Implementing cross-border transfer of domestic plasma to obtain plasma-derived medicinal products: policy guidance
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World Health Organization
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x, 30 p.
This WHO policy guidance addresses the limited availability of essential plasma-derived medicinal products (PDMPs) in many low- and middle-income countries and examines the role of cross-border transfer of domestically collected plasma as a strategy to improve access to these therapies. The document explains the public health importance of PDMPs for the treatment of hereditary and acquired plasma protein deficiencies and outlines the challenges that hinder their availability, including limited plasma supplies, manufacturing costs, regulatory barriers and insufficient national infrastructure. It describes the rationale for utilizing recovered and source plasma through contract or toll fractionation arrangements with foreign manufacturers when domestic fractionation is not feasible. The guidance analyses ethical, legal, regulatory, economic and operational considerations associated with transferring domestic plasma across national borders for fractionation. It discusses the recognition of donated plasma as a strategic national health resource, measures to protect donor health and safety, and requirements for quality assurance, traceability, haemovigilance and regulatory oversight. The document also reviews barriers encountered by countries seeking to implement such programmes and presents approaches to address them. Based on these considerations, WHO outlines conditions under which cross-border plasma transfer can support equitable, sustainable and affordable access to quality-assured PDMPs while safeguarding donors and strengthening national blood systems.
This WHO policy guidance addresses the limited availability of essential plasma-derived medicinal products (PDMPs) in many low- and middle-income countries and examines the role of cross-border transfer of domestically collected plasma as a strategy to improve access to these therapies. The document explains the public health importance of PDMPs for the treatment of hereditary and acquired plasma protein deficiencies and outlines the challenges that hinder their availability, including limited plasma supplies, manufacturing costs, regulatory barriers and insufficient national infrastructure. It describes the rationale for utilizing recovered and source plasma through contract or toll fractionation arrangements with foreign manufacturers when domestic fractionation is not feasible. The guidance analyses ethical, legal, regulatory, economic and operational considerations associated with transferring domestic plasma across national borders for fractionation. It discusses the recognition of donated plasma as a strategic national health resource, measures to protect donor health and safety, and requirements for quality assurance, traceability, haemovigilance and regulatory oversight. The document also reviews barriers encountered by countries seeking to implement such programmes and presents approaches to address them. Based on these considerations, WHO outlines conditions under which cross-border plasma transfer can support equitable, sustainable and affordable access to quality-assured PDMPs while safeguarding donors and strengthening national blood systems.