13 episodes

Helping you get acquainted with the most pressing EU policy files on pharmaceuticals and biotechnologies.

Brought to you by EUCOPE, the European Confederation of Pharmaceutical Entrepreneurs.

Sounds of Science EUCOPE

    • Science

Helping you get acquainted with the most pressing EU policy files on pharmaceuticals and biotechnologies.

Brought to you by EUCOPE, the European Confederation of Pharmaceutical Entrepreneurs.

    The new EU HTA Procedure: Getting it right to improve patients' access to innovative therapies

    The new EU HTA Procedure: Getting it right to improve patients' access to innovative therapies

    With the entry into force of the EU HTA Regulation in January 2022, the European Commission and EUnetHTA21, a consortium of Member States HTA bodies, have been racing to develop the procedural rules and the methodology for EU Health Technology Assessment (HTA). This is before the first medicinal products will be subject to the new procedure starting 12 January 2025.

    The new EU HTA procedure will significantly change the requirements before placing innovative medicinal products on the market, with certain new products having to go through a joint European assessment as a first step. On today’s episode, we’ll review what’s happened in the final drafting stages that took place over the course of 2022 and if this new procedure will replace the fragmented patchwork of national frameworks that currently exist, or if it will only represent yet another step in the process. It's crucial to get this procedure right at the first go in order to speed up patients' access to innovative therapies.

    To help us do so, we’re joined by two EU HTA experts:


    Ana Palma, Senior Director Global Patient Access & Access Policy, Sobi
    Alexander Natz, Secretary General, EUCOPE

    _____________________________________________________________________

    EUCOPE's EU HTA Regulation Task Force has been set up to more closely coordinate with members on the engagement with the European Commission and EUnetHTA 12 for the development of the procedural rules and methodology respectively. For more information on how your organisation can contribute to it, please contact Matias Olsen olsen@eucope.org

    • 20 min
    2022 Year in Review: Perspectives & Resolutions from the EUCOPE Policy Team

    2022 Year in Review: Perspectives & Resolutions from the EUCOPE Policy Team

    Throughout 2022, there have been successes, challenges, delays and change within the European pharmaceutical industry and we expect more to come in 2023. On the final episode of the year, hear the EUCOPE Policy team - Victor Maertens, Matias Olsen and Leander Vranken - unravel the past year in European pharma and biotech, looking at everything from rare diseases to ATMPs to EU HTA to Digital Health, sharing key highlights and what to expect in 2023.

    We will be back with more amazing episodes and insights next year, so stay tuned and stay healthy!

    • 31 min
    Launch Conditionality: The Impact on Small and Mid-Sized Companies

    Launch Conditionality: The Impact on Small and Mid-Sized Companies

    Within the European Commission’s ongoing review of the General Pharmaceutical Legislation and Orphan Medicinal Products (OMP) Regulation, there are several potentially controversial policy options that aim to enhance access to medicine and overcome unmet medical need, including launch conditionality. Under the proposed system, companies would only receive their full Regulatory Data Protection if they meet a number of predefined conditions.

    Two conditions under consideration are that companies must launch the product in most, if not all, EU Member States within a fixed timeframe and address a yet unspecified unmet medical need. Today’s discussion focuses on the launch condition, which is far-reaching and creates additional risk for small and mid-sized companies to launch products – particularly orphan medicinal products (OMPs) – in the EU.

    Small and mid-sized companies are key drivers of biopharmaceutical innovation in Europe. They play an important role in the development of new and underserved medicines, so it is crucial that their needs and interests are looked after in order to reinforce an innovative and competitive biopharmaceutical ecosystem in Europe. The EU should avoid implementing policy that discourages innovation, disproportionally punishes small and mid-sized companies and might limit, not improve access.

    To understand the potential impact of the launch condition on the small and mid-sized health technology company, we’ve invited two of our members on the show today:


    Johanna Grames, Senior Manager for International Governmental Affairs and Health Economics at AOP Health
    Thomas Bols, Government Affairs Manager, PTC Therapeutics
    Alexander Natz, Secretary-General, EUCOPE

    • 37 min
    Advanced Therapy Medicinal Products (ATMPs): How they will be affected by the General Pharmaceutical Legislation

    Advanced Therapy Medicinal Products (ATMPs): How they will be affected by the General Pharmaceutical Legislation

    On today’s episode, we will be exploring the topic of Advanced Therapy Medical Products, or ATMPs. This covers a wide range of therapies, but we’ll be using it as shorthand for gene and cell therapies for today’s conversation.

