“Current legislation on clinical trials is not delivering the expected results and needs to be urgently revised”, European Commissioner for Health Olivér Várhelyi pleaded during an informal meeting of European health ministers in Copenhagen on Tuesday, 16 September.
The commissioner pointed out that Europe was losing ground to other regions in the world, which is causing innovation to decline, making it more difficult to access treatment, and weakening healthcare systems. In his opinion, multinational clinical trials should be strengthened so that no country is left out of clinical research.
The European Commission also emphasised that the EU was still too slow to approve trial applications, including those for multinational trials—and this despite the implementation of the Clinical Trials Regulation (536/2014). Having come into force on 31 January 2022, this legislative text aims to harmonise and expedite procedures through a single portal, the Clinical Trials Information System.
In this context, future biotechnology legislation is expected to play a role in making the EU more attractive for clinical research and in strengthening its competitiveness against the United States and Asia (see EUROPE 13673/13).
The discussion among ministers reportedly showed that multinational clinical trials enable smaller Member States to access cutting-edge treatments and provide a larger pool of patients for trials (some of which are currently delayed due to an insufficient number of participants).
The ministers reportedly touched on the challenge of harmonising the examination of clinical trial applications among Member States, in particular for ethical approval (a single ethics body per country and improved national expertise), to a greater extent and mentioned developing mutual trust among national authorities and sharing information and best practices.
However, the ministers reportedly acknowledged that it remains difficult to harmonise ethics due to social, cultural, and legal differences, since this area of competence is still largely a national matter.
The European Health Data Space (EHDS), which is in the process of being implemented, is expected to make it easier to share clinical trial results and to help strengthen cooperation among Member States.
Danish Minister for Health Sophie Løhde stressed that it was necessary to “tak[e] action to secure a more robust life science sector in Europe and underpin a modern and effective healthcare system”.
Finally, the ministers discussed ways to combat the growing threat of antimicrobial resistance. (Original version in French by Lionel Changeur)