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Advertising to the public
Complying with the Therapeutic Goods Advertising Code (No. 2) 2018
Other guidance on the application of the Code
Further information on 'prominently displayed or communicated'
The Code requires certain information to be 'prominently displayed or communicated' in advertisements:
- required statements for medicines and devices, described in sections 12(3), 12(4) and 12(5), which may include health warnings for specific substances
- warnings regarding persistence or worsening of symptoms and the need to consult a healthcare professional
- statements required for the advertising of Schedule 3 medicines
- statements required for the advertising of analgesics (see Section 24)
- statements required for the appropriate use of sunscreens (see Section 27)
The 'prominently displayed or communicated' requirement has been restricted to those provisions which require important mandatory information to be communicated in advertising- i.e. the messages that are critical to the consumer when self-selecting a product for self-treatment. Advertisers should be aware that the target audience of the advertisement should be considered. For example, to meet the requirement to be prominently displayed or communicated, an advertisement directed to people with eyesight difficulties may require special consideration to ensure the message is received in its entirety.
Examples of prominently displayed and communicated mandatory information
Mandatory statements are not required to be in any particular font style, size or format when included as visual statements in an advertisement, as long as they are 'prominently displayed or communicated' within the meaning of that term as defined in section 4 of the Code. For example, font embellishments (including serifs, italicised, cursive, shadowed, calligraphic, poster) and other fancy or irregular fonts, may affect the extent to which the required statement stands out so as to be easily read and understood.
The following examples are indicative of the requirements for ensuring mandatory statements are prominently displayed or communicated:
Prominently displaying or communicating information in social media
To satisfy the requirement to be 'prominently displayed or communicated' in online advertising including social media, mobile phone apps and emails:
- the information needs to be available in the same locale as the advertising content
- a pop-up may provide such information to consumers
For spoken statements, this may require:
- using a similar volume and delivery (for example pitch, speed) to the name of the therapeutic goods advertised
Ensuring that such information satisfies the requirement to be prominently displayed is dependent on the media used for the advertising. For example, for a television or internet advertisement that relies on an actor to impart the therapeutic representations including the 'main claim', it may be necessary for any mandatory statements to also be presented by the actor to ensure that they are part of the main message.
In the case of visual advertisements not designed to be viewed at once (for example, a printed brochure or a webpage that will be scrolled through) the mandatory information must be repeated as often as necessary to ensure the likelihood that it will be seen by a viewer.
Promotion of goods for use by specific populations
Where a good as being promoted for use in specific populations (for example infants and neonates), the representations are likely to be misleading unless there is specific evidence on the use of the advertised good in the referenced population to support the claims made.
Foreign language advertising
The Code applies to advertising in Australia that uses languages other than English.
Advertisers should be aware that literal translations between English and other languages (and vice versa) often distort the take out messages.
Care is also needed for mixed language advertising (where one language is usually English) as the juxtaposition of the two different languages can alter the main message.
Where the TGA receives a complaint about an advertisement that contains a language other than English, an expert accredited (NAATI) translator certified translation for the advertising will be required to be provided by the advertiser.
Definition of generic information
Generic information is defined in section 42B of the Act as including '...any statement, pictorial representation or design, however made, about the composition, properties or other characteristics of therapeutic goods, but does not include:
- an advertisement about the goods; or
- generic information included in an advertisement about the goods; or
- bona fide news'
Division 4 of Part 5-1 of the Act requires that generic information for therapeutic goods used as an ingredient or component in the manufacture of other therapeutic goods (for example, information about fish oil that is principally factual rather than promotional) must comply with any sections of the Code that are identified in the Regulations for that purpose (section 42DO of the Act refers).
The relevant sections of the Code are set out in regulation 8 of the Therapeutic Goods Regulations 1990 (currently these refer to sections of the Therapeutic Goods Advertising Code 2015), and from 1 January 2019 an updated regulation 8 will take effect that will refer to the following sections of the Code in relation to such generic information- sections 9 (Accuracy), 10 (Effect), 15 (Scientific or clinical representations), 16 (Endorsements), 18 (Incentives), 19 (Advertising to children) and 21 (Consistency with public health campaigns).
- Further information about generic information is in section 42DN of the Act.
In the transition from the 2015 Code to the Therapeutic Goods Advertising Code (No 2) 2018, the numbering of the Code sections has changed. This will be reflected in regulation 8, from 1 January 2018.
Provision of price information for medicines other than prescription medicines
The Act prohibits advertising to the general public of a substance, or a therapeutic good containing a substance, included in Schedule 3 (Pharmacist-Only medicine), 4 (Prescription-Only medicine) or 8 (Controlled Drug) of the current Poisons Standard . Substances which are listed in Schedules 3, 4 or 8 of the current Poisons Standard are, collectively referred to as, restricted scheduled substances.
Schedule 3 substances listed in Appendix H to the current Poisons Standard are permitted to be advertised directly to consumers.
A positive or promotional statement about a therapeutic good, preparation or substance that contains or is a restricted scheduled substance that is published or broadcast to the public is likely to be considered an advertisement under the Act.
Subject to certain exclusions, therapeutic goods that do not contain restricted scheduled substances can be advertised to consumers, provided that the advertising complies with the requirements under the Act, the Regulations and the Code.
If price advertising of OTC medicines is to be published in conjunction with price information for restricted scheduled substances, care is needed as there are more restrictive requirements set out in the Price Code (for example note in particular that any photographs or other reproductions of the medicine are prohibited). Combined price advertising of restricted scheduled substances and OTC/complementary medicines often fails to meet the requirements of the Price Code.
Under the Act, it is an offence to advertise to any person a therapeutic good for an indication that is not entered in the ARTATG for that medicine (that is, 'off-label' use).
Puffery is defined by the Macquarie Dictionary as the 'act of praising unduly' or 'exaggerated commendation'.
The ACCC states:
'Puffery' is a term used to describe wildly exaggerated or vague claims about a product or service that no one could possibly treat seriously. For example, a restaurant claims they have the 'best steaks on earth'. These types of statements are not considered misleading.
While puffery may be permitted in Australian Consumer Law (to the extent such claims would not be considered misleading), and there is no express prohibition on its use in the Code, there are additional requirements for advertising therapeutic goods (over and above the requirements for advertising in Australian Consumer Law) which effectively prohibit the use of puffery. For example, section 9 of the Code requires advertisements for therapeutic goods to be valid, accurate, substantiated and truthful. Section 10 of the Code prohibits the use of statements that exaggerate product efficacy or performance.
Puffery by its nature is not truthful. It is exaggerated, inaccurate and unsubstantiated and should not be used in advertisements for therapeutic goods.