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Health literacy and advertising

In a spooky coincidence, 31 October heralded both Halloween and the end of health literacy month.

To support health literacy month, Seeside Advisory social media posts have focused on the role of health literacy in the advertising of medicines and medical devices. In particular, how complying with the Australian therapeutic goods advertising laws supports health literacy—especially for people with lower levels of health literacy. And now, to wrap up health literacy month (mummy style), Seeside has prepared an eerie blog post to unravel these themes further.

Key points
  • Health literacy is essential to maintaining good health and successfully engaging with health services when needed.
  • Nearly 60% of Australians have inadequate health literacy skills.
  • Health literacy can be eroded by psychological distress and chronic conditions.
  • Advertisers of medicines and medical devices have an obligation to assist their target audience to understand their advertising and assist them in making an informed choice. To do this, the advertiser needs to understand their target audience, including the audience’s health literacy capabilities.
  • Ensuring advertising complies with the Australian therapeutic goods advertising laws will help the target audience to correctly interpret and understand it.

What is health literacy?

The United States of America’s Institute for Healthcare Advancement (IHA), which brings us health literacy month, defines the concept of health literacy in two ways:

  1. Personal health literacy is how well a person can find, understand, and use information and services to make decisions about their own health and the health of others.
  2. Organizational health literacy is how well organizations equitably help all people find, understand, and use information and services to make decisions about their own health and others. 

The Australian Commission on Safety and Quality and Healthcare and the Australian Institute of Health and Welfare similarly recognise that health literacy is not solely about a person’s abilities to find, understand and use health information, recognising that the environment influences one’s health literacy and actions.

There are recognised subsets of health literacy, including mental health literacy, death literacy, digital health literacy, oral health literacy and sexual/reproductive health literacy.

Why health literacy is important

Health literacy is recognised as a key specific determinant of health, just as biological factors (like body weight and blood pressure), health behaviours (e.g., smoking, alcohol use) and socioeconomic factors are.

Health literacy can be thought of as the lens through which people view and interpret health and medical information. If the lens is coloured, patchy, thin or warped, people’s interpretations of health and medical information will be adversely affected. As such, a person’s health literacy is integral to their ability to engage with health information and access appropriate health care in a timely fashion.

The Australian Institute of Health and Welfare notes that poor health literacy is linked to poor health outcomes:

People with low health literacy are more likely to have worse health outcomes overall (Berkman et al. 2011) and adverse health behaviours, such as:
  • lower engagement with health services, including preventive services such as cancer screening (Kobayashi et al. 2014)
  • higher hospital re-admission rates (Mitchell et al. 2012)
  • poorer understanding of medication instructions (for example, non-adherence, improper usage) (Marvanova et al. 2011; Miller 2016)
  • lower ability to self-manage care (Geboers et al. 2016).
In contrast, higher levels of health literacy are associated with increased patient involvement in shared decision making (de Oliveira et al. 2018; Seo et al. 2016), which is important in patient-centred care. Improving health literacy is therefore a key element in allowing people to partner with health professionals for better health.

Strong health literacy has also been found to be important in enabling people to identify and reject medical misinformation, as experienced during the COVID-19 pandemic.

Health literacy in Australia

So, how do Australians rate when it comes to health literacy? In short, not very well.

The Australian Bureau of Statistics (ABS) conducted an Adult Literacy and Life Skills (ALLS) survey of Australians aged 15 to 74 years in 2006. This survey graded the proficiency of participants’ health literacy as Level 1 (lowest level of health literacy proficiency) through to Level 5 (highest level), with Level 3 representing the minimum level of proficiency needed to effectively engage with health information.

Overall, there was little variation between males and females across all age groups, with 40% and 41% respectively demonstrating a Level 3 or higher proficiency. However, this indicates that some 60% of the Australian adult population have limited health literacy.

In 2018, the ABS conducted a National Health Survey on Health Literacy. Consistent with the IHA’s definition of health literacy, this survey moved away from assessing the health literacy proficiency of Australians to collecting data that can “…be used to improve health service provision”. This survey found that 91% of Australians felt they could actively manage their health but the results indicated that their certainty declined with their health:

People who considered themselves to be in excellent health were more likely to strongly agree that they could actively manage their health (34%), compared with 11% who considered their health to be good and 9% of people who considered their health to be fair or poor.

A 2019 scoping review by Choudhry et al considered 27 health literacy studies conducted on Australians after the ALLS survey. This review concluded that Australian consumer health literacy levels remained very low, including in indigenous populations.

