Disclaimer POLITICAL ADVERTISEMENT * This is sponsored content from AstraZeneca. * The advertisement is linked to public policy debates on the future of cancer care in the EU. More information here. Europe has made huge strides in the fight against cancer.[1] Survival rates have climbed, detection has improved and the continent has become home to some of the world’s most respected research hubs.[2],[3] None of that progress came easy — it was built on years of political attention and cooperation across borders. However, as we look to 2026 and beyond, that progress stands at a crossroads. Budget pressures and tougher global competition threaten to push cancer and health care down the EU agenda. Europe’s Beating Cancer Plan — a flagship initiative aimed at expanding screening, improving early detection and boosting collaboration — is set to expire in 2027, with no clear plan to secure or extend its gains.[4],[5] “My [hope is that we can continue] the work started with Europe’s Beating Cancer Plan and make it sustainable… [and] build on the lessons learned, [for other disease areas] ” says Antonella Cardone, CEO of Cancer Patients Europe. A new era in cancer treatment Concern about the lapsing initiative is compounded by two significant shifts in health care: declining investment and increasing scientific advancement. Firstly, Europe has seen the increased adoption of cost-containment policies by some member states. Under-investment in Europe in cancer medicines has been a challenge — specifically with late and uneven funding, and at lower levels than international peers such as the US — potentially leaving patients with slower and more limited access to life-saving therapies.[6],[7],[8] Meanwhile, the U.S., which pays on average double for medicines per capita than the EU,[9] is actively working to rebalance its relationship with pharmaceuticals to secure better pricing (“fair market value”) through policies across consecutive administrations.[10] All the while, China is rapidly scaling investment in biotech and clinical research, determined to capture the trials, talent, and capital that once flowed naturally to Europe.[11] The rebalancing of health and life-science investment can have significant consequences. If Europe does not stay attractive for life-sciences investment, the impact will extend beyond cancer patient outcomes. Jobs, tax revenues, advanced manufacturing, and Europe’s leadership in strategic industries are all at stake.[12] Secondly, medical science has never looked more promising.[7] Artificial intelligence is accelerating drug discovery, clinical trials, and diagnostics, and the number of approved medicines for patients across Europe has jumped from an average of one per year between 1995 and 2000 to 14 per year between 2021 and 2024.[13],[14],[15], [7] Digital health tools and innovative medtech startups are multiplying, increasing competitiveness and lowering costs — guiding care toward a future that is more personalized and precise.[16],[17] Europe stands at the threshold of a new era in cancer treatment. But if policymakers ease up now, progress could stall — and other regions, especially the U.S. and China, are more than ready to widen the innovation gap. Recognizing the strategic investment Health spending is generally treated as a budget item to be contained. Yet investment in cancer care has been one of Europe’s smartest economic bets.[18],[19] The sector anchors millions of high-skilled jobs (it employs around 29 million people in the EU[11]) and attracts global life sciences investment. According to the European Commission, the sector contributes nearly €1.5 trillion to the EU economy.[12] Studies from the Institute of Health Economics confirm that money put into research directly translates into better survival outcomes.[20] The same report shows that although the overall spend on cancer is increasing, the cost per patient has actually decreased since 1995, suggesting that innovative treatments are increasing efficiency.[20] Those gains matter not only to patients and families, but to Europe’s long-term stability: healthier populations mean fewer costs down the line, stronger productivity, and more sustainable public finances.[20] Fixing Europe’s access gap Cancer medicines bring transformative value — to patients, to society and to the wider economy. [21] However, even as oncology therapies advance, patients across Europe are not benefiting equally. EFPIA’s 2024 Patients W.A.I.T. indicator shows that, on average, just 46 percent of innovative medicines approved between 2020 and 2023 were available to patients in 2024.[22] On average, it takes 578 days for a new oncology medicine to reach European patients, and only 29 percent of drugs are fully available in all member states.[23] This is not caused by a lack of breakthrough medicines, but by national policy mechanisms that undervalue innovation. OECD and the Institute for Health Economics data show that divergent HTA requirements, rigid cost-effectiveness thresholds, price-volume clawbacks, ad hoc taxes on pharmaceutical revenues and slow national reimbursement decisions collectively suppress timely access to new cancer medicines across the EU.[24] These disparities cut against Europe’s long-standing reputation as a collection of societies that values equitable, high-quality care for all of its citizens. It risks eroding one of the EU’s defining strengths: the commitment to fairness and collective progress. Cancer policy solutions for the EU Although this is ultimately a matter for member states, embedding cancer as a permanent EU priority — backed by funding, coordination, and accountability — could give national systems the incentives and strategic direction to buck these trends. These actions will reassure pharmaceutical companies that Europe is serious about attracting clinical trials and the launch of new medicines, ensuring that its citizens, societies and economies enjoy the benefits this brings. Europe’s Beating Cancer Plan delivered progress, but its expiry presents a pivotal moment. 2026 and beyond bring a significant opportunity for the EU to build on this by ensuring that member states implement National Cancer Control Plans and have clear targets and accountability on their national performance, including on investment and access. To do this, EU policymakers should consider three actions as an immediate priority with lasting impact: * Embed cancer and investment within EU governance. Build it into the European Semester on health with mandatory indicators, regular reviews, and accountability frameworks to ensure continuity. This model worked well during Covid-19 and should be adapted for non-communicable diseases starting with cancer as a pilot. * Secure stable and sufficient funding. The Multiannual Financial Framework must ensure adequate funding for health and cancer to encourage coordinated initiatives across member states. * Strengthen EU-level coordination. Ensure that pan-EU structures such as the Comprehensive Cancer Centres and Cancer Mission Hubs are adequately funded and empowered. These are the building blocks of a lasting European commitment to cancer. With action, Europe can secure a sustainable foundation for patients, resilience and continued scientific excellence. -------------------------------------------------------------------------------- [1] European Commission, OECD/European Observatory on Health Systems and Policies. 