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

Publisher： Karger

E-ISSN： 1660-3818|33|5|374-383

ISSN： 1660-3796

Source： Transfusion Medicine and Hemotherapy, Vol.33, Iss.5, 2006-09, pp. : 374-383

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Abstract

The European Blood Directive and its implementing CommissionDirectives fill a regulatory gap by providing the first detailedauthoritative European Community legislation to set uniformminimum standards for blood transfusion safety in the EuropeanCommunity. This review will summarize the structureand novelties of the European Directive and focus on the legalbalance of national and European law regarding the implementationin the face of the European subsidiarity principle. The EuropeanBlood Directives determine several new functions anddefinitions, including the responsibilities and qualification ofthe personnel, requirements regarding designation, authorization,accreditation and licensing of blood establishments as wellas the establishment of concrete measures for quality management,and introduce for the first time mandatory multinationalhemovigilance. By setting more detailed standards for the provisionof quality and safety of blood and blood componentswith particular focus on the prevention of the transmission ofviruses, bacteria and parasites, as well as on demands regardingdata protection and confidentiality, the directive goes beyondmost preexisting national standards. However, severalaspects of transmissible pathogen testing or exclusion requirementslack concrete execution requirements. The level of homogeneitywith in Europe will depend on the level of conformityof the countries with the European guidelines, but also on therespective national decisions to exceed the European standards,thus potentially complicating the interchangeability ofblood products and the attempted European self-sufficiency.Continuous implementing activities in the member statesdemonstrate that the European Blood Directive already is onthe road to success.