TFS Manufacturing Pty Limited and Minister for Health

[2017] AATA 122

TFS Manufacturing Pty Limited and Minister for Health [2017] AATA 122 (1 February 2017)

Division:GENERAL DIVISION

File Number:          2015/1447

Re:TFS Manufacturing Pty Limited

APPLICANT

AndMinister for Health

RESPONDENT

DECISION

Tribunal:Deputy President K Bean

Date:1 February 2017

Place:Adelaide

1.A confidentiality order should be made, pursuant to subs 35(4) of the Administrative Appeals Tribunal Act 1975, preventing disclosure of the identities of the internal evaluators, including to the applicant.

2.The parties are to be given a further opportunity to be heard as to the precise terms of the order.

................. [Sgd] .....................................

Deputy President K Bean

CATCHWORDS

PRACTICE AND PROCEDURE – Application for confidentiality order with respect to documents contained in section 37 T-Documents – Order sought to prohibit disclosure of identities of internal evaluators – Relevance of identity of internal evaluators – Whether prejudice or disadvantage to applicant if order made – Confidentiality order made.

LEGISLATION

Administrative Appeals Tribunal Act 1975, ss 35 and 37

Therapeutic Goods (Medical Devices) Regulations 2002

REASONS FOR DECISION

Deputy President K Bean

1 February 2017

1. The substantive application in this matter concerns a request by the applicant (TFS) for review of a decision made by the respondent on 27 February 2015.  That decision affirmed an earlier decision to cancel TFS’s entry for a device described as “prosthesis, incontinence” ARTG 132657 (the TFS Device) from the Australian Register of Therapeutic Goods (the Register).

2. That decision was based, in part, on a conclusion that TFS had refused or failed to comply with an applicable condition that at all times while the device was included on the Register, TFS have available sufficient information to satisfactorily establish compliance with certain Essential Principles listed in the Therapeutic Goods (Medical Devices) Regulations 2002.  The Essential Principles of most relevance are Essential Principle 14 relating to clinical evidence, Essential Principle 6 relating to whether the benefits of medical devices outweigh any undesirable effects, and Essential Principle 2 relating to design and construction of medical devices so as to conform with the safety principles.

3. It is in this context that under cover of letter dated 23 April 2015, the respondent filed and served documents under s 37(1) of the Administrative Appeals Tribunal Act 1975 (AAT Act) (the T-Documents).

4. At the time of filing the T-documents, the respondent sought an order under subs 35(2)(c) of the AAT Act (as it then was) prohibiting the disclosure of two documents over which legal professional privilege was claimed to TFS. The respondent also made redactions to a number of other documents included in the T-documents[1] on the basis that parts of those documents contained information that was not relevant to the decision under review. In the event the Tribunal considered this information was relevant, the respondent also sought an order under subs 35(2)(c) with respect to the redacted information. The redactions were made to two categories of documents:

   (a)Documents that contained information that could identify the respondent’s internal evaluators who made assessments of TFS’s submission; and

   (b)Documents that contained information that could identify adverse event reporters who made reports to the respondent.[2]

   [1]    Documents: T13, T14, T27, T28, T42, T52, T53, T53-1, T54, T56, T58, T61, T61-1, T61-2, T62, T62-1, T63, T64, T64-11, T66, T67, T68, T69, T70, T72, T73, T75, T76, T78, T79, T81, T82, T84.

   [2]     Respondent’s Outline of Submissions dated 15 June 2015, [18].

5. On 18 May 2015, an initial hearing of the respondent’s application for a confidentiality order took place. At that hearing, I made orders under subs 35(2)(c) of the AAT Act prohibiting the disclosure of the two documents which the respondent claimed were protected by legal professional privilege, namely T43 and T44. I also made directions requiring an exchange of further material between the parties, and that the matter be listed for a further interlocutory hearing to address the confidentiality issue. In the event, a hiatus ensued while the parties had discussions, and the matter was not listed for a further interlocutory hearing on the confidentiality application until 6 June 2016.

