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Advertising to the public

Complying with the Therapeutic Goods Advertising Code (No. 2) 2018

2 January 2019

Book pagination

Part 2 - General requirements for the advertising of therapeutic goods

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.

8 Approved advertisements

This section only applies to medicine advertisements which:

  • have received pre-approval from the Secretary's delegate under Part 2 of the Regulations
  • are published in mainstream media or in displays about goods (including posters in shopping malls, in or on public transport, and on billboards, as required by paragraphs (a) and (d) of the definition of 'specified media' in section 42B of the Act)

Information on how to obtain pre-approval for medicines advertising in specified media is available in the ARGATG.

An approved advertisement that appears in mainstream media or is a display about therapeutic goods must include its distinguishing approval number allocated in accordance with regulation 5J. The approval number must stand alone, be legible and be located in the bottom right hand corner of approved print advertisements, displays about goods such as posters in shopping malls, in or on public transport and on billboards.

9 Accuracy

This section of the Code is an overarching specification of the fundamental truthfulness requirements for therapeutic goods advertising.

The Code requires that claims must be valid and accurate as well as substantiated.

'Advertising claims' refers to all claims made in advertising material - that is, claims of therapeutic effect and all other claims. A claim can be an explicit or implicit statement describing the positive effect or attribute of a product. All elements of an advertisement must be considered in identifying claims, including text, product name, pictorial representations etc. Further, all claims must be consistent with the advertised goods' indication or intended purpose as it is recorded on the ARTG (see section 9(d) below).

A 'valid' claim is one that is authoritative, sound or well-founded, while an 'accurate' claim conforms to the truth and is free from error (refer to the Macquarie Dictionary). An accurate claim is a truthful claim and is correct.

All claims (both therapeutic or non-therapeutic) made in therapeutic goods advertising must have been substantiated prior to the advertising of the product. This means that evidence must held that can demonstrate the accuracy of every claim that is made in the advertisement. The kind and amount of information required to substantiate a claim will depend on the type of claims made (including any implied claims - see below).

Therapeutic use claims

For therapeutic use claims, (see definition of 'therapeutic use' in the Definitions section of these Guidelines) evidence requirements apply. These requirements should also be considered in the context of the requirements for claims to be truthful, balanced and not misleading (see section 9(b) below).

Therapeutic claims (as well as other types of claims detailed below) must be capable of substantiation. The advertiser must hold evidence at the time of the advertisement that adequately demonstrates the claim is accurate and valid and it must be commensurate with the level and kinds of evidence needed to substantiate the inclusion of the good in the ARTG. Such evidence, depending on the nature of the therapeutic use claim and the good(s) being advertised may comprise:

  • clinical study reports on the actual therapeutic good being advertised
  • if clinical data is not available on the actual therapeutic good, a justification and reference to ingredients (for medicines) or to similar devices (for medical devices)
  • literature reviews
  • objective critical review of all data presented by an independent clinical expert

Guidelines setting out the principles on how to demonstrate evidence of efficacy or performance are available for:

These guidelines should be taken as a minimum standard for evidence requirements to underpin therapeutic claims in an advertisement. Advertisers should take care that the supporting evidence for the therapeutic claims in an advisement must be commensurate with the level of the claim.

For example, a product is listed on the ARTG for the temporary relief of heartburn based on a single small clinical trial of adults of all age ranges assessing relief over 2 hours. An advertising claim such as 'clinically proven to relieve heartburn in the elderly for 8 hours' would require the sponsor to have based the claim on additional supporting evidence demonstrating this outcome in the specific patient population for the claimed timeframe. They would need to supply this evidence to the TGA if required.

Regardless of the level of the claim, each therapeutic use claim must be consistent with the accepted indication (medicine) or intended purpose (medical devices) of the therapeutic good(s) being promoted.

Other types of claims

Claims other than therapeutic use claims can be made about therapeutic goods and these also must be substantiated, valid, accurate, truthful, balanced and not misleading.

For example:

  • marketing statements unrelated to the therapeutic use of the goods (for example gluten free, 20% off this week, 4 out of 5 people prefer this brand, improved flavour)
  • claims related to effectiveness or performance (for example relief in just an hour, non-drowsy)

The type of evidence needed to substantiate such claims will vary depending on the claim and the strength of the claim.

In addition to being substantiated, advertising for therapeutic goods must be truthful, balanced and not misleading. This includes any implied claims.

In order to be truthful and not misleading, the strength of claims made in advertising must be consistent with the level and type of available evidence. The strength of the claim should also reflect the whole body of evidence. For example, a claim that a medicine is 'clinically proven to relieve headaches', supported only by a preliminary clinical trial of 20 patients with tension headaches, would not be considered truthful and would be seen as misleading consumers for a number of reasons:

  • a preliminary trial would be unlikely to meet TGA evidence requirements for medicine indications
  • a single trial of only 20 subjects would also be unlikely to meet TGA evidence requirements for medicine indications
  • the claim relates to 'headaches' generally, yet the trial only related to a specific kind of headache

A claim can be truthful but still mislead people. For example, an imaging device that is advertised as producing 5 times less radiation than other common imaging devices but fails to provide that information in the context that the amount of radiation produced by such devices is only very small, is likely to mislead consumers into thinking other imaging devices are harmful.

Similarly, claims in an advertisement that can be verified, but the advertisement is presented in a way that lacks balance can also mislead. The term 'balance' embraces the overall balance of statements, claims, implications or representations made within an advertisement. The inclusion of health warnings where required, can, for example assist to lend balance to an advertisement.

An advertisement that omits or minimises important information and/or emphasises certain information about a product would be unbalanced and could also mislead.

CRP decision highlight - The use of the words 'clinically proven' should be carefully considered

The Panel is concerned at the growing use of the words 'clinically proven' in advertisements for therapeutic goods, when these words are not supported by an adequate and appropriate body of evidence that relates to the specific product (and not merely to a similar product or ingredient) to which the advertisement relates. In complaint 2008-02-005, the Panel noted:

  • The Panel also noted the use of the words 'clinically proven' in relation to the product. Given the strength of this claim and the clear potential for it to mislead and deceive consumers, the Panel considers that its use in advertising should not even be contemplated unless unequivocally supported by robustly designed, published, peer-reviewed clinical trials which have been conducted upon the actual product being advertised or an identical formulation (as a minimum). Even where such evidence is available, the claim must also reflect the weight of all available evidence and not just the specific research being relied upon.

