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 A10-0272/256

Amendment 256

Vlad Vasile-Voiculescu

on behalf of the Renew 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 12 a (new)

Text proposed by the Commission

Amendment

(12 a) Contraceptives and abortifacient medicinal products are essential in safeguarding sexual and reproductive health rights, gender equality and the full enjoyment of fundamental rights everywhere in the Union. Shortages and supply disruptions affecting these medicinal products of common interest undermine patient safety and contribute to unequal access to healthcare across the Union. In order to safeguard sexual and reproductive health rights and equal access to contraceptive and abortifacient medicinal products for all women in the Union, Member States should ensure availability, affordability and security of supply of these medicinal products of common interest.

Or. en

14.1.2026 A10-0272/257

Amendment 257

Vlad Vasile-Voiculescu

on behalf of the Renew 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 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

(5) ‘medicinal product of common interest’ means a medicinal product, other than a critical medicinal product, for which in three or more Member States the functioning of the market does not sufficiently ensure the availability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member States;

(5) ‘medicinal product of common interest’ means a medicinal product, other than a critical medicinal product, for which in three or more Member States the functioning of the market does not sufficiently ensure the availability, affordability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member States or is designated as an orphan medicinal product pursuant to Article 67 of Regulation (EU).../... [reference to be added after adoption cf. COM(2023)193 final)], or as a contraceptive or abortifacient medicinal product;

Or. en