6. Just before the commencement of that hearing, agreement was reached with respect to the adverse event reports, and on 8 August 2016 I made the following Directions with respect to those:

   UPON NOTING THAT:

   (i)the respondent does not propose to rely upon any Device Incident Reports submitted by users; and

   (ii)both parties are agreed that such Reports are not relevant to the Tribunal’s review of the reviewable decision.

   THE TRIBUNAL, with the consent of both parties, DIRECTS that:

   1.The following documents shall be excised from the T-documents prior to reception of the T-documents into evidence at the hearing: T52 – T84 inclusive; and

   2.At the hearing, prior to reception of the T-documents into evidence, the documents set out in paragraph 1. above shall be replaced with a blank page annotated with the T-document numbers, page numbers, and the words ‘Removed by direction of the Tribunal’.

7. As at the date of the hearing on 6 June 2016, it was hoped that agreement may also be reached with respect to the internal evaluators’ identities.  However, that did not transpire, and the matter was ultimately listed for a further interlocutory hearing on 19 October 2016.  TFS has maintained its position that the identity of the internal evaluators is relevant in the matter before the Tribunal and that it would suffer prejudice in the event the identities were not disclosed.  The respondent maintains its position that:

   (a)The identity of the internal evaluators is not relevant;

   (b)In any event, even if those identities are relevant, the Tribunal should exercise its discretion to make an order pursuant to s 35 of the AAT Act protecting those identities from disclosure; and

   (c)The identities of the internal evaluators are protected in any event by public interest immunity.

   STATUTORY FRAMEWORK AND ISSUES

8. There are a number of provisions of the AAT Act which are potentially relevant to determining the respondent’s application. The most relevant provisions are ss 35 and 37, each of which relevantly provide as follows:

   35  Public hearings and orders for private hearings, non‑publication and non‑disclosure

   …

   Orders for non‑publication or non‑disclosure

   (3)The Tribunal may, by order, give directions prohibiting or restricting the publication or other disclosure of:

   (a)information tending to reveal the identity of:

   (i)a party to or witness in a proceeding before the Tribunal; or

   (ii)any person related to or otherwise associated with any party to or witness in a proceeding before the Tribunal; or

   (b)information otherwise concerning a person referred to in paragraph (a).

   (4)The Tribunal may, by order, give directions prohibiting or restricting the publication or other disclosure, including to some or all of the parties, of information that:

   (a)relates to a proceeding; and

   (b)is any of the following:

   (i)information that comprises evidence or information about evidence;

   (ii)information lodged with or otherwise given to the Tribunal.

   (5)In considering whether to give directions under subsection (2), (3) or (4), the Tribunal is to take as the basis of its consideration the principle that it is desirable:

   (a)that hearings of proceedings before the Tribunal should be held in public; and

   (b)that evidence given before the Tribunal and the contents of documents received in evidence by the Tribunal should be made available to the public and to all the parties; and

   (c)that the contents of documents lodged with the Tribunal should be made available to all the parties.

   However (and without being required to seek the views of the parties), the Tribunal is to pay due regard to any reasons in favour of giving such a direction, including, for the purposes of subsection (3) or (4), the confidential nature (if applicable) of the information.

   …

   37  Lodging of material documents with Tribunal

   …

   Decision‑maker must lodge material documents

   (1)Subject to this section, a person who has made a decision that is the subject of an application for review (other than second review) by the Tribunal must, within 28 days after receiving notice of the application (or within such further period as the Tribunal allows), lodge with the Tribunal a copy of:

   (a)a statement setting out the findings on material questions of fact, referring to the evidence or other material on which those findings were based and giving the reasons for the decision; and

   (b)  subject to any directions given under section 18B, every other document that is in the person’s possession or under the person’s control and is relevant to the review of the decision by the Tribunal.

   …

   Statement of reasons and relevant documents to be given to other parties

   (1AE)A person who is required under subsection (1), (1AAB) or (1AB) to lodge a copy of a statement or document with the Tribunal within a particular period must, unless the Tribunal directs otherwise, also give a copy of the statement or document to each other party to the proceeding, within the same period.

