European Commission Publishes Union List of Critical Medicines to Tackle Shortages
- 13/12/2023
- News
The European Commission (the Commission), the European Medicines Agency (EMA), and the heads of the Member State medicines agencies published yesterday the first Union list of critical medicines (see, attached press release) (the Union Critical Medicines List or UCML). The UCML contains more than 200 active substances used in medicines for human use whose critical character was determined on the basis of two criteria: (i) the medicine’s therapeutic indication which targets a serious condition; and (ii) the availability of appropriate alternatives for that medicine. It will be updated annually.
The UCML forms part of a series of short-term and medium-term measures which the Commission unveiled at the end of October 2023 to prepare the EU against medicine shortages (see, Van Bael & Bellis Life Sciences News and Insights of 2 November 2023). At the same time, the UCML does not in and of itself create obligations for marketing authorisation holders. These will only gradually see the light of day in accordance with the Commission’s plan of October 2023 and, later, as part of the Commission’s pharmaceutical package to reform the regulatory framework for medicines (see, Van Bael & Bellis Life Sciences News and Insights of 3 May 2023). Measures which the European Commission will consider shortly include monitoring requirements, incentives to diversify and attract manufacturing investments in Europe and procurement strategies to support security of supply. Separately, the Commission will continue to assess the vulnerability of the supply chain.
