Secretary, Department of Health v Oxymed Australia Pty Ltd

THE LEGISLATION 15 Before considering the contraventions and appropriate penalties, it is useful to set out the relevant parts of the TG Act, the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations) and the Therapeutic Goods Advertising Code (No.2) 2018 (Cth) (TG Advertising Code) applicable to the advertising of therapeutic goods. 16 At the outset, s 4(1) of the TG Act states that one of its objects is to: (a) provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are: (i) used in Australia, whether produced in Australia or elsewhere; or (ii) exported from Australia; … 17 The TG Advertising Code relates to the advertising of therapeutic goods, with s 6 providing that the TG Advertising Code applies to advertising of therapeutic goods that is not directed exclusively to health professionals or that is not part of a public health campaign. 18 The objects of the TG Advertising Code in s 5 include to ensure that advertising of therapeutic goods to consumers is conducted in a manner that: (a) promotes the safe and proper use of therapeutic goods by minimising their misuse, overuse or underuse; and (b) is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance; and (c) supports informed health care choices; and (d) is not inconsistent with current public health campaigns. 19 Section 10 of the TG Advertising Code provides: Advertising for therapeutic goods must: (a) support the safe and proper use of therapeutic goods by: (i) presenting the goods in accordance with directions or instructions for use; and (ii) not exaggerating product efficacy or performance; and (b) not be likely to lead to people delaying necessary medical attention or delaying the use of, or failing to use, treatment prescribed by a medical practitioner; and (c) not encourage inappropriate or excessive use of the therapeutic goods; and (d) not contain any claim, statement, implication or representation that: (i) the therapeutic goods are safe or that their use cannot cause harm, or that they have no side-effects; or (ii) the therapeutic goods are effective in all cases of a condition or that the outcome from their use is a guaranteed or sure cure; or (iii) the therapeutic goods are infallible, unfailing, magical or miraculous; or (iv) harmful consequences may result from the therapeutic goods not being used - unless the claim, statement, implication or representation is permitted under section 42DK of the Act or approved under section 42DF of the Act. 20 Against this backdrop, the Secretary alleges that Oxymed and Mr Hooper contravened s 42DLB(1) of the TG Act. Section 42DLB is the general civil penalty provision relating to advertisements of therapeutic goods. 21 Section 42DLB sits within Part 5-1 of the TG Act. Chapter 5 of the TG Act is entitled "[a]dvertising, counterfeit therapeutic goods and product tampering", and Part 5-1 applies to the advertising of therapeutic goods. The terms "advertise" and "therapeutic goods" are defined in s 3: advertise, in relation to therapeutic goods, includes the making of any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design: (a) is on the label of the goods; or (b) is on the package in which the goods are contained; or (c) is on any material included with the package in which the goods are contained. … therapeutic goods means goods: (a) that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be: (i) for therapeutic use; … and includes biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7… 22 The term "therapeutic use" is also defined in s 3 and includes use in connection with: (a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or (b) influencing, inhibiting or modifying a physiological process in persons; … 23 Section 42DLB(1) of the TG Act is the general civil penalty provision relating to advertisements and provides that: a person contravenes this subsection if: (a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods; and (b) subsection (2), (3), (4), (5), (6), (7), (8) or (9) applies to the advertisement (the "contravening provisions"). 24 The parties agree that the Respondents engaged in conduct in contravention of s 42DLB(1) by placing various advertisements to which subsections (2), (4) and/or (9) applied. These "contravening provisions" are summarised in turn below. 25 As I explain further, the parties agree that Oxymed contravened s 42DLB(1), and therefore the Court is empowered by s 42Y of the TG Act to impose a pecuniary penalty. Furthermore, the parties agree that Mr Hooper aided, abetted, counselled or procured Oxymed's contraventions of s 42DLB(1), and was therefore involved in the conduct and subject to the operation of the TG Act by reason of s 42YC. 26 The maximum penalty for each contravention of s 42DLB(1) is 5,000 penalty units for an individual and 50,000 for a body corporate. Section 4AA of the Crimes Act 1914 (Cth) relevantly provides that unless contrary intention appears, a "penalty unit" is $210, or, from 1 July 2020, $222 (the increased figure only applies to breaches that occurred after this date). 27 Therefore, the maximum penalty for each contravention is: (a) as against Oxymed, $10.5 million (or $11.1 million for contraventions after 1 July 2020); and (b) as against Mr Hooper, $1.05 million (or $1.11 million for contraventions after 1 July 2020). 28 Section 42YN of the TG Act also empowers the Court to grant an injunction to restrain a person from engaging in conduct that contravenes the TG Act or TG Regulations, where that person has engaged in or proposes to engage in such conduct.

Section 42DLB(2): "prohibited representations" 29 Section 42DLB(2) of the TG Act applies to an advertisement if it contains a "prohibited representation" about therapeutic goods where no permission has been granted by the Secretary under s 42DK; or where such a permission has been granted but the prohibited representation is not in accordance with that permission. 30 Section 42DJ(1) provides that for the purposes of Part 5-1, a "prohibited representation" is a representation about therapeutic goods of a kind specified in the TG Regulations. Regulation 6B states that "prohibited representations" include the representations described in s 30 of the TG Advertising Code. 31 Section 30 of the TG Advertising Code deals with "prohibited representations" for the purpose of regulation 6B of the TG Regulations (and in turn, s 42DLB(2) of the TG Act). "Prohibited representations" relevantly include any representations regarding the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to, the following diseases: (i) neoplastic disease; (ii) sexually transmitted diseases; (iii) human immunodeficiency virus and acquired immune deficiency syndrome (HIV AIDS); (iv) hepatitis C virus (HCV); and (v) mental illness.

Section 42DLB(4): "restricted representations" 32 Section 42DLB(4) of the TG Act applies to an advertisement if it contains a "restricted representation" about therapeutic goods where no approval under s 42DF nor permission under s 42DK is in force; or where such an approval or permission is in force but the restricted representation is not in accordance with that approval or permission. 33 A "restricted representation" is defined in s 42DD as a representation in an advertisement about therapeutic goods that refers to a form of a disease, condition or ailment identified by the TG Advertising Code as a "serious form" of that disease, condition or ailment. 34 Section 28(1) of the TG Advertising Code states that subject to subsection (2), a form of a disease, condition or ailment is a "serious form" for the purposes of s 42DD of the TG Act if: (a) it is medically accepted that the form requires diagnosis or treatment or supervision by a suitably qualified health professional, except where the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management; or (b) there is a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available for the form (including a self-administered test), which requires medical interpretation or follow-up. 35 Section 28(2) of the TG Advertising Code provides that a serious form of a disease or condition does not include pregnancy, or any of the diseases mentioned in s 30 of the TG Advertising Code (which, as set out above, relates to prohibited representations).

Section 42DLB(9): advertising unregistered therapeutic goods 36 Section 42DLB(9) of the TG Act applies to the advertising of therapeutic goods that are not entered on the ARTG and that are prescribed by the Regulations for the purpose of this subsection. 37 Regulation 7 of the TG Regulations prescribes certain therapeutic goods for the purpose of s 42DLB(9). Relevantly, regulation 7(i) prescribes therapeutic goods that are not the subject of an exemption, approval or authority under the TG Act or the TG Regulations. In other words, s 42DLB(9) and regulation 7(i) prohibit the advertising of therapeutic goods which are not entered on the ARTG, or otherwise subject of an exemption, approval or authority.

THE EVIDENCE 38 The Secretary relied on the following evidence: (a) Two affidavits of Mr Ian Wooldridge, currently a lead investigator with Consumer Affairs, dated 19 August 2020 and 24 May 2021. At the time he made his affidavits, Mr Wooldridge was an Advertising Investigator in the Advertising, Compliance and Investigations Section (ACIS) of the Regulatory Compliance Branch of the Therapeutic Goods Administration (TGA). Mr Wooldridge annexed screen captures he had taken of the Website and the Facebook Page between 20 February 2020 and 24 May 2021. In his first affidavit, Mr Wooldridge explained the methods he used to take the screen captures, and annexed a number of letters from the TGA to Mr Hooper and Oxymed taken from the TGA's electronic files and an e-mail inbox used by ACIS officers. (b) One affidavit of Ms Gluer, a lawyer with the Australian Government Solicitor (AGS), dated 20 August 2020. Ms Gluer had carriage of this matter for the Secretary. Ms Gluer's affidavit annexed an expert report from Dr Brownscombe, two VCAT decisions relating to Mr Hooper and his previous company, HyperMED Neurorecovery Australia Pty Ltd, and copies of the five infringement notices served by the TGA on the Respondents. (c) One affidavit of Mr Matthew Garey, a Senior Executive lawyer with the AGS, dated 28 May 2021. Mr Garey's affidavit annexed correspondence from the AGS to the Respondents' lawyers relating to the Website being back online as at 18 January 2021. (d) Expert evidence of Dr Jeffrey Brownscombe, a registered medical practitioner and the Assistant Director and Senior Medical Adviser at the Devices Clinical Section in the Medical Devices Authorisation Branch of the TGA. Dr Brownscombe prepared a first report dated 20 July 2020 and two supplementary reports which were annexed to his affidavit dated 4 February 2021. (e) Expert evidence of Professor Michael Bennett, the Conjoint Professor of Anaesthesia and Hyperbaric Medicine at the Prince of Wales Clinical School UNSW Faculty of Medicine in Sydney. Professor Bennett is also the Academic Head of Anaesthesia at the Prince of Wales Hospital and a clinician at the Prince of Wales Hospital in both Anaesthesia and Diving and Hyperbaric Medicine. Professor Bennett made one report which was annexed to his affidavit of 28 May 2021. 39 Oxymed and Mr Hooper relied on the affidavit of Mr Avi Furstenberg made 13 July 2021. Mr Furstenberg is a principal at Furstenberg Law, and had carriage of this matter for the Respondents. Mr Furstenberg also has the carriage of a separate Worksafe prosecution proceeding against Oxymed and Mr Hooper in the County Court of Victoria. 40 Mr Furstenberg gave evidence as to the state of Mr Hooper's finances. Mr Hooper's representation in the County Court proceeding was funded by Victoria Legal Aid, with the condition that Mr Hooper repay the sum of $171,054 in monthly instalments of $200. Mr Furstenberg's evidence is that Mr Hooper also has a number of outstanding costs orders against him in relation to "other matters". A letter from Holding & Redlich annexed to Mr Furstenberg's affidavit refers to five costs orders related to the VCAT Proceedings (discussed below), and seeks payment of $590,685 (plus GST) in satisfaction of the costs orders. 41 As noted above, due to the COVID-19 pandemic the witnesses other than Ms Gluer and Mr Furstenberg appeared via Microsoft Teams and adopted the contents of their affidavits at the hearing. Professor Bennett was the only witness required for cross-examination. 42 The following background is based on the SAFA and SSAFA, the documents annexed to the affidavits of Mr Wooldridge and Ms Gluer and the expert evidence.