   When document not required to be lodged

   (1AF)If:

   (a)a person who has made a decision that is the subject of an application for a review by the Tribunal would, apart from this subsection, be required under paragraph (1)(b) or subsection (1AAB) to lodge a copy of a document with the Tribunal in respect of the application; and

   (b)within the period applicable under subsection (1) the person:

   (i)applies to the Tribunal for a direction under subsection 35(3) or (4) in relation to the document and lodges with the Tribunal, together with the application for the direction, a copy of the document; and

   (ii)gives a copy of the application for the direction to each party to the application for review;

   the person is not required to comply with paragraph (1)(b) or subsection (1AAB) in relation to the document unless and until the Tribunal, after hearing the application for the direction, directs the person to do so.

   …

   Privilege and public interest

   (3)This section has effect notwithstanding any rule of law relating to privilege or the public interest in relation to the production of documents.

9. Having regard to the terms of these provisions and the contentions of the parties, the issues potentially arising for my determination are as follows:

   (a)Whether the identities of the internal evaluators are relevant to the proceedings;

   (b)Whether an order should be made under s 35 of the AAT Act protecting the identities of the internal evaluators;

   (c)Whether common law public interest immunity applies in Tribunal proceedings; and

   (d)If so, whether the identities of the internal evaluators are protected or partially protected by public interest immunity.

   ARE THE IDENTITIES OF THE INTERNAL EVALUATORS RELEVANT TO THE PROCEEDINGS?

10. I note the respondent has maintained its original submission that the names of the internal evaluators are not relevant.[3]  However, at the initial hearing on 6 June 2016, Mr Howe QC, who appeared for the respondent, acknowledged that there was a distinction to be drawn between the adverse incident reports, which were not relevant, and the names of the internal evaluators.  He acknowledged that for the names of the internal evaluators to be removed from the T-documents would have “an artificiality about it”[4] because if they were removed “the decisional making history of the matter would make less sense … .”[5]

    [3] Respondent’s submissions on the effect of section 37(3) dated 16 November 2016, [13].

    [4]     Transcript, 6 June 2016, p 7.

    [5]     Ibid.

11. I consider that acknowledgement to have been properly made and in my view, the identity of the authors of evaluation reports which have been relied upon in making the decision under review are sufficiently relevant to be caught by the obligation imposed by s 37. Accordingly, in my view, those names must be disclosed to the applicant unless they are protected by a confidentiality order under s 35, or by public interest immunity.

    SHOULD AN ORDER BE MADE UNDER s 35?

12. The respondent invited me to first consider what order I was prepared to make under s 35 before considering the possible application of public interest immunity. The respondent pointed out that it would only be necessary for me to consider the public interest immunity claim in the event I was not minded to make an order consistent with that sought by the respondent pursuant to s 35 of the AAT Act. Given the complexity of the issues which arise in relation to the application of public interest immunity in Tribunal proceedings, I have decided to adopt that course.

13. In support of his application for a s 35 order, the respondent relies upon an affidavit of Mr Lawrence Francis Kelly, First Assistant Secretary in the Therapeutic Goods Administration (TGA), dated 15 June 2015. In that affidavit he relevantly states:

    It is my view and my experience that disclosing the identities of individuals involved in preparing evaluation reports could have a prejudicial impact on the operations of the TGA.

    The disclosure of evaluators’ names may result in undue influence being applied to persons undertaking assessments; accordingly, their anonymity is considered an important aspect of their independence.

    I am aware that in the past TGA officers have been contacted and harassed by sponsors.

    It has been, and remains, the TGA’s practice to keep evaluators’ names confidential.  This is considered to be particularly important where the therapeutic goods being assessed are highly controversial or contentious (such as abortifacients or HIV treatments).

    The practice of keeping evaluators’ names confidential has extended beyond evaluation of highly controversial or contentious products to evaluators of all products.  This is because the pool of evaluators at the TGA is limited, and if names are disclosed in particular cases it may be possible to determine who is (or was) involved in assessing a highly controversial therapeutic goods.

