Faced with an ageing population and rising chronic disease rates, Europe wants to make its citizens healthier. It also needs to keep its most powerful industries happy. In the basket of health policies that EU lawmakers rushed to get across the line before Christmas, industry was the big winner: The pharmaceutical, food and drink sectors walked away with a set of major policy wins — and (potentially) healthier profits. While the pharma industry previously feared losing some of its monopoly rights on new drugs, the Commission this month offered it an extra year of patent protection for novel biotech drugs — among the most expensive treatments in the world. The food and drink sectors, meanwhile, successfully pushed back against proposals to tax ultra-processed foods and alcopops, for now. On Dec. 16 the Commission published its Biotech Act and Safe Hearts Plan, which landed just days after a long-awaited update of the pharmaceutical legislation. Taken together, they seek to incentivize industries to innovate and do business in Europe, improve access to medicines, and tackle the burden of cardiovascular disease. The pharma industry broadly celebrated the biotech proposal. The Biotech Act “reflects priorities we’ve intensively advocated to keep Europe globally competitive in life sciences,” Ognjenka Manojlovic, head of policy at European pharmaceutical company Sanofi, told POLITICO. That includes accelerating clinical trials, boosting intellectual property, and strengthening financing for Europe’s biotech ecosystem, Manojlovic said. The pharmaceutical sector had pushed for longer monopoly rights in the pharma legislation. In the end they were kept at the current standard eight years — instead of being cut by two years as the European Commission had initially proposed. For Europe’s public health insurers, who pay for drugs, the decisions taken to maintain and then extend market protections for medicines are hard to square. “We are puzzled by the Commission’s intentions,” said Yannis Natsis, director of the European Social Insurance Platform, a network of Europe’s social insurance organizations, warning that taxpayers will have to pick up the bill. Meanwhile, health campaigners are also unhappy at the Commission’s “missed opportunity” to tackle obesity and heart disease with junk food taxes — as proposed in an earlier draft of the Safe Hearts Plan. Samuele Tonello, at consumer organization BEUC, said the Safe Hearts Plan “lacks teeth” to better protect consumers from unhealthy foods, and flagged the “urgency of [cardiovascular diseases].”  A MAN ON A MISSION Health Commissioner Olivér Várhelyi has made no secret of his support for industry, and has championed the Commission’s competitiveness mantra since taking office in late 2024. Health Commissioner Olivér Várhelyi has made no secret of his support for industry, and has championed the Commission’s competitiveness mantra since taking office in late 2024. | Thierry Monasse/Getty Images The standout feature of his end-of-year bonanza was the 12-month patent extension in the Biotech Act I — legislation that was split in two late in the day, allowing Várhelyi to meet his end-of-year deadline for the pharma component. The proposal came just a week after the Commission, countries and MEPs clinched a deal to reform Europe’s pharmaceutical laws, in which IP rights were among the last issues to be settled. Updates to the pharma laws were a legacy of the last Commission, whereas the Biotech Act became something of a personal mission for Várhelyi. He repeatedly stressed that there was “no time to lose” in delivering a targeted policy aimed at revitalizing Europe’s flagging biotech industry, which risks being overtaken by competition from China and the U.S. Few commissioners are more vocal than Várhelyi about the premium they place on the competitiveness of European industry.  Industry insiders had heard whispers of his plans to expand IP incentives for the biotech sector, even if Council representatives were dismayed not to have been informed in advance — especially with the ink barely dry on the Pharma Package. That’s not to say pharma is happy with its lot. Industry lobby group the European Federation of Pharmaceutical Industries and Associations (EFPIA) tempered its praise of the Biotech Act, lamenting that the extra year of monopoly rights would only apply to a “limited subset of products.”  The extra year of protection is tied to the Commission’s efforts to locate more pharma research and manufacturing in Europe. It would apply only to new products, tested and at least partially made in Europe.  But the generics sector, which makes cheaper, off-patent drugs to compete with branded medicines, sees the Biotech Act as a further sweetening of what is already one of the world’s most generous IP systems. Lobby group Medicines for Europe claims each year of delayed competition for the top three biologic drugs would cost countries €7.7 billion. Longer IP “will have a dramatic impact on healthcare budgets and delayed patients’ access to essential medicines,” said Adrian van den Hoven, head of the lobby. These kinds of estimates would normally be included in an impact assessment published alongside the proposal, but in its haste to get the Biotech Act out the Commission didn’t do one. POLITICO asked the Commission for an estimate of what the extra year of patent protection would cost. A Commission spokesperson would not give a figure but said they had used the impact assessment for the pharma legislation as a reference. “It is also important to stress that the number of products eligible for an additional year of SPC will be limited to only those that are truly innovative and tested and manufactured in the EU. The approach is deliberately targeted to incentivise genuinely innovative therapies that deliver a clear added value for patients and support European innovation,” the spokesperson said. LUCKY ESCAPE FOR UPFS The big food and drink sectors are on shakier ground with Várhelyi. The commissioner has repeatedly made known his distaste for ultra-processed food, and an early leaked version of the Safe Hearts Plan included new taxes on unhealthy highly processed foods and alcopops. But the final proposal showed the Commission had undertaken a significant climbdown. Concrete targets to tax unhealthy food and drink in 2026 were gone, replaced with a much woollier commitment to “work towards” such a levy. Alcopops were excluded altogether.  Industry lobby FoodDrinkEurope took a far more measured tone on the final plan than its explosive reactions to the earlier leaks, but that may well ramp up again if and when health tax proposals emerge. The text suggests the soft drinks industry may be the Commission’s first target if it does decide to pursue new levies, while UPFs remain in Várhelyi’s sights. “In the next couple of years, we will need to tackle the issue of ultra-processed food much more,” he told MEPs in December. For now, though, the plan seems to have let industry off easy. Health NGOs saw it as a disappointment, given its lack of hard-hitting policies to reduce consumption of UPFs and other unhealthy products. While the pharma legislation is all wrapped up, the Biotech Act still needs to win the approval of EU countries and the European Parliament. For the food and pharma sectors, the proposals set out this month are confirmation they have allies in the Berlaymont.

