Australian Vaccination-Risks Network Incorporated v Secretary, Department of Health

Federal Court of Australia|2022-03-31|Before: Perry J

INTRODUCTION 1 By an amended originating application filed on 8 March 2022 (the Application), the applicant, Australian Vaccination-Risks Network Incorporated (AVN), seeks relief with respect to a number of decisions made or omitted to be made by the respondent, the Secretary of the Department of Health, Dr Brendan Murphy (the Secretary), under the Therapeutic Goods Act 1989 (Cth) (TG Act). 2 While only one proceeding was instituted, that proceeding involves two separate cases. Broadly speaking, these may be described as follows. 3 First, AVN seeks orders requiring the Secretary to consider whether to exercise his powers or discharge his alleged duty to cancel or suspend the provisional registration of three COVID-19 vaccines under the TG Act, commonly known as the Pfizer, AstraZeneca, and Moderna COVID-19 vaccines (collectively, the Three Vaccines). Further or alternatively, declaratory relief is sought to similar effect. This is described in the Application as the Mandamus Case. 4 Secondly, AVN seeks orders quashing or setting aside the decision by the Secretary to grant provisional approval with respect to the Comirnaty (tozinameran) COVID-19 vaccine sponsored by Pfizer Australia Pty Ltd (Pfizer), for use among children aged 5 to 11 years from 10 January 2022 (the Children Decision), and any determination made by the Secretary pursuant to s 22D of the TG Act to the effect that an indication of "the proposed Pfizer vaccine" was the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition for children between 5 to 11 years of age (s 22D Determination). These aspects of the proceeding are described in the Application as the Judicial Review Case. 5 AVN alleged that it has standing under s 39B of the Judiciary Act 1903 (Cth) (Judiciary Act) and/or that it is a "person aggrieved" for the purposes of the Administrative Decisions (Judicial Review) Act 1977 (Cth) (ADJR Act), and therefore that the Court has jurisdiction to entertain the application for relief. 6 However, by a notice of objection to competency filed on 18 February 2022 (the notice of objection to competency) the Secretary contended that AVN lacked standing to seek the relief sought in the Mandamus Case and Judicial Review Case and that there was therefore no "matter" in the constitutional sense. The Secretary also contended that AVN was not a "person aggrieved" for the purposes of ss 5 and 7 of the ADJR Act, and that the proceedings were therefore not competent insofar as those provisions were relied upon to engage the jurisdiction of the Court. 7 Subsequently, by way of an interlocutory application filed on 24 February 2022 (the joinder application), AVN sought leave to join Mr Mark Neugebauer as the second applicant (the joinder applicant). AVN contended that, whatever the position with respect to its standing to institute the proceeding, Mr Neugebauer separately had standing to pursue the Mandamus Case and Judicial Review Case and/or was a "person aggrieved" in the statutory sense under the ADJR Act. (I note that it is convenient when referring both to AVN and the joinder applicant to describe them jointly in these reasons as "the applicants".) In this way, AVN and Mr Neugebauer sought to "cure" the lack of jurisdiction in the event that the Court upheld the notice of objection to competency. 8 While the question whether an applicant has standing logically precedes any consideration of the merits of a particular matter, the Court has a discretion as to whether or not the question of standing to bring an action should be determined before proceeding to determine the merits of the case: Robinson v Western Australian Museum (1977) 138 CLR 283 (Robinson) at 302 (Gibbs J); Australian Conservation Foundation Inc v Commonwealth (1980) 146 CLR 493 (ACF) at 532-533 (Gibbs J); Onus v Alcoa of Australia Ltd (1981) 149 CLR 27 (Onus) at 38 (Gibbs CJ). In all of the circumstances, I agreed with the Secretary's submissions that it was appropriate to hear and determine the question of standing before trial, and I considered that this was the best use of the Court's and parties' time and resources bearing in mind ss 37M and 37N of the Federal Court of Australia Act 1976 (Cth) (FCA Act). In reaching this view, I took into account among other things that the parties had already joined issue by the filing of concise statements of facts, issues and contentions with respect to both the Mandamus Case and the Judicial Review Case. Furthermore, in my view it was necessary to determine the joinder application, which raised similar jurisdictional issues, in advance of any trial and it was therefore convenient to hear and determine that application and the notice of objection to competency at the same time. Moreover, the Mandamus Case in particular raised potentially complex issues of fact in respect of which a substantial body of evidence, including expert opinion evidence, had already been filed by AVN, and responding to that evidence may well have involved considerable expense on the part of the Secretary despite the fact that there was a serious question as to whether the Court had jurisdiction in the first place. 9 After hearing the parties' submissions on the jurisdictional issues in respect of the Mandamus Case and the Judicial Review Case on 23 March 2022, I made orders on 31 March 2022 dismissing the joinder application and upholding the Secretary's notice of objection to competency. Accordingly, I dismissed the Application on the grounds noted in my orders on 31 March 2022, namely: 9. In so far as the Application seeks an order quashing or setting aside the decision of the Therapeutic Goods Administration (TGA) made on or about 3 December 2021 to grant provisional approval with respect to Comirnaty (tozinameran) (Pfizer), being the COVID-19 vaccine sponsored by Pfizer Australia Pty Ltd, for use among children aged 5 to 11 years from 10 January 2022 (the TGA Decision), or any determination made by the respondent pursuant to s 22D of the Therapeutic Goods Act 1989 (Cth) (TG Act) to the effect pleaded in ground 3A of the prayer for relief in the Application: a) the Application is not competent in so far as it is made under the Administrative Decisions (Judicial Review) Act 1977 (Cth) (ADJR Act) as the applicant is not a "person aggrieved" for the purposes of s 5 of the ADJR Act; b) in so far as the Application is made under s 39B of the Judiciary Act 1903 (Cth) (Judiciary Act), the applicant does not have standing to challenge the TGA Decision; and c) by reason of the ground identified in paragraph 9(b) above, the Application does not involve a real justiciable controversy as to some immediate right, duty or liability between the applicant and the respondent such as to constitute a "matter" in respect of which the Court has jurisdiction vested in it in accordance with Chapter III of the Constitution. 10. In so far as the Application seeks mandamus or declaratory relief for the exercise of powers or discharge of statutory duty by the respondent under ss 9A(1), 29D, 30(1)(a) and 30(2)(a) of the TG Act with respect to the three vaccines as defined in the Application: a) the Application is not competent in so far as it is made under the ADJR Act as the applicant is not a "person aggrieved" for the purposes of s 7 of the ADJR Act; b) in so far as the Application is made under s 39B of the Judiciary Act, the applicant does not have standing; and c) by reason of the ground identified in paragraph 10(b) above, the Application does not involve a real justiciable controversy as to some immediate right, duty or liability between the applicant and the respondent such as to constitute a "matter" in respect of which the Court has jurisdiction vested in it in accordance with Chapter III of the Constitution. 10 As discussed with the parties, I made the orders on 31 March 2022 (the 31 March Orders), with reasons to be published later in order to give the parties certainty at the earliest possible time as to whether the trial of the Judicial Review Case would proceed on 20 April 2022 when it was listed subject to my decision on the jurisdictional issues. These are my reasons for refusing the joinder application, and for dismissing the Application on the grounds summarised in the notation to the 31 March Orders.

EVIDENCE 11 In support of its case as to standing and the joinder application, AVN relied upon the court book in the Judicial Review Case (Exhibit A-1) (JRCB), the court book in the Mandamus Case (Exhibit A-2) (MCB), and correspondence contained in the revised Supplementary Court Book (SuppCB) as tendered at the hearing (and marked Exhibit A-3). The material contained in the JRCB and MCB included the following affidavit evidence: (1) the affidavits of Meryl Dorey affirmed on 29 January 2022 and 28 February 2022 (the January and February Dorey affidavits respectively, and together, the Dorey affidavits); (2) the affidavits of Mark Neugebauer affirmed on 22 February, 1 March and 7 March 2022 (the First, Second and Third Neugebauer affidavits respectively, and together, the Neugebauer affidavits). 12 It is convenient to consider first, the tender of the correspondence behind tabs 2, 3 and 4 of the SuppCB containing correspondence by the applicants (noting that the document behind tab 1 was not tendered). The Secretary objected to the admission of this correspondence on the ground that it was not relevant because it post-dated the Children Decision, but suggested that the documents could be admitted provisionally under s 57 and subject to s 136 of the Evidence Act 1995 (Cth) (Evidence Act) (T23/3/22 at 4.35-5.8). Counsel for the applicants, Mr Robinson SC, however explained that the correspondence was sought to be admitted "only as to the nature and extent of the interest of the AVN, or the [joinder] applicant. We don't put it any higher or stronger than that…" (T23/3/22 at 5.38-5.40). In other words, as Mr Robinson SC accepted, the documents were sought to be relied upon at this stage to demonstrate that each of AVN and the joinder applicant has a sufficient or special interest in the subject matter of the proceedings, as opposed to establishing AVN's substantive case that, among other things, it had raised serious concerns with the Secretary as evidenced by the scientific evidence referred to in the correspondence (T23/3/22 at 6.10-12 and 7.11-7.34). 13 At the hearing, the evidence contained in tabs 2, 3 and 4 of the SuppCB was admitted provisionally subject to relevance under s 57 of the Evidence Act (the s 57 proviso) and subject to a limitation on the use to which it could be put under s 136 of the Evidence Act (the s 136 Limitation) (which I explain below). In my view, Mr Robinson SC established that the documents were relevant for the reasons he explained (subject to one caveat) and they should be admitted without the s 57 proviso but subject to the s 136 Limitation. The caveat is that Mr Robinson SC also described the correspondence as "essentially letters of demand which my client has written in the - both in the Children [D]ecision matter but also in the mandamus case" (T23/3/22 at 4.20-21). The phrase "letter of demand" is generally used to refer to a formal document issued to another in order to resolve a dispute typically for payment of a debt and is generally the last step taken before legal proceedings (such as to recover the debt) are instituted. That is not an appropriate characterisation of the correspondence here. However, I accept that the correspondence was intended to give notice of AVN's intention to institute proceeding in the event that its "demands" were not met. 14 Secondly, the Secretary objected to the bulk of the applicants' affidavit evidence, with an extensive list of objections and the applicants' responses to those objections being filed on 22 March 2022. As a result, I called the matter on for an urgent case management hearing on 22 March 2022 at which I expressed my concern, among other things, as to the time that hearing and ruling on the objections was likely to take when the jurisdictional issues were set down only for a one day hearing and as to the need, as a matter of fairness, for the applicants to be able to present their case. Following that case management hearing, the Secretary presented a document on the morning of the hearing setting out its revised position vis a vis the applicants' evidence which significantly reduced the scope of the objections, as the applicants acknowledged (T 23/3/22 at 9.44-45). 15 The bulk of the Secretary's objections were made on the basis that the evidence was conclusory in nature, inadmissible opinion evidence, and/or hearsay in nature if the evidence was being adduced to prove the truth of the representations asserted. The Secretary's revised position was that the bulk of the evidence could be admitted if made subject to the s 136 Limitation, that is, a limitation on the use to which it could be put under s 136 of the Evidence Act. In its revised list of objections, the Secretary defined the scope of the s 136 Limitation sought as follows: • Evidence of deponent's understanding or belief only. • Where evidence is based on previous representation(s) made by others, it is not admitted to prove the truth of those representations. • Where evidence contains opinion, it is not admitted to prove the existence of facts about which the opinion was expressed. 16 In this regard, I note that s 136 of the Evidence Act provides that: The court may limit the use to be made of evidence if there is a danger that a particular use of the evidence might: a) be unfairly prejudicial to a party; or b) be misleading or confusing. 17 Given, however, the lack of any real opportunity prior to the hearing for the applicants to consider the Secretary's revised list of objections, the applicants were offered the opportunity to file written submissions after the hearing responding to the remaining objections. As such, the Dorey affidavits and Neugebauer affidavits were taken as read subject to the Court ruling on the outstanding objections to that evidence once the applicants had had the opportunity to consider those further. Ultimately, however, the applicants took the view that they did not wish to say anything beyond that set out in their earlier submission in response to the Secretary's original list of objections (T23/3/22 at 93.31-47). 18 It is apparent that the applicant sought to rely upon the Dorey affidavits and Neugebauer affidavits only to establish the nature and extent of AVN and Mr Neugebauer's interest in the relief which they seek, including that: (1) AVN had lobbied governments on issues concerning vaccine safety, including pertaining to childhood vaccination; (2) AVN had corresponded with the Secretary to voice its concerns about the provisional approvals of the Three Vaccines and the Children Decision; (3) AVN and Mr Neugebauer held particular opinions about the risks associated with the Three Vaccines, the administration of a COVID-19 vaccine to children, and vaccines generally; (4) AVN and Mr Neugebauer considered those opinions to be supported by scientific evidence; and (5) Mr Neugebauer's interests were adversely affected by the decisions in question in the Mandamus Case and the Judicial Review Case. The applicants did not seek at this stage of the proceeding to rely upon the material for a hearsay purpose; nor did they seek to establish the veracity of the opinions which they held. In so far as the respondent contends that the evidence is not relevant on the ground that it does not suffice to establish standing or that the applicants are persons aggrieved for the purposes of the AJDR Act, the objection is overruled. That presupposes the answer to the very question raised by the notice of objection to competency. 19 In those circumstances, I consider that the following evidence to which objection was taken (including for clarification, those portions of the affidavit evidence where the respondent was content for the evidence to be admitted subject to the s 136 Limitation and did not otherwise press any objection) should be admitted subject to the s 136 Limitation: (1) January Dorey affidavit: paragraphs 4(a) and 8-23, and annexure MD-03 (A profile of the Australian Vaccination Network 2012, report compiled on behalf of AVN by Trevor Wilson, April 2013); (2) February Dorey affidavit: paragraphs 7-9 inclusive, 23(b)-(d), 24(b), 26 umbrella paragraph and 26(c), and Annexures MD-5, MD-7 to MD-23; (3) First Neugebauer affidavit: subparagraphs (c), (d), (h), (i), and (j)(vii) of paragraph 2, as well as Annexure MN-02; (4) Second Neugebauer affidavit: the fifth paragraph of Annexure MN-08; and (5) Third Neugebauer affidavit: paragraphs 3, 5, Annexure MN-09 (all emails from and to Mr Neugebauer at pp. 6 to 75 (JRCB 758-827) inclusive save for the email at pp. 6-7 (JRCB758-759) from the Department for Child Protection dated 14 February 2022), and the seventh to ninth paragraphs of Annexure MN-12. 20 However, I uphold the objections to paragraph 7 of the January Dorey affidavit and the penultimate and final sentences in paragraph 8 of the February Dorey Affidavit insofar as they asserted that the lobbying activities by or on behalf of AVN led to the passage in the Parliament of an amendment to the Child Care Payments Bill 1997 (Cth). That evidence is objectionable for a number of reasons, including that it is inadmissible opinion evidence and an inadmissible conclusory statement. Equally and for the same reasons, I uphold the objection to paragraph 26(b) of the February Dorey affidavit. The opinions and conclusory statements otherwise objected to in paragraph 26 are received only as statements of Ms Dorey's belief, in line with my ruling. 21 Finally, the Secretary relied upon the two affidavits of Grace Ng, solicitor, affirmed on 7 March 2022 and 18 March 22 (the first Ng affidavit and second Ng affidavit respectively). These were read without objection.

