An analysis of ethical issues arising in the current governance of clinical trials for Complementary Medicines in South Africa: looking towards the future

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2017

Authors

Malesela, Ledile Mmabatho Hendricca

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Abstract

The WHO (World Health Organization) estimates that 80% of the world’s population use Complementary Medicines (CMs) as their primary source of healthcare. Similar figures have been reported in the South African population (Siegfried &Hughes, 2012: 2). The high numbers of CMs users in South Africa (S.A) raises considerable questions about how best to safeguard patient and population health, and what responsibilities the government has towards regulation of medicines and practitioners. This, in turn raises the issues of how best to assess CMs – and thus whether clinical trials are an appropriate method of assessment. The considerable difference between the systems of CMs and Allopathic Medicines raises concerns when applying clinical trial practices to CMs assessment. Clinical trials, as the gold standard for assessing medical efficacy in Allopathic Medicine, reflect specific interpretations of medicine and health. It has been noted that the key practices in clinical trials for Allopathic Medicines such as randomisation, blinding and placebo can be very difficult to adhere to when investigating CMs. Thus, the use of clinical trials to assess CMs raises a range of different concerns, from the validity of the trials to the potential harm to trial participants. There is considerable interest in S.A to improve legislation governing the widespread use of CMs. Nonetheless, the development of legislative oversight requires further consideration. In this research report, I will be critically interrogating the current legislation in S.A from an ethical perspective to identify areas requiring further attention. These issues include threats to participant well-being, threats to the efficacy of the trials, and long-term threats caused by potentially incomplete trial data. My research considers ways in which these ethical considerations can be ameliorated by directed changes to the legislation. This research report will conclude by offering a range of recommendations for improvement to the governance of CMs clinical trials in S.A. The recommendations are made to the relevant departments which are making decisions with regards to clinical trials in S.A.

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A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, in partial fulfilment of the requirements for the degree of Master of Science in Medicine in the field of Bioethics and Health Law Johannesburg, October 2017.

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