The European Commission has presented a draft of a new Critical Medicines Act. Its goal is to address the serious shortage of medicines and healthcare products and reduce external dependence on critical drugs and ingredients. Currently, 80% of active pharmaceutical ingredients (APIs) used in the EU for drug production come from Asia, primarily China and India. This makes the European pharmaceutical market vulnerable to crises, including those of a political nature.
“The pandemic and war have shown that Europe must restore its capacity to produce medicines or establish reliable supply chains with countries we can consider allies. The Critical Medicines Act includes measures aimed at enhancing the production capacity of European pharmaceutical companies and encouraging collaboration. Additionally, through reimbursement systems, member states will be able to jointly purchase medicines, increasing their influence on pricing,” said Dr. Adam Jarubas, a Member of the European Parliament from the Polish People’s Party, in an interview with Newseria.
The COVID-19 pandemic highlighted the role of the pharmaceutical industry in ensuring the production, availability, and affordability of medicines in Europe. This particularly applies to critical medicines such as antibiotics, anticoagulants, oncology drugs, and cardiovascular treatments. These drugs often have limited or no alternatives. The primary issue concerns the production of critical medicines and the active pharmaceutical ingredients (APIs) required for their manufacture. According to EU data, up to 80% of APIs used in Europe and around 40% of finished medicines sold in the region originate from China or India. The growing dependence of the EU on API imports has led to a partial loss of its independent production capacity. The proposed Critical Medicines Act aims to change this situation.
“A clear example was during the pandemic when it became evident that over 80% of paracetamol was produced in India. When supply chains broke down, these essential substances and medicines became scarce. Europe now understands that pharmaceutical security is one of the most crucial factors for overall security. We also recognize that in Ukraine, during the war, people are dying not only on the battlefield but also in hospitals due to a lack of medicines. This highlights that pharmaceutical security is just as important as military, food, and digital security,” explained Dr. Adam Jarubas.
On March 11, during a plenary session of the European Parliament, the principles of the Critical Medicines Act were presented. The new regulations aim to facilitate investments by pharmaceutical companies through easier access to financing and more favorable legislation. Strategic projects related to drug production will also be eligible for public funding.
A wide range of experts has long called for EU funding to support European pharmaceutical production capacity. The necessary investment costs are considered too burdensome for national healthcare systems in individual member states. Large-scale cost savings in production can only be achieved when manufacturing serves a broader economic area, such as the entire EU.
“There are measures aimed at increasing the production capacity of domestic European companies and encouraging them to collaborate. Additionally, through reimbursement systems, member states will be able to jointly purchase medicines, strengthening their ability to influence pricing. There are still some undefined financial instruments in the act. As Members of Parliament, we were keen to ensure that this legislation does not merely allow member states to incur debt or relax state aid regulations, but also includes other supportive elements. We will continue working on this,” emphasized the MEP.
The proposed budget in the draft act is approximately €88 million for the period from 2026 to 2027. This amount roughly corresponds to the estimated costs of repatriating a single active ingredient of an antibiotic. The Critical Medicines Act covers around 280 active ingredients, meaning the allocated financial resources may be insufficient to fully reduce dependence on Asia.
“We certainly need more flexibility and simplified regulations, but also financial instruments. That is why, in the European Parliament, we will push for not only national instruments—as the act allows member states to invest—but also European support mechanisms. This is particularly crucial for critical substances where supply chain gaps have been identified. We must stimulate financial support, including funding to restore the production of these substances and medicines within Europe,” emphasized Dr. Adam Jarubas.
