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

(1994) 49 FCR 250

---

(Judgment by: Gummow J) Court:

Judges: Davies J
Burchett J

Gummow J

Judgment date: 31 March 1994

Sydney

---

Judgment by:
Gummow J

These appeals were heard together. Each is brought from the decision of a judge of this court (reported (1993) 118, ALR 617) upon an application for an order of review under the Administrative Decisions (Judicial Review) Act 1977 (Cth) (the ADJR Act). The third respondent in appeal No G910 and the appellant in appeal No G917 (the minister) is the minister responsible for the administration of the Therapeutic Goods Act 1989 (Cth) (the Act).

Beazley J granted an order of review of the decision of the minister to refuse to reconsider, under s 60(3) of the Act, an initial decision made under Pt 3 of the Act to approve the registration thereunder of a brand of cimetidine sponsored by Alphapharm Pty Ltd (Alphapharm). Alphapharm is the appellant in appeal No G910 and second respondent in appeal No G917.

The cimetidine litigation

Registration of its cimetidine product under Pt 3 of the Act is a necessary prerequisite for Alphapharm lawfully to import cimetidine into Australia and to supply it to the Australian market. Cimetidine is a compound which falls within certain claims of Australian letters patent No 460,353 (the patent) which was granted on 7 April 1975 under the provisions of the Patents Act 1952 (Cth). Put broadly, cimetidine has a valuable therapeutic use in blocking histamine receptors and thereby inhibiting the secretion of acid in the stomach. It has been a major advance in the treatment of peptic ulcers and related disorders. The term of the patent commenced 15 February 1972 , and a petition to the Supreme Court of New South Wales for the extension of the term of the patent was successful. In the result, by order made 14 December 1992 , the term was extended to 15 February 1994 .

The grantee of the patent was Smith Kline & French Laboratories Ltd, a company incorporated in England. Cimetidine has been marketed in Australia under licence from the patentee by a related corporation, Smith Kline & French Laboratories (Australia) Ltd. That company changed its name to SmithKline Beecham Laboratories (Australia) Ltd (SK Laboratories) which, in turn, in July 1991 sold its assets to another related corporation, SmithKline Beecham (Australia) Pty Ltd (SK Australia). SK Australia is the first respondent to both appeals. SK Laboratories is incorporated in England and was registered in this country as a foreign company (overseas). It is the second respondent in appeal No G910. In the proceeding below it was named as the applicant. I will refer to these and related corporations collectively as "the SK Group".

Whilst the patent remained in force, only the patentee or licensees were entitled to supply cimetidine to the Australian market. With the expiry of the extended term of the patent that barrier to the entry into the Australian market of Alphapharm would be removed. However, for Alphapharm to obtain its objective it would also be necessary for it to comply with the therapeutic goods legislation.

This present litigation is a further stage in a dispute between Alphapharm, the regulatory authorities and the SK Group which has already been before this court. In order to appreciate the issues on this appeal it is necessary to have regard to that dispute.

Alphapharm markets so-called "generic" pharmaceutical products, a term used in contradistinction to innovator" products. The SK Group comprises innovators in the sense that patent protection was obtained as a reward for their research and development work. On 14 July 1988 , Alphapharm sought general marketing approval for a generic brand of cimetidine. It applied under the therapeutic goods legislation then in force. A dispute ensued as to whether the regulatory authorities were at liberty to use, for the process of considering the application of Alphapharm, information supplied, but not for that purpose, by the SK Group. The SK Group was unsuccessful in this court, both at first instance ( 22 FCR 73 ) and in the Full Court ( 28 FCR 291 ). On 29 August 1991 , the High Court dismissed an application for special leave to appeal against the decision of the Full Court.

The current dispute

In the meantime, there had been a change in the structure of the therapeutic goods regulatory system and the Act had come into force on 15 February 1991 . On 15 October 1991 , Minter Ellison, solicitors for the SmithKline companies, wrote to the Secretary of what was then the Department of Health, Housing and Community Services, seeking an undertaking from the Secretary that he would advise the firm in writing immediately of each decision made in respect of the Alphapharm marketing applications so that the clients of the firm might then consider whether or not they wished to take steps to challenge the decision. A letter also was sent to the Secretary of the Australian Drug Evaluation Committee (ADEC). In the response dated 23 October 1991 , from an Assistant Secretary in the Legal Services Branch of the department, the point was made:

Normally rival drug companies were not advised of the granting of marketing approval because to provide such details would have enabled marketing strategies to be implemented to the detriment of an applicant drug company. Such information was previously regarded as confidential by this department.

