by Dr Ken Harvey, with an introduction by Ken Greatorex

To set the scene for those not familiar with the glacial machinations of Australia’s Therapeutic Goods Administration: Until recently in Australia we had a complaint process whereby if you wanted to complain about the advertising of a particular listed medicine, you submitted. to the Complaints Resolution Panel. It was woefully under resourced, but it did its job, carried out inquiries then reported established breaches in conduct to the TGA. The TGA acted – sometimes.

Then things changed. Against the urging of such groups as The Australian Skeptics, Friends of Science in Medicine, Choice and other consumer advocates, the TGA became the body which dealt directly with such complaints. 

As one who attended and absorbed the excellent review from Professor Harvey and three of his students, the result of this change has been:

• totally predictable
• disappointing

(left to right: Mal Vickers, Kithmini Cooray, Mary Malek, Ken Harvey)

Speakers:

• Mal Vickers, Analysis of old and new advertising complaint systems
• Mary Malek, TGA consultation on “low risk” products
• Kithmini Cooray, Bright Brains (Bacopa Monnieri) TGA complaint

Discussion:

The audience did not agree that the ongoing advertising of ‘Bright Brains’, illustrated by Kithmini, had achieved compliance with the Therapeutic Goods Advertising Code 2015. In short, they disagreed with the TGA outcome statement about this complaint.

Which led to an interesting discussion on the TGA’s two key performance indicators(KPIs); time to action a complaint and time to close a complaint.

If ‘low priority’ complaints are closed by merely sending an educational letter to the advertiser (usually on the same day the complaint is received) then there is no difficulty in meeting time-based KPIs.

Equally, higher priority complaints (such as Bright Brains above) can easily meet their KPIs if they are closed by stating that compliance has been achieved when it has not.  Presumably this complaint was closed by an assurance given by the advertiser, but without checking to see if compliance was actually achieved.

KPI’s can also be more easily met if no information is provided on why some alleged Code violations were  accepted but others were not.

The Department of Health has disparaged the old Complaint Resolution Panel (CRP) on the grounds that it was slow. They promised the new TGA complaint system would be faster.

The CRP sent every complaint they judged to breach the Code (broke the law) to the advertiser for a considered response. They published on their web site a full  determination on the claims alleged to breach the Code, often running into many pages.  Yes, this process took time, but the end result was transparent and educational for advertisers and complainants. Contrast this, with current TGA published complaint ‘outcomes’.

These results raise questions about the competence of TGA staff assessing complaints and/or suggest they are far too willing to accept assurance of compliance from advertisers, or minor amendments, as an easy way of closing the complaint to meet their KPIs.

This “tick and flick” approach is convenient for the TGA and industry and but it is appalling consumer protection. It also disregards the purpose of the Therapeutic Goods Advertising Code 2015 and the Therapeutic Goods Act 1989 which the TGA is meant to uphold.

The critique by Commissioner Hayes on the financial services industry and their regulators is equally applicable to the complementary medicine industry and the Therapeutic Goods Administration. 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.