Schwabe Pharma (Aust) Pty Ltd v AusPharm.Net.Au Pty Ltd [2006] FCA 868 | Case summary

background 5 The first applicant in the proceeding, Schwabe Pharma (Aust) Pty Ltd, is a wholly owned subsidiary of a German company described as Schwabe International GmbH which is a subsidiary of Dr Willmar Schwabe GmbH & Co KG ('DWSG'). The first applicant carries on business in Australia as the sponsor of a product called Tebonin which is manufactured in Germany by DWSG. 6 The first applicant has responsibility for maintaining and protecting the intellectual property DWSG holds in relation to its Tebonin product and liaising with regulatory authorities in Australia concerning regulatory approvals for the product. The second applicant, Natural Health Products Pty Ltd ('Natural Health'), has been appointed by DWSG as its distributor of Tebonin product in Australia. 7 Tebonin is a therapeutic good for the purposes of the Therapeutic Goods Act 1989 (Cth) and is required to be listed in the Australian Register of Therapeutic Goods ('ARTG') maintained under that Act by the Therapeutic Goods Administration ('TGA') which is a unit of the Australian Government Department of Health and Ageing. On 27 January 2006, a 'Certificate of Medicine Listing' issued to the first applicant by the TGA. The Register contains details of the active ingredient for the product, details of the manufacturer and coded indications of various claims for the product. The 'Listing Record' extracted from the ARTG reveals a therapeutic claim that the product may be taken for 'the symptomatic relief of Tinnitus'. 8 Tinnitus, described as the perception of sound in the absence of external stimuli (commonly described as ringing in the ear), is a common problem which affects 6% to 14% of the general population. Approximately 1% to 2% of the population are severely disturbed by the condition. 9 Various extracts of the plant 'Ginkgo biloba' are thought by some to have therapeutic or medicinal qualities in the treatment of Tinnitus. Dr Willmar Schwabe, a German physician, is said to have identified the essential active compounds in the plant which led to the development of a proprietary concentrated and purified Ginkgo biloba leaf extract known as EGb761. 10 A statement by Dr Robert Hoerr (Exhibit 'JAS17' to the affidavit of John Anthony Sweep sworn 1 June 2006) describes Tebonin (EGb761) and its differentiation in this way: 'Tebonin product (EGb761) is produced by a patented 27 stage process using different solvents for different steps to enrich both the flavones and terpenoids in the finished product at a defined ratio and there is evidence that both these compounds are important for efficacy. The ginkgolic acids, which are toxic, are removed to below the detection thresholds in EGb761. Due to this specific process, EGb761 has a unique chemical composition and a product that is not produced in exactly the same way inevitably differs from it in respect of its chemical composition. That is a really important issue and the difference can be shown eg, by electroencephalography with different products ie that the product composition, the bioavailability and the efficacy will differ. Bioavailability means the active ingredients are available at the site at which they are intended to take effect and so is a prerequisite for efficacy. Even the inactive compounds in a phytopharmaceutical may be important for bioavailability and thus for the efficacy of the active compounds. That is why different extracts of Ginkgo biloba or any other plant extract can never be the same in terms of efficacy and cannot be compared. This is a general principle in phytopharmaceutical medicine.' 11 In April 2006, pharmacies in Australia received a fax notifying them of an advertising campaign to launch Tebonin in the Australian market. On 3 March 2006, Natural Health was appointed as the Australian distributor for the product. Natural Health applied for and obtained from the 'Complimentary Healthcare Council of Australia' ('CHC') approvals for four advertisements promoting the product. 12 AusPharm.Net.Au Pty Ltd was incorporated on 16 June 2004. The third and fourth respondents are the directors of the company. There are 35 'B' class shares all held by Mr Mark Dunn and his partner Ms Rosemary Fisk and 100 issued ordinary shares of which 50 are held by Mr Dunn and Ms Fisk and 50 by Mr Tony Wiss and his wife, Helen Wiss. 13 Exhibit 'JAS28' to the affidavit of John Anthony Sweep sworn 14 June 2006 contains extracts of material printed from the domain name AusPharm.Net.Au which under the heading of the first respondent describes the websites operated by the company in these terms: 'www.auspharm.net.au is in effect three discreet websites (www.auspharm.net.au, www.auspharmacist.net.au and www.auspharmlist.net.au) although to those using the site(s) the three sites appear to be one site.' 14 The three websites have an operational inter-relationship. The AusPharm, AusPharmacist and AusPharmlist websites incorporate direct links to each other's websites in a prominent area at the top of the screen. From the AusPharm website, there is a direct link to the AusPharmacist and AusPharmlist websites. From the AusPharmacist website there is a direct link to AusPharm and AusPharmlist in the tabs at the top of the screen. From the AusPharmlist website there is a direct link to AusPharm and AusPharmacist websites in the dark green panel at the top of the screen. The first respondent also operates a further website described as www.consumerhealthwatch.net.au. The home page for that site is endorsed with the banner and logo 'AusPharm Consumer Health Watch'. From the links page on that website, there is a blue hyperlink to AusPharmacist.Net.Au under the heading 'Resources for Health Professionals'. There are two links from the AusPharmacist website to the AusPharm Consumer Health Watch website. On the AusPharmacist website in the area immediately below the words 'website © Tony Wiss and AusPharm.Net.Au Pty Ltd 1997-2006', and in the area immediately above the words 'website hosted by Red Book Australia and Web Hosting', there is a hyperlink reference described as 'consumerhealthwatch Australia'. There is also a reference to the 'AusPharm Consumer Health Watch' website on the AusPharmlist website. The terms of the hyperlink are 'AusPharm Consumer Health Watch link on AusPharmacist page'. The website www.consumerhealthwatch.net.au has a link to the AusPharmacist website. That link takes the enquirer to the home page for AusPharmacist.Net.Au. That home page exhibits many of the advertisers and sponsors that have taken up advertising packages with the operator of the site, the first respondent. Exhibit 'JAS28' to the affidavit of Mr Sweep sworn 14 June 2006 contains a print out from the AusPharm website by which the first respondent describes the advertising arrangements for the three inter‑connected websites, AusPharm, AusPharmacist and AusPharmlist (but not including www.consumerhealthwatch.net.au). 15 The advertising arrangements are these: 'Each site has a basic external advertising framework surrounding the main content. All pages and sub-pages have the same framework. Advertising options are the same for each of the three sites. Each site has the capacity to feature one banner at the top of the site. These banners must be approximately 400 by 70 pixels in size. The monthly fee to insert a banner is $500 for one site and $1,000 for all three. Each site also has the capacity to accommodate several buttons down the right hand column. These buttons need to be approximately 100 x 100 pixels in size. There are two groups of buttons, the "main" group consisting of the top four or five buttons (depending on the site) and the "secondary" groups all of the rest. The monthly fee to insert a button into the main group is $300 for one site and $600 for all three. For the secondary group the rates are $200 and $400. The exact location of buttons within the groups on each site cycles (automatically) on a daily basis from the top to the bottom. Buttons may be gift, jpg or swf files. AusPharm Job of the week: the AusPharm Job of the Week is available once every two weeks and the charge is $200. Other advertisements can be incorporated directly into the AusPharm(e) News. These ads must be less than 200 Kb in size and must be deemed appropriate for the target audience. For example, cigarette ads wouldn't be allowed. The fee for this service is $100. Display of a logo in AusPharm(e) News is $50 for one day, $200 for a week (five issues) and $500 for a month (20 issues). Further Information Mark Dunn mark@auspharm.net.au' 16 The first respondent by the AusPharm website describes the role of AusPharm in this way: 'It aims to provide pharmacists with all of the latest news and information relating to pharmacy practice in Australia, including links to published media coverage of pharmacy news and feature articles from industry leaders. It consists of a suite of websites incorporating AusPharm, AusPharmlist and AusPharmacist websites'. 