Proposal for a New Critical Medicines Act in the EU
Why is the Commission proposing a Critical Medicines Act?
The Commission's proposal is a response to persistent challenges related to medicine shortages across the EU and recent geopolitical tensions, which have exposed structural weaknesses in the EU’s pharmaceutical supply chains and highlighted the need to strengthen manufacturing resilience and reduce external dependencies.
What does the Critical Medicines Act propose?
The proposed CMA sets out a new governance framework with measures aimed at strengthening the security of supply and the continuous availability of critical medicines in the EU. It also introduces targeted industrial policy tools to incentivise manufacturing initiatives that enhance EU-based production of critical medicines. Key components of the CMA include recognition and support for strategic projects, as well as public procurement instruments designed to improve supply chain resilience.
The scope of the CMA is primarily focused on critical medicines on the Union List of Critical Medicinal Products, first published in December 2023 and reviewed in 2024. The list identifies medicines based on disease severity and the lack of therapeutic alternatives and serves as a basis for assessing supply vulnerabilities.
The proposal complements the ongoing reform of the EU’s pharmaceutical legislation and builds on the enhanced role of the European Medicines Agency in managing shortages.
Some of the key elements of the proposal are further outlined below.
Strategic projects to boost EU-based manufacturing
As part of its industrial policy approach, the CMA introduces a framework for the designation and support of strategic projects. These are industrial initiatives located in the EU that contribute to strengthening manufacturing capacity for critical medicines, their active substances or essential inputs. Projects may focus on capacity expansion, site modernisation, or the deployment of technologies that support resilient and sustainable pharmaceutical production.
Recognised strategic projects may benefit from facilitated access to funding, faster permitting procedures, and targeted regulatory support. This may include projects aimed at improving sustainability, increasing efficiency or applying key enabling technologies in pharmaceutical manufacturing. To qualify, a project must meet specific criteria set out in the CMA. Each Member State will designate a competent authority responsible for assessing whether a project meets these criteria.
Public procurement initiatives
The CMA introduces new EU-level procurement initiatives based on three distinct mechanisms: "Commission-facilitated Member States’ cross-border procurement", "Commission procurement on behalf of or in the name of Member States", and "joint procurement". These mechanisms are directly linked to the Union List of Critical Medicines and "medicines of common interest", ensuring that procurement efforts target areas of genuine need. It is noted in this connection that there is currently no publicly available specific list of "medicines of common interest".
The procurement initiatives formalise and expand the EU’s existing procurement toolbox by clearly defining participation thresholds, procedural timelines, and assessment criteria. This more structured approach to procurement reflects the CMA’s broader goal of ensuring timely, equitable and secure access to medicines across the EU.
In parallel, the Commission encourages Member States to adapt procurement practices to support resilience - for instance by taking into account supply security and diversification of sources when awarding public contracts. For certain critical medicines, national authorities would also be required to give preference to suppliers with EU-based manufacturing, where justified by supply chain vulnerabilities.
Industry response
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has expressed support for the initiative, particularly its emphasis on collaboration, innovation and a risk-based approach to strengthening supply resilience. A recent article from MedWatch summarises the perspectives of key Danish stakeholders who all support the initiative in general, including industry representatives. Read the article here (in Danish, requires subscription).
What is next?
The proposal is subject to the ordinary legislative procedure and will be debated by the Council and the European Parliament. The proposal is expected to be adopted in the fourth quarter of 2025, with implementation starting in 2026. While its content may evolve, the Commission has made clear that strengthening pharmaceutical preparedness in the EU is now a key policy priority.
Read the European Commission's press release