SmithKline Beecham (Australia) Pty Ltd v Chipman

the relevant legislation 9 Section 25 of the Act makes provision for therapeutic goods to be registered in the ARTG. That section relevantly provides: "25 Evaluation and registration of therapeutic goods (1) Where: (a) an application is made for the registration of therapeutic goods in relation to a person in accordance with section 23; and (b) there is no part of an evaluation fee under section 24 in respect of those goods that: (i) is due and payable by the person; and (ii) remains unpaid; and (c) the person has complied with any requirements made by the Secretary under section 31 in relation to the goods; 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 (e) whether the presentation of the goods is acceptable; and (f) whether the goods conform to any standard applicable to the goods, or any requirements relating to advertising applicable under the regulations; and (g) if a step in the manufacture of the goods has been carried out outside Australia - whether the manufacturing and quality control procedures used in the manufacture of the goods are acceptable; and (h) if the goods have been manufactured in Australia - whether the goods have been manufactured in accordance with Part 4; and (j) whether the goods contain substances that are prohibited imports for the purposes of the Customs Act 1901; and (k) such other matters (if any) as the Secretary considers relevant. (2) In making a decision for the purposes of paragraph (1)(g), the matters that may be taken into account include: (a) whether the applicant has provided: (i) if the goods are not therapeutic devices and a step in the manufacture of the goods has been carried out in a country that is a member of the European Community or a member of EFTA - a conformity assessment certificate in relation to the goods; or (ii) in any other case - an acceptable form of evidence from a relevant overseas authority establishing that the manufacture of the goods is of an acceptable standard; and (b) whether the applicant has agreed to provide, where the Secretary considers inspection of the manufacturing procedures used in the manufacture of the goods to be necessary: (i) funds for the carrying out of that inspection by the Department; and (ii) evidence that the manufacturer has agreed to such an inspection. … (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. …" 10 Section 60 makes provision for review of decisions. It provides:

"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 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 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, except where subsection 28(4) of the Administrative Appeals Tribunal Act 1975 applies, apply for a statement setting out the reasons for the decision reconsideration and may, subject to that Act, make an application to the Administrative Appeals Tribunal 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 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."

The objections to competency 11 The notices of objection to competency filed on behalf of the respondents differentiate between the application for orders of review under the ADJR Act, and the application for prerogative and other relief under s 39B of the Judiciary Act. They also differentiate between the first, second and third decisions.

The first decision 12 The respondents claim, in relation to the first decision, that the applicant is not a person whose interests were affected by that decision within the meaning of that expression in s 60(2) of the Act. 13 They also claim that the applicant is not a person aggrieved by that decision for the purposes of s 3(4) and s 5(1) of the ADJR Act. 14 Finally, the respondents claim that the application for an order of review should be refused because it was filed out of time. 15 Alternatively, the respondents' claim that, for the purposes of the Judiciary Act, the application for judicial review was not filed within a reasonable time.

The second and third decisions 16 The respondents advance similar claims in relation to the second and third decisions. However, it is not suggested in relation to those decisions, that the application for an order of review was filed out of time. Nor is it suggested in relation to those decisions that the application for judicial review was not filed within a reasonable time.

