FEDERAL COURT OF AUSTRALIA

Abbey Laboratories Pty Ltd v Australian Pesticides and Veterinary Medicines Authority [2016] FCA 704

ORDERS

THE COURT ORDERS THAT:

1.    The decisions of the respondent made respectively on 27 August 2015 and 2 September 2015 to re-categorise, under reg 70B(1)(a) of the Agricultural and Veterinary Products Code Regulation 1995 (Cth), the applicant’s applications (the applications) for registration of the chemical products:

(a)    Apramax Apramycin Soluble Powder, lodged on 1 April 2015; and

(b)    Tetramax 980 Soluble Antibiotic Powder, lodged on 8 July 2015;

be quashed.

2.    The respondent determine each of the applications according to law.

3.    Unless the respondent files and serves on or before 17 June 2016 written submissions limited to three pages and any affidavit on which it proposes to rely in support of a different order in relation to costs, the respondent pay the applicant’s costs of the proceedings.

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

REASONS FOR JUDGMENT

RARES J:

1    Abbey Laboratories Pty Ltd operates a veterinary pharmaceutical business in the course of which Abbey develops and markets generic veterinary pharmaceutical products in Australia. The Australian Pesticides and Veterinary Medicines Authority, known as the APVMA, must register any such product that contains an active constituent, before it can be sold in Australia, on the Register of Agricultural and Veterinary Products maintained under s 18 of the Agricultural and Veterinary Chemicals Code that has effect as the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth). The Code applies as a law of the Commonwealth for the government of certain participating Territories and of participating States pursuant to the Agricultural and Veterinary Chemicals Act 1994 (the Agvet Act).

Introduction

2    On 1 April 2015, Abbey applied to the Authority under s 8A(a)(i) of the Code for registration of a chemical product, Apramax Apramycin Soluble Powder (the apramax application). Subsequently on 8 July 2015, Abbey applied to the Authority under s 8A(a)(i) of the Code for registration of another chemical product, Tetramax 980 soluble antibiotic powder (the tetramax application). Each application used the prescribed item 6 form headed “Application for registration of a chemical product similar to a registered chemical product requiring only chemistry and manufacture data”. Item 6 was one of a number of items prescribed in the table in Pt 2 of Sch 6 to the Agricultural and Veterinary Chemicals Code Regulations 1995 (Cth) and applied to a proposed registration of a chemical product that “is closely similar to a registered chemical product” within the meaning of cl 1.2 of Pt 1 of Sch 6 to the Regulations.

3    In the event, as I will explain in more detail later in these reasons, the Authority determined under reg 70B(1)(a)(ii) that each of the apramax and tetramax applications was more correctly categorised as an application of a kind mentioned in item 10 of the table in Pt 2 of Sch 6, namely an application for a chemical product containing an approved active constituent “for all situations other than those described in items 3 to 9”. The Authority arrived at those determinations because it considered that it could not make an assessment of either of Abbey’s applications under item 6 without disclosing, directly or indirectly, “confidential commercial information” (as defined in the Code) about the reference products that Abbey had identified as being “closely similar” to apramax and tetramax. The Authority considered that such a disclosure necessarily would occur when it gave Abbey a notice of its decision under ss 8F or 8G of the Code and, in the case of an approval, published such a notice in the Gazette under s 8H(2)(a), or, in the case of a refusal, gave Abbey a draft statement of its reasons under s 8S(2).

4    Section 162 of the Code prohibits an officer of the Authority from making any disclosure of confidential commercial information and creates a criminal offence if an officer does make such a disclosure. However, there are exceptions to this general proscription. Those can be found by intrepid imitators of Theseus who must penetrate the unfortunately typical Commonwealth legislative labyrinth that defies comprehension by mere mortals. Confused by this legislative morass, the Authority reasoned that s 162 of the Code precluded it from using, in an assessment under item 6, confidential commercial information of Bayer Australia Ltd, whose registered chemical products, aprapharm and tetravet, Abbey relied on as “closely similar” respectively to apramax and tetramax.

Issues

5    Abbey claims that the Authority’s determinations, that re-categorised Abbey’s two item 6 applications as being ones under item 10, were erroneous because:

(1)    for the purposes of s 7 of the Administrative Decisions (Judicial Review) Act 1977 (Cth) (the ADJR Act), the Authority failed to make a decision under s 14 of the Code on the item 6 applications or, for the purposes of s 39B(1A)(c) of the Judiciary Act 1903 (Cth), made a jurisdictional error by constructively failing to exercise its jurisdiction to make such decision (the failure to decide issue);

(2)    the Authority misconceived its power under reg 70B(1)(a)(ii) and committed a jurisdictional error by determining that each application was more correctly categorised as one of a kind mentioned in item 10 (the categorisation determination issue);

(3)    the Authority denied Abbey procedural fairness because, before making either determination, it did not give Abbey the opportunity to be heard on whether it ought to re-categorise each application under reg 70B(1)(a)(ii) (the procedural fairness issue).

6    The Authority filed a notice of objection to competency that the Court had no jurisdiction under the ADJR Act because, it contended, each re-categorisation of Abbey’s two applications was not, first, a decision of an administrative character made under an enactment nor, secondly, conduct leading to such a decision (the competency issue).

7    In these reasons, I will describe the relevant features of the legislative scheme, then the detail of the process followed by the Authority and the relevant submissions before explaining my determination of the issues. The parties accepted that there is no substantive difference in the facts or legal issues between Abbey’s two applications and that the matter can be resolved by my making findings on the apramax application that will apply equally to the tetramax application. That is convenient and will avoid a deal of unnecessary detail.

The legislative scheme

8    The object of the Agvet Act was to make a law for the government of certain participating territories, including the Australian Capital Territory, in relation to the evaluation, registration and control of agricultural, as well as veterinary, chemical products, and for related purposes (s 3(1)). That Act provided for each of the States and the other, non-participating Territories, including the Northern Territory, to adopt the Code as a law of their jurisdiction and to confer its executive power on a Commonwealth officer, so that the one officer could exercise both polities’ executive power concurrently or in combination, consistently with the principles in Re Cram; Ex parte NSW Colliery Proprietors’ Association Ltd (1987) 163 CLR 117 at 130-131 per Mason CJ, Wilson, Brennan, Deane, Dawson, Toohey and Gaudron JJ.

9    Their Honours held that in such a co-operative context, persons who exercised powers derived from Commonwealth and State enactments, were (163 CLR at 131; see too ss 18 and 18A(2) and (3) of the Agvet Act):

officers of the Commonwealth and remain so notwithstanding that they exercise or purport to exercise power conferred by the State Act, even if the power being exercised is identifiable as power conferred by the State Act. As such they are subject to the jurisdiction conferred by s 75(v) of the Constitution on this Court in all matters in which a writ of prohibition or mandamus is sought against an officer of the Commonwealth.