Background 43 In May 2010, the Chiropractic Board of Australia brought disciplinary proceedings against Mr Hooper. The proceedings occupied 66 sitting days before a three-member VCAT Tribunal between January and May 2013. The allegations concerned, amongst other things, advertising on Mr Hooper's website alleged to be misleading or deceptive. The decision of the Tribunal is reported at Chiropractic Board of Australia v Hooper (Review and Regulation) [2013] VCAT 878 (the VCAT Proceedings). 44 At the time of the VCAT Proceedings Mr Hooper was the sole director of the HyperMED Neurorecovery Australia Clinic (HyperMED) and provided HBOT through that clinic. 45 The VCAT Proceedings concerned a client of HyperMED, QS, who had cerebral palsy. At [11] the Tribunal noted that QS searched the internet and found the site "HyperMED Neurorecovery Australia". The Tribunal noted at [11] that Mr Hooper informed them that the HyperMED website contained in excess of 900 professional articles as well as commentary and testimonials. At [31] the Tribunal referred to a section of the HyperMED website headed "Conditions Treated", which gave a long list of conditions under the words "Disorders treatable with Hyperbaric Oxygen Therapy (HBOT)". The conditions listed included Alzheimer's disease, autism, diabetes, cerebral palsy and infertility. 46 QS had his first HBOT treatment on 27 August 2007. At [27] the Tribunal noted that by 13 May 2008, QS had completed 269 hours in the HBOT chamber. 47 The Tribunal made findings against Mr Hooper, and a further hearing was held in July 2013 to make a determination pursuant to s 77(4) of the Health Professions Registration Act 2005 (Vic) in relation to the appropriate penalty. The Tribunal's reasons dated 2 August 2013 are found at Chiropractic Board of Australia v Hooper (Review and Regulation) [2013] VCAT 1346 (the VCAT Penalty Proceedings). 48 In the VCAT Penalty Proceedings, the Tribunal reprimanded Mr Hooper and cancelled his registration as a chiropractor, disqualifying him from applying for re-registration for two years. The Tribunal also ordered that Mr Hooper pay the costs of the Chiropractic Board of Australia. 49 The Tribunal accepted an undertaking proffered by Mr Hooper that he would not provide HBOT treatment in respect of ten conditions, including adult cerebral palsy, infertility and reducing the risk of cancer cell mutation. 50 Mr Hooper also undertook that he would provide the following information to prospective patients and/or their parents or guardians in respect of a list of other conditions, including cerebrovascular stroke, autism, coronary heart disease, hepatitis and multiple sclerosis: (a) the provision of HBOT for the condition is novel; (b) the consensus of expert medical opinion in Australia and in the scientific literature is that such treatment for the condition is of little or no benefit; (c) the provision of such treatment is relatively safe but is not free from risk, including the risk of short term myopia, barotrauma, claustrophobia, fitting in epileptics, pneumothorax (and any other material risk pertaining to the particular patient); and (d) the likely treatment cost. 51 At some stage after the VCAT Proceedings, Mr Hooper ceased providing services under the HyperMED Clinic name. Oxymed was registered as a company on 24 June 2015. Mr Hooper was and is its sole director, and continued to provide HBOT services through the Oxymed clinic. 52 Almost two years prior to the Relevant Period, on 30 May 2018, the TGA's Advertising Compliance Unit (TGA ACU) sent Oxymed an email attaching a letter dated 29 May 2018 notifying Oxymed that the TGA ACU had received a complaint about Oxymed's advertising of HBOT devices. The complaint concerned the advertising of HBOT devices despite the HBOT devices no longer being entered on the ARTG. The letter referred to a range of criminal and civil penalty provisions the TG Act relating to advertising, attaching relevant extracts including s 42DLB and parts of the TG Advertising code, as well as a copy of a document entitled "therapeutic goods advertising - compliance and enforcement tools". 53 On 31 May 2018, Mr Hooper responded to the TGA ACU denying any contravention of the TG Act on the basis that Oxymed did not provide "soft" HBOT and that the "solid steel" HBOT devices featured at Oxymed were registered by Hyperbaric Technologies Australia in 1995. The email also referred to the VCAT Proceedings: I gave an undertaking not to treat 10-conditions, which was accepted in the VCAT Final Orders… The VCAT Final Orders, ruled that Dr Hooper was of "good character", "unyielding in his belief"… The VCAT Final Orders ruled that there were to be "no imposed restrictions" to the "treatable conditions" I have been treating for the past 20+ years using Hyperbaric Oxygen Therapy… 54 On 4 June 2018, the TGA ACU sent an email to Oxymed noting that it had decided to resolve the complaint by sending an educational obligations notice. This was said to "provide you with an opportunity to review your advertising material and to ensure that your advertising is compliant, rather than simply exercising our new regulatory tools noted in the attachment to the notice". The email included a screenshot from the Website containing an impermissible representation. 55 The 4 June 2018 email concluded by strongly suggesting that Oxymed review its advertising material in detail to ensure compliance with the regulatory framework, noting in particular "the numerous references to restricted and prohibited references and the high-level scientific claims made on the website"; and warning that where matters resurface after the TGA has "taken the time to remind advertisers of their responsibilities it is likely to be considered to represent deliberate non-compliance with the regulatory framework and the TGA will need to consider escalating its response". 56 There does not appear to have been any further contact between the parties between the 4 June 2018 email and March 2020. 57 On 26 March 2020, the TGA sent Oxymed an "Immediate Notice to Cease and Desist" (the Notice). The Notice, addressed to Mr Hooper, referred to unlawful advertising of the HBOT device on the Website, noting that HBOT devices are not entered on the ARTG or otherwise exempt, approved or authorised under the TG Act. The Notice stated: The Therapeutic Goods Administration (TGA) considers that this case is particularly serious due to the representations on the Website concerning a number of diseases that cause considerable fear and anxiety, including HIV AIDS, cancer and COVID-19. Representations concerning such conditions prey on vulnerable people, and can impair the efforts of governments across Australia to address significant public health issues. The representations made concerning COVID-19 are of significant concern to the TGA and the Australian Government more broadly, given the current pandemic. 58 The Notice warned of potential civil penalties of up to $1.05 million for an individual or $10.5 million for a body corporate. Reference was made to Secretary, Department of Health v Peptide Clinics Australia Pty Ltd [2019] FCA 1107 (Peptides), in which this Court awarded civil penalties totalling $10 million in relation to contraventions of the advertising provisions of the TG Act. I consider the Peptides case in greater detail below. 59 The Notice stated that Oxymed should (emphasis in original): [I]mmediately cease advertising the Device on the Website, and cease making representations that HBOT is capable of treating COVID-19, HIV AIDS, cancer and other serious diseases, conditions or disorders. [I]mmediately cease advertising the Device, and cease making representations that HBOT is capable of treating COVID-19, HIV AIDS, cancer and other serious diseases, conditions or disorders on any other online platforms connected or associated with Oxymed Australia Pty Ltd, including social media. This should include reviewing [the Facebook Page] and removing any posts or other content that contravenes the Act. 60 The Notice warned that if the Website or other online platforms within Oxymed's control (including the Facebook Page) continued to advertise the HBOT devices and make the relevant representations after 5pm on 30 March 2020, the TGA would take further steps to prevent, and impose sanctions in relation to, the unlawful advertising. The further steps were said to include commencing legal proceedings. 61 The Notice enclosed five infringement notices addressed to Oxymed and Mr Hooper, in respect of alleged contraventions of subsections 42DLB(2), (4), and (9) of the TG Act on 14 November 2019, 11 March 2020, 20 March 2020 (two contraventions) and 23 March 2020 (together, the Infringement Notices). Each infringement notice imposed a penalty of $12,600. Each infringement notice identified the relevant section of the TG Act that the delegate reasonably believed to have been contravened and provided the details of the alleged contravention. To summarise, the details of the five alleged contraventions were: (a) Infringement notice 1: on 20 March 2020, Oxymed contravened s 42DLB(1) (due to the application of subsection (9)) by advertising HBOT devices on the Website in circumstances when the HBOT devices were not entered on the ARTG; (b) Infringement notice 2: on 20 March 2020, Oxymed contravened s 42DLB(1) (due to the application of subsection (2)) by making prohibited representations in advertisements on the Website regarding the treatment of cancer; (c) Infringement notice 3: on 11 March 2020, Oxymed contravened s 42DLB(1) (due to the application of subsection (4)) by making restricted representations in advertisements on the Website regarding the treatment of COVID-19; (d) Infringement notice 4: on 14 November 2019, Oxymed contravened s 42DLB(1) (due to the application of subsection (2)) by making prohibited representations in advertisements on the Website regarding the treatment of PTSD; and (e) Infringement notice 5: on 23 March 2020, Oxymed contravened s 42DLB(1) (due to the application of subsection (2)) by making prohibited representations in advertisements on the Website regarding the treatment of HIV AIDS. 62 On 27 March 2020, Mr Wooldridge rang Mr Hooper and confirmed that he had received the Notice and the Infringement Notices. 63 In the afternoon of 27 March 2020, Mr Hooper sent an email to Mr Wooldridge in which he confirmed that he had instructed Oxymed's web manager to remove content from the Website, including references to the HBOT Device and sections on COVID-19, HIV AIDS, cancer support and PTSD. Mr Hooper also stated that he had "instructed other 'serious medical conditions' to be removed, in accordance with your correspondence". 64 On 3 April 2020, Mr Wooldridge sent an email to Mr Hooper and Oxymed attaching a "Final Notice to Cease and Desist" (Final Notice). The Final Notice appears to have been issued because the contravening representations had not been removed from the Website or Facebook Page. The Final Notice stated (emphasis in original): We are providing you with one final opportunity to: (a) immediately cease advertising the Device on the Website, and cease making representations that HBOT is capable of treating COVID-19, HIV AIDS, cancer and other serious diseases, conditions or disorders; and (b) immediately cease advertising the Device, and cease making representations that HBOT is capable of treating COVID-19, HIV AIDS, cancer and other serious diseases, conditions or disorders on any other online platforms connected or associated with Oxymed Australia Pty Ltd, including social media. This should include reviewing the following Facebook page, https://www.facebook.com/oxymedaustralia/ and removing posts or other content that contravenes the Therapeutic Goods Act 1989 (the Act). 65 The Final Notice referred to Mr Hooper's email dated 27 March 2020, and set out the content that Mr Hooper had said would be removed. The Final Notice went on to say: Despite your assurances that you have removed the above content from the Website, our review of the Website shows that you have not, in fact, taken down the unlawful content in question from the Website. Unlawful advertisements also continue to be displayed on the Oxymed Facebook page, despite our letter of 26 March 2020 having clearly stated that the relevant material needed to be removed from that page as well. We consider that this failure to take the necessary steps to put an end to your unlawful advertising demonstrates a poor attitude toward compliance with the Act, and needs to be immediately addressed. 66 The Final Notice reiterated that if the Website or other online platforms including the Facebook Page continued to unlawfully advertise after 5pm on 6 April 2020, the TGA would take further steps to prevent, and impose sanctions in relation to, that unlawful advertising. 67 The Final Notice also set out a longer list of the serious diseases, conditions or disorders that were still being advertised on the Website on 31 March 2020 and on the Facebook Page on 1 April 2020 when the TGA conducted a review of both platforms. The Final Notice said that the advertisements "must immediately cease". 68 On 6 April 2020, Mr Hooper wrote to Mr Woolridge stating that Oxymed had "(hopefully) removed all links and URL's [sic] from [the Website]", as well as "all photographs and blogs from the [Facebook Page]". 69 By 22 April 2020, the Respondents had engaged solicitors, who wrote to the TGA requesting that the Infringement Notices be withdrawn as the material had been taken down. The letter also sought clarification as to the registration status of the HBOT devices, as the Respondents had been assured by the manufacturer, Mr Zeigler of Hyperbaric Technologies Australia, that the HBOT devices were "grandfathered" onto the ARTG. 70 On 23 April 2020, the TGA advised that the request to withdraw the Infringement Notices had been refused, noting "the seriousness of the breaches and the potential harm to public health and safety". 71 On 24 April 2020, the Respondents' solicitors wrote to the TGA requesting an extension of time (two months) for the consideration and payment of the Infringement Notices. The solicitors indicated that the Respondents had engaged new legal representatives, so the extension was needed to provide detailed instructions. 72 On 29 April 2020, Mr Hooper himself emailed the TGA requesting leniency in the matter. Mr Hooper also stated that Oxymed had never treated COVID-19 patients, and that the information on the Website "was based on the fact that the site is an educational platform to both medical and allied health care professions on the topic of HBOT" (emphasis in original). He also repeated the claim that the manufacturer of the chambers Mr Zeigler had assured him that the chambers "are conforming and 'grandfathered' onto the ARTG list" (emphasis in original). 73 On 1 May 2020 the TGA granted an extension of time for payment of the Infringement Notices to 30 June 2020, noting that Oxymed "must immediately remove all references to restricted and prohibited representations from the website and bring the site into compliance". Examples of such representations still on the Website included "Post Concussion Symptom - Athletes & Suspected Head Injury" and PTSD. 74 On 6 and 7 May 2020, Mr Hooper sent two further emails to the TGA. The 6 May 2020 email referred to a media release dated 3 May 2020 from the Tasmanian Minister for Health, Sarah Courtney, advising that a new Department of Diving and Hyperbaric Medicine had opened at the Royal Hobart Hospital. He also stated that "the new Tasmanian chamber is manufactured by Eric Fink, who I have known personally for over 20 years" and provided a link to Fink Engineering's ARTG registration. 75 The 7 May 2020 email referred to and attached documentation from an upcoming clinical trial on Hyperbaric Oxygen and COVID-19 in the US. After highlighting an extract from the documentation, Mr Hooper stated "this extract from Page 6 of the Clinical Trial submission is exactly what I stated on our website at the time of TGA intervention". 76 On 21 May 2021 the TGA sent a letter to the Respondents' solicitor, responding to Mr Hooper's emails dated 6 and 7 May 2020 and to the extension of time request made on 24 April 2020. The letter stated the following (emphasis in original): On 1 May 2020, the delegate considered your request, on behalf of your client, for an extension of 2 months to pay the infringement notices given to Oxymed on 26 March 2020 and decided under subsection 42YKB(2) of the Therapeutic Goods Act 1989 (the Act), to extend the timeframe for payment to 30 June 2020. This extension was granted on the basis that Oxymed immediately remove all references to restricted and prohibited representations from the website, and bring the site into compliance. Examples of restricted and prohibited representations on the Oxymed website were provided, including, but not limited to, representations which referred to: a. Post Concussion Symptom - Athletes & Suspected Head Injury, being a restricted representation within the meaning of the Act and s 28 of the paragraph 28(1)(a) of the Therapeutic Goods Advertising Code (No.2) 2018 (the Code); and b. Post Traumatic Stress Disorder, a prohibited representation within the meaning of the Act and section 30 of the Code. Those advertisements continue to be displayed on the Oxymed website, in what the TGA considers a flagrant and deliberate contravention of the Act. In addition to the advertising present on the website on 1 May 2020, your client now appears to have added further web content that contains restricted and prohibited representations concerning the use of Hyperbaric Oxygen Therapy Chambers (HBOT). These further representations include, but are not limited to content relating to spinal cord and brain injuries, stroke recovery, cerebral lupus and other serious medical conditions (see, for example, https://www.oxymed.com.au/fundingsubmissions). If your client's unlawful advertising continues, in the face of repeated and clear warnings from the TGA and after Oxymed has been given a number of infringement notices in relation to such unlawful advertising, the TGA will be forced to escalate its enforcement response. This will include, but is not necessarily limited to, withdrawing the infringement notices and immediately commencing proceedings against Oxymed (and Mr Hooper, as a senior officer of that company) in the Federal Court of Australia seeking pecuniary penalty orders and an urgent interlocutory injunction to bring about the cessation of the unlawful advertising. Please confirm by 5pm on 25th May 2020, that your client has removed all references to restricted and prohibited representations from the website and has brought the Website into compliance. If we do not receive that confirmation, or if prohibited and restricted representations continue to be made on your client's website after that date, the TGA may take further enforcement action without any prior notice to your firm or your client. Mr Hooper's emails of 6 and 7 May 2020 Mr Hooper has sent the enclosed emails dated 6 and 7 May 2020 to the TGA. Those emails appear to be seeking to argue that Oxymed's conduct was either lawful, or was not serious in nature, because: a) HBOT chambers have been included in the Australian Register of Therapeutic Goods (ARTG) by other persons without providing specific indications (we note that this has no bearing on whether the HBOT chambers used by Oxymed are, in fact, included in the ARTG); and b) a clinical trial submission indicated that a person has theorised that HBOT may be beneficial in treating 'cytokine storms', which may arise in the course of the progression of COVID-19. Neither of those emails appears to have any substantive relevance to the issues at hand. The content of ARTG entries for other HBOT devices has no bearing on the fact that the HBOT devices advertised by Oxymed were not included in the ARTG, with the result that the relevant advertising contravened the Act. Further, the fact that a person has theorised about a potential treatment (presumably to be tested through the clinical trial) for COVID-19 using HBOT is, again, immaterial to the delegate's decision to give an infringement notice to Oxymed concerning advertising HBOT for COVID-19 related indications. Representations concerning the treatment of COVID-19 are restricted representations. Such representations may not be made in advertisements for therapeutic goods unless a relevant approval or permission is in place, which was not the case here. Whether there is a factual basis for the claims made in Oxymed's advertising (to the extent that a hypothesis advanced in a clinical trial submission could be characterised as reliable clinical evidence, which is questionable) is immaterial to the contravention alleged - regardless of whether the representation is true, making it is unlawful. This prohibition is in place because, as a matter of policy, consumers should receive information about the treatment of serious medical conditions from qualified health practitioners, rather than commercial advertising on the internet or in other locations. If your client wishes to request that the notices be withdrawn, it should make a written submission to the delegate for that purpose. That being said, nothing in the correspondence to date would appear to provide any substantive basis for seeking the withdrawal of the notices, and indeed your client's ongoing non-compliance with the Act would weigh heavily against such a decision. If your client does not immediately remove the unlawful advertising from its website, the TGA will take all necessary steps to ensure your client's non-compliance ceases. As noted above, if your client will not come into compliance based on the action taken to date, the TGA will be forced to take further enforcement action, including obtaining urgent interlocutory relief from the courts. 77 On 25 May 2020 Mr Hooper emailed the TGA, attaching a letter stating that the infringement notices should be withdrawn on the basis that: (a) neither he nor Oxymed were the sponsor of HBOT devices used to administer HBOT at the Oxymed clinic; (b) the HBOT devices were "grandfathered" onto the ARTG and therefore were entered on the ARTG; (c) various content on the Website was of an "educational" nature and therefore did not constitute advertising; and (d) the Oxymed clinic had suffered a significant financial downturn since COVID-19. 78 On 23 June 2020 the TGA sent an email and attached letter refusing to withdraw the infringement notices and setting out the reasons for the refusal, noting: (a) the TGA accepted that Mr Hooper and Oxymed were not the sponsor of the HBOT devices, nor did they manufacture or import the HBOT devices; (b) the HBOT devices were not entered in the ARTG, and the company named by Mr Hooper as having a registration did not have devices of any kind entered on the ARTG. This was clear from searches of the public version of the ARTG on the TGA website; (c) the submission that the content on the Website was "educational" was rejected. The Website was said to include a range of content relating to the HBOT services provided at the Oxymed clinic, including pricing information and a "Patient Handbook". The Website, when viewed as a whole, was clearly intended to promote the use or supply of the devices (by way of administration of HBOT to a patient) and therefore constituted advertising within the meaning of the TG Act; (d) the TGA noted that Oxymed could not make any prohibited or restricted representations on the Website unless that representation was subject to a relevant approval or authority. A list of examples of restricted and prohibited representations that had been or continued to be on the Website was included as Annexure A to the letter; (e) Annexure A listed 53 diseases or conditions in respect of which restricted representations had been made, including Alzheimer's disease and COVID-19, and six diseases or conditions the subject of prohibited representations; and (f) as to Oxymed's financial position, the TGA finished by noting that it did not have sufficient financial information to be able to decide whether to withdraw the infringement notices on the basis that the payment of the infringement penalties would cause financial hardship. Oxymed was invited to provide further information in relation to its financial hardship.

The proceedings 79 The Secretary commenced the proceedings on 20 August 2020. 80 The Website was taken down with no admission as to liability on 21 August 2020. This fact was noted in the orders of Beach J made on 24 August 2020. The orders provided that pending further or other order, the Respondents would not put the Website back online without the prior written consent of the Secretary. 81 The Respondents removed posts from the Facebook Page on 28 September 2020. This was noted in the orders of Beach J made on 28 September 2020. 82 On 18 January 2021, the AGS wrote to Oxymed and Mr Hooper's lawyers referring to the 24 August 2020 orders and noting that the website was back online without the Secretary's consent. The website was taken down on 20 January 2021. 83 The SAFA was signed by all parties on 14 April 2021. 84 Schedule A to the SAFA sets out each condition the subject of a restricted representation in the advertisements, and the number of days which the various advertisements remained posted on the Website and Facebook Page. Schedule B does the same for the conditions the subject of prohibited representations. I note that for many of the conditions listed in the Schedules there are two periods given, the first being immediately after the date for cessation given in the Notice (31 March 2020) to early April, and a later period of mid-May or mid-June to mid-August 2020. 85 On 20 April 2021, the AGS wrote to Oxymed and Mr Hooper's lawyers in relation to content on Mr Hooper's LinkedIn page. The LinkedIn page was said to contain content similar to that which the Respondents admitted had constituted prohibited and restricted representations in the SAFA. The letter attached screenshots of the LinkedIn page, including links relating to the role of HBOT in treating COVID-19 and aggressive brain tumours. The LinkedIn page described Mr Hooper as "an 'influencer', founder and director of OXYMED (formerly HyperMED) where … he gained international renown for providing the wider 'off-label' applications of Hyperbaric Oxygenation"; and Mr Hooper's posts contained links to similar material that had appeared on the Facebook Page and Website. 86 The AGS letter noted the Secretary's concern that Mr Hooper's conduct by posting the content on his LinkedIn page "reflects a failure to appreciate his and, by association Oxymed's, obligations with respect to advertising therapeutic goods". 87 On 27 April 2021, the Respondents' lawyers advised that the LinkedIn page had been taken down.

Oxymed and Mr Hooper 88 Oxymed is an Australian company incorporated in June 2015, with its registered office in Victoria. It has one issued $1 share held by Ms Kate Hooper. 89 Mr Hooper is the sole director and secretary of Oxymed. Mr Hooper was responsible for managing the day-to-day operations of Oxymed during the Relevant Period, including management and oversight of the administration of HBOT to clients, and management and approval of material posted on the Website and Facebook Page. 90 Throughout the Relevant Period, Oxymed carried on a business of administering HBOT via HBOT devices to customers. The cost of HBOT treatment during the Relevant Period was $129.59 per hour. 91 Eighty clients were treated by Oxymed during the Relevant Period. Of those 80 clients, 25 suffered from the conditions set out in Schedules A and B to the SAFA. Oxymed's turnover during the Relevant Period divided by 80 clients suggests that approximately 2500 hours of HBOT treatments was carried out during that time. However, there was no evidence as to the number of hours each client spent undertaking HBOT treatments during the Relevant Period.

