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Unregulated or not? a legal analysis of South Africa’s legislative framework relevant to direct-to-consumer genetic testing.

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Recent advances in science and technology have enabled genetic testing to be conducted inexpensively, expeditiously, and directly by consumers, therefore allowing individuals access to their genetic information without the intervention of healthcare practitioners. This technology can assist individuals to better manage their wellbeing and conserve healthcare funds. Yet, direct-to-consumer genetic testing is not free from controversy primarily due to potential human rights infringements and a perceived lack of regulation. While direct-to-consumer genetic testing may provide consumers with autonomy, involvement in healthcare decisions, convenience, and enhanced genetic literacy, the field remains contentious. The questionable validity, accuracy, and utility of tests, the absence of professional oversight and lack of suitable genetic counselling, potential result misinterpretation, consent processes, follow-up costs which burden healthcare systems, and privacy concerns surrounding the usage and confidentiality of genetic data for research, have brought direct-to-consumer genetic testing to the fore. Despite its growing prevalence, direct-to-consumer genetic testing remains greatly under-investigated in South Africa and, while the need for regulation has been highlighted, it is yet to be fully examined. Therefore, in this dissertation, I map the current legal landscape relating to direct-to-consumer genetic testing in South Africa. This is done through a comprehensive legal analysis of South Africa’s extant law relevant to the industry, and the issues associated therewith – with the intention of determining if, and how, direct-to-consumer genetic testing is legally governed in South Africa and how its various aspects and processes function within the current legislative framework. Through this analysis, I find that the legal landscape in South Africa relating to direct-to- consumer genetic testing is multi-layered and the industry is, in fact, governed by a variety of, sometimes overlapping, statutes and regulations. Clarifying South Africa’s current legal landscape regarding direct-to-consumer genetic testing enables local, as well as foreign, direct-to- consumer genetic testing companies operating in South Africa to better understand the parameters within which they may legally function, in terms of offering genetic tests directly to the public and subsequent genetic research conducted using the genetic data obtained from the samples of consumers.


Masters Degree. University of KwaZulu-Natal, Durban.