3.1 AVN's objectives and activities 22 The AVN was founded by Ms Dorey. It is clear that Ms Dorey came to feel very strongly about the risks of vaccination, following what was in her opinion a severe and ongoing adverse reaction suffered by one of her children to vaccines administered to him as an infant. She referred to questions about whether her son could have had more in life, which she says will always haunt her. She also refers to other members of AVN or their children who she believes have suffered similar experiences. 23 AVN is an incorporated association which was registered on 25 November 1994 under the Associations Incorporation Act 2009 (NSW) (February Dorey affidavit at [1] and [4]). The constitution of the AVN (the AVN Constitution) (Annexure MD-1 to the January Dorey affidavit) was filed in its current form with New South Wales Fair Trading on 7 March 2014. At that time, AVN was trading as the "Australian Vaccination-Skeptics Network". 24 The AVN Constitution provides for a committee to be elected by annual general meeting which consists of a secretary, treasurer, president, and other committee members (cl 14). That committee is vested with powers for the control and management of the affairs of the association (cl 13). Under cl 2 of the AVN Constitution, a person is eligible to be a member if she or her is a natural person, supports AVN's objectives, and has applied for and been approved for membership of the AVN by the committee in accordance with cl 3. Clause 11 of the AVN Constitution also provides for members to be expelled or their membership suspended if the committee is satisfied, among other things, that a member of the association has wilfully acted in a manner prejudicial to the interests of the association, subject to a right of appeal under cl 12. As at 29 January 2022, the AVN had some 1933 members. 25 Clause 36 of the AVN Constitution provides that the funds of the association are to be derived from annual membership subscriptions, donations, and, subject to any resolution passed in a general meeting, such other sources as the committee determines. Under clause 37, the funds of the association are to be used in pursuat of its objects in such manner as the committee determines. 26 AVN placed particular emphasis upon its objectives as set out in clause 43 of the AVN Constitution in support of the contention that it has standing and/or is a "person aggrieved" for the purposes of the ADJR Act. Clause 43 provides as follows: The objectives of this organisation are: 1) To facilitate the sharing of information on vaccination and related topics among members. In this respect, without limiting the source or content of the information, and in recognition of the fact that information which is critical of vaccination is typically not as readily shared by mainstream sources as that which is supportive, to seek to provide balance by actively facilitating the sharing of information which is not been disseminated by popular mainstream information services, but which may be of interest to members. 2) To facilitate the discussion of vaccination and related topics among members, including the sharing of personal or family experiences, with a particular emphasis on respect and tolerance for all points of view. 3) To encourage members and supporters to seek information on vaccination and related topics from a variety of sources and viewpoints. 4) To encourage and facilitate among members the critical evaluation, from a consumer perspective, of mainstream advice and opinion on vaccination and related topics. 5) To uphold the principle of "informed choice" on vaccination and related topics, and to promote respect for the right of each individual (members and non-members) to make such a choice. 6) To represent members' questions, concerns, and grievances, with respect to vaccination and related topics, to appropriate bodies outside of the organisation. 7) To campaign for the rights of members to make informed choices regarding vaccination and related topics, and act on those choices without fear of persecution, discrimination or disadvantage. 8) To build relationships and exchange information with individuals and organisations involved with vaccination and related topics. 27 With respect to the activities of AVN, Ms Dorey explained that: … the AVN provides information to its members through newsletters, social media sites, the internet and on the telephone to help them access scientifically based data so that they can make an informed choice about vaccination. We also support and advocate for members who are being discriminated against as a result of their vaccination decision or the decision they made for their children. (January Dorey affidavit at [5].) 28 With respect to the AVN website, Ms Dorey explained that AVN "has always tried to provide a one-stop-shop where those who seek information and support about vaccines will be able to find it", including legal rights, scientific information on vaccine safety and efficacy, a source for local source networks, adverse vaccine reaction reporting facilities, and news on COVID-19 and other vaccines (February Dorey affidavit at [23]). Examples of articles published on the website were annexed to the February Dorey affidavit. 29 Ms Dorey deposed that in 1998, AVN lobbied members of Parliament for the federal government to introduce into the Child Care Payments Bill 1997 (Cth), a "'conscientious objector' clause; which meant that parents who made an informed choice not to vaccinate their children would not necessarily be cut off from welfare payments if they were deemed conscientious objectors" (January Dorey affidavit at [7]). In the February Dorey affidavit, Ms Dorey also referred to a dozen letters and submissions made between 2002 and 2019 to federal and state parliamentary committees, members of Parliament, and government agencies, opposing, for example, legislative amendments to mandate vaccination of children, and setting out views which seek to challenge the efficacy and safety of vaccines. 30 Ms Dorey also gave evidence that: The AVN is the peak vaccine organisation in Australia. It is recognised as a leader amongst other organisations in Australia that have similar objectives to ours. There are several reasons for this, including that; a) The AVN has existed for 28 years, since 1994; … c) The AVN is the sole national organisation of its kind in Australia, whereas similar organisations such as Vaccine Information South Australia and Vaccination Answers Informed Sources (in Brisbane) focus only on their respective State or Territory of origin; and d) The AVN is a leading source of information in respect of vaccination. (February Dorey affidavit at [26].) 31 In line with my earlier rulings on evidence, Ms Dorey's evidence that AVN "is the peak vaccine organisation in Australia", "is recognised as a leader" among other Australian organisations with similar objectives, and "is a leading source of information in respect of vaccination", is received as evidence only of Ms Dorey's understanding or belief. That evidence is not sufficient to establish that AVN is regarded by governments or others as "the peak vaccine organisation in Australia" or that it is otherwise recognised in the manner to which Ms Dorey referred, as I later find.

