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Integrating“wellness”into your business isnt a novel concept.It has been the hot button topic for decades.To be well is one of the most aspirational human states,and every brand is hunting for their unique way to get a slice of the billions of dollars sized pie.Whereas years ago,it may have sat as an identifiable category dominated by skincare,salt baths,meditation it has become increasingly nuanced and has proliferated every category.Consumers now expect to have deep and unprecedented access to brands that make them more well.Examining the ways that the wellness movement will continue to reinvent products,services,and experiences across categories.IntroductionHeres the big question:When wellness becomes an increasingly elusive,yet integral part of customer experience,how do brands respond and prepare for the demands of the future?Lets take a closer look.Clear M&C Saatchi|Beyond Wellness 20402Weve brought a fresh perspective to the future before.From Beyond Retail 2030To Beyond Travel&Hospitality 2030There is an art and a science to predicting whats ahead and while 2030 is exciting,2040 is what we need to be preparing for in wellness.Clear M&C Saatchi|Beyond Wellness 2040Introduction34And were willing to make a few big bets on the future of the wellness category as we look to 2040.1.It will encompass at least 5 more industries2.It will have redefined the concept of personalization and vitality3.It will be driven by scientific and technological advancement 4.It will be a“how”not a“what”;todays approach will be made more active5.It will be the defining factor for whether brands are considered consumer-centric,or notIntroduction4Clear M&C Saatchi|Beyond Wellness 20405.Be WellHow to bring wellness into your brand authentically and remain future-proofed 2.ExamineLets figure out what essential elements are at playContents1.PrepCleanse and prime yourself to have an open mind 3.DiagnoseTime to pinpoint whats happening in wellness4.TreatWhat your brand needs to consider to be well ahead of the competitionClear M&C Saatchi|Beyond Wellness 20405PREP16Clear M&C Saatchi|Beyond Wellness 2040PrepWellness is a modern,commoditized way of life with an ancient origin.It began as an Eastern practice that viewed health as a sum of parts:mind,body and soul.Each only as strong as the other,shaped by systems of medicine,exercise and hygiene intended to deliver ultimate well-being.“Wellness can be traced back to 3,000 BC.Around this time,the holistic system of Ayurveda began in India.Ayurveda means”the science of life“and comes from the ancient spiritual philosophies of the Vedas.It sought to balance mind,body,and soul while seeking to prevent illness.”Clear M&C Saatchi|Beyond Wellness 20407PrepBefore wellness,health in the US was a static binary ill or not ill.Clear M&C Saatchi|Beyond Wellness 2040Meanwhile across the Meanwhile across the world,Western culture world,Western culture treated health in scientific treated health in scientific black and white.black and white.8Prep50%Around 50%of US consumers now report wellness as a top priority in their day-to-day livesClear M&C Saatchi|Beyond Wellness 20409The past few decades witnessed growing acceptance of wellness in Western culture.It became sought after as a pathway towards self-actualization one achieved through immense investment in oneself.PrepBuying-in was a status symbol and unattainable for most and yet it grew.And grew.$5,300The average yearly spend on wellness by AmericansClear M&C Saatchi|Beyond Wellness 204010Curiosity towards betterment formed the foundation for a booming market that ventured far beyond traditional techniques,into a sea of wellness-ified products and services.Enter 2019,the bubble was ready to pop.The US housed a fragmented market of superfluous wellness offerings,accessible only to those with the luxury of time,money or perfect health.But the 2020 global health crisis catalyzed the wellness market,already primed for reinvention,to re-root itself in the essentials.PrepWellness became access to:Doctors&Doctors&medical medical treatmentstreatmentsFood,water,Food,water,and cleanliness and cleanliness productsproductsEmployment and Employment and minimum wageminimum wage62%of US consumers agree that their health is more important to them now than before the pandemic according to the World Economic Forum.Clear M&C Saatchi|Beyond Wellness 2040Now,at every income bracket,priorities look virtually the same.11PrepThis societal shift prompted the category to restructure itself around emerging consumer benefits:practical,accessible,empowering.These became the new rules to follow.But the poles of wellness never disappeared theyre just manifesting in different ways:prestigious,avant-garde wellness experiences continue to push boundaries,or consumer-centric brands operate meaningfully to ensure inclusive and integrated wellness.Every-dayExtremeClear M&C Saatchi|Beyond Wellness 204012PrepClear M&C Saatchi|Beyond Wellness 204013There are two polarities that exist today:The challenge for brands is identifying where they sit on that spectrum and how to execute wellness in line with their core ethos.Extreme wellness Extreme wellness has its niche,while everyday experienceseveryday experiences albeit less sexy hold broader commercial sway.$480BSize of the US wellness market(USD)in 2024 according to McKinsey,with a growth rate of 5 to 10 percent a year.PrepTheres a right way for your brand to do wellness,and we can bring clarity to it.We are confident that the opportunities we examine will drive the next generation of growth for the wellness economy.Projected to climb to$8.5 trillion by 2027,ensuring huge runway to 2040,the ecosystem is expanding.Your brand has a right to own a piece,but success will hinge on how you do it.2022 Global Wellness Economy2040 Global Wellness Economytechnologytravelfinancialinstitutionsmediahome&hygiene workplacehealthy eating,nutrition&weight Losspersonal care&beautyphysical activitypublic health,prevention&personalized medicinetraditional&complementary medicinewellness real estatespringsspasmental wellnesswellnesstourism14Clear M&C Saatchi|Beyond Wellness 2040Clear M&C Saatchi|Beyond Wellness 2040EXAMINE215We see 10 big opportunities emerging across four unique innovation pathways that will shape the future of the wellness economy.ExamineConsumers will increasingly feel empowered to have control over the length and quality of their lives it will no longer be up to chance or the unpredictable.Longevity can be altered and extended in measurable ways through medical and lifestyle treatments.The daily experience of lifes highs and lows has taken on new meaning in a world filled with exponential positive and negative stimulation from extreme and accelerating climate changes,to experiencing the joy and pain of others tenfold through social media consumers are looking for mechanisms to preserve their holistic wellbeing.Consumers exist within a set of learned behaviors due to their lived experiences and surroundings,and many can often be at odds with advancing beyond their baseline health.People will explore incrementally improving their wellbeing through new norms and rituals grounded in the power of avoidance,resistance,and going against the status quo.Consumers and businesses are considering how wellness can transform more than just a practice in their lives,or a product that they use it is becoming a way of life that has the power to lead to a renewed way of living and operating.It is a future state we predict to see embodied.Clear M&C Saatchi|Beyond Wellness 2040ImprovingLongevityManaging VibrationsUnwinding&Resetting BehaviorsExperiencing Transformation6Societal Wellness9Secure Living7NaturalConnectivity5Environmental Bonds2PeakPhysicality3Nutr(you)tion4The Female Health Precedent1Quantified Medical Self168GoodVices10RenewalMetamorphosisHome&Hygiene3.Food&Beverage4.Technology5.Workplace8.Travel7.Pharma6.FinancialInstitutions9.Media10.Were going to bring these 4 innovation pathways to life in these 10 spaces by exploring ways different categories could unlock their value near and long term.Healthcare2.Beauty&Personal Care1.Clear M&C Saatchi|Beyond Wellness 204017Clear M&C Saatchi|Beyond Wellness 2040The greatest barrier to adoption of“new”is human resistance to new behaviors or routines,thus seamlessness should be a top-of-mind execution lever.Seamlessly integrates into customer lifestylesAccessibility is impacted interchangeably by price,availability and knowledge optimizing each ensures wellness can be attainable for everyone.Accessible to a broad spectrum of customersTime is highly valuable;product adoption will hinge upon simple and intuitive practices that garner approbation into daily routines.Requires minimal timeFrom blood tests to biological skincare to sustainable living,consumers want and expect to see initiatives that improve their current health to aid in longevity.Elevates baseline healthWhile more facets of healthcare are exploring womens health specifically,products and services that celebrate all stages of life at puberty,pregnancy,and menopause excite and empower female consumers.This applies as well to underserved demographics who in the past may not have had the buying power or accessible entry point into wellness categories.Addresses underserved demographics needsAsking provocative questions through the lens of the following experience principles that are essential for incrementally increasing consumer entry into the category and driving penetration.Examine18Clear M&C Saatchi|Beyond Wellness 2040DIAGNOSE3191Quantified Medical Self4The Female Health Precedent3Nutr(you)tion2PeakPhysicalityClear M&C Saatchi|Beyond Wellness 2040Improving LongevityConsumers will increasingly feel empowered to have control over the length and quality of their lives it will no longer be up to chance or the unpredictable.Longevity can be altered and extended in measurable ways through medical and lifestyle treatments.20Innovation Pathway#1Quantified Medical SelfFrom doctors as the gatekeepers of consumer health,to consumers as practicers and practitionersOpportunity#1The next generation of optimized health and medicine will be defined by consumer control as they look to find sustainable solutions for increasing quality and length of life.With the widespread adoption of wearables(moving towards bio-wearables),at-home diagnostic testing,and preventative services,consumers have increasingly felt capable of learning and making choices about their daily and extended health a choice historically guided and guarded by doctors.With a wealth of information at their fingertips,consumers are becoming practitioners,whether we like it or not,and brands need to be there to support them in this new era.Consumers in control will be the future baseline.Doctors and brands should expect to deliver dynamic,actionable data and work with them,not for them,to help them achieve their longevity goals.And in turn,consumers will be controlling the innovation narrative,as they have with the rise of Ozempic and products like it to finally acknowledge the obesity crisis,or the exponentially booming sleep aid and therapies market for the invisible disease of insomnia.Consumer ailments and quality health inhibitors that have been deprioritized by brand and society for being unsexy or taboo are becoming visible with quantified self data and technologies that are creating the capability for truly augmented humans.Ones health monitoring and optimizing will be always-on there will be no more hiding.Stats and Signals$360BHome healthcare market size valued n 2023(USD)and expected to grow at a CAGR of 7.96%from 2024 to 2030.1Americans use a wearable device to track their health and fitness.Among these wearable users,80%would share information from their device with their doctor to support health monitoring2$158BSleep aid market size value(USD)by 2032,expecting to grow at a CAGR of 7.04%over the next 8 years3 1 in 31.Grand View Research,20232.National Heart,Lung,and Blood Institutete,20233.The Brainy Insights,2023Clear M&C Saatchi|Beyond Wellness 204021Quantified Medical Self In MarketHealthcare with humans in mind.PrenuvoPrenuvo introduced consumers to a new wave of healthcare technology;the referral-less MRI.With optimized hardware,state of the art software,and future enhancements with AI,the Prenuvo MRI can detect cancer and other abnormalities earlier to give consumers the head start they need.For a one-time cost,Prenuvo offers consumers a stress-free health experience and instead welcomes patients ona transformative journey connecting humans and their health like never before.All-in-one testing.For everyone.Function HealthFunction Health offers consumers access to hundreds of health tests;from heart and thyroid to Alzheimers risk and hormones.Through a simply application and set fee that is both FSA and HSA eligible,Function Health is paving the way in ownable health.Through a membership style system,Function Health gives consumers unprecedented access and guidance of what to do with their own health data.The Semaglutide supremacy.Ozempic&WegovyThe FDA approved weekly injection to help combat type 2 diabetes,obesity,and heart health has taken over.By empowering consumers to feel in charge of their own wellbeing and appearance,semaglutide injections offer these consumers weight loss treatments in the comfort of their own home.Companies like Ozempic and Wegovy have established themselves as an early force in the world of accessible healthcare for weight loss.Clear M&C Saatchi|Beyond Wellness 204022Opportunity#1Imagine ifThere were“Ozempic”equivalent solutions for:diabetes,insomnia,hair loss,arthritis.etc.?Pharma&HealthcareMedications could be formulated on-demand for each individual make-up to perfectly target their needs?A home could serve as the exam room and testing center monitoring and diagnosing consumers daily without interruption until a medical concern arises?Home&HygieneTechnology could diagnose a persons emotional health to support them through flourishing,thriving,resilience and burnout?TechnologyBio-wearables flagged signs of illness weeks before symptoms to get proactive treatment?Resulting in less nurse and doctor burn out?Clear M&C Saatchi|Beyond Wellness 204023Opportunity#1Quantified Medical SelfWhat categories are most primed to disrupt or be disrupted by this opportunity?Stats and Signals$89.8MProjected global home-use beauty devices market value.Expected to advance at a CAGR of 26.1%from 2022-2030.1The melding of wellness and beauty will only become more pronounced in the years ahead,in line with an expected CAGR of 10%to 2027 for the wellness industry.This trend will represent an untapped opportunity for many,with first-mover advantage for the players that get it right.282%Of US consumers consider wellness a top or important priority in their everyday lives;purchasing more wellness products and services across health,sleep,nutrition,fitness,appearance,and mindfulness than before.3 1.Prescient Strategic Intelligence,20232.McKinsey&Company,20233.McKinsey&Company,2024“Each day,the idea of the fountain of youth seems more possible,thanks to biohacking and innovative next-gen solutions that promise a youthful appearance,feeling,and even physical ability,at all ages.Transformation of the body for vanity is at an all time high.MedSpas and cosmetic procedures are getting a lot of attention,with both consumers and forward-thinking entrepreneurs making significant investments.But were also seeing consumers increasingly making the connection between a beautiful exterior with a higher functioning interior;for example,clear,elastic skin may translate to higher functioning facial muscles that prevent symptoms of aging like speech or sight impediments.And consumers also expect these results to improve their physical appearance and functionality in real time.The wave of tools and techs like the LOral Skin Genius AI app,FaceGym,or Lyma demonstrate that problems can be diagnosed and addressed with near instant solutions quicker than ever before and more affordably.Brands and consumers are also fearlessly addressing the previously un-addressable:reversing grey hair(Arey),striving for professional athletic performance as an average Joe(AG1,CrossFit Games),and feeling 15 at 71(Wendy Ida).Physical limitations are being remapped,and achieving the look youve always wanted is within reach.Looking and feeling like a whole new you wont be an empty marketing promise in the future it will be a startling reality.Peak PhysicalityFrom the desire to look and feel better hair,skin,nails,figure,fitness to investments in looking and feeling better that also result in performing better Clear M&C Saatchi|Beyond Wellness 2040Opportunity#224Aging Fearlessly.Modern AgeModern Age offers consumers the power to slow down the process of aging,both inside and out,with tests designed to detect biological age,fertility,weight loss and much more.From the Aging Wellness blood test results,Modern Age develops optimization programs with clinicians on treatments,OTC supplements,and diet recommendations to improve both mental and physical wellbeing.By reducing the stressors of aging,consumers can continue living confidently regardless of their age on paper.The boxing bag with a brain.BhoutWith the emergence of innovative at-home exercise equipment and technology,Bhout is pushing the boundaries of boxing,with a boxing bag enhanced with AI technology to mimic boxing with a human.With inclusivity at the forefront of their values,Bhout is making boxing accessible and approachable.Bhout has differentiated themselves as an early innovator in the space,taking the intimidation out of going to a workout class and bringing it to the comfort of your own home.Exercising done for you.EmsculptWith advanced body contouring technology,EmSculpt allows customers to kickstart their fitness journey.Through HIFEM,targeted muscles engage and contract similarly to how they would during strenuous exercise.EmSculpt is pushing the boundaries of body toning with technology that can permanently destroy fat cells,giving customers the body confidence they desire.Eliminating the need for physically rigorous exercise to achieve desired results,EmSculpt offers a solution that takes the work out of workout.Peak Physicality In MarketClear M&C Saatchi|Beyond Wellness 2040Opportunity#225Imagine ifMedical grade skincare and cosmetic treatments could be done safely and with the same efficacy at home by consumers?Beauty&Personal CareSkincare systems could not just reduce signs of aging,but shave off decades of visible damage?HealthcareTools and treatments could truly replace the need to exercise,and deliver even better physical results both mentally and physically?TechnologyBiological age could be a choice?And entire systems existed to support this journey?Completely safe pregnancies could occur into a womans 40s and 50s?Clear M&C Saatchi|Beyond Wellness 2040Opportunity#226Peak PhysicalityWhat categories are most primed to disrupt or be disrupted by this opportunity?Stats and Signals$177.5BDietary supplements market value in 2023(USD)and projected to grow as CAGR of 9.1%from 2024 to 2030.1A growing interest in the field of nutrigenomics is being supported by the rising awareness regarding the influence of diet on human health and its potential,with respect to minimizing the risk of various diet-related diseases,including diabetes,cardiovascular disorders,chronic respiratory diseases and oncological disorders.2$61.3BProjected size of the global vegan food market in 2028 plant and expected to grow at a CAGR of 12.9tween 2021 and 2028.31.Grand View Research,20232.Roots Analysis,20233.World Animal Foundation,2023“Nutr(you)tionFrom prescribed,subscribed,or read diets and recommendations that require constant consumer participation,to intuitive,predictive,and managed nutrition and eating systems for optimal health at all life stages Clear M&C Saatchi|Beyond Wellness 2040Opportunity#327A diet has historically conveyed the limitation of food,but the word is being reclaimed.New technologies and medical progress are enabling democratized access to personalized diets.These optimized and additive diets are becoming crucial for long-term health.Were seeing 3 big areas of advancement:genetic personalization,accessibility,and connectivity.Scientific advancement is creating solutions like Epigenetic nutrition,which explores how specific nutrients and bioactive compounds in the diet can modulate epigenetic processes including development,aging,and disease.In short,there is a future where nutrition solutions are created around DNA makeup.Bio-wearables offer ways to action this,potentially automating the detection and tracking of food consumption to guide the consumer on adjustments to reach set goals whether thats weight loss,extended age,better vision based on their genetics unique microbiome.And consumers are responding:they want access.Access to the best nutrition plans,and health-boosting food regardless of their economic status still a far-off dream from today.But why stop at food when we know theres also a booming supplements market attempting to make-up for the lackluster nutrient-dense food offerings.The throughline across all this innovation is connectivity.Consumers want to know exactly what to take and when that needs to change as their health and age does making the future of services,IOT,supplements,etc.living offerings so that consumers can be agile in making diet adjustments to live the happiest,longest life.Complete nutrition in one dose.AG1AG1 is designed to help customers build healthy daily habits through a once daily scoop that has all the necessary multivitamins,probiotics,superfoods,immune and cognitive support.Taking away the added pressure of taking many daily supplements,customers report AG1 has had a positive impact on their energy,digestion,and stress levels.AG1 supports consumers to confidently move forward in life feeling nourished and energized in their own bodies.Continuous health monitoring.LevelsHarnessing the power of the advanced continuous glucose monitoring(CGM)models,Levels offers its consumers access to CGM with real-time results.Through a patch that attaches to your upper arm for 10-14 days,Levels can read glucose data and offer insights on how lifestyle affects your health.With data-driven nutritional guidance and personalized trends,Levels utilizes consumers glucose and biomarkers to help optimize diet,sleep,and exercise,giving consumers real-time results about their health.Eat according to your genes.NutrigenomixNutrigenomix is pioneering the genetic testing space with personalized nutrition plans based on real-time results.Through health,sport,and fertility tests,Nutrigenomix can provide genetic backed results on weight management,food intolerances,injury risks,and fertility optimizations.Through partnerships with healthcare providers,Nutrigenomix offers consumers personalized recommendations on diet,supplements,and lifestyle changes all according and tailored to your genes.Nutr(you)tion In MarketClear M&C Saatchi|Beyond Wellness 2040Opportunity#328Imagine ifHigh-quality,nutrient rich produce was accessible and affordable in every neighborhood in the US?Diets were determined by a persons DNA?Wearables could sync with bodily-health needs and goals like weight less or muscle gain to in real-time inform when and what to do:eat,exercise,sleep,etc.to reach them?Smart fridges could sync up to wearables to help plan weekly meal routines based on nutritional needs?The nutritional makeup(calories,carbs,sugars,etc.)of a popular food item,like a loaf of bread,could be instantly adjusted to an individuals needs at the grocery store?Food&BeverageHome&HygieneTechnologyClear M&C Saatchi|Beyond Wellness 2040Opportunity#3What categories are most primed to disrupt or be disrupted by this opportunity?Nutr(you)tion29Stats and Signals8 in 10Women are not diagnosed with Menopause;6 in 10 are not diagnosed with Endometriosis;2 in 10 are not diagnosed with PCOS.1Despite recent growth in the womens health space,there is still unmet demand for products and services.Menopause has been a particularly overlooked segment of the market:only 5 percent of FemTech start-ups address menopause needs.21%Only 1%of healthcare research and innovation is invested in female-specific conditions beyond oncology.3 1.World Economic Forum,20242.McKinsey&Company,20243.McKinsey&Company,2022“The Female Health PrecedentClear M&C Saatchi|Beyond Wellness 2040From a healthcare system designed around men and that historically disregards womens most vulnerable states,to a complete reallocation of funds,research,and care to supporting women through their hormonal and life stage journeys Opportunity#4The stage is being set for an entirely new ecosystem of not just services and products,but priorities from brands,the medical community,and society,to acknowledge and address womens health needs across her entire lifecycle.From puberty,to fertility and the 4th trimester,to raising children,to sexual health,to menopause and the entire process of aging and changing through these phases women are finally being seen.The scientific community is up in arms at studies that have shown puberty is starting earlier leading young girls to have a higher risk of depression,anxiety,substance abuse and even developing cancer in adulthood.And they dont yet know why.A problem once dismissed is getting the attention of experts around the world.Simultaneously fertility treatments and support for women post-birth is on the rise even as it continues to be a tumultuous topic as governments across the US continue to debate whether women should have autonomy over their bodies.IVF,abortion:there has never been so much access and support for them,while also receiving the most backlash.Sexual health is also turning a chapter with a breadth of products and services designed for womens pleasure,not men.Weve even gone so far as to remove the onus on women to manage pregnancy,with the first FDA approved male contraception entering the market.Sexuality and sexual health is being explored and encouraged at all different stages of life especially as women reach menopause and face a whole new set of challenges.Hormone replacement therapy and medical procedures have been the standard but are being challenged by consumer-centric options that prioritize the wellbeing of the woman to treat her with greater care.Womens health is not just the next big tidal wave its going to flip the medical and consumer fields on their heads as the dynamism of women takes the world by storm.30Slow your child from growing up.Lupron Depot-PedThe controversial Lupron Depot-Ped helps to control early onset puberty,or CPP,through a twice-yearly injection that stops the release of puberty hormones.With growing concerns that children with CPP will develop bone and emotional well-being issues,Lupron Depot-Ped has been a trusted solution by parents for over 30 years.While parents cannot control everything their kids do,with Lupron Depot-Ped,parents can protect and help their kids stay kids for longer.Give an egg,get yours free.CofertilityCofertility is modernizing fertility and womens reproductive health through a human-centered egg donation experience.With core values around accessibility and affordability,Cofertility offers free egg freezing solutions when donating half to a family who cannot conceive,making starting a family possible for all.By empowering women and families along the journey of egg retrieval and freezing,to donation and implantation,Cofertility is breaking the antiquated stereotypes of modern-day egg donation.Skincare for pregnancy.Mama MioMama Mio has developed skin care for pregnant women through every stage of their pregnancy journey.With all natural creams,butters,washes,and oils to help with stretchmarks,breasts/breastfeeding,and dry skin,Mama Mio is on a mission to make caring for your skin easy and accessible along the pregnancy journey.With the physically and mentally taxing motherhood journey ahead,Mama Mio looks to empower women through supportive and nourishing skincare.Clear M&C Saatchi|Beyond Wellness 2040The Female Health Precedent In MarketOpportunity#431Imagine ifHormone trajectories could be identified at birth to determine the rate of puberty in adolescents?Exact menopausal age could be detected through tests to tailor programs and medication to alleviate stress and depression?There was mandated maternity and paternity leave for at least 6 months?Skincare systems were designed to help treat the underlying symptoms of menopause from the outside-in?Egg freezing and retrieval was widely available in every US state?The period post-partum had a suite of products and services dedicated to helping mom reclaim her identity?On-site childcare and breast-feeding rooms were in every office building?HealthcareWorkplaceBeauty&Personal CareThere were separate dedicated sick days related to female health issues like periods or post-partum depression?Clear M&C Saatchi|Beyond Wellness 2040The Female Health PrecedentOpportunity#4What categories are most primed to disrupt or be disrupted by this opportunity?32Clear M&C Saatchi|Beyond Wellness 20405Environmental Bonds6Societal Wellness33Innovation Pathway#2Managing VibrationsThe daily experience of lifes highs and lows has taken on new meaning in a world filled with exponential positive and negative stimulation from extreme and accelerating climate changes,to experiencing the joy and pain of others tenfold through social media consumers are looking for mechanisms to preserve their holistic wellbeing.Stats and Signals4.3MAcres of land,nearly the size of Connecticut,will be underwater by 2050,including$35 billion worth of real estate.1The impact of current environmental issues not only impacts our physical health but also our mental health.These earth conscious consumers feel emotionally drained while imagining the future of themselves,their families and future generation.The situation of the environment and the high level of pollution is a major concern at the individual level,and collectively for policymakers,marketers,and society.2108%Increase of electric vehicle sales from 2020 to 2021.Electric vehicle sales in the US could account for 40%of total passenger car sales by 2030.31.Scientific American,20222.Wiley,20233.J.P.Morgan,2023“From caring for the planet as a nice to have,to committing to environmentally led initiatives,products,and experiences because human wellness and a well planet are becoming increasingly interdependentClear M&C Saatchi|Beyond Wellness 2040Opportunity#5Environmental BondsPersonal wellness is increasingly becoming dependent on a well planet.Investing in environmentally friendly products,services and experiences isnt just a way for brand and consumers to do their part doing the good makes people more well.While many businesses and consumers are embracing environmentalism as a core tenet the narrative is evolving:not taking care of the planet is detrimental to human health.For the good all,but even more so for their own good,people are helping the planet to help themselves.Eco-anxiety has consumers looking for solutions to their rapid changing environments,whether that is wildfires displacing people from their homes,extreme heat causing psychiatric medications to affect bodily temperature regulation,to increasing rainfall that leads to less sunlight the key promoter of our production of serotonin.The reality is people are living with real fear for their bodily health and want to find ways to help the planet to mitigate the effect on them.People are investing in smarter ways of living to do so.With a huge decrease in habitable land predicted by 2040 due to natural disasters and rising seal levels the future of housing to achieve quality of life is under great debate.Were seeing smaller investments in personal wellness with surges like the rise of EVs.Cars were never previously considered a wellness product,but today they are.This growing desire for consumers to adopt a benevolent and planet-kind lifestyle that is still about high-performance,a key function of wellness,shows new ways the category can expand.34Prestigious,sustainable mobility.RivianWhile on a mission toward net-zero carbon emissions by 2040,Rivian is transforming the electric car market.Rivian is engineering efficient vehicles with batteries made of ocean-bound plastics and with low cost direct-to-consumer models,sustainability is at the forefront of the business.With another goal to make electric vehicles more accessible,through a partnership with Tesla,Rivian consumers will have access to the Tesla charging network,broadening the benefits of owning a Rivian.City designed for climate change.NusantaraDue to the over-extraction of groundwater,Indonesias capital,Jakarta,is rapidly sinking,and a new city is being built as a replacement.Nusantara,meaning“archipelago”in Javanese,will become Indonesias new capital city in 2045.The city will be powered with renewable energy with protected forestry on the island.Nusantara will be an economic driver for Indonesias future and a symbol of national identity,setting an example of how to build the future of living,while protecting our earth.Sustainability stewardship.John DeereAs consumers have become more cognizantof sustainability,they expect companies and brands to deliver on the promise of saving the planet and John Deere is exceeding expectations.From the John Deere foundation supporting the One Acre Fund to help promote soil health in sub-Saharan Africa to developing smarter spraying tech to reduce non-residual herbicide use,John Deere is putting the planet first.With investments in education,John Deere is inspiring agriculture students through job shadows,mentoring programs,and apprenticeships;making it more accessible to help the planet.Environmental Bonds In MarketClear M&C Saatchi|Beyond Wellness 2040Opportunity#535Imagine ifTransportation companies(e.g.,Amtrak,United,Uber,etc.)published annual goals for positive impact and charted individual contributions,along with financial incentives?Personal transportation,like cars,was widely powered by renewable energy(e.g.,solar,marine,wind)?Our devices could predict our“offset”via our consumption in the future and not just reward with emotional benefits,but tangible ones?Retailers and producers worked together,and each benefited,to create a more globally responsible food chain focused on reducing consumption waste?TravelFood&BeverageTechnologyReusable packaging didnt just become another item in your home,but a tool for generating income?Clear M&C Saatchi|Beyond Wellness 2040Environmental BondsOpportunity#5What categories are most primed to disrupt or be disrupted by this opportunity?36Stats and Signals$375BValue of the global mental health market in 2022(USD)with a forecasted CAGR of 3.85%from 2023 to 2030.1As reported by the American Psychiatric Association,unresolved depression accounts for a 35%reduction in productivity.It contributes to a loss of$210.5 billion a year to the US economy in the form of productivity loss,medical costs,and absenteeism.In fact,depressed employees miss an average of 31.4 days of work per year leading to reduced effectiveness and costly mistakes.213%The risk of depression increased by 13%for each hour increase in social media use in adolescents.31.Yahoo Finance,20232.Berkeley Exec.Ed,20223.National Library of Medicine,2022“Individual wellness journeys,from healthy aging to mental health,will become increasingly supported by large scale,organizational movements to address the scale in which individuals are all experiencing similar,compounding challenges.Wellness has always been grounded in personal growth and betterment.That is still true demonstrated for example by todays booming gut health and sleep aid market.Those are generally not“us”problems,but“you”problems companies can target and address.But many experiences or problems are shifting from being individually addressable to requiring systematic solutions as they affect such a great portion of our society.From the loneliness epidemic,a youth population with the highest rates of depression and anxiety,global religious unrest,domestic and international political uncertainty companies and brands have a chance to exponentially improve wellness ambitions of the individual but working to solve for the whole.When we consider the rise in depression and anxiety in our youth,how can brands think ahead to the downstream affects of this.How do we help an entire generation already struggling to be ready to enter the workforce?Become a parent?Key factors impacting these major societal shifts are social media affecting receptors for empathy,emotion and communication skills,a rise in remote work,education on global strife tipping scales into overconsumption,and a fear of socioeconomic impacts.Companies have a chance for 5x the impact and scale when designing their offerings for a greater whole.Clear M&C Saatchi|Beyond Wellness 2040Opportunity#6Societal WellnessFrom individual solutions for self-care wellness journeys to societal wellness offerings that address the scale of individual problems,to create healthier,happier populations in an increasingly complex world37Societal Wellness In MarketReal healthcare at work.HealthwiseAs employers take on a more important role of providing employees with more accessible health care,Healthwise offers services that helps patients and members feel seen and heard.With services and content centered around every life milestone,from parenthood to understanding the symptoms of a heart attack to supporting mental health literacy,companies like Healthwise are becoming the standard in the workplace.Long gone are the days of traditional health insurance as mental and physical wellbeing are becoming the table-stakes for their employers to provide.Gift your heartbeat.The TouchIn a modern world where family,friends,and loved ones are often separated by distance,The Touch enables users to share their heartbeat with those they love.In the form of a necklace and ring,The Touch records a users heartbeat which they can send to the recipient through an app,which can be felt through the jewelry.In moments of loneliness and longing,The Touch brings its customers one beat closer to those they love and miss.The smart jewelry is designed to be passed to future generations,so a heartbeat can last a lifetime.Improving mental health for all.Project AWAREWith mental health programs becoming commonplace at schools,Project AWARE(Advancing Wellness and Resiliency in Education)is pioneering the challenge with a program that builds collaborative partnerships with local agencies to provide better mental health care and awareness to students,teachers,and parents.Project AWARE has successfully made 1,117 policy changes from 2018 to 2023 that improve mental health programs at the state and local levels.Advocating for and improving mental health literacy will only become more essential among schools and communities.Clear M&C Saatchi|Beyond Wellness 2040Opportunity#638Imagine ifWearables could identify levels of dopamine,serotonin,and monoamine oxidase A to access mood and notify a health professional of when a depressive episode hits?News channels and magazines had mandated guidelines around content distribution that focused on maintaining the mental health of viewers?Mental health awareness,education,and support was offered for free by every employer and school system?US companies covered all healthcare costs for employees,outside of the insurance policy?TechnologyHealthcareMediaThe smartphone could identify your mental state by the social content youre receiving and recalibrate to happier content to drive positivity?In the case of children,alert parents?Clear M&C Saatchi|Beyond Wellness 2040SocietalWellnessWhat categories are most primed to disrupt or be disrupted by this opportunity?Opportunity#639Clear M&C Saatchi|Beyond Wellness 2040Unwinding&Resetting BehaviorsConsumers exist within a set of learned behaviors due to their lived experiences and surroundings,and many can often be at odds with advancing beyond their baseline health.People will explore incrementally improving their wellbeing through new norms and rituals grounded in the power of avoidance,resistance,and going against the status quo.407NaturalConnectivity8GoodVicesInnovation Pathway#3Natural ConnectivityFrom screens,online,and AI as predators to human connection and healthy lifestyles,to delivering enhanced experiences by bringing together the best of tech and the natural world for a new set of health benefits Stats and Signals$65.5BEstimated size of the global metaverse market size in 2022(USD)with a forecasted CAGR of 41.6%from 2023 to 2030.1Advances in virtual reality devices and high-speed connections,combined with the acceptance of remote work during the COVID-19 pandemic,have brought considerable attention to the metaverse as more than a mere curiosity for gaming.But the future of the metaverse remains uncertain:its definitions and boundaries alternate among dystopian visions,a mixture of technologies and entertainment playgrounds.2.1.Grand View Research,20232.Nature Human Behavior,2023“There is no denying screen-free outdoor time is good for the soul.And arguments on the detriment of online time have been worn out.The new news:there is innovation to be done in amplifying and creating new benefits derived from the natural world when paired with technology,versus seeingit as the adversary.The key unlock here:when utilizing the power of both nature and technology there is opportunity to facilitate greater,deep human connections and foster empathy.Standalone,technology has proven it can have a negative effect on developing brains.Too much screen time can affect our ability to empathize and connect with others and the natural world.When thinking about supporting our future generations,this is paramount to address.We also know people are burnt out from being online,going to the extremes to remove it such as taking unplugged vacations with only technology untouched by modern connectivity like polaroid cameras.Were seeing this solutioned for in many ways for people of all ages.From metaverse manifestations of nature that give people greater access to nature from the comfort of their home,to“technological nature”of 360-degree environments that allow people to“inhabit”remote natural wonders few will witness themselves,to translation devices that allow us to understand the communications of the natural world imagine being able to understand what a whale was saying in your own language.Creating experiences around nature that utilize technology can give consumers unprecedented access to the natural world,to really talk to nature.It strips away the feeling of remoteness or fear,replacing it with human inspiration,excitement,and optimism.It transcends humanity and nature.Properly utilizing technology means we can truly connect to nature,not just be in it or study it.Clear M&C Saatchi|Beyond Wellness 204041Opportunity#7The future of urban living.NEOMFrom the mountains of NEOM across the desert valleys in Saudi Arabia,THE LINE,a community development project will accommodate 9 million people and will run on 100%renewable energy.As the worlds population grows rapidly and habitable land area diminishes,THE LINE will take up minimal space in a currently uninhabited area and provide its residents with the upmost efficiency.By 2045,there will be 9 million residents of THE LINE with more access to nature,loved ones,and improved infrastructure,citizens of THE LINE will tackle the challenges facing humanity in urban life today.Conversations with animals.Earth Species ProjectUsing AI and machine learning,the Earth Species Project is on a mission to understand more than just the human language.With research projects underway studying animal vocalizations in birds,foundational models can be built and trained with AI to establish a way of communication through semantic generation of signals.While in its infant stage,the Earth Species Project has a roadmap to deliver two-way communications with different species in the future.Tapping into the metaverse.Apple Vision ProAs consumers seek out more digitally immersive experiences,Apples Vision Pro makes this a reality through spatial computing.With the ability to watch entertainment in 3D,make FaceTime calls to friends,co-workers,and healthcare professionals,and surf the web,interacting digitally has never been easier.With the rise of VR headsets made more specifically for gaming,Apples Vision Pro pushes the boundaries further as we migrate to a world of interacting with and in the metaverse.Clear M&C Saatchi|Beyond Wellness 204042Opportunity#7Natural Connectivity In MarketImagine ifNatural ConnectivityVeterinary professionals could communicate and diagnose pain in animals through breathing and voice pitch frequencies?We could transport people who are unable to travel via the next-gen of AR/AI technology that allowed them to not just see and hear,but feel experiences i.e.wind,rain?You could harness the healing nature of trees to treat illnesses(i.e.anxiety,hypertension)by literally becoming one with their electromagnetic frequencies in their connected root systems?Recreate remote natural environments like the humidity of a rainforest and the cold and salinity of a fjord i.e.real steam to cold plunge?TechnologyTravelHealthcareClear M&C Saatchi|Beyond Wellness 204043What categories are most primed to disrupt or be disrupted by this opportunity?Opportunity#7There were AR contacts that put more greenery and animals into your daily vision?Stats and Signals1.2BGlobal non-alcoholic beverage market size in 2023(USD).Projected growth of CAGR 7.4%from 2024 to 2030.1With trends such as“Dry January”and being“sober curious”dovetailing with the larger wellness movement,the demand for nonalcoholic beverages is on the rise.In 2021,the dollar sales of such beverages which include mocktails and alcohol-free beers or wine increased about 33 percent compared with 2020.At the same time,theres also been growing interest in“functional beverages,”or nonalcoholic drinks that make health claims.2.87%Of Americans agree that they would like to take steps to live healthier for longer,and that they want to know the secrets to living and feeling younger than their calendar age.31.Grand View Research,20232.The Washington Post,20223.Ipsos,2022“Good VicesFrom villainizing vices like alcohol or caffeine and focusing solely on alternatives,to removing the friction and compromise behind better choices so vices become a more intentional part of a healthier lifestyle Clear M&C Saatchi|Beyond Wellness 204044Opportunity#8The booming vice-alternatives market is trendy today,but it doesnt reflect a representative future.The truth is,humans need ways to reward and unwind-and their traditional vices fit the bill.So,rather than completely replacing their beloved vices,people are hungry for them to get a makeover,where its still possible to indulge in guilty pleasures without compromising physical and mental health.Wellness is often framed as adding positive enhancements to ones life,but its also about evaluating what bad behaviors,products,and mentalities exist and growing away from them.People are seeking easy to integrate,enhancing resets that do not feel like a sacrifice to their current lifestyle.Many vices(besides those that are life threatening or illegal)dont need an overhaul,they need a reframe.They need moderation techniques,they need healthier benefits,and they need to be facilitators rather than disruptors of creating better relationships with moments that matter,like connecting,socializing,and relaxing.Todays blanket approach to vices is remove and replace.The booming weed,psilocybin,and alcohol-alternatives markets are proof people are seeking ways to enjoy life without the negative aftereffects.But the framing of today limits the future of the category where age old behaviors that are unlikely to change,like a beer after work,doesnt have a place.Instead,greater access to managed vices and serving their underlying needs can be a solution.For example,the need to feel more comfortable socializing with colleagues might facilitate the growth of the psilocybin market.Versus todays rhetoric primarily driving the markets growth I want to party without the guilt.But that places blame on the consumer,and limits innovation.The alternatives market is undeniably growing and will continue to as it fits many lifestyles especially Gen Z,but the real opportunity may lie in empowering vices to be had in healthier ways,and considering what unchangeable human behaviors have the greatest opportunity for positive disruption.Synthetic alcohol.GABA LabsWith consumers seeking alcohol-free products,GABA Labs has developed a set of ingredients known as“Alcarelle”,designed to give social drinkers what they want from alcohol,but without the alcohol.One of the prominent ingredients in Alcarelle is GABA,a naturally occurring substance,that in humans,produces a calming effect that makes people feel more sociable through reducing feelings of anxiety,stress,and fear.As the ingredient becomes regulated and licensed to drink companies,consumers can expect to find new drinking solutions on shelf.The future of microdosing.AJNA BioSciencesWhile microdosing is sought out by consumers to help with mental health and as an alternative to alcohol,AJNA BioSciences is seeking to create a standardized psilocybin product and dosage,so that in the future,doctors can prescribe it to treat conditions like depression.With some ofthe benefits of microdosing including improved mood,focus,and creativity,consumers will have greater access to more natural,and legal products to make them feel good.Good Vices In MarketClear M&C Saatchi|Beyond Wellness 204045Opportunity#8Imagine ifIt was possible to personalize intoxicants to someones genetic makeup?Skincare regimens contained ingredients that replaced existing vices i.e.morning serum replaces your cup of coffee,evening moisturizer was your THC/CBD dose?There were medications that enabled super-quality sleep,so less hours were required for full recovery?Targeted supplements could modify organs e.g.,the liver to better process intoxicants?There was alcohol that didnt cause hangovers?Food&BeverageHealthcareBeauty&Personal CareClear M&C Saatchi|Beyond Wellness 2040What categories are most primed to disrupt or be disrupted by this opportunity?Good Vices46Opportunity#8Clear M&C Saatchi|Beyond Wellness 204047ExperiencingTransformationConsumers and businesses are considering how wellness can transform more than just a practice in their lives,or a product that they use it is becoming a way of life that has the power to lead to a renewed way of living and operating.It is a future state we predict to see embodied.9Secure Living10RenewalMetamorphosisInnovation Pathway#4Stats and Signals$4.94BProjected size of the global cryptocurrency market in 2030(USD)with a CAGR of 12.8%from 2021 to 2030.1Fear of crime most commonly constrains peoples mobility and possibly consumerism by preventing them from driving into certain areas of the town or city where they live-34%say they have ever avoided doing this.Relatedly,31%say they avoid visiting central areas of nearby cities.Only compounding the potential damper crime puts on economic activity,17%avoid going to shopping malls.2.2.6BBy 2050,the worlds population of people aged 60 years and older will double to 2.1 billion.The number of persons aged 80 years or older is expected to triple between 2020 and 2050 to reach 426 million.31.Allied Market Research,20212.Gallup,20233.World Health Organization,2022“A significant player in wellness is security.Unpredictable vulnerability and feeling out of control are two of the biggest threats to wellbeing.As such people are seeking safety nets and coping mechanisms for the lifequakes that affect their finances,aging,homing,health,and physical safety.Consumers are looking to the future with expectations that some things that had previously been unpredictable,will soon be predictable such as financial market fluctuations.The emergence of crypto showed the world there might be a way to avoid traditional market crashes.But it has its flaws and lacked an ability to get older generations onboard.Innovation is begging for a currency unaffected by market changes and a next-gen of cybersecurity to protect consumers greatest assets without risk of hacking or breaches.Alongside the strain of financial security is the need to address the prevalent anxiety in the US that aging as you want isnt a guarantee.With a governmental and societal system not set up to support our aging population,people fear life as an older person.The market is ripe for innovation to help people age gracefully without fear.People also want to feel more empowered around their health:both physical and mental.From their physical safety with the rise of products like Ring,to greater democratizing of healthcare with services like OnMed that uses AI for faster,accurate and predictive diagnoses that merge human and technology to better serve people.Consumers are expecting a future with a complete set of services to protect their whole life so they can feel secure through change.This is a massive and robust enemy to tackle in the wellness space.Secure LivingClear M&C Saatchi|Beyond Wellness 204048Opportunity#9From the fear of change losing financial stability,desirable housing,physical safety,and healthcare access,to lifestyle safeguards that instill trust and peace of mindThe future of crypto currency.Deutsche BoerseAs bitcoin breaks an all-time high in March 2024,far surpassing its previous all-time peak in November 2021,banks and governments are forced to pay attention to what the future of this currency will look like,and Deutsche Boerse is leading the charge.The capital market company has launched a regulated platform for the trading of crypto currencies for institutional investors.As crypto currencies becomes more mainstream and more nations consider it a legitimate currency for consumers to add and purchase with from a digital wallet,it gives consumers more options to diversify their assets and protect their wealth.Age confidently at home.Kendal at HomeTraditional retirement homes are of the past as aging populations seek out new ways to age at home with services like Kendal at Home.By empowering aging populations through services that help plan for aging,care coverage,and care management,Kendal at Home provides its consumers with the resources and tools needed to age safely and healthy at home.From specialists coordinating home plans with hospital beds to nutritional meals twice a day,Kendal at Home is there to support and help members make the choice to age at home and maintain their independence.Secure Living In MarketClear M&C Saatchi|Beyond Wellness 204049Opportunity#9Imagine ifThere was a form of currency that wasnt affected by market fluctuations?Connected homes could prevent falls and other emergencies by detecting sound and physical movements and intervening?Fully humanized AI robots could help older generations with daily tasks at home and keep them company(e.g.,cooking,cleaning,dressing,etc.)