    Further, I believe disclosing evaluators’ personal information could be detrimental to the TGA’s operations as it might create difficulties for the recruitment and retention of qualified evaluators at the TGA, thereby impeding performance of the TGA’s statutory functions in the public interest.[6]

    [6] Affidavit of Lawrence Francis Kelly dated 15 June 2015, [41] - [46].

14. There are several things worth noting about these statements.  Firstly, it is notable that the harm referred to is acknowledged to be no more than a possibility, denoted by the use of words such as ‘could’ and ‘may’.  Mr Kelly does not state anywhere in his affidavit that, if the internal evaluators’ names were disclosed, he believes this would be likely to lead to harm.  Mr Kelly also acknowledges that it is more important to keep internal evaluators’ names confidential where the therapeutic goods being assessed are highly controversial or contentious—which is not the case here.  Further, the potential harm referred to by Mr Kelly appears to be largely predicated on the prospect of the internal evaluators’ names entering the public domain.  The negative consequences referred to by Mr Kelly are also in some cases highly contingent—for example, he refers to the possibility that if an evaluator’s name was disclosed in one matter, their identity may become known to other sponsors and other sponsors may then seek to contact that evaluator if they formed the belief that the particular evaluator was or may also be involved in evaluation of the sponsor’s device.

15. It is also not entirely clear from Mr Kelly’s affidavit why disclosure of the internal evaluators’ identities in one particular matter in the context of merits review proceedings would create “difficulties for the recruitment and retention of qualified evaluators at the TGA”, nor is it immediately apparent as to why disclosure of internal evaluators’ names in the context of merits review proceedings long after they have completed their reports “may result in undue influence being applied to persons undertaking assessments”—unless it is accepted that there is a risk of sponsors contacting internal evaluators at the TGA with a view to influencing them, without knowing whether the evaluator is involved in assessing their particular product or device.  Mr Kelly also does not expressly address the possibility that the names of the internal evaluators could be disclosed to TFS and TFS’s lawyers only, but otherwise remain protected by a confidentiality order.  It is difficult to infer from his affidavit what the consequences of such a limited disclosure may be, although I am prepared to accept, based on his affidavit, that even a limited disclosure of that kind carries some risk of wider disclosure and may have some negative consequence of the kind he has identified.

16. Nevertheless, having made those observations, I accept that Mr Kelly’s affidavit establishes what might be called a ‘prima face’ case for protection of the internal evaluators’ identities under s 35. It satisfies me that there are legitimate concerns surrounding the identities of the internal evaluators, and that, notwithstanding the matters referred to in subs 35(5), it would be preferable in the public interest for their identities not to be disclosed, including to TFS, unless this would in some way prejudice or disadvantage TFS. In other words, I consider that Mr Kelly’s affidavit provides sufficient justification for a confidentiality order to be made, which must be weighed against the countervailing considerations advanced by TFS.

17. As to TFS’s reasons for opposing the order, TFS accepts that, in the event, the material assessed by the internal evaluators has been overtaken by a large volume of additional material now relied upon by TFS, which has been the subject of evaluation by a number of experts retained by the respondent.  Nevertheless, TFS points to inconsistencies between the approach taken by the internal evaluators and that taken by the experts now relied upon by the respondent, and points to potential forensic advantages which may accrue to it through knowing the names of the internal evaluators.  As I understand the position, if TFS knew the names of the internal evaluators it may seek to do one or more of the following:

    (a)Contact the internal evaluators to discuss their reports, opinions and perhaps their qualifications/experience;

    (b)Conduct research as to the internal evaluators’ qualifications/experience/standing;

    (c)In the event the internal evaluators are of sufficient standing to justify it, potentially put to the respondent’s experts under cross-examination propositions based upon inconsistencies between the approach taken by the internal evaluators on the one hand, and the respondent’s experts on the other, particularly relating to the experts’ reliance on the Cochrane standard and randomised controlled trials; and

    (d)Seek to have one or more of the internal evaluators give evidence at the hearing, with a view to illustrating inconsistencies of approach between the internal evaluators and the respondent’s experts.