After referring to the changed situation following the introduction of the Act, the writer continued:

I am advised that it is normal practice for a product to be included on the register within, at most, a week of the approval being granted under s 25 of the Act. This being the case I am prepared, in this instance, to treat your letter as a standing request under s 61(6) of the Act so that you will be advised as soon as the Alphapharm brand of cimetidine has been listed on the register. I note, however, that while I am prepared to do this in this instance, my decision is based on the unusual nature of the events that have occurred since April 1987 concerning cimetidine and should not be regarded as any form of precedent for the acceptance of future requests as standing requests for information pursuant to the above provision.

In the letter of 15 October 1991 to the Secretary of the ADEC, the solicitors had said that their clients did not know which polymorphic form of cimetidine Alphapharm proposed to market, but that, if the Alphapharm cimetidine was of a different composition to the SK Group product, the sale and efficacy of the latter over the years would provide no assurance of the safety and efficacy of the Alphapharm product. An assurance was sought that any evaluation which ADEC conducted of the Alphapharm product would be on the basis that it was satisfied that if the polymorphic form differed from that of the Smith Kline & French product, a full testing procedure had been conducted to establish the safety and efficacy of the Alphapharm product.

In the letter from the Legal Services Branch of 23 October 1991 , to which I have referred, the writer referred to certain paragraphs in an affidavit sworn in the Federal Court proceeding by a senior officer of the department, Dr John McEwen. The letter continued:

As is clearly set out in the above paragraphs, the question of polymorphism is of relevance to determining the public safety of a product and is a matter which is considered by a drug evaluator ... I can advise you that the issue of the polymorphic form of the Alphapharm product will be considered in the evaluation of the Alphapharm application.

By letter dated 11 March 1993 , the solicitors were informed that the generic cimetidine to be marketed by Alphapbarm had been placed on the register under the Act on 18 February 1993 . A request for a reconsideration of the decision under s 60(2) of the Act was made on 8 June 1993 . The solicitors there said:

Our client's interests are affected by the decision 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.

The response, by letter to the solicitors dated 16 June 1993 , was that there was a lack of sufficient standing to bring an application for a review under s 60 of the Act. The letter stated that the writer assumed that the reference to "our client's interests" had been to its commercial interests and continued:

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.

I agree with Burchett J that the reference to commercial purposes was made to demonstrate or emphasise lack of standing.

The application for an order of review was filed in this court on 29 July 1993 . The primary judge granted leave to amend the application by substituting SK Australia for SK Laboratories as the applicant. This change reflected the circumstance that the latter corporation had been deregistered here in this country on 3 March 1993 , and that its assets previously had been sold to SK Australia. Secondly, the primary judge ordered that the minister reconsider in accordance with law the application made 8 June 1993 .

In appeal No G910 of 1993, Alphapharm appeals against the orders so made. In appeal No G917, the minister appeals against the second but not the first order. An appeal against the first order requires leave because that order is interlocutary in characcter. In argument before us, this was accepted to be so. The court reserved the question as to whether leave should be granted and heard full argument on the matter.

Section 60 of the Act

It is appropriate now to turn to the Act. The central provision upon which this litigation turns is s 60. It states:

(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.

(4)

Where a person who has made a request under subsection (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.

(5)

After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 28(4) of the Administrative Appeals Tribunal Act 1975 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Appeals Tribunal for review of that 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.

(7)

Any failure to comply with the requirements of subsection (5) or (6) in relation to a decision does not affect the validity of the decision.

(8)

An application may be made to the Administrative Appeals Tribunal for review of a reviewable decision.

The effect of s 60(8) of the Act is to attract the operation of s 27(1) of the Administrative Appeals Tribunal Act 1975 (Cth) (the AAT Act). Section 27(1) of the AAT Act provides:

(1)

Where this Act or any other enactment provides that an application may be made to the Tribunal for a review of a decision, the application may be made by or on behalf of any person or persons (including the Commonwealth or an authority of the Commonwealth) whose interests are affected by the decision.

The phrase "a person whose interests are affected by a decision" thus is of significance at two stages of the operation of s 60 of the Act. The first is to identify those who, under s 60(2) of the Act, may request the minister to reconsider an "initial decision". Where the minister does go ahead to reconsider the initial decision and as a result makes a "reviewable decision" under s 60(3), an application may then be made to the tribunal (the AAT) for review thereof, provided the applicant for that review was one whose interests were affected by the reviewable decision.

