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

BETWEEN: AUSTRALIAN VACCINATION-RISKS NETWORK INCORPORATED Appellant

AND: SECRETARY, DEPARTMENT OF HEALTH Respondent

order made by: RARES, KATZMANN AND WIGNEY JJ DATE OF ORDER: 8 AUGUST 2022

1. The application for leave to appeal be refused.
2. The appeal be dismissed as incompetent.
3. The applicant pay the respondent's costs. Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

RARES J: 1 In early February this year, an organisation known as Australian Vaccination-Risks Network Incorporated (AVN) applied to the Court for orders requiring the Secretary of the Department of Health to consider whether to exercise his powers, or discharge his alleged duty under ss 29D, 30(1)(a) and (2)(a) of the Therapeutic Goods Act 1989 (Cth), to cancel or suspend the provisional registration of three COVID-19 vaccines, commonly known as the Pfizer, AstraZeneca and Moderna COVID-19 vaccines (the three vaccines). Alternatively, AVN sought declaratory relief to similar effect. AVN described that claim in its originating application as its "mandamus case". 2 AVN also applied for orders quashing or setting aside the decision of the Secretary under s 22D of the Therapeutic Goods Act to grant provisional approval with respect to a COVID vaccine sponsored by Pfizer Australia Pty Limited for use from 10 January 2022 in children aged five to 11 years (the children decision) and any determination made by the Secretary pursuant to s 22D of the Therapeutic Goods 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 in children between five and 11 years of age, (the s 22D determination). AVN described these aspects of the proceeding in the application as its "judicial review case". 3 The Secretary filed a notice of objection to competency below, contending that AVN had no standing to apply for any of the relief it sought either under s 39B of the Judiciary Act 1903 (Cth) or as a person aggrieved within the meaning of ss 5 or 7 of the Administrative Decisions (Judicial Review) Act 1977 (Cth) (the ADJR Act). AVN then applied for leave to join Mark Neugebauer as the second applicant in case the objection to competency were upheld (the joinder application). The Secretary contended that Mr Neugebauer had no standing either. 4 The primary judge dealt carefully and comprehensively with the standing of AVN and the joinder application as separate questions that she ordered be heard and determined before needing to proceed to any other aspect of the application below. 5 On 31 March 2022, after hearing from both parties orally and in writing, her Honour made orders dismissing the joinder application, upholding the Secretary's objection to the competency and dismissing AVN's application: Australian Vaccination-Risks Network v Secretary, Department of Health [2022] FCA 320 (the principal reasons). 6 On 20 June 2022, after receiving written submissions from the parties, her Honour ordered AVN to pay the Secretary's costs: Australian Vaccination-Risks Network v Secretary, Department of Health (No 2) [2022] FCA 706 (the costs reasons). 7 The effect of her Honour's decision that AVN did not have standing to bring the proceeding either under s 39B of the Judiciary Act or as a person aggrieved under the ADJR Act was that there was no "matter" so that the Court had no jurisdiction to hear and determine AVN's claims for relief: see, for example, Abebe v Commonwealth (1999) 197 CLR 510 at 527-528 [31]-[32], per Gleeson CJ and McHugh J, and Hobart International Airport Pty Ltd v Clarence City Council (2022) 399 ALR 214 at 227-228 [45]-[49] per Gageler and Gleeson JJ. So much is uncontroversial. 8 On 21 June 2022, AVN filed a notice of appeal challenging all three orders and raised no fewer than 21 grounds. Later, on 5 July 2022, AVN abandoned its challenge to her Honour's dismissal of the joinder application and the four grounds of appeal related to it.

