In a result that caught many off guard, EU negotiators emerged in the early hours of Monday morning (11 May), after 12 hours of negotiations, having reached a political agreement on the Critical Medicines Act (CMA). The Cypriots secured the deal just in time, which is seen as quite a significant win for Nicosia ahead of its handover to the upcoming Irish Presidency in July 2026.
What was Agreed?
On Public Procurement: “Made in EU” will feature in public procurement, however, not to the extent that the Parliament wanted. The agreement will provide flexibility for contracting authorities, giving multiple options, two of which include implementing the “EU preference” approach.
Collaborative Procurement: EU countries will be able to join forces when procuring critical medicines and medicines of common interest, in addition, the threshold of Member States needed for public procurement has been reduced from nine to five. IN addition, the article was removed allowing the Commission to participate in the joint purchasing of medicines.
On Definitions: The scope of definitions was expanded to include orphan medicines in certain key areas, including strategic projects and collaborative procurement.
On Stockpiling: Any contingency stock requirements should be transparent and respect the principles of solidarity and proportionality. There have also been new measures introduced allowing Member States to share relevant information about contingency stock requirements.
In addition, the agreement clarifies the use of the existing voluntary solidarity mechanism (VSM) in ensuring that data on the contingency stocks is exchanged between Member States and providing the means for countries to reallocate critical medicine products, if needed, on a voluntary basis.
What they Said
The Council was clear in its assessment stating that the “new rules seek to diversify supply chains of critical medicines, make it easier for EU countries to join forces to procure critical medicines, and strengthen the manufacturing capacity for critical medicines and their active ingredients within the EU.”
Meanwhile, the Commission was equally forthcoming, welcoming what was described a “landmark political agreement on the CMA…the CMA will promote the diversification of supply chains and support pharmaceutical manufacturing within the EU, while enabling Member States to cooperate more closely to improve access to medicines in Europe.”
What’s Happens Next?
The provisional CMA agreement will now have to be endorsed by both the Council and the European Parliament. A plenary vote is required but timing remains uncertain.
Deals that arrive unexpectedly, such as this one, often do so because the finer points of the text still need to be worked through in the days and weeks that follow. The realistic expectation is that a plenary vote is unlikely before the summer, meaning autumn is the more probable timeframe.
The Critical Medicines Act (CMA) was first proposed by the European Commission in March 2025, against the backdrop of post-pandemic supply chain vulnerabilities and growing concern about Europe’s reliance on third countries such as China and India for active pharmaceutical ingredients.
