EUCOPE's Sounds of Science
Brought to you by EUCOPE, the European Confederation of Pharmaceutical Entrepreneurs.
EUCOPE's Sounds of ScienceFeb 22, 2023
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 (firstname.lastname@example.org) to learn how to join our MDR/IVDR Focus Group.
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
Rare Disease Day 2023: Improving equitable access and diagnosis for people living with a rare disease
SOUNDS OF SCIENCE - EPISODE 13
This year’s Rare Disease Day comes at a crucial time, weeks before we expect the publication of the pharmaceutical package which will revise the General Pharmaceutical Legislation, Paediatics, and OMP Regulations, which will set the tone for the EU rare disease ecosystem for at least the next 2 decades.
The theme for this year’s Rare Disease Day is equity, so we wanted to take the opportunity to dive into some of these debates and asses what the EU can do in this space, especially against the backdrop of the legislative review.
To breakdown this year’s Rare Disease Day and its importance for addressing the 95% of rare diseases with no treatment, we’re joined by:Simone Boselli, Director of Public Affairs, EURORDIS - Rare Diseases Europe 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@example.com or visit our Rare Disease Hub.
The new EU HTA Procedure: Getting it right to improve patients' access to innovative therapies
SOUNDS OF SCIENCE - EPISODE 12
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 firstname.lastname@example.org
2022 Year in Review: Perspectives & Resolutions from the EUCOPE Policy Team
SOUNDS OF SCIENCE - EPISODE 11
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!
Launch Conditionality: The Impact on Small and Mid-Sized Companies
SOUNDS OF SCIENCE - EPISODE 10
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
Advanced Therapy Medicinal Products (ATMPs): How they will be affected by the General Pharmaceutical Legislation
SOUNDS OF SCIENCE - EPISODE 9
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
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 email@example.com.
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
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 firstname.lastname@example.org.
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.
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
Overcoming Barriers: Improving Access for Rare Disease Patients through Cross-Border Healthcare
SOUNDS OF SCIENCE - EPISODE 6
The Cross-Border Healthcare Directive (Directive 2011/24/EU) marked a milestone for European patients. It created a legal framework for the patient’s right to seek healthcare in another Member State and to be reimbursed. It also provided a legal basis for enhanced European cooperation in key areas of healthcare – including quality and safety, Health Technology Assessment and eHealth, and rare diseases.
On May 12, the Commission published their long awaited evaluation of the Cross-Border Healthcare Directive. The report outlines several areas for improvement, but does not call for a reopening of the Directive, which would be a political decision as well.
As more Advanced Therapy Medicinal Products (ATMPs) have become available across Member States, it is still unclear how the cross-border healthcare framework will make access to such transformative treatment abroad more accessible. In this podcast, we’re addressing a number of complex issues with a lot of terminology so today we’ll be discussing the CBH in a holistic manner. The speakers will be able to clarify between the concept of CBH and the Directive itself.
Joining us on this podcast are:Thomas Bols, Head of Government Affairs and Patient Engagement, PTC Therapeutics Victor Maertens, Government Affairs Manager, EUCOPE
The European Alliance for Transformative Therapies (TRANSFORM) is a multi-stakeholder Alliance that connects Members of the European Parliament (MEPs) and policy-makers with patient groups, medical experts and associations, scientists, researchers, industry actors, networks and other relevant stakeholders. More info at https://transformalliance.eu/
EUCOPE's Position Paper - Cross Border Healthcare for Patients: What can be done?
Learn more about EUCOPE at www.eucope.org
Increasing Access to Genomic Testing in Europe: The role of national genomics initiatives in increasing uptake of Advanced Diagnostics
SOUNDS OF SCIENCE - EPISODE 5
On today’s episode, we’ll be following up last year’s discussion on genomic sequencing, by looking at some of the measures that leading EU Member States have taken to pave the way toward wider access to genomic testing and discuss what else can be done to ensure wider patients access with some very knowledgeable experts as well as some of the world’s leading advanced diagnostics developers.
Our guests today are:
· Richard Charter, Vice President MedTech Market Access - Europe & Asia Pacific, Alira Health. He has 15 years of experience in financial economics, health economics, consulting, market access, and pricing for MedTech companies. Alira Health is an international patient-centric and technology-enabled advisory firm whose mission is to humanize healthcare.