the preliminary questions 17 To complicate matters further, the respondents also filed notices of motion seeking to have various matters identified therein heard separately from, and prior to, the hearing of the other issues in this proceeding. That procedure is available pursuant to O 29 r (2)(a) of the Federal Court Rules ("the Rules"). 18 The respondents also sought to have the applicant's claims dismissed upon the basis that adequate provision is made for merits review of each of the decisions under challenge in this proceeding. They rely in that regard upon s 60(8) of the Act, and generally upon the Administrative Appeals Tribunal Act 1975 (Cth) ("the AAT Act"). 19 In what now appears to have been a clearly misguided effort to avoid a complex and probably lengthy hearing, the parties agreed upon a series of preliminary questions which would be decided separately from any other question and before any trial in the proceeding. 20 The preliminary questions were set out in signed minutes of proposed consent orders filed with the Court. They were in the following terms: "(a) Is the applicant a person whose interests are affected by the decision referred to in paragraph (a) of the application (the first decision) within s 60(2) of the Act? (b) Is the applicant a person who is aggrieved by the first decision within ss 5(1) and 3(4) of the Administrative Decisions (Judicial Review) Act 1977 (the ADJR Act)? (c) Is the applicant a person who is entitled to apply for an order of review under the ADJR Act in respect of the first decision? (d) Does the applicant have standing to apply to the Court for relief under s 39B of the Judiciary Act 1903 (s 39B) in respect of the first decision? (e) Was the applicant entitled, pursuant to s 60(2) of the Act, to request the second respondent to reconsider the first decision? (f) Is the second respondent taken, pursuant to s 60(4) of the Act, to have made the decision referred to in paragraph (b) of the application (the second decision)? (g) Is the second respondent susceptible to review under the ADJR Act? (h) Is the applicant a person who is aggrieved by the second decision within ss 5(1) and 3(4) of the ADJR Act? (i) Is the applicant a person who is entitled to apply for an order of review under the ADJR Act in respect of the second decision? (j) Is the second decision a decision in respect of which relief can be sought under s 39B? (k) Does the applicant have standing to apply to the Court for relief under s 39B in respect of the second decision? (l) Did the third respondent make a decision as alleged in paragraph (c) of the application or as alleged in any (and if so which) of the sub-paragraphs of that paragraph (the third decision)? (m) Is the applicant a person who is aggrieved by the third decision within ss 5(1) and 3(4) of the ADJR Act? (n) Is the applicant a person who is entitled to apply for an order of review under the ADJR Act in respect of the third decision? (o) Does the applicant have standing to apply to the Court for relief under s 39B in respect of the third decision?" 21 It was further agreed between the parties that the preliminary questions should be determined upon the basis of certain assumed facts. These were: "4… (a) on 25 June 2001, the first respondent, as delegate of the predecessor of the fifth respondent, decided, on the application of the fourth respondent, to approve the registration of the product Arrox (paroxetine mesilate) under s 25 of the Therapeutic Goods Act 1989 (the Act); (b) by letter dated 5 July 2001, the applicant made a submission to the Therapeutic Goods Administration (TGA) in the terms of exhibit "RWH-1" to the affidavit of Richard William Hamer sworn 5 February 2002; (c) by letter dated 27 July 2001, the TGA replied to the applicant's letter of 5 July 2001 in the terms of exhibit "RWH-2" to the affidavit of Richard William Hamer sworn 5 February 2002; (d) by letter dated 21 September 2001, the applicant purported to request the Minister for Health and Aged Care to reconsider, under s 60(2) of the Act, the first respondent's decision, in terms of exhibit "RWH-3" to the affidavit of Richard William Hamer sworn 5 February 2002; (e) the period of 60 days after the making of that request expired without any response from the relevant Minister or any delegate of the relevant Minister; (f) by letter dated 30 November 2001, the third respondent, as delegate of the predecessor of the second respondent, purported to refuse the applicant's request of 21 September 2001 and to decide that the applicant did not have standing to make the request, in the terms of exhibit "RWH-4" to the affidavit of Richard William Hamer sworn 5 February 2002; (g) the matters alleged in the following paragraphs of the application, in support of the claim in it that the applicant is aggrieved by the decisions, are true: (i) paragraphs 1A to 8 (inclusive); (ii) paragraph 8A, excluding the last sentence of that paragraph; (iii) paragraphs 8B; and (iv) paragraphs 9 to 11 (inclusive); (h) the following is true: "The release onto the Australian market of paroxetine mesilate without requiring and assessing the usual safety and efficacy data runs counter to the regulatory approach which GSK Australia has consistently recommended and pressed for in its communications with the TGA concerning pharmaceutical regulations, policies and guidelines and the re-writing of the AGDR. Its sets a precedent which, unless reversed, will change the basis on which future exchanges on public safety matters and regulatory issues will take place as between GSK Australia and the TGA"; and (i) the matters alleged in paragraphs 1 to 12 of the grounds of the application (including the particulars thereto) are true. 5. Further, for the purpose of the determination of the preliminary questions: (a) the document entitled "Australian Guidelines for the Registration of Drugs" referred to in paragraph 1B of the application; and (b) the document entitled "Investigation of bioavailability and bioequivalence" at page 149 of The Rules Governing Products of the European Union, volume III, addendum 2, which is referenced in appendix 11 of the Australian Guidelines for the Registration of Drugs, are to be received as agreed exhibits for the purpose of the determination of the preliminary questions." 22 It was agreed between the parties that these assumed facts were not to be regarded as constituting admissions by any of the respondents. Nor were they to be taken as precluding the parties from contesting the accuracy of the assumed facts at any trial of the proceeding.

