EU reaches agreement to address shortages of vital medicines

The European Parliament and the Council of the EU have reached a provisional agreement aimed at reducing the European Union’s dependence on medicine supplies from countries outside the bloc and boosting medicine production in Europe, according to the European Parliament.

The new measures are aimed at addressing shortages of critical medicines such as antibiotics, insulin, and vaccines, as well as medications for chronic and rare diseases.

The agreement was reached early Tuesday morning and is part of broader EU efforts to strengthen the so-called European Health Union and to increase the competitiveness of the European pharmaceutical industry.

According to the agreed text, the new rules will apply to critical medicines, while some measures will also cover medicines of “general interest”—products that are not available in sufficient quantities to meet patient needs in several member states.

MEPs also insisted that medicines for rare diseases should be able to benefit from the new mechanisms for strategic projects and joint public procurement.

One of the main objectives is to increase production capacity within the EU. To this end, “strategic projects” will be established—industrial initiatives to build, modernize, and expand the production of medicines and active substances in Europe.

Companies receiving European or national funding will be required to fulfill specific obligations, including prioritizing supplies for the European market.

The new rules also introduce a “Buy European” approach to public procurement. Contracting authorities in the EU will be required to promote supply diversification and give preference to manufacturers that produce medicines and active pharmaceutical ingredients in Europe.

For medications where the EU is heavily dependent on third countries, institutions will be able to stimulate European production through various mechanisms, including additional points in public procurement for companies with production facilities in the EU.

The agreement also provides for a mechanism for voluntary joint public procurement between member states. The European Commission will be required to initiate a joint procurement procedure if at least five countries request it. The Commission may also propose the creation of joint procurements on its own initiative.

The rapporteur for the legislation, Tomislav Sokol, stated that the agreement places patients at the center of European policy and strengthens the resilience of the pharmaceutical sector.

“By introducing joint public procurement at the EU level, we are taking concrete actions to address medicine shortages and ensure security of supply,” he stated.

The Chair of the European Parliament’s Committee on Public Health, Adam Jarubas, described the legislation as a key part of the European response to medicine shortage crises.

“This is an important milestone for the European Health Union. The law means greater security for European patients, but it will also support the re-industrialization and competitiveness of the EU,” he said.

To enter into force, the agreement must be formally approved by both the European Parliament and the Council of the EU.

The European Commission presented the proposal for the regulation in March 2025, after it became clear that over 50% of registered medicine shortages in the EU were related to manufacturing issues, including a lack of active substances.