Is the appeal competent? 9 The Secretary pointed out in his written submissions that the appeal was incompetent because an order dismissing a proceeding for want of jurisdiction is interlocutory where is does not "finally dispose of the rights of the parties" in the sense necessary to characterise it as a final judgment, relying on SZAJB v Minister for Immigration and Citizenship (2008) 168 FCR 410 at 418-419 [23] per French J, with whom Tracey J agreed at [114], and with whom Allsop J also agreed with additional reasons at 429 [68]. 10 In SZAJB 168 FCR at 418-419 [23], French J held that an order dismissing a proceeding for want of jurisdiction, where that finding does not flow from a determination of the merits of a matter, says nothing about the rights which the moving party seeks to vindicate. Such a decision simply means that the court lacks the authority to deal with the proceeding. In this situation, the order dismissing the proceeding is interlocutory. No appeal can be brought from an interlocutory judgment without leave under s 24(1A) of the Federal Court of Australia Act 1976 (Cth) (the Federal Court Act). 11 In its notice of appeal, AVN sought leave to appeal, if that were necessary, and supported that application in its written and oral submissions. AVN did not argue that SZAJB 168 FCR 410 was wrongly decided or did not apply to the circumstances of the present proceeding. It merely contended that to the extent required, if at all, leave to appeal should be granted if the orders it sought to impugn were interlocutory because they were akin to final orders. The Secretary did not suggest that AVN's technical failure to file an application for leave to appeal should be decisive and was content to have the matter dealt with on the basis that AVN could seek to persuade the Full Court, were it necessary, that it should have leave to appeal. The parties argued the matter fully as if it were an appeal. 12 Generally speaking, leave to appeal will not be granted unless, first, the decision in question is attended with sufficient doubt to warrant a grant of leave and, secondly, substantial injustice would result if leave to appeal were refused: Bienstein v Bienstein (2003) 195 ALR 225 at 231 [29] per McHugh, Kirby and Callinan JJ; Décor Corporation Pty Ltd v Dart Industries Inc (1991) 33 FCR 397 at 400 per Sheppard, Burchett and Heerey JJ. Nevertheless, the discretion to grant leave is not constrained by rigid rules: Seven Network Ltd v News Ltd (2005) 144 FCR 379 at 380 [5] per Branson J, with whom Allsop J and Edmonds J respectively agreed at 383 [21] and 385 [40]. 13 Ordinarily, where an order is interlocutory but, as a matter of law, has the practical effect of finally determining the rights of a party, there is a prima facie case for granting leave, as French J observed in SZAJB 168 FCR at 416 [18]. In addition, the overarching purpose of the civil practice procedure provisions, which include the rules and any requirement to seek leave to appeal, is to facilitate the just resolution of disputes according to law as quickly, inexpensively and efficiently as possible, as s 37M(1) of the Federal Court Act provides. The Court has an obligation to exercise any power conferred by those provisions in the way that best promotes the overarching purpose (s 37M(3)). It can scarcely be the best way to promote the overarching purpose to grant leave to appeal from a judgment which is not attended by sufficient doubt to warrant its reconsideration on appeal, raises no question of principle and would not give rise to substantial injustice were leave to appeal to be refused. But, as French J also said in SZAJB 168 FCR at 419 [24], generally speaking, where an application is dismissed for want of jurisdiction, leave to appeal is likely to be granted where the applicant presents a serious issue for argument that the dismissal was erroneous.

The issues raised in the notice of appeal 14 Leaving aside the four abandoned grounds, the notice of appeal alleges that the primary judge erred in the following substantive respects: (1) by limiting, under s 136 of the Evidence Act 1995 (Cth), the use to which the affidavits of the founder of AVN, Meryl Dorey, could be put (the s 136 limitation) and either not applying, or wrongly applying, the test in that section (ground 1); (2) by denying AVN procedural fairness because her Honour did not put it on notice that she was not going to accept its "unchallenged evidence" and would "criticise AVN" for not putting on "more or further and expert evidence" (ground 2) and by not attaching "the proper and lawful degree of weight" to Ms Dorey's statement that AVN was "the peak vaccine organisation in Australia" (ground 5); (3) by failing to identify and apply the correct test for standing to bring such a challenge (ground 3); (4) by finding that AVN did not have a special interest or grievance above that of an ordinary member of the public and instead, was merely voicing a concern, seeking to influence public opinion and or lobbying the government (grounds 4, 6, 9, 10, 11, 13, 14, 15 and 16) and by finding that the objects of AVN were not concerned with enforcing, or aligned with, the Therapeutic Goods Act (grounds 7, 8 and 12); and (5) by failing to exercise her discretion to make no order as to costs and in failing to consider AVN's submissions cumulatively (ground 21). 15 The notice of appeal is prolix and unfocussed. It suffers from the defects that Branson J identified in Sydneywide Distributors Pty Limited v Red Bull Australia Pty Limited (2002) 234 FCR 549 at 551 [4], namely: A ground of appeal is a basis upon which the appellant will contend that the judgment, or a part of the judgment, should be set aside or varied by the Court in the exercise of its appellate jurisdiction. Not every grievance entertained by a party, or its legal advisors, in respect of the factual findings or legal reasoning of the primary judge will constitute a ground of appeal. Findings as to subordinate or basic facts will rarely, if ever, found a ground of appeal. Even were the Full Court to be persuaded that different factual findings of this kind should have been made, this would not of itself lead to the judgment, or part of the judgment, being set aside or varied. This result would be achieved, if at all, only if the Full Court were persuaded that an ultimate fact in issue had been wrongly determined. The same applies with respect to steps in the primary judge's process of legal reasoning. Although alleged errors with respect to findings as to subordinate or basic facts, and as to steps in a process of legal reasoning leading to an ultimate conclusion of law, may be relied upon to support a ground of appeal, they do not themselves constitute a ground of appeal. (emphasis added)

