SUDGMENT No. soc Q3 oul ma? CATCHWORDS ADMINISTRATIVE LAW - standing for judicial review of administrative action - meaning of "person aggrieved" - whether incorporated "right to life" association sufficiently aggrieved to challenge decision not to stop clinical trials of therapeutic goods - legislative objects of therapeutic goods legislation. Administrative Decisions (Judicial Review) Act 1977 (Cth) Therapeutic Goods Act 1989 (Cth) Therapeutic Goods Regulations Australian Conservation Foundation v Commonwealth (1980) 146 = i Vv (1981) 38 ALR Australian. Institute of Marine and Power Engineers vy Secretary, Department of Transport (1986) 71 ALR 73 Ogle v Strickland (1987) 71 ALR 41 Broadbridge v Stammers (1987) 76 ALR 334 v inis (1988) 83 ALR 79 f v_Minis (1989) 19 ALD 70 'oO Cs) 8 (1989) 52 SASR 288 (1993) No NG 606 of 1994 Lindgren J 23 September 1994 26 SEP 1994 Sydney FEDERAL Court OF PRINCIPAL REGISTRY IN THE FEDERAL COURT OF AUSTRALIA NEW SOUTH WALES DISTRICT REGISTRY ) No. G 606 of 1994 GENERAL DIVISION ) RIGHT TO LIFE ASSOCIATION (NSW) INC. Applicant AND: THE SECRETARY OF THE . COMMONWEALTH DEPARTMENT OF HUMAN - - SERVICES & HEALTH First Respondent FAMILY PLANNING VICTORIA INC. Second Respondent CORAM: LINDGREN J PLACE: SYDNEY DATE: 23 SEPTEMBER 1994 MINUTE OF ORDER THE COURT ORDERS THAT: (A) The first question for separate decision be answered as follows: 1. Is the applicant a "person aggrieved" within the meaning of the Administrative Decisions (Judicial Review) Act 1977? Answer: No. NOTE: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules IN THE FEDERAL COURT OF AUSTRALIA ) NEW SOUTH WALES DISTRICT REGISTRY ) No. G 606 of 1994 GENERAL DIVISION ) BETWEEN: RIGHT TO LIFE ASSOCIATION (NSW) INC. Applicant AND: THE SECRETARY OF THE - . COMMONWEALTH DEPARTMENT OF HUMAN - SERVICES & HEALTH Piret Respondent FAMILY PLANNING VICTORIA IXC. Second Respondent CORAM: LINDGREN J PLACE: SYDNEY DATE: 23 SEPTEMBER 1994 REASONS FOR JUDGMENT BATURE OF PROCEEDINGS The applicant seeks, in the alternative, pursuant to section 5, 6 or 7 of the Administrative Decisions (Judicial Review) Act 1977 ("the AD(JR) Act") relief in respect of a "decision", "conduct" or "failure to make a decision" respectively, of the first respondent (also called in these reasons, "the Secretary"). According to the application, the relevant decision was one conveyed to the applicant in a letter dated 31 August 1994 from the Acting Secretary, Commonwealth Department of Human Services and Health, and was a "decision .e. not to stop three clinical trials of the drug Mifepristone which are proceeding under Clinical Trial Notification (CTN) Numbers 93/434, 94/137 and 94/138". The applicant conceded that it would have difficulty in relying on "conduct" under s. 6 and in relying on a "failure to make a decision" under s. 7, and made no submissions in respect of those sections. ~Accordingly, the hearing before me proceeded on the basis that the application was for an order of review of a "decision" under section 5 of the AD(JR) Act. The applicant filed a notice of motion on 9 September 1994 seeking an order that the first respondent direct that the clinical trials not be conducted, or if already in progress be stopped, pending the determination of the proceedings. The motion for interlocutory relief came before me for hearing on 15 September 1994. The parties agreed, however, that if the proceedings could be heard on a final basis this year, the application for interlocutory relief should not proceed. I fixed the proceedings for final hearing before me on 26, 27 and 28 September 1994. The parties asked that three questions be determined prior to the final hearing and that the hearing on these three questions occur on the day which had been set aside for the hearing of the interlocutory application, namely 15 September 1994. Since the determination of the questions would not involve any disputed questions of fact, and a determination of them might dispose of the proceedings finally, and not withstanding the absence of a notice of objection to competency under Order 54 rule 4 of the Federal Court Rules, I made by consent, an order under Order 29 rule 2 of the Rules that the following three questions be decided separately from any other question in the proceedings: li. Is the applicant a "person aggrieved" within the meaning of the i Beview) Act 1977? 2. (a) Was there a "decision" by the first respondent within the meaning of section 5 of the Administrative Decisions (Judicial Review) Act 1977 or a "failure [by the first respondent] to make a decision" within the meaning of section 7 of that Act? (b) Was there "conduct" by the first respondent within the meaning of section 6 of the Administrati Decisi (Judicial Revi 1977? 3. Under paragraph (e) of Item 3 of Schedule 5A to the i (Cth), is there a positive obligation on the first respondent to investigate possible breaches of State law? As will appear, until the end of the hearing on 15 September 1994 there was but one respondent, the Secretary, and the words "by the first respondent" have been inserted by me in the quesitons with the parties' consent. These Reasons for Judgment relate to question 1 only. THE HEARING ON 15 SEPTEMBER 1994 On the hearing on 15 September 1994, Mr D F Rofe QC with Mr A J Tudehope of counsel appeared for the applicant and Mr DM J Bennett QC with Mrs A C Bennett of counsel appeared for the first respondent. Mr J M Snowdon, solicitor, sought, and was granted without objection, leave to appear for Family Planning Victoria Inc. At the conclusion of the hearing, when the further course of the proceedings was being discussed, Mr Snowdon applied for an order joining his client as a party. The applicant did not Oppose this, subject to a submission which it would wish to make that it should not, in any event, be ordered to pay the costs of Mr Snowdon's client. As will appear, Mr Snowdon's client had an interest which would be affected by the result of the litigation. I ordered that Family Planning Victoria Inc. be added as second respondent, reserving the right of the applicant to submit that it should not, in any event, be liable to pay the second respondent's costs. On the hearing, the evidence comprised affidavit evidence and documents admitted as exhibits. There was no oral evidence. After the hearing there were short written submissions by the applicant dated 19 "September 1994, by -the first respondent dated 20 September 1994, and by the applicant in reply dated 21 September 1994. It was not in issue that Mifepristone, also known as ""RU486", was within the definition of "therapeutic goods" contained in s 3 of >the Therapeutic Goods Act 1989. ("the Act"). The object of the Act is stated in s. 4 as follows: "4. The object of this Act is to provide, so far as the Constitution permits, for the establishment and maintenance of a national system of