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Brokered In May, The Critical Medicines Act Still Needs Adoption

Basel: The Critical Medicines Act has cleared its political hurdle but not yet its legal one, because the provisional agreement reached by the Council and Parliament on 12 May 2026 still has to be endorsed and formally adopted. The Council says both institutions will adopt the regulation after legal and linguistic revision, and it gives no date for that step.

The proposed regulation aims to improve the availability and security of supply of essential medicines such as antibiotics, insulin and painkillers. The European Medicines Agency says the Union list covers more than 200 active substances for human use that are considered critical for health systems. The act complements the wider pharma package, which also deals with shortages and supply.

The path to the deal was short. The Council agreed its position on 2 December 2025, and Parliament adopted its own on 20 January 2026 by 503 votes to 57, with 108 abstentions. The first trilogue took place on 2 February, and the Cyprus Presidency listed the file as a priority. Four months later, negotiators had a text.

Several tools sit at the heart of the Critical Medicines Act. The Council’s position cut the minimum number of member states needed for a joint procurement request from nine to six, and it required that resilience criteria take precedence over price when authorities evaluate bids for critical medicines. Parliament’s summary adds strategic projects with financial incentives, international partnerships and a coordination group to oversee implementation.

The reason the Critical Medicines Act is urgent is dependence. A 2021 Commission study found that 80 percent of imported pharmaceutical ingredients come from five countries, China, the United States, the United Kingdom, Indonesia and India, and that China alone accounts for 45 percent. In January 2023, the EMA warned of an amoxicillin shortage in several member states, which showed how quickly a gap in a basic antibiotic can reach pharmacies.

The medicines agency has already prepared for its role under the Critical Medicines Act. Its Executive Steering Group on Shortages and Safety of Medicinal Products is assessing a first set of medicines from the list, and the agency is expanding the European Shortages Monitoring Platform. It welcomed the proposals on state aid and joint procurement, which fall outside its remit but shape how fast manufacturers can build capacity.

For pharmaceutical companies in Basel and other production hubs, the details of the final Critical Medicines Act text will decide how much support they can claim. For patients, nothing changes until the regulation is adopted, published and applied. Until then, the act remains a promise on paper, and the formal votes in Parliament and Council are the next test of that promise.