Wyeth Australia Pty Ltd v Minister for Health & Aged Care [2000] FCA 330

FEDERAL COURT OF AUSTRALIA

PRACTICE AND PROCEDURE - application for an extension of time in which to apply for judicial review.

PRACTICE AND PROCEDURE - notice of motion seeking dismissal of the application if extension granted - whether the Therapeutic Goods Act makes adequate provision for review of the decisions under challenge.

ADMINISTRATIVE LAW - review of decisions rejecting an application to register a drug under the Therapeutic Goods Act 1989 (Cth).

Therapeutic Goods Act 1989 (Cth), s 3, s 4(1)(a), s 23, s 24, s 25, s 25(1)(d), s 25(3), s 31, s 31(1)(g), s 57, s 60, s 60(4), s 60A, s 60A(2), s 60A(3), s 60A(5), s 60A(6), s 63, s 63(2)(a)

Administrative Decisions (Judicial Review) Act 1977 (Cth), s 5, s 10, s 10(2)(b)(ii), s 11, s 11(1)(c)

Judiciary Act 1903 (Cth), s 39B

Therapeutic Goods Regulations 1990, Reg 36

Minister for Immigration and Multicultural Affairs v Ozmanian (1996) 71 FCR 1 referred

Kelly v Coats (1981) 35 ALR 93 referred

Hagedorn v Department of Social Security (1996) 44 ALD 274 referred

Edelsten v Minister for Health (1995) 58 FCR 419 followed

Darling Downs Bacon Co-operative Association Ltd v Comptroller-General of Customs (1994) 50 FCR 435 followed

R v Marks; Ex parte Australian Building Construction Employees and Builders Labourers' Federation (1981) 147 CLR 471 referred

Du Pont (Australia) v Comptroller-General of Customs (1993) 30 ALD 829 followed

R v Commonwealth Court of Conciliation and Arbitration; Ex parte Ozone Theatres (Aust) Ltd (1949) 78 CLR 389 followed

WYETH AUSTRALIA PTY LIMITED v MINISTER FOR HEALTH AND AGED CARE & ANOR

A 86 of 1999

FINN J

24 MARCH 2000

CANBERRA

IN THE FEDERAL COURT OF AUSTRALIA

AUSTRALIAN CAPITAL TERRITORY

DISTRICT REGISTRY

A 86 OF 1999

BETWEEN:	WYETH AUSTRALIA PTY LIMITED APPLICANT
AND:	MINISTER FOR HEALTH AND AGED CARE FIRST RESPONDENT ALEX PROUDFOOT SECOND RESPONDENT
JUDGE:	FINN J
DATE OF ORDER:	24 MARCH 2000
WHERE MADE:	CANBERRA

THE COURT ORDERS THAT:

1. leave to amend the application and to further amend the statement of claim be refused;

2. the time in which to lodge the application for an order of review be extended until the date of these orders;

3. the respondents' motion be allowed; and

4. the application be dismissed with costs.

Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA
AUSTRALIAN CAPITAL TERRITORY DISTRICT REGISTRY	A 86 OF 1999

BETWEEN:

WYETH AUSTRALIA PTY LIMITED

APPLICANT

AND:

MINISTER FOR HEALTH AND AGED CARE

FIRST RESPONDENT

ALEX PROUDFOOT

SECOND RESPONDENT

JUDGE:	FINN J
DATE:	24 MARCH 2000
PLACE:	CANBERRA

REASONS FOR JUDGMENT

1 The present proceeding involves in no little measure an attempt to avert the need to pay again a not insubstantial fee to have a drug evaluated for registration under the Therapeutic Goods Act 1989 (Cth) ("the TG Act"). The applicant, Wyeth Australia Pty Ltd ("Wyeth"), has been unsuccessful in obtaining a decision favourable to its application to have its particular drug (PNU-IMUNE 23) registered, either from the delegate of the Secretary of the Department of Health and Aged Care, or from the Minister for Health and Aged Care (by his delegate Mr Proudfoot) on review of the Secretary's delegate's decision. Mr Proudfoot and the Minister are the second and first respondents respectively.

2 Wyeth's lack of success led in the first instance to its lodging an appeal to the Administrative Appeals Tribunal ("the Tribunal") against the Minister's decision - an appeal provided for in s 60 of the TG Act. Subsequently Wyeth initiated the present application for the purposes (a) of obtaining an extension of time under s 11 of the Administrative Decisions (Judicial Review) Act 1977 (Cth) ("the ADJR Act") in which to lodge an application for an order of review under that Act; and (b) of securing review of the Minister's decision under s 39B of the Judiciary Act 1903 (Cth).

