A series of recent enforcement actions and announcements by the Therapeutic Goods Administration (TGA) indicate that the regulator is actively monitoring and prosecuting businesses for breaches of the Therapeutic Goods Advertising Code (No. 2) 2018 (TG Advertising Code) and Therapeutic Goods Act 1989 (TG Act).
These enforcement actions include:
- successfully prosecuting a business in the Federal Court of Australia, resulting in a financial penalty of AUD 10 million, for advertising peptide products:
- in breach of restrictions on advertising substances listed in Schedule 4 of the Standard for the Uniform Scheduling of Medicines and Poisons (Poisons Standard), including peptide products;
- making claims which breach the TG Advertising Code, including:
- prohibited and restricted representations in relation to treatment of certain serious conditions;
- that the products are safe and do not cause harm to users; and
- encouraging inappropriate use by providing incorrect information about the indications (uses) of the products; and
- misleading consumers that medical practitioners were involved in the business;
- announcing a targeted investigation into the advertising of ‘bioresonance’ medical devices (which measure human emission of electromagnetic waves) as a means of detecting and treating serious ailments, diseases and conditions; and
- issuing two individuals with infringement notices for the importation and advertising of performance and image enhancing products that were not listed on the Australian Register of Therapeutic Goods (ARTG).
Given that the TGA can bring civil and criminal prosecutions for breaches of the TG Advertising Code, these matters come as a timely reminder for businesses to ensure they comply with their obligations under this code and, more broadly, the TG Act.
From these enforcement activities, the key takeaways for businesses advertising therapeutic goods in Australia are that:
- businesses should not advertise:
- therapeutic goods that are not listed on the ARTG; or
- prescription-only drugs listed on the ARTG or substances contained in Schedule 4 of the Poisons Standard to consumers;
- advertisements should comply with the TG Advertising Code, namely:
- they should accurately state the indications (uses) of the therapeutic good;
- they should not make claims that a product has no side effects, especially when this is known not to be the case;
- they should not make restricted representations, including claims in relation to treating serious forms of a disease, condition, ailment or defect, such as conditions that are:
- medically accepted to require diagnosis or treatment or supervision by a suitably qualified health professional; or
- there is a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available for the form (including a self-
administered test), which requires medical interpretation or follow-up;
- from an enforcement perspective:
- even where therapeutic goods are advertised by reference to an informal or non-scientific name, the TGA will consider it to be an advertisement of the relevant therapeutic good; and
- in assessing penalties, fines for conduct will be calculated per day, for each day that the non-compliant advertising appears on the relevant medium
(including on websites and social media).
For advice on the advertising of therapeutic goods in Australia, please contact Melinda Upton and Greg Bodulovic (Special Counsel).
This post was co-authored by Matthew Rozario (Paralegal), Valiant Warzecha, Greg Bodulovic (Special Counsel) and Melinda Upton.