controls related to the quality, safety, efficacy and timely availability of therapeutic goods that are: (a) used in Australia, whether those goods are produced in Australia or elsewhere; or (b) exported from Australia." Part 3 of the Act provides for the maintenance of an "Australian Register of Therapeutic Goods". The purpose of the Register is stated in sub-section 17(1) to be that of "compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans." Sub-section 18(1) provides as follows: "(1) The regulations may, subject to such conditions (if any) as are specified in the regulations, exempt : (a) all therapeutic goods, except those included in a class of goods prescribed for the purposes of this paragraph; or (b) specified therapeutic goods; or (¢c) a specified class of therapeutic goods; from the operation of this Part." Sub-Regulation 12(1A) of the Therapeutic Goods Regulations ("the Regulations") provides as follows: "For the purposes of subsection 18(1) of the Act, the therapeutic goods or the classes of therapeutic goods specified in an item in column 2 of Schedule 5A are exempt from the operation of Part 3 of the Act subject to compliance with the relevant conditions specified in column 3 of that Schedule." Schedule 5A is divided into three columns headed "Item No", "Therapeutic Goods" and "Conditions" respectively, and the entries -for Item No.3 are as- follows: "3 Therapeutic goods used (a) before starting to use the solely for experimental goods, the sponsor must purposes in humans notify the Secretary: (1) in a form approved by the Secretary; and (ii) in accordance with the requirements (if any) determined by the Secretary for the form of notification; that the sponsor intends to sponsor a clinical trial using specified goods; and (b) the notification must be accompanied by the relevant notification fee referred to in item 14 or 14A of Schedule 9; and (c) the approval of the goods for this purpose must be given by the sponsor (if the sponsor is conducting the trial), or by the body or organisation conducting the trial for the sponsor, having regard to the advice of the ethics committee that has, or will assume, responsibility for monitoring the conduct of the trial; and (d) the terms of the approval by the sponsor, body or organisation referred to in paragraph (c) must be no less restrictive than the terms advised by the ethics committee; and (@) the Secretary must not, at any times (i) have become aware that to conduct or continue the trial would be contrary to the public interest; and (ii) have directed that the trial not be conducted, or be stopped; and (f) the sponsor (if the sponsor is conducting the trial), - - or the body or organisation - - conducting the trial for the sponsor, must not receive, or have received, advice from the ethics committee that is inconsistent with the continuation of the trial." A "sponsor" is relevantly defined as a person who imports, or arranges the importation of, the goods into Australia. Section 20 of the Act prohibits a sponsor of therapeutic goods from knowingly or recklessly importing them into Australia for use in humans unless they are "registered goods* or "listed goods" in relation to the sponsor or are "exempt goods" (that is to say goods exempted from the operation of Part 3 or 4, or as the case may be, by the Regulations) or are the subject of an approval or authority under s. 19. The Therapeutic Goods Administration ("TGA") within the first respondent's Department ("the Department") received three Clinical Trial Notifications ("CTN's") in relation. to Mifepristone. The first CIN was given by Ian S. Fraser, Associate Professor of Obstetrics and Gynaecology, within the Sydney Centre for Reproductive Health Research, which was apparently a joint initiative of The University of Sydney and the Family Planning Association of New South Wales, under cover of a letter dated 5 August 1993. Professor Fraser gave notice that he would be responsible for the importation of Mifepristone tablets in three different concentrations (200mg, 50mg and 5mg) and that they would be given in single dosages of 600mg, 50mg or 10mg as noted on the CTN form which accompanied his letter. Professor Fraser -advised that he would be importing the tablets directly from the World Health Organisation's Special Program of Research in Human Reproduction in Geneva, and that the study was a multicentre study being organised by the World Health Organisation. Although the letter referred to the enclosed CTN form as an "application for a study", it was not expressed as an application at all, but as a notification. This is consistent with Item 3 in Schedule 5A to the Regulations quoted earlier, which contemplates only a notification to the Secretary. The CTN was in printed form (no doubt provided to interested persons by the TGA) divided into three sections: one headed "To be completed by sponsor", one headed "To be completed by chairperson of Ethics Committee responsible for review of clinical trial application", and a further section also headed "To be completed by sponsor". The first section gave the "sponsor's name" as Associate Professor Ian S. Fraser, and the "Title and aim of the trial/study" as being: "A prospective randomized multicentre study to compare three doses of Mifepristone (600mg; 50mg and 10mg) in emergency postcoital contraception" The "Hospital or Institution" in which the trial was to be undertaken was identified as the "Sydney Centre for Reproductive Health Research" and the "Time schedule for trial/study" was stated as October 1993 (expected start) to the end of 1994 (expected completion). In the second section of the CTN form were boxes titled "Name of Ethics Committee" and "Address of Ethics Committee" followed by boxes for "Chairperson's telephone numbers". The Ethics Committee was identified as "FAMILY PLANNING NSW ETHICS COMMITTEE". The following printed form of certification appeared towards the end of 'this second part -of the form. "I certify that I the undersigned am the chairperson of the Ethics Committee named above, that the Committee operates in accordance with the NHMRC Statement on Human Experimentation and Supplementary Notes and that the Committee has approved the clinical trial as identified above." {NHMRC is an acronym for National Health and Medical Research Council. } - There was provision in a box for the "Signature of Ethics Committee chairperson" below the certification and a signature appeared in it. Against the signature appeared the handwritten date "9/8/93." Below the certification appeared the third part of the form, which, like the first, was headed "To be completed by sponsor." In this part of the form appeared the printed words "Notification fee" and in an adjoining box there was printed a dollar sign against which were typed the digits °90.00". There was provision in a box for a "Signature of sponsor" and a