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DRAFT OPINION (COM(2025)0102 – C100048/2025 – 2025/0102(COD))

On the proposal for a regulation of the European Parliament and of the Council 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

ITRE-PA-774586

Committee on Industry, Research and Energy · Rapporteur: Oliver Schenk

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This draft opinion amends the proposed regulation on critical medicines to strengthen supply security, competitiveness, and innovation in the EU pharmaceutical sector. It calls for inclusive governance, better use of existing data tools, and support for strategic projects, including via State aid and the STEP instrument. It emphasizes protecting confidential information, promoting international partnerships, and easing access for SMEs and small mid-caps.

Committee position. The rapporteur proposes amendments to enhance the regulation's effectiveness, focusing on governance, strategic projects, funding, and international cooperation.

Key points

  1. Adds Article 173 TFEU as legal basis to support industrial capacity and reduce strategic dependencies.
  2. Stresses that shortages can undermine national security and the broader economy, and calls for addressing root causes.
  3. Calls for coherence between environmental and health policies to avoid undermining pharmaceutical production.
  4. Requires leveraging existing data infrastructures and avoiding duplication with other EU laws.
  5. Strategic projects must be deemed in the public interest and benefit from streamlined permitting, with attention to SMEs and SMCs.
  6. Public support for strategic projects may include State aid, which should be proportionate and transparent.
  7. Extends STEP to cover biomanufacturing as a key enabling technology.
  8. Ensures confidentiality of sensitive information and protects trade secrets.
  9. Promotes international partnerships to diversify supply and align standards with third countries.
  10. Requires the Critical Medicines Group to involve stakeholders and integrate findings from the Critical Medicines Alliance.

Who is affected

  • Pharmaceutical manufacturers, including SMEs and SMCs, will benefit from simplified procedures and support.
  • Member States must designate single authorities and ensure adequate resources for permit processes.
  • Third-country manufacturers exporting to the EU must meet equivalent standards.

Legal basis: Articles 114 and 173 of the Treaty on the Functioning of the European Union