Eli Lilly Australia Pty Ltd and Minister for Health and Family Services [1999] AATA 78 (8 February 1999)

Last Updated: 4 February 2009

Administrative

Appeals

Tribunal

REASONS FOR DIRECTIONS [1999] AATA 78

ADMINISTRATIVE APPEALS TRIBUNAL )
) No N98/130
GENERAL ADMINISTRATIVE DIVISION )

Re ELI LILLY AUSTRALIA PTY LTD
Applicant

And THE MINISTER FOR HEALTH AND FAMILY SERVICES
Respondent

DIRECTIONS

Tribunal Mr BJ McMahon (Deputy President)

Date 8 February 1999

Place Sydney

Directions The Tribunal directs that documents 10 and 12 in Appendix 1 to the respondent’s Supplementary Statement of Facts and Contentions on section 60A issues be not considered by the Tribunal. All other documents referred to in that appendix may be considered at the substantive hearing. The applicant has liberty to apply in accordance with these reasons.
(Sgd) BJ McMahon
..............................................
Deputy President

REASONS FOR DIRECTIONS

1. The respondent applied for directions to consider the effect of section 60A of the Therapeutic Goods Act 1989, in relation to certain documents lodged with the Tribunal and intended to be used by the applicant at the substantive hearing.
2. Section 60A was inserted by s 82 of Act No. 6 of 1996, which came into effect on 11 June 1996. Its terms are as follows:

“60A New information on review - discretion to remit

(1) This section applies only if the Secretary or an authorised delegate makes a decision under section 25 in relation to therapeutic goods.
(2) If a person (the appellant) whose interests are affected by the decision requests the Minister to reconsider the decision, and lodges new information in support of that request, the Minister must either:

• (a) take that information into account when he or she reconsiders the decision; or
• (b) remit the matter to an authorised delegate for a fresh decision.

(3) If the appellant applies to the Administrative Appeals Tribunal for review of the decision on reconsideration, and lodges new information in support of that application, the Tribunal may, if the Tribunal thinks fit, remit the matter to an authorised delegate for a fresh decision.
(4) The Tribunal must not remit the matter under subsection (3) if all of the new information is information that the Minister took into account under paragraph (2)(a) in making the decision on reconsideration.
(5) If:

• (a) the appellant lodges new information in support of an application to the Administrative Appeals Tribunal for review of the decision on reconsideration; and
• (b) the Tribunal does not remit the matter under subsection (3);

the Tribunal, in reviewing the decision on reconsideration:

(a) may consider new information (if any) that the Minister took into account under paragraph (2)(a) in making the decision on reconsideration; and
(b) must not consider any other new information, except new information that indicates that the quality, safety or efficacy of the therapeutic goods is unacceptable.
(2) If:

• (a) the Minister or the Tribunal remits the matter; and
• (b) the appellant has paid, as a further evaluation fee, the evaluation fee that the appellant would have to pay under section 24 on making a new application for registration of the therapeutic goods;

the authorised delegate must make a decision under section 25, taking into account the new information, as if a fresh application for registration had been made.

(1) To remove any doubt, the authorised delegate’s fresh decision is to be treated, for the purposes of subsequent applications of section 60 and this section, as a decision under Part 3.
(2) In this section

authorised delegate means a delegate of the Secretary exercising a power to decide whether to register therapeutic goods.

new information means information that:

(a) was in existence at the time the decision referred to in subsection (1) was made; and
(b) was not made available to the Secretary or authorised delegate for the purpose of making the decision; and
(c) is relevant to that decision;

and includes any opinions that are wholly or substantially based on such information (whether or not the opinions were formed before or after the decision was made).”

