In recent years, EU Member States have faced serious medicine shortages and global challenges such as the COVID-19 pandemic and geopolitical tensions have exposed vulnerabilities in the pharmaceutical supply chain. Shortages of medicines can put patients’ lives at risk and place a significant burden on healthcare systems. They may arise from reasons including manufacturing issues, supply chain vulnerabilities or global competition for resources.

By combining regulatory tools with targeted industrial policy measures, the CMA strengthens preparedness and supports a more resilient supply of medicines for patients. It builds on the regulatory tools introduced through EMA’s extended mandate and complements the measures in the revised EU pharmaceutical legislation, to reinforce manufacturing capacity and supply resilience for critical medicines. It also aims to improve access to other medicines of common interest which may not be available in certain EU markets, such as medicines…