Health World Limited and Minister for Health and Ageing
[2013] AATA 388
[2013] AATA 388
Division GENERAL ADMINISTRATIVE DIVISION File Number(s)
2012/4299
Re
Health World Limited
APPLICANT
And
Minister for Health and Ageing
RESPONDENT
DECISION
Tribunal Deputy President P E Hack SC, Senior Member RG Kenny, Dr GJ Maynard (Member)
Date 7 June 2013 Place Brisbane The decision under review is set aside and a decision substituted that the initial decision of 27 April 2012 be revoked.
...........................................................................
Deputy President P E Hack SC
CATCHWORDS
HEALTH AND COMMUNITY SERVICES – THERAPEUTIC GOODS – whether advertisement breached legislative scheme – whether restricted representation – whether cystitis is a urogenital disease – whether cystitis is a serious form of urogenital disease – whether contained correct and balanced statements – whether contained verified claims – whether likely to arouse unwarranted and unrealistic expectations – whether likely to lead to self-diagnosing and inappropriately treating serious disease – whether likely to mislead – decision set aside – initial decision revoked
LEGISLATION
Therapeutic Goods Act 1989 (Cth), Pt 5-1, ss 42DD, 42DL(1)(c)
Therapeutic Good Advertising Code 2007, paras 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), 5(2), Pt 2 of Appendix 6
Therapeutic Goods Regulations 1990
REASONS FOR DECISION
Deputy President P E Hack SC, Senior Member RG Kenny, Dr GJ Maynard (Member)
7 June 2013
Introduction
The applicant, Health World Limited, is the supplier of a number of medicinal products including a tablet called Urinary Tract Support (UTS). UTS satisfies the description of “therapeutic goods” in the Therapeutic Goods Act 1989 (Cth) (the Act).
At least up until 2012 Health World advertised UTS in a variety of ways, including on its website. In 2010 a complaint was made to the Therapeutic Goods Administration (TGA) about Health World's advertising of UTS on three website addresses. It will suffice for present purposes to say that it was alleged, and subsequently found, that the advertisement[1] breached the Act and the Therapeutic Goods Advertising Code 2007 (the Code), a legislative instrument authorised by s 42BAA of the Act. Following a complex process of internal review, described in greater detail below, a decision was made on 28 August 2012 by a delegate of the respondent, the Minister for Health and Ageing, that required Health World to withdraw the advertisement, to withdraw, and not use, certain representations about UTS, and to arrange for the publication of a retraction using a form of words devised by the delegate.
[1]As appears in paragraph 21 below there were three separate pages however the decision-making processes to date and the submissions of the parties have described them as a single advertisement. We shall continue to do so except where necessary to distinguish between pages.
Health World now seeks a review of the delegate’s decision.
The legislative scheme
It is as well to start with reference to the Act and other legislative instruments that are relevant to these proceedings.
It is not in issue that UTS satisfies the description of “therapeutic goods” in s 3 of the Act; it is undoubtedly a product likely to be taken for therapeutic use, the term defined as including use in, or in connection with, preventing, curing or alleviating disease, ailment or defect in persons.
The advertising of therapeutic goods is regulated by Part 5-1 of the Act (headed “Advertising and generic information”), the Therapeutic Goods Regulations 1990 (the Regulations) and, in particular, Part 2 of the Regulations, and the Code.
Section 42BAA of the Act allows the Minister, by legislative instrument, to “make a code relating to advertisements about therapeutic goods”. The Code was made by the then Assistant Minister for Health and Ageing on 26 February 2007.
The Act recognises two categories of advertising – advertising which includes what is described as a “restricted representation” and other advertising. Section 42DD of the Act describes a restricted representation as,
… a representation in an advertisement about therapeutic goods that refers to a form of a disease, condition, ailment or defect identified in a part of the Therapeutic Goods Advertising Code as a serious form of a disease, condition, ailment or defect…
Advertising which includes a restricted representation is dealt with by Division 3 of Part 5-1 of Chapter 5 of the Act. Approval for the making of a restricted representation must be sought and obtained from the Secretary. Division 3A of Part 5-1 deals with advertisements for which an approval is not required.
Section 42DL of the Act prohibits the publication or broadcast of an advertisement about therapeutic goods,
(c)that contains a restricted representation, about those goods, the use of which has not been approved under subsection 42DF(1) or permitted under subsection 42DK(1)…
The Code has the stated object of ensuring,
… that the marketing and advertising of therapeutic goods to consumers is conducted in a manner that promotes the quality use of therapeutic goods, is socially responsible and does not mislead or deceive the consumer.
Paragraph 3(2) of the Code is in these terms,
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.
Paragraph 4 of the Code is headed “General Principles”. The following provisions within it are relevant,
(1)An advertisement for therapeutic goods must:
(a)…
(b)contain correct and balanced statements only and claims which the sponsor has already verified.
(2)An advertisement for therapeutic goods must not:
(a)be likely to arouse unwarranted and unrealistic expectations of product effectiveness;
(b)be likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases;
(c)mislead, or be likely to mislead, directly or by implication or through emphasis, comparisons, contrasts or omissions;
…
Paragraph 5 of the Code is headed “Prohibitions”. That part relied on by the Minister provides,
(2)An advertisement for therapeutic goods must not refer, expressly or by implication, to serious forms of diseases, conditions, ailments or defects specified in Part 2 of Appendix 6, unless prior approval is given under the Therapeutic Goods Act 1989.
Part 2 of Appendix 6 is in these terms:
Part 2 – Restricted Representations
An advertisement for therapeutic goods may refer, expressly or by implication, to a disease, condition, ailment or defect specified in Table 1, provided that prior approval is obtained for such a reference. Approval may be obtained from the TGA, upon recommendation from the TGACC and appropriate expert committee or committees.
Table 1. Diseases, conditions, ailments and defects for which the advertising of serious forms is restricted
·Cardiovascular diseases
·Dental and periodontal diseases
·Diseases of joint, bone, collagen, and rheumatic disease
·Diseases of the eye or ear likely to lead to blindness or deafness
·Diseases of the liver, biliary system or pancreas
·Endocrine diseases and conditions including diabetes and prostatic disease
·Gastrointestinal diseases or disorders
·Haematological diseases
·Infectious diseases
·Immunological diseases
·Mental disturbances
·Metabolic disorders
·Musculo-skeletal diseases
·Nervous system diseases
·Poisoning, venomous bites and stings
·Renal diseases
·Respiratory diseases
·Skin diseases
·Substance dependence
·Urogenital diseases and conditions
Serious in the context of this table will mean forms of those diseases, conditions, ailments or defects which are:
· Generally accepted not to be appropriate to be diagnosed and/or treated without consulting a suitably qualified healthcare professional, and/or
·Generally accepted to be beyond the ability of the average consumer to evaluate accurately and to treat safely without regular supervision by a qualified healthcare professional.
