The first decision
67 SmithKline submitted that, on the assumed facts, the decision to register Ausrox had been taken, in part at least, upon the basis of information which it had supplied in relation to its own product, Aropax. There had been no evidence that Ausrox was a safe or effective drug.
68 Smithkline further submitted that, on the assumed facts, and on the inferences properly to be drawn from those facts, the first decision had the potential to affect its interests adversely. That was because:
· it represented a departure from previous practice, and from the TGA's own guidelines.
· it constituted a rejection of the representations consistently made by SmithKline to the TGA that new pharmaceuticals should not be registered without appropriate pre-clinical and clinical trials.
· it gave rise to serious safety risks.
· it had the potential to undermine public confidence in the drug approval process.
· it had the potential to undermine the reputation, integrity and acceptability of Aropax, and thereby cause significant harm to SmithKline.
· any adverse reactions to Ausrox would almost certainly be referred to the SmithKline's own adverse reactions monitoring program. It would be difficult, if not impossible, to determine which drug had caused any such reaction; and
· SmithKline's ability to monitor the performance of Aropax would be compromised.
69 SmithKline noted that the respondents' primary submission was that it had no standing to seek reconsideration of the first decision, whether by merits review, or by judicial review. There was, therefore, some irony associated with the respondents' alternative submission that judicial review should be refused, in the exercise of the Court's discretion, because of the availability of merits review as an adequate alternative remedy.
70 SmithKline challenged the respondents' submission that, upon the proper construction of s 60, a favourable decision upon an application for the registration of a therapeutic good was conclusive, and immune from all review. It submitted that, on the assumed facts, the first decision was a nullity. Given the adverse effects which that decision might have upon it, the conclusion that SmithKline lacked any recourse, whether by way of merits or judicial review, was one which ought not lightly be reached.
71 SmithKline accepted that the Act made no mention of this Court's jurisdiction. However, it submitted that this was of little consequence in determining whether judicial review was available: Magrath v Goldsborough, Mort & Co Ltd (1932) 47 CLR 121 at 134 where Dixon J said:
"The general rule is that statutes are not to be interpreted as depriving superior Courts of power to prevent an unauthorised assumption of jurisdiction unless an intention to do so appears clearly and unmistakably."
72 SmithKline noted that this passage had been referred to and applied by Black CJ as a member of the Full Court in Shergold v Tanner (2000) 102 FCR 215 at 220. In that case the Court held, by majority, that a decision by a Minister to issue a certificate identifying a document as an "exempt document" under the Freedom of Information Act 1982 (Cth) ("the FOI Act") was amenable to judicial review despite the fact that the Act provided that the effect of such a certificate was to "establish conclusively" that such a document was exempt.
73 In rejecting a submission that the relevant decision was not amenable to judicial review, Finkelstein J said at 247:
"If the applicant is correct, the fundamental principle that the court will intervene to ensure that the power of a public authority is exercised lawfully (R v Lord President of Privy Council; Ex parte Page [1993] AC 682 at 701) will be defeated."
74 His Honour went on to say at 252:
"It is now beyond argument in this country that when a person, such as the Minister, is given power by statute to make a decision that would affect some person by altering his rights or obligations or by depriving him of some benefit or advantage, the decision is amenable to judicial review."
75 In Shergold v Tanner [2002] HCA 19, the appeal from the decision of the Full Court was dismissed. It is noteworthy that the High Court made no criticism of the fact that the respondent in that case sought to challenge, by judicial review, the decisions of the delegate of the Minister to exercise the powers conferred by the relevant sections of the FOI Act, rather than seeking merits review, which was also available.
76 Observations of a similar nature to those expressed by Finkelstein J in the Full Court have also been made by Kirby J in Allan v Transurban City Link Ltd (supra) at par 73 and, in the context of what are described as "the constitutional writs" in Abebe v Commonwealth (1999) 197 CLR 510 at 537.
77 SmithKline challenged the respondents' submission that Alphapharm had established that a favourable decision under s 25 of the Act was not amenable to judicial review. It submitted that the question in that case had been whether, pursuant to s 60, such a decision was amenable to merits review, initially by way of reconsideration by the Minister, and then by way of review by the AAT. The issue of judicial review had not arisen for determination, a fact expressly noted by Davies J at 259-260. Indeed, his Honour observed that the question of standing might be determined differently depending upon whether what was at issue was merits review or judicial review. He said at 260:
"This must be so with respect to the phrase "interests are affected", when used in a statute which provides for the administrative review of administrative decisions. In such event, the review, which forms part of the process of administrative decision-making, is provided to promote the achievement of the objects of the statute. The term "aggrieved", when used in the context of judicial review, may have a different connotation, for the object of judicial review is to ensure that the law is observed."
78 The applicant also noted that Davies J had said, at 263, that if SmithKline had demonstrated a relevant interest, it would not have been disentitled by the fact that the drug had been registered. SmithKline had failed, in Alphapharm, because the only interest put forward on its behalf was an interest in "delaying or hindering the introduction of the drug onto the market": see 261-262. Had there been evidence supporting the contention belatedly made from the bar table on its behalf that the use of Alphapharm's product posed risks to its commercial reputation, SmithKline may well have had standing to seek merits review. Importantly, in his Honour's opinion, a decision for the purpose of s 60 encompassed both registration and refusal to register.
79 The applicant submitted that although Gummow J in Alphapharm held that a favourable decision to register was not subject to merits review by a third party, his Honour did not say anything to suggest that such a decision was immune from judicial review.
80 As noted earlier, Burchett J agreed with both Davies J and Gummow J, thereby depriving Alphapharm of any binding authority on this point.
81 SmithKline submitted before me that if the decision to register Ausrox was amenable to judicial review, there was no doubt that it had standing to seek such review. Plainly, it had a "special interest" in the subject matter of the proceeding: Australian Conservation Foundation v The Commonwealth (supra) at 530-531; Onus v Alcoa of Australia Ltd (supra) at 35-36, 41-42 and 74; Davis v Commonwealth (supra); Shop Distributive and Allied Employees Association v Minister for Industrial Affairs (SA) (supra); Bateman's Bay Local Aboriginal Council v The Aboriginal Community Benefit Fund Pty Ltd (supra) at 267; Transurban City Link Ltd v Allan (1999) 95 FCR 553 at 565; and North Australian Aboriginal Legal Aid Service Inc v Bradley [2001] FCA 1728 at pars 28-64.
82 SmithKline submitted that none of the authorities cited by the respondents supported the proposition that, merely because it was a commercial rival of the fourth respondent, it lacked standing. Indeed, there was authority for the contrary view: see Bateman's Bay at 274.
83 For these reasons, SmithKline submitted that, on the assumed facts, it plainly had a "special interest" in the subject matter of the proceeding. That interest was not "a mere intellectual or emotional concern". SmithKline stood to gain an important advantage, apart from the satisfaction of righting a wrong, if its challenge to the first decision were successful. SmithKline had also shown that it might suffer special damage, peculiar to itself, if that decision were permitted to stand. Apprehended harm was sufficient, particularly when the risk of that harm was neither remote nor indirect.
84 SmithKline also submitted that the assumed facts showed that the first decision involved a rejection by the TGA of legitimate representations which it had consistently made over a long period of time regarding public health and safety. Those facts also showed that SmithKline had been denied natural justice. That alone was sufficient to demonstrate that it had standing to seek judicial review: Alphapharm at 260-261 per Davies J and at 266 per Gummow J.