Minister for Aboriginal Affairs v Peko-Wallsend Ltd

Newby v Moodie (1988) 83 ALR 523 R v Transport Regulation Board; Ex parte Maine Carrying Co Pty Ltd [1940] VLR 19 TOBACCO INSTITUTE OF AUSTRALIA v NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL No ACT G40 of 1996 FINN J CANBERRA 20 DECEMBER 1996

IN THE FEDERAL COURT OF AUSTRALIA) ) AUSTRALIAN CAPITAL TERRITORY ) ) No. ACT G40 of 1996 DISTRICT REGISTRY ) ) GENERAL DIVISION ) BETWEEN: TOBACCO INSTITUTE OF AUSTRALIA LIMITED (ACN 005 498 359) First Applicant PHILIP MORRIS (AUSTRALIA) LIMITED (ACN 004 316 901) Second Applicant ROTHMANS OF PALL MALL (AUSTRALIA) LIMITED (ACN 000 151 100) Third Applicant AND: NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL First Respondent ALISTAIR JACK WOODWARD, ANTHONY JOHN MCMICHAEL, ROBERT C CARTER, ALFRED JAMES MARTIN, SIMON FENTON CHAPMAN, ARTHUR WILLIAM MUSK, ANNETTE JANE DOBSON, CHRISTOPHER REYNOLDS, KONRAD DAVID JAMROZIK, RICHARD J TAYLOR, ALAN SEAWRIGHT, ELIZABETH CAIN, DORIS MARIA ZONTA, EDMUND HAU, NIGEL JOHN GRAY (THE MEMBERS OF THE NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL WORKING PARTY) Second Respondent CASHEL D'ARCY JAMES HOLMAN, DONALD NUTBEAM, ROSALEE VINEY, ROB DONOVAN, TERENCE MICHAEL NOLAN, BEVERLEY RAPHAEL, JUDITH DWYER, SOPHIE DWYER, RAE WALKER, CHRISTOPHER BERNARD DEL MAR, NIGEL JOHN GRAY (THE MEMBERS OF THE NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL HEALTH ADVANCEMENT STANDING COMMITTEE) Third Respondent

BRENDON JOHN KEARNEY, COLIN REX JOYNER, CASHEL D'ARCY JAMES HOLMAN, PAUL EDMOND O'BRIEN, JEAN PATRICIA COLLIE, CATHERINE LOUISE MEAD, DAVID JOHN RATHMAN, ALLAN CARMICHAEL, VERITY JANE COOPER, RICHARD GRAEME LARKINS, GAVIN MOONEY, BEVERLEY RAPHAEL, ROBERT JOHN SIMES, ANTHONY IRVINE ADAMS, DAVID KERRY KIRKE, SOPHIE DWYER, JOHN BELL, HILDA BASTIAN, CAROLINE ANNE CROWTHER, ROBIN WATTS (THE MEMBERS OF THE NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL NATIONAL HEALTH ADVISORY COMMITTEE) Fourth Respondent COURT: FINN J PLACE: CANBERRA DATE: 20 DECEMBER 1996 SHORT MINUTES OF ORDERS THE COURT ORDERS THAT:

1. The proceedings be stood over to a date to be fixed for the purpose of the making of orders, including orders as to costs.
2. The parties provide to the Associate of Justice Finn, by Friday 10 January, an agreed minute of the orders to be made (including the orders to be made as to costs) and if agreement has not by then been reached, the respective minutes of the orders for which they will respectively contend and brief outlines of the submissions made in favour of those respective forms. Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA) ) AUSTRALIAN CAPITAL TERRITORY ) ) No. ACT G40 of 1996 DISTRICT REGISTRY ) ) GENERAL DIVISION ) BETWEEN: TOBACCO INSTITUTE OF AUSTRALIA LIMITED (ACN 005 498 359) First Applicant PHILIP MORRIS (AUSTRALIA) LIMITED (ACN 004 316 901) Second Applicant ROTHMANS OF PALL MALL (AUSTRALIA) LIMITED (ACN 000 151 100) Third Applicant AND: NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL First Respondent ALISTAIR JACK WOODWARD, ANTHONY JOHN MCMICHAEL, ROBERT C CARTER, ALFRED JAMES MARTIN, SIMON FENTON CHAPMAN, ARTHUR WILLIAM MUSK, ANNETTE JANE DOBSON, CHRISTOPHER REYNOLDS, KONRAD DAVID JAMROZIK, RICHARD J TAYLOR, ALAN SEAWRIGHT, ELIZABETH CAIN, DORIS MARIA ZONTA, EDMUND HAU, NIGEL JOHN GRAY (THE MEMBERS OF THE NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL WORKING PARTY) Second Respondent CASHEL D'ARCY JAMES HOLMAN, DONALD NUTBEAM, ROSALEE VINEY, ROB DONOVAN, TERENCE MICHAEL NOLAN, BEVERLEY RAPHAEL, JUDITH DWYER, SOPHIE DWYER, RAE WALKER, CHRISTOPHER BERNARD DEL MAR, NIGEL JOHN GRAY (THE MEMBERS OF THE NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL HEALTH ADVANCEMENT STANDING COMMITTEE) Third Respondent

BRENDON JOHN KEARNEY, COLIN REX JOYNER, CASHEL D'ARCY JAMES HOLMAN, PAUL EDMOND O'BRIEN, JEAN PATRICIA COLLIE, CATHERINE LOUISE MEAD, DAVID JOHN RATHMAN, ALLAN CARMICHAEL, VERITY JANE COOPER, RICHARD GRAEME LARKINS, GAVIN MOONEY, BEVERLEY RAPHAEL, ROBERT JOHN SIMES, ANTHONY IRVINE ADAMS, DAVID KERRY KIRKE, SOPHIE DWYER, JOHN BELL, HILDA BASTIAN, CAROLINE ANNE CROWTHER, ROBIN WATTS (THE MEMBERS OF THE NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL NATIONAL HEALTH ADVISORY COMMITTEE) Fourth Respondent COURT: FINN J PLACE: CANBERRA DATE: 20 DECEMBER 1996 REASONS FOR JUDGMENT The issue I have had to decide in this proceeding does not relate to the persuasiveness or otherwise of the judgments made by the National Health and Medical Research Council (the "NH&MRC") in making the recommendations it has in its Draft Reporton Health Effects of Passive Smoking (the "Draft Report"). My concern is not with the science of the Draft Report nor with the public policy recommendations made. It is with the legality of the procedures adopted by, and of the decision making process of, the NH&MRC in this particular matter.

