The European Parliament's Public Health Committee voted on December 15 to adopt a position on the Critical Medicines Act. It pointed out the need to supplement the original version of the draft with broader guidelines for assisting countries in the production of critical medicines and the creation of a Critical Medicines Safety Fund within the next EU budget.
Critical Medicines Act: EP Health Committee wants fund and support for EU manufacturing
Published Dec. 17, 2025 07:51
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With 28 votes in favor, 1 against and 8 abstentions, Parliament's position was voted down, which is much more ambitious on issues of financing and demand-side measures for critical medicines than the original draft. The Act is to include incentives to increase pharmaceutical production in the EU.
Critical medicines in strategic projects
- Due to the price of critical medicines, their production in Europe is not always profitable, as the cost can be higher than importing finished products from Asia. However, it is difficult to calculate the price that would be paid in a situation where supplies from abroad are blocked. Therefore, instruments are needed to ensure the profitability and disposal of this production in the EU, explains Krzysztof Kopeć, president of the National Drug Manufacturers.
The assumptions of the Critical Medicines Act indicate that strategic industrial investments creating, expanding or modernizing EU critical medicines production capacity will be eligible for support. Strategic projects will receive expedited permitting procedures, streamlined environmental impact assessments, and administrative and scientific support. MEPs want strategic projects to also receive financial support from EU member states. A dedicated "critical medicines safety fund" under the next EU multiannual financial framework is also expected to finance them.
- It is very good news that Akt will be "armed" with a dedicated fund. Otherwise, the number of critical drugs produced in Europe would not have a chance to grow," Krzysztof Kopeć points out.
Price cannot be the only criterion
- The act indicates that price cannot be the only criterion for public payers to purchase a critical drug. It emphasizes the guarantee and security of supply, as well as supplier diversification, Krzysztof Kopeć explains.
The issues of guarantees and security of drug supply have become mandatory when setting prices.
MEPs also want the Critical Medicines Coordination Group (CMCG) to consult with industry and stakeholders, including the Critical Medicines Alliance, and determine what is needed to make recommendations and decisions work and produce the expected results. The group will also provide opinions and recommendations on the impact of other legislation on the availability of critical medicines.
The European Critical Medicines List has 276 items. There are 401 on the Polish one, 82 of which are manufactured in Poland.
- This vote is an important step in building the health security and drug sovereignty of Europe and Poland. This is a great merit of Adam Jarubas, chairman of the SANT Committee, and MEPs Kosma Zlotowski and Elżbieta Łukacijewska. The National Drug Manufacturers have been pushing for this legislation for years by petitioning the European Parliament on this issue," points out Grzegorz Rychwalski, vice president of the National Drug Manufacturers.
The Parliament's position is expected to be adopted at a plenary session in January 2026, after which negotiations with EU governments can begin.
Source: PZPPF
Topics
Akt o Lekach Krytycznych / bezpieczeństwo lekowe / Grupa Koordynacyjna Leków Krytycznych. / produkcja leków krytycznych / Krajowi Producenci Leków / Fundusz Bezpieczeństwa Leków Krytycznych / PZPPF / Komisja Zdrowia Publicznego Parlamentu Europejskiego / Adam Jarubas / cena leków krytycznych / Krzysztof Kopeć
