Biotechnology is central to modern medicine and Europe’s long-term competitiveness. From cancer and cardiovascular disease to rare conditions, it is driving transformative advances for patients across Europe and beyond . 1         Yet innovation in Europe is increasingly shaped by regulatory fragmentation, procedural complexity and uneven implementation across  m ember s tates. As scientific progress accelerates, policy frameworks must evolve in parallel, supporting the full lifecycle of innovation from research and clinical development to manufacturing and patient access.  The proposed EU Biotech Act seeks to address these challenges. By streamlining regulatory procedures, strengthening coordination  and supporting scale-up and manufacturing, it aims to reinforce Europe’s position in a highly competitive global biotechnology landscape .2       Its success, however, will depend less on ambition than on delivery. Consistent implementation, proportionate oversight and continued global openness will determine whether the  a ct translates into faster patient access, sustained investment and long-term resilience.  Q: Why is biotechnology increasingly seen as a strategic pillar for Europe’s competitiveness, resilience and long-term growth?  Gilles Marrache, SVP and regional general manager, Europe, Latin America, Middle East, Africa and Canada, Amgen:  Biotechnology sits at the intersection of health, industrial policy and economic competitiveness. The sector is one of Europe’s strongest strategic assets and a leading contributor to  research and development  growth . 3    At the same time, Europe’s position is under increasing pressure. Over the past two decades, the EU has lost approximately 25  percent of its global share of pharmaceutical investment to other regions, such as the  United States  and China.   The choices made today will shape Europe’s long-term strength in the sector, influencing not only competitiveness and growth, but also how quickly patients can benefit from new treatments.  > Europe stands at a pivotal moment in biotechnology. Our life sciences legacy > is strong, but maintaining global competitiveness requires evolution .” 4   > >  Gilles Marrache, SVP and regional general manager, Europe, Latin America, > Middle East, Africa and Canada, Amgen. Q: What does the EU Biotech Act aim to do  and why is it considered an important step forward for patients and Europe’s innovation ecosystem?  Marrache: The EU Biotech Act represents a timely opportunity to better support biotechnology products from the laboratory to the market. By streamlining medicines’ pathways and improving conditions for scale-up and investment, it can help strengthen Europe’s innovation ecosystem and accelerate patient access to breakthrough therapies. These measures will help anchor biotechnology as a strategic priority for Europe’s future  —  and one that can deliver earlier patient benefit  —  so long as we can make it work in practice.  Q: How does the EU Biotech Act address regulatory fragmentation, and where will effective delivery and coordination be most decisive? Marrache: Regulatory fragmentation has long challenged biotechnology development in Europe, particularly for multinational clinical trials and innovative products. The Biotech Act introduces faster, more coordinated trials, expanded regulatory sandboxes and new investment and industrial capacity instruments.   The proposed EU Health Biotechnology Support Network and a  u nion-level regulatory status repository would strengthen transparency and predictability. Together, these measures would support earlier regulatory dialogue, help de-risk development   and promote more consistent implementation across  m ember  s tates.   They also create an opportunity to address complexities surrounding combination products  —  spanning medicines, devices and diagnostics  —  where overlapping requirements and parallel assessments have added delays.5 This builds on related efforts, such as the COMBINE programme,6 which seeks to streamline the navigation of the In Vitro Diagnostic Regulation , 7 Clinical Trials Regulation8 and the Medical Device Regulation9 through a single, coordinated assessment process. Continued clarity and coordination will be essential to reduce duplication and accelerate development timelines .10 Q: What conditions will be most critical to support biotech scale-up, manufacturing  and long-term investment in Europe?  Marrache: Europe must strike the right balance between strategic autonomy and openness to global collaboration. Any new instruments under the Biotech Act mechanisms should remain open and supportive of all types of biotech investments, recogni z ing that biotech manufacturing operates through globally integrated and highly speciali z ed value chains.   Q: How can Europe ensure faster and more predictable pathways from scientific discovery to patient access, while maintaining high standards of safety and quality?   Marrache: Faster and more predictable patient access depends on strengthening end-to-end pathways across the lifecycle.  