Melodie Labuschaigne
@unisa.ac.za
Professor, Department of Jurisprudence
University of South Africa
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
Scopus Publications
Scholar Citations
Scholar h-index
Scholar i10-index
Scopus Publications
D Thomson and M Labuschaigne
South African Medical Association NPC
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.
M Labuschaigne, E Auret, and N Mabeka
South African Medical Association NPC
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.
Melodie Labuschaigne, Safia Mahomed, and Ames Dhai
Wiley
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.
Ciara Staunton, Rachel Adams, Lyn Horn, and Melodie Labuschaigne
Springer International Publishing
M Kwinda, M Labuschaigne, and M Slabbert
South African Medical Association NPC

 
 
 
 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.
 
 
 
Melodie Labuschaigne and Ciara Staunton
Routledge
Melodie Labuschaigne and Magda Slabbert
Springer International Publishing
Marian Loveday, Ameena Goga, Ames Dhai, Melodie Labuschaigne, Theresa Roussouw, Theresa Burgess, Ann Strode, Melissa Wallace, Marc Blockman, Brodie Daniels,et al.
AOSIS
Background: Adolescents are a unique population with significant unmet health needs. They are often excluded from research that may benefit them as they are perceived as vulnerable and needing protection from research participation. For Research Ethics Committees, conflicting positions in statutes, regulations and ethical guidelines about who provides informed consent for adolescent involvement in health research can be a significant barrier to approving adolescent research. For researchers, the requirement for parental/guardian proxy consent or prolonged approval processes may potentially result in the exclusion of those adolescents most vulnerable and at risk, particularly if issues such as gender-based violence, gender identity, sexuality and sexual practices are in question.Objectives: To describe the challenges to adolescent research and suggest strategies to address these.Method: We consider the legal and ethical framework in South Africa regarding the consenting age for adolescents in research, outline the challenges and, using examples of best practices, suggest strategies to address the current conundrum.Results: We suggest three principles to guide Research Ethics Committees on their approach to reviewing health research involving adolescents. Strategies to develop ethically acceptable approaches to adolescent research and consent processes are described, which include community involvement. We elaborate on examples of nuanced approaches to adolescent research.Conclusion: The inclusion of adolescents in research is critical in informing appropriate and effective health services for this vulnerable population, whilst providing an opportunity to link them into care and services where relevant.
S Mahomed and M L Labuschaigne
South African Medical Association NPC
While open science gains prominence in South Africa with the encouragement of open data sharing for research purposes, there are stricter laws and regulations around privacy – and specifically the use, management and transfer of personal information – to consider. The Protection of Personal Information Act No. 4 of 2013 (POPIA), which came into effect in 2021, established stringent requirements for the processing of personal information and has changed the regulatory landscape for the transfer of personal information across South African borders. At the same time, draft national policies on open science encourage wide accessibility to data and open data sharing in line with international best practice. As a result, the operation of research ethics committees (RECs) in South Africa is affected by the conflicting demands of the shift towards open science on the one hand, and the stricter laws protecting participants’ personal information and the transfer thereof, on the other. This article explores the continuing evolving role of RECs in the era of open data and recommends the development of a data transfer agreement (DTA) for the ethical management of personal health information, considering the challenges that RECs encounter, which centres predominantly on privacy, data sharing and access concerns following advances in genetic and genomic research and biobanking.
Safia Mahomed, Melodie Labuschaigne, and Magda Slabbert
South African Medical Association NPC
Private medical aids are essentially non-profit organisations that aim to deliver speedy treatment and should prevent members from unexpected, out of pocket expenses for medical care. However, although the latest statistics show that 16.2% of individuals in South Africa were members of medical aid schemes, making the promise of private healthcare accessible to a small percentage of the population, they are not without their own unique set of challenges. The restrictions that exist within the private sector have a direct bearing on the types of healthcare services patients can access, which in turn impacts on the fundamental right to access healthcare. Using a recent High Court Case decision, this article seeks to explore whether there is justice in the provision of healthcare services, specifically within the private sector in South Africa.
M Slabbert and M Labuschaigne
South African Medical Association NPC

 The doctor-patient relationship is the foundation of any medical intervention. Over time, the relationship has changed, from the era of paternalism to the era of self-determination or patient autonomy, following changes resulting from consumerism and lately, in South Africa, socialised medicine as a result of the proposed National Health Insurance (NHI). The premise of this article is that patient autonomy is invariably limited by a determination of who will carry the cost of a medical intervention. In recent years, legislative developments have affected the understanding of a patient and doctor through the introduction of new references, such as ‘user’, ‘data subject’ and ‘consumer’ for a patient, and ‘service provider’ and ‘responsible party’ for a doctor, each giving different meanings to the doctor-patient relationship. Recent statutory additions also include new remedies available to aggrieved patients as parties in the doctor-patient relationship. The article concludes with brief observations on how the NHI will alter the essence and nature of the doctor-patient relationship in future.
 
