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European Commission public consultation on the revision of European pharmaceutical legislation: Prescrire's response

 Advancing Healthcare Policy   The European Commission has launched a major revision of European pharmaceutical legislation. In November 2023, it opened its proposals to public consultation, to which Prescrire has responded. While Prescrire welcomes several of the proposals, some of them need to be further developed. Others are counterproductive or even dangerous, and should be rejected.
Full article (4 pages) available for download (free)

It is unfortunate that, in its proposals, the Commission did not see fit to act on the persistent, substantiated calls from a range of different stakeholders in recent years to strengthen regulatory standards by requiring marketing authorisations for new drugs to be based more firmly on robust evidence and on randomised comparative trials versus standard treatment.

The regulatory framework must raise the bar for the requirements and fundamental principles of standard marketing authorisations, while allowing flexibility under exceptional circumstances (as occurred with covid­-19 vaccines) by permitting limited exceptions to these fundamental principles. After a disappointing vote in the European Parliament, it is now up to the European Council to improve the proposals in order to facilitate access to useful, effective and affordable medicines.

©Prescrire 1 May 2024

Source: "European Commission public consultation on the revision of European pharmaceutical legislation: Prescrire's response" Prescrire Int 2024; 33 (259): 135-138. Free.

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See also:

"Revision of European
pharmaceuticals legislation"
Prescrire Int 2022;
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"Impending changes
to European pharmaceutical
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of the Commission's proposals:
major changes ahead,
improvements needed"
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31 (243): 302-304.
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"Impending changes
to European pharmaceutical
regulations. Part II.
The European Parliamentary
Research Service in favour
of a European Medicines
Infrastructure"
Prescrire Int 2023;
32 (244): 23-25.
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"Revision of European
pharmaceutical legislation"
Prescrire Int 2024;