European Parliament Committee revised and amplified version of the draft Critical Medicines Act

On 15 December 2025, the European Parliament’s public health Committee, SANT, adopted its proposed version of the draft Critical Medicines Act. The version amplifies, and in some aspects diverges from, the text of the Act proposed by the European Commission.

‍Of particular interest, and in some circles concern, was the proposed expansion in the definition of “Medicinal Product of Common Interest” provided by the draft Act.  SANT proposes that the definition be extended to include medicinal products for which, in three or more EU Member States, the functioning of the market does not sufficiently ensure the affordability of the product in sufficient quantities and presentations to cover the needs of patients in those EU Member States and medicinal products that have been designated as an orphan medicinal product within the Orphan Medicinal Products Regulation.

SANT wishes to see creation, modernisation, and improvement in manufacture or medicinal products as a priority and the expansion of the scope of this aspect of the Act from manufacture of critical medicinal products to include medicinal products of common interest.

SANT proposes the establishment of a “critical medicines security fund” to support achievement of the objectives of the Act. The Committee also proposes creation of an EU coordination mechanism for national stockpiles and contingency stocks of critical medicines. The proposal would leave to the European Commission power to decide, as a last resort, on the redistribution of medicinal products from one national stockpile to one or more other EU Member States where a shortage or a supply disruption of a critical medicinal product has been identified.

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