On 11 March 2025, the European Commission published a proposal for a Critical Medicines Act (CMA).

The CMA introduces measures to improve the security of supply chains and availability of critical medicinal products and medicinal products of common interest in the European Union (EU). Some of the proposed measures directly affect Life Sciences companies, while other measures targeting the EU Member States can have a significant indirect impact on Life Sciences companies.

Scope of the CMA

    The CMA applies to:

    • Critical medicinal products: These are listed in the Union list of critical medicines as updated, and include the medicinal products whose insufficient supply is considered to pose (risk of) serious harm to patients, as discussed in our previous blog post.
    • Medicinal products of common interest: These are medicinal products, other than critical medicinal products, the supply of which does not sufficiently meet patient needs in three or more EU Member States, such as orphan medicinal products or novel antimicrobials.
    • Critical medicinal products with a supply chain vulnerability: Some measures of the CMA apply to critical medicinal products only in case of a supply chain vulnerability (defined as a risk or weakness in the supply chain that compromises the continuous supply to patients in the EU). The vulnerability is assessed at the aggregated level, considering all authorised medicinal products in the EU with the same route of administration and formulation.

    New Opportunities for Life Sciences Companies

    • Support for Strategic Projects: Authorities in the EU Member States can designate industrial projects in the EU as ‘Strategic Projects’ under certain conditions, such as increasing manufacturing capacity of a critical medicinal product or active substance (API), or supporting technology essential for manufacturing key inputs (i.e. material other than API required to manufacture a medicinal product). Benefits of the strategic project designation include:
      • Financial support from the EU and EU Member States: Strategic Projects that address a supply chain vulnerability are prioritised.
      • Priority in permit granting processes: This includes prioritisation in the processes of the relevant permits to build and operate a strategic project.
      • Regulatory support by EU Member States: This includes prioritisation in Good Manufacturing Practices inspections for new or modernised manufacturing sites.
      • Dedicated scientific advice from the European Medicines Agency (EMA).
    • Stock obligation clarity for EU Member States: The ability of EU Member States to impose security stock obligations on marketing authorisation holders (MAH) and other entities is somewhat framed and restricted under the CMA. Such obligations must:
      • Not result in any negative impact in another EU Member State (e.g., lead to or worsen a shortage).
      • Be proportionate and respect the principles of transparency and solidarity.
    • Extending the scope of European Commission-led procurement and joint procurement between the European Commission and EU Member States: Both procurement pathways are possible for critical medicinal products with an identified supply chain vulnerability and for medicinal products of common interest that have undergone a joint clinical assessment (JCA) under the HTA Regulation (see our blog).
    • Protecting Commercially Confidential Information (CCI) shared: Economic operators can submit confidentiality claims for information shared with the European Commission or EU Member States authorities under the CMA. The CMA requires the authorities to assess such claims and protect CCI from unjustified disclosure.

    New Obligations and Risks for Life Sciences Companies

    The CMA does not introduce new shortages reporting obligations or stockpiling obligations for MAHs at EU level.

    • New supply chain resilience criteria for procurement: EU Member States must include criteria on supply chain resilience in national procurement processes. The criteria can relate to stockholding obligations, the number of diversified suppliers, or monitoring of supply chains. This could impact Life Sciences companies looking to participate in procurement processes.
    • Preference for EU-based manufacturing in procurement: When critical medicinal products with a supply chain vulnerability or medicinal products of common interest have a high dependency on non-EU countries, EU Member States must favour in procurement processes suppliers who manufacture a significant portion of the medicinal products in the EU.
    • Supply commitments for strategic projects: Companies receiving financial support for a strategic project:
      • Can be required by the EU Member State to provide the necessary supplies of a critical medicinal product, API or key inputs to the EU market to prevent shortages.
      • Must prioritize supply of the critical medicinal product to the EU market and make best efforts to ensure its availability in the EU Member States where it is marketed for as long as it is listed in the Union list of critical medicines.
    • Uncertainty on medicinal products of common interest: While critical medicinal products are listed in the Union list of critical medicines, no similar list exists for medicinal products of common interest, leading to uncertainty about which products are considered as such.
    • Information sharing obligation: Economic operators in the supply and distribution chains of critical medicinal products, API and key inputs, or of medicinal products of common interest, must provide information necessary for the application of the CMA if requested by the European Commission or EU Member State authorities. It is unclear what this information sharing obligation will entail in practice.

    Next Steps

    The proposal will now be discussed by the Council of the European Union and the European Parliament, with potential amendments and final adoption of the CMA which is expected by the end of 2025.