ASMI FAQs in relation to the Therapeutic Goods Advertising Code (TGAC)

Preface

These answers have been provided by ASMI to assist its members to comply with the TGAC.

In all instances members are reminded of section 3(2) of the TGAC which states that:

"The conformity of an advertisement with this Code should be assessed in terms of its probable impact upon the reasonable person to whom the advertisement is directed."

There are informative discussions on how a panel might assess the probable impact of an advertisement on the reasonable consumer in the following ASMI and CRP determinations:

Nurofen For Children Complaint before the ASMI Panel (2013): HERE

Swisse Complaints 2011/11/001 and 2011/11/009: HERE

 FAQ

Q. The definition of "specified media" is not always clear.  In particular, what about posters displayed in shop windows? Is it true that the difference between "specified" and other media is only the side of the glass to which the poster is affixed?

A. The TGAC explicitly excludes "displays … inside individual shops" (see the definition of "specified media" in Section 2). Effectively this means that a poster on the inside of the shop window (even facing onto the street) is located "inside" the shop and so not considered to be "specified media". The same poster located on the outside of the window would fall within the definition of specified media. So if it is on the outside of the window it requires pre-approval and is within the jurisdiction of the CRP. If it is on the inside then pre-approval is not required and it cannot be complained about to the CRP.

 

Q. If there is a breach of the TGAC in a catalogue for a pharmacy chain, who is responsible for the breach? The pharmacy chain or the product sponsor?

A. Both the publisher and the sponsor have responsibilities for ensuring compliance with the TGAC. Both may be asked to respond to the CRP if a complaint is raised. However, if a non-compliant ad was published without the sponsor's knowledge then thesponsor may be excused if they can demonstrate that lack of knowledge.

 

Q. How do I know whether to complain to the CRP or to ASMI?

A. The CRP handles complaints about material in specified media (which includes TV, radio, digital and some print). You can complain about any advertiser regardless of whether they belong to an industry association or not. More information about the CRP processes is available on the "Procedures" page of the Complaints Resolution Panel website (HERE). The ASMI Complaints Panel handles complaints about material in all media, but only if the advertiser is an ASMI member. The ASMI Code of Practice does contain a mechanism for non-members to agree to be bound by the ASMI Code. More information about the ASMI processes is available on the on the "Code Determinations" page of the ASMI website (HERE).

 

Q. What is the difference between bona fide news and advertising?

A. The definition of "advertisement" in the TGAC (see Section2) is very broad and sponsors need to be mindful that it includes statements which even indirectly promote the use or supply of the goods. This captures press releases prepared by sponsors, and may even capture articles written by journalists based on those press releases.

There have been instances where the CRP has found that the proximity between a piece of "news" and an advertisement was such that the two pieces would be considered by a reasonable consumer to form a single advertisement. The two pieces do not even have to be on the same or adjacent pages to be considered together; in the past the CRP has found that a consumer could associate pieces in this way even if they were several pages apart.

 

Q. Can you please explain the exemptions in relation to advertisements which display only the "name, picture and/or price and/or point of sale"?

A. This exemption is in section 3(3) of the TGAC in relation to pre-approval and is also in section 6(2) in relation to the minimum requirements of an advertisement.  These exemptions are extremely narrow and restrict the advertiser to including these four elements and nothing else.  The inclusion of any other information (e.g. marketing claims such as "new" or "hot price") takes the advertisement outside the exemption. Note that neither the product name nor the pack shot can include a therapeutic claim. If an advertisement does not fall within the exemption, then it may require pre-approval and must meet the minimum requirements of an advertisement.

 

Q. What are the minimum requirements of an advertisement?

A. The minimum requirements of an advertisement are set out in section 6 of the TGAC and include: the trade name, a reference to the approved indications and certain mandatory statements.

 

Q. Do I have to reference my claims?

A. Section 4(4) of the TGAC provides the only mandatory referencing requirement. Other than this there is no requirement to reference a claim in an advertisement (however it may be prudent to do so). Members are reminded that section 5.1.4 of the ASMI Code imposes an obligation to provide claim substantiation without delay upon request. Section 4(4) of the TGAC is discussed in more detail below.

