Ground 5
63 Again, this ground puts ground 3 in a different way, that is, the third respondent took into account irrelevant considerations and failed to take into account relevant considerations. The former include the third respondent's opinion as to the outcome of the evaluation and the latter including that the applicant sought that the Voke Inhalator be evaluated as an over the counter medicine. I have already considered and dismissed at [21] above that part of ground 5 which claimed that there was an improper purpose or an abuse of process. It is not necessary to say anything further about ground 5.
64 I turn then to the central issue in the application, which is one of statutory construction, that is, the relation between s 23 and s 25 of the Therapeutic Goods Act.
65 There can be no doubt that the statutory obligation on the Secretary to evaluate therapeutic goods for registration under s 25 arises only where an application is made for the registration of those therapeutic goods "in relation to a person in accordance with section 23". But the present question is concerned with whether or not the application dated 29 June 2015 was such an application.
66 Contrary to the submissions of the respondents, I do not see that it assists analysis to inquire whether making an application in accordance with a form is a jurisdictional fact since the question is the proper construction of s 23 in context, which includes the general purpose and policy of the provision: Project Blue Sky Inc v Australian Broadcasting Authority [1998] HCA 28; 194 CLR 355.
67 Similarly, since the jurisdiction of the Court under s 39B of the Judiciary Act does not depend on there being a decision by an officer of the Commonwealth, Plaintiff S157/2002 v Commonwealth [2003] HCA 2; 211 CLR 476 per Gaudron, McHugh, Gummow, Kirby and Hayne JJ at [104], it is not essential to this Court's jurisdiction that s 23 does not in terms confer a power on a decision-maker. For this reason the third respondent should remain as a party, as responsible for the 16 October 2015 letter.
68 Hunter Resources Ltd v Melville [1988] HCA 5; 164 CLR 234, on which the respondents relied, concerned whether or not the mining warden was obliged to refuse an application for a prospecting licence when it was shown that the applicant had failed to comply with the marking out requirements of reg. 59 of the Mining Regulations 1981 (WA). That regulation required a mining tenement be marked out by fixing pegs in the ground "at intervals not exceeding 300 metres along each of the boundary lines". The majority held that the warden was so obliged: see at 245 per Wilson J; at 251 per Dawson J; and 257 per Toohey J. I do not regard the decision as of present assistance, apart from emphasising that the question is one of interpretation of the particular statutory provisions before the court.
69 Formosa v Secretary, Department of Social Security (1988) 46 FCR 117 was referred to by the respondents in support of an approach which asked what was the legislative intention as to the effect of non-compliance with a statutory requirement relating to the content of an application or the procedure for making it. Section 159(1) of the Social Security Act 1947 (Cth) required that a claim shall be made in writing in accordance with a form approved by the Secretary. The submission was that it was not fatal to Mrs Formosa's case that there was no claim by her in writing for an age pension in accordance with that section. The plurality, Davies and Gummow JJ, said at 124 that the requirement in s 159(1) that a claim shall be made in writing could not, consistently with the scope and object of the statute, be read as if a claim for a pension was sufficiently made if made orally at an office of the Department to an officer of the Department. The requirement that claims shall be made in writing was not to be characterised as a "mere matter of machinery for carrying out the undoubted purposes of the Act". Their Honours added that the facts of the present case did not show that any oral claim was made by Mrs Formosa for an age pension. Burchett J, in a separate judgment, at 126 agreed that the appeal should be dismissed and did so on the simple ground that Mrs Formosa did not in the relevant period make any claim for an age pension nor, indeed, for any other kind of pension. Therefore, the question whether such a claim, had it been made, would have been sufficient, if made orally, did not actually arise for decision. However, his Honour was unable to concur in the view that s 159 made it mandatory that a claim for a pension should be in writing. His Honour regarded the provision as directory only.
70 I do not regard this decision as of present assistance, not only because it deals with a quite different statute but also because it does not deal with a similar question to that which is before me: that is, it does not deal with whether, for example, if a person applied in writing for an age pension to which, it was assessed, she was not entitled, a lawful course would be for the relevant officer to say that the application was not made in accordance with the form approved by the Secretary.
71 Rodda v Repatriation Commission [2006] FCA 1689; 156 FCR 227 concerned the construction of s 155AC(2) of the Veterans' Entitlements Act 1986 (Cth) which provided that an applicant for review may authorise another person to represent him to respond to a statutory notice but that the authorisation must be in writing. It was held by Madgwick J that an "authorised" person's reply to a dismissal notice was of no effect where the applicant had only orally authorised the person to reply on his behalf: the oral authorisation given by Mr Rodda was not sufficient, such that the response to the notice was of no effect. The respondents relied on this decision to support the submission that the effect of non-compliance with a statutory procedure for an application is a question of legislative intention. I accept, of course, the general principle but I do not find the authority of any assistance where the question is not whether there has been an oral application where the statute requires a written application but whether a written application using a prescribed form is nevertheless non-compliant because there has been an assessment, not a statutory evaluation, and the assessment has concluded that what is being applied for on the prescribed form will not ultimately be granted.
72 The respondents also referred to Re LA (1993) 41 FCR 151 at 158 for the proposition that even if s 25C of the Acts Interpretation Act applied so that strict compliance with the form was not required and substantial compliance was sufficient, that provision was displaced because a contrary legislative intention appeared, conveyed by the use of the word "must", the context, and the evident legislative purpose. The case concerned an application to the Court under s 253M(1) of the Industrial Relations Act 1988 (Cth) which, by reg 98 of the Industrial Relations Regulations 1989 (Cth) "must be … in accordance with Form 11". Gray J held, at 158, that "in accordance with", in that context, meant in complete agreement with. His Honour also appears to have held, at 159, that the word "must" was clearly intended to carry a mandatory requirement and thus constituted a contrary intention to the application of s 25C of the Acts Interpretation Act. In the result, his Honour held that s 51 of the Federal Court of Australia Act 1976 (Cth) saved the proceedings from being invalidated since the provision extended to an "irregularity" and that word was broad enough to encompass failures to comply with mandatory provisions of regulations as to form.
