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Advertising: Questions and answers on the Advertising Code

8 February 2019

During our training sessions and webinars on the Therapeutic Goods Advertising Code (No.2) 2018 (the Code), we received a large number of queries that we undertook to publish responses to.

Initially, we have released a small number of answers to some of the most common questions. We will add to these Q&As on a regular basis.

The term 'data on file' is not sufficient to meet the Code requirements for scientific and clinical citations. It is highly preferable that citations used in advertising refer to peer-reviewed published studies. However, where this this is not possible, unpublished studies can be referenced, provided the Code requirements are met.

The specific requirements for citations to scientific or clinical literature in advertising are set out in subsection 15(3) of the Code, namely:

  • any research results must identify the researcher and financial sponsor of the research, where the advertiser knows, or ought reasonably to have known, that information; and
  • the study must be sufficiently identified to enable consumers to access it.

As part of meeting the second requirement, it will be necessary for the public to be able to access the study in some way, such as by contacting your business. You will also need to sufficiently identify the study for members of the public to be able to request it. For example:

Research conducted by John Smith and Jenny Jones at Pease College, Perth with funding from Beans Inc. The research study 'The effect of peppermint oil on the human gastrointestinal tract' is available on request from Beans Inc.

However, if your business has no intention of releasing the study or data to members of the public that request it, the advertising would be misleading and therefore would breach s.9(b) of the Code. In such cases, a citation could not be used compliantly in the advertisement.

Further information: section 15 of the Code and Code guidance

A 'testimonial' is a type of 'endorsement'. The key difference is that a testimonial is made by someone that has used the therapeutic goods referred to in their statement - whether that is personally used the goods or used the goods in relation to someone they are personally caring for (e.g. a child or elder in their care). Personal use does not include carers paid to undertake caring duties.

Both testimonials and endorsements can influence consumer choices so there are special requirements that must be met when they are used in the advertising of therapeutic goods, including:

  • testimonials and endorsements used in advertising must not be from health professionals, health practitioners, medical researchers or employees of government authorities, hospitals or healthcare facilities
  • any financial incentive or other valuable consideration (e.g. the provision of products or services) relating to the provision of the testimonial or endorsement must be disclosed in the advertising

Further information: sections 16 and 17 of the Code and Code guidance

We know that advertisers are working hard to ensure that their advertising is ready for 2019 and compliant with the Code but there can sometimes be delays in getting new advertising approved, produced and disseminated for use.

Provided that your advertising is fully compliant with the 2015 Code and there are no concerns that the advertising will jeopardise public health and safety, the TGA may exercise enforcement discretion in handling any complaint about your advertising.

Further information: Compliance and enforcement discretion

The information provided in this answer only applies to catalogues where a consumer will have an opportunity to physically inspect a product that appears in the catalogue before purchasing it. If your catalogue facilitates purchase without physical inspection (e.g. the catalogue has an attached order form and so the section 13 requirements will apply) this answer does not apply to you.

There are two broad approaches to handling space limitations in a catalogue while also producing a catalogue that is compliant with the Code.

Approach 1: Use visual tools to group products with the same mandatory statements

If your catalogue includes the therapeutic claims about products, the relevant mandatory statements for those products must be included and they must be prominently displayed. One option is to group products that require the same mandatory statements together clearly displaying the statements applicable to those products. Advertisers may do this using visual tools including one or more of the following:

  • placing a border or background around the products and applicable mandatory statements;
  • displaying the mandatory statements underneath or above the product grouping, using a spatial arrangement that shows a clear relationship between the mandatory statements and the grouping;
  • any other visual tool that will ensure the relationship between the product/s and the applicable mandatory statements

These visual tools are illustrated in the example catalogue below:

Approach 1: Use visual tools

PDF version of this catalogue

How to access a pdf document

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.

Approach 2: Do not include therapeutic claims in the catalogue

If your catalogue does not include the therapeutic claims about the products, it is exempt from displaying most mandatory statements. However, the mandatory statements for oral analgesic products and sunscreens required under Part 3 of the Code must still be included and prominently displayed.

To be exempted from displaying mandatory statements in a catalogue, your catalogue must not display any 'therapeutic claims' or 'other claims'. You will need to blur or erase any claims on packshots/product images. 'Other claims' include any representation that would induce a consumer to seek out the medicine because of its advertised merits (except for price information) - for example, 'NEW!', 'Colour-free', 'Convenient dosage form for kids', 'Starts to work in 10 minutes'.