signature appeared there. The TGA acknowledged receipt of the first CTN by letter dated 25 August 1993 to Professor Fraser. This contained, inter alia, the following: *CTN Number: 93-434 Date EC Approval: 9/08/93 Name of EC: Family Planning Assoc EC NSW" The TGA's letter of acknowledgment contained these three substantive paragraphs: "It is noted that approval to conduct this trial was given by the Chairperson of the above Ethics Committee (EC) who has certified that the committee is constituted and operates in accordance with the NHMRC Statement on Human Experimentation and Supplementary Notes. The TGA has not carried out an assessment of the quality, safety and efficacy of this product in connection with this notification. . Please note that in the event that the Secretary becomes aware that to undertake or continue the clinical trial would be contrary to the public interest, he has the authority to direct that use of the drug product(s) for this clinical trial must cease." The gecond CIN was forwarded to the TGA by Professor David L Healy, Chairman of the Monash Medical Centre, Department of Obstetrics and Gynaecology, Monash University, under cover of a letter dated 4 March 1994. That letter was expressed to be an application for "permission to import Mifepristone from the Therapeutic Goods Administration branch for two CIN studies". In the letter, Professor Healy said that he was the sponsor for these studies "with the Family Planning Association of Victoria and the World Health Organisation." The second respondent is the successor to the Family Planning Association of Victoria. The CTN which was enclosed with the letter was in the same form as the first CIN. The first part of this second CTN stated the sponsor's name as "Professor David Healy", and gave the "Title and aim of trial/study" as: "A prospective randomised multi-centre study to compare 3 doses of mifepristone in emergency post-coital contraception." The name of the "Hospital or Institution" in which the trial was to be undertaken was stated as "1. Family Planning Association of Victoria 2. World Health Organisation" The "Time schedule for the trial/study"" was stated to be from 1 March 1994 (expected start) to 1 March 1995 (expected completion). In the second part of the form ("To | be. completed by chairperson of Ethics Committee responsible for review of clinical trial application"), the name of the Ethics Committee was given as "Human Ethics Committee Family Planning Association of Vic." There was a form of certification identical to that in the first CTN. Below this, in the box marked "Signature of Ethics Committee chairperson", appeared a signature and opposite it appeared the date 4 March 1994. In the third part of the form ("To be completed by sponsor") the amount of the "notification fee" was again shown as $90.00. The "Signature of sponsor" was "David L Healy", and the date was 4 March 1994. Although there was not in evidence any letter from the TGA acknowledging receipt of the second CTN, it is reasonable to think that one would have been written in the form of those which were written acknowledging receipt of the first CTN and the third CTN (noted below). It was not in issue that the second CTN was numbered 94/137 by the TGA. Professor David Healy was also the "sponsor" in respect of the third CIN. However, on this occasion, the drug product to be trialled contained as active ingredients, Mifepristone and Misoprostol rather than the former alone. Like the second CTN it was dated 4 March 1994. The "Title and aim of trial/study" differed from those set out in the first and second CIN's. On this occasion, it was: "A multi-centre study of 2 combination regimens of mifepristone plus misoprostol for termination of early pregnancy." As in the case of the second CTN, the name of the "Hospital or Institution" in which the trial was to be undertaken was stated to be "1. Family Planning Association of Victoria 2. World Health Organisation". tae Like the second CTN, this one stated the "Time schedule" for the trial or study as being from 1 March 1994 (expected start) to 1 March 1995 (expected completion), and like it, this one identified the "Ethics Committee responsible for review of clinical trial application" as the "Human Ethics Committee Pamily Planning Association of Vic", contained a certification in the same form signed by the same signatory as Ethics Committee chairperson, provided for payment of the same "Notification fee" of $90.00, and also bore the signature of Professor Healy as "sponsor". The TGA wrote to Professor Healy acknowledging receipt of the third CTN. The letter was in identical form to the letter dated 25 August 1993 to Professor Fraser noted earlier. It contained inter alia, the following: "CTN Number: 94-138 Date of EC Approval: 4/03/04 Name of EC: Family Planning Assoc HEC Vic" By letters dated 7 March 1994 and 10 March 1994 to Professor Healy and Professor Fraser respectively, the TGA granted approvals to the importation of Mifepristone supplied by the World Health Organisation for use in two CIN studies (no doubt CTN 94/137 and CTN 94/138 in the case of professor Healy, and CTN 93/434 in the case of Professor Fraser). Each letter said "Supply may not commence until CTN notification is confirmed." There was also in evidence an undated letter from Dr Edith Weisberg, Research Manager of the Sydney Centre for Reproductive Health Research to the TGA providing the following details of the study in which the Centre would be participating "under the auspices of the World Health - Organisation": "We will be enrolling 150 women in a dose finding study for Mifepristone as a post-coital contraceptive. The women will be enrolled over a 12 month period and randomly assigned to a single administration of Mifepristone in a dose of 600mgs, 50mgs or 10 mgs. The aim of the study is to determine the minimum effective dose for preventing pregnancy after midcycle unprotected intercourse. We have CTN approval File No. 93/19404." It is reasonable to infer "that that letter related to the clinical trial, the subject of the first CTN, that is to say, CTN 93/434. On 20 April 1994, the applicant wrote to the first respondent a letter, the substantive paragraphs of which were as follows: "I refer to the finding in the Supreme Court of New South Wales, Common Law Division by Newman J - 14479/88 - CES and ANOR v Superclinics Australia Pty Ltd and ORS 18/4/94 finding that the criteria used by Dr Edith Weisberg whether an abortion was justified didn't satisfy the law. Dr Edith Weisberg who is the Medical Director of NSW Family Planning is to trial the Drug RU486 is apparently in charge of trials being conducted by the Family Planning Association (see extracts from Page 9 of Judgment - full Judgment will be forwarded to you through the post.) In the light of his Honours's [sic] finding this Association submits that there