18. However, as Mr Howe pointed out and Mr Harris QC, who appeared for TFS, ultimately conceded at the hearing on 19 October 2016, it is unlikely to be necessary for TFS to know the identity of the internal evaluators in order to require them to give oral evidence.  Mr Howe effectively indicated that should the situation arise, he expected the solicitors acting for the respondent would be instructed to accept service of any summons to give evidence directed to an internal evaluator, and arrangements could potentially be made for them to give evidence by telephone in such a way that their identity was not revealed.

1. In addition, after the hearing on 19 October 2016, the respondent provided to TFS and the Tribunal an anonymised and abbreviated version of the education and professional qualifications of each of the relevant internal evaluators, giving an indication of their qualifications, experience and professional standing.

2. On analysis, therefore, not knowing the identities of the internal evaluators is only likely to act as an impediment to the following potential actions identified by TFS:

   (a)Contacting the internal evaluators to discuss their opinions;

   (b)Ascertaining all details of their qualifications/experience/standing; and

   (c)Putting propositions to the respondent’s experts based on the above.

3. In order to determine the degree of prejudice likely to be suffered by TFS if it is not able to do these things, it is helpful to consider the extent of the asserted inconsistency between the internal evaluators’ reports and those of the respondent’s current experts.  As I have explained, it is that asserted inconsistency upon which TFS relies in seeking to potentially engage in the actions identified above.

4. It is important to point out that, in general terms, there is no inconsistency between the opinions of the internal evaluators and the respondent’s current experts—all of them have concluded on the basis of the material before them, that the TFS device did not meet the relevant Essential Principles.  However, TFS assert inconsistencies of approach which may assist its case.  In particular, TFS points to the fact that the respondent’s experts have referred to the absence of randomised controlled trials, or a literature review to the “Cochrane standard”.  TFS has also pointed to the fact that the internal evaluators, although reaching the same conclusion, did not refer to randomised controlled trials or the Cochrane standard.

5. I note that the internal evaluators’ reports are at T14, T45.3 and T45.4[7] respectively.  Internal evaluators’ names have also been redacted from other pages of the T-documents (at T13, T27, T28 and T42).  However, those pages contain little of substance and it is the identities of the internal evaluators who conducted substantive assessments and provided reports which are of interest to TFS.

   [7]     An unsigned version of this report also appears at T30.3.

6. With respect to the first relevant evaluation report (at T14), I note that this is a short advice dated 22 April 2010 directed to “the adequacy of the training and the instructions for use provided for this device”.  I have not been able to identify any relevant inconsistency between this advice and the reports of the respondent’s experts of the kind identified by TFS.  At present, therefore, it is not apparent to me that knowing the identity of the author of the document at T14/82 would assist TFS.

7. Turning to the assessment report at T45.3, I note that this addresses TFS’s literature search protocol and report then before the internal evaluator.  The internal evaluator makes a number of criticisms of the literature search protocol and report, concluding that only one data base was used to complete the literature search, the date of the literature search was not provided, the range of publication dates included in the search was not provided, and no inclusion or exclusion criteria were listed.[8]  The internal evaluator observes:

   Due to the deficits identified above, the report does not provide sufficient detail to enable the search to be reproduced. Furthermore, the information presented does not establish confidence that the search performed was unbiased and represents the current published literature. This has negatively impacted the quality of the literature included in the critical analysis.[9]

   [8]     T45/622.

   [9]     T43.2/622.

8. With respect to critical analysis of the literature, the internal evaluator concluded:

   Overall, the Clinical Evidence Report does not present sufficient objective critical analysis of the literature. The authors have completed a brief critical analysis of only one study that highlighted several complications with the Tissue Fixation System (Atherton et al 2011). A critical analysis of the remaining 25 studies referenced has not been presented.[10]

   [10]    Ibid, 623.

