Thirty-six million Europeans — including more than one million in the Nordics[1] — live with a rare disease.[2] For patients and their families, this is not just a medical challenge; it is a human rights issue. Diagnostic delays mean years of worsening health and needless suffering. Where treatments exist, access is far from guaranteed. Meanwhile, breakthroughs in genomics, AI and targeted therapies are transforming what is possible in health care. But without streamlined systems, innovations risk piling up at the gates of regulators, leaving patients waiting. Even the Nordics, which have some of the strongest health systems in the world, struggle to provide fair and consistent access for rare-disease patients. Expectations should be higher. THE BURDEN OF DELAY The toll of rare diseases is profound. People living with them report health-related quality-of-life scores 32 percent lower than those without. Economically, the annual cost per patient in Europe — including caregivers — is around €121,900.[3] > Across Europe, the average time for diagnosis is six to eight years, and > patients continue to face long waits and uneven access to medications. In Sweden, the figure is slightly lower at €118,000, but this is still six times higher than for patients without a rare disease. Most of this burden (65 percent) is direct medical costs, although non-medical expenses and lost productivity also weigh heavily. Caregivers, for instance, lose almost 10 times more work hours than peers supporting patients without a rare disease.[4] This burden can be reduced. European patients with access to an approved medicine face average annual costs of €107,000.[5] Yet delays remain the norm. Across Europe, the average time for diagnosis is six to eight years, and patients continue to face long waits and uneven access to medications. With health innovation accelerating, each new therapy risks compounding inequity unless access pathways are modernized. PROGRESS AND REMAINING BARRIERS Patients today have a better chance than ever of receiving a diagnosis — and in some cases, life-changing therapies. The Nordics in particular are leaders in integrated research and clinical models, building world-class diagnostics and centers of excellence. > Without reform, patients risk being left behind. But advances are not reaching everyone who needs them. Systemic barriers persist: * Disparities across Europe: Less than 10 percent of rare-disease patients have access to an approved treatment.[6] According to the Patients W.A.I.T. Indicator (2025), there are stark differences in access to new orphan medicines (or drugs that target rare diseases).[7] Of the 66 orphan medicines approved between 2020 and 2023, the average number available across Europe was 28. Among the Nordics, only Denmark exceeded this with 34. * Fragmented decision-making: Lengthy health technology assessments, regional variation and shifting political priorities often delay or restrict access. Across Europe, patients wait a median of 531 days from marketing authorization to actual availability. For many orphan drugs, the wait is even longer. In some countries, such as Norway and Poland, reimbursement decisions take more than two years, leaving patients without treatment while the burden of disease grows.[8] * Funding gaps: Despite more therapies on the market and greater technology to develop them, orphan medicines account for just 6.6 percent of pharmaceutical budgets and 1.2 percent of health budgets in Europe. Nordic countries — Sweden, Norway and Finland — spend a smaller share than peers such as France or Belgium. This reflects policy choices, not financial capacity.[9] If Europe struggles with access today, it risks being overwhelmed tomorrow. Rare-disease patients — already facing some of the longest delays — cannot afford for systems to fall farther behind. EASING THE BOTTLENECKS Policymakers, clinicians and patient advocates across the Nordics agree: the science is moving faster than the systems built to deliver it. Without reform, patients risk being left behind just as innovation is finally catching up to their needs. So what’s required? * Governance and reforms: Across the Nordics, rare-disease policy remains fragmented and time-limited. National strategies often expire before implementation, and responsibilities are divided among ministries, agencies and regional authorities. Experts stress that governments must move beyond pilot projects to create permanent frameworks — with ring-fenced funding, transparent accountability