EU’s founding father Jean Monnet is widely quoted for saying that “Europe will be forged in crisis and will be the sum of the solutions adopted for those crises”. The regulation of medicines across the Union seems to have followed this logic.
Developed in 1965, the first EU pharmaceutical legislation was a response to the tragic consequences that the use of the drug thalidomide had in thousands of infants during the 1960s. More than 50 years later, the lessons from the COVID-19 pandemic triggered the formation of a “European Health Union” with the pharmaceutical package providing the last piece of the new EU health architecture.
Published by the European Commission last 26 April 2023, this proposal to review the EU pharmaceutical legislation European Commission has been awaited for long by EPHA, its members, and many other stakeholders. While we are yet to analyse and react to the contents of the new proposed Regulation and Directive (which are around 400 pages long), this month’s top stories explore a few elements deserving an early welcome. Among these are the recognition of the role that academia and non-for-profit entities have on the development of innovative therapies and the increased attention to prevent and deal with shortages of medicines, a pre-existing issue that became even more evident during the pandemic. We also look at a first, yet very timid step towards transparency of pharmaceutical R&D costs.
The past 3 years undoubtedly left a mark on this landmark package. It is now up to the co-legislators in the European Parliament and the Council to develop the Commission’s proposals with patients and people at heart. Making medicines affordable and equitably accessible across the EU is still a work in progress.
Further feedback from EPHA and its members on the proposal will be coming soon. Meanwhile, I hope you will enjoy this newsletter!