ASMI’s Position on the Listing System

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Thursday, 5 June 2008

The regulation of complementary medicines, particularly the listing system, has been the subject of negative publicity with allegations that consumers are being misled because there is little or no scientific evidence for product claims and indications. It has been suggested that the TGA should undertake full efficacy evaluation of all listable medicines at market entry level, as is the case with registerable medicines.

After extensive consultation with ASMI members and following discussions with Senator the Hon. Jan McLucas, Parliamentary Secretary to the Minister for Health and Ageing, the TGA and CHC, ASMI handed a submission to Senator McLucas on Friday 30 May 2008.

In its submission ASMI argued strongly that, from a risk management perspective, the current two-tiered regulatory scheme for complementary medicines is sound and consistent with the relatively low level of risk associated with the substances in complementary medicines. However, ASMI believes that certain measures could be introduced to reassure the public and to maintain confidence in the regulatory framework.

An expert committee conducted an extensive review of complementary medicines in the Australian health system in 2003 and most of the recommendations were adopted by Government. However, implementation of several of the recommendations was put on hold with the announcement in 2007 not to proceed with the joint Australia/New Zealand regulatory agency (ANZTPA). ASMI believes that implementation of some of the recommendations should be fast tracked – these include:

  • Revision and underpinning in legislation of the Guidelines for Levels and Kinds of Evidence to Support Indications and Claims,
  • Ongoing review of the registration pathway for complementary medicines to increase uptake by sponsors,
  • Adequate dissemination of information about complementary medicines to consumers and healthcare professionals in line with the outcomes from the research currently undertaken by the National Prescribing Service,
  • Submission of the evidence summary supporting claims and indications at the time of listing, and,
    Increasing the level of targeted assessment of ‘problem’ categories, e.g. weight loss.

While ASMI argued that advertising controls should not substitute for post-market compliance activities, ASMI believes that the complaints handling mechanism should be adequately resourced to respond in a timely manner to complaints. Appropriate sanctions are also required to act as a deterrent against breaches of the Therapeutic Goods Advertising Code and repeat offences.

International developments in the area of product claims are worth noting. An article entitled “New law bans selling of products with unjustified health claims” which was published in the British Journal of Medicine (BMJ 2008; 336: 1150 24 May) reported that “..consumers in the United Kingdom are to receive stronger legal safeguards against products that claim, without any identifiable scientific evidence, to provide physical and mental health benefits such as tackling obesity or depression”. Pan-European consumer protection regulations came into effect on 26 May and is intended to cover any products which are not covered by existing medicines legislation. The article quotes a lawyer as saying: "If a trader cannot prove scientifically that the product works, this will be treated as an unfair commercial practice to the detriment of the consumer. It can cover products that claim to give you energy, improve your concentration, diminish depression, or strengthen your physical and mental wellbeing."

In the US the debate revolves around the issue whether weight loss claims should be regarded as disease, i.e. obesity claims. The Tan Sheet (April 28 2008, Vol. 16, No. 017, p. 3) reported on a petition requesting pre-market approval for supplements making weight loss claims. The petitioners supported their argument weight loss claims should be limited by claiming that consumers believe that weight loss supplements are tested and proven to be safe.