Australia: Pre-Approval for Australian Advertisements of Therapeutic Goods Abolished

The TGA will continue to regulate the advertising of therapeutic goods and advertisers must continue to ensure that they are fully compliant with the Therapeutic Goods Act 1989 (TG Act) and the Therapeutic Goods Advertising Code. Advertisers making "restricted representations" in their advertisements, such as a reference to a serious form of a disease, must still seek pre-approval from the TGA. Importantly, any reference to COVID-19 is a restricted representation.

Despite the removal of this pre-approval requirement, the TGA remains vigilant and active in enforcing the advertising requirements for therapeutic goods. Since January 2020, the TGA has issued 15 fines totalling $1,151,640 for unlawful advertising.

• In June, the TGA issued 5 infringement notices totalling $63,000 to Chemforce Pty Ltd for advertising a medicine called RibaMin that is not included on the Australian Register of Therapeutic Goods. The company contravened the TG Act by making a restricted representation that RibaMin is an effective treatment for COVID-19, implying that the product was approved or endorsed by the US FDA and stating that the good was safe.
• In June, the TGA issued 17 infringement notices totalling $214,200 to Net Pharmacy Pty Ltd for its unlawful online advertisements for prescription only medicines, which are prohibited from being advertised to the general public. The company was also fined for promoting the use of stem cells on its website, which is a regulated biological, and cannot be advertised to the public, and for making restricted representations in relation to cardiovascular disease.
• In May, the TGA fined Southern Cross Directories Pty Ltd $151,200 for unlawful advertisements of its Miracle Mineral Supplement. The company made unproven claims that its product cures, prevents or alleviates a number of diseases, including COVID-19. The TGA also issued a safety alert to consumers in relation to the use of the Miracle Mineral Supplement. MMS Australia did not remove the contravening advertisements after receiving the TGA's infringement notices and the TGA has since commenced Court proceedings against MMS Australia and its sole director.

In addition to maintaining a watchful eye over the advertisement of therapeutic goods, the TGA have also published a consumer guide titled "How to spot a dodgy health product ad" and encouraged consumers to report advertisements for therapeutic goods that they think break the law.

To ensure that you are not on the receiving end of an infringement notice from the TGA, advertisers of therapeutic goods should have in place comprehensive self-review processes for advertisements prior to publication.  Regular training of relevant employees in relation to the relevant provisions of TG Act, the Therapeutic Goods Advertising Code and the Australian Consumer Law are also imperative.