A related point has been made in determinations regarding undue emphasis on the weight of scientific evidence in relation to products. For example, in 16-0907, the Panel stated:

  • When advertisers of therapeutic goods make representations regarding the efficacy of those therapeutic goods, they must ensure that the strength of the evidence is reflected in the strength of the representations. Where evidence is very strong, strong claims may be justified. Where the evidence is of modest quality (but nonetheless supports claims of product efficacy), advertisers must take care not to overstate the quality and nature of the evidence when making claims about the product.

Comparative advertising is advertising that identifies a competing product and may make or imply certain claims about the competing product. Consumers can be particularly susceptible to comparative advertising for therapeutic goods. They are unlikely to have sufficient knowledge to comprehend the subtleties of this type of advertising and their lack of knowledge can easily be exploited. An advertisement which compares the advertised good with one or more competitor or other goods must not expressly or by implication lead the consumer to a view that the comparator goods are harmful or ineffectual.

Comparative statements can include therapeutic (for example efficacy) and non-therapeutic (for example attribute) claims. Comparative advertising should be factual and substantiated and should not discredit other products either directly or by implication. Hanging comparatives such as 'higher strength' or 'better absorbed' should not be used unless it is clear to the audience to which product(s) comparison is being made. Comparative advertising, like all advertising, must comply with all relevant Code provisions and must not mislead the consumer about the benefits of the advertised good in comparison with the other products including by taking advantage of consumers' lack of knowledge. Advertisers should ensure such advertisements are balanced and fair.

Examples:

  • The claim made of a liquid vitamin preparation 'alternative to gummies' is a comparative claim. However it is unlikely to mislead or imply that the therapeutic goods with which comparison is made are harmful or ineffectual.
  • An advertisement for a complementary medicine product contains claims such as 'natural anti-inflammatory'. The advertisement makes comparisons between the advertised good and other therapeutic goods such as cortisone. This advertisement would be likely to be in breach of this Code provision because of the implication that the comparator good is harmful.

Advertising needs to be consistent with the ARTG entry or entries for the advertised therapeutic goods, unless the goods are exempt from inclusion in the ARTG. Where the goods are exempt from inclusion in the ARTG, the advertising must be consistent with the labelling (medicines, other therapeutic goods and most devices) or packaging (some devices where they are not labelled) to avoid being misleading. Consistency must be gauged from the total context of the advertisement.

The need for consistency extends to all aspects of the full ARTG entry. This includes (but should not be interpreted to mean the reproduction of this information):

  • the name (noting that the "name of the medicine" defined by TGO 92 will always be consistent with the name entered on the ARTG) or description of the goods (for medical devices)
  • the dosage form (for example tablets, capsules, topical liquid) or, in the case of medical devices, the GMDN code
  • the formulation of the goods (noting that the advertising of excipients as having or enhancing a therapeutic use would not be consistent with the entry. This may also breach other provisions of the Act.)
  • the intended purpose (for the purposes of this provision, this includes indications, for example, for medicines) (Note that this id discussed further below in relation to adverting an intended purpose that is not included on the labelling or packaging of the good)
  • any conditions applied to the ARTG entry (including those that may constrain the way in which the goods can be promoted)
  • particular warnings or contraindications

For example, an advertisement that promoted a complementary medicine as having 'the healing powers of aloe vera' where the formulation of the medicine in the ARTG listing did not include aloe vera as an active ingredient would contravene this requirement. Further, if the medicine did not contain aloe vera at all, the advertisement would be misleading (see above).

Being consistent with the ARTG entry does not require all of the ARTG information to be replicated in the advertisement.

Particular care is needed when advertising a range of goods under an umbrella name, especially where the individual goods may not have the same indications.

The Act defines an 'indication' as a specific therapeutic use. For example, the claim 'helps relieve constipation' is an indication and a therapeutic use claim. However, qualifying the indication with a timeframe in which the therapeutic results are expected to be achieved, but which is not a therapeutic claim, is nevertheless a claim which would need to be substantiated for example 'helps relieve constipation within 24 hours'. Advertising claims that are not indications are not required to be included in the ARTG entry for the goods but they must still be consistent with the ARTG entry and must be valid, accurate, truthful, balanced and not misleading.

While therapeutic claims made in an advertisement need to be consistent with the indication or the intended purpose of the therapeutic good, they do not need to replicate it exactly. Qualifying or clarifying information attached to the therapeutic claim can be used if such information is supported by evidence.

For example, a medicine indicated for the relief of hay fever symptoms may be advertised to 'provide relief of hay fever symptoms' along with the provision of further information such as 'will not cause drowsiness'. So while the claim 'will not cause drowsiness' is not a part of the medicine's indication, it can be used if the advertiser holds sufficient evidence to substantiate it. Conversely to imply an antihistamine was suitable for use at night when driving for example setting the advertisement in the interior of a vehicle at night while moving, would not be consistent with the entry if it included information that it may cause drowsiness.

However, if an indication in the ARTG entry has been qualified (for example to limit it to a specific population), that information must also be used whenever the indication is used in advertising.

In certain circumstances a claim may be consistent with the ARTG entry but still not compliant with the Code. Particular care should be taken if a therapeutic claim is consistent with an indication or intended purpose entered on the Register but that use is not included on the label or packaging of the good. While the claim may be consistent with entry it may be confusing at best and misleading at the worst where the consumer relies on the claim in the advertisement but cannot find a matching claim on the good.

Being consistent with the ARTG entry does not guarantee an advertisement complies with all the requirements of the Code.

10 Effect

10(a)(i) Present the goods in accordance with directions or instructions for use

Advertising must present therapeutic goods in accordance with:

  • the directions for use on the labelling approved by the TGA (for registered medicines and disinfectants)
  • the directions for use as they appear on the medicine's label (for listed medicines)
  • the instructions for use prescribed by the manufacturer (for medical devices and other therapeutic goods)

For example, an advertisement that shows a medicine being administered to children for the relief of pain when there are no approved dosage instructions for children on the label of the medicine is likely to contravene this provision. Such a representation could also lead to the inappropriate use of the advertised medicine and would be misleading (see above).

10(a)(ii) Not exaggerate product efficacy or performance

Exaggerating product efficacy or performance in advertising will generate unrealistic consumer expectations, and could mislead and be inaccurate.

Exaggeration of product efficacy or performance can occur in various ways and may include:

  • omitting important information - for example that the product's efficacy has only been established in a particular population group
  • through the use of explicit or implied claims that the advertised good offers therapeutic effects which exceed the indication/intended purpose of the good
  • through the use of overstated terminology such as 'powerful', 'strong', 'certain' or 'proven', which may be acceptable in relation to specific claims where there is evidence
  • through the use of testimonials which refer to unrealistic or unusual therapeutic effects

Claims in an advertisement which state or imply that a particular health condition (either expressly named or implied by reference to a symptom or group of symptoms) can be adequately treated or managed by using the advertised therapeutic good could result in consumers placing undue trust in the good. They could also delay seeking medical attention when such attention is necessary for the proper treatment or management of the condition.

