Australian Competition and Consumer Commission v Homeopathy Plus! Australia Pty Limited - [2014] FCA 1412 - FCA 2014 case summary — Zoe

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Australian Competition and Consumer Commission v Homeopathy Plus! Australia Pty Limited

[2014] FCA 1412

Federal Court of Australia|2014-12-22|Before: Perry J

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Court

Federal Court of Australia

Decision date

2014-12-22

Before

Perry J

Source

Original judgment source is linked above.

Judgment (30 paragraphs)

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introduction 1 The first respondent, Homeopathy Plus! Australia Pty Ltd ("Homeopathy Plus"), is an Australian proprietary company limited by shares which was registered in New South Wales on 20 November 2008. It is not in dispute that, among other activities, Homeopathy Plus sells homeopathic products and treatments through its website at www.homeopathyplus.com.au ("the Website"). 2 The second respondent, Mrs Frances Sheffield, has been the sole director of the first respondent since 18 November 2009. It is common ground that she is the author of three articles which she uploaded onto the Website, namely: (a) "Whooping Cough - Homeopathic Prevention and Treatment" ("First Whooping Cough Article"); (b) "Whooping Cough - Homeopathic Prevention and Treatment" ("Second Whooping Cough Article"); and (c) "Government Data Shows Whooping Cough Vaccine a Failure" ("Government Article") (collectively referred to as the "Three Articles"). 3 The domain name of the Website is registered to Mrs Sheffield and her husband. 4 The applicant ("the ACCC") seeks declarations, injunctions, penalties and ancillary orders in respect of alleged contraventions by the Respondents of the Australian Consumer Law ("ACL"), being Schedule 2 to the Competition and Consumer Act 2010 (Cth) ("CCA"). The CCA and ACL came into force on 1 January 2011. The contraventions are said to arise from statements made in the Three Articles published on the Website. 5 This judgment addresses only the question of whether the alleged contraventions have taken place. As foreshadowed before the trial and confirmed at the hearing with the parties, the hearing covered all matters relating to the alleged contraventions of the ACL, the circumstances in which they occurred and the severity of those contraventions. The issues addressed by these reasons are similarly confined. That approach leaves open the option to the parties for evidence to be led otherwise in mitigation of penalty and the like, and for separate submissions to be made as to the pecuniary penalty, injunctive relief and other final orders sought by the ACCC aside from the declaratory relief sought which I will grant for the reasons I explain in the conclusion. 6 The dispute centres upon the proper characterisation of the representations made in the Three Articles and whether those representations were made in trade and commerce. The ACCC alleges that the Three Articles contained false, misleading and/or deceptive representations contrary to ss 18 and 29(1)(a), (b) and (g) of the ACL concerning: (a) the effectiveness of the Vaccine publicly available in Australia for the prevention of whooping cough; and (b) the safety and effectiveness of homeopathic treatments as an alternative to the Vaccine for the prevention of whooping cough. 7 No allegations are made with respect to any statements as to the effectiveness of homeopathic treatments for the treatment, as opposed to prevention, of whooping cough, or as a complementary treatment more broadly, or in respect of any vaccine other than that for Whooping Cough ("the Vaccine"). 8 Section 18 of the ACL provides that: A person must not, in trade or commerce, engage in conduct that is misleading or deceptive or is likely to mislead or deceive. 9 Section 29 has more specific elements and relevantly provides that: (1) A person must not, in trade or commerce, in connection with the supply or possible supply of goods or services in connection with the promotion by any means of the supply or use of goods or services: (a) make a false or misleading representation that goods are of a particular standard, quality, value, grade, composition, style or model or have had a particular history or particular previous use; or (b) make a false or misleading representation that services are of a particular standard, quality, value or grade; or … (g) make a false or misleading representation that goods or services have sponsorship, approval, performance characteristics, accessories, uses or benefits;… 10 The ACCC alleges that Homeopathy Plus and Mrs Sheffield engaged in the impugned conduct as principal contraveners. For the reasons I set out below, I find the contraventions of the ACL alleged by the ACCC to be established.

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2.1 The ACCC's primary contentions 11 The ACCC alleges that Homeopathy Plus and/or Mrs Sheffield, made representations to the effect that the Vaccine: (a) is short-lived, unreliable and no longer effective in protecting against whooping cough ("the First Vaccine Representation"); (b) may not be the best solution for, is of limited effect and is unreliable at best, in protecting against whooping cough ("the Second Vaccine Representation"); and (c) is largely ineffective in protecting against whooping cough ("the Third Vaccine Representation"); (together the "Vaccine Representations"). 12 The ACCC contends that the Vaccine Representations are false, misleading and/or deceptive in contravention of ss 18 and 29(1)(a) and (b) of the ACL because the Vaccine is, in fact, effective in protecting a significant majority of people who are exposed to whooping cough infection from contracting whooping cough. 13 The ACCC further alleges that, by publishing, or causing to be published, the First and Second Whooping Cough Articles and the Government Article in conjunction with the Second Whooping Cough Article, the Respondents made representations to the effect that there was a reasonable basis, in the sense of an adequate foundation in medical science, to enable it or them, as the case may be, to state that homeopathic treatments are a safe and effective alternative to the Vaccine for the prevention of whooping cough (the "Homeopathy Alternative Reasonable Basis Representation"). This representation is also alleged to be false, misleading and/or deceptive in contravention of ss 18 and 29(1)(a), (b) and (g) of the ACL on the grounds that: (a) there is no reasonable basis in medical science to allow the Respondents to state that homeopathic treatments are safe and effective as an alternative to the Vaccine for the prevention of whooping cough; and (b) the Vaccine is the only treatment currently approved for use and accepted by medical practitioners in Australia for the prevention of whooping cough. 14 In determining these claims, it was not in issue that the Court should construe the Three Articles, including the key notions said to be conveyed by them, in the plain English sense in which the public would understand them. In this regard, the ACCC submitted (and I do not understand it to be in issue) that, based upon the Oxford English Dictionary and Macquarie Dictionary (5th edition) definitions, the meaning of these key notions were as follows: "Unreliable" means not able to be relied upon. "Reliable" in turn means consistently good in quality or performance, able to be trusted. "Ineffective" means not producing any or the desired effect. "Solution" means the act of solving a problem, or state of being solved; a particular instance or method of solving. "Short-lived" means lasting only a short time; or living or lasting only a little while. 15 In support of its contentions that each of the representations were false, misleading or deceptive, the ACCC relied upon the expert evidence of three witnesses: a) Dr Nicholas Wood, Staff Specialist, General Medicine at the Children's Hospital at Westmead and a Senior Research Fellow at the National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases; b) Dr Nigel William Crawford, Medical Head of Immunisation Services (which recommends and administers vaccines to high-risk children, including whooping cough, according to the schedule) and a Paediatrician at the Royal Children's Hospital in Melbourne; andProfessor Kerryn Phelps AM, General Practitioner, who was the President of the Australian Medical Association from 2000-2003, and the President of the Australasian Integrative Medicine Association from 2009-2012. 16 Ultimately, no expert evidence was relied upon by the Respondents that materially contradicted the evidence of these witnesses; the evidence of Dr Mark Donohoe called by the Respondents being consistent with that of the experts called by the ACCC. Nor was the expertise of Dr Wood, Dr Crawford and Professor Phelps to give evidence on the matters addressed by them in their reports in issue.

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2.2 Respondents' defence 17 In their defence, the Respondents contend that: (a) the statements in the Three Articles were not made in trade and commerce but "were uploaded for general information and education purposes and were a contribution to an ongoing public debate of scientific and political interest which is an activity regularly undertaken by [Homeopathy Plus]"; (b) the statements in the Three Articles were not false, misleading and deceptive as there is a reasonable basis in homeopathic science for the statements as to the effectiveness of homeopathy in the prevention of whooping cough; and/or (c) the statements in the Three Articles were not false, misleading and deceptive even if measured against orthodox medical science. 18 The Respondents summarised the primary elements of their defence in their submissions in closing as follows: I. When corporations conceived with an advocacy purpose participate in public debates about science and politics it does not necessarily follow that their conduct is commercial simply because they are corporations. The intention of the alleged contravener is important to assess during the trade and commerce test (i.e. the design of the representations). The representations were not centrally conceived or designed with a trading or commercial purpose and did not amount to conduct in trade or commerce. When qualified assertions, which are accurate summations of a position within a wider debate, are made not about 'products' but rather the roll-out of a complicated Government schedule and its effectiveness then those assertions bear a non-commercial character. II. Those same qualified assertions, even if they were sufficiently commercial in character so as to attract the jurisdiction of the ACL, are factually well-founded insofar as they relate to the vaccines. This is based on a plain reading of the words themselves rather than an unnecessarily medico-technical one based on the insertion of concepts of efficacy foreign to the readers of the website. III. The commentary on homeoprophylaxis has been shown to fall within the accepted definitions of that modality and cannot be considered misleading when read in their context as emanating from a homeopathy publication (the name Homeopathy Plus! across all banners and weblinks relevant to this proceeding is not merely suggestive, but overt, with regard to the framework within which the statements are made). There is a clear differentiation between the two epistemological frameworks and Homeopathy Plus! never passed off 'mainstream acceptance' as per the allegations of the Applicant. (emphasis in original) 19 Preliminary issues arose as to the bulk of the expert evidence which the Respondents sought to lead in support of the second and third primary grounds of their defence. These are considered below.

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3.1 The evidence 20 The Respondents initially sought to rely upon reports of Dr Isaac Golden, Dr Jurgen Schulte, and Dr Donohoe. 21 The ACCC objected to much of that evidence on the grounds that the expert opinions were irrelevant, conclusionary, argumentative, disclosed no reasoning, and were incapable of being tested intelligibly in cross-examination, and that the underlying studies were hearsay and not attached to the report. 22 The report of Dr Schulte was excluded in its entirety on the ground of relevance. 23 As a result of rulings at trial and of concessions made by the Respondents, substantial parts of the reports of Dr Golden and Dr Donohoe were also not received in evidence (albeit that some of that material was nonetheless received as submission). The reports were in patently inadmissible form with no apparent regard to the rules of evidence and, in particular, to s 79 of the Evidence Act 1995 (Cth) ("Evidence Act"). An application by the Respondents at trial under s 190(3)(b) of the Evidence Act to dispense with the rules of evidence insofar as they precluded the admission of substantial parts of Dr Golden's report was also refused. 24 Dr Donohoe was a general medical practitioner with 26 years' experience who retired in 2003. He did not purport to be an expert in the prevention of disease or in the prevention or treatment of whooping cough. He had little clinical experience with cases of infant pertussis in the past decade although he had seen many adult and adolescent cases in this period. Insofar as his evidence was admitted, Dr Donohoe's evidence was largely consistent with that given by the experts called by the ACCC, as I later explain. 25 Dr Golden is an Honorary Research Fellow at the School of Science, Information Technology and Engineering at the University of Ballarat. He holds a Doctor of Philosophy from Swinburne University of Technology awarded in 2004 on the topic of Potential value of Homeoprophylaxis in the Long-Term Prevention of Infectious Diseases and the Maintenance of General Health in Recipients, together with diplomas in naturopathy and homoeopathy from the Melbourne College of Naturopathy in 1990 and the Melbourne College of Homoeopathy in 1989 respectively. To the extent that Dr Golden's report was admitted, it was largely confined by orders under s 136 of the Evidence Act to a description of the philosophical approach of homeopathy to the treatment and prevention of disease as opposed to evidence on the effectiveness of homeopathy in preventing whooping cough. The closing submissions for the Respondents repeatedly overlooked the limited basis on which Dr Golden's evidence was admitted, submitting that it showed that there is a reasonable basis in homeopathic science for the representations about homeoprophylaxis. However, given the terms of the order, his evidence simply could not be put to that use.

