Knoll Australia Pty Ltd and Minister for Health and Aged Care
[2000] AATA 926
•24 October 2000
DECISION AND REASONS FOR DECISION [2000] AATA 926
ADMINISTRATIVE APPEALS TRIBUNAL )
) No N00/365
GENERAL ADMINISTRATIVE DIVISION )
Re KNOLL AUSTRALIA PTY LIMITED
Applicant
And MINISTER FOR HEALTH AND AGED CARE
Respondent
DECISION
Tribunal Mr B.J. McMahon (Deputy President)
Date24 October 2000
PlaceSydney
Decision The application is dismissed.
(Sgd) BJ McMahon
..............................................
Deputy President
CATCHWORDS
HEALTH AND AGED CARE – application to Therapeutic Goods Administration for inclusion of sibutramine hydrochloride monohydrate in the Australian Register of Therapeutic Goods – application refused – remittal by delegate of the Minister – appeal to Administrative Appeals Tribunal – new information lodged in support of application for review - whether AAT has jurisdiction to review decision – no jurisdiction – application dismissed.
Administrative Appeals Tribunal Act 1975 – ss 25, 28
Therapeutic Goods Act 1989 – ss 4, 23, 25, 60, 60A
Collector of Customs (NSW) v Brian Lawlor Automotive Pty Limited (1979) 24 ALR 307
Edelsten v Health Insurance Commission (1990) 96 ALR 673
Hospital Benefit Fund of Western Australia Inc v Minister for Health, Housing and Community Services (1992) 111 ALR 1
Re Eli Lilly Australia Pty Limited and Minister for Health and Family Services (1999) 28 AAR 514
Trajkovski v Telstra Corporation Limited (1998) 153 ALR 248
Wyeth Australia Pty Limited v Minister for Health and Aged Care [2000] FCA 330
REASONS FOR DECISION
24 October 2000 Mr B.J. McMahon (Deputy President)
On 23 December 1997, the applicant applied to the Therapeutic Goods Administration (TGA) for inclusion of sibutramine hydrochloride monohydrate (Reductil) 10mg and 15mg capsules in the Australian Register of Therapeutic Goods pursuant to section 23 of the Therapeutic Goods Act 1989 (the Act). The applicant sought approval to register Reductil for the management of obesity including weight loss and maintenance of weight loss in conjunction with a reduced calorie diet.
The application was considered at the 205th meeting of the Australian Drug Evaluation Committee on 5 and 6 August 1999. By letter dated 13 August Dr Mitchell, as delegate of the Secretary, advised the applicant that he had decided to refuse the application for registration under section 25 of the Act. Pursuant to section 60, the applicant requested the Minister to reconsider Dr Mitchell's initial decision.
In response to this request, the applicant received a letter from a delegate of the Minister in the following terms:
"REJECTION OF SIBUTRAMINE HYDROCHLORIDE – YOUR REQUEST FOR REVIEW BY THE MINISTER
Thank you for your letters, dated 24th November 1999 and 9th December 1999, seeking review by the Minister of the decision ("the initial decision") made on 13th August 1999 by Dr Neil Mitchell, as delegate of the Secretary, to refuse the indication requested in your application of 23rd December 1997 for registration of Sibutramine hydrochloride monohydrate – Reductil on the Australian Register of Therapeutic Goods (ARTG) under the provisions of the Therapeutic Goods Act 1989.
I am the Minister's delegate for the purposes of this review.
Result of my reconsideration of the initial decision
I have decided to remit the matter to an authorised delegate for a fresh decision.
In making this decision I have reviewed the following evidence1. TGA Files 97/33588, 1999/023239 and 1999/039295 which contain correspondence between Knoll Australia and the TGA concerning sibutramine hydrochloride- Reductil between 8th December 1997 and 18th November 1999.
2. Three volumes of information supplied by Knoll Australia with appeal.
3. Information supplied by Knoll Australia in letter dated 9th December 1999.
4. Various volumes of original Submission by Knoll.
Reasons for my decision
On reviewing the information available to me I find that clinical trials SB5078, SB1048, SB2059X , and SB104 constitute New Information as defined in section 60A(8)(a) of the Act and may have influenced the Initial Decision had it been made available to the Delegate.
It is recommended that Knoll Australia supply all information in their possession, including finalised reports of studies for which interim reports have been supplied previously, which will allow a satisfactory review of sibutramine hydrochloride. Post market reports should also be submitted.