3.2 Correspondence relating to the Three Vaccines and the Children Decision 32 AVN also relied upon correspondence between Ms Dorey on behalf of AVN and the Department of Health and others, submitting that AVN's special interest is reflected in the correspondence. The particular correspondence relied upon by AVN can be summarised as follows. 33 On 27 May 2021, Ms Dorey on behalf of AVN wrote to the Minister for Health and Aged Care (the Minister) about its concerns around the COVID-19 vaccination rollout "demand[ing], based on the precautionary principle, that the current mRNA and viral vector vaccination experimental trial be immediately halted until independent scientific safety and efficacy evaluations can be unequivocally established" (JRCB1167). The letter argued that the vaccines were unnecessary and the risks of adverse reactions were too high - views which it said were backed up by scientific studies - and "request[ed] urgent action in response to the above information, ensuring a halt to the rollout of the COVID-19 vaccines for the safety of all Australians" (JRCB1170). 34 The Director of the Department of Health (the Director) responded on behalf of the Minister by letter dated 8 June 2021, advising among other things that: The government acknowledges you may have questions concerning the COVID-19 vaccine rollout. It is a large and complex project, and the information you are seeking may change over time -that is why we strongly encourage you to stay up-to-date on all news and announcements, by regular checking the Department Of Health website at: www.health.gov.au. COVID-19 vaccination will not be mandatory in Australia, but it is important that everyone who can get it, does get it, to help keep themselves and others safe. Anyone with questions about the benefits of being vaccinated is encouraged to talk to their doctor or pharmacist. The safety of the Australian population has always been the Government's highest priority. For this reason, decisions regarding COVID-19 vaccines have been, and continue to be, based on the expert medical advice of the Australian Technical Advisory Group on Immunisation (ATAGI). The government is working closely with ATAGI, the Therapeutic Goods Administration (TGA) and all state and territory health departments to ensure that monitoring of COVID-19 vaccine safety is of the highest possible standard in Australia. It is important for Australians to have access to credible and timely information about COVID-19 vaccines. The Department of Health is communicating regularly about the progress, safety and effectiveness of COVID-19 vaccines. (JRCB1171.) 35 On 18 June 2021, Ms Dorey wrote to the Minister complaining that the response from the Director did not address any of the issues raised in her earlier letter and requesting again that "the Australian Government immediately cease its obviously harmful and deadly campaign, using experimental COVID injections on unsuspecting men, women and now, children until proper scientific studies have been conducted." The letter continued: Our demands are as follows: 1- An immediate cessation of the experimental COVID shots until such time as they have been independently and scientifically tested for the long-term efficacy, safety and ability to prevent transmission … … 3- These trials should be designed, conducted and overseen by independent scientists who have no ties - financial or otherwise - with any sector of the pharmaceutical industry. (JRCB1174.) 36 The letter further asked for a response within seven days of receipt of the letter and stated that in the absence of a response addressing AVN's concerns (JRCB1175): we would feel that we have no option but to consider legal action against you yourself, Minister Hunt, in the form of a private prosecution and against the Government to seek injunctive relief to immediately stop this current experiment on the Australian population - an experiment which you yourself called the world's largest clinical trial. It is indeed that but it is a trial where those who are enrolled are unaware of the fact that they are being used as guinea pigs and that their outcomes are neither being studied nor are they even being recorded. 37 On 1 August 2021, the Acting Assistant Secretary of the COVID-19 Vaccine Task Force responded on behalf of the Minister, advising that: You can be assured that the Government, along with the states and territories, is taking an evidence-based approach to COVID-19, and is committed to keeping Australians safe. Before any COVID-19 treatment is approved for use in Australia it will be subject to the Therapeutic Goods Administration (TGA) stringent assessment and approval processes, after being tested in large clinical trials on thousands of people. The TGA rigorously assesses all medical products for safety, quality and effectiveness. COVID-19 can affect anyone, and there is a significant risk of developing more severe symptoms of COVID-19, particularly for those who are elderly and/or have serious underlying health problems. These can include respiratory and cardiac concerns, and a requirement for mechanical ventilation. For some who been infected with the SARS-CoV-2 virus, they continue to have a wide range of ongoing health problems. The primary purpose of COVID-19 vaccines is to prevent individuals from developing severe disease and death. The Australian Technical Advisory Group on Immunisation (ATAGI) provides the Government with advice on clinical considerations for the rollout of the COVID-19 vaccination program in Australia, ensuring that the benefits outweigh the risks for each population group. … The TGA undertook an independent and rigorous assessment of available data for the Pfizer and AstraZeneca vaccines, as they do with all medicines and vaccines approved for use in Australia. The data provided to the TGA was comprehensive and included clinical trial studies, nonclinical and toxicology studies, chemistry, manufacturing and risk management. The TGA provisionally approved these vaccines after a complete assessment of all data, which will only occur if a COVID-19 vaccine is found to be safe and effective. The TGA continues to monitor the safety of vaccines after they are registered in Australia so that any safety concerns can be detected and responded to. Active surveillance is also occurring through the AusVaxSafety surveillance system, which sends follow-up messages to recipients of COVID-19 vaccines to ask if they have experienced any potential side effects. Like all medicines, vaccines may have side effects, such as pain and soreness at the injection site, but the majority of side effects are mild and resolved within a few days. 38 The letter continued by responding to certain other matters raised in Ms Dorey's letter. 39 On 26 November 2021, Ms Dorey also wrote on behalf of AVN addressed to Dr Murphy, the Secretary, repeating her concerns about the COVID-19 vaccines and the demands made in her letter to the Minister on 18 June 2021 (JRCB1179). Ms Dorey again advised that in the absence of an adequate response, AVN would consider legal action against the government. This letter was sought to be relied upon as a "letter of demand". 40 On 16 December 2021, Ms Dorey wrote a further letter on behalf of AVN addressed to Dr Murphy, referring to her earlier correspondence with him and the Minister (JRCB1184). In that letter, Ms Dorey stated that AVN believes that the registrations of the Three Vaccines ought to have been suspended or cancelled on the "non-exhaustive basis that there is information and evidence that each of the Registrations have caused historically unprecedented adverse events including death, illnesses and injuries that warrant suspension or cancellation and that insufficient weight has been placed on that information" (JRCB1185). The letter set out the information and articles on which AVN relied in reaching those views and impressed the urgency of the situation on Dr Murphy. The letter concluded that: The AVN requires that you respond to this correspondence confirming that you will: a) expressly consider suspending or cancelling the Registrations; b) that you will suspend the provisional approval of the Pfizer Registration insofar as it relates to persons under the age of eleven (11) pending further investigation; and c) that you will provide, publicly into our office, reasons for your decisions relating to the above. Absent a response to this correspondence by no later than 3:00pm on Friday, 24 December 2021, the AVN will have no choice other than to seek the Court's intervention. 41 With respect to the Children Decision, AVN relied upon a letter dated 5 January 2022 from Mr Fam, solicitor for AVN, to the Secretary (SuppCB at p. 28, tab 2), which it sought to characterise as "the genuine steps letter of demand" (T23/3/22 at p. 7.42-45). In that letter, Mr Fam noted that no response had been received to AVN's letter of 16 December 2021. The letter further stated that the Australian Public Assessment Report for Tozinameran (mRNA Covid-19 vaccine), which purported to justify the making of the Children Decision by the TGA, contained "fundamental errors" rendering it invalid, which could be corrected by the Secretary immediately revoking the Children Decision. The letter then sought to elaborate upon the alleged errors including an alleged failure to take into account likely significant underreporting of adverse events and contended that there was no genuine public health need to vaccinate 5 to 11 year old children. Mr Fam sought confirmation within 14 days of the date of the letter that the Children Decision would be revoked and advised that, in the absence of such confirmation, AVN would seek judicial review remedies in the nature of mandamus, certiorari, and urgent injunctive relief from the Federal Court.

3.3 The present proceeding 42 The originating application was filed on 1 February 2022, with the amended application filed on 8 March 2022. 43 By the Application, first, AVN seeks orders in the nature of mandamus with respect to decisions made by the Secretary pursuant to s 25 of the TG Act in 2021 (the Mandamus Decisions) to provisionally approve the registration of the COVID-19 vaccines separately sponsored by Pfizer (initially for individuals aged 16 years and over and later, for individuals aged 12 years and over), AstraZeneca Pty Ltd, and Moderna Australia Pty Ltd (collectively, the Three Vaccines). Specifically, AVN seeks orders: … directing the respondent to exercise his statutory duty and powers according to law under sections 9A(1), 29D, 30(1)(a) and 30(2)(a) of the [TG Act] as to whether to suspend or cancel the provisional approval already given in respect of each of the 3 Vaccines… to be exercised within 28 days of the date of the Court's decision. (See [2] of the relief sought in the Application.) 44 Further, or in the alternative, AVN seeks declaratory relief in the following terms: a declaration that the respondent should exercise his statutory powers according to law under sections 29D, 30(1)(a) and 30(2)(a) of the [TG Act] as to whether to suspend or cancel the provisional approval already given in respect of each of the 3 Vaccines … to be exercised within 28 days of the date of the Court's decision. (See [3] of the relief sought in the Application.) 45 Importantly, at the hearing Mr Robinson SC for AVN (and Mr Neugebauer) clarified that mandamus was sought requiring the Secretary to consider the exercise of the statutory powers in question, and not an order requiring the Secretary to exercise his statutory powers. However, based on the evidence on which it would rely if the matter proceeded to trial, AVN contended that "[i]f the respondent performed his public duty according to law based on the information and expert reports now provided to him by the applicant and the joinder applicant, then suspension or cancellation might well follow" (Applicants' submissions in reply filed on 21 March 2022 (AR) at [22]). 46 The grounds on which AVN seeks mandamus are that, since provisional approval of the Three Vaccines, the Secretary "has failed to reasonably obtain, monitor, consider, assess, evaluate and balance data which was or should have been before [the Secretary] about the [Three] Vaccines". The data concerned is alleged to establish two propositions: that the respondent's failure to cancel the provisional registration of the Three Vaccines creates an imminent risk of death or serious illness or serious injury, and that there now exists an "unacceptable balance" between the quality, safety and efficacy of these vaccines in the sense that the balance is so far removed from "the required standard, norm and expectation". AVN contends that as a result the Secretary ought by now reasonably to have considered whether or not to suspend or cancel the provisional registration of each vaccine and has a continuing statutory duty to do so. In failing to exercise any of the statutory powers to cancel or suspend provisional registration of the Three Vaccines, AVN alleges that the Secretary has breached the duty under s 9A(1) of the TG Act "to cause to be maintained" the Australian Register of Therapeutic Goods (the Register). 47 Secondly, AVN seeks an order quashing or setting aside the Children Decision made by the respondent on or about 3 December 2021 to grant provisional approval with respect to Comirnaty (tozinameran), being the COVID-19 vaccine sponsored by Pfizer, for use among children aged 5 to 11 years from 10 January 2022. 48 Thirdly, AVN seeks an order quashing or setting aside any determination made by the Secretary pursuant to s 22D of the TG Act to the effect that an indication of "the proposed Pfizer vaccine" was the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition for children aged 5 to 11 years of age.

LEGISLATIVE FRAMEWORK: THE TG ACT 49 The objects of the TG Act are set out in s 4 and include "the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods" that are used in Australia or exported from Australia. As such, the national system of controls referred to in s 4 is not only concerned with the quality, safety and efficacy of therapeutic goods, but also with their timely availability: Alphapharm Pty Ltd v Smithkline Beecham (Australia) Pty Ltd [1994] FCA 161; (1994) 49 FCR 250 (Alphapharm) at 261 (Davies J) and 273 (Gummow J). 50 In furtherance of these objects, the TG Act makes provision relevantly for the registration and provisional registration of therapeutic goods on the Register. Thus, under s 9A(1) of the TG Act: The Secretary is to cause to be maintained a register, to be known as the Australian Register of Therapeutic Goods, for the purpose of compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans. 51 Importantly, as the Secretary submits, the effect of registration or provisional registration of therapeutic goods on the Register is not to mandate their use. Rather, it is to permit the lawful importation, manufacture and supply of those goods in Australia, and the lawful exportation from Australia of those goods, by persons in relation to whom the medicine is registered where such conduct would otherwise contravene the prohibitions in ss 19B and 19D of the TG Act. The registration of therapeutic goods is also subject to any Ministerial determinations setting out conditions and to any conditions imposed by the Secretary by notice in writing (s 28, TG Act). Registration may also be cancelled or suspended, including for non-compliance with a condition of registration under ss 29D(1)(b) and 30(1)(da), TG Act. 52 The registration (and listing) of therapeutic goods is dealt with in Part 3-2 of the TG Act (ss 15A-31F) and in the Therapeutic Goods Regulations 1990 (Cth) (the TG Regulations). Relevantly, first, where an application is made under s 22C for a provisional determination relating to a medicine of a kind prescribed by regulation, the Secretary has a discretion under s 22D to make the determination if satisfied that the criteria prescribed by regulation are met in relation to the medicine. Those criteria are prescribed by reg 10L of the TG Regulations (see s 22D(2), TG Act). The term "medicine" is defined in s 3 to mean "therapeutic goods (other than biologicals) that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human" (emphasis added). As such, "medicine" includes vaccines for humans as these are designed to create an immune response. A provisional determination may remain in force for an initial period, being 6 months (subject to one possible extension) or, if an application for provisional registration is made under s 23, until the s 23 application is finally determined, withdrawn, lapses, or is the subject of written notice to the Secretary by the sponsor that it wishes to treat the application as having been refused (s 22E, TG Act). 53 Secondly, if a provisional determination is made, a person may apply to the Secretary for provisional registration of the therapeutic goods (ss 23 and 23AA, TG Act). If that application passes preliminary assessment as required by s 23B(1), then under s 25(1) the Secretary must evaluate the goods for registration. In the case of an application for provisional registration of a medicine, in undertaking that evaluation the Secretary is required by s 25(1)(d) to have regard among other things to: (i) whether, based on preliminary clinical data, the safety and efficacy of the medicine for the purposes for which it is to be used have been satisfactorily established; and (ii) whether the quality of the medicine for the purposes for which it is to be used has been satisfactorily established; 54 The Secretary is also required to have regard inter alia to whether the goods conform to any applicable standard (s 25(1)(f)) and any other matters which the Secretary considers relevant (s 25(1)(k)). Section 25(2A) requires that an evaluation of a good under the section must be completed within the period (if any) prescribed by the regulations made under s 63(2)(da). 55 Thirdly, the Advisory Committee on Vaccines established by reg 39F of the TG Regulations may, at the request of the Minister or the Secretary, provide advice and make recommendations to the Minister or Secretary about the following matters under reg 39G: (a) the safety, quality and efficacy of vaccines, including in relation to pharmacovigilance; (b) the registration of a vaccine; (c) the variation of an entry for a vaccine in the Register; (d) the continued retention of a vaccine in, or the removal of a vaccine from, the Register; (e) risk assessment and risk management of vaccines; (f) any other matter (whether or not related to a vaccine), including a mater related to standards. 56 The Advisory Committee on Vaccines is a committee comprised of up to 10 experts in the fields prescribed under reg 39H(3) of the TG Regulations, namely: (a) immunology; (b) virology; (c) bacteriology; (d) infectious diseases in adults or children; (e) public health; (f) epidemiology or biostatistics; (g) vaccine program implementation; (h) the provision of immunisation treatment by an individual; (i) paediatrics; (j) nursing. 57 Fourthly, once an evaluation has been conducted, the Secretary must decide whether to register or not to register the goods (s 25(3), TG Act). Notification of the decision must be given to the applicant within 28 days (ss 25AB and 25AC). However, reasons for the decision must be given to the applicant only where the decision is not to register the goods (s 25AC). 58 Fifthly, the TG Act recognises that persons other than the sponsor may have interests which may be taken into account in the making of the decision, as Davies J pointed out in Alphapharm at 261. Thus, s 60(6) of the TG Act recognises that notice may be given to persons whose interests may be affected in addition to the sponsor. Examples of such persons may include the owners of a relevant patented process, persons with a medical condition that might be treated if the drug is registered, manufacturers or distributors of the drug, and organisations representing an element of the public interest which wish to put forward a view on the use, testing or evaluation of a particular drug (ibid). However, as Davies J also pointed out in Alphapharm at 261: the Act makes no provision for the joinder of persons in the decision-making process. … Applications for registration are not advertised. There is no provision for the hearing of witnesses or for the hearing of any interested parties. The procedure of investigation, testing and evaluation is undertaken by experts in the field. And that process is confidential, as the litigation in the Smith Kline & French cases sufficiently demonstrates. ... … An object is to ensure that drugs which are imported are suitable for use in humans in Australia. Another object is to ensure that drugs which are suitable are registered or listed and become available in Australia for public use as soon as is practicable: see ss 4 and 17 of the [TG Act]. The Regulations specify times within which certain evaluations must be made and certain applications decided and a remedy in the nature of damages is provided for failure to make certain decisions within the specified time. And, as I have pointed out, the Act and Regulations set up a structure, including the Australian Drug Evaluation Committee, for the carrying out of the necessary inquiries and for the making of skilled judgments as to the suitability or otherwise of a drug. 59 Similarly, Gummow J held in Alphapharm at 280 that: There is no requirement for the provision of an opportunity to any third parties to be heard upon an application for registration. Reasons are required only where the decision is not to register (s 25(3)). Nor is there a requirement that a decision under s 25(3) to register goods be published generally. I have referred to other provisions which provide for notification of decisions in the Gazette; see also s 60(2)(a) which gives to a person whose interests are affected by a decision particulars of which are so notified in the Gazette, 90 days thereafter to request reconsideration. The provisions in s 61 for the release of therapeutic goods information are, so far as is relevant to the present case, limited to the provision of information in relation to therapeutic goods which are already on the Register. Further, an interpretation of the legislation which treated a third party as a person interested in, in the sense of opposed to, a grant of registration would not sit well with that object of the legislation which is concerned with the timely availability of therapeutic goods, after evaluation by an expert body and pursuant to a "complex and delicate administrative scheme": cf Block v Community Nutrition Institute 467 US 34 at 348 (1984). (Cited with approval by R D Nicholson J in Edwards v Australian Securities and Investments Commission [1997] FCA 38; (1997) 72 FCR 350 at 366-367 (Lee and Carr JJ agreeing at 351).) 60 In the sixth place, it is a criminal offence under s 29A of the TG Act for a person in relation to whom therapeutic goods are registered or listed to fail to advise the Secretary of information indicating, among other things, that the use of the goods in accordance with the recommendations for their use may have an unintended harmful effect or that the quality, safety or efficacy of the goods is unacceptable. That conduct may also give rise to a civil penalty under s 29AA. 61 In the seventh place, if a decision has been made under s 25(3) to register the goods, the Secretary is vested with discretionary powers to suspend or cancel the registration. In particular, s 29D provides that the Secretary may, by written notice to a person in relation to whom therapeutic goods are included in the Register, suspend the registration or listing of the goods if satisfied, for example, that "there is a potential risk of death, serious illness, or serious injury" if the therapeutic goods continue to be included in the Register (s 29D(1)(a)(i)). Furthermore, the Secretary may, again by written notice to a person in relation to whom therapeutic goods are included in the Register, cancel the registration of the goods if it appears to the Secretary that the failure to do so "would create an imminent risk of death, serious illness or serious injury" or "the quality, safety or efficacy of the goods is unacceptable" (ss 30(1)(a) and 30(2)(a) respectively). No express duty is imposed on the Secretary to exercise his statutory powers under ss 29D(1) or 30, or to consider doing so. 62 The Secretary submitted that no implied duties on the Secretary to that effect exist either. However, it is unnecessary for me to decide whether, as the applicants wish to contend, there are circumstances in which an implied duty to do so might arise, given my findings in any event as to standing. It would also be undesirable to decide that question in the context where that issue was not clearly raised by the notice of objection to competency. 63 Finally, by virtue of ss 29E(1) and 30(5) of the TG Act, the suspension or cancellation of registration of therapeutic goods operates prospectively only: see also Alphapharm at 280 (Gummow J). As the Secretary submits, this has significance in particular for Mr Neugebauer's application for joinder insofar as it relates to the Mandamus Case.

