CPMP Position Statement: Non-Remunerated and Remunerated Donors Safety and Supply of Plasma Derived Medicinal Products

摘要

During the recent Co-Decision Procedure regarding the proposed Blood Directive, the European Parliament has raised the question of whether the use of non-remunerated donors is important for assuring the overall safety of plasma-derived medicinal products.The safety of plasma-derived medicinal products is optimised by the stepwise application, in the course of the collection, manufacture and batch release testing, of a number of complementary measures, which are under regulatory control. Both non-remunerated and remunerated donors contribute to the supply with safe plasma-derived medicinal products. Since a very substantial proportion of the total amount of plasma-derived medicinal products used in Europe originate from remunerated donors, a requirement for non-remunerated donors would create major supply problems.The question of whether or not non-remuneration is important for the safety of blood and blood components for transfusion is a separate issue outside the scope of this document.