The Biotech Act will help ensure continuity of scientific and regulatory experti z e, from clinical development through post-authori z ation. It will also support stronger alignment with downstream processes, such as health technology assessments, which  are  critical to success.   Moreover, reducing unnecessary delays or duplication in approval processes can set clearer expectations, more predictable development timelines and earlier planning for scale-up.    Gilles Marrache, SVP and regional general manager, Europe, Latin America, Middle East, Africa and Canada, Amgen. Via Amgen. Finally, embedding a limited number of practical tools (procedural, digital or governance-based) and ensuring they are integrated within existing  European Medicines Agency and EU regulatory structures can help achieve faster patient access . 11 Q: What role can stronger regulatory coordination, data use and public - private collaboration play in strengthening Europe’s global position in biotechnology?  Marrache: To unlock biotechnology’s full potential, consistent implementation is essential. Fragmented approaches to secondary data use, divergent  m ember   state interpretations and uncertainty for data holders still limit access to high-quality datasets at scale. The Biotech Act introduces key building blocks to address this.   These include Biotechnology Data Quality Accelerators to improve interoperability, trusted testing environments for advanced innovation, and alignment with the EU AI Act ,12  European Health Data Space13 and wider EU data initiatives. It also foresees AI-specific provisions and clinical trial guidance to provide greater operational clarity.  Crucially, these structures must simplify rather than add further layers of complexity.   Addressing remaining barriers will reduce legal uncertainty for AI deployment, support innovation and strengthen Europe’s competitiveness.  > These reforms will create a moderni z ed biotech ecosystem, healthier > societies, sustainable healthcare systems and faster patient access to the > latest breakthroughs in Europe .” 14 > > Gilles Marrache, SVP and regional general manager, Europe, Latin America, > Middle East, Africa and Canada, Amgen.  Q: As technologies evolve and global competition intensifies, how can policymakers ensure the Biotech Act remains flexible and future-proof?  Marrache:  To remain future-proof, the Biotech Act must be designed to evolve alongside scientific progress, market dynamics and patient needs. Clear objectives, risk-based requirements, regular review mechanisms and timely updates to guidance will enhance regulatory agility without creating unnecessary rigidity or administrative burden.  Continuous stakeholder dialogue combined with horizon scanning will be essential to sustaining innovation, resilience and timely patient access over the long term. Preserving regulatory openness and international cooperation will be critical in avoiding fragmentation and maintaining Europe’s credibility as a global biotech hub.  Q: Looking ahead, what two or three priorities should policymakers focus on to ensure the EU Biotech Act delivers meaningful impact in practice?  Marrache: Looking ahead, policymakers should focus on three priorities for the Biotech Act:    First, implementation must deliver real regulatory efficiency, predictability and coordination in practice. Second, Europe must sustain an open and investment-friendly framework that reflects the global nature of biotechnology.  And third, policymakers should ensure a clear and coherent legal framework across the lifecycle of innovative medicines, providing certainty for the use of  artificial intelligence   —  as a key driver of innovation in health biotechnology.  In practical terms, the EU Biotech Act will be judged not by the number of new instruments it creates, but by whether it reduces complexity, increases predictability and shortens the path from scientific discovery to patient benefit. An open, innovation-friendly framework that is competitive at the global level will help sustain investment, strengthen resilient supply chains and deliver better outcomes for patients across Europe and beyond. -------------------------------------------------------------------------------- References 1. Amgen Europe, The EU Biotech Act Unlocking Europe’s Potential, May 2025. Retrieved from https://www.amgen.eu/media/press-releases/2025/05/The_EU_Biotech_Act_Unlocking_Europes_Potential 2. European Commission, Proposal for a Regulation to establish measures to strengthen the Union’s biotechnology and biomanufacturing sectors, December 2025. Retrieved from https://health.ec.europa.eu/publications/proposal-regulation-establish-measures-strengthen-unions-biotechnology-and-biomanufacturing-sectors_en 3. EFPIA, The pharmaceutical sector: A catalyst to foster Europe’s competitiveness, February 2026. Retrieved from https://www.efpia.eu/media/zkhfr3kp/10-actions-for-competitiveness-growth-and-security.pdf 4. The Parliament, Investing in healthy societies by boosting biotech competitiveness, November 2024. Retrieved from https://www.theparliamentmagazine.eu/partner/article/investing-in-healthy-societies-by-boosting-biotech-competitiveness#_ftn4 5. Amgen Europe, The EU Biotech Act Unlocking Europe’s Potential, May 2025. Retrieved from