European Council advances proposed pharmaceutical reforms

The European Union’s overhaul of its regulatory regime for the pharmaceutical sector is a major undertaking—one that has already spanned nearly a decade. In April 2023, seven years after it started the process, the European Commission released its draft proposal for a new pharmaceutical legislative framework.

In June 2025, the European Council agreed its position on the proposed pharmaceutical reform framework, which now advances to the next step of trilogue negotiations. The Council remains aligned with the Commission’s original goal for the revised framework, which is to ease access to and increase affordability of medicines for patients in all Member States. The new regulations also seek to boost the competitiveness of the EU’s pharmaceutical industry, promote higher environmental standards, and reduce administrative burden for companies.

Background on the proposed legislation

The Commission’s original proposals include legislation that would replace Directive 2001/83/EC and Regulation 726/2004. Many of the key changes address the regulatory data protection (RDP) period and market protection period for new or innovative products. The RDP period offers pharmaceutical companies exclusive rights to data from pre-clinical tests and clinical trials, while the market protection period prevents other companies from putting similar products on the market.

The Commission proposed to cut the RDP period for new branded medicines from eight years to six years, which would make generic and biosimilar medicines available to patients earlier and allow for more affordable medicines. The proposal also looked to incentivise companies to make new medicines available to patients in all EU countries and to develop products that address unmet medical needs by providing an additional two years of market exclusivity protection after the RDP period.

Key changes from the Council

In its mandate, the Council rejected the Commission’s proposed changes to the RDP period for new branded medicines and elected to retain the baseline of eight years. This differs from the European Parliament’s position, which planned for a 7.5-year baseline RDP period. 

The Council also proposed cutting the current regulatory market protection for innovative products from a two-year baseline to one year. Certain products would be eligible for an additional year of protection if they met specific criteria, such as fulfilling an unmet medical need at the time of authorisation. 

The Council also introduced a new article, 56a, that outlines an obligation to supply. Under 56a, Member States have the power to oblige the marketing authorisation holder (MAH) of a medicinal product to “make that product available in sufficient quantities to cover the needs of patients in the Member State.” Legal experts with Baker McKenzie note that this requirement does not have defined criteria, granting Member States broad implementation discretion and raising concerns about inconsistent application across the EU.

The Council retained much of the Commission’s proposal related to monitoring and responding to shortages. The proposal includes requirements for national authorities and the European Medicines Agency (EMA) to monitor shortages of medicines. Pharmaceutical companies would also face additional obligations such as earlier reporting of shortages and would be required to develop and maintain shortage prevention plans. 

Next steps

The proposed pharmaceutical legislation will now face negotiation among the Commission, Council, and Parliament, who differ in some of their stances on key provisions. It is anticipated that a political agreement on the proposal will be reached before the end of 2025, and the revised Regulation and Directive will enter into force in early 2026. The final regulations are unlikely to take effect until 2029 at the earliest.

Stakeholders in the pharmaceutical supply chain should closely follow the trilogue discussions and the interinstitutional technical meetings throughout the remainder of the year to keep apprised of any significant changes that result from negotiations. While the regulations won’t be applicable for at least four years, they may require significant changes that companies should undertake sooner rather than later.

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