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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Date
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.
Description
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.