EUCOPE - European Confederation of Pharmaceutical Entrepreneurs

🎉 2024 at EUCOPE: it's a wrap! 🙏 As the year comes to a close, we extend our heartfelt thanks to our members for their unwavering support and to all the stakeholders with whom we have collaborated throughout 2024. 📜 A pivotal year for the Healthcare and Life Sciences sector, 2024 has seen significant progress on critical legislative files, including the revision of the EU General Pharmaceutical Legislation (#GPL), the preparation of implementing acts for the EU #HTA, and the adoption of the European Health Data Space (#EHDS). 🧬 #EUCOPE continues to be the leading voice for small and mid-sized pharmaceutical companies, advocating for a supportive EU #R&D environment that fosters innovative treatments, in particular for people living with #RareDiseases.   The EUCOPE team is glad to have provided resources, insights, and guidance on 2024's crucial topics. 👉 Access them here: https://lnkd.in/ecuDJnzH 🧭 Looking ahead to 2025, we are excited to continue fostering fruitful collaboration with stakeholders across the life sciences industry. #EU #InnovativePharma #GPL #EUHTA #OMPs #ATMPs #AdvancedDiagnostics #HERA #AMR #Biotech #LifeSciences

💡 Last 2024 EUCOPE Member Spotlight 💡 To close the year on a high note, we had the privilege of speaking with Catherine Owen Adams, CEO of Acadia Pharmaceuticals Inc. 🔬 In this insightful discussion, Ms. Owen Adams shared the company’s commitment to patients and highlighted the challenges faced by the #LifeSciences industry today, especially in driving groundbreaking therapies in #RareDiseases and #neuroscience. 💬 “ Looking ahead, we’re not just delivering treatments — we partner with organizations to raise awareness, build supportive patient communities, and foster understanding of the unique challenges faced by those with rare and neurological diseases. Through education and collaboration, we aim to empower patients, caregivers, and healthcare providers with the tools they need to navigate their journeys.” 👓 Read the complete Q&A here: https://lnkd.in/dJstsdmZ #InnovativePharma #LifeSciences #Innovation

🎥 Missed the event? Watch the highlights! Held in cooperation with FTI Consulting EU, the launch of the "The Economic Lens: Understanding What Makes the EU Attractive for Life Sciences" report brought together top minds in investment, policy, and life sciences to discuss the EU’s strengths, challenges, and the future of the #PharmaceuticalSector. 💡 In case you couldn’t join, we’ve got you covered! Watch the short recap video of the insightful discussion. 💼 Topics: 🔹 How does Europe compare with the US, when attracting #investment in life sciences – what are Europe’s strengths & weaknesses? 🔹 How to improve #EUCompetitiveness for the pharmaceutical sector, also reflecting on the Draghi and Letta reports, the proposed #PharmaPackage and the future #EUAgenda? 🔹 How can the EU build a thriving pharmaceutical ecosystem, what are the challenges ahead, in particular for small and mid-sized companies? ✨ Highlights include: 💬 Keynote: MEP Stine Bosse, Vice-Chair, Subcommittee on Public Health (#SANT), European Parliament 🗣️ Insights from top industry leaders, policymakers, and investors including: 🔸 Florian Schmidt (DG SANTE - European Commission), 🔸 Kim Jørgensen (Permanent representation of the European Investment Bank (EIB)), 🔸 Raúl Martín-Ruiz (Ysios Capital), 🔸 Toon Digneffe (Takeda), and 🔸 Alexander Natz (EUCOPE - European Confederation of Pharmaceutical Entrepreneurs). 📈 At the start of the new European Commission's mandate, the conversation on #EUInnovation and #LifeSciences investment is more timely than ever. 🔗 Read the complete report here: https://lnkd.in/e46gFERR #LifeSciences #Innovation #EUCOPE #PharmaPackage #Investment

🎙“All this translates into an environment of business predictability. I think what would attract investment in this part of the world would be exactly this sense of business predictability.”   🧬Speaking during our second panel on the future development and delivery ecosystem for ATMPs, Francis Pang from Orchard Therapeutics laid out the perspective of small and medium-sized ATMP developers: in order to bring patient access earlier in the global launch sequence, more efforts are required in accelerating approval pathways, broadening reimbursement for ATMPs, and overcoming European fragmentation in the area of value assessment. However, another crucial step centres around cross-border healthcare: many ATMPs are transformative, but have limited therapeutic windows and we need to translate the right to cross-border healthcare into viable access pathways that are not too cumbersome and challenging for patients, clinicians and their resident healthcare systems.   Check out our website for a full report of the discussions our panelists held during the 2024 TRANSFORM MEP Interest Group: https://lnkd.in/e5XfpZRH #MEPsforATMPs #cellandgenetherapy #innovation #HTA #europeancompetitiveness

💡 Now that the 2025 Joint Transnational Call for Proposals is officially out, it’s time for the next step💡Register for our upcoming webinar to get all the essential details. 🚀🔎 👉 We’ll guide you through the application process, clarify eligibility criteria, and share valuable tips to help your proposal stand out! 🗓️ 17 Dec 2024 | ⏰ 14:00-16:00 CET This is a great opportunity to get first-hand information about the call and ensure your application is top-notch. 📝 🔗 Register here: https://lnkd.in/d5xPNS7c #ERDERA #RareDiseases #ResearchFunding

