Direct-to-Consumer Genetic Testing in South Africa: Stumbling Over the First Legal Hurdle?

Despite the growing popularity of direct-to-consumer genetic testing, there is minimal South African literature on the topic. The limited available research suggests that direct-to-consumer genetic testing is unregulated. However, we suggest that direct-to-consumer genetic testing is indeed regulated, and unusually so. The first step in the process - the collection of a saliva sample by consumers themselves - is unlawful on a plain reading of the National Health Act 61 of 2003 and the Regulations Relating to the Use of Human Biological Material. This is because these statutes require that certain healthcare professionals must remove saliva for genetic testing. Yet, on closer analysis, such an apparent ban on the self-collection of saliva is neither aligned with a purposive interpretation of the relevant legislation, nor would it survive constitutional scrutiny - as it impedes an individual's autonomy. It is concluded that, contrary to a plain reading of the relevant statutes, individuals can lawfully collect their own saliva for direct-to-consumer genetic testing. To provide legal clarity we recommend that the relevant provisions of the National Health Act 61 of 2003 and Regulations Relating to the Use of Human Biological the Material be amended to allow individuals to collect their own saliva samples.