EUCOPE's Sounds of Science

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 Parliam...

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 pat...

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 compa...

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...

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...

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 want...

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....

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 A...

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...

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, t...

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...

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 L...

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 Assessm...

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...

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 d...

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&amp...

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

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 ser...

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.