Medical Law

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Access to affordable life-saving medicines : the South African response.
(2012) Joseph, Coral Jade.; Vawda, Yousuf Abdoola.
Patent protection grants the patent holder with a market monopoly, free from market competition allowing the patentee to charge any price; therefore medicines are sold at prices much higher than the marginal cost of production and distribution. The connection between international trade and intellectual property has aggravated human rights and public health concerns surrounding the inaccessibility of essential medicines. The World Trade Organisation‘s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement is an international instrument which has greatly impacted intellectual property rights protection and access to medicine. It has globalized intellectual property law by obliging all Members to subscribe to the minimum international standards of protection for intellectual property. South Africa is an example of the issues faced whilst attempting to bring their domestic laws into compliance with the Agreement. The government had to attempt to strike a balance between creating an effective intellectual property infrastructure whilst realizing the therapeutic needs of those affected by HIV/AIDS. The South African Patents Act 57 of 1978 did not comply with the Agreement and was subsequently amended in order to bring its patent legislation in full compliance with the Agreement. Currently, South Africa grants patents for new uses or formulations of existing medicines consequently lengthening the period of patent monopoly by allowing pharmaceutical companies to obtain new patents for slight modifications to existing medicines. It is submitted that South Africa‘s patent legislation is more extensive than is necessary under international law, examples of this being disclosure standards and the process for compulsory licensing. In addition, it has not made use of provisions in its existing law to take measures to improve access to essential medicines, nor has it implemented legislative amendments consequent to the flexibilities established in the Doha Declaration. This dissertation seeks to review the steps South Africa has taken in its compliance with the TRIPS Agreement with respect to the relevant intellectual property legislation that has been enacted, including its implications for access to essential medicines. The intention behind this dissertation is to assess the efficacy of the intellectual property legislation in South Africa and its impact on access to medicines.
Access to healthcare in the age of CRISPR: an analysis of the right to heritable human genome editing in the context of the tuberculosis epidemic in South Africa.
(2022) Kamwendo, Tamanda Agatha.; Thaldar, Donrich Willem.
Tuberculosis (TB) is the leading cause of death from infectious diseases in South Africa and a major risk to global health security. Although notable progress has been made towards TB control, its effectiveness has been limited, partly due to acquired resistance during the first-line TB treatment or poor patient adherence to the treatment. Considering that genetic factors play an important role in one’s susceptibility to TB, it is imperative that all aspects of vertices of the TB triad — a susceptible host gene, pathogen, and environment — be considered in formulating treatment. CRISPR-CasX is a revolutionary new approach to genetic modification that promises effective disease treatment and control in humans. This thesis explores the right to heritable human genome editing in South Africa in the specific context of TB treatment. Against this backdrop is the uncertainty of the ambit of the Constitutional commitment to ensure that all South Africans have access to healthcare services such as gene-editing services. As a result, the application of gene-editing technology for TB treatment is contingent on how this the right of access to healthcare services is interpreted. This thesis endeavours to show how the right of access to healthcare should be interpreted as being inclusive of access to geneediting technology. This study hence serves as an appraisal for South Africans on how to demand access to gene-editing services as a legal right in the search for a suitable treatment for TB. The thesis also provides momentum for South African policymaking by providing recommendations for research and the clinical use of CRISPR therapeutics as a medicinal product as the country has no gene-editing-specific policies or statutes.
Advancing human rights in patient care through strategic litigation: the case of Uganda.
(2022) Aruho, Amon.; Mnyongani, Freddy Duncan.
No abstract provided.
Affording patients the right to access experimental stem cell treatment: a comparative analysis of the legal and ethical consequences.
(2021) Gosai, Yadhna.; Botes, Wilhelmina Maria.