3 The respondents not only oppose the grant of leave for ADJR Act purposes, they have filed a motion that the application be dismissed. For ADJR Act purposes they rely upon s 10(2)(b)(ii) on the basis that the TG Act itself makes adequate provision for the review of the decision in question. The extension of time application and the motion to dismiss are the two matters that have been agitated before me.

The Statutory Setting

1. The TG Act

4 It is necessary to outline the scheme of the TG Act and its Regulations at some length.

5 The Act provides a scheme for the registration of "therapeutic goods" - a term defined in s 3 of the Act. An object of the Act is to 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 … used in Australia": s 4(1)(a). The wholesale supply of such goods without registration is, save in designated circumstances, an offence. Part 3, Division 2 of the Act prescribes the processes, etc that can lead to registration. They involve (i) the making of an application in the form, and subject to the conditions, prescribed: s 23; (ii) the payment of a specified fee in respect of the evaluation of the goods for registration: s 24 - in the instant case that fee was in excess of $85,000; and (iii) the evaluation and registration of the goods.

6 Section 25 of the Act prescribes the last of the above. It provides, insofar as presently relevant:

"25 (1) Where:

(a) an application is made for the registration of therapeutic goods in relation to a person in accordance with section 23;

…

the goods are to be evaluated for registration having regard to:

(d) whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established; and

…

(k) such other matters (if any) as the Secretary considers relevant.

…

(3) After therapeutic goods have been evaluated for registration, the Secretary must:

(a) notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and

(b) if the decision is to register the goods - include the goods in the Register and give the applicant a certificate of registration."

7 I would interpolate that the "Secretary" referred to is the Secretary of the Department of Health and Aged Care and that, as will be indicated below, a means of evaluating goods for subsection (1)(d) purposes is provided in the Regulations to the Act.

8 Section 31 of the Act empowers the Secretary to require an applicant for registration to provide information or documents relating (inter alia) to the safety and efficacy of the goods in question for the purposes to which they are to be used: s 31(1)(g). I would also note in passing that s 57 of the Act enables both the Minister and the Secretary to delegate to specified officers "all or any of his or her powers and functions under this Act". This power was employed in the present matter by both the Minister and the Secretary.

9 The Act establishes a tiered process of review leading ultimately to the Administrative Appeals Tribunal. The first tier of review is to the Minister (or a delegate) from the decision of the Secretary (or a delegate). The Minister's (or delegate's) decision in turn is reviewable by the Tribunal: the Act, s 60. The Act makes express provision for how "new information" - a term with its own somewhat unusual definition - is to be dealt with if brought forward in either of the review phases: s 60A.

10 Because of their centrality to this matter the provisions of s 60 and s 60A need to be set out at length. Section 60, for present purposes, provides:

"60 Review of decisions

(1) In this section and section 60A:

decisionhas the same meaning as in the Administrative Appeals Tribunal Act 1975.

initial decisionmeans 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

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 so 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, except 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 Tribunal for review of that decision.

…

(8) An application may be made to the Administrative Appeals Tribunal for review of a reviewable decision.

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.

(3) If the appellant applies to the Administrative Appeals Tribunal for review of the decision on reconsideration, and lodges new information in support of that application, the Tribunal may, if the Tribunal thinks fit, remit the matter to an authorised delegate for a fresh decision.

(4) The Tribunal must not remit the matter under subsection (3) if all of the new information is information that the Minister took into account under paragraph (2)(a) in making the decision on reconsideration.

(5) If:

(a) the appellant lodges new information in support of an application to the Administrative Appeals Tribunal for review of the decision on reconsideration; and

(b) the Tribunal does not remit the matter under subsection (3);

the Tribunal, in reviewing the decision on reconsideration:

(c) may consider new information (if any) that the Minister took into account under paragraph (2)(a) in making the decision on reconsideration; and

(d) must not consider any other new information, except new information that indicates that the quality, safety or efficacy of the therapeutic goods is unacceptable.

(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.

(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

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)."

11 It will be necessary to comment below in some detail on s 60A. For present purposes I would note that it was introduced into the TG Act in 1996 along with requisite amendments to s 60.

12 The regulation-making power of the Act (s 63) authorises regulations that make provision (inter alia) for:

"(i) the establishment of committees to advise the Minister or the Secretary on matters relating to therapeutic goods; and

(ii) the functions and powers of those committees; and

(iii) the payment of remuneration and allowances to members of those committees": [s 63(2)(a)].