Consideration - the s 136 limitation 16 AVN's first complaint was that her Honour erred in imposing the s 136 limitation on much of the evidence on which it relied to establish standing. Section 136 of the Evidence Act provides: 136 General discretion to limit use of evidence 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 The primary judge did not apply a limitation under s 136 to all of Ms Dorey's evidence, but only to certain parts to which the Secretary had objected. Her Honour limited the use of this evidence to establishing AVN's or Ms Dorey's belief or state of mind but not to prove the facts asserted. Her Honour did so, for the purposes of determining the separate question of standing, in circumstances in which AVN acquiesced in such a limitation. 18 Her Honour observed, in [18] of the principal reasons, that AVN had sought to rely on Ms Dorey's evidence, and the evidence for the joinder application which is no longer relevant, to prove that: it had lobbied governments on issues concerning vaccine safety, including pertaining to childhood vaccination, it had corresponded with the Secretary and the Minister to voice its concerns about provisional approvals for the three vaccines and the children decision, AVN and its members held particular opinions about the risks associated with the three vaccines, the administration of a COVID-19 vaccine to children and vaccines generally, and AVN considered those opinions to be supported by scientific evidence. 19 The primary judge noted, as the transcript bears out, that, at that stage of the proceeding, AVN did not seek to rely upon the material for a hearsay purpose, nor did it seek to establish the veracity of the opinions which Ms Dorey or the persons to whom she referred held. For example, her Honour said of cl 43 of AVN's constitution and some of Ms Dorey's evidence to the use of which she applied the s 136 limitation ([26]-[27] of the principal reasons): 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. 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. … (emphasis added) 20 Another example of the evidence the use of which her Honour limited was Ms Dorey's evidence in par 26 of one of her affidavits, namely: 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. … (emphasis added) 21 Her Honour admitted that evidence but made the s 136 limitation to limit its use to establish only the genuinely held beliefs of Ms Dorey and AVN about the basis on which it AVN claimed to have standing so as to be able to challenge the relevant decisions the subject of its application. As the Secretary's objections to the evidence at the hearing asserted, that evidence otherwise comprised inadmissible opinion evidence, was conclusory and or hearsay in nature, so that it should not have been allowed to be used to prove the truth of the facts asserted. 22 Her Honour ruled that 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", was admitted as evidence only of Ms Dorey's understanding or belief and not of evidence of the fact under s 136 of the Evidence Act. 23 Her Honour found, correctly, that AVN's evidence that was admitted at the hearing was not sufficient to establish that AVN, in fact, was regarded by governments or anyone else as "the peak vaccine organisation in Australia" or that it was otherwise recognised in the manner to which Ms Dorey referred. 24 As the Secretary observed, regs 39F and 39H of the Therapeutic Goods Regulations 1990 (Cth) established an advisory committee on vaccines, the membership of which the Minister had to appoint from, among others, the Australian Technical Advisory Group on Immunisation known as ATAGI, the National Immunisation Committee and the National Centre for Immunisation Research and Surveillance. Notably, AVN had no place in that part of the regulatory scheme. 25 AVN argued that her Honour's s 136 limitation of the use of its evidence was erroneous because she used it, in effect, to negate its standing. However, AVN did not suggest to her Honour that the limitations that she imposed on AVN's evidence ought not to have been imposed for the purposes of the argument on standing. 26 Ground 1 cannot be maintained. Her Honour was correct, for the reasons that she gave, to limit the evidence in the way she did. The ground is without substance and leave to appeal on this basis should be refused.

