I’ve begun a substack blog titled Welfare Law in Australia. The purpose of the blog is to write and compile a bunch of informal notes about welfare law in Australia, primarily in the Administrative Appeals Tribunals, as I develop my interest in this field. Please visit the substack at https://welfare.substack.com/
Although my primary interest remains in medical law, my experience in administrative law, through reviews of administrative decisions in relation to medical and other health practitioners, means that this work, dealing with the Administrative Appeals Act 1975 (Cth), is still familiar and relevant.
Although no clear cases of liability have arisen in Australia, it’s not difficult to imagine these advertisements causing harm. In a period already witness to anxious consumer behaviour, a spell of pharmaceutical panic-buying might just be too predictable.
The administrative body responsible for controlling drug advertising in Australia is the Therapeutic Goods Administration (TGA). The TGA wields considerable regulatory power to ensure no individual or company promotes unproven therapeutic goods to the public.
In recent months, the TGA has used its powers rather vigilantly. But unlike the newly-crafted emergency orders declared in our states and territories, the TGA’s swift and strict response comes from pre-existing levers.
The TGA’s Regulatory Clout
The TGA’s ability to act against “restricted” and “prohibited” advertisements emanates from legal amendments made as long ago as 2003.
But more recent changes have enhanced the TGA’s powers.
In many ways, COVID-19 has been the first real test of this greater regulatory clout.
Communication over Complication
But the TGA is a complicated organisation with complicated rules.
After years of incremental tinkering, the therapeutic goods legislation is diffuse and intricate. If this legal complexity alienates consumers at the best of times, it must bewilder during a global pandemic.
Publishing an advertisement likely to result in harm was now an aggravated criminal offence, punishable by a jail term of up to five years and a fine of up to $A888,000 (or both). Civil penalties for non-compliant advertising could incur fines of more than $A1.1 million for individuals or $A11.1 million for body corporates.
Given the quantum of these maximum penalties, it’s arguable that the actually-issued infringements have been minor.
In June, a Sydney-based chemical company was fined $A63,000 for unlawfully advertising a medicine known as RibaMin. On its website, the ingestible tablet was described as a “low-cost effective treatment for the devastating COVID-19 virus (and possibly other related viruses or mutations)“.
It was the lone ‘pharmaceutical’ amid a host of maintenance chemicals, including concrete polishing and graffiti control products.
Though the pandemic has tested all levels of Australia’s healthcare system, it has been a special test for the TGA.
From all appearances, the TGA has been more vigilant than ever in policing non-compliant advertising during the COVID-19 pandemic. However, it’s possible some non-compliant advertising has slipped through the cracks.
In early April, the US Federal Drugs Administration (FDA) wrote to a Perth-based company promoting herbal remedies to animals, including COVID-19 treatments.
The FDA warned the company that it had violated US law by making its products available for purchase by US citizens.
But it seems no infringements were issued to the company by the TGA, possibly due to a regulatory exception that excludes homeopathic practitioners from the regulatory regime, or because the goods were not advertised for human use.
Moreover, the TGA has been criticised for not imposing more stringent penalties during the COVID-19 period.
As one critic noted, the fine imposed on Pete Evans’ company for advertising the “energy revitalization platform” is less than the cost of just two of those unapproved devices.
Time will inevitably reveal whether the TGA has responded adequately to the unlawful advertising of unapproved products during COVID-19. What’s clear, however, is that the TGA has never been better equipped to control false cures than now.
Narcyz Ghinea, Megan Munsie, Christopher Rudge and Cameron Stewart, ‘Australian Regulation of Autologous Human Cell and Tissue Products: Implications for Commercial Stem Cell Clinics’ (2020) 15(2) Regenerative Medicine 1361–1369. doi: 10.2217/rme-2019-0124.
Cameron Stewart, Ian Kerridge, Catherine Waldby, Wendy Lipworth, Megan Munsie, Tamra Lysaght, Christopher Rudge, Narcyz Ghinea, Lisa Eckstein, Jane Neilsen, Jenny Kaldor and Dianne Nicol, ‘Unconventional Practice, “Innovative” Interventions and the National Law’ (2020) 27 Journal of Law and Medicine 574–589.
Wendy Lipworth, Miriam Wiersma, Narcyz Ghinea, Tereza Hendl, Ian Kerridge, Tamra Lysaght, Megan Munsie, Christopher Rudge, Cameron Stewart, Catherine Waldby, ‘The Oversight of Clinical Innovation in a Medical Marketplace’ in Graeme Laurie (ed), Cambridge Handbook of Health Research Regulation (Cambridge: Cambridge University Press, 2020) (forthcoming).