Pharmaceutical Package Compromise following the Polish Presidency of the EU Council

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Pharmaceutical Package Compromise following the Polish Presidency of the EU Council

The adoption of a common position on the revision of the pharmaceutical package by EU Member States is rightly presented as a success of the Polish Presidency. What do the planned regulations currently entail?

On 4 June 2025, the Council of the European Union announced that it has adopted a position on the Pharma Package, the biggest reform of EU pharmaceutical law in over 20 years.

Agreeing on a common mandate was one of the priorities of the Polish Presidency of the Council of the EU. This consensus
is the result of intense negotiations over many months and brings the EU closer to ensuring better access to safe and affordable treatments, as well as strengthening innovation and resilience in the European pharmaceutical sector.

In this report, we examine selected significant changes compared to the original wording of the package (which we discussed in our report two years ago “Pharmaceutical Package: The biggest reform in EU pharmaceutical law in 20 years”). Now, as we did then, we focus on the three declared objectives of the new legislation: fostering innovation of medicines, increasing access to medicines, and environmental concerns.