Factors that influence personal health literacy

A person’s health literacy is not static.

Just like other kinds of literacy, it evolves. The degree to which it grows is dependent on a range of factors, including the level of education the person attains, the impact of disabilities, their socioeconomic group, as well as whether they come from a culturally and linguistically diverse background or live in a remote community. However, health literacy can also be depleted or eroded.

The ALLS survey showed health literacy tends to decline after age 40, with a steep decline occurring from age 60. The survey notes this may reflect generally lower levels of education in these cohorts, rather than age-related cognitive decline. In contrast, the findings of a 2023 study of Australians aged 65 years or over ‘…suggest increasing age is associated with greater confidence in engaging with [health] providers, accessing information and navigating services, particularly for those living with chronic illnesses’.

But the researchers also noted lower health literacy skills in people with poor English or people experiencing psychological distress. Stress and mental illness (including anxiety and depression) are known to impair focus, comprehension, motivation and decision-making abilities, which would affect a person’s ability to interpret and act on health-related information.

As indicated by the 2018 ABS survey, chronic illnesses can also adversely impact health literacy. Some illnesses, like diabetes and cardiovascular disease, can cause cognitive impairment, which in turn, will deplete health literacy. Chronic pain and fatigue, such as that caused by arthritis and fibromyalgia, can make it difficult to focus, creating health literacy challenges. Pregnancy, menopause and cancer are all associated with cognitive impairment (including ‘brain fog’), again creating health literacy challenges. And chronic conditions in general can increase the risk of mental illness, especially depression.

A person’s health literacy may also be challenged by the stress of the chronic health conditions of their child or someone else they care for.

How health literacy impacts on the ability to interpret advertising

Advertising for medicines or medical devices is just another type of health-related information. Like other health information, people will rely on their health literacy to read and interpret it. For those with low health literacy, the advertising may:

  • cause confusion (and not achieve its intended purpose), or
  • mislead them into thinking the advertised good is suitable for them (when it isn’t), including inferring the good has properties that it doesn’t have.

In Australia, consumer advertising for therapeutic goods must comply with the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code (Code). The Objects of the Code state:

The objects of this Code are to specify requirements for advertisements about therapeutic goods so that advertisements:
(a) promote the safe and proper use of the therapeutic goods by minimising misuse, overuse or underuse; and
(b) are ethical and do not mislead or deceive the consumer or create unrealistic expectations about the performance of the therapeutic goods; and
(c) support informed health care choices; and
(d) are not inconsistent with current public health campaigns.

In other words, the Code requirements exist to help people correctly interpret and understand therapeutic goods advertising to support making informed health care choices, thereby imposing health literacy obligations on advertisers.

The Code foreshadows that health literacy, and a range of other factors, can impact on how people interpret advertising. To address this, the Code specifies that:

This Code applies, in relation to a particular advertisement, by reference to its likely impact on a reasonable person to whom the advertisement is directed.

Therefore, if an advertisement is directed to a particularly vulnerable group of people who are known to have limited health literacy, extra care will be needed to ensure the advertisement is clear and does not mislead.

Unlike in the United States of America, prescription medicines cannot be advertised to Australian consumers, unless it is done by (or on behalf of) the Australian Government or a state or territory government. An example is the government advertising for the COVID-19 vaccines to build Australians’ health literacy around where to get vaccinated and the benefits of getting vaccinated.

However, prescription medicine sponsors can lawfully disseminate disease education advertising to consumers that encourages them to talk to their doctor or other health practitioner about a particular disease or condition to explore prevention or treatment (which might include a prescription medicine). Such advertisements are another important contribution to Australian health literacy.

Seeside social media

So, you’ve received an infringement notice

Receiving a fine, also called an infringement notice, from the Therapeutic Goods Administration (TGA) can be daunting. Never fear, here are Seeside’s tips on handling an infringement notice for non-compliant therapeutic goods advertising.

The Therapeutic Goods Act 1989 (the Act) sets out requirements for the manufacturing, import, export, supply and advertising of therapeutic goods. When the TGA encounters activities that don’t comply with the Act, it can take a number of actions, ranging from educational and warning letters to court action. The TGA can issue an infringement notice as an alternative to court action. But if a recipient does not handle an infringement notice appropriately, they can still end up in court.