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3.2 Admissibility of expert opinion evidence under the Evidence Act 26 Given the extent of the apparent difficulties with the Respondents' expert evidence and the potential impact of excluding such evidence upon the Respondents' case, I delivered detailed reasons in the course of the trial for ruling inadmissible sample passages from the report of Dr Golden. It is helpful to repeat the substance of those reasons here. These reasons were illustrative of the difficulties found in the bulk of the Respondents' expert reports. 27 By s 76(1) of the Evidence Act, the general rule is that "evidence of an opinion is not admissible to prove the existence of a fact about the existence of which the opinion was expressed". This rule is known as the "opinion rule". Section 79 of the Evidence Act exempts evidence of certain opinions of experts from the general rule in s 76(1) and provides that: If a person has specialised knowledge based on the person's training, study and experience, the opinion rule [in s 76(1)] does not apply to evidence of an opinion of that person that is wholly or substantially based on that knowledge. 28 As Lindgren J held in Harrington-Smith on behalf of the Wongatha People v Western Australia (No 2) (2003) 130 FCR 424 ("Harrington-Smith") at 427 (an authority relied upon by the Respondents): By providing for an exception to the inadmissibility created by the opinion rule, s 79 goes to admissibility… the section poses an objective test; no discretion is involved; a party raising an objection to admissibility on the ground that the section is not satisfied is entitled to a ruling on the objection… 29 The test which must be applied in determining whether expert opinion evidence is admissible under s 79 was considered by the High Court in Dasreef Pty Limited v Hawchar (2011) 243 CLR 588 ("Dasreef"). The joint judgment in that decision of French CJ, Gummow, Hayne, Crennan, Kiefel and Bell JJ established in my opinion the following matters. 30 First, the expert opinion rule directs attention as to why the party tendering the evidence says that it is relevant, that is, as to the finding that the tendering party wishes the Court to make. Thus, in considering the operation of s 79(1), their Honours held at 602 [31] that it is "…necessary to identify why the evidence is relevant: why it is 'evidence that if it were accepted, could rationally affect (directly or indirectly) the assessment of the probability of the existence of a fact in issue in the proceedings.'" 31 Secondly, as Gleeson CJ pointed out in HG v The Queen (1999) 197 CLR 414 at 427 [39] in a passage approved in Dasreeef at 604 [36], "…by directing attention to whether an opinion is wholly or substantially based on specialised knowledge based on training study or experience, [s 79] requires that the opinion is presented in a form which makes it possible to answer that question". Thus, as their Honours in Dasreef later explained in their joint reasons, "[t]he point which is now made is a point about connecting the opinion expressed by a witness with the witness' specialised knowledge based on training, study or experience." (at 605 [41])." 32 Thirdly, their Honours in Dasreef held that a failure to demonstrate that an opinion expressed by a witness is based on the witness' specialised knowledge based on training, study or experience "…is a matter that goes to the admissibility of the evidence, not its weight." (Dasreef at 605 [42]; see also Honeysett v The Queen (2014) 88 ALJR 786 ("Honeysett") at 794 - 795 [44]-[46] (the Court). Thus in Dasreef, the evidence of the witness' estimate as to the volume of respirable silica dust to which the plaintiff was exposed over time in the course of his employment lacked reasons. The absence of reasons in turn was held to point inexorably to the lack of any sufficient connection between a numerical or quantitative assessment or estimate, on the one hand, and relevant specialised knowledge, on the other hand (Dasreef at 605 [42]). In this regard, I reject the Respondents' submission that the Court in Dasreef was not concerned with the absence of reasons in the expert's report, but rather there had been a failure to demonstrate that the expert's opinion had a foundation in his specialised knowledge in some other way, which the Respondents did not clearly articulate. In my view, the need to demonstrate the connection between the specialised knowledge and its application is inconsistent with the Respondents' submission: see also e.g. Honeysett at 794-795 [44]-[46]. Reasons provide the mechanism, in other words, by which the connection is exposed. In this regard, Heydon J in his separate judgment in Dasreef also makes the point with respect to the need for the reasoning to be stated, that "[t]he opposing party is not to be left to find out about the expert's thinking for the first time in cross-examination" (ibid at 623 [91]) and further that "[t]he requirement that the opinion be based wholly or substantially on specialised knowledge is an explicit precondition of admissibility. Like other preconditions under s 79, it is to be established by the party tendering the evidence. It is to be established in evidence in chief… not in cross-examination …" (ibid at 626 [99]).

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3.3 Admissibility of the evidence 33 At its heart, the difficulty with Dr Golden's report was that it cast no light upon the reasoning by which the opinions given were reached. Crucially, just as the figure reached in Dasreef as to the likely level of exposure to dust lacked reasons by which the connection between the specialised knowledge and the evidence was demonstrated, equally no such connection between the evidence as to the alleged efficacy of homeoprophylaxis in the prevention of whooping cough (or other diseases) and the application of specialised knowledge was identified by Dr Golden's report. As such, the evidence fell well short of meeting the requirements of s 79 of the Evidence Act. In those circumstances, I had no discretion. The passages in question were not admissible. 34 The Respondents sought to rely upon the breadth of Dr Golden's curriculum vitae, submitting generally that: I would put it so high as to say this is one of the most eminently qualified homeopaths in Australia and he has got dozens and dozens of articles published, many of them are relevant to international trends and experience and I just wonder if we're going to take the approach of seeing whether or not every single statement has a proper basis without reference to the curriculum vitae, then not only will it take a long time, but I will certainly feel, your Honour, that perhaps there has been some disenfranchisement going on here with the expert witness. 35 In a similar vein, the Respondents further submitted that: …perhaps, my rather abstract and tangential opening submissions on the decision in Dorber, insofar as it may be that Dr Golden is being indirectly punished in the sense that the way he references in material, and the self-referential aspects like referring to his own studies do appear to be markedly from the approaches taken by Dr Woods and Dr Crawford. In some sense, that's the nub of the problem for our expert witness, is trying to feed their evidence through this orthodox medical paradigm and all I'm saying is let's not confuse the orthodox medical paradigm with regard to how references are attached and how they're referred to for the test under the Evidence Act, because they're two separate things, and there is a danger of conflation insofar as you have eminent evidence-based medical practitioners appearing for the applicant and doing expert reports in the way you would expect of an orthodox evidence-based medical practitioner, as against a homeopath, I'm unsure of his experience with regard to building documents like this. 36 However, these submissions suffer from the same fallacies as those identified by Lindgren J in Harrington-Smith. Specifically, Lindgren J held at 427 that: Unfortunately, in the case of many of the experts' reports, little or no attempt seems to have been made to address in a systematic way the requirements for the admissibility of expert opinion. Counsel protested that, in order to ensure that the requirements of admissibility are met, lawyers would have to become involved in the writing of the reports of expert witnesses. In the same vein, counsel said in supporting the admission of certain parts of a report, that they were written in the way in which those qualified in the particular discipline are accustomed to write. Lawyers should be involved in the writing of reports by experts: not, of course, in relation to the substance of the reports (in particular, in arriving at the opinions to be expressed); but in relation to their form, in order to ensure that admissibility is attracted by noting more than the writing of a report in accordance with the conventions of an expert's particular field of scholarship. So long as the Court, in hearing and determining applications such as the present one, is bound by the rules of evidence, as the Parliament has stipulated … the requirements of s 79 (and of s 56 as to relevance) of the Evidence Act are determinative in relation to the admissibility of expert opinion evidence. (emphasis in original) 37 Nothing in that approach is inconsistent with the decision in Dasreef; indeed, in my view, the decision in Dasreef emphasises the correctness of the approach. 38 In short, the reason why the evidence in question was excluded was not because it was product of, to use the words of counsel for the Respondents, a science which operates in a different paradigm from orthodox medical science. Nor was it excluded because, as the Respondents also submitted, "…automatic superiority and automatic preference [is] given to one paradigm over the other either at the admissibility level or the weight level …" The evidence was excluded because the Respondents' evidence must comply with the same rules of evidence as those which apply to all parties under the Evidence Act, relevantly, the requirements for the admissibility of expert opinion evidence under s 79. Responsibility for ensuring that evidence is put before this court in admissible form lies with the legal representatives. It is no answer, as Lindgren J has said, to say that the expert is unaccustomed or untrained in presenting evidence in an admissible form; nor that the form in which the evidence is presented reflects the way in which material might customarily be presented within the field of expertise in question.

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4.1 Pertussis - the disease and potential complications 40 Pertussis, otherwise known as whooping cough, can be a serious respiratory disease and is caused by the bacterium Bordetella pertussis ("pertussis"). It is an exclusively human pathogen spread by respiratory droplets. It is highly infectious, spreading to 90% of "susceptible household contacts", being individuals who are not immune and live in the same house as the infectious person. Pertussis is known for the uncontrollable and violent paroxysms (bouts) of coughing experienced by those suffering from the disease at the end of which, the patient needs to take a deep breath resulting in a "whooping" sound. 41 "Classical pertussis" typically has an incubation period of 7 to 10 days followed by three phases of illness: (a) The first phase is catarrhal. This is a non-specific nasal congestion illness accompanied by a mild cough, lasting one to two weeks. (b) The second phase is paroxysmal: namely, a spasmodic cough, post-cough vomiting and inspiratory whoop which lasts for four to six weeks or longer. Facial suffusion (redness/congestion) with prominent eyes and protrusion of neck veins may be seen during these paroxysms. It can also affect infant's feeding. (c) The final phase is convalescent during which the symptoms slowly improve over one to two weeks, although the phase may persist longer. The cough may persist for a number of weeks or months and future episodes of upper respiratory tract infections may restimulate the coughing paroxysms. 42 If untreated, a person with whooping cough is contagious for at least 21 days. Whooping cough is treated by ten day course of antibiotics, after the first five days of which there is minimal chance of transmitting the disease. This means, as Dr Crawford explained, that early treatment is an important public health measure for decreasing the risk of further contact cases. However the antibiotic treatment will not stop or improve the cough. 43 Professor Phelps explained that transmission of the disease from mother to child is thought to be responsible for 38% of cases of whooping cough in children, with fathers responsible for further 17% and siblings, 41%. Dr Wood also identified infected parents and siblings as the most important source of infection to infants, stating that: Individuals with pertussis disease are most infectious during the initial catarrhal period and for the first 2 weeks of spasmodic cough, but can remain infectious for up to 6 weeks, especially in the case of non-immune infants. A probable scenario is that adults and adolescents, who become infected because of waning vaccine or disease induced immunity, act as reservoirs for infection and transmit infection to unvaccinated or partially vaccinated infants. In Australia, a national study identified a presumptive source of infection in 60% of 110 hospitalised infants, of whom 60% were parents. (Elliot E, McIntyre P, Ridley G et al. National study of infants hospitalised with pertussis in the acellular peturssis (sic) vaccine era. Pediatr Infect Dis J. 2004; 23: 246-252) In a recent study by Jardine et al in 2010, siblings have also identified as a source of infection for young infants. (Jardine A et al. Who gives pertussis to infants? Source of infection for laboratory confirmed cases less than 12 months of age during an epidemic, Sydney, 2009. Commun Dis Intell Q Rep. 2010 Jun;34(2):116-21). 44 The symptoms in older children, adolescents and adults can range from classic pertussis to a mild cough or even no cough. Young infants may present with apnoea only or an apparent life-threatening event characterised by shallow/absent breathing, slowing heart rate and cyanosis (i.e. appearing blue due to lack of oxygen). 45 Serious complications can arise from pertussis but are more common in non-immune young infants and very young infants. As Dr Crawford explained: Respiratory complications are frequent with a pneumonitis (lung inflammation), commonly seen. The secondary pneumonia (chest infection) may also occur due to B.pertussis or a secondary bacterial infection. Occasionally the pneumonia may be of a severe necrotizing form, which is the major cause of death. Atelectasis (airway mucous plugging) may occur. Severe air leak complications relate to damage to the lungs following rupture of the alveoli. They include pneumothoraces, which is air between the lung and the pleura (lining of the lung) and if large may require intervention with an underwater sealed drain. Interstitial emphysema (damage to the lungs) and pneumomediastinum (air in the chest, but outside the lung) may also occur. Bronchiectasis or damage to the airways caus[ing] them to widen and become infected is a rare late complication. Su[b]conjunctival hemorrhages of the eye, rectal prolapse or inguinal (groin) hernia may occur due to the increase in intra-abdominal pressure. Cerebral anoxia (lack of oxygen), with associated convulsions, can occur in young children and an encephalopathy (global brain dysfunction) is seen in approximately 1 in 10,000 cases. 46 Younger infants under six months are more likely to have complications such as apnoea (breath-holding) and require hospitalisation. Most deaths secondary to pertussis also occur in children under six months of age and especially those under one month old. The infection can also result in death among adults, especially the very elderly.

