Becton Dickinson Pty Ltd and Minister for Health and Aged Care
[2025] ARTA 16
•10 January 2025
Becton Dickinson Pty Ltd and Minister for Health and Aged Care [2025] ARTA 16 (10 January 2025)
Applicant/s: Becton Dickinson Pty Ltd
Respondent: Minister for Health and Aged Care
Tribunal Number/s: 2024/5014, 2024/5038 & 2024/5044
Tribunal:Deputy President Britten-Jones
Place:Melbourne
Date:10 January 2025
Decision:The Tribunal dismisses the applications for review under s 101(1)(b) of the Administrative Review Tribunal Act 2024 (Cth).
...............[SGD].........................................................
Deputy President Britten-Jones
Catchwords
APPLICATION FOR DISMISSAL – question of standing – is there a reviewable decision -
statutory interpretation of the phrase “a person whose interests are affected by a decision” in s 60(2) of the Therapeutic Goods Act 1989 (Cth) - Tribunal dismisses the applications under s 101(1)(b) of the Administrative Review Tribunal Act 2024 (Cth)Legislation
Administrative Appeals Tribunal Act 1975 (Cth)
Administrative Decisions (Judicial Review) Act 1977 (Cth)
Administrative Review Tribunal Act 2024 (Cth)Administrative Review Tribunal (Consequential and Transitional Provisions No. 1) Act 2024 (Cth)
Development Allowance Authority Act 1992 (Cth)
Judiciary Act 1903 (Cth)
Therapeutic Goods Act 1989 (Cth)Cases
Allan v Transurban City Link Limited [2001] HCA 58; (2001) 208 CLR 167
Alphapharm Pty Ltd v Smithkline Beecham (Australia) Pty Ltd (1994) 49 FCR 250
Argos Pty Ltd v Corbell [2014] HCA 50; (2014) 254 CLR 394
Australian Vaccination-Risks Network Inc v Secretary, Department of Health [2022] FCAFC 135; (2022) 292 FCR 1
Bateman’s Bay Local Aboriginal Land Council v The Aboriginal Community Benefit Fund Pty Ltd (1998) 194 CLR 247
Director-General of Social Services v Hales (1983) 47 ALR 281
Project Blue Sky Inc v Australian Broadcasting Authority [1998] HCA 28; (1998) 194 CLR 355
Right to Life Association (NSW) Inc v Secretary, Department of Human Services & Health (1995) 56 FCR 50
Smithkline Beecham (Australia) Pty Ltd v Chipman [2002] FCA 674Secondary Materials
Michelle Sanson, Statutory Interpretation (Oxford University Press, 2nd ed, 2017)Dennis Pearce, Statutory Interpretation in Australia (LexisNexis Australia, 10th ed, 2024)
Statement of Reasons
This is an application by the respondent brought under s 42A(4) and ss 42B(1)(a) or (b) of the Administrative Appeals Tribunal Act 1975 (Cth) (AAT Act) for dismissal of three applications for review made by the applicant.
Since the filing at the Administrative Appeals Tribunal (AAT) of the originating process and this application, the Administrative Review Tribunal (Tribunal) has been established by the Administrative Review Tribunal Act 2024 (Cth) (ART Act) which commenced on 14 October 2024. Transitional provisions under the Administrative Review Tribunal (Consequential and Transitional Provisions No. 1) Act 2024 (Cth) provide that unfinalised proceedings in the AAT must be continued and finalised by the Tribunal in a manner that is efficient and fair.
The respondent pursues the dismissal application under ss 97 and 101(1) (a) or (b) of the ART Act which are in similar terms to ss 42A(4) and 42B(1) of the AAT Act. The respondent considers that the preferred path is to dismiss the three applications for review under s 97 on the basis that there is no reviewable decision. The applicant contends to the contrary that decisions reviewable by the Tribunal have been made under the Therapeutic Goods Act 1989 (Cth) (TG Act)[1] and that it has standing to apply to review those decisions as a person whose interests are affected by them.
[1] All references herein to legislation are to the Therapeutic Goods Act 1989 (Cth) unless otherwise stated.
The applicant has filed a statement of Hugh Cameron dated 10 October 2024 and has lodged various written submissions. The respondent has filed a statement from Joshua Smith dated 1 November 2024 and lodged written submissions. Mr Smith is a Principal Lawyer in the Regulatory Legal Services Division of the Department of Health and Aged Care (the Department) and works with the Therapeutic Goods Administration (TGA). I heard oral submissions from the parties on 27 November 2024. Further written submissions from the applicant were provided on 3 December 2024 and from the respondent on 16 December 2024.
Background
The applicant, according to its website, is an Australian subsidiary of one of the largest global medical companies in the world. It commenced operations in Australia in 1981. It manufactures and supplies in Australia two pre-filled saline flush syringe products which are Class III medical devices included on the Australian Register of Therapeutic Goods (the Register) from 24 November 2010 and 7 July 2014. A similar product, which is functionally equivalent and clinically interchangeable, is supplied in Australia by other companies including ITL Australia (ITL) and YES Medical (YES) whose syringes have been included more recently on the Register as Class IIa.
The applicant contends that these other syringes should also have a classification of Class III. The applicant has brought the three applications for review in the Tribunal seeking to set aside the decisions by which these other syringes were included on the Register as Class III medical devices. The applicant’s expert, Dr Claire Rickard, Professor of Infection Prevention and Vascular Access, University of Queensland, supports the applicant’s contention and expresses an opinion that these medical devices should be classified as Class III. She expresses her concern with respect to any potential downgrade of these medical devices to Class IIa ‘as these devices can potentially causing (sic) harm or even death from infection’.
Mr Cameron, who is the Regulatory Affairs Director of the applicant, explained that there is a significant difference in manufacturing costs depending on the classification given to the product. He said in his statement:
(a)The general trend is that prefilled saline flush syringes that have a classification lower than Class III are sold at a price lower than Class III prefilled saline flush syringes.
(b)There are two main drivers behind the difference at which these functionally equivalent and clinically interchangeable prefilled saline flush syringe products are sold and they both relate to the classification of the medical devices.
(c)The first driver is the cost to bring them to, or maintain them on, market. These can be described as regulatory costs. These include the cost to initially demonstrate the appropriate level of quality, safety and efficacy required for Class III medical devices for regulators. These costs also include the preapproval that is required for many significant changes that are made to Class III medical devices.
(d)The second driver relates to manufacturing costs. The regulations relating to Class III medical devices require the establishment of a manufacturing site and relevant quality control and manufacturing procedures which have a cost that is higher than for products classified as Class IIa.
(e)These regulatory and manufacturing costs have a direct impact on the price at which the applicant can sell its syringes in Australia. The different classifications establish an unfair market if functionally equivalent and clinically interchangeable medical devices such as the other syringes are included on the Register as Class IIa medical devices. This also means that the other syringes are brought to market with a lower safety profile than the applicant’s medical devices.
