In November 2023, Prescrire contributed to a hearing held by the French Senate's Committee for European Affairs as it prepared a resolution on the European Commission's revision of pharmaceutical legislation (also known as the "pharmaceutical package").

Various issues were discussed, in particular: drug shortages, marketing authorisations, drug dispensing, and incentives based on regulatory data exclusivity.

In January 2024, Prescrire followed up the hearing with a written submission on matters linked to supply issues and drug shortages: measures to support reshoring and thus strengthen health sovereignty, the requirement for pharmaceutical companies to hold contingency stocks, and compulsory licensing.

In October 2024, the Committee for European Affairs adopted the draft resolution, and it was approved by the Senate in December (1). The resolution incorporates a number of Prescrire's key demands, in particular:

• Rejection of the proposed shortening of the European Medicines Agency (EMA) evaluation period for marketing authorisation applications from 210 days to 180 days;
• Rejection of the proposed removal from the definition of an orphan drug that, without this status, developing the drug would be unprofitable;
• Transparency about the costs of pharmaceutical research and development, to include clear reporting of any research tax credits received;
• Rejection of the proposal to scrap risk management plans for generic and biosimilar drugs;
• Rejection of the proposed introduction of "transferable exclusivity vouchers", which are intended to encourage the development of high-priority antimicrobial drugs, but have the potential to substantially increase spending on other medicines by extending the duration of the market monopoly for highly profitable drugs.

References
1- Sénat "Résolution européenne (…) révision de la législation européenne (…)" 29 November 2024: 18 pages.

 ©Prescrire 1 June 2025

Source: "French Senate resolution on the European 'pharmaceutical package'" Prescrire Int 2025; 34 (271): 167. FREE.