A committee established under this power is the Australian Drug Evaluation Committee ("ADEC") the functions and membership of which are prescribed in Reg 36 as follows:

"(2) The functions of the Committee are:

(a) to make medical and scientific evaluations of any medicines that the Minister or the Secretary refers to it for evaluation; and

(b) to make medical and scientific evaluations of other medicines if, in the opinion of the Committee, it is desirable that it should do so; and

(c) to make medical and scientific evaluations of such therapeutic devices that the Minister or the Secretary refers to it for evaluation; and

(d) to give advice to the Minister or the Secretary about the importation into, the exportation from and the manufacture and distribution within, Australia of therapeutic goods that have been the subject of evaluation by the Committee; and

(e) to give advice that has been given to the Minister or the Secretary under paragraph (d) to persons or bodies as the Minister may direct.

(3) Membership of the Committee consists of:

(a) 6 or 7 core members; and

(b) at least 10, and not more than 20, associate members.

(4) The Minister must appoint to the Committee:

(a) as core members:

(i) at least 3 persons, each of whom is a medical practitioner eminent in the medical profession and at least 2 of whom are specialists in clinical medicine; and

(ii) at least 1 person who is a pharmacologist, or who holds a university degree in science or a branch of science and has specialised in pharmaceutical science; and

(b) as associate members:

(i) at least 1 person who is a pharmaceutical chemist with recent experience in the manufacturing of therapeutic goods; and

(ii) at least 1 person who is a toxicologist; and

(iii) at least 1 person who is a medical practitioner currently engaged in general practice; and

(iv) other persons, each of whom:

(A) satisfies a criterion set out in subparagraph (i), (ii) or (iii); or

(B) is a medical practitioner with specialist qualifications and experience in a field of medicine that complements the expertise of core members with medical qualifications."

I emphasise the composition of ADEC given the legislative policy of s 60A to which I will refer.

13 While the statutory scheme of the Act does not directly prescribe that medical and scientific evaluations under s 25 of the Act must be made by ADEC of therapeutic goods for which registration is sought, ADEC did undertake such an evaluation of the applicant's drug in the present case.

2. A Comment on s 60A

14 When enacted, s 60 of the TG Act enshrined the same tiered review system leading to the Tribunal that remains in the Act in its present amended form. The 1996 amendment in introducing s 60A (to which the s 60 review procedures were then made subject) was designed to tighten the appeal provisions. As the second reading speech indicated:

"This [tightening] will ensure that technical and scientific data that should be lodged in connection with a general marketing application will be evaluated before a review on merits is undertaken by the Administrative Appeals Tribunal."

15 The rather idiosyncratic definition of "new information" in s 60A encapsulates the legislative design: "new information" is information that was in existence at the time of, and was relevant to, the Secretary's (or delegate's) decision, but was not made available to the Secretary (or delegate) for the purpose of making the decision. In other words "new information" is essentially unused "old information". If such information is to be used in the appeal/review processes of s 60, this must be in accordance with s 60A.

16 Because of the importance of this new section to the present application, it is appropriate to set out at length the terms of the relevant sections of the Explanatory Memorandum to the 1996 amendment as it encapsulates the purpose and the policy of the provision.

"New section 60A qualifies the way in which appeals against decisions made under section 25 of the Act are to be dealt with. Under section 25 registrable therapeutic goods must undergo rigorous scrutiny for the purposes of establishing whether they may be approved for general marketing. The decision to approve rests with the Secretary, following a long process of evaluation involving expert advice drawn from numerous disciplines including a specialist committee set up under the Therapeutic Goods Regulations to make recommendations concerning this matter.

New section 60A applies to circumstances where the Secretary makes a decision under section 25 and an aggrieved party affected by the decision lodges an appeal together with new information to support that appeal, with the Minister under section 60 of the Act. The Minister must, for the purposes of review, either take into account any new material lodged by the applicant for review where the Minister or his delegate is capable of processing that material, or else remit the matter to a person who has been delegated powers to make decisions under section 25 of the Act, so that the new information may be properly evaluated by relevant experts. "New material", in relation to the product the subject of a review, refers to relevant information that came into existence before a decision was made under section 25 of the Act and that had not been evaluated under that section by the Secretary. Where new material is presented before the Administrative Appeals Tribunal ("the Tribunal") on appeal from the Minister's decision under this section, the Tribunal is precluded from considering any new material unless this was taken into account by the Minister under subsection 60A(2). Where the Tribunal is precluded from considering the new material, it may remit the new material to a person who has been delegated powers to make decisions under section 25 of the Act.

