RIGHT TO LIFE ASSOCIATION (NSW) INC v SECRETARY DEPARTMENT OF HUMAN SERVICES & HEALTH and ANOR

RIGHT TO LIFE ASSOCIATION (NSW) INC v SECRETARY DEPARTMENT OF HUMAN SERVICES & HEALTH and ANOR - [1995] FCA 33 - FCA 1995 case summary — Zoe

[11]

The first of the primary Judge's two judgments dealt with question 1 and is reported in (1994) 125 ALR 337. The other judgment of his Honour dealt with questions 2 and 3 and is unreported. In view of his Honour's answers to the questions he ordered that the application be dismissed except as to the question of costs which was reserved for later consideration. The appellant appealed to a Full Court of the Court from his Honour's dismissal of the proceeding, and, in particular, from his answering in the negative the first and third questions. Neither of the respondents to the appeal filed a notice of contention. During the course of argument before us counsel for the Secretary sought leave to cross-appeal from that part of the judgment of Lindgren J. which answered part (a) of the second question in the affirmative, namely, whether there was a decision by the Secretary within the meaning of s. 5 of the ADJR Act. The Court did not decide the motion for leave to appeal during the course of argument because it was raised late during argument and counsel for the Secretary said that he would need to obtain instructions which could not be obtained until the argument had concluded and the Court had reserved its decision. The request was reasonable and we granted it. In accordance with directions of the Court, further written submissions were submitted on behalf of the Secretary and the appellant dealing with the question whether leave to cross-appeal should be granted and with the merits of the cross-appeal. In the result neither respondent consented to or opposed the grant of leave to cross-appeal. Obviously all matters still in issue between the parties concerning the preliminary questions that were decided by Lindgren J. should also be disposed of on this appeal. I am of the opinion that leave to cross-appeal should be granted. Statutory regime Before turning to the questions raised on the appeal and cross-appeal, I shall state the relevant facts and describe the statutory regime to which they relate. The statutory framework is of particular importance in this case because it is central to the determination of all three questions. There are two relevant statutory streams. The source of the first is the Customs Act 1901 which authorizes the making of the Customs (Prohibited Imports) Regulations.) The importation into Australia of goods specified in the Eighth Schedule to these Regulations is prohibited unless the Secretary or an authorized officer has by instrument in writing granted permission to import the goods and the instrument is produced to the collector (reg. 5H(2)). An "authorized officer" means an officer authorized by the Secretary by instrument in writing to be an authorized officer for the purposes of reg. 5H(1). One of the classes of goods specified in Schedule Eight as Item 1 consists of "abortifacients, that is, substances that purport to produce abortion". It is common ground between the parties that mifepristone is an abortifacient falling within Item 1. Permission granted by the Secretary or an authorized officer under reg. 5H shall be subject to such conditions imposing requirements or prohibitions on the person to whom the permission is granted with respect to the custody, use, disposal or destruction of the goods that the Secretary or authorized officer thinks necessary to ensure that the goods are not used otherwise than for the purpose for which the permission is granted (reg. 5H(3)). The Secretary may revoke any permission granted by him or an authorized officer where the person fails to comply with a condition (reg. 5H(4)). Although the evidence is rather sparse on the point, it appears (and the case has proceeded on this basis) that the authorized officer gave permission to the importation of mifepristone for use in three clinical trials subject to the condition "that the use of the mifepristone be in compliance with Commonwealth, State and Territory legislation". The second statutory stream commences with the Therapeutic Goods Act 1989 (Cth) (the TG Act). Section 3 contains a definition of "therapeutic goods"; and it is agreed that mifepristone, also known as "RU486", is within the definition of that expression. The objects of the TG Act are expressed 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."

[12]

The TG Act was amended by the Health and Community Services Legislation Amendment Act (No 2) 1993 (Act No 76 of 1993). It repealed s. 4 as set out above and substituted a section in different terms none of which is materially different from the present s. 4 for the purposes of this case. The new s. 4 has not yet come into operation (it commences on a date to be fixed by proclamation, but that day has not yet been proclaimed (s. 2(2) of Act No 76 of 1993)). Part 3 of the TG Act provides for the maintenance of a register to be known as the Australian Register of Therapeutic Goods, the purpose of which is to compile information in relation to, and provide for evaluation of, therapeutic goods for use in humans (s. 17(1)). Section 18(1) provides that the regulations may, subject to such conditions (if any) as are specified in the regulations, exempt inter alia, specified therapeutic goods or a specified class of therapeutic goods from the operation of Part 3 (s. 18(1)(b) and (c)). It is an offence for a person who is the sponsor of therapeutic goods to knowingly or recklessly import the goods into Australia for use in humans or to supply the goods in Australia for use in humans unless, inter alia, the goods are exempt goods (s. 20(1)(a), (d) and (f)). A penalty of $24,000 is provided for contravention. Other offences are created by Part 3, to which I need not refer. "Sponsor" is defined by s. 3 of the TG Act in relation to therapeutic goods as meaning, inter alia, a person who imports, or arranges the importation of, the goods into Australia, subject to certain exceptions which are not relevant for present purposes. Regulation 12(IA) of the Therapeutic Goods Regulations (the TG Regulations) provides that, for the purposes of s. 18(1) of the TG Act, the therapeutic goods or classes of therapeutic goods specified in an item in column 2 of Schedule 5A are exempt from the operation of Part 3 of the TG Act, subject to compliance with the relevant condition specified in column 3 of that Schedule. Schedule 5A is divided into three columns headed "Item No", "Therapeutic Goods" and "Conditions" respectively. The relevant item is item 3 relating to "therapeutic goods used solely for experimental purposes in humans"; and the conditions which appear under the heading "Conditions" are as follows: "(a)before starting to use the goods, the sponsor must notify the Secretary: (i) 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 (e) the Secretary must not, at any time: (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." It is condition (e) with which this case is directly concerned. Facts The Therapeutic Goods Administration (the TGA), a section of the Department of Human Services and Health (the Department), received three Clinical Trial Notifications (CTNs) in relation to mifepristone. The relevant CTNs were described in detail by his Honour and I need not do more than summarize them. The first CTN was given by letter dated 5 August 1993 from Professor Fraser within the Sydney Centre for Reproductive Health Research, which is a joint initiative of the University of Sydney and the Family Planning Association of New South Wales. 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 administered in single dosages of 600mg, 50mg or 10mg as noted on the CTN form which accompanied the letter. Professor Fraser stated that he would be importing the tablets directly from the World Health Organization's Special Program of Research in Human Reproduction in Geneva and that the study was a multi-centre study being organized by the World Health Organization. The form stated that the sponsor was Professor Fraser and that the "title and aim of the trial/study" was "a prospective randomized multicentre study to compare three doses of mifepristone (600mg; 50mg and 10mg) in emergency postcoital contraception". The form stated that the Sydney Centre for Reproductive Health Research was the hospital or institution in which the trial was to be undertaken and that October 1993 was the expected starting time for the trial or study and that the expected time for completion of the trial was the end of 1994. A certificate appeared on the form signed by the Chairperson of the Ethics Committee of the Family Planning Association of New South Wales stating that the Committee had approved the clinical trials. The second CTN was sent to the TGA by Professor Healy, Chairman of the Monash Medical Centre, Department of Obstetrics and Gynaecology, Monash University under cover of a letter dated 4 March 1994. The letter was expressed to be an application for "permission to import mifepristone from the Therapeutic Goods Administration Branch for two CTN studies". Professor Healy stated that he was the sponsor for the studies "with the Family Planning Association of Victoria and the World Health Organization". The letter stated that the Human Ethics Committee of the Family Planning Association of Victoria was the relevant Ethics Committee responsible for reviewing the trial. Family Planning Inc (Vic) (Family Planning) is the second respondent to this proceeding. It is the successor to the Family Planning Association of Victoria. Family Planning was found by his Honour to have an interest which would be affected by the result of the litigation. No party has disputed that finding. The third CTN was sent to the TGA, also by Professor Healy. On this occasion the drug product to be trialled contained as active ingredients, mifepristone and misoprostol. Like the second CTN, the third was dated 4 March 1994. Unlike the first and second CTNs, the title and aim of the trial/study was said to be "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 said to be the Family Planning Association of Victoria and the World Health Organization. The time scheduled for the trial or study was stated to be from 1 March 1994 to 1 March 1995; and the same Ethics Committee was identified with this trial as was identified with the second CTN. By letters dated 7 and 10 March 1994 addressed to Professor Healy and Professor Fraser respectively, the TGA granted approval to the importation of mifepristone supplied by the World Health Organization for use in the studies. On 20 April 1994 the appellant wrote a letter to the Secretary asking him to take action to prevent the importation or, alternatively, to cancel consent for the use of the drug mifepristone on the basis that there is a real danger that some or all of the tests would involve illegal abortions, which was said to infringe s. 83 of the Crimes Act 1900 (NSW). The TGA replied on 8 June 1994 stating that the Secretary's approval was not required and that the trials would not be stopped unless the Secretary directed that they be stopped in the event that he became aware that the continuation of the trials would be contrary to the public interest. It was said that to date there appeared to be no evidence upon which the Secretary could properly determine that the continuation of the trial in question would be contrary to the public interest. By letter dated 16 August 1994 the appellant wrote to the Secretary (this is a critical letter) asserting that, in the opinion of the appellant and of senior and junior counsel retained by it, the conduct of the clinical trials was "contrary to the law of NSW and Victoria and, thus, contrary to the public interest". A summary of a joint opinion of senior and junior counsel was enclosed which stated that in their view the trials were contrary to the public interest within regulation 5A item 3(e) of the Regulations made pursuant to s. 18 of the TG Act on the ground that the trials appear to involve persons in the possible commission of offences under s. 83 of the Crimes Act 1900 (NSW) and s. 65 of the Crimes Act 1958 (Vic). The Secretary was requested by the letter to exercise his authority under Schedule 5A of the Regulations to direct that the use of mifepristone for the clinical trials should cease. The Secretary replied by letter which appears to be undated but was received on 31 August 1994. It included the following statements; "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 has not been 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 judgement 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. While the broad issue that you have raised of compliance with the law concerns all three trials, I should point out that the specific issue of whether illegal abortions are being performed is relevant to only one trial (CTN 94/138) as the other two relate to the use of mifepristone as an emergency post-coital contraceptive not an abortifacient." Is there a positive obligation or duty imposed on the Secretary under paragraph (e) of Item 3 of Schedule 5A to the Regulations to investigate possible breaches of State law (question 3)? Although logically this question does not arise first, it is convenient to deal with it because it has a real bearing on the other two questions. For example, if, contrary to his Honour's finding, there is a positive duty on the Secretary to investigate possible breaches of State law, this would lend assistance to the argument of the appellant that there was a "decision" by the Secretary (question 1) and that it is a "person aggrieved" within the meaning of the ADJR Act (question 2). So it is to this question that I shall now turn. The first point to be made is that the language of condition (e) of Item 3 in Schedule 5A to the Regulations is not that of obligation or duty. This must work against the contention that the Secretary is subject to a positive obligation to investigate possible breaches of State law or anything else that may relate to the public interest. But the legislative scheme of which condition (e) is a part is one which prohibits sponsors of therapeutic goods from knowingly or recklessly importing such goods into Australia for use in humans or supplying the goods in Australia for use in humans unless relevantly the goods are exempt goods or the subject of an approval or authority under s. 19 (s. 20(1)). Hence, under the regulations, to qualify for a relevant exemption from this prohibition, each of the elements of Item 3 set out in Schedule 5A to the Regulations must be satisfied before the exemption can operate. So the starting point for an analysis of condition (e) is that the importation of mifepristone is prohibited unless one of the relevant exemptive conditions (including condition (e)) applies. It does not follow, however, that when the sponsor gives notice of his intention to sponsor a clinical trial using relevant specified goods, that the Secretary has an obligation cast upon him to determine whether the conduct or continuation of the trial would or would not be contrary to the public interest. It was argued on behalf of the appellant that one would expect to see somewhere in condition (e) some obligation cast on the sponsor to justify a departure from the norm of prohibition of the goods which it is sought to import or supply in Australia for use in humans. However, the answer to this lies in my view in conditions (c), (d) and (f) of Item 3 which involves the relevant Ethics Committee. The first of these conditions is that the sponsor or other body or organization conducting the trial is required to have regard to the advice of the Ethics Committee that has or will assume responsibility for monitoring the conduct of the trial (condition (c)). Secondly, the terms of the approval by the sponsor or other body or organization must be no less restrictive than the terms advised by the Ethics Committee (condition (d)). Thirdly, the sponsor conducting the trial or the body or organization 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 (condition (f)). Thus, one important element of public interest considerations is the responsibility of the Ethics Committee. It must be remembered that condition (e) is separate from conditions (c), (d) and (f), each of which involves the Ethics Committee in one form or another. The matters which may be appropriate for the Ethics Committee to consider under those conditions may also fall within the ambit of the public interest to which the Secretary may have regard under condition (e). There may in other words be an overlap; but the presence of condition (c), (d) and (f) involving the role of the Ethics Committee, in particular a monitoring role, with respect to the conduct of the trial, argues against the notion that condition (e) imposes some form of positive obligation upon the Secretary to investigate matters that may be contrary to the public interest. The second point which suggests that there is no positive obligation on the Secretary, as suggested by the appellant, is that, even though in some cases a contravention of State law may or would be committed by the conduct or continuation of a trial or experiment of the relevant therapeutic goods for experimental purposes in human beings, it does not necessarily follow that it would also be contrary to the public interest within the meaning of the regulations. As the primary Judge observed, and I agree with him, an investigation into whether importation or use of relevant therapeutic goods might lead the Secretary to think that contravention of State or Territorial law was being committed, would not necessarily compel a conclusion that continuance of the clinical trials was contrary to the public interest within the meaning of condition (e). The public interest is a concept of wide meaning and not readily delimited by precise boundaries. Opinions have differed, do differ and doubtless always will differ as to what is or is not in the public interest. It is not difficult to find examples in history where laws on the statute book have become outmoded and crimes that were theoretically grave crimes punishable by heavy penalties were in fact rarely, if ever, the subject of prosecution because the thinking of society had undergone a change which had not yet found its way into legislative reform. Merely to say that State (or Territory) law may be infringed if the drug mifepristone is used in the conduct of experiments with respect to human beings would be a criminal offence under State law does not necessarily conclude the question of public interest. Importation of drugs, their distribution and use are activities which in our federal system of government involve regulation by large numbers of criminal statutes and legislative and executive bodies designed to enforce those statutes, in addition to the common law. It would be a highly impracticable and inconvenient task for the Secretary to be responsible for the investigation and consideration of possible breaches of criminal law generally. Also the Federal Government and the Governments of the States and Territories have extensive and elaborate means of enforcing the administration of the criminal justice system and therefore protecting the public interest through police forces, the various public investigative and prosecuting authorities and the courts themselves. I see no reason to construe condition 3 of Item 3 as imposing upon the Secretary some obligation or duty to engage a parallel inquiry into the criminal law or its enforcement. Also, as the trial judge observed, in my opinion correctly, possible breaches of State law are matters for the State prosecuting authority. As his Honour put it: "It cannot be assumed that any contravention of any law of any State is necessarily contrary to the Australia public interest, or, concomitantly, that it is necessarily in the Australian public interest that every contravention of every law of every State be prosecuted".

