RESUMO
There is no legislation specifically designed to compensate haemophilia patients who have been damaged by defective blood products. But there is a general regime, created as a result of the thalidomide tragedy, which deals with defective 'products'. It was introduced at the European level by the European Directive on Product Liability in 1985 and has been given effect in England by the Consumer Protection Act 1987. The rights of haemophilia patients who are injured by defective blood products depends on this Directive.
Assuntos
Proteínas Sanguíneas/provisão & distribuição , Ética Médica , Legislação Médica , Proteínas Sanguíneas/efeitos adversos , Proteínas Sanguíneas/economia , Criança , Infecções por HIV/prevenção & controle , Infecções por HIV/transmissão , Hemofilia A/terapia , Humanos , Doença Iatrogênica , Jurisprudência , Masculino , Risco , Segurança , Terapêutica/economiaRESUMO
Manufacturers of blood products have to maintain the highest possible standards for plasma screening and good manufacturing practices to ensure maximum purity and viral safety. The private sector companies have much experience in implementing and complying with national and international regulations. These requirements involve considerable cost in the areas of (1) plasma collection facilities, (2) research and clinical research, (3) manufacture, and (4) quality control. Total self-sufficiency would mean the loss of many existing resources. An alternative would be a collaboration between the public and private sectors to meet the needs of all patients who require plasma derived products. The current definition of self-sufficiency suggests that it is not financially viable.
Assuntos
Proteínas Sanguíneas/provisão & distribuição , Bancos de Sangue/economia , Bancos de Sangue/normas , Proteínas Sanguíneas/efeitos adversos , Proteínas Sanguíneas/economia , Comércio , Europa (Continente) , Financiamento Governamental , Organização do Financiamento , Custos de Cuidados de Saúde , Humanos , Plasma , Controle de Qualidade , Apoio à Pesquisa como Assunto , SegurançaRESUMO
The ultimate responsibility for selecting and administering plasma products to patients rests with the prescribing physician, and it is for him/her to choose the safest product available. However, liability for a product with a full licence rests exclusively with the licence holder. After the problems of HIV and hepatitis C the safety of plasma-derived products has become of paramount importance. Particularly in the public sector, financial, strategic and political obstacles may adversely influence the quantity, quality and safety of plasma collection. The safety of blood products can be substantially enhanced by the harmonization of technical standards across both public and private sectors, thus supporting EC Directive 89/381. Additionally, the goal of European rather than national self-sufficiency should be encouraged.