For example:

  • a claim like 'Itchy rash down there? This will fix it! Get it at your supermarket!' in advertising for a barrier cream could result in consumers attempting to self-manage a condition for which timely health professional treatment is necessary
  • an advertisement that refers to the negative side-effects of a class of prescription medicines (for example antibiotics) while promoting the advertised goods as an alternative could result in consumers failing to use prescribed treatment (as well as being non-compliant with 9(c) of the Code).

Advertisements which make therapeutic claims that exceed, or are inconsistent with the advertised good's indication or intended purpose could encourage inappropriate use (as well as exaggerate product effectiveness).

For example, advertisements for:

  • a medicine containing caffeine with claims like can 'help you study all night' would encourage inappropriate use
  • a sunscreen that represents the product as 'giving long lasting protection' could give consumers the impression that the sunscreen could be relied upon for extended periods without reapplication, thereby encouraging inappropriate use
  • a medical device which has the intended purpose of alleviating snoring that promotes the use of the device for the more serious condition of sleep apnoea would be likely to encourage inappropriate use
10(d)(i) Safe, cannot cause harm, no side effects

Therapeutic goods may have unintended consequences or trigger an adverse event.

For these reasons, this section of the Code specifically prohibits the advertising of a therapeutic good as safe or having no side-effects, even for specific patient populations or at particular dosages. This requirement applies even if it is considered that there is evidence to substantiate such a claim.

Similarly, advertising claims that imply a therapeutic good is "safe" are also prohibited. Examples of such prohibited claims include:

  • '[the therapeutic good] has a safe mode of action'
  • 'No known side effects'
  • 'Safe alternative'
  • 'Non-toxic amounts of [ingredient]'
10(d)(ii) Effective in all cases of a condition, guaranteed, sure cure

Individual responses to therapeutic goods vary. Therefore advertisements for therapeutic goods must not contain any claim, statement, implication, or representation that the use of the goods will be effective in every case of a condition. Further, while it may be permissible to offer a money back or satisfaction guarantee, the Code also prohibits claims which state or imply that a product is guaranteed to work in regards to its therapeutic action.

For example:

  • 'Lose 3 kilos in 3 days'
  • 'No more arthritis'
  • 'Say goodbye to sick days forever'
  • 'Clinically proven to get rid of your abdominal fat'
  • '100% guaranteed to eradicate head lice and nits'
10(d)(iii) Infallible, unfailing, magical or miraculous

Individual responses to therapeutic goods vary even when such individuals are afflicted with the same or similar health condition. Efficacy will depend on a number of factors which can be specific to individuals. No therapeutic good will be effective in all cases of a condition.

The use of exaggerated language such as 'revolutionary', 'amazing', 'incredible' is unlikely to be acceptable in advertisements for therapeutic goods. Apart from such terminology being in breach of 10(d)(ii) and/or (iii) of the Code it will also invariably be unable to be substantiated. Such terminology will present consumers with an unbalanced impression of the therapeutic good(s) being advertised and as such also likely to be misleading.

For example:

  • an advertisement for a multi-vitamin and mineral product which was represented in an advertisement as 'the holy grail of good health' may give the reasonable consumer the impression that the product had a miraculous or infallible quality
  • an advertisement for a magnesium supplement which contained the claim 'a revolutionary solution for your health' is likely to give the reasonable consumer the impression that the product is infallible
10(d)(iv) Harmful consequences may result from not using the goods

This section prohibits the advertiser from claiming that harmful consequences may result from the therapeutic goods not being used, unless that claim is approved under s.42DF or permitted under s.42DK of the Act (provisions relating to the use of 'restricted representations').

Advertisers must not use 'scare-mongering' to promote the use of the good. An advertisement could do this by:

  • implying that the consumer's health may suffer by not using the advertised good
  • exaggerating adverse consequences of not treating a health condition
  • implying that the use of an advertised good is essential for normal health
  • implying that a health condition will become more serious if the advertised good is not used

11 Pharmacist-only medicines (required statement)

Section 11 recognises the professional responsibility of pharmacists for providing access to pharmacist-only medicines (medicines that are included in Schedule 3 of the Poisons Standard). Only those medicines listed in Appendix H of the current Poisons Standard can be advertised to the public.

Section 11 does not apply to:

  • labels, patient information leaflets or Consumer Medicine Information (CMI)
  • an advertisement displaying only the name or picture of therapeutic goods or their price or point of sale, provided the advertisement does not contain or imply a claim relating to therapeutic use, or any other representation

This section requires the use of the statement:

ASK YOUR PHARMACIST - THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU

which must be 'prominently displayed or communicated'.

This statement is to ensure that consumers understand that they have to talk to a pharmacist who can assess the suitability of the medicine for the individual. Factors the pharmacist may need to take into account include the use of other medicines by the consumer and type and duration of their symptoms.

12 What must advertisements contain - goods that are not available for physical examination before purchase

Consumers can purchase therapeutic goods through certain channels without the opportunity to physically examine the goods and thus be able to read information available on the label and/or packaging to establish whether it is suitable for their needs. Therefore, it is important that advertising that promotes supply through these channels contains a greater level of information than other advertising.

Examples of channels through which a consumer could purchase a therapeutic good without being able to physically examine it first include:

  • internet marketing
  • direct marketing (for example, a mail-order catalogue or telemarketing)
  • digital and other direct marketing sources where the consumer is able to directly purchase within an advertisement.

Section 12 sets out the minimum requirements for advertising for therapeutic goods that are not available for physical examination before purchase. It refers to Schedule 1 - Medicine ingredients with specific health warnings.

This Schedule sets out when a health warning, or alternately, the statement "This medicine may not be right for you. Read the warnings before purchase" must be used. However not all warnings required on the label are also required in advertising - Schedule 1 sets out the minimum requirements only. When considering the advertising of goods that are not available for examination before purchase, consideration may also be given to whether any other (non-mandatory) information or warnings would be of benefit to the consumer in making their decision to purchase.

Please note however that all parts (that is parts 1 - 4) of Schedule 1 apply to section 12. In effect this means, for example, that certain allergen warnings that are not required in advertisements set out in section 13 are required in advertisements where the physical product is not available for examination before purchase. This additional requirement for advertisements covered by section 12 is to ensure that allergy sufferers do no inadvertently purchase a product that would be dangerous to their health. This requirement does not extend to advertisements through which the product cannot be directly purchased as allergy sufferers are usually well aware of what substances they are allergic to and are accustomed to searching for this information on the medicine label before they purchase the product.

