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Image header Agence Europe
Europe Daily Bulletin No. 13596
SECTORAL POLICIES / Health

Main elements of EU proposal on critical medicinal products

According to reports, the European Commission’s proposal on critical medicinal products, expected on Tuesday 11 March, will include a section on ‘Enabling conditions for investment(see other news).

The proposal would stipulate that a project located in the EU involving the creation or increase of manufacturing capacity is considered a strategic project if it meets several criteria, such as creating manufacturing capacity for one or more critical medicinal products or modernising an existing manufacturing site.

Designated strategic projects could benefit from priority financial support from Member States if they address a vulnerability in critical medicines supply chains identified following an assessment. Strategic projects could also benefit from EU funding under the EU’s MFF (Multiannual Financial Framework).

Demand-side measures would be provided for: at the reasoned request of at least three Member States, the Commission could act as a facilitator for public procurement by the requesting Member States (Article 39 of the Directive on public procurement for medicinal products of common interest).

Joint procurement. By way of derogation from the financial rules applicable to the general budget of the Union, where nine or more Member States request the Commission to award a contract on their behalf or in their name, the Commission may launch a procurement procedure if the contract concerns critical medicinal products for which an assessment has identified a weakness in the supply chains.

A Critical Medicines Coordination Group would be set up, made up of representatives from the Member States and the Commission. (Original version in French by Lionel Changeur)

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