The misunderstanding between the parties 23 It is clear that by their notices of motion, the respondents were seeking to invoke the procedure under O 29 r 2. From their perspective, what was being done was that certain facts were being admitted for the limited purpose of determining the preliminary questions, much as though they had demurred to a statement of claim. In the event that they failed upon the preliminary questions, their understanding was that they could raise the question of standing again at the trial, by challenging the existence of the assumed facts. 24 Regrettably, the applicant did not view the matter in that way. Its position was that when it agreed to the issue of standing being dealt with upon the basis of the preliminary questions, and upon the basis that the assumed facts were true, that would be the definitive resolution of that issue. 25 The fact that the parties proceeded upon entirely different assumptions regarding the nature of the process being undertaken was unfortunate. It should serve as a salutary reminder of the dangers of proceeding to determine preliminary questions of law without a clear understanding of precisely what that process entails. 26 The applicant submitted, and I accept, that it would not have agreed to proceed by way of preliminary questions had it not believed that the issue of standing would thereby be finally determined. The respondents submitted, and I accept, that they would not have agreed to proceed by way of preliminary questions had they not believed that the issue of standing would remain live, for the trial, if they failed in what was, from their perspective, the equivalent of a demurrer. 27 When it became apparent that the parties were not ad idem, the applicant submitted that the only fair method of resolving the misunderstanding was to treat the respondents' motions as falling to be determined as though they constituted applications under either O 11 r 16, or O 20 r 2, of the Rules. The applicant submitted that given that the respondents were seeking to have the proceeding dismissed in whole or in part (as distinct from merely having particular claims struck out), it was appropriate to treat the respondents as having moved under O 20 r 2. That rule deals with summary dismissal. 28 Order 54 r 6 provides that in applying O 20 r 2 to an application under the ADJR Act, that rule, which provides that a proceeding may be stayed or dismissed where "no reasonable cause of action is disclosed" shall be construed as if O 20 r 2(1)(a) read "no reasonable basis for the application is disclosed." 29 SmithKline submitted, correctly, that it is normal in determining an application under O 20 r 2 to assume the truth of the allegations made by the applicant. That was, in effect, what had been done in relation to the statement of agreed facts set out earlier in these reasons for judgment. I was reminded that a claim for relief will be summarily dismissed as disclosing no reasonable cause of action only where it is so obviously untenable that it cannot possibly succeed: Dey v Victorian Railways Commissioners (1949) 78 CLR 62at 91 and General Steel Industries Ltd v Commissioner for Railways (1964) 112 CLR 125. 30 SmithKline relied upon Douglas v Tickner (1994) 49 FCR 507 where Carr J, at 519-521, dealt with an application by the respondent to summarily dismiss four sets of proceedings before the Court on the basis that the applicants were not "persons aggrieved", and therefore their application could not succeed. His Honour referred to Dey and General Steel, and observed that the power to order summary judgment must be exercised with "exceptional caution" and "should never be exercised unless it is clear that there is no real question to be tried". He also referred to Tooheys Ltd v Minister for Business and Consumer Affairs (1981) 54 FLR 421 at 437, where Ellicott J said that the question whether an applicant was a person aggrieved was one of mixed law and fact, best determined at a final hearing, when all the facts were before the Court. Carr J concluded that the application in Douglas v Tickner should be permitted to go to trial in the ordinary way because it was not apparent the applicants must fail on the "person aggrieved" point. See also Davis v Commonwealth (1986) 61 ALJR 32 where Gibbs J rejected a preliminary challenge to standing upon a similar basis. 31 The respondents replied to these submissions by contending that, although the applicant may have believed that the decision of the Court upon the assumed facts would finally determine the issue of standing, that had never been their position. They had agreed to the assumed facts solely in order that the Court might determine whether, even on the assumption that they were true, the applicant had standing to bring this proceeding. The respondents pointed out, correctly, that I had also approached the matter upon that basis. 32 The issue between the parties is not whether any decision that I now take upon the basis of the assumed facts determines conclusively whether SmithKline has standing. It would be unfair to the respondents to deal with the matter in that way. It is clear that they would not have agreed to invoke O 29 r 2 had they known that they might later be shut out from challenging standing if they were unsuccessful in that challenge at this stage. Rather, the issue to be resolved is whether I should approach the task of determining standing upon the basis of the assumed facts as though this were an application by the respondents to have the proceeding summarily dismissed under O 20 r 2 (as the applicant contended) or whether I should approach that task purely upon the basis that standing should be determined in accordance with the assumed facts (as the respondents contended). 33 The objections to competency are clearly to be decided upon the basis that the assumed facts are true. However, I do not accept the applicant's submission that, in order to overcome these objections, it need only demonstrate that it is arguable that it has standing upon the basis of the assumed facts. 34 Adopting this approach, SmithKline has the advantage of the assumed facts. A decision that those facts are not sufficient to establish standing would be a decision that, putting SmithKline's case at its highest, it cannot meet that threshold requirement. In approaching the matter in this way, I am not persuaded that it is appropriate to treat an objection to competency to an application under the ADJR Act as being "in essence" an application for summary dismissal: cf Douglas v Tickner.

the procedure under order 29 rule 2 35 Order 29 r 2 "provides a useful procedure in certain cases though its usefulness depends upon the obtaining of answers which are likely to make a substantive hearing unnecessary …": TVW Enterprises v Duffy (unreported, Federal Court of Australia, March 1985, per Toohey J). It is generally undesirable to isolate a preliminary question of law when the factual foundation for the determination of that question has not been resolved: Rocklea Spinning Mills Pty Ltd v Anti-Dumping Authority (1995) 56 FCR 406. 36 It was the respondents' contention that a finding that SmithKline lacked standing would make a substantive hearing unnecessary. It was only on that basis that I allowed the preliminary questions to be formulated, and to be dealt with in accordance with the statement of assumed facts. 37 In agreeing to that course, I was mindful of the observations of the majority in Bass v Permanent Trustee Co Ltd (1999) 198 CLR 334 regarding the circumstances in which a court should state or answer preliminary questions. In Bass there was no agreed statement of facts and no findings of facts had been made. Their Honours criticised the practice of giving answers to questions not based on facts found or agreed. They said that such answers were purely hypothetical, and could not assist the efficient administration of justice. They noted that the procedure which had been adopted by the Full Federal Court in that case had been far removed from that traditionally associated with the demurrer, a procedure which, before it became obsolete, assumed the truth of a particular set of facts. 38 What I was not aware of at the time that I was persuaded by the respondents to deal with the issue of standing by way of preliminary questions was that in Director of Fisheries (NT) v Arnhem Land Aboriginal Land Trust (2001) 185 ALR 649, the Full Court had held that it is inappropriate for the Court to answer separate questions based upon agreed facts unless those separate questions resolve the dispute finally between the parties. Separate questions incorporating concepts based upon incomplete facts are also inappropriate to answer. 39 Sackville J, with whom Spender and Merkel JJ relevantly agreed, referred to the warning given by the High Court in Bass against courts providing answers to hypothetical questions or giving advisory opinions. His Honour noted that, in Bass v Permanent Trustee Co Ltd (supra), the majority judgment pointed out (at CLR 355): "… central to those descriptions [of the purpose of a judicial determination] is the notion that such a determination includes a conclusive or final decision based on a concrete and established or agreed situation which aims to quell a controversy." 40 Recently, in Brisbane Airport Corporation Ltd v Wright [2002] FCA 359, Dowsett J observed that where the AAT, under its Act, decides to consider the question of standing as a preliminary issue, that question must be determined finally upon the material then available. 41 Had I appreciated the limitations imposed upon the procedure of answering separate questions based upon agreed facts by the Full Court in Director of Fisheries (NT) v Arnhem Land Aboriginal Land Trust, I would almost certainly not have permitted the parties to embark upon this exercise. A finding that the applicant has standing to bring this proceeding would not resolve that issue to finality, although the converse finding might do so. In these circumstances, I consider that it is inappropriate to answer the preliminary questions. However, having regard to the time and effort which has been expended thus far, I propose to deal with the objections to competency. I will do so upon the basis of the assumed facts agreed between the parties.

