SmithKline Beecham (Australia) Pty Ltd v Chipman

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FEDERAL COURT OF AUSTRALIA

SmithKline Beecham (Australia) Pty Ltd v Chipman [2002] FCA 674

ADMINISTRATIVE LAW – standing to sue – meaning of “person whose interests are affected” – Therapeutic Goods Act 1989 (Cth) s 60(2) – meaning of “person aggrieved” – Administrative Decisions (Judicial Review) Act 1977 (Cth) ss 3(4) and 5(1) – whether applicant has “special interest” in subject matter of proceedings – Judiciary Act 1903 (Cth) s 39B – whether a competing commercial interest a relevant interest

PRACTICE AND PROCEDURE – preliminary points and trial of separate issues – questions to be decided separately from any other questions before trial – assumed facts – whether procedure under Federal Court Rules O 29 r 2 appropriate where no finality in relation to issues to be determined

Therapeutic Goods Act 1989 (Cth) ss 4, 25, 60
Administrative Decisions Judicial Review Act 1977 (Cth) s 3(4), 5(1) and 10(2)(b)(ii)
Judiciary Act 1903 (Cth) s 39B
Federal Court of Australia Rules O 29 r 2

Dey v Victorian Railways Commissioners (1949) 78 CLR 62 at 91 referred to
General Steel Industries Ltd v Commissioner for Railways (1964) 112 CLR 125 referred to
Douglas v Tickner (1994) 49 FCR 507 at 519-521 considered
Tooheys Ltd v Minister for Business and Consumer Affairs (1981) 54 FLR 421 at 437 referred to
Davis v Commonwealth (1986) 61 ALJR 32 referred to
TVW Enterprises v Duffy (unreported, Federal Court of Australia, March 1985) referred to
Rocklea Spinning Mills Pty Ltd v Anti-Dumping Authority (1995) 56 FCR 406 referred to
Bass v Permanent Trustee Co Ltd (1999) 198 CLR 334 considered
Edwards v Australian Securities Commission (1997) 72 FCR 350 at 369-370 referred to
Director of Fisheries (NT) v Arnhem Land Aboriginal Land Trust (2001) 185 ALR 649 at 679 applied
Brisbane Airport Corporation Ltd v Wright [2002] FCA 359 at par [43] referred to
Allan v Transurban City Link Ltd (2001) 75 ALJR 1551 at pars [15]-[16], [53]-[54], [64] and [73] referred to
Alphapharm Pty Ltd v SmithKlineBeecham (Australia) Pty Ltd (1994) 49 FCR 250 at 259, 260, 261-262, 263, 266, 272, 273-281 and 275-276 considered
Byron Environment Centre Inc v Arakwal People (1997) 148 ALR 46 at 48, 62 and 78 referred to
Australian Institute of Marine and Power Engineers v Secretary, Department of Transport (1986) 13 FCR 124 at 131 referred to
Big Country Developments Pty Ltd v Australian Community Pharmacy Authority (1995) 60 FCR 85 at 92 referred to
Right to Life Association (NSW) Inc v Secretary, Department of Human Services and Health (1995) 56 FCR 50 at 64-65 and 84 referred to

Australian Conservation Foundation Inc v Commonwealth (1980) 146 CLR 493 at 530-531, 539-540 and 548-549 referred to
Onus v Alcoa of Australia Ltd(1981) 149 CLR 27 at 35-37, 41-42, 53 and 74 referred to
Shop Distributive and Allied Employees Association v Minister for Industrial Affairs (SA) (1995) 183 CLR 552 at 558 referred to
Bateman’s Bay Local Aboriginal Land Council v The Aboriginal Community Benefit Fund Pty…

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Details
Case
[2002] FCA 674
Decision Date

CaseChat Overview and Summary

SmithKline Beecham (Australia) Pty Ltd, an applicant, sought judicial review of decisions made by various respondents regarding the registration of a pharmaceutical product, Arrox (paroxetine mesilate), under the Therapeutic Goods Act 1989. The case involved multiple preliminary questions concerning the applicant's standing to seek review and reconsideration of decisions made by the Therapeutic Goods Administration and the Minister for Health and Aged Care. These questions were framed within the context of statutory provisions for review and reconsideration of decisions under the Act and the Administrative Decisions (Judicial Review) Act 1977.

The court was required to determine whether the applicant had standing to seek review of three separate decisions: the initial decision to register the product, the refusal to reconsider the initial decision, and the decision to confirm the initial decision after the reconsideration period lapsed. Additionally, the court had to assess whether these decisions were subject to review under the applicable legislation and whether the applicant was aggrieved by these decisions. The court also needed to clarify whether the applicant had the requisite standing to apply for relief under section 39B of the Judiciary Act 1903 in relation to these decisions.

The court analysed the statutory framework and the specific provisions concerning review and reconsideration within the Therapeutic Goods Act. It examined the nature of the decisions made and whether they were initial decisions subject to the reconsideration process. The court also assessed the applicant's interests and whether they were affected by the decisions in question. After considering the submissions and the relevant statutory provisions, the court found that the applicant did not have standing to seek review of the decisions under the Act. Consequently, the objections to competency were disallowed, and the matter was referred for further directions concerning costs.

Orders

Orders of the court

1. Each objection to competency, notice of which was filed on 14 January 2002, be disallowed.

2. The parties file and serve written submissions on the question of costs on or before 13 June 2002.

3. The matter be listed for a further directions hearing on 28 June 2002 at 9:30 a.m.

Background

Background to the litigation

Full text does not contain this section.

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

WEINBERG J
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?” 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.”

Ratio Decidendi

Legal Principle Established

Established by: WEINBERG J

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. …” 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