[14]

Although the form of s. 4 that is proposed pursuant to Act No 76 of 1993 (which has not yet relevantly come into operation) differs from its present form there is no difference in any material respect so far as the present case is concerned. Matters relevant to the public interest, so far as the Secretary's consideration of that question under condition (e) is concerned include matters going to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia wherever produced. The criminal law of New South Wales and Victoria is not concerned with those questions. Section 83 of the Crimes Act 1900 (NSW) and s. 65 of the Crimes Act 1958 (Vic) provide that it is a criminal offence to unlawfully administer to, or cause to be taken by, any woman, any noxious thing with intent to procure her miscarriage. There is a debate as to whether the relevant criminal statutes which prohibit unlawful abortion apply in circumstances where the abortion is necessary in the interests of the health of the mother. No necessary or useful purpose is served by examining that question further. In my opinion the concept of public interest which is encased in condition (e) of Item 3 is directed to questions of public interest that are related to quality, safety, efficacy and timely availability of therapeutic goods used in Australia whether imported or not. Sections 83 of the New South Wales Crimes Act and s. 65 of the Victorian Crimes Act are directed to different matters. In the result I am satisfied that the primary judge did not err in his conclusion that there was no positive obligation on the Secretary to investigate possible breaches of State law. Before leaving this question I make a final observation. There may be some circumstances where a positive duty is cast upon the Secretary to seek material which otherwise would not be before him, bearing on the question whether the conduct or continuance of an experiment using therapeutic goods for experimental purposes in human beings would be contrary to the public interest. This question is for another case. The appeal on this question therefore fails. Was there a "decision" by the Secretary within the meaning of s. 5 of the ADJR Act? (Question 2) The primary Judge found that the Secretary's letter received on 31 August 1994, though not expressed as a decision not to direct that the trials be stopped, nevertheless communicated a final disposition by him of the appellant's request. Moreover, it indicated that the Secretary had considered and dealt with the appellant's submissions in its letter dated 16 August 1994. His Honour held that the decision (to direct or not to direct that the trials be stopped) was "an ultimate or operative determination which an enactment authorises or requires, and thereby gives ... statutory effect": and he referred to General Newspapers Pty Limited v Telstra Corporation (1993) 117 ALR 629 per Davies and Einfeld JJ. at 634. He said that, rather than declining to respond to them, by his letter dated 31 August, the Secretary deliberated upon matters raised in the appellant's letter of 16 August 1994. His Honour found that, the Secretary's statement in his letter received on 31 August "You have raised nothing which would warrant my acting to stop the trials", was a final "refusing to give a direction" under condition (e)(ii) of Item 3 of Schedule 5A to the Regulations, and so was a decision under that sub-paragraph and therefore a decision by the Secretary within the meaning of s. 5 of the ADJR Act. Under the Customs (Prohibited Import) Regulations, importation into Australia of abortifacients is prohibited unless the Secretary or an authorized officer grants permission to import them. The permission may be subject to conditions with respect, inter alia, to the use of the abortifacients and indeed such conditions as the Secretary or authorized officer thinks necessary to ensure that they are not used otherwise than for the purpose for which permission is granted. The TG Act prohibits the sponsor of therapeutic goods importing them into Australia for use in humans or supplying them in Australia for use in humans unless they are exempt goods or are the subject of an approval of authority under s. 19 (s. 20(1)). The work done by Reg. 12(1A) of the Regulations and Schedule 5A Item 3 is to cause the relevant goods to be exempt from the operation of Part 3 of the TG Act subject to compliance with the conditions specified in Schedule 5A, as mentioned above. Hence, prima facie, it is contrary to law to import or use in Australia, mifepristone in the absence of the requisite authority or permission from the Secretary or an authorized officer unless the relevant conditions set out in Schedule 5A Item 3 are satisfied. Condition (e) of Item 3 is not expressed in language that requires the Secretary to do anything. For the condition to operate, the Secretary must not have become aware that to conduct or continue the trial would be contrary to the public interest and not have directed that the trial not be conducted or be stopped. Sub-conditions (i) and (ii) of condition (e) are in my view interrelated. First, the direction given by the Secretary under condition (e)(ii) cannot, in my view, be given unless he has become aware of the matters with which condition (e)(i) is concerned. Thus, condition (e)(ii) cannot operate unless agitated by condition (e)(i). A mere awareness of the Secretary that to conduct or continue a trial would be contrary to the public interest leads nowhere unless it is followed by the Secretary giving a direction that the trial not be conducted or be stopped. Condition (e)(i) is necessarily dependant upon condition (e)(ii) in that for an awareness of the kind to which (e)(i) is directed to have any relevance or effect at all, it must be followed by a direction under (e)(ii).

