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.
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, Senior Associate 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 email@example.com.
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
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 firstname.lastname@example.org
What's next for EU Rare Disease Legislation? Its potential implications for patients and pharma entrepreneurs
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?
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.