RESUMO
For the most part, the law of the European Community (EC) is specified in directives. This also applies to the field of medicinal products, medical devices, blood and tissue preparations. As a rule, the provisions stipulated in the EC directives shall not enter into force before they have been implemented into national law in the Member States of the European Union (EU). The implementation is mandatory and makes Community Law binding in the EU Member States. Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (EC Tissues and Cells Directive) was finally implemented into German law when the Tissues Act of 20 July 2007 entered into force. Due to the special features of this directive, the national legislators may stipulate stricter provisions, thus exceeding the minimum standards specified in this EC directive. The national legislators are free to choose the legal instrument for the legally binding transposition of EC law. In Germany, the requirements set forth in the EC Tissues and Cells Directive have been implemented within the national legal framework, especially by virtue of the Medicinal Products Act, the Transplantation Act and the Transfusion Act.
Assuntos
Indústria Farmacêutica/legislação & jurisprudência , Equipamentos e Provisões/normas , União Europeia/organização & administração , Marketing/organização & administração , Vigilância de Produtos Comercializados/normas , Bancos de Tecidos/legislação & jurisprudência , Europa (Continente)RESUMO
Variant Creutzfeldt-Jakob disease (vCJD) is an at present inevitably lethal neurodegenerative disease which can only be diagnosed definitely post mortem. The majority of the approximately 200 victims to date have resided in the UK where most contaminated beef materials entered the food chain. Three cases in the UK demonstrated that vCJD can be transmitted by blood transfusion. Since BSE and vCJD have spread to several countries outside the UK, it appears advisable that specific risk assessments be carried out in different countries and geographic areas. This review explains the approach adopted by Germany in assessing the risk and considering precautionary measures. A fundamental premise is that the feeding chain of cattle and the food chain have been successfully and permanently cleared from contaminated material. This raises the question of whether transmissions via blood transfusions could have the potential to perpetuate vCJD in mankind. A model calculation based on actual population data showed, however, that this would not be the case. Moreover, an exclusion of transfusion recipients from blood donation would add very little to the safety of blood transfusions, but would have a considerable impact on blood supply. Therefore, an exclusion of transfusion recipients was not recommended in Germany.