Réglementation européenne relative au sang et à ses composants : déclinaison au niveau de la réglementation française

Abstract

The European regulation on blood and blood components is declined in four directives: the Directive 2002/98/EC known as “mother Directive” and three directives called “daughter Directives” 2004/33/EC, 2005/61/EC and 2005/62/EC. It constitutes a common basis of provisions of quality and safety of blood in the European Union (EU), thus guaranteeing this safety and this quality with the whole of the citizens circulating in Member States of the Union. It cannot prevent a Member State for maintaining or introducing more stringent protective measures. It encourages the anonymous, voluntary and unpaid blood donations. It envisages many provisions for the prospective blood donor eligibility, the blood collection, the testing, processing, storage, transport, distribution and issuing of blood and blood components and the haemovigilance. In the field of the haemovigilance, this European regulation widened the field of competence of the national systems to the notification of serious adverse events of the transfusion chain and the serious adverse reactions, which have occurred in the blood donors. The European directives were transposed in the French national law between 2004 and 2007 by legislative and lawful ways.