European Commission Proposes Critical Medicines Act to Bolster Security of Supply of Critical Medicines
- 18/03/2025
- News
On 11 March 2025, the European Commission (the Commission) tabled a draft Regulation “laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795” (see, attachment and related Q&A). The proposed Regulation, widely known by its moniker “Critical Medicines Act” (CMA), seeks to strengthen the security of supply and availability of the critical medicinal products featuring on the Union list of critical medicines, for which a shortage of supply would result in serious harm to patients because of a lack of alternatives. However, the CMA also targets other medicines of common interest whose supply is subject to market failures.
The CMA will achieve that objective by:
- facilitating investments in European manufacturing capacity for critical medicines, their active substances, and other key inputs;
- adapting existing public procurement procedures to incentivise supply chain diversification and resilience and not focus exclusively on price;
- increasing the reliance on collaborative procurement procedures among Member States; and
- intensifying international cooperation by concluding strategic partnerships.
The CMA was also expected to come up with strict limitations on the ability of Member States to create contingency stocks requirements but the general obligations on Member States not to harm other Member States and to respect the principles of proportionality, transparency and solidarity contained in Article 20 of the draft CMA would seem to fall short of the EU-wide “comprehensive, harmonised, and balanced framework” that was called for by the Critical Medicines Alliance (see, Van Bael & Bellis Life Sciences News and Insights of 3 March 2025).
The CMA will complement an already dense and still expanding regulatory framework governing supply chains and medicine shortages. The CMA will not only create new rules for Member States (to be sure, some of these are highly needed), but will also give rise to new reporting obligations for business (Article 29, draft CMA), and will establish yet another governmental body, the Critical Medicines Coordination Group, which will be required to “work closely” with the European Medicines Agency (EMA), the EMA’s “Executive Steering Group on Shortages and Safety of Medicinal Products”, known as MSSG, national regulatory authorities, and the Commission (see, Article 25, draft CMA). Given this ever more complex regulatory universe, delivering an oiled engine that makes critical medicines available for the EU patient will prove no mean feat.
