TFS Manufacturing Pty Ltd and Minister for Health

TFS Manufacturing Pty Ltd and Minister for Health [2018] AATA 4456 (29 November 2018)
Division:GENERAL DIVISION
File Number: 2015/1447
Re:TFS Manufacturing Pty Ltd
APPLICANT

Minister for HealthAnd
RESPONDENT

DECISION
Tribunal:Justice D G Thomas, President
Deputy President S A Forgie
Senior Member A Poljak

Date:29 November 2018
Place:Adelaide

The Tribunal decides to:
affirm the decision dated 1 October 2014 of the Secretary of the Department of Health to cancel the entry of the prosthesis, incontinence ARTG 132657 in the Australian Register of Therapeutic Goods under s 41GN(1)(b) of the Therapeutic Goods Act 1989, as affirmed by a delegate of the Minister on 27 February 2015.
.............................[Sgd]...........................................
Justice D G Thomas, President
Catchwords
THERAPEUTIC GOODS – cancellation of entry on Australian Register of Therapeutic Goods – whether failure to comply with condition of entry – whether had sufficient information to substantiate compliance with essential principles 2, 6 and 14 – whether discretion to cancel entry should have been exercised – decision affirmed
Legislation
Therapeutic Goods Act 1989 (Cth); ss 4(1)(a); 41CA; 41DA; 41FD; 41FD(d); 41FD(e) 41FDB; 41FDB(2); 41FE; 41FF; 41FH; 41FN; 41FN(3); 41FN(3)(a); 41FN(3)(a)(i); 41FN(3)(a)(ii); 41FP; 41GA; 41GC(3); 41GD(1); 41GN; 41GN(1)(b); 41GN(2); 41JA(1) and 60
Therapeutic Goods (Medical Devices) Regulations 2002 (Cth); rr 2.1; 3.11; 3.11(1); 3.11(1)(c); 3.11(2); 3.4(3); 3.4(4) and 4
Schedule 1, cll 1, 2, 3 6, 13.4 and 14; Schedule 3, cll 8.1, 8.3, 8.3(1)(b); 8.4 8.5; 8.5(a)(i); 8.5(a)(ii); 8.5(a)(iii); 8.5(b) and 8.6
Cases
Drake v Minister for Immigration and Ethnic Affairs (1979) 2 ALD 60
Re Drakeand Minister for Immigration and Ethnic Affairs (No. 2) (1979) 2 ALD 634
TFS Manufacturing Pty Ltd v Minister for Health [2017] AATA 2786
Secondary Materials
Australian Regulatory Guidelines for Medical Devices
Chambers 21^st Century Dictionary
Tech Coloproctol (2013) 17(4)
REASONS FOR DECISION
Justice D G Thomas, President
Deputy President S A Forgie
Senior Member A Poljak
29 November 2018

TFS Manufacturing Pty Limited (“TFS”), the applicant, is the manufacturer of an urogynaecological mesh medical device; registered as “Prosthesis, incontinence” ARTG 132657 (“the Device”) in the Australian Register of Therapeutic Goods (“the Register”) between 30 October 2006 and 5 November 2014. The Device is an Australian designed surgical implant, in the form of a polypropylene tape and anchors. The intended purpose of the Device as described in the Register is “…to cure female urinary or faecal incontinence and vaginal prolapse”.[1]
[1]Exhibit A3, Affidavit of Paul Andrew Zadow, Attachment: PAZ 1, Conformity Assessment Certificate and ARTG Certificate, p. 17.
On 1 October 2014, a delegate of the Secretary of the Department of Health (“the Secretary”) decided to cancel the entry of the Device in the Register pursuant to s 41GN(1)(b) of the Therapeutic Goods Act 1989 (Cth) (“the Act”) (“the cancellation decision”).[2] The cancellation decision took effect and the Device was removed from the Register on 5 November 2014.
[2]Exhibit R7, T Documents, vol. 2, T45, the cancellation decision, dated 1 October 2014, pp. 602 – 608.
In these proceedings, TFS seeks review of a decision made by a delegate of the respondent, pursuant to s 60 of the Act, on 27 February 2015, affirming the cancellation decision (“the reviewable decision”).[3] The reviewable decision was based, in part, on a conclusion that TFS had refused or failed to comply with an applicable condition, namely, that at all times while the device was included in the Register, TFS have sufficient information available to satisfactorily establish compliance with the essential principles (“the essential principles”). The essential principles are requirements set out in Schedule 1 to the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) (“the Regulations”).[4]
[3] Exhibit R7, T Documents, vol. 1, T2, the reviewable decision, dated 27 February 2015, pp. 3 – 19.
[4] ss 3(1) and 41CA, the Act.
The ultimate issue for the Tribunal is whether or not the Secretary should have cancelled the entry of the Device in the Register under s 41GN(1)(b) of the Act. This requires the resolution of two subsidiary issues in this case. One is whether TFS refused or failed to comply with a condition to which the entry of the kind of device in the Register was subject. Resolution of that issue depended on whether, at all times while the inclusion of the Device in the Register had effect, TFS had available sufficient information to substantiate compliance with essential principles 2, 6 and 14 as required by s 41FN(3)(a)(i) of the Act. We note that the applicant has never relied on s 41FN(3)(a)(ii) in order to satisfy the requirements of s 41FN(3)(a). If the applicant did not meet the requirements of s 41FN(3)(a)(i), the second subsidiary issue is whether the Secretary should have exercised the discretion under s 41GN, to cancel the entry in the Device on to the Register.
For the reasons given in the preliminary decision given in this matter in TFS Manufacturing Pty Ltd v Minister for Health,[5] we are of the view that the material time for the purposes of determining the application is the period during which the Device was included in the Register, namely the period prior to cancellation on 5 November 2014. For the reasons set out below, we have decided to affirm the cancellation decision dated

1 October 2014, to cancel the entry of the Device in the Register under s 41GN(1)(b) which was itself affirmed by a delegate of the Minister for Health (the “Minister”) on

27 February 2015.
[5] [2017] AATA 2786 at [33] and [36].
BACKGROUND
In 2012, the Therapeutic Goods Administration (“the TGA”) commenced a review of medical devices included in the Register and that make therapeutic claims regarding incontinence, including urogynaecological mesh devices. As part of the ongoing review of these products, on 18 November 2013, a request was made by the Secretary to TFS under s 41JA(1) the Act, for information and documents about the Device.[6]
[6]Exhibit R7, T Documents, vol. 1, T26, Notice requiring information/documents to be provided, dated 18 November 2013, pp. 175 177.
On 10 April 2014, Dr Jane Cook, a delegate of the Secretary, sent a notice under s 41GN(2) of the Act to Mr Paul Zadow, Managing Director of TFS, notifying him of the proposed cancellation of the entry of the Device from the Register (“notice of proposed cancellation”). The basis of the proposed cancellation was that TFS had not complied with the conditions of inclusion for the Device in the Register. A Request for Clinical Evidence Assessment dated 18 March 2014, was annexed to the notice of proposed cancellation and provided particulars of deficiencies identified with the information and documents provided by TFS.[7] It also included recommendations. Relevantly, Dr Cook recommended:
“A literature review for such devices and their indication(s)/Intended Purpose(s), with a documented search strategy including databases searched, search terms used in any inclusion and exclusion criteria applied, in sufficient detail to enable the search to be reproduced if desired. This needs to demonstrate an adequate review of current available knowledge about a particular product or therapy. Then a critical discussion of the papers revealed by the search must be undertaken with particular emphasis on how the publications demonstrate safety and performance of the device under assessment of the indication(s) or Intended Purpose(s) claimed.”.[8]
[Emphasis in original]
[7]Exhibit R7, T Documents, vol. 1, T30-3, Attachment C: Request for Clinical Evidence Assessment, dated 18 November 2013, pp. 206 – 220.
[8]Exhibit R7, T Documents, vol. 1, T30-3, Attachment C: Request for Clinical Evidence Assessment, dated 18 November 2013, p. 217.
Mr Zadow contacted the respondent on 10 April 2014. A note of the telephone conversation was prepared on 14 April 2014 and records that Mr Zadow was advised that “He had also not included an evaluation by a clinical expert in the relevant field or identified adverse events in the journal articles that he provided”.[9] Mr Zadow said that he would provide the required information within 20 working days.
[9] Exhibit R7, T Documents, vol. 1, T31, Telephone note, dated 14 April 2014, p. 221.
On 17 April 2014, TFS was granted an extension to 6 June 2014 and an opportunity to provide its final response to the notice of proposed cancellation on that day.[10] This extension was accompanied by a requirement for TFS to provide an interim report by 19 May 2014 to the TGA.
[10]Exhibit R7, T Documents, vol. 1, T32, Email communication between TFS and TGA, dated 17 April 2014, pp. 222 – 223.
On 6 June 2014, TFS provided additional information to the TGA in response to the notice of proposed cancellation.[11] That information consisted of a letter in response to the compliance issues raised in the notice of proposed cancellation together with the following documents as appendixes:
(a)A Scientific Literature Review: TFS Tissue Fixation System dated 3 June 2014 (“SLR”);
(b)A Risk Management File TFS Tissue Fixation System dated 3 June 2014 (“RMF”);
(c)A Clinical Evidence Report: TFS Tissue Fixation System dated 3 June 2014 (“CER”); and
(d)Curriculum vitae for Maxwell Elliott Haverfield.
[11]Exhibit R7, T Documents, vol. 1, T36 – T 36-4, Response to notice of proposed cancellation, dated 6 June 2014, pp. 231 – 350.
On 10 June 2014, the TGA sent Mr Zadow an email requesting full copies of all references cited in the Clinical Evidence Report for assessment.[12] A file attaching copies of the cited references was provided to the TGA on the same date.[13]
[12]Exhibit R7, T Documents, vol. 1, T37, Email correspondence requesting references, dated 10 June 2014, p. 351.
[13]Exhibit R7, T Documents, vol. 1, T37, Email correspondence, dated 10 June 2014, pp. 353 - 354.
On 1 October 2014, after considering the submissions provided by TFS, the Secretary decided to cancel the entry of the Device in the Register. On 31 December 2014, TFS sought review by the Minister for Health, under s 60 of the Act, of the Secretary’s decision.[14]
[14]Exhibit R7, T Documents, vol. 2, T49, Request for reconsideration, dated 31 December 2014, pp. 648 – 672.
RELEVANT LEGISLATIVE PROVISIONS
Pursuant to s 41GN(1)(b) of the Act, the entry of a medical device in the Register may be cancelled if the person in relation to whom the kind of medical device is included in the Register, refuses or fails to comply with a condition to which that inclusion is subject. Prior to cancellation, a notice of proposed cancellation must be issued under s 41GN(2) of the Act to the person in relation to whom the device has been included in the Register.
Medical devices included in the Register must comply with the conditions set out in s 41FN of the Act. The condition at issue in these proceedings is found in s 41FN(3)(a)(i) of the Act which provides:
“(3) The inclusion of a kind of medical device in the Register is subject to conditions that:
(a) at all times while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register:
(i) has available sufficient information to substantiate compliance with the essential principles; …”.
The essential principles referred to in s 41FN(3)(a)(i) are set out in Schedule 1 to the Regulations.[15] Section 41FN(3)(a)(i) refers to the requirement that the person in relation to whom the kind of device is included in the Register “has available” sufficient information to substantiate compliance. We will return later in these reasons to what amounts to “sufficient information” and focus for the moment on what it means to have sufficient information “available”.
[15] s 41CA, the Act; r 2.1, the Regulations.
The ordinary meaning of the word “available” includes “able or ready to be obtained or used. …”.[16] Taken on its own, it might be thought that s 41FN(3)(a)(i) could be satisfied if the person were able to obtain sufficient information to substantiate compliance. The word “available” is not used in that way, however. It is preceded by the word “has”. That is a word whose ordinary meanings include “to possess or own”.[17] Therefore, in its context in s 41FN(3)(a)(i) the expression “has available” means that the person must have sufficient information to substantiate compliance with the essential principles in his or her possession or control to the extent that it can be put forward at any time, while the kind of device is in the Register. It is not enough that the literature, scientific literature or clinical data may exist or may be available should a person choose to search for it.
[16] Chambers 21^st Century Dictionary (“Chambers”).
[17] Chambers.
The requirement that it be available to the person at all times while the device is included in the Register is consistent with the nature of the scheme of registration under the Act. The Secretary carries out a preliminary assessment of an application for registration under s 41FDB.The assessment is focused on whether the application meets the requirements of s 41FDB(2). Among them is a requirement that the applicant has certified the matters in s 41FD, that the application has been in the form and manner specified and delivered to the Secretary, that the prescribed application fee has been paid, that the application is accompanied by prescribed information and that any required conformity assessment certificate is produced. Two of the matters that the person must certify under s 41FD relate to compliance with the essential principles and their terms are consistent with the conditions in s 41FN(3), to which the inclusion of a kind of medical device in the Register is subject. The first matter is that devices of the kind comply with the essential principles.[18] The other is that the person:
“(i)has available sufficient information to substantiate that compliance with the essential principles; or
(ii)has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; …”.[19]
[18] s 41FD(d), the Act.
[19] s 41FD(e), the Act.
Once the application has passed the preliminary assessment and the application has not been selected for audit under s 41FH of the Act, the Secretary must include the kind of device in the Register.[20] The scheme of registration clearly contemplates that there is a degree of self-regulation but, in doing so, attempts to ensure that the person seeking to enter the kind of device in the Register bears responsibility for the accuracy of the information that must be certified by the applicant when making the application. This is apparent from the fact that one element of the criminal offence created by s 41FE of the Act is that the person knows that a statement made in, or in connection with, a certification under s 41FD is false or misleading.
[20] s 41FF, the Act.
What amounts to “sufficient information” to substantiate compliance with the essential principles as required by s 41FN(3)(a)(i)? In our view, the answer to that question depends on the terms of the essential principle with which compliance must be substantiated. In the case of essential principle 14, it is determined by reference to

