Insights & news

European Commission and Belgian Presidency of Council of EU Launch Critical Medicines Alliance

  • 25/04/2024
  • News

On 24 April 2024, the Health Emergency Preparedness and Response Authority (HERA) of the European Commission (Commission) and the Belgian Presidency of the Council of the EU formally launched the Critical Medicines Alliance (CMA) as an industrial policy tool to tackle shortages of critical medicines. Following the presentation of its concept just six months ago (see, Van Bael & Bellis Life Sciences News and Insights of 2 November 2023) and a call for expression of interest in January 2024 (see, Van Bael & Bellis Life Sciences News and Insights of 18 January 2024), the CMA now counts some 250 registered members representing governmental authorities, business interests, industry associations, and non-governmental organisations (see, attached press release and questions and answers document).
 
The CMA is a consultative mechanism that will study ways to address weaknesses in the supply of critical medicines. It will not create new shortages rules or address specific problems associated with the availability of particular medicines. It will rather focus on relevant policy issues in relation to the (i) strengthening of EU manufacturing capacities; and (ii) the diversifying of international supply chains.
 
Inevitably, the question arises whether the formal start of the CMA will pave the way for a possible Critical Medicines Act or will rather be the first nail in the coffin of that instrument. The Critical Medicines Act has been in the making since May 2023 and secured the backing of a wide range of Member States (see, Van Bael & Bellis Life Sciences News and Insights of 4 May 2023). However, it raises delicate issues of financing and will compete with similar national plans in Member States such as France and Germany bent on funding their own facilities for the production of essential medicines and pharmaceutical ingredients.

Meanwhile, on the regulatory front, the many bodies with responsibility for addressing medicine shortages are not remaining idle pending the adoption by the European Parliament and the Council of the Commission’s pharmaceutical regulatory package (see, Van Bael & Bellis Life Sciences News and Insights of 3 May 2023). The Executive Steering Group on Shortages and Safety of Medicinal Products of the European Medicines Agency (EMA) has just offered an outline of the types of recommendations it could make to help tackle critical shortages. The EMA itself plans to publish guidance for shortage prevention plans in June 2024.

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