As this action is to be treated as if a fresh application for registration had been made, an additional evaluation fee calculated in accordance with item 4, of Schedule 9 of the Regulations is payable.
The Administrative Appeals Tribunal
Should you be dissatisfied with the result of your appeal then, subject to the Administrative Appeals Tribunal Act 1975, you may appeal to the Tribunal for review of the Minister's/Delegate's decision.
As part of any appeal you are entitled to a statement setting out the reasons for my decision (except where subsection 28(4) of the Administrative Appeals Tribunal Act 1975 applies).
I believe that the statement of reasons set out above complies with this requirement."
On 8 March 2000, the applicant lodged an application with this Tribunal for review of that decision. An objection was taken as to jurisdiction and a preliminary hearing was held to determine that threshold point. These reasons are concerned only with the question of this Tribunal's jurisdiction to review that decision.
The relevant objects of the Act are set out in section 4 as follows:
"Objects of the Act
(1) The objects of this Act are to do the following, so far as the Constitution permits:
(a)provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are:
(i) used in Australia, whether produced in Australia or elsewhere; or
(ii) exported from Australia;"
The applicant points to the fact that "timely availability" of therapeutic goods is given as much importance in paragraph (a) as their quality, safety and efficacy.
The jurisdiction to review decisions is set out in section 60 which is in the following terms:
"60 Review of Decisions
(1) In this section and section 60A
decision has the same meaning as in the Administrative Appeals Tribunal Act 1975.
Initial decision means a decision of the Secretary or of a delegate of the Secretary:(a)under the definition of therapeutic devices in subsection 3(1) or under subsection 7(1); or
(b) refusing to grant a consent under section 14; or
(c) under Part 3 or 4.
reviewable decision means a decision of the Minister under subsection (3).(2)A person whose interests are affected by an initial decision may, by notice in writing given to the Minister:
(a)in the case of a decision particulars of which are required to be notified in the Gazette – within 90 days after those particulars are notified; or
(b)in any other case – within 90 days after the decision first comes to the person's notice;
request the Minister to reconsider the decision.
(3)Subject to paragraph 60A(2)(b), the Minister must, as soon as practicable after receiving a request under subsection (2), reconsider the initial decision and, as a result of that reconsideration may:
(a) confirm the initial decision; or
(b)revoke the initial decision, or revoke that decision and make a decision in substitution for the initial decision.
(4)Where a person who has made a request under subsection (2) does not receive notice of the decision of the Minister on reconsideration, or (if applicable) notice that the matter has been remitted under paragraph 60A(2)(b), within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.
(5)After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, expect where subsection 28(4) of the Administrative Appeals Tribunal Act 1975 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Appeals for review of that decision.
(6)Where written notice of the making of an initial decision is given to a person whose interests are affected by the decision, the notice is to include a statement to the effect that a person whose interests are affected by the decision may:
(a) seek a reconsideration of the decision under this section; and
(b)subject to the Administrative Appeals Tribunal Act 1975, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Appeals Tribunal for review of that decision.
(7)Any failure to comply with the requirements of subsection (5) or (6) in relation to a decision does not affect the validity of the decision.
(8)An application may be made to the Administrative Appeals Tribunal for review of a reviewable decision."
Section 60A was inserted by section 82 of Act Number 6 of 1996 which came into effect on 11 June 1996. It deals with the procedures to be followed where "new information" is "lodged" either in support of an application to reconsider a primary decision or in support of an application to this Tribunal for review. The first situation is covered by subsections (1) and (2) as follows:
"60A New information on review – discretion to remit
(1)This section applies only if the Secretary or an authorised delegate makes a decision under section 25 in relation to therapeutic goods.
(2)If a person (the appellant) whose interests are affected by the decision requests the Minister to reconsider the decision, and lodges new information in support of that request, the Minister must either:
(a)take that information into account when he or she reconsiders the decision; or
(b) remit the matter to an authorised delegate for a fresh decision."
It will be seen that the Minister must either take the new information into account on reconsideration or must remit the matter to an authorised delegate for a fresh decision. If the Minister does neither within 60 days of the making of the request, then subsection 60(4) provides that he is to be taken to have confirmed the original decision. In that event, it would clearly be reviewable under subsection (3) by this Tribunal.
Subsections 60A(3)(4) and (5) set out the procedure to be followed by this Tribunal where new information is lodged with it in support of an application for review. The section then goes on to provide the procedure to be followed if either the Minister or the Tribunal remits the matter for a fresh decision in these terms:
"(6) If:
(a) the Minister or the Tribunal remits the matter; and(b)the appellant has paid, as a further evaluation fee, the evaluation fee that the appellant would have to pay under section 24 on making a new application for registration of the therapeutic goods;
the authorised delegate must make a decision under section 25, taking into account the new information, as if a fresh application for registration had been made.