(f)The applicant is concerned that any negative post market actions, such as adverse events caused by the other syringes, will incorrectly involve the applicant’s medical devices in any investigation and potential recalls because the products are functionally equivalent and clinically interchangeable.
The Secretary of the Department made three decisions (the Initial Decisions) to include the other syringes as medical devices in Class IIa of the Register on 1 March 2024 (ITL), 15 March 2024 (YES) and 22 April 2024 (ITL). The applicant became aware of these inclusions on the Register from the public summary which records entries on the Register.
On 6 May 2024, the applicant sought merits review of the Initial Decisions under s 60(2) of the TG Act as a person whose interests are affected by an initial decision. It asserted that there were two overarching principles that form the basis for the appeal against the inclusion of the medical devices in the Register under the lower risk classification of Class IIa:
(a)The first is the need for the TGA to treat analogous products in a consistent manner and apply the same regulatory scrutiny to these products.
(b)The second, in terms of public health and safety, is to ensure that therapeutic products have the appropriate level of regulatory scrutiny applied to them before they are included in the Register for use in the Australian clinical setting.
By letters dated 6 June 2024, the TGA advised the applicant that it had determined that the requests for reconsideration were not valid requests under s 60(2) of the TG Act because the applicant was not a person whose interests are affected by the Initial Decisions.
On 18 July 2024, the applicant lodged the three applications for review in the AAT.
Issues for the Tribunal to Determine
The applicant says that it has standing to apply for review because its interests are affected by the Initial Decisions. The respondent denies the applicant’s interests are sufficiently affected and says that there is no reviewable decision. These two propositions by the respondent are related because the respondent says there is no reviewable decision because the applicant’s interests were not affected by the initial decisions. The principal question for the Tribunal is whether the applicant has standing which depends upon whether the applicant is a person affected by the Initial Decisions for the purposes of s 60(2).
Decisions under the Therapeutic Goods Act and application to the Administrative Review Tribunal
Section 60 of the TG Act provides two tiers of merits review from a decision of the Secretary of the Department; first, by the relevant Minister by way of reconsideration; and second, by the Tribunal in relation to the reviewable decision by the Minister.
Section 60(1) provides the following definitions:
(a)decision has the same meaning as in the ART Act;
(b)initial decision means a decision of the Secretary or of a delegate of the Secretary under provisions including Part 4-5 (including medical devices in the Register);
(c)reviewable decision means a decision of the Minister under subsection (3).
Pursuant to s 60(2), a person whose interests are affected by an initial decision may … request the Minister to reconsider the decision. As soon as practicable after receiving such a request, the Minister, pursuant to s 60(3), must reconsider the initial decision and either confirm or revoke it, or revoke and make a decision in substitution of the initial decision. If no reconsideration decision is received within 60 days, the Minister is taken to have confirmed the initial decision by operation of s 60(4). Section 60(8) provides the gateway to the Tribunal by allowing an application to be made to the Tribunal for review of the Minister’s decision.
Section 12 of the ART Act provides that a decision is a reviewable decision if an Act, in this case the TG Act, provides for an application to be made to the Tribunal for review of the decision. It is the decision of the Minister, and not the decision of the Secretary, which is the reviewable decision.
Section 17(1) of the ART Act adopts the same qualifying phrase used in s 60(2) of the TG Act namely that a person whose interests are affected by a reviewable decision may apply to the Tribunal for review of the decision. However, it is important to note that s 17(1) of the ART Act does not represent the starting point for determination of the question of standing. The starting point is s 60(2). If the applicant establishes pursuant to s 60(2) that it is a person whose interests are affected by an initial decision, then the Minister can reconsider that decision and make a reviewable decision. The applicant’s entitlement to request the Minister to reconsider the decision would ultimately provide it with standing to apply to the Tribunal if it were not satisfied with the Minister’s decision.
The applicant says that it made a valid request to the Minister by the letters dated 6 May 2024 for reconsideration under s 60(2), and that the Minister failed to reconsider the Initial Decisions and therefore the Minister is deemed by operation of s 60(4) to have confirmed the Initial Decisions. The applicant contends that the deemed decisions became the decisions that are reviewable by the Tribunal under s 60(8).
Is there a Reviewable Decision?
I will now consider whether there is a decision that is reviewable by the Tribunal. There are two potential paths towards a finding of a reviewable decision.
First, the applicant points to the definition of decision in s 60(1) which says that decision has the same meaning as in the ART Act. Decision is defined broadly in s 4 of the ART Act so as to include the doing or refusing to do any act or thing. The applicant says that the refusal to reconsider the Initial Decisions as notified by the letter to it dated 6 June 2024 constitutes a decision which comes within the broad definition in s 4 of the ART Act and would therefore be a decision within s 60(1) of the TG Act. I accept the applicant’s contention up to this point but it is not enough for the applicant to show that there is a decision under s 60(1). This is because there is a separate definition of reviewable decision. It follows that not all decisions caught by s 60(1) are reviewable by the Tribunal. It is only a reviewable decision as defined in s 60(1) that can be reviewed by the Tribunal. A reviewable decision has a meaning which is limited to a decision of the Minister under s 60(3). The refusal decision by letter dated 6 June 2024 does not come within the limited definition and is therefore not a reviewable decision, subject to what I say below.
Second, the applicant says that by operation of s 60(4) the Minister is taken to have confirmed under s 60(3) the Initial Decisions and therefore there is a reviewable decision. The applicant says that it made a request under s 60(2) and that it did not receive notice of the decision of the Minister on reconsideration. Dealing first with the request, there is a strong argument that if the request was not made by a person whose interests are affected by an initial decision then there would be no request for the purpose of s 60(2). It is only a person whose interests are affected who may make the request. If the request is made by someone else without the requisite interest then it is arguable that a request pursuant to s 60(2) has not been made. In that situation there would be no valid request and therefore no obligation on the Minister to reconsider the initial decision under s 60(3). The deeming provision in s 60(4) would not operate in this situation because there was never an obligation on the Minister to reconsider under s 60(3).
Whilst there is some logic to the approach in the above paragraph, Lockhart J in Director-General of Social Services v Hales,[2] warned against taking too narrow or pedantic an approach to whether a decision falls within the scope of review by the Tribunal. Further, there is some support for finding that there is a reviewable decision from the High Court in Allan v Transurban[3] where the relevant Authority notified Mr Allan in response to his request for a reconsideration that it would not reconsider its decision because he was not a person affected in the necessary statutory sense. The High Court noted that by force of s 119(4) of the Development Allowance Authority Act 1992 (Cth) (a deeming provision similar to s 60(4) of the TG Act), the notice to reconsider was ‘treated’ as confirmation of the decisions. Although there was no discussion of the issue by the High Court, this would suggest that they were content to accept that there was a deemed decision which was a reviewable decision.
[2] (1983) 47 ALR 281, 305-6.
[3] [2001] HCA 58 at [8].
The difference between the two approaches may not amount to a practical difference because either way the applicant will need to establish standing by showing that it is a person whose interests are affected by the Initial Decisions. My view is that there is a reviewable decision as defined in s 60(1) because the applicant did make a request to the Minister to reconsider the Initial Decisions (s 60(2) of the TG Act) and then did not receive notice of a decision from the Minister (s 60(4) of the TG Act) such that the Minister is taken to have confirmed under s 60(3) the Initial Decisions.
Statutory interpretation of the phrase “a person whose interests are affected by a decision”
It is useful at this stage to introduce Alphapharm Pty Ltd v Smithkline Beecham (Australia) Pty Ltd[4] (the Alphapharm case) to which I will return in detail later in these reasons. Gummow J in the Alphapharm case considered how s 60 operates to give an applicant a right of review under the AAT Act (now the ART Act):[5]
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 stage 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.
[4] (1994) 49 FCR 250 (‘Alphapharm’).
[5] Ibid 270-1.
In both the Alphapharm case and the present case, the Minister did not reconsider the initial decision because ‘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).’[6] The procedure that followed in the Alphapharm case was an application for an order of review under the Administrative Decisions (Judicial Review) Act 1977 (Cth) (the ADJR Act) whereas in the present case it was an application for merits review to the Tribunal. However, the same issue arose namely whether ‘the applicant lacked sufficient standing to request reconsideration by the Minister of the initial decision to approve the registration.’[7]
[6] Ibid.
[7] Ibid 271.
The TG Act is legislation which has a built-in merits review process by way of reconsideration. As Gummow J said in the Alphapharm case, there are two stages in the operation of s 60 of the TG Act. The first stage is to determine whether the applicant is a person under s 60(2) who may request the Minister to reconsider the Initial Decisions. If so, the applicant would be entitled to seek merits review of those decisions by the Tribunal. It is this first stage of the operation of s 60 which is relevant for the purposes of determining if the applicant has standing. If the applicant cannot establish that it is a person affected by the Initial Decisions then it will not have standing and the applicant will fail at the first stage.
Each of the three justices who wrote reasons in the Alphapharm case said that the question of standing was to be determined by giving meaning to the phrase “interests are affected” in s 60(2) by reference to the scope, purpose and objects of the TG Act.
The issue for the Tribunal to determine is whether, pursuant to s 60(2), the applicant is a person whose interests are affected by the Initial Decisions. This issue requires the Tribunal to determine how one should interpret and apply s 60(2) of the TG Act.
The approach of the Full Court in the Alphapharm case is consistent with the approach of the High Court in Project Blue Sky Inc v Australian Broadcasting Authority: [8]
The primary object of statutory construction is to construe the relevant provision so that it is consistent with the language and purpose of all the provisions of the statute. The meaning of the provision must be determined "by reference to the language of the instrument viewed as a whole". In Commissioner for Railways (NSW) v Agalianos, Dixon CJ pointed out that "the context, the general purpose and policy of a provision and its consistency and fairness are surer guides to its meaning than the logic with which it is constructed". Thus, the process of construction must always begin by examining the context of the provision that is being construed.
(footnotes removed)
[8] [1998] HCA 28; 194 CLR 355 at [69].
Instead of interpreting s 60(2) by reference to its context and purpose in the TG Act, the applicant sought to give it meaning based on how the phrase “interests are affected” in other statutes had been interpreted. The applicant relied on judicial authorities that gave meaning to the same phrase as it is found in the predecessor to s 17(1) of the ART Act and s 3(4) of the ADJR Act. The applicant contended that the phrase should be given a consistent meaning in each of the statutes it was found. I reject the applicant’s contention for the reasons that follow.
In the Alphapharm case, Davies J considered the phrase “interests are affected” when used in a statute which provides for the administrative review of administrative decisions:[9]
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.
[9] Alphapharm (n 4) at 260B.
Gummow J took a similar approach. He noted that the phrase “a person whose interests are affected by the decision” and similar phrases appear in a variety of statutes as the identification of the persons who are given standing to seek administrative and judicial review but he specifically warned against drawing any common meaning with respect to the phrase:[10]
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.
[10] Ibid at 272C.
The later decision of Allan v Transurban City Link Ltd[11] considered the phrase “a person who is affected by a reviewable decision” in s 119(1) of the Development Allowance Authority Act 1992 (Cth). This is an example of a statute which, like the TG Act, provides for administrative or merits review of administrative decisions. The majority said:[12]
The expression “affected by” and cognate terms appear in a range of laws of the Commonwealth. … It is necessary to answer the questions posed above in respect of s 119(1) of the Authority Act by reference to the subject, scope and purpose of that statute, rather than by the application of concepts derived from decisions under the general law respecting what has come to be known as “standing”.
[11] [2001] HCA 58 at [15].
[12] Ibid.
In the present case, the Minister considered that the applicant lacked standing which was why he refused to entertain the request for reconsideration. The applicant disagrees with the Minister. The Tribunal must now consider the same issue.
The Legislative Scheme for Registration of a Medical Device under the TG Act
I turn now to consider the legislative scheme in the TG Act for the purpose of construing the phrase “a person whose interests are affected by an initial decision”.
The objects of the TG Act include to do the following:
4(1)(a) provide 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:
(i) used in Australia, whether produced in Australia or elsewhere; or
(ii) exported from Australia;
Chapter 2 of the TG Act provides for the Australian Register of Therapeutic Goods (the Register) which is maintained by the Secretary of the Department for the purpose of compiling information in relation to, and providing evaluation of, therapeutic goods including medical devices which are dealt with in Chapter 4.
The purpose of Chapter 4, as set out in s 41B, is to ensure the safety and satisfactory performance of medical devices by:
(a) setting out particular requirements for medical devices; and
(b) establishing administrative processes principally aimed at ensuring those requirements are met; and
(c) providing for enforcement through a series of offences and civil penalty provisions.
Part 4-5 sets out the kinds of medical devices that can be included in the Register. It includes how an application can be made to include a kind of medical device in the Register. The process is as follows:
(a)A person may make an application to the Secretary under s 41FC for a kind of medical device to be included in the Register.
(b)The applicant must certify under s 41FD that the device is a medical device and is correctly classified according to medical device classifications.