 

Q. What does the section on "Scientific Information" (section 4(4)) actually require me to do?

A. Section 4(4) of the TGAC introduces additional requirements in relation to the presentation of scientific information in an advertisement. This section introduces four new terms to the TGAC (none of which is defined). These terms are: "scientific information", "scientific terminology", "publication" and "research results".

We take a similar approach to interpreting these new terms in section 4(4) as we do in relation to the terms "direct marketing" and "internet marketing" in section 6 of the TGAC (see FAQ below).

Referencing?

In relation to section 4(4) it is reasonable to assume that the terms "publication" and "research results" do not mean the same things as the terms previously used in the TGAC. The drafters meant something different and they used different words to indicate this intention.

In examining section 4(4) it is useful to note that "identify[ing] the researcher and the financial sponsor of the research" is not synonymous with referencing the study. While it may be useful for practical reasons to cite the reference, compliance with section 4(4) simply requires an identification of the researcher and the financial (and not a full citation).

So what does "publication of research results" mean? On the one hand it could be something very precise (e.g. the initial publishing in a journal of a research paper) (e.g. the initial presentation of a poster at a conference). On the other hand it could be something more general (e.g. a detailed reference to the journal article). In any event "publication of research results" has to be something different to (and more than) a "claim", a "statement" or an "implication" (since these are the terms used in the preceding section of the TGAC - 4(2)).

A useful discussion of this section of the TGAC is contained in the 2012/10/020 in relation to the product Hypercal (HERE).

With the above in mind, it is therefore useful to think of three tiers of claims:

  1. 1.      A "claim", a "statement" or an "implication" (per section 4(2) of the TGAC).  This would be a broad reference for which identification required by section 4(4) did not apply.  For example "this product relieves pain within 15 minutes.
  2. 2.      A "general statement about the evidence" (per the CRP discussion in complaint 2012/10/020) which is something less than publication of research results and does not trigger section 4(4). For example "four clinical trials have shown that this product relieves pain in 15 minutes".
  3. 3.      "Publication of research results" which is something more than a general statement about the evidence and which does trigger section of the TGAC. For example "in a 2011 trial involving 3,000 patients in Mexico, the majority of patients recorded statistically significant pain relief within 15 minutes".

Please note that this approach is consistent with the TGACC's approach in 2008 when recommending that the TGA make revisions to section 4(4). At that time, the TGACC recommended that the section be revised to read:

Publication of references to a specific research study must sufficiently identify the study as to allow consumers to access it.  Any direct financial sponsorship that has been provided by the sponsor of the product or the advertiser, where known, must be included in the advertisement.

What is scientific information?

What is scientific terminology?

Although the terms "scientific information" and "scientific terminology" are not defined in the TGAC, ASMI's view is that the words ought to be given their ordinary meaning. Also, they ought to be approached from the point of view of the reasonable person to whom the advertisement is directed (per section 3(2) of the TGAC).

The requirement for "scientific information" to be accurate, balanced and not misleading, is simply a re-statement of the requirements in sections 4(1)(b) and 4(2)(c) , so there is no additional requirement particular to scientific information. It is therefore not critical to determine what "scientific information" is because it has to be treated exactly the same as all other information.

The requirements for the "scientific terminology" to be appropriate, clearly communicated and able to be readily understood by the audience are additional to those of sections 4(1)(b) and 4(2)(c). So it is important to firstly identify what scientific terminology is and, secondly to make sure that it is communicated in a manner consistent with section 4(4).  In ASMI's view, what amounts to scientific terminology will depend on the audience, but in any event it would involve technical terms that are not commonly used by the audience and that may be out outside the normal l experience or knowledge of the audience members. If your advertisement includes such language then the requirements of section 4(4) will need to be met.

 

Q. Is it okay to provide incentives to pharmacy assistants to sell or recommend products?

A. Section 4(3) of the TGAC prohibits advertisements from including an incentive to pharmacy assistants to sell or recommend a product. Section 5.1.8 of the ASMI Code contains a similar prohibition. Together, these two Codes prohibit members from offering such incentives through any advertising medium.