the respondents' submissions regarding standing and alternative remedies

The first decision 42 The first decision was made by the Minister's delegate on 25 June 2001. 43 The respondents submitted that the matters relied upon by SmithKline to establish standing in relation to that decision, including the potential harm to SmithKline which the approval of Ausrox might bring about, did not entitle it to request a reconsideration of the decision to register that drug. They accepted that this submission depended upon the meaning to be accorded to the phrase "person whose interests are affected by a decision" in s 60(2) of the Act. They submitted that the construction of that phrase had to be approached by reference to the subject matter, scope and purpose of the Act: Allan v Transurban City Link Ltd (2001) 75 ALJR 1551 at pars 15-16, 53-54 and 64; Alphapharm Pty Ltd v SmithKline Beecham (Australia) Pty Ltd (1994) 49 FCR 250 at 260 and 272 and Byron Environment Centre Inc v Arakwal People (1997) 148 ALR 46 at 48, 62 and 78. 44 The respondents submitted that the Act establishes a statutory scheme for the registration of therapeutic goods, and that its objects are relevantly set out in s 4. Those objects are 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 or exported from Australia.

45 The respondents relied heavily upon Alphapharm in support of their claim that SmithKline lacked standing to challenge the first decision. They submitted that that case had determined that the commercial interests (whether direct or indirect) of a competitor did not give that competitor an entitlement, under s 60(2) of the Act, to request reconsideration of a decision to register therapeutic goods. They contended that Alphapharm made it clear that the Act was concerned with the protection of the public, and not with the market share or profits of companies engaged in competition with an applicant for registration.

46 The respondents referred specifically to the following passage of Davies J, where his Honour noted that the Act was dominated by public interest concerns. He said at 261: "In this context, it is difficult to see that the Act would recognise the interest which a competitor may have in delaying or hindering the introduction of the drug onto the market. Such an interest is not relevant to the process which the Act establishes or to any decision made under the Act. Such an interest is indeed in conflict with the interests which the Act promotes." 47 It is important to note, however, that Davies J went on to say at 263: "… on the material before the Court, SmithKline has not demonstrated that it had a relevant interest entitling it to request reconsideration of the initial decision. The interest which SmithKline has propounded - that of a competitor whose interests would be affected as the drug, it if were registered and placed on the market, would compete with cimitidine and reduce its price - is not an interest which the Act recognises for the purposes of s 60(2). I should add that, if SmithKline had shown a relevant interest, I would not have held it to be disentitled by the fact that the drug had been registered. In my opinion, a decision for the purpose of s 60 encompasses both registration and refusal to register." 48 The respondents relied principally upon the judgment of Gummow J who took a strong stance against an interpretation of the Act which treated a third party as a person interested in, in the sense of opposed to, a grant of registration. His Honour expressed his conclusion as follows at 280-281: "(i) Where the initial decision under s 25 is not to register or to register with conditions, the applicant is a person whose interests are affected thereby, within the meaning of s 60. (ii) Where there has been an initial decision to register which has been acted upon by the effecting of registration, the operation of the Act upon the steps leading up to that registration is spent. (iii) The scope and purpose of the legislation in the above situation does not allow of third parties as persons who have an interest affected by the initial decision to grant registration and who may seek reconsideration and reversal of it under s 60. (iv) Any conditions on registration may be varied or removed and new conditions added by the Secretary at the request of the registered party or on the motion of the Secretary (s 28). (v) The Secretary may cancel registrations, but with prospective rather than retrospective effect (s 30(5)). (vi) It may be that a third party in situations described in (iv) or (v) has "interests" which, within the meaning of s 60, are "affected" by the initial decision there described. (vii) Revocation by the Minister under s 60(3) of an initial decision of the Secretary to cancel under s 30 may attract an application for review by the AAT under s 60(8) at the instance of a third party being one whose interests are affected by the revocation of the initial decision to cancel. (viii) It is unnecessary to decide questions of standing under s 60 as to the situations outlined above in pars (iv)-(vii)." 49 It can be seen, therefore, that the effect of Gummow J's reasoning was to recognise that third parties could be heard in relation to goods registered in the ARTG only in the particular circumstances set out in par (vi) (which picks up pars (iv) and (v)) and par (vii). His Honour's interpretation did not allow for third parties to be heard under s 60(2) by way of application for reconsideration of a decision to register. In that regard, his reasoning stands in stark contrast with that of Davies J. As far as Davies J was concerned, a decision for the purpose of s 60 encompassed both the registration of a product, and the refusal to register. 50 Burchett J, the third member of the Court, found himself in agreement with both Davies J and Gummow J, at least with regard to the fact that the appeals must succeed. His Honour's reasons were brief. Regrettably, he did not indicate which view of s 60 he favoured. 51 It follows, as the respondents acknowledged, that Alphapharm is not binding upon me with regard to the proper interpretation of s 60. However, they submitted that I should follow the approach taken by Gummow J rather than that taken by Davies J. Indeed, their argument largely restated the reasoning adopted by Gummow J. 52 That reasoning is to be found in his Honour's judgment at 273-281. He drew attention to Pt 3 of the Act which establishes the ARTG. He noted that where an application is made, pursuant to s 23, for the registration of therapeutic goods, those goods are to be evaluated in accordance with s 25. Registration effectively enables the sponsor to import and supply the goods without committing an offence under s 20. He said that it was significant that no person, other than an applicant for registration, is entitled to participate in the decision-making process relating to registration. He noted that an application for registration is not notified to the public or to any other person, and that notice of the Secretary's decision is given only to an applicant for registration. It was also significant that reasons for decision are required, pursuant to s 25(3)(a), only where the decision is one not to register the goods. Once a drug has been registered, only limited information concerning that product may be released to third parties. Moreover, given the absence of any requirement for public notification of an initial decision, the time limit on requests for reconsideration under s 60(2) of the Act ("within 90 days after the decision first comes to the person's notice") would be open ended.

