The EU pharma package: how close is it to becoming law?

The long-awaited EU pharma package will consolidate and substantially replace the existing body of EU medicine-related legislation – including the rules on marketing authorisations, centralised procedures, orphan medicines and paediatric medicines. This will be achieved by a new Directive and a new Regulation, marking the first comprehensive revision in over twenty years. The reform, proposed by the European Commission in April 2023, seeks to promote innovation, strengthen the availability and affordability of medicinal products, reduce regulatory burdens and modernise the framework governing how medicines are authorised and supervised across the single market. Companies operating in the life sciences sectors will need to closely monitor these developments, as the new framework will have significant implications for regulatory strategy, product lifecycle management and market access procedures and requirements across the EU.

On 11 December 2025, the European Parliament, the Council of the European Union and the European Commission reached political agreement at the trilogue stage, concluding interinstitutional negotiations. Since then, the procedural steps have advanced at a steady pace. The Council’s Committee of Permanent Representatives formally endorsed the texts agreed on (by compromise) on 6 March 2026. The European Parliament’s Committee on Public Health subsequently voted to approve the texts on 18 March 2026.

The legislative texts are currently undergoing legal-linguistic review, the procedural step in which all language versions are finalised before publication in the Official Journal. Estimates for formal adoption by both the Council and the European Parliament have ranged from summer to late autumn 2026. The Parliament and Council have concluded an early second reading agreement, meaning the Council will first formally adopt its position, after which the Parliament is expected to endorse it in a second reading.

Once formally adopted and published in the Official Journal, the new Directive and Regulation will enter into force 20 days later, triggering agreed transitional periods. Full applicability is expected by 2028. For pharmaceutical and life sciences companies, the transition period will be critical in terms of assessing the impact of the new rules on existing operations and pipeline projects — including regulatory data protection periods, incentive structures for orphan and paediatric medicines, and the conditions for marketing authorisations. Setterwalls continues to monitor these developments closely and will report further as the legislative process nears or reaches its conclusion.