and clear leadership within ministries of health — to ensure sustained progress. * Patient organizations: Patient groups remain a driving force behind awareness, diagnosis and access, yet most operate on short-term or volunteer-based funding. Advocates argue that stable, structural support — including inclusion in formal policy processes and predictable financing — is critical to ensure patient perspectives shape decision-making on access, research and care pathways. * Health care pathways: Ann Nordgren, chair of the Rare Disease Fund and professor at Karolinska Institutet, notes that although Sweden has built a strong foundation — including Centers for Rare Diseases, Advanced Therapy (ATMP) and Precision Medicine Centers, and membership in all European Reference Networks — front-line capacity remains underfunded. “Government and hospital managements are not providing  resources to enable health care professionals to work hands-on with diagnostics, care and education,” she explains. “This is a big problem.” She adds that comprehensive rare-disease centers, where paid patient representatives collaborate directly with clinicians and researchers, would help bridge the gap between care and lived experience. * Research and diagnostics: Nordgren also points to the need for better long-term investment in genomic medicine and data infrastructure. Sweden is a leader in diagnostics through Genomic Medicine Sweden and SciLifeLab, but funding for advanced genomic testing, especially for adults, remains limited. “Many rare diseases still lack sufficient funding for basic and translational research,” she says, leading to delays in identifying genetic causes and developing targeted therapies. She argues for a national health care data platform integrating electronic records, omics (biological) data and patient-reported outcomes — built with semantic standards such as openEHR and SNOMED CT — to enable secure sharing, AI-driven discovery and patient access to their own data DELIVERING BREAKTHROUGHS Breakthroughs are coming. The question is whether Europe will be ready to deliver them equitably and at speed, or whether patients will continue to wait while therapies sit on the shelf. There is reason for optimism. The Nordic region has the talent, infrastructure and tradition of fairness to set the European benchmark on rare-disease care. But leadership requires urgency, and collaboration across the EU will be essential to ensure solutions are shared and implemented across borders. The need for action is clear: * Establish long-term governance and funding for rare-disease infrastructure. * Provide stable, structural support for patient organizations. * Create clearer, better-coordinated care pathways. * Invest more in research, diagnostics and equitable access to innovative treatments. Early access is not only fair — it is cost-saving. Patients treated earlier incur lower indirect and non-medical costs over time.[10] Inaction, by contrast, compounds the burden for patients, families and health systems alike. Science will forge ahead. The task now is to sustain momentum and reform systems so that no rare-disease patient in the Nordics, or anywhere in Europe, is left waiting. -------------------------------------------------------------------------------- [1] https://nordicrarediseasesummit.org/wp-content/uploads/2025/02/25.02-Nordic-Roadmap-for-Rare-Diseases.pdf [2] https://nordicrarediseasesummit.org/wp-content/uploads/2025/02/25.02-Nordic-Roadmap-for-Rare-Diseases.pdf [3] https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf [4] https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf [5] https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf [6] https://www.theparliamentmagazine.eu/partner/article/a-competitive-and-innovationled-europe-starts-with-rare-diseases? [7] https://www.iqvia.com/-/media/iqvia/pdfs/library/publications/efpia-patients-wait-indicator-2024.pdf [8] https://www.iqvia.com/-/media/iqvia/pdfs/library/publications/efpia-patients-wait-indicator-2024.pdf [9] https://copenhageneconomics.com/wp-content/uploads/2025/09/Copenhagen-Economics_Spending-on-OMPs-across-Europe.pdf [10] https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Alexion Pharmaceuticals * The entity ultimately controlling the sponsor: AstraZeneca plc * The political advertisement is linked to policy advocacy around rare disease governance, funding, and equitable access to diagnosis and treatment across Europe More information here.

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.

Rick Pazdur, the FDA’s top drug regulator, told staff Tuesday he submitted his resignation to the agency, an abrupt departure weeks after he was convinced by Commissioner Marty Makary to take the post to help bring stability to an agency reeling from months of upheaval, according to four people familiar with the decision granted anonymity to discuss the move. The decision — which comes days after top vaccine regulator Vinay Prasad said the agency would ratchet up regulatory requirements for new vaccines — is almost certain to raise new questions about Makary’s leadership of the FDA. Pazdur in recent weeks clashed with Makary over the Commissioner’s National Priority Voucher program, according to media reports. That program — which aims to speed final review of drugs that address health priorities, pose a transformative innovative impact, address an unmet medical need, help onshoring efforts or increase affordability — was also criticized by Pazdur’s predecessor, George Tidmarsh. FDA experts have worried the involvement of political appointees in the process of choosing which firms receive a voucher could raise questions about the program’s integrity. STAT first reported the news of Pazdur’s decision to retire. It is unclear if the decision is final — one person familiar with the decision said the longtime cancer drug regulator has 30 days to change his decision. “We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” an FDA spokesperson said in a statement. “As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients. His leadership, vision, and dedication will continue to shape the FDA for years to come.” The White House and Pazdur did not immediately respond to requests for comment. Pazdur, a 26-year agency veteran, initially rebuffed efforts by Makary to convince him to assume leadership of the FDA’s Center for Drug Evaluation and Research — but ultimately agreed to take the job after being assured he would be given autonomy in the role free from political influence and the ability to rehire staff.

LONDON — The U.K. has agreed to raise how much its National Health Service spends on new drugs, in a concession made under pressure from the Trump administration in return for tariff-free access to the U.S. market. “Today’s agreement is a major win for American workers and our innovation economy,” U.S. Commerce Secretary Howard Lutnick said in a statement on Monday. “This deal doesn’t just deepen our economic partnership with the United Kingdom — it ensures that the breakthroughs of tomorrow will be built, tested, and produced on American soil.”  The deal will see Britain increase the National Institute for Health and Care Excellence (NICE) cost-effectiveness threshold by 25 percent, as POLITICO first reported in October, and slash the cap on revenue the NHS can reclaim from drugmakers to no more than 15 percent.  The new NICE threshold will be £25,000 to £35,000 per quality adjusted life year gained over and above current treatments. The U.S. said the combined changes would increase the net price the NHS pays for new medicines by 25 percent. In exchange, the administration will grant an exemption for U.K.-made pharmaceuticals, ingredients and medical technology from U.S. tariffs for the remainder of President Donald Trump’s term.  U.K. Business and Trade Secretary Peter Kyle said: “This deal guarantees that UK pharmaceutical exports – worth at least £5 billion a year – will enter the US tariff free, protecting jobs, boosting investment and paving the way for the UK to become a global hub for life sciences. “We will continue to build on the UK-US Economic Prosperity Deal, and the record-breaking investments we secured during the US State Visit, to create jobs and raise living standards as part of our Plan for Change.” The breakthrough comes after months of back-and-forth between both sides, with the sector not covered in the Economic Prosperity Deal and Washington demanding a “preferential environment” to lift the threat of steep import duties. The administration had threatened to impose up to 100 percent tariffs on drugs.  In July, the President issued a letter to 17 drugmakers, demanding they offer their drugs to Medicaid at most-favored-nation prices, prices tied to lower prices abroad, and shift manufacturing to U.S. soil.  Update: This story has been updated following confirmation from the U.S. and U.K. governments.