10    Here, this Court has jurisdiction by force of s 39B(1A)(c) of the Judiciary Act 1903 (Cth) because this matter arises under one or more laws made by the Parliament, including the Agvet Act and the Agricultural and Veterinary Chemicals Code Act, as well as under the ADJR Act. As a result, the competency issue can only relate to the question whether Abbey is entitled to any relief under the ADJR Act, since the Court has jurisdiction in any event under s 39(1A)(c) of the Judiciary Act.

11    The Agricultural and Veterinary Chemicals Code Act recited the object in s 3(1) of the Agvet Act (recitals (e) and (f)) and by s 4 gave effect to the Code that was contained in the Schedule to that Act. The Governor-General had power to make regulations, under s 6, to prescribe any matters required or permitted to be prescribed by the Code.

12    Section 3 of the Code contained definitions that included the following terms, unless the contrary intention appeared:

application means an application under this Code.

confidential commercial information, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product or a constituent of a chemical product, means:

(a)    a trade secret relating to the constituent or product; or

(b)    any other information relating to the constituent or product that has a commercial value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed; or

(c)     information (other than trade secrets to which paragraph (a) applies or information to which paragraph (b) applies) that:

(i)    concerns the lawful commercial or financial affairs of a person, organisation or undertaking; and

(ii)    relates to the manufacture, distribution or supply of the constituent or product; and

(iii)    if it were disclosed, could unreasonably affect the person, organisation or undertaking in an adverse manner;

…

determine, in relation to an application, means:

(a)    approve, register, renew, vary or issue upon the application; or

(b)    refuse the application. (emphasis added)

13    Section 6C provides:

6C    Right of APVMA to use information

(1)    The APVMA may use information obtained by it from any source for the purpose of performing any of its functions or exercising any of its powers under this Code.

(2)    Subsection (1) has effect subject to this Code.

14    Division 2 of Pt 1 of the Code sets out general provisions about applications. Relevantly, s 8A relevantly provides:

8A    Definition of meets the application requirements

An application meets the application requirements if:

(a)    the application:

(i)    is in writing in the approved form; and

(ii)    is signed by the applicant; and

(iii)    is accompanied by so much of the prescribed fee as is required to be paid when the application is made; and

(iv)    is lodged with the APVMA; and

(v)    contains, or is accompanied by, any information specified for the application by the APVMA under section 8B or prescribed for the application by the regulations for the purposes of this subparagraph.

(b)    the constituent, product or label in relation to which the application is made complies, or will comply, with any requirement prescribed by the regulations;

… (emphasis added)

15    The Authority had power under s 8B(1) to specify, by legislative instrument, information that had to be contained in, or accompany, an application. The Authority made the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 (Cth) that required the provision of general information (cl 9), including whether the applicant considered that the Authority could use information, and the nature of that information, in determining the application (cl 9(1)(e)), technical information (cl 12), safety, efficacy and trade criteria (cll 17, 18 and 19).

16    Importantly, s 8F(1)(b) provides that the Authority must give written notice to the holder (of a registration as defined in s 3) within 14 days, if it registers a chemical product. The requirements for the contents of such a notice are set out in s 8F(2) and include, in the case of a registration, a statement that the product has been registered and any relevant conditions or particulars together with any information prescribed by the Regulations (s 8F(2)(a), (e): see reg 8AK(b)). The note at the foot of s 8F(2) refers to s 8X and states that it does not authorise the disclosure of confidential commercial information, the disclosure of which would otherwise be prohibited by s 162. Conversely, s 8G provided:

8G    Notice to applicant of refusal of application

(1)    The APVMA must give written notice to the applicant within 14 days if the APVMA refuses an application.

Note:    For notices in relation to reconsiderations, see Division 4 of Part 2.

(2)    The notice must:

(a)    state that the application has been refused; and

(b)    set out the reasons for the refusal; and

(c)    include any information prescribed by the regulations; and

(d)    specify any amount of fee that is repayable because of the refusal.

Note:    Other provisions of this Code specify additional requirements for certain notices of refusal.

(emphasis added)

17    The Authority, ordinarily, must publish notice of the registration of product and any conditions that regulate its use in the Gazette (s 8H). Where the Authority proposes to refuse an application it must give the applicant a notice in writing under s 8S(1) in which case, ss 8S(2) and (3) relevantly provide:

(2)    The notice must:

…

(c)    include a draft statement of reasons for the proposed course of action; and

(d)    set out the information on which the reasons are based (including information not given to the APVMA by the applicant); and

(e)    invite written submissions from the applicant within 28 days, or within such further period as is specified in the notice.

Note:    This subsection does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: see section 8X.

(3)    The APVMA is not required to take account of anything given in response to the invitation under paragraph (2)(e) that is not related to information:

(a)    already given to the APVMA by, or on behalf of, the applicant; or

(b)    set out in the notice under paragraph (2)(d).

18    Also, relevantly, s 8X provides:

8X    Confidential commercial information must not be disclosed under certain provisions

(1)    Engaging in conduct in the performance of functions or duties, or the exercise of powers, under any of the following provisions does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162:

(a)    subsection 8F(2);

(b)    subsection 8S(2);

…

(2)    Subsection (1) has effect despite subsection 162(1A).

(emphasis added)

19    Part 2 of the Code deals with approvals and registrations. It contains a degree of unnecessary repetition. Thus, s 10 provides that a person may apply to the Authority for registration of a chemical product and the application “must meet the application requirements” (s 10(2)(a)) being what s 8A had already set out, including in s 8A(a)(iv) the requirement that the application be lodged with the Authority. The fact that the Code repeats the obvious in places (ss 8A, 9A(2) and 10), namely that a person had to apply to the Authority for registration, is a simple illustration of its overwhelming prescriptive nature and capacity to obscure rather than declare the legal rules governing a subject matter.

20    The Authority has to complete a preliminary assessment of an application within one month after it is lodged (s 11(1)). If it appears from the preliminary assessment that the application meets the application requirements, the Authority has to give written notice of that fact to the applicant, within 14 days, that also sets out any matters prescribed by the regulations (s 11(2)). Relevantly, reg 8 AO(2)(e) prescribes that the notice has to include a statement that “the APVMA may determine … that the application is more correctly categorised as an application mentioned in a different item in Part 2 of Schedule 6 to the item in relation to which any fee has been paid” and specifying any additional fee payable in that event, being a reference to the Authority’s power to recategorise in reg 70B to which I will come to later in these reasons. If the Authority is not satisfied that the application requirements have been met, s 11(3) requires it to refuse the application. Moreover, s 11(4) provides that the Authority can “alter the application, after it has passed preliminary assessment, with the written consent of the applicant”.

21    The key provision for present purposes is s 14 that relevantly provides:

14    Approval and registration

(1)    The APVMA must … register the chemical product, if it is satisfied:

(a)    that the application meets the application requirements; and

…

(c)    for a chemical product—that the product:

(i)    meets the safety criteria, the trade criteria and the efficacy criteria; or

(ii)    complies with the established standard for the product; and

…

Note:    For notice of approval or registration, see section 8F.

