Wyeth Australia Pty Ltd v Minister for Health & Aged Care

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 (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 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 (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)." 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.