Given one of the issues raised by the parties it is necessary to have regard to the statutory scheme for the consideration and resolution of complaints. Section 42R of the Regulations establishes an entity called the Complaints Resolution Panel (the Panel). Section 42S confers on the Panel the functions of receiving and considering complaints about advertisements and generic information and taking action and making recommendations to the Secretary of the Department of Health and Ageing on the complaints. It is not necessary for present purposes to examine the mechanism for the Panel to investigate complaints. It is sufficient to note that the Panel, having investigated a complaint about an advertisement, has the power conferred by s 42ZCAI of the Regulations in these terms:
(1) If, in relation to a complaint about an advertisement, the Panel is satisfied that there has been a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code, the Panel may request in writing the person apparently responsible to do one or more of the following:
(a)withdraw the advertisement;
(b)publish a retraction;
(c)publish a correction;
(d)withdraw a particular claim or representation made by the advertisement, and give the Panel a written undertaking not to use that claim or representation in any other advertisement unless the person apparently responsible satisfies the Panel that the use of the claim or representation would not result in a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.
If the person, apparently responsible for the advertisement, does not comply with a request made under that regulation, the Panel may make a recommendation to the Secretary about the advertisement[2]. The matters that the Panel may recommend are described in s 42ZCAI(4) in these terms:
[2] See s 42ZCAI(3) of the Regulations.
(4)Without limiting subregulation (3), the Panel may recommend that the Secretary do one or more of the following:
(a)if the advertisement is an approved advertisement — withdraw the approval of the advertisement;
(ab)suspend the registration or listing of goods under subsection 29D (1) of the Act;
(b)cancel the registration or listing of the goods under section 30 of the Act;
(ba) order the withdrawal of the advertisement or generic information;
(c)order the publication of a retraction;
(d)order the publication of a correction;
(e)order the recovery of any advertisement or generic information that is still in circulation;
(f)order the destruction of the advertisement or generic information;
(g)suspend a kind of medical device from the Register under Part 4‑6 of the Act;
(h)cancel the entry of a kind of medical device from the Register under Part 4‑6 of the Act;
(i)order that a particular claim or representation made by the advertisement or generic information be withdrawn, and not be used in any other advertisement or generic information unless the person apparently responsible satisfies the Panel that the use of the claim or representation would not result in a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.
The Secretary, having received a recommendation from the Panel, may make orders in the terms set out in s 9 of the Regulations as follows,
(1)On the recommendation of the Complaints Resolution Panel under subregulation 42ZCAI (3) in relation to an advertisement or generic information about therapeutic goods, the Secretary, by written notice, may order a person to do one or more of the following:
(a)withdraw the advertisement or generic information;
(b)publish a retraction;
(c)publish a correction;
(d)recover any advertisement or generic information that is still in circulation;
(e)destroy the advertisement or generic information;
(f)withdraw a particular claim or representation made by the advertisement or generic information, and not use that claim or representation in any other advertisement or generic information unless the person satisfies the Secretary that the use of the claim or representation would not result in a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.
A decision by, or on behalf of, the Secretary pursuant to s 9(1) of the Regulations may be the subject of an internal review pursuant to s 48(2) of the Regulations. A person whose interests are affected by a decision under s 9 of the Regulations may request a reconsideration of the decision (called an “initial decision” in the Regulations) by the Minister. The Minister, or delegate of the Minister, must reconsider the initial decision and (a) confirm the initial decision or (b) revoke it or (c) revoke it and make a decision in substitution for the initial decision. A decision by the Minister, or delegate, pursuant to s 48(3) of the Regulations is capable of being reviewed in the Tribunal[3].
[3]See s 48(5) of the Regulations.
The decision-making process
The advertisements in issue were the subject of a complaint to the Panel in December 2010. The complaint alleged that the advertisements breached s 42DL(1)(c) of the Act and ss 4(1)(b), 4(2)(a), (b) and (c), and 5(2) of the Code. Health World was invited to respond to the complaint but it did so, as it now accepts, inadequately. In the result, on 17 February 2011 the Panel determined that the complaint was substantiated. By letter of 8 March 2011 the Panel requested Health World to withdraw the representation found to have breached the Act or Code and to publish a retraction. Health World did not do so.
In April 2011 the Panel recommended to the Secretary that Health World be ordered to comply with the Panel's determination. More than 12 months later on 27 April 2012 a delegate of the Secretary made orders pursuant to s 9(1) of the Regulations requiring Health World to,
(a)withdraw the advertisement, subject of the complaint, from further publication,
(b)withdraw certain specified representations said to be conveyed by the advertisement,
(c)not use those representations in any other advertisement without satisfying the TGA that the use of them would not result in a contravention of the Act, the Regulations or the Code,
(d)arrange for the publication of a retraction using the form of words drafted by the delegate.
Then, by letter dated 28 June 2012, Health World sought reconsideration of the 27 April 2012 decision. It is necessary to interpolate at this stage that whilst that reconsideration was being undertaken Health World, on 6 August 2012, amended the entry for UTS on the Australian Register of Therapeutic Goods. Those changes amended the standard indications and product specific indications of UTS. Additionally, in July and August 2012 Health World amended its website advertisement to reflect the altered indications shown in the Register. The amendments to the Register and to the advertising reflect the traditional Chinese medicinal use of the ingredients of UTS.
On 28 August 2012 a delegate of the Minister made the decision which is the subject matter of the present proceedings. It is necessary to set out the terms of the decision in full, despite the flaws in it which the Minister concedes. The delegate revoked the decision of 27 April 2012 and replaced it with a decision in these terms:
1. Under Regulation 9(1) I have decided to order Health World Limited to:
(a)withdraw the website advertisement about the product ‘Urinary Tract Support’ found at the Health World Limited website ( from further publication;
(b)withdraw any representations that the advertised product has or may have benefits in relation to, the treatment or prevention of cystitis or urinary tract infections, to relieving symptoms of cystitis or other urinary tract infections, providing anti-bacterial, anti-inflammatory, or anti-microbial effects in the urinary tract or representations/claims to the same effect;
(c)withdraw any representations that the advertised product has or may have benefits in relation to, maintaining a healthy urinary system, detoxifying the urinary system, or words to the same effect, unless these indications/claims are worded to the effect that ‘This (traditional) medicine has been traditionally used for (indication / claim)’;
(d)not use the representations in (a), (b) or (c) above in any other advertisement unless Health World Limited satisfies the Therapeutic Goods Administration (TGA) the use of the representations would not result in a contravention of the Therapeutic Goods Act 1989 (the Act), the Regulations or the Therapeutic Goods Advertising Code 2007 (the Code);
(e) where the representation has been provided to other parties such as retailers or website publishers, and where there is a reasonable likelihood that the representation has been published or is intended to be published by such parties, to advise those parties that the representations should be withdrawn; and
(f) to arrange for the publication on the website of a retraction in the form of, and in accordance with, the conditions set out in Attachment E.