(2)    Otherwise, the APVMA must refuse the application.

Note: For notice of refusal, see section 8G.

(emphasis added)

22    The Authority has to keep the Register in two parts, one of which has to contain confidential commercial information and, subject to s 162, the second part of the Register will be open for public inspection (s 18).

23    Division 4A of Pt 2, and in particular s 34G, imposes limits on the Authority using information given to it in connection with an application under s 10 that, relevantly, was made after the commencement of the US Free Trade Agreement Implementation Act 2004 (Cth) on 1 January 2005 (s 34G(2)(a)). Since tetravet was first registered on 19 February 2001 and aprapharm on 19 February 2004, Div 4A of Pt 2 has no apparent application to the facts in issue.

24    Importantly, s 162 relevantly provided:

162    Disclosure of confidential commercial information

(1)    A person who is or has been a director, the Chief Executive Officer, or a member of the staff, of the APVMA, or is or has been a consultant to the APVMA, a mediator or arbitrator appointed under this Code, or a co ordinator designated for a jurisdiction, must not disclose, directly or indirectly, to another person any information about an active constituent for a proposed or existing chemical product, about a chemical product or any of its constituents, or about a label for containers for a chemical product, that:

(a)    the person knows to be confidential commercial information; and

(b)    was acquired by the person in the performance of such functions or duties or the exercise of such powers.

Penalty:    Imprisonment for 2 years.

(1A)    Subsection (1) does not apply to the extent that the person engages in the conduct in the performance of functions or duties, or the exercise of powers, under this Code.

Note:    The defendant bears an evidential burden in relation to the matter in subsection (1A). See subsection 13.3(3) of the Criminal Code.

(2)    Subsection (1) does not prohibit the disclosure of information about a constituent or a chemical product to a court in any proceeding but the court must do all things necessary to prevent disclosure of that information to any other person except for the purpose of the proceeding.

…

(11)    A notice published under section 8H or 8J, paragraph 45A(1)(b) or section 47C must not contain any confidential commercial information about an active constituent for a proposed or existing chemical product or about a chemical product or any of its constituents.

(14)    In this section:

disclose, in relation to information, means give or communicate in any way. (emphasis added)

25    The Code also provides for the making of regulations prescribing the fees, or a method of working out the fees to be paid in respect of the making of an application to the Authority and when those fees are to be due and payable (s 164(1), (2)). As will appear below, reg 70 and Sch 6 to the Regulations deal with fees. The Authority has power, by dint of s 164(8) to waive or remit the whole or any part of a fee that has been paid in certain circumstances including if the application were withdrawn. The Authority had to determine applications made under the Code within the period provided for in the Regulations (s 165(1)).

26    A person can apply to the Administrative Appeals Tribunal under s 167 to review decisions of the Authority including, decisions under s 14, to register or refuse to register a product or, under s 164(8), to refuse to waive or remit a fee.

27    Division 9.2 in Pt 9 of the Regulations provides for the fees payable in respect of applications under the Code or the Regulations (see reg 70(1)). Regulation 70(2) prescribed the fee “payable for an application of a kind mentioned in column 1 of an item in Part 2 of Schedule 6”. The minimum amount payable for the lodging of Abbey’s application was $710, unless a lesser sum applied (reg 70(6)(b)) and the balance would become payable within 28 days after the date of giving a notice to an applicant under, relevantly, reg 8AO (being a notice of preliminary assessment). As noted above, reg 70B gave the Authority power to re-categorise an application, relevantly, as follows:

70B    Recategorised applications

(1)    This regulation applies if:

(a)    both of the following apply:

(i)    the fee mentioned in subregulation 70(2) (the application fee) has been paid in relation to an application on the basis that the application is of a kind mentioned in an item of the table in Part 2 of Schedule 6 (the original item);

(ii)    the APVMA determines, at any time after preliminary assessment of the application, that the application is more correctly categorised as an application of a kind mentioned in a different item of the table (the recategorised item); (emphasis added)

28    Where the original application fee is less than that applicable to “the recategorised item”, reg 70B(3) requires the Authority to notify the applicant in writing that it has made the re-categorisation, and of any different assessment period that now applies. The applicant had to pay the difference between the two fees before the Authority could determine the application and, if that payment were not made within 28 days, it could be dismissed.

29    Schedule 6 to the Regulations is headed “Application fees and assessment periods”, and is in two parts. Part 1 contains definitions for the purposes of the Schedule, including (cl 1.1) that when used in respect of two chemical products “closely similar” has the meaning in cl 1.2 and “similar” has the meaning in cl 1.3. Relevantly, cl 1.2(3) provided:

a veterinary chemical product (the proposed chemical product) and a reference chemical product are closely similar if:

(a)    the active constituents in the proposed chemical product are the same as the approved active constituents in the reference chemical product; and

(b)    the concentration of the active constituents referred to in paragraph (a) are the same; and

(c)    either:

(i)    the non-active constituents in the formulations of the proposed and reference chemical products are the same, or are equivalent substances, at the same or equivalent concentrations; or

(ii)    if the non-active constituents in the formulations of the proposed and reference chemical products are neither the same nor equivalent, the differences in the formulations are minor and are not expected to have adverse implications on product quality or biological activity in terms of efficacy, safety or residues; and

(d)    either:

(i)    the proposed and reference chemical products specifications (including release and expiry limits and test methods) and physico-chemical properties (including pH, particle size, crystal form and, where applicable, dissolution profile, payout rate and payout period) are the same or equivalent; or

(ii)    if the specifications and physico-chemical properties of the proposed and reference chemical products are neither the same nor equivalent, the differences in the specifications and properties are minor and are not expected to have adverse implications for product quality or biological activity in terms of efficacy, safety or residues; and

Note for paragraphs (c) and (d):    Efficacy, safety and residues data are not required to demonstrate similarity of the proposed chemical product to the reference chemical product.

(e)    the dose form and formulation type of the proposed and reference chemical products are the same; and

(f)    the use patterns (including target animal species, dose rates, routes of administration and withholding periods) and instructions on the labels of the proposed and reference chemical products are the same; and

(g)    either:

(i)    the claims on the labels of the proposed and reference chemical products are the same; or

(ii)    if the claims are different, the claims on the label of the proposed chemical product are fewer or reduced compared to the claims on the approved label of the reference chemical product.

30    Next, cl 1.3(3) provided:

a veterinary chemical product (the proposed veterinary chemical product) and a reference chemical product are similar if:

(a)    the conditions in paragraphs 1.2(3)(a), (b), (e), (f) and (g) are complied with in relation to the products; and

(b)    the non active constituents in the proposed and reference chemical products have similar properties and are in similar proportions; and

(c)    chemistry and manufacture, efficacy or target species safety data is required to demonstrate similarity of the proposed chemical product to the reference chemical product.

