Critical Medicines Act

The language versions will be available for download as the translations are completed.

Practical Information: 

• Composition of the Study Group:
• Administrator: Jacopo Ernesto CAJA / Santiago DIAZ-DE-VILLEGAS LE BOUFFANT
• Contact: e-mail

Key points

The EESC:

•    recommends significantly increasing funding to support the objectives of the Critical Medicines Act. A dedicated European fund should be established for starting materials, Active Pharmaceutical Ingredients (APIs), and critical medicines, with contributions from Member States, the EIB and private actors. Funding should support EU-based production, R&D for sustainable technologies, and offset cost disadvantages with non-EU producers;

•    calls for the creation of a fully interoperable EU-wide database to integrate national systems, provide real-time visibility of supply chain vulnerabilities, and ensure cybersecurity protection. Funding should be allocated to real-time tracking, early warning systems, and digital technologies to predict shortages and improve crisis responses;

•    highlights the need for a comprehensive, evidence-based impact assessment of the Critical Medicines Act, in parallel with legislative work and without delaying the adoption of the Regulation, covering the full supply chain and addressing the socio-economic impacts,

•    believes that the EU should invest in large-scale upskilling and reskilling initiatives and establish competence centres, alongside expanded financial support for vocational education, apprenticeships, university programmes, and industry-aligned training;

•    recommends carrying out an analysis on the proposal to integrate the Critical Medicines Act into the EU’s broader strategic autonomy and security framework, recognising pharmaceutical supply chains as a matter of public health and European security;

•    calls for strong measures to guarantee the affordability of critical medicines, including those for rare diseases, by introducing mechanisms to regulate medicine pricing, enhance transparency, and prevent price increases for consumers.