3. The applicant’s product has been registered under s 25 for certain purposes or indications. Believing that research indicated that the product could be used for other purposes, the applicant made a further application on 6 September 1996, under s 25, for approval of an additional indication. A package of scientific data was submitted in support of the application.
4. An officer of the Department made a preliminary assessment and then referred the application to the Australian Drug Evaluation Committee (‘ADEC’). This is a statutory committee whose members have expertise in therapeutic drugs. It is established under regulation 36 of the Therapeutic Goods Regulations, which specify its functions to include the making of medical and scientific evaluations of any drugs that the Minister or Secretary refers to it for evaluation.
5. ADEC considered the application, the original accompanying material and some additional material which was submitted by the applicant pursuant to s 31, and dealt with the whole application at its meeting on 7 and 8 August 1997.
6. The committee resolved that the application should be approved, subject to the inclusion in the indication of certain more specific descriptions. It also recommended the inclusion of certain words in the product information and future approval of that information, which was to incorporate two further recommendations of ADEC. Those recommendations dealt with the stage in a patient’s development when treatment should be attempted and statements indicating the lack of experience with a constituent in certain classes of patients, although acknowledging that the need for the product’s use in patients of that kind had not been established.
7. The recommendation of ADEC was not accepted. Dr Mitchell, the Secretary’s delegate, decided to refuse the application. His reasons were set out in a relatively short letter on 18 August 1997. This is the relevant date for the purpose of subs. 60A(1). The existence of new information pursuant to subs. (8) is to be tested by reference to this date. On 13 November 1997, the applicant sought a review of Dr Mitchell’s decision. This was carried out by Dr Proudfoot, the Minister’s delegate.
8. Dr Proudfoot also refused the application in its entirety. Short particulars of his reasons were set out in the statement provided pursuant to s 37 of the Administrative Appeals Tribunal Act 1975. For some reason that is not immediately clear to me, this statement and all the accompanying documents are presently the subject of an order made under s 35 of that Act and, therefore, cannot be referred to in detail. Dr Proudfoot’s reasons were amplified in an affidavit sworn on 26 October 1998 and lodged with this Tribunal. This affidavit is not subject to a s 35 order. In brief, he rejected a hypothesis based upon the chemical composition rather than the naturally occurring composition of the applicant’s product, a view which does not seem to have been reflected in ADEC’s recommendations. Dr Proudfoot stated in his affidavit that he relied upon certain medical research which he described in detail, being journal articles and findings based upon those articles referred to in a previous decision of this Tribunal (Re Roussel Uclaf Australia Pty Limited and Minister for Family Services (1994) 35 ALD 645). In citing those articles, he disavowed the suggestion that the consequences of the type referred to in that literature would follow from the proposed new indication of the applicant’s product. He went on to say:

“Rather, I cite them in order to illustrate the care drug regulators must exercise in ensuring they do not find false reassurance from a reasonable but unproven hypothesis, and ensuring that they do not allow enthusiasm for an expected or hoped for benefit to outweigh the caution which must be exercised in considering the possibility of rare adverse effects, or adverse effects which may only emerge after years of use.”

9. In paragraph 35 of his affidavit, Dr Proudfoot also referred to evidence that was not before ADEC in relation to the indication which the applicant sought for its product. The information upon which Dr Proudfoot relied was a statement made by a competitor company in relation to its own application for an additional indication in respect of a similar product.
10. It is not necessary to examine the reasons for Dr Proudfoot’s decision in detail at this stage. This will be a matter for the substantive hearing. It is sufficient for present purposes to point out that his decision was not in accordance with the recommendation of ADEC and appears to have been reached by reference to his own researches.
11. Dr Proudfoot’s decision was given on 1 December 1997. An application was made to this Tribunal on 6 March 1998 to have that decision reviewed. Between then and now, there have been a number of conferences. The applicant has lodged with the Tribunal certain reports and associated studies and has made copies of these available to the respondent. The respondent objects to the Tribunal considering this material because of the provisions of section 60A.
12. When the directions hearing was first requested to consider this objection by the respondent, a list of some 13 documents was prepared so as to identify the allegedly objectionable material. The number of documents has now been reduced to 10. It was agreed between the parties that documents 7, 8 and 13 were, in fact, provided with the initial application. The remaining documents are described as follows:
    

