Work on the EU’s Critical Medicines Act is entering the home stretch. Negotiations have begun between the European Parliament and EU member state governments, led by the Cypriot Presidency, to determine the final shape of the document. Under the new regulations, the priority is to reduce dependence on active substance supplies from third countries and increase the competitiveness of the EU pharmaceutical sector. Boosting drug production within the European Union is considered crucial for public health security.
“As patients and healthcare users, we are often unaware that drug production has largely moved out of Europe, primarily to Asia—specifically China and India,” says Dr. Adam Jarubas, Member of the European Parliament (PSL) and Chairman of the parliamentary Subcommittee on Public Health (SANT). “In some substance categories, especially those used to produce medicines, up to 80% of the most important, frequently purchased pharmacy preparations are made there. Learning from the pandemic crisis, when supply chains broke down, we should do everything possible to rebuild production capacities in Europe to have critical substances available locally.”
The Challenge of Dependency
According to European Commission data, the EU is heavily reliant on imports of Active Pharmaceutical Ingredients (APIs).
-
80% of APIs come from just five countries: China, the USA, the UK, Indonesia, and India.
-
Imports from China alone account for 45% of supplies.
-
Between 2022 and 2023, half of the recorded drug shortages in pharmacies were due to production issues, including raw material shortages.
“We see what is happening today in economic relations—the world as we knew it is shaking, including relations with the US and Asia,” Dr. Jarubas explains. “There is no shortage of potential conflicts. We want to become resilient to various crises, blockades, sanctions, and tariff wars. We simply want to be able to produce active substances in Europe so that our patients are safe.”
The Critical Medicines Act (CMA)
The response to these vulnerabilities is the Critical Medicines Act (CMA), proposed by the European Commission in March 2025. These “critical medicines” are preparations with no equivalents, where insufficient supply would cause serious harm or risk to patients—including antibiotics, insulin, vaccines, and treatments for chronic diseases.
In January, the European Parliament adopted a report from the Public Health Committee regarding the proposed laws.
“The European Commission’s proposal aims to help attract drug production to Europe, facilitate investment, and enable joint drug procurement by member states,” the MEP notes. “The goal is for Europe to regain its drug production capabilities within a few years or establish ‘friendly’ relationships with suppliers who can be considered reliable partners.”
Key Provisions and the “Buy European” Approach
Members of the European Parliament (MEPs) support creating “Strategic Projects” to modernize and improve manufacturing capacity across member states. They are calling for priority financial support in the current budget and the upcoming Multiannual Financial Framework.
Under these proposals:
-
Public Procurement Reform: Price can no longer be the sole criterion for awarding drug contracts.
-
New Criteria: Security of supply, production chain resilience, and manufacturing capacity within the EU must be prioritized.
-
Strategic Autonomy: A “Buy European” approach is intended to ensure long-term supply security.
Opportunities for Industry
“For the industry, primarily the generics sector which dominates in countries like Poland and Central-Eastern Europe, this is a massive opportunity to gain from administrative simplifications and joint procurement,” says Dr. Jarubas.
There are also discussions regarding a “Critical Medicines Fund.” This would go beyond administrative easing, potentially allowing member states to use their own funds as state aid to support domestic plants, backed by a central EU financial incentive. Health Commissioner Olivér Várhelyi has not ruled out the creation of such a fund to co-finance the restoration of critical substance production in Europe.
Finally, the European Parliament’s report calls for an EU coordination mechanism for national and emergency stockpiles of critical medicines. MEPs also want the Commission to have the power, as a last resort, to redistribute drugs from one national stockpile to others in the event of severe shortages or supply disruptions.
