Since the Therapeutic Goods Administration (TGA) became the single body responsible for complaints about the advertising of therapeutic goods to the Australian public on 1 July 2018, sponsors of therapeutic goods have wanted greater guidance on the approach it will take to triage and handle those complaints. The TGA has now provided detailed guidance on its intended approach.
All complaints about advertising to the public will be categorised and progressed according to their risk to the public as low, medium, high or critical. A number of factors will be considered as part of that categorisation, including:
- the likelihood of harm or injury to any person;
- the impact of the advertising on the safe and appropriate use of the therapeutic goods in issue, for their intended use;
- whether the advertising has been removed or amended;
- the advertiser's previous conduct;
- the advertiser's ability or willingness to comply; and
- the advertiser's behaviour on becoming aware of the alleged non-compliance.
The isolated incident: low-risk complaints
This is intended for one-off or isolated non-compliance where the TGA has not previously engaged with the advertiser on the matter. The alleged non-compliance would not be considered serious in terms of being misleading as to the proper content, identification or use of the therapeutic goods being advertised.
In these cases, a letter will be sent to the advertiser identifying the allegations in issue and providing information and guidance to assist with compliance. No formal investigation will be undertaken, nor will a formal regulatory finding be made. Accordingly, no response is required from the advertiser. Advertisers will however still have the opportunity to dispute or discuss the information in the notice if they wish to do so; this however could mean the TGA initiates a new case, categorised as "medium", to allow further investigation.
The TGA aims to action 95% of complaints of this kind within 14 days, and complete and close 100% of cases arising from them within 20 days.
Ongoing but not serious: the medium-risk complaint
This is intended for ongoing advertising breaches or cases in which an advertiser has blatantly advertised therapeutic goods in a non-compliant manner. To fall into this category, the alleged non-compliance must not be considered serious - that is, the advertising is not likely to lead to inappropriate or excessive use of the therapeutic goods the subject of the advertisement.
In these cases, the TGA will send the advertiser a warning, whether by letter or email, as soon as possible:
- informing it of the alleged non-compliance;
- providing it with information and rectification guidance; and
- requesting a response within 14 days that outlines its compliance actions, together with a timeframe for taking them.
While advertisers will have the opportunity to dispute the allegations, a failure to respond, or a response demonstrating that the advertiser does not intend to comply, may result in escalated regulatory action or referral for criminal prosecution. If the TGA accepts that there has been no breach, or the advertiser revises its advertising to ensure compliance, the case will be closed.
The TGA aims to action 95% of complaints of this kind within 40 days, and complete and close 90% of cases arising from them within 90 days.
More urgent action: high-risk complaints
This category covers those cases involving continued alleged non-compliance in circumstances where the advertiser is aware of their obligations. These cases are more serious in nature, including for example the use of prohibited or restricted representations. It also includes advertising that is likely to impact a consumer's ability to safely or appropriately use the therapeutic goods being advertised in accordance with their intended use.
In high category cases, the TGA will telephone the advertiser and request that it address the issues in question immediately, and provide evidence of compliance with the requested actions.
In these cases, depending on the advertiser's willingness to comply and the nature and extent of the alleged contraventions, the TGA may consider a range of different regulatory actions, including issuing infringement, directions, substantiation or public warning notices, an injunction, prosecution of a civil penalty provision, or even cancellation of the therapeutic good in question from the ARTG.
The TGA aims to action 95% of complaints of this kind within 20 days, and complete and close 90% of cases arising from them within 90 days.
The risk of harm or injury: critical-risk complaints
This category is intended for advertising that claims a therapeutic good treats serious or very serious conditions which generally require diagnosis by a medical practitioner and ongoing medical treatment. It includes:
- advertising directed to vulnerable or disadvantaged consumers with a risk that use may result in, or is likely to result in, harm or injury caused by reliance on the claims made or because of the indications advertised; and
- advertising that could cause harm or injury to a large group of consumers, or particular individuals - for example by undermining public health campaigns, or accepted public health messages.
As in the case of cases categorised as "high", the TGA will telephone the advertiser and ask it to address the alleged non-compliance immediately. This action will however also be confirmed via email.
Together with the range of regulatory actions identified in "high" cases, the TGA may, in the most serious cases, also refer critical cases to the Commonwealth DPP for criminal prosecution.
The TGA aims to action 100% of complaints of this kind within 10 days, and complete and close 90% of cases arising from them within 60 days.
Publishing outcomes
While details about the advertiser and therapeutic good the subject of advertising complaints categorised as "low" will not be published, details of upheld complaints in "medium", "high" or "critical" cases will be published on the TGA website.
Penalties for non-compliant advertising
Repeated reference is made to the possible imposition of pecuniary penalties. By reason of the reforms to the Therapeutic Goods Act 1989 (Cth) the penalties for non-compliant advertising can, in the worst-case scenario, be up to $10.5 million for a body corporate for each proven contravention.
Therapeutic goods advertising: not just compliance, but complaints response too
Sponsors should review the TGA's guidance carefully and consider whether they have appropriate policies and practices to ensure not only that their advertising is compliant, but also that they can engage promptly with the TGA in a manner conducive to the resolution of any alleged non-compliance in accordance with the TGA's stated practice.
If you have any questions in respect of the TGA's guidance, or would like advice on the advertising of therapeutic goods or dealing with complaints about the advertising of therapeutic goods, please contact us.
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