PYRAMED PTY LTD and MINISTER FOR HEALTH AND AGING
[2012] AATA 197
•4 April 2012
[2012] AATA 197
Division GENERAL ADMINISTRATIVE DIVISION File Number(s)
2012/1068
Re
PYRAMED PTY LTD
APPLICANT
And
MINISTER FOR HEALTH AND AGING
RESPONDENT
DECISION
Tribunal MR S. WEBB, MEMBER
DR B. HUGHSON, MEMBERDate 4 APRIL 2012 Place Canberra Operation of the decision to cancel registration of the Guideliner Catheter is stayed for the duration of these proceedings, subject to further order. The matter is to be expeditiously progressed to hearing.
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MR S. WEBB, MEMBER
Catchwords
PRACTICE AND PROCEDURE – stay application – cancellation of registration of cardiovascular medical device – classification rules – interests of affected persons – public interest – safety and satisfactory performance - risk – relevant considerations – interim stay granted – stay extended
Legislation
Administrative Appeals Tribunal Act 1975 s 41
Therapeutic Goods Administration Act 1989 ss 41FD, 41FF, 41FH, 41GN
Therapeutic Goods (Medical Devices) Regulations 2002 Schedule 2REASONS FOR DECISION
MR S. WEBB, MEMBER
DR B. HUGHSON, MEMBER4 APRIL 2012
Pyramed Pty Ltd applied for inclusion of an intravascular guiding catheter, the Guideliner Catheter (Guideliner), in the Australian Register of Therapeutic Goods. The Guideliner is a medical device used in conjunction with a guide catheter in coronary and peripheral blood vessels. Pyramed certified that the Guideliner was a Class IIa device under the regulatory classification scheme for medical devices. Registration was refused by primary determination and on reconsideration. The matter came before the Tribunal. The proceedings were resolved by consent, without a hearing, and the Guideliner was registered as a Class IIa device.
Subsequently, the Secretary of the Department of Health and Ageing decided to cancel the Guideliner’s registration on the basis that the certification provided by Pyramed was not correct. On 20 March 2012 this decision was affirmed by a delegate of the Minister for Health and Ageing[1]. Pyramed applied for review. Additionally, Pyramed made application for the operation of the decision to be stayed. The stay application was resisted by the Minister.
[1] Exhibit 3, Attachment 10.
On 23 March 2012, I made orders granting an interim stay until close of business on 5 April 2012 in order to allow the parties to properly marshal evidence and prepare submissions for a substantive stay hearing. Presently, having heard the parties and received a number of documents into evidence, it is this stay application that we must determine.
The power to make orders staying or otherwise affecting the operation or implementation of the decision under review under s 41(2) of the Administrative Appeals Tribunal Act 1975 (Cth) is discretionary. If it is desirable to do so, the Tribunal may issue such orders as it considers appropriate for the purpose of securing the effectiveness of the hearing and determination of the application for review. When considering these matters, it is necessary to take into account –
(a)Pyramed’s prospects for success;
(b)the consequence for each party if a stay is not granted;
(c)the interests of any persons who may be affected by the review;
(d)the public interest;
(e)whether the review would be rendered nugatory if a stay is not granted; and
(f)other relevant matters, including the length of time the Guideliner has been registered and the time required to hear and dispose of the application.
Attention was drawn to a number of cases in the course of submissions[2] and during the interlocutory hearing[3]. We have carefully considered those cases, but it is not necessary to refer to them further.
[2] Hidayettin Yolbir v Administrative Appeals Tribunal and Secretary, Department of Social Security [1994] FCA 910; Re Australian Telecommunications Corporation v Daniel Moffat [1992] FCA 27; Re Commissioner for Superannuation and Hastings (1986) 5 AAR 197; Re Josip Dekanic and Tax Agents' Board of New South Wales [1982] AATA 195; Re Commonwealth Banking Corporation and Robert Anthony Iannello [1988] AATA 173; Ingham and Secretary, Department of Families, Housing, Community Services and Indigenous Affairs [2010] AATA 1068; Re Secretary, Department of Social Security and Juliet Stolper [1991] AATA 307; Pfizer Pty Ltd v Birkett [2001] FCA 828.
[3] Ego Pharmaceuticals Pty Ltd and Minister for health and Ageing [2010] AATA 825; Eli Lilly Australia Pty Ltd and Minister for Health and Family Services [1999] AATA 565
Prospects for success
In the course of the stay hearing, the parties agreed, correctly, that the substantive matter turns on an issue of statutory construction. At the heart, the issue concerns the interpretation of the classification rules for medical devices set out in the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth), specifically clauses 3.2(3) and 3.3(4) of Part 3, Schedule 2 –
3.2 Surgically invasive medical devices intended for transient use
(1)This clause applies to a surgically invasive medical device that is intended for transient use.