cll 8.3 and 8.5 of Schedule 3 to the Regulations[21], having regard to the terms of essential principles 2 and 6. We agree with the applicant that “sufficient” means

“enough; adequate …”[22] and does not mean “complete or perfect”. In order to amount to “sufficient information”, the information must be adequate to address the issues raised by the essential principles and must be drawn from literature that is sufficiently current to reflect contemporary material. What is sufficient is a matter that must withstand objective scrutiny and it is not enough that an applicant made its decisions on the basis of what it thought to be sufficient to substantiate compliance with the essential principles or that it did so at one time. Section 41FN(3)(a)(i) imposes an ongoing obligation on the person in relation to whom the kind of medical device is included in the Register. That is inherent in the nature of the obligation and what is, at least at the outset, in the nature of a

self-regulatory scheme.
[21] Part 8 of Schedule 3 to the Regulations contain cls 8.1 – 8.6.
[22] Chambers.
Essential Principle 14
Essential principle 14 provides that “[e]very medical device requires clinical evidence, appropriate for the use and classification of the device, demonstrating that the device complies with the applicable provisions of the essential principles”. The note to essential principle 14 refers to r 3.11 and the “clinical evaluation procedures”.
Subject to the exceptions in r 3.11(2), that do not apply in this case, r 3.11 provides that:
“… in addition to the conformity assessment procedures that are applied to a medical device in accordance with another regulation in this Division, the clinical evidence procedures must also be applied to the device, for the purpose of demonstrating that the device complies with the applicable provisions of the essential principles, in particular:
(a)clause 1 of Schedule 1 (identification of benefits and risks associated with the use of the device); and
(b)clause 3 of Schedule 1 (use of the device for its intended purpose); and
(c)clause 6 of Schedule 1 (acceptability of any side effects associated with the use of the device).”
In these proceedings, essential principles 2 and 6 have been identified as the applicable provisions of the essential principles. Essential principle 6 is summarised in

r 3.11(1)(c). Essential principle 2 is entitled “Design and construction of medical devices to conform with safety principles”. The identification of essential principle 6 and not essential principle 2 in r 3.11 does not detract from the applicability of the clinical evaluation procedures to essential principle 2 as well as to essential principle 6. We will return to them shortly. Schedule 3 of the Regulations sets out the “conformity assessment procedures”.[23] The manufacturer of a device must apply to the device those of the conformity assessment procedures applying to it.[24] Manufacturers are required to comply with the relevant conformity assessment procedures by virtue of s 41DA of the Act. The effect of r 3.11 is that a manufacturer must comply not only with the relevant conformity assessment procedures applying to its device, but must also comply with the requirements of the “clinical evaluation procedures”. These procedures are set out in Part 8 of Schedule 3 to the Regulations. As cl 8.1 provides:
“The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device to obtain and evaluate clinical data in relation to the kind of device.”
[23] r 4, the Regulations.
[24] r 3.4(3)-(4), the Regulations.
Clause 8.3 sets out the manufacturer’s obligation:
“(1)The manufacturer of a kind of a medical device must obtain clinical data in relation to the device in the form of either or both of the following:
(a)clinical investigation data in accordance with clause 8.4;
(b)a literature review in accordance with clause 8.5.
(2)The manufacturer must ensure that the clinical data obtained takes account of any medical device standard or conformity assessment standard that may apply to the device.”
[Emphasis added]

The applicant has not attempted to satisfy cl 8.3 by relying on cl 8.3(1)(a), which allows clinical data to be obtained in the form of clinical investigation data, in accordance with cl 8.4. Rather, the applicant has attempted to satisfy cl 8.3 by relying on cl 8.3(1)(b), which allows clinical data to be obtained in the form of a literature review, in accordance with

cl 8.5. Therefore, we have concluded that these proceedings concern cl 8.5. Relevantly, it provides:
“For clause 8.3, a literature review, in relation to a kind of medical device, includes:
(a)a compilation, prepared using a documented methodology, of published literature and unpublished scientific literature, both favourable and unfavourable, relating to medical devices of that kind, including the following:
(i)expert opinion;
(ii)information about the hazards and associated risks arising from the use of the device for its intended purpose, and the foreseeable misuse of the device;
(iii) information about the performance of devices of that kind, including a description of the techniques used to examine whether devices of that kind achieve their intended purpose; and
(b)a written report by an expert in the relevant field, being a report that contains a critical evaluation of the compilation of literature mentioned in paragraph (a).” [Emphasis in original]
Essential principles 2 and 6
We will now return to essential principles 2 and 6, for it is apparent from r 3.11 that the clinical evaluation procedures are applied for the purpose of demonstrating that the device complies with the applicable provisions of the essential principles. A literature review in accordance with cl 8.5 is one form in which TFS was permitted to obtain and evaluate clinical data in relation to the Device under cl 8.3(1)(b) and in compliance with cl 8.1. The requirements of essential principle 2 are:
“(1) The solutions adopted by the manufacturer for the design and construction of a medical device must conform with safety principles, having regard to the generally acknowledged state of the art.
(2)Without limiting subclause (1), in selecting appropriate solutions for the design and construction of a medical device so as to minimise any risks associated with the use of the device, the manufacturer must:
(a)first, identify hazards and associated risks arising from the use of the device for its intended purpose, and foreseeable misuse of the device; and
(b) second, eliminate, or reduce, these risks as far as possible by adopting a policy of inherently safe design and construction; and
(c) third, if appropriate, ensure that adequate protection measures are taken, including alarms if necessary, in relation to any risks that cannot be eliminated; and
(d) fourth, inform users of any residual risks that may arise due to any shortcomings of the protection measures adopted.
(3)In paragraph (2)(d):
‘residual risk’, for a medical device, means the risk remaining after the measures described in paragraphs (2)(a), (b) and (c) have been applied.”
[Emphasis in original]
Essential principle 6 states that:
“The benefits to be gained from the use of a medical device for the performance intended by the manufacturer must outweigh any undesirable effects arising from it use.”
As Mr Harris QC submitted on behalf of the applicant, terms used in the essential principles are not defined in either the Act or the Regulations. The terms “risks” and “hazards” are examples. The word “risks” is used in essential principle 2, where it is qualified by the word “associated”, this is also the case with cl 8.5(a)(ii) of the clinical evaluation procedures and in essential principle 1. The word “hazard” in its various forms is used in essential principle 2.
The ordinary meanings of those terms include the following, which would seem appropriate to the context:
“risk”: “… the chance or possibility of suffering loss, injury, damage, etc; danger. …”.[25]
“hazard”: “… a risk of harm or danger. …”.[26]
[25] Chambers.
[26] Chambers.
With regard to Mr Harris’s submission that the word “risks” is used in essential principle

