Phytologic Pty Limited v the Secretary, Department of Health and Ageing, Commonwealth of Australia

Federal Court of Australia|2012-12-13|Before: Cowdroy J

Minister for Immigration and Multicultural Affairs v Yusuf (2001) 206 CLR 323 Padfield v Minister of Agriculture, Fisheries and Food [1968] AC 997 Re Brian Lawlor Automotive Pty Ltd and Collector of Customs (NSW) (1978) 1 ALD 167 Re Kearsley Shire Council;ex parte Hebburn Ltd (1947) 47 SR (NSW) 416 Shi v Migrations Agents Registration Authority (2008) 235 CLR 286 Wyeth Australia Pty Ltd v Minister for Health & Aged Care (2000) 61 ALD 372

Date of hearing: 22 November 2012

Division: GENERAL DIVISION

Solicitor for the Applicant: McLachlan Thorpe Partners

Solicitor for the First Respondent: Corrs Chambers Westgarth

IN THE FEDERAL COURT OF AUSTRALIA NEW SOUTH WALES DISTRICT REGISTRY GENERAL DIVISION NSD 1661 of 2012

AND: THE SECRETARY, DEPARTMENT OF HEALTH AND AGEING, COMMONWEALTH OF AUSTRALIA

DR KAYLENE RAYNES, DELEGATE OF THE SECRETARY, DEPARTMENT OF HEALTH AND AGEING, COMMONWEALTH OF AUSTRALIA

JUDGE: COWDROY J DATE OF ORDER: 13 DECEMBER 2012 WHERE MADE: SYDNEY

The Further Amended Originating Application be dismissed.
The Applicant pay the First Respondent's costs.
These orders be stayed until 4:00 pm Thursday 20 December 2012. Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

IN THE FEDERAL COURT OF AUSTRALIA NEW SOUTH WALES DISTRICT REGISTRY GENERAL DIVISION NSD 1661 of 2012

AND: THE SECRETARY, DEPARTMENT OF HEALTH AND AGEING, COMMONWEALTH OF AUSTRALIA

DR KAYLENE RAYNES, DELEGATE OF THE SECRETARY, DEPARTMENT OF HEALTH AND AGEING, COMMONWEALTH OF AUSTRALIA

JUDGE: COWDROY J DATE: 13 DECEMBER 2012 PLACE: SYDNEY

REASONS FOR JUDGMENT 1 By originating application filed on 26 October 2012 the applicant ('Phytologic') sought relief in respect of a decision of the respondent ('the Secretary') made under s 30(2)(ba) and (e) of the Therapeutic Goods Act 1989 (Cth) ('the TG Act') to cancel a listing on the Australian Register of Therapeutic Goods ('the Register') of a product described as Blooms Curcumin 600 Plus with Enhanced BioP Absorption ('the product') with effect from 29 October 2012. This decision will be referred to as 'the first decision'. 2 Relief was also sought in relation to a decision made by the Secretary on 23 October 2012to refuse a request made by Phytologic to extend the time in which the cancellation is to take effect ('the second decision'). 3 On 31 October 2012 an amended originating application was filed and on the first day of the hearing, the Court granted leave to Phytologic to file and rely upon a further amended originating application. In this application Phytologic seeks an extension of time for review of the first decision pursuant to s 11(1) of the Administrative Decisions (Judicial Review) Act 1977 (Cth) ('the ADJR Act'); and a review of both decisions.