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]

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.

BRUSSELS — Europe needs to get its “act together” and unleash its potential in the pharmaceutical sector, supporting it with better incentives and ensuring access to innovation for patients, urged Stefan Oelrich, president of Bayer’s pharmaceuticals division. “Europe used to be the pharmacy of the world. Nine out of 10 new medicines were discovered in Europe. That’s no longer the case,” Oelrich, who is also president of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said at the POLITICO 28 Gala Dinner. “We’re losing competitiveness rather than gaining.” China and the U.S. are pulling ahead on pharmaceutical innovation and clinical trials. About one third of medicines approved by the U.S. Food and Drug Administration (FDA) don’t make it to Europe, Oelrich said. And amid the U.S. tariffs threat, companies are increasingly looking outside of Europe for investments. But there is hope — both for the pharmaceutical industry and beyond. Per Franzén, CEO and managing partner at EQT, a global investment organization, said he is seeing “an unprecedented interest to invest into Europe.” “It’s a real window of opportunity, a unique moment in time for Europe,” he said. “In order to make the most out of that opportunity, what we need to do is really to drive a more business-friendly, more innovation-friendly agenda,” he said. But with the pace of change, driven by artificial intelligence, “time is of the essence,” he added. Over-regulation isn’t holding Europe back in medicines innovation, it’s a lack of substantial incentives for companies to invest in Europe, Oelrich said. But it doesn’t have to be this way, he said: “We have some of the best universities in the world that publish some of the coolest science in the world. So there is no reason why this wouldn’t work. And we need to get our act together,” he said. “Instead of trying to complicate our lives and come up with a new bureaucratic idea, we should come up with with ways of how we unleash our forces.”

BRUSSELS — EU lawmakers have clinched a long-awaited agreement on the bloc’s overhaul of its two decades-old pharmaceutical rules — one of the EU’s biggest health files. The revamp is designed to restore Europe’s competitive edge and give companies more certainty that the EU remains an attractive market, while also pushing for more equal access to medicines across member countries. The deal between the Parliament and the Council was struck at 5 a.m. on Thursday, more than two years after the Commission tabled the proposal, which consists of directive and regulation, in spring 2023.  It marks a major victory for the Danish presidency, which pledged to wrap up the file before the end of the year, and for Health Commissioner Olivér Várhelyi, who has pushed to seal the reform amid growing geopolitical uncertainty.

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.