#	First Provided	Document dated (on its face)	Document description	Respondent’s position
1.	Letter 22 May 98 (Attchmt A)	20 May 98	A two page summary of #2 and #3 entitled ‘Attachment A. The Hypopituitary control and complication study HypoCCS”, plus a one page table.	The respondent has sought from the applicant more details on the one page table. The respondent reserves the right to object to the Tribunal considering this document.
2.	Letter 22 May 98 (Attchmt A0	4 Nov 97 (Protocol approved 4 November 1997, being an amendment of a protocol which was initially approved prior to April 1997.)	“Protocol B9R-EW-GDDQ(a). The Hypopituitary Control and Complication Study (HYPOCCS)” (for Europe)	No objection to the Tribunal considering the document to the extent that the document indicates that the safety of Humatrope is unacceptable; otherwise objects to the Tribunal considering the document.
3.	Letter 22 May 98 (Attchmt A)	25 Sept 97 (Protocol approved 25 September 1997, being an amendment of a protocol first approved 28 October 1996)	Protocol “B9R-MC-GDEE(a). The Hypopituitary Control and Complication Study (HYPOCCS-I)” (for the United States)	No objection to the Tribunal considering the document to the extent that the document indicates that the safety of Humatrope is unacceptable; otherwise objects to the Tribunal considering the document.
4.	Letter 22 May 98 (Attchmt A)	May 1998	“Investigation of the Safety and efficacy of Growth Hormone Replacement Therapy in Adults with Adult Onset and Childhood Onset Growth Hormone Deficiency: Extension Study Data” (dated May 1998, based on data collected in earlier years)	Objects to the Tribunal considering the document
5.	Letter 22 May 98 (Attchmt B)	Received 6 May 1997 Revision received 3 Sept 97 Accepted 12 Sept 97 Published 1998	“The Australian Multicenter Trial of Growth Hormone (GH) Treatment in GH-Deficient Adults” (Journal of Clinical Endocrinology (1998) vol 83, No.1, 107-116)	Objects to the Tribunal considering the document
6.	Letter 22 May 98 (Attchmt C)	Received 25 July 97 Accepted 15 Sept 97 Published 1998	“Growth Hormone Deficiency in Adulthood and the Effects of Growth Hormone Replacement’: A Review” (1998 journal article; received 25 July 1997, accepted 15 October 1997) (Journal of Clinical Endocrinology, (1998) vol 83, No.2, 382-395)	Objects to the Tribunal considering the document
7.	omitted by agreement
8.	omitted by agreement
9.	Letter 17 July 98	17 July 98	Report of Associate Professor K.Y. Ho, dated 17 July 1998, with curriculum vitae.	The respondent has sought from the applicant more details on the report. The respondent reserves the right to object to the Tribunal considering the document.
10.	Letter 17 July 98	Received 7 May 96 Returned for revision 11 June 96 Finally revised 8 July 96 Accepted 27 Sept 96 Published January 1997	Attachment 4(a) to Associate Professor Ho’s report: “Increased cerebrovascular mortality in patients with hypopituitarism” (Clinical Endocrinology (1997,) vol 46, 75-81)	Objects to the Tribunal considering the document.
11.	Letter 17 July 98	Received 10 Jan 97 Revision received 21 May 97 Accepted 29 May 97	Attachment 4(b) to Associate Professor Ho’s report “Two Years of Growth Hormone (GH) Treatment Increase Isometric and Isokinetic Muscle Strength in GH-Deficient Adults”. (Journal of Clinical Endocrinology (1997), Vol 82, No.9, 2877-2844)	Objects to the Tribunal considering the document.
12.	Letter 17 July 98	Received 5 Aug 96 Returned for revision 27 Sept 96 Finally revised 4 Nov 96 Accepted 6 Feb 97 Published April 1997	Attachment 4(c) to Associate Professor Ho’s report: “The safety profile of GH replacement therapy in adults” (Clinical Endocrinology (1997), vol 46, 75-81)	Objects to the Tribunal considering the document.
13.	omitted by agreement