Handling an infringement notice

  1. Don’t panic! But don’t ignore it—because it won’t just go away.
    If you ignore it, the TGA could take you or your business to the Federal Court of Australia. Court proceedings are far costlier than infringement notices—it will certainly take more of your time and money.
  2. Identify the date that payment of the infringement notice(s) is due.
    Any action you are going to take in relation to the infringement notice needs to happen by this date. Otherwise, you could end up in court.
  3. Check that you are indeed responsible for the advertising the TGA has issued the infringement notice(s) for. The TGA checks carefully before issuing infringement notices so it’s unlikely they have sent it to the wrong person. But if it is a case of mistaken identity or someone else was responsible for advertising under your business name, you may have grounds to request the infringement notice(s) be withdrawn.
  4. Identify the advertising referenced in the infringement notice(s) and the laws the TGA alleges have been breached by that advertising.
    • The TGA generally only issues infringement notices for clear-cut matters. It’s unlikely the TGA would accept an advertiser’s argument that no breach has occurred and withdraw the infringement notice.
    • With this in mind, you will need to address the advertising issues the TGA identified in the infringement notice(s). You will need to remove the whole advertisement if you can’t edit it to remove the compliance issue(s).
    • Where the advertising appears on your business website or social media, you should remove or modify it immediately.
    • For other online advertising or newspaper, magazine, radio or television advertising, you should issue an immediate written instruction to cease or amend the advertising.
    • Make sure you address any similar advertising across your business platforms (not just the advertisement(s) identified by the TGA).
  5. Determine how you wish to address the infringement notice(s). Given the serious consequences of ignoring an infringement notice, your best options are to:
    • Pay the infringement notice(s)
    • Request the TGA to withdraw the infringement notice(s)
  6. If you wish to pay the infringement notice(s) but finances are tight—you can write to the TGA, requesting an extension of the time to pay under section 42YKB of the Act. The Act doesn’t specify any criteria for such requests. However, the infringement notice may set out suggested information to include in your request. Your request should include reasons for your request and corroborating evidence (if available) or an offer to provide evidence.
  7. Under the section 42YKC of the Act, you can request the TGA to withdraw the infringement notice(s). You can request this after the infringement notice has been paid (the TGA will refund you if approved). No specific information is required, but you should set out a rationale for why the infringement notice(s) should be withdrawn. If the TGA refuses your request, you will have to pay the infringement notice(s).
  8. On paying the infringement notice(s), write to the TGA to advise payment was made and explain the steps you have taken to address the compliance issue(s).
  9. When the TGA issues an infringement notice, it generally publishes a media release that identifies the offending business. Media outlets may seek your comment about it—especially if there is a public interest in the advertised goods (e.g. vapes) or you have a high-profile business. You may wish to prepare a standard written response you can issue to such inquiries.
  10. Paying the infringement notice(s) means that the TGA cannot pursue court action for that matter. However, if you reuse the offending advertising or advertising claims, the TGA would consider it a new matter.

Dealing with the TGA (keep it clean)

It is essential that you (and your staff) maintain a professional and respectful demeanour when dealing with the TGA. This will work in your favour when the TGA considers whether to grant extension or withdrawal requests for infringement notices. It may also influence the TGA’s approach to future compliance issues with your business—a professional business that seeks to be compliant is less likely to end up in court than a belligerent operator that argues with the TGA at every opportunity.

Seek expert advice

You can seek advice from a lawyer or experienced regulatory consultant, like Seeside Advisory, to assist you with handling an infringement notice for non-compliant therapeutic goods advertising. We can also help advise you on how to bring advertising into compliance. You should aim to provide your chosen advisor as much time as possible to consider the issue and provide recommendations.

Further information

Information about the TGA’s infringement notices

How the TGA manages regulatory compliance

How the TGA manages advertising compliance

Seeside – Advertising therapeutic goods 101: where to start?

Future trends in advertising compliance: AI

Artificial intelligence (AI) is currently a hot topic, with a media focus on the potential for AI to advance unfettered. But AI is already accessible to millions of Australians with internet access and is actively in use by a wide range of government authorities. For example, traffic infringement cameras that use AI to identify drivers illegally using mobile phones or not wearing seatbelts are in use in most states and territories, and the Australian Taxation Office has been using AI for some years, including to identify non-compliant tax payers. It won’t end here.

In the push for more efficient government agencies that deliver more bang for the tax-payers buck, AI offers the opportunity for regulators to work smarter by automating at least some aspects of compliance and enforcement work, including the identification of non-compliant entities and activities.