5.1 Standing and "matter" under Chapter III of the Constitution 64 The most recent discussion by the High Court of the interrelated questions of standing and "matter" under Chapter III of the Constitution is found in the decision in Hobart International Airport Pty Ltd v Clarence City Council [2022] HCA 5; (2022) 96 ALJR 234 (Hobart International). Senior Counsel for the applicants submitted at the hearing that the judgments in Hobart International are not helpful in setting out the principles relevant to the "special interest test" in the present case because that decision addressed questions of standing and matter in the context of very different rights and interests from those in the present case. At issue in the appeal in Hobart International was the standing of respondent local councils (the Councils) to seek declaratory relief as to the obligations of various entities, which were leasing parts of the airport from the Commonwealth, to make ex-gratia payments to the Councils in lieu of council rates pursuant to an obligation under cl 26.2(a) of each lease. Despite the Councils being third parties to the leases, the majority (Kiefel CJ, Gageler, Keane, Gordon and Gleeson JJ (Edelman and Steward JJ dissenting)) dismissed the appeal from the Full Court of the Federal Court and held that the Councils had standing to seek the declarations. It is true, therefore (as AVN submits), that the Councils' interest in the subject matter of the dispute in Hobart International was very different from the applicants' alleged interests in the subject matter of the present proceeding. However, the reasons of the various members of the High Court in Hobart International address relevant matters of general principle. As such, I reject AVN's submission to the effect that the case can be confined to its facts and is not of assistance in resolving the jurisdictional issues in the present case. 65 First, turning to the relevant principles, the starting point is Chapter III of the Constitution which deals with the judicial power of the Commonwealth. Relevantly, s 77 in Chapter III of the Constitution vests power in the Parliament to define the jurisdiction of any federal court other than the High Court with respect to any of the "matters" mentioned in ss 75 and 76. Sections 75 and 76 respectively vest original jurisdiction in the High Court and empower the Parliament to confer original jurisdiction on the High Court, over "matters" of the nature specified. These include matters in which a writ of Mandamus or prohibition or an injunction is sought against an officer of the Commonwealth (s 75(v)) and any matter arising under any laws made by the Parliament (s 76(ii)). 66 Section 19(1) of the FCA Act in turn provides that the Court has such original jurisdiction as is vested in it by laws made by the Parliament. Section 39B of the Judiciary Act is such a law and confers original jurisdiction on the Federal Court with respect to the same subject matter and in the same terms as ss 75(v) and 76(ii) of the Constitution subject to an exception not presently relevant. Relevantly also, s 8 of the ADJR Act confers jurisdiction on the Federal Court to hear and determine applications made to it under that Act, which include applications made under ss 5 and 7 of the ADJR Act. I set out the terms of those provisions later in these reasons. 67 Secondly, a "matter" for the purposes of Ch III of the Constitution has two elements: "the subject matter itself as defined by reference to the heads of jurisdiction set out in Chapter III [of the Constitution], and the concrete or adequate adversarial nature of the dispute sufficient to give rise to a justiciable controversy": CGU Insurance Ltd v Blakeley [2016] HCA 2; (2016) 259 CLR 339 at [27], quoted with approval in Hobart International at [26] (Kiefel, Keane and Gordon JJ). It is not in issue here that the applicant's claims for relief satisfy the first element, being the subject matter requirements in s 39B of the Judiciary Act which relevantly mirror ss 75(v) and 76(ii) of the Constitution. 68 As to the second element, it has long been established that "there can be no matter within the meaning of [Chapter III of the Constitution] unless there is some immediate right, duty or liability to be established by the determination of the Court": Re Judiciary and Navigation Acts (1921) 29 CLR 257 (In re Judiciary) at 265 (Knox CJ, Gavan Duffy, Powers, Rich and Starke JJ) (emphasis added); recently affirmed, e.g., in Hobart International at [29] (Kiefel CJ, Keane and Gordon JJ) and [79] (Edelman and Steward JJ). Thus, the Parliament cannot authorise a federal court "to make a declaration of law divorced from any attempt to administer that law" or "to determine abstract questions of law without the right or duty of any body or person being involved" (In re Judiciary at 266 and 267 respectively). 69 Thus, Gageler and Gleeson JJ explained in Hobart International that: 47. … The central conception of a matter is of a justiciable controversy between defined persons or classes of persons about an existing legal right or legal obligation. The controversy is justiciable if it is capable of being resolved in the exercise of judicial power by an order of a court which, if made, would operate to put an end to the question in controversy by the creation of "a new charter by reference to which that question is in future to be decided as between those persons or classes of persons" [quoting R v Trade Practices Tribunal; ex parte Tasmanian Breweries Pty Ltd (1970) 123 CLR 361 at 374]. Conversely, a controversy between defined persons or classes of persons about an existing legal right or legal obligation which is not capable of being resolved in the exercise of judicial power by an order of the court is not justiciable and is not a matter. 48. That was the point made be Gleeson CJ and McHugh J when they said in Abebe v Commonwealth [[1999] HCA 14; (1999) 197 CLR 510 at 527]: A "matter" cannot exist in the abstract. If there is no legal remedy for a "wrong", there can be no "matter". A legally enforceable remedy is as essential to the existence of a "matter" as the right, duty or liability which gives rise to the remedy. Without the right to bring a curial proceeding, there can be no matter. (Emphasis added.) 70 Thus, the question of whether a sufficient interest to establish standing has been established involves no element of discretion although, as I explain below, it does involve questions of degree: Hobart International at [66] (Gageler and Gleeson JJ); see also, e.g., Onus at 75 (Brennan J), quoting Baker v Carr (1962) 369 US 186 at 204; Kuczborski v Queensland [2014] HCA 46; (2014) 254 CLR 51 at 109 [184]-[186] (Crennan, Kiefel, Gageler and Keane JJ). 71 Thirdly, as is evident from these observations, questions of standing in the sense that the person claiming the remedy has a sufficient interest in enforcing the right, duty, or liability are inextricably intertwined with the notion of a "matter" in the Chapter III sense. As Gageler and Gleeson JJ further explained in Hobart International (in taking up the point made in the passage from Abebe v The Commonwealth [1999] HCA 14; (1999) 197 CLR 510 (Abebe) quoted in the preceding paragraph): 49. … the justiciability of a controversy between defined persons or classes of persons about the content of an existing legal right or obligation depends on: (1) the power of a court to make an order that would operate to resolve the controversy between those persons; and (2) the right of one or more of those persons to seek that order from that court. Standing, in the sense of a right to seek from a court an order that would operate to resolve the controversy, is in that way inseparable from justiciability and, therefore, is intrinsic to the existence of the matter without which the federal jurisdiction of the court to make the order cannot exist. That is what has been meant when it has often been said that standing is "subsumed within the constitutional requirement of a matter". (Emphasis added; footnotes omitted.) 72 In the fourth place, what is required to establish standing will vary according to the relief sought: Hobart International at [32] (Kiefel CJ, Keane and Gordon JJ) (referring with approval in the accompanying footnote to ACF at 511). With respect to the relief sought in Hobart International, their Honours held that: 32. … Here, the Councils seek declaratory relief. The breadth of the jurisdiction to grant declaratory relief was considered by Gibbs J in Forster v Jododex Australia Pty Ltd [ (1972) 127 CLR 421 at 437-438]. The question must be real, not theoretical. There must be a proper contradictor - someone presently existing who has a true interest to oppose the declaration sought. And the applicant must have a "sufficient" or "real" interest in obtaining the relief. There is no requirement that an applicant for declaratory relief have a cause of action in order to obtain it. Those principles are not exhaustive. These appeals turn on the nature and adequacy of the Councils' interest in the resolution of the dispute. (Footnotes omitted.) 73 As to certiorari, Gummow J observed in Australian Institute of Marine and Power Engineers v Secretary, Department of Transport (1986) 13 FCR 124 (Marine and Power Engineers) at 131-132 (in the context of considering what is meant by "person aggrieved" under the ADJR Act): What of the general law? The rules as to locus standi were by no means uniform as between the various prerogative writs, but the concept of "grievance" as providing locus standi was embedded in the rules which controlled the issue of writs of certiorari. And, as Ellicott J explained in Tooheys Ltd v Minister for Business and Consumer Affairs (1981) 54 FLR 421 at 437-438, the procedures established by the ADJR Act clearly were intended "in part" to be in substitution for the more complex prerogative writ procedures. At common law it became established that, whilst the court even in other cases had a discretion to issue certiorari, it would do so ex debito justitiae if the application was made by "an aggrieved party", who was not merely one of the public and who had "a particular grievance of [his] own" … What needs to be emphasised is that even at common law it was by no means apparent that "grievance" necessarily involved injury to property or present legal interests or "special damage" in any technical sense. Nor was it essential that the aggrieved person be a "party" to the administrative decision he sought to have quashed by certiorari, if he otherwise had sufficient standing. (Citations omitted.) 74 I agree with the Secretary that there is little, if any, practical difference between establishing a "peculiar grievance" in the subject matter in the context of an application for certiorari and establishing a "special interest" to enforce a public duty. As Brennan J held in Kioa v West (1985) 159 CLR 550 (Kioa) at 621: The exercise of a power affecting interests falling short of legal rights may single out the individual whose interests are affected but he has no standing to challenge the validity of the exercise of the power unless he has a sufficient interest to give him standing in public law. Standing is an incident of a legal right, but standing is not an incident of an interest falling short of a legal right. … At common law an "aggrieved party" has standing to seek certiorari to challenge an administrative decision, and an "aggrieved party" is one who has a "peculiar grievance" different from any grievance felt by the public at large: Reg. v. Town of Glenelg [[1968] SASR 246 at 251-252] … The term includes "any person whose interests may be prejudicially affected by what is taking place": per Lord Denning MR in Reg. v. Liverpool Corporation; Ex parte Taxi Fleet [[1972] 2 QB 299 at 308-309]. And in cases concerned with the enforcement of public law duties of the suit of persons who had no private law right to enforce, this Court held that a plaintiff had standing if he had a special interest in the subject-matter of the litigation: [ACF] and [Onus]. An adverse and distinctive affection of the applicant's interests by the exercise of the power which he seeks to impugn gives rise to a peculiar grievance or special interest in the subject-matter of the litigation. 75 In any event, no party suggested that there was any difference in what the applicants had to prove in order to establish standing to seek certiorari to quash the Children Decision as opposed to their claims for mandamus or declaratory relief. 76 In the fifth place, AVN submitted at the hearing that the present case turned upon whether the applicant and/or the joinder applicant had a "special interest" beyond that of an ordinary member of the public on the basis that relief was sought with respect to obligations arising in a public law context, as opposed to whether they had a "real" or "sufficient" interest in seeking relief being (in AVN's submission) the applicable test in the private law context. 77 Different approaches to this issue emerge from a consideration of the judgments in Hobart International. The sharp dichotomy for which the applicants here contend is not reflected in the reasons of Kiefel, Keane and Gordon JJ, who held that: 33. The requirement that an applicant for declaratory relief have a "sufficient" or "real" interest in obtaining the relief has work to do in both public and private law contexts. "However, the requirement applies differently to different sorts of controversies" [quoting Meagher, Gummow and Lehane's Equity: Doctrines and Remedies, 5th ed (2015) at 626 [19-175]]. 78 Edelman and Steward JJ stated that they agreed with Kiefel CJ, Keane and Gordon JJ as to the relevant principles, albeit disagreeing as to their application in the appeal, but held that there is a fundamental divide between standing in the context of public and private rights (at [83]-[99]). Gageler and Gleeson JJ, however, rejected any public/private law divide, holding that the High Court had not followed developments in the United Kingdom introducing a substantive and procedural distinction between standing in the private law contexts and standing in public law contexts (at [67]). In their Honours' view, no such bright line distinction could ever be drawn (ibid). Rather, after discussing the language used in the cases to express the interest required to establish standing to seek a declaration or injunction (at [62]-[64]), Gageler and Gleeson JJ held that: 65. Though the expression of standing has been variously in terms of a "sufficient interest", a "sufficient material interest", a "special interest" or a "real interest", the conception of standing developed through that body of case law has been consistent. That conception of standing has involved recognition that a person who does not claim to have a legal right or equitable interest to be vindicated by a declaration or other order that would resolve a controversy about a right or obligation may yet have a material interest in seeking the order. In this context, an interest will be "material" if the person "is likely to gain some advantage, other than the satisfaction of righting a wrong, upholding a principle or winning a contest, if [the order is made] or to suffer some disadvantage, other than a sense of grievance or a debt for costs, if [the order is not made]" [quoting ACF at 530]. Depending on the totality of the circumstances, the material interest that the person has in seeking the order may be sufficient to justify a court entertaining the proceeding in which the order is sought. 66. In Robinson [(1977) 138 CLR 283 at 327-328], Mason J observed that "the cases are infinitely various" and that "what is a sufficient interest in one case may be less than sufficient in another". In Onus [(1981) 149 CLR 27 at 75, quoting Baker v Carr (1962) 369 US 186 at 204], Brennan J added to that observation that the sufficiency of the interest of a person in a particular case "must be a question of degree, but not a question of discretion" and that in answering that question of degree it is appropriate to consider both whether the interest is "sufficient to assure that 'concrete adverseness which sharpens the presentation of issues' falling for determination" and whether the interest is "so distinctive" as to avoid a multiplicity of proceedings. (Emphasis added.) 79 Notwithstanding these differences in approach, neither party (correctly in my view) suggested that any doubt had been cast in Hobart International or otherwise by the High Court on the principles enunciated in decisions such as ACF, where the Court found that standing had not been established, and Onus, where standing was upheld. 80 The decision in ACF is important as particular reliance was placed upon it by the Secretary, who submitted that AVN's case was analogous to, but weaker than, the Australian Conservation Foundation's (ACF) case for standing. The ACF was a well-known environmental organisation whose objects were directed to promoting conservation of the environment in Australia. In furtherance of those objects, it sought to influence policy on environmental matters and made submissions to government and public authorities, including comments made pursuant to provisions of the (then) Environment Protection (Impact of Proposals) Act 1974 (Cth) (EPIP Act). The ACF had a national membership of about 6,500 members and received annual grants from the Commonwealth (ACF at 519 (Gibbs J)). The ACF sought declarations, injunctions and other orders against the Commonwealth and others challenging the validity of a decision to approve a proposal by a private company, Iwasaki Sangyo Company (Australia) Pty Ltd (Iwasaki), to establish and operate a resort and tourist area at Farnborough in central Queensland (the proposal) or, alternatively, to approve exchange control transactions in relation to the proposal. The ACF also delivered written comments on the proposal to the Minister and by notice in writing, had required the Minister to inform it as to what action had been taken or was proposed for ensuring consideration of the environmental aspects of the proposal (ACF at 520). The ACF alleged that there had been a failure to comply with the EPIP Act and the Administrative Procedures approved under that Act, and sought declarations (among other things) that the primary decision was invalid, as well as injunctions to prevent the respondents from (among other things) acting on the decision or purporting to authorise others to act upon or implement the decision (ibid). 81 A majority of the High Court (Gibbs, Stephen and Mason JJ; Murphy J dissenting) held that the ACF had no standing to maintain the action on the ground that in cases which do not concern constitutional validity of an enactment, a person who has no special interest in the subject matter of an action over and above that enjoyed by the public generally has no standing to sue for an injunction or declaration to prevent the violation of a public right or to enforce the performance of a public duty: ACF at 526 (Gibbs J), 538-539 (Stephen J), and 547 (Mason J (agreeing with Gibbs J)). 82 In so holding, Gibbs J explained that the ACF "seeks to enforce the public law as a matter of principle, as part of an endeavour to achieve its objects and to uphold the values which it was formed to promote" (at 526). In finding that that interest was not a special interest, Gibbs J held at 530-531: I would not deny that a person might have a special interest in the preservation of a particular environment. However, an interest, for present purposes, does not mean a mere intellectual or emotional concern. A person is not interested within the meaning of the rule, unless he is likely to gain some advantage, other than the satisfaction of righting a wrong, upholding a principle or winning a contest, if his action succeeds or to suffer some disadvantage, other than a sense of grievance or a debt for costs, if his action fails. A belief, however strongly felt, that the law generally, or a particular law, should be observed, or that conduct of a particular kind should be prevented, does not suffice to give its possessor locus standi. If that were not so, the rule requiring special interest would be meaningless. Any plaintiff who felt strongly enough to bring an action could maintain it. (Emphasis added. See also Mason J in ACF at 547-548.) 83 Gibbs J then held with respect to the ACF at 531 that: It is quite clear that when the rule is thus understood, [the ACF] has no special interest in the preservation of the environment at Farnborough, and of course none in Iwasaki's exchange control transactions. Counsel for [the ACF] sought to show an interest in two alternative ways - first, because of the nature of [the ACF] and its objects and, secondly, because of the fact that it had sent written comments when the draft environmental impact statement was made available for public comment. The fact that [the ACF] is incorporated with particular objects does not strengthen its claim to standing. A natural person does not acquire standing simply by reason of the fact that he holds certain beliefs and wishes to translate them into action, and a body corporate formed to advance the same beliefs is in no stronger position. If it is the fact that some members of [the ACF] have a special interest - and it is most unlikely that any would have a special interest to challenge the exchange control transaction - it would not follow that [the ACF] has locus standi, for a corporation does not acquire standing because some of its members possess it … The fact that [the ACF] had sent written comments which Iwasaki was required to take into account in revising its draft environmental impact statement did not give [the ACF] standing to bring the present action. A person who is concerned enough about proposed action to furnish his comments on it does not necessarily have any interest in the proposed action in the relevant sense. The fact that [the ACF] sent the written comments, as permitted by the administrative procedures, is logically irrelevant to the question whether it has a special interest giving it standing. That fact would only have some significance in relation to this question if the administrative procedures revealed an intention that a person who sent written comments thereby acquired further rights. As I have endeavoured to show, that is not the case. [Citations omitted.] 84 Similarly, Stephen J held at 538-539: Only two aspects of [the ACF's] circumstances in any way relate to what might be thought to answer the description of "special damage peculiar to himself". First is the concern which the appellant has for Australia's environment and what it regards as the particular threat to its preservation represented by the Farnborough development: the question being whether such a concern, coupled with such a perceived threat, can be treated as involving damage to the appellant or at least apprehension of such damage. Secondly, the appellant's role as commentator upon the draft EIS, coupled with what is seen as a failure to give proper consideration to those comments, might also be argued as involving an element of special damage peculiar to the appellant. As to the first of these aspects, there is no support to be found in existing Australian or English law for regarding it as giving standing to sue. An individual does not suffer such damage as gives rise to standing to sue merely because it voices a particular concern in regards to the actions of another as injurious to the object of that concern. That it is a body corporate rather than an individual which seeks to do so cannot of itself alter that position; the fact that that body corporate has as its main object the voicing, and encouragement in the community, of just such a concern no doubt ensures that what it does to give effect to such an object will not be ultra vires; it will not otherwise improve its position. 85 By contrast, in Onus, the High Court held that persons who claimed to be descendants and members of the Gournditchjmara Aboriginal People and custodians of relics of cultural and spiritual importance to them under their laws and customs, had standing to seek relief restraining the respondent from contravening a statutory proscription against damaging or interfering with a relic under the Archaeological and Aboriginal Relics Preservation Act 1972 (Vic) (the Relics Act), which would be an offence. In explaining the principles as to standing, Gibbs CJ in Onus at 35-36 held that: The case is therefore one in which two private citizens who cannot show that any right of their own has been infringed bring an action for the purpose of restraining another private citizen (Alcoa) from breaking the criminal law and by acting in contravention of s. 21 of the Relics Act. The question is whether they have standing to bring the action. If an attempt were made to frame an ideal law governing the standing of a private person to sue for such a purpose, it would be necessary to give weight to conflicting considerations. On the one hand it may be thought that in a community which professes to live by the rule of law the court should be open to anyone who genuinely seeks to prevent the law from being ignored or violated. On the other hand, if standing is accorded to any citizen to sue to prevent breaches of the law by another, there exists the possibility, not only that the processes of the law will be abused by busybodies and cranks and persons actuated by malice, but also that persons or groups who feel strongly enough about an issue will be prepared to put some other citizen, with whom they have had no relationship, and whose actions have not affected them except by causing them intellectual or emotional concern, to very great cost and inconvenience in defending the legality of his [or her] actions. Moreover, ideal rules as to standing would not fail to take account of the fact that it is desirable, in an adversary [sic] system, that the courts should decide only a real controversy between parties each of whom has a direct stake in the outcome of the proceedings. The principle which has been settled by the courts does attempt a reconciliation between these considerations. That principle was recently stated in Australian Conservation Foundation Inc v The Commonwealth. A plaintiff has no standing to bring an action to prevent the violation of a public right if he has no interest in the subject matter beyond that of any other member of the public; if no private right of [her or] his is interfered with [she or] he has standing to sue only if [she or] he has a special interest in the subject matter of the action. The rule is obviously a flexible one since, as was pointed out in that case, the question what is a sufficient interest will vary according to the nature of the subject matter of the litigation. (Emphasis added; footnotes omitted.)

