FreelV Australia

1 May 2018

Ms Leanne McCauley Advertising Compliance Unit Regulatory Practice, Education and Compliance Branch Therapeutic Goods Administration PO Box 100 WODEN ACT 2606 By email: advertising.consultation@health.gov.au

Dear Ms McCauley,

Therapeutic Goods Advertising Code 2018

44 Avenue Road

Mosman NSW

Australia 2088

T : 61 2 8968 7100

F : 61 2 9969 3520

W : freetv.com .au

Thank you for the opportunity to comment on the draft Therapeutic Goods Advertising Code 2018 (the Draft Code) and the Therapeutic Goods Advertising Code 2018 - Guidance on applying the Code when advertising therapeutic goods to the public (Guidance Document).

Free TV Australia (Free TV) is the peak industry body representing Australia's commercial free-to­air television broadcasting licensees. Commercial free-to-air television reaches 13 million Australians on average every day. At no cost to the public, our members provide a diverse range of content, including public health information, to the public.

Free TV recognises the importance of ensuring that marketing and advertising promotes the safe and effective use of therapeutic goods and does not mislead or deceive consumers. For this reason, Free TV supports a revised Code which is robust, clear and which contains requirements that are unambiguous.

However, the regulatory framework must also recognise and promote broadcasters' important role in disseminating health related information to the public via news, current affairs and other programming . This is particularly important given the increased penalties recently introduced for breaches of the Act and the Code. In its current form, the Draft Code risks disincentivising the dissemination of health related information via the broadcast medium.

In summary, our key concerns in relation to the Draft Code and Guidance Document are:

• The Code does not clearly distinguish between public interest information on the one hand and advertising on the other. Public interest and entertainment programming are not marketing and should be clearly excluded from the application of the Code.

• Guidance should also be provided in relation to the definition of 'advertise' to make clear that it does not include bona fide news, public interest or entertainment programming.

• The draft provisions in relation to testimonials could lead to code breaches and criminal penalties in circumstances where a testimonial overall is not misleading. Testimonials should be subject to a general requirement that they be documented, genuine and not misleading only.

• The current reference to Free TV Australia in the Guidance Document is incorrect and requires amendment;

• The Guidance Document as currently drafted is incomplete with a number of areas being flagged as 'under development'. We request an opportunity to consult on the final consultation documents once they have been completed .

We detail these concerns as well as other drafting issues below.

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Bona fide news, public interest or entertainment programs should be exempt

Currently, the Therapeutic Goods Advertising Code 2015 (the Code) makes clear that it does not apply to bona fide news, public interest or entertainment programs. Clause 3(1 )(c) of the the Code recognises this. It provides:

"This Code does not apply to bona fide news, public interest or entertainment programs;"

This is an important exemption that enables broadcasters to broadcast health-related programs that inform the public about public health issues, medicines and products.

The 2018 Draft Code does not include this provision. Clause 6(6) of the Draft Code instead provides:

"However, this Code does not apply to genuine news that is broadcast or published in print by a person mentioned in subsection (7), or material published online that is a replication of such news."

This exemption enables broadcasters to broadcast health-related stories that inform the public about public health issues, medicines and products. Free TV is extremely concerned that removal of the references to public interest and entertainment programs will reduce the broadcast of health-related information to the public and restrict the free flow of information to the public on matters of publ ic interest. The revised provision suggests that health related stories broadcast in programs other than new programs may not fall within the exception, despite the fact that Australians turn to a range of programs on commercial free-to-air television to provide them with health-related information. We provide a few examples of such programs below.