2 to describe both a potential hazard, which arises from the use of the medical device, and the likelihood of that hazard occurring, it seems to us that this is so. Essential principle 2 requires the manufacturer to identify the harms, and so hazards, that may arise from the use of the device, whether for its intended use or by reason of any foreseeable misuse. It then requires the manufacturer to quantify the risk associated with each of those harms.
The ordinary meanings of the word “effect” include that of “…a result. …”.[27] An “undesirable effect”, therefore is a result that is “… not desirable; unpleasant or objectionable…”.[28] Mr Harris drew our attention to Item 4 of essential principle 13.4, which requires the instructions for use of a medical device to include: “Information about the intended performance of the device and any undesirable side effects caused by use of the device”. It is true that the expression “side effects”, rather than “effects”, is used, but the use of the expression “side effects” is appropriate in a document described as Instructions for Use (“Instructions for Use”)[29] as in Item 4. Its use in that context is also consistent with the use of the expression “undesirable effects” in essential principle 2. The meaning of the expression “side effects” is slightly broader than “undesirable effects” in that it may encompass all effects that are additional to those related to the purpose for which the medical device is intended, even though those effects may usually be undesirable. The ordinary meaning of a “side effect” is:
“1 an additional and usually undesirable effect, especially of a drug, eg nausea, drowsiness. 2 any undesirable additional effect.”[30]
[27]          Chambers.
[28]          Chambers.
[29]          Exhibit R7, T Documents, vol. 1, T12-6, Instructions for Use document for the Device, p. 78.
[30]          Chambers.
Whether qualified by the word “side” or “undesirable”, the meaning of the word “effect” or “effects” does not change. Essential principle 6 requires an assessment to be made of the effects, and so results or outcomes, arising from the use of the medical device. Those effects must then be themselves assessed to determine whether they can be described as “undesirable”. Those undesirable effects are weighed against the benefits to be gained from the use of the medical device. Essential principle 6 does not provide for a precise quantification of the benefits and undesirable effects and how they each weigh on the scales. That must be a matter of evidence and, ultimately, judgment in each case.
Australian Regulatory Guidelines for Medical Devices
The Australian Regulatory Guidelines for Medical Devices (“the Guidelines”) detail, in

s 3 of Part 1, the TGA’s approach to the requirements of the essential principles and provide guidance as to how a manufacturer of a medical device can demonstrate compliance with the essential principles. The Guidelines do not purport to be more than guidelines as to the way in which the Secretary and, on review, the Minister, view the interpretation of the Act and the considerations that should be taken into account in the exercise of any discretion conferred. As a statement of policy, the Guidelines cannot supplant the provisions of the Act. The Tribunal is not bound by the Guidelines, as the law lies in the statutory text. It follows that regard can only be had to the Guidelines if, and to the extent that, they are consistent with the Act.[31] To that extent, they can have an important role to play by serving:
“… to focus attention on the purpose which the exercise of the discretion is calculated to achieve, and thereby to assist the Minister and others to see more clearly, in each case, the desirability of exercising the power in one way or another. Decision-making is facilitated by the guidance given by an adopted policy, and the integrity of decision-making in particular cases is the better assured if decisions can be tested against such a policy. By diminishing the importance of individual predilection, an adopted policycan diminish the inconsistencies which might otherwise appear in a series of decisions, and enhance the sense of satisfaction with the fairness and continuity of the administrative process.”[32]
CONSIDERATION
[31]Drake v Minister for Immigration and Ethnic Affairs (1979) 2 ALD 60 at 69-70 per Bowen CJ and Deane J.
[32]Re Drakeand Minister for Immigration and Ethnic Affairs (No. 2) (1979) 2 ALD 634 at 640 per Brennan J.
Essential principle 14
Clause 8.5 has three features. First, it requires a “compilation, prepared using a documented methodology, of published literature and unpublished scientific literature, both favourable and unfavourable” relating to medical devices of the kind that accord with the Device. Second, the compilation must include the matters specified in cll 8.5(a)(i), (ii) and (iii). Those first two features are the subject of cl 8.5(a). The third feature of cl 8.5 is set out in cl 8.5(b). It requires a critical evaluation of the compilation in the form of a report by an expert in the relevant field.
In its ordinary meaning, a “compilation” is a collection or organisation of, in this case, published literature and unpublished scientific literature that meets the criteria set out in cl 8.5(a) and is directed to demonstrating that the device complies, or does not comply, with the applicable provisions of essential principles 2 and 6. It must be prepared using a documented methodology. A “methodology” is a “… system of methods and principles used in a particular activity…”.[33] To be “documented”, the methodology must be “…in written form…”.[34] It follows that, in order for a compilation to be prepared using a documented methodology, it must be possible to apply that documented methodology to achieve an outcome that will be consistent. Given the nature of the regulation imposed by the Act, that is an important feature, because the methodology must be documented with such precision that the TGA is able not only to apply it and to achieve a similar outcome, but to assess the methodology itself to ensure that it will return literature as required by cl 8.5(a). That the documented methodology does so is crucial to the worth of the written report by an expert in the relevant field. That expert is required to include a critical evaluation of the compilation of literature. His or her critical evaluation of the literature, and so the value of that critical evaluation, will necessarily be dependent on the comprehensiveness, or otherwise, of the compilation itself.
[33] Chambers.
[34] Chambers.
Given the changing content of electronic databases, it cannot be expected that the outcome achieved will necessarily reflect precisely the outcome achieved when the compilation was produced. Content may have been added to, or removed from the databases being searched, but any variation in the results achieved by applying the documented methodology should be a reflection only of a change in the content of the database. With that one qualification, what can be expected is that the documented methodology will return literature of the sort identified in cl 8.5(a) consistently, regardless of the person conducting the search. This means careful identification of the search terms, the combination of search terms and the terms used to narrow or limit the scope of the search so that they capture all relevant literature.
In the case of the Device, those terms must be such that they address essential principles 2 and 6, which are the subject of separate consideration regarding compliance issues in this case, but also address essential principles 1 and 3 as they are specifically identified in r 3.11. The substance of essential principles 1 and 3 also find expression in cll 8.5(a)(ii) and (iii), which require the compilation to include literature about the hazards and associated risks arising from the use of the device for its intended purpose and foreseeable misuse, as well as information about the performance of devices of that kind, including a description of the techniques used to examine whether the devices of that kind achieve their intended purpose.
Identification of the purpose of the device under consideration is also essential in identifying the focus of the preparation of the compilation of the literature review itself. The focus is the “…medical devices of that kind…” and identification of their purpose is an essential element in identifying their “kind”. Identification of their purpose is also an essential element in identifying hazards and associated risks arising from the use of the device for its intended purpose.
Before leaving the requirements of the literature review set out in cl 8.5, we would also note that the clause deals quite separately with the compilation of literature on the one hand and on the other, the written report by an expert critically evaluating that compilation. Provided the compilation has been prepared in accordance with cl 8.5(a), there is no requirement that it has to have been prepared by an expert. What is expected of an expert in the relevant field, is a written report containing an evaluation of the compilation of literature. As Mr Hanks QC with Ms Foley of counsel submitted on behalf of the Minister, a written report containing the relevant evaluation must be a written report “…by an expert in the relevant field…”. It is not enough that a written report has been prepared by a person, who may or may not be an expert, but has been signed off, or approved, by another person who is an expert in the relevant field.
Clause 8.5(b) requires that the report contain a “critical evaluation” of the compilation of literature mentioned in cl 8.5(a). The word “critical” has several meanings, but that which is most relevant in this context is “…involving analysis and assessment…”.[35] To “evaluate” is “… to form an idea or judgement about the worth of something...”.[36]. Therefore, to have a critical evaluation of the compilation of literature, an analytical assessment of the compilation of literature must be undertaken that is directed to the value or worth of the literature demonstrating that the Device complies with the applicable provisions of the essential principles as required by essential principle 14 and s 14FN(3)(a)(i) of the Act. Whether a critical evaluation of literature does that will depend on its content, but also having regard to any acknowledged or identifiable biases of the expert who has written the report.
[35] Chambers.
[36] Chambers.
The applicant predominantly relies on two key documents to satisfy cl 8.3(1)(b) and, in turn, cl 8.5, and so the requirements of essential principle 14. They are the SLR[37] and the CER[38]. Correspondence between Brandwood Biomedical (on behalf of TFS) and the TGA, states that the SLR was used to update the RMF document.[39] The applicant relies on the RMF to supplement the CER and SLR and to demonstrate that the Device complies with essential principles 2 and 6.
[37]          Exhibit R7, T Documents, vol. 1, T36-1, Appendix A: SLR, dated 3 June 2014, pp. 235 – 248.
[38]          Exhibit R7, T Documents, vol. 1, T36-3, Appendix C: CER, dated 5 June 2014, pp. 300 - 343.
[39]          Exhibit R7, T Documents, vol. 1, T36-2, Appendix B: RMF, dated 3 June 2014, pp. 249 - 299.
Each of the documents sets out its purpose in the following terms:
SLR
“The purpose of the review is to identify and categorise potential risks related to the TFS device where possible – according to the intended use, application or manufacture.
Risks include hazards, incidents and adverse events cited within the literature. The identification of potential hazards, risks and experiences with similar devices or technologies is intended to facilitate and support the overall risk management process of the TFS device by TFS Manufacturing, as well as to identify and mitigate overall product risk.”[40]
[40]          Exhibit R7, T Documents, vol. 1, T36-1, Appendix A: SLR, dated 3 June 2014, p. 237.
CER
“This is the clinical evidence report for Tissue Fixation System manufactured by TFS Manufacturing.
This report has been prepared in accordance with Essential Principal [sic] 14 of the Australian Therapeutic Goods (Medical Devices) Regulation, MEDDEV 2.7.1 – Guidelines for Medical Devices – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies – December 2009, Essential Requirement 6.2 of the European Medical Device Directive and GHTF/SG5/N2R8:2007 – Clinical Evaluation.
This report considers the following clinical and non-clinical data.
·        The product risk assessment conducted by the manufacturer.
·The clinical history of the TFS device as represented in the post market customer feedback.
·        The published clinical literature relevant to the TFS device.
·Post market data contained in the publicly available Manufacturer and User Device Experience (MAUDE) database maintained by the United States Food and Drug Administration (US FDA).
The objective of this report is to demonstrate support for the performance and safety of the Tissue Fixation System manufactured by TFS Manufacturing for its intended purpose.”[41]
[41]          Exhibit R7, T Documents, vol. 1, T36-3, Appendix C: CER, dated 5 June 2014, p. 304.
RMF
“This report documents the Risk Assessment for the Tissue Fixation System (TFS). It is intended to document:
·        the hazards associated with the use of the device;
·        the assessment of the risks associated with each hazard; and
·        the mitigation strategies applied where required.
This report provides a reference for the investigation and implementation of the mitigation strategies as part of the product design, development and post market processes. The report also provides the primary evidence for compliance of the Tissue Fixation System with:
·Essential Principle 2 of Schedule 1 of the Australian Therapeutic Goods Regulations (Medical Devices), 2002 and
·Essential Requirement 2 of Annex IX of the European Medical device Directives (EC 93/42)
·EN ISO 14971-2012 Medical Devices – Application of Risk Management to Medical Devices.”[42]
[42]          Exhibit R7, T Documents, vol. 1, T36-2, Appendix B: RMF, dated 3 June 2014, p. 251.
[Emphasis in original]
42.The SLR, CER and the RMF each set out their methodology and include the following statements:
SLR
“A systematic search was conducted in the PubMed online database…. PubMed is provided by the U.S. National Library of Medicine incorporating over 17 million citations from Medline, a comprehensive literature database containing citations and abstracts from more than 5,000 biomedical journals published in over 80 countries.
On-line resources of regulatory, research and special interest organisations such as the US Food and Drug Administration (FDA) were also examined for further material.
An initial exploratory search of PubMed using the vocabulary tissue fixation system returned limited scientific literature. The search was then expanded using synonymous search terms and similar devices name associated with tissue fixation device.
The inclusion criteria for the searches are provided below:
Device
·TFS OR Tissue Fixation System (Primary) OR Mesh Tapes (Primary) OR Vaginal Sling (Primary) Sub-urethral slings (Secondary) OR Mid-urethal sling (Secondary)
Hazard:
·Severe Hematoma OR Pain OR Distortion OR Muscle Spasm OR Constriction OR Infection OR Sterilization OR Blood Loss OR Bruising OR Urinary retention OR Mesh extrusion OR Hip and Leg pain OR Fistula
To refine the search returns, key words were varied in the course of the research in order to improve the returned results. A large body of publications were returned from the expanded search (1,000+), where the results were further filtered to clinical trial or review articles published in the most recent ten (10) years.
·        All citations referenced are detailed in Appendix A.
·        Full text articles are located at Appendix B.
·Additional full text articles retrieved, but not cited has been included for supplementary reference purposes only at Appendix C.”[43]
[43]          Exhibit R7, T Documents, vol. 1, T36-1, Appendix A: SLR, dated 3 June 2014, pp. 237 – 238.
[Emphasis in original]
CER
“A systematic literature search was conducted in the PubMed online database ( incorporating the Medline journal literature search engines. PubMed is the largest and most comprehensive online database of medical literature. PubMed comprises more than 23 million citations for biomedical literature from MEDLINE, life science journals, and online books.
The literature on surgical meshes is extensive. The inclusion criteria for the searches include device and hazard related terms as shown below:
Device related:
TFS OR Tissue Fixation System (Primary) OR Mesh Tapes (Primary) OR Vaginal Sling (Primary) OR Sub-urethral slings (Secondary) OR Mid-urethral sling (Secondary)
Hazard related:
Severe Hematoma OR Pain OR Distortion OR Muscle Spasm OR Constriction OR Infection OR Sterilization OR Blood Loss OR Bruising OR Urinary retention OR Mesh extrusion OR Hip and Leg pain OR Fistula.
To refine the research returns, key words were varied during the course of the research in order to improve the returned results.
The search strategy made use of the Medline Medical Subject Heading (MeSH) terms. The primary search term was the ‘MeSH Major Topic Heading’ ‘suburethral slings’. MeSH terms are a controlled vocabulary used to index the Medline subset of PubMed. MeSH Major Topics are index terms which apply to the major topic(s) of a given article. They indicate that the particular term was the primary focus of the article.
A large body of publications were returned from the search (over 1000). The results were thus filtered to:
·Clinical trials – Articles specifically describing clinical trials related to surgical meshes and slings;
·Review articles – Articles which provide peer reviewed overview of the clinical knowledge in the field;
·Articles published in the last 10 years – Recent literature – primary research papers representing the state of the art.
The combined literature was screened by inspection of title and abstract to select the relevant articles for detailed review.
Considering the intended purpose of the device and the key risks to safety and performance identified in risk assessment, the literature was reviewed with particular focus on:
·Safety – in relation to the hazards identified in the Risk Assessment Report as well as the Scientific Literature Review;
·Performance – in relation to the ability of surgical meshes or slings to reinforce damaged ligaments or fascia in patients for the treatment of pelvic floor conditions.
Please refer to Appendix E Reference List and Copies of Articles Reviewed.”.[44]
[Emphasis in original]
[44]          Exhibit R7, T Documents, vol. 1, T36-3, Appendix C: CER, dated 5 June 2014, pp. 313 – 314.
RMF
“This Risk analysis relies principally on a consideration of the technical nature of the device and its quantitative and qualitative characteristics (Table 1) and a hazards analysis in which all of the potential hazards which may affect the device are identified and assessed for severity and likelihood (Table 2). The hazards are categorised according to these assessments and the need for risk mitigation is determined.
There should be no unacceptable risks present after risk mitigation actions have been taken. The supply of the device should only proceed if a risk benefit analysis shows that the residual risks are outweighed by the benefits of the use of the device in the context of the current state of the art of relevant clinical practice of any alternative therapeutic approaches which may be available.”[45]
[Emphasis in original]
[45]          Exhibit R7, T Documents, vol. 1, T36-2, Appendix B: RMF, dated 3 June 2014, p. 251.