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4.2 The Vaccine for pertussis 47 Individuals can become immune to pertussis either by naturally acquiring pertussis or following receipt of a pertussis Vaccine. 48 All vaccines available in Australia, including that for pertussis, are approved for use and regulated by the Therapeutic Goods Administration ("TGA") under the Therapeutic Goods Act 1989 (Cth). The stated object of the Therapeutic Goods Act is to create "a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods" that are, relevantly, used in Australia: s 4, Therapeutic Goods Act. It prohibits the importation, exportation, manufacture and supply of therapeutic goods in Australia for use in humans save where the goods are registered, listed, exempt, or approved/authorised under s19 or s 19A: see ss 19(4) and 19D(1). Therapeutic goods include goods for use in "preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons" (see the definition of "therapeutic good" and related definition of "therapeutic use" in s 3(1), Therapeutic Goods Act). 49 The TGA has published guidelines for the registration of prescription medicines, including vaccines, in the Australian Regulatory Guidelines for Prescription Medicines, June 2004. 50 Before a product can be registered under the Therapeutic Goods Act, the sponsoring company must make an application with data to support the quality, safety and efficacy of the vaccine for its intended use. Dr Wood explained that the data requirements are largely based on those applying in the European Union, supplemented where necessary by Australia-specific requirements. In the case of vaccines, the premarket evaluation data includes: the quality and quality control aspects of the manufacture; pre-clinical data designed to assess the toxicological profile of the vaccine, including safety when tested in animals: and clinical (i.e., human) trial data to support the safety and efficacy of the vaccine in humans. Information from equivalent regulators in other jurisdictions that undertake a similar approval process, such as the Food and Drug Administration in the United States, may also be requested. 51 In determining whether to allow an application for registration of the therapeutic product, the Secretary must evaluate the goods for registration having regard to a number of matters including "whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established": s 25(1)(d), Therapeutic Goods Act. The term "safety" has, in my view, been used in its ordinary meaning to refer to "the quality of being unlikely to cause hurt or injury; the quality of not being dangerous or presenting a risk'": Aspen Pharmacare Australia Pty Ltd v Minister for Health and Ageing ("Aspen") [2012] AATA 362 at [19]-[20]; see also the Oxford English Dictionary (1.a. The state of being protected from or guarded against hurt or injury; freedom from danger"); Macquarie Dictionary (6th Ed; 2013) ("the state of being safe; freedom from injury or danger"). 52 Similarly, I consider that the word "efficacy" is likely used in s 25(1)(d) in its ordinary sense, namely, the "'ability to bring about the intended result' … that is, effectiveness to bring about the intended therapeutic result for which the goods have been registered…": Aspen at [21]; see also the Oxford English Dictionary ("1. Power or capacity to produce effects; power to effect the object intended"); and the Macquarie Dictionary ("capacity for serving to produce effects; effectiveness"). This view is also consistent with the statement in the Second Reading Speech for the Therapeutic Goods Bill 1989 (Cth) that, "[t]hree parameters are used to define the acceptability of a product for therapeutic use... The third parameter is the product's efficacy, or its effectiveness in fulfilling its intended purpose" (Hansard 5 October 1989, page 1612) (emphasis added). It is true that in a technical medical sense, the term "efficacy" is used in the context of randomised control trials which constitute best evidence (as I later explain at [68]-[70]). However, it seems unlikely that the Parliament would have intended to limit the concept to its technical meaning in the context of the Therapeutic Goods Act given that other data may be relevant, including that obtained by subsequent observation of the use of the drug in other countries. 53 In undertaking the balancing exercise required by s 25(1), a high level of safety is required from vaccines, which unlike most medications, are generally given to healthy people, to prevent illness and death. Dr Crawford explained that a fever in the first twenty-four hours is an expected and common side effect from the administration of a vaccine because the vaccine operates to stimulate the system to produce a new protection.

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4.3 Administration of the Vaccine under the National Immunisation Program 54 The Vaccine is administered in Australia as part of the National Immunisation Program (NIP), in common with the majority of vaccines. All of the pertussis vaccines under the NIP are acellular pertussis vaccines ("Pa"), containing three or more purified components of B.pertussis. The change from a whole cell pertussis to acellular vaccines took place in the late 1990s. The vaccine is injectable and usually given as part of a combination vaccine including diphtheria (D) and tetanus (T) ("DTPa"), and may also include hepatitis B, polio and Haemophilus influenzae type b. 55 In line with the requirements earlier outlined, the Vaccine had to be approved as a medication by the TGA before it could be included on the NIP. Dr Crawford explained the process following TGA approval by which a vaccine is added to the NIP: The vaccine is then reviewed by the Australian Technical Advisory Group on Immunisation (ATAGI), who will make recommendations about the utility of adding a vaccine to the NIP. The vaccine then requires a cost effectiveness evaluation through the Pharmaceutical Benefits Advisory Committee (PBAC)… This assessment will take into account the efficacy/effectiveness of the vaccine on available evidence and the price proposed by the pharmaceutical company. These recommendations then go to the federal government for approval through the Department of Health in Canberra before a new vaccine can be added onto the NIP. State health departments are involved in the introduction of vaccines onto the NIP program. 56 The pertussis vaccine is generally included in a combined vaccine administered by injection, the type of which varies depending on the recipient's age. 57 While pertussis vaccination schedules differ around the world, Dr Wood explained that none currently started earlier than six weeks of age. The schedule recommended by the World Health Organisation is six, ten and fourteen weeks for primary immunisation. 58 The recommended schedule in Australia is administration of the vaccine: (a) at 6 - 8 weeks, 4 and 6 months of age (the primary schedule); with boosters at: (b) at 3.5 - 4 years; and (c) during adolescence (11 - 13 years); and (d) adulthood (recommended for those who wish to reduce the likelihood of becoming ill with pertussis, such as parents of young infants, and at 50 years of age); (collectively, "the Vaccine": see Australian Government Department of Health and Aging, The Australian Immunisation Handbook (10th Ed, 2013) at 4.12.7 (the "Australian Immunisation Handbook")). 59 In relation to the recommended schedule, the Australian Immunisation Handbook advises that the booster dose at 3.5 years of age "is essential as waning of pertussis immunity occurs following receipt of the primary schedule." The Handbook also advises that the optimal age for administration of the second booster dose is 11 to 13 years "due to waning antibody response following the 1st booster dose recommended at 4 years of age. This 2nd booster dose of pertussis - containing vaccine is essential for maintaining immunity to pertussis (and diphtheria and tetanus) into adulthood." 60 In the case of adults, the Australian Immunisation Handbook recommends vaccination for any adult who wishes to reduce the likelihood of becoming ill with pertussis which is particularly important where an adult falls within a special risk group, such as health care workers and adults working with infants and young children aged less than four years. With respect to those in contact with infants, the Handbook advises that "[t]here is significant morbidity associated with pertussis infection in infants 20 years of age decreased to 57%. The greatest increase in notification rates occurred in 3-year-old children." Based upon the NNDS data, Dr Wood observed that there had been a "recent rise in pertussis incidence" and "considerable rises in notifications" in children aged under 4 months and those aged 18 months to 4 years, in particular in 2008-2009, and that this is so notwithstanding a high degree of compliance with the NIP in the Australian community. The spike in notifications in 2008-2009 and earlier spikes are depicted in the graphs reproduced in Dr Wood's report: 216 A similar spike in pertussis notifications in Australia since 2008, including in Victoria, was noted by Dr Crawford. Dr Crawford also observed that, while the number of pertussis cases started to decrease in mid-2012, high numbers of cases continued to be notified in Australia and internationally. 217 Increases in the incidence of pertussis of this kind in part reflect a recurring pattern with respect to whooping cough. As the Australian Immunisation Handbook states at [4.12.3], "[d]espite a long outstanding immunization program, pertussis remains wholly present in Australia and the least well-controlled of all vaccine - preventable diseases. Epidemics occur every 3 to 4 years." Similarly, Dr Crawford explained that: … pertussis often will increase. Every 3 to 4 years you will have a bit of an increase. The exact mechanism is not fully understood but it is a circulating bacteria that's hard to eradicate and when it does start, it then does spread quite quickly. So if you look at a graph over history over time, there will be, every three to four years, a bit of an increase in pertussis cases seen in both Australia and also internationally. That's sort of the nature of pertussis as a disease… 218 In this regard it will be recalled that the disease is highly infectious and a person contracting the disease remains infectious for at least 21 days, and possibly up to six weeks, if untreated: see at [40]-[42] above. Added to this, adults in particular may present with mild symptoms only as a consequence of which the disease may not be diagnosed or only diagnosed late in the progress of the disease. As Dr Crawford explained, a person with whooping cough may present, for example, only with a chronic cough as a result of which they seek assistance from their general practitioner only after the cough has persisted for some time.

