FEDERAL COURT OF AUSTRALIA

Secretary, Department of Health and Aged Care v M House Pty Ltd [2024] FCAFC 71

ORDERS

THE COURT ORDERS THAT:

1.    The appeal is allowed.

2.    The orders made by the primary judge on 24 July 2023 are set aside.

3.    The originating application filed on 2 September 2022 is dismissed.

4.    The respondent is to pay the costs of the proceeding and of the appeal.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

O’CALLAGHAN AND MCELWAINE JJ:

INTRODUCTION

1    The Secretary of the Department of Health and Aged Care (the appellant) appeals from a decision of a judge of this court upholding a contention of M House Pty Ltd (the respondent) that a decision of the appellant’s delegate to release certain information under s 61(5C) of the Therapeutic Goods Act 1989 (Cth) (the Act) was not authorised by that sub-section and should therefore be quashed. See M House Pty Ltd v Secretary, Department of Health and Aged Care [2023] FCA 76 (J).

2    The Therapeutic Goods Administration (the TGA), which is part of the Department of Health and Aged Care (the Department), undertook in late 2020 and early March 2021 a “post-market review” of all face masks included in the Australian Register of Therapeutic Goods, including face masks imported by the respondent. (At that time, of course, face masks were in high demand because of the spread of the Corona Virus).

3    As part of the post-market review, officers of the Department obtained two different samples of a surgical face mask product that had been supplied to the market by the respondent and subsequently acquired by the Commonwealth for the purposes of holding the product in the National Medical Stockpile. Officers of the Department then conducted testing upon masks from each sample.

4    Under s 63 of the Act, the Governor-General may make regulations prescribing matters “necessary or convenient to be prescribed for carrying out or giving effect” to the Act. Such regulations may “provide for the procedures to be followed by the Department in the sampling and testing of therapeutic goods” (see s 63(2)(d)). The Act does not define “sampling” or “testing”.

5    Such regulations include those contained in Pt 5 of the Therapeutic Goods Regulations 1990 (Cth) (the Regulations). Part 5 is headed “Examination, testing and analysis of goods”.

6    The testing conducted in this case was conducted for the purpose of assessing whether the masks from each sample complied with the “essential principles” set out in Sch 1 to the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) (the Medical Devices Regulations). Those essential principles concern the safety and performance characteristics of medical devices, including their quality, safety and efficacy.

7    In taking the samples and conducting the testing in this case, the officers of the Department did not exercise powers under or in accordance with Pt 5 of the Regulations, but instead acted in a non-statutory executive capacity.

8    A delegate of the Secretary of the Department then decided under s 61(5C) of the Act to release to the public, certain information relating to the testing of the masks (Information): J [32].

9    The Information was released in accordance with that decision by way of publication on the TGA’s website: J [2], [33].

10    Section 61(5C) of the Act provides that “[t]he Secretary may release to the public therapeutic goods information of a kind specified under subsection (5D)”. Subsection (5D) states that “[t]he Minister may, by legislative instrument, specify kinds of therapeutic goods information for the purpose of subsection (5C)”.

11    One such legislative instrument is the Therapeutic Goods Information (Laboratory Testing) Specification 2017 (Cth) (the Specification).

12    Schedule 1 to the Specification is a table which sets out the kinds of therapeutic goods information that may be released to the public under s 61(5C) of the Act, including “description of samples of therapeutic goods”, “test description” and “test results”.

13    The principal question before the primary judge was whether the delegate’s decision to release the Information to the public was authorised by s 61(5C) of the Act: J [3].

14    The answer to that question turns on a question of statutory construction, namely “whether the references to ‘samples’ and ‘tests’ within Schedule 1 of the [Specification], when read in the context of s 61(5C) and (5D) of the Act, encompass sampling and testing undertaken in the exercise of the [Secretary’s] alleged non-statutory capacity to determine non-compliance with the essential principles”: J [111].

15    The primary judge held that references to “samples” and “tests” in Sch 1 to the Specification do not encompass sampling and testing conducted outside of the regime for sampling and testing prescribed in Pt 5 of the Regulations (see J [73]–[74], [118]–[119]), in substance because the Regulations cover the field.

16    Accordingly, the primary judge made an order quashing the decision. He also made consequential orders requiring the appellant to publish certain statements about the outcome of the proceeding: see J [133].

17    By a single ground of appeal, the appellant contends that the primary judge erred in so finding and making those orders because:

(1)    the construction of the words “sample” and “tests” that his Honour preferred is not supported by the text, context or purpose of the Specification.

(2)    the words “sample” and “test” are not meaningfully defined in the Regulations, and they are thus to be given their natural and ordinary meaning;

(3)    the natural and ordinary meaning of those words does not include any limitation that a “sample” or “test” only be conducted in accordance with Pt 5 of the Regulations;

(4)    Part 5 of the Regulations does not exhaust, or purport to exhaust, the ways in which samples might be obtained, or tests might be conducted, by officers of the Department;

(5)    the purpose of the Specification is to increase transparency; not to protect the reputations of “industry participants”, and that purpose is best achieved by reading the terms “sample” and “test” as encompassing all the testing activities of the TGA, not just those conducted under Pt 5 of the Regulations.

(6)    if Parliament had intended the words “sample” and “test” to mean only “sample and test within the meaning of Pt 5 of the Regulations”, it would have said so.