Where the Minister or the Tribunal remits to a person who has been delegated powers to make decisions under section 25 of the Act new material for reconsideration, the delegate must make a decision pursuant to that provision as though the applicant had made a fresh application, providing the applicant has paid the appropriate evaluation fees that an applicant under section 24 of the Act would have been required to pay. The decision of a delegate under this section is reviewable under sections 60 and 60A of the Act.

The effect of this amendment is to encourage sponsors applying for general marketing of therapeutic goods to lodge all relevant material with the Secretary so that the vigorous evaluation process employed in processing the product may be conducted properly in respect of all material sought to be relied upon by the applicant, and that when review of a decision is undertaken by the Administrative Appeals Tribunal any technical and scientific data not previously evaluated by the Secretary would first undergo proper evaluation before the matter is considered by the Tribunal and a decision on merits is made."

17 The legislative scheme then is clear enough - even though it may require some foresight, if not power of prophecy, on an applicant's part as to what may be "relevant" to the decision actually taken. Information available at the time of the decision is to be subjected to proper evaluation before the Secretary's (or delegate's) decision. If it is brought forward in the appeal/review process, and if it is to be used, the whole matter will be likely to be (s 60A(2), (3), (5)) remitted back to a delegate of the Secretary for decision. And such a delegate's decision under s 25 is to be made after, and "on", the s 25(1)(d) evaluation of the goods in question: s 25(3).

3. The ADJR Act

18 Section 10 of this Act provides, insofar as presently relevant, that:

"10 (1) The rights conferred by sections 5, 6 and 7 on a person to make an application to the Court in respect of a decision, in respect of conduct engaged in for the purpose of making a decision or in respect of a failure to make a decision:

(a) are in addition to, and not in derogation of, any other rights that the person has to seek a review, whether by the Court, by another court, or by another tribunal, authority or person, of that decision, conduct or failure; and

…

(2) Notwithstanding subsection (1):

…

(b) the Court may, in its discretion, refuse to grant an application under section 5, 6 or 7 that was made to the Court in respect of a decision, in respect of conduct engaged in for the purpose of making a decision, or in respect of a failure to make a decision, for the reason:

(i) that the applicant has sought a review by the Court, or by another court, of that decision, conduct or failure otherwise than under this Act; or

(ii) that adequate provision is made by any law other than this Act under which the applicant is entitled to seek a review by the Court, by another court, or by another tribunal, authority or person, of that decision, conduct or failure.

(3) In this section, "review" includes a review by way of reconsideration, re-hearing, appeal, the grant of an injunction or of a prerogative or statutory writ or the making of a declaratory or other order."

The Factual Setting

19 Wyeth's drug, PNU-IMUNE 23, is a vaccine for active immunisation to prevent pneumococcal bacterial diseases caused by the 23 pneumococcal types in the vaccine including pneumonia and meningitis. It has, since its registration in the United States in 1983, been registered in many European countries including most recently the UK and Switzerland in 1997.

20 On 2 December 1997 Wyeth applied under s 23 of the TG Act for the registration of its drug. Its application was accompanied by supporting material. It paid a prescribed fee (in excess of $85,000) and between February and October 1998 it provided further information to the Department in response to requests and questions. A clinical evaluation report of Wyeth's clinical data was provided to the Department in October 1998. A copy was given to Wyeth in November. That report recommended that the drug should be approved but noted that the Department should obtain a report from vaccine surveillance authorities where the vaccine had been in use for a number of years and particularly from the United States. A like pre-clinical evaluation report on Wyeth's data was prepared in the Department in November 1998. A copy was sent to Wyeth. This report advised there were no pre-clinical issues to preclude registration of the drug.

21 In December 1998 the Secretary's delegate prepared a summary that indicated that the delegate proposed to register Wyeth's drug but referred the matter to ADEC for advice. The summary itself raised issues concerning both "immunogenicity" - which is a surrogate measure of vaccine efficacy where efficacy trials are not practical - and safety. It stated:

"In summary, the data on immunogenicity include numerous instances where the response to a particular serotype antigen failed to meet both FDA criteria. On balance, however, there is probably sufficient evidence across studies of adequate immunogenicity particularly when judged by the fold increase in GMT.

Safety

The safety data are patchy. The sponsor should provide, no later than the Pre-ADEC response, available data about adverse reactions to Pnu-Imune 23 held by the US Vaccine Adverse Event Reporting Scheme. If the data are voluminous, a brief summary should be provided with the Pre ADEC response and the more extensive data submitted to TGA no later than the Pre ADEC cut-off.

I agree with the evaluator that the evidence of acceptable safety of Pnu-Imune 23 is adequate."