(c)If an application is made under section 41FC for a kind of medical device to be included in the Register in relation to a person, the Secretary, under s 41FDB(1), must carry out an assessment of whether the requirements set out in subsection (2) have been met in relation to the application. The requirements in s 41FDB(2) are:
(a) the application must be made:
(i) in accordance with the form approved, in writing, by the Secretary for that classification of medical device; or
(ii) in such other manner as is approved, in writing, by the Secretary for that classification of medical device;
(b) the prescribed application fee for that classification of medical device must be paid;
(c) the application must be delivered to an office of the Department specified by the Secretary;
(d) the application must be accompanied by information that is:
(i) of a kind determined under subsection (7) for that classification of medical device; and
(ii) in a form determined under subsection (8) for that classification of medical device;
(e) if regulations made for the purposes of section 41EA require the manufacturer of the kind of device to have a conformity assessment certificate relating to the kind of medical device before an application under section 41FC can be made--such a certificate is in force;
(f) the applicant has certified the matters in section 41FD.
(d)Section 41FDB(3) says that an application passes preliminary assessment if the Secretary:
(a) has carried out an assessment, under subsection (1), in relation to the application; and
(b) is satisfied that the requirements set out in subsection (2) have been met in relation to the application.
(e)If the application has not passed preliminary assessment, the Secretary, under s 41FDB(3), must refuse the application and give notice of the refusal to the applicant under s 41FG.
(f)Section 41FF(1) says that if:
(a) an application for a kind of medical device to be included in the Register in relation to a person has passed preliminary assessment; and
(b) the application has not been selected for audit under section 41FH;
the Secretary must include the kind of device in the Register in relation to the person.
(g)If the application is refused then notice of the refusal must be given to the applicant under s 41FG.
(h)For those applications that have passed preliminary assessment, s 41FH provides for a process of auditing:
(a) the Secretary must select for auditing any application for a kind of medical device to be included in the Register that is an application of the kind prescribed by the regulations; and
(b) the Secretary may select for auditing any other application for a kind of medical device to be included in the Register.
(i)If an application is selected for auditing:
(a) the Secretary must give the applicant a written notice (the selection notice) that:
(i) informs the applicant of the selection; and
(ii) requires the applicant to provide, within the period specified in the notice, information or documents that the Secretary is satisfied is relevant to the audit.
(j)In auditing the application, the Secretary, under s 41FI(1A), may, by written notice given to the applicant, require the applicant to deliver to the office to which the application was made a reasonable number of samples of the kind of medical device to which the application relates.
(k)The Secretary must decide to include, or not to include, the kind of device to which the application relates in the Register, in relation to the person to whom the application relates, depending on if the Secretary is satisfied as to all such aspects considered in the audit.
(l)After auditing the application, the Secretary, under s 41FJ, must:
(a) notify the applicant in writing of his or her decision within 20 working days after the decision is made; and
(b) if the decision is not to include the kind of device to which the application relates in the Register—state in the notice the reasons for the decision; and
(c) if the decision is to include the kind of device in the Register and all assessment fees for the application that are due and payable have been paid:
(i) include the kind of device in the Register, in relation to the person in relation to whom the application was made; and
(ii) give the applicant a certificate of the inclusion of the kind of device in the Register.
Case Law
In 1994 the Full Court of the Federal Court in the Alphapharm case considered the question as to whether one pharmaceutical company had standing to seek to set aside a decision made under the TG Act in relation to the product of another pharmaceutical company which had been included on the Register. The respondent relies heavily on the Alphapharm case to deny the applicant standing on similar facts.
The Alphapharm case is instructive because it considered the legislative scheme in the TG Act and considered the question of whether Smithkline Beecham (who was in an analogous position to the applicant) was a person whose interests were affected by an initial decision under s 60(2). As Gummow J said, the primary issue on the appeal was whether the primary judge erred in her conclusions as to standing for the purposes of s 60(2). In that regard, Gummow J said:[13]
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.
…
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. … 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.
[13] Alphapharm (n 4) 272.
Gummow J concluded:[14]
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 registration. Reasons are required only where the decision is not to register (s 25(3)). …
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 legislation which is concerned with the timely availability of therapeutic goods, after evaluation by an expert body and pursuant to a “complex and delicate administrative scheme”: cf Block v Community Nutrition Institute 467 US 340 at 348 (1984). 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.
[14] Ibid at 279 – 80.
Davies J came to the same conclusion as Gummow J but gave separate reasons. Davies J said:[15]
[15] Ibid at 260 – 1.
… 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.
…
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.
…
The Act recognises that persons other than the sponsor may have interests which may be taken into account in the making of the decision. … In Re Welborn and Department of Health, Housing and Community Services (1993) 18 AAR 193, 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.
Davies J concluded:[16]
… SmithKline has not demonstrated that it had a relevant interest entitling it to request reconsideration of the initial decision. The interest which SmithKline 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 cimitidine and reduce its price — is not an interest which the Act recognises for the purposes of s 60(2).
[16] Ibid at 263F.
The Alphapharm case has since received positive judicial consideration and has been distinguished in a way that clarifies its application.
Right to Life Association (NSW) Inc v Secretary, Department of Human Services & Health[17] was another decision of the Full Court of the Federal Court dealing with the TG Act. Gummow J referred to the Alphapharm case and said:
In Alphapharm Pty Ltd v SmithKline Beecham (Australia) Pty Ltd (1994) 49 FCR 250 at 280, one reason for not treating the applicant as a person whose interests were affected, within the meaning of s 60(2) of the Act by a decision to register, was that the object of the legislation was the timely availability of therapeutic goods after evaluation by an expert body pursuant to a complex and delicate administrative scheme; to treat a third party as “interested” in the decision to grant registration because that party was opposed to the grant, would disrupt that administrative scheme established by the statute. Put slightly differently, the purposes or ends which the Parliament sought to advance by enacting the statute were not those with which the applicant was concerned and seeking to advance by the processes of judicial review: see the discussion by Sackville J in North Coast Environment Council Inc v Minister for Resources (1994) 55 FCR 492.
[17] (1995) 56 FCR 50 at 84 – 5 (‘Right to Life’).
Bateman’s Bay Local Aboriginal Land Council v The Aboriginal Community Benefit Fund Pty Ltd[18] (the Bateman’s Bay decision) was a case where the respondent parties were found to have standing because they:
… had an interest in the observance by the appellants of the statutory limitations upon their activities with respect to contributory funeral funds which, as a matter of practical reality, was immediate, significant and peculiar to them. The primary judge found that because the parties would be operating in substantially the same limited market it was highly probable that, if not restrained from commencing and concluding their activities, the appellants would cause severe detriment to the business of the respondents. That, in the circumstances of this litigation, gave the respondents a sufficient special interest to seek equitable relief.
[18] (1998) 194 CLR 247 at 267- 8 [52].
Prior to reaching the conclusion above, the plurality in the Bateman’s Bay decision referred to the Alphapharm case and said:[19]
Upon the true construction of its subject, scope and purpose, a particular statute may establish a regulatory scheme which gives an exhaustive measure of judicial review at the instance of competitors or other third parties. An example is the special but limited provision by the legislation considered in Alphapharm Pty Limited v SmithKline Beecham (Australia) Pty Ltd for judicial review of successful applications for registration. However, the circumstance that the plaintiff conducts commercial activities in competition with those which it seeks to restrain is not necessarily insufficient to provide it with a sufficient interest in the subject matter of the action.