18    The respondent contended that the reasoning and decision of the primary judge was correct.

19    For the reasons set out below, the submissions of the appellant are to be accepted. Contrary to the conclusion reached by the primary judge, the question of statutory construction is to be answered in the affirmative.

20    The respondent relied on a notice of contention, contending that the orders made by the primary judge should be affirmed on grounds other than those relied on by the primary judge. Ground 1 of the notice of contention raised the same point of statutory construction raised by the appellant’s ground of appeal, so it is not necessary separately to consider it under the rubric of the notice of contention.

21    Ground 2, which was only faintly pressed, was that the published information was not “therapeutic goods information” as defined in s 61(1) of the Act.

22    Ground 3 was that the decision to publish the information was legally unreasonable, in circumstances where the test results were applicable only to the samples tested; and the procedure for sampling and testing set down in regs 25-29 of the Regulations was not followed.

23    In our view, grounds 2 and 3 are without merit, for reasons set out below.

24    The appeal will thus be allowed, the orders made by the primary judge be set aside and, in lieu of those orders, it will be ordered that the originating application for judicial review be dismissed with costs.

THE STATUTORY CONSTRUCTION QUESTION

25    The appellant’s ground of appeal is that the primary judge:

(a)    erred in construing the words “sample” and “test” in Sch 1 to the Specification as referring only to sampling and testing under Pt 5 of the Regulations (and not to other sampling and testing, including sampling and testing in the exercise of a non-statutory executive power or capacity); and

(b)    therefore erred in concluding that s 61(5C) of the Act did not authorise the decision made by a delegate of the appellant on 4 August 2022 to release the information relating to batch numbers LX202010 and N/B-BTWT260031 of ARTG 337122 (Softmed 3PLY earloop disposable face mask).

26    It was common ground that the primary judge’s framing of the construction question as set out above at [14] was correctly formulated — that is:

whether the references to “samples” and ‘tests’ within Schedule 1 of the Specification, when read in the context of s 61(5C) and (5D) of the Act, encompass sampling and testing undertaken in the exercise of the Secretary’s alleged non-statutory capacity to determine non-compliance with the essential principles.

27    Having regard to the text, context and purpose of the Specification however, the appellant submitted that the primary judge reached the wrong conclusion on that question. For the reasons that follow, we agree.

Principles of statutory construction

28    The general principles relating to the interpretation of primary legislation equally apply to subordinate legislation, and there was no dispute about them.

29    To determine the meaning of a statutory provision, the starting point is the text of the statute considered in light of its context and purpose. The statutory context of regulations includes, of course, the Act under which the regulations were made. Context should be regarded at the first stage and not some later stage, and should be regarded in its widest sense, including by reference to legislative history and extrinsic material. See SZTAL v Minister Immigration and Border Protection (2017) 262 CLR 362 at 368 [14] (Kiefel CJ, Nettle and Gordon JJ); ENT19 v Minister for Home Affairs (2023) 97 ALJR 509; [2023] HCA 18 at [86]–[87] (Gordon, Edelman, Steward and Gleeson JJ).

30    As Gordon, Edelman, Steward and Gleeson JJ recently explained in ENT19 at [87]:

The context of the words, consideration of the consequences of adopting a provision’s literal meaning, the purpose of the statute and principles of construction may lead a court to adopt a construction that departs from the literal meaning of the words of a provision. One such principle is that legislation must be construed on the prima facie basis that its provisions are intended to give effect to harmonious goals. As expressed by Gageler J in SAS Trustee Corporation v Miles, “statutory text must be considered from the outset in context and attribution of meaning to the text in context must be guided so far as possible by statutory purpose on the understanding that a legislature ordinarily intends to pursue its purposes by coherent means”. Where conflict appears to arise in construing an Act, “the conflict must be alleviated, so far as possible, by adjusting the meaning of the competing provisions to achieve that result which will best give effect to the purpose and language of those provisions while maintaining the unity of all the statutory provisions”, and this “will often require the court ‘to determine which is the leading provision and which the subordinate provision, and which must give way to the other’”. Ultimately, the task in applying the accepted principles of statutory construction is to discern what Parliament is to be taken to have intended.

(Footnotes omitted).

The statutory context

31    It is helpful to set out in some detail the applicable statutory framework as it existed at 4 August 2022, being the date the delegate made the decision to release the information under s 61(5C) of the Act.

Objects of the Act

32    The starting point is the Act. The objects of the Act are set out in s 4, and include providing “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 used in Australia, whether produced in Australia or elsewhere”: s 4(1)(a).

33    “Therapeutic goods” are relevantly defined to include “medical devices”: s 3. Where therapeutic goods are medical devices, the reference to their “efficacy” in the objects is a reference to the performance of the devices as the manufacturer intended: s 4(1A).

34    The parties did not dispute that the surgical face mask the subject of this proceeding was a “medical device”, as that term is defined in s 41BD of the Act. See, in particular, s 41BD(1)(a)(i), which defines a medical device to include an “article … intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of … prevention … of disease … and that does not achieve its principal intended action in or on the human body, by pharmacological, immunological or metabolic means”.

Medical devices and the “essential principles”

35    Chapter 4 of the Act (ss 41B to 41MR) deals with medical devices. The purpose of Chapter 4, as set out in its first provision under the heading “General” (s 41B), is to ensure the safety and satisfactory performance of medical devices, which it is said to do 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.