This does not prevent ASMI members from offering incentives to pharmacy or retail assistants to participate in product training. 

 

Q. Is it okay to describe fish oil products as being 'mercury tested'? Or does this bring into play a breach of section 4(2)(d) of the Code (by being likely to bring about 'fear or distress'  in consumers)?

A. As outlined in the following summary, section 4(2)(d) does not prevent this claim from being made:

  • In 2004, ASMI refused an application to advertise fish oil capsules as '99.99999% mercury free'. On appeal, the TGA delegate (on the advice of the TGACC) confirmed this decision. The claim was refused on the basis that it implied that the goods were safe or that their use could not cause harm, breaching s 4(2)(i) of the TGAC. The delegate also determined that the claim constituted an unacceptable comparison (s 4(5)), as the statement was likely to give the impression that other fish oil products may be harmful.
  • The matter was again considered in 2008, when CHC refused the claim 'tested for pesticides and heavy metals including mercury'. The delegate confirmed this decision, taking into consideration advice from the TGACC (from the December 2008 meeting). CHC reasoned that the claim breached sections 4(2)(c), 4(2)(d), 4(2)(i) and 4(5) of the TGAC. They determined that the intrinsic safety of a product (including determinations about the presence or absence of mercury) in therapeutic goods was a market entry issue within the TGA's responsibility. By stating such claims in an advertisement, a misleading impression was created that other products may not be of comparable relative safety, breaching s 4(5). They also reasoned that the claim exploited the lack of knowledge of consumers as most consumers do not have a detailed knowledge of the various pre-market requirements which need to be satisfied about product safety prior to marketing authorisation being granted, breaching s 4(2)(d) of the TGAC. 
  • The 2008 decision was subject to a merits review by the Administrative Appeals Tribunal. The AAT set aside the decision of the delegate, and granted approval for a print advertisement which included the claim 'tested for pesticides and heavy metals including mercury'.  This decision was made in July 2009.

 

Q. When do the additional minimum requirements in 6(3)(c)(i) apply?

A. Section 6(3)(c)(i) of the TGAC introduces additional minimum requirements in relation to "direct marketing" and "internet marketing". This section introduces these new terms to the TGAC (neither of which is separately defined). We take a similar approach to interpreting the new terms in section 6(3)(c)(i) as we do in relation to the terms "scientific information", "scientific terminology", "publication" and "research results" in section 4(4) (see FAQ above). That is, when the drafters of the TGAC introduce new terms, these new terms do not mean the same things as the terms previously used in the TGAC. Importantly, the drafters used the word "marketing" as distinct from the word "advertising". It is therefore appropriate to conclude that internet marketing is not the same as internet advertising.

In ASMI's view, section 6(3)(c)(i) only applies where a product is being advertised AND being sold.

Section 6(3)(c)(i) does not apply where a product is only being advertised.

 

Q. Can you please provide clarity on who is and isn't a 'healthcare professional'?

A. 'Healthcare professional' is defined in section 42AA of the Therapeutic Goods Act. This was updated in 2009 to remove reference to veterinarians and scientists working in medical laboratories. The previous definition still appears as Appendix 2 of the TGAC.

Sponsors should note that section 4(6)(b)(iv) of the TGAC states that advertisements must not contain or imply endorsement 'by individuals, who are healthcare professionalsby way of their representationin advertisements or academic qualifications, and/or who are likely to be known as healthcare professionals by the reasonable person'.  Sponsors should be mindful that the average consumer may not be able to discern whether the talent in an advertisement is 'actually' a healthcare professional; ambiguity should be avoided. The following determination provides a useful examination:

Sensodyne Complaint 2013/05/009: HERE 

 

Q. Can you please clarify circumstances where a healthcare professional can promote a therapeutic good?

A. Promotion by healthcare professionals is permissible only with respect to availability, as per section 4(6)(b)(iii) of the TGAC. For instance, a pharmacist could relay the bland message 'the full range of product X is available at pharmacy Y'. This message must not include statements that imply that professional's endorsement of the product, such as 'I've got just the thing!'