Section 12(1) sets out the information which must be included in an advertisement for a medicine, where the physical product is not available for examination before purchase.

Section 12 does not apply to:

  • advertisements covered by section 11
  • labels
  • Consumer Medicine Information
  • patient information leaflets

Section 12(3) sets out that required statements which must be prominently displayed or communicated must be displayed in close proximity to one of the following:

  • the first use of the name of the goods in the advertisement
  • (except for a medicine) where the name of the good is not used—the first image of the primary pack of the medicine in the advertisement
  • (except for a medicine) where the name and image of the good is not used—at the beginning of the advertisement
Name of the medicine

Section 12(3)(a) requires an advertisement for a medicine to include a reference to the 'name of the medicine' as defined by the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92).

  • where the medicine to be advertised is entered in the ARTG, use the name of the medicine appearing on the Certificate of Registration or Certificate of Listing in relation to the medicine (with exclusions specified in TGO 92)
  • where a medicine is not entered in the ARTG, use either:
    • the registered trade mark for the medicine
    OR
    • a unique, invented, common or scientific name, assigned to the medicine by the sponsor and appearing on the label
  • where a medicine is advertised as part of a range of medicines, use the trade name for that group of medicines. However, advertisers must ensure that any individual medicine advertised as part of the range must also comply with all the requirements of Section 12
Dosage form and quantity

Sections 12(3)(b) and (c) require an advertisement for a medicine to also contain respectively:

  • the name of the dosage form of the medicine, within the meaning of TGO 92
  • the quantity of the medicine, within the meaning of TGO 92
Indications for the medicine

Section 12(3)(d) requires an advertisement for a medicine to include the indications for the medicine as they appear on the medicine's label.

There is no requirement for the reference to the indications made in the advertisement to be presented word-for-word as they appear on the medicine's label. However, the meaning and intent must not differ. See examples given for section.

Medicine ingredients

Section 12(3)(e) requires an advertisement for a medicine to contain a list of the active ingredients and any other ingredient required to appear on the label of the medicine.

Health warnings

Some therapeutic goods, particularly certain medicines may have significant contraindications. An example is medicines that should not be used by individuals with particular conditions, for example pregnant or lactating women.

Where these contraindications are sufficiently serious that particular individuals should not use the product they are required to be included on the label or in the instructions for use for the good. In this situation, they are collectively referred to in the Code as 'health warnings'. The definition of 'health warning' is set out in section 4 of the Code.

It is essential to bring health warnings to the consumer's attention before they purchase the goods as these warnings are critical to their decision to purchase. Consistent with this aim, statements alerting the consumer to the existence of health warnings are required to be prominently displayed or communicated in any advertising.

Prominently displayed or communicated

The requirement for 'prominently displayed or communicated' is consistent with the requirement for 'displayed or communicated' from the 2015 Code, that is, 'standing out so as to be easily read from a normal viewing distance, and/or heard and understood'.

Essentially, 'prominently displayed or communicated' information is information that is conspicuously or noticeably displayed. It must be clear and stand out so that it is easily noticed by a consumer. Factors which need to be taken into consideration include font size, clarity and contrast, and duration (pace). The Australian Competition and Consumer Commission (ACCC) provides the following advice[2].

What is 'prominent' may vary on a case-by-case basis and you should consider factors such as the advertising medium, size, placement, colour and font of the price, as well as the background of the advertisement.

Free TV has also provided advice about prominently displaying information specific to television advertisements[3].

The onus is on the advertiser to ensure mandatory information can be read or heard clearly such that it can be readily noticed by the audience to whom it is directed.

Care must be taken in internet and other digital advertising that the required information is readily available to the consumer without the need to click tabs to locate the information. Further information is available under Prominently displayed or communicated examples.

Required statements for medicines

Section 12(3)(f) sets out the required statements in an advertisement for a medicine based on whether there are health warnings (as defined in Section 4 of the Code) for the medicine or not.

  • if there are no health warnings for the medicine:
    • the statement ALWAYS READ THE LABEL must be prominently displayed or communicated
  • if there are health warnings for the medicine, either
    • the statement THIS MEDICINE MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE must be prominently displayed or communicated and followed immediately by information about where the health warnings can be found. The health warnings must be provided within the advertisement. The information about the location could be explicit directions, a link or any other means appropriate to the medium in which the advertisement appears
    OR
    • both the statement ALWAYS READ THE LABEL together with the health warnings must be prominently displayed or communicated

Section 12(3)(g) also requires the additional statements in the provisions listed below to be prominently displayed or communicated:

  • section 13(6), regarding following the directions or instructions for use

Section 12(3)(h) requires the additional statements mentioned in:

  • section 13(7), regarding changes to symptoms

Section 12(4) sets out the information which must be included in an advertisement for a medical device where the physical product is not available for examination before purchase.

Sections 12(4)(a), (b), (c) and (d) require an advertisement for a medical device to contain the following information respectively:

  • an accurate description of the device
  • if a trade name is available, a reference to it; or otherwise, a reference to another name for the device
  • the intended purpose of, or indications for, the device
  • a list of ingredients for the device, where relevant.

Advertisers should note that some medical devices include medicines while others may have substances on or in the device that may be required to be shown on the label. The "dictionary" definition of active ingredient is applicable for devices. That is any biologically active ingredient included in or with a device that is essential for the intended purpose of the device. In particular, "relevant" ingredients are these active ingredients and any other ingredients referred to in a warning required to be displayed on the label or packaging of the device under Essential Principle 13. Advertisers may note this requirement does not extend to additional ingredients that are required to be displayed on the label or packaging by the Poisons Standard.

Intended purpose

Further information about the intended purpose for medical devices is available in section 11.

Required statements

Section 12(4)(e) sets out the required statements for an advertisement for a medical device based on whether there are health warnings for the medical device or not. The required statement will depend on the packaging of the device.

  • if there are no health warnings for the medical device:
    • either of the statements ALWAYS READ THE LABEL or ALWAYS READ THE INSTRUCTIONS FOR USE, as appropriate to the primary pack for the device, and the statement must be prominently displayed or communicated
  • if there are health warnings for the medical device, either
    • the statement THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE must be prominently displayed or communicated and followed immediately by information about where the health warnings can be found. The information about the location could be explicit directions, a link or any other means appropriate to the medium in which the advertisement appears.
    OR
    • alternatively either the statement ALWAYS READ THE LABEL or ALWAYS READ THE INSTRUCTIONS FOR USE, as appropriate to primary pack for the device, accompanied by the health warnings with both the statement and health warnings prominently displayed or communicated

The following additional statements are also required in the advertisement:

  • section 12(4)(f) requires the additional statements required by section 13(3) regarding changes to symptoms to be prominently displayed or communicated (as applicable)
  • section 12(4)(g) requires the additional statements required by section 13(2) regarding following the directions or instructions for use to be prominently displayed or communicated

Section 12(5) sets out the information which must be included in an advertisement for other therapeutic goods where the physical product is not available for examination before purchase.

