You are here

Advertising therapeutic goods in Australia

11 August 2021

Duration: 
21 minutes 04

In this episode, we speak with Leanne McCauley, Director of the Advertising and Compliance, Education and Policy Section at TGA about:

  • what you can and can’t do when advertising therapeutic goods
  • what constitutes an advertisement
  • what responsibilities a sponsor has when advertising product
  • how the world of social media, including hash tags and testimonials ties into advertising
  • some tips and pointers for those working in this space
  • advertising compliance, including what constitutes a breach, potential penalties and how to make a report

Host: Dr Jayne Foster

Guest: Leanne McCauley


Introduction

Welcome to the Therapeutic Goods Administration’s podcast series, SME Assist - Navigating therapeutic goods regulation. We appreciate that the regulation of therapeutic goods can be challenging to understand. Throughout this series we aim to help small to medium enterprises, researchers, start-ups, and anyone new or unfamiliar with regulation, to understand their obligations when it comes to supplying therapeutic goods in Australia.

Please note that the information provided to you throughout these podcasts is without prejudice. Is it not binding on the TGA, and you should get your own independent legal advice to ensure that all of the legislative requirements are met.

Dr Jayne Foster

Hi, I’m Jane Foster from the SME Assist team at the Therapeutic Goods Administration. Welcome to the fifth episode in our series of podcasts about navigating therapeutic goods regulation in Australia. If you haven’t already, please be sure to hit subscribe and listen to our previous episode where we discussed Australian manufacturing licenses and good manufacturing practice.

Today we are discussing the advertising of therapeutic goods in Australia. We will touch on what you can and cannot do when advertising therapeutic goods, including on social media. We’ll talk about the responsibilities sponsors have, and where to find relevant information. We’ll be talking to Leanne McCauley who is the director of our advertising section here at TGA. Welcome Leanne, it’s great to have you join us today.

Leanne McCauley       

Thanks Jayne, it’s great to be here.

Dr Jayne Foster

Leanne, it would be great if we can start by giving everyone a brief overview of therapeutic goods advertising in Australia and what that means.

Leanne McCauley       

So, the term therapeutic goods is a term that we use to describe a broad range of health products including medicines, medical devices, disinfectants, tampons and menstrual cups. They’re products that we use sometimes every day and sometimes once in a lifetime to help us stay well or to diagnose or treat heath conditions.

So, given therapeutic goods are so closely connected to our health status, they are subject to special rules. Now, most of the advertising rules the TGA administers apply to advertising to consumers. There are only a few rules that apply to advertising to health professionals, so today I’m focussing on consumer advertising.

The therapeutic goods advertising rules are set out in the Therapeutic Goods Act 1989, or the Act. This includes a requirement for advertising, to consumers, to comply with the Therapeutic Goods Advertising Code. The requirements in the Act and the Code apply to advertising in addition to the consumer protections in place under Australian Consumer Law.

The Act prohibits certain high-risk goods from being advertised to consumers, and for those goods that can be advertised, the advertising must comply with the requirements in the Act and the Code to ensure it is ethical and supports informed healthcare choices.

Dr Jayne Foster

And what about the Code? What’s contained in the Code?

Leanne McCauley       

So, the Code requirements include the need to ensure claims are substantiated by appropriate evidence before they’re used in advertising. And that advertisements as a whole are accurate, balanced and not misleading.

There are also a range of other requirements specifying what must and must not be included in ads, as well as conditions on including certain things like testimonials and endorsements.

In addition, to protect the most vulnerable people in our community, the Act requires that claims that refer to serious forms of diseases, conditions, ailments, or defects, or what we call prohibited and restricted representations, require approval from the TGA before they can be used.

Dr Jayne Foster

And what about enforcement? Does TGA play a role in enforcing these requirements?

Leanne McCauley       

Yes, the TGA is responsible for enforcing the requirements for advertising therapeutic goods in Australia, in order to protect the health and safety of Australian consumers. The Act provides us with specific sanctions that we can use to address non-compliance, and also allows us to pursue criminal or civil court action if needed. But that’s generally reserved for the most egregious cases.

