The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and European Federation of Pharmaceutical Industries and Associations (EFPIA) have concerns on the current direction of the implementation of the EU HTA Regulation. We are firmly convinced that the input from patient organizations, healthcare professionals, industry and HTA experts and… read more
On 13 October 2022, Alexion held a high-level conference, as part of the “Rare Conversations” event series, on rare disease policies at the Bibliotheque Solvay in Brussels. Alexion’s recent conference in Brussels, Rare Disease Policies 2022, was an insightful look into the possibilities for the… read more
Sounds of Science Podcast – Episode 9 Advanced Therapy Medicinal Products (ATMPs): How they will be impacted by the General Pharmaceutical Legislation On our latest episode, we explore the topic of Advanced Therapy Medical Products, or ATMPs. This covers a wide range of therapies, but… read more
On September 5, 2022, the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and Bundesverband der Pharmazeutischen Industrie (BPI) organised an online event on the revision of the EU regulatory framework for orphan drugs and its impact on Germany. The upcoming revision was discussed together with patient… read more
Sounds of Science Podcast – Episode 8 Ensuring a Robust European Health Data Space (EHDS) On 3 May 2022, the European Commission published the proposal for a regulation introducing the European Health Data Space (or EHDS). The proposal aims to enable better exchange and access… read more
Sounds of Science Podcast – Episode 7 Unmet Medical Needs (UMN): Towards a new understanding with a focus on underserved areas The topic of unmet medical needs (UMN) is quite high up on the agenda in European health policy these days. Recent literature has identified… read more
The objective of this survey is to capture the consequences of the Medical Devices Regulation (MDR) on innovative European companies, including those that have received significant government money. We expect that a contradiction could emerge between the massive investment done by the EU and Member… read more
Sounds of Science – Episode 6 Overcoming Barriers: Improving Access for Rare Disease Patients through Cross-Border Healthcare 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… read more
As the science around genomics continues to evolve, advanced diagnostics technologies are delivering benefits to today’s patients while supporting future research and clinical development. However, beyond research programmes, many of these technologies are not reaching patients in clinical routine care in Europe. Patients’ health outcomes… read more
EUCOPE’s latest position paper outlines our vision for the evolution of the EU Regulatory framework and a modernisation of the Centralised Procedure to ultimately bring novel medicines earlier to patients. The European Centralised Procedure (CP) has helped and accelerated the approval of novel medicines across… read more
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