2.Under regulation 9(2) I also impose the following conditions:
(a)within 10 working days of being notified of this order, Health World Limited will provide evidence to me of compliance with this order; and
(b)within 10 working days of being notified of this order, Health World Limited will provide to me a written response indicating that Health World Limited will continue to abide by this order.
The retraction sought was required to appear on Health World's website homepage and to read,
RETRACTION
An advertisement for Ethical Nutrients Urinary Tract Support, which we published on this website, should not have been published.
In the advertisement we unlawfully made claims that the product has or may have benefits in relation to the treatment or prevention of cystitis or urinary tract infections, to relieving symptoms of cystitis or other urinary tract infections, providing anti-bacterial, anti-inflammatory, or anti-microbial effects in the urinary tract, reduce swelling or representations/claims to the same effect.
A complaint about the advertisement was upheld by the Complaint Resolution Panel in March 2011. We provided evidence which was subsequently found to be insufficient to support the claims we made, and the delegate of the Secretary to the Department of Health and Ageing found that the claims were unlawful, misleading, unverified and breached the Therapeutic Goods Advertising Code.
The delegate of the Secretary therefore requested we published this retraction.
The full text of the Panel’s determination can be found at:
>
Whilst it does not appear in the recitation of the terms of the decision it is clear from the delegate's reasons for decision that the decision purports to have effect upon the advertisement that Health World was then using, that is, the advertisement displayed on the website from mid-August 2012. That advertisement was not the subject of the original complaint nor had it been considered at any time in the earlier part of the decision-making process. The parties are agreed that the delegate lacked power to make orders in relation to advertising that had not been the subject of complaint; they differ though as to the consequences of that absence of power. The Minister submits[4] that we ought,
… note that the parties agree that there is no valid determination or reviewable decision with respect to that product or advertisement.
Health World submits[5] that we can, and ought, set aside that part (at least) of the delegate's decision.
[4] Respondent's submissions at [6].
[5] Applicant's supplementary submissions at [28], [33].
The other aspect of the decision conceded to be flawed is that part of the retraction sought that refers to claims that UTS might “reduce swelling”. The delegate accepted, correctly, that Health World made no claims of that nature but did not give effect to that view when determining the terms of the retraction. It is conceded by the Minister that if a retraction is required, it ought not require the retraction of a claim not made.
The advertisement in issue
There were three separate pages. Much of the language is common and much is not contentious. The first[6] reads as follows,
[6] Exhibit 1 (s 37 documents) at T2, page 53.
What is Urinary Tract Infection?
Urinary Tract Infections (UTIs), such as cystitis, are a very common problem in many women. They affect more women than men, and can occur at any age. Most forms of cystitis are caused by bacteria that live in the bowel. They are harmless in the bowel, however when they reach the urethra and head to the bladder they can cause an infection.
Common Symptoms
Women who have urinary tract infections, such as cystitis, may experience symptoms like pain, burning, and an increased frequency of urination. Drinking lots of water and making sure you do urinate frequently rather than trying to hold on while you have an infection may help flush the bacteria from your system.
How can Ethical Nutrients help?
Ethical Nutrients has developed a special herbal combination, Ethical Nutrients Urinary Tract Support. This blend of Traditional Chinese herbs helps to detoxify your urinary system and the broad spectrum antibacterial effects of these herbs assist in the promotion of urinary health, helping to reduce the painful symptoms faster.
Ethical Nutrients Urinary Tract Support may:
·Relieve the pain and burning sensation associated with cystitis.
·Help reduce the frequency of urinary tract infections such as cystitis.
·Have an antimicrobial effect to promote urinary health.
Symptom Relief
Take Ethical Nutrients Urinary Tract Support when you have an acute infection to help relieve the symptoms or if you are prone to infections take this formula daily to help maintain a healthy urinary system.
Ethical Nutrients Professional Natural Medicines are only available from Pharmacies and Health Food Stores, where you can get informed advice about improving your health through diet, lifestyle and quality supplements.
The next advertisement[7] contains, in the main, information regarding dosage, usage and ingredients. Additionally it contains the following statement,
[7] Exhibit 1 at T2, page 54.
Reduces the symptoms of urinary tract infections such as cystitis.
and, in a separate section,
Relieves the pain and burning sensation associated with cystitis.
Promotes urinary tract health.
Has noted antimicrobial action and a detoxifying effect on the urinary system.
May demonstrate broad-spectrum antibacterial and anti-inflammatory activities.
The operative section of the final advertisement[8] reads (as best we can make out),
[8] Exhibit 1 at T2, page 55.
Feel free, with Urinary Tract Support
What is a Urinary Tract Infection?
Urinary Tract Infections (UTIs), such as cystitis, are a very common problem in many women. They affect more women than men, and can occur at any age. Most forms of cystitis are caused by bacteria that live in the bowel. They are harmless in the bowel, however when they reach the urethra and head to the bladder they can cause an infection.
Common symptoms
Women who have urinary tract infections, such as cystitis may experience symptoms like pain, burning and an increased frequency of urination. Drinking lots of water and making sure you do urinate frequently rather than trying to hold on while you have an infection may help flush the bacteria from your system.
How can Ethical Nutrients help?
Ethical Nutrients has developed a special herbal combination, Ethical Nutrients Urinary Tract Support. This blend of Traditional Chinese herbs helps to detoxify your urinary system and the broad-spectrum antibacterial effects of these herbs assist in the promotion of urinary health helping to reduce the painful symptoms faster.
Ethical Nutrients Urinary Tract Support may
·Relieve the pain and burning sensation associated with cystitis.
·Help reduce the frequency of urinary tract infections such as cystitis.
·Have an antimicrobial effect to promote urinary health.
Symptom Relief
Take Ethical Nutrients Urinary Tract Support when you have an acute infection to help relieve the symptoms or if you are prone to infections take this formula daily to help maintain a healthy urinary system.
Ethical Nutrients Professional Natural Medicines are only available from Pharmacies and Health Food Stores, where you can get informed advice about improving your health through diet, lifestyle and quality supplements.
Additionally, the advertisement (or some components of it) contained various warnings about the persistence of symptoms e.g.