On the basis of the methodologies provided in the CER and SLR, we conclude that the search results were refined by varying the key search words on an ad hoc basis, and the returned literature was filtered and then screened prior to detailed review. While initial inclusion criteria for the search are included in the CER and SLR, the specific methodology of refining the key search terms and screening the articles for relevance are not adequately explained or justified. As an example, we refer to the CER, the methodology we have summarised in the preceding paragraph. The CER states that over 1,000 publications were returned from the search and that they were then filtered to identify clinical trials related to surgical meshes and slings, review articles providing peer review overviews of the field and articles published in the previous ten years these being primary research papers representing the state of the art. Beyond the statement of the results that filtering was intended to achieve, nothing appears in the CER regarding the filters that were used to identify the three categories of literature. What, for example, identified a primary research paper as “representing the state of the art”? What criteria were applied to make that assessment? In the absence of detailed criteria, we are not satisfied that the literature review is reproducible.
A reference list and copies of articles reviewed is annexed to the CER.[46] Likewise, articles referenced in the SLR are attached to the SLR.[47] The CER and the SLR appear to rely on different bodies of literature. This is despite the use of the same database selection, inclusion criteria and filtering steps in the two reports.
[46] Exhibit R7, T Documents, vol. 1, T36-3, Appendix C: CER, dated 5 June 2014, pp. 341 – 343.
[47] Exhibit R7, T Documents, vol. 1, T36-1, Appendix A: SLR, dated 3 June 2014, pp. 245 – 248.
Dr Alexander Stevenson, a medical practitioner, expressed in his expert report dated

25 April 2018, that a systematic literature search should be designed to identify all of the literature relevant to a particular clinical question so as to minimise bias. He stated that the methods described in the Cochrane handbook for systematic reviews were the “…gold standard…” in this area.[48]
[48] Exhibit R8, Report of Dr Stevenson, dated 25 April 2018, para [15], p. 4.
Dr Stevenson said in his report that a good quality literature search would interrogate several databases and that he would usually expect a search of MEDLINE, EMBASE and CENTRAL. As such, the use of only one database, in this case MEDLINE, was a “significant limiting factor” in the literature search.[49] He identified additional limitations, namely, the fact that the results returned by the search were themselves filtered by reference to three criteria, and that there had been no analysis of the results of the literature search. Dr Stevenson says it appears that the authors of the CER conducted

three searches in order to reduce the number of articles examined, that this had potentially limited the data retrieved and that it was likely that important research was missed. At hearing, Dr Stevenson accepted that the MEDLINE database was the largest database, but he ultimately confirmed his opinion that the search undertaken was limited.[50]
[49] Exhibit R8, Report of Dr Stevenson, dated 25 April 2018, para [27], p. 7.
[50] Transcript of proceedings, 18 May 2018, p. 243, pp. 248 – 249.
Ms Heather Eaton, a research assistant/academic librarian, was engaged by TFS in 2015. Ms Eaton was engaged to assist with the literature search review, critical evidence assessment and prepare documents that were submitted to the TGA in 2016. She was not involved in preparing the CER or SLR. In her evidence, Ms Eaton says that she prepared a systematic review of the Device by following instructions provided by the TGA and by reviewing the TGA Guidelines and essential principles contained in Schedule 1 of the Regulations. The results of the systematic review undertaken by Ms Eaton are contained in a document titled Tissue Fixation System- Systematic Review 31/3/2018 (“2018 Literature Review”) and annexed to her report dated 31 March 2018.[51]
[51] Exhibit A1, Report of Ms Eaton, dated 3 April 2018, pp. 17 – 455.
In his report dated 25 April 2018, Dr Stevenson evaluates the literature search and analysis undertaken by Ms Eaton in her 2018 Literature Review. He states that “The search, data extraction and quality assessment appears to have been conducted by one individual. These are potentially significant limitations however the report is generally of good quality”.[52] He states that the search strategy in the 2018 Literature Review was well described and that it “…includes a comprehensive range of databases as well as utilizing hand searching, reference list searching and contacting of experts in the field”.[53] Dr Stevenson says that the inclusion and exclusion criteria in the 2018 Literature Review were specific enough to be reproducible and that this was in contrast to the CER and SLR; where the scope of the search was limited. He further stated that the process of evidence assessment and data collection in the 2018 Literature Review was appropriate, clear and transparent, which again was in contrast to the CER and SLR; which he said did not have a clearly described plan for data collection or assessment.
[52] Exhibit R8, Report of Dr Stevenson, dated 25 April 2018, para [67], p. 16.
[53] Exhibit R8, Report of Dr Stevenson, dated 25 April 2018, para [68], p. 16.
We accept the evidence given by Dr Stevenson, as described in the previous paragraphs.
Relevant scientific literature was missed in the searches conducted for both the SLR and CER. This is apparent from the material exhibited to the report of Ms Eaton dated 3 April 2018, and the affidavit of Mr Zadow dated 23 April 2018, which disclosed that a number of relevant studies were missed in the search conducted for both the SLR and the CER.[54] The paper by P Petros and H Inoue entitled “Transvaginal perineal body repair for low rectocele” published online on 16 February 2013[55] (“Petros and Inoue paper”) is one example of an omitted article, with clear relevance to the issues to be addressed under the literature review. Mr Zadow annexed the article to his affidavit sworn on 23 April 2018, but it is clear from his earlier affidavit dated 4 April 2018, that it had been omitted from the compilation. The paper discussed the authors’ technique of low rectocele repair, which is based on the approximation and lifting of the laterally displaced perineal bodies using the Tissue Fixation System.
[54] Exhibit A5, Affidavit of Mr Zadow, dated 23 April 2018.
[55] Tech Coloproctol (2013) 17(4): 449 – 454.
The Petros and Inoue paper specifically concerned the Device and discussed patient outcomes for two cohorts. The results reveal no intraoperative complications, but identify two post-operative complications which occurred in the initial group of operations, attributable to faulty technique. The paper observed that a correction in surgical methodology resulted in no further complications and is plainly relevant. However it was not included or critically evaluated in the CER or SLR. This further demonstrates the inadequacies in the literature review undertaken.
Identification of the intended purpose for the Device is an essential part of the literature review. This is evident from clause 8.5(a)(ii) and (iii). The intended purpose of the Device is described in numerous documents as follows:
(a)The intended purpose for the Device is described in the Register as follows:
“The placement of synthetic mesh tape to cure female urinary or faecal incontinence and vaginal prolapse.”[56]
[56]Exhibit A3, Affidavit of Paul Andrew Zadow, Attachment: PAZ 1, Conformity Assessment Certificate and ARTG Certificate, p. 17.
(b)The objective of the CER, as described in the document, is to demonstrate support for the performance and safety of the Device for its intended purpose. The Device description and intended use contained in the CER does not mention clinical endpoints and/or the purpose of the Device. Instead it states, inter alia:
“The TFS device can be used (by those trained in its use), to reinforce the pubourethral ligaments anteriorly, the uterosacral ligaments and corpus perinei posteriorly, the Arcus Tendineus Fascia Pelvis and cardinal ligament laterally.”[57]
(c)In the SLR, the intended purpose is described as follows:
“It is intended for the treatment of female pelvic floor conditions, including urinary incontinence, vaginal prolapse, nocturia, chronic pelvic pain and some faecal incontinence.”[58]
(d)The Instructions for Use document for the Device states under indications for use:
“The TFS system is a universal connective tissue repair method designed to reinforce damaged ligaments or fascia, and is especially applicable to the pelvic floor. It can be used (by those trained in its use), to reinforce the pubourethral ligaments anteriorly, the uterosacral ligaments and corpus perinei posteriorly, the Arcus Tendineus Fascia Pelvis and cardinal ligament laterally… It can be used alone or in combination with mesh sheets to reinforce pubocervical and rectovaginal fascia.”[59]
[57]          Exhibit R7, T Documents, vol. 1, T36-3, Appendix C: CER, dated 5 June 2014, p. 304.
[58]          Exhibit R7, T Documents, vol. 1, T36-1, Appendix A: SLR, dated 3 June 2014, p. 237.
[59]          Exhibit R7, T Documents, vol. 1, T12-6, Instructions for Use document for the Device, p. 78.
Dr Darren Gold, a colorectal surgeon, accepts that the intended purpose of the Device is described inconsistently across the documents. At hearing, Dr Gold accepted that the SLR described the intended purpose of the Device for several conditions, including faecal incontinence and accepted that the CER did not specifically address clinical evidence relevant to faecal incontinence.[60] When questioned about why, in those circumstances, he did not accept the report of Associate Professor David Lubowski[61], which states that the CER does not support the use of the Device for colorectal conditions,

