EUCOPE’s Sounds of Science Podcast – Episode 18 The Revision of the General Pharmaceutical Legislation: European Parliament Reports In this episode of Sounds of Science, we explore the ongoing Revision of the General Pharmaceutical Legislation (GPL). On 10 April,  the European Parliament adopted their reports (Directive and Regulation) on the Revision of the GPL, less than a year after the Commission’s proposal was released. In this episode, not only we discuss the proposals adopted by the Parliament, but we compare them with the Commission’s approach, focusing on the incentives framewor ..read more

On 25 April 2024, EUCOPE signed a Joint Statement on the European Commission’s Initiative “Boosting Biotechnology and Biomanufacturing in the EU”, together with key industry associations and organisations representing biotechnology across sectors. While focusing on the entire biotech sector, the Communication recognises the important role of health biotech in boosting EU competitiveness and innovation. This is a step in the right direction to strengthen the EU biotech sector, and in particular small to mid-sized pharmaceutical biotech. “After identifying the existing challenges, we are now lo ..read more

On 24 April 2024, EUCOPE was officially announced as a member of the Critical Medicines Alliance (“Alliance”). The Alliance is a consultative mechanism which brings together relevant stakeholders to identify priorities for action and propose solutions to better prevent and combat shortages of medicines, and to strengthen the supply of critical medicines in the European Union (EU). Since the publication of the Commission’s Communication on Addressing medicines shortages in the EU, EUCOPE has firmly advocated for a nuanced and holistic approach to address shortages and strengthen supp ..read more

Today, 24 April 2024, the European Parliament adopted the provisional agreement on the European Health Data Space (EHDS) Regulation. The compromise text was already endorsed by COREPER on 22 March, but still requires formal adoption by the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO). After both Institutions have completed the legislative procedure, the new Regulation will be formally adopted. The EHDS aims at allowing individuals faster and easier access to and control over their personal electronic health data (primary use). It will also allow certain health data t ..read more

On 10 April 2024, the European Parliament adopted the two reports on the Revision of the EU General Pharmaceutical Legislation, namely the Directive on medicinal products for human use and the Regulation on authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency. Establishing the position of the European Parliament, the reports set out reforms of the EU pharmaceutical landscape, aiming at enhancing access, affordability, and availability. While the Parliament has clearly tried to strike a balance to foster innovation and competit ..read more

In April 2024, the Alliance for Regenerative Medicines (ARM), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), the European Association for Bioindustries (EuropaBio) and Vaccines Europe stated their shared and serious concerns over the workability of the draft Implementing Act for the new EU HTA procedure. The draft Implementing Act (IA) on Joint Clinical Assessment (JCA) of medicinal products, prepared by Member States’ “Comitology” Committee on Health Technology Assessment (HTA) with the suppo ..read more

On 20 March, the European Commission’s published the Communication on Building the future with nature: Boosting biotechnology and biomanufacturing in the EU, proposing a series of targeted actions to boost biotechnology and biomanufacturing in the EU. While focussing on the entire biotech sector, the Communication dedicates an important space to health biotech. EUCOPE sees the Communication and its objectives as a step in the right direction to strengthen the EU biotech sector. It is important that the Commission’s initiative recognises a thriving EU biotech ecosystem is of strategic importan ..read more

on ENVI reports on the EU Pharmaceutical Package Today, 19 March 2024, the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) adopted the two reports on the so-called EU Pharmaceutical Package, namely the Directive on Medicinal products for human use and the Regulation on Authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency. The reports build on the proposal made by the European Commission to reform the EU pharmaceutical landscape to improve access, affordability and availability, while ma ..read more

Negotiators from the European Council and the European Parliament reached a provisional agreement on the EHDS in the early morning of Friday, 15 March 2024. The outcome aims to secure better healthcare across the EU by giving citizens full control over their health data and opening up datasets for research and innovation purposes. The agreement still needs to be formally adopted by the Council and Parliament. The agreement should establish clearer rules for the use of health data for better healthcare delivery, research and innovation. Citizens and patients should be able to enjoy faster and s ..read more

EUCOPE as part of a coalition of 35 large health stakeholder organisations representing patients, health professionals, researchers and industrial actors in the healthcare ecosystem at both European Union (EU) and Member State level, is expressing its shared concerns about the latest negotiations on the proposed Regulation on the European Health Data Space (EHDS). The EHDS is currently being negotiated at speed by EU institutions to get it ‘over the line’ before the end of this political term. There is a real desire by the health stakeholder community for this proposed legislation to be a suc ..read more