2023. State of Health in the EU: Synthesis Report 2023. Available at: https://health.ec.europa.eu/system/files/2023-12/state_2023_synthesis-report_en.pdf [Accessed December 2025] [2] Efpia. 2025. Cancer care 2025: an overview of cancer outcomes data across Europe. Available at: https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/ihe-cancer-comparator-report-2025/ [Accessed December 2025] [3] Cancer Core Europe. 2024. Cancer Core Europe: Advancing Cancer Care Through Collaboration. Available at: https://www.cancercoreeurope.eu/cce-advancing-cancer-care-collaboration/ [Accessed December 2025] [4] European Commission. 2021. Europe’s Beating Cancer Plan. Available at:https://health.ec.europa.eu/system/files/2022-02/eu_cancer-plan_en_0.pdf [Accessed December 2025] [5] European Parliament. 2025. Europe’s Beating Cancer Plan: Implementation findings. https://www.europarl.europa.eu/RegData/etudes/STUD/2025/765809/EPRS_STU(2025)765809_EN.pdf [Accessed December 2025] [6] Hofmarcher, T., et al. 2024. Access to Oncology Medicines in EU and OECD Countries (OECD Health Working Papers, No.170). OECD Publishing. Available at: https://www.oecd.org/content/dam/oecd/en/publications/reports/2024/09/access-to-oncology-medicines-in-eu-and-oecd-countries_6cf189fe/c263c014-en.pdf [Accessed December 2025] [7] Manzano, A., et al. 2025. Comparator Report on Cancer in Europe 2025 – Disease Burden, Costs and Access to Medicines and Molecular Diagnostics (IHE). Available at: https://ihe.se/app/uploads/2025/03/IHE-REPORT-2025_2_.pdf [Accessed December 2025] [8] Efpia. [no date]. Europe’s choice. Available at: https://www.efpia.eu/europes-choice/ [Accessed December 2025] [9] OECD. 2024. Prescription Drug Expenditure per Capita. https://data-explorer.oecd.org/vis?lc=en&pg=0&snb=1&vw=tb&df[ds]=dsDisseminateFinalDMZ&df[id]=DSD_SHA%40DF_SHA&df[ag]=OECD.ELS.HD&df[vs]=&pd=2015%2C&dq=.A.EXP_HEALTH.USD_PPP_PS%2BPT_EXP_HLTH._T..HC51%2BHC3.._T…&to[TIME_PERIOD]=false&lb=bt [Accessed December 2025] [10] The White House. 2025. Delivering most favored-nation prescription drug pricing to American patients. Available at: https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients/ [Accessed December 2025] [11] Eleanor Olcott, Haohsiang Ko and William Sandlund. 2025. The relentless rise of China’s Biotechs. Financial Times. Available at: https://www.ft.com/content/c0a1b15b-84ee-4549-85eb-ed3341112ce5 [Accessed December 2025] [12] European Commission, Directorate-General for Communication. 2025. Making Europe a Global Leader in Life Sciences. Available at: https://commission.europa.eu/news-and-media/news/making-europe-global-leader-life-sciences-2025-07-02_en [Accessed December 2025] [13] Financial Times. 2025. How AI is reshaping drug discovery. Available at: https://www.ft.com/content/8c8f3c10-9c26-4e27-bc1a-b7c3defb3d95 [Accessed December 2025] [14] Seedblink. 2025. Europe’s HealthTech investment landscape in 2025: A deep dive. https://seedblink.com/blog/2025-05-30-europes-healthtech-investment-landscape-in-2025-a-deep-dive [15] European Commission. [No date]. Artificial Intelligence in healthcare. Available at: https://health.ec.europa.eu/ehealth-digital-health-and-care/artificial-intelligence-healthcare_en [Accessed December 2025] [16] Codina, O. 2025. Code meets care: 20 European HealthTech startups to watch in 2025 and beyond. EU-Startups. Available at: https://www.eu-startups.com/2025/06/code-meets-care-20-european-healthtech-startups-to-watch-in-2025-and-beyond [Accessed December 2025] [17] Protogiros et al. 2025. Achieving digital transformation in cancer care across Europe: Practical recommendations from the TRANSiTION project. Journal of Cancer Policy. Available at: https://www.sciencedirect.com/science/article/pii/S2213538325000281 [Accessed December 2025] [18] R-Health Consult. [no date]. The case for investing in a healthier future for the European Union. EFPIA. Available at: https://www.efpia.eu/media/xpkbiap5/the-case-for-investing-in-a-healthier-future-for-the-european-union.pdf [Accessed December 2025] [19] Pousette A., Hofmarcher T. 2024.Tackling inequalities in cancer care in the European Union. Available at: https://ihe.se/en/rapport/tackling-inequalities-in-cancer-care-in-the-european-union-2/ [Accessed December 2025] [20] Efpia. 2025. Comparator Report Cancer in Europe 2025. Available at: https://www.efpia.eu/media/0fbdi3hh/infographic-comparator-report-cancer-in-europe.pdf [Accessed December 2025] [21] Garau, E. et al. 2025. The Transformative Value of Cancer Medicines in Europe. Dolon Ltd. Available at: https://dolon.com/wp-content/uploads/2025/09/EOP_Investment-Value-of-Oncology-Medicines-White-Paper_2025-09-19-vF.pdf?x16809 [Accessed December 2025] [22] IQVIA. 2025. EFPIA Patients W.A.I.T. Indicator 2024 Survey. Available at: https://www.efpia.eu/media/oeganukm/efpia-patients-wait-indicator-2024-final-110425.pdf [Accessed December 2025] [23] Visentin M. 2025. Improving equitable access to medicines in Europe must remain a priority. The Parliament. Available at: https://www.theparliamentmagazine.eu/partner/article/improving-equitable-access-to-medicines-in-europe-must-remain-a-priority [Accessed December 2025] [24] Hofmarcher, T. et al. 2025. Access to novel cancer medicines in Europe: inequities across countries and their drivers. ESMO Open. Available at: https://www.esmoopen.com/action/showPdf?pii=S2059-7029%2825%2901679-5 [Accessed December 2025]

This article is presented by EFPIA with the support of AbbVie I made a trip back to Europe recently, where I spent the vast majority of my pharmaceutical career, to share my perspectives on competitiveness at the European Health Summit. Now that I work in a role responsible for supporting patient access to medicine globally, I view Europe, and how it compares internationally, through a new lens, and I have been reflecting further on why the choices made today will have such a critical impact on where medicines are developed tomorrow. Today, many patients around the world benefit from medicines built on European science and breakthroughs of the last 20 years. Europeans, like me, can be proud of this contribution. As I look forward, my concern is that we may not be able to make the same claim in the next 20 years. It’s clear that Europe has a choice. Investing in sustainable medicines growth and other enabling policies will, I believe, bring significant benefits. Not doing so risks diminishing global influence. > Today, many patients around the world benefit from medicines built on European > science and breakthroughs of the last 20 years I reflect on three important points: 1) investment in healthcare benefits individuals, healthcare and society, but the scale of this benefit remains underappreciated; 2) connected to this, the underpinning science for future innovation is increasingly happening elsewhere; and 3) this means the choices we make today must address both of these trends. First, let’s use the example of migraine. As I have heard a patient say, “Migraine will not kill you but neither [will they] let you live.”