The Critical Medicines Act has a political deal but no final law yet. Negotiators from Parliament and Council reached provisional agreement in the early hours of 12 May 2026, and the text still has to clear several formal steps before the Official Journal publishes it. Law firm McCann FitzGerald expects publication towards the end of 2026, with the application date still to be confirmed.
The Critical Medicines Act has 31 articles and applies directly in every member state. Its stated aim is to prevent medicine shortages, secure supply, cut dependence on production sites outside the EU and expand European capacity for critical medicines and active pharmaceutical ingredients. The Commission tabled the proposal only about a year before the deal, which is fast for a health file.
The scope of the Critical Medicines Act grew during talks. Besides the Union List of Critical Medicines, the Critical Medicines Act now covers Medicinal Products of Common Interest. Orphan medicines, defined as treatments for conditions affecting no more than five in 10,000 people in the EU, should benefit from strategic projects and joint procurement. Parliament did not extend the scope to contraceptive and abortive medicines.
Joint purchasing became easier. The Commission can now launch joint procurement when five member states ask for it, down from nine in the original draft, although participation stays voluntary. Stockpiling remains mainly a national responsibility, and information-sharing on contingency stocks stays voluntary through the existing solidarity mechanism, which the text is expected to clarify further.
Procurement rules in the Critical Medicines Act attract the most commercial interest. Hospitals and health authorities may no longer judge tenders on price alone, and they must apply resilience requirements for critical medicines. For products that depend heavily on third-country suppliers, authorities can reward bidders in proportion to the share of the medicine and its ingredients made in the EU.
The German social insurance office in Brussels calls the final compromise considerably more flexible than Parliament’s proposal and closer to the Council position. It says the wording of Article 18 on procurement will decide how much room contracting authorities keep, and the final text was not public in the sources reviewed.
Strategic projects form the supply side of the Critical Medicines Act. The deal confirms the criteria for designating EU-based projects that build, modernise or expand capacity, and companies that receive national or EU support face requirements, including giving priority to the EU market.
The next steps follow a fixed order. The Committee of Permanent Representatives must endorse the deal, Parliament’s public health committee must approve it, and lawyer-linguists must revise and translate it into all official languages. Only then do Parliament and Council adopt it formally, and neither source reported a date for those votes.
Manufacturers, hospitals and patient groups should use the gap before the Critical Medicines Act applies to prepare. Companies can map their supply chains against the Union list, procurement officers can review tender templates, and patient organisations can watch how orphan medicines fare under joint purchasing. The European Medicines Agency is already assessing supply weaknesses for the first medicines on the Union list.
Until the Official Journal publishes it, the Critical Medicines Act remains a promise rather than a rulebook. Its success will depend on how member states apply the resilience criteria and whether the voluntary tools deliver real supply security.