[15]

It does not necessarily follow that the circumstances in which a direction may be given under (e)(ii) are dependant solely upon the requirements of (e)(i) being satisfied. It is not necessary to decide that question. Condition (e) is not couched in terms of an obligation imposed upon the Secretary; but it assumes a negative, namely, an absence of the requisite awareness in sub-condition (i) and the absence of a direction in sub-condition (ii). As mentioned earlier, there may be circumstances (the present case does not give rise to them) where the Secretary may be under an obligation to consider certain matters in order to reach a conclusion as to whether or not a trial would be contrary to the public interest and whether a direction should be given that the trial not be conducted or stopped. I shall not pause to consider this further as it is unnecessary to do so on the facts of this case. As I said previously, although the relevant Ethics Committee is plainly involved in relation to conditions (c), (d) and (f), its role is essentially to monitor the conduct and continuance of a trial. Nevertheless, the Secretary is the guardian of the public interest under condition (e). If he becomes aware of matters or circumstances which would lead him to conclude that to conduct or continue the trial would be contrary to the public interest, how can he ignore them, even if he may have been under no duty to have made himself aware of them in the first place? But where matters and circumstances have been brought to his attention which relevantly bear on the question of the public interest and he then proceeds to form an opinion and reach a conclusion with respect to them, it seems to me that he may have made a reviewable decision under the ADJR Act. Whether he has done so or not depends very much upon the circumstances of the particular case. No general or "hard and fast" rule can be laid down. In the present case, the appellant brought various matters to the attention of the Secretary bearing upon the question of the legality under State law of the conduct or continuation of the trials with respect to the drug mifepristone. The Secretary regarded them as relevant and reached a conclusion in my view that he would not give a direction under condition (e)(2) to stop the trials. That is the sensible and practical analysis of the Secretary's letter received on 31 August 1994. If the Secretary had reached the opposite conclusion, namely, that to continue the trials would be contrary to the public interest and that a direction should be given to stop them, and thereupon gave that direction, surely that must be a reviewable decision under the ADJR Act. The sponsor would clearly be a person aggrieved and would in my view be entitled to seek a review of the decision under the ADJR Act. Why should the position be different if the Secretary reaches the opposite conclusion, as he did in this case? The answer does not lie in my opinion in the mere form of condition (e)(i) as to absence of awareness on the part of the Secretary and the absence of a direction under condition (e)(ii). By saying in the letter received on 31 August that "I have been presented with no evidence that this condition is not being met" (3rd paragraph, last sentence) and "You have raised nothing which would warrant my acting to stop the trials" (4th paragraph, last sentence), he made a decision refusing to give a direction under paragraph (e)(ii) of Item 3. In the ADJR Act, a reference to the making of a decision includes a reference to doing or refusing to do a relevant act or thing [ADJR Act, s. 3(2)(a), (b) and (g)]. It was a decision which had "the character or quality of finality"; it was an ultimate or operative decision: Australian Broadcasting Tribunal v Bond (1990) 170 CLR 321 per Mason C.J. at 336 and 338. See also General Newspapers Pty Limited v Telstra Corporation, supra, at 634 per Davies and Einfeld JJ. We were referred by counsel for the Secretary to the judgment of Northrop J. in Brownsville Nominees Pty Limited v Federal Commissioner of Taxation (1988) 19 FCR 169 as authority for the proposition that there was no "decision" within the meaning of s. 5 of the ADJR Act because there was no duty imposed on the Secretary to make such a decision. Brownsville is not authority for that proposition. In that case the applicant sought an order pursuant to s. 7(1) of the ADJR Act for a review of the alleged failure of the Commissioner of Taxation to decide whether to issue, under s. 170 of the Income Tax Assessment Act 1936 amended assessments to the applicant in respect of three years of income. The applicant sought an order directing the Commissioner to make a decision whether amended assessments should be made in respect of each of the income years. Section 7(1) of the Act provides in effect that where a person has a duty to make a decision to which the ADJR Act applies and the person has failed to make that decision, a person who is aggrieved by that failure may apply to the Court for an order of review in respect of the failure. Northrop J. held that the whole purpose of s. 170 is to confer a power on the Commissioner to make amended assessments and the section does not impose any duty on him whatever. Section 170 (in particular s. 170(6)) does not require a decision to be made "under an enactment" for the purposes of s. 3(1) of the ADJR Act. His Honour's judgment is not authority for the general proposition that there can be no decision within the meaning of s. 5 if there is no duty to make such a decision. His Honour's decision was based squarely upon the duties imposed upon the Commissioner under the Assessment Act. Is the appellant a "person aggrieved" within the meaning of the ADJR Act? It is said against the appellant that it lacks standing to bring this proceeding because it has no interest beyond that of an ordinary member of the public. Questions of standing rarely arise in cases involving the determination of private rights. It is in civil cases where the public interest is involved that questions of standing arise. The most important decision upon which the meaning of the expression "person aggrieved" turns is the judgment of the High Court in Australian Conservation Foundation Incorporated v Commonwealth (1980) 146 CLR 493. It was not a case involving the ADJR Act, but much of what was said by their Honours, both Aickin J. at first instance and on appeal to the Full Bench of the High Court, applies in the present case. The Australian Conservation Foundation challenged the validity of certain decisions relating to the Banking Foreign Exchange Regulations and to administrative procedures under the Environment Protection (Impact of Proposals) Act 1974 (Cth) in the context of a proposal by a company to establish and operate a tourist resort in central Queensland. Aickin J. held (at 508) that the Foundation had no standing to sue because it was not "adversely affected in some way to an extent greater than the public generally". Gibbs J., one of the members of the Bench who sat on the appeal said at 530-1: "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, other than a sense of grievance or a debt for costs, if his action fails. I believe, 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. If that were not so, the rule requiring special interest would be meaningless. Any plaintiff who felt strongly enough to bring an action could maintain it."

[21]

In Tooheys Limited v Minister for Business and Consumer Affairs (1981) 54 FLR 421 Ellicott J. said at 437-8: "The words 'a person who is aggrieved' should not in my view be given a narrow construction. They should not, therefore, be confined to persons who can establish that they have a legal interest at stake in the making of the decision. It is unnecessary and undesirable to discuss the full import of the phrase. I am satisfied from the broad nature of the discretions which are subject to review and from the fact that the procedures are clearly intended in part to be a substitution for the more complex prerogative writ procedures that a narrow meaning was not intended. This does not mean that any member of the public can seek an order of review. I am satisfied, however, that it at least covers a person who can show a grievance which will be suffered as a result of the decision complained of beyond that which he or she has as an ordinary member of the public. In many cases that grievance will be shown because the decision directly affects his or her existing or future legal rights. In some cases however the effect may be less direct. It may affect him or her in the conduct of a business or may, as I think is the case here, affect his or her rights against third parties (cf Robinson v Western Australian Museum (1977) 16 ALR 623; 138 CLR 283)." These observations of Ellicott J. are apt in the present case. See also Australian Institute of Marine and Power Engineers v Secretary, Department of Transport (1986) 13 FCR 124 per Gummow J. at 130-134; Broadbridge v Stammers (1987) 16 FCR 296 and see the judgment of Davies J. in Australian Conservation Foundation v Minister for Resources (1989) 19 ALD 70 at 72. The meaning of "a person aggrieved" is not encased in any technical rules; 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. The applicant's interest must not be remote, indirect or fanciful. The interest must be above that of an ordinary member of the public and must not be that of a mere intermeddler or busybody. The ADJR Act has selected in ss. 5 and 6 as its criterion for standing the expression "a person aggrieved". The word "interest" is not used in ss. 3 and 5. The term a "person aggrieved" is not a restrictive one; it is of very wide import. Plainly the applicant need not have a legal, financial or proprietary interest in the subject matter of the proceeding. The applicant must establish that he is a person who has a complaint or grievance which he will suffer as a consequence of the decision beyond that of an ordinary member of the public. In order that an applicant may show that he is a person "aggrieved", the element of "grievance" must be special to the applicant. He must suffer more greatly or a different way than other members of the community. It is to be noted that the definition of "a person aggrieved" by a decision is inclusive of a person whose interests are adversely affected by the decision. It is not exhaustive and the extent of its ambit will depend on the interpretation that the courts place on the expression in the light of the "intention to be gathered from the provision as a whole": Y Z Finance Co Pty Limited v Cummings (1964) 109 CLR 395 at 402; applied in Buckle v Josephs (1983) 47 ALR 787 at 792-3. It is not enough that the person establishes the satisfaction of righting a wrong or upholding a principle or winning a battle if the action succeeds or will suffer some disadvantage other than a mere sense of loss or grievance or a debt for costs if the action fails: Australian Conservation Foundation case at 530. It is sufficient that the applicant has a special interest in the preservation of a particular environment: Australian Conservation Foundation case at 530. Also cultural, spiritual and historical interests may suffice: Australian Conservation Foundation case at 547. But the applicant must establish that if successful in the proceeding he will gain a benefit or advantage greater than the benefit or advantage thereby conferred upon ordinary members of the public; or, in the alternative, that success in the proceeding would relieve the applicant of a disadvantage or detriment to which he would otherwise have been subject to an extent greater than ordinary members of the public: Onus v Alcoa per Brennan J. at 75. Speaking generally, the concern of one or more individual citizens to protect the environment is not of itself sufficient to confer standing. Australian courts, notably the High Court in its judgment in the Australian Conservation Foundation case, have closed the door to the principle of open standing. The effect of the locus standi rule is to exclude some people from obtaining relief from the courts in declaring and enforcing the law in circumstances where others could obtain that relief. Neither Australian nor any other country of which I have knowledge has a completely open system in civil law in the sense that anyone can obtain a ruling from a court on any subject upon which the person desires a ruling. For example, a system where a person can obtain a declaration that another person had committed a crime or where A can seek a declaration as to whether B is indebted to C. The general rule is that a person can obtain relief from a court in civil cases only if the person is interested in the sense which I have mentioned earlier. Lord Diplock argued the case for an open system in which anyone could obtain a declaration or ruling from a court on any subject. In Inland Revenue Commissioners v National Federation of Self-Employed and Small Businesses Ltd [1982] AC 617 at 644 his Lordship said:

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It is imperative in a democratic society such as ours that bodies such as the appellant are entitled to pursue objects of this kind in the exercise of their right of free speech, just as it is equally important that bodies advocating the contrary point of view have an equal right to pursue their objects. But it does not follow that the right to speak and to influence opinions of the public and of politicians may be transmuted into a right of standing to pursue proceedings in courts of law. Wide and liberal though the laws of standing should be, the courts of this country have drawn the line of demarcation between an open system and the requirement of some form of interest in the subject matter of the proceeding other than a mere emotional attachment or intellectual pursuit or satisfaction. The precise ambit and content of this interest is in a state of flux, as Sackville J. noted in North Coast Environment Council Incorporated v Minister for Resources, unreported, 16 December 1994 at 22. There is another powerful reason which argues against the appellant having the requisite standing in this case. The TG Act is the source of the regulations. It is not an Act directed to the wide social issue of the right to life or the permissibility of abortion. It does not seek to resolve the debate on the question whether allowing the abortion of a foetus is to sanction the murder of a human being or to ensure the reproductive freedom of women. These important and deep moral and political questions are not addressed by the TG Act or the regulations, yet these are the very questions which are central to the existence of the appellant. Much has been written on these questions and the legal position of the foetus: see for instance the note by Andrew Grubb and David Pearl "Warding an Unborn Child", [1988] Cambridge Law Journal, 362; K Mark McCourt, "Foetus Status After R v Sullivan and Lemay" (1991) 29 Alberta Law Review 916 (where the Supreme Court of Canada dealt with the issue of foetal rights in a context not directly related to the abortion controversy); Natasha Cica, "The Inadequacies of Australian Abortion Law" (1991) 5 AJFL 37; Moira L McConnell, "Sui generis: The Legal Nature of the Foetus in Canada" (1991) 70 Canadian Bar Review, 548; Glanville Williams, "The Foetus and the Right to Life" (1994) Cambridge Law Journal 71; Susan Watson, "The Rashomon of Science: The Legal Position of the Foetus in New Zealand" (October 1994) New Zealand Law Journal 388 and the work "Feminist Jurisprudence" edited by Patricia Smith, OUP, 1993, in particular Chapter 4 "On Freedom: Restriction, Regulation and Reproductive Autonomy". Section 4 of the TG Act states its object in terms previously mentioned which in essence provide for the establishment and maintenance of a national system of controls relating to the "quality, safety, efficacy and timely availability of therapeutic goods" that are used in Australia wherever produced or exported from Australia. Section 4 of Act No 76 of 1993 which repealed s. 4 of the principal Act and substitutes another s. 4 is, as mentioned earlier, not yet in operation but the objects of the Act just stated are essentially the same. The decision of the Secretary made under condition (e) of Item 3 of Schedule 5A to the regulations is a decision made in the statutory context of the TG Act which has those objects. Nothing advanced by the appellant to the Secretary in support of its argument that he should stop the trials of mifepristone is based on matters relating to the "quality, safety, efficacy and timely availability" of mifepristone or any other drug. The expressed concern of the appellant was that the conduct or continuance of the trials may be contrary to the criminal law of New South Wales or Victoria. Nor are the objects of the appellant directly related to the objects of the TG Act. Alphapharm Pty Limited v Smithkline Beecham (Australia) Pty Limited (1994) 49 FCR 250 is an interesting example of a case where a corporation was held to lack standing under s. 60(2) of the TG Act. Section 60 made provision for a review of certain decisions of the Secretary by a person whose "interests are affected" by the relevant decision. The Full Court of this Court held that the corporation lacked standing because its commercial interests were not relevant to the public interest to which the TG Act was directed. In my opinion the appellant has no greater interest in the subject matter of the Secretary's decision which is impugned in this case than any concerned person might have. If the appellant's argument is correct, anyone having such concern would have standing. The grievance of the appellant does not travel beyond that which any person has as an ordinary member of the public. Here there is only an intellectual, philosophical and emotional concern. The appellant is not affected in any way to an extent greater than the public generally. There is no advantage likely to be gained by the appellant if successful in the proceeding nor disadvantage likely to be suffered if it fails. The most that it can achieve is the satisfaction of correcting a wrong decision if it should succeed and winning a contest which may improve its position in persuading the public and politicians of the correctness of its cause. The appellant has not established that it is a "person aggrieved" within the meaning of s. 5 of the ADJR Act. In my opinion the appellant should pay the costs of the respondents of the appeal as the appellant has failed on the major questions raised in the appeal and the order of the primary Judge dismissing the application stands.

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(1) Failure by the Secretary to observe the procedures required by law in that connection, namely, to inquire whether the trials were contrary to the public interest since there may have been criminality involved. (2) Error of law by the Secretary, inter alia, by failing to determine that the drug was being used as "an emergency post-coital contraceptive"; and that by stating that the drug was not being used as an abortifacient, the Secretary thereby implied that no criminality was involved. (3) An improper exercise of the powers conferred by the Act and the Regulations. Right to Life claimed, inter alia (a) a declaration that in the trials the drug was being used as abortifacient and were thus contrary to the public interest; (b) a declaration that the conduct of the trials involved breaches of s.83 of the Crimes Act 1900 (NSW) and s.65 of the Crimes Act 1958 (Vic); and (c) an order that the Secretary further consider his decision according to law. THE EVIDENCE IN SUPPORT OF THE APPLICATION In support of its application, Right to Life's solicitor swore an affidavit to the following effect: (1) Right to Life was incorporated under the Association's Incorporation Act 1984 (NSW) as a "benevolent ..., charitable, non-denominational, non-party political" association with the following, inter alia, objects: "(a)to respect and protect human life from the moment of conception to natural death. (b) To defend the right to life against any threat including but not limited to abortion, infanticide and euthanasia. (c) 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. (d) 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. (e) 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. (f) 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. (g) 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. (h) To promote persuasive programmes to influence lawmakers to initiate, maintain and administer laws which defend the right to life. ..." (2) By letter dated 5 August 1993, Professor Ian Fraser of the Sydney Centre for Reproductive Health Research (a joint initiative of the University of Sydney and The Family Planning Association of N.S.W.) wrote to the Drug Evaluation Branch ("DEB") Therapeutic Goods Administration ("TGA") of the Department informing it that (as "sponsor") he was responsible for the importation of the drug; and enclosing a form of Clinical Trial Notification ("CTN") in respect of a "trial/study", part of a multi-centre study organised by the World Health Organisation, having the following title and aim: "A prospective randomised multicentre study to compare 3 [oral] doses of Mifepristone [600 mg; 50 mg and 10 mg] in emergency postcoital contraception." (It was common ground at first instance that the drug was "therapeutic goods" for the purposes of the Act.) (3) By letter to Professor Fraser dated 25 August 1993, the Secretary of TGA acknowledged DEB's receipt of the "notification, to conduct a clinical trial under the ... (CTN) Scheme, pursuant to Schedule 5A of Regulation 12 of the Therapeutic Goods Regulations ... ." (It is convenient to note, at this stage, some aspects of the relevant legislative scheme. By s.18(1) of the Act, it is provided as follows: "18. (1) The regulations may, subject to such conditions (if any) as are specified in the regulations, exempt:

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(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." By Regulation 12(1A), it is provided as follows: "(1A) For the purposes of subsection 18(1) of the Act, the therapeutic goods or 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." Item 3 in Schedule 5A lists "therapeutic goods used solely for experimental purposes in humans" as therapeutic goods exempt from the operation of Part 3 of the Act subject to the following conditions: "(a)before starting to use the goods, the sponsor must notify the Secretary: (i) 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 (e) the Secretary must not, at any time: (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; [Emphasis added] 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.") (4) The letter dated 25 August 1993 went on to say: "It is noted that approval to conduct this trial was given by the Chairperson of the above Ethics Committee (EC) [Family Planning Association EC NSW] who has certified that the committee is constituted and operates in accordance with the NHMRC [National Health and Medical Research Council] 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." (As has been said, Professor Fraser stated that, as sponsor, he was responsible for the importation of the drug. By Regulation 5H of the Customs (Prohibited Imports) Regulations, it is provided as follows: "5H. (1) In this regulation, `authorized officer' means an officer authorized by the Secretary of the Department of Health, Housing and Community Services by instrument in writing to be an authorized officer for the purposes of this regulation. (2) The importation into Australia of goods specified in the Eighth Schedule to these Regulations is prohibited unless the Secretary of the Department of Community Services and Health or an authorized officer has, by instrument in writing, granted permission to import the goods and the instrument is produced to the Collector. (3) A permission under this regulation shall be subject to such conditions imposing requirements or prohibitions on the person to whom the permission is granted with respect to the custody, use, disposal or destruction of the goods, as the Secretary of the Department of Health, Housing and Community Services or authorized officer, as the case may be, thinks necessary to ensure that the goods are not used otherwise than for the purpose for which he grants the permission. (4) Where: (a) a permission granted under subregulation (2) is subject to a condition to be complied with by a person; and (b) the person fails to comply with the condition; then the Secretary of the Department of Health, Housing and Community Services may revoke the permission whether or not the person is charged with an offence under subsection 50(4) of the Act in respect of the failure to comply with the condition." Item 1 in Schedule 8 is as follows: "Item No. Description of Goods 1 Abortifacients, that is, substances that purport to produce abortion.") (5) By letter to Professor Fraser dated 10 March 1994, an officer of DEB said: "I refer to your application to import Mifepristone, supplied by the World Health Organisation for use in a CTN study, CTN No. 93/434. In accordance with the provisions of Regulation 5H(2), Eighth Schedule, of the Customs (Prohibited Imports) Regulations, approval is given for the importation and use of Mifepristone Tablets in compliance with Commonwealth, State and territory legislation. This approval remains valid until 1 March 1996. Details of the (total) quantities imported and used should be forwarded to this office on 1 March 1995 and 1 March 1996. Supply may not commence until CTN notification is confirmed. You should show this letter to Customs to effect importation." (6) By letter to DEB dated 4 March 1994, Professor David L. Healy of the Department of Obstetrics and Gynaecology, Monash Medical Centre, Monash University, applied (as "sponsor") for permission to import the drug for two CTN studies as the sponsor of the studies with the second respondent, the Family Planning Association of Victoria and the World Health Organisation. Two CTNs were enclosed. The title and aim of one study was stated to be: "A prospective randomised multi-centre study to compare 3 [oral] does [10 mg, 50 mg, 600 mg) of mifepristone in emergency post-coital contraception."