Always read the label. Use only as directed. If symptoms persist consult your healthcare professional.
If pain or irritation persists for more than 48 hours, consult your doctor. The presence of blood in the urine warrants immediate medical attention.
The case for the Minister
Given that the Minister contends that the advertisement breached the Act or Code we think it appropriate at the outset to consider the way in which the case for the Minister is put before determining whether it is made good.
First, the Minister asserts that the advertisement contravened s 42DL(1)(c) of the Act, that is, that it contained a restricted representation about UTS which had not been approved under s 42DF(1) of the Act or permitted under s 42DK(1) of the Act. There being no question of approval or permission under those subsections[9] the Minister's case is that the advertisement contained a representation that referred to a form of a disease, condition, ailment or defect identified in a part of the Code as a serious form of a disease, condition, ailment or defect. That is so, it is said, because urinary tract infections and cystitis are urogenital diseases or conditions and are both serious forms of a urogenital disease or condition.
[9] Transcript page 21, lines 18-20.
Next, the Minister contends that the advertisement breached paragraph 5(2) of the Code because it referred to serious forms of diseases, conditions, ailments or defects specified in Part 2 of Appendix 6 to the Code. That questions falls to be decided in the same way as the question concerning s 42DL(1)(c) of the Act.
The Minister's case next relies upon paragraph 4(1)(b) of the Code and the requirement in it that advertisements for therapeutic goods must contain correct and balanced statements only and claims which the sponsor (the importer or manufacturer of the therapeutic goods) has already verified. The Minister’s case is that aspects of the representations conveyed by the advertisement were not correct and balanced by reason of both omissions and positive statements. And, it is said, it contained claims that Health World had not already verified. We explain in greater detail below why this is contended to be so.
It is then said that the advertisement breached paragraph 4(2)(a) of the Code, the prohibition on advertising likely to arouse unwarranted and unrealistic expectations of product effectiveness. Next, the Minister submits that the advertisement breached paragraph 4(2)(b) of the Code, that is, that the advertisement was likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases. Finally, it is contended that the advertisement breached paragraph 4(2)(c) of the Code. It is said that the advertisement was likely to mislead because it contained incorrect representations by virtue of omissions and positive statements.
We should also add that the Minister’s submissions[10] take issue with a submission of Health World[11] that refers to “a reversal of onus”. We accept, as the Minister submits, that there is no question of either party having an onus in these proceedings but also accept that we could not find a breach of the Act or Code without being satisfied that the breach occurred. That being so, we propose to examine the evidence by reference to the breaches of the Act and the Code that the Minister submits we ought to find to determine whether we are so satisfied.
[10] At [156].
[11] Applicant’s submissions at [246].
The Guidelines
Before we consider that evidence and its application to the cases presented, we need to deal first with the Minister's reliance on the Guidelines, that is, the “Guidelines for levels and kinds of evidence to support indications and claims”[12], published by the TGA in April 2011. The Minister accepts that the Guidelines do not have legislative force but says[13],
… they can and should be considered by the Tribunal as indicative of the kind of support that should be available to support claims made in Australia with respect to listed products. They accordingly have a role to play in the fact-finding of the Tribunal, especially as to whether claims are properly supported.
Considerable reliance was placed on the Guidelines in the earlier decision-making. They are given less emphasis in the Minister’s submissions but some reliance on them is maintained. In particular, the Guidelines are used by the Minister in support of the case that the claims made were not “already verified”.
[12] Exhibit 1, supplementary T-documents.
[13] Respondent’s submissions, at [42].
Health World was extremely critical of the use of the Guidelines. It called in aid observations of the Tribunal (constituted by Downes J and Member Schafer) in another case in relation to another set of Guidelines. It contended that these Guidelines were “ambiguous, confusing and inconsistent”. And, it said, the Guidelines have no application to the task of determining whether the advertisement breached the Act or the Code; the purpose was to guide sponsors seeking to list therapeutic goods.
We need not decide whether all of Health World's criticisms are warranted. As it seems to us, it is enough to say that we do not regard the Guidelines as providing any assistance in deciding the questions we have to answer – are urinary tract infections and cystitis urogenital diseases, conditions, ailments or defects, and serious forms of such diseases, conditions, ailments or defects, were the representations not correct and balanced, have the claims been verified, and so on. These questions, we think, must be answered by reference to the evidence before us and, where necessary, having regard to the requirement in paragraph 3(2) of the Code to consider the probable impact of representations on the reasonable person to whom the advertisement was directed.
We do note that the Minister's reliance on the Guidelines in the Statement of Facts, Issues and Contentions produced a flurry of sterile arguments about particulars. That argument could have been avoided if the case for the Minister had been formulated, as it ultimately was in submissions, by reference to the statutory setting, not a set of Guidelines that serve an entirely different purpose.
The witnesses
In considering the factual questions that arise for consideration we had the benefit of evidence from a number of medical witnesses. Dr Kerryn Phelps, called by Health World, is an experienced general practitioner who has been in continuous general practice since 1984. She is, and has been since 2003, a consultant to Health World and receives a commission on sales of UTS. Dr Henry Liang, also called by Health World, has undergraduate and master’s degrees in Chinese Medicine from Guangzhou University, China and a doctorate from RMIT University, Melbourne for a research project dealing with Chinese medicine for lung cancer. He is an experienced Chinese medicine practitioner. Associate Professor Luis Vitetta is the Director of the Centre for Integrative Clinical and Molecular Medicine, at the University of Queensland School of Medicine. He has over 25 years’ experience with epidemiology and medical research. He has considerable experience with Chinese herbal medicine and a particular interest in the investigation of the efficacy and safety of natural compounds.
The Minister called two specialist medical practitioners, Dr Allen Cheng and Dr Alastair Gillies. Dr Cheng is a physician specialising in infectious diseases and has an appointment as Associate Professor of Infectious Diseases Epidemiology at Monash University. Dr Gillies has been a consultant nephrologist since 1978. He is the Conjoint Associate Professor in the School of Medicine and Public Health at the University of Newcastle.
There is, by and large, no great difference between the various witnesses. We observe however that we propose to prefer the evidence of Dr Cheng and Dr Gillies to that of Dr Phelps. They are specialist practitioners, Dr Phelps is a general practitioner, albeit one with considerable experience. Moreover Dr Phelps has a plain conflict of duty and interest. As it seems to us, it would have been preferable if Health World could have relied on a witness without that conflict.
Was s 42DL(1)(c) of the Act breached?