9. In relation to Essential Principle 14, the internal evaluator concluded:

   In light of the deficits identified in the literature search strategy, lack of current published literature, lack of objective critical analysis of studies selected, insufficient synthesis of safety data, in addition to the insufficient discussion and management of clinical risks, the Sponsor has not presented adequate evidence to support the conclusion made above.[11]

   [11]    T45.3/624.

10. Turning to the assessment report at T45.4, this contains an assessment of additional information provided by TFS including a study presenting the results of a “single blinded randomised controlled trial comparing the efficacy of a transobturated tape (TOT) operation with an adjustable mini-sling (TFS) for the treatment of stress urinary incontinence.”[12]

    [12]    T45.4/631.

11. In summarising their conclusions about this information, the internal evaluator states:

    The sponsor has submitted several journal articles with no supporting literature review or documented search strategy. No full clinical study reports have been provided for the device in question. A critical review of the journal articles presented authored by a suitable clinical expert has not been submitted. … The studies vary in quality and most rely on subjective measures of symptomatic improvement.[13]

    [13]    T45.4/637.

12. Comparing the internal evaluators’ reports with the reports of the respondent’s current experts reveals the following.

13. Associate Professor David Lubowski, a Colorectal Surgeon, expresses the view that:

    … [p]roperly conducted prospective randomised trials are required to show that the device is effective and safe when treating faecal incontinence or obstructed defaecation.[14]

    [14]    Report of Associate Professor D Lubowski dated 18 July 2016, p 9.

14. Dr Alexander Stevenson, a General Practitioner and Clinical Lecturer in General Practice at the Australian National University, expresses the view that:

    The gold standard methodology for conducting a systematic review are the methods outlined in the Cochrane … handbook for systematic reviews of interventions.[15]

    He also observes that:

    In medical research, study designs can be ranked according to methodological quality eg: Randomised trials as (sic) more likely to give an accurate reflection of the truth than non-randomised comparative clinical trials or cohort studies.[16]

    [15] Report of Dr A Stevenson dated 14 July 2016, at [10].

    [16] At [41].

15. In his report, Dr Stevenson was critical of the fact that the TFS “Clinical Efficacy and Safety Report” (CESR) used “only one data base.”[17] He was also critical of the search terms used,[18] and the fact that the search was “limited to English language studies” and was only “conducted from 2005-2015”.[19]

    [17] At [22].

    [18] At [28].

    [19]    At [30] and [32].

16. In her report, Dr Elizabeth Gallagher, a Specialist Obstetrician and Gynaecologist, refers to the same randomised controlled trial identified by the internal evaluator who authored T45.4:

    There is some clinical data presented in the Clinical Efficacy and Safety Report to support the use of the TFS specifically, for the treatment of USI [urinary stress incontinence]. There is one randomised controlled trial of good quality presenting 3 and 5 year data comparing the TFS and Trans Obturator Tape (Sivaslioglu 2010 and 2012). This is limited by the small number of patients, 40 in each arm but the 2 slings compare favourably with a low complication rate for both slings. The results include both subjective and objective assessments of cure. There are two clinical studies from Japan … 1 and 2 year results for 54 women, again giving good cure rates of around 90% with low complication rates. While these studies show promising results, they are limited by the small patient numbers, and the lack of similar supporting studies.[20]

    [20] Dr Elizabeth Gallagher dated 1 August 2016, at [72].

17. Like the internal evaluator, she concludes that the clinical studies undertaken to date are insufficient and do not cover all indications claimed.  She states:

    The clinical evidence to support the use of the TFS to treat POP is very poor.[21] There are no randomised controlled trials using the TFS for the treatment of POP.[22] The evidence presented by the Applicant consists of editorial letters, preliminary studies, or descriptions of the surgical techniques for each ligament followed by a descriptive report on results and complications. There is not enough clinical evidence contained in these studies to be reproducible, or to be confident in the way results and complications have been collected and assessed.  Long-term data is lacking with these poor quality studies with only results of a small number of patients up to three years reported.[23]

    [21]    POP being ‘pelvic organ prolapse’.

