Letters
Complementary therapies
Volume 189 - Issue 1

Commercialism, choice and consumer protection: regulation of complementary medicines in Australia

Authors:  Ken J Harvey, Viola S Korczak, Loretta J Marron and David B Newgreen

Med J Aust 2008; 189 (1): 50-53. || doi: 10.5694/j.1326-5377.2008.tb01905.x
Published online: 7 July 2008
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In reply: We agree with Kotsirilos that the current listing process of the Therapeutic Goods Administration (TGA) provides some protection for consumers by ensuring that complementary medicines (CMs) are manufactured in accordance with good manufacturing practice.

The TGA claims that about 25% of new listings are assessed in detail each year for compliance with requirements, including that sponsors must hold evidence to support promotional claims made.1 However, we understand that the TGA does not assess this evidence for quality, and that literature searches are not performed to see if more recent evidence2 contradicts that submitted by the sponsor.3

In addition, sponsors can make a conservative claim at the time of listing but then make very different claims in promotional campaigns. An under-resourced, laboriously slow and largely impotent complaint system provides little disincentive to such unethical (but profitable) behaviour.

While the Medicines Australia code of conduct (for prescription medicines) still has room for improvement, we agree with Masters that it currently provides more effective sanctions for breaches (eg, fines up to $200 000) than the options currently available to the TGA. Medicines Australia also proactively monitors compliance with the code of conduct and provides useful annual reports.4

Regardless, claims for CM that cannot be substantiated by appropriate evidence are better dealt with at the time of a marketing application rather than many months after advertisements have been published and when consumers have long been misled. We also recommended that therapeutic equivalence of the product in question should also be assessed at this time; a point reiterated by Santoro and Pollard.

We support the right of consumers to choose from a variety of therapeutic modalities offered in the market place. However, good decision making requires evidence-based information about risks and benefits, regardless of whether the medicine in question requires a prescription, can be obtained over the counter or is a CM. Even if the risks of CMs are relatively low, the financial and opportunity cost for consumers can be significant.

A pragmatic compromise to delisting CMs that lack evidence of effectiveness would be an opt-in system, funded by an additional fee, that would independently evaluate the effectiveness of specific CM products. A product with reasonable evidence of effectiveness could be awarded a symbol similar to the the National Heart Foundation “red tick”. Implementing this measure, together with the disclaimer and other recommendations we made in our article,5 would assist consumer choice and provide a market advantage for the sponsors of evidence-based, ethically promoted CMs.

These proposals have received support from health professional and consumer organisations as well as sections of the CM industry. They have been put to the Parliamentary Secretary who assists the Minister for Health and Ageing.3

Authors

  • Ken J Harvey1
  • Viola S Korczak2
  • Loretta J Marron3
  • David B Newgreen4
  • 1. School of Public Health, La Trobe University, Melbourne, VIC.
  • 2. Choice (Australian Consumers' Association), Sydney, NSW.
  • 3. Brisbane, QLD.
  • 4. Melbourne, VIC.

Correspondence: k.harvey@medreach.com.au

References

View this article on Wiley Online Library