“No!” to a moratorium on heritable human genome editing research

~ Donrich Thaldar

While TB and HIV are not a public health concern in many other nations, these diseases remain epidemics in South Africa. Clearly, people in South Africa have good reason for wanting to ensure that their children are not afflicted by these diseases. Heritable human genome editing (HHGE) could potentially offer a solution, but only if research in this area is allowed to proceed. This is why calls for a global moratorium on HHGE research is misaligned with the needs and expectations of South Africans, and raise concerns about ethical imperialism. A better approach to HHGE research is to encourage it within a clear regulatory framework. Read the full argument here.

Photo 4720616 / Dna © Lush | Dreamstime.com

The legal status of human biological material used for research

~ 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.

Photo 73345087 / Blood Sample © Angellodeco | Dreamstime.com

The Constitutional Court rules on foetal burial

~ Donrich Thaldar

Pregnancy loss can be emotionally traumatic to expecting mothers and fathers. If we are a compassionate society, should we not allow these bereaved parents to bury or cremate the foetal remains, if they so wish? I served as legal counsel for a non-profit organisation, Voice of the Unborn Baby, in a court application that aims to change the law to recognise the right of parents who suffer pregnancy loss to bury or cremate the foetal remains, if they so wish.

The case was heard by the Constitutional Court on 4 November 2021. Here are links to video recordings of my opening argument (about 10 minutes) and closing argument (about 2 minutes).

You can also read my heads of argument and my supplementary heads of argument.

On 15 June 2022, the Constitutional Court handed down its judgment. It held that the relevant national statute that regulates burial should be interpreted to exclude pre-viable foetuses. This means that – contrary to this statute’s interpretation in practice – burial of pre-viable foetuses is not prohibited. Although the Constitutional Court stopped short of recognising the right of parents who suffer pregnancy loss to bury or cremate the foetal remains, its judgment effectively clears the path for such parents in practice to bury or cremate the foetal remains.

Grantsmanship in action

~ Donrich Thaldar

In September 2021, a research project application that I conceptualised and drafted was awarded R18 million in funding by the US National Institutes of Health (NIH). The NIH is the world’s largest public funder of health-related research, supporting research worldwide that has an impact on knowledge of health and medicine. 

The project will focus on the legal aspects of the use of data science for health innovation in Africa. It aims to provide legal clarity and practical guidance on issues that are critical for scientists. These issues include, inter alia, the processing of persons’ geospatial data, the cross-border sharing of data, and the use of data to train artificial intelligence. 

The project will also make recommendations on inter-jurisdiction harmonisation through the lens of Africanisation. It will involve 12 African nations and will be driven by a project team of leading law academics from different regions on the continent. As principal investigator, I will be responsible to coordinate between all the consortium partners and researchers involved. 

*The content of this is article does not necessarily represent the official views of the NIH.

Here is a link to the announcement by my University.

AI inventorship: A world-first for South Africa

~ Donrich Thaldar

In July 2021 South Africa became the first jurisdiction in the world to grant a patent where the inventor is not human, but an artificial intelligence (AI). My doctoral student, Meshandren Naidoo, and I wrote an article on this historic world-first for South Africa.

The AI creativity machine in question, called DABUS, which was made by American entrepreneur Dr Stephen Thaler, invented a new food container. Thaler applied for a patent on this invention in various jurisdictions around the world. During 2020, Thaler’s patent applications were refused by the by European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO). These patent offices followed a strictly textual approach in interpreting their respective patent legislation – thereby excluding AI from the definition of ‘inventor’. In this light, the decision by the South African Companies and Intellectual Property Commission (CIPC) to grant a patent for the same application that was refused by two of the world’s leading patent offices came as a surprise to many. In our article, we investigate whether the South African decision was legally correct. Our analysis is informed by the ground-breaking judgment by the Australian Federal Court on DABUS’s food container patent application. This judgment was handed down just a few days after the South African decision was published and provides sound legal rationales in support of allowing AI inventorship. Importantly, the Australian Federal Court adopted a purposive approach to interpreting patent legislation – in contrast with the EPO and USPTO. Since South African law adheres to a purpose approach, the Australian judgment offers a more suitable precedent to follow. It is concluded that the South African CIPC decision was legally correct. Furthermore, it is clarified that allowing AI inventorship does not necessarily imply that AI has legal personhood. 

Read the full article here.