Critical medicines: new measures to strengthen security of supply

Boosting investment in new and existing EU manufacturing capacity

Critical medicines security fund

Stimulate cross-border procurements

Covers medicines such as antibiotics, insulin, vaccines, medicines for chronic diseases

Over 50% of reported medicine shortages are caused by manufacturing issues

On Monday evening, Parliament’s public health committee adopted its proposals to enhance the availability of key medicines in the EU.

The draft bill, adopted with 27 votes in favour, one against and eight abstentions, aims to ensure a high level of public health protection for EU citizens by reducing the EU’s dependency on third countries and boosting the competitiveness of its pharmaceutical sector.

Strategic projects and access to dedicated funding

The draft text supports the creation of industrial “strategic projects'” in the EU to create, modernise and improve manufacturing capacity for critical medicines or their base substances. To promote a coordinated EU approach and to ensure legal certainty for project promoters, MEPs want the Commission to adopt guidelines for the assessment of projects.

The report requires the EU, including through regional funding, and EU member states to prioritise financial support for strategic projects. MEPs also want a dedicated “critical medicines security fund” to be established within the EU’s next multiannual financial framework (MFF).

Boost collaborative procurement of innovative, high-cost medicines

MEPs want public procurement procedures to allow for the award of contracts to multiple suppliers for the same product to promote diversification of supply and ensure that production is distributed across different manufacturers and geographical locations within the EU. Contracting authorities should apply procurement requirements that favour producers manufacturing a significant proportion of critical medicines in the EU.

The report highlights the benefits of voluntary collaborative procurements (e.g. three or more EU countries acting together, or joint procurement involving the Commission and at least five or more EU countries) to improve supply, notably for rare diseases medicines, antimicrobials, and other innovative, high-cost, or specialised treatments.

Coordination and redistribution of national stockpiles

MEPs call for the creation of an EU coordination mechanism for national stockpiles and contingency stocks of critical medicines. They also want the Commission to have the power to decide on, as a last resort, the redistribution of medicines from one national stockpile to one or more other countries, in instances where a shortage or a supply disruption of a critical medicinal product has been identified.

Quote

Rapporteur Tomislav Sokol (EPP, HR) said: “Today’s vote is a defining moment for Europe’s health security. We are committed to strengthening the availability and supply of critical medicines for all EU citizens. We are tackling persistent shortages and reducing our dependence on a limited number of external suppliers. The report sets out the strategic projects, collaborative procurement, and incentives needed to boost EU pharmaceutical manufacturing, while ensuring fair access to essential medicines like antibiotics, insulin, and pain treatments. It would bring us closer to a resilient, independent, and patient-centric pharmaceutical ecosystem that delivers stability and better care across the EU.”

Next steps

Parliament’s position is expected to be adopted during the January 2026 plenary session, after which negotiations with EU governments can begin.

Background

In March 2025 the Commission put forward a proposal for a regulation on critical medicines, to strengthen their availability in the EU. The proposal also aims to improve access to certain medicines of common interest that encounter market failures. Over 50% of reported medicine shortages are caused by manufacturing issues, including shortages in active substances.