On the proposal for a regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795
A-10-2025-0272
Committee on Public Health · Rapporteur: Tomislav Sokol
- Voted on · Adopted 503–57–108 · See the decision →
- Full procedure 2025/0102
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Parliament's amended version of the proposed regulation aims to strengthen the security of supply and availability of critical medicinal products and improve access to medicinal products of common interest in the EU.¶¶ It introduces strategic projects to boost EU manufacturing, with fast-track permits and financial support, and requires public procurement to use criteria beyond price, favouring EU production where vulnerabilities exist.¶¶¶ It establishes a Union coordination mechanism for redistributing stocks during shortages, a possible Union Stockpile, and a Critical Medicines Coordination Group to oversee implementation.¶¶¶
Committee position. The Committee on Public Health proposes amendments to the Commission proposal to strengthen EU manufacturing, streamline permits, enhance coordination, and introduce new mechanisms for redistribution and stockpiling.¶¶¶
Key points
- Strategic projects for manufacturing critical medicines or their inputs must meet criteria like creating or modernising capacity; they are considered in the public interest and get accelerated permits.¶¶¶
- Member States must designate authorities to assess strategic projects within three months; the Commission provides guidelines and a central webpage for promoters.¶¶¶
- Strategic projects get administrative and technical support, including help with permits and priority for inspections; Member States must ensure adequate staff and resources.¶¶¶
- Environmental assessments for strategic projects can be combined, with conclusions due in 45 days (extendable by 45), without lowering standards.¶¶¶
- Member States shall prioritise financial support for strategic projects addressing supply vulnerabilities; beneficiaries must prioritise EU supply and may face penalties for non-compliance.¶¶¶
- Union funding for strategic projects is allowed under current and future frameworks, with a critical medicines security fund proposed; a one-stop-shop coordinates awards.¶¶¶
- Public procurement of critical medicines must use award criteria beyond price, including supply resilience and diversification, with multi-winner approaches where feasible; criteria favour EU production when dependency is confirmed.¶¶¶
- Member States must establish national programmes for supply security, including procurement measures, and notify them to the Critical Medicines Group.¶¶
- A Union coordination mechanism enables binding redistribution of critical medicines from national stocks during shortages, with appeal and reimbursement provisions.¶¶¶
- A Union Stockpile may be established as a last resort for persistent shortages, with delegated acts defining products, quantities, and deployment.¶
- The Commission shall facilitate joint procurement for medicines of common interest upon request of three or more Member States, and may procure on behalf of five or more.¶¶¶
- The Critical Medicines Group includes Member States, the Agency, patient and healthcare professional representatives, and European Parliament observers; it coordinates implementation and issues recommendations.¶¶¶
Who is affected
- Pharmaceutical manufacturers and project promoters can apply for strategic project status, gaining faster permits and access to financial support.¶¶
- Contracting authorities in Member States must apply new procurement criteria favouring supply security and EU production.¶¶
- Member States must designate authorities, establish national programmes, and report on stockpiles; they may be subject to redistribution decisions.¶¶¶
- Economic operators in supply chains may be required to hold contingency stocks and provide information to authorities.¶¶
Figures and deadlines
- Three months for Member States to designate authorities and for assessment of strategic projects.¶¶
- 45 days for environmental impact assessment conclusions, extendable by 45 days.¶
- Five or more Member States can request Commission joint procurement, down from nine.¶¶
- At least 50% of active substance or value must be from the EU to count as significant production.¶¶
- Quarterly reporting on national stockpiles and contingency stocks.¶
- Reimbursement for redistributed medicines within 30 days of receipt.¶
Legal basis: Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union¶