The first applicant, Tobacco Institute of Australia Ltd ("TIA"), is a creature of the tobacco industry. The second and third applicants, Philip Morris (Australia) Ltd and Rothmans of Pall Mall (Australia) Ltd, are presently the only members of the TIA. The applicants have not been separately represented in these proceedings. The NH&MRC, the first respondent, is a statutory corporation created by the National Health and Medical Research Council Act 1992 (Cth) ("the Act"). The functions of the NH&MRC and the procedures of present relevance imposed on it by the Act are set out separately below. The individuals who constitute the second respondents are the committee members of a working committee ("the Working Party") set up under s39 of the Act. They prepared the Draft Report of the NH&MRC. The persons who make up the third and fourth respondents are members, respectively, of another working committee and of a principal committee (see s35) of the NH&MRC. The present Amended Application challenges the conduct (both past and anticipated) of the four respondents in developing and preparing guidelines and/or regulatory recommendations concerning the health effects of passive smoking. I will enlarge on the detail of this below. Here I need merely indicate that that challenge is by way of an order of review under (a) s6 of the Administrative Decisions (Judicial Review) Act 1977 (Cth) (the "ADJR Act"); (b) s39B of the Judiciary Act 1903 (Cth); (c) the accrued jurisdiction of this Court; and (d) s4(2) of the Jurisdiction of Courts (Cross-Vesting) Act 1987 (Cth). The respondents initially objected to the competency of this Court to entertain this application. They now accept that the amendment to the application adding the cross-vesting legislation as a source of my jurisdiction has eliminated any ground of jurisdictional objection to my entertaining this matter: see Kelson v Forward (1995) 60 FCR 39 at 60. The NH&MRC: Its Act, Functions and Statutory Procedures Until the NH&MRC was placed on a statutory footing with the coming into force of its Act in June 1993, it was no more than a creature of Orders in Council made from time to time since 1936. I mention this for the purposes of noting that the change to a statutory regime occurred after the "old" NH&MRC had set up a working party to consider "the effects of passive smoking on health", and had advertised for public submissions. In 1986 the Council had produced a report on passive smoking and the working party was expected to update that report. In the event the pre-Act working party and its functions became subsumed in the post-Act Working Party with whose endeavours this application is in part concerned. It may well be that this metamorphosis of the old working party, coupled with the Council's unfamiliarity with operating under a statutory regime, affords some explanation of some of the conduct of the first and second respondents of which complaint has, or for that matter seemingly could have, been made. The object of the Act creating the NH&MRC is prescribed in s3. That section provides: "3. (1) The object of this Act is to make provision for a national body to pursue activities designed: (a) to raise the standard of individual and public health throughout Australia; and (b) to foster the development of consistent health standards between the various States and Territories; and (c) to foster medical research and training and public health research and training throughout Australia; and (d) to foster consideration of ethical issues relating to health.

(2) It is the intention of the Parliament that, to the extent that it is practicable to do so, the Council should adopt a policy of public consultation in relation to individual and public health matters being considered by it from time to time." I draw particular attention to sub-section (2). The process of public consultation, and the efficacy of it in this instance, loom large in this proceeding. The NH&MRC itself is created by s6 of the Act and, by s20, is given a large and diverse composition by no means confined to practitioners of health and medical research. Its functions, insofar as presently relevant, are set out in s7(1) of the Act. These are: "(a)to inquire into, issue guidelines on, and advise the community on, matters relating to: (i) the improvement of health; and (ii)the prevention, diagnosis and treatment of disease; and (iii)the provision of health care; and (iv)public health research and medical research; and (v) ethical issues relating to health; and (b) to advise, and make recommendations to, the Commonwealth, the States and Territories on the matters referred to in paragraph (a); ..."

As will be indicated, the passive smoking inquiry (if I can so call it) engaged in by the Council in the present case was leading towards the making of guidelines and/or of regulatory recommendations. I would note that the Act s4 defines a "regulatory recommendation" to mean: "a recommendation of the Council that is intended to be given legal effect in a State by legislation of that State." Importantly for present purposes, Part 3 Division 2 of the Act deals with the subject of public consultation. Section 12 - on which much of this application turns - provides as follows: "Consultation by Council 12. (1) Subject to sections 13 and 14, before the Council: (a) makes a regulatory recommendation; or (b) issues guidelines; or (c) engages in any other prescribed activity; the Council must consult persons or bodies in accordance with the steps set out in this section. (2) As soon as practicable after deciding that, subject to consultation processes, it intends to make a regulatory recommendation, issue guidelines or engage in a prescribed activity, the Council must publish a notice, in the manner and form specified in the regulations:

(a) informing of its intention to make the recommendation, issue the guidelines or engage in the activity; and (b) inviting persons or bodies to make submissions relating to the proposed recommendation, guidelines or activity in accordance with the procedures, and within the period, specified in the notice. (3) As soon as practicable after the end of the period specified under paragraph (2)(b), the Council must, having regard to any submissions received: (a) prepare a draft of the regulatory recommendation or guidelines that the Council proposes to make or issue or an outline of the prescribed activity in which the council proposes to engage and publish a notice, in the manner and form specified in the regulations: (i) containing the draft or outline; and (ii)inviting persons or bodies to make submissions relating to the draft or outline in accordance with the procedures, and within the period, specified in the notice; or (b) publish, in the manner and form specified in the regulations, a notice informing that it no longer intends to make the recommendation, issue the guidelines or engage in the prescribed activity." It will be necessary to analyse this section in no little detail. Of the remaining sections of Division 2 - sections 13 and 14 have no present relevance - it is only necessary to indicate that s15 provides:

"15.The council must develop and publish procedures to assist persons or bodies to make submissions under this Division." I will refer to the published procedures followed in this case when I consider specifically the consultative processes adopted in this matter. Little more need be said of the statutory scheme other than to note that the Act itself both creates, and allows for the enlargement of, a committee structure and that the second, third and fourth respondents are part thereof, with the second reporting (apparently) to the third and fourth. A Chronology of Events In 1986, as I have already noted, the NH&MRC published its report entitled Effects of Passive Smoking on Health. On 22 May 1993 it published a notice in The Weekend Australian (i) announcing it had established a working party to update that report; (ii) inviting public comment and consultation in this; and (iii) stating that further consultation would be undertaken once a draft report had been prepared.

