The Critical Medicines Act gives the European Union its first dedicated legal toolkit against medicine shortages, and its central promise is simple: public buyers will be able to reward suppliers that make medicines and their ingredients inside Europe. Parliament and the Council struck a provisional deal on 12 May 2026 under the Cyprus presidency. The text still needs formal endorsement and legal-linguistic revision before it becomes law.
The core change sits in public procurement. Under the Critical Medicines Act, hospitals and health authorities must apply resilience requirements when they buy critical medicines, so price alone no longer decides who wins a tender. Buyers may give extra credit to bidders according to the share of finished medicines and active pharmaceutical ingredients made in the EU. The approach is flexible rather than mandatory, which leaves national authorities room to set the weighting.
The deal responds to a dependency that Commission analysis has documented for years. A 2021 Commission study found that 80% of imported pharmaceutical ingredients came from five countries, and China alone supplied 45%. Antibiotics have been the most visible casualty of fragile supply chains. Cyprus Health Minister Neophytos Charalambides said patients should never have to worry about whether antibiotics are available, and he argued that the agreement cuts vulnerabilities and brings production closer to home.
Manufacturing capacity gets its own track. The Critical Medicines Act creates strategic projects to build, modernise or expand pharmaceutical plants in the EU, with access to national and EU funding and faster permitting. Companies that take that money must accept obligations, including priority supply to the EU market. Orphan medicines, which treat life-threatening conditions affecting no more than five in 10,000 people, now fall under strategic projects and joint procurement, although they miss some financial and regulatory support.
Joint buying also becomes easier. Member states can ask the Commission to procure on their behalf once five countries join the request, down from nine, and the Commission may refuse only with substantiated reasons. Governments must exchange information on contingency stock needs and apply solidarity and proportionality when they set stockpiling measures. The existing voluntary mechanism lets countries reallocate scarce medicines during a shortage.
Parliament’s negotiators claimed the procurement shift as their win. Rapporteur Tomislav Sokol, an EPP lawmaker from Croatia, said companies producing medicines in Europe will be favoured in procurement. Adam Jarubas, who chairs the Parliament committee on public health, called the Critical Medicines Act the missing piece of Europe’s answer to shortages, following the critical medicines list and the Critical Medicines Alliance. He said it helps deliver the European Health Union.
Several details will decide whether the law works. Neither institution has published a euro figure for the funding behind strategic projects, and the weight that buyers give to EU origin will vary from one capital to the next. The act also sits beside the wider pharmaceutical package revision, which tackles shortages and supply management from another angle.
For patients and hospital pharmacists, the test will come in the first tenders after the Critical Medicines Act applies. If buyers use the resilience criteria seriously, the new rules could shift orders toward European plants and thin out the single-source risks that make shortages so damaging. If they keep chasing the lowest price, the Critical Medicines Act will stay largely on paper.