is a real danger that some or all of the tests would involve illegal abortions infringing Section 83 of the Crimes Act 1990 (NSW) As this matter is of high importance would you kindly let me have a detailed response to my earlier letter to the Customs Service, as well as this letter, as a matter of urgency I am also faxing a copy of my earlier letter to the Customs as well as copies of my earlier letter to the Commissioner of Police. The Right to Life Association (NSW) ask you to take action to prevent importation or alternatively to cancel consent for the drug RU486 to Customs for destruction." The TGA replied on 8 June 1994 asserting that by reason of the terms of Item 3 in Schedule 5A, to the Regulations, the first respondent's approval of the use of the drug RU486 was not required, that "continuing lawful use of the unregistered drug under those circumstances would cease only if the Secretary should direct that the trials be stopped in the event the Secretary becomes aware that the continuation of the trial would be contrary to the public interest", and that "to date, there appears to be no evidence upon which the Secretary could properly determine that continuation of the trial in question would be contrary to the public interest." Prompted, no doubt, by these last words, on 16 August 1994 the applicant wrote a lengthy letter to the first respondent referring to the three CTN's, and asserting that in the opinion of the applicant and of its counsel, the conduct of the clinical trials was "contrary to the law of NSW and Victoria, and, thus, contrary to the public interest." There was supplied, under cover of the letter, an "Executive Summary of Joint Opinion" signed by senior and junior counsel dated 16 August 1994 in which it was stated to be their view that "these trials are contrary to 'the public interest' within Regulation 5A Item 3(e) of the Regulations made pursuant to Section 18 of the Therapeutic Goods Act 1989". The reason given was that the trials "appear to involve persons in the possible commission of offences under s. 83 of the NSW Crimes Act and s. 65 of the Victorian Crimes Act". The document stated that in the opinion of the signatories, "the instructions given to the jury by Menhennitt J in Davidgon's case (1969) and by Judge Levine in Wald's case (1972)" were "flawed" and were "not a correct exposition of the relevant law relating to unlawful abortions as proscribed by those Statutes", but that even if those "instructions" could be considered correct in law, no material had been presented to the Minister or the Secretary which would attract the so- called "defence of necessity" (in this respect the letter cited the decision of Newman J in CES § Anor v Superclinics Australia Pty Ltd & Ors dated 18 April 1994). I digress to note that the reference in the letter to Davidgon's case is a reference to R v Davidson [1969] VR 667 (Menhennitt J). That was not a direction to a jury, but a report of Menhennitt J's ruling given in the course of a trial as to the meaning of "unlawfully" in s. 65 of the Crimes Act 1958 (Vic) by reference to which the admissibility of evidence tendered in the course of the trial was to be tested. The reference to Wald's case is-a reference to R v Wald (1971) 3 DCR (NSW) 25. That was also not a direction to a jury, but a report of the ruling given by Judge Levine sitting as Chairman of Quarter Sessions, on an application on behalf of the accused, at the close of the Crown's case and in the absence of the jury, for a direction of acquittal in which Judge Levine ruled on the meaning of "unlawfully" in s. 83 of the Crimes Act 1900 (NSW). The CES case was an action for damages by a woman arising out of the fact that her pregnancy had not been diagnosed until it was too late for her to have an abortion performed. The covering five page letter put to the first respondent matters relating to "THE DRUG - RU486 AND HOW IT WORKS"; s. 18 of the Act and Regulation 12 of, and Item 3 in Schedule 5A to, the Regulations; section 83 of the Crimes Act 1900 (NSW) and section 65 of the Crimes Act 1958 (Vic); and certain definitions of "miscarriages", "abortion", "embryo", "conception" and "procure". Finally, under the heading "THE SECRETARY'S ROLE AND DUTY", this submission was put: "... should the Secretary, at any stage before the commencement or during the course of the trials, become aware that to commence or continue same would be contrary to 'the public interest', then it is incumbent upon him to make a decision whether or not to diract that the trial not be conducted or stopped." The concluding paragraph of the letter was as follows: "We request that you exercise your authority under Schedule 5A of the Therapeutic Goods Regulations and direct that the use of the drug product, Mifepristone, for these clinical trials cease." The first respondent replied by a letter dated 31 August 1994 which included the following: "The approvals to import mifepristone for use in these trials were given by an officer of my Department subject to the condition that the use of the mifepristone be in compliance with Commonwealth, State and Territory legislation. I have been presented with no evidence that this condition is not being met. Certain abortions are legal in both NSW and Victoria. Your Association has concluded that the abortions being carried out are illegal simply because you do not have evidence on which to make an informed judgment as to whether they are or are not legal. I do not think that such a conclusion is justified. The approvals were granted on the basis that the relevant laws be complied with and until I am presented with evidence to the contrary, I must act on the belief that in fact there is compliance with these laws. You have raised nothing which would warrant my acting to stop the trials." EIRST QUESTION FOR SEPARATE DECISION 1. Is the applicant a "person aggrieved" within the meaning of the Administrative Decisions (Judicial Review) Act 1977? Sub-section 5(1) of the AD(JR) Act provides that "A person who is aggrieved by a decision to which this Act applies ... may apply to the Court for an order of review ... " Sub-section 3(4) provides, relevantly, that a reference to a person aggrieved by a decision includes a reference "to a person whose interests are adversely affected by the decision." The applicant's case for saying that it was a "person aggrieved" was based upon its constitution. I was told from the Bar table, although it was not in evidence, that the applicant was the successor to an unincorporated association which has functioned since 1974. The applicant was incorporated under the Associations . Zncorporation Act 1984 (NSW) with the following objects: "2. (e) (f) (9) (h) (4) (3) (k) (1) (m) OBJECTS The Association shall be benevolent (as provided for under Section 78(1)(a)(11) of the Income Tax Assessment Act), charitable, non- denominational, non-party