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7.5.3 Were the Vaccine representations misleading or deceptive if read in the context of the epidemic? 219 The first difficulty with the Respondents' submissions is that neither the First nor the Second Vaccine Representations are limited to the context of an epidemic or to any specific age group. As such, the submission that the representations that the Vaccine is short-lived and unreliable should be read in this context fails to grapple with the fact that the reader is simply not informed of the limited context by reference to which it is now said that the representations should be understood. 220 In any event, even if the representations that the Vaccine is short-lived and unreliable are sought to be justified by reference to the existence of the epidemic (which seems to be the only way in which to make sense of the Respondents' submission), they remain in my view misleading, deceptive and false. 221 First, even during the epidemic, the Vaccine has been effective in significantly reducing the incidence and severity of the disease, including the instances of mortality. As the Australian Immunisation Handbook states: In unvaccinated populations, these outbreaks can be very large. In vaccinated populations, outbreaks are smaller, with greatly reduced mortality and morbidity, and may continue to occur every 3 to 4 years or be more widely spaced. 222 Thus notwithstanding the high rate of notifications in Australia in 2009-2010, the authors of the Australian Immunisation Handbook considered that: In contrast to notifications, hospitalisation and death rates from pertussis in the most recent epidemic period has not increased substantially. A high proportion of hospitalisations, and almost all deaths, attributed to pertussis occur in infants too young to have received more than 1 dose of pertussis-containing vaccine. 223 The Respondents' evidence was consistent with these views. I have already referred to the evidence of Dr Donohoe accepting the effectiveness of the Vaccine to protect the very young against whooping cough and against more severe forms of the disease, if contracted, when the Vaccine has been administered to them in accordance with the NIP schedule: see above at [171], [180] and [197]. Dr Donohoe also accepted generally that the course and severity of the illness is significantly altered by prior pertussis vaccination and/or prior infection with pertussis and, in either case, the severity is usually less than it would have been no prior exposure to the pertussis antigens. Consistently with this, he considered that complications arising from pertussis following vaccination would be expected to be less than complications arising from a first infection in an unvaccinated person. He did not differentiate in his evidence between periods in which there was an epidemic and other periods. 224 The impact of high rates of pertussis immunisation was also illustrated by Professor Phelps' unchallenged evidence of reduced incidence of the disease in areas of high vaccination, namely that: Epidemiological studies have established the effectiveness of pertussis vaccination programs, which rely on high uptakes of the vaccine to increase herd immunity. The most recent of these has recently been published in Pediatrics journal. The investigation into California's 2010 pertussis outbreak, the state's most severe in more than 60 years, shows a direct overlap between the geographical distribution of conscientious objectors and the spread of pertussis. After mapping the two, researchers concluded that clusters with high conscientious objection rates were 2.5 times more likely to be hit by pertussis than other areas. Individuals living in such a cluster had a 20% higher incidence than those living elsewhere. This is clear epidemiological demonstration of the success of high rates of pertussis immunization. (references omitted) 225 I have already referred to evidence establishing that the case-control-level methodology, such as that applied in this example, provides a strong means by which to measure the effectiveness of a vaccine (see above at [193]). 226 Secondly, the reasons underlying the spike in notifications and pertussis incidence are multifactorial and only partially attributable to an increase in the number of cases of whooping cough. Thus, the Australian Immunisation Handbook considered that increased and more sensitive diagnostic testing using polymerase chain reaction ("PCR") has contributed to the rise in notifications in 2009/2010. Dr Crawford expressed like views. In this regard, Dr Crawford explained that the use of PCR laboratory testing for whooping cough (which requires a sample to be taken within three weeks of the illness onset) is the more rapid test and the "gold standard", as opposed to the serology for whooping cough used a cellular in the 1990s. The latter involved taking a blood sample and testing for the antibody against whooping cough in the blood with the results being problematic and hard to interpret. Dr Crawford also referred to increased testing for pertussis due to increased health professional awareness as contributing to the increase in notifications. Similarly Dr Wood considered that improved diagnostic techniques and reporting have made a major contribution to increased notification rates for pertussis. In his view, this is likely to be associated with a marked increase in the volume of tests performed primarily by laboratory method, with public funding in Australia for public laboratories to test specimens for pertussis under the Medicare Benefits Schedule having commenced in November 2005. He further considered that increased press reports and scientific literature on the "resurgence of pertussis" may have also increased clinician awareness and reporting, as well as the availability of laboratory based tests as a diagnostic tool. 227 Thirdly, the evidence established that the increased notifications are likely to be attributable also to an increase in the actual incidence of the disease. This accords with the typical pattern of the disease at a population level which is being observed internationally to which reference has already been made. There were a number of possible factors at play for the increase in the number of cases, including: a) waning immunity following infection and vaccination: The Australian Immunisation Handbook observed that vaccine effectiveness among 3-year-old has been estimated at around 60%, consistent with waning of immunity following the primary DTPa course. Dr Wood also gave evidence that waning immunity following infant vaccination, was a contributing factor with estimates of the duration of protection following acellular pertussis vaccination being approximately 5-6 years. Furthermore, in his view, recent increased rates of pertussis in children aged 18 months to 4 years may be related to waning antibody levels in the second year of life following the removal of the Vaccine given at 18 months from the Australian vaccination schedule in 2003. b) incomplete protection from vaccination: Consistent with the views expressed in the Australian Immunisation Handbook, Dr Wood also pointed to the fact that over half of the pertussis cases between 1994 to 2009 occurred in infants under 3 months, with infants under 4 months being too young to have received the two or more doses of the Vaccine needed for protection. c) infection source for infants: Conversely, Dr Wood pointed to the fact that adults, particularly parents, and siblings of infants, may become infected because of waning vaccine or disease induced immunity, and thereby act as reservoirs for infection and transmit the disease to unvaccinated or partially vaccinated infants. This is potentially compounded by what Dr Crawford described as the "non-specific nature of the illness (prolonged cough) in older children, adolescents and adults". In other words, persons infected with the disease in this category may be unaware that they have whooping cough but still highly infectious. d) strain polymorphism: Finally Dr Wood explained that it has been suggested that Bordetella pertussis has adapted to express pertussis toxin and pertactin strains distinct from the vaccine strains. In other words, as Dr Wood explained in his evidence, while the Vaccine is intended to cover all of the different strains of the pertussis bacteria, each time the bacteria replicate, they can mutate or change raising the possibility of a strain that can evade vaccine-induced immunity and thereby become the dominant strain. 228 Aside from the last of these factors, administration of the Vaccine in accordance with the NIP schedule, including ensuring vaccination at levels to provide herd immunity and following the cocooning strategy, provides means by which these contributing factors can be addressed, as well as the kinds of practical measures referred to by Dr Donohoe to ensure early diagnosis with appropriate responses to minimise risk of infection. Thus, Dr Crawford explained that the public health response of most state health departments to this period of high disease burden of pertussis was to take steps to minimise the risk of infants contracting whooping cough. Specifically, he explained that: On 15 June 2009, in response to the epidemic, the Victorian Government Department of Health introduced a time-limited free vaccination program for parents of new babies (the so called 'cocooning' strategy). All other states and territories (with the exception of Tasmania) implemented similar programs to parents of young children. This was administered to mothers as soon as possible after birth and to fathers during the pregnancy. Some states, such as the NSW, also funded the vaccine for grandparents. 229 The majority of states, including Victoria, ceased the program in 2012 as the number of whooping cough cases was decreasing. 230 The Vaccine also continues to be kept under review and updated by the Cochrane Review which may lead to adjustments to the NIP if considered likely to increase protection in light of further evidence. In this regard, Dr Crawford referred to current studies reviewing the impact that the state-funded parental programs had on the whooping cough epidemic. 231 As to the last factor in paragraph 227, despite evidence of polymorphism for pertussis toxin and pertactin in several countries, there was no challenge to Dr Wood's evidence that no direct link to vaccination programs or efficacy has been proved. Similarly, Dr Crawford observed that "[s]ome changes to the pertussis strains [Octavia et al. Newly Emerging Clones of Bordetella pertussis Carrying pm2 and ptxP3 Alleles implicated in Australian Pertussis Epidemic in 2008-2010. J Infect Dis. 2012; 205(8): 1220-4.] have been detected in small numbers of samples and it's role in the epidemic requires further research." 232 It follows in light of these explanations, in my view, that it affords no answer to the misleading and deceptive nature of the Vaccine representations to point to the existence of the spike in notifications in 2008, 2009 and 2010. The Respondents seek, in effect, to rely upon the fact of the increase in incidence and notifications of the disease out of context, i.e., apart from the explanations, for the increase, divorced from the strategies that exist to respond to the increased incidence of the disease, and ignoring the significant impact that the Vaccine has had to reduce the incidence and severity of the disease during the epidemic in 2008, 2009 and 2010 and generally. When those matters are taken into account, in my view the evidence of the existence of the epidemic does not dispel the misleading, deceptive and false character of the Vaccine Representations.

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7.5.4.1 The First Whooping Cough Article 234 First, with respect to the First Whooping Cough Article, Mrs Sheffield explained that the article entitled "Pertussis: The Fear Factor" by Meryl Dorey ("the Fear Factor article") which had appeared in the magazine Living Wisdom, "formed part of the basis my thinking when drafting the First Whooping Cough commentary [i.e., the First Whooping Cough Article]". A hyperlink to that article was provided at the base of the First Whooping Cough Article under the heading "Further Reading". Mrs Sheffield explained that: Table 4 of the [Fear Factor] Article concerned me because it showed that prior to mass vaccination against whooping cough children were catching pertussis when they were older. The statistics in the article show that in Poland and the United States it was after mass vaccination started that children were getting whooping cough more often at an earlier age (infancy) which I know is the danger period for this infection." (the text in italics was admitted for non-hearsay purposes only) 235 However, as Mrs Sheffield rightly conceded in cross-examination, the data in table 4 of the Fear Factor article said nothing about either the total number of cases of children getting whooping cough or the frequency of those cases. It purported to set out only the "percentage distribution of pertussis cases" among children of different age groups before and after widespread use of the vaccine in Poland in 1971 and 1991 and in the United States in 1918-1921 and 1980-1989. As such, it did not support the statement that children were getting whooping cough more often in infancy after the introduction of mass vaccination. Nor, as Mrs Sheffield properly conceded in cross-examination, did table 4 say anything about whether administration of the vaccine has modified the effects of the disease within any particular age group. Moreover when asked whether she had informed herself in drafting the First Whooping Cough Article as to the kinds of whooping cough vaccine administered in the US and Poland in the periods to which the data in table 4 related, Mrs Sheffield answered "Not especially because when I was reading that article, I was thinking it was in some way similar to what I was seeing happening in Australia". Her answer demonstrates a preparedness to make assumptions without undertaking even basic inquiries or research. 236 Similarly, Mrs Sheffield gave evidence that "[i]n the First Whooping Cough commentary I said 'side effects are common' when discussing the vaccine. This conclusion sums up the information under the heading 'A long history of side effects' in the Fear Factor article." However, as Mrs Sheffield conceded in cross-examination, the Fear Factor article does not state the actual occurrence of side effects from the use of the acellular Vaccine. It purports to reproduce only the list of potential side effects which are noted as a warning on the medication by the manufacturer. As such, the statement by Mrs Sheffield that "side effects are common" did not in fact sum up the information under the heading in the Fear Factor article.

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7.5.4.2 The Second Whooping Cough Article 237 With respect to the Second Whooping Cough Article, Mrs Sheffield initially stated that she had undertaken what she described as "extensive reading and research" between uploading the First and Second Whooping Cough Articles. However, far from being an expert, she was not, even on her own admission, across the research or detail on vaccination. 238 Moreover, material relied upon by her was not accurately reflected in the article. In this regard, it will be recalled that the Second Whooping Cough article contained links under the heading "Further Reading" to two further articles, including the 2009 Emerging Infectious Diseases article: see at [89] above. Mrs Sheffield relied on the 2009 Emerging Infectious Diseases article as part of her "fact-checking" before uploading the Second Whooping Cough Article. Nonetheless, she properly accepted in cross-examination that the Second Article did not reflect the authors' conclusion that their results suggest that "an effective way to control pertussis is the improvement of current vaccines" in the manner suggested. 239 Mrs Sheffield's thinking on vaccine efficacy in preparing the Second Whooping Cough Article was particularly influenced by an ABC News radio story to which she listened in the months after the First Whooping Cough Article. She said that she remembered the story well because "a doctor from Westmead Children's Hospital was asserting the same things in her interviews with the ABC journalist as I had been asserting in my original article which the ACCC had requested I take down." However, while the doctor from Westmead Children's Hospital referred to an increase in cases of whooping cough in Australia and to the possibility that one reason for that may be a new strain which is less affected by the Vaccine, she also said that "[t]here's no doubt that the current vaccines have a significant protective effect." As Mrs Sheffield acknowledged, that was not reflected in the Second Article. Indeed it is directly contrary to the Second Vaccine Representation. Similarly, in the same interview another doctor from New South Wales Health said that "… the vaccine, which has been around since the 50s, has continually improved in the last several years to make it more effective. And so while it's not a perfect vaccine it has been effective in avoiding death from this nasty childhood disease." Again, that statement found no reflection in the Second Whooping Cough Article, which Mrs Sheffield sought to explain simply by asserting that the statement was inaccurate. 240 In addition to relying upon these articles and the ABC News radio story, Mrs Sheffield read a number of other articles, referring in her evidence to seventeen by their title only as a sample of the kind of commentary read by her. While the Respondents tendered brief notes prepared by Mrs Sheffield in the course of her research for the revised article, I cannot afford any weight to Mrs Sheffield's notes. The material to which the notes related was not tendered in evidence by the Respondents save for those referred to at the end of the Second Whooping Cough Article. Nor was any attempt made to demonstrate the standing of the authors or of the publication in which the articles appeared

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7.5.4.4 Conclusions on the material relied upon by Mrs Sheffield in support of the Three Articles 244 It is apparent for the reasons set out above that Mrs Sheffield's evidence fell well short of providing any credible basis for the Vaccine Representations. The evidence also shows that Mrs Sheffield was selective in her use of some of the material which she identified as forming part of the basis of her thinking in writing the Three Articles, with only those aspects of the material in question which were "anti-vaccine", that is, consistent with the Vaccine Representations, being reflected in the three articles. 245 In reaching this view, while intention is not a necessary element of the causes of action created by ss 18 and 29 of the ACL, I do not find that she intended to mislead or deceive by making the Vaccine Representations Rather, I consider that her admission that she is a "passionate advocate of homeoprophylaxis" and that this passion leads her to advocate against vaccination because she believes homeoprophylaxis is the better approach, are the reason why she consciously or subconsciously drew only upon those aspects of the material she read which supported her views. Added to this, she lacked any relevant expertise in vaccines, medicine and science. That lack of expertise, which is evident in her misconstruction of some of the material she read and in assumptions that she was prepared to make, demonstrates all too clearly the accuracy of her frank admission that: I often tell other people that I am not an authority on all of the problems with vaccines; that's not my area of expertise. I focus on homeoprophylaxis. When I have been approached by, let's say, anti-vaccination groups, that's what I always tell them, that if they want my input I can provide input in the area of homeoprophylaxis, but don't expect it on the area of vaccines because that's not my - while I am aware of the concerns, and I have some concerns as well, I am not into all of the research or the detail there. I read the literature but I don't store it away and catalogue it. I read it enough to think, "Yes, I think homeoprophylaxis is a fine alternative." (emphasis added) 246 Mrs Sheffield's evidence that she was incredibly busy at the time of preparing both the First and Second Whooping Cough Articles and wanted to get the information out quickly tends to suggest that she was rushed, and may also explain in part the erroneous assumptions made by her in her consideration of some of the material on which she relied. 247 However, the subject matter of the Vaccine Representations is a serious matter, and the publication of false, misleading and deceptive representations about their effectiveness has potentially very serious and dangerous consequences for those who may follow that advice and their families. These matters call for great care before representations are made to the general public about such matters where the representations imply, as here, that there is an adequate basis for the representations in medical science.