[1] Individuals can face being under a migraine attack for more than half of every month, unable to leave home, maintain a job and engage in society.[2] It is the second biggest cause of disability globally and the first among young women.[3] It affects the quality of life of millions of Europeans.[4] From 2011-21 the economic burden of migraine in Europe due to the loss of working days ranged from €35-557 billion, depending on the country, representing 1-2 percent of gross domestic product (GDP).[5]   Overall socioeconomic burden of migraine as percentage of the country’s GDP in 2021 Source: WifOR, The socioeconomic burden of migraine. The case of 6 European Countries.5 Access to effective therapies could radically improve individuals’ lives and their ability to return to work.[6] Yet, despite the staggering economic and personal impacts, in some member states the latest medicines are either not reimbursed or only available after several treatment failures.[7] Imagine if Europe shifted its perspective on these conditions, investing to improve not only health but unlocking the potential for workforce and economic productivity? Moving to my second point, against this backdrop of underinvestment, where are scientific advances now happening in our sector? In recent years it is impressive to see China has become the second-largest drug developer in the world,[8] and within five years it may lead the innovative antibodies therapeutics sector,[9] which is particularly promising for complex areas like oncology. Cancer is projected to become the leading cause of death in Europe by 2035,[10] yet the continent’s share of the number of oncology trials dropped from 41 percent in 2013 to 21 percent in 2023.10 Today, antibody-drug conjugates are bringing new hope in hard-to-treat tumor types,[11] like ovarian,[12] lung[13] and colorectal[14] cancer, and we hope to see more of these advances in the future. Unfortunately, Europe is no longer at the forefront of the development of these innovations. This geographical shift could impact high-quality jobs, the vitality of Europe’s biotech sector and, most importantly, patients’ outcomes. [15] > This is why I encourage choices to be made that clearly signal the value > Europe attaches to medicines This is why I encourage choices to be made that clearly signal the value Europe attaches to medicines. This can be done by removing national cost-containment measures, like clawbacks, that are increasingly eroding the ability of companies to invest in European R&D. To provide a sense of their impact, between 2012 and 2023, clawbacks and price controls reduced manufacturer revenues by over €1.2 billion across five major EU markets, corresponding to a loss of 4.7 percent in countries like Spain.[16] Moreover, we should address health technology assessment approaches in Europe, or mandatory discount policies, which are simply not adequately accounting for the wider societal value of medicines, such as in the migraine example, and promoting a short-term approach to investment. By broadening horizons and choosing a long-term investment strategy for medicines and the life science sector, Europe will not only enable this strategic industry to drive global competitiveness but, more importantly, bring hope to Europeans suffering from health conditions. AbbVie SA/NV – BE-ABBV-250177 (V1.0) – December 2025 -------------------------------------------------------------------------------- [1] The Parliament Magazine, https://www.theparliamentmagazine.eu/partner/article/unmet-medical-needs-and-migraine-assessing-the-added-value-for-patients-and-society, Last accessed December 2025. [2] The Migraine Trust; https://migrainetrust.org/understand-migraine/types-of-migraine/chronic-migraine/, Last accessed December 2025. [3] Steiner TJ, et al; Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137 [4] Coppola G, Brown JD, Mercadante AR, Drakeley S, Sternbach N, Jenkins A, Blakeman KH, Gendolla A. The epidemiology and unmet need of migraine in five european countries: results from the national health and wellness survey. BMC Public Health. 2025 Jan 21;25(1):254. doi: 10.1186/s12889-024-21244-8. [5] WifOR. Calculating the Socioeconomic Burden of Migraine: The Case of 6 European Countries. Available at: [https://www.wifor.com/en/download/the-socioeconomic-burden-of-migraine-the-case-of-6-eu­ropean-countries/?wpdmdl=358249&refresh=687823f915e751752703993]. Accessed June 2025. [6] Seddik AH, Schiener C, Ostwald DA, Schramm S, Huels J, Katsarava Z. Social Impact of Prophylactic Migraine Treatments in Germany: A State-Transition and Open Cohort Approach. Value Health. 2021 Oct;24(10):1446-1453. doi: 10.1016/j.jval.2021.04.1281 [7] Moisset X, Demarquay G, et al., Migraine treatment: Position paper of the French Headache Society. Rev Neurol (Paris). 2024 Dec;180(10):1087-1099. doi: 10.1016/j.neurol.2024.09.008. [8] The Economist, https://www.economist.com/china/2025/11/23/chinese-pharma-is-on-the-cusp-of-going-global, Last accessed December 2025. [9] Crescioli S, Reichert JM. Innovative antibody therapeutic development in China compared with the USA and Europe. Nat Rev Drug Discov. Published online November 7, 2025. [10] Manzano A., Svedman C., Hofmarcher T., Wilking N.. Comparator Report on Cancer in Europe 2025 – Disease Burden, Costs and Access to Medicines and Molecular Diagnostics. EFPIA, 2025. [IHE REPORT 2025:2, page 20] [11] Armstrong GB, Graham H, Cheung A, Montaseri H, Burley GA, Karagiannis SN, Rattray Z. Antibody-drug conjugates as multimodal therapies against hard-to-treat cancers. Adv Drug Deliv Rev. 2025 Sep;224:115648. doi: 10.1016/j.addr.2025.115648. Epub 2025 Jul 11. PMID: 40653109.. [12] Narayana, R.V.L., Gupta, R. Exploring the therapeutic use and outcome of antibody-drug conjugates in ovarian cancer treatment. Oncogene 44, 2343–2356 (2025). https://doi.org/10.1038/s41388-025-03448-3 [13] Coleman, N., Yap, T.A., Heymach, J.V. et al. Antibody-drug conjugates in lung cancer: dawn of a new era?. npj Precis. Onc. 7, 5 (2023). https://doi.org/10.1038/s41698-022-00338-9 [14] Wang Y, Lu K, Xu Y, Xu S, Chu H, Fang X. Antibody-drug conjugates as immuno-oncology agents in colorectal cancer: targets, payloads, and therapeutic synergies. Front Immunol. 2025 Nov 3;16:1678907. doi: 10.3389/fimmu.2025.1678907. PMID: 41256852; PMCID: PMC12620403. [15] EFPIA, Improving EU Clinical Trials: Proposals to Overcome Current Challenges and Strengthen the Ecosystem, efpias-list-of-proposals-clinical-trials-15-apr-2025.pdf, Last accessed December 2025. [16] The EU General Pharmaceutical Legislation & Clawbacks, © Vital Transformation BVBA, 2024.

After more than three decades in the pharmaceutical industry, I know one thing: science transforms lives, but policy determines whether innovation thrives or stalls. That reality shapes outcomes for patients — and for Europe’s competitiveness. Today, Europeans stand at a defining moment. The choices we make now will determine whether Europe remains a global leader in life sciences or we watch that leadership slip away. It’s worth reminding ourselves of the true value of Europe’s life sciences industry and the power we have as a united bloc to protect it as a European good. Europe has an illustrious track record in medical discovery, from the first antibiotics to the discovery of DNA and today’s advanced biologics. Still today, our region remains an engine of medical breakthroughs, powered by an extraordinary ecosystem of innovators in the form of start-ups, small and medium-sized enterprises, academic labs, and university hospitals. This strength benefits patients through access to clinical trials and cutting-edge treatments. It also makes life sciences a strategic pillar of Europe’s economy. The economic stakes Life sciences is not just another industry for Europe. It’s a growth engine, a source of resilience and a driver of scientific sovereignty. The EU is already home to some of the world’s most talented scientists, thriving academic institutions and research clusters, and a social model built on universal access to healthcare. These assets are powerful, yet they only translate into future success if supported by a legislative environment that rewards innovation. > Life sciences is not just another industry for Europe. It’s a growth engine, a > source of resilience and a driver of scientific sovereignty. This is also an industry that supports 2.3 million jobs and contributes over €200 billion to the EU economy each year — more than any other sector. EU pharmaceutical research and development spending grew from €27.8 billion in 2010 to €46.2 billion in 2022, an average annual increase of 4.4 percent. A success story, yes — but one under pressure. While Europe debates, others act Over the past two decades, Europe has lost a quarter of its share of global investment to other regions. This year — for the first time — China overtook both the United States and Europe in the number of new molecules discovered. China has doubled its share of industry sponsored clinical trials, while Europe’s share has halved, leaving 60,000 European patients without the opportunity to participate in trials of the next generation of treatments. Why does this matter? Because every clinical trial site that moves elsewhere means a patient in Europe waits longer for the next treatment — and an ecosystem slowly loses competitiveness. Policy determines whether innovation can take root. The United States and Asia are streamlining regulation, accelerating approvals and attracting capital at unprecedented scale. While Europe debates these matters, others act. A world moving faster And now, global dynamics are shifting in unprecedented ways. The United States’ administration’s renewed push for a Most Favored Nation drug pricing policy — designed to tie domestic prices to the lowest paid in developed markets — combined with the potential removal of long-standing tariff exemptions for medicines exported from Europe, marks a historic turning point. A fundamental reordering of the pharmaceutical landscape is underway. The message is clear: innovation competitiveness is now a geopolitical priority. Europe must treat it as such. A once-in-a-generation reset The timing couldn’t be better. As we speak, Europe is rewriting the pharmaceutical legislation that will define the next 20 years of innovation. This is a rare opportunity, but only if reforms strengthen, rather than weaken, Europe’s ability to compete in life sciences. To lead globally, Europe must make choices and act decisively. A triple A framework — attract, accelerate, access — makes the priorities clear: * Attract global investment by ensuring strong intellectual property protection, predictable regulation and competitive incentives — the foundations of a world-class innovation ecosystem. * Accelerate the path from science to patients. Europe’s regulatory system must match the speed of scientific progress, ensuring that breakthroughs reach patients sooner. * Ensure equitable and timely access for all European patients. No innovation should remain inaccessible because of administrative delays or fragmented decision-making across 27 systems. These priorities reinforce each other, creating a virtuous cycle that strengthens competitiveness, improves health outcomes and drives sustainable growth. > Europe has everything required to shape the future of medicine: world-class > science, exceptional talent, a 500-million-strong market and one of the most > sophisticated pharmaceutical manufacturing bases in the world. Despite flat or declining public investment in new medicines across most member states over the past 20 years, the research-based pharmaceutical industry has stepped up, doubling its contributions to public pharmaceutical expenditure from 12 percent to 24 percent between 2018 and 2023. In effect, we have financed our own innovation. No other sector has done this at such scale. But this model is not sustainable. Pharmaceutical innovation must be treated not as a cost to contain, but as a strategic investment in Europe’s future. The choice before us Europe has everything required to shape the future of medicine: world-class science, exceptional talent, a 500-million-strong market and one of the most sophisticated pharmaceutical manufacturing bases in the world. What we need now is an ambition equal to those assets. If we choose innovation, we secure Europe’s jobs, research and competitiveness — and ensure European patients benefit first from the next generation of medical breakthroughs. A wrong call will be felt for decades. The next chapter for Europe is being written now. Let us choose the path that keeps Europe leading, competing and innovating: for our economies, our societies and, above all, our patients. Choose Europe. -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is European Federation of Pharmaceutical Industries and Associations (EFPIA) * The ultimate controlling entity is European Federation of Pharmaceutical Industries and Associations (EFPIA) * The political advertisement is linked to the Critical Medicines Act. More information here.

Pediatric respiratory diseases are among the most common and serious health challenges we face worldwide. From examples such as respiratory syncytial virus (RSV) to pertussis (also known as whooping cough), these infections can cause significant illness, hospitalizations, and with some, possible long-term consequences.[1],[2] Worldwide, RSV causes approximately 3.6 million hospitalizations and 100,000 deaths each year in children under five years of age.[3] Yet, many of these infections may be prevented, if we continue to prioritize and strengthen immunization. Immunization is not just a scientific achievement; it’s a public health imperative. And in this new era, Sanofi is at the forefront, driving innovation and access to pediatric immunization, especially when it comes to respiratory disease prevention. Our commitment is global, our ambition bold: to help protect people everywhere against preventable illnesses, with the confidence that every child, every parent, every person, and every healthcare professional deserves. > Immunization is not just a scientific achievement; it’s a public health > imperative. RSV, a leading cause of infant hospitalizations globally, exemplifies both the challenge and the opportunity.[4],[5],[6],[7] With an estimated 12.9 million lower respiratory infections and 2.2 million hospitalizations annually among infants under one year of age,3 the burden is immense. For decades, RSV lacked preventive options for the broad infant population. Some countries in Europe are a good illustration of what is possible when prevention is prioritized. For example, in Galicia, Spain, implementation of a universal program offered to the broad infant population led to notable reductions in RSV-related hospitalization compared with previous seasons.[8] The lesson is clear: when prevention is prioritized like it matters, delivered equitably and integrated into routine care, the impact is quickly seen. This principle applies to other childhood respiratory diseases. Hexavalent combination vaccinations have helped to revolutionize pediatric immunization by combining protection against six diseases into one vaccine. One of these is pertussis, which is especially dangerous for children who haven’t received all their vaccinations yet, and have a four-fold higher risk of contracting whooping cough.[9]  For younger infants pertussis is high risk, with over 40 percent of infants under six months of age requiring hospitalization.[10] These data demonstrate how delayed or missed vaccine doses can leave children vulnerable. By combining vaccines into a single shot, immunization uptake can be improved, increasing acceptance with efficient and equitable delivery and helping reduce disease burden at scale.