(7) To remove any doubt, the authorised delegate's fresh decision is to be treated, for the purposes of subsequent applications of section 60 and this section as a decision under Part 3."
New information is defined in subsection (8) as follows:
"(8) In this section:
authorised delegate means a delegate of the Secretary exercising a power to decide whether to register therapeutic goods.
new information means information that:(a)was in existence at the time the decision referred to in subsection (1) was made; and
(b)was not made available to the Secretary or authorised delegate for the purpose of making the decision; and
(c)is relevant to that decision;
and includes any opinions that are wholly or substantially based on such information (whether or not the opinions were formed before or after the decision was made)."
I considered the meaning of this definition in Re Eli Lilly Australia Pty Limited and Minister for Health and Family Services (1999) 28 AAR 514 and pointed out (at 525) that the definition requires that all three elements be present before information can be classified as new information. If it was not in existence at the relevant time, or if it was made available to the Secretary, either formally or informally, or if it was not relevant to the section 25 decision, then it does not fall within the terms of the definition.
Finn J pointed to some of the difficulties in the application of this definition in Wyeth Australia Pty Limited v Minister for Health and Aged Care [2000] FCA 330. At paragraph 15 he referred to the "idiosyncratic" definition and concluded that "new information" is essentially "unused old information". He also referred to the difficulty (in paragraph 17) of prophesying what might be relevant to the decision actually taken. If any information falling within the first and second criteria is lodged, an applicant will need to make a value judgement as to whether it falls within the third criterion of relevancy in order to determine the procedure it should adopt.
In these circumstances, the respondent's principal submission was that the decision conveyed in the letter quoted above was made under subsection 60A(2) and was a decision to remit the matter for a fresh decision. The respondent relied upon subsection 60(3) which is referred to in the definition of "reviewable decision" to mean the only type of decision which this Tribunal may review.
The applicant has no knowledge of the basis upon which the delegate relied in reaching his conclusion that the four documents referred to in his letter constituted new information. In fact, it denies the accuracy of that conclusion. For example, it was said that two of the four study documents referred to by the delegate were not in fact "in existence" (as explained in Eli Lilly) at the relevant time and further that the Secretary was made aware of the other two study documents that were "in existence" . The respondent has, however, declined to give particulars of the basis for the delegate's decision to remit and insists that this Tribunal has no power to direct that such particulars be given.
It was submitted for the applicant that this Tribunal does have power to inquire into the basis upon which the delegate acted. Support for this was found in Trajkovski v Telstra Corporation Limited 153 ALR 248 at 256 and 257. In that case, Tamberlin J referred to the well-known Full Court decision in Collector of Customs (NSW) v Brian Lawlor Automotive Pty Limited (1979) 24 ALR 307 and the later decision of Hospital Benefit Fund of Western Australia Inc v Minister for Health, Housing and Community Services (1992) 111 ALR 1. There is no doubt that this Tribunal is entitled to review an invalid decision and is also entitled to determine whether it has appropriate jurisdiction. Referring to these cases, His Honour went on:
"The approach adopted in these cases lends support to the proposition that the AAT, in the present case, has the competence and authority to determine whether it has jurisdiction. It is not bound to decline jurisdiction simply because the jurisdictional question cannot be described as a "reviewable decision" and it must consider antecedent matters going to its jurisdiction in order to enable it to perform its primary function. See also Aronson and Dyer Judicial Review of Administrative Action, 1996 at 263 ff; A N Hall, "Judicial Power, The Duality of Functions and the Administrative Appeals Tribunal" (1994) 22 FL Rev 13 at 38 ff and J McMillan "Recent Themes in Judicial Review of Federal Executive Action" (1996) 24 FL Rev 347 at 382 ff.
Also, there is a line of English authority to the effect that, if a certain state of facts has to exist before a tribunal has jurisdiction, it can inquire into the facts in order to decide whether it has jurisdiction but it cannot give itself jurisdiction by wrong decision upon those facts. The courts may, by means of proceeding by way of prerogative writ such as certiorari, for example, inquire into the correctness of that decision. The AAT's decision as to the existence of state of facts is regarded as collateral because, although the exercise of jurisdiction depends on it, it is not the main question which the tribunal must determine: see R v Fulham, Hammersmith and Kensington Rent Tribunal; Ex parte Zerek [1951] 2 KB 1 at 6; R v Kensington and Chelsea (Royal) London Borough Rent Officer; Ex parte Noel [1978] QB 1 at 9; Wade, Administrative Law, 6th ed, 1988, pp 283-8; de Smith, Judicial Review of Administerial Action, 4th ed, 1980, at 110 ff."
