Guidance on increasing supplies of plasma-derived medicinal products in low- and middle-income countries through fractionation of domestic plasma

Overview

Several plasma-derived medicinal products (PDMPs) are included in the WHO Model List of Essential Medicines, highlighting them as medications considered to be the most effective and safe to address the major needs in a health system. However, PDMPs are in shortage at global level, most severely affecting patients in LMIC. Inadequacy of PDMPs in those countries also results from an insufficient domestic supply of plasma of a quality suitable for non-domestic fractionation and from a lack of technical and financial capacity to implement a domestic plasma fractionation programme.

Supporting access to quality and safe PDMPs at global level aligns with the objectives of World Health Assembly (WHA) resolution 63.12 (2010) on availability, safety and quality of blood products, addressing a major unmet public health need that has steadily increased with expanded use of these medically important products.  This white paper was developed within the scope of the World Health Organization (WHO) Action Framework to Advance Universal Access to Safe, Effective and Quality-Assured Blood Products 2020–2023, consistent with WHA resolutions and WHO documents that are relevant to global advancement of blood systems.  It is intended to provide a high-level overview and recommendations for actions that can be taken by policy-makers, national regulatory authorities, blood collection organizations, blood donors and their associations, clinicians and patients as a roadmap toward reducing wastage of plasma that could be fractionated to make the PDMPs and thus increase access to PDMPs in low- and middle-income countries (LMIC).  The document highlights the steps that can be taken to increase the production of quality and safe plasma from voluntary non-remunerated donors in LMIC and to enable its use in fractionation.