Lobbyists for some of the world’s largest drug companies are parading a new pricing deal in the U.K. as a model the rest of Europe should emulate if it wants to keep drugmakers from bailing for America. To President Donald Trump and the lobbyists’ delight, British officials agreed to spend 25 percent more on new medicines in exchange for three years of tariff relief on pharmaceutical exports to the U.S. The move comes as major drugmakers like AstraZeneca and Merck scrap projects in the U.K., and the Trump administration uses tariff threats to get pharma to raise prices on Europeans in order to cut them for Americans. For Washington’s lobbyists, the deal reflects the new influence playbook, as Trump’s tariff threats force companies to negotiate directly with the White House. Industry leaders say the U.K. deal could serve as a template for how the EU and other major trade partners handle the Trump administration’s break from free market norms, and stay competitive. “The U.K. is the canary in the coal mine,” said Stephen Farrelly, global head of pharma and health care at ING, a Dutch bank. “The pressure is rising on the EU to do something similar.” Lobbyists for drug companies are pounding the point home. Dorothee Brakmann, general manager of Pharma Deutschland, Germany’s industry lobby, warned that if Germany did not pursue a similar path to the U.K., Trump’s tariffs presented a “real geopolitical risk.” “The UK-US agreement is an important signal for Europe’s pharmaceutical landscape. …[It] reinforces the need to reassess how we can make our own reimbursement system more flexible, more innovation-friendly and more internationally competitive,” she wrote POLITICO in a statement. Alex Schriver, senior vice president of public affairs at the Pharmaceutical Research and Manufacturers of America, the U.S. industry lobby for brand-name drugmakers, echoed the German pharma group’s call for similar country deals. “The agreement establishes important first steps by the U.K. to pay its fair share for innovative medicines and directly benefits American patients by exempting medicines from tariffs. We encourage the Trump Administration to seek similar agreements with other nations,” Schriver said in a statement. Henrik Jeimke-Karge, spokesperson for Verband Forschender Arzneimittelhersteller, another German pharmaceutical group, said that the lack of an EU agreement meant continued uncertainty for the region. “The pharmaceutical industry in the U.K. has now gained planning security. Such an agreement is still pending for the EU. …The risk of customs duties remains high and uncertainty persists,” he said in a statement. Trump has repeatedly blamed European pharmaceutical companies for higher U.S. drug prices, threatened a 100 percent tariff on pharmaceutical products and demanded drugmakers implement “most favored nation pricing,” which would bring U.S. prices in line with those paid in other wealthy nations. The threats have triggered British and European drugmakers to bolster their defenses on K Street, Washington’s lobbying corridor. Lobbying spending from July to September from GSK, AstraZeneca, Novartis, NovoNordisk, and Genentech, a subsidiary of Roche, were the highest for the time period in at least a decade. Year-to-date spending from AstraZeneca, EMD Serono, Novo Nordisk and Sanofi are also at a 10-year high. European drugmakers are also ramping up their hiring of outside lobbying firms. DLA Piper, Corcoran & Associates, and B Hall Strategies registered to lobby for Novartis this year, which hired no new outside firms last year. Lobbyists for Novartis now include Richard Burr, the former top Republican on the Senate Health, Education, Labor and Pensions Committee and Michael Corcoran, a prominent Republican lobbyist from Florida. Alkermes and Novo Nordisk have hired Ballard Partners, a Trump-connected lobbying firm, and Genentech has hired lobbyists at Miller Strategies, including Jeff Miller, a long-time Republican strategist and Ashley Gunn, a former special assistant to Trump in his first term. GSK, Sanofi and Novo Nordisk, meanwhile, have all hired lobbyists at Checkmate Government Relations this year, including Fritz Vaughan, a Treasury official in the first Trump administration. “Policy is not siloed from business strategy right now,” said Allison Parker-Lagoo, deputy of the North America health practice at APCO, a public and government relations firm that advises drug companies. “The geopolitical environment is just requiring that everyone really think critically about how they’re showing up in each market that they operate in.” In exchange for tariff reprieve, five drugmakers, including AstraZeneca, EMD Serono and Novo Nordisk have cut deals with Trump to lower prices. The pharmaceutical industry has together announced more than $400 billion in commitments to U.S. manufacturing, research and development since January, according to ING, the Dutch bank, including a $50 billion commitment from Roche, $23 billion from Novartis, and $20 billion from Sanofi. “Trump is demonstrating that he’s willing to go further than anyone else to achieve his goals…Most companies and industries are having a conversation saying, ‘Let’s bring some solutions to the table,’ as opposed to just sitting back and holding the line,” said one health care lobbyist granted anonymity to speak candidly about strategy. “It’s a big shift, and you don’t want to be the last one to the dance,” the lobbyist added. Concerns over Europe’s pharmaceutical competitiveness were mounting prior to Trump’s second term. E.U. spending on research and development grew on average 4.4 percent annually from 2010 to 2022, while U.S. spending grew by 5.5 percent and China by more than 20 percent, according to the European Federation of Pharmaceutical Industries and Associations, the EU’s pharmaceutical trade group, which did not respond to request for comment. Last year, the U.S. saw $6.7 billion in pharmaceutical manufacturing investments from foreign companies, compared to $5.9 billion in Europe, according to estimates from fDi Markets, a database owned by the Financial Times. Advocates for drug companies warned that the Trump administration’s pricing and tariff policies will accelerate the shift. “It speaks to the reorienting of the global biopharmaceutical economy…For the first time, the U.S. government is getting involved in the pricing and access behaviors of other countries,” said Kirsten Axelsen, a senior policy adviser at DLA Piper, a law and lobbying firm. “[Companies] are advocating…to avoid the types of policies that would really make it almost impossible to launch a drug in European countries.”