As Europe redefines its life sciences and biotech agenda, one truth stands out: the strength of our innovation lies in its interconnection between human and animal health, science and society, and policy and practice. This spirit of collaboration guided the recent “Innovation for Animal Health: Advancing Europe’s Life Sciences Agenda” policy breakfast in Brussels, where leading voices from EU politics, science and industry came together to discuss how Europe can turn its scientific excellence into a truly competitive and connected life sciences ecosystem. Jeannette Ferran Astorga / Via Zoetis Europe’s role in life sciences will depend on its ability to see innovation holistically. At Zoetis we firmly believe that animal health innovation must be part of that equation, as this strengthens resilience, drives sustainability, and connects directly to the wellbeing of people. Innovation without barriers Some of humanity’s greatest challenges continue to emerge at the intersection of human, animal and environmental health, sometimes with severe economic impact. The recent outbreaks of diseases like avian influenza, African swine fever and bluetongue virus act as reminders of this. By enhancing the health and welfare of animals, the animal health industry and veterinarians are strengthening farmers’ livelihoods, supporting thriving communities and safeguarding global food security. This is also contributing to protecting wildlife and ecosystems. Meanwhile, companion animals are members of approximately half of European households. Here, we have seen how dogs and cats have become part of the family, with owners now investing a lot more to keep their pets healthy and able to live to an old age. Because of the deepening bonds with our pets and their increased longevity, the demand for new treatment alternatives is rising continuously, stimulating new research and innovative solutions making their way into veterinary practices. Zoonotic diseases that can be transferred between animals and humans, like rabies, Lyme disease, Covid-19 and constantly new emerging infectious diseases, make the rapid development of veterinary solutions a necessity. Throughout the world, life sciences are an engine of growth and a foundation of health, resilience and sustainability. Europe’s next chapter in this field will also be written by those who can bridge human and animal health, transforming science into solutions that deliver both economic and societal value. The same breakthroughs that protect our pets and livestock underpin the EU’s ambitions on antimicrobial resistance, food security and sustainable agriculture. Ensuring these innovations can reach the market efficiently is therefore not a niche issue, it is central to Europe’s strategic growth and competitiveness. This was echoed at the policy event by Dr. Wiebke Jansen, Policy Lead at the Federation of Veterinarians of Europe (FVE) when she noted that ‘innovation is not abstract. As soon as a product is available, it changes the lives of animals, their veterinarians and the communities we serve. With the many unmet needs we still face in animal health, having access to new innovation is an extremely relevant question from the veterinary perspective.’ Enabling innovation through smart regulation To realize the promise of Europe’s life sciences and biotech agenda, the EU must ensure that regulation keeps pace with scientific discovery. The European Commission’s Omnibus Simplification Package offers a valuable opportunity to create a more innovation-friendly environment, one where time and resources can be focused on developing solutions for animal and human health, not on navigating overlapping reporting requirements or dealing with an ever increasing regulatory burden. > In animal health, biotechnology is already transforming what’s possible — for > example, monoclonal antibodies that help control certain chronic conditions or > diseases with unprecedented precision. Reviewing legislative frameworks, developing the Union Product Database as a true one-stop hub or introducing digital tools such as electronic product information (e-leaflets) in all member states, for instance, would help scientists and regulators alike to work more efficiently, thereby enhancing the availability of animal health solutions. This is not about loosening standards; it is about creating the right conditions for innovation to thrive responsibly and efficiently. Science that serves society Europe’s leadership in life sciences depends on its ability to turn cutting-edge research into real-world impact, for example through bringing new products to patients faster. In animal health, biotechnology is already transforming what’s possible — for example, monoclonal antibodies that help control certain chronic conditions or diseases with unprecedented precision. Relieving itching caused by atopic dermatitis or alleviating the pain associated with osteoarthritis significantly increases the quality of life of cats and dogs — and their owners. In addition, diagnostics and next-generation vaccines prevent outbreaks before they start or spread further. Maintaining a proportionate, benefit–risk for veterinary medicines allows innovation to progress safely while ensuring accelerated access to new treatments. Supporting science-based decision-making and investing in the European Medicines Agency’s capacity to deliver efficient, predictable processes will help Europe remain a trusted partner in global health innovation. Continuum of Care / Via Zoetis A One Health vision for the next decade Europe is not short of ambition. The EU Biotech Act and the Life Sciences Strategy both aim to turn innovation into a driver of growth and wellbeing. But to truly unlock their potential, they must include animal health in their vision. The experience of the veterinary medicines sector shows that innovation does not stop at species’ borders; advances in immunology, monoclonal antibodies and the use of artificial intelligence benefit both animals and humans. A One Health perspective, where veterinary and human health research reinforce each other, will help Europe to play a positive role in an increasingly competitive global landscape. The next five years will be decisive. By fostering proportionate, science-based adaptive regulation, investing in digital and institutional capacity, and embracing a One Health approach to innovation, Europe can become a genuine world leader in life sciences — for people and the animals that are essential to our lives. -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Zoetis Belgium S.A. * The political advertisement is linked to policy advocacy on the EU End-of-Life Vehicles Regulation (ELVR), circular plastics, chemical recycling, and industrial competitiveness in Europe. More information here.

