Allied BioServices and Minister for Health and Aged Care (Practice and Procedure)

[2024] ARTA 50

Allied BioServices and Minister for Health and Aged Care (Practice and Procedure) [2024] ARTA 50 (29 November 2024) 

Applicant:Allied BioServices

Respondent:  Minister for Health and Aged Care

Tribunal Number:                2023/7007

Tribunal:General Member Darian-Smith

Place:Sydney

Date:29 November 2024  

Decision:The Tribunal refuses the Respondent’s application seeking an order that the Applicant’s application for review be dismissed under s. 101(1)(b) of the Administrative Review Tribunal Act 2024 (Cth).

..............................[SGD]..........................................

General Member Darian-Smith

Catchwords

PRACTICE AND PROCEDURE - dismissal application-s.101(1)(b) Administrative Review Act 2024 (Cth) - whether application has no reasonable prospects of success-whether Tribunal’s determination of the application for review would be futile - issue concerning whether the intended purpose is a” residual activity claim” a mixed question of fact and law – the need for evidence necessitates a hearing - application for dismissal refused

Legislation

Administrative Appeals Tribunal Act 1975 (Cth) s.42B(1)(b)
Administrative Review Tribunal Act 2024 (Cth) s.101(1)(b)

Therapeutic Goods Act 1989 (Cth) ss. 9D(3), 4, 10, 14A, 19B, 19D, 21A, 21B, 22, 25, 26, 60

Cases

Minister for Immigration and Citizenship v Li (2013) 249 CLR 332
Re Filsell and Comcare (2009) 49 AAR 506
Kristoffersen and Secretary, Department of Social Services [2018] AATA 524
Merante and Secretary, Department of Employment [2017] AATA 1178
Re DZXP, KRQD and QJJS and Innovation and Science Australia [2017] AATA 576; ((2017)72 AAR 42
Paraponiaris and Secretary, Department of Employment [2015] AATA 895

Saitta Pty Ltd & Anor v Commonwealth of Australia & Ors (2000) 106 FCR 554

Statement of Reasons

1. This proceeding is an application for review of the decision of the Respondent’s delegate on 23 August 2023[1] (Reviewable Decision), made under s.60 of the Therapeutic GoodsAct 1989 (Cth) (TG Act), affirming the earlier decision of the Secretary of the Department of Health and Aged Care made 9 June 2023.

   [1] T02.

2. That earlier decision, made under s. 9D(3) of the TG Act, was a decision not to vary the entry in the Australian Register of Therapeutic Goods (ARTG) relating the Applicant’s product, a hospital grade disinfectant named Surface Wise 2[2] (SW2).

   [2] ARTG 350710.

3. The application for review of the Reviewable Decision was lodged by the Applicant on 22 September 2023.

4. On 8 March 2024, the Respondent made an application to the Tribunal under s.42B(1)(b) of the Administrative Appeals Tribunal Act 1975 (Cth) (AAT Act) (now s.101(1)(b) of the Administrative Review Tribunal Act 2024 (Cth) (ART Act)), for dismissal of the Applicant’s application for review on the ground that the application for review “has no reasonable prospects of success” (Respondent’s Dismissal Application).

   THE TG ACT FRAMEWORK

5. The objects clause of the TG Act states, in part:

   (1) The objects of this Act are to do the following, so far as the Constitution permits:

   (a)provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are:

   (i)used in Australia, whether produced in Australia or elsewhere; or

   (ii)exported from Australia;[3]

   [3] TG Act s.4(1)(a).

6. The regulation of therapeutic products such as SW2 occurs under Chapter 3 of the TG Act. That regulation includes the standards required of a therapeutic good or class of therapeutic goods (Chapter 3, Part 3-1) and the requirements for therapeutic goods to be registered by their listing on the ARTG and matters relating to that listing (Chapter 3, Part 3-2).

7. The TG Act provides for the Minister to make an order by legislative instrument “determining that matters specified in the order constitute a standard for therapeutic goods or a class of therapeutic goods identified in the order.”[4] The order establishing a standard can specify matters including by reference to the quality of the goods.[5]

   [4] TG Act s.10(1).