The Website and the Facebook Page 92 Oxymed promoted the HBOT services through posts on its Website and its Facebook Page. Oxymed operated both the Website and the Facebook Page. Mr Hooper was responsible for all content that was published, and had oversight and authority over what was included or excluded on the Website and Facebook Page. 93 The posts on the Website and Facebook Page include links to many pseudo-scientific articles, testimonials from clients and Mr Hooper's speaking engagements. The overall impression intended to be imparted to the vulnerable non-scientific reader from the deluge of apparently scientific articles is that HBOT is a credible form of treatment for many diseases and chronic conditions. 94 The hourly cost displayed on the Website screenshots taken during the Relevant Period ranged between $140 to $250, which is described as "reasonable" in comparison to non-hospital HBOT provider costs in the US which are quoted at US$300 to US$450 per session. The Website screenshots also note that "most patients are required to commence HBOT daily" and "[t]ypically most patients with a complex disorder require a 'saturative baseline' of between 40-60 and often up to 80-100 hours to 'commence' functional changes and stabilisation". 95 Examples of the material posted on the Website and Facebook Page during the Relevant Period include: Coronavirus: Hyperbaric Oxygen Therapy is effective in treating both the primary infection but also the cascading challenges associated with the coronavirus immune response. Concussions: Hyperbaric Oxygen Therapy: The battle to help cure concussions "it reduces inflammation in the body and also helps promote the formation of stem cells that can..." Cerebral Palsy: Cerebral Palsy & Development delay, near drowning speech delay… Malcolm R Hooper Hyperbaric Oxygen Therapy combined with Robotic Exoskeleton assisted walking for cerebral palsy… Multiple sclerosis: OXYMED provides saturative locks of HBOT combined with Australian first LOKOMAT (Robotic Gait Training - Adult and Paediatric) to promote neuroplasticity… OXYMED combination protocols "awakens" dormant neural pathways and provides accurate neurological repetition enhancing and re-training connections and pathways in the brain and spinal cord. Patients have the ability to "salvage back" what has been damaged - the capacity to wake-up dormant pathways, rewire, retrain and reconnect function improving brain and spinal cord function.

Expert Evidence 96 Professor Bennett and Dr Brownscombe were asked to give their opinion, based on their training, knowledge and experience, as to whether HBOT is a scientifically or clinically accepted treatment for any of the conditions listed in Schedule A to the SAFA. Professor Bennett was also asked to consider the diseases in Schedule B. Professor Bennett and Dr Brownscombe were also instructed to consider whether there were any adverse consequences or risks for patients with any of the Schedule A conditions who pursue HBOT where HBOT is not a scientifically or clinically accepted treatment for that condition. 97 Dr Brownscombe was also asked to prepare a supplementary expert report and provide his opinion as to whether each of the conditions listed in Schedule A was a disease, condition, ailment or defect: (a) that is medically accepted to require diagnosis or treatment or supervision by a suitably qualified health professional, except where that form has been medically diagnosed and medically accepted as being suitable for self-treatment and management; or (b) for which there is a diagnostic (including screening) preventative, monitoring, susceptibility or pre-disposition test available (including a self-administered test), which requires medical interpretation or follow-up. 98 Dr Brownscombe was also asked to indicate whether, in his opinion, HIV/AIDS, cancer, depression, glioblastoma, mental health and post-traumatic stress disorder, were a form of any of the following: (a) neoplastic disease; (b) sexually transmitted diseases; (c) HIV/AIDS; (d) hepatitis C virus; or (e) mental illness.

The SAFA conditions 99 In the expert opinion of Dr Brownscombe, each of the 49 conditions listed in Schedule A were conditions which are medically accepted to require diagnosis, treatment, or supervision by a suitably qualified health professional. In respect of three of the listed conditions (back pain, burns and irritable bowel syndrome) Dr Brownscombe qualified his response by noting that mild variants may not require medical diagnosis or treatment. 100 Dr Brownscombe's evidence was that HBOT was a first line treatment for decompression sickness. Additionally, Dr Brownscombe gave evidence that HBOT is an "adjunctive" treatment (that is, it supports the main treatment) for a number of further conditions including carbon monoxide poisoning, necrotising soft tissue infections, and idiopathic sudden sensorineural hearing loss. 101 Professor Bennett's evidence was that four of the conditions in the list shown to him (carbon monoxide poisoning, hearing loss, sensorineural hearing loss and radiation necrosis) were "widely accepted as appropriate for the routine application of HBOT". 102 In Professor Bennett's opinion, the clinical evidence strongly supported the assertion that HBOT is not warranted in the treatment of multiple sclerosis, cerebral palsy and autism spectrum disorders. For the remaining conditions, including those in Schedule B, his opinion was that HBOT was not a scientifically and clinically accepted treatment. Professor Bennett noted that high quality evidence in support of the routine use of HBOT required randomised controlled trials or systematic reviews of such trials, and such randomised controlled trials of HBOT are difficult as there is a substantial placebo effect. 103 Professor Bennett's report referred to an article he had co-authored entitled "Unestablished indications for hyperbaric oxygen therapy" in which he wrote: Hyperbaric oxygen treatment (HBOT) is a therapeutic modality that has long struggled for credibility within "mainstream" medicine. In large part this has been due to a lack of high-quality evidence to support HBOT in its various indications. 104 For conditions where there is a known benefit to providing HBOT, HBOT is provided in a hospital based facility. There is at least one hospital HBOT facility in each state in Australia, and two in some states.

Effects of HBOT 105 Dr Brownscombe gave evidence as to the effects on the human body of breathing 100% oxygen at increased atmospheric pressure (HBOT is intended to deliver oxygen at 100% concentration and at a pressure above atmospheric pressure and is administered using HBOT devices). Dr Brownscombe identified two main effects. First, the increased pressure reduces the volume of gas-filled spaces, forming the basis for treatment of decompression sickness and air embolism. Second, an increased amount of oxygen dissolves in the bloodstream, meaning more oxygen is delivered to the body's organs and tissues, forming the basis for treatment of conditions where impaired oxygen-carrying capacity is evident, such as carbon monoxide poisoning and severe anaemia, and where improved blood supply can improve tissue healing, such as ulcers. 106 While Professor Bennett agreed that HBOT is relatively benign when compared to many medical interventions, he noted that there was the potential for financial and physical harm to patients. An inflated belief of expected benefit from HBOT may have consequences for patients and their families. As Professor Bennett noted in his article "desperate patients with chronic or progressive problems are frequently willing to 'try anything', and it is not difficult to convince such patients to try HBOT". In choosing the "unproven" HBOT a patient may be prevented from using alternative, more effective therapies or treatments. Not only is there the loss of opportunity for the best possible treatment, there is also a financial burden to the patient in paying for the HBOT. 107 Dr Brownscombe also gave evidence as to the potential risk to patients from pursuing HBOT at the expense of pursuing established treatment for their conditions, which could lead to their conditions worsening, or in some conditions even death. Dr Brownscombe agreed that another form of potential harm to HBOT patients was financial harm from the cost of HBOT treatment.

THE CONTRAVENING CONDUCT 108 Oxymed and Mr Hooper admitted (and the expert evidence establishes) the contraventions of s 42DLB(1) of the TG Act during the Relevant Period alleged by the Secretary. 109 Oxymed and Mr Hooper admitted that Mr Hooper aided, abetted, counselled or procured Oxymed's contraventions of s 42DLB(1) and was therefore involved in those contraventions for the purposes of s 42YC of the TG Act.

Advertising goods not listed in the ARTG 110 Oxymed and Mr Hooper admit (consistently with Dr Brownscombe's evidence) that: (a) the HBOT devices are therapeutic goods within the meaning of s 3 of the TG Act; (b) the HBOT devices are not, and were not during the Relevant Period, entered in the ARTG maintained by the Secretary pursuant to s 9A(1) of the TG Act; and (c) the HBOT devices are not, and were not at any relevant time, the subject of an exemption, approval or authority under the TG Act or TG Regulations. 111 Following on from the above, Mr Hooper and Oxymed admit that the HBOT devices are, and were at all relevant times throughout the Relevant Period, prescribed by regulation 7(i) of the TG Regulations for the purpose of s 42DLB(9). 112 As noted above, there was some evidence as to Mr Hooper's previously-held mistaken belief that the HBOT devices were "grandfathered" on to the ARTG. 113 The Respondents admit that throughout the Relevant Period they advertised or caused the HBOT devices to be advertised on the Website and Facebook Page, including by: (a) making statements on the Website and Facebook Page to promote the use of the HBOT devices, by participating in HBOT in the Oxymed Clinic; (b) publishing pictorial representations of the HBOT devices on the Website and Facebook Page when promoting HBOT services offered at the Oxymed clinic; (c) offering HBOT services at the Oxymed clinic and a price list for such services on the Website; and (d) promoting the health benefits of the HBOT treatment in conjunction with the treatment or cure of a variety of conditions and illnesses, including those listed at Schedules A and B of the SAFA. 114 Mr Wooldridge annexed to his affidavits screenshots of posts on the Website and Facebook Page taken during the Relevant Period. Dr Brownscombe was shown some of the screenshots and identified the devices as being hyperbaric oxygen chambers which he said were intended to deliver oxygen at 100% concentration and at increased (above atmospheric) pressure. 115 A number of the screenshots make indirect references to HBOT devices by virtue of selling HBOT services, namely the delivery of oxygen at 100% concentration and at increased pressure from HBOT devices, promoted in conjunction with the treatment or cure of certain conditions. For example one screenshot regarding COVID-19 states "Hyperbaric Oxygen Therapy is effective in treating both the primary infection but also the cascading challenges associated with the coronavirus immune response". Another screenshot describing a study regarding treatment for fatigue associated with HIV/AIDS states "Patients were treated with 100% oxygen at two atmospheres of absolute pressure three times per week for two months… It was concluded that hyperbaric oxygen therapy is an effective adjunctive treatment in the medical management of HIV/AIDS".

Restricted Representations 116 The Website and Facebook Page screenshots contain representations relating to each of the 49 conditions listed in Schedule A of the SAFA and the five conditions listed in Schedule B. 117 The Secretary's submissions set out examples of the advertisements taken from the screenshots of the Website and Facebook Page captured by Mr Wooldridge and alleged to contain restricted representations: Coronavirus: "Hyperbaric Oxygen Therapy is effective in treating both the primary infection but also the cascading challenges associated with the coronavirus immune response." Concussions: "Hyperbaric Oxygen Therapy: The battle to help cure concussions "it reduces inflammation in the body and also helps promote the formation of stem cells that can..." Cerebral Palsy: "Cerebral Palsy & Development delay, near drowning, speech delay... Malcolm R Hooper Hyperbaric Oxygen Therapy combined with Robotic Exoskeleton assisted walking for cerebral palsy..." and under the heading "WORLD leading experts" "Dr Arun Mukherjee...HBOT has shown to have positive therapeutic effects on children with cerebral palsy in many clinical trials. However, there is still controversy and resistance to the recognition of cerebral palsy as an indication for HBOT... the eight month long benefits we have observed with combined treatments versus rehabilitation can only have been due to a beneficial effect of hyperbaric treatment." Multiple sclerosis: "OXYMED provides saturative locks of HBOT combined with Australian first LOKOMAT (Robotic Gait Training- Adult and Paediatric) to promote neuroplasticity...OXYMED combination protocols 'awakens' dormant neural pathways and provides accurate neurological repetition enhancing and re-training connections and pathways in the brain and spinal cord. Patients have the ability to 'salvage back' what has been damaged - the capacity to wake-up dormant pathways, rewire, retrain and reconnect function improving brain and spinal cord function." 118 The Respondents admit (consistently with Dr Brownscombe's unchallenged expert evidence) that each of the conditions listed in Schedule A is a "serious form" of a disease, condition, ailment or defect within the meaning of ss 42DD and 42DLB(4) of the TG Act. Therefore, each of the representations that contained reference to any of the 49 conditions listed in Schedule A are "restricted representations" within the meaning of s 28 of the TG Advertising Code. 119 The Respondents admit that, during the Relevant Period from at least 11 March 2020, they advertised or caused to be advertised the HBOT devices in circumstances where those advertisements contained restricted representations. The Respondents further admit that they did not have approval from the Secretary under s 42DF(1) of the TG Act, or permission under s 42DK(1) to make the restricted representations on the Website or Facebook Page.

Prohibited representations 120 Mr Wooldridge's evidence included screenshots from the Website and Facebook Page containing references to the use of HBOT devices in conjunction with HBOT, to assist in the treatment of cancer, AIDS/HIV and mental illness. 121 Examples of the advertisements taken from the screenshots of the Website and Facebook Page captured by Mr Wooldridge and alleged to contain prohibited representations were set out in the Secretary's submissions: Cancer: "Integrative cancer support. Hyperbaric oxygen is an immune modulation therapy...HBOT may increase the amount of oxygen in cancer cells, which may make them easier to kill with radiation therapy and chemotherapy. HBOT is a type of radiosensitizing agent and a type of chemosensitizing agent...HBOT assists immune responses to chemotherapy reducing immunosuppression and neutropenia." AIDS/HIV: "to establish HBOT as an adjunctive care for children & adults suffering the effect of AIDS. It is our vision that mobile shipping containers housing small multiplace chambers can be specifically located via truck or helicopter into remote regions to assist communities impacted by the devastating effects of AIDS." Depression: "Depression - Oxymed Hyperbaric Oxygen Therapy Tier... (quoting an article) "conclusions: our results suggest that HBOT may ameliorate Traumatic Brain Injury (TBI)-induced depression-like behaviour in rats by attenuating neuroinflammation, representing one possible mechanism by which depression-like behaviour recovery might occur. We also recommend HBO as a potential treatment for TBI-induced depression-like behaviour if early intervention is possible" Post-traumatic stress disorder: (quoting an article) "Hyperbaric Oxygen ameliorates worsening signs and symptoms of post-traumatic stress disorder… We propose that hyperbaric oxygen was effective in improving the patient's neuropsychiatric symptoms by reducing cerebral oxidative stress, inflammation, vasogenic edema, and hippocampal neuronal apoptosis." 122 Each of HIV/AIDS, neoplastic disease (cancer) and mental illness (depression and post-traumatic stress disorder) are conditions which are expressly listed in s 30 of the TG Advertising Code and as such the representations which refer to them fall within the meaning of prohibited representations for the purposes of s 42DLB(2) of the TG Act. 123 At no time during the Relevant Period did Oxymed or Mr Hooper have permission from the Secretary to make prohibited representations on the Website or Facebook Page. No exemptions under s 42AA of the Act apply to the conduct of Oxymed and Mr Hooper. 124 The Respondents admit that they advertised the HBOT devices, or caused the HBOT devices to be advertised in circumstances where those advertisements contained references to prohibited representations within the meaning of s 30 of the TG Advertising Code for the purpose of r 6B(1)(b) of the TG Regulations and therefore within the meaning of s 42DJ(1) of the TG Act. 125 Although Oxymed and Mr Hooper submit that the Website was for "educational purposes", it was available to the general public without restriction. It was not directed exclusively to medical practitioners, persons engaged in the business of wholesaling therapeutic goods, naturopaths, and other homeopathic practitioners, or advice or information directly provided to a patient from a medical practitioner.

APPLICABLE PRINCIPLES 126 The general principles applicable to pecuniary penalties were not in dispute. 127 The principal object of a civil penalty is deterrence: both specific deterrence of repetition of the conduct by the contravener and, by their example, general deterrence of other would-be contraveners: Australian Building and Construction Commissioner v Construction, Forestry, Mining and Energy Union (2018) 262 CLR 157 at [116] (Keane, Nettle and Gordon JJ). 128 The penalty should not be oppressive, in the sense that it should be no higher than necessary to achieve the object of deterrence: Australian Competition and Consumer Commission v Leahy Petroleum Pty Ltd (No 2) (2005) 215 ALR 281 at [9]. However, the amount must be fixed with a view to ensuring that the penalty is not such as to be regarded by the contravener or others as an acceptable cost of doing business: Singtel Optus Pty Ltd v Australian Competition and Consumer Commission (2012) 287 ALR 249 at [62]. 129 Section 42Y of the TG Act empowers the Court to impose a pecuniary penalty on a person found to have contravened a civil penalty provision of the TG Act. The section sets out four relevant matters to which the Court must have regard in determining the pecuniary penalty: (a) the nature and extent of the contravention; and (b) the nature and extent of any loss or damage suffered as a result of the contravention; and (c) the circumstances in which the contravention took place; and (d) whether the person has previously been found by the Court in proceedings under this Act to have engaged in similar conduct. 130 The factors set out in the section do not exhaust all relevant matters for consideration, but they do indicate the considerations to which Parliament turned its attention. In Trade Practices Commission v CSR Ltd [1991] ATPR 41-076 at 52,152, in considering an analogous penalty provision (s 76) of the Trade Practices Act 1974 (Cth), French J (as he was then) drew together from the cases a checklist of factors for consideration in addition to those expressly mentioned in the legislation. The factors have been endorsed by the Full Court in NW Frozen Foods Pty Ltd v ACCC (1996) 71 FCR 285 at 292 and in Pattinson v Australian Building and Construction Commissioner [2020] FCAFC 177 at [99]-[100] (Pattinson). Relevantly, the factors are: 1. The nature and extent of the contravening conduct. 2. The amount of loss or damage caused. 3. The circumstances in which the conduct took place. 4. The size of the contravening company. 5. The degree of power it has, as evidenced by its market share and ease of entry into the market. 6. The deliberateness of the contravention and the period over which it extended. 7. Whether the contravention arose out of the conduct of senior management or at a lower level. 8. Whether the company has a corporate culture conducive to compliance with the Act, as evidenced by educational programs and disciplinary or other corrective measures in response to an acknowledged contravention. 9. Whether the company has shown a disposition to co-operate with the authorities responsible for the enforcement of the Act in relation to the contravention. 131 The Full Court in Pattinson noted at [99] that these factors should not be treated as a rigid catalogue or legal checklist of matters to be applied in each case; rather they are judicial descriptions of likely relevant considerations applicable to the task of coming to an appropriate penalty in the circumstances of varied cases. However, the Full Court went on to acknowledge at [100] that: The setting out of such factors is of assistance, however, in not only capturing relevant matters, but also in providing the necessary focus: that it is to the contravention in question to which the penalty is directed. This is … because the contravention (and its nature, quality and seriousness) must be considered and understood such that the appropriate penalty be imposed to deter such a contravention in the future. 132 The Court should weigh all relevant circumstances to arrive at an appropriate penalty to deter, whilst not being oppressive. As the Full Court in Pattinson noted at [100], the imposition of an appropriate penalty, given the object of deterrence, does not authorise and empower the imposition of an oppressive penalty that is one that is more than is appropriate to deter a contravention of the kind before the court. 133 Attention should also be paid to the maximum penalty for each contravention because it shows the penalty for the worst possible case, and enables comparison with the case at hand, providing, when balanced with all other relevant factors, a yardstick: Markarian v The Queen (2005) 228 CLR 357 at [31] (Markarian). 134 Determination of an appropriate penalty amount is not an exact science. There is no scientific approach or mathematical formula to be applied. The Court should not adopt a mathematical approach of increments or decrements from a pre-determined range, or assign specific numerical or proportionate value to the various relevant factors: Wong v The Queen (2001) 207 CLR 584 at [74]-[76] (Gaudron, Gummow and Hayne JJ). The Court's assessment of the appropriate penalty is a discretionary judgment, an "instinctive synthesis", based on all relevant factors including balancing many different and conflicting features: Markarian at [37].