What happened in this case did not involve any review on the merits under the AAT Act. That state was not reached. The minister did not give any decision reviewable by the AAT. Rather, the view was taken that there was a lack of sufficient standing because the party requesting reconsideration of the initial decision was not a party whose interests were affected by it, within the meaning of s 60(2).

The application for an order of review under the ADJR Act was treated as made in respect of a refusal to reconsider the initial decision pursuant to s 60(3) of the Act. Such a refusal may itself amount to the making of a decision for the purposes of the ADJR Act; see s 3(2). That in turn attracts the operation of s 5 of the ADJR Act. The question in issue before the primary judge was whether the decision-maker had made an error of law in deciding that the applicant lacked sufficient standing to request reconsideration by the minister of the initial decision to approve the registration of the brand of cimetidine sponsored by Alphapharm.

Before the primary judge there was evidence that the entry of Alphapharm cimetidine into the Australian market consequent upon the initial decision would be likely to reduce the market share of the SK Group product and affect the price for cimetidine which the applicant would be able to secure, with consequent adverse impact upon profits in Australia. Her Honour held ( 118 ALR 617 at 631 ):

... this commercial interest is ... not a sufficient interest for the purposes of the Act. There is nothing in the purpose and scope of the Act which relates to market share, price or profit.

Her Honour also held that whilst it was unnecessary to deal with the point, there was merit in the submission that it was not open to a decision-maker to assume that, by the mere registration of the drug, a competitor such as the applicant would suffer a pecuniary detriment or had any other interest which was affected. She referred to the decision of Brennan J in Re McHattan and Collector of Customs (1977) 18 ALR 154 at 157 . His Honour, speaking of the phrase in s 27(1) of the AAT Act "any person or persons ... whose interests are affected by the decision", had drawn a distinction of importance for the present litigation. The case before Brennan J concerned a decision being a demand for payment made by the Collector of Customs. His Honour said:

The interest of which s 27(1) speaks is an interest which is affected by the decision to be reviewed, not by the review. The outcome or possible outcome of the proceedings is not the criterion for determining whether the proceedings have been duly instituted, and the relevant interest must be one which is affected by the demand whatever the outcome of a review might be.

It followed that it was not material in the case before Brennan J to inquire as to the possible consequences of a successful application to review the decision of the Collector to make the demand.

However, in the present case, the primary judge went on to find for the applicant on a further ground which she expressed as follows (118 ALR at 633):

It is clear ... that as early as 15 October 1991 , SmithKline Laboratories had indicated that it might challenge any decision to register the [Alphapharm] product, and the bases upon which it intended to do so. Those bases included safety issues and the efficacy of the [Alphapharm] product. The issues had also been raised, amongst other issues, in the affidavit evidence in the proceedings in the Federal Court to which I have referred. Whether these concerns, as to the safety and efficacy of the product, are well based is not in issue here. Nor is it important that the purpose or motive in expressing and seeking to ventilate such concerns may have been to protect [Alphapharm's] commercial interests. The concerns were directly related to the "quality", "safety" and "efficacy" of the [Alphapharm] product. Each of those matters is expressly within the stated object of the Act: see s 4.

For myself, I would doubt whether there is any clear distinction between the two grounds upon which the issue of standing was decided by the primary judge. The SK Group, the innovator of cimetidine, was interested in the quality, safety and efficacy of the Alphapharm product for which registration was sought; if it was defective so that there should be a negative evaluation this would, at least for a time, deny entry to a competitor.

The primary issue on the appeal is whether the primary judge erred in her conclusions as to standing for the purposes of s 60(2) of the Act.

Like the expression "a person aggrieved", the phrase "a person whose interests are affected by the decision" and cognate terms, appear in a variety of statutes as the identification of the persons who are given standing to seek administrative or judicial review. The day is long gone when there was any general presumption that in such statutes the "interests" concerned must be proprietary or even legal or equitable in nature, or that the affectation be of a nature as understood in private law. However, it is important not to draw from what was said in any particular decision by way of identification of that which did or did not amount to a sufficient affectation of an interest any general proposition which may be translated to the instant dispute. In each case, the content of the terms "affect" and "interest" are to be seen in the light of the scope and purpose of the particular statute in issue.