31    Finally, Pt 2 of Sch 6 relevantly provided a “Table of fees and assessment periods” under the heading in column 1 “Description of application”:

6    Application for registration of a chemical product containing an approved active constituent, and approval of the product label, if:

(a)    the chemical product is closely similar to a registered chemical product; and

(b)    efficacy and safety data are not required to demonstrate the similarity of the chemical product to the registered chemical product; and

(c)    chemistry and manufacture data are required

…

10    Application for registration of a chemical product containing an approved active constituent … and approval of the product label for all situations other than those described in items 3 to 9. (emphasis added)

32    The assessment period in column 2 of the table for item 6 was eight months and for item 10 was “the modular assessment period”, being a reference to the relevant periods in Sch 7.

The apramax application background

33    On 19 February 2004, the Authority registered Bayer’s aprapharm product. The Register listed its active constituent as apramycin sulfate, as did the approved product label of “Aprapharm Soluble Powder”. The Register had also recorded details of the active constituent of tetravet since its registration.

34    In answer to box 10 of the Authority’s item 6 application form, Abbey stated that the “formulation type” was powder. In answer to box 17, Abbey identified the issues associated with each application as follows:

… we are only seeking the [Authority] to rely on information and data we have provided with this submission including the public information associated with the reference product so that our application can be assessed on its own merits without accessing confidential commercial information related to the reference product, taking into consideration that the similarity that we refer to, between our proposed product and the reference product is based on publicly available information only. Our proposed product is [sic] 100% active constituent … is closely similar to the reference product and do NOT require technical assessment of any data other than chemistry and manufacture data … (emphasis added)

35    Abbey provided, what it said, was full chemistry and manufacturing data with its applications. In box 21 of the item 6 form Abbey said that the active constituent in both its and the reference products “is registered and marketed in Australia and all over the world”. Abbey stated in box 10 of the apramax application, that apramycin sulfate was the active constituent for apramax.

36    Abbey asserted in item 33 of each form that its proposed product:

is closely similar to the reference product and do [sic] NOT require technical assessment of any data other than the chemistry and manufacture because the formulation, dose form and use pattern (including target animal species, dose rates, route of administration, withholding periods), label claims and label instructions are all the same and the products would be expected to be equivalent in terms of any special requirements.

37    On 16 April 2015, the Authority gave notice to Abbey under s 11(2) of the Code that the apramax application had passed preliminary assessment. The notice stated that the Authority could determine to re-categorise the application and that, if it did so, a further amount of assessment fee might be payable and the assessment period of eight months (to 13 January 2016) might also change (cf: reg 8AO(2)(e)). A tax invoice for $3,580 accompanied the notice. Abbey paid the amount of that invoice.

38    On 27 August 2015, the Authority gave notice to Abbey under reg 70B(3) that it had re-categorised the apramax application from being one under item 6 to one under item 10 of Pt 2 of Sch 6 and that a further fee of $585 was payable. The notice also stated that the assessment period had changed and was now eight months (which I infer was calculated from the date of the notice and would now extend to late April 2016). Abbey paid that further fee under protest.

39    On 18 September 2015, Abbey asked the Authority to furnish a statement under s 13(1) of the ADJR Act in respect of its decision to re-categorise the apramax application. That section required a decision-maker to prepare a statement of reasons setting out its findings on material questions of fact, referring to the evidence or other material on which those findings were based and giving reasons for the re-categorisation decision for the apramax application.

The Authority’s reasons

40    On 19 October 2015, the Authority provided Abbey with its decision-maker’s statement of reasons for the apramax decision of 27 August 2015 (the apramax reasons). The statement of reasons of a different decision-maker for her decision of 2 September 2015 for re-categorising the tetramax application was also given on 19 October 2015 and was in materially similar terms. Each statement of reasons commenced:

DECISION

Pursuant to regulation 70B(1)(a) of the Agricultural and Veterinary Chemicals Code Regulations 1995 (Cth) (the Regulations), I have determined to re-categorise your application as an item 10 of the table in Part 2 of Schedule 6 of the Regulations

application.

REASONS FOR DECISION

1.    The reasons for my decision are as follows. (emphasis added)

41    The apramax reasons (at [17]) set out the whole of what Abbey had asserted in answer to box 17 (that I partly quoted at [34] above) and retorted:

18.    Contrary to Abbey’s submission, I am not satisfied that each of the requisite comparisons under s 1.2 could be made only on the basis of publicly available information. Abbey has not pointed to or provided information to the APVMA that would be sufficient to enable the APVMA to determine whether Apramax is or is not closely similar to Aprapharm. (emphasis added)

42    The Authority found in its statements of reasons that it could assess each application in respect of the criteria in cll 1.2(3)(a), (b), (e), (f) and (g) against information in the public domain, including information in its public database of registered chemical products that included each reference product. And, it also found that because each of apramax and tetramax had no excipients added to its active ingredient, the criterion in cl 1.2(3)(c) was not relevant. However, it found that in order to assess whether Abbey’s proposed chemical products could meet the criterion in cl 1.2(3)(d) it would have to access confidential commercial information in each reference product’s file.

43    Each decision-maker then referred to s 162(1) and reasoned as follows (the relevant reasoning being in substantially identical terms):

    the decision-maker would need to have regard to information about the reference product that had commercial value that would be, or could reasonably be expected to be destroyed or diminished “if the information were disclosed” (emphasis added);

    if the Authority decided to register apramax it would have to give Abbey a notice under s 8F and:

30.    … In an application brought under Item 6 of Part 2 of Schedule 6, it is implicit in such a decision that the chemical product is closely similar to the reference product including by reference to its specifications, composition and the manufacturing process of the active constituent. In this case, the decision would necessarily be based on comparison between the information held by the APVMA in relation to Apramax and Aprapharm, including the CCI [confidential commercial information] held in respect of Aprapharm. Accordingly, a notice under s 8F of the Code would ‘directly or indirectly’ disclose CCI about a chemical product contrary to s 162(1).

31.    Similarly, in the event the APVMA proposes to refuse the Application, it must give notice to Abbey under s 8S(1). The notice must include in accordance with s 8S(2) a draft statement of reasons and the information on which the reasons are based.

32.    Subsection 162(1A) of the Code authorises the disclosure of CCI ‘the extent that the person engages in the conduct in the performance of functions or duties, or the exercise of powers, under this Code’. However, this is not applicable to a notice under s 8F or s 8S of the Code: see the note to ss 8F(2) and 8S(2) and ss 8X(1)(a), (b) and (2). (emphasis added)

The Authority’s submissions

44    The Authority argued that communication of its decision to Abbey necessarily would disclose directly or indirectly confidential commercial information about the reference product. The information, so the argument ran, was that Abbey’s product either had met or failed to meet the criterion in cl 1.2(3)(d) of Sch 6 to the Regulations: i.e. that Abbey’s chemical product’s specifications and physico-chemical properties, first, were the same as, or equivalent to, Bayer’s reference product’s or, secondly, were neither the same nor equivalent but the differences in the specifications and properties were minor and that the Authority had assessed that the differences are not expected to have adverse implications for product quality or biological activity in terms of efficacy, safety or residues.

