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The European Medicines Agencies (EMA) and Heads of Medicines Agencies (HMA) joint strategy for 2028 marks a pivotal moment for life sciences management. This call for consultation underscores the critical need to adapt to a rapidly evolving medicines landscape, shaped by new legislation, technological innovations like AI, and emerging public health threats. For the life sciences sector, this strategy presents both challenges and opportunities—particularly in improving access to medicines, leveraging digital advancements for efficiency, and fostering a regulatory environment that enhances innovation and competitiveness. As EMA and HMA focus on sustainability, antimicrobial resistance, and medicines availability, the life sciences industry must engage proactively to ensure alignment with these strategic objectives. The consultation offers stakeholders a chance to influence how regulatory frameworks evolve to support cutting-edge advancements while addressing societal health needs. Ultimately, this strategy will shape the future of pharmaceutical development and regulation across the EU, making stakeholder input crucial for driving impactful, forward-thinking change. #regulatorygramwrok#healthneeds#EMA#sciencemanagement#lifesciencesindustry#innovationtechnology#AI#

National Primary Health Care Development Agency (NPHCDA) has collaborated with the National Institute for Pharmaceutical Research and Development (NIPRD) to improve the implementation of evidence-based innovations in the health sector of Nigeria.

🚀 EU HTAR: Assessing national payers' readiness As the European Union Health Technology Assessment Regulation approaches, how prepared are national payers for this major regulatory change? We examined the readiness of EU Member States and the challenges they are facing as the January 2025 implementation date gets closer. 🔍 Read our article to get more insights: http://skp.link/oon Many thanks to Diane Cosset, Vincent Janssen, Eleonora Sirena and Sara Masutti for their contribution to the article, and to all other Health & Pharma colleagues directly or indirectly involved in our EU HTA Center or excellence! #HealthTech #EUHTAR #Pharma #Healthcare #LifeSciences #SimonKucher

🗓️In February, POLITICO Europe will host "The Critical Medicines Act: How can Europe achieve drug supply sovereignty?", an event presented by Teva Pharmaceuticals Adrian van den Hoven, Director General of Medicines for Europe, will participate in a panel discussion. The Covid-19 pandemic revealed weaknesses in the EU's medicines market, from fragile supply chains to insufficient solidarity. The EU Critical Medicines Act aims to secure medicine supplies by diversifying sources and boosting Europe’s production of generics and APIs. What should the Critical Medicines Act prioritize to strengthen supply chains and industrial capacity? Experts will discuss reshoring, market incentives, stockpiling risks, and the role of public tools to ensure Europe’s health resilience. Want to follow the discussion online? Follow this link:

This week I was at #CPHIMilan and participated in a panel discussion with industry colleagues on the European Commission’s #CriticalMedicinesAlliance (CMA), and how we can safeguard the future of medicines. The CMA aims to take steps to strengthen the supply of critical medicines in the EU – of which more than 90% are generics. To overcome medicines shortages, the underlying causes must be addressed, not just the symptoms, and that’s why we need sustainable market conditions. Three key factors must be in balance for market sustainability – to have reliable supply of medicines that are top quality, pricing must be fair. Sandoz will never compromise on quality, so to enable security of supply, pricing and reimbursement systems must be recalibrated to recognize the value of these medicines.   With the Critical Medicines Act on the horizon for 2025, I am hopeful this will be an opportunity for Europe to bring together the final pieces of this complex puzzle so every patient that needs access to these medicines can get them. Medicines for Europe (MfE) has released a vision outlining the sustainable policy frameworks needed by EU off-patent medicines manufacturers – including how we must collectively, as public and private entities, reward and invest in strategies for resilient supply and maintain solidarity across the EU. Be sure to check it out at the link below.   Thank you to my co-panelists Markus Sieger Philippe Drechsle and Roberta Pizzocaro for sharing your perspectives on this important topic. Our collaboration is key to creating a healthier future for patients and society!   MfE's vision for the European Critical Medicines Act: https://lnkd.in/etT5gjPy