https://www.amgen.eu/docs/BiotechPP_final_digital_version_May_2025.pdf   6. European Commission, combine programme, June 2023. Retrieved from https://health.ec.europa.eu/medical-devices-topics-interest/combine-programme_en  7. European Commission. Medical Devices – In Vitro Diagnostics, March 2026. Retrieved from https://health.ec.europa.eu/medical-devices-vitro-diagnostics_en 8. European Commission, Clinical trials – Regulation EU No 536/2014, January 2022. Retrieved from https://health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-regulation-eu-no-5362014_en 9. European Commission, Simpler and more effective rules for medical devices – Commission proposal for a targeted revision of the medical devices regulations, December 2025. Retrieved from https://health.ec.europa.eu/medical-devices-sector/new-regulations_en#mdr 10. Amgen Europe, The EU Biotech Act Unlocking Europe’s Potential, May 2025. Retrieved from https://www.amgen.eu/docs/BiotechPP_final_digital_version_May_2025.pdf   11. AmCham, EU position on the Commission Proposal for an EU Biotech Act 12. European Commission, AI Act | Shaping Europe’s digital future, June 2024. Retrieved from https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai 13. European Commission, European Health Data Space, March 2025. Retrieved from https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en 14. The Parliament, Why Europe needs a Biotech Act, October 2025. Retrieved from https://www.theparliamentmagazine.eu/partner/article/why-europe-needs-a-biotech-act -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Amgen Inc * The ultimate controlling entity is Amgen Inc * The political advertisement is linked to advocacy on the EU Biotech Act. More information here.

Dr. Daniel Steiners This is not an obituary for Germany’s economic standing. It is an invitation to shift perspective: away from the language of crisis and toward a clearer view of our opportunities — and toward the confidence that we have more capacity to shape our future than the mood indicators might suggest. For years, Germany seemed to be traveling along a self-evident path of success: growth, prosperity, the title of export champion. But that framework is beginning to fray. Other countries are catching up. Parts of our industrial base appear vulnerable to the pressures of transformation. And global dependencies are turning into strategic vulnerabilities. In short, the German model of success is under strain. Yet a glance at Europe’s economic history suggests that moments like these can also contain enormous potential — if strategic thinking and decisive action come together. One example, which I find particularly striking, takes us back to 1900. At the time, André and Édouard Michelin were producing tires in a relatively small market, when the automobile itself was still a niche product. They could have focused simply on improving their product. Instead, they thought bigger; not in silos, but in systems. With the Michelin Guide, they created incentives and orientation for greater mobility: workshop directories, road maps, and recommendations for hotels and restaurants made travel more predictable and attractive. What began as a service booklet for motorists gradually evolved into an entire ecosystem — and eventually into a globally recognized benchmark for quality. > In times of change, those who recognize connections and are willing to shape > them strategically can transform uncertainty into lasting strength. What makes this example remarkable is that the real innovation did not lie in the tire itself or merely even a clever marketing idea to boost sales. It lay in something more fundamental: connected thinking and ecosystem thinking. The decision to see mobility as a broad space for value creation. It was the courage to break out of silos, to recognize strategic connections, to deepen value chains — and to help define the standards of an emerging market. That is precisely the lesson that remains relevant today, including for policymakers. In times of change, those who recognize connections and are willing to shape them strategically can transform uncertainty into lasting strength. Germany’s industrial health economy is still too often viewed in public debate in narrowly sectoral terms — primarily through the lens of health care provision and costs. Strategically, however, it has long been an industrial ecosystem that spans research, development, manufacturing, digital innovation, exports and highly skilled employment. Just as Michelin helped shape the ecosystem of mobility, Germany can think of health as a comprehensive domain of value creation. The industrial health economy: cost driver or engine of growth? Yes, medicines cost money. In 2024, Germany’s statutory health insurance system spent around €55 billion on pharmaceuticals. But much of that increase reflects medical progress and the need for appropriate care in an aging society with changing disease patterns. Innovative therapies benefit both patients and the health system. They can improve quality and length of life while shifting treatment from hospitals into outpatient care or even into patients’ homes. They raise efficiency in the system, reduce