Commission proposes EU pharmaceutical reform

After several delays, the European Commission finally published its proposal for the reform of EU pharmaceutical legislation on 26 April 2023.

The long-awaited proposal sets out a comprehensive reform of pharmaceutical legislation through the introduction of both a new directive and a new regulation. A key element of the Commission’s proposal is the introduction of a scheme for data protection and market exclusivity, which makes the length of the exclusivity period conditional on the fulfilment of certain criteria, while reducing the previous standard period.

The official proposal has been met with criticism from some pharmaceutical market operators, with the EFPIA stating that the “proposal manages to undermine research and development in Europe while failing to address access to medicines for patients.” On the other hand, some operators have welcomed the proposal as a positive precedent for further reform on access to medicines.

Setterwalls looks forward to seeing how this develops and is continuing to monitor the process.