For example, in my vew, there is no "general principle" that a decision under an enactment which favours one corporation cannot relevantly affect the interests of a competitor; cf Australian Foreman Stevedores Association v Crone (1989) 20 FCR 377 at 382 -4; 98 ALR 276 . In his reasons for judgment, Davies J refers to decisions under legislation dealing with anti-dumping and commercial tariff concession orders. Another example is provided by the involvement of competitors in a tendering process: Hawker Pacific Pty Ltd v Freeland (1983) 52 ALR 185 at 189 -90; cf Helicopter Utilities Pty Ltd v Australian National Airlines Commission (1961) 80 WN (NSW) 48 .

It is vital to approach the issues on the present appeal upon a review of the scope and purpose of the Act. That this is so is suggested by the very definition of "initial decision" in s 60(1). This identifies a range of decisions of the Secretary under numerous provisions of the Act. First, there are decisions the making of which is authorised by the definition of "therapeutic devices" in s 3(1) and by s 7(1). Then there are refusals to grant a consent under s 14. Finally, there are decisions under Pt 3 or Pt 4 of the Act. The denotation of the phrase "whose interests are affected" as it appears in s 60 should not be assumed to be the same across this spectrum of decision-making. It has a series of distinct operations and, in this sense, is of an ambulatory nature. It should be emphasised that the present appeal is concerned with s 60 in its operation upon initial decisions under s 25 to register.

In some instances there is an obligation upon the Secretary to give to the applicant reasons for the decision. But these are cases where the decision is adverse to the applicant. Examples are found in ss 14(6), 19(4), 25(3) and 38(3).

In some cases the initial decision will not be made upon any application made to the Secretary. The decision may be one which has been made by the Secretary upon his or her own motion. Examples are found in ss 7(2), 28(3) and (3A), 30, 40(2) and 41. The decision may directly affect the existing rights of a party by, for example, the imposition of new conditions upon a registration or licence (ss 28, 40) or by the cancellation of a registration or licence (ss 30, 41). Or, more generally, the Secretary may by order published in the Gazette declare that particular classes of goods are not therapeutic goods for the purposes of the Act (s 7).

Accordingly, it cannot be correct that for the purposes of s 60 of the Act, the class of persons whose interests are affected by an initial decision is limited to disaffected applicants. Persons whose existing situation under the legislation is changed by operatiion of the initial decision, which was not sought but was imposed upon them, must be persons whose interests are affected by the initial decision.

Likewise, when s 60(6) speaks of the giving of written notice of the making of an initial decision to a person whose interests are affected by it, it is clear that those persons will not be limited to unsuccessful applicants seeking rights under the Act.

The Scope and purpose of the Act

Section 4 of the Act states the object of the legislation. It reads:

4.

The object of this Act is to provide, so far as the Constitution permits, for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are:

(a)

used in Australia, whether those goods are produced in Australia or elesewhere; or

(b)

exported from Australia.

Section 15AA of the Acts Interpretation Act 1901 (Cth) has the effect that in the interpretation of a provision of the statute with which this case is concerned, a construction that would promote the purpose or object expressly stated in the statute is to be preferred to a construction that would not promote that purpose or object.

The primary judge stressed that component in the national system referred to in s 4 of the Act which is concerned with the quality, safety and efficacy of therapeutic goods. She did so in a passage which I have set out earlier in these reasons. However, the national system of controls is also to relate to the timely availability of therapeutic goods. An example of the manifestation of a concern with timely availability is found in s 24E. That provision applies where there is an evaluation of therapeutic goods for which an application is made for registration under s 23. In certain circumstances the applicant may elect to have the application treated as having been refused, and thereupon s 60(3) applies as if there has been an initial decision not to register and the minister has, on reconsideration, made a decision under s 60(3) confirming the initial decision. The effect of this is to expedite the availability of an applicatiion to the AAT under s 60(8).

I turn now to other central provisions of the legislation. Part 2 is concerned with standards applicable to therapeutic goods which are imported into Australia or supplied for use in Australia. A standard may be specified by reference to various criteria including a monograph in the British Pharmacopoeia. Part 3 provides for the establishment of the Australian Register of Therapeutic Goods and deals with such matters as applications for registration, evaluation, registration or listing and cancellation thereof. Part 4 establishes a licensing system for the manufacture of therapeutic goods at particular premises in Australia. There are provisions for the application for and granting of licences, and revocation and suspension thereof. Each of the regimes thus established in relation to the fixing of standards, the register and the licensing of manufacture is attended with criminal sanctions in respect of conduct which does not comply with that regime. In Pt 6 (ss 46-63) there are provisions for monitoring compliance with the legislation, including rights of entry to premises. Certain offences, including those in ss 20 and 35, to which I will refer, are indictable offences: s 54.