Sections 12(5)(a), (b), (c) and (d) requires an advertisement for an "Other Therapeutic Good" to contain the following information respectively:

  • an accurate description of the goods
  • if a trade name is available a reference to it; or otherwise, a reference to another name for the goods
  • the intended purpose of, or indications for, the goods
  • a list of ingredients for the goods, where relevant
Required statements

Section 12(5)(e) sets out the required statements in an advertisement for Other Therapeutic Goods based on whether there are health warnings for the good or not. The required statement will depend on the packaging of the good.

If there are no health warnings for the other therapeutic goods:

If there are health warnings for the good, either

  • the statement THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE must be prominently displayed or communicated and followed immediately by information about where the health warnings can be found. The information about the location could be explicit directions, a link or any other means appropriate to the medium in which the advertisement appears.

OR

  • Both the statement ALWAYS READ THE LABEL or ALWAYS READ THE INSTRUCTIONS FOR USE (as appropriate to primary pack for the good) accompanied by the health warnings with both the statement and health warnings to be prominently displayed or communicated

The following additional statements are also required in the advertisement:

13 What advertisements must contain - general rules

Section 13 sets out the information which advertisements for medicines, medical devices and other therapeutic goods must contain where the goods will be physically available to be examined by the consumer before purchase.

This information includes describing the goods, their use and alerting consumers through advertising to any health warnings for the product.

Section 13 does not apply to:

  • advertisements which provide for the purchase of the advertised good directly (such that the consumer is unable to physically examine the good before purchase) as these types of advertisements have requirements for the inclusion of additional information section 12) when compared with section 13
  • labels, patient information leaflets or CMIs
  • advertisements for pharmacist-only medicines (section 11)
  • an advertisement displaying only the name or picture of therapeutic goods or their price or point of sale, provided the advertisement does not contain or imply a claim relating to therapeutic use, or any other representation

A sponsor's name, umbrella brand, trade name, or tag line could be a therapeutic claim in itself - in particular, where it includes:

  • the name of a disease, ailment, condition or defect
  • a sign or a symptom of a disease, ailment, condition or defect, and/or
  • a verb

It is likely to be a therapeutic claim or indication for the therapeutic good. For example, the Cold Relief People, Cold Relievers Pty Ltd, Company X Cold & Flu Relief, Rapid Itch Help.

Name of the medicine

Section 13(2)(a) requires an advertisement for a medicine to include a reference to the 'name of the medicine' as defined by the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92):

  • where the medicine to be advertised is entered in the ARTG, use the name of the medicine as specified in TGO 92)
  • where a medicine is not entered in the ARTG, use either:
    • the registered trade mark for the medicine; or
    • a unique, invented, common or scientific name, assigned to the medicine by the sponsor and appearing on the label
  • where a medicine is advertised as part of a range of medicines, use the trade name for that group of medicines
Indications for the medicine

Section 13(2)(b) requires an advertisement for medicines to include a reference to the indication(s) for each medicine included in the advertisement as the indication(s) appear on the label of the good.

For medicines entered in the ARTG, promoting an indication that has not been accepted in relation to the ARTG entry for that medicine in an advertisement is an offence under subsections 22(2), (3) and (5) of the Act. Subsection 21B(4) provides a corresponding civil penalty.

There is no requirement for the reference to the indications made in the advertisement to be presented word-for-word as they appear on the label. However, the meaning and intent must not differ. For example

  • in a case where a medicine is entered in the ARTG with the indication 'For the relief of colds'. Advertising the medicine for the relief of ear aches associated with a cold would not align with the meaning or intent of the indication in the ARTG for the medicine.
  • Similarly a claim for the product as 'Prevention of colds' would not be acceptable.

Where a medicine's label contains multiple indications, it is not necessary to refer to all of these indications in the advertisement. However advertisers should exercise care if advertising a specific subset of an indication if it could be taken to mean that the product has specificity in its actions which is not supported by evidence.

Required statements for medicines

Section 13(2)(c) sets out the required statements in an advertisement for a medicine based on whether there are health warnings (as defined in Section 4 of the Code) for the medicine or not.

Sections 11(3)(a), (b) and (c) require an advertisement for a medical device to contain the following information respectively:

  • an accurate description of the device
  • if a trade name is available a reference to it; or otherwise, a reference to another name for the device
  • a reference to the intended purpose of, or indications for the device
Intended purpose

For medical devices included in the ARTG, promoting a purpose that is not accepted in relation to the ARTG entry for that device is an offence under section 41ML of the Act. Section 41MLB provides a corresponding civil penalty.

The intended purpose for a device or class of devices can be much broader than an indication for a medicine. Establishing the intended purpose for a device varies depending on the type of device:

  • for devices that are exempt from being entered in the ARTG, the indications should be consistent with the label, the instructions for use, any advertising by the manufacturer and the manufacturer's website
  • for devices entered in the ARTG, the purpose should be consistent with the intended purpose entered in the ARTG entry for the device or class of devices as well as the label, the instructions for use, any advertising by the manufacturer and the manufacturer's website

There is no requirement for the reference to the intended purpose made in the advertisement to be presented word-for-word as recorded in the ARTG. However, the meaning and intent must be consistent with that purpose. Where a device is entered in the ARTG for more than one purpose, it is not necessary to refer to all of those purposes in the advertisement. However advertisers should exercise care if advertising a specific subset of a broader intended purpose if it could be taken to mean that the product has specificity in its intended purpose which is not supported by evidence.

Key concepts - 'Intended purpose' for medical devices

Section 13(3)(c) of the Code requires an advertisement for a medical device to include a reference to the intended purpose for that device.

Under section 41BD of the Act, the intended purpose needs to be ascertained from the information supplied by the manufacturer of the device, on or in any one or more of the following:

  1. the labelling on the main equipment
  2. the instructions for using the main equipment
  3. any advertising material relating to the main equipment
  4. technical documentation describing the mechanism of action of the main equipment
Required statements for medical devices

Section 13(3)(d) sets out the required statements for an advertisement for a medical device based on whether there are health warnings for the medical device or not. The required statement will depend on the packaging of the device and whether the label of the device, or its instructions for use, are visible on the pack in which the device is to be supplied to consumers (primary pack).