So, any potential advertiser of therapeutic goods needs to be aware of the rules and have the necessary compliance processes in place to safeguard themselves against non-compliance. It pays to know there are rules, where to find them, and how to comply with them.

Dr Jayne Foster

So, what sorts of things are considered advertising?

Leanne McCauley       

It all comes down to the potential impact on consumers. The Act defines the concept of advertise and it’s quite broad.

Essentially, any statement, picture or design that promotes the use or supply of therapeutic goods is advertising. It doesn’t matter what medium it’s presented in. The content could be on radio, television, social media, other internet sites, online games, a poster in a shop window, a catalogue in your letterbox, and even the label or carton of the goods themselves. Any medium that can be used to reach consumers can potentially be advertising.

Dr Jayne Foster

So, why do we need to regulate it? Why is it important that TGA regulates advertising?

Leanne McCauley       

Therapeutic goods are really very different to other types of consumer goods, like a television or a pair of jeans. For starters, we’re only seeking out therapeutic goods when we’re worried about our health or the health of our loved ones. And sure, these worries can range in seriousness from concerns that we aren’t getting enough of a certain vitamin or mineral in our diet, through to finding something to relieve the symptoms of a chronic condition.

People can be vulnerable to advertising claims because of their particular health concerns, and they may not be able to critically evaluate whether the product is appropriate for them or the people they care for. So the Act and the Code requirements exist to prevent advertising from taking advantage of people. And to ensure that advertising provides information that’s genuinely helpful to people in considering their health options.

Also, it’s important to remember that many therapeutic goods operate by having a physiological effect on the human body. So, the decision to use one is not something that should be taken lightly, and advertising must not trivialise this. Again, the requirements exist to prevent such advertising.

Dr Jayne Foster

Yep, sure, that’s really good to know. And can all therapeutic goods be advertised?

Leanne McCauley       

No, under the Act some goods can’t be advertised to consumers. These include prescription medicines, biologicals, also known as human cells and tissues, as well as certain types of medical devices. These are products that require a doctor or other health professional to ensure they are suitable for you, and to monitor that they work as intended and for potential side effects.

Also, therapeutic goods that are being imported, manufactured or supplied illegally cannot be advertised to consumers. These are goods that are required to be included in the Australian Register of Therapeutic Goods before they’re imported, manufactured or supplied but haven’t been.

Dr Jayne Foster           

Right, so for our listeners, if they wanted information on the Australian Register of Therapeutic Goods, or the ARTG, you could listen to the first episode in our series. But Leanne, what about advertising through social media? What would be considered inappropriate advertising there?

Leanne McCauley       

So, for advertisers making social media posts about therapeutic goods, it’s really easy to forget that posts are likely to be advertising. And if they’re advertising, then they need to comply with the relevant rules. This includes making sure they include the mandatory information and required by the Code.

Dr Jayne Foster

That would include… Ah right, so that would include the comments as well?

Leanne McCauley       

That’s right, yes.

Dr Jayne Foster           

So, could you give us an example of some inappropriate advertising on social media?

Leanne McCauley       

So, let’s say the sponsor of a new over-the-counter medicine for temporary pain relief launches a website page and a Facebook page for their medicine. After some months a consumer writes a post to the Facebook page saying that the medicine has been highly effective in easing their anxiety. If that post is left in place, all consumers visiting the page can see the post and it becomes part of the overall advertisement for the medicine.

This would cause numerous breaches of the advertising rules including advertising an indication that’s not on the ARTG entry for the good, the unapproved use of a restricted representation, being anxiety, and the use of an inappropriate testimonial. So, the best thing for the sponsor to do is to delete the post as soon as possible to avoid misleading consumers and being found to be non-compliant.

Dr Jayne Foster           

Yes, wow, so that’s really important that sponsors keep a really close eye on their social media pages then?