Marietjie Botes, Melodie Nöthling Slabbert, and Antonel Olckers
Academy of Science of South Africa
Realisation of the value and the commercialisation potential of data is gaining exponential momentum. The combination of historical data exploitations and the use of technologies that allow for the triangulation of data results in the collection, storage, and processing of massive amounts of data require diligent data management, including adherence to privacy and other laws, both nationally and internationally. The intrinsic value of scientific data, especially in genomics, becomes apparent when data are shared, often in collaboration with international partners, and compiled into big data sets that are subsequently used for benefit, including commercial benefit. The purpose of this article is to explore the commercialisation of data in South Africa against the backdrop of the legal framework governing the protection of personal information, confidentiality and privacy, with a specific focus on genetic and genomic information. Related issues, such as the collection and sharing of data, ownership of data and challenges about informed consent are also considered. After a brief evaluation of the African regulatory landscape relating to the protection of personal information, the article concludes with a few recommendations aimed at improving the status quo and sensitising the South African public as to the value of their data and personal information, as well as the potential uses and abuses to which their personal information may be subjected
M Labuschaigne, M Slabbert, S Budree, E Hoosien, A Brink, and M Blockman
South African Medical Association NPC
The purpose of this article, the last in a series of three exploring the legal framework for the regulation of faecal microbiota transplantation (FMT) in South Africa (SA), is to determine the regulatory framework that applies to microbial-based treatments involving a level of manipulation that exceeds that of basic stool transplantation, e.g. processed FMT-derived products in capsule form. The article highlights the legal requirements for the registration of these products as biological medicines in SA law. Although human stool banks are not regulated in terms of the National Health Act 61 of 2003 (NHA) and regulations, the earlier articles point out that human stool fits the definition of human tissue and human biological material as defined by the NHA. For this reason, stool banks should be considered tissue banks in terms of the NHA and regulations. Healthcare practitioners and researchers involved in FMT banking and transplantation should strive to comply with these regulations in the absence of clear legal direction at present.
M Labuschaigne, M Slabbert, S Budree, E Hoosien, A Brink, and M Blockman
South African Medical Association NPC
The legal regulation of faecal microbiota transplantation (FMT) in South Africa (SA) is currently unclear. The purpose of this article, the first of three in a series, is to explore the nature, role and clinical application of FMT in SA in order to determine, from a legal perspective, the appropriate regulatory pathways governing FMT as a procedure that may combine approaches for the treatment of drugs, human tissue for transplantation, or clinical treatment as part of the practice of medicine. FMT has been shown to be a novel, safe and effective treatment for recurrent Clostridioides difficile infection (CDI). Stool banks are instrumental in enabling access to FMT for patients and clinicians and help to catalyse research in the microbiome. However, the regulatory landscape in SA remains unclear. Microbial therapies such as FMT are necessary, especially in a time of rising microbiome-associated inflammatory diseases and increasing resistance to traditional antibiotics. FMT is now considered as part of the standard of care for recurrent CDI overseas, but is currently only being used for research purposes in a minority of clinical cases of CDI in SA. This article, which lays the foundation for consideration of this question in three parts, suggests that the relevant regulatory system would depend on the categorisation of human stool as tissue, the exact composition of the FMT, how it is administered to patients, and the relevant levels of manipulation of the stool for FMT-derived products.
M Labuschaigne, M Slabbert, S Budree, E Hoosien, A Brink, and M Blockman
South African Medical Association NPC
Faecal microbiota transplantation (FMT) has been shown to be an effective treatment for recurrent Clostridioides difficile infection. The purpose of this article, the second of a series of three articles, is to explore the legal framework governing human FMT in South Africa (SA). FMT involves different modes of administration that require different regulatory considerations. The focus of this article is to explore the legal classification of human stool as tissue in terms of the National Health Act 61 of 2003, as well as the regulation of human stool banks as tissue banks. The article concludes with specific recommendations aimed at improving the current regulatory vacuum relating to the regulation of FMT in SA.
D W Thaldar, B Townsend, C Staunton, R Adams, M Botes, E S Dove, L Horn, M Labuschaigne, G Loots, S Mahomed,et al.
South African Medical Association NPC
