The European Union has reached a provisional agreement on new legislation intended to strengthen the supply of critical medicines, after repeated shortages exposed the bloc’s dependence on fragile global pharmaceutical supply chains.
The deal on the Critical Medicines Act was reached between the Council presidency and the European Parliament on 12 May. It still requires formal approval by both institutions before the regulation can enter into force.
The proposed law is aimed at improving the availability of medicines considered essential for public health, including antibiotics, insulin and painkillers. It seeks to reduce the risk of shortages by diversifying supply chains, supporting production capacity in the EU and allowing member states to coordinate procurement where common action would improve access.
Medicine shortages have become a recurring concern across the EU, particularly for generic drugs and products whose production depends on a limited number of suppliers outside Europe. The Covid-19 pandemic, disruptions to global transport and rising production costs added pressure to supply chains that were already concentrated in a small number of countries.
Under the provisional agreement, EU countries will be able to join forces when purchasing critical medicines and medicines of common interest. The Council said the threshold for member states requesting the Commission to procure on their behalf had been reduced from nine to five, making joint procurement easier to initiate.
The regulation is also designed to support strategic projects linked to the production of critical medicines and their active pharmaceutical ingredients. These projects could benefit from faster administrative procedures and improved access to funding. The aim is to encourage investment in EU-based manufacturing without requiring the bloc to produce every medicine domestically.
The European Commission, which proposed the legislation, presented the agreement as part of a broader effort to prevent shortages and reduce excessive reliance on single suppliers or narrow supply chains. The measure forms part of a wider pharmaceutical agenda that includes reform of EU medicines rules and measures to improve access to treatments across member states.
A key element of the agreement concerns public procurement. Rather than focusing only on the lowest price, contracting authorities will be able to take supply security into account when buying critical medicines. This reflects a long-standing concern that intense price competition in generic medicines has contributed to the relocation of production outside Europe, leaving health systems exposed when supply chains are disrupted.
The agreement also contains flexibility around the so-called EU preference approach. This is intended to allow contracting authorities to consider European supply resilience while avoiding rigid procurement rules that could reduce competition or increase costs unnecessarily.
The European Medicines Agency welcomed the political agreement, saying the measure would strengthen Europe’s capacity to improve the availability, supply and production of critical medicines. The agency has already been given an expanded role in monitoring shortages, and the new act is intended to complement those regulatory tools with industrial and procurement measures.
The legislation does not remove the need for international supply chains. Many critical medicines and ingredients are produced through complex networks involving manufacturers, chemical suppliers, packaging firms and distributors across several countries. The EU’s stated objective is therefore not full self-sufficiency, but greater resilience, better information and fewer single points of failure.
The issue has particular relevance for smaller member states, where shortages can be harder to manage because markets are less commercially attractive and alternative suppliers may be limited. Joint procurement and better coordination could help address some of those disparities, although implementation will depend on how member states use the new framework.
The Critical Medicines Act also has a security dimension. Several medicines on the EU’s critical list are important not only for routine healthcare, but also for emergency preparedness, intensive care, surgery, infectious disease management and crisis response. Shortages of antibiotics, anaesthetics or insulin can therefore have consequences beyond ordinary market disruption.
For pharmaceutical companies, the act could create new opportunities for investment in European production, but it may also add expectations around supply security and resilience. The balance between affordability, industrial policy and secure access will be central to how the law is applied.
The agreement comes as the EU seeks to strengthen several areas of strategic supply, including energy, defence, raw materials, semiconductors and pharmaceuticals. In each case, the policy objective is similar: to reduce exposure to external shocks without closing the European market or abandoning international partnerships.
The next step is formal adoption by the Council and the European Parliament. Once approved, the regulation will provide a legal basis for coordinated action on critical medicines, including strategic projects, joint procurement and supply-chain resilience measures.
The practical test will be whether the new framework can reduce shortages in real health systems. Patients and hospitals are unlikely to judge the law by institutional process, but by whether essential medicines are available when needed.