?Financial InstitutionsTechnology&HealthcareHome&HygieneClear M&C Saatchi|Beyond Wellness 2040Secure Living50Opportunity#9What categories are most primed to disrupt or be disrupted by this opportunity?The home could self-identify if any foreign viruses had entered and neutralize the threat to prevent infection?AI coaches could be hired to work on mental acuity to fend off diseases like Alzheimers?Stats and Signals$85BProjected size of the corporate wellness market in 2030(USD)with a CAGR of 4.8%from 2023 to 2030.1If you provide your employees with access to a comprehensive wellness program,you are communicating to them that you value their work,have faith in them,and want to see them succeed in their personal and professional lives.When employees are allowed to be creative,find solutions to issues,feel secure and valued,grow in self-esteem,and accomplish personal goals and objectives,their morale improves as a wholeresulting in happy,loyal employees.2.1.Fortune Business Insights,20232.Corestream,2022“The future will enable“wellness”brands to exist in all categories,setting a new precedent that will reconfigure the economy and challenge the status quo for what defines a wellness company.Well mostly see brands take one of two approaches to wellness:wellness as a part of their offering,or wellness as the umbrella over which their offering can exist.In the latter model,it is the ultimate mission of the brand.And consumers should understand as much.Wellness brands and experiences exist today no one is questioning that and it is a space primarily owned by health and beauty.But as the category continues to evolve,along with consumer understanding and dissection of the aspects of their lives that affects whether they are well,or not well,so will the kinds of companies that can pivot from having a wellness offering,to those that can be seen as a wellness brand.This will span workplaces where companies may have an existing identity,like a car manufacturer,but their ethos as a brand shifts towards wellness.From how their employees feel at work,to how their customers feel purchasing and then driving and experiencing the car.For example,by deciding to be a wellness brand that also sells cars,companies of all kinds can implement completely transformative business models and services that reinvent internal and external operations and perceptions.Its not a choice for all.And we dont recommend brands arbitrarily dip a toe in wellness and hope it sticks.Deciding how to enter and the way wellness fits into your brand is essential for authentically delivering it.From wellness as a singular part of a brand experience or approach,to wellness as the crux of it allClear M&C Saatchi|Beyond Wellness 204051Opportunity#10Renewal MetamorphosisThe wellbeing island.Joali BeingConsumers now more than ever are seeking out immersive and holistic experiences for both the body and mind and Joali Being,an island in the Maldives is delivering just that.With wellness programs that span Joali Beings four pillars;mind,skin,microbiome,and energy,travelers have a tailored 5-to-10-night stays curated to exactly what they need.From diet to exercise to therapy,consumers seeking a whole wellness experience can find it here.Happiness for all,in the drive.ToyotaWith many companies adopting wellness initiatives,Toyotas happiness for all program is set to put its people first.With a transformative plan to achieve a minimum 25male representation in the companys entry-level management to providing equal and fair opportunities and support sustainability initiatives,mobility is at the heart of Toyotas business.By improving wellness in the workplace,especially in Toyotas Woven City,Toyota is seeing impressive results in innovation and new thinking from workers,proving that wellness at work matters.Care for the planet and your people.PatagoniaWith employee satisfaction at the heart of the business,Patagonia empowers its employees with tuition reimbursement,on-site yoga and fitness,on-site child-care,and many other perks.Employees are excited to come to work knowing they have flexibility during the workday to pursue the hobbies they enjoy most,like surfing.With only a 4%turnover rate compared to the 27%national average,Patagonia retains their employees through programs that empower them to do better and feel better at work.Renewal Metamorphosis In MarketClear M&C Saatchi|Beyond Wellness 204052Opportunity#10Imagine ifWellness retreats and experiences were mandated yearly in the workplace?Credit cards helped you pay back your debt versus charging interest to help customers build wealth?Flying economy on any airline was not about getting from A to B in the most economical way,but was the REASON for a positive trip?The entire customer journey at a car company like Ford was focused on improving a drivers focus and anxiety to reduce accidents on the road?WorkplaceTravelFinancial InstitutionsClear M&C Saatchi|Beyond Wellness 2040Renewal Metamorphosis53Opportunity#10What categories are most primed to disrupt or be disrupted by this opportunity?Fortune 500s redesigned their brand strategy to focus on bringing greater wellness to their consumers and employees?Clear M&C Saatchi|Beyond Wellness 2040TREAT454TreatIdentify where you want to sit on the wellness spectrum.Deciding how you want wellness to show up in your brand is the first step in executing the right wellness strategy and deciding which opportunities will help you get there.Whether you want to embody it from head to toe,execute it as a spin-off of your core,or optimize your current portfolio with wellness principles,it is a personal choice and one determined by the current state of your business,your growth ambitions,and target consumer audiences.With the right strategic diagnosis,you can create a seamless pipeline for integrating wellness into your brand.Want to know more about connecting with the right mindset?Check out this thought piece we wrote diving into just this topic!Identify who youre serving,design for their needs.How wellness shows up in a persons life is deeply personal and unique.Your customers are different than your competitors,and different than the categories adjacent to you.If you want to double-down and service them with the right wellness experiences,products,or services,you must identify what needs are not being met and use wellness to unlock a new way to meet them.No matter how the world around us changes,customer centricity will always win.We recently covered this topic in more detail here.What your brand needs to do in the shorter-termFor the realized opportunities that need immediate ignitingClear M&C Saatchi|Beyond Wellness 204055TreatPrepare for a new-to-world diagnosis and work your way back from it.The wellness landscape is changing rapidly around us,and the next 15 years will only further accelerate the new ways we must think about how and where it shows up in our lives and in our brands.There will be new technology,new medicines,new beauty standards,new healthcare regulations all of which will need to be accounted for to strategize and re-strategize to get it right year after year.We expect disruption,but how you plan for it is what will future-proof your brand.Maintain a mindful gaze towards the unknown.Staying calm in the face of uncertainty and adapting to change is essential.Start small begin innovating for wellness in actionable ways and plan for the future without overcommitting to something that may not be there in 15 years.Take measured steps towards the big idea and start early.Want to hear more about our thoughts on building adaptive strategies,check out this article!What your brand needs to do in the longer-termFor the future possibilities that will change the breadth of wellnessClear M&C Saatchi|Beyond Wellness 204056Clear M&C Saatchi|Beyond Wellness 2040BE WELL557Be WellEmbrace the newness that the wellness category will always face,and the forces shaping the future.By focusing on near-in opportunities that can reposition your brand in the mind and hearts of consumers,and planning for long-term investments that drive transformation within your business and for your customers you will be well on your way to creating greater business and human impact.Be a first mover in being more well as a business.Clear M&C Saatchi|Beyond Wellness 204058ContactA bit about Clear M&C SaatchiWere a leading global growth strategy consultancy that clients trust to solve their most complex challenges.We believe that growth exists at the intersection of brand,experience,and innovation,and we believe in the power of clarity to unlock advantage for our clients.With a team of strategists and creatives based across three continents,weve generated growth for the worlds biggest brands across multiple industries and sectors.Clear is a division of M&C Saatchi plc(SAA:LSE),the worlds leading independent marketing services group.Lets strategize over lunch or a callFollow us on social for more tips and trendsAuthors:Amanda Payne,Associate Strategy DirectorJessica Taylor,ConsultantContributors:Rhonda Hiatt,Amanda Skudlarek,Claire Prather How we can help you prepare for the future of wellnessClear M&C Saatchi|Beyond Wellness 204059
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0 ACCESS TO ONCOLOGY COMBINATION THERAPIES IN EUROPE:MOVING FORWARD Medical Rationale Supporting Patient Access to Novel Oncology Combination Therapies March 2024 1 Contents 1.Introduction.2 2.Methodology.5 3.Combination therapies vs monotherapies:biological mechanisms.6 3.1.Current monotherapy oncology treatment approaches.6 3.2.Mechanistic advantages of combination therapies.7 4.Medical benefits of oncology combination therapies.9 5.Ongoing challenges for patient access:intervention is needed today.13 2 1.Introduction The cancer treatment landscape has undergone significant advances over recent decades.1,2 Although all-cancer incidence rates have increased in recent years3,overall cancer mortality rates in Europe have seen a decline.4 For instance,the European Society for Medical Oncology(ESMO)projected a 6crease in cancer mortality rates in men and a 4crease in cancer mortality rates in women in 2022,compared to mortality rates in 2017.5However,despite these advances,a high level of unmet need persists.In 2020,cancer was the second-leading cause of death in the EU,accounting for 23.0%of the total number of deaths in the EU.6 One reason for a high level of unmet need in some cancer patients is the susceptibility to drug resistance-related relapse during treatment with monotherapies and/or combinations containing chemotherapies.7,8,9 Considering this limitation,a new wave of novel oncology combination therapies(combination therapies composed of two or more innovative medicines used together)may be well-positioned to address these patients unmet needs.10,11 Given their unique benefits(such as a multi-pronged approach targeting different pathways and potential synergistic effects between the constituents),an increasing number of these novel combination therapies continue to enter the oncology pipeline and oncology treatment paradigms,and such therapies are providing significant medical benefits to patients.12 1 Danko,D.,Blay,J.Y.,&Garrison,L.P.(2019).Challenges in the value assessment,pricing and funding of targeted combination therapies in oncology.Health Policy,123(12),1230-1236.2 Briggs,Doyle,Schneider,Taylor,Roffe,Low,Davis,Kaiser,Hatswell,Rabin,Podkonjak.An Attribution of Value Framework for Combination Therapies.(January 2021)3 Ferlay J,Colombet M and Bray F.Cancer Incidence in Five Continents,CI5plus:IARC CancerBase No.9 Internet.Lyon,France:International Agency for Research on Cancer;2018.Available from:http:/ci5.iarc.fr.4 Dalmartello M;La Vecchia C;Bertuccio P;Boffetta P;Levi F;Negri E;Malvezzi M;European cancer mortality predictions for the year 2022 with focus on ovarian cancer Internet.U.S.National Library of Medicine;cited 2023 Jul 26.Available from:https:/pubmed.ncbi.nlm.nih.gov/35090748/5 European Society for Medical Oncology(ESMO).(2022)Death Rates from Ovarian Cancer will Fall in the EU and UK in 2022 Annals of Oncology Press Release.Accessed 28th July 2023.Available at:https:/www.esmo.org/newsroom/press-releases/death-rates-from-ovarian-cancer-will-fall-in-the-eu-and-uk-in-2022 6 European Comission:Eurostat Cancer Statistics Internet.cited 2023 Jul 24.Available from:https:/ec.europa.eu/eurostat/statistics-explained/index.php?title=Cancer_statistics#:text=healthcare and equipment-,Deaths from cancer,among women (20.0 %).7 Khdair A,Chen D,Patil Y,Ma L,Dou QP,Shekhar MP,Panyam J.Nanoparticle-mediated combination chemotherapy and photodynamic therapy overcomes tumor drug resistance.J Control Release.2010;141:137-44.8 Gottesman MM,Fojo T,Bates SE.Multidrug resistance in cancer:role of ATP-dependent transporters.Nat Rev Cancer.2002;2:48-58.9 Jardim DL,De Melo Gagliato D,Nikanjam M,Barkauskas DA,Kurzrock R.Efficacy and safety of anticancer drug combinations:a meta-analysis of randomized trials with a focus on immunotherapeutics and gene-targeted compounds.Oncoimmunology.2020 Jan 1;9(1):1710052.10 Mokhtari,R.B.,Homayouni,T.S.,Baluch,N.,Morgatskaya,E.,Kumar,S.,Das,B.and Yeger,H.,2017.Combination therapy in combating cancer.Oncotarget,8(23),p.38022.11 Boshuizen,J.and Peeper,D.S.(2020)“Rational cancer treatment combinations:An urgent clinical need,”Molecular Cell,78(6),pp.10021018.12 Mokhtari,R.B.,Homayouni,T.S.,Baluch,N.,Morgatskaya,E.,Kumar,S.,Das,B.and Yeger,H.,2017.Combination therapy in combating cancer.Oncotarget,8(23),p.38022.3 Between 2015 and 2022,approximately 35 novel combination therapies were approved in Europe.13 These therapies have typically targeted major tumour types such as breast cancer,non-small-cell lung cancer(NSCLC)and colorectal cancer.14 Given their unique therapeutic potential,many novel oncology combination therapies are expected to launch during the coming years,with 77 phase 2 and 3 trials planned(i.e.,active,currently recruiting,or not yet recruiting)for oncology combination therapies,as of August 2022.15 However,despite providing significant medical benefits to patients,novel oncology combination therapies continue to face challenges associated with patient access due to value assessment and pricing and reimbursement complexities.16,17,18,19,20 Although multiple stakeholder groups have debated such access challenges,there is still limited awareness about the issues,and access to novel oncology combinations has lagged behind access to oncology medicines in general.21 This lack of awareness is partly due to the complexity of the topic,the tendency to associate novel oncology combinations with combinations containing only one innovative constituent,and the misperception of the value they can deliver.To incentivise the development of feasible and impactful solutions to ensure patient access to novel oncology combination therapies,it is essential to consider and acknowledge such treatments benefits.To provide an overview of these benefits,the EFPIA Oncology Platform(EOP)commissioned this consensus document(Box 1).This document describes the mechanistic advantages of oncology combination therapies and highlights the medical benefits of oncology combination therapies that cannot be delivered by monotherapies.Several examples of effective oncology combination therapies have also been presented to demonstrate the clinical benefits provided to patients.13 CRA analysis(June 2023)14 Jardim DL,De Melo Gagliato D,Nikanjam M,Barkauskas DA,Kurzrock R.Efficacy and safety of anticancer drug combinations:a meta-analysis of randomized trials with a focus on immunotherapeutics and gene-targeted compounds.Oncoimmunology.2020 Jan 1;9(1):1710052.15 CRA analysis,August 2022 16 Danko,D.,Blay,J.Y.,&Garrison,L.P.(2019).Challenges in the value assessment,pricing and funding of targeted combination therapies in oncology.Health Policy,123(12),1230-1236.17 Briggs,Doyle,Schneider,Taylor,Roffe,Low,Davis,Kaiser,Hatswell,Rabin,Podkonjak.An Attribution of Value Framework for Combination Therapies.(January 2021)18 OECD.Addressing the challenges in access to oncology medicines.(2020)19 Latimer N,Pollard D,Towse A,Henshall C.Challenges in valuing and paying for combination regimens in oncology.Report of an international workshop convened by Bellberry,held on November 18-20,in Sydney,Australia.(May 2020)20 Danko,D.,Blay,J.Y.,&Garrison,L.P.(2019).Challenges in the value assessment,pricing and funding of targeted combination therapies in oncology.Health Policy,123(12),1230-1236.21 Latimer N,Pollard D,Towse A,Henshall C.Challenges in valuing and paying for combination regimens in oncology.Report of an international workshop convened by Bellberry,held on November 18-20,in Sydney,Australia.(May 2020)4 Box 1:The overall purpose and intended audience of this report Purpose and scope of this report The document aims to summarise the mechanistic advantages of combination therapies and their medical benefits for patients.This report is primarily intended for policymakers to incentivise the development and introduction of impactful solutions to improve patient access.Specific challenges for patient access to novel oncology combination therapies will be briefly covered,but this will not be a key focus of this consensus document;the EFPIA Oncology Platform has reported on such challenges extensively in previous work developed in 2022.5 2.Methodology The methodology used to develop this consensus document was designed to obtain a comprehensive understanding of oncology combination therapies:a three-step approach was adopted to inform this analysis.Firstly,a brief literature review was undertaken to identify the most recent peer-reviewed articles on the benefits of oncology combination therapies.The literature review focused primarily on recent publications on combination therapies(published in the last six years,2017-2022);some earlier-dated publications(2002-2014)were also reviewed to provide insights on the unmet need that could not be satisfied with monotherapies.Articles were identified by researching keywords(such as:“oncology combinations”,“medical benefits”,“immunotherapy combination”,and“clinical trial oncology combinations”)through Google,Google Scholar,PubMed,and selected websites.A total of 28 papers were selected for review including academic journals,clinical trial reports and articles.Where necessary,additional analyses were performed to gain further insights into the clinical benefits of combination therapies.The findings from the literature review were consolidated to form a draft consensus document.Secondly,medical experts from eight member companies of the EOPs combination therapies working group were interviewed between April and July 2023 to validate the findings of the draft consensus document and provide additional guidance.Finally,interviews with six leading non-industry experts were held to review the consensus document,gain additional insights,and finalise the report.These experts included a variety of stakeholders,such as medical oncologists,policymakers,health economists and patient advocacy group representatives.6 3.Combination therapies vs monotherapies:biological mechanisms 3.1.Current monotherapy oncology treatment approaches Although chemotherapy has been the mainstay of cancer treatments for decades,these treatments have shown limitations in efficacy.For example,chemotherapies have not demonstrated the ability to eliminate cancer stem cells,due to their fewer specific mechanisms of action.Consequently,neoplasms remain capable of self-renewing,de-differentiating,and becoming metastatic(having the potential to invade/spread to other body tissues)due to their high mutation rates.22 Over recent decades,there has been a shift in cancer treatment paradigms towards more targeted therapies,such as tyrosine kinase inhibitors,and more personalised therapies,such as immunotherapies.Immunotherapies,although targeting the immune system non-specifically,can augment the response of the bodys natural immune system,leading to a more targeted immune response against the tumour.23 However,despite these treatments providing improvements in efficacy compared to chemotherapies,limitations still exist for some patients including susceptibility to drug resistance.The heterogeneous nature of cancer means that some cancer cells can evade the anti-cancer effects of treatment.These cells are induced to utilise alternative signalling pathways to evade the immune system,avoiding the anti-cancer effects of the monotherapy and forming drug resistance.24,25 They are described as therapy-induced resistant cancer cells(or cancer stem cells)and can multiply and drive the growth of the tumour(Figure 1).26 22 Chen K,Huang YH,Chen JL.Understanding and targeting cancer stem cells:therapeutic implications and challenges.Acta Pharmacol Sin.2013;34:732-40.23 Akkn S,Varan G,Bilensoy E.A review on cancer immunotherapy and applications of nanotechnology to chemoimmunotherapy of different cancers.Molecules.2021 Jun 3;26(11):3382.24 Khdair A,Chen D,Patil Y,Ma L,Dou QP,Shekhar MP,Panyam J.Nanoparticle-mediated combination chemotherapy and photodynamic therapy overcomes tumor drug resistance.J Control Release.2010;141:137-44.25 Jardim DL,De Melo Gagliato D,Nikanjam M,Barkauskas DA,Kurzrock R.Efficacy and safety of anticancer drug combinations:a meta-analysis of randomized trials with a focus on immunotherapeutics and gene-targeted compounds.Oncoimmunology.2020 Jan 1;9(1):1710052.26 National Cancer Institute(2016)Why Do Cancer Treatments Stop Working?Overcoming Treatment Resistance.Available at:https:/www.cancer.gov/about-cancer/treatment/research/drug-combo-resistance(Accessed:April 15,2023).7 Figure 1 Treatment-induced drug resistance in cancer cells.As the tumour responds to treatment,some cancer cells will be capable of utilising alternative signalling pathways to avoid destruction by the treatment.Subsequently,these cells will proliferate and contribute to the re-growth of the tumour.27 Source:National Cancer Institute(2016)Why Do Cancer Treatments Stop Working?Overcoming Treatment Resistance.Available at:https:/www.cancer.gov/about-cancer/treatment/research/drug-combo-resistance(Accessed:April 15,2023)Patient susceptibility to drug resistance associated with monotherapy treatment is demonstrated by studies showing that some patients who initially respond to immunotherapy treatment can experience drug-resistant relapse within months or years.28 Therefore,there is a clear medical need to enhance the effectiveness of current constituents via alternative treatment strategies such as combining novel constituents,to provide more robust and durable responses against the tumour.3.2.Mechanistic advantages of combination therapies Combination therapies often demonstrate superior clinical benefits for some cancer patients compared to monotherapies.34,35,29 Such superior efficacy is underpinned by the mechanistic benefits of combination therapies that monotherapies lack,such as their ability to target multiple signalling pathways simultaneously.58 Essentially,our understanding of cancer biology is growing,and this is allowing more efficacious therapies to be developed.For example,certain constituents may act to prime the tumour microenvironment,allowing the 27 National Cancer Institute(2016)Why Do Cancer Treatments Stop Working?Overcoming Treatment Resistance.Available at:https:/www.cancer.gov/about-cancer/treatment/research/drug-combo-resistance(Accessed:April 15,2023).28 Syn,N.L.;Teng,M.W.L.;Mok,T.S.K.;Soo,R.A.De-novo and acquired resistance to immune checkpoint targeting.Lancet Oncol.2017,18,e731e741.29 Briggs,Doyle,Schneider,Taylor,Roffe,Low,Davis,Kaiser,Hatswell,Rabin,Podkonjak.An Attribution of Value Framework for Combination Therapies.(January 2021)8 other constituent within the combination therapy to exert a more efficacious anti-cancer effect.30 Compared to monotherapies,combination therapies generally reduce the probability of the tumour developing drug resistance.This results from the cancer cells not adapting rapidly enough to utilise alternative signalling pathways to evade being targeted by the combination therapy.31 For example,combination therapies that contain constituents targeting cancer stem cells have been shown to reduce the risk of relapse compared to monotherapies.32 The constituents of combination therapies may also work synergistically(i.e.,exerting a greater therapeutic effect than the sum of their individual effects,possibly by targeting multiple signalling pathways)to enhance the anti-cancer effects of each medicine(i.e.,CTLA-4 and PD-1 combination blockade has been proven to enhance natural immune responses and improve patient response rates).33,34 Not only does this mechanism contribute to improved efficacy of the treatments versus monotherapies,but the individual constituents are often administered in smaller dosages,possibly reducing toxicity and limiting the dosing burden for patients.35,36 Overall,novel oncology combination therapies possess clear mechanistic,biological benefits over monotherapies that translate to improved medical outcomes for some cancer patients.30 Chyuan IT,Chu CL,Hsu PN.Targeting the Tumor Microenvironment for Improving Therapeutic Effectiveness in Cancer Immunotherapy:Focusing on Immune Checkpoint Inhibitors and CombinationTherapies.Cancers(Basel).2021;13(6).31 Zimmermann GR,Lehar J,Keith CT.Multi-target therapeutics:when the whole is greater than the sum of the parts.Drug Discov Today.2007;12:34-42.32 Takebe N,Miele L,Harris PJ,Jeong W,Bando H,Kahn M,Yang SX,Ivy SP.Targeting Notch,Hedgehog,and Wnt pathways in cancer stem cells:clinical update.Nat Rev Clin Oncol.2015;12:445-64.33 Hellmann,M.D.,Paz-Ares,L.,Bernabe Caro,R.,Zurawski,B.,Kim,S.-W.,Car-cereny Costa,E.,Park,K.,Alexandru,A.,Lupinacci,L.,de la Mora Jimenez,E.,et al.(2019).Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer.N.Engl.J.Med.381,20202031.34 Gide,T.N.,Quek,C.,Menzies,A.M.,Tasker,A.T.,Shang,P.,Holst,J.,Madore,J.,Lim,S.Y.,Velickovic,R.,Wongchenko,M.,et al.(2019).Distinct Immune Cell Populations Define Response to Anti-PD-1 Monotherapy and Anti-PD-1/Anti-CTLA-4 Combined Therapy.Cancer Cell 35,238255.e6.35 Albain KS,Nag SM,Calderillo-Ruiz G,Jordaan JP,Llombart AC,Pluzanska A,Rolski J,Melemed AS,Reyes-Vidal JM,Sekhon JS,Simms L,OShaughnessy J.Gemcitabine plus Paclitaxel versus Paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment.J Clin Oncol.2008;26:3950-7.36 Mokhtari RB,Kumar S,Islam SS,Yazdanpanah M,Adeli K,Cutz E,Yeger H.Combination of carbonic anhydrase inhibitor,acetazolamide,and sulforaphane,reduces the viability and growth of bronchial carcinoid cell lines.BMC Cancer.2013;13:378.9 4.Medical benefits of oncology combination therapies Importantly,the mechanistic advantages of oncology combination therapies underpin medical benefits for some cancer patients including improved clinical efficacy compared to monotherapies and an increased likelihood of the patients overcoming drug resistance,thereby extending the duration of the anti-cancer effects.37,38,39,40,41 In terms of improved clinical efficacy,a meta-analysis of 95 clinical trials of combination therapies completed between 2001-2018 showed that novel oncology combination therapies of non-chemotherapeutic(e.g.,small molecules,immunotherapies and/or hormonal therapies)medicines provide statistically significant improvements in median overall survival(OS),progression-free survival(PFS)and overall response rate(ORR)compared to non-chemotherapeutic monotherapies.42 Clinical trials comparing combination therapies versus the current standard of care have also demonstrated compelling medical benefits for cancer patients.For example,a triple-novel combination(a combination therapy containing three novel constituents)of encorafenib,binimetinib and cetuximab has shown significant improvements in OS and ORR in colorectal cancer.The doublet combination of encorafenib and cetuximab also demonstrated clinical superiority over cetuximab plus generic chemotherapy.43,44 These findings demonstrate how novel combination therapies can provide anti-cancer effects,superior to that of monotherapies,to achieve positive clinical responses.Additionally,a combination of monoclonal antibodies,nivolumab and ipilimumab,has demonstrated strong superiority in median OS and treatment-free survival,in patients with advanced melanoma,over both constituents as monotherapies.45 The nivolumab and ipilimumab also showed superior OS achieved over both constituents as monotherapies after 37 Kopetz S,Grothey A,Yaeger R,Van Cutsem E,Desai J,Yoshino T,Wasan H,Ciardiello F,Loupakis F,Hong YS,Steeghs N.Encorafenib,binimetinib,and cetuximab in BRAF V600Emutated colorectal cancer.New England Journal of Medicine.2019 Oct 24;381(17):1632-43.38 Wolchok JD,Chiarion-Sileni V,Gonzalez R,et al.Long-term outcomes with nivolumab plus ipilimumab or nivolumab alone versus ipilimumab in patients with advanced melanoma.J Clin Oncol.2022;40(2):127-137.doi:10.1200/JCO.21.02229 39 Janjigian YY,Kawazoe A,Yanez PE,Luo S,Lonardi S,Kolesnik O,Barajas O,Bai Y,Shen L,Tang Y,Wyrwicz L.Pembrolizumab plus trastuzumab and chemotherapy for HER2 metastatic gastric or gastroesophageal junction(G/GEJ)cancer:Initial findings of the global Phase 3 KEYNOTE-811 study.40 ClinicalTrials.gov(2023)NCT03615326.Available at:https:/clinicaltrials.gov/ct2/show/record/NCT03615326(Accessed:April 12,2023).41 Larkin J,Ascierto PA,Drno B,Atkinson V,Liszkay G,Maio M,Mandal M,Demidov L,Stroyakovskiy D,Thomas L,de la Cruz-Merino L,Dutriaux C,Garbe C,Sovak MA,Chang I,Choong N,Hack SP,McArthur GA,Ribas A.Combined vemurafenib and cobimetinib in BRAF-mutated melanoma.N Engl J Med.2014 Nov 13;371(20):1867-76.doi:10.1056/NEJMoa1408868 42 Jardim DL,De Melo Gagliato D,Nikanjam M,Barkauskas DA,Kurzrock R.Efficacy and safety of anticancer drug combinations:a meta-analysis of randomized trials with a focus on immunotherapeutics and gene-targeted compounds.Oncoimmunology.2020 Jan 1;9(1):1710052.43 Kopetz S,Grothey A,Yaeger R,Van Cutsem E,Desai J,Yoshino T,Wasan H,Ciardiello F,Loupakis F,Hong YS,Steeghs N.Encorafenib,binimetinib,and cetuximab in BRAF V600Emutated colorectal cancer.New England Journal of Medicine.2019 Oct 24;381(17):1632-43.44 Kopetz S,Grothey A,Yaeger R,Van Cutsem E,Desai J,Yoshino T,Wasan H,Ciardiello F,Loupakis F,Hong YS,Steeghs N.Encorafenib,binimetinib,and cetuximab in BRAF V600Emutated colorectal cancer.New England Journal of Medicine.2019 Oct 24;381(17):1632-43.45 Wolchok JD,Chiarion-Sileni V,Gonzalez R,et al.Long-term outcomes with nivolumab plus ipilimumab or nivolumab alone versus ipilimumab in patients with advanced melanoma.J Clin Oncol.2022;40(2):127-137.doi:10.1200/JCO.21.02229 10 a minimum of 77 months follow-up period.46 Further examples of the strong clinical superiority of novel combination therapies are provided in Box 2.Box 2:Novel combination therapies with superior efficacy over alternative standard-of-care therapies Examples of double/triple-novel combination therapies with superior efficacy over standard of care Dabrafenib and trametinib A phase 3 trial was performed including 423 previously untreated patients with unresectable stage III or stage IV melanoma with a BRAF V600E or V600K mutation receiving a combination of dabrafenib and trametinib,or dabrafenib and placebo.47 This was one of the first studies highlighting the superior efficacy of a novel oncology combination therapy(dabrafenib and trametinib)over dabrafenib or trametinib monotherapies.At 6 months,the interim overall survival rate was 93%within the combination group and 85%within the dabrafenib-only group.The combination group also demonstrated a lower rate of cutaneous squamous-cell carcinoma,a known and challenging toxicity of monotherapy BRAF inhibition,(2%vs 9%)compared with the dabrafenib plus placebo group.Nivolumab and ipilimumab Nivolumab and ipilimumab are currently approved in combination for the treatment of six different tumour types.48 In a phase III trial,this combination therapy demonstrated durable,improved clinical outcomes versus either constituent as a monotherapy for patients with advanced melanoma.49 Specifically,nivolumab and ipilimumab provided a 51%greater median OS(72.1 vs 36.9 months)to patients compared to nivolumab alone,and a 72%greater median OS(72.1 vs 19.9 months)compared to ipilimumab alone.The combination also showed strong superiority in treatment-free survival over both monotherapies;in patients who discontinued treatment,the median treatment-free interval was 27.6,2.3,and 1.9 months for the combination,nivolumab alone and ipilimumab alone,respectively.50 46 Wolchok JD,Chiarion-Sileni V,Gonzalez R,et al.Long-term outcomes with nivolumab plus ipilimumab or nivolumab alone versus ipilimumab in patients with advanced melanoma.J Clin Oncol.2022;40(2):127-137.doi:10.1200/JCO.21.02229 47 Long GV,Stroyakovskiy D,Gogas H,Levchenko E,de Braud F,Larkin J,et al.Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma.New England Journal of Medicine.2014;371(20):187788.doi:10.1056/nejmoa1406037 48 EMA(2023)Opdivo,European Medicines Agency.Available at:https:/www.ema.europa.eu/en/medicines/human/EPAR/opdivoda(Accessed:April 15,2023).49 Wolchok JD,Chiarion-Sileni V,Gonzalez R,et al.Long-term outcomes with nivolumab plus ipilimumab or nivolumab alone versus ipilimumab in patients with advanced melanoma.J Clin Oncol.2022;40(2):127-137.doi:10.1200/JCO.21.02229 50 Wolchok JD,Chiarion-Sileni V,Gonzalez R,et al.Long-term outcomes with nivolumab plus ipilimumab or nivolumab alone versus ipilimumab in patients with advanced melanoma.J Clin Oncol.2022;40(2):127-137.doi:10.1200/JCO.21.02229 11 Lenvatinib plus pembrolizumab or everolimus A phase 3 trial was performed including 1069 patients with advanced renal cell carcinoma and no previous systemic therapy.Patients received lenvatinib plus pembrolizumab,lenvatinib plus everolimus,or sunitinib alone.51 This study highlighted the superior efficacy of the novel combination therapy(lenvatinib plus pembrolizumab)over lenvatinib plus everolimus or sunitinib monotherapy.The lenvatinib plus pembrolizumab achieved a longer PFS of 23.9 vs.14.7 vs 9.2 months compared to lenvatinib plus everolimus and sunitinib monotherapy.40%of the patients in the lenvatinib plus pembrolizumab group also reached median OS,compared to 31.4%and 18.8%of patients in the lenvatinib plus everolimus group,or the sunitinib-alone group respectively.Encorafenib,binimetinib and cetuximab An open-label,phase 3 trial was performed including 665 patients with BRAF V600Emutated metastatic colorectal cancer who had had disease progression after one or two previous regimens.52 This study highlighted the superior efficacy of a triple-novel therapy(encorafenib,binimetinib,cetuximab)over the standard of care(cetuximab plus generic chemotherapy).The triple-novel combination therapy provided a 37%increase in OS(9.0 months vs 5.4 months)versus standard of care and achieved significantly higher overall response rates in patients versus standard of care(26%vs 2%).53 Vemurafenib and cobimetinib Vemurafenib and cobimetinib are currently approved in combination for the treatment of unresectable or metastatic melanoma with a BRAF V600 mutation.54 In a phase 3 study of 495 patients,the combination therapy demonstrated strong clinical superiority over vemurafenib as a monotherapy;providing a 60%increase in median PFS(9.9 vs 6.2 months)and a greater complete/partial response(68%vs 45%)against the monotherapy.Additionally,patients receiving the combination therapy did not experience a significantly higher incidence of grade 3 and above adverse events compared with the monotherapy 51 Motzer R,Alekseev B,Rha SY,Porta C,Eto M,Powles T,Grnwald V,Hutson TE,Kopyltsov E,Mndez-Vidal MJ,Kozlov V,Alyasova A,Hong SH,Kapoor A,Alonso Gordoa T,Merchan JR,Winquist E,Maroto P,Goh JC,Kim M,Gurney H,Patel V,Peer A,Procopio G,Takagi T,Melichar B,Rolland F,De Giorgi U,Wong S,Bedke J,Schmidinger M,Dutcus CE,Smith AD,Dutta L,Mody K,Perini RF,Xing D,Choueiri TK;CLEAR Trial Investigators.Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma.N Engl J Med.2021 Apr 8;384(14):1289-1300.doi:10.1056/NEJMoa2035716.Epub 2021 Feb 13.PMID:33616314.52 Kopetz S,Grothey A,Yaeger R,Van Cutsem E,Desai J,Yoshino T,Wasan H,Ciardiello F,Loupakis F,Hong YS,Steeghs N.Encorafenib,binimetinib,and cetuximab in BRAF V600Emutated colorectal cancer.New England Journal of Medicine.2019 Oct 24;381(17):1632-43.53 Kopetz S,Grothey A,Yaeger R,Van Cutsem E,Desai J,Yoshino T,Wasan H,Ciardiello F,Loupakis F,Hong YS,Steeghs N.Encorafenib,binimetinib,and cetuximab in BRAF V600Emutated colorectal cancer.New England Journal of Medicine.2019 Oct 24;381(17):1632-43.54 EMA(2023)Cotellic,European Medicines Agency.Available at:https:/www.ema.europa.eu/en/medicines/human/EPAR/cotellic(Accessed:April 15,2023).12 group(65%vs.59%),and the number of secondary cutaneous cancers decreased with the combination therapy.55 Pembrolizumab and trastuzumab Pembrolizumab has entered many various combination therapies in oncology and is approved by the EMA for the treatment of eleven different tumour types.56 Currently,pembrolizumab is being evaluated in combination with trastuzumab and generic chemotherapies,versus trastuzumab and generic chemotherapy alone,for the treatment of HER2 metastatic gastric or gastroesophageal junction(G/GEJ)cancer.57 Initial trial results(estimated n=732)have shown the addition of pembrolizumab to(trastuzumab plus generic chemotherapies)to provide a substantial,statistically significant increase in overall response rate(ORR)(74%vs 52%).58 It should be noted that meta-analyses have shown that some combination therapies may increase rates of adverse events.However,the rate of adverse events and levels of toxicity associated with the combination therapies did not show a linear increase(i.e.,the rates of rate of adverse events and toxicity did not double in patients treated with combination therapies compared to those treated with monotherapies)and it was concluded that the increased safety risk was outweighed by the strong clinical efficacy benefits provided by the combinations.59 55 Larkin J,Ascierto PA,Drno B,Atkinson V,Liszkay G,Maio M,Mandal M,Demidov L,Stroyakovskiy D,Thomas L,de la Cruz-Merino L,Dutriaux C,Garbe C,Sovak MA,Chang I,Choong N,Hack SP,McArthur GA,Ribas A.Combined vemurafenib and cobimetinib in BRAF-mutated melanoma.N Engl J Med.2014 Nov 13;371(20):1867-76.doi:10.1056/NEJMoa1408868 56 EMA(2023)Keytruda,European Medicines Agency.Available at:https:/www.ema.europa.eu/en/medicines/human/EPAR/keytruda(Accessed:April 12,2023).57 ClinicalTrials.gov(2023)NCT03615326.Available at:https:/clinicaltrials.gov/ct2/show/record/NCT03615326(Accessed:April 12,2023).58 Janjigian YY,Kawazoe A,Yanez PE,Luo S,Lonardi S,Kolesnik O,Barajas O,Bai Y,Shen L,Tang Y,Wyrwicz L.Pembrolizumab plus trastuzumab and chemotherapy for HER2 metastatic gastric or gastroesophageal junction(G/GEJ)cancer:Initial findings of the global Phase 3 KEYNOTE-811 study.59 Jardim DL,De Melo Gagliato D,Nikanjam M,Barkauskas DA,Kurzrock R.Efficacy and safety of anticancer drug combinations:a meta-analysis of randomized trials with a focus on immunotherapeutics and gene-targeted compounds.Oncoimmunology.2020 Jan 1;9(1):1710052.13 5.Ongoing challenges for patient access:intervention is needed today Novel oncology combination therapies are providing clear medical benefits to many patients,underpinned by biological and mechanistic advantages over alternative monotherapies.Given the large number of combinations expected to launch in the coming years,Error!Reference source not found.60 it is likely that such therapies will continue to advance the standards of cancer care.However,alongside this promising outlook,there are significant access challenges that must be addressed to ensure patient availability of these highly effective therapies.61,62,71 One major challenge lies in the current health technology assessment(HTA)frameworks that generally do not have specific approaches for evaluating combination therapies.63 Therefore,it is challenging to determine the proportional value that each constituent brings to the combination therapy and consequently,the manufacturer of the last constituent to the market is called to demonstrate the value for money of the whole combination but would only be able to leverage the price of the last constituent as a negotiation tool.For instance,in cost-effectiveness-focused markets(e.g.,the UK),some combinations may not be cost-effective even if the second therapy is priced at zero,as the first(backbone)constituent may already be reimbursed near the willingness to pay threshold of the payer,leaving little headroom to pay for the second(add-on)constituent.64 Complexities for pricing negotiation and concerns with competition laws also pose challenges for combination therapies.Current pricing frameworks often discourage the participation of some manufacturers.For the price of the combination therapy to be aligned with the combinations value from the payers perspective,a price reduction for the first constituent may be required.71 However,if the constituents are owned by different manufacturers,the manufacturer of the first constituent may not be able to provide further price reductions,especially if the first constituent is already marketed for other indications.Manufacturers are also hesitant to discuss access strategies due to concerns about infringing competition law,often leaving the manufacturer of the add-on therapy solely responsible for negotiating reimbursement for the combination with no knowledge of the backbone therapys economic or clinical data.Additional barriers to access further complicate the situation.The lack of adequate payment mechanisms limits manufacturers ability to negotiate access effectively.70,71 There is limited use of novel payment mechanisms,such as specific prices for use in combinations,which could help address access challenges without affecting the backbone constituents price in 60 CRA analysis,August 2022 61 OECD.Addressing the challenges in access to oncology medicines.(2020)62 Latimer N,Pollard D,Towse A,Henshall C.Challenges in valuing and paying for combination regimens in oncology.Report of an international workshop convened by Bellberry,held on November 18-20,in Sydney,Australia.(May 2020)63 Danko,D.,Blay,J.Y.,&Garrison,L.P.(2019).Challenges in the value assessment,pricing and funding of targeted combination therapies in oncology.Health Policy,123(12),1230-1236.64 Latimer NR,Towse A,Henshall C.Not cost-effective at zero price:valuing and paying for combination therapies in cancer.Expert Review of Pharmacoeconomics&Outcomes Research.2021 May 4;21(3):331-3.14 other indications.Furthermore,the ability to track therapy usage in combinations versus monotherapies is essential for implementing novel pricing models,such as combination-specific pricing.However,an absence of usage-tracking infrastructure in many European countries also restricts the potential implementation of access solutions.Although multiple stakeholder groups have debated the problem and the potential solutions,there is still limited awareness about the challenges to patient access and progress has been slow in trying to solve it in practice.If no policy interventions are undertaken,the limitations on treatment availability and consequences for patients are expected to worsen as an increasing number of combinations are in development and aim to launch over the coming years.Furthermore,manufacturers may be disincentivised to invest in the development of combination therapies,limiting the potential of future research.Considering these challenges,it is crucial for stakeholders,including policymakers,payers,and pharmaceutical companies,to collaboratively develop innovative and adaptive solutions.Addressing the reimbursement,pricing,and competition law concerns surrounding novel oncology combination therapies will be key to ensuring that patients can readily access these highly effective treatments,leading to improved cancer outcomes and better quality of life for patients.
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www.isaps.orgISAPS INTERNATIONAL SURVEY ONAESTHETIC/COSMETICPROCEDURESperformed in2023CONTENTSAbout ISAPS.page 3About the International Survey onAesthetic/Cosmetic Procedures.page 4HIGHLIGHTS OF THE 2023 STATISTICS2023 Statistics at a Glance.pages 6-7NUMBER OF WORLDWIDE PROCEDURES Worldwide Surgical Procedures.page 9Worldwide Non-Surgical Procedures.page 10Surgical Procedures by Region of the Body.page 11Non-Surgical Procedures by Type of Procedure.page 12Overview of All Procedures.page 13PROCEDURES BY COUNTRYUS.page 15Brazil.page 16Mexico.page 17Germany.page 18Argentina.page 19Turkiye.page 20India.page 21France.page 22Italy.page 23Spain.page 24Colombia.page 25Peru.page 26Iran.page 27Venezuela.page 28Romania.page 29UK.page 30Belgium.page 31Greece.page 32Thailand.page 33Syria.page 34South Africa.page 35Malaysia.page 36Bangladesh.page 37Surgical Procedures by Country.pages 38-39Non-Surgical Procedures by Country.pages 40-41Total Procedures(All)by Country.pages 40-41 Countries Performing the Most Popular Surgical Procedures.page 42Countries Performing the Most Popular Non-Surgical Procedures.page 43Surgical Totals Ranked by Category.page 44Non-Surgical Totals Ranked by Category.page 45Countries Ranked by Total Number of Procedures.page 46Countries Ranked by Estimated Number of Plastic Surgeons.page 47Surgical Procedure Group Ranking by Country.page 48Non-Surgical Procedure Group Ranking by Country.page 49PROCEDURES PERFORMED BY PLASTIC SURGEONS Number of Worldwide Surgical Procedures Performed by Plastic Surgeons.page 51Number of Worldwide Non-Surgical Procedures Performed by Plastic Surgeons.page 52Percentage of Plastic Surgeons Performing Each Surgical Procedure.pages 53-56Percentage of Plastic Surgeons Performing Each Non-Surgical Procedure.pages 57-58DEMOGRAPHICS Gender Distribution for Cosmetic Procedures Surgical.page 60Gender Distribution for Cosmetic Procedures Non-Surgical.page 61 Patient Age Related to Cosmetic Procedures.page 62 Cosmetic Procedures by Location.page 63Medical Tourism.page 64RESIDENT&ADDITIONAL STATISTICSResident Statistics.pages 66-67Additional Statistics.pages 68-69INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 3 ABOUT ISAPSFounded in 1970,the International Society of Aesthetic Plastic Surgery(ISAPS)is the worlds leading professional body for board-certified aesthetic plastic surgeons.Regarded as the leading global authority on aesthetic and cosmetic surgery,ISAPS threefold mission is to offer Aesthetic Education Worldwide,to provide accurate information to the public,and to promote patient safety.ISAPS membership includes the worlds best and most respected reconstructive and aesthetic plastic surgeons in over 117 countries.Through its rigorous membership requirements,ISAPS plastic surgeons are considered to be among the most qualified surgeons in their respective countries.Furthermore,ISAPS has become the gold standard for providing continuing aesthetic education to its members,providing training,and sponsoring scientific meetings around the world.A full list of ISAPS plastic surgeons can be found online at www.isaps.org.INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 4 2024 ISAPS INTERNATIONAL SURVEY ON AESTHETIC/COSMETICPROCEDURES PERFORMED IN 2023METHODOLOGYSurvey participants completed a questionnaire that primarily focused on the number of specific surgical and non-surgical procedures performed in 2023,along with some ancillary questions related to surgeon demographics and the prevalence of medical tourism.The International Society of Aesthetic Plastic Surgery(ISAPS)issued an invitation to participate in the study to approximately 25,000 plastic surgeons whose contact information is housed in its proprietary database.In addition,a request was made that all National Societies encourage their members/constituents to take part in the survey.Data from more than 1,600 plastic surgeons were compiled for this survey.Final figures have been projected to reflect international statistics and are exclusively based on the estimated number of plastic surgeons actively practicing in each country and the respondent sample.This international survey is focused on physicians who are board-certified(or national equivalent)plastic surgeons.To aid in tallying the worldwide estimate of plastic surgeons,representatives from National Societies provided recent counts for 96%of the 55,103 total estimated plastic surgeons.For those cases in which the National Society did not provide its countrys total,a regression model was used to estimate the number of plastic surgeons in the country based on its population size and Gross Domestic Product.The Aesthetic Society,in collaboration with CosmetAssure,provided special assistance to this years study by permitting the use of its national statistics.Their information includes detailed statistics on more than 600 US-based surgeons.We appreciate The Aesthetic Societys continued support of this international research effort.Studies such as this must often address outlying responses.Though the outlying values may be legitimate,their presence can distort the averages,which provide the basis of the estimated projections.Significant outliers in this survey were adjusted in order to protect the reasonableness of the extrapolated values.Additional standard data editing procedures were followed to ensure responses met survey guidelines.All reported data values have been analyzed for statistical reasonableness.Country-specific data are only shown for those countries that provided a sufficient survey response for the figures to be considered valid.No adjustments other than standard data editing procedures were applied to country-specific results.The following procedures were included in the survey but are not represented in the accompanying tables due to an insufficient number of surgeons providing these treatments:Hair Transplantation,Penile Enlargement,Poly-L-Lactic Acid Injections,Polymethylmethacrylate Fillers,Dermabrasion,Microdermabrasion,Photo Rejuvenation,Tattoo Removal,Treatment of Leg Veins,and Sclerotherapy.The International Survey on Aesthetic/Cosmetic Procedures Performed in 2023 was compiled,tabulated,and analyzed by Industry Insights,Inc.