downstream costs and support workforce participation. > In short, the industrial health economy is not merely part of our health care > system. It is a key industry, underpinning economic strength, prosperity and > the financing of our social security systems. Despite public perception, pharmaceutical spending has remained remarkably stable for years, accounting for roughly 12 percent of total expenditures in the statutory health insurance system. That figure also includes generics — medicines that enter the ‘world heritage of pharmacy’ after patent protection expires and remain available at low cost. Truly innovative, patent-protected medicines account for only about seven percent of total spending. Against these costs stands an economic sector in which Germany continues to hold a leading international position. With around 1.1 million employees and value creation exceeding €190 billion, the industrial health economy is among the largest sectors of the German economy. Its high-tech products, bearing the Made in Germany label, are in demand worldwide and contribute significantly to Germany’s export surplus. In short, the industrial health economy is not merely part of our health care system. It is a key industry, underpinning economic strength, prosperity and the financing of our social security systems. Its overall balance is positive. The central question, therefore, is this: how can we unlock its untapped potential? And what would it mean for Germany if we fail to recognize these opportunities while economic and innovative capacity increasingly shifts elsewhere? Global dynamics leave little room for hesitation Governments around the world have long recognized the strategic importance of the industrial health economy — for health care, for economic growth and for national security. China is demonstrating remarkable speed in scaling and implementing biotechnology. The United States, meanwhile, illustrates how determined industrial policy can look in practice. Regulatory authorities are being modernized, approval procedures accelerated and bureaucratic barriers systematically reduced. At the same time, domestic production is being strategically strengthened. Speed and market size act as magnets for capital — especially in a sector where research is extraordinarily capital-intensive and requires long-term planning security. When innovation-friendly conditions and economic recognition of innovation meet a large, well-funded market, global shifts follow. Today roughly 50 percent of the global pharmaceutical market is located in the United States, about 23 percent in Europe — and only 4 to 5 percent in Germany. This distribution is no coincidence; it reflects differences in economic and regulatory environments. At the same time, political pressure is growing on countries that benefit from the American innovation engine without offering an equally attractive home market or recognizing the value of innovation in comparable ways. Discussions around a Most Favored Nation approach or other trade policy instruments are moving in precisely that direction — and they affect Europe and Germany directly. For Germany, the implications are clear. Those who want to attract investment must strengthen their competitiveness. Those who want to ensure reliable health care must appropriately reward new therapies. Otherwise, these global dynamics will inevitably affect both the economy and health care at home. Already today, roughly one in four medicines introduced in the United States between 2014 and 2023 is not available in Europe. The gap is even larger for gene and cell therapies. The primacy of industrial policy: from consensus to action — now Germany does not lack potential or substance. We still have a strong industrial base, a tradition of invention, outstanding universities and research institutions, and a private sector willing to invest. Political initiatives such as the coalition agreement, the High-Tech Agenda and plans for a future strategy in pharmaceuticals and medical technology provide important impulses, which I strongly welcome. > A fair market environment without artificial price caps or rigid guardrails is > the strongest magnet for private capital, long-term investment and a resilient > health system. But programs must now translate into a coherent action plan for growth. We need innovation-friendly and stable framework conditions that consider health care, economic strength and national security together — as a strategic ecosystem, not as separate silos. The value of medical innovation must also be recognized in Germany. A fair market environment without artificial price caps or rigid guardrails is the strongest magnet for private capital, long-term investment and a resilient health system. Faster approval procedures, consistent digitalization and a determined reduction of bureaucracy are essential if speed is once again to become a competitive advantage and a driver of innovation. Germany can reinvent itself, of that I am convinced. With courage, strategic determination and an ambitious push for innovation. The choice now lies with us: to set the right course and unlock the potential that is already there.

