Article Abstract

The organization of transfusion and fractionation in France and its regulation

Authors: Françoise Rossi

Abstract

Transfusion and plasma fractionation in France are closely linked to the historical reliance on voluntary unpaid blood donation that constitutes the foundation in the national system for the supply of labile blood components and stable fractionated plasma products. From 1993, three successive laws on safety of blood and medicines have been implemented to separate the missions of the stakeholders leading to clearly distinguish the mission of producers and regulatory bodies: operator for the blood sector, Établissement Français du Sang (EFS), operator for the fractionation into medicines, Laboratoire français du Fractionnement et des Biotechnologies (LFB), and the regulator, the French National Agency for the Safety of Medicines and Health Products (ANSM). LFB has received the mandate of manufacturing fractionated plasma products from the plasma collected by EFS and to serve as a priority the needs of French patients. Since 1989, the European Union has built the regulatory framework for stable products, which are considered as medicinal products derived from human blood or human plasma. Many European legal and regulatory organisations supervise quality, biological safety, clinical safety, and efficacy of both blood components and medicinal products derived from human plasma. Guidelines, monographs, good practices (GXP or blood good practices) and others regulatory documents prompt operators to comply with these requirements, whereas operators, by improving their manufacturing practices, lead the regulation to adapt to innovation. France addresses these requirements in many legal and regulatory texts, most transposed from European legislation. While the two sectors are regulated in France by one unique national competent authority, the European Medicines Agency (EMA) does not include blood and blood components regulation under its responsibility. The safety and protection of donors is still carried out by the collegial cooperation of European and international operators. The European Commission has started to reflect on substances for human origin regulations as a whole, and a revision of the blood directive might lead to adapted definitions of voluntary, non-remunerated blood donations [including for plasma for fractionation (PfF)] in order to further protect the human body and its parts and to promote appropriate supply of European plasma.