53 His Honour also noted that to enable a third party to request reconsideration of a decision to register therapeutic goods would result in uncertainty, creating the possibility that registration might be revoked. That in turn could expose a sponsor of goods, retrospectively, to criminal liability under the offence provisions.

54 The respondents submitted that if, as Alphapharm had determined, a commercial interest based upon a desire to delay or hinder the introduction by a competitor of a drug onto the market was not sufficient to allow a third party to invoke s 60(2), neither was a commercial interest based upon concern about the safety and efficacy of that drug. A concern of that nature would not give rise to an interest greater than, or different from, that of any member of the general public. The safety of the public, and the efficacy of new products, were matters which, under the Act, were committed to the Minister. 55 In relation to the ADJR Act, the respondents submitted that SmithKline was not a "person aggrieved" by the decision to register Ausrox within the meaning of that expression in ss 3(4) and 5(1) of that Act. Section 3(4)(a)(i) relevantly provides that a person aggrieved by a decision includes a reference to "a person whose interests are adversely affected by the decision". The respondents submitted that this formulation was no wider than that adopted in s 60(2) of the Act. 56 The respondents supported that submission by reference to a number of cases dealing with the principles governing standing in public law. They referred, in particular, to Australian Institute of Marine and Power Engineers v Secretary, Department of Transport (1986) 13 FCR 124 at 131; Big Country Developments Pty Ltd v Australian Community Pharmacy Authority (1995) 60 FCR 85 at 92; and Right to Life Association (NSW) Inc v Secretary, Department of Human Services and Health (1995) 56 FCR 50 at 64-65 and 84. They submitted that, in order for an applicant to be "a person aggrieved by a decision", the applicant must have a "special interest in the subject matter of the proceeding". In other words, the applicant must be able to show a grievance which would be suffered as a result of the decision beyond that of an ordinary member of the public. The applicant must have an interest which involves more than a mere emotional or intellectual concern: Australian Conservation Foundation Inc v Commonwealth (1980) 146 CLR 493 at 530-531, 539-540 and 548-549; Onus v Alcoa of Australia Ltd(1981) 149 CLR 27 at 35-37, 41-42, 53 and 74 and Shop Distributive and Allied Employees Association v Minister for Industrial Affairs (SA) (1995) 183 CLR 552 at 558. 57 The respondents submitted that even assuming that all of the allegations made by SmithKline were true, as set out in the agreed facts, it had not established that it was "a person aggrieved" by the decision to register Ausrox. They relied upon the same matters in support of that submission as in relation to their earlier argument regarding the interpretation of s 60(2). They noted, for example, that SmithKline had no entitlement to be heard in relation to that decision. Rather, as a third party, it stood completely outside the decision-making process. It had no knowledge of the reasons for the decision, and no entitlement to access the material upon which it was based. 58 As far as SmithKline's claims under s 39B of the Judiciary Act were concerned, the respondents submitted that it had no standing to seek any of the relief available under that section. They submitted that Bateman's Bay Local Aboriginal Land Council v The Aboriginal Community Benefit Fund Pty Ltd (1998) 194 CLR 247, did not stand for any broader principle. SmithKline had no "special interest" of the type required in order to give it standing to challenge the decision to register. 59 The respondents added that, as far as prohibition was concerned, once the first decision had been made, and Ausrox included on the ARTG, there was nothing left to prohibit.

The second decision 60 The respondents' submission regarding the second decision was brief. They contended that because the applicant was not entitled, pursuant to s 60(2), to request the Minister to reconsider the first decision, its purported request on 21 September 2001 was not a request under that section. Accordingly, it did not give rise to any obligation on the part of the Minister to do so. The respondents also submitted that s 60(4) did not operate to confirm the first decision. The sub-section did not, therefore, give rise to a "deemed decision". Moreover, even if it did, any such deemed decision would not be amenable to review under either the ADJR Act or s 39B. Section 60(4) was intended to do no more than create a deemed "reviewable decision", amenable to an application for merits review to the AAT pursuant to s 60(8). It had no other operation or effect. 61 As the Minister could not be regarded as having made a decision pursuant to s 60(4), there was, in truth, no second decision. Accordingly, SmithKline had no standing to challenge any such decision.