  • if there are no health warnings for the medical device:
    • either of the statements ALWAYS READ THE LABEL or ALWAYS READ THE INSTRUCTIONS FOR USE, as appropriate to the primary pack for the device, must be prominently displayed or communicated
  • if there are health warnings for the medical device, one of the following sets of statements:
    • the statement THIS PRODUCT MAY NOT BE RIGHT FOR YOU with either READ THE LABEL BEFORE PURCHASE or READ THE INSTRUCTIONS FOR USE BEFORE PURCHASE (as appropriate to primary pack for the device), with both statements being prominently displayed or communicated
    • OR

    • either READ THE LABEL BEFORE PURCHASE or READ THE INSTRUCTIONS FOR USE BEFORE PURCHASE (as appropriate to primary pack for the device), accompanied by the health warnings with both the statement and the health warnings prominently displayed or communicated

Sections 13(4)(a), (b) and (c) require an advertisement for Other Therapeutic Goods (defined in section 4 of the Code as therapeutic goods which are not medicines, biologicals or medical devices), to contain the following information:

  • an accurate description of the goods
  • if a trade name is available a reference to it, otherwise a reference to another name for the goods
  • a reference to the intended purpose of, or indications for the goods
Indications/intended purpose

For information on the indications/intended purpose for other therapeutic goods, see the information on indications for medicines.

Like medicines, for other therapeutic goods that are entered in the ARTG, promoting an indication that has not been accepted in relation to the ARTG entry for that good in an advertisement is an offence.

Required statements

Section 13(4)(d) sets out the required statements in an advertisement for other therapeutic goods based on whether there are health warnings for the goods or not. The required statement will depend on the packaging of the good and whether the label of the good or its instructions for use are visible on the pack in which the good is to be supplied to consumers (primary pack).

  • if there are no health warnings for the other therapeutic good:
  • if there are health warnings for the good, one of the following:
    • the statement THIS PRODUCT MAY NOT BE RIGHT FOR YOU with either of the statements READ THE LABEL BEFORE PURCHASE or READ THE INSTRUCTIONS FOR USE BEFORE PURCHASE (as appropriate to primary pack for the device) with both statements being prominently displayed or communicated
    • OR

    • either of the statements READ THE LABEL BEFORE PURCHASE or READ THE INSTRUCTIONS FOR USE BEFORE PURCHASE (as appropriate to primary pack for the good) accompanied by the health warnings themselves with both the statement and the health warnings prominently displayed or communicated

Subsection 13(5) exempts the application of the required statements and/or health warnings (as set out in sections 13(2)(c), 13(3)(d) and 13(4(d)) from applying to both:

  • radio advertisements that are 15 seconds or less in duration
  • written advertisements that are 300 characters or less for which there no reasonable capacity to include pictures, logos or other imagery as part of the advertisement

This means that these requirements do not apply to short formats like a 15 second radio commercial, a tweet and classified advertisements. It is not intended to provide a general exemption for all social media such as Facebook and Instagram, as these are capable of containing a greater number of words.

Short form written advertisements must only contain text and must not contain audio, video or still pictures including pack-shots. If a short form written advertisement includes pictures, videos or any other types of representations it is expected that the requirement to include the mandatory statements could be fulfilled.

This exemption would apply to text based 'Google advertisements' which have been paid for by the advertiser as long as the written advertisement consisted of 300 characters or less.

This exemption is not intended to apply to television advertisements which may contain written text, pictures, logos, or other imagery, and so are capable of including the required statements and health warnings even in a short duration advertisement. However, the required statements in a short form TV advertisement can either be provided in text or in a voiceover. However, the manner in which short duration television advertisements must comply with the obligations in the Code to include mandatory statements is not prescribed and compliance may be achieved, for example, through the inclusion of either text or spoken word statements (or both).

Any web link (if used) must lead to content that meets all the mandatories required by the Code. Similarly, the radio commercial, in its entirety must be 15 seconds or less in duration to qualify for the exemption and any reference to a website in a radio or television advertisement must meet the same requirements.

Section 13(6) requires that advertisements must contain (as appropriate to the goods), one of the following statements prominently displayed or communicated:

  • FOLLOW THE DIRECTIONS FOR USE
  • FOLLOW THE INSTRUCTIONS FOR USE

Broadly, 'directions' are used for medicines and 'instructions' for devices and other therapeutic goods.

An advertisement for therapeutic goods that contains a claim relating to one or more symptoms of a disease, ailment, condition or defect is required to prominently display or communicate one of the following statements as appropriate to the duration or recurrence of the symptoms:

  • IF SYMPTOMS PERSIST, TALK TO YOUR HEALTHCARE PROFESSIONAL
  • IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTHCARE PROFESSIONAL

The appropriate statement to use will depend on:

  • the disease(s), ailment(s), condition(s) or defect(s) concerned
  • any possible differential diagnosis from the symptoms
  • the expected natural progression of the condition
  • the expected duration of recurrence of the symptoms and
  • any other relevant factors

For example:

  • for a medicine for the relief of symptoms associated with medically diagnosed benign prostatic hypertrophy, some symptoms may be reasonably expected to persist. However, an unexpected change and/or deterioration in symptoms are likely to indicate disease progression that requires re-evaluation by a healthcare professional. Thus, the second statement "IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTHCARE PROFESSIONAL" is appropriate
  • for a medicine for the relief of symptoms associated with medically diagnosed irritable bowel syndrome, some symptoms may be reasonably expected to persist. However, an unexpected change and/or deterioration in symptoms could indicate the development of a different, possibly more serious condition and therefore needs re-evaluation by a healthcare professional. Again, the second statement is appropriate
  • for a medical device used to assist in the healing of minor muscle injuries, symptoms would be ordinarily expected to improve with time and the use of the device. Therefore, if symptoms persist, healing may be impaired and require medical assessment. In this case the first statement "IF SYMPTOMS PERSIST, TALK TO YOUR HEALTHCARE PROFESSIONAL" may be more appropriate

For listed medicines, the ARTG entry for the medicine will generally indicate which statement is the most appropriate, based on the permitted indications selected for the medicine.

The use of a symptoms statement is not required for prevention, health maintenance or wellbeing claims.

Section 13(7A) clarifies that where the advertisement must contain both the statements in subsection (7), the statements may be shortened and combined into one statement, so as to avoid duplication.

Section 13(8) provides an exemption from the requirement to include any of the statement(s prescribed by sections 13(6) and (7) for radio commercials that are 15 seconds or less in duration, or for written advertisements that are 300 characters or less for which there is no reasonable capacity to include pictures, logos or other imagery as part of the advertisement. See advice on short-form advertisements above.

14 Section 14 is intentionally not used

Section 14 of this instrument is intentionally not used. This is because the Regulations will, from 1 January 2019, contain a number of references to specific provisions of the Code which, if section 14 were to be used and subsequent sections renumbered, would require consequential amendment.