FACTS 4 Phytologic sells and supplies the product which was listed on the Register by Phytologic on 18 March 2010. On 30 September 2010 a letter was sent by the Therapeutic Goods Administration ('the TGA') to Phytologic seeking details of the product. Such letter was responded to on 18 October 2010. 5 On 12 August 2011 Phytologic received a further inquiry from Dr Kaylene Raynes, Officer of Complementary Medicines at the TGA and Delegate of the Secretary of the Department of Health and Ageing ('the Delegate'), seeking information. Such letter was responded to on 26 August 2011. 6 On or about 11 November 2011 Phytologic received a notice of proposal to cancel the registration of the product on the Register from the TGA. Such letter raised concerns relating to the accuracy of statements made on the label affixed to the containers of the product and the scientific effect of the ingredients of the product. The letter gave reasons for the proposal to cancel the product's registration. In the letter, Phytologic was reminded that an applicant for listing of a product (on the Register) must hold information or evidence to support indications and claims made for the product as required by s 26A(2)(j) of the TG Act. Such letter was responded to by letter of Phytologic dated 12 December 2011. 7 By notice issued under s 30(3) of the TG Act, Phytologic was advised of the Secretary's intention to cancel the listing of the product pursuant to ss 30(2)(ba) and 30(2)(e) of the TG Act. Such subsections empower the Secretary, by notice in writing given to the person in relation to whom the therapeutic goods are included in the Register, to cancel the registration or listing of the goods if, inter alia, in respect of a product listed under s 26A of the TG Act, it appears to the Secretary that, for example, as provided by s 30(2)(e): The goods do not conform to a standard applicable to the goods or to a requirement relating to advertising applicable to the goods under Part 5-1 or under the regulations… 8 On 23 January 2012 Phytologic responded to the issues raised by the TGA in its letter of 22 December 2011. However the submissions contained in such letter were inadequate to satisfy the TGA's requirements, and by notice under s 30(3) dated 22 June 2012 Phytologic was notified of the proposal to cancel the listing of the product on the ground that the certification provided by Phytologic pursuant to s 26A(2)(c) of the TG Act was incorrect and additionally that the goods did not conform to the requirement relating to advertising applicable to goods under Part 5-1 of the TG Act or under the Therapeutic Goods Regulations 1990 (Cth) ('the Regulations'). 9 By letter dated 23 July 2012 Ms Annaliese Scholz, Regulatory Affairs Manager of Phytologic, responded indicating disagreement with the proposed course and referring to other drugs where it was claimed analogous advertising had taken place. 10 On 25 September 2012 the Delegate issued a Notice of Cancellation of Listing pursuant to s 30(2) of the TG Act of the product ('the cancellation notice'). The reasons for the decision were as stated above, namely incorrect certification under s 26A(2)(c) of the TG Act and failure of the product to conform to a requirement relating to advertising applicable to the goods under Part 5-1 or under the Regulations made pursuant to the TG Act. The notification was specified to take effect on 29 October 2012. 11 The decision contained in the cancellation notice (the first decision) referred to: the relevant legislation; the information which had been taken into consideration; the history of the case and material findings on fact. The date for cancellation was fixed to allow 20 days for the purpose of removing the product from sale. 12 The cancellation notice contained the following statement advising of review rights: Review of the decision under section 60 of the Act This decision is an 'initial decision' within the meaning of section 60 of the Act. This means that if your interests are affected by this decision, you may seek reconsideration by the Minister. Any request for reconsideration should be made in writing within 90 days after this decision first comes to your notice, or to the notice of your company, and should be sent to the following address: […] The letter should be headed: 'Request to review the decision under section 60 of the Therapeutic Goods Act 1989' 13 Section 60 of the TG Act provides for review of decision by the Minister administering the TG Act ('the Minister'). Section 60(2) states that a person whose interests are affected by an initial decision of the Secretary may, by notice in writing given to the Minister within 90 days of the decision being made, request the Minister to reconsider the decision. 14 Section 60(5) of the TG Act relevantly provides that following the consideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and stating that pursuant to s 28 of the Administrative Appeals Tribunal Act 1975 (Cth) an applicant may apply for a statement setting out the reasons of the decision and may, subject to that Act, apply to the Administrative Appeals Tribunal ('the Tribunal') for review of the decision, pursuant to s 60(8) of the TG Act. If the Minister does not respond to the request for review within 60 days of the request being received, the decision is taken as having been affirmed: see s 60(4) of the TG Act. 15 The cancellation notice stipulated that the cancellation was to take effect on 29 October 2012, namely within the time fixed by s 60 for review by the Minister. The first issue raised by Phytologic is whether an implied provision should be read into the TG Act to the effect that a decision made under s 30(2) cannot become effective until after a decision has been made by the Minister following a review pursuant to s 60 of the TG Act. 16 Before considering the submission raised on this issue, it is convenient to refer to the events subsequent to the first decision. By email sent from Ms Scholz to the Delegate on 11 October 2012 Phytologic requested confirmation that the listing of the product would not be cancelled prior to completion of the appeal process. 17 On 23 October the Delegate replied by email to the email of Ms Scholz, relevantly stating as follows: I indicated in the cancellation notice that I had decided that the cancellation would take effect on 29 October 2012 which provided you, the sponsor of the goods, with more than 20 working days from the receipt of the notice, to ensure that the goods were not unlawfully supplied (according to provision 19B(4) of the Act). The decision to cancel the listing of Blooms Curcumin 600 Plus with enhanced Bio P Absorption (AUST L 169976) has been made by me as the Delegate of the Secretary and will become effective on the 29 October 2012. You have the right to appeal my decision, which from your email you have taken up this opportunity. There is no provision under s 60 of the Act to stay the decision under review pending completion of this review and the initiation of the appeal process does not change the effective cancellation date for this medicine. I hope this information is of assistance and addresses your queries. 18 Phytologic challenges the decision made by the Delegate in her above email (i.e. the second decision) on the ground that she erroneously decided that she did not have power to amend or vary the first decision.