Dr Gold replied, inter alia:
“If you’re focusing on the CER then maybe it doesn’t involve faecal incontinence but as I said in my paper the symptomology with which women present to me is not faecal incontinence. It’s not nocturia. This is the mistake that has been made. Patients go to the colorectal surgeon and they say I have faecal incontinence, and they manage it and then at the end of it, whether they’re better or not, predominantly not, they say now who shall I go and see about my bladder. And the whole point is it is a multiplicity of symptoms in various parts of the pelvis, in various organs, that have a common cause, all of which are addressed simultaneously by the tissue fixation device based on the integral theory, which will produce a significant improvement in all of those symptoms simultaneously…”.[62]
[60] Transcript of proceedings, 18 May 2018, p. 243, pp. 189 – 191.
[61]Associate Professor Lubowski is a Conjoint professor at the Univesity of NSW, Head of the Department of Colorectal Surgery at St George Hospital and a Colorectal Section Editory for the ANZ Journal of Surgery.
[62] Transcript of proceedings, 18 May 2018, p. 189
In his report dated 18 April 2018, Dr Gold explains that:
“The integral theory was developed by Petros and Ulmsten and first published in 1990, which was the first new, published understanding of pelvic floor function for over a century. In 1993, Petros and Ulmsten wrote their second edition of the Integral Theory, It placed the cause of the symptoms and anatomical prolapse on weakened suspensory ligaments. The first ligament to undergo surgical repair, was the pubourethral ligament, responsible for stress urinary incontinence. It is one of the most researched surgical methods in the history of surgery. The mid‑urethral sling, a commonly used technique to treat stress urinary incontinence, was developed by Petros and Ulmsten based on the Integral Theory”.[63]
[References omitted]
Dr Gold says that the Device was an extension of the mid-urethral sling and was developed to repair all of the ligaments in the pelvis, responsible for other symptoms of the pelvic floor disorders i.e. overactive bladder, nocturia, urgency and urge incontinence, pelvic pain, faecal incontinence and obstructive defecation. He claims that the integral theory explains how the other ligaments in the pelvis are responsible for these other symptoms. Dr Gold says that based on the integral theory, augmentation of the other pelvic ligaments is reasonably predicted to the same significant cure improvement rate of the other symptoms.[64] He relies on the integral theory and on his own experience in using the Device for colorectal conditions.
[63] Exhibit A11, Report of Dr Gold, dated 18 April 2018, p. 3.
[64] Exhibit A11, Report of Dr Gold, dated 18 April 2018, p. 11.
Contrary to the evidence of Dr Gold, Associate Professor Lubowski, states in a report dated 4 May 2018: whether the Device effectively repairs the listed ligaments as described in the CER, SLR and Instructions for Use, is a concept that is peripheral to the treatment of faecal incontinence. He says that:
“Failure of these ligaments has not been studied in women with faecal incontinence. There is currently no high level scientific literature which serves to demonstrate how damage to these ligaments will lead to faecal incontinence, nor is there evidence that shows the reinforcing these structures improves the symptoms of faecal incontinence”.[65]
Regarding the integral theory, Associate Professor Lubowski states:
“The integral theory proposed to explain various forms of pelvic organ prolapse does not address the non-anatomical and physiological causes of faecal incontinence, and has not been tested with faecal incontinence. In some of the papers in the Clinical Evidence Report and the Scientific Literature Review there are passing comments and claims about improvement in faecal incontinence without reference to any of the well-established principles of objective assessment of faecal incontinence. Similarly, there are references to improvement in obstructive defecation due to repairing a rectocele. Faecal incontinence and obstructed defecation are complex multifactorial conditions, which have occupied a large segment of the colorectal literature for over four decades. In my experience working in a Pelvic Floor Unit of a tertiary referred teaching hospital, where I and other colorectal surgeons have collaborated with, and work closely with urogynaecologists, urologists and clinical nurse specialists, these various colleagues have developed an understanding of the complexity of diagnosis and management of faecal incontinence and they have applied the principles explained in the colorectal literature in order to assess faecal incontinence in obstructive defecation along proven and widely accepted lines, unrelated to mechanisms proposed in the integral theory.
From a colorectal perspective, whether the TFS procedure reinforces the ligaments and perineal body is a question which is fundamentally peripheral to the efficacy of the procedure, and cannot satisfy central principle 6 and 14.”
[Emphasis added]
[65] Exhibit R11, Report from Associate Professor Lubowski, dated 4 May 2018, pp. 2 -3.
In summary, Associate Professor Lubowski’s opinion was that the clinical evidence in the CER did not support the use of the Device for colorectal conditions, and in fact neither the CER nor the SLR provided evidence that the Device was effective for colorectal conditions.
We prefer the evidence of Associate Professor Lubowski to that of Dr Gold. Our reasons include the following. At hearing, Dr Gold was asked under cross-examination about his qualifications and publications. While we accept that Dr Gold has expertise in the field of colorectal surgery, he sought to move beyond his qualifications and experience into matters falling within the different fields of gynaecology and urogynaecology. In cross‑examination he did not agree that colorectal surgery and proctology were specialties different from gynaecology and urogynaecology. He said that he considered himself an expert in gynaecology and urogynaecology as far as pelvic reconstructive surgery for pelvic dysfunctions was concerned. This position appears to be based on his adherence to the integral theory. He said in response to a question about his expertise being properly described as colorectal surgery:
“…it is an integrated system. The bladder, the vagina and the bowel work together. They work in concert, they work in conjunction with one another. The only way in which you’re ever going to provide a solution to the problems of female dysfunction which affects over 1 billion women globally is to look at them together. To look at them in an integrated manner and to tear down the dividing lines that have prevented progress for a century”.[66]
[66] Transcript of proceedings, 18 May 2018, p. 171.
Dr Gold was not measured in the way he dealt with questions. He did not appear to listen to questions and was not prepared to evaluate alternative possibilities, and respond to them in an objective way.
Dr Gold was not an impartial expert on the Device. During cross-examination Dr Gold accepted that he was an advocate for the Device and agreed that it was something about which he was very passionate. He said that it was “transformative”. When it was suggested to Dr Gold that the Device was “revolutionary” he responded “Without question”.[67]
[67] Transcript of proceedings, 18 May 2018, p. 179.
Dr Gold has published a book about the integral theory, describing how it underpins the Device. He said that the book is written about the life work of Professor Petros, and is an explanation of the integral theory, its discovery and the lack of progress to date.

Dr Gold has published statements in connection with the book, including that he has been prevented by “jealous doctors” and the Australian government from using his skills to “cure hundreds of women”.[68] At hearing, he confirmed that he still stood by those comments “One hundred percent”.[69]
[68] Transcript of proceedings, 18 May 2018, p. 181.
[69] Transcript of proceedings, 18 May 2018, p. 181.
Additionally, the evidence of Dr Elizabeth Gallagher, an obstetrician and gynaecologist, is consistent with the evidence of Associate Professor Lubowski as to the conclusion that the available material is insufficient to support the intended use of the Device as described in the CER and SLR. She says in her report dated 8 May 2018, that “There is no analysis of the individual studies, no reference to individual ligaments, nor any effort made to support the Intended Use in the clinical Evidence Report”.[70] In particular, she states that:
“…the scientific literature review does not contain any critical analysis of clinical evidence to support the statement ‘It is intended for the treatment of female pelvic floor conditions, including urinary incontinence, vaginal prolapse, nocturia, chronic pelvic pain and some faecal incontinence’”.[71]
We accept Dr Gallagher’s evidence.
[70] Exhibit R9, Report of Dr Gallagher dated 8 May 2018, pp. 4 – 5.
[71] Exhibit R9, Report of Dr Gallagher dated 8 May 2018, p. 5.
For these reasons, we are not satisfied that the intended purpose of the Device has been adequately identified for the purposes of the literature review.[72] In regards to colorectal conditions, we are not satisfied that the clinical evidence in the CER and SLR supports the use of the Device in this regard, nor does it provide evidence of the Device’s effectiveness for these conditions.
[72] sch 3, cl 8.5, the Regulations.