Case study

The Project broadcast a story on the HPV vaccine and the decline in the rates of Human Papillomavirus (HPV) - the infection that causes cervical cancers - as a result of the vaccine. The story disseminated detailed information in relation to the benefits of the vaccine to the public and due to the show's format, was able to provide a more detailed story than might be possible in a traditional news format. 1

Case study

Studio 10 interviewed Dr Vicky Sheppeard, Director of Communicable Diseases with NSW Health to discuss a Hepatitis A outbreak caused by infected imported frozen pomegranate sold in supermarkets. In the course of the show images are included and references made to Hepatitis A vaccines.2

Case study

Today Extra broadcasts a 'Your Health' segment every Sunday. It recently broadcast a story on the tlu, providing information about flu vaccines, discussing the benefits of the vaccine as well as risks and drawbacks, the cost of the vaccine and referencing where the public could go to for further information.3

1 See: https ://tenplay. com .au/cha n nel-ten/the-projecUtop-stories-march-2018/e Ii mi nation-of-cervical-cancer-in-sight 2 See: https://tenplay.com .au/channel-ten/stud io-1 0/extra/season-2018/hepatitis-outbreak 3 See: https://www.9now.com.au/today/2017/extras

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Case study

Today Tonight broadcast a story on proton therapy, a life-saving cancer treatment and a family's experience supporting their daughter through the treatment process. During the course of the broadcast, references were made and images shown of the treatment process the patient underwent. As a result of the segment, a substantial amount of money was atso donated for the treatment via 'go fund me'.4

These examples demonstrate the value of broadcasters being able to disseminate health-related information not only via traditional news services, but via current affairs and alternative program formats as well. There is no policy basis for distinguishing between the dissemination of health information via a traditional news style format on the one hand and alternative formats on the other. Health information is equally valuable regardless of where viewers choose to obtain that information from. There is no basis for making health information broadcast via alternative news formats much more difficult than traditional news formats .

The references to public interest and entertainment program should therefore be re-inserted to make it clear that these programs are not considered to be advertising. Removing the exemption for public interest and entertainment programs would discourage broadcasters from broadcasting health information via these types of programs because it would mean that broadcasters would need to undertake additional regulatory reviews of the material to be broadcast. This would require more time to be spent reviewing the material in circumstances where program producers are often working within limited time-frames to get segments to air.

Critically, it would also subject broadcasters to much higher legal risk in relation to health material broadcast on these types of programs. This is particularly so given the Therapeutic Goods amendment (2017 Measures No. 1) Bill 2017 introduced new offence provisions which makes broadcasters criminally liable for breaches of the Code. 5 Broadcasters are particularly at risk because of a condition of their broadcasting licences prescribed by cl 7(1)(h) of Schedule 2 to the Broadcasting Services Act. This licence condition has been interpreted very broadly to mean that a broadcaster can be held in breach of its broadcasting licence if the broadcasting service which it operates is used in the commission of an offence against any provision of a State, Territory or Federal law whether or not the offence was commissioned by the broadcaster and whether or not the offence has been prosecuted by the relevant regulatory authority.6 If the risk of running health related stories or informing the public about new medicines is too high, broadcasters will simply avoid running these stories, or run them in only limited circumstances where the legal risk is manageable.

Excluding public interest and entertainment programs from the application of the Draft Code would not remove broadcaster liability in circumstances where broadcast material strays from 'bona fide news, public interest or entertainment programming', into advertising, and there are strict offence and penalty provisions under the Therapeutic Goods Act (the Act) to cover these cases. For example, s 42DLA and s 42 DLB of the Act prohibit advertising therapeutic goods in a range of circumstances. As the Code regulates marketing and advertising, which is not the purpose of news, current affairs or entertainment programs, and the Act deals with what constitutes advertising material and the consequences of not appropriately identifying material as advertising, the Act more appropriately addresses these concerns.

4 https://www.todaytonightadelaide.corn.au/stories/proton-therapy 5 See s 420M, s 42 OMA. 6 The penalties for breach of a licence condition include suspension or cancellation of a broadcaster's broadcasting licence.

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The Therapeutic Goods Administration's comparison table between the provisions of the 2015 Code provisions and 2018 Draft Code identifies the reason for the removal of the references to public interest and entertainment programs as a recommendation by the Complaints Resolution Panel (CRP).7 However as Free TV understands it, the basis for the CRP recommendation was an investigation in relation to a breach of the existing provisions of the Act. There was no suggestion that the provisions of the Act would be insufficient to deal with the circumstances that arose in this investigation and the broadcaster involved swiftly removed the material in question as a result. This example demonstrates that the existing TGA regulatory process operated as intended.

Recommendation: Public interest and entertainment programs should be clearly excluded from the application of the Draft Code in the same way as news programs in clause 6(6). The dissemination of health information to the public via these programs is equally valuable to the public.

