Istituzione di un quadro volto a rafforzare la disponibilità e la sicurezza dell'approvvigionamento di medicinali critici, nonché la disponibilità e l'accessibilità dei medicinali di interesse comune, e modifica del regolamento (UE) 2024/795

Testo come pubblicato dal PE, in inglese.

1. Emendamento 244 · Progetto di atto legislativoRespinta

   Recital 3 a (new)

   Presentato da Catarina Martins, Anthony Smith · The Left

   Aggiunto: (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. Emendamento 247 · Progetto di atto legislativoRespinta

   Recital 22 a (new)

   Presentato da Catarina Martins · The Left

   Aggiunto: (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. Emendamento 250 · Progetto di atto legislativoRespinta

   Article 16 – paragraph 2 a (new)

   Presentato da Anthony Smith, Catarina Martins · The Left

   Aggiunto: 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. Emendamento 256 · Progetto di atto legislativoApprovata

   Recital 12 a (new)

   Presentato da Vlad Vasile-Voiculescu · Renew

   Aggiunto: (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. Emendamento 257 · Progetto di atto legislativoApprovata

   Article 3 – paragraph 1 – point 5

   Presentato da Vlad Vasile-Voiculescu · Renew

   … Member States the functioning of the market does not sufficiently ensure the Rimosso: availability Aggiunto: availability, affordability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member Rimosso: States; Aggiunto: 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. Emendamento 259 · Progetto di atto legislativoRespinta

   Recital 4

   Presentato da Ondřej Knotek, Marie-Luce Brasier-Clain, Viktória Ferenc +6 · PfE

   (4) Industrial Rimosso: challenges Aggiunto: 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 Rimosso: substances. Aggiunto: substances imported from China and India. Setting up new, Aggiunto: 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 Rimosso: Union. Aggiunto: Union, along with high energy prices caused mainly by the EU Green Deal. Targeted financial incentives, simplified administrative processes, Aggiunto: 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. Aggiunto: 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.