73 In my opinion, Re LA does not assist with the present question, which is not one of strict compliance with a form but whether, as I have said, an application on an approved form may be treated as not being in accordance with s 23 because there has been an assessment, not a statutory evaluation, and the assessment has concluded that what is being applied for on the prescribed form may not or will not ultimately be granted.
74 Furthermore, the recent decision in MZAIC v Minister for Immigration and Border Protection [2016] FCAFC 25, especially at [43]-[50] is inconsistent with the apparent reasoning of Gray J in Re LA as to the significance of the word "must" and of the expression "in accordance with". MZAIC also indicates that s 25C of the Acts Interpretation Act reflects the common law so that it is not necessary, for the principle of substantial compliance to be applied, that an Act prescribes a form. It will be sufficient that, as in the present case, the Secretary approved a form.
75 MZAIC, particularly at [34], also stands against the correctness of the observation made by Finkelstein J in Onea v Minister for Immigration & Multicultural Affairs [1997] FCA 1472; 80 FCR 254, referred to by the respondents, that where there is more than one form and an applicant uses the incorrect form the applicant fails to make an application at all. In my opinion, the aphorism "No other form will do." used by Finkelstein J in Onea at 261 flows directly from his Honour's reference, earlier on that page, to the reasoning in Wu v Minister for Immigration and Ethnic Affairs [1996] FCA 106; 64 FCR 245 (under the name Wang) which was disapproved by the Full Court in MZAIC.
76 In resolving the central contention between the parties, it is important to bear firmly in mind that the issue is not whether the applicant's application for registration of the Voke Inhalator as therapeutic goods will or will not succeed, either at all or by reference to whether those goods are ultimately evaluated to be a prescription medicine in Pt 1 of Sch 10 to the Therapeutic Goods Regulations or evaluated to be a non-prescription medicine (over the counter) within Pt 3 of Sch 10.
77 What has so far been done by the Therapeutic Goods Administration is to make the assessment that the goods, the Voke Inhalator, are ultimately likely to be evaluated to be, or ultimately will be evaluated to be, in Pt 1 of Sch 10 and therefore there has been no application within s 23 because a different form is prescribed for goods which ultimately are assessed to be Pt 1 goods.
78 But this, in my opinion, is to be decided on evaluation under s 25. There is nothing flowing from the applicant's use of the approved form it used, to prevent the determination of the application, that being the relevant purpose of the requirement in s 23(1)(a). The applicant is contending that the Voke Inhalator is to be evaluated to Pt 3 not Pt 1 as a substance not mentioned in Sch 4 of the Poisons Standard as being within the exception to the definition of "nicotine" in that Schedule. The applicant's application under s 23 is made on that basis. To describe the issues in this way shows that the assessment of the ultimate correctness of the competing contentions is not to be made at the point of the correctness of the form used and thus the validity of the application for the purpose of s 23. As I have said, the application for registration by reference to Pt 3 of Sch 10 of the Therapeutic Goods Regulations may fail but that is quite different to saying that the application is not valid, even though it is made on the form approved for such goods, because the proleptic or anticipatory assessment has been made that, on evaluation, the goods would be registered by reference to Pt 1 of Sch 10.
79 Having so determined, it is not appropriate to accede to the parties' application that I should decide in these proceedings whether the definition of "oromucosal" in Pt 1 of the Poisons Standard should be read as if it meant "administration to the oral mucosa only". This seems to me to be a mixed question of fact and law and one which is not appropriate for me to decide merely on the documents, to which I was not taken in detail, and without additional evidence.
80 Similarly, I do not consider it appropriate in these proceedings to determine whether the Voke Inhalator is within the exception in the definition of nicotine in Sch 4 of the Poisons Standard. These are technical or scientific questions and they need to be decided in accordance with the statutory scheme, in the first instance, by the Secretary and then, if necessary, by a reviewable decision of the Minister and on external merits review by the Administrative Appeals Tribunal.
81 I come finally to the question whether the letter of 16 October 2015 was or evidenced an "initial decision" within the meaning of s 60 of the Therapeutic Goods Act. I have concluded that it was not such a decision because although there was a decision, at least in a non-technical sense, by the officer of the Therapeutic Goods Administration, Dr Kayali the third respondent, that the material lodged by Nicovations did not comply with the requirements of s 23(1)(a), this was not a decision of the Secretary of the Department or of the Secretary's delegate as referred to in the definition of "initial decision" in s 60. This is because, in my view, the Secretary was given no relevant decision-making power by s 23. For the reason given at [67] above, it is not necessary to determine whether the view taken by Dr Kayali was a decision within the meaning of the Administrative Appeals Tribunal Act or the Administrative Decisions (Judicial Review) Act but my provisional view is that Re Rennie and Kowalski, relied on by the respondents, are distinguishable and the position taken in the letter of 16 October 2015 had the necessary final or operative quality to be reviewable since the consequence was that the application would not be evaluated under s 25: see Australian Broadcasting Tribunal v Bond [1990] HCA 33; 170 CLR 321 at 335-338 per Mason CJ.
82 That the letter of 16 October 2015 was not or did not evidence an "initial decision" provides substantial support for the construction of the scheme of this part of the Therapeutic Goods Act that a position or conduct which involves an opinion as to the ultimate success of the application, but where there has been no evaluation of the goods under s 25, should not be made referable to whether or not the "correct" approved form has been used for the application.