Cat Media Pty Limited, Carotino (Australia) Pty Limited, Pharm-a-Care Laboratories Pty Ltd and Minister for Health and Aged Care
[2022] AATA 1254
•13 May 2022
Cat Media Pty Limited, Carotino (Australia) Pty Limited, Pharm-a-Care Laboratories Pty Ltd and Minister for Health and Aged Care [2022] AATA 1254 (13 May 2022)
Division:GENERAL DIVISION
File Number(s): 2022/3059
Re:Cat Media Pty Limited, Carotino (Australia) Pty Limited, Pharm-a-Care Laboratories Pty Ltd
APPLICANT
AndMinister for Health and Aged Care
RESPONDENT
DECISION
Tribunal:Chris Puplick AM, Senior Member
Date:13 May 2022
Place:Sydney
The Tribunal makes the following decisions:
(a)the application for a stay order which would continue the existing interim order granted by this Tribunal on 2 May 2022 under subsection 41(2) of the Administrative Appeals Tribunal Act 1975 (Cth) (AAT Act) is refused; and
(b)the application for a confidentiality and non-publication order which would continue the existing interim order granted by this Tribunal on 2 May 2022 under subsection 35(3) of the AAT Act over the Applicants’ names is refused; and
(c)the application for a confidentiality and non-publication order under subsections 35(3) and 35(4) of the AAT Act in respect of the name of the product and the fact that a decision has been made in relation to that product, or any product of the Applicants is refused.
The Tribunal also directs pursuant to subsection 35(4) of the Administrative Appeals Tribunal Act 1975 (Cth), that on the ground that the order is necessary to prevent prejudice to the proper administration of justice, the information contained in Confidential Exhibit AJR-3, Confidential Exhibit AJR-4 and Confidential Exhibit AJR-5 to the Statutory Declaration of Anthony John Robertson declared on 22 April 2022 must not be published or otherwise disclosed to any person other than the parties or their legal representatives.
.....................................[sgd].................................
Chris Puplick AM, Senior Member
CATCHWORDS
PRACTICE AND PROCEDURE – request for stay order – request for non-publication order – decisions under review to cancel listing on Australian Register of Therapeutic Goods – factors to be considered in deciding whether to grant a stay – prospects of success – securing an effective review – interests to be considered – interest of the parties – general public’s interest – stay refused – non-publication order refused – existing non-publication order maintained
LEGISLATION
Administrative Appeals Tribunal Act 1975 (Cth) ss 35, 41
Therapeutic Goods Act 1989 (Cth) ss 3, 4, 26A, 26BF 30, 60
CASES
Alphapharm Pty Ltd v Smithkline Beecham (Australia) Pty Ltd and Ors (1994) 32 ALD 71
Australian Academy of Commerce Pty Ltd and Australian Skills Quality Authority [2020] AATA 3755
Australian College of Vocational Studies Pty Ltd and Australian Skills Quality Authority [2018] AATA 1088
Australian International College Pty Ltd v Australian Skills Quality Authority [2018] FCA 2097
Australian Securities and Investments Commission v PTLZ [2008] FCAFC 164
Australian Securities and Investments Commission (ASIC) v Administrative Appeals Tribunal [2009] FCAFC 185
Australian Vocational Learning Centre Pty Ltd and Australian Skills Quality Authority [2018] AATA 4725
Birdseye v Tax Practitioners Board [2020] FCA 1235
Bundy and Anor and Australian Securities and Investments Commission [2013] AATA 59
Collector of Customs (NSW) v Brian Lawlor Automotive Pty Ltd (1979) 24 ALR 307
Daly and Australian Securities and Investments Commission [2020] AATA 1516
Galaxy Day Care Pty Ltd and Secretary, Department of Education and Training [2018] AATA 4675
Griffiths, Grif-Air Helicopters Pty Ltd and Civil Aviation Authority [1993] AATA 274
Institute of Training Pty Ltd and Australian Skills Quality Authority [2018] AATA 4127
Kukulovski and A Committee convened under section 40-45 of the Insolvency Practice Schedule [2020] AATA 40
Liddle and Commissioner of Superannuation [1991] AATA 191
Madafferi v Minister for Immigration and Multicultural Affairs [2001] FCA 250
Mclean and Australian Securities and Investments Commission [2016] AATA 22
Menzies and Australian securities and Investments Commission [2016] AATA 699
Pandos and Commonwealth of Australia [1991] AATA 18
Panganiban and Australian Securities & Investments Commission [2016] AATA 703
Papatonakis v Australian Telecommunications Commission [1985] HCA 3
Pelling and Secretary, Department of Aviation (1984) 5 ALD 638
Phytologic Pty Ltd v Secretary, Department of Health [2012] 209 FCR 48
Poidevin and Australian Securities and Investments Commission [2018] AATA 124
Rust-Oleum Australia Pty Ltd and Australian Pesticides and Veterinary Medicines Authority [2017] AATA 298
Scott and Australian Securities and Investments Commission [2009] AATA 798
Technical Education Australia Pty Ltd and Australian Skills Quality Authority [2018] AATA 3047
Trades College Australia Pty Ltd and Australian Skills Quality Authority [2018] AATA 1703
SECONDARY MATERIALS
Chris Puplick, ‘Justice: Now Open to Whom’ (2002) 6(1) Judicial Review 95
John McEwen, A History of Therapeutic Goods Regulation in Australia (Canberra, September 2007): < Review, Naturopathica Fatblaster Max: < FOR DECISION
Chris Puplick AM, Senior Member
13 May 2022
BACKGROUND
On 10 January 2022 a delegate of the Minister for Health and Aged Care (the Respondent) made a decision to remove a product marketed under the name FatBlaster MAX from the Australian Register of Therapeutic Goods.
On 22 February 2022 the Applicants (Cat Media Pty Limited, Carotino (Australia) Pty Limited, Pharm-a-Care Laboratories Pty Ltd)[1] applied to the Respondent for a reconsideration of the cancellation decision.[2] However, on 13 April 2022 a delegate of the Minister confirmed that decision. The Applicants then applied on 14 April 2022 to this Tribunal seeking both a review of the cancellation decision and a stay of proceedings pursuant to subsection 41(2) of the Administrative Appeals Tribunal Act 1975 (Cth) (AAT Act).
[1] Being related companies involved in the sponsorship, promotion and manufacture of the product in question constituting a single entity for the purposes of these proceedings.
[2] Therapeutic Goods Act 1989 (Cth) (TGA Act) s 60.
The Applicants also sought an interim stay order from the Tribunal until a formal stay application could be heard and such a stay order was made by Deputy President Rayment effective to 3 May 2022. In addition, the Deputy President granted a non-publication order over the name(s) of the Applicants to that same date.[3]
[3] Administrative Appeals Tribunal Act 1975 (Cth) (AAT Act) s 35(3).
On 2 May 2022 the parties appeared before this Tribunal by phone to determine the Applicants’ formal application for stay and non-publication orders. Specifically, the Applicants sought non-publication in respect of their names (including request for pseudonyms), the name of their product and information that the Respondent’s decision was made regarding the specific product in question or a product of the Applicants.[4] After hearing their submissions I extended the existing interim stay and non-publication orders until close of business 13 May 2022. In addition, I ordered that certain evidence tendered before the Tribunal was not to be published or otherwise disclosed other than to the parties or their legal representatives.[5] This order was made on the basis of consent by the parties.
[4] In the case of non-publication of names, Applicants sought an extension of the existing orders, in the case of publication regarding the product itself, Applicants sought a new order.
[5] AAT Act s 35(4).
In these proceedings the only question to be determined is whether or not an order should be made staying proceedings (i.e. the delisting of the product) and granting non-publication orders until after the determination of the substantive application before the Tribunal.
LEGISLATIVE PROVISIONS – STAY ORDERS
In a number of cases I have outlined the relevant statutory provisions and the relevant authorities.[6]
[6] Australian Academy of Commerce Pty Ltd and Australian Skills Quality Authority [2020] AATA 3755.
Section 41 of the AAT Act governs the application for, and the making and variation of, a stay order and the imposition of conditions related to such orders:
41 Operation and implementation of a decision that is subject to review
…
(2) The Tribunal may, on request being made by a party to a proceeding before the Tribunal (in this section referred to as the relevant proceeding ), if the Tribunal is of the opinion that it is desirable to do so after taking into account the interests of any persons who may be affected by the review, make such order or orders staying or otherwise affecting the operation or implementation of the decision to which the relevant proceeding relates or a part of that decision as the Tribunal considers appropriate for the purpose of securing the effectiveness of the hearing and determination of the application for review.
…
(6) An order in force under subsection (2) (including an order that has previously been varied on one or more occasions under subsection (3)):
(a) is subject to such conditions as are specified in the order; and
(b) has effect until:
(i) where a period for the operation of the order is specified in the order – the expiration of that period or, if the application for review is decided by the Tribunal before the expiration of that period, the decision of the Tribunal on the application for review comes into operation; or
(ii) if no period is so specified – the decision of the Tribunal on the application for review comes into operation.
There are four crucial elements in subsection 41(2) which need to be satisfied in the granting of a stay order:
(a)the Tribunal must form an “opinion” which, logically, it can do only if there is sufficient evidence before it to allow this to be done;
(b)the Tribunal must determine whether it is “desirable” to grant a stay order;
(c)the basis for making a finding that it is “desirable” to grant the stay order must be “for the purpose of securing the effectiveness of the hearing and determination of the application for review”; and
(d)the Tribunal must make its decision “after taking into account the interests of any persons who may be affected by the review”.
AUTHORITIES
The courts have given extensive consideration to the matters which the Tribunal should take into account when dealing with stay applications.
Some guidance was provided in this Tribunal by then Tribunal President Downes J in the matter of Scott where the President said:[7]
Application having been made for a stay of proceedings under s 41 of the Administrative Appeals Tribunal Act 1975, it is nevertheless incumbent upon me now to consider whether a stay is appropriate. In considering the application, it is appropriate for me to consider a range of matters, including:
1. The prospects of success.
2. The consequence for the applicant of the refusal of a stay.
3. The public interest.
4. The consequences for the respondent in carrying out its functions depending upon whether a stay is granted or not.
5. Whether the application for review would be rendered nugatory if a stay were not granted.
6. Other matters that are relevant, amongst which I would include the length of time that the ban has already been in place and the gap between today and the hearing of the application.
[7] Scott and Australian Securities and Investments Commission [2009] AATA 798 at [4].
The issues for the Tribunal’s consideration in stay applications has also been elucidated by Senior Member Taylor SC in Panganiban to include:[8]
[8] Panganiban and Australian Securities & Investments Commission [2016] AATA 703 at [7].
(a) an applicant’s prospects of success, in obtaining a materially different outcome as a result of the review proceeding;
(b) the functions and responsibilities of the statutory decision maker, the nature and purpose of the reviewable decision, and the public interest in relation to it;
(c) the reasons proffered to support, or oppose, the stay application, and the potential practical consequences of any stay;
(d) the practical consequences of the decision under review (to the parties and to any interested persons), unless its operation is the subject of a relevant stay, after taking into account:(i) conditions that might be imposed as a term of any stay;
(ii) the timing of the reviewable decision, the application, and any likely review hearing;
(iii) the ability of the applicant to pursue the review proceedings effectively; and
(iv) the likely practical utility of any favourable review outcome.
It should also be noted that Deputy President Forgie, in reference to the “list” in Scott has observed that it “should not be regarded as a comprehensive list of all matters that may be relevant in a particular case.”[9]
[9] Trades College Australia Pty Ltd and Australian Skills Quality Authority [2018] AATA 1703 at [38].
In any case, the Federal Court has made it clear that the Tribunal must not simply adopt some sort of checklist approach to its decision-making process at the expense of “appreciating the overall statutory task as set out in section 41(2)”.[10]
[10] Birdseye v Tax Practitioners Board [2020] FCA 1235 at [20] per Logan J.
In Birdseye, Logan J explained:
… Nonetheless, it may be accepted that an applicant for a stay is in no way required to demonstrate that he, she, or it, as the case may be, must succeed upon a review on the merits of the decision. At most, all that one must show is that there is a basis in the material before the Tribunal for forming the opinion that it is “desirable”, in order to preserve the effectiveness of the review, to grant a stay. As to that, to use the term “onus” would be inapt, having regard to the very nature of the administrative review conducted by the Tribunal. That would be to adopt language from a different discourse, namely, that of an exercise of judicial power.
Nonetheless, it is, obviously, in the interests of an applicant to be able to point to something in the material before the Tribunal which engenders the requisite opinion as to desirability. That might be found in what was already before the primary decision maker whose decision is under review. It might be found not in factual material before that decision maker, but rather, in the approach to the construction of the statute empowering the making of the decision concerned. Thus, it may be that there is, even aside from any factual controversy, an arguable proposition of law. It may be each of those. The foundation may also be in additional material which was not before the primary decision maker but has been introduced, or at least can be shown to be reasonably in prospect of being introduced, having regard to the particular stage of the proceedings.
It, truly, is neither necessary, nor desirable, to set metes and bounds as to what may engender appropriately the requisite desirability opinion other than to observe that, as with any administrative decision, there must be some material before the Tribunal which is reasonably capable of engendering the requisite opinion.[11]
[11] Ibid at [23]-[25]. Citations omitted.
His Honour made it clear that what is required for a stay to be granted is that the applicant demonstrate that there is some basis in the material before the Tribunal which would lead it (the Tribunal) to an informed opinion that it is desirable, in order to preserve the effectiveness of the review process, that such a stay be granted.
Additionally, I have made further comments relevant to the determination of stay applications involving regulatory bodies. In Galaxy Day Care, I said:
Regulatory bodies are established, in part, to ensure that the public interest is protected in the areas of their competence and the Tribunal should be cautious about taking steps which may derogate from the protection of that public interest by failing to give due regard (although not unqualified deference) to their assessments in such matters. As the Tribunal said in Metro College “The regulatory regime assumes there is a public interest in ensuring these programs are properly run according to recognized standards.”[12]
[12] Galaxy Day Care Pty Ltd and Secretary, Department of Education and Training [2018] AATA 4675 at [43].
To quote again from this Tribunal’s own previous decision in Institute of Training:
It is important to note that the Administrative Appeals Tribunal, apart from exercising jurisdiction under the relevant provisions of specific statutes, and not having a general jurisdiction across all Commonwealth administrative decisions, is part of an administrative law system which should be conducted by reference to the “standards of good government”. It is an:
“instrument of government administration and designed to act where decisions have been made in the course of government administration but which are in the view of the Tribunal not acceptable when tested against the requirements of good government”.[13]
“Good government” includes both the protection of the public interest and protecting the integrity of the national vocational education system.[14]
[13] Collector of Customs (NSW) v Brian Lawlor Automotive Pty Ltd (1979) 24 ALR 307 at 334 per Smithers J.
[14] Institute of Training Pty Ltd and Australian Skills Quality Authority [2018] AATA 4127 at [70]-[71].
A STAY NOT A DECISION
It is expressly not the role of this Tribunal to pre-empt any decision on the merits of the case which must be left to a full hearing of the Tribunal in due course. As Deputy President Deutsch explained:
8. Arguments relating to prospects of success are fraught with danger in circumstances where little or no evidence has been provided in relation to the matters in dispute. Clearly, in considering prospects of success in a review application for the purposes of an interlocutory application, it is not the role of this Tribunal to conduct a preliminary hearing of the review application
9. It is relevant, however for the Tribunal to consider whether there are:
(a) facts or circumstances which, if established in the substantive hearing, would provide a basis for success in the review application; or
(b) points of law raised, which, if sustained, would lead to that conclusion.[15]
[15] Mclean and Australian Securities and Investments Commission [2016] AATA 22.Citations omitted).
However, it is necessary to at least understand the points of contention between the parties.
The starting point must be the legislation in question, the Therapeutic Goods Act 1989 (Cth) (TGA Act). It provides a scheme whereby certain products may be listed on the Australian Register of Therapeutic Goods (the Register). There are significant advantages, both commercial and reputational which accrue to sponsors whose products are so listed.
Section 26A of that Act governs “listing of certain medicines” and provides in relation to the labelling of such products (subsection 26A(2)):
(fba) if the medicine's label contains one or more indications--each indication:
(i) is covered by a determination under paragraph 26BF(1)(a); and
(ii) is proposed to be accepted in relation to the inclusion of the medicine in the Register; and
Paragraph 26BF(1)(a) empowers the Minister to make a determination in relation to a product’s “indications” which are defined as meaning, “the specific therapeutic uses of the goods” (subsection 3(1) of the TGA Act).
In other words, on the label of a listed product each claim, or statement of purpose or use must be one which has been approved by the Regulator.
The term “label” is defined in the TGA Act (subsection 3(1)) as:
label, in relation to therapeutic goods, means a display of printed information:
(a) on or attached to the goods; or
(b) on or attached to a container or primary pack in which the goods are
supplied; or
(c) supplied with such a container or pack.
In this instance, the label in question is effectively the front and back of a box in which certain tables are contained. The label includes the following text
“naturopathica
FatBlaster
MAX
To help:
·Improve exercise performance when dietary intake is inadequate
·Support metabolic rate
·Support thermogenesis
AUST L 348163
60 Film Coated Tablets
Contains Caffeine”.
In addition, there is an image of a flame (which may imply the concept of burning) on the box cover. The term “FatBlaster MAX” is written in three different colours and uses differing fonts. Together with the small-font name “naturopathica” it takes up approximately one-third of the label and the remaining text as set out above occupies the remainder.
The fundamental assertion of the Respondent is that consumers may be led to believe that FatBlaster MAX is in fact a weight-loss product whereas it has not been approved under paragraph 26A(2)(fba) for such a purpose.
In its review determination, an officer of the Therapeutic Goods Administration (TGA), (the Regulator) wrote:[16]
3. I have decided to confirm the initial decision on the basis that:
(a) it appears that the certification made by the applicant under paragraph 26A(2)(fba)of the Act, that each indication on the medicine’s label is proposed to be accepted in relation to the inclusion of the medicine in the Register, is incorrect (paragraph 30(1)(e) of the Act) (first ground);
(b) the certification made by the applicant under paragraph 26A(2)(fba) in relation to the listing of the medicine was false or misleading in a material particular (paragraph 30(1)(g) of the Act), as the applicant certified that each indication on the label was proposed to be accepted in relation to the inclusion of the medicine in the Register in circumstances where that was not the case (second ground); and
(c) the applicant has refused or failed to comply with a condition in which the inclusion of the medicine was subject to (paragraph 30(2)(c) of the Act) (third ground);
[16] Reviewable decision, Letter of the Minister’s delegate dated 13 April 2022 addressed to Ms Tobey Ann Pinder of Cat Media Pty ltd.
Paragraph 30(1)(e) of the Act relates to cancellation of a registration where registration conditions are “incorrect or… not fulfilled” and paragraph 30(2)(c) refers to cancellation where “the sponsor has refused or failed to comply with a condition to which the inclusion of the goods is subject”. Paragraph 30(1)(g) deals with cancellation where the regulator is “satisfied that a statement made in, or in connection with, the application for registration or listing of the goods was false or misleading in a material particular”.
In submissions to the Tribunal, the Respondent refers to
“those ordinary and reasonable consumers who would or may (wrongly) be led into thinking that the Product is for the therapeutic use of bringing about loss of body fat”
and
“the Minister’s position that the Product purports to be a weight loss product, yet is not so registered with such an indication.”[17]
[17] Respondent’s outline of submissions on application for stay and confidentiality order (undated) at [13] and [33] respectively.
The Applicants deny that the product is marketed as, or could be assumed to be, a weight loss product and that the brand-name FatBlaster MAX would not be so interpreted by any reasonable person. Hence, there is no failure to comply with the listing conditions of the TGA Act.
They submit:
“Put simply, the applicants contend that the Product’s trade mark — “FatBlaster” — indicates to consumers that the trade source of the goods is the same as other products within the range. It does not describe the kind, quality or intended use of the Product, and would not be understood by any reasonable consumer to be asserting that the Product can literally ‘blast’ ‘fat’ from a consumer’s body for the purpose of ‘weight loss’”.[18]
[18] Applicant’s written submissions on stay and non-publication dated 29 April 2022 at [36].
As already noted, it is not the role of this Tribunal to determine the validity or otherwise of any of the claims or assertions of either party, but rather to take this information as the basis of the evidence upon which it must determine the desirability of granting or not granting the stay order.
It is important to note that both parties accept that there is no issue of safety arising in relation to the sale of this product.
PROSPECTS OF SUCCESS
At the heart of this matter, to be determined in a merits review, is the relatively simple question, would an ordinary consumer assume when they saw a product branded as FatBlaster MAX that this was a weight loss product?
If they would, then they would be misled because the product is not listed for that purpose and makes no explicit claim to be such.
The Regulator posits that a reasonable consumer would think that they were purchasing a weight loss product on the basis of the brand-name (and perhaps the flame image) whereas the Applicants posit that no reasonable consumer would make such an assumption.
In Menzies the Tribunal stated that “determining the prospects of success is an important element when considering whether a stay should be granted” and went on to say that where such prospects were limited, no stay should be granted.[19] On the other hand, the threshold for establishing some prospect of success should not be set at an unreasonably high level.
[19] Menzies and Australian securities and Investments Commission [2016] AATA 699 at [27].
By contrast, in Rust-Oleum Deputy President Forgie said “there is a very real question whether the prospects of success are a relevant consideration”.[20] In her decision, the Deputy President relied upon the decision of the Full Federal Court in Madafferi where it said, of a similar provision in the Migration Act 1958 (Cth):
…For the purpose of s 482, however, it is not a relevant question whether there is a serious question to be tried. Under s 482 there is no requirement that there be a serious question for trial. …The only question that arises under s 482 is whether an order is appropriate for the purpose of securing the effectiveness of the hearing and the determination of the appeal.[21]
[20] Rust-Oleum Australia Pty Ltd and Australian Pesticides and Veterinary Medicines Authority [2017] AATA 298 at [34].
[21] Madafferi v Minister for Immigration and Multicultural Affairs [2001] FCA 250 at [27].
Nevertheless, despite these differing approaches, the Tribunal accepts that it has more commonly been the practice of the Tribunal to give some consideration to this issue, at least to the point of refusing a stay when no prospect of success could be identified. Even where some prospect of success may have been identified, this in itself is not determinative of any particular outcome in the Tribunal if other considerations are taken to be accorded greater weight.
Indeed, Bromwich J in Australian International College made it clear that such a consideration was not mandatory given the absence of reference to any such requirement in the statute itself. His Honour stated:
The third suggested (mandatory) relevant consideration of the prospects of success of the AIC on its application for review does, upon a reconsideration of the Tribunal’s written reasons, appear to be a matter that was not, in terms, taken into account in those reasons. However, I fail to see why that is something that was mandatory. It is not a consideration that is provided for in s 41(2), and it is hard to see why such a mandatory relevant consideration would be inferred in the manner described in Minister for Aboriginal Affairs v Peko-Wallsend Ltd (1986) 162 CLR 24 at 39–40; see also Minister for Immigration & Border Protection v BHA17 [2018] FCAFC 68 at [133]–[139]. As already indicated above, the prospects of success of the application for merits review will depend upon the state of affairs at the time of the Tribunal hearing in May 2019, and perhaps beyond. By that time, the state of compliance may well have improved. Conversely, other problems may have emerged.[22]
[22] Australian International College Pty Ltd v Australian Skills Quality Authority [2018] FCA 2097 at [30].
The Tribunal adopts Bromwich J’s position in Australian International College and considers that this is not a mandatory consideration, and therefore will not deal with it in these proceedings.
SECURING AN EFFECTIVE REVIEW
Subsection 41(2) of the AAT Act, as noted above, requires the Tribunal to form an “opinion” about whether a certain course of action (granting a stay) is “desirable”.
This particular term has been the subject of some attention by the Tribunal which has held that:
the word “desirable” connotes a “positive aspiration” and that it is “something worthy of achievement” rather than “merely advisable”.[23]
[23] Liddle and Commissioner of Superannuation [1991] AATA 191 at [50]; Griffiths, Grif-Air Helicopters Pty Ltd and Civil Aviation Authority [1993] AATA 274 at [47].
This, it seems to the Tribunal, requires an applicant for a stay order to demonstrate that there is more than merely the preservation of the status quo to be considered.
However, any such decision has a precedent requirement. Subsection 41(2) of the AAT Act requires that a decision be made “after taking into account the interest of any persons who may be affected by the review”. The word “after” has significance as it requires prior attention to such interests rather than consideration alongside, or at the same time, of the desirability of granting a stay.
It is obvious that both the Applicants and the Respondent are “persons” who may be affected by the review. The Applicants may suffer both financial and reputational loss if the stay order is not granted; the Respondent may be thwarted from carrying out its regulatory duties (as it sees them) if it is.
The term “any person” as it appears in subsection 41(2) of the AAT Act is open-ended. They must have “an interest” in the outcome. Apart from any immediate parties to a stay application, it is up to the Tribunal to determine, logically and upon a sound empirical basis, who may constitute a “person” with an interest.
In this application it has been put to the Tribunal that ordinary members of the public, the successors to the notorious “man on the Clapham omnibus”,[24] in their capacity as purchasers or consumers of the FatBlaster MAX product, have an interest in the outcome.
[24] Or indeed the “Bondi tram” Papatonakis v Australian Telecommunications Commission [1985] HCA 3, [1985] 156 CLR 7 at [36] per Deane J or even the “Bourke street tram”, Pandos and Commonwealth of Australia [1991] AATA 18 at [87].
Despite the absence of any mention of “the public interest” in the specific section of the AAT Act, the Courts have clearly accepted that this can be a relevant consideration,[25] and indeed, the Respondent’s case is built, in part, upon this premise.
[25] Australian Securities and Investments Commission v PTLZ [2008] FCAFC 164 at [42]; Australian Securities and Investments Commission (ASIC) v Administrative Appeals Tribunal [2009] FCAFC 185 at [71].
THE INTERESTS OF THE APPLICANTS
The Applicants asserts that, were a stay not to be granted and its product removed from the shelves, it would suffer financial, commercial and reputational harm.
The Tribunal accepts, on the basis of commercial-in-confidence information put to it[26] that the Applicants would suffer financial loss in terms of lost sales of what appears to be a currently commercially successful product. This is not a matter disputed by the Respondent. The Applicants also state that the FatBlaster MAX product is a brand-leader and hence its presentation and sales boost the sales of other products marketed in the same range. This is not a claim which the Tribunal is in any position to adjudge.
[26] Attachments to Statutory Declaration of Mr John Robertson dated 22 April 2022.
The Applicants assert that commercial losses would derive from its breach of agreements with retailers and its possible contractual obligations to refund them for products which they hold but are no longer able to sell. It also states that the absence of its product in a competitive market would cause market-share loss and gains by competitors which it may not, at some later stage (if their substantive application succeeded and the product were relisted), be able to recoup.
Finally, the Applicants assert that it would suffer reputational damage were it to become known that its product had been taken off the shelves because of some intervention by the Regulator.
These again are assertions which may very well be true but which the Tribunal cannot determine.
The Applicants draw heavily upon these perceived and possible consequences of a stay order not being granted and submits:
“Whether the application for review would be rendered nugatory. These factors set out at paragraph 40 above weigh heavily in favour of a maintenance of the status quo. In effect, the utility of these proceedings will evaporate once a cancellation decision takes effect and is published. Avoiding this is the very purpose to which the stay power is directed.”[27]
[27] Applicant’s written submissions on stay and non-publication (dated 29 April 2022) at [43].
Put shortly, the Applicants contend that the financial and reputational damage done to it were the product to be delisted in the absence of a stay, would mean that it would not be viable for the Applicants to continue proceedings to the point of a merit-based hearing, thus defeating the objective of the AAT Act to preserve matters so that an effective review and determination can take place.
The gravamen of such arguments was addressed by the Tribunal in Technical Education Australia[28] where Senior Member Cameron remarked:
The Applicant contended that if it ultimately succeeded at the final hearing but in the interim suffered “irreparable damage” as a result of revocation of the interim stay order, the application for review would be nugatory. The justification for this contention was that the purpose of the final hearing is to grant relief to a successful applicant and therefore avoid irreparable damage flowing from the decision under review. This contention obviously presupposes that the Applicant would become insolvent in the interim or its reputation so damaged prior to the final hearing that it could not “effectively recover commercially”.
The Tribunal has some difficulty with this approach for several reasons. Firstly, as noted previously, there is just insufficient evidence to conclude that the Applicant would become insolvent or its reputation would be so damaged. Apart from some bare assertions, there is no evidence that enables the Tribunal to reach a view one way or another, as to what if any, reputational damage might be suffered by the Applicant in the event that the stay order was revoked.
…
Overall, given the limited evidence, the Tribunal cannot place much weight on this factor.
[28] Technical Education Australia Pty Ltd and Australian Skills Quality Authority [2018] AATA 3047 at [125]-[128].
Similarly, in addressing the distinction between a decision having a financial impact and actually rendering further proceedings nugatory, I said in Australian Vocational Learning Centre:
The Applicant has not demonstrated to the Tribunal that it would be unable to carry forward its appeal against the reviewable cancellation decision, other than advancing arguments about the immediate financial impact of no stay being granted on its business operations. Indeed the Applicant’s concession that it has sufficient funds available to sustain its business through until mid-March 2019 weighs heavily against taking this point as being of credit to the Applicant’s submission.[29]
[29] Australian Vocational Learning Centre Pty Ltd and Australian Skills Quality Authority [2018] AATA 4725 at [46].
In other words, the test here is not financial embarrassment but rather financial incapacity in taking matters forward.
In terms of whether or not the failure to grant a stay would render any applicant’s case against (in this instance) a regulatory decision nugatory, what must be established is that, the absence of a stay order and hence the execution of the reviewable decision, would have such a fatal effect upon the applicant as to render it impossible for the applicant to even present their case at the substantive (merits) hearing. The onus for establishing this level of fatality falls squarely upon the applicant.
However, the Tribunal has accepted the principle that where an applicant, by virtue of a stay not being granted, is genuinely likely to become insolvent and cease to operate, then that would mean that “the Applications would be rendered nugatory or pointless”[30]. That said, the burden of proof lies heavily upon any applicant to establish such a case. Mere assertion or speculation is not enough.
[30] Australian College of Vocational Studies Pty Ltd and Australian Skills Quality Authority [2018] AATA 1088 at [78].
There is nothing before the Tribunal which would support the proposition that the Applicants would be unable to take proceedings forward due to financial losses incurred as a result of the product in question being delisted.
THE INTERESTS OF THE RESPONDENT
The Respondent both asserts its own interests and challenges the alleged interests of the Applicants.
From its point of view the Respondent is concerned with the question of accuracy in advertising which it has some responsibility to monitor as the regulator.[31] It concedes that there is no issue of safety of the product but states:
“The fact that safety is not presently in issue does make the other objectives in the Act subservient to commercial interests of the applicants at the expense of the other objects of the Act, enumerated both in the ‘objects’ provisions, and in the subsequent provisions of the Act tailored to meeting those objectives (such as advertising conditions).”[32]
[31] John McEwen, A History of Therapeutic Goods Regulation in Australia (Canberra, September 2007) at 15-17; 147-148 and 159-160: < Respondent’s outline of submissions on application for stay and confidentiality order (undated) at [33].
Relevantly, the Objects of the TGA Act (section 4) are (inter alia):
(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;
The courts have accepted that this should be read as encompassing “accuracy in information and advertising related to medications.”[33]
[33] Phytologic Pty Ltd v Secretary, Department of Health [2012] 209 FCR 48 at [47].
Secondly, the Respondent argues that imposition of a stay would impact upon the efficacy of the regulatory mechanism which requires sponsors to give accurate information about a product proposed for listing and the regulator the capacity to delist products where incorrect decisions were made about certification or where there has been non-compliance with regulatory requirements.
Thirdly, the Regulator expresses concern about the Applicants being allowed to “benefit” from any alleged non-compliance by having its produce remaining available for sale while the merits of their application are determined.
Finally, it expresses some concern about the time which might be taken for the matter to proceed to a merits hearing, especially as the Applicants have indicated that they would be seeking to produce “expert evidence” to refute any claims that the use of the term FatBlaster MAX could be taken to imply the use of the product for weight loss purposes,[34] to which, as indicated in oral submissions, the Minister would be likely to respond in kind.
[34] Applicants’ written submissions on stay and non-publication (dated 29 April 2022) at [37]; Statutory Declaration of Ms Teng (dated 28 April 2022) at [19].
In attacking the Applicants’ submissions, the Respondent accepts that the Applicants would suffer some degree of financial loss but disputes the basis and extent of that as outlined in the Applicants’ material.[35]
[35] In particular the details in the Statutory declaration of Mr Anthony Robertson, the Chief Financial Officer of one of the Applicant companies, dated 22 April 2022.
Again, the Tribunal repeats that it is in no position, nor should it try, to evaluate these competing claims.
There are two further points which have been advanced by the Respondent. In the first place it seeks to call into question what it describes as:
“[t]he applicants’ compliance history, and the consequences (or apparent lack thereof). The cancellation of the listings of a product in the FatBlaster range is not unprecedented. Indeed, since 2001, 22 FatBlaster products have had their listing on the Register cancelled.”[36]
[36] Respondent’s outline of submissions on application for stay and confidentiality orders (undated) at [26]. Emphasis in original.
On the face it, that looks unimpressive but, as the Respondent acknowledges, only 3 were cancelled by the Regulator whereas the remainder have been cancelled, for a variety of reasons by the Applicants.[37] The Tribunal draws no adverse conclusions from what is essentially a matter of commercial activity on the Applicants’ part.
[37] See Affidavit of Mr Joshua Smith dated 29 April 2022.
The second perhaps more relevant matter is that following the hearing, and arising from matters discussed during that hearing, the Respondent submitted to the Tribunal a screenshot taken from the internet[38] of an advertisement for a previously sold product of the Applicants which was also marketed as FatBlaster MAX.
[38] Product Review, Naturopathica Fatblaster Max: <>
This shows a box cover which contains the following material:
“naturopathica
FatBlaster
MAX
Ultimate Weight Loss*
Australia’s #1
WEIGHT LOSS
Supplement brand
To help:
·Burn more fat
·Burn more calories
·Boost energy and performance
Aust L 227714
60 TABLETS”.
The colouring and fonts used for FatBlaster MAX are exactly the same on this product as on the product in issue before the Tribunal. However, the picture on the box, instead of the red flame of the current product shows a male and female body; both are tanned and toned. The Tribunal cannot tell from the particular image what the asterisk (*) attached to the word “LOSS” references. The words “ULTIMATE WEIGHT LOSS” in capital letters are set against a yellow strip running across the pack. Clearly the three designated “to help” items are different as is the “Aust L” number.
The Respondent puts forward the argument that this establishes that a product marketed as FatBlaster MAX has previously been sold explicitly as a weight loss product and that this supports its contention that a consumer might assume that the current FatBlaster MAX product is similarly such a product, while the Applicants submit that the two products are clearly different, and a consumer would recognise such a differentiation.
THE PUBLIC INTEREST
The term “any person” as it appears in section 41(2) of the AAT Act is open-ended. They must have “an interest” in the outcome. Apart from any immediate parties to a stay application, it is up to the Tribunal to determine, logically and upon a sound empirical basis, who may constitute a party with an interest.
In Bundy Deputy President Tamberlin stated:
[5] In deciding whether a stay should be granted, the Tribunal should take into account the public interest, and particularly the need to protect consumers of financial services. Other relevant matters include the prospects of success of the application for review; the consequences for the Respondent in carrying out its functions and for those whose interest may be affected by the review.
…
[15] …I give greater weight to the need to protect the consumers and prospective clients of the Applicants by refusal of the stay applications pending determination of the review.[39]
[39] Bundy and Anor and Australian Securities and Investments Commission [2013] AATA 59.
The TGA itself is “consumer focussed”, its entire objective being to provide to the consumer/public access to therapeutic goods which are safe, effective, of high quality and available in a timely fashion. It “does not refer to any consideration of a commercial kind”[40] and it does not mandate that any decision-maker is required to have regard to any such. Indeed, Davies J in Alphapharm went so far as to say of the TGA, “[t]he Act is dominated by public interest concerns”.[41]
[40] Phytologic Pty Limited v Secretary, Department of Health [2012] 209 FCR 48 at [50].
[41] Alphapharm Pty Ltd v Smithkline Beecham (Australia) Pty Ltd and Ors (1994) 32 ALD 71 at 81.
It is also the case that one of the principal factors bringing the various Australian governments together to enact a national system of regulation of therapeutic goods was to ensure some control on the advertising of such products.[42]
[42] John McEwen, A History of Therapeutic Goods Regulation in Australia (Canberra, September 2007) at 15-17; 147-148 and 159-160: <>
In considering public interest matters the Tribunal has given particular attention to protecting consumers where matters of safety have been concerned,[43] even if refusal of a stay application resulted in considerable hardship for an applicant. However, the Tribunal restates the agreement of both parties that matters of safety do not arise in this instance.
[43] Pelling and Secretary, Department of Aviation (1984) 5 ALD 638.
Consumers and their interests in this instance are to be protected against being misled into thinking that a particular therapeutic product is capable of achieving (or helping them achieve) an outcome which they desire but which the product is not listed to (or cannot) achieve. That is a significant public interest, and it is one which the regulator has a responsibility to safeguard through its statutory charge to ensure product “efficacy”.
DISCUSSION AND CONCLUSIONS
The stay order
The Tribunal is persuaded that the Respondent made the decision to delist the FatBlaster MAX product pursuant to its responsibilities under the TGA because it had found, to its satisfaction, a breach of the requirements of paragraph 26A(2)(fba) and various subsections of section 30 of the TGA Act.
The Tribunal has no basis upon which to substitute any alternate view, of its own, on this matter.
The Tribunal accepts that there is a positive public interest in therapeutic goods being advertised and promoted in a way which has no capacity to mislead consumers in any material particular or to cause them to misunderstand the nature and purpose of the product. It is the role of the Respondent as the regulator to ensure that this public interest is protected.
The Tribunal accepts that the Applicants would suffer financial and reputational harm were its product (especially if it is a brand-leader) to be delisted although it is not in a position to quantify the extent of any such losses.
The Tribunal does not accept that the resources of the Applicants are such that they would not be able to pursue a course of action against the Respondent’s decision in the event that their product was delisted. Delisting would not render such proceedings nugatory. It would not impact upon the effectiveness of the hearing and the determination of the application for review.
The timeliness of any merits hearing of the application is very much in the hands of the Applicants in terms of the preparation of their submission.
The desirability of making the stay order is an opinion to be arrived at after consideration of the interests of interested parties. The interest of the Applicants is to secure a stay order. The interests of the Respondent (and, according to its submissions, potentially of consumers or the general public) is for the stay order not to be granted. Both have advanced the grounds for their positions for consideration by the Tribunal.
In all such cases this is a matter of balance which, in this instance favours a conclusion that it is not desirable to grant a stay order, and so the application before the Tribunal will be refused.
Confidentiality orders
It would follow that there would be no logic in denying the stay order and then seeking to conceal the names of the parties or the product in reference to which that order had been sought.
There is no need for the Tribunal to elaborate on the self-evident proposition that the AAT Act is predicated on its hearings being open and accessible to the public.[44] Applicants come before the Tribunal aware of this fact and in the knowledge that, unless there are compelling reasons to the contrary, the public interest requires open hearings and accessible decisions. Commercial applicants are in no more of a privileged or protected position than any member of the community when before the Tribunal.[45]
[44] AAT Act s 35(1).
[45] Australian Securities and Investments Commission (ASIC) v Administrative Appeals Tribunal [2009] FCAFC 185 at [75].
Embarrassment may be an inevitable consequence of determinations in the Tribunal[46] in matters of personal status[47] or commercial status[48]. Neither is protected unless the public interest requires it, and the onus lies upon an applicant if this principle is to be set aside. Proceedings, orders and determinations are not “inherently confidential”.[49]
[46] In another context I have explored this as an issue for the personal privacy of individuals. Chris Puplick, ‘Justice: Now Open to Whom’ (2002) 6(1) Judicial Review 95.
[47] Poidevin and Australian Securities and Investments Commission [2018] AATA 124.
[48] Kukulovski and A Committee convened under section 40-45 of the Insolvency Practice Schedule [2020] AATA 40 at [20]-[23] per DP McCabe.
[49] Daly and Australian Securities and Investments Commission [2020] AATA 1516 at [50] per DP McCabe.
The Tribunal accepts that embarrassment might be caused to the Applicants by the lifting of any confidentiality order, but it has not established that it would be contrary to the public interest for such orders to be lifted.
In the absence of any such public interest having been established it is a logical consequence of the denial of the stay order than the confidentiality order be lifted in respects of the names of the applicants in question.
Different considerations apply in terms of the commercial-in-confidence financial information which was supplied as part of the Tribunal proceedings. The Tribunal notes that it has issued with consent of the parties on 2 May 2022, non-publication orders over such documents. There is no public interest in these being made available and the Tribunal accepts that there would be considerable disadvantage to the Applicants if they were. They should remain confidential.
DECISIONS
The Tribunal makes the following decisions:
(a)the application for a stay order which would continue the existing interim order granted by this Tribunal on 2 May 2022 under subsection 41(2) of the Administrative Appeals Tribunal Act 1975 (Cth) (AAT Act) is refused; and
(b)the application for a confidentiality and non-publication order which would continue the existing interim order granted by this Tribunal on 2 May 2022 under subsection 35(3) of the AAT Act over the Applicants’ names is refused; and
(c)the application for a confidentiality and non-publication order under subsections 35(3) and 35(4) of the AAT Act in respect of the name of the product and the fact that a decision has been made in relation to that product, or any product of the Applicants is refused.
The Tribunal also directs pursuant to subsection 35(4) of the Administrative Appeals Tribunal Act 1975 (Cth), that on the ground that the order is necessary to prevent prejudice to the proper administration of justice, the information contained in Confidential Exhibit AJR-3, Confidential Exhibit AJR-4 and Confidential Exhibit AJR-5 to the Statutory Declaration of Anthony John Robertson declared on 22 April 2022 must not be published or otherwise disclosed to any person other than the parties or their legal representatives.
I certify that the preceding 100 (one hundred) paragraphs are a true copy of the reasons for the decision herein of Chris Puplick AM, Senior Member
....................................[sgd]....................................
Associate
Dated: 13 May 2022
Date(s) of hearing: 2 May 2022 Counsel for the Applicant: Mr S Lloyd SC; Ms N Wootton Solicitors for the Applicant: Ms M Still, Clayton Utz; Ms F Teng, Clayton Utz Counsel for the Respondent: Mr N Wood SC; Mr C Viney Solicitors for the Respondent: Mr J Smith, Department of Health; Ms J Lau, Department of Health
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