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The title and aim of the other study was stated to be: "A multi-centre study of 2 combination [oral] regimens of misepristone [200 mg or 600 mg] plus misoprostol [400 micrograms] for termination of early pregnancy." (7) By letter dated 7 March 1994, an officer of DEB wrote to Professor Healy in respect of both studies giving approval in the same terms as the letter to Professor Fraser dated 10 March set out above. (8) By letter to DEB dated 20 April 1994, the appellant claimed that the tests would involve illegal abortions and asked for action to be taken to prevent importation of the drug, or alternatively, "to cancel consent for the drug ... to Customs for destruction." (9) By letter to the appellant dated 8 June 1994, the Director of DEB said: "... 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. 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. The trial is being conducted under the auspices of the World Health Organisation, which is also supplying the drug for the purposes of the trial. My understanding is that the drug is being trialled in New South Wales for its indication as a contraceptive. As required under the clinical trials notification scheme, the trial is oversighted by the ethics committee of the institution involved in the trial, constituted and operating in accordance with guidelines laid down by the National Health and Medical Research Council. The drug company, Roussel Uclaf, is not involved. On the basis that under the Act supply of RU486 in the circumstances outlined above is not unlawful, there would not appear to have been any reason why an import permit could not have been properly issued under R.5H of the Customs (Prohibited Imports) Regulations to enable the products to be imported for use in the abovementioned trial. Until there is evidence that the supply of the product for the trial places the public at risk, or that the conduct of the trial is unlawful, there would not appear to be any ground for cancelling the import permit issued, even if this should be possible." (10)By letter to the Secretary dated 16 August 1994, Right to Life, for several reasons then advanced, made this request: "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." (11) The Acting Secretary of the first respondent replied to the appellant by letter dated 31 August 1994 as follows: "You have stated that it is the opinion of your Association and of your Counsel that the conduct of the three clinical trials of mifepristone (CTN 93/434, CTN 94/137 and CTN 94/138) is contrary to the law of NSW and Victoria and, thus, contrary to the public interest. You have requested me to use my powers under the Therapeutic Goods Regulations to stop the trials. 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. While the broad issue that you have raised of compliance with the law concerns all three trials, I should point out that the specific issue of whether illegal abortions are being performed is relevant to only one trial (CTN 94/138) as the other two relate to the use of mifepristone as an emergency post-coital contraceptive not an abortifacient." FURTHER ASPECTS OF THE LEGISLATIVE SCHEME Reference has previously been made to s.18(1) of the Act which, as has been seen, empowers the Regulations to exempt certain therapeutic goods from the operation of Part 3 of the Act. That part deals with the Australian Register of Therapeutic Goods and some other matters. In order to place this provision in context, reference should be made to certain further aspects of the relevant legislative scheme. The object of the Act is stated by s.4 to be: "4.(1) The object of this Act is to promote the development of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods used in Australia or exported from Australia, whether the goods are produced in Australia or elsewhere. [Emphasis added] (2) The provisions made by this Act are intended, as far as the Constitution permits, to impose those controls forming part of the national system that are appropriate to be imposed by legislation of the Commonwealth. (3) It is the intention of the Parliament that the other controls forming part of the national system be imposed by the laws of the States, of the Australian Capital Territory and of the Northern Territory. (4) This Act is therefore not intended to apply to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory to the extent that the law is capable of operating concurrently with this Act." The interpretation of the provisions of the Act is relevantly dealt with by s.3(1) as follows: "Therapeutic goods" means goods, inter alia, that are represented in any way to be, or that are likely to be taken to be: (i) for "therapeutic use"; or (ii)for use as an ingredient or component in the manufacture of the manufacture of therapeutic goods. "Therapeutic use" means use in or in connection with, inter alia, "influencing, controlling or preventing conception..." "Sponsor", in relation to therapeutic goods, includes a person who imports, or arranges the importation of, the goods into Australia. As has been said, Part 3 of the Act deals, inter alia, with the Australian Register of Therapeutic Goods. By s.17(1), the Secretary is to cause to be maintained the Register for the purpose of compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans. As has been noted, s.18 deals with exempt goods. By s.19(1), the Secretary may grant an approval to a person for, inter alia, the importation into Australia, or the supply in Australia, of specified therapeutic goods that are not either exempt goods, or goods included in the Register, for use in the treatment of another person, or for use solely for experimental purposes in humans. Offences by sponsors are dealt with by s.20. By s.20(1) - "20. (1) A person who is the sponsor of therapeutic goods must not knowingly or recklessly: (a) import the goods into Australia for use in humans; or (b) export the goods from Australia for use in humans; or (c) manufacture the goods for supply in Australia for use in humans; or (d) supply the goods in Australia for use in humans; unless: (e) the goods are registered goods or listed goods in relation to the person; or (f) the goods are exempt goods or are the subject of an approval or authority under section 19. Penalty: $24,000." By s.20(3) - "(3) Where: (a) the importation or exportation of goods is prohibited under subsection (1); and (b) the Secretary notifies the Comptroller-General in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation; the goods are, for the purposes of that Act, to be taken to be prohibited imports or prohibited exports, as the case may be." By s.21 - "21. A person must not knowingly or recklessly supply in Australia therapeutic goods for use in humans (other than listable devices), being goods of which the person is not a sponsor, to another person who is not the ultimate consumer of the goods unless: (a) the goods are registered goods or listed goods; or (b) the goods are exempt goods or are the subject of an approval or authority under section 19. Penalty: $12,000." General offences relating to Part 3 are dealt with by s.22. By s.22(8) - "(8) A person must not knowingly or recklessly use therapeutic goods that are not either exempt goods or goods included in the Register: (a) for use in the treatment of another person; or (b) for use solely for experimental purposes in humans; except in accordance with an approval or authority under section 19. Penalty: $6,000." THE DETERMINATION OF THE PRELIMINARY QUESTIONS At the request of the parties, Lindgren J. ordered that, prior to the final hearing, the following three questions be determined: "1. Is [Right to Life] a person aggrieved' within the meaning of the [AD(JR) Act]? 2(a) Was there a decision' by the [Secretary] within the meaning of s 5 of the [AD(JR) Act] or a failure [by the Secretary] to make a decision' within the meaning of s 7 of that Act? (b) Was there conduct' by the [Secretary] within the meaning of s 6 of the [AD(JR) Act]? 3. Under para (e) of Item 3 of Sch 5A to the Therapeutic Goods Regulations (Cth), is there a positive obligation on the [Secretary] to investigate possible breaches of State law?" Lindgren J. held that Q.1 should be answered in the negative; that Q.2(a) should, as to "decision", be answered in the affirmative; and as to "failure to make a decision", answered in the negative; that Q.2(b) be answered in the negative; and that Q.3 be answered in the negative. His Honour then made an order dismissing the application save insofar as it sought an order for costs. THE REASONING OF THE PRIMARY JUDGE

"Person aggrieved" In holding that Right to Life was not a "person aggrieved" for the purposes of the AD(JR) Act, Lindgren J. said (125 ALR at 348) that an appropriate description of Right to Life's position could be found in the observations of Gibbs J. in the Australian Conservation Foundation case (1980) 146 CLR 493 (at 530) as follows: "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, other than 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." Lindgren J. went on to say (at 352) that there could not to be taken into account in the present case the fact that a party had some connection with or involvement in a process antecedent to the making of the decision impugned as was the position in the Australian Institute of Marine and Power Engineers case (1986) 71 ALR 73 and in the United States Tobacco Co case (1988) 83 ALR 79. There was not present here either the factor of funding or other recognition by government of Right to Life as the representative of a particular public interest involved in the particular issue to which the impugned decision related, or public acceptance of the particular interest as one calling for protection and representation as was found by Davies J. to exist in the Australian Conservation Foundation v Minister for Resources (1989) 19 ALD 70. Nor, his Honour said, was there a coincidence between Right to Life's interest in terms of its stated objects and the objects of the Act - "quality, safety, efficacy, and timely availability of therapeutic goods" in s.4 of the Act."
A "decision" In holding, in a subsequent (unreported) judgment in this matter, that a relevant "decision" had been made, Lindgren J. said (at 9-10): "Upon satisfaction of sub-paragraph (e)(i) of Item 3, sub-paragraph (e)(ii) authorises the making of a decision to direct or not to direct that the trials be stopped. Such a decision is one which the Regulations provide for' in the sense that it is one which they require or authorise' .... Moreover that decision has the character or quality of finality' .... The decision (to direct or not to direct that the trials be stopped) is an ultimate or operative determination which an enactment authorises or requires, and thereby gives ... statutory effect' .... Rather than declining to respond to them, by his letter dated 31 August 1994, the first respondent deliberated upon matters raised in the applicant's letter dated 16 August 1994. The letter said You have raised nothing which would warrant my acting to stop the trials.' In my opinion this was a final refusing to give a ... direction' under sub-paragraph (e)(ii) of Item 3 and so was a decision under that sub-paragraph and therefore a decision by the first respondent within the meaning of s. 5 of the AD(JR) Act, just as a decision after the same deliberation to give such a direction would have been."

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A positive obligation to investigate possible breaches of State law? The primary Judge noted (at 10), in holding that there was no such obligation, that paragraph (e) of Item 3 was not expressed in terms of obligation; rather, it was expressed as a description of two conditions: (i) the Secretary's awareness; and (ii) the Secretary's giving of a notice. No obligation should, his Honour felt, be implied from the textual or other context. It followed that there was no positive obligation on the Secretary "to investigate possible breaches of State law". There were two further reasons, his Honour said (at 10-12), why there was no such obligation: (1) Investigation, even if it were to lead the Secretary to think that contraventions of State law were being committed, would not necessarily compel a conclusion that continuance of the clinical trials was "contrary to the public interest" within the meaning and for the purposes of paragraph (e); (2) Also, the role of the "ethics committees" should be taken into account. After referring to the National Health and Medical Research Council "Statement on Human Experimentation and Supplementary Notes 1992" and, in particular, its recommendation that research institutions establish an institutional ethics committees, Lindgren J. said (at 16): "Questions of the sanctity of human life and of the unlawful administering of a drug with intent to procure the miscarriage of a woman are matters with which the ethics committees can properly concern themselves. At least, the existence, composition and role of the ethics committees constitute a further reason why it is impossible to say that the first respondent is obliged to investigate a possibility, drawn to his attention, of contraventions of s. 83 of the Crimes Act 1900 (NSW) and s. 65 of the Crimes Act 1958 (Vic)." THE APPEAL AND CROSS-APPEAL Right to Life now seeks to challenge the first and third of his Honour's conclusions stated above. For his part, the Secretary now seeks leave to cross-appeal, being out of time, from the second of the primary Judge's conclusions. In the absence of any suggestion of prejudice to Right to Life by reason of the lapse of time involved, leave to cross-appeal should be granted. It should be noted that, in any event, leave might have been necessary for the further reason that this particular order appears to be interlocutory, both in form and in substance. Since the substantive aspects of the conclusion reached by Lindgren J. on the question whether a "decision" was made appear to bear upon the issue of standing (at least), it is appropriate that, for this reason also, leave be granted to the Secretary to cross-appeal from the order giving an affirmative answer to Q.2(a). CONCLUSIONS ON THE APPEAL AND CROSS-APPEAL By s.5(1) of the AD(JR) Act, "[a] person who is aggrieved by a decision to which [the] Act applies ... may apply to the Court for an order of review in respect of the decision on any one or more of the ... grounds [there specified]."

[33]

By s.3(4), an interpretation provision, a reference to "a person aggrieved by a decision" includes a reference, inter alia, "to a person whose interests are adversely affected by the decision." In order to determine whether Right to Life was a "person aggrieved" for the purposes of s.5(1), it is first necessary to identify the relevant "decision" within the meaning of the AD(JR) Act, if any, by reference to which Right to Life was "aggrieved". As Lindgren J. noted, by s.3(2) of the AD(JR) Act, it is provided that a reference to "the making of a decision" includes a reference to, inter alia, "(b) ... refusing to give a ... direction ..."; by s.3(1), the "decision" must be "a decision of an administrative character made, proposed to be made, or required to be made ... under an enactment ..."; for the reasons given in Australian Broadcasting Tribunal v Bond (1990) 170 CLR 321, to fall within the AD(JR) Act, the decision must have "the character or quality of finality" (at 336) so that, as explained in General Newspapers Pty. Ltd. v Telstra Corporation (1993) 117 ALR 629 (at 634), it can be said that the decision is "an ultimate or operative determination which an enactment authorises or requires, and thereby gives ... statutory effect." It will be recalled that, relevantly, the legislative scheme is to this effect. By s.18(1) of the Act, authority is conferred upon the Governor-General to make regulations exempting therapeutic goods from Part 3 of the Act, subject to such conditions, if any, as are specified in the Regulations. For this purpose, by Regulation 12(1A) certain of such goods are so exempt "subject to compliance with the relevant conditions specified ... [in Schedule 5A]". One of those conditions is that: "(e)the Secretary must not, at any time: (i) have become aware that to conduct or continue ... [a clinical] trial would be contrary to the public interest; and (ii)have directed that the trial not be conducted or be stopped." Although para.(e) is in form expressed as a condition, it clearly confers upon the Secretary the power, in certain circumstances, to direct that a trial not be conducted or stopped. I agree with Lindgren J. that a decision to exercise that power would be a "decision" within the meaning of the AD(JR) Act. That is not, of course, the present case. No such decision was made here. But again I agree with the primary Judge that a final refusal to give such a direction also constituted such a "decision". There can be no doubt that in its letter dated 16 August 1994, Right to Life requested such direction. The reply dated 31 August made it clear that it had been decided not to give it. That decision was not expressed to be provisional only or to be otherwise qualified. It was a final and ultimate decision not to give the direction. In my opinion, as an administration decision under the Regulations it fell within the scope of s.5(1) of the AD(JR) Act as a decision under the "enactment". (The latter term is defined by s.3(1) to include a decision under "an instrument (including ... regulations ... ) made under ... an Act ...".) On behalf of the Secretary, it is submitted that there could be no "decision" within s.5 unless there was a duty to make a decision. Reliance is placed upon the reasoning in Brownsville Nominees Pty. Ltd. v Federal Commissioner of Taxation (1988) 19 FCR 169. I have difficulty accepting the submission. In the first place, as has been noted, the definition of "decision" in s.3(1) of the AD(JR) Act is not confined to those cases where a duty to make a decision is imposed, although such decisions are also picked up. In its terms, s.3(1) relevantly provides that a "decision" means - "[A] decision ... made, proposed to be made, or required to be made, as the case may be (whether in the exercise of a discretion or not) ..." Secondly, in the present case, it is the refusal to give a direction that is relied upon (cf. Commissioner of State Revenue v Royal Insurance Australia Ltd (1994) 126 ALR 1, per Mason CJ at 20; per Brennan J at 25-6).

