New rules for critical medicines in the EU
The critical medicines act addresses shortages of key medicines to better meet patient needs and improve the EU’s resilience to health crises.
What is the critical medicines act?
The critical medicines act is a proposal for a new EU regulation that aims to improve the availability and security of supply of essential medicines within the EU, including antibiotics, insulin, and painkillers.
The proposal seeks to make Europe’s healthcare system more resilient and self-sufficient to better withstand global health challenges that threaten access to essential medicines, such as pandemics, natural disasters and supply chain disruptions.
The new rules would complement the proposals to revise the EU’s pharmaceutical legislation (the ‘pharma package’), which also contain provisions on managing shortages and the supply of medicines.
The pharma package: new EU rules on medicines
What are considered critical medicines?
According to the European Medicines Agency (EMA), a critical medicine is defined by the seriousness of the disease it treats and the availability of alternative treatments. Additional criteria are also considered, such as the number of member states that consider it essential.
Critical medicines are crucial to the proper functioning of healthcare systems, particularly during health crises. Shortages of critical medicines could lead to serious health risks, treatment disruptions, or loss of life.
Examples of critical medicines include:
- antibiotics
- insulin
- painkillers
- vaccines
- medicines for chronic and acute diseases (e.g. cancer, heart conditions, diabetes)
What would change under the critical medicines act
In recent years, the EU has faced significant challenges due to shortages of vital medicines. These shortages have affected healthcare delivery, increased reliance on external suppliers, and disrupted health systems during critical times, especially in the wake of the COVID-19 pandemic.
The act aims to improve the availability, security, and resilience of the supply chain for essential medicines by:
diversifying the supply chain to reduce dependence on a limited number of suppliers
providing incentives for collaborative procurement to help member states purchase medicines more effectively and reduce costs
boosting EU pharmaceutical manufacturing to ensure that critical medicines are produced within the EU, reducing reliance on third countries
The role of active pharmaceutical ingredients
The new rules would also target active pharmaceutical ingredients (APIs), the key components used in the production of critical medicines. By enhancing the production and procurement of these medicines within the EU and diversifying supply chains, the act seeks to reduce reliance on external suppliers, particularly from regions outside of Europe.
This is especially important for medicines such as antibiotics, which are increasingly in demand due to rising global health challenges. For example, in January 2023 the EMA sounded the alarm about a shortage of amoxicillin in several member states.
A 2021 study by the European Commission warned that the EU is dependent on API imports, noting there is a large regional concentration in the production of generic active pharmaceutical ingredients. It further noted that 80% of imported pharmaceutical ingredients come from only five countries (China, US, UK, Indonesia and India), with China accounting for 45% of the total.
The Council's position on the critical medicines act
On 2 December 2025, the Council agreed its position on the critical medicines act, marking a significant step towards improving Europe's preparedness for health crises. The key points of the Council’s position include:
- information sharing on contingency stocks of medicinal products, improving transparency
- streamlined procurement processes: the minimum number of member states required to submit a joint request for collaborative procurement has been reduced from nine to six, making it easier for countries to work together in securing essential medicines
- resilience over price: in public procurement evaluations, the Council has introduced an obligation for resilience criteria to take precedence over price when purchasing critical medicines. This ensures procurement decisions prioritise security of supply over cost
Next steps
On 12 May, the Council reached a provisional agreement with the European Parliament. The provisional agreement will now have to be endorsed by the Council and the Parliament. It will then formally be adopted by both institutions following legal-linguistic revision.
Last review: 12 May 2026