With multiple legislative processes underway, we are now in an important moment for Europe’s ambition to boost access and be a global leader in innovation. An agile, modernized regulatory system — coupled with supportive intellectual property and access policies — can attract research and development and advanced manufacturing to Europe. This will contribute to the earlier availability of new cures for European patients and a healthier innovative ecosystem. Unfortunately, today we see that Europe is falling behind global competition. Over the last decade, there has been a 10 percent decrease in clinical trials in the European Union, which has led to 60,000 fewer European patients participating in trials.[1] Europe’s fragmented system for clinical trial approvals is a leading cause of this decline, impacting early access to innovative treatments. As scientific breakthroughs can deliver better health outcomes for patients, governments need to keep pace with this speed of innovation. > Draghi report on EU competitiveness importantly identified pharmaceutical > innovation as a strategic sector for growth in Europe. That said, the report > also noted that what is missing is a simple and strong execution plan behind > it, with simplified regulation and coherent and predictable policies that > could drive the European goals of increased competitiveness and strategic > autonomy. Europe’s marketing authorisation process now exceeds 14 months (444 days), causing patients to wait nearly three months longer than in the US (356 days) and over five months longer than in Japan (290 days) for access to innovative medicines.[2] Such delays, combined with complex and lengthy country-level market access systems, mean patients in Europe are waiting an average of 20 months longer than people living in the United States to benefit from scientific innovation.[3] Last year’s Draghi report on EU competitiveness importantly identified pharmaceutical innovation as a strategic sector for growth in Europe. That said, the report also noted that what is missing is a simple and strong execution plan behind it, with simplified regulation and coherent and predictable policies that could drive the European goals of increased competitiveness and strategic autonomy. Ongoing discussions on the revision of the General Pharmaceutical Legislation and the In Vitro Diagnostic Regulation (IVDR), the Critical Medicines Act and the upcoming Biotech Act (Part 1) mark crucial opportunities for Europe to become a global leader for innovation. However, to make this vision a reality, the EU must address structural challenges that undermine innovation and patient access to novel, lifesaving medicines. > To reverse the worrying decline in European clinical trial activity, the EU > should implement a maximum two-month approval process for clinical trial > applications (CTAs), encompassing the reviews of both regulators and ethics > committees consistent with other global leaders. The successful implementation of structural, future-proof policy changes can ensure timely access to innovative medicines for EU citizens, and this can be achieved through five key policy recommendations: Facilitate and accelerate clinical trial applications To reverse the worrying decline in European clinical trial activity, the EU should implement a maximum two-month approval process for clinical trial applications (CTAs), encompassing the reviews of both regulators and ethics committees consistent with other global leaders. It is equally important to increase collaboration among EU member states to remove unique and specific national CTA requirements and questions, and to also introduce opportunities for an informal dialogue with regulators to expediently address smaller challenges that can be quickly fixed. Legislative overlaps and fragmentation between the Clinical Trials Regulation (CTR) and the IVDR should also be addressed to avoid delays in clinical trials that utilize companion diagnostics. Expand expedited pathways Despite their potential, the EU’s expedited pathways (such as the European Medicines Agency’s PRIME scheme for unmet medical needs, Conditional Marketing Authorisation and Accelerated Assessment) are underutilised, limiting rapid patient access to important medicines. Similar expedited pathways are widely used by other regulators around the world, like the United States and Japan. Expanding the use of expedited pathways in the EU to new indications and aligning eligibility criteria with global standards would ensure that the EU has more competitive regulatory pathways and earlier patient access to life-saving medicines. Shorten scientific advice and approval timelines Shortening the EU’s scientific advice procedure is critical to optimise the development of innovative products, ensure timely and efficient resource management for both applicants and regulators, and maintain the EU’s influence in global scientific and clinical