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ENTWURF EINES BERICHTS (COM(2025)0102 – C100048/2025 – 2025/0102(COD))

Über den Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates zur Schaffung eines Rahmens für die Stärkung der Verfügbarkeit von und der Sicherheit der Versorgung mit kritischen Arzneimitteln sowie der Verfügbarkeit und der Zugänglichkeit von Arzneimitteln von gemeinsamem Interesse und zur Änderung der Verordnung (EU) 2024/795

SANT-PR-775742

Ausschuss für öffentliche Gesundheit · Rapporteur: Tomislav Sokol

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The draft report proposes amendments to the Commission's regulation on critical medicinal products, aiming to strengthen supply security and availability, and to improve access to medicinal products of common interest. It introduces a Union coordination mechanism for redistribution of stocks, a Union Stockpile, and strategic projects for manufacturing, with streamlined permitting and financial support. Procurement rules favour suppliers manufacturing in the EU, with multi-winner approaches and non-price criteria, while safeguarding competition and the internal market.

Committee position. The rapporteur proposes amendments to the Commission's proposal, introducing new mechanisms for coordination, stockpiling, and procurement, and modifying definitions and obligations.

Key points

  1. The regulation's objectives include supporting competitiveness and promoting measures that avoid unintended consequences for supply continuity and patient access.
  2. A list of medicinal products from third countries with no adequate Union substitute will be established and updated to monitor dependencies.
  3. Strategic projects may include those creating or increasing manufacturing capacity for critical products or common interest products, but not if they duplicate existing capacity without justification.
  4. Member States must designate authorities to assess strategic projects within 90 days, and the Commission will issue guidelines for consistent assessment.
  5. Strategic projects are considered in the public interest, with accelerated permitting and a one-stop-shop for Union funds.
  6. Member States must provide administrative and technical support to strategic projects, including mitigating energy supply interruptions, and may exempt essential employees from military service.
  7. Environmental impact assessments for strategic projects must be concluded within 30 days, and such projects shall be considered of overriding public interest under certain directives.
  8. A Union coordination mechanism is established for monitoring availability and ensuring equitable redistribution of critical products during shortages.
  9. Binding redistribution decisions require prior approval by the Critical Medicines Group, based on risk assessment, and ensure transferring states retain minimum stock levels.
  10. Member States must report monthly on stockpiles via a digital system, and comply with redistribution decisions or face infringement procedures.
  11. A Union Stockpile may be established as a last resort, with delegated acts defining categories, quantities, and deployment criteria.
  12. Procurement procedures must include multi-winner approaches, non-price criteria, and favour EU-based suppliers, with derogations only if duly justified.

Who is affected

  • Marketing authorisation holders and economic operators must provide information and comply with obligations related to supply and stockpiles.
  • Member States are responsible for designating authorities, establishing national programmes, and reporting on stockpiles.
  • Strategic project promoters benefit from streamlined permitting and potential financial support.
  • Patients and patient organisations are involved in the Critical Medicines Group and benefit from improved availability.

Figures and deadlines

  • 90 days from entry into force for designating authorities.
  • 6 months for assessment of strategic project requests.
  • 30 days for issuing reasoned conclusions on environmental impact.
  • 50% of active ingredient or value must be produced in the EU for 'significant proportion'.
  • 18 months for Commission guidelines on non-price criteria.
  • 6 months after entry into force for national programmes.
  • 60 days for reimbursement after transfer.
  • Two-thirds majority of Member States for redistribution decisions.

Legal basis: Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union