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Pharmaceuticals and Prescribing

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

Ken J Harvey, Viola S Korczak, Loretta J Marron and David B Newgreen
MJA 2008; 188 (1): 21-25
Abstract
  • Controls on the supply and promotion of complementary medicines in Australia are weak.

  • We used weight-loss products as an example to compare the regulation in Australia of listed complementary medicines and registered pharmaceutical products.

  • Complementary medicines are listed without evaluation for efficacy, while conventional pharmaceutical products are registered after evaluation for quality, safety and efficacy.

  • From 1996 to 2006, over 1000 “weight-loss” products were listed on the Australian Register of Therapeutic Goods; most contained multiple unevaluated ingredients (herbs, vitamins, minerals) of dubious efficacy. Over the same period, 10 conventional medicines were registered; each contained one evaluated ingredient of proven efficacy.

  • The number of listed weight-loss products (and complaints about their promotion) is increasing. These appear to be a direct consequence of the decision not to evaluate listed products for efficacy and the lower fees for listing a product, compared with registration.

  • Complaint procedures (now overloaded) are no substitute for adequate regulation at the time of market entry.

  • Regulatory reform of listed and homoeopathic products is required.

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©The Medical Journal of Australia 2008 www.mja.com.au PRINT ISSN: 0025-729X ONLINE ISSN: 1326-5377