The Critical Medicines Act is close to the finish line, with Parliament and Council negotiators having struck a provisional deal in the early hours of 12 May 2026. The text now needs formal endorsement from both institutions before it can enter into force. The European Parliament’s legislative tracker gives an indicative plenary date at the end of November 2026.
The law responds to years of shortages of antibiotics, painkillers and other basic treatments across the Union. The Commission tabled the proposal on 11 March 2025, and the Council agreed its general approach on 2 December 2025. Parliament adopted its own position on 20 January 2026 by 503 votes to 57, with 108 abstentions.
The Critical Medicines Act changes how hospitals and health authorities buy essential drugs. Contracting authorities must apply resilience-related requirements in public procurement of critical medicines. For products that depend heavily on suppliers outside the Union, buyers can reward companies in proportion to the share of the medicine and its active ingredients made in the EU.
Industrial policy sits at the heart of the file. The agreement confirms the criteria for designating EU-based strategic projects that build, modernise or expand capacity for critical medicines and their active substances. Companies that receive national or EU money for such projects must meet clear conditions, including prioritising supply to the EU market.
Joint buying also becomes easier under the Critical Medicines Act. The threshold for triggering a collaborative procurement request to the Commission falls from nine member states to five. Orphan medicinal products, which treat conditions affecting no more than five in 10,000 people, now fall inside the scope of both strategic projects and collaborative procurement.
Stockpiling produced the sharpest trade-off, and the Critical Medicines Act stops short of a full EU stockpile. Parliament wanted a mandatory EU mechanism to coordinate national contingency stocks, but information sharing stays voluntary. Member states will instead use the existing voluntary solidarity mechanism to share data on contingency stock needs and to move critical medicines to where they are most urgently required.
The committee trail shows broad support. The Council’s Coreper approved the deal on 30 June 2026, and Parliament’s health committee endorsed it on 14 July 2026 by 33 votes to one, with two abstentions. Those margins suggest the final plenary vote should pass comfortably, although the Council still has to adopt the text and no date has been published.
Industry and patient groups will now focus on implementation. The Commission has to turn the procurement criteria into practical guidance, and national authorities must decide how much weight to give EU-made supply in tenders. Law firms advising pharmaceutical companies expect publication in the Official Journal towards the end of 2026, with the application date still to be confirmed.
Predictable demand helps manufacturers plan production. The Critical Medicines Act tries to supply that predictability through joint tenders and quality-based award criteria rather than the lowest price alone. Whether national buyers embrace that shift will decide how much the law changes day-to-day supply.
For patients, the real test is whether pharmacies stop running out of everyday medicines. The Critical Medicines Act cannot end shortages overnight, because new manufacturing capacity takes years to build. Yet it gives governments a clearer toolkit, and the final vote in Parliament will show whether the Union keeps its promise to secure medicine supply.
