Title page for ETD etd-07122011-115208

Document Type Master's Dissertation
Author Prinsen, Larisse
Email larisse.prinsen@up.ac.za
URN etd-07122011-115208
Document Title An analysis of the proposed regulatory framework for the procurement and distribution of stem cells
Degree LLM
Department Public Law
Advisor Name Title
Prof P A Carstens Supervisor
  • embryo
  • medical and scientific experimentation
  • ethical guidelines
  • informed consent
  • National Health Act of 2003
  • regulatory framework
  • induced pluripotent stem cells
  • dignity
  • regulations
  • life
  • stem cells
  • constitutional rights
  • cloning
Date 2011-04-11
Availability unrestricted
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.

2010, University of Pretoria. All rights reserved. The copyright in this work vests in the University of Pretoria. No part of this work may be reproduced or transmitted in any form or by any means, without the prior written permission of the University of Pretoria.

Please cite as follows:

Prinsen, L 2010, An analysis of the proposed regulatory framework for the procurement and distribution of stem cells, LLM dissertation, University of Pretoria, Pretoria, viewed yymmdd < http://upetd.up.ac.za/thesis/available/etd-07122011-115208/ >


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