Health Security, Critical Medicines and Biomanufacturing
Medicines, APIs, Diagnostics, Vaccines and Bioindustrial Resilience as Strategic European Assets
Europe’s health-security problem is no longer confined to hospitals, reimbursement systems or pharmaceutical demand. It is an industrial-capacity question. The availability of essential medicines, active pharmaceutical ingredients, antibiotics, vaccines, diagnostics and medical devices now depends on regulated production sites, upstream inputs, qualified suppliers, data infrastructures, public procurement mechanisms and emergency manufacturing capacity that can withstand external shocks. The central issue is whether Europe can maintain access to essential health products when global supply chains tighten, external suppliers become unreliable, or demand rises faster than ordinary market mechanisms can respond.
This report examines health security as a strategic-autonomy and industrial-resilience dossier. It first explains why critical medicines and medical countermeasures have become part of Europe’s critical infrastructure problem. It then analyses the EU legal and institutional architecture, including the Critical Medicines Act, HERA, EMA, ECDC, the European Health Data Space, MDR, IVDR, EUDAMED, EudraGMDP, EU FAB and the relevant IPCEI framework. The report then maps the critical value chains behind medicines, APIs, antibiotics, vaccines, diagnostics, medical devices, biomanufacturing, CDMOs, bioreactors, health data and biosurveillance. It concludes by identifying the European companies, production assets, public programmes and enabling infrastructures that materially reduce dependency on external suppliers.