Alphapharm Pty Ltd v. Smithkline Beecham (Australia) Pty Ltd

(1994) 49 FCR 250

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(Judgment by: Burchett J) Court:

Judges: Davies J

Burchett JGummow J

Judgment date: 31 March 1994

Sydney

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Judgment by:
Burchett J

I agree with Davies J and Gummow J that these appeals must succeed. The issues on which we are differing from the learned trial judge are really quite narrow, and I can state my view of them fairly briefly.

In the first place, I note the acceptance, in the judgment under appeal, of the proposition that the understandable concern of the respondent (by which expression I mean to include both SmithKline Beecham (A Pty Ltd and SmithKline Beecham Laboratories (Australia) Ltd) to maintain its monopoly by persuading the appropriate authority to shut out a competing product does not make the respondent a "person whose interests are affected" within s 60(2) of the Therapeutic Goods Act 1989 (Cth). This must be right. The other view would turn legislation, one of the express objects of which (see s 4) is to provide for the "timely availability of therapeutic goods", into legislation setting up institutional provision for delay.

However, the judge accepted a submission that error should be detected in the language in which the decision of the administrator was conveyed to the respondent. The relevant letter put the matter as follows:

I have decided that your letter is not a valid request for review under s 60 of the Act. My reasons for reaching this view are as follows:

You are seeking review on behalf of your client, SmithKline Beecham Laboratories (Australia) Ltd. The grounds given for your request are that your "client's interests are affected by the decision to allow Alphapharm's cimetidine to be placed on the Therapeutic Goods Register". In referring to your client's interests, I assume you mean your client's commercial interests.

Your client is seeking to use the review process provided under s 60 of the Act for commercial purposes rather than for those purposes outlined in the scheme of the legislation. Therefore, in my opinion, your client does not have sufficient standing to bring an application for review under s 60 of the Act. (See decision of the Administrative Appeals Tribunal in Re Smith & Nephew (Australia) Pty Ltd and the Department of Health, Housing and Community Services V92/649, 6 November 1992 .)

It was the reference to "commercial purposes" which was said to involve error, on the basis that the purpose sought to be served by a person interested is irrelevant to the existence of the interest.

But this is to pluck a single comment out of its context in the letter, so as to make of it a free-standing pillar supporting the decision. I cannot agree to read the letter in that way. It seems to me the writer is not ultimately speaking of the ends being served by the respondent, but of the nature of its application. The application, which would have made the review process serve commercial purposes other than the purposes of the Act, demonstrated, or at least emphasised, the respondent's lack of standing. To say so was not to stray from the correct path of a decision on the question of standing. The respondent's application was not rejected because its purposes were impure, but because, having regard to those purposes as clear indicators of how far the interests it was asserting were from the interests with which the Act is concerned, it had no standing to apply. That this was the true meaning of the letter is confirmed by the reference at the end to the decision of the Administrative Appeals Tribunal in Smith & Nephew (Aust) Pty Ltd v Department of Health, Housing and Community Services (J Handley, Senior Member, 5 November 1992 ). The relevant proposition in that decision, which actually turned on another point, was expressed in different places in the decision, as that "there was considerable doubt whether the applicant had lawful entitlement to bring these proceedings", and as that there was "considerable doubt whether the applicant is competent to bring these proceedings".

In any case, I am clearly of the opinion that it was not open to the decision-maker to have come to any other conclusion than that to which he came. If that is so, the suggested error in his reasoning can be of no significance: BTR Plc v Westinghouse Brake and Signal Co (Australia) Ltd (1992) 34 FCR 246 at 254 ; 106 ALR 35 . The only ground suggested in the judgment below for finding that the respondent's interests were relevantly affected was a ground not put in the application with which the decision was concerned. It was said the administrator should nevertheless have realised it was to be relied on. I find nothing to support that suggestion. Statements made at other times, and for other purposes, but not repeated when the application in question was made, were not, in the circumstances of this case, in the least likely to have been present to the decision-maker's mind, and there was no error of law involved in his not having had regard to them.

Even if the decision-maker should have had regard to these statements, they could not, in my opinion, have provided a basis on which it would have been open to him to have decided otherwise than he did. The issue it is alleged the respondent should be taken to have raised related to the integrity and suitability of the drug in respect of which another company had obtained registration. I do not think the respondent had standing to seek a review under s 60 on such a basis. It was the Secretary who had the statutory responsibility to ensure that full weight was given in the making of the decision to questiions of safety and other relevant matters. In respect of those questions, the respondent had no interest of its own beyond that which it shared with the wider public. As Mason J said, agreeing with Gibbs J, in Australian Conservation Foundation Inc v Commonwealth (1980) 146 CLR 493 at 547 ; 28 ALR 257 at 284 :

... apart from cases of constitutional validity ... a person, whether a private citizen or a corporation, who has no special interest in the subject matter of the action over and above that enjoyed by the public generally, has nolocus standi to seek a declaration or injunction to prevent the violation of a public right or to enforce the performance of a public duty.

Sometimes the possession of a right to be heard in an inquiry or other proceeding may, in itself, demonstrate a sufficient interest to maintain an action aimed at ensuring the legality of the conduct of the inquiry or proceeding. This was the view of Barwick CJ in Sinclair v Mining Warden at Maryborough (1975) 132 CLR 473 at 478 ; 5 ALR 513 , and it was accepted by Gibbs J in Australian Conservation Foundation v Commonwealth at CLR 532. A case illustrating the point is Australian Conservation Foundation v Forestry Commission (1988) 79 ALR 685 , where (at 689) I held that persons given leave to appear before the Commission established under the Lemonthyme and Southern Forests (Commission of Inquiry) Act 1987 (Cth) had locus standi to seek judicial review of a decision of the Commission; "The applicants, who were given leave to appear by the Commission and did participate in its hearings, had a right to have their submissions considered according to law." But this case is the converse. The respondent had no right under the statute to be heard upon the original consideration of the matter.

In my vew, it was not open to the decision-maker to conclude that the respondent had a sufficient interest to request the minister to reconsider the decision under s 60. Accordingly, the appeals should be allowed, and the further orders which are proposed by the presiding judge should be made.