The third decision 62 The respondents submitted that, contrary to SmithKline's claim, all that was decided by the Minister's delegate on 30 November 2001 was that it did not have standing under s 60(2) to request a review of the decision to register Ausrox. Accordingly, the delegate was unable to accede to the request to reconsider that decision. 63 The respondents also submitted that there was no confirmation of the first decision by the delegate because she had not reconsidered that decision. 64 The respondents conceded that SmithKline had standing, in a formal sense, to apply for an order of review under the ADJR Act, and also to apply for judicial review under s 39B, in relation to the delegate's refusal to reconsider the first decision. SmithKline also had standing in relation to the delegate's decision that it had no standing to make such a request. However, they submitted that even if that were so, a finding favourable to SmithKline regarding these matters could not assist it in its challenge to the third decision. That was because SmithKline was not a person whose interests were "affected by [the first] decision" within the meaning of s 60(2). It followed that the third decision was manifestly correct.

Alternative remedies 65 Finally, the respondents submitted that even if, contrary to all of their other contentions, the applicant had standing to bring this application, the Court should, in the exercise of its discretion, decline to permit review. 66 The basis for this submission was that SmithKline had available to it adequate alternative remedies by way of merits review, and judicial review should therefore be refused: s 10(2)(b)(ii) of the ADJR Act; and Swan Portland Cement Ltd v Comptroller-General of Customs (1989) 25 FCR 523 at 530.

the applicant's submissions regarding standing and alternative remedies

The first decision 67 SmithKline submitted that, on the assumed facts, the decision to register Ausrox had been taken, in part at least, upon the basis of information which it had supplied in relation to its own product, Aropax. There had been no evidence that Ausrox was a safe or effective drug. 68 Smithkline further submitted that, on the assumed facts, and on the inferences properly to be drawn from those facts, the first decision had the potential to affect its interests adversely. That was because: · it represented a departure from previous practice, and from the TGA's own guidelines. · it constituted a rejection of the representations consistently made by SmithKline to the TGA that new pharmaceuticals should not be registered without appropriate pre-clinical and clinical trials. · it gave rise to serious safety risks. · it had the potential to undermine public confidence in the drug approval process. · it had the potential to undermine the reputation, integrity and acceptability of Aropax, and thereby cause significant harm to SmithKline. · any adverse reactions to Ausrox would almost certainly be referred to the SmithKline's own adverse reactions monitoring program. It would be difficult, if not impossible, to determine which drug had caused any such reaction; and · SmithKline's ability to monitor the performance of Aropax would be compromised. 69 SmithKline noted that the respondents' primary submission was that it had no standing to seek reconsideration of the first decision, whether by merits review, or by judicial review. There was, therefore, some irony associated with the respondents' alternative submission that judicial review should be refused, in the exercise of the Court's discretion, because of the availability of merits review as an adequate alternative remedy. 70 SmithKline challenged the respondents' submission that, upon the proper construction of s 60, a favourable decision upon an application for the registration of a therapeutic good was conclusive, and immune from all review. It submitted that, on the assumed facts, the first decision was a nullity. Given the adverse effects which that decision might have upon it, the conclusion that SmithKline lacked any recourse, whether by way of merits or judicial review, was one which ought not lightly be reached. 71 SmithKline accepted that the Act made no mention of this Court's jurisdiction. However, it submitted that this was of little consequence in determining whether judicial review was available: Magrath v Goldsborough, Mort & Co Ltd (1932) 47 CLR 121 at 134 where Dixon J said: "The general rule is that statutes are not to be interpreted as depriving superior Courts of power to prevent an unauthorised assumption of jurisdiction unless an intention to do so appears clearly and unmistakably." 72 SmithKline noted that this passage had been referred to and applied by Black CJ as a member of the Full Court in Shergold v Tanner (2000) 102 FCR 215 at 220. In that case the Court held, by majority, that a decision by a Minister to issue a certificate identifying a document as an "exempt document" under the Freedom of Information Act 1982 (Cth) ("the FOI Act") was amenable to judicial review despite the fact that the Act provided that the effect of such a certificate was to "establish conclusively" that such a document was exempt. 73 In rejecting a submission that the relevant decision was not amenable to judicial review, Finkelstein J said at 247: "If the applicant is correct, the fundamental principle that the court will intervene to ensure that the power of a public authority is exercised lawfully (R v Lord President of Privy Council; Ex parte Page [1993] AC 682 at 701) will be defeated." 