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

(1994) 49 FCR 250

(Judgment by: Davies J) Court:
Federal Court of Australia

Judges:
Davies JBurchett J
Gummow J

Judgment date: 31 March 1994

Sydney

Judgment by:
Davies J

This is an appeal from a judgment of a judge of the court, Beazley J. A question before her Honour was whether SmithKline Beecham (Australia) Pty Ltd (SmithKline) was a person the interests of which were affected by a decision made under the Therapeutic Goods Act 1989 (Cth) (the Act), and which was, under s 60(2) of the Act entitled to lodge a request that the minister reconsider that decision.

The case as presented to the trial judge resolved into three issues. The first was whether SmithKline was entitled to a mandatory order that the minister reconsider the initial decision, which he had refused to do in pursuance of a request made by letter dated 8 June 1993 . The second was whether, even if SmithKline was a person the interests of which were affected by the initial decision, SmithKline was nevertheless not entitled to seek that reconsideration because the letter of 8 June 1993 had been written in the name of SmithKline Beecham Laboratories (Australia) Ltd (SmithKline Laboratories). The Third issue was whether the application to the court should be amended by substituting SmithKline for SmithKline Laboratories, in whose name the proceedings in the court had been commenced.

The trial judge found for SmithKline on the second and third points and, on the first point, without determining whether SmithKline had relevant interests which were affected by the initial decision, remitted the matter to the minister for re-determination according to law.

Section 3(1) defines "sponsor" in relation to therapeutic goods as meaning, inter alia:

(b)
a person who imports, or arranges the importation of, the goods into Australia; or
(c)
a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere)...

Alphapharm Pty Ltd (Alphapharm) was the sponsor in relation to a product described as "generic cimetidine".

Section 20(1) of the Act provides that a person who is the sponsor of therapeutic goods must not import the goods into Australia or manufacture the goods in Australia for use in humans or supply the goods in Australia for use in humans unless "(e) the goods are registered goods or listed goods in relation to the person". Section 17(1) of the Act provides that the Secretary is to cause to be maintained a register to be known as the "Australian Register of Therapeutic Goods" for the purpose of compiling information in relation to, and providing for an evaluation of therapeutic goods for use in humans. Section 26 of the Act provides for the listing of therapeutic goods. Section 23(1) provides for the lodging of an application for registration or listing of therapeutic goods.

Alphapharm applied in 1987 or earlier for the registration of generic cimetidine.

It is a principle of the Act and of the Therapeutic Goods Regulations (the regulations) that, after the lodgment of an application for registration, the goods will pass through a process of testing and evaluation. Part V of the regulations provides for the examination, testing and analysis of goods.

Part VI of the regulations provides for the establishment of a committee of experts entitled "The Therapeutic Goods Committee" which is to advise the minister on standards related to therapeutic goods. The Part also establishes the Australian Drug Evaluation Committee, a function of which is "(a) to make medical and scientific evaluations of any drugs that the Minister or the Secretary refers for evaluation". Regulation 36 requires the membership of the Australian Drug Evaluation Committee to consist of six or seven core members and of between 10 and 20 associate members. Of the core members, at least three persons shall be medical practitioners eminent in the medical profession, at least two shall be specialists in clinical medicine. At least one of the core members is to be a pharmacologist or shall hold a university degree in science or a branch of science and shall have specialised in pharmaceutical science. The associate members are to consist of persons who are pharmaceutical chemists with recent experience in the manufacturing of therapeutic goods or toxicologists or medical practitioners currently engaged in general practice or medical practitioners with specialist qualifications and experience in a field of medicine that complements the expertise of core members with medical qualifications.

Although there was no evidence about the matter, it may be assumed that Alphapharm's application for registration underwent appropriate examination, testing and analysis and was referred to the Australian Drug Evaluation Committee for its evaluation.