5.2 Matters relied on by AVN in support of its case for standing 86 AVN relied upon a number of factors in support of its contention that it has a special interest in enforcing the public rights the subject of both its mandamus case and its judicial review case and therefore that it has standing to seek that relief. Those factors relied upon were as follows. (1) The objectives of AVN (set out earlier above at [26]) are "consistent with the objectives of the TG Act in that both sets of objectives are concerned with among other things the safety and efficacy of the [Three] Vaccines used in Australia" (AS at [39]; AR at [3]). (2) Since its incorporation, AVN has lobbied governments across Australia in respect of the safety and efficacy of vaccines, especially insofar as vaccines affect children, and has contributed to public debate by providing information concerning vaccines (AS at [37]; AR at [5]-[6]); (3) AVN is recognised as the peak national association in Australia concerning the safety and efficacy of vaccines and the Australian community expects that there will be a body such as AVN to concern itself with the issues raised by the present proceeding (AS at [47]; AR at [9]). (4) AVN has made submissions to the Secretary and the Minister regarding the Three Vaccines and the Children's Decision by way of letters which include hyperlinks to the sources AVN relied upon in support of its concerns (AR at [8]). (5) AVN has provided the Secretary "with plain and repeated warnings" that, absent a satisfactory response, it would commence litigation (AS at [44]; AR at [8]). (6) Governments have adopted mandatory vaccination policies for certain sectors and the issues, by their nature and significance to the public, should be amendable to scrutiny by the courts and independent experts (AS at [46]). (7) AVN has suffered "psychological and emotional harm and injury" due to, or in connection with, the Three Vaccines, including adverse effects suffered by the children of some of its members (AS at [45]). (8) AVN conducts its activities with a genuine desire to protect its members and all Australians, including Australian children, as reflected in the personal experiences of Ms Dorey and some of its members (AS at [47]; AR at [4]). (9) AVN considers it would be inadequate to rely on the Attorney-General to act as a relator on behalf of the Commonwealth in this proceeding on the view that she is "not an apolitical guardian of the public interest" (AS at [48]). (10) AVN is "seeking to pursue remedies in the public interest and it holds a genuine desire and need to test the validity of the decisions affecting its area of specific community activity" (AS at [49]). (See also AS at [52]-[53] and AR at [7].)