15 Scientific representations

Section 15 does not apply to:

  • labels
  • Consumer Medicine Information
  • patient information leaflets

A scientific or clinical representation, in the context of advertising therapeutic goods to the public, is one that:

  • is referenced to a supporting study, and/or
  • contains scientific terminology or clinical terminology (covering concepts such as diseases, treatments and medicines) that does not appear in the everyday language of the audience to whom the advertisement is directed

Broadly, scientific studies constitute research through the systematic collection, interpretation and evaluation of data. The type of scientific research most relevant to therapeutic goods is 'clinical studies', in particular studies on the use of therapeutic goods in the treatment or alleviation of diseases and/or symptoms.

Referencing scientific studies (including clinical studies) to support representations made in advertisements gives credibility to the representations. This credibility could be misplaced for a number of reasons including:

  • the study has not been peer reviewed
  • the study does not have sufficient subject numbers
  • inadequate inclusion and exclusion criteria for subjects have been applied
  • the study has inadequate 'blinding' (masking)
  • the study results are inconsistent with the broader body of evidence reflected in systematic reviews and meta-analyses

Where claims are validated by a reference to scientific (including clinical) studies the consumer should have available to them enough information in the advertisement to locate the referenced study.

The majority of scientific studies require funding. Where it is reasonable possible to identify the researcher and the financial sponsor of the research, their identity (where the advertiser knows or ought to reasonably to have known that information) should be clearly disclosed in the advertisement. This is particularly important when the source of funding is, or is associated with, the therapeutic good's sponsor or advertiser.

When the sponsor of a scientific study that the advertiser is using to support the veracity of a therapeutic claim is a government department or agency, the advertiser must ensure that endorsement of the therapeutic good by that government agency is not implied. However, merely stating the name of the source of funding (such as the Australian National Health and Medical Research Council (NHMRC)) for the study is unlikely to imply government endorsement of the good.

For example:

[Therapeutic ingredient] has been the subject of a scientific study* funded by the National Health and Medical Research Council (NHMRC).

*Author, Name of study and publication details

16 Endorsements

Endorsements can be made by a person or a corporation expressing their support for a product. An endorsement can be made explicitly or indirectly.

Endorsements and testimonials

The dictionary definitions for 'endorsement' and 'testimonial' overlap considerably. A 'testimonial' is a type of 'endorsement'.

  • An endorsement is made where a person, or corporation, sanctions (approves of) a particular therapeutic good but there is no indication as to the outcome(s) from the use of the good by any individual. For example, 'Company X recommends Brand Y disinfectant'
    • The endorsement can be based on evidence which demonstrates the value of the endorsed good in relation to the health condition with which the endorsing organisation is concerned (in which case the evidence must be available for provision to the TGA if required)
    • OR

    • The endorsement can be based on the endorser receiving funding or other 'valuable consideration' from a sponsor or retailer of the endorsed therapeutic good. For example, 'Organisation X receives 10 cents from the sale of every bottle of Brand Y disinfectant'. This arrangement is sometimes referred to as a 'sponsorship', however for the purposes of the Code it is taken to be a form of endorsement
    • A testimonial is made where an individual person, has used a therapeutic good and has testified as to the outcome(s) they experienced from the use of the good. For example, 'I use Brand Z cream on my eczema as it helps soothe the itch and inflammation' or 'Brand A liquid helped ease my daughter's discomfort during teething'

Both testimonials and endorsements can influence consumer choices and therefore there are certain requirements that must be met when they are used in the advertising of therapeutic goods.

Section 16(2) prohibits any endorsement of therapeutic goods in advertisements by:

  • a government authority, hospital or healthcare facility (does not include a community pharmacy)
  • an employee or contractor of one of these bodies
  • a health practitioner, health professional, medical researcher or a group of any of these persons

Such endorsements are prohibited so as to avoid a consumer being unduly influenced to purchase a therapeutic good by the weight they may give to statements made by these organisations and individuals.

Section 16(3) allows an endorsement by the following organisations and individuals where the advertisement names the organisation, discloses the nature of the endorsement, and also discloses whether the organisation, employee or contractor has received or will receive valuable consideration for the endorsement:

  • an organisation representing the interests of healthcare consumers
  • an organisation representing the interests of health practitioners, health professionals, or medical researchers
  • an organisation which conducts or funds research into any disease condition, ailment or defect
  • an employee or contractor of any of these bodies (unless they are of an individual prohibited from making an endorsement under section 16(2))

Note that organisation is defined in the Code for the purposes for section 16 only to mean any group, association or body (whether incorporated or unincorporated). This requirement ensures that consumers are aware of the details of the endorsement and if the endorsing organisation has been remunerated or in way has been compensated for their endorsement.

While testimonials can be viewed as a type of endorsement, this section does not apply to testimonials covered under section 17.

CRP decision highlight - 'TGA Approved' claims and Government endorsement

In complaint 2008-02-018, the Panel noted as follows:

  • Section 4(6)(b) of the Code prohibits representations that goods are endorsed by government bodies. While in one sense the words 'Listed with the Therapeutic Goods Administration as a herbal medicine' may constitute an attempt to indicate compliance with the Act, they are likely to convey an implication that the goods so listed are approved by an Australian government agency to a degree that is not factually correct, particularly as regards the efficacy of the product. The complaint was therefore justified. However, for the advertiser's benefit, the Panel noted that s.42DL(1)(e)(i) of the Act[4] , whilst prohibiting 'a reference to the Act', does permit a statement to the effect that 'Product X is listed in the ARTG, AUST L 123'. The Panel also noted that such a statement makes no reference to any government agency.

Care is needed with endorsements as they have the potential to promote a therapeutic good for purposes that may not be accepted in relation to particular therapeutic goods. For example, advertising a cough and cold medicine as being endorsed by a migraine patient group may imply to viewers that the medicine can also prevent or relieve migraines.

Valuable consideration, while most often a monetary exchange, can be non-monetary. For example, it may be an exchange of services in-kind, provision of product, or a promise to engage services in the future or any other return in kind.

References to business names (for example the name of a chain of a pharmacy) are commonly used in the naming of therapeutic goods to signify availability. However, this is not necessarily considered health professional endorsement of the goods.

For example a catalogue from a pharmacy that bears the name of the pharmacist owner would not be a professional health endorsement if it contains an article written by the pharmacist, with their picture and signature, about hayfever season that highlights selected products for hayfever relief would be considered an endorsement by a health professional.

However, a catalogue from a pharmacy that bears the name of the pharmacist owner would be a professional health endorsement if it contains pages of therapeutic goods images, with visible claims and prices, for hayfever relief. While these pages would be considered advertising, they convey availability of the goods through the pharmacy rather than the pharmacist's endorsement.