[34]

Thirdly, Brownsville should be distinguished for our purposes. The issue there very much depended upon a rather special statutory context. The application sought an order of review in respect of the alleged failure of the Commissioner to decide whether to issue an amended assessment. An order was sought directing the Commissioner to make a decision whether amended assessments should be made. It was contended for the taxpayer, unsuccessfully, that the statute imposed a duty upon the Commissioner to make an amended assessment. But there was no reliance placed, as there is here, upon the provisions of s.3(2) of the AD(JR) Act, which, as has been noted, pick up, inter alia, a refusal to give a direction. Although I am of the view that there was here a relevant "decision", the question remains whether Right to Life was "aggrieved" by that "decision". In addressing this issue, it is to be borne in mind, as was noted in Cameron v Human Rights and Equal Opportunity Commission (1993) 119 ALR 279 (at 285) that this is - "... a mixed question of fact and law. It is well settled that the test is objective, not subjective: a 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." Whilst others may have been, in truth, aggrieved by the decision, and whilst Right to Life may have believed it was so aggrieved, in my opinion, objectively speaking, Right to Life should not, on the evidence before the Court, be regarded as a person aggrieved by the refusal of the Secretary to direct that the trials be stopped. Apart from its written constitution, there was no evidence of the nature or scale of the activities of Right to Life or of its membership. In its constitution, as has been noted, it is stated that the Association "shall be benevolent ..., charitable, non-denominational, non-party political with the [principal] ... objects [there mentioned]" (cl. 2). The constitution provides that "[a]pplication for membership of the Association shall be open to all persons who subscribe to the above objects" (cl. 5(a)). However, "[a]pplication for membership shall be approved or rejected at the complete discretion of the State Council ..." (cl. 5(b)). The management of the Association is vested in a State Council consisting of office bearers and eight other members of the Association elected at the Annual State Conference (cl. 6(a)). The principal objects of Right to Life suggest that, notwithstanding that the Association is "non-party political", it appears to be a body committed to "single issue politics", that issue being abortion. But, in my view, whilst in this area, questions of degree may be involved, it does not necessarily follow that the Association was, in truth, "aggrieved by" a decision under an enactment. This is so notwithstanding that the Secretary's determination that he would not act may have been perceived by the Association and others as an adverse "political" outcome if the matter is looked at from one angle of vision, that of a single issue political body. In my opinion, something more than this is required before it may be said that the party is actually aggrieved by the decision. It is true, as has been said, that questions of degree are involved here. In the Alcoa case (1981) 149 CLR 27, Gibbs J. pointed out (at 36) that the rule as to standing is "obviously a flexible one since ... the question what is a sufficient interest will vary according to the nature of the subject matter of the litigation". An example of a party which was held to have satisfied the statutory test may be found in the decision of Davies J. in the Australian Conservation Foundation case, supra, which was much relied upon in support of the appeal. But, in my view, it should be distinguished from the present case. There, the ACF sought judicial review of the decision of the Minister for Resources, made under regulations controlling the export of unprocessed wood, to grant an export licence in respect of wood chips to be obtained by logging areas of the South East forest which was part of the National Estate under the Australian Heritage Commission Act 1975. It was held that whilst the ACF did not have standing to challenge any decision which might affect the environment, it had standing here because the evidence established its special interest in the South East forests that were National Estate. Davies J. (at 73) distinguished the ACF decision of the High Court on the grounds (1) that the issue concerning land which was part of the National Estate was not a local issue such as may have been involved in the earlier ACF case; and (2) that in the decade that had passed since the ACF was denied standing to protect the wetlands at Farnbrough in Central Queensland, public perception of the need for the protection and conservation of the natural environment and for the need of bodies such as the ACF to act in the public interest had noticeably increased, as was demonstrated by the growth of the ACF itself since the time of the ACF case. His Honour noted that the evidence showed that the ACF was the major national conservation organisation in Australia and was established with a view, inter alia, to reconciling the use and exploitation of resources with the conservation of the natural environment. Davies J. said (at 73):

[36]

Davies J. referred (at 74) to evidence that ACF had played a leading role in the protection of the National Estate, Australia wide and in raising the debate on sustainable forestry in this country; that ACF had released a report entitled The Wood and the Trees - A Preliminary Economic Analysis of a Conservation-Oriented Forest Industry Strategy', a strategy which was being publicly debated as an alternative to the continued exploitation of the remaining old growth forests; and that ACF had also assisted in the publication of The Futures of Hardwood Plantations in New South Wales', a paper which considers the practical implementation of the ACF's natural forest strategy in the South East region. The ACF, both in its own name and in association with other environmental groups, had taken steps with governments and industry groups with a view to obtaining a proper strategy for the exploitation and conservation of the South East forests, including the protection of the Coolangubra and the Tantawangalo State forests because of their National Estate listing. His Honour went on to say (at 74): "While the ACF does not have standing to challenge any decision which might affect the environment, the evidence thus establishes that the ACF has a special interest in relation to the South East forests and certainly in those areas of the South East forests that are National Estate. The ACF is not just a busybody in this area. It was established and functions with governmental financial support to concern itself with such an issue. It is preeminently the body concerned with that issue. If the ACF does not have a special interest in the South East forests, there is no reason for its existence. In determining standing, it is necessary to take account of current community perceptions and values. As Stephen J said in the Onus case [at 42]: `Courts necessarily reflect community values and beliefs, according greater weight to, and perceiving a closer proximity to a plaintiff in the case of, some subject matters than others. The outcome of doing so, however rationalised, will, when no tangible proprietary or possessory rights are in question, tend to be determinative of whether or not such a special interest exists as will be found standing to sue.' In my opinion, the community at the present time expect that there will be a body such as the ACF to concern itself with this particular issue and expects the ACF to act in the public interest to put forward a conservation viewpoint as a counter to the viewpoint of economic exploitation."

[37]

Although Right to Life, in its stated objects, has asserted an interest in opposing abortion, there was no evidence adduced of activities of the scale or significance of the kind led in evidence by the ACF before Davies J.; nor of material of the type relied on by Sackville J. in North Coast Environment Council Incorporated v Minister for Resources, 16 December 1994, unreported, in which the present case was distinguished (at 49-50). Nor was there any evidence of a vocational or professional interest of the kind relied on to justify standing in Ogle v Strickland (1987) 71 ALR 41. There was no material before the Court here, for instance, to indicate that Right to Life had undertaken any particular research or study, or any other activity, in this area (cf. Central Queensland Speleological Society Incorporated v Central Queensland Cement Pty Ltd (No. 1) (1989) 2 Qd.R 512). In my view, Lindgren J. correctly held first, that Right to Life had not demonstrated that it was a `person aggrieved by the decision'; and secondly, that the proceedings should be dismissed as incompetent. Although his Honour went on to consider the third question, it did not, strictly speaking, arise for decision. Given the reluctance of civil courts to interfere in the criminal process (see, generally, Jarrett v Seymour (1993) 46 FCR 557 at 565-8; and specifically in the present area, see Attorney-General (Qld) (Ex rel Kerr) v T (1983) 46 ALR 275 at 277-8; Paton v British Pregnancy Advisory Service Trustees [1979] 1 QB 276; C. v S. [1988] 1 QB 135 at 152-3; Andrew Grubb and David Pearl, "Protecting the Life of the Unborn Child" (1987) 103 LQR 340 at 346; ALRC Report (No. 27) "Standing in Public Interest Litigation" at 29), it is preferable that no opinion be expressed on the third question. In any event, once it be held that Right to Life lacked standing, this question could not arise for determination. It follows that I would dismiss both the appeal and the cross-appeal. COSTS I agree with Lockhart J. I certify that this and the preceding thirty (30) pages are a true copy of the Reasons for Judgment herein of his Honour Justice Beaumont. Associate Dated: 10 February 1995

[40]