36    Under s 41BA(a), one of the requirements for medical devices is expressed to be “essential principles (that are about the safety and performance characteristics of medical devices)”. Section 41CA stipulates that the regulations may set out requirements for medical devices and that these requirements are to be known as the “essential principles”.

37    The essential principles made pursuant to s 41CA of the Act are set out in Sch 1 to the Medical Devices Regulations. While it is not necessary to outline the essential principles in any detail, it is sufficient for present purposes to note that they deal with such matters as the need for:

(a)    the use of medical devices not to compromise health and safety (Sch 1 cl 1);

(b)    the design and construction of medical devices to conform with safety principles (Sch 1 cl 2); and

(c)    medical devices to be suitable for their intended purpose (Sch 1 cl 3).

38    Section 41BH(1) of the Act makes clear that, for the purposes of Chapter 4, a medical device complies with the essential principles if and only if it does not contravene any of the essential principles. Chapter 4 also contains a number of civil penalty and criminal offence provisions which relate to non-compliance with essential principles. Sections 41MA and 41MAA, by way of example, establish criminal offences and civil penalties for importing, supplying or exporting a medical device that does not comply with essential principles.

Inclusion of medical devices in the Register

39    It is not in dispute that, at all times, the medical device in this case was included on the Australian Register of Therapeutic Goods (Register). In accordance with s 9A of the Act, the Register is maintained by the Secretary “for the purpose of compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans”.

40    Division 1 of Pt 4-5 in Chapter 4 deals with applications for the inclusion of medical devices on the Register. A person may make an application to the Secretary for a kind of medical device to be included in the Register: s 41FC(1). Under s 41FD, the applicant must certify, among other things, that:

(a)    the device complies with the essential principles (s 41FD(d)); and

(b)    the applicant “has available sufficient information to substantiate that compliance with the essential principles” or “has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations” (s 41FD(e)).

41    The Act also establishes criminal offences and civil penalties in relation to making false and misleading statements in connection with certification or purported certification under s 41FD: see ss 41FE and 41FEA.

42    Division 2 of Pt 4-5 in Chapter 4 deals with the conditions for inclusion of medical devices on the Register. The inclusion of a kind of medical device in the Register is subject to a number of automatic conditions as set out in s 41FN, including that:

(a)    the person in relation to whom the kind of medical device is included in the Register will deliver a reasonable number of samples of the kind of device if the Secretary so requests: s 41FN(2); and

(b)    the person to whom the kind of medical device relates, at all times, has available sufficient information to substantiate compliance with essential principles: s 41FN(3)(a)(i).

43    Part 4-6 in Chapter 4 deals with suspension and cancellation of inclusions in the Register. Under s 41GA(1)(b), the Secretary may suspend a kind of medical device from the Register if the Secretary is satisfied that it is likely that there are grounds for cancelling the entry of the kind of device in the Register under Division 2 of Pt 4-6 (subject to certain exceptions which are not presently relevant). Relevantly:

(a)    under s 41GL, the Secretary may cancel the entry of a kind of device from the Register if, among other things, the Secretary is satisfied that a statement made in or in connection with the application for including the kind of device in the Register, or the certification or purported certification under s 41FD relating to the application, was false or misleading in a material particular: s 41GL(e);

(b)    under s 41GN(1), the Secretary may cancel the entry of a device from the Register if, among other things:

(i)    the person in relation to whom the kind of medical device is included in the Register refuses or fails to comply with a condition to which that inclusion is subject: s 41GN(1)(b);

(ii)    the Secretary is satisfied that the safety or performance of the kind of device is unacceptable: s 41GN(1)(e); or

(iii)    the Secretary is satisfied that any certification, or part of a certification, under s 41FD in relation to the application for inclusion of the kind of device in the Register is incorrect, or is no longer correct, in a material particular: s 41GN(1)(e).

44    Chapter 4 of the Act also sets out various criminal offences and civil penalties for importing, supplying or exporting medical devices that are not included on the Register: see, for example, ss 41MI and 41MIB.

Testing and sampling under Pt 5 of the Regulations

45    Under s 63 of the Act, the Governor-General may make regulations prescribing matters “necessary or convenient to be prescribed for carrying out or giving effect” to the Act. Such regulations may “provide for the procedures to be followed by the Department in the sampling and testing of therapeutic goods” (see s 63(2)(d)). Section 63(2)(g) also provides that the regulations may “make provision for the testing of therapeutic goods … by the Department at the request of persons”. The Act does not define “sampling”, “sample”, “testing”, or “test”.

46    Regulations made under s 63(2)(d) include those in Pt 5 of the Regulations. Part 5 is headed “Examination, testing and analysis of goods”. The primary judge summarised the procedures for testing and sampling set out in Pt 5 at J [59]–[61] as follows:

… Part 5 of the Regulations is headed “Examination, testing and analysis of goods” and comprises regs 23-33.

Regulation 24 which is the first substantive provision in Pt 5 of the Regulations is titled “Authorised officer – powers and duties” and relevantly provides:

(1)    An authorised officer may, during normal business hours:

(a)    for the purpose of exercising the powers and performing the duties of an authorised officer under this regulation, enter the premises of a licence holder, manufacturer in respect of whom a conformity assessment certificate has been issued, or wholesaler on which therapeutic goods are kept for supply; and

(b)    inspect the place at which those goods are kept; and

(c)    take samples of those goods; and

(d)    ask the owner of therapeutic goods, or the person apparently in charge of those goods, for information relevant to the manufacture and testing of those goods.

