Laying a 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, and amending Regulation (EU) 2024/795

Wording as published by the EP, in English.

1. Amendment 244 · Draft legislative actRejected

   Recital 3 a (new)

   Tabled by Catarina Martins, Anthony Smith · The Left

   Added: (3 a) Shortages of medicines disproportionately affect women, particularly in areas such as reproductive health, maternal health, menopause treatment, and female cancers. This Regulation should take into account the gender impact and provide for specific measures to address gender inequalities and safeguard equitable access to medicines.

2. Amendment 247 · Draft legislative actRejected

   Recital 22 a (new)

   Tabled by Catarina Martins · The Left

   Added: (22 a) On 9 March 2025, 11 Union Health Ministers signed a letter stating that the Critical Medicines Act must be expanded into an effective, full-scale strategic programme, backed by EU defence funding, to secure the continent’s strategic autonomy and that anything less would be a grave miscalculation that could turn the Union's dependence on critical medicines into the Achilles’ heel of Europe’s security. In that context, it is essential that the Critical Medicines Act and the newly proposed Critical Medicines Security Fund act as robust instruments and that part of their funding be embedded in broader EU defence spending plans, including the financial mechanisms in the new Rearm Europe Plan.

3. Amendment 250 · Draft legislative actRejected

   Article 16 – paragraph 2 a (new)

   Tabled by Anthony Smith, Catarina Martins · The Left

   Added: 2 a. Undertakings benefiting from Union funding must comply with sectorial collective agreements, offer good working conditions and decent wages. They shall not be allowed to distribute excessive dividends, resort to tax heavens, or proceed with collective layoffs and shall reimburse public funding received in case of non-compliance with their obligations. They shall also comply with their obligations related to social and environmental reporting. Undertakings that do not comply with labour law and health and safety regulations shall not be able to benefit from direct public subsidies and shall be excluded from public procurement tendering procedures.

4. Amendment 256 · Draft legislative actAdopted

   Recital 12 a (new)

   Tabled by Vlad Vasile-Voiculescu · Renew

   Added: (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.

5. Amendment 257 · Draft legislative actAdopted

   Article 3 – paragraph 1 – point 5

   Tabled by Vlad Vasile-Voiculescu · Renew

   … Member States the functioning of the market does not sufficiently ensure the Removed: availability Added: availability, affordability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member Removed: States; Added: 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;

6. Amendment 259 · Draft legislative actRejected

   Recital 4

   Tabled by Ondřej Knotek, Marie-Luce Brasier-Clain, Viktória Ferenc +6 · PfE

   (4) Industrial Removed: challenges Added: challenges, burdensome EU environmental legislation and a lack of investments in manufacturing capacities in the Union have … third country suppliers, in particular, for key raw pharmaceutical materials and active Removed: substances. Added: substances imported from China and India. Setting up new, Added: expanding or modernising existing manufacturing capacities in the Union for critical medicinal products, … pharmaceutical manufacturing further add to the industrial challenges to manufacturing in the Removed: Union. Added: Union, along with high energy prices caused mainly by the EU Green Deal. Targeted financial incentives, simplified administrative processes, Added: reduction of environmental obstacles, coordination with chemical and environmental legislation, and better Union-level coordination can contribute to supporting efforts to increase manufacturing capacities in the Union and strengthen the supply chains for critical medicines. Added: This Regulation aims to strengthen the manufacturing base of the Members States, promote reshoring, and reduce the dependency on third countries in order to enhance Union’s competitiveness, while ensuring patients’ access to medicinal products.