By Dr Teresa Nicoletti, Partner and Helaena Short, Lawyer

Several reforms to the advertising framework for therapeutic goods have commenced. Among these, a new Therapeutic Goods Advertising Code has been introduced. The new Code seeks to simplify the minimum standards for all medicine and medical device advertisements which are directed at the public. Importantly, however, despite expectations that the new Code would commence on 1 July 2018, sponsors and advertisers will be given additional time to contemplate the new Code and ensure their advertisements are up to scratch before 2019. Partner, Dr Teresa Nicoletti and Lawyer, Helaena Short discuss.

The Therapeutic Goods Advertising Code (Code) is a legislative instrument made under section 42BAA of the Act, which defines the minimum requirements for all advertising of therapeutic goods to the public. Since 2007, the Code has not undergone any significant changes, however, after consultation earlier this year, a considerably amended version of the Code was introduced on 29 June 2018 and will commence on 1 January 2019 (New Code).
Relevantly, the New Code seeks to implement the recommendations of the Sansom Review and ensure that all therapeutic goods are marketed and advertised in a manner that promotes safe and effective use, is ethical and not misleading or deceptive, supports informed health care choices and is consistent with current public health campaigns.

The specific differences between the New Code and the existing version are intended to simplify the requirements, improve advertiser understanding, address any existing inconsistencies (particularly between medicines and medical devices) and provide more objective tests to determine breaches of the Code. The amendments are thus not only intended to improve the accessibility and application of the New Code in isolation but also to improve the function of the regulatory framework for the advertising of therapeutic goods more generally i.e. in conjunction with, for example, the new penalties and sanctions, and revised complaints handling process.

Comparison between the existing Code (2015) and the new Code (2018)

The differences between the existing Code and the consultation draft of the New Code are comprehensively summarised in a chart published by the TGA here.

The most significant changes are summarised below.

1. Display of statements: In relation to statements that are contained in a therapeutic goods advertisement, the New Code distinguishes between, and provides definitions for, “displayed or communicated” and “prominently displayed or communicated”. In this way, the New Code seeks to ensure that only messages critical to the consumer when selecting a product for self treatment need to be ‘prominently displayed’.
   Among others, sections 11, 12 and 13 of the New Code provide further guidance on those statements which must be displayed or communicated, prominently or otherwise, in various therapeutic good advertisements. Notably, there are some novel requirements; for example, that advertisers must provide information about where a consumer can obtain further important information about a good (in applicable advertisements) and a mandatory allergy warning must be prominently stated in advertisements for some therapeutic goods.
2. Comparative advertising: Subsection 4(5) of the existing Code has been removed and comparative advertising is covered elsewhere in the New Code. In any event, comparative advertisements for therapeutic goods must not claim or imply that comparators are harmful or ineffectual, and further guidance on the acceptable use of comparisons will be provided in the Code guidelines.
3. Samples: Subsection 4(8) of the existing Code has been removed and, accordingly, all advertising must not include the offer of a sample of a therapeutic good, with the exception of key public health items (e.g. sunscreens, condoms).
4. Internet advertising: Section 12 of the New Code applies to direct marketing and internet marketing and prescribes the information which must be contained in an advertisement in circumstances where a physical product is not available for examination at the time of purchase. These requirements apply equally to medicines and medical devices.
5. Scientific research and claims: Section 15 of the New Code is equivalent to sub-section 4(4) of the existing Code. However, notably, TGA has proposed providing further guidance on the distinction between scientific claims and scientific representations, and in what circumstances specific research must be identified and/or cited in a therapeutic goods advertisement.
6. Testimonials and endorsements: Section 16 of the New Code is intended to replace paragraphs 4(6)(a) to (c) of the existing Code and confirms that endorsements of any kind must not be included in therapeutic goods advertisements. Notably, endorsement as described in this section is intended to include advertisements that reference sponsorship of any government agency, hospital or other facility providing healthcare services. Section 17 replaces the existing subsection 4(7) and provides further clarity on using genuine testimonials, including the persons who may be involved and the information which must be disclosed in any therapeutic goods advertisement.
7. Restricted and prohibited representations: Section 28 of the New Code simplifies and clarifies what representations are restricted and, in conjunction with the new section 29 (which replaces the existing Part 2 of Appendix 6), when such representations may be used in the public interest. Section 30 replaces Part 2 of Appendix 6 and specifies what representations are prohibited. The exception has been removed from the Code as the relevant power now resides in section 42DK of the Act, which empowers the Secretary to permit the use of specified prohibited representations in specified advertisements about particular therapeutic goods, where it is in the interests of public health.
8. Evidence of traditional use: Section 23 of the New Code is a novel provision which requires any advertisement for a complementary medicine which includes a claim based on evidence of a history of traditional use and paradigm to disclose the reliance on such traditional use. The disclosure must be displayed or communicated in the advertisement.
9. Advertising to children: The New Code clarifies the requirements for advertising which is directed primarily to children, including a list of goods that may be advertised to children in Schedule 2. A ‘child’ is defined to include any person under the age of 18.

What does the New Code mean for you?

The Code applies to the advertising of any therapeutic good to the public. It affects the marketing and advertising activities of sponsors of OTC and complementary medicines, and some medical devices, which are entered in the Australian Register of Therapeutic Goods.

Notably, ‘advertise’ under the Act is defined to include the making of any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods. Accordingly, any person, including third parties advertising at arms length in certain media (such as in social media or podcasts), may be affected by the requirements of the Code if they engage in any visual presentation or dialogue which may be construed as promoting the use or supply of a therapeutic good.

Notably, however, the Code does not apply to the advertising of all therapeutic goods. For example, the Code does not apply to prescription only medicines or unapproved therapeutic goods (the advertisement of which is prohibited to the general public). Furthermore, the Code does not apply to advertising specified under section 42AA of the Act, including advertising by some practitioners and other persons.

Although the new Code was anticipated to take effect on 1 July 2018, in response to stakeholder demand, the TGA has now proposed a 6 month transition period whereby the new Code will not take effect until 1 January 2019. This gives industry participants adequate time to consider and become familiar with the new Code and amend their advertising accordingly. To assist with the transition, the TGA proposes to provide a series of educational materials and opportunities (e.g. webinars and an online training program) to communicate the requirements for all advertisers in a clear and accessible way.

Concluding remarks

The New Code seeks to ensure that the Australian public has access to the highest quality information about medicines and medical devices which is important for consumers to make informed decisions about their purchases and health. It clarifies the minimum requirements for advertising to the public and, with the TGA’s promised efforts to educate sponsors and other advertisers, the New Code represents another step forward for the industry. We appreciate the challenges which sponsors and advertisers may face over the transition period, but are confident that the New Code has the potential to improve the quality and clarity of therapeutic goods advertising for all Australians.