(2)Subject to subclauses (3) to (5), the device is classified as Class IIa.
(3)If the device is intended by the manufacturer specifically to be used to diagnose, monitor, control or correct a defect of the heart, or the central circulatory system, of a patient through direct contact with these parts of the body, the device is classified as Class III.
…
3.3 Surgically invasive medical devices intended for short‑term use
(1)This clause applies to a surgically invasive medical device that is intended for short‑term use.
(2)Subject to subclauses (3) and (4), the device is classified as Class IIa.
…
(4)If the device is intended by the manufacturer:
(a)specifically to be used to diagnose, monitor, control or correct a defect of the heart, or the central circulatory system, of a patient through direct contact with these parts of the body; or
(b)specifically to be used in direct contact with the central nervous system of a patient; or
(c)to have a biological effect; or
(d)to be wholly, or mostly, absorbed by a patient’s body;
the device is classified as Class III.
…
Pyramed was not clear in its submission about whether the Guideliner is for ‘transient’ or ‘”short-term” use. It appears that agreement may be reached that the device is for short-term use. For present purposes this difference is not material as the statutory tests in clauses 3.2(3) and 3.3(4)(a) are the same.
The present evidence does not provide a robust basis for detailed fact finding in relation to the use and classification of the Guideliner in Australia, or in other jurisdictions applying harmonised classification rules in respect of medical devices.
Pyramed filed extensive submissions attaching various documents on which it relies. Additional materials were tendered in evidence by the Minister. These items were exhibited and labelled.
Pyramed acceded to the accuracy of the description of the Guideliner (with the exception of the sixth dot point) set out in the decision of Linda Punyer, the Minister’s delegate[4]. We note the unchallenged evidence of Dr Guy Wright-Smith at Attachments 5 and 7 of Pyramed’s submissions and the manufacturer’s description set out in Exhibit 4. Considering these materials it is clear that the Guideliner is intended for use with a guide catheter and, in effect, extends and supports the guide catheter when accessing damaged or tortuous vessels. There is a dispute about the significance of the Guideliner coming into direct contact with the heart or parts of the central circulatory system. For present purposes we do not need to resolve this point. It is sufficient to observe that devices that come into direct contact with such body parts appear to have been registered as Class IIa and Class III devices. The issue will arise in the substantive hearing.
[4] Exhibit 1, Attachment 2 and replicated in paragraph 117; Exhibit 2, Attachment 10.
There is conflicting evidence concerning the classification of cardiovascular catheters in Australia that have similar characteristics and intended uses to the Guideliner. On the one hand, the evidence of Andrea Kunca, an employee of the Therapeutic Goods Administration, and (apparently) Linda Punyer is that:
the Class IIa cardiovascular catheters and cannulas ARTG [Australian Register of Therapeutic Goods] entries that appear to be used in the central circulatory system have been targeted for post-market review.[5]
This suggests that, subject to review, some cardiovascular catheters and cannulas have been and may presently be registered as Class IIa devices. On the other hand, Ms Kunca’s evidence suggests that 41 cardiovascular catheter and cannula devices have been registered as Class IIa devices.[6]
[5] Exhibit 2, paragraph 39.
[6] Exhibit 2, Attachment 8, page 6; see also paragraph 34 and Attachment 7.
The evidence concerning the registration and classification of the Guideliner suggests that it was included on 4 March 2011 as a Class IIa device on certification of Pyramed, even though the TGA did not accept or agree with the certification[7]. It appears that the TGA accepted that the requirements of s 41FF and 41FD of the Therapeutic Goods Administration Act 1989 (Cth) (TGA Act) were satisfied and, at that time, the application had not been selected under s 41FH for audit. On 8 March 2011 the TGA informed Pyramed that the inclusion of the Guideliner in the Australian Register of Therapeutic Goods “has been selected for a post market targeted review to verify the certifications made by [Pyramed]… are true and correct”[8]. It is not necessary for us to resolve the dispute about whether the TGA acted in good faith when it settled the earlier Tribunal proceedings by consent.
[7] Exhibit 2, paragraph 25 and Attachment 1.
[8] Exhibit 2, paragraph 27.