17 The AusPharm Consumer Health Watch site is described by the first respondent at the consumerhealthwatch.net.au site in this way: 'AusPharm Consumer Health Watch looks critically at the claims made by non‑prescription health related products in the pharmacy marketplace, assesses the therapeutic claims they make against the existing research, looks at product safety and the value for money, engages in dialogue with the product sponsor and then publishes its findings. Its primary aim is to help consumers make informed choices about these products'. 18 In undertaking a critical examination of such claims, the first respondent describes the 'review process' it says the AusPharm Consumer Health Watch Group will follow, in these terms: 'The group will either identify themselves or have referred to them a "product" that is either already in or about to be launched into the pharmacy marketplace for assessment. Once they receive this they will: Ÿ assess the product's claims against the evidence/literature; Ÿ assess the product's claims against the legislation relating to allowable claims; Ÿ assesses product safety; Ÿ assesses "value for money"; Ÿ produce a draft report; Ÿ refer this report to the product sponsor for comment; Ÿ produce a final report.' 19 The first respondent says the report emanating from the review will be: Ÿ published on the AusPharm Consumer Health Watch website; Ÿ disseminated widely to other media (eg Choice, Today Tonight, A Current Affair, media monitors, newspapers, radio etc); Ÿ forwarded to the Australian Consumer's Association and other consumer groups; Ÿ forwarded to the National Prescribing Service ("NPS"); Ÿ forwarded to Therapeutic Goods Administration ("TGA"), the Therapeutic Goods Advertising Paid Council ("TGACC"), and possibly other government agencies. Ÿ The working group is conscious of the fact that there are countless products in the marketplace that might be the subject of a review. Ÿ The group intends to restrict its focus to those products with higher profiles, eg those with national distribution and promotion.' 20 The AusPharm Consumer Health Watch website describes the composition of the group that will undertake the review process. The group is described as a 'working group' and is made up of the second, third and fourth respondents (Ken Harvey, Mark Dunn and Tony Wiss), Lesley Braun, Meeghan Clay, Kate Doughty, Claire Keith and Greg Kyle. The website describes the background for each member of the group in this way. Mark Dunn is the convenor of AusPharm Consumer Health Watch and a director of the first respondent. Tony Wiss has operated a pharmacy for approximately 20 years and has become involved in the information technology side of pharmacy. He now works as an IT consultant primarily in pharmacy. Tony Wiss is also a director of the first respondent. Lesley Braun is 'a pharmacist, a naturopath with an interest in the evidence based clinical practice of all Healthcare professions, complementary medicine, in particular, rational use and safety issues. She is completing a PhD at RMIT investigating Hospitals and Complementary Medicines with a focus on issues of safety and evidence based practice'. Meeghan Clay is 'a rural pharmacist who has primarily worked in the retail as a pharmacist and manager. She is a medication review consultant pharmacist and has conducted residential and home medication reviews for a number of Aged care facilities and Community pharmacies'. Kate Doughty is 'a newly registered pharmacist who works in community pharmacy. She is particularly interested in evidence base complementary medicines'. Greg Kyle is 'a pharmacist with an interest in professional pharmacy practice and quality use of medicines. He has seen firsthand the confusion that can be caused by marketing of products with a questionable evidence base while managing national consumer medicines information services. Greg is currently undertaking a PhD at the University of Queensland in the quality use of medicines arena'. Claire Keith is 'currently working as a clinical pharmacist at the Austin Hospital in Melbourne. She has a background in drug information, and spent time as an editor at the British National Formulary. As a new challenge in 2006, she has begun studying towards a Masters degree in Public Health'. Ken Harvey is 'a public health physician with a special interest in medicinal drug policy, medicinal drug use and pharmaceutical promotion. He was a member of the WHO team that formulated "Ethical Criteria for Medicinal Drug Promotion" (1988) and has also been a member of the Therapeutic Goods Advertising Code Council (Media Council of Australia). Ken is a member of Health Action International, the Doctor's Reform Society, the Australian Labour Party and the Australian Consumers Association. Apart from submitting complaints about pharmaceutical promotion to Medicines Australia, he has no other association with the pharmaceutical industry'. 21 Both Mark Dunn and Tony Wiss declare on the AusPharm Consumer Health Watch website potential conflicts of interest in being members of the group in that 'the AusPharm publications accept paid advertising from companies who provide goods and services to the pharmacy industry in Australia'. 22 The effect of this material is that a working group of individuals with the background experience reflected in the biographical profiles above have come together for the purpose of conducting critical reviews of non‑prescription health related products. These reviews will be undertaken in accordance with a process which involves an assessment of the claims made for such products against the background of both the evidence in support of those claims and professional and analytical literature relevant to those claims. The process involves a central conception that a draft report will be prepared by the group emanating from the review process as described and that report will be provided to the product sponsor for comment. A final report will then be developed which will be published very extensively not only on the 'AusPharm Consumer Health Watch' website but also through dissemination to major media outlets both electronic and print and to consumer associations and the various regulators. 23 The applicants contend that in undertaking this review the first respondent engaged in misleading and deceptive conduct in contravention of s 52 of the Trade Practices Act and the second, third and fourth respondents were knowingly concerned in the contravention. Further, the applicants contend that the conduct of the respondents involved the publication of injurious falsehoods concerning the applicants. 