The procedural fairness ground 27 AVN argued that her Honour denied it procedural fairness on the basis that she had not identified to it during the hearing why she ultimately held it to the position that it had adopted about the s 136 limitations on the use of its evidence and the other deficiencies in Ms Dorey's evidence in support of her assertions that were not admissible to prove the matters the subject of those limitations. 28 AVN failed to identify any error in the way her Honour approached the matter. It argued that the Secretary, first, should have cross-examined Ms Dorey (and Mr Neugebauer) and, secondly, should have called witnesses to negate Ms Dorey's assertions such as her unsubstantiated assertion that AVN was the, or a, peak vaccination body. That argument ignored the reality that AVN had the onus to establish its standing. The Secretary was not obliged to cross-examine on inadequate proofs, lead evidence or give AVN an advice on evidence or other means of proving its standing. AVN's evidence in support of its standing was obviously incapable of proving the truth of the facts it asserted. It was no part of her Honour's duty to accord procedural fairness to give AVN advice about how to prove or strengthen its case or to give a running commentary to AVN about the deficiencies of its case: SZBEL v Minister for Immigration and Multicultural and Indigenous Affairs (2006) 228 CLR 152 at 166 [48] per Gleeson CJ, Kirby, Hayne, Callinan and Heydon JJ. It follows that ground 2 was hopeless.

