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Critical Medicines Act

COD - Ordinary legislative procedure (ex-codecision procedure)2025/0102(COD)Committee: Public HealthDG: [SANTE] Health and Food Safety

Policy topics

"Buy European" provisions (generic)Government stockpiling of critical medicinesJoint EU procurement of medicinesSupply chain diversification requirements in medicine procurementStrategic allocation vs. open market in medicine procurementEU funding for critical medicines development

What this file does

Overview

This analysis describes the policy context for the legislative file "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" (2025/0102(COD)). The file is in the 1st reading stage and its overall status is ongoing. The European Parliament's status is 'Awaiting committee decision' following a plenary vote. The analysis is based on the provided European Parliament document (P10_TA(2026)0001), which is a consolidated summary of amendments, alongside data on procedural history, institutional handling, and stakeholder engagement.

Legislative timeline

The legislative procedure began with the referral to the European Parliament's committee on 2025-05-21. The committee work involved multiple stages, including the tabling of the committee report on 2025-07-18, the tabling of several committee opinions in September 2025, and the tabling of committee amendments in September and October 2025. Key committee opinions were adopted in November 2025, followed by the adoption of the committee report on 2025-12-15. The file was subsequently tabled for plenary session on multiple dates in December 2025 and January 2026. Recent plenary events on 2026-01-20 included amendments, a vote, and a referral back to committee for the purpose of interinstitutional negotiations.

Institutional handling

The lead committee in the European Parliament is the Committee on the Environment, Public Health and Food Safety (Public Health). Within the European Commission, the responsible department is the Directorate-General for Health and Food Safety (SANTE), under Commissioner Olivér Várhelyi. In the Council of the EU, the relevant configuration is the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO).

Stakeholder reactions

Stakeholder engagement with policymakers on this file has been extensive, with a recorded 263 meetings held with Members of the European Parliament. These meetings involved 141 distinct organisations. The most active organisations in this outreach were MEDICINES FOR EUROPE, the European Federation of Pharmaceutical Industries and Associations, Johnson & Johnson, AbbVie, and A. Menarini Industrie Farmaceutiche Riunite s.r.l.

Media coverage

No data on media coverage was provided for this file.

Institutional status

CommissionOngoing
ParliamentAwaiting Parliament's position in 1st reading
CouncilFirst reading

Official documents (19)

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