Pharma Package – Deal At The EU Level On A Major Pharma Reform

Yesterday, 11 December 2025, the Parliament and the Council of the EU, the two co-legislators in the EU, reached a provisional agreement on the so called "Pharma Package" during a trilogue between the European Commission, the Parliament and the Council of the EU¹. The Pharma Package gathers a new regulation², as well as new directive³ and is the biggest reform of EU pharma law since 20 years, amending among others Directive 2001/83/EC.

The European Commission presented a revision of the pharmaceutical framework on 26 April 2023⁴. Parliament adopted its position in April 2024⁵, and the Council of the EU one year later, under the Polish Presidency of the Council of the EU⁶.

This agreement is a success for the Danish Presidency of the Council of the EU, which listed the adoption of the Pharma Package as one of the goals of its presidency⁷.