research. By evolving to a more integrated and agile dialogue, the EU can provide comprehensive, consistent guidance throughout the product lifecycle and remain competitive with other regions. Given their growing number, scientific advice should be available for medicines used with all types of medical devices and in vitro diagnostics (including combinations diagnostics) to address the complexities of working across these regulatory frameworks. > An agile, modernized regulatory system — coupled with supportive intellectual > property and access policies — can attract research and development and > advanced manufacturing to Europe. Regarding the current lengthy approval times, the proposed reduction of EMA’s standard assessment timelines from 210 to 180 days — as suggested in the revision of the pharmaceutical legislation — would allow regulators to accelerate their scientific assessments. Furthermore, the European Commission can streamline its decision phase (currently requiring up to 67 days) by conducting its activities in parallel with the scientific assessment. Strengthen the EU Medicines Regulatory Network and embrace regulatory sandboxes Achieving greater speed and agility within a regulatory system requires an appropriately resourced, sustainable regulatory infrastructure. We support transparent regulatory budgets across the network, backed by consistent investments in expertise, funding and infrastructure to support continuous capacity and capability advancements. Collaborative regulatory pathways (such as the EMA OPEN framework) could be further expanded to encourage simultaneous approvals and supply chain resilience across geographies. Additionally, regulatory sandboxes would be beneficial to pilot and adapt frameworks for disruptive future innovations, while ensuring appropriate guardrails to enable the safe development and implementation of these innovations. Enhance patient engagement Effective regulatory decision-making requires both inclusivity and adaptability. Limited patient and expert input can hinder effective regulatory decision-making, while rapid pharmaceutical innovation requires adaptable frameworks. Expert and patient perspectives are crucial for informed benefit-risk and clinical meaningfulness determinations. Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Eli Lilly & Company * The advertisement is linked to General Pharmaceutical Legislation (GPL), In Vitro Diagnostic Regulation (IVDR), Critical Medicines Act (CMA), Biotech Act (Part 1), Clinical Trials Regulation (CTR), EU Medicines Regulatory Network More information here. -------------------------------------------------------------------------------- [1] IQVIA, Assessing the clinical trial ecosystem in Europe, Final Report, October 2024: efpia_ve_iqvia_assessing-the-clinical-trial-ct-ecosystem.pdf. [2] Lara J, Kermad A, Bujar M, McAuslane N. 2025. R&D Briefing 101: New drug approvals in six major authorities 2015-2024: Trends in an evolving regulatory landscape. Centre for Innovation in Regulatory Science. London, UK: https://cirsci.org/wp-content/uploads/dlm_uploads/2025/08/CIRS-RD-Briefing-101-v1.1.pdf. [3] The Patients W.A.I.T. Indicator 2024 Survey. https://www.efpia.eu/media/oeganukm/efpia-patients-wait-indicator-2024-final-110425.pdf

LONDON — Britain’s Department of Health is pressing ahead with plans to open up a trove of pandemic-era patient data to outside researchers — despite concerns from doctors’ representatives. A formal direction titled “GP Data for Consented Research,” yet to be signed by Health Secretary Wes Streeting but shared in draft format with doctors’ reps, would enable NHS England to disseminate patient data originally collected solely for the purpose of Covid-19-related research to other studies. The Department of Health and Social Care (DHSC) confirmed to POLITICO that the direction has been drafted and is awaiting Streeting’s signature. A group of doctors has warned the government that the move could erode patient trust. While the direction says government will obtain patient consent to share the data more broadly, doctors groups are worried this won’t happen in practice, and that patients won’t be aware their data is being funneled to other studies. NHS England has been in discussions with the Joint GP IT Committee, which comprises representatives from the British Medical Association (BMA) and Royal College of General Practitioners (RCGP), about the data, a person close to the talks told POLITICO. DHSC confirmed it had been in dialogue with the doctors’ groups, and a spokesperson said it had delayed signing the direction in order to engage with doctors’ concerns. The JGPITC argued it hasn’t been properly consulted on the change in line with established governance processes, and that repurposing the dataset without asking patients’ permission risks damaging already-fragile public confidence in the profession, the same person said.  