At the outset we need to make reference to a construction argument raised by Mr Derrington SC who appeared for Health World with Mr Chesterman of counsel. The argument focused upon the apparent disharmony between s 42DD of the Act, and its reference to the identification in the Code “as a serious form of a disease, condition, ailment or defect”, and the manner of that identification in the Code. It is said[14] that, in order for a representation to be a restricted representation, it is necessary that Part 2 of Appendix 6 of the Code identify a condition as a serious form of the disease, condition, ailment or defect. Table 1 of Appendix 6, it is submitted, does not do that. Rather, it lists the various diseases, conditions, ailments and defects and provides a definition, in general terms, of “serious”. But that, it is contended, is not sufficient to meet the definition in s 42DD of the Act. Absent identification in the Code of a serious form of the disease, condition, ailment or defect, the section, so it is said, has no operative effect.
[14]Applicant's submissions, paragraph [97].
The argument is interesting however we have found it unnecessary to reach a concluded view on it. Whilst the language is certainly not ideal we are prepared to assume, rather than decide, that Appendix 6 of the Code was intended to complement s 42DD of the Act because, even if that assumption be made, the evidence, discussed below, does not satisfy us that the advertisement contained a restricted representation about therapeutic goods.
We also observe, by way of a preliminary comment, that whilst the advertisement uses the expression “urinary tract infections” (or its abbreviated form) it is generally followed by the phrase “such as cystitis”. We consider that, on a fair reading of the advertisement, it is to be regarded as an advertisement concerning cystitis, a category of urinary tract infection, not as an advertisement concerning cystitis and other unspecified and unnamed types of urinary tract infections or an advertisement about urinary tract infections generally. It is true, as the Minister’s submissions point out[15], that it contains several references where references to infection is not linked to cystitis however the repeated references to “urinary tract infections, such as cystitis” lead us to conclude that the advertisement is about cystitis, a specie of urinary tract infection. We therefore do not regard it as necessary to consider the advertisement as anything other than an advertisement concerning cystitis. Thus, we consider it necessary to consider two questions, (a), is cystitis a urogenital disease, and, (b), if it is, is it a serious form of urogenital disease.
[15] Respondent’s submissions, paragraph [73].
Health World submits that a urogenital disease or condition is one that relates to or involves both the urinary and genital structures and functions. Dr Cheng and Dr Gillies gave evidence on the issue as did Dr Vitetta.
Dr Cheng, in his report, said,
A urinary tract infection (UTI) by definition involves the urogenital tract.
Subsequently, he referred to infection in the bladder which, “forms part of the urogenital tract”. Dr Gillies’ evidence was more equivocal. In his report he noted that,
If the concept of urogenital tract is fully inclusive then obviously urinary tract infection and cystitis would be included.
In his oral evidence[16] he agreed to the proposition that a fair definition of urogenital disease is that it is a disease that relates to or involves both the urinary and genital structures or functions. Dr Vitetta is not a medical practitioner but has considerable experience in medical matters. He regarded both cystitis and urinary tract infection as urogenital diseases.
[16] Transcript page 166, lines 40 – 42.
It seems to us on balance that we should conclude that cystitis is a urogenital disease or condition and, were it necessary to consider the matter separately, so too is urinary tract infection.
The question then arises whether cystitis is a serious form of urogenital disease, that is, is it a form of urogenital disease or condition which is,
· Generally accepted not to be appropriate to be diagnosed and/or treated without consulting a suitably qualified healthcare professional, and/or
·Generally accepted to be beyond the ability of the average consumer to evaluate accurately and to treat safely without regular supervision by a qualified healthcare professional.
The evidence is that urinary tract infection and cystitis are very common and that there is a high rate of recurrence[17]. Thus the reasonable person to whom the advertisement was directed must be regarded as a person who had previously suffered from the symptoms of cystitis rather than as a person suffering from the symptoms for the very first time. That is, we do not regard the advertisement has been directed to the first-time sufferer, that person undoubtedly would be consulting a medical practitioner. And there is a distinction to be drawn between complicated and uncomplicated conditions. Dr Gillies said this,
Clinical assessment of urinary tract infection hinges on the distinction between infection occurring in patients with anatomical, functional or metabolic problems that increase the risk of severe disease or treatment failure collectively described as complicated urinary tract infection and those without such problems, described as uncomplicated urinary tract infection.
[17] Exhibit 13, page 2.
The evidence on the first limb of the definition, appropriateness of self-diagnosis, is quite clear. Dr Cheng was asked to report on the question,
Is it appropriate for a person to self-diagnose and/or treat a urinary tract infection or cystitis without consulting a suitably qualified healthcare professional?
Dr Cheng's answer was unequivocal. He said[18],
Generally, it is appropriate for patients to self-diagnose and treat. Studies where an inactive or no active treatment are administered show that clinical cure occurs in 25 – 42% of patients…, and that the risk of progression to more serious infection is uncommon… However, these studies suggest that the duration of symptoms (and bacteriological cure) is shortened by the use of antibiotics when compared to no treatment…. Self-diagnosis and treatment is often appropriate and safe in otherwise healthy women with frequent recurrent urinary tract infections… [Citations omitted]
[18] Exhibit 12, page 2.
And Dr Gillies said[19],
An acute uncomplicated episode of cystitis rarely progresses to severe disease, even if untreated. The goal of treatment therefore is to ameliorate symptoms. There is evidence that early treatment shortens the duration of symptoms. In the case of patients with recurrent urinary tract infection self-diagnosis and self-treatment of individual episodes is appropriate but should occur within the context of a management plan agreed between the patient and their Medical Practitioner who should regularly assess the possibility of complicating problems and the consequences of frequent use of antibiotics or other treatment. A self-management plan should include arrangement for urine culture prior to the commencement of treatment.
In his oral evidence[20] Dr Gillies expressed the opinion that it was not necessary for patients familiar with the symptoms to seek medical attention and that some form of symptomatic relief would be appropriate in such circumstances.
[19] Exhibit 13, pages 2-3.
[20] See his evidence generally at transcript page 167, line 35 to page 169, line 14.
It is to be remembered that consumers are advised to consult their healthcare professional if symptoms persist and to consult a medical practitioner if they persist for more than 48 hours. The evidence does not satisfy us that it is generally accepted that urinary tract infections such as cystitis are not appropriate to be diagnosed and/or treated without consulting a suitably qualified healthcare professional. The first limb of the definition of serious is not made out. We would add only that in reaching that conclusion we do not accept the submission for Health World that it is necessary for it to be demonstrated that it is not ever appropriate for cystitis to be diagnosed and treated without consulting a healthcare professional. The general acceptance of medical practitioners, which we think is the issue, is demonstrated by the evidence of Dr Cheng and Dr Gillies.
The next question is whether the second limb of the definition is made out, that is, whether cystitis is generally accepted to be beyond the ability of the average consumer to evaluate accurately and to treat safely without regular supervision by a healthcare professional.
