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A comparative analysis of the regulatory framework of the therapeutic application of stem cell technologies
Dissertation (LLM)--University of Pretoria, 2017.
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| Format: | Thesis |
| Language: | English |
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University of Pretoria
2017
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| _version_ | 1867613548821086208 |
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| access_status_str | Open Access |
| author2 | Carstens, Pieter Albert, 1960- |
| author_browse | Carstens, Pieter Albert, 1960- |
| author_facet | Carstens, Pieter Albert, 1960- |
| collection | Thesis |
| dc_rights_str_mv | © 2017 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. |
| description | Dissertation (LLM)--University of Pretoria, 2017. |
| format | Thesis |
| id | oai:repository.up.ac.za:2263/62543 |
| institution | University of Pretoria (South Africa) |
| language | English |
| last_indexed | 2026-06-10T12:37:54.123Z |
| license_str | Other — see source repository |
| provenance_str_mv | Harvested via OAI-PMH from UPSpace — University of Pretoria Institutional Repository |
| publishDate | 2017 |
| publishDateRange | 2017 |
| publishDateSort | 2017 |
| publisher | University of Pretoria |
| publisherStr | University of Pretoria |
| record_format | dspace |
| source_str | UPSpace — University of Pretoria Institutional Repository |
| spelling | oai:repository.up.ac.za:2263/62543 A comparative analysis of the regulatory framework of the therapeutic application of stem cell technologies Carstens, Pieter Albert, 1960- timmie.laurens@gmail.com Laurens, Johannes Bernardus UCTD Regenerative Medicine Stem Cell Regulation National Health Act Human Tissue Authority Dissertation (LLM)--University of Pretoria, 2017. 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. Public Law LLM Unrestricted 2017-09-29T07:14:04Z 2017-09-29T07:14:04Z 2017-09-06 2017 Dissertation Laurens, JB 2017, A comparative analysis of the regulatory framework of the therapeutic application of stem cell technologies, LLM Dissertation, University of Pretoria, Pretoria, viewed yymmdd <http://hdl.handle.net/2263/62543> S2017 http://hdl.handle.net/2263/62543 en © 2017 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. application/pdf University of Pretoria |
| spellingShingle | UCTD Regenerative Medicine Stem Cell Regulation National Health Act Human Tissue Authority A comparative analysis of the regulatory framework of the therapeutic application of stem cell technologies |
| title | A comparative analysis of the regulatory framework of the therapeutic application of stem cell technologies |
| title_full | A comparative analysis of the regulatory framework of the therapeutic application of stem cell technologies |
| title_fullStr | A comparative analysis of the regulatory framework of the therapeutic application of stem cell technologies |
| title_full_unstemmed | A comparative analysis of the regulatory framework of the therapeutic application of stem cell technologies |
| title_short | A comparative analysis of the regulatory framework of the therapeutic application of stem cell technologies |
| title_sort | comparative analysis of the regulatory framework of the therapeutic application of stem cell technologies |
| topic | UCTD Regenerative Medicine Stem Cell Regulation National Health Act Human Tissue Authority |
| url | http://hdl.handle.net/2263/62543 |