   [5] TG Act s.10(2).

8. Non-compliance with standards imposed under the TGA Act framework can give rise to an offence and liability for civil penalties. Relevantly, the Applicant would commit an offence[6] if a therapeutic good were to be supplied, imported, or exported by it in breach of a standard without the prior consent of the Secretary of the Department of Health and Aged Care (Secretary). The Secretary can refuse to list SW2 on the ARTG, if he is satisfied that SW2 does not conform to a standard applicable to it.[7]

   [6] TG Act s.14A.

   [7] TG Act ss. 25(1) (f), 26(1)(f).

9. Further, in relevant cases, the TG Act imposes compliance with standards which apply to certain listed products, for example disinfectants and sanitary products. The listing of SW2 on the ARTG is subject to a condition of listing that “The listed goods must comply with standards applicable to those goods under part 3 of the Act.”[8] Civil penalties also apply to a failure to comply with a condition of listing.[9]

   [8] Public Summary for ARTG entry 350710 Specific Condition 1: see Respondent’s Dismissal Application Annexure A.

   [9] TG Act ss. 21A(5) -(8A), 21B(2).

10. There is a mandatory product standard for disinfectants, the Therapeutics Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 (Cth) (TGO 104), which the parties agree is applicable to SW2. A range of requirements is imposed by TGO 104 in relation to disinfectants including about the data needed to substantiate the stability, safety, and performance of listed disinfectants.

11. Claims in respect of the capabilities of a disinfectant are treated as claims of residual activity for the purposes of TGO 104. “Residual activity” is defined in TGO 104 as: “the capability of a disinfectant to continue to reduce the number of viable cells of a relevant test organism on a surface, when the disinfectant is used in accordance with the information provided on the label of the disinfectant.”[10]

    [10] TGO 104 s.4.

12. TGO 104 further provides[11] that where a claim of residual activity is made in relation to a disinfectant, that claim is to “be based on residual activity that is established in accordance with the requirements” in the TGA Instructions for disinfectant testing (Version 3.0, December 2021) (TGA Instructions).[12] Importantly for present purposes, the TGA Instructions provide that the “period over which residual activity against bacteria, yeast or viruses is claimed must not be more than 30 days.”[13]

    [11] TGO 104 s.14A(b).

    [12] See Respondent’s Dismissal Application Annexure B.

    [13] TGA Instructions, page 22.

13. The listing of SW2 on the ARTG is critical to the Applicant’s ability to lawfully import, export, manufacture, or supply SW2 in Australia.[14] The initial listing of a disinfectant such as SW2 takes place under s.26 of the TG Act, at which time the Applicant for listing nominates an “intended purpose” for inclusion in the ARTG entry for the product. The nominated “intended purpose” for the ARTG entry is the only purpose for which SW2 can lawfully be advertised[15].

    [14] TG Act ss. 19B, 19D. Penalties apply for import, export, manufacture or supply unless the goods are listed goods, exempt goods or the subject of an approval or authority under the TG Act.

    [15] TG Act ss. 21B(4), 22(3)-(5).

14. Variation of entries in the ARTG is governed by s.9D of the TG Act. Section 9D(3) provides, so far as relevant:

    “If: (a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary information included in the entry in the Register that relates to the goods; and …(c) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used; the Secretary may vary the entry in accordance with the request.”

15. The discretion in s.9D(3) of the TG Act, to be exercised by the Secretary, is not an unfettered discretion. It is a statutory discretion of the kind considered by the High Court in Minister forImmigration and Citizenship v Li,[16] and is, as described by French CJ, “confined by the subject matter, scope and purpose of the legislation under which it is conferred.”[17] Within, and having regard to those constraints, the Secretary must exercise his discretion reasonably.

    [16] (2013) 249 CLR 332.

    [17] (2013) 249 CLR 332, 348 at [23]. See also at 363 (Hayne, Kiefel and Bell JJ), 370 (Gageler J).

    CHRONOLOGY OF “INTENDED PURPOSE”

16. The initial listing of SW2 on the ARTG occurred in 2020. At that time, the intended purpose of SW2 was stated as: “Advanced BioServices SurfaceWise2 is a Hospital-grade disinfectant against germs, bacteria and COVID-19. Not to be used on skin.”[18]

    [18] T41.01, Respondent’s Materials p.587.

17. The intended purpose of SW2 was varied in May 2021 (May 2021 variation), to include a residual activity claim. The varied intended purpose for SW2 was then stated as: “SurfaceWise 2 is a Hospital-grade disinfectant against germs, bacteria and COVID-19. SurfaceWise 2 is a hard surface disinfectant that forms a protective coating to provide residual efficacy on surfaces to reduce germs by up to 98.5% over 15 weeks. Not to be used on skin.”[19]

    [19] T41.01, Respondent’s Materials, p.588.

18. The Respondent’s explanation for allowing the May 2021 variation to include a 15 week residual activity claim turns on the facts that in May 2021 nether TGO 104 nor the TGO Instructions imposed restrictions in relation to residual efficacy claims. At that time, residual efficacy claims were not limited to 30 days duration.[20]

    [20] Respondent’s Dismissal Application at [25].

19. On 1 January 2022, TGO 104 was amended to include a definition of “residual activity.” Further mandatory requirements were included for claims of residual activity, which stated that such claims:

    (a)must only relate to bacteria, yeast, or viruses; and

    (b)must be based on residual activity that is established in accordance with the requirements of Division 2 of Part 2 of the TGA Instructions.

20. The relevant version of the TGA Instructions was the one published in December 2021. The TGA Instructions included, in Division 2 Part 2, a section dealing with “Residual activity claims.” The testing requirements needed to support a residual activity claim were also set out in Division 2 Part 2 of the TGA Instructions, and a specific time limitation was imposed on the duration of a residual activity claim of “not more than 30 days”.[21]

    [21] TGA Instructions, pp. 22, 24.

21. After TGO104 was amended, the Respondent asked the Applicant to submit a request to vary the intended purpose with the wording it had been varied to by the May2021 variation, so that the intended purpose could be assessed against the new TGO104 requirements.[22] On 2 May 2022, the Applicant made an application to vary the entry for SW2 on the ARTG.[23]

    [22] T41.01, page 588.

    [23] T03.

22. On 9 June 2023, an initial decision was made by the Respondent’s delegate, which rejected the Applicant’s application to vary the entry for SW2.[24] On 23 August 2023, that decision was affirmed by the Reviewable Decision.

    [24] T41.01.

23. The grounds for the Reviewable Decision included that the proposed intended purpose made a residual activity claim with a stated duration period of 15 weeks, in circumstances where the maximum allowable duration for a residual activity claim was 30 days. A further ground was that the required testing requirements to support the claim had not been satisfied.[25]

    [25] T41.01, page 590; T02, pages 17-18.

24. On 22 September 2023, the Applicant lodged its application for review of the Reviewable Decision. In its application for review the Applicant set out the intended purpose which it seeks to have incorporated into the SW2 entry on the ARTG (Proposed Intended Purpose) in the following terms:

    “SW2 is a Hospital-grade disinfectant that is effective against Germs, Bacteria and COVID-19. SW2 is a hard surface disinfectant that forms a protective coating to provide residual efficacy even with regular cleaning. SW2 has been formulated to only need to be reapplied every 15 weeks. Not to be used on skin.”[26]

    [26] T01, page 5; T05, page 27.

    DISMISSAL: THE TRIBUNAL’S POWER AND APPLICABLE PRINCIPLES

25. The Tribunal’s power to dismiss an application at the time the Respondent’s Dismissal Claim was made, was contained in s.42B(1)(b) of the AAT Act, which allowed the Tribunal to “dismiss an application for the review of a decision, at any stage of the proceeding, if the Tribunal is satisfied that the application…(b) has no reasonable prospect of success.”

26. Section 101(1)(b) of the ART Act, which now applies, is expressed in substantially the same terms.

27. In Re Filsell and Comcare[27] (Filsell), DP Jarvis identified the applicable principles to be followed on an application for dismissal of proceedings under s.42B on the ground that the proceedings are frivolous and vexatious. The Tribunal explained the sense in which the concepts frivolous and vexatious might be understood in the context of a dismissal application as follows:

    “In the present matter it has not been contended on behalf of Comcare that the proceedings are frivolous or vexatious in the sense that they have been instituted frivolously or with the intention of annoying or embarrassing Comcare or that they have been brought for a collateral purpose; rather it is contended that the proceedings have no reasonable prospect of success, so that it would be futile for the proceedings to continue.”[28]

    [27] (2009) 49 AAR 506.

    [28] (2009) 49 AAR 506, 515 [34]. Filsell was decided before the 2015 amendments to the AAT Act pursuant to the Tribunals Amalgamation Act 2015 (Cth), which added “no reasonable prospect of success” to s.42B.

28. The applicable principles to be taken from Filsell are:

    (a)“The power of the tribunal to dismiss proceedings under s.42B is a power that should be used cautiously.”[29]

    (b)“However, if proceedings have no reasonable prospect at all of success, they should be dismissed under s. 42B, since it would be futile for the proceedings to continue, and inappropriate to use the time and resources of this tribunal, and to put the respondent to the expense that would be involved in the matter proceeding to a hearing.”[30] and

    (c)“Conversely, applications to dismiss under s.42B should not be made except in appropriate cases.”[31]

    [29] (2009) 49 AAR 506 [33(c)].

    [30] (2009) 49 AAR 506 [33(d)].

    [31] (2009) 49 AAR 506 [33(e)].

29. In Kristoffersen and Secretary, Department of Social Services[32] (Kristoffersen), decided after the dismissal consideration of “has no reasonable prospect of success” into s.42B, SM Tavoularis summarised the principles governing dismissal of applications as follows:

    (a)The power to summarily dismiss a proceeding must be attended with caution and not exercised lightly.

    (b)The test of “no real prospect of success” sets a higher standard than that followed under the previous form of s.42B(1), whereby the power to dismiss was limited to an application that the Tribunal was satisfied as being frivolous or vexatious.

    (c)For the Tribunal to be satisfied of “no real prospect” of success of a given application, there must exist “a high degree of certainty about the ultimate outcome of the proceeding if it were allowed to go to [hearing] in the ordinary way.

    (d)Reaching (or not reaching) the “no prospect of success” standard involves an assessment of an application’s merits to ascertain whether it can reasonably sustain any reasonable contention or line of argument; and

    (e)The threshold of satisfaction of the “no prospect of success” standard is not reached if the Tribunal apprehends that it is unlikely that an applicant will succeed on a question of law or fact (or both).”[33] [citations omitted]

    [32] [2018] AATA 524.

    [33] [2018] AATA 524 at [10].

30. The Tribunal in Kristoffersen endorsed[34] what was said by the Tribunal in Merante and Secretary, Department of Employment[35] (Merante), at paragraph [17] of DP Forgie’s reasons for decision in Merante, where the Tribunal (relevantly) states:

    “[the application for dismissal] is not a situation in which it is appropriate to undertake a full scale consideration of the merits of the application. If, on the facts as asserted by the applicant on a view of the law that is arguable- or that at least leaves open some room for doubt as to whether it is correct or not- the applicant would have some measure of success in varying or setting aside the decision under review, it cannot be said that an applicant has no prospect of success. It does not matter at this stage whether the assertions of fact are supported by evidence or not. Evidence is a matter for any substantive hearing.”[36]

    [34] [2018] AATA 524 at [11].

    [35] [2017] AATA 1178.

    [36] [2017] AATA 1178 at [17].

31. The Tribunal was referred to its decision in Re DZXP, KRQD and QJJS and Innovationand Science Australia[37] (DZXP), which in addition to citing the principles in Filsell, sets out some further points of principle:

    (a)The Tribunal has made it clear that the dismissal power in s.42B is to be used cautiously and sparingly. That is, if a legitimate purpose could be achieved by allowing the application to continue, it should not be prevented: Re MarnottaPty Ltd and Department of Health and Aging [2024] AATA 326; Re Hinds and AustralianNational University (2012) 129 ALD 476. However, if the application can serve no purpose for the applicant, it should not continue to use Tribunal time and resources: Re Williamsand Australian Electoral Commission (1995) 21 AAR 467; Re Currey and AustralianCommunity Pharmacy Authority (2007) 99 ALD 107.”[38]

    (b)The genuineness of the applicant’s belief may be relevant where the subject matter of that belief is factual rather than legal in nature. The applicant’s belief must yield however, where it is concluded as a matter of law that there is no legitimate purpose to be achieved by continuing with the proceeding.[39]

    (c)A decision to dismiss proceedings as having no reasonable prospect of success “necessarily involves a consideration of the merits, in the sense that it requires a finding that the application cannot succeed.”[40]

    (d)In a case where there is no dispute as to the facts, it is open to the Tribunal to dismiss an application which only concerns a question of law.[41] The Tribunal cited the decision of DP Alpins in Paraponiaris and Secretary, Department of Employment[42] (Paraponiaris), which relevantly states: ‘where the success of an application for review depends upon propositions of law said to arise from relevant legislative provisions which are not sufficiently tenable as a matter of proper statutory interpretation, in my opinion it is open to the Tribunal to be satisfied that the application has no reasonable prospect of success for the purposes of s.42B(1)(b).”

    (e)The concept of whether an application has “no reasonable prospect of success extends to whether, as a matter of substance, the review by the Tribunal will have any utility or useful outcome. The Federal Court and Tribunal have found on a number of occasions that if an application cannot serve a purpose for an applicant, it should not continue.”[43]; and

    (f)The cost that a respondent will incur in defending a claim which lacks a practical outcome is also a relevant consideration.”[44]

    [37] [2017] AATA 576;(2017) 72 AAR 42.

    [38] (2017) 72 AAR 42, 48 [33].

    [39] (2017) 72 AAR 42, 48 [34].

    [40] (2017) 72 AAR 42, 49 [36].

    [41] (2017) 72 AAR 42, 50 [38].

    [42] [2015] AATA 895.

    [43] (2017) 72 AAR 42, 50 [39]. An example was given at [42]-[43] by the Tribunal of a case in which a hearing would have been futile: Re Canberra Raiders Sports Club and Commissioner for ACT Revenue (1999) 59 ALD 229.

    [44] (2017) 72 AAR 42, 50 [41].

    THE PARTIES’ SUBMISSIONS

1. The Respondent’s Dismissal Application identified three issues for determination on the dismissal application as follows:

   (a)whether the intended purpose which the Applicant seeks under its application for variation in the ARTG for SW2 under s.9D(3) of the TG Act is a “residual activity claim”.

   (b)if so, whether the duration of that residual activity claim is inconsistent with TGO 104, the mandatory product standard for disinfectants; and

   (c)if so, whether there is a reasonable prospect that the Tribunal would consider it appropriate to vary the intended purpose of SW2 in circumstances where that would result in SW2 failing to conform with TGO 104.[45] (Issues for Determination)

   [45] Respondent’s Dismissal Application at [2].

2. The Respondent’s principal submissions made in support of the proposition that the Applicant’s application for review has no reasonable prospects of success are as follows:

   (a)the Applicant’s application seeks to vary the intended purpose of SW2 to the Proposed Intended Purpose, which makes a claim that SW2 will have residual activity for a period of 15 weeks.

   (b)that residual activity claim is for a period longer than the 30 days permitted under the TGA Instructions and, if the entry in the [ARTG] for SW2 were varied to include the Proposed Intended Purpose, SW2 would therefore not comply with TGO 104; and

   (c)it is not open to the Tribunal to exercise the s.9D(3) power in a manner that would result in the relevant product failing to comply with a standard, as such an outcome would be inconsistent with the national system of controls established by the TG Act and would result in the Applicant contravening the TG Act.”[46]

   [46] Respondent’s Dismissal Application at [31].

3. If accepted by the Tribunal, those principal submissions would lead to a “yes” answer to each of the Issues for Determination, which would then provide a proper basis for the Tribunal to dismiss the application for review, because, as a matter of law, the Applicant would have no reasonable prospects of success.

4. Each of the Respondent’s principal submissions is subsequently expanded upon in the Respondent’s Dismissal Application, the submission in respect of the Proposed Intended Purpose at [32]-[34], the submission in respect of non-compliance with TGO 104 at [35]-[36] and the submission as to the decision maker not approving a variation of an entry to the ARTG if that resulted in the good being incapable of compliance with TGO 104 at [37]-[42].

5. In the Applicant’s Response to Dismissal Application dated 5 April 2024 (Applicant’s Response), it responded to the first of the Issues for Determination by characterising the Proposed Intended Purpose as a 105-day re-application claim rather than as a 30-day residual efficacy claim.[47] The distinction is drawn to support the Applicant’s argument that a 105-day re-application claim, while still falling under the TG Act, was not constrained by the operation of TGO 104 and the TGA Instructions as it would be if the Proposed Intended Purpose was properly characterised as a 30-day residual efficacy claim.

   [47] Applicant’s Response [4], [10], [11], [31], [66], [75], 116].

6. The Applicant explains the distinction between a residual efficacy claim and a re-application claim as follows: “A residual efficacy claim falls under “Efficacy” within the TG Act and subsequently the TGO 104 and TGA Instructions. By contrast, re-application frequency relates to a “performance characteristic” of the product which is defined under “Quality” within the TG Act.”

7. The Tribunal notes that the Respondent does not necessarily accept that the distinction drawn by the Applicant between a residual efficacy claim and a re-application claim made under the TG Act, is a valid distinction. Further, the Respondent appears not to have conceded as agreed facts that by its email dated 11 May 2022[48], the Applicant amended its claim to make it a re-application claim (not a residual activity claim) and the Respondent thereafter accepted the Applicant’s claim as a re-application claim.

   [48] T 05.02, Respondent’s Materials page 27.

8. The Respondent’s Reply Submissions dated 19 April 2024 (Respondent’s Reply to Response) identifies the three arguments which are raised in the Applicant’s Response as:

   (a)the 30-day limit on residual efficacy claims established by the TGA Instructions (Residual Claim Limit) is in “direct conflict” with TGO 104 and the TG Act. As such, the Proposed Intended Purpose does not need to comply with the Residual Claim Limit.

   (b)the Proposed Intended Purpose does not make a 15-week residual efficacy claim and therefore does not conflict with the TGA Instructions; and

   (c)in any event, if the Proposed Intended Purpose was approved by the Tribunal, the approval would enable SW2 to be supplied, imported and exported “under the authority of the Secretary”, resolving any issues caused by the Proposed Intended Purpose being inconsistent with TGO 1204 and the TGA Instructions.”[49]

   [49] Respondent’s Reply to Response, [4].

9. The Respondent rejects each of these three arguments.

10. In respect of the first argument, the Respondent says that the Residual Claim Limit of 30 days is validly and properly imposed by TGO 104. The Respondent relies upon an argument that the Residual Claim Limit is entirely consistent with the legislative basis of TGO 104 and the TGA Instructions[50]. In oral submissions, Mr Wong, for the Respondent, did not press the Respondent’s written submissions in relation to a second reason for the rejection of this argument[51], which turned on the Tribunal’s lack of power to deem TGO 104 and/or the TGA Instructions invalid and/or to otherwise exclude SW2 from the operation of these instruments.

    [50] Respondent’s Reply to Response, [8]-[11].

    [51] Respondent’s Reply to Response, [12]-[14] were withdrawn.

11. On the latter point, counsel for the Respondent referred the Tribunal to Saitta & Anor vCommonwealth of Australia & Ors[52], where Weinberg J. stated that the AAT could consider, in a particular case[53], the question of the validity of delegated legislation in arriving at a decision as to whether steps taken in reaching a reviewable decision were lawfully taken[54].

    [52] (2000) 106 FCR 554.

    [53] (2000) 106 FCR 554 at [103].

    [54] Without exercising judicial power, for example by granting declaratory relief.

12. In respect of the second argument, the Respondent says that the Proposed Intended Purpose in fact makes a 15-week residual efficacy claim[55]. It rejects the Applicant’s proposed approach to the separate independent reading of each sentence of the Proposed Intended Purpose as “artificial” and as not according to how it would be read by an ordinary and reasonable person[56].

    [55] Respondent’s Reply to Response, [15]-[22].

    [56] Relying on the authorities canvassed in the Tribunal’s decision in Cat Media Pty Ltd, Carotino (Australia) Pty Ltd, Pharm-a Care Laboratories Pty Ltd and Minister for Health and Aged Care [2023] AATA 2792, [27]-[35].

13. In respect of the third argument, the Respondent submits that if the Proposed Intended Purpose was approved by the Tribunal, it would result in a revised entry for SW2 in the ARTG which was unlawful. Such an outcome would be inappropriate and contrary to the objects of the TG Act. It follows that the Tribunal should not exercise the discretion in s.9D(3) in that manner.[57] Further, the Respondent contends that the application under review is futile, as, even if the Applicant was to be successful, the Tribunal has no means of enabling the supply, import or export of SW2 for the Proposed Intended Purpose.[58]

    [57] Respondent’s Reply to Response, [23]-[27].

    [58] Respondent’s Reply to Response, [26]-[28].

14. Mr Wong, in his oral submissions, urged the Tribunal to exercise its power to dismiss the application for review based on the application of the relevant legal principles, without the need for evidence to be filed to determine the application.

15. There were said by the Respondent to be no reasonable prospects of success because the Tribunal would not be able to exercise the discretion in s.9D(3) favourably to the Applicant, without that outcome being in breach of TGO 104 and the entry as varied liable to cancellation under s.30 of the TG Act. Further, the determination sought by the Applicant was said not to have any material benefit for the Applicant, because the variation process had been established for the very purpose of allowing a listed product to be brought into line with TGO 104 and the application for review could not achieve that purpose.

16. In respect of the Applicant’s submission that the Tribunal should make a finding, if necessary, that TGO 104 and/or the TGA Instructions were invalid, the Respondent submitted that there was no compelling basis for approaching the Reviewable Decision on the basis that either TGO 104 or the TGA Instructions were invalid.

17. In relation to the Applicant’s argument that the Proposed Intended Purpose was not a “residual activity claim”, the Respondent’s position was that the Applicant had not identified any statutory basis to support its characterisation of the Proposed Intended Purpose as a re-application claim.

18. The Respondent also looked at each of the three suggested possible amendments to the Intended Purpose and the product label set out in the Applicant’s email dated 7 November 2024[59], and submitted that none of the proposed re-formulations would get around the prohibitions which made the Proposed Intended Purpose unacceptable.

    [59] A7.

19. The Applicant’s oral submissions focussed on its contentions that the Proposed Intended Purpose was referrable to a performance characteristic of SW2, that the Applicant was making a re-application claim under the TG Act, not a residual activity claim, and accordingly the Proposed Intended Purpose did not need to satisfy the 30-day efficacy claim requirements under TGO 104 and the TGA Instructions.

20. Mr Smith, for the Applicant, in his oral submissions, explained why the SW2 product was “unique” and the difficulties which the Applicant had experienced in fitting the product within the TG Act listing process. The Applicant put a series of propositions to the Tribunal including that:

    (a)SW2 forms a protective barrier or coating on a hard surface and the 30-day efficacy claim requirements imposed by TGO 104 and the TGA Instructions do not apply to a coating claim.

    (b)SW2 is a combination product, which combines a short-acting disinfectant and a long-lasting anti-microbial product.

    (c)the Respondent, by its conduct, had agreed that the Applicant was making a re-application claim. That conduct was said to include discussions had by the Applicant with Ms. Schum, a senior representative of the TGA, and the way in which testing was approached by each of the two micro-biologists involved in reviewing the Applicant’s application to amend the Intended Purpose.

    (d)there was disagreement between the parties as to whether the supporting data supplied by the Applicant in support of its application for amendment of SW2’s ARTG listing was compliant with TGO 104. The Applicant contends that at least the senior micro-biologist confirmed that the data provided met the requirements of TGO 104; and

    (e)there was no evidence before the Tribunal which went to the question of whether a quality-based claim could be brought within, or without, of the boundaries of the “residual activity” claim process.

21. Matters (a)-(e) in the preceding paragraph were all contested to a greater or lesser extent by the Respondent. However, what those matters, either individually or in combination, have in common is that they raise issues of fact or of mixed fact and law. For the Tribunal to be able to appropriately assess, both as to relevance and weight, the factual component of the Applicant’s submissions, there will be a need for some evidence to be filed.

    CONSIDERATION: SHOULD THE APPLICATION FOR REVIEW BE DISMISSED?

22. It can be difficult in an interlocutory hearing for dismissal, being heard before any evidence or Statements of Facts Issues and Contentions have been filed, for the Tribunal to assess the strength, or otherwise, of the application for review. The Tribunal can however assess whether the Applicant appears to have, on the material then before it, an arguable case on the merits.

23. Turning to the principles concerning dismissal earlier distilled (at paragraphs 27-31 above) from the Filsell, Kristoffersen, Paraponiaris and DZXP decisions, I state my conclusions in the paragraphs below.

24. The Tribunal’s power to dismiss must be “attended with caution and not exercised lightly” (Kristoffersen) and is to be used “sparingly” (DZXP), and where no legitimate purpose can be achieved by allowing the application to continue.

25. The Respondent has sought to reduce the issues in the Applicant’s case to a series of questions of law, which would allow for the approach described in Paraponiaris (see paragraph 31(d) above). As the Tribunal has concluded, it is not possible to resolve satisfactorily the first of the Issues for Determination (the question of whether the Proposed Intended Purpose is a “residual activity claim”) without it engaging with questions of fact or mixed questions of fact and law. These factual matters are disputed, and evidence will need to be adduced, at least by the Applicant, for necessary findings of fact to be made by the Tribunal.

26. Applying the “no real prospect of success” test, as it is expressed in Kristoffersen, requires the Tribunal to have a high degree of certainty about the ultimate outcome of the proceeding at hearing. It requires the Tribunal to conclude that the Applicant cannot “reasonably sustain any reasonable contention or line of argument.” Using the language of DXZP, to dismiss the Applicant’s case at this point would require the Tribunal to make “a finding that the application cannot succeed.” Reaching the threshold of “no prospect of success”, will require more than an apprehension that the Applicant is unlikely to succeed on questions of law or fact. In my view, that threshold has not been reached in this case.

27. In DXZP, reference was made to the “genuineness of the applicant’s belief” as to factual matters, being of relevance in some cases. This proceeding is such a case. This is not a case where the Applicant’s genuine belief as to matters of fact must yield because as a matter of law no legitimate purpose is to be achieved by continuing with the proceeding.

    DECISION

28. While the Tribunal accepts that this is an appropriate case for the Respondent to ask the question about summary dismissal of the application for review[60], the Tribunal is ultimately not satisfied that the dismissal application should be upheld. The resolution of at least the first Issue for Determination concerning whether the intended purpose is a “residual activity claim” will necessitate the parties going into evidence, which in turn dictates the need for a hearing at which the evidence can be tested.

    [60] Filsell (2009) 49 AAR 506, 514 [33(e)]

29. The Tribunal refuses the Respondent’s application seeking an order that the Applicant’s application for review be dismissed under s.101(1)(b) ART Act.

Date(s) of hearing:	21 November 2024
Advocate for the Applicant:	Mr T Smith, CEO Allied Bio Services
Solicitors for the Respondent:	Mr C Wong, Senior Lawyer Department of Health and Aged Care