13. In dealing with the respondent’s objection, it will be necessary to consider section 60A in the context of the statute as a whole, the circumstances of its introduction, and the meaning of some of the phrases used in the section. It will then be necessary to consider each of the above documents individually, and to apply the section 60A criteria, as I understand them, to each document.
14. A purposive approach to interpretation of legislation can be assisted by identifying the “mischief” with which it was intended to deal. This settled technology is discussed in Statutory Interpretation in Australia, 4th edition by Pearce & Geddes at paragraph 2.2. I have attempted to identify the “mischief” in the present circumstances and to understand why it was thought necessary to introduce this amendment. I am not satisfied that I have discovered its purpose.
15. When the Bill was introduced into Parliament, the Second Reading Speech in both Houses contained the following paragraph:

“The appeal provisions in the Therapeutic Goods Act 1989 relating to the review of decisions to register therapeutic goods have also been tightened. This will ensure that technical and scientific data that should be lodged in connection with a general marketing application, will be evaluated before a review on merits is undertaken by the Administrative Appeals Tribunal.”

16. This paragraph simply states the intended effect of the section, and to that extent, provides some assistance in determining the purpose and object of the amendment. It does not, however, identify the reasons which led to the amendment. Ironically, the same speech refers to another intended effect which can hardly be assisted by the operation of this amendment. The Minister said:

“The provisions of this bill will establish a new accelerated process for placing listable drugs supplied in Australia on the Australian Register of Therapeutic Goods, ARTG. This new process will significantly reduce product approval times to a matter of weeks, without in any way affecting the quality or safety of the medicinal products.”

17. The Explanatory Memorandum contained the following paragraph to explain the effect of the changes made to the principal Act:

“(h) [The effect of the changes made will be to....] amend the procedures for reviewing decisions relating to the registration of therapeutic goods in the Australian Register of Therapeutic Goods. The amendment will ensure that any new technical or scientific data lodged by an applicant during review will first be subjected to expert evaluation before a decision on general marketing, based on merit, is made by the Administrative Appeals Tribunal.”

The Tribunal, of course, does not make a decision “on general marketing”. Like the Secretary, it is obliged by s 25 to determine whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established. In this respect the ultimate responsibilities of the Secretary, the Minister and the Tribunal are the same.

18. It is well settled that in general the Tribunal may have regard to new material not before the original decision maker. This flows from the general principle of merits review that the decision to be made is the best or preferable decision at the date of hearing, rather than the best or preferable decision when the matter was before the primary decision maker. Section 60A is directed to upsetting this general principle in relation to review of applications under section 25. Why was this approach taken?
19. I have seen nothing published which might identify any injustice, inconvenience or threat to public safety which might have been feared if the orthodox review procedure were followed. Counsel for the respondent was not able to refer me to any article, seminar, lecture or decision of this Tribunal, where the absence of reconsideration of new information was said to work a mischief.
20. I do not believe that Parliament intended to reflect on the procedural fairness afforded in this Tribunal to all parties. If in the course of a review of a s 25 decision, evidence was tendered which took the respondent by surprise, one would expect all normal procedures to be followed, including an adjournment, if necessary, which would enable the respondent to reply in an informed manner.
21. One possible mischief was identified by counsel for the respondent in a disturbing submission concerning cost recovery. When an application is made for a s 25 decision, a fee is charged based upon the number of pages of material comprised in the application. One that consists of 5,000 pages, for example, attracts a fee of $72,000. Counsel submitted that if any new information was not resubmitted to the Department before being considered by the Tribunal, then the relevant fee would not be recovered and the procedure would defeat, what he termed, “the legislative intention of cost recovery”. Provision is made for payment and recovery of evaluation fees in ss 24A to 24D, but there is nothing in their terms which would suggest an obligation on the part of applicants to maximise the fee payable. I can see no justification for this highly unusual argument in any published references. Certainly the Minister made no reference to this alleged mischief in the Second Reading Speech.
22. Another submission by counsel explaining the background to the legislation was that it was for the protection of the Tribunal. It was submitted that proper evaluation could be carried out only by suitably qualified experts and that it was only on the basis of an evaluation by those experts that a decision could be made by the ultimate decision maker as to whether the therapeutic good ought to be registered. He went on to submit:

