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The European Blood Directive and its implementing Commission Directives fill a regulatory gap by providing the first detailed authoritative European Community legislation to set uniform minimum standards for blood transfusion safety in the European Community. This review will summarize the structure and novelties of the European Directive and focus on the legal balance of national and European law regarding the implementation in the face of the European subsidiarity principle. The European Blood Directives determine several new functions and definitions, including the responsibilities and qualification of the personnel, requirements regarding designation, authorization, accreditation and licensing of blood establishments as well as the establishment of concrete measures for quality management, and introduce for the first time mandatory multinational hemovigilance. By setting more detailed standards for the provision of quality and safety of blood and blood components with particular focus on the prevention of the transmission of viruses, bacteria and parasites, as well as on demands regarding data protection and confidentiality, the directive goes beyond most preexisting national standards. However, several aspects of transmissible pathogen testing or exclusion requirements lack concrete execution requirements. The level of homogeneity with in Europe will depend on the level of conformity of the countries with the European guidelines, but also on the respective national decisions to exceed the European standards, thus potentially complicating the interchangeability of blood products and the attempted European self-sufficiency. Continuous implementing activities in the member states demonstrate that the European Blood Directive already is on the road to success.

The European Blood Directive (Directive 2002/98/EC) in the Context of the European Community Legislation