Peptides and Evolution 135 While acknowledging the limited utility of comparisons with other penalty cases, the parties referred to two recent cases concerning civil penalties under s 42DLB of the TG Act: Secretary, Department of Health v Peptide Clinics Australia Pty Ltd [2019] FCA 1107 (Peptides), and Secretary, Department of Health v Evolution Supplements Australia Pty Ltd (No 2) [2021] FCA 872 (Evolution). Both cases were not defended and substantial penalties were awarded ($10 million and $11 million respectively). As both parties sought to highlight similarities and differences in the present case to these cases, it is useful to briefly summarise the cases. 136 In Peptides the Secretary sought penalties in respect of social media (website, Facebook pages and Instagram) advertisements for peptides which were Schedule 4 substances, meaning they can only be supplied on prescription. The impugned conduct extended over a 12-month period. At the time of the hearing the respondent was in liquidation and had ceased trading. 137 In addition to the social media advertising, the Peptide Clinics business model changed over time to include an online medical questionnaire which was allegedly reviewed by a medical practitioner who would contact the customer. Following that, a Peptide Clinics representative would telephone the customer to explain the costs of the goods and take the order. 138 The medical evidence set out at [13] was that with the exception of one compound (Minoxidil for hair loss) there was no medical justification for using the peptides to treat the so-called "conditions" that were listed on the Peptide Clinics website. The risks of taking such substances for the conditions were described as "completely unacceptable". 139 The contraventions had a wide reach, with Peptide Clinics advertising that it had 50,000 satisfied patients. The cost of the peptides sold ranged from $99.95 to $1,399.85. Justice Jagot accepted at [39] the Secretary's submission that "Peptide Clinics has deliberately and recklessly pursued its own financial self-interest at the expense of its legal obligations and the interests of public health". 140 At [12] and [43], Jagot J accepted the Secretary's submission that a contravention occurred on each day the advertising appeared on the digital platforms. The different advertisements contravened the applicable provisions of the TG Act "from day to day". Annexure 3 to her Honour's reasons sets out a total of 19,850 contraventions, with a potential total statutory maximum penalty of over $200 billion. 141 At [41] Jagot J accepted the Secretary's submissions that Peptide Clinics was obstructionist, that it did not co-operate with the Secretary in the course of the proceedings, and that the Court could infer that it had no intention of complying with its obligations under the TG Act unless it was forced to do so. 142 At [44] Jagot J accepted a "course of conduct" approach which described the conduct as involving nine separate courses of conduct which were set out in Appendix 3 to her Honour's reasons. At [44] the penalties for the nine courses of conduct totalled $20 million. After having regard to the totality principle her Honour considered that a penalty in the sum of $10 million was appropriate, accepting that it was no longer necessary to consider specific deterrence, but noting that a penalty of that size would secure the objective of general deterrence, by sending a message that companies will not be able to profit from their wrongdoing. 143 The second penalty case concerning s 42DLB of the TG Act is Evolution. This was a penalty hearing which followed from a hearing as to liability: Secretary, Department of Health v Evolution Supplements Australia Pty Ltd [2021] FCA 74. The respondents did not appear at either hearing. 144 The respondents advertised supplements on their website. For a four-month period they also advertised the supplements for sale on their "after hours" website which only operated between 8pm and 4am. 145 There were 97 impugned supplement products. Some of the supplements contained ingredients listed on Schedule 4 and/or Schedule 10 of the Poisons Standard. Some supplements did not contain ingredients from Schedules 4 or 10, but nevertheless were not registered on the ARTG. 146 Schedule 4 substances are substances which may be entered on the ARTG but which should only be used or supplied pursuant to a prescription from an appropriately qualified professional. The medical evidence was that the use of the Schedule 4 substances presented a serious risk to human health and safety and had a high risk of adverse effects. 147 Schedule 10 substances are substances that are not appropriate for entry on the ARTG. The medical evidence was that the use of Schedule 10 substances in supplements and stimulant products constituted a serious risk to human health. For example, evidence regarding one compound (1,3 dimethylamylamine) showed that it was considered a toxic substance without known health benefits, and that taking it could result in raised blood pressure, psychiatric disorders, bleeding on the brain and cardiovascular problems ranging from shortness of breath to heart attack. 148 Justice Burley noted that the respondents had received a "first warning letter" from the TGA in December 2018, and from that date the respondents were on notice of the Secretary's concerns. Thereafter followed a series of correspondence from the TGA outlining the alleged contraventions. 149 On 23 October 2019, after receiving the TGA's correspondence, the respondents set up the after-hours website, which his Honour described at [43] as "a form of subterfuge engaged in [by the respondents] in an attempt to avoid the scrutiny of the Department". 150 The total number of contraventions alleged by the Secretary was 13,103, comprising 8,929 on the website and 4,174 on the after-hours website. The advertising took place over a 12-month period. 151 At [60] Burley J accepted the Secretary's submissions that each day on which an advertisement for one of the impugned products remained on the website or after-hours website amounts to a separate contravention of the TG Act, and that the number of days for which an advertisement is published should be inferred from the first date on which it appears in the evidence until the last date on which it appears in the evidence. 152 At [61] Burley J stated that the appropriate way of understanding how many times Evolution "advertised" on the website and after hours website and therefore understanding the number of contraventions of s 42DLB(1), lies in determining "on how many occasions was the information about the products in question sought to be made known to the public". His Honour concluded that occurred every day the advertisement remained published. 153 Justice Burley noted that applying the maximum penalty to the number of contraventions gave an "eye-watering" conclusion that the total penalty would exceed $137 billion. His Honour concluded at [62] that "plainly, it was not appropriate to apply this approach literally in the present case". 154 Instead Burley J accepted at [64] that Evolution's conduct could be described as involving eight courses of conduct. Such an approach allowed differentiation of the seriousness of the contraventions and the conduct of advertising on the website which could logically be distinguished from the after-hours website, as the latter was coloured by the fact it was implemented in an attempt to avoid detection of contravening behaviour. 155 Justice Burley accepted at [85] that penalties should be imposed by reference to the eight separate courses of contravening conduct. In considering the appropriate penalty Burley J noted nine relevant considerations, including at [75] that the contraventions formed part of a deliberate marketing strategy; at [76] that the conduct associated with the after-hours website was "contumelious"; and at [82] that given Evolution was the subject of a Notice of Proposed Deregistration it seemed that the role of specific deterrence would be minimal. 156 At [86] Burley J determined that the penalties for the eight courses of conduct totalled $13.5 million. After having regard to the totality principle his Honour considered that a penalty in the sum of $11 million for Evolution was appropriate. The director of Evolution was separately penalised $1 million.

Quantifying the contraventions 157 The Secretary submitted that there have been many breaches of the civil penalty provisions of Part 5-1 of the TG Act by Oxymed and Mr Hooper. Annexure 1 to the Secretary's submissions provided a summary table of the number of instances in which the Respondents engaged in conduct involving a civil penalty under the TG Act. The Secretary's methodology considered each of the following to be a unique contravention: (a) each reference to a condition, ailment or disease that was a restricted representation or prohibited representation (so, in the case where one advertisement referred to several conditions, each reference would be included as a unique contravention); (b) each advertisement of HBOT devices on the Website and Facebook Page; and (c) each day that a reference or advertisement of the kinds in (a) and (b) above appeared on the Website or Facebook Page. 158 On the Secretary's analysis the total number of unique contraventions is 1851. Applying the maximum penalty for each contravention, the maximum potential pecuniary penalty for 1851 breaches of s 42DLB(1) is over $19 billion, an "eye-watering" figure. 159 The Respondents reject the Secretary's classification of unique contraventions, and therefore the calculation of the maximum aggregate penalty based on that classification. 160 Instead, the Respondents submit that each unique post on the Website or Facebook Page constitutes a single contravention, irrespective of how many conditions were referred to in the post, or how long the post remained accessible to the public. On this analysis, the Respondents contend there are 176 unique contraventions. They submit that their approach is supported by a proper reading of the TG Act. 161 According to the Respondents, the Secretary's approach creates a "continuing contravention" in circumstances where there is no clear legislative intent in the TG Act for that mode of charge for contraventions of s 42DLB. In the Respondents' submission there is nothing in s 42DLB which suggests that a contravention of the section is intended to be a daily or continuing contravention. 162 A continuous or continuing offence is a concept well known in criminal law which is often used to describe two different kinds of crime. The Victorian Court of Appeal in Ex parte Barelli's Bakeries Pty Ltd [1965] VR 615 at 620 explained: There is the crime which is constituted by conduct which goes on from day to day and which constitutes a separate and distinct offence each day the conduct continues. There is on the other hand, the kind of conduct, generally of a passive character, which consists in the failure to perform a duty imposed by law. Such passive conduct may constitute a crime when first indulged in but if the obligation is continuous the breach though constituting one crime only continues day by day to be a crime until the obligation is performed. … The question whether an offence is of a continuing or continuous nature generally arises in the case of statutory offences and the question is solved by ascertaining what is the precise nature of the offence. 163 Oxymed and Mr Hooper submit that their conduct in posting material on the Website and Facebook Page and leaving it available on the Website and Facebook Page is akin to the second type of continuing offence described in Ex parte Barelli's Bakeries, where the conduct is of a passive character, which might constitute an offence when first indulged in, but which does not constitute a new offence each day. 164 Continuing and continuous civil and criminal offences are found in the TG Act. For example, ss 42DL(13) and (14) expressly provide that a separate offence is committed each day that certain criminal offences occur, and s 42YCA expressly provides for continuing contraventions of certain civil penalty contraventions. The Respondents submit that s 42DLB is to be contrasted with those sections, in that where a section is silent as to whether a contravention is to be treated as a continuing contravention, a continuing contravention should not be implied. 165 Section 42DL is found in the same part of the TG Act as s 42DLB and imposes criminal sanctions for advertising offences (including restricted and prohibited representations). It expressly contemplates continuing offences. For example, s 42DL(2) provides a person commits an offence if s 42DL(5) (relating to prohibited representations) applies to the advertisement. The penalty for the offence is either or both of 12 months' imprisonment or 1000 penalty units. 166 Under the heading "continuing offences", s 42DL(13) provides that: a person who contravenes subsection (1), (2) or (3) commits a separate offence in respect of each day (including a day of a conviction for the offence or any later day) during which the contravention continues. 167 Subsection 42DL(14) provides that the maximum penalty for each day that an offence against subsection (1), (2) or (3) continues is 10% of the maximum pecuniary penalty that can be imposed in respect of that offence. 168 Section 42CA relates to continuing contraventions of civil penalty provisions. Subsection 42YCA(2) provides that a person who contravenes a civil penalty provision that requires an act or thing to be done: (a) within a particular period; or (b) before a particular time; commits a separate contravention of that provision in respect of each day during which the contravention occurs. 169 On the other hand, s 42DLB does not contain any express provision that a person who contravenes the section commits a separate contravention in respect of each day during which the contravention continues. In the absence of an express reference, the Respondents submit that it should not be implied that s 42DLB contemplates a separate contravention in respect of each day during which a contravention continues. 170 Oxymed and Mr Hooper sought to illustrate the illogicality of the Secretary's construction that s 42DLB contemplates a separate offence for each day with the example of a social media post made at 11.59 pm one day and taken down at 12.01 am the next day. On the Secretary's construction, that post that was up for two minutes would constitute two separate contraventions, potentially attracting a maximum penalty of $22.2 million. 171 Oxymed and Mr Hooper's construction of s 42DLB has some merit. As they submit, the terms of s 42DLB do not expressly provide for any continuing contravention, whereas other sections in the TG Act expressly contain such a provision. As noted above, the advertising criminal penalty section (s 42DL) contemplates a continuing contravention, with the daily penalty set at 10% of the total. 172 The "eye-watering" maximum aggregate penalty amounts calculable for internet and social media posts left up for any length of time, such as those in Peptides and Evolution, or even potentially for a few minutes, also tends against a construction of s 42DLB as providing for a continuing offence. 173 However, even on Oxymed and Mr Hooper's construction, the number of contraventions is still large (176) and the maximum aggregate penalty (over $187 million) is still a number well beyond what this Court would ever impose in this case (see, eg, Australian Competition and Consumer Commission v Coles Supermarkets Australia Pty Ltd [2015] FCA 330 at [82] (ACCC v Coles)), so it is not necessary in this case to resolve the conflicting constructions.

Course of Conduct 174 Australian Competition and Consumer Commission v Turi Foods Pty Ltd (No 5) [2013] FCA 1109 was a case that also involved a potentially vast number of individual contraventions. At [23] Tracey J recognised that the authorities have cautioned against the adoption of an analysis based on calculating a maximum aggregate penalty based on the many individual contraventions and have developed principles which temper the severity of such an approach. 175 Where there are a multitude of contraventions, and especially where the literal calculation of the maximum aggregate penalty gives a penalty of a size that the court would not order, the Court may adopt a course of conduct analysis to group together the contraventions to avoid the risk of double punishment. 176 In Australian Building and Construction Commission v Construction, Forestry, Mining and Energy Union (2017) 254 FCR 68 (ABCC v CFMEU) the Full Court said at [115]: The course of conduct principle has been applied in the civil pecuniary penalty context… The principle has also been consistently applied despite the fact that it is largely based on the need to avoid double punishment, whereas, as discussed earlier, the primary, if not sole, purpose of imposing a pecuniary penalty is said to be to deter, not to punish. There would also appear to be cases where the Court has, purportedly pursuant to the course of conduct principle, grouped together separate contraventions which were considered to be part of a single course of conduct and imposed a single penalty for that course of conduct. 177 In a case such as this with multitudes of contraventions to consider, it can be appropriate to adopt a course of conduct approach in order to ensure that the contravener is not punished multiple times for the same type of contravention. The course of conduct approach was adopted in both the Peptides and Evolution cases, which reduced the multitudes of contraventions down to 9 and 8 courses of conduct respectively. In both cases the Court then applied the totality principle to reach an appropriate penalty. 178 The course of conduct approach had the support of the Secretary. In oral submissions, senior counsel for the Secretary "expressly foreswore" suggesting that a calculation of maximum aggregate penalty be undertaken based on the large number of individual contraventions alleged by the Secretary. Instead the Secretary proposed an alternate calculation of the pecuniary penalty based on six courses of conduct said to characterise the contravening conduct by Oxymed and Mr Hooper over the Relevant Period. 179 The course of conduct breakdown proposed by the Secretary for the contraventions of s 42DLB(1) of the TG Act, together with the proposed penalty sought by the Secretary for each was as follows: (a) advertising HBOT Devices on the Website where s 42DLB(9) applies: $3.8 million; (b) advertising HBOT Devices on the Facebook Page where s 42DLB(9) applies: $2.1 million; (c) advertisements containing Restricted Representations on the Website where s 42DLB(4) applies: $5 million; (d) advertisements containing Restricted Representations on the Facebook Page where s 42DLB(4) applies: $2.9 million; (e) advertisements containing Prohibited Representations on the Website where s 42DLB(2) applies: $4.2 million; and (f) advertisements containing Restricted Representations on the Facebook Page where s 42DLB(2) applies: $900,000. The proposed sums total $18.9 million.

Totality Principle 180 In determining the appropriate penalty, it is also relevant to take into account the "totality principle", which provides that the total penalty for related contraventions ought not to exceed what is proper for the entire contravening conduct involved: TPG Internet Pty Ltd v Australian Competition and Consumer Commission (2012) 210 FCR 277 at [142]. 181 The totality principle, like the course of conduct principle, has its origins in criminal sentencing. Middleton J discussed the application and rationale for the totality principle in civil penalty cases in Australian Competition and Consumer Commission v Telstra Corporation Limited [2010] FCA 790 at [229]-[230]: Application of the totality principle requires the Court to review the entirety of the conduct and to determine whether the proposed penalty is appropriate 'as a whole'. The purpose of the exercise is to ascertain whether the proposed penalty is just and appropriate for the entirety of the contravening conduct, looking at the degree of misconduct involved. The rationale underlying the totality principle is to ensure that the proposed penalty is not out of proportion with the conduct giving rise to the contraventions when viewed collectively, and to ensure the penalty is accordingly just and appropriate from the perspective of that collective assessment 182 The Full Court in ABCC v CFMEU noted at [117] that the totality principle is sometimes confused or conflated with the course of conduct principle: That is perhaps not surprising because application of the totality principle may again result in a court adjusting what would otherwise have been consecutive or cumulative sentences to sentences that are wholly or partially concurrent. The proper approach, however, is to first consider the course of conduct principle and determine whether the sentences should be consecutive, or wholly or partly concurrent. Once that is done, the Court should then review the aggregate sentence to ensure that it is just and appropriate. That may require a further adjustment of the sentences: either by ordering further concurrency or, if appropriate, lowering the individual sentences below what would otherwise be appropriate. 183 The Court will generally have regard to the totality principle as a final consideration of whether the cumulative total of the penalty is just and appropriate and in proportion to the contravening conduct considered as a whole: Australian Securities and Investments Commission v Westpac [2019] FCA 2147 at [272] and [308]. 184 The totality principle will not always or necessarily result in a reduction of the penalty that would otherwise be imposed. It enables the Court to consider whether the final penalty is in proportion to the nature, quality and circumstances of the conduct involved. In this respect, the totality principle is distinct from the course of conduct principle: Director of Consumer Affairs Victoria v Gibson (No 3) [2017] FCA 1148 at [36]; Australian Competition and Consumer Commission v Bupa Aged Care Australia Pty Ltd [2020] FCA 602 at [58]. 185 The totality principle is a final check to be applied to ensure that a final, total or aggregate, penalty is not unjust or out of proportion to the circumstances of the case: Mornington Inn v Jordan (2008) 247 ALR 714 at [42] (Stone and Buchanan JJ).

