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
ENVI-AD-775606
Committee on the Environment, Climate and Food Safety · Rapporteur: Michele Picaro
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The committee opinion proposes amendments to the regulation on critical medicines to boost EU manufacturing, streamline permits, and uphold environmental standards.¶ It calls for balanced coordination between pharmaceutical and environmental laws, transparent data access, and rapid activation of strategic projects.¶¶¶
Committee position. The committee proposes amendments to strengthen environmental and health safeguards, streamline procedures, and enhance transparency in the regulation.¶¶¶
Key points
- Permit processes for strategic projects must be fast-tracked while ensuring compliance with highest social, health and environmental standards.¶¶
- Environmental assessments can be streamlined but without undermining quality or lowering health and environmental protection.¶¶¶
- Competent authorities must issue reasoned conclusions on environmental impact within 45 days, extendable by 45 days in justified cases.¶
- Member States must ensure authorities have sufficient staff and resources for environmental obligations.¶¶
- All decisions on projects must be publicly available online, with all decisions for one project on the same website.¶
- Contracting authorities should use multi-winner procurements and qualitative criteria like patient impact, environmental sustainability, and supply chain diversity.¶
- Stockpiling systems should apply first-in-first-out and shelf-life extension to reduce waste, with guidelines on sustainable stockpiling.¶
- The Commission should assess impacts of other EU legislation on this regulation and propose mitigating measures if risks to supply are found.¶¶