In Canberra tomorrow, I will be advising Senator Jan McLucas, parliamentary secretary to Health Minister Nicola Roxon, that she has a unique opportunity to correct an imbalance in Australia’s regulation of complementary medicines.
At the moment, the regulatory balance is tipped in favour of commercial interests, with consumer protection coming a poor second. Senator McLucas has asked the Therapeutic Goods Administration (TGA) to provide a formal response to recommendations by myself and colleagues, as outlined recently in the Medical Journal of Australia.
We documented the proliferation of complementary medicines claiming to assist “weight loss” despite the fact that the ingredients they contained lacked proof of clinical efficacy. Complementary and alternative medicines are classified by the TGA as “listed goods” and are not evaluated for efficacy. In contrast, “registered medicines” are individually evaluated by the TGA for quality, safety and efficacy before market entry.
We concluded that failure to evaluate listed products for efficacy had created a commercial opportunity for the sponsors of such products at the expense of informed consumer choice and protection. We argued that overloaded complaint procedures (and ineffectual sanctions) were no substitute for adequate regulation at the time of market entry.
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The response to our paper has been predictable. The Australian Medical Association, CHOICE (the Australia Consumer’s Association) and the president of the Pharmaceutical Society of Australia agreed with us. And the major industry associations did not. The Complementary HealthCare Council (CHC) of Australia claimed our paper was, “misleading and misrepresents the current strong regulatory system in place for complementary medicines”.
The Australian Self-Medication Industry said tightening controls over complementary medicines were not justified. However, they did agree that it, “would be appropriate at this time to focus more regulatory compliance activities on weight loss products.”
In addition, the ASMI said, “that the advertising scheme, particularly the process for complaints handling, should be adequately resourced to ensure that it is responsive and timely”.
However, a new industry group said they were prepared to “rock the boat to achieve change”. The Ethical Complementary Medicines (ECM) group wants, “the regulatory system to be changed so that the public can be told clearly whether or not there is scientific evidence to support the efficacy of a particular product”.
This is an interesting suggestion which could easily be implemented by the TGA on an opt-in basis. It would require only a modest additional fee for the TGA (or contracted independent consultants) to check the promotional claims proposed by a sponsor against evidence available in the scientific literature. The result could be categorised as “evidence of effectiveness”, “inconclusive evidence”, or “evidence of ineffectiveness”. A product assessed to have “evidence of effectiveness” would have a marketing advantage that should readily recoup the additional evaluation fee. Products judged to have “inconclusive evidence” could be recommended for NHMRC clinical trial funding.
There was no disagreement with our paper’s suggestion that the public needs better information about complementary and alternative medicines. The National Prescribing Service is ideally placed to provide this, and should be charged with collating information about what products work, side-effects and drug-drug interactions.
At our meeting tomorrow, facilitated by the consumer group CHOICE, I will be urging Senator McLucas to achieve a healthier balance between commercialism, choice and consumer protection.