The European Council and European Parliament have reached a political agreement on the Critical Medicines Act, a landmark piece of legislation designed to reduce the EU’s dependence on single-source pharmaceutical suppliers, expand domestic production capacity and establish coordinated emergency stockpile mechanisms across member states.
EU Health Commissioner Olivér Várhelyi described the law as “Europe’s essential safety net,” saying it was designed to prevent shortages, reduce supplier concentration risk and strengthen local production to protect public health. “Patients in the EU must have access to the medicines they need, when they need them,” he said.
The agreed legislation contains four main components. On supply chain diversification, member states will be required to promote resilient and diversified pharmaceutical supply chains in public procurement procedures. Where high dependence on a single or limited number of third countries is identified, public contracting authorities must give preference to EU-manufactured products — a buy-European provision that mirrors approaches being taken in critical minerals and semiconductor policy.
On production capacity, the Act establishes a strategic projects mechanism to increase and modernise EU manufacturing of critical medicines and their active ingredients, with faster administrative support and easier access to financing. Projects producing medicines for rare diseases will benefit from accelerated approval processes.
For emergency stockpiles, member states requiring companies to maintain reserves must ensure this does not compromise supply to other EU countries. A voluntary solidarity mechanism will enable member states to share information on available stockpiles and redistribute them in the event of a shortage emergency. Joint procurement provisions aim to improve access to critical medicines and medicines for rare diseases across the bloc.
The agreement will now proceed to formal approval by both the European Parliament and the Council before entering into force.
