Critical Medicines Act: analysis of the challenges and the path to health and pharmaceutical sustainability

This study represents a desk-based research analysis aimed at examining the European Commission’s draft regulation—the Critical Medicines Act (CMA)—designed to strengthen the availability and security of supply of critical medicinal products within the European Union (EU). Through a systematic review of legislative documents, strategic reports, official statements, and scientific publications, the study identifies the main objectives, instruments, and potential weaknesses of the proposed framework. The analysis emphasizes the need to balance European strategic autonomy with the national sovereignty of Member States in the field of healthcare. The results indicate that, despite the CMA’s significant potential to enhance pharmaceutical security, challenges related to administrative burden, EU-level coordination, and the feasibility of implementation timelines remain substantial. The study concludes with recommendations for optimizing implementation and reducing bureaucratic and logistical barriers.