Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing
[2012] AATA 376
•20 June 2012
[2012] AATA 376
Division GENERAL ADMINISTRATIVE DIVISION File Number(s)
2012/0348 & 0350
Re
Aspen Pharmacare Australia Pty Ltd
APPLICANT
And
Minister for Health and Ageing
RESPONDENT
Decision
Tribunal Justice D Kerr, President
Dr T Nicoletti, MemberDate 20 June 2012 Date of written reasons 21 June 2012 Place Sydney The Tribunal orders that:
The decisions under review be remitted to the Respondent for reconsideration pursuant to section 42D of the Administrative Appeals Tribunal Act 1975.
The period within which the Respondent is to reconsider the decisions under review is the period of 56 days, beginning on the date of these orders.
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Justice D Kerr, President
Catchwords
Cancellation of registration of products containing dextropropoxyphene (DPP) – Whether quality, safety or efficacy is unacceptable within meaning of the Therapeutic Goods Act – Decision under review remitted to the Minister for Health and Ageing for further consideration. Order staying the operation or implementation of the decision so remitted ‘until further order’ – Whether the Tribunal remains seized of the proceeding when remitted under section 42D – Stay remains in force.
Legislation
Administrative Appeals Tribunal Act 1975, Sections 41(2), 42D(3), (4), (8), 43AA
Cases
Yolbir v Administrative Appeals Tribunal (1994) 48 FCR 246
Civil Aviation Safety Authority v Hotop (2005) 145 FCR 232
WorldAudio Ltd v Australian Communications Media Authority (2006) 194 FCR 462
REASONS FOR DECISION
Justice D Kerr, President
Dr T Nicoletti, Member21 June 2012
On 15 June 2012, the Tribunal published its reasons for taking the view that it would hear counsel as to the remittal of this matter, pursuant to section 42D of the Administrative Appeals Tribunal Act 1975 (the Act), to the delegate of the Minister for reconsideration. Our intended approach, subject to submissions, was as set out in paragraph 103 of Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362.
In response, Mr Lloyd SC for the Applicant submitted that there were three possible ways in which the Tribunal could address the conclusions that it had drawn.
The first would be to simply allow a period where there would be informal negotiations between the parties, rather than make a formal remittal under section 42D of the Act.
That was Mr Lloyd’s preferred position. He submitted that it would permit the opportunity for discussion between the parties, avoiding any possibility that the Respondent might make announcements flowing from such a remittal which might confuse the market.
The second option was that the Tribunal might set aside the decision and substitute another decision on conditions. Mr Lloyd SC indicated that neither party thought that that was an appropriate course to follow.
The third option was that which had been identified by the Tribunal.
The Applicant indicated that there was agreement between the parties that if that option was followed then instead of the default 28 day period, the Tribunal should substitute a longer period where 56 days would be allowed for a decision to be reached.
Dr Renwick SC for the Minister submitted that the approach foreshadowed by the Tribunal was appropriate.
The concern expressed by Mr Lloyd SC in relation to that proposal was that there could be some risk that a decision would be announced by the Minister through the course of such proceedings which might, in some manner, prejudice the Applicant. However, the Tribunal is not able to identify any significant prejudice that would be likely in those circumstances.
Both sides agree that the Tribunal’s power to continue a stay exists and that the stay in the present proceedings, that is currently in place ‘until further order’, would not be vitiated by its exercise of power under section 42D of the Act.
If the Respondent was to affirm the decision, the matter would return to the Tribunal pursuant to section 42D(8) and the proceeding resumes. If the decision is varied, and the variations are such that the Applicant remains unsatisfied with that circumstance, it returns to the Tribunal pursuant to the provisions of subsections 42D(3) and (4).
Counsel for the Respondent, Dr Renwick SC, indicated that the Minister does not intend to do anything that would announce to the world any conclusion other than this matter is subject to reconsideration pursuant to section 42D, through that process.
And if there were to be unwelcome restrictions on the product by way of a variation of the decision as a result of any reconsideration, the kind of restrictions that would appear to the Tribunal to be likely would be to those such as restrictions on point of sale; changes to the product information data; requirements to send ‘Dear Doctor’ letters; – all of which would be matters which would be for implementation in the hands of the Applicant, and the Applicant could return to the Tribunal immediately upon those circumstances.
So the Tribunal is minded to proceed as it tentatively indicated in its reasons, and to make the orders under the short minutes that have been handed up by counsel for the Respondent, and it will so order.
The only outstanding matter is that the Tribunal should give formal consideration to the question of the stay. As noted in paragraph 10 above, there is currently a stay in place pursuant to section 41(2) ‘until further order’. Both Dr Renwick SC and Mr Lloyd SC have accepted the Tribunal’s power to extend and keep in place the stay until further order exists, and the Tribunal shares that view. There are a series of cases, beginning with Yolbir v Administrative Appeals Tribunal (1994) 48 FCR 246; Civil Aviation Safety Authority v Hotop (2005) 145 FCR 232; and WorldAudio Limited v Australian Communications and Media Authority (2006) 194 FCR 462; all of which emphasise the breadth of the procedural power, to permit a stay to be granted so that the substantive issue can properly be determined by the Tribunal, and to ensure the parties are not disadvantaged through the effective loss of their entitlements before the substance of the application is finally determined.
The Tribunal takes the view that it remains seized of the substance of the application under section 42D, because of the terms of the provisions of subsections (3), (4) and (8).
Because neither counsel has taken a different view, the Tribunal does not need to give extensive reasons. Whilst these reasons are brief, they have been included to reflect the fact that it is a considered decision of the Tribunal that the existing stay remains in place.
Finally, the Tribunal drew counsels’ attention to changes the Tribunal proposed to make under the slip rule, section 43AA, in relation to paragraph 37 of its reasons of 15 June 2012. No objects to that course have been made, the Tribunal so directs.
I certify that the preceding 18 (eighteen) paragraphs are a true copy of the reasons for the decision herein of Justice Kerr, President and Dr Nicoletti, Member.
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Associate
21 June 2012
Date of resumed hearing 20 June 2012 Counsel for the Applicant Mr S Lloyd SC Solicitor for the Applicant
King & Wood Mallesons
Counsel for the Respondent
Dr J Renwick SC and Dr H Bennett
Solicitor for the Respondent Corrs Chambers Westgarth
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