By letter of 25 May 1993 the NH&MRC advised the TIA of this development, provided it with the proposed terms of reference and membership of the working party, and invited its comment on the issue of passive smoking. The terms of reference, to which the TIA was to object, were: "1. To review the epidemiological evidence linking passive smoking with disease in adults and children. 2. To assess the burden of illness due to passive smoking in Australia. 3. To make recommendations to reduce the burden of illness." These were to go through several iterations. Amended terms of reference were supplied to the TIA by letter on 29 September of 1993. That letter solicited a written submission from the TIA. It concluded: "The Working Party will not be able to meet with members of the Tobacco Institute of Australia but would be happy to receive any references or papers as you have suggested in your letter [of 22 June]." I would note for completeness that the letter referred to provided the NH&MRC with papers and with references to seventy-nine scientific publications and indicated that: "There are likely to be further papers which we would ask the Working Party to take into account and we would hope to submit references to such papers to you in the near future."

The then Terms of Reference remaining a source of dissatisfaction to the TIA - both on grounds of uncertainty and of coverage of relevant material - proceedings were commenced in the Federal Court on 21 January 1994 seeking relief under the ADJR Act in respect (inter alia) of the NH&MRC's conduct in relation to the then Terms of Reference and their coverage. I would note that another matter complained of in the TIA's Federal Court application was the NH&MRC's alleged refusal to apply to the working party's review the consultative procedures prescribed by s12 of the Act. On 9 March 1994 the NH&MRC published a notice under s12(2) inviting public submissions. This notice would appear to be a public acknowledgment that the NH&MRC was now conducting its deliberations in accordance with the provisions of the Act. I should add that the Act came into effect on 24 June 1993. The notice indicated that: "Through this consultation process, comments are being sought on the 1986 report (which is being updated) as well as the need for the NHMRC to issue guidelines and/or regulatory recommendations. The following areas are being considered for the development of guidelines and/or recommendations: workplace, public places and the home. This consultation process is in addition to an advertisement that was placed in the Australian on 22 May 1993, all comments received in response to this earlier advertisement will be also considered as part of the review." The TIA's litigation with the NH&MRC was settled on 18 March 1994. As part of that settlement the Secretary of the NH&MRC wrote to the TIA on 17 March confirming that the terms of reference of the Working Party were now: "1. To review the relevant scientific evidence linking passive smoking to disease in adults and children. 2. To estimate the extent and impact of any illness found likely to be due to passive smoking in Australia. 3. To make recommendations to reduce any illness found likely to be due to passive smoking in Australia." The letter went on: "The NH&MRC process is one of wide consultation with all interested parties. It is therefore inappropriate for the NH&MRC to direct its working parties to consider evidence brought forward by any person with a particular interest. However, the working party will consider in the review all relevant scientific evidence, including all relevant scientific evidence submitted to it by the Institute and by other interested parties." [Emphasis added] On 12 April the TIA made its submission to the Working Party - although I should add that two submissions were made by it (on 22 June 1993 and 29 June 1993) to the "old" working party. The submission was a thirty-four page document. Attached to it, as noted in the accompanying letter to the NH&MRC, were: "1. A report by J H Campbell BSc. PhD, Director, Centre for Research in Vascular Biology, Department of Anatomical Science, The University of Queensland; 2. Three folders containing those papers referred to in TIA's submission, plus four hard copy books; 3. Five individually bound volumes containing copies of comments of independent scientists in relation to the US EPA's report on the "Health Effects of Passive Smoking: Assessment of Lung Cancer in Adults and Respiratory Disorders in Children" dated 1 October 1990; 4. A bound volume containing comments by independent scientists entitled "Environmental Tobacco Smoke: A Guide to Workplace Smoking Policies - Public Review Draft" dated 1 October 1990; and 5. A folder containing comments on the EPA document entitled "Respiratory Health Effects of Passive Smoking: Lung Cancer and other Disorders" dated 1992." I mention these attachments as they are of no little significance in these proceedings. I refer, in particular to item 2 of the attachments which contained 122 scientific publications. These are referred to in the first paragraph of the submission in the following way: "In this submission the Tobacco Institute of Australia Limited ("TIA") calls upon the Working Party to have regard to a selection of scientific papers specifically brought to its attention by TIA. These papers contain data and opinions relevant to a thorough review of the issues under consideration. Copies accompany this submission in accordance with the request made by Dr Zonta [the Acting Secretary of one of the Working Party's parent committees and a co-opted member of the Working Party]." To back track slightly, in March of 1994 the TIA commissioned and funded what was described as the Independent Working Group (the "IWG") - a group of doctors and scientists chaired by a Dr J Lee - to examine whether a link exists between passive smoking and disease in adults and children and to prepare an evaluation of the scientific literature on the subject for the purpose of submission to the NH&MRC. That report was so submitted in November 1994. I should note that the NH&MRC's closing date for submissions was 11 April 1994. On 22 November 1995 the NH&MRC released the Draft Report to the public and supplied a copy to the TIA. Insofar as I can glean from the material before me the NH&MRC "discussed the draft report" (Report of the 120th session, p19, November 1995) sometime during its 120th session which was held on 22-23 November 1995. In the absence of any evidence to the contrary, I infer that the recommendations proposed in the Draft Report (at p210ff) were adopted by the NH&MRC in consequence of the reasoning of the Draft Report.

On 2 December 1995, by advertisement published in The Weekend Australian, the NH&MRC gave notice under s12(3) of the Act inviting submissions on the draft recommendations of the Draft Report. In so doing it initiated the second phase of public consultation mandated by the Act. I should conclude with one comment in passing on the Draft Report itself. While s12 of the Act envisages the publication of draft recommendations/guidelines, it does not as such require the preparation of a supporting document such as the present Draft Report. While this document clearly betrays the reasoning that underpins the NH&MRC's recommendations, that body was under no statutory duty to produce it. Nonetheless, in this proceeding it is entirely appropriate to have regard to it for the light it can throw upon the decision making processes of the Working Party. The TIA's Application The Working Party, whose actions for present purposes can be taken to be those of the NH&MRC, are alleged to have taken three steps which, individually, provide a variety of grounds of judicial review of the NH&MRC's conduct in developing and in continuing to develop the guidelines and/or regulatory recommendations contained in the Draft Report. Those three steps were as follows. Step 1. The relevant scientific evidence the NH&MRC considered in reviewing the association of passive smoking and disease consisted - "only [of] papers published in the peer-reviewed scientific press. In order to maintain a consistent quality of data, reports from symposia, conference abstracts and other papers that were not peer-reviewed were not considered": Draft Report, p 3. By way of explanation I should provide at this point Sir Gustav Nossal's description in his affidavit of what is signified by the terminology of "peer review". That description suffices for present purposes. "To describe a scientific or medical article as having been 'peer-reviewed' means that the article, prior to being accepted for publication, has been submitted to at least one but more usually two, three or more independent reviewers through a standard editorial process. These reviewers judge the appropriateness of the design of the study, the methods used, the results obtained and the conclusions reached. Only if they reach the view that a valid addition to knowledge has been made do they recommend publication to the editor of the journal.

