Urgent Call to Action for EU Clinical Trials Strategy

The European Federation of Pharmaceutical Industries Associations (EFPIA) warns of Europe’s declining clinical trial opportunities. It stresses the need for the EU clinical trials strategy to tackle these issues. Since 2013, Europe has lost 60,000 trial spots, with trials shifting to the U.S. and China due to better regulations. EFPIA calls for quick action on the EU’s Life Sciences Strategy to fix fragmented rules and revive trials.

Key Insights
Europe’s clinical trials sector faces major challenges. Research is moving to regions with simpler regulations. EFPIA notes that inconsistent CTR implementation and high administrative burdens are key barriers. Stakeholders urge a unified regulatory system and multi-country trials to keep research in Europe. This aligns with the EU clinical trials strategy.

Background Context
EFPIA pushes for policy reforms like harmonized reviews and stronger IP protection. The EU’s Life Sciences Strategy supports multi-country trials and collaborative research. Past efforts, like the CTR, have not stopped the trial decline.

Implications
Fewer trials risk patient access to new therapies and hurt Europe’s global healthcare role. The Life Sciences Strategy must be implemented fast to protect research, especially for ATMPs. Without reforms, health systems may face fewer treatment options which could harm health outcomes and economic competitiveness. Less trial activity may also strain public spending and delay cost-effective therapies. For more details, see EFPIA’s article on the EU clinical trials strategy.