It is apparent from the material that neither Dr Cheng nor Dr Gillies was asked by the solicitors for the Minister to consider that question when they were retained to provide reports. Both doctors were asked to consider that question in their evidence in chief. Health World’s submissions hinted at a conspiracy to change the nature of the Minister’s case[21]. Not to be outdone the Minister’s submissions hinted at omissions by oversight[22], a submission that ought to have been given an evidentiary foundation if it were to be relied upon. We propose not to concern ourselves with the reason that neither doctor was asked to comment on the question but to proceed on the footing that they were first asked to consider the issue in the course of the evidence in chief.
[21] Applicant’s submissions paragraph [114]; transcript page 151, line 13.
[22] Respondent's submissions paragraph [84] and [85].
It must be said that in one passage of his evidence[23] Dr Cheng, by reference to the second limb of the definition, appeared to accept that cystitis satisfied that limb but, with respect, we do not agree. There is only one relevant difference of substance between the two limbs of the definition of serious. The first limb speaks of the appropriateness of self-diagnosis and treatment, the second speaks of the ability of the average consumer to do so. It seems to us to be inconceivable that it could be generally appropriate for patients to self-diagnose and treat yet beyond their ability to evaluate accurately (which cannot mean other than self-diagnose), and to treat the condition.
[23] Transcript page 150, lines 20 – 30.
In light of the evidence about the appropriateness of self-diagnosis, and particularly that of Dr Cheng set out above, we are left in the position that we conclude that we are not satisfied that cystitis satisfies the second limb of the definition of serious.
It follows that we are not satisfied that the advertisement breached s 42DL(1)(c) of the Act. We stress that we ought not be taken to be concluding that cystitis is not a serious disease or condition, only that the evidence before us leaves us not satisfied that it is a serious form of urogenital disease or condition.
We deal finally, and necessarily briefly, with a submission of Health World[24] that the fact of earlier approval by delegates of the Secretary of print advertisements in relevantly identical terms was, in some way, supportive of the conclusion that cystitis was not a serious form of urogenital disease or condition. We are obliged to reach our conclusions on the basis of the evidence before us. We are not aware of the material that was before other decision-makers at an earlier point in time. The determinations of those decision-makers on unknown material are not of any assistance to us.
[24] Applicant’s submissions, paragraph [126] and [127]
Paragraph 5(2) of the Code
A conclusion that paragraph 5(2) of the Code was breached requires us to be satisfied that the advertisement referred to a serious form of urogenital disease or condition. For the reasons already expressed we are not so satisfied.
Paragraph 4(1)(b) of the Code
This paragraph of the Code requires an advertisement for therapeutic goods to,
… contain correct and balanced statements only and claims which the sponsor has already verified.
The Minister identifies a number of ways in which it is said that the advertisement was “less than correct and balanced”. We will deal with them in the order in which they are articulated in the Minister’s submissions and by reference to the paragraph numbers in those submissions.
First, it is said[25] that the advertisement does not say that the claims are reliant upon traditional Chinese medicine, that it does not use the form of words “traditionally used for…” in connection with the claim and that the advertisement is absent a statement that the claims made lack Western scientific medical support, beyond, as the Minister accepts, the description of UTS as a “blend of traditional Chinese herbs”.
[25] Respondent’s submissions, paragraph [106].
Next, in paragraph 107 of the submissions, the Minister refers to, without really identifying,
… statements, express or implied, which, on the medical evidence before the Tribunal, are likely not to be correct.
Reference is then made to the totality of the evidence of Dr Gillies and Dr Cheng but no attempt is made to identify any particular evidence of theirs or claims likely not to be correct. The exception is a reference to evidence of Dr Phelps that she would not recommend UTS for the treatment of confirmed bacterial urinary tract infections. It is not clear to us what claims that evidence is said to falsify. We do not propose to consider this submission further.
In paragraphs 108 and 109 of the Minister's submissions five “express or implied representations” are identified which, it is said, are not correct and balanced. The representations are,
(a)that UTS has or may have benefits in relation to the treatment or prevention of cystitis or urinary tract infections;
(b)that UTS has or may have benefits in relation to relieving symptoms of cystitis or other urinary tract infections;
(c)that UTS has or may have benefits in relation to providing antibacterial, anti-inflammatory or antimicrobial effects in the urinary tract;
(d)that UTS has or may have benefits in relation to maintaining a healthy urinary system without prefacing the claim with words indicating that “this (traditional) medicine has been traditionally used for” that purpose; and,
(e)that UTS has or may have benefits in relation to detoxifying the urinary system without prefacing the claim with words indicating that “this (traditional) medicine has been traditionally used for” that purpose.
The Minister submits[26], and we accept, that we need to consider the advertisement as a whole and form our own view of the representations conveyed by it. Although we agree with that approach, the minute analysis of the advertisement which the Minister undertakes in the written submissions adopts, with respect, a contrary approach. Additionally, it needs to be borne in mind that the subject matter of this discussion is an advertisement. The reasonable person to whom the advertisement is directed expects that it will detail the benefits of the product; the reader would not expect the product’s shortcomings to be catalogued in the advertisement. Thus it may be accepted, as we discuss below, that reference to traditional Chinese use would provide balance, however we do not see that balance requires a disclaimer about the lack of Western scientific medical support for the claims.
[26]Respondent's submissions, paragraph [50]. See also Applicant's submissions, [155].
It is the case, as Dr Vitetta in particular explained, that the claims made lack support in Western scientific medical literature but that there is support for the claims in traditional Chinese medicine. Thus, in our view, the advertisement, absent the qualification regarding traditional Chinese use was not balanced. That was its vice. The reference to a “blend of Traditional Chinese herbs” provides a hint that a discerning reader might interpret as indicating that UTS was a traditional Chinese medicine remedy and that the claims made were supported by the science of that discipline, however that was not sufficient for the reasonable reader to whom the advertisement was directed. And, necessarily, the absence of that qualification meant that the advertisement was not correct.
That conclusion is sufficient to dispose of the Minister's complaints, set out in paragraph 56 above, about express or implied representations. Those claims are not correct and balanced but that is because the advertisement lacked the reference to traditional Chinese medicine not from any inherent vice in the claims themselves. That is so because, as the survey of the material undertaken by Dr Vitetta demonstrates, subject to some minor qualifications, the claims are supported by traditional Chinese medicine.
In the result we are satisfied that the advertisement did not contain correct and balanced statements and that that was so because it did not contain a reference to the traditional Chinese medicine use of UTS.
