On 16 January 2024, the European Commission’s Health Emergency Preparedness and Response Authority (HERA) called on a wide array of stakeholders, including Member States, local authorities, health professionals and pharmaceutical firms, to join the Critical Medicines Alliance (CMA) and combat shortages of key medicines (see, attached European Commission press release). The CMA is a consultative mechanism and network that will last for five years, start work in the Spring of this year, and come up with a first list of recommended action points in the Fall to improve the supply of critical medicines.

The CMA results from sustained efforts in various quarters to tackle medicine shortages. Not only have a series of initiatives at different levels of government sprung up over time, the pharmaceutical legislative package which the European Commission presented in April 2023 will, when adopted, also have a profound and wide-ranging impact (see, Van Bael & Bellis Life Sciences News and Insights of 3 May 2023). At about the same time, the Belgian government presented a three-point action plan that immediately garnered wide support among EU Member States (see, Van Bael & Bellis Life Sciences News and Insights of 4 May 2023).

Sensing the acute need to anticipate on the adoption and implementation of the pharmaceutical package, which is still a few years away, the European Commission presented in October 2023 a plan containing short- and medium-term measures to address medicine shortages in Europe ((see, Van Bael & Bellis Life Sciences News and Insights of 2 November 2023). This was followed by the publication of a Union list of critical medicines in December 2023 (see, Van Bael & Bellis Life Sciences News and Insights of 13 December 2023).

Not surprisingly, the security of medicine supply is a priority of the current Belgian presidency of the Council of the EU.

HERA says the CMA will pursue strategic autonomy for critical medicines by (i) creating international partnerships to diversify global supply chains; (ii) boosting Europe’s capacity to produce critical medicines and ingredients; (iii) developing a common approach to medicines stockpiling; and (iv) coordinating funding to combat medicine shortages.