Health Law

In this podcast, Professor Thaldar interviews Mr Paul Esselaar, Ms Devarasi Bellengère, and Mr Banele Mhlongo on the topic of the NHREC’s draft revised MTA.

Summary

The South African National Health Research Ethics Council (NHREC) has issued a revised draft of the 2018 material transfer agreement (MTA), prompting discussions on its mandate, treatment of data and biological material, and avoidance of ownership terminology. With the activation of the Protection of Personal Information Act (POPIA) in 2021, doubts arise regarding NHREC's authority over personal information in health research. The draft MTA's approach to data is criticized as superficial, and its handling of human biological material overlooks legal and ethical concerns related to pathogens. The use of "steward" instead of "owner" in the MTA clashes with South African law and neglects ethical arguments for ownership recognition. Recommendations for the MTA's improvement include making its adoption optional, separating data transfer agreements, addressing liability for pathogen-containing materials, and adopting a decolonial framework that acknowledges the ownership rights of local research institutions to support bio-economy growth.

Further reading

Esselaar P, Swales L, Bellengère D, Mhlongo B, Thaldar DW. Forcing a square into a circle: why South Africa’s draft revised material transfer agreement is not fit for purpose. Frontiers in Pharmacology. 2024.

See also

Swales L, Ogendi P, Botes M, Townsend B, Donnelly D-L, Abdulrauf L, Thaldar DW. A data transfer agreement template for South Africa (2023).

Swales L, Botes M, Donnelly D-L, Thaldar DW. Towards a data transfer agreement for the South African research community: The empowerment approach. South African Journal of Bioethics and Law. 2023;16(1):13–18.

Thaldar DW, Botes M, Nienaber A. South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation. BMC Medical Ethics 2020;21(85):1-13.

Thaldar DW. One material transfer agreement to rule them all? A call for revising South Africa’s new standard material transfer agreement. Humanities and Social Sciences Communications 2020;7(105)

In this podcast episode, Ms Nomfundo Mthembu and Ms Amy Gooden discuss the ethical considerations in establishing an open access genomics database in South Africa.

Summary

Although genomics research has the potential to improve healthcare, only a small percentage of genomic data used internationally relates to persons of African origin. Although the establishment of a large scale, open access genomics database of South Africans may contribute to solving this problem, it is not without its ethics concerns, such as privacy risks and informed consent. Open consent offers a potential solution by being explicit about the risks involved. Furthermore, in the South African context—where local culture is infused with Ubuntu—community engagement is vital for establishing and maintaining an open access genomics database of South Africans.

Further reading

Gooden, A., and Thaldar, D. (2023). Toward an open access genomics database of South Africans: Ethical considerations. Frontiers in Genetics.

Thaldar D, Gooden A and Steytler M (2023) Open science and human genetic data: recommendations on South Africa’s Draft National Open Science Policy. Frontiers in Genetics.

See also

Thaldar, D., Gooden, A., and Donnelly, D.-L. (2023). Toward an open access genomics database of South Africans: Legal considerations. South African Journal of Science.

In a podcast, Professor Mnyongani interviews Dr. Swales and Dr. Donnelly, who developed a Data Transfer Agreement (DTA) template for the South African research community.

Summary

The DTA template helps ensure legal compliance, notably with the Protection of Personal Information Act (POPIA). It aids researchers by providing a standardized, flexible legal document, saving time and reducing costs. Unlike the regulatory approach of the 2018 Material Transfer Agreement by the Health Ministry, their ‘empowerment approach’ equips researchers with tools and knowledge without mandating usage. The DTA emphasizes clear data ownership and adaptability for commercial purposes, ensuring legality and ethical considerations. With upcoming regulations like ASSAf's Code of Conduct for Research, the DTA aligns and complements these frameworks. For international collaborations, the template addresses data transfers between South Africa and foreign entities, aligned with POPIA. The goal is a comprehensive, adaptable, and empowering tool that considers various scenarios in research data transfer.

Further reading

Swales L, Ogendi P, Botes M, Townsend B, Donnelly D-L, Abdulrauf L, Thaldar DW. A data transfer agreement template for South Africa (2023).