22 Wyeth was invited by the delegate to provide comments on the evaluation that had been made of its data and of the delegate's proposed action. Those comments were to be provided by 11 January 1999. They were provided on 8 January 1999 but without the data from the US Vaccine Adverse Event Reporting Scheme. I would interpolate that it is Wyeth's case that it would have taken a minimum of 6 months to submit that data and that the respondents should have known this.

23 The members of ADEC who met on 4-5 February 1999 resolved to recommend to the delegate that Wyeth's application be rejected. Resolution No 7601 recorded:

"The application by Wyeth Australia Pty Limited to register PNU-IMUNE 23 Pneumococcal Vaccine for active immunisation against pneumococcal disease casued by the twenty-three pneumococcal types included in the vaccine, should be rejected on the grounds of inadequate evidence of immunogenicity and safety."

24 A copy of the resolution was provided to the Secretary's delegate who on 12 February 1999 decided to reject Wyeth's application for the reasons given in ADEC's resolution. This decision was not challenged as such in the original application but was the subject of an amendment to which I will later refer.

25 It is one of Wyeth's complaints that it was not provided with the ADEC resolution or allowed the opportunity to be heard on it prior to it being relied upon by the delegate.

26 In March of 1999 ADEC provided Wyeth with an unratified copy of the minutes of its meeting giving rise to the adverse resolution. A ratified copy was provided on 30 April.

27 On 7 May 1999 Wyeth appealed to the Minister for review of the decision of the Secretary's delegate under s 60 of the TG Act. Wyeth's appeal statement included (inter alia) a summary of adverse events reported to Wyeth (US) in the period 1980-1988 for the drug and additional post-marketing safety data covering a 15 year period.

28 The Minister's delegate, Mr Proudfoot, raised as a preliminary matter with Wyeth whether the information referred to above constituted "new information" under s 60A. In a letter to Wyeth of 25 May 1999 he indicated:

"As you know, if 'new information' is submitted with an appeal, I have discretion under s 60A(2) of the Act to remit the matter to an authorised delegate of the Secretary. I do not consider it appropriate to make a decision on whether I would exercise that discretion before you decide whether or not to withdraw the data."

Wyeth withdrew the data.

29 On 1 June 1999 Mr Proudfoot confirmed the initial decision of the Secretary's delegate though the grounds for his decision were limited to the efficacy of the product not being satisfactorily established. His reasons for decision are contained in a letter to Wyeth of 1 June. Their operative parts for present purposes state:

"Result of my reconsideration of the initial decision

I have decided to confirm the initial decision.

Findings of fact

My findings on material questions of fact, and the evidence on which these findings are based, are given below.

(1) On 2 December 1997 your company applied for registration of Pnu-Imune 23 vaccine ("the product") under the Therapeutic Goods Act 1989 ("the Act"), and submitted a package of data in support of the application.

Evidence:

Documents on file

(2) Expert advice was sought from the Australian Drug Evaluation Committee (ADEC). At its meeting on 4-5 February 1999, ADEC gave the following advice:

RESOLUTION NO 7601

THE APPLICATION BY WYETH AUSTRALIA PTY LTD TO REGISTER PNU-IMUNE 23 PNEUMOCOCCAL VACCINE FOR ACTIVE IMMUNISATION AGAINST PNEUMOCOCCAL DISEASE CAUSED BY THE TWENTY-THREE PNEUMOCOCCAL TYPES INCLUDED IN THE VACCINE, SHOULD BE REJECTED ON THE GROUNDS OF INADEQUATE EVIDENCE OF IMMUNOGENICITY AND SAFETY.

Evidence:

Ratified minutes of ADEC's meeting of 4-5 February 1999.

(3) The efficacy of the product has not been satisfactorily established.

Evidence:

I have accepted the ADEC's expert advice on this - in particular, its advice that evidence of immunogenicity is inadequate.

Wyeth has acknowledged (main appeal document, section 2) problems with the data submitted: limited number of studies; small numbers of subjects; most studies reported immune responses towards a small number of the 23 antigens; most studies in healthy individuals were conducted many years ago. However, Wyeth's position is that these factors are not sufficient to warrant rejection of the product in the context of immunogenicity in relation to pneumococcal vaccines generally. This is a matter for expert assessment, and I consider ADEC, with its broad range of expertise and practical experience, is well placed to undertake such an assessment.

Reasons for my decision

In view of fact (3) above, the product should not be registered, under s 25(1)(d) of the Act.