In this process, SmithKline played no part save in two respects. In the first place, the solicitor for Smith Kline & French Laboratories Ltd and Smith Kline & French Laboratories (Australia) Ltd (which subsequently became SmithKline Laboratories) wrote to the Secretary of the Australian Drug Evaluation Committee on 15 October 1991 advising that the Alphapharm cimetidine was of a different composition to the Smith Kline & French cimetidine, that it constituted a different therapeutic good to the Smith Kline & French product and that the sale of Smith Kline & French cimetidine over the years provided no assurance of the safety and efficacy of the Alphapharm product. The letter of 15 October 1991 pointed out:

In those circumstances it seems to us that any evaluation which ADEC makes of the Alphapharm product must be made on the basis that ADEC is satisfied:

(a)
of the precise polymorphic form of the Alphapharm product; and
(b)
if the polymorphic form differs from that of the SK & F product, that Alphapharm has conducted a full testing procedure to establish the safety and efficacy of the Alphapharm product.

The solicitor also wrote on the same day to the Secretary, Department of Health, Housing and Community Services to put the department on notice that his clients may wish to challenge any decision and may do so under the Act and the Administrative Appeals Tribunal Act 1975 (Cth) (the AAT Act) or under the Administrative Decisions (Judicial Review) Act 1977 (Cth) (the ADJR Act).

The second aspect of the involvement of the Smith Kline & French companies in the process was that the companies instituted proceedings in the the Federal Court seeking orders precluding the use of confidential Smith Kline & French information in the evaluation of Alphapharm's generic cimetidine. Decisions with respect to that matter have been reported at (1989) 89 ALR 366 ; (1990) 22 FCR 73 ; (1991) 99 ALR 417 ; (1991) 28 FCR 291 .

The Alphapharm cimetidine was placed on the register on 18 February 1993 . That was the initial decision of which SmithKline subsequently sought reconsideration. The solicitor who had written to the Australian Drug Evaluation Committee on 15 October 1991 was informed of the registration of Alphapharm's generic cimetidine by letter from the Department of Health, Housing and Community Services dated 11 March 1993 .

Section 60 of the Act provides, inter alia:

(1)
In this section:
"decision" has the same meaning as in the Administrative Appeals Tribunal Act 1975;
"initial decision" means a decision of the Secretary or of a delegate of the Secretary:

(a)
under the definition of "therapeutic devices" in subsection 3(1) or under subsection 7(1); or
(b)
refusing to grant a consent under section 14; or
(c)
under Part 3 or 4;

"reviewable decision" means a decision of the Minister under subsection (3).
(2)
A person whose interests are affected by an initial decision may, by notice in writing given to the Minister:

(a)
in the case of a decision particulars of which are required to be notified in the Gazette - within 90 days after those particulars are so notified; or
(b)
in any other case - within 90 days after the decision first comes to the person's notice;

request the Minister to reconsider the decision.
(3)
The Minister must, as soon as practicable after receiving a request under subsection (2), reconsider the initial decision and, as a result of that reconsideration, may:

(a)
confirm the initial decision; or
(b)
revoke the initial decision, or revoke that decision and make a decision in substitution for the initial decision.

...
(6)
Where written notice of the making of an initial decision is given to a person whose interests are affected by the decision, the notice is to include a statement to the effect that a person whose interests are affected by the decision may:

(a)
seek a reconsideration of the decision under this section; and
(b)
subject to the Administrative Appeals Tribunal Act 1975, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Appeals Tribunal for review of that decision.

The initial decision to register Alphapharm's product was made under Pt 3 of the Act.

On 8 June 1993 , the solicitor wrote to the Minister for Family Services as follows:

We act for SmithKline Beecham Laboratories (Australia) Ltd (formerly called Smith Kline & French Laboratories (Australia) Ltd), which company markets cimetidine in Australia under licence from the patent holder, Smith Kline & French Laboratories Ltd of the United Kingdom.
On 11 March 1993 Mr Paul Pirani, the assistant secretary of the Legal Services Branch of the Department of Health, Housing and Community Services, informed us that the Alphapharm brand of cimetidine was placed on the Therapeutic Goods Register on 18 February 1993 .
Our client's interests are affected by the decisions to allow Alphapharm's cimetidine to be placed on the Therapeutic Goods Register and accordingly, on behalf of our client we request you, pursuant to s 60(2) of the Therapeutic Goods Act 1989, to reconsider that decision.
We made a similar request of Senator Richardson on 1 June 1993 but have since been informed that you are the responsible minister.
Since tomorrow is the last day for making a request for reconsideration, we are writing to you in these terms so as to avoid any future controversy as to whether the request was made to the responsible minister within time.