Leanne McCauley       

Absolutely.

Dr Jayne Foster           

And how is TGA notified of potential breaches and how do we actually handle and approach these?

Leanne McCauley       

So, the TGA has an online form that consumers and other stakeholders can use to report suspected non-compliant advertising. We also get signals about potential breaches from other sources including media reports and other areas within the TGA that look at pre-market and post-market stuff.

We also do some monitoring of online advertising from time to time. Each report and signal is assessed to determine whether the matter is within our jurisdiction, and if it is we then conduct a risk assessment that takes into account the risk to the public health, safety and confidence in therapeutic goods regulation, the nature of the breach, the vulnerability of the target market, the compliance history of the advertiser, as well as their size and reach.

And also, we look at whether the matter aligns with our annual compliance priorities.

Dr Jayne Foster           

Yes, so, I imagine you take all of that into consideration when investigating a potential breach and you wouldn’t have capacity to investigate all breaches. Are there situations where we can’t investigate a breach?

Leanne McCauley       

Yes, there are. Sometimes reporters don’t give us enough information to be able to locate the advertisement in question. In those situations, it’s highly unlikely that we’ll be able to investigate further. Also, if the advertising relates to something that’s not actually a therapeutic good, for example, a food or a health service, then we can’t apply the Act, it’s outside of our jurisdiction and we won’t be able to investigate.

Dr Jayne Foster           

So, as a consumer, if I make a complaint about a product and it can’t be investigated, what happens then?

Leanne McCauley       

So, if that report relates to a matter where we don’t have jurisdiction, we will generally refer the report to the appropriate regulator. So, that might be the Australian Competition and Consumer Commission or a state health department, for example.

In some cases where it is within our jurisdiction, but our risk assessment indicates that the non-compliance does not present a risk to public health or safety, and it doesn’t undermine public confidence in how we regulate, we may decide not to investigate it. In these cases, we’ll store it in our intelligence database which is used to determine future annual compliance priorities.

And the case may eventually be selected for investigation at a later time, especially if we receive further information about the same advertiser that indicates there may be a more significant compliance issue.

Dr Jayne Foster           

Yep, sure. Well, I think most of us have heard about hashtags, what about these in advertising?

Leanne McCauley       

So, hashtags are commonly used to increase the reach of individual social media posts including promotional posts. We do consider hashtags to form part of the advertisement and therefore they need to comply with the advertising requirements. There are two aspects to consider in relation to hashtags and social media advertising.

Firstly, how the use of hashtags will direct the advertising to certain groups of consumers. And secondly, how the impact of using hashtags as part of the advertisement itself will impact on consumer take out messages. So, for example, a social media ad for a complementary medicine indicating, indicated for helping support health blood sugar, that contains the hashtag diabetes would pop up in the feed of anyone that followed that hashtag.

So, someone following the hashtag would infer that the product flagged with that hashtag may be of assistance in preventing or treating blood glucose issues associated with diabetes. So, this would present a range of issues in relation to the advertising rules, including the use of an unapproved restricted representation in the form of diabetes. There’s also the potential for consumers to infer claims from hashtags including hashtag stacking.

For example, an antioxidant complementary medicine that’s promoted with the hashtags cancer, disease prevention, amongst others, would be a breach of the code. While the body of the post does not refer to cancer and disease prevention, the hashtags are likely to catch the viewer’s eye, and they will infer that the medicine can be used for preventing cancer and other serious diseases.

Dr Jayne Foster           

So, do you have any tips Leanne, on what people should look for or look out for when it comes to advertising?

Leanne McCauley       

So, the TGA advises consumers in terms of assessing advertising and we will considering advertising that if it sounds too good to be true then it probably is. We also recommend that people look for an ARTG number or an AUST L or AUST R or an AUST L(A) number on therapeutic goods before they purchase them. This provides a level of assurance that products are listed in the Australian Register of Therapeutic Goods.