24 The applicants' evidence is this. 25 On 28 April 2006, Ms Deborah Reddy received a telephone call from Ken Harvey enquiring about the Tebonin product and its use in relation to Tinnitus. Ms Reddy is a registered nurse and customer representative employed by the distributor, Natural Health. Dr Harvey was told that there are over 60 controlled clinical trials of the product. Dr Harvey said he would be interested in seeing the studies as he is a doctor. Ms Reddy said she would contact Schwabe in Germany and see whether any studies could be sent to him. Ms Reddy asked Dr Harvey to provide an email address so the material could be sent directly to him. Dr Harvey gave Ms Reddy an email address at La Trobe University. Ms Reddy expressed surprise that Dr Harvey was at the University. Dr Harvey said he lectured there. Ms Reddy spoke to a director of the first applicant about the request from Dr Harvey. Ms Reddy requested Mr Sahlholt, of the first applicant to provide Dr Harvey with studies pertinent to Tinnitus. Ms Reddy sent Dr Harvey hard copies of two studies she had at hand and available to her. Dr Harvey thanks Ms Reddy for her assistance, that day. 26 On 2 May 2006, Ms Serene Chiang sent by email three papers to Dr Harvey and copied the email to Mr Sahlholt. The three papers were a paper by E Ernst & C Stevinson entitled 'Gingko biloba for Tinnitus: A Review', 22 January 1999; 'Gingko biloba special extract EGb 761 in the treatment of tinnitus aurium (Results of a randomised, double‑blind, placebo‑controlled study)' by Prof C Morgenstern and Dr E Biermann, 1997; and 'The efficacy of Gingko special extract EGb 761 in patients with tinnitus' (C Morgenstern and E Biermann), International Journal or Clinical Pharmacology and Therapeutics, Vol 40 - No. 5/2002. 27 Although there is great contention about whether Dr Harvey received this email from Ms Chiang, for present interlocutory purposes I accept the evidence of the applicants that the email was sent and that the email log confirms the transmission of the three papers. 28 On 10 May 2006, Ms Reddy received an email from Dr Harvey in these terms: 'In response to the information you kindly provided I now attach a draft report written by Consumers Health Watch about this matter. We should [be] happy to receive (and incorporate) any comments that your company might wish to make about this draft report. Our deadline for incorporating our comment is Monday, March 15, 2006. [Plainly, the reference to Monday, March 15 is intended to be a reference to Monday, May 15]. We anticipate publishing the final report on the Consumers Health Watch website on May 18, 2005 [which should be a reference to May 18, 2006]. On behalf of Consumers Health Watch, Dr Ken Harvey Adjunct Senior Research Fellow School of Public Health, La Trobe University' 29 On 8 May 2006, the TGA wrote to the first applicant in relation to the listing of Tebonin in the ARTG and advised that the 'Office of Complementary Medicines' had become aware that there may be regulatory compliance issues in relation to the listed medicine. The TGA required the first applicant as sponsor of the product to provide certain information to the TGA. 30 On 10 May 2006, the first respondent listed the forthcoming review 'Will Tebonin relieve tinnitus?' for publication on the website for 18 May 2006. 31 On 11 May 2006, Mr John Waitzer wrote to Dr Harvey in response to the submission by Dr Harvey to Ms Reddy of the draft report of the AusPharm Consumer Health Watch Group and the proposal to publish a report having provided the applicants with five working days to respond to the draft. Mr Waitzer raised a number of concerns about the draft report including these: (a) The distributor of the Tebonin product, Natural Health, was not, as contended, asked to provide the University with scientific papers to justify the claims for the product. Further, request for material was not conducted in what might be described as the usual manner. (b) The request put to the distributor's service representative, Ms Reddy, was for papers on Tinnitus because of an expressed interest in the product. At no time did Dr Harvey disclose either in the conversation with Ms Reddy or by way of any written communication that Dr Harvey was a member of a group convened to conduct an independent review based upon the evidence and the literature of claims made for the product, Tebonin, with a view to formulating an analytical report written for the purpose of distribution to regulators, consumers' associations, electronic and media outlets and publication on particular websites. (c) The papers sent to Dr Harvey were not sent for the purpose of verifying in the context of such a review, the efficacy of the product in the therapeutic treatment of Tinnitus. The papers were supplied in response to an academic interest not for the purpose of a formal structural review of product efficacy. (d) Criticisms were made of the views expressed by Dr Harvey in the draft report of the quality and authority of the reports/papers sent to Dr Harvey. Further criticisms were made of inaccurate references in the draft report to papers sent to Dr Harvey. Mr Waitzer was critical that the report made reference to studies which were not sent by Schwabe to Dr Harvey although the draft contended that the source of particular reports was Schwabe. (e) Mr Waitzer was critical of the draft report in not making proper reference to the three papers sent to Dr Harvey by Ms Chiang. (f) Mr Waitzer was critical of the process in that the applicants and DWSG had not been provided with a proper opportunity to respond to the draft report. Mr Waitzer drew attention to the proximity of the timing between the events in late April, the preparation and issuing of a draft report on 10 May 2006 and a letter received by the first applicant from the TGA on 8 May 2006 calling into question aspects of the claims made for the product in relation to Tinnitus. Mr Waitzer drew an inference that Dr Harvey or members of the working group must have been in communication with the TGA and provoked the letter from the TGA notwithstanding that the process contemplated an opportunity being afforded to the sponsor and presumably DWSG to deal with any critical opinion from the working group, before dissemination of that opinion. 32 On 12 May 2006, Mr Waitzer wrote again to Dr Harvey pressing aspects of the concerns reflected in the letter of 11 May 2006. 33 On 12 May 2006, Dr Harvey responded and advised that Mr Waitzer's letter of 11 May 2006 had been circulated to the working group and the letter was under discussion and advice would be taken. Dr Harvey said that his draft reply on behalf of the group would be sent to Mr Waitzer shortly after 15 May 2006. Dr Harvey also said 'We will then send a copy of your correspondence and our response to Dr Peter Bird, Manager, Post Market Review Section, Office of Complementary Medicines, Therapeutic Goods Administration'. 34 Further, on 12 May 2006, Dr Harvey sent an email to Mr Waitzer contending that he had no record of receiving the three papers sent by email on 2 May 2006 by Ms Serene Chiang. Dr Harvey requested Mr Waitzer to resend those three papers and the papers would be taken into account in formulating the final report. On Monday, 15 May 2006, Serene Chiang resent the three papers and copied that email to Mr Sahlholt. On 15 May 2006, Dr Harvey acknowledged receipt of those three papers. 35 On 15 May 2006, Mr Waitzer wrote to Dr Harvey. Mr Waitzer again pressed what he perceived to be the anomaly that Dr Harvey had not received the three papers sent on 2 May 2006 and pressed the position that the three papers, in any event, had been sent in the context of an expressed interest but not for the purpose of a systemic independent review. On 16 May 2006, Dr Harvey responded advising that a consolidated response to the earlier correspondence would be given. Dr Harvey provided further references to papers by reviewers of the efficacy of Gingko biloba in relation to indicia of Tinnitus. 36 On 16 May 2006, Dr Harvey expressed comments in an email about the three papers the subject of the earlier issue. Also, on 16 May 2006, Mr Waitzer sent an email to Dr Harvey confirming that the applicants would be given a further seven working days from the date of the response of Dr Harvey to the letters of concern, to respond. On 17 May 2006, Dr Harvey extended the time for a response required by the working group to 5.00pm, 25 May 2006. Dr Harvey observed 'This should provide you with adequate time to produce additional evidence that may change our opinion about the efficacy of Tebonin, EGb 761 (Gingko biloba) for the relief of tinnitus'. That email attached a letter of response to the first applicant's letters of 11, 12 and 15 May 2006. 