In my experience, all the leading scientific journals require an article to be peer reviewed before publication." The "peer reviewed" only step referred to above resulted, the TIA alleges, in the exclusion from consideration by the NH&MRC of a considerable body of "relevant scientific evidence" submitted to it. And that exclusion caused the NH&MRC: (a) to act inconsistently with the mandatory provisions of s12 of the Act; (b) to fail to take account (or genuine account) of relevant considerations; (c) to fail to accord procedural fairness to the TIA, given the Terms of Reference of the Working Party and the undertaking to the TIA contained in the litigation settlement letter of 17 March; and (d) to act so unreasonably in preparing and publishing the Draft Report that no reasonable body could so act. Step 2. In considering the health effects of workplace exposure to environmental tobacco smoke ("ETS"), the NH&MRC acted upon the assumption that:

" ... risks due to ETS that apply in the home are likely to apply elsewhere, in proportion to the exposures received": Draft Report, p6. This process of "extrapolation" again resulted, so the TIA alleges, in the exclusion from consideration by the NH&MRC of a body of "relevant scientific evidence" (including peer reviewed evidence) on the health effects of workplace exposure to ETS. That exclusion gave rise to like grounds of complaint to those noted in 1 above. I should, perhaps, note that the vice in the NH&MRC's conduct given particular emphasis here was that of Wednesbury unreasonableness. Step 3. The NH&MRC failed properly to consider the submissions and supporting materials made to it by, or at the request of, the TIA. This allegation, which is based on factual inferences which I am asked to make, is again said to produce the same four grounds of complaint noted above. Of the three steps noted, only the third will be considered in any detail. However, I will comment briefly on aspects of the preceding two. Before considering any of these steps though I should refer to one preliminary matter.

The NH&MRC's Evidence Apart from calling Sir Gustav Nossal to give expert evidence on the methodology of the Draft Report, the NH&MRC has, for its evidence, relied all but exclusively on the Draft Report itself. No member of the NH&MRC, of the Working Party, or of the latter's secretariat was called. The applicants, in consequence, have made the predictable, but entirely appropriate, submission that I should not shrink from drawing Jones v Dunkell inferences favourable to them where these are available from the evidence: Jones v Dunkell (1959) 101 CLR 298. It is not open to doubt that Jones v Dunkell can be applied in applications for judicial review: see Minister for Aboriginal and Torres Strait Islander Affairs of the Commonwealth of Australia v Douglas, (unreported 28 May 1996 FC FCA,) and the cases referred to therein. The course pressed upon me is one taken in these reasons. The NH&MRC and Public Consultation As I have come to the conclusion that the NH&MRC failed to discharge its s12(3) statutory duty to have regard to the submissions made to it (via its Working Party), it is necessary to elaborate in a little detail upon how the NH&MRC put into effect the process of public consultation imposed on it by Part 3, Division 2 of the Act. I have already indicated that the NH&MRC only was placed on a statutory footing in 1993 and that for over half a century before this it existed under Orders in Council. As the second reading speeches on the bill which resulted in the Act make plain, two central considerations in this change of status were to ensure (i) that the NH&MRC had a guaranteed independence in which the community could have confidence; and (ii) again for reasons of community confidence, that the NH&MRC would: "operate in a public and open manner and be accountable for its actions." Parliamentary Debates, Representatives Vol H of R 184; 20 May-25 June 1992 at 3988. The process of public consultation which is enjoined by s3(2) of the Act, and which is made mandatory by Part 3, Division 2 when certain functions are being discharged (of which the present is one) is, seemingly, a by-product of consideration (ii) noted above. That process, as the Minister acknowledged in his second reading speech, had its genesis in advice given to him by the Administrative Review Council which is set out in full in that Council's Fifteenth Annual Report, 1990-91 (see esp. paras 38 ff; 64 ff). I mention these matters of legislative history, not because resort to extrinsic material is necessary to confirm or determine the meaning of any of the provisions of Part 3, Division 2, but rather to emphasise that public consultation is no peripheral part of, no afterthought in the scheme of, the Act. The courts have indicated in a variety of other contexts that "[c]onsultation is no empty term": TVW Enterprises Ltd v Duffy (No 2) (1985) 7 FCR 172 at 178; and that "[t]he requirement of consultation is never to be treated perfunctorily or as a mere formality": Port Louis Corporation v Attorney-General of Mauritius [1965] AC 1111 at 1124. Such observations can be applied with added force to the NH&MRC. The Act in its Part 3, Division 2 public consultation designedly places the NH&MRC in a partnership of sorts - albeit not an equal one - with the community it serves. There are obvious democratic reasons why the Parliament, in giving the NH&MRC its powers, subjected it to this obligation.

Turning now to the process of consultation that the NH&MRC was obliged by s12 of the Act to follow, the statutory scheme envisages a staged progression towards the making of a regulatory recommendation or the issuing of guidelines. The various stages need to be considered in turn. Stage (i) The triggering event for public consultation under Division 2 is a decision of the NH&MRC that, "subject to consultation processes, it intends [inter alia] to make a regulatory recommendation, [or] issue guidelines ...": s12(2). I have in this case been asked to infer that such a decision was taken, primarily from the publication in March 1994 of the notice inviting public submissions - a notice which, the sceptic might think, owed its existence to the litigation initiated against the NH&MRC by the TIA on 21 January 1994. I have referred already to the matters complained of in that litigation. The applicants' have not in these proceedings taken issue with whether the NH&MRC ever took the decision which triggered the s12 consultative process. In these circumstances I am prepared to draw the inference asked. I would have to say, though, that more direct illumination of what NH&MRC decided could properly have been expected from it. But this is not the only instance in which I have been asked to see through a glass darkly when considering the NH&MRC's actions and its compliance with its legislation. Stage (ii) As soon as practicable after its stage (i) decision the NH&MRC must publish a notice in the form prescribed (see Regulation 3) informing of its intention to make the recommendation/issue the guidelines and inviting public submissions "relating to the proposed recommendation [or] guidelines" in accordance with the procedures, etc in the notice. The procedures specified in the notice are those the NH&MRC is obliged to develop under s15 of the Act. It is unnecessary here to venture upon the question whether s12(2) contemplates a "proposed recommendation" having a degree of specificity distinctly lacking in the present case. The applicants have taken no objection on this score. Nor did they object to the notice as such. They did, as I noted earlier, take objection to the original terms of reference of the Working Party. The terms finally settled as a result of the 1994 litigation have been set out earlier. It will be necessary to return to them later in these reasons. The closing date for submissions was 11 April 1994. By the time the receipt of submissions ceased - and I have no precise evidence as to when this occurred although the Working Party did receive a submission as late as November 1994 - fifty four submissions had come in. These include ones made in response to the 1993 advertisement of the "old" working party. Stage (iii) As soon as practicable after the end of the period for submissions, the NH&MRC is required, having regard to any submissions received, to prepare a draft of the regulatory recommendation or guidelines it proposes to make or issue. In the present instance, the Working Party's recommendations contained in the Draft Report, pp210 ff were adopted by the NH&MRC as the draft regulatory recommendations/guidelines it proposed to make/issue.