Despite revolutionary advances in the medical field, with specific reference to stem cell technologies and therapies, South African laws do not adequately address gaps that currently exist when it comes to legally accessing the various forms of experimental therapy. The Constitution of South Africa does make provision for the right to access health care, however most stem cell therapies are not yet approved or registered by the relevant authorities and can therefore not be considered as accessible health care. Patients are increasingly becoming aware of their rights when it comes to health care which may be partially linked to the advances in, and knowledge of medical professionals diagnosing and treating auto immune and other previously incurable diseases. While conventional treatments yield positive results, there are a number of incurable and novel diseases that cannot be managed with approved treatments. Stem cell therapies, currently still in its experimental phase have shown some great promise in treating and managing various diseases. The fact of the matter is that that access to such experimental therapies is limited. The rationale behind this is reasonable and justified. The safety and interests of patients are protected by numerous laws and ethical principles as such, if the safety and efficacy of medical treatments have not been clinically proven, it is not in the patient’s best interests to be subjected to such treatment. However, the principle of patient autonomy does support the position that a patient should be able to choose whether or not he or she wishes to be subjected to experimental medicines, such as stem cell therapies or not, on condition that they are fully informed about the risk and consequences of doing so. Against this background, other countries, such as the United States, have enacted laws to address the lack of access to potentially lifesaving treatments. Considering that the benefits of stem cell therapies are becoming more and more evident, access to these therapies whilst not yet fully clinically approved and registered as a medicine or therapy, should, in certain circumstances, be an option for those patients who have exhausted all legally available medicine and treatments without success. Laws that afford access to experimental medicine are seen as both controversial and progressive. A balance must therefore be struck between the individual patient’s right to access and his or her safety. Although expanded access programs have been around for a while, the restrictive nature of these programs often does not necessarily result in access to experimental therapies. It is important that there are viable, legal and ethical ways to access experimental stem cell therapies, whether through right to try laws or through expanded access programs.
An Afrocentric approach to CRISPR-Cas9: analysing the use of genetic technologies in human reproduction through the lens of human rights and African values.
(2021) Shozi, Bonginkosi.; Thaldar, Donrich Willem.
In the wake of the advent of genome editing technology CRISPR-Cas9, there has been global debate about the potential use of this technology on human gametes or embryos to create individuals with genetically modified genomes. This is a process commonly referred to as germline genome editing (GGE). Given that several countries, including South Africa (SA), have no regulation speaking to GGE, many proposals have been put forward regarding how this technology ought to be regulated in a way that attends to the ethical issues raised by the prospect of modifying the genomes of future generations. Within this global discourse, however, there are several material gaps. Most notably, the proposals have primarily been framed through a Eurocentric paradigm that omits material contextual considerations relevant to SA and the African continent. Furthermore, the proposals tend to be based on value judgements on ethical issues — such as the moral significance of the human genome — rooted in the Western philosophical tradition. This thesis endeavours to respond to these gaps by providing a novel theoretical approach to the regulation of GGE in South Africa, termed an ‘Afrocentric approach’. This approach entails responding to the legal, ethical and human rights issues related to GGE that is rooted in an African philosophical perspective on these issues, and that is sensitive to the realities of the South African context. This thesis concludes that SA ought to be open to the prospect of parents modifying the genomes of future offspring but must also place reasonable and evidence-based constraints on GGE. This thesis finds that there is a tenable argument that prospective parents have a ‘right to CRISPR’, but this right may be limited. Such limitations must be rationally related to the goals of (1) protecting public interests, or (2) promoting the best interests of the prospective child.
Apart from medical emergencies, when is it justified for gynaecologists, and obstetricians to deviate from informed consent without reverting back to their patients?
(2018) Naidoo, Loshinee.; McQuoid-Mason, David Jan.
Medical care relies on a bond of trust between the patient and caregiver and on the patient’s ability to make free and informed choices, to understand and guide the course of their care. Informed consent is the foundation of this trust, ensuring that the patient is adequately informed so as to best understand their options and decide their treatment path. Informed consent is an express legal mandate granted by a patient to a healthcare practitioner after consultation. The patient relies on the provided information when choosing to accept, reject, or seek to modify a proposed intervention. The patient is protected by Statutes that dictate the manner in which informed consent must be obtained, requiring that relevant information be provided in such a way that the patient understands the nature, intended effect, and risk or consequence associated with the intervention. In many cases, it must be established if the patient has the legal capacity to consent or not. This research topic will consider how proper enforcement of informed consent practices, procedures, and the implementation of current policies and rules in gynaecology and obstetrics may prevent cases of gross negligence, unlawful assault or the compromising of patient rights under the Constitution, the common law and specifically, the criminal law. The study aimed at: 1. Investigating under which circumstances, despite current legislation, policies and procedures, health practitioners choose and still adopt a paternalistic approach towards patients in their care in the field of gynaecology and obstetrics, which leads to deviations from the requirements of informed consent; 2. Obtaining explanations for cases where doctors, particularly in gynaecology and obstetrics, neglect patient autonomy and the need for informed consent, and are seen to deviate from their ethical and legal obligations, and actively make decisions that properly belong to the patients.
