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 A10-0272/253

Amendment 253

Michele Picaro, Francesco Torselli, Mariateresa Vivaldini, Aurelijus Veryga, Ruggero Razza

on behalf of the ECR Group

Report A10-0272/2025

Tomislav Sokol

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

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

Proposal for a regulation

Recital 42 a (new)

Text proposed by the Commission

Amendment

(42 a) The availability of critical medicines might be affected by Union legislation in other sectors, in particular environmental legislation such as the Urban Wastewater Treatment Directive. In order to ensure coherence and avoid unintended consequences leading to shortages, it is important to assess the impact of such measures on the supply of medicines.

Or. en

14.1.2026 A10-0272/254

Amendment 254

Michele Picaro, Francesco Torselli, Mariateresa Vivaldini, Aurelijus Veryga, Ruggero Razza

on behalf of the ECR Group

Report A10-0272/2025

Tomislav Sokol

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

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

Proposal for a regulation

Article 12 a (new)

Text proposed by the Commission

Amendment

Article12a

Coordination with environmental and chemical legislation

The Commission and the Member States shall ensure that the application of this Regulation is coordinated with existing and forthcoming environmental and chemical legislation to prevent unintended restrictions on the manufacturing and availability of critical medicinal products and ensure the future availability of critical medicinal products, while maintaining the best possible environmental and health standards.

Where such legislation is likely to create substantial barriers to the continued production or availability of critical medicinal products, the Commission shall conduct a coordinated impact assessment and consult with the Critical Medicines Coordination Group, the Member States and relevant stakeholders to propose mitigating actions including possible regulatory proposals.

Or. en

14.1.2026 A10-0272/255

Amendment 255

Michele Picaro, Francesco Torselli, Mariateresa Vivaldini, Aurelijus Veryga, Ruggero Razza

on behalf of the ECR Group

Report A10-0272/2025

Tomislav Sokol

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

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

Proposal for a regulation

Article 30 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Commission shall carry out a yearly assessment of the impact of the Urban Wastewater Treatment Directive, and in particular of the extended producer responsibility provisions set out in Article 9 and 10 thereof and Annex III thereto, on the availability or security of supply of critical medicines in the Union. Where such assessments identify a negative impact on the availability of critical medicines, Member States shall temporarily suspend the application of the extended producer responsibility provisions until appropriate mitigating measures are adopted.

Or. en