The CER and RMF refers to the role played by an expert in its preparation:
CER
On the signatory page of the SLR, the following statement appears:
“This clinical evidence report was compiled for TFS Manufacturing. It has been reviewed and endorsed by the following competent clinical expert (see Appendix A for the curriculum vitae):
Dr. Maxwell Haverfield, Senior Specialist, Department of Obstetrics & Gynaecology (Unit Head Pelvic Floor Reconstruction and Continence Clinic)
The Northern Hospital 185 Cooper St, Epping Victoria. 3076.”.[73]
[Emphasis in original]
Further, it is stated in the CER:
“This clinical evidence report has been reviewed and endorsed by an independent competent clinical evidence in accordance with MEDDEV 2.7.1 – Guidelines for Medical Devices – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies – December 2009, Essential Principal 14 of the Australian Therapeutic Goods (Medical Devices) Regulations, Essential Requirement 6.2 of the European Medical Devices Directive and GHTF/SG5/N2R8:2007 – Clinical Evaluation.”.[74]
[73]          Exhibit R7, T Documents, vol. 1, T36-3, Appendix C: CER, dated 5 June 2014, p. 301.
[74]          Exhibit R7, T Documents, vol. 1, T36-3, Appendix C: CER, dated 5 June 2014, p. 302.
RMF
At [8] of the RMF, there is a list of people described as individuals who had participated in the preparation of the risk assessment. They include Mr Zadow, the Managing Director of TFS, who has expertise in regulatory affairs, product design and development and is a product specialist, and Mr Steve Axon, who is TFS’s Production Manager and has expertise as a Mechanical Engineer – Class 3.[75]
[75]          Exhibit R7, T Documents, vol. 1, T36-2, Appendix B: RMF, dated 3 June 2014, p. 258.
As we have noted, cl 8.5(b) requires a “…written report by an expert in the relevant field…” containing a “…critical evaluation of the compilation of literature…” as mentioned in cl 8.5(a). Consistently with that requirement, the Guidelines provide that clinical reports should contain a critical review of the data presented, and that critical review should be undertaken by a “clinical expert”.[76] The expert must be involved in the preparation of the report to the extent that the expert must take ownership of, or responsibility for, the content of the report.
[76] Exhibit R1, The Guidelines, p. 68.
There is no evidence to suggest, nor is it contended by TFS, that the SLR contains an opinion by a clinical expert. TFS suggests that the CER contains the relevant critical evaluation to satisfy this requirement.
For the following reasons, we are of the view that neither the CER nor the SLR meet the requirement of cl 8.5(b).
We are not satisfied that the CER is written by an expert in the relevant field and that it includes the necessary critical evaluation of the compilation of literature.
Mr Zadow’s evidence is that he engaged Brandwood Biomedical to prepare the clinical evidence for the TGA. At hearing, Mr Zadow stated that he wrote the CER with someone from Brandwood Biomedical[77]
[77] Transcript of proceedings, 16 May 2018, p. 57.
Under the heading “Signatory”, the CER states that the report was compiled for TFS and had been “reviewed and endorsed” by a “competent clinical expert”, namely,

Dr Maxwell Haverfield, senior specialist, Department of Obstetrics & Gynaecology (Unit Head Pelvic Floor Reconstruction and Continence Clinic).[78] Dr Haverfield’s evidence is consistent with this record. In his report dated 19 March 2018, he does not describe himself as the author but instead states that he was “…involved in the preparation and review…” of the report.[79] At hearing, Dr Haverfield described his involvement as consisting of telephone discussions “at least once a week” for several weeks in consultation with Mr Zadow and persons from Brandwood.[80] He said he reviewed a draft of the CER, but said that he would not have made very many changes as it was a well prepared draft.
[78] Exhibit R7, T Documents, vol. 1, T36-3, Appendix C: CER, dated 5 June 2014, p. 301.
[79] Exhibit A8, Report of Dr Haverfield, dated 19 March 2018, para [34].
[80] Transcript of proceedings, 17 May 2018, p. 102.
For the following reasons, we are not satisfied the CER contains a critical evaluation of the compilation of literature as required by cl 8.5(b).
TFS contends that the CER contains a critical evaluation of the compilation of the literature, namely, what is contained under the heading “Overview” at [4.3.2], which provides:
“Surgical slings have a lengthy history in clinical medicine, dating back almost a century [1]. Their use is universally established as the least invasive surgical procedure for the treatment of pelvic floor conditions [2]. Specifically, several authors advocate for the performance and safety of the TFS mini-sling, including for the long-term treatment of uterine/vault prolapse repair as well as for the effective treatment of urodynamic stress urinary Incontinence [2-10].”.[81]
The footnotes each referred to an article but there was no further analysis of those articles. We give as examples those set out in footnotes [1] and [2]:
“[1]      Klinge U, Binneboesel M, Kuschel S, Schuessler B. Demands and properties of alloplastic implants for the treatment of stress urinary incontinence. Expert review of medical devices 2007; 4:349-59.
“[2]      Angioli R, Montera R, Plotti F, Terranova C, Aloisi A, Zullo MA. Suburethral sling in autoimmune patients: complications, quality of life, and success rate. International urogynecology journal 2012; 23:453-7.”.[82]
[81]          Exhibit R7, T Documents, vol. 1, T36-3, Appendix C: CER, dated 5 June 2014, p. 314.
[82]          Exhibit R7, T Documents, vol. 1, T36-3, Appendix C: CER, dated 5 June 2014.
We are not satisfied that the above passage is a critical evaluation of the compilation of literature. It is no more than a rudimentary summary of ten referenced articles. The lack of detail in the passage requires the reader to source the referenced articles to understand the basis for the statements contained in the summary. The passage does not include any analysis or assessment of the literature, so that it can be said to be a critical evaluation, nor does it make reference to any literature, or whether there was any such literature, that reached a contrary or different conclusion. The lack of critical analysis or critical evaluation in the CER cannot be ameliorated by the SLR. There is nothing in the CER or SLR that qualifies as a critical evaluation of the compilation of literature. At hearing,

Dr Haverfield was questioned about the level of critical analysis or evaluation undertaken by him in the preparation of the CER. His response was that he thought that this was part of the summary and that if the “device is safe an analysis is not going to be all that helpful”.[83] Dr Haverfield went on to say that the analysis was “certainly done” and that he thought it was recorded but “maybe not presented”.[84] The response by Dr Haverfield went no way to answering the question or demonstrating the existence of any critical analysis in the documents.
[83] Transcript of proceedings, 22 May 2018, p. 321.
[84] Transcript of proceedings, 22 May 2018, p. 321.
Our conclusion is supported by the evidence of Dr Gallagher. She states in her report dated 8 May 2018, that the CER makes no attempt to quantify or undertake a critical analysis of the clinical evidence to support the intended use and benefits of the Device. She notes that in the statement under “Overview” in the CER, 10 articles are referenced, however she says that there is no attempt at a critical analysis of these articles and that: “there is no differentiation of any of the specific ligaments the TFS is intended to reinforce”.[85] Dr Gallagher further states that:
“While TFS provides a copy of 7 studies where the TFS is used in a clinical setting, there has been no attempt to extract the data on benefits from the studies. There is no attempt to critically analyse the quality of the studies, nor the results. Therefore the benefits of the device are not demonstrated. While there has been an attempt to identify risks in the Scientific Literature Review and the Clinical Evidence Report, there was no specific reference to the TFS. There was no clinical expert involved in the preparation of either report”.[86]
At hearing, Dr Gallagher reiterated under cross-examination that the applicant “…made no attempt to quantify or qualify the benefits in any of these reports, and nor did they… critically analyse the quality of those studies”.[87] We accept this evidence by Dr Gallagher and agree with the conclusion.
[85]          Exhibit R9, Report of Dr Gallagher, dated 8 May 2018, p. 6.
[86]          Exhibit R9, Report of Dr Gallagher, dated 8 May 2018, p. 12.
[87]          Transcript of proceedings, 18 May 2018, p. 274.
We also accept the evidence of Dr Stevenson and Associate Professor Lubowski, which was to the same effect as that given by Dr Gallagher. Dr Stevenson says in his report dated 25 April 2018, that the CER was a “…narrative summary that quotes from selective articles. Based upon the report as written” and he was unable to determine if the results of the articles examined had been presented in an unbiased, objective way.[88] He states that it is his opinion that this did not constitute a critical analysis of the literature. This is consistent with the conclusion we have reached.
[88] Exhibit R8, Report of Dr Stevenson, dated 25 April 2018
As to the use of the Device for colorectal conditions, Associate Professor Lubowski states in his report dated 4 May 2018, “the literature has not provided evidence that the device is effective for colorectal conditions and therefore it is not possible to weigh potential benefits against non-documented risks”.[89] We accept this evidence.
[89] Exhibit R11, Report of Associate Professor Lubowski, dated 4 May 2018.
Essential principle 2
Essential principle 2 refers to “Design and construction of medical devices to conform with safety principles”. Essential principle 2 requires the manufacturer to identify hazards and associated risks; eliminate or reduce those risks; identify foreseeable misuse of the Device and if unable to do so by design or other means, inform the users of the residual risks that may arise due to any shortcomings of the protection measures adopted.
Consistently with this, the Guidelines provide that to demonstrate compliance with essential principle 2:
“The design and construction processes for a medical device need to take account of any foreseeable risks or hazards that may exist, or could be created by the device when it is used as intended by the manufacturer. The design and construction of the device should, wherever possible, eliminate the identified risks or hazards. Where risks or hazards can not be avoided methods must be established to alert and inform users of the medical device”.
… a well-reasoned and documented risk analysis should be developed to demonstrate compliance with Essential Principle 2. It is also important to regularly update the risk analysis of the device to account for changes in knowledge or advances in the field to ensure that the design and construction of the medical device continues to conform to safety principles.
…
The work undertaken by the manufacturer could involve, but is not restricted to:
·a well-reasoned and documented risk analysis
·a documented review of manufacturer’s experience with device
·documented compliance and/or consideration of relevant product safety and performance standards”.[90]
[90] Exhibit R1, The Guidelines, p. 43.
We are not satisfied that TFS had available sufficient information, at all times while the Device was in the Register, to substantiate compliance with essential principle 2 for the following reasons.
As a general proposition, we note that non-compliance with essential principles 14 and