🚨Timely news after it was one of the hot topics at last week’s World Orphan Drug Congress Europe (WODC) in Barcelona: The final implementing Act (IA) on the conflict of interest (COI) management for stakeholders within the EU HTA process was now adopted on October 25th by the European Commission, about 5 months after the draft version of the act was published. At the WODC it was highly debated how clinical and patient experts are ought to be involved with manufacturers to support patient-centered and unmet-need-oriented drug development, but at the same time be available and “unbiased” for regulatory and HTA processes – as, especially in the field of rare diseases, those experts are going to be sparsely own. This was also one of our main critique points when commenting the draft implementing act: it was introducing very strict and inflexible rules for the participation of patients and clinical experts (as well as for authority representatives) who were involved with developers in the recent past. That could lead to the exclusion of key stakeholders in JSC and JCA processes. It is therefore with delight that we now see #rare #diseases explicitly mentioned as #exceptional #cases were experts and patients with a supposed COI could still be involved. On the same note, the strict guidelines for determining a present COI found in Annex C of the IA have not changed apart from a few specifications, still potentially impeding the involvement of key stakeholders in a lot of other JSC/ JCA procedures. Finally, it is important for us to point out again that there is still an urgent need for a clear and structured framework for involvement of patients and clinicians as they are currently still in the unknown about in what ways and in what timing they will be able/ required to participating in the upcoming EU HTA related procedures – that has become painfully obvious again in the WODC discussions. If you have any questions about the involvement/ COI of stakeholders in the EU HTA framework, please feel free to get in touch with us. As always, we will keep you posted on all things EU HTA! #EUHTA #JCA #JSC #COI #IA #MarketAccess

Founded in 2016, Medicines for Ireland (MFI) is an established industry voice within the Irish healthcare system. It represents the pivotal role and interests of manufacturers and suppliers of generic, biosimilar, and value-added medicines. With MFI members supplying the majority of medicine in Ireland to the HSE and patients directly, it is committed to effecting real change and reforms that guarantee patients have access to the medicines they need at affordable prices. The significance of a resilient and sustainable generics, biosimilars, and value-added medicines industry cannot be understated, particularly given the mounting challenges posed by escalating medicine budgets, demographic shifts towards an ageing population, and the escalating costs linked with managing chronic diseases and long-term care. Our vision is that all Irish patients can afford and access the medicines they need to get well, stay well, and live well. As an organisation, our core objective is to improve how Ireland procures and supplies medicines to expand patient access to affordable, lifesaving and life-enhancing treatment. #MedicinesForAll Teva Pharmaceuticals Consilient Health Fannin Ltd Fresenius Kabi Clonmel Healthcare Pinewood Healthcare Accord Healthcare Viatris Celltrion Inc

The European Medicines Agency releases draft reflection paper on #RWD in non-interventional studies for #regulatory purposes, addressing methodological aspects and inviting stakeholder input until August 31, 2024. Read at The Evidence Base® #rwe #realworldevidence #realworlddata #regulation #regulatoryaffairs #healthdata #healthpolicy

🇪🇺 The EU Critical Medicines Alliance 🔬 Initiation: Launched in October 2023 by the Belgian EU Presidency and the European Commission, the #CriticalMedicinesAlliance is dedicated to securing a stable medicine supply across the EU. 📆 Inaugural Meeting: The first meeting successfully convened yesterday, the 25th of April, marking a significant step forward in collaborative efforts. 🌍 Global Collaboration: The initiative seeks to echo past EU successes by enhancing strategic autonomy in the production and distribution of medicines, addressing shortages effectively. 🔍 Consultative Platform: This platform is designed to cultivate stakeholder cooperation, tackling challenges in the drug supply chain to propose actionable solutions. 🛠️ Strategic Objectives: The Alliance aims to amplify manufacturing capacities and diversify supply chains, forming strategic partnerships within and beyond the EU. 📈 Future Prospects: High expectations are set for advancing the EU’s healthcare infrastructure, improving access to essential medicines and bolstering economic security. 💊 First version of the Union list of critical medicines: https://lnkd.in/dp_v7tab #EuPharma #PharmaPolicy #CriticalMedicines #EUCriticalMedicines #CriticalMedicinesAlliance #HERA

Ready for 2025? How lessons learned from national system reforms can guide our response to the new EU HTA regulations Join us at ISPOR Europe for an engaging symposium as we prepare for the joint clinical assessment (JCA) launching in January 2025. Moderator: Herbert Altmann, Vice President, Market Access & Healthcare Consulting, Cencora Panelists: - Iga Lipska, Chairwoman of the Board, Health Policy Institute Poland - François Meyer, Independent Consultant - Oriol Solà-Morales, CEO, Health Innovation Technology Transfer - Mihai Rotaru, Director, Market Access, European Federation of Pharmaceutical Industries and Associations (EFPIA) Discover how recent reforms in Germany, Spain, France, and Poland can guide our response to new EU regulations. - Insights into the impact of national HTA processes on access and innovation - Strategies for aligning with EU regulations - A blueprint for improving patient outcomes Join us to discuss the future of healthcare access in Europe: https://ow.ly/Kz8h50U2FJF #ISPOR2024 #EUHTA #PatientAccess #MarketAccess