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Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
Guidance for advertisers
Activities that represent advertising
This guidance for advertisers applies to the current Therapeutic Goods Advertising Code 2015 but incorporates amendments to the Therapeutic Goods Act 1989 (the Act) that came into effect on 6 March 2018, and has been further updated to provide specific information on advertising biologicals and to also include more background information on advertising requirements.
The Therapeutic Goods Advertising Code (No.2) 2018 was made on 31 October 2018 to replace the 2018 Code which will come into effect on 1 January 2019. A summary of the changes is available. To assist advertisers with implementation, we have also published guidance material; Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
Not all information released to the public about therapeutic goods is advertising. However, if information you release intends (from the end viewer's point of view) to directly or indirectly promote the use or supply of a therapeutic good then we would likely consider it to be advertising and it must meet legislative requirements as set out in Act and the Code (see Advertising and the Act).
Promotional activities and materials are considered advertising
We consider promotional material to be a form of advertising. Even if the material or the format of advertising can be said to promote the use or supply of relevant goods only in an indirect way, the material or format will still be an 'advertisement'.
Information that is purely factual and balanced and is disseminated for the appropriate use of the goods (for example, consumer medicine information, instructions for use) is unlikely to be considered promotional.
Characteristics of promotional material
Your information is more likely to be considered promotional if it contains:
- unsolicited information rather than solicited information
- unbalanced information (for example, it focuses on the positive qualities of a therapeutic good and omits or downplays the negative qualities such as possible side effects or limitations of use)
- the use of superlatives, for example, describing a therapeutic good as 'the best' or 'works fastest'
- the use of descriptive adjectives or statements that are emotive (for example, describing a therapeutic good as 'brilliant' or 'changed my life')
- information that is disseminated on multiple occasions with regular or semi-regular frequency (for example, three times a week during the evening news)
- any information that is disseminated by, or on behalf of, manufacturers, sponsors, retailers and any other party with a financial interest in the sale of the goods referenced.
Considerations when assessing communications
When deciding whether your information is an advertisement, we take into consideration the following factors:
- the context in which the information or activity occurs
- the audience the information is directed to, what their likely take-out message is and are they likely to consider it to be promotional
- the use of non-verbal and unwritten messages (such as pictorial elements). These may be just as important in assessing the communication and can alter the take-out message that viewers receive.
Forms an advertisement may take
Any promotional activity for a therapeutic good is likely to fall under the definition of an advertisement.
Advertisements may be targeted to the masses (for example, a newspaper advertisement for cold relief products), to a specific patient group (for example, an advertisement for blood glucose meters in a magazine for diabetics) or specific individual consumers (for example, a letter to individuals that have bought certain types of products from a retailer in the last 12 months).
Advertising is not limited to a specific type, or types, of media. It can include articles published in journals, magazines and newspapers, displays on posters and notices, photographs, film, broadcast material, video recording, electronic transmissions and material posted on the internet. Point-of-sale materials, leaflets, booklets and other promotional materials that include specific product claims and which are supplied separately from the product may also be advertisements. Words forming part of a soundtrack or video recording are within the definition of to advertise as is the spoken word. Product reviews and even product trade names can constitute advertising.
Depending on the content and the context in which such material is provided to the public, some documents and content may be considered not to be advertisements.
- reference material, factual informative statements or announcements, trade catalogues and price lists, provided that they do not make therapeutic or promotional claims
- information relating to human health or diseases where there is no reference to therapeutic goods
- advertising for health services that does not refer, either directly or indirectly, to therapeutic goods
- correspondence, possibly accompanied by material of a non-promotional nature, to answer a specific unsolicited question about a therapeutic good.
(A fact sheet providing more information on the differences between advertising and other activities is currently under development.)
The Act and the Code apply to digital communications channels such as social networking sites, blogs and discussion forums when these are used to promote therapeutic goods. Even when these dissemination tools are not used with the conscious intent to promote therapeutic goods, if this is the likely effect of the material on the reasonable consumer, then the material would be subject to the Act and the Code. Website and social media managers should:
- ensure that materials posted on the internet, including comments made by third parties, do not contravene the Act or the Code
- remove content that contravenes the Act or Code.
The labelling and package leaflet of a product, even if they comply fully with the labelling requirements of the Act, the Regulations, the Devices Regulations and the Labelling Orders, may still be an advertisement. If a label is an advertisement, it needs to comply with the Code (other than those specific sections that have an exemption for labels). This is also the case for Consumer Medicine Information and Patient Information Leaflets (for medical devices).
- The use of superlatives indicates a comparison (whether express or implied).