Parity 186 Differences in the facts and circumstances which underlie different cases mean there is usually little to be gained by comparing the penalties imposed in other litigation. However, this does not mean that penalties imposed in other cases are never relevant. The parity principle is a doctrine developed in criminal law, the chief purpose of which is to ensure that like offenders are treated in a like manner. Otherwise, the consistency that is sought is "consistency in the application of the relevant legal principles, not some numerical or mathematical equivalence". 187 By application of the parity principle, assessments of penalty in analogous cases may provide guidance to the Court to ensure that there is parity of treatment of similar circumstances. Equality before the law is important. However, as Hill J observed at [34] in Australian Competition and Consumer Commission v Universal Music Australia Pty Ltd (No 2) (2002) 201 ALR 618, while pecuniary penalties imposed in one case provide a guide, that guide will seldom, if ever, be able to be used mechanically. 188 Both parties made reference to three recent civil penalty cases: Peptides, Evolution and Australian Competition and Consumer Commission v Lorna Jane Pty Ltd [2021] FCA 852 (Lorna Jane). Each party sought to highlight similarities or distinguish differences. As Burley J noted at [69] in Evolution, the assessment of penalty by reference to penalties imposed in comparable circumstances should be approached with some caution. The authorities make plain that it is the consistent application of principle that is relevant to the assessment of penalty rather than the range of penalties given in disparate circumstances that cannot be said to be analogous.

Nature and extent of contraventions 189 The Secretary submitted that the contraventions involved numerous breaches of Part 5-1 of the TG Act which regulates the advertising of therapeutic goods and which was introduced to promote the protection of public health. 190 The Secretary emphasised that it is important to keep in mind the purpose of the TG Act. The TG Act establishes a regulatory framework which is intended to protect vulnerable consumers by regulating therapeutic goods and the manner in which they are advertised. The objects as set out in s 4 include the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods in Australia. 191 The Secretary adopted the comments of Burley J in Evolution at [55] that ss 42DLB(1), (7) and (9) in particular provide important support to the regulatory apparatus of the TG Act and the system of registration by proscribing the advertisement of therapeutic goods not entered on the ARTG and that are prescribed by the TG Regulations for the purpose of s 42DLB(9). 192 The Secretary stressed that the requirements of s 42DLB have a consumer protection rationale. The requirements of s 42DLB are said by the Secretary to be integral to the protection of the community, in particular those who are living with chronic conditions which may severely impact on their quality of life. Those people are potentially vulnerable to representations that may give false hope, inflated expectations or wrong impressions, and which may direct such people away from conventional therapies to therapies which are not supported by scientific evidence. Conduct such as that of Oxymed and Mr Hooper undermines the public health objective of the TG Act and its regulatory scheme. 193 The Relevant Period in which the impugned posts were made spanned some six months. The posts were available on two platforms, the Website and the Facebook Page. There was also evidence of posts of a similar nature on Mr Hooper's LinkedIn page in April 2021. 194 The Secretary submitted that the Respondents' posts on the Website and Facebook Page were a deliberate marketing strategy for the purposes of promoting the HBOT services offered by Mr Hooper and Oxymed. The conduct of the Respondents significantly undermined the integrity of the ARTG. 195 The Secretary drew attention to the posts regarding COVID-19 as an example of the Respondents' marketing strategy aimed at the vulnerable and anxious. The COVID-19 posts were made just as the pandemic was starting, with community anxiety rising and Melbourne entering its first lockdown in March 2020. The COVID-19 post made on 20 March 2020 was the subject of one of the TGA Infringement Notices. There were also COVID-19 posts in the April 2021 LinkedIn screenshots. The Secretary compared the Respondents' COVID-19 posts to the COVID-19 claims in Lorna Jane's "LJ Shield" July 2020 advertising campaign, which Rangiah J described as "exploitative, predatory and potentially dangerous" behaviour: Lorna Jane at [19]. 196 Senior counsel for the Respondents sought to downplay seriousness of the COVID-19 posts, by submitting first, that before 3 April 2020, HBOT had no realistic application to COVID-19 as there were not cases in the Australian community at that time who would have attended the Oxymed clinic to be treated. Second, it was put that the posts were almost in the way of being a public service, as the website collated current information from around the world about what was required to treat COVID-19. 197 The Secretary acknowledged that Mr Hooper and Oxymed had accepted that their conduct contravened the TG Act. However, the Secretary noted that the Respondents only took down the posts and ceased posting on the Website and Facebook Page after the TGA served the five infringement notices and the final cease and desist notice. Mr Hooper and Oxymed finally took down the Website after the commencement of proceedings in August 2020. 198 Oxymed and Mr Hooper sought to downplay or excuse their conduct, and their delay in removing the posts from the Website and Facebook Page in three ways. 199 First, as to the non-listing of the HBOT devices on the ARTG, the Respondents relied on Mr Hooper's long held belief that the HBOT devices did not need to be listed on the ARTG. The source of this belief was the letter from the TGA to Mr Zeigler in 1999. 200 Second, the Respondents submitted that the posts on the Website and Facebook Page were an educational resource, and were not intended to be advertisements. Many of the posts were said to refer to Mr Hooper's speaking engagements, or were in the form of links to abstracts and articles about the use of HBOT to treat various conditions. These were said to be "indirect" advertisements. 201 Third, the HBOT treatment the subject of the posts was not harmful to patients. In contrast to the supplements in Evolution and the peptides in Peptides, the HBOT was "benign" and did not itself have a high risk of adverse effects or pose "completely unacceptable" risk to patients. There was no evidence of any actual harm being suffered by a person receiving HBOT. 202 The Secretary did not accept ignorance of the relevant TG Act requirements as an excuse for Oxymed and Mr Hooper's conduct. The Secretary submitted that individuals and companies purveying therapeutic goods and services must be aware of the relevant statutory regulatory regime and ensure that they comply with it. 203 In relation to Mr Hooper's belief that the HBOT device did not need to be registered, the Secretary noted that Mr Hooper's belief was based on one letter that was over 20 years old. The Secretary submitted that the TG Act was overhauled in 2002, after which HBOT devices were required to be registered. It was not acceptable to maintain a belief about a medical device used to treat patients without checking the regulatory regime for almost 20 years. 204 The Secretary rejected the idea that the Website and Facebook Page were an "educational resource". Rather, the Secretary submitted that Oxymed and Mr Hooper sought to promote HBOT and bolster the credibility of HBOT as a treatment for a variety of conditions by linking to scholarly or pseudo-scholarly articles and abstracts, and details of Mr Hooper's speaking engagements. 205 As to the harm, the Secretary relied on the evidence of the medical experts that there was a risk of harm where a person avoided orthodox evidence-based treatment for their condition in favour of pursuing HBOT, as well as the risk of financial harm from the cost of a course of HBOT. The Secretary said evidence as to potential harm was sufficient and that no evidence of specific harm was required, referring to Jagot J in Peptides at [37].

Scale and reach of conduct 206 The Secretary submitted that the internet is a mechanism by which information can be made available to the world at large, and that the posts on the Website and Facebook Page had the potential to reach many vulnerable people. 207 The Respondents submitted that there was no evidence as to the reach of the advertisements, such as traffic to the site or the likely search process and ease by which a consumer might find the Website or Facebook Page. This was to be contrasted with the 50,000 "patients" in Peptides. For that reason, the Respondents submitted that no consideration could be given to whether the dissemination of the advertisements on the Website was widespread or not.

Nature of any specific loss and damage 208 As to the nature of any specific loss or damage caused by the contraventions, there was no evidence of any actual loss or damage. 209 The Secretary relied on Professor Bennett's and Dr Brownscombe's evidence that there was potential for financial loss to patients as well as potential risk of physical harm. Vulnerable patients influenced to pursue HBOT by the advertisements for conditions where the effectiveness of HBOT is not supported by current scientific evidence may lose money paying for multiple sessions of expensive HBOT. HBOT sessions at the Oxymed clinic cost $129.59 per hour during the Relevant Period. Furthermore, the Website screenshots, and QS's experience in the VCAT Proceedings, suggest it was common for HBOT treatment courses to add up to many hours in duration. 210 Based on Professor Bennett's evidence, the Secretary submitted that the unrealistic expectations and false hope that HBOT would be efficacious engendered by the Respondents' advertisements had the potential to cause patients to pursue HBOT to the exclusion of orthodox evidence-based medical treatment for their condition. 211 The Respondents submitted that the present case ought to be contrasted with Evolution and Peptides, in that HBOT was described by Professor Bennet as "relatively benign", while the other cases involved products which presented a high risk of adverse effects, and posed a danger to human health. The risks of taking the substances in Peptides were described by one expert as "completely unacceptable". 212 Mr Hooper and Oxymed relied on Professor Bennett's evidence that HBOT was "relatively benign" and that some people feel better after their HBOT to submit that this case lay far from Peptides and Evolution at the low end of the potential for harm.

Circumstances in which the contravention took place 213 As noted above, Mr Hooper and Oxymed submitted that the posts on the Website and Facebook Page were intended as an educational resource, and were not intended to be advertisements. The Secretary rejected that submission, instead submitting that the posts formed part of a marketing strategy in which the links to pseudo-scientific articles and Mr Hooper's speaking engagements were intended to enhance the credibility of HBOT as a treatment, and of Oxymed and Mr Hooper as providers of that treatment. 214 Also as discussed above, Oxymed and Mr Hooper relied on Mr Hooper's belief that the HBOT devices did not need to be registered to excuse their posts about HBOT devices. They also sought to explain their delay in accepting the advertisements contravened the TG Act and removing the posts was due to the complexity of the legislation and the regulatory scheme for advertising therapeutic goods established under the TG Act. 215 The Secretary rejected the idea that the legislation was complex, and submitted that the purveyors of therapeutic goods and services need to be aware of the applicable regulatory regime and keep abreast of the requirements. It is incumbent upon any business seeking to supply health treatments or services using therapeutic goods to be aware of their obligations under the TG Act and its regulatory framework. In those circumstances reliance on a letter over 20 years old could not provide an excuse.

Previously found in proceedings under the TG Act to have engaged in similar conduct 216 It is common ground that Oxymed and Mr Hooper have not been found to have engaged in similar conduct under the TG Act.

Size and financial position of contravening company 217 The Respondents relied heavily on the small size and limited financial position of Oxymed as a basis for their submission that the penalty should be at the very low end of the range, as otherwise a penalty in the range sought by the Secretary would be "crushing and oppressive". 218 The Respondents submitted that the capacity of a contravener to pay must be a relevant factor in assessing an appropriate penalty, otherwise the penalty would be unmoored to the principle of proportionality. They further submitted that a penalty of the magnitude sought by the Secretary would be in effect be meaningless as Oxymed would be "exterminated". 219 The Respondents' counsel likened Mr Hooper and Oxymed to the sole proprietor of tea shoppe with a sign in the window spruiking the health benefits of peppermint tea. This, according to the Respondents, was to be contrasted with multinational pharmaceutical companies which are also regulated by the TG Act, and it should be inferred that the maximum end of the penalty scale was intended to provide deterrence for that size of company. 220 The Secretary submitted that Oxymed's gross profit for 2019-20 financial year was in excess of $470,000. During the Relevant Period, Oxymed's turnover from HBOT services, which formed approximately 91% of its business, was $323,204.

Deliberateness of the contravention and the period over which it extended 221 The Secretary characterised Oxymed and Mr Hooper's conduct as a deliberate decision to emphasise profit over proper regard for public safety. 222 As noted above the Respondents sought to minimise their conduct by portraying the Website as an educational resource for consumers and health practitioners. Whether the contravention arose out of the conduct of senior management 223 The contravening posts on the Website and Facebook Page were made by Mr Hooper, the sole director of Oxymed and the person responsible for managing the day to day operations of the clinic during the Relevant Period.

Co-operation with authorities 224 The Respondents admitted to having posted the advertisements referred to in the SAFA Schedules on the Website and Facebook Page, and that the advertisements constituted contraventions of s 42DLB(1) of the TG Act. 225 The Respondents submitted that their admission that the posts on the Website and Facebook Page constituted contraventions saved the cost and expense of a trial on liability. They submitted that their admissions were "akin to a guilty plea" in criminal law and had benefit for the community and the Court in facilitating the course of justice. As with a sentencing discount with a guilty plea, in their submission, Mr Hooper and Oxymed's early acceptance of their contravening conduct should be taken into account in determining the penalty. 226 The Secretary acknowledged the acceptance of liability on the part of Mr Hooper and Oxymed, but noted that it did not take place at the first opportunity. 227 The Respondents submitted that their delay in ceasing the conduct was not indicative of a willingness on their part to breach the law. Rather, the Respondents submitted that the delay was reasonable, characterising the delay as being due to Mr Hooper engaging with the TGA as he was entitled to do, trying to grapple with the law (which counsel for the Respondents described as "labyrinthine" and difficult to navigate), and getting clarity as to the allegedly contravening conduct.

Whether conduct was deliberate, systematic or covert 228 Unlike the after-hours website in Evolution, the Respondents' conduct was not covert. 229 The TGA expressly warned in its 4 June 2018 letter that the Respondents' failure to review or amend their advertising behaviour may be taken as a deliberate decision to engage in the contravening conduct or, at the very least, to disregard the applicable regulatory regime and its requirements.

Need for specific deterrence 230 The Respondents' senior counsel conceded that the VCAT Proceedings had some relevance to the requirement of specific deterrence. 231 It would be fair to say from the VCAT reasons and a review of the Website and Facebook Page posts that Mr Hooper has long-held and strong beliefs when it comes to the utility of HBOT as a panacea for the treatment of many and varied conditions. Other than in the four examples given by Professor Bennett, there is no, or insufficient scientific evidence to support the use of HBOT for the conditions listed in Schedules A and B. 232 I discuss the need for specific deterrence, especially in the case of Mr Hooper below.

Other factors 233 Despite Justice Beach's order of 24 August 2020, the Website was put back online without the Secretary's consent some time before 18 January 2021. 234 Further, posts about the utility of treating diseases and conditions such as COVID-19 with HBOT were visible on Mr Hooper's LinkedIn page after the signing of the SAFA on 14 April 2021. 235 On each occasion the Secretary brought the conduct to the attention of Mr Hooper and Oxymed, and the posts were taken down.

