May 23. 2024. 8:13

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Pharma Package adopted at first reading with landslide vote, but what next?


After the European Parliament adopted the Pharma Package by a landslide vote at first reading on Wednesday (10 April), it is now at the mercy of the Council and the next Commission – assuming there is a new one in the next six months – and a new Parliament. So what next?

Putting aside all the unknowns, the fact that the directive and regulation were adopted with overwhelming votes of +495 and +488 respectively, suggests that there is solid cross-party support that will not be dismantled whatever the outcome of June’s EU elections.

“We hope the Council takes note of our ambition and commitment to create a robust legislative framework, setting the scene for prompt negotiations,” said the rapporteur for the directive, Danish MEP Pernille Weiss (EPP, DK).

Tiemo Wölken MEP (S&D, DE). Photo: Emilie Gomez © European Union 2024

The other rapporteur for the regulation, German Tiemo Wölken (S&D ), said the revision “paves the way for addressing critical challenges such as medicines shortages and antimicrobial resistance. We are strengthening our healthcare and resilience ahead of future health crises – a significant milestone in our pursuit of fairer, more accessible healthcare for all Europeans”.

An EU diplomatic source told Euractiv that the Belgian EU Council Presidency has organised a number of meetings focused on two issues: shortages and incentives (market exclusivity, regulatory data protection). The European Council’s ‘Working Party on Pharmaceuticals and Medical Devices’ is relatively early in their deliberations.

It is a large legislative package and member states will not be rushing through the details. Ministers will have important concerns that are very close to their hearts: access and safety of medicines, affordable healthcare systems, and the continuing competitiveness of the pharmaceutical industry – a sector where Europe is still a leading light.

Given the package’s complexity and the fact that this is the first revision in more than twenty years, there is good reason to proceed with caution.

The Hungarian Presidency, which takes over in July, will want to make progress on reaching a consolidated Council position, but more realistically, the package is likely to be under discussion into 2025.

Read more with Euractiv

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