The Minister's complaint that the claims made i.e. the five express or implied representations, had not been already verified by Health World, was predicated on the absence of Western scientific medicine support for the various claims, what the Minister’s submissions, in reliance on the Guidelines, describe as “high level evidence”. As we have said, we do not propose to use the Guidelines to determine whether the Code has been breached in this, or other, respects. It is a Guideline designed to inform the sponsors of the TGA's policy position on the evidence required to support claims made when listing therapeutic goods. It is of no assistance to us.
That said, it seems clear that the claims made lack support in Western scientific medicine. The difficulty we have with this aspect of the case is that the Minister did not articulate the case in the way it is now put in final submissions. The Minister's case, as articulated in the Statement of Facts, Issues and Contentions lodged on 25 January 2013[27] was put on the basis that the claims lacked the support required by the Guidelines. Nonetheless Health World did not seek to reopen the hearing nor call further evidence once it became clear how the Minister's case was being put. We think that the Statement of Facts, Issues and Contentions, particularly in paragraph 101 and 102, was sufficient to put Health World on notice that ultimately the standard that the Minister would invite us to consider was that of Western scientific medicine.
[27] Exhibit 17.
By that standard, the claims made lack support but they did not lack support in traditional Chinese medicine. Thus, again in our view, the vice in the advertisement was the absence of a clear reference to the traditional Chinese medicine origins of UTS and the supporting traditional Chinese medicine for the claims made. And, as we understand the evidence of Dr Vitetta, the material relied upon by Health World to verify the claims supported the making of those claims with the exception of a claim that UTS might relieve the pain and burning associated with cystitis.
The Minister submits[28] that “the Australian consumer” would expect that claims made would comply with Western scientific methodologies and that the Tribunal “should consider the same to be correct and preferable”. If, by that submission, it is intended to suggest that any claim made must be supported by evidence from that source, we do not agree. We would think it highly unlikely that the Australian consumer would regard it as appropriate that a product, plainly and unambiguously based on traditional Chinese medicine use, would expect that there be Western scientific medicine support for the claims; the consumer would expect support in traditional Chinese medicine. Thus the verification required in order to comply with the second limb of paragraph 4(1)(b) of the Code will vary according to the nature of the product and the context of the claims made.
[28] Respondent’s submissions, paragraph [123].
Here, the advertisement did not unambiguously assert reliance on traditional Chinese medicine use. Thus, in our view, the claims made had not already been verified and paragraph 4(1)(b) was breached in that respect.
Paragraph 4(2)(a) of the Code
The next aspect of the case is the Minister's contention that the advertisement breached paragraph 4(2)(a) of the Code, the requirement that an advertisement not “be likely to arouse unwarranted and unrealistic expectations of product effectiveness”.
The Minister's first submission[29] is that the “ordinary and reasonable consumer”[30] would expect that the Code and the Act would be complied with. Thus, it is submitted, other breaches of the Code demonstrate a breach of paragraph 4(2)(a) of the Code. We reject that submission.
[29] Respondent's submissions, paragraph [136].
[30]We note that the test is that of the reasonable person to whom the advertisement is directed.
The Minister’s case is that the advertisement was likely to arouse unwarranted and unrealistic expectations. That seems to us to mean that we must be satisfied not only that the reasonable person to whom the advertisement is directed would expect that the claims made were likely to be made good (a proposition we are prepared to assume) but also that those expectations were unwarranted and unrealistic. That latter proposition might have been demonstrated by evidence from users of UTS sufficient to demonstrate that UTS was not effective and could not make good its claims. In that case the demonstration of sufficient unsatisfied expectations might permit an inference to be drawn that the reasonable reader's expectations must be unwarranted and unrealistic. Alternatively, it might have been demonstrated by evidence that the claims could not have been made good as a matter of science or medicine.
But the Minister has not sought to demonstrate the creation of unwarranted and unrealistic expectations in either of these ways. Instead, and at the highest for the case for the Minister, the evidence of Dr Cheng that is relied upon[31] demonstrates no more than that the claims were not supported by the studies submitted. The same is true of the evidence of Dr Gillies relied upon by the Minister[32] as to the absence of acceptable scientific evidence. In short, there is no evidence from which we could be satisfied that any expectations aroused should be regarded as unwarranted or unrealistic. To the contrary there is evidence, analysed by Dr Vitetta, that the claims made, and the expectations aroused, were, from the perspective of traditional Chinese medicine, warranted and realistic. The single exception identified by Dr Vitetta does not falsify that proposition
[31] Respondent's submissions, paragraph [139].
[32] Respondent's submissions, paragraph [140].
We are not satisfied that the advertisement breached paragraph 4(2)(a) of the Code.
Paragraph 4(2)(b) of the Code
This paragraph of the Code requires that an advertisement not be likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases.
The Minister submits that “serious” in this paragraph of the Code ought be given the same meaning as “serious” in Table 1 of Appendix 6. We do not see why that should be so. In paragraph 4(2)(b) it is used in the context of a diagnosis or treatment of “potentially serious diseases”. The language of the Appendix is quite different; the reference is to serious forms of specified diseases, conditions, ailments and defects. The drafter of the Code was not unfamiliar with the notion of adopting by cross-reference as paragraph 4(2)(j) demonstrates. Had it been designed to incorporate the Appendix 6 definition of serious it would have been a simple task for the drafter to have done so.
We do not accept the argument. We consider that the expression “potentially serious diseases” ought be given its ordinary meaning.
But, in any event, we do not otherwise accept the Minister's argument under this head for two reasons.
First, the reasonable reader of the advertisement must be assumed to read the label, a fortiori where the reader is explicitly told to do so. Thus the reasonable reader would be expressly advised to consult a healthcare professional if symptoms persist and to consult a medical practitioner if pain or irritation persists for more than 48 hours.
But more importantly, we accept, as Health World submits, that there is nothing in the advertisement that would lead to consumers self-diagnosing or inappropriately treating any disease, potentially serious or otherwise. The advertisement does not suggest that a particular range of symptoms should be considered to be a particular disease. It does no more than suggest that those symptoms may be alleviated by UTS. As the submissions of Health World suggest, this paragraph of the Code is concerned with advertisements which are likely to cause consumers to seek to cure or treat potentially serious diseases by themselves without seeking medical assistance. The advertisement suggests that UTS may provide symptomatic relief in assisting or helping in relation to urinary tract health; it does not suggest diagnosis or cure. And, as we have already noted, explicit warnings are given to consumers in relation to the seeking of further advice after a relatively short period of time.
Thus we do not accept that the advertisement breached paragraph 4(2)(b) of the Code.