political with the following objects:- To respect and protect human life from the moment of conception to natural death. To defend the right to life against any threat including but not-limited to abortion, infanticide and euthanasia. To provide for the needs of pregnant women, the fathers of their unborn babies and their families by offering initial and continued counselling, and financial and other support. To awaken a sense of responsibility within the community and initiate and carry out programmes of action directed towards the alleviation of all medical, psychological, social and economic conditions which might lead individuals to deny the right to life. To promote personal and community awareness of the inherent value of each and every human life, irrespective of age, race, colour, sex creed or conduct and irrespective of each person's physical, mental or emotional capacities. To promote personal and community awareness of the absolute value of human life, and the need to protect it at all stages of its development, from the moment of conception through to natural death. To develop and carry out for the above purposes an educational program directed towards legislators who make public policy, and towards opinion leaders who affect the making of public policy; and towards the general public which affects both groups. To promote persuasive programmes to _ influence lawmakers to initiate, maintain and administer laws which defend the right to life. To support financially, or otherwise, persons or bodies or charitable organisations with objects consistent with these objects. To co-operate with other organisations in pursuance of these objects. To establish Branches of the Association throughout the State of New South Wales. To accept gifts and bequests and to raise, borrow and invest monies and acquire assets for the furtherance of its objects. To do all things necessary or incidental to the furtherance of these objects." The constitution provided that the income and property of the applicant should be used solely towards the furtherance of the applicant's objects. Clause 16 provided for dissolution of the applicant, and in particular, provided that upon a resolution being passed by a three fourths majority of members present at a special general meeting in favour of dissolution, all the applicant's funds should be handed over to some registered or exempted charity or charities with similar objectives to those of the applicant. The expression "a person who is aggrieved" in 8s. 5 of the AD(JR) Act has been much considered in the Court. The expression is not to be narrowly construed, and in particular it is not only persons who have a legal interest at stake in the making of the decision who satisfy the description, although the expression requires that the applicant be "specially" affected, whether directly or indirectly, by the decision, and this means at least, affected otherwise than as an ordinary member of the public (Tooheys Ltd v The Minister for Business and Consumer Affairs (1981) 36 ALR 64 (Ellicott J) at 79; Ricegrowers Co-operative Mills Ltd v Bannerman §& Aner (1981) 38 ALR 535 (FCA)/Full Court) at 539-540 (per Bowen CJ and Franki J); and see the discussion of the expression "persons aggrieved" in Coles Myer Ltd v O'Brien (1992) 28 ALD 555 (NSW/CA)). The expression's meaning is "not encased in any technical rules and ... much depends upon the nature of the particular decision and the extent to which the interest of the applicant rises above that of an ordinary member of the public" (Australian Institute of Marine and Power Engineers v Secretary, Department of Transport (1986) 71 ALR 73 (Gummow J) at 81, followed in Broadbridge v Stammers (1987) 76 ALR 339 (FCA/Full Court) at 341). An applicant must have "an involvement with a case greater than the concern of a person who is a mere intermeddler or busybody" but the Act's criterion for standing is not a restrictive one, "the broadest of technical terme has been selected", and "the necessary interest need not be a legal, proprietary, financial or other tangible interest" or be peculiar to the particular applicant (United States Tobacco Co v Minister for Consumer Affairs "and Others (1988) 83 ALR 79 (FCA/Full Court) at 86). The respondents referred to Australian Conservation Foundation yv_the Commonwealth (1980) 146 CLR 493 as authority for the proposition that the applicant did not have a special interest in the subject matter of the proceedings over and above that enjoyed by the public generally, and so did not have locus standi to enforce the performance of a public: duty by the first respondent, according to the general law test. That case related to a proposal to establish and operate a resort and tourist area at Farnborough in central Queensland. The Foundation' commenced proceedings in the High Court for declarations and injunctions and other orders challenging approvals granted under administrative procedures under the Environment Protection (Impact of Proposals) Act 1974 (Cth) and the Banking (Foreign Exchange) Regulations. Relevant objects of the Foundation were as follows: "(i) to make every effort to ensure that the air, land and waters of Australia are used with wisdom and foresight and that competing demands upon them are resolved in the best long-term interests of the nation; (ii) to foster the conservation of the distinctive vegetation and fauna and important natural and archaeological features of Australia." At first instance, Aickin J ordered that the Foundation's statement of claim be struck out and that the action be dismissed on the ground that the Foundation had no locus standi. His Honour said: "... unless a plaintiff is adversely affected in some way to an extent greater than the public generally he may not Maintain an action for an injunction or a declaration in respect of either the validity of a statute or some breach by the executive government or _ statutory authorities in respect of matters of public law and in particular of breaches of statute or regulations." (at 508) The Full Court dismissed the Foundation's appeal by a 3:1 Majority (Gibbs, Stephen, Mason JJ; Murphy J dissenting). The following passage from the judgment of Gibbs J is instructive: " ... the action was not brought by the foundation to assert a private right. It is brought to prevent what is alleged to be a public wrong. The wrong is not one that causes, or threatens to cause, damage to the Foundation, or that affects, or threatens to affect, the interests of the Foundation in any material way. The Foundation seeks to enforce the public law as a matter of principle, as part of an endeavour to achieve its objects and to uphold the values which it was formed to promote. The question is whether, in these circumstances, it has standing to sue. It is quite clear that an ordinary member of the public, who has no