Of greater relevance, is the evidence concerning the earlier registration in Australia on 21 February 2007 of an intravascular guiding catheter pursuant to an application brought by Pyramed.[9] This device was said to be intended for use in relation to the peripheral arterial vasculature[10] and it was included as a Class IIa device. Whether this device and the Guideliner have similar characteristics or intended uses we are not able to determine on the present evidence, although it appears unlikely. There is no evidence to support Pyramed’s assertion that the Guideliner was registered under another name prior to March 2011.
[9] Exhibit 2, paragraph 43 and Attachment 11.
[10] Exhibit 2, Attachment 11, page 3
We note the extracts of the Australian Regulatory Guidelines for Medical Devices and the comparable European Commission Guidelines[11] in Exhibit 5.
[11] European Commission, Guidelines relating to the Application of Council Directive 93/42/EEC on Medical Devices - MEDDEV 2.4/1 Rev.9, June 2010.
There is conflicting evidence concerning the classification of cardiovascular catheters and the Guideliner under the harmonized regulatory classification arrangements in Europe and other jurisdictions. The European Commission Guidelines in respect of Rules 6 and 7 provide cardiovascular catheters as examples of devices at the Class III level. The evidence of Dr Wright-Smith is that “[t]he Guideliner catheter is currently available in Europe and USA and has been registered as a Class II device”[12]. There is evidence that on 9 August 2006 certain dual access catheters, the “Twin Pass Catheter” and the “Skyway Catheter” manufactured by Vascular Solutions (USA), the manufacturer of the Guideliner, were registered on as Class IIa devices under the European Commission harmonized rules[13]. We are not able to go further on the present evidence.
[12] Exhibit 1, Attachment 5, page 1.
[13] Council Directive 93/42/EEC (MDD).
In sum on this point, the statutory construction point lies open. The present evidence does not suggest that Pyramed has no prospect of succeeding.
Consequences for each party
On the evidence of Patrick Hegarty, director and founder of Pyramed, the company “cannot afford to bear the losses arising from the removal of the GuideLiner from the market during the appeal process”[14]. No evidence concerning the financial position of the company or the losses that may be incurred if a stay is not granted has been adduced.
[14] Exhibit 1, Attachment 1, paragraph 5.
Even so, the proposition that Pyramed will suffer financial losses if a stay is not granted can be accepted even though the extent of any such losses cannot be quantified on the present evidence. Mr Hegarty’s unchallenged evidence is that 500 Guideliner devices have been sold to 58 cardiology catheterisation laboratories and the potential exists for the Guideliner device to be used in up to 2,000 cases each year. This business will cease for the duration of these proceedings, at least, if a stay is not granted.
The TGA was silent about any consequences it may face in respect of standards, functions, procedures or other matters if a stay is granted.
Interests of persons who may be affected by the review
Persons who may be affected by the review include medical professionals who use the Guideliner in practice and patients undergoing operations in which the device is used. There is only scant evidence concerning the interests of these people.
Mr Hegarty’s evidence is that:
If the stay is not granted the sponsor [Pyramed] may have little choice but to permanently withdraw the GuideLiner from the market [and this]… will have an adverse knock-on effect on the availability of the device in both emergency and chronic cardiac cases, causing unnecessary patient suffering and exposure to increased surgical risk.[15]
There are a number of things to say about this evidence.
[15] Exhibit 1, Attachment 1, paragraphs 7 and 9.
On Mr Hegarty’s evidence the prospect of withdrawal of the Guideliner from the Australian market if a stay is not granted is no more than a possibility.
The proposition that patients may be adversely affected is supported by Dr Wright-Smith’s evidence, albeit brief – the Guideliner facilitates angioplasty and improves patient outcomes and safety, and if it is not available for use in Australia it would be “a great tragedy for patients undergoing angioplasty”[16]. It can be accepted that if the Guideliner is the device of choice in certain complex procedures, as the evidence of Dr Wright-Smith suggests, patients and medical professionals may be adversely affected if it is not available for use and no alternative device of equivalent efficacy is available. There is no persuasive evidence that an alternative device with the same function and efficacy is available in Australia.
[16] Exhibit 1, Attachment 5, page 2.
It follows that patients and medical professional are likely to be adversely affected if a stay is not granted.
Public interest
The TGA submitted that there are unquantified and unassessed risks to patients undergoing medical procedures in which the Guideliner is used.
There is a powerful public interest in the regulation of medical devices on the basis of risks to public health and safety, as codified in the classification rules. And the Guideliner has not yet, properly, been assessed as a Class III device that may be used in procedures to diagnose, monitor, control or correct a defect of the heart, or the central circulatory system, of a patient through direct contact with these parts of the body. Whether an assessment of that kind is necessary, however, has not yet been determined with finality. This will depend upon the classification of the device and the resolution of the statutory construction issue that is at the heart of these proceedings.
