The European Commission proposes a new regulation to strengthen the supply and availability of Critical Medicines

In January 2024, at the initiative of the European Commission and driven by the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW), the Critical Medicines Alliance (CMA) was established as a consultative mechanism bringing together relevant stakeholders from EU Member States (MS), including key industries, civil society, and the scientific community. The Alliance aims to identify key areas and action priorities, proposing solutions to strengthen the supply of critical medicines in the EU and ultimately improve efforts to prevent and effectively address shortages.

On February 28, 2025, the Alliance published a Strategic Report, which includes analysis and recommendations to improve the security and resilience of Critical Medicines supply chains in the EU.

The report highlights critical vulnerabilities within pharmaceutical supply chains in Europe and proposes substantial investment in strategic projects, procurement policies, and a harmonized and balanced framework of storage requirements to ensure supply security. It also recognizes the interconnected nature of pharmaceutical supply chains and recommends strengthening partnerships with third countries to enhance supply resilience.

In March 2025, the European Commission approved the proposal for a new regulation on Critical Medicines, aimed at strengthening the security of supply and availability of critical medicines in the EU, as well as improving the availability and accessibility of other medicines when market forces do not sufficiently ensure their access and availability. It is currently under review by the European Parliament and the Council of the European Union under the ordinary legislative procedure.

In this regard, the regulation will apply to critical medicines and medicines of common interest (including innovative products), as well as their active ingredients and key components.

Beyond definitions and objectives, the text, divided into chapters, outlines various proposals to strengthen the security of supply and availability of critical medicines in the EU. Below is an analysis of the proposals conducted by AseBio.

Creation of the Critical Medicines Coordination Group (GCMC)

The proposal establishes the GCMC, where each Member State may designate two high-level representatives, and the EMA would act as an observer member. The GCMC would facilitate coordination in the strategic guidance of financial support for strategic projects, exchanges on national procurement programs, and discussions on the need for joint procurement. Additionally, it would provide advice to the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on the prioritization of critical medicines for vulnerability assessment.

Creation of Strategic Projects

The text sets out the criteria and procedures for establishing strategic projects. Strategic projects must be designed by Member States, and a promoter may request their evaluation. The Commission will create a webpage with the contact details of the designated national authorities.

To be designated as a strategic project, projects located in the EU must meet at least one of the following criteria: 

• Create or increase the manufacturing capacity of one or more critical medicines, their active ingredients, or key inputs for their production.
• Modernize an existing manufacturing site for one or more critical medicines or their active ingredients (enhancing sustainability or increasing efficiency).
• Contribute to the deployment of a technology that plays a key role in manufacturing one or more critical medicinal products, their active ingredients, or key inputs.

National, regional, and local authorities must review zoning and land use plans to facilitate the development of strategic projects. In this regard, Member States must ensure that all relevant spatial planning data is available. If the plans include provisions for the development of strategic projects subject to assessment under Directive 2001/42/EC and Article 6(3) of Directive 92/43/EEC, such assessments must be combined. This evaluation may also consider other impacts, such as those on potentially affected water bodies or the marine environment (including land-sea interactions).

Funding for Strategic Projects

Member States may offer financial support to strategic projects addressing supply chain vulnerabilities, prioritizing the EU market for critical medicines. They may also request necessary supplies to prevent shortages.

The document foresees EU-level funding. Specifically, during the 2021–2027 Multiannual Financial Framework, strategic projects may receive EU funding through programs such as EU4Health, Horizon Europe, and the Digital Europe Programme, provided they support the objectives of these programs. Applications will be assessed by the designated authority within 15 days.

Finally, Member States will use the Critical Medicines Coordination Group (GCMC) to exchange information on funded projects and facilitate cooperation in their implementation.

Demand-Side Measures

The future regulation introduces criteria in procurement procedures (Directive 2014/24/EU) related to supply resilience in the EU. This includes, for example, supplier diversification, supply chain transparency, and performance clauses for timely delivery. It also aims to favor suppliers who manufacture a significant portion of critical medicines with supply chain vulnerabilities within the EU.

The document states that all Member States must establish a national program to support supply security, including procurement procedures, and notify the Commission within six months of the regulation's entry into force. This program aims to facilitate coordination and promote manufacturing within the EU.

To safeguard contingency stocks, it is proposed that supply security measures applied in one Member State should not have negative impacts on others, particularly regarding contingency stock requirements, which must be proportionate and transparent.

Through Articles 21–24, the text proposes various models for collaborative procurement within the EU.

International Strategic Partnerships

The Commission will explore the possibility of establishing strategic partnerships with the aim of diversifying the supply of essential medicines, active ingredients, and key starting materials to enhance supply security.

Amendments to Regulation (EU) 2024/795

The regulation amends the definition of "biotechnologies" in the STEP Regulation (activities eligible for funding under STEP) to include the manufacturing of essential medicines. It also allows STEP funding for strategic projects.