📢 What Drives Life Sciences Investment in the EU and the Future Impact of the Pharma Package? On 14 November, #EUCOPE and FTI Consulting EU launched the report, "The Economic Lens: Understanding What Makes the #EU Attractive for #LifeSciences Investments." This analysis dives into the environment for attracting life sciences investments in the EU and the potential impact of the General Pharmaceutical Legislation (#GPL) revision on investor confidence and industry growth. The event underscored a critical shared understanding: the urgent need to boost the EU's global competitiveness in life sciences. EUCOPE's position is clear: it is vital that the EU remains globally competitive in life sciences, ensuring innovation thrives and patients gain access to groundbreaking therapies. While the #PharmaPackage is a step forward, it still requires key refinements to bridge funding gaps, streamline regulations, and amplify incentives for innovation. 👉 Curious to learn more about the challenges and opportunities ahead? Read the full report and join the conversation about shaping the future for life sciences in Europe. 🔗 Full report: https://lnkd.in/e46gFERR 🔗 Event recap: https://lnkd.in/e8ZZeuKc #LifeSciences #Innovation #EUCompetitiveness #HealthcarePolicy Stine Bosse Raúl Martín-Ruiz Alexander Natz Toon Digneffe

🤝We are looking forward to partnering with World Evidence, Pricing and Access Congress 2025, on 5-6 March 2025 at the RAI Congress Centre, #Amsterdam. 💡Join #EUCOPE's experts to discuss market #access, #pricing, #rarediseases and #innovation. 🌍 The World Evidence, Pricing and Access Congress is Europe’s largest congress in market access, pricing and evidence featuring 300 speakers, multiple streams and over 1200 attendees from #pharma, #biotech and Payers/HTA’s. More information and registration here: 👉 https://lnkd.in/dTusjZX

🚨 Save the date - EUCOPE Webinar - Preparing for EU HTA Joint Clinical Assessments and Joint Scientific Consultations – Practical information to navigate the new procedures   📅Wed. 15/01/2025 🕘 15:00 to 16:00 CET 🛜 Platform: Zoom 👉 Registration: https://lnkd.in/expA4ZiR   📜 From 12 January 2025 the EU HTA Regulation will apply and the first Joint Clinical Assessments (JCA) will be performed to assess the relative clinical effectiveness of new innovative cancer therapies and cell and gene therapies approved by the EMA. In just three years, by 13 January 2028, these joint assessments will also be performed for all new Orphan Medicinal Products (OMPs).   💪 Get prepared ! Join our very own experts Alexander Natz and Matias Olsen on Wednesday 15 January, for a one-hour session. They will explain the final procedural rules that have been adopted in 2024 in the various Implementing Acts and walk you through the procedural steps and the practical guidance documents that have been adopted by the HTA Coordination Group. Participants are invited to ask questions and share their views through a dynamic Q&A session.   📍 Don’t miss this chance to prepare for the new market launch requirements in Europe, register now: https://lnkd.in/expA4ZiR #HTA #JCA #JSC #Webinar #MarketAccess

Yesterday, EUCOPE's Senior Manager, Public Affairs & Policy, Matias Olsen, joined a panel discussion at the 6th European Cancer Forum hosted by MSD. Together with Antonella Cardone and Tuula Helander, they explored the challenges of navigating a changing cancer care system while ensuring the sustainability of healthcare systems. 🔬 #AdvancedDiagnostics facilitate earlier diagnosis of disease, improve prognosis of disease outcome and enable targeted therapeutic interventions. We now have the potential to deliver the right treatment for the right patient at the right time, however challenges around the regulatory processes and reimbursement remain significant barriers for access to genomic testing for patients across Europe. 📈 The European Coalition for Access to Comprehensive #GenomicProfiling (#ECGP) is a multi-stakeholder coalition that works for solutions to provide wider reimbursement coverage for large-scale panels. Comprehensive Genomic Profiling offers substantial advantages in managing molecularly #ComplexCancers, and through increased #GenomicSequencing capacity Europe can achieve the large samples needed to achieve real breakthroughs in #PersonalisedMedicine, #CancerResearch and #RareDiseases. In the coming weeks, ECGP will publish a paper with evidence-based recommendations on how to increase access to CGP in Europe. A heartfelt thank you to MSD for hosting such an impactful forum and to all participants for contributing to this important dialogue. 👉 More information about ECGP: https://lnkd.in/e3js6WGW 👉 More information about the European Cancer Forum: https://lnkd.in/d_x-ASw #EuropeanCancerForum #patients

Pharmaceutical innovators are concerned about not enough advice meetings being offered in 2025 for discussing trial designs and evidence generation plans, with serious ramifications on the ability to undergo #JointClinicalAssessments   Together with Alliance for Regenerative Medicine, EFPIA - European Federation of Pharmaceutical Industries and Associations, EuropaBio - the European Association for Bioindustries and Vaccines Europe, we are concerned that only a fraction of companies submitting for a JCA will be able to discuss their clinical trial plans at the critical planning stage as in 2025 the HTA Coordination Group has only planned for 5-7 Joint Scientific Consultations for medicinal products.   If the #EUHTA Regulation is to successfully deliver on its aims of reducing burdens for companies and speeding up access for patients, it is critical to offer more JSC slots, starting in 2025.   We ask for a solution to be identified urgently and look forward to discussing how #JSC capacity can be increased in 2025 and beyond. All options should be considered including introducing a fee-paying system to provide sufficient resources to support additional advice meetings as well as the prolongation of the current interim #ScientificAdvice model coordinated by the German HTA body G-BA.