Part 5 sets out the following procedures applicable to testing:

(a)    Pursuant to reg 25(3), an “official analyst” may: ask an authorised officer to take samples of therapeutic goods (reg 25(3)(a)); determine the tests that are to be performed on “a sample taken under paragraph (a) or delivered under paragraph [sic] 28(5)(h) or subsection 41FN(2) of the Act” (reg 25(3)(b)); or “nominate an analyst or official analyst to be the responsible analyst for a sample taken under paragraph (a) or delivered under paragraph [sic] 28(5)(h) or subsection 41FN(2) of the Act” (reg 25(3)(c)). The reference in reg 25(3)(b) to samples delivered under ss 28(5)(h) and 41FN(2) of the Act is a reference to the provision of samples upon request by the Respondent pursuant to a condition imposed at the point of the therapeutic good or medical device’s original registration. Section 28(5)(h) sets out the conditions applicable upon therapeutic goods that are not medical devices. Section 41FN(2), which is discussed above at [44], sets out the conditions applicable upon registration of medical devices.

(b)    Regulations 25(4)-(5) provide:

(4)    The tests determined under paragraph (3)(b), by an official analyst, for the following matters must be tests covered by regulation 28:

(a)    determining whether particular therapeutic goods (other than medical devices) are goods that conform with a standard applicable to the goods;

(b)    determining whether a particular kind of medical device complies with the applicable provisions of the essential principles.

(5)    The tests determined under paragraph (3)(b), by an official analyst, for a matter not covered by subregulation (4), are the tests that the official analyst considers appropriate.

(c)    The tests for determining whether a therapeutic good other than a medical device conforms with a standard applicable to the goods are set out in reg 28(1). The tests for determining whether a particular kind of medical device complies with the essential principles are set out in reg 28(2). Those tests are as follows:

(a)    a test specified in a medical device standard or conformity assessment standard for the kind of device;

(b)    a test accepted for the purpose of issuing a conformity assessment certificate in respect of the kind of device;

(c)    a test required under paragraph 41FO(2)(d) of the Act as a condition of inclusion of the kind of device in the Register;

(d)    any other suitable test that the Secretary requires to be carried out in respect of the kind of device for the purpose of demonstrating compliance with the applicable provisions of the essential principles.

(d)    Where an authorised officer takes a sample, reg 26 prescribes a procedure for samples to be taken. Amongst other things, the authorised officer must:

(i)    make the required notifications, including to the sponsor of the goods (regs 26(1)(a) and (b));

(ii)    forward the sample to the relevant laboratory (reg 26(1)(c)); and

(iii)    take various precautions – namely ensuring the samples are appropriately fastened and sealed and stored and transported in accordance with the instructions specified on the label of the goods (r 26(2)).

(e)    When a sample of therapeutic goods is delivered under s 28(5)(h) or 41FN(2) of the Act, reg 26A prescribes procedures for ensuring the integrity of the sample has been maintained.

(f)    On receiving a sample at a Departmental laboratory, a “samples officer” must determine whether the sample is appropriately fastened and sealed and, if so, store the sample under their control in conditions that are secure and appropriate to the goods: reg 27(1).

(g)    The responsible analyst must, as soon as practicable, collect the sample from the samples officer and arrange for an analysis of the sample by performing the tests determined under reg 25(3)(b) to establish:

(i)    the quantity and quality of goods comprising the sample (reg 27(2)(a)(i)); and

(ii)    “any other matter relevant to determining whether […] the goods from which the sample was taken comply with the [essential principles]” (reg 27(2)(a)(ii)(B)).

(h)    A responsible analyst “must” issue a certificate setting out the results of the reg 27(2) analysis and examination (reg 29(1)). If the certificate includes a compliance determination to the effect that the goods (from which the sample was taken) do not comply with the essential principles, then the certificate must be accompanied by the appropriate notice (regs 29(4), 29(4A)) which states, among other things, that the person may ask for a review of the results pursuant to reg 30. Reg 29(5) provides that in proceedings under the Act or Regulations, a certificate issued under reg 29(1) is, in the absence of contrary evidence, “conclusive proof” of the matters set out in the certificate.

(i)    Regulation 30 prescribes a detailed regime for review of a compliance determination.

(j)    Regulation 31 provides that “[i]f a sample of therapeutic goods is taken by an authorised officer, the Commonwealth is liable to pay the owner of the goods from which the sample was taken an amount equal to the value of any part of the sample removed by the authorised officer.”

(k)    Regulation 32 prescribes various criminal offences in the case of interference with an authorised officer in the execution of his or her powers under the Regulations.

Further testing and sampling provisions in the Act and Regulations

47    Part 6-2 in Chapter 6 of the Act deals with entry, searches and warrants.

48    Importantly, there are a number of provisions in Pt 6-2 which empower “authorised persons” to enter premises and “inspect, examine, take measurements of, conduct tests on or take samples of any therapeutic goods on the premises or any thing on the premises that relates to any therapeutic goods” (emphasis added). See, for example, ss 46, 46A(1)(b), 47, 48(1)(b).