I should add that I have not been made privy to the processes whereby the NH&MRC entrusted its function under s12(3) of the Act to the Working Party. I have been asked to assume that the power to delegate contained in s82 of the Act would meet any issue that might be raised as to this. At its 120th session the Council "discussed" the Working Party's Draft Report and "noted that it would now be released for public consultation": Report of the 120th session, p19. Before turning to that new (or second) round of public consultation, I should note that, because of the manner in which the Working Party and the NH&MRC have acted and interacted in this stage, it has been assumed before me that any vice in the Working Party's preparation of the Draft Report and in its recommendations would have infected the Council's own adoption of the draft recommendations. I would further add that it was the conduct of the Working Party in this stage that provided the genesis of these proceedings. Suffice it to say for present purposes, that insofar as complaint is made of failure to comply with the statutorily prescribed consultative process, it is that the Working Party did not have regard to the submissions received when preparing its recommendations. Stages (iv) and (v) The first of these involves yet another invitation to the public to make submissions to the NH&MRC - this time in relation to the draft regulatory recommendation/guidelines. Again a notice procedure, etc is statutorily prescribed: see also Regulation 3 of the Act. Stage (v), which is not referred to in the Act, is apparently the ultimate decision of the NH&MRC on its draft recommendation/guidelines after regard had to the public submissions received. As these two stages are only of relevance to the issue of appropriate relief in this case it is unnecessary here to comment further upon them. Did the NH&MRC Comply with its Statutory Duty under s12(3) to Prepare its Draft Recommendations "Having Regard to any Submissions Received"? The Draft Report, p3 indicates that all submissions received:

"were reviewed by senior project staff working on the review, summarised and key-worded, and summaries were circulated to all members of the Working Party. Copies of the full submissions were held on file and referred to as necessary in preparation of the report." In Appendix 1 to the Draft Report ("Process of Consultation and Summary of Submissions") these rather delphic observations were enlarged upon. As to the process of summary and distribution the Appendix says: "Submissions were received by the NHMRC secretariat in the Commonwealth Department of Health, and then read and summarised by research staff attached to the project in the Department of Community Medicine at the University of Adelaide. In addition, key words were assigned to each submission, to provide ready identification of the scope of each. A summary of each submission was then circulated to all members of the Working Party. Members of the Working Party requested the full text of selected submissions for further consideration. The submissions were then discussed at meetings of the Working Party. The full text of the submissions was referred to as necessary in the preparation of the preceding chapters." There were, as I have indicated, fifty-four submissions received. Amongst the documents tendered by the applicants are examples of the "summaries". These are at most one page documents (usually far less in those given me) and consisting in the main of one line dot-point propositions/statements. Narrative is sparse indeed.

The Appendix goes on (i) to set out the key-words used in the summaries; (ii) to provide a global account of the "content" of the submissions in just over one page; and (iii) to identify the persons who made submissions. It is the applicants' submission that the Working Party failed to comply with the obligation imposed by s12(3) to have regard to submissions received and by so doing invalidated the draft recommendations made by the NH&MRC. As put in their written submissions, their complaint is that in preparing the Draft Report, the respondents: "did not consider or, alternatively, did not genuinely consider, submissions and other material provided in support of those submissions by, or at the request of, the Applicants. So much may be inferred from the following circumstances: (i) the Draft Report's failure to address and/or adequately address many matters raised in those submissions, which matters were fundamental to the Respondents' exercise, such as: ·. misclassification bias; ·. publication bias; and ·. workplace studies; (ii) the totally inadequate nature of the summaries prepared by the Respondents' secretariats; and (iii) the Draft Report's failure to acknowledge, leave alone address, the vast majority of the studies and other supporting material which accompanied the submissions made by or at the request of the Applicants." Before turning directly to the evidence relied upon to support these inferences (for there are two available to be drawn) I should, first, outline the respondents' submissions and, secondly, refer to the import of the words "having regard to" in s12(3) of the Act.