6 virtually precludes compliance with essential principle 2 because the identification of the hazards and risks of a Device is dependent on a clearly defined and consistent intended purpose for the Device; adequate clinical evidence and critical analysis of the available data by a competent expert and a well-reasoned and documented risk analysis. The failure of TFS to adequately identify and articulate the intended purpose of the Device, and to support that with clinical evidence, is a significant impediment to it adequately identifying and managing hazards and risks arising from the intended use of the Device.
Putting that general proposition to one side, we turn to the RMF and the evidence of Dr Gold and Dr Haverfield, on which TFS relies to show that it had available sufficient information to substantiate compliance with essential principle 2. The RMF contains a list of 52 foreseeable hazards associated with the use of the Device. Dr Gold was not involved in the preparation of the RMF in 2014, but was involved in the review process for the 2016 Risk Management File.
At hearing, Dr Haverfield gave evidence that he provided input into the RMF. He accepted that there might be some errors in it; in particular he accepted that there was a hole or gap in the information available as some negative events were never documented as complaints by the manufacturer. This is acknowledged in the RMF:
“While it is acknowledged that some published scientific literature pertaining to the TFS device made reference to problems some surgeons experience with the TFS device, this information was never documented as Post Market feedback and/or considered a complaint at the time - which was an inverted oversight and misinterpretation of the regulatory intent. This oversight has now been addressed, where all experiences as published in scientific literature in the future will be considered Post Market Feedback and managed in accordance with the appropriate procedures and company quality management system.”.[91]
[91] Exhibit R7, T Documents, vol. 1, T36-2, Appendix B: RMF, dated 3 June 2014, p. 255.
The RMF details an “initial summary analysis” of the findings that were cited in the SLR under the heading “Scientific Literature” and provides, inter alia:
·Most common complications are tissue erosion at around 10% of all procedures.
·Of those that present with complications - around 70% of serious complications, suggesting that overall around 5 - 10% of patients get serious complications.[92]
[92] Exhibit R7, T Documents, vol. 1, T36-2, Appendix B: RMF, dated 3 June 2014, p. 255.
There is no explanation contained in the RMF of how the above percentage figures were calculated and there is no reference to the specific data relied upon to support the summary. We accept Dr Haverfield’s evidence that the summary was generic for devices and was not specific to the TFS Device.
We conclude there were shortcomings in “Table 2: Risk Management Worksheet” to the RMF, which includes an evaluation of residual risks. There is no explanation of how the figures were calculated or on which data the figures were based. At hearing, Dr Haverfield was unable to explain how the figures in the Table were calculated. Specifically, his explanation appeared to include reference to the “Cochrane database analysis”, despite it being common ground between the parties that this was not the method used by TFS. When taken to a specific entry in the Table, where the residual risk evaluation was reduced from P4 to P2, Dr Haverfield’s explanation for that reduction was: “I think one relies a lot on clinical evaluation in clinical judgment in the process of literature review.”[93]
[93] Transcript of Proceedings, 22 May 2018, p. 303.
When asked by Mr Hanks about the manner in which the reduction was calculated, Dr Haverfield referred to the passage in which it was stated that:
“All surgeons using the TFS device are trained. They’re given product literature and education. They have direct observation of surgical procedure. They have a one-on-one training and the surgeon will only be accredited when he has reached a certain standard.”[94]
Training is important and the manufacturer will not permit the untrained to use the Device. In that way, the risks, which are identifiable, are known to those who are trained in the use of the Device, Dr Haverfield said, and added:
“… So I think that the user document must document the possible but not to quantify them. This is up to the clinician to be well trained and to be aware of those – that quantification and mitigate against and make the number smaller.”[95]
[94] Transcript of Proceedings, 22 May 2018, p. 303.
[95] Transcript of Proceedings, 22 May 2018, p.305.
Dr Haverfield expressed a similar view regarding risks of urinary retention, dyspareunia and voiding dysfunction that had been identified in the literature, but were not identified in the RMF and further risks that had been identified in the Instructions for Use dated April 2014[96] that referred to potential surgical complications that were not identified in the RMF. He said:
“… Risks, Mr Hanks, an identification of them is the responsibility of the training surgeon, and obviously for the instructions of use it’s covered here. I’m sure that all we needed to say here was to say that, please, sir, read the instructions for use and integrate that into the risk management file.”[97]
[96]Exhibit R7, T Documents, vol. 1, T12-6, Instructions for Use document for the Device, p. 78.
[97] Transcript of Proceedings, 22 May 2018, p. 299.
A difficulty with Dr Haverfield’s approach is that it does not permit or contemplate either an identification of risk or a quantification of that risk based on objective factors. There is no evidence that this was done. We prefer and accept Dr Gallagher’s evidence to the effect that the CER and SLR failed to “identify, quantify and address all the risks associated with the use of the TFS Device”.[98] We conclude from her evidence that the CER excluded known adverse events and risks that were identified in the literature provided on TFS. She considered that “the data is not sufficient to quantify the risks of the TFS nor to support the safety of the TFS given the paucity of specific TFS related evidence”.[99]

We agree with this conclusion.
[98] Exhibit R9, Report of Dr Gallagher, dated 8 May 2018, p. 8.
[99] Exhibit R9, Report of Dr Gallagher, dated 8 May 2018, p. 7.
Associate Professor Lubowski expressed the opinion in his report dated 4 May 2018, that with regard to the use of the Device for colorectal conditions, the clinical risks associated with symptoms of faecal incontinence and obstructive defecation have not been assessed in the RMF. He also says that those risks had not been addressed because faecal incontinence had not been assessed accurately in TFS’s literature or compilation. We agree with those conclusions.
Therefore, we conclude that the information does not meet the requirements of essential principle 14 to demonstrate that the Device complies with the requirements of essential principle 2 as to the need to identify hazards and associated risks arising from the use of the Device for its intended purpose (or any foreseeable misuse).
Dr Gallagher states in her report dated 8 May 2018, that the RMF does not sufficiently address any of the generally recognised surgical complications for incontinence procedures, prolapse procedures and transvaginal mesh procedures. She further states that the three different trocar designs and the reason for selection of one over the other is “surgeon preference”.[100] She notes that:
“There is no description of the advantages or disadvantages in each design, or reasons given why one would be chosen over another, or whether the different links or angles of each would carry different risks. As one of the risk reduction measures is placement of the anchors in the correct issues, the advantages of risks associated with the use of each of the different trocars should be better specified than just surgeon preference”.[101]
Dr Gallagher further states in her report that the lack of definition for “high risk” factors in the patient population is ill-defined and the RMF does not adequately deal with the risks of implanting the device into unsuitable patients. We accept Dr Gallagher’s evidence as to these issues.
[100] Exhibit R9, Report of Dr Gallagher, dated 8 May 2018, p. 9.
[101] Exhibit R9, Report of Dr Gallagher, dated 8 May 2018, p. 9.

As to alerting and informing users of the Device about any foreseeable risks and hazards, Dr Gallagher says in her report dated 8 May 2018, that the Instructions for Use are brief and not comprehensive. She explains that it does not:
“…specifically address ways of mitigating or reducing the identifiable risks associated with insertion of the mesh and short and long-term complications or adverse events.The contraindications are generalised (e.g.: poor or atrophied tissues), and there is no comprehensive or specific instructions on how to reduce these with preoperative counselling, patient selection, intraoperative warnings and postoperative care”.[102]
Dr Gallagher states that the Instructions for Use, “…fail to identify many of the well known risks and complications associated with transvaginal mesh use”.[103]
[102] Exhibit R9, Report of Dr Gallagher, dated 8 May 2018, p. 11.
[103] Exhibit R9, Report of Dr Gallagher, dated 8 May 2018, pp. 11 – 12,
In response to the evidence of Dr Gallagher, Dr Gold states in his report dated

14 May 2018, that the choice of which trocar to use is:
“…generally… up to the surgeon to decide and cannot be prescribed. It isn’t an operative decision... It is a matter of judgement. Any attempt to be prescriptive about this would build in more error than it removes”.[104]
The other criticisms identified by Dr Gallagher in the RMF, regarding the lack of specificity and identification of potential risks and hazards with the use of the Device, are largely unmet, however, Dr Gold does state that he does not consider it necessary for more information about complications to be included in the Instructions for Use as this information would be known to any clinician using the Device.
[104] Exhibit A11, Report of Dr Gold, dated 18 April 2018.
Dr Gold’s position is essentially the same as that adopted by Dr Haverfield. Even if it is accepted that the risks will be known to those to whom the manufacturer sells the Device and so are persons whom the manufacturer is satisfied have been appropriately trained, that will not satisfy the requirements of essential principle 2 in the context of the regulatory scheme provided in the Act and the Regulations. As we have said, the scheme is, in the first instance at least, a self-regulatory scheme that depends on the person who seeks to have the Device placed in the Register, having sufficient information to substantiate compliance with the essential principles. Registration is a key element in ensuring that devices meet appropriate standards. Having sufficient information to substantiate compliance with the essential principles enables a judgment to be made as to whether they do comply. Simply relying on training given to those who use the Device and on their professional judgment, does not, as required by essential principle 2, identify the hazards and associated risks arising from the use of the Device for its intended purpose, as well as for any foreseeable misuse of the Device or eliminate or reduce those risks. Furthermore, training and professional judgment do not satisfy the requirement to have sufficient information to substantiate compliance with the requirement to inform users of any residual risks that may arise due to any shortcomings of the protection measures adopted.
Due to the deficiencies in the CER, SLR and RMF, as discussed above, we are not satisfied that TFS had available sufficient information to substantiate compliance with essential principle 2 during the relevant period. On the information available, all hazards, associated risks and foreseeable misuse of the Device were not adequately identified by TFS. We are also not satisfied, on the information that TFS had available in the period during which the Device was included in the Register, that users of the Device were appropriately informed of the hazards and residual risks. This is demonstrated by the Instructions for Use for the Device, which is not comprehensive and fails to identify many of the risks and complications associated with the use (or misuse) of the Device It follows that at all times during the time the Device was in the Register, TFS did not have sufficient information available to substantiate compliance with essential principle 2.
Essential principle 6
Essential principle 6 requires that the benefits to be gained from the use of the device must outweigh the undesirable effects arising from its use. At the relevant time, the Guidelines consistently provide:
“To comply with this Essential Principle it is necessary, as part of a well-reasoned risk analysis, to identify and document any undesirable effects from using the device and compare these with the benefits expected to be achieved through the use of the device.
In addition to the risk analysis, manufacturers should provide evidence that the outcomes or conclusions of the risk analysis have been acted on.
The work undertaken by the manufacturer could involve, but is not restricted to:
·a well-reasoned and documented risk analysis
·a documented review of the manufacturer’s experience with device”.[105]
[105] Exhibit R1, The Guidelines, p. 45.
Lack of compliance with essential principles 14 and 2, as described above in these reasons, adversely effects compliance with essential principle 6, to the extent that we cannot be satisfied that essential principle 6 has been complied with, because TFS has not demonstrated that the benefits to be gained from the use of the Device outweigh the undesirable effects arising from its use through a well-reasoned, documented and objective analysis. Without a comprehensive literature review, without sufficient clinical evidence and objective critical analysis of the available data, including an adequate identification of the hazards and associated risks, any conclusion reached by TFS in regards to the benefits expected to be achieved through the use of the Device outweighing any undesirable effects from using the Device is unsubstantiated.
TFS contends that on the basis of the referenced material contained in the CER, the benefits clearly outweigh the undesirable effects in respect of stress urinary incontinence and vaginal prolapse. The failure of the CER to adequately identify the hazards and associated risks is addressed above in these reasons. We do not accept that merely referencing literature is sufficient to demonstrate that the benefits expected to be achieved from the use of the Device outweigh any undesirable effects arising from its use. The CER does not include any analysis or critical evaluation of the material. As to the benefits, the CER does not include a critical analysis of the clinical evidence to support the intended use and benefits of the Device. The broad conclusions reached in the CER are references to published literature containing results of studies. However, as we have earlier decided, there is no critical evaluation contained in a report by an expert.
In regards to the use of the device for colorectal conditions, Associate Professor Lubowski’s evidence was that neither the CER nor the SLR complied with essential principle 6, in that the referenced literature did not provide evidence that the Device was effective for colorectal conditions and as such it was not possible to weigh up the potential benefits against known risks. TFS acknowledges this deficiency. We accept this evidence.
TFS has not demonstrated that the benefits to be gained from the use of the Device outweigh any undesirable effects through a well-reasoned, documented risk analysis.

