Unregulated or not? a legal analysis of South Africa’s legislative framework relevant to direct-to-consumer genetic testing.
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Date
2021
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Abstract
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.
Description
Masters Degree. University of KwaZulu-Natal, Durban.