5.3 AVN lacks standing 87 Neither individually nor cumulatively do the factors relied upon by AVN establish a special interest over and above that held by an ordinary member of the public. In this regard, while fully accepting that each case must be considered on its own facts and that questions of standing turn on matters of fact and degree, I agree with the Secretary that AVN's case for standing is analogous in many respects to the case by the ACF for standing, albeit weaker. 88 First and centrally to its claim, AVN submits that it has standing: because it holds a special interest in enforcing the public right which is the subject of the mandamus case; namely, calling (in its capacity as the peak vaccines organisation in Australia) on the respondent "to cause to be maintained" the [Register] by exercising his powers according to law as to whether to suspend or cancel the provisional registration of the Vaccines on the [Register]. (AS at [35]; emphasis added.) 89 However, the evidence rises no higher than to establish that it is Ms Dorey's view that AVN is the peak vaccines organisation in Australia. There is no evidence, for example, that AVN is regarded as such by government, whether acknowledged in funding from government sources or otherwise: Right to Life Association (NSW) Inc v Secretary, Department of Human Services and Health [1995] FCA 33; (1995) 56 FCR 50 (Right to Life) at 67 (Lockhart J). Nor is there any evidence that AVN is regarded as a peak body by recognised or established peak organisations or in the public eye. Moreover, there is no evidence that AVN is a body representing the views of persons recognised as experts in the field of immunology and vaccines. To the contrary, membership is open to any natural person who supports AVN's objectives and whose application has been approved by the committee (see above at [24]). Further, the evidence that the Australian community expects that there will be a body such as AVN to concern itself with issues such as those raised in the present case does not rise above the status of bare assertion by Ms Dorey. 90 Secondly, as is apparent from ACF, the fact that AVN seeks relief in furtherance of its objects does not suffice to establish standing, just as an individual does not gain standing to sue merely by voicing a concern no matter how strongly felt. Similarly, Lockhart J explained in Right to Life at 67 (on appeal from the decision of Lindgren J): If an individual sought to acquire standing by virtue of its strong feelings and emotional concern with the decision made and had no other connection with the subject matter of the decision, that individual has no standing. A corporation cannot be placed in any better position than the individual and this applies even in the case where the corporation has included in its members those who would themselves have an interest in the subject matter of the litigation: Victorian Chamber of Manufactures v Commonwealth (1943) 67 CLR 335 at 347 and 413. As Lindgren J pointed out correctly in my view: "It would allow individuals who were opposed to a decision, albeit sincerely and for unselfish motives, to acquire standing to challenge it by the procedure of devising an appropriate form of constitution, and if necessary procuring corporate form." 91 Further and in any event, it will be recalled that AVN's objects were concerned with the dissemination of information about vaccine safety, with promoting choice and alternative views, and, in line with its correspondence to the Minister and others which is earlier summarised, with representing concerns on behalf of its members about vaccination to government and other bodies. As such, AVN's objects are not concerned with enforcing the TG Act. Nor does the TG Act address or seek to resolve the complex social issues associated with mandating vaccines. Registration of a vaccine under the TG Act does not mandate its administration and thereby deprive individuals of a choice as to whether or not to take the vaccine. The fact that particular governments or employers might require that individuals be vaccinated against COVID-19 in certain areas of employment or circumstances is not a legal consequence flowing from registration of the Three Vaccines under the TG Act, but is the result of separate decisions or conditions that may be imposed by various governments and employers, such as in the form of vaccination requirements under legislative enactments or workplace policies (see also below at [143]). 92 Nor does registration under the TG Act prevent the dissemination of information about the Three Vaccines, or vaccines generally, or impact upon the capacity of AVN to make representations about them as provided for in its objects. In short, and adapting the words of Lockhart J in Right to Life at 67-68, the fact that a body such as AVN may, in the exercise of free speech, seek to influence public opinion and government views in pursuit of its objects, does not translate into a right of standing to pursue proceedings in a court of law. 93 AVN also submitted that its objectives are "consistent with the objectives of the TG Act" and sought to rely upon this in support of its case for standing (AS at [39]; see also AS at [52] in relation to the submissions on jurisdiction under the ADJR Act). Broadly speaking, it can be inferred that AVN's concerns are with the safety and efficacy of vaccines in the public interest, as AVN submits. However, that does not mean that there is a true alignment with the objects of the TG Act. To the contrary, the TG Act is concerned with establishing a national system of controls based upon the quality, safety, efficacy, and timely availability of therapeutic goods, central to which is the conduct by experts in the field of the necessary investigations, testing and evaluation, and the making of skilled judgments as to the suitability or otherwise of a drug: see s 4(1)(a) of the TG Act, regs 39F and 39G of the Regulations; see also Alphapharm at 261 (Davies J). 94 Thirdly, the fact that AVN has lobbied governments and made submissions to State and Commonwealth parliamentary committees and other government bodies on vaccine safety and efficacy, including with respect to the Three Vaccines and vaccination of children, and that it has made available information to the public concerning vaccines, does not without more strengthen its claim to standing: ACF at 531 (Gibbs J) and 538-359 (Stephen J); United States Tobacco Co v Minister for Consumer Affairs [1988] FCA 561; (1988) 20 FCR 520 (US Tobacco) at 530 (the Court); North Coast Environment Council Inc v Minister for Resources (No 2) [1994] FCA 989; (1994) 55 FCR 492 (North Coast) at 512 (Sackville J). Nor does the fact that AVN wrote to the Secretary on 26 November 2021 and 16 December 2021 demanding that he exercise his discretionary powers under ss 29D or 30 of the TG Act to suspend or cancel the provisional registration of the Three Vaccines, and threatening to commence litigation, advance AVN's position vis a vis standing to seek relief in this case: ibid. 95 In the fourth place, AVN submitted that (through Ms Dorey and its other members) it had a special interest by reason of having suffered psychological and emotional harm and injury due to, or in connection with, the Three Vaccines and/or other vaccines, including by reason of the children of some of its members having suffered adverse effects from vaccines. I accept that Ms Dorey's views and beliefs to this effect are genuinely held and infer that they may represent the views and beliefs of other members of AVN. I also accept that Ms Dorey is emotionally impacted upon by the harm which she believes was caused to her son and to others from vaccines administered to them. However, no expert or other evidence was led which supported Ms Dorey's evidence that she and other members of AVN have suffered psychological or emotional harm or injury, as expressed in her January affidavit at [8]-[21]. Furthermore, her views to this effect were inadmissible opinion evidence and hearsay, and therefore admitted subject to the s 136 Limitation (see above at [13]). As such, that evidence can be given no weight beyond establishing Ms Dorey's personal beliefs. It follows that the applicants have not established an evidential basis for Ms Dorey's opinion that injury or harm of the kind alleged was caused to Ms Dorey or other members of AVN or their children by any vaccines or by the provisional registration of the Three Vaccines. Furthermore, even if such injury or harm to individual members could have sufficed to establish that they had standing, that would not mean that AVN acquired standing. Rather, as Gibbs J said in a passage earlier quoted from ACF, "a corporation does not acquire standing because some of its members possess it …" (see above at [83]). 96 Fifthly, many of the indicia of standing in respect of third parties such as AVN are absent from the scheme established by the TG Act. As the Secretary submitted in the respondent's written submissions (RS): Absent are many rights suggestive of standing to sue - at least by the AVN and Mr Neugebauer - in respect of a decision to provisionally register therapeutic goods: there is no requirement that applications for registration be advertised; no provision for the hearing of witnesses or any interested parties upon an application for registration; no requirement that a decision under s 25(3) to register goods be published generally; the procedure of investigation, testing and evaluation is undertaken by experts in the field and is confidential; and reasons are required only where the decision is not to register therapeutic goods. (RS at [21]; emphasis added; footnotes omitted.) 97 Indeed, in ACF not even the fact that the ACF sent written submissions which Iwasaki, as the proponent of the proposal under assessment, was required under the EPIP Act to take into account in revising its draft environmental impact statement, was held to give the ACF standing to challenge the validity of the decision approving the proposal. In short, this is not a case where weight can be given to the person's interest as one which falls "within the scope of interests sought to be protected or advanced by the exercise of a statutory power or executive authority through which the right or obligation in controversy has come into existence": Hobart International at [69] (Gageler and Gleeson JJ). 98 In the sixth place, traditionally it has been the responsibility of the Attorney-General to assert public rights and prevent public wrongs either proceeding ex officio or on the relation of a private individual (ACF at 526 (Gibbs J)). While AVN submits that it should have standing to litigate the issues in the present case on the basis that the Attorney-General is "not an apolitical guardian of the public interest", the difficulty with that submission is that it is an appeal to the exercise of a discretion which the Court does not have in determining questions of standing and matter. It does not overcome the fundamental difficulty that AVN has been unable to demonstrate an interest greater than that of an ordinary member of the public. As such, that submission does not advance AVN's case for standing. 99 Ultimately, these matters demonstrate that AVN's interest in the subject matter of the proceedings is to "right" what it regards as a "wrong". As the Secretary contended, so much is confirmed by AVN's submission that its purpose in pursuing the Mandamus Case is its desire "to test the validity of the decisions" and its interest that the law be observed (see AS at [49]; AR at [4]). However, as the authorities to which I have referred make clear, it is not sufficient that a person, if successful, will gain only "the satisfaction of righting a wrong, upholding a principle or winning a contest" or, if it loses, a sense of grievance, no matter how strongly felt, or an adverse order for costs (ACF at 530). If AVN's submissions as to its interest were correct, any member of the public having the same concerns would have standing. As such, AVN's grievance with the decision the subject matter of the Mandamus Case does not extend beyond that of an ordinary member of the public in a relevant sense.