“It would be quite impractical for the Secretary (or his or her delegate), the Minister (or his or her delegate) or even the Tribunal to perform the exercise performed by the evaluators. The delegates are appropriate persons to decide, for example (usually with the benefit of multi-disciplinary expert advice from the Australian Drug Evaluation Committee), whether a substance which has a 10 per cent chance of curing a particular condition should or should not be registered if it has a 1 per cent chance of causing some adverse effect. They are not appropriate persons to decide that the substance has that 10 per cent chance of curing the condition or that 1 per cent chance of causing that adverse effect.”

23. This submission is difficult to accept in the abstract and impossible in the present circumstances. Both the Secretary, and the Minister, by rejecting ADEC recommendations and carrying out their own independent researches, performed the very exercise which counsel considered to be quite impractical. I do not suggest that the Secretary or the Minister should be bound by recommendations of ADEC. In my view, however, there is no reason in theory to distinguish between the tasks of the Secretary or the Minister on the one hand, and the Tribunal on the other. As I have said earlier, their tasks ultimately are the same.
24. I find it difficult to accept that the motivation of the legislation is protection of the Tribunal from the burden of assessing evidence. It is a burden that this Tribunal has borne for many years without question. It is a burden which the Tribunal (usually constituted in such cases by expert members) is particularly suited to bear because of the time which the Tribunal has to examine an issue in detail and to hear and assess competing opinions from experts. Its procedures, being quite different from those of ADEC, make it able to bear the burden and to disclaim any necessity for protection.
25. In Re Searle and Minister for Health and Family Services (1997) 47 ALD 333, at 341, the Tribunal said in coming to a conclusion different from that recommended by ADEC:

“(31) In coming to this conclusion, we wish particularly to say that our decision should not been seen in any way as a reflection upon the members of ADEC or of any of its committees. We have had before us considerably more material than was available to ADEC. We have had the advantage of hearing expert evidence given by clinicians and academics of high distinction. The proceedings extended beyond five days, when one takes into account the additional written material put before us. The exigencies of ADEC’s meetings could not have accommodated such a mass of information. If, after a consideration of the oral evidence, the cross-examination and the written material, we come to a conclusion different from that of ADEC, it does not in any way reflect upon the professionalism of that committee. External review necessarily involves a wider and deeper consideration of the matters that were before the original decision-maker. Indeed that is the purpose of external review. We have also had the benefit of detailed written submissions from counsel for both parties and freely acknowledge our indebtedness to them for their assistance in helping to shape and distil such a large quantity of information and advocacy.”

