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

Tabled by Ondřej Knotek, Marie-Luce Brasier-Clain, Viktória Ferenc, Margarita de la Pisa Carrión, Valérie Deloge, Aldo Patriciello, Tomáš Kubín, Aleksandar Nikolic, Ton Diepeveen

(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.

Wording as published by the EP, in English. PE781.998