49    Outside of Pt 5, the Regulations also include further provisions which enable officers of the Department to conduct tests or take samples. For example, reg 12AC(1)(c), under the heading “Powers of authorised officers in relation to goods imported etc for experimental uses”, relevantly provides that an authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or item 3 of the table in Schedule 5A, “inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial” (emphasis added).

Release of “therapeutic goods information” relating to tests and samples

50    Section 61 of the Act confers various powers on the Secretary to release “therapeutic goods information”. “Therapeutic goods information” is defined in s 61(1) to mean:

information in relation to therapeutic goods that is held by the Department and relates to the performance of the Department’s functions (including functions relating to the EC Mutual Recognition Agreement, the EFTA Mutual Recognition Agreement or the Australia-UK Mutual Recognition Agreement).

51    The reference to “the Department” is to the Department of State of the Commonwealth that is administered by the responsible Minister (see Acts Interpretation Act 1901 (Cth) s  19A). There is no short form description of the Department’s functions in the Act. They are multifarious and set out prescriptively in the 10 Chapters of the Act. Self-evidently the Department will acquire and hold a considerable amount of information relating to the performance of its functions. Some will be held as the result of the exercise of specific coercive powers, such as those in Part 6-1A, including by written notice to produce (s 45AB of the Act) or by exercising the right of entry and search of premises (s 46 of the Act). Other information may be obtained in consequence of the making of an application to the Secretary that a device be included in the Register under Pt 4-5 of the Act. Or, as in this case, information may be gathered less formally in the ordinary administration of the Act by humans who make inquiries and observations, obtain devices and undertake testing and sampling.

52    The Act draws a distinction in s 61 that should be mentioned. Section 61(5A) provides that “[t]he Secretary may release to the public therapeutic goods information relating to any decision or action taken under this Act or the regulations.” This power in terms is concerned with the release of information held by the Department in consequence of action that is taken by its officers in the exercise of specific powers to obtain information or where information is required to be supplied, such as upon an application for the inclusion of a device in the Register.

53    In this case the Secretary relies on s 61(5C) as the relevant power to release therapeutic goods information, which provides that “[t]he Secretary may release to the public therapeutic goods information of a kind specified under subsection (5D)”. Subsection (5D) states that “[t]he Minister may, by legislative instrument, specify kinds of therapeutic goods information for the purpose of subsection (5C)”. These provisions are not in terms confined to the release of information that is held by the Department because the Act requires its provision, or as the result of the exercise of an information gathering power that the Act confers.

54    Each subsection of s 61 that permits the release of information has independent effect (s 61(12)) which does not leave room for the drawing of implications that one provision operates to limit the scope of another.

55    The relevant legislative instrument in question made pursuant to subsection (5D) is the Specification.

56    Schedule 1 to the Specification sets out the kinds of therapeutic goods information that may be released to the public under s 61(5C) of the Act, including “description of samples of therapeutic goods” both included and not included on the Register, “test description” and “test results”, as follows:

57    The word “sample” is defined in s 4 of the Specification to have the same meaning as given in the Regulations. The definition in the Regulations says that “sample includes part of a sample”: see reg 2. The term is not otherwise defined in the Regulations. The word “test” is not defined in the Specification or Regulations.

58    The “note” to s 4 of the Specification also states that “a number of expressions used in this specification are defined in the Act, including the following”, which are then listed.

Immunity from civil actions

59    The Act contains a general “immunity from suit” provision under s 61A(1), which provides that:

No civil action, suit or proceeding lies against:

(a)     the Commonwealth; or

(b)     a protected person;

in respect of loss, damage or injury of any kind suffered by another person as a result of anything done, or omitted to be done, by a protected person in relation to the performance or purported performance, or in relation to the exercise or purported exercise, of a protected person’s functions, duties or powers under this Act or the regulations.

60    For the purposes of s 61A, “protected person” is defined to mean:

(a)    the Minister;

(b)    the Secretary;

(c)    a person to whom powers or functions are delegated under subsection 57(1);

(d)    a member of a committee established under the Act or the regulations;

(e)    an authorised person in relation to a provision of the Act (other than s 61A);

(f)    an authorised officer (within the meaning of the regulations);

(g)    an authorised person (within the meaning of the regulations);

(h)    a person assisting a person referred to in paragraph (a), (b), (c), (d), (e), (f) or (g) in relation to the performance or exercise of their functions, duties or powers under the Act or regulations.

Consideration

“Test” and “sample” are not limited to their meaning in Pt 5 of the Regulations

61    The Specification is authorised by and made pursuant to s 61(5D) of the Act. It is not made under or subordinate to the Regulations. Rather, the Regulations and the Specification are separate legislative instruments made under different provisions of the Act which operate in parallel with one another. The arboreal analogy that was adopted by senior counsel for the appellant in oral argument was that the Specification and Regulations are each separate “branches” which stem from the “trunk” of authority that is the Act.

62    Absent any contrary intention, the expressions used in the Specification must therefore be given the same meaning as in the Act, in accordance with s 13(1)(b) of the Legislation Act 2003 (Cth). (See too the note to s 4 of the Specification which says that a number of expressions used in the Specification are defined in the Act).