A letter from the Department of Health, Housing and Community Services to the solicitor dated 16 June 1993 responded as follows:

Thank you for your letter of 8 June 1993 seeking to appeal under s 60 of the Therapeutic Goods Act 1989 (the Act) against the decision (the initial decision) to approve registration of the brand of cimetidine sponsored by Alpbapharm Pty Ltd (Ulcidine 200, 400 and 800: "the products"). The initial decision was made on 15 January 1993 by Dr B Hillcoat, as delegate of the Secretary.
Your letter has been referred to me for attention.
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 .)

Proceedings under the Administrative Decisions (Judicial Review) Act 1977 (Cth) (the ADJR Act) were then instituted in the Federal Court, the applicant being named as SmithKline Beecham Laboratories (Australia) Ltd. Before the matter came on for hearing, it came to the solicitor's attention that SmithKline Laboratories had been struck off the register in Australia. Notice of the striking off dated 12 February 1993 was published in the Commonwealth of Australia Gazette on 3 March 1993 .

In an affidavit filed in the court, the solicitor deposed as follows:

3.
From early 1987 to date I have had instructions to act in certain proceedings for the SmithKline company carrying on the business of compounding and marketing cimetidine in Australia.
4.
On or about 15 October 1991 I received instructions to write the letters marked "A1" and "A2" annexed to my affidavit of 28 June 1993 . When I sent those letters to the Department of Health, Housing, Local Government and Community Services (the department) and the Secretary of the Australian Drug Evaluation Committee, I was intending to write on behalf of the company in Australia which had governmental approvals to market cimetidine in Australia and other companies in the SmithKline group whose confidential information had been disclosed to the department ...
5.
In or about May 1992 I became aware that the name of Smith Kline & French Laboratories (Australia) Ltd had changed to SmithKline Beecham Laboratories (Australia) Ltd ...
6.
In or about June 1992 while preparing further affidavits for use in the cimetidine patent extension proceedings, I also became aware that in July 1991 SmitKline Beecham Laboratories (Australia) Ltd sold its assets to SmithKline Beecham (Australia) Pty Ltd, which company as a consequence took over the activities previously conducted by SmithKline Beecham Laboratories (Australia) Ltd. This information subsequently slipped my mind as described below.
7.
On or about 8 June 1993 I received instructions to send the letter which is annexure "D" to my affidavit of 28 June 1993 . When I sent that letter I intended to act on behalf of the SmithKline company which marketed cimetidine in Australia and I knew that my instructions were to write on behalf of that company. In writing the letter, I remembered the name change, but forgot the asset transfer described in para 6 above.
8.
On or about 28 July 1993 I received instructions to commence these proceedings. When I commenced these proceedings, I intended to act on behalf of the SmithKline company which marketed cimetidine in Australia and I knew that my instructions were to act on behalf of that company. In commencing the proceedings, I remembered the name change but forgot the asset transfer described in para 6 above.

It appears therefore that, when the solicitor wrote to the minister on 8 June 1993 , and when he instituted proceedings in this court in the name of SmithKline Laboratories, that company had been struck off the register in Australia, though it still existed in some form in other parts of the world. The solicitor did, however, have instructions and his instructions came at the relevant time from SmithKline.

I shall take the issues in reverse order to those that I have set out above.

The trial judge treated the issue of the name of the applicant in the proceedings in the court as one of misnomer and ordered that the name of Smith Kline be substituted for that of SmithKline Laboratories. In this appeal, counsel for Alphapharm submitted that it was not a case of misnomer and that her Honour had incorrectly substituted SmithKline as the applicant when no extension of time had been granted under s 11 of the ADJR Act to enable SmithKline, as distinct from SmithKline Laboratories, to institute the proceedings out of time.

I do not propose to discuss this issue. Her Honour's order was an interlocutory order and leave to appeal from it should be refused. Obviously, SmithKline was a proper party to the proceedings before her Honour and, if an extension of time was required, that was a procedural problem which the needs of justice would require to be remedied. There is no substance behind the point.

The next issue, that as to whether an application for reconsideration was lodged by SmithKline on 8 June 1993 , appears to me to be a matter which in the first instance is one for the primary decision-maker, the minister.

