Volume 189 - Issue 1
Commercialism, choice and consumer protection: regulation of complementary medicines in Australia
Author: Vicki Kotsirilos
Med J Aust 2008; 189 (1): 50-53. || doi: 10.5694/j.1326-5377.2008.tb01903.x
Published online: 7 July 2008
Published online: 7 July 2008
To the Editor: The article by Harvey et al raises important concerns about the complementary medicine (CM) industry, particularly with respect to inappropriate marketing and advertising by some sponsors.1
The role of the Therapeutic Goods Administration (TGA) in setting standards and regulation of CMs should not be taken lightly. Australia has one of the highest quality standards for CMs internationally. Many CM products in Australia are assessed by expert authorities within the Office of Complementary Medicines and the Complementary Medicines Evaluation Committee of the TGA for safety and (where appropriate) efficacy relating to claims made for products.2 This is not fully appreciated by the authors.
While many CMs may lack high-quality research to validate efficacy, this does not necessarily mean they are not clinically effective. Many clinicians and consumers find CMs to be of clinical value in improving health status. By suggesting that “the listing system should be scrapped, and CAMs [complementary and alternative medicines] . . . be assessed for efficacy and delisted if evidence is lacking” would be to deny consumers choice of treatment and potential health benefits, and lead to a “black market” or buying products from overseas which may not compare in quality. The authors fail to acknowledge that much of the drive for CM sales is actually coming from consumers through their choice of health care treatment.3 Consumers have the right to trial CMs. It is our role to ascertain safety issues and encourage clinical trials where they are lacking. For thousands of years, populations have relied on some CMs for health benefits, not having the advantage of any trials, but relying solely on traditional use. If the risk of harm to human health from the use of a CM outweighs any proven or unproven efficacy, consideration should be given to delisting the product or restricting its use. More research is required to assess safety data and efficacy for CMs.
Australia has come a long way in regulating CMs. To say the “listing system should be scrapped” does not appreciate the tremendous efforts and gains made by the TGA compared with international efforts to enforce good manufacturing practice and various methods to better safeguard consumers.
The authors do raise a valid point in saying that sponsors should provide “key evidence supporting each indication of the ARTG [Australian Register of Therapeutic Goods] . . . [which] should be publicly available on the Internet”. This may be useful for consumers and health practitioners, but requires appropriate funding to be viable. Furthermore, codes of conduct and complaints procedures for CMs, such as through the Complaints Resolution Panel, need to be strengthened, particularly with respect to breaches in the advertising code.4 To date, the Parliamentary Secretary has asked the TGA for advice on the proposals put forward by Harvey and colleagues.1,5 The government will consider its response to these proposals in the context of taking forward legislative changes that were deferred in anticipation of the establishment of an Australian New Zealand Therapeutic Products Agency (TGA advice, 28 May 2008).
Competing interests
I am an expert consultant to the TGA, serving on two committees, the Complementary Medicines Evaluation Committee and the Adverse Drug Reactions Advisory Committee. I am not involved with sponsorship and do not receive monies for any CM products. This letter reflects my personal views, which are not necessarily those of the Complementary Medicines Evaluation Committee or the TGA.
References
- Harvey KJ, Korczak VS, Marron LJ, Newgreen DB. Commercialism, choice and consumer protection: regulation of complementary medicines in Australia. Med J Aust 2008; 188: 21-25. 0_CBBBIFCC
- Therapeutic Goods Administration. Complementary Medicines Evaluation Committee (CMEC) [website]. http://www.tga.gov.au/docs/html/cmec/cmec.htm (accessed Jan 2008).
- MacLennan AH, Wilson DH, Taylor AW. The escalating cost and prevalence of alternative medicine. Prev Med 2002; 35: 166-173. 0_i1091837
- Therapeutic Goods Advertising Code Council (TGACC) [website]. http://www.tgacc.com.au/index.cfm (accessed Jan 2008).
- Cresswell A. Alternative medicines group backs curbs. The Australian 2008; 19 Jan. http://www.theaustralian.news.com.au/story/0,251 97,23068700-23289,00.html (accessed 2 Jun 2008). 0_i1091842