Australia: Advertisers Slapped With Infringement Notices For Non-Compliant Advertising Of Therapeutic Goods

Last Updated: 13 September 2019
Article by Mandi Jacobson, Danielle Kuti and Angell Zhang

Advertisers are reminded the Therapeutic Goods Advertising Code 2018 (TGAC) was recently amended by the Therapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument 2019. The amendments came into effect on 30 July 2019. This is particularly important given the TGA continues to crack down on non-compliant advertising.

What should you look out for?

Advertising prescription only medicines or therapeutic goods that are not listed or registered on the Australian Register of Therapeutic Goods (ARTG) are some of the most common offences.

Indeed, on 10 September 2019:

  1. PharmaCare paid a fine of AU$12600 for advertising its 'Sambucol Cold & Flu Kids Liquid' product which had previously been cancelled from the ARTG (the reason for its cancellation from the ARTG was due to its initial application for inclusion on the ARTG being false or misleading).
  2. Redback SARMs paid fines in the amount of AU$15210 after the TGA issued six infringement notices for non-compliant advertising of prescription only medicines.

Other offences include advertising restricted or prohibited representations without approval or permission from the TGA.

Review your marketing material

In light of the recent amendments to the TGAC, we recommend advertisers review their marketing material to ensure compliance with the updated TGAC, particularly in relation to mandatory health warning statements.

The key amendments to the TGAC include:

  • A change to the general rules of advertisements to clarify that, for the purposes of section 13, the test for whether there is a health warning for a medicine is limited to the inclusion of an ingredient listed in Part 1 or Part 2 of Schedule 1 (Medicine ingredients with specific health warnings).
  • Clarification that the general rules of advertisements do not apply to advertisements for therapeutic goods containing only the name of the goods, a pack shot image of the goods or the price of the goods so long as no therapeutic claims are visible or implied.
  • Clarification that advertisers may either use the indication or intended purpose as it is set out on the good's label or primary packaging, or, alternatively, modify the indication or intended purpose in a manner that does not change the meaning or intent of the indication or intended purpose, as it appears on the label or packaging.
  • With respect to restricted representations, clarification that a serious form of a disease, condition, ailment or defect does not include pregnancy, other than pregnancy with a medical, obstetric or surgical condition.

About Dentons

Dentons is the world's first polycentric global law firm. A top 20 firm on the Acritas 2015 Global Elite Brand Index, the Firm is committed to challenging the status quo in delivering consistent and uncompromising quality and value in new and inventive ways. Driven to provide clients a competitive edge, and connected to the communities where its clients want to do business, Dentons knows that understanding local cultures is crucial to successfully completing a deal, resolving a dispute or solving a business challenge. Now the world's largest law firm, Dentons' global team builds agile, tailored solutions to meet the local, national and global needs of private and public clients of any size in more than 125 locations serving 50-plus countries. www.dentons.com.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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