With one of the fastest-aging populations in the world, Europe will never be this young again. By 2050, one in three Europeans will be 65 or older, an age when Alzheimer’s disease risk starts doubling every five years. While breakthrough treatments are changing the trajectory of Alzheimer’s disease in other parts of the world, Europe is lagging in access and investment, cutting many people off from care options that could improve their lives. A global shift toward early intervention is showing what is possible, with patients starting to be diagnosed in time for treatment to have an impact.[1], [2] Detecting the disease early is like diagnosing cancer at stage one rather than stage four. It can make a profound difference for patients and families in the moments that matter most. Timely treatment can provide more independence, connection and time to make informed choices. > Detecting the disease early is like diagnosing cancer at stage one rather than > stage four. It can make a profound difference for patients and families in the > moments that matter most. Worldwide, 23 regulators have approved disease modifying therapies for Alzheimer’s disease, signaling growing confidence in these medicines. Four of the world’s largest economies also provide reimbursement so that cost is not a barrier. Yet in much of Europe, people living with the disease remain unable to access these innovations. Some countries have authorized treatments but failed to provide a reimbursement pathway, creating a two-tiered healthcare system where wealthier patients can afford treatment while others are left behind. Recent developments in the UK offer a cautiously encouraging signal. The appeal process through the National Institute for Health and Care Excellence has acknowledged that the full value of innovation, including the impact on unpaid carers and the broader burden on informal carers, must be part of the conversation. This is a welcome recognition that systems need to evolve. Health technology assessment frameworks were largely designed to measure short-term, direct healthcare costs for acute interventions. They recognize clinical benefit in narrow terms, and overlook the wider impact that early intervention delivers across health and social care systems:[3] fewer years in residential and nursing home care and a reduced burden on unpaid carers. Such considerations matter enormously to patients and families, yet their voice often remains unheard in the decision-making of many European countries. The cost of this miscalculation compounds. Families are denied treatments that exist today, and future generations inherit health systems ill-equipped for the challenge ahead. Delay is already costing families and health systems When systems delay action, the burden doesn’t disappear. It shifts to families and it costs people good days with their loved ones. Dementia carries the highest global burden of disability, stealing more total years of quality life and independence than any other disease. Its economic toll is staggering, costing Europe 40 percent more than all cancers combined. The vast majority of those costs fall on families and social care. This also increases sharply as the disease progresses, going up by approximately €25,000 more per year as it moves from mild to severe.[4] Slowing disease progression eases the burden on millions of family members who      put aside their own careers and well-being to look after loved ones as unpaid carers.[5]      Yet the 90 percent of dementia costs that fall outside direct healthcare are routinely excluded from value assessments. 4 Including them would fundamentally change the equation. New medicines to treat Alzheimer’s disease have achieved efficacy and safety profiles on par with leading cancer and multiple sclerosis treatments, yet they face more skepticism. 4 Part of the problem is that diseases long considered untreatable suffer from underinvestment in care pathways. When treatments finally arrive, it is families who bear the consequences of health systems that are slow to adapt. This is where leaders can act. When assessing whether these treatments are worth paying for, policymakers must consider the full economic picture, one that captures the long-term value that early intervention delivers, not just short-term direct costs. Science is moving. Europe can lead or fall behind. At a time when European leaders are debating competitiveness, biotech leadership and fiscal sustainability, Alzheimer’s disease is not just a health issue. It is a test of whether Europe can