Clarification of the definition of 'advertise'

There has been some confusion in relation to the scope of the definition of 'advertisement' under the Act previously and Free TV is concerned that these issues be clarified in the context of the change to the new definition of 'advertise' and the enhanced penalty provisions under the amendment to the Act last year. 8 Previous decisions of the CRP have suggested that an assessment of whether material is advertising material requires a consideration of "whether the material, in the eyes of an ordinary and reasonable viewer, ought to be regarded as "intended ... to promote the use or supply" of the product in question.9

This means that the subjective intention of the broadcaster has been disregarded even in circumstances where there has been no commercial arrangement made between a broadcaster and a product manufacturer/supplier to promote or advertise a product and no other evidence of an intention to promote. Instead, the CRP has construed the definition to imply a test based on the 'objective' viewpoint of the ordinary and reasonable viewer, and whether they would reasonably perceive an intention to promote the use or supply of the product in question.

In Free TV's view, this approach is impractical because it does not allow for broadcasters to make editorial decisions in relation to the stories that they broadcast. For example, if a broadcaster uses a pack shot of a therapeutic good in a story, that should not be sufficient to bring the story within the definition of 'advertising'. In addition, the test being the "objective" viewpoint of the ordinary and reasonable viewer means that broadcasters are at risk in programs where they may provide favourable commentary or opinions regarding certain products, even though those viewpoints may be provided simply on the basis of editorial relevance or honest appraisal - without any commercial arrangement in place. This means that any positive appraisals of products could be interpreted, on an "objective" basis, as advertising in breach of the Code and broadcasters are disincentivised from providing positive or favourable appraisals of products, even though this may be wholly appropriate commentary in relation to certain products. Particularly in the case of current affairs programs, that are permitted under the Commercial Television Industry Code of Practice to take an editorial stance - that means that in relation to therapeutic goods, given they may be penalised for taking a positive

7 See: https ://www. tga. gov. a u/sites/defaulUfiles/com parison-between-the-therapeutic-qoods-advertisinq-code-2015-and­the-proposed-2018-code. pdf 8 Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017. 9 See for example, CRP Determination 2011-03-019 Optiderma Opal A Products (2 July 2011), CRP Determination 2011-10-031 (2) McArthur Natural Prodcuts (Seven Network)(17 May 2012), CRP Determination 2013-04-001 Nagestic Forte and -002 Blooms Health Products (25 July 2013), CRP Determination 2017-02-015.

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editorial stance, the only "safe" editorial stance is to criticise those products rather than provid ing an honest appraisal.

The CRP's position is also inconsistent with other advertising regulations and imposes two inconsistent sets of regulations on broadcasters in respect of the same content. The Commercial Television Industry Code of Practice recognises commercial arrangements to endorse or feature a third party's products or services only as those where they are in return for payment or other valuable consideration. 10 The scope of what is considered to be advertising under the Act, on the wording of the provisions, is much broader and does not exclude the use of references to third party products in bona fide news, public interest or entertainment programs where no consideration has been made. This means that broadcasters could be subject to two different sets of regulatory processes based on inconsistent rules, each with serious penalties attached. Free TV notes that the very broad scope of this legislation and the serious consequences for breaches of the Act also highlights the issue of ensuring due process in CRP investigations and ensuring adequate oversight of the CRP exists.

Recommendations:

Clarification should be provided in the Draft Code and Guidance Document that:

• The definition of 'advertise' does not include genuine news, public interest or entertainment programming.

• Where it is unclear whether material is either bona fide news, public interest or entertainment programming, or advertising, the following factors should weigh against a finding that the material is advertising:

);:,- The intention of the broadcaster in broadcasting the relevant material was to disseminate health related information to the public rather than to advertise;

);:,- The broadcaster did not obtain any consideration for broadcasting the material;

);:,- The broadcaster had no commercial interest in the relevant business which was referenced in the broadcast segment.

• Where a news or entertainment program reports on a particular product, this should not be considered determinative of whether program material is advertising or not.