AI can identify non-compliant advertising

In 2023, the United Kingdom’s Advertising Standards Authority (ASA) implemented an AI-based Active Ad Monitoring System. This system supported multiple projects in 2023, including curtailing the online promotion of youth vaping and prescription-only medicines, and its scope will be expanded in 2024. The system works by capturing online advertisements and searching them for specific compliance issues. While staff are still needed to review each advertisement flagged by the system to confirm the compliance issue and determine the need for compliance action, the system will continue to learn and get better at identifying non-compliance. The ASA’s system currently processes around 100,000 advertisements a month—that’s more than 3,300 a day and far more than could be achieved by searching and screening manually. And there is the potential for it to screen even larger numbers of advertisements. Ireland’s ASA has also announced it will be using AI to proactively identify breaches of the advertising rules.

The future of AI in regulation

A 2023 report published on the Australian National Audit Office website about the Therapeutic Goods Administration (TGA) and the way it manages non-compliance doesn’t specifically mention that AI is being used in the compliance space. However, the report indicates the TGA engages with other entities (including other government agencies and private sector experts) to inform its intelligence gathering—and it’s possible these entities use AI. Further, the TGA’s budgets and resourcing is unlikely to keep pace with the rising popularity and rate of online advertising (including through social media), so employing AI to help it identify non-compliance seems the obvious next step.

AI also offers regulators opportunities in relation to research and policy setting. For example, each year, the TGA sets its import, advertising and supply compliance priorities. Such priorities could be informed by analysing data from the usual information sources (like feedback from the community and other regulators, or trends in non-compliance identified from internally collected data). AI could add another dimension to this analysis, with the ability to provide insight into emerging trends in the advertising of therapeutic goods before they become publicly obvious.

Interested in using AI to generate or power your medicines or medical devices advertising? Read Seeside’s advice on where you might need to pay some extra attention to avoid compliance issues – Intelligent advertising: using AI in medicine and medical device advertising.

Further reading

For regulated entities (like advertisers):

AI and regulators:

Intelligent advertising: using AI in medicine and medical device advertising

Artificial intelligence (AI) is an exciting prospect in advertising. It’s accessible to everyone with internet access. It can create advertising, personalised content and experiences, images and other written content (including social media posts). It can also power a chatbot on your website and do your data analysis for you. And behind the scenes on your social media and search engine platforms, AI is in full swing, determining who sees which advertisements.

But there are a few things to be mindful of if you are using AI to generate or power advertising for therapeutic goods (such as medicines or medical devices).

The advertising of therapeutic goods to Australian consumers is subject to special rules set out in the Therapeutic Goods Act 1989 (Act) and the Therapeutic Goods Advertising Code (Code). These rules do not prohibit the use of AI in advertising. However, the rules will impact on how you use AI in relation to your advertising. Here are Seeside Advisory’s top tips.

1. The advertiser is still responsible for the content

If you use AI to generate content that is (or forms part of) your advertising, you are still responsible for the compliance of it—meaning, you will need to review and decide whether it is compliant before releasing it.

In particular:

  • You will need to be able to substantiate all the claims made in the advertisement with suitable evidence (see the TGA guidance on this subject).
  • Images conveying or portraying advertising claims are also subject to the Act and the Code. For example, using AI to alter an image of a person to convey the weight loss possible from the use of the advertised good must comply with the Act and the Code, including the specific requirements for weight management products. Under the Code, advertisers can only use visuals that are consistent with what can be achieved on average from the use of the advertised good (clause 23(4)(c)). Further, it would need to be clear to viewers that they were seeing an AI generated image, otherwise the advertisement would mislead (thereby breaching Code clause 8(1)(a)).
  • AI may use advertising tools and tactics acceptable for other types of health products but that are explicitly prohibited in medicines and medical devices advertising – e.g., doctor endorsement, suggesting other products are ineffective.
  • Consider whether you need to clearly identify the advertisement (or parts of it) as AI generated in order to avoid misleading consumers.
  • AI is also unlikely to automatically include the mandatory statements the Code requires in medicines and medical devices advertising (e.g. ‘Always read the label’) so you will need to add these.

Remember that personalised content promoting the use or supply of therapeutic goods, even if it is only being seen by one person, is still advertising and will need to comply with the Act and the Code (unless it is being provided by a health practitioner directly to a patient as part of a course of treatment[1]).

Our June 2024 blog post contains more information about the definition of advertising and the types of content that could be captured.

