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

14.1.2026 A10-0272/258

Amendment 258

Christine Anderson

on behalf of the ESN Group

Report A10-0272/2025

Tomislav Sokol

(COM(2025)0102 – C10-0048/2025 – 2025/0102(COD))

Proposal for a regulation

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Or. en

Justification

The proposal exceeds the limits of Union competence in the field of public health and circumvents the safeguards laid down in the Treaties. While presented as an internal market measure under Article 114 TFEU, the Regulation establishes binding mechanisms that directly interfere with the organisation of national health systems, public procurement policy, and the allocation of public resources — areas for which the Treaties reserve primary responsibility to the Member States pursuant to Article 168(7) TFEU. The introduction of centralised and mandatory procurement mechanisms, strategic project designation, and coordinated national programmes goes beyond what is necessary to address cross-border market fragmentation and instead amounts to de facto harmonisation of national health and procurement policies. These concerns have been formally raised by national parliaments, including the French Senate and the Swedish Parliament, in reasoned opinions on subsidiarity. The proposal has not been sufficiently narrowed to address these objections. For these reasons, the proposal cannot be supported in its current form and should be withdrawn and reconsidered on a legally sound basis that fully respects the principles of subsidiarity and proportionality.