45    Critically, the Authority argued that:

..approval or refusal of registration will, of themselves, disclose whether or not the proposed and reference products are closely similar as defined. That, in turn, discloses information about the reference product. That may or may not be CCI [confidential commercial information]; and

the legislation specifically prohibits disclosure of CCI in notices required by the Code to be given. This constitutes an offence under s 162 of the Code. (emphasis added)

46    It contended that the legislative scheme put an applicant for approval or registration on notice that the Authority might re-categorise an application during the course of its assessment or evaluation and thus, there was no occasion to offer an applicant a further opportunity to be heard on that possibility before the Authority acted. It also submitted that the Code required that an applicant be given an opportunity to be heard when the Authority was proposing to refuse an application, before it made a final decision.

47    In support of its objection to competency, the Authority argued that Abbey was aware, when making each application that the assessment and evaluation of the relevant application might require it to have regard to confidential commercial information. The Authority argued that re-categorisation of an application made under one item in Pt 2 of Sch 6 of the Regulations, to another item, was no more than a procedural step in the course of assessing an application under s 10 of the Code and that no decision under an enactment occurred until the Authority made a decision under s 14 of the Code. The Authority contended that the decision to re-categorise under reg 70B was not a decision under an enactment in the sense explained by Mason CJ in Australian Broadcasting Tribunal v Bond (1990) 170 CLR 321 at 338 and 341. It submitted that the re-categorisation was a mere step along the way to a decision under s 14 of the Code and was only procedural rather than being substantive in its effect, so that it was not a “decision” for the purposes of the ADJR Act.

48    The Authority also relied on evidence that on 23 December 2015, after deciding to re-categorise the two applications and after the commencement of these proceedings, it had invited Abbey to make further submissions on that matter but that invitation was declined.

Consideration – the failure to decide issue

49    The critical question is whether, if the Authority decided to register either of Abbey’s chemical products, apramax or tetramax, under s 8F(1)(b) of the Code or refuse either application under s 8G(1), it would disclose confidential commercial information of Bayer in breach of s 162(1) by giving Abbey notice of its decision or any reasons for a proposed or actual refusal or by publishing notice of a decision to register in the Gazette pursuant to any of ss 8F(2), 8G(2) and 8H of the Code or reg 8AN.

50    Nothing in the Code or Regulations required any publication in the Gazette to disclose the basis on which an approval had been sought or granted. Accordingly, a publication, simply of the fact that an application for registration had been granted, could not disclose anything confidential or otherwise about a reference product.

51    Importantly, s 162(1A) provides that an officer of the Authority can engage in conduct in the performance of functions or duties, or the exercise of powers, under the Code, that s 162(1) would otherwise have prohibited, because he or she would disclose (i.e. give or communicate in any way (s 162(14)) by such conduct, any information about an active constituent for a proposed or existing chemical product that the person, first, knows to be confidential commercial information and, secondly, was acquired by him or her in the performance of those functions or duties or the exercise of those powers.

52    Here, the Authority registered tetravet in 2001 and approved aprapharm in 2004. Each of their current registrations will need to be renewed from 30 June 2016. It is safe to infer that each reference product had been on the market since about the time of its registration or approval. It appears that tetravet is no longer being sold.

53    Obviously, each reference product could be tested and analysed for its properties and characteristics by anyone who purchased it. Because each product was publicly available, anything that could be ascertained by a person, including a skilled scientist, from examining the product, could not possibly be confidential to the manufacturer.

54    If the Authority proposes to refuse an application, it must first give the applicant a written notice of what it proposes to do pursuant to s 8S(1)(a). That notice must include a draft statement of reasons for that proposed course of action (s 8S(2)(c)) and, by force of s 8S(2)(d), “set out the information on which the reasons are based” including information that the applicant had not provided to the Authority. In addition, the notice has to invite the applicant to make written submissions within 28 days or any longer period specified in the notice (s 8S(2)(e)), but the Authority is not required to take any such submission into account if it is not related to information that the applicant had already provided to it or that the Authority set out in the notice pursuant to s 8S(2)(d) (s 8S(3)). However, s 8X expressly proscribes the Authority and its officers from engaging, in the performance of functions or duties or the exercise of powers under ss 8S(2) and 162(1A), where to do so would disclose confidential commercial information the disclosure of which s 162 otherwise prohibits. In other words, s 8X has the effect of prohibiting any disclosure of confidential commercial information in a notice given under s 8S(2)(c) and (d).

55    If the Authority approved either application, it would not give Abbey any more information than s 8F requires, namely that it had registered the chemical product. Abbey would know from that simple fact that the Authority had determined that its product satisfied cl 1.2(3)(d). However, Abbey would have no information about what the Authority had found in respect of any of the variety of alternate bases within cl 1.2(3)(d) in arriving at its ultimate conclusion. For example, the Authority might have decided that Abbey’s product’s specifications and physico-chemical properties were neither the same nor equivalent to those of the reference product but still satisfied cl 1.2(3)(d)(ii). That is, the two products had minor but real differences but that those were not substantive. It follows that no confidential commercial, or other confidential information, about a reference product could possibly be communicated by a decision that found that apramax (or tetramax) was closely similar to Bayer’s reference product in an assessment under item 6 and cl 1.2(3)(d).

56    Similarly, if the Authority refused either application, it would have to give a notice to Abbey in accordance with s 8G. Such a notice must state that the application has been refused and set out the reasons for the refusal as s 8G(2)(a) and (b) require. Unlike the position under s 162(11) (dealing with notices of approvals under ss 8H and 8J) or of suspensions under s 45A(1)(b) (that must be published) or those notices of approval dealt with in s 8X, nothing in the Code proscribed an officer of the Authority from setting out the reasons for refusal as required in s 8G(2)(b). Indeed, s 162(1A) expressly allows an officer to perform that function.

57    No doubt in setting out the reasons for a refusal under s 8G(2)(b), the Authority will be conscious of the need to preserve commercial confidentiality and will, and indeed must, choose the content of its statement of reasons carefully when doing so. Ordinarily, it would probably suffice to say, as a court would say in similar circumstances, that the proposed product was not closely similar to the reference product: see e.g. David Syme & Co Ltd v General Motors-Holden’s Ltd [1984] 2 NSWLR 294 at 300G-301B per Street CJ, 308A-B per Hutley AP, 310G-311A per Samuels JA and Siam Polyethylene Co Ltd v Minister of State for Home Affairs (No 3) [2009] FCA 839 at [8]-[12] where I also discussed this. It may also be possible for the Authority to state one or more of the decisive or distinctive differences, such as that the active constituent did not have a particular feature, such as chemical composition, particle size, pH or crystal form that was closely similar to that of the reference product while also saying, that because of that or those, it was not necessary to consider the degree of similarity of other matters within cl 1.2(3)(d). A statement of fact in such a form would and need not reveal any detail or other information about the reference product (if that were confidential commercial information). That is because that form of revelation is sufficient to explain that, whatever the feature of the two products being compared is, the products are not closely similar by reason of the identified difference (e.g. the pH of each is, or is materially, different). It would not be necessary, particularly if the information were confidential commercial information, for the Authority to state the actual levels of pH or to describe the differences in crystal forms.