    [22] At [73].

    [23]    Ibid.

18. She continues:

    Therefore I do not believe that the Clinical Efficacy Report for the use of the TFS for the treatment of POP complies with Essential Principle 14, due to a lack of clinical evidence supporting its use in clinical practice.[24]

    [24] At [74].

19. Significantly, Dr Gallagher refers to a “Cochrane Review” of “Mini-slings” having been undertaken, namely “The second Cochrane Review of Mini-slings (Nambia 2014)”, which

    … [c]oncluded that “there is currently not enough evidence on single incision slings (excluding TVT-Secure which was inferior) compared with the retro pubic or transobturator slings to allow reliable comparison. It is apparent that a significant difference in fixation mechanisms may influence outcomes”.

    And:

    …“[w]hen one single-incision sling was compared to another, evidence was insufficient to suggest a significant difference between any of the slings in any of the comparisons made”.[25]

    [25] At [27].

20. She noted:

    Despite the findings from the Cochrane review above, and the lack of evidence presented, the Clinical Efficacy and Safety Report concluded that the “TFS easily matches results of other minislings and in many cases is found to be superior” (Page 1087) This conclusion is not supported by the evidence presented.[26]

    [26]    Ibid.

21. She added later:

    The Cochrane review of Minislings did not find enough evidence to support the Minisling over TVT or TOT. Therefore, while the TFS may have similar or superior results to similar products in the management of GSI, with the low number of complications, the body of evidence supplied is too small to form a valid conclusion in favour of the TFS for use in GSI.[27]

    [27] At [34].

22. She continued:

    The conclusion that the “literature search provides strong evidence that the use of the TFS for the treatment of vaginal prolapse offers significant benefits for the patient” is not supported by the evidence presented. I have concerns that after more than 10 years on the market in Australia, and over 15707 devices sold worldwide, with continued sales of approximately 600 per annum the evidence to support this device for the use of POP does not include any randomised controlled trials comparing either a vaginal mesh product or native tissue repair.[28]

    [28] At [35].

23. Having compared aspects of the internal evaluators’ reports on the one hand and the respondent’s current experts on the other, I am not persuaded that there are meaningful inconsistencies in the approaches which have been taken, bearing in mind the two sets of experts assessed different bodies of material and at different stages in the review.

24. The material produced by the respondent’s current experts suggests that prospective randomised controlled trials are the “gold standard” for clinical trials and the “Cochrane standard” is the gold standard for literature reviews.

25. All of the respondent’s experts who have been asked to address the issue have identified what they regard as significant shortcomings in the literature reviews provided by TFS and, although Dr Stevenson indicated that he was assessing the literature review by reference to the Cochrane standard, none of them has suggested that a literature review to the Cochrane standard is essential in order to comply with the Essential Principles.  Indeed, Dr Gallagher referred to a Cochrane Review having been undertaken, albeit not by TFS.  Her criticism was not so much with respect to the absence of a Cochrane Review, but the conclusions of the Cochrane Review she referred to.

26. With respect to randomised controlled trials, one of the current experts and one of the internal evaluators have acknowledged the existence of one relevant randomised controlled trial relating to incontinence.  However, both the respondent’s experts and the internal evaluator concluded this was insufficient to meet the Essential Principle.

27. Dr Gallagher has noted there are no randomised controlled trials using the TFS Device for the treatment of POP, and that there is accordingly a lack of clinical evidence to support use of the TFS Device for the treatment of POP, being a condition within her area of expertise.  Associate Professor Lubowski has also expressed the opinion that properly conducted prospective randomised controlled trials are required to show that the device is effective and safe when treating faecal incontinence and obstructive defecation, being conditions within his area of expertise.

