Against the backdrop of ongoing EU-level initiatives to improve the availability of critical medicines and strengthen supply chain resilience, this study aimed to map the overall PDMP policy landscape and key access dimensions, including reimbursement coverage, cost-containment measures, and stockpiling policies across Europe.‍

Plasma-derived medicinal products (PDMPs) are essential therapies made from donated human plasma. These medicines are often life-sustaining for patients with primary and secondary immunodeficiencies and are critical for maintaining functional integrity and quality of life in many rare and debilitating conditions, including dysimmune inflammatory neuropathies, rare bleeding disorders, alpha-1 antitrypsin deficiency, and other serious and rare diseases. Their supply chains differ fundamentally from those of chemically synthesised medicines and other biologics: they depend on a scarce biological starting material (donated human plasma), a long and highly regulated manufacturing (fractionation and purification) pathway, and a very limited ability to rapidly scale production . The fragility of the supply chain is further compounded by the EU’s structural dependence on plasmaimported from the United States, which accounts for approximately 38% of all plasma used for the manufacturing of PDMPs in Europe.