(),an independent research firm based in Columbus,OH.The survey leader was Scott Hackworth,a CPA and data scientist who along with his firm has conducted various forms of research on trends in aesthetic plastic surgery for more than 30 years.OF THE INTERNATIONAL SURVEY ON AESTHETIC/COSMETIC PROCEDURESHIGHLIGHTSPERFORMED IN 2023INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 6 2023 STATISTICS AT A GLANCETop 5 surgical procedures worldwide absolute numbers and changes compared to 20221.Liposuction 2,237,966 procedures-2.9%2.Breast Augmentation 1,892,777 procedures-13.0%3.Eyelid Surgery 1,746,946 procedures 24.0%4.Abdominoplasty 1,153,539 procedures-2.3%5.Rhinoplasty 1,148,559 procedures 21.6%Top 5 non-surgical procedures worldwide absolute numbers and changes compared to 20221.Botulinum Toxin 8,877,991 procedures-3.7%2.Hyaluronic Acid 5,564,866 procedures 29.1%3.Hair Removal 1,608,447 procedures-10.6%4.Non-Surgical Skin Tightening 831,583 procedures 13.3%5.Non-Surgical Fat Reduction 631,212 procedures-18.9%Top 5 surgical proceduresfor women1.Liposuction 1,898,880 procedures2.Breast Augmentation 1,868,360 procedures3.Eyelid Surgery 1,353,566 procedures4.Abdominoplasty 1,033,264 procedures5.Breast Lift 903,266 proceduresTop 5 non-surgical procedures for women1.Botulinum Toxin 7,526,993 procedures2.Hyaluronic Acid 4,894,101 procedures3.Hair Removal 1,305,868 procedures4.Non-Surgical Skin Tightening 695,935 procedures5.Non-Surgical Fat Reduction 501,511 proceduresTop 5 surgical proceduresfor men1.Eyelid Surgery 393,380 procedures2.Gynecomastia 352,302 procedures3.Liposuction 339,086 procedures4.Rhinoplasty 290,492 procedures5.Fat Grafting Face 127,769 proceduresTop 5 non-surgical procedures for men1.Botulinum Toxin 1,350,999 procedures2.Hyaluronic Acid 670,765 procedures3.Hair Removal 302,579 procedures4.Non-Surgical Skin Tightening 135,648 procedures5.Non-Surgical Fat Reduction 129,701 proceduresINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 7 2023 STATISTICS AT A GLANCEmost common COSMETIC procedures byAGE GROUP 17 years or younger Botulinum Toxin 62,146 procedures1834 years old Botulinum Toxin 2,130,718 procedures3550 years old Botulinum Toxin 4,350,216 procedures5164 years old Botulinum Toxin 1,970,914 procedures65 years or older Botulinum Toxin 363,998 proceduresUS is the country with themost surgeons:7,750 surgeonsUS is the country with themost non-surgical procedures:4,405,599 procedures Brazil is the country with themost surgical procedures:2,185,038 procedures 19,182,141non-surgical procedurestotal procedures performed WORLDWIDE15,813,353surgical proceduresUSBRAZILPERFORMED BY PLASTIC SURGEONS IN 2023NUMBER OFWORLDWIDEPROCEDURESINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 9 NUMBER OF WORLDWIDE SURGICAL PROCEDURES PERFORMED BY PLASTIC SURGEONSRank SURGICAL PROCEDURESTotalPercentage of Total Surgical ProceduresTotal Procedures in 2022Total Procedures in 2019Percentage Change 2023 vs.2022Percentage Change 2023 vs.20191Liposuction 2,237,966 14.2%2,303,929 1,704,786-2.91.3+reast Augmentation 1,892,777 12.0%2,174,616 1,795,551-13.0%5.4yelid Surgery 1,746,946 11.0%1,409,103 1,259,839 24.08.7Jbdominoplasty 1,153,539 7.3%1,180,623 924,031-2.3$.8%5Rhinoplasty 1,148,559 7.34,468 821,890 21.69.7kreast Lift 903,266 5.75,026 741,284-5.4!.9%7Lip Enhancement/Perioral Procedure 901,991 5.7i9,264 N/A 29.0%N/A 8Buttock Augmentation 771,333 4.90,762 479,451-6.0.9at Grafting Face 741,061 4.7d8,894 598,823 14.2#.8Breast Reduction 686,125 4.3c2,860 600,219 8.4.3Face Lift 646,482 4.1T1,491 448,485 19.4D.1Neck Lift 452,639 2.90,593 260,747 13.0s.6Brow Lift 386,427 2.452,324 270,917 9.7B.6Gynecomastia 352,302 2.205,340 273,344 15.4(.9Breast Implant Removal 335,939 2.120,765 229,680 4.7F.3Ear Surgery 327,990 2.103,906 288,905 7.9.5Upper Arm Lift 244,977 1.5 4,011 168,289 20.1E.6Labiaplasty 189,058 1.24,086 164,667-2.6.8Facial Bone Contouring 153,749 1.08,115 108,536 11.3A.7 Thigh Lift 146,264 0.93,746 93,334 28.6V.7!Lower Body Lift 128,998 0.83,123 75,895 4.8p.0Buttock Lift 110,167 0.7,174 54,894 15.80.7#Vaginal Rejuvenation 84,495 0.5p,645 N/A 19.6%N/A 24Upper Body Lift 70,306 0.4T,120 N/A 29.9%N/A TOTAL SURGICAL PROCEDURES 15,813,353 14,986,982 11,363,569 5.59.2%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 10 NUMBER OF WORLDWIDE NON-SURGICAL PROCEDURES PERFORMED BY PLASTIC SURGEONSRank NON-SURGICAL PROCEDURESTotalPercentage of Total Non-Surgical ProceduresTotal Procedures in 2022Total Procedures in 2019Percentage Change 2023 vs.2022Percentage Change 2023 vs.20191Botulinum Toxin 8,877,991 46.3%9,221,419 6,271,488-3.7A.6%2Hyaluronic Acid 5,564,866 29.0%4,312,037 4,315,859 29.1(.9%3Hair Removal 1,608,447 8.4%1,798,253 1,042,951-10.6T.2%4Non-Surgical Skin Tightening 831,583 4.3s4,257 N/A 13.3%N/A 5Non-Surgical Fat Reduction 631,212 3.3w8,716 462,769-18.96.4lhemical Peel 553,785 2.94,616 369,497-34.4I.9ull Field Ablative 437,652 2.367,983 190,978 18.99.2alcium Hydroxylapatite 344,624 1.850,716 212,762-1.7b.0ellulite Treatment 331,981 1.7D9,314 N/A-26.1%N/A TOTAL NON-SURGICAL PROCEDURES 19,182,141 18,857,311 13,618,735 1.7.9%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 11 NUMBER OF WORLDWIDE SURGICAL PROCEDURES BY REGION OF THE BODY TOTAL SURGICAL PROCEDURES202320222019Percentage Change 2023 vs.2022Percentage Change 2023 vs.2019Brow Lift386,427352,324270,9179.7B.6r Surgery327,990303,906288,9057.9.5%Eyelid Surgery1,746,9461,409,1031,259,83924.08.7ce Lift646,482541,491448,48519.4D.1cial Bone Contouring153,749138,115108,53611.3A.7t Grafting Face741,061648,894598,82314.2#.8%Lip Enhancement/Perioral Procedure901,991699,264N/A29.0%N/ANeck Lift452,639400,593260,74713.0s.6%Rhinoplasty1,148,559944,468821,89021.69.7%TOTAL FACE&HEAD PROCEDURES 6,505,8435,438,1574,058,14319.6.3%Breast Augmentation1,892,7772,174,6161,795,551-13.0%5.4%Breast Implant Removal335,939320,765229,6804.7F.3%Breast Lift903,266955,026741,284-5.4!.9%Breast Reduction686,125632,860600,2198.4.3%Gynecomastia352,302305,340273,34415.4(.9%TOTAL BREAST PROCEDURES4,170,4094,388,6073,640,079-5.0.6dominoplasty1,153,5391,180,623924,031-2.3$.8%Buttock Augmentation771,333820,762479,451-6.0.9%Buttock Lift110,16795,17454,89415.80.7%Liposuction2,237,9662,303,9291,704,786-2.91.3%Lower Body Lift128,998123,12375,8954.8p.0%Thigh Lift146,264113,74693,33428.6V.7%Upper Arm Lift244,977204,011168,28920.1E.6%Upper Body Lift70,30654,120N/A29.9%N/ALabiaplasty189,058194,086164,667-2.6.8%Vaginal Rejuvenation84,49570,645N/A19.6%N/ATOTAL BODY&EXTREMITIES PROCEDURES5,137,1015,160,2183,665,347-0.4.2%TOTAL SURGICAL PROCEDURES15,813,35314,986,98211,363,5695.59.2CE&HEADBREAST BODY&EXTREMITIESINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 12 TOTAL NON-SURGICAL PROCEDURES202320222019Percentage Change 2023 vs.2022Percentage Change 2023 vs.2019Botulinum Toxin8,877,9919,221,4196,271,488-3.7A.6lcium Hydroxylapatite344,624350,716212,762-1.7b.0%Hyaluronic Acid5,564,8664,312,0374,315,85929.1(.9%TOTAL INJECTABLES PROCEDURES14,787,48113,884,17210,890,3686.55.8%Chemical Peel553,785844,616369,497-34.4I.9%Full Field Ablative437,652367,983190,97818.99.2%Non-Surgical Skin Tightening831,583734,257N/A13.3%N/ATOTAL FACIAL REJUVENATION PROCEDURES1,823,0201,946,8551,222,648-6.4I.1llulite Treatment331,981449,314N/A-26.1%N/AHair Removal1,608,4471,798,2531,042,951-10.6T.2%Non-Surgical Fat Reduction631,212778,716462,769-18.96.4%TOTAL OTHER PROCEDURES2,571,6403,026,2841,505,719-15.0p.8%TOTAL NON-SURGICAL PROCEDURES19,182,14118,857,31113,618,7351.7.9%INJECTABLESFACIALREJUVENATIONOTHERNUMBER OF WORLDWIDE NON-SURGICAL PROCEDURES BY TYPE OF PROCEDURETOTAL PROCEDURES34,995,49433,844,29324,982,3043.4.1%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 13 OVERVIEW OF ALL PROCEDURESINCREASED BY 3.4%TOTAL SURGICALPROCEDURES INCREASED BY 5.5%TOTAL NON-SURGICAL PROCEDURESINCREASED BY 1.7%5.5%1.7%TOTAL FACE&HEADprocedures 19.6%TOTAL BREASTprocedures-5.0%TOTAL BODY&EXTREMITIESprocedures-0.4%TOTAL INJECTABLESprocedures 6.5%TOTAL FACIAL REJUVENATIONprocedures-6.4%TOTALOTHERprocedures-15.0%Compared to 2022 statisticsTOTAL PROCEDURES IN 2023PROCEDURESBY COUNTRYINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 15 USUSTOTAL NUMBER OF PROCEDURES IN THE US6,196,701 FACE&HEADBrow Lift 31,097 Ear Surgery 31,554 Eyelid Surgery 122,092 Face Lift 94,158 Facial Bone Contouring 16,313 Fat Grafting Face 25,850 Lip Enhancement/Perioral Procedure 108,500 Neck Lift 42,526 Rhinoplasty 49,078 TOTAL FACE&HEAD 521,167 BREASTBreast Augmentation 242,596 Breast Implant Removal 74,109 Breast Lift 151,902 Breast Reduction 77,856 Gynecomastia 21,418 TOTAL BREAST 567,881 BODY&EXTREMITIESAbdominoplasty 193,439 Buttock Augmentation 23,661 Buttock Lift 13,131 Liposuction 383,919 Lower Body Lift 13,886 Thigh Lift 13,975 Upper Arm Lift 28,398 Upper Body Lift 9,739 Labiaplasty 18,316 Vaginal Rejuvenation 3,589 TOTAL BODY&EXTREMITIES 702,054 TOTAL SURGICAL PROCEDURES 1,791,102INJECTABLESBotulinum Toxin 2,499,859 Calcium Hydroxylapatite 84,817 Hyaluronic Acid 712,225 TOTAL INJECTABLES 3,296,901 TOTAL NON-SURGICAL PROCEDURES 4,405,599FACIAL REJUVENATIONChemical Peel 232,902 Full Field Ablative 118,661 Non-Surgical Skin Tightening 261,088 TOTAL FACIAL REJUVENATION 612,651 OTHERCellulite Treatment 22,217 Hair Removal 240,373 Non-Surgical Fat Reduction 233,458 TOTAL OTHER 496,047 MOST COMMON PROCEDURES TOTAL%OF TOTALLiposuction 383,919 21.4%Breast Augmentation 242,596 13.5dominoplasty 193,439 10.8%Breast Lift 151,902 8.5%Eyelid Surgery 122,092 6.8%MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 2,499,859 56.7%Hyaluronic Acid 712,225 16.2%Non-Surgical Skin Tightening 261,088 5.9%Hair Removal 240,373 5.5%Non-Surgical Fat Reduction 233,458 5.3%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 16 BRAZILBRAZILTOTAL NUMBER OF PROCEDURES IN BRAZIL 3,381,551 FACE&HEADBrow Lift 54,191 Ear Surgery 34,596 Eyelid Surgery 216,318 Face Lift 110,005 Facial Bone Contouring 19,845 Fat Grafting Face 84,931 Lip Enhancement/Perioral Procedure 122,781 Neck Lift 75,624 Rhinoplasty 87,215 TOTAL FACE&HEAD 805,507 BREASTBreast Augmentation 227,451 Breast Implant Removal 41,314 Breast Lift 140,675 Breast Reduction 95,251 Gynecomastia 46,463 TOTAL BREAST 551,153 BODY&EXTREMITIESAbdominoplasty 161,441 Buttock Augmentation 199,254 Buttock Lift 21,757 Liposuction 307,280 Lower Body Lift 25,817 Thigh Lift 21,725 Upper Arm Lift 36,515 Upper Body Lift 13,272 Labiaplasty 28,478 Vaginal Rejuvenation 12,839 TOTAL BODY&EXTREMITIES 828,377 TOTAL SURGICAL PROCEDURES 2,185,038INJECTABLESBotulinum Toxin 571,117 Calcium Hydroxylapatite 47,883 Hyaluronic Acid 429,391 TOTAL INJECTABLES 1,048,391 TOTAL NON-SURGICAL PROCEDURES 1,196,513FACIAL REJUVENATIONChemical Peel 18,832 Full Field Ablative 31,001 Non-Surgical Skin Tightening 25,140 TOTAL FACIAL REJUVENATION 74,973 OTHERCellulite Treatment 41,770 Hair Removal 16,412 Non-Surgical Fat Reduction 14,967 TOTAL OTHER 73,149 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 571,117 47.7%Hyaluronic Acid 429,391 35.9lcium Hydroxylapatite 47,883 4.0llulite Treatment 41,770 3.5%Full Field Ablative 31,001 2.6%MOST COMMON PROCEDURES TOTAL%OF TOTALLiposuction 307,280 14.1%Breast Augmentation 227,451 10.4%Eyelid Surgery 216,318 9.9%Buttock Augmentation 199,254 9.1dominoplasty 161,441 7.4%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 17 MEXICOMEXICOTOTAL NUMBER OF PROCEDURES IN MEXICO 1,714,952 FACE&HEADBrow Lift 24,833 Ear Surgery 12,945 Eyelid Surgery 83,386 Face Lift 31,942 Facial Bone Contouring 14,639 Fat Grafting Face 49,866 Lip Enhancement/Perioral Procedure 46,414 Neck Lift 33,009 Rhinoplasty 60,489 TOTAL FACE&HEAD 357,524 BREASTBreast Augmentation 101,264 Breast Implant Removal 16,667 Breast Lift 40,803 Breast Reduction 23,952 Gynecomastia 13,798 TOTAL BREAST 196,485 BODY&EXTREMITIESAbdominoplasty 71,197 Buttock Augmentation 99,959 Buttock Lift 12,160 Liposuction 145,261 Lower Body Lift 8,753 Thigh Lift 6,695 Upper Arm Lift 17,019 Upper Body Lift 6,188 Labiaplasty 6,809 Vaginal Rejuvenation 4,491 TOTAL BODY&EXTREMITIES 378,530 TOTAL SURGICAL PROCEDURES 932,539INJECTABLESBotulinum Toxin 372,064 Calcium Hydroxylapatite 10,944 Hyaluronic Acid 204,926 TOTAL INJECTABLES 587,934 TOTAL NON-SURGICAL PROCEDURES 782,413FACIAL REJUVENATIONChemical Peel 16,224 Full Field Ablative 14,816 Non-Surgical Skin Tightening 37,381 TOTAL FACIAL REJUVENATION 68,421 OTHERCellulite Treatment 32,563 Hair Removal 58,697 Non-Surgical Fat Reduction 34,799 TOTAL OTHER 126,058 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 372,064 47.6%Hyaluronic Acid 204,926 26.2%Hair Removal 58,697 7.5%Non-Surgical Skin Tightening 37,381 4.8%Non-Surgical Fat Reduction 34,799 4.4%MOST COMMON PROCEDURES TOTAL%OF TOTALLiposuction 145,261 15.6%Breast Augmentation 101,264 10.9%Buttock Augmentation 99,959 10.7%Eyelid Surgery 83,386 8.9dominoplasty 71,197 7.6%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 18 GERMANYGERMANYTOTAL NUMBER OF PROCEDURES IN GERMANY 1,244,466 FACE&HEADBrow Lift 11,498 Ear Surgery 7,399 Eyelid Surgery 71,604 Face Lift 14,024 Facial Bone Contouring 1,450 Fat Grafting Face 14,675 Lip Enhancement/Perioral Procedure 28,025 Neck Lift 9,851 Rhinoplasty 15,852 TOTAL FACE&HEAD 174,379 BREASTBreast Augmentation 71,464 Breast Implant Removal 8,436 Breast Lift 25,883 Breast Reduction 22,648 Gynecomastia 11,283 TOTAL BREAST 139,714 BODY&EXTREMITIESAbdominoplasty 30,789 Buttock Augmentation 5,085 Buttock Lift 2,346 Liposuction 80,519 Lower Body Lift 4,299 Thigh Lift 6,452 Upper Arm Lift 8,876 Upper Body Lift 1,544 Labiaplasty 8,198 Vaginal Rejuvenation 824 TOTAL BODY&EXTREMITIES 148,932 TOTAL SURGICAL PROCEDURES 463,026INJECTABLESBotulinum Toxin 421,684 Calcium Hydroxylapatite 13,618 Hyaluronic Acid 286,285 TOTAL INJECTABLES 721,587 TOTAL NON-SURGICAL PROCEDURES 781,440FACIAL REJUVENATIONChemical Peel 4,385 Full Field Ablative 9,283 Non-Surgical Skin Tightening 23,277 TOTAL FACIAL REJUVENATION 36,946 OTHERCellulite Treatment 1,185 Hair Removal 4,415 Non-Surgical Fat Reduction 17,307 TOTAL OTHER 22,907 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 421,684 54.0%Hyaluronic Acid 286,285 36.6%Non-Surgical Skin Tightening 23,277 3.0%Non-Surgical Fat Reduction 17,307 2.2lcium Hydroxylapatite 13,618 1.7%MOST COMMON PROCEDURES TOTAL%OF TOTALLiposuction 80,519 17.4%Eyelid Surgery 71,604 15.5%Breast Augmentation 71,464 15.4dominoplasty 30,789 6.6%Lip Enhancement/Perioral Procedure 28,025 6.1%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 19 ARGENTINAARGENTINATOTAL NUMBER OF PROCEDURES IN ARGENTINA 1,210,216 FACE&HEADBrow Lift 9,813 Ear Surgery 11,112 Eyelid Surgery 50,369 Face Lift 18,211 Facial Bone Contouring 2,598 Fat Grafting Face 14,715 Lip Enhancement/Perioral Procedure 47,166 Neck Lift 12,850 Rhinoplasty 48,268 TOTAL FACE&HEAD 215,101 BREASTBreast Augmentation 77,831 Breast Implant Removal 12,323 Breast Lift 24,844 Breast Reduction 19,062 Gynecomastia 7,579 TOTAL BREAST 141,638 BODY&EXTREMITIESAbdominoplasty 35,296 Buttock Augmentation 15,575 Buttock Lift 2,186 Liposuction 45,528 Lower Body Lift 2,766 Thigh Lift 2,268 Upper Arm Lift 6,648 Upper Body Lift 1,401 Labiaplasty 5,168 Vaginal Rejuvenation 2,311 TOTAL BODY&EXTREMITIES 119,148 TOTAL SURGICAL PROCEDURES 475,887INJECTABLESBotulinum Toxin 208,277 Calcium Hydroxylapatite 19,708 Hyaluronic Acid 233,250 TOTAL INJECTABLES 461,235 TOTAL NON-SURGICAL PROCEDURES 734,329FACIAL REJUVENATIONChemical Peel 5,290 Full Field Ablative 19,299 Non-Surgical Skin Tightening 23,504 TOTAL FACIAL REJUVENATION 48,094 OTHERCellulite Treatment 41,348 Hair Removal 133,166 Non-Surgical Fat Reduction 50,486 TOTAL OTHER 225,000 MOST COMMON PROCEDURES TOTAL%OF TOTALHyaluronic Acid 233,250 31.8%Botulinum Toxin 208,277 28.4%Hair Removal 133,166 18.1%Non-Surgical Fat Reduction 50,486 6.9llulite Treatment 41,348 5.6%MOST COMMON PROCEDURES TOTAL%OF TOTALBreast Augmentation 77,831 16.4%Eyelid Surgery 50,369 10.6%Rhinoplasty 48,268 10.1%Lip Enhancement/Perioral Procedure 47,166 9.9%Liposuction 45,528 9.6%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 20 TURKIYETURKIYETOTAL NUMBER OF PROCEDURES IN TURKIYE 1,201,139 FACE&HEADBrow Lift 19,322 Ear Surgery 11,341 Eyelid Surgery 61,075 Face Lift 19,457 Facial Bone Contouring 6,451 Fat Grafting Face 33,098 Lip Enhancement/Perioral Procedure 23,818 Neck Lift 12,053 Rhinoplasty 83,146 TOTAL FACE&HEAD 269,761 BREASTBreast Augmentation 53,800 Breast Implant Removal 6,203 Breast Lift 29,566 Breast Reduction 29,074 Gynecomastia 15,271 TOTAL BREAST 133,914 BODY&EXTREMITIESAbdominoplasty 36,409 Buttock Augmentation 17,330 Buttock Lift 2,483 Liposuction 67,962 Lower Body Lift 4,045 Thigh Lift 6,092 Upper Arm Lift 7,549 Upper Body Lift 2,089 Labiaplasty 3,582 Vaginal Rejuvenation 1,906 TOTAL BODY&EXTREMITIES 149,447 TOTAL SURGICAL PROCEDURES 553,122INJECTABLESBotulinum Toxin 396,625 Calcium Hydroxylapatite 5,800 Hyaluronic Acid 182,080 TOTAL INJECTABLES 584,505 TOTAL NON-SURGICAL PROCEDURES 648,018FACIAL REJUVENATIONChemical Peel 3,636 Full Field Ablative 5,331 Non-Surgical Skin Tightening 21,066 TOTAL FACIAL REJUVENATION 30,033 OTHERCellulite Treatment 2,378 Hair Removal 17,057 Non-Surgical Fat Reduction 14,045 TOTAL OTHER 33,479 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 396,625 61.2%Hyaluronic Acid 182,080 28.1%Non-Surgical Skin Tightening 21,066 3.3%Hair Removal 17,057 2.6%Non-Surgical Fat Reduction 14,045 2.2%MOST COMMON PROCEDURES TOTAL%OF TOTALRhinoplasty 83,146 15.0%Liposuction 67,962 12.3%Eyelid Surgery 61,075 11.0%Breast Augmentation 53,800 9.7dominoplasty 36,409 6.6%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 21 INDIAINDIATOTAL NUMBER OF PROCEDURES IN INDIA 1,028,723 FACE&HEADBrow Lift 7,640 Ear Surgery 21,619 Eyelid Surgery 40,465 Face Lift 8,572 Facial Bone Contouring 9,184 Fat Grafting Face 34,334 Lip Enhancement/Perioral Procedure 23,466 Neck Lift 8,692 Rhinoplasty 71,256 TOTAL FACE&HEAD 225,227 BREASTBreast Augmentation 47,690 Breast Implant Removal 3,617 Breast Lift 15,285 Breast Reduction 20,506 Gynecomastia 42,719 TOTAL BREAST 129,818 BODY&EXTREMITIESAbdominoplasty 30,793 Buttock Augmentation 9,223 Buttock Lift 914 Liposuction 102,290 Lower Body Lift 4,121 Thigh Lift 4,621 Upper Arm Lift 7,379 Upper Body Lift 2,325 Labiaplasty 6,747 Vaginal Rejuvenation 8,333 TOTAL BODY&EXTREMITIES 176,747 TOTAL SURGICAL PROCEDURES 531,792INJECTABLESBotulinum Toxin 115,194 Calcium Hydroxylapatite 250 Hyaluronic Acid 107,100 TOTAL INJECTABLES 222,544 TOTAL NON-SURGICAL PROCEDURES 496,931FACIAL REJUVENATIONChemical Peel 70,198 Full Field Ablative 24,075 Non-Surgical Skin Tightening 45,463 TOTAL FACIAL REJUVENATION 139,736 OTHERCellulite Treatment 3,495 Hair Removal 97,601 Non-Surgical Fat Reduction 33,555 TOTAL OTHER 134,651 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 115,194 23.2%Hyaluronic Acid 107,100 21.6%Hair Removal 97,601 19.6%Chemical Peel 70,198 14.1%Non-Surgical Skin Tightening 45,463 9.1%MOST COMMON PROCEDURES TOTAL%OF TOTALLiposuction 102,290 19.2%Rhinoplasty 71,256 13.4%Breast Augmentation 47,690 9.0%Gynecomastia 42,719 8.0%Eyelid Surgery 40,465 7.6%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 22 FRANCEFRANCETOTAL NUMBER OF PROCEDURES IN FRANCE 883,700 FACE&HEADBrow Lift 3,200 Ear Surgery 7,900 Eyelid Surgery 35,900 Face Lift 20,700 Facial Bone Contouring 1,500 Fat Grafting Face 21,400 Lip Enhancement/Perioral Procedure 13,700 Neck Lift 11,700 Rhinoplasty 17,600 TOTAL FACE&HEAD 133,600 BREASTBreast Augmentation 43,800 Breast Implant Removal 5,500 Breast Lift 18,300 Breast Reduction 25,100 Gynecomastia 5,200 TOTAL BREAST 97,900 BODY&EXTREMITIESAbdominoplasty 24,200 Buttock Augmentation 7,600 Buttock Lift 1,300 Liposuction 35,500 Lower Body Lift 3,200 Thigh Lift 4,700 Upper Arm Lift 6,300 Upper Body Lift 400 Labiaplasty 6,900 Vaginal Rejuvenation 2,000 TOTAL BODY&EXTREMITIES 92,100 TOTAL SURGICAL PROCEDURES 323,600INJECTABLESBotulinum Toxin 208,900 Calcium Hydroxylapatite 10,300 Hyaluronic Acid 234,900 TOTAL INJECTABLES 454,100 TOTAL NON-SURGICAL PROCEDURES 560,100FACIAL REJUVENATIONChemical Peel 9,000 Full Field Ablative 3,800 Non-Surgical Skin Tightening 19,700 TOTAL FACIAL REJUVENATION 32,500 OTHERCellulite Treatment 4,800 Hair Removal 60,000 Non-Surgical Fat Reduction 8,700 TOTAL OTHER 73,500 MOST COMMON PROCEDURES TOTAL%OF TOTALHyaluronic Acid 234,900 41.9%Botulinum Toxin 208,900 37.3%Hair Removal 60,000 10.7%Non-Surgical Skin Tightening 19,700 3.5lcium Hydroxylapatite 10,300 1.8%MOST COMMON PROCEDURES TOTAL%OF TOTALBreast Augmentation 43,800 13.5%Eyelid Surgery 35,900 11.1%Liposuction 35,500 11.0%Breast Reduction 25,100 7.8dominoplasty 24,200 7.5%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 23 ITALYITALYTOTAL NUMBER OF PROCEDURES IN ITALY 757,442 FACE&HEADBrow Lift 6,613 Ear Surgery 6,440 Eyelid Surgery 31,512 Face Lift 7,633 Facial Bone Contouring 2,781 Fat Grafting Face 12,452 Lip Enhancement/Perioral Procedure 27,202 Neck Lift 5,685 Rhinoplasty 18,083 TOTAL FACE&HEAD 118,401 BREASTBreast Augmentation 38,949 Breast Implant Removal 6,772 Breast Lift 16,244 Breast Reduction 9,743 Gynecomastia 5,839 TOTAL BREAST 77,547 BODY&EXTREMITIESAbdominoplasty 15,719 Buttock Augmentation 7,207 Buttock Lift 902 Liposuction 26,652 Lower Body Lift 1,274 Thigh Lift 3,466 Upper Arm Lift 5,948 Upper Body Lift 339 Labiaplasty 3,975 Vaginal Rejuvenation 823 TOTAL BODY&EXTREMITIES 66,305 TOTAL SURGICAL PROCEDURES 262,254INJECTABLESBotulinum Toxin 194,335 Calcium Hydroxylapatite 12,468 Hyaluronic Acid 190,606 TOTAL INJECTABLES 397,409 TOTAL NON-SURGICAL PROCEDURES 495,188FACIAL REJUVENATIONChemical Peel 22,442 Full Field Ablative 11,179 Non-Surgical Skin Tightening 14,982 TOTAL FACIAL REJUVENATION 48,603 OTHERCellulite Treatment 13,787 Hair Removal 26,296 Non-Surgical Fat Reduction 9,093 TOTAL OTHER 49,176 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 194,335 39.2%Hyaluronic Acid 190,606 38.5%Hair Removal 26,296 5.3%Chemical Peel 22,442 4.5%Non-Surgical Skin Tightening 14,982 3.0%MOST COMMON PROCEDURES TOTAL%OF TOTALBreast Augmentation 38,949 14.9%Eyelid Surgery 31,512 12.0%Lip Enhancement/Perioral Procedure 27,202 10.4%Liposuction 26,652 10.2%Rhinoplasty 18,083 6.9%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 24 SPAINSPAINTOTAL NUMBER OF PROCEDURES IN SPAIN 528,608 FACE&HEADBrow Lift 5,430 Ear Surgery 7,775 Eyelid Surgery 40,252 Face Lift 6,269 Facial Bone Contouring 1,821 Fat Grafting Face 11,946 Lip Enhancement/Perioral Procedure 20,178 Neck Lift 5,025 Rhinoplasty 13,566 TOTAL FACE&HEAD 112,262 BREASTBreast Augmentation 44,663 Breast Implant Removal 7,145 Breast Lift 18,859 Breast Reduction 12,847 Gynecomastia 5,418 TOTAL BREAST 88,931 BODY&EXTREMITIESAbdominoplasty 12,319 Buttock Augmentation 7,516 Buttock Lift 364 Liposuction 25,481 Lower Body Lift 950 Thigh Lift 2,271 Upper Arm Lift 2,662 Upper Body Lift 198 Labiaplasty 5,226 Vaginal Rejuvenation 1,292 TOTAL BODY&EXTREMITIES 58,279 TOTAL SURGICAL PROCEDURES 259,473INJECTABLESBotulinum Toxin 89,186 Calcium Hydroxylapatite 8,364 Hyaluronic Acid 114,200 TOTAL INJECTABLES 211,750 TOTAL NON-SURGICAL PROCEDURES 269,136FACIAL REJUVENATIONChemical Peel 7,975 Full Field Ablative 8,921 Non-Surgical Skin Tightening 8,821 TOTAL FACIAL REJUVENATION 25,717 OTHERCellulite Treatment 7,227 Hair Removal 18,992 Non-Surgical Fat Reduction 5,449 TOTAL OTHER 31,668 MOST COMMON PROCEDURES TOTAL%OF TOTALHyaluronic Acid 114,200 42.4%Botulinum Toxin 89,186 33.1%Hair Removal 18,992 7.1%Full Field Ablative 8,921 3.3%Non-Surgical Skin Tightening 8,821 3.3%MOST COMMON PROCEDURES TOTAL%OF TOTALBreast Augmentation 44,663 17.2%Eyelid Surgery 40,252 15.5%Liposuction 25,481 9.8%Lip Enhancement/Perioral Procedure 20,178 7.8%Breast Lift 18,859 7.3%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 25 COLOMBIACOLOMBIATOTAL NUMBER OF PROCEDURES IN COLOMBIA 447,268 FACE&HEADBrow Lift 6,284 Ear Surgery 4,081 Eyelid Surgery 24,932 Face Lift 8,259 Facial Bone Contouring 2,222 Fat Grafting Face 13,711 Lip Enhancement/Perioral Procedure 10,701 Neck Lift 6,306 Rhinoplasty 16,809 TOTAL FACE&HEAD 93,304 BREASTBreast Augmentation 28,606 Breast Implant Removal 9,406 Breast Lift 18,173 Breast Reduction 12,465 Gynecomastia 4,430 TOTAL BREAST 73,081 BODY&EXTREMITIESAbdominoplasty 20,195 Buttock Augmentation 29,578 Buttock Lift 1,606 Liposuction 39,744 Lower Body Lift 1,774 Thigh Lift 2,746 Upper Arm Lift 3,122 Upper Body Lift 810 Labiaplasty 2,739 Vaginal Rejuvenation 2,172 TOTAL BODY&EXTREMITIES 104,485 TOTAL SURGICAL PROCEDURES 270,870INJECTABLESBotulinum Toxin 74,653 Calcium Hydroxylapatite 7,899 Hyaluronic Acid 43,230 TOTAL INJECTABLES 125,782 TOTAL NON-SURGICAL PROCEDURES 176,399FACIAL REJUVENATIONChemical Peel 998 Full Field Ablative 2,371 Non-Surgical Skin Tightening 10,878 TOTAL FACIAL REJUVENATION 14,248 OTHERCellulite Treatment 3,462 Hair Removal 28,288 Non-Surgical Fat Reduction 4,619 TOTAL OTHER 36,369 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 74,653 42.3%Hyaluronic Acid 43,230 24.5%Hair Removal 28,288 16.0%Non-Surgical Skin Tightening 10,878 6.2lcium Hydroxylapatite 7,899 4.5%MOST COMMON PROCEDURES TOTAL%OF TOTALLiposuction 39,744 14.7%Buttock Augmentation 29,578 10.9%Breast Augmentation 28,606 10.6%Eyelid Surgery 24,932 9.2dominoplasty 20,195 7.5%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 26 PERUPERUTOTAL NUMBER OF PROCEDURES IN PERU 416,588 FACE&HEADBrow Lift 9,200 Ear Surgery 5,003 Eyelid Surgery 23,575 Face Lift 10,753 Facial Bone Contouring 4,715 Fat Grafting Face 15,525 Lip Enhancement/Perioral Procedure 10,235 Neck Lift 8,050 Rhinoplasty 44,678 TOTAL FACE&HEAD 131,733 BREASTBreast Augmentation 19,665 Breast Implant Removal 2,990 Breast Lift 7,993 Breast Reduction 5,520 Gynecomastia 5,175 TOTAL BREAST 41,343 BODY&EXTREMITIESAbdominoplasty 12,075 Buttock Augmentation 21,965 Buttock Lift 1,725 Liposuction 28,118 Lower Body Lift 115 Thigh Lift 403 Upper Arm Lift 2,358 Upper Body Lift 230 Labiaplasty 1,150 Vaginal Rejuvenation 863 TOTAL BODY&EXTREMITIES 69,000 TOTAL SURGICAL PROCEDURES 242,075INJECTABLESBotulinum Toxin 87,458 Calcium Hydroxylapatite 2,990 Hyaluronic Acid 50,428 TOTAL INJECTABLES 140,875 TOTAL NON-SURGICAL PROCEDURES 174,513FACIAL REJUVENATIONChemical Peel 1,955 Full Field Ablative 7,360 Non-Surgical Skin Tightening 4,370 TOTAL FACIAL REJUVENATION 13,685 OTHERCellulite Treatment 1,150 Hair Removal 13,225 Non-Surgical Fat Reduction 5,578 TOTAL OTHER 19,953 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 87,458 50.1%Hyaluronic Acid 50,428 28.9%Hair Removal 13,225 7.6%Full Field Ablative 7,360 4.2%Non-Surgical Fat Reduction 5,578 3.2%MOST COMMON PROCEDURES TOTAL%OF TOTALRhinoplasty 44,678 18.5%Liposuction 28,118 11.6%Eyelid Surgery 23,575 9.7%Buttock Augmentation 21,965 9.1%Breast Augmentation 19,665 8.1%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 27 IRANIRANTOTAL NUMBER OF PROCEDURES IN IRAN 407,653 FACE&HEADBrow Lift 8,055 Ear Surgery 4,050 Eyelid Surgery 29,160 Face Lift 11,295 Facial Bone Contouring 3,195 Fat Grafting Face 17,955 Lip Enhancement/Perioral Procedure 10,260 Neck Lift 8,730 Rhinoplasty 45,225 TOTAL FACE&HEAD 137,925 BREASTBreast Augmentation 18,585 Breast Implant Removal 1,665 Breast Lift 10,440 Breast Reduction 12,240 Gynecomastia 6,885 TOTAL BREAST 49,815 BODY&EXTREMITIESAbdominoplasty 17,100 Buttock Augmentation 11,700 Buttock Lift 2,160 Liposuction 33,840 Lower Body Lift 2,025 Thigh Lift 1,845 Upper Arm Lift 4,410 Upper Body Lift 2,025 Labiaplasty 1,080 Vaginal Rejuvenation 135 TOTAL BODY&EXTREMITIES 76,320 TOTAL SURGICAL PROCEDURES 264,060INJECTABLESBotulinum Toxin 89,609 Calcium Hydroxylapatite 252 Hyaluronic Acid 35,955 TOTAL INJECTABLES 125,816 TOTAL NON-SURGICAL PROCEDURES 143,593FACIAL REJUVENATIONChemical Peel 44 Full Field Ablative 3,295 Non-Surgical Skin Tightening 5,992 TOTAL FACIAL REJUVENATION 9,331 OTHERCellulite Treatment 3,459 Hair Removal 3,614 Non-Surgical Fat Reduction 1,374 TOTAL OTHER 8,447 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 89,609 62.4%Hyaluronic Acid 35,955 25.0%Non-Surgical Skin Tightening 5,992 4.2%Hair Removal 3,614 2.5llulite Treatment 3,459 2.4%MOST COMMON PROCEDURES TOTAL%OF TOTALRhinoplasty 45,225 17.1%Liposuction 33,840 12.8%Eyelid Surgery 29,160 11.0%Breast Augmentation 18,585 7.0t Grafting Face 17,955 6.8%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 28 VENEZUELAVENEZUELATOTAL NUMBER OF PROCEDURES IN VENEZUELA 362,283 FACE&HEADBrow Lift 5,510 Ear Surgery 3,843 Eyelid Surgery 20,373 Face Lift 9,063 Facial Bone Contouring 580 Fat Grafting Face 12,180 Lip Enhancement/Perioral Procedure 7,540 Neck Lift 5,655 Rhinoplasty 6,090 TOTAL FACE&HEAD 70,833 BREASTBreast Augmentation 21,315 Breast Implant Removal 5,873 Breast Lift 13,268 Breast Reduction 6,960 Gynecomastia 2,320 TOTAL BREAST 49,735 BODY&EXTREMITIESAbdominoplasty 15,878 Buttock Augmentation 9,643 Buttock Lift 3,915 Liposuction 20,300 Lower Body Lift 1,885 Thigh Lift 1,885 Upper Arm Lift 1,595 Upper Body Lift 1,305 Labiaplasty 2,538 Vaginal Rejuvenation 798 TOTAL BODY&EXTREMITIES 59,740 TOTAL SURGICAL PROCEDURES 180,308INJECTABLESBotulinum Toxin 71,413 Calcium Hydroxylapatite 5,365 Hyaluronic Acid 29,943 TOTAL INJECTABLES 106,720 TOTAL NON-SURGICAL PROCEDURES 181,975FACIAL REJUVENATIONChemical Peel 2,610 Full Field Ablative 5,873 Non-Surgical Skin Tightening 17,618 TOTAL FACIAL REJUVENATION 26,100 OTHERCellulite Treatment 8,990 Hair Removal 29,943 Non-Surgical Fat Reduction 10,223 TOTAL OTHER 49,155 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 71,413 39.2%Hyaluronic Acid 29,943 16.5%Hair Removal 29,943 16.5%Non-Surgical Skin Tightening 17,618 9.7%Non-Surgical Fat Reduction 10,223 5.6%MOST COMMON PROCEDURES TOTAL%OF TOTALBreast Augmentation 21,315 11.8%Eyelid Surgery 20,373 11.3%Liposuction 20,300 11.3dominoplasty 15,878 8.8%Breast Lift 13,268 7.4%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 29 ROMANIAROMANIATOTAL NUMBER OF PROCEDURES IN ROMANIA 269,173 FACE&HEADBrow Lift 2,533 Ear Surgery 2,313 Eyelid Surgery 8,611 Face Lift 2,597 Facial Bone Contouring 630 Fat Grafting Face 4,375 Lip Enhancement/Perioral Procedure 10,267 Neck Lift 1,389 Rhinoplasty 8,188 TOTAL FACE&HEAD 40,902 BREASTBreast Augmentation 18,347 Breast Implant Removal 1,200 Breast Lift 7,561 Breast Reduction 3,695 Gynecomastia 1,837 TOTAL BREAST 32,639 BODY&EXTREMITIESAbdominoplasty 5,449 Buttock Augmentation 1,537 Buttock Lift 566 Liposuction 6,867 Lower Body Lift 863 Thigh Lift 1,269 Upper Arm Lift 936 Upper Body Lift 642 Labiaplasty 1,771 Vaginal Rejuvenation 989 TOTAL BODY&EXTREMITIES 20,890 TOTAL SURGICAL PROCEDURES 94,431INJECTABLESBotulinum Toxin 86,686 Calcium Hydroxylapatite 1,956 Hyaluronic Acid 72,380 TOTAL INJECTABLES 161,022 TOTAL NON-SURGICAL PROCEDURES 174,742FACIAL REJUVENATIONChemical Peel 3,581 Full Field Ablative 3,100 Non-Surgical Skin Tightening 2,295 TOTAL FACIAL REJUVENATION 8,976 OTHERCellulite Treatment 931 Hair Removal 2,742 Non-Surgical Fat Reduction 1,070 TOTAL OTHER 4,743 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 86,686 49.6%Hyaluronic Acid 72,380 41.4%Chemical Peel 3,581 2.0%Full Field Ablative 3,100 1.8%Hair Removal 2,742 1.6%MOST COMMON PROCEDURES TOTAL%OF TOTALBreast Augmentation 18,347 19.4%Lip Enhancement/Perioral Procedure 10,267 10.9%Eyelid Surgery 8,611 9.1%Rhinoplasty 8,188 8.7%Breast Lift 7,561 8.0%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 30 UKUKTOTAL NUMBER OF PROCEDURES IN THE UK 224,523 FACE&HEADBrow Lift 2,015 Ear Surgery 4,846 Eyelid Surgery 15,186 Face Lift 8,476 Facial Bone Contouring 441 Fat Grafting Face 2,280 Lip Enhancement/Perioral Procedure 7,734 Neck Lift 5,131 Rhinoplasty 8,637 TOTAL FACE&HEAD 54,745 BREASTBreast Augmentation 31,542 Breast Implant Removal 5,565 Breast Lift 12,697 Breast Reduction 13,188 Gynecomastia 3,355 TOTAL BREAST 66,347 BODY&EXTREMITIESAbdominoplasty 11,425 Buttock Augmentation 1,875 Buttock Lift 231 Liposuction 18,831 Lower Body Lift 619 Thigh Lift 1,285 Upper Arm Lift 1,829 Upper Body Lift 504 Labiaplasty 3,625 Vaginal Rejuvenation 76 TOTAL BODY&EXTREMITIES 40,300 TOTAL SURGICAL PROCEDURES 161,392INJECTABLESBotulinum Toxin 30,835 Calcium Hydroxylapatite 554 Hyaluronic Acid 28,680 TOTAL INJECTABLES 60,070 TOTAL NON-SURGICAL PROCEDURES 63,130FACIAL REJUVENATIONChemical Peel 719 Full Field Ablative 284 Non-Surgical Skin Tightening 1,137 TOTAL FACIAL REJUVENATION 2,139 OTHERCellulite Treatment 153 Hair Removal 424 Non-Surgical Fat Reduction 344 TOTAL OTHER 922 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 30,835 48.8%Hyaluronic Acid 28,680 45.4%Non-Surgical Skin Tightening 1,137 1.8%Chemical Peel 719 1.1lcium Hydroxylapatite 554 0.9%MOST COMMON PROCEDURES TOTAL%OF TOTALBreast Augmentation 31,542 19.5%Liposuction 18,831 11.7%Eyelid Surgery 15,186 9.4%Breast Reduction 13,188 8.2%Breast Lift 12,697 7.9%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 31 BELGIUMBELGIUMTOTAL NUMBER OF PROCEDURES IN BELGIUM 223,412 FACE&HEADBrow Lift 2,077 Ear Surgery 3,417 Eyelid Surgery 16,214 Face Lift 3,317 Facial Bone Contouring 134 Fat Grafting Face 3,652 Lip Enhancement/Perioral Procedure 4,456 Neck Lift 2,479 Rhinoplasty 2,111 TOTAL FACE&HEAD 37,855 BREASTBreast Augmentation 14,271 Breast Implant Removal 2,948 Breast Lift 5,997 Breast Reduction 5,394 Gynecomastia 1,742 TOTAL BREAST 30,351 BODY&EXTREMITIESAbdominoplasty 7,203 Buttock Augmentation 2,580 Buttock Lift 871 Liposuction 11,491 Lower Body Lift 838 Thigh Lift 1,541 Upper Arm Lift 1,843 Upper Body Lift 603 Labiaplasty 1,374 Vaginal Rejuvenation 235 TOTAL BODY&EXTREMITIES 28,576 TOTAL SURGICAL PROCEDURES 96,782 INJECTABLESBotulinum Toxin 66,129 Calcium Hydroxylapatite 1,742 Hyaluronic Acid 41,105 TOTAL INJECTABLES 108,976 TOTAL NON-SURGICAL PROCEDURES 126,630FACIAL REJUVENATIONChemical Peel 871 Full Field Ablative 1,742 Non-Surgical Skin Tightening 3,685 TOTAL FACIAL REJUVENATION 6,298 OTHERCellulite Treatment 2,814 Hair Removal 6,332 Non-Surgical Fat Reduction 2,211 TOTAL OTHER 11,357 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 66,129 52.2%Hyaluronic Acid 41,105 32.5%Hair Removal 6,332 5.0%Non-Surgical Skin Tightening 3,685 2.9llulite Treatment 2,814 2.2%MOST COMMON PROCEDURES TOTAL%OF TOTALEyelid Surgery 16,214 16.8%Breast Augmentation 14,271 14.7%Liposuction 11,491 11.9dominoplasty 7,203 7.4%Breast Lift 5,997 6.2%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 32 GREECEGREECETOTAL NUMBER OF PROCEDURES IN GREECE 194,856 FACE&HEADBrow Lift 960 Ear Surgery 1,636 Eyelid Surgery 6,557 Face Lift 1,695 Facial Bone Contouring 165 Fat Grafting Face 3,382 Lip Enhancement/Perioral Procedure 2,613 Neck Lift 1,561 Rhinoplasty 2,292 TOTAL FACE&HEAD 20,861 BREASTBreast Augmentation 4,972 Breast Implant Removal 572 Breast Lift 1,941 Breast Reduction 1,684 Gynecomastia 1,132 TOTAL BREAST 10,301 BODY&EXTREMITIESAbdominoplasty 2,224 Buttock Augmentation 1,249 Buttock Lift 166 Liposuction 6,463 Lower Body Lift 241 Thigh Lift 506 Upper Arm Lift 731 Upper Body Lift 247 Labiaplasty 571 Vaginal Rejuvenation 350 TOTAL BODY&EXTREMITIES 12,749 TOTAL SURGICAL PROCEDURES 43,911INJECTABLESBotulinum Toxin 46,087 Calcium Hydroxylapatite 657 Hyaluronic Acid 48,954 TOTAL INJECTABLES 95,698 TOTAL NON-SURGICAL PROCEDURES 150,945FACIAL REJUVENATIONChemical Peel 3,048 Full Field Ablative 4,804 Non-Surgical Skin Tightening 4,538 TOTAL FACIAL REJUVENATION 12,389 OTHERCellulite Treatment 4,299 Hair Removal 35,148 Non-Surgical Fat Reduction 3,412 TOTAL OTHER 42,858 MOST COMMON PROCEDURES TOTAL%OF TOTALHyaluronic Acid 48,954 32.4%Botulinum Toxin 46,087 30.5%Hair Removal 35,148 23.3%Full Field Ablative 4,804 3.2%Non-Surgical Skin Tightening 4,538 3.0%MOST COMMON PROCEDURES TOTAL%OF TOTALEyelid Surgery 6,557 14.9%Liposuction 6,463 14.7%Breast Augmentation 4,972 11.3t Grafting Face 3,382 7.7%Lip Enhancement/Perioral Procedure 2,613 6.0%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 33 THAILANDTHAILANDTOTAL NUMBER OF PROCEDURES IN THAILAND 172,840 FACE&HEADBrow Lift 5,895 Ear Surgery 2,582 Eyelid Surgery 27,357 Face Lift 7,657 Facial Bone Contouring 2,954 Fat Grafting Face 8,083 Lip Enhancement/Perioral Procedure 3,416 Neck Lift 5,018 Rhinoplasty 17,885 TOTAL FACE&HEAD 80,849 BREASTBreast Augmentation 15,321 Breast Implant Removal 2,351 Breast Lift 5,436 Breast Reduction 3,658 Gynecomastia 1,542 TOTAL BREAST 28,307 BODY&EXTREMITIESAbdominoplasty 5,878 Buttock Augmentation 1,794 Buttock Lift 753 Liposuction 11,927 Lower Body Lift 1,246 Thigh Lift 890 Upper Arm Lift 1,983 Upper Body Lift 743 Labiaplasty 1,063 Vaginal Rejuvenation 742 TOTAL BODY&EXTREMITIES 27,019 TOTAL SURGICAL PROCEDURES 136,174INJECTABLESBotulinum Toxin 27,835 Calcium Hydroxylapatite 0 Hyaluronic Acid 4,250 TOTAL INJECTABLES 32,086 TOTAL NON-SURGICAL PROCEDURES 36,666FACIAL REJUVENATIONChemical Peel 992 Full Field Ablative 174 Non-Surgical Skin Tightening 1,967 TOTAL FACIAL REJUVENATION 3,133 OTHERCellulite Treatment 227 Hair Removal 577 Non-Surgical Fat Reduction 643 TOTAL OTHER 1,447 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 27,835 75.9%Hyaluronic Acid 4,250 11.6%Non-Surgical Skin Tightening 1,967 5.4%Chemical Peel 992 2.7%Non-Surgical Fat Reduction 643 1.8%MOST COMMON PROCEDURES TOTAL%OF TOTALEyelid Surgery 27,357 20.1%Rhinoplasty 17,885 13.1%Breast Augmentation 15,321 11.3%Liposuction 11,927 8.8t Grafting Face 8,083 5.9%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 34 SYRIASYRIATOTAL NUMBER OF PROCEDURES IN SYRIA 153,040 FACE&HEADBrow Lift 2,040 Ear Surgery 1,000 Eyelid Surgery 6,900 Face Lift 2,240 Facial Bone Contouring 530 Fat Grafting Face 3,970 Lip Enhancement/Perioral Procedure 4,170 Neck Lift 2,450 Rhinoplasty 6,250 TOTAL FACE&HEAD 29,550 BREASTBreast Augmentation 3,870 Breast Implant Removal 490 Breast Lift 1,890 Breast Reduction 1,630 Gynecomastia 1,310 TOTAL BREAST 9,190 BODY&EXTREMITIESAbdominoplasty 3,650 Buttock Augmentation 2,780 Buttock Lift 430 Liposuction 6,240 Lower Body Lift 800 Thigh Lift 750 Upper Arm Lift 1,150 Upper Body Lift 340 Labiaplasty 470 Vaginal Rejuvenation 440 TOTAL BODY&EXTREMITIES 17,050 TOTAL SURGICAL PROCEDURES 55,790INJECTABLESBotulinum Toxin 37,530 Calcium Hydroxylapatite 300 Hyaluronic Acid 26,270 TOTAL INJECTABLES 64,100 TOTAL NON-SURGICAL PROCEDURES 97,250FACIAL REJUVENATIONChemical Peel 1,570 Full Field Ablative 2,120 Non-Surgical Skin Tightening 3,300 TOTAL FACIAL REJUVENATION 6,990 OTHERCellulite Treatment 1,070 Hair Removal 23,460 Non-Surgical Fat Reduction 1,630 TOTAL OTHER 26,160 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 37,530 38.6%Hyaluronic Acid 26,270 27.0%Hair Removal 23,460 24.1%Non-Surgical Skin Tightening 3,300 3.4%Full Field Ablative 2,120 2.2%MOST COMMON PROCEDURES TOTAL%OF TOTALEyelid Surgery 6,900 12.4%Rhinoplasty 6,250 11.2%Liposuction 6,240 11.2%Lip Enhancement/Perioral Procedure 4,170 7.5t Grafting Face 3,970 7.1%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 35 SOUTH AFRICATOTAL NUMBER OF PROCEDURES IN SOUTH AFRICA 85,869 FACE&HEADBrow Lift 507 Ear Surgery 642 Eyelid Surgery 5,864 Face Lift 2,451 Facial Bone Contouring 17 Fat Grafting Face 3,397 Lip Enhancement/Perioral Procedure 2,332 Neck Lift 1,352 Rhinoplasty 1,707 TOTAL FACE&HEAD 18,269 BREASTBreast Augmentation 4,749 Breast Implant Removal 1,301 Breast Lift 2,653 Breast Reduction 3,279 Gynecomastia 423 TOTAL BREAST 12,405 BODY&EXTREMITIESAbdominoplasty 1,808 Buttock Augmentation 220 Buttock Lift 51 Liposuction 3,481 Lower Body Lift 101 Thigh Lift 135 Upper Arm Lift 321 Upper Body Lift 17 Labiaplasty 338 Vaginal Rejuvenation 237 TOTAL BODY&EXTREMITIES 6,709 TOTAL SURGICAL PROCEDURES 37,383INJECTABLESBotulinum Toxin 29,643 Calcium Hydroxylapatite 473 Hyaluronic Acid 12,641 TOTAL INJECTABLES 42,757 TOTAL NON-SURGICAL PROCEDURES 48,486FACIAL REJUVENATIONChemical Peel 1,149 Full Field Ablative 389 Non-Surgical Skin Tightening 3,414 TOTAL FACIAL REJUVENATION 4,952 OTHERCellulite Treatment 456 Hair Removal 0Non-Surgical Fat Reduction 321 TOTAL OTHER 777 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 29,643 61.1%Hyaluronic Acid 12,641 26.1%Non-Surgical Skin Tightening 3,414 7.0%Chemical Peel 1,149 2.4lcium Hydroxylapatite 473 1.0%MOST COMMON PROCEDURES TOTAL%OF TOTALEyelid Surgery 5,864 15.7%Breast Augmentation 4,749 12.7%Liposuction 3,481 9.3t Grafting Face 3,397 9.1%Breast Reduction 3,279 8.8%SOUTH AFRICAINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 36 MALAYSIATOTAL NUMBER OF PROCEDURES IN MALAYSIA 23,923 FACE&HEADBrow Lift 358 Ear Surgery 347 Eyelid Surgery 2,307 Face Lift 482 Facial Bone Contouring 179 Fat Grafting Face 762 Lip Enhancement/Perioral Procedure 437 Neck Lift 392 Rhinoplasty 806 TOTAL FACE&HEAD 6,070 BREASTBreast Augmentation 1,501 Breast Implant Removal 190 Breast Lift 224 Breast Reduction 381 Gynecomastia 314 TOTAL BREAST 2,610 BODY&EXTREMITIESAbdominoplasty 627 Buttock Augmentation 56 Buttock Lift 11 Liposuction 1,490 Lower Body Lift 67 Thigh Lift 101 Upper Arm Lift 123 Upper Body Lift 11 Labiaplasty 112 Vaginal Rejuvenation 56 TOTAL BODY&EXTREMITIES 2,654 TOTAL SURGICAL PROCEDURES 11,334INJECTABLESBotulinum Toxin 4,368 Calcium Hydroxylapatite 0Hyaluronic Acid 2,990 TOTAL INJECTABLES 7,358 TOTAL NON-SURGICAL PROCEDURES 12,589FACIAL REJUVENATIONChemical Peel 202 Full Field Ablative 2,162 Non-Surgical Skin Tightening 1,960 TOTAL FACIAL REJUVENATION 4,323 OTHERCellulite Treatment 45 Hair Removal 358 Non-Surgical Fat Reduction 504 TOTAL OTHER 907 MOST COMMON PROCEDURES TOTAL%OF TOTALBotulinum Toxin 4,368 34.7%Hyaluronic Acid 2,990 23.8%Full Field Ablative 2,162 17.2%Non-Surgical Skin Tightening 1,960 15.6%Non-Surgical Fat Reduction 504 4.0%MOST COMMON PROCEDURES TOTAL%OF TOTALEyelid Surgery 2,307 20.4%Breast Augmentation 1,501 13.2%Liposuction 1,490 13.1%Rhinoplasty 806 7.1t Grafting Face 762 6.7%MALAYSIAINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 37 BANGLADESHTOTAL NUMBER OF PROCEDURES IN BANGLADESH 21,928 FACE&HEADBrow Lift 306 Ear Surgery 966 Eyelid Surgery 1,288 Face Lift 467 Facial Bone Contouring 209 Fat Grafting Face 789 Lip Enhancement/Perioral Procedure 773 Neck Lift 225 Rhinoplasty 1,787 TOTAL FACE&HEAD 6,810 BREASTBreast Augmentation 1,014 Breast Implant Removal 97 Breast Lift 644 Breast Reduction 612 Gynecomastia 1,417 TOTAL BREAST 3,784 BODY&EXTREMITIESAbdominoplasty 1,739 Buttock Augmentation 242 Buttock Lift 48 Liposuction 2,351 Lower Body Lift 145 Thigh Lift 97 Upper Arm Lift 209 Upper Body Lift 32 Labiaplasty 161 Vaginal Rejuvenation 193 TOTAL BODY&EXTREMITIES 5,216 TOTAL SURGICAL PROCEDURES 15,810INJECTABLESBotulinum Toxin 1,159 Calcium Hydroxylapatite0 Hyaluronic Acid 660 TOTAL INJECTABLES 1,819 TOTAL NON-SURGICAL PROCEDURES 6,118FACIAL REJUVENATIONChemical Peel 564 Full Field Ablative 1,240 Non-Surgical Skin Tightening 193 TOTAL FACIAL REJUVENATION 1,996 OTHERCellulite Treatment 161 Hair Removal 2,125 Non-Surgical Fat Reduction 16 TOTAL OTHER 2,302 MOST COMMON PROCEDURES TOTAL%OF TOTALHair Removal 2,125 34.7%Full Field Ablative 1,240 20.3%Botulinum Toxin 1,159 18.9%Hyaluronic Acid 660 10.8%Chemical Peel 564 9.2%MOST COMMON PROCEDURES TOTAL%OF TOTALLiposuction 2,351 14.9%Rhinoplasty 1,787 11.3dominoplasty 1,739 11.0%Gynecomastia 1,417 9.0%Eyelid Surgery(upper and lower lids should be counted as 2 procedures)1,288 8.1NGLADESHINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 38 SURGICAL PROCEDURES BY COUNTRYSURGICAL PROCEDURESWORLDWIDEARGENTINABANGLADESHBELGIUMBRAZILCOLOMBIAFRANCEGERMANYGREECEINDIAIRAN ITALYMALAYSIAMEXICOPERUFACE&HEADBrow Lift386,4279,8133062,07754,1916,2843,20011,4989607,6408,0556,61335824,8339,200Ear Surgery327,99011,1129663,41734,5964,0817,9007,3991,63621,6194,0506,44034712,9455,003Eyelid Surgery1,746,94650,3691,28816,214216,31824,93235,90071,6046,55740,46529,16031,5122,30783,38623,575Face Lift646,48218,2114673,317110,0058,25920,70014,0241,6958,57211,2957,63348231,94210,753Facial Bone Contouring153,7492,59820913419,8452,2221,5001,4501659,1843,1952,78117914,6394,715Fat Grafting Face741,06114,7157893,65284,93113,71121,40014,6753,38234,33417,95512,45276249,86615,525Lip Enhancement/Perioral Procedure901,99147,1667734,456122,78110,70113,70028,0252,61323,46610,26027,20243746,41410,235Neck Lift452,63912,8502252,47975,6246,30611,7009,8511,5618,6928,7305,68539233,0098,050Rhinoplasty1,148,55948,2681,7872,11187,21516,80917,60015,8522,29271,25645,22518,08380660,48944,678Total Face&Head Procedures 6,505,843215,1016,81037,855805,50793,304133,600174,37920,861225,227137,925118,4016,070357,524131,733BREASTBreast Augmentation1,892,77777,8311,01414,271227,45128,60643,80071,4644,97247,69018,58538,9491,501101,26419,665Breast Implant Removal335,93912,323972,94841,3149,4065,5008,4365723,6171,6656,77219016,6672,990Breast Lift903,26624,8446445,997140,67518,17318,30025,8831,94115,28510,44016,24422440,8037,993Breast Reduction686,12519,0626125,39495,25112,46525,10022,6481,68420,50612,2409,74338123,9525,520Gynecomastia352,3027,5791,4171,74246,4634,4305,20011,2831,13242,7196,8855,83931413,7985,175Total Breast Procedures 4,170,409141,6383,78430,351551,15373,08197,900139,71410,301129,81849,81577,5472,610196,48541,343BODY&EXTREMITIESAbdominoplasty1,153,53935,2961,7397,203161,44120,19524,20030,7892,22430,79317,10015,71962771,19712,075Buttock Augmentation771,33315,5752422,580199,25429,5787,6005,0851,2499,22311,7007,2075699,95921,965Buttock Lift110,1672,1864887121,7571,6061,3002,3461669142,1609021112,1601,725Liposuction2,237,96645,5282,35111,491307,28039,74435,50080,5196,463102,29033,84026,6521,490145,26128,118Lower Body Lift128,9982,76614583825,8171,7743,2004,2992414,1212,0251,274678,753115Thigh Lift146,2642,268971,54121,7252,7464,7006,4525064,6211,8453,4661016,695403Upper Arm Lift244,9776,6482091,84336,5153,1226,3008,8767317,3794,4105,94812317,0192,358Upper Body Lift70,3061,4013260313,2728104001,5442472,3252,025339116,188230Labiaplasty189,0585,1681611,37428,4782,7396,9008,1985716,7471,0803,9751126,8091,150Vaginal Rejuvenation84,4952,31119323512,8392,1722,0008243508,333135823564,491863Total Body&Extremities Procedures5,137,101119,1485,21628,576828,377104,48592,100148,93212,749176,74776,32066,3052,654378,53069,000Total Surgical Procedures15,813,353475,88715,81096,7822,185,038270,870323,600463,02643,911531,792264,060262,25411,334932,539242,075Note:Results for individual countries are limited to those that received a sufficient sample of participants.INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 39 SURGICAL PROCEDURES BY COUNTRYSURGICAL PROCEDURESROMANIASOUTH AFRICASPAINSYRIATHAILANDTURKIYEUKUSVENEZUELAFACE&HEADBrow Lift2,5335075,4302,0405,89519,3222,01531,0975,510Ear Surgery2,3136427,7751,0002,58211,3414,84631,5543,843Eyelid Surgery8,6115,86440,2526,90027,35761,07515,186122,09220,373Face Lift2,5972,4516,2692,2407,65719,4578,47694,1589,063Facial Bone Contouring630171,8215302,9546,45144116,313580Fat Grafting Face4,3753,39711,9463,9708,08333,0982,28025,85012,180Lip Enhancement/Perioral Procedure10,2672,33220,1784,1703,41623,8187,734108,5007,540Neck Lift1,3891,3525,0252,4505,01812,0535,13142,5265,655Rhinoplasty8,1881,70713,5666,25017,88583,1468,63749,0786,090Total Face&Head Procedures 40,90218,269112,26229,55080,849269,76154,745521,16770,833BREASTBreast Augmentation18,3474,74944,6633,87015,32153,80031,542242,59621,315Breast Implant Removal1,2001,3017,1454902,3516,2035,56574,1095,873Breast Lift7,5612,65318,8591,8905,43629,56612,697151,90213,268Breast Reduction3,6953,27912,8471,6303,65829,07413,18877,8566,960Gynecomastia1,8374235,4181,3101,54215,2713,35521,4182,320Total Breast Procedures 32,63912,40588,9319,19028,307133,91466,347567,88149,735BODY&EXTREMITIESAbdominoplasty5,4491,80812,3193,6505,87836,40911,425193,43915,878Buttock Augmentation1,5372207,5162,7801,79417,3301,87523,6619,643Buttock Lift566513644307532,48323113,1313,915Liposuction6,8673,48125,4816,24011,92767,96218,831383,91920,300Lower Body Lift8631019508001,2464,04561913,8861,885Thigh Lift1,2691352,2717508906,0921,28513,9751,885Upper Arm Lift9363212,6621,1501,9837,5491,82928,3981,595Upper Body Lift642171983407432,0895049,7391,305Labiaplasty1,7713385,2264701,0633,5823,62518,3162,538Vaginal Rejuvenation9892371,2924407421,906763,589798Total Body&Extremities Procedures20,8906,70958,27917,05027,019149,44740,300702,05459,740Total Surgical Procedures94,43137,383259,47355,790136,174553,122161,3921,791,102180,308Note:Results for individual countries are limited to those that received a sufficient sample of participants.INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 40 NON-SURGICAL PROCEDURES BY COUNTRYNON-SURGICAL PROCEDURESWORLDWIDEARGENTINABANGLADESHBELGIUMBRAZILCOLOMBIAFRANCEGERMANYGREECEINDIAIRAN ITALYMALAYSIAINJECTABLESBotulinum Toxin8,877,991208,2771,15966,129571,11774,653208,900421,68446,087115,19489,609194,3354,368Calcium Hydroxyapatite344,62419,70801,74247,8837,89910,30013,61865725025212,4680Hyaluronic Acid 5,564,866233,25066041,105429,39143,230234,900286,28548,954107,10035,955190,6062,990Total Injectables Procedures 14,787,481461,2351,819108,9761,048,391125,782454,100721,58795,698222,544125,816397,4097,358FACIAL REJUVENATIONChemical Peel553,7855,29056487118,8329989,0004,3853,04870,1984422,442202Full Field Ablative437,65219,2991,2401,74231,0012,3713,8009,2834,80424,0753,29511,1792,162Non-Surgical Skin Tightening831,58323,5041933,68525,14010,87819,70023,2774,53845,4635,99214,9821,960Total Facial Rejuvenation Procedures 1,823,02048,0941,9966,29874,97314,24832,50036,94612,389139,7369,33148,6034,323OTHERCellulite Treatment331,98141,3481612,81441,7703,4624,8001,1854,2993,4953,45913,78745Hair Removal1,608,447133,1662,1256,33216,41228,28860,0004,41535,14897,6013,61426,296358Non-Surgical Fat Reduction631,21250,486162,21114,9674,6198,70017,3073,41233,5551,3749,093504Total Other Procedures 2,571,640 225,000 2,302 11,357 73,149 36,369 73,500 22,907 42,858 134,651 8,447 49,176 907 Total Non-Surgical Procedures 19,182,141734,3296,118126,6301,196,513176,399560,100781,440150,945496,931143,593495,18812,589Note:Results for individual countries are limited to those that received a sufficient sample of participants.TOTAL PROCEDURES34,995,4941,210,21621,928223,4123,381,551447,268883,7001,244,466194,8561,028,723407,653757,44223,923INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 41 NON-SURGICAL PROCEDURES BY COUNTRYNON-SURGICAL PROCEDURESMEXICOPERUROMANIASOUTH AFRICASPAINSYRIATHAILANDTURKIYEUKUSVENEZUELAINJECTABLESBotulinum Toxin372,06487,45886,68629,64389,18637,53027,835396,62530,8352,499,85971,413Calcium Hydroxyapatite10,9442,9901,9564738,36430005,80055484,8175,365Hyaluronic Acid 204,92650,42872,38012,641114,20026,2704,250182,08028,680712,22529,943Total Injectables Procedures 587,934140,875161,02242,757211,75064,10032,086584,50560,0703,296,901106,720FACIAL REJUVENATIONChemical Peel16,2241,9553,5811,1497,9751,5709923,636719232,9022,610Full Field Ablative14,8167,3603,1003898,9212,1201745,331284118,6615,873Non-Surgical Skin Tightening37,3814,3702,2953,4148,8213,3001,96721,0661,137261,08817,618Total Facial Rejuvenation Procedures 68,42113,6858,9764,95225,7176,9903,13330,0332,139612,65126,100OTHERCellulite Treatment32,5631,1509314567,2271,0702272,37815322,2178,990Hair Removal58,69713,2252,742018,99223,46057717,057424240,37329,943Non-Surgical Fat Reduction34,7995,5781,0703215,4491,63064314,045344233,45810,223Total Other Procedures 126,058 19,953 4,743 777 31,668 26,160 1,447 33,479 922 496,047 49,155 Total Non-Surgical Procedures 782,413174,513174,74248,486269,13697,25036,666648,01863,1304,405,599181,975TOTAL PROCEDURES1,714,952416,588269,17385,869528,608153,040172,8401,201,139224,5236,196,701362,283Note:Results for individual countries are limited to those that received a sufficient sample of participants.INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 42 RANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1US242,59612.8+razil227,45112.0%3Mexico101,2645.4Jrgentina77,8314.1%5Germany71,4643.8%6Turkiye53,8002.8%7India47,6902.5%8Spain44,6632.4rance43,8002.3Italy38,9492.1%BREAST AUGMENTATION*Rankings are based solely on those countries from which a sufficient survey response was received and data were considered to be representative.RANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1US383,91917.2+razil307,28013.7%3Mexico145,2616.5%4India102,2904.6%5Germany80,5193.6%6Turkiye67,9623.0zrgentina45,5282.0olombia39,7441.8rance35,5001.6Iran33,8401.5%LIPOSUCTIONRANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1Brazil216,31812.4%2US122,0927.0%3Mexico83,3864.8%4Germany71,6044.1%5Turkiye61,0753.5jrgentina50,3692.9%7India40,4652.3%8Spain40,2522.3rance35,9002.1Italy31,5121.8%EYELID SURGERYRANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1Brazil87,2157.6%2Turkiye83,1467.2%3India71,2566.2%4Mexico60,4895.3%5US49,0784.3jrgentina48,2684.2%7Iran45,2253.9%8Peru44,6783.9%9Italy18,0831.6Thailand17,8851.6%RHINOPLASTYRANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1US193,43916.8+razil161,44114.0%3Mexico71,1976.2%4Turkiye36,4093.2Zrgentina35,2963.1%6India30,7932.7%7Germany30,7892.7rance24,2002.1olombia20,1951.8Iran17,1001.5DOMINOPLASTYCOUNTRIES PERFORMING THE MOST POPULAR SURGICAL PROCEDURESINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 43 RANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1US2,499,85928.2+razil571,1176.4%3Germany421,6844.7%4Turkiye396,6254.5%5Mexico372,0644.2orance208,9002.4zrgentina208,2772.3%8Italy194,3352.2%9India115,1941.3Iran89,6091.0%BOTULINUM TOXIN*Rankings are based solely on those countries from which a sufficient survey response was received and data were considered to be representative.RANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1US712,22512.8+razil429,3917.7%3Germany286,2855.1Orance234,9004.2Zrgentina233,2504.2%6Mexico204,9263.7%7Italy190,6063.4%8Turkiye182,0803.3%9Spain114,2002.1India107,1001.9%HYALURONIC ACIDRANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1US240,37314.9*rgentina133,1668.3%3India97,6016.1Orance60,0003.7%5Mexico58,6973.6%6Greece35,1482.2%7Venezuela29,9431.9olombia28,2881.8%9Italy26,2961.6Syria23,4601.5%HAIR REMOVALRANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1US261,08831.4%2India45,4635.5%3Mexico37,3814.5Krazil25,1403.0Zrgentina23,5042.8%6Germany23,2772.8%7Turkiye21,0662.5rance19,7002.4%9Venezuela17,6182.1Italy14,9821.8%NON-SURGICAL SKIN TIGHTENINGRANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1US233,45837.0*rgentina50,4868.0%3Mexico34,7995.5%4India33,5555.3%5Germany17,3072.7krazil14,9672.4%7Turkiye14,0452.2%8Venezuela10,2231.6%9Italy9,0931.4France8,7001.4%NON-SURGICAL FAT REDUCTIONCOUNTRIES PERFORMING THE MOST POPULAR NON-SURGICAL PROCEDURESINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 44 SURGICAL TOTALS RANKED BY CATEGORYRANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1Brazil805,50712.4%2US521,1678.0%3Mexico357,5245.5%4Turkiye269,7614.1%5India225,2273.5jrgentina215,1013.3%7Germany174,3792.7%8Iran137,9252.1rance133,6002.1Peru131,7332.0CE&HEADRANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1US567,88113.6+razil551,15313.2%3Mexico196,4854.7Jrgentina141,6383.4%5Germany139,7143.4%6Turkiye133,9143.2%7India129,8183.1rance97,9002.3%9Spain88,9312.1Italy77,5471.9%RANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1Brazil828,37716.1%2US702,05413.7%3Mexico378,5307.4%4India176,7473.4%5Turkiye149,4472.9%6Germany148,9322.9zrgentina119,1482.3olombia104,4852.0rance92,1001.8Iran76,3201.5%BREAST BODY&EXTREMITIES*Rankings are based solely on those countries from which a sufficient survey response was received and data were considered to be representative.INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 45 NON-SURGICAL TOTALS RANKED BY CATEGORYRANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1US3,296,90122.3+razil1,048,3917.1%3Germany721,5874.9%4Mexico587,9344.0%5Turkiye584,5054.0jrgentina461,2353.1rance454,1003.1%8Italy397,4092.7%9India222,5441.5Spain211,7501.4%INJECTABLESRANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1US612,65133.6%2India139,7367.7;razil74,9734.1%4Mexico68,4213.8%5Italy48,6032.7jrgentina48,0942.6%7Germany36,9462.0rance32,5001.8%9Turkiye30,0331.6Venezuela26,1001.4%RANK*COUNTRYNUMBER OF PROCEDURESPERCENTAGEOF TOTAL1US496,04719.3*rgentina225,0008.7%3India134,6515.2%4Mexico126,0584.9_rance73,5002.9krazil73,1492.8%7Italy49,1761.9%8Venezuela49,1551.9%9Greece42,8581.7Colombia36,3691.4CIAL REJUVENATION OTHER*Rankings are based solely on those countries from which a sufficient survey response was received and data were considered to be representative.INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 46 COUNTRIES RANKED BY TOTAL NUMBER OF PROCEDURESRANK*COUNTRYTOTAL SURGICAL PROCEDURESPERCENTAGE OF TOTAL SURGICAL PROCEDURESTOTAL NON-SURGICAL PROCEDURESPERCENTAGE OF TOTAL NON-SURGICAL PROCEDURESNUMBER OF PROCEDURESPERCENTAGE OF TOTAL1US1,791,10211.3%4,405,59923.0%6,196,70117.7+razil2,185,03813.8%1,196,5136.2%3,381,5519.7%3Mexico932,5395.9x2,4134.1%1,714,9524.9%4Germany463,0262.9x1,4404.1%1,244,4663.6Zrgentina475,8873.0s4,3293.8%1,210,2163.5%6Turkiye553,1223.5d8,0183.4%1,201,1393.4%7India531,7923.4I6,9312.6%1,028,7232.9rance323,6002.0V0,1002.93,7002.5%9Italy262,2541.7I5,1882.6u7,4422.2Spain259,4731.6&9,1361.4R8,6081.5%*Rankings are based solely on those countries from which a sufficient survey response was received and data were considered to be representative.COUNTRIES RANKED BY TOTAL NUMBER OF PROCEDURESTOP 10INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 47 RANK COUNTRYNUMBER OF SURGEONS%OF TOTAL1US7,75014.1+razil6,45711.7%3Japan3,0505.5Lhina3,0005.4%5India3,0005.4%6Korea,Republic of(South Korea)2,7395.0zrgentina2,5004.5%8Mexico2,3944.3%9Russia2,0003.6Turkiye1,6002.9Germany1,5502.8Egypt1,4502.6Italy1,1512.1France1,0001.8Spain1,0001.8%COUNTRIES RANKED BY ESTIMATEDNUMBER OF PLASTIC SURGEONSRANK COUNTRYNUMBER OF SURGEONS%OF TOTAL16Colombia8251.5Taiwan7501.4Venezuela7251.3UK7171.3 Netherlands6001.1!Peru5751.0Thailand5000.9#Canada4500.8$Iran4500.8%Australia4240.8&Saudi Arabia4200.8Romania3500.6(Ukraine3500.6)Belgium3350.60Switzerland3130.6%COUNTRIES RANKED BY ESTIMATED NUMBEROF PLASTIC SURGEONSTOP 30INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 48 SURGICAL PROCEDURE GROUP RANKING BY COUNTRYRANKTOTAL%OF TOTALBRAZIL1Total Body&Extremities Procedures828,37737.9%2Total Face&Head Procedures805,50736.9%3Total Breast Procedures551,15325.2%US1Total Body&Extremities Procedures702,05439.2%2Total Breast Procedures567,88131.7%3Total Face&Head Procedures521,16729.1%MEXICO1Total Body&Extremities Procedures378,53040.6%2Total Face&Head Procedures357,52438.3%3Total Breast Procedures196,48521.1%TURKIYE1Total Face&Head Procedures269,76148.8%2Total Body&Extremities Procedures149,44727.0%3Total Breast Procedures133,91424.2%INDIA1Total Face&Head Procedures225,22742.4%2Total Body&Extremities Procedures176,74733.2%3Total Breast Procedures129,81824.4%RANKTOTAL%OF TOTALARGENTINA1Total Face&Head Procedures215,10145.2%2Total Breast Procedures141,63829.8%3Total Body&Extremities Procedures119,14825.0%GERMANY1Total Face&Head Procedures174,37937.7%2Total Body&Extremities Procedures148,93232.2%3Total Breast Procedures139,71430.2%FRANCE1Total Face&Head Procedures133,60041.3%2Total Breast Procedures97,90030.3%3Total Body&Extremities Procedures92,10028.5%COLOMBIA1Total Body&Extremities Procedures104,48538.6%2Total Face&Head Procedures93,30434.4%3Total Breast Procedures73,08127.0%IRAN1Total Face&Head Procedures137,92552.2%2Total Body&Extremities Procedures76,32028.9%3Total Breast Procedures49,81518.9%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 49 NON-SURGICAL PROCEDURE GROUP RANKING BY COUNTRYRANKTOTAL%OF TOTALUS1 Total Injectables Procedures 3,296,90174.8%2 Total Facial Rejuvenation Procedures 612,65113.9%3 Total Other Procedures 496,04711.3%BRAZIL1 Total Injectables Procedures 1,048,39187.6%2 Total Facial Rejuvenation Procedures 74,9736.3%3 Total Other Procedures 73,1496.1%MEXICO1 Total Injectables Procedures 587,93475.1%2 Total Other Procedures 126,05816.1%3 Total Facial Rejuvenation Procedures 68,4218.7%GERMANY1 Total Injectables Procedures 721,58792.3%2 Total Facial Rejuvenation Procedures 36,9464.7%3 Total Other Procedures 