PHYTOLOGIC'S SUBMISSIONS 19 As to the first decision, Phytologic submits that the Delegate exercised her discretion under s 30(5)(b) to set the cancellation date of 29 October 2012 solely by reference to the consideration of giving Phytologic sufficient time to halt the supply of the product. Phytologic submits that such decision was ultra vires since, on a proper construction of s 30(5)(b) Parliament could not have intended to grant a power to determine a cancellation date before the Minister had determined a review request made under s 60 of the TG Act. 20 Phytologic claims that to allow for this process the cancellation should not take effect at least until 160 days after the decision was notified to the party affected. This period is the sum of 90 days (to seek reconsideration) plus 60 days (the period of the Minister's consideration), plus the reasonable time, suggested to be 10 days, to approach the Tribunal or a Court for a stay of the decision pending review. Phytologic submits that where a legislative scheme so clearly provides for a right of review and appeal, such matters form part of the policy and object of the ADJR Act and must not be subverted. 21 Secondly, Phytologic submits that having regard to s 5(2)(b) of the ADJR Act the Delegate failed to take into account relevant considerations, namely the statutory scheme for review; the fact that rights of review would be rendered nugatory if the listing was cancelled before the time had passed for such rights to be exercised; and that s 60 of the TG Act establishes a 'clearly adequate and appropriate review process': see Wyeth Australia Pty Ltd v Minister for Health & Aged Care (2000) 61 ALD 372 at [44]. The express statutory review scheme must be a relevant consideration to be taken into account in fixing the cancellation date. 22 Phytologic submits that there were no safety concerns regarding the product; there was no reason that cancellation should take effect before the review period expired; and that the cost and disruption to Phytologic would be substantial if it were required to withdraw the product and then seek to have it relisted after it successfully appealed. 23 Thirdly, Phytologic submits that the first decision was made for a purpose other than that for which the power was conferred; specifically that there could be no proper purpose for exercising the power to determine the cancellation date in such a way as to render Phytologic's review process nugatory. Phytologic submits that the Court must infer an improper purpose and relies upon Jilani v Wilhelm (2005) 148 FCR 255 at [87]. 24 Fourthly, Phytologic submits that having regard to s 5(2)(g) of the ADJR Act and the concept of unreasonableness as discussed in Associated Provincial Picture Houses Ltd. v Wednesbury Corporation [1947] 1 KB 223 ('Wednesbury unreasonableness') the decision was one which no reasonable decision-maker could have reached in view of the statutory scheme for review. Alternatively a legitimate expectation was created by the review process such that a party affected by the first decision would be given the benefit of the review process in a meaningful way. Phytologic relies upon the decision of the NSW Court of Appeal in Balmain Association v Planning Administrator for the Leichardt Council (1991) 25 NSWLR 615 at 632E. Phytologic submits that the cancellation date was unreasonable and further was an impossibly short time for Phytologic to have the benefit of such rights. 25 Phytologic's submissions concerning the second decision will be referred to subsequently.