[19] Ibid 266 [48].
Allan v Transurban City Link Ltd[20] is a decision of the High Court, which commenced in the AAT, where it was decided that Mr Allan was not a person affected by the relevant decision to grant a certificate. The procedural background was similar to the applicant’s in this case whose request for a reconsideration by the Minister was refused:
[8] … Mr Allan requested the Authority to reconsider its decisions to issue the certificates. He did so in purported reliance upon s 119 of the Authority Act. He maintained that, within the meaning of s 119(1), these were “reviewable decision[s]” and that he was “[a] person who [was] affected by” those decisions. On 11 April 1996, the Authority notified Mr Allan that it would not reconsider its decisions because he was not a “person affected” in the necessary statutory sense. By force of s 119(4), that was treated as confirmation of the decisions.
[9] Section 25 of the Administrative Appeals Tribunal Act 1975 (Cth) (“the AAT Act” ) states that an enactment (a term defined in s 3(1) so as to include a statute of the Parliament of the Commonwealth) may provide for the making of applications to the Administrative Appeals Tribunal (“the AAT”) for review of decisions made in exercise of powers conferred by that enactment. In that event, s 27(1) of the AAT Act operates. This authorises the making of an application to the AAT by or on behalf of a person “whose interests are affected by the decision”. Section 120 of the Authority Act provides for the making of applications to the AAT for the review of decisions by the Authority under s 119. By this means, the operation of the AAT Act is engaged.
[20] (2001) 208 CLR 167; [2001] HCA 58 at [8] and [9] (‘Allan v Transurban’).
The High Court in Allan v Transurban[21] held that a person other than the one who applies for the grant of a tax certificate pursuant to the Development Allowance Authority Act will not be a “person affected by a reviewable decision” and will not have the requisite “standing” for the purposes of s 119(1) of that Act. The Court said:
[15] The expression “affected by” and cognate terms appear in a range of laws of the Commonwealth. This is not the occasion for a disquisition on that topic. It is necessary to answer the questions posed above in respect of s 119(1) of the Authority Act by reference to the subject, scope and purpose of that statute, rather than by the application of concepts derived from decisions under the general law respecting what has come to be known as “standing”. “Standing” is a metaphor to describe the interest required, apart from a cause of action as understood at common law, to obtain various common law, equitable and constitutional remedies.
[16] In Re McHattan and Collector of Customs (New South Wales)7, Brennan J stated that “[a]cross the pool of sundry interest, the ripples of affection may widely extend”. However, as Davies J pointed out in Alphapharm Pty Ltd v SmithKline Beecham (Australia) Pty Ltd, Brennan J “did not propose that any ripple of affection would be sufficient to support an interest”. A particular statute may establish a regime which specifically provides for its own measure of judicial review on the application of persons meeting criteria specified in that statute. The present case involves such a statute. The starting point, as indicated by several authorities in the Full Court of the Federal Court, is the construction of the Authority Act with regard to its subject, scope and purpose.
[17] Transurban correctly submitted that the phrase in s 119(1) of the Authority Act “who is affected by a reviewable decision” has an ambulatory operation. What serves to identify a person as one affected by a reviewable decision will vary having regard to the nature of the reviewable decision itself. There is a range of such decisions by the Authority.
[21] Ibid.
The applicant relies upon a decision of Weinberg J in SmithKline Beecham (Australia) Pty Ltd v Chipman[22] to support its case that a person in the position of the applicant has standing under s 60(2). This was an application for orders of review under the ADJR Act and for judicial review under s 39B of the Judiciary Act 1903 (Cth). In that case Weinberg J considered both the Alphapharm case and Allan v Transurban[23] and said:
[92] The assumed facts go well beyond those established in Alphapharm. They demonstrate that SmithKline has had a longstanding and ongoing involvement with the TGA. It has frequently made submissions to that body regarding the principles by which therapeutic goods should be listed in the ARTG. It has also demonstrated that there is a real chance that it may be significantly prejudiced if Ausrox remains registered.
[93] I do not regard Alphapharm as requiring SmithKline to be denied standing. The reasoning of Davies J indicates that s 60(2) is not confined to refusals to grant registration, but may also be invoked by aggrieved third parties in circumstances where registration has been granted. That reasoning seems to me to be cogent.
[22] [2002] FCA 674 (‘SmithKline Beecham’).
[23] Allan v Transurban (n 20).
The applicant in the present case adopts the reasons of Weinberg J who said with respect to s 60(2) of the TG Act:[24]
In my opinion, there is nothing in the text of the Act, or in its subject, scope or purpose, that suggests that a third party whose interests are affected by a decision to register a new product may not request the Minister to reconsider that decision. Section 60(2) commences with “[A] person”, words of the greatest generality, and not words such as “[A]n applicant for registration”.
The policy arguments advanced by the respondents against this interpretation do not lead to the conclusion that the language of the subsection should be given other than its ordinary and natural meaning.
Another argument in support of SmithKline's position is that the Act expressly allows for conditions to be attached to any registration of drugs. An applicant for such registration who is aggrieved by any such condition must surely, as a matter of principle, be able to invoke s 60(2) to request the Minister to reconsider that condition. That would be so even where the goods have been registered.
It must be borne in mind that the Act is concerned not simply with the timely availability of therapeutic goods, but also with the vital issue of public safety. It seems to me that the Act, upon its proper construction, contemplates that a third party, whose interests are affected by the registration of a competitor's goods, may bring to the notice of the Minister matters affecting public safety by requesting reconsideration of the decision to register those goods.
[24] SmithKline Beecham (n 22) [97] – [100].
Weinberg J noted that the judgement of Gummow J in the Alphapharm case was not ‘directly in point in determining the applicant’s standing to seek judicial review in the present case.’[25] Weinberg J accepts in his final analysis that ‘there is doubt as to whether the applicant has standing, under s 60(2) to seek merits review.’[26] However, his Honour’s ultimate view was that there was no basis for the Court, in the exercise of its discretion, to decline to entertain an application for judicial review.[27]
[25] Ibid at [95] (emphasis in original).
[26] Ibid [105].
[27] Ibid.
This distinction between the approach to be taken on merits review compared to judicial review was highlighted in Argos Pty Ltd v Corbell[28] which was a judicial review case that distinguished the Alphapharm case. Gageler J said:[29]
Alphapharm Pty Ltd v SmithKline Beecham (Australia) Pty Ltd, on which the first respondent principally relies, does not assist the first respondent's argument. The holding of the Full Court of the Federal Court in that case was that a pharmaceutical company was not a person whose interests were affected by a decision to register its competitor's drug under the Therapeutic Goods Act 1989 (Cth) (“the TG Act”) for the purposes of a provision of that Act which conferred an entitlement to administrative review of the merits of a decision made under the TG Act. There was no dispute in that case that the pharmaceutical company was a person aggrieved by the decision to deny it administrative review so as to entitle it to challenge that decision under the ADJR Act. The contextual distinction so illustrated by the case was articulated by Davies J when he explained that a review “which forms part of the process of administrative decision-making, is provided to promote the achievement of the objects of the statute” but that “the object of judicial review is to ensure that the law is observed”. Allan v Transurban City Link Ltd was similarly a case about administrative review.
