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Advertising to the public
Complying with the Therapeutic Goods Advertising Code (No. 2) 2018
Part 1 - Preliminary
Guidance on specific Code provisions
The numbering of the sections corresponds to the numbering of the Code provisions for ease of cross-reference. However, this guidance does not cover all sections of the Code so the numbering may not be sequential.
The Code is effective from 1 January 2019. However Part 4 of Schedule 1 of the Code does not commence until 1ST of September 2020.
A consolidated list of definitions from the Act, the Regulations, the Code and any other legislative instruments that are relevant to the Code is provided.
The object outlines the underlying purposes of the Code.
The object reflects the responsibility that advertisers have to ensure that the content and presentation of their advertisement promotes responsible use of therapeutic goods through encouraging consumers to select management options wisely, to choose suitable therapeutic goods and to use them safely and effectively.
Generally, in applying this Code to an advertisement, advertisers should take into account the Code's object to protect public health by ensuring therapeutic goods are honestly promoted as to their benefits, uses and effects.
6(1) Code applies to the advertising of therapeutic goods
The Code applies to the advertising of therapeutic goods, except for:
- content that is outside of TGA's jurisdiction
- advertising directed exclusively to health professionals
- genuine news in particular situations
The Code does not apply to the advertising of products that are not therapeutic goods, including food and cosmetics. However, making therapeutic claims in advertising for such products may in some circumstances make these products a therapeutic good. See the Australian Regulatory Guidelines on Advertising Therapeutic Goods for more information on these "interface products".
Public health messages that do not promote an identifiable therapeutic good (for example, mammography services, or vaccination services) are not advertisements for therapeutic goods. Disease awareness initiatives that may be undertaken by companies to encourage consumers to seek health professional advice in relation to certain health symptoms are also unlikely to be considered advertisements for therapeutic goods (in cases where no product is identifiable).
The marketing of therapeutic goods can include the name of the good, the name and logo of the sponsor and tag lines or catch-phrases which are often used in a similar fashion to logos to identify a good or advertising as belonging to the sponsor. Similarly, a range of goods may have a common or 'umbrella' name or brand to tie them together and differentiate them from similar ranges of goods marketed by competitors. Depending on the nature and context of these elements when used within advertising of therapeutic goods, they may be interpreted as claims about the advertised therapeutic goods.
Further information on Forms an advertisement may take is available in the ARGATG.
Therapeutic goods advertising material posted on a website owned by or registered to an Australian entity, or where the contact for the website is an Australian individual or corporate entity (Australian websites) are subject to the Act and the Code. Overseas websites containing material promoting therapeutic goods that are linked to or where the entered URL for these websites redirects the user to another website, or promotional material incorporated by any other means into an Australian website must either be compliant with the Code or the link, content or redirection must be removed from the Australian website.
6(2) Advertisements exclusively to health professionals
The Code applies to all advertising of therapeutic goods to the public. Advertisements directed exclusively to health professionals (within the meaning of s.42AA of the Act) are not subject to the requirements of the Code. See Definitions for more information on the types of health professionals that are subject to this exemption.
Directing advertising exclusively to health professionals
In order for an advertisement to be considered to be directed exclusively to health professionals, the content must not be available to consumers at all. For example:
- content provided online for health professional should be secured in some way to ensure that it can only be accessed by those persons who are listed as health professionals under section 42AA of the Act. The mechanism for achieving this outcome is up to individual advertisers and could include having the material password protected, and/or by a declaration that the user is a healthcare professional and/or by a requirement to provide a current healthcare professional (AHPRA) registration number.
- content provided via email should only be provided once the professional credentials (e.g. AHPRA or other accreditation) of the individual has been established
- an advertisement that appears in magazine directed to a specific health professional group such as the Australian Journal of Pharmacy or Australian Doctor
Factual information (for example scientific/medical information) meant for health professionals does not need to be secured provided that it is not directly or indirectly promotional. For example, a medicines sponsor website that provides access to product information documents for all of their prescription medicines that is accessed via an index ordered solely by medicine name would be unlikely to be considered promotional. However, providing broad public access to the same documents via an index grouped by medical condition, or allowing searching of such documents by medical conditions would be considered promotional. Providing factual information publically in other promotional contexts may also result in that information being considered part of an advertisement to the public.
6(3) Impact on reasonable person to whom the advertisement is directed
This section requires the Code to be applied to an advertisement by reference to its likely impact on a reasonable person to whom the advertisement is directed.
Therapeutic goods differ from normal consumer goods. Consumers are making choices about their health and considering goods that are intended to have a therapeutic effect. In some cases, this may place them in a more vulnerable position than if they were making choices about ordinary consumer items. There are additional requirements for advertising therapeutic goods over and above Australian Consumer Law in recognition of the potential vulnerability of consumers who may have limited capacity to properly evaluate the information presented in advertisements.