Counsel for Alphapharm submitted that, as a matter of law, the solicitor did not make an application on behalf of SmithKline. Counsel referred to several cases which have been considered the institution of legal proceedings in the wrong name, cases in which the point has had significance because of a statute of limitation: see Weldon v Neal (1887) 19 QBD 394 ; Federated Municipal and Shire Council Employees Union of Australia v Shire of Albany (1990) 32 IR 470 ; Davies v Elsby Bros Ltd [1960] 3 All ER 672 .

The trial judge treated the question as one of misnomer because the reference to SmithKline Beecham Laboratonies (Australia) Ltd was followed by the inconsistent description, "which company markets cimetidine in Australia under licence from the patent holder". There is no suggestion in the material before the court or in the context of the litigation over confidential information that the Department of Health, Housing and Community Services or the minister was in the least concerned with the precise name of the company which was marketing cimetidine in Australia under licence from the patent holder. Indeed, two letters from officers of the department to the solicitor dated 23 October 1991 and 11 March 1993 do not even mention the name of the solicitor's client. Although the letter refusing reconsideration dated 16 June 1993 referred specifically to SmithKline Laboratories, the letter was not written on the basis that SmithKline Laboratories, having sold out to SmithKline, then had no interest whatever in the matter. The letter was written on the basis that the applicant seeking reconsideration had competing commercial interests which were not relevant interests for the purposes of the Act.

I agree with the trial judge that the misnomer by the solicitor appears to be no cause not to grant a mandatory order if the solicitor's client, SmithKline, had relevant interests which were affected by the initial decision: see the discussion of misnomer in Bainbridge-Hawker v Minister for Trade and Customs (1958) 99 CLR 521 at 532 -5; Federated Municipal and Shire Council Employees Union of Australia v Shire of Albany (1990) 32 IR 470 at 473 . Nevertheless, I am of the opinion that the question whether SmithKline made an application within the specified period of 90 days is one which, in the first instance, is for the primary decision- maker to consider and to rule upon.

I therefore turn to the principal point of the appeal, whether interests were relevantly affected by the registration of Alphapharm's generic cimetidine so as to entitle it to lodge a request under s 60(2) of the Act that the minister reconsider the decision.

The letter of 8 June 1993 gave only one indication as to the nature of the interest relied upon and that was that the company marketed cimetidine in Australia. The officer who wrote the letter refusing reconsideration stated: "In referring to your client's interest, I assume you mean your client's commercial interest."This letter impliedly requested the company to respond if the fact was that other than commercial interests were involved. There was no response.

In the proceedings in the court, an affidavit sworn by the solicitor included the following paragraphs:

8.
Registration of its cimetidine product under the Therapeutic Goods Act 1989 is a necessary prerequisite for Alphapharm to be able lawfully to import cimetidine into Australia and to supply cimetidine to the Australian market.
9.
The entry of Alphapharm's cimetidine to the Australian market consequent upon the decision of which the applicant seeks the minister's reconsideration is likely to reduce the applicant's market share and affect the price for cimetidine the applicant will be able to secure, with consequent adverse impact upon its profits in Australia.
...
18.
Should the relief sought in the present proceedings be granted, the minister will be required to reconsider the initial decision to approve registration of the Alphapharm cimetidine. Upon such reconsideration, review by the Administrative Appeals Tribunal is available. It is of great importance to the applicant that all doubts as to the validity of the initial decision and any ministerial reconsideration be resolved prior to the expiry of the cimetidine patent on 15 February 1994 since Alphapharm may be expected to introduce its cimetidine into the Australian market after that date and may commence soliciting orders (at prices lower than those of the applicant) beforehand. For this reason the applicant seeks expedition of these proceedings.

It is clear from this affidavit that the interest which SmithKline was propounding was that Alphapharm's generic cimetidine, if allowed onto the market, would compete with SmithKline's cimetidine with the consequence that prices would be reduced and that SmithKline's profits in Australia would suffer.

To his affidavit, the solicitor annexed certain paragraphs of an affidavit of Dr John McEwen, which had been filed on behalf of the Department of Health, Housing and Community Services in proceedings G561 of 1987, and an affidavit of Daniel John Evans, which had also been filed in those proceedings. These affidavits discussed problems relating to the testing and evaluation of goods such as cimetidine and generic cimetidine. The solicitor did not depose to any specific interest which SmithKline had in that regard.

