The challenge of manufacturing critical medicines in the EU

Over recent decades, freer trade and international specialisation have progressively concentrated pharmaceutical production, particularly for generic medicines, in a limited number of countries, especially China. As a result, excessive dependence on imported medicines has become a major vulnerability for the EU amid geopolitical tensions and the weaponisation of trade. In response, the EU has proposed the Critical Medicines Act, which seeks to strengthen supply security through trade strategies (such as supplier diversification) and by reinforcing domestic manufacturing capacity. Focusing on selected active pharmaceutical ingredients—the key inputs in medicines—included in the Union List of Critical Medicines, this article examines the complexity of pharmaceutical supply chains and the structural challenges affecting reshoring strategies. The article concludes by arguing that the EU should be highly selective in identifying which domestic production capacities to promote, not only to ensure the availability of essential medicines when imports become unreliable, but also to improve its bargaining power vis-à-vis foreign suppliers during geopolitical crises that may culminate in export restrictions.