Therefore, advertisers should be aware that a 'reasonable person' for the purposes of the application of the Code may include a consumer of therapeutic goods who may be more vulnerable than a prospective purchaser of ordinary consumer goods and who:
- purchases therapeutic goods for personal use or use by family members
- has sufficient capacity to discern where a health claim is being made by taking into account any representation or claim about the goods, and
- bears some responsibility for taking care in relation to their interests and the interests of those in their care
All reasonable interpretations of advertising claims must be considered in assessing compliance of advertisement with the Code (noting this may include messages the advertiser had not directly intended to convey).
Advertisements for therapeutic goods may be directed to particular audiences. depending on the nature of the therapeutic goods being advertised. Some advertisements are directed (either explicitly or by implication) to specific subpopulation groups for example diabetics, carers of infants and children. Other advertisements are directed more broadly - for example to adults who may have a cold. In each case, the characteristics of the audience may differ, including any particular vulnerabilities or stresses, disabilities and health literacy levels. These factors can influence the audience's perception of advertising.
Only once the target audience for an advertisement is identified can an assessment be made as to the likely 'reasonable consumer' in that audience, how that person is likely to interpret the advertisement and how they are likely to be impacted by it.
The target audience should be taken into account for an advertisement in order to properly assess the advertisement's compliance with the Code.
- the reasonable consumer assessing an advertisement for a Type I diabetes product, is likely to have some knowledge of diabetes, perhaps gleaned from having the condition and from interactions with health professionals
- an advertisement in which a medicine to improve memory is represented as having been 'clinically trialled' would lead the reasonable person within an all-adult target audience to the view that the effectiveness of the medicine has been proven through credible clinical trials
- an advertisement for therapeutic goods that targets older people with eyesight difficulties may be unbalanced if the reduced vision capacity of the target audience is not taken into account in displaying information, such as advisory or warning statements, in the advertisement
6(4) Total presentation and context of advertisement
When considering the application of the Code to advertising, the 'takeout message' that is likely to be imparted from the total context of the advertising must be considered, not just specific claims. The words (whether written or spoken) and the emphasis given to them, images and presentation of the advertisement (including the medium) will all need to be considered in determining whether the advertisement is compliant with the Code.
Advertisements can be presented in a variety of ways, including by a statement (orally or in writing), images and pictures and shop displays. Advertisements can be presented by actors, who may make promotional claims through their words, gestures and demeanour.
For example, an advertisement that states a particular therapeutic good is (only) for the relief of pain associated with mild arthritis but uses images of a person that is debilitated with pain from arthritis is likely to leave the viewer with the 'takeout message' that the product may provide pain relief for serious forms of arthritis.
Additionally, compliance with the Code is required for pack-shot images (and the wording contained thereon) when they are included in consumer advertising.
6(5) Who the Code applies to
Subject to the jurisdictional constraints set out in Section 6 of the Act, the Code applies to any person who advertises, by any means, therapeutic goods; or causes the advertising, by any means, of therapeutic goods to the public. Examples of persons who might advertise, or cause the advertising of, therapeutic goods include the following:
- the sponsor of the goods - i.e. the person in relation to whom the goods are included in the ARTG
- any person in the supply chain for the therapeutic goods (for example manufacturers, wholesalers, retailers, franchisees, multi-level marketers) who advertises the good
- a publisher, broadcaster, datacaster, internet or mobile service provider, or any other media service provider
- an advertising agency involved in creating and disseminating advertisement for goods
- any person who receives valuable consideration for advertising or promoting the goods (including influencers, bloggers and product ambassadors)
- any person publicly endorsing the goods
- a print or broadcast organisation
- a health practitioner advertising therapeutic goods or promoting services that require the use of a specific therapeutic good
6(6) and (7) Genuine news
Genuine news must be accurate, balanced, factual, impartial and non-promotional, otherwise it would be considered to be advertising. News that promotes the use or supply of a therapeutic good is advertising and would be subject to the provisions of the Act and the Code. Media releases about therapeutic goods may either be considered to be genuine news or advertising depending upon both their content and context.
The Code does not apply to genuine news that is broadcast or published in any medium by:
- broadcasters, datacasters and the SBS (Special Broadcasting Service)
- publishers of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia
Public interest and entertainment programs (including current affairs programs) that are non-promotional and presented in an accurate, factual, balanced and impartial way are unlikely to be considered advertising. However, as these types of programs are more likely to take a particular stance on issues (see section 3.4.3 of the Commercial Television Industry Code of Practice 2018, steps should be taken to ensure they are either not advertising therapeutic goods or, if they do advertise therapeutic goods, do so in a compliant manner.