The proceeding at first instance was conducted on the footing that the application was for an order of review of a decision, within the meaning of sub-s. 5 (1) of the Administrative Decisions (Judicial Review) Act 1977 ("the ADJR Act"). No case was put relying upon "conduct" within the meaning of s. 6, or "failure to make a decision" for the purposes of s. 7. The "decision" in respect of which an order of review was sought was identified as that conveyed to the appellant in a letter dated 31 August 1994 from the officer acting in the position of the first respondent, being a decision not to stop 3 clinical trials of the drug Mifepristone. As Lockhart J. explains in his reasons for judgment, the activities involving the use of the drug took place in a statutory framework in which there were two sources of legislative regulation. The first is provided by the Customs Act 1901 and the Customs (Prohibited Imports) Regulations made thereunder ("the Customs Regulations"). The litigation has proceeded on the basis that permission under these regulations was given for the importation of the drug for use in the 3 clinical trials, subject to a condition that the use of the drug "be in compliance with Commonwealth, State and Territory legislation". There is no direct challenge to steps taken under this regulatory system. The case concerns the operation of the scheme established under the Therapeutic Goods Act 1989 ("the Act"). The object of that legislation, as appears from the statement in s. 4, is to provide "for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods ...". The Secretary, the first respondent and the cross-appellant, contends that the primary Judge was in error in deciding that the "decision" not to stop the 3 clinical trials was a "decision" within the meaning of sub-s. 5 (1) of the ADJR Act. The appellant submits that the primary Judge erred in deciding that it was not a "person aggrieved" by that decision. The two questions are interrelated and, in my view, an adequate conclusion as to the existence of standing may only be reached after an identification of the "decision" and a consideration of the enactment under which the decision was made. One difficulty with the present case is that the primary Judge, apparently at the invitation of the parties, approached these questions in reverse order. Sub-section 5 (1) of the ADJR Act operates in an ambulatory fashion over a wide area of federal law. Questions as to whether a particular applicant is "aggrieved" within the meaning of that provision arise in the context provided by the "enactment" under which the administrative "decision" in issue was made. The nature of the grievance and the justiciability of the complaint by the applicant concerning it, will appear first by identifying the decision giving rise to the grievance and then by considering the enactment under which it was made. The use by the Parliament of the term "aggrieved" is significant in several respects. First, it suggests that the question of standing is not answered simply by identification of a person who is an effective and faithful representative of the public interest in due administration of the law concerned. Secondly, it directs attention to what in federal administrative law are the constitutional limitations upon any statutory system which expands the concept of standing in a court exercising federal jurisdiction beyond the ambit of a "matter" (in Australia) or "case or controversy" (in the United States). See Australian Conservation Foundation Incorporated v The Commonwealth ("the ACF Case") (1980) 146 CLR 493 at 530, 539-40, 550-1, 554-5; Onus v Alcoa of Australia Limited (1981) 149 CLR 27 at 75. In the ACF Case (at 554), Murphy J. said that the concept of standing is closely tied to justiciability and to notions of judicial power. See as to the similar position in the United States, Schwartz "Administrative Law" 3rd ed., 1991, s8.12, 8.13. The Court has jurisdiction conferred when there is a "person aggrieved" by a "decision" which is "of an administrative character" and made "under an enactment". These matters are indicated by the terms of sub-s. 5 (1), when read with the definitions in s. 3. A "decision" includes a refusal to revoke an approval, consent or permission. The "enactment" must, to put it broadly, be a statute or instrument made thereunder. The reference in sub-s. 5 (1) to a person who is "aggrieved" includes (but, of course, is not limited to) a reference to one whose "interests are adversely affected" by the decision: para. 3 (4) (a). Hence the importance, in assessing whether the applicant is "aggrieved" and in ascertaining the content of the terms "interests", "affect" and "adversely", of the nature, scope and purpose of the particular enactment under which the decision has been made. In a sense, the position is analogous to that established by the precept that the ambit of an administrative discretion, otherwise unconfined, is to be determined with regard to the subject matter, scope and purpose of the statute by which it is conferred: The Queen v Australian Broadcasting Tribunal; Ex parte 2HD Proprietary Limited (1979) 144 CLR 45 at 49. In Alphapharm Pty Limited v Smithkline Beecham (Australia) Pty Limited (1994) 49 FCR 250 at 280, one reason for not treating the applicant as a person whose interests were affected, within the meaning of sub-s. 60 (2) of the Act by a decision to register, was that the object of the legislation was the timely availability of therapeutic goods after evaluation by an expert body pursuant to a complex and delicate administrative scheme; to treat a third party as "interested" in the decision to grant registration because that party was opposed to the grant, would disrupt that administrative scheme established by the statute. Put slightly differently, the purposes or ends which the Parliament sought to advance by enacting the statute were not those with which the applicant was concerned and seeking to advance by the processes of judicial review; see the discussion by Sackville J. in North Coast Environment Council Incorporated v Minister for Resources (16/12/94 unrep.). These considerations have heightened relevance when the enactment in question qualifies what otherwise would be an established common law right or freedom. In respect of administrative decisions made under such legislation caution is appropriate before treating as a person "aggrieved" one whose complaint is that the administrative decision denies or reduces any incursion into that right or freedom. That is to say, a decision which lifts rather than imposes or strengthens what otherwise is the statutory inroad upon the common law right or freedom, may not produce the relevant description of "grievance" to attract sub-s. 5 (1) of the ADJR Act. We were referred in the argument on the appeal in some detail to passages in Ogle v Strickland (1987) 13 FCR 306. However, for myself and in the light of what has been said above, I have some difficulty in deriving assistance for this appeal from those passages. My concern is as follows. First, one begins a process of statutory construction with the proposition that the common law proceeds upon what Lord Goff of Chieveley has described as "an assumption" of freedom of speech and expression, subject to exceptions provided in the civil and criminal law: Attorney-General v Observer Ltd [1990] 1 AC 109 at 283. Secondly, as a matter of statutory interpretation, the courts do not impute to the legislature an intention to interfere with such common law rights or freedoms in the absence of clear language: Bropho v State of Western Australia (1990) 171 CLR 1 at 17-18; Coco v The Queen (1994) 179 CLR 427 at 437. This consideration is distinct from what recently has been said as to the role of the Constitution in protecting freedom of communication, though obviously related to it: Theophanous v Herald and Weekly Times Ltd (1994) 68 ALJR 713 at 721-3. Thirdly, as Beaumont J. points out in his reasons for judgment in the present appeal, there is a reluctance on the part of the civil courts to interfere with or otherwise to pass upon, particularly on administrative review, matters relating to the criminal process. This especially is so where the administrative review is conducted under federal law and the criminal process is that of one or more of the States. In the present case, the primary Judge properly observed that possible breaches of the State criminal law are matters for the State prosecuting authority. (The only caveat which I would add is that the Constitution will require the State criminal law to yield to any immunity conferred by a federal law which covers the relevant field.)

[41]

In Ogle, the statutory scheme (described 13 FCR 306 at 315-6) was a serious inroad upon freedom of expression. (It may also be observed that s. 116 of the Constitution has been said to proclaim the principle of absence of religion as well as the principle of the toleration of all religions: Adelaide Company of Jehovah's Witnesses Incorporated v The Commonwealth (1943) 67 CLR 116 at 123 per Latham CJ). The statutory scheme provided for a system of film censorship which required a licence to import a film and a decision to approve its registration, without which the film was not to be delivered from the control of Customs. The Censorship Board was required not to register a film if, in the opinion of the Board, the film was "blasphemous, indecent or obscene". The Board had decided to grant a licence to import the film and to approve its registration. Thus the Board acted pursuant to the legislative scheme by lifting the prohibition otherwise imposed by the legislation upon freedom of expression in Australia. The appellants in Ogle sought to challenge those decisions. They asserted that, within the meaning of sub-s. 5 (1) of the ADJR Act, they were "aggrieved" by the lifting of the prohibition upon freedom of expression. In particular, they sought to draw the Court, upon administrative review, into the question of whether, as picked up by the legislation, the common law crime of blasphemy would apply upon the public exhibition of the film. The common law does not in this respect treat all religions indifferently. The crime is concerned with vilification only of the Christian religion: Regina v Chief Metropolitan Stipendiary Magistrate; Ex parte Choudhury [1991] 1 QB 429. It had been conceded at first instance, upon the hearing of the preliminary point as to standing, that the film was blasphemous (13 FCR at 316). Given the significance of the common law assumption of freedom of speech and expression, and the difficulty in dealing with matters of the criminal law in administrative review proceedings, to my mind there was a real question as to the treatment of those applicants as persons relevantly "aggrieved". The nature, scope and purpose of the legislative scheme being one which trenched upon a common law freedom, a legislative intention to treat as "aggrieved" a person who complained of the lifting of what otherwise would be a prohibition upon enjoyment of that freedom, would not readily be perceived. It would require unmistakable and unambiguous language, to use the phrase of Mason C.J., Brennan, Gaudron and McHugh JJ. in Coco, supra at 437. As I have said, the first task in the present case is to identify the decision under an enactment in respect of which the appellant was a "person aggrieved". It is unsatisfactory to deal with a claim to be a "person aggrieved" without first identifying the relevant decision. That step requires identification of the enactment under which it was made and an understanding of the enactment is necessary for a proper consideration of the issue of standing. I have referred to the object of the Act as set out in s. 4. The legislative scheme is to exempt certain goods from the requirements of Part 3 of the Act as to importation of therapeutic goods (s. 20). This is done by providing for an exempt classification by regulations made under sub-s. 18 (1). The exemption may be made "subject to such conditions (if any) as are specified in the regulations". It is an offence knowingly or recklessly to breach a condition of an exemption applicable under regulations made for the purposes of sub-s. 18 (1). Sub-section 22 (7) so states. It also is an offence for a sponsor of therapeutic goods knowingly or recklessly to supply them for use in Australia in humans, unless, inter alia, the goods are exempt goods (sub-s. 20 (1)). These provisions suggest that the terms in which the conditions are expressed are to be read even more closely than those of any condition which operates to terminate enjoyment of a right or immunity. Regulation 12 (1A) of the Therapeutic Goods Regulations ("the Regulations") is expressed as being made for the purposes of sub-s. 18 (1) of the Act. Its effect is that therapeutic goods used solely for experimental purposes in humans are exempt from the operation of Part 3 of the Act, "subject to compliance" with conditions (a) - (e). Conditions (a) and (b) require the sponsor to notify the Secretary of the intention to sponsor a clinical trial using specified goods, and to pay a fee. These steps must be taken before starting to use the therapeutic goods for experimental purposes in humans. Conditions (c) and (d) involve the monitoring and conduct of the trial by a committee constituted and operating as an ethics committee in accordance with guidelines issued by the National Health and Medical Research Council ("the NHMRC"). Conditions (c) and (d) are in the following terms: "(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."

[42]

If the sponsor or body conducting the trial receives advice from the ethics committee which is inconsistent with the continuation of the trial, then condition (f) operates. This brings to an end the exemption from the operation of Part 3 which was conferred by reg. 12 (1A), in conjunction with sub-s. 18 (1) of the Act. The primary Judge dealt in detail with the Statement on Human Experimentation and Supplementary Notes issued in 1992 by the NHMRC. He found that the ethics committees referred to in the Regulations are provided for in and operate under that Statement. His Honour said that the focus of the document was the ethical obligations owed by investigators and experimenters towards their human subjects, and found that questions of the sanctity of human life and of the unlawful administering of a drug within intent to procure the miscarriage of a woman were matters with which the ethics committees properly could concern themselves. I agree with those conclusions. The result is that the objective of the Act as stated in s. 4, the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods, is supplemented by the Regulations. Procedures for the timely availability of therapeutic goods after the conduct of clinical trials upon human subjects, involve the oversight of those trials by specialist committees which may properly concern themselves with ethical issues including questions of the sanctity of human life. The present litigation turns principally upon the remaining condition, condition (e). The primary Judge held that the decision which attracted the operation of sub-s. 5 (1) of the ADJR Act was made under condition (e) (ii). The text of condition (e) is as follows: "(e)the Secretary must not, at any time: (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."

