The European Commission proposes new rules to ensure stable supply of critical medicines

The European Commission has proposed a Regulation to improve the availability of critical medicines in the EU. The proposal aims to protect human health by incentivising supply chain diversification and boosting pharmaceutical manufacturing in the EU. This will support the EU's pharmaceutical sector which is a major contributor to our economy. The Act also aims to improve access to other medicines of common interest, which may not be available in certain markets. This initiative contributes to the European Health Union's goal of ensuring that EU patients have access to the medicines they need, when they need them.

President von der Leyen announced the Critical Medicines Act in her political guidelines to reduce dependencies and enhance the EU's resilience, particularly for medicines and active ingredients where there are only few supplying manufacturers or countries. It complements legislative proposals already put forward to address medicine shortages in the EU, notably the pharmaceutical reform.

In recent years, Member States have been confronted with serious medicine shortages and global challenges such as the COVID-19 pandemic and geopolitical tensions clearly exposed significant vulnerabilities in the EU's pharmaceutical supply chain. Shortages can put patients' lives at risk and place a significant burden on our healthcare systems. These shortages can be caused by manufacturing problems, supply chain vulnerabilities or global competition for resources. The Critical Medicines Act aims to provide an industrial toolkit to address these problems, by making the EU a market in which producing critical medicines will be more attractive.