63    Beyond adopting the inclusive definition of “sample” used in the Regulations, “test” and “sample” are not otherwise defined in the Specification. The text of the Specification therefore indicates that the words “sample” and “test” are to be given their natural and ordinary meaning, determined by reference to their meaning in the Act. Nothing in the text of the Specification itself indicates that those terms are to be limited to the meaning of “sample” and “test” conducted in accordance with Pt 5 of the Regulations.

64    The appellant submitted, and we agree, that this construction of “sample” and “test” in the Specification is confirmed by the wider statutory context and purpose canvassed in paragraphs [31] to [60] above.

65    It is true that this statutory context includes Pt 5 of the Regulations. And there is no dispute that the terms “sample” and “test” in the Specification would encompass samples obtained, and tests conducted, in accordance with Pt 5.

66    But the respondent contended that, pursuant to s 63(2)(d) of the Act, Pt 5 of the Regulations comprises “the procedures to be followed [by the Department] in the sampling and testing of therapeutic goods, for the purpose of determining non-compliance with standards in the Act”. In support of this submission, the respondent pointed to the “long lineage” of both the Regulations and its empowering provision. In the context of this legislative history, the respondent asserted that Parliament may realistically be taken to have intended that the regulations made under s 63(2)(d) would set out the only procedures for sampling and testing done in the exercise of powers and functions arising under the Act.

67    In our view, however, Pt 5 of the Regulations cannot, and does not, exhaust the ways in which samples might be obtained or tests might be conducted by officers of the Department.

68    As the primary judge found, Pt 5 only applies in limited circumstances, namely in relation to samples that are obtained: (i) by exercise of coercive powers by an “authorised officer” under reg 24 of the Regulations, or (ii) by the delivery of samples in accordance with a request by the Secretary under s 41FN(2) or s 28(5)(h) (being the equivalent provision to s 41FN(2) but in respect of therapeutic goods other than medical devices) of the Act: J [85]–[87].

69    The respondent submits that the primary judge was wrong to so conclude because reg 24 addresses the “most likely” circumstance where an authorised officer enters premises in order to take a random sample of goods from a licence holder, manufacturer or wholesaler having been requested to do so by an official analyst under reg 25(3)(a), and that Pt 5 should be construed as applicable to samples taken by an authorised officer at the request of an official analyst in the exercise of other coercive powers such as reg 12AC(1)(c) (entry to places where clinical trials of imported goods are being conducted), s 46 of the Act (entry to monitor compliance with the Act) or s 48 (general powers of search, examination, sampling, and testing ancillary to entry pursuant to ss 46(1)(b) and 47(1)(b)). Thus, on the respondent’s submission, reg 25(3)(a) applies to the taking of samples “by any means”.

70    We do not accept that submission. As the appellant correctly submits, it ignores the reference in reg 25(3)(a) to an “authorised officer”, which is defined at reg 2 as meaning: “in relation to a provision of these Regulations, … an officer authorised by the Secretary to exercise powers under that provision.” Plainly when an analyst asks an authorised officer to take samples under reg 25(3)(a) the power then exercised is pursuant to the Regulations.

71    The respondent’s argument is not assisted by resort to a purposive construction, by which it is said that limiting the operation of Pt 5 frustrates its purpose. That submission cannot be reconciled with the consequence that flows from confining the definition of an authorised officer to one who exercises powers under the Regulations. It follows that we agree with the primary judge’s conclusion that Pt 5 applies in limited circumstances.

72    And, crucially, both the Act and the Regulations themselves contemplate testing and sampling which are clearly outside of and separate to the limited circumstances addressed in Pt 5. For example, as outlined above, s 48(1)(b) of the Act provides that an “authorised person” may, under s 46(1)(b) or s 47(1)(b), “conduct tests on or take samples of any therapeutic goods on the premises”. This power to conduct tests and take samples is not covered or contemplated by the procedures and relevant circumstances in Pt 5 of the Regulations.

73    The respondent nevertheless submitted that “sample” and “test” in the Specification plainly refers only to the procedure for testing in Pt 5 of the Regulations. The respondent contended that the reference to “laboratory” testing in the title suggests that “sample” and “test” are being used in their “technical” sense and refer to the laboratory testing activities of the TGA carried out in accordance with Pt 5 of the Regulations.

74    The respondent submitted that Pt 5 of the Regulations serves a critical function within the statutory regime, namely:

to permit reliable, valid conclusions to be reached, and proved, about a large set (such as a batch) of goods, based on test results obtained from a small sample. It is concerned to minimise the types of errors that can undermine extrapolation based on taking and then testing a small number of physical samples from a larger set of similar products.

75    If “test” and “sample” under the Specification are construed to include testing and sampling undertaken not in accordance with Pt 5, the respondent contended that this was would “convert” the power to publish “therapeutic goods information” under s 61(5C) into a “standalone regulatory power” to publish, with statutory immunity, the results of “anything falling within the broad, ordinary meaning of the English words ‘sample’ or ‘test’”, which would result in a serious distortion of the statutory scheme and would undermine the careful regime in Pt 5.

76    That submission cannot be accepted because the power under s 61(5C) to publish information relating to testing and sampling is constrained in that the information must be “therapeutic goods information” within the meaning of s 61(1). This means that the information relating to samples or tests must (1) be “in relation to therapeutic goods”; (2) be “held by the Department”; and (3) “relate to the performance of the Department’s functions”.

