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TGA workshop recording: SME Assist 'Meeting Your Obligations' - Advertising
This recording is provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the recording should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the recording.
Recording of workshop
- Workshop summary: Covers the general principles of advertising requirements for therapeutic goods and includes two case studies. This presentation is targeted at small to medium enterprises, start-ups, researchers and anyone who is unfamiliar with therapeutic goods regulation.
Hi my name is Faye Lux and I'm from the SME Assist team at Therapeutic Goods Administration.
Before I start today, I'd like to acknowledge the traditional owners of the lands on which I stand and pay my respects to their Elders past, present and emerging.
Today I'm going to take you through some slides which focus on advertising to help you understand these requirements.
These slides are a summary only and should not be taken as statements of law or policy.
This webinar on advertising is part of a series of webinars which provide more detail on the regulatory process for therapeutic goods.
Our other webinars cover:
- Market authorisation
- Manufacturing and;
- Post-market monitoring
These can all be found on the TGA website. However, don't wait until you have gone through the manufacturing and market authorisation processes before you think about advertising.
There are strict rules around what you can and cannot say when marketing your product to the public, once it is on the Australian Register of Therapeutic Goods or the ARTG.
These rules can affect the indications and labelling of your product so we encourage you to consider these requirements upfront.
In this webinar I'm going to provide a general overview of advertising requirements.
Advertising requirements apply to all therapeutic goods. It doesn't matter if it's a medical device, or a complementary medicine.
Some therapeutic goods, such as prescription medicines and biologicals have requirements that mean they can't be advertised at all to consumers.
So what is advertising?
Advertising is considered any promotional material and it includes things like, but not limited to:
- labels on your medicine and this includes packaging
- TV advertisements
- and websites, including social media
Advertising is regulated by the Therapeutic Goods Act, the Therapeutic Goods Regulations and the Therapeutic Goods Advertising Code.
Advertising is your responsibility.
The Therapeutic Goods Act and the Advertising Code apply to all therapeutic goods to varying degrees.
The Advertising Code outlines key requirements that must be met when advertising to the public.
Familiarise yourself with this piece of legislation and understand what you can and cannot do.
Make sure you are aware of your labels, or what any other advertisement says. Are you being misleading? Do you hold evidence that your product can be used in the way you are suggesting?
Don't wait until a complaint comes through to the TGA from the public, or we audit you to be compliant.
You can make changes at any time to correct mistakes and ensure you are compliant.
We have guidance material and contacts available to help you online and understand the Code requirements.
Here's a general overview of some of the legislation that's involved.
The Act prohibits, among other things:
- the promotion of therapeutic goods that are not on the ARTG when they should be
- the use of 'prohibited representations', such as references to cancer
- and the unapproved use of restricted representations, such as references to serious diseases and conditions.
The Act also requires advertisers to comply with the Advertising Code.
The Code regulates what can and can't be said when advertising therapeutic goods.
The sorts of things it covers include:
- and general requirements including accuracy, scientific or clinical representations, endorsements and testimonials
We have code guidance available to help advertisers interpret the Advertising Code.
This is best read in conjunction with the code and you can find this and other helpful guidance material online, on the Advertising hub which I will introduce to you in a later slide.
So why do we regulate advertising?
We regulate advertising because not only can a false claim be misleading, it can be unsafe.
Advertising must not be socially irresponsible, or mislead or deceive the consumer.
Advertisements must not make claims about medicines or medical devices for therapeutic uses that are not for the uses recorded on the ARTG as the medicine's indication or, are not the medical device's intended purpose.
You can see here in these examples how some advertising can be dangerous to the consumer.
Let's now look at a case study to put some of the advertising requirements into perspective.
This is Dan and he has a listed complementary medicine called 'Bean's Tonic'.
Let's look at what he shouldn't do when advertising on a label.
Although this example is of a medicine label, the breaches shown here would apply to any advertising material such as a TV ad or a magazine article, and they also apply for any therapeutic good that is allowed to be advertised to the public.