Letter by Thaldar and Townsend, following an article by the same authors (Thaldar D, Townsend B. Genomic research and privacy: A response to Staunton et al. S Afr Med J 2020;110(3):172-174. https://doi.org/10.7196/SAMJ.2020.v110i3.14431) and both commenting on an article by Staunton et al. (Staunton C, Adams R, Botes M, et al. Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013. S Afr Med J 2019;109(7):468-470. https://doi.org/10.7196/SAMJ.2019.v109i7.14148); and response to article and letter by Staunton et al.
Ciara Staunton, Carmen Swanepoel, and Melodie Labuschaigne
Oxford University Press (OUP)
CITATION: Staunton, C., Swanepoel, C. & Labushagine, M. 2020. Between a rock and a hard place : COVID-19 and South Africa’s response. Journal of Law and the Biosciences, lsaa052, doi:10.1093/jlb/lsaa052.
S Mahomed and M Labuschaigne
South African Medical Association NPC
M Labuschaigne and S Mahomed
South African Medical Association NPC
The demand for human tissue in the medical context has increased rapidly since the early 1980s, when the use of human bone in allografts in orthopaedic surgery became the norm. During the 1990s, the demand for human tissue turned towards tissue-engineered products in the field of regenerative medicine. Tissue engineering, as an established and growing interdisciplinary field comprising different specialties, such as medicine, materials science, cell biology, genomics and chemical engineering, aims to develop biological substitutes to restore, maintain or improve tissue function, thus offering patients the chance to regain normal functionality in their bodies. The purpose of this article is to explore some of the gaps that exist in the current regulatory framework that governs tissue banks in South Africa (SA), and to make certain recommendations aimed at closing these gaps. The discrepancies and gaps cause confusion and may lead to undesired and unforeseen consequences regarding the use of human tissue, as well as prejudice the welfare of patients in SA.
M Labuschaigne, A Dhai, S Mahomed, K Behrens, A Nienaber, K Moodley, P Cleaton-Jones, A Olckers, N Maepa, and C Penny
South African Medical Association NPC
The need to transfer human biological materials (HBMs) across national boundaries has become increasingly important in view of increased biobank and commercial activities globally. In light of South Africa (SA)'s history of colonisation and racial discrimination, coupled with well-known instances of exploitation of research participants in the developing world, it is critical that the management of HBMs from and to other jurisdictions is explored and regulated. Material transfer agreements (MTAs) represent an important point of departure in such a process. This article explores the need for a uniform MTA in SA and discusses some aspects of the recently gazetted national MTA, which provides a framework that can serve as a safeguard for cross-border transfer of HBMs in the absence of the National Health Act's chapter 8 regulations in this regard.
Michael S. Pepper, Collet Dandara, Jantina De Vries, Amaboo Dhai, Melodie Labuschaigne, Freddy Mnyongani, Keymanthri Moodley, Antonel Olckers, Anne Pope, Raj Ramesar,et al.
Academy of Science of South Africa
Volume 115| Number 7/8 July/August 2019 Commentary https://doi.org/10.17159/sajs.2019/a0312 © 2019. The Author(s). Published under a Creative Commons Attribution Licence. An optimistic vision for biosciences in South Africa: Reply to Thaldar et al. (2019) AUTHORS: Michael S. Pepper1,2 Collet Dandara3 Jantina de Vries4 Amaboo Dhai5 Melodie Labuschaigne6 Freddy Mnyongani7 Keymanthri Moodley8 Antonel Olckers9 Anne Pope10 Raj Ramesar11 Michèle Ramsay12 Wayne Towers13
C Staunton, R Adams, M Botes, E S Dove, L Horn, M Labuschaigne, G Loots, S Mahomed, J Makuba, A Olckers,et al.
South African Medical Association NPC
Genomic research has been identified in South Africa (SA) as important in developing a strong bio-economy that has the potential to improve human health, drive job creation and offer potential solutions to the disease burden harboured by low- and middle-income countries. Central to the success of genomic research is the wide sharing of biological samples and data, but the true value of data can only be unlocked if there are laws and policies in place that foster the legal and ethical sharing of genomic data. The introduction and entry into force of SA's Protection of Personal Information Act (POPIA) No. 4 of 2013 is to be welcomed, but the wording of POPIA as it pertains to consent for the processing of personal information for research purposes has sparked a debate about the legal status of broad consent. We argue that a purposive interpretation of the legislation would permit broad consent for the processing of personal information for research. Although there are ongoing debates surrounding the ethical use of broad consent in Africa, the objective of this article is not to engage with the ethics of broad consent itself, but rather to focus on the legal status of broad consent for genomic data sharing under POPIA.
Michael S. Pepper, Collet Dandara, Jantina De Vries, Amaboo Dhai, Melodie Labuschaigne, Freddy Mnyongani, Keymanthri Moodley, Antonel Olckers, Anne Pope, Raj Ramesar,et al.
Academy of Science of South Africa
CITATION: Pepper, M. S., et al. 2018. ASSAf consensus study on the ethical, legal and social implications of genetics and genomics in South Africa. South African Journal of Science, 114(11/12), Art. #a0302, doi:10.17159/sajs.2018/a0302.