BRUSSELS — Ursula von der Leyen has summoned her team of European commissioners to a meeting to try to defuse mounting tensions and improve the way they work. The meeting is set for Feb. 4 in Leuven and is open to all members of the College, though attendance is not mandatory, according to a Commission official involved in organizing the event. The idea for such a meeting was conceived after tense exchanges between commissioners and frustration at the repeated late arrival of files on the desks of top officials, Commission officials said. POLITICO spoke to eight officials from different commissioners’ cabinets, all of whom were granted anonymity to speak candidly about the internal dynamics. While the meeting will focus on competitiveness and will feature a special guest — IMF Managing Director and former Commission Vice President Kristalina Georgieva — also on the agenda are discussions on “geopolitics in the current context and the working methods of the European Commission,” Commission deputy chief spokesperson Arianna Podestà told POLITICO. The latter element was prompted by what staffers inside the Berlaymont, the Commission’s HQ, describe as an unusually tense atmosphere. The spark for the idea of the meeting, according to four of the Commission officials, was a tense exchange in early December in which Dan Jørgensen, the energy commissioner, confronted Executive Vice President Teresa Ribera during a meeting of the College of Commissioners — as first reported in Brussels Playbook. Jørgensen will be attending the Feb. 4 meeting, his team said. Ribera’s team did not respond. | Thierry Monasse/Getty Images Both commissioners declined to comment on the incident but one official said Jørgensen had raised his voice when confronting Ribera, while another said the Danish commissioner “made a point toward Ribera that was unusually forceful by College standards” as they discussed a key environmental file. Jørgensen will be attending the Feb. 4 meeting, his team said. Ribera’s team did not respond. Meetings of the full College in the new year are not unusual, and in fact have been a regular practice since 2010, Podestà told POLITICO. However, this one features a session explicitly dedicated to finding better working methods and preventing differences of opinion between commissioners from getting out of hand. Descriptions of the meeting varied, with one official calling it “talks” rather than a formal team-building exercise, and another describing it as “a working group on working methods.” Several Cabinets are growing frustrated with files arriving on their desk just hours before College meetings, or late at night, on the weekend, or on the eve of the presentation of legal proposals. “This prevents us from working professionally,” one official said. “Of course emergencies happen but this can’t be the norm.” The frustration peaked during the presentation of the EU’s long-term budget plan last July, when official figures were reportedly shared with commissioners only hours before the presentation. According to officials close to von der Leyen’s Cabinet, the late arrival of the budget figures was justified as a tactic to prevent leaks. But the approach has only deepened irritation inside the College. According to one official, the “altercation” between Jørgensen and Ribera also concerned fast-tracking files. To get a file presented to the College, an executive vice president must “push the button” (Berlaymont jargon for putting something on the agenda). Faced with a tight deadline to examine the details of a file — the environmental omnibus, designed to simplify green rules — Ribera decided to wait before pushing the button, as she is entitled to do, according to her team. This led to tensions with Jørgensen, a fellow member of the socialist family. One Commission official noted that both center-left commissioners lead teams “with strong views,” making friction likely. “There’s a lot more infighting in [the] College than one might think,” a Commission official said. Some of these frictions reflect genuine differences of opinion but are magnified by a highly centralized system, in which many decisions must get approval on the 13th floor of the Berlaymont — home to von der Leyen’s Cabinet. “The way it works now creates situations that are avoidable and some problems where there aren’t any,” another official said. Jørgensen and Ribera are not the only pair under strain. Tensions have surfaced between Executive Vice President Stéphane Séjourné and Health Commissioner Olivér Várhelyi, for example, particularly over the Biotech Act. Várhelyi has long objected to the package’s non-health elements, and insiders say his resistance has only hardened as Séjourné pushes a broader industrial strategy. Two officials also said Várhelyi’s behavior is sometimes interpreted as provocative — keeping his phone ringtone on or sprawling in his chair. According to the same officials, Várhelyi has even insisted that only von der Leyen, not fellow commissioners, may substitute for him at events. Neither Séjourné nor Várhelyi responded to requests for comment. Séjourné will not be present at the seminar, as he is taking part in ministerial discussions in Washington on critical raw materials, but will submit written contributions, according to his team. Várhelyi did not confirm if he would be attending the Feb. 4 meeting. Commission officials say that friction between EVPs and other commissioners is almost built into the system. EVPs are meant to coordinate and oversee the work of others, whereas under EU law all commissioners are supposed to be equal. That ambiguity, one official said, is manageable on good days, but doesn’t help when tempers flare. Von der Leyen did not respond to requests for comment. The meeting comes ahead of an EU leaders’ retreat on competitiveness scheduled for Feb. 12.