interest other than that which any member of the public has in upholding the law, has no standing to sue to prevent 'the violation of a public right or to enforce the performance of a public duty. There is no difference, in this respect, between the making of a declaration and the grant of an injunction. The assertion of public rights and the prevention of public wrongs by means of those remedies is the responsibility of the Attorney-General, who may proceed either ex officio or on the relation of a private individual. A private citizen who has no special interest is incapable of bringing proceedings for that purpose, unless, of course, he is permitted by statute to do so. (at 526) Later in his judgment, Gibbs J distinguished between "a mere intellectual or emotional concern" on the one hand and the kind of "interest" which might ground locus standi on the other: "I would not deny that a person might have a special interest in the preservation of a particular environment. However, an interest, for present purposes, does not mean a mere intellectual or emotional concern. A person is not interested within the meaning of the rule, unless he is likely to gain some advantage, other than the satisfaction of righting a wrong, upholding a principle or winning a contest, if his action succeeds or to suffer some disadvantage, or a sense of grievance or a debt for costs, if his action fails. A belief, however strongly felt, that the law generally, or a particular law, should be observed, or that conduct of a particular kind should be prevented. does not suffice to give its possessor locus standi." (at 530) This passage appears to include an appropriate description of the applicant. The first respondent submitted that the test posed by the expression "a person who is aggrieved" in section 5 of the AD(JR) Act was a more stringent one than the general law's "special interest liable to be affected". I do not agree; cf Australian Institute of Marine and Power Engineers v Secretary, Department of Transport (1986) 71 ALR 73 (Gummow J) at 81; Australian Conservation Foundation v Minister for Resources (1989) 19 ALD 70 (Davies J) at 72. Moreover, in Australian Conservation Foundation v Minister for Resources, Davies J, while acknowledging that the Foundation did not have standing to challenge any decision which might affect the environment, held that it had a special interest in relation to the South East Forests, and certainly in those areas of the South East Forests that were part of the National Estate under 8. 31 of the Australian Heritage Commission Act 1975 (Cth); and see Australian Conservation Foundation Inc v South Australia (1989) 52 SASR 288 (Supreme Court of SA/Jacobs J). The cases emphasise the importance of determining standing in any particular case by reference to the statutory and factual contexts involved in that case. The point was made by Stephen J in Qnus v Alcoa of Australia Ltd (1981) 149 CLR 27 at 42 in these terns: "Thirdly, the distinction between this case and the ACF Cage is not to be found in any ready rule of thumb, capable of mechanical application; the criterion of 'special interest' supplies no such rule. As the law now stands it seems rather to involve in each case a curial assessment of the importance of the concern which a plaintiff has with particular subject matter and of the closeness of that plaintiff's relationship to that subject matter." For its part, the applicant relied, in particular, on the decision of the Full Court of this Court in Ogle v Strickland (1987) 71 ALR 41. In that case there were two applicants, one a priest of the Anglican Church in Australia and the other a priest of the Roman Catholic Church in Australia. The first and second respondents were members of the Censorship Board, constituted under the Customs (Cinematograph Films) Regulations made under the Customs Act 1901 (Cth). The Board granted a licence to the third respondent to import a film called "Je Vous Salue Marie" ("Hail Mary"), approved its registration, and allowed it to be delivered from the control of Customs to be registered. Regulation 13 provided that a film was not to be registered if, in the Board's opinion, it was blasphemous, indecent or obscene. The trial judge held that the priests did not have standing to seek judicial review and dismissed their application. On appeal, all three members of the Full Court held that the appellants were "persons aggrieved". Lockhart J outlined their claim to that status in the following terms: "fhe appellants claim that, as they are ministers of religion, it is their vocation to teach and foster Christian beliefs and that it is part of their duties to reject or repel blasphemy which attacks the very foundation of their faith. They say that their special position as ministers of religion places them in a position different from that of other members of the community and entitles them to sue. That is the question for decision. It falls to be considered in the background of administrative law where the expression "person aggrieved" and other like expressions are used in statutes to define a person's standing to sue." (at 44) His Honour reviewed the authorities on such expressions as "person aggrieved", "person interested", and "person with affected interest"; noted that it had long been recognised that these formulae should not be given a rigid or inflexible meaning and that they derived their meaning and colour from the context -in -which they appeared and -the nature of the particular statute concerned; and concluded that' the appellants were "persons aggrieved" by the Board's decision. It seems to me that the following passage is central to his Honour's conclusion: "The appellants are in holy orders in hierarchical Christian churches. As ministers of religion they are in a special position compared with ordinary members of the public in that it is their duty and vocation to maintain the sanctity of the Scriptures, to spread the Gospel, to teach and foster Christian beliefs and to repel or oppose blasphemy. Blasphemy is the denial of the basic tenets of the Christian faith. The doctrines and teachings of the Christian faith are of "great cultural and spiritual significance" to the appellants (to adopt the language of Stephen J in the QOnys case, supra) and certainly are of no less significance to Christians than were the Aboriginal relics to the Gournditch-jmara community, in the Onug case. The appellants are not meddlers or 'busy bodies'. Nor are they people who have mere intellectual or emotional concern about the film. Their position is therefore different from the position which the High Court perceived the Australian Conservation Foundation to have in the Australian Conservation Foundation case, supra: see also the judgment of Gibbs CJ in Davis v Commonwealth (1986) 68 ALR 18. The decisions impugned in this case have a greater effect