Consultation: Regulatory options to allow references to the TGA in therapeutic goods advertising

We asked for feedback on potential regulatory options to allow advertisers, including product sponsors, to make references to the TGA in advertising (including on product labels).

We sought feedback on:

• whether references to the TGA should be allowed in therapeutic goods advertising
• the class or classes of therapeutic goods, if any, that should be allowed to refer to the TGA
• options for what a reference to the TGA could look like
• options for how an authorised reference to the TGA may be used in advertising
• whether references to the TGA should be optional or mandatory for advertisers.

A total of 26 submissions were received from the therapeutic goods industry (sponsors, manufacturers and industry organisations), healthcare professional bodies, consumers, consumer representatives and advertising organisations.

Overall, there was limited support for broadly allowing references to the TGA in advertising.

Around half of the respondents expressed moderate support for some regulatory change however of those most were of the view that this should be limited to certain types of products only. Even among those supportive of regulatory change, there was concern about the potential for consumers to misinterpret and/or be misled about the meaning of the reference to the TGA.

Respondents also raised concerns about:

• potential costs for industry relating to label changes, and international harmonisation of labels
• potential to mislead consumers in relation to the level of evaluation the product had undergone if the scheme applied to products such as complementary medicines and class I medical devices
• the potential for an unfair advantage when one product included the reference to the TGA, and a competitor product did not (when both had been subject to the same regulatory processes).

A strong majority of respondents agreed that, should regulatory changes be implemented, use of references to the TGA should not be mandatory for advertisers.

Several respondents suggested that allowing references to the TGA could be most useful in less typical situations, such as the circumstances around COVID‐19 rapid antigen tests when they first became available for home-use. In this situation health professionals and consumers were in need of information to assure them that the particular product had been TGA approved for supply. This option would see the TGA issuing an authorisation to allow references to the TGA only in particular circumstances with limiting conditions (for example for a particular product type and with a specified reference).

Based on the outcomes of consultation, agreement was sought from the Government on the options.

The Government has decided to allow the TGA to authorise advertisers of certain products in certain circumstances to make reference to the TGA in advertising in response to public health needs. This will be determined on a case-by-case basis by the TGA.

There are existing legal mechanisms the Therapeutic Goods Act 1989 that allow this to be implemented.