The Regulatory Pathway for Advanced Cell Therapy and Gene Therapy Products in Brazil: A Road to Be Built.

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.

Indigenous self-determination in an age of genetic patenting: recognizing an emerging human rights norm.

This Note explores how the law can help indigenous people obtain meaningful control of their genetic material. Part I will briefly discuss the background of genetics, life patents, and indigenous groups. Part II sets out the domestic common law and international human rights law and demonstrates that neither currently provide adequate protection for indigenous peoples. Part III considers the human right of self-determination in the context of indigenous research and patenting, and illustrates that an emerging international norm recognizes an indigenous people's right to control their genetic material. Part IV argues that Congress should pass legislation to adequately meet the human rights needs of indigenous peoples generated by the rapid advancement of biotechnology. This Note concludes that congressional action to protect indigenous peoples is consistent with domestic and international law, and is a natural advancement of human rights and responsible state action.