upon the appellants than they have upon ordinary members of the public. It is true that the appellants have no special interests in the subject matter of the decision in the sense of legal or equitable rights or proprietary or pecuniary interests, but they are persons aggrieved because to repel blasphemy is a necessary incident of their vocation. To deny them standing would deny an important class in the community an effective means and procedure for challenging decisions of the kind involved in this case." (at 52-53) Fisher J also referred to the appellant's vocation in the following passage: "I attach significance to the fact that as priests and teachers their interest and their activities are not limited merely to professing the Christian faith. Their interest in my opinion extends beyond that of other members of the Christian community whose limited concern could be fairly described as only 'intellectual or emotional', which words were used by Gibbs CJ (CLR at 35 of the Onus case). The vocation and professional calling of the appellants being more than an intellectual or emotional concern requires greater weight to be given to their interest in the subject matter of the film and in the question whether it is blasphemous. They have, in the words of Stephen J, a 'closer proximity' to this subject mater than other members of the community. This interest in my view should be recognised by the courts."(at 43) An emphasis on the appellants' vocation was not essential to the judgment of the third member of the Court. Wilcox J was prepared to accept that the appellants were persons aggrieved by reason of the outrage to their feelings as committed Christians. This emerges from the following passage: "They include claims by the appellants that they hold as tenets of their faith views about God, Jesus Christ and the Virgin Mary which are denied by the subject film. Details of these alleged denials are set out in the affidavit of the second appellant, Rev Fr John O'Neill. Moreover, it is alleged, the denial takes the form of blasphemy. This means, as Lockhart J has explained, that the allegation is that the film makes its denials in such a scurrilous and offensive form as to pass the limits of decent controversy and to outrage the feelings of committed Christians. The appellants are committed Christians. They are susceptible, therefore, to an offence and to an outrage which would not be shared by non-believers. Upon their case they, with other believers, have suffered from the release of the film a damage different in kind from the general damage which is suffered by all members of the community when the law is breached. And this special damage arises out of matters of spiritual concern. As it happens, the appellants are also priests, that is, they are persons who have dedicated their lives and their talents to the propagation of beliefs some of which, they claim, are denied by the film. If it were necessary for them to do so, they would, I think, be entitled in relation to standing to rely upon the frustration of their professional activities which, on their case, the film will occasion. But I prefer not to rest my decision upon this additional factor. It seems to me that the damage they claim to sustain as Christians is enough." (at 59) Implicitly, Fisher J disagreed (see the passage quoted earlier), and Lockhart J refrained from expressing a view on the question whether members of the community who profess the 'Christian faith but who are not ministers of religion or otherwise part of the hierarchy of a Christian denomination, would have standing to bring proceedings of the kind in question. Both the Australian Conservation Foundation case and Ogle v Strickland were considered by a Full Court of this Court in Cameron v Human Rights and Equal Opportunity Commission (1993) 119 ALR" 279 in a manner which, to my mind, resolves that issue. In that case the appellant was a lawyer admitted in Western Australia and Fiji, and had been professionally concerned with the rights of Fijians. The Commonwealth Department of Foreign Affairs and Trade provided scholarships to indigenous Fijian students and ethnic Indian students from Fiji. The departmental policy was to award them on a 50/50 basis to the respective groups. The appellant complained that in its effect this policy set a quota for ethnic Indians and discriminated against Fijians. He complained to the Racial Discrimination Commissioner pursuant to s. 22 of the Racial Discrimination Act 1975 (Cth). The Commissioner took the view that the appellant was not "a person aggrieved" under s. 22. The appellant applied for review under the Judiciary Act 1903 (Cth). Davies J held that the appellant was not "a person aggrieved". His Honour distinguished Ogle v Strickland. Of the appellants in that case, his Honour said this: " ... the applicants in that case were under a duty, by reason of their vocation as priests and teachers of the Christian faith, to challenge a decision of the Censorship Board relating to the importation of a film into Australia which the board had found not to be blasphemous in content. It was as a result of that vocation that the applicants were aggrieved by the decision of the board in a manner and to an extent not shared by the community at large, or, indeed, by other members of the Christian community." (emphasis supplied) (119 ALR 283-4). An appeal to the Full Court of this Court was dismissed. Ina joint judgment with which French J generally agreed, Beaumont and Foster JJ said that whether a person is "aggrieved by [an] act" was a mixed question of fact and law involving an objective test, not a subjective one: " gs. @ person does not qualify merely because he or she feels aggrieved by the act. He or she, in the judgment of the court, must, in truth, be aggrieved by that act" (at 285). Their Honours agreed with Davies J, for the reasons given by his Honour, that Ogle v Strickland should be distinguished, and said that "the direct professional and vocational interest of the applicants in QOgle's case in the subject matter of the litigation did not exist in the present case" (at 288). The applicant submitted that what distinguished it from ordinary .members of the public was that it was organised, and since 1984 incorporated, with objects directly related to the subject matter of the decision sought to be challenged. But to accord the status of a "person aggrieved" for no more reason than this would be to elevate form above substance. It would allow individuals who were opposed to a decision, albeit sincerely and for unselfish motives, to acquire standing to challenge it by the procedure of devising an appropriate form of constitution, and if necessary procuring corporate form. It would, for example, distinguish between the unsuccessful Mr Cameron in Cameron v Human Rights and Equal Opportunity Commission noted above and an