26. In that case, the Tribunal (like the two delegates in the present case) came to a conclusion different from the recommendation of ADEC. In doing so, however, it had the opportunity of considering additional information and hearing and assessing evidence of experts tested in cross-examination by highly-skilled counsel.
27. Protection of the Tribunal, therefore, cannot point to the mischief to be addressed by this legislation. If it were otherwise, the Tribunal would not have the right to consider new information which had not been assessed by ADEC but which was lodged by but was adverse to the applicant (as provided by paragraph 60A(5)(b)) nor would it have the right to consider information which had not been assessed by ADEC where that information came into existence after the date of the s 25 decision nor would it have the right to consider new information which had not been assessed by ADEC where that new information is lodged by the respondent. The fact that the legislation contemplates that the Tribunal may consider new evidence in these three situations indicates that Parliament was not of the view that all material to be put before the Tribunal needed first to be sieved by ADEC or even by the Secretary. There is, of course, no indication in s 60A that any new information that is made available to the Secretary will, in fact, be referred for recommendation to ADEC. In the present case, where the Secretary’s decision was to reject ADEC’s recommendation, it is unlikely that there would be such a referral.
28. It was submitted by counsel that the public health and safety considerations which dominate the Act are sufficient to require the submission of new information before the s 25 decision is reviewed. There can be no question that the Act deals with important matters of public health and safety. The object set out in s 4 emphasises the goals of developing a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods. I fail to see, however, why considerations of this nature were thought to require submission of new information to the original decision maker. Is it to be thought that the Tribunal would not have regard to the object of the Act? Is it to be thought that the decision maker is the sole guardian of public health? Is it to be thought that there is something in the regulation of therapeutic goods which is different in essence from the regulation of other areas of public activity which affect public health and safety?
29. The Tribunal, of course, deals with a wide range of applications in a wide field of public legislation. Questions to be determined, for example under the Meat and Livestock Industry Act 1995, the Mutual Recognition Act 1992, the Australian and New Zealand Food Authority Act 1991 and the Civil Aviation Act 1988, all affect the safety and welfare of members of the public, sometimes to a high degree. Yet in none of these statutes has Parliament considered it necessary to deal with new information in the way contemplated by s 60A.
30. The mischief which the section seeks to address, therefore, remains obscure. The effect of the section is to disadvantage an applicant before this Tribunal, to advantage the decision maker, and to bypass the Tribunal. On one view, the section could operate unfairly so as to give an applicant no opportunity to address what might be called a wildcat decision. I do not suggest for a moment that Dr Proudfoot’s decision could be put in this category. If, however, a totally unexpected and unjustifiable decision were made, based on material not before ADEC, then an applicant would be denied the right to provide fresh information to contradict an unjustifiable result. I will return to this argument later in considering the meaning of relevance in paragraph (8)(c). For the present, it is sufficient to note that there is no obvious publicly known paradigm which this section seeks to alter. Construction of the section cannot therefore be assisted by having regard to the public good which it seeks to achieve. Its construction must be in accordance with a legislative purpose discerned from the legislation itself, in accordance with well-settled principles recently re-stated by the High Court in Project Blue Sky Inc v Australian Broadcasting Authority [1998] HCA 28; (1998) 153 ALR 490.
31. The meaning of s 60A is clear, except for the meaning of “new information” as defined in subs. (8). In relation to the application of that definition, it will therefore be necessary to determine the meaning of the phrases, “in existence”, “not made available”, and “is relevant to that decision”. I now turn to a consideration of these terms.
32. It should be noted firstly, that s 60A has application only when an applicant lodges new information either with the Minister or relevantly with the Tribunal. The appropriate meaning of “lodge” given by the Macquarie Dictionary is “to put or deposit, as in a place, for storage or keeping”. Lodging new information, therefore, must mean lodging information in tangible form, either as a document or as an electronic record. The words of the section could not support an interpretation which encompassed the giving of oral evidence. Thus if a witness called by the applicant gives oral evidence in chief or in cross examination which refers to information which might otherwise have fallen within the definition of new information if it were in writing, then there can be no objection to the Tribunal considering it on an unrestricted basis. Contrary to a submission by counsel for the respondent, “lodgement” is a precondition for the operation of the section. If this produces an unexpected result, it may only mean that the drafter has given consideration to the standard practices of this Tribunal when reviewing decisions. It would be quite impractical to interrupt cross examination constantly to detect and reject unacceptable references to past knowledge.
33. It is necessary to determine the meaning of “in existence” appearing in paragraph (8)(a). The first observation to make is that even the respondent concedes that it cannot be interpreted literally. New information includes opinions. Opinions from experts may be based not only upon specific areas of knowledge, such as the results published in a scientific paper, but also upon the ability of the commentator to offer that opinion.
34. In paragraphs 60 and 61 of the respondent’s submissions, an acknowledgment is made that some line must be drawn:

60. Professor Ho’s report also contain various statements that are presumably based on Professor Ho’s general knowledge, experience and expertise, gained long before the critical date (for example, paragraphs 1.1, 1.2 and 3.2). The respondent accepts that basic medical information (for example of the kind that would be found in a standard medical reference text such as Harrison’s Principles of Internal Medicine) are implicit in the information submitted with an application for s 25 registration.
61. However, if the applicant wishes to rely on information and opinions from Professor Ho (based on his experience and opinions) that go beyond this basic or “standard” medical knowledge then, again, the appropriate time to have said so was in its s 25 application papers, so that the statements could have been properly evaluated. Having failed to do this, the s.60A(5) prohibition must attach to the statements.”
    

