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DRAFT OPINION (COM(2025)0102 – C100048/2025 – 2025/0102(COD))

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

IMCO-PA-776854

Committee on the Internal Market and Consumer Protection · Rapporteur: Marion Walsmann

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This draft opinion proposes amendments to the proposed Critical Medicines Act regulation to reinforce resilience, coherence, and legal certainty in the supply of critical medicinal products. It prioritises reforming procurement to favour security of supply over lowest price, strengthening joint procurement, clarifying sustainability criteria, and supporting a European preference system. Amendments include defining 'significant proportion' as at least 25% of annual production volume in the EU, allowing exemptions from diversification where not feasible, and merging Articles 22 and 23 on procurement.

Committee position. The rapporteur welcomes the Commission proposal but proposes targeted amendments to strengthen resilience, improve coherence, and increase legal certainty, focusing on procurement reform, joint procurement, sustainability criteria, and a European preference system.

Key points

  1. Procurement procedures should prioritise security of supply, stability of deliveries and fair competition, with flexibility for multi-winner procedures and exemptions for orphan medicines.
  2. Joint procurement initiatives should be streamlined to avoid duplication and ensure coherence with existing tools.
  3. Sustainability criteria must not conflict with the primary aim of securing supply; a systematic assessment of interactions is required.
  4. A European preference system should be designed to remain compatible with international obligations and avoid protectionism.
  5. Strategic projects should benefit from streamlined processes and targeted regulatory support, with attention to SMEs and small mid-cap enterprises.
  6. Procurement requirements should include stockholding obligations, monitoring of supply chains for bottlenecks, transparency, and contract performance clauses; diversification requirements must be proportionate and allow exemptions where not feasible.
  7. A significant proportion of production of critical medicinal products or APIs for the Union market should be located in the Union, defined as at least 25% of annual production volume.
  8. Contracting authorities shall apply procurement requirements favouring suppliers manufacturing a significant proportion of critical medicinal products in the Union, and for other medicinal products of common interest where justified.
  9. Additional qualitative requirements should aim to improve supply chain security and availability, not environmental sustainability or social rights.
  10. Derogations from procurement requirements are allowed exceptionally if application would lead to disproportionately high prices, with written justification and possible ex-post review.
  11. Article 22 on Commission procurement is deleted and merged with Article 23 on joint procurement, which now allows the Commission to procure on behalf of Member States under certain conditions.
  12. The Critical Medicines Group should assess the impact of environmental and other legislation on medicine availability and may recommend regulatory exemptions for short-term redistribution.

Who is affected

  • Contracting authorities in member states: must apply new procurement requirements favouring EU-based suppliers and may grant exemptions.
  • Manufacturers of critical medicinal products and medicinal products of common interest: face requirements to produce a significant proportion in the EU.
  • Small and medium-sized enterprises and small mid-cap enterprises: should have a fair chance to initiate strategic projects.
  • The Commission: responsible for assessing procurement requests and ensuring coherence with international obligations.

Figures and deadlines

  • at least 25% of the annual production volume of a critical medicinal product, a medicinal product of common interest, or their API, intended for the Union market, must be manufactured within the Union