The European Commission tackles shortages of critical medicines through the Critical Medicines Act

On Tuesday 11 March 2025, the European Commission published a legislative proposal for a Critical Medicines Act (“CMA”). The objective of this Act is to ensure stable supply and continuous availability of medicinal products designated as “critical” and included in the Union List of Critical Medicinal Products. The CMA was included as a matter of priority in President Von Der Leyen’s political guidelines as a key legislative measure to reduce dependencies and enhance the EU's resilience, particularly in the supply of medicines, active pharmaceutical ingredients (“APIs”) and other essential inputs used in pharmaceutical manufacturing, where the supply is concentrated among a small number of manufacturers or countries.

The CMA applies to critical medicines under the Union List of Critical Medicinal Products while its public procurement measures also apply to medicines of common interest. Although medicines of common interest are defined in Article 3(5) of the CMA, there is currently no specific list of such medicinal products, nor does the CMA or other EU legislation outline a method for designating them as such.

An overview of the CMA

The main elements of the proposed Act include:

Facilitating EU-based strategic projects

The CMA requires EU Member States to support companies (“project promoters”) that engage in projects that have been designated as “strategic” by national competent authorities based on the criteria outlined in Article 5 of the CMA. In a nutshell, EU projects would be considered “strategic” for the purposes of the CMA if they are EU-based and they create, increase or improve the manufacturing capacity of a critical medicine, an API or key inputs necessary for the manufacturing of critical medicines or APIs (e.g., excipients).

The support provided would take the following forms:

• Accelerated procedures in permit granting processes (e.g., building/construction permits, chemical permits, grid connection, environmental assessments, etc.);
• Administrative support to enable project promoters to effectively implement the strategic project;
• Regulatory and scientific support from national medicines agencies and the European Medicines Agency (“EMA”);
• Coordination of various environmental assessments and authorizations deriving from several EU environmental legal instruments;
• Issuance of the environmental impact assessment of the effects of public-private projects within an accelerated timeframe of 45 days from the receipt of all relevant information.

Financial incentives for strategic projects and related obligations for companies

The CMA foresees the possibility of national governments to prioritise financing of strategic projects that address a vulnerability in the supply chain of critical medicines. Companies receiving such financial benefits would be required to prioritise supply to the EU market and try, to the best of their abilities, to ensure availability of the products in question on the EU market to avoid shortages. This obligation would be in effect for as long as the critical medicine is on the Union List of Critical Medicines. 

EU funding would also become available through various EU funding instruments – to the extent their scope allows for it – for the duration of the Multiannual Financial Framework 2021-2027. 

Procurement criteria to extend beyond price considerations

National procurement processes must account for supply chain security and availability, in addition to price considerations. Relevant factors may include stockholding requirements, number of diversified suppliers, supply chain monitoring requirements, contract performance clauses, etc.

In relation to critical medicines for which a supply chain vulnerability has been established as well as medicines of common interest, national authorities in charge of public procurement decisions would be required to favour suppliers that manufacture a significant proportion of the critical medicines in the EU, taking into account market and public health considerations. 

Collaborative, joint or European Commission-driven procurement on behalf of EU Member States

• Collaborative procurement: Building on existing collaborative procurement tools such as the Regulation (EU) 2022/2371 on serious cross-border threats to health,  the proposed CMA foresees that the European Commission can facilitate cross-border procurement of critical medicines in case at least three EU Member States submit a related request. This would include facilitating communication and cooperation between interested EU Member States and advising on EU public procurement rules and pharma regulatory issues.
• Joint procurement: This type of procurement can be triggered at the request of at least nine EU Member States or at the European Commission’s initiative for:
  • critical medicines for which a supply chain vulnerability has been identified or for which the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (also known as the Medicine Shortages Steering Group or “MSSG”) has recommended a common procurement procedure; or
  • medicines of common interest for which a joint clinical assessment (JCA) report has been published² or that have undergone a clinical assessment under the HTA Regulation’s voluntary cooperation mechanism.³
• Procurement by the European Commission on behalf of EU Member States: For the above-listed categories of medicines, the proposal also foresees the possibility of the European Commission to procure those medicinal products on behalf of EU Member States, at the request of at least nine EU Member States.

Critical Medicines Coordination Group

The proposed CMA establishes the Critical Medicines Coordination Group which would be comprised of two permanent representatives from each EU Member State and the EMA would participate as an observer. Its main tasks would include facilitating discussion on the strategic orientation of financial support of strategic projects, cooperation and exchange of information between national procurement authorities, advice on the order of priority for the vulnerability evaluation of critical medicines etc.

Reaction of Industry Associations

Medicines for Europe, the industry association representing the generic and biosimilar industries, characterised the proposal as a “major milestone for increased strategic autonomy in Europe”, but called for real procurement reform and the deployment of stronger financing mechanisms that would necessitate a new approach to EU state aid and rules on Important Projects of Common European Interest (IPCEI), a dedicated EU critical medicines manufacturing fund and national stockpiling obligations. EFPIA, on the other hand, called for clarity regarding the specific circumstances under which collaborative procurement would accelerate patient access to critical medicines. According to EFPIA, a blanket application of collaborative procurement “could create more harm than offering a more permanent solution to access related issues”.

Next steps

The proposed CMA is undergoing review by the European Parliament and the Council of the European Union under the ordinary legislative procedure. Both institutions may introduce amendments to the proposed text, which will then be negotiated in inter-institutional discussions, also involving the European Commission. In the European Parliament, two committees—the Public Health Committee (SANT) and the Industry, Research and Energy Committee (ITRE)—are currently vying to be the lead committee on this file, though no decision has been made yet.

If you have any questions about the CMA or other regulatory matters, please feel free to contact us. Our team is ready to provide insights on the latest legislative developments and support you in navigating compliance requirements.

Authored by Fabien Roy and Anastasia Vernikou.