Critical Medicines Act: Legislative Process Enters Next Phase

The COVID-19 pandemic exposed the structural vulnerability of European pharmaceutical supply chains. With the Critical Medicines Act (“CMA“), the European Union seeks to respond to this challenge and to strengthen the long-term availability, supply security and production of critical medicines in Europe. The European Commission presented a corresponding draft regulation in March 2025. Following the Council's adoption of its position on the legislative proposal in December 2025, the European Parliament also adopted its position on the CMA on 20 January 2026 by a clear majority. This paves the way for the commencement of trilogue negotiations.

Objectives and Key Instruments of the CMA

The CMA aims to reduce dependency on third countries, diversify supply chains and strengthen the competitiveness of the European pharmaceutical industry. 

“Critical medicines” are defined as those medicinal products for human use that are included in the “Union List of Critical Medicines” maintained by the European Commission, the European Medicines Agency and the Heads of Medicines Agencies. The CMA expressly refers to this Union List and the designation procedure provided for in the EU Pharmaceutical Package. The list comprises active substances that are considered essential for the healthcare systems of the EU. It covers a broad spectrum, including antibiotics, insulin, medicinal products for the treatment of chronic diseases and other core indications for primary and acute care. Vaccines and medicinal products for rare diseases are also included. The decisive criteria for inclusion are the use in the treatment of serious diseases and the lack of available therapeutic alternatives. The CMA focuses not only on “critical medicines” but also on so-called “medicines of common interest”, which are required but not or only limitedly available in three or more Member States. 

The key instruments of the CMA include in particular:

• Strategic Projects: Strategic projects shall be designated for the manufacture of critical medicines and their precursors. These projects benefit from accelerated authorisation procedures and facilitated access to national and European funding.
• Amendments to Procurement Law: New procurement rules are intended to enable contracting authorities to give greater consideration to supply security and supply chain resilience. The Commission shall also support coordinated, cross-border procurement procedures.
• International Partnerships: In addition, the draft proposal provides for the establishment of partnerships with “like-minded” third countries in order to broaden the supplier base and thereby reduce dependency on individual suppliers. 
• Guidelines: Specific State aid guidelines are intended to provide Member States with legal certainty when supporting strategic projects. 

Position of the European Parliament

In its opinion, the European Parliament sets additional priorities that are of considerable practical significance, particularly for pharmaceutical companies. It proposes an expansion of the definition of “medicines of common interest” to expressly include orphan drugs. Furthermore, the Parliament advocates for the prioritisation of funding for strategic projects in the current and upcoming EU multiannual financial framework. In return, companies receiving public funding shall be obliged to prioritise supply to the EU market.

In the area of public procurement, the Parliament calls for a clear departure from pure price competition. In the future, qualitative criteria such as supply security, supply chain diversification and production locations shall be given greater consideration. Specifically, preference shall be given to manufacturers that produce a substantial part of critical medicines within the EU.

Furthermore, the minimum number of Member States for joint procurement procedures shall be reduced from the current nine to at least five in order to make such procedures more practicable. To prevent and manage shortages, the Parliament also calls for an EU-wide coordination mechanism for emergency reserves. As a measure of last resort, the Commission shall even be empowered to order a redistribution of medicines between national stockpiles in the event of acute shortages.

Next Steps in the Legislative Procedure

With the adopted positions of the Council and Parliament, the CMA has entered the decisive phase of the legislative procedure. The final version of the legislation will now be negotiated in trilogue. The substantive focus of the discussions is expected to be on the design of the strategic projects as well as the scope of the new provisions relating to procurement law and State aid law. Considering the scepticism already expressed by healthcare payers, the departure from pure price competition is likely to lead to debate. The scope of supply obligations for funded companies as well as the Commission’s crisis powers are also likely to be subject to controversial negotiations. 
Assessment and Outlook

The CMA marks a paradigm shift in EU health policy: away from pure cost competition towards greater supply security and industrial resilience. For the life sciences sector, this creates new opportunities, for example through funding possibilities and improved framework conditions for production investments in the EU. At the same time, regulatory requirements are also increasing, particularly in procurement law and State aid law as well as regarding supply obligations towards the EU market. Companies should therefore engage with the potential implications of the CMA for their production, procurement and funding strategies at an early stage.