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ONTWERPADVIES (COM(2025)0102 – C100048/2025 – 2025/0102(COD))

Inzake het voorstel voor een verordening van het Europees Parlement en de Raad tot vaststelling van een kader voor de vergroting van de beschikbaarheid en voorzieningszekerheid van kritieke geneesmiddelen, en voor verbetering van de beschikbaarheid en toegankelijkheid van geneesmiddelen van gemeenschappelijk belang, en tot wijziging van Verordening (EU) 2024/795

ENVI-PA-775606

Commissie milieubeheer, klimaat en voedselveiligheid · Rapporteur: Michele Picaro

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Written by a language model from the full text only; every figure comes from the text. The paragraph links open the paragraph a statement rests on — check the text itself before relying on it.

This draft opinion proposes amendments to a regulation on critical medicines to boost EU manufacturing by fast-tracking permits, simplifying environmental assessments, and supporting strategic projects. It calls for coordination between pharmaceutical, environmental, and chemical legislation to prevent unintended supply disruptions while maintaining high environmental standards. It requires transparent, time-bound procedures with adequate resources for authorities, and public access to data online.

Committee position. The rapporteur proposes amendments to the proposed regulation to boost EU manufacturing, streamline environmental procedures, and ensure coordination with environmental and chemical legislation.

Key points

  1. Calls for a balanced regulatory framework to avoid environmental policies making EU production less competitive and exacerbating medicine shortages.
  2. Requires assessing cumulative impacts of environmental and chemical legislation on manufacturing and supply capacities of critical medicines.
  3. Allows streamlining environmental assessments for strategic projects without lowering the level and quality of environmental protection.
  4. Requires procurement rules to include quality, environmental sustainability, stockholding, supplier diversification, supply chain transparency, and performance clauses.
  5. Expands definition of innovative manufacturing process to include yield improvements and processes enhancing security, energy efficiency, and environmental performance.
  6. Allows coordinated or joint environmental procedures for strategic projects without affecting the content or quality of the impact assessment.
  7. Sets a 45-day deadline for issuing reasoned conclusions on environmental impact assessments after receiving information and completing consultations.
  8. Requires member states to ensure competent authorities have sufficient qualified staff and resources for their obligations.
  9. Requires the Commission to coordinate with environmental and chemical legislation and conduct impact assessments with the Critical Medicines Coordination Group to propose mitigating actions.
  10. Requires spatial planning data to be available online and combined assessments for plans, without affecting their content or quality.
  11. Requires decisions to be publicly available in an understandable manner, with all decisions on one project on the same website.

Who is affected

  • Pharmaceutical manufacturers in the EU benefit from streamlined permits and reduced regulatory burden.
  • National, regional, and local authorities must allocate resources and make data available online.
  • Public buyers of medicines must apply new procurement criteria.

Figures and deadlines

  • 45 days for issuing reasoned conclusions on environmental impact assessments.