Liability for breaches

The Guidance Document on page 15 states that liability lies with 'the person who paid for or otherwise authorised the advertising'. This is consistent with Free TV's understanding of the intention under the Act - broadcasters are subject to exemptions under s 42DLB(10) and s 42DMA(2) which make it clear that they are not liable for civil penalties where, as a result of steps taken, it was reasonable to assume that the Act would not be contravened.

However the Guidance Document on page 15 provides the example of a shelf wobbler in a pharmacy, stating 'the primary responsibility for compliance lies with the pharmacy owner who authorised public display of the item' . This suggests that it is the publisher, or the last person who handles the advertising, that will be liable for breaches under the Act, and appears to be inconsistent

1° Commercial Television Industry Code of Practice, Clause 4.

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with the intention of the exemptions provided in the Act, as well as other advertising laws and regulations which recognise that the person who paid for or otherwise authorised the advertising is the advertiser. This example should be clarified in the Guidance Document to make this clear and/or additional examples should be included to demonstrate how the exemptions at s 42DLB(10) and s 42DMA(2) operate.

Recommendations: Clarification should be provided in the Draft Code and Guidance Document that Broadcasters will not be liable for breaches under the Act or Code where, as a result of steps taken, it was reasonable to assume that an advertisement complied with the Code.

Testimonials

The 2018 Draft Code introduces a number of additional requirements in relation to testimonials. Clause 7 of the 2015 Code required testimonials to be documented, genuine, not misleading and illustrate typical cases only. Clause 17 under the new Draft Code does not contain such an overarching requirement but instead contains a number of highly prescriptive requirements which would determine whether or not a testimonial is misleading or not.

In Free TV's view, the requirements in new clause 17 should be removed and instead be included in the Guidance Document. They should not be included as individual requirements in the Draft Code which, upon breach, give rise to significant penalties including criminal offence provisions. Including these requirements is non-sensical because the absence of any one of the requirements in clause 17 may not on its own make an advertisement misleading. For example, the fact that a person may be a relative of a person involved in the production of certain goods should be a factor to consider in determining whether or not a testimonial is misleading, however it should not be determinative and should not on its own give rise to criminal penalty provisions.

The section on Testimonials in the Guidance Document provides that, 'A statutory declaration in relation to a testimonial should be made ( and therefore dated) before the advertisement featuring it.' There is no requirement in the Draft Code for statutory declarations to be made in relation to testimonials, nor should there be. Such a requirement would be a significant imposition on advertisers and does not address the issue that appears to have arisen in a number of recent CRP determinations, which appears to be a lack of documentation in relation to testimonials, in breach of the existing requirement under clause 7 of the 2015 Code. Requiring a different form of documentation to be provided (a statutory declaration) does not address this issue. Given criminal penalty provisions now apply for breaches of the 2018 Draft Code as well as the Act, an additional requirement for a statutory declaration serves no purpose and does not promote compliance. 11

Recommendations:

• Clause 17 of the 2018 Draft Code should be removed. Testimonials should be subject to a general requirement that they be documented, genuine and not misleading.

• The requirements currently in clause 17 of the 2018 Draft Code should be included in the Guidance Document as factors that the Therapeutic Goods Administration will consider in determining whether or not a Testimonial is in fact misleading.

• The reference to the requirement that a statutory declaration should be made in relation to a testimonial should be removed.

11 Therapeutic Goods Act, S 42DM.

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Advertising to children

The Draft Code proscribes directing advertising to children under the age of 12. The Draft Code should be amended to include the word 'primarily' in subsections (1) and (2) of clause 19, so that it proscribes advertising which is 'directed primarily to children'. This is consistent with a number of other advertising standards, 12 and would clarify that there is a distinction between advertising which is directed towards children (i.e. children are the target audience) and advertising which is directed to adults but may also be seen by children. 13 Free TV notes that the section on advertising to children in the Guidance Document is still under development. We would welcome further consultation on this once the Guidance Document has been completed.

Recommendation:

Clause 19 of the Draft Code should be amended to clarify that the Code is intending to proscribe advertising that is 'primarily' directed to children.