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7.6.1 The First and Second Whooping Cough Articles imply there is reasonable basis in medical science for the representation 248 It follows from my earlier analysis of the Homeopathy Alternative Reasonable Basis representations in the First and Second Whooping Cough Articles that the ACCC correctly submitted that, read in context, they imply that there is "one free-market paradigm within which both the vaccine and the alternative homeopathic prophylaxis can be assessed and compared," at least insofar as the representations are concerned, and that homeopathy provides a safe and effective alternative: see above at [143]-[151] and [162] respectively. Equally, I have found that, when the Government Article is read together with the Second Whooping Cough Article, the impression is that homeopathy provides an effective and safe alternative to the Vaccine in medical science: see above at [165-166] above. 249 The position is therefore analogous to that in Noone v Operation Smile (Australia) Inc. (2012) VSCA 91 ("Noone"). In Noone, the Respondents operated a complementary medicine centre specialising in cancer treatment which contained statements regarding the efficacy of treatments offered by the clinic. The Director of Consumer Affairs (Victoria) alleged that, by making those statements, the Respondents had engaged in misleading or deceptive conduct in trade or commerce contrary to s 9(1) of the Fair Trading Act 1999 (Vic), namely, that they had falsely represented that the treatments in question were effective in treating cancer and secondly that they had scientific support. Nettle JA (with whose orders Warren CJ and Cavanough AJA relevantly agreed at [34]) found that, notwithstanding that parts of the Website in question distinguish between conventional medicine and the so-called "complementary therapies" offered, "the net effect of the first impugned statement [namely that the Hope Clinic 'provides peer-reviewed and published methods for cancer treatment…'] in the context in which it appeared, was in my view plainly to imply that the methods of treatment offered by Hope Clinic were just as scientifically based and rigorously tested as those of conventional medicine." (at [58])

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7.6.2 Quality of evidence required 250 Given that the Homeopathy Alternative Reasonable Basis representations represent that there is a reasonable basis in medical science for the use of homeopathy as a safe and effective alternative to the Vaccine, I consider that evidence demonstrating a similar or better impact on reducing the incidence and severity of whooping cough would be necessary to support the efficacy of homeoprophylaxis as an alternative to the Vaccine, in line with the evidence of Professor Phelps. Further, that evidence would have to be evidence of the same quality as that supporting the efficacy of the Vaccine. This follows logically from the fact that whooping cough is a potentially life-threatening disease, particularly in infants and the elderly, for which an effective Vaccine is already in existence and used in Australia and internationally. 251 As Professor Phelps explained: The current conventional pertussis vaccine has substantial population studies to show that children and adults who are protected by conventional pertussis vaccination have a far less likelihood of getting the disease. Given that it's not a perfect 100 per cent prevention measure - it's in the order of 80 to 90 per cent prevention - then the people who have been vaccinated have less severe disease, and I think we have to bear in mind that pertussis is a potentially life-threatening disease, particularly in babies and in older people. And we have population studies to demonstrate that you have less pertussis and it is less severe when substantial numbers of people in the population are vaccination (sic) and in individuals who have been vaccinated. On the contrary, when it comes to so-called homeopathic vaccination - in fact, I would dispute that there even is such a thing - there are no studies of efficacy in individuals or in populations of pertussis prevention using homeopathic remedies of any sort. And what level of evidence do you believe such studies would have to reach in order to support a claim for the use of homeoprophylaxis for the prevention of whooping [cough]? What level of evidence? ---It depends on who you're trying to convince. I think if you have a properly conducted trial, it would be difficult - you would need to prove that homeopathic vaccination in a population was able to have a similar impact on reducing the incidence and severity of pertussis. In doing that, you would need to find a population which didn't have access to conventional immunisation but we do have proof that pertussis vaccination in conventional immunisation is effective. There is no proof at all that homeopathic remedies of any sort will have any impact on reducing the incidence or severity of pertussis.

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7.6.3 No published evidence within accepted levels to support the alleged effectiveness of homeoprophylaxis to treat whooping cough 252 There is, however, no published evidence within the accepted levels of evidence based medicine to support the submission that homeopathic treatments are effective in preventing whooping cough. The only scientifically proven intervention for preventing whooping cough is immunisation by administration of a pertussis containing vaccine in accordance with the NIP or similar schedule. Indeed, no evidence before the Court supported the contention that any homeoprophylaxis specifically directed to the prevention of contraction of whooping cough has been subjected to any rigorous scientific testing. To the contrary, the evidence of Dr Wood, Professor Phelps and Dr Crawford established that no credible evidence supported the efficacy or effectiveness of homeopathic treatments for the prevention of whooping cough. 253 First, Dr Wood undertook a search of Embase and Medline, to identify any academic publications relating to the safety and effectiveness of pertussis homeoprophylaxis. Embase and MEDLINE are databases recognised and used by medical practitioners in Australia. MEDLINE is a United States government supported search engine of peer-reviewed journals of international repute in medicine, health and allied areas. Dr Crawford, who also undertook searches on Medline, considered that any scientific research being undertaken internationally would use MEDLINE is one of its main scientific research data bases. 254 Professor Phelps explained the significance attributed by practitioners operating in a scientifically-based manner of the results of appropriately conducted scientific trials being published in peer review journals, namely: … the scientific journals where information is published is the dissemination of findings, the sharing of scientific findings based on properly conducted trials. Now, the significance of review by appropriately qualified professionals or peers is that you get independent eyes looking at the methods to make sure that the methods are robust; you get independent eyes looking at the conclusions to make sure that based on the method and the results that the conclusions can be drawn. And it's important that you have that independence because you might pick up flaws, for example, in the robustness or the methodology that was used, and until you have a peer-review process then you can't really be confident that, I guess, all of the glitches have been worked out of the research that is being done and questions need to be asked. And quite often a paper will be submitted to a journal and peer reviewed and then sent back to the original authors for clarification or for correction, and it's a checks and balances process to ensure that material that is published has passed through independent eyes." 255 Not surprisingly, therefore, the quality of the peer review undertaken by particular journal is one of the factors contributing to the regard in which a particular journal is held by the scientific community. 256 Dr Wood searched the databases using a variety of terms, including specific terms used by Homeopathy Plus, such as Drosera and Pertussinum. Medline was searched for articles relating to the pertussis homeoprophylaxis from 1946 until April (week 4) 2013, while Embase was searched for similar articles between 1974 and 1 May 2013. On the basis of the abstracts of articles located in the database searches, Dr Wood sought the full text of those articles which he considered may be useful on the question of the effectiveness of pertussis prophylaxis. He found a total of 20 articles as a result of the searches on Medline and 57 on Embase. Those literature searches failed to identify any level 1 or 2 studies comparing prophylaxis with placebo in a blinded manner. 257 Otherwise, Dr Wood located one abstract from the European Journal of Integrative Medicine (2012) that described a "single blinded clinical trial" of 112 children aged one to two months of age, divided into two groups of 61 participants each. The study was said to show that among a group prescribed homeopathic remedies, 22% of patients developed milder forms of certain diseases including measles, chicken pox, rubella, mumps and whooping cough while 84% of the allopathic group (i.e.: those administered a vaccine by injection) was said to have developed strong and/or severe forms of these diseases. However Dr Wood was unable to locate the complete paper as it was a publication from a conference. His evidence that it was a difficult abstract to understand and that he did not believe it presented convincing evidence of the effectiveness of pertussis homeoprophylaxis was unchallenged. 258 Dr Wood also located an article entitled, "Pertussin 30mpreventive for whooping cough" by J.M. English and published in the British Homeopathic Journal in 1987 ("English article"). He considered that the article was "inconclusive" on the use of pertussin 30 as a possible preventive for whooping cough. As the abstract of the article stated, "[i]t was recognized that neither the numbers involved, nor the method followed would of themselves be sufficient to prove efficacy, but it was hoped that a positive result would permit the conclusion to be drawn that a further study would be in the public interest." This is consistent with the views expressed in the editorial on the article published in the same volume (exhibited to Dr Wood's affidavit) which stated that: It is far from clear whence the idea that Pertussin might be effective in the prophylaxis of whooping cough emanated; certainly no such claim is made in any of the main homeopathic material medicas. …in this issue we publish the results of a survey by Dr John English on the effect of Pertussin 30 in whooping cough prophylaxis. Without in any way detracting from Dr English's most important and timely effort, it is unfortunately true that the only firm conclusion that can be drawn from his study is that the resources available to him were not sufficient to allow any definite judgement on the efficacy or otherwise of Pertussin in whooping cough prophylaxis. 259 Dr Wood's opinion regarding the lack of weight that could be given to these articles was not challenged. While Dr Golden referred to the English article in an appendix to his report, he did not annex it unlike other articles to which he referred. He accepted in cross-examination that he did not mention in his report any of the limitations or deficiencies in the methodology which qualified the reliability of the study as described by the author of the study in the article. 260 Furthermore, Dr Wood found no articles relating to the use of Drosera or Pertussinum in the prevention or treatment of pertussis in Medline Embase save for one mentioning "sundew" (drosera spp) as a treatment for pertussis. However, it lent no support to the Respondents' case as it noted only that there is very little "clinical research on treatments for whooping cough and, as might be expected, published research on the botanical remedies for pertussis is lacking". 261 Finally, Dr Wood searched the journal Homeopathy using the search term "pertussis" and found no articles published in the last fifteen years that specifically mentioned trials investigating pertussis prevention. He located, however, an article published in 1987 which mentioned the use of Pertussin and noted that claims that it was safe and effective for the prevention of pertussis are "unsupported". 262 On the basis of his research, Dr Wood therefore did not consider that there was a reasonable basis in medical science to state that homeopathic treatments, including Drosera rotundiflora and pertussinum, are effective alternatives to the Vaccine. 263 Searches undertaken by Dr Crawford led him to the same view. He undertook a literature review of Medline for the period 1996-2013 regarding homeopathy and whooping cough, utilising appropriate search terms. He identified a total of forty-two studies, none of which had any evidence to support the statement that 'homeopathy is a safe and effective alternative' to the Vaccine. Nor did the systematic literature review of complementary medicine used in children by Hunt & Ernst et al. (Hunt K, Ernst E, The evidence base for complementary medicine in children: a critical overview of systematic reviews. Arch Dis Child. 2011; 96(8);796-76) cited by Dr Crawford find any evidence supportive of homeopathy in the management of illnesses such as pertussis. Dr Crawford concluded that in his opinion there is no reasonable basis in medical science to State that homeopathic treatments are safe and effective as an alternative to the Vaccine.

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7.6.4 No support for the use of homeoprophylaxis to prevent whooping cough by peak medical and homeopathic bodies 264 In line with the lack of published evidence supporting the asserted effectiveness of homeopathic treatments for whooping cough, the consensus based on medical science is that homeopathic treatments are not an effective alternative to the whooping cough vaccine for the prevention of whooping cough. 265 This is the opinion of the Australian Medical Association. It is also the view expressed in the 2013 edition of the Australian Immunisation Handbook which states that "[h]omeopathic 'immunisation' has not been proved to give protection against infectious diseases; only conventional vaccination produces a measurable immune response." Similarly, the Victorian Government has advised that: "[h]omeopathic immunisation is not a recognised form of immunisation and is not acceptable under the legislation, therefore cannot be listed on an immunisation status certificate." 266 Nor do peak bodies for homeopathy recommend homeoprophylaxis as an alternative for the vaccination. The Australian Register of Homeopaths ("ARH") has acknowledged that: "[n]o scientifically rigorous attempt has been made to compare the effects and effectiveness of HP (homeoprophylaxis) with those of immunization" and that patients should "understand that evidence for the effectiveness of HP is limited and is not accepted by public health authorities". The ARH also advised in a statement given in August 2010 that "homeoprophylaxis should not be recommended as a substitute for immunisation". Advice to the same effect from the Australian Register of Homeopaths is set out in a fact sheet published by the National Centre for Immunisation Research and Surveillance ("NCIRS"). 267 Similarly, the British Homeopathic Association recommends that people receive conventional immunisation and that homeopathic preparations "should not be recommended as a substitute for [conventional] immunization." In cognate terms, the Council of the Faculty of Homeopathy, London, issued a statement in 1993 advising that it "…strongly supports the conventional vaccination program and has stated that vaccination should be carried out in the normal way, using the conventional tested and proved vaccines, in the absence of medical contraindications." 268 In short, the only treatment currently approved for use and accepted by medical practitioners in Australia for the prevention of whooping cough is the combined pertussis vaccine. There is no evidence of any support even among peak homeopathic associations for the use of homeopathic treatments as an alternative to the Vaccine, nor any published literature that supports the efficacy or effectiveness of homeopathic treatments as an alternative to the Vaccine.