The Administrative Appeals Tribunal

Except where subsection 28(4) of the Administrative Appeals Tribunal Act 1975 applies, you may apply for a statement setting out the reasons for my decision. Subject to that Act, you may make application to the Administrative Appeals Tribunal for review of my decision.

In view of the statement of reasons set out above, I believe subsection 28(4) of the Administrative Appeals Tribunal Act 1975 applies."

30 It was this decision that Wyeth sought to challenge in its projected ADJR Act proceedings though, as noted, it has sought to amend its application.

31 On 23 June 1999 Wyeth applied to the Tribunal for review of Mr Proudfoot's decision. It alleged that the decision was against the weight of evidence, and that there were errors of law (unspecified). The parties filed Statements of Issues with the Tribunal, the Minister indicating that safety as well as immunogenicity were to be in contest. By late August Wyeth was foreshadowing an application for a "proper statement of reasons" from Mr Proudfoot. Solicitors for the Minister by letter of 20 August not only did not accept the asserted inadequacy of the reasons but indicated little likelihood of the matter being resolved inter partes.

32 A Mr Toy, a senior associate in the firm of solicitors representing Wyeth, has deposed that from that time he commenced working on the preparation of an application to this Court. It apparently took about 8 weeks to prepare the statement of claim accompanying the application, the present application being filed on 22 October 1999. Mr Toy has pointed to difficulty with the documentation as a cause of the delays in preparing the statement of claim. I comment below on the statement of claim.

33 On 15 September 1999 the Tribunal indicated to Wyeth's solicitors that, as it had been informed apparently of the proposed Federal Court application, it did not propose to fix any directions hearing until the outcome of that application was known.

34 Mr Peter Grant, a manager of Wyeth, has deposed that the reasons why Wyeth now seeks ADJR Act review rather than review by the Tribunal are:

(i) the restriction s 60A of the TG Act places on merits review by the Tribunal;

(ii) the lack of proper reasons for decision;

(iii) the fact that the first respondent is fully contesting the matter without attempting to resolve it; and

(iv) this Court's resolution would be more economical and timely.

The s 60A restriction on considering "new information" is highlighted as well in Mr Toy's affidavit, it being Wyeth's intent apparently to rely on the data submitted to Mr Proudfoot but then later withdrawn, as also, possibly, data held by the US Vaccine Adverse Event Reporting Scheme.

The Originally Proposed ADJR Act/s 39B application

35 Wyeth's application is to review the decision of the respondents. Its statement of claim is, though, much preoccupied with conduct and particularly that of ADEC in making its recommendation to the Secretary's delegate. This asymmetry between the application and the statement of claim was one of the reasons for Wyeth's application for leave to amend the application, etc referred to below.

36 The grounds advanced in the statement of claim relate to:

(i) the alleged delegation in effect by Mr Proudfoot to ADEC of the decision it was his duty to make, this "delegation" giving rise to a number of complaints under s 5 of the ADJR Act;

(ii) an alleged breach of natural justice by Mr Proudfoot in not providing Wyeth with adequate reasons for ADEC's recommendation prior to his decision;

(iii) ADEC's recommendation itself, this being challenged as conduct engaged in for the purpose of making Mr Proudfoot's decision, the vices in it being allegedly (a) unreasonableness, (b) a breach of natural justice, (c) reliance on a nonexistent fact, (d) failure to take relevant considerations into account, (e) error of law and (f) taking irrelevant consideration into account; and

(iv) conduct of Mr Proudfoot being (1) unreasonableness (a) in the time given Wyeth to provide the adverse event information to ADEC, and (b) in the proposal to remit the matter if Wyeth did not withdraw the new information provided to him; and (2) a breach of the rules of natural justice because of conduct prior to the decision of the Secretary's delegate.

37 There were real questions as to whether much of the above was relevant to the judicial review application. This, as I have indicated, challenged only the decision of the Minister and Mr Proudfoot. Significantly, notwithstanding that ADEC's recommendation (on which so much appears to hinge) was made prior to the decision of the Secretary's delegate, that decision was not impugned. It was the subject of a late amendment application as I will indicate.

The Proposed Amendments

38 During and at the end of the hearing the applicant sought leave, variously, to amend the application and statement of claim to review the respondents' conduct and to join the Secretary's delegate as a party. A consequential extension of time was sought in relation to these amendments and for service of the proceedings on the proposed third respondent. The alleged need for the joinder of the Secretary's delegate is that any order made in the proceedings as presently constituted may be rendered futile by the possible operation of s 60(4) or s 60A(2) of the TG Act unless the Secretary's delegate's decision as well is set aside: see below. The amendments of the statement of claim are, it is said, designed to bring ADEC's, as also the Secretary's delegate's, conduct directly into issue though without raising any significantly new material facts.