37 In that response, Dr Harvey dealt with the claim by Mr Waitzer that Dr Harvey had neither articulated to Ms Reddy nor set out in correspondence to the company, the precise role Dr Harvey played, the task he had in mind and the scope of the consequences of the working group formulating its view of the efficacy of the product arising out of its process of review. Dr Harvey said in his response, 'I believe that when a registered medical practitioner, academic, or other qualified health professional asks a product sponsor (or distributor) for information relating to claims made about that product, he or she is clearly proposing to undertake a "legitimate review" of that product'. 38 It seems to me, having regard to the stated purpose of such a review and the methodology the working group represented it would undertake in conducting a review, a failure to properly describe and identify the purpose for which the papers were sought and the task and scope of the role proposed to be undertaken, was misleading. It plainly led Ms Reddy into a false understanding of the purpose for which the reports were sought. An oral request simply on the basis that Dr Harvey was a doctor and an academic at an Australian university made to a customer service representative of the distributor of the kind made by Dr Harvey does not represent a transparent identification of a proposal to undertake what purports to be a comprehensive review, independently, of the efficacy of the product both by reference to the evidence and the literature. 39 Dr Harvey disputes the receipt of the three papers sent by Ms Chiang on 2 May 2006. 40 Dr Harvey contests the proposition that the review process was not undertaken consistent with the published representations of the methodology to be applied. What emerges from Dr Harvey's letter on behalf of the working group in response to the apparent anomaly that on 8 May 2006 the sponsor received a notice from the TGA, at a time contemporaneous with the enquiries made by Dr Harvey and the production of the draft report, is this: '4. You allege that we did not follow our published review process because: 4.1 Our draft report mentioned that we had been in contact with the TGA before you had been given an opportunity to respond to the draft. In fact, our draft report said, "the Therapeutic Goods Administration (TGA) was approached to determine what claims for Tebonin were listed on the Australian Register of Therapeutic Goods and whether these claims had been submitted to independent verification. This (and subsequent communication) with the TGA was undertaken to check TGA procedural matters which we refer to in our report. 4.2 You received a letter from the TGA relating to Tebonin on May 8, 2006 before we sent you our draft report for comment on May 10, 2006. An E-mailed copy of our draft report was sent to you for comment via Ms Reddy at 9.35am on May 10, 2006. A copy was E-mailed to the TGA at 9.55am on the same day. The purpose of sending a copy of the TGA was to afford them the same courtesy we had afforded you; to comment on relevant sections of the draft report in order to ensure our final report is accurate. …" 41 The immediate problem emerging from that response is that the working group sent the draft report to the TGA at the same time the report was sent to the applicants. The review methodology plainly contemplated that the review conducted by the working group would result in the preparation of a draft report which would be provided to the sponsor (and presumably through the sponsor to DWSG); the sponsor would be provided with a reasonable opportunity to respond to the draft report; the response would be properly considered by the working group; a final report would be produced and that report would be the subject of the threatened or proposed publication or distribution. However, Dr Harvey published the draft report absent any response from the sponsor or DWSG, to the Unit of Administration of the Australian Government charged with the regulation of the Therapeutic Goods Act 1989, namely, the TGA. The immediate distribution of the draft to the regulator failed to provide the sponsor or DWSG with any opportunity to put its position and influence the measured, balanced and proportional evaluation of the evidence and the literature leading to a final report. The failure to act consistently with the expressed methodology for the review raises a prima facie case of a contravention of s 52 of the Trade Practices Act. 42 Moreover, the draft report was not only distributed to the regulator but was also sent, without the benefit of a response from the sponsor or DWSG to the draft report, to Mr Craig Patterson, the Manager of the New Drugs Program ('NPS') and the Australian Consumers Association. 43 It seems to me that the distribution of the draft report without compliance with the opportunity for a response to the draft is misleading conduct which has given rise to a distributed report (in draft) containing opinions which may have been properly the subject of further evaluation had the first applicant and DWSG been provided with a proper opportunity to respond and a reasonable time to respond. The notion that the TGA regulations require sponsors of listed medicines to hold evidence in support of the claims made for a product is not an answer to a failure to properly disclose the scope of a proposed independent review of both the evidence and the literature relating to a product. The nature, scope and extent of material going to the evidence in support of claims for a product and the field of literature which might be provided to a group of experts or a working group of consumer health professionals for the purpose of a systemic review of both the evidence and the literature is very likely to be entirely different to the body of material immediately available to a sponsor in support of an enquiry concerning the therapeutic claims for a product. For example, it was precisely that enquiry which Dr Harvey made of Ms Reddy which produced two reports on 28 April 2006 and by 2 May 2006 three reports from Ms Chiang. 44 The distribution of a draft report before any opportunity was afforded to the sponsor to respond is consistent with the comment by Dr Harvey in the email at [33] in which Dr Harvey said he proposed to copy his letter of response of 17 May 2006 to Dr Bird. 45 On 17 May 2006, Dr Harvey sent further material to Mr Waitzer for confirmation of certain matters. 46 On 18 May 2006, Dr Harvey sent Mr Waitzer a further email in these terms: 'During our recent telephone conversation about this matter, you stated that approval for your Tebonin print advertisements (attached) had been obtained from the Advertising Services Office Complementary Council (CHC) of Australia. I have subsequently made contact with the CHC about this matter and they refuse to confirm (or deny) that such an application was made by your company or that "pre‑clearance" of the attached advertisement was made by their Advertising Services Office. They mentioned that pre‑clearance numbers appearing on such print advertisements are sometimes forged. It would be most helpful if you could provide documentation that would substantiate your claim that the attached advertisement was "pre‑cleared" by the Australian Advertising Services Office of the Complementary Healthcare Council (CHC) of Australia.' 47 This notion of Dr Harvey's that the sponsor may have improperly and fraudulently endorsed print advertisements with pre‑clearance numbers which were not obtained was pressed again in an email by Dr Harvey to the administrator of the publisher of a publication called 'Good Health News'. Dr Harvey said this: 'I note that on page 2 of your latest publication, "Good Health News" (May 2000, Issue No. 23) [which presumably is intended to mean May 2006, Issue No. 23] you run an article apparently authored by Christine Sands about the product Tebonin (Gingko biloba). … 2.2 Do the letters and number appearing in the lower right corner of the advertisement CHC35569-03/06 represent an official "pre‑clearance" number by the Advertising Services Office of the Complementary Healthcare Council (CHC) of Australia or is number this a forgery? [presumably the question is - or is this number a forgery?]' 