We are not satisfied that, at all times while the device was in the Register, TFS had available sufficient information to substantiate compliance with essential principle 6.
SHOULD THE ENTRY OF THE DEVICE IN THE REGISTER BE CANCELLED?
For the reasons we have given, we have concluded that TFS failed to comply with the condition outlined in s 41FN(3)(a)(i) of the Act. At all times while the inclusion of the Device in the Register had affect, TFS did not have available sufficient information to substantiate compliance with essential principles 2, 6 and 14 as set out in Schedule 1 of the Regulations. Cancellation is not an automatic consequence flowing from our conclusion on these matters and we now turn to whether the entry of the Device in the Register should be cancelled or suspended or whether the cancellation decision should be set aside and the Device entered in the Register either with or without conditions.
The legislation
The relevant legislative power under which the Secretary may cancel the entry of a kind of device from the Register after giving a written notice to the person in relation to whom it is included in that Register is found in s 41GN(1)(b). The relevant power arises when:
“the person in relation to whom the kind of medical device is included in the Register refuses or fails to comply with a condition to which that inclusion is subject.”
The Secretary is given power to suspend a kind of medical device in the Register in the circumstances set out in s 41GA. Section 41GA(1)(b) gives the Secretary power to suspend the kind of device in the Register after giving written notice to the person in relation to whom it is included in the Register if “… satisfied that it is likely that there are grounds for cancelling the entry of the kind of device in the Register under Division 2 (other than under paragraph 41GL(a), (d) or (f) or section 41GM).” The period of suspension must not exceed six months.[106] The period of suspension provided for under

s 41GA(3) may be extended under s 41GC(3), which provides:
“If a person in relation to whom a kind of medical device is included in the Register shows that he or she has taken steps to remove the grounds for cancelling the entry of the kind of device from the Register under section 41GN, the Secretary may, by written notice given to the person, extend the period specified in the notice under section 41GA(1) by a further specified period not exceeding 6 months.”
[106] s 41GA(3), the Act.
Section 41GD(1) provides that the Secretary must revoke the suspension if satisfied that:
“(a)the ground on which the kind of medical device concerned was suspended from the Register no longer applies; and
(b)there are no other grounds for suspending the kind of device from the Register.”
Section 41FP provides that the Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, impose new conditions on including the kind of device in the Register or vary or remove existing conditions.
Consideration
On behalf of the applicant, Mr Harris submitted that the Minister did not conclude that the Device is not safe to use. He submitted that all which had been decided was that the applicant’s documentation was inadequate to demonstrate compliance with the essential principles. Mr Harris went on to submit that, it is not a case about safety and efficacy of the Device.[107] The purpose of the Act is to provide a system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods if used as intended.[108] Where there are no known problems with quality, safety or efficacy, then the focus of the decision-maker must be to ensure availability of goods that benefit patients. That approach, Mr Harris continued, gives effect to the policy of the Act. In the absence of known problems with quality, safety and efficacy, cancellation of the entry of the Device in the Register should be a last resort.[109] Suspension takes priority over cancellation, and that is reflected in its placement in the Act. Where a person has taken steps to remove the grounds justifying cancellation, the Secretary, and so the Minister, should consider suspension, Mr Harris submitted.[110] This was the case with the applicant. The TGA itself had acknowledged that the documentation presented in 2014 was of a significantly higher quality than that which it had initially reviewed. Correspondence between the TGA and the applicant since then has shown the applicant’s continual and timely efforts to give the TGA what it originally sought.[111]
[107]         Applicant’s Outline of Closing Submissions at para [9.2.26], p. 97.
[108]         Applicant’s Outline of Closing Submissions at para [9.2.27], p. 97.
[109]         Applicant’s Outline of Closing Submissions at para [9.2.28], p. 97.
[110]         Applicant’s Outline of Closing Submissions at paras [9.2.30] - [9.2.32], pp. 97 – 98.
[111]         Applicant’s Outline of Closing Submissions at [9.2.34] - [9.2.39], pp. 98 – 99.
In this case, Mr Harris submitted, suspension is no longer a practical option. He submitted that it is now appropriate to set aside the cancellation altogether without further ado. If that was not considered an appropriate decision, Mr Harris submitted, we should consider a decision setting aside the cancellation decision and substituting a decision that the Device be entered in the Register but subject to conditions imposed under s 41FP of the Act.[112]
[112] Applicant’s Outline of Closing Submissions at [9.2.40] - [9.2.41], pp. 99 – 100.
We agree that suspension is no longer a practical solution. Had it been so when the decision was made, a suspension could have remained in place for a period of only six months unless extended by a further six months under s 41GC(3). On the facts that we have found, there would have been no grounds for an extension as the applicant did not show in the first six month period that it had taken steps to rectify the grounds for cancelling the entry of the kind of device from the Register under s 41GN i.e. failing to have sufficient information to comply with essential principles 2, 6 and 14.
Although we recognise that the Secretary could have imposed conditions on registration, we have come to the view that cancellation was the correct decision. An examination of the documents admitted in evidence in this matter, show that the matter has a long history. The Device was chosen to undergo a post market review due to concerns that had been raised with the TGA relating to the surgical implications of not being able to image the implanted device. The TGA asked for post market data, reports on adverse events relating to the Device both in Australia and overseas, all complaint reports for the issue both in Australia and overseas and information on any product improvements undertaken on the Device since 2005 or any improvements proposed by the manufacturer. The TGA’s letter was dated 23 November 2009.[113] Correspondence continued between the applicant and the TGA, which requested information in a letter dated 25 September 2013.[114] In each instance, the requests were made under s 41JA of the Act. The applicant’s response on 18 October 2013 was to provide five papers but did not provide any clinical evaluation as required by the clinical evaluation procedures. Its earlier responses had not revealed such information. The communications between the applicant and the TGA culminated in the decision that the conditions had not been met a year or so later and we have come to the same conclusion a further four years later.
[113]Exhibit R7, T Documents, vol. 1, T5, Post Market Review Request letter from TGA to TFS, dated 23 November, pp. 29 – 31.
[114]Exhibit R7, T Documents, vol, T24, Notice requiring information from TGA to TFS, dated 25 September 2013, pp. 114 – 120.
The failure of TFS to comply with the condition imposed by s 41FN(3)(a) to have available sufficient information to substantiate compliance with essential principles 2, 6 and

14 during the relevant period is not a minor or trivial matter. Demonstrated compliance with the essential principles is an integral part of the scheme of regulation established by the Act and the Regulations. For the reasons we have given earlier, the scheme is, in part, a self-regulation scheme. It depends on the person in relation to whom the kind of device is included in the Register having sufficient information to substantiate compliance with the essential principles or having procedures in place to ensure that such information can be obtained from the manufacturer within a specified period. That information then becomes available to the TGA, should it exercise its powers of audit. Its availability, whether from the person in relation to whom the kind of device is included in the Register or from the manufacturer, and its currency is essential in those circumstances, in giving the TGA and the Australian community a measure of confidence in the regulatory scheme that is directed to ensuring the quality, safety and performance of any kind of medical device that is entered in the Register. This is consistent with s 4(1)(a) of the Act when it provides that:
“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;…”
Finally, we would note that it is not relevant to the scheme of regulation established by the Act and Regulations and applying in these circumstances that the Device has been registered in Europe or elsewhere beyond Australia. We are limited by the Act and the Regulations and their terms. Although it is apparent from the Guidelines that there are similarities between the schemes of regulation in Australia and in the European Union,

s 8 of the Guidelines also makes it clear that there are differences, and that one of those differences is that there is no longer an equivalent to essential principle 14.[115]
[115] Exhibit R1, The Guidelines, p. 152.
DECISION
For the reasons we have given, the decision dated 1 October 2014 to cancel the entry of the Device in the Register under s 41GN(1)(b) and affirmed by a delegate of the Minister on 27 February 2015 is affirmed.

I certify that the preceding 111 (one hundred and eleven) paragraphs are a true copy of the reasons for the decision herein of Justice D G Thomas, President, Deputy President S A Forgie, Senior Member A Poljak

...............................[Sgd].........................................
Associate
Dated: 29 November 2018

Dates of hearing: 16, 17, 18 and 22 May 2018 and 22 June 2018

Counsel for the Applicant: Mr Andrew Harris QC

Solicitors for the Applicant: Cosoff Cudmore Knox

Counsel for the Respondent: Mr Peter Hanks QC with Ms Kathleen Foley

Solicitors for the Respondent: Minister for Health

[2018] AATA 4456

29 November 2018

Key Legal Topics

Areas of Law

Administrative Law

Statutory Interpretation

Legal Concepts

Judicial Review

Procedural Fairness

Standing

Statutory Construction

Remedies

Jurisdiction

Dates of hearing:	16, 17, 18 and 22 May 2018 and 22 June 2018
Counsel for the Applicant:	Mr Andrew Harris QC
Solicitors for the Applicant:	Cosoff Cudmore Knox
Counsel for the Respondent:	Mr Peter Hanks QC with Ms Kathleen Foley
Solicitors for the Respondent:	Minister for Health