· Caroline van der Meijden, Director of Reimbursement EU, Agendia. Next to a PhD in life sciences she is an expert in Health Technology Assessment (HTA) with experience in both public and private sectors. Agendia is a global leader in innovative genomic technology and diagnostic tests for breast cancer.
· Don Husereau, Health Economist & Adjunct Professor at the University of Ottawa. He does freelance health care research, and works with private and public sector life sciences organizations to help them understand the value of health technology and its implications for health and innovation policy.
· Matias Olsen, Public Affairs and Policy Manager at EUCOPE. Matias supports EUCOPE on key topics, covering among others, EU HTA, advanced diagnostics, the Pharmaceutical Strategy, EU’s cancer plan, blood, tissues and cells legislation and relevant market access topics. He coordinates members’ thematic working groups, including the P&R/Market Access Working Group, the Genomics Working Group and the EU HTA Regulation Task Force.
If your company is interested in joining and contributing to our Genomics Working Group, please send an email to email@example.com
What's next for EU Rare Disease Legislation? Its potential implications for patients and pharma entrepreneurs
SOUNDS OF SCIENCE - EPISODE 4
In today’s episode, we discuss upcoming developments in the field of rare diseases, a timely matter as Rare Disease Day approaches on 28 February. Rare disease is a topic which is very close to the heart of our organisation, as almost half of our 130 members work in the field of medicines for rare diseases, also called orphan medicinal products or orphan drugs.
Rare diseases have an important place on the EU agenda, with the French presidency positioning it as one of their priorities plus there continues to be an increasing level of work at the EU level to foster research and clinical excellence in this field. Most importantly for our case, the upcoming revision of the EU orphan medicinal products. Today we want to give you a little more detail on the background of this revision, as well as the possible outcomes and implications for the rare disease community.
Our guests for today:Rachel Finnegan, Head of Government Affairs, BioMarin EMEA Vittoria Carraro, Associate Director for Government Affairs, EUCOPE
EUCOPE is Europe’s trade body for small to medium-sized innovative companies working in the field of pharmaceuticals and medical technologies.
Based in Brussels, Belgium, EUCOPE gives voice to more than 900 research-oriented innovative companies and associations active in research, development of pharmaceuticals, biotechnologies and medical devices. Many of our 130 members are developing therapeutic solutions for persons living with a rare disease, who had little to no treatment available just a few years ago.
Our website: www.eucope.org
The European Pharmaceutical Strategy: A patient-centred and future-proof framework?
SOUNDS OF SCIENCE - EPISODE 3
A lot is currently happening in terms of health policy and discussions around how to organise our healthcare systems. The European Commission's proposal for a Pharmaceutical Strategy certainly holds a lot of potential, however, what can be done to make this initiative a real catalyst for a patient-centred and future-proof framework?
A transparent and dynamic Q&A with EUCOPE in-house experts Victor Maertens and Matias Olsen.
Fostering an EU Advanced Diagnostics Ecosystem
SOUNDS OF SCIENCE - EPISODE 2
In our 2nd episode, we will discuss the promise of advanced diagnostics, for personalised medicine, for the benefits of patients and healthcare systems at large. And we will discover what remains to be done for the EU to lead in this exciting field. #AdvancedDx
A Future-proof HTA System in Europe?
SOUNDS OF SCIENCE - EPISODE 1
While the European Commission proposal for a HTA Regulation set the basis for a streamlined and harmonised approach towards HTA, the recent Council compromise text somehow dashed hopes of many HTA experts. How is it different from the initial EC proposal and why it is a matter of concern? How will it impact the small and medium-size companies and the patients they serve?
Where do we go now? What do we want? How can we ensure the HTA system is future-proof, adapted to the next technologies (OMP, ATMPs, Digital Health, etc…)?
A transparent and dynamic Q&A with high-level experts Ana Palma, SOBI and Alexander Natz, EUCOPE.
Sounds of Science - Trailer
A short introduction to EUCOPE Sounds of Science, a new series of podcast focusing on important EU policy files in the field of health and pharmaceuticals.