1. The respondents' submission As I understood the respondents' submissions they proceeded in two steps. The first was that it was open on the evidence before me to infer that, as a matter of substance, the members of the Working Party were aware of the contents of the submissions received (it was accepted that the summaries alone were not sufficient for this purpose). Secondly, though having this awareness, they were not obliged to give any weight whatever to the contents of a submission, and for this reason they were entitled to decide not to take certain sorts of content into account as, for example, non-peer reviewed scientific literature, or workplace data on ETS.
2. "Having regard to" It is the case that the usual context in which courts in this country have construed the formula "have regard to" is one where, as part of a decision making process, regard is to be had to particular considerations or matters that are themselves of a substantive kind, eg particular criteria, effects, etc: see eg Australian Capital Television Pty Ltd v Minister for Transport and Communications (1989) 86 ALR 119. In cases of that variety, the "have regard to" formula has been interpreted consistently as requiring that the decision maker subject to the formula must "take into account" the matter or consideration to which regard is to be had, and must "give weight to" that matter or consideration "as a fundamental element in making his determination": Re R J D Hunt; Ex parte Sean Investments Pty Ltd (1979) 53 ALJR 552 at 554 per Mason J; see also R v Toohey; Ex parte Meneling Station Pty Ltd (1982) 158 CLR 327 at 333, 338; Queensland Medical Laboratory v Blewett (1988) 84 ALR 615 at 623. Distinctively, in the present case, s12(3) of the Act does not oblige the NH&MRC to have regard to a particular matter as a consideration relevant to the substance of its decision and of which account must be taken for that reason. Rather it must have regard to the submissions received irrespective of whether, in the end, they are found to contain matter relevant at all to the decision to be taken. This obligation is a central element in facilitating the community's participation in the NH&MRC's policy development process. Viewed in this light the import of the formula must be somewhat different from that indicated by Mason J in Sean Investments, above. Given the purpose to be served by the consultation process, I would adapt what Mason J said in Sean Investments so that the obligation to have regard to submissions received required the NH&MRC, in preparing the draft recommendation, to take them into account and to give positive consideration to their contents as a fundamental element in its decision making. By way of elaboration, "positive consideration" of a submission (i) would preclude the adoption of an a priori criterion which itself excluded a part or parts of that submission from actual consideration; and (ii) would involve "an active intellectual process directed at that ... submission": Tickner v Chapman (1995) 57 FCR 451 at 462 per Black CJ. It is clear that the NH&MRC (through the Working Party) has fallen well short of meeting this obligation both because of the internal procedures the Working Party adopted in dealing with submissions and because of the "self-denying ordinance" it imposed on itself in respect of the matters to which it would give consideration. First, the internal procedures. Though this was not a matter that loomed large in the applicants' submission (it was a part of it), the respondents have seemingly accepted that unless it can be inferred that the Working Party were aware of the contents of the submissions received, they do not begin to satisfy the s12(3) requirement. In my view, before it could properly be said that the Working Party considered the submissions, let alone considered them in the manner I have indicated, the members of the Working Party, at least collectively, should have been fully aware of the actual contents of all or virtually all submissions received. Whatever may have been appropriate for the Council of the NH&MRC when informing itself in this regard: cf Norvill v Chapman (1995) 133 ALR 226 at 240; Tickner v Chapman above; Minister for Aboriginal and Torres Strait Islander Affairs of the Commonwealth of Australia v Douglas, above; I am by no means satisfied that a 10+ member apparently appropriately qualifiedWorking Party constituted for the purpose of acting in the Council's stead, should not have been expected (collectively at least) to read all or virtually all of the submissions made. It may have been perfectly appropriate to have utilised the services of two researchers at the Department of Community Medicine at the University of Adelaide to prepare short summaries of, and key words for, submissions. It was quite another matter, in my view, for the Working Party members simply to decide individually which of the submissions they might like to read in light of the summaries received. The community was not invited to make submissions to two University researchers in Adelaide in the hope that a member of the Working Party might read their submissions. I have, of course, no evidence before me upon which a finding could properly be made that all or virtually all of the submissions were read by members of the Working Party. And it was open to the respondents to cast light on this matter. They have chosen not to. I have not been invited to decide, and I refrain from deciding, this matter on this bare ground. I am prepared to assume for present purposes that members of the Working Party could have been (though not necessarily were) sufficiently aware of the contents of all of the submissions notwithstanding that not all were actually read by one or more of them. Though not accepting they have the onus in this matter, the respondents have asked me to infer that awareness in fact from the aggregate effect: (a) of the summaries; (b) of the tabling of some submissions at a meeting or meetings; (c) of the distribution to all members of the entirety of the TIA's submission (but not the accompanying papers, etc) and of the report of the Independent Working Group chaired by Dr Lee; (d) of the just over one page global summary of the contents of submissions contained in the Draft Report; and (e) of the distribution to individual members of the Working Party of "about two thirds" of the 122 papers (but not the other materials) attached to the TIA's submission. The respondents accept that no one of these standing alone would suffice to warrant the inference of awareness they suggest should be drawn. For my own part, I do not consider the aggregate effect of the matters referred to significantly advances that position. I quite agree with the applicants' submission that, to the extent that the summaries bear the burden of conveying the import of the submissions, they are "totally inadequate". Equally the tabling of some submissions at a meeting warrants no inference that all or any were read in consequence. For the rest I am prepared to conclude that the Working Party was well and truly familiar with the contents of some number of the submissions made. But if it was necessary for me so to do, I would not be prepared to find by way of inference that they had that awareness of all (or virtually all) of the submissions or even of those made at the applicants' request. The reason I consider it unnecessary to decide this matter is that I do not consider the Working Party to have dealt with the submissions as required by s12(3): they have not been taken into account and positive consideration has not been given to their contents as a fundamental element in the Working Party's decision making. As I earlier indicated, the respondents have submitted that, because they are not obliged to give any weight whatever to the content of a submission, no member of the public could complain if the Working Party decided not to take certain sorts of content into account. The first of these propositions is undoubtedly correct: Minister for Aboriginal Affairs v Peko-Wallsend Ltd (1986) 162 CLR 24 at 40-41. The second, not so. The public submission process is designed to facilitate community participation in the NH&MRC's policy formulation. The community is not to be excluded from that participation simply because, for whatever reason, the NH&MRC does not wish to give consideration to some part of the contents of submissions properly and appropriately made to it. I have been provided by the applicants with several documents which are said to contain examples of matters in the submissions made by the TIA (or at its request) which have not been considered by the Working Party. It is unnecessary to refer explicitly to these examples. I should, though, comment that I do not regard failure to advert in the Draft Report to a particular matter raised in a submission as necessarily implying of itself that that matter has not been considered by the Working Party. Suffice it to say that the respondents acknowledge they generally took no account of non-peer reviewed material in submissions, or of published studies on exposure to ETS in the workplace. Nonetheless they invite me to conclude they were aware of that material and of those studies but simply gave no weight to them. While I would be reluctant in any event to reach that conclusion - it seems implausible to say the least - it simply does not indicate that positive consideration was in fact given to those parts of submissions containing material with which the Working Party did not wish to engage. The NH&MRC (through the Working Party) could not avoid this statutory responsibility even if in the end it decided to give some or all of that material no weight. I would have to say that the brief comments made at pages 3, 6 and 87 of the Draft Report confining the review conducted to peer reviewed materials and to ETS studies in the home to the exclusion of workplace studies, do not provide adequate evidence of positive consideration being given to those parts of the submissions which were, ultimately, given no weight. Rather they bespeak an unpreparedness to consider those parts. In the event I am prepared to conclude that the Working Party, hence the NH&MRC, failed to have regard to the submissions received in preparing the draft recommendations envisaged by s12(3). I am the more confident in arriving at this conclusion given that no member of the Working Party or of the Council chose to give evidence on the matter. Subject to what I have later to say on discretionary considerations, this conclusion is sufficient of itself to justify the grant of relief. However, because of the interconnectedness of the various grounds of complaint advanced against the actions of the Working Party and the NH&MRC, it is appropriate that I deal, albeit more briefly, with at least aspects of those other complaints. The NH&MRC Failed to Have Regard (Genuine Regard) to Relevant Considerations/Denied the TIA Procedural Fairness These two grounds of complaint are, in considerable degree, reformulations of that already considered. Each, in different ways is focussed upon the scope or ambit of the inquiry engaged in by the Working Party for the purpose of producing its recommendations. And in both instances one is concerned first with the status of the Terms of Reference finally approved by the NH&MRC for the Working Party and, then, with the capacity of the Working Party to make, without adverse legal consequences, such unilateral changes to those Terms of Reference as it, for whatever reason, was minded to make. For the present I will confine what I have to say to the relevant considerations ground. As I understand the applicants' submission, it is this. First, howsoever broad and seemingly indefinite in scope was the s12(2) intention of the NH&MRC to make a regulatory recommendation/issue guidelines, the Terms of Reference (finally settled for the Working Party after the 1994 Federal Court litigation) gave substance and direction to the subject matter both of the inquiry and of the consultation, to be undertaken by the NH&MRC through the Working Party. Secondly, while the Act itself did not prescribe what were the relevant considerations of which account should be taken by the NH&MRC when exercising its s12 statutory function, the NH&MRC itself defined (by reference to subject matter through the Terms of Reference) what some at least of those considerations were. Thirdly, though it was entirely appropriate for the NH&MRC so to prescribe the subject matter both of review - cf Sean Investments Pty Ltd v MacKellar (1981) 38 ALR 363, at 375 - and of consequential public submission, it was equally appropriate to review the decision making of the NH&MRC on the ground that it had unilaterally excluded from consideration (or from genuine consideration) material which it previously had determined to be relevant by virtue of the Terms of Reference it had approved. The respondents' submission - and I here incorporate matter advanced primarily in the procedural fairness submissions - was, first, that the generality of the s12(2) intention of the NH&MRC was not made more specific by the Terms of Reference which were purely an internal matter as between the Council and the Working Party. Secondly, the subject matter of inquiry (and of public consultation) was the health effects of passive smoking and it was open to the Working Party to determine the matters to which, and the material for which, it would have regard in making its recommendation. Thirdly, the decision both to limit its review of scientific evidence to peer reviewed material and to exclude studies on ETS in the workplace, were ones properly open to it as a matter of judgment and methodology: cf Sir Gustav Nossal's affidavit. Fourthly, in any event, the TIA knew from at least October 1994 that the NH&MRC did not intend to have regard to peer reviewed materials. I deal with, and reject, this last submission separately below. As I agree with the applicants' submissions in this I need only make a few additional comments. Whatever may have been the case if the Act had not cast a public consultation obligation on the NH&MRC, once the NH&MRC (through its s12(2) decision and the Terms of Reference it imposed on the Working Party) had determined the subject matter of inquiry and of public consultation, it thereby provided and fixed some part at least of the criteria for judging whether material was or was not relevant to the decision it had foreshadowed it intended to take. I emphasise "fixed" for this reason. The public is, in the Act's terms (s12(2)), invited to make submissions "relating to the proposed recommendation, [or] guidelines". The effect of the NH&MRC's providing the Terms of Reference to those members of the public who sought information as to making a submission was to give shape and direction to the consultative process to the extent that those Terms of Reference particularised the subjects of inquiry. It would, in my view, subvert the clear purpose of the Act in its requirement of public consultation if the NH&MRC could invite public participation on one stated basis and then to change that basis privately and unilaterally. By such action the NH&MRC could for practical purposes qualify or nullify its s12(3) obligation to have regard to the submissions received. A submission furnished on one basis might be rendered wholly or partially irrelevant to a decision which, because of the change made, was to be taken on another. By its decision to exclude both non-peer reviewed materials and studies of ETS in the workplace (whether or not peer reviewed), the Working Party excluded from consideration - or else from genuine consideration: Hindi v Minister for Immigration and Ethnic Affairs (1988) 20 FCR 1 at 12-13 - materials which, because of the Terms of Reference and of the scope of the proposed recommendation/guidelines, were properly placed before it by the TIA and others for consideration by it in its decision making. Whether or not weight should have been given to that material after consideration of it was altogether another matter. What was required was that it be subjected to consideration in a "real sense": Turner v Minister for Immigration and Ethnic Affairs (1981) 35 ALR 388 at 392. Such was not given.

