On 4 September 2025, the European Parliament’s Committee on the Environment, Climate and Food Safety (ENVI) considered its draft opinion on the Commission’s proposal for a Critical Medicines Act, first presented on 11 March 2025. The initiative seeks to strengthen the EU’s manufacturing capacity for essential medicines by encouraging investment and promoting more resilient supply chains.
A central feature of the proposal is the creation of “strategic projects,” which would benefit from simplified access to funding and fast-tracked administrative, regulatory and scientific support. The goal is to reduce Europe’s reliance on external suppliers and safeguard the availability of medicines considered indispensable for public health.
In earlier legislative files, such as the Net-Zero Industry Act (NZIA) and the Critical Raw Materials Act (CRMA), ENVI held exclusive competences in areas concerning permit-granting procedures, particularly where these touched on environmental assessments and compliance with environmental law. With this precedent in mind, the Committee requested and obtained authorisation to deliver an opinion under Rule 57 of the Parliament’s Rules of Procedure.
The draft opinion discussed on 4 September reflects ENVI’s role in ensuring that measures to boost EU pharmaceutical production remain compatible with environmental standards. The Committee’s contribution will feed into the wider parliamentary debate, ahead of final negotiations between the European Parliament, the Council and the Commission.