PENALTY 236 I consider that it is appropriate to adopt a course of conduct approach in this case, rather than to calculate a penalty based on the number of contraventions, as even on the lower figure propounded by Oxymed and Mr Hooper the maximum aggregate penalty is still an eye-watering figure, beyond what the Court would consider awarding in this case. 237 I am not satisfied that there is sufficient difference between the Website and Facebook Page postings to treat them as separate courses of conduct as submitted by the Secretary. The two are interconnected. The Facebook Page posts provide links to the Website. Both are a similar internet based advertising medium, as opposed to a newspaper advertisement, billboard or television advertising. 238 I consider that the appropriate way to proceed in this case is to view the conduct as comprising three courses of conduct, based on the three classes of representation made which align with the three types of contravention: the unregistered HBOT representations to which s 42DLB(9) of the TG Act applies; the Restricted Representations to which s 42DLB(4) applies; and the Prohibited Representations to which s 42DLB(2) applies. 239 I also note that many of the unique posts or advertisements contained several contravening representations. Additionally, many of the unique posts were similar in substance. 240 As to the nature and extent of the contravention, it is important to keep in mind the objects and purpose of the TG Act and its role in protecting vulnerable consumers by establishing a system to regulate therapeutic goods and services. 241 Oxymed and Mr Hooper are not the internet equivalent of the local tea shoppe with a hand written sign in the window spruiking the benefits of peppermint tea. Whilst there is no evidence as to the extent of dissemination (unlike in Peptides), such as the number of visits to the site, the Website and Facebook page are aimed at a vulnerable audience, untutored in science, and many seeking relief from living with chronic conditions, or the carers, friends and relatives of such people. 242 The deluge of posts and links to "scientific" articles, testimonials from satisfied customers, and Mr Hooper's speaking engagements on the Website and Facebook Page is intended to engender in the unscientifically trained and vulnerable reader a perception of credibility as to the claims of HBOT as a treatment for the conditions set out in Schedules A and B. As the expert evidence established, Oxymed and Mr Hooper were advertising the use of HBOT for the treatment of a range of conditions, for most of which the use of HBOT was not supported by scientific evidence. 243 Even if not "deliberate", Mr Hooper and Oxymed have a practice of posting pseudo-scientific articles targeted at a vulnerable audience. Perhaps this is best illustrated by the posts relating to COVID-19 which appeared in March 2020, just as community anxiety was building as to this new pandemic, and which despite being removed from the Website and Facebook Page were subsequently found on Mr Hooper's LinkedIn page in April 2021. 244 It is apparent from the reasons from the VCAT Proceeding that Oxymed is not Mr Hooper's first time operating an HBOT clinic and advertising the use of HBOT to treat various diseases and conditions. Oxymed was incorporated in 2015. Oxymed and Mr Hooper should have been aware of, and concerned to comply with, the relevant regulatory scheme that applied to the provision of HBOT from the day that they commenced supplying HBOT, if not before. 245 In any event, the TGA sent a warning letter about the posts on the Website and Facebook Page in May 2018 which drew attention to the relevant TG Act provisions. Oxymed and Mr Hooper were given an opportunity to change their conduct but they did not avail themselves of this opportunity. 246 Since at least 2002, the HBOT devices used to provide the HBOT have been required to be registered on the ARTG. It is stretching credibility to maintain a belief as to non-registrability based solely on a letter that is over 20 years old. It is extraordinarily cavalier to maintain an ignorance as to the applicable statutory scheme and regulatory regime whilst operating a clinic providing HBOT to patients using therapeutic goods. 247 I acknowledge that Oxymed and Mr Hooper have admitted that the posts on the Website and Facebook Page constitute contraventions of the TG Act, and the savings to the taxpayer that ensue in avoiding a trial as to liability. However, as was submitted by the Secretary, the admissions were not made at the first opportunity. I do not accept that the Respondents' delay can, or should be, excused as they needed to "come to grips" with the "labyrinthine" scheme of the TG Act. In any event the advertising conduct and the relevant TG Act provisions were first brought to the attention of Mr Hooper and Oxymed in May 2018, over two years before proceedings were commenced. 248 Whilst Mr Hooper and Oxymed ultimately conceded their conduct contravened s 42DLB of the TG Act prior to the trial, at the time they filed their defence in December 2020, the Respondents continued to deny that the HBOT devices were "medical devices" or "therapeutic goods" within the meaning of the TG Act, and that their postings constituted restricted or prohibited representations. 249 Oxymed and Mr Hooper were first notified by the TGA that their posts on the Website and Facebook Page were alleged to be in contravention of s 42DLB in May 2018. This communication from the TGA specifically drew attention to the requirement for the HBOT devices to be registered on the ARTG and attached "relevant legislative extracts" from the TG Act and the TG Advertising Code. 250 A cease and desist letter, five infringement notices and a final cease and desist letter did not stop the Respondents' conduct. It was only after the commencement of proceedings and the close of pleadings that the Respondents accepted their conduct as contravening. 251 It is the responsibility of anyone who wishes to engage in a business which involves the use of therapeutic goods or the provision of health services to be aware of the applicable statutory scheme, the conduct that is prohibited, and to comply with the relevant regulatory requirements established under the TG Act, from the time they start the provision of those services, if not before. 252 Even if Mr Hooper and Oxymed were ignorant as to the requirements under the TG Act, some three years after the incorporation of Oxymed, the May 2018 letter from the TGA should have put them on notice that there were regulatory requirements and that the TGA considered that they were in contravention of those requirements. There was no explanation as to why no enquiry had been undertaken as to regulatory requirements in the almost two year period between the warning in May 2018 and the issuing of the infringement notices in March 2020, other than the 'labyrinthine' complexity of the regulatory scheme. 253 The object of specific deterrence is very important in this case as regards to Mr Hooper, less so in the case of Oxymed, which has one issued $1.00 share, and as submitted by its senior counsel, is unlikely to survive a penalty anywhere near the range sought by the Secretary. 254 It is clear that Mr Hooper is an enthusiastic believer (VCAT referred to him as a "devotee") in the utility of HBOT for treating many conditions, including those in Schedules A and B to the SAFA. It is also clear that his belief is longstanding. For example, in his letter dated 31 May 2018, Mr Hooper refers to "23 years of clinical operation of our 4-chambers". Additionally, Mr Hooper's April 2021 LinkedIn page states: Malcolm Hooper is an 'influencer', founder and clinical director of OXYMED Australia (formerly HyperMED) where during some twenty five years he gained international renown for providing the wider 'off-label' applications of Hyperbaric Oxygenation. 255 Mr Hooper, the sole director of Oxymed, was responsible for all content that was published on the Website and Facebook Page (and I infer his LinkedIn page) and had oversight and authority over what was included or excluded from the Website and Facebook Page (and I infer again, his LinkedIn page). 256 Mr Hooper has been posting on the internet and social media on behalf of Oxymed about the utilities of HBOT for treating a wide range of various conditions since at least 2018, when the TGA sent its first warning letter in respect of the posts on the Website and Facebook Page, and possibly longer. 257 The reasons in the VCAT Proceedings describe conduct very similar to the conduct the subject of this proceeding. The VCAT Proceedings against Mr Hooper, at that time the sole director of HyperMED and in control of the posts on the HyperMED website, involved posts on the HyperMED website as to "Disorders treatable with HBOT". The list of disorders in the VCAT Proceedings substantially overlaps with the conditions listed in Schedule A to the SAFA. 258 Whilst restrained from posting advertisements about the utility of HBOT to treat diseases and conditions by the orders of Beach J dated 24 August 2020 and 28 September 2020, advertisements of that kind remained on another social media platform, Mr Hooper's LinkedIn page until April 2021. 259 I am concerned that Mr Hooper's zealous enthusiasm for HBOT may see him tempted to return to posting material on social media, whether on the Website and Facebook Page, or on some other site controlled by him about the utility of treating the diseases and conditions in Schedules A and B of the SAFA. 260 I am also concerned that Mr Hooper lacks insight into the contravening conduct, in particular the seriousness of the conduct and why the conduct should not continue. 261 Oxymed and Mr Hooper received a warning letter about the posts on the Website and Facebook Page in May 2018 which drew attention to the relevant provisions of the TG Act. Rather than reflecting on whether their social media postings fell within the TG Act regulatory regime for advertising, or indeed making enquiries as to what that regime might require, Mr Hooper and Oxymed made no changes to their conduct of posting on the Website and Facebook Page. 262 At the hearing, Mr Hooper and Oxymed's senior counsel sought to downplay the contraventions, describing the postings as "educational" and seeking to portray Oxymed as akin to a sole trader tea shoppe promoting the health benefits of harmless peppermint tea. 263 Whilst not in the same category of posing an immediate serious risk of serious adverse effects to patients such as the supplements and peptides of Evolution and Peptides cases, the provision of HBOT is not without risk. The expert medical evidence was that there was a risk of harm to consumers who might not pursue the orthodox treatment for their condition, and the risk that vulnerable consumers also might suffer financial harm as a result of the cost of a course of HBOT. 264 There was no evidence in this case that HBOT presented a high risk of adverse effects or that it posed an unacceptable risk or direct danger to physical health from undergoing the therapy, as opposed to a more indirect, but still significant risk of harm from missing out on orthodox treatment for the condition. I agree with the Repondents' submission that in terms of direct harm to patients, the provision of HBOT is at the lower end of the scale and in a different class to the potential harm to people in the Peptides and Evolution cases. However, there is a potential for significant harm if patients with conditions such as cancer or HIV/AIDS defer or avoid orthodox evidence-based treatment in favour of pursuing HBOT. There is also the risk of substantial financial harm to patients depending on the length of the course of HBOT undertaken. 265 There is also a need for general deterrence to ensure that others are not tempted to engage in similar conduct by posting advertisements on social media, and to send a message that companies, and those in control of their conduct, will not be able to profit from their wrongdoing. 266 The Respondents' conduct involves a multitude of contraventions, even on Oxymed and Mr Hooper's analysis. As noted above, I consider it appropriate in this case to adopt a course of conduct analysis. I am not satisfied there is sufficient difference in conduct in posting material on the Website as opposed to the Facebook Page to regard them as separate courses of conduct. The evidence was that the postings on Facebook referred or "linked" to the Website. 267 Taking into account all of the matters to which I have referred above, I consider that the following penalties should be imposed upon Oxymed by reference to the three courses of conduct identified above: (1) Course of conduct 1 (representations of unregistered HBOT devices to which s 42DLB(9) applies): $1 million. (2) Course of conduct 2 (Restricted Representations to which s 42DLB(4) applies): $1.5 million. (3) Course of conduct 3 (the Prohibited Representations to which s 42DLB(2) applies): $1.5 million. 268 This amounts to $4 million. Having regard to the totality principle, I consider that a total penalty of $2 million is appropriate. 269 Taking into account all of the matters to which I have referred above, I consider that the following penalties should be imposed upon Mr Hooper by reference to the three courses of conduct identified above: (1) Course of conduct 1 (representations of unregistered HBOT devices to which s 42DLB(9) applies: $500,000. (2) Course of conduct 2 (Restricted Representations to which s 42DLB(4) applies): $750,000. (3) Course of conduct 3 (Prohibited Representations to which s 42DLB(2) applies): $750,000. 270 This amounts to $2 million. Having regard to the totality principle, I consider that a total penalty of $1 million is appropriate. I note that this penalty is beyond the range submitted as appropriate by the Secretary. Given the above, I consider there is a particularly strong need for deterrence in the case of Mr Hooper. I also consider that responsibility for the posts ultimately fell to Mr Hooper. 271 I also note that the amounts I have awarded for the three courses of conduct relative to one another do not necessarily reflect that sought by the Secretary. In my view, the contraventions caused by Prohibited Representations and Restricted Representations are of a more serious nature, given they have a greater potential to impact particularly vulnerable people than the HBOT Representations.

Declarations 272 As noted above, the Secretary seeks declaratory orders pursuant to s 21 of the Federal Court of Australia Act 1976 (Cth) (the FCA Act) to the effect that each of Oxymed and Mr Hooper contravened provisions of the TG Act, as well as injunctions and costs. 273 After the completion of the hearing the parties handed up an agreed form of declarations and injunctions. Given it is unnecessary to determine the precise number of individual contraventions I consider it appropriate to make the orders in the form provided by the parties, that is, without references to specific numbers of contraventions. 274 I accept that the making of declarations under s 21 of the FCA Act is appropriate in the public interest given the seriousness of the contraventions. I also accept the declarations are desirable and appropriate because they will record the Court's disapproval of the conduct, assist the Secretary in carrying out the duties conferred by the TG Act, assist in clarifying the law and make it clear to other would-be contraveners that such conduct is unlawful.

Injunctions 275 The Secretary seeks injunctions pursuant to s 42YN(1) of the TG Act restraining the Respondents from further contravening conduct. Again, the form of the injunctive orders was agreed by the parties and handed up at the conclusion of the hearing. The form of the agreed injunctive orders is appropriate.

Costs 276 The Secretary also seeks an order that Oxymed and Mr Hooper pay the Secretary's costs of and incidental to the proceedings. I consider that such an order is appropriate. I certify that the preceding two hundred and seventy-six (276) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Rofe.

ANNEXURE A - STATEMENT OF AGREED FACTS AND ADMISSIONS

STATEMENT OF AGREED FACTS AND ADMISSIONS FEDERAL COURT OF AUSTRALIA DISTRICT REGISTRY: VICTORIA DIVISION: GENERAL NO VID 558 OF 2020 SECRETARY OF THE DEPARTMENT OF HEALTH Applicant OXYMED AUSTRALIA PTY LTD (ACN 606 641 954) and another named in the schedule Respondents

A INTRODUCTION

1. This Statement of Agreed Facts and Submissions (SAFA) is made for the purposes of s 191 of the Evidence Act 1995 (Cth) jointly by the Applicant and the Respondents.
2. This SAFA relates to proceedings VID 558/2020 commenced by the Applicant (Secretary) against the Respondents by way of Originating Application and Affidavit filed on 21 August 2020 (Proceedings).
3. In the Proceedings, the Secretary seeks the relief set out in the Originating Application dated 21 August 2020, comprising: 3.1. declarations pursuant to s 21 of the Federal Court of Australia Act 1976 (Cth) (FCAA); 3.2. injunctions pursuant to s 42YN of the Therapeutic Goods Act 1989 (Cth) (TG Act); and 3.3. pecuniary penalties pursuant to s 42Y of the TG Act; and costs.
4. This SAFA identifies facts relevant to the contraventions of s 42DLB(1) of the TG Act that occurred between at least 20 February 2020 to 17 August 2020 (Relevant Period), which contraventions are admitted by the Respondents for the purposes of the Proceedings.

B THE PARTIES 5. The Secretary may apply to the Court for a declaration of contravention, injunction and a pecuniary penalty order pursuant to s 21 of the FCAA, s 42YN and s 42Y of the TG Act. 6. Throughout the Relevant Period, Oxymed Australia Pty Ltd (Oxymed): 6.1. was incorporated pursuant to the Corporations Act 2001 (Cth); 6.2. had its registered office in Victoria, Australia; and 6.3. carried on a business of administering hyperbaric oxygen therapy (HBOT) via hyperbaric oxygen therapy chambers (HBOT devices) to customers and promoting the HBOT services through advertisements on its website located at www.oxymed.com.au (the Website) and its Facebook page located at facebook.com/oxymedaustralia (Facebook Page). 7. Mr Malcolm Hooper (Mr Hooper) is the sole director and secretary of Oxymed. 8. In his capacity as sole director of Oxymed, Mr Hooper was responsible for managing the day-to-day operations of the company during the Relevant Period, including: 8.1. management and oversight of the administration of HBOT to clients; 8.2. management and approval of advertising and promotional materials published on the Website; and 8.3. management and approval of advertising and promotional materials published on the Facebook Page.

Oxymed Website and Facebook Page 9. Throughout the Relevant Period: 9.1. Oxymed operated the Website. 9.2. Mr Hooper was the registered contact for the Website. 9.3. Oxymed operated the Facebook Page. 9.4. Mr Hooper was responsible for all content that was published on the Website and Facebook Page and had oversight and authority over what was included or excluded from the Website and Facebook Page.

Hyperbaric Oxygen Therapy and Hyperbaric Oxygen Therapy Devices 10. HBOT is administered using HBOT devices. 11. HBOT is intended to deliver oxygen at 100% concentration and at a pressure above atmospheric pressure. 12. The HBOT devices are therapeutic goods within the meaning of s 3(1) of the TG Act because they are represented in a way to be, or are likely to be taken to be, for therapeutic use, namely for use in, or in connection with: 12.1. preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or 12.2. influencing, inhibiting or modifying a physiological process in persons; or 12.3. testing the susceptibility of persons to a disease or ailment.

Advertisements referring to the HBOT Devices 13. Throughout the Relevant Period, Oxymed advertised or caused the HBOT devices to be advertised on the Website and the Facebook Page within the meaning of s 3(1) of the TG Act, by promoting the use or supply of the HBOT devices as therapeutic goods for therapeutic use, including by: 13.1. making statements on the Website and Facebook Page to promote the use of the HBOT devices, by participating in HBOT, in the Oxymed clinic; 13.2. publishing pictorial representations of the HBOT devices on the Website and Facebook page when promoting the HBOT services offered at the Oxymed clinic; 13.3. offering HBOT services at the Oxymed clinic and a price list for such services; and 13.4. promoting the health benefits of the HBOT treatment in conjunction with the treatment or cure of a variety of conditions and illnesses, included those listed at Schedules A and B. 14. The HBOT devices are not, and were not at any relevant time, entered in the Australian Register of Therapeutic Goods maintained by the Secretary pursuant to s 9A(1) of the TG Act. 15. The HBOT devices are not, and were not at any relevant time, the subject of an exemption, approval or authority under the TG Act, nor an exemption, approval or authority under regulations made under the TG Act. 16. Consequently, the HBOT devices are, and were at all relevant times throughout the Relevant Period, prescribed by reg 7(i) of the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations) for the purposes of s 42DLB(9) of the TG Act. 17. Mr Hooper knew each of the matters set out in paragraphs 13 to 15 above, and caused or permitted the conduct of Oxymed referred to in paragraph 13 above by virtue of the matters set out in paragraphs 7, 8 and 9.4 above.

Advertisements containing restricted representations 18. During the Relevant Period, from at least 11 March 2020, Oxymed advertised the HBOT devices, or caused the HBOT devices to be advertised in circumstances where those advertisements contained references to the diseases or conditions or ailments listed in Schedule A. 19. The diseases or conditions or ailments, referred to in Schedule A were each serious forms of those diseases, conditions or ailments, within the meaning of s 28 of the Therapeutic Goods Advertising Code (No 2) 2018 (Cth) (TG Code), since it is medically accepted that they require diagnosis or treatment or supervision by a suitably qualified health professional, except where they have been medically diagnosed and medically accepted as being suitable for self-treatment and management. 20. The advertisements referred to in paragraph 18 above constituted representations, which were restricted representations within the meaning of s 42DD of the TG Act. 21. At no time did the Secretary give an approval under s 42DF(1) of the TG Act, or permission under s 42DK(1) of the TG Act, to make the restricted representations. 22. Mr Hooper knew of each of the matters alleged in paragraphs 18 and 21 above, and caused or permitted the conduct of Oxymed alleged in paragraph 18 above by virtue of the matters set out in paragraphs 7, 8 and 9.4 above.

Advertisements containing prohibited representations 23. During the Relevant Period, from at least 20 February 2020 to 19 June 2020, Oxymed advertised the HBOT Devices, or caused the HBOT Devices to be advertised in circumstances where those advertisements contained references to the diseases, or conditions or ailments listed in Schedule B. 24. The advertisements referred to in paragraph 23 above constituted representations, which were prohibited representations under s 30 of the TG Code for the purposes of reg 6B(1)(b) of the TG Regulations and, therefore, within the meaning of s 42DJ(1) of the TG Act. 25. At no time was a permission in force under s 42DK(1) of the TG Act in relation to the prohibited representations. 26. Mr Hooper knew of each of the matters alleged in paragraphs 23 and 25 above, and caused or permitted the conduct of Oxymed referred to in paragraph 23 above by virtue of the matters set out in paragraphs 7, 8 and 9.4 above.