The letter from the solicitor to the Secretary, Department of Health, Housing and Community Services dated 15 October 1991 which, inter alia, put the department on notice that the solicitor's clients may seek to challenge any decision of the Secretary of the department to grant Alphapharm's applications, was put in evidence. Also put before the trial judge was the letter to the Secretary of the Australian Drug Evaluation Committee of 15 October 1991 and a letter to the solicitor from the Department of Health, Housing and Community Services dated 23 October 1991 which responded to those letters. Those letters were said by counsel for SmithKline to reflect an interest which SmithKline had in the quality, safety efficacy of Alphapharm's product. However, no person has deposed to that fact on behalf of SmithKline. The letters from the solicitor read as if they were written for the purpose of laying the groundwork for a challenge to the decision when made.

In this appeal, counsel for SmithKline submitted that SmithKline had an interest in ensuring that Alphapham's product was a safe and suitable drug for human use. He submitted that, if it turned out that Alphapham's generic cimetidine was placed on the market and was unsafe, that fact would be likely to reflect adversely upon SmithKline's cimetidine. However, there is no affidavit material supporting this contention. One cannot determine issues of this kind on the basis of mere assertions from the bar.

The general principles covering standing, including the phrase "interests are affected", have been considered in numerous cases, many of which were referred to by a Full Court of this court in US Tobacco Co v Minister for Consumer Affairs (1988) 20 FCR 520 at 526 -30; 83 ALR 79 . The person whose interests are affected must have an interest other than that which attaches to members of the general public and other than that of a person merely holding a belief that a particular type of conduct should be prevented or a particular law observed. The adjectives "real", "genuine" and "direct" have been used to describe the relationship required. The term "interests are affected" does not make use of an adjective, but it requires that the applicant demonstrate genuine affection of an interest which attaches to him.

Relevant proprietary and financial interests have traditionally been considered to be sufficient: see eg Tooheys Ltd v Minister for Business and Consumer Affairs (1981) 36 ALR 64 ; Broadbridge v Stammers (1987) 16 FCR 296 ; 76 ALR 339 ; New South Wales Fish Authority v Phillips [1970] 1 NSWR 725 ; Association of Data Processing Service Organisations v Camp (1969) 397 US 150 . Indeed, in recent years, most attention has been given to those circumstances in which persons without any proprietary or commercial or tangible interest have, nevertheless, been thought to have standing to take part in the administrative process or in legal proceedings: see eg Sinclair v Mining Warden at Maryborough (1975) 132 CLR 473 ; 5 ALR 513 ; Australian Conservation Foundation; Onus v Alcoa (1981) 149 CLR 27 ; 36 ALR 425 ; Ogle v Strickland (1987) 13 FCR 306 ; 71 ALR 41 ; the US Tobacco case; Telecasters North Queensland Ltd v Australian Broadcasting Tribunal (1988) 82 ALR 90 , Australian Conservation Foundation v Minister for Resources (1989) 19 ALD 70 and Cameron v Human Rights and Equal Opportunity Commission (1993) 119 ALR 279 .

The question can be complex and this has led some judges to discourage parties from taking a point as to locus standi as a preliminary issue: see eg the remarks of Lord Scarman in Inland Revenue Commission v National Federation of Self-Employed and Small Business Ltd [1982] AC 617 at 649. In the same case at 630, Lord Wilberforce pointed out that, in some cases, the question of sufficient interest cannot be considered in the abstract or as an isolated point; it must be taken together with the legal and factual context.

One relevant factor is the extent of the affection of the person's interests. In Re McHattan and Collector of Customs (NSW) (1977) 18 ALR 154 at 157 ; 1 ALD 67 at 70 , Brennan J pointed out that: "Across the pool of sundry interest, the ripples of affection may widely extend." But his Honour did not propose that any ripple of affection would be sufficient to support an interest. In McHattan's case, Brennan J dismissed the application, there being no interests of Mr McHattan which were immediately and directly affected. His Honour rejected the view that the challenged decision might have affected Mr McHattan's reputation, holding that the challenged decision would affect reputation only "in a most tenuous way". In Australian Foreman Stevedores' Association v Crone (1988) 20 FCR 377 ; 98 ALR 276 , Pincus J said at FCR 382; ALR 281:

A decision favourable to one citizen may affect many others: some directly, and some more remotely. There is a point, which must be fixed as a matter of judgment in each case, beyond which the court must hold that the interests of those affected are too indirectly affected to be recognised.