[28] (2014) 254 CLR 394; [2014] HCA 50.
[29] Argos Pty Ltd v Corbell (2014) 254 CLR 394; [2014] HCA 50 at [82].
Australian Vaccination-Risks Network Inc v Secretary, Department of Health[30] is a case about standing in the context of the TG Act. Rares J (with whom Katzmann and Wigney JJ agreed) applied the Alphapharm decision and said:
[30] [2022] FCAFC 135; (2022) 292 FCR 1.
[33] In Alphapharm Pty Ltd v Smithkline Beecham (Australia) Pty Ltd (1994) 49 FCR 250 … each of Davies, Burchett and Gummow JJ emphasised that s 60 of the then form of the Therapeutic Goods Act provided a right to challenge a decision only to an applicant for registration whose interests were affected by it, and not to third parties. They held that a competitor of an applicant for registration of a therapeutic good had no standing because the subject matter, scope and purpose of the Therapeutic Goods Act, as it then stood, did not support such a construction of that Act. As Burchett J said (at 264F):
“The other view would turn legislation, one of the express objects of which (see section 4) is to provide for the ‘timely availability of therapeutic goods’ into legislation setting up institutional provision for delay.”
[34] That position is reinforced in the current version of the Act, as the Secretary's notice of contention propounds. The Act now contains s 60(2AB), which was inserted in 2018. It provides, relevantly, that, if the Secretary or a delegate makes a decision, first, under s 22D in relation to the registration of a therapeutic good under s 22C or, secondly, under s 25(3) in relation to the application for provisional registration of a medicine in accordance with ss 29D, 30(1) and (2)(a), a person is not entitled to request the Minister to reconsider the decision unless that person made the application. The Secretary decides such applications internally, without advertising, and must only give reasons if the application is refused. Thus, under the Therapeutic Goods Act, only the applicant for registration of the therapeutic good is given standing to apply for an internal review of such a decision not to register it.
[35] In Bateman's Bay Local Aboriginal Land Council v The Aboriginal Community Benefit Fund Pty Ltd (1998) 194 CLR 247 at [48], Gaudron, Gummow and Kirby JJ said
“Upon the true construction of the subject, scope and purpose, a particular statute may establish a regulatory regime which gives an exhaustive measure of judicial review at the instance of competitors or other third parties.”
[36] They instanced as an example Alphapharm 49 FCR 250. Gaudron, Gummow and Kirby JJ held (194 CLR 247 at [52]) that a person may be able to establish that he, she or it has standing to assert that a decision-maker failed to, or must, observe statutory limitations on his, her or its activity in respect of an interest that, as a matter of practical reality, is immediate, significant and peculiar to him, her or it. Their Honours held there that the person had standing to challenge the administrative decision because, in the market in which it operated, it was highly probable that, if the decision were acted on, the person's business would suffer severe detriment.
Consideration
I will recap some of the background. The applicant seeks to set aside three Initial Decisions of the Secretary to include medical devices on the Register. Two of the applications to include medical devices on the Register were brought by ITL. The ITL applications passed preliminary assessment and were not selected for audit. Consequently, the Secretary included those devices in the Register pursuant to s 41FF. The other application to include a medical device on the Register was brought by YES and it was selected for audit. After the auditing process, the delegate of the Secretary made a decision to include the medical device on the Register pursuant to s 41FI(2).
On 6 May 2024, the applicant requested the Minister to reconsider the Initial Decisions by which the three medical devices were registered. The Minister did not reconsider the Initial Decisions. Instead, the TGA responded to the applicant on 6 June 2024 denying that the applicant was a person whose interests were affected by the Initial Decisions. The applicant then applied to the Tribunal for review seeking to set aside the deemed confirmation of the Initial Decisions.
The respondent says that the applications for review should be dismissed for lack of standing because the applicant is not a person who is affected by the Initial Decisions under s 60(2) of the TG Act.
The first thing to take from the authorities referred to earlier in these reasons is that I must consider the question of whether the applicant is a person whose interests are affected by the Initial Decisions under s 60(2) by reference to a meaning of the phrase based on its context and the scope and purpose of the TG Act.
With respect to context, the interests affected in s 60(2) should be considered in the context of Part 4-5 and more particularly s 41FF(1) and s 41FI(2) under which the Initial Decisions were made to include the devices in the Register. I refer to the relevant provisions of Part 4-5 earlier in these reasons.
The Tribunal did not receive any evidence from either ITL or YES with respect to their applications, but it is not in dispute that the Secretary dealt with their applications in accordance with the process set out in Part 4-5 of the TG Act. Nor is there any dispute with respect to the facts set out in the chronology contained within the respondent’s submissions on dismissal for lack of jurisdiction dated 13 September 2024. Further, for the purpose of this dismissal application, I have accepted the facts in the material provided by the applicant, namely the three requests for reconsideration made by the applicant dated 6 May 2024 (including attachments), the three applications for review lodged with the AAT on 18 July 2024 (including attachments), the letter of advice from Mr Allan Anforth AM to the applicant provided on 18 July 2024 and the statement of Mr Cameron dated 10 October 2024. Accordingly, I will consider the question of the applicant’s standing based upon the facts derived from those sources as set out below.
The process of registration began with applications being made by ITL and YES to the Secretary under s 41FC for the relevant medical devices to be included in the Register, as Class IIa medical devices (hereinafter referred to as the Class IIa Medical Devices). ITL made two applications on 29 February 2024 and 25 March 2024. YES made its application on 12 March 2024. There was no requirement for any notification of those applications to the public or to persons (such as the applicant) recorded on the Register for similar devices. The Secretary received the applications and assessed them by reference to requirements set out in s 41FDB(2). The applicant was not entitled to be notified of the applications, nor was it entitled to be heard or in any way involved in the assessment.
The Secretary was satisfied of the s 41FDB(2) requirements in relation to the three applications and they each passed preliminary assessment by operation of s 41FDB(3). The application brought by YES was then selected for audit under s 41FH. The medical devices which were the subject of the other two applications (not selected for audit) were included in the Register pursuant to s 41FF(1) and certificates were provided by the Secretary to ITL as the successful applicant. The TGA maintains a public summary of entries in the Register which records the inclusion of the two products categorised as Class IIa medical devices sponsored by ITL with a start date on 1 March 2024 and 22 April 2024.