2. Chat bot content can be advertising

Using AI to streamline engagements with customers online is helpful for businesses. However, it’s important to remember that the responses from a chat bot may be considered advertising in and of itself, especially when considered in the context of a promotional website. And if it is advertising, it needs to comply with the Act and the Code (including the mandatory statements).

Remember that the definition of ‘advertise’ in the Act includes the promotion of the use or supply of the goods (my emphasis), giving it a very broad scope. So you will need to review your chat bot scripts and test it carefully for compliance before implementing it.

3. Don’t be tempted to use AI to create testimonials or celebrity endorsements

Falsifying testimonials and endorsements is unlawful, whether or not you use AI to generate them.

The Australian Competition and Consumer Commission (ACCC) has previously fined and taken court action against advertisers that have manipulated customer reviews or created their own reviews. Such actions will also breach the Code because the resulting ‘testimonials’ are misleading. The same applies to AI-generated celebrity or politician endorsements.

There is another reason not to use these things. Fake celebrity endorsements are common on the internet and social media channels. And they often seem to be a front for nefarious purposes. If you are building a legitimate business, you don’t want to damage your reputation by getting on this bandwagon. Savvy people will also recognise them as fake and not bother to click through.

4. Influencers—human and AI

Then there is the curious case of the AI influencers—personas generated by AI to promote products on social media. They are touted as giving advertisers more control over promotional content than they would have with a human influencer. While some AI influencers do have humans writing the social media posts behind the scenes, others use AI to generate content. Ultimately, if you decide to use an AI influencer to promote therapeutic goods, you will likely be held responsible for any compliance issues with the advertising it generates[2].

As with human influencers, care will be needed to ensure the content generated by AI influencers to promote therapeutic goods complies with the Act and the Code. Seeside recommends that you:

  • choose your influencer (AI or human) carefully to ensure they are compatible with the medicine or medical device you want to advertise;
  • ensure that the process for generating the advertising supports compliance checks on content before it is released; and
  • craft the content for the AI influencer carefully to ensure it does not claim or suggest that the AI influencer has used (or will be using) the product being advertised (as it would be misleading).

5. Other legislation could impact on the way you use AI in your business

Australia, like other countries, is still considering whether its regulatory frameworks are fit for purpose in relation to the current AI challenges and the challenges that are likely to pose in the future as the technology advances.

Privacy is a specific area of concern. The Office of the Victorian Information Commissioner’s statement on Artificial Intelligence and Privacy articulates the risks to privacy and the challenges to the central principles of privacy laws (such as not collecting more personal information than is needed) through the use of AI.

To protect your clients and your business, Seeside recommends taking the following steps:

  • Don’t enter sensitive information, like health information, into AI tools. This could breach the Commonwealth’s Privacy Act 1988.
  • Before using AI with other client data (e.g. to gain insights into client purchasing or to prepare personalised marketing), assess whether your use of AI might undermine your relationship with clients, including by conflicting with your privacy obligations (e.g. under the Privacy Act 1988), your client’s consent and your business’s privacy policy.
  • Monitor for relevant changes to the regulatory environment. For example:
    • Changes to the Commonwealth’s Privacy Act 1988 are expected in the second half of 2024 that will strengthen protections, including those around consumer consent.
    • Professionals should keep abreast of best practices with respect to AI in their sector and ensure that any use of AI complies with the relevant policies and regulation of their profession.
  • If you are uncertain about applying relevant legislation, you may need to seek legal advice.

6. The consequences of non-compliant advertising

The use of AI offers businesses a range of benefits in relation to advertising, including helping to generate advertising faster and the ability to grab your audience’s attention using slick AI-generated graphics or AI influencers. But what use are all these benefits if the resulting advertising is non-compliant and gets you into trouble with regulators?  

Your competitors or members of the public are likely to report advertising that doesn’t comply with the Act or Code to the TGA—whether the advertising is AI generated or not. You also can’t hide behind an AI influencer. The first place the TGA will look is the business responsible for the product the AI influencer is promoting. The TGA also has a range of legislative powers to obtain information, including information to establish the entity or entities responsible for the advertising.

Failing to comply with the Act and the Code can result in bad publicity for your business, fines and even court action. The level of action the TGA will take against non-compliance depends on a range of factors, including the safety of consumers, whether you have previously received education from the TGA and whether the subject matter is captured under the TGA’s compliance priorities. But the TGA website is full of examples of advertisers that gambled on the risk and lost.

It’s just not worth using non-compliant advertising (whether AI assisted or not), even if you think it will give you a competitive edge.