Part 2 (ss 10-15) is headed "Standards". The minister may, by order published in the Gazette, determine that matters specified in the order constitute a standard for therapeutic goods: s 10. Section 14 provides that except with the consent in writing of the Secretary it is an offence to import therapeutic goods into this country or to supply them for use in Australia if the goods do not conform to the applicable standard; where the Secretary refuses to give consent, then the applicant must be notified in writing of the decisiion and of the reasons therefor.

The secretary has power to declare, by order published in the Gazette, that particular goods or classes of goods are or are not therapeutic goods, and may exercise this power on his or her own motion or following an application in writing: s 7. The term "therapeutic goods" is defined in s 3(1) in such a fashion as to include goods declared to be such by an order in force under s7.

Before turning to Pt 3, I should deal briefly with the provisions of Pt 4: ss 34-43. Put broadly, it is an offence in Australia to manufacture therapeutic goods for supply for use in humans unless there is an exemption or the manufacturer holds a licence which authorises manufacture of the goods at particular premises: s 35. The minister may determine written principles to be observed in such manufacture: s 36. Licences are granted on application: s 37. Where the licence is granted, notice thereof of the decision of the Secretary must be given to the applicant, and where the application is refused there must also be notice of reasons for the refusal: s 38(3). The licence may be granted subject to conditions which may be varied or removed or supplemented: s 40. Licences may be suspended or revoked. In that regard, s 41(2) states:

(2)

Where the Secretary proposes to revoke a licence or suspend a licence otherwise than at the request of the holder of the licence, the Secretary must, unless the Secretary considers that failure to revoke or suspend the licence immediately would create an imminent risk of death, serious illness or serious injury:

(a)

by notice in writing given to the holder, inform the holder of the action that the Secretary proposes to take and of the reasons for that proposed action; and

(b)

except where the proposed action is to be taken as a result of a failure to pay the annual licensing charge or an applicable prescribed inspection fee - give the holder an opportunity to make, within such reasonable time as is specified in the notice, submissions to the Secretary in relation to the proposed action.

(3)

Where the holder makes submissions in accordance with paragraph (2)(b), the Secretary is not to make a decision relating to the revocation or suspension of the licence before taking into account the submissions.

...

(6)

Where the Secretary revokes or suspends a licence, the Secretary must cause particulars of the decision to be published in the Gazette as soon as is practicable after the decision is made.

Part 3 of the Act - Registration and Cancellation

Part 3 (ss 16-33) is headed "Australian Register of Therapeutic Goods". The occasion of this litigation is the decision under Pt 3 favourable to Alphapharm. Section 17 provides for the establishment and maintenance of the Australian Register of Therapeutic Goods. One part relates to registered goods and the other to what are called listed goods. A "sponsor" is defined in s 3(1) in terms which include a person who imports therapeutic goods into Australia or who manufactures them in Australia. It is an offence for a sponsor knowingly or recklessly to import into Australia or to manufacture for supply in Australia therapeutic goods for use in humans, unless those goods are registered goods or listed goods in relation to that sponsor: s 20. Provision is made in s 19 for approval for the importation or supply of therapeutic goods which are not included in the register. The applicant for the exemption is to be notified by the Secretary of the decision, and if it is adverse the notification must extend to the reasons for the decision: s 19(4). Application for registration or listing of therapeutic goods is provided for in ss 23-30.

As I have mentioned, there is a procedure for evaluation. Section 63(2) provides for the making of regulations for the establishment of committees to advise the minister or the Secretary on matters relating to therapeutic goods. This power has been implemented by Pt 6 of the Therapeutic Goods Regulations (the regulations). In particular, reg 36 establishes ADEC as an expert body to make medical and scientific evaluations of any drugs that the minister or the Secretrary refers to it for evaluation.

Section 25(3), (4) and (5) provide:

(3)

After therapeutic goods have been evaluated for registration, the Secretary must:

(a)

notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and

(b)

if the decision is to register the goods - give to the applicant a Register form to be filled in by the applicant in relation to the goods.

