European Institutions Agree On The Reform To The EU Regulatory Framework For Medicinal Products

On 11 December, after overnight interinstitutional negotiations between the European Parliament and the Council of the European Union ("Council") and the European Commission, the institutions reached a provisional political agreement on the reform of the European Union ("EU") pharmaceutical legislation.

This agreement concludes months of trilogue discussions and follows a much longer legislative process that began with the European Commission's proposal adopted in April 2023, the European Parliament's position adopted on 10 April 2024, and the Council's position adopted on 4 June 2025 (see our detailed advisory on the Commission's proposal and our BioSlice blog posts on the Parliament's and Council's positions here and here).

The provisional agreement must now be formally adopted by both the Parliament and the Council.

We set out below some of the key aspects announced so far and will follow-up with a detailed analysis:

• Regulatory data protection: The new standard protection for medicines with new active substance status is nine years: eight years of Regulatory Data Protection ("RDP") and one year of Market Protection ("MP"). Medicines would be eligible for two additional one year periods of MP where they meet certain conditions. There will be a cap of eleven years on the overall protection periods.
• Bolar exemption: The scope of the so called "Bolar" exemption will also be clarified. It will be made clear that certain activities preliminary to launch and sale would not be an infringement of patent protection, including conducting health technology assessments, obtaining pricing and reimbursement approvals, or submitting procurement tender applications. This will make it easier for generics to enter the market immediately following expiry of patent protection.
• Orphan market exclusivity: The period of market exclusivity available for an orphan medicinal product, which is currently ten years, will be nine years. However, orphan medicinal products addressing a disease with no current available medicinal treatment, known as "breakthrough orphan medicinal products", will benefit from up to eleven years of market exclusivity.
• Supply obligations: Member States will have the power to require companies to supply medicines benefiting from regulatory protection in sufficient quantities to meet patient needs and "otherwise, generics can enter the market".
• Shortage Prevention Plans: It has been confirmed that new measures requiring marketing authorisation holders to put in place and update shortage prevention plans will apply to all prescription only products. The measures may also apply to other products identified by the Commission.
• Antimicrobial resistance: The introduction of a "transferable data exclusivity voucher" for priority antimicrobials. The one use only voucher will give the right to 12 additional months of data protection for one authorised product, be that the priority antimicrobial or another centrally authorised medicinal product of the same or different marketing authorisation holder. Other measures on antimicrobial resistance include that all antibiotics will become prescription-only, subject to limited exemptions, and must include a warning on misuse inside the packaging.
• Procedural amendments: The EMA's Committee for Medicinal Products for Human Use ("CHMP") timeline to issue a scientific opinion in centralised marketing authorisation procedures will be shortened from 210 to 180 days. In addition, at the initial press conference, it was indicated that patient organisations and healthcare professionals will have voting rights in certain EMA processes.

Next steps

The provisional agreement on the reform of the EU pharmaceutical legislation starts to give companies some certainty on how to prepare for the new EU pharmaceutical framework.

A thorough review of the official text, once published, will be necessary to fully assess the full implications for industry, both positive and negative.

Only once both the European Parliament and the Council have adopted the text will the Directive and Regulation undergo legal-linguistic review and translation. The legislation will then be published in the EU Official Journal, triggering the implementation process. The legislation is expected to enter into force in mid-2026 and to apply around mid-2028, assuming a two-year transition period, although certain provisions may be subject to different transition dates as set out in the Directive and Regulation composing the reform of the EU pharmaceutical legislation.

Ahead of application, the Commission and EMA are expected to publish a series of implementing and delegated acts, as well as guidelines, to support the implementation of the new EU pharmaceutical framework.

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