17 Testimonials

Testimonials must comply with all applicable aspects of the Code, not just the requirements set out in section 17. Testimonials are advertisements themselves or may form part of a broader advertisement for the therapeutic goods referenced.

Section 17 only applies to testimonials from individuals who claim to have actually used that good. Testimonials are not captured under section 16 (endorsements). Corporations may not make testimonials as it would be very difficult or impossible to verify that every employee or individual associated with a particular corporation has used the particular therapeutic good and is prepared individually to provide a testimonial along the required lines.

Only testimonials from people whose details have been verified prior to the use of the advertisement and who have used the product or who have administered the goods and observed the results (e.g. in a child) can be used in advertising for therapeutic goods. Details may include name, age, employer and address. However, a testimonial cannot be made by a person who is:

  • involved with the production, sale, supply or marketing of the goods
  • an employee or officer of a corporation that is involved with the production, sale, supply or marketing of the goods
  • a corporation
  • an employee or contractor of a government agency, hospital or healthcare facility, a health practitioner, health professional, or medical researcher

Disclosures about the testimonial are required in the following circumstances:

  • where the person providing the testimonial has received, or will receive any valuable consideration for providing the testimonial
  • where another person takes the place of the person who provided the testimonial
  • where the person providing the testimonial is an immediate family member of an individual involved in the production, sale, supply or marketing of the goods

These disclosures are required as the consumer is entitled to know:

  • if a testimonial may have been influenced by the fact that the testimonial provider has received, or will receive, valuable consideration
  • if a testimonial may have been influenced by the fact that the testimonial provider is an immediate family member of an individual who is involved with the production, sale, supply or marketing of the goods

In both these circumstances, the weight the consumer gives testimonial may be impacted.

As it may be important for the consumer to know the nature of the 'valuable consideration' provided in order to be able to assess whether, and to what extent, the testimony might have been influenced, it is recommended to disclose the nature of the 'valuable consideration'.

The disclosure, in order for it to have the effect of providing the consumer with the required information, must be noticeable and placed beneath or very close to the testimonial.

Testimonials must be consistent with the goods' accepted indication or intended purpose. For example a testimonial for a hay fever medicine must not indicate the medicine proved helpful for headache relief.

A reasonable standard for verification of a testimonial is a statutory declaration. A statutory declaration in relation to a testimonial should be made before the advertisement featuring the testimonial is published or broadcast.

Care should be taken if truncating, altering or paraphrasing a testimonial in an advertisement to ensure that it is not misleading.

The use of testimonials must also not contravene the other provisions of the Code. For example, a testimonial must not present the advertised good as 'miraculous' (paragraph 10(d)(iii)), even if there is robust scientific evidence to support excellent results from the use of the good. Caution is also needed to ensure that the use of testimonials does not result in promoting the advertised goods for a different indication or intended use than that accepted in relation to the inclusion of the goods in the ARTG as this would contravene the Act.

Advertisers are responsible for ensuring the compliance of any testimonials that are publically posted by third parties to Facebook, Twitter, Instagram or any other social media accounts and blogs where the advertiser has control of the content. Advertisers should monitor testimonials and remove non-compliant testimonials.

However, whether an unsolicited post or comment on the website, social media site, internet blog or other medium of an advertiser is a testimonial subject to the requirements of section 17 turns on whether it is 'used' in that advertisement. Section 17 is intended to ensure that consumers are aware of important facts about the testimonials as presented in the advertising, which will assist them to weigh the importance of the testimonial.

18 Incentives to pharmacy assistants and other non-healthcare professional sales persons

Pharmacy assistants and retail salespeople (for example health food shop staff) who are not health professionals covered by section 42AA of the Act are considered members of the public in terms of the application of Part 5-1 of the Act and the advertising requirements prescribed in the Code. Therefore, advertising for therapeutic goods directed to pharmacy assistants and other retail salespeople needs to comply with the Act and Code.

As the advice that retail staff give can influence consumer choices of therapeutic goods and they generally do not have the educational qualifications or experience of trained health professionals, such as a pharmacist, the Code also prohibits advertising to retail staff from containing incentives to these staff to recommend or supply the advertised goods.

19 Advertising to children

In the main, advertisements for therapeutic goods must not be primarily directed to children.

Many children are unlikely to have developed sufficient knowledge or reason to make responsible choices in relation to therapeutic goods or to understand the generally persuasive intent of advertising. Choices about when and how therapeutic goods may be appropriate for them are typically made by the adult who looks after the interests of the child. It would therefore not be responsible to target children in advertisements for therapeutic goods. There are exceptions in relation to particular therapeutic goods for children 12 years and over, consistent with their increasing independence from adults.

These requirements do not apply to labels, on which characters, colouring, fonts and other artefacts may be used to identify therapeutic goods which are suitable for use in children, including to differentiate children's dosage forms from adult preparations.

20 Samples

Even where an offer of a sample in advertising is not prohibited, advertisers should note that other advertising provisions may still apply to such offers.

Advertisers should be aware that the act of giving a sample could be an advertisement that would also need to comply with the Code.

The types of therapeutic goods that may be offered as a sample in an advertisement have been selected because of their important role in public or individual health.

21 Consistency with public health campaigns

Advertising must not be inconsistent with public health campaigns because to do so could undermine important current public health and safety messages.

Public health messages are based on considerable research and expert advice. The objective of this provision is to ensure that that advertising of therapeutic goods does not undermine or otherwise diminish the message contained in government public health campaigns.

Government priorities in public health messaging change depending on needs within the community and developments in health policy. However, a 'current' campaign does not necessarily have to be active at the time of the advertisement. For example, an advertisement for a cold and flu medicine must not undermine the most recent government respiratory health public messaging even if the advertising occurs outside of the cold and flu season.

Advertisers should remain abreast of public health campaigns that are relevant to the type of therapeutic goods they advertise, so as to identify any existing advertising that may be inconsistent with new campaigns. When preparing new advertising, advertisers need to ensure that it is not inconsistent with a relevant public health campaign of which they know, or ought reasonably to have known, will be taking place at the time of the advertisement.

Information about Australian public health campaigns is available from a range of websites, including:

Examples of relevant current public health campaigns include:

  • for sunscreens - sun safety campaigns
  • for cough and cold products - campaigns relating to the management of respiratory diseases and hygiene
  • smoking cessation
  • vaccination/immunisation

An example of advertising that would be considered inconsistent with public health campaigns include advertising a therapeutic good that is claimed to be able to prevent and reverse the lung damage caused by smoking.

This requirement is unlikely to impact the majority of advertisements for therapeutic goods.


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