Pursuant to s 41FH(2), the Secretary gave YES a written notice which informed it of the audit and which required it to provide certain information and documents relevant to the audit. The application was selected for audit due to concerns regarding the device’s class IIa.[31] After the auditing process, the Secretary made a decision to include this medical device in the Register pursuant to s 41FI(2), which requires the Secretary to be satisfied as to all aspects considered in the audit. There is no obligation on the Secretary to provide reasons for a positive decision to include a medical device in the Register after an auditing process. However, if the decision had been negative, reasons for the decision would have had to be given pursuant to s 41FJ(b). The public summary records the inclusion of this product as a Class IIa medical device sponsored by YES with a start date on 15 March 2024.
[31] Respondent’s submissions on dismissal for lack of jurisdiction dated 13 September 2024, 6 [16].
The applicant only became aware of the approval of the Class IIa Medical Devices once it was made public by virtue of their inclusion in the public summary on 1 March, 15 March and 22 April 2024. It was not possible for the applicant to have any knowledge of the applications made by ITL or YES prior to the inclusion in the public summary because such information is considered ‘commercial-in-confidence’ by the TGA.[32] The effect of Part 4-5 is that the applicant had no involvement in the process of determining the three applications for a medical device to be included in the Register.
[32] Request for reconsideration dated 6 May 2024 at page 7.
It is my view that the lack of third-party involvement in the process of registration under Part 4-5 indicates that the applicant is not a person whose interests are affected by the Initial Decisions for the purposes of s 60(2) and therefore indicates that the applicant has no standing to challenge the inclusion of a medical device in the Register. When considering the issue of standing for the purposes of s 60(2), it is important to remember the point made by Davies J in the Alphapharm case that the process of reconsideration of the initial decision by the Minister is part of the process of administrative decision making.[33] Part 4-5 contains no requirement for the provision of an opportunity for any third parties to be heard upon an application for registration.[34] Applications to be included in the Register are not advertised. The applicant was not even aware that the three relevant applications had been made until after they had been assessed and determined and the medical devices had been included in the Register. The process of assessment in accordance with the requirements in s 41FDB(2) is undertaken by experts on a confidential basis without any input from persons already included on the Register or any other third parties. It would be an odd result if those third parties, having been excluded from the decision-making process, could later challenge that decision as part of the administrative process. Further, it would not be consistent with a system of efficacy or the timely availability of therapeutic goods which are objects of the TG Act.[35] The Alphapharm case supports my view.
[33] Alphapharm (n 4) 260B.
[34] Ibid per Gummow J at 280A.
[35] Ibid per Gummow J at 280C – D.
The applicant has provided a significant amount of evidence to support its contention that the Initial Decisions to include the medical devices in the Register as Class IIa are wrong. That evidence is based upon the expert opinion of Professor Claire Rickard that the Class IIa Medical Devices should be classified as Class III. The applicant contends that because the medical devices of the applicant and the Class IIa Medical Devices are functionally equivalent and clinically interchangeable then they should all be classified at the same level, namely Class III. The applicant also relies upon decisions under s 60(2) dealing with similar facts in 2015 by the Minister (or a delegate) to reconsider an initial decision upon the request of the applicant who was found to have standing. The applicant says that it successfully appealed under s 60(2) against a decision to include a product in the Register as Class IIa. The applicant submits on the grounds of consistency in decision making that it should have standing to challenge the Initial Decisions made in this case and that they were wrong. The applicant surmises that the decisions to include the Class IIa Medical Devices in the Register as Class IIa were based upon a publication from the TGA Medical Devices Surveillance Branch dated 29 August 2023 which has since been taken down from the TGA website. In that publication, the TGA provided guidance on applying the classification rules and said that it considers that a sterile flush syringe (a product similar to the applicant’s) will be Class IIa.[36] The applicant says that this ‘provides a valuable insight into what appears to be different interpretations of the classification rules by Delegates over time.’[37]
[36] Request for reconsideration dated 6 May 2024, Attachment 1.
[37] Ibid 4-5.
The evidence and the submissions from the applicant set out in the above paragraph go to the question as to whether the decisions to include the Class IIa Medical Devices in the Register as Class IIa were the correct or preferable decisions, rather than whether the applicant has standing. Further, whilst I am entitled to consider the approach to decision making of the respondent and the Minister in earlier decisions so as to achieve consistency, I am not bound by them. The applicant clearly opposes the Initial Decisions and considers that they were wrong, but the question of standing depends upon the interests of the applicant and how they are affected by the Initial Decisions, not whether there are strong grounds to oppose the decisions. Mere opposition to the inclusion of the Class IIa Medical Devices in the Register will not give the applicant a sufficient interest for the purposes of s 60(2).[38]
[38] Alphapharm (n 4) at 280B; Right to Life (n 17) 84 – 5.
I accept that the applicant’s evidence goes beyond mere opposition to the Initial Decisions and I now turn to consider that evidence. The evidence from Mr Cameron firstly and predominantly goes to the difference in both costs incurred and prices charged in relation to pre-filled saline flush syringes depending on whether they are classified as Class IIa or Class III. Those syringes that have a classification less than Class III, such as the Class IIa Medical Devices, are sold at a lower price because the regulatory and manufacturing costs for them are lower, despite being functionally equivalent and clinically interchangeable medical devices. Mr Cameron says that this establishes an ‘unfair market’ between the Class IIa Medical Devices and those classified as Class III.[39]
[39] Statement of Mr Hugh Cameron dated 10 October 2024 at [20].
This ‘unfair market’ affects the commercial interests of the applicant because its competitors will derive an advantage from selling their product at a lower price compared to the applicant. If the Class IIa Medical Devices remain on the Register as Class IIa products, then the applicant may suffer financial loss because it would have to reduce the price of its Class III medical devices in order to compete. However, if the only interest of the applicant which is affected is a commercial or economic interest, then the Alphapharm case is authority that this will not be a sufficient interest for the purposes of s 60(2):
The interest which SmithKline 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).[40]
[40] Alphapharm (n 4) per Davies J at 263F-G.
The next concern expressed by Mr Cameron is that the lesser classification of the Class IIa Medical Devices means that those products are brought to market with a lower safety profile than the applicant’s medical devices which are included in the Register as Class III. He contends that if Class III is warranted for the applicant’s medical devices for public health and safety reasons, then it is also warranted for the Class IIa Medical Devices.[41] The potential impact on public health and safety if the Class IIa Medical Devices remain classified as Class IIa was expanded upon in the applicant’s request for reconsideration dated 6 May 2024. The applicant provided details of the clinical risks to public health associated with the use of pre-filled syringes and says that those risks would be increased because Class IIa Medical Devices attract less regulatory scrutiny resulting in potential hazards at the patient level. The need for strong regulations and audits (associated with Class III medical devices) is supported by the expert opinion from Professor Claire Rickard.
[41] Statement of Mr Hugh Cameron dated 10 October 2024 at [20].