22,9072.9%ARGENTINA1 Total Injectables Procedures 461,23562.8%2 Total Other Procedures 225,00030.6%3 Total Facial Rejuvenation Procedures 48,0946.5%RANKTOTAL%OF TOTALTURKIYE1 Total Injectables Procedures 584,50590.2%2 Total Other Procedures 33,4795.2%3 Total Facial Rejuvenation Procedures 30,0334.6%FRANCE1 Total Injectables Procedures 454,10081.1%2 Total Other Procedures 73,50013.1%3 Total Facial Rejuvenation Procedures 32,5005.8%INDIA1 Total Injectables Procedures 222,54444.8%2 Total Facial Rejuvenation Procedures 139,73628.1%3 Total Other Procedures 134,65127.1%ITALY1 Total Injectables Procedures 397,40980.3%2 Total Other Procedures 49,1769.9%3 Total Facial Rejuvenation Procedures 48,6039.8%SPAIN1 Total Injectables Procedures 211,75078.7%2 Total Other Procedures 31,66811.8%3 Total Facial Rejuvenation Procedures 25,7179.6%IN 2023PROCEDURES PERFORMED BYPLASTIC SURGEONSINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 51 NUMBER OF WORLDWIDE SURGICAL PROCEDURES PERFORMED BY PLASTIC SURGEONSRANKSURGICAL PROCEDURESTOTALPERCENTAGE OF TOTAL SURGICAL PROCEDURES1Liposuction2,237,96614.2+reast Augmentation1,892,77712.0yelid Surgery1,746,94611.0Jbdominoplasty1,153,5397.3%5Rhinoplasty1,148,5597.3kreast Lift903,2665.7%7Lip Enhancement/Perioral Procedure901,9915.7uttock Augmentation771,3334.9at Grafting Face741,0614.7Breast Reduction686,1254.3Face Lift646,4824.1Neck Lift452,6392.9Brow Lift386,4272.4Gynecomastia352,3022.2Breast Implant Removal335,9392.1Ear Surgery327,9902.1Upper Arm Lift244,9771.5Labiaplasty189,0581.2Facial Bone Contouring153,7491.0 Thigh Lift146,2640.9!Lower Body Lift128,9980.8Buttock Lift110,1670.7#Vaginal Rejuvenation84,4950.5$Upper Body Lift70,3060.4%Total Surgical Procedures15,813,353INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 52 NUMBER OF WORLDWIDE NON-SURGICAL PROCEDURES PERFORMED BY PLASTIC SURGEONSRANKNON-SURGICAL PROCEDURESTOTALPERCENTAGE OF TOTAL NON-SURGICAL PROCEDURES1Botulinum Toxin8,877,99146.3%2Hyaluronic Acid5,564,86629.0%3Hair Removal1,608,4478.4%4Non-Surgical Skin Tightening831,5834.3%5Non-Surgical Fat Reduction631,2123.3lhemical Peel553,7852.9ull Field Ablative437,6522.3alcium Hydroxylapatite344,6241.8ellulite Treatment331,9811.7%Total Non-Surgical Procedures 19,182,141INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 53 PERCENTAGE OF PLASTIC SURGEONS PERFORMING EACH SURGICAL PROCEDURE SURGICAL PROCEDURESWORLDWIDEARGENTINABANGLADESHBELGIUMBRAZILCOLOMBIAFRANCEGERMANYGREECEINDIAIRAN ITALYMALAYSIAFACE&HEADBrow Lift67.3V.0B.2e.4v.2h.8P.8u.8.7W.6.9.5S.6r Surgery77.5.0.7.5.0 x.1.8Q.5.9u.8.7v.7P.0%Eyelid Surgery94.00.0.9.2.2.9.6.0.4.00.0.7.1ce Lift75.1h.0B.2i.2.7.6.2x.8.9f.7.3b.8S.6cial Bone Contouring34.7(.0.2%7.73.3C.8.0!.2.7Q.5x.6%.6%.0t Grafting Face75.2h.0h.9e.4v.2q.9.0f.7.70.0.3r.1u.0%Lip Enhancement/Perioral Procedure65.9v.0d.4a.5a.9V.2T.2.6u.0c.6.1e.1P.0%Neck Lift65.3H.0&.7a.5R.4.4b.7.6.9W.6x.6H.8F.4%Hair Transplantation14.9%4.0&.7%3.8%9.5.60.5%9.1%.0f.7%3.6%7.0.9%Rhinoplasty76.1.0.7F.2f.7.4b.79.4.7.00.0y.1q.4%BREASTBreast Augmentation Saline3.1.0%0.0%0.0%0.0%3.1%1.7%0.0%3.6%0.0%0.0%4.6%3.6%Breast Augmentation Silicone90.6.0.0.2.2.9.3.0.4.9.4.7q.4%Breast Augmentation Fat Transfer55.8.01.1.6R.4b.5t.6u.8g.9f.7.7S.5W.1%Breast Implant Removal79.8v.03.3.2.0.8.8.8.1T.6.1r.1d.3%Breast Lift85.6.0F.7.3.5.8.9.9.3f.7.4.7F.4%Breast Reduction87.2h.0s.3.2.50.0.2.9.9.8.4.4u.0%Gynecomastia81.1r.0.3.8.5.4.0.8.9.0.4.7u.0%PERCENTAGE OF PLASTIC SURGEONS PERFORMING EACH SURGICAL PROCEDURE INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 54 PERCENTAGE OF PLASTIC SURGEONS PERFORMING EACH SURGICAL PROCEDURE SURGICAL PROCEDURESMEXICOPERUROMANIASOUTH AFRICASPAINSYRIATHAILANDTURKIYEUKUSVENEZUELAFACE&HEADBrow Lift79.8.5P.0T.2p.8.2y.0y.4.6q.6d.3r Surgery78.5.7q.4f.7.6.6R.6.4q.9A.1q.4%Eyelid Surgery98.70.0.7.7.80.0.8.2.5.10.0ce Lift86.1.5W.1X.3V.2.7e.8p.6Y.4w.50.0cial Bone Contouring58.2s.7(.6%8.3.9Y.1R.6R.9.87.3(.6t Grafting Face78.50.0W.1p.8h.8.2q.0v.57.5t.9.7%Lip Enhancement/Perioral Procedure82.3.2q.4A.7d.6.6R.6U.91.2g.40.0%Neck Lift84.8.2B.9E.8R.1.7e.8a.8S.1s.3x.6%Hair Transplantation8.9.8%0.0%0.0%8.3.3.5.6%3.1$.7%0.0%Rhinoplasty93.70.0 x.6X.3y.2.7y.0v.5P.0p.4x.6%BREASTBreast Augmentation Saline3.8.5%0.0%0.0%2.1%6.8%0.0%0.0%6.2%.8%0.0%Breast Augmentation Silicone96.2.2.9.8.80.0.8.30.0s.00.0%Breast Augmentation Fat Transfer63.3s.75.7A.7E.8c.61.6D.1C.8.1d.3%Breast Implant Removal94.9.7q.4y.2.7.4h.4g.6.6.10.0%Breast Lift94.9.5.9.8.9.7e.8s.5.8.30.0%Breast Reduction92.4.7.70.0.7.4e.8.30.0v.3.7%Gynecomastia79.8.5q.4f.7.6.2G.4s.5h.8W.9d.3%PERCENTAGE OF PLASTIC SURGEONS PERFORMING EACH SURGICAL PROCEDURE INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 55 PERCENTAGE OF PLASTIC SURGEONS PERFORMING EACH SURGICAL PROCEDURE SURGICAL PROCEDURESWORLDWIDEARGENTINABANGLADESHBELGIUMBRAZILCOLOMBIAFRANCEGERMANYGREECEINDIAIRAN ITALYMALAYSIABODY&EXTREMITIESAbdominoplasty90.8.0.1.2.5.8.2.9.3.9.4.0.9%Buttock AugmentationImplants only19.62.0%4.4%3.83.37.5.2.2%3.6%9.19.3%9.3%0.0%Buttock Augmentation Fat Transfer53.6h.0.84.6.0.6T.26.4F.4B.4.74.9.3%Buttock Augmentation Injectables11.6%0.0%2.2%7.7#.8.5.0%9.1.9%3.0%0.0.9%3.6%Buttock Lift28.1.0.1#.1R.41.2.0$.22.1.2W.1.6%7.1%Liposuction89.9.0w.80.0.5.9.2.9.3.90.0.70.0%Lower Body Lift32.5%8.0 .0&.9G.6(.17.3.35.73.3W.1.9.9%Penile Enlargement10.9%4.0(.9.4%9.5%3.1#.7.2.7%9.1%0.0.6%7.1%Thigh Lift50.0$.0 .0e.4a.9b.5b.7T.6.76.4u.07.2(.6%Upper Arm Lift65.0.0$.4s.1q.4.4v.3x.8u.0T.6x.6b.85.7%Upper Body Lift21.2%8.0%8.9.28.1(.1.0!.2!.4.39.3.6.3%Labiaplasty55.0D.07.8e.4R.4e.6b.7E.4P.0Q.5B.9b.8F.4%Vaginal Rejuvenation22.7.03.3.58.1.6.0%6.1.7T.6.7%9.3.9%PERCENTAGE OF PLASTIC SURGEONS PERFORMING EACH SURGICAL PROCEDURE INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 56 PERCENTAGE OF PLASTIC SURGEONS PERFORMING EACH SURGICAL PROCEDURE SURGICAL PROCEDURESMEXICOPERUROMANIASOUTH AFRICASPAINSYRIATHAILANDTURKIYEUKUSVENEZUELABODY&EXTREMITIESAbdominoplasty98.7.2x.6.8.8.7s.7.4.8.7.7%Buttock AugmentationImplants only41.8W.9%7.1%4.2).2R.3!.0%5.9%0.0.0!.4%Buttock Augmentation Fat Transfer92.4.2(.6%.0T.2.2).0G.1.5D.7.7%Buttock Augmentation Injectables6.3!.0.3%0.0.4).6%2.6%2.9%6.2.0.3%Buttock Lift46.8!.0!.4%8.3.4w.3!.0&.5.60.1(.6%Liposuction100.0.5q.4.7.8.7v.3v.5.4.50.0%Lower Body Lift41.8.5!.4 .8.9w.31.68.2%.0C.1!.4%Penile Enlargement7.6.85.7%0.0.5 .4.2%2.9%3.1%5.3%0.0%Thigh Lift49.4.85.7).2V.2.41.6X.8F.9.65.7%Upper Arm Lift83.5s.75.7P.0f.7.9B.1a.8Y.4d.15.7%Upper Body Lift36.7.8%7.1%4.2%8.3E.4.2).4!.9%.4.3%Labiaplasty50.6c.2W.1A.7u.0a.49.5P.0q.96.6P.0%Vaginal Rejuvenation20.2B.15.7.7.7.9.2&.5%6.2.2!.4%PERCENTAGE OF PLASTIC SURGEONS PERFORMING EACH SURGICAL PROCEDURE INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 57 PERCENTAGE OF PLASTIC SURGEONS PERFORMINGEACH NON-SURGICAL PROCEDUREPERCENTAGE OF ALL PLASTIC SURGEONS PERFORMING EACH NON-SURGICAL PROCEDURENON-SURGICAL PROCEDURESWORLDWIDEARGENTINABANGLADESHBELGIUMBRAZILCOLOMBIAFRANCEGERMANYGREECEINDIAIRAN ITALYMALAYSIAINJECTABLES FACEBotulinum Toxin84.7.0F.7.2.5.40.0.00.0.9.4.0S.6lcium Hydroxylapatite19.8$.0%0.0&.93.3C.8E.8.2.3%0.0%7.12.6%3.6%Hyaluronic Acid75.1v.0$.4.6f.7x.10.0.90.0c.6x.6.45.7%Poly-L-Lactic Acid13.8%8.0%2.2.5B.9.6.0.2(.6%0.0%3.62.6.7%Polymethylmethacrylate0.7%0.0%2.2%0.0%0.0%0.0%0.0%3.0%0.0%0.0%0.0%0.0%0.0%INJECTABLES BODYHyaluronic Acid17.6%4.0%4.4.4.0.8.0!.22.1.2.34.9%7.1%Polymethylmethacrylate0.5%0.0%2.2%0.0%4.8%0.0%0.0%3.0%0.0%0.0%0.0%0.0%3.6CIAL REJUVENATIONChemical Peel24.9.03.3.2(.6.5I.2$.2F.4Q.5%3.69.5.9%Full Field Ablative23.1$.0.2#.1#.8.5.2$.2d.30.32.19.55.7rmabrasion12.8%8.0.8%3.8%9.5%9.4.6.1.3.2.9%7.0.7%Microdermabrasion12.4%4.03.3%3.8.0%9.4%5.1.2%.0.2.3%7.0.9%Non-Surgical Skin Tightening26.0.0.3#.1.3.62.2$.2%.0B.4%.0 .92.1%Photo Rejuvenation10.5.0%6.7#.1%9.5%9.4.2%0.0%.0%9.1%3.6.3%7.1%OTHERCellulite Treatment15.8.0%8.9%3.8#.8.8.6%9.15.7.2.7#.3%3.6%Hair Removal18.6.05.6.4%9.5%3.1(.8%6.1.7Q.5%3.6.02.1%Non-Surgical Fat Reduction19.2.0%4.4.4.3.6(.80.3%.0$.2.3#.3.9%Tattoo Removal17.4%8.0s.3%0.0%0.0%9.4%8.5%9.1!.4c.6.7%.6(.6%Treatment of Leg Veins7.2%8.0 .0.2%0.0%0.0%1.7%6.1.9.3%0.0.6%3.6%Sclerotherapy7.2%0.0.2%0.0%0.0%3.1%0.0%6.12.10.3%3.6%2.3%0.0%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 58 PERCENTAGE OF PLASTIC SURGEONS PERFORMINGEACH NON-SURGICAL PROCEDUREPERCENTAGE OF ALL PLASTIC SURGEONS PERFORMING EACH NON-SURGICAL PROCEDURENON-SURGICAL PROCEDURESMEXICOPERUROMANIASOUTH AFRICASPAINSYRIATHAILANDTURKIYEUKUSVENEZUELAINJECTABLES FACEBotulinum Toxin98.7.50.0.7d.6.2e.8.2e.6.80.0lcium Hydroxylapatite19.0.5.3.77.5.7%2.6%5.9%0.0#.7(.6%Hyaluronic Acid87.3.7.9u.0f.7.41.6v.5C.8.90.0%Poly-L-Lactic Acid13.9%5.3B.9).2.5.9%0.0%5.9%3.1 .6!.4%Polymethylmethacrylate0.0%0.0%0.0%0.0%0.0%2.3%0.0%0.0%0.0%9.0%0.0%INJECTABLES BODYHyaluronic Acid7.6!.0!.4%4.2.6E.4%2.6%8.8!.9%8.1!.4%Polymethylmethacrylate0.0%0.0%0.0%0.0%0.0%2.3%0.0%0.0%0.0%0.3%0.0CIAL REJUVENATIONChemical Peel21.5.5.33.37.5).6%5.3.7%9.47.05.7%Full Field Ablative16.5.85.7%4.2.1P.0%5.3%8.8%6.2G.0(.6rmabrasion12.7&.3%0.0%8.3.5%.0%5.3 .6%3.1#.8!.4%Microdermabrasion20.2.8%0.0%4.2%8.3.3%0.0.6%0.0.8(.6%Non-Surgical Skin Tightening30.4&.3.3 .8%.0R.3.8).4%9.4R.6!.4%Photo Rejuvenation8.9.5%0.0%8.3.6.4%7.9%2.9%0.08.5!.4%OTHERCellulite Treatment30.4.5%7.1%4.2).21.8%5.3%5.9%3.1.1B.9%Hair Removal17.7.8%0.0%0.0.7P.0.2%2.9%0.0).5(.6%Non-Surgical Fat Reduction26.6.8.3%4.2.7C.2.5.6%3.1B.55.7%Tattoo Removal10.1.8%7.1%0.0%4.2R.3%5.3%5.9%6.2%9.7!.4%Treatment of Leg Veins3.8%0.0%0.0%0.0.4.9%7.9%0.0%0.0.2%7.1%Sclerotherapy5.1%0.0%0.0%4.2.6%9.1%5.3%0.0%0.0.4%0.0MOGRAPHICSINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 60 GENDER DISTRIBUTION FOR COSMETIC PROCEDURES SURGICALRANK FEMALENUMBER OF PROCEDURESPERCENTAGE OF TOTAL1 Liposuction 1,898,88084.8%2 Breast Augmentation 1,868,36098.7%3 Eyelid Surgery 1,353,56677.5%4 Abdominoplasty 1,033,26489.6%5 Breast Lift 903,266100.0%6 Rhinoplasty 858,06774.7%7Lip Enhancement/Perioral Procedure 805,34989.3uttock Augmentation Implants and Fat Transfer 758,99198.4%9 Breast Reduction 686,125100.0 Fat Grafting Face 613,29282.8 Face Lift 543,86584.1 Neck Lift 368,64481.4 Breast Implant Removal 330,24598.3 Brow Lift 311,93580.7 Upper Arm Lift 225,37992.0 Ear Surgery 207,40563.2 Labiaplasty 189,058100.0 Thigh Lift 132,10990.3 Facial Bone Contouring 112,74973.3 Lower Body Lift 107,49883.3! Buttock Lift 104,92195.2 Vaginal Rejuvenation 84,495100.0# Upper Body Lift 59,48984.6%Total Surgical Procedures13,556,95585.7%GENDER DISTRIBUTION FOR SURGICAL COSMETIC PROCEDURESRANKMALENUMBER OF PROCEDURESPERCENTAGE OF TOTAL1 Eyelid Surgery 393,38022.5%2 Gynecomastia 352,302100.0%3 Liposuction 339,08615.2%4 Rhinoplasty 290,49225.3%5 Fat Grafting Face 127,76917.2%6 Ear Surgery 120,58436.8%7 Abdominoplasty 120,27410.4%8 Face Lift 102,61615.9%9Lip Enhancement/Perioral Procedure 96,64210.7 Neck Lift 83,99518.6 Brow Lift 74,49219.3 Facial Bone Contouring 41,00026.7 Breast Augmentation 24,4171.3 Lower Body Lift 21,50016.7 Upper Arm Lift 19,5988.0 Thigh Lift 14,1559.7 Buttock Augmentation 12,3411.6 Upper Body Lift 10,81615.4 Breast Implant Removal 5,6941.7 Buttock Lift 5,2464.8%Total Surgical Procedures2,256,39814.3%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 61 GENDER DISTRIBUTION FOR COSMETIC PROCEDURES NON-SURGICAL RANKFEMALENUMBER OF PROCEDURESPERCENTAGE OF TOTAL1Botulinum Toxin 7,526,99384.8%2Hyaluronic Acid 4,894,10187.9%3Hair Removal 1,305,86881.2%4Non-Surgical Skin Tightening 695,93583.7%5Non-Surgical Fat Reduction 501,51179.5lhemical Peel 486,65987.9ull Field Ablative 348,01279.5ellulite Treatment 313,18994.3alcium Hydroxylapatite 291,60584.6%Total Non-Surgical Procedures16,363,87485.3%Total Procedures29,920,82885.5%GENDER DISTRIBUTION FOR NON-SURGICAL COSMETIC PROCEDURESRANKMALENUMBER OF PROCEDURESPERCENTAGE OF TOTAL1Botulinum Toxin 1,350,99915.2%2Hyaluronic Acid 670,76512.1%3Hair Removal 302,57918.8%4Non-Surgical Skin Tightening 135,64816.3%5Non-Surgical Fat Reduction 129,70120.5oull Field Ablative 89,64020.5|hemical Peel 67,12512.1alcium Hydroxylapatite 53,01915.4ellulite Treatment 18,7915.7%Total Non-Surgical Procedures 2,818,26814.7%Total Procedures5,074,66614.5%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 62 PATIENT AGE RELATED TO COSMETIC PROCEDURES 17 YEARSOLD OR YOUNGER1834 YEARSOLD3550 YEARSOLD5164 YEARSOLD65 YEARSOR OLDERBreast Augmentations 18,928 1.0%1,016,421 53.7p0,328 37.00,066 7.4,035 0.9%Liposuction 26,856 1.29,039 43.34,563 43.1%5,128 11.4,380 1.0%Rhinoplasty 47,091 4.1u5,752 65.8(8,288 25.1P,537 4.4%6,891 0.6%Botulinum Toxin 62,146 0.7%2,130,718 24.0%4,350,216 49.0%1,970,914 22.263,998 4.1%Non-Surgical Fat Reduction 8,206 1.3%9,428 41.1&6,372 42.2,058 13.0,149 2.4%AGE DISTRIBUTION OF PATIENTS UNDERTAKING CERTAIN COSMETIC PROCEDURESCOUNTRYPERCENTAGE OF SURGEONS PERFORMING BREAST AUGMENTATION IN MINORSWorldwide7.6%Peru26.7%Brazil26.0%France19.3%Mexico15.5%Romania14.3%Colombia13.3%Iran12.5lgium7.7%Turkiye6.7%US5.3%Italy5.0%Spain4.6%South Africa4.4%Germany4.3%Argentina4.2%India3.1ngladesh2.4%PERCENTAGE OF SURGEONS PERFORMING BREAST AUGMENTATION IN WOMEN OF 17 YEARS OLD OR YOUNGER(showing only countries with percentage 0%)REASONS FOR PROCEDURETubular Breast30.7%Severe Asymmetry20.1%Congenital Micromastia18.2%Purely Cosmetic Bilateral Augmentation13.4%Congenital Absent Breast(i.e.,Polands syndrome)12.3%Other5.4%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 63 COSMETIC PROCEDURES BY LOCATIONAN OFFICE FACILITYA HOSPITALA FREE-STANDING SURGICENTEROTHERWorldwide Totals31.4F.9 .4%1.4%Argentina35.6).45.0%0.0ngladesh11.2.7%5.6%2.5lgium44.4C.0.6%0.0%Brazil20.1v.0%3.8%0.0%Colombia29.4(.29.3%3.2%France37.3C.9.4%5.4%Germany41.7 .31.8%6.2%Greece67.0).9%3.1%0.0%India18.5.3.5%4.8%Iran12.6H.09.4%0.0%Italy37.91.20.7%0.3%Malaysia25.6h.5%5.9%0.0%Mexico31.45.13.6%0.0%Peru34.0.7B.4%8.9%Romania47.3E.0%7.7%0.0%South Africa23.8a.3.0%0.0%Spain33.6T.6.9%0.0%Syria36.8.8%2.4%0.0%Thailand39.8T.7%5.6%0.0%Turkiye28.4f.2%5.4%0.0%UK5.4.2%9.4%0.0%US27.8$.5G.7%0.0%Venezuela42.1.4G.5%0.0%COSMETIC PROCEDURES BY LOCATIONINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 64 MEDICAL TOURISMMEDIANAVERAGEWORLDWIDE10.0.4%Argentina10.0.8ngladesh0.0%1.3lgium5.0.6%Brazil6.0.2%Colombia30.05.9%France5.0%8.3%Germany5.0.0%Greece5.0%6.0%India9.0.2%Iran5.0.7%Italy5.0%8.0%Malaysia5.0.6%Mexico20.05.1%Peru10.0.9%Romania10.0.3%South Africa5.0%8.7%Spain10.0.9%Syria20.0%.6%Thailand15.0%.4%Turkiye15.00.7%UK2.5%6.6%US10.0.1%Venezuela5.0%8.2%MEDICAL TOURISMPERCENTAGE OF PATIENTS ATTENDING FROM OTHER COUNTRIESBrazilUSParaguayIndiaUKUSFranceNetherlandsUKArgentinaUSFranceUSVenezuelaEcuadorBelgiumUKGermanyNetherlandsSwitzerlandUSGermanyUKItalyUSUKBangladeshIraqAfghanistanTurkiyeGermanyFranceSwitzerlandSingaporeIndonesiaChinaUSCanadaSpainUSChileBrazilHungaryGermanyItalyZimbabweUKUSFranceUKGermanyLebanonIraqJordanChinaMalaysiaJapanGermanyRussiaUKUnited Arab EmiratesIrelandNigeriaCanadaUKBrazilSpainUSPanamaMOST FREQUENTLY-CITED COUNTRIES OF FOREIGN PATIENTSTOP 3123RESIDENT&ADDITIONAL STATISTICSINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 66 RESIDENT STATISTICSRESIDENT STATISTICSWORLDWIDEARGENTINABANGLADESHBELGIUMBRAZILCOLOMBIAFRANCEGERMANYGREECEINDIAITALYDO YOU HAVE ADDITIONAL SURGEONS OR RESIDENTS IN YOUR PRACTICE?Yes40.6.0g.4e.4.0#.3.5B.4U.6.6P.0%No59.4.02.64.6.0v.7.5W.6D.4Y.4P.0%IF YES,PLEASE PROVIDE COUNTS(AVERAGES):Surgeons Male 1.7 1.7 1.4 2.1 1.4 1.4 1.4 1.5 1.2 1.2 1.7 Surgeons Female 1.2 1.3 0.8 0.9 1.8 3.4 0.8 1.1 0.5 0.8 1.3 Surgeons Total 2.9 3.0 2.2 3.0 3.2 4.8 2.2 2.6 1.7 2.0 3.0 Residents Male 2.2 3.3 2.1 0.9 2.5 2.1 1.6 0.6 0.6 1.9 2.6 Residents Female 1.9 2.2 1.9 1.5 1.6 1.9 0.9 0.4 0.5 1.3 2.3 Residents Total 4.1 5.5 4.0 2.4 4.1 4.0 2.5 1.0 1.1 3.2 4.9 ARE THE RESIDENTS IN YOUR PRACTICE PART OF A TRAINING PROGRAM TO BECOME A PLASTIC SURGEON?Yes64.2s.3g.9.2u.00.0P.0S.88.5S.8D.4%No35.8&.72.1.8%.0%0.0P.0F.2a.5F.2U.6%IS THERE A REQUIREMENT FOR YOUR RESIDENTS TO COMPLETE A LOGBOOK OF PROCEDURES AS PART OF THEIR TRAINING?Yes64.8s.3W.7.7b.5.3.7r.7%.0S.8F.7%No35.2&.7B.3.37.5.7.3.3u.0F.2S.3%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 67 RESIDENT STATISTICSRESIDENT STATISTICSMALAYSIAMEXICOPERUROMANIASPAINSYRIATHAILANDUKVENEZUELADO YOU HAVE ADDITIONAL SURGEONS OR RESIDENTS IN YOUR PRACTICE?Yes53.6A.3G.1P.0$.42.50.6%.0q.4%No46.4X.7R.9P.0u.6g.5i.4u.0(.6%IF YES,PLEASE PROVIDE COUNTS(AVERAGES):Surgeons Male 1.4 1.3 2.4 2.1 1.8 2.6 2.9 3.8 0.8 Surgeons Female 1.0 0.5 0.8 3.4 0.4 0.6 0.7 1.2 0.7 Surgeons Total 2.4 1.8 3.2 5.5 2.2 3.2 3.6 5.0 1.5 Residents Male 1.8 3.8 1.4 1.6 0.8 8.6 2.7 1.1 1.8 Residents Female 2.5 1.8 0.0 0.7 0.5 8.0 3.1 0.6 1.9 Residents Total 4.3 5.6 1.4 2.3 1.3 16.6 5.8 1.7 3.7 ARE THE RESIDENTS IN YOUR PRACTICE PART OF A TRAINING PROGRAM TO BECOME A PLASTIC SURGEON?Yes33.3.6q.4W.1P.0.7.0P.0w.8%No66.7.4(.6B.9P.0%8.3 .0P.0.2%IS THERE A REQUIREMENT FOR YOUR RESIDENTS TO COMPLETE A LOGBOOK OF PROCEDURES AS PART OF THEIR TRAINING?Yes84.6u.0B.9f.7P.0.3p.0q.4f.7%No15.4%.0W.13.3P.0.70.0(.63.3%INTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 68 ADDITIONAL STATISTICSWHICH OF THE FOLLOWING,IF ANY,OCCURRED AT YOUR PRACTICE BECAUSE OF COVID-19?WORLDWIDEARGENTINABANGLADESHBELGIUMBRAZILCOLOMBIAFRANCEGERMANYGREECEINDIAIRAN ITALYHOW MANY YEARS HAVE YOU BEEN IN PRACTICE?Median19237162023221022151521Average19219162021221321171423WHAT IS YOUR GENDER?Male80.0.0.0a.5.0.1u.9.9u.0.20.0u.6male20.0.0 .08.5.0.9$.1%9.1%.0.8%0.0$.4%ARE YOU CURRENTLY A MEMBER OF ISAPS?Yes71.5.01.1s.1.0g.7c.8.9x.6u.0.3g.5%No28.5%4.0h.9&.9.02.36.2%6.1!.4%.0%3.72.5%PERCENTAGE OF PHYSICIANS PERFORMING THE FOLLOWING PROCEDURES IN 2023:Bichectomy41.55.0.8%.0G.1.04.6).0%8.71.8R.4).4%Brachioplasty69.2V.58.7s.9.4.6v.4w.4.0T.2.0h.4%Mommy Makeover63.63.3D.1x.3.2u.9T.9v.7.0u.0.0b.9%Sex Reassignment Surgery12.7%9.5(.1 .0%.0.5.6.2%4.82.0%5.6.2%Non-Surgical Vaginal Rejuvenation15.8%9.5.1%5.0&.7%.0.0%3.7.0.7.1.8DITIONAL STATISTICSINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 69 ADDITIONAL STATISTICSWHICH OF THE FOLLOWING,IF ANY,OCCURRED AT YOUR PRACTICE BECAUSE OF COVID-19?MALAYSIAMEXICOPERUROMANIASOUTH AFRICASPAINSYRIATHAILANDTURKIYEUKUSVENEZUELAHOW MANY YEARS HAVE YOU BEEN IN PRACTICE?Median102225232025111615152224Average112126202124121816162226WHAT IS YOUR GENDER?Male67.9.1.1x.6y.2s.30.0s.7.9x.1.3x.6male32.1.9%5.9!.4 .8&.7%0.0&.3.1!.9.7!.4%ARE YOU CURRENTLY A MEMBER OF ISAPS?Yes64.3t.7v.50.0u.0F.7.3V.8.3u.0.6.9%No35.7%.3#.5%0.0%.0S.3.7C.2%9.7%.0.4%7.1%PERCENTAGE OF PHYSICIANS PERFORMING THE FOLLOWING PROCEDURES IN 2023:Bichectomy18.2.1v.53.3.8R.3 .6.6t.2.2(.8E.4%Brachioplasty55.6.3u.0X.3.9h.9y.5F.9X.6q.4q.1P.0%Mommy Makeover52.2.1V.2q.4e.0p.4S.8C.8v.7p.0w.9.8%Sex Reassignment Surgery0.0%4.2%0.0%0.0%5.6.2%8.6%.0%8.0%4.2%8.4%0.0%Non-Surgical Vaginal Rejuvenation13.6.7%.03.3.5%9.1F.0%3.1%8.3%4.2.96.4DITIONAL STATISTICSINTERNATIONAL SURVEY2023Please credit the International Society of Aesthetic Plastic Surgery when citing statistical data.Contact ISAPS: 44 20 7038 7812|mediaisaps.org|www.isaps.org 70 THANK YOU TO OUR GLOBAL ALLIANCE PARTNERS AND NATIONAL SECRETARIESWe want to thank the Global Alliance Partners and National Secretaries of the countries below for their support in acquiring sufficient responses from their countries to be included in the final report.ARGENTINASociedad Argentina de Ciruga Plstica,Esttica y Reparadora(SACPER)BANGLADESHBangladesh Society of Aesthetic Plastic Surgeons(BSAPS)BELGIUMRoyal Belgian Society for Plastic Surgery(RBSPS)BRAZILSociedade Brasileira de Cirurgia Plstica(SBCP)COLOMBIASociedad Colombiana de Ciruga Plstica,Esttica y Reconstructiva(SCCP)FRANCESocit Franaise des Chirurgiens Esthtiques Plasticiens(SOFCEP)GERMANYDeutsche Gesellschaft der Plastischen,Rekonstruktiven und Aesthetischen Chirurgie,e.V.(DGPRC)Vereinigung der Deutschen Aesthetisch Plastischen Chirurgen(VDPC)GREECEHellenic Society of Plastic,Reconstructive and Aesthetic Surgery(HESPRAS)INDIAIndian Association of Aesthetic Plastic Surgeons(IAAPS)IRANIranian Society of Plastic and Aesthetic Surgeons(ISPAS)ITALYAssociazione Italiana di Chirurgia Plastica Estetica(AICPE)Societ Italiana die Chirurgia Plastica Ricostruttiva-rigenerativa ed Estetica(SICPRE)MALAYSIAMalaysian Association of Plastic,Aesthetic and Craniomaxillofacial Surgeons(MAPACS)MEXICOAsociacin Mexicana de Ciruga Plstica Esttica y Reconstructiva(AMCPER)PERUSociedad Peruana de Ciruga Plstica(SPCP)ROMANIARomanian Aesthetic Surgery Society(SRCE)SOUTH AFRICAAssociation of Plastic,Reconstructive and Aesthetic Surgeons of Southern Africa(APRASSA)SPAINAsociacin Espaola de Ciruga Esttica Plstica(AECEP)Sociedad Espaola de Ciruga Plstica Reparadora y Esttica(SECPRE)SYRIATHAILANDSociety of Aesthetic Plastic Surgeons of Thailand(ThSAPS)TURKIYETurkish Society of Aesthetic Plastic Surgery(TSAPS)UKBritish Association of Aesthetic Plastic Surgeons(BAAPS)UKAAPS-CAPSCOUSThe Aesthetic Society(American Society for Aesthetic Plastic Surgery,Inc.)VENEZUELASociedad Venezolana de Ciruga Plstica,Reconstructiva,Esttica y Maxilofacial(SVCPREM)ISAPS BOARD OF DIRECTORSdesign by www.bb- photo credits by ISAPS EXECUTIVE OFFICE19 Mantua RoadMount Royal,NJ 08061United StatesPhone: 44 20 7038 7812Email:ISAPSisaps.org Website:www.isaps.orgMARKETING OFFICEboeld communicationReitmorstrae 25,80538 Munich,GermanyEmail:marketingisaps.orgWebsite:www.bb-GLOBAL SURVEY EDITORGianluca CAMPIGLIO,MD,PhD ItalyFOR PRESS INQUIRIES,PLEASE CONTACT:mediaisaps.orgPRESIDENT Lina TRIANA,MD ColombiaPRESIDENT-ELECT Arturo RAMREZ-MONTAANA,MD MexicoSECRETARY Paraskevas KONTOES,MD,PhD GreeceTREASURER Kai SCHLAUDRAFF,MD,FEBOPRAS SwitzerlandPAST PRESIDENT Nazim CERKES,MD,PhD TurkiyeMEMBERSHIP CHAIR Andre CERVANTES,MD BrazilMEMBER-AT-LARGE Fabian CORTIAS,MD ArgentinaMEMBER-AT-LARGE Montserrat FONTBONA,MD ChileMEMBER-AT-LARGE Tim PAPADOPOULOS,MD AustraliaMEMBER-AT-LARGE Ivar VAN HEIJNINGEN,MD BelgiumNATIONAL SECRETARIES CHAIR Bertha TORRES GOMEZ,MD MexicoEDUCATION COUNCIL CHAIR Ozan SOZER,MD United StatesTRUSTEEÐICS COMMITTEE CHAIR Kai KAYE,MD,PhD SpainPARLIAMENTARIAN Sanguan KUNAPORN,MD ThailandEDUCATION COUNCIL VICE-CHAIR Francisco BRAVO,MD SpainEXECUTIVE DIRECTOR Sarah JOHNSON UKINTERNATIONAL SURVEY2023
2024-09-11
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www.efpia.euThe Pharmaceutical Industry in FiguresKey Data 2024EFPIA Key Data|20242Thanks to advances in science and technology,the research-based pharmaceutical industry is entering an exciting new era in medicines development.Research methods are evolving and we have many promising prospects on the horizon,with ground-breaking cell and gene therapies being increasingly available*.The innovative pharmaceutical industry is driven by,and drives,medical progress.It aims to turn fundamental research into innovative treatments that are widely available and accessible to patients.Already,the industry has contributed to significant improvements in patient well-being.Todays European citizens can expect to live up to 30 years longer than they did a century ago.Some major steps in biopharmaceutical research,complemented by many smaller steps,have allowed for reductions in mortality,for instance from HIV/AIDS-related causes and several cancers.High blood pressure and cardiovascular diseases can be controlled with antihypertensive and cholesterol-lowering medicines;knee or hip replacements prevent patients from immobility;and some cancers can be controlled or even cured with the help of new targeted treatments.European citizens can expect not only to live longer,but to live better quality lives.Yet major hurdles remain,including Alzheimers,Multiple Sclerosis,many cancers,and rare diseases.THE PHARMACEUTICAL INDUSTRY:A KEY ASSET TO SCIENTIFIC AND MEDICAL PROGRESSSource:HIV/AIDS surveillance in Europe 2023(2022 data),WHO European Region&European Centre for Disease Prevention and Control(ECDC),28 November 2023*https:/www.efpia.eu/media/676661/iqvia_efpia-pipeline-review_final-report_public-final.pdfTOTAL NUMBER OF DEATHS AMONG AIDS CASES IN EUROPE(TOTAL EU/EEA)050010001500200025002022201320142015201620172018201920202021213776778312781382149815221667166418983INDUSTRY(EFPIA total)2000 2010202020222023Production127,504199,730290,309363,300390,000(e)Exports(1)(2)90,935276,357509,828683,375680,000(e)Imports68,841204,824347,124475,277480,000(e)Trade balance22,09471,533162,704208,098200,000(e)R&D expenditure17,84927,92039,44247,01050,000(e)Employment(units)556,506699,059846,282894,406900,000(e)R&D employment(units)88,397116,253121,717 123,465130,000(e)Total pharmaceutical market value at ex-factory prices89,449 153,685236,401269,965290,000(e)Payment for pharmaceuticals by statutory health insurance systems(ambulatory care only)76,909129,464145,262163,813175,000(e)THE PHARMACEUTICAL INDUSTRY:A KEY ASSET TO THE EUROPEAN ECONOMYAs well as driving medical progress by researching,developing and bringing new medicines that improve health and quality of life for patients around the world,the research-based pharmaceutical industry is a key asset of the European economy.It is one of Europes top performing high-technology sectors.Values in million unless otherwise stated(1)Data relate to EU-27,Norway,Switzerland and United Kingdom since 2005(EU-15 before 2005);Croatia and Serbia included since 2010;Turkey included since 2011;Russia included since 2013 (2)Data relating to total exports and total imports include EU-27 intra-trade(double counting in some cases)Source:EFPIA member associations(official figures)-(e):EFPIA estimate;Eurostat(EU-27 trade data 2000-2023)EFPIA Key Data|2024467.1%9.4%PharmergingRest ofthe WorldUSA3.8%Japan3.9.8%Europe(Top 5)MAIN TRENDSThe research-based pharmaceutical industry can play a critical role in restoring Europe to growth and ensuring future competitiveness in an advancing global economy.In 2023 it invested an estimated 50,000 million in R&D in Europe.It directly employs some 900,000 people and generates about three times more employment indirectly upstream and downstream than it does directly(PwC,Economic and societal footprint of the pharmaceutical industry in Europe,June 2019).However,the sector faces real challenges.Besides the additional regulatory hurdles and escalating R&D costs,the sector has been severely hit by the impact of fiscal austerity measures introduced by governments across much of Europe since 2010.There is rapid growth in the market and research environment in emerging economies such as Brazil,China and India,leading to a gradual migration of economic and research activities from Europe to these fast-growing markets.During the period 2018-2023 the Brazilian,Chinese and Indian markets grew by 12.3%,5.4%and 9.9%respectively compared to an average market growth of 7.4%for the top 5 European Union markets and 8.4%for the US market(source:IQVIA MIDAS,May 2024).In 2023 North America accounted for 53.3%of world pharmaceutical sales compared with 22.7%for Europe.According to IQVIA(MIDAS May 2024),67.1%of sales of new medicines launched during the period 2018-2023 were on the US market,compared with 15.8%on the European market(top 5 markets).The fragmentation of the EU pharmaceutical market has resulted in a lucrative parallel trade.This benefits neither social security nor patients and deprives the industry of additional resources to fund R&D.Parallel trade was estimated to amount to 6,366 million(value at ex-factory prices)in 2022.GEOGRAPHICAL BREAKDOWN(BY MAIN MARKETS)OF SALES OF NEW MEDICINES LAUNCHED DURING THE PERIOD 2018-2023Note:New medicines cover all new active ingredients marketed for the first time on the world market during the period 2018-2023Europe(Top 5)comprises France,Germany,Italy,Spain and United KingdomPharmerging comprises 21 countries ranked by IQVIA as high-growth pharmaceutical markets(Algeria,Argentina,Bangladesh,Brazil,Colombia,Chile,China,Egypt,India,Indonesia,Kazakhstan,Mexico,Nigeria,Pakistan,Philippines,Poland,Russia,Saudi Arabia,South Africa,Turkey and Vietnam)Source:IQVIA(MIDAS May 2024)5PHARMACEUTICAL R&D EXPENDITURE IN EUROPE,USA,JAPAN AND CHINA(MILLION,2022 CONSTANT EXCHANGE RATE*),1990-2022*Note:USA:1=1,0530$;Japan:1=138,03;China:1=7,0788 Yuan(*2001 year)Source:EFPIA member associations,PhRMA,JPMA,China Statistical YearbookSHARE OF PARALLEL IMPORTS IN PHARMACY MARKET SALES(%)2022Note:U.K.:in%of pharmacy market sales at reimbursement pricesSource:EFPIA member associations(estimate)0,00010,00020,00030,00040,00050,00060,00070,00080,00090,000JapanUSAChinaEurope20102000199017,84927,92038,640 9,24420,2882020202210,36347,01071,459 14,8179,575 39,44268,76711,084 1,732272*7,7666,4603,7395,406EuropeUSAJapanChina051015202530U.K.SwedenPolandNetherlands NorwayIrelandDenmarkBelgiumAustriaGermanyFinland4.33.729.42.57.05.45.42.61.711.29.9EFPIA Key Data|20246PHARMACEUTICAL INDUSTRY RESEARCH AND DEVELOPMENT IN EUROPEAll new medicines introduced into the market are the result of lengthy,costly and risky research and development(R&D)conducted by pharmaceutical companies:By the time a medicinal product reaches the market,an average of 12-13 years will have elapsed since the first synthesis of the new active substance;The cost of researching and developing a new chemical or biological entity is estimated at 3,130 million($3,296 million in year 2022 dollars)in 2022 applying the methodology used by Joseph A.DiMasi in its 1991,2003 and 2016 Tuft Center for the Study of Drug Development studies(Wild,C.and Fabian,D.(2024),AIHTA,The Role of Public Contributions to the Development of Health Innovations,HTA-Projektbericht 158);On average,only one to two of every 10,000 substances synthesised in laboratories will successfully pass all stages of development required to become a marketable medicine.PHASES OF THE RESEARCH AND DEVELOPMENT PROCESSScreening(10,000 molecules)05 yearsPatent applicationPreclinical developmentClinical trialsAcute toxicityPharmacologyChronic toxicityPhase IPhase IIPhase IIIPriceReimbursementPharmacovigilanceRegistration/Marketing authorisation10 years10 years of R&D2 to 3 years of administrative procedures15 years20 years patent expiry25 years SPC(supplementary protection certificate)max. 5 years1 medicinal product7PHARMACEUTICAL INDUSTRY RESEARCH AND DEVELOPMENT IN EUROPEEFPIA 2022 million millionAustria 304Belgium 5,692Bulgaria 98Croatia 40Cyprus 85Czech Rep.106Denmark 1,495Estonia n.aFinland 263France 4,451Germany 9,372Greece 92Hungary 298Iceland n.aIreland 305Italy 1,865Latvia n.aLithuania n.aMalta n.aNetherlands 900Norway 126Poland 1,328Portugal 99Romania 110Russia 706Slovakia 35Slovenia 257Spain 1,395Sweden 1,104Switzerland 9,556Turkey 71U.K.6,857 TOTAL 47,010 Note:The figures relate to the R&D carried out in each country.Netherlands,Poland,Slovenia,U.K.:2021 data;Hungary,Russia,Slovakia,Turkey:2020 data;France:2017 data;Norway,Sweden:2015 data;Cyprus,Ireland:2013 data;Croatia:2011 dataBelgium,Croatia,Denmark,France,Greece,Ireland,Italy,Netherlands,Norway(LMI members),Poland,Romania,Slovenia,Sweden(LIF members),Switzerland(Interpharma members),Turkey:estimateSource:EFPIA member associations(official figures)EFPIA Key Data|20248Allocation of R&D investments by function(%)15.948.420.04.311.5Pre-human/Pre-clinicalApprovalPharmacovigilance(Phase IV)Uncategorized 8.511.128.8Phase IPhase IIPhase IIIClinical TrialsClinical TrialsEuropeUSAJapanOthersChina0204060801001201401602019-20232014-20182009-20132004-20084764437167148161423266681431256737434Source:PhRMA,Annual Membership Survey 2023(percentages calculated from 2022 data;total values may be affected by rounding)Source:CITELINE April 2024&SCRIP EFPIA calculations(according to nationality of mother company)Note:Up to 2017 China is included under Others ALLOCATION OF R&D INVESTMENTS BY FUNCTION(%)NUMBER OF NEW CHEMICAL AND BIOLOGICAL ENTITIES(2004-2023)9EuropeUSA0102030402019-20232014-20182009-2013China3.035.63.79.210.86.75.116.32.9PHARMACEUTICAL R&D EXPENDITURE ANNUAL GROWTH RATE(%)IMPORTANCE OF PHARMACEUTICAL R&D In 2022 the pharmaceutical industry invested more than 47,000 million in R&D in Europe.A decade of strong US market dominance led to a significant shift of economic and research activity towards the US during the period 1995-2005,a trend that has been exacerbating since 2015.Additionally,Europe is now facing increasing competition from emerging economies:rapid growth in the market and research environments in countries such as China and Korea are contributing to the move of economic and research activities to non-European markets.In 2023 China outpaced Europe as originator of new active substances launched for the first time on the world market,with respectively 25 and 17 new substances,the US still leading with 28 on a total of 90.After having lost its crown as the top innovation region in the world in 2000,Europe has now moved to the third place on the podium as originator of new molecules.The geographical balance of the pharmaceutical market and ultimately the R&D base is likely to shift gradually towards those fast-growing emerging economies.ESTIMATED FULL COST OF BRINGING A NEW CHEMICAL OR BIOLOGICAL ENTITY TO MARKET($MILLION-YEAR 2022$)Source:Wild,C.and Fabian,D.(2024),AIHTA,The Role of Public Contributions to the Development of Health Innovations,HTA-Projektbericht 158Note:USA,China:data relating to period 2019-2022Source:EFPIA,PhRMA,China Statistical Yearbook 2002-202302004006008001000120014001600200022002400260028003000320034001991594.120031368.020163295.9EFPIA Key Data|202410RANKING OF INDUSTRIAL SECTORS BY OVERALL SECTOR R&D INTENSITY(R&D AS PERCENTAGE OF NET SALES 2022)According to EUROSTAT data,the pharmaceutical industry is the high technology sector with the highest added value per person employed,significantly higher than the average value for high-tech and manufacturing industries.The pharmaceutical industry is also the sector with the highest ratio of R&D investment to net sales.According to the 2023 EU Industrial R&D Investment Scoreboard,health industries invested about 261.4 billion in R&D in 2022,accounting for 20.9%of total business R&D expenditure worldwide.Construction2.3%HealthIndustriesICT ServicesICT productsAutomobiles/transportsTotalAerospace&DefenceFinancialOthersIndustrialsEnergy0.4.9.9%7.4%4.8%4.7%4.5%3.5%2.7%2.3%Chemicals2.2%Note:Data relate to the top 2,500 companies with registered offices in the EU-27(367),Japan(229),the US(827),China(679)and the Rest of the World(398),ranked by total worldwide R&D investment(with investment in R&D above 53 million).Companies are distributed by main sector according to the International Classification Benchmark(ICB);health industries include pharmaceuticals,biotechnology,medical equipment,healthcare equipment&services,healthcare providers and medical supplies.Source:The 2023 EU Industrial R&D Investment Scoreboard,European Commission,JRC/DG R&I11PHARMACEUTICAL PRODUCTIONEFPIA 2022 million millionAustria 1,453Belgium 40,959Bulgaria 322Croatia 553Cyprus 253Czech Rep.800Denmark 21,501Estonia n.aFinland 1,964France 32,773Germany 37,405Greece 1,876Hungary 3,136Iceland 40Ireland 19,305Italy 49,000Latvia 330Lithuania n.aMalta 307Netherlands 6,180Norway 1,432Poland 2,903Portugal 2,334Romania 655Russia 6,459Slovakia 356Slovenia 6,955Spain 22,957Sweden 11,910Switzerland 56,641Turkey 3,497U.K.29,044 TOTAL 363,300 Note:All data based on SITC 54Malta:2021 data;Norway,Russia,Turkey:2020 data;Cyprus:2018 data;Slovakia:2017 data;Ireland:2014 data;Romania:2013 data;Netherlands:2010 dataCroatia,Denmark,France,Ireland,Italy,Netherlands,Norway,Portugal,Slovakia,Slovenia,Spain,Sweden,Switzerland:estimateBulgaria,Croatia,Cyprus,France,Hungary,Ireland,Latvia,Norway,Poland,Portugal,Romania,Slovenia:veterinary products excludedSource:EFPIA member associations(official figures)EFPIA Key Data|202412EMPLOYMENT IN THE PHARMACEUTICAL INDUSTRYThe research-based pharmaceutical industry is one of Europes major high-technology industrial employers.Recent studies in some countries showed that the research-based pharmaceutical industry generates about three times more employment indirectly upstream and downstream than it does directly(PwC,Economic and societal footprint of the pharmaceutical industry in Europe,June 2019).Furthermore,a significant proportion of these are valuable skilled jobs,for instance in the fields of academia or clinical science,which can help maintain a high-level knowledge base and prevent a European“brain drain”.EFPIA 2022 Units UnitsAustria 17,915Belgium 43,501Bulgaria 15,750Croatia 6,318Cyprus 2,220Czech Rep.18,000Denmark 39,815Estonia 380Finland 6,118France 95,867Germany 123,475Greece 32,637Hungary 34,800Iceland 900Ireland 45,000Italy 68,600Latvia 2,681Lithuania 1,220Malta 1,370Netherlands 20,000Norway 4,500Poland 30,021Portugal 8,900Romania 33,550Russia n.aSlovakia 2,287Slovenia 13,090Spain 50,600Sweden 15,000Switzerland 47,600Turkey 42,291U.K.70,000 TOTAL 894,406 Note:Hungary,U.K.:2021 data;Netherlands,Turkey:2020 data;Slovakia:2017 data;Estonia:2016 data;Lithuania:2013 dataBelgium,Bulgaria,Croatia,Estonia,France,Ireland,Italy,Netherlands,Norway,Poland,Portugal,Romania,Slovenia,Sweden,Switzerland,Turkey,United Kingdom:estimateSource:EFPIA member associations(official figures)13Note:Data includes Iceland(since 2017),Croatia,Lithuania and Turkey(since 2010),Bulgaria,Estonia and Hungary(since 2009),Czech Republic(since 2008),Cyprus(since 2007),Latvia,Romania&Slovakia(since 2005),Malta,Poland and Slovenia(since 2004)Source:EFPIA member associations(official figures)-(e):EFPIA estimateNote:Data includes Iceland(since 2017),Greece&Lithuania(since 2013),Bulgaria and Turkey(since 2012),Poland(since 2010),Czech Republic,Estonia and Hungary(since 2009),Romania(since 2005)and Slovenia(since 2004)Croatia,Cyprus,Latvia,Malta,Russia,Serbia,Slovakia:data not availableSource:EFPIA member associations-(e):EFPIA estimateEMPLOYMENT IN THE PHARMACEUTICAL INDUSTRY(1990-2023)EMPLOYMENT IN PHARMACEUTICAL R&D(1990-2023)1990500,8792000556,5062010699,0592020846,2822022894,4062023900,000(e)199076,126200088,3972010116,2532020121,7172022123,4652023130,000(e)EFPIA Key Data|202414PHARMACEUTICAL SALESPRICE STRUCTUREThe world pharmaceutical(prescription)market was worth an estimated 1,288,299 million($1,393,038 million)at ex-factory prices in 2023.The North American market(USA&Canada)remained the worlds largest market with a 53.3%share,well ahead of Europe,China and Japan.Distribution margins,which are generally fixed by governments,and VAT rates differ significantly from country to country in Europe.On average,approximately one third of the retail price of a medicine reverts to distributors(pharmacists and wholesalers)and the State.Note:Europe includes Belarus,Turkey,Russia and Ukraine;percentages might not add up due to roundingSource:IQVIA MIDAS(audited sales)Q4 2023 MAT,May 2024;data relate to the 2023 global retail and hospital pharmaceutical market(prescription only)at ex-factory prices.Note:Non-weighted average for Europe(average estimate for 26 countries)Source:EFPIA member associationsBREAKDOWN OF THE WORLD PHARMACEUTICAL MARKET 2023 SALESBREAKDOWN OF THE RETAIL PRICE OF A MEDICINE,2022(%)67.3%Manufacturer17.0%Pharmacist5.0%Wholesaler10.7%State(VAT and other taxes)North America(USA,Canada)Europe53.3.7%Japan4.3%China7.5rica,Asia*&Australia*Excluding China&Japan8.0%4.2%AmericaLatin 15PHARMACEUTICAL MARKET VALUE(at exfactory prices)Graph 17Graph 18Breakdown of the world pharmaceutical market 2014 salesBreakdown of the retail price of a medicine,2013(%)Latin America4.7f.1%Manufacturer19.2%Pharmacist4.9%Wholesaler9.8%State(VAT and other taxes)Africa,Asia&Australia*Excluding Japan16.6PIA 2022 million millionAustria 5,719Belgium 7,064Bulgaria 1,724Croatia 1,253Cyprus 437Czech Rep.3,191Denmark 3,561Estonia 432Finland 2,991France 35,328Germany 50,609Greece 4,965Hungary 2,666Iceland 231Ireland 2,741Italy 25,808Latvia 452Lithuania 752Luxembourg 322Malta 196Netherlands 7,675Norway 3,424Poland 8,911Portugal 4,194Romania 5,749Russia 18,398Serbia 1,118Slovakia 1,739Slovenia 861Spain 19,572Sweden 5,017Switzerland 7,027Turkey 6,985U.K.28,853 TOTAL 269,965 Note:Medicinal products as defined by Directive 2001/83/ECCyprus,Denmark,Finland,Iceland,Latvia,Lithuania,Netherlands,Norway,Russia,Slovenia,Sweden:pharmaceutical market value at pharmacy purchasing prices Belgium,France,Germany,Greece,Ireland,Italy,Norway,Spain,U.K.:estimateSource:EFPIA member associations(official figures);Lithuania,Serbia:IQVIA;Russia:2020 data;Malta:2019 data The figures above are for pharmaceutical sales,at ex-factory prices,through all distribution channels(pharmacies,hospitals,dispensing doctors,supermarkets,etc.),whether dispensed on prescription or at the patients request.Sales of veterinary medicines are excluded.EFPIA Key Data|202416VAT RATES APPLICABLE TO MEDICINESThe table below shows the VAT rates applied to medicines in European countries as of 1 January 2024.Country Standard VAT rate(%)VAT rates applied to medicines Prescription(%)OTC(%)Austria 20,0 10,0 10,0 Belgium 21,0 6,0 6,0 Bulgaria 20,0 20,0 20,0 Croatia 25,0 5,0 5,0 Cyprus 19,0 5,0 5,0 Czech Rep.21,0 10,0 10,0 Denmark 25,0 25,0 25,0 Estonia 20,0 9,0 9,0 Finland 24,0 10,0 10,0 France(1)20,0 2,1 10,0 Germany 19,0 19,0 19,0 Greece 24,0 6,0 6,0-13,0 Hungary 27,0 5,0 5,0 Iceland 24,0 24,0 24,0 Ireland(2)23,0 0-23,0 0-23,0Italy 22,0 10,0 10,0 Latvia 21,0 12,0 12,0 Lithuania(3)21,0 5,0 21,0 Luxembourg 17,0 3,0 3,0 Malta 18,0 0,0 0,0 Netherlands 21,0 9,0 9,0 Norway 25,0 25,0 25,0 Poland 23,0 8,0 8,0 Portugal 23,0 6,0 6,0 Romania 19,0 9,0 19,0 Russia 20,0 10,0 10,0 Serbia 20,0 10,0 10,0 Slovakia 20,0 10,0 20,0 Slovenia 22,0 9,5 9,5 Spain 21,0 4,0 4,0 Sweden 25,0 0,0 25,0 Switzerland 8,1 2,6 2,6 Turkey 20,0 10,0 10,0 U.K.(4)20,0 0-20,0 20,0(1)France:reimbursable medicines 2.1%;non-reimbursable medicines 10.0%(2)Ireland:oral medication 0%;other medication 23%(3)Lithuania:reimbursable medicines 5.0%;non-reimbursable medicines 21.0%(4)U.K.:0%for prescription medicines dispensed in the Community;20%for prescription medicines consumed in the hospital setting17GENERICS AND BIOSIMILARSGenerics and biosimilars are usually produced by a manufacturer who is not the inventor of the original chemical or biological substance.They can be marketed after expiry of the intellectual property protection rights of the innovative product.Data might not be strictly comparable across countries due to differences in procurement and reimbursement practices.Note:Bulgaria,Croatia,Czech Republic,Denmark,Estonia,Finland,Hungary,Luxembourg,Slovenia,U.K.:share of generics in pharmacy market salesAustria,Belgium,France,Germany,Greece,Italy,Netherlands,Portugal,Spain:share of generics in reimbursable pharmacy market salesIreland,Latvia,Lithuania,Norway,Poland,Romania,Russia,Serbia,Slovakia,Sweden,Switzerland,Turkey:share of generics in total market salesLithuania,Russia:2020 data;Cyprus,Iceland,Malta:data not available France:data relate only to those active substances listed on the official list of medicinesSource:EFPIA member associationsSHARE(ESTIMATE-IN%)ACCOUNTED FOR BY GENERICS AND BIOSIMILARS IN PHARMACEUTICAL MARKET SALES VALUE(AT EX-FACTORY PRICES),20220 0PX.0Austria17.1Belgium29.6Bulgaria40.0Croatia26.7Czech Republic33.0Denmark19.5Estonia23.0Finland17.7France18.0Germany28.7Greece36.8Hungary16.0Ireland21.9Italy47.0Latvia24.0Lithuania29.030.2Norway5.1Luxembourg54.0Poland22.4Portugal25.5Romania31.6 Russia21.8Slovenia27.8Serbia20.9Slovakia22.6Sweden23.2Spain14.6Switzerland26.2U.K.31.6Turkey70%NetherlandsEFPIA Key Data|202418PHARMACEUTICAL EXPORTSEFPIA 2022 million millionAustria 13,735Belgium 98,946Bulgaria 1,152Croatia 1,039Cyprus 383Czech Republic 3,724Denmark 21,219Estonia 126Finland 1,203France 36,734Germany 119,965Greece 2,568Hungary 7,434Iceland 40Ireland 79,133Italy 46,726Latvia 688Lithuania 1,030Luxembourg 138Malta 378Netherlands 52,957Norway 885Poland 5,314Portugal 1,955Romania 1,006Slovakia 692Slovenia 14,696Spain 27,581Sweden 13,089Switzerland 97,256Turkey 1,645United Kingdom 29,938 TOTAL 683,375 Note:All data based on SITC 54Source:Eurostat(COMEXT database May 2024)Iceland:OECD;Norway:LMI;Switzerland:Swiss Federal Customs Administration;Turkey:Turkish Statistical Institute;UK:ONS Trade in goods 19PHARMACEUTICAL IMPORTSEFPIA 2022 million millionAustria 12,599Belgium 76,690Bulgaria 1,874Croatia 1,738Cyprus 448Czech Republic 6,812Denmark 5,870Estonia 742Finland 2,479France 33,453Germany 77,826Greece 4,126Hungary 5,556Iceland 238Ireland 11,601Italy 37,283Latvia 933Lithuania 1,530Luxembourg 618Malta 363Netherlands 41,786Norway 3,050Poland 9,971Portugal 3,768Romania 4,618Slovakia 2,536Slovenia 8,603Spain 23,693Sweden 6,244Switzerland 47,612Turkey 4,628United Kingdom 35,989 TOTAL 475,277 Note:All data based on SITC 54Source:Eurostat(COMEXT database May 2024)Iceland:OECD;Norway:LMI;Switzerland:Swiss Federal Customs Administration;Turkey:Turkish Statistical Institute;UK:ONS Trade in goodsEFPIA Key Data|202420PHARMACEUTICAL TRADE BALANCEEFPIA 2022 million millionAustria 1,136Belgium 22,256Bulgaria-722Croatia-699Cyprus-65Czech Republic-3,088Denmark 15,349Estonia-616Finland-1,276France 3,281Germany 42,139Greece-1,558Hungary 1,878Iceland-198Ireland 67,532Italy 9,443Latvia-245Lithuania-500Luxembourg-480Malta 15Netherlands 11,171Norway-2,165Poland-4,657Portugal-1,813Romania-3,612Slovakia-1,844Slovenia 6,093Spain 3,888Sweden 6,845Switzerland 49,644Turkey-2,983United Kingdom-6,051 TOTAL 208,098 Note:All data based on SITC 54Source:Eurostat(COMEXT database May 2024)Iceland:OECD;Norway:LMI;Switzerland:Swiss Federal Customs Administration;Turkey:Turkish Statistical Institute;UK:ONS Trade in goods21USA33.1ExportImport010 3040403020100Others34.0Switzerland15.539.5USA13.3Others32.3Switzerland6.9U.K.4.4South Korea3.7ChinaChina7.7U.K.6.2Japan3.5SITC 54 Medicinal and pharmaceutical products SITC 71 Power generating machinery and equipment SITC 7 Offce machines and automatic data processing machinesSITC 76 Telecommunications,sound-recording and reproducing apparatus and equipmentSITC 77 Electrical machinery,apparatus and appliancesSITC 87 Professional,scientifc and controlling instruments and apparatus-100,000-80,000-60,000-40,000-20,00020,00040,00060,00080,000100,000120,000140,000160,000180,0000200,000157,57117,64821,684-42,418-64,711-63,887Source:Eurostat,COMEXT database,May 2024Source:Eurostat,COMEXT database,May 2024EU-27 TRADE BALANCE-HIGH TECHNOLOGY SECTORS(MILLION)-2023THE EUROPEAN UNIONS TOP 5 PHARMACEUTICAL TRADING PARTNERS-2023EFPIA Key Data|202422TOTAL SPENDING(PUBLIC AND PRIVATE)ON HEALTHCARE AS A PERCENTAGE OF GDP AT MARKET PRICES Country 1980 1990 2000 2010 2020 2022 Austria 7.0 7.7 9.2 10.2 11.4 11.4Belgium 6.2 7.1 8.0 10.2 11.2 10.9Czech Republic-3.7 5.7 7.6 9.2 9.1Denmark 8.4 8.0 8.1 10.6 10.6 9.5Estonia-5.2 6.6 7.6 6.9Finland 5.9 7.3 7.1 9.1 9.6 10.0France 6.8 8.0 9.6 11.2 12.1 12.1Germany 8.1 8.0 9.9 11.1 12.7 12.7Greece-6.1 7.2 9.6 9.5 8.6Hungary-6.8 7.4 7.3 6.7Iceland 5.9 7.4 8.9 8.4 9.6 8.6Ireland 7.5 5.6 5.9 10.5 7.1 6.1Italy-7.0 7.6 8.9 9.6 9.0Latvia-5.4 6.1 7.2 8.8Lithuania-6.2 6.8 7.5 7.5Luxembourg 4.8 5.3 5.9 6.7 5.7 5.5Netherlands 6.5 7.0 7.7 10.2 11.2 10.2Norway 5.4 7.1 7.7 8.9 11.2 7.9Poland-4.3 5.3 6.5 6.5 6.7Portugal 4.8 5.5 8.6 10.0 10.5 10.6Slovakia-5.3 7.7 7.1 7.8Slovenia-7.8 8.6 9.4 8.8Spain 5.0 6.1 6.8 9.1 10.7 10.4Sweden 7.7 7.2 7.3 8.3 11.3 10.7Switzerland 6.4 7.6 9.1 9.9 11.7 11.3Turkey 2.4 2.4 4.6 5.0 4.6 4.3United Kingdom 5.1 5.1 7.1 9.7 12.2 11.3Europe 6.1 6.4 7.2 8.7 9.4 9.0USA 8.2 11.2 12.5 16.2 18.8 16.6Japan 6.1 5.7 7.0 9.1 11.0 11.5Note:Europe:non-weighted average(27 countries)EFPIA calculationsSource:OECD Health Statistics 2023,May 202423PAYMENT FOR PHARMACEUTICALS BY COMPULSORY HEALTH INSURANCE SYSTEMS AND NATIONAL HEALTH SERVICES(ambulatory care only)EFPIA 2022 million millionAustria 3,598Belgium 6,069Bulgaria 523Croatia 507Cyprus 210Czech Rep.1,470Denmark 875Estonia 191Finland 1,758France 28,325Germany 51,297Greece 2,108Hungary 1,126Iceland 109Ireland 2,229Italy 7,600Latvia 192Lithuania 477Luxembourg 301Malta 123Netherlands 3,315Norway 1,215Poland 2,158Portugal 1,568Romania 1,608Russia 1,500Serbia 325Slovakia 1,381Slovenia 453Spain 12,326Sweden 2,850Switzerland 6,873Turkey 5,901U.K.13,252 TOTAL 163,813 Note:Lithuania:2021 data;Croatia,Netherlands,Russia:2020 data;Source:EFPIA member associations(official figures)EFPIA Key Data|202424MAIN CAUSES OF MORTALITY ACROSS OECD COUNTRIES,2021(OR NEAREST YEAR)1.Kjaer SK,Nygrd M,Sundstrm K,et al.Final analysis of a 14-year long-term follow-up study of the effectiveness and immunogenicity of the quadrivalent human papillomavirus vaccine in women from four Nordic countries.EClinicalMedicine 2020;23:100401.2.Fernandes A,Viveros-Carreo D,Hoegl J,et al.Human papillomavirus-independent cervical cancer.International Journal of Gynecologic Cancer 2022;32:1-7.CASESDEATHSWithout HPV VaccinationWith HPV Vaccination30,00025,00020,00015,00010,0005,000028,92512,7651,533677-27,392 cases-12,089 casesHPV VACCINES ARE AT LEAST 94.7FECTIVE IN PREVENTING HPV INFECTIONSDiseases ofthe respiratorysystem9%ExternalCauses6%Alzheimersand otherdementias6%Diabetes3cidents4%Suicide1%Diseases ofcirculatorysystem28%Strokes6%Ischaemicheartdiseases11%COPD3%Pneumonia3ncers21%Lung4%Prostate1%Colorectal2%Breast(female)1%COVID 197%ALL DEATHS12,818,369Note:Other causes of death not shown in this figure represent 21%of all deaths.Source:OECD Health Statistics 2023.THIS MEANS THAT,EVERY YEAR,OVER 27,000 CASES AND 12,000 CERVICAL CANCER-RELATED DEATHS CAN BE PREVENTED BY HPV VACCINES25THE ADDED VALUE OF MEDICINES IN HEALTHCAREMedicines constitute the smallest part of healthcare costs with,on average,17.3%of total health expenditure in Europe being spent on pharmaceuticals and other medical goods.In costly diseases such as cancer and rheumatoid arthritis,medicines account for less than 20%of the total disease costs.Medicines can also generate additional savings,for example by substantially reducing costs in other areas of healthcare,including hospital stays and long-term care costs.Source:OECD Health Statistics 2022,May 2023 EFPIA calculations(non-weighted average for 26 EU&EFTA countries)*Treatment duration,INF=interferon;Source:PhRMA,Prescription Medicines:International Costs in Context(2017)BREAKDOWN OF TOTAL HEALTH EXPENDITURE IN EUROPE 2021CHRONOLOGY OF HEPATITIS C TREATMENT(1999-2015)1Outpatient care&othersMedical goods(including pharmaceuticals)In-patient care(hospital)39.3C.4.3%Hepatitis C is the leading cause of liver transplants and the reason liver cancer is on the rise1st generation(1999-2010)Interferon and ribavarin injection48 weeks*2nd generation(2011-2013)Protease inhibitors w/IFN injection24-28 weeks*3rd generation(2013-2014)Polymerase inhibitors w/IFN injection12 weeks*4th generation(2014-2015)Oral combination therapies8-12 weeks* 133A%cure rate63-80%cure rate90%cure rate95-96%cure rateImproved tolerance and ease of treatment26EFPIA Key Data|2024EFPIA MEMBER ASSOCIATIONSASSOCIATIONS WITH LIAISON STATUSAustria Fachverband der Chemischen Industrie sterreichs(FCIO)Belgium Association Gnrale de lIndustrie du Mdicament(pharma.be)Denmark LaegemiddelindustriforeningenThe Danish Association of the Pharmaceutical Industry(Lif)Finland Lketeollisuus ryPharma Industry Finland(PIF)France Les Entreprises du Mdicament(LEEM)Germany Verband Forschender Arzneimittelhersteller(VfA)Greece Hellenic Association of Pharmaceutical Companies(SFEE)Ireland Irish Pharmaceutical Healthcare Association(IPHA)Italy Associazione delle Imprese del Farmaco(Farmindustria)Netherlands Vereniging Innovatieve Geneesmiddelen NederlandNorway LegemiddelindustriforenigenNorwegian Association of Pharmaceutical Manufacturers(LMI)Poland Employers Union of Innovative Pharmaceutical Companies(Infarma)Portugal Associao Portuguesa da Indstria Farmacutica(Apifarma)Russia Association of International Pharmaceutical Manufacturers(AIPM)Spain Asociacin Nacional Empresarial de la Industria Farmacutica(Farmaindustria)Sweden LkemedelsindustrifreningenThe Swedish Association of the Pharmaceutical Industry(LIF)Switzerland Verband der forschenden pharmazeutischen Firmen der Schweiz(Interpharma)Turkey Arastirmaci Ilac Firmalari Dernegi(AIFD)United Kingdom The Association of the British Pharmaceutical Industry(ABPI)Bosnia-Herzegovina:Association of Research-based Medicine Producers(UIPL)Bulgaria:Association of Research-based Pharmaceutical Manufacturers in Bulgaria(ARPharM)Croatia:Innovative Pharmaceutical Initiative(iF!)Cyprus:Cyprus Association of Pharmaceutical Companies(KEFEA)Czech Republic:Association of Innovative Pharmaceutical Industry(AIFP)Estonia:Association of Pharmaceutical Manufacturers in Estonia(APME)Hungary:Association of Innovative Pharmaceutical Manufacturers(AIPM)Iceland:Icelandic Association of the Pharmaceutical Industry(FRUMTK)Latvia:Association of International Research-based Pharmaceutical Manufacturers(SIFFA)Lithuania:The Innovative Pharmaceutical Industry Association(IFPA)Luxembourg:Innovative Medicines for Luxembourg(IML)Macedonia:Association of Foreign Innovative Pharmaceutical Manufacturers(HOBA)Malta:Maltese Pharmaceutical Association(PRIMA)Romania:Association of International Medicines Manufacturers(ARPIM)Serbia:Innovative Drug Manufacturers Association(INOVIA)Slovakia:Slovak Association of Innovative Pharmaceutical Industry(AIFP)Slovenia:Forum of International Research and Development Pharmaceutical Industries(EIG)Ukraine:Association of Pharmaceutical Research and Development(APRaD)27MEMBER COMPANIES Full MembersAbbVieAlmirall AmgenAstellasAstraZenecaBayer BiogenBoehringer IngelheimBristol Myers Squibb ChiesiCSL BehringCSL ViforDaiichi-Sankyo GileadGlaxoSmithKline GrnenthalIpsenJohnson&JohnsonLEO PharmaLilly MenariniMerckMerck Sharp&Dohme(MSD)Novartis Novo Nordisk Pfizer Pierre Fabre Roche Sanofi Servier TakedaTeva UCB Affiliate MembersBial EisaiJazz Pharmaceuticals LundbeckOtsuka Rovi Stallergenes Small&Medium-Sized Enterprises(SMEs)AC ImmuneAiCurisAM PharmaByondisENYO PharmaGenfitIdorsiaImcyseKuste BiopharmaMinoryxProQRSpexisSpero TherapeuticsTransgene EFPIANeo Building Rue Montoyer 51 1000 Brussels BelgiumTel.: 32(0)2 626 25 55www.efpia.eu infoefpia.euFurther details about the Federation and its activities can be obtained from:EFPIA(The European Federation of Pharmaceutical Industries and Associations)represents the research-based pharmaceutical industry operating in Europe.Founded in 1978,its members comprise 37 national pharmaceutical industry associations,40 leading pharmaceutical companies and 14 small and medium sized enterprises undertaking research,development and manufacturing of medicinal products in Europe for human use.EFPIA aims to create an environment that enables its members to innovate,discover,develop and deliver new therapies and vaccines for people across Europe,as well as contribute to the European economy.EFPIAs vision is for a healthier future for Europe.A future based on prevention,innovation,access to new treatments and better outcomes for patients.Through its membership,EFPIA represents the common views of about 2,000 large,medium and small companies including the entire European research-based pharmaceutical sector whose interests also include a significant part of the generics and biosimilars segments.Vaccines Europe(VE)is the specialised vaccine industry group within EFPIA.It represents major innovative research-based global vaccine companies as well as small and medium sized enterprises operating in Europe.
