Health Law

Prof. Donrich Thaldar

New developments in science and technology, such as genome sequencing and AI promise to improve our healthcare. But how does our law govern the use of these new technologies in healthcare? Does our law strike a good balance between promoting health innovation and protecting the rights of individuals --patients and research participants? These are the fascinating and important questions that we explore in our podcast series.

  1. Not fit for purpose: The NHREC’s draft revised MTA

    04/02/2024

    Not fit for purpose: The NHREC’s draft revised MTA

    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. https://doi.org/10.3389/fphar.2024.1333672 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). https://doi.org/10.5281/zenodo.7537396 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. https://doi.org/10.7196/SAJBL.2023.v16i1.827 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. https://doi.org/10.1186/s12910-020-00526-x 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) https://doi.org/10.1057/s41599-020-00600-0

    9 min
  2. Ethical considerations in establishing an open access genomics database in South Africa.

    10/02/2023

    Ethical considerations in establishing an open access genomics database in South Africa.

    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. https://doi.org/10.3389/fgene.2023.1166029 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. https://doi.org/10.3389/fgene.2023.1248747 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. https://doi.org/10.17159/sajs.2023/15069

    7 min
  3. Data Transfer Agreement (DTA) template for the South African research community

    08/31/2023

    Data Transfer Agreement (DTA) template for the South African research community

    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). https://doi.org/10.5281/zenodo.7537396 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. https://doi.org/10.7196/SAJBL.2023.v16i1.827 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. https://doi.org/10.1186/s12910-020-00526-x 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) https://doi.org/10.1057/s41599-020-00600-0 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.

    10 min
  4. Ownership of the HeLa cell line - a South African perspective

    08/31/2023

    Ownership of the HeLa cell line - a South African perspective

    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. https://academic.oup.com/jlb/article/10/1/lsad011/7165261 See also Thaldar DW, Shozi B. The legal status of human biological material used for research. South African Law Journal. 2021. https://www.jutajournals.co.za/the-legal-status-of-human-biological-material-used-for-research/ 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.

    10 min
  5. Why Africa should abandon the idea of genomic sovereignty in research involving humans

    08/31/2023

    Why Africa should abandon the idea of genomic sovereignty in research involving humans

    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.

    7 min
  6. The res nullius construction of human genomic data

    08/31/2023

    The res nullius construction of human genomic data

    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). https://doi.org/10.3389/fgene.2022.997595 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.

    12 min
  7. Is it time to reconsider the genetic link requirements?

    03/28/2023

    Is it time to reconsider the genetic link requirements?

    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

    22 min
  8. Scientific freedom

    12/15/2022

    Scientific freedom

    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. https://doi.org/10.47348/SALJ/v138/i2a2

    12 min
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New developments in science and technology, such as genome sequencing and AI promise to improve our healthcare. But how does our law govern the use of these new technologies in healthcare? Does our law strike a good balance between promoting health innovation and protecting the rights of individuals --patients and research participants? These are the fascinating and important questions that we explore in our podcast series.

Information

  • Creator
    Prof. Donrich Thaldar
  • Years Active
    2022 - 2024
  • Episodes
    21
  • Rating
    Clean
  • Copyright
    © Prof. Donrich Thaldar
  • Show Website
    Health Law