adapt its systems to demographic reality, or allow the gap between scientific progress and patient access to widen further. European policymakers should give people this choice to know and act early. That begins with two priorities: enabling access to innovative diagnostics and treatments within a stronger system of care, and modernizing value assessment so it captures the full benefit of innovation, accounting for long-term savings across health and social care, not just short-term direct costs. > Alzheimer’s disease is not just a health issue. It is a test of whether Europe > can adapt its systems to demographic reality, or allow the gap between > scientific progress and patient access to widen further. By expanding diagnosis and access to innovation, Europe can help more people age with dignity, while reinforcing its position as a destination for research, clinical trials      and long-term investment. Europeans deserve the choice that science now makes possible. If leaders recognize the need for change, the time to act on it is now. -------------------------------------------------------------------------------- [1] Eckhardt, J. “Breakthroughs Changing The Diagnosis And Treatment Of Alzheimer’s” Forbes (2025) Breakthroughs Changing The Diagnosis And Treatment Of Alzheimer’s (Accessed March 15, 2026) [2] Beasley, B. “I Caught My Alzheimer’s at 57, Early Enough to Intervene.” The Wall Street Journal (2026). https://www.wsj.com/opinion/i-caught-my-alzheimers-at-57-early-enough-to-intervene-15072207 (Accessed March 15, 2026) [3] EFPIA. “Taking Action Together to Ensure a Brighter Today and Tomorrow for People with Alzheimer’s Disease.” Position Paper. https://www.efpia.eu/media/412735/taking-action-together-to-ensure-a-better-today-and-tomorrow-for-people-with-alzheimer-s-disease.pdf [4] Frisoni GB, Aho E, Brayne C, et al. “Alzheimer’s disease outlook: controversies and future directions.” The Lancet, Vol. 406, No. 10510, pp. 1424–1442 (September 2025). [5] Abi-Saleh N, So D, Molenkamp V. “Addressing the Impact of Alzheimer’s Disease on Care Capacity in the Netherlands: Implications for Health Technology Assessment.” Poster presentation, ISPOR Europe 2025. https://www.ispor.org/heor-resources/presentations-database/presentation-cti/ispor-europe-2025/poster-session-1-2/addressing-the-impact-of-alzheimer-s-disease-on-care-capacity-in-the-netherlands-implications-for-health-technology-assessment -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Eli Lilly & Company. * The entity ultimately controlling the sponsor is Eli Lilly & Company. * This article calls on European policymakers to reform health technology assessment and reimbursement systems to improve access to Alzheimer’s diagnostics and treatments, explicitly aiming to influence public health policy in Europe. More information here.

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.

The humanitarian crisis in Gaza is “still catastrophic” and has seen only a “marginal” improvement since the ceasefire, with worse to come due to the Middle East war, senior World Health Organization officials told reporters Thursday. There are $6 million worth of medicines that can’t reach Gaza due to supply disruptions in the Middle East, Hanan Balkhy, WHO director for the Eastern Mediterranean region, said. The chaos “will take away, for sure, from the support needed for the people in Gaza,” she said. Israel closed border crossings in and out of Gaza after striking Iran last weekend, claiming the enclave had adequate humanitarian supplies and there would be “no impact on the humanitarian situation.” Israel said Tuesday it would reopen the crossing to allow for the “gradual entry of humanitarian aid,” reported Le Monde with AFP. Balkhy, however, said the volume of aid entering Gaza “was and is not enough,” while WHO Director-General Tedros Adhanom Ghebreyesus said the improvement since the ceasefire was “actually marginal.” “We need 600 trucks to cross into Gaza every single day but currently it’s not more than between 100 and 150,” Tedros said, adding the border closures had interrupted “good progress” on the number of medical evacuations. “I would like to use this opportunity actually to ask Israel to allow us to take patients [from Gaza] to east Jerusalem and [the] West Bank,” Tedros said. Some of the trucks entering Gaza were “commercial” and didn’t really help people who couldn’t afford the supplies, he said. POLITICO contacted Israel’s Coordinator of Government Activities in the Territories for comment, but did not receive an immediate response.