58    The definition of confidential commercial information in s 3 of the Code substantively reflects the way in which the general law classifies, as confidential, information in the nature of trade secrets and other commercially sensitive material. Ordinarily, administrative decision-makers can, and must, perform their statutory functions and at the same time afford procedural fairness conscious that they cannot reveal to third parties any matter the disclosure of which is protected or prohibited by the legal principles governing public interest immunity or confidential information.

59    The law in this respect was explained in Applicant VEAL of 2002 v Minister for Immigration and Multicultural and Indigenous Affairs (2005) 225 CLR 88 at 97-100 [20]-[29]. There Gleeson CJ, Gummow, Kirby, Hayne and Heydon JJ held that, where a decision-maker has information that is adverse to the interests of a person who will be affected by an administrative decision, the decision-maker must draw the person’s attention to it, but need not do so in a way that destroys or impairs any confidentiality in respect of the information. Their Honours held that where an Act regulated a decision-maker’s task, the content of the obligation to accord procedural fairness had to be identified, having regard to the scope and objects of the Act as a whole.

60    They said that a decision-maker had to accommodate the public interest in protecting confidential material (in that case, the identity of an informer) with the obligation to afford procedural fairness to a visa applicant by disclosing what the substance of the adverse information was and asking for a response (225 CLR at 100 [29]). They said that “[t]he application of principles of procedural fairness in a particular case must always be moulded to the particular circumstances of that case” (225 CLR at 99 [25]), citing Re Minister for Immigration and Multicultural and Indigenous Affairs; Ex parte Lam (2003) 214 CLR 1 at 13-14 [37] per Gleeson CJ, 16 [48] per McHugh and Gummow JJ (see too Assistant Commissioner Condon v Pompano Pty Ltd (2013) 252 CLR 38 at 98 [152] per Hayne, Crennan, Kiefel and Bell JJ; Eastman v Director of Public Prosecutions (No 2) (2014) 9 ACTLR 178 at 231-232 [165]-169] per Rares and Wigney JJ and Cowdroy AJ; Minister for Immigration and Citizenship v Maman (2012) 286 ALR 680 at 691-692 [37]-[38] per Flick and Foster JJ and the cases there cited, 703-704 [91]-[92] per Katzmann J). Indeed as Gleeson CJ said in Lam 214 CLR at 14 [37]:

Fairness is not an abstract concept. It is essentially practical. Whether one talks in terms of procedural fairness or natural justice, the concern of the law is to avoid practical injustice. (emphasis added)

61    Here, the Code required the Authority not to disclose confidential commercial information in the course of conveying to an applicant adverse information under s 8S(2)(d). The Authority had to mould its procedures so as to comply with its obligations to set out information in a notice under s 8S(2)(d) in a way that did not disclose directly or indirectly matter that s 162(1) prohibited being disclosed. However, the Authority never engaged in its function to assess the two applications. Instead, it decided to re-categorise them before it ever reached the point where it concluded that it could not discharge any obligation under s 8S(2)(d) that might arise, were it to propose refusing either application.

62    Indeed, as I have explained, had the Authority decided to approve the applications, the shadow at which it boxed prospectively would never have appeared. Nor would the Authority or decision-maker know what, if any, confidential commercial information could possibly be relevant under s 8S(2)(d) (and whether a breach of s 162(1) would then be inevitable as opposed to avoidable as VEAL 225 CLR 88 contemplated) until it performed its statutory task of considering the applications as submitted.

63    The Code expressly contemplated that the Authority would have to adopt procedures that moulded the requirement to inform an applicant under s 8S(2)(c) and (d) with the requirement under s 162(1) to protect from disclosure information that was commercially confidential. As Mason J, with whom Murphy, Aickin, Wilson and Brennan JJ agreed, said in O’Brien v Komesaroff (1982) 150 CLR 310 at 326-327:

… the accepted conception of confidentiality … involves the person seeking to protect the information largely keeping it to himself …

To simply say that the information is as to the effect and practical operation of discretionary trusts and private unit trust schemes does not identify the information and enable the Court to formulate an order. One needs to know not only what was the information conveyed but also what part of that information was not common knowledge. (emphasis added)

64    Ordinarily, once confidential information or a secret is released into the public domain, the quality of confidentiality is lost once for all: cf Attorney-General v Leveller Magazine Ltd [1979] AC 440; John Fairfax & Sons Ltd v Police Tribunal of New South Wales (1986) 5 NSWLR 465 at 480C-D per McHugh JA. There are four elements to a claim in equity to protect confidential information. These were identified by Finn, Sundberg and Jacobson JJ in Optus Networks Pty Ltd v Telstra Corporation Ltd (2010) 265 ALR 281 at 290 [39] (and see too Meagher Gummow and Lehane’s: Equity Doctrines and Remedies (5th ed) at [42-100]) as:

(1)    the information in question must be identified with specificity;

(2)    it must have the necessary quality of confidence [i.e. confidentiality];

(3)    it must have been received by the person to whom it was provided in circumstances importing an obligation of confidence; and

(4)    there must be an actual or threatened misuse of the information without the authority of the provider.

65    Obviously, s 162(1) supplants element (4), that Finn, Sundberg and Jacobson JJ identified, in prohibiting disclosure, but unless and until the Authority actually gets to the point of identifying some particular piece of information that Bayer provided years ago that still retains the quality of confidentiality, and that must be disclosed under s 8S(2)(d), s 162(1) can have no application to the facts.

66    Not everything that Bayer provided to the Authority in respect of the reference products was necessarily confidential commercial information either at the time of its provision over 10 years before, or remains so today: see Maggbury Pty Ltd v Hafele Australia Pty Ltd (2001) 210 CLR 181 at 202 [54] per Gleeson CJ, Gummow and Hayne JJ. Until the Authority considers what Bayer had provided in assessing whether the reference and proposed products satisfy the criterion in cl 1.2(3)(d), it cannot know what, if anything, in the information that Bayer had supplied, s 162(1) might prohibit disclosure of under s 8S(2)(c) or (d), if the Authority were to propose refusing either application. Moreover, at that point, when the particular information would be isolated, the Authority would have to attempt to mould its procedure to comply with the Code as a whole by both protecting any confidential commercial information but at the same time obeying the requirement in s 8S(2)(d). Only in the unusual situation, where a breach of s 162(1) would be inevitable, having regard to the principles in VEAL 225 CLR 88, would the Authority be required to consider re-categorising the applications in order to avoid what would be a demonstrable and otherwise unavoidable contravention of s 162(1).

