Strengthening EU’s medicine supply: The EU Commission’s Critical Medicines Act proposal

In recent years, shortages of medicines have become an increasingly urgent challenge within the EU. The pandemic, geopolitical tensions and a growing dependence on manufacturing outside the EU have exposed vulnerabilities in the supply chain for critical medicines. In response, on 11 March 2025, the European Commission presented a proposal for a new regulation—the Critical Medicines Act (CMA)—aimed at strengthening the EU’s resilience and ensuring access to essential medicines in the EU.

The scope of the proposed regulation is primarily centred on the medicines that are identified as critical on the EU’s List of Critical Medicines. The list, developed jointly by the European Medicines Agency (EMA), the European Commission and the Heads of Medicines Agencies (HMA), is formally established as part of the ongoing revision of EU pharmaceutical legislation, presented in April 2023. Critical medicines are those for which few or no alternatives are available, and where shortages pose a serious threat to patient health. They are medicines that must always be available in the EU to guarantee continuity of care, high-quality healthcare, and to protect public health across the EU. The category includes a wide range of medicines, from antibiotics and anticoagulants to cancer drugs and cardiovascular medicines.

The proposed regulation also aims to improve availability of other medicines of common interest, i.e., medicines other than critical medicines, which may not be affected by supply issues but are still not available to patients in three or more Member States, such as orphan drugs. However, not all rules in the act will be applicable to these medicines.

The Critical Medicines Act forms part of the EU’s broader pharmaceutical strategy and complements the ongoing reform of the EU’s pharmaceutical legislation.

The specific objectives of the initiative are as follows:

• To facilitate investment in manufacturing capacity for critical medicines and their active ingredients and other essential inputs within the EU.
• To reduce the risk of supply disruptions and strengthen availability by encouraging diversification of supply chains and resilience in public procurement procedures for critical medicines and other medicines of common interest.
• To leverage the aggregated demand of participating Member States through joint procurement procedures.
• To also support the diversification of supply chains to facilitate the establishment of strategic international partnerships.

The Swedish Government welcomes the Commission’s proposal for a regulation on critical medicines, and its ambitions. The proposal is now being considered by the European Parliament and the Council, where it may be subject to numerous amendments and lengthy voting processes. It is therefore not yet possible to predict whether, when, or in what specific form the proposed regulation will come into force.

The Critical Medicines Act is a step towards achieving a more robust and autonomous pharmaceutical supply within the EU. The proposal aims to enhance the supply of essential medicines in the EU by minimising the EU’s dependence on non-EU medicine suppliers, by incentivising supply chain diversification and boosting domestic manufacturing in the EU. Setterwalls is closely monitoring this matter and will provide updates as soon as there are any new developments.