Introduction
On 4 June, EU Member States, meeting in the Council of the European Union (‘Council’), have agreed on a position on the pharmaceutical reform package.
This agreement was reached despite significant divergences between EU Member States in the preceding weeks. It marks a key milestone in the process for adoption of the EU revision of EU’s general pharmaceutical legislation, as it sets out the Council’s position for the trilogue negotiations to find a text agreeable to the Parliament and the Council, which can now begin.
The innovative pharmaceutical industry will welcome aspects of the Council’s adopted negotiating mandate as it provides greater certainty with regards to regulatory data protection and it lightens some of the obligations introduced in the European Commission proposal for reform of the EU pharmaceutical legislation adopted in April 2023 and the European Parliament’s position adopted on 10 April 2024 (see our detailed advisory). At the same time, the Council has adopted positions on some aspects of the proposals that could be seen as less favourable to industry.
We discuss some of the key provisions and changes in the Council’s adopted position below. This is, however, not covering all elements of the reform of the EU pharmaceutical legislation and the final outcome of the legislative process remains uncertain.
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