Final phase in the revision process of the new EU pharma legislation - what are your thoughts?

Therapy development
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On June 4th the European Council has reached an agreement on the revision of pharmaceutical legislation. This begins the final phase of negotiations with the European Parliament on the "pharmaceuticals package.

You can find more information about the process so far and the mandate for negotiations in the press release of the Council of Europe.

In the mandate of negotiations regulation and directive you can review the changes the Council proposes.

We would are interested to hear you thoughts about the proposed changes!

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By any chance, does anyone have an overview of where the positions of the Council, Commission and Parliament differ a lot? And/or where they align with the Council’s proposed amendments?

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I don’t have an overview of the different positions.
Regarding the process: since beginnen of 2024 there are meetings between the EU member states in so called ‘raadswerkgroepen’ on the Pharma legislation proposals of the EC. The Parliament has proposed changes as an opinion. Discussion in the raadswerkgroepen of the member states is still ongoing and it is expected to take quite some months untill there is agreement on the total package of proposed legislation changes. New legislation is not expected any sooner than 2026.
For the Netherlands, VWS participates in the Raadswerkgroepen, VWS receives input form a.o. IGJ and CBG.

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