    ATMPs have been receiving significantly more attention in recent years as a growing number of them come to market. As a potentially one-off, transformative treatment, these therapies are different from many therapies currently available or in development. However, much like all other therapies, ATMPs will be impacted by the ongoing review of the General Pharmaceutical Legislation, and many cases, the review of the OMP regulation as well. Beyond the legislative and regulatory framework, interesting developments are also taking place with regard to HTA and P&R. This combination of commercial and legislative developments will have long-term implications on ATMPs and the competitiveness of the EU.

    Suffice to say, there is a lot happening when it comes to ATMPs, and with the help of today’s guests, we hope we can start to unpack a few of these discussions, and possibly look into the future as well.

    Today's guests are:


    Dr Lutz Bonacker, Senior Vice President and General Manager, Commercial Operations Europe, CSL Behring
    Dr Alexander Natz, Secretary General, EUCOPE

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    For more information about our work on ATMPs or how to join our Cell & Gene Therapy Working Group, simply visit our website or send an email to maertens@eucope.org.

    • 38 min
    Ensuring a robust European Health Data Space (EHDS): Working to create a fit-for-purpose regulatory framework

    Ensuring a robust European Health Data Space (EHDS): Working to create a fit-for-purpose regulatory framework

    SOUNDS OF SCIENCE - EPISODE 8

    On 3 May 2022, the European Commission published the proposal for a regulation introducing the European Health Data Space (EHDS). The proposal aims to enable better exchange and access to different types of health data (think about genomics data, data from patient registries, electronic health records, etc.).

    And what does it want? Well, It intends to create a common space where natural persons can easily control their data which should enable individuals to gain better digital access to their personal health data and support free movement. This is commonly referred to as the primary use of data.

    It also allows for the secondary use of data, meaning that the EHDS makes it possible for researchers, innovators and policymakers to use electronic health data of Europeans in a trusted and secure way.

    EUCOPE welcomes the proposal on the European Health Data Space. It also recognises the importance of EU-level data collection standards and the promotion of data interoperability and exchange protocols. However, such a domain-specific common data space is expected to face challenges. 

    To discuss these challenges and what it will take to deliver on the ambitious promise of the EHDS, we have three of our members as guest today:


    Dan Whitehead, Counsel at HOGAN LOVELLS
    Paul Michaloux, EU Associate Director at HANBURY STRATEGY
    Julie Chauvet, Director EU Public Affairs at NOVARTIS

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    For more information about our work on the European Health Data Space (EHDS) or how to join our Digital Health Working Group, simply visit our website or send an email to vranken@eucope.org.

    • 23 min
    Unmet Medical Needs (UMN): Towards a new understanding with a focus on underserved areas

    Unmet Medical Needs (UMN): Towards a new understanding with a focus on underserved areas

    SOUNDS OF SCIENCE - EPISODE 7

    The topic of unmet medical needs (UMN) is quite high up on the agenda in European health policy these days.

    Recent literature has identified no less than 15 different definitions of unmet medical needs. These include various elements ranging from the absence of therapeutic options to disease burden and severity, just to name a few.

    UMN is not a foreign concept in EU Legislation and national assessment, but now it has become quite central to the discussion on the revision of the Orphan, Paediatric and General Pharmaceutical Legislation.

    We expect proposals for the revision of these pieces of legislation at the end of this year. The European Commission is contemplating the option of defining or including criteria to identify unmet medical needs in the General Pharmaceutical Legislation context and possibly include a concept of high or highest unmet medical needs in the orphan legislation context.

    To help us unpack the ongoing discussion and provide some perspectives on it, we’re joined by:


    Dimitrios Athanasiou, Board Member of the World Duchenne Organization (WDO), European Patients' Forum (EPF) and a member of the Paediatric Committee of the European Medicines Agency (EMA)
    Alexander Natz, Secretary-General, EUCOPE

    This episode is hosted by Vittoria Carraro, Associate Director of Government Affairs at EUCOPE.

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    The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) gives a bigger voice to small to mid-sized health technology companies in Europe. Representing 2600+ innovative biopharmaceutical companies directly or through national associations, EUCOPE advocates for sound public policy that supports innovation, while fostering a community built on a shared purpose: improving and saving the lives of European patients through innovative therapies and medical technology. Learn more at www.eucope.org

    • 34 min

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