While the direction says government will obtain patient consent to share the data more broadly, doctors groups are worried this won’t happen in practice, and that patients won’t be aware their data is being funneled to other studies. | Pool photo by Hannah McKay/EPA It comes after the same group of doctors filed a formal complaint to the Information Commissioner’s Office in June alleging that NHS England had breached data protection law by training a general-purpose AI model on the same dataset without consent. The disagreement is also set against the wider backdrop of a long-running dispute between government and the BMA over doctors’ pay and working conditions. DHSC maintains that proper processes have been followed. “As the Secretary of State made clear last year during his speech to the Royal College of GPs in October 2024, we are committed to implementing this direction in line with patients’ explicit consent for their data to be used in research,” a DHSC spokesperson said. ‘CONSULTED EXTENSIVELY’ In his speech last month, Streeting said he would direct NHS England to take responsibility for sharing patient data with projects including UK Biobank, Genomics England and Our Future Health. “I know there are issues we need to work through together around information governance, risk and liabilities,” he said. “There’s also, let’s be honest, some producer interest in play.” NHS England asked the JGPITC to confirm whether it was happy with the direction on broadening access to the dataset by Nov. 4. The JGPITC couldn’t reach a consensus to give its blessing to the change, the same person close to the talks and cited above said. The doctors’ group has pushed for NHS England to notify consenting participants about where their data is going via text or the NHS App, they added. DHSC is not obligated to comply with any of the JGPITC’s requests. “We have consulted extensively with GP representatives over the past 18 months to ensure patients’ wishes are respected and their data used appropriately, while minimizing the burden on busy GPs,” DHSC’s spokesperson said.

As trilogue discussions on the Critical Medicines Act (CMA) approach, its potential effects on medicine supply, patient access and Europe’s competitiveness are increasingly in focus. From an industry standpoint, several considerations are central to understanding how this act can best achieve its objectives and support a robust pharmaceutical ecosystem in Europe.  Keeping the CMA focused where it matters  Much of the debate around the CMA has centered on its promises to strengthen the availability and security of supply of critical medicines in the EU while improving accessibility to other medicines. These are goals that our industry fully supports.   The European Commission’s proposal is designed to focus on critical medicines, with a vulnerability assessment foreseen to identify which products are truly at risk of disruption and tailor solutions accordingly. Alongside critical medicines, the proposal also introduces a new definition of ‘medicinal products of common interest’. Under current wording, this would include any medicine unavailable in at least three member states, regardless of the underlying reason.   Such a broad definition risks turning a targeted framework for resilience into an all-encompassing mechanism covering almost every medicine on the market, blurring the distinction between supply and access challenges. These are fundamentally different issues that require fundamentally different policy tools.   > Applying the CMA’s tools across the entire medicines market would dilute > priorities, stretch healthcare budgets and create administrative burdens for > industry without delivering real benefits for patients.   The act will be far more effective if it remains focused on where the risks are greatest — in other words, by limiting the ‘medicinal products of common interest’ definition to cases of demonstrable market failure and directing measures toward genuinely critical medicines with a proven risk of supply disruption.  Fixing supply and access hurdles needs more than joint procurement   The CMA places joint procurement at the center of its strategy to address both supply and access challenges. While this approach can contribute to improving availability in certain circumstances, joint procurement will only deliver lasting results if it is designed to address the underlying causes of access delays and shortages, which vary across geographies and products.  For medicines where the main challenge lies in fragile supply chains, joint procurement can play a role, particularly when it enhances predictability and economic viability for suppliers. Experience from the Covid-19 pandemic has shown that coordinated purchasing can be effective in targeted situations. For medicines facing access delays, joint procurement could help improve availability in countries where genuine market failures exist. However, the value of joint procurement for countries where products are already available, or where access barriers can be better addressed by improving national pricing and reimbursement systems, is very questionable.  