67    The Authority has the function of determining whether or not it is satisfied about the matters in s 14 of the Code based on an application, initially at least, in the form as made to it (i.e. as s 14(1)(a) says it must be satisfied “that the application meets the application requirements”). The Authority specified in the Instrument certain matters that had to be included in an application pursuant to s 8B(1). The application had to be in writing on the approved form pursuant to s 8A(a)(i), that being, as defined in s 3, a form approved by the Authority or prescribed by the Regulations. No such form has been prescribed. However, the form Abbey used was drafted by the Authority for item 6.

68    Because the Authority gave Abbey a notice of preliminary assessment under s 11(2) that each application met the application requirements specified in s 8A, it follows that each application had been made, and fell to be considered, in accordance with item 6 in Pt 2 of Sch 6 of the Regulations.

69    As the reasons of each decision-maker noted, that consideration entailed the consideration of whether the proposed chemical product was “closely similar” to the reference product within the meaning of cl 1.2(3)(d) and item 6(a) of Sch 6. Each decision-maker identified that the only difficulty in considering whether each proposed chemical product was closely similar to the reference product arose in making a finding under cl 1.2(3)(d). Neither decision-maker stated that he or she had had access to, or considered, the Authority’s file in respect of the reference product.

70    Accordingly, neither decision-maker could have formed any view, let alone have known, that any information on such a file necessary to undertake the comparison required by cl 1.2(3)(d) was, first, confidential over 10 years after it had been provided by Bayer to the Authority and when both reference products had been, and aprapharm still was, on the market for many years and, so, available for testing by any member of the public. Secondly, neither decision-maker considered whether it was possible to decide whether to register or refuse to register each proposed chemical product and to give a notice, including if he or she proposed to refuse registration, in such a way as would accommodate the need to preserve any subsisting confidentiality of any particular information in accordance with s 162(1) and the statutory duty to give notices under s 8F(2), s 8G(2) or s 8S(2)(c) and (d).

71    Instead of performing those necessary functions for the purpose of making a decision on each of Abbey’s applications that had passed preliminary assessment under s 11(2), each decision-maker concluded that because it would be necessary merely to refer to unspecified confidential commercial information, a decision on each application necessarily would result in direct or indirect disclosure of some confidential information.

72    That conclusion involved a failure of the decision-maker, first, to perform the function of deciding each application under s 14 of the Code and, secondly, to take into account a relevant consideration – namely the need to examine the relevant information on the reference product files so as to ascertain what, if anything, might be confidential and then considering whether it was possible to proceed as VEAL 225 CLR at 99-100 [29] had explained.

73    For the reasons I have given, no disclosure of any confidential information could possibly occur if the Authority approved either application. That is because the bare statement that Abbey’s product would be registered could not convey on which of several bases under either limb of cl 1.2(3)(d) the decision-maker had determined that either of the two products was closely similar to the reference product. Moreover, the Register had recorded the active constituent of each reference product, as had their approved labels, for over a decade. That fact and the reference products themselves were in the public domain and had no element of confidentiality about them. And, if the decision-maker were to propose to refuse registration, he or she would need to give close, actual, consideration to how to perform the functions in s 8S(2)(c) and (d) without disclosure of anything that might be confidential: VEAL 225 CLR at 100 [29]. As I have explained, ordinarily it will be possible for the decision-maker to identify which one or more of the specifications or physico-chemical properties nominated in cl 1.2(3)(d) was not the same or equivalent and then to determine whether any such difference actually was confidential commercial information or was readily ascertainable by anyone examining the reference product. After that process, ordinarily the decision-maker will be able, if proposing to refuse or refusing an application to give reasons that state, as his or her finding of fact, merely that the relevant specifications or properties of the two products are not closely similar.

74    The application requirements that Abbey had to meet, for the purposes of s 14(1)(a), under item 6 of Pt 2 of Sch 6, were those set for an approved active constituent. Relevantly, the active constituents of both apramax and tetramax had been approved already. The decision-maker asserted in [24] and [25] of her apramax reasons that she needed to access Bayer’s confidential commercial information to determine whether the efficacy of aprapharm was closely similar to that of apramax. Yet, item 6(b) provided that efficacy and safety data were “not required to demonstrate the similarity of” apramax to the reference product. Instead, item 6(a) set out the criterion of the two products being closely similar as defined in cl 1.2(3) of Pt 2 of Sch 6.

75    That required relevantly that, first, the active constituents were the same as here (cl 1.2(3)(a)), secondly, the concentration of those constituents were the same (cl 1.2(3)(b)), which the decision-makers accepted, along with the matters in cl 1.2(3)(e)-(g), could be established on publicly available material, while cl 1.2(3)(c) was not relevant (see [24] of the apramax decision), and, thirdly, that the proposed and reference products’ specifications and physico-chemical properties were either the same or equivalent or, if not, the differences were minor and not expected to have adverse implications for product quality or biological activity in terms of efficacy, safety or residues (cl 1.2(3)(d)). Item 6(c) no doubt required the applicant to provide chemistry and manufacture data so that the Authority could assess the issues under cl 1.2(3)(d).

76    The decision-maker said (at [21] of the apramax decision), to her knowledge, that information concerning the specifications, composition and manufacturing process of the active constituent for the reference product were not in the public domain and that those factors related to the quality of the active constituent and affected its stability. If Abbey’s product had a material difference in its specifications, composition or manufacturing process from those of the reference product, and that difference affected either the quality of the active constituent or stability of Abbey’s product, all the decision-maker would need to disclose is the bare fact that there was the particular material difference in that general subject matter. Such a general disclosure (e.g. the specifications of the two products are not closely similar) could not convey any confidential information, let alone confidential commercial information.

77    Abbey provided a data package with each application that, among other matters, gave the results of a stability study in storage conditions of identified temperatures and relative humidities for the respective products in support of a requested shelf life. The Register recorded the approved labels for each reference product that also had specific storage and dosage strength information. The Register recorded that Aprapharm should be stored below 30ºC room temperature in a dry place and that 1.68g of aprapharm soluble powder equalled approximately “1g Apramycin activity”. The reference products either had or did not have closely similar stability to those in Abbey’s two applications. A statement of the Authority’s conclusion on that comparison would not reveal anything confidential to Bayer. That is because, if the two were closely similar, Bayer could only sell its products with the relevant stability data reflected in its storage conditions and use by date on the reference product’s label that Abbey’s product would also need to display on its label. And if the two were not closely similar in a particular respect, that finding of fact, ordinarily, would be a sufficient statement of the decision-maker’s reason for refusing, or proposing to refuse, the application.

