Direct-to-consumer genetic testing: Is it lawful in South Africa to take your own buccal swab?

Despite the growing popularity of direct-to-consumer genetic testing, there is not a lot of literature on the topic in South Africa. The limited available research suggests that direct-to-consumer genetic testing is unregulated. However, Amy Gooden and I have investigated this topic and found 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. But this is only the beginning of our legal analysis, not the end! Read more here.