The health and safety concerns expressed by the applicant are the very concerns that would have been considered and assessed when making the Initial Decisions under the statutory regime in Part 4-5. The interest of the applicant affected by the potential health and safety impacts are no greater than any other member of the public. I reject the applicant’s contention of a sufficient interest arising from concerns of a potential impact on public health and safety. Such an interest is not sufficient for the purposes of s 60(2) for the reasons expressed by Burchett J in the Alphapharm case:[42]
It was the Secretary who had the statutory responsibility to ensure that full weight was given in the making of the decision to questions 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.
[42] Alphapharm (n 4) at 266A.
Consequently, the respondent in the Alphapharm case lacked standing to challenge the initial decision. The respondent’s lack of standing was consistent with it having ‘no right under the statute to be heard upon the original consideration of the matter’,[43] which applies with equal force to the applicant in the present case.
[43] Ibid at 266D.
The final concern expressed by Mr Cameron to the Class IIa Medical Devices remaining on the Register in Class IIa was that adverse events caused by the use of such products would incorrectly involve the applicant’s medical devices in any investigation and potential recalls.[44] A similar submission (rejected for lack of evidence) was made in the Alphapharm case, namely that if it turned out that Alphapharm’s generic product was placed on the market and was unsafe, that fact would be likely to reflect adversely upon SmithKline’s product.[45]
[44] Statement of Mr Hugh Cameron dated 10 October 2024 at [21] – [26].
[45] Alphapharm (n 4) at 258F.
Mr Cameron explained in his statement that there was a previous incident when the applicant incurred time and expense because of an investigation by the respondent (or the TGA) following the death of a person in Queensland, and multiple reported infections, from contaminated saline. Mr Cameron suggested that the respondent (or the TGA) incorrectly identified the applicant’s product for investigation because it was similar to another manufacturer’s product referred to as Product C. The respondent responded to this suggestion by Mr Smith stating that the TGA received information that one of the applicant’s syringes was or may have been used in the care of a patient who became infected. An investigation followed which concluded that it was unlikely that the applicant’s product was associated with the infection. Mr Smith stated that it was unlikely that the applicant’s product was misidentified and that the TGA never received any report that Product C caused an infection.
The evidence from Mr Cameron does not support the applicant’s contention that its interests were affected by the inclusion on the Register of the Class IIa Medical Devices. The evidence does not support a finding that, if the Class IIa Medical Devices remain on the Register, there will likely be a negative impact on public health and safety, nor that there is likely to be an investigation in which the applicant may become involved. Even if the applicant were to become embroiled in an investigation by the TGA arising from another similar product, that investigation arises from a statutory scheme which entitles the TGA to investigate. The power to investigate is part of the system of controls over medical devices as provided for in the objects of the TG Act in s 4(1)(a). It may be in the applicant’s commercial interests to avoid becoming embroiled in such an investigation, but it is difficult to see that the TG Act would recognise such an interest when the power to investigate is a legitimate part of the statutory scheme and is consistent with the statutory objectives. As Davies J in the Alphapharm case said:[46]
… the review, which forms part of the process of administrative decision-making, is provided to promote the achievement of the objects of the statute.
[46] Ibid at 260 – 1.
The interest of the applicant to avoid a potential investigation is indeed in conflict with the interests which the TG Act promotes.
Further, the concern expressed by Mr Cameron is too remote and is based upon an unlikely “possibility” of a future misidentification of product by the respondent. There is no immediate effect on the applicant because there is no current investigation. There is no evidence that the TGA is considering making such an investigation, nor that it would improperly embroil the applicant or lead to its medical devices being recalled. The contended effect on the applicant is speculative and would appear to be based on an asserted risk of a future investigation in which the respondent (or TGA) incorrectly identifies the applicant’s medical devices for investigation. There is no proper foundation for the concern expressed. I find that this concern relates to a very remote possibility which is not ‘as a matter of practical reality … immediate, significant and peculiar to’[47] the applicant.
[47] Bateman’s Bay Local Aboriginal Land Council v The Aboriginal Community Benefit Fund (1998) 194 CLR 247 at [52]; and Australian Vaccination-Risks Network Inc v Secretary, Department of Health [2022] FCAFC 135; (2022) 292 FCR 1 at [36].
The applicant relies upon SmithKline Beecham[48] and adopts the finding of Weinberg J that the assumed facts in that case went well beyond those established in the Alphapharm case. I do not consider in the present case that the Alphapharm case can be distinguished on its facts. The applicant has not established ‘a real chance that it may be significantly prejudiced if [the Class IIa Medical Devices] remains registered.’[49]
[48] SmithKline Beecham (n 22) at [92].
[49] Ibid.
I note further that the issue in SmithKline Beecham[50] was whether the applicant had standing to seek judicial review and that Weinberg J accepted that there was doubt as to whether the applicant had standing under s 60(2) to seek merits review[51] and it can therefore be distinguished on that basis.
[50] Ibid.
[51] Ibid at [105]
The applicant relied upon amendments made to the TG Act since the Alphapharm case by which ss 60(2AA) to (2E) were inserted. I note first that s 60(2) has not been amended in any material way and that the objects of the TG Act remain the same. The amendments relied upon by the applicant do not relate to decisions to register medical devices. They relate to different types of initial decisions and I do not consider that they impact upon the statutory interpretation of s 60(2). The fact that s 60(2) was not amended implies that Parliament endorsed the courts’ construction of s 60(2) in the Alphapharm case.[52]
[52] Michelle Sanson, Statutory Interpretation (Oxford University Press, 2nd ed, 2017) at 31. See also Dennis Pearce, Statutory Interpretation in Australia (LexisNexis Australia, 10th ed, 2024) at [3.61].
As Davies J said in the Alphapharm case, a factor relevant to the question of standing is the extent of the affection of the person’s interest. It will be a question for each case whether the extent of the affection of the interest asserted is sufficient as a matter of practical reality in the circumstances to qualify the person asserting it to challenge the decision or decisions complained of. That question must be answered in the context of the legislation within the framework of which the decision is made. By reference to the TG Act, in my view the applicant does not qualify as a “person whose interests are affected” under s 60(2).
It follows that the applicant does not have standing to challenge the Initial Decisions. I am satisfied on that basis that the applications brought by the applicant for review have no reasonable prospect of success. The Tribunal dismisses the applications under s 101(1)(b) of the ART Act.
The Tribunal dismisses the applications for review under s 101(1)(b) of the ART Act.
85. I certify that the preceding 84 (eighty-four) paragraphs are a true copy of the reasons for the decision herein of Deputy President Britten-Jones.
..................[sgd]......................................................
Associate
Dated: 10 January 2025
Date(s) of hearing: 27 November 2024 Applicant’s Counsel: Mr Allan Anforth AM Respondent’s Counsel: Mr Bora Kaplan and Ms Callista Harris
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