The standing ground 29 The substantial argument which AVN mounted was that, on the evidence that the primary judge admitted with or (as it would have wished), without, the s 136 limitations, it had proven that it had standing to bring this proceeding. 30 While there are many cases dealing with what is a sufficient basis to sue, a leading authority is Australian Conservation Foundation Incorporated v The Commonwealth (1980) 146 CLR 493. Gibbs J, with whom Mason J substantially agreed in concurring reasons (at 547) and Stephen J formed the majority. Gibbs J noted (at 519) that there the plaintiff, the Foundation, had about 6,500 members drawn from around the Commonwealth, received annual grants from the Commonwealth as a contribution to its administrative expenses that formed a not insubstantial proportion of its income, and endeavoured to influence national policy on matters affecting the environment, for which purpose it had made submissions to governments and public authorities in respect of environmental matters, including under the statute the subject of the proceeding in the High Court. 31 The majority affirmed the decision of Aickin J at trial that the Foundation lacked standing to bring the proceeding, first, because nothing in the statutory scheme envisaged that a person other than those whom the statute recognised as having an interest should be able to challenge decisions made under it (at 524-525 per Gibbs J, 547 per Mason J and see at 546 per Stephen J) and, secondly, on the basis that, as Gibbs J held at 526 (and see too 547 per Mason J and at 539 per Stephen J): It is quite clear that an ordinary member of the public, who has no interest other than that which any member of the public has in upholding the law, has no standing to sue to prevent the violation of the public right, or to enforce the performance of a public duty. There is no difference, in this respect, between the making of the declaration and the grant of an injunction. The assertion of public rights and the prevention of public wrongs by means of those remedies is the responsibility of the Attorney-General who may proceed either ex officio or on the relation of a private individual. A private citizen who has no special interest is incapable of bringing proceedings for that purpose, unless of course, he is permitted by statute to do so. (emphasis added) 32 In addition, Gibbs J said (at 530) and Mason J expressly agreed (at 548) that: A belief, however strongly felt, that the law generally or a particular law, should be observed, or that the conduct of a particular kind should be prevented does not suffice to give its possessor locus standi. 33 In Alphapharm Pty Ltd v Smithkline Beecham (Australia) Pty Ltd (1994) 49 FCR 250 at 261D-G, 264D-F, 266D-E and 280G-281A, each of Davies, Burchett and Gummow JJ emphasised that s 60 of the then form of the Therapeutic Goods Act provided a right to challenge a decision only to an applicant for registration whose interests were affected by it, and not to third parties. They held that a competitor of an applicant for registration of a therapeutic good had no standing because the subject matter, scope and purpose of the Therapeutic Goods Act, as it then stood, did not support such a construction of that Act. As Burchett J said (at 264F): The other view would turn legislation, one of the express objects of which (see section 4) is to provide for the "timely availability of therapeutic goods" into legislation setting up institutional provision for delay. 34 That position is reinforced in the current version of the Act, as the Secretary's notice of contention propounds. The Act now contains s 60(2AB), which was inserted in 2018. It provides, relevantly, that, if the Secretary or a delegate makes a decision, first, under s 22D in relation to the registration of a therapeutic good under s 22C or, secondly, under s 25(3) in relation to the application for provisional registration of a medicine in accordance with ss 29D, 30(1) and (2)(a), a person is not entitled to request the Minister to reconsider the decision unless that person made the application. The Secretary decides such applications internally, without advertising, and must only give reasons if the application is refused. Thus, under the Therapeutic Goods Act, only the applicant for registration of the therapeutic good is given standing to apply for an internal review of such a decision not to register it. 35 In Bateman's Bay Local Aboriginal Land Council v The Aboriginal Community Benefit Fund Pty Ltd (1998) 194 CLR 247 at 266 [48], Gaudron, Gummow and Kirby JJ said Upon the true construction of the subject, scope and purpose, a particular statute may establish a regulatory regime which gives an exhaustive measure of judicial review at the instance of competitors or other third parties. 36 They instanced as an example Alphapharm 49 FCR 250. Gaudron, Gummow and Kirby JJ held (194 CLR at 267-268 [52]) that a person may be able to establish that he, she or it has standing to assert that a decision-maker failed to, or must, observe statutory limitations on his, her or its activity in respect of an interest that, as a matter of practical reality, is immediate, significant and peculiar to him, her or it. Their Honours held there that the person had standing to challenge the administrative decision because, in the market in which it operated, it was highly probable that, if the decision were acted on, the person's business would suffer severe detriment. 37 AVN relied on s 22F to say that the Secretary might have a duty to revoke a provisional determination under s 22D, which it had standing to enforce. However, there is nothing in the statutory scheme that gives rise to any arguable basis for AVN's submission. That is because s 22F is in Pt 3-2 of the Act in respect of which s 60(2AB) creates only the right to seek an internal review. 38 AVN also argued that her Honour erred in rejecting its claim to have standing on the basis of decisions in Bridgetown-Greenbushes Friends of the Forest Inc v Executive Director of the Department of Conservation & Land Management (1997) 18 WAR 126 and Alliance to Save Hinchinbrook Inc v Cook [2007] 1 Qd R 102. However, those cases did not formulate any new or different test as to standing that the line of authorities based on Australian Conservation Foundation 146 CLR 493 have consequently applied. Those two cases merely applied the existing test to the different facts of each of those cases. They provide no basis on which to suggest that the primary judge made any error in identifying and applying the test for standing. She did so accurately and lucidly in the principal reasons. 39 AVN also contended that it had standing to bring the proceeding based on the 10 factors below that her Honour identified in the principal reasons and then rejected, with sound reasons, as being insufficient. AVN argued that those factors supported its case whether or not one applied the s 136 limitations as to the use of that evidence. Ms Dorey's evidence sought to prove a factual basis for the 10 factors, namely: (1) AVN's objectives were consistent with the objectives of the Therapeutic Goods Act in that both sets of objectives considered, among other things, the safety and efficacy of the use of the three vaccines in Australia; (2) since its incorporation, AVN had lobbied governments across Australia in respect of safety and efficacy of vaccines, especially in relation to the effect of vaccines on children and it has contributed to the public debate by providing information concerning vaccines; (3) AVN is recognised as a peak national association in Australia concerning safety and efficacy of vaccines in Australia, and the Australian community expects that there will be a body, such as AVN, to concern itself with the issues raised by it in the proceeding below; (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 included hyperlinks to the sources AVN had relied on in support of its concerns; (5) AVN had provided the Secretary, "with plain and repeated warnings", that absent a satisfactory response it would commence litigation; (6) governments had adopted mandatory vaccination policies for certain sectors and issues, and the issues to which those policies give rise should be amenable to scrutiny by the courts and independent experts because of their nature and significance to the public; (7) members of AVN had 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; (8) AVN conducted its activities with a genuine desire to protect its members and all Australians, including children, as reflected in the personal experiences of Ms Dorey and some of its other members; (9) AVN considered it to be inadequate to rely on the Attorney-General to act as a relator on behalf of the Commonwealth in this proceeding because it took the view that the then Attorney-General, "is not an apolitical guardian of the public interest"; and (10) AVN is, "seeking to pursue remedies of the public interest and it holds genuine desire and need to test the validity of decisions effecting its area of specific community activity". 40 Because most of Ms Dorey's evidence was limited by her Honour's rulings under s 136 of the Evidence Act as evidence of her state of mind, her Honour did not give that evidence much weight. Indeed, it is difficult to see any error in her conclusion in that regard. Even if her Honour had wrongly limited the use of that evidence, which is not the case, those 10 factors could not have raised AVN's standing beyond that of an ordinary member of the public, in the sense identified in the ratio decidendi of Australian Conservation Foundation 146 CLR 493. While it may be accepted, as her Honour did, that AVN and Ms Dorey had a genuine and deeply held belief in their views, that belief did not advance AVN's position any further or give it locus standi to challenge the decisions which it sought to impugn in the proceeding below: Australian Conservation Foundation 146 CLR 493 at 530, 548. Nor did the fact that AVN was incorporated and had objects in its constitution strengthen its claim to standing for, as Gibbs J said (at 531): 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. 41 AVN did not suggest that her Honour misapprehended its case or incorrectly summarised its argument. Rather, it cavilled with her Honour's finding that it lacked standing. As happened in Australian Conservation Foundation 146 CLR 493, AVN was seeking to enforce public law remedies, to prevent or correct what it asserted was a public wrong, in respect of the duties which the Secretary had under the Therapeutic Goods Act, as a matter of principle and as part of an endeavour to achieve its objects and uphold the values which it was formed to promote: cf 146 CLR at 530. It follows that, as her Honour correctly found, AVN had no special interest, other than that of any member of the public, and, therefore, did not have standing to challenge the decisions the subject of its application below. Her Honour dealt comprehensively with, and correctly rejected, AVN's arguments. There is no error apparent in anything her Honour decided. 42 For these reasons, leave to appeal in respect of her Honour's decisions in relation to AVN's lack of standing including her evidentiary rulings and evaluations (ground 3-16) should be refused.

