english.prescrire.org > Topics > Advancing healthcare policy > Advancing healthcare policy in Europe: a chronological recap of actions > 2024 Recap > European Commission public consultation on the revision of European pharmaceutical legislation: Prescrire's response (May 2024)

Advancing healthcare policy

Advancing healthcare policy in Europe: a chronological recap of actions

A recap of actions in 2024
European Commission public consultation on the revision of European pharmaceutical legislation: Prescrire's response (May 2024)

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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