In reaching this conclusion I should make plain that I am not passing judgment upon the appropriateness or otherwise of medical scientific researchers, as a matter of disciplinary practice, utilising peer review as a discriminator of publications within the discipline. As is well known, this practice is not uncommon in both the sciences and some social sciences. This said, it should be acknowledged that the language used in the Draft Report to justify the use of peer reviewed materials only was, as Sir Gustav Nossal was compelled to concede, "infelicitously phrased". What was objectionable in what the Working Party did was to adopt this exclusionary discriminator without bringing to the notice of the public that this was what they were going to do, the plain meaning of their Terms of Reference notwithstanding. They misled the public. I earlier noted that the NH&MRC has submitted that, from at least October of 1994, the TIA was aware of the decision to exclude non-peer reviewed material and that, for this reason, it should not be able to raise this now as a cause of complaint. I do not consider that the evidence substantiates this submission.

What the NH&MRC principally relied upon was a paragraph from a letter of the TIA to the NH&MRC of 27 December 1995 - a letter, I would note, that elsewhere objected to the methodology of the Draft Report in this very matter. The paragraph in question runs as follows: "Finally, I would like to raise one other matter. At page 117, the draft report refers to 2 unpublished theses by Liew and Sexton. In October 1994, when my predecessor asked your predecessor, Dr Zonta, for copies of these, she was told there would be no reference to them in the draft report, because they had not been peer-reviewed. The Institute, therefore, took no action in relation to the theses. Now that they have been included in the draft report, contrary to Dr Zonta's assurance and in spite of the Working Party's avowed policy of excluding non-peer-reviewed material, I require copies of the theses by return mail." Of this, I would merely say that while it provides explanation of why the two unpublished theses were not to be used, it cannot, in its reference to what occurred in October 1994 (as distinct from what was revealed in the Draft Report to which the letter earlier objected), reasonably be taken as supporting the inference that the exclusion policy was then announced to, and was so understood by, the TIA. I would add that the actual correspondence of 15 and 25 October 1994 (to which reference was made in evidence) serves only to confirm this view. It is unnecessary to set it out here. I would merely say that that correspondence had a quite particular focus. It would be unrealistic to treat references made in it to peer-review as having any significance other than in relation to the particular matters the subject of that correspondence. I have so far considered this matter from the standpoint of a failure to have regard (or genuine regard) to relevant considerations. I do not consider that, by looking at the matter as one of procedural fairness, one would be led down a different path of reasoning to a different conclusion. Here I need merely say that, given the manner in which the Working Party put the NH&MRC's consultative obligation into effect, the Working Party then acted unfairly towards those who made submissions relying on the terms of the published notice and the Terms of Reference. I do not consider it necessary to venture further into the question of procedural fairness and in particular into whether the NH&MRC, because of its 17 March letter to the TIA, assumed an obligation of procedural fairness to the TIA at common law over and above that owed the public at large.