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REPORTEU-X-CT PUBLIC STAKEHOLDERS FORUM MAKING CROSS-BORDER ACCESSTO CLINICAL TRIALS A REALITYWEBSITEEU-X-CT C/O EFGCP https:/eu-x-ct.eu/eu-x-ctCreated by Oksana Latyshevafrom the Noun ProjectCreated by Oksana Latyshevafrom the Noun ProjectThe pan-European public-private EU-X-CT initiative aims to facilitate cross-border access to clinical trials.As a first step,we are collecting information on the regulatory,ethical,social security,liability insurance and organisational conditions for the involved stakeholders,as well as experiences and best practices in all European countries.At the Public Stakeholders Forum held in Brussels on April 12,2024,the national conditions for patients,clinical investigators,academia/public funders,and industry sponsors needing cross-border participation of patients in clinical trials were reviewed.The EU-X-CT leadership presented the initial results of the EU-X-CT gap analysis.This report summarises key insights from the meeting.INTRODUCTION2Table of ContentAcknowledgements.4Attendees.5Schedule.6Where we are today:Summary of session 1.8 Violetas experience as a caregiver and patient advocate.8 A caregivers and an investigators cross-border clinical trial experiences .10 Round table:Current experience with cross-border trial participation.11 Keynote:Overcoming borders will make Europe a more attractive place for clinical trials.12 The EU-X-CT gap analysis.13 Panel and Open Forum Discussion I.15Where we are today:Summary of session 2.18 PCM4EU&PRIME-ROSE:Cross-border access to pragmatic precision medicine trials.18 Industry experience with cross-border enrolment in rare diseases.19 The way forward:How to make progress in cross-border access to clinical trials?.20 How can EU-X-CT achieve the most urgent goals and how to make them sustainable?.22 Thank you.23 CONTENT TABLE3INITIATIVE LEADERSHIPWITH THE SUPPORT OFGOLDSILVERBRONZEACKNOWLEDGEMENTSTHE EU-X-CT THANKS ITS CONTRIBUTORS FOR THEIR CONTINUED SUPPORT4ATTENDEESParticipants joined from many different countriesIn-person meeting attendeesVirtual attendees#Country9Belgium6Czech Republic1Denmark6Estonia4Finland1France7Germany6Great Britain13Greece14Hungary2Ireland1Italy7South Korea7Luxembourg1Malta4Netherlands1Norway5Poland4Portugal2Romania11Serbia4Singapore1Slovakia11Slovenia1South Africa8Spain2Sweden1Switzerland1Turkey7Ukraine1USA149Total#Country1Austria15Belgium4Czech Republic1Denmark1Estonia4France5Germany1Greece1Hungary1Italy8Netherlands1Poland3Spain1Suomi4Sweden2Switzerland2United Kingdom55Total5SCHEDULE12 APRIL,2024SESSION 1:WHERE ARE WE TODAY?Welcome and Introduction to EU-X-CT Welcome from EFGCP and EFPIA Ingrid Klingmann,Pharmaplex,EFGCP Susan Bhatti,Merck BV,Chair CREG(EFPIA)Welcome from the academia membersJacques Demotes Mainard,ECRIN Welcome from the patient membersLisbeth Snede,Patients UniteRound table:Current experience with cross-border trial participationModerator:Lisbeth Oxholm Snede,Patients UnitePanelists:Michel Zwaan,Prinses Mxima Centrum voor kinderoncologie BVVioleta Astratinei,Melanoma Patient Network EuropeKeynote:Overcoming borders will make Europe a more attractive place for clinical trialsElmar Nimmesgern,European Commission DG R&IQ&AThe issues of cross-border access to clinical trials in Europe:The EU-X-CT gap analysis Moderation and Introduction:Susan Bhatti,Merck BVPresentations by Task Force leads:Maren Koban,Merck Healthcare KGaA Lisbeth Snede,Patient UniteMaja Pizevska,Berlin Institute of Health at Charit(BIH)Q&APanel and Open Forum Discussion:Is this picture accurate and comprehensive?Where are the assessment gaps?What other EU initiatives would benefit from improved cross-border access to clinical trials?Moderator:Solange Corriol-Rohou,AstraZenecaPanelists:Elmar Nimmesgern,European Commission DG R&IEmilie Prazakova,RocheJanek Kapper,Estonian Inflammatory Bowel DiseaseMarianne Lunzer,AGES,CTCG co-chairMichel Zwaan,Prinses Mxima Centrum voor kinderoncologie BVMonique Al,CCMO,CTCG co-chair,MedEthicsEU co-chair13:00Lunch10:0012:2010:2011:2010:5009:00Registrations&Welcome Networking Coffee6SCHEDULE12 APRIL,202414:0016:5014:3015:50SESSION 2:WHERE DO WE WANT TO GO?Enabling cross-border access to Clinical TrialModerator:Sabine Klger,ECRINPCM4EU and PRIME-ROSE-cross-border access to pragmatic precision medicine trialsBettina Ryll,Stockholm School of Economics Institute for Research and Melanoma Patient Network EuropeIndustry experience with Cross-Border Enrolment in Rare Diseases Joanna Sprague,ICONQ&AThe way forward:How do we make progress in cross-border access to Clinical Trials?Moderator:Bettina Ryll,Stockholm School of Economics Institute for Research and Melanoma Patient Network EuropePanelists:Begonya Nafria Escalera,Hospital San Juan de Du,eYPAGnetElmar Nimmesgern,European Commission DG R&IJacques Demotes Mainard,ECRINMarianne Lunzer,AGES,CTCG co-chairMonique Al,CCMO,CTCG co-chair,MedEthicsEU co-chairSusan Bhatti,Merck BV15:30BreakOpen Forum Discussion:How can EU-X-CT achieve the most urgent goals and how to make them sustainable?Moderators:Ingrid Klingmann,Pharmaplex,EFGCP and Susan Bhatti,Merck BVConclusions and next stepsIngrid Klingmann,Pharmaplex,EFGCP17:00End of meeting7WHERE ARE WE TODAYsummary of session 1Introduction to EU-X-CTEU-X-CT co-chairs Ingrid Klingmann and Susan Bhatti welcomed all participants on behalf of the chairing organisations EFGCP and EFPIA to the first public stakeholders meeting of the EU-X-CT initiative.Sabine Klger welcomed the participants on behalf of the academic community,and Lisbeth Snede welcomed the participants on behalf of the patient community.They emphasised the need to make Europe more attractive for clinical trials by enabling better cross-border access and the concrete action needed in the next couple of months to ensure the initiatives success.VIOLETAS EXPERIENCES AS A CAREGIVER AND PATIENT ADVOCATEVioleta shared her personal experience with cross-border trial participation as a caregiver to a melanoma patient and her professional experience as a patient advocate for melanoma patients.She shared her personal experience as a caregiver to her sister in Romania,who died of melanoma at the age of 51.She described seeking care abroad as difficult and“not a walk in the park.”The most support came from the Melanoma Patients Network Europe.As a result of her efforts,her sister was able to access a clinical trial in Germany and a compassionate use program in Brussels,Belgium.8 As a patient advocate with Melanoma Patients Network Europe,she had experience with patients from Ukraine who were forced to move to neighboring countries due to the war in Ukraine in 2022.One of the countries they moved to was Romania.However,there were challenges with the language and informed consent forms(ICFs)for the clinical trials in Romania.The speaker also mentioned that the sponsors and clinicians were concerned that the duration of the war would not align with patient participation in trials and that statistics would suffer.She concluded that clinical trials abroad are highly needed but come with financial,logistical,and mental burdens for cancer patients and caregivers.Occasionally,proactive,highly educated,and well-connected patients succeed in participating in clinical trials abroad,but this is not a sustainable or equitable solution.“I was surprised that despite all of this,her last words before she died,was whether there was anything more available for her out there,a clinical trial something to save her life.My sister had trust and hope that the research would benefit people like her.”Violeta AstratineiChallenges to cross-border clinical trial access:Only patients/caregivers with the education,language capabilities,and financial means are currently able to access clinical trials abroad.Identifying hospitals and investigators involved in the right clinical trial is very challenging.Hospitals sometimes cite lack of capacity as a reason for not accommodating patients from other countries.Certain hospitals even ask for a deposit from cross-border patients.Insurance companies cite the lack of regulations as a reason not to support cross-border participation.Getting medical data across borders is also a challenge,particularly once back in the home country.“If you have the financial means,then you can go with your money to Germany or Belgium and occasionally to Italy.But lately,some hospitals in Germany have started to ask for a deposit of 10,000 euros for trial participation.”Violeta Astratinei9Positive experiences:Negative experiences:Communication was not an issue here,as the two countries common language was Dutch.A translation of the informed consent form was not necessary There were cultural differences between hospital care in the two countries.However,it was a welcome change for the little girl.She was happy at the hospital in the Netherlands,which had a music studio and art facilities Also,unlike the hospital in Belgium,her father was taught how to give her the medication,which he appreciated There were issues with approvals from the Belgian health insurance,which was difficult as time was critical Transport from Belgium to the Netherlands was not easy,and the father had to make a bed in his car to move his daughter because an ambulance would have been too expensive Once Frederiks daughter started feeling better,the transition from the clinic to recovery outside the clinic was rapid,which led to some feelings of insecurity After being sent home to Belgium following a bone marrow puncture,the puncture site bled during the car ride,necessitating a visit to a Belgian hospital for further checks and an additional two-night stayA CAREGIVERS AND AN INVESTIGATORS CROSS-BORDER CLINICAL TRIAL EXPERIENCES Prof.Michel Zwaan,a Paediatric Oncologist at the Prinses Mxima Centrum voor kinderoncologie BV,and Frederik,the father of a paediatric patient,shared their first-hand experience with a cross-border trial.Frederiks daughter was a paediatric patient who was diagnosed with leukaemia in Belgium and initially treated there.However,she did not respond well and was then referred by her physician to the Prinses Maxima Centrum in the Netherlands,which had a suitable trial open(as the only site in EU).She responded well to the experimental treatment,but unfortunately passed away later following a transplant operation.10ROUND TABLE:CURRENT EXPERIENCE WITH CROSS-BORDER TRIAL PARTICIPATION Lisbeth Snede(Patients Unite)moderated the panel.The panellists included Michel Zwaan(Prinses Mxima Centrum voor kinderoncologie BV),Frederik,the father of a paediatric patient treated at Maxima,and Violeta Astratinei(Melanoma Patient Network Europe).The discussion revolved around their experiences with cross-border trial participation,focusing on data sharing,finding clinical trials,and the role of patient networks.Data sharing and continuity of care:Violeta shared her experience with data sharing during her time as a caregiver.She faced challenges in communication and transparency,particularly when moving CT scans and other medical data.She also highlighted the difficulty of managing toxicity after returning to their home country,as the treating physician was not familiar with the new drug used in the trial.Michel stressed the importance of physician involvement in data sharing and patient referrals by treating physicians.At Maxima,they only accept patients in clinical trials with the permission of the treating physicians to make sure that medical dossiers are shared directly between physicians.Finding suitable clinical trials:Frederick,the father of the paediatric patient,relied on the treating physician,while Violeta utilized a patient network(Melanoma Patient Network Europe),online research and her personal network to find the clinical trials.Michel stressed the importance of physician involvement in finding the right clinical trials for patients.As an example,he mentioned the establishment of an International Leukemia/Lymphoma Target Board at Maxima.This board allows physicians to present cases and discuss the best next steps with international experts.The panellists agreed that patient networks play a significant role in helping patients navigate clinical trials and make informed decisions.Actionable insights from the discussion:Systematically consider what can be done to improve the process of finding and matching patients to suitable clinical trials.Websites such as https:/clinicaltrials.gov/and the Europeanwww.clinicaltrialsregister.eu/and could help but are difficult for patients to use.11KEYNOTE:OVERCOMING BORDERS WILL MAKE EUROPE A MORE ATTRACTIVE PLACE FOR CLINICAL TRIALSElmar Nimmesgern(European Commission DG R&I)delivered the keynote address,which covered the regulatory framework for clinical trials in Europe,investments and partnerships in clinical research,and the relevance of cross-border access to clinical trials in Europe.Regulatory framework for clinical trials in Europe:The Clinical Trials Directive was approved by the European Commission to harmonize the conduct of clinical trials;however,there was divergence in how each Member State implemented it.To overcome this challenge,the Clinical Trials Regulation and the Clinical Trials Information System(CTIS)were introduced and became applicable in 2022.Elmar emphasised the complexity of harmonizing legislation among diverse EU member states.He believes the current framework benefits regulators and the industry by providing necessary guidance and encouraging the sharing of expertise.The ACT-EU partnership aims to improve the clinical trials environment in the European Union through harmonisation,innovation,and collaboration with stakeholders.European funding and partnerships in clinical research:The European Commission has invested almost 3 billion Euros in clinical research through the Horizon and European Research and Innovation framework programs,with nearly a billion Euros dedicated to clinical research.The ERA4Health program,in partnership with EU member states,launches calls for clinical trials and supports investigations.The program supports platform trials,a type of clinical trial design in which multiple treatments are evaluated simultaneously to accelerate clinical research.Cross-border clinical research in Europe:Elmar mentioned that the relevance of multi-country trials depends on the research question.Trials for more prevalent diseases,such as heart disease,can be done in a single country e.g.Germany An area where cross-border collaboration makes sense is rare diseases,which also include paediatric oncology.Paediatric oncology has demonstrated the importance of collaboration in clinical trials.The content of the European Health Data Space Legislation was recently agreed by the legislators.After formal approval and entry into application in the coming years,this legislation is expected to facilitate the portability of health data,making it easier for doctors across countries to access medical records.This could potentially aid in running cross-border registry trials.12THE EU-X-CT GAP ANALYSISEU-X-CT co-chair Susan Bhatti,along with task force leaders Maren Koban,Lisbeth Snede,and Maja Pizevska,presented initial results from the EU-X-CT surveys.Results from three surveys aimed at collecting information on legal,regulatory,and ethical aspects(survey 1),financial aspects,including patient liability coverage(survey 2),and aspects important to sponsors/CROs,investigators,and patients(survey 3)were presented.Survey methodologyThe EU-X-CT surveys are aimed to collect information on the following topics:1.Legal,regulatory,and ethics:National laws,regulations,Ethics Committee(EC)requirements 2.Financial:Health insurance and patient liability coverage(healthcare systems/insurers/payers)3.People and operational:Patient organisations,investigators,academia,and industry sponsors/CROsEU-X-CT approached a broad range of stakeholders,including regulatory affairs and clinical research experts in the pharma industry and contract research organisations as well as ethics committee members,insurance and healthcare system experts,investigators,academic institutions,patient organisations,and patients to collect data.Patient surveys were translated into all EU languages.Summary of results from the survey on legal,regulatory and ethical aspects(n=110)Legal and regulatoryEthics Cross-border clinical trial participation is generally not prohibited,and case-by-case participation seems to be feasible.Formal national legal/regulatory/ethical frameworks do not seem to exist for cross-border access to trials.Several countries(and the heads of medicines agencies)have issued national guidelines for cross-border clinical trial access for patients from Ukraine in the EU.There is a general lack of awareness;contradictory responses were obtained from certain countries.Country-level requirements are mainly determined by ECs and are often based on individual cases.EC approval may be required for cross-border clinical trial participation.Patient-facing material is generally required to be in the patients own language;translations/translators at sites might be required.ECs may have ethical concerns regarding travel burden,site follow-up of patients,differences in care between countries,and other practical aspects in a foreign setting.Patients may have to take up temporary(or even permanent)residence in the country of the trial.13Summary of results from the survey on legal,regulatory and ethical aspects(n=110)Summary of results from the survey on people and operational aspects(n=350)FinancialFeedback from patients and patient organisationsInsurance issues and cost coverage are key concerns(across surveys)as they are mostly not clearly defined:Costs of travel and/or baseline diagnostics and therapies at the country hosting the trial when not included in the trial site fees covered by industry or academic sponsors Coverage of additionally occurring costs such as adverse-event-related medical care or long-term baseline medication needed in the trial in the patients home country between their study visits Coverage of healthcare costs incurred in the patients home country after participating in a trial conducted in a different country.Liability insurance coverage for damages occurring to cross-border patients back home is typically not included in the trial sites insurance.Participating in a clinical trial in the US presents fewer administrative hurdles(in addition to more trial options)compared to Europe.Difficulty in accessing trials due to financial constraints:Instances where patients are required to cover substantial out-of-pocket expenses,even when general health insurance coverage is available.Logistics and administrative challenges:Obtaining the necessary forms for health cost coverage and registration for medical attention in public hospitals can be cumbersome and time-consuming.Uncertainties in legal and insurance aspects:Processes not clear for cross-border participants.Difficulty in obtaining answers to any open questions:Leading to a cautious approach to cross-border participation.Very limited feedback indicates the lack of information on healthcare costs and insurance/liability beyond a few individual experiences(information on financial aspects were voluntarily offered in response to the other surveys e.g.,legal/ethical,investigator,and patient surveys.)Summary of the interim analysis of the surveys 490 responses were received:110 for survey 1,27 for survey 2,and 350 for survey 3.Cross-border trials are not explicitly forbidden in any country.However,the lack of clarity and specific legal and regulatory guidance leads to a very cautious approach to cross-border participation for major stakeholders(sponsors,investigators,patients).Cross-border access is currently managed on a case-by-case basis and is associated with a high logistical and administrative burden(if not entirely covered by industry trial sponsors).Who pays for what is the most critical issue.Access to insurance coverage is needed,also for background treatment and trial-related injuries.Travel and accommodation costs can mean potentially high upfront out-of-pocket expenses for patients.14PANEL AND OPEN FORUM DISCUSSION I Language barriers might impact a patients ability to understand risks.Patients must be able to make an informed decision about joining the trial.There are also concerns about cultural differences in healthcare practices,the burden of frequent relocation for patients,and the potential impact on a patients decision regarding risk.Decentralised trial elements across border may not be feasible in certain countries,although they might be the best option for patients.Solange Corriol-Rohou(AstraZeneca)moderated the panel discussion.The panellists included Elmar Nimmesgern(European Commission DG R&I),Emilie Prazakov(Roche),Janek Kapper(Estonian Inflammatory Bowel Disease),Marianne Lunzer(CTCG co-chair,AGES),Michel Zwaan(Prinses Mxima Centrum voor kinderoncologie BV)and Monique Al(CTCG co-chair,CCMO,and MedEthicsEU co-chair).Role of ethics committees in cross-border trials and the possibility of a central ethics committee review:The panellists discussed the role of ethics committees in cross-border trials,and the topic of creating a European central ethics review body for clinical trials.Monique mentioned that such a possibility is currently explored as part of ACT-EU by the MedEthicsEU group that she co-chairs and that they are looking into the pros and cons and trying to determine the hurdles.Michel offered a nuanced perspective,acknowledging the potential benefits of a central ethics committee approval for streamlining processes,but also raising concerns about potential language and cultural barriers.He suggested that a template,adaptable to local contexts,could be a useful solution.Marianne mentioned that differences in national treatment standards might be more easily overcome in rare or ultra-rare diseases because,most of the time,the standard of care might not simply exist across Europe.Role of regulators in cross-border trials:The regulators in the panel emphasised the need for a pragmatic approach to single vs.multi-country trials.There is a need for clear planning and a clear concept for cross-border approaches.If there is a clear motivation,it should be reflected in the protocol upfront and planned upfront so as not to surprise regulators with ad hoc needs for quick intervention.Monique suggested that we dont need more regulations and laws but need a pragmatic approach with more guidance and clarity.Marianne commented that the default expectation should be that patients receive care where they live.However,if there is only a centre of excellence abroad,this is a good reason for cross-border participation.15Pros and cons of single vs multi-country trials:Several panellists criticized one-centre trials,arguing that access to trials should not be limited to well-resourced,well-equipped Western European centres.Michel highlighted the enormous administrative burden on larger centres and investigators in single-country trials receiving patients from across Europe.He suggested that there should be an obligation to open more centres in Europe for rare diseases,and in the case of single-centre trials,the sponsors should pay for patients cross-border travel and other costs.Finding clinical trials:The panellists emphasised the importance of clear and accessible information about potential trials of interest.They suggested regulators could play a role in ensuring that information about clinical trials is clear,available in the patients language,suitable for a layperson,and correctly entered into databases.Information needs to be reliable and robust.This would help patients find clinical trials that are relevant to them and make informed decisions about their participation.“If your intervention is so complicated that no one else will be able to do it,then this would be a clear motivation for a single site and for a cross-border approach And if there is a clear motivation reflected in the protocol upfront,plan it upfront,dont surprise us with ad hoc needs for quick interventiontime is critical most of the time in many diseases,so clear planning and a clear concept would be beneficial for the patients.”Marianne Lunzer“If you have a rare disease,such as in paediatric oncology there should be an obligation to open more countries in Europe,because you have to find these patients.And if you decide not to do that,maybe there is an obligation to pay for the cost.”Michel Zwaan16Safety of patients between study visits and continuity of care in the home country:A participant raised concern about ensuring proper care for patients participating in clinical studies outside their home country.It is crucial to consider the safety of patients participating in clinical trials,especially at home between study visits.Once the patient returns to the home country,local doctors may lack the necessary information to handle adverse events or toxicities.Michel shared this concern and acknowledged the difficulty of maintaining open communication with the patients local physician and monitoring their condition between visits.He mentioned the efforts to provide the local physician with information about potential side effects and 24/7 contact for emergencies.However,he admitted that this is a challenging process that takes time.He emphasised the importance of having these measures in place before sending a patient home,considering the potential need for the patient to stay for extended periods in a foreign country for the study.Insurance issues:Michel pointed out that the insurance and healthcare coverage issues in the patients home country are difficult to solve and require a lot of time spent by investigators.Emilie mentioned that access across Europe to clinical trials needs to be available for all EU citizens and not just those with money,connections and the ability to understand English.Patients need support to navigate administrative hurdles as well as people to support them overcome the cultural and practical challenges in the country where the trial site is located.The role of clinical trial ambassadors and patient organisations:A participant introduced a clinical trial ambassadors programme in Europe consisting currently of 52 clinical trial ambassadors and their numbers are increasing.Patient organisations are encouraged to have a clinical trial ambassador trained to provide patients with information about clinical trials and help them find suitable ones.The panellists also discussed the importance of translating information about clinical trials into local languages and sending it to specific disease associations.17WHERE ARE WE TODAYsummary of session 2PCM4EU&PRIME-ROSE:CROSS-BORDER ACCESS TO PRAGMATIC PRECISION MEDICINE TRIALSBettina Ryll,from the Stockholm School of Economics Institute for Research and the Melanoma Patient Network Europe,introduced two Horizon Europe Mission on Cancer-funded projects:PCM4EU and PRIME-ROSE,and the challenges and motivations for cross-border clinical trial participation in Europe.DRUP-like clinical trials run under the PCM4EU and PRIME-ROSE projects:PCM4EU and PRIME-ROSE aim to provide Europe-wide access to precision medicine for cancer patients.While PCM4EU focuses more on the diagnostic side,PRIME-ROSE focuses on setting up joint cohorts for clinical trials.The clinical trials run under the projects called DRUP-like clinical trials are independently organized academic trials that were inspired by the original Dutch Drug Rediscovery Protocol(DRUP)protocol used for research on repurposing of authorised medicines for new indications.One goal of such a trial methodology is equitable access to clinical trials in cancer precision medicine across Europe.Cross-border trial participation was considered a solution to the issue of access to these trials.However,currently,they are focussing on a different,more pragmatic approach that combines harmonisation at the European level with local independence.The goal is to have one master agreement at the European level for everyone connected,which will then be ratified at the national level independently.Currently,most active trials are in Western Europe but are slowly expanding to Eastern Europe.The speaker highlighted Norway as a good example of how equitable access can be made practical.Norway has connected all its clinical centres to a National Molecular Tumour Board,where any patient in the country,regardless of where they are,has access to the same quality and service.This is an example of a truly inspiring structure in which other countries are following suit.The setting up of a European National Tumour Board is under discussion.18Cross-border trial setup for a rare disease clinical study:Pre-screening and recruitment:The case study involved recruiting of around 50 babies for a rare disease study.Due to the nature of the disease and the lack of treatment options in home countries,the parents/carers were very motivated to join the study.Pre-screening for the study was done by collecting and reviewing various details such as diagnosis,language skills,passport status,visa requirements,and willingness to travel while ensuring patient confidentiality and then matching patients to a site based on their requirements,preferences,and location.Nearly all the study participants were recruited across borders,both within and outside the EU.Ethics committees:The study team created and submitted a proposal document to different ethics committees,which included details on the justification for recruitment,pre-screening and consent,maintenance of confidentiality,insurance coverage,logistics,patient support,patient documentation,and post-study support.Ethics committee requirements and involvement varied.Logistics and language:The sponsor paid for travel and lodging for the patient and their parent/caregiver,and a third-party vendor was contracted to arrange the logistics.This vendor served as a confidentiality buffer between the sponsor and the patients,handling logistics without disclosing personal identifiers.It also proved beneficial in addressing language and cultural issues.The sponsor also paid for a patient liaison to support the patient with language and cultural issues.Informed consent:The patients parents and investigator were required to sign the Informed Consent Form(ICF)in their language,with an interpreter also signing as an impartial witness.Additionally,caregivers were asked to bring copies of source data,which were then verified by a Clinical Research Associate fluent in that language.Insurance:International travel insurance was arranged for patients traveling between countries,and they were advised to carry their European Health Insurance Card(EHIC)if they were within the EU.IP shipment:The shipment of investigational products was found to be easier within the EU but posed logistical challenges outside of it.Successful cross-border clinical trial participation was mainly in paediatrics or when pharmaceutical companies set it up.Success was also found where there was established contact between two or more institutions,and in border regions.The speaker gave the example of an initiative between two institutions,one in Portugal and the other in Spain,where clinicians work together and coordinate the movement of patients back and forth.Motivation is particularly high in border regions,where potential trial patients may live on the other side of the border.Bettina gave the example of an initiative in Ireland working across the border with the UK.Cross-border trials in various European regions where are they happening:“At the moment,it relies too much on single individuals.individuals who can make it work.We need everyone.and the trial to the patient is a better solution than the patient to the trial,and borders should no longer be barriers.”Bettina RyllINDUSTRY EXPERIENCE WITH CROSS-BORDER ENROLMENT IN RARE DISEASESJoanna Sprague(ICON)shared experiences with cross-border enrolment for a rare disease clinical trial from a CRO perspective.19The key learnings from the case study and suggestions for cross-border trial conduct:The study team should anticipate the possibility of cross-border recruitment,prepare accordingly,and educate the entire team about its potential and impact.Discuss the potential for cross-border recruitment with sites early on during pre-study site selection visits,assessing their willingness and ability to receive patients from other countries.Considerations include staff availability,technology,infrastructure,and the ability to manage the transfer of medical records and accommodate non-native language speakers.Engage with ethics committees early in the process,addressing the possibility of cross-border recruitment during initial applications in a proposal document to be shared prior to the actual application.For instance,through a phone call,if possible,before submitting the documents.Some ethics committees may require approval while others only want notification.Use pre-screening to identify suitable patients and ensure confidentiality is kept until consent is obtained.Recommend using a vendor to sort out insurance,travel,and lodgings for patients.Explore the use of decentralised clinical trials to facilitate cross-border recruitment.This approach,which involves remote patient monitoring and treatment,is showing promise within countries and could potentially be applied across borders.Consider the steps needed to ship investigational products across borders on an ongoing basis,particularly for patients with chronic illnesses.This aspect was not covered in the case study but is an important consideration.Cross-border trials are feasible,and various elements are already in place to facilitate them.The challenge is to know about options,to connect the available dots,leveraging the existing resources and initiatives.Providing guidance to Member States by showcasing a few examples,would be a pragmatic first step towards a solution.Reducing uncertainty would help reduce the administrative burden.A pragmatic approach to cross-border access to clinical trials:THE WAY FORWARD:HOW TO MAKE PROGRESS IN CROSS-BORDER ACCESS TO CLINICAL TRIALS?The panel discussion was moderated by Bettina Ryll(Melanoma Patient Network Europe)and panellists were:Begonya Nafria Escalera(Hospital San Juan de Deu and eYPAGnet);Elmar Nimmesgern(European Commission DG R&I);Jacques Demotes Mainard(ECRIN);Marianne Lunzer(AGES,CTCG co-chair);Monique Al(CCMO,CTCG co-chair,MedEthicsEU co-chair)and Susan Bhatti(Merck BV).All shared views on how to tackle the issue of cross-border clinical trial access.20“Im questioning.Do member states even have a guidance of their own with respect to cross border research?Somebody says no.What is the basis of their response?I think a first step would be to make an inventory if there is guidance.And if you have a guidance,what does it mean?Where can we harmonize things?I think harmonisation is the keyword,but its also challenging.”Bettina Ryll“When a commercial sponsor is actually setting the trial up,there is money available.we want to have involvement in our trials.the key thing is the preparation and making sure that you have reached out to the sites,to the patients,to patient organisations,to ethics committees,and basically told them upfront that there might be a necessity to do this so that people are not surprised and suddenly put under pressure to approve something”Susan Bhatti A need for better preparation:The potential of decentralised clinical trials(DCTs):The need for better harmonisation and standardisation:The challenges of language and cultural differences:The importance of a risk-appropriate approach:Several panellists mentioned the importance of preparing for cross-border access to clinical trials,including reaching out to sites,patients,patient organisations,and ethics committees in advance The panellists suggested that using decentralised trial elements,such as remote monitoring,digital consent,and home delivery of treatments,could facilitate cross-border access and reduce the burden on patients.They also emphasised the need to raise awareness among patients and patient organisations about the possibilities and benefits of decentralised trials,as well as the existing guidance and tools for finding and participating in them.A successful DCT involving COVID patients in the UK was mentioned.The panellists discussed the importance of agreeing on standards,processes,and infrastructure to facilitate cross-border access to clinical trials.Some panellists mentioned the challenges posed by language and cultural differences and the need to ensure that language is not used as an exclusion criterion.They also discussed the need to translate and validate informed consent forms,questionnaires,and other materials.Several panellists emphasised the importance of a risk-appropriate approach to cross-border access to clinical trials,where risks are identified,managed,mitigated,or simply accepted.21HOW CAN EU-X-CT ACHIEVE THE MOST URGENT GOALS AND HOW TO MAKE THEM SUSTAINABLE?EU-X-CT co-chairs,Ingrid Klingmann and Susan Bhatti,presented a 6-point action plan based on the results of the EU-X-CT gap analysis and the multi-stakeholder discussions at the Public ForumTo work out the minimal ethics committee requirements for cross-border participation in clinical trials in collaboration with MedEthicsEU.To develop a set of recommendations for industry and academic sponsors as well as CROs,on how to approach cross-border trials in their protocols,when to inform the relevant ethics committees about the planned conditions,and how to prepare and support sites for hosting patients from abroad.To develop a set of recommendations for investigators and sites on aspects they need to clarify when wanting to host patients from abroad.To reach out to payers and health insurance companies to get clarity on the cost coverage of cross-border trial participation.To clarify with liability insurance companies how damages occurring to the patient in his/her home country could best be covered.To raise awareness among patients and treating physicians about the option of cross-border participation in clinical trials.Establishing national contact points for patients was also suggested.12345622THANK YOUAll speakers and participants of the EU-X-CT Public Forum 2024All EU-X-CT members and collaboratorsEFGCP and EFPIAEU-X-CT sponsorsEU-X-CT Public Forum Programme CommitteeEFGCP SecretariatReport written by Dr.Roshini Beenukumar(Medical Writer)based on notes taken during the meeting and recordings of the talks.Summaries reviewed by Dr.Susan Bhatti and Dr.Ingrid Klingmann.23EU-X-CT PUBLIC STAKEHOLDERS FORUM MAKING CROSS-BORDER ACCESSTO CLINICAL TRIALS A REALITYCrowne Plaza Brussels AirportDa Vincilaan 4,1831 DiegemBelgiumContact usWEBSITEEU-X-CT C/O EFGCP https:/eu-x-ct.eu/eu-x-ct
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Understanding pharmaceutical innovation to improve access to new treatmentsSpecial Edition EU Pharmaceutical Legislation ReformPharmaceutical POLICY PASSPORTINVENTING FOR LIFEMSD IS A LEADING BIOPHARMACEUTICAL COMPANY THAT FOCUSES ON CUTTING-EDGE RESEARCH TO SAVE AND IMPROVE LIVES GLOBALLY.OUR MISSION IS TO HARNESS THE POWER OF SCIENCE TO ADVANCE THE PREVENTION AND TREATMENT OF DISEASES IN HUMANS AND ANIMALS.FOR MORE THAN 130 YEARS,WE HAVE BROUGHT HOPE THROUGH THE DEVELOPMENT OF IMPORTANT MEDICINES AND VACCINES.TODAY,WE ARE AT THE FOREFRONT OF RESEARCH TO DELIVER INNOVATIVE HEALTH SOLUTIONS THAT ADVANCE THE PREVENTION AND TREATMENT OF DISEASES IN PEOPLE AND ANIMALS.TO LEARN MORE ABOUT MSD,PLEASE VISIT OUR WEBSITE AT MSD.COMMSD POLICY PASSPORT3A KNOWLEDGE-BASED ECONOMYINVENTING FOR LIFEWHY APOLICY PASSPORT?At MSD,we believe that pharmaceutical innovation is the result of a sophisticated policy framework that supports science,healthcare,and industrial policy focused on building a knowledge economy.EU institutions and national governments play a key role in the creation and sus-tainability of our research and innovation ecosystem.They do so by investing in fun-damental science,financing healthcare,and providing incentives to attract private sector investment in pharmaceutical innovation.This web of public policies provides the con-ditions for pharmaceutical companies such as MSD to invest and develop innovative treat-ments that benefit patients and societies.1 EFPIA,The Pharmaceutical Industry in Figures Key Data 2023.In 2021 alone,research-based pharmaceuti-cal companies have invested an estimated 42,5billion in R&D in Europe.12As the EU is embarking on a comprehen-sive reform of its general pharmaceutical legislation,our Policy Passport is intended to provide policy makers and other stake-holders with a“roadmap”of the drivers and critical policies that support pharmaceutical innovation.I want to thank my team at the MSD Brussels Policy Centre for producing this Policy Passport,with very special thanks to Boris Azas,Director Public Policy.David Earnshaw,Associate Vice-PresidentMSD Brussels Policy CentreIN THE EU,WE HAVE THE SCIENCE,THE HEALTH SYSTEMS,AND THE PHARMACEUTICAL COMPANIES TO PROVIDE BETTER HEALTH TOOUR CITIZENSMSD POLICY PASSPORT4A KNOWLEDGE-BASED ECONOMYINVENTING FOR LIFETABLE OF CONTENTSCONTACTBrussels Policy CentreRond-Point Schuman 61040 BrusselsFor questions or comments on the Policy Passport,please contact Boris Azas here.MSD 2024Second edition,version 3 dated April 2024.A KNOWLEDGE-BASED ECONOMY The societal value of pharmaceutical innovation Pharmaceutical innovation policy Policy makers are in the driving seat Regaining EU global leadership R&D improves lives R&D promotes growthTHE SOURCE OFINNOVATION What drives pharmaceutical innovation?The long road from bench to bedside From theory to therapy Public and private research are complementary It takes a village We dont rest A risky business The critical role of incentives Future-proofing drug approval Agile regulatory processVALUE OFINNOVATION Innovation is what helps the patient Prevention is better than cure Bending the curve of cancer Our fight against cancer Orphan medicines for millions of patients Value for money Healthy animals make for healthy peopleHEALTH COSTS Why do health costs increase?Disease is the real cost,not the treatment Heavy focus on drug budgets Money well spentPHARMACEUTICAL EXPENDITURES How much do we spend on drugs?Share of drug spending Drug spending is stable as a share of health budgets The public price is not what the public pays International price comparison The unintended consequences of price transparency Reward value to the patient Health technology assessment Value-based pricing is patient-centricSPECIAL CHALLENGES The global health threat of antimicrobial resistance A new incentive to fight microbes Addressing medicine shortages Faster patient access Electronic product informationBEYOND INNOVATION MSD for mothers Nobody left outside Health literacy About MSDClick on any topic below to access its page.Click on the icon featured at the top of each page to return to this table of contents.MSD POLICY PASSPORT5A KNOWLEDGE-BASED ECONOMYINVENTING FOR LIFEPharmaceutical innovation is one of the driv-ing forces behind the tremendous progress in life expectancy and better health we have experienced in the last 60 years.After clean water and sanitation,the de-velopment of novel health technologies by pharmaceutical companies has been akey driver of healthier and longer lives.11 Frank R.Lichtenberg,The Impact of New Drug Launches on Longevity:Evidence from Longitudinal,Disease-Level Data from 52 Countries,19822001.International Journal of Health Care Finance and Economics,2005.Antibiotics,vaccines,cardiovascular medi-cines,diabetes medicines,antiretrovi-rals against HIV/AIDS,hepatitis C cures,and breakthrough cancer medicines are some of the many treatments discovered by pharmaceutical companies that have helped us achieve significant progress in healthcare.BUT WHAT DRIVES PHARMACEUTICAL INNOVATION?How do we make the link between funda-mental science and a medicine or vaccine that will deliver better health?EU leaders are at the source of the legislation that supports the long pathway between a sci-entific discovery and the prescription filled for a patient at apharmacy.THE SOCIETAL VALUE OF PHARMACEUTICAL INNOVATIONPOLICY MAKERS PLAY ACRITICAL ROLE IN STRENGTHENING THE EU LEADERSHIP IN PHARMACEUTICAL INNOVATIONMSD POLICY PASSPORT6A KNOWLEDGE-BASED ECONOMYINVENTING FOR LIFEGLOBAL LEADERSPHARMACEUTICAL INNOVATION POLICYINDUSTRIALPOLICYINVEST IN SCIENCEHIGHER EDUCATIONACADEMIC LEADERSHIPACCESS TO NEW TREATMENTSADDRESS UNMET NEEDSIMPROVE POPULATIONHEALTHPATENT RIGHTSPHARMACEUTICALINNOVATIONNAVIGATING A COMPLEX POLICY FRAMEWORKJOBS&GROWTHSCIENCE POLICYHEALTHPOLICYMSD POLICY PASSPORT7A KNOWLEDGE-BASED ECONOMYINVENTING FOR LIFETHREE POLICY PILLARSPOLICY MAKERS ARE IN THE DRIVING SEATInvestmentin Science Higher education Academic centres BioclustersInnovation-Friendly Policies Intellectual property Agile regulatory system Push/pull incentivesInvestmentin Healthcare Patient centered care Value-based pricing Rapid accessHEALTHCAREPOLICYINDUSTRIALPOLICYSCIENCEPOLICYDRIVEPOLICY OUTCOMESNEW TREATMENTSBETTER HEALTH SUSTAINABLE HEALTH SYSTEMS HIGHER PRODUCTIVITY ECONOMIC GROWTH AND JOBS.R&D.NEW DRUGS.RAPID UPTAKE.SALES.CASHFLOWRESULTING INMSD POLICY PASSPORT8A KNOWLEDGE-BASED ECONOMYINVENTING FOR LIFELOCATION OF PHARMACEUTICAL COMPANIES R&D EXPENDITURE 2001-2020INVESTING IN RESEARCH AND INNOVATION IS INCREASINGLY CRUCIAL FOR SHAPING ABETTER EUROPEAN FUTURE IN ARAPIDLY GLOBALISING WORLD,WHERE SUCCESS DEPENDS EVER MORE ON THE PRODUCTION AND CONVERSION OF KNOWLEDGE INTO INNOVATION.Pascal Lamy,Investing in the European future we want,Report of the High Level Group on EU Research&Innovation Programmes,2017.REGAINING EU GLOBAL LEADERSHIPThe research-based pharmaceutical industry is one of the leading high-tech sectors in Europe.1 While it remains a leading source of new medicines and vaccines globally,Europe has been losing ground against its main competitors.Twenty years ago,the amount of investment made by pharmaceutical companies in R&D in the US and Europe differed by only 2 billion.By 2020,pharma-ceutical companies R&D investment in the US exceeded the amount spent in Europe by almost 25 billion.2 200120052010201520207065605550454035302520151050CAGR 5.78GR 3.75GR 2.47GR 20.38%U.S.EU UK,CHJapanChina*CAGR(Compound Annual Growth Rate)is the average rate of growth accross a number of years1 EFPIA,The Pharmaceutical Industry in Figures-Key Data 2023.2 EFPIA,Europes share of global medicines R&D shrinks by a quarter in 20 years as sectors declining trends continue,7 November 2022.As a knowledge-based economy,Europe can regain its global leadership,provided that we continue to invest in science and in healthcare,and maintain a competitive incentive framework.Source:Charles River Associates,Factors affecting the location of biopharmaceutical investments and implications for European policy priorities,Figure 1,November 2022.MSD POLICY PASSPORT9A KNOWLEDGE-BASED ECONOMYINVENTING FOR LIFESince 1950,more than 1,800 new drugs have been approved.1 This wave of innovation has played a key role in the steady increase in life expectancy.In the last decades,innovative medicines are estimated to have contributed up to 73%of the increase in life expectancy at birth after accounting for other factors.2Over decades,research-based pharmaceu-tical companies have developed innovative medicines and vaccines across a broad range of diseases representing most of the burden of disease(cardiovascular,cancer,HIV/AIDS,diabetes,etc.)1 Kinch et al.,An Overview of FDA-Approved New Molecular Entities(NMEs):18272013,Drug Discovery Today,2014.Updated with FDA CDER,New Drug Therapy Approvals 2022,January 2023.2 See Frank Lichtenbergs papers:(a)The Impact of New Drug Launches on Longevity:Evidence from 52 Countries,19822001,International Journal of Health Care Finance and Economics,2005;(b)Pharmaceutical innovation and longevity growth in 30 developing OECD and high-income countries 20002009,Health Policy&Technology,2012;(c)The effect of pharmaceutical innovation on longevity:Evidence from the US and 26 high-income countries,Economics&Human Biol.,2022.3 European Society of Medical Oncology,One in Two Patients with Metastatic Melanoma Alive after Five Years with Combination Immunotherapy,28 Sep 2019.For example,the 5-year survival rate of metastatic skin cancer went from less than 5%to over 50%thanks to innovative treatments.3 Pharmaceutical innovation also brings additional health benefits by releasing other healthcare resources-e.g.,HIV/AIDS treat-ments freeing up hospital wards,hepatitis C cures lowering the need for liver transplants or HPV vaccination preventing cervical cancer.CONTRIBUTION OF INNOVATIVE MEDICINES TO INCREASE IN LIFE EXPECTANCYLONGER LIFE THROUGH NEW MEDICAL INNOVATION IS THE LAST CENTURYS GREATEST GIFT.Nobel Prize-winning economist Gary Becker.R&D IMPROVES LIVES 1.27years73%Source:Lichtenberg F.,Pharmaceutical innovation and longevity growth in 30 developing OECD and high-income countries 20002009,Health Policy&Technology,2012.“Pharmaceutical innovation increased life expectancy by 1.27 years during 2000-2009.”Prof.Frank LichtenbergMSD POLICY PASSPORT10A KNOWLEDGE-BASED ECONOMYINVENTING FOR LIFEOver 2.5 million jobs are supported by the pharmaceutical sector in Europe both directly and indirectly.1,2 In 2021,pharmaceutical companies invested an estimated 41.5billion in R&D in Europe,making it the sector with the highest ratio of R&D investment to net sales in the EU about 46ove the ICT sector,which ranks second.1 1 PwC/EFPIA,Economic and societal footprint of the pharmaceutical industry in Europe,June 2019.2 EFPIA,The Pharmaceutical Industry in Figures Key Data 2022.According to EUROSTAT,the pharmaceutical industry is the high-tech sector with the highest added value per employee,and con-tributed 136 billion to the EU trade surplus in 2021.2THE TRADE SURPLUS IN PHARMACEUTICAL AND MEDICINAL PRODUCTS GREW FROM 18 BILLION IN 2002 TO A RECORD HIGH OF136BILLION IN 2021.EUROSTAT,International trade in medicinal and pharmaceutical products,Data from March 2022.3EU-27 TRADE BALANCE HIGH TECHNOLOGY SECTORS Million 2021R&D PROMOTES GROWTH Medical&Pharmaceutical products(STIC 54)Power generating machinery and equipment(STIC 71)Office machines&automatic data processing machines(STIC 75)Telecommunication,sound-recording&reproducing apparatus&equipment(STIC 76)Electrical machinery,apparatus&appliances(STIC 77)Professional,scientific&controlling instruments&apparatus(STIC 87)Source:Eurostat,COMEXT database,May 2022135,6333 According to updated EUROSTAT data,“the EUs trade surplus in medicinal and pharmaceutical products reached 175 billion in 2022.”MSD POLICY PASSPORT11A KNOWLEDGE-BASED ECONOMYINVENTING FOR LIFETHE SOURCE OFINNOVATIONOver the course of 25 years,the field of viral hepatitis advanced from discovery of the virus to the beginning of the curative era for HCV infection.John Ward,Hepatitis C virus:The 25-year journey from discovery to cure,Hepatology,August 2014.THE SOURCE OF INNOVATIONMSD POLICY PASSPORT12INVENTING FOR LIFEUNMET MEDICAL NEEDSSCIENTIFICRESEARCHENTREPRENEURSHIPWHAT DRIVES PHARMACEUTICAL INNOVATION?Pharmaceutical innovation is at the junction of scientific advances,unmet medical needs,and entrepreneurship.These drivers are shaped by governments through strong enablers,such as intellectual property rights(to secure capital to conduct R&D),and healthcare systems(to ensure uptake of new treatments).This policy mix allows companies to engage in high-risk and high-cost research and development activities.DRIVERSENABLERSPUBLIC-PRIVATE PARTNERSHIPSAGILE REGULATORY SYSTEMRAPID PATIENT ACCESSR&DINCENTIVESTHE SOURCE OF INNOVATIONMSD POLICY PASSPORT13INVENTING FOR LIFETHE LONG ROAD FROM BENCH TO BEDSIDESCIENTIFIC DISCOVERYHIGH-THROUGHPUT SCREENINGCOMPOUND IDENTIFICATION AND IMPROVEMENTDATA COLLECTION&ANALYSISCHEMICAL DESIGN COMPUTATIONAL DISCOVERYRESEARCHDEVELOPMENTAPPROVALCONTINUE TO STUDY THE MEDICINEMARKETING APPROVALHUMAN TESTINGCOMPOUND DESIGN&SYNTHESISCLINICAL TRIALSSAFETYPHASE IV TRIALSREAL-WORLD DATANEWINDICATIONSPRICING AND REIMBURSEMENTAND ALL THIS TAKES ON AVERAGEDiMasi J.,Gabrowski H.,Hansen R.,Innovation in the pharmaceutical industry:new estimates of R&D costs.J Health Economics,2016.EFFICACYUSD 2.6b converted from USD at August 2023 rateTOLERABILITYDOSINGTHE SOURCE OF INNOVATIONMSD POLICY PASSPORT14INVENTING FOR LIFEINVENTING FOR LIFEAPPLIEDFROM THEORY TO THERAPYFrom a scientific paper to a medicine that saves lives,public and private research laboratories play a complementary role in a series of increasingly expensive bets spanning several decades.1 First comes the science.To develop a new treatment,we need to understand human biology and disease mechanisms.Once we have a working theory,we enter into the realm of applied research to translate scientific insights into new medicines.This is where scientific papers are put to the test-starting with trying to replicate their findings.The journey from hypothesis to a novel therapy requires major involvement of industry,as it possesses the expertise and resources unavailable in academia.2 We can debate endlessly which is more im-portant between basic and applied research.But when it comes to drug development,we need both.We will never treat people with a scientific paper,and we cannot look for a therapy without understanding the disease.1 For an illustration,see Dolin E.,The tangled history of mRNA vaccines,Nature,14 September 2021.2 Flier J.,Academia and industry:allocating credit for discovery and development of new therapies,Journal of Clinical Investigation,20 May 2019.Basic and applied research are comple-mentary and also inform each other.Drug development operates at the frontier of our scientific knowledge.The repeated failures in the last decade of promising compounds against Alzheimers disease have provided important insights in the amyloid hypoth-esis on which these R&D programmes were based.PHARMA COMPANIES DO MOST OF THE RESEARCH TO TRANSLATE BASIC SCIENCE INTO NEW MEDICINES.2INVENTING FOR LIFEOUR STUDY SHOWED THAT 23,230 NIH GRANTS MADE IN 2000 WERE LINKED TO 18 APPROVED MEDICINES BY 2020.TOTAL PRIVATE INVESTMENT FOR THE 18 APPROVED MEDICINES WAS US$44.2 BILLION COMPARED TO US$670 MILLION IN NIH FUNDING.Vital Transformation,Who Develops Medicines?An Analysis of NIH Grants,May 2021.ApprovalClinical development(human trials)Drug discovery(identify and improve leading molecules)TargetidentifcationHitidentifcationHit-to-leadLeadoptimisationPreclinicaldevelopmentPhase 1Phase 2Phase 3Large biopharmaceutical companiesSmall biopharmaceutical companiesPublic and academic institutionsFocus of execution:HighLowSource:LEK,Rand Europe&SiRM,The financial ecosystem of pharmaceutical R&D,February 2022.THE SOURCE OF INNOVATIONMSD POLICY PASSPORT15INVENTING FOR LIFEPUBLIC AND PRIVATE RESEARCH ARE COMPLEMENTARYLets use an analogy:if disease is like a closed door,basic research is focused on finding the lock that opens the door,and then describes how it works in scientific publications.Once we have a working theory,private sector starts searching for a key that could safely open the door,ie,a therapeutic that patients can use.In practice,pharmaceutical companies also conduct basic research.They also assess if published research can be replicated to check if this is really“the lock that will open the door.”This is an important step before engaging in costly R&D,considering that “a majority of published findings could not be reproduced.”1For more on the role of public and private sector,please see Derek Lowe,Where Drugs Come From:A Comprehensive Look,Science,May 2019,and Jeffrey S.Flier,Academia and industry:allocating credit for discovery and development of new therapies,J Clin Invest.,2019.FROM 2013 TO 2019,WE FOUND THAT BIOPHARMACEUTICAL R&D EXPENDITURE BY THE PRIVATE SECTOR ACROSS COUNTRIES IS ON AVERAGE 82%GREATER THAN PUBLIC SECTOR SPENDING.Charles River Associates,The Roles and Synergies of Public and Private Investment in European Medicines Research and Development,2023(publication pending).BASIC SCIENCEWhere is the lock?Lets see how it works!PHARMACEUTICAL RESEARCHCan we open this?Lets find a key!DISEASE1 Kannt A.,Wieland T.,Managing risks in drug discovery:reproducibility of published findings,Naunyn-Schmiedebergs Arch Pharmacol,2016.THE SOURCE OF INNOVATIONMSD POLICY PASSPORT16INVENTING FOR LIFEIT TAKES A VILLAGEBETTER HEALTH FOR PATIENTSHOSPITALSVENTURE CAPITALSMALL BIOTECHPATIENTSREGULATORY AGENCYCLINICAL RESEARCH ORGSACADEMIAPharmaceutical innovation takes place in a complex ecosystem with numerous actors from both public and private sectors.Through pro-innovation policies,the EU and national governments support the collective effort to turn science into new medicines.There is along list of actors and stakehold-ers including health authorities,regulators,universities,industry labs,physicians,phar-macists,patients,hospitals,and many more.MANY ACTORS PARTICIPATE IN DRUG DEVELOPMENTPHARMACEUTICAL INNOVATION ECOSYSTEMINVENTING FOR LIFEINVENTING FOR LIFETHE SOURCE OF INNOVATIONMSD POLICY PASSPORT17INVENTING FOR LIFEOver decades,pharmaceutical companies have relentlessly innovated to address unmet medical needs.In 2021,pharmaceutical companies have launched globally a record number of 97 new active substances and vaccines.New active substance refers to any new chemical or biological entity that had received no prior approval.1 DiMasi J.,Gabrowski H.,Hansen R.,Innovation in the pharmaceutical industry:new estimates of R&D costs.J Health Economics,2016.This was a record year,and historical figures show an average rate of 43 new treatments and vaccines launched every year since the start of the millennium.This achievement is quite spectacular,since R&D costs have continued to rise during the last 15 years due to the increasing complex-ity of scientific challenges and increased regulatory requirements.1 Source:Pharmaproject,Pharma R&D Annual Review 2022 Supplement,February 2022.944 INNOVATIVE MEDICINES AND VACCINES LAUNCHED SINCE 2001 Number of new active substances(NAS)and vaccines launched per yearWE DONT REST11362929262826353757434761844926748238313347776131113114221VaccineNAS10203040508070609010002001200220032004200520062007200820092010201120122013201420152016201720182019202020213637THE SOURCE OF INNOVATIONMSD POLICY PASSPORT18INVENTING FOR LIFEDrug development is a long and high-risk endeavour that requires significant capital investment.On average,the development of a new medicine takes 10 to 15 years and costs 2.13 billion.1 To put this into perspective,it took almost 25years between the discovery of the hep-atitis C virus and the development of safe,tolerable,and once-daily treatments that deliver over 95%cure rates.2 1 DiMasi J.,Gabrowski H.,Hansen R.,Innovation in the pharmaceutical industry:new estimates of R&D costs.J Health Economics,2016.2 Burstow et al.,Hepatitis C treatment:where are we now?,Int J Gen Med.,2017.3 Mullard A.,Parsing clinical success rates,Nature Review Drug Discovery,2016.4 PhRMA,Researching Alzheimers Medicines-Setbacks and Stepping Stones,3 June 2021.5 Kannt A.and Wieland T.,Managing risks in drug discovery:reproducibility of published findings,Naunyn Schmiedebergs Arch Pharmacol,2016.A defining feature of drug development is the significant failure rate.Even after years of discovery efforts(preclinical stage),only one out of ten drug candidates that gets tested in clinical trials(phases I to III)achieves marketing approval.3 Failure rates can be as high as 95%in oncology3 or 98%in Alzheimers disease.4Pharmaceutical R&D is indeed a risky business.Most R&D investments dont go into the few molecules that make it to the market,but on the many molecules that fail.5A RISKY BUSINESSWE FOUND THAT APPROXIMATELY ONE IN TEN(10.4%,N=5,820)OF ALL INDICATION DEVELOPMENT PATHS IN PHASE 1 WERE APPROVED BY FDA.Hay et al.,Clinical development success rates for investigational drugs,Nature Biotechnology,2014.R&D PIPELINE BY PHASE IN 20222,0006,00010,0008,00012,0004,000Stage of DevelopmentSource:Citeline Pharma Intelligence,Pharma R&D Annual Review 2022:Navigating the Landscape.THE SOURCE OF INNOVATIONMSD POLICY PASSPORT19INVENTING FOR LIFEExpenditure in million U.S.dollarsMSDS EXPENDITURE ON R&D FROM 2006 TO 2022 5 03,0006,0009,00012,00015,00020064,7834,88320074,805200811,11120108,46720118,16820127,50320137,18 020146,704201510,124201610,20820179,75220189,724201913,397202012,245202113,548202220095,845Did you know?Dr Maurice Hilleman led MSDs Department of Virus and Cell Biology from 1957 to 1984.Throughout his career,he helped develop more than 40 vaccines,including against measles,mumps,hepatitis A and B,chickenpox,meningitis,and pneumonia.“His outstanding scientific endeavours led to vaccines that saved millions of lives,extended human life expectancy,and improved the economies of numerous countries.”Source:Tulchinsky TH.,Maurice Hilleman:Creator of Vaccines That Changed the World.Case Studies in Public Health.2018.Source:MSDs expenditure on research and development from 2006 to 2022,Statista,8 March 2023.Data extracted from MSD Forms 10-K.2010 numbers represent MSD/Schering-Plough merger.THE SOURCE OF INNOVATIONMSD POLICY PASSPORT20INVENTING FOR LIFETHE AVERAGE EFFECTIVE PROTECTION PERIOD HAS DECREASED BY ABOUT TWO YEARS FROM 15 TO 13 YEARS SINCE 1996Copenhagen Economics,Study on the economic impact of supplementary protection certificates,pharmaceutical incentives and rewards in Europe,May2018.THE CRITICAL ROLE OF INCENTIVESIntellectual property rights enable innova-tive companies to raise capital and make the significant R&D investments required to develop new medicines.Fundamentally,when inventing a new treat-ment,pharmaceutical companies discover the properties of a chemical or biological product in humans and demonstrate that it can treat a disease at a particular dose.In that sense,a medicine encapsulates a large amount of scientific and medical knowledge.This“knowledge-in-a-pill”is extremely expensive to develop,but at the same time easy to replicate once it has been discovered:patents are published,and clinical evidence is presented at conferences and in scientific papers.Intellectual property(IP)rights provide some degree of certainty to research-based com-panies that,for a limited period,they can benefit from their R&D investments.Weakening incentives may marginally improve access which in fact depends on many other factors beyond IP rights.1 However,it will primarily disincentivise investments in drug development resulting in less innovation for patients.Nobody can access let alone afford a treatment that has not been invented.DIFFERENT TYPES OF INCENTIVES ARE REQUIRED TO DRIVE INNOVATION FOR DIFFERENT PATIENTS*LOST PATENT LIFESPCs compensate in part patent life lost during clinical development.Adds on average 3.5 years.PRODUCT DEVELOPMENTPRODUCT AVAILABLE FOR PATIENTSSUPPLEMENTARY PROTECTION CERTIFICATEREGULATORY DATA PROTECTION:8 YEARS10-YEAR MARKET EXCLUSIVITY FOR ORPHAN MEDICINESMEDICINEAPPROVED?Patents are filed years before marketing approval and product launch.12-08yearsyears 1 year for a new indication 2 years of market exclusivityyearsTIMELINE2 1 GENERICS STARTENTERING THE MARKETENDOF PATENTPATENT:20 YEARS*Based on EU legislation before reform of general pharmaceutical legislation launched in 2023.1 EFPIA,The root cause of unavailability and delay to innovative medicines:Reducing the time before patients have access to innovative medicines,April 2022.THE SOURCE OF INNOVATIONMSD POLICY PASSPORT21INVENTING FOR LIFENO PATENTS NO MEDICINES,INCLUDING GENERICSIntellectual property is a key driver of medical innovation.Europes incentive framework enables investment into tomorrows treatments.1 PATENTSSUPPLEMENTARY PROTECTION CERTIFICATEREGULATORY DATA PROTECTIONORPHAN DESIGNATIONPAEDIATRIC EXTENSION 20-year exclusivity term Filed years before regulatory approval Publication of the invention 18 months after application Publication ensures that other inventors can benefit from state of the art and push their research further.Average duration of SPCs is 3.5 years(Copenhaguen Economics,2018).Protects investment to generate pre-clinical and clinical data required for regulatory approval.Market exclusivity does not prevent similar products to be authorised if they prove significant benefit.Completion of a Paediatric Investigation Plan is mandatory.From 0 to 5 years Same exclusivity as patent SPC capped at maximum 15 years after regulatory approval 8 years of data exclusivity(generic companies cant rely on clinical data for EMA approval) 2 years of market exclusivity(no generic on the market) 1 year if new indication is developed 10-year market exclusivity linked to one specific orphan designation Incentivise companies to research and develop medicines for rare diseases 6-month SPC extension or 2-year extension of orphan market exclusivity Requires companies to do clinical trials to test safety and efcacy of a medicine for children1 EFPIA,Intellectual Property.Accessed 30 August 20223.THE SOURCE OF INNOVATIONMSD POLICY PASSPORT22INVENTING FOR LIFEFUTURE-PROOFING DRUG APPROVALThe way regulatory authorities approach clinical evidence will either act as a brake or as an accelerator in our ability to bring new treatments to patients.Much of the focus of European policy makers has been on improving access for patients at the point of care.But this can only happen if innovative medicines are approved for marketing.Regulatory approval processes need to be fit for purpose as science and technology evolve.This includes new ways to produce and collect clinical data,or being able to assess drug-device combinations,among others.Despite recent convergence in approval times,the EU still lags behind other leading agencies.In 2020,the median approval time was 244 days in the US,313 days in Japan,and 426 days in the EU.1 Europe should increase the resources of the European Medicines Agency and design a world-class regulatory system that embraces scientific and technological advances in order to accelerate patient access to inno-vative products.THE PACE OF INNOVATION HAS ACCELERATED DRAMATICALLY IN RECENT YEARS AND REGULATORS NEED TO BE READY TO SUPPORT THE DEVELOPMENT OF INCREASINGLY COMPLEX MEDICINES THAT MORE AND MORE DELIVER HEALTHCARE SOLUTIONS BY CONVERGING DIFFERENT TECHNOLOGIES.European Medicines Agency,Regulatory Science to 2025 Strategic reflection,December 2018.POLICY PRIORITIES TO RENEW EUROPES GLOBAL LEADERSHIP IN REGULATORY SCIENCE AND PRACTICES.1 Centre for Innovation in Regulatory Science,New drug approvals in six major authorities 2011-2020:Focus on Facilitated Regulatory Pathways and Worksharing,2021.THE SOURCE OF INNOVATIONMSD POLICY PASSPORT23INVENTING FOR LIFEAGILE REGULATORY PROCESSLearning from our response to the COVID-19 pandemic.COVID-19 pushed regulators to work differently.Faced with a pandemic,they streamlined their review process by intro-ducing rolling reviews thus saving valuable time.This was critical in ensuring the rapid approval and deployment of vaccines and therapeutics against COVID-19.1The regulatory flexibilities introduced during the pandemic have value beyond COVID-19.Driven by digitalisation,innovations in reg-ulatory process(eg,rolling reviews,flexible Scientific Advice)“improved the process and outcomes measurably.”1 Taking stock of the lessons from COVID-19,the head of the European Medicines Agency has called for“a more agile and expertise-based system.”2THE REVISION OF THE EUS PHARMACEUTICAL LEGISLATION OFFERS OPPORTUNITY TO LEVERAGE EXPERIENCE GAINED FROM COVID-19 FOR STREAMLINING REGULATORY PROCESSES.EFPIA,How Regulation Can Boost the EU Innovation?,23 February 2023.DEPLOY DIGITAL SOLUTIONSFLEXIBILITIES ONLANGUAGE&LABELLINGCONDITIONAL MARKETING AUTHORISATIONGENERALISE ROLLING REVIEWS to ensure seamless communication between companies and regulatorsTAILOR ASSESSMENT PROCESS TO EACH PRODUCT CHARACTERISTICS by focusing questions on critical issues and involving appropriate expertsIMPLEMENT ELECTRONIC PRODUCT INFORMATION and common EU packsALIGN VARIATION PROCEDURES WITH INTERNATIONAL STANDARDS such as ICH Q12SHORTEN THE 67 DAYS IT TAKES for the Commission to issue a marketing authorisation 1 Klein et al.,Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU:What Can We Learn from Company Experiences?Ther Innov Regul Sci.,March 2022.2 Emer Cooke,Executive Director of the European Medicines Agency,A future-proof EU regulatory framework key challenges to be addressed,7 February 2023.ROLLING REVIEWSHEALTH COSTSMSD POLICY PASSPORT24INVENTING FOR LIFEVALUE OFINNOVATIONIMF sees cost of COVID pandemic rising beyond$12.5 trillion estimate.Reuters,January 20,2022VALUE OF INNOVATIONMSD POLICY PASSPORT25INVENTING FOR LIFEINNOVATION IS WHAT HELPS THE PATIENT 1 Thomas Allvin,On innovation,patient-centricity and added value,EFPIA,18 Sept.2019.Like science,technology progresses through incremental steps.Patients,doctors,and payers all benefit from these innovations through greater choice and competition across and within therapeutic classes.Everybody likes to talk about“major break-throughs”when it comes to pharmaceutical innovation,and critics are quick to downplay“incremental innovation”,even talking about“me-too”drugs.But patients are different and dont respond similarly to a treatment.Pharmaceutical innovation is about getting better products that help all patients,thus delivering effective patient-centred healthcare.Patients,doctors and payers all benefit from improved treatments,be that in the form of improved drug regimens,less side effects,better tolerability,or ease of use,among others.The patients and their doctors who are helped by these novel treatments wel-come such improvements.1The innovation cycle is driven by competi-tion.Companies race in parallel to develop innovative medicines.They strive to come first to market,but“first”is not necessarily“best”.Not all patients respond the same to a given treatment,and some clinical trials may take longer to complete.Over years of R&D and multiple waves of innovation,new treatments emerge supported by new clinical data and evidence,bringing greater choice for patients and prescribers,and greater competition for payers.IF IHAVE SEEN ALITTLE FURTHER IT IS BY STANDING ON THE SHOULDERS OF GIANTS.Isaac Newton,Letter to Robert Hooke,1676.Adapted from Globerman,S.,Lybecker K.,TheBenefits of Incremental Innovation:Focus on the Pharmaceutical Industry,Fraser Institute,2014.IMPROVED DELIVERY METHODADAPTED TO DIFFERENT PATIENTSDOSING BETTERTOLERABILITY TAILORED TO PATIENTSPRICE COMPETITION FOR PAYERSINNOVATION IS IN THE EYEOF THE BEHOLDERVALUE OF INNOVATIONMSD POLICY PASSPORT26INVENTING FOR LIFEAccording to the WHO,“Vaccines have saved more human lives than any other medical invention in history.”1 More than 20 life-threatening diseases can now be prevented by vaccines.WHO estimates that immunisation prevents 3.5-5 million deaths every year.21234Immunisation campaigns are one of the most cost-effective healthcare interventions.Vaccines protect individuals and the society as a whole,including those who cannot receive it because of age or existing medical conditions.Life-course vaccination also generates billions in savings by preventing the economic impact of lost productivity due to illness.1 WHO,A brief history of vaccines.2 WHO health topics,Vaccines and Immunization.Accessed 14 May 2023.3 Lei J,Ploner A,Elfstrm KM,et al.,HPV Vaccination and the Risk of Invasive Cervical Cancer.N Engl J Med.,2020.4 WHO,Fact sheet on measles,20 March 2023.Accessed 16 May 20235 Faivre et al.,Immunization funding across 28 European countries,Expert Review of Vaccines,2021.6 Vaccines Europe,Realising the full value of vaccination,21 February 2022.Global warming is creating more favourable conditions for mosquito-borne infectious diseases.This will call for surveillance and new preventative methods,including vaccines.VACCINES REMAIN OUR BEST TOOL TO KEEP EU CITIZENS SAFE AND PROTECT OUR NATIONAL HEALTHCARE SYSTEMS AND ECONOMIES.Opening Remarks by Commissioner Stella Kyriakides at the EPSCO Council,9 Dec.2022.PREVENTION IS BETTER THAN CUREVACCINATION IS AN INVESTMENT FOR LIFE HPV vaccination in Sweden led to almost 90%reduction in cervical cancer incidence.3Measles vaccination averted 56 million deaths between 2000 and 2021.4 Two-thirds of EU countries spend less than 0,5%of their health budget on immunisation.5 1 invested in shingles,HPV,and pneumococcal vaccines generates a return of 2.18.5VALUE OF INNOVATIONMSD POLICY PASSPORT27INVENTING FOR LIFEBENDING THE CURVE OF CANCERCancer care is changing fast thanks to strong political commitment at the EU level with Europes Beating Cancer Plan1 and the launch of new treatments across more cancer types.2 As our population is ageing,the number of cancer cases is expected to rise across Europe.3 Cancer incidence increased by around 50tween 1995 and 2018 in Europe.3 However,thanks to advances in screening,diagnostics,and medical treat-ment,the number of people dying of cancer increased much less than the number of people diagnosed with it.3 Despite increased spending on cancer medicines(driven by demographics and the ability to treat more tumour types),the overall cost of cancer care has remained stable over 20 years representing 4-7%of total health expenditure across European countries.3BENDING THE CURVE OF CANCER The impact of prevention,screening,diagnosis and treatmentSource:NORDCAN Association of the Nordic Cancer Registries(04/11/2018)1953020406080100120140160180200220240260280300320340360380195819631968197319781983year198819931998200320082013MaleINCIDENCE:New cancer casesMORTALITY:Cancer DeathsFemaleFemaleMale1 Europes Beating Cancer Plan:A new EU approach to prevention,treatment and care,3 February 2021.2 IQVIA Institute,Global Oncology Trends 2023,May 2023.3 Hofmarcher et al.,Comparator Report on Cancer in Europe 2019 Disease Burden,Costs and Access to Medicines,Swedish Institute for Health Economics.IN EUROPE AS A WHOLE,THE SHARE OF EXPENDITURE SPENT ON CANCER IN 2018 WAS 6.2%,EQUIVALENT TO A PER-CAPITA SPENDING OF 195.Hofmarcher et al.IHE Comparator Report 2019.2THE SOURCE OF INNOVATIONMSD POLICY PASSPORT28INVENTING FOR LIFEOUR FIGHT AGAINST CANCEROncology is now the leading therapy area in terms of R&D efforts.This is measured in number of clinical trials,share of R&D pipe-lines,or number of new cancer treatments being launched.In 2021,a record 35 oncology novel active substances were launched globally,bringing it to a total of 237 since 2003.1 These med-icines included significant clinical advances across a range of tumours.2 1 IQVIA Institute,Global Oncology Trends 2023.2 Hofmarcher et al.,Comparator Report on Cancer in Europe 2019 Disease Burden,Costs and Access to Medicines,Institute for Health Economics,October 2020.3 ESMO,One in Two Patients with Metastatic Melanoma Alive after Five Years with Combination Immunotherapy,28 Sep 2019.The introduction of immunotherapy has led to marked improvements for patients with skin and lung cancer.For example,in only ten years,the 5-year metastatic skin cancer survival rate went from less than one patient in 20 to one patient in two.3 Hofmarcher et al.found that from 2005 to 2015,R&D investment in cancer research by the pharmaceutical industry grew much quicker than investments by public and private non-profit sources,“accounting for around three quarters of total funding.”2NUMBER OF ONCOLOGY NOVEL ACTIVE SUBSTANCESLAUNCHED GLOBALLY AND IN SELECTED COUNTRIESGlobal(237)U.S.