European pharmaceutical reform

On March 6, 2026, the Council of the European Union (“the Council”) published the provisional text of the political agreement regarding the European pharmaceutical reform, which includes a new Directive and a new Regulation.

The political agreement reached by the European institutions on December 11, 2025 is a decisive step towards modernization of the regulatory framework for medicines in the European Union. The European Parliament and the Council are expected to formally adopt this reform in the coming months.

Below we analyze the most relevant aspects of the provisional text and their implications for the sector.

1.    Regulatory data protection:

• The new framework establishes a protection period of 8+1(+1)(+1): eight years of regulatory data protection and one year of market protection, which can be extended for up to two more years if one of the following conditions is met:
• Market protection will be extended by one year if: (i) the product addresses an uncovered medical need; (ii) it is a medicinal product containing a new active substance for which comparative clinical trials have been carried out, and the first marketing authorization application has been submitted in the EU or has been submitted no later than 90 days after submission of the first application outside the EU; or (iii) those clinical trials evaluating efficacy have been carried out in more than one Member State. 
• Market protection will be extended by one year if, during the first eight years, the marketing authorization holder obtains authorization for one or more new therapeutic indications considered to bring a significant clinical benefit in comparison with existing therapies. This extension can only be granted once.
• The total protection period will be subject to a maximum of 11 years.

2.    Transferable exclusivity vouchers:

• To address the global challenge of antimicrobial resistance, the new Regulation creates the transferable exclusivity voucher or “TEV” for priority antimicrobials.
• The TEV, which can only be used once and is valid for five years, grants the right to 12 additional months of data protection for an authorized product, whether that is the priority antimicrobial or another medicinal product authorized in a centralized procedure, and it can only be transferred once to another holder.
• Granting of a TEV by the European Commission will be subject to strict conditions, including the authorization holder proving capacity to supply the priority antimicrobial in sufficient quantities in the EU, the obligation to disclose any direct financial support received for its development, and the submission of an authorization application to the European Medicines Agency (“EMA”) or no later than 180 days after submission of the first application outside of the EU.
• Noncompliance with the obligation to supply the priority antimicrobial in sufficient quantities in all Member States will lead to the TEV being revoked.

3.    Orphan medicinal products:

• The current 10-year exclusivity period on the market has been reduced to nine years as a general rule. However, breakthrough orphan medicinal products—those used for diseases for which there is no available treatment, and which result in a clinically relevant reduction in disease morbidity or mortality—can benefit from up to 11 years of exclusivity.

4.    Bolar exemption extended:

• The reform extends the scope of the Bolar exemption, meaning that certain preparatory activities for product launch and marketing will not constitute patent infringement. Such activities include health technology assessments, pricing approval reimbursements, and the submission of offers in procurement tenders.

5.    Access and supply obligations:

• The Member States will have new tools for guaranteeing patient access to the medicinal products. In particular, they will be able to require companies to supply in sufficient quantities those medicinal products that benefit from regulatory protection.

• Within one year from the granting of the marketing authorization, Member States will be able to impose obligations on the holders, such as submission of a valid pricing and reimbursement application, participation in procurement tenders and the establishing of a production distribution plan.

• If the holder does not comply in the three years from the request, the market protection period will cease to apply in the Member State in question. Applications for generic and biosimilar medicinal products can be submitted six years after the start of the regulatory data protection period, although the authorizations will only be granted when the regulatory protection period has ended.

6.    Shortage prevention plans:

• Marketing authorization holders should draft and regularly update their shortage prevention plans for all medicinal products subject to prescription. These measures can be extended to other products that the Commission identifies.

7.    Procedural and structural changes at EMA:

• The period for the EMA’s Committee for Medicinal Products for Human Use to issue its scientific opinion in centralized authorization procedures is reduced from 210 to 180 days.

8.    Environmental impact:

• Obligation to prepare an environmental risk assessment to be submitted with the marketing authorization application. Therefore, pharmaceutical laboratories must consider the scientific guidelines on the environmental risk assessment of medicinal products for human use and, failing that, they must provide justified reasons for any deviation from those guidelines.
• Pharmaceutical laboratories will include risk mitigation measures in the environmental risk assessment with the aim of avoiding or, when possible, limiting the emissions generated by that medicinal product.
• The marketing authorization can be suspended, revoked or subject to variations if there is detection of a serious environmental or public-health risk associated with a medicinal product that the authorization holder has not properly addressed.

Next steps and implementation schedule

The text of the Directive and of the Regulation will be subject to review, with an estimated end date between end of May and start of June 2026, after which the reform will be formally adopted and published in the Official Journal of the European Union. After that, a two-year transition period will start, and we expect the legislation to apply at the end of 2028 or start of 2029.