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 adop

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 innovativ

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

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, ess

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

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 i

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 1

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 ra

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 r

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 p