Advertisers beware! TGA advertising guidance updated ahead of transition period ending

Dean Gerakiteys, Natalie Coulton
09 Jun 2022
Time to read: 3 minutes

With less than one month remaining of the transition period between the 2018 TGA Advertising Code and 2021 TGA Advertising Code, the TGA has provided some helpful guidance on how the new Code will apply.

As we reported earlier this year, the TGA has introduced the new Therapeutic Goods Advertising Code 2021 (2021 Code) which is intended to replace the 2018 version of the Code. While the 2021 Code came into effect from 1 January 2022, advertisers were given a 6 month transition period to ensure advertising was compliant with the 2021 Code. That transition period is due to expire on 30 June 2022, meaning advertisers have just under a month to ensure their advertisements are compliant with the 2021 Code.

What has changed with the Advertising Code?

As a reminder the main changes are:

  1. Simplifying mandatory statement requirements for therapeutic goods and reducing the number of required mandatory statements (see Part 4 of the 2021 Code);
  2. Clarifications to the rules regarding testimonials and endorsements in advertising (see Part 6 of the 2021 Code);
  3. Increasing the types of therapeutic goods that can be offered as samples (see Part 7 of the 2021 Code); and
  4. Expanding the rules for "safe and proper use" (see section 9 of the 2021 Code).

Updated TGA guidance on the approach to the 2021 Code including in relation to Testimonials and Endorsements

The TGA has since provided guidance on applying the Advertising Code rules together with specific guidance on the use of testimonials and endorsements. While the former provides some helpful insight for sponsors into how the TGA will approach the updated parts of the 2021 Code, the latter is especially relevant to sponsors who seek to engage influencers to assist with the marketing of their therapeutic goods.

The key distinction is that while testimonials are considered to be a type of endorsement, not every endorsement will be a testimonial. As the TGA has helpfully indicated, an endorsement will contain some support or approval in relation to a therapeutic good, while a testimonial contains a statement about a therapeutic good made by a person who claims to have used the good or who has used the good while caring for another.

There are restrictions that apply to both testimonials and endorsements, namely neither is permitted to:

  • contravene the provisions of the 2021 Code;
  • contain information which is inconsistent with the information provided with the product or on its label;
  • contain statements which are inconsistent with the indications or intended purpose as noted in the ARTG entry for the therapeutic goods; and
  • contain statements about health benefits other than the typical health benefits expected from use of the goods as directed.

Notable prohibited persons for both testimonials and endorsements include current or former health practitioners, health professionals or medical researchers and hospitals or healthcare facilities other than community pharmacies.

Specifically with respect to testimonials, the guidance includes a reminder that testimonials are required to be verified by advertisers (including as to the testimonial maker's identity and the content of the testimonial). Importantly, the guidance also notes that any links to other websites or information included with a testimonial is considered part of the testimonial, and therefore the subject of these verification requirements.

With respect to valuable consideration, the guidance notes that providing free products to a testimonial maker is valuable consideration except where the free product is provided as a product sample, with some illustrative examples given.

A separate section addresses testimonials made by influencers, bloggers and brand ambassadors, which notes that any testimonial given by such persons is not permitted to be used in advertising for therapeutic goods.

However, there is no blanket ban on influencers, bloggers or brand ambassadors providing endorsements, provided they do not otherwise fall within the list of prohibited persons for endorsements. The guidance includes a general reminder of the requirement for advertisements of therapeutic goods to not mislead consumers and for the receipt of valuable consideration to be disclosed in an endorsement, for example through use of the phrase "paid partnership".

Ensuring compliance with the Therapeutic Goods Advertising Code 2021

The 2021 Code came into effect on 1 January 2022. Although the TGA allowed for a 6 month transition period, from 1 July 2022 all advertisers will need to ensure they comply with the 2021 Code. Given the breadth of the TGA's guidance on the changes to the Code and in particular the of testimonials and endorsements, sponsors should be wary.

The 2021 Code came into effect on 1 January 2022. The transitional period that was in place applies only until 30 June 2022. From 1 July 2022 sponsors will no longer have the option of complying with either the 2021 Code or the 2018 Code. From 1 July 2022, advertisers must ensure that therapeutic goods advertising complies with the requirements of the 2021 Code.

Please contact Clayton Utz if you would like any assistance or advice relating to the advertising of therapeutic goods or compliance with the Code.

Clayton Utz communications are intended to provide commentary and general information. They should not be relied upon as legal advice. Formal legal advice should be sought in particular transactions or on matters of interest arising from this communication. Persons listed may not be admitted in all States and Territories.