Who would own the HeLa cell line in South Africa?

June 8, 2023June 8, 2023 ~ Donrich Thaldar

The HeLa cell line was created in 1951 from a biopsy sample removed from a cancer patient, Henrietta Lacks, at Johns Hopkins Hospital in the United States. Over the past 70 years, the HeLa cell line was used in countless health-related innovations, ranging from the polio vaccine in the 1950s to studying the human genome, and more recently the COVID-19 vaccines. The problem, however, is that Henrietta Lacks’ consent was never obtained to use the biopsy sample for research purposes. Although the actions that took place were accepted practice 70 years ago, society’s values have since changed. As such, the HeLa cell line has become controversial. In 2021, the descendants of Henrietta Lacks sued a well-known biotechnology company for the profits it made from the HeLa cell line. Who owns the HeLa cell line? What would be the legal position if this happened in South Africa? In this article in the Journal of the Law and Biosciences, I answer this question.

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

September 19, 2022September 19, 2022 ~ Donrich Thaldar

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.

If fertility patients pass away, what happens to their in vitro embryos?

September 2, 2022September 2, 2022 ~ Donrich Thaldar

South African fertility clinics often include a provision in their consent forms that deals with the disposition of reproductive material (gametes and embryos) after a fertility patient’s death. This practice is problematic as such a provision is not legally valid. If the clinic acts in pursuance of such a provision upon a fertility patient’s death, the fertility clinic may be committing a civil wrong and a crime. But what is the solution? Read more in my article in the South African Medical Journal.

The legal status of human biological material used for research

December 8, 2021December 29, 2021 ~ Donrich Thaldar

Whether human biological material (‘HBM’) in the research context is susceptible of ownership in South African law is contested, yet under-investigated. Previous literature on the subject barely touches the surface, and fails to provide in-depth, comprehensive legal analyses. This situation leads to legal uncertainty for local scientists, their international collaborators, and research ethics committees. In our latest article, published in South Africa’s most prestigious peer-reviewed law journal, Dr Bonginkosi Shozi and I dive deep into this topic — analysing both common law and statutory law — and conclude that HBM in the research context is indeed susceptible of ownership. We also consider the question of who owns HBM in various practical research-related scenarios. Importantly, we conclude that in all legally compliant scenarios HBM is owned by a research institution. There is no legally compliant scenario in which research participants can retain ownership of the HBM that they provide for research. We trust that our thorough analysis in this article will provide much-needed legal certainty to all involved in using HBM for research in South Africa.