To ensure that joint procurement does not hinder access, several safeguards are essential. Tenders should reward quality and promote innovation, recognizing the value that innovative medicines bring to patients and society. Price confidentiality must be protected to prevent unintended spillovers, such as reference pricing effects. Once joint procurement agreements are concluded, to ensure commercial and supply predictability there should be no additional national renegotiations or expenditure control measures. Finally, allowing national procurement processes to run in parallel will be key to avoid delays and maintain flexibility.  Beyond these design safeguards, real progress will depend on tackling the broader root causes of shortages and access delays. For supply fragility, this means, among other actions, reducing strategic dependencies where necessary, improving transparency across supply chains and avoiding rigid national stockpiling rules. For access delays, progress will require addressing national pricing and reimbursement challenges, and a greater willingness from governments to reward the value that innovative medicines deliver.  Protectionism won’t make Europe stronger  Few elements of the CMA debate have attracted as much attention as the idea of prioritizing EU-made medicines. The rationale is straightforward: producing more within Europe is expected to reduce reliance on third countries, reinforce strategic autonomy and, ultimately, improve supply security. While this narrative is understandable, taking it at face value risks overlooking the realities of how medicines are manufactured and supplied today.  Europe already has one of the world’s strongest pharmaceutical manufacturing footprints and, unlike some other pharma manufacturing regions, Europe exports 71 percent of its pharmaceutical production. This output depends on global supply networks for active substances, raw materials and specialized technologies. Introducing local-content requirements or preferential treatment for EU-made products would disrupt those networks, fragment supply chains and drive up costs, with limited evidence that such measures would enhance resilience. Local-content requirements could also affect Europe’s trade relationships and weaken, rather than strengthen, its industrial base in the long term, while distorting competition within the single market and undermining the competitiveness of both European and international companies operating in Europe. The likely outcome would be less diversity and greater concentration in supply chains: the opposite of what a resilient system requires.  If procurement criteria referencing resilience or strategic autonomy are used, they should be proportionate and tied to clearly demonstrated dependencies or supply risks. Protectionist approaches, however well-intentioned, cannot substitute for the broader policy environment needed to keep Europe attractive for investment in research and development and manufacturing. A competitive European ecosystem depends first and foremost on predictable intellectual-property rules, timely regulatory processes, access to capital, and a strong scientific and technical skills base.  The EU institutions still have time to steer the CMA on course  The CMA offers a real chance to get things right. The European Parliament’s proposal for more consistent contingency stock rules could help if it stays focused on medicines genuinely at risk of shortage. The act can also make reporting more efficient by using existing systems rather than creating new ones. Policymakers should also be aware that wider regulatory initiatives directly affect Europe’s ability to manufacture and supply medicines. A more coherent policy framework will be essential to strengthen resilience.  Europe’s goal must be to build an environment where pharmaceutical innovation and production can thrive. Europe’s choice is clear: supply security cannot be achieved by weakening the industry that ensures it. The CMA will only work if it tackles the right problems with the right tools and keeps competitiveness at its core.   > Europe’s goal must be to build an environment where pharmaceutical innovation > and production can thrive. Our industry remains ready to engage with EU and national policymakers to make that happen. A high-level forum on the CMA involving all stakeholders could help guide the act’s implementation in a way that improves supply security and speeds up access for patients, while reinforcing Europe’s position as a global player in life sciences.  Disclaimer POLITICAL ADVERTISEMENT * The sponsor is European Federation of Pharmaceutical Industries and Associations (EFPIA) * The political advertisement is linked to the Critical Medicines Act More information here.