The Legal Regulation of Access and Benefit-Sharing with Regard to Human Genetic Resources in South Africa

Abstract

Biodiversity legislation in South Africa is weak in terms of the recognition of the customary rights of rural communities vis-a-vis the rights of the State to regulate access and use of the country’s biological resources, including the enforceability of the rights of rural communities and the proper inclusion of prior informed consent. This position is exacerbated by the reality that although benefit-sharing has been established as a principle of international law in the context of biodiversity, a legal framework relevant to benefit-sharing in respect of human genetic resources is lacking. Access to and benefit-sharing for human biological resources (eg blood and DNA-samples) are presently not regulated through a clear international legal framework, such as the Convention on Biological Diversity (CBD) and the recently adopted Nagoya Protocol, both of which only regulate access to plants, animals, micro-organisms and traditional knowledge. In South Africa, access to human genetic resources and benefit-sharing is uncertain in view of the fact that there are presently no national guidelines governing genomic research and its legal or ethical ramifications that succeed in balancing the protection of human genetic information and the promotion of international collaboration that may increase the development of local scientific capacity. Human genetic material may leave South Africa’s borders virtually undetected and undocumented, as has already happened in some instances.