Advertising complaints and the TGA: Too many cowboys (not enough sheriffs)
In the first of a two-part investigation, Rhys Cohen analyses the TGA’s handling of medicinal cannabis advertising complaints and explains why the body is struggling to keep up. Since 2018, the Therapeutic Goods Administration (TGA) has received more than 450 complaints regarding advertising of medicinal cannabis. As of September 21, 2020, only 202 of those cases had been resolved.
Not only that, but of a sample of 96 medicinal cannabis advertising complaints completed since 2018, the TGA missed their time-to-action performance target in more than 50% of cases (more on that shortly).
The issue of advertising and medicinal cannabis in Australia is confusing and dynamic. And it is hard to get a clear picture of how advertising guidelines are being interpreted and what this all means for the industry.
So make a cup of tea, settle in, and let’s get started.
Advertising medicinal cannabis to the public
According to the TGA guidelines, advertising or promoting the use of medicinal cannabis to the public is not permitted.
Some advertising cases are very clear cut. For example, product companies must not have names and pictures of their products on their publicly-facing websites, press releases, ASX announcements, social media, blogs etc.
The guidelines also restrict the promotion of classes of restricted drugs (such as benzodiazepines and cannabinoids), not just specific products. So promoting ‘medicinal cannabis’ to the public, even if it’s not a specific product, is also not allowed.
Medical services may be promoted to the public in Australia, but not in a way that promotes a prescription medicine. So pain clinics are fine, but opioid clinics are not. The guidelines allow beauty salons to advertise lip fillers (medical service) but not Botox (a prescription-only medicine).
Likewise medical doctors can advertise the fact that they specialise in a certain field (such as elder care) but not that they can prescribe specific classes of products (such as opioids or cannabinoids).
But what is ‘advertising’?
To help guide the medicinal cannabis industry, the TGA has produced specific guidance about what is, and is not, permitted. According to the TGA guidelines, ‘advertising’ means:
“Any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods… the intention… is gauged..[by] what the reasonable consumer views as being intended by the content… if members of the public or health professionals would reasonably consider that the information promotes the use or supply of the identified goods, then the TGA would be likely to consider it an advertisement” (italics added).
So the line between advertising and, for example, providing educational information on the possible benefits of medicinal cannabis is not just determined by the content, presentation, and overall context of the information. It is determined by whether the TGA thinks a member of the public would reasonably think the information promotes the use of medicinal cannabis.
In some cases, such as companies advertising their products on their publicly-facing websites, there is little room for ambiguity.
But when the very definition of ‘advertising’ must be interpreted, and when each instance of alleged advertising must be considered in context, it makes it difficult to identify where to draw the line between advertising and education. So much so that even the TGA has acknowledged that “the line can sometimes be grey”.
Too many cowboys (not enough sheriffs)
The TGA has limited resources to pursue alleged advertising compliance breaches. And they take a risk-based approach to handling complaints.
When a complaint is raised with the TGA via their online portal, it is triaged and prioritised based on the seriousness of the breach, the likelihood of harm to the community, the compliance history of the organisation in question, and whether the complaint is related to a current advertising compliance priority area such as COVID-19.
Medicinal cannabis was recently added as a priority advertising compliance area due to the escalating number of complaints and (possibly, in my opinion) the generally poor levels of compliance across the sector.
Although some organisations stringently adhere to a conservative interpretation of the rules, many others continue to knowingly skirt – or outright jump over – the line of what is permitted. And this is entirely unsurprising.
For medicinal product or services companies, bringing in more web traffic and social media followers translates directly into revenue. Even the most well-intentioned companies, who want to responsibly provide accurate education and balanced knowledge about medicinal cannabis, are (being companies) primarily motivated by the pursuit of profit.
And if their competitors are bending the rules to get ahead of the pack, complying with advertising guidelines puts them at a disadvantage. The only downside of breaking the rules is the threat of the TGA taking regulatory action.
And, based on the several obvious and ongoing breaches across the sector, and the TGA’s own advertising compliance data, it is not yet clear to me that violations carry much of a threat.
If you see something, say something
There are many charlatans and con artists out there who prey on ignorant and vulnerable people to make a buck. And the TGA does an outstanding job of protecting the public health of Australians from these people.
Since COVID-19, it’s amazing the TGA has had time to handle anything else, given their budgetary constraints. And that is, unfortunately, what it usually comes down to: not just whether or not something is allowed, but how much money the Government is prepared to stump up to enforce the rules.
With medicinal cannabis, the TGA has been calling on industry to dob each other in. But when the rubber hits the road and a complaint is made, how long does it take the TGA to respond? And how quickly are these complaints resolved?
First, some quick terminology – when a complaint is generated, the first thing the TGA must do is categorise the risk level of the complaint, determine the course of action, and make initial engagement with the advertiser. As soon as that engagement is made, it is considered ‘actioned’. Once no further action by the TGA is required (usually after the advertiser removes/amends the offending material) it is considered ‘closed’ or ‘completed’.
The complaints I am about to reference can all be found on the TGA website. Consider this one (reference no. CC-KOO5XVJY/2019*) made about advertising by a company, reported to the TGA on August 16, 2019. The complaint was triaged and categorised as medium risk. The TGA aims to action 95% of medium risk complaints within 40 days.
The TGA first actioned this complaint on October 10, 2020 – 430 days later.
In this case, the advertisement was still present on the company’s website and social media pages. But when the TGA finally sent the advertiser a cease and desist letter, the advertisement was removed seven days later.
In some cases, it can be tricky to make an initial engagement with the advertiser. In this case, the advertiser has an active Instagram account and website with a publicly available email address.
From the information available, it appears the advertiser was quick to comply with TGA directions. It seems likely that, had the TGA actioned this complaint sooner, the offending material would not have been publicly accessible for well over a year.
Another example is a complaint raised with the TGA on August 14, 2019 (reference no. CC-S6LYU9WC/2019*) about advertising on a website, also rated as medium risk.
Some 329 days later, the TGA first attempted to action the complaint, only to find the offending website was no longer active. The case was closed with no action taken.
The TGA produces an annual report detailing their advertising compliance activities. The most recent report, unsurprisingly, features medicinal cannabis.
As an example of their compliance activities, the TGA included a case study of a medical clinic engaged in the advertising of medicinal cannabis in violation of the guidelines. The TGA received a complaint on October 28, 2018 (reference no. CC-0GE6XM1R/2018*), issued the clinic with a cease and desist letter, and compliance was achieved.
But what is missing from this account is that it took the TGA 611 days to action the complaint.
Within seven days of actioning the complaint, the clinic had removed the advertisement and compliance was achieved.
The advertiser in question is a bricks-and-mortar medical clinic with a physical address, phone number and email address on their website. It is highly likely that they were easily contactable.
This is the case study the TGA chose to include in their own report.
You might have noticed an abundance of conditional language in this piece. And unfortunately we must take all of these numbers and examples with a heavy pinch of salt. It is surprisingly difficult to get an accurate picture of what really goes into managing advertising compliance, the sequence of actions the TGA must take, and what goes on behind the scenes.
This article was written by Rhys Cohen and originally appeared on www.cannabiz.com.au