Did you know that regulators are using AI to identify non-compliance? While not currently widespread, Australian regulators’ use of AI will likely grow. Read Seeside’s post on Future trends in advertising compliance: AI.

7. Further reading

[1] The main advertising offences in the Act are framed in the context of what a person advertising, or causing the advertising, of a therapeutic good must and must not do (see sections 42DL, 42DM). An advertiser that engages an AI or human influencer to promote a therapeutic good on the influencer’s own social media is likely to be considered to have caused the advertising, if not the advertiser themselves. The influencer can also be considered the advertiser.

[2] Information provided by a health practitioner directly to a patient as part of a course of treatment may be exempt from the majority of therapeutic goods advertising requirements, provided the conditions in subsection42AA(4) if the Therapeutic Goods Act 1989 (the Act) are met.  

Advertising 101: What is (and isn’t) advertising therapeutic goods

If you are providing information about medicines, medical devices or other therapeutic goods to members of the public, you need to know whether that information is advertising. If it is, the information must comply with the therapeutic goods advertising laws.

Information is considered advertising if it meets the definition of ‘advertise’ in the Therapeutic Goods Act 1989 (the Act). This is a very broad definition and will likely capture most of the information you release to members of the public about therapeutic goods.

The definition of ‘advertise’

The legislative definition for ‘advertise’ is:
advertise, in relation to therapeutic goods, includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:
(a) is on the label of the goods; or
(b) is on the package in which the goods are contained; or
(c) is on any material included with the package in which the goods are contained.

The definition in a nutshell

This definition has the following key elements:

  • Any promotional content about the use or supply of therapeutic goods is advertising.
    • The promotional effect may be direct or indirect means.
  • There are no exclusions, exceptions or carve-outs –
    • all means of imparting a promotional message are captured, including verbal and written statements, pictorial representations and actions, and
    • all mechanisms and channels used to convey a promotional message are captured – including labels and packaging.
  • There is no requirement for a minimum audience size or for the content to be a paid promotion.

The TGA’s guidance on Activities that represent advertising provides some examples to demonstrate the breadth of this definition. Importantly, the breadth of what may constitute a promotional message, and the way in which it is distributed, ‘future proofs’ the definition. So, for example, if future advertising methods involve beaming promotional ‘feelings’ or ‘desires’ straight into the brain, it will still be captured as advertising (and therefore would be subject to the advertising laws).

If you are interested in unpacking the definition itself, the following video takes a deep dive into it.

Some key considerations

Intent is gauged by the audience

The TGA has consistently indicated[1] that the intention referenced in the definition of ‘advertise’ is not necessarily what you as the advertiser intended—it’s what the viewer thinks is intended.

This makes it important to always consider information you are providing to members of the public from their perspective. It also needs to be considered in context, including any indirect cues that the audience may detect and assign meaning to (e.g., from the actions of the actors in the advertisement).

N=1 is enough to be an audience

The definition of advertise does not require content to be universally available in order to be considered advertising. So a personalised email sent to a single person only, or a small group of people, can still constitute advertising (if it meets the definition). Chatbot responses can also be advertising, as can a discussion between a seller and a potential customer[2].

Further, you don’t need to have paid for the content to be disseminated for it to be considered advertising. So a regular post on the social media account for your business that promotes the use or supply of a therapeutic good is an advertisement, just the same as a paid or boosted post on social media to promote a therapeutic good.

Promoting use vs promoting supply

The definition of ‘advertise’ captures the promotion of two different aspects of the therapeutic goods concerned—the use of those therapeutic goods or the supply of those therapeutic goods.

Promoting the use of therapeutic goods can be as simple as a statement that says “Take Bob’s Vitamin D capsules”. More commonly though, content that promotes the use of therapeutic goods is promoting the use of those goods for a reason, such as its particular therapeutic effects or quality. For example:

  • Bob’s Vitamin D capsules are easy to swallow.  
  • Clinical trials show Bob’s Vitamin D capsules are more effective than [the market leader] for preventing vitamin D deficiency.
  • All the cool kids are taking Bob’s Vitamin D capsules to avoid a deficiency this winter.

Examples of promoting the supply of therapeutic goods include:

  • A sign in a shop window saying “Bob’s Vitamin D capsules available here”
  • A newspaper ad stating there is 10% off Bob’s Vitamin D capsules at Bobble’s Pharmacy this month

So simply promoting the supply of therapeutic goods is enough to be considered advertising, even if it doesn’t say what benefits those vitamins might offer.

