Increasing enforcement by the TGA: are you complying with advertising requirements?

28 June 2024

Recently, the Therapeutic Goods Administration (TGA) seems to have been very active in its monitoring of the advertising of therapeutic goods and taking enforcement action, particularly against businesses promoting prescription medicines.

All advertising of therapeutic goods to the public must comply with the requirements of the Therapeutic Goods Act 1989 (Cth) (TG Act), Therapeutic Goods Regulations 1990 (Cth) (TG Regulations) and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (Cth) (Code).

As therapeutic goods are generally used to influence the health conditions of individuals, they have more onerous advertising requirements than the advertising of general household goods as individuals may be more vulnerable and not able to impartially judge certain advertising claims due to their health concerns.

We provide a brief overview of the advertising restrictions below.

What are the rules?

What is a therapeutic good?

A therapeutic good is determined by the ingredients in the good as well as the claims that are made about it ie whether a claim is made that the good has a therapeutic use.

Can you advertise therapeutic goods?

Whether or not a therapeutic good can be advertised depends on a number of things including what it is, what is in it, how it works and what you want to say about it. Therapeutic good must generally either be included in the Australian Register of Therapeutic Goods (ARTG) or be exempt, before they can be advertised or sold in Australia.

However, some therapeutic goods cannot be advertised to the public and this includes prescription medicines and pharmacy only medicines.

What is ‘advertising’ under the TG Act?

Advertising in relation to therapeutic goods is defined in s3(1) of the TG Act as:

“any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:

 (a) is on the label of the goods; or

 (b) is on the package in which the goods are contained; or

 (c) is on any material included with the package in which the goods are contained.

Therefore, it includes articles published in magazines and newspapers as well as films, photographs and videos which include statements or images intended to promote the goods.

What about medical devices?

Medical devices can also generally be advertised if they are included in the ARTG, exempt from ARTG inclusion as they are custom-made or they are a patient-matched medical device that is not included in the ARTG, provided a transition notification has been submitted.

However, medical devices that are advertised to the public must not include any “restricted representations” or “prohibited representations” in an advertisement.

What are “restricted representations”?

A restricted representation is a “representation in an advertisement about therapeutic goods that refers to a form of a disease, condition, ailment or defect identified in a part of the Therapeutic Goods Advertising Code as a serious form of a disease, condition, ailment or defect.”

An application for the approval of the use of a restricted representation can be made to the TGA if it is in writing and in the approved form.

What are “prohibited representations”?

It is also an offence to advertise therapeutic goods using prohibited representations. Prohibited representations include:

“(a) a representation regarding abortifacient action;

(b) a representation regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or predisposition to, one or more of the following:

(i) neoplastic disease;

(ii) sexually transmitted diseases;

(iii) human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);

(iv) hepatitis C virus (HCV); and

(v) mental illness”.

Other prohibited representations apply to particular types of therapeutic goods, including analgesics, disinfectants and antiseptics, and vitamins and minerals.

As opposed to restricted representations, applications cannot be made to the TGA seeking approval of use of a prohibited representation.

What are the penalties?

The penalty depends on whether the “use of the goods in reliance on the [contravening] advertisement has resulted in… or is likely to result in, harm or injury to any person”.

If the use of the goods is likely to result in harm, the maximum penalty is currently imprisonment for 5 years or $1,252,000 or both. If the use of the goods is unlikely to cause harm, the maximum penalty is currently imprisonment for 12 months or $313,000 or both.

The civil penalty provision can result in fines of up to $15,650,000 for a corporation and $1,565,000 for an individual.

Are there any exceptions?

Under the TG Act, the TGA “may, by writing, permit the use of specified restricted representations in specified advertisements about specified therapeutic goods.” Additionally, the TGA “may, by writing, permit the use of specified prohibited representations in specified advertisements about specified therapeutic goods if the Secretary is satisfied that the representations are necessary in the interests of public health“.

Permissions given by the TGA are published on the TGA Department’s website.

Self-Regulation

As it is up to each business to ensure their own compliance with the TGA Act, TG Regulations and the Code, businesses need to be vigilant in checking that all forms of promotion and advertising of any therapeutic goods and medical devices satisfy the requirement for advertising to avoid significant penalties. Please contact us if you would like our assistance.

This article was written by Jennifer Huby, Partner and Kirsten Schreuder, Solicitor.

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