(4)

As soon as practicable after receiving the completed signed Register form, the Secretary must give to the applicant a certificate of registration of the goods.

(5)

The registration of therapeutic goods commences on the day specified for the purpose in the certificate of registration.

These are important provisions. Their effect is that the Secretary must act upon any decision to register and from the date of the commencement of the registration as specified in the certificate it will not be an offence under s 20 for a sponsor to import the relevant therapeutic goods into Australia for use in humans or to manufacture them for such supply in Australia; this will be because the goods are registered or listed goods in relation to that sponsor. It would be curious result if, upon the true construction of s 60, the decision to register, followed by the issue of a certificate with an effective date for commencement, were thereafter to be revoked upon reconsideration of that initially favourable decision, at the instance of some third party claiming its interests were affected by that initial decision. That which the law would have permitted from the commencement date specified in the certificate, by taking it outside the operation of s 20, the law subsequently would have placed within the operation of s 20.

Section 60(3) speaks of the revocation of the initial decision and the making of a decision "in substitution for the initial decision". Where the initial decision has been to register, to substitute a decision to refuse registration, retrospectively may render criminal conduct not such when committed. This suggests that s 60 does not operate in this way to take away on reconsideration that which was granted by the initial decision.

Further, the contrary interpretation, that contended for by SK Australia and SK Laboratories, is not readily accommodated to s 29. This states:

29.

Where goods are included in the Register in relation to a person, the goods remain so included until their registration or listing is cancelled under this Part.

Cancellation or registration or listing is dealt with by specific procedures laid down in s 30. In the present case, it will be recalled that the Alphapharm brand of cimetidine was placed on the register on 18 February 1993 , well before the purported request for reconsideration under s 60(2) on 8 June 1993 . There has been no attempted cancellation.

Conditions may be imposed upon the registration, and these may be varied or removed and new conditions may be imposed, at the request of the party with the registration or on the Secretary's own motion: s 28. These changes do not operate retrospectively. It should also be noted that s 29A makes it an offence for a person in relation to whom therapeutic goods are registered not to give to the Secretary in writing information of which that person becomes aware which contradicts information already furnished by that person under the Act, and information that indicates that the use of goods in accordance with the recommendations for their use may have an unintended harmful effect or may not be as effective as suggested in the application for registration or in information already furnished.

Section 30 is a provision central to the regulatory scheme established by Pt 3. As such, it applies to the registratiion of the Alphapharm brand of cimetidine. Like s 29A, s 30 manifests the concern of the Act, pursuant to s 4, with the quality, safety and efficacy of therapeutic goods.

Section 30 states:

(1)

The Secretary may, by notice in writing given to a person in relation to whom therapeutic goods are included in the Register, cancel the registration or listing of the goods if:

(a)

it appears to the Secretary that failure to cancel the registration or listing would create an imminent risk of death, serious illness or serious injury; or

(b)

the goods become exempt goods; or

(c)

the person requests in writing the cancellation of the registration or listing; or

(d)

the goods contain substances that are prohibited imports for the purposes of the Customs Act 1901.

(2)

Subject to subsection (3), the Secretary may, by notice in writing given to a person in relation to whom therapeutic goods are included in the Register, cancel the registration or listing of the goods if:

(a)

it appears to the Secretary that the quality, safety or efficacy of the goods is unacceptable; or

(b)

the goods have changed so that they have become separate and distinct from the goods as so included; or

(c)

the sponsor has refused or failed to comply with a condition to which the inclusion of the goods is subject; or

(ca)

the person has contravened subsection 29A(1) in relation to the goods; or

(d)

the goods become required to be included in the other part of the Register; or

(e)

the goods do not conform to a standard applicable to the goods or to a requirement relating to advertising applicable to the goods under the regulations; or

(f)

the annual registration or listing charge is not paid within 28 days after it becomes payable.

(3)

Where the Secretary proposes to cancel the registration or listing of goods in relation to a person under subsection (2) otherwise than as a result of a failure to pay the annual registration or listing charge, the Secretary must:

(a)

inform the person in writing that the Secretary proposes to cancel that registration or listing and set out the reasons for that proposed action; and

(b)

give the person a reasonable opportunity to make submsissions to the Secretary in relation to the proposed action.

(4)

Where a person makes submissions in accordance with paragrap (3)(b), the Secretary is not to make a decision relating to the cancellation until the Secretary has taken the submissions into account.