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.

C-ANPROM/EUC/NON/0052 -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Takeda * The advertisement is linked to policy advocacy around and industrial policy agenda, including the Pharma Package, Biotech Act, Life Sciences Strategy, and related digital and innovation frameworks. More information here

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.

Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Bayer AG * The advertisement is linked to policy advocacy around biotechnology, life sciences, and innovation policy in the European Union, including the EU’s proposed Biotech Act and Life Sciences Strategy More information here.

LONDON — The American drugmaker Eli Lilly wants to see more changes to Britain’s medicine market before it pivots on its abandoned £279 million investment in a biotech incubator project. The U.K. government 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 Donald Trump’s administration. The U.S. president has demanded lower drug prices for Americans, and suggested other developed countries should pay more. The British plans under consideration could increase the threshold at which the NHS pays firms for medicines by up to 25 percent. But for the U.S. pharmaceutical company — which shelved its planned facility meant to support early-stage life sciences businesses with lab space, mentorship and potential financial backing — the proposal alone is not enough. “I don’t think we have heard enough to say that we are willing to get the Lilly Gateway Lab started,” Patrik Jonsson, president of Lilly’s international business, which covers all markets outside the U.S., told POLITICO. “I think once we see the right signs from the U.K. government, we’re more than happy to restart those discussions, and we could move quite quickly,” Jonsson said. However, “we need to see some significant and sustainable change here.” The comments will be a blow to British negotiators, who are in advanced talks to agree their drug-pricing deal with the U.S. administration as part of wider trade negotiations. Officials are hoping to wrap up the pharma talks ahead of the U.K.’s budget in late November. Ministers last week granted a two-week extension to the deadline by which pharma firms must tell the government if they intend to leave the NHS’s voluntary drug pricing scheme. If Washington and London strike a deal — effectively committing the NHS to higher drug spending — Chancellor Rachel Reeves will face pressure to spell out how much the increase will cost taxpayers. ‘WE NEED THE RIGHT CONDITIONS’ Drugmakers have long called for changes to the U.K.’s tightly-controlled drug prices. Britain limits the annual cost for a year of good-quality life (QALY) for a patient at £30,000 for most drugs. Industry also pays an annual rebate to the NHS at 23 percent of their U.K. sales. These measures have contained the medicine bill for the U.K.’s publicly-funded health care system. While Jonsson acknowledged the U.K. is “well positioned to be a source of innovation” thanks to a “small but really impressive group of scientists,” he said the country needs to demonstrate sustained changes. The British plans under consideration could increase the threshold at which the NHS pays firms for medicines by up to 25 percent. | Anna Barclay/Getty Images “At the end of the day if you want us to research, develop and produce medicines in your country you need to put the right conditions in place so that your citizens can get access to those patients at least who need it most,” Jonsson said. An editorial in the Lancet medical journal last week said “the argument that paying more for medicines leads to more innovation is unfounded.” “If the U.K. Government wants to attract pharma investment, it should follow the evidence. Rather than handing over more money for medicines, it should invest in creating fertile conditions for attracting world-leading scientists, boosting public infrastructure for research and development, and facilitating clinical trials,” the article states. “Although the tangible outcomes of applied research might appeal to politicians, investing massively in a second-to-none basic science sector will allow scientific innovation to flourish.” Jonsson was speaking to POLITICO as the company announced a €2.6 billion new manufacturing facility in the Netherlands to produce oral medicines, including its first GLP-1 weight-loss pill. A Department of Health and Social Care spokesperson said: “We will always prioritise the needs of NHS patients. Investment in patient access to innovative medicines is critical to our NHS. “We are now in advanced discussions with the US Administration to secure the best outcome for the UK, reflecting our strong relationship and the opportunities from close partnership with our pharmaceutical industry,” the spokesperson added.

The European Commission is set to unveil the Biotech Act I, an EU cardiovascular health plan and a simplification of the bloc’s medical devices and in vitro diagnostics rules on Dec. 16, according to the latest Commission agenda published Monday. The first part of the Biotech Act will focus on the pharmaceutical industry and is being produced without a dedicated impact assessment. The second part — covering other biotech sectors — is expected in the third quarter of 2026. The upcoming cardiovascular health plan — inspired by the bloc’s Beating Cancer Plan — will cover prevention, early detection and screening, treatment and management, and rehabilitation. Meanwhile, simplification of the bloc’s medical devices and in vitro diagnostics rules comes after the regulations drove up assessment costs, caused certification delays, and led to product withdrawals from the market. Europe’s Health Commissioner Olivér Várhelyi has previously said the sector needs a “major overhaul.” Additionally, the Commission’s agenda includes a “drugs package” comprising new rules on drug precursors and an EU Drugs Strategy and European action plan against drug trafficking — both scheduled for Dec. 3.

BRUSSELS ― The European Commission has partly rejected a Hungarian plan to unblock €545 million in frozen EU funds as tensions escalate again between Brussels and Budapest. Of that amount, Hungary will only receive €163.5 million in advance payments ― and even that can be clawed back by the Commission if they are deemed to be misspent. National capitals are increasingly frustrated with Hungarian right-wing Prime Minister Viktor Orbán over his threats to torpedo tougher sanctions on Russian energy and block Ukraine’s EU membership bid and a €140 billion EU loan to the war-torn country. These issues are taking center stage at an informal summit in Copenhagen on Wednesday, where leaders are discussing moving from unanimity to qualified majority voting precisely to overcome Orbán’s veto. Against this backdrop, the Commission is holding firm against releasing a significant part of the €18 billion in EU funds it has withheld from Hungary over breaches of academic freedoms and minority rights, among other deficiencies. As a workaround, the Hungarian government proposed moving €545 million from university schemes to “strategic” industrial projects, but the plan was not fully embraced by Brussels. “We are not disbursing any funding before the horizontal enabling conditions are fulfilled and for now they are not fulfilled,” said Commission spokesperson Maciej Berestecki, referring to the broad conditions that member countries must meet in order to receive EU funds. STRATEGIC PROJECTS Nevertheless, the EU executive decided last Thursday to release €163.5 million out of the €545 million as advance payments. In this instance the Commission was bound by its own rules, which compel it to put forward 30 percent of total funding for strategic projects including critical infrastructure and biotechnology. Releasing the entire amount would likely have triggered a backlash from the European Parliament and EU capitals ― especially those in Northern Europe, which are the most annoyed at Orbán’s antics. Given Hungary’s repeated threats to use its national veto to block some of the EU’s biggest initiatives, keeping most of the funds frozen gives Brussels more leverage to secure concessions on strategic files, said a Commission official with knowledge of the process who was granted anonymity to speak freely. The Commission’s official reason for keeping most of the €545 million blocked is that it fears Hungary could still siphon that cash toward universities. The Commission has repeatedly urged Budapest to restore academic freedoms in order to unblock the money stream. “The Commission considered that the horizontal enabling conditions can be fulfilled only if the universities run by so-called public interest trusts are clearly excluded from these new priorities, or the issues raised by the Commission in the past concerning the public interest trusts are resolved,” Berestecki wrote in a statement. Hungary’s request predates a midterm revamp of regional funding that makes it easier to reshuffle funding across different policy areas. Critics claim that Budapest will use this loophole to try to unblock other funding in the future.