 

Q. Can you please clarify circumstances where a healthcare facility or hospital can endorse a product?

A. Section 4(6)(a) states 'An advertisement may include reference to sponsorship of any government agency, hospital or other facility providing healthcare services, provided that sponsorship isexplicitly acknowledgedand isnot presented as an endorsement of a therapeutic good'. For instance, the claim 'company X is a proud sponsor of Sydney Children's Hospital' is acceptable (provided adequate supporting documentation is forwarded to the ASM).

Sections 4(6)(b)(i) and(ii) state that advertisements must not contain or imply endorsement by 'any government agency' or 'hospitals and other facilities providing healthcare services'. For example, the claim 'product X appears on Sydney Children's Hospital formulary' implies the Hospital's endorsement of that product, and is not compliant.

 

 Q. Can you please clarify circumstances where a professional body can endorse a product?

A. There are certain circumstances (set out in section 4(6)(b)(c) of the TGAC) where a peak healthcare professional body or association may endorse a product. The advertisement must name the body/association, the endorsement must be authenticated (this documentation to be forwarded to the ASM), the nature of the endorsement must be clearly disclosed, and the endorsement be based on an objective assessment of available scientific data supporting the use of that product. Where the endorsement is not based on an objective assessment, and the body/association has received valuable consideration for its endorsement, the advertisement must acknowledge that consideration.

For instance, an advertisement may contain a statement like 'product X is a recommended sunscreen of the Dermatological Society of Australia' (provided that that Society does not provide healthcare services). If the Society received payment for making that endorsement, the advertisement would need to disclose that payment.

 

Q. What is a "sample"?

A. A 'sample' is not defined in the Therapeutic Goods legislation. The TGAC previously referred to a 'free sample'. The word 'free' was removed after the CRP considered a series of advertisements offering samples of therapeutic goods for as little as five cents. An offer of a 'free trial' of a product would certainly be considered an offer of a sample.

Section 4(8) has long been taken to mean that there should be an exchange of valuable consideration in purchasing a therapeutic good.

This does not necessarily prohibit heavy discounting, especially in an era of discount pharmacy.

The TGACC has already recommended that this section of the Code be amended to refer to "an offer of a sample of a therapeutic good".  The revised s 4(8) would be phrased:

"An advertisement for therapeutic goods must not contain an offer of a sample of any therapeutic good, other than a sample of therapeutic devices and/or sunscreens."

 

Q. What are some of the issues with promotional activities such as "Buy 1 get 1 free"?

'Buy one get one free' and 'buy this, get that' promotions should be considered in light of the principles of Quality Use of Medicines. QUM is defined in the ASMI Code as 'selecting diagnostic and treatment options wisely based on the best available evidence and the consumer's needs; choosing suitable therapeutic products if this is considered necessary; and using therapeutic products safely and effectively'.  The consumer should autonomously determine whether a specific therapeutic good is actually appropriate or necessary for them.

Value offers may enliven a breach of s 4(2)(f) of the TGAC, by encouraging inappropriate or excessive use of a therapeutic good. However, it can be difficult to establish whether a promotion actually encourages inappropriate or excessiveuseof a product; this clause doesn't necessarily prohibit 'excessive' purchase. 

Generally, a 'buy one get one free' offer of the same product will comply with the TGAC, as long as the promotion does not incentivise excessive/inappropriate use.

 

Q. What about "Buy this and get that" and gifts with purchase?

'Buy this, get that' promotions are regarded differently, as the second product is not the same as the product purchased. Even if the second product is from the same therapeutic class, the consumer has not self-selected it. As such, it would be considered a sample of a therapeutic good, and breach s 4(8) of the TGAC.

'Gifts with purchase' (of non-therapeutic goods) are generally compliant, provided the promotion is not likely to encourage inappropriate or excessiveuseof the product. These gifts are typically of nominal value.