Required statements - Schedule 3 medicines

Free TV was an active participant in the working group meetings that led to the drafting of the required statement for advertising pharmacist only medication. In addition, we provided the Therapeutic Goods Administration with a submission on the consultation paper in October 2017 that noted our support for responsible advertising of Schedule 3 medicines that reinforces the role of the health care professional in the consumer's decision as to whether a treatment is right for them. As we noted during the working group meetings, overly prescriptive and lengthy required statements detract from this central message.

The current draft wording of "ask your pharmacist-they must decide if this product is right for you" is more detailed than the required wording in the existing Code. While we acknowledge that there is a diversity of views on this issue and that the wording in the Draft Code represents a compromise position, Free TV recommends that the required statement be amended to "ask your pharmacist if this product is right for you", or alternatively, "your pharmacist will decide if this product is right for you."

Recommendation:

The required statement in relation to schedule 3 medicines should be amended to "ask your pharmacist if this product is rioht for vou".

Reference to Free TV Australia incorrect

Page 7 of the Guidance Document currently provides that, "Advertisements to appear on free-to-air television require clearance by Free TV Australia's Commercial Advice". This is incorrect. Free TV Australia provides a classification and review service for free-to-air broadcasters. However, it is not compulsory for advertisements to be classified and reviewed via Free TV's service. We suggest amending this sentence to read: "Advertisements to appear on free-to-air television are required to be classified. Free TV Australia's Commercial Advice provides a classification and review service for free- to- air broadcasters and advertisers."

12 For example, the AANA Code of Ethics, the AANA, the AANA Code of Advertising and Marketing Communications to Children. 13 Free TV also supports the submission of the AANA in this regard .

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Other drafting comments

• Appendix 6 of the 2015 Code includes a table of diseases, conditions, ailments and defects for which advertising of serious forms is restricted. This table has not been included in the 2018 Draft Code or Guidance Document. As it provides useful guidance in determining the types of diseases, conditions, ailments and defects that, if referenced within an advertisement, requires approval from the Secretary of the Department of Health, Free TV recommends including this table in the Guidance Document.

• Clause 11 (3) of the 2018 Draft Code contains a grammatical error. It currently states, 'an advertisement for medical devices or therapeutic goods that are not medicines, medical devices or biologicals must contain the following ... ' This should read, 'an advertisement for medical devices or therapeutic goods that are not medicines or biologicals must contain the following ... '

• The Guidance Document on page 10 in relation to the definition of 'prominently displayed or communicated', provides that 'the Code does not require all mandatory information in an advertisement to be prominently displayed or communicated'. This introduces uncertainty in relation to the requirement under the Code. The Guidance Document should provide guidance on what aspects of the mandatory statement are required to be prominently displayed or how this is intended to apply.

• The Guidance Document on page 19 (Section 9, Accuracy), does not provide any guidance on the types of claims that are considered to be 'therapeutic use claims', the types of claims that are considered to be 'other types of claims', or the distinction between the two. It would be useful for the Guidance Document to provide a list of common therapeutic use claims. In particular, it would be useful to have guidance in relation to what constitutes 'influencing, inhibiting or modifying physiological processes', by including a non-exhaustive list of examples of terms or phrases.

• In the same section, also on page 19, the Guidance Document provides that '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 will mislead consumers'. It would be useful for the Guidance Document to include the reasons why this example would not comply and at what point scientific information would be considered to be acceptable.

• The Guidance Document at page 22 (Section 10, Effect) under the heading 'Encouraging inappropriate or excessive use' is still under development however it notes that once complete, it should provide guidance to advertisers on whether promotions such as 'two-for­one', 'heavy discounting' and similar offers are likely to contravene this section. Free TV notes that, while inappropriate or excessive use of therapeutic goods is not in the public interest, discounted prices and other promotional measures do not encourage excessive use of therapeutic goods but rather ensures consumers receive appropriately priced medicines and are aware of the fact that they can get medicines for these prices. This should be acknowledged in this section of the Guidance Document. In a competitive marketplace, advertisers should not be punished for remaining competitive with various promotional techniques especially when it is unlikely these techniques encourage inappropriate or excessive use of therapeutic goods.

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Contact

If you have any queries or wish to discuss any of the matters raised in this letter, please contact me on .

Your sincerely

Free TV Australia

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