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7.6.5 The leap of logic required by the "principle of similars" 269 Finally, Dr Golden described that the principles and practice of homeopathy encompassed prevention and treatment, and that the "principle of similars", one of two fundamental tenets of homeopathy, could be stated in the following terms: Treatment: A substance which is capable of producing symptoms in a healthy person can remove similar symptoms in an unwell person…. Prevention (may be stated in two ways): (a) A substance which is capable of producing symptoms in a healthy person similar to the characteristic symptoms of an infectious disease, is capable of preventing symptoms similar to those characteristic symptoms in a previously unprotected person... (b) A substance which is capable of removing the characteristic symptoms of an infectious disease in an infected person, is capable of preventing symptoms similar to the characteristic symptoms of the disease in the previously unprotected person. 270 In short, he explained that "[o]nce the method can be shown to be effective to prevent one disease then it follows that it will be similarly effective for the prevention of other diseases (provided the fundamental principles are correctly followed in the selection and administration of remedies)." 271 Despite this evidence falling far short of complying with the rules as to expert opinion evidence as I have earlier explained at [38] above, it was admitted subject to an order under s 136 of the Evidence Act limited to a description of the philosophical approach of homoeopathy to the treatment and prevention of disease. 272 In any event, as the ACCC submitted, no evidence supported the philosophical approach of homeopathy as described by Dr Golden, that once a method has been shown to be effective to prevent one disease, it follows that it will be similarly effective for the prevention of other disease. The proposition requires a leap of logic that cannot be made. It cannot obviate the need for evidence to demonstrate the effectiveness of a treatment to prevent a specific disease - especially where the symptoms of the disease are potentially severe and even life-threatening particularly to infants and an effective vaccine already exists. As Professor Phelps explained: … if there is a report, for example, an isolated case report of apparent efficacy in one area of therapy that you cannot then make a leap of logic or a leap of faith that proof, no matter how limited or how extensive, of efficacy of one particular substance in one particular application can, indeed, be applied to another situation or another application. So that's the leap of logic that cannot be made unless you have specific evidence for a specific product in a specific situation 273 That "leap of logic" is, as Professor Phelps further explained, analogous to assuming that, because an antibiotic is effective against a particular infectious disease, it can be used to treat other infectious diseases notwithstanding that there was no proof as to its efficacy for the treatment of those other diseases. As Professor Phelps said: It requires a leap of logic at every level. It requires a leap of logic if you are assuming that one way of treating a - any disease will apply to every other disease. I mean if you look at medical science, we have multiple ways of approaching multiple different pathologies, and in the practice of any discipline in health care, there are many different ways and methods of treating disease and many different approaches that might be used, and so when you talk about a method, there are different methods that apply to different situations, but in this respect I took this to mean that any one treatment or any one method or any one approach to treating disease cannot be applied without going through the steps of logic to other diseases and without providing evidence of effectiveness….. there would need to be some scientific evidence, or again some technical evidence of the reasons why that approach would be said to be efficacious. 274 This is not to suggest, as the ACCC accepted, that no aspects of, or disciplines within, complementary and alternative medicine could ever qualify their claims within the hierarchies of evidence based medicine. Certain complementary medical treatments, such as St John's Wort, have become more accepted where they have undergone a scientific evidence-based approach and the results have been published in peer review journals of repute. As Professor Phelps explained, "...you quite often will get experiential learning [i.e. from experience or observation], case reports that are published that raises the curiosity of the scientific researchers and then they set out to prove particular applications, but you again can't make the leap of logic that because fish oil works for secondary prevention of heart disease in a certain number of people or it reduces the risk in a certain number of people… that it will prevent pertussis, for example.".

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7.7.2 Relevant principles 276 No disclaimer, as the ACCC submitted, necessarily affords absolution from committing a contravention of s 18 or 29 of the ACL. As Williams and Keane JJA held in Downey v Carlton Hotels Asia Pacific Pty Ltd [2005] QCA 199 ("Downey") at [82] (citing Bowler v Hilda Pty Ltd (1998) 80 FCR 191 at 207), it is well established that: … exclusionary and disclaimer clauses cannot override the statutory prohibition against misleading and deceptive conduct or prevent the grant of appropriate statutory relief where loss or damage is, as a matter of fact, caused by a contravention of the statute. 277 Rather, whether a disclaimer modifies the conduct alleged to be false, misleading and deceptive is a question of fact: Butcher v Lachlan Elder Realty Pty Ltd (2004) 218 CLR 592 ("Butcher") at 613 [72]. Thus, Gleeson CJ, Hayne and Heydon JJ accepted in Butcher at 614 [72] that the conclusion was open to Burchett J in Benlist Pty Ltd v Olivetti Australia Pty Limited [1990] ATPR ¶41-043 at 51,590 to find as a matter of fact that a disclaimer in marketing material said to be misleading and deceptive had not modified the conduct in question, even though different conclusions were open in other cases. In the passage referred to, Burchett J had said: It has been held on many occasions that the perpetrator of misleading conduct cannot, by resorting to such a clause, evade the operation of [the Act]. Of course, if the clause actually has the effect [of] erasing whatever is misleading in the conduct, the clause will be effective, not by any independent force of its own, but by actually modifying the conduct. However, I should think it would only be in rare cases that a formal disclaimer would have that effect. ... In the present case, the suggestion of the suitability of the building for strata title conversion might continue to influence the mind of a prospective purchaser notwithstanding his awareness of the existence of a disclaimer clause, which did not single out the particular representation, but purported to apply generally to every detail stated in the investment report. If it were permissible to avoid the operation of [the Act] by such a clause, it would be all too easy to make representations in the confidence that they would be acted upon, and then withdraw them in the confidence (equally important for the securing of the desired business) that the withdrawal would not be acted upon. (emphasis in orginal) 278 Similarly, McHugh J in Butcher at 640 [157] (in dissent but not relevantly on the matter of principle) referred with approval to the accepted line of Federal Court authority that: …a disclaimer is only effective if it actually modifies the impugned conduct such that the conduct as a whole may be seen as not misleading, not because the disclaimer has any independent force of its own. … A disclaimer in a promotional brochure may purport to represent that the corporation does not accept responsibility for the accuracy of the information in that brochure, but it will only be effective if it operates to modify the corporation's conduct. 279 In this regard, his Honour also observed at [158] that "[t]he case law suggests that disclaimers that appear in small print at the foot of marketing brochures are rarely effective to prevent conduct from being found to be misleading or deceptive or likely to mislead or deceive." 280 To similar effect, Williams and Keane JJA held in Downey at [83], that "…disclaimers can be effective 'if the clause actually has the effect of erasing whatever is misleading in the conduct'" (emphasis added; citations omitted). Their Honours continued: It has been recognised, however, in other words, if the effect of the disclaimer is to make clear something that, if allowed to remain vague or ambiguous, could have led a person into error. Disclaimers had this effect in Butcher where it was held that the effect of reading an entire brochure, including the disclaimers, was to make it clear that the survey report included in the brochure had not been prepared by the producer of the brochure but was simply being passed on without any representations being made as to its truth or falsity. It is apparent that if a disclaimer is to function in this way it must be worded unambiguously, feature prominently and it must be communicated to the reader that the disclaimer is relevant to the information it is seeking to qualify. As Jacobson and Bennett JJ noted in National Exchange [Pty Ltd v Australian Securities and Investments Commission [2004] FCAFC 90 at [55]; (2004) 49 ACSR 369 at 381]: "Where the disparity between the primary statement and the true position is great it is necessary for the maker of the statement to draw the attention of the reader to the true position in the clearest possible way." (emphasis added) 281 Consistently with the clarity and prominence required of a disclaimer to be effective to dispel otherwise misleading conduct, Wilcox J in Hutchence v South Seas Bubble Pty Ltd (1986) 64 ALR 330 observed (at 338) that: There are occasions upon which the effect of otherwise misleading or deceptive conduct may be neutralized by an appropriate disclaimer.... But such cases are likely to be comparatively rare and to be confined to situations in which the court is able to reach satisfaction - the onus resting on the party relying upon the disclaimer - that the disclaimer is likely to be seen and understood by all those - leaving aside isolated exceptions - who would otherwise be misled before they act in relation to the relevant transaction. (emphasis added; citations omitted)

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7.7.3 Neither the stand-alone disclaimer or the terms and conditions of access to the Members' Area erase the misleading, deceptive or false representations 282 The Stand-Alone Disclaimer which appeared at the end of the page entitled "Oops! This Content is Members Only" read as follows: Disclaimer: All information, data, and material contained, presented, or provided on the Homeopathy Plus Website, or within its communications and newsletters, has been sourced from multiple authors and is for general information and education purposes only. The information is not to be construed necessarily as the opinions of the publisher and is not intended to replace from your homeopathic or doctor, or to be a substitute for a consultation with a trusted health care provider. All remedy-related information is drawn from homeopathic pharmacopoeias and materia medicas listed by the Therapeutic Goods Administration (Australia) and referenced worldwide. Serious injury or illness should not be treated without expert advice and we recommend you always seek medical help and diagnosis where appropriate. (emphasis added) 283 Relevantly, the terms and conditions of access to the Members' Area included the following: Homeopathy Plus Website Member Area Terms and Conditions PLEASE READ THESE TERMS AND CONDITIONS CAREFULLY BEFORE ACCESSING THE MEMBER AREA OF THIS SITE By accessing the Member Area you signify your assent to these Terms and Conditions. If you do not agree to all of these Terms and Conditions of use, do not access the Member Area! Homeopathy Plus may revise and update these Terms and Conditions of use at any time. Your continued usage of the Homeopathy Plus Member Area will mean you accept those changes. … The Homeopathy Plus Member Area Does Not Provide Medical Advice The contents of the Member Area, such as text, graphics, images, information and other material contained in the Member Area ("Content") are for informational purposes only. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read in the Homeopathy Plus Member Area! If you think you may have a medical emergency, call your country's emergency number immediately. Reliance on any information provided in the Homeopathy Plus Member Area is solely at your own risk. 284 I do not consider that either the Stand-Alone Disclaimer or disclaimer in the terms and conditions erase the false, misleading or deceptive nature of the information contained in the Second Whooping Cough Article and thereby modifies the conduct. 285 First, neither disclaimer is proximate to the representations or articles in which they are made. They are both in the nature of generic statements that appear on a different page at the point at which a member of the public is presented with the option of signing up for access to the Members Area of the Website. As such, it cannot be said that the relevance of the disclaimers to the representations made in the Second Whooping Cough Article has been effectively communicated to the reader; nor that the disclaimers featured prominently vis-a-vis the false, misleading or deceptive statements. 286 Added to this, the terms and conditions were exceedingly lengthy. The printout of the terms and conditions from the Website spanned some 4 and a half pages in minute font at 1 and a half line spacing. Those terms and conditions addressed many topics including terms and conditions of access to the Member Area, children's privacy, use of the content of the Member Area, the liability of Homeopathy Plus for use of the Member Area and its content, passwords, responsibility of members for blogs on community and member to member areas of the Website and Homeopathy Plus' rights to remove or edit such communications, disclaimer of liability for content of third-party websites to which links are provided, and jurisdiction for disputes with Homeopathy Plus. It seems highly unlikely that any visitor would trawl through these merely to get access to another part of the Website for free, although perhaps the more diligent might skim briefly through them. 287 Secondly, the terms and conditions stated that the information on the Website is "for informational purposes only". Similarly, the Stand-Alone Disclaimer stated that information on the Website "is for general information and education purposes only." As the ACCC submitted, however, this does not modify the fact that the information advanced as to the efficacy of homeoprophylaxis to prevent whooping cough has no foundation in medical science, nor the misleading statements as to the effectiveness or lack thereof of the Vaccine. Indeed, as the ACCC also submitted, "the nature of the disclaimers tends to aggravate the conduct, by suggesting that the statements have informative or educational content." That impression is reinforced in the case of the Stand-Alone disclaimer in stating also that "[a]ll remedy-related information is drawn from homeopathic pharmacopoeias and material medicas listed by the Therapeutic Goods Administration (Australia) and referenced worldwide". 288 Fourthly and most significantly, it cannot be said, in line with the authorities to which I have referred, that the disclaimers clearly bring to the attention of members of the public visiting the Website and reading the Second Whooping Cough Article the true position in clear and unambiguous terms so as to erase the otherwise misleading text. As the ACCC submitted: A disclaimer of this kind would directly qualify the otherwise misleading text. It may comprise an accurate statement concerning the nature and limitations of the evidence base for statements about the efficacy of homeoprophylaxis, a statement concerning the care that should be taken in using homeoprophylaxis for any serious or life-threatening condition such as whooping cough, or something of a similar kind. It does not comprise a standard form disclaimer of the kind included in the Website.

