Implementing cross-border transfer of domestic plasma to obtain plasma-derived medicinal products: policy guidance

Preface

Based on various concerns, governmental authorities in low- and middle-income countries, as well as in some highincome countries, often ban exportation of domestic human plasma, or do not have in place regulations and legislation to guide the export of plasma However, the World Health Organization (WHO) regards transfer of domestic plasma across borders, when linked to provision in return of industrially manufactured plasma-derived medicinal products (PDMPs), as a compelling national interest This is especially so in settings where access to essential PDMPs is inadequate to meet patient needs This document was developed to inform ministries of health about the WHO policy as part of a programme to improve global access to essential PDMPs It discusses the existing barriers to exportation of plasma and provides the rationale for policy decisions in favour of foreign processing (“fractionation”) of domestic plasma to improve availability and affordability of PDMPs It also recommends measures for overcoming barriers to cross-border transfer of domestic plasma, which is defined as shipment of domestic plasma to a manufacturer in a foreign country under an arrangement for “contract” or “toll” fractionation.