48 Mr David Johnston responded and directed Dr Harvey to the sponsor and said in an email on 27 May 2006: 'All of the contributors to Good Health News who are known to us are entitled to the usual presumption conferred by law that they are acting lawfully and doing things by lawful means. On that basis, we would not normally check a CHC clearance number and would assume it is correct and being used correctly and not "forged" (although not sure exactly what that would mean in this context). If you have any information to the contrary, please supply us with full particulars and you will no doubt also be contacting the CHC Advertising Services Office with those same details.' 49 On 19 May 2006, Dr Harvey sent an email to Dr Tony Lewis the Executive Director of the Complementary Healthcare Council of Australia in which he pressed for a statement as to whether printed advertisements lodged by the sponsor had been pre‑cleared by the Advertising Services Office of the CHC. Dr Harvey said this: 'Having obtained a magnifying glass I am able to ascertain that the letters and number appearing in the lower right corner of the advertisement copied as Appendix IV of our report is as follows: "CHC35569-03/06" Could you please tell us if this is an "official" pre‑clearance number appropriately issued by your Advertising Services Office or a forgery?' 50 Dr Lewis had taken the position that the question of the issuing of pre‑clearances by the CHC was a confidential matter as between the party lodging the advertisement for approval and the CHC. Dr Harvey took objection to the refusal to provide confirmation of whether an approval had been given. At the time Dr Harvey was pressing this matter with the CHC, sending emails to the publisher of Good Health News and copying emails to third parties, there was no basis for suggesting or inferring that the sponsor had fraudulently or unlawfully endorsed advertisements with numbers purporting to represent pre‑clearance numbers. 51 On 21 May 2006, Dr Lewis wrote to the solicitors for the first applicant explaining the conversations with Dr Harvey. Dr Lewis said this: 'He (Dr Harvey) asked me again whether the CHC had approved the advertisement referred to because it had a CHC approval on it. I told him that I would neither confirm nor deny that the CHC had approved the advertisement nor would I provide the other details he had requested. In response to a question from Ken I said that I did not know whether a number appearing on any particular advertisement was a correct number or not. I told Ken that while I did not have ready access to this information there was a system to record approvals. I went on to tell him that if he had information which caused him to believe that any particular advertisement was not approved or if he believed that the claims were not justified he should make a complaint to the Complaints Resolution Panel (CRP). Ken indicated that he was already aware of the complaints process. In referring to my knowledge as to whether an advertising approval number was correct or not, I did not refer to this specific advertisement nor did I use the term "forged" which subsequently appeared in correspondence which Ken sent to Mr John Waitzer of Schwabe Pharma Australia that same day in which he referred to contact with the CHC. Ken said that advertising for Tebonin did not comply with the Therapeutic Goods Advertising Code. I told him that the CRP was the body to rule on this and the organisations that breached the code were potentially subject to substantial financial penalties. He stated that the product carried risk and that it did not work. He referred me to a draft report he had earlier forwarded to Trisha Campbell (CHC) which he said showed it did not work. I put to him the proposition that this was a matter of his believing [Dr Lewis's emphasis] the product did not work. At that point Ken abruptly terminated the conversation.' 52 On 23 May 2006, Dr Lewis sent an email to Dr Harvey which said, in part, this: 'You state in your email below that I mentioned in our telephone conversation that "pre‑clearance numbers appearing on such print advertisements are sometimes forged". This is not what I said. What I said was that I did not know whether the number you had given to me was a correct number for the advertisement you were referring to. I then said that it would be possible for an incorrect number to appear in an advertisement. In saying that, I did not refer to this specific advertisement nor did I use the term "forge". That is entirely your construct.' [emphasis added] 53 Dr Harvey has filed an affidavit in the proceeding in which he denies this construct. Dr Harvey says that neither he nor Tony Lewis suggested that the applicants had in fact forged or used incorrect or unauthorised approval numbers in relation to particular advertisements. However, the evidence suggests a prima facie case of Dr Harvey engaging in communications with parties both at the level of the CHC and third parties on a footing that suggests that numbers endorsed by the sponsor on print advertisements may legitimately give rise to the notion that those numbers were forged and fraudulently applied to the advertisements to convey the impression that the advertisements were authorised when they were not. 54 Correspondence subsequently took place between the solicitors for the applicants and the solicitors for the respondents concerning aspects of the formulation of the draft report and the proposal to publish a final report. A final report was published by Mark Dunn on 9 June 2006 to Dr Peter Bird, Office of Complementary Medicines of the TGA, Mr Craig Davies, TGA Advertising and Export Section and Dr Tony Lewis, Complaints Resolution Committee, Complementary Healthcare Council. 55 The final report is the emanation of a document based upon the draft report and a consideration of the papers sent by Ms Chiang to Dr Harvey and a consideration of the propositions put to Dr Harvey by Mr Waitzer in relation to the draft report and particularly the inadequacies in the process and other matters. It seems to me that there is a serious question to be tried that the final report is affected by the misleading conduct of failing to provide the draft report to the sponsor and DWSG for comment and response before distribution to the parties who received it. In addition, the final report at pages 4 and 5 contains a description of the process of the investigation and it could not be fairly said that the description under the heading "Our Investigation" represents an accurate synopsis of the sequence of events. The language of that part of the report suggests that the sponsor was provided with a reasonable opportunity to respond, it provided no further information and engaged legal representatives to seek undertakings not to publish any criticism of the Tebonin product. The position, of course, is that the sponsor was putting the proposition that the draft report emerged in circumstances where there had been a failure in the central process of the investigation and in circumstances where the very nature of a review by reference to the evidence in support of the claims for the product and the literature relating to the product, had not been disclosed to the sponsor from the outset. 