The costs issue 43 In the costs reasons, her Honour rejected AVN's submissions that it should not be required to pay costs despite having lost the proceeding. Her Honour gave very detailed and cogent reasons for doing so. She found that, having been wholly unsuccessful, AVN had not established any special circumstance to warrant departing from the ordinary rule as to costs. 44 AVN's assertions that her Honour erred were unsupported by any analysis. 45 Those assertions were wrong in principle, for the reasons that Kiefel CJ, Bell, Gageler, Keane and Nettle JJ explained in Northern Territory v Sangare (2019) 265 CLR 164 at 174-175 [28]-[31]. Their Honours adopted what McHugh J had said in his dissenting reasons in Oshlack v Richmond River Council (1998) 193 CLR 72 at 107 [92], namely: Nor is the status of the respondent as a public authority presently relevant. The law judges persons by their conduct not their identity. In the exercise of the costs discretion, all persons are entitled to be treated equally and in accordance with traditional principle. The fact that a successful respondent is a public authority should not make a court less inclined to award costs in its favour. Gone are the days when one could sensibly speak of a public authority having "available to them almost unlimited public funds." (Kent v Cavanagh (1973) 1 ACTR 43 at 55.) Moreover, if costs awards are not made in favour of successful respondents such as the Council, the public services which those authorities provide must be adversely affected. Every irrecoverable dollar spent on litigation is one dollar less to spend on the services that public authorities do and ought to provide. Often enough the services that will be reduced will be those that favour the politically weak - children, the unemployed, the disabled and the aged. Such results cannot be in the public interest. (emphasis added) 46 Here, AVN did not identify any conduct of the Secretary to suggest that there was any basis upon which he should be deprived of the costs of defending its litigation, which, however well-meant, ultimately failed. 47 In its written submissions, AVN argued that her Honour should not have awarded costs to the Secretary because he did not meet the Commonwealth's model litigant obligations imposed under s 55ZF of the Judiciary Act. However, that argument was hopeless because, first, it lacked any factual basis and, secondly, s 55ZG(2) and (3) provide that the Attorney-General's directions under s 55ZF are not enforceable by individuals or litigants and cannot be raised in any proceeding other than by or on behalf of the Attorney-General: Croker v Commonwealth of Australia [2011] FCAFC 25 at [19] per Siopis, Tracey and Gilmour JJ. 48 In its submissions on appeal, AVN repeated its complaint in ground 21 of its notice of appeal. It made submissions in relation to what it characterised as public interest considerations warranting a departure from the ordinary rule that costs follow the event where a party wholly fails. As I have explained that argument was unmaintainable because of Sangare 265 CLR 164. There was no misconduct by the Secretary in the course of the proceeding. 49 Her Honour correctly identified that her primary reasons had involved the application of well-established principles as standing in the context of the Therapeutic Goods Act and raised issues of statutory construction. The proceeding did not raise any novel question of law or matter of high importance. Nor could the proceeding be regarded as a test case and, even if it could be so characterised, that of itself would not be sufficient. That is because, as the primary judge found, correctly, the proceeding was incompetent. 50 Therefore, the Court never reached the point of considering whether the Secretary departed from administering the requirements of the Therapeutic Goods Act according to law, because AVN had failed to establish a case that it had standing to attack his decisions. The primary judge's reasoning was correct and no basis for granting leave to appeal has been established. For those reasons, no issue of principle has emerged in the challenge for which AVN seeks leave to appeal.