Swales L, BotesM, Donnelly D-L, Thaldar DW. Towards a data transfer agreement for the South African research community: The empowerment approach. South African Journal of Bioethics and Law. 2023;16(1):13–18.

See also

Thaldar DW, Botes M, Nienaber A. South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation.BMC Medical Ethics2020;21(85):1-13.

Thaldar DW. One material transfer agreement to rule them all? A call for revising South Africa’s new standard material transfer agreement. Humanities and Social Sciences Communications 2020;7(105)

Funding

This episode was made possible by a grant from the U.S. National Institute of Mental Health and the U.S. National Institutes of Health (award number U01MH127690) under the Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) program. The content of this podcast is solely the responsibility of discussants of the podcast and does not necessarily represent the official views of the U.S. National Institute of Mental Health or the U.S. National Institutes of Health.

In this podcast episode, Nomfundo Mthembu discusses the ownership of the HeLa cell line with Professor Donrich Thaldar.

Summary

The HeLa cell line was created in 1951 without consent from Henrietta Lacks, the person whose tissue sample was used. Ownership of cell lines is investigated from a South African legal perspective by considering three possible contemporary scenarios bearing points of similarity to the Henrietta Lacks case. The importance of legal compliance and good faith is highlighted.

Further reading

Thaldar DW. Who would own the HeLa cell line if the Henrietta Lacks case happened in present-day South Africa? Journal of Law and the Biosciences. 2023.

See also

Thaldar DW, Shozi B. The legal status of human biological material used for research. South African Law Journal. 2021.

Funding

This episode was made possible by a grant from the U.S. National Institute of Mental Health and the U.S. National Institutes of Health (award number U01MH127690) under the Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) program. The content of this podcast is solely the responsibility of discussants of the podcast and does not necessarily represent the official views of the U.S. National Institute of Mental Health or the U.S. National Institutes of Health.

In this podcast episode, Professor Donrich Thaldar and Dr Faith Kabatadiscuss the governance of human genomic data in Africa.

Summary

Genomic sovereignty has no utility value in human genomic research as it violates the rights of individuals and researchers. Mexico’s regulatory approach that is based on genomic sovereignty is contrasted with Finland’s more individual-centric, human rightsapproach. It is suggested that this human rights approach is more promising, as it aligns with states’ obligations under international human rights law—in particular the right to science.

Further reading

Kabata F, Thaldar DW. Regulating human genomic research in Africa: Why a human rights approach is a more promising conceptual framework than genomic sovereignty. Frontiers in Genetics2023;14.

Funding

This episode was made possible by a grant from the U.S. National Institute of Mental Health and the U.S. National Institutes of Health (award number U01MH127690) under the Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) program. The content of this podcast is solely the responsibility of discussants of the podcast and does not necessarily represent the official views of the U.S. National Institute of Mental Health or the U.S. National Institutes of Health.

In this episode, we speak about the res nullius construction of human genomic data.

Summary

No one domain of the law holds exclusive sway over human genomic data. Instead, genomic data have a multidimensional legal nature, meaning that multiple legal domains — including property law, privacy law, contract law, and intellectual property law — are all applicable. From a property law perspective, the res nullius construction of genomic data provides a useful way to understand how newly generated genomic sequences are viewed by the law.

Further reading

Thaldar et al. The multidimensional legal nature of personal genomic sequence data: A South African perspective. Frontiers in Genetics.(2022).

Funding

This episode was made possible by a grant from the U.S. National Institute of Mental Health and the U.S. National Institutes of Health (award number U01MH127690) under the Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) program. The content of this podcast is solely the responsibility of discussants of the podcast and does not necessarily represent the official views of the U.S. National Institute of Mental Health or the U.S. National Institutes of Health.

In this podcast, Professor Donrich Thaldar and Ms Aliki Edgcumbe discuss the genetic-link requirement for surrogate motherhood agreements.

Summary

What do Kim Kardashian, Elon Musk, and Elton John have in common? Well, it is not just their mega success as celebrities. These stars share something far more interesting – they are just some of the rich and famous who have used a surrogate to have their children.

