Complementary medicines advertising policy Part I: unethical conduct in the Australian market before July 2018.

Objective This study assessed the effects of complementary medicines advertising policy before major changes in 2018. Methods The study consisted of an analysis of Complaints Resolution Panel determinations from 1999 to 2018, Therapeutic Goods Administration (TGA) post-marketing surveillance data of listed products from 2014 to 2018 and a 2018 consumer survey. Results Over 1999-2018, one company, Pharmacare Laboratories (with its acquisition, Cat Media), repeatedly breached the Therapeutic Goods Advertising Code at a level threefold higher than that of any other company. Determinations of the Panel were ineffective at reducing code breaches. When the Panel referred problems to the TGA, usually no action resulted. Over 2014-18, on average there were 763 breaches of the Therapeutic Goods Advertising Code per year, most commonly because claims were misleading, unverifiable or exaggerated efficacy. Over the same period, TGA post-marketing surveillance reviewed, on average, 289 listed products each year; 77% were found to be non-compliant, primarily because of an inability to substantiate the claims made. Only 15% of 684 knowledgeable consumers surveyed agreed that complementary medicines were appropriately regulated. Conclusions Numerous complementary medicines (and medical devices) that were extensively advertised failed to meet real health needs, diverted consumers from more evidence-based treatment and wasted their money. The laws to protect consumers were adequate: the problem was lack of enforcement. What is known about the topic? The previous co-regulatory system for complementary medicines has been the subject of long-standing criticism; however, definitive data about the problems were largely unanalysed or disregarded. What does this paper add? This is the first analysis of the Complaints Resolution Panel's determinations over its entire life (1999-June 2018). The paper provides a baseline from which the outcomes of the new complaint system (after July 2018) can be assessed. At that time, the Panel was abolished and the TGA took over the complaint system, with enhanced investigative and enforcement powers. The analysis shows that most complaints received were upheld by the Panel and a small number of sponsors repeatedly breached the Code. TGA post-marketing data from 2014 to 2018 revealed a high level of regulatory non-compliance by listed products, and a 2018 consumer survey showed low levels of trust in the regulatory system. What are the implications for practitioners? The failure of the TGA to ensure regulatory compliance by advertisers of complementary medicines (and medical devices) meant that health practitioners and consumers were unlikely to recognise the extent of misleading and deceptive claims in the marketplace. Practitioners rarely have the time or resources to investigate claims themselves. The consequence is that consumers will waste their money on useless products and be diverted from seeking more evidence-based remedies. It remains to be seen whether the new regulatory system will address these problems.