The European Union‘s dependence on imports of active pharmaceutical ingredients from third countries – challenges and EU initiatives

The European Union’s dependence on imports of active pharmaceutical ingredients (API) from third countries has emerged as a critical challenge to the resilience of pharmaceutical supply chains and public health. Over recent decades, the production of API for generic medicines has progressively shifted outside the EU, primarily to China and India, leading to risk concentration and heightened vulnerability during global disruptions. The COVID-19 pandemic and the war in Ukraine further exacerbated the problem, illustrating how geopolitical and health crises can interrupt access to essential medicinal products. This study examines the existing regulatory frameworks and policy initiatives of the European Union aimed at diversifying supply sources, promoting domestic production, and strengthening strategic autonomy. It identifies the root causes of medicine shortages as well as potential risks to the Union’s health systems and economic security. The article underscores the need for a comprehensive and coordinated EU-level approach to ensure the security of medicine supply and to achieve greater resilience in the European pharmaceutical sector.