74 His Honour went on to say at 252: "It is now beyond argument in this country that when a person, such as the Minister, is given power by statute to make a decision that would affect some person by altering his rights or obligations or by depriving him of some benefit or advantage, the decision is amenable to judicial review." 75 In Shergold v Tanner [2002] HCA 19, the appeal from the decision of the Full Court was dismissed. It is noteworthy that the High Court made no criticism of the fact that the respondent in that case sought to challenge, by judicial review, the decisions of the delegate of the Minister to exercise the powers conferred by the relevant sections of the FOI Act, rather than seeking merits review, which was also available. 76 Observations of a similar nature to those expressed by Finkelstein J in the Full Court have also been made by Kirby J in Allan v Transurban City Link Ltd (supra) at par 73 and, in the context of what are described as "the constitutional writs" in Abebe v Commonwealth (1999) 197 CLR 510 at 537. 77 SmithKline challenged the respondents' submission that Alphapharm had established that a favourable decision under s 25 of the Act was not amenable to judicial review. It submitted that the question in that case had been whether, pursuant to s 60, such a decision was amenable to merits review, initially by way of reconsideration by the Minister, and then by way of review by the AAT. The issue of judicial review had not arisen for determination, a fact expressly noted by Davies J at 259-260. Indeed, his Honour observed that the question of standing might be determined differently depending upon whether what was at issue was merits review or judicial review. He said at 260: "This must be so with respect to the phrase "interests are affected", when used in a statute which provides for the administrative review of administrative decisions. In such event, the review, which forms part of the process of administrative decision-making, is provided to promote the achievement of the objects of the statute. The term "aggrieved", when used in the context of judicial review, may have a different connotation, for the object of judicial review is to ensure that the law is observed." 78 The applicant also noted that Davies J had said, at 263, that if SmithKline had demonstrated a relevant interest, it would not have been disentitled by the fact that the drug had been registered. SmithKline had failed, in Alphapharm, because the only interest put forward on its behalf was an interest in "delaying or hindering the introduction of the drug onto the market": see 261-262. Had there been evidence supporting the contention belatedly made from the bar table on its behalf that the use of Alphapharm's product posed risks to its commercial reputation, SmithKline may well have had standing to seek merits review. Importantly, in his Honour's opinion, a decision for the purpose of s 60 encompassed both registration and refusal to register. 79 The applicant submitted that although Gummow J in Alphapharm held that a favourable decision to register was not subject to merits review by a third party, his Honour did not say anything to suggest that such a decision was immune from judicial review. 80 As noted earlier, Burchett J agreed with both Davies J and Gummow J, thereby depriving Alphapharm of any binding authority on this point. 81 SmithKline submitted before me that if the decision to register Ausrox was amenable to judicial review, there was no doubt that it had standing to seek such review. Plainly, it had a "special interest" in the subject matter of the proceeding: Australian Conservation Foundation v The Commonwealth (supra) at 530-531; Onus v Alcoa of Australia Ltd (supra) at 35-36, 41-42 and 74; Davis v Commonwealth (supra); Shop Distributive and Allied Employees Association v Minister for Industrial Affairs (SA) (supra); Bateman's Bay Local Aboriginal Council v The Aboriginal Community Benefit Fund Pty Ltd (supra) at 267; Transurban City Link Ltd v Allan (1999) 95 FCR 553 at 565; and North Australian Aboriginal Legal Aid Service Inc v Bradley [2001] FCA 1728 at pars 28-64. 82 SmithKline submitted that none of the authorities cited by the respondents supported the proposition that, merely because it was a commercial rival of the fourth respondent, it lacked standing. Indeed, there was authority for the contrary view: see Bateman's Bay at 274. 83 For these reasons, SmithKline submitted that, on the assumed facts, it plainly had a "special interest" in the subject matter of the proceeding. That interest was not "a mere intellectual or emotional concern". SmithKline stood to gain an important advantage, apart from the satisfaction of righting a wrong, if its challenge to the first decision were successful. SmithKline had also shown that it might suffer special damage, peculiar to itself, if that decision were permitted to stand. Apprehended harm was sufficient, particularly when the risk of that harm was neither remote nor indirect. 84 SmithKline also submitted that the assumed facts showed that the first decision involved a rejection by the TGA of legitimate representations which it had consistently made over a long period of time regarding public health and safety. Those facts also showed that SmithKline had been denied natural justice. That alone was sufficient to demonstrate that it had standing to seek judicial review: Alphapharm at 260-261 per Davies J and at 266 per Gummow J.

