EU Reliance on Third-Country Imports of Active Pharmaceutical Ingredients: Obstacles and EU Countermeasures

The European Union’s growing reliance on active pharmaceutical ingredients (APIs) imported from non-EU nations has become a pressing concern for the stability of its pharmaceutical supply networks and the protection of public health. Over the past several decades, much of the API manufacturing for generic drugs has relocated beyond EU borders—mainly to China and India—resulting in a concentration of production risks and increased exposure to global disruptions. Crises such as the COVID-19 pandemic and the war in Ukraine have further highlighted how political and health emergencies can severely hinder access to essential medicines. This paper explores the EU’s current regulatory and policy measures designed to diversify API sources, encourage local manufacturing, and enhance strategic self-sufficiency. It also investigates the underlying factors contributing to drug shortages and the associated threats to healthcare systems and economic stability within the Union. Ultimately, the study emphasizes the importance of a unified, EU-wide strategy to safeguard medicine availability and reinforce the resilience of Europe’s pharmaceutical industry.