Today, cancer remains one of Europe’s leading causes of death and disability, accounting for 23 percent of all deaths in 2022 and 17 percent of disability-adjusted life years in 2021. Four Europeans are diagnosed with cancer every minute, a number that is expected to rise over the next several decades due to population aging. As the EU Beating Cancer Plan reaches the end of its initial phase, Europe now stands at a critical moment. The question is not whether progress has been made, but whether Europe will build on that momentum or allow it to stall, with consequences not only for health outcomes, but also for economic growth and scientific leadership. Gilles Marrache At this juncture, cancer care must be understood not as a cost to be contained, but also as a strategic investment that delivers measurable returns in survival, productivity and Europe’s global competitiveness. > Continued investment in oncology is therefore not only a moral imperative but > also a proven economic and social multiplier. Cancer innovation delivers proven returns Investment in cancer innovation has already delivered extraordinary value for European patients and societies. Since 1989, advances in oncology have helped prevent an estimated 5.4 million deaths. More recently, since 2012, innovative cancer medicines have generated approximately 1.1 million quality-adjusted life years, all while accounting for just 6.6 percent of total health budgets. These gains are not abstract. They represent longer lives, improved quality of life, and the ability for people to remain active contributors to their families, workplaces and communities. Continued investment in oncology is therefore not only a moral imperative but also a proven economic and social multiplier. Delayed access is holding Europe back Despite these returns, Europe continues to struggle with timely access to innovative cancer medicines and diagnostics. According to EFPIA’s 2025 W.A.I.T. data, only 46 percent of centrally approved innovative medicines are available to patients on average across Europe, with a mean delay of 578 days between EU approval and patient access. In oncology, these waits have grown since 2023, which undermines patient outcomes and weakens Europe’s competitiveness in health innovation. Europe’s innovation edge is at risk Without decisive action, Europe risks falling further behind other regions. High-income European countries currently invest roughly half as much per capita in innovative medicines as the United States. This gap is driven largely by differences in how new therapies are valued, assessed and reimbursed. The impact of this underinvestment is already visible. Over the past two decades, Europe has lost around a quarter of its global share of biopharmaceutical research and development. Along with that loss comes fewer high-quality jobs, reduced private investment and weakened strategic autonomy in a sector that is increasingly central to economic and health security. > evidence suggests that every euro invested in health can generate up to four > euros in economic value, unlocking an estimated €10 trillion in GDP and saving > up to 60 million lives. Smart health investment drives growth and resilience By increasing targeted investment in innovative medicines, including in oncology, Europe can improve health outcomes for citizens, support workforce participation  and stimulate sustainable economic growth. Globally, evidence suggests that every euro invested in health can generate up to four euros in economic value, unlocking an estimated €10 trillion in GDP and saving up to 60 million lives. What European policymakers should do next To support oncology patients and safeguard innovation, regional and national governments must act across policy, funding and access: — Value what matters: modernize health technology assessment frameworks to better capture the full societal and economic benefits of innovation, while reducing duplicative and inefficient evidence requirements. This is particularly important as oncology products begin going through the new EU Joint Clinical Assessment. — Accelerate access: introduce time-bound, predictable pricing and reimbursement pathways; address regional and formulary-level delays; and invest in diagnostic and biomarker testing capacity to ensure patients receive the right treatment at the right time. — Back prevention and screening: fully finance the EU Beating Cancer Plan’s screening ambitions and scale proven pilot programmes that detect cancer earlier and improve outcomes. — Invest in innovation: increase public spending on innovative medicines in line with their true societal impact, while eliminating clawbacks and other cost-containment measures that disproportionately undermine the value of these therapies. A defining choice for Europe Europe stands at a crossroads. It can choose to invest now in cancer innovation, which would help to close survival gaps, strengthen competitiveness and deliver long-term value for citizens. Or it can allow delays, underinvestment and fragmented policies to widen those gaps further. Aligning policy, funding and access around innovation would not only improve cancer outcomes but make health one of Europe’s most powerful and sustainable investments for the future.     -------------------------------------------------------------------------------- POLITICAL ADVERTISEMENT * The sponsor is European Federation of Pharmaceutical Industries and Associations (EFPIA) * The political advertisement is linked to advocacy on securing a technology-neutral EU road-transport decarbonisation framework through recognition of renewable fuels, strengthened grid and infrastructure enablers, and avoiding mandates that limit operators’ choice and competitiveness. * The ultimate controlling entity is European Federation of Pharmaceutical Industries and Associations (EFPIA) More information here.