The application, efficacy and relevance of existing public health legislation.
(2003) Mazibuko, Sitwell Jabulani.; Reddi, Managay.; Buthelezi, Michael Celemusa.
No abstract available.
"The best interests of the child : a perspective into the refusal of necessary medical care for children, by parents, on the basis of religious beliefs."
(2014) Reddy, Pravania.; Perumal, Devina Nadarajan.
The best interests of the child is of paramount importance as indicated by our supreme law of the land, the Constitution of the Republic of South Africa. South African law creates a firm basis for the protection of children’s right. One such right is the right to receive adequate medical care and not to be refused such care for any religious reasons. Parents have the primary and legislative duty to provide the child with all needs required, including the right to health care, in order to ensure the wellbeing and best interest of the child. The “best interests of the child” standard has been one which has received extensive court intervention but application in South African law has been truncated. Parents often refuse medical care for their children based on their personal religious objections, and rather tend to opt for faith healing. Sometimes such refusal tends to harm the child rather than benefit the child. The adverse effects unreasonably placed on children by such refusal, have resulted in severe harm, damage or even death of the child. Often parents are not held accountable. The law needs to promulgate more stringent provisions creating liability on parents who neglect and harm their children. The High court acts as the upper guardian of all children and are obliged to limit parental rights in order to serve the best interests of the child. Although the courts play an active role in the child’s life, the need for intervention by third parties is looked at as a possibility. Third parties who have an interests in the child’s health and wellbeing should be allowed to make decisions regarding heath care which is in the child’s best interest. This dissertation will seek to introduce third party intervention into South African law.
A black market perspective on organ trafficking : suggestions for possibly preventing the illegal organ trade.
(2012) Doodnath, Arvitha.; McQuoid-Mason, David Jan.
No abstract available.
The clinical and human rights challenges pertaining to HIV/AIDS and TB co-infection in South Africa.
(2014) Nsanzabaganwa, Oliver.; Vawda, Yousuf Abdoola.
Prior to 1990, HIV/AIDS and TB co infection was not a major public health threat in South Africa (SA). The serious ignorance and negligence on the part of then SA government with regard to HIV/AIDS led to the increase of this disease. With the increase of the burden of HIV/AIDS and related infections such as TB, various international, regional and national stakeholders have strongly advocated that people living with HIV deserve special protection because of their vulnerability. In SA, laws, courts and the creation of the National Strategic Plan (NSP) on AIDS, STIs and TB have played an important role in the management and control of these diseases. However, the scarcity of the health care personnel, the persistence of stigma and discrimination and the lack of adequate infrastructure and information among the population continue to challenge government efforts. Similarly, the deficiency of healthcare equipment, drugs interaction and lack of patient compliance to the proposed therapy undermine health prevention and treatment measures. Therefore, research has shown clinical, ethical and legal challenges that arise from HIV/AIDS and TB co infection. Despite the international laws and guidelines and standards set by international bodies (such as the WHO and UNAIDS), the constitution of SA and various laws and government health policies for the management of these diseases, results are still mediocre in relation to government efforts, international standards and the intensity of these diseases elsewhere. Additionally, the persistent stigma and discrimination in different areas, the impact of patent rights on the availability of ARV and TB drugs and poor health care service delivery have affected the management of HIV/AIDS and TB. The dissertation was prompted by the need to make a contribution to the current body of literature on HIV/AIDS and TB co infection in SA by investigating how the management of these diseases can be improved and sustained in a way that helps to protect the rights of those people living with HIV and TB co infection. As a result of the analysis conducted, it is evident that the efficacy of the management and control of HIV and TB co infection programme also depends on the revision of patent laws to promote manufacturing of medications and materials, consolidating counselling to encourage patients, community, and healthcare workers, among others. Additionally, the increase in spending on these diseases and in human resources as well as in political commitment are essential to the management of these infections.
Commercial surrogacy in South Africa: a rights based approach.
(2020) Chivenge, Lilleonah.; Soni, Sheetal Jacqueline.; Bhamjee, Suhayfa.
Abstract available in PDF.
