FEDERAL COURT OF AUSTRALIA

Pfizer Pty Ltd v Birkett [1999] FCA 1778

PFIZER PTY LTD v BIRKETT & ORS

N 1120 OF 1999

JUDGE:          MATHEWS J

DATE:            8 DECEMBER 1999

PLACE:          SYDNEY

THE COURT ORDERS THAT:

1.      The two affidavits of Christopher Gordon McMahon, sworn respectively on 9 November 1999 and 6 December 1999, are rejected.

Note:    Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

REASONS FOR JUDGMENT

1                     The applicant has sought to read two affidavits of Christopher Gordon McMahon, sworn respectively on 9 November 1999 and 6 December 1999.  Mr Downes QC, for the respondents has objected to both affidavits in their entirety.

2                     Without going into details of the contents of the affidavits, Dr McMahon, who is a highly qualified medical practitioner specialising in male sexual medicine, refers in his first and primary affidavit, to a large number of issues relating to the use of alprostadil (Caverject) and of sildenafil (Viagra).

3                     He reaches the following conclusion in paragraph 36 of his affidavit:

“I am of the opinion that Alprostadil is not available to treat patients in many cases where use is clinically necessary and cost-effective.”

4                     In paragraph 42 he refers to that opinion and continues:

“I am also of the opinion that the material and data available to the medical community did not reveal that Alprostadil was meeting the needs of the target population, and therefore that Alprostadil did not appear to be meeting the needs of the target population.”

5                     Dr McMahon referred to a large number of articles from medical journals and other sources in his affidavit.  He went on to say that the documents produced by the respondents contained no reference to any of these articles.

6                     Mr Robertson SC, in urging the admissibility of Dr McMahon’s affidavits, relies upon statements made in the statement furnished by the respondents under section 13 of the ADJR Act, and also in the respondents’ minutes of the June 1999 meeting at which the relevant decision was made.

7                     The relevant paragraph in the section 13 statement (para 4.5) is in the following terms:

“Alprostadil injections have been accepted by the Committee as producing a high degree of effectiveness and are available under the PBS to treat patients where use is accepted by the Committee to be clinically necessary and where use is cost effective.”

8                     Paragraph 7.2.19 of the minutes is in the following terms:

“The Committee also noted that intracavernosal alprostadil an effective preparation which was more likely to be able to be restricted to situations where use is clinically justified and cost-effective, remained available and appeared to be meeting the needs of the target population. Therefore, in view of the concerns outlined above, members concluded that the application should be rejected.”

9                     Amongst the grounds relied upon by the applicant in this case, is a ground under s 5(1)(h) of the Administrative Decisions Judicial Review Act 1997 (Cth)(“the ADJR Act”), namely that there was no evidence to justify the making of the decision.  Under s 5(3)(b), that ground will not be made out unless the decision was based on the existence of a particular fact and that fact does not exist.  As Mr Robertson points out there are two considerations under this ground.  A person challenging an administrative decision must first establish that the decision was based on the existence of a particular fact and must also prove the non-existence of that fact.

10                  For the purpose of proving the non-existence of a relevant fact, it is permissible for an applicant to rely upon material which was not before the decision maker.  This is the primary purpose of Dr McMahon’s affidavit, according to Mr Robertson, namely to prove the non-existence of facts upon which the respondents were said to have based their decision.  It is in this context that Mr Robertson referred to the statements, quoted above, in the section 13 statement and the respondents’ minutes.

11                  However, when one turns to those documents, the “facts” which Mr Robertson relies upon as being disproved by Dr McMahon's affidavit turn out to be not matters of fact at all but rather expressions of opinion.

12                  Going first to para 4.5 of the section 13 statement: this refers to alprostadil injections being accepted by the Committee as producing a high degree of effectiveness.  Dr McMahon expresses the view that alprostadil is not a highly effective remedy for erectile dysfunction.  But this will not avail the applicant in these proceedings.  Section 5(3)(b) of the ADJR Act relates to the existence of facts, and is clearly not applicable to statements of opinion.  Opinions are not generally capable of existing or not existing, and certainly cannot be disproved by showing that a particular expert, no matter how well qualified, holds a contrary opinion.

13                  The statements in the minutes which Mr Robertson seeks to disprove through Dr McMahon’s affidavit are that alprostadil “remained available and appeared to be meeting the needs of the target population”. This statement contains two assertions: first, that alprostadil remained available, and secondly that it appeared to be meeting the needs of the target population.  The first assertion, namely that alprostadil remained available, is an assertion of fact which is clearly accurate.  Alprostadil injections were indeed available at the relevant time under the Pharmaceutical Benefits Scheme.  The second assertion is a matter of opinion only, and cannot, as already indicated, be disproved by the assertion of a contrary opinion.

14                  The second basis relied upon by Mr Robertson for seeking to read Dr McMahon’s affidavit relates to the ground of review set out in paras 5(1)(e) and 5(2)(g) of the ADJR Act, namely that the respondent's decision was so unreasonable that no reasonable person could have exercised the power as it did.  This ground is raised in paragraph 12 of the applicant's amended application.  In particular Mr Robertson relies on paragraph 12(c) which is in the following terms:

“The respondents assumed that alprostadil was meeting the needs of the targeted population and that alprostadil injections were available to treat patients where use was clinically necessary in circumstances where there was no evidence or other material to support those conclusions and where the respondents themselves decided to investigate the possibility of a tighter restriction to limit the use of alprostadil injections to particular patient groups.”

15                  It is suggested that learned articles, which had apparently not been referred to by the respondents, advanced this ground.

16                  An immediate issue arises as to the admissibility of material which was not before the respondents when they made their decision.  In this regard, Mr Robertson has referred me to the judgment of Wilcox J in Prasad v Minister for Immigration and Ethnic Affairs (1985) 6 FCR 155 at 169.  Here his Honour referred to the relevance to the issue of “reasonableness” of certain material which had not been before the decision maker in that case.  His Honour went on to refer to three possible views as to the admissibility of that evidence.  The “intermediate position” as his Honour described it, was as follows:

“that the Court is entitled to consider those facts which were known to the decision maker, actually or constructively, together only with such additional facts as the decision-maker would have learned but for any unreasonable conduct by him.”

17                  This was the position which his Honour adopted in that case, and which I agree is appropriate here.

18                  It is clear from the terms of paragraph 12(c) of the amended application that the applicant is not seeking to rely upon any unreasonable failure on the part of the respondents to refer to the articles described by Dr McMahon.  On the contrary, it is relying upon the proposition that there was no evidence or other material to support the conclusions drawn by the respondents.

19                  In my view the material contained in Dr McMahon's affidavits do nothing to further the applicant's claim as expressed in paragraph 12(c) of the amended application.   I can therefore find no relevant basis for admitting the affidavits, and they are therefore rejected.

Associate:

Dated:              17 December 1999