LONDON — Britain’s biggest drugmaker says it will only give the greenlight to plans for a £200 million Cambridge research site if ministers go further on NHS spending reforms in their trade negotiations with the United States. The U.K. has drawn up proposals to increase the amount the state-funded National Health Service is allowed to pay pharmaceutical firms for drugs after intense discussions with officials from the Trump administration. But AstraZeneca CEO Pascal Soriot is pushing for a bigger increase to the threshold that determines how much the NHS can spend on new medicines — the benchmark used by NICE to judge whether a treatment is worth the cost. “I will invest where I believe my products are going to be used,” said Soriot in a call with reporters on Thursday, responding to questions about the Cambridge site. “Otherwise, you do trials that lead to nothing, and it’s a frustration for physicians, for patients, and for us.”  AstraZeneca paused plans for the £200 million Cambridge research center in September.  Ministers have proposed a 25 percent boost to the NHS’s drug-pricing threshold as part of ongoing negotiations with the Trump administration around looming pharmaceutical tariffs. The U.S. Ambassador to the U.K. Warren Stephens warned British ministers on Wednesday that American pharmaceutical giants will start to shutter their U.K. operations unless Keir Starmer’s government agrees to pay more for their drugs. AstraZeneca’s Soriot, who struck a three-year tariff relief deal with the Trump administration last month, wants to push the NHS spending threshold higher so that it can buy drugs costing £40,000-£50,000 per year of healthy life gained, up from around £20,000-£30,000 today.  “This number has not been adjusted for more than 20 years, so we would need to see a substantial adjustment based on the amount of inflation that has taken place, and that’s the only way to improve access for patients,” he said.  Soriot also said the government would need to substantially adjust its “clawback” system — known as the Voluntary Scheme for Pricing, Access and Growth (VPAG) — where firms have to pay back part of their revenue if NHS spending on drugs exceeds a cap.  “If you get a better price  […] but then you get a big rebate later on, it really doesn’t help either,” he said.  But AstraZeneca CEO Pascal Soriot is pushing for a bigger increase to the threshold that determines how much the NHS can spend on new medicines. | Pool photo by Shawn Thew/EPA Without these changes, Soriot warned pharmaceutical investment will continue flowing elsewhere, including to the U.S. and China. If things “continued to deteriorate the way they do […] it’s actually possible” that the U.K. may become a country down the line that may only have access to generics and no innovation, he said.  As British officials seek to negotiate a solution with their U.S. counterparts in Washington this week, ahead of the U.K. budget on Nov. 26, Soriot argued that higher spending now would pay off in the long run. “Every government has financial constraints, of course, but that’s why I’m saying that those changes will only apply to new products, and the impact on budgets would come over time,” he said, adding that “in the meantime, it would generate investment from pharmaceutical companies.”