A new report by the European Federation of Pharmaceutical Industries and Associations reveals a troubling gap in medicine availability across Europe. Overall, only 28% of new medicines are now fully covered by public reimbursement, down from 42% in 2019.
Patients in the fastest countries wait as little as 56 days after authorization, while those in the slowest face delays of over three years. Germany leads with a median wait of just 56 days, followed closely by Switzerland, Serbia, Austria, and Denmark. At the other extreme, patients in Romania must wait 1,201 days-roughly 37 months. Portugal, Lithuania, and Croatia also rank near the bottom.
Availability of innovative therapies and orphan drugs is equally uneven. Germany offers 156 out of 168 novel medicines tracked; Malta offers only 22. Across the EU, Austria, Italy, and Spain show strong numbers, while Latvia, Romania, and Hungary lag.
The report warns that Europe's regulatory process is falling behind globally. Between 2021 and 2025, the EMA approved 231 new active substances, compared to 253 by the U.S. FDA and 296 by China’s NMPA. Notably, 37% of drugs approved by the FDA over the past decade lack EMA approval, suggesting Europe is losing ground in both speed and access.