A comparative analysis of the legal status of cryopreserved embryos, resulting from in-vitro fertilisation, for the purpose of custody issues during divorce proceedings.
(2014) Moodley, Kamini.; McQuoid-Mason, David Jan.
The process of cryopreservation of embryos is a relatively new concept in the field of in vitro fertilisation (IVF) treatment. South African law is silent on the manner in which these cryopreserved embryos should be disposed of; in instances of divorce. During the course of this paper, comparisons will be made between South Africa and countries that have already dealt with custody disputes of these cryopreserved embryos during divorce. The United States of America (USA); Unoted Kingdom (UK) and Australia are countries that have already dealt with these issues in their courts. The analogies made between these countries and South Africa will illustrate the deficiencies in South African law. The USA, UK and Australia will also be compared with each other to demonstrate which country has the most accurate approach in dealing with these matters. To this end, cases that have been dealt with in each of the countries’ jurisdictions will be examined and critiqued. The validity of surrogacy agreeements, both under the common law and under the Children’s Act 38 of 2005 (The Children’s Act), will also be discussed. The purpose of this discussion is to comment on the similarities between surrogacy agreements, and embryo disposition agreements, and argue that laws similar (to those regulating surrogacy agreements) should be promulgated to govern and regulate embryo disposition agreements. The submission that I will make in conclusion is that in the event of not enacting legislation to specifically govern embryo disposition agreements, the legislature should amend the Children’s Act to include the regulation of embryo disposition agreements. The amendment of the Childrens Act is the most practical approach to remedy the lacuna.
A conceptual analysis that non-disclosure of HIV/AIDS status before engaging in sexual conduct is fraud.
(2019) Mhlongo, Sueng.; Mnyongani, Freddy Duncan.
No abstract available.
Conscientious objection to termination of pregnancy in South Africa: analysing the legislative framework governing the rights of patients and healthcare providers.
(2024) Ganesh, Nivida.; Soni, Sheetal.; Badul, Chantal Jacqueline.
The termination of pregnancy (TOP), underpinned by international, constitutional and statutory laws, is an essential medical service available to girls and women in South Africa. Health practitioners involved in TOP provision possess the constitutional right to conscientiously object to such services, but this can conflict with the patient’s right to access reproductive healthcare. Therefore, this doctrinal study, through an examination of relevant legal doctrines and other contextual literature, aimed to scrutinise the legislative framework governing the rights of both patients and practitioners concerning TOP and conscientious objection (CO) within the public healthcare sector in South Africa. The findings show that CO primarily relies on the objecting provider's responsibility to refer patients to an alternative and willing provider. However, when considering this duty against the grim backdrop of a dysfunctional and critically under-resourced public healthcare system, undefined or non-existent referral pathways, public health laws incongruent with socio-economic realities, and a lack of policy monitoring structures, it becomes evident that this regulatory mechanism is inadequate to safeguard the rights of the patient. Since CO has the potential to undermine health rights, and social and reproductive justice, targeted advocacy is imperative at legislative, political, social, and health system levels to establish a realistic rights equilibrium within this normative gap. This is a critical starting point in ensuring that girls and women are not unreasonably impeded in their pursuit of TOP care.
Consensual sexual offences : should we make our youth sexual offenders? A critical review of the Teddy Bear case.
(2017) Maharaj, Alisha.; Strode, Ann Elaine.
No abstract available.
Consent laws: sexual reproductive health rights for adolescents in South Africa.
(2019) Lukhele, Maamie Lesizwe.; Strode, Ann Elaine.
No abstract available.
Consent to medical treatment: To what extent does the post 1994 South African legal framework on consent protect patients: a critical review.
(2021) Bango-Rili, Nompumelelo.; Strode, Ann Elaine.
No abstract provided.
Considerations for the legal recognition of advance directives: a comparative analysis.
(2019) Shreepal, Suraksha.; Bhamjee, Suhayfa.