His Honour rejected the application on the ground that the decisions sought to be attacked were not shown to affect any of the applicants' interests significantly, nor would success in the litigation be likely to give them a benefit or advantage of any consequence.

It appears from K C Davis' Administrative Law Treatise (2nd ed, 1983), para 24:17, that the extent of the affection may be the true guide for standing in judicial review proceedings in the United States. Davis tends to reject a test based on "the zone of interests to be protected or regulated by the statute", a test which was enunciated in Association of Data Processing Service Organisations v Camp (1970) 397 US 150 and Barlow v Collins (1970) 397 US 159 . However, such a test may be relevant under the law of the United Kingdom and of this country. In US Tobacco at FCR 529; ALR 89, the court said:

"The nature of the interest required in a particular case will be influenced by the subject matter and content of the decision under review."

This must be so with respect to the phrase "interests are affected", when used in a statute which provides for the administrative review of an administrative decision. 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.

The question of standing is, indeed, related to issues of procedural fairness. If a person has interests which ought to be taken into account in the making of a decision, then ordinarily that person should be entitled to be heard. Mason CJ expressed the principle of natural justice in these terms in Kioa v West (1985) 159 CLR 550 at 584 ; 62 ALR 321 at 346 :

The law has now developed to a point where it may be accepted that there is a common law duty to act fairly, in the sense of according procedural fairness, in the making of administrative decisions which affect rights, interests and legitimate expectations, subject only to the clear manifestation of a contrary statutory intention
...

Many such decisions do not affect the rights, interests and expectations of the individual citizen in a direct and immediate way. Thus a decision to impose a rate or a decision to impose a general charge for services rendered to ratepayers, each of which indirectly affects the rights, interests or expectations of citizens genenally, does not attract this duty to act fairly. This is because the act or decision which attracts the duty is an act or decision:

"... which directly affects the person (or corporation) individually and not simply as a member of the public or a class of the public. An executive or administrative decision of the latter kind is truly a "policy" or "political" decision and is not subject to judicial review." (Salemi (No 2) (1977) 137 CLR 396 at 452 ; 14 ALR 1 at 45 , per Jacobs J).

Thus, in cases such as Bray v Faber [1978] 1 NSWLR 335 , it has been held that, when a person did not have a right to be heard during the decision-making process, so also the person did not have a right to seek a declaration that the decision was void. On the other hand, in cases such as R v Hendon Rural District Council; Ex parte Chorley [1933] 2 KB 696 ; R v Richmond Confirming Authority; Ex parte Howitt [1921] 1 KB 248 , where the person had a right to be heard in the making of the decision, it was held that that person had a right if aggrieved by the decision to seek judicial review of it.

Such a factor weighed with the court in Sinclar v Mining Warden at Maryborough. In US Tobacco, the participation of the Australian Federation of Consumer Organisations in the administrative decision- making process and its entitlement to attend a conference arranged by the minister was held to place the organisation in a special position which gave it standing. In Telecasters North Queensland Ltd v Australian Broadcasting Tribunal, an organisation which had not in fact participated in a public inquiry was nevertheless held to be an interested party in judicial review proceedings as it had been the initiator of the inquiry, and had been entitled to participate therein. A like case is Australian Conservation Foundation v Forestry Commission (1988) 19 FCR 127 ; 79 ALR 685 . In Mark v Australian Broadcasting Tribunal (1991) 32 FCR 476 ; 108 ALR 209 , standing was refused on the ground that, although the applicant had initiated administrative proceedings under the Broadcasting Act 1942 (Cth), he ought not to have done so and had no interest therein.

The Act recognises that persons other than the sponsor may have interests which may be taken into account in the making of the decision. Section 60(6) recognises that notice of the original decision may be given not only to the applicant but to other persons whose interests may be affected. Persons having an interest in the registration of a particular drug may include the owners of a relevant patented process, assignees and licensees of the patent, manufacturers and distributors of the drug, persons who have a medical condition which the drug, if registered, may alleviate and organisations representing an element of the public interest which wish to put a view as to the use or the testing or evaluation of the drug. These are all persons who, in a particular case, might be expected to participate in the decision-making process. In Re Welborn and Department of Health, Housing and Community Services (1993) 18 AAR 198 , the Administrative Appeals Tribunal held that a leading endocrinologist who prescribed a drug to treat patients with diabetic neuropathy had standing to seek review of a decision refusing to register the drug under the Act.