Conclusion 51 Her Honour's decision to dismiss AVN's application for want of jurisdiction was interlocutory because it did not determine any final rights. Her Honour merely determined that AVN had not established that it had any standing to challenge any of the decisions under the Therapeutic Goods Act that it wished to impugn. 52 For the above reasons, the appeal is incompetent and leave to appeal should be refused. No substantial injustice be suffered by a refusal for leave given AVN's lack of standing and the lack of merit of its arguments. There is no reason why AVN should not be ordered to pay the Secretary's costs of the application for leave to appeal. I certify that the preceding fifty-two (52) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Rares.

REASONS FOR JUDGMENT (Revised from the transcript) KATZMANN J: 53 I agree. I would only add that, in relation to the challenge to the cost judgment, AVN's submissions on the appeal merely repeated the complaint in ground 21 of its notice of appeal, and referred to the submissions made below. In reply it adhered to what it put in chief and failed to engage with the Secretary's submissions, to say the least. That was unsatisfactory. As the Secretary submitted, the primary judge's decision was an exercise of a broad discretion. The principles in House v The King (1936) 55 CLR 499 at 505 apply. That is to say in order to disturb the primary judge's order, AVN would have to show that her Honour acted upon a wrong principle, took into account extraneous or irrelevant matters, mistook the facts, failed to take into account a material consideration, or that the order was unreasonable or plainly unjust so that the Court should infer that in some way there had been a failure to properly exercise the discretion. AVN did not even attempt to do this. I certify that the preceding one (1) numbered paragraph is a true copy of the Reasons for Judgment of the Honourable Justice Katzmann.

REASONS FOR JUDGMENT (Revised from the transcript) WIGNEY J: 54 I agree with Rares J that the orders made by the primary judge were interlocutory in character and that leave is therefore necessary before an appeal against them can be entertained. The dismissal of the application as incompetent did not finally dispose of the rights of the parties in the requisite sense: SZAJB v Minister for Immigration and Citizenship (2008) 168 FCR 410 at [23] (French J, with whom Allsop and Tracey JJ relevantly agreed at [68]-[70] and [114] respectively). This is not a case where it could be said that the primary judge's finding that the application was incompetent flowed from or involved any findings in respect of the merits of the application: cf Lloyd Werft Bremerhaven GmbH v Owners of Ship "Zoya Kosmodemyanskaya" (1997) 79 FCR 71, discussed in SZAJB at [19]-[23] (French J) and [68] (Allsop J). 55 I also agree with Rares J that leave to appeal should be refused. That is because the applicant has not presented any serious issues for argument that the primary judge erred in finding that the applicant did not have standing. Nor has the applicant raised any serious issues concerning the primary judge's evidentiary rulings or findings in respect of costs. 56 I am unpersuaded that the primary judge's evidentiary rulings were erroneous, particularly having regard to the way that the issues surrounding the impugned evidence were dealt with before her Honour. In particular, the arguments which the applicant sought to raise in this Court concerning s 136 of the Evidence Act 1995 (Cth) were not squarely raised before her Honour. In any event, much, if not all, of the evidence upon which the s 136 limitation was imposed was inadmissible hearsay, inadmissible opinion evidence, or bare assertions which were deserving of little, if any, weight. 57 As for the primary judge's findings concerning standing, her Honour applied the correct principles as articulated by binding High Court authority, in particular Australian Conservation Foundation Incorporated v The Commonwealth (1980) 146 CLR 493. The applicant's arguments to the contrary have no merit. Her Honour's application of those principles to the facts as found was, in my view, also plainly correct and not attended by any sufficient doubt to warrant the grant of leave to appeal. 58 Finally, the applicant failed to identify any error, let alone any error of principle, in respect of the primary judge's discretionary judgment in respect of costs. I certify that the preceding five (5) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Wigney.