56 A further difficulty with the final report is that in discussing the product Tebonin, there is a conjunction of the term Tebonin and Gingko biloba. The report does not make entirely clear which studies relate to an analysis of the therapeutic affects of Gingko biloba and those which deal quite specifically with the constituent element of the applicants' product described as EGb 761. At page 6 of the final report, the working group says, 'We dispute that Tebonin (Schwabe extract EGb 761) is sufficiently different from other standardised extracts to invalidate the clinical trial evidence we have assessed'. The authors then say that they understand that Gingko biloba extracts must meet the requirements of the 1994 German Commission E Monograph which specifies what the extract must contain. The authors appear not to have taken into account any further the question of whether the processes described by Dr Robert Hoerr [10] provide a basis for a legitimate differentiation between the applicants' form of a product containing an active ingredient derived from Gingko biloba and other products derived from the plant. 57 The final report also talks in terms of the working group providing seven more working days to the product sponsor to provide additional scientific evidence that might 'change our opinion about the efficacy of the product'. These statements are consistent with the notion that the working group had already formed an opinion by the draft document and that that opinion had been circulated. The issue for the sponsor was not whether it could change the opinion of the working group but whether the working group remained in a process of evaluation and proportional consideration of all material until a final view was formed. Moreover, the report refers, as does the early material, to the provision of the draft to the sponsor 'as a courtesy' just as the draft report had been provided to regulatory authorities and consumer associations 'as a courtesy'. The report, of course, could not be provided as a matter of courtesy because the process expressly contemplated that a draft report would be provided for appraisal, comment and response before a final report or final view was formed. That part of the process was integral to a proper review process. Similarly, there could be no courtesy in extending determinative conclusions in draft form to regulatory bodies. 58 The applicants make a further challenge to the report on the basis that the process undertaken by the working group does not reflect a systemic peer reviewed process by reference to evidence and literature consistent with the orthodoxy of such review processes. Dr Hoerr in his statement of 25 May 2006 being Exhibit 'JAS17' of the affidavit of Mr Sweep sworn 1 June 2006 is critical of the methodology and says that it does not provide a foundation for a proper evidence based and literature based review of the efficacy of the product and further, the reviewers failed to recognise the features and processes of differentiation between EGb 761 and generic Gingko biloba extracts. 59 The applicants seek to rely upon a further affidavit from Mr Sweep sworn 16 June 2006 which exhibits ('JAS37') a further report from Dr Hoerr. The respondents object to the admissibility of the affidavit on the basis that counsel for the respondents was provided with the commentary on the morning of the hearing and was not in a position to respond to it. I propose to admit the affidavit although for the purposes of these proceedings I have not had regard to the further statement of Dr Hoerr as the respondents have not had an opportunity to respond to that document. 60 In order to arrest the possible publication of the final report on the AusPharm Consumer Health Watch website and publication otherwise, on the ground that such publication involved the contravention of s 52 of the Trade Practices Act, the solicitors for the applicants sought certain undertakings from the respondents and on 19 May 2006 the solicitor for the applicants wrote to the first respondent and to Dr Ken Harvey, Mr Mark Dunn and Mr Tony Wiss putting each of those parties on notice that the conduct of publishing the report would involve contraventions of s 52 of the Trade Practices Act. Any publication of the report subsequent to notice of the matters complained of, would involve the second, third and fourth respondents being knowingly concerned in a contravention of the Trade Practices Act. 61 In expressing these observations on the facts, I am, of course, not making findings or determinations of contested questions of fact. I acknowledge that the respondents contest the evidence of the applicants. However, an assessment of the evidence of the applicants, recognising that the factual matters are in issue, is made for the purpose of determining whether there is a serious question to be tried as to whether the formulation and publication of the report constitutes conduct in contravention of s 52 or the publication of an injurious falsehood concerning the applicants. 62 I am satisfied that there is a serious question to be tried at the very least and in my view there is a reasonably strong prima facie case of a failure to afford the represented procedural requirement identified by the working group in the conduct of the proposed review. I am further satisfied that the conduct in relation to the agitation of the question of whether the sponsor had potentially engaged in fraudulent conduct by endorsing print advertisements with numbers which may not have reflected approval numbers is also misleading conduct. 63 The questions of law are these. Have the applicants established the necessary burden on the facts of a serious question to be tried. I have expressed a view that the applicants have established a prima facie case of a contravention of s 52 as to that aspect of the case which involves whether the conduct is misleading. In forming that view I have had regard to the observations of his Honour Mason A‑CJ in Castlemaine Tooheys Ltd v South Australia (1986) 161 CLR 148 at 153 in these terms, '(1) that there is a serious question to be tried or that the plaintiff has made out a prima facie case, in the sense that if the evidence remains as it is there is a probability that at the trial of the action the plaintiff will be held entitled to relief; (2) that he will suffer irreparable injury for which damages will not be an adequate compensation unless an injunction is granted; and (3) that the balance of convenience favours the granting of an injunction' or, the applicant must 'be able to show sufficient colour of right to the final relief in aid of which interlocutory relief is sought'. See also Gleeson CJ, Australian Broadcasting Corporation v Lenah Game Meats Pty Ltd [2001] 208 CLR 119 at 217. 64 I will return to aspects of propositions two and three of his Honour's remarks in Castlemaine Tooheys Ltd v South Australia (supra) shortly. 65 The respondents contend that the observations made by Dr Harvey and the working group are merely expressions of opinion that convey nothing more than that the working group honestly held the opinions reflected in the report. See James v Australia & New Zealand Banking Group Ltd (1986) 64 ALR 347 at 372; Global Sportsman Pty Ltd v Mirror Newspapers (1984) 2 FCR 82 at 88; Tobacco Institute of Australia v Australian Federation of Consumer Organisations Inc. (1992) 38 FCR 1 at 25-26 and 45-48. The respondents contend that the expression of opinion may constitute misleading or deceptive conduct but cannot do so if the authors of the opinion genuinely hold the opinion in question and there is some proper foundation for it. See the authorities referred to by Weinberg J at [124], Orion Pet Products v RSPCA (2002) 120 FCR 191 at 213. Dr Harvey says he genuinely holds the opinion reflected in the final report. In this case, both the draft report and final report are affected by misleading conduct in relation to the process adopted for the conduct of the review and thus the basis or foundation for the expression of the opinion. Further, the conduct in relation to the notion that 'pre‑clearance' approval numbers endorsed on print advertisements may not have been genuine, is misleading and deceptive. 