[43]

Condition (e) may operate upon the exemption conferred by reg. 12 (1A) and sub-s. 18 (1), both as a condition precedent and a condition subsequent. It may operate before the conduct of the trial has commenced, with the result that the trial never takes place, or it may serve to bring to an end the trial whilst it is under way. The terms of condition (e) are not expressed so as to confer any power upon the Secretary to direct that the trial not be conducted or be stopped. The condition for the continuance of the exemption is that the Secretary has not given such a direction. However, I am prepared to construe the Regulations on the footing that a grant of power to give such a direction necessarily is implicit in condition (e); see Minister for Immigration and Ethnic Affairs v Mayer (1985) 157 CLR 290 at 302-3. However, what is implied is power to give the direction, if the Secretary has become aware that to conduct or to continue the trial would be contrary to the public interest. It follows that a decision to direct that a trial not be conducted or be stopped is made under the Regulations. Likewise, a refusal to make such a direction is, relevantly, a decision under that enactment for the purposes of sub-s. 5 (1) of the ADJR Act. It was submitted for the Secretary that sub-s. 5 (1) of the ADJR Act would be attracted only if the conferral of the power to give the direction carried with it a duty upon the Secretary. It was then submitted that in the case of condition (e) there was no such duty. In support of that submission as to the necessity for there to be a power coupled with a duty, particular reliance was placed upon Brownsville Nominees Pty Ltd v Federal Commissioner of Taxation (1988) 19 FCR 169. The submission, in essence, would limit the operation of s. 5 of the ADJR Act to decisions in respect of which there was a public duty, performance of which might be required by a writ of mandamus issued against an officer of the Commonwealth pursuant to s. 75 (v) of the Constitution. This would be contrary to the scheme of the legislation; see the discussion by Dr Allars "Standing: The Role and Evolution of the Test" (1991) 20 Fed L Rev 83 at 87-8. In sub-s. 3 (1) of the ADJR Act, the phrase "decision to which this Act applies" is defined as meaning a decision of an administrative character "made, proposed to be made, or required to be made ...". When dealing with this definition in Australian Broadcasting Tribunal v Bond (1990) 170 CLR 321 at 336, Mason C.J. used the phrase "a decision which a statute requires or authorizes ...". [Emphasis supplied] This is consistent with the general thrust of the ADJR Act to bring under the one system the various procedures otherwise existing for administrative review by subjecting them to the broad and unqualified terms in which the definition of "decision to which this Act applies" is expressed. It will be noted that in Brownsville at 172, the issue was described as being whether the decision was "of an administrative character required to be made under an enactment". That, in my view, was to misstate, by limitation, the operation of the definition in sub-s. 3 (1). I agree with what is said in the reasons for judgment of the other members of the Court as to the inadequacy of Brownsville as authority for the proposition that in the present case there could be no decision attracting the ADJR Act unless the Secretary was under a duty to act. However, that is not the end of the matter. It remains to consider the nature and scope of the power impliedly reposed in the Secretary by condition (e). The primary Judge held that where the Secretary has become aware that to conduct or continue the trial would be contrary to the public interest, then the Secretary is "by implication" empowered to direct that the trial not be conducted or be stopped. As I have indicated, I agree with that construction. His Honour later expressed the point: "Upon satisfaction of sub-paragraph (e) (i) of Item 3, sub-paragraph (e) (ii) authorises the making of a decision to direct or not to direct that the trials be stopped." I would prefer to identify the power of the Secretary as implicit in condition (e), taken as a whole and as a compound concept, and to describe the exercise of the power as contingent upon the Secretary first having become aware that to conduct or continue the trial would be contrary to the public interest. It is here that a crucial point on the cross-appeal arises. The cross-appellant points to and supports the finding of the primary Judge that what is required is "actual" awareness by the Secretary, that is to say a "subjective state of knowledge that to conduct or continue a trial would definitely be contrary to the public interest". (The consequences of bad faith on the part of the Secretary may be put to one side.) In reaching that conclusion as to the proper construction of condition (e), his Honour referred to the offence created by s. 20 of the Act. I have referred earlier in these reasons to the place of s. 20 (and s. 22) in the regulatory scheme created pursuant to the Act. The primary Judge said that criminal sanctions which support compliance with the regulatory scheme favoured a strict construction of condition (e). I agree. His Honour concluded that para. (i) of condition (e) is not satisfied by an awareness of something which "may render" either "the future as opposed to the current conduct of the trial" or "its immediate and future conduct", contrary to the public interest. This was important because the applicant had not submitted that the Secretary had actually become aware that to continue the trials definitely would be contrary to the public interest. Rather, the submission had been that the Secretary would become "aware" within the meaning of para. (i) if the Secretary had had no more than knowledge of circumstances which might render the present or future conduct of the trial contrary to the public interest. Upon the appeal, the appellant submitted that it would be contrary to the public interest, within the meaning of para. (i) of condition (e) for there to be continued use of the drug "in circumstances where a condition of [its] importation was not being observed". A term of the permission under the Customs Regulations had been, as I have indicated, that use of the drug "be in compliance with Commonwealth, State and Territory legislation". The appellant had contended that the trials "appeared" to involve persons in the "possible" commission of offences under s. 83 of the Crimes Act 1900 (N.S.W.) and s. 65 of the Crimes Act 1958 (Vic.). Having received submissions on this subject, the Acting Secretary informed the appellant that nothing had been raised which would warrant his acting to stop the trials and that, in particular, until presented with evidence to the contrary he must act on the belief that there was compliance with the laws of New South Wales and Victoria. He pointed out that certain abortions were legal in both States, and said that the appellant did not have the evidence on which to make an informed judgment on the matter. This provides the factual basis for the conclusion, of mixed fact and law, reached by the primary Judge that the Secretary had not actually become aware that to continue the trials definitely would be contrary to the public interest. That factual conclusion also means that there is no foundation for the submission of the appellant referred to above, namely that it would be contrary to the public interest within the meaning of condition (e) for there to be continued use of the drug because a condition of their importation, as to compliance with State laws, was not being observed. The further submission was made that it was the duty of the Secretary to pursue inquiries as to non-compliance where what was described as a "substantial and reasoned case" of non-compliance with the importation condition had been made. The submission was developed by saying that even if there had been no importation condition to that effect, it nevertheless was incumbent upon the Secretary in discharging the function to be performed under condition (e) to consider whether it would be contrary to the public interest to undertake or continue tests; involved in that consideration would be the question of whether the performance of the tests conflicted with "relevant State laws". These submissions fail for several reasons. First, the enforcement of the criminal law of the States is a matter for the relevant prosecuting authorities; in certain circumstances they may well decide not to prosecute, and for that decision the executive branch of government ultimately will be responsible to the legislature and to the electorate. Secondly, it is unlikely that the regulations, on their proper construction, and by a back-draft through condition (e), impose upon the Secretary any obligation or duty to inquire into compliance with and enforcement of the criminal law. Thirdly, the text of condition (e) requires the Secretary to have become aware that to undertake or continue the trial would be contrary to the public interest, not that the Secretary ought to have become so aware. It would be an odd construction which impliedly empowered the Secretary to direct that a trial be stopped, on the footing that, whilst the Secretary was not relevantly aware, inquiries ought to have been pursued and that had this happened the Secretary would have gained the necessary awareness to enliven the implied power to give a direction. One is returned to the fundamental point that without imputing to the Secretary an awareness which did not exist, it could not be said that the ground had been laid for the exercise of the power to direct that the trials be stopped. If the power was not exercisable at all, then the omission so to do could not, within the meaning of the ADJR Act, involve a refusal to make a decision. Otherwise, the ADJR Act would involve the Court in a process of review in which the complaint was that the decision maker failed to make a decision in exercise of a power which was, in truth, not open for exercise by the decision maker. As I have indicated, the primary Judge dealt with this issue in a manner largely consistent with that outlined above. His Honour pointed to the absence of any admission by the Secretary or proof of bad faith, and to his finding that the Secretary did not have the relevant actual awareness. One might have thought that this would then lead the primary Judge to the conclusion that there was no reviewable decision, and have answered accordingly question 2 of the questions for separate decision. However, the primary Judge continued: "Notwithstanding the matters to which I have just referred, question 2 must be approached on the hypothesis that on a final hearing it is established that the Secretary was so aware and was so entitled on 31 August 1994, and that the applicant is a 'person aggrieved' for the purpose of section 5 of the AD(JR) Act. Once this approach to question 2 is taken, that question becomes a narrow one and much of the difficulty touching it disappears."

[44]

What is said here is perhaps a consequence of the approach which had been taken in dealing with the questions for separate decision. Question 1, dealing with standing, was determined by his Honour in a judgment delivered 23 September 1994. Question 2, dealing with the existence of a reviewable decision, was dealt with in a judgment delivered 30 September 1994. It is my view, indicated earlier in these reasons, that the two issues were intertwined and could not be severed in this way, in particular by dealing with standing in advance of the identification of the reviewable decision in respect of which the appellant asserted that it was a person aggrieved. If there was no reviewable decision, then the issue of standing could not arise, other than as a hypothetical question. Had the matter been approached in this way, question 2 would have been answered adversely to the appellant rather than in its favour. It would then have been unnecessary to deal with question 1. The primary Judge also reserved for separate decision a third question. This was whether there was "under" condition (e) "a positive obligation" on the Secretary "to investigate possible breaches of State law". Although the primary Judge was understandably anxious that the Court, if possible, should pursue a course urged upon it as likely to resolve speedily and finally the matters in dispute, question 3 should not have been set aside in this way for separate decision. In the event, his Honour answered it in the negative. The issue to which question 3 goes is best seen as incidental to the issues of construction of condition (e) which arise in the course of determining question 2, that is to say the existence of a reviewable decision. I would allow the cross-appeal, and in place of the answer "Yes" set out in order (A) made 30 September 1994 insert "No". In place of the answer set out in order (B) made 30 September 1994 I would insert "Unnecessary to answer". Finally, as to order (A) made 23 September 1994, dealing with standing, I would delete the answer "No", and replace it by "Unnecessary to answer". Leave should be granted to the first respondent to file a notice of cross-appeal by 2 December 1994. To the extent necessary to deal as above with the orders made 23 and 30 September 1994, the cross-appeal and the appeal should be allowed. The first respondent should have an order against the appellant for the costs of the cross-appeal. On the appeal, the costs of the first and second respondents should be paid by the appellant. The substance of the matter is that the appellant has failed to overturn the order of the primary Judge that the application be dismissed. No order for costs of the proceeding at first instance has been made. It remains for the parties to relist the proceeding before the primary Judge for that purpose, if the matter cannot be resolved by consent order. I certify that this and the preceding twenty two (22) pages are a true copy of the reasons for judgment of the Honourable Mr Justice Gummow. Associate: Date: 10 February 1995.

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