(189)EU4 UK(157)Total launched 20032022:Japan(127)China(121)2003-20070204060801001202008-20122013-20172018-2022CHINA-BASED COMPANIES ARE PLAYING AN INCREASING ROLE IN THE ONCOLOGY PIPELINE ACCOUNTING FOR 23%IN 2022,UP FROM ONLY 5%A DECADE AGO.IQVIA Institute,Global Oncology Trends 2023.Source:IQVIA Institute,Global Oncology Trends 2023,April 2023.THE SOURCE OF INNOVATIONMSD POLICY PASSPORT29INVENTING FOR LIFEOrphan medicines address life-threatening or very serious conditions affecting no more than 5 in 10,000 people.Up to 36 million people in the EU live with a rare disease.1 The introduction of new incentives,including a 10-year market exclusivity,through the Orphan Medicinal Products Regulation2 in 2000 led to the development of more than 200 products serving the needs of millions of patients3 with previously unavailable treatment options.5Developing treatments for rare diseases is extremely challenging.There are thousands of rare diseases,most of which affect a very small number of patients about 90%of rare 1 European Commission Expert Group on Public Health,Rare diseases.Accessed 10 May 2023.2 Regulation(EC)No 141/2000 of 16 December 1999 on orphan medicinal products.3 European Commission Staff Working Document-Evaluation of Regulation(EC)No 141/2000,11 August 2020,and orphan medicinal products webpage,accessed 26 September 2023.4 European Medicines Agency,Annual report on the use of the special contribution for orphan medicinal products,March 2022.5 Charles River Associates,An evaluation of the economic and societal impact of the orphan medicine regulation,November 2017.diseases affect about 12%of rare disease patients.The smaller the patient population the more difficult it is to conduct clinical trials.They require more hospital sites in more countries and take longer to enroll a sufficient number of patients to produce meaningful statistical evidence.In addition,scientific knowledge about many of these diseases is limited or even lacking.There is still a high unmet medical need in rare diseases.It is thus critical that we continue to invest in basic science and in-centivise R&D investments in rare diseases by maintaining a robust regulatory and incentives framework.4 THE EU REGULATION ON ORPHAN MEDICINAL PRODUCTS CONTINUES TO BE ASUCCESS IN FULFILLING ITS PRIMARY PURPOSE-TO ATTRACT INVESTMENT TO THE DEVELOPMENT OF THERAPIES FOR LIFE-THREATENING OR DEBILITATING DISEASES FOR MILLIONS OF PEOPLE WHO TODAY HAVE EITHER NO TREATMENT AT ALL OR NO SATISFACTORY TREATMENT.EURORDIS Rare Disease Europe,Breaking the Access Deadlock to Leave No One Behind,January2018.ORPHAN MEDICINES FOR MILLIONS OF PATIENTSSINCE YEAR 200042,552 ORPHAN DESIGNATIONS207 ORPHAN MEDICINESAUTHORISEDVALUE OF INNOVATIONMSD POLICY PASSPORT30INVENTING FOR LIFEPAYER PATIENTMEDICINES HAVE DELIVERED TREMENDOUS PROGRESS IN RECENT DECADES.THEY HAVE IMPROVED SURVIVAL AND QUALITY OF LIFE FOR MANY PATIENTS AND CHANGED THE COURSE OF DISEASES SUCH AS HIV,CERTAIN CANCERS AND MORE RECENTLY,HEPATITIS C.OECD,Pharmaceutical Innovation and Access toMedicines,2018.2VALUE FOR MONEYPharmaceutical innovation delivers outstanding value for money.Many more people are alive today,living longer and have more productive lives thanks to new medicines and vaccines now available across a broad range of diseases.Among many examples,we can cite the 94%reduction in age-standardised death rates from HIV since 1991 in France;the 95%of the 15million Europeans living with HepatitisC who now can be cured;or the 27,000 cer-vical cancer cases and 12,000 deaths that can be prevented each year thanks to HPV vaccination.11 EFPIA,Value of Medicines,2022.2 OECD Health Policy Studies,Pharmaceutical Innovation and Access to Medicines,2018.3 Jenner A.,Pharma innovation giving value for value received,2 April 2014.4 Ostwald et al.,The Global Economic Impact of the Pharmaceutical Industry,WifOR,September 2020.Medicines can also generate savings to health systems.First by reducing or delaying use of more expensive services(eg,hospi-talisation,see page“Money Well Spent”).But also by simply being used as prescribed:the OECD estimates that non-adherence to treatment generates a loss of 125 billion in European countries.2 Beyond their value for patients and health systems,innovative medicines also deliver substantial social and economic benefits to our societies3.The global pharmaceutical industry directly contributed US$532 billion of gross value added to the worlds GDP in 2017 an amount equivalent to the GDP of the Netherlands.4VALUE OF INNOVATIONMSD POLICY PASSPORT31INVENTING FOR LIFEHEALTHY ANIMALS MAKE FOR HEALTHY PEOPLEEnsuring the health of animals is also vitalto safeguarding the health of people.Healthy animals mean a sustainable food supply,protection for humans against diseases passed from animals,and longer,healthier lives for pets.Thats why we are committed to the One Health approach.Disease prevention promotes the health and well-being of both farm and com-panion animals and prevents suffering.Animal vaccines and other treatments such as parasiticides,not only maintain high standards of animal health and well-being,1 https:/ Rahman et al.,Zoonotic Diseases:Etiology,Impact,and Control,Microorganisms,2020.3 Animal Health Europe Manifesto,2019.4 Jonathan Rushton and Will Gilbert,The economics of animal health:Direct and indirect costs of animal disease outbreaks,WOAH 84th general session,May 2016.but they also help to protect consumers from harmful food-borne pathogens or zoonotic agents that can come from farm animals.In addition to prevention and treatments,MSD provides data-driven solutions that empower farmers and veterinarians to safe-guard animals health and secure a healthy food supply.123 4 ANIMAL VACCINATION IS NEEDED TO KEEP ANIMALS HEALTHY.THIS IS AN IMPORTANT PART OF THE ONE HEALTH APPROACH.PREVENTION IS BETTER THAN CURE!Vytenis Andriukaitis,European Commissioner for Public Health,20 April 2018.1Prevents the loss of up to 20%of global animal productioneach year.2 Animal diseases cause major global trade disruptions andgreat economic losses.4More than 60%of human pathogens are fromanimal origin.2 Animal vaccinationprogrammes and the EU petpassport mean that themajority of member statesare now rabies free.3Salmonella infections inhumans decreased by 50%since 2004.3FROM FARM TO FORK ANIMAL HEALTH MATTERS FOR EVERYONEHEALTH COSTSMSD POLICY PASSPORT32INVENTING FOR LIFEHEALTH COSTSThe health and wealth of anation are fundamentally linked.Healthier populations live longer,more productive lives,leading to greater economic prosperity.The Lancet,Editorial,16 March 2019 HEALTH COSTSMSD POLICY PASSPORT33INVENTING FOR LIFEHealthcare costs have been on a rising trajectory for decades.Ageing populations and rising prevalence of non-communicable diseases will continue to contribute to the growing cost burden facing European healthcare systems.1For over 50 years,developed countries have seen healthcare expenditures increase at an average rate of 2 percentage points per year above GDP growth.21 Austerity measures implemented after the 2008 financial crisis led health spending to be in line with GDP.1 Goryakin et al.,Assessing the future medical cost burden for the European health systems under alternative exposure-to-risks scenarios,PLoS ONE,2020.2 World Economic Forum,McKinsey,The Financial Sustainability of Health Systems,2012.3 OECD/EU,Health at a Glance:Europe 2022-State of health in the EU cycle.4 OECD Health Policy Study,Ready for the Next Crisis?Investing in Health System Resilience,2023.5 EFPIA,Value-based healthcare an industry perspective.The COVID-19 pandemic triggered a sharp rise in health spending,and exposed major weaknesses in our health systems.32 There is now a consensus that key investments are needed to strengthen health systems resilience.43The adoption of value-based healthcare can help meet the goals of effective and affordable care by addressing inefficiencies and quality issues.54 FOR POLICY MAKERS STRUGGLING TO COPE WITH EVER-GROWING HEALTH CARE EXPENDITURE,THE OPPORTUNITY TO MOVE TOWARDS VALUE-BASED HEALTH CARE MUST BE PURSUED DECISIVELY.WHY DO HEALTH COSTS INCREASE?ANNUAL GROWTH IN HEALTH SPENDING AND GDP,OECD AVERAGESource:OECD,Ready for the Next Crisis?Investing in Health System Resilience,2023.4OECD(2017),Tackling Wasteful Spending onHealth.HEALTH COSTSMSD POLICY PASSPORT34INVENTING FOR LIFEIllness doesnt only affect peoples health,but also their ability to contribute to society.Better health promotes economic growth by expanding the labor force and by boosting productivity,while also delivering immense social benefits.1At the population level,lower productivity due to illness represents an economic loss to society.In 2020,illnesses and health problems cost 431.8 billion in Germany a 28%increase from 2015 figures.2According to the OECD,when the COVID-19 pandemic struck,European health systems were unprepared due to underinvestment.3The lesson from the pandemic is that health-care is a strategic investment.Fiscal policy should integrate the value of preventing and treating disease as critical for achieving macro-economic objectives.4DISEASE IS THE REAL COST,NOT THE TREATMENTTHE IMF SEES THE COST OF COVID PANDEMIC RISING BEYOND ITS$12.5 TRILLION ESTIMATE.Reuters,January 20,2022.Vaccinating all eligible women in EU27 against HPV would increase work productivity and labour income by 5.7M working hours and 387.0M respectively.5Boosting investment in the care of 11 leading cancers would provide a 3.7-fold return on investment by 2030 thanks to productivity gains.6HEALTHCARE IS AN INVESTMENTNew curative treatments against hepatitis C improved patients work productivity by 16-20%.71 McKinsey Global Institute,Prioritizing health-A prescription for prosperity,July 2020.2 Statistisches Bundesamt(Destatis).27 July 2022.3 OECD Health Policy Study,Ready for the Next Crisis?Investing in Health System Resilience,2023.4 Rheinberger C.,Herrera-Araujo D.,Hammitt J.,The value of disease prevention vs treatment,Journal of Health Economics,2016.5 EFPIA and Vintura,Demonstrating the power of innovation in Europe,page 19,October 2022.6 EFPIA,Power up health systems,2022.7 Younossi Z.et al,Impact of eradicating hepatitis C virus on the work productivity of chronic hepatitis C patients:an economic model from five European countries.J Viral Hepatitis,2016.HEALTH COSTSMSD POLICY PASSPORT35INVENTING FOR LIFEFor over a decade prior to the COVID-19 pandemic,governments have been targeting drug expenditures as their main opportunity to achieve savings.As a response to the 2008-2010 financial and fiscal crisis,European governments implemented cost-containment measures in their healthcare systems.Pharmaceutical 1 See OECD/EU,Health at a Glance 2021:OECD Indicators,and Health at a Glance:Europe 2022.2 OECD/EU,Health at a Glance:Europe 2018:State of Health in the EU Cycle.3 IQVIA Institute,Understanding Net Pharmaceutical Expenditure Dynamics in Europe,April 2022.spending was one of their primary targets through price cuts,compulsory rebates,delisting of pharmaceuticals,industry-level clawbacks,etc.As a result,since the early 2010s,pharmaceutical spending is no longer the primary driver of increased healthcare cost growth.1,3AFTER THE FINANCIAL CRISIS,EU RETAIL PHARMACEUTICAL EXPENDITURE FELL BY ANANNUAL AVERAGE RATE OF 0.7TWEEN 2008 AND 2012.SPENDING THEN RECOVERED BETWEEN 2012 AND 2016,RISING BY ANAVERAGE OF 0.8%PER YEAR.OECD/EU,Health at a Glance:Europe 2018.2Source:OECD Health at a Glance 2021,figure 7.16,page 199.HEAVY FOCUS ON DRUG BUDGETS4320.3-0.9-0.2-0.12.13.13.11.32.52.210-1-2Inpatient careAnnual growth in real terms(%)2009-20132013-20193.41.3Outpatient careLong-term carePharmaceuticalsPreventionAdministrationANNUAL GROWTH IN HEALTH EXPENDITURES FOR SELECTED SERVICES OECD average,200913 and 2013-19(real terms)HEALTH COSTSMSD POLICY PASSPORT36INVENTING FOR LIFEIMPACT OF USE OF NEW CARDIOVASCULAR TREATMENTS ON HOSPITALISATION COST (1995-2004)ALTHOUGH NEW DRUGS CAN APPEAR EXPENSIVE WHEN CONSIDERED IN ISOLATION,PHARMACEUTICAL INNOVATION LEADS TO COST SAVINGS ELSEWHERE IN THE SYSTEM THROUGH THE REDUCED USE OF HEALTH SERVICES LIKE HOSPITALS AND NURSING HOMES.Prof.Frank R.Lichtenberg,Columbia University Graduate School of Business.Source:Frank R.Lichtenberg,Have newer cardiovascular drugs reduced hospitalization?Evidence from longitudinal country level data on 20 OECD countries,1995-2003.Health Economics,2009.MONEY WELL SPENTAcross developed countries,drug spending is a small proportion of healthcare spending,representing 15%on average(ranging from 920%).1 This share“has remained stable to declining across almost all markets.”1 It is clear that simply decreasing drug spend-ing a minor part of health budget will not solve the issue of healthcare cost increase.In fact,targeting cost-effective pharmaceutical interventions may lead to unintended con-sequences both in terms of health outcomes and long-term budget impact.1 IQVIA Institute,Drug Expenditure Dynamics 19952020:Understanding medicine spending in context,October 2021.2 IPHA,New Medicines for Patients as Fast as in Europe:Need for Sustained Funding Growth,2018.Rapid introduction and appropriate use of innovative medicines can help reduce the total cost of care,when it prevents or delays more expensive interventions such as hospitalisation.When access to innovative medicines is slowed,healthcare systems lose out on potentially greater savings,but more importantly on better health outcomes.2 1 Spending$24 per capita on new medicines generates savings of$89per capita in hospital costs.HEALTH COSTSMSD POLICY PASSPORT37INVENTING FOR LIFEPHARMACEUTICAL EXPENDITURESIQVIA Institute,Understanding Net Pharmaceutical Expenditure Dynamics in Europe,April 2022.The proportion of pharmaceutical expenditure in healthcare expenditure has remained either flat or reduced in most countries since 2000.PHARMACEUTICAL EXPENDITURESMSD POLICY PASSPORT38INVENTING FOR LIFE41,24714.6%EU GDP per capitaEU health spending per capitaEU pharmaManufa-cturer priceMandatoryrebatesNet manufacturer PriceCommercial rebatesRetro-activeclawbacksNetmanufa-cturer price3,159462According to the OECD,“spending on retail pharmaceuticals(including other medical non-durables)averaged 462 per person across the EU in 2020.”1This figure represents less than 15%of the 3,159 per capita Europeans spent on healthcare the same year.However,this figure also includes over-the-counter products,as well as non-durable medical goods such as first aid kits or face masks.The OECD estimates that“around three out of every four euros spent on retail pharmaceu-ticals(including other medical non-durables)goes on prescription medicines.”11 OECD/EU,Health at a Glance:Europe 2022-State of health in the EU cycle.2 IQVIA Institute,Understanding Net Pharmaceutical Expenditure Dynamics in Europe,April 2022.Due to national differences in data collection and reporting,OECD spending data do not include pharmaceuticals used in hospitals,but OECD estimates it“can typically add another 20%to a countrys pharmaceutical bill.”1 This level of uncertainty greatly varies across European countries.According to the IQVIA Institute,in a third of European countries,public data on pharmaceutical spending is either non-existent,unavailable,or incomplete.23 PUTTING PHARMACEUTICAL EXPENDITURES IN PERSPECTIVEINFORMATION ON PHARMACEUTICAL EXPENDITURE SHOULD BE MADE TRANSPARENT TO SUPPORT DECISION-MAKING.IQVIA Institute,April 2022.2HOW MUCH DO WE SPEND ON DRUGS?Source:EUROSTAT,OECD/EU,Health at a Glance:Europe 2022.1Source:IQVIA Institute,April 2022.2PHARMACEUTICAL EXPENDITURESMSD POLICY PASSPORT39INVENTING FOR LIFEDuring the last decade,pharmaceutical spending has not been the driver of in-creased healthcare costs.The topic of growth in pharmaceutical expenditure is regularly cited as the larg-est area of concern for European payers.However,while pharmaceutical spending was attracting most public debate,pharmaceuti-cal expenditure represented only 11%of the absolute growth in healthcare expenditure during the five years prior to the pandemic(20142018).As this is lower than the 15%it represents in health budgets,“it means that the share of pharmaceutical expenditure has been shrinking over this period.”1 1 IQVIA Institute,Understanding Net Pharmaceutical Expenditure Dynamics in Europe,April 2022.2 Espin et al.,Projecting Pharmaceutical Expenditure in EUS to 2021:Adjusting for the Impact of Discounts and Rebates.Applied Health Economics and Health Policy,2018.The IQVIA Institute found that,“the share of pharmaceutical spending has been shrinking”in recent years.This results from pharmaceutical spending growth being in-ferior to growth rate of non-pharmaceutical interventions.123PHARMA GROWTH RATE FALLING SINCE 2000-BELOW SHARE OF TOTAL HEALTHSource:IQVIA Institute,Understanding Net Pharmaceutical Expenditure Dynamics in Europe,April 2022.SHARE OF DRUG SPENDINGPHARMACEUTICAL EXPENDITURE IS UNDER CONTROL,BELOW PREDICTED HEALTHCARE EXPENDITURE GROWTH IN EUROPE,AND IN LINE WITH LONG-TERM ECONOMIC GROWTH RATES.Espin et al.,2018.2Total healthcare growthPharmaceuticals growth0246810121489solute growth 2014 2018PHARMACEUTICAL EXPENDITURESMSD POLICY PASSPORT40INVENTING FOR LIFEDRUG SPENDING AS SHARE OF TOTAL HEALTHCARE IN SELECTED COUNTRIES Drug spending(retail and hospital)as%of healthcare spending in real PPP 2020$,2000-2018DRUG SPENDING IS STABLE AS A SHARE OF HEALTH BUDGETSSince 2000,pharmaceutical expenditure across a range of European countries has declined in the majority or remained stable for over 20 years.For countries that provide a complete dataset to the OECD(inclusive of hospital expenditure)or via a transparent public approach,drug spending averages 12%of their total healthcare spending(ie,Spain,Belgium,Italy,Czechia,Denmark,Sweden,and Norway).While the last 20 years have seen dramatic changes in pharmaceutical innovation and the number of patients treated,the share of pharmaceutical spend-ing relative to healthcare expenditure has reduced or remained flat in most countries since 2000.11 IQVIA Institute,Understanding Net Pharmaceutical Expenditure Dynamics in Europe,April 2022.2 BPI,Pharma-Daten 2022.Public debates generally focus on unit prices of medicines,but generally ignore(i)the actual budget impact which depends on the number of patients,and(ii)what payers actually pay after discounts,mandatory rebates,clawbacks,budget caps,and other cost-containment measures.Moreover,what is reported as net phar-maceutical expenditure represents more than pharmaceutical companies sales,as it includes distribution costs,dispensing fees,and taxes.VAT rates in particular range from 25%in Denmark,19%in Germany,2.1%in France,to 0%in Sweden.2THE SHARE OF DRUG SPENDING HAS REMAINED STABLE TO DECLINING ACROSS ALMOST ALL MARKETS IN RECENT YEARS.IQVIA Institute,Drug Expenditure Dynamics 19952020,October 2021.51015202530UKNODKSEBESIIEAVERAGEITFRESBGCZDESource:IQVIA Institute,April 2022.1PHARMACEUTICAL EXPENDITURESMSD POLICY PASSPORT41INVENTING FOR LIFETHE PUBLIC PRICE IS NOT WHAT THE PUBLIC PAYSWhen we read about the price of a medicine in the papers(including in academic arti-cles),it refers to the publicly available price,or“list price”,which is almost never the price charged to health systems.The real,“net price”is lower and kept confidential,as it reflects rebates and other discounts negotiated by the payer.The net price is also difficult to calculate,as it can be further lowered through indus-try-level clawbacks or budget caps that apply retroactively and indiscriminately across all pharmaceutical spending.12 As sole purchasers and regulators,national payers benefit from significant power to set the price and reimbursement level of medicines be it through mandatory rebates or negotiation.1 IQVIA Institute,Understanding Net Pharmaceutical Expenditure Dynamics in Europe,April 2022.2 Eliana Barrenho and Ruth Lopert,Exploring the consequences of greater price transparency on the dynamics of pharmaceutical markets,OECD Health Working Health Working Paper No.146,September 2022.This position of power is illustrated by the numerous cost-containment measures that all European countries have deployed over the last decade to keep their pharmaceutical expenditure in check.SIMPLIFIED VERSION OF A PRICE NEGOTIATIONPAYERS MAY NEGOTIATE WITH INDUSTRY UNDISCLOSED UP-FRONT DISCOUNTS,PRICE-VOLUME ARRANGEMENTS OR EXPENDITURE CAPS WITH EX-POST REBATES,ALL OF WHICH CAN REDUCE NET PRICES TO WELL BELOW THE LIST PRICES PROPOSED BY MANUFACTURERS.OECD Health Working Health Working Paper No.146,September 2022.2Company proposes apriceFirst round of negotiation leads to the list priceNet price aftermandatory and confidential rebatesProposed priceList price(public)Net price(confidential)Retroactive clawbacks and budget caps will further decrease the net price.1PHARMACEUTICAL EXPENDITURESMSD POLICY PASSPORT42INVENTING FOR LIFEINTERNATIONAL PRICE COMPARISONCan we sustain affordability of drugs across Europe if countries with very different GDP per capita,different level of healthcare spending,different epidemiology,and different public health priorities want the same price?Comparing pharmaceutical prices with other countries called“external reference pric-ing”is widely used across Europe.Hoping to benefit from the price negotiated by other countries provided it is lower,payers include a basket of other countries price in their own pricing negotiations.The most detrimental effect of external reference pricing is that it forces price con-vergence across countries that do not have the same level of GDP,healthcare spending,or health priorities.By preventing companies from applying dif-ferential pricing,external reference pricing may delay access to innovative drugs for patients in lower income countries,as the narrower price band is above these coun-tries affordability threshold.1Pharmaceutical prices should be based on avariety of criteria,including the value of the product,patient benefits,the disease burden,government health priorities and physician requirements.SAVINGS FOR THE RICH,DELAYED ACCESS FOR THE POORPRICING TO MARKET IS INCREASINGLY NOT POSSIBLE IN AN ERA OF FREE TRADE AND EXTERNAL PRICE REFERENCING.THIS MAY WELL RESULT IN PROBLEMS IN THE AVAILABILITY AND AFFORDABILITY OF SOME MEDICINES IN SOME COUNTRIES.OECD,Pharmaceutical Pricing Policies in a Global Market.21 Kal et al.,Differential pricing of new pharmaceuticals in lower income European countries,Expert Review of Pharmacoeconomics&Outcomes Research,2013.2 OECD Health Policy Studies,Pharmaceutical Pricing Policies in a Global Market,September 2008.PHARMACEUTICAL EXPENDITURESMSD POLICY PASSPORT43INVENTING FOR LIFETHE UNINTENDED CONSEQUENCES OF PRICE TRANSPARENCYShould wealthy countries benefit from the price paid by poorer countries?Will com-panies compete more once they know the price negotiated by their competitors?Is public interest better served by disclosing confidential prices,or by ensuring greater rebates?These are some of the questions that need to be asked when considering the calls for greater transparency of pharma-ceutical prices.The official price of a pharmaceutical is public.However,this public price rarely represents the price paid,as it typically doesnt reflect the rebates,discounts,clawbacks,and other terms negotiated with payers.The price after negotiation(“net price”)is generally kept confidential to ensure companies can apply differential pricing,i.e.,adjust their price according to the ability to pay of different countries.1 1 Danzon P.M.,Towse A.,Differential Pricing for Pharmaceuticals:Reconciling Access,R&D and Patents.International Journal of Health Care Finance and Economics 3,183205(2003).2 For example,the Irish Information Commissioner(case 170395,13 April 2018),and the Italian Consiglio di Stato(sezione III sentenza n.1213 filed on 17 March 2017)recognized the existence of a higher general interest in maintaining price confidentiality.3 Bentata P.,Riccaboni M.,Van Dyck W.et al.The consequences of greater net price transparency for innovative medicines in Europe:Searching for a consensus.Charles River Associates.2020.4 Kal et al.,Differential pricing of new pharmaceuticals in lower income European countries,Expert Review of Pharmacoeconomics&Outcomes Research,2013.Authorities have often recognised the value of confidentiality as it facilitates greater rebates from companies.2 Economic models have also shown that the disclosure of net prices results in price convergence-forcing companies into a narrower price band,which prices out lower-income countries.3,4LOWER-INCOME MARKETS COULD EXPECT PRICE INCREASES UNDER TRANSPARENT CONDITIONS,WHEREAS HIGHER-INCOME AND LOW-VOLUME MARKETS COULD EXPECT PRICE DECREASES.The consequences of greater net price transparency for innovative medicines in Europe,Charles River Associates.3NET PRICE TRANSPARENCY WOULD AMPLIFY ACCESS DELAYS ALREADY AFFECTING PATIENTS IN LOWER-INCOME MARKETS2Source:Kalo et al.,2013.3 PHARMACEUTICAL EXPENDITURESMSD POLICY PASSPORT44INVENTING FOR LIFEREWARD VALUE TO THE PATIENTREWARD INNOVATIONALLOW RAPID ACCESSBE PREDICTABLE AND TRANSPARENTIN EUROPE,PRICING DECISIONS REMAIN UNPREDICTABLE,RESULTING IN ANUNPREDICTABLE LOTTERY FOR COMPANIES WHO HAVE BROUGHT APRODUCT THROUGH ASERIES OF REGULATORY HURDLES AND STILL DO NOT KNOW WHAT THE FINAL REIMBURSEMENT PRICE WILL BE.WHO Report,Priority Medicines for Europe and the World,2004.Pricing and reimbursement systems should be based on patients health outcomes,promote rapid access,reward innovation,and be predictable and transparent.After marketing approval,pricing and re-imbursement is a crucial step in ensuring that patients have access to innovative medicines.OUTCOMEAt MSD we are engaged with payers to en-sure we reach our common goals of rapid patient access,improved health outcomes,and sustainable budgets.We strive to achieve mutually beneficial agreements with payers to ensure that our medicines and vaccines are accessible and affordable,while ensuring that we can con-tinue to invest in the next generation of MSD inventions.PHARMACEUTICAL EXPENDITURESMSD POLICY PASSPORT45INVENTING FOR LIFEHealth Technology Assessment(HTA)is amultidisciplinary process that summarises information about the medical,social,economic and ethical issues related to the use of ahealth technology in asystematic,transparent,unbiased,and robust manner.HTAs are currently conducted at the national level,but the EU is finalizing the implementation of a new Regulation on HTA that will harmonize clinical effectiveness assessments to inform national pricing and reimbursement decisions.It is crucial that both private and public bodies that produce or review the evidence follow agreed upon,scientifically validated and transparent methodologies.HTA can be animportant process through which the value of amedicine or vaccine can be inves-tigated in the context of aset populations needs.Harmonisation of HTA requirements is crit-ical for patients to avoid duplicative work,such as unnecessary trials,potential delays,and access restrictions that are not based on the intrinsic properties of a medicine,but administrative requirements.TRANSPARENCY,SCIENTIFIC RIGOUR AND AN UNBIASED APPROACH TO EVIDENCE GENERATION ARE ESSENTIAL FEATURES OF HTAHEALTH TECHNOLOGY ASSESSMENTConsistency ofthe assessment requirementsIncreased scientific quality ofassessmentPredictability ofevidence synthesis,timelines and interpretationsSpeed of decision-making process at national levelBENEFITS OFCOOPERATION ONHTAPHARMACEUTICAL EXPENDITURESMSD POLICY PASSPORT46INVENTING FOR LIFEVALUE-BASED PRICING IS PATIENT-CENTRICPayers want value.and then negotiate.The goal of pharmaceutical pricing is to ensure that innovative medicines are af-fordable to healthcare systems,whilst also rewarding innovation that delivers value to society.1 The WHO defines value-based pricing as a method to set pharmaceutical prices“according to the measurable benefits that patients and health systems find in them”.2 Value-based pricing allows health authori-ties to base their procurement decisions on criteria that matter to patients,healthcare systems,and society thus delivering a triple win.3 Examples of value include improved health outcomes and quality of life for patients,cost offsets and savings for health systems,and a healthier and more productive popu-lation for society.By measuring health outcomes against the cost of delivering those outcomes,value-based pricing allows healthcare sys-tems to promote patient-centred care and efficiency.Alternative pricing methods such as cost-plus approaches based on R&D and production costs are inefficient(no incentive to cut costs)and do not reflect the value of a medicine to society.It fails to signal to phar-maceutical companies where to focus their R&D investments,ie,what health authorities are willing to pay for.Value-based pricing enables greater af-fordability,provided that pharmaceutical spending is integrated with other types of spending.For example,an innovative dia-betes treatment that helps patients better manage their glucose level,thus improving their life and preventing visits to the emer-gency room,is value for money.However,such value can only be extracted if pharma-ceutical budgets are not siloed from hospital budgets,so that cost offsets generated in other parts of the health system are taken into account.41 EFPIA,A value-based approach to pricing,April 2023.2 Value-based pricing:WHO guideline on country pharmaceutical pricing policies:a plain language summary.3 Office of Health Economics,Delivering the Triple Win:A Value-Based Approach to Pricing,April 2023.4 Vintura,Broadening the Perspective:Recommendations for improving pharmaceutical affordability,2023.MSD POLICY PASSPORT47A KNOWLEDGE-BASED ECONOMYINVENTING FOR LIFESPECIAL CHALLENGESI have not failed.Ive just found 10,000 ways that wont work.Thomas EdisonSPECIAL CHALLENGESMSD POLICY PASSPORT48INVENTING FOR LIFEThe World Health Organisation considers antimicrobial resistance one of the greatest public health threats facing humanity.1 Antibiotics have revolutionised infectious disease treatment,saving millions of lives worldwide.However,rising levels of resistance to antibiotics are reducing the ef-fectiveness of these treatments and putting these health gains at risk.If left unchecked,resistance to last resort drugs against diffi-cult-to-treat infections could be about 3.4 times higher by 2035 in the EU/EEA region compared to 2005.21 WHO,Fact sheet on antimicrobial resistance,17 november 2021.2 OECD,Embracing a One Health Framework to Fight Antimicrobial Resistance,2023.3 ECDC,35,000 annual deaths from antimicrobial resistance in the EU/EEA,press release 17 November 2022.4 Butler et al.,Analysis of the Clinical Pipeline of Treatments for Drug-Resistant Bacterial Infections:Despite Progress,More Action Is Needed,Antimicrobial Agents and Chemotherapy,2022.According to the ECDC,at least 35,000 people die annually from antimicrobial resistance in Europe alone.3 Unless action is taken,we could revert to aworld where simple infec-tions are no longer treatable.Antimicrobial resistance carries a heavy health and economic burden,including longer hospital stays,higher medical costs,and increased mortality.New antibiotics are urgently needed to address the growing threat of resistance.4 THE GLOBAL HEALTH THREAT OF ANTIMICROBIAL RESISTANCEANTIMICROBIAL RESISTANCE INDEX EU/EEASource:OECD,Embracing a One Health Framework to Fight AMR,figure 2.8.2Third-line(last resort)Second-line(reserve)First-line350300250200150100502005203520302025202020152010SPECIAL CHALLENGESMSD POLICY PASSPORT49INVENTING FOR LIFETHERE IS A WORRYING TREND OF DELAYED AVAILABILITY FOR NEW ANTIBIOTICS IN EUROPE.THE REASON IS THAT THE EUROPEAN MARKET IS LESS ATTRACTIVE BECAUSE OF LOW SALES AND LOW PRICES.Christine rdal,Norwegian Institute of Public Health,Antimicrobial resistance and COVID-19-How can Europe incentivise R&D to protect our future?,European Health Forum Gastein,1 October 2020.ANTIMICROBIAL RESISTANCE CHALLENGES AND SOLUTIONSPUSH INCENTIVESREGULATORYCHALLENGES Incentives such as grants and refundable tax credits can stimulate pre-clinical and clinical R&D.Reduce the risk of earlyinvestment in antibiotic R&DNew incentives,like transferable exclusivity vouchers,would decouple economic returns from sales volume,thus guaranteeing appropriate rewards for essential innovations.Novel antibiotics are used sparingly to preserve efectiveness.Most reimbursement models undervalue novel antibiotics and disincentivize their use(esp.,bundled payment and DRGs).6Allow providers to use novel antibiotics appropriately and ensure that value assessment of novel antimcrobials includes cost and societal impact of AMR.ECONOMICCHALLENGES SCIENTIFICCHALLENGES DELINKED MECHANISMSPAYMENT&HTA REFORM!Reward innovation earlier in the products life cycle!Complex clinical trials.Complex regulatory pathways.Constantly evolving bacteria.Resistance difcult to predict.MSD has a long history of discovering and developing anti-infectives for both humans and animals.While many companies have pulled away,MSD is still active in the fight against antimicrobial resistance supporting solutions that promote prudent use and reduce the need for antibiotics.55 MSD is supporting the Global AMR Action Plan,the AMR Industry Alliance,and the AMR Action Fund among other activities in the fight against antimicrobial resistance.Accessed 21 March 2024.6 Bundled payments and Diagnosis-Related Groups prioritise cost containwment.As a result,hospitals and providers are incentivised to use cheaper,older antibiotics to stay within budget,even when a novel antibiotic might be clinically superior(US Office of the Assistant Secretary for Planning and Evaluation,Understanding Markets for Antimicrobial Drugs,Issue Brief,August 2023,ASPE website).SPECIAL CHALLENGESMSD POLICY PASSPORT50INVENTING FOR LIFEA NEW INCENTIVE TO FIGHT MICROBESNew incentives are needed to revitalise re-search and development of new antibiotics.Drug resistance is a fact of life.This is why,in addition to prudent use of existing treatments,we need a constant stream of new antimicrobials to replace those lost to bacterial resistance.111 WHO,Lack of new antibiotics threatens global efforts to contain drug-resistant infections,17 january 2020.2 Christine rdal,Norwegian Institute of Public Health,Antimicrobial resistance and COVID-19-How can Europe incentivise R&D to protect our future?,European Health Forum Gastein,1 October 2020.3 Charles River Associates,A framework for assessing the potential net benefits realized through Transferable Exclusivity Extension(TEE)as an incentive for development of novel antimicrobials,2022.Unfortunately,due to low price and low volume,antimicrobial R&D has been drying up.23To unlock R&D investment and replenish our pipeline at the required scale,we need a new type of incentive.Transferable exclusivity vouchers have been fully evaluated and are one of the most promising solutions to achieve this objective.3MARKET FAILURE OR POLICY FAILURE?TRANSFERABLE EXCLUSIVITY VOUCHERSPricing and reimburse-ment systems do not recognize the added value of new antimicrobials.LOW PRICENew antimicrobials must be used sparingly to preserve their effectiveness and slow the development of resistance.LOW VOLUMEStandard reward model doesnt work.Extending exclusivity(SPC )wont address low volume and low price.LOW INCENTIVEHOW DOES IT WORK?A company getting an eligible priority antimicrobial approved would receive the right to extend the exclusivity period of another product in its portfolio or sell this right to another company.WHY DOES IT WORK?Reward at marketing-approval stage Works for companies ofall sizes Supports prudent use asreward is delinked from salesVALUE TO SOCIETYAMR could lead to an annual decrease in European GDP of$180bn$680bn by 2050.2An economic review shows that the benefits and cost-savings generated by exclusivity vouchers far exceed their costs.2SPECIAL CHALLENGESMSD POLICY PASSPORT51INVENTING FOR LIFEGiven the impact on patient care,it is essential that shortages are addressed as a public health issue.The revision of the EUs general pharmaceutical legislation should span all value chain segments to close the gaps while supporting innovative and sustainable manu-facturing and supply.DATA GATHERING AND TRANSPARENCY To improve demand forecasting through EU-level platforms USE EMVS DATA To collect information on supply and demand,and inform the European Shortages MonitoringPlatform maintained by EMA PREVENT NATIONAL STOCKPILING To ensure supply can meet demand where its needed most ALLLOW ELECTRONIC PRODUCT INFORMATION To ensure manufacturing and supply flexibility BUILD FLEXIBLE&RESILIENT SUPPLY CHAINS Adopt regulatory solutions that facilitate rapid reallocation across countriesADDRESSING MEDICINE SHORTAGESMEDICINE AND VACCINE SHORTAGES ARE CAUSED BY MULTIPLE FACTORSNATIONAL STOCKPILING REQUIREMENTSPRODUCTIONCHALLENGESEXPORTBANSSUDDEN SURGEIN DEMANDSUPPLY CHAINDELAYSREGULATORY CONSTRAINTS REDUCING FLEXIBILITYSOLUTIONSSPECIAL CHALLENGESMSD POLICY PASSPORT52INVENTING FOR LIFEFASTER PATIENT ACCESS1 EFPIA,Patients W.A.I.T.Indicator Survey 2022.2 CRA/EFPIA,The root cause of unavailability and delay to innovative medicines,April 2023.3 Charles River Associates,European Access Hurdles Portal:initial results,April 2023.Depending on where they live,European patients will not access new medicines at the same time.Despite a centralized approval of medicines,a patient in Romania will wait seven times longer than a patient in Germany to have access to a new treatmentfor the same disease.1Even in the EU,health systems remain a national competency.Due to legal,organi-sational,and cultural differences,healthcare funding,delivery,and access greatly vary between countries.A medicine approved at the EU level will still be faced with at least 27 different pathways(not counting regions)before it can be available for patients in each member state.An analysis of the root causes of access delays identified three major choke points:regulatory processes the time it takes for a medicine to be approved;filing for pricing and reimbursement(P&R)the time it takes companies to constitute and file their P&R dossier;and pricing and reimbursement processes time it takes authorities to reach the funding decision.2Early results from the European Access Hurdles Portal3 show that about a quarter of the delays for a new medicine to be available in a given country are due to companies de-cision-making to file for P&R,while the rest of the delays(75%)is due to national P&R process and funding decision-making.THERE IS NO SINGLE ACTOR OR LEGISLATION THAT CAN ADDRESS THIS ISSUE IN ISOLATION.IF THERE WAS A SILVER BULLET,WE WOULD HAVE FOUND IT BY NOW.Nathalie Moll,Director General,Faster,more equitable access to medicines across Europe,webinar,3 May 2023.RELATIVE DURATION OF KEY STEPS BEFORE AVAILABILITY OF A MEDICINEMARKETINGAPPROVALFILING FORP&RP&RDECISION25u%Time forregulatoryreviewTime for company to file for pricing and reimbursementTime for authorities to reach pricing and reimbursement decisionSource:EFPIA,European Access Hurdles Portal:initial results,April 2023.SPECIAL CHALLENGESMSD POLICY PASSPORT53INVENTING FOR LIFERate of availability,measured by the number of medicines available to patients in Europeancountries as of 5th January 2023.For most countries this is the point at which the product gainsaccess to the reimbursement list.The time from central approval to availability is the days between marketing authorisation andthe date of availability to patients in European countries(for most this is the point at whichproducts gain access to the reimbursement list).Source:EFPIA,Patient WAIT Indicator 2022 survey.NUMBER AND RATE OF MEDICINES AVAILABILITY(2018-2021)IQVIA,EFPIA Patient WAIT Indicator 2022 surveyTIME FROM CENTRAL APPROVAL TO AVAILABILITY(2018-2021)IQVIA,EFPIA Patient WAIT Indicator 2022 survey02004006008001000128191301320328399432436472499507 508518546 549553561567578590629674702 7058279180204060801001201401601801681471351321271121031009998959090857674726559575651494632312621SPECIAL CHALLENGESMSD POLICY PASSPORT54INVENTING FOR LIFEUnder EU law,medicinal products must be dispensed with a paper leaflet providing information about the product to help pa-tients understand their treatment and how to use safely.Product leaflets provide important infor-mation,but the requirement to use a paper version does not provide the same level of flexibility available with electronic product information.For example,an electronic ver-sion can provide the most recent approved information without any delay,thus increas-ing patient safety.Electronic product information also facil-itates multi-language information to be made available as more people move across Europe or come from non-EU countries.Electronic product information can also reduce the volume of paper and ink used in the production process,thus improving pharmaceutical products environmental footprint.1 ELECTRONIC PRODUCT INFORMATIONSUSTAINABLEReduces paper waste and the environmental footprint of pharmaceu-tical productionELECTRONIC PRODUCT INFORMATION IS BETTER FOR PATIENTS ANDBETTER FOR THE PLANET!BENEFITS OF ELECTRONIC PRODUCT INFORMATIONUSER FRIENDLYChoice of multiple languages,including from outside the EUSUPPLYMitigates risk of shortages by optimising supply(no need for re-labelling)READABLEPersonalised reading experience(enlarge)and improved accessibility for patients with diverse abilities.RELIABLENo delays for patients in accessing up to date product information1 Nauvelaerts K.and Tellner P.,Electronic Product Information Making the latest medicines information available for patients without any delay,EFPIA blog,2 November 2022.MSD POLICY PASSPORT55A KNOWLEDGE-BASED ECONOMYINVENTING FOR LIFEBEYOND INNOVATIONFrom finding solutions for some of the worlds most debilitating diseases,to getting our medicines and vaccines to those in need and building more effective health systems,we are always on a mission to create a better world.Environmental,Social and Governance at MSDBEYOND INNOVATIONMSD POLICY PASSPORT56INVENTING FOR LIFEEvery two minutes,a woman dies from complications related to pregnancy and childbirth globally.Most of these deaths are preventable when women have access to modern contraception and quality ma-ternal health care before,during,and after childbirth.Launched in 2011,MSD for Mothers is our companys$650 million global initiative to help create a world where no woman has to die while giving life.Today,MSD is working with more than 165 partners in more than 65 global sites to improve maternal health.1Our efforts target three areas:Supporting quality accreditation of local health providers.Developing and deploying private sector innovations(eg,addressing postpartum hemorrhage2).Incorporating local and community-led solutions.IN THE SUCCESSFUL COOPERATION WITH MSD FOR MOTHERS,MATERNAL MORTALITY IS PUT IN FOCUS.ACCESS TO MATERNAL HEALTHCARE IS AFUNDAMENTAL HUMAN RIGHT.Silvana Koch-Mehrin,Founder and President of Women Political Leaders Global Forum.MSD FOR MOTHERSLearn more about MSD for Motherswomen reached with programs promoting safe,high-quality,respectful care21Mproviders trained to offer quality care578Kpeople reached through improved access to quality facilities160Mpeople with access to lifesaving medicines15MCONTRIBUTIONS1 See map of collaborations at Where We Work.2 MSD for Mothers,Helping to reduce maternal mortality through investments to address the#1 driver of maternal deaths-postpartum hemorrhage.BEYOND INNOVATIONMSD POLICY PASSPORT57INVENTING FOR LIFENOBODY LEFT OUTSIDEEven in high-income countries,alarge num-ber of people are underserved by our health systems.This is particularly true for some of the most vulnerable and socially excluded groups such as LGBTI,sex workers,migrants,homeless,people who inject drugs,and prisoners.Underserved groups are often described as hard to reach,whereas,from their per-spective,it is frequently the health services that are hard to reach.Highly stigmatised,members of these communities face or-ganisational and legal barriers in accessing health care.In 2017,MSD launched the Nobody Left Oustide initiative with a group of NGOs representing marginalised communities.These organisations work together to identify shared challenges,discuss lessons learned through years of engagement,and seek integrated solutions to improve access to healthcare for the communities of people they represent.THE WORK OF NOBODY LEFT OUTSIDE SPEAKS SO STRONGLY TO THE PRINCIPLES OF WHAT WHO EUROPE STANDS FOR.WE HAVE A COMMON PURPOSE TO WORK TOWARDS INCLUSIVE AND ACCESSIBLE HEALTH SYSTEMS THAT PROVIDE CARE TO ALL THOSE WHO NEED IT.Dr Hans Kluge,Director General,WHO Europe,28February 2023.PUBLICATIONS AND EVENTSEU HEALTH THEMATIC NETWORK 2019HEALTH SERVICE CHECKLISTOPEN LETTERS&OP-EDSSee nobodyleftoutside.eu for more information about these initiatives,and NLO founding organisations.PHOTOEXHIBITIONBEYOND INNOVATIONMSD POLICY PASSPORT58INVENTING FOR LIFEBEYOND INNOVATIONMSD POLICY PASSPORT58INVENTING FOR LIFEHealth literacy empowers patients and citizens to play amore active role with regard to their health.Health literacy is the ability to read,under-stand and act on health information.Over the years,MSD has been involved in anum-ber of initiatives to promote better health through health literacy initiatives.1 Kickbusch,Ilona,Pelikan,Jrgen M.,Apfel,Franklin&Tsouros,Agis.(2013).Health Literacy.WHO Regional Office for Europe.According to the European Health Literacy Survey,nearly half of all Europeans have inadequate and problematic health literacy skills.1 Limited health literacy in Europe is thus not just a problem of a minority of the population,in contrast,it is a public health challenge.HEALTH LITERACY IS ASTRONGER PREDIC-TOR OF ANINDIVIDUALS HEALTH STATUS THAN AGE,INCOME,EMPLOYMENT STATUS,EDUCATION LEVEL,RACE OR ETHNIC GROUP.Dr.Barry D.Weiss,Help Patients Understand Health Literacy Educational Toolkit,American Medical Association,2007.HEALTH LITERACY SOURCES&DRIVERSHEALTH LITERACY HEALTH OUTCOMES SOCIAL DETERMINANTSNEWS MEDIAHEALTHCARE PROFESSIONALSPATIENTS GROUPSEDUCATORSPHARMA INDUSTRYMAKE THE HEALTHY CHOICESTAYING HEALTHYREDUCED RISK BEHAVIOURSOPTIMISED THERAPYEFFICIENT USE OF CARE SERVICESREDUCED REPEAT PROCEDURESLOWER OVERALL COSTIMPROVED QUALITY OF LIFEFAMILY&CARE GIVERSHEALTH LITERACYBEYOND INNOVATIONMSD POLICY PASSPORT59INVENTING FOR LIFEABOUT MSDMSD POLICY PASSPORT59INVENTING FOR LIFEFor over 130 years,weve been guided by the view that great medicines and vaccines change the world.MSD is a research-intensive global healthcare leader developing innovative medicines,vaccines,and animal health products.We are pushing the boundaries of science with the hope and expectation that the medicines and vaccines we invent will lead to better health for society for gener-ations to come.We also demonstrate our commitment to increasing access to healthcare through far-reaching access programmes that bring our products to millions of people and animals who need them.For more,see our ESG report.1 MSD operates in more than 140 countries to deliver innovative health solutions.Worldwide,MSD employs more than 69,000 people,of which 19,500 are based in Europe(a third of our workforce)across 33 locations,representing over 90 nationalities.1 See MSD Environmental,Social&Governance progress report 20212022.Our values guide everything we do,and they serve as the foundation of trust.We recog-nise that avariety of perspectives is crucial to encourage innovation.We therefore strive for equal representation across our com-pany,while promoting the best talent as reflected by our 50/50 gender balance.MSD is focused on addressing many of the worlds unmet medical needs.Our journey to discovery is guided by science and in-spired by patients.By dedicating over 20%of our revenues to R&D(22.6%in 2022),we are pioneering new approaches across a broad range of diseases,including cancer,infectious disease,and cardio-metabolic disorders to cite a few.ABOUT MSDMSD IN NUMBERS IN EUROPEMORE THAN 19,500 EMPLOYEES ABOUT ONE THIRD OF OUR TOTAL WORK FORCE WITH A50/50 GENDER BALANCEPRESENT IN 26 EU MEMBER STATESWITH 21 MANUFACTURING SITESPHARMACEUTICAL INNOVATION IS ONE OF THE GREATEST ACHIEVEMENTS OFOUR SOCIETIESINVENTING FOR LIFEFOR PATIENTSFOR ECONOMIESFOR HEALTHCAREFOR SOCIETYPATIENTS LIVE LONGER,HEALTHIER,MORE PRODUCTIVE LIVESPHARMA COMPANIES DRIVE HIGH-VALUE ECONOMIC GROWTHNEW TREATMENTS MAKES HEALTH SYSTEMS MORE RESPONSIVE AND RESILIENTBETTER HEALTH IS A PILLAR OF OUR AGING SOCIETIES
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20222031Intersectoral global action plan on epilepsy and other neurological disorders20222031Intersectoral global action plan on epilepsy and other neurological disordersIntersectoral global action plan on epilepsy and other neurological disorders 20222031ISBN 978-92-4-007662-4(electronic version)ISBN 978-92-4-007663-1(print version)World Health Organization 2023Some rights reserved.This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence(CC BY-NC-SA 3.0 IGO;https:/creativecommons.org/licenses/by-nc-sa/3.0/igo).Under the terms of this licence,you may copy,redistribute and adapt the work for non-commercial purposes,provided the work is appropriately cited,as indicated below.In any use of this work,there should be no suggestion that WHO endorses any specific organization,products or services.The use of the WHO logo is not permitted.If you adapt the work,then you must license your work under the same or equivalent Creative Commons licence.If you create a translation of this work,you should add the following disclaimer along with the suggested citation:“This translation was not created by the World Health Organization(WHO).WHO is not responsible for the content or accuracy of this translation.The original English edition shall be the binding and authentic edition”.Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization(http:/www.wipo.int/amc/en/mediation/rules/).Suggested citation.Intersectoral global action plan on epilepsy and other neurological disorders 20222031.Geneva:World Health Organization;2023.Licence:CC BY-NC-SA 3.0 IGO.Cataloguing-in-Publication(CIP)data.CIP data are available at http:/apps.who.int/iris.Sales,rights and licensing.To purchase WHO publications,see https:/www.who.int/publications/book-orders.To submit requests for commercial use and queries on rights and licensing,see 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preference to others of a similar nature that are not mentioned.Errors and omissions excepted,the names of proprietary products are distinguished by initial capital letters.All reasonable precautions have been taken by WHO to verify the information contained in this publication.However,the published material is being distributed without warranty of any kind,either expressed or implied.The responsibility for the interpretation and use of the material lies with the reader.In no event shall WHO be liable for damages arising from its use.Photos credits:Cover Unsplash/Terry Boynton.Page viii Unsplash/Jixiao Huang.Page 6 Unsplash/Nathan Anderson.Page 9 Unsplash/Joice Kelly.Page 19 Unsplash/Robert Collins.Page 31 Unsplash/William Krause.Page 49 Unsplash/Cdc Aeh.Page 57 Unsplash/Dragon Pan.Layout by Caf.art.briiForeword.vBackground.1Overview of the global situation.2Scope.4Vision.7Goal.7Strategic objectives.8Guiding principles.12Strategic objective 1:Raise policy prioritization and strengthen governance.201.1 Advocacy.131.2 Policy,plans and legislation.151.3 Financing.17Strategic objective 2:Provide effective,timely and responsive diagnosis,treatment and care.202.1 Care pathways.212.2 Medicines,diagnostics and other health products.242.3 Health workers capacity-building,training and support.272.4 Carer support.29Strategic objective 3:Implement strategies for promotion and prevention.323.1 Promoting healthy behaviour across the life course.333.2 Infectious disease control.353.3 Preventing head/spinal trauma and associated disabilities.373.4 Reducing environmental risks.393.5 Promotion of optimal brain development in children and adolescents.41ContentsiiiStrategic objective 4:Foster research and innovation and strengthen information systems.444.1 Investment in research.454.2 Data and information systems.47Strategic objective 5:Strengthen the public health approach to epilepsy .505.1 Access to services for epilepsy.515.2 Engagement and support for people with epilepsy.545.3 Epilepsy as an entry point for other neurological disorders.55Annex 1:Resolutions and global commitments relevant to neurological disorders.58Annex 2:Indicators for measuring progress towards defined targets of the Intersectoral Global Action Plan on Epilepsy and Other Neurological Disorders 2022 2031.62ivIntersectoral global action plan on epilepsy and other neurological disorders 20222031ForewordEvery year,neurological disorders such as stroke,epilepsy and dementia kill nine million people,putting them among the worlds leading causes of death and disability.Marginalized populations and those living in communities with poor health systems are particularly vulnerable.The burden of neurological disorders is compounded by stigma and discrimination,which can hamper life opportunities,increase the risk of poverty,and lead to difficulties in accessing care.In fact,many neurological disorders are preventable,and much progress is being made in treatments and research.The Intersectoral global action plan on epilepsy and other neurological disorders,developed in 2022 at the request of the World Health Assembly,is a blueprint of how to bring these advances to health systems and communities,to improve the lives of people with neurological disorders.Multiple stakeholders were involved in developing the action plan,including people with lived experience,governments,civil society organizations,researchers and the private sector.All contributed their keen insights on what needs to change in addressing neurological disorders.The action plan conceptualizes several strategic areas in which the status quo should be addressed.These include prioritizing neurological disorders within health systems and strengthening their governance;providing effective,timely and responsive diagnosis,treatment and care;developing and implementing strategies for promotion and prevention;fostering research and innovation while strengthening information systems;and strengthening the public health approach to epilepsy.The ten global targets will help measure progress towards achieving the action plans objectives.The plans ambitious scope is designed to address the long-standing neglect of neurological disorders.Member States,national and international partners,and WHO must work together to realize the action plans vision of a world in which brain health is valued and protected across the life course;neurological disorders are prevented,diagnosed and treated;premature mortality and morbidity are avoided;and people affected by neurological disorders have equal rights,opportunities,respect and autonomy.Dr Tedros Adhanom Ghebreyesus Director-General World Health OrganizationvviBackground1 The consultative process that was followed in order to develop the action plan is described here:https:/www.who.int/news/item/28-04-2022-draft-intersectoral-global-action-plan-on-epilepsy-and-other-neurological-disorders-2022-20311.In November 2020,the Seventy-third World Health Assembly adopted resolution WHA73.10 requesting the Director-General of WHO,inter alia,to develop a 10-year intersectoral global action plan on epilepsy and other neurological disorders,in consultation with Member States,in order to promote and support a comprehensive,coordinated response across multiple sectors1.2.The intersectoral global action plan on epilepsy and other neurological disorders 20222031 aims to improve access to care and treatment for people living with neurological disorders,while preventing new cases and promoting brain health and development across the life course.It seeks to support the recovery,well-being and participation of people living with neurological conditions,while reducing associated mortality,morbidity and disability,promoting human rights,and addressing stigma and discrimination through interdisciplinary and intersectoral approaches.3.The intersectoral global action plan on epilepsy and other neurological disorders 20222031 builds on previous global resolutions,decisions,reports and commitments,including resolution WHA68.20 on the global burden of epilepsy and the need for coordinated action at the country level to address its health,social and public knowledge implications.A number of preventive,pharmacological and psychosocial approaches are shared by epilepsy and other neurological disorders.This sharing of strategies and approaches(i.e.,synergies)can serve as valuable entry points for accelerating and strengthening services and support for epilepsy and other neurological disorders.1Overview of the global situation2 Global,regional,and national burden of neurological disorders,19902016:a systematic analysis for the Global Burden of Disease Study 2016.Lancet Neurol.2019;18(5):459480.doi:10.1016/S1474-4422(18)30499-X.See also Global health estimates 2020:Disease burden by cause,age,sex by country and by region,20002019.Geneva:World Health Organization;2020.3 Developmental disabilities among children younger than 5 years in 195 countries and territories,19902016:a systematic analysis for the Global Burden of Disease Study 2016.Lancet.2018;6(10):E100E1121.doi:10.1016/S2214-109X(18)30309-7.4 Epilepsy:a public health imperative.Geneva:World Health Organization;2019.5 J Olesen 1,A Gustavsson,M Svensson,H-U Wittchen,B Jnsson,CDBE2010 study group,et al.The economic cost of brain disorders in Europe.Eur J Neurol.2012;19(1):155162.doi:10.1111/j.1468-1331.2011.03590.x.6 Global status report on the public health response to dementia.Geneva:World Health Organization;2021.7 Feigin VL,Vos T,Nichols E,Owolabi MO,Carroll WM,Dichgans M,et al.The global burden of neurological disorders:translating evidence into policy.Lancet Neurol.2020 Mar;19(3):255-265.doi:10.1016/S1474-4422(19)30411-9.4.Disorders of the nervous system are the leading cause of DALYs and the second leading cause of death globally,accounting for 9 million deaths per year.The five largest contributors of neurological DALYs in 2016 were stroke(42.2%),migraine(16.3%),dementia(10.4%),meningitis(7.9%)and epilepsy(4.9%).2 Globally in 2016,52.9 million children younger than 5 years had developmental disabilities and 95%of these children lived in low-and middle-income countries.3 5.The high burden associated with neurological disorders is compounded by profound health inequities.For example,nearly 80%of the 50 million people with epilepsy live in low-and middle-income countries,where treatment gaps exceed 75%in most low-income countries and exceed 50%in most middle-income countries.4 Disabilities associated with neurological conditions inordinately affect women,older people,those living in poverty,rural or remote areas and other vulnerable populations.Women are also often disproportionally affected by neurological disorders,such as dementia,migraine and multiple sclerosis.Children from underprivileged households,indigenous populations,ethnic minorities and internally displaced or stateless persons,refugees and migrants are also at significantly higher risk of experiencing disability associated with neurological conditions.6.Neurological disorders lead to increased costs for governments,communities,families and individuals,as well as to loss of productivity for economies.In 2010,brain disorders were estimated to cost 798 billion in Europe alone.5 In 2019,the total global societal cost of dementia was estimated at US$1.3 trillion,equivalent to 1.5%of global GDP.67.Many neurological conditions are preventable,including 25%of the global burden of epilepsy cases.7 Numerous 2Intersectoral global action plan on epilepsy and other neurological disorders 20222031determinants,including environmental risk factors and protective factors,are known to impact brain development in early life and brain health across the life course.Protective factors for brain development in early life include components such as education,social connection and support,healthy diets,sleep and physical activity.8.Worldwide,people living with neurological disorders and associated disabilities continue to experience discrimination and human rights violations.For this reason,the intersectoral global action plan on epilepsy and other neurological disorders 20222031 is underpinned by a human rights perspective that is grounded in the International Covenant on Civil and Political Rights,the International Covenant on Economic,Social and Cultural Rights,the Convention on the Rights of Persons with Disabilities,the Convention on the Rights of the Child and other relevant international and regional human rights instruments.9.Supporting the appropriate health system building blocks is particularly important for improving the quality of life of people living with neurological disorders.The implementation of appropriate policy and legislative frameworks is crucial and should aim to promote quality care,provide financial and social protection benefits(including protection from out-of-pocket expenditures)and ensure respect and fulfilment of the rights of people with neurological disorders.Comprehensive responses aimed at tackling neurological disorders should be firmly grounded in a social and economic determinants of health approach.8 ATLAS Country Resources for Neurological Disorders,second edition.Geneva:World Health Organization;2017.9 ATLAS Country Resources for Neurological Disorders,second edition.Geneva:World Health Organization;2017.10 WHOs Scientific Brief on Neurology and COVID-19(https:/www.who.int/publications/i/item/WHO-2019-nCoV-Sci-Brief-Neurology-2021.1,accessed 6 April 2022).10.Health systems have not yet adequately responded to the burden of neurological disorders.While approximately 70%of people with neurological disorders live in low-and middle-income countries,8 their needs are poorly recognized,with only 28%of low-income countries reporting that they have a dedicated policy for neurological disorders.5 Currently,the number of health workers specialized in neurological health is insufficient to tackle the treatment gaps globally.The median neurological workforce(defined as the total number of adult neurologists,neurosurgeons and child neurologists)in low-income countries is 0.1 per 100 000 people,compared to 7.1 per 100 000 people in high-income countries.911.The ongoing COVID-19 pandemic highlights the relevance of neurology to global public health and its significance in broader global health dialogues.Disruption of services,medication inaccessibility,interruption in vaccination programmes and increased mental health issues have added to the burden of those with neurological disorders.More directly,neurological manifestations of COVID-19 infection are present in both the acute stage and the post-COVID-19 condition.Certain underlying neurological conditions represent a risk factor for hospitalization and death due to COVID-19,especially for older adults.10 The intersectoral global action plan on epilepsy and other neurological disorders 20222031 represents an unprecedented opportunity to address the impact of neurological disorders through a comprehensive response throughout and following the pandemic.3Overview of the global situationScope12.The term“neurological disorders”is used to denote conditions of the central and peripheral nervous systems that include epilepsy;headache disorders(including migraine);neurodegenerative disorders(including dementia and Parkinsons disease);cerebrovascular diseases(including stroke);neuroinfectious/neuroimmunological disorders(including meningitis,HIV,neurocysticercosis,cerebral malaria and multiple sclerosis);neuromuscular disorders(including peripheral neuropathy,muscular dystrophies and myasthenia gravis);neurodevelopmental disorders(including autism spectrum disorder and congenital neurological disorders);traumatic brain and spinal cord injuries;and cancers of the nervous system.While some neurological disorders are rare,they are still responsible for high morbidity and mortality.13.In line with WHOs International Classification of Functioning,Disability and Health,functioning and disability are considered the result of interactions between neurological conditions and contextual factors across the life course.For this reason,a holistic approach is required to account for medical,individual,social and environmental influences.14.Addressing the needs of people with neurological conditions begins with increasing understanding and awareness and addressing stigma and discrimination,which impact well-being and act as barriers to seeking health care.Rather than adopting a disease-specific structure,the intersectoral global action plan on epilepsy and other neurological disorders 20222031 uses an integrated,person-centred framework for the prevention,diagnosis,treatment and care of people with neurological disorders.The prevention of neurological disorders rests upon the promotion and development of optimal brain health across the life course.Good brain health is a state in which every individual can learn,realize their potential and optimize their cognitive,psychological,neurophysiological and behavioural responses,while adapting to changing environments.4Intersectoral global action plan on epilepsy and other neurological disorders 2022203115.Other relevant areas or disciplines of public health are closely intertwined with and impact neurological disorders,such as mental health,violence,injuries,noncommunicable and infectious diseases,and environmental health.Many neurological conditions are woven into other WHO strategies,action plans or World Health Assembly resolutions.In addition,neurological disorders have strategic links to health systems and UHC,including the full range of essential health services,from health promotion to prevention,treatment,rehabilitation and palliative care.The intersectoral global actionplan on epilepsy and other neurological disorders 20222031 is consistent with the 2030 Agenda and the SDGs and takes a life course approach,recognizing that there are strong linkages between maternal,newborn,child and adolescent health,reproductive 11 The list of resolutions and global commitments relevant to neurological disorders is available at https:/www.who.int/news/item/12-01-2022-draft-intersectoral-global-action-plan-on-epilepsy-and-other-neurological-disorders-2022-2031(accessed 6 April 2022).12 A summary of global targets and indicators is available at https:/www.who.int/news/item/12-01-2022-draft-intersectoral-global-action-plan-on-epilepsy-and-other-neurological-disorders-2022-2031(accessed 28 February 2022).health and ageing,and brain health and neurological disorders.16.Linking the intersectoral global action plan on epilepsy and other neurological disorders 20222031 with other global commitments11 reflects WHOs responsiveness to focusing on the impact on peoples health and working in a cohesive and integrated manner.17.The intersectoral global action plan on epilepsy and other neurological disorders 20222031 provides the vision,goal,guiding principles and strategic objectives with their action areas and targets.It suggests a range of proposed actions for Member States,the WHO Secretariat and international and national partners.While targets are defined for achievement globally,each Member State can be guided by these to set its own national targets,taking into account national circumstances and challenges.1256Goal19.The goal of the intersectoral global action plan on epilepsy and other neurological disorders 20222031 is to reduce the stigma,impact and burden of neurological disorders,including their associated mortality,morbidity and disability,and to improve the quality of life of people with neurological disorders,their carers and families.20.In order to achieve the vision and goal defined above,the prevention,treatment and care of epilepsy and other neurological disorders should be strengthened,wherever possible,utilizing entry points and synergies to achieve the best results for all.18.The vision of the intersectoral global action plan on epilepsy and other neurological disorders 20222031 is a world in which:brain health is valued,promoted and protected across the life course;neurological disorders are prevented,diagnosed and treated,and premature mortality and morbidity are avoided;and people affected by neurological disorders and their carers attain the highest possible level of health,with equal rights,opportunities,respect and autonomy.Vision7Strategic objectives21.The intersectoral global action plan on epilepsy and other neurological disorders 20222031 has the following strategic objectives:Strengthen the public health approach to epilepsy Foster research and innovation and strengthen information systemsImplement strategies for promotion and preventionRaise policy prioritization and strengthen governanceProvide effective,timely and responsive diagnosis,treatment and care235418Intersectoral global action plan on epilepsy and other neurological disorders 202220319Guiding principles22.The intersectoral global action plan on epilepsy and other neurological disorders 20222031 relies on the following six guiding principles.People-centred PHC and UHCAll people with neurological disorders and their families should participate in and have equitable access,without discrimination or risk of financial hardship,to a broad range of promotive,preventive,diagnostic,treatment,rehabilitation,palliative and social care,as well as to essential,effective,safe,affordable and quality medicines and other health products.aIntegrated approach to care across the life courseIntegrated care for neurological disorders is essential for achieving better promotion,prevention and management outcomes.This is particularly important given the multimorbidity of neurological disorders with one another and with other health conditions,which are often linked by common preventable risk factors.Care for neurological disorders requires close alignment to other existing services and programmes,in line with the Framework on Integrated,People-centred Health Services1,as well as consideration of the health and social care needs at all stages of the life course.Evidence-informed policy and practiceScientific evidence and/or best practices enable the development of public health policies and interventions for the prevention and management of neurological disorders that are cost-effective,sustainable and affordable.This includes existing knowledge,real-world,practice-based evidence,the preferences of people with neurological disorders and culture-based experience,as well as the translation of new evidence into policy and practice that work towards finding disease-modifying treatments or cures,effective prevention and innovative models of care.bc10Intersectoral global action plan on epilepsy and other neurological disorders 20222031Intersectoral actionA comprehensive and coordinated response to neurological disorders requires partnerships and collaboration among all stakeholders.Achieving such collaboration requires leadership at governmental levels;clear delineation of roles and responsibilities among stakeholders;innovative coordination mechanisms,including publicprivate partnerships;engagement of all relevant sectors,such as health,social services,education,environment,finance,employment,justice and housing;and partnerships with civil society,academia,private sector actors and associations representing those with neurological disorders.dEmpowerment and involvement of persons with neurological disorders and their carersThe social,economic and educational needs and freedoms of persons and families affected by neurological disorders should be promoted,prioritized and protected.People with neurological disorders,their carers,local communities and organizations that represent them should be empowered through engagement and consultative mechanisms in care planning and service delivery as well as in policy and legislation development,programme implementation,advocacy,research,monitoring and evaluation.Gender,equity and human rightsMainstreaming a gender perspective on a system-wide basis in all efforts to implement public health responses to neurological disorders is central to creating inclusive,equitable and healthy societies.Universal access to interventions for people with neurological disorders and their carers,as well as a focus on reaching the most vulnerable population groups,including migrants,children,women,older people,those living in poverty and those in emergency settings,are crucial to realizing the rights of people with neurological disorders and reducing stigma and discrimination.The implementation of the intersectoral global action plan on epilepsy and other neurological disorders 20222031 must explicitly address disparities specific to each national context and reduce inequalities.ef1 See document A69/39;see also Framework on integrated people-centred health services(IPCHS)(https:/www.who.int/teams/integrated-health-services/clinical-services-and-systems/service-organizations-and-integration,accessed 25 April 2022).11Guiding principlesStrategic objective 1:Raise policy prioritization and strengthen governance23.A broad public health approach grounded in principles of UHC and human rights is needed to improve the care and quality of life of people with neurological disorders.To achieve this,strengthening governance for neurological disorders involves ensuring that strategic policy frameworks are established and supported by effective oversight,regulatory and accountability mechanisms.24.Lack of knowledge and awareness needs to be addressed at all levels of society,including among government representatives,people with neurological disorders and other stakeholders,in order to change the major structural and attitudinal barriers to achieving positive brain health outcomes,reduce stigma and discrimination,promote the human rights of people with neurological disorders and improve their care and quality of life.25.Effective advocacy can influence political commitment and mobilize resources to support policy prioritization of neurological disorders,including interlinkages with achieving broader international commitments such as those outlined in the 2030 Agenda and the SDGs and the Convention on the Rights of Persons with Disabilities.26.The integration and mainstreaming of neurological disorders in relevant evidence-informed national policies,legislation and guidelines within and beyond the health sector,including in education,social protection and employment,is important to meet the multifaceted needs of people with neurological disorders.27.Health financing is a core function of health systems that can enable progress towards achieving UHC.It involves designing and implementing policies to ensure effective health system governance and service arrangements,including through raising revenue,pooling funds and purchasing services(such as the allocation of resources to health service providers)in order to support access to timely,affordable,resilient and quality services,support and treatment for neurological disorders.Intersectoral global action plan on epilepsy and other neurological disorders 2022203112Global targets for strategic objective 1 Global target 1.175%of countries will have adapted or updated existing national policies,strategies,plans or frameworks to include neurological disorders by 2031.Global target 1.2100%of countries will have at least one functioning awareness campaign or advocacy programme for neurological disorders by 2031.1.1 Advocacy28.Advocacy represents the first step in raising awareness and better public understanding of brain health and neurological disorders.It is necessary to improve neurological care,reduce stigma and discrimination,prevent violations and promote human rights.Advocacy also includes public and political awareness of the burden and impact of neurological disorders and the dissemination of evidence-based interventions,including the promotion of brain health and the prevention and treatment of neurological disorders.29.Effective advocacy,including public awareness campaigns,requires tailoring approaches to reflect each countrys cultural and social context.In addition,it requires involving people with neurological disorders in the centre of all advocacy efforts to achieve desired health and social outcomes.Public awareness campaigns should include information on the promotion and prevention of neurological disorders and should be designed for people living with neurological disorders.30.Proposed actions for Member States(a)Engage all relevant stakeholders,such as advocacy experts,health professionals and people with neurological disorders and their carers,to develop awareness-raising programmes to improve the understanding of neurological disorders,promote brain health and prevent and manage neurological conditions across the life course,including the identification of barriers to health seeking behaviours.(b)Establish national and regional collaboration,knowledge translation and exchange mechanisms to raise awareness of the burden of disease associated with neurological disorders and the availability of and access to appropriate evidence-based promotive,preventive,management and care services for people with neurological disorders.13Strategic objective 1:Raise policy prioritization and strengthen governance(c)Lead and coordinate intersectoral advocacy strategies for reducing stigma and discrimination and promoting the human rights of people with neurological disorders across the life course,including vulnerable groups.Integrate these within broader health promotion strategies,such as flexible educational and work environments for people with neurological disorders.30.Proposed actions for Member States(continued)31.Actions for the Secretariat(a)Engage and include people with neurological disorders,their carers and families in decision-making within WHOs own processes on issues that concern them,through meaningful and structured mechanisms.(b)Provide technical support and advocacy tools for stigma reduction to help policymakers at national,regional and global levels to recognize the need to prioritise neurological disorders and integrate them into policies and plans.(c)Provide support and guidance to Member States in meaningfully engaging people with neurological disorders across all age groups by providing a convening platform,generating and leveraging evidence-based information and best practices,and engaging lived experience in decision-making processes.32.Proposed actions for international and national partners(a)In partnership with other stakeholders,advocate for increasing the visibility of neurological disorders in the SDGs and other global commitments,as well as for prioritizing neurological disorders in policy agendas by raising awareness of the social and economic impacts of neurological disorders and the need for an integrated response across the life course and within health care systems.(b)Support advocacy efforts for protecting the human rights of people with neurological disorders,redressing inequities in access to neurological services for vulnerable populations and reducing stigma and discrimination.Ensure that people with neurological disorders are equally included in activities of the wider community in order to foster cultural,social and civic participation and enhance autonomy.(c)Provide a platform for dialogue between associations and organizations of people with neurological disorders and their carers,health and social workers,government sectors and other relevant actors at international,regional and national levels,while including young people and older people and ensuring gender-balanced representation.Engage with different sectors,such as the transportation,education,judicial,financial and employment sectors,in advocacy efforts for increasing the independence and autonomy of people with neurological disorders.Intersectoral global action plan on epilepsy and other neurological disorders 20222031141.2 Policy,plans and legislation33.The development of comprehensive intersectoral policies,plans and legislation based on scientific evidence and aligned with international human rights standards strengthens governance for neurological disorders and ensures that the complex needs of people with neurological disorders are addressed within the context of each country.34.Collaboration between people with neurological disorders,technical experts who generate evidence,policymakers and programme managers who formulate,adapt and implement policies,plans,guidelines and legislation,as well as health professionals who provide care and services to people with neurological disorders,is essential to facilitate the development and implementation of evidence-based policies and plans across sectors.35.Given the interlinkages between neurological disorders and other public health areas,numerous opportunities exist to integrate neurological disorders into policies and plans for these disciplines,for instance in the areas of noncommunicable and communicable diseases,mental health,maternal,children and adolescent health,ageing and disability.36.Legislation that impacts the lives of people with neurological disorders,for example people with epilepsy,is frequently outdated and fails to protect and promote their human rights.It is crucial to update all laws relevant to persons with neurological disorders,such as those related to education,employment and womens rights,and ensure that they are more inclusive.37.Proposed actions for Member States(a)Develop or review,update,strengthen and implement national and/or subnational policies,plans and legislation based on context-specific evidence relating to neurological disorders,whether as separate instruments or by integrating them into other planned intersectoral actions for NCDs,mental health,disability and other relevant areas across the care continuum of all ages.Formulate and implement national policies and legislation in consultation with people with neurological disorders,their carers and other stakeholders in order to promote and protect their rights and prevent stigma and discrimination.(b)Establish monitoring and accountability mechanisms for resource allocation,including focal points,units or functional divisions responsible for neurological disorders within the health ministry(or equivalent body).Strategic objective 1:Raise policy prioritization and strengthen governance15(c)Review disability and other relevant policies and laws to be more inclusive of people with neurological disorders,including by reviewing criteria to access disability benefits;providing funding to support people with disabilities in employment;establishing quota systems for active hiring;making working environments more accessible with employment regulations and labour laws that govern the public and private sectors;and strengthening mechanisms to address claims and complaints related to human rights violations and discrimination against people with neurological disorders through impartial recourse processes.38.Actions for the Secretariat:Offer technical support,tools and guidance to Member States and policymakers to:37.Proposed actions for Member States(continued)(a)share knowledge and evidence-based best practices to inform the development,strengthening,implementation and evaluation of national and/or subnational policies,plans and legislation that are aligned with international human rights standards for an integrated,intersectoral response to neurological disorders;(b)strengthen accountability mechanisms and strategies for resolving claims and complaints to address human rights violations and discrimination that are related to people with neurological disorders,for example in employment,access to education,driving,fertility and womens rights;(c)adopt legislation to ensure universal access to financial,social and disability benefits for people with neurological disorders and their carers;(d)provide assistance in outlining mechanisms that proactively encourage and support the active participation of people with neurological disorders in all aspects of policy-making,planning and financing services;and(e)provide ongoing monitoring,guidance and technical support to Member States in implementing the intersectoral global action plan on epilepsy and other neurological disorders 20222031,with the help of WHO regional and country offices across all levels.39.Proposed actions for international and national partners(a)Actively engage stakeholders across sectors to inform the development and implementation of evidence-based policies,plans and legislation,paying explicit attention to the human rights of people with neurological disorders and their carers and preventing stigma and discrimination.