66 A further aspect of the applicants' case is that the conduct of the first respondent and conduct in which the second, third and fourth respondents are knowingly engaged is not conduct which occurred 'in' trade or commerce. In some senses, it might be contended that the conduct occurred in connection with or in relation to conduct in trade or commerce but the conduct of convening a working group and conducting an examination of the therapeutic claims of a product in circumstances where the primary author of the report, Dr Harvey, was not paid for the report and the report is to be published upon a website which does not attract any subscription fee for access to a document or commercial sponsorship, fails to engage any aspect of commercial activity. Therefore, the conduct of the working group and the formulation and publication of the draft report and final report is simply a process of intellectual discourse by engaged citizens relevantly skilled in the art with a view to forming a professional opinion. The nature of the democracy is such that individuals are entitled to express an opinion and, particularly, people skilled in the relevant art are free to form views and express opinions about matters such as the veracity of claims for therapeutic benefits of complementary medicines. It may be that the opinion expressed by the working group or any particular individual is right or wrong. Other opinions may be based on greater experience, a greater depth of skill and expertise, a greater degree of focus on the particular expertise which needs to be called upon such as the efficacy of blind trials and other things. The issue is not whether the opinion is correct. It is simply an opinion. It carries no greater weight than the intellectual authority and experience of the author(s). Minds might legitimately differ about a range of matters affecting, for example, the opinions reflected in the report in this case. 67 The difficulties in this case are the ones I have already mentioned as to the question of whether the process was undertaken consistently with the representations made as to the process and other matters. In the absence of that process, the foundation for the opinion as an independent opinion derived from the process as represented, fails. On the question of whether that conduct occurred in trade or commerce, the respondents rely upon the well known passage of their Honours, Mason CJ, Deane, Dawson and Gaudron JJ in Concrete Constructions (NSW) Pty Ltd v Nelson (1990) 169 CLR 594 at 602-604 to the effect that the conduct, the subject of enquiry, must have occurred in trade or commerce thus giving the operation of s 52 a restricted operation. The concept is narrow in the sense that the proscription applies only to conduct which is itself an aspect or element of activities or transactions which, of their nature, bear a trading or commercial character. In Hearn v O'Rourke [2003] FCAFC 78, Dowsett J observed that this construction of s 52 derived from their Honours' observations in Concrete Constructions (supra) reflects the following construct: 'It demonstrates that the focus must be upon the conduct in question and not upon the range of activities in which a relevant corporation may be engaged. In other words, one does not simply identify the conduct in question, note that the relevant corporation is engaged in commercial activity of some kind and then look to a connection between the two. Because corporations are usually formed to engage in commercial activities, it will rarely be difficult to find such a connection. The correct approach is to determine whether or not the relevant conduct can, according to ordinary usage, be described as having occurred in the course of dealings "which, of their nature, bear a trading or commercial character". The commercial undertakings of the corporation in question may be relevant to the exercise. However, the more important question will be whether the conduct is of a kind which is usually of a commercial nature.' 68 Their Honours Finn and Jacobson JJ while not disagreeing with the expressions of principle by Dowsett J derived from Concrete Constructions (supra) took the view that an important element of the observations of their Honours in Concrete Constructions (supra) involved this passage (at 604): '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 customers, be they identified persons or merely an unidentifiable section of the public. In some areas, the dividing line between what is and what is not conduct "in trade or commerce" may be less clear and may require the identification of what imports a trading or commercial character to an activity which is not, without more, of that character.' 69 Their Honours took the view that the impugned conduct, in order to bear the character of conduct 'in trade or commerce' had to occur in dealings undertaken in the course of an activity which of its nature bears a trading or commercial character. In the particular case in question, representations made by a film producer that young teenage Aboriginal girls would be the subject of a documentary film concerning their participation in a contest called the Miss Maid Contest but who were subjected to questioning concerning aspects of their sexual activity, was found to be conduct capable of bearing the description of conduct 'central to the trading or commercial activity of producing a film for profit' and thus conduct in trade or commerce. 70 The respondents say that the principle that the activity in question must bear the character of a trading or commercial activity divorced from other considerations of the activity of the particular corporation is a principle which has been applied in the Federal Court frequently. See Unilan Holdings Pty Ltd v Kerin (1992) 35 FCR 272 per Hill J; Fasold v Roberts (1997) 70 FCR 489; Plimer v Roberts (1997) 80 FCR 303; Robin Pty Ltd v Canberra International Airport Pty Ltd (1999) 179 ALR 449 and Tobacco Institute of Australia Limited v Australian Federation of Consumer Organisations Inc. (1992) 38 FCR 1. 71 Mr Mark Dunn has sworn an affidavit in the proceedings in which he describes the formation of the AusPharm Consumer Health Watch Group ('ACHW'). Mr Dunn says that in early 2006 as a result of concern for the manner in which information about some non‑prescription pharmacy products was being presented to the public, a group of people including Mark Dunn, Tony Wiss and Dr Ken Harvey formed a non‑profit organisation, ACHW, and set up a website to publish articles to the public. Initially there were 10 members of the ACHW Group. Now, seven members have resigned and the group is comprised of Mark Dunn, Dr Ken Harvey and Tony Wiss. Mark Dunn says that as a non‑profit entity, ACHW's primary aim is to inform the public so that consumers can make informed decisions about products. The three remaining members are volunteers and receive no payment in any form for their work. The ACHW website does not carry advertising material and receives no income. Mark Dunn says the costs associated with setting up the website were paid by him and Tony Wiss. The ACHW website is a separate site from the first respondent's other sites. Mark Dunn says the article (report) was written following a consultative process among the group members. 72 The question to be determined on an interlocutory application is whether there is a serious question to be tried as to whether the conduct occurred 'in trade or commerce'. The first respondent operates four websites. The first three websites, AusPharm, AusPharmacist and AusPharmlist are interconnected websites which have the appearance of a single website. The AusPharm website contains a significant number of sponsorship and other commercial endorsements which are productive of revenue. Plainly, there is a trading or commercial activity undertaken by the first respondent in respect of those three websites. The fourth website, sponsored by the first respondent but dedicated to the AusPharm Consumer Health Watch objectives contains a link to the AusPharmacist site which takes the enquirer directly to the home page which displays the substantial field of sponsors and commercial parties. The third and fourth respondents are directors of the first respondent and are therefore directly involved in the sponsorship of the fourth website upon which the report would be published. Because the AusPharm Consumer Health Watch website contains a link to the home page for the primary apparent AusPharm 3-in-1 site [13] it seems to me that there is a sufficient relationship on an interlocutory basis to conclude that there is a serious question to be tried as to whether the conduct is in trade or commerce. 