19 October 2020

Numbercrunching about the Australian complementary medicines advertising regime

'Complementary medicines advertising policy - Part II: unethical conduct in the Australian market after July 2018' by Ken Harvey, Malcolm Vickers and myself in (2020) Australian Health Review assesses the effects of Australian complementary medicines advertising policy after major changes in 2018. These included a legally enforceable advertising code, stronger investigative and compliance powers for the Therapeutic Goods Administration (TGA) and enhanced educational resources for industry. 

The authors analysed the TGA complaint outcome database from 1 July 2018 to 30 June 2019 and the new regulatory measures.The results were that of 1821 complaint records analysed, 92% were classified as low priority and closed by sending the advertiser a Regulatory Obligation letter. For low priority complaints, no details of the product, advertiser or alleged Code violation were published, and no follow-up was undertaken. Of 121 higher priority complaints, 79% failed to meet their key performance indicator (KPI) time to closure (60–90 days). These included complaints about dangerous sports supplements and ineffective weight loss and hangover products, some of which had been submitted in July 2018. 

Our conclusions were 

Complaint classification and actions taken by the TGA were inconsistent. 

The TGA’s new compliance powers were rarely applied. 

The new complaint system is less transparent than the one it replaced. 

There is a high rate of advertising complaints and a low rate of effective regulatory response. 

Time-based KPIs should be based on outcome measures, not when a case is closed by a process measure. 

An urgent review of the new system is required. 

Comment on Australia’s 2018 Royal Commission into Misconduct in Banking is equally applicable to the TGA: ‘Essentially a failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that.’ It also encourages others to break the law, leading to a race to the bottom and consumer detriment.

'Complementary medicines advertising policy Part I: unethical conduct in the Australian market before July 2018' by Malcolm Vickers and Ken Harvey in (2020)  Australian Health Review assessed the effects of complementary medicines advertising policy before major changes in 2018. 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. 

The authors comment 

 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. 

Their conclusions are that

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.