incorporated association of individuals organised under a constitution with objects of seeking a more equitable allocation of scholarships to Fijians. In my opinion, the issue of standing is not to be foreclosed by such a formal distinction. A person may qualify as a "person aggrieved" by reason of a combination 'of factors, any one of which alone -may not have given that status; see Australian Institute of Marine and Power Engineers v Secretary. Department of Transport (1986) 71 ALR 73 (Gummow J) especially at 61-82. What factors might qualify the present applicant as a "person aggrieved" over and above its objectives as revealed by its constitution and the emotional and intellectual concern of its members? There is not to be taken into account in the present case the fact that the applicant had some connection with or involvement in a process antecedent to the making of the decision impugned as there was in (Australian Institute of Marine and Power Engineers v Secretary. Department of Transport (1986) 71 ALR 73 (Gummow J) and in United States Tebacco Co v Minister for Consumer Affairs (1988) 83 ALR 79 (FCA/Full Court)). There is not present here either the factor of funding or other recognition by government of the applicant as the representative of a particular public interest involved in the particular issue to which the impugned decision relates, or public acceptance of the particular interest as one calling for protection and representation as was found to exist in (Australian Conservation Foundation v Minister for Resources (1989) 19 ALD 70 (FCA/Davies J) - "The ACF is no mere association of individuals having like views" (at 73). Nor is there a coincidence between the applicant's interest (see its "objects" quoted earlier) and the objects of the Act ("quality, safety, efficacy, and timely availability of therapeutic goods": s. 4 of the Act). In Alphapharm Pty Ltd v Smithkline Beecham (Australia) Pty Ltd (1994) 121 ALR 373 (FCA/Full Court), the issue was whether business competitors of the respondent companies whose drug was registered under the Act had standing to request, under sub-section 60 (2) of the Act, the Minister-to reconsider the decision to register it. The answer depended on whether the competitors were "persons whose interests are affected" by the decision. (It was not submitted in the present case that on the -assumption that there was a decision of the Secretary not to stop the trials which was a decision under Part 3, the Court lacked jurisdiction under the AD(JR) Act on the ground that s. 60 of the Act provides a "code" dealing with the review of such decisions, and it has not been necessary for me to form a view on this issue). The Court unanimously held that the competitors lacked standing because their commercial interests were irrelevant to the public interest with which the Act was concerned. That public interest was described by Davies J as including the objects "to ensure that drugs which are imported are suitable for use for humans in Australia" and "to ensure that drugs which are suitable are registered or listed and become available in Australia for public use as soon as is practicable" (at 385). His Honour said this (at 385): "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." The public interests with which the Secretary was concerned in the present case were those referred to by his Honour' the applicant was not an organisation representing a public interest in the 'quality, safety, efficacy and timely availability" of the drug in question, and did not put submissions to the Secretary related to those matters. Burchett J described the competitors' interests as being "far -.. from the interests with which the Act is concerned" (at 388). Gummow J, after a detailed analysis of the scope and purpose of the Act, and in particular of the provisions in Part 3 for registration 'of --therapeutic ~goods and --cancellation of registration, reached the following conclusion: * ... an interpretation of the legislation which treated a third party as a person interested in, in the sense of opposed to, a grant of registration would not sit well with that object of the legislation which is concerned with the timely availability of therapeutic goods, after evaluation by an expert body and pursuant to a "complex and delicate administrative scheme": cf Block v Community Nutrition Institute (1984) 467 US 340 at, 348," (at 403) In my view, the moral and ethical concern of the applicant is not a public interest with which the Act evinces a concern. While it may be permissible for the Secretary to conclude that continuation of the trials is 'contrary to the public interest" because of moral or ethical considerations, such matters are left by paragraphs (c), (d) and (f) in Item 3 to an ethics committee. The ethics committees referred to operate under the "NHMRC Statement on Human Experimentation and Supplementary Notes 1992" a copy of which was in evidence. The Statement and Notes provide, inter alia, that a research project may be approved and may continue only if an ethics committee is satisfied that the project is acceptable on ethical grounds. If, in favour of the applicant, the "interest" of its members are attributed to it (I should not be taken as saying that this is necessarily a correct approach: see Ngalia Heritage Research Council (Aboriginal Corporation) v Minister for Aboriginal Affairs and Dominion Mining Ltd (unreported, Supreme Court of WA/Anderson J, 6 November 1991)), the members of the applicant are seen to be persons "merely holding a belief that a particular type of conduct should be prevented or a particular law observed" (Alphapharm Pty Ltd v Smithkline Beecham. (Australia) Pty Ltd, at 382 (per Davies J)). The first respondent's refusal to accede to the applicant's request to stop the clinical trials affects its members in no way different from the way it affects ordinary members of the public, except, of course,-in relation to-their emotional and intellectual interest in the subject matter of the decision. Por all the foregoing reasons, I think that the applicant is not a "person aggrieved" within the meaning of the AD(JR) Act, and accordingly I answer the first question, "No". My answers to questions 2 and 3 and the reasons for those answere will be given on a date of which the parties will be advised. I certify that this and the preceding 28 pages are a true copy of the Reasons for Judgment of the Honourable Justice Lindgren Associate: Vlad fe Dated: 23 Sept 1994 Heard: 15 September 1994 Place: Sydney Decision: 23 September 1994 Appearances: Mr D F Rofe QC and Mr A J Tudehope of counsel instructed by O'Hara & Company appeared for the applicant. Mr D M J Bennett QC and Mrs AC Bennett of counsel instructed by Australian Government Solicitor appeared for the first respondent. Mr J M Snowdon of Phillips Fox appeared for the second respondent.