The Council Presidency has sent a letter to the Chair of the European Parliament Committee on Public Health enclosing the final compromise text of a Regulation establishing a framework to strengthen security of supply and availability of critical medicinal products and medicinal products of common interest. The text was endorsed by the Permanent Representatives Committee on 30 June 2026.
The Regulation applies to critical medicinal products on the Union list, which builds on a 2024 list of 276 products, and to medicinal products of common interest, such as those for rare diseases, antimicrobials, and oncology. It introduces "strategic projects" to boost EU manufacturing capacity for critical medicinal products, which benefit from streamlined permit-granting, priority status, and potential classification as "protected customer" under Regulation 2017/1938 for gas supply. The Commission facilitates collaborative procurement procedures for critical medicinal products and medicinal products of common interest, including orphan medicinal products. Member States coordinate on contingency stock requirements, complementing existing obligations under Regulations (EU) 2022/123 and (EU) …/… (2023/0131(COD)). The Regulation does not apply to Member States' responsibilities for health service organisation and delivery and is without prejudice to Union competition law.
The Regulation creates a harmonised EU framework to address shortages by incentivising manufacturing investment, enabling joint procurement, and coordinating Member State actions, targeting both critical and common-interest medicinal products. The compromise text now awaits formal adoption by the European Parliament and the Council.
EU pharmaceutical manufacturers may benefit from streamlined permitting and priority status for strategic projects, but may face new compliance costs. EU patients gain improved access to critical medicines, reducing shortage risks. Member States coordinate on stock requirements, potentially reducing duplication but limiting national flexibility. EU taxpayers may see increased public spending on joint procurement and incentives, offset by potential cost savings from reduced shortages.