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8.7.1 "in trade or commerce": general principles 289 At all material times, as the ACCC submitted, the phrase "trade or commerce" has been defined in s 4(1) of the CCA to mean as "trade or commerce within Australia or between Australia and places outside Australia". From the time of commencement on 1 January 2011, s 2(1) of the ACL has also contained a definition of "trade or commerce" which adds to the definition in the CCA the words "and includes any business or professional activity (whether or not carried on for profit)" 290 In so providing, the definition in the ACL would appear to have expressly adopted the Full Court's construction of the words "trade or commerce" in the Trade Practices Act 1975 (Cth) (the predecessor Act to the ACL) in Re Ku-ring-gai Co-operative Building Society (No 12) Ltd (1978) 22 ALR 621 ("Ku-ring-gai"). The Court there held that the words "trade or commerce" were words of "the widest import" and were not restricted to activities for the making of a profit. Thus, in Ku-ring-gai, the applicants did not engage in lending moneys for profit or on the open market. Rather, they performed an important social function in making loans at low interest rates to members from moneys ultimately sourced in government funds or with the help of a government guarantee. Deane J (with whom Brennan J (as his Honour then was) relevantly agreed) held at 648-9 that: The common dominant objective of trading and commercial dealings in the market place, namely profit, is lacking from their activities... Their motive for making such loans is to benefit the members to whom they lend. If the scope of the phrase "trade or commerce" in s 47 of the Act were restricted to ordinary trading and commercial activities in open markets, there would plainly be a great deal to be said for the applicants' submission that their lending to their members is not in such trade or commerce. The phrase cannot, however, in my view properly be regarded as so restricted. The terms 'trade' and 'commerce' are not terms of art. They are expressions of fact and terms of common knowledge. While the particular instances that may fall within them will depend upon the varying phases of development of trade, commerce and commercial communication, the terms are clearly of the widest import… They are not restricted to dealings or communications which can properly be described as being at arm's length in the sense that they are within open markets or between strangers or have a dominant objective of profit-making. 291 Thus, his Honour found that, notwithstanding the altruistic character of the applicants' activities, their lending to members was in trade or commerce: at 643. 292 While the words "trade and commerce" are widely construed, the plurality (Mason CJ, Deane, Dawson and Gaudron JJ) in Concrete Constructions (NSW) Pty Ltd v Nelson (1990) 169 CLR 594 ("Concrete Constructions") held that requirement that the conduct be "in" trade or commerce qualifies the prohibition so as to limit it to "'the central conception' of trade or commerce and not to the 'immense field of activities' in which corporations may engage in the course of, or for the purposes of, carrying on some overall trading or commercial business" (at 603). Thus, consistently with Kur-ring-gai, their Honours held at 603-604 that: …the section was not intended to impose, by a side-wind, an overlay of Commonwealth law upon every field of legislative control into which a corporation might stray for the purposes of, or in connection with, carrying on its trading or commercial activities. What the section is concerned with is the conduct of a corporation towards persons, be they consumers or not, with whom it (or those whose interests it represents or is seeking to promote) has or may have dealings in the course of those activities or transactions which, of their nature, bear a trading or commercial character. Such conduct includes, of course, promotional activities in relation to, or for the purposes of, the supply of goods or services to actual or potential consumers, be they identified persons or merely an unidentifiable section of the public. (emphasis added) 293 In Concrete Constructions, for example, a purely internal communication from one employee to another employee in the course of ordinary activities about the construction of a building was held not to constitute conduct "in trade or commerce". That decision in turn was subsequently approved by five members of the High Court (Gleeson CJ, Gummow, Hayne, Heydon and Crennan JJ) in Houghton v Arms (2006) 225 CLR 553 at 565 [33]. 294 As the joint judgment in Concrete Constructions accepted, the dividing line between conduct that is or is not in trade and commerce applying this narrow approach will not always be readily drawn: see also Village Building Company Ltd v Canberra International Airport Pty Ltd (2004) 139 FCR 330 ("Village Building v CIA") at 340 [48]-[49] (the Court). Later cases assist in illuminating the circumstances which will fall on one or the other side of the line. 295 Concrete Constructions was followed in Tobacco Institute of Australia Ltd v Australian Federation of Consumer Organisations Inc (1992) 38 FCR 1 ("Tobacco Institute"). That case concerned an advertisement published in a number of Australian newspapers authorised by the appellant, the Tobacco Institute, on the subject of passive smoking, headed "A message from those who do … to those who don't". The primary judge held that the statement in the advertisement that "…there is little evidence and none which proves scientifically that cigarette smoke causes disease in non-smokers" was misleading and deceptive contrary to then s 52 of the Trade Practices Act 1974 (Cth). While certain aspects of the appeal by the Tobacco Institute to the Full Court were successful, importantly for present purposes the Full Court upheld the primary judge's finding that the relevant statements in the advertisement constituted a breach of then s 52 of the TPA. As Foster J held at 25: The material was… published extensively nation-wide. The advertisement was prominent and eye-catching and described itself as an advertisement. Even the most cursory reading of it would, in my view, have been sufficient to convey to an ordinary reader a message favourable to the consumption of cigarettes as an article of commerce. The advertisement was persuasive in tone. It sought to allay fears which it suggested were commonly and erroneously held that the inhalation of tobacco smoke in the air could be harmful. The name of the appellant, appearing as the authoriser of the advertisement, would, in my view, when coupled with its obvious message, be quite capable of conveying to such a reader that the appellant had a commercial interest in assuaging community concerns about the harmful effects of inhaling environmental tobacco smoke. The general tenor of the advertisement, its wide exposure, and the name of the appellant combined to create an irresistible impression that it was promotional material designed to advance the course of cigarette smoking and to assist in the sale of cigarettes. 296 Similarly, in all of the circumstances, Hill J rejected the appellants' submission that publication was a contribution to a very public debate on passive smoking occurring at the time. Rather, Hill J held at 43-44 that: The advertisement was not intended as a learned contribution to a scientific debate. It was not published in the learned scientific journal. It was directed to the public at large, smokers and non-smokers. It was couched in language designed to persuade, rather than to instruct. It seems highly unlikely that a corporation, lacking a significant commercial interest in the tobacco industry, would have gone to the expense of publishing advertisements in various newspapers of national circulation merely to influence public opinion on a debate of health policy. Rather, it may be inferred, that the corporation which placed the advertisement did so to allay the fears of those who smoked and thus discourage them from quitting and to discourage those who did not smoke from applying pressure on those who did to reduce the occasions on which they smoked, or perhaps give up altogether. In either way the advertisement on its face was designed either to promote the further sale of cigarettes or to arrest a decline in such sales. 297 By contrast, the Full Court in Village Building v CIA held that forecasts of future aircraft noise levels in the vicinity of Canberra Airport published by the Airport in the context of a public debate concerning an application to rezone land south of the Airport and under the flight path as residential, were not made in trade or commerce. The Full Court (French, Sackville and Conti JJ) held that the representations were made by the Airport to members of the public and elected councillors and parliamentarians as part of a campaign to resist the application to rezone the area in question to facilitate residential development. "There was", the Full Court held, "… no relevant trading or commercial relationship between CIA and the persons to whom the representations were made… The representations could not be described as promotional activities designed to persuade consumers to use the services offered at Canberra Airport." (at 342 [51]). 298 The primary judge had characterised the Airport's campaign to revisit the rezoning application as a political activity and therefore held that it was not conduct in trade or commerce. Importantly, the Full Court held (at 342 [54]) that "[t]he two categories are not however necessarily mutually exclusive", explaining further that: There may be activities which are "political" in the sense that they are designed to influence public opinion or achieving a particular regulatory outcome, but which might nonetheless form part of transactions bearing a commercial or trading character (as where a public relations company makes representations to a Minister on behalf of the client). The ultimate question is whether the impugned conduct has the requisite commercial or trading character.

