EBA calls for immunoglobulins to remain on the EU Union List of Critical Medicines

The European Blood Alliance (EBA) has submitted its response to the European Medicines Agency (EMA)’s 2026 review of the Union List of Critical Medicines, urging that intravenous (IVIg) and subcutaneous (SCIg) immunoglobulins remain on the list.

Immunoglobulins are essential plasma-derived medicinal products (PDMPs) used to treat patients with primary and secondary immunodeficiencies and autoimmune diseases. Many patients depend on regular treatment, with no appropriate alternatives available.

EBA warns that removing these medicines from the list could jeopardise patient access, increase supply vulnerabilities and undermine European self-sufficiency. Their production relies entirely on donated human plasma and involves complex processes that typically take 6–12 months. Growing demand, geopolitical uncertainty and dependence on international plasma supplies further increase supply risks.

The response also highlights the importance of the EU’s Substances of Human Origin (SoHO) Regulation (EU) 2024/1938, which promotes increased plasma collection and European self-sufficiency. Several Member States are already investing in public plasma collection programmes.

EBA therefore calls on the EMA and EU policymakers to retain IVIg and SCIg on the Union List of Critical Medicines to safeguard patient access, strengthen supply chain resilience and support Europe’s long-term self-sufficiency in plasma-derived medicinal products.