39 The amendments and joinder sought are not insignificant. That the Secretary's delegate's decision was not impugned in the original application was adverted to explicitly in the respondents' defence. Yet now the applicant seeks to add in effect a new action against the delegate in respect of his decision and of conduct leading to it. These amendments, moreover, were only foreshadowed as a possibility after the respondents' counsel had addressed the motion to dismiss and were foreshadowed only for the purpose of resolving a possible difficulty in relation to remedy if the decisions of the first and second respondents were set aside. In other words the amendments themselves were premised on the contingency of the applicant obtaining relief on the statement of claim as it stands without the proposed amendment. As counsel for the applicant conceded, the amendment to the application would not make any difference if the motion to dismiss was successful.

40 Given the lateness of the amendments and joinders sought, their contingent character, and their raising (albeit at an earlier stage in the appeal/review process of the TG Act) an apparently like s 10(2)(b)(ii) issue to that presently raised, I am not prepared to grant the leave sought. As with Mr Erskine, the applicant's counsel, I do not consider that the amendments would make any difference if the respondents' motion to have the (unamended) application dismissed was successful. Yet to allow the amendments would require, potentially, significant new material to be put on in the applicant's application for extensions of time - a need foreshadowed by the respondents in written submissions. To the extent that they seek to have both ADJR Act s 5 "decisions" and s 6 "conduct" reviewed they are potentially problematic in any event: Minister for Immigration and Multicultural Affairs v Ozmanian (1996) 71 FCR 1 at 18-23.

The Respondents' Motion

41 Because of the view I take of it, I will consider the respondents' motion first and on the assumption that an extension of time will be granted.

42 The respondents accept that the onus is on them to persuade the court that (i) it should not exercise its ADJR Act jurisdiction: Kelly v Coats (1981) 35 ALR 93 at 94; Hagedorn v Department of Social Security (1996) 44 ALD 274 at 281; and (ii) for the purposes of its s 10(2)(b)(ii) motion, all facts in support of the applicant's claim must be assumed in the applicant's favour - an assumption that will usually result in the conclusion that an applicant will be able to make out its claim: Edelsten v Minister for Health (1995) 58 FCR 419 at 421-422. Nonetheless they contend that the legislative scheme of the TG Act is such not only that adequate provision is made to review the Minister's decision, but also that in the detail of the Act's review structure - and in particular in its s 60A scheme for handling "new information" - there is a manifest legislative purpose and policy that the TG Act review provisions be followed: Edelsten's case, at 423-425; Darling Downs Bacon Co-operative Association Ltd v Comptroller-General of Customs (1994) 50 FCR 435 at 442. Even assuming judicially reviewable errors had occurred in the respondents' decisions and in the conduct engaged in for the purposes of those decisions, the Tribunal in its review would not only be unaffected by those errors, it could also consider all of the issues afresh thus curing any previous error or unfairness and in particular any prior breach of natural justice (which is itself denied): cf R v Marks; Ex parte Australian Building Construction Employees Builders and Labourers' Federation (1981) 147 CLR 471 at 485. It is submitted there is no hardship to Wyeth inherent in its being obliged to go to the Tribunal: Du Pont (Australia) v Comptroller-General of Customs (1993) 30 ALD 829 at 832. If it does not introduce "new information" it will enjoy a full merits review and a decision which (unless itself giving rise to a question of law) that will be unreviewable by this court and will be "completely binding on the parties": Edelsten's case, at 424-425. If Wyeth does introduce "new information" then that information will be likely to have to be evaluated - as the legislature in s 60A clearly envisaged it must, if it is to be used.

43 The applicant's contention is that the form of Tribunal review envisaged by the TG Act is not "adequate" for s 10(2)(b)(ii) purposes. The reason for this is that, because of restrictions imposed by s 60A the Tribunal cannot make its own decision on all the merits. In consequence because the Tribunal cannot substantively consider new information - and the introduction of such has been foreshadowed as I have indicated in the earlier factual narrative - the "maximum result obtainable" by the applicant before the Tribunal would be for the Tribunal to remit the matter under s 60A to an authorised delegate for a fresh decision and the applicant would have to convince the Tribunal to make that decision. This in turn, it is asserted, would be a long and costly process. Additionally the applicant asserts that Mr Proudfoot's failure to supply proper reasons for decision makes merits review impractical.

