New TGA guidelines on what better defines "Advertising"
On July 1st the TGA published online guidelines for advertisers that clarify among others what activities constitute 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'.” Also, unsolicited information is more likely to be considered promotional. Digital communications channels such as social networking sites, blogs and discussion forums when these are used to promote therapeutic goods must comply with the Therapeutic Goods Advertising Code 2018 as well.
Advertising of health services involving medical devices including IVDs is also subject to restrictions. An advertisement to the general public for a health service that specifies (whether directly or indirectly) the use of therapeutic goods would be likely to promote the therapeutic goods concerned. Such health service advertisements must, therefore, comply with the Australian therapeutic goods advertising legislation. There are some provisions of the therapeutic goods advertising legislation that also apply to advertising to health professionals.
Under the Therapeutic Goods Act 1989, it is prohibited and is an offence to advertise to any person a medical device that is not included on the ARTG. Unapproved devices (i.e., not included in the ARTG) may, under certain conditions, be accessed legally via the clinical trial pathway, the Special Access Scheme (SAS), the Authorised Prescribers (AP) or the personal import scheme. A company or a person may claim that they can arrange the supply of an unapproved medical device provided the unapproved device is supplied legally. Note that ‘advertising’, as defined in the Therapeutic Goods Advertising Code 2018, is not the same as making ‘claims about arranging supplies of medical devices’.
To learn more about the Australian Regulatory Guidelines for Advertising Therapeutic Goods, please visit the TGA website.