Health Law

About Health Law

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.

Publisher

Prof. Donrich Thaldar

Category

education

Language

en

Explicit

No

First episode

12 Aug 2022

Latest episode

2 Apr 2024

Latest episodes

21 episodes in the feed.

1. 

   2 Apr 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 (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 (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 (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 (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 (https://doi.org/10.1057/s41599-020-00600-0)

2. 

   2 Oct 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 (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 (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 (https://doi.org/10.17159/sajs.2023/15069)

3. 

   31 Aug 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 (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 (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 (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 (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.

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