Swedish life science actors call for EU body for multinational clinical trials

Europe continues to fall behind the US, China, and other countries in the number of clinical trials. The fragmentation of regulations, procedures, and systems makes multinational clinical trials in the EU a challenge. 

The Swedish organisations SwedenBIO, Lif, IKEM, and Swedish Medtech – representing different segments of Sweden’s life science industry – are now calling on the European Commission to take action to address the issue. 

In their joint call for evidence for the new EU life science strategy, they note that conducting multinational trials in Europe remains complex and time-consuming, despite the adoption of the Clinical Trials Regulation (CTR), MDR, and IVDR, particularly for advanced healthcare solutions such as precision medicine. 

“Regulatory fragmentation and a lack of coordination between Member States discourage companies from choosing the EU as a trial location, ultimately weakening Europe’s competitiveness in research and development,” they write. 

To improve the situation, they propose that the upcoming EU life science strategy, expected in 2025, promote effective coordination mechanisms between national ethics committees and regulatory authorities. “It should also establish a binding EU body responsible for approving multinational clinical trials, significantly simplifying and accelerating trial startups across Europe,” they write. 

"Having effective coordination mechanisms between national ethics committees and regulatory authorities, and an EU body with a binding mandate to approve multinational clinical trials, would significantly simplify and accelerate the start of trials across Europe," says Jessica Martinsson, CEO of SwedenBIO. 

 
The call for evidence can be accessed here.