The European Parliament and the Council have reached an agreement on reducing shortages of critical medicines.

The European Parliament and the Council have reached a provisional agreement on new rules for reducing shortages of critical medicines and supporting pharmaceutical production in the EU.

In short

The provisional agreement targets critical medicines such as antibiotics, insulin, vaccines, and treatments for chronic or rare diseases. The new rules aim to reduce dependence on countries outside the EU and increase the competitiveness of the European pharmaceutical sector. The text establishes criteria for strategic industrial projects in the EU, aimed at creating, modernizing, and expanding production capacities. Contracting authorities will need to apply procurement requirements that support the diversification of supply sources for critical medicines and active substances. The Commission will need to initiate a procurement procedure on behalf of the member states if at least five countries request this.

Negotiators from the European Parliament and the Council reached a provisional agreement on Tuesday morning on new rules aimed at reducing shortages of critical medicines in the European Union.

The text aims to ensure a high level of public health protection by reducing dependence on countries outside the EU and by increasing the competitiveness of the European pharmaceutical sector.

The new rules will apply to critical medicines. Several provisions also aim to improve access to medicines of common interest, meaning products that are not available in sufficient quantities to meet the needs of patients in several member states.

MEPs secured the inclusion of the possibility for orphan medicines, used to treat rare diseases, to benefit from strategic projects and collaborative procurement opportunities.

The agreement establishes criteria for creating strategic industrial projects located in the European Union. These are expected to create, modernize, and expand production capacities for critical medicines.

Companies that benefit from national or European financial support will have to comply with clear obligations, including prioritizing the supply of the EU market.

Contracting authorities in the Union will be required to apply procurement requirements that support the diversification of supply sources for critical medicines and their active pharmaceutical ingredients.

For critical medicines whose supply heavily depends on third countries, contracting authorities will be able to stimulate manufacturing in the EU through several flexible options.

Among these options is compensating suppliers proportionally to the share of medicines and active pharmaceutical ingredients manufactured in the European Union.

The agreement also provides for voluntary collaborative procurement. The European Commission will be required to initiate a procurement procedure on behalf of the member states when at least five countries request this.

The Commission will also be able, on its own initiative, to invite member states to form a joint request.

"With today's agreement, we firmly place patients' interests at the center, strengthen Europe's resilience, and boost the competitiveness of our pharmaceutical sector," said rapporteur Tomislav Sokol.

He stated that the introduction of collaborative procurement at the EU level represents a concrete measure to address shortages and ensure supply security.

"At the same time, we send a clear signal that Europe is determined to strengthen its pharmaceutical production base. Companies that produce medicines in Europe will be favored in procurement procedures. Strategic projects will benefit from access to national and European funding and from faster and more efficient authorization procedures," Sokol added.

Adam Jarubas, chair of the Public Health Committee, stated that the act on critical medicines is closely linked to the pharmaceutical package and represents the "missing piece" of the EU's response to medicine shortages, following the creation of the list of critical medicines and the Alliance for Critical Medicines.

According to him, the new rules implement the Pharmaceutical Strategy for Europe and mark an important milestone for the European Health Union.

The provisional agreement must be approved by the European Parliament and the Council before the new rules can come into force.

The European Commission presented a proposal for a regulation on critical medicines, including antibiotics, insulin, vaccines, and medicines for chronic diseases, in March 2025.

The initiative aims to strengthen the availability of these products in the European Union, in a context where medicine shortages have become a recurring problem for health systems and patients.

According to data mentioned in the European Parliament document, over 50% of reported medicine shortages are caused by production issues, including shortages of active substances. The act on critical medicines is linked to other European instruments in the field, including the list of critical medicines, the Alliance for Critical Medicines, and the pharmaceutical package.

For the European Union, the file has a double stake: ensuring the availability of essential treatments for patients and strengthening European industrial capacity in a sector considered strategic for public health and competitiveness.