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ARTICLE · 19 JANUARY 2026

EU Reaches Agreement On ‘Pharma Package’ Legislative Reforms

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On 11 December 2025, the Council of the European Union (the “Council”) and the European Parliament (the “Parliament”) provisionally reached an agreement on the first major reform of EU pharmaceutical rules since 2004. The agreement (known as the “Pharma Package”) aims to increase patients’ access to medicinal products across the EU and to boost the competitiveness of the pharmaceutical industry.

IrelandAntitrust/Competition Law
Kate McKenna
Kate McKenna
Seóna O'Donnellan
Seóna O'Donnellan
Simon Shinkwin
Simon Shinkwin
Emma Doherty
Emma Doherty
John Coary
John Coary
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On 11 December 2025, the Council of the European Union (the “Council”) and the European Parliament (the “Parliament”) provisionally reached an agreement on the first major reform of EU pharmaceutical rules since 2004.   The agreement (known as the “Pharma Package”) aims to increase patients’ access to medicinal products across the EU and to boost the competitiveness of the pharmaceutical industry.

The European Commission first published proposals for the Pharma Package in April 2023 (see previous publication here).  The Parliament adopted its position in April 2024, followed by the Council in June 2025, with the Parliament and Council now agreeing their joint position.  The text of the agreement has yet to be made public, but see below the key components of the agreement:

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