The second and third decisions 85 SmithKline noted that the respondents did not challenge its standing to seek judicial review of the third decision. Whether that decision stood depended upon the success of its challenge to the first decision. 86 In those circumstances, it acknowledged, it was unnecessary to consider whether the second decision was amenable to judicial review.

Alternative remedies 87 SmithKline submitted that if it was a person "affected" for the purposes of s 60, the Minister would be required to reconsider the first decision on the merits. In those circumstances, it was entitled to approach the Court for a determination of the question whether the Minister was so obliged. Putting aside the question whether there was a "deemed decision" to confirm the first decision, SmithKline was not in a position to approach the AAT unless and until it obtained a decision upon reconsideration by the Minister: see the definition of "reviewable decision" in s 60(1) of the Act. 88 SmithKline submitted that it had acted reasonably in instituting this proceeding. Indeed, it had little choice but to do so. The question whether it should be required ultimately to proceed with merits review, rather than judicial review, could be addressed in the light of the Court's answers to the challenge to its standing.

conclusion 89 I have already indicated the approach that I propose to take with regard to the preliminary questions formulated by the parties. Having regard to the decision of the Full Court in Director of Fisheries (NT) v Arnhem Land Aboriginal Land Trust (supra), I consider it inappropriate these questions be answered. That is because the respondents have expressly preserved to themselves the right to re-agitate the issue of standing at the trial of this matter if I reject their contention that, even taking the assumed facts as given, the applicant is not a "person whose interests are affected" by the first decision. The procedure under O 29 r 2(a) can only be used where the answers to separate questions resolve the dispute finally between the parties. 90 As I have already indicated, I propose to deal with the respondents' objections to competency upon the basis that the assumed facts have been demonstrated, but not upon the basis that they are seeking summary dismissal of this application. I am conscious of the fact that a number of the allegations contained in the assumed facts are contentious. In the event that I find that SmithKline has standing on the basis of those facts, there may still be an issue as to whether they have been proved during the course of the trial. 91 In my view, it is impossible to conclude, on the basis of the assumed facts, that SmithKline is not a "person whose interests are affected" by the first decision. It is equally clear, on the basis of those facts, that it is "person aggrieved" for the purposes of the ADJR Act, and that it has "a special interest" for the purposes of s 39B. 92 The assumed facts go well beyond those established in Alphapharm. They demonstrate that SmithKline has had a longstanding and ongoing involvement with the TGA. It has frequently made submissions to that body regarding the principles by which therapeutic goods should be listed in the ARTG. It has also demonstrated that there is a real chance that it may be significantly prejudiced if Ausrox remains registered. 93 I do not regard Alphapharm as requiring SmithKline to be denied standing. The reasoning of Davies J indicates that s 60(2) is not confined to refusals to grant registration, but may also be invoked by aggrieved third parties in circumstances where registration has been granted. That reasoning seems to me to be cogent. 94 In arriving at my conclusion that SmithKline has standing in this matter, I am conscious that aspects of the reasoning of Gummow J in Alphapharm might tend towards the opposite conclusion. I note also that his Honour's approach to the construction of s 60(2) of the Act was broadly endorsed, albeit in the context of a different statute, by the Full Court in Edwards v Australian Securities Commission (1997) 72 FCR 350. That case concerned a decision of the ASC to register a company under the Corporations Law as a foreign company. Persons opposed to that company in litigation applied to the AAT for review of the ASC's decision. They claimed that they were persons "whose interests [were] affected by the decision", within s 27 of the AAT Act. Their application for review was refused upon the basis that their interests were not so affected. It was accepted that the statutory regime in Alphapharm, as reviewed by Gummow J, bore "many similarities to the one under consideration" in Edwards. Alphapharm was described in the headnote as having been "applied". I note, however, that the Full Court made no mention of that fact that Davies J had reasoned in a quite different manner to Gummow J and that Burchett J had agreed with both their Honours. 95 Neither the judgment of Gummow J in Alphapharm, nor Edwards, are directly in point in determining the applicant's standing to seek judicial review in the present case. 96 I shall not revisit in any detail the authorities to which I have already referred in summarising the competing submissions of the parties. It is worth noting however that in Allan v Transurban City Link Ltd (supra) the majority (Gleeson CJ, Gaudron, Gummow, Hayne and Callinan JJ) observed at par 15: "The expression "affected by" and cognate terms appear in a range of laws of the Commonwealth. This is not the occasion for a disquisition on that topic. It is necessary to answer the questions posed … by reference to the subject, scope and purpose of [the] statute, rather than by the application of concepts derived from decisions under the general law respecting what has come to be known as "standing". "Standing" is a metaphor to describe the interest required, apart from a cause of action as understood as common law, to obtain various common law, equitable and constitutional remedies." 97 In my opinion, there is nothing in the text of the Act, or in its subject, scope or purpose, that suggests that a third party whose interests are affected by a decision to register a new product may not request the Minister to reconsider that decision. Section 60(2) commences with "[A] person", words of the greatest generality, and not words such as "[A]n applicant for registration". 98 The policy arguments advanced by the respondents against this interpretation do not lead to the conclusion that the language of the subsection should be given other than its ordinary and natural meaning. 99 Another argument in support of SmithKline's position is that the Act expressly allows for conditions to be attached to any registration of drugs. An applicant for such registration who is aggrieved by any such condition must surely, as a matter of principle, be able to invoke s 60(2) to request the Minister to reconsider that condition. That would be so even where the goods have been registered. 100 It must be borne in mind that the Act is concerned not simply with the timely availability of therapeutic goods, but also with the vital issue of public safety. It seems to me that the Act, upon its proper construction, contemplates that a third party, whose interests are affected by the registration of a competitor's goods, may bring to the notice of the Minister matters affecting public safety by requesting reconsideration of the decision to register those goods. 101 Even if my conclusion that s 60(2) bears this construction is wrong, I am satisfied that, on the assumed facts, SmithKline is "a person aggrieved" for the purposes of ss 3(4) and 5(1) of the ADJR Act. 102 In Attorney-General of the Gambia v N'Jai [1961] AC 617 Lord Denning said, at 634: "… The words "person aggrieved" are of wide import and should not be subjected to a restrictive interpretation. They do not include, of course, a mere busybody who is interfering with things which do not concern him: but they do include a person who has a genuine grievance because an order has been made which prejudicially affects his interests." 103 That passage has been cited with approval on many occasions, and seems to me to represent a correct statement of law. 104 I am also satisfied that, on the assumed facts, SmithKline has a "special interest" sufficient to give it standing in relation to its claims for judicial review under s 39B. 105 There is no basis, in my view, for the Court, in the exercise of its discretion, to decline to entertain an application for judicial review in circumstances where there is doubt as to whether the applicant has standing, under s 60(2) to seek merits review. 106 With regard to the question of delay, I would unhesitatingly exercise my discretion to extend time in this case given the steps taken by SmithKline to protect its rights between the time of the first decision and the time of the second and third decisions. It follows that each objection to competency, and each objection to jurisdiction, must be disallowed. 107 I propose to give the parties an opportunity to file and serve written submissions in relation to the question of costs. I certify that the preceding one hundred and seven (107) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Weinberg.

Counsel for the Applicant: Mr A.L. Cavanough QC with Mr D.J. Batt

Solicitors for the Applicant: Allens Arthur Robinsons

Counsel for the First, Second, Third and Fifth Respondents: Mr P.J. Hanks QC with Mr C. Horan

Solicitor for the First, Second, Third and Fifth Respondents: Australian Government Solicitor

Counsel for the Fourth Respondent: Mr D.K. Catterns QC

Solicitors for the Fourth Respondent: Baldwin Shelston Waters Law

Date of Hearing: 7 March 2002

Date of Judgment: 30 May 2002