IS AVN A "PERSON AGGRIEVED" FOR THE PURPOSES OF SECTIONS 5 AND 7 OF THE ADJR ACT?

6.1 "Person aggrieved" for the purposes of the ADJR Act: relevant principles 100 Section 5(1) of the ADJR Act relevantly provides that "[a] person who is aggrieved by a decision to which this Act applies" (person aggrieved) may apply to the Federal Court for an order of review in respect of the decision on any of the grounds described under that subsection. Those grounds include, for example, that procedures required to be observed in connection with the making of the decision were not observed, and that the decision-maker lacked jurisdiction to make the decision, failed to take a relevant consideration into account, took an irrelevant consideration into account, or otherwise made an error of law. 101 Section 7(1) of the ADJR Act addresses circumstances where the complaint is that a decision has not been made and relevantly provides that: Where: a) a person has a duty to make a decision to which this Act applies; b) there is no law that prescribes a period within which the person is required to make that decision; and c) the person has failed to make that decision; a person who is aggrieved by the failure of the first-mentioned person to make the decision may apply to the Federal Court … for an order of review in respect of the failure to make the decision on the ground that there has been unreasonable delay in making the decision. 102 Central to both provisions is, therefore, the concept that the person must be "aggrieved" by the decision or the failure to make a decision as the case may be. Section 3(4)(a) of the ADJR Act provides that a reference to a person aggrieved by a decision includes a reference to "a person whose interests are adversely affected by the decision". In turn, under section 3(4)(b), a reference to a person aggrieved by a failure to make a decision "includes a reference to a person whose interests are or would be adversely affected by the conduct or failure". 103 First, as Lockhart J observed in Right to Life at 65, "the term a 'person aggrieved' is not a restrictive one; it is of very wide import". As such, the authorities have cautioned against grafting restrictions onto the general language used, such as requiring that the interest be "direct" or "immediate": e.g. Argos Pty Ltd v Minster for the Environment and Sustainable Development [2014] HCA 50; (2014) 254 CLR 394 (Argos) at [48] (French CJ and Keane J) and [60] (Hayne and Bell JJ). Equally, in Argos, French CJ and Keane J observed that the text of ss 3B(1)(a) and 5(1) of the Administrative Decisions (Judicial Review) Act 1989 (ACT) (ADJR Act (ACT)) (which, as their Honours observed at [27], mirrors ss 3(4)(a)(i) and 5(1) the ADJR Act ): 42. … does not allow for expansion or contraction according to the scope and purpose of the enactment under which the decision is made. It is not to be read or applied with reference to normative considerations based on the policy of the enactment. To do so by reference to individual enactments would undermine an important purpose of the [ADJR Act (ACT)], which was to simplify judicial review processes. (See also ibid at [45].) 104 This approach accords with that adopted with respect to standing, as explained by Gageler and Gleeson JJ in Hobart International as follows: 56. … we conceive of standing to seek an order from a court as an aspect of the positive law that defines the jurisdiction of the court to hear and determine the proceeding in which the order is sought. What, if anything, a person must establish to have a right to seek a particular order from a particular court in the exercise of a jurisdiction vested in it by a Commonwealth law depends on what, if anything, the Commonwealth law vesting that jurisdiction in that court expressly or implicitly requires to be established. [Footnote omitted.] 105 Secondly, Hayne and Bell JJ in Argos explained that: 61. The focus of the inquiry required by the words is upon the connection between the decision and interests of the person who claims to be aggrieved. The interests that may be adversely affected by a decision may take any of a variety of forms. They include, but are not confined to, legal rights, privileges, permissions or interests. And the central notion conveyed by the words is that the person claiming to be aggrieved can show that the decision will have an effect on his or her interests which is different from … its effect on the public at large … 62. It is inevitable that there will be cases where deciding whether a person's interests are adversely affected by decision will require judgements of fact and degree. [Footnotes omitted.] 106 Thus, in common with the principles governing standing, the concept of a person aggrieved by a decision or inaction does not extend to any member of the public, but at least includes "a person who can show a grievance which will be suffered as a result of the decision complained of beyond that which he or she has as an ordinary member of the public": Tooheys Ltd v Minister for Business and Consumer (1981) 4 ALD 277 at 290; 36 ALR 64 at 79 per Ellicott J (cited with approval in, e.g., Argos at [28] (French CJ and Keane J) and [61] (Hayne and Bell JJ); US Tobacco at 527 (Davies, Wilcox and Gummow JJ); Right to Life at 65 (Lockhart J). 107 Further, while a grievance in the relevant sense may be established because the decision directly affects the individual's existing or future legal rights, a less direct effect such as a practical impact upon a person's business may also suffice in some cases: Tooheys at 290; Argos at [28]-[32] (French CJ and Keane J) and [62] (Hayne and Bell JJ); Bateman's Bay Local Aboriginal Land Council v The Aboriginal Community Benefit Fund Pty Ltd [1998] HCA 49; (1998) 194 CLR 247 (Bateman's Bay) at [49] and [52] (Gaudron, Gummow and Kirby JJ). 108 It follows that the question of whether a person's interests are affected such that they are a person aggrieved for the purposes of the ADJR Act can turn upon matters of fact and degree, as is the case with questions of standing. Thus the Full Court explained in US Tobacco that (at 529): The nature of the interest required in a particular case will be influenced by the subject matter and context of the decision under review. As Brennan J said in [Re McHattan and Collector of Customs (1977) 18 ALR 154] at 157: 'However, a decision which affects interests of one person directly may affect the interests of others indirectly. Across the pool of sundry interest, the ripples of affection may widely extend. The problem which is inherent in the language of the statute is the determination of the point beyond which the affection of interests by a decision should be regarded as too remote … The character of the decision is relevant, for if the interests relied on are of such a kind that a decision of the given character could not affect them directly, there must be some evidence to show that the interests are in truth affected.' 109 Thirdly, it has been observed that the test, therefore, for a person aggrieved under the ADJR Act is "in substance indistinguishable from the High Court's special interest test": Aronson et al, Judicial Review of Administrative Action and Government Liability (7th ed, Lawbook, 2022) at [14.290]. Thus for example, in North Coast, in holding that the applicant was a person aggrieved by the respondent's grant of an export licence, Sackville J observed at 511-512 that "it has never been held that the principles governing the award of declarations and injunctions under the general law have been superseded by different and broader conceptions under the ADJR Act". Wheeler J came to a similar view in Bridgetown/Greenbushes Friends of the Forest Inc v Department of Conservation and Land Management (1997) 18 WAR 102 at 110. Templeman J (with whose reasons Scott JJ agreed at 150) approved her Honour's approach on appeal in Bridgetown/Greenbushes Friends of the Forest Inc v Executive Director of the Department of Conservation and Land Management (1997) 18 WAR 126 (Bridgetown (Full Court)) at 160. 110 In any event, in this case AVN (and Mr Neugebauer) did not contend that any different test applied in establishing that their interests were affected such that they were persons aggrieved under the ADJR Act (AS at [51]).

6.2 AVN is not a "person aggrieved" 111 In support of its contention that it was a "person aggrieved" for the purposes of ss 5 and 7 of the ADJR Act, AVN relied upon the same factors as those said to establish that it had standing to seek relief. It therefore follows that, as AVN cannot establish a grievance which will be suffered beyond that of an ordinary member of the public for the reasons earlier given, it is not a "person aggrieved" for the purpose of these provisions.

7.1 Mr Neugebauer's contentions in support of the application for joinder in the Mandamus Case 112 Mr Neugebauer is a former disability support worker and is not a member of AVN. The applicants contend, first, that Mr Neugebauer's interests are adversely affected by the Secretary's failure to consider suspending or cancelling the Three Vaccines and therefore he has standing to pursue the mandamus case, even if (as I have held) AVN does not. As such, the applicants submit that his application for joinder as an applicant should be granted. 113 Mr Neugebauer worked in the disability support industry in South Australia for six years, initially in the government sector and, for the past three years, as a team leader and then a disability support worker in a private organisation, Community Living Australia (CLA), until his employment was terminated on 7 December 2021 in circumstances I explain below. 114 On 8 November 2021, the State Co-ordinator for South Australia signed the Emergency Management (In-home and Community Aged Care and Disability Support Workers Vaccination) (COVID-19) Direction 2021 (the SA Direction) under s 25 of the Emergency Management Act 2004 (SA). Clause 2 of the SA Direction states that the purpose of this direction is to: (a) reduce the risk of transmission of COVID-19 to vulnerable members of the community by persons providing them in-home or community-based care; (b) maintain the provision of in-home and community aged care and disability support services despite the presence of COVID-19 in the community; (c) minimise the disruption to those services due to the spread of COVID-19 amongst in-home and community aged care and disability support service workers; and (d) minimise a direct disruption to those services due to in-home community aged care and disability support service workers being furloughed following possible exposure to COVID-19. (Annexure MN-07, Second Neugebauer affidavit.) 115 Clause 4(1) of the SA Direction provides that: A person must not engage in work or perform duties of an in-home and community aged care worker or a disability support worker from 30 November 2021 unless⸺ (a) the person has received at least one dose of a TGA approved or recognised COVID-19 vaccine; and (b) the person has received, or has evidence of a booking to receive, a second dose of a TGA approved or recognised COVID-19 vaccine within the interval after the first dose recommended by the ATAGI for that COVID-19 vaccine. 116 The vaccination requirement imposed by cl 4(1) was subject to medical exemptions in the circumstances specified in clause 4(3) of the SA Direction. There is no suggestion that Mr Neugebauer met the requirements of a medical exemption specified in that clause. 117 Clause 4(2) of the SA Direction provides that a person subject to the requirement in clause 4(1) "must provide the responsible provider with evidence of their vaccination status upon request." 118 Furthermore, clause 4(4) provides that: A responsible provider must⸺ (a) not permit a person to engage in work or perform duties of an in-home and community aged care worker or a disability support worker for on behalf of the responsible provider unless the person complies with the vaccination requirements in clause 4(1) or is exempt from those requirements under this direction or by an authorised officer; and (b) keep records of the vaccination status of any person engaged to work or perform duties of an in-home and community aged care worker or disability support worker; and (c) for the purpose of subclause (4)(b) verify the vaccination status of a person engaged in work or perform duties of an in-home and community aged care worker or a disability support worker by sighting evidence of the vaccination. 119 Failure to comply with the SA Direction was an offence. 120 It was not in issue that CLA was a "responsible provider" as defined in cl 3(1) of the SA Direction. 121 On 11 November 2021, CLA sent an email to Mr Neugebauer advising that: From 30 November 2021, any person who has not provided the required evidence of vaccination or exemption will not be eligible to engage in work or perform duties of a disability support worker for Community Living Australia. 122 On 26 November 2021, CLA wrote advising that Mr Neugebauer's employment may be terminated if it could not lawfully permit him to perform any work in view of his indication that he did not intend to receive the vaccination, did not have a medical exemption, and his acknowledgement that from 30 November 2021 he would be ineligible to perform work for CLA. Mr Neugebauer's employment as a disability support worker was terminated shortly thereafter on 7 December 2021 in view of his advice that he had not been vaccinated and that he had not provided a medical exemption as required by the SA Direction. 123 Mr Neugebauer explained that he had refused to be vaccinated due to his concerns about the risks which he believed were associated with the Three Vaccines and his belief that the risks posed by unvaccinated people working in the disability sector were "negligible" (First Neugebauer affidavit at [2(c)] and [2(h)]. He gave evidence of his belief that if the provisional approvals for the Three Vaccines had been suspended or cancelled by the Secretary, he would not currently be unemployed and would be working in the job and in the field he had grown to love (First Neugebauer affidavit at [2(i)].

