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?
- Our 500mg vitamin C tablets are normally $20 but for today only, you can get 2 bottles for $25.
- A bottle of 50 x 500mg vitamin C tablets is $20.
- 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.