77    Furthermore, it is clear that the Act has an inherent protective purpose. As Stone J observed in Secretary, Department of Health and Ageing v Prime Nature Prize Pty Ltd (in liq) [2010] FCA 597 at [22], the Act is “an important public health and safety measure” and is “dominated by public interest concerns”. This protective purpose supports a broader construction of the Specification, in that there is a public interest in having a wider, rather than narrower, range of information about testing and sampling being made available on the public record. Conversely, in the context of the Act’s protective purpose, consideration of individual participants’ reputations assumes less significance when interpreting the Act and the Specification.

78    The purpose of the Specification is also relevant. The Explanatory Statement to the Specification, which was considered by the primary judge at [56], provides that its purpose is to “facilitate the publication of certain information to the laboratory testing activities of the TGA in its exercise of powers and functions under the Act” with the intention of increasing “transparency and understanding of the regulation of therapeutic goods, promote consumer confidence in the quality, safety and efficacy of therapeutic goods, and encourage industry compliance with legislative requirements”. As the appellant submitted, this purpose is best achieved by understanding “sample” and “test” as encompassing all activities of the TGA, not just those conducted under Pt 5 of the Regulations.

79    For those reasons, in our respectful view, the primary judged erred in concluding that references to “samples” and “tests” in Sch 1 to the Specification do not encompass sampling and testing conducted outside of the regime for sampling and testing prescribed in Pt 5 of the Regulations.

“Test” and “sample” in the Specification encompass testing and sampling conducted in exercise of a non-statutory executive capacity

80    Although it was not necessary for him to determine the point, the primary judge was of the view that, “absent Pt 5 of the Regulations, the Department would have the power to undertake non-statutory sampling and testing where samples are obtained, and testing is conducted, without any interference with any legal rights of another person”. See J [109].

81    Relatedly, the primary judge also held (at J [108]) that if it were necessary for him to determine the point, the Department’s capacity to undertake non-statutory sampling and testing is not wholly displaced by Pt 5 of the Regulations.

82    With respect, we agree.

83    On appeal, the respondent argued that the testing and sampling to determine compliance with essential principles is a matter “so squarely the provenance of Pt 5 of the Regulations” that Pt 5 must be taken to have excluded the existence of any parallel non-statutory executive capacity to do so, citing Davis v Minister for Immigration, Citizenship, Migrant Services and Multicultural Affairs (2023) 97 ALJR 214; [2023] HCA 10 at [96] (Gordon J). In that respect, the respondent submitted that, if necessary, this Court on appeal should find that the primary judge erred in expressing the view at J [108].

84    We, however, consider that the non-statutory capacity must exist and agree with the primary judge that Pt 5 does not wholly displace or relevantly modify that non-statutory capacity.

85    As the appellant submitted, Chapter 4 of the Act establishes a regulatory regime under which there are many circumstances where it may be necessary for the Department, its officers and the Secretary to test and sample medical devices for the purposes of determining compliance with the essential principles. Accordingly, we consider that there must be a non-statutory executive capacity to conduct tests and samples of medical devices to ensure such compliance.

86    And Pt 5 does not displace or modify that capacity because, as submitted by the appellant, although a non-statutory capacity is susceptible to statutory control (Davis at [22] (Kiefel CJ, Gageler and Gleeson JJ), [65] and [95] (Gordon J)) it does not have that effect. As explained in Ruddock v Vadarlis (2001) 110 FCR 491; [2001] FCA 1329 at [183] by French J (Beaumont J agreeing; Black CJ dissenting):

There is no place then for any doctrine that a law made on a particular subject matter is presumed to displace or regulate the operation of the executive power in respect of that subject matter. The operation of the law upon the power is a matter of construction.

87    At J [184] his Honour reasoned displacement requires clear words or a necessary implication, particularly by reference to Barton v Commonwealth (1974) 131 CLR 477 at 288 (Barwick CJ), 501 (Mason J) and 508 (Jacobs J).

88    There are no express words and in our view no necessary implication from Pt 5’s provisions and context that displaces the non-statutory capacity of the Secretary and officers of the Department. That it provides for various types of examination, testing and analysis of goods is insufficient. There is no implication that its provisions cover the entire field of when goods may be sampled, tested and so forth. As explained, it is concerned only with the powers of authorised officers in relation to the Regulations and no more. It is not a code.

89    Once the existence of the non-statutory capacity is accepted, there is nothing to indicate that the natural and ordinary meaning of “sample” and “test” in the Specification does not encompass samples and tests conducted in the exercise of that capacity; and that “sample” and “test” in the Specification therefore encompasses sampling and testing conducted in the exercise of the Secretary’s non-statutory executive capacity to determine non-compliance with essential principles.

Disposition of appeal and ground 1 of contention

90    It follows that we would allow the appeal and dismiss ground 1 of the respondent’s notice of contention.

PUBLISHED INFORMATION WAS “THERAPEUTIC GOODS INFORMATION”

91    As an alternative contention, the respondent submitted that publication of the information was nevertheless not authorised because it was not “therapeutic goods information” within the meaning of s 61(1) of the Act, and therefore not capable of publication under s 61(5C).

92    The respondent submitted that this was because “the assertion made on the TGA website concerned a conclusion of ‘non-compliance’ of each batch, rather than the information about the results of testing specific samples, which was the information that the Secretary held for the purposes referred to in s 61(1)”.

