Nicosia: The Critical Medicines Act still needs formal endorsement from both the Council and the European Parliament, almost six months after negotiators struck a provisional deal. Under the Cyprus Presidency, the two institutions reached political agreement in the early hours of 12 May 2026 on the Commission’s proposal, COM(2025) 102, which targets recurring shortages of critical medicines such as antibiotics, insulin and painkillers.
Procurement sits at the centre of the Critical Medicines Act. Contracting authorities must apply resilience-related requirements when they buy critical medicines, so that supply comes from more than one source. For medicines that depend heavily on third-country suppliers, authorities may reward suppliers in proportion to the share of the medicine and its active substances made in the EU.
The deal also confirms criteria for strategic projects that create, modernise or expand manufacturing capacity for critical medicines and their active substances. Companies that receive national or EU financial support face clear conditions, including priority for supplying the EU market. That condition links public money directly to security of supply for European patients.
Joint buying becomes easier. The number of member states needed to submit a joint request for collaborative procurement to the Commission falls from nine to five. Orphan medicines, defined by law as treating conditions affecting no more than 5 per 10,000 people in the EU, also fall within the scope of the Critical Medicines Act for strategic projects and collaborative procurement.
Stockpiling shows the limits of the compromise. Parliament wanted a mandatory EU coordination mechanism for national stockpiles, but information sharing stays voluntary. New measures cover the exchange of information on contingency stock needs, and the existing voluntary solidarity mechanism will share stock data and reallocate critical medicines between member states where needed.
The legal calendar remains loose. Law firm analysis expects the text to appear in the Official Journal towards the end of 2026, with the application date still to be confirmed. The European Medicines Agency is assessing vulnerabilities for the first medicines on the Union list of critical medicines, and the Critical Medicines Act complements the EU pharmaceutical reform package, which is due in the Official Journal later this year.
Patients and hospital pharmacists will judge the Critical Medicines Act by shelves, not by clauses. If member states endorse the text without reopening it, the new procurement rules and the lower joint buying threshold could ease shortages within a few years; if the formal votes drag into 2027, the shortages that prompted the proposal will continue.