[11],[12] > Some countries in Europe are a good illustration of what is possible when > prevention is prioritized. For example, in Galicia, Spain, implementation of a > universal program offered to the broad infant population led to notable > reductions in RSV-related hospitalization compared with previous seasons. Good uptake is crucial for protecting children. Where programs are fragmented, under-resourced or underfunded, equity gaps worsen along familiar lines – income, access and information. The recent resurgence of some preventable diseases is not just a warning; it’s a call to action.[13],[14],[15] Sustaining protection against respiratory diseases in children, increasing vaccination coverage rates, and embracing innovation to help protect against more diseases must be a collective priority.[11],[12] We must not let misinformation or complacency erode public trust in immunization. The evidence is clear: prevention works. Today, we have a unique opportunity to showcase that impact and redefine the future of respiratory health in children. > We must not let misinformation or complacency erode public trust in > immunization. The evidence is clear: prevention works. The science is sound. The approach for protecting infants against respiratory infections is clear. Our children deserve nothing less. -------------------------------------------------------------------------------- [1] Glaser EL, et al. Impact of Respiratory Syncytial Virus on Child, Caregiver, and Society. Journal of Infectious Diseases. 2022;226(Supplement_2):S236-S241 [2] Kardos P, et al. Understanding the impact of adult pertussis and its complications. Hum Vaccin Immunother. 2024. [3] Li Y, Wang X, Blau DM, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet 2022;399:2047-2064. [4] Leader S, Kohlhase K. Respiratory syncytial virus-coded pediatric hospitalizations, 1997 to 1999. The Pediatric infectious disease journal. 2002;21(7):629-32. [5] McLaurin KK, Farr AM, Wade SW, Diakun DR, Stewart DL. Respiratory syncytial virus hospitalization outcomes and costs of full-term and preterm infants. Journal of Perinatology: official journal of the California Perinatal Association. 2016;36(11):990-6. [6] Rha B, et al. Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016. Pediatrics. 2020;146:e20193611. [7] Arriola CS, et al. Estimated Burden of Community-Onset Respiratory Syncytial Virus-Associated Hospitalizations Among Children Aged <2 Years in the United States, 2014-15. J Pediatric Infect Dis Soc. 2020;9:587-595. [8] Ares-Gómez S, et al. NIRSE-GAL Study Group. Effectiveness and impact of universal prophylaxis with nirsevimab in infants against hospitalisation for respiratory syncytial virus in Galicia, Spain: initial results of a population-based longitudinal study. Lancet Infectious Diseases. 2024; 24: 817-828. [9] Centers for Disease Control and Prevention. 2019 Final Pertussis Surveillance Report. Accessed 4 March 2025 [10] Glanz, J. M., et al. (2013) Association between undervaccination with diphtheria, tetanus toxoids, and acellular pertussis (DTaP) vaccine and risk of pertussis infection in children 3 to 36 months of age. JAMA Pediatr. doi: 10.1001/jamapediatrics.2013.2353 [11] Fatima M, Hong KJ. 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LONDON — American pharmaceutical giants will start to shutter their U.K. operations unless Keir Starmer’s government agrees to pay more for their drugs, U.S. Ambassador to the U.K. Warren Stephens warned ministers on Wednesday. “The U.K. needs to continue addressing its pricing structures for medicines to ensure it can compete for investment from U.S. firms,” Stephens told a U.K.-U.S. business gathering in central London attended by British trade and foreign ministers. “If there are not changes made, and fast, pharma businesses will not only cancel future investments, they will shut down their facilities in the U.K.,” the diplomat said. “This would be a major blow to a country that prides itself, rightly so, on its life sciences sector.”  The U.K. is locked in drug-pricing negotiations with the Trump administration and pharmaceutical firms about how much the National Health Service pays for their products through the so-called Voluntary Scheme for Pricing, Access and Growth (VPAG) scheme. Britain has offered to increase the threshold at which the NHS pays firms for medicines by up to 25 percent, POLITICO first reported in October. But pharmaceutical executives are pushing the government to go further. American drugmaker Eli Lilly’s international business chief said on Monday that it wants to see more changes to Britain’s medicine market before it pivots on its abandoned £279 million investment in a biotech incubator project. “I don’t think we have heard enough to say that we are willing to get the Lilly Gateway Lab started,” Patrik Jonsson, president of Lilly’s international business, which covers all markets outside the U.S., told POLITICO. The focus of talks has turned to the government’s “clawback” system, where firms have to pay back part of their revenue if the total amount the NHS spends on drugs rises above a certain cap. Unless ministers agree to also raise that cap, any extra NHS spending will mean a larger clawback bill for pharma companies. Pricing talks feature in the U.K.’s ongoing trade negotiations with Washington after Starmer struck a framework trade deal with Trump in May, promising to “improve the overall environment” for pharmaceutical firms operating in Britain. U.K. negotiators are currently in Washington and “progress is being made on this literally as we speak,” Stephens said, adding he hopes “that will yield some success.”  The U.K.’s “chief obstacle” to growth is also its high energy costs, Stephens added. “If there are not major reforms to U.K. energy policy, then the U.K.’s position as a premier destination in the global economy is vulnerable.”  Britain’s Labour government is “completely signed up to an ambitious agenda for business,” said Trade Minister Chris Bryant, in an address following Stephens’ speech. He set out how the government plans to “integrate” its industrial, small business and trade strategies to grow the economy.

It could have been the ominous cold open to a classic Bond film. The Russian and Chinese leaders caught on a hot mic at a Beijing military parade, casually musing about cheating death. “With the development of biotechnology, human organs can be continuously transplanted and people can live younger and younger, and even achieve immortality,” Russian leader Vladimir Putin told Chinese ruler Xi Jinping, his tone half clinical, half conspiratorial. “Predictions are that this century, there is a chance of living to 150,” Xi replied. But this wasn’t a scriptwriter’s villainous fantasy. It was a jaw-droppingly real exchange between two of the world’s most powerful, heavily armed leaders. While it may have sounded absurd, behind palace walls, the obsession with longevity is more than idle chatter. The Russian and Chinese leaders were caught on a hot mic at a Beijing military parade, casually musing about cheating death. | Pool photo by Alexander Kazakov/AFP via Getty Images In 2024, the Kremlin ordered scientists to fast-track anti-aging research on cellular degeneration, cognitive decline and the immune system. Meanwhile, China has also been pouring resources into exploring nanotechnology-delivered hydrogen therapy and compounds such as betaine and lithocholic acid, hoping to slow down aging and extend healthy lifespans. But even as the world’s autocrats fantasize about replacing body parts like car tires, the science remains far less accommodating. James Markmann, executive council president at the American Society of Transplant Surgeons, called Xi and Putin’s idea of living to 150 through transplants “unfounded.” “There is currently no evidence suggesting that living to 150 years of age is possible through organ transplantation,” Markmann said. “While there is much interest in related research and some progress in intervening in the aging process, there is no evidence that a 150-year lifespan can currently be achieved.” While organ transplantation can and does save lives, there’s no data that it can also slow or reset an individual’s biological clock, Markmann said. Replacing a single organ, or even several, may improve health temporarily, but it cannot halt the overall aging process of the body. “The concerning idea here is that there is a surplus of organs available that can consistently be replenished for a single individual to prolong their life; this is simply not the case,” Markmann said. THE OLDEST OBSESSION The Xi-Putin exchange didn’t happen in a vacuum. History is littered with rulers who believed they could outsmart death. Qin Shi Huang, China’s first emperor, swallowed mercury pills in pursuit of eternal life, a habit that eventually killed him. Egyptian pharaohs mummified themselves for eternity, Cleopatra dabbled in youth potions and medieval alchemists