Product names can be advertising

The name of a medicine, medical device or other therapeutic goods can be promotional in and of themselves. For example, if a medicine called ColicSTOP, it indicates it will stop colic, with the inference being it will be absolute in its action. This is therefore a promotional name and, even if used in isolation from any other content, will constitute an advertisement.

Context is also important

The information before, after or surrounding content about therapeutic goods can cause that content (that might otherwise be factual and informational) to be considered advertising or a part of an advertisement.

For example, a magazine article about vitamin D explains what it is, why it is needed in the body, where humans normally get their vitamin D from and why Australians are often deficient in it. On the opposite page, there is an advertisement stating there is 10% off Bob’s Vitamin D capsules at Bobble’s Pharmacy this month. Readers will consider the information in the pharmacy advertisement in the context of what they have read in the article, spurring them into action to obtain the capsules. Therefore the article and the pharmacy advertisement constitute a single advertisement that needs to comply with the advertising laws.

Comments by third parties on your business website or social media about therapeutic goods can also meet the definition of an advertisement. While your website or social media may not refer to the specific therapeutic goods the third party is commenting on, the inclusion of the comment in the context of your business advertising can result in the content being an advertisement for therapeutic goods.

Also remember that hashtags on social media posts will be considered part of your advertisement.

Worked example

Let’s apply the definition of ‘advertise’ to a scenario.

A customer contacts a health food shop via the live chat facility on the website to ask how much their own brand 500mg vitamin C tablets cost. The staff member responsible for responding to chats prepares three possible responses. Which of these answers do you think would be considered advertising?

  1. Our 500mg vitamin C tablets are normally $20 but for today only, you can get 2 bottles for $25.
  2. A bottle of 50 x 500mg vitamin C tablets is $20.
  3. Our 500mg vitamin C tablets are $20. They are sugar-free and don’t contain any artificial colourings or flavourings. They are great for supporting your immune system, especially over the winter period. You won’t find a better value for money vitamin C anywhere else.

The first response is creating a sense of urgency for the customer to act immediately to buy the tablets to get the special price – so it’s promoting the supply of the tablets through that shop.

The last response is promoting the virtues of the shop’s particular vitamin C tablets – promoting both the use (for supporting the immune system) and supply (because they are sugar-free etc and the good price).

The second response is different – it’s a ’no frills’ response that, on face value, is not trying to persuade the consumer and is arguably not advertising. But what if the chat bot used the cookies on the customer’s computer to calculate a price that undercut the other retailers the customer approached with the same question? Then it too would be indirectly promoting the supply of the goods.

What’s not advertising?

It’s difficult to categorically define what would not be considered advertising (in the context of the therapeutic goods laws). This is because it is heavily dependent on the information communicated, the way it is communicated, who communicated it and the context in which it is conveyed.

For example, a statement indicating that the human body needs vitamin B12 to make red blood cells can be considered a factual statement that has no embellishment (e.g., adjectives, superlatives etc). But when used in the context of an advertisement about how Bob’s Vitamin B12 has high bioavailability (best absorbed by the body) and how it’s the best value for money, it forms part of the promotion of the medicine. And the advertisement as a whole must comply with the Act and the Therapeutic Goods Advertising Code (the Code).

This doesn’t mean that businesses can’t put information in the public domain about their therapeutic goods at risk of it being considered advertising. But careful consideration will need to be given to the information to be conveyed and where it will be disseminated. The TGA’s guidance on preparing ASX and company announcements contains useful advice on preparing content in a way that does not promote the therapeutic goods concerned and provides useful examples.

As we have seen above, a response to an unsolicited enquiry from a member of the public can be promotional or non-promotional. So care is needed with these responses – they always need to be considered in light of the definition of ‘advertise’.

Why you should get professional advice

It can be difficult for business owners, managers and content creators to independently and critically assess their own content – as humans, there are multiple biases at play, which often lead to an erroneous conclusion that content is non-promotional.

Obtaining independent advice from an experienced lawyer or reputable regulatory consultant, like Seeside Advisory, can help you establish whether content is promotional and, if so, whether it complies with the Act and the Code. We can also advise you on whether there may be a way to publish the information you want to in a non-promotional way.

And if you receive an advertising non-compliance letter from the TGA, don’t try to avoid regulatory action by arguing the subject content isn’t advertising. Or that you didn’t intend to promote the goods. These excuses just won’t fly. Instead, seek assistance from an experienced lawyer or regulatory consultant as quickly as possible so they can help you respond appropriately to the TGA by the deadline.