(b)Support the creation and strengthening of associations and organizations of people with neurological disorders,their families and carers,and foster their collaboration with other organizations as partners in the implementation of policies for neurological disorders.Intersectoral global action plan on epilepsy and other neurological disorders 202220311639.Proposed actions for international and national partners(continued)(c)Facilitate knowledge exchange and dialogue among associations of people with neurological disorders,their carers and families and their organizations,as well as health and social workers and governments,to ensure that Convention on the Rights of Persons with Disabilities principles such as empowerment,engagement and inclusion are embedded in legislation in order to promote the health of people with disabilities that are associated with neurological disorders.1.3 Financing40.Neurological disorders lead to increased costs for governments,communities,families and individuals,as well as productivity losses for economies,many of which could be remedied by prevention,early detection and timely treatment.People with neurological disorders and their families face significant financial hardship due to health and social care costs,as well as reduced or foregone income.This is compounded by a lack of universal health insurance across all countries,with limited investment and resources to address neurological conditions.41.Appropriately funded policies and programmes are required in order to ensure access to prevention,diagnosis,treatment and care for people with neurological disorders and their carers and reduce the financial impact of out-of-pocket health and social care costs.This investment will be offset by a reduction in the cost of neurological disability and will ultimately reduce long-term costs for governments.42.Proposed actions for Member States(a)Support sustainable funding for policies,plans and programmes for the prevention and management of neurological disorders,based on an integrated response across the life course,through dedicated domestic budgetary allocations,efficient and rational utilization of resources,voluntary innovative financing mechanisms and other means,including multilateral,bilateral,pooled funding and publicprivate partnerships.(b)Produce and/or utilize the most recent data on the epidemiological and economic burden of neurological disorders,as well as the economic evidence base for investment and the projected costs of intervention scale-up in order to make informed decisions on budgets that are proportionate to the scale of the burden in the country and to allocate scarce resources optimally.(c)Develop financial and social protection mechanisms,including national health insurance plans and social security benefits,for addressing the direct and indirect costs related to accessing health care(such as transportation costs)and support affordable and accessible care for persons with neurological conditions,their carers and families.Strategic objective 1:Raise policy prioritization and strengthen governance1743.Actions for the Secretariat(a)Promote collaboration and knowledge exchange at international,regional,and national levels to strengthen knowledge on the socioeconomic impact of investment for neurological disorders.(b)Offer technical support,tools and guidance to Member States in strengthening their national capacity to engage in intersectoral resource planning,budgeting and expenditure monitoring on neurological disorders.(c)Provide guidance for structured approaches to generating national investment for neurological disorders and brain health promotion,care and protection,in line with other existing investment case methods for supporting governments choices.44.Proposed actions for international and national partners(a)Support Member States in mobilizing sustainable financial resources and identifying functional gaps in resource allocation in order to support the implementation,monitoring and evaluation of national and/or subnational policies,programmes and services for neurological disorders.(b)Support the participation of people with neurological disorders and their carers in decision-making processes related to international financing mechanisms.(c)Support the development of innovative funding models,such as an international assistance fund to subsidize and fund the costs of diagnostics and therapeutics and offset the costs associated with referral,for example for travel and specialist services and interventions.(d)Support the accountability and efficiency of resource use in health care systems in order to allocate scarce resources optimally and improve quality and efficiency with minimum wastage of resources.Intersectoral global action plan on epilepsy and other neurological disorders 20222031181945.Neurological disorders are important causes of mortality,morbidity and disability.They require concerted intersectoral efforts to address the needs of people at risk of,or living with,neurological disorders by providing them with equitable access to effective health care and community-based,social,educational and vocational interventions and services.46.Integrating care for neurological disorders into primary,secondary and tertiary health care levels and providing essential medicines,diagnostics,training and support for health care workers,carers and families of people with neurological disorders are actions consistent with the principles of UHC,the 2030 Agenda and the SDGs.47.A strong health system that embraces a people-centred and coordinated care approach and is directed towards ensuring effective,timely and responsive diagnosis,treatment and care over sustained periods is needed to improve the well-being and quality of life of people with neurological disorders,as well as to avoid complications,reduce hospitalization and costly interventions and prevent premature death and disability.Strategic objective 2:Provide effective,timely and responsive diagnosis,treatment and careIntersectoral global action plan on epilepsy and other neurological disorders 20222031202.1 Care pathways48.Developing interdisciplinary care for people with neurological disorders requires guidelines that are grounded in evidence-based protocols and practices,organization by stages of care and a life course approach.49.Services and care pathways,including access to quality emergency care,should be responsive to the needs of people with neurological disorders,their carers and families,who live in both urban and rural areas,and should be inclusive of vulnerable population groups,including socioeconomically disadvantaged individuals,children,older people,people affected by domestic and gender-based violence,prisoners,refugees,displaced populations and migrants,indigenous populations and other groups specific to each national context.50.A care pathway should be oriented to each stage of the life course,from pregnancy through early childhood to care for older adults.This includes continuing care for children and adolescents with neurological disorders as they adapt to the challenges of transitioning into adulthood.51.Neurological conditions impact peoples functioning and often reduce their mobility,communication,cognitive functioning and self-care,which requires rehabilitation.However,the rehabilitation needs for people with neurological disorders are largely unmet,with only 16%of countries reporting specialized neurorehabilitation services and only 17%reporting general rehabilitation units that offer neurorehabilitation.152.Due to the complex needs and high levels of dependency and morbidity of people with neurological disorders,a range of coordinated health and social care is essential,including interventions such as palliative care to provide relief from pain;psychosocial,spiritual and advance care planning support;and interventions to enhance their quality of life.53.When possible,care pathways should include neurosurgical facilities for the surgical procedures required for the care of neurological conditions such as tumours,epilepsy and acute ischaemic stroke.54.Continuity of care can be optimized using digital health solutions that foster greater information-sharing between providers,people with neurological disorder and their carers and allow for remote consultation through tele-health.Global target 2.175%of countries will have included neurological disorders in the UHC benefits package by 2031.Global targets for strategic objective 2Global target 2.280%of countries will provide the essential medicines and basic technologies required to manage neurological disorders in primary care by 2031.21Strategic objective 2:Provide effective,timely and responsive diagnosis,treatment and care55.Proposed actions for Member States(a)Develop evidence-based pathways of coordinated health and social services for people with neurological disorders across the life course within UHC in order to enable their access to quality care,when and where required.This includes integration at multiple levels of the health and social care system,use of interdisciplinary care teams,service directories and medical health records,and referral mechanisms.In particular:enhance equitable access to quality care for acute(emergency)and chronic neurological conditions;strengthen care at primary,secondary and tertiary levels,including medical and surgical facilities;develop community-based neurological services,with the involvement of other care providers such as traditional healers,and promote self-care;and promote continuity of care between providers and health system levels,including through referral and follow-up,ensuring that primary care services are supported by specialist services in hospitals and community health services with efficient referral and back-referral mechanisms.(b)Develop strategies to rationalize resources and enhance effective collaboration across public,private and nongovernmental actors through:the implementation of context-specific,innovative and integrated models of care,from diagnosis to end-of-life across health and social sectors;the promotion,implementation and scaling up of digital health solutions and technologies across health and social care;and the creation of interdisciplinary health and social care teams and networks and the capacity-building of health and social care professionals.(c)Review existing related services,such as those on mental health,maternal,newborn,child and adolescent health,immunization and other relevant communicable and NCD programmes in order to identify opportunities for the integration of prevention,early diagnosis and the management of neurological disorders and non-neurological comorbidities.Intersectoral global action plan on epilepsy and other neurological disorders 202220312255.Proposed actions for Member States(continued)(d)Promote equitable access to rehabilitation for disabilities associated with neurological conditions by strengthening health systems at all levels,from specialized inpatient settings through to community-delivered rehabilitation.(e)Develop new and/or strengthen existing services,guidance and protocols to support the implementation of early palliative care coordination and referral mechanisms,while also ensuring equitable access to palliative care for people with neurological disorders.(f)Proactively identify and provide appropriate care and support to population groups at particular risk for neurological disorders or who have poor access to services,such as socioeconomically disadvantaged individuals,older people and other groups specific to each national context,and promote the continuity of integrated care between paediatric and adult providers for adolescents with neurological disorders as they transition into adulthood.(g)In partnership with humanitarian actors,integrate support needs into emergency preparedness plans in order to enable access to safe and supportive services for people with pre-existing or emergency-induced neurological disorders such as traumatic injuries.(h)Empower people with neurological disorders and their carers to participate in service planning and delivery,and enable them to make informed choices and decisions about care that meets their needs by providing evidence-based,accessible information,including on pathways from detection and diagnosis to treatment(including self-care)and care access.56.Actions for the Secretariat(a)Provide guidance and technical support to Member States to identify priority areas for possible intervention and to integrate cost-effective interventions for neurological disorders,their risk factors and comorbidities into health systems and UHC benefit packages.(b)Provide technical support to Member States in documenting and sharing best practices of evidence-based standards of care across the life course,including service delivery and interdisciplinary care coordination,emphasizing prevention,diagnosis,treatment(including management of comorbid conditions),rehabilitation and palliative care for people with neurological disorders.(c)Offer technical assistance and policy guidance to support emergency preparedness and enable access to safe,supportive services for those with neurological conditions.Strategic objective 2:Provide effective,timely and responsive diagnosis,treatment and care2357.Proposed actions for international and national partners(a)Actively engage all relevant stakeholders across sectors,including people with neurological disorders,their carers and families,in order to inform the development and implementation of intersectoral and interdisciplinary care coordination and integrated neurological care pathways across the continuum,including prevention,diagnosis,treatment,rehabilitation and palliative care.(b)Facilitate knowledge exchange and dialogue to review and update health service strengthening efforts following humanitarian emergencies,in collaboration with relevant multilateral and regional agencies,organizations representing people with neurological disorders and other civil society organizations.(c)Generate evidence and develop tools to support programmes for providing access to integrated care for people with neurological disorders.(d)Facilitate initiatives,in partnership with relevant stakeholders,to support and encourage people with neurological disorders,their families and carers to access neurological care and services through evidence-based,user-friendly,technology-supported information and training tools such as iSupport1 and/or by establishing national helplines and websites with accessible information.2.2 Medicines,diagnostics and other health products58.Medicines,diagnostics and other health products,such as assistive technology,biological products,and cell and gene therapy,are essential for prevention,early diagnosis and treatment to reduce mortality and morbidity and improve the quality of life of people with neurological disorders.59.Essential medicines have a crucial role for both the prevention and treatment of neurological disorders.For example,medicines for multiple sclerosis exist that slow disease progression and improve the quality of life for many people,but their availability and affordability are limited in low-and middle-income countries.60.The use of medical devices,including imaging and in vitro diagnostics(e.g.,neuroimaging,lumbar puncture and microscopy)can reduce morbidity through early detection and by slowing disease progression.Even when effective diagnostic tools are available,they may not be affordable or accessible due to the limited availability of laboratory infrastructure,equipment and trained personnel.61.Assistive technology enables people to live healthy,productive,independent and dignified lives and reduce the need for formal health and support services,long-term care and the work of carers.Few people in need have access to assistive products due Intersectoral global action plan on epilepsy and other neurological disorders 2022203124to high costs,lack of awareness,availability,trained personnel,policy and financing.To increase access to assistive products for those who need them the most,they should be available at all levels of health services,especially primary care,and within UHC.62.The rapid production of new medications and molecules in certain neurological disorders is a model for other neurological or health conditions.Current obstacles to accessing treatment and affordability should be identified in order to pave the way and remove barriers to make future and upcoming medications for neurological conditions available and affordable.63.Proposed actions for Member States(a)Promote the inclusion,updating and availability of essential,effective,safe,affordable and quality medicines and health products for neurological disorders in national essential medicines lists,as guided by the WHO Model List of Essential Medicines,the WHO List of Priority Medical Devices for Management of Cardiovascular Diseases and Diabetes,the WHO List of Priority Medical Devices for Cancer Management and the WHO Priority Assistive Products List,while including access to controlled medicines and minimizing the risk of misuse.Identify key barriers to access across population groups(including in emergency settings)and strategies to systematically address these.(b)Promote the appropriate,transparent and sustainable use of essential medicines for the prevention and management of neurological disorders through measures such as quality assurance,preferential registration procedures,generic and biosimilar substitution,the use of international non-proprietary names and financial incentives,where appropriate.Optimize the training of health professionals,people with neurological disorders and their carers,including by using evidence-based strategies to address the treatment of comorbidities,adverse events and drug interactions such as those due to polypharmacy.(c)Enable the availability,access and use of appropriate relevant diagnostics as guided by the WHO Model List of Essential In Vitro Diagnostics,such as microscopy,electrophysiology,genetic testing and neuroimaging technology,for example computed tomography(CT)and magnetic resonance imaging(MRI).Improve infrastructure and train technicians and health care workers in the use of these technologies.Strategic objective 2:Provide effective,timely and responsive diagnosis,treatment and care2563.Proposed actions for Member States(continued)(d)Establish transparent regulatory frameworks,resources and capacity to ensure that quality,safety and ethical standards are met for health products and diagnostics such as biotherapeutic treatments,genetic testing,pre-implantation genetic testing and assistive products like hearing aids,wheelchairs and prostheses.(e)Improve the availability of life-saving medicines and health products for managing neurological disorders during humanitarian emergencies.64.Actions for the Secretariat(a)Accelerate action and offer technical support to Member States to increase equitable access to medicines,diagnostics and other health products for people with neurological disorders,including through the setting of norms and standards at a global level;evidence-based,context-specific regulatory guidance;good practices for standards-based procurement and manufacturing;and technical,legislative and regulatory training.(b)Update the WHO Model List of Essential Medicines,the WHO Model List of Essential In Vitro Diagnostics,the WHO Lists of Priority Medical Devices,the WHO Priority Assistive Products List and other relevant documents to ensure that they are appropriate for neurological conditions and that pathways are in place for the timely implementation and use of effective treatments and diagnostics.65.Proposed actions for international and national partners(a)Encourage all relevant stakeholders to engage in activities to promote efforts for improving access to affordable,safe,effective and quality medicines,diagnostics and other health products,such as neuroimaging.(b)Support the global,regional,intergovernmental,national and/or subnational strengthening of regulatory and procurement processes(including through pooled procurement,innovative health financing mechanisms and human resource capacity-building)in order to promote access to and appropriate use of medicines,diagnostics and other health products.(c)Encourage the involvement of people with neurological disorders and their carers in research,development and implementation processes for new medicines,diagnostics and other health products.Intersectoral global action plan on epilepsy and other neurological disorders 20222031262.3 Health workers capacity-building,training and support66.Achieving improved health outcomes depends greatly on the combination of an adequate neurological workforce(e.g.,adult neurologists,child neurologists,neurosurgeons);other health care providers,including but not limited to psychologists,psychiatrists,radiologists,physical therapists,occupational therapists and speech therapists;and competent health workers serving at the PHC level who are trained in identifying and managing neurological disorders.67.The training and education of an interdisciplinary workforce,including social care workers,rehabilitation specialists trained in neurological conditions,technicians(electrophysiological,imaging,laboratory),pharmacists,biomedical engineers,community health workers,family,carers and traditional healers,where appropriate,is required to support the delivery of person-centred care to people with neurological disorders,reduce their mortality and morbidity and improve their quality of life.68.Proposed actions for Member States(a)Identify and apply context-appropriate evidence in order to establish:appropriately resourced programmes and policies to address projected health workforce needs for the future in light of demographic changes,increasing ageing populations and the prevalence of diseases such as dementia,stroke and Parkinsons disease;and adequate compensation and incentives for health and social care workers trained in neurological disorders to work in underserved areas and to promote the retention of workers in those areas.(b)Strengthen health and social care workforce capacity to rapidly identify and address neurological disorders,including common comorbid and treatable conditions such as infectious diseases,hypoxic ischaemic perinatal brain injury,hypothyroidism,cataracts and NCDs.These initiatives should focus on the enhanced capacity of the existing workforce,both specialist and generalist,including relevant associate health professionals,as appropriate to their roles,and should include:implementing various modes of training programmes(e.g.,mental health gap action programme(mhGAP)e-learning course)for general and specialized health and social care workers to deliver evidence-based,culturally appropriate Strategic objective 2:Provide effective,timely and responsive diagnosis,treatment and care27and human rights-oriented neurological care,including by addressing stigma and discrimination for all people across the life course;developing career tracks for the neurological workforce by strengthening postgraduate training and working in partnership with medical societies to raise awareness of the appeal of working in brain health;expanding existing educational curricula and providing continuing education on the care of people with neurological disorders;expanding the role of the neurological workforce to encompass the supervision and support of general health workers in providing neurological interventions;harnessing the potential of community health workers and strengthening collaboration with other informal care providers,such as traditional healers,with effective training,support and supervision;and ensuring that people with neurological disorders are involved in the planning,development and delivery of training,as appropriate.(c)Support health and social care workers to implement and scale-up services using information and communication technologies such as telemedicine and internet/mobile phone technologies in order to expand neurological care to remote and low-resource settings and support home-based services.68.Proposed actions for Member States(continued)69.Actions for the Secretariat(a)Support Member States with adequate tools to incorporate neurological care needs into routine planning for health workers,based on the monitoring and collection of the best available data and following a health labour market approach.Planning considerations should include the identification of service gaps,neurological care training requirements and core competencies for health and social workers in the field,as well as advanced neurological care training.(b)Support Member States in building health and social care workforce capacity,including informal care providers,by promoting,strengthening and developing guidance and tools and the application of the competency-based training models required for the diagnosis,treatment and care of neurological disorders.Intersectoral global action plan on epilepsy and other neurological disorders 202220312870.Proposed actions for international and national partners(a)Facilitate the exchange of information on best practices and the dissemination of findings in health workers development and training in order to support national efforts related to the prevention,management and care of people with neurological disorders.(b)Support the implementation of capacity-building programmes,including training and education,for general and specialized health care workers to identify neurological disorders and provide evidence-based interventions to promote diagnosis,treatment and care for neurological disorders.(c)Support national authorities in the development of appropriate health care infrastructure and institutional capacity for the training of health personnel in order to strengthen health systems and expand quality services.2.4 Carer support71.Neurological disorders have a profound impact on individuals,families and communities.Due to their chronic course,people with neurological disorders often require ongoing care that is provided in large part by informal carer providers.72.Carers can be defined by their relationship to the person with a neurological condition and their care input.Many carers are relatives,but close friends or volunteers can also take on caregiving responsibilities.Carers provide“hands-on”care and support for people with neurological disorders and play a significant role in organizing lifelong care.73.Challenges for carers include stress,role strain,financial burden,social isolation and bereavement in the event of loss.Roles and challenges may vary depending on the age of the carer and are also different when caring for children,adolescents or older adults.74.Caring for a person with a neurological disorder may affect the carers own health,well-being and social relationships.The global action plan on the public health response to dementia identifies key actions to support carers that are also relevant to other neurological conditions.75.Proposed actions for Member States(a)Develop mechanisms to involve people with neurological disorders and their carers into care planning,policy-making and legal review and remove barriers to enable their participation,while paying attention to the wishes and preferences of people with neurological disorders and their families.(b)Provide accessible and evidence-based information on available resources in the community,such as training programmes,respite care,mental health services and other resources that are tailored to the needs of carers of people with neurological disorders.Strategic objective 2:Provide effective,timely and responsive diagnosis,treatment and care29(c)Within the context of community-based neurological care,provide training programmes,in collaboration with relevant stakeholders,for health and social care staff in the identification and reduction of carer stress.(d)Develop or strengthen mechanisms to protect carers,such as through the implementation of social and financial benefits(e.g.,pension,leave or flexible work hours)and policies and legislation aimed at reducing stigma and discrimination and supporting carers beyond their caregiving role.76.Actions for the Secretariat75.Proposed actions for Member States(continued)(a)Support Member States in developing and evaluating evidence-based information,data,training programmes and respite services for carers of people with neurological disorders through an intersectoral approach that is in line with the Convention on the Rights of Persons with Disabilities.(b)Facilitate access to affordable,evidence-based resources for carers of people with neurological disorders in order to improve knowledge and skills related to neurological disorders,reduce emotional stress and improve coping,self-efficacy and health,using resources such as WHOs mhGAP,iSupport,mDementia,1 the Caregivers Skills Training Programme for Children with Developmental Disorders or Delays and other education,skills training and social support resources.77.Proposed actions for international and national partners(a)Increase awareness of the impact of caring for people with neurological disorders,including the need to protect carers from discrimination,support their ability to continue to provide care throughout the disease progression and promote their self-advocacy.(b)Assist in implementing culturally sensitive,context-specific and person-centred training programmes for carers and families in order to promote well-being and enhance knowledge and caregiving skills throughout the progression of neurological disorders,starting with existing resources such as WHOs iSupport and mhGAP.Intersectoral global action plan on epilepsy and other neurological disorders 202220313031Strategic objective 3:Implement strategies for promotion and prevention78.The promotion of brain health and the prevention of neurological disorders 1involves reducing modifiable risk factors and enhancing protective factors,including during critical periods of brain development.79.Promoting optimal brain development across the life course starts with preconception,pregnancy,childhood and adolescence,is linked to healthy ageing and encourages healthy behaviour,adequate nutrition,infectious disease control,prevention of head and spinal trauma and reducing exposure to violence and environmental pollutants.80.UHC represents a key component for promoting brain health and well-being.An important element includes addressing social and economic determinants through 1 Be Healthy Be Mobile.A handbook on how to implement mDementia.Geneva:World Health Organization;2021.2 One Health.Q&A.Geneva:World Health Organization;2017(https:/www.who.int/news-room/q-a-detail/one-health,accessed 1 December 2021).a coordinated intersectoral response in a gender-sensitive manner.Collaboration with local populations,including indigenous people,should be undertaken to explore culturally appropriate ways of preventing neurological disorders that respect local customs and values.81.Incorporating a One Health2 approach for neurological disorders to design and implement programmes,policies,legislation and research,with communication between multiple sectors,public health,animal and plant health and the environment will contribute towards achieving better health outcomes by preventing neurological disorders.Intersectoral global action plan on epilepsy and other neurological disorders 2022203132Global target 3.180%of countries will have at least one functioning intersectoral programme for brain health promotion and the prevention of neurological disorders across the life course by 2031.Global targets for strategic objective 3Global target 3.2The global targets relevant for prevention of neurological disorders are achieved,as defined in:-the NCD-GAP;-Defeating meningitis by 2030:a global road map;and-Every newborn:an action plan to end preventable deaths.3.1 Promoting healthy behaviour across the life course3 Prss-stn A,Wolf J,Corvaln CF.,Bos R,Neira MP.Preventing disease through healthy environments:a global assessment of the burden of disease from environmental risks.2016;World Health Organization.4 Worldwide Project on Sleep and Health.Project Overview.Geneva:World Health Organization;2018.82.Promoting and emphasizing brain health across the life course includes focusing on healthy behaviour.There are strong interrelationships between several neurological disorders,such as dementia and stroke,with NCDs such as hypertension,diabetes,obesity and other related disorders,as well as with behavioural risk factors such as physical inactivity,unbalanced diets,tobacco use and the harmful use of alcohol.83.An understanding of the risk factors contributing to the neurological burden of disease can inform preventive measures and lead to the development of better disease-modifying strategies.84.Smoking is a behavioural risk factor associated with neurological disorders such as stroke,dementia and multiple sclerosis.Second-hand tobacco smoke was estimated to account for 4%of the global stroke burden in 2010.385.The harmful use of alcohol,such as heavy alcohol consumption,can directly affect the nervous system and result in neurological disorders such as cerebellar degeneration,neuropathy,myopathy,delirium tremens and thiamine deficiency leading to Wernicke encephalopathy or Korsakoff syndrome.It also contributes to road traffic crashes,violence,falls and associated brain and spinal cord injuries.86.Good sleep hygiene is necessary for childrens and adults overall health and well-being.Irregular sleep can be a risk factor for certain neurological disorders and people with neurological disorders often experience sleep disturbances as a consequence of their underlying disorder.433Strategic objective 3:Implement strategies for promotion and prevention87.Behavioural risk-factor modification can strengthen the capacity to make healthier choices and follow healthy behaviour patterns that foster good brain health and reduce the burden of neurological disorders.For example,exercise and regular physical activity are associated with social,mental and brain health benefits and a better quality of life,improved functioning and lower caregiver burden in people with chronic neurological disorders such as Parkinsons disease.88.Proposed actions for Member States(a)Support actions that have been shown to reduce the risk of neurological disorders across the life course by advancing strategies for healthy behaviours,such as promoting the cessation of tobacco use and excessive alcohol intake,vaccination and increasing physical activity,in line with the NCD-GAP,the global strategy to reduce the harmful use of alcohol,the WHO Guidelines on physical activity and sedentary behaviour and the WHO Guidelines on risk reduction of cognitive decline and dementia.These actions should be undertaken in collaboration with people with neurological disorders,their carers and other relevant stakeholders.(b)Develop,implement and monitor appropriately resourced,population-wide strategies that promote healthy nutrition and diet,as outlined in the WHOs comprehensive implementation plan on maternal,infant and young child nutrition,the NCD-GAP and the 2030 Agenda.(c)Encourage urban planning that improves access to sport,education,transport and physical activity in leisure/recreation in order to promote activity and provide alternatives to a sedentary lifestyle.89.Actions for the Secretariat(a)Provide technical support and strengthen global,regional and national capacities and capabilities to:raise awareness of the links between neurological disorders and other NCDs;and implement strategies for the reduction and control of modifiable risk factors for neurological disorders by developing evidence-based guidelines for cost-effective,coordinated health care interventions and integrating relevant WHO guidelines into national health planning processes and development agendas.Intersectoral global action plan on epilepsy and other neurological disorders 2022203134(b)Strengthen,share and disseminate evidence to support policy interventions for reducing potentially modifiable risk factors for neurological conditions by promoting healthy workplaces,health-promoting schools and other educational institutions,healthy cities initiatives,health-sensitive urban development and social and environmental protection.89.Actions for the Secretariat(continued)90.Proposed actions for international and national partners(a)Promote and mainstream population brain health strategies that are age-inclusive,gender-sensitive and equity-based at national,regional and international levels in order to support healthy behaviour for people with neurological disorders,their carers and families.(b)Facilitate knowledge exchange on evidence-based best practices to support actions that have been shown to reduce the risk of neurological disorders across the life course,in line with WHOs Framework Convention on Tobacco Control,the global strategy to reduce harmful use of alcohol,the global strategy on diet,physical activity and health and other relevant strategies.3.2 Infectious disease control51 United Nations Environment Programme and International Livestock Research Institute.Preventing the Next Pandemic:Zoonotic diseases and how to break the chain of transmission.Nairobi,Kenya;2017.91.The neurological consequences of infectious diseases such as meningitis,encephalitis,neurocysticercosis,malaria,HIV,toxoplasmosis,polio,enterovirus,syphilis and rabies contribute to global morbidity and mortality,especially among the most vulnerable,marginalized populations and can result in lifelong consequences(e.g.,vision and hearing loss,developmental delay,cognitive or motor impairment)that necessitate specialized follow-up care,including rehabilitation.Yet,many of these neurological consequences are preventable through immunization programmes and infectious disease control.92.The emergence of neurotropic zoonotic infections can be attributed to several causes,including unsustainable agricultural intensification and the increased use and exploitation of wildlife593.Despite advances in global infectious disease control,epidemic infections such as Zika and SARS-CoV-2 have underscored the importance of infectious disease control as a preventive measure for neurological disorders.For example,the COVID-19 pandemic is expected to impact brain health across the life course,with a wide spectrum of associated neurological manifestations in the acute and post-acute stages of illness.Strategic objective 3:Implement strategies for promotion and prevention3594.Proposed actions for Member States(a)Implement infectious disease management,eradication/elimination/control and immunization programmes based on WHO guidance,such as WHOs road map for neglected tropical diseases 20212030,the WHO guidelines on management of Taenia solium neurocysticercosis and the global road map on defeating meningitis by 2030.Include approaches for the control of other common and treatable neuroinfectious diseases such as encephalitides and their respective treatments within the health and agricultural sectors,as outlined in WHOs guidance on preventing disease through healthy environments.6(b)Support and promote the availability of rapid and affordable diagnostics for infections of the nervous system(for example lumbar puncture,microscopy,neuroimaging).(c)Collaborate with all relevant sectors and stakeholders to mitigate the risks of emerging infectious diseases that cause neurological disorders.Close coordination and intersectoral action within and beyond the health sector,including vector control,water and sanitation,animal and environmental health and education,will be needed to maximize synergies.(d)Create national operational plans to deliver interventions for neurological diseases that are in line with a One Health approach,by developing a coordinated plan that outlines stakeholder accountability for human-,animal-,food-and ecosystem-related actions and by treating animals to prevent the transmission of neuro-infectious pathogens such as mass dog vaccinations for rabies prevention.(e)Promote vaccination campaigns and sharing knowledge about the usefulness of vaccinations as a method of reducing neurological disabilities.6 Prss-stn A,Wolf J,Corvaln CF,Bos R,Neira MP.Preventing disease through healthy environments:a global assessment of the burden of disease from environmental risks.2016;World Health Organization.95.Actions for the Secretariat(a)Offer technical support,tools and guidance to Member States in order to strengthen global,regional and national awareness of infectious disease control and reduce the risk of zoonotic infections and antimicrobial and insecticide resistance,including by establishing animal or livestock trading and farming policies.(b)Highlight the neurological consequences of the COVID-19 pandemic and provide guidance on their management in order to strengthen countries response and improve service delivery at all levels of the health system.Intersectoral global action plan on epilepsy and other neurological disorders 20222031363.3 Preventing head/spinal trauma and associated disabilities7 Global,regional,and national burden of traumatic brain injury and spinal cord injury,1990-2016:a systematic analysis for the Global Burden of Disease Study 2016.Lancet Neurol.2019;18(1):5687.doi:10.1016/S1474-4422(18)30415-0.8 Prss-stn A,Wolf J,Corvaln CF,Bos R,Neira MP.Preventing disease through healthy environments:a global assessment of the burden of disease from environmental risks.2016;World Health Organization.97.Traumatic brain and spinal cord injury require complicated and costly medical care.In 2016,there were 27 million new cases of traumatic brain injury and close to 1 million new cases of spinal cord injury globally.7 Road traffic injuries and falls constitute the highest number of new cases of traumatic brain injury,while other causes such as child abuse and intimate partner violence and sports injuries are also preventable.98.Each year,37 million falls are severe enough to require medical attention and mostly affect adults aged 60 years and older,particularly those with comorbidities that impair ambulation such as dementia,Parkinsons disease or multiple sclerosis.8299.Key risk factors for road traffic injuries include speeding;alcohol or drug consumption;non-use of helmets;lack of seat belts and child restraints;inadequate visibility of pedestrians;driver distractions or fatigue;and inadequate enforcement of traffic laws.100.Many sport-related injuries can also result in traumatic brain and spinal cord injury.Repetitive mild head trauma is associated with chronic traumatic encephalopathy and increases dementia risk.Awareness,laws and policies to educate sports professionals,parents and athletes and the implementation of helmet or protective devices policies are needed to prevent some cases of traumatic brain and spinal cord injury.101.Despite the high number of head and spinal cord injuries in low-and middle-income countries,there remains a lack of services,capacity and trained specialists in neurosurgery and neurorehabilitation,which are vital in preventing long-term disability and providing follow-up care for survivors of traumatic brain and spinal cord injury.96.Proposed actions for international and national partners(a)Promote multistakeholder collaboration within and beyond the health sector,taking a One Health approach and in line with the 2030 Agenda and the SDGs.Strategic objective 3:Implement strategies for promotion and prevention37(a)Implement the recommendations included in the World report on road traffic injury prevention and proposed by the Commission for Global Road Safety.9 These cover road safety management,safer roads and mobility,safer vehicles,safer road users,increased responsiveness to post-crash emergencies and longer-term rehabilitation for victims.(b)Strengthen information systems to collect data on traumatic brain injury and spinal cord injury in order to improve understanding on the scale of the issue and its implications.(c)Promote safer contact sports and develop and implement policies and mandatory education for athletes,parents and coaches to inform them about the risks and neurological complications,such as epilepsy,that are associated with traumatic brain and spinal cord injury.(d)Develop and implement policies,standards and effective interventions to address unsafe home and community environments for older adults,including poor lighting,slippery floors,loose rugs and beds without rails,as outlined in the Global strategy and action plan on ageing and health.9 Make Roads Safe:A New Priority for Sustainable Development.Commission for Global Road Safety;2006.102.Proposed actions for Member States103.Actions for the Secretariat(a)Collect and disseminate evidence and best practices to prevent or reduce traumatic brain injury and spinal cord injury,including the prevention of road traffic crashes and falls through the implementation of the Global Plan for the Decade of Action for Road Safety.(b)Provide guidance,evidence-based practices and technical support for early rehabilitation and support to people affected by the long-term cognitive or physical consequences of traumatic brain and spinal cord injury in order to minimize both physical and psychological impacts and protect against discrimination and stigma.104.Proposed actions for international and national partnersPromote multistakeholder collaboration to raise awareness about the inherent safety and protective quality of road networks for the benefit of all road users,especially the most vulnerable(e.g.,pedestrians,bicyclists and motorcyclists)in order to prevent traumatic brain and spinal cord injury.Intersectoral global action plan on epilepsy and other neurological disorders 2022203138104.Proposed actions for international and national partners(continued)Encourage knowledge-sharing and facilitate the global,regional,intergovernmental and national strengthening of policies for safe driving,sports injuries and the promotion of national efforts for increasing helmet use in accordance with WHOs Helmets:a road safety manual for decision-makers and practitioners.3.4 Reducing environmental risks10 See GBD Compare.Viz Hub.Institute for Health Metrics and Evaluation;2021(https:/vizhub.healthdata.org/gbd-compare/,accessed 1 December 2021).11 Global elimination of lead paint:why and how countries should take action:technical brief.Geneva:World Health Organization;202012 Chemical safety.Geneva:World Health Organization(https:/www.who.int/health-topics/chemical-safety#tab=tab_1,accessed 1 December 2021).13 Ascherio A,Schwarzschild MA.The epidemiology of Parkinsons disease:risk factors and prevention.Lancet Neurol.2016;15(12):12571272.doi:10.1016/S1474-4422(16)30230-7;Ascherio A,Chen H,Weisskopf MG,OReilly E,McCullough ML,Calle EE,et al.Pesticide exposure and risk for Parkinsons disease.Ann Neurol.2006;60(2):197203.doi:10.1002/ana.20904.14 Prss-stn A,Wolf J,Corvaln CF,Bos R,Neira MP.Preventing disease through healthy environments:a global assessment of the burden of disease from environmental risks.2016;World Health Organization.15 Climate change and health.Key facts.Geneva:World Health Organization(https:/www.who.int/news-room/fact-sheets/detail/climate-change-and-health,accessed 1 December 2021).105.Exposure to environmental and occupational hazards can directly influence brain health.For example,in 2019 approximately 5%of the global stroke burden(in DALYs)was attributable to ambient air pollution10.Across the world,vulnerable communities are subject to greater exposure to environmental toxins due to the conditions in which they work and live.106.Toxin-induced encephalopathies,including exposure to heavy metals such as lead11,mercury and air pollutants(e.g.,carbon monoxide)can cause serious health and nervous system damage in all age groups.12107.Parkinsons disease has been associated with exposure to pesticides in occupational and non-occupational settings13.In addition,migraines can be triggered by environmental pollutants such as bright lights,poor air quality and noise14.108.Climate change is one of several concurrent global environmental changes that simultaneously affect human health and neurological conditions,often in an interactive manner.For example,the transmission of vector-borne neurotropic viruses such as Zika,Japanese encephalitis and West Nile disease is jointly affected by climatic conditions,population movement,deforestation,land-use patterns,biodiversity losses,freshwater surface configurations and human population density.15Strategic objective 3:Implement strategies for promotion and prevention39109.Proposed actions for Member States(a)Promote joint collaborations across relevant ministries(e.g.,environment,health,water and sanitation)to link brain health promotion and the prevention of neurological disorders with strategies that focus on healthy living,working and environmental conditions,in line with WHOs guidance on preventing disease through healthy environments.16 In particular:accelerate progress towards the global phase-out of lead paint through regulatory and legal measures;develop and implement health promotion and protection strategies and programmes across sectors in order to limit exposure to pesticides and other high-priority chemicals,such as trichloroethylene,which have been associated with neurotoxic effects;and address the health aspects of exposure to mercury and mercury compounds through collaboration between health authorities,environment authorities and others.(b)In partnership with nongovernmental organizations,the private sector and other intersectoral stakeholders,integrate environmental determinants that are specific to brain health and neurological disorders into broader mitigation strategies for reducing the impact of climate change,including interventions and policies that promote access to clean air(ambient and household),such as the reduction of fossil fuels and the promotion of cleaner cookstoves and safe water,sanitation,and hygiene.16 Prss-stn A,Wolf J,Corvaln CF,Bos R,Neira MP.Preventing disease through healthy environments:a global assessment of the burden of disease from environmental risks.2016;World Health Organization.110.Actions for the Secretariat(a)Provide support to Member States in evaluating and implementing evidence-based options that suit their needs and capacities in order to assess the health impact of public policies,evidence generation and guidance regarding environmental risk such as air pollution,heavy metals,pesticide and industrial solvents for optimal brain health and the prevention of neurological disorders.111.Proposed actions for international and national partners(a)Promote at national,regional and international levels WHOs guidance on preventing disease through healthy environments and highlight the importance of climate change on brain health,in line with the 2030 Agenda and the SDGs.(b)Collaborate with stakeholders to support the development of international standards for environmental pollutants(e.g.,Intersectoral global action plan on epilepsy and other neurological disorders 2022203140111.Proposed actions for international and national partners(continued)emissions,second-hand smoke and levels of environmental toxins)to help guide legislation.(c)Support research to understand the contribution of environmental risk factors to the morbidity and mortality of neurological disorders,especially in low-resource settings.3.5 Promotion of optimal brain development in children and adolescents17 Nurturing care for early childhood development:a framework for helping children survive and thrive to transform health and human potential.Geneva:World Health Organization;2018.18 Prss-stn A,Wolf J,Corvaln CF,Bos R,Neira MP.Preventing disease through healthy environments:a global assessment of the burden of disease from environmental risks.2016;World Health Organization.112.The early stages of life,including the fetal stage and birth,present a particularly important opportunity to promote brain health and prevent neurological disorders that can have lifelong consequences as a childs brain develops and adapts rapidly in response to the surrounding environment,nutrition and stimulation.113.Optimizing brain development in the formative stages involves creating conditions for nurturing care17 and family and parenting support through public policies,programmes and services.These enable communities and caregivers to attend to childrens good health,nutrition and protection from threats.114.Access to formal education and inclusive education for children with disabilities have also been shown to improve brain health outcomes.All children and adolescents should be able to live,study and socialize in supportive,healthy and safe environments without stigma,discrimination or bullying.Exposure to early life adversity such as maltreatment,neglect,experience of war or conflict,inadequate maternal nutrition(such as lack of folic acid or iron),poor caregiver health,substance use,congenital infections(such as TORCH syndrome toxoplasmosis,rubella,cytomegalovirus,herpes simplex)or birth complications can have a negative impact on the developing brain and carry lifelong implications for brain health.115.Certain environmental pollutants are specifically known to affect neurodevelopment.These include air pollution,heavy metals in soil and water,lead in household paint,mercury in seafood and workplace exposure and pesticides.18 Young children are especially vulnerable to lead toxicity and even low levels of exposure can result in reduced attention span,behavioural problems and reduced educational attainment.116.Physical activity can confer health benefits for children and adolescents living with neurological conditions,hence limiting sedentary behaviour such as screen-based entertainment(television and computers)and digital communications such as mobile phones is recommended.In addition,adequate sleep regimens maximize health benefits and brain development for children and adolescents.Strategic objective 3:Implement strategies for promotion and prevention41117.Proposed actions for Member States(a)Develop,fund and implement strategies to promote healthy brain development and prevent neurological disorders in childhood and adolescence,focusing on early intervention and rehabilitation.(b)Optimize perinatal and child health care,including safe labour and delivery to prevent hypoxic ischaemic brain damage,neonatal intensive care,the use of birth attendants,skin to skin contact(kangaroo mother care),breastfeeding,maternal mental health care,adequate nutrition,immunization,and child development interventions for responsive caregiving and early learning in line with the WHO nurturing care framework.Encourage and strengthen neurodevelopmental assessment in children and adolescents for early diagnosis and intervention.(c)In partnership with relevant national regulatory authorities and other stakeholders,develop,strengthen and monitor breastfeeding and national food and nutrition policies and action plans in line with the global strategy for infant and young child feeding,the comprehensive implementation plan on maternal,infant and young child nutrition and WHOs set of recommendations on the marketing of foods and non-alcoholic beverages to children.19(d)Accelerate the full implementation of the WHO Framework Convention on Tobacco Control in order to reduce fetal exposure,childhood second-hand smoke exposure and adolescent smoking.(e)Develop and implement,as appropriate,comprehensive and intersectoral national policies and programmes to reduce the harmful use of alcohol during pregnancy so as to reduce complications such as fetal alcohol spectrum disorder.(f)Promote adolescent access to the recommended interventions in the Global Strategy for Womens,Childrens and Adolescents Health,including in humanitarian and fragile settings.Support interventions to promote adolescent brain health and development and establish,as appropriate,adolescent-friendly spaces as a first response to adolescent needs for protection,psychosocial well-being and nonformal education.(g)Develop appropriately resourced policies for the improved provision of quality physical education in educational settings,including opportunities for physical activity before,during and after the formal school day.Parks,trees and green areas within urban centres can improve local air quality and offer a refuge for children to play.Implement WHO Guidelines on physical activity 19 Guidance on ending the inappropriate promotion of foods for infants and young children:implementation manual.Geneva:World Health Organization;2017.Intersectoral global action plan on epilepsy and other neurological disorders 2022203142and sedentary behaviour,including the recommendations on recreational screen time.(h)Strengthen surveillance mechanisms for the core indicators of brain health and development in children and adolescents,including protective and risk factors.117.Proposed actions for Member States(continued)118.Actions for the Secretariat(a)Offer technical support,tools and guidance to Member States and strengthen national capacity for the promotion of optimal brain development in children and adolescents by:enhancing leadership within health ministries and other sectors for the development,strengthening and implementation of evidence-based national and/or subnational strategies and associated intersectoral resource planning to optimize brain development in children and adolescents;and compiling and sharing knowledge and best practices related to existing policies that address early childhood and adolescent development,including codes of practice and mechanisms to monitor the protection of human rights.119.Proposed actions for international and national partners(a)Support the development and implementation of global,regional,national and/or subnational policies and programmes for children and adolescents to address maltreatment,neglect,inadequate maternal nutrition,poor caregiver health,substance use(such as alcohol and smoking),congenital infections,birth complications and environmental pollutants.Strategic objective 3:Implement strategies for promotion and prevention43Strategic objective 4:Foster research and innovation and strengthen information systems120.Evidence generation through high-quality research is needed to inform policy,planning and programming for neurological disorders.It can provide insight into effective services,care models and treatment options,and foster innovation and equitable access to products such as health technology for prevention,risk reduction,early diagnosis,treatment and the potential for cure or care for neurological disorders.121.The complexity surrounding brain and neurological research requires improved coordination in the research environment,with multistakeholder involvement and publicprivate partnerships and allocation of sufficient resources.In this context,cultivating an environment that fosters research collaborations,including data-sharing,is vital to reduce duplication,identify knowledge gaps,fast-track innovation and build capacity in low-income settings.122.Implementation research,including health systems evaluation,should be prioritized to harness and scale prevention and treatment strategies for neurological disorders.Such an approach will facilitate the monitoring of interventions and allow for the replication and adaptation of successful interventions.123.Better representation of low-and middle-income countries in the neuroscience research environment should also acknowledge country-specific and local needs so that strategies for diagnosis and management of neurological disorders are tailored to the context.124.The meaningful engagement of people with neurological disorders,their carers and families to better support and guide the research and development of innovative solutions for neurological disorders is a principal component of the research agenda.125.Robust,standardized and easily accessible data forms the basis for effective planning and the establishment of targeted interventions.Yet significant data gaps on neurological disorders exist not only in low-and middle-income countries but also in high-income countries.Intersectoral global action plan on epilepsy and other neurological disorders 2022203144Global target 4.180%of countries routinely collect and report on a core set of indicators for neurological disorders through their national health data and information systems at least every three years by 2031.Global targets for strategic objective 4 Global target 4.2The output of global research on neurological disorders doubles by 2031.4.1 Investment in research126.If the incidence of neurological disorders is to be reduced and the lives of people with neurological disorders are to be improved,sustained investment in biomedical,clinical,implementation and translational research is crucial to inform prevention,diagnosis,treatment and care and create the potential to cure more neurological disorders.127.All research and innovation activities for neurological disorders must be rooted in equity,diversity and inclusiveness,with increased engagement of people with neurological disorders.128.Investments in neurological research should be accompanied by increased collaboration between Member States and relevant stakeholders,with a particular focus on strengthening global and regional cooperation.Facilitating a global research agenda for neurology will increase the likelihood of effective progress towards better prevention,diagnosis,treatment and care for people with neurological disorders,while reducing redundancies and the duplication of research and costs.129.Concerted action to build research infrastructure,strengthen human resources in research and development and increase collaboration among the research community,health professionals,people with neurological
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Global strategy and action plan on oral health20232030Global strategy and action plan on oral health20232030Global strategy and action plan on oral health 20232030ISBN 978-92-4-009053-8(electronic version)ISBN 978-92-4-009054-5(print version)World Health Organization 2024Some rights reserved.This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence(CC BY-NC-SA 3.0 IGO;https:/creativecommons.org/licenses/by-nc-sa/3.0/igo).Under the terms of this licence,you may copy,redistribute and adapt the work for non-commercial purposes,pro-vided the work is appropriately cited,as indicated below.In any use of this work,there should be no suggestion that WHO endorses any specific organization,products or services.The use of the WHO logo is not permitted.If you adapt the work,then you must license your work under the same or equivalent Creative Commons licence.If you create a translation of this work,you should add the following disclaimer along with the 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by initial capital letters.All reasonable precautions have been taken by WHO to verify the information contained in this publication.How-ever,the published material is being distributed without warranty of any kind,either expressed or implied.The responsibility for the interpretation and use of the material lies with the reader.In no event shall WHO be liable for damages arising from its use.ContentsForeword vAcknowledgements viPurpose viiGlobal oral health action plan(2023-2030)1Background 2Scope,aim and overarching targets of the global oral health action plan(20232030)5Action areas of the global oral health action plan 6 Action area for strategic objective 1:oral health governance 7Proposed actions for member states 8Actions for the WHO secretariat 10Proposed actions for international partners 11Proposed actions for civil society organizations 12Proposed actions for the private sector 12 Action area for strategic objective 2:oral health promotion and oral disease prevention 13Proposed actions for member states 14Actions for the WHO secretariat 17Proposed actions for international partners 17Proposed actions for civil society organizations 18Proposed actions for the private sector 18 Action area for strategic objective 3:health workforce 21Proposed actions for member states 22Actions for the WHO secretariat 24Proposed actions for international partners 24Proposed actions for civil society organizations 25Proposed actions for the private sector 25 Action area for strategic objective 4:oral health care 27Proposed actions for member states 28Actions for the WHO secretariat 31Proposed actions for international partners 31Proposed actions for civil society organizations 31Proposed actions for the private sector 32 Action area for strategic objective 5:oral health information systems 33Proposed actions for member states 34Actions for the WHO secretariat 35Proposed actions for international partners 36Proposed actions for civil society organizations 36Proposed actions for the private sector 36 Action area for strategic objective 6:oral health research agendas 37Proposed actions for member states 38Actions for the WHO secretariat 39Proposed actions for international partners 39Proposed actions for civil society organizations 39Proposed actions for the private sector 40Monitoring implementation progress of the global oral health action plan 41Appendix 1 43Monitoring framework of the global oral health action plan 44Core indicators 48Appendix 2 61Complementary indicators 62Annex 1:Global strategy on oral health WHA75(11)73Annex 2:Resolution on oral health WHA74.5 85vForewordOral diseases are among the most common noncommunicable diseases worldwide,affecting an estimated 3.5 billion people.The burden is increasing,particularly in low-and middle-income countries.Good oral health is essential for eating,breathing and speaking,and contributes to overall health.The pain and discomfort associated with oral diseases make concentrating difficult,can cause people to miss school or work,and can lead to social isolation.Left untreated,the health-related impact of oral diseases can be severe.Unfortunately,access to oral health care is often limited due to an over-reliance on specialised care using high-tech equipment,the cost of which is prohibitive for many families and communities.In fact,many oral diseases are largely preventable and can be treated using simple and non-invasive procedures at the primary health care level.Improving access and affordability to essential oral health care services can be achieved through integrating oral health promotion and care into primary health care and universal health coverage benefit packages.Member States have demonstrated their commitment to improving oral health in recent years by adopting the landmark Resolution on oral health in 2021 and the Global strategy on oral health in 2022.This was followed in 2023 by the development of the Global oral health action plan 20232030,which translates the vision,goal and strategic objectives of the global strategy into a series of 100 actions for stronger and more coordinated action on oral health.The action plan also includes a set of 11 global targets to track progress on oral health for all individuals and communities by 2030.The Global strategy and action plan on oral health 2023-2030 contains the complete set of policy documents that define WHOs global oral health agenda.Together,these policy documents lay out the path to tackle the challenges faced by communities worldwide,and make the case for integrating oral health into noncommunicable disease and universal health coverage benefit packages.The action plan is a practical tool to support Member States in the adaptation of global oral health policies to national contexts.It outlines a set of priority actions for Member States,the WHO Secretariat,international partners,civil society organisations and the private sector in moving towards our shared commitment to equitable access to oral health for all.WHO supports Member States in the implementation of these policies,within their own national context.Together,we can reverse the pattern of neglect in oral health,and improve coverage and access around the world,and make sure that everybody gets the care they need for preventable and treatable oral diseases.There is no health without oral health.Dr Tedros Adhanom Ghebreyesus Director-General World Health OrganizationviGlobal strategy and action plan on oral health 20232030 AcknowledgementsWHO is grateful for the contributions and collaboration with Member States especially the Member States that supported the Resolution on oral health in 2021(WHA 74.5)led by Sri Lanka,along with oth-er co-sponsoring countries including Bangladesh,Bhutan,Botswana,Eswatini,India,Indonesia,Israel,Japan,Jamaica,Kenya,Myanmar,Peru,Qatar,Thailand and the Member States of the European Un-ion.The resolution provided a mandate to the WHO Secretariat to develop the Global strategy on oral health,adopted in May 2022(decision WHA75(11),and the Global oral health action plan 20232030 in the report on noncommunicable diseases NCDs,noted by the Seventy-sixth World Health Assembly(WHA 76(9).WHO extends sincere gratitude to the many individuals,organizations,and professional bodies who contributed to the development of the Global strategy on oral health and Global oral health action plan 2023-2030.These global oral health policy documents are the result of a highly consultative and participatory process involving Member States,international and national non-governmental organi-zations,related global health networks,partners,stakeholders,and the entire oral health community and beyond.WHO is extremely grateful to all for their valuable feedback and contributions received throughout the development process,including the regional consultations.Particularly,WHO would like to thank all Members States,UN organizations,and non-State actors that participated in a global web-based consultation.Appreciation also goes to McGill University,Canada,and the International Health Policy Programme,Foundation of the Ministry of Public Health in Thai-land.Additionally,WHO appreciates the efforts of the informal expert group and WHO Collaborating Centres on oral health who were part of the development of the global oral health monitoring frame-work of the Global oral health action plan 2023-2030.Finally,WHO acknowledges the WHO staff and consultants of WHO headquarters and WHO Regional Office for Africa,WHO Regional Office for the Americas,WHO Regional Office for South-East Asia,WHO Regional Office for Europe,WHO Regional Office for the Eastern Mediterranean,and WHO Regional Office for the Western Pacific,who have valuably contributed to producing these global oral health policy documents.WHO acknowledges with gratitude the funds received from the WHO voluntary contributions of the Borrow Foundation towards the development and publication of these global oral health policy docu-ments.viiPurposeThis document incorporates all key policy documents that inform and define the renewed global oral health agenda towards 2030:the Resolution on oral health(WHA74.5,2021)1 the Global strategy on oral health(WHA75(11),2022)2 the Global oral health action plan 20232030(WHA76(9),2023)3.Underlying the global oral health agenda are six guiding principles presented in detail in the Global strategy on oral health.These principles underpin the approach taken to develop the strategy and the Global oral health action plan 20232030 and can be applied when implementing the agenda in Member States.They are:a public health approach to oral health integration of oral health into primary health care innovative workforce models to respond to population needs for oral health people-centred oral health care tailored oral health interventions across the life course optimizing digital technologies for oral health.The action plan provides detailed action-oriented guidance for different stakeholder groups.As such,it is the focus of this document,as it translates how to achieve the ambition set out in the strategy and the mandate of the Resolution on oral health.Combined,these policy documents set the global oral health agenda towards 2030.The global oral health agenda paves the way towards improved accessibility and affordability of oral health care,in line with UHC,and serves to support cooperation among countries and different sectors.Countries are invited to consider the strategic objectives and actions as a source of ideas and concrete guidance as part of their national oral health policy development.The concepts presented here for implementation have huge potential to reorient oral health care to a patient-centred model as part of a primary health care approach.In doing so,countries will further contribute to their UHC ambition and add value to their efforts in tackling NCDs.Resolution on oral health:pioneering a new perspective The World Health Assembly Resolution on oral health(WHA74.5)was a clear milestone in establishing a renewed global oral health policy agenda.It recognized the urgent need for a paradigm shift from the traditional curative approach towards a preventive approach,with improved integration of oral health services within more mainstream health system structures.1 Resolution WHA74.5.Oral health.In:Seventy-fourth World Health Assembly,Geneva,24 May1 June 2021.Resolutions and decisions,annexes.Geneva:World Health Organization;2021(WHA74/2021/REC/1;https:/apps.who.int/gb/ebwha/pdf_files/WHA74-REC1/A74_REC1-en.pdf#page=1).2 A75/10 Add.1.Draft global strategy on oral health.In:Seventy-fifth World Health Assembly,Geneva,2228 May 2022.Provisional agenda item 14.1.Geneva:World Health Organization;2022(https:/apps.who.int/gb/ebwha/pdf_files/WHA75/A75_10Add1-en.pdf).3 Draft global oral health action plan(20232030).Geneva:World Health Organization;2023(https:/cdn.who.int/media/docs/default-source/ncds/mnd/oral-health/eb152-draft-global-oral-health-action-plan-2023-2030-en.pdf?sfvrsn=2f348123_19&download=true).viiiGlobal strategy and action plan on oral health 20232030 By endorsing this resolution,Member States signaled their commitment to prioritize oral health as an integral part of the global health agenda in the context of NCD and UHC agendas,elevating it to the global forefront.Global strategy on oral health As a first step to implementing the mandate given to the WHO Secretariat through the resolution,WHO developed the Global strategy on oral health(WHA75(11).The vision of the global strategy is UHC for oral health for all individuals and communities by 2030,thereby aligning it with the ambition of the Sustainable Development Goals.This vision means that all individuals and communities have access to essential,quality health services that respond to their needs and that they can use without suffering financial hardship.The strategy was developed through an extensive consultation process that included Member States,other United Nations organizations and non-State actors.The strategy outlines six strategic objectives:1.Oral health governance 2.Oral health promotion and oral disease prevention 3.Health workforce 4.Oral health care 5.Oral health information systems 6.Oral health research agendas.Additionally,the strategy introduces the respective roles of the WHO Secretariat,Member States and other partners emphasizing a collective responsibility to take action and the importance of collaboration within and outside of the oral health community.Coordination among efforts to bridge gaps,tackle NCDs using a common risk factor approach and progressing the UHC agenda through improved affordability and accessibility to oral health services will enable individuals and communities to enjoy the highest attainable state of oral health,contributing to healthy and productive lives.Global oral health action plan:translating vision into action Guided by the Global strategy on oral health,the Global oral health action plan 2023-2030 translates the vision,goal and strategic objectives into action-oriented guidance on interventions for stronger and more coordinated action on oral health.It is the main practical tool for adaptation of the global oral health policy agenda to national contexts.It is structured according to 11 global targets,6 strategic objectives and 100 actions for Member States,WHO secretariat,international partners,civil society organisation and the private sector.The proposed actions can be adapted and prioritized depending on individual country context,taking into consideration available resources,population needs and social,economic and political factors.MethodsThe Global strategy on oral health was developed through a series of consultative processes,which included a global web-based consultation with Member States,UN organizations,and non-State ixactors from August to September 2021.Furthermore,WHO conducted the Member States information sessions and technical consultation with UN organizations,and non-State actors in official relations with WHO.Similarly,the development of the Global oral health action plan 2023-2030 involved a series of consultative processes.Specifically,WHO conducted a Delphi process,engaging a global informal expert group that included WHO Collaborating Centres on oral health to inform the global oral health monitoring framework.Subsequently,informal regional consultations took place between May and July 2022.This was followed by a global web-based consultation with Member States,UN organizations,and non-State actors between August and September 2022.Furthermore,WHO organized Member States information session and technical consultation with UN organizations,and non-State actors in official relations with WHO.As we move forward with this ambitious global oral health agenda towards 2030,this document will serve as the basis for collective action and country support.By embracing the vision,goal and strategic objectives,we all have a role to play in uniting around a shared commitment to equitable access to oral health for all.Global oral healthaction plan(2023-2030)World health assemblyWHA76(9)Background Scope,aim and overarching targets of the global oral health action plan(20232030)Action areas of the global oral health action plan 2Global strategy and action plan on oral health 20232030 BackgroundSetting the scene 1.In the Political Declaration of the High-Level Meeting of the General Assembly on the Prevention and Control of Noncommunicable Diseases(2011),the United Nations General Assembly recog-nized that oral diseases are major global health burdens and share common risk factors with other noncommunicable diseases(NCDs).In the Political Declaration of the High-Level Meeting on Uni-versal Health Coverage(2019),the General Assembly reaffirmed its strong commitment to the pre-vention and control of NCDs,including strengthening and scaling up efforts to address oral health as part of universal health coverage(UHC).2.Oral health is the state of the mouth,teeth and orofacial structures that enables individuals to per-form essential functions,such as eating,breathing and speaking,and encompasses psychosocial dimensions,such as self-confidence,well-being and the ability to socialize and work without pain,discomfort and embarrassment.Oral health varies over the life course from early life to old age,is integral to general health and supports individuals in participating in society and achieving their potential.3.Oral health encompasses a range of diseases and conditions.Those with highest public health rel-evance