Source: Australian Department of Health
Ads for therapeutic goods must comply with the requirements of the Therapeutic Goods Act 1989 (the Act), administered by the Therapeutic Goods Administration (TGA). Any advertisement that is accessible by consumers must meet the requirements of the Act and the Therapeutic Goods Advertising Code (No.2) 2018 (the Code).
The advertising requirements apply to any advertisement for therapeutic goods appearing in the public domain, even if the product advertised is not available for consumers to purchase or consumers are not the intended audience of the advertising.
Where the advertising complies with the requirements of the Act and Code it is not necessary to ensure it is only available to health professionals, even if health professionals are the intended audience.
The advertising requirements in the Act and Code do not apply to ads that are directed exclusively to health professionals – i.e. advertisements that are inaccessible to consumers. However, for practical reasons, advertisers of therapeutic goods that consumers are unable to buy (e.g. certain products used in dental practices or some hospital supplies) may not want to restrict access to the advertising, even though the advertising is targeting health professionals or their purchasing officers.
This fact sheet explains how advertisers can make it clear in publicly available content that a therapeutic good is only available to health professionals, while still ensuring compliance with the therapeutic goods advertising requirements.
Non-promotional, factual information (such as scientific/medical information) does not need to be restricted from consumers and does not need to comply with the advertising requirements in the Act and Code. Examples of non-promotional material include:
- reference material, factual informative statements or announcements, trade catalogues and price lists, provided that they do not make promotional claims (including price promotions)
- 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
Where non-promotional content identifies therapeutic goods, these can be identified in the content with ‘THESE PRODUCTS ARE ONLY AVAILABLE FOR SALE TO HEALTH PROFESSIONALS’ (or similar) if appropriate.
Further information on identifying whether content is promotional is available from Activities that represent advertising.
Advertising intended for health professionals
Where content is promotional (i.e. advertising) but relates to products consumers cannot purchase, it is up to the advertiser to decide on the most appropriate method of advertising these products.
Advertisers can choose to either secure the advertising such that it can only be accessed by health professionals OR make it clear that the advertised therapeutic good is not available for purchase by consumers.
Option 1: Direct the advertising exclusively to health professionals
For advertising to be considered to be directed exclusively to health professionals, the content must be restricted so that it can only be accessed by health professionals. There are a number of ways to achieve this, for example securing the material behind a firewall.
Restricting advertising from consumers means advertisers can avoid having to ensure compliance with the advertising requirements (including the use of mandatory statements).
The TGA fact sheet: Advertising to health professionals explains how to direct advertising exclusively to health professionals.
However, where the requirements of the Act and Code are met, it isn’t necessary to restrict access to the advertising from consumers, regardless of the intended audience.
Option 2: Advertising in the public domain for therapeutic goods that are only sold to health professionals or related entities
If an advertised therapeutic good is not available for purchase by consumers, and the advertising appears in the public domain, advertisers may choose to include a statement in their advertising to the effect that ‘THESE PRODUCTS ARE ONLY AVAILABLE FOR SALE TO HEALTH PROFESSIONALS’, or similar.
The use of this statement may be appropriate where an advertiser chooses not to restrict the advertising from consumers, but wishes to make it clear that the advertised goods are not suitable for purchase by consumers.
As the ad is publicly available, to avoid non-compliance, advertisers must ensure that the ad meets the relevant requirements of the Act and the Code, including the prohibition on advertising prescription substances and the requirement to include mandatory information and statements.
Mandatory statements required in therapeutic goods advertising
There are particular mandatory statements required in ads for medicines, medical devices and other therapeutic goods. These statements provide consumers with important information about the product, any applicable warnings about using the product, and advice to seek assistance if required.
The TGA decision tree: Mandatory information required in advertising for therapeutic goods assists advertisers to identify what information must be included in an ad for therapeutic goods.
For more information, visit the TGA advertising hub.