Let's go through some of the breaches.
The Advertising Code gives information about endorsements.
Your advertisement cannot be endorsed, directly or implied, by certain factions such as government organisations and/or health professionals.
In this example, 'Dr Seuss' is representing a real health professional.
He is saying he loves beans.
We might question if this is really supporting or endorsing the product? After all, all he is saying is that he loves beans.
However, because the name of the product is about beans, 'Bean's tonic' - this is taken to be an indirect endorsement of the goods and is considered a breach.
Graphics and images are not immune to advertising.
The government logo is enough to be a breach as it implies government endorsement.
Just because your goods have gone through market authorisation and are being supplied on the market, or they may have been reviewed post-market, this does not mean that the TGA endorses your product and you may not use a government logo.
You must not reference serious forms of diseases, ailments or conditions unless you have prior approval. We call these serious forms of diseases or conditions restricted representations.
In our example, they don't have prior approval, so using this restricted representation is a breach.
A restricted representation is defined clearly in the legislation, but in general, they are serious forms of diseases, conditions or ailments that ought to be diagnosed and managed by a health professional.
So this indication regarding diabetes is another breach, as diabetes is a restricted representation.
The last breach relates to the diabetes indication again.
You can't advertise an indication if it's not present on your ARTG entry.
This indication wouldn't be allowed on the ARTG entry because it contains an unapproved restricted representation.
You can't create or use an indication on your label that isn't on your ARTG entry.
Let's go to a second Case Study now looking at advertising and social media.
This is Daphne and she is the sponsor for a device called a TENS machine, TENSbest.
She has a Facebook page to help promote her product.
Here we've got a snapshot of Daphne's Facebook account and her most recent post. Remembering that social media platform posts count as advertising.
We can see here that the claims in the advertisement are pretty low level.
They don't seem to be exaggerated and they are responsible in terms of not encouraging people to delay medical treatment or ceasing a prescribed pain management strategy.
The photo is of generally healthy individuals and all applicable warnings are present.
So where's the breach?
Let's take a closer look at some of the comments made now by complete strangers.
Comments in a social media post are considered testimonials.
You as the sponsor are responsible in ensuring any testimonials comply with requirements.
For example, comments must illustrate typical cases and they have to comply with all other advertising requirements, they can't be misleading for example.
Mr Bikeman here is fine, he is making a simple statement, not reflecting on the product's capabilities.
Ana is also fine. She's making some reasonable statements about how she feels about the product and how it helps her.
Now though we get to Simon.
He has started to 'see' his bones getting thicker and stronger and he is telling everyone that this product will prevent rheumatoid arthritis.
This kind of statement isn't what we would consider typical of the results to be expected from the use of the goods.
It's also not a typical case, a typical case would be more along the lines of what Ana has said, about it providing a bit of pain relief in a general sense.
This comment also mentions a restricted representation, rheumatoid arthritis.
Now Daphne herself has not made any errors here in her post, but sadly, Simon has and it's the sponsor's responsibility to ensure all testimonials adhere to the Code.
So what can you do?
Moderate your posts and delete comments that are non-compliant.
Keep the positive and accurate testimonials once you are satisfied they comply with the Code, but remove those that are likely to land you in trouble.
Testimonials must be from verified users, illustrate typical cases and comply with all other requirements.
We have a lot of material available online to help you.
The Advertising hub on the TGA website is a one-stop shop for all information related to Advertising.
You can find guidance material and further information about complaints and applicable forms on this site.
You are also able to contact the Advertising team via email if you're unsure of requirements or need help interpreting the Code.
I also encourage you to visit the SME Assist hub on the TGA website. You can find this under the heading 'Industry'.
Here you will find guidance articles and decision tools on various introductory topics that will also help you.
And you can also contact the SME Assist team, the details provided here.
Thank you very much for your attention today. I hope that this webinar helps you better understand the advertising requirements.
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