peddled elixirs. By the 20th century, Russia’s last czar, Nicholas II, and Empress Alexandra were consulting Rasputin and other mystics for advice on health and longevity. Today, the same quest has migrated to Silicon Valley, where the mega-rich pour fortunes into cryonics, anti-aging biotech and “biohacking” in the hope of buying more time. According to Elizabeth Wishnick, an expert on Sino-Russian relations and senior research scientist at the Center for Naval Analyses (CNA), a non-partisan research and analysis organization, this fixation is typical of the world’s wealthiest and most powerful. “They want to go into outer space, they want to go underwater … the human body for them is just another frontier,” she told POLITICO. “It’s logical for people who don’t feel limits to try to extend those boundaries.” But there’s a stark contrast close to home. Life expectancy in Russia remains just over 73 years, while in China, it hovers around 79 years, with access to healthcare being deeply unequal. In Wishnick’s view, Xi and Putin “would do better to focus on that, but instead their focus seems to be on their own longevity, not the health of their societies.” UNFINISHED BUSINESS There’s also a significant cultural dimension agitating Xi and Putin. Robert Jay Lifton, the American scholar who coined the term “symbolic immortality,” argued that humans invent religions, nations and political legacies as ways of cheating death. Xi’s mantra of “national rejuvenation” and Putin’s mission to restore a “great Russia” fit neatly into that framework — even if they can’t physically live forever. “Both of them are really hostage to their own propaganda,” said Wishnick. “They truly believe they are the only leaders who can do the job. They’re concerned about their legacy and how they’ll be remembered in history.” That, she said, helps explain their obsession with reclaiming “lost” territories — Taiwan for Beijing; Ukraine for Moscow — as if completing unfinished maps might also complete their historical destinies. Qin Shi Huang’s attempt at immortality, the Terracotta Army, still stands today. | Forrest Anderson/Getty Images They’ve made creeping moves toward that goal domestically. Xi has upended China’s tradition of leadership turnover to maintain his dominance, while Putin has dismantled elections and eliminated rivals until only he remains. “It’s not surprising they would look to science as a way of extending that,” Wishnick added. While the scientific limitations persist, immortality will — at least for the time being — remain tied to public consciousness and memory. See, for example, Qin Shi Huang’s Terracotta Army, which still stands, or Russia’s expansionist czar, Peter the Great, an 18th-century leader who inspires Putin even today. But even in a world of nanotech and organ swaps, immortality has a catch: you still have to live with yourself. And for the world’s Bond villains, that might be the cruelest sentence of all.

Bill Anderson is the CEO of Bayer. Europe was once the epicenter of progress. After centuries of the Dark Ages, a radical new way of acquiring knowledge — the scientific method — cemented the continent’s place at the apex of civilization. Problem is, that was around 400 years ago. Today, Europe is home to strong research universities and prodigious talent, but it has been losing ground, particularly to the U.S. and China. In the 1990s, for example, half of all new medicines originated in Europe — now, the figure’s down to one in five. And the life sciences is just one of many such industries. Europe must reverse this trend, and now is the time to act. We stand on the precipice of a new world order, with increasing trade uncertainty and multipolarity, and it’s not yet clear how things will shake out. In this period of flux, Europe’s leaders rightly want to elevate science and innovation to the heart of its economy. But for this to become a reality, its member countries need to step up their game in terms of simplifying regulation. Starting a business in Italy or Greece, for example, can take months due to needless hurdles like in-person meetings, notary fees and bank account setups. It’s no wonder that advances in AI are almost exclusively happening in the U.S. and China. The biotech revolution attracts 75 percent of its talent in the U.S. and Asia, and Brazil is at the forefront of agricultural innovation. Meanwhile Europe is all too often sitting on the sidelines, asking “what’s allowed?” rather than “what’s possible?” Here’s the thing: Europe can produce world-changing innovation. In fact, some of today’s pioneering startups, like CRISPR Therapeutics, emerged from Europe. But thanks to a more accommodating regulatory environment, proximity to research hubs and access to venture capital, these companies have expanded heavily in the U.S. This isn’t to say the U.S. is without problems, or that Europe should try to refashion itself into Silicon Valley. In fact, Europe publishes about twice as many scientific articles as the U.S., and is home to multiple research hubs that foster international collaboration. However, we need a distinctly European course correction to once again unleash Europe’s innovative spirit. I am confident that with the right mindset and conditions, this can be done — but not if we continue down the path of business — or rather, bureaucracy — as usual. As last year’s Draghi report on EU competitiveness stated: “The only way to become more productive is for Europe to radically change.” I’ve personally had the rare privilege of working and living in five different European countries, including in Germany for the last two years, as the CEO of Bayer — a 160-year-old life sciences company headquartered in Germany. And we’ve now kicked off the most radical transformation since the company’s founding. Upending decades of tradition is not for the faint of heart, but sometimes it’s essential. And here are a few lessons worth bearing in mind, whether modernizing a company or a continent: Firstly, it’s time to simplify regulations and embrace the new technologies required to solve our biggest challenges, just like the U.S., Canada and other countries have already done. The U.K., for example, passed a bill allowing the development and marketing of gene-edited crops in 2023. As last year’s Draghi report on EU competitiveness stated: “The only way to become more productive is for Europe to radically change.” | Teresa Suarez/EFE via EPA On this front, we welcome the EU’s increased openness toward gene editing in agriculture, which carries tremendous potential to help farmers adapt to climate change. For instance, Italy showed courageous leadership last year, breaking with two decades of policy to allow the first field trial of a gene-edited crop, which scientists developed to improve the rice plant’s resistance to a prevalent fungus. The rest of the continent ought to follow this lead. Next, Europe also needs investment. While innovation in Europe has grown, prices for pharmaceuticals have decreased. And why is it that one of the most advanced continents, with a market of 450 million people, is seen less and less as a place to invest for developing the drugs of tomorrow? We need to change that. Everyone deserves reliable and affordable access to medicines, and everyone has a role to play. Investing in research and development (R&D) is the beating heart of the life sciences — and it comes at an enormous financial cost: More than 90 percent of pharmaceutical research ends in failure. But without R&D, our industry would be dead on arrival and have little to offer patients. So, it’s time for Europe to step up and view paying fair prices for new pharmaceutical innovation as an investment in the future — not just another cost to be minimized. At Bayer, we operate in a new model called “dynamic shared ownership,” where employees enjoy the autonomy to make decisions, share resources and direct their focus toward the biggest priorities. And we’re seeing the model pay off already, with rapid growth in our pharmaceuticals business — together, our two biggest launch medicines have grown 80 percent in sales year over year, and one is now a blockbuster. The truth is, the expat scientists who come to Europe won’t have an easy time translating their discoveries into impactful products and therapies without systemic changes. Supporting scientists also requires robust IP protection, a speedier regulatory framework and a better environment for high-risk, high-reward investors. Any innovative life sciences company in Europe would welcome these dramatic changes to the status quo. And as the world’s economic order shifts, it’s Europe’s turn to level the playing field. In 50 years, will we look back on 2025 as the moment our continent rose to the challenge and opened its arms to the future? Will we celebrate the biotech hub of Berlin as we now do Boston, with scientists flocking there to start companies, test cures for diseases and develop tools to help farmers feed the world? Or will we utter a collective sigh, pondering what could have been? It’s time to decide.

