On 11 December, the European Parliament and the Council of the European Union reached a political agreement on the reform of the EU pharmaceutical legislation, concluding trilogue negotiations with the European Commission. This “pharmaceutical package” updates the regulatory framework for medicinal products for human use and represents the most significant revision of EU medicines law in over two decades. The new framework aims to improve equitable access to medicines across Member States, strengthen security of supply, and streamline regulatory procedures. Revisions include updated provisions for regulatory data protection and market protection, enhanced company obligations to prevent shortages, and modernised regulatory pathways to reduce administrative burdens. Under the agreement, new medicines benefit from eight years of data protection and one year of market protection, with targeted extensions where conditions are met.
The legislation also includes updated mechanisms to prevent and manage medicine shortages, with strengthened requirements for early notification and supply continuity planning by marketing authorisation holders, as well as more systematic availability monitoring at EU level. The political agreement preserves and clarifies the formal role of patient representatives in the scientific assessment process at the European Medicines Agency (EMA), including participation in the Committee for Medicinal Products for Human Use (CHMP). During negotiations, a number of European patient organisations, including Alzheimer Europe alongside the European Patients’ Forum (EPF) and EURORDIS, contributed to calls to maintain meaningful patient involvement in regulatory committees. Patient representation in EMA’s scientific committees forms part of the broader framework for engaging stakeholders in regulatory decision-making.
Following the agreement, the legislative texts will undergo legal-linguistic finalisation and then be formally adopted by the Parliament and the Council. They will be published in the Official Journal of the European Union. The Regulation will enter into force 20 days after publication, and the Directive will require transposition by Member States over approximately 18 months. Full implementation of the reformed pharmaceutical framework is expected between 2026 and 2029, reflecting phased application of the new rules and Member State adaptation requirements. Read more in the European Parliament’s press release: