Melodie Labuschaigne

@unisa.ac.za

Professor, Department of Jurisprudence
University of South Africa

Melodie Labuschaigne


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https://researchid.co/slabbmn

EDUCATION

BA, BA(Hons), MA, DLitt (UP); LLB, LLD (Unisa)

RESEARCH INTERESTS

Medical law and ethics; legal regulation of biotechnology; stem cell regulation; genomic research regulation; law and literature
29

Scopus Publications

990

Scholar Citations

15

Scholar h-index

27

Scholar i10-index

Scopus Publications

  • Ethicolegal framework for the regulation of human faecal microbiota transplants in South Africa: Progress, challenges and recommendations
    M Labuschaigne
    South African Journal of Bioethics and Law, 2026
    This article examines the ethicolegal challenges in regulating faecal microbiota transplantation (FMT) in South Africa (SA), where a regulatory vacuum under the National Health Act 61 of 2003 (NHA) and Medicines and Related Substances Act 101 of 1965 (MRSA) hinders the implementation of FMT. FMT effectively treats recurrent Clostridioides difficile infection by restoring gut microbiome balance, with potential for broader applications, but lacks clear classification as human tissue, biological material, or a medicine under the existing framework. The article suggests regulatory classifications for the different types of human stool under both the NHA and the MRSA. Drawing on relevant guidelines issued by the Food and Drug Administration in the USA and the European Medicines Agency, including the 2024 European Union’s Substances of Human Origin (SoHO) Regulation, which standardises microbiota safety and traceability, the article concludes with recommendations aimed at closing the existing regulatory vacuum concerning FMT in SA.
  • Embedding equity in clinical research governance
    Johanna M. C. Blom, Ciara Staunton, Sophie Tascedda, Neil Slabbert, Luca Pani, et al.
    Nature Medicine, 2026
  • Contextualising Mental Privacy in South Africa: Legal, Ethical, and Socio-Cultural Considerations With Policy Recommendations
    Marietjie Botes, Melodie Labuschaigne, Camille Casteleyn, Becky Inkster, Mark Sheppard
    Developing World Bioethics, 2026
    Mental privacy is a growing concern as neurotechnologies and digital mental health tools collect and process sensitive brain‐related data. In South Africa, cultural and religious diversity adds complexity to protecting mental privacy, with traditional healing practices, communal decision‐making, and spiritual beliefs influencing mental health perceptions and care. This article examines the ethical, legal, and socio‐cultural challenges of mental privacy in South Africa, focusing on cognitive autonomy, informed consent, and exploitation risks. It critiques global regulatory frameworks, highlighting the limitations of the EU's GDPR and the fragmented US approach in addressing culturally diverse and economically unequal contexts. The article proposes enhancements to South Africa's Protection of Personal Information Act, emphasising the need for explicit classification of neural and mental health data as sensitive categories. Additionally, it recommends culturally informed consent processes, collaboration with traditional and religious leaders, and public awareness initiatives to ensure inclusive mental privacy protections that respect cultural diversity while safeguarding individual rights.
  • Decoding the Brain, Respecting the Person: A Neuroethical Inquiry into Consent and Cognitive Liberty in South Africa
    Marietjie Botes, Melodie Labuschaigne, Camille Casteleyn, Becky Inkster, Mark Sheppard
    Neuroethics, 2025
    As neurotechnologies emerge in South Africa's clinical, research, and consumer health landscapes, existing informed consent models, predominantly shaped by Western individualist ethics, prove insufficient. Neural data, uniquely intimate and increasingly commodified, poses profound ethical and legal risks, including mental privacy violations, behavioural profiling, and cultural alienation. This article interrogates these risks through a neuroethical lens grounded in African relational philosophy, particularly Ubuntu, which emphasises communal personhood, collective decision-making, and spiritual interconnectedness. We analyse the limitations of South African and international legal frameworks, arguing that they neither adequately recognise neural data as a distinct category nor accommodate culturally appropriate consent processes. In response, we propose a pluralistic, relational consent framework that incorporates tiered, dynamic, and interactive mechanisms, sensitive to linguistic, educational, and spiritual diversity. By centring cognitive liberty and advocating for sui generis neurorights protections, this paper contributes a decolonial, culturally situated perspective to global neuroethics and informs more inclusive governance models for neural technologies in legally and socially pluralistic societies.
  • Organ donation after circulatory death – legal in South Africa and in alignment with Chapter 8 of the National Health Act and Regulations relating to organ and tissue donation
    D Thomson, M Labuschaigne
    South African Journal of Bioethics and Law, 2024
    Organ donation after a circulatory determination of death is possible in selected patients where consent is given to support donation and the patient has been legally declared dead by two doctors. The National Health Act (61 of 2003) and regulations provide strict controls for the certification of death and the donation of organs and tissues after death. Although the National Health Act expressly recognises that brain death is death, it does not prescribe the medical standards of testing for the determination of brain death (neurological determination of death), circulatory death (circulatory determination of death) or for determination of death based on somatic criteria. However, in all cases of organ donation, including after circulatory death, the National Health Act mandates that two doctors certify the death, with one doctor possessing more than 5 years of experience. Additionally, both doctors must be independent from the transplant team. The standard for such determination, as for brain death, aligns with accepted medical standards. The Critical Care Society of Southern Africa has published South African (SA) Guidelines on Death Determination that outline rigorous standards for death determination in hospital settings by either a neurological or circulatory method. Legislation and the Health Professions Council of SA’s (HPCSA) professional guidance direct clinicians on obtaining informed consent for donation either from the patient or in cases of incapacity from their surrogate decision maker. Collectively, the legislation, regulations and professional guidelines in SA provide a robust ethical framework that supports organ donation after circulatory death.
  • THE PROCUREMENT, REMOVAL AND USE OF HUMAN TISSUE AND ORGANS IN SOUTH AFRICAN LAW: A LEGAL-HISTORICAL ANALYSIS
    Melodie Labuschaigne, Magda Slabbert
    Fundamina, 2024
    The current legal framework regulating human tissue and organ procurement, removal and use is inconsistent, inadequate and often ambiguous. By tracing the legal developments relating to the regulation of human tissue and organs since the inception of the first South African regulatory framework in 1952, this contribution seeks to determine the origin of existing limitations and challenges pertaining to this field. Case law is also discussed to illustrate the lack of understanding and complexity regarding the application of the relevant provisions in a practical context. The study concludes with a number of recommendations aimed at closing the identified gaps, based on past best practice emerging from the legal-historical analysis conducted.
  • Surrogate motherhood regulation in South Africa: Medical and ethico-legal issues in need of reform
    M Labuschaigne, E Auret, N Mabeka
    South African Journal of Bioethics and Law, 2024
    Chapter 19 of the Children’s Act No. 32 of 2005 regulates the practice of surrogate motherhood in South Africa and provides legal certainty regarding the rights of the children born as a result of surrogacy, including the rights of the different parties involved. Despite the clarity regarding the legal consequences of human reproduction by artificial fertilisation of women acting as surrogate mothers, some legal gaps and inconsistencies regarding certain medical and ethico-legal issues remain. The purpose of this article is to critically examine selected provisions whose implementation is hampered by a lack of detail or clarity, compromising compliance by the different parties to the surrogate motherhood agreement. The article concludes with recommendations on how some of these issues may be addressed to provide for legal certainty and transparency.
  • Evolving capacity of children and their best interests in the context of health research in South Africa: An ethico-legal position
    Melodie Labuschaigne, Safia Mahomed, Ames Dhai
    Developing World Bioethics, 2023
    The existing ethico-legal regulation of adolescent children's participation in health research in South Africa is currently unclear. The article interrogates the existing framework governing children's consent to research participation, with specific emphasis on discrepancies in consent norms in law and ethical guidelines. Against the backdrop of the constitutional directive that requires that a child's best interests are of paramount importance in every matter concerning the child, the article assesses whether sufficient consideration is given to children's evolving maturity and capacities when consent to their participation in health research is sought. The article provides specific recommendations and proposes a legislative change to consent provisions in the National Health Act 61 of 2003 in order to address the existing lacunae and to align the framework with constitutional imperatives and international fundamental rights considerations.
  • A Framework to Govern the Use of Health Data for Research in Africa: A South African Perspective
    Ciara Staunton, Rachel Adams, Lyn Horn, Melodie Labuschaigne
    Philosophy and Medicine, 2023
  • Disciplinary proceedings against healthcare practitioners facing criminal charges: The role of the Health Professions Council of South Africa
    M Kwinda, M Labuschaigne, M Slabbert
    South African Journal of Bioethics and Law, 2022
    
 
 
 
 The purpose of this article is to address the questions as to whether a criminal conviction of a healthcare practitioner should affect his or her professional standing, and whether such conviction constitutes ‘unprofessional conduct’ in terms of the Health Professions Act. The article also explores a related matter, namely whether the Health Professions Council of South Africa (HPCSA) has a legal duty to refer complaints regarding unprofessional conduct that displays criminal elements for criminal prosecution. After considering relevant case law on these issues, the article concludes that a practitioner, after being convicted of an offence, should be afforded an opportunity to explain him- or herself to the board, not only in extenuation of the conduct in question, but also in response to the question of whether the conduct constitutes improper or disgraceful conduct. Moreover, the article explains why the HPCSA and professional boards have a legal duty to refer matters of unprofessional conduct with criminal elements in terms of section 34 of the Prevention and Combating of Corrupt Activities Act to law enforcement agencies.
 
 
 
  • The rationality of South Africa's state of disaster during COVID-19
    Melodie Labuschaigne, Ciara Staunton
    Routledge Handbook of Law and the Covid 19 Pandemic, 2022
  • Research Involving Human Participants and Their Biological Material: A South African Perspective
    Melodie Labuschaigne, Magda Slabbert
    Integrity of Scientific Research Fraud Misconduct and Fake News in the Academic Medical and Social Environment, 2022
  • The evolving role of research ethics committees in the era of open data
    S Mahomed, M L Labuschaigne
    South African Journal of Bioethics and Law, 2022
  • Legal reflections on the doctor-patient relationship in preparation for South Africa’s National Health Insurance
    M Slabbert, M Labuschaigne
    South African Journal of Bioethics and Law, 2022
  • Justice in the provision of healthcare services – a stifled right in the private sector
    Safia Mahomed, Melodie Labuschaigne, Magda Slabbert
    South African Journal of Bioethics and Law, 2022
  • Ethically acceptable consent approaches to adolescent research in South Africa
    Marian Loveday, Ameena Goga, Ames Dhai, Melodie Labuschaigne, Theresa Roussouw, et al.
    Southern African Journal of HIV Medicine, 2022
  • Data commercialisation in the south african health care context
    Marietjie Botes, Melodie Nöthling Slabbert, Antonel Olckers
    Potchefstroom Electronic Law Journal, 2021
  • The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 3. Stool as a 'drug' or medicine
    M Labuschaigne, M Slabbert, S Budree, E Hoosien, A Brink, et al.
    South African Medical Journal, 2020
  • The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 2. Human stool as tissue?
    M Labuschaigne, M Slabbert, S Budree, E Hoosien, A Brink, et al.
    South African Medical Journal, 2020
  • The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 1. A legal vacuum
    M Labuschaigne, M Slabbert, S Budree, E Hoosien, A Brink, et al.
    South African Medical Journal, 2020
  • Ethicolegal issues relating to the south african government’s response to covid-19
    South African Journal of Bioethics and Law, 2020
  • Privacy rights of human research participants in South Africa must be taken seriously
    D W Thaldar, B Townsend, C Staunton, R Adams, M Botes, et al.
    South African Medical Journal Suid Afrikaanse Tydskrif Vir Geneeskunde, 2020
  • Between a rock and a hard place: COVID-19 and South Africa's response
    Ciara Staunton, Carmen Swanepoel, Melodie Labuschaigne
    Journal of Law and the Biosciences, 2020
  • The role of research ethics committees in South Africa when human biological materials are transferred between institutions
    S Mahomed, M Labuschaigne
    South African Journal of Bioethics and Law, 2019
  • Regulatory challenges relating to tissue banks in South Africa: Impediments to accessing healthcare
    M Labuschaigne, S Mahomed
    South African Journal of Bioethics and Law, 2019

RECENT SCHOLAR PUBLICATIONS

  • Contextualising Mental Privacy in South Africa: Legal, Ethical, and Socio‐Cultural Considerations With Policy Recommendations
    M Botes, M Labuschaigne, C Casteleyn, B Inkster, M Sheppard
    Developing World Bioethics , 2026
    2026
  • Ethicolegal framework for the regulation of human faecal microbiota transplants in South Africa: Progress, challenges and recommendations
    M Labuschaigne
    South African Journal of Bioethics and Law 19 (1), 47-51 , 2026
    2026
  • Embedding equity in clinical research governance
    JMC Blom, C Staunton, S Tascedda, N Slabbert, L Pani, M Labuschaigne
    Nature medicine, 1-3 , 2026
    2026
  • Decoding the Brain, Respecting the Person: A Neuroethical Inquiry into Consent and Cognitive Liberty in South Africa
    M Botes, M Labuschaigne, C Casteleyn, B Inkster, M Sheppard
    Neuroethics 18 (3), 43 , 2025
    2025
    Citations: 3
  • Vonnisbespreking: Lidmaatskap van'n mediese skema kan nie sonder grondige redes beëindig word nie
    M Slabbert, M Labuschaigne
    Litnet Akademies:'n Joernaal vir die Geesteswetenskappe, Natuurwetenskappe … , 2025
    2025
  • The Procurement, Removal and Use of Human Tissue and Organs in South African Law: A Legal-Historical Analysis
    M Labuschaigne, M Slabbert, N Ahmad, ZH Zamri, A Klopper
    Fundamina: A Journal of Legal History 30 (2), 1-32 , 2024
    2024
    Citations: 64
  • Surrogate motherhood regulation in South Africa: Medical and ethico-legal issues in need of reform
    M Labuschaigne, E Auret, N Mabeka
    South African Journal of Bioethics and Law 17 (3), 104-108 , 2024
    2024
    Citations: 2
  • Organ donation after circulatory death-legal in South Africa and in alignment with Chapter 8 of the National Health Act and Regulations relating to organ and tissue donation
    D Thomson, M Labuschaigne
    South African Journal of Bioethics and Law 17 (1), 41-43 , 2024
    2024
    Citations: 1
  • Rendering First Aid: The Legal Position
    M Slabbert, M Labuschaigne
    THRHR 87, 294 , 2024
    2024
  • Powers of the Registrar of the Health Professions Council to institute investigations under the Health Professions Act 56 of 1974
    MA Kwinda, M Labuschaigne, M Slabbert
    De Jure Law Journal 57 (1), 17-23 , 2024
    2024
  • Public Health Crisis Management and Criminal Liability of Governments: A Comparative Study of the Covid-19 Pandemic eds. by Bohlander M, Kemp G, Webster M
    M Labuschaigne
    South African Journal of Criminal Justice 36 (3), 481-484 , 2023
    2023
  • Evolving capacity of children and their best interests in the context of health research in South Africa: An ethico‐legal position
    M Labuschaigne, S Mahomed, A Dhai
    Developing World Bioethics 23 (4), 358-366 , 2023
    2023
    Citations: 3
  • Vonnisbespreking: Mediese nalatigheid-vertraging in oorplasing van pasiënt na geskikte sorg; en of nalatigheid oorsaaklik verband hou met amputasie van pasiënt se been Louw v …
    M Slabbert, M Labuschaigne
    Litnet Akademies:'n Joernaal vir die Geesteswetenskappe, Natuurwetenskappe … , 2023
    2023
  • Nierversaking en ’n orgaanoorplanting in Met ’n ompad deur Berna Ackerman – ’n regsletterkundige ondersoek
    M Labuschaigne, M Slabbert
    Litnet Akademies:'n Joernaal vir die Geesteswetenskappe, Natuurwetenskappe … , 2023
    2023
  • Towards a data transfer agreement for the South African research community: the empowerment approach
    L Swales, M Botes, D Donnelly, D Thaldar
    South African journal of bioethics and law 16 (1), 13-18 , 2023
    2023
    Citations: 13
  • A framework to govern the use of health data for research in Africa: a South African perspective
    C Staunton, R Adams, L Horn, M Labuschaigne
    Medical research ethics: challenges in the 21st century, 485-499 , 2023
    2023
    Citations: 3
  • A South African Perspective
    C Staunton, R Adams, L Horn, M Labuschaigne
    Medical Research Ethics: Challenges in the 21st Century, 485 , 2023
    2023
  • Inconsistent and Irregular Approaches in the Handling of Complaints by the Health Professions Council of South Africa: Haeck v Health Professions Council of South Africa (2021 …
    M Slabbert, M Labuschaigne, M Kwinda
    THRHR 86, 394 , 2023
    2023
    Citations: 1
  • " Crying over Spilled Milk?" The Legal Regulation of Breast Milk in South Africa
    M Slabbert, M Labuschaigne
    THRHR 86, 213 , 2023
    2023
  • Research Involving Human Participants and Their Biological Material: A South African Perspective
    M Labuschaigne, M Slabbert
    Integrity of Scientific Research: Fraud, Misconduct and Fake News in the … , 2022
    2022

MOST CITED SCHOLAR PUBLICATIONS

  • International surrogacy arrangements: legal regulation at the international level
    K Trimmings, P Beaumont
    Bloomsbury Publishing , 2013
    2013
    Citations: 118
  • Between a rock and a hard place: COVID-19 and South Africa’s response
    C Staunton, C Swanepoel, M Labuschaigne
    Journal of Law and the Biosciences 7 (1), lsaa052 , 2020
    2020
    Citations: 103
  • Is South Africa on the verge of a medical malpractice litigation storm?
    MS Pepper, MN Slabbert
    South African Journal of Bioethics and Law 4 (1), 29-35 , 2011
    2011
    Citations: 101
  • The Procurement, Removal and Use of Human Tissue and Organs in South African Law: A Legal-Historical Analysis
    M Labuschaigne, M Slabbert, N Ahmad, ZH Zamri, A Klopper
    Fundamina: A Journal of Legal History 30 (2), 1-32 , 2024
    2024
    Citations: 64
  • Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013
    C Staunton, R Adams, M Botes, ES Dove, L Horn, M Labuschaigne, ...
    SAMJ: South African Medical Journal 109 (7), 468-470 , 2019
    2019
    Citations: 35
  • Routledge handbook of law and the COVID-19 pandemic
    J Grogan, A Donald
    Routledge , 2022
    2022
    Citations: 33
  • A Room of Our Own: Legal Lacunae Regarding Genomic Sovereignty in South Africa
    MN Slabbert, MS Pepper
    THRHR 73, 432 , 2010
    2010
    Citations: 31
  • Ethicolegal issues relating to the South African government’s response to COVID-19
    M Labuschaigne
    South African Journal of Bioethics and Law 13 (1), 6-11 , 2020
    2020
    Citations: 29
  • Ethical, legal and social issues in the context of the planning stages of the Southern African Human Genome Programme
    J De Vries, M Slabbert, MS Pepper
    Med. & L. 31, 119 , 2012
    2012
    Citations: 25
  • The legal position on the classification of human tissue in South Africa: Can tissues be owned?
    S Mahomed, M Nothling-Slabbert, MS Pepper
    South African Journal of Bioethics and Law 6 (1), 16-20 , 2013
    2013
    Citations: 24
  • Colour discrimination against persons with albinism in South Africa
    M Mswela, M Nothling-Slabbert
    South African Journal of Bioethics and Law 6 (1), 25-27 , 2013
    2013
    Citations: 23
  • Human tissue legislation in South Africa stem cell research and therapy
    MS Pepper, M Nothling Slabbert
    South African Journal of Bioethics and Law 8 (sup-1), 4-11 , 2015
    2015
    Citations: 20
  • ASSAf consensus study on the ethical, legal and social implications of genetics and genomics in South Africa
    MS Pepper, C Dandara, J De Vries, A Dhai, M Labuschaigne, ...
    South African Journal of Science 114 (11-12), 1-3 , 2018
    2018
    Citations: 16
  • Managing Human Tissue Transfer Across National Boundaries–An Approach from an Institution in S outh A frica
    S Mahomed, K Behrens, M Slabbert, I Sanne
    Developing World Bioethics 16 (1), 29-35 , 2016
    2016
    Citations: 15
  • Medical information therapy and medical malpractice litigation in South Africa
    W Moore, MN Slabbert
    South African Journal of Bioethics and Law 6 (2), 60-63 , 2013
    2013
    Citations: 15
  • Stem cell tourism in South Africa: the legal position
    S Mahomed, MN Slabbert
    South African Journal of Bioethics and Law 5 (2), 69-73 , 2012
    2012
    Citations: 15
  • Medical Law in South Africa
    MN Slabbert
    Kluwer Law International , 2011
    2011
    Citations: 15
  • Ethical and practical issues to consider in the governance of genomic and human research data and data sharing in South Africa: a meeting report
    C Staunton, R Adams, ES Dove, N Harriman, L Horn, M Labuschaigne, ...
    AAS open research 2, 15 , 2019
    2019
    Citations: 14
  • Towards a data transfer agreement for the South African research community: the empowerment approach
    L Swales, M Botes, D Donnelly, D Thaldar
    South African journal of bioethics and law 16 (1), 13-18 , 2023
    2023
    Citations: 13
  • Prosecuting animals in medieval Europe: Possible explanations
    M Slabbert
    Fundamina: A Journal of Legal History 2004 (10), 159-179 , 2004
    2004
    Citations: 12