Imagine a Europe at the cutting-edge of research, development and manufacturing. Where patients have access to the latest vaccines and treatments, first. A Europe with confidence in its resilience, health and economic security. The General Pharmaceutical Legislation (GPL) is one important step in realizing that vision. Get it right and we can begin to rebuild Europe’s life science eco-system. Get it wrong, and we risk accelerating the loss of research, development and manufacturing to other regions of the world.  It’s hard to miss the irony that almost nine months from Mario Draghi urging Europe to catch up with other regions by implementing a coordinated industrial policy or face a ‘slow agony’, our industry is nervously anticipating decisions that could, at best, maintain the same incentives framework that has seen our share of global investment decline over the last 20 years. The GPL offers some hope to up Europe’s game with a future-proof regulatory framework and new tools to tackle antimicrobial resistance. This does not sound like the recipe for European success … yet. Fierce competition from the US and China Whatever the geopolitical situation today, Draghi’s conclusions echoed numerous warnings highlighting Europe’s decades-long decline in life sciences. Since the legislation was last addressed in 2004, Europe has lost a quarter of its share of global R&D investment. And its share of global trials has halved, resulting in 60,000 fewer clinical trial places available for Europeans. Concurrently, spending on pharmaceutical R&D in China has grown almost five times faster than in Europe. China has doubled its number of commercial clinical trials since 2018; it now accounts for 18 percent of the global share. Their recent adoption of a proposal to introduce Regulatory Data Protection (RDP) signals China’s efforts to attract investment in R&D for innovative medicines. A step likely to be even more effective if Europe were to move in the opposite direction. Just 30 years ago, one in two new medicines originated in Europe, now it is just one in five. This is hardly a surprise given that the US went from spending €2bn more than Europe to spending €25bn more today over the same period. > Just 30 years ago, one in two new medicines originated in Europe, now it is > just one in five. Proposals to shape the future Since the framework was first introduced over 20 years ago, science has taken giant leaps forward. We are in a golden era of innovation, with much more to come. Immunotherapies empower the body to attack and destroy cancer cells, HIV can be managed, Hep C can be cured, and there is a good chance that cervical cancer could be eradicated thanks to the HPV vaccination. From prevention to care to cure, medicine is evolving rapidly. We strongly welcome, support and need the proposals to future proof the regulatory approval system. The regulatory sandbox is a big step in helping bring future breakthrough innovations of today and tomorrow to EU patients. Meanwhile, the proposal to use electronic-only patient information for medicinal products directly administered by healthcare professionals will reduce the administrative burden. > We strongly welcome, support and need the proposals to future proof the > regulatory approval system. Addressing another health emergency Similarly, since the legal framework was last addressed there has been widespread recognition that antimicrobial resistance represents one of the world’s most pressing health emergencies. Yet despite the urgent need, private investment in antimicrobial R&D is limited. To prevent bacteria developing resistance to existing treatments, the aim with any new antibiotic is to use it as little as possible — not an attractive proposition for investors. Included as a proposal in the GPL, the transferable exclusivity voucher is designed to address this challenge by rewarding the discovery of novel antibiotics without requiring upfront public investment. The GPL provides an opportunity for Europe to take the lead in delivering new antibiotics. Not only would this bring considerable cost-savings to every member state, it would also significantly boost R&D efforts in antibiotics, putting European researchers at its center. Proposals that accelerate negative trends In the context of recent shifts in US policy, trade tensions, concerns over national security, supply chain resilience, increasing levels of protectionism and the drive to address Europe’s competitiveness crisis, the initial proposals to erode European intellectual property (IP) in life sciences are now completely out of step. It takes two to launch a new medicine Many of the decisions that impact when patients get access to a new medicine are outside a company’s control, in fact, two-thirds of the delays to access medicines occur after companies have filed for pricing and reimbursement. For example, in Greece, companies can only file for reimbursement once a medicine is reimbursed in at least five of 11 designated EU countries, delaying filing due to the external reference pricing system. This structural condition adds to other delays, including those linked to limited healthcare funding and launch decisions. As a consequence, measures like obligating companies to launch in all 27 member states will completely fail to address inequalities in access to medicines while proving to be highly damaging to the sector’s presence in the EU. The proposal to reduce the Regulatory Data Protection (RDP) and Orphan Market Exclusivity would have a similar impact; the US already leads Europe on every investor metric from availability of capital to speed of approval and rewards for innovation. RDP for small molecules is the only appreciable benefit that the EU has over the US. The proposed expansion of the Bolar exemption — a legal provision that permits the narrow use of a patented medicine to support a generic’s marketing authorization application before IP expiration — would further erode Europe’s IP framework. It would likely lead to more litigation, reduce legal certainty and predictability, and negatively impact patients, including potentially introducing co-payment. Instead, the EU should create a clear notification system to give both generic and innovative companies transparent, reliable ‘day one’ certainty and safeguard IP protection. “If Europe truly wants to have research, development and manufacturing in the region, as well as delivering the best care for its citizens, it has to align the outcomes of discussions on the GPL with its ambition to be a world leader in medical innovation, maintain resilient supply chains and compete economically.” Nathalie Moll, director general, EFPIA. High stakes, high risk The stakes are high, and the risks tangible and immediate — but so are the opportunities. In recent weeks, global pharmaceutical companies, some of them headquartered in Europe, have announced hundreds of billions of dollars in investment into US manufacturing. This is likely just the beginning. > The stakes are high, and the risks tangible and immediate — but so are the > opportunities. A survey of 18 EFPIA members in April this year identified as much as 85 percent of capital expenditure investments (around €50.6 billion) and as much as 50 percent of R&D expenditure (around €52.6 billion) as being potentially at risk. Over the next three months alone, surveyed companies estimated that a total of €16.5 billion, or 10 percent of the total investment plans, are at risk. From intent to action There have been important positive statements of intent, reflected in the announcement of the Biotech Act, Life Sciences Strategy and Competitiveness Compass. Turning this intent into rapid and radical policy change will help, and the first tangible and visible signal will be the operating environment for companies in Europe created by the GPL. Investors and innovators are watching closely to see which side the GPL lands on.