(a) Was the Delegate's decision ultra vires? 26 Under this ground Phytologic submits that the selection by the Delegate of the date for cancellation of the listing for the product was based upon an absence of power. Put in the language contained in the provision of s 5(1)(d) of the ADJR Act, the decision was not authorised by the enactment (i.e. the TG Act) in pursuance of which it was purported to be made. 27 Section 30(5) of the TG Act provides: Where the Secretary cancels the registration or listing of goods in relation to a person, the good cease to be registered or listed: (a) if the cancellation is effected under subsection (1), (1A) or (1C) - on the day on which the notice of cancellation is given to the person; or (b) in any other case - on such later day as is specified in the notice. 28 Accordingly where a notice is issued under s 30(5)(a) of the TG Act, in reliance of a ground referred to in s 30(1), the effect of the decision is immediate, in the sense that as soon as the notice is provided to the recipient, the cancellation is effective. There are various instances in which the Secretary may cancel the registration immediately. Those instances may be summarised as comprising situations in which there is the potential for immediate harm to be occasioned by virtue of such medicines being available to the public. 29 In all other instances, the delegate has a discretion in setting the date when the cancellation notice becomes effective. This applies to the first decision. It is essential for a proper exercise of the power that the notice specify a date for cancellation. 30 In the exercise of the power provided by s 30(5)(b) a cancellation notice must fix a date on which cancellation would become effective. Obviously such date is necessary for certainty and to inform the affected party so that arrangements might be made to implement the cancellation. The Explanatory Memorandum for the Therapeutic Goods Bill 1989 (Cth) was no doubt directed to these ends when it stated: … Cancellations made under subclause 30(1), which include cancellations made in more urgent circumstances, are effective immediately. In other cases, the date of effect is to be specified in the notice of cancellation (subclause 30(5)). 31 As already referred to, the Delegate allowed over 20 working days from the date of receipt of the first decision to enable Phytologic to take steps to remove the goods from sale. This was specifically stated by the Delegate in the cancellation notice as the reason for the determination of the cancellation date. 32 There is no provision contained in the legislation which suggests that there was any requirement that the Delegate is required to determine the date for cancellation only after the review period had taken effect. Phytologic submits that if the decision, on review, were upheld it would need to take steps to relist the product. However based, upon the findings in Re Brian Lawlor Automotive Pty Ltd and Collector of Customs (NSW) (1978) 1 ALD 167 ('Lawlor's Case') at 175-6 per Brennan J and Shi v Migrations Agents Registration Authority (2008) 235 CLR 286 at [100] per Hayne and Heydon JJ, it may be that if the decision to cancel is revoked, the initial cancellation and its effective date are nugatory, making it unnecessary for Phytologic to re-register the product. The TG Act contains no provision directed to this circumstance, and for present purposes it is unnecessary to determine this question. 33 Section 19B(4) makes it an offence to import, export, manufacture or supply therapeutic goods in Australia which are not included on the Register (and which are not exempt from the requirement for registration) and s 19D(1) authorises the imposition of civil penalties for contraventions. 34 Whilst it is correct that the date specified in the cancellation notice, namely 29 October 2012, would have the effect that the cancellation takes place before the right of review period prescribed by s 60 has expired, such circumstance is irrelevant when the structure of the TG Act is considered.

