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 A10-0272/259

Amendment 259

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

on behalf of the PfE 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 4

Text proposed by the Commission

Amendment

(4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. Setting up new, or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages and the need for specialised skills in pharmaceutical manufacturing further add to the industrial challenges to manufacturing in the Union. Targeted financial incentives, simplified administrative processes, 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.

(4) Industrial challenges, burdensome EU environmental legislation and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances imported from China and India. Setting up new, expanding or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages and the need for specialised skills in pharmaceutical manufacturing further add to the industrial challenges to manufacturing in the Union, along with high energy prices caused mainly by the EU Green Deal. Targeted financial incentives, simplified administrative processes, 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. 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.

Or. en

14.1.2026 A10-0272/260

Amendment 260

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

on behalf of the PfE 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 30 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Commission shall regularly monitor the coordinated application of this Regulation with environmental and chemical legislation to prevent unintended restrictions on the manufacturing and availability of critical medicinal products. Where such legislation is likely to create substantial barriers to the continued production or availability of critical medicinal products, the Commission shall carry out a coordinated impact assessment and consult with the Critical Medicines Group to propose appropriate mitigating actions, including, where appropriate, legislative proposals.

Or. en