RESUMO
The regulation of cell therapy and gene therapy products is a major challenge for the Brazilian state. From a legal point of view, the legislative apparatus, including constitutional, prohibits the marketing and patent of human substances. From the point of view of the organization of the state bureaucracy, the responsibilities for the regulation of research and application of these technologies in humans may involve up to four different institutions. The National Agency for Health Surveillance (ANVISA) has been the protagonist in structuring the regulation of cell therapy and gene therapy in Brazil, and steps have been taken to ensure quality of these products. However, obstacles such as the commercialization of these therapies and the need to determine whether these products will be regulated following the assumptions adopted in Brazil for drugs and biological products or for human blood and tissues still remain.
Assuntos
Terapia Baseada em Transplante de Células e Tecidos/ética , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Terapia Genética/legislação & jurisprudência , Animais , Brasil , Terapia Baseada em Transplante de Células e Tecidos/métodos , Ensaios Clínicos como Assunto , Avaliação Pré-Clínica de Medicamentos , Terapia Genética/ética , Humanos , Segurança do Paciente/legislação & jurisprudência , Guias de Prática Clínica como Assunto , Controle de QualidadeRESUMO
Las investigaciones con células madre representan un desarrollo de vanguardia en la investigación biomédica que puede ofrecer un medio eficaz para tratar enfermedades que actualmente tienen pocas o ninguna opción de tratamiento. Estos avances han generado nuevas áreas para la investigación tanto a nivel académico como industrial y han planteado nuevos desafíos para la actual regulación de productuos terapéuticos. En el ámbio ético-jurídico, la investigación con células madre plantea dos grandes campos de problemas: los derivados de su obtención y los inherentes a su utilización. El marco normativo creado para regular una y otra problemática se ha efectuado por separado en la mayoría de las legislaciones nacionales, dado que comprometen decisiones normativas de diferente jerarquía. Identificaremos las principales cuestiones, tendencias y soluciones normativas que se plan teas a partir de estas nuevas tecnologías...
Assuntos
Humanos , Pesquisa com Células-Tronco/legislação & jurisprudência , Terapia Biológica/ética , Terapia Biológica/normas , Terapia Baseada em Transplante de Células e Tecidos/ética , Terapia Baseada em Transplante de Células e Tecidos/normasRESUMO
Argentina has a significant number of researchers in public and private institutions conducting research in regenerative medicine and stem cells. There is not specific legislation in this area; however, the National Ministry of Health has issued regulations under the scope of the Transplant Act and the Medicines Act. Alongside the groups doing research, it is possible to find professionals offering experimental stem cell therapies to patients. These professionals take refuge in the term "medical practice" and sell experimental treatment to patients with no guarantee of safety and security given that they were not tested in clinical research. These practices offered to patients in a scheme, apparently legal, are generating an important number of judicial actions requesting the payment of said treatments. The decisions of the courts ordering payment in most cases are generating a transfer of funds from patients, social welfare systems, and the state to medical centers offering stem cell experimental therapies. This article describes the current regulations as well as the course of action to solve the emerging problems of these new technologies at legislative level.