Paragraph 4(2)(c) of the Code
Paragraph 4(2)(c) of the Code requires us to consider whether the advertisement was misleading, or likely to mislead. It requires consideration of what is implied as well as that which is expressed. Moreover, explicitly, omissions must be taken into account. In advance of the hearing the solicitors for Health World sought particulars of the way in which the Minister's case was to be put. They were not provided nor were they provided in the Minister's final submissions. Rather, the case for the Minister was put in this way,
The representations relied upon are those identified as 1 to 5 above under the heading “Breach of paragraph 4(1)(b) of the Code”. They convey what is there alleged. They are misleading for the same reasons as they are likely to be incorrect. They are likely to be incorrect for the same reasons, based on the same evidence, as they have already been submitted to be not correct and balanced. All of the submissions made under the heading “Breach of paragraph 4(1)(b) of the Code” are accordingly repeated – and the same evidence is relied upon. Lack of verification is also misleading, because the ordinary or reasonable consumer would expect compliance with the Code and that includes that the Applicant only make in its Advertisement claims that are “correct and balanced”, which it had already verified. The omissions noted towards the outset of the above submissions upon “Breach of paragraph 4(1)(b) of the Code” are also particularly important as to how the Advertisement is misleading. Those omissions are themselves misleading.
We do not agree.
We have already dealt with much of the Minister's case under this head by reference to the earlier contentions. As we have said, we regard the vice in the advertisement to be the omission of the recognition of traditional Chinese medicine use for UTS. That absence, in our view, made the advertisement not correct and balanced. But it does not make it misleading. Moreover, we have rejected the notion that the reasonable reader of the advertisement would expect the advertisement to comply with the Code. We do so again.
The advertisement makes reference to it being a “blend of Traditional Chinese herbs”. We would not consider the reasonable reader to whom the advertisement was directed to consider other than that UTS was a traditional Chinese medicine remedy. Similarly, we do not consider that the reasonable reader would be misled or is likely to be misled, because, as we have found, the claims made in the advertisement had not been verified by the standards of Western scientific medicine. We need not repeat our earlier conclusions. In circumstances where the Minister advances this aspect of the case by reference to the earlier allegations no further analysis by us seems warranted. We are not satisfied that paragraph 4(2)(c) of the Code was breached.
In the result we conclude that the advertisement did breach the Code in two respects, it was not correct and balanced and the claims made had not already been verified, however as we have sought to demonstrate those breaches arise from the omission of express reference to UTS being a traditional Chinese medicine remedy.
What decision is warranted?
By virtue of s 48(3) of the Regulations, the Minister (or delegate) had the power to confirm the initial decision, to revoke the initial decision, or to revoke the decision and make a decision in substitution for it. We have reached the conclusion that the advertisement breached the Code (but not the Act) and not to the extent found by the original decision maker. That being so, there is no question of affirming the decision under review because the effect of that would be to confirm the original decision. Necessarily we would set aside the decision under review however we need to then decide what decision ought be made in substitution for it. That decision must be one that conforms with the power in s 48(3) of the Regulations, that is, it must be a decision to revoke or a decision to revoke and substitute.
Given the conclusions we have reached about the breaches of the Code it would ordinarily be the case that an order for the withdrawal of the advertisement would be warranted. However in the somewhat unusual circumstances of this case we do not regard that as being necessary, despite our conclusions about the breaches of the Code. That is so because Health World has already withdrawn the advertisement (and labelling) and did so voluntarily. And, according to its Managing Director, Mr Alan Gee, it does not intend to use the form of words used in the original advertisement. Rather it will, in the future, use the statements used in advertisements from August 2012 onward that refer to the claims as being supported by traditional Chinese medicine. It is the case that, despite the evidence of Mr Gee that the advertisement had been withdrawn, there remained on the website of Health World after July 2012 an advertisement using the form of words subject to the original complaint. Mr Gee said that this had occurred through oversight and that Health World had intended to withdraw the totality of the advertisement. We accept Mr Gee's evidence that that was the intention of Health World and his evidence generally. In particular, we accept that the advertisement remained on the website through oversight not intention.
It is the case that all versions of the advertisement subject of the complaint have now been withdrawn and that Health World does not intend to advertise in those terms again. In those circumstances no purpose would be served in ordering a withdrawal.
The other aspect that needs consideration is the question of a retraction. We start by observing that we reject the Minister's submission[33] that Health World “is an applicant that needs compulsion”. Much of the submission is based upon parts of the reviewable decision that we do not accept. Moreover, the submission evidences a degree of scepticism about the genuineness of Health World's attempts to remove all traces of the advertisement from its website. We do not share that scepticism.
[33] Respondent's submissions, paragraph [161].
For a variety of reasons we have concluded that the publication of a retraction is not warranted. We acknowledge, in reaching that conclusion, the protection of the public is the objective of the statutory scheme and that that objective ought not be subjected to the economic interests of Health World. But we reach that conclusion without regard to Health World's economic interests.
First, it is the case that there is no evidence that purchasers of UTS or consumers more generally have been prejudiced, either medically or economically, by the advertisement. Such evidence is not necessary but evidence of significant consumer complaints would be a powerful reason to require a retraction. The absence of evidence of such complaints tends to tell against the requirement of a retraction.
Next, it is the case that for many years advertisements in identical form or at least substantially similar form were broadcast on television or published in newspapers and magazines with the express approval of delegates of the Secretary, Department of Health and Ageing. It seems, with respect, absurd to require a retraction of claims made in Internet advertising where no similar retraction is required of television and print advertising.
Additionally, most forms of the advertisement were withdrawn in July 2012 and there has not been any great publication of the advertisement since that time.
Finally, these reasons, publicly available on the Internet, will record our views about the fact and extent of breaches by Health World of the Code.
In circumstances where we do not regard either a withdrawal of the advertisement or particular claims as necessary and do not consider a retraction necessary the appropriate decision, having regard to s 48(3) of the Regulations, is to simply revoke the initial decision of 27 April 2012.
In light of that conclusion we need not decide the controversy between the parties adverted to in paragraph 19 above.
I certify that the preceding 93 (ninety-three) paragraphs are a true copy of the reasons for the decision herein of Deputy President PE Hack SC, Senior Member RG Kenny and Dr GJ Maynard (Member) ......................................................................
Associate
Dated 7 June 2013
Date(s) of hearing 11, 12 & 13 February 2013 Date final submissions received 11 March 2013 Counsel for the Applicant Mr RM Derrington SC & Mr DEF Chesterman Solicitors for the Applicant HWL Ebsworth Counsel for the Respondent Mr GT Johnson SC Solicitors for the Respondent Sparke Helmore
Key Legal Topics
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Administrative Law
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Judicial Review
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Administrative Decision Making
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Retraction
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