We also recommend that consumers don’t take advice from social media influencers about what supplements or medicines to take. It’s really up to your health professional or health practitioner to be informing your decisions about what medicines to take. We also recommend that you’re wary of claims relating to serious diseases and conditions, and again, to talk to a health professional if you have any serious health concerns.

Dr Jayne Foster

Thanks Leanne. And what about if I’m a sponsor, I’d like to advertise my therapeutic good, where should I start in order to find what I can and can’t advertise?

Leanne McCauley       

So, firstly, you should be familiarising yourself with the advertising rules which are set out in the Act and the Advertising Code. From here, the key hurdles that you’ll need to clear are making sure that you can lawfully advertise the good, i.e., the advertising of that particular good is not prohibited. You’ll need to assess the evidence that you hold about that good and what sort of claims it will support in advertising. And then you’ll need to establish whether those claims include any prohibited or restricted representations that will need an exemption from the TGA.

So, from there it’s all about constructing your advertising to ensure compliance with the other requirements of the Act and the code. So, for example, making sure the advertising does not conflict with the ARTG entry for the goods and avoiding the temptation to embellish advertising. It’s vital that claims about the good are commensurate with the type and strength of your supporting evidence, noting that miraculous, sure cure and those sorts of claims are prohibited, even if you have evidence that might substantiate them.

We have published a checklist on the TGA website to help advertisers ensure their ads comply with the advertising rules, although it’s not a substitute for the legislation itself.

Dr Jayne Foster           

Yes, we probably should point out that on the TGA website there’s a dedicated advertising hub where I think you can find that checklist, and it’s got lots of really good information for both consumers and sponsors. So, what about a good news story, Leanne, I’m sure there’s plenty, but can you tell of us of a time when you’ve been able to help an advertiser perhaps rectify a potential breach?

Leanne McCauley       

So, my section at the TGA is responsible for educating advertisers about the advertising rules. And we’ve assisted many advertisers over the years. One memorable example that I have comes from some advertising that we observed for a particular type of diagnostic device. The device was being promoted as being able to detect 25% more cases of a particular condition than the leading competitor.

The advertisers evidence indicated that the claim was technically correct, but the problem was the advertising failed to indicate that the incidence of this condition in the community was so low and consumers would not be knowledgeable about that incidence.

So, the claim was actually misleading about the clinical significance of the device and what it was able to achieve and diagnose. So, we were able to convey this to the advertiser and they were able to take steps to rectify the misleading claims and clarify exactly what the device was capable of doing.

Dr Jayne Foster

Yeah, excellent, I’m sure some of these breaches are really unintentional, it’s just about education and helping the sponsors to understand the requirements.

Leanne McCauley       

Absolutely.

Dr Jayne Foster           

Well, thanks Leanne, before we let you off the hook, in addition to the advertising hub on the TGA website, where else can people find out more about advertising therapeutic goods in Australia?

Leanne McCauley       

So, the advertising hub is a bit of a one stop shop, as we mentioned there’s a checklist and there’s decision trees to help you work out whether you can advertise a particular therapeutic good. There’s another decision tree that helps you identify what information you must include in an advertisement.

And there’s also, through the hub, you’ll have access to an online enquiry form that you can use to lodge questions about the application of the Act and the code. And, you know, either myself or one of my experienced team can respond to you.

However, some advertisers might decide that they need more support or a detailed audit, if you like, of their advertising in order to establish compliance. In these cases, we do recommend that advertisers seek assistance from either a regulatory affairs professional or seeks specific legal advice on the matter.

Dr Jayne Foster

Yeah, of course. Leanne, thank you very much for taking the time to speak with us today, we’ve seen so much in the media lately particularly around COVID-19, so I’m sure that this information will help people better understand how and why we regulate therapeutic goods advertising in Australia.

Thank you for joining us today, please hit subscribe in the Pod Bean app or wherever you listen to podcasts. And be sure to check out our website at www.tga.gov.au for more information on the regulation of therapeutic goods in Australia.