11/12/2025
Insights Blog

The long-awaited revision of the EU pharmaceutical legislation has reached a significant milestone: agreement has been secured at the trilogue stage between the European Commission (“the Commission”), the European Parliament (“the Parliament”) and the Council of the European Union (“the Council”). This marks the conclusion of interinstitutional negotiations on the comprehensive legislative proposals, which are the first major overhaul of EU medicines law in over 20 years. This will be seen as a defining moment in the Danish Presidency of the Council, which ends on 31 December. At a European Parliament press conference following conclusion of the negotiations, the efforts of the Polish Presidency during the first half of 2025 were also commended, in terms of the significant work which was undertaken in developing a common position for the negotiations.

We set out the background to leading up to and the commencement of the trilogue negotiations in our June piece: EU Pharma Package: Trilogue negotiations commence.

The Commission first proposed a revision of pharmaceutical laws in April 2023, intending to replace existing legislation with a new Directive and Regulation, generally referred to as the Pharma Package (the “Pharma Package”).The Commission initiated the reform aiming to modernise the regulatory framework to foster innovation, improve access to medicines, and strengthen supply chain resilience. Parliament adopted its position in April 2024, followed by Council in June 2025. Parallel trilogue discussions on the Directive and Regulation have now reconciled these positions into final compromise texts.

Key features of the package

While full details will be confirmed upon publication, the co-legislators have agreed on a framework which includes:

  • An eight-year regulatory protection period, with one year of market protection – with the possibility of extension for one more year.
  • Provisions for orphan medicines which meet unmet medical needs, which it appears will be referred to as “breakthrough” medicines.
  • Day one access for generic and biosimilar medicines, following expiry of intellectual property rights.
  • A transferrable exclusivity voucher linked to the development of priority antibiotics, which can extend market exclusivity for up to one year if certain conditions are met.
  • A reduction in the time for evaluations by the European Medicines Agency.
  • Digital measures, such as QR codes, to improve patient information across languages.
  • A six-month notification period for shortages.

Next steps

Although political agreement has been reached, several formal steps are likely to remain before the Pharma Package becomes law:

  • Legal-linguistic Review – the compromise texts will undergo technical and linguistic checks to ensure consistency across all EU languages.
  • Formal adoption – the European Parliament and the Council need to approve the agreed texts.
  • Publication in the Official Journal – once adopted, the legislation will be published in the Official Journal of the European Union. This publication triggers the start of the implementation timeline.
  • Entry into Force and Transition Periods – the new Directive and Regulation will enter into force on the date specified in the Official Journal, with transitional arrangements for industry compliance.

Companies should prepare fundamental changes to regulatory data protection, market exclusivity, and supply/shortage notification obligations. Strategic planning for product development and lifecycle management will be essential to navigate the new framework effectively.

For more information, please contact our Life Sciences Group.