(5)

Where the Secretary cancels the registration or listing of goods in relation to a person, the goods cease to be registered or listed:

(a)

if the cancellation is effected under subsection (1) - on the day on which the notice of cancellation is given to the person; or

(b)

in any other case - on such later day as is specified in the notice.

(6)

Where the Secretary cancels the registration or listing of goods in relation to a person, the Secrertary:

(a)

may, in writing, require the person:

(i)

to inform the public, or a specified class of persons, in the specified manner and within such reasonable period as is specified, of the cancellation; or

(ii)

to take steps to recover any of the goods that have been distributed; and

(b)

must cause to be published in the Gazette, as soon as practicable after the cancellation, a notice setting out particulars of the cancellation.

(7)

A person who knowingly or recklessly refuses or fails to comply with a requirement under paragraph (6)(a) is guilty of an offence.

Penalty for a contravention of this subsection: $6,000.

In addition, s 31 confers wide powers upon the Secretary to require the provision of information or documents relating to such matters as formulation, composition, design specification and quality of therapeutic goods; the information may be sought of an applicant for registration or of a person in relation to whom the goods are registered.

Section 33 obliges the Secretary to publish a list of therapeutic goods included in the register not less than once in every 12 months. The register contains in relation to the relevant therapeutic goods information relating to the safe and effective use thereof, including information as to the usefulness and limitations of the goods: see the definition in s 32(6).

Section 32(1) provides:

(1)

The Register is not open for public inspection, but a person in relation to whom therapeutic goods are registered or listed may make a written request to the Secretary for a copy of the entry in the Register in relation to the goods and, where such a request is made, the Secretary must send a copy of that entry to the person (other than any part of that entry that was supplied in confidence by another person).

It will be apparent that s 32 does not provide for the provision of information from the register to a third party.

However, s 61 deals with "therapeutic goods information" a term which is defined therein as meaning information in relation to therapeutic goods which came into the possession of the department in connection with the performance of its functions. In certain circumstances such information may be released to the Director-General of the World Health Organisation, regulatory authorities of the Commonwealth, a State or a Territory, or to a national regulatory authority of another country. Section 61(7) provides that the Secretary may release therapeutic goods information the release of which is necessary to ensure the safe use of particular therapeutic goods or which relates to the reasons for the withdrawal of therapeutic goods from supply in this country. Section 61(8) authorises the use by the department of therapeutic goods information provided to it in relation to a matter, in the consideration of another matter within the functions of the department relating to therapeutic goods. The earlier legislation, as it stood at the time of the previous litigation in this court, did not contain such a provision.

Furthermore, s 61(6) provides that on application the Secretary may release to a person therapeutic goods information "of a kind identified in the regulations relating to therapeutic goods included in the Register". It was in reliance upon this provision that the department treated the letter by the SK Group solicitors of 15 October 1991 as a standing request for information as to the appearance of the Alphapharm brand of cimetidine on the register. That this was the approach taken appears from the department's response dated 23 October 1991 , the text of which I have set out earlier in these reasons.

The regulations provide that for the purposes of s 61(6) the Secretary may release by publication in the Gazette therapeutic goods information of a kind that relates to the evaluation of therapeutic goods by ADEC: reg 46(3). In addition, reg 46(2) authorises the release on application of therapeutic goods information in respect of an entry in the register, being information of the following kinds:

(a)

whether the goods are included in the Register, and, if the goods are included, the registration or listing number of the goods, the date on which the goods were listed or registered and the class in which the goods are included;

(b)

the name of the goods and the name and address of the sponsor of the goods;

(c)

if any ingredient in, or component of, the goods is derived from an animal, the type of the animal;

(d)

if the goods are supplied in a sterile state, the type of sterilisation used;

(e)

if the goods are drugs, therapeutic devices that contain drugs or therapeutic devices that are presented in a pharmaceutical form:

(i)

the quantity of goods to be in the primary pack; and

(ii)

the entry relating to the goods in the Poisons Standard; and

(iii)

the indications for the goods; and

(iv)

the dosage form of the goods and their physical appearance; and

(v)

the names and quantities of therapeutically active substances in the goods; and

(vi)

the presence or absence of any specific excipient in the goods; and

(vii)

the routes of administration of the goods; and

(viii)

the type of container in which the goods are to be packed; and

(f)

if the goods are therapeutic devices, a description of the devices, including the name and code (if any) by which the devices are classified.

