BRUSSELS, BELGIUM / EuroWire / — European Union negotiators reached a provisional agreement on Tuesday on new rules designed to curb shortages of vital medicines, backing a package that would expand production capacity in Europe, diversify supply chains across the EU and make it easier for EU member states to buy critical drugs together. The agreement on the Critical Medicines Act comes as the bloc seeks to strengthen supplies of medicines such as antibiotics, insulin, vaccines and some treatments for chronic and rare diseases.
The provisional deal between the Council of the European Union and the European Parliament would require resilience-related criteria in public procurement for critical medicines and their active ingredients. It also allows contracting authorities to favor stronger European supply chains in cases where the bloc is highly dependent on third countries for supply. The measure is aimed at addressing repeated shortages that EU institutions have linked in large part to manufacturing problems and concentrated production outside the bloc.
Negotiators also agreed to support industrial strategic projects inside the EU to create, modernize or expand manufacturing capacity. Under the terms outlined by the European Parliament, projects receiving national or EU financial backing would face obligations including prioritizing supply to the EU market. The law’s scope would also extend, in selected areas, to orphan medicines used for rare diseases, widening access to measures such as strategic project status and collaborative purchasing.
Procurement and production measures
Another provision lowers the threshold for joint procurement requests to the European Commission, allowing it to launch a purchasing procedure when at least five member states ask it to act on their behalf, down from nine in the original proposal. The Commission would also be able to encourage countries to make a joint request. EU lawmakers say the change is intended to strengthen collective bargaining power and help smaller markets secure access to critical medicines on more even terms.
The agreement also introduces safeguards around contingency stocks, requiring stockpiling measures to be transparent and to respect solidarity and proportionality across the single market. Member states would be able to exchange information on emergency reserves, and an existing voluntary mechanism could be used to help reallocate critical medicines between countries when needed. The Council of the European Union said the rules are designed to prevent national stock requirements in one country from worsening shortages elsewhere in the bloc.
Stockpiles and next steps
The package builds on a proposal the European Commission put forward in March 2025 as part of broader efforts to reinforce medicine security within the European Health Union. That proposal sought to improve the availability, supply and production of critical medicines and other products of common interest, including some medicines for rare diseases that are not sufficiently available in several markets. The European Medicines Agency maintains the Union list of critical medicines, which has helped shape the scope of the legislation and the wider policy response to shortages.
The Council agreed its negotiating position in December 2025 and Parliament adopted its mandate in January 2026. Tuesday’s accord is provisional and still requires formal approval from both the European Parliament and the Council before the regulation can enter into force after legal and linguistic review. Once adopted, the law would become the EU’s central framework for addressing medicine shortages through procurement rules, production support and cross-border coordination on critical supplies.