(b) Failure to take into account relevant considerations 35 As to the assertion that the Delegate failed to take into account relevant consideration, namely that the right of appeal was to be exercised prior to the cancellation taking effect, Phytologic first submits that the Delegate was required to consider the review period before determining the date of cancellation; there was no reason to cancel the registration prior to the expiry of the review period under s 60 in the absence of any safety concerns; and that the cost of disruption to Phytologic of ceasing to market the product will be substantial. 36 Subsections 30(1) and 30(2) state the matters which are to be taken into consideration before making a decision to cancel the registration of any product. Section 30(4) specifically provides that where a person makes submissions as provided by s 30(3)(b) against cancellation, the Delegate is not to make a decision until the submissions have been taken into account. The section does not require the Delegate to provide priority to any particular considerations. 37 Secondly, Phytologic submits that the review notification set out in the cancellation notice cannot be treated as part of the decision, since in the decision under the heading 'Relevant legislation' the Delegate stated the relevant legislation for the purpose of her decision. It referred to the provisions of various subsections within s 30 but no reference was made to s 60 of the TG Act. 38 Further, the structure of the decision contains paragraphs commencing with a letter of the alphabet to indicate the next paragraph. However, the review notification is contained within a paragraph which has no alphabetical prefix. Accordingly, Phytologic submits that inclusion of such paragraph is merely lip service to the requirement in s 60(6) and does not indicate that the Delegate took the existence of review rights into account in her decision. 39 As to Phytologic's submission that, in the absence of safety concerns, there is no reason to select a cancellation date prior to the date of the expiration of the review period, the fact that the date for the cancellation may take effect prior to the exhaustion of the period is a matter solely for the discretion of the Delegate. Phytologic exercised its right of review by lodging its Application for Review on 28 September 2012; three days after the date of the decision to cancel the registration of the product. Accordingly Phytologic exercised its rights under s 60. It is possible, but not certain, that the Minster may have been able to provide a decision prior to 29 October 2012 in which event the right would have been available to Phytologic to instigate review in the Tribunal for a reconsideration and to seek a stay in that jurisdiction before 29 October 2012. However, the fact that this possibility might have come to pass is not a reason to uphold the submission that the Delegate was bound not to fix a cancellation date earlier than the expiration of right of review period. 40 Similarly, it should be observed that the consideration referred to by Lord Reid in Padfield v Minister of Agriculture, Fisheries and Food [1968] AC 997 ('Padfield') does not assist. Lord Reid discussed at 1030 the creation by Parliament of a system for investigating and determining whether a fish marketing scheme was operating in the public interest. At 1033 his Lordship referred to the principle expounded in Julius v Bishop of Oxford (1880) 5 App. Cas. 214. That principle provides a warning that the exercise of an unfettered discretion may give rise to a duty to exercise the power appropriately. However, in the instant case, there is nothing to suggest that the Delegate, in determining the cancellation date, has acted beyond the power, or acted contrary to such power and consequently the Delegate has observed the duty stated in Padfield. 41 For the above reasons, the Court rejects the submission of Phytologic that there was a legislative intention demonstrated to the effect that a party affected by cancellation under s 30(2)(ba) or s 30(2)(e) is entitled to have the review period exhausted before any decision to cancel comes into operation. 42 The Court now addresses the submission that the Delegate did not consider the operation of the review process in reaching the decision. The Court observes that the notice of cancellation states: the reasons for the decision; the action required to be taken by Phytologic; the relevant legislation; the information taken into account; the history of the case; the material findings of fact; and the conclusions followed by the notice. 43 The Court also notes that Phytologic's interpretation of the TG Act would create uncertainty in determining the date of cancellation of registrations. In some cases a person notified of a cancellation decision would quickly make an application for review to the Minister, while in other cases a person may take the full 90 days. In some cases a Minister would be able to determine a review application quickly, while in other cases the Minister may need the full 60 days to consider it. There would be no way of telling in every instance how much time was required for the review process to take effect and Phytologic's proposal would render the date of effect of cancellation decisions wholly arbitrary. 44 Further, the Court considers that the Delegate, when she made the first decision, was aware of the period in which Phytologic could seek a review. The fact that notification of review rights by the Delegate took the form of a pro forma statement at the end of the decision does not establish any inference to the contrary.

(b) Absence of safety concerns 45 Phytologic submits that the absence of any concern for the safety of the product means that there was no reason to cancel registration before the review process was completed. 46 A listing of a medicine on the Register is initiated by a sponsor (in this instance, Phytologic). Pursuant to s 26A(2) the sponsor must certify numerous matters including that the medicine is eligible for listing (s 26A(2)(a)); that the medicine is safe for the purposes for which it is to be used (s 26A(2)(b)); that the presentation of the medicine is not unacceptable (s 26A(2)(c)); and that the medicine applies with all prescribed quality or safety criteria that are applicable to the medicine (s 26A(2)). As to the labelling, specific provisions apply under s 26A(2)(fb). In summary, the medicine label is required to comply with any requirements prescribed by the regulations; and the label must not make a claim which is inconsistent with any claim made by the application in relation to the medicine (see s 26A(2)(fb)(i) and (ii)). By s 30 cancellation of registration may be effected by the Secretary. 47 It is apparent that the provisions of the TG Act are designed to implement its objects. These objects extend beyond safety, but also include accuracy in information and advertising relating to medications. These factors also influence the setting of the date of cancellation. In this respect, the considerations relevant to the exercise of the Secretary's power to cancel essentially determine the matters to be taken into consideration: see Minister for Aboriginal Affairs v Peko-Wallsend Ltd (1986) 162 CLR 24 at 40; see also Minister for Immigration and Multicultural Affairs v Yusuf (2001) 206 CLR 323. 48 The discretion granted to the Delegate to determine the date upon which cancellation was to be effected is unconstrained. In view of the Delegate's concerns about the classification of ingredients of the product, and of claims made on the labelling which, to the Delegate, could not be confirmed, the Court rejects the submission that the Delegate failed to take into account a relevant consideration concerning the timing of the cancellation when making the decision to cancel. These concerns provide a valid ground for cancellation of registration under s 30(2).