The presence of these provisions in s 61 and in reg 46 provide no support for the notion that the legislation contemplates that during the process of evaluation a third party may obtain from the department information so as to equip itself, in the event of the application being successful, for a request to the minister for reconsideration under s 60.

It may be that the procedures offered by these provisions may be availed of by a third party, such as a competitor of a registered sponsor so as to assist the making of representations to the Secretary, after registration, to exercise the Secretary's powers of cancellation under s 30. Such a proposed course of conduct by the Secretary would bring with it the requirements of procedural fairness to the sponsor set out in s 30(3). But that it not this case

Conclusions

As I have indicated, it is not correct as a general proposition that for the purposes of s 60 the class of persons whose interests are affected by an initial decision is limited to applicants who have been wholly or partly unsuccessful in obtaining what they sought from the decision- maker. However, here the immediate issue is one of standing under s 60 to seek reconsideration of an initial decision under s 25 to register therapeutic goods. In answering that question, the registration system provided for in Pt 3 is of central importance.

There is no requirement for the provision of an opportunity to any third parties to be heard upon an application for registratiion. Reasons are required only where the decision is not to register: s 25(3). Nor is there a requirement that a decision under s 25(3) to register goods be published generally. I have referred to other provisions which provide for notification of decisions in the Gazette: see also s 60(2)(a) which gives to a person whose interests are affected by a decision, particulars of which are so notified in the Gazette, 90 days thereafter to request reconsideration. The provisions in s 61 for the release of therapeutic goods information are, so far as is relevant to the present case, limited to the provision of information in relation to therapeutic goods which are already on the register.

Further, an interpretation of the legislation which treated a third party as a person interested in, in the sense of opposed to, a grant of registration would not sit well with that object of the legislatiion which is concerned with the timely availability of therapeutic goods, after evaluatiion by an expert body and pursuant to a "complex and delicate administrative scheme": cf Block v Community Nutrition Institute (1984) 467 US 340 at 348 . If such a third party could intervene, the application might be made within 90 days after the decision first came to the notice of the complainant: see s 60(2)(b). At that time, as is the position in the present case, entry on the register may have been effected pursuant to the favourable decision under s 25 and trading commenced by the sponsor. As I have also indicated, the interposition at that stage of a review procedure with the substitution of a decision to refuse registration could have the effect of rendering unlawful activities by the sponsor which, at the time in which they were engaged, did not contravene the prohibition in s 20 upon importation and manufacture of unregistered therapeutic goods. Finally, the legislation contains elaborate provisions for cancellation of a registration. Those provisions do not operate other than prospectively.

My conclusions may be expressed as follows:

(i)

Where the initial decision under s 25 is not to register or to register with conditions, the applicant is a person whose interests are affected thereby, within the meaning of s 60.

(ii)

Where there has been an initial decision to register which has been acted upon by the effecting of registration, the operation of the Act upon the steps leading up to that registration is spent.

(iii)

The scope and purpose of the legislation in the above situation does not allow of third parties as persons who have an interest affected by the initial decision to grant registration and who may seek reconsideration and reversal of it under s 60.

(iv)

Any conditions on registration may be varied or removed and new conditions added by the Secretary at the request of the registered party or on the motion of the Secretary: s 28.

(v)

The Secretary may cancel registrations, but with prospective rather than retrospective effect: s 30(5).

(vi)

It may be that a third party in situations described in (iv) or (v) has "interests" which, within the meaning of s 60, are "affected" by the initial decision there described.

(vii)

Revocation by the minister under s 60(3) of an initial decision of the Secretary to cancel under s 30 may attract an application for review by the AAT under s 60(8) at the instance of a third party being one whose interests are affected by the revocation of the initial decision to cancel.

(viii)

It is unnecessary to decide questions of standing under s 60 as to the situations outlined above in paras (iv)-(vii).

The result, in my opinion, is that the minister and Alphapharm should succeed upon their respective appeals and the order of review granted by the primary judge should be set aside. This conclusion makes it unnecessary to decide whether Alphapharm should have leave to appeal in No G910 upon the amendment issue. Had it been necessary to decide the matter, I would have not favoured the grant of leave. I would have accepted the submissions of counsel for SK Laboratories and SK Australia that no issue of general importance arose. I agree with what is said upon the point and upon the issue as to misnomer, by Davies J.

I agree with the orders proposed by Davies J.