35. If new information is not to include “basic medical information”, what other information is to be excluded in determining whether the information was in existence at the relevant time? If information consists of discussions, unpublished lectures, views exchanged at seminars or conferences or the like, is a written report lodged with the Tribunal to be ignored because it makes reference to any such form of information that was created before the relevant date? In my view, this would lead to an absurd result. The use of the term “lodges” in conjunction with the phrase, “in existence” seems to me to point to the area to which the subsection is directed. It must surely mean information in a tangible, written form, which is publicly available. The applicant submitted that the phrase “in existence” should be restricted to situations where information is product-specific and consists of technical or scientific data in an applicant’s exclusive custody or control, having been generated by it for its product which it elects not to make available for evaluation by the respondent when lodging an application pursuant to s 23. In my view, this goes to the other extreme. There is nothing in the language which would compel a meaning hedged about with so many restrictions. None the less, the use of the word “should” in the Second Reading Speech does give some weight to the submission. The use of the word “should” indicates a failure on the part of an applicant to meet what might be called an unspoken obligation to disclose the whole of its case without deliberately withholding any part of its case so that it may surprise the respondent on a review.
36. On either reading, it seems to me that material not in the public domain cannot be included in the term “in existence”. For example, a number of the documents under consideration are published articles. Because those articles are subject to peer review, which is a lengthy process, it is customary for technical publishers to show the date upon which the manuscript was received, the date on which a revision was received, the date of acceptance and the date of publication.
37. The original manuscript and any revised version would not be publicly available. It would not be available to any person except the authors and the publishers. It seems to me that the section cannot be aimed at information of this kind. There is no certainty that ultimately the manuscript would be accepted or that it would appear in the form propounded by its authors. In the case of journals, it seems to me that information falling within the terms of the definition does not come into existence until such time as it is published. It is altogether too narrow a view to claim that information is in existence immediately it is printed out in draft form. Counsel for the respondent submitted:

“49. To confound “publication” with “existence”:

• fails to apply the plain meaning of the word “existence”;
• would require words to be read into s 60A(8) to the effect that it said “was in existence and available to the sponsor at the time the decision referred to in subsection (1) was made...”
• would fail to carry out the predominant legislative intention that (save in very narrow circumstances), the Tribunal should not, because of the public interest in rigorous evaluation, be required to assess unevaluated information. In this respect, if there is any ambiguity in the provision (which is denied), it must be resolved in favour of the predominant legislative intention (as expounded in Part I of these submissions: see especially paragraphs 29 and 30).”
  