But, the surrogacy stories are not limited to the gossip columns in your local tattler. The ones less told are the stories of ordinary infertile couples (and individuals) who look to surrogacy to build a family they would otherwise be unable to have.

Professor Donrich Thaldar is joined by Ms Aliki Edgcumbe, a doctoral research fellow at the University of KwaZulu-Natal. She has written an article on the current case, that of KB v Minister of Social Development, where she asks whether the writing is on the wall for the genetic link requirement in surrogacy agreements.

Further reading

Edgcumbe, A. (2023). Is the Writing on the Wall for the Genetic Link Requirement in Surrogacy Agreements?. Potchefstroom Electronic Law Journal, 26, (Published on 3 March 2023) pp 1 – 26.

https://doi.org/10.17159/1727-3781/2023/v26i0a13363

In this podcast episode, Professor Donrich Thaldar and Ms Michaela Steytler discuss the right to freedom of scientific research.

Summary

Despite the fact that the Constitution explicitly protects the right to freedom of scientific research, this right features neither in the preamble of any legislation, nor in any reported case law. If the right to freedom of scientific research remains in obscurity, South Africa can slip into totalitarian control of the scientific enterprise – to the detriment not only of scientists, but also of society in general. The right to freedom of scientific research should play a more central role in policy-making. This is not only because it is an enumerated constitutional right, but also because it is important in its own right, as it serves purposes that are at the core of our constitutional value-system: promoting individual autonomy, facilitating the search for truth, and supporting democracy. The notion that government should somehow seek to regulate every new scientific development is erroneous, as freedom should be the default position in science-related policy, and should only be limited by regulation if and to the extent that it is constitutionally justified.

Further reading

Thaldar DW, Steytler M. Time for Cinderella to go to the ball: Reflections on the right to freedom of scientific research. South African Law Journal. 2021.

In this episode, Professor Donrich Thaldar explains the multidimensional legal nature of personal genomic sequence data.

Summary

There are multiple legal dimensions applicable to personal genomic sequence data. These include (1) property rights, (2) personality rights, and (3) intellectual property rights. (1) Personal genomic sequence data can be owned. The entity that is in the best position to claim ownership of personal genomic sequence data is the research institution that generates such data, i.e., the research institution that does the sequencing of the DNA. However, the ownership of personal genomic sequence data can also be provided for through contract. (2) Personal genomic sequence data are the object of data subjects’ personality rights, which includes privacy rights. (3) Personal genomic sequence data are also the object of intellectual property rights. The interplay between legal dimensions (1), (2) and (3) is explained: Personality rights constrain ownership rights, while the exploitation of intellectual property rights is constrained by both personality rights and ownership rights. All of these rights applicable to personal genomic sequence data should be acknowledged and harmonized for such data to be used effectively.

Further reading

Thaldar DW, Townsend BA, Donnelly D-L, Botes M, Gooden A, Van Harmelen J, Shozi B. The multidimensional legal nature of personal genomic sequence data: A South African perspective. Frontiers in Genetics. 2022.

See also

Thaldar DW, Shozi B. The legal status of human biological material used for research. South African Law Journal. 2021.

Thaldar DW. Why POPIA does not apply to DNA. South African Journal of Science. 2021.

Funding

This episode was made possible by a grant from the U.S. National Institute of Mental Health and the U.S. National Institutes of Health (award number U01MH127690) under the Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) program. The content of this podcast is solely the responsibility of discussants of the podcast and does not necessarily represent the official views of the U.S. National Institute of Mental Health or the U.S. National Institutes of Health.

In this podcast episode, Professor Donrich Thaldar and Dr Dusty-Lee Donnelly discuss the new data transfer agreement (DTA) template (beta version) that is now available for public comment.

The DTA template (beta version) can be accessed here: https://doi.org/10.5281/zenodo.7110269

Comments can be emailed to [email protected] by no later than 15 November 2022.

Funding

This podcast was made possible by a grant from the U.S. National Institute of Mental Health and the U.S. National Institutes of Health (award number U01MH127690) under the Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) program. The content of this podcast is solely the responsibility of discussants of the podcast and does not necessarily represent the official views of the U.S. National Institute of Mental Health or the U.S. National Institutes of Health.