Wednesbury Unreasonableness Given that I have already found against the NH&MRC on each of the grounds of complaint so far raised, it is unnecessary to express a concluded view on whether, in extrapolating from the health effects of ETS in the home to those in the workplace in particular, it was guilty of Wednesbury irrationality. I refrain from so doing. Discretionary Considerations and the Grant of Relief It is accepted by the parties that, because this application challenges the actual and apprehended conduct of the respondents, no express limitation period precludes the bringing of it: cf ADJR Act 1977 s11 in relation to challenges to a decision. Nonetheless, the respondents advance two bases for the denial of relief as a matter of discretion, notwithstanding that the applicants have made out grounds of review of their conduct. These are (1) that there was unreasonable delay in bringing this proceeding; and (2) that the applicants had previously elected not to seek an order of review.

Unreasonable Delay/Election While these two are distinct, it is appropriate to deal with them together because of their factual interaction. The delay submission was put this way. (i) It was open to the TIA to have challenged the NH&MRC's s12(3) decision (adopting the recommendations of the Draft Report) and such a challenge would have allowed it to ventilate the very same matters of substance raised in this proceeding. (ii)If the TIA had taken that course and under the ADJR Act, it would have been obliged to institute proceedings 28 days after 22 November 1995, the date on which it received a copy of the Draft Report: see ADJR Act, s11(3). (iii)The TIA did not commence proceedings until 4 July 1996 a delay of over 7 months. (iv)Because there was an available and appropriate avenue of complaint as from November 1995, the delay of the TIA should be measured from then and the 28 day limitation imposed by the ADJR Act should be seen as providing a significant indicator of what delay is unwarrantable. The election submission, for its part, was as follows. (i) The TIA took a deliberate decision to seek to reverse the effects of the draft recommendation by means other than judicial review - by means which were consistent with accepting the lawfulness of the draft recommendation. (ii)Those means involved the positive participation by the TIA in the s12(3) phase of public consultation on the draft recommendations. (iii)Through continued provision of material to the NH&MRC, seeking extensions of time in which to make a submission, and making a submission on the draft recommendations on 28 March 1996, the TIA had elected to dispute the merits of the recommendations not their lawfulness.

In relation to election, I would note that reliance was placed upon the decision of O'Bryan J in R v Transport Regulation Board; Ex parte Maine Carrying Co Pty Ltd [1940] VLR 19, esp at 34-35 and on decisions applying it. Reference was also made in relation to both submissions to Newby v Moodie (1988) 83 ALR 523. The applicants' response to these submissions is that virtually from the time of the Draft Report, it has challenged the NH&MRC's methodology and adherence to the Terms of Reference: see its letter to the NH&MRC of 27 December 1995. These were the very matters that were the substance of these proceedings and there was no basis from the time of that letter until the bringing of the present application to suggest that these objections had been abandoned or that the Draft Report was being accepted with only its merits being contested. Furthermore on the issue of methodology, the TIA attempted over time to have this discussed with the NH&MRC but received no adequate response at all from the NH&MRC. Then, with the prospect of litigation emerging in June 1996, it was the TIA which proposed mediation. I was taken at length through the correspondence between the TIA and the NH&MRC from December 1995 to July 1996. I consider that no real purpose would be served by setting it out here. The comment I would make of it is that it is eloquent of a consistency in the complaints made by the TIA concerning the Draft Report and of the TIA's desire to have these addressed by the NH&MRC. Those complaints were in substance the ones raised, and made out, in these proceedings. I would have to say I can find no basis in the material before me that reasonably would justify the conclusion that the applicants have made an election such as would preclude them from seeking the relief they have. Insofar as the issue of delay is concerned, I do not regard that which has occurred as so unreasonable in the circumstances as would justify a refusal of relief. It is important to note that this inquiry has extended over some number of years. Whether or not the two months deadline imposed by the NH&MRC for submissions on the draft recommendations was reasonable, is not for me to say. What I consider is clear is that the TIA wanted its particular complaints addressed. It was the lack of reassurance the ITA received in this that led ultimately to litigation. In the circumstances I do not believe that they have acted unreasonably or without appropriate expedition.

I should comment directly on the attempted analogical use of the ADJR Act as an indicator of unreasonable delay in the circumstances. It probably is the case, as the applicants concede, that they could have challenged the NH&MRC's s12(3) decision of November 1995 - in which case they would have had a 28 day limitation period imposed on them. What, though, needs to be recalled is that that decision was merely a stage in an ongoing, five stage process. In these circumstances it was not at all inappropriate for the applicants to view the matter as an evolutionary one and to respond to the manner in which the NH&MRC was conducting itself in the way in which they did. The ADJR Act analogy is one ill-suited to a process of the type envisaged by s12 of the Act. In the event, then, I do not consider that there are discretionary grounds for denying relief to the applicants. I have concluded that the NH&MRC has failed in discharging its statutory duty of public consultation; that it did not give genuine consideration to relevant material in the submissions made to it; and that it denied the applicants procedural fairness. Accordingly I will make orders that will have the effect of sanctioning the NH&MRC's failure in adhering to its obligations both under s12 of the Act and at common law. I will, though, invite submissions from the parties on the precise form of orders that should be made in light of these reasons. I certify that this and the preceding 51 pages are a true copy of the Reasons for Judgment herein of the Honourable Justice Finn. Associate Dated: 19 December 1996 Counsel for the applicant : B Walker SC, Dr J Griffiths Solicitors for the applicant: Clayton Utz Counsel for the respondent : L Katz SC, L Aitken Solicitors for the respondent : Australian Government Solicitor Date of hearing : 18, 19, 20 November 1996 Date of judgment : 20 December 1996