News & Insights

On 1 January 2019, the Therapeutic Goods Advertising Code 2018 (the 2018 Code) took effect, replacing the 2015 Code.

If an advertisement was compliant with the 2015 Code, this does not automatically mean it complies with the 2018 Code. There are a number of differences between the two codes.

Whilst the Therapeutic Goods Administration (TGA) has said it will take a pragmatic approach to any complaints relating to advertisements being in breach of the 2018 Code which are received between 1 January 2019 and 30 June 2019, the 2018 Code is legally effective on and from 1 January 2019.

Therapeutic Goods are those products for human use that prevent, diagnose, cure, alleviate a disease, ailment, defect or injury, influence a physiological process, test a person’s susceptibility to a disease or ailment, influence, control or prevent conception or test for pregnancy. These goods can include the ingredients or components of those goods and containers for goods of the kind described above (section 3 Therapeutic Goods Act 1989).

Penalties

Penalties for breaching the 2018 Code include enforceable undertakings, warning letters, directions, public warning notices and sending educational letters, as well as civil and criminal proceedings and fines.

The TGA may issue an infringement notice with a maximum of 12 penalty units, equating to a fine of up to $2,520 for an individual and $12,600 for an incorporated body.

If convicted by a court for non-compliant advertising, penalties include:

• up to 5 years imprisonment or 4000 penalty units (currently $840,000) could be faced where harm or injury to a person were proved;
• up to 12 months imprisonment and/or 1000 penalty points (currently $210,000); or
• 100 penalty points (currently $21,000).

If a corporation commits the offences, a 5 x multiplier may be applied.

Key changes

According to the TGA, the 2018 Code seeks to ensure advertising and marketing of therapeutic goods is ethical, promotes quality use of the goods and does not mislead or deceive the public.

The key changes introduced by the 2018 Code are:

• Greater clarity on:
  • what it means for health warnings to be “prominently displayed or communicated” to be compliant with the 2018 Code and Therapeutic Goods Regulations;
  • what health warnings must be in relation to certain ingredients; and
  • who the 2018 Code applies to (any person who advertises or causes the advertising);
• More objective tests to support sanctions and penalties;
• What advertisements must contain;
• Endorsements of any kind must not be included on advertisements such as  endorsements from any government agency, hospital or other such facility;
• Comparative advertisements must not claim or imply that comparators are harmful or ineffective;
• All advertising (save for key public health items such as sunscreen or condoms) must not include the offer of a sample;
• Certain key information must be in an advertisement where the product is not available for physical examination at the time of purchase i.e. where it is purchased online;
• Where there is a distinction between scientific claims and scientific representations, the research must be identified or cited in advertisements;
• If a complementary medicine includes a claim based on evidence of a history of traditional use, it must disclose the reliance on that traditional use with such disclosure being displayed or communicated in the advertisement;  and
• Advertising to children under the age of 12 is prohibited and only certain goods, as listed in Schedule 2 of the 2018 Code may be advertised to those under the age of 18.

Top tips issued from the TGA to avoid advertising complaints

•  Ensure advertisements contain:
  • the correct mandatory statements; and
  • information with appropriate prominence.
• Check advertising for complementary medicines to ensure full compliance with express provisions;
• Ensure testimonials, endorsements and scientific representations comply with clarified requirements under the 2018 Code;
• Do NOT use advertising:
  • with references to diseases, conditions or ailments before checking if you need restricted representation approval;
  • that is inconsistent with a products entry on the Australian Register of Therapeutic Goods, directions or instructions;
  • that encourages people to delay seeking medical advice or stop prescribed therapies; or
  • that conflicts with public health campaigns.

If you need assistance in ensuring compliance with the 2018 Code please contact one of our lawyers in our Commercial team.

This article was written by Eloise Preller, Associate – Commercial.