A Remedy for False Cures?

Australia’s Therapeutic Goods Administration has been more vigilant in policing advertisements for unproven COVID-19 ‘treatments’. But have some slipped through the cracks?

This article was first published on Pursuit. Read the original article. It is co-authored with Professor Megan Munsie.

Beware false COVID-19 cures.

The COVID-19 pandemic has seen the emergence of multiple dangers. The obvious public health danger is the novel coronavirus strain and the disease itself.

But a secondary threat has emerged for health consumers.

Since March, several unregistered ‘treatments’ for COVID-19 have been advertised to the public. Most are untested and unproven.

A controversial example was the Biocharger NG, a “hybrid subtle energy revitalization platform”. That product was unlawfully promoted as a COVID-19 remedy by former celebrity chef Pete Evans. Evans’ company was issued infringement notices totalling $A25,200.

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.

Following a major review, the TGA became the sole complaints handling body for drug advertising nationally in 2018. Further amendments that year gave the TGA a more punitive offence regime.

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.

The administration’s principal regulatory powers come from the Therapeutic Goods Act 1989 (Cth). But several subordinate materials, including the Therapeutic Goods Regulations 1990 (Cth), the Therapeutic Goods Advertising Code (no 2) 2018 (Cth) (or, ‘the Code’ for short) and dozens of guidance documents, supplement this primary law.

The pandemic has required the TGA to improve its communications to cut through this complexity. Now more than ever, up-to-date guidance has been crucial to reach stakeholders and consumers.

To that end, the regulator has issued several important warnings on its main website and in its specialised ‘advertising hub’.

As COVID-19 was just emerging, the TGA announced that any therapeutic goods advertisement referring to the ‘novel coronavirus’, whether explicit or implied, would be a “restricted representation”.

Although the warning did not explain the mechanics of the legislation, identifying and controlling “restricted representations” is central to the TGA’s advertising controls.

So, What Exactly is a ‘Restricted Represntation’?

The primary law defines a “restricted representation” as a representation about therapeutic goods referring to a disease, condition, ailment or defect that the Code classifies as “serious”.

Back in 2005, the Code listed a range of “serious” diseases, stopping advertisers from promoting related treatments without permission. But today, the Code provides more flexible criteria.

A ‘serious’ disease may be one that, for instance, requires practitioner-led diagnosis, testing or screening.

COVID-19 was quickly identified as a serious disease, and advertising referring to it was said to be a restricted representation. But what kinds of penalties can be imposed?

Enforcing restricted Representations

In 2018, the TGA introduced a new offence regime for unlawful advertising.

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.

Earlier in June, a Cairns-based technology company was fined $A50,4000 for advertising a large tank said to produce a purified form of molecular hydrogen as a treatment for COVID-19.

In addition to these novel products, a Melbourne-based company was fined $A12,600 for unlawfully advertising a seemingly more conventional product – a COVID-19 test kit. But as the advertisement referred to COVID-19 without TGA permission, it was a restricted representation.

Evaluating the TGA’s Response

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.