However, the Act makes no provision for the joinder of persons in the decision-making process. There is certainly no provision for the hearing of competitors who may suffer financial loss if the drug be marketed. Applications for registration and for listing are not advertised. There is no provision for the hearing of witnesses or for the hearing of any interested parties. The procedure of investigation, testing and evaluation is undertaken by experts in the field. And that process is confidential, as the litigation in the Smith Kline & French cases sufficiently demonstrates.

The Act is dominated by public interest concerns. An object is to ensure that drugs which are imported are suitable for use in humans in Australia. Another object is to ensure that drugs which are suitable are registered or listed and become available in Australia for public use as soon as is practicable: see ss 4 and 17 of the Act. The regulations specify times within which certain evaluations must be made and certain applications decided, and a remedy in the nature of damages is provided for failure to make certain decisions within the specified time. And, as I have pointed out, the Act and the regulations set up a structure, including the Australian Drug Evaluation Committee, for the carrying out of the necessary inquiries and for the making of skilled judgments as to the suitability or otherwise of a drug.

In this context, it is difficult to see that the Act would recognise the interest which a competitor may have in delaying or hindering the introduction of the drug onto the market. Such an interest is not relevant to the process which the Act establishes or to any decision made under the Act. Such an interest is indeed in conflict with the interests which the Act promotes.

If a decision concerns the affairs of one person alone, other persons may not institute or join in the proceedings merely because it would be to their commercial advantage that the person should not receive a benefit or should suffer a disadvantage. Thus, in respect of those decisions under the Customs Act 1901 (Cth) which affect a wide group of persons having differing interests, eg commercial tariff concession orders and anti-dumping decisions, the Customs Act makes provision for the advertising of an application and for inquiries to be made in the industry. In Irish Country Bacon (Cooked Meats) Ltd v Comptroller- General of Customs (1991) 32 FCR 355 ; 104 ALR 661 , Foster J recognised the interest of an Australian manufacturer of bacon to join in judicial review proceedings with respect to a decision to impose dumping securities, though in the exercise of his discretion his Honour refused joinder save on a limited basis.

On the other hand, an issue such as the value of goods for customs purposes is considered to be a matter relating only to the importer and to persons related to the importer. The only person who may seek administrative or judicial review is the person who has paid the duty under protest. In Re Pilkington ACI Ltd and Collector of Customs (1985) 7 ALD 689 , an unsuccessful attempt was made to overcome this restriction. Pilkington ACI, an Australian manufacturer of toughened glass, considered that competing glass imported by others from overseas was being imported at too low a duty. Pilkington ACI wished to challenge the duty. Being unable to do so directly, it imported toughened glass from overseas and, when it paid the duty, it did so under protest alleging that the duty demanded was too low. The Administrative Appeals Tribunal refused to consider the application, holding that, as the Collector of Customs had not demanded more than Pilkington ACI was willing to pay, there was no relevant dispute between the parties. In a like field, Lord Wilberforce said in Inland Revenue Commissioner v National Federation of Self-Employed and Small Businesses Ltd at 633:

As a matter of general principle I would hold that one taxpayer has no sufficient interest in asking the court to investigate the tax affairs of another taxpayer or to complain that the latter has been under-assessed or over-assessed: indeed, there is a strong public interest that he should not.

In the case of the decision as to generic cimetidine, SmithKline's interests as outlined in the letter of 8 June 1993 and in the solicitor's affidavit were entirely irrelevant. The issue before the decision-maker was the safety of the drug and the appropriateness of its use in humans. Some elements of commerce may have intruded into the decision for, no doubt, the decision-maker would have wished to be satisfied that the manufacturer of the drug was reputable and had the capacity to ensure quality control. But the affairs of SmithKline were irrelevant, though information related to its cimetidine may have been taken into account. The decision did not concern itself with any of SmithKline's affairs and was not a decision relating to SmithKline's cimetidine.