The republication of genuine news in certain contexts by parties other than those identified in section 6(7) could render the content part of an advertisement for therapeutic goods for example if the news segment was posted on an advertiser's website or social media account and was associated in any way with a therapeutic good.
All parties involved in advertising therapeutic goods to the public have responsibilities to ensure compliance with the Code.
For example, in the case of a shelf "wobbler" in a pharmacy chain or buying group, the responsibility for compliance may lie with that pharmacy chain or group. However, where the pharmacy chain or group or a pharmacist sole trader demonstrated that they had received the shelf wobbler in good faith from the sponsor of the goods and had undertaken reasonable steps to ensure the content of the wobbler was compliant (such as receiving documented assurance that the wobbler is compliant with the Code), the sponsor is likely to be considered the responsible advertiser.
CRP decision highlight - Information on retailer websites is the responsibility of the website publisher
Publishers of websites should be aware that they are responsible for the material they publish, regardless of whether they have copied that material from product packaging or other websites. In complaint 4-0707, an online retailer and advertiser argued that they had 'absolutely no way of knowing whether [the product sponsor is] in fact justified in what they say about' the advertised product, and explained that 'text on our website is originally all copied from the respective manufacturer's websites and other publicity they provide when the product is launched'. In its determination the Panel noted as follows:
12.) In the view of the Panel, it is an extraordinary proposition that a publisher of a commercial website could publish information regarding therapeutic goods that are for sale by means of that website, and disavow any responsibility for the accuracy of that information, or publish information when by their own acknowledgment they have 'absolutely no way of knowing whether [the product sponsor is] in fact justified in what they say' about the advertised therapeutic goods.
13.) Where an advertiser publishes information regarding a product in an advertisement, it is a prima facie presumption that the advertiser is the person responsible for publishing that information even where it has been copied from material published by the product sponsor. Material that has been compiled from sources such as product packaging or other material may not be current, may not have been provided with the intention that it be reproduced in advertising by others, or may in some other way be deficient. Such material may have been reproduced without the consent, control, or authorisation of the product sponsor.
14.) If, therefore, the product sponsor or some other party is to be considered responsible for the information contained in the advertisement, rather than the advertiser, it would (at a minimum) be necessary for the advertiser to provide documentary evidence that the information was provided to the advertiser expressly for the purpose of advertising the product. This is not to say that retailers must hold evidence in the same way that product sponsors must. It is simply to say that if a retailer is in the business of advertising and selling therapeutic goods, it is not unreasonable to expect that retailer to take on the responsibility, at a minimum, of instituting a process whereby the accuracy of advertising claims is explicitly warranted by the product sponsor, and this warranty is documented.
6A & 6B Repeal and Transitional arrangements
While the Therapeutic Goods Advertising Code 2015 (2015 Code) and the Therapeutic Goods Advertising Code 2018 will be repealed at the same time the Code comes into force on 1 January 2019 (see Schedule 5 to the Code), the 2015 Code will continue to apply for the duration of the transition period in relation to advertisements for therapeutic goods that were approved under Division 2 of Part 2 of the Regulations before the commencement of the Code. The transition period means the period beginning on the commencement of the Code (1 January 2019) and continues to apply until either:
- the day on which the approval number for the advertisement expires, in accordance with the Regulations; or
- for an advertisement for which approval is withdrawn in accordance with the Regulations, the day on which approval is withdrawn.
Therefore advertisements approved under the pre-approval arrangements in the Regulations that were assessed against the 2015 Code, will continue to be subject to the 2015 Code in accordance with the conditions specified above.
For all other advertisements (those not requiring pre-approval under the Regulations), they should comply with the Code from 1 January 2019. However 'enforcement discretion' in relation to new requirements for mandatory information will be utilised throughout 2019, in particular in the first half of 2019 - see Therapeutic goods advertising changes. For information on the changeover to the Code from the 2015 Code, also see Changeover to Therapeutic Goods Advertising Code 2018.
Note: The information in this section is now historical and currently under review since the requirement for advertising pre-approval ceased on 1 July 2020.
7 Price information
Prescription medicines, as listed in Schedules 4 and 8 of the Poisons Standard cannot be advertised to the public as it is an offence to do so under subsection 42DL(1) (or subsection 42DLB(7) for the corresponding civil offence) of the Act. The same prohibition applies to pharmacist only (Schedule 3) medicines that are not listed in Appendix H of the Poisons Standard. However, price lists for such medicines can be issued to the public.
To ensure that dissemination of price information does not promote the use of particular prescription medicines, it is essential that price lists comply with Schedule 4 of the Code.