73 In addition, an examination of the materials in evidence from the AusPharm website and its inter‑relationship with AusPharmacist and AusPharmlist demonstrates that the economic methodology for sustaining the services provided by the three inter‑related sites is to secure revenues from commercial participants on any one of the bases identified in the advertising terms and conditions [15]. It seems open, on an interlocutory basis, to infer that the probability is that a similar sponsorship methodology will be applied to the fourth site operated or sponsored by the first respondent even though it may not be the case that there is any demonstrated discreet commercial arrangement between the operator of the site and a commercial party at present. 74 Further, the position in Fasold v Roberts (supra) and Plimer v Roberts (supra) is not directly applicable on the facts of the present case. In this case, two members of the working group, the third and fourth respondents who are authors of the report with Dr Harvey, are shareholders and directors of the company sponsoring the site. In the Full Court in Plimer v Roberts (supra), their Honours took the view that because Dr Roberts was simply an invited expert speaker and had no connection or engagement with the sponsoring body promoting the address, his conduct could not be regarded as conduct in trade or commerce. In this case, the third and fourth respondents are directly involved both as directors and equity holders in the sponsoring vehicle and Dr Harvey together with the third and fourth respondents are members, and core members, of the AusPharm Consumer Health Watch Group. It seems to me therefore there is a greater proximity of connection in the central activity and it bears a sufficient relationship with the other activities of the first respondent that the conduct in question 'of its nature, bears a trading or commercial character'. The question in issue is whether the applicants have established sufficient evidence to raise a serious question to be tried as to whether the conduct is in trade or commerce. I am satisfied that there is a serious question on that issue which ought to go to trial. 75 As to the second aspect of the observations of his Honour Mason A‑CJ in Castlemaine Tooheys Ltd v South Australia (supra), I am satisfied that publication of the report in the manner contemplated by the website, that is, publication on the website and distribution of the document to all of those outlets discussed in these reasons [19], has the potential to cause injury to the applicants which will be both difficult to identify and difficult to compensate by way of damages. 76 As to the third element, I am satisfied that the balance of convenience favours the applicants. It seems to me that there is a significant public interest in allowing the process invoked by the respondents to take its course in the regulatory forums in which they have made their complaint. The Parliament of the Commonwealth has enacted the Therapeutic Goods Act 1989 which provides a regulatory mechanism for dealing with the listing of complementary medicines, prescriptions and offences concerning false representations and false claims of therapeutic benefit for a product and mechanisms which enable the TGA to test whether the sponsor or manufacturer has complied with the Act or engaged in any contravention of the legislation. The respondents elected to publish both the draft and final report to the bodies described at [54]. The Therapeutic Goods Act 1989 is important legislation of the Commonwealth. It seems to me that the public interest is served by enabling the respondents to articulate their criticisms before the relevant officers of the regulatory authorities which in turn will provide a balanced and proportional opportunity for the applicants to respond and put before a relevant decision‑maker the body of data, evidence and material which either supports or fails to support the claims of efficacy for the product. That process should take its course. As an aspect of the balance of convenience, it seems to me that the complaints made by the respondents to the various bodies should take their course free of pre‑judgment by the distribution by the respondents, in the manner suggested in the website material, of their own view of the material. Mark Dunn says in his affidavit that if an interlocutory injunction is granted, it will have the result of stifling public discussion and scientific debate about Tebonin. Debate within the scientific community can take place in circumstances where the matters debated involve a genuinely held opinion about which there is a proper foundation. Having regard to the Therapeutic Goods Act 1989, its purposes and the processes invoked within the forums contemplated by that Act, an examination can occur concerning the claims made for and criticisms of Tebonin. 77 I have also had regard on the balance of convenience to the affidavits of Lauren Rignall sworn 29 May 2006 and 13 June 2006. I am satisfied that the scope of the financial risk which will be difficult to calculate is significant. 78 One further matter the applicants agitate is the assertion that the conduct on the part of the respondents constitutes an injurious falsehood. I am not satisfied that the evidence demonstrates that the conduct in relation to the report reveals a prima facie case of injurious falsehood in respect of any of the respondents or a serious question to be tried. In relation to the conduct on the part of Dr Harvey in agitating the question of whether the applicants may have endorsed numbers fraudulently upon print advertisements, the evidence seems to me to reveal a prima facie basis for concluding that such suggestions were made recklessly and not merely in a careless way. The current authorities suggest that although malice must be shown in establishing a cause of action based on injurious falsehood, an intent to injure 'without just cause or excuse' may be sufficient. I am satisfied that there is at least a serious question to be tried as to the factual matrix surrounding the question of the circumstances in which Dr Harvey elected to agitate the possibility with a number of parties that the sponsor applicant may have engaged in the suggested conduct. See the discussion in Fleming, The Law of Torts, 9th Ed, 1998 and the discussion in Orion Pet Products v RSPCA (supra) at [195] to [225]. 79 The respondents further contend that there is no material which would suggest that any undertaking offered by the applicants is of substance. It seems to me that the affidavits of Lauren Rignall of 29 May 2006 and 13 June 2006 demonstrate substance on the part of the applicants in relation to the undertaking as to damages. 80 Accordingly, I propose to make an order in these terms. 1. Upon the applicants by their counsel giving the usual undertaking as to damages, the respondents (and each of them by themselves, their servants or agents or otherwise howsoever) are restrained until the trial of the action or until further earlier order from publishing on a website described as www.consumerhealthwatch.net.au or otherwise a report described as 'Does Tebonin (Gingko biloba) provide relief in tinnitus?' or any document which is substantially similar to the said report in purporting to critique as part of or emanating from a process of review of the product Tebonin applying the methodology as represented by the first respondent at a web page under the heading 'About Us' at a website described as www.consumerhealthwatch.net.au under the paragraphs bearing the headings 'Background' and 'The Review Process'. 2. Costs of the application are reserved.

Schwabe Pharma (Aust) Pty Ltd v AusPharm.Net.Au Pty Ltd

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Before

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Judgment (10 paragraphs)

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Legislation Cited (2)

Cases Cited (11)