include dental caries,severe periodontal(gum)disease,complete tooth loss(edentulism),oral cancer,oro-dental trauma,noma and congenital malformations such as cleft lip and palate,most of which are preventable.The main oral diseases and conditions are estimated to affect close to 3.5 billion people worldwide.1 These conditions combined have an estimated global prevalence of 45%,which is higher than the prevalence of any other NCD1.4.The global burden of oral diseases and conditions is an urgent public health challenge with so-cial,economic and environmental impacts.2 Oral diseases and conditions disproportionately affect poor,vulnerable and/or marginalized members of societies,often including people who are on low incomes;people living with disability;older people living alone or in care homes;people who are refugees,in prison or living in remote and rural communities;and people from minority and/or other socially marginalized groups.There is a strong and consistent association between socioec-onomic status and the prevalence and severity of oral diseases and conditions.1 Public and private expenditures for oral health care have reached an estimated 387 billion US dollars globally,with very unequal distribution across regions and countries.15.Oral diseases and conditions share risk factors common to the leading NCDs,including all forms of tobacco use,harmful alcohol use,high intake of free sugars and lack of exclusive breastfeeding.Other risk factors include insufficient oral hygiene for dental caries and severe periodontal diseas-es;human papillomavirus for oropharyngeal cancers;traffic accidents,interpersonal violence and sports injuries for traumatic dental injuries;and coinfections,malnutrition and poor water,sanita-tion and hygiene for noma.6.Oral diseases and conditions are influenced by social determinants of oral health,which comprise the social,economic and political conditions that influence oral diseases,including access to safe 1 Global oral health status report:towards universal health coverage for oral health by 2030.Geneva:World Health Organization;2022.Licence:CC BY-NC-SA 3.0 IGO.2 Seventy-fifth World Health Assembly,Provisional agenda item 14.1,27 April 2022,https:/apps.who.int/gb/ebwha/pdf_files/WHA75/A75_10Add1-en.pdf.Global oral health action plan(2023-2030)3water,sanitation and hygiene.They are also affected by commercial determinants,which are the strategies used by some private-sector actors to promote products and choices that are detrimental to health.This includes marketing,advertising and sale of products that cause oral diseases and conditions,such as tobacco products and food and beverages that are high in free sugars.7.Essential oral health care covers a defined set of safe,cost-effective interventions at individual and community levels that promote oral health and prevent and treat the most prevalent and/or severe oral diseases and conditions,including appropriate rehabilitative services and referral.8.Availability and coverage of oral health care are highly variable within and between countries.As a result,millions of people still do not have access to and financial coverage for essential oral health care,leading to high out-of-pocket payments for patients.3 The COVID-19 pandemic has significant-ly affected oral health services and worsened inequalities for disadvantaged population groups,highlighting the need for continued essential oral health services in emergency situations.9.Environmental challenges related to oral health care include the efficient use of natural resources,such as water and energy;the use of safe and environmentally sound oral health supplies and con-sumables and oral care products;sustainable waste management;reduction of carbon emissions;and the need to accelerate the phase down in use of mercury-containing dental amalgam.10.Most oral diseases and conditions are preventable and can be effectively addressed through pop-ulation-based public health measures.Upstream policy interventions,such as those targeting social and commercial determinants,are cost-effective with high population reach and impact.Midstream initiatives include creating more supportive conditions in key settings like households,schools,workplaces,long-term care facilities and community venues.Downstream interventions are also critical,including essential prevention and evidence-based clinical oral health care.The 2021 resolution on oral health and its mandate11.Recognizing the global public health importance of major oral diseases and conditions,the World Health Assembly adopted a resolution on oral health(WHA74.5)in May 2021,requesting that oral health be embedded within the NCD and UHC agendas.12.In the resolution on oral health,Member States also requested the Director-General to develop a draft global strategy on tackling oral diseases,in consultation with Member States,by 2022;to translate this global strategy,by 2023,into an action plan for public oral health,including a frame-work for tracking progress with clear measurable targets to be achieved by 2030;to develop techni-cal guidance on environmentally friendly and less invasive dentistry to support countries with their implementation of the Minamata Convention on Mercury;to continue to update technical guidance to ensure safe and uninterrupted dental services,including under circumstances of health emer-gencies;to develop“best buy”interventions on oral health by 2024,as part of the updated Appen-dix 3 of the Global Action Plan of NCDs 2013-2030 and integrated into the WHO UHC Compendium of health interventions;to include noma in the planned WHO 2023 review process to consider the classification of additional diseases within the road map for neglected tropical diseases 20212030;and to report back on progress and results until 2031 as part of the consolidated report on NCDs.3 Petersen PE,Baez RJ,Ogawa H.Global application of oral disease prevention and health promotion as measured 10 years after the 2007 World Health Assembly statement on oral health.Community Dent Oral Epidemiol.2020;48:338348.doi:10.1111/cdoe.12538.4Global strategy and action plan on oral health 20232030 13.The resolution on oral health is aligned with and builds on other relevant global commitments,in-cluding the 2030 Agenda for Sustainable Development,particularly Sustainable Development Goal 3(Ensure healthy lives and promote well-being for all at all ages)and its target 3.8 on achieving UHC,as well as Pillars 1 and 3 of WHOs Thirteenth General Programme of Work,20192023.The global strategy on oral health14.As a first step in the implementation of the resolution on oral health,Member States adopted the Global Strategy on Oral Health in May 2022 at the Seventy-fifth World Health Assembly(A75/10 Add.1 and WHA75(11).The strategy is aligned to the Operational Framework for Primary Health Care(2020);the Global Competency and Outcomes Framework for Universal Health Coverage(2022);the Global Strategy on Human Resources for Health:Workforce 2030(2016);the Global Ac-tion Plan for the Prevention and Control of NCDs 20132020;the WHO Framework Convention on Tobacco Control adopted in 2003;resolution WHA74.16(2021)on social determinants of health;decision WHA73(12)(2020)on the United Nations Decade of Healthy Ageing 20212030;and reso-lution WHA67.11(2014)on public health impacts of exposure to mercury and mercury compounds:the role of WHO and ministries of public health in the implementation of the Minamata Convention.15.The vision of the Global Strategy on Oral Health is UHC for oral health for all individuals and com-munities by 2030,enabling them to enjoy the highest attainable state of oral health and contribut-ing to healthy and active lives.Universal health coverage means that all individuals and commu-nities have access to essential,quality health services that respond to their needs and that they can use without suffering financial hardship.These services should include oral health promotion and prevention as well as treatment and rehabilitation interventions related to oral diseases and conditions across the life course.Achieving the highest attainable standard of oral health is a fun-damental right of every human being.16.The goal of the Global Strategy on Oral Health is to guide Member States to:(a)develop ambitious national responses to promote oral health;(b)reduce oral diseases,other oral conditions and oral health inequalities;(c)strengthen efforts to address oral diseases and conditions as part of UHC;and(d)consider the development of national and subnational targets and indicators,in order to prioritize efforts and assess progress made by 2030.17.The six guiding principles of the Global Strategy on Oral Health are:a public health approach to oral health integration of oral health into primary health care innovative workforce models to respond to population needs for oral health people-centred oral health care tailored oral health interventions across the life course optimizing digital technologies for oral health.18.The six strategic objectives of the Global Strategy on Oral Health are:Strategic objective 1:Oral health governance Improve political and resource commitment to oral health,strengthen leadership and create winwin partnerships within and outside the health sector.Strategic objective 2:Oral health promotion and oral disease prevention Enable all people to achieve the best possible oral health and address the social and commercial determinants and risk factors of oral diseases and conditions.Strategic objective 3:Health workforce-Develop innovative workforce models and revise and Global oral health action plan(2023-2030)5expand competency-based education to respond to population oral health needs.Strategic objective 4:Oral health care Integrate essential oral health care and ensure related financial protection and essential supplies in primary health care.Strategic objective 5:Oral health information systems Enhance surveillance and health in-formation systems to provide timely and relevant feedback on oral health to decision-makers for evidence-based policy-making.Strategic objective 6:Oral health research agendas Create and continuously update context-and needs-specific research that is focused on the public health aspects of oral health.Scope,aim and overarching targets of the global oral health action plan(20232030)19.The Global Oral Health Action Plan(20232030)is a critical step in the implementation of both the resolution on oral health and the Global Strategy on Oral Health.It is grounded in the strategys vision,goal,guiding principles,strategic objectives and the roles it outlines for Member States,the WHO Secretariat,international partners,civil society and the private sector.20.The aim of the Global Oral Health Action Plan is to translate the six strategic objectives of the Global Strategy on Oral Health into a set of evidence-informed actions that can be adapted to national and sub-national contexts,including proposed actions for Member States,the WHO Secretariat,inter-national partners,civil society organizations and the private sector.The proposed actions for Mem-ber States should be adapted and prioritized depending on national circumstances,taking into consideration available resources,population needs and social,economic and political contexts.21.The monitoring framework of the Global Oral Health Action Plan provides two overarching global targets and nine global targets related to the strategic objectives,including a set of core indicators to assess implementation progress.Information on the core indicators(Appendix 1)will be report-ed regularly by WHO,using data provided by Member States.A set of complementary indicators(Appendix 2)is also proposed as part of the monitoring framework.Member States are encouraged to use the complementary indicators to monitor other oral health data at the national level for evi-dence-informed policy development and decision-making.22.The Global Oral Health Action Plan has two overarching global targets to be achieved by 2030:By 2030,80%of the global population is entitled to essential oral health care services.Overarching global target A:Oral health services are part of UHCOVERARCHING GLOBAL TARGETSBy 2030,the combined global prevalence of the main oral diseases and conditions over the life course shows a relative reduction of 10%.Overarching global target B:Reduced oral disease burden-1080%6Global strategy and action plan on oral health 20232030 Action areas of the global oral health action plan 23.The action areas of the Global Oral Health Action Plan are aligned with the six strategic objectives of the Global Strategy on Oral Health.Generally,a public health and population-level approach should be taken when implementing these actions,including consideration of equity for poor,vul-nerable and/or marginalized members of societies.Proposed actions for member states Actions for the WHO secretariat Proposed actions for international partners Proposed actions for civil society organizations Proposed actions for the private sectorAction area forstrategic objective 1:oral health governance8Global strategy and action plan on oral health 20232030 Action area for strategic objective 1:oral health governance24.Strategic objective 1 aims to improve political and resource commitments to oral health,strengthen leadership and create winwin partnerships within and outside of the health sector.This objective seeks the recognition and integration of oral health in all relevant policies and public health pro-grammes as part of the broader national NCD and UHC agendas.Increased political and resource commitment to oral health is vital at the national and subnational levels,as is reform of health and education systems.Central to this process is establishing or strengthening the capacity of a nation-al oral health unit with professionals trained in public health.A dedicated,qualified,functional,well-resourced and accountable oral health unit should be established or reinforced within NCD structures and other relevant public health and education services.25.Sustainable partnerships within and outside of the health sector,as well as engagement with com-munities,civil society and the private sector,are essential to mobilize resources,target the social and commercial determinants of oral health and implement reforms.Proposed actions for member statesAction 1.Develop and implement a national oral health policy,strategy or action plan:Develop a new national oral health policy or review the existing policy to ensure its alignment with the Global Strategy on Oral Health and its integration with na-tional NCD and UHC policies.Ensure the policy promotes oral health equity and prioritizes public health.Confirm that the policy coordinates oral health efforts and management across relevant national agencies and subnational levels,in-cluding safe and uninterrupted oral health services during health emergencies.Prepare national implementation guidance,including a monitoring framework aligned with the monitoring framework of the Global Oral Health Action Plan.A periodic review of the policy should be undertaken within five years of its onset.1GLOBAL TARGETS FOR STRATEGIC OBJECTIVE 1By 2030,90%of countries have implemented measures to phase down the use of dental amalgam as stipulated in the Minamata Convention on Mercury or have phased it out.Global target 1.1:National leadership for oral healthGlobal target 1.2:Environmentally sound oral health care90%By 2030,80%of countries have an operational national oral health policy,strategy or action plan and dedicated staff for oral health at the Ministry of Health or other national governmental health agency.Action area for strategic objective 1:oral health governance 9Action 2.Strengthen national oral health leadership:Institute or reinforce an oral health unit at the Ministry of Health or another appropriate national governmental health agency to oversee national policy,technical,surveillance,management,coordination and advocacy functions.Appoint an officer to lead the oral health unit.Consider,as appropriate for the national context,active integration and/or coordination mechanisms between the oral health unit and the NCD depart-ment or other technical programmes.Support capacities of oral health unit staff by assessing training needs and providing training and coaching opportunities,including management,leadership and public health skills,as appropriate.Em-power national regulatory agencies to ensure ethical standards of professional conduct and quality oral health care.Action 3.Create and sustain dedicated oral health budgets:Explore,as appropriate for national context,establishing dedicated oral health budgets at national and subnational levels covering policy,public service staff,programme and supply costs.Examine sustainable domestic sources of financial support,such as taxa-tion policies.Consider directing public health expenditure towards oral health promotion,prevention and care as a distinct budget and a first step towards es-tablishing a guaranteed minimum share of public health expenditure dedicated exclusively to oral health.Action 4.Integrate oral health into broader policies:Advocate for UHC as a means of improving prevention and control of oral diseases and conditions for the whole population.Facilitate and operationalize the inclusion of oral health in all related national policies,strategies and programmes,particularly in the context of NCDs,primary health care,health equity and UHC.Include sectors beyond health,such as education,development,environment,water,sanitation and hygiene,finance,telecommunications or social protection.Action 5.Forge strategic partnerships for oral health:Explore the potential for strategic partnerships to implement policies,mobilize resources,target social and com-mercial determinants and accelerate required reforms.Engage policy-makers,researchers,oral health professionals and the general public at the earliest stag-es of policy and research development to ensure they have the greatest positive impact on national oral health and beyond.Develop and enforce policies on en-gagement with partners to eliminate conflicts of interest and undue influence.Initiate or strengthen ministerial coordination and oversight mechanisms relat-ed to partnerships,including public-private partnerships.Collaborate with in-ternational and development partners to support implementation of oral health policies in national health plans.Action 6.Engage with civil society about oral health:Ensure participation of civil society organizations and patient support groups and empowerment of the community in planning,implementing and monitoring appropriate programmes.Provide platforms for engagement and actively seek representation from poor,vulnera-ble and/or marginalized members of societies.Involve national oral health,med-ical and public health associations and community-based organizations in oral health policy and guideline development as well as implementation and integra-tion of oral health in wider health care and social services.10Global strategy and action plan on oral health 20232030 Action 7.Phase down the use of dental amalgam:Ratify the Minamata Convention on Mercury and support related national assessments and implementation plans.Accelerate implementation of measures to phase down the use of dental amal-gam in accordance with existing and future decisions of the Conference of the Parties to the Minamata Convention on Mercury.Action 8.Strengthen health emergency preparedness and response:Include oral health in national emergency preparedness and response plans.Ensure safe and unin-terrupted essential oral health services during health emergencies or other hu-manitarian crises,in accordance with WHO operational guidance on maintaining essential health and oral health services.Action 9.Bolster response to noma,where relevant:In countries affected by noma,de-velop and implement a national noma action plan that is integrated with existing regional or national programmes,such as those targeting neglected tropical dis-eases,vaccination and/or nutrition.Actions for the WHO secretariatAction 10.Lead and coordinate the Global Oral Health Agenda:Drive initiatives to de-fine and update the Global Oral Health Agenda and monitor its implementation.Coordinate the work of other relevant entities of the United Nations system,de-velopment banks and regional and international organizations related to oral health.Set the general direction and priorities for global oral health advocacy,partnerships and networking.Advocate for oral health at relevant high-level meetings and platforms,such as the WHO Global NCD Platform,the United Na-tions High-Level Meeting on Universal Health Coverage and the High-Level Meet-ing of the United Nations General Assembly on the Prevention and Control of NCDs.Accelerate implementation of the action plan by organizing a WHO global oral health summit involving key stakeholders.Action 11.Mobilize resources and funding for oral health:Explore and pursue funding op-tions to strengthen WHO capacities in oral health at global,regional and country levels and enable timely and appropriate technical support to countries.Strive to increase the number of dedicated staff at all levels of the organization,includ-ing operational budgets for programmatic work at global,regional and country levels.Advocate to increase resource allocation to oral health within the NCD agenda to ensure adequate staffing and programmatic activities.Include oral health in bi-and multi-lateral conversations with Member States and partners to mobilize resources for WHO oral health activities.Follow WHOs Framework of Engagement with Non-State Actors and engage with nongovernmental organiza-tions and philanthropic foundations to increase resources for implementing the Global Oral Health Action Plan,particularly in low-and middle-income settings.Action 12.Support implementation of the Global Oral Health Agenda:Provide techni-cal assistance upon request of Member States and prioritize support to low-and middle-income settings for developing,implementing and sustaining of their na-tional oral health plans.Create a global technical advisory group on oral health to strengthen international and national action and accelerate implementation Action area for strategic objective 1:oral health governance 11of the Global Oral Health Agenda.Continue working with global partners,includ-ing the United Nations Interagency Task Force on the Prevention and Control of NCDs,WHO collaborating centres and non-State actors in official relation with WHO,to establish networks for building capacity in oral health promotion,care,research and training.Establish or strengthen regional oral health policy,plan-ning and support capacities to address countries technical support needs for implementation of the Global Oral Health Action Plan,including data collection for its monitoring framework.Action 13.Fulfil the mandates given to the WHO Secretariat in the resolution on oral health:Continue to update technical guidance to ensure safe and uninterrupted dental services,including in health emergencies.By 2024,develop“best buy”in-terventions on oral health,as part of the updated Appendix 3 of the Global Action Plan for the Prevention and Control of NCDs 20132030 and integrated into the WHO UHC Compendium of health interventions.By 2023,include noma in the planned WHO review process to consider the classification of additional diseas-es within the road map for neglected tropical diseases 20212030.By 2025,de-velop technical guidance on environmentally friendly and less invasive dentistry to support countries with their implementation of the Minamata Convention on Mercury.Report back to the WHO governing bodies on progress and results until 2031 as part of the consolidated report on NCDs.Proposed actions for international partnersAction 14.Advocate for the Global Oral Health Action Plan:Develop technical expertise related to oral health as part of the support mandate of development partners and donor organizations.Promote oral health in alignment with the Global Oral Health Action Plan by including it as a topic in meetings within and outside of the health sector,such as donor,bi-and multi-lateral government meetings,confer-ences and other forums.Action 15.Increase resources for oral health:Intensify efforts by development partner and donor organizations to address oral health and other NCDs as part of the global NCD and UHC agendas.Expand financial,technical and human resource support.Use innovative financial mechanisms in programming for health,edu-cation and social protection.Action 16.Support country implementation of the Global Oral Health Action Plan:Re-inforce national capacities and resources for oral health through provision of technical and financial support.Help establish and sustain national technical working groups on oral health involving donors,development partners and the national government.Strengthen capacities of academic institutions and other non-State actors to act and advocate effectively.Prioritize support to low-and middle-income countries for developing,implementing and sustaining their na-tional oral health plans.12Global strategy and action plan on oral health 20232030 Proposed actions for civil society organizationsAction 17.Promote a whole-of-government approach to oral health:Advocate for inte-grating management of oral diseases and other NCDs into primary health care.Engage in multisectoral coordination mechanisms to deliver on oral health and other NCD targets within and beyond the health sector.Action 18.Advance oral health as a public good:Collaborate among civil society organi-zations,including oral health professional associations,to promote and protect oral health as a public good.Monitor and raise awareness of inappropriate part-nerships in which there are conflicts of interest or undue influence.Participate in the development of government guidance on private sector engagement in oral health and NCD programmes.Advocate for governments to phase out subsi-dies for unhealthy foods and drinks.Support taxation of unhealthy commodities,such as tobacco,alcohol and food and beverages with high free sugars content,in line with the provisions of the Framework Convention on Tobacco Control,the WHO Global Strategy to Reduce the Harmful Use of Alcohol and other WHO guid-ance documents.Promote a holistic approach to tackling antimicrobial resist-ance based on the United Nations Sustainable Development Cooperation Frame-work.Include the oral health workforce in such measures.Action 19.Hold governments accountable to global oral health targets:Participate in regular monitoring of national NCD and UHC work,including development and use of oral health targets and indicators.Strengthen independent accountability efforts related to oral health.Advocate for the operationalization of oral health services as part of UHC.Action 20.Include people affected by oral diseases and conditions:Call for and partici-pate in inclusive oral health governance mechanisms.Ensure that institutional-ized oral health decision-making processes engage people living with oral dis-eases,special care needs or disabilities as well as oral health professionals.Proposed actions for the private sectorAction 21.Align activities with global and national public health priorities:Use the Global Oral Health Action Plan and relevant regional and national policy guid-ance to incorporate public health principles and priorities in private sector activ-ities to promote oral health.Action 22.Support implementation of the Global Oral Health Action Plan:Identify areas for meaningful and appropriate engagement to support oral health public health priorities at the global,regional or national level.Respect rules of engagement set by public entities and government partners,including voluntary commit-ments and mandatory measures,such as advertising for children.Ensure envi-ronmental and social responsibility and accountability in oral health practices.Proposed actions for member states Actions for the WHO secretariat Proposed actions for international partners Proposed actions for civil society organizations Proposed actions for the private sectorAction area forstrategic objective 2:oral health promotionand oral disease prevention14Global strategy and action plan on oral health 20232030 Action area for strategic objective 2:oral health promotion and oral disease prevention26.Strategic objective 2 aims to address the social and commercial determinants and risk factors of oral diseases and conditions,with the goal of enabling all people to achieve the best possible oral health.This objective calls for evidence-based,cost-effective and sustainable interventions to promote oral health and prevent oral diseases and conditions.At the upstream level,oral health promotion includes creating public policies and fostering community action to improve peoples control over their oral health and to promote oral health equity.At the midstream level,oral health promotion and oral disease prevention interventions can be implemented in key settings,such as educational venues,schools,workplaces and care homes.At the downstream level,oral health ed-ucation supports the development of personal,social and political skills that enable all people to achieve their full potential for oral health self-care.27.Prevention efforts target key risk factors and the social and commercial determinants of oral dis-eases and conditions.These initiatives should be fully integrated and mutually reinforcing with other relevant strategies to prevent NCDs and regulatory policies to reduce or eliminate tobacco use,harmful alcohol use,unhealthy diets and high intake of free sugars.Prevention efforts should also include safe and cost-effective community-based methods to prevent dental caries,such as the use of quality fluoride toothpaste,topical fluoride application and access to systemic fluoride,where appropriate.Proposed actions for member statesAction 23.Intensify upstream health promotion and prevention approaches:Ensure that a national oral health policy addresses common risk factors as well as social and commercial determinants of dental caries,severe periodontal disease,tooth loss,oral cancer,oro-dental trauma,cleft lip and palate and noma,where it is prevalent.Support initiatives to coordinate and accelerate the response to oral diseases and conditions and other NCDs,including health promotion and dis-ease prevention focusing on common risk factors,determinants and inequalities across the life course.2GLOBAL TARGETS FOR STRATEGIC OBJECTIVE 2By 2030,50%of countries have national guidance on optimal fluoride delivery for oral health of the population.By 2030,50%of countries implement policy measures aiming to reduce free sugars intake.Global target 2.1:Policies to reduce free sugars intakeGlobal target 2.2:Optimal fluoride for population oral health50Ption area for strategic objective 2:oral health promotion and oral disease prevention15Action 24.Support policies and regulations to limit intake of free sugars:Accelerate ini-tiatives to transform the food environment in line with WHOs recommendations.Implement policies to reduce consumption of free sugars.Promote availability of healthy foods and beverages.Consider,when appropriate to national context,implementing health taxes,particularly taxation of food and beverages with high free sugars content.Advocate for earmarking such tax revenue for oral health care and health promotion,depending on country context.Collaborate with other line ministries:to limit package sizes;include more visible,simple and transparent la-belling of unhealthy foods and beverages;strengthen regulation of marketing and advertising of such products to children,adolescents and their parents;and avoid sponsorship by related companies for public and sports events.Work with the pri-vate sector to reduce portion sizes and reformulate products to decrease levels of free sugars,including medicines for children with high free sugars content.Action 25.Support policies and regulations to reduce tobacco consumption and be-tel-quid and areca-nut chewing:Accelerate full implementation of the WHO Framework Convention on Tobacco Control.Implement the WHO MPOWER pack-age of policies and interventions,including offering people help to quit tobacco use;warning about the dangers of tobacco;enforcing bans on advertising,pro-motion and sponsorship;and raising taxes on tobacco products.Integrate brief interventions for tobacco use into oral health programmes in primary care.Reg-ulate electronic cigarettes and all other nicotine-containing products in the same way as tobacco products.Where relevant,develop or strengthen actions for re-ducing betel-quid and areca-nut chewing,including advocating for legislation to ban their sale.Action 26.Support policies and regulations to reduce the harmful use of alcohol:Im-plement the WHO SAFER initiative of the five most cost-effective interventions to reduce alcohol-related harm,including strengthening restrictions on alcohol availability;advancing and enforcing drink-driving counter measures;facilitating access to screening,brief interventions and treatment;enforcing bans or com-prehensive restrictions on alcohol advertising,sponsorship and promotion;and raising prices on alcohol through excise taxes and pricing policies.Action 27.Optimize the use of fluorides for oral health:Develop or update national guid-ance related to optimal fluorides for population oral health that addresses the universal availability of systemic fluorides(e.g.,water,salt,milk)or topical flu-orides(e.g.,toothpastes,varnishes,gels,rinses).Take into consideration needs and disease burdens across the life course,the fluoride levels present in natural waters,available resources and technical,political and social factors.Depending on the country context and feasibility,consider adjusting water fluoride to safe,optimal levels for protection against dental caries,which may require adding or removing fluoride from drinking water as recommended by national and interna-tional guidance.Action 28.Advocate for fluoride toothpaste as an essential health product:Implement measures to improve the affordability and availability of fluoride toothpaste.Re-duce or eliminate taxes,tariffs and other fiscal measures.Explore bulk purchas-ing or manufacturing agreements for use of fluoride toothpaste in community 16Global strategy and action plan on oral health 20232030 settings.Strengthen quality and labelling of fluoride toothpaste in accordance with ISO Standard 11609 by developing national standards and quality controls.Enhance measures to protect consumers from low quality,harmful or counterfeit products.Consider adopting norms that detail available fluoride content,includ-ing methods for standardizing laboratory analysis to ensure product efficiency.Advance environmentally sound practices along the fluoride-toothpaste produc-tion and supply chain.Promote and incentivize effective self-care and oral hy-giene by making affordable,quality fluoride toothpaste universally available.Action 29.Review and scale up mid-stream promotion and prevention measures:Col-laborate in community development and action for oral health.Facilitate so-cial mobilization and engage and empower a diverse range of actors,including women as change agents in families and communities.Foster dialogue,catalyse societal change and address oral diseases and conditions and their social,envi-ronmental and economic determinants to improve oral health equity.Promote and implement vaccination of girls and boys against human papillomavirus to address cervical and oro-pharyngeal cancers,in accordance with national and international guidance.Encourage early detection of oral cancer in high-risk groups,linked with timely diagnostic work up and comprehensive cancer treat-ment,in settings with a significant disease burden.Action 30.Expand oral health promotion in key settings:Integrate oral health in health promotion programmes in schools,workplaces,long-term care facilities,hospi-tal and other health care settings,community-based settings and public venues.Partner in these efforts with key stakeholders across sectors,including city and local authorities,professional organizations,community-based organizations and civil society at large.Promote and consider establishing public settings where consumption of free sugars is discouraged and sugar-sweetened beverag-es are banned.Action 31.Achieve comprehensive promotion of oral health in schools:Create support-ive environments for oral health promotion in schools,preschools and other educational settings as part of comprehensive school health programming.Im-prove access to clean water,sanitation and hygiene services;increase availabil-ity of healthy food options;eliminate foods high in salt,free sugars and trans fats;and ban sugar-sweetened beverages,tobacco use and alcohol use on and around the premises.Collaborate in joint health and education ministry over-sight of school health and feeding programmes,including creating an environ-ment that supports healthy choices in schools and educational settings.Strive for integrated monitoring of education,school health,and water,sanitation and hygiene based on national,regional or international guidance and initiatives,in-cluding the WHO health-promoting schools initiative and the WHO and UNESCO Guidelines on School Health Services.Improve school linkages with the formal health care system.Establish rules and regulations for ethical commercial sup-port and sponsorship in schools.Action 32.Fortify and improve downstream promotion and prevention measures:De-velop and implement evidence-based,cost-effective,sustainable,and age-ap-propriate interventions to prevent oral diseases and promote oral health.Include Action area for strategic objective 2:oral health promotion and oral disease prevention17oral health in broader health communication,health education and literacy cam-paigns to raise awareness and empower people for prevention through self-care,oral hygiene and early detection of oral diseases.Draw on the WHO Mobile Tech-nologies for Oral Health implementation guide to promote oral health literacy among individuals,communities,policy makers,the media and civil society us-ing digital health technologies.Tailor interventions to address oral health along the life course,such as programmes targeting children,adolescents,pregnant women,parents and older adults,with special consideration for poor,vulnera-ble and/or marginalized members of the society.Ensure quality monitoring and evaluation of health promotion and prevention programmes.Action 33.Strengthen personal,social and political oral health skills:Support all peo-ple to achieve their full potential for oral health self-care and oral health care of others.Promote twice-daily tooth brushing with fluoride toothpaste and other forms of oral health self-care and care for others.Employ skills-based oral hy-giene education in communities,schools and primary care settings.Include oral health in population health education campaigns and relevant digital and social media platforms.Advocate for supportive policies to strengthen the availability and affordability of fluoride toothpaste.Actions for the WHO secretariatAction 34.Integrate oral health promotion in relevant WHO guidance:Consider estab-lishing a WHO internal coordination mechanism to facilitate systematic integra-tion of oral health in related policies,strategies and technical documents.Inte-grate oral health in technical guidance on health taxes.Encourage research with WHO collaborating centres and other research entities on interventions to effec-tively address the social and commercial determinants of oral health.Action 35.Provide technical guidance for oral health promotion and oral disease pre-vention:Recommend cost-effective,evidence-based interventions for oral health promotion and disease prevention by 2024 as part of the updated Appen-dix 3 of the Global Action Plan for the Prevention and Control of NCDs 20132030 and the WHO UHC Compendium of health interventions.Action 36.Hold to account economic operators in the production and trade of products harmful to oral health:Strengthen technical support and guidance on nutri-tion,labelling and fiscal measures to promote healthy food options.Encourage private-sector transparency and alignment with mandatory regulations and vol-untary codes of practice to reduce the marketing,advertising and sale of prod-ucts harmful to oral health,such as tobacco products and food and beverages that are high in free sugars.Proposed actions for international partnersAction 37.Target risk factors and determinants of oral health:Integrate oral health into new or existing programmes that address NCDs more broadly,including com-mon risk factors and determinants of health.Support and conduct research to 18Global strategy and action plan on oral health 20232030 strengthen the evidence for interventions that effectively target the determi-nants of oral health,including those that reduce oral health inequalities.Action 38.Consider oral health in policy impact assessments:Ensure that oral health is considered when conducting health,inequality or environmental impact assess-ments in trade,food,environment,finance and other sectors,so that unintended health impacts can be avoided and mitigation measures are put in place.Proposed actions for civil society organizationsAction 39.Mobilize support for oral health promotion:Facilitate community action for health promotion among diverse groups,such as nongovernmental organiza-tions,academia,media,human rights agencies,faith-based organizations,la-bour and trade unions and organizations working with poor,vulnerable and/or marginalized people.Support the development of personal,social and advocacy skills to enable all people to achieve their full potential for effective self-care and comprehensive oral hygiene,including persons with impaired motor skills,such as children,people with disabilities and older individuals.Action 40.Advocate for policies and regulations for oral disease prevention:Support policies aimed at creating healthy environments and settings,such as healthy school meals,tobacco-free environments and related sales restrictions for mi-nors.Advocate for the implementation of health taxes,including those for foods and beverages high in free sugars.Promote national action on the commercial determinants of health,such as mandatory legislation and regulation to limit the influence of food and drink corporations.Call for transparent conflict-of-interest policies between commercial corporations and oral health policy-makers,dental schools and oral health researchers to limit undue influences and safeguard pub-lic health interests.Action 41.Ensure civil society inclusion in policy development:Advocate for including professional,provider and patient organizations and diverse other civil socie-ty organizations in the development and implementation of policies related to oral health promotion,common risk factors and the determinants of oral dis-eases and other NCDs.Strengthen transparency and commitment by holding all stakeholders accountable to the Global Oral Health Action Plans actions on oral health promotion and oral disease prevention.Proposed actions for the private sectorAction 42.Reduce marketing,advertising and sale of harmful products:Prioritize moni-toring,transparency and compliance with voluntary and legally binding policies and regulations related to healthy settings,protection of vulnerable population groups,marketing,advertising and sponsorship,depending on country context.Consider reformulation of products to reduce intake of free sugars.Action 43.Improve affordability and quality of fluoride products for oral health:Coop-erate with governments to improve the affordability and quality of fluoride-con-taining products for oral health.Ensure that tax reductions or subsidies applied Action area for strategic objective 2:oral health promotion and oral disease prevention19to such products are entirely reflected in lower consumer prices.Action 44.Implement occupational oral health measures:Strengthen the commitment and contribution to oral health by implementing measures at the workplace,in-cluding through good corporate practices,workplace health and wellness pro-grammes and health insurance coverage for employees,according to country context.Proposed actions for member states Actions for the WHO secretariat Proposed actions for international partners Proposed actions for civil society organizations Proposed actions for the private sectorAction area forstrategic objective 3:health workforce 22Global strategy and action plan on oral health 20232030 Action area for strategic objective 3:health workforce28.Strategic objective 3 aims to develop innovative workforce models and to revise and expand com-petency-based education to support new skill mixes.Progress towards oral health services as part of UHC requires health workers who are educated and empowered to provide the oral health ser-vices that populations need.Central to this objective is the availability of skilled health workers in adequate numbers to ensure the delivery of an essential package of oral health care.Planning and prioritization of oral health services must be included in all national health workforce policies,plans or strategies and investment plans.29.More effective,innovative workforce models will probably include health professionals who tra-ditionally may not have been involved in oral health care working together with oral health pro-fessionals to provide an essential package of oral health services.Developing and expanding the role of oral health care providers working autonomously at the mid-level is particularly important.Reform of intra-and inter-professional education and collaborative practice will be key to fully inte-grating oral health services at the primary care level and into broader health systems.Professional oral health education must go beyond developing a fundamental clinical skill set to incorporate community health,public health,leadership and research competencies.Proposed actions for member statesAction 45.Foster innovative oral health workforce models:Develop and implement workforce models that enable sufficient numbers of adequately trained,mo-tivated and well-distributed health workers to provide oral health services as members of collaborative and interprofessional primary health care teams at all levels of care.Review and update national legislative and regulatory policies for licensing,accreditation and scopes of practice to support flexible workforce models and competency-based education and practice.Explore task shifting and increase the number and availability of oral health providers working autono-mously at the mid-level.Facilitate career-transition pathways between profes-sional tracks to increase flexibility and deployment of oral health providers in un-derserved areas.Include basic oral health promotion and preventive oral health care as a core competency for key health care professionals,such as doctors,nurses and pharmacists.Action 46.Increase capacity to deliver oral health services as part of UHC:Expand cov-erage of essential oral health care by planning for the availability,accessibility,3GLOBAL TARGETS FOR STRATEGIC OBJECTIVE 3Global target 3:Innovative workforce model for oral health50%By 2030,50%of countries have an operational national health workforce policy,plan or strategy that includes workforce trained to respond to population oral health needs.Action area for strategic objective 3:health workforce23acceptability and quality of skilled health workers able to deliver an essential package of oral health care for all,including for poor,vulnerable and/or margin-alized populations.Ensure that investment in human resources for oral health is efficient,sustainable and aligned with the current and future needs of the popu-lation.Include oral health workforce planning within national health workforce plans,policies and strategies.Develop comprehensive investment plans to scale up the oral health workforce.Consider designing a standardized national com-petency-based training curriculum for oral health aligned with the WHO Global Competency and Outcomes Framework for Universal Health Coverage,which guides the standards of education and practice for health workers in primary care.Action 47.Strengthen collaborative,cross-sectoral workforce governance:Establish and enable professional councils and associations at the national level to devel-op,regularly review and adapt accreditation mechanisms and regulations.Pro-mote portability of licensure across countries to support innovative oral health workforce models.Include standards of practice and professional behaviour,under the oversight of the Ministry of Health and fully integrated with national health workforce planning.Leverage existing collaborations among the minis-tries of health,labour,economy,finance and education and engage with relat-ed professional councils and associations,to ensure occupational health and safety,health worker rights,reduced biases in the workforce and appropriate remuneration.Foster interprofessional collaboration,including interdisciplinary teamwork in oral health care and scale-up of surveillance capacities for commu-nicable and noncommunicable conditions.Action 48.Reform intra-and inter-professional oral health education:Prepare students for collaborative practice and integrating oral health into primary health care.Promote and safeguard equitable access to oral health professional education to increase socio-economic,gender,disability,ethnic and geographic diversity and cultural competency of the oral health workforce.Action 49.Improve oral health workforce curricula and training:Reform education to prioritize competencies in public health,health promotion,disease prevention,evidence-informed decision-making,digital oral health,service planning and the social and commercial determinants of health.Ensure the curriculum pro-vides oral health workers with clinical and public health competencies to pre-vent and treat the most common oral diseases with essential oral health care and rehabilitation measures in a primary care context.Encourage and consider mak-ing it mandatory for professional organizations and dental schools to educate and train oral health professionals and students on the use of evidence-based,mercury-free alternatives for dental restoration and on best practices for waste management in oral health care facilities.Support training on rational antimi-crobial prescribing and infection control to prevent the spread of antimicrobial resistance.Action 50.Strengthen oral health professional accreditation:In accordance with coun-try regulations,create or improve accreditation mechanisms for public and pri-vate oral health education and training institutions.Support effective oversight 24Global strategy and action plan on oral health 20232030 bodies to ensure minimum quality standards of oral health education.Establish standards for social accountability and social and commercial determinants of health.Work with professional associations to define oral health specializations and their training and accreditation requirements,recognizing the priority of es-sential oral health care and public health specialists while balancing the demand for advanced and specialist oral health care.Strengthen awareness of nonclin-ical career pathways among students in public health,epidemiology,research and other areas.Make life-long professional continuing education mandatory to retain accreditation and license to practise.Actions for the WHO secretariatAction 51.Explore innovative workforce models for oral health:Initiate regional and national workforce assessments to inform the development of innovative work-force models for oral health service delivery,based on the WHO Competency Framework for Universal Health Coverage and the objectives of the Global Strat-egy on Human Resources for Health:Workforce 2030.Consider developing ca-pacity building programmes as part of institutional and educational workforce reform,with the support of the WHO Academy.Action 52.Provide normative guidance and technical support for oral health workforce reform:In collaboration with partners,disseminate best practices on assess-ment of health system needs,reform of education policies,analysis of health labour markets,and costing of national policies,plans and strategies on human resources for health,taking into account the organization of the national oral health team.Review and strengthen tools,guidelines and databases related to human resources for NCDs,including oral diseases and conditions,in collabora-tion with the WHO health workforce department.Action 53.Strengthen country-level reporting on human resources for oral health:Gather,analyse and report public and private oral health workforce data as part of the monitoring framework of the Global Oral Health Action Plan.Track pro-gress on implementation of workforce-related actions.Support country-level data collection on the oral health workforce,including leveraging the national health workforce accounts reporting system.Proposed actions for international partnersAction 54.Champion the workforce reform agenda:Engage international professional,research and dental education associations to align with the workforce reform agenda and support regional and national member associations.Support inno-vative oral health workforce models by focusing international and regional sup-port on countries with the most critical workforce shortages.Consider financial and grant support for assessing,strengthening and diversifying the oral health workforce.Action 55.Advance data,information and accountability:Reinforce integrated health and oral health workforce planning.Provide technical support for collecting,Action area for strategic objective 3:health workforce25analysing and using data on the national oral health workforce for improved planning and accountability.Align these efforts with the health labour market framework and the national health workforce accounts reporting system.Action 56.Improve oral health training and accreditation:Under the oversight of the Ministry of Health and in collaboration with professional associations,integrate basic competencies for oral health in health worker training programmes on pre-vention and management of major NCDs.Promote mutual recognition of profes-sional diplomas and qualifications by regional and national accreditation entities to enable free movement,license portability and practice between countries and geographic areas of need for oral health professional,in accordance with the WHO Global Code of Practice on the International Recruitment of Health Personnel.Proposed actions for civil society organizationsAction 57.Collaborate to accelerate oral health workforce reform:For dental councils and oral health professional associations,develop appropriate task-sharing and interprofessional collaboration models and strengthen effective accreditation and regulation processes for improved workforce competency,quality and ef-ficiency,under government leadership and through collaboration with commu-nity and patient organizations,where appropriate.For academic training and research institutions,train the workforce to minimize the environmental impact of oral health services and prioritize oral health worker competencies in line with the WHO Competency Framework for Universal Health Coverage and the Global Strategy on Human Resources for Health:Workforce 2030.Action 58.Strengthen oral health in primary health care:For dental councils and oral health professional associations,foster ongoing self-reflection of the dental profession on the goal of improving access to and quality of oral health care in primary health care and patient safety as a societal responsibility within and be-yond dentistry.Action 59.Improve quality of oral health care through continuing education:For dental councils and oral health professional associations,support continuing educa-tion of the oral health workforce.Develop or review codes of practice and similar frameworks to enhance management of potential conflicts of interest and undue influences,including when dental and pharmaceutical companies and other pri-vate-sector entities sponsor professional education and conferences.Proposed actions for the private sectorAction 60.Align private and public oral health workforce training:Ensure involvement and alignment of public and private oral health workforce training institutions in meeting the requirements of national health workforce policies,plans or strat-egies aimed at addressing current and future population health needs.Adapt concepts and programmes of private oral health education to include competen-cy-based training.Strengthen oral health education in the public interest.Proposed actions for member states Actions for the WHO secretariat Proposed actions for international partners Proposed actions for civil society organizations Proposed actions for the private sectorAction area forstrategic objective 4:oral health care28Global strategy and action plan on oral health 20232030 Action area for strategic objective 4:oral health care30.Strategic objective 4 aims to integrate essential oral health care into primary health care and en-sure related financial protection and essential supplies.This objective seeks to increase access by the entire population to safe,effective and affordable essential oral health care as part of national UHC benefits packages.These promote oral health and prevent and treat the most prevalent and/or severe oral diseases and conditions,including appropriate rehabilitative services and referral.Health workers who provide oral health services should be active members of the primary health care team.31.Financial protection through expanded pre-payment financing arrangements supported by ade-quate levels of public spending,is one of the cornerstones of UHC.Ensuring the reliable availability,affordability and distribution of essential medical consumables,generic medicines and other den-tal supplies is also important for the management of oral diseases and conditions in primary health care and referral services.It is particularly important to explore ways to make oral health products more affordable in low-and middle-income settings,where resources are limited and the burden of oral diseases is increasing.32.Digital health technologies should be examined for their potential role in delivering of accessible,effective oral health promotion and essential oral health care.This may include developing pol-icy,legislation and infrastructure to expand the use of digital health technologies.Digital health technologies may also improve remote access and consultation for early detection and referral to services for the management of oral diseases and conditions.The benefits of digital health tech-nologies need to be balanced against potentially negative effects,including those related to digital exclusion and the challenges of data protection.Proposed actions for member statesAction 61.Establish an essential oral health care package:Coordinate a national stake-holder-engagement process to review evidence,assess current service capacity 4GLOBAL TARGETS FOR STRATEGIC OBJECTIVE 4By 2030,50%of countries include dental preparations listed in the WHO Model Lists of Essential Medicines in their national essential medicines list.By 2030,80%of countries have oral health care services generally available in primary health care facilities.Global target 4.1:Integration of oral health in primary careGlobal target 4.2:Availability of essential dental medicines50tion area for strategic objective 4:oral health care 29for oral health care and agree on cost-effective oral health interventions as part of the national UHC benefits package.Ensure that the package includes emer-gency care,prevention and treatment of common oral diseases and conditions and essential rehabilitation.Prioritize the prevention and treatment of dental caries with minimal intervention.Advocate that national UHC includes safe,affordable essential oral health care based on the WHO UHC Compendium of health interventions and oral health-related interventions in Appendix 3 of the Global Action Plan for the Prevention and Control of NCDs 20132030.Using the available evidence,support introducing remuneration systems that incentivize prevention over treatment and models of good practice.Action 62.Integrate oral health care into primary health care:Develop and review all aspects of primary health care services and plan to integrate oral health care at all service levels,including required staffing,skill mix and competencies.Imple-ment workforce models that produce sufficient numbers of adequately trained health workers to provide oral health services within primary health care teams at all levels of care.Establish referral pathways and support mechanisms that streamline coordination of care with other areas of the health system.Consider including private oral health providers through appropriate contracting and/or reimbursement schemes.Explore how to optimize private oral health care pro-viders engagement in such schemes,particularly in countries where they make up a sizeable proportion of providers.Action 63.Work towards integrated oral health services as part of UHC:Expand cover-age through on-demand care in primary care facilities using an essential oral health care package.Assess,strengthen and rehabilitate infrastructure for oral health services to support the quality and scope of needed oral health care.En-sure that oral health care is of sufficient quality to be effective and safeguards pa-tient safety.Establish an oral health quality monitoring and management system for both the private and public sectors,including periodic quality-improvement measures.Action 64.Guarantee financial protection for essential oral health care:Establish ap-propriate financial protection for patients through expanded payment financing arrangements supported by adequate levels of public spending,in accordance with national UHC strategies.Promote and safeguard access of poor,vulnerable and/or marginalized population groups to essential oral health care packages without financial hardship.For such groups,consider appropriate co-payment regulations supported by adequate levels of public spending.Action 65.Ensure essential oral health supplies:Prioritize the availability and distribu-tion of essential oral health care supplies and consumables as part of public procurement mechanisms for primary health care.Establish or update national lists of essential medicines that include supplies and medicines required for oral health services,aligned with the WHO Model Lists of Essential Medicines,which encompass the medications considered to be effective and safe to meet the most important needs in a health system.30Global strategy and action plan on oral health 20232030 Action 66.Strengthen action against antimicrobial resistance:Promote stewardship and engagement in initiatives to prevent and control the spread of antimicrobial re-sistance.Develop guidance on rational antibiotic use for oral health profession-als.Strengthen standard procedures for infection prevention and control in line with WHO and other international and national guidance.Include oral health professionals in initiatives to prevent and control the spread of antimicrobial re-sistance.Action 67.Promote safe,environmentally sound,mercury-free products and minimal intervention:Advocate for the prevention and treatment of dental caries with minimal intervention.Restrict the use of dental amalgam to its encapsulated form.Exclude or do not allow the use of mercury in bulk form by dental practi-tioners.Exclude or do not allow or recommend against the use of dental amal-gam for the dental treatment of deciduous teeth,patients under 15 years of age and pregnant and breastfeeding women,except when considered necessary by the dental practitioner based on the needs of the patient.Promote the use of mercury-free alternatives for dental restoration.Discourage insurance policies and programmes that favour use of dental amalgam over mercury-free dental restoration.Action 68.Reinforce best environmental practices:In collaboration with the Ministry of Environment,ensure that measures are in place to reduce the environmental impact of oral health services.Minimize carbon emissions and the use and pro-duction of waste from single-use plastic and nonbiodegradable materials.Use natural resources,such as water and energy sources,in sustainable ways.Fol-low best environmental practices in dental facilities to reduce releases of mer-cury and mercury compounds to water and land.When expanding essential oral health care services,explore ways to minimize their impact on the environment,such as through promotion of oral health self-care and preventive lifestyle and behavioural changes,as well as careful treatment planning and efficient use of digital technologies.Action 69.Optimize digital technologies for oral health care:Support digital access and consultation for oral disease early detection,management and referral.Monitor and evaluate the effectiveness and impact of such interventions.Integrate digi-tal access and consultation into interprofessional platforms to facilitate access for patients.Draw on the WHO Mobile Technologies for Oral Health implemen-tation guide to improve oral health literacy,health worker training,early detec-tion of oral diseases and oral health surveillance within national health systems.Develop and strengthen data protection and privacy policies to safeguard con-fidentiality,patient access to personal data and appropriate consent to data use.Strengthen access and capacity for using digital technologies to ensure that digital health approaches do not increase inequalities and that services remain accessible to all,aligned with the WHOITU Global Standard for Accessibility of Telehealth Services.Action area for strategic objective 4:oral health care 31Actions for the WHO secretariatAction 70.Provide guidance on essential oral health care and cost-effective oral health interventions:By 2024,recommend interventions as part of the updated Appen-dix 3 of the Global Action Plan for the Prevention and Control of NCDs 20132030 and the WHO UHC Compendium of health interventions.Update interventions periodically to consider the emergence of new evidence of costeffectiveness.Support Member States to develop specific definitions of essential oral health care for their contexts and implement cost-effective interventions for oral health as part of other NCD initiatives.Facilitate learning and sharing of best practices related to UHC and oral health care in primary care.Action 71.Advocate for digital oral health:Drawing on the Global Strategy on Digital Health 20202025 and the WHO Mobile Technologies for Oral Health implemen-tation guide,provide technical guidance and support for digital oral health.En-courage countries to share lessons learned and best practices related to digital oral health technology.Action 72.Accelerate implementation of the Minamata Convention on Mercury:In col-laboration with the Secretariat of the Minamata Convention on Mercury and the United Nations Environment Programme,support countries with implementing the provisions of the Convention,particularly those related to the phase down in use of dental amalgam in Environment Facility 7(GEF-7)project“Accelerate implementation of dental amalgam provisions and strengthen country capaci-ties in the environmentally sound management of associated wastes under the Minamata Convention”and relevant future GEF projects.Develop technical guid-ance on environmentally sound and less invasive dentistry.Proposed actions for international partnersAction 73.Strengthen oral health services as part of UHC:Consider including oral health services in programmatic and budget planning for UHC.Support the develop-ment and implementation of a package of essential oral health services,par-ticularly in low-and middle-income settings.Provide platforms to share les-sons learned and key success factors to integrate oral health services into UHC schemes.Proposed actions for civil society organizationsAction 74.Mobilize stakeholders for oral health care:Consider establishing multistake-holder advisory committees for NCDs,including oral diseases and conditions,at national and local levels of government.Ensure representation of civil society organizations to strengthen participation and ownership.Encourage new and support existing civil society organizations to serve as advocates and catalysts to increase access to essential oral health care and promote its inclusion in UHC.Action 75.Help mitigate environmental impacts of oral health care:Advocate for envi-ronmentally sound practices and sustainable use of natural resources in the con-32Global strategy and action plan on oral health 20232030 text of oral health services,including accelerating the phase down in use of den-tal amalgam and minimizing the use of single-use plastic and non-biodegradable materials.Proposed actions for the private sectorAction 76.Invest in digital oral health for all:Amplify research on and development of digital oral health care devices and technologies that are low-cost and simple to use,in support of population-based interventions.Action 77.Commit to environmentally responsible manufacturing:Develop,produce and market oral health care products and supplies that are cost-effective,envi-ronmentally responsible and sustainable.Engage with governments to improve availability and affordability of such products through bulk purchasing and other cost-saving approaches to public procurement.Accelerate research on and de-velopment of new mercury-free,safe and effective dental filling materials.Action 78.Establish sustainable public-private partnerships:Engage manufacturers and suppliers of oral care products in ethical,transparent and long-term part-nership agreements with key national actors,in line with public health princi-ples and the Global Oral Health Action Plan.Prioritize dental caries prevention and health promotion,thereby minimizing the need for dental restoration.Im-prove access to essential oral health care and supplies,particularly in low-and middle-income settings,including supporting governmental initiatives to make these products more affordable.Encourage insurance policies and programmes that favour the use of quality alternatives to dental amalgam for dental restora-tion.Proposed actions for member states Actions for the WHO secretariat Proposed actions for international partners Proposed actions for civil society organizations Proposed actions for the private sectorAction area forstrategic objective 5:oral health information systems34Global strategy and action plan on oral health 20232030 Action area for strategic objective 5:oral health information systems33.Strategic objective 5 aims to enhance surveillance and health information systems to provide timely and relevant feedback on oral health to decision-makers.This objective involves developing more efficient and effective integrated health information systems that include oral health to inform planning,management and policy-making.At the national and subnational levels,strengthening information systems should include the systematic collection of data on oral health status,social and commercial determinants,risk factors,workforce,oral health services readiness and resource spending.These efforts should ensure that appropriate measures gather information on the oral health needs of populations to inform service reforms.Development and implementation of oral health information systems should be guided and supported by the monitoring framework of the Global Oral Health Action Plan,as relevant to country context.34.New oral health research methods,including high-resolution video,multispectral imaging and mobile technologies,can be explored to improve the quality of population-based oral health data while reducing costs and complexity.The improved systems should protect patient data,monitor patterns and trends in oral health inequalities and track the implementation and impact of existing policies and programmes related to oral health.Proposed actions for member statesAction 79.Strengthen oral health information systems:Support the development and improvement of oral health information and surveillance systems.Depending on country context,integrate oral health indicators into existing national health information systems,such as facility-based service reporting.Integrate surveil-lance of population health by incorporating oral health indicators into national NCD and UHC monitoring frameworks.Monitor risk factors and the social and commercial determinants of oral health inequalities.Improve oral health system and policy data,evaluation of oral health programmes and information on the oral health workforce in national health workforce accounts.Consider conduct-ing population-based oral health surveys or other appropriate surveillance spe-cific to oral diseases,including self-reported data collection and integration with existing NCD surveillance systems.Action 80.Integrate electronic patient records and protect personal health data:En-courage integration of electronic oral health patient records into medical and 5GLOBAL TARGETS FOR STRATEGIC OBJECTIVE 5By 2030,80%of countries have a monitoring framework for the national oral health policy,strategy or action plan.Global target 5:Monitoring implementation of the national oral health policy80tion area for strategic objective 5:oral health information systems 35pharmacological records and sharing data among public and private providers,to facilitate continuity of people-centred care as well as population-level health monitoring.Establish data protection and confidentiality regulations that pro-tect patient-related information while allowing anonymized data analysis and reporting,in accordance with national context.Ensure that patients have access to all information recorded and stored about them.Action 81.Use innovative methods for oral health data collection:Participate in periodic global WHO surveys that collect health system,NCD and other health informa-tion.Develop and standardize innovative methods for collecting and analysing oral health and epidemiological data using digital technologies.Explore applica-tions supported by artificial intelligence in mobile devices,opportunities provid-ed by more complex and larger data sets from new sources,and novel approach-es to generating comprehensive disease estimates.Action 82.Increase transparency and accessibility of oral health information:Make an-onymized information and appropriately disaggregated data on population oral health publicly available to inform research,analysis,planning,management,policy decision-making and advocacy.Consider creating centralized reposito-ries of data to promote standardization of data and reduce fragmentation across databases.Ensure alignment of the national oral health monitoring framework with the monitoring framework of the Global Oral Health Action Plan.Regularly report national data to WHO as proposed in the framework.Actions for the WHO secretariatAction 83.Track implementation and impact of the Global Oral Health Action Plan:Gather and analyse country data for the monitoring framework of the Global Oral Health Action Plan.Share findings as required within broader NCD reporting.Create an oral health data portal as part of WHOs data repository for health-re-lated statistics.Compile health systems information from multiple data sources to routinely update information on implementation of the Global Oral Health Action Plan.Adapt and update existing global WHO surveys and tools to enable tracking of progress implementing the Global Oral Health Action Plan.Action 84.Support integration of oral health in national health information systems:Develop guidance documents for effective strengthening of oral health informa-tion systems at global,regional,national and subnational levels.Engage with WHO collaborating centres and international partners,such as the Institute for Health Metrics and Evaluations Global Burden of Disease group,to improve indi-cators,data collection and inclusion,analysis methodology and interpretation of oral-health-related estimates.Build the trust of health professionals and the pub-lic in the capacity and value of integrated oral health monitoring and information systems.36Global strategy and action plan on oral health 20232030 Proposed actions for international partnersAction 85.Support the monitoring framework of the Global Oral Health Action Plan:Improve capacities of effective oral health information systems,surveillance,re-search and data analysis by providing appropriate tools and training opportuni-ties for all stakeholders as part of broader health system strengthening.Action 86.Advance oral health metrics:Promote the use of oral health indicators aligned with global health metrics used to assess the burden of disease,such as preva-lence and disability-adjusted life years,to strengthen usability of information in the context of the Sustainable Development Goals and other key global health agendas.Proposed actions for civil society organizationsAction 87.Promote oral health data protection and confidentiality:In accordance with country regulations,seek protection of patient and provider-related information while allowing anonymized data analysis and reporting for planning,evaluation and research.Proposed actions for the private sectorAction 88.Provide access to insurance data for research and service planning:Enable access to private oral health insurance data on coverage,health outcomes and economic information,in full compliance with national data protection policies.Proposed actions for member states Actions for the WHO secretariat Proposed actions for international partners Proposed actions for civil society organizations Proposed actions for the private sectorAction area forstrategic objective 6:ORAL HEALTH research agendas38Global strategy and action plan on oral health 20232030 Action area for strategic objective 6:oral health research agendas35.Strategic objective 6 aims to create and periodically update context-and needs-specific research that is focused on the public health aspects of oral health.This objective strives to create and im-plement new oral health research agendas that are oriented towards public health programmes and population-based interventions.Translation of research findings into practice is equally im-portant and should include the development of country-specific,evidence-informed clinical prac-tice guidelines.Researchers play an important role in supporting the development and evaluation of population oral health policies and evaluating and applying the evidence generated by public health interventions.Proposed actions for member statesAction 89.Reorient the oral health research agenda:Define national oral health research priorities to focus on public health and population-based interventions,taking into account the wider NCD,primary health care,UHC and health system context.Review and establish adequate public funding mechanisms for oral health re-search aligned with national priorities.Facilitate the dissemination of and align-ment with the national oral health research agenda among all national research institutions,academia and other stakeholders.Foster collaboration within and across countries,including multidisciplinary research,based on the principles of research ethics and equity in health research partnerships.Action 90.Prioritize oral health research of public health interest:Support research areas of high public health interest in addition to basic health research,such as research on rare oral diseases.Strengthen implementation and operation
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