 

Q. Do promotions including offers of 'money back guarantees' or '100% cash back' comply with the Code?

An advertisement containing a 'money back guarantee' may comply with the Therapeutic Goods Advertising Code, if the context of the advertisement in which it appears clearly indicates that the advertised product may not work for all consumers. This will avoid breaching s 4(2)(h) of the TGAC (an advertisement for therapeutic goods must not contain any claim, statement or implication that it is effective in all cases of a condition). A 'money back guarantee' will usually not be taken to breach s 4(8) of the TGAC, as the expectation is that the product has been purchased.

'100% cash back' offers, however, are more likely to enliven a breach of s 4(8) of the TGAC. Depending on context, these promotions tend not to emphasise the possibility that the product may not work for every consumer, but rather effect a 'free trial', or offer of a sample, of the advertised product. 

 

Q. Do advertisements require mandatory statement(s) if one or more websites are included? Inclusion of the recommended information in internet marketing is not always possible due to issues such as space restrictions.

A. Digital advertising is not exempted from the requirement to display mandatory statements. It is useful to embed the mandatory statements in a website template. This ensures that the statements appear on every page featuring the advertised product. These can be included at the bottom of a page, provided they are clear and prominent.

While all advertisements must include the mandatory statements, some pragmatism is necessary. ASMI considers that it would be reasonable for a digital 'banner' ad to not include the mandatory statements, so long as these were visible on a full advertising webpage, accessed by clicking on the banner.

The CRP considered an example of 'direct marketing' and 'internet marketing' issued by Chemist Warehouse in Complaint 2012/08/007. The Panel found that this email advertisement lacked the minimum requirements of 'direct' and 'internet' marketing set out in s 6(3)(c)(i) of the Code.

The CRP's determination in Complaint 2012/08/007 can be found HERE

There have not been any recent determinations published where the CRP has considered the mandatory statements appearing in digital marketing is sufficiently 'prominently displayed or communicated'. 

 

Q.  Are there specific mandatory statements forvitamins and weigh loss products? For example is the statement "vitamin supplements should not replace a balanced diet" mandatory for vitamin products under section 7 of the TGAC?

A. The TGAC sets out 'vitamins' and 'weight management' as special categories. However, there is no formal requirement to include statements like 'Vitamins do not replace a balanced diet', or 'To be used in conjunction with a calorie controlled diet'. These are not 'mandatory' statements. Sponsors should be mindful of the wording of section 7 of the TGAC, and the need to ensure that the messages in the advertisement itself are compliant; the inclusion of a pseudo-mandatory statement like 'vitamins do not replace a balanced diet' will be inadequate if the advertisement itself tells a different narrative.

 

Q. Which body - CHC or ASMI - is to approve a print ad if both complementary and OTC products are advertised in the same advertisement?

A. If a print advertisement (appearing in mainstream media) contains complementary and OTC products, it will require approval by both ASMI and CHC. These bodies are only empowered to review print advertising of either OTC or complementary medicines; only OTC products will be considered in an ASMI review and only complementary products will be considered in a CHC review. Sponsors should be aware that these advertisements must display both CHC and ASMI approval numbers, and be mindful of approval timelines.

 

Q. Is there a difference between "Clinically proven", "clinically tested", "clinically trialled" etc

A. The CRP has indicated that "clinically proven" and "clinically tested" are essentially the same claim and both require the same high level of proof. The CRP's view is expressed in the following three determinations:

Remifemin Complaint 2012/06/024 (see paragraphs 35 to 39): HERE

Actinica Complaint 2012/07/005 (see paragraph 23): HERE

Swisse Complaints 2011/11/001 and 2011/11/009 (especially paragraph 53): HERE

The CRP decision highlight looking at "clinically proven" is also useful and is available HERE

 

Q. When does a catalogue become "mainstream"?

A. A publication is classified as mainstream if it fits the definition in section 3 of theTherapeutic Goods Act. Note that this definition is about thecontentof the publication and not the method of distribution. Publication without approval is a breach of section 42C. A catalogue on its own therefore does not require approval (unless the method of distribution makes it "mainstream"). Adding content to a catalogue will make it more like a mainstream publication. For example, the inclusion of things like recipes, editorials, competitions, news etc. is more likely to bring the publication within the definition in the Act.

