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

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

Epilepsy affects 50 million people globally and 6 million in the EU.1 Despite this, it is a chronically underfunded and underserved condition in need of strategic investment. The latest report from Headway1 — a survey dedicated to tracking and analysing epilepsy care in the EU — underscores the urgent funding gap across the EU in epilepsy care. At the launch of the latest report in Brussels, members of the European Parliament, advocacy and patient organizations, key industry leaders, and I discussed the current picture painted by the report, and the decisions we must make to support the European epilepsy community.  Overcoming barriers to epilepsy care  Epilepsy continues to be one of the most significant neurological conditions across Europe. As the fourth most common neurological disorder,2 it takes a startling toll on people’s health. People with epilepsy tend to have more physical problems (such as fractures and bruising from injuries related to seizures), as well as higher rates of psychological conditions, including anxiety and depression.3 Defined as a chronic non-communicable neurological disease, epilepsy is characterized by unprovoked seizures often associated with neurobiological, cognitive and social consequences.4   Despite the size of the patient population, the condition is often hidden and therefore heavily stigmatized, with such stigma contributing to a crisis of care. Nearly 40 percent of people living with epilepsy in Europe remain untreated, a figure that rises as high as 90 percent in underserved areas.5 Moreover, individuals with epilepsy have more than a twofold increased risk of premature death compared with the general population, and their life expectancy is reduced by approximately 10-12 years.6   > Individuals with epilepsy have more than a twofold increased risk of premature > death compared with the general population, and their life expectancy is > reduced by approximately 10-12 years. Epilepsy is not currently recognized in some countries as a brain disorder, and while new treatments have been coming to the EU, the scarce investment in brain health impacts access to care, which is already unequal — subject to geographic lottery, socioeconomic status and gender. Additionally, the stigma associated with epilepsy, alongside limited seizure control, significantly hinders social and economic inclusion, resulting in individuals with epilepsy feeling isolated, engaged in lower employment rates and without long-term financial security.   Addressing these barriers is not just a healthcare imperative, but a societal one  via Angelini Pharma Embracing brain capital  Central to the Headway report is the concept of ‘brain capital’. This framework underscores that investing in brain health, including epilepsy, is a robust economic strategy. Avoidable epilepsy-related costs are estimated to reach €49.2 billion annually within the EU27 and the U.K., which is approximately 0.28 percent of the combined GDP of the EU and the U.K.. These figures include €20.1 billion in direct costs and €29 billion in indirect costs.7   > Avoidable epilepsy-related costs are estimated to reach €49.2 billion annually > within the EU27 and the U.K., which is approximately 0.28 percent of the > combined GDP of the EU and the U.K. The Headway report outlines three return-on-investment models that address both the human and financial costs:  1. Closing the treatment gap by ensuring timely access to appropriate care could yield a return on investment of €1.9 for every €1 invested.8,9,10  2. Addressing psychiatric comorbidities, such as anxiety and depression, by integrating mental health support into standard epilepsy care can offer a return of €1.5 per €1 spent.11,12 This intervention is critical, as mental health disorders often exacerbate the challenges faced by individuals with epilepsy.  3. Preventing avoidable cases through public health strategies such as stroke prevention and improved perinatal care could present a return of €1.7 per €1 spent.13   If national health systems across the EU and the U.K. invest €1 in each of these targeted actions and allocate a larger portion of their total national healthcare budgets to brain health services such as diagnostics testing, hospitalizations and antiseizure medications, to name a few, it’s obvious that it repays itself. It also yields an additional €0.50-€0.90 in reduced healthcare spending and increased productivity of patients and caregivers. In a climate of tight healthcare budgets and growing demand, these findings provide an evidence-based roadmap to better care and stronger systems.  