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8.7.2 Were the vaccine representations made in trade or commerce? 299 First, the Respondents contend that Mrs Sheffield's evidence established that the articles were not intended for advertising or marketing but had an advocacy purpose, submitting that: Mrs Sheffield's unambiguous and passionate evidence about the design of the representations is that they were advocating a change in Government policy and not designed to persuade consumers to use the products offered by Homeopathy Plus! Design is left to the consumer and everything to do with the intention of the advocate. Mrs Sheffield gave compelling evidence that she was supremely uninterested in any sales gain that may come of her advocacy efforts. (emphasis in original) 300 Thus the Respondents contend that "Mrs Sheffield's intended purpose was to achieve a different policy outcome regarding the health officials' approach to an epidemic and the commentary was not intended to have a consequence or impact on trading or commercial activities" (emphasis in original). 301 Secondly, the Respondents contend that the design of the Website does not imply that the articles should be considered as made in trade or commerce. In this regard, the Respondents submit that: Much was made as the side-by-side 'shop placement' to the remedies listed in the 'first whooping cough article'. However it does not appear there was any deliberate design to achieve that outcome. Mrs. Sheffield has other people upload articles to the website and design it. The shop sits within an unchanging 'frame' which is not manipulated depending upon the article content of particular page within the website… If the applicant is right, and the presence of the shop necessarily imputes a commercial character to any article sitting within the frame that would mean any article published by 'a sometimes online seller' no matter how political or non-commercial, would attract the jurisdiction of the ACL. The Respondent [sic] submits that this is an untenable and impermissible application of the Concrete Constructions principles (imagine political parties whose media release attracted ACL scrutiny because the Party's website offered badges, T-shirts and bumper stickers bearing the same logos and colour scheme within a tab proximate to the advocacy content). (emphasis in original) 302 In essence, the Respondents' contention is that the articles should be read apart from the 'sidebar' which comprises a permanent frame within which variable content of the Website, including the Articles, is depicted. 303 For these reasons, the Respondents submit that the statements were not made in trade and commerce but were uploaded for information and general educational purposes and constituted participation in, and a contribution to, an ongoing public debate. 304 I reject this submission. In my view, the publication of the Three Articles and making of the Vaccine Representations and Alternative Homeopathic Reasonable Basis Representations, the Respondents engaged in misleading, deceptive or false conduct, and made false or misleading representations, "in trade or commerce" for the purposes of s 18 and 29 of the ACL. 305 First, the question of whether or not the representations were made in trade or commerce does not turn upon whether they were made for the purpose of making a profit, as the definition of "trade or commerce" in s2(1) of the ACL makes clear: see at [289]-[291] above. Equally it must follow that the question of whether or not Mrs Sheffield was interested in any sales gains as a consequence of publishing the articles cannot be determinative of this question. 306 Secondly, in line with Full Court's decision in Village Building v CIA, the fact that an activity may be political in the sense of advocating for a change of policy (or equally, that it is educational) does not necessarily mean that the activity is not in trade or commerce. The question remains whether the impugned conduct has the requisite commercial or trading character. 307 In this regard, I accept that one of the main purposes of Homeopathy Plus is to advocate for homeopathy. Nonetheless, I do not consider for the reasons earlier given at [140]-[141] and [152] and [160] that in the First or Second Whooping Cough Articles, Mrs Sheffield was merely inviting readers to look into the subject further as a part of a wider policy debate, nor that this is what the articles conveyed. Indeed, as I explain further below, it is doubtful whether the evidence established a policy debate about homeoprophylaxis in Australia, at least as an alternative to vaccination. 308 Nonetheless, I accept that the First Whooping Cough article was published in the Treatment Room" of the Website which was intended in part to educate visitors (at [83] above). However, despite the lack of hyperlinks within the text of the article to products available from the Online Shop, I consider that advertising also had a significant role in the inclusion of information uploaded to the treatment room, including the First Whooping Cough Article (at [83]). 309 In this regard, Homeopathy Plus is engaged in the sale of homeopathic products which activity is undertaken by it via the Website: see at [77] above. Moreover, as a director of Homeopathy Plus, Mrs Sheffield has statutory and common law obligations to act in the company's best interests, including to optimise its trading activity: see ss 180-182, Corporations Act 2001 (Cth). She also maintains the Website and uploads material to it, including authoring and uploading the Three Articles. Both Mrs Sheffield and Homeopathy Plus are participants in the relevant trade or commerce, being the supply and promotion of homeopathic products. 310 It is this context - the supply and promotion of homeopathic products - that the representations in question were made. In this regard, contrary to the Respondents' submission, I do not consider that the constant frame within which the First Article was published can be ignored. By a click through menu to the online shop, Drosera could be purchased, being one of the two remedies expressly mentioned in the First Whooping Cough article as a remedy for prevention of whooping cough. Furthermore, as in the Tobacco Institute case, the First Article was directed to the public at large and persuasive in tone. It sought to "debunk" vaccination as an effective means of preventing whooping cough and promote homeopathic remedies including Drosera as a safe and effective alternative. It was partial and was not intended as a learned contribution to a scientific debate, nor published in a learned scientific journal. In this regard, it is simply wrong to say, as do the Respondents, that the First Whooping Cough Article (and Second Whooping Cough Article) appear to be "…an exposition on competing schools of thought regarding the best way to tackle the whooping cough epidemic (the current Governmental approach or the homeopathic approach)." Nor even, was the article published in the "political issues" section of the Website, although even if it had been, I do not consider that I would have reached any different view. Given these features, in my opinion, the tenor of the article, coupled with ready access to the online Shop via the side menu for purchase of Drosera and other remedies, create an irresistible impression that the First Whooping Cough article was promotional material designed at least in part to persuade visitors to consider purchasing Drosera and other homeopathic remedies. The statements were made as part of "the mutual communings, the negotiations verbal and by correspondence, the bargain, the transport and the delivery which comprise commercial arrangements": Ku-Ring-Gai at 139 (Bowen CJ). As such, the representations in the First Whooping Cough Article were plainly made in trade and commerce. 311 Essentially the same features are present in the Second Whooping Cough Article and lead, in my opinion, to the same conclusion. Added to this, the banner at the top of the Website which comprised part of the constant frame within which the Second Article was published, now referred expressly to the "Online Store" and Mrs Sheffield accepted that the online store was one of the three encompassing things for the website (see at [92] above). Nor was there any reference to a separate page for "political issues" in the toolbar. Again, the fact that the article may have been intended at least in part to educate visitors does not detract in my view from the fact that the representations nonetheless bore a trading and commercial character. 312 The Respondents also sought to make much of the fact that the second article poses a question in the title "Whooping Cough - Homeopathic Prevention and Treatment?". That makes no difference in my view as the article then purports to answer the question by advocating for homeopathic prevention and thereby promoting remedies available for sale on the Website, including Drosera which again is expressly referred to as a remedy for the treatment or prevention of whooping cough in the body of the article. 313 I also consider that the Government Article bears a trading and commercial character. While I accept that the article was in part intended to advocate for a change in the government's approach to the epidemic, I also consider that the article promoted the online shop, as I found at [104] above. It seeks also to promote homeopathic remedies in a partial and persuasive tone by inviting the visitor to know about them, having represented that the Vaccine is largely ineffective. I do not consider that the lack of a direct link to the Second Whooping Article mentioning Drosera or to the products themselves changes the character of the Government Article. The article appears within the same frame providing click-through access to the on-line shop and other parts of the Website, including to the Second Whooping Cough Article, together with a search engine, having invited the visitor in effect to seek out more information which the frame indicates can be found within the Website: see at [167] above. 314 The fact that the First and Second Articles do not expressly advertise that the products in question are for sale in the online shop, nor that the Government Article does not expressly mention specific products, does not lead me to any different view. As, for example, Hely J observed in Wool Innovation Network Ltd v Newkirk (No 2) [2005] FCA 1307 at [20], promotional activities may be in trade or commerce "even if they do not specifically refer to the goods or services in question. For example, promotion of BHP as 'the big Australian' might be conduct engaged in trade or commerce." Equally, in Nixon v Slater & Gordon (2000) 175 ALR 15 at 22-23, Merkel J held that the circulation of booklets to medical practitioners providing information about the role of the law firm, Slater & Gordon, was a promotional activity in relation to the potential supply of legal services to clients, notwithstanding that it was not directed at consumers. 315 The Respondents also submitted that, if the Government Article were considered commercial, "the chilling effect of such a finding will make it increasingly difficult for anyone with a good faith alternative view (i.e. outside the prevailing orthodoxy accepted by government health departments) to disseminate information designed to inform that debate from the particular paradigm". However, the argument would seem to be more in the nature of a policy argument rather than to have a legal foundation. In any event, the argument is met by the findings that the Articles made misleading, false or deceptive representations which were intended to promote the sale of particular products. Even if they were also intended to contribute to a policy debate, that does not absolve the makers from a contravention of the ACL. 316 Finally, the evidence establishes the existence of a public debate about the efficacy of homeopathy in the United Kingdom. In this regard, Professor Phelps explained that in the United Kingdom "[t]he debate is at Government level, in terms of funding through the National Health Service.… There is a debate within the medical profession and the medical and non-medical practitioners of homeopathy and, clearly, that spills either into a public debate because through the media the public become aware of debates that are being had at political and professional level and so it becomes a pervasive community debate about efficacy and also government funding." I also accept that within Australia, there is a public debate about the use of homeopathy. Professor Phelps would seem to acknowledge this in her evidence even though she implies that the debate may be less widespread than in the United Kingdom, stating that: There's certainly a lot of questioning of the use of homeopathy in Australia at the moment. It's far less popular in Australia than it is in some other countries, and there are other disciplines within the field of complementary medicine that are considered to be not only more efficacious but more plausible and certainly more popular with the public and with the medical profession. And so the international scene does vary from country to country. 317 However, I do not consider that the evidence supports the existence of any public debate about the use of homeoprophylaxis as an alternative to the vaccination for the prevention of whooping cough or generally. As the ACCC submitted, "the impugned conduct does not reasonably appear to promote or provide a contribution to, public debate concerning a current or proposed law or government policy, or another issue of general concern to the community." Certainly Mrs Sheffield was an advocate and perhaps Dr Golden. However, there was no evidence of any widespread debate about the issue and in particular no evidence any homeopathic representative body considered that this was an issue. To the contrary, the Australian Register of Homeopaths, which is the peak body in Australia, has taken the position that homeoprophylaxis should not be recommended as a substitute for immunisation: see at [266] above.

[30]

CONCLUSION 318 It follows for these reasons that I find the contraventions of ss 18 and 29 of the ACL as alleged by the ACCC to be made out. First, by publishing the Three Articles containing the Vaccine Representations and the Alternative Homeopathy Reasonable Basis Representations, the Respondents engaged in conduct in trade or commerce that was misleading and deceptive, or likely to be so, in contravention of s 18 of the ACL. Furthermore, the Respondents in trade or commence made false or misleading representations that the Vaccine is of a particular standard or quality (essentially short-lived, unreliable and ineffective) contrary to ss 29(1)(a) and (b) of the ACL by publishing the Vaccine representations in the Three Articles when in fact the Vaccine is effective in protecting the significant majority of people exposed to the infection from contracting whooping cough. Finally, the Respondents also in trade or commerce made false or misleading representations in connection with the supply or possible supply of homeopathic products or treatments that these products or treatments have a particular standard or quality, contrary to s 29(1)(a) and (b) of the ACL, and have a use or benefit contrary to s 29(1)(g), namely: that there is an adequate foundation in medical science for the statement that homeopathic treatments are a safe and effective alternative to the Vaccine when no such foundation exists and the Vaccine is the only treatment currently approved for use and accepted by medical practitioners in Australia for the prevention of whooping cough. 319 I intimated at the end of the hearing that, if I should find a contravention, I may leave the terms of the declaratory relief to be matters for the conclusion of the case. However, in the circumstances, the terms of the draft declaratory relief sought by the ACCC simply reflect my findings. This is not a case where my findings would sustain only some, but not all, of the declaratory relief sought and where there may as a result be some room for argument as to how those findings might be reflected in the declarations. For this reason I consider it appropriate to make the declarations now in the terms sought. The parties will be heard on the question of the penalties sought by the ACCC and other final relief sought. I certify that the preceding three hundred and nineteen (319) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Perry.

Parties

Applicant/Plaintiff:

Australian Competition and Consumer Commission

Respondent/Defendant:

Homeopathy Plus! Australia Pty Limited

Legislation Cited (8)

Fair Trading Act 1999(Vic)

Trade Practices Act 1975(Cth)

Trade Practices Act 1974(Cth)

Evidence Act 1995(Cth)

Competition and Consumer Act 2010(Cth)s 6

Corporations Act 2001(Cth)

National Health and Medical Research Council Act 1992(Cth)ss 3(1), 7(1)

Therapeutic Goods Act 1989(Cth)ss 3(1), 4, 19, 19A, 19D(1), 19D(4), 25

Cases Cited (29)

Concrete Constructions (NSW) Pty Ltd v Nelson (1990) 169 CLR 594 Dasreef Pty Limited v Hawchar (2011) 243 CLR 588 Downey v Carlton Hotels Asia Pacific Pty Ltd [2005] QCA 199 Dynamic Lifter Pty Ltd v Incitec Ltd (1994) 30 IPR 198 Given v Pryor (1928) 39 FCR 437 Global Sportsman Pty Ltd v Mirror Newspapers Ltd (1984) 2 FCR 82 Harrington-Smith on behalf of the Wongatha People v Western Australia (No 2) (2003) 130 FCR 424 HG v The Queen (1999) 197 CLR 414 Honeysett v The Queen (2014) 88 ALJR 786 Houghton v Arms (2006) 225 CLR 553 Hutchence v South Seas Bubble Pty Ltd (1986) 64 ALR 330 Nixon v Slater & Gordon (2000) 175 ALR 15 Noone v Operation Smile (Australia) Inc. (2012) VSCA 91 Parkdale Custom Built Furniture Pty Ltd v Puxu Pty Ltd (1982) 149 CLR 191 Re Ku-ring-gai Co-operative Building Society (No 12) Ltd (1978) 22 ALR 621 Taco Company of Australia v Taco Bell Pty Limited (1982) 42 ALR 177 Tobacco Institute of Australia Ltd v Australian Federation of Consumer Organisations Inc (1992) 38 FCR 1 Village Building Company Ltd v Canberra International Airport Pty Ltd (2004) 139 FCR 330 Rose v Health Commission (NSW) (1986) NSWCCR 32 Seafolly Pty Ltd v Madden (2012) 297 ALR 337 Wool Innovation Network Ltd v Newkirk (No 2) [2005] FCA 1307

[2012] AATA 362

(2011) 206 FCR 264

(2013) 250 CLR 640

(2004) 218 CLR 592

Cited By (4)

ALDI Foods Pty Limited as General Partner of ALDI Stores (a Ltd Partnership) v Transport Workers' Union of Australia

Australian Competition and Consumer Commission v Birubi Art Pty Ltd

Australian Competition and Consumer Commission v Homeopathy Plus! Australia Pty Limited

Australian Competition and Consumer Commission v TPG Internet Pty Ltd