Legislative Train Schedule
European Parliament
Please fill in this field to search

Revision of the EU pharmaceutical legislation

In “Promoting our European Way of Life”

PDF version

On 26 April 2023, the Commission put forward a 'pharmaceutical package' to revise the EU pharmaceutical legislation and make medicines more available, accessible and affordable; whilst also supporting competitiveness, attractiveness, and higher environmental standards of the EU pharmaceutical industry. The package includes a proposal for a new directive (2023/0132(COD) and a proposal for a new regulation (2023/0131(COD)), which together replace the existing pharmaceutical legislation, including the legislation on medicines for children and for rare diseases (orphan drugs). The 'package' also included a recommendation to step up the fight against antimicrobial resistance (AMR) that was adopted by the Council on 13 June 2023.

On 24 October 2023, the Commission published a communication on addressing medicine shortages in the EU. 

The European Economic and Social Committee adopted its opinion on the two legislative proposals on 25 October 2023. 

In the European Parliament, the files have been allocated to the Committee on Environment, Public Health and Food Safety (ENVI). The rapporteurs were Pernille Weiss-Ehler (EPP, Denmark) for the proposed directive and Tiemo Wölken (S&D, Germany) for the regulation. The ENVI Committee adopted its reports on the two proposals on 19 March 2024.

On 10 April 2024, the European Parliament adopted the ENVI reports as Parliament’s negotiating position without amendments - with 495 votes in favour, 57 against and 45 abstentions for the proposed directive; 488 votes in favour, 67 against and 34 abstentions for the proposed regulation. Parliament reiterated its support to a comprehensive reform of the pharmaceutical legislation. It called for ensuring safe, efficient and quality medicinal products, fostering innovation and development of medicines to address unmet medical needs, and to boosting research in new medicines to fight antimicrobial resistance.

European elections took place in June 2024. The Committee on Public Health (SANT) was established as a standing committee (when the European Parliament voted to upgrade the existing ENVI Subcommittee on Public Health to full committee status) on 18 December 2024. Dolors Montserrat (EPP, Spain) succeeded Pernille Weiss-Ehler as rapporteur for the proposed directive, while Tiemo Wölken (S&D, Germany) remains rapporteur for the proposed regulation.

On 3 June 2025, SANT Committee voted in favour on the decision to enter into interinstitutional negotiations. The Council adopted its negotiating position on 4 June 2025. Trilogues began on 17 June 2025. A second one followed on 7 October 2025, and a third on 11 November 2025. The final one took place on 10 and 11 December 2025. 

The co-legislators reached a provisional agreement on 11 December 2025, which now needs to be approved by both the Council and Parliament, before being formally adopted. According to the provisional agreement, there would be for companies placing a new medicine on the market a period of eight years of data protection (during which competitors cannot access product data) and one year of market protection (during which generics or biosimilars cannot be sold). Additional 12-month extensions would be granted notably to medicines addressing unmet medical needs, medicines containing new active substances meeting clinical trial criteria, or bringing significant clinical benefits in new therapeutic indications. The total protection would be capped at 11 years total. Breakthrough orphan drugs (addressing a disease with no current available medicinal treatment) would receive up to eleven years of market exclusivity. To step up the fight against antimicrobial resistance, a new 'transferable 12-month data exclusivity voucher' would target companies developing 'priority antimicrobials'. This voucher would grant companies one additional year of market protection for a pharmaceutical product of their choice. New rules would mandate compulsory prescriptions for all antimicrobials, specific info in patients' leaflets, and an 'awareness card' (paper format if the leaflet is provided electronically). To ensure the availability of key medicines, companies would be obliged to maintain and update shortage prevention plans for critical products; shortages would be monitored nationally and at EU level, with the European Medicines Agency listing critical ones facing shortages.

References:

Further reading:

Author: Laurence Amand-Eeckhout, Members' Research Service, legislative-train@europarl.europa.eu

As of 20/02/2026.