TGA Infringement Notices on a Vertiginous Rise
It’s probably apparent to most of us right now that disaster brings out both the best and the worst in humankind.
Take heart in the incredible acts of kindness reported daily as we recognise the sacrifices and risks that so many healthcare professionals, supermarket workers and delivery drivers are taking to keep the rest of us safe and as comfortable as is possible.
And meanwhile, others look upon the death of approaching half million people worldwide as opportunity to make money. And this trend has become evident in the rising number of infringement notices for advertising of therapeutic products being issued by the TGA.
The TGA first took sole responsibility for handling complaints about advertising of therapeutics goods in Australia on 1st July 2018. They issued their first annual report on therapeutic goods advertising compliance the following year, detailing 1468 complaints which generated 2,436 cases (since a ‘case’ is raised per breach of the code*, not per complaint). During this reporting period the TGA report only 3 infringement notices to 2 entities.
*Therapeutic Goods Advertising Code (No.2) 2018 made under subsection 42BAA(1) of the Therapeutic Goods Act 1989. It came into effect on 01 January 2019 and was updated on 30 July 2019. The underlying advertising principles have not changed but provide clarity on the requirements. The TGA conducted industry training events to assist with the change. During the transition period between the old and the new, some discretion regards compliance was given by the TGA.
But recently there has been a spate of activity from the TGA’s Regulatory Education and Compliance Branch; in the last 3 months they have issued 17 fines against a total 111 infringement notices for failure to comply with the code.
Oddly, this vertiginous increase does not seem to be backed by a proportionate rise in the number of cases raised, meaning that complaints are currently more likely to end with the TGA taking action than before.
So why have the number of infringement notices issued per case raised increased so dramatically? Details of the cases make it sadly obvious:
| Date | Company | Charge | Fine |
|---|---|---|---|
| 30-Jun-20 | Available on TGA Website | Two infringement notices for unlawful advertising of test kits and masks relating to COVID-19 | $25,200 |
| 30-Jun-20 | Available on TGA Website | One infringement notice for unlawful advertising relating to COVID-19 | $12,600 |
| 29-Jun-20 | Available on TGA Website | Two infringement notices for manufacturing/suppling hand sanitisers not entered in the ARTG | $25,200 |
| 29-Jun-20 | Available on TGA Website | Three notices for unlawful advertising relating to COVID-19 | $7,560 |
| 17-Jun-20 | Available on TGA Website | Two infringement notices for the unlawful importation of cosmetic medical devices | $25,200 |
| 18-Jun-20 | Available on TGA Website | Twelve infringement notices for unlawful advertisement of prescription only goods | $30,240 |
| 18-Jun-20 | Available on TGA Website | Seventeen infringement notices, including including advertising of prescription only goods | $214,200 |
| 17-Jun-20 | Available on TGA Website | Five infringement notices, including unlawful advertising relating to COVID-19 For advertising a product not listed on the ARTG for the effective treatment of COVID-19. Implied that the product was 'safe' and endorsed by the FDA. Inadequately labelled - ingredients not listed | $63,000 |
| 16-Jun-20 | Available on TGA Website | Four notices for advertising devices for treatment of COVID-19 that were not listed on ARTG | $50,400 |
| 28-May-20 | Available on TGA Website | Four notices for unlawful advertising of unapproved medicines | $50,400 |
| 22-May-20 | Available on TGA Website | One notice for unlawful advertising of a COVID-19 detection kits | $12,600 |
| 21-May-20 | Available on TGA Website | One notices for unlawful advertising of therapeutic goods in relation to COVID-19 | $37,800 |
| 13-May-20 | Available on TGA Website | Twelves notices for unlawful advertising, relating to COVID-19 | $151,200 |
| 7-May-20 | Available on TGA Website | Five notices for breaching advertising rules, relating to a COVID-19 test kit | $63,000 |
| 7-May-20 | Available on TGA Website | Notice for importing COVID-19 test kits not listed on the ARTG | Not stated |
| 24-Apr-20 | Available on TGA Website | Two notices for unlawful advertising for restricted representations relating to COVID-19 | $25,200 |
| 24-Apr-20 | Available on TGA Website | Notice for importing COVID-19 test kits not listed on the ARTG | Not stated |
| 24-Apr-20 | Available on TGA Website | Notice for advertising COVID-19 test kits | $12,600 |
| 24-Apr-20 | Available on TGA Website | Two notices for importing COVID-19 test kits not on the ARTG and for falsification in an application to the ARTG | $25,200 |
| 3-Apr-20 | Available on TGA Website | Twenty-four notices for unlawful advertising of restricted representations for goods not on the ARTG | $302,400 |
| 27-Mar-20 | Available on TGA Website | Five notices for advertising products not listed on the ARTG relating to treatment of COVID-19 | $63,000 |
The above documents all the fines brought in the last 3 months. Whilst the other infringements are significant and numerous, of these 21, FIFTEEN RELATE TO COVID-19. Particularly alarming is the case raised for medicines containing the hydrogen peroxide for internal use, and another containing sodium chlorite for which the TGA raised public safety alert due to the health risk.
This trend did not go unnoticed by the TGA and they were again prompted to issue a warning about illegal advertising relating to COVID-19 which highlighted the punishment of “up to 5 years’ imprisonment and … fines of up to $840,000 for an individual or $4.2 million for a body corporate” and other civil penalties. The first warning was published on 7th February 2020. That entrepreneurial spirit was certainly quick off the mark …
There are a couple of key themes obvious in the above.
- Importation of items not listed on the Australian Register of Therapeutic Goods (ARTG)
- Advertising therapeutics goods not listed on the ARTG
All products deemed a ‘therapeutic good’ must be listed on the ARTG (except under specific exemptions) to permit their sale in Australia.
Particularly for imports, this system is in place to ensure that all medicines, medical devices, diagnostics etc produced internationally are manufactured to the standards of safety, efficacy and quality required by the Australian market.
Help to determine if a product falls into the category is provided by the TGA’s very useful “Is my product a therapeutic good?” tool
- Unlawful advertising
- Advertising therapeutics goods with restricted representations
Restrictions and controls around the advertising of therapeutic goods are in place to protect the wellbeing of potential consumers, and specifically prohibit the advertisement of prescription only drugs.
“Advertisers must meet to ensure the marketing and advertising of their therapeutic goods is:
- conducted in a manner that promotes the quality use of the product
- socially responsible
- doesn’t mislead or deceive the consumer”
Source: TGA – Advertising Code and guidance
Under the Therapeutic Goods Act 1989 (the Act), any claims or references to treating COVID-19 (and related terms) have been deemed restricted representations and as such require specific permission from the Department of Health to reference the representation in advertising material (including labelling).
One could argue that some of these misdemeanors are based in ignorance and further education programs are the answer. For those whose perpetrators intentionally deceived, falsified and collaborated to make money during this pandemic, keep your eyes open. If you are concerned about the source or representation of a therapeutic good, please contact the TGA to make a complaint.