In my view, the applicant cannot derive support from these cases and from the above passage. The present facts are not on all fours with those considered by His Honour. There is not here a question whether a subsection 60(3) decision was invalidly made. The question put by the applicant, rather, is whether the Minister's discretion is enlivened under subsection 60A(2). If, in fact, there was no "new information" then he would not have had power to remit the matter. Such a question is not, in my view, a reviewable decision. It may well be examinable under the Administrative Decisions (Judicial Review) Act. To determine whether the Minister has acted correctly, it may well be necessary to proceed in the Federal Court. The applicant submitted that such a course would be inconsistent with some of the observations made by Finn J in Wyeth and would be inconsistent with the legislative intent of Parliament.
It is true that Finn J referred (in paragraph 9) to a "tiered process of review leading ultimately to the Administrative Appeals Tribunal". It is true that the Act provides for internal and external review of section 25 decisions. It does not follow, however, that every decision under the Act falls within that tiered process. This Tribunal may review only those decisions in relation to which it has been given jurisdiction. Section 25(1) of the Administrative Appeals Tribunal Act restricts this Tribunal's powers of review to those conferred by enactments. If the only power of review granted by the Therapeutic Goods Act is a power to review decisions under subsection 60(3), that is to say decisions which confirm the initial decision or revoke the initial decision or revoke the initial decision and make a decision in substitution for that decision, then that is the only power of review which this Tribunal has.
It may mean that the applicant has no means available to it within the Act or within the Administrative Appeals Tribunal Act to challenge the basis of the decision to remit the matter. It does not follow, however, that this is necessarily an unintended effect of the legislation.
A decision to remit can be likened to a step along the way to a substantive decision. Such a decision resembles the intermediate non-reviewable step considered in Edelsten v Health Insurance Commission 96 ALR 673, rather than a final decision on the merits. The terms of the letter conveying the decision (notwithstanding the confused reference to this Tribunal in the last few paragraphs) indicate the temporary nature of the decision. On the face of the letter, there is no reconsideration on the merits. There is a refusal to reconsider part of the material put forward. There is an indication that if other material is supplied to the first level decision maker, then the process leading to approval may proceed. This may be awkward. It may be contrary to the stated objective of making new drugs available on a timely basis. It may prove ultimately to be unworkable. In Eli Lilly, I pointed out that the requirement to remit "the matter" meant that the processes of internal and external review were thereby re-started. Nevertheless, it seems to me that this is what must necessarily follow from the legislation.
It was submitted that if jurisdiction were denied in these circumstances, where an applicant relied on the Minister's interpretation of the relevant provisions and the relevant documents without challenge, then the result would be unjust, unreasonable and manifestly absurd. It does not seem to me that this is a necessary result. It certainly did not seem so to Finn J at paragraph 17 in Wyeth. Parliament appears to have given effect to a policy enunciated in the explanatory memorandum quoted at length by Finn J in paragraph 16. That sets out the reasoning behind (if not the reason for) the introduction of section 60A. It is to enable "new information" to be properly evaluated by experts before a decision on the merits is made. When that ultimate decision is made, then the power of external review arises. At that point, account may be taken of all matters bearing upon the merits of the application, including (subject to the terms of the Act) the "new information" which had been placed before the Minister with the request for reconsideration. In other words, an application to the Tribunal at this stage is premature.
The applicant is not left without a remedy. When all steps in the decision making process have been taken (whether they appear to be administratively cumbersome or not) then ultimately the applicant will have a right of review on the merits in this Tribunal. Until that time, this right has not arisen.
The Tribunal has no power to review the decision conveyed in the letter quoted above. The application is therefore dismissed.
I certify that the 23 preceding paragraphs are a true copy of the reasons for the decision herein of Mr B.J. McMahon (Deputy President)
Signed: .....................................................................................
Dominika Rajewski, AssociateDate of Hearing 17 October 2000
Date of Decision 24 October 2000
Counsel for the Applicant Mr Peter Dwyer
Solicitor for the Applicant Gadens Lawyers
Representative for the Respondent Mr Andras Markus
(Australian Government Solicitor)
0
3
0