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Critical Medicines Act

In “A new era for European Defence and Security”

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In its 2025 work programme, the Commission announced a 'Critical Medicines Act' to address the shortages of medicines and reduce dependencies relating to critical medicines and ingredients as well as to ensure the supply of affordable medicines.

In May 2023, 23 EU Member States proposed to launch a 'Critical Medicines Act' to diversify the pharmaceutical supply chains. This call was reiterated by the European Council in June 2023 and reinforced in October 2023. The Commission adopted in October 2023 a communication presenting actions to better prevent critical medicine shortages in the EU, published in December 2023 a first version of a 'Union list of critical medicines' and established in 2024 a 'Critical Medicines Alliance'. The European Economic and Social Committee issued in 2023 an exploratory opinion, followed by an opinion in June 2025. In its June 2024 opinion, the European Committee of the Regions supported the creation of a comprehensive critical medicines act. 

The proposal of a 'Critical Medicines Act' was announced by the President of the Commission in her July 2024 political guidelines. In November 2024, during his confirmation hearing, Olivér Várhelyi committed to tackle the endemic risks of shortages of critical medicines through a 'Critical Medicines Act', to be proposed by the Commission within the first 100 days of its mandate. This was confirmed in the Commission 2025 Work Programme. A call for evidence was launched in January 2025.

The Commission put forward the proposal for a regulation on 11 March 2025. It contributes to achieving the European Health Union, complements the ongoing revision of the EU pharmaceutical legislation (see separate fiche) and is also one of the actions set out in the 'Competitiveness Compass'.  

The proposed regulation aims to strengthen the security of supply and the availability of critical medicines within the EU, ensuring a high level of public health protection and bolstering the Union's overall security. In addition it aims to improve the availability and access to specific medicines  ('medicinal product of common interest') for which in three or more Member States the functioning of the market does not sufficiently ensure the availability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients (e.g. for rare diseases). The proposed regulation has four specific objectives: 1/ facilitate investment in manufacturing capacities for critical medicines, their active substances and other essential inputs within the EU; 2/ reduce the risk of supply disruptions and enhance availability by promoting supply chain diversification and resilience in public procurement procedures for critical medicines and other essential medicinal products; 3/ use the collective demand of participating EU Member States through collaborative procurement procedures; 4/ support supply chain diversification by facilitating strategic partnerships.

The key elements of the proposal are: 1/ the establishment of  industrial 'Strategic Projects' in the EU to create, increase or modernise existing manufacturing capacity for critical medicines or their substances, or to contribute to the roll-out of a key technology in the manufacturing process, which will benefit from financial incentives, easier access to EU funds; 2/ measures related to public procurement to strengthen the resilience of supply chains of critical medicines or to improve access to other medicines of common interest; 3/ new international 'strategic partnerships' between the EU and a third country , a group of third countries or international organisations, to broaden the supply chain and reduce dependencies on single suppliers; 4/ collaborative procurements with notably the possibility for Member States to request Commission's support in the use of collaborative procurement tools (cross-border procurement) to address availability and access disparities of medicines of common interest; 5/ a 'Critical Medicines Coordination Group' to facilitate the implementation of the regulation.

The proposal was presented at Parliament on 11 March 2025 and to COREPER (Council) on 14 March 2025, and discussed at the informal meeting of the European health ministers on 25 March 2025.  A discussion took place on 20 June 2025 at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council. Health Ministers met informally in Copenhagen on 15-16 September 2025. 

In Parliament, a debate took place during SANT Committee meetings on 26 June, 1 September and 5 November 2025. More than 1300 amendments to the draft report have been tabled. The rapporteur is Tomislav Sokol (EPP, Croatia).  A vote on ENVI opinion took place on 4 November, followed by a vote on ITRE and IMCO opinions on 11 November. The vote in SANT committee on the draft report took place on 15 December 2025, with 27 votes in favour, 1 vote against, and 8 abstentions.

The European Economic and Social Committee adopted its opinion on 18 June 2025. In September 2025, the European Court of Auditors released a special report on the topic. The European Committee of the Regions adopted its opinion on 10 December 2025.

Parliament and Council have to adopt their positions before trilogues with the Commission can begin. The Council adopted a general approach on 2 December 2025. Parliament adopted its position on 20 January 2026 (503 votes in favour, 57 against and 108 abstentions).

It is one of the priorities of the Cyprus EU Presidency, as recalled by Cypriot Health Minister during the SANT Committee meeting of 2 February 2026.

The first round of trilogue negotiations took place on 2 February 2026. The next one is scheduled for 16 March.  

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Further reading:

Author: Laurence Amand-Eeckhout, Members' Research Service, legislative-train@europarl.europa.eu

As of 20/02/2026.