In R v Commissioners of Customs and Excise (DC) [1970] 1 WLR 450 , Lord Parker CJ, with whom Willis and Bridge JJ agreed, held at 456 that an applicant for an order of mandamus did not have a relevant interest on the ground that, "... the interest, or the motive, which is moving in this application is what I would term an ulterior motive, a motive of putting people out of business and nothing more". His Lordship was pointing to the fact that the application was made simply with a view to reducing competition, which was not a matter relevant to the decision or action of the Commissioners of Customs and Excise. That decision was referred to in Re Rothmans of Pall Mall Canada Ltd v Minister of National Revenue (1976) 67 DLR (3d) 505 in which it was held that certain cigarette manufacturers did not have standing to seek an order prohibiting the Department of National Revenue from exempting from increased excise duty certain cigarettes manufactured by competitors. At 513, Le Dain J, delivering the judgment of the court, said:

A person should not, however, in my view, have the right to interfere with or meddle in official action affecting an existing competitor for the sole purpose of preventing the competitor from obtaining some advantage, particularly where the action complained of is something that the person complaining is free to take advantage of himself.

To the same effect and almost directly in point to the present case is the decision of Rouleau J in Re Glaxo Canada Inc and Minister of National Health and Welfare (1987) 43 DLR (4th) 273. In that case, a drug company, Glaxo Canada Inc, sought an order, inter alia, restraining the Minister of National Health and Welfare from giving effect to a notice of compliance issued to Apotex Inc which had lodged a submission for the sale and advertising of the drug Ranitidine. At 281, Rouleau J said:

The sole motive on the plaintiff's part in bringing this application appears to me to be to prevent competition in a market where it has, up to the date of the minister issuing a notice of compliance to the defendant Apotex Inc, enjoyed a virtual monopoly. I agree with the defendants that such a concern on the part of the plaintiff does not translate into a legal right or interest sufficient to bestow on the plaintiff standing to bring the present action.

And at 284:

As previously stated, the plaintiff has no genuine interest in any issue raised in this case other than a purely competitive or economic interest.

It is interesting to note that, at 288, Rouleau J rejected a ground of interest put forward in the present case, namely the suggestion that the minister must have wrongfully used the plaintiff's confidential data. Rouleau J said:

With respect to the plaintiff's assertion that the minister must have wrongfully utilised the plaintiff's data in processing the defendant Apotex' new drug submission, the plaintiff's evidence again amounts, in my opinion, to nothing but sheer speculation without any direct and probative evidentiary value.

For like reasons, in my opinion, on the material before the court, SmithKline has not demonstrated that it had a relevant interest entitling it to request reconsideration of the initial decision. The interest which SmitKline has propounded - that of a competitor whose interests would be affected as the drug, if it were registered and placed on the market, would compete with cimetidine and reduce its price - is not an interest which the Act recognises for the purposes of s 60(2).

I should add that, if SmithKline had shown a relevant interest, I would not have held it to be disentitled by the fact that the drug had been registered. In my opinion, a decision for the purpose of s 60 encompasses both registration and refusal to register.

Section 60(1) of the Act defines "decision" as having the meaning in the Administrative Appeals Tribunal Act. Section 3(1) of that Act includes both the making of "an order or determination" and the refusal to do so. Section 41 of the Administrative Appeals Tribunal Act confers power on the tribunal to suspend a decision (as to which see Yolbir v Administrative Appeals Tribunal and Secretary, Department of Social Security (Davies, Burchett and O'Connor JJ, 15 February 1994 , unreported) and s 43 confers power to set it aside. The provision for cancellation under s 30 of the Act does not affect the operation of those provisions.

The trial judge did not determine the question of standing but held that there was an error of law in that the letter of 16 June 1993 included the statement that: "Your client is seeking to use the review process provided under s 60 for commercial purposes rather than for those purposes outlined in the scheme of the legislation."Her Honour remitted the matter for redetermination according to law. In my opinion, however, the letter of refusal to reconsider put the substance of the matter which I have attempted to explain at greater length in these reasons. The writer of the letter-took the view that the company's commercial interests were not relevant to the decision-making process and, as they were the interests relied upon, the company was not a person with interests which were affected. I agree with the substance of that view. On the material before the court, no case has been shown for either a mandatory order or for remitting that matter for reconsideration.

I would allow the appeal and would set aside orders (2) and (3) of the Orders made by the trial judge. I would substitute therefor an order that the application to the court be dismissed with costs. I would order that SmitKline Beecham (Australia) Pty Ltd pay the costs of the appeals.


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