44 I would have to say I am in substantial agreement with the respondents' submissions in this matter. There is a clearly adequate and appropriate review process established by the TG Act - and a process, moreover, which the legislature has deliberately contrived via s 60A so as to produce particular outcomes whenever an applicant seeks (as here) to introduce "new information" in the review process. It is, in my view, no proper cause for complaint to point to the restriction s 60A imposes on merits review by the Tribunal. Parliament, for its own good and proper reason as the Explanatory Memorandum indicated, intended that restriction. The effect of the present judicial review application is simply to attempt to subvert the purpose of the legislation in its treatment of new information. Even if the judicial review proceedings were permitted and were successful, and the Minister's and Mr Proudfoot's decisions were set aside, the same practical result would in all likelihood ensue as if the Tribunal were to remit the matter under s 60A. If the effect of the judicial review proceedings was that the Minister's decision was set aside, and the Minister was required to consider the matter anew (but cf s 60(4) referred to below) the likelihood is, as the Explanatory Memorandum makes plain, that the matter would be remitted to an authorised delegate for a fresh decision. I would make an additional comment (on the assumption I had allowed joinder of the Secretary's delegate). If both the Minister's and the Secretary's delegate's decisions were to be set aside the same result would ensue - albeit without the need to pay a new evaluation fee under s 60A(6). I would add, though, that there would be a real question in any event whether, in judicial review proceedings, the Court could or would set aside the earlier decision of the Secretary's delegate after an appeal to the Minister had occurred because of the latter's corresponding capacity to cure preceding errors, etc and, subject to s 60A, to take new information into account. Even if the need now to advance new information arose because of an earlier denial of natural justice - and this is controversial on the facts given the circumstances of the Minister's reconsideration of the decision of the Secretary's delegate on ADEC's advice - that information would, if it was to be used, require evaluation. In the circumstances the Act prescribes how such could occur. I see no reason why there should be resort to judicial review proceedings to secure what the Act itself accommodates.

45 None of the actual grounds of judicial review raised by Wyeth are of such character, or so put into contention the meaning of the provisions of the TG Act, as would warrant as a discretionary matter the dismissal of the motion. Equally I do not consider that any case of hardship to Wyeth is apparent on the material before me. It cannot characterise as hardship either the Tribunal's need to comply with the explicit requirements of the TG Act or the consequences to Wyeth that inhere in the scheme of the legislation should it choose to advance new information in the review process.

46 Distinctly, I consider the attack on Mr Proudfoot's reasons as being of little moment. Those reasons may be economical. But the Tribunal hearing is one on the merits. The parties know the issues to be agitated before the Tribunal. It is for the Tribunal to make its own decision on the material before it.

47 In relation to the claim for relief under s 39B of the Judiciary Act 1903, as I consider "a more convenient and satisfactory remedy exists" as I have already indicated, I would in the circumstances refuse the relief sought as a matter of discretion: R v Commonwealth Court of Conciliation and Arbitration; Ex parte Ozone Theatres (Aust) Ltd (1949) 78 CLR 389 at 400; Du Pont (Aust),above, at 832.

48 I would allow the motion and dismiss the application. There is one final matter, though, to which I should refer but on which I need not express any concluded view. The respondents have submitted that the provisions of s 60(4) of the Act (that deem the Minister to have confirmed the original decision after 60 days unless notice of the Minister's decision has been received by the applicant) would in any event render judicial review proceedings futile. If the Minister's decision was set aside, the deeming effect of s 60(4) would in the circumstances itself effect a confirmation of the Secretary's delegate's decision. I refrain from expressing any view on the correctness or otherwise of this submission, though I would note that it provides a reason for Wyeth's amendment of the application to have the Secretary's delegate joined as a party for the purpose of having his decision set aside.

The Application to Extend Time

49 Given the view I have taken on the motion to dismiss, I will extend time in which to lodge the application for judicial review under s 11(1)(c) of the ADJR Act for the purpose of dismissing the application under s 10(2)(b)(ii). I am far from satisfied that the merits of the application for an extension of time are strong in any event. It is not necessary for me in the circumstances to evaluate it in its own right.

Conclusion

50 I refuse leave to amend the application and to further amend the statement of claim; I extend the time in which to lodge the application for an order of review until the date of these orders; I allow the respondents' motion and dismiss the application with costs.

I certify that the preceding fifty (50) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Finn.

Associate:

Dated: 23 March 2000

Counsel for the Applicant:	Mr C Erskine

Solicitor for the Applicant:	Dunhill Madden Butler

Counsel for the Respondents:	Mr S Lloyd

Solicitor for the Respondents:	Australian Government Solicitor

Date of Hearing:	13 March 2000

Date of Judgment:	24 March 2000

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