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New data after marketing authorisation: European Commission consultation

 Advancing Healthcare Policy  Prescrire has contributed to a public consultation on the proposed revision of the rules governing variations to marketing authorisations, submitted to take into account new data, for example on efficacy or a new adverse effect.
Full article available for download (free)

In September 2023, Prescrire responded to a consultation organised by the European Commission prior to revising the "variation framework", which sets out the required procedures for updating marketing authorisations when new data become available, for example on adverse effects, efficacy or use in children (1).

The Commission's initial call for evidence stated that it wants to increase the efficiency of the current regulatory framework for post-authorisation changes. It is aiming to reduce the administrative burden for marketing authorisation holders and authorities, and to free up some of the resources currently needed to process the large number of post-authorisation changes. Its proposals include potentially increasing the proportion of variations subject to less stringent requirements, and thus less oversight (2).

In Prescrire's opinion, it would appear logical and inevitable for the workload associated with post-authorisation management of drugs to increase year on year, because new drugs are authorised every year, while existing drugs are rarely withdrawn from the market.

In order to ensure an acceptable level of patient protection, Prescrire called on the Commission to allocate sufficient resources (both human and financial) to the European Medicines Agency (EMA) to enable it to fulfil its obligations regarding the oversight of an ever-increasing number of authorised drugs.

In Prescrire's view, there is nothing inherently wrong with simplifying and rationalising administrative tasks, provided that this does not have a negative impact on the surveillance of drug efficacy and patient safety. Prescrire called on the Commission to set stricter standards for the clinical evaluation of drugs prior to authorisation (in order to reduce the number of drugs to be monitored that are not useful to patients), and to strengthen the requirements for post-authorisation evaluation.

Prescrire also urged the EMA to reduce its workload by reviewing the need to keep drugs on the market that have no real clinical utility or that are more dangerous than beneficial.

Finally, Prescrire also stressed the urgent need for more transparency about variations concerning efficacy and adverse effects, and to make more post-authorisation evaluation documents systematically available to the public (1).

1- Prescrire Editorial Staff "Prescrire's response on a call for evidence of the European Commission on the Revision of the variation framework for medicines" 20 September 2023: 2 pages.
2- European Commission "Call for evidence: Pharmaceuticals – changes to marketing authorizations (revision of the variation framework for medicines)" 29 August 2023: 4 pages.

 ©Prescrire 1 July2024

Source: "New data after marketing authorisation: European Commission consultation" Prescrire Int 2024; 33 (261): 194-195. Free.

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