A unified approach to a healthier future  The Headway report is a clear wake-up call for European policymakers to prioritize epilepsy as part of the broader brain health agenda. By investing in epilepsy care and engaging the public, countries will not only improve individual health outcomes but also realize substantial economic and societal benefits in both the short and long term. Moreover, they can lead the way in global best practice by scaling up proven solutions such as deploying epilepsy-specialist nurses and modernizing clinical trial regulations, especially for complex studies, to promote person-centered care and improve outcomes.  > By investing in epilepsy care and engaging the public, countries will not only > improve individual health outcomes but also realize substantial economic and > societal benefits. Countries should establish dedicated additional funding for epilepsy and brain health research within the forthcoming EU Brain Health Partnership and Horizon Europe. Additionally, strengthening cross-border networks like EpiCARE and aligning with the World Health Organization’s IGAP framework will support EU member states and the U.K. in implementing effective national responses, improve access to highly specialized care and shared expertise, and knowledge from the inclusion of patient-reported indicators and real-world evidence. Epilepsy should be included as a distinct priority in the EU’s and member states’ mental health strategies with tailored indicators and goals for the best possible outcomes.  > The Headway report lay the foundation for a clear path to a more resilient and > inclusive society, one that ensures a future where every individual living > with epilepsy has the opportunity to thrive. The EU27 and the U.K. stand at a crossroads. The research we’ve done, the insights we’ve discussed in Brussels and the findings outlined clearly in the Headway report lay the foundation for a clear path to a more resilient and inclusive society, one that ensures a future where every individual living with epilepsy has the opportunity to thrive. The need now is for committed action. It is crucial that policymakers, medical and healthcare professionals, and those living with epilepsy come together to effect change, improve access to treatment and turn our vision into reality.  > -------------------------------------------------------------------------------- 1. Szaflaraski M (2014), “Social determinants of health in epilepsy” 2. TEHA on GBD 2021 Nervous System Disorders Collaborators (2024), “Global, regional, and national burden of disorders affecting the nervous system, 1990-2021: a systemic analysis for the Global Burden of Disease Study 2021,” 2025 3. World Health Organisation. Epilepsy. Signs and Symptoms. Available online here: https://www.who.int/news-room/fact-sheets/detail/epilepsy. (Accessed August 2025] 4. Fisher RS, et al. Epilepsia 2014;55: 475-482 5. IBE, ILAE, WHO (2011), “Epilepsy in the WHO European Region.” and European Parliament (2011), “Proceedings of the workshop ‘Treating and living with Epilepsy’” 6. Thurman DJ et al. (2014), “The burden of premature mortality of epilepsy in high-income countries: A systematic review from the Mortality Task Force of the International League Against Epilepsy”. Epilepsia. 7. TEHA on Begley C et al. (2022), “The global cost of epilepsy: A systematic review and extrapolation”, Strzelczyk et al. (2015), “Costs of epilepsy and cost‐driving factors in children, adolescents, and their caregivers in Germany”, and Willems LM et al. (2021), “Multicenter, cross-sectional study of the costs of illness andcost-driving factors in adult patients with epilepsy”, 2025 8. Kwon C et al. (2022), “The worldwide epilepsy treatment gap: A systematic review and recommendations for revised definitions – A report from the ILAE Epidemiology Commission”. Epilepsia. 9. De Zélicourt M et al. (2014), “Management of focal epilepsy in adults treated with polytherapy in France: The direct cost of drug resistance (ESPERA study)”. Seizure. 10. Willems LM et al. (2022), “Multicenter, cross-sectional study of the costs of illness and cost-driving factors in adult patients with epilepsy”. Epilepsia 11. Dewhurst E et al. (2015), “A prospective service evaluation of acceptance and commitment therapy for patients with refractory epilepsy”. Epilepsy & Behavior. 12. TEHA Group elaboration on OECD data and Fleishman JA et al. (2006), “Using the SF-12 health status measure to improve predictions of medical expenditures”. Medical Care 13. The European House of Ambrosetti and Angelini Pharma. (2025) Brain Health in Uncertain Times: A strategic investment for Europe’s future