Early Access Program In France: How Much Of An Opportunity Is It?

By Henri Leleu, MD, PhD, Martin Blachier, MD, MPH

France has long been a leader in providing early access to innovative medicines through its ambitious Early Access Program (EAP). However, a recent major reform has introduced stricter eligibility criteria, increased financial risks for manufacturers, and mandated burdensome real-world data collection. With a noticeable drop in approval rates in 2024, the crucial question is whether the program still represents a viable opportunity or has become a bureaucratic maze. For pharmaceutical companies looking to bring life-saving treatments to French patients, understanding this shifting landscape is paramount to navigating the path to access.

Read the full article to learn about the current structure of France's EAP and what the recent changes mean for the future of early drug access.