Product commercialization and the Therapeutic Goods Administration: a reminder to exercise caution when advertising therapeutic goods

The Therapeutic Goods Advertising Code (the Code), is administered by the Therapeutic Goods Administration (TGA), and ensures that therapeutic goods are marketed and advertised responsibly, in a way that does not mislead or deceive consumers. Recently, amendments were made to the Code and on 30 July 2019, the Therapeutic Goods Advertising Code (No 2) 2018 came into effect.

Key changes
•The definition of “health warnings” has been clarified, as applied to medical devices and other therapeutic goods.
•Advertisers have more flexibility in terms of the wording used when describing indications or intended use of a product.
•There is also more flexibility when advertising therapeutic goods that contain only the name, picture, price of the goods or where these may be purchased, or a combination of these. Full details of the amendments can be found on the TGA website (1).

Since these amendments came into force, the Department of Health, through the TGA, has been active in monitoring commercial activities, and has sought prosecution of a number of businesses who have allegedly failed to comply with the Code. One example is outlined below.

Secretary Department of Health v Peptide Clinics Australia Pty Ltd [2019] FCA 1107 (Peptide Clinics)
In Peptide Clinics, the Department of Health was successful in its Federal Court proceedings against Peptide Clinics Australia for breach of the Code. On 23 July 2019, Peptide Clinics was ordered to pay a penalty of $10 million for advertising a peptide product that breached the Code and advertisement restrictions. Peptide Clinics was found to have advertised a prescription medicine on social media, the internet and on the telephone, as being safe to use and that medical practitioners were in support of its commercial sales. It was found that the information was misleading. In particular, the Court held that medical questionnaires reviewed by medical practitioners, which were then followed up with telephone consultations, did not offer the minimum standard of care that should be delivered by medical professionals when treating patients.

The Federal Court held that Peptide Clinics, through a deliberate marketing strategy, had sought to pursue financial gain at the expense of public health and safety and legal obligations, despite repeated concerns raised by the TGA. As such, Peptide Clinics was found to be in breach of the Code.

Lessons to be learnt
The Peptide Clinic case is only one of several cases prosecuted by the Department of Health. What we can learn from this case is that:

•The Department of Health, through the TGA, is active in regulating the therapeutic goods industry.
•Businesses that fail to comply with the Code are at risk of receiving financial penalties, which may be accompanied with the serving of infringement notices, criminal charges or the commencement of civil court proceedings (2).
•Advertising of therapeutic goods on informal interfaces, such as on websites or on social media, in particular where users may be able to review and select prescription-only medicines for use and/or supply, are considered as advertisements of the relevant therapeutic good.
•Other false representations, in particular those that make reference to the health and medical professionals, should be carefully considered, since such assertions may be misleading to the public and may have detrimental effects to public health.

Thus, in light of the stronger compliance and enforcement powers of the TGA, we highly recommend that all suppliers of therapeutic goods in Australia familiarize themselves with the latest standards and regulations.


This article was written by Dr Vanessa Yeung.

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Jones Tulloch’s articles are provided as general information only, current at the date of publication. They do not constitute professional (patent and trade mark attorney) advice and should not be relied upon as such. If you need specific professional advice, for example in relation to a matter of interest arising from this communication, please contact us.