(c) Commercial considerations 49 As a third example of the Delegate's failure to take into account a relevant consideration, Phytologic refers to the cost and disruption it will suffer by withdrawing the product and then reintroducing it to the market in the event of a successful review. There is evidence before the Court which suggests that it will be commercially inconvenient for Phytologic to remove a medicine from sale prior to the expiration of the cancellation period and then to remarket such medicine in the event of a successful review. 50 The TG Act does not refer to any consideration of a commercial kind which the Delegate was obliged to consider prior to making the decision to cancel. The considerations and objects of the TG Act relate to ensuring a product's safety and accuracy in description, not its commercial impact or market position. In the absence of any provision which might suggest that commercial considerations were to be taken into account prior to a cancellation decision being made, there is no basis for implying such provision. The Court rejects the submission that commercial considerations were in any way relevant to determining the date of the notice. 51 Lastly, Phytologic submits that the length of time 'limited by the Act for the operation of the statutory scheme for review of the first decision' was a matter which was not taken into account by the decision-maker. 52 The Court has already referred to the statutory scheme under the provisions relating to the ultra vires submission. There is no need to repeat the matters referred to therein. The Court reiterates that the Delegate took the matter of review rights into consideration when the cancellation date was selected.

(d) Improper purpose 53 Phytologic submits that the power conferred by s 30(2) of the TG Act was used for a purpose other than the purpose for which such powers were conferred. The particulars of such submission relate to the issue of that failure to take into account relevant considerations. Phytologic submits that review rights were 'effectively curtailed' and that such is evidence of an improper purpose. Phytologic relies upon Jilani v Wilhelm at [87] in support of its proposition that there could be no proper purpose in exercising the power in s 30(5)(b) in such a manner as to render Phytologic's review rights nugatory. 54 In Jilani v Wilhelm, the Full Court observed at [87]: Where improper purpose is alleged, it will usually be necessary to state that purpose. However in some circumstances it may be sufficient to allege that demonstrated absence of a proper purpose leads to the inference of an improper purpose. That was the approach adopted by the applicants in this case. In effect they asserted that the only possible proper purpose (conduct of an investigation) was excluded by the available inference that the investigation had been completed. However we have concluded that that such inference was not available. Thus it is not possible to exclude proper purpose. 55 The inference which is sought to be drawn by the applicant is inconsistent with the Delegate's reasons. Having formed a view that the certification provided by Phytologic under s 26A(2)(c) of the TG Act was incorrect and that the product did not conform to a requirement relating to advertising applicable to the goods under Part 5-1 or under the Regulations, the Delegate then allowed 20 working days from receipt of the notice to ensure that the supply of the product ceased in an orderly manner. A period of time to allow customers and producers to transfer away from a medication has been a relevant factor in setting a cancellation date in other cases such as Aspen Pharmacare Australia v Minister for Health and Ageing [2012] AATA 93. 56 The Delegate referred to the provisions under s 19B(4) and the civil penalties under s 19D(1). In allowing the 20 day working day period from receipt of the notice, the Delegate was mindful (as stated) that such period would permit the goods to be withdrawn and thereby avoid Phytologic potentially committing an offence and being liable for civil penalties. In these circumstances, there is no basis for the submission that the decision was made to curtail the review rights to which the Delegate expressly drew attention in the first decision. 57 Had the cancellation by the Delegate frustrated Phytologic's right of review, there would be scope to consider the application of the above principle. But the cancellation had no such effect, and since the review rights were continued, and were availed of by Phytologic, there is no basis for the submission of improper purpose.

(e) Wednesbury unreasonableness 58 Phytologic submits that the first decision was so unreasonable that no reasonable person could have exercised the power to require cancellation prior to the expiration of the appeal rights and further submits that s 60 gave rise to a legitimate expectation that the cancellation would not occur before the expiration of those rights. In Balmain Association the Minister exercised a power provided by a NSW statute (the Environmental Planning and Assessment Act 1979 (NSW)) requiring a council to perform all of its functions and to submit four draft local environmental plans within five weeks of such direction. It was in fact impossible for the Council to comply with its functions under s 68 of that Act within the specified period. On this ground the direction was held to be unreasonable in the Wednesbury sense. 59 As stated previously, the cancellation date was directed to the sole issue of enabling Phytologic to cease sales of the medicine in an orderly manner. Such direction did not impact upon the rights of review which remained unaffected. Accordingly, there is no ground for finding that the decision was Wednesbury unreasonable. Further, there is no provision contained in s 60 which requires the Delegate to determine a cancellation date after the Minister had completed a review under s 60. In these circumstances, no basis exists for the legitimate expectation as claimed. 60 As there is no other basis suggested for the ground of Wednesbury unreasonableness, the Court dismisses such ground. 61 