Schaffung eines Rahmens für die Stärkung der Verfügbarkeit von und der Sicherheit der Versorgung mit kritischen Arzneimitteln sowie der Verfügbarkeit und der Zugänglichkeit von Arzneimitteln von gemeinsamem Interesse und Änderung der Verordnung (EU) 2024/795

Wortlaut wie vom EP veröffentlicht, auf Englisch.

1. Änderungsantrag 244 · Entwurf eines GesetzgebungsaktsAbgelehnt

   Recital 3 a (new)

   Eingereicht von Catarina Martins, Anthony Smith · The Left

   Hinzugefügt: (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. Änderungsantrag 247 · Entwurf eines GesetzgebungsaktsAbgelehnt

   Recital 22 a (new)

   Eingereicht von Catarina Martins · The Left

   Hinzugefügt: (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. Änderungsantrag 250 · Entwurf eines GesetzgebungsaktsAbgelehnt

   Article 16 – paragraph 2 a (new)

   Eingereicht von Anthony Smith, Catarina Martins · The Left

   Hinzugefügt: 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. Änderungsantrag 256 · Entwurf eines GesetzgebungsaktsAngenommen

   Recital 12 a (new)

   Eingereicht von Vlad Vasile-Voiculescu · Renew

   Hinzugefügt: (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. Änderungsantrag 257 · Entwurf eines GesetzgebungsaktsAngenommen

   Article 3 – paragraph 1 – point 5

   Eingereicht von Vlad Vasile-Voiculescu · Renew

   … Member States the functioning of the market does not sufficiently ensure the Entfernt: availability Hinzugefügt: availability, affordability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member Entfernt: States; Hinzugefügt: 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. Änderungsantrag 259 · Entwurf eines GesetzgebungsaktsAbgelehnt

   Recital 4

   Eingereicht von Ondřej Knotek, Marie-Luce Brasier-Clain, Viktória Ferenc +6 · PfE

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