EUCOPE's Sounds of Science

• The Revision of the General Pharmaceutical Legislation: European Parliament Reports

  EUCOPE's Sounds of Science - Episode 18 On this episode, we talk about the revision of the General Pharmaceutical Legislation (GPL). We discuss the reports adopted on 10 April by the European Parliament, less than a year after the Commission’s proposal was released, focusing on the incentives framework and the regulatory provisions. Not only we will discuss the proposals adopted by the Parliament, but we’ll compare them with the Commission’s approach. We will also share our thoughts on how the revised framework might impact small and mid-sized companies and their investments in innovative treatments in Europe.   The guests of this episode are: Victor Maerterns, EUCOPE’s Government Affairs Director. Dr Seán Byrne, EUCOPE’s Senior Manager Legal and Regulatory Affairs. Stefano Romanelli, EUCOPE's Senior Government Affairs Director.

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• Real-World Evidence (RWE): The need for a multi-stakeholder approach

  SOUNDS OF SCIENCE - EPISODE 17 On this episode, we explore the topic of Real-World Data and Real-World Evidence – that is data that is collected in a real-world setting, such as in healthcare institutions rather than through controlled experiments. We examine how and why this information can be useful for biopharma companies and health authorities, in order to bring new innovative therapies to patients. We will also look into some of the challenges with using this type of data, and view how a multi-stakeholder initiative - RWE4Decisions - is tackling those issues. Our special guests include: Karen Facey, Senior Advisor HTA, RWE4Decisions Carlos Martin Saborido, Scientific Officer, Spanish Ministry of Health Alexander Natz, Secretary General, EUCOPE =================================================================================================================== For more information on EUCOPE’s initiatives with Real-World Evidence or how your organisation can contribute to it, please contact Matias Olsen [email protected] If your company would like to put forward a topic for us to discuss or to participate in a future podcast episode, please reach out to our producer, Dante Di Iulio.

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• Rare Reflections: Impact of the OMP revision on rare disease companies in Europe

  EUCOPE's Sounds of Science - Episode 16 On today’s episode, we explore the revision of the Orphan Medicinal Products (OMP) Regulation as part of the Pharmaceutical Package, and its impact on small and mid-sized pharmaceutical companies, the key drivers of innovation in Europe. We’d like to deep-dive into the implications of specific Commission proposals, and how innovative pharmaceutical companies see the introduction of concepts such as high unmet medical need as the basis for a modulated incentive framework. EUCOPE is no stranger to proposals to modulate the orphan incentive, having worked with the multi-stakeholder Expert Group on Orphan Drug Incentives to establish an alternative model, and today’s guest played an important role in developing that approach. Building on the success of the past 20 years, and establishing a system that continues to drive research, and crucially address the 95% of rare diseases that have no established treatments is no small task. This requires creative and alternative solutions, and small and mid-sized innovative pharmaceutical industry is keen to play its role. To help us understand the impact of this review, and how the European Innovative pharmaceutical industry sees the current proposal, we’ve got two rare disease experts joining us today: Diego Ardigò, Head of Research & Development, Chiesi Global Rare Diseases Alexander Natz, Secretary General, EUCOPE ============================================================================================================= For more information on EUCOPE’s efforts on rare diseases and orphan drugs or how your organisation can contribute to it, please contact Victor Maertens [email protected]

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• MDR/IVDR: Recent changes and their implications for EU medical device companies

  SOUNDS OF SCIENCE - EPISODE 15 On today’s episode, we focus on the EU’s Medical Device Regulation (MDR) which came into full effect on 26 May 2021 and followed by the In Vitro Diagnostic Device Regulation (IVDR) the following year. The idea of both regulations is to balance the regulatory review and approval processes of medical devices and IVDs across all EU Member States, essentially harmonizing the European market for medical devices. However, the Medical Device Regulation is causing some problems, and stakeholders and politicians at both the national and EU levels are warning that the MDR is leading to potential medical device shortages, and even medical devices disappearing from the EU market as a whole. In short, the main problem is that under the MDR, all medical devices produced in Europe must be re-certified. Re-certification needs to be done by a notified body, which is a national organisation designated by an EU country to assess the conformity of devices placed on the market. The main reason for the shortages is the capacity of these notified bodies to recertify. There are currently only 36 notified bodies with 23,000 certificates that need to transfer very much at the same time. Also, most manufacturers are not prepared for the new and sometimes costly rules of the MDR. In light of all this, and primarily to prevent the imminent risk of shortages, the European Commission decided to amend the medical device and in vitro diagnostic regulations. To help us breakdown the recent changes and what it means for EU medical device companies, we’re joined by three experts in the medical devices space: Jörg Plessl, Head of Global Regulatory Affairs, Norgine Megan Doyle, Director, Global Regulatory and R&D Policy, Amgen Axel Korth, Sr. Legal and Regulatory Affairs Advisor, EUCOPE  --------------------------------------------------------------------------------- If you're a medical device company looking to add your voice to the ongoing debate and need help navigating the complex EU medical device market, please reach out to EUCOPE's Leander Vranken ([email protected]) to learn how to join our MDR/IVDR Focus Group.

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• Trans-Atlantic Innovation : Building bridges between the EU and US life sciences industry

  SOUNDS OF SCIENCE - EPISODE 14 With the passing of the Inflation Reduction Act, significant changes are coming for drug pricing and payment in the United States. At the same time, the upcoming revision of the EU Pharma Package will have a significant impact on the competitiveness and predictability of the EU biopharmaceutical landscape. There are several gaping differences between the biopharma ecosystems of the US and the EU. For instance, it takes on average 150 days longer to get an innovative medicine approved in Europe than in the US – time that could be crucial for some patients. To understand what is happening in policy and regulatory developments in both the EU and US markets and how they will impact biopharmaceutical innovation for the foreseeable future, our latest podcast gathers first-hand perspectives from our American counterparts and details how we can work together to build trans-Atlantic bridges for innovation in life sciences. Our special guests include: Justin Pine, Senior Director, International Affairs – Global IP and Data Policy, Biotechnology Innovation Organization (BIO) Ben Bradford, Vice President of Economic Development & Workforce, MassBio Alexander Natz, Secretary General, EUCOPE ============================================================================== Join EUCOPE at the BIO International Convention from 5-8th June in Boston, Massachusetts to Stand up for Science. Register here

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