D ADMITTED CONTRAVENTIONS 27. The Respondents admit that, during the Relevant Period: 28. By the conduct described in paragraphs 13 and 17 above, Oxymed and Mr Hooper each contravened s 42DLB(1) of the TG Act since s 42DLB(9) applies. . 29. By the conduct described in paragraphs 18 and 22 above, Oxymed and Mr Hooper each contravened s 42DLB(1) of the TG Act since s 42DLB(4) applies. 30. By the conduct described in paragraphs 23 and 26 above, Oxymed and Mr Hooper each contravened s 42DLB(1) of the TG Act since s 42DLB(2) applies. 31. Further to paragraphs 27 to 30 above, by reason of the matters alleged in paragraphs 7, 8, 9.4, 17, 22 and 26 above, Mr Hooper aided, abetted, counselled or procured Oxymed's contraventions of s 42DLB(1) and was therefore involved in those contraventions for the purposes of s 42YC of the TG Act. Date: 14 April 2021 ......................................... Matthew Garey AGS lawyer Lawyer for the Applicant Date: 14 April 2021 .............................................. Lawyer for the First Respondent Date: 14 April 2021 ............................................ Lawyer for the Second Respondent Schedule FEDERAL COURT OF AUSTRALIA DISTRICT REGISTRY: VICTORIA DIVISION: GENERAL NO VID 558 OF 2020 SECRETARY OF THE DEPARTMENT OF HEALTH Applicant OXYMED AUSTRALIA PTY LTD (ACN 606 641 954) First Respondent MALCOLM HOOPER Second Respondent Date: 14 April 2021 SCHEDULE A Condition Date of Representations Date of Screenshot Exhibit IJW-1 Reference Alzheimer's disease 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 14/05/2020-17/08/2020 2/04/2020 Volume 1, Tab 35, Page 456 14/05/2020 Volume 2, Tab 42, Page 638 20/05/2020 Volume 2, Tab 46, Page 716 4/06/2020 Volume 3, Tab 70, Page 1389 4/06/2020 Volume 3, Tab 70, Page 1392 17/06/2020 Volume 2, Tab 54, Page 849 17/06/2020 Volume 2, Tab 54, Page 865 17/06/2020 Volume 2, Tab 54, Page 883 18/06/2020 Volume 3, Tab 60, Page 1170 7/07/2020 Volume 3, Tab 65, Page 1251 24/07/2020 Volume 3, Tab 66, Page 1283 24/07/2020 Volume 3, Tab 66, Page 1299 24/07/2020 Volume 3, Tab 66, Page 1300 17/08/2020 Volume 3, Tab 72, Page 1424 17/08/2020 Volume 3, Tab 72, Page 1425 17/08/2020 Volume 3, Tab 72, Page 1439 Amyotrophic Lateral Sclerosis 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 497 Autism Spectrum Disorders 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 14/05/2020-18/06/2020; 24/07/2020 2/04/2020 Volume 1, Tab 35, Page 420 2/04/2020 Volume 1, Tab 35, Page 432 14/05/2020 Volume 2, Tab 42, Page 625 20/05/2020 Volume 2, Tab 46, Page 703 20/05/2020 Volume 2, Tab 46, Page 716 20/05/2020 Volume 2, Tab 46, Page 722 21/05/2020 Volume 3, Tab 69, Page 1356 28/05/2020 Volume 2, Tab 50, Page 784 28/05/2020 Volume 2, Tab 50, Page 786 4/06/2020 Volume 3, Tab 70, Page 1377 4/06/2020 Volume 3, Tab 70, Page 1388 17/06/2020 Volume 2, Tab 54, Page 849 17/06/2020 Volume 2, Tab 54, Page 865 17/06/2020 Volume 2, Tab 54, Page 875 17/06/2020 Volume 2, Tab 54, Page 876 17/06/2020 Volume 2, Tab 54, Page 883 17/06/2020 Volume 2, Tab 54, Page 884 17/06/2020 Volume 2, Tab 57, Page 1115 17/06/2020 Volume 2, Tab 58, Page 1139 18/06/2020 Volume 3, Tab 60, Page 1170 18/06/2020 Volume 3, Tab 61, Page 1176 24/07/2020 Volume 3, Tab 66, Page 1285 Autoimmune Illness 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 339 14/05/2020 31/03/2020 Volume 1, Tab 34, Page 344 31/03/2020 Volume 1, Tab 34, Page 368 2/04/2020 Volume 1, Tab 35, Page 438 14/05/2020 Volume 2, Tab 42, Page 642 Back Pain 13/03/2020-2/04/2020 13/03/2020 Volume 1, Tab 27, Page 308 31/03/2020 Volume 1, Tab 34, Page 364 2/04/2020 Volume 1, Tab 35, Page 399 2/04/2020 Volume 1, Tab 35, Page 402 Brain Injury 13/03/2020-3/04/2020; 13/03/2020 Volume 1, Tab 27, Page 310 27/04/2020-24/07/2020 31/03/2020 Volume 1, Tab 34, Page 344 31/03/2020 Volume 1, Tab 34, Page 345 2/04/2020 Volume 1, Tab 35, Page 398 3/04/2020 Volume 2, Tab 36, Page 594 27/04/2020 Volume 2, Tab 39, Page 608 14/05/2020 Volume 2, Tab 41, Page 614 14/05/2020 Volume 2, Tab 42, Page 616 14/05/2020 Volume 2, Tab 42, Page 618 14/05/2020 Volume 2, Tab 42, Page 631 14/05/2020 Volume 2, Tab 42, Page 632 14/05/2020 Volume 2, Tab 42, Page 638 14/05/2020 Volume 2, Tab 43, Page 679 20/05/2020 Volume 2, Tab 45, Page 691 20/05/2020 Volume 2, Tab 45, Page 693 20/05/2020 Volume 2, Tab 46, Page 701 20/05/2020 Volume 2, Tab 46, Page 709 20/05/2020 Volume 2, Tab 46, Page 723 21/05/2020 Volume 3, Tab 68, Page 1319 21/05/2020 Volume 3, Tab 69, Page 1356 21/05/2020 Volume 3, Tab 69, Page 1361 28/05/2020 Volume 2, Tab 50, Page 784 28/05/2020 Volume 2, Tab 50, Page 789 29/05/2020 Volume 2, Tab 52, Page 820 4/06/2020 Volume 3, Tab 70, Page 1377 4/06/2020 Volume 3, Tab 70, Page 1379 17/06/2020 Volume 2, Tab 54, Page 849 17/06/2020 Volume 2, Tab 54, Page 859 17/06/2020 Volume 2, Tab 54, Page 886 17/06/2020 Volume 2, Tab 58, Page 1136 17/06/2020 Volume 2, Tab 58, Page 1139 18/06/2020 Volume 3, Tab 61, Page 1174 18/06/2020 Volume 3, Tab 61, Page 1176 18/06/2020 Volume 3, Tab 61, Page 1178 24/07/2020 Volume 3, Tab 66, Page 1286 24/07/2020 Volume 3, Tab 66, Page 1289 Carbon monoxide (CO) poisoning 13/03/2020-3/04/2020; 13/03/2020 Volume 1, Tab 29, Page 316 21/05/2020-29/05/2020; 17/06/2020 31/03/2020 Volume 1, Tab 34, Page 344 31/03/2020 Volume 1, Tab 34, Page 345 2/04/2020 Volume 1, Tab 35, Page 418 3/04/2020 Volume 2, Tab 36, Page 597 21/05/2020 Volume 3, Tab 69, Page 1356 21/05/2020 Volume 3, Tab 69, Page 1360 29/05/2020 Volume 2, Tab 52, Page 804 17/06/2020 Volume 2, Tab 54, Page 875 17/06/2020 Volume 2, Tab 54, Page 876 17/06/2020 Volume 2, Tab 54, Page 877 17/06/2020 Volume 2, Tab 57, Page 1115 17/06/2020 Volume 2, Tab 57, Page 1119 17/06/2020 Volume 2, Tab 58, Page 1139 Cellulitis 31/03/2020 31/03/2020 Volume 1, Tab 34, Page 344 Cerebral Malaria 31/03/2020 31/03/2020 Volume 1, Tab 34, Page 344 Cerebral Palsy 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 14/05/2020-7/07/2020 31/03/2020 Volume 1, Tab 34, Page 345 2/04/2020 Volume 1, Tab 35, Page 449 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 398 2/04/2020 Volume 1, Tab 35, Page 420 2/04/2020 Volume 1, Tab 35, Page 422 2/04/2020 Volume 1, Tab 35, Page 486 2/04/2020 Volume 1, Tab 35, Page 538 14/05/2020 Volume 2, Tab 41, Page 616 14/05/2020 Volume 2, Tab 42, Page 625 14/05/2020 Volume 2, Tab 42, Page 638 14/05/2020 Volume 2, Tab 42, Page 643 14/05/2020 Volume 2, Tab 42, Page 645 14/05/2020 Volume 2, Tab 42, Page 647 14/05/2020 Volume 2, Tab 42, Page 648 14/05/2020 Volume 2, Tab 42, Page 660 20/05/2020 Volume 2, Tab 45, Page 693 20/05/2020 Volume 2, Tab 46, Page 703 20/05/2020 Volume 2, Tab 46, Page 716 20/05/2020 Volume 2, Tab 46, Page 721 20/05/2020 Volume 2, Tab 46, Page 724 20/05/2020 Volume 2, Tab 46, Page 725 20/05/2020 Volume 2, Tab 46, Page 726 20/05/2020 Volume 2, Tab 46, Page 738 21/05/2020 Volume 3, Tab 69, Page 1356 21/05/2020 Volume 3, Tab 69, Page 1362 28/05/2020 Volume 2, Tab 50, Page 784 28/05/2020 Volume 2, Tab 50, Page 789 29/05/2020 Volume 2, Tab 52, Page 822 29/05/2020 Volume 2, Tab 52, Page 805 4/06/2020 Volume 3, Tab 70, Page 1391 17/06/2020 Volume 2, Tab 54, Page 849 17/06/2020 Volume 2, Tab 54, Page 863 17/06/2020 Volume 2, Tab 54, Page 867 17/06/2020 Volume 2, Tab 54, Page 875 17/06/2020 Volume 2, Tab 54, Page 876 17/06/2020 Volume 2, Tab 54, Page 877 17/06/2020 Volume 2, Tab 54, Page 883 17/06/2020 Volume 2, Tab 56, Page 986 17/06/2020 Volume 2, Tab 56, Page 993 17/06/2020 Volume 2, Tab 57, Page 1115 17/06/2020 Volume 2, Tab 57, Page 1121 17/06/2020 Volume 2, Tab 58, Page 1139 17/06/2020 Volume 2, Tab 58, Page 1149 17/06/2020 Volume 2, Tab 54, Page 889 18/06/2020 Volume 3, Tab 60, Page 1170 24/07/2020 Volume 3, Tab 66, Page 1283 7/07/2020 Volume 3, Tab 65, Page 1252 Near Drowning (submersion injuries) 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 14/05/2020-17/06/2020 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 411 2/04/2020 Volume 1, Tab 35, Page 420 14/05/2020 Volume 2, Tab 42, Page 643 29/05/2020 Volume 2, Tab 52, Page 820 29/05/2020 Volume 2, Tab 52, Page 825 4/06/2020 Volume 3, Tab 70, Page 1381 17/06/2020 Volume 2, Tab 54, Page 859 17/06/2020 Volume 2, Tab 54, Page 860 Chronic Fatigue Illness 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 425 Chronic Infections 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 31/03/2020 Volume 1, Tab 34, Page 368 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 2, Tab 43, Page 676 Complex Pain Syndrome 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 396 Concussion Disability 13/03/2020-2/04/2020; 13/03/2020 Volume 1, Tab 27, Page 309 14/05/2020-29/06/2020 31/03/2020 Volume 1, Tab 34, Page 344 31/03/2020 Volume 1, Tab 34, Page 345 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 570 2/04/2020 Volume 1, Tab 35, Page 588 14/05/2020 Volume 2, Tab 42, Page 624 14/05/2020 Volume 2, Tab 44, Page 686 20/05/2020 Volume 2, Tab 46, Page 702 20/05/2020 Volume 2, Tab 46, Page 714 20/05/2020 Volume 2, Tab 48, Page 771 21/05/2020 Volume 3, Tab 68, Page 1323 21/05/2020 Volume 3, Tab 69, Page 1356 21/05/2020 Volume 3, Tab 69, Page 1361 28/05/2020 Volume 2, Tab 50, Page 788 29/05/2020 Volume 2, Tab 51, Page 793 4/06/2020 Volume 3, Tab 70, Page 1366 17/06/2020 Volume 2, Tab 54, Page 877 17/06/2020 Volume 2, Tab 54, Page 883 17/06/2020 Volume 2, Tab 54, Page 884 17/06/2020 Volume 2, Tab 54, Page 886 17/06/2020 Volume 2, Tab 57, Page 1115 17/06/2020 Volume 2, Tab 57, Page 1120 17/06/2020 Volume 2, Tab 58, Page 1125 17/06/2020 Volume 2, Tab 58, Page 1129 17/06/2020 Volume 2, Tab 58, Page 1139 18/06/2020 Volume 3, Tab 61, Page 1175 18/06/2020 Volume 3, Tab 61, Page 1178 29/06/2020 Volume 3, Tab 63, Page 1198 Coronavirus 11/03/2020-3/04/2020 11/03/2020 Volume 1, Tab 26, Page 299 11/03/2020 Volume 1, Tab 26, Page 300 13/03/2020 Volume 1, Tab 27, Page 305 17/03/2020 Volume 1, Tab 30, Page 319 17/03/2020 Volume 1, Tab 30, Page 320 23/03/2020 Volume 1, Tab 32, Page 328 23/03/2020 Volume 1, Tab 32, Page 329 27/03/2020 Volume 1, Tab 33, Page 331 27/03/2020 Volume 1, Tab 33, Page 332 31/03/2020 Volume 1, Tab 34, Page 344 31/03/2020 Volume 1, Tab 34, Page 388 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 588 3/04/2020 Volume 2, Tab 36, Page 592 3/04/2020 Volume 2, Tab 36, Page 593 Crohn's Disease 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 20/05/2020, 17/08/2020 2/04/2020 Volume 1, Tab 35, Page 477 2/04/2020 Volume 1, Tab 35, Page 396 20/05/2020 Volume 2, Tab 46, Page 702 17/08/2020 Volume 3, Tab 72, Page 1439 Crush Injury 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 14/05/2020-21/05/2020; 17/06/2020 31/03/2020 Volume 1, Tab 34, Page 356 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 428 2/04/2020 Volume 1, Tab 35, Page 429 2/04/2020 Volume 1, Tab 35, Page 435 14/05/2020 Volume 2, Tab 43, Page 681 20/05/2020 Volume 2, Tab 47, Page 765 21/05/2020 Volume 3, Tab 69, Page 1356 21/05/2020 Volume 3, Tab 69, Page 1364 17/06/2020 Volume 2, Tab 57, Page 1115 17/06/2020 Volume 2, Tab 58, Page 1132 17/06/2020 Volume 2, Tab 58, Page 1137 17/06/2020 Volume 2, Tab 58, Page 1139 Cytokine Storm Syndrome 11/03/2020-2/04/2020; 11/03/2020 Volume 1, Tab 26, Page 300 17/06/2020-24/07/2020 11/03/2020 Volume 1, Tab 26, Page 301 27/03/2020 Volume 1, Tab 33, Page 332 27/03/2020 Volume 1, Tab 33, Page 333 31/03/2020 Volume 1, Tab 34, Page 344 31/03/2020 Volume 1, Tab 34, Page 368 31/03/2020 Volume 1, Tab 34, Page 388 31/03/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 414 2/04/2020 Volume 1, Tab 35, Page 588 17/06/2020 Volume 2, Tab 54, Page 851 17/06/2020 Volume 2, Tab 58, Page 1150 18/06/2020 Volume 3, Tab 60, Page 1182 18/06/2020 Volume 3, Tab 65, Page 1253 24/07/2020 Volume 3, Tab 66, Page 1298 Dementia | 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 Cognitive Decline 21/05/2020-17/08/2020 31/03/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 456 21/05/2020 Volume 3, Tab 69, Page 1359 4/06/2020 Volume 3, Tab 70, Page 1389 4/06/2020 Volume 3, Tab 70, Page 1392 17/06/2020 Volume 2, Tab 54, Page 849 17/06/2020 Volume 2, Tab 54, Page 865 17/06/2020 Volume 2, Tab 54, Page 876 17/06/2020 Volume 2, Tab 54, Page 883 17/06/2020 Volume 2, Tab 58, Page 1125 18/06/2020 Volume 3, Tab 60, Page 1170 7/07/2020 Volume 3, Tab 65, Page 1251 24/07/2020 Volume 3, Tab 66, Page 1283 17/08/2020 Volume 3, Tab 72, Page 1424 17/08/2020 Volume 3, Tab 72, Page 1425 Disc Prolapse 13/03/2020-2/04/2020; 13/03/2020 Volume 1, Tab 27, Page 308 4/06/2020-24/07/2020, 17/08/2020 31/03/2020 Volume 1, Tab 34, Page 339 31/03/2020 Volume 1, Tab 34, Page 344 31/03/2020 Volume 1, Tab 34, Page 364 2/04/2020 Volume 1, Tab 35, Page 399 2/04/2020 Volume 1, Tab 35, Page 438 17/06/2020 Volume 2, Tab 54, Page 865 4/06/2020 Volume 3, Tab 70, Page 1392 18/06/2020 Volume 3, Tab 65, Page 1251 24/07/2020 Volume 3, Tab 66, Page 1282 4/06/2020 Volume 3, Tab 70, Page 1388 17/08/2020 Volume 3, Tab 72, Page 1424 Failed Back Surgery 13/03/2020-2/04/2020; 13/03/2020 Volume 1, Tab 27, Page 308 17/06/2020-17/08/2020 31/03/2020 Volume 1, Tab 34, Page 339 31/03/2020 Volume 1, Tab 34, Page 344 31/03/2020 Volume 1, Tab 34, Page 364 31/03/2020 Volume 1, Tab 34, Page 373 2/04/2020 Volume 1, Tab 35, Page 399 2/04/2020 Volume 1, Tab 35, Page 438 17/06/2020 Volume 2, Tab 54, Page 865 17/06/2020 Volume 2, Tab 58, Page 1127 Condition Date of Representations Date of Screenshot Exhibit IJW-1 Reference 18/06/2020 Volume 3, Tab 65, Page 1251 24/07/2020 Volume 3, Tab 66, Page 1282 4/06/2020 Volume 3, Tab 70, Page 1388 4/06/2020 Volume 3, Tab 70, Page 1390 17/08/2020 Volume 3, Tab 72, Page 1424 Fibromyalgia 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 21/05/2020-18/06/2020 31/03/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 425 2/04/2020 Volume 1, Tab 35, Page 470 21/05/2020 Volume 3, Tab 69, Page 1359 17/06/2020 Volume 2, Tab 54, Page 876 17/06/2020 Volume 2, Tab 54, Page 886 17/06/2020 Volume 2, Tab 58, Page 1125 17/06/2020 Volume 2, Tab 58, Page 1127 18/06/2020 Volume 3, Tab 61, Page 1178 Fracture Repair 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 31/03/2020 Volume 1, Tab 34, Page 345 2/04/2020 Volume 1, Tab 35, Page 398 2/04/2020 Volume 1, Tab 35, Page 446 Gadolinium Poisoning 31/03/2020 31/03/2020 Volume 1, Tab 34, Page 344 Hearing Loss 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 473 Hospital Infections (MRSA, VRE) 31/03/2020; 14/05/2020- 31/03/2020 Volume 1, Tab 34, Page 344 17/06/2020 14/05/2020 Volume 2, Tab 41, Page 616 20/05/2020 Volume 2, Tab 45, Page 693 4/06/2020 Volume 3, Tab 70, Page 1369 17/06/2020 Volume 2, Tab 54, Page 840 Irritable Bowel Syndrome 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 432 Infertility 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 396 Kidney Disease 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 396 Liver Disease 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 396 Lyme Disease 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 21/05/2020-29/05/2020; 17/06/2020 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 414 2/04/2020 Volume 1, Tab 35, Page 480 21/05/2020 Volume 3, Tab 69, Page 1356 21/05/2020 Volume 3, Tab 69, Page 1359 29/05/2020 Volume 2, Tab 52, Page 804 17/06/2020 Volume 2, Tab 54, Page 875 17/06/2020 Volume 2, Tab 54, Page 876 17/06/2020 Volume 2, Tab 57, Page 1115 17/06/2020 Volume 2, Tab 58, Page 1129 17/06/2020 Volume 2, Tab 58, Page 1139 Macular Degeneration 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 484 Multiple Sclerosis 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 14/05/2020-17/08/2020 31/03/2020 Volume 1, Tab 34, Page 359 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 491 14/05/2020 Volume 2, Tab 42, Page 639 14/05/2020 Volume 2, Tab 42, Page 646 20/05/2020 Volume 2, Tab 46, Page 717 20/05/2020 Volume 2, Tab 46, Page 724 21/05/2020 Volume 3, Tab 69, Page 1356 21/05/2020 Volume 3, Tab 69, Page 1359 21/05/2020 Volume 3, Tab 69, Page 1363 29/05/2020 Volume 2, Tab 52, Page 805 17/06/2020 Volume 2, Tab 54, Page 849 17/06/2020 Volume 2, Tab 54, Page 875 17/06/2020 Volume 2, Tab 54, Page 876 17/06/2020 Volume 2, Tab 54, Page 877 17/06/2020 Volume 2, Tab 57, Page 1115 17/06/2020 Volume 2, Tab 57, Page 1122 17/06/2020 Volume 2, Tab 58, Page 1139 18/06/2020 Volume 3, Tab 66, Page 1290 24/07/2020 Volume 3, Tab 66, Page 1300 17/08/2020 Volume 3, Tab 72, Page 1439 Muscular Dystrophy 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 396 Motor Neuron Disease 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 31/03/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 497 2/04/2020 Volume 1, Tab 35, Page 502 Osteoporosis 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 24/07/2020; 17/08/2020. 2/04/2020 Volume 1, Tab 35, Page 408 2/04/2020 Volume 1, Tab 35, Page 507 24/07/2020 Volume 3, Tab 66, Page 1300 17/08/2020 Volume 3, Tab 72, Page 1439 Pancreatitis 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 516 Paraplegia, Quadriplegia 31/03/2020; 14/05/2020- 31/03/2020 Volume 1, Tab 34, Page 344 17/06/2020 14/05/2020 Volume 2, Tab 42, Page 644 21/05/2020 Volume 3, Tab 69, Page 1359 4/06/2020 Volume 3, Tab 70, Page 1390 17/06/2020 Volume 2, Tab 54, Page 863 17/06/2020 Volume 2, Tab 54, Page 866 17/06/2020 Volume 2, Tab 54, Page 876 17/06/2020 Volume 2, Tab 58, Page 1127 Psoriasis 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 14/05/2020-17/08/2020 31/03/2020 Volume 1, Tab 34, Page 346 2/04/2020 Volume 1, Tab 35, Page 398 2/04/2020 Volume 1, Tab 35, Page 529 14/05/2020 Volume 2, Tab 42, Page 620 20/05/2020 Volume 2, Tab 45, Page 698 21/05/2020 Volume 3, Tab 69, Page 1356 21/05/2020 Volume 3, Tab 69, Page 1363 17/06/2020 Volume 2, Tab 54, Page 875 17/06/2020 Volume 2, Tab 54, Page 877 17/06/2020 Volume 2, Tab 57, Page 1115 17/06/2020 Volume 2, Tab 57, Page 1122 17/06/2020 Volume 2, Tab 58, Page 1139 24/07/2020 Volume 3, Tab 66, Page 1300 17/08/2020 Volume 3, Tab 72, Page 1439 Radiation Necrosis 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 534 Reflex Sympathetic Dystrophy 31/03/2020 31/03/2020 Volume 1, Tab 34, Page 344 Spinal Cord Injury 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 345 27/04/2020-17/06/2020 31/03/2020 Volume 1, Tab 34, Page 356 2/04/2020 Volume 1, Tab 35, Page 411 31/03/2020 Volume 1, Tab 35, Page 464 2/04/2020 Volume 1, Tab 35, Page 517 2/04/2020 Volume 1, Tab 35, Page 526 2/04/2020 Volume 1, Tab 35, Page 559 27/04/2020 Volume 2, Tab 39, Page 608 14/05/2020 Volume 2, Tab 41, Page 614 14/05/2020 Volume 2, Tab 41, Page 616 14/05/2020 Volume 2, Tab 42, Page 623 14/05/2020 Volume 2, Tab 43, Page 679 20/05/2020 Volume 2, Tab 45, Page 693 20/05/2020 Volume 2, Tab 45, Page 701 20/05/2020 Volume 2, Tab 47, Page 762 27/05/2020 Volume 2, Tab 50, Page 782 28/05/2020 Volume 2, Tab 50, Page 784 28/05/2020 Volume 2, Tab 50, Page 789 4/06/2020 Volume 3, Tab 70, Page 1379 4/06/2020 Volume 3, Tab 70, Page 1381 17/06/2020 Volume 2, Tab 54, Page 875 17/06/2020 Volume 2, Tab 54, Page 876 17/06/2020 Volume 2, Tab 54, Page 877 17/06/2020 Volume 2, Tab 58, Page 1136 17/06/2020 Volume 2, Tab 54, Page 863 17/06/2020 Volume 2, Tab 54, Page 866 17/06/2020 Volume 2, Tab 58, Page 1127 17/06/2020 Volume 2, Tab 54, Page 859 17/06/2020 Volume 2, Tab 56, Page 990 21/05/2020 Volume 3, Tab 68, Page 1319 4/06/2020 Volume 3, Tab 70, Page 1377 4/06/2020 Volume 3, Tab 70, Page 1390 17/08/2020 Volume 3, Tab 72, Page 1430 Spinal Instability 31/03/2020 31/03/2020 Volume 1, Tab 34, Page 344 Sensorineural Hearing Loss 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 545 Stroke 13/03/2020-3/04/2020; 13/03/2020 Volume 1, Tab 27, Page 307 14/05/2020-18/06/2020 13/03/2020 Volume 1, Tab 29, Page 316 31/03/2020 Volume 1, Tab 34, Page 344 31/03/2020 Volume 1, Tab 34, Page 349 31/03/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 411 2/04/2020 Volume 1, Tab 35, Page 449 2/04/2020 Volume 1, Tab 35, Page 461 2/04/2020 Volume 1, Tab 35, Page 462 2/04/2020 Volume 1, Tab 35, Page 465 2/04/2020 Volume 1, Tab 35, Page 550 3/04/2020 Volume 2, Tab 36, Page 596 14/05/2020 Volume 2, Tab 42, Page 618 14/05/2020 Volume 2, Tab 42, Page 619 14/05/2020 Volume 2, Tab 42, Page 620 14/05/2020 Volume 2, Tab 42, Page 623 14/05/2020 Volume 2, Tab 42, Page 630 14/05/2020 Volume 2, Tab 42, Page 638 14/05/2020 Volume 2, Tab 42, Page 640 14/05/2020 Volume 2, Tab 42, Page 646 14/05/2020 Volume 2, Tab 42, Page 648 14/05/2020 Volume 2, Tab 42, Page 650 20/05/2020 Volume 2, Tab 45, Page 693 20/05/2020 Volume 2, Tab 46, Page 698 20/05/2020 Volume 2, Tab 46, Page 696 20/05/2020 Volume 2, Tab 46, Page 701 20/05/2020 Volume 2, Tab 46, Page 708 20/05/2020 Volume 2, Tab 46, Page 716 20/05/2020 Volume 2, Tab 46, Page 724 20/05/2020 Volume 2, Tab 46, Page 726 20/05/2020 Volume 2, Tab 46, Page 728 21/05/2020 Volume 3, Tab 69, Page 1359 28/05/2020 Volume 2, Tab 50, Page 784 28/05/2020 Volume 2, Tab 50, Page 789 4/06/2020 Volume 3, Tab 70, Page 1381 29/05/2020 Volume 2, Tab 52, Page 805 17/06/2020 Volume 2, Tab 54, Page 849 17/06/2020 Volume 2, Tab 54, Page 859 17/06/2020 Volume 2, Tab 54, Page 867 17/06/2020 Volume 2, Tab 54, Page 876 17/06/2020 Volume 2, Tab 54, Page 883 17/06/2020 Volume 2, Tab 54, Page 886 17/06/2020 Volume 2, Tab 58, Page 1125 17/06/2020 Volume 2, Tab 58, Page 1126 17/06/2020 Volume 2, Tab 58, Page 1129 17/06/2020 Volume 2, Tab 58, Page 1149 18/06/2020 Volume 3, Tab 60, Page 1170 18/06/2020 Volume 3, Tab 61, Page 1178 18/06/2020 Volume 3, Tab 66, Page 1290 Tarlov Cyst 31/03/2020-2/04/2020 31/03/2020 Volume 1, Tab 34, Page 344 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 563 Traumatic Brain Injury 13/03/2020-3/04/2020; 31/03/2020 Volume 1, Tab 34, Page 354 14/05/2020-18/06/2020 31/03/2020 Volume 1, Tab 34, Page 357 31/03/2020 Volume 1, Tab 35, Page 396 31/03/2020 Volume 1, Tab 35, Page 460 2/04/2020 Volume 1, Tab 35, Page 556 2/04/2020 Volume 1, Tab 35, Page 570 2/04/2020 Volume 1, Tab 35, Page 588 3/04/2020 Volume 2, Tab 36, Page 595 14/05/2020 Volume 2, Tab 42, Page 623 14/05/2020 Volume 2, Tab 42, Page 624 14/05/2020 Volume 2, Tab 42, Page 630 14/05/2020 Volume 2, Tab 42, Page 632 14/05/2020 Volume 2, Tab 42, Page 635 14/05/2020 Volume 2, Tab 42, Page 637 14/05/2020 Volume 2, Tab 42, Page 638 14/05/2020 Volume 2, Tab 42, Page 639 20/05/2020 Volume 2, Tab 46, Page 708 20/05/2020 Volume 2, Tab 46, Page 715 21/05/2020 Volume 3, Tab 69, Page 1356 28/05/2020 Volume 2, Tab 50, Page 784 28/05/2020 Volume 2, Tab 50, Page 788 29/05/2020 Volume 2, Tab 52, Page 824 17/06/2020 Volume 2, Tab 54, Page 849 17/06/2020 Volume 2, Tab 54, Page 884 17/06/2020 Volume 2, Tab 54, Page 875 17/06/2020 Volume 2, Tab 54, Page 876 17/06/2020 Volume 2, Tab 54, Page 883 17/06/2020 Volume 2, Tab 54, Page 849 17/06/2020 Volume 2, Tab 58, Page 1125 17/06/2020 Volume 2, Tab 58, Page 1148 18/06/2020 Volume 3, Tab 60, Page 1170 Ulcerative Colitis 31/03/2020-2/04/2020; 31/03/2020 Volume 1, Tab 34, Page 344 20/05/2020-21/05/2020; 17/06/2020 31/03/2020 Volume 1, Tab 34, Page 345 2/04/2020 Volume 1, Tab 35, Page 396 2/04/2020 Volume 1, Tab 35, Page 398 2/04/2020 Volume 1, Tab 35, Page 432 2/04/2020 Volume 1, Tab 35, Page 477 20/05/2020 Volume 2, Tab 46, Page 702 21/05/2020 Volume 3, Tab 69, Page 1356 21/05/2020 Volume 3, Tab 69, Page 1359 21/05/2020 Volume 3, Tab 69, Page 1362 17/06/2020 Volume 2, Tab 54, Page 875 17/06/2020 Volume 2, Tab 54, Page 876 17/06/2020 Volume 2, Tab 54, Page 877 17/06/2020 Volume 2, Tab 57, Page 1115 17/06/2020 Volume 2, Tab 57, Page 1121 17/06/2020 Volume 2, Tab 58, Page 1139

