Healthcare Council meets in Brussels
The European health experts on EuropaBio’s Healthcare Council also convened in Brussels in late June to discuss recent developments. One topic on the agenda was the decisions of the EU Council from 17 June. These make clear that a review of the European legal basis for the development and approval of medicinal products should be subject to more concrete scrutiny. In addition, the Sub-Working Group on Orphan Drugs reported on the EU Commission’s efforts in this area to further flesh out the term “comparability”. Another topic touched upon was the stakeholder dialogue meetings that have been on the rise since the beginning of the year. Here the ATMP Regulation, the Orphan Drug Regulation and the shaping of the Clinical Trials Regulation in Europe were discussed in greater detail with participants.