An advance directive1 refers to a document drafted by a person in his2 full senses and who foresees that due to some physical or mental disease, he may fall into a state where he will no longer be able to make rational decisions on his medical treatment or care3. Within this document, he purports to make requests or give orders to those who will be responsible for his medical care or treatment4 when he is rendered unable to do so himself.However, South African Law has no clear legal guidelines or any definite statutes or legislation regarding advance directives5 except for the Health Professions Council of South Africa Guidelines6 and the South African Medical Association Guidelines7. The National Health Act8 does however to some extent mention and provide for the appointment of proxies and substitute healthcare decision makers which provides for an effective way for patients to appoint another to make treatment and consent decisions on their behalf when they can no longer do so themselves There is also no specific and direct case authority at common law to provide clarity10. The only case relating to Advance Directives and which was heard in a South African Court was the case of Clarke NO v Hurst11 which influenced the introduction of the Health Professions Council of South Africa Guidelines12 and the South African Medical Association Guidelines13. The only draft legislation in relation to advance directives in South Africa is the, South African Law Commission Report Project 86: ‘Euthanasia and the Artificial Preservation of Life’14 as well as the National Amendment Bill, 2018, (Private Member’s Bill)15. The Constitution16 is the supreme law of the land and the state has a duty to ensure that all rights are not violated or infringed against, at all costs17. However, Section 36 of the Constitution18 provides for a General Limitation Clause which provides for all rights within the Bill of Rights to be limited in terms of general application and states that any limitation must however, be reasonable and justifiable made with good cause. The right to dignity19, the right to life20, the right to privacy21 and the right to security and control over one’s body22 is of vital importance in relation to advance directives. These aforementioned rights affirm the rights of individuals to refuse treatment evenif it may result in their death23. Thus, this dissertation will argue and motivate that valid refusals of treatment or procedures contained in advance directives should be honoured and further given legal credence. Notwithstanding the existence of draft legislation, advance directives has not been implemented and introduced in South Africa, hence advance directives are not legally binding documents24. The physician’s liability also remains unclear if they comply with such directives without a court granting an order.This dissertation seeks to explore the different types of advance directives and the position in South Africa. It also compares and contrasts the position to other like-minded jurisdictions. Namely, Canada and the United Kingdom (UK). Canada will be focused on largely as many provinces within Canada have implemented legislation regulating the use of advance directives and which gives legal recognition to said advance directives26. The UK will be discussed as numerous case authorities exist favouring the use of advance directives27. Important to note is that, the UK does not only have case authority which deals with advance directives and end of life decisions but also respects and honours valid refusals of treatment as long as they were made in accordance to the requirements of the relevant legislation.
Corrective rape as an anti-lesbian hate crime in South African law : a critique of the legal approach.
(2016) Hlongwane, Nondumiso Tracy.; Lotz, Lloyd Cassius.
‘Corrective’ rape as an anti-lesbian hate crime in South African Law has not received much attention from authors. ‘Corrective’ rape is a real practice in South Africa. The need for a closer analysis of the existing legislative framework is necessary to assess the need for further protection for Lesbian women against ‘corrective’ rape. However, rape in South Africa is a universal issue that does not only affect lesbian women. As this is the case, this thesis proposes the correct implementation of the legislative framework, opposed to enactment of hate crime legislation when it comes to ‘corrective’ rape, even though ‘corrective’ rape is a hate crime. Furthermore, the primary issue with ‘corrective’ rape lies in the nature of the crime, which is the crime of rape recognised and sanctioned under South African Law.
A critical analysis of exclusionary clauses in medical contracts.
(2013) Ramkaran, Tasveera.; McQuoid-Mason, David Jan.
Exclusionary clauses in South Africa have thus far been interpreted narrowly by the South African Courts. It has been accepted that where a patient enters into a medical contract/agreement with a hospital that includes a clause excluding the hospital and its employees from any form of liability whether negligently or not, the patient has no form of recourse against the hospital for any damages caused except that caused by gross negligence; the hospital will be absolved of any form of liability. The term caveat subscriptor applies – “let the signer be aware” that he/she is bound by the agreement signed by him/her whether or not it was read and understood. The leading case in South Africa dealing with exclusionary clauses in medical contracts is Afrox Healthcare Limited v Strydom. Since that decision the Consumer Protection Act has came into existence. My research question involves determining the impact an exclusionary clause would have, when analysed in terms of the provisions of the Consumer Protection Act with particular reference to its applicability and enforcement in medical/hospital contracts. The Afrox case has in itself been a controversial decision, with many legal writers of the opinion that the principles laid down by the case need to be overturned as the judgement is not in line with public policy. It is argued that with the Consumer Protection Act in place, it can be assumed that exclusionary clauses in medical/hospital will no longer be valid. The Act is a step in the right direction towards patient/consumer protection and awareness.

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