ANNEXURE B - SUPPLEMENTARY STATEMENT OF AGREED FACTS SUPPLEMENTARY STATEMENT OF AGREED FACTS FEDERAL COURT OF AUSTRALIA DISTRICT REGISTRY: VICTORIA DIVISION: GENERAL NO VID 558 OF 2020 SECRETARY OF THE DEPARTMENT OF HEALTH Applicant OXYMED AUSTRALIA PTY LTD (ACN 606 641 954) and another named in the schedule Respondents

INTRODUCTION

1. This Supplementary Statement of Agreed Facts (SSAF) is made for the purposes of s 191 of the Evidence Act 1995 (Cth) jointly by the Applicant and the Respondents.
2. Defined terms in this SSAF have the same meaning as the defined terms in the Statement of Agreed Facts and Admissions filed on 14 April 2021.

SIZE AND FINANCIAL POSITION OF THE FIRST RESPONDENT (OXYMED) 3. During the Relevant Period, Oxymed: 3.1. employed Mr Hooper as director; and 3.2. engaged two sub-contractors for the purposes of the role of technical assistance and accounts manager. 4. In the 2018-2019 financial year, Oxymed's turnover was $685,023 and gross profit was $512,328. The net profit for the year was $6,345. 5. In the 2019-2020 financial year, Oxymed's turnover was $674,367 and gross profit was $473,989. The net loss for the year was $85,905. 6. During the Relevant Period: 6.1. Oxymed's turnover was $352,206 prior to discounts; and 6.2. Oxymed's turnover from HBOT services was $323,204 prior to discounts.

OXYMED'S PRACTICE 7. During the Relevant Period, the price of HBOT provided by Oxymed was $129.59 per 60 minutes of treatment. 8. During the Relevant Period, Oxymed treated 80 clients. 9. During the Relevant Period, 25 of those 80 clients treated by Oxymed suffered from the following conditions listed in Schedules A and B of the SAFA: 9.1. Posttraumatic Stress Disorder: 1 client 9.2. Chronic Fatigue: 2 clients 9.3. Stroke: 1 client 9.4. Cancer: 15 clients 9.5. Multiple Sclerosis: 2 clients 9.6. Spinal Cord Injury: 2 clients 9.7. Radiation Necrosis: 1 client 9.8. Quadriplegia: 1 client.

SALARY AND EMOLUMENTS OF SECOND RESPONDENT (MR HOOPER) 10. During the Relevant Period: 10.1. Oxymed paid Mr Hooper $12,500 in salary and director's fees; and 10.2. $50,000 was withdrawn from the director loan account, which was in Mr Hooper's and Ms Catherine Hooper's name, by Mr Hooper. Date: 20 July 2021 Date: 20 July 2021 Date: 20 July 2021 Matthew Garey Lawyer for the First Respondent Lawyer for the Second Respondent AGS lawyer Lawyer for the Applicant