EU reaches provisional agreement on Critical Medicines Act, strengthening focus on European medicine production

EU negotiators have reached a provisional agreement on the Critical Medicines Act, a landmark piece of legislation designed to strengthen Europe’s pharmaceutical supply chains and reduce reliance on external manufacturing for critical medicines and ingredients .

The agreement introduces new procurement rules that allow member states to favour medicines manufactured in Europe rather than selecting suppliers solely on the basis of lowest price. The legislation also supports the development of strategic manufacturing projects within the EU and aims to diversify supply chains following growing concerns about Europe’s dependence on production in countries such as China and India.

Another significant element of the deal is the inclusion of orphan medicines within the scope of the legislation, potentially enabling greater support for innovative and specialised treatments through state aid and collaborative procurement mechanisms.

The Act reflects a wider strategic shift in EU health and industrial policy. In recent years, European institutions have increasingly linked medicine security, health innovation, and competitiveness, arguing that Europe needs stronger internal capacity not only to secure access to essential medicines, but also to support research, clinical development, and advanced pharmaceutical manufacturing within the region.

The final compromise was reached after lengthy overnight negotiations between the European Parliament and the Council under the Cyprus Presidency of the EU. While some of the Parliament’s stronger “made in Europe” provisions were softened during negotiations, the final text still marks a significant step toward a more active EU approach to pharmaceutical resilience and strategic production capacity.