Further information

The Safe Practice Podcast – Dr Maria Li interviews Professor Tony Lawler from the Therapeutic Goods Administration on the Perils and Pitfalls of Advertising Therapeutic Goods

[1] For example, see the webinar on Advertising cosmetic injection health services compliant with therapeutic goods legislation and the Advertising guidance for providers of disease education activities.

[2] Where such discussions occur between a health professional (including a doctor, pharmacist or nurse) and a patient about a course of treatment, even if promotional content is conveyed it will be exempt from most of the therapeutic goods advertising laws.

Advertising therapeutic goods 101: where to start?

At Seeside Advisory, we strive to provide you with valuable insights and expertise through our professional blog posts. In our latest edition, we take a look at what new advertisers, or advertisers new to advertising therapeutic goods, need to know before getting started.

Lesson number one

Don’t rush – therapeutic goods advertising needs extra care

Under Australian Consumer Law (ACL), advertising for goods or services must not be false or misleading. For therapeutic goods advertising, there are additional and very specific legal requirements that must be met. These are set out in the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code (the Code). The Therapeutic Goods Administration (TGA) is responsible for ensuring advertisers comply with these rules.   Seeside Advisory recommends you allow additional time in your marketing schedules so that therapeutic goods advertising can be checked for compliance with the Act and the Code.

Number two

Establish the type of therapeutic good you want to advertise

Before advertising, clearly identify the type of therapeutic good involved. There are two key reasons for doing this:

  • You need to ensure it is not a type of therapeutic good that is prohibited from being advertised to consumers. Therapeutic goods that cannot be advertised to consumers include:
  • Prescription Only medicines (except as part of an advertisement for vaccines/vaccination services and pharmacy prescription price lists)
  • Controlled drugs (like opioids)
  • biologicals (cell and tissue based products)
  • most Pharmacist Only medicines
  • unapproved therapeutic goods, such as medicinal cannabis and medicines and medical devices that are experimental
  • The type of therapeutic good (Pharmacist Only medicine, other medicine, medical device or ‘other therapeutic good’) you want to advertise will determine the key information you must include in the advertisement.

You can generally work out the type of therapeutic good by asking the supplier or looking it up the Australian Register of Therapeutic Goods (select the option to read the summary PDF).

Number three

Familiarise yourself with the advertising requirements

The TGA provides a range of information and tools to assist with understanding the therapeutic goods advertising requirements and complying with the Act and the Code.

Some of the key issues new advertisers should be aware of include:

  • Claims about the screening, diagnosis, treatment, cure or prevention of cancer are banned. There are, however, exemptions for claims about preventing skin cancer through sunscreen use.
  • Claims referring to other serious diseases or conditions are ‘restricted representations’ and require approval from the TGA before being used.
  • Under both ACL and TGA laws, advertisers must be able to substantiate their advertising claims. This includes claims about the effect of the goods (e.g. relieve hayfever), other features of the goods (e.g. easy to swallow, no artificial colours) and pricing (e.g. recommended retail price versus our price).    
  • Endorsements by health professionals, including doctors and pharmacists, are prohibited.
  • Most advertisements for therapeutic goods must include certain information to support consumers in making an informed decision about whether the advertised good will be right for them. The information needed is specified in the Code and varies depending on the type of good and the type of advertisement.
  • Advertising claims must not be inconsistent with the indications or intended purpose recorded in the Australian Register of Therapeutic Goods for the medicine or medical device. They also must not conflict with the directions or instructions for use.

Number four

If you aren’t sure, seek professional advice

If you aren’t sure of type of therapeutic good you want to advertise or you are unsure if the advertising will comply with all the relevant laws, hold off on your advertising until you have sought advice from a lawyer, the TGA or a professional therapeutic goods advertising compliance consultant, like Seeside Advisory.

If you found this blog post useful, stay connected with Seeside Advisory for more insightful content. Sign up for our newsletter or follow us on social media to receive regular updates and inspiration for your next advertising project.

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Welcome to Seeside’s blog

Welcome to Seeside’s blog, your trusted source for professional insights and expert advice on therapeutic goods advertising regulation. We are here to provide you with valuable information and resources to help you navigate the complexities of this world.

At Seeside Advisory, we understand the importance of making informed decisions in your professional life. That’s why we’re committed to delivering high-quality content that is both educational and engaging. Our blog articles are designed to address your specific needs and provide you with valuable insights to help you succeed.

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