93    This submission cannot be accepted and may be dealt with briefly. The power at s 61(5C) is to publicly release therapeutic goods information. The release in this case was information of that type because it satisfied the definition at s 61(1). Where that requirement is met, the exercise of the power is not otherwise constrained.

Disposition of ground 2 of contention

94    It follows that we would dismiss ground 2 of the notice of contention.

DECISION WAS NOT LEGALLY UNREASONABLE

95    The alternative argument raised in ground 3 of the respondent’s notice of contention was that the decision of the primary judge to quash the publication decision should still be affirmed on the basis that it was legally unreasonable for the delegate of the Secretary to decide to publish information asserting the non-compliance of entire batches, as opposed to non-compliance by the specific masks sampled, without the benefit of the extrapolation measures provided for in Pt 5 of the Regulations.

96    This contention may also be shortly addressed. The Secretary made a decision to publish therapeutic goods information. There is confusion in the respondent’s arguments which contend legal unreasonableness in the manner of publication: that is “information asserting non-compliance by entire batches, as opposed to non-compliance by the specific masks sampled.” This is an argument about the manner of expression by the Secretary. The respondent led no evidence before the primary judge to establish the basis for the submission now made that because none of the extrapolation measures in Pt 5 of the Regulations were applied, it follows that there is no evident or intelligible justification for the decision to publish.

Disposition of ground 3 of contention

97    It follows that we would dismiss ground 3 of the respondent’s notice of contention.

CONCLUSION

98    For these reasons, we would allow the appeal and set aside the orders of the primary judge. There is no reason why costs should not follow the event of the appeal and the proceedings. We order as follows:

1.    The appeal is allowed.

2.    The orders made by the primary judge on 24 July 2023 are set aside.

3.    The originating application filed on 2 September 2022 is dismissed.

4.    The respondent is to pay the costs of the proceeding and of the appeal.

Associate:

Dated:    5 June 2024

REASONS FOR JUDGMENT

SNADEN J:

99    I have been fortunate to have reviewed in draft the reasons of O’Callaghan and McElwaine JJ. I am grateful to their Honours for reciting as fulsomely as they have the matters of background and principle that are relevant to the appeal. Regrettably, I am unable to agree that the appeal should succeed on the bases that they identify (or at all). For reasons that can shortly be stated—and in which I shall endeavour to incorporate the same defined terms to which the majority has referred—I would dismiss the appeal with costs.

100    Respectfully, the learned primary judge was correct to construe the Specification as he did. Precisely for the reasons that his Honour identified—and that, for present purposes, I would embrace as my own—the terms “samples” and “test”, as they appear in the Specification, should be read consistently with the concepts of “sampling” and “testing” that are the subject of provision under the Act and the Regulations.

101    It is to be recalled, as the learned primary judge noted, that the Regulations (or the parts of them of present relevance) are authorised pursuant to s 63(2)(d) of the Act. That subsection contemplates regulations that provide for the procedures to be followed in sampling and testing therapeutic goods. On any view, those procedures are—and were intended to be—integral to the regulation of public access to therapeutic goods in Australia. They very plainly exist as a source of rigour to ensure public confidence in the safety and utility of such goods; and to ensure that those who supply them can know how their wares—and those of their competitors—will be assessed against the important standards established under the Act. Insofar as the Act contemplates other means of sampling and testing, they too must similarly be understood.

102    To construe the Specification as the appellant construes it would be to compromise the integrity of that regime; and, that being so, the court should be slow to interpret the Specification in a way that would effect such a compromise. The Department seeks here to avail itself of a power available to it under a statutory scheme—and to benefit from the immunity that, by s 61A(1), the Act attaches to its exercise—without having abided by the processes that unambiguously comprise a crucial component of that same statutory scheme (and of which it could and should have availed itself in the circumstances relevant to this matter).

103    On the one hand, the Act and its subordinate instruments contemplate the application of rigorous and incorruptible processes to regulate the sampling and testing of therapeutic goods; and, on the other, the public release of information related to the sampling and testing of therapeutic goods. Just as the learned primary judge did, I regard that conceptual identity as significant. If it were intended that the latter might extend to the publication of information obtained otherwise than through the deployment of the former, one would expect to have seen that intention reflected somewhere in words of clear application.

104    Indeed, the Specification now does contain such words. After the primary judgment was handed down, it was amended so as to make clear, prospectively, that references to “sample[s]” should be understood to include references to samples taken “in the exercise of the executive power of the Commonwealth”.

105    In the absence of words that clearly reflect a legislative or executive intention of that kind, I would not attribute to the Specification a construction that sits discordantly with—and that would not insignificantly distort—what otherwise presents on its face as an harmonious statutory and quasi-statutory scheme.

106    The references in the Specification to “samples” and “tests” (and variants thereof) are properly to be understood as references to samples obtained and tests undertaken in accordance with processes that are authorised under the Act. That was the conclusion of the learned primary judge (J [124]) and, respectfully, his Honour did not err in drawing it.

107    With that conclusion stated, there is little to be gained by addressing in any detail the respondent’s notice of contention. Save to the extent addressed above, I respectfully agree with what the majority has said about it.

108    The appeal should be dismissed, and the appellant should pay the respondent’s costs of and pertaining to it.

Associate:

Dated:    5 June 2024