EU Council and Parliament reach an agreement on the pharma package

The Council of the European Union and the European Parliament have agreed on a proposal for new EU pharmaceutical legislation (called the ‘pharma package’). Next, the legislative proposal will move to be formally approved by both the Council of the European Union and the European Parliament. 

The legislative reform is the most extensive change in the regulation of the pharmaceutical sector for two decades. The reform is expected to make notable progress in boosting the competitiveness of the pharmaceutical sector, facilitating new innovation, and ensuring access to medicines across the EU. 

The reformed EU pharmaceutical legislation will enter into force when it is published in the Official Journal after the formal adoption process. It will be applied after a transitional period.

Council of the European Union press release of 11 December 2025:
‘Pharma package’: Council and Parliament reach a deal on new rules for a fairer and more competitive EU pharmaceutical sector