28. I see no meaningful inconsistency between those opinions and the opinions expressed by the internal evaluators to the effect that:

    ·there is a need for “full clinical study reports for the device in question used in the indications claimed, or reports for a similar device with reasoned argument as to why the safety and performance of that device may be extrapolated to the device under assessment …”[29]; and

    ·the literature search then relied on by TFS was deficient for reasons including that it was not reproducible and that no inclusion or exclusion criteria were provided.

    [29]    T45.3/637.

29. Regardless of the precise qualifications, experience and/or standing of the internal evaluators, based on a comparison between the opinions of the respondent’s current experts and the opinions expressed by the internal evaluators, in my view there is little reason to expect that the respondent’s experts would modify or resile from any aspect of their opinions in response to being questioned about the internal evaluators’ reports and/or opinions, by reason of the standing, education or experience of the internal evaluator.  I also consider it relatively unlikely that the respondent’s experts would modify or resile from any aspect of their opinions in response to the content of the evaluation reports, although I note that it will be open to TFS to put propositions to them in cross-examination based on those reports.  I acknowledge that, without knowing the identity of the internal evaluators, it will not be possible for TFS to approach the internal evaluators with a view to assessing whether they should be summonsed to give evidence.  However, summonsing the internal evaluators would be a highly unusual course for TFS to adopt given the conclusions reached in their reports, and the only basis upon which it is asserted to be a possibility is the claimed inconsistency.  As I have explained, I do not accept that there is any meaningful inconsistency of approach between the internal evaluators and the respondent’s experts.

30. For completeness, in the absence of any meaningful inconsistency, I also do not accept that knowing the precise qualifications, experience and/or standing of the internal evaluators will be of any relevance to the Tribunal’s consideration of their opinions, noting that those opinions have been overtaken in any event and are not relied upon by the respondent.

31. In the event, therefore, I am not persuaded that the justification put forward by TFS for requiring access to the identities of the internal evaluators has been established.  I accept that if there had been prejudice or disadvantage to TFS in not knowing the names of the internal evaluators, this may have outweighed the reasons put forward by the respondent for requesting that the internal evaluators’ names not be disclosed.  It may well have dictated an outcome whereby the names of the internal evaluators, or some of them, were disclosed, at least to TFS and TFS’s lawyers, if not more widely.  However, in the absence of any prejudice or disadvantage to TFS in not knowing the names of the internal evaluators, I am persuaded on balance that I should make a confidentiality order protecting the identities of the internal evaluators.

32. In light of that conclusion, it is unnecessary for me to address the issue of the potential application of public interest immunity, as the protection afforded by the s 35 order will be co-extensive with that which would apply if the public interest immunity claim were upheld.

33. At present, I am minded to make an order in the following terms:

    The Tribunal directs, pursuant to subs 35(4)[30] of the AAT Act, that until further order the publication or other disclosure of the following information be restricted as follows:

    (a)The following documents are not to be disclosed to any person other than the respondent and his legal representatives, and members and staff of the Tribunal:

    (i)     the unredacted versions of T13, T14, T30.3, T45.3, T45.4, T27, T28 and T42.

    [30] This is the equivalent provision to the old subs 35(2)(c), following amendments made to the AAT Act in 2015.

34. However, there is a Telephone Directions Hearing listed in this matter on Friday, 3 February 2016 and I propose to give the parties a further opportunity to be heard as to the precise terms of the order.

    DECISION

35. A confidentiality order should be made, pursuant to subs 35(4) of the AAT Act, preventing disclosure of the identities of the internal evaluators, including to the applicant.

36. The parties are to be given a further opportunity to be heard as to the precise terms of the order.

I certify that the preceding 54 (fifty-four) paragraphs are a true copy of the reasons for the decision herein of Deputy President K Bean

........... [Sgd] .....................................

Administrative Assistant

Dated: 1 February 2017

Dates of hearing:	6 June 2016 and 19 October 2016
Counsel for the Applicant:	Mr A Harris QC
Solicitors for the Applicant:	Mr A Rosser Cosoff Cudmore Knox Lawyers
Counsel for the Respondent:	Mr T Howe QC
Solicitors for the Respondent:	Mr K Teoh Therapeutic Goods Administration