General advertising offences are contained in section 42DL of the Therapeutic Goods Act 1989 (the TG Act). Previously, section 42DL stated it was an offence for a person to ‘publish’ or ‘broadcast’ an advertisement about therapeutic goods under certain circumstances. The Therapeutic Goods Amendment (2017 Measures No.1) Act 2018 (Amendment Act), previously discussed here, has repealed these offence provisions and replaces it with a new tiered offence regime. The Amendment Act received Royal Assent on 5 March 2018.

What are the changes?

The Amendment Act introduces a new tiered offence regime to the general advertising offences under section 42DL of the TG Act, being:

  • a high level offence that consists of the prohibited conduct, an aggravated element and a nexus element (i.e. the use of the therapeutic good in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or the use of the therapeutic good in reliance on the advertisement, if the goods were so used, would result in or would be likely to result in, harm or injury to any person). This carries a penalty of $840,000 or imprisonment for 5 years, or both;
  • an ordinary offence attracting a maximum penalty of $210,000 or imprisonment for 12 months, or both; and
  • a strict liability offence within the meaning of the Criminal Code, attracting a maximum penalty of $21,000.

Previously, the penalty for a contravention of section 42DL was $12,600.

Contravening provisions

Contravening activities captured under the tiered offence regime includes where a person advertises, by any means, therapeutic goods, or causes the advertising, by any means, of therapeutic goods and the advertisement contains, for example (among other things):

  • prohibited representations;
  • restricted representations;
  • references to substances included in Schedules 3,4 or 8 of the Poisons Standard (but not in Appendix H of the current Poisons Standard ‘Poisons permitted to be advertised’); and
  • goods that are not entered into the Australian Register of Therapeutic Goods (ARTG) (subject to certain exclusions).

Civil penalties

The Amendment Act also introduces civil penalties corresponding to the tiered offence provisions provided for under section 42DL. For example, advertising therapeutic goods that are not entered into the ARTG attracts a maximum penalty of $1,050,000 for an individual and $10,500,000 for a body corporate. Exceptions apply.

The Amendment Act also introduces continuing offences under the new subsections 42DL(13), 42DL(14), 42DM(5) and 42DM(6). A person commits a separate offence for each day during which the contravention continues. For each day, there is a maximum penalty of 10% of the maximum pecuniary penalty that can be imposed in respect of that offence.

What does this mean for you?

The continuing offence provisions reflect the increased use of advertising therapeutic goods through electronic means, such as on the internet, as opposed to the traditional methods of publications in newspapers and magazines.

It is important for companies who have received confirmation or warning that they have contravened an advertising provision to take action immediately, particularly, given increased penalties and the new continuing offence provisions.