38. In my view, it is not necessary to read words into the section to understand that the words “in existence” means a tangible document created after the relevant date, whether or not contributions to its creation were made before the relevant date.
39. It is necessary to consider the meaning of the phrase “not made available”. It is difficult to conclude that new information must be physically put into the Secretary’s hands. It must surely be sufficient to quote a reference in a well-known journal, the contents of which would be available to the Secretary. If this be so, it is also conceivable that the availability test has been satisfied by other means than direct delivery of a hard copy. For example, as it happened, one of the authors of one of the studies to which the respondent has taken objection was a member of ADEC and, in fact, attended the meeting at which the subject application was considered. The existence of the “new information” would certainly have been known to him and one imagines from the collegiate way in which ADEC operates, would have been known to the whole of that body in advising the Secretary. Thus, in my view, a practical approach to the words “made available” will include the act of making the Secretary aware of the new information, either directly or via the collegiate recommendation of ADEC. Such a construction, in my view, would promote the purpose or object of full disclosure.
40. Paragraph (8)(c) requires that the new information be relevant to the s 25 decision. In a sense there is no difference between any of the decisions. As I have said, the Secretary, the Minister and this Tribunal all have the same decision-making task. If information is relevant to the one, then it is relevant to the other two decisions.
41. In order to constitute new information, the material must comply with the criteria of all three paragraphs in subsection (8). If it was not in existence at the relevant time or if it was informally made available to the Secretary or it was not relevant to the s 25 decision, then it does not fall within the terms of the definition.
42. Most of the documents in the above schedule fail to comply with the first criterion. If one is to analyse a report in a piecemeal fashion then it has to be said that items 10 and 12, being attachments to Professor Ho’s report, must fall within the definition of new information. On any test, they came into existence before the relevant date and are said to be favourable to the applicant’s case. They therefore may not be considered by the Tribunal unless referred back for re-evaluation.
43. In relation to all the other documents, however, it seems to me that the existence, availability and relevance tests have not been met. The actual documents that comprise items 2 and 3 and, therefore, the information contained in the summary in item 1 came into existence after the critical date. In my view, this is sufficient in itself to take them out of the parameter of the definition.
44. Again, item 4, although referring to clinical and statistical data and opinions based on that data collected before the critical date, itself came into existence after that date. It is not, in my view, a re-packaging intended to obviate the operation of the section. Applying what I believe to be a practical test of judging the date of information objectively, the report may be considered. In relation to this report, counsel submitted:

“45. If the Tribunal is required to have regard to item #4, it will be required to evaluate the importance (or non-importance, as the case may be) of these matters; and the weight that should be given to the report generally; and what is to be made of the date presented in the report; without the benefit of independent analysis, that is, analysis from expert evaluators other than those engaged by the applicant. In particular, the Tribunal would be required to evaluate a complex study without the assistance of the independent evaluation performed on behalf of the TGA, without the assistance of the views of ADEC, and without the assistance of the delegate or reviewable decision maker (themselves qualified medical practitioners). The Tribunal would have to carry out a task which the TG Act never contemplated would be carried out by the Tribunal.”

45. As I have previously said, there is no reason from a policy point of view, why the Tribunal should not be called upon to evaluate a study without the assistance of those who fruitlessly advised the decision maker.
46. Again in item 5, the critical date is the publication date so that the information was not in existence at the relevant time. Similarly item 6, published well after the relevant date, falls outside the terms of the definition. Again Professor Ho’s report in item 9 (the principal document in dispute) whilst based upon old information, did not come into existence until after the critical date. It would not have been necessary for this report to have accompanied the initial application. The report addresses what Professor Ho sees as the flaws in the independent reasoning and decision of Dr Proudfoot. Whether one opinion or the other is to be preferred is a matter for the substantive hearing.
47. Item 11 was not published before the critical date. Accordingly, it fails to qualify as new information and may be considered by this Tribunal.
48. On the basis of the above reasoning I will direct that documents 10 and 12 in Appendix 1 to the respondent’s Supplementary Statement of Facts and Contentions on s 60A issues be not considered by the Tribunal. I direct that all other documents referred to in that appendix may be considered at the substantive hearing. Section 69A(3) provides for a discretion to remit. As I read the subsection, if these 2 documents constitute new information as I have held, the remittal will be not those 2 documents above but the whole “matter”. This seems to mean more than the application before the Tribunal. The subsection seems to indicate that the whole s 25 application must be remitted to the Secretary’s delegate for a fresh decision. Thus the process of internal and external review would start again. The applicant may prefer to rely on the direction I propose rather than suffer any further delay. The delegate has, of course, had this new information, although not remitted by this Tribunal, for more than 6 months. In case the applicant wishes “the matter” to be remitted, I will reserve liberty to apply.
    

I certify that this and the 18 preceding pages are a true copy of the decision and reasons for decision herein of

Deputy President BJ McMahon

Signed: .............................................................................

Associate

Date of Directions Hearing 25 January 1999

Date of Directions 8 February 1999

Counsel for Applicant Mr P Dwyer

Counsel for Respondent Mr G Loughton