Stem cell technologies as a branch of regenerative medicine are becoming increasingly popular as the science behind it evolves. Therefore, it is important that the regulatory framework pertaining to stem cell technologies be well defined and appropriate to prevent unethical and unscrupulous behaviour on the part of medical practitioners, which gives rise to stem cell tourism. South African legislation pertaining to stem cell technology is regarded as inadequate and dissonant with the Constitution, exacerbating the problem of stem cell tourism and denying patients access to certain stem cell therapies, which ultimately can be viewed as an infringement of their constitutional rights. The United Kingdom (UK) provides a clear-cut regulatory framework, which is not only centred around consent and patient safety but is also conducive to production of stem cell therapies. For such reasons, this dissertation finds the UK framework to be an appropriate benchmark against which the South African regulatory framework can be evaluated. By means of comparison and elaborating on the biology of stem cells in addition to pertinent ethical principles, legislation and human rights of both South Africa and the UK, an argument will be made out that South African legislation pertaining to stem cell therapy and related matters is wanting. Furthermore, analysis will be made of the definition of biological medicine as put forward by the Medicines and Related Substances Control Act 101 of 1965 to conclude that certain stem cell therapies are best excluded from such a definition as such stringent requirements and protocols encumbers access to stem cell therapies and inflates costs. Lastly, remedial measures are proposed to remedy these injustices by proposing for the institution of a specialist adivisary committee to oversee stem cell and related activities. Key Words: Regenerative Medicine; Stem Cells; Stem Cell Regulation; National Health Act; Medicines and Related Substances Control Act; Advanced Therapy Medicinal Product; Human Tissue Authority; Human Fertilisation and Embryology Authority; HTA; HFEA; Medicine and Healthcare Products Regulatory Agency; MHRA; European Medicines Agency; Tissue-engineered Products; Doctor-Patient Relationship; Medical Innovation Bill 2014; Experimental Treatments; Innovative Therapy; Hospital Exemption; Informed Consent; Special Exemption; Autologous Stem Cell Therapy; Stem Cell Transplants; Gene Therapy Advisory Committee. / Dissertation (LLM)--University of Pretoria, 2017. / Public Law / LLM / Unrestricted

This thesis is concerned with determining whether South African mental health law and its application in practice is in need of reform. In order to reach its objectives, the thesis measures mental health legislation and criminal law that affect the mentally ill individual or offender against international and local human rights standards, and generally accepted principles and scientific principles applicable in the mental health profession. Particular focus is placed on the admission of a mentally ill person as a voluntary, assisted or involuntary mental health care user, State Patient or mentally disordered prisoner in terms of the Mental Health Care Act 17 of 2002 (?MHCA?), as well a critical review of the MHCA forms used to translate the Act?s provisions into practice. The thesis critically discusses the regulation of mental health care practitioners in terms of the Health Professions Act 56 of 1974, including psychology and psychiatry and the expert witness, and the new Traditional Health Practitioners Act 22 of 2007 and its regulations. An outline of the role of the National Health Act 61 of 2003 in the administration of the health system is provided.The thesis analyses the manners in which mental health affects criminal liability, and Chapter 13 of the Criminal Procedure Act 51 of 1977. Finally a desktop study into the current state of mental health care provision and the implementation of legislation in practice is conducted, followed by conclusions and recommendations for reform to legislation, policy, and the MHCA forms where anomalies have been identified. / Thesis (LLD)--University of Pretoria, 2016. / Public Law / LLD / Unrestricted

<p>In South Africa, governance structures in the form of clinic committees, hospital boards and district health councils are intended to provide expression to the principle of community participation at a local and district level. They are meant to act as a link between communities and health services and to provide a conduit for the health needs and aspirations of the community to be represented at various local, districts, provincial and national levels. This study aimed to assess the functioning of health governance structures in the form of clinic committees. Specifically, the study sought to ascertain the number of clinic committees associated with public health facilities in three provinces in South Africa namely the Eastern Cape, Free State and KwaZulu Natal and to identify the factors that are perceived by clinic committee members to either facilitate or impede the effective functioning of clinic committees.</p>

<p>In South Africa, governance structures in the form of clinic committees, hospital boards and district health councils are intended to provide expression to the principle of community participation at a local and district level. They are meant to act as a link between communities and health services and to provide a conduit for the health needs and aspirations of the community to be represented at various local, districts, provincial and national levels. This study aimed to assess the functioning of health governance structures in the form of clinic committees. Specifically, the study sought to ascertain the number of clinic committees associated with public health facilities in three provinces in South Africa namely the Eastern Cape, Free State and KwaZulu Natal and to identify the factors that are perceived by clinic committee members to either facilitate or impede the effective functioning of clinic committees.</p>

The aim of this dissertation is an analysis of the regulatory framework for the procurement and distribution of stem cells in South Africa. This research includes aspects of the law of obligations, medical law and human rights law as found in the Bill of Rights. More specifically however, this dissertation attempts to bring to attention the shortcomings of chapter 8 of the National Health Act. An examination is undertaken according to the multilayered approach and therefore the proposed regulatory framework is examined within a constitutional framework, an ethical framework, the framework as established by common law, in this case the doctrine of informed consent and lastly within the national legislation framework as found in the National Health Act of 2003 and the regulations made in terms of the Act. This dissertation further entails a brief comparative study of the regulatory mechanisms of the United Kingdom as entrenched in the Human Fertilisation and Embryology Act of 2008 and the Human Tissue Act of 2004 and as practiced by the Human Fertilisation and Embryology Authority and the Human Tissue Authority. The analysis in this dissertation firstly provides an overview of the clinical manifestations and science of stem cell technology. Secondly, the impact of the Constitution of the Republic of South Africa is discussed with particular reference to the Bill of Rights on stem cell research and therapy. The most noteworthy conclusion to be made in this regard is that the embryo is not the bearer of constitutional rights. The ethical guidelines which act as regulatory tools in this field are then discussed with attention to general ethical principles as provided for by the Health Professions Council of South Africa as well as the Medical research Council. The doctrine of informed consent further enjoys attention as it is discussed in context of medical research and key issues are addressed regarding the process of obtaining consent in context of stem cell technologies. Certain recommendations are then made pertaining to the minimum scope required for lawful consent. Lastly a critical analysis is made of chapter 8 of the National Health Act. The findings which are made here lead to further recommendations regarding the regulation of stem cells. / Dissertation (LLM)--University of Pretoria, 2011. / Public Law / unrestricted

Magister Public Health - MPH / In South Africa, governance structures in the form of clinic committees, hospital boards and district health councils are intended to provide expression to the principle of community participation at a local and district level. They are meant to act as a link between communities and health services and to provide a conduit for the health needs and aspirations of the community to be represented at various local, districts, provincial and national levels. This study aimed to assess the functioning of health governance structures in the form of clinic committees. Specifically, the study sought to ascertain the number of clinic committees associated with public health facilities in three provinces in South Africa namely the Eastern Cape, Free State and KwaZulu Natal and to identify the factors that are perceived by clinic committee members to either facilitate or impede the effective functioning of clinic committees. / South Africa