78    Similarly, the level of potency or efficacy of a reference product as against the relevant product would either be, or not be, closely similar. That potency or efficacy could be ascertained by anyone testing the publicly available reference products. Disclosure of the fact that the actual degree of similarity was or was not “closely similar” would reveal nothing confidential to Bayer. The fact of a relevant difference, ordinarily, would be the information on which the reasons were based (within the meaning of s 8S(2)(c) and (d) of the Code). It would not be necessary for the decision-maker to identify the precise information in the Authority’s file about the reference product’s relevantly different specification or physico-chemical property. If an applicant wished to challenge those reasons, s 162(2) contemplates that the Authority’s file in respect of the reference product will be available for use in court proceedings in which appropriate orders can be made to protect anything that is confidential commercial information.

79    For example, the pH of a product that has been or is on the market would be likely to be readily ascertainable and have no quality of confidentiality. Just because the maker of a reference product may provide a pH value when it applied to obtain registration or approval of its product, did not entail that that pH value was confidential. A person, such as Abbey, could buy and test the reference product to ascertain its pH and identify that its value was the same or closely similar to the generic product the subject of its application. On the other hand, it may be that ascertaining differences, if any, in, say crystal form of the reference product, could give rise to an issue as to confidentiality. However, if it did, the decision-maker would be entitled to state that there were such differences in crystal form, so that the two products were neither the same nor equivalent. Such a statement would not reveal any secret or confidence about the crystal form of the reference product; it would reveal only that that form was substantively different from that of Abbey’s product and, hence, no contravention of s 162(1) would occur in such a statement.

80    This example demonstrates how the Authority did not exercise its jurisdiction and failed to ask itself the correct question or to consider a relevant consideration – namely that, if it actually needed to deal with a proposed refusal, whether it was still possible to disclose the matters required by s 8S(2)(c) and (d) conformably with s 162(1). Likewise, if the decision-maker was not satisfied that the differences referred to in cl 1.2(3)(d)(ii) were minor and or not expected to have the adverse implications specified, a statement of reasons, or information on which those reasons were based, would focus on the defects in Abbey’s products and would not be likely to involve any disclosure of Bayer’s confidential commercial information. The publication of the refusal would reveal only that whatever the respects in which there was a difference between the products, Abbey’s product possessed or failed to possess a publicly unstated particular specification or property, that disqualified it from being registrable on the basis of Abbey’s assertion that it was “closely similar” to the reference product.

81    It follows that the Authority failed to make a decision under s 14 of the Code and made a jurisdictional error by constructively failing to exercise its jurisdiction to decide Abbey’s two item 6 applications. Abbey is entitled to an order in the nature of a writ of mandamus under s 39B(1A)(c) of the Judiciary Act and s 23 of the Federal Court of Australia Act 1976 (Cth) compelling the Authority to determine each application according to law.

Consideration – the categorisation determination and the procedural fairness and competency issues

82    For the reasons above, the occasion never arose for the Authority to re-categorise each of Abbey’s applications and it erred in doing so. It is not necessary for me to decide the remaining three issues debated by the parties. However, I will briefly say why I consider that in each case the Authority erred. I have explained why there was no occasion to re-categorise the applications.

83    As VEAL 225 CLR 88 held, the Authority could have afforded, and had to, afford procedural fairness to Abbey before re-categorising the two applications. The consequence of any re-categorisation, as the Authority must have appreciated, was that Abbey would have to engage in a substantive, potentially lengthy and expensive process to obtain what ought to have been a simpler process to register, or have the Authority approve, its generic products.

84    Nor is the Authority’s objection as to competency sound. First, it gave a statement of reasons for its decision to re-categorise as that document stated, under reg 70B(1)(a). That regulation was an enactment within the meaning of “an Act” in par (a) and (c) of the definition of enactment in s 3(1) of the ADJR Act because it was made under the Code that formed part of the Agricultural and Veterinary Chemicals Code Act. Secondly, the decision-maker stated that her “decision” was she had “determined to re-categorise your application” under the power conferred by reg 70B(1)(a) and her statement of reasons commenced with the unambiguous: “The reasons for my decision are as follows”. Thirdly, the decision had substantive consequences because Abbey had to pay an increased fee, provide more information and wait a longer period for completion of the assessment of its application. In contrast to a power to re-categorise, by dint of s 11(4) of the Code, the Authority only had power to alter an application where, as here, it had passed preliminary assessment with the written consent of the applicant.

85    Thus, re-categorisation of an application is a decision that reg 70B authorised: Bond 170 CLR at 336. A decision to re-categorise an application has a substantive, not procedural, impact on the applicant. It can, and in Abbey’s case did, change, first, the nature of the criteria that Abbey had to meet in order to register its chemical products in order to satisfy s 14(1)(a) of the Code, secondly, the length of the assessment period and, thirdly, the fee it had to pay: Bond 170 CLR 337.

86    In substance, the Authority was refusing the applications under item 6 that Abbey had made and treating them, by force of reg 70B, as different applications that had to meet a different criteria to satisfy item 10. While the re-categorisation of an application pursuant to reg 70B is an intermediate decision along the way to a final decision to grant or refuse registration under s 14 of the Code, “it was a matter of substance for which the [Regulations] provided as an essential preliminary to the making of the ultimate decision”: Bond 170 CLR at 339. That is because it was essential for the Authority to make a decision on what it considered to be the correctly, or more correctly, categorised kind of application under reg 70B(1) pursuant to which it would decide how to exercise its power under s 14 of the Code.

87    And, as reg 70B(3)(a)(v) recognised, if a higher fee were payable, the applicant had a right to withdraw the re-categorised application upon being notified by the Authority of a decision under reg 70B(1). If a decision to re-categorise under reg 70B(1) were merely procedural, and not one of substance, it is difficult to see why the applicant had a right to withdraw an application and be entitled, under s 164(8)(b) of the Code, to seek from the Authority a reviewable decision as to whether it should receive a remission of the whole or part of the application fee that it had paid.

88    In effect, the decision to re-categorise an application under reg 70B(1) is a determination that the application as submitted does not meet the application requirements for the item in Pt 2 of Sch 6 under which it was lodged and that, instead, the applicant should have made the application under, and must now satisfy the requirements, of a different item.

Conclusion

89    As I have noted above the Authority relied on its solicitors’ letter of 23 December 2015 that offered Abbey the opportunity to make submissions as to why it ought not to have re-categorised each application. I am of opinion that, on the present material, had Abbey availed itself of that opportunity, nothing different to the Authority’s opposition to this proceeding would have ensued. Indeed, the Authority saw Abbey’s written submissions in chief dated 18 January 2016 and persisted with its opposition to the relief to which I have found Abbey is entitled.

90    For these reasons, the Authority should be ordered to determine the apramax and tetramax applications made under item 6 of Pt 2 of Sch 6 of the Regulations according to law and be given an opportunity, that it has sought, to argue why it should not be ordered to pay Abbey’s costs.

Associate:

Dated:    10 June 2016