If the publication fits the definition of "mainstream" then the individual advertisements should each be approved.

The following two CRP determinations provide useful examinations:

Algicaps Complaint 2012/08/006: HERE

SAFE Products Compliant 2012/02/016: HERE

 

Q. What would constitute an advertisement for an "unbranded therapeutic good" under section 6(1)(a) of the TGAC?

A. The only reference to "unbranded therapeutic goods" is in the TGAC. This term appears interchangeable with 'generic information', which is referenced only in the Therapeutic Goods Regulations.

The TGACC should consider replacing the term 'unbranded therapeutic goods' with 'generic information'. The definition of 'generic information' should be included in section 2 ('definitions') of the TGAC. Consistent wording would ease confusion.      

 

Q. What is meant by 'generic information'?

'Generic information' is defined in the Therapeutic Goods Act as follows:

'Generic information', in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, about the composition, properties or other characteristics of therapeutic goods, but does not include:

                     (a)  an advertisement about the goods; or

                     (b)  generic information included in an advertisement about the goods; or

                     (c)  bona fide news.

Generic information must comply with subsections 4(1), (2), (3), (4), (5) and (6) of the Therapeutic Goods Advertising Code (per section 42DP(1)(b) of the Therapeutic Goods Act, and regulation 8A  of the Therapeutic Goods Regulations).  Note that this includes the prohibition on healthcare professional endorsement.

As generic information excludes 'advertisement', there is no requirement to seek formal pre-approval. However, complaints about generic information can be considered by the Complaints Resolution Panel.

 

Q. To what products does section 6(3)(f) of the TGAC apply?

A. Section 6(3)(f) applies to products which can be advertised to consumers, that are not included in schedule 2 (Pharmacy Medicine) or Schedule 3 (Pharmacist Only Medicine) and that are only available on the recommendation of a healthcare professional. Some examples of these products include:

  • Practitioner Only Complementary Medicines
  • Contrast Media
  • Folic Acid injections
  • Vitamin C Injections

 

Q. Are statutory declarations required in order to substantiate testimonials?

A. No. Section 7 of the TGAC requires testimonials to be "documented, genuine, not misleading and illustrate typical cases only". The TGAC does not specify how the testimonials are to be documented (only that they must be). While it might be best-practice to use a statutory declaration to capture the testimonial, it is not mandatory and in some cases it may not be possible to obtain one. On this point it is worth noting that although section 29 of the Australian Consumer Law contains specific coverage of testimonials, neither the Act nor the ACCC mandates the use of statutory declarations to substantiate testimonials.

 

Q. Do 'media engagement' activities need to comply with the TGAC?

A. Sponsors should be mindful of the broad definition of 'advertisement' when issuing media statements. The Therapeutic Goods legislative definition of 'advertisement' includes 'any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods'. As such, media engagement is a form of advertising, and content should comply with the TGAC. This activity does not fall within the definition of 'specified media', so does not require pre-approval. The ASMI Code has long included 'press releases' as a 'below the line' category to be reviewed by the Promotional Monitoring Panel.

The ASMI Complaints Panel has considered several complaints involving public relations activities (or 'media engagement'). In the 2006 complaint, Nicorette v Nicabate, the Panel noted that 'press releases' fall within the ASMI Code definition of 'advertisement/promotion'. The Panel determined that when a publisher publishes matter derived from a press release or other form of communication issued by a sponsor, the sponsor is responsible for anything that finds its way from the press release (or other communication) into the publication. They noted that the CRP had taken a similar approach, finding both publisher and sponsor responsible for a consumer advertisement derived from a press release (in complaint 7-1104). In a later complaint, Somac v Pariet (2011), the Panel determined that any content provided by a sponsor to media (not necessarily in the form of a press release) is considered advertising, and should comply with the TGAC.

In Nicorette v Nicabate (2006), the Panel clarified that while sponsors are responsible for the content of media engagement materials, they cannot be held accountable for editorial omissions, or misinterpretations. However, sponsors are accountable for inferences reasonably drawn from a media release.