In the TGA’s submission these public interest considerations extend to include medical professionals using the Guideliner who rely on the medical devices classification scheme for assurance that the device is safe to use in high risk procedures involving the central circulatory system and the heart. Clearly, any failure of the Guideliner in a procedure of this kind may have catastrophic effects for the patient.
It is clear that the Guideliner has been registered for use in Australia as a Class IIa device by the TGA since March 2011. No evidence was adduced, and no point was taken or pressed, about safety concerns relating to use of the device during this period. There is no evidence sufficient to establish that the safety or performance of the device is unacceptable for the purposes of s 41GN of the TGA Act.
The issue pressed by the Minister turns on the statutory codification of a hierarchy of risk in the classification rules and the associated quality assurance and documentation requirements in respect of design and manufacture. Nevertheless, on Ms Kunca’s evidence there are some 41 cardiovascular catheters and cannulas registered as Class IIa devices. With this in mind, it appears to us that the public health safety risk associated with the registration of cardiovascular catheters and cannulas as Class IIa devices is unlikely to be significantly affected whether or not a stay is granted. On the present evidence, no different conclusion is made out with respect to the Guideliner.
Nevertheless, this point serves to underline the desirability of progressing the matter expeditiously to hearing.
Review rendered nugatory
Pyramed asserts that the review would be rendered nugatory or pointless if a stay is not granted for the simple reason that the Guideliner would be withdrawn from the Australian market and the proceedings would be brought to a premature end.
If Mr Hegarty’s evidence concerning that possibility were accepted as probable or as a certainty, the submission would have much force. But this is not presently established.
Nevertheless, if a stay is not granted, even if Pyramed were to succeed at hearing on the statutory construction point, it could not be returned to the position it which it stood immediately prior to the decision to cancel registration of the Guideliner. As we have said, even though not quantified, there are likely to be adverse financial implications for Pyramed. Furthermore, it is conceivable that Pyramed’s market penetration with this device in Australia, having supplied 500 devices to 58 cardiology catheterisation laboratories, may also be adversely affected – but no evidence concerning market variables or related matters was adduced; this was not squarely raised and it is not presently established.
Even though financial or hardship considerations, alone, are not likely to be determinative of the issue we must decide, it can be accepted that they are factors that bear upon Mr Hegarty’s interest in proceeding.
While the review would not be rendered nugatory without grant of a stay, the effectiveness of the hearing and the determination of the application for review would be narrowed.
Other relevant matters
There are two matters of timing that are relevant to consider.
The Guideliner has been registered for use in Australia as a Class IIa device from 4 March 2011. It is likely that other cardiovascular catheters have been registered in this class for longer periods. The grant of a stay will permit registration of the Guideliner as a Class IIa device to continue during the period required for the proper conduct of these proceedings.
The period required to conclude these proceedings is a matter of importance therefore. The parties have indicated their concurrence with variation of usual Tribunal procedures, involving conferences and alternative dispute resolution, in order to progress the matter efficiently to hearing. Furthermore, it has been agreed that efforts will be made to reach agreement on matters of evidence and fact in order to facilitate progress and reduce the time required prior to hearing.
These are arrangements of good sense and practicality that can be expected to reduce the time required to conclude these proceedings. Even so, a number of months may be required. With the agreement of the parties, a directions hearing is to be listed at 9am on 12 April 2012 to set a timetable for evidence and the filing of an agreed statement of facts prior to the listing of a hearing at the earliest convenient date. On this basis, it is reasonable to expect that a hearing may be possible within three months, although a further period may be required to finalise the decision.
Conclusion and orders
In sum, we are satisfied that it is desirable, having taken into account relevant matters and considerations, to extend the interim stay over operation of the Minister’s 20 March 2012 decision to cancel registration of the Guideliner for the duration of these proceedings, or until further order of the Tribunal. It is appropriate to do so, in the circumstances and on the balance of convenience, to secure the effectiveness of the hearing and the determination of the application.
That said, the application is to be progressed expeditiously to hearing.
42. I certify that the preceding 41 (forty one) paragraphs are a true copy of the reasons for the decision herein of MR S. WEBB, MEMBER.
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Associate
Dated 4 APRIL 2012
Date of interlocutory hearing 3 April 2012
Date of Decision 4 April 2012
Advocate for the Applicant Mr Doug Kentwell, Regulatory Solutions
Counsel for the Applicant Mr Allan Anforth
Solicitor for the Respondent Ms Alice McCormick, Minter Ellison
Counsel for the Respondent Mr Chris Erskine
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