7.2 Mr Neugebauer lacks standing to seek relief in the Mandamus Case and is not a "person aggrieved" 124 A person seeking joinder as an applicant under the ADJR Act must be able to identify a relevant interest: US Tobacco at 529 (the Court) (quoting with approval from Control Investments Pty Ltd v Australian Broadcasting Tribunal (No 1) (1980) 50 FLR 1 at 8-9 (Davies J)). In turn, the nature of the interest required in a particular case will be influenced by the subject matter and context of the decision under review (ibid). 125 Insofar as Mr Neugebauer seeks to be joined as an applicant, it is incumbent upon him to establish that he has a special interest particularly in circumstances where I have already found that the current applicant, AVN, lacks standing to pursue the application for relief. So much was not in issue between the parties. 126 For the reasons already given, Mr Neugebauer's reliance upon correspondence to various Members of the Parliament and the South Australian Department for Child Protection (DCP) is misplaced as it does not suffice alone to establish a special interest in the subject matter of the proceeding, either in terms of the Mandamus Case or the Judicial Review Case. 127 The applicants also submit that: Had the respondent not breached his duty imposed by s 9A(1) he would have considered the suspension or cancellation of the provisional registration of the Vaccines on the [Register]. Had that suspension or cancellation occurred, … the Order [ie. the SA Direction] would have ceased to have been effective and Mr Neugebauer would today remain employed in the disability sector … (AS at [61].) 128 As such, as the Secretary submitted, it is apparent that Mr Neugebauer's real complaint is with the termination of his employment by CLA for his failure to comply with the requirements of the SA Direction, and the advantage which he seeks to achieve if he were joined and successfully prosecuted the Mandamus Case is the reinstatement of his employment. It is on this basis that Mr Neugebauer contends that his interest rises above that of an ordinary member of the public in so far as the Mandamus Case is concerned. 129 Yet Mr Neugebauer does not seek to challenge the validity of the SA Direction or its application to him, and the relief sought in the Application would not achieve reinstatement of his employment. Even if the Secretary were to consider the exercise of his powers in ss 29D or 30 of the TG Act and, on such consideration, were to decide to suspend or cancel provisional registration of the Three Vaccines, those decisions could operate only prospectively by force of ss 29E(1) and 30(5) respectively of the TG Act. It follows (as submitted by the Secretary) that neither the suspension nor the cancellation of the provisional registration of the Three Vaccines could alter the fact that as at 7 December 2021 when his employment was terminated, the Three Vaccines were provisionally registered and Mr Neugebauer had not complied with the vaccination requirement in the SA Direction. This is therefore a case where the interest relied upon would not in truth be affected by the grant of the relief sought. Mr Neugebauer therefore lacks standing to seek that relief and is not a person aggrieved by the alleged failure by the Secretary to consider the exercise of his powers in ss 29D and 30 of the TG Act.

7.3 Mr Neugebauer's contentions in support of his joinder application in the Judicial Review Case 130 The applicants also contend that Mr Neugebauer's interests are adversely affected by the Children Decision and any s 22D Determination because he is a foster parent for a young child until the child turns 18 years of age. 131 The DCP has legal guardianship of the foster child, with a supervisor within the DCP having been appointed (the supervisor). In this regard, as the Secretary submitted (and as was not disputed by the applicants), while the order made by the Youth Court of South Australia on 24 January 2017 provided that the foster child was to be "placed under the guardianship of the Minister for Education and Child Development until [the foster child] attains 18 years of age", by force of s 24 of the Children's Protection Law Reform (Transitional Arrangements and Related Amendments) Act 2017 (SA): (1) the foster child was taken to be under the guardianship of the Chief Executive of the DCP; and (2) that placement took effect as if the foster child had been so placed by the Chief Executive under s 84 of the Children and Young People (Safety) Act 2017 (SA) (CYP Act). 132 As a result, s 82 of the CYP Act applies and provides that an approved carer in whose care a child is placed (such as Mr Neugebauer) is entitled to participate in any decision-making process relating to the health, safety, welfare or well-being of the child unless the decision-maker is satisfied that the participation of the approved carer would not be in the best interests of the child. 133 On 6 April 2017, the supervisor signed her consent for the foster child to be provided with any vaccinations required (Annexure MN-05, Second Neugebauer affidavit). 134 Mr Neugebauer said that he and his wife treat their foster child like their own biological children and that their foster child would have a home for life with their family. It was also his undisputed evidence that: i. … My wife and I make all of the day to day decisions for our foster child. We organise and attend medical appointments, organise the day to day running of all our child's needs, and organise his schooling. The Department for Child Protection (DCP) in South Australia has regular catchups with our advocacy agency who we are registered through (Anglicare). They ultimately only intervene in particular situations. A form which the Department distributes which differentiates what foster parents are generally responsible for, and what the Department is generally responsible for, titled "Who can say ok", is annexed and marked MN-1. ii. Since early 2021 when the Pfizer vaccine was provisionally approved in Australia, I have regularly corresponded with the DCP to make clear that I do not wish my foster child to receive such a vaccine, even if provisionally approved for his age group. iii. In December 2021, the Pfizer vaccine was provisionally approved for 5-11 year old children (the Children's Decision). iv. On 14 February 2022, I received an email from [Ms] O'Neill, Social Worker at the DCP, which stated that "it is the department's position that all eligible children and young people (unless medically contraindicated) should receive the Covid-19 vaccination. Accordingly, DCP requires an appointment be made for [my foster child]". v. On 15 February 2022, I responded to Ms O'Neill, noting that: 1. My wife and I do not support our foster child receiving the provisionally approved Pfizer vaccine; and 2. That as a foster parent, I am a mandated notifier at law, and that I am required by law to notify the DCP if I suspect on reasonable grounds that a child or young person is, or may be, at risk of harm, and that I believed that the DCP's intention to vaccinate my foster child puts [the child] at risk of harm. … (First Neugebauer affidavit at [2(j)].) 135 As a result, Mr Neugebauer gave evidence that his interests are affected in two specific ways: vi. I believe that due to the Children's Decision I am unable to meet my obligations as a mandated notifier. vii. I am extremely fearful for my foster child's ongoing health and wellbeing - not just currently, but in the future. There is nothing that tells us he will not be adversely affected by undergoing the Pfizer vaccination. We do not know the long term risk of these things … I have been caring for this child his whole life and it tears me apart that, because of the Children's Decision, and because the DCP is saying he is therefore "eligible" to be vaccinated, that we are being told this is compulsory. 136 It will be recalled that part of the evidence at paragraph 2(j)(vii) of the First Neugebauer affidavit was admitted subject to the s 136 Limitation and therefore, while I accept that the paragraph describes Mr Neugebauer's subjective opinions about the risks associated with the vaccination of his foster child, they cannot properly be (and are not) admitted as expert evidence establishing the truth of those opinions.

7.4 Mr Neugebauer lacks standing to pursue the Judicial Review Case and is not a "person aggrieved" 137 It is apparent that Mr Neugebauer claims to have standing in his personal capacity to seek certiorari to quash the Children's Decision and any determination by the Secretary pursuant to s 22D of the TG Act. He does not claim that he is suing on behalf of his foster child on the basis that the child's interests stand to be affected. 138 Furthermore, no submissions were made in support of and developing Mr Neugebauer's evidence that he would be unable to meet his obligations as a mandated notifier. As such, I understand that that proposition was not pressed as an interest said to give rise to standing. In any event, he did in fact notify the DCP on 15 February 2022 that he believed that the DCP's intention to vaccinate the foster child would put the child at risk. 139 The applicants' case was ultimately that the distress suffered by Mr Neugebauer "by the looming risk of his [foster child] experiencing an adverse event" (AS at [56]) if administered the Pfizer vaccine for children sufficed to establish that: (1) he had standing to seek relief to quash the Children Decision and any s 22D Determination; and (2) he is a person aggrieved for the purposes of s 5 of the ADJR Act. 140 The applicants submitted first that "[t]he Court should not deprive Mr Neugebauer of standing on the basis he is the foster, rather than biological, father" of the foster child (AS at [57]). However, the question, with respect, is not whether the Court should "deprive" Mr Neugebauer of standing because his foster child is not his biological child. The question is as to the proper application of s 5 of the ADJR Act, which the Court is bound to apply as a valid law of the Parliament. Furthermore, as earlier explained, questions of standing and whether a person is a "person aggrieved" in the statutory sense, do not turn upon any exercise of discretion. 141 Secondly, I accept that Mr Neugebauer feels strongly about the provisional approvals of the Three Vaccines and about the Children Decision insofar as it impacts upon his foster child by reason of his foster child being required by the DCP to receive the vaccine, and also upon the community more generally. The strength of his views is apparent from the Third Neugebauer affidavit and letters from him to various members of the Parliament and to the DCP. I also do not doubt the love and affection in which he holds his foster child, and his evidence that he and his wife do not differentiate between their foster child and their biological children in their affections. However, those matters alone do not suffice to determine that Mr Neugebauer's interest rises beyond an emotional one, albeit a strongly emotional interest. 142 Thirdly, it is common ground that Mr Neugebauer is not the foster child's guardian and does not have authority to withhold consent to his foster child being vaccinated against COVID-19. Indeed, that state of affairs goes to the heart of Mr Neugebauer's case that he has standing and is a person aggrieved. As I have explained, it is accepted that it is the Chief Executive of the DCP who is the legal guardian of the foster child and has the authority to make decisions regarding vaccinations on the child's behalf. 143 Ultimately, Mr Neugebauer's true complaint is not with the validity of the Children Decision granting provisional approval with respect to a COVID-19 vaccine for use among children between the ages of 5 to 11 years from 10 January 2022, or with any determination by the Secretary pursuant to s 22D of the TG Act to the effect that an indication of the proposed Pfizer vaccine was the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition for children between 5 to 11 years of age. Those decisions did not require that the Pfizer vaccine be administered to Mr Neugebauer's foster child. The requirement for the Pfizer vaccine to be administered to the foster child is imposed by reason of a decision having been made by the DCP in accordance with State law, the validity of which Mr Neugebauer does not seek to challenge. 144 In all of the circumstances, therefore, Mr Neugebauer has failed to establish that he has a sufficient interest to seek to quash the Children Decision or any s 22D Determination. His interest in seeking to be joined as an applicant is properly characterised as emotional in nature and its connection with the subject matter of the Judicial Review Case is too remote.

CONCLUSION 145 In circumstances where I have found that neither AVN nor Mr Neugebauer have standing to seek relief or are a "person aggrieved" for the purposes of the ADJR Act, I accept the Secretary's submission that it is unnecessary for me to consider his alternative submission that the TG Act provides an exhaustive measure of judicial review and that therefore the decision to provisionally register the therapeutic goods in issue in this proceeding is not amenable to judicial review by AVN or Mr Neugebauer. 146 For the reasons set out above, I made orders upholding the Secretary's notice of objection to competency, refusing the interlocutory application seeking to join Mr Neugebauer as an applicant in each of the Mandamus Case and Judicial Review Case, and dismissing the proceedings. As requested by the applicants, I also made orders affording the parties the opportunity to make submissions as to costs. I certify that the preceding one hundred and forty-six (146) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Perry.

Archaeological and Aboriginal Relics Preservation Act 1972(Vic)

Cases cited: Abebe v The Commonwealth [1999] HCA 14; (1999) 197 CLR 510 Alphapharm Pty Ltd v Smithkline Beecham (Australia) Pty Ltd [1994] FCA 161; (1994) 49 FCR 250 Argos Pty Ltd v Minster for the Environment and Sustainable Development [2014] HCA 50; (2014) 254 CLR 394 Australian Conservation Foundation Inc v Commonwealth (1980) 146 CLR 493 Australian Institute of Marine and Power Engineers v Secretary, Department of Transport (1986) 13 FCR 124 Bateman's Bay Local Aboriginal Land Council v The Aboriginal Community Benefit Fund Pty Ltd [1998] HCA 49; (1998) 194 CLR 247 Bridgetown/Greenbushes Friends of the Forest Inc v Executive Director of the Department of Conservation and Land Management (1997) 18 WAR 126 Bridgetown/Greenbushes Friends of the Forest Inc v Department of Conservation and Land Management (1997) 18 WAR 102 CGU Insurance Ltd v Blakeley [2016] HCA 2; (2016) 259 CLR 339 Hobart International Airport Pty Ltd v Clarence City Council [2022] HCA 5; (2022) 96 ALJR 234 Kioa v West (1985) 159 CLR 550 Kuczborski v Queensland [2014] HCA 46; (2014) 254 CLR 51 North Coast Environment Council Inc v Minister for Resources (No 2) [1994] FCA 989; (1994) 55 FCR 492 Onus v Alcoa of Australia Ltd (1981) 149 CLR 27 Re Judiciary and Navigation Acts (1921) 29 CLR 257 Right to Life Association (NSW) Inc v Secretary, Department of Human Services and Health [1995] FCA 33; (1995) 56 FCR 50 Robinson v Western Australian Museum (1977) 138 CLR 283 Tooheys Ltd v Minister for Business and Consumer (1981) 4 ALD 277 at 290; 36 ALR 64 United States Tobacco Co v Minister for Consumer Affairs [1988] FCA 561; (1988) 20 FCR 520

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