Life expectancy in the European Union has risen to its highest level ever recorded, according to figures released by Eurostat on Friday. According to data collected in 2023, the average lifetime expected in the EU now is 81.4 years, marking an overall increase of 3.8 years since the start of data recording in 2002.  However, the figures show a stark divide between the western and eastern parts of Europe, as most people born west of the former Iron Curtain can expect to live more than 80 years, while some regions on the eastern edge of the bloc lag behind with life expectancies of around 75 years.  Regions with the highest expected life span are the Spanish capital Madrid with 86.1 years, followed by the northern Italian region of Trento and the Åland Islands between Sweden and Finland with 85.1 years.  On the other hand, Bulgaria’s northwestern region had the lowest life expectancy, at 73.9 years, followed by Hungary’s northeastern counties and the EU’s outermost region, the French Mayotte islands off the coast of Madagascar, at 74.9 years. But several other regions in Bulgaria, Romania and Hungary, as well as Latvia, also lag behind Southern Europeans in life expectancy by almost 10 years — perhaps making a case for the Mediterranean diet, even if some say it’s dead. Another glaring divide seems to be a gender gap, with women expected to live 5 years longer than men. The gender gap appears to be widest in the Baltic States, as women in Latvia are expected to live 10 years longer than men, followed by Lithuania with 9 years and Estonia with 8.8 years. The smallest gender gap is in the Netherlands, at 3 years.

Over the past couple of years there has been a growing focus on PFAS (per- and poly-fluoroalkyl substances) — a group of more than 10,000 synthetic chemicals that are widely used in consumer and industrial products. Their chemical stability and resistance to oil and water has made them incredibly useful across many industries, including the pharmaceutical sector, where they are critical to medicines and medical devices, manufacturing and packaging. Following a joint REACH restriction proposal by five EU member states in 2023, this broad group of chemicals has been under the spotlight due to environment and health concerns, potentially concluding in a widespread ban on all PFAS by 2027. The research-based pharmaceutical industry supports regulating PFAS of concern, substituting them or minimizing their use while protecting patients’ access to medicines. > The research-based pharmaceutical industry supports regulating PFAS of > concern, substituting them or minimizing their use while protecting patients’ > access to medicines. There is also broad consensus within the pharmaceutical sector that environmental legislation is important in mitigating environmental impacts and climate change, and companies are working on numerous initiatives to achieve this. €50 million project launched Our industry is actively searching for alternatives. As part of the Innovative Health Initiative (IHI) — a public-private partnership initiative for health research and innovation between the EU and Europe’s life science industries — a call was launched for a project on PFAS exposure, emissions and end-of-life management in the health care sector.  The initiative will see at least €48 million — half of which are in-kind contributions from the industry and half EU funding for public partners — committed to explore which PFAS are currently used in the pharma and medtech sectors, identify opportunities to phase out PFAS of concern and find alternatives that maintain at least the same level of patient safety and product performance. From the industry side, the initiative is led by Belgian based pharma company, UCB, and involving 26 pharmaceutical and medtech companies. Further proposal considerations will look at the improved usage of PFAS materials and minimize environmental exposure, map the types and applications of PFAS throughout the supply chain, and develop a database of alternatives. The call is open until April, 23 for consortia to apply for the funding. Large companies that would like to contribute in-kind and join the existing industry consortium should contact EFPIA. via EFPIA The IHI call is important. Currently no evidence exists of technically suitable and readily available alternatives that can substitute PFAS active pharmaceutical ingredients (APIs). No single ‘drop in’ replacement exists, given that each API is not only treating a certain medical condition, but also has individual properties like efficacy, side-effects, incompatibilities and drug interactions. Understanding PFAS and its uses in medicines PFAS is a broad non-specific term relating to thousands of molecules. Not all PFAS present the same risks to the environment or health. The industry relies on certain PFAS for safe manufacturing, distribution and use of medicinal products. Packaging, drug application devices and processing machinery, or items to extend a medicine’s shelf life or protect sterility, are just a few examples of what would fall under a blanket ban. For example, high-performance fluoropolymers — especially polychlorotrifluoroethylene and ethylene tetrafluoroethylene — are vital to the containment, storage and delivery of injectable medicinal products. They help to form protective barriers, ensuring quality and safety and preventing degradation and deterioration. They also facilitate sterilization according to required Good Manufacturing Practices standards of fully coated stoppers due to the smooth hard surface. The unique properties of fluoropolymers provide resistance to biological, chemical and physical degradation. The impact on medicines and vaccines development It is with this in mind that the industry is urging caution on a blanket ban on PFAS. Without a derogation for medicines, 98% of the market authorizations of new medicines would need to be amended, which in turn could see around 70% of critical medicines in EU member states at risk of short supply. An EFPIA survey of 40 pharmaceutical companies found that at least 93% of APIs manufacturing relies on PFAS. via EFPIA If the ban applies as proposed, a wide range of medicines will become in short supply or unavailable, with impact on patient health anticipated both within and outside of the European Economic Area (EEA). Manufacturing and product development will have to be relocated outside of the EEA, impacting the economy and strategic autonomy of Europe. Additionally, banning PFAS within the EU while importing PFAS-containing products from elsewhere would be inconsistent and undermine the policy’s credibility. via EFPIA Protecting patient care is a joint responsibility. While European lawmakers will need to make difficult decisions, changes to environmental legislation need to work for Europe and for all patients while being realistically deliverable over the long and short term. > If the ban applies as proposed, a wide range of medicines will become in short > supply or unavailable, with impact on patient health anticipated both within > and outside of the European Economic Area. The way forward Our industry wants to see legislation that is proportionate, effective and safe with a transitional period of time-limited or unlimited derogations for low risk PFAS while protecting patients’ access to medicines. There is currently no like-for-like replacement for PFAS, and making changes to medicines in this highly regulated sector requires new approvals. Any alternatives must be analyzed for their superior environmental performance and must not compromise patient safety. When a viable and scalable alternative is identified, implementation will require time and collaboration among partners in the value chain — including regulators, as any changes in manufacturing necessitate new regulatory approvals. To make a regulation fit for purpose, EFPIA is proposing three recommendations: 1. Time limited derogations until suitable alternative solutions are commonly agreed and qualified. 2. The development of partnerships throughout supply chains to better manage PFAS emissions. 3. Global health authorities expedite approvals of suitable fluorine-free alternatives. Pharmaceutical companies are among the most active in the world in developing policies to mitigate climate change and improve public health. They often aim higher than the compliance targets set within the various EU legislative requirements as part of the EU Green Deal initiatives, including under the zero pollution, circular economy and climate action plans. From the climate emergency to clean water, there are projects underway to minimize the environmental impacts of our supply chain, manufacturing and products. As the EU navigates the complexities of PFAS regulation, we must champion policies that simultaneously uphold environmental goals and ensure uninterrupted access to medicines.