Early on Tuesday morning, Parliament and Council negotiators reached a provisional deal on new rules seeking to ensure a high level of public health protection for EU citizens by reducing dependency on non-EU countries and boosting the competitiveness of the EU pharmaceutical sector.
The rules will apply to critical medicines, with several provisions also aiming to improve access to medicinal products of common interest (MPCI – medicines that are not sufficiently available to cover patients’ needs in several countries). MEPs ensured that orphan medicinal products (needed to treat rare diseases) can benefit from strategic projects and collaborative procurements opportunities.
Funding for strategic projects
The agreed text establishes the criteria for setting up industrial “strategic projects’” located in the EU to create, modernise and increase manufacturing capacity. Companies benefiting from national or EU financial support will have to meet clear obligations, including prioritising supply to the EU market.
Procurement policy that supports EU production
Contracting authorities in the EU will be required to apply procurement requirements that support the diversification of supply sources for critical medicines and their active pharmaceutical substances. For critical medicines whose supply is highly dependent on third countries, contracting authorities will be able to incentivise their manufacturing in the EU through several flexible options. These include rewarding suppliers proportionally to the share of medicinal products and their active pharmaceutical substances manufactured in the EU.
Voluntary collaborative procurements
The agreement foresees that the Commission will be required to initiate a procurement procedure on behalf of Member States, when five or more countries request it. The Commission may, on its own initiative, also invite Member States to form a joint request.
Quotes
Rapporteur Tomislav Sokol (EPP, HR) said: “Through today’s agreement we are placing patients’ interests firmly at the centre, strengthening Europe’s resilience and boosting the competitiveness of our pharmaceutical sector. By introducing collaborative procurement at EU level, we are taking concrete action to address shortages and ensure security of supply. At the same time, we are sending a clear signal that Europe is committed to strengthening its pharmaceutical manufacturing base. Companies that produce medicines in Europe will be favoured in procurement procedures. Strategic projects will benefit from access to national and EU funding and from faster and more efficient permitting procedures.”
Public Health Committee Chair Adam Jarubas (EPP, PL) said: “The Critical Medicines Act is closely linked to the pharmaceutical package, the missing piece of the EU’s response to medicines shortages following the creation of the critical medicines list and the Critical Medicines Alliance. It implements the Pharmaceutical Strategy for Europe and marks a milestone for the European Health Union. It means greater medicines security for the Europeans, but it will also be an essential support for EU’s reindustrialisation and competitiveness.”
Next steps
The provisional agreement needs to be approved by both Parliament and Council before the new rules can enter into force.
Background
In March 2025, the Commission made a proposal for a regulation on critical medicines (such as antibiotics, insulin, vaccines, and medicines for chronic diseases) to shore up their availability in the EU. Over 50% of reported medicine shortages are caused by manufacturing issues, including shortages in active substances.
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