Further information: sections 11, 13, 23, 24 and 27 of the Code and Code guidance

When assessing an advertisement for compliance, the Code requires that we consider the total presentation and context of the advertisement. Information surrounding an advertisement (even if it is a few pages away) can influence the consumer's view of the advertised good and cause an otherwise compliant advertisement to breach the Code.

In the example below, an advertiser pays for the publication of an advertisement for a product for the relief of the symptoms of medically diagnosed irritable bowel syndrome (IBS) in a magazine. The advertisement is published alongside an editorial about IBS that downplays the need for a timely medical diagnosis by suggesting people should try to self-manage their symptoms first. As a result, the reader is left with a message that they could try using the advertised product to see if it relieves their symptoms rather than going to see their doctor to seek a diagnosis.

How placement of an advertisement can change the message for consumers

A consumer may decide to try an advertised product and delay appropriate medical treatment, or cease existing treatment based on the message created by the proximity of an advertisement to other information. This can have serious health implications for consumers.

If a complaint is received about an advertisement but it is the material placed near it that has resulted in non-compliance, the TGA would seek to identify who was responsible for the location and placement of the advertisement and other material. We have a number of regulatory tools at our disposal to establish who was responsible for non-compliant advertising. At times, we may issue a substantiation notice in order to obtain information about who was responsible for a non-compliant advertisement.

If you suspect that the publication of your otherwise-compliant advertisement could be used in such a way, we recommend liaising with the publisher or agent to see whether the issue could be prevented.

Further information: section 6 of the Code and Code guidance

Sections 12(3)(a) and 13(2)(a) of the Code require the 'name of the medicine' to be included in advertising for a medicine. The meaning of the 'name of the medicine' for the purposes of the Code is set out in the Therapeutic Goods Order No.92 - Standard for labels of non-prescription medicines (TGO92) and summarised below. The requirements depend on whether a medicine is entered in the ARTG or exempt from entry in the ARTG.

Medicines entered in the ARTG

Generally, medicines that are to be commercially supplied in Australia need to be entered in the Australian Register of Therapeutic Goods (ARTG).

For medicines that are entered in the ARTG, the TGO92 definition for 'name of the medicine' is the name of the medicine appearing on the ARTG entry for that medicine, with the exception of certain information.

The requirements specified in the Code are the minimum requirements for advertising. Provided that these requirements are met, advertisers can include additional information if desired.

To determine the 'name of the medicine' that must be included in advertising, you will need to:

  1. Obtain one of the following for the medicine:
    1. the public ARTG summary
    2. the ARTG certificate (only available to the medicine sponsor).
  2. From the ARTG document, identify the 'name of the medicine'. For example: the public summary of an ARTG entry for a medicine shows the name as follows:
    Summary for ARTG entry shows the name of the medicine
  3. Exclude the following information from the ARTG name:
    • the ARTG number
    • the name of the active ingredient (except where the name of the active ingredient is part of the name of the medicine)
    • the strength (except where numbers or words denoting strength are included in that name to differentiate medicines, by strength)
    • the dosage form (except where this is integral to differentiate medicines from other medicines)
    • container details
    • the pack size
    • 'new formulation' or representations to the same effect
    • flavour descriptors (except where this is integral to differentiate medicines from other medicines)
    • the name of the sponsor or distributor (except where the name forms part of the name of the medicine).

By excluding the above information, the name of the medicine that would need to be included in advertising for the example product above is 'Bean's Tonic Plus'. Any other information about the medicine required under section 12(3) or 13(2) of the Code, as appropriate for the type of advertisement, will also need to be included in the advertising.

Medicines not entered in the ARTG

Certain types of medicines are exempt from the requirement to be entered in the ARTG before being supplied e.g. low risk homoeopathic remedies.

For medicines that are not required to be entered in the ARTG, the TGO92 definition for 'name of the medicine' is either:

  • the registered trade mark for the medicine
  • a unique, invented, common or scientific name assigned to the medicine by the sponsor and appearing on the label.

Other considerations

When deciding what identifying information about the medicine needs to be included in advertising, you should also consider whether it may be misleading to omit certain information. For example, for a range of medicines that has the same active ingredient but the range consists of different strengths, it may be misleading not to include the strength.

Further information: sections 12 and 13 of the Code and Code guidance