Europe’s ambition to become climate neutral by 2050 cannot succeed in healthcare unless we fix a basic problem: we do not measure sustainability in the same way across the single market. Currently, measuring Product Carbon Footprints (PCF) and Life Cycle Assessments (LCA) throughout the European Union consists of a patchwork of national methodologies and/or competing frameworks. This fragmentation is not just a technical inconvenience, it actively undermines fair procurement, increases costs, and risks unequal patient access across Europe.[1] Without a single, harmonized methodology or framework, this EU sustainability and competitiveness goal will remain challenging to achieve. Though the lack of harmonizsation may seem technical, its consequences are tangible. PCF and LCA outputs can differ widely depending on the standards and methodologies defined and endorsed by policymakers, the way they are applied by industry, or how existing international standards are interpreted and implemented across member states.[2] The result is that national authorities are effectively speaking different languages. A treatment considered more environmentally responsible in one country may be evaluated entirely differently just across the border. And without harmonized sustainability assessments for medicines, there is a risk that sustainability is given disproportionate weight compared with safety and quality, undermining high-quality medicine development. In short, fragmentation slows progress, weakens trust and, importantly, – prevents comparability. [1]  > In short, fragmentation slows progress, weakens trust and, importantly, – > prevents comparability. In practice, the absence of a harmonized standard allows 27 different interpretations of ‘sustainability’ to coexist, which is incompatible with a functioning single market. Fortunately, PAS 2090:2025 offers what the EU has been missing: a single, science-based methodology that allows regulators, procurers, and industry to finally speak the same language. Developed with stakeholders across the healthcare and life sciences sector, PAS 2090:2025 specifies the appropriate methodology for medicines under ISO standards, aligning the playing field for everyone involved. Published by the British Standards Institution in November 2025, it reflects broad technical consensus and strong credibility. PAS 2090:2025 provides the first practical methodology for measuring the environmental performance of pharmaceuticals, establishing a common framework to support comparable environmental reporting, reduce regulatory duplication and provide policymakers with a credible basis to demonstrate progress toward climate neutrality. It also gives industry the predictability needed to invest in sustainable innovation, while ensuring that patients receive consistent assessments of a treatment’s environmental profile, regardless of where it is evaluated. Importantly, this approach reflects principles already embedded in EU policymaking. The European Health Data Space, for example, demonstrates how interoperability and standardized frameworks are essential in making cross-border data meaningful and actionable.[3] Meanwhile, the European Commission has been equally clear: harmonized technical standards and coherent sustainability rules are critical to the effective functioning of the Single Market and ensuring the free movement of goods.[4] This is a shared concern across stakeholder groups. Both the Federation of European Academies of Medicine and European Academies’ Science Advisory Council, representing Europe’s leading academies of medicine and science, have similarly highlighted the fact that common standards are essential for transparent procurement and fair competition across therapeutic categories.[5]And the innovative pharmaceutical industry, via the European Federation of Pharmaceutical Industries and Associations, has outlined both the challenges caused by the absence of harmonized standards and called for policymakers, regulators and healthcare stakeholders to endorse PAS 2090:2025 as the one, internationally accepted standard for measuring PCA and LCA in the pharmaceutical industry.[6]Europe’s leading academies of medicine and science, the European Commission, and the innovative pharmaceutical sector all point to the same conclusion: without harmonized standards, sustainability policy cannot work. > At Chiesi, we support PAS 2090:2025 not because it is convenient, but because > it makes our environmental performance directly comparable and therefore > accountable.[2]  That is why our teams have laid out ambitious, yet reachable, targets regarding the reduction of Scope 1, 2 and 3 greenhouse gas emissions. We also know that in order to reach these targets, we need to measure our actions and emissions. Measuring what matters is the foundation to making a meaningful difference.[3]  > Measuring what matters is the foundation to making a meaningful > difference.[3]  Our support for PAS 2090:2025 reflects a commitment to transparency, science-based decision-making and long-term sustainability; we use it ourselves because we believe it is the way forward — making it simple to compare products fairly, design transparent tenders, and procure with clarity. Further, industry members will be able to innovate with confidence, knowing that the life-changing efforts will be assessed with science and clear understandings. That said, no single actor can deliver alignment alone. Real progress depends on collaboration between regulators, policymakers, scientific bodies, and industry around a shared approach to measuring and comparing environmental impact. Chiesi stands ready to work with policymakers and partners across the healthcare ecosystem in favor of the adoption of PAS 2090:2025, understanding that achieving true regulatory harmonization is essential for ensuring patient access, maintaining high safety and quality standards, and fostering a globally competitive pharmaceutical industry in Europe. At the end of the day, the EU does not need another pilot program, framework, or national workaround. It needs a decision. It needs action. Europe must agree on how sustainability in healthcare is measured consistently and credibly across the single market. Measuring what matters, in the same way across Europe, is the only path to a climate-neutral, competitive, and fair European health system. Endorsing PAS 2090:2025 as the reference methodology would turn that principle into practice. Andrea Bonetti Andrea Bonetti is head of the EU office at Chiesi Farmaceutici, where he oversees the company’s public affairs strategy at European level across healthcare, sustainability and planetary health. Since opening Chiesi’s Brussels office in 2020, he has strengthened the company’s engagement with EU institutions, contributed to key policy discussions and supported initiatives to advance awareness on climate and environmental priorities in line with Chiesi’s values. He collaborates closely with cross-functional teams on the development and implementation of Chiesi’s sustainability strategy and represents the company within European and international trade associations. With more than 15 years of experience in health and environmental policy, he supports Chiesi’s external positioning and contributes to sector-wide work on environmental and sustainability frameworks. Disclaimer: POLITICAL ADVERTISEMENT * The sponsor is Chiesi Farmaceutici * The political advertisement is linked to advocacy on EU sustainability and Single Market policy. More information here. -------------------------------------------------------------------------------- [1] European Commission. (2023). Annual Single Market Report 2023. https://single-market-economy.ec.europa.eu/system/files/2023-01/ASMR%202023.pdf   [2] Healthcare Without Harm. (2022). Report: Procuring for greener pharma. https://europe.noharm.org/media/4639/download?inline=1   [3] European Union. (2025). Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847. https://eur-lex.europa.eu/eli/reg/2025/327 [4] European Commission. (2026). Public procurement. https://single-market-economy.ec.europa.eu/single-market/public-procurement_en [5] European Academies’ Science Advisory Council (EASAC) & Federation of European Academies of Medicine (FEAM). (2021). Decarbonisation of the health sector: A commentary by EASAC and FEAM. https://easac.eu/fileadmin/PDF_s/reports_statements/Health_Decarb/EASAC_Decarbonisation_of_Health_Sector_Web_9_July_2021.pdf.pdf [6]European Federation of Pharmaceutical Industries and Associations (EFPIA). (2025). Advancing environmental sustainability assessment of pharmaceuticals through standardisation and harmonisation of product carbon footprint assessment. https://www.efpia.eu/news-events/the-efpia-view/efpia-news/advancing-environmental-sustainability-assessment-of-pharmaceuticals-through-standardisation-and-harmonisation-of-product-carbon-footprint-assessment/ --------------------------------------------------------------------------------  

STRASBOURG — The European Parliament has voted today to set up an EU fund to expand access to abortion for women across the bloc, in a historic vote that divided lawmakers. The plan would establish a voluntary, opt-in financial mechanism to help countries provide abortion care to women who can’t access it in their own country and who choose to travel to one with more liberal laws. European citizens presented the plan in a petition — through the campaign group “My Voice, My Choice.” Lawmakers in Strasbourg voted 358 in favor and 202 against the proposal, and 79 MEPs abstained. The topic sparked animated discussions in the European Parliament plenary on Tuesday evening. MEPs with center-right and far-right groups tabled competing texts to the resolution put forward by Renew’s Abir Al-Sahlani on behalf of the women’s rights and gender equality committee. Supporters of the scheme argued it would help reduce unsafe abortions and ensure women across the bloc have equal rights; those who oppose it, mostly from conservative groups, dismissed it as an ideological push and EU overreach into national policy. Abortion laws vary greatly across the EU, from near-total bans in Poland and Malta to liberal rules in the Netherlands and the U.K. The fund could be a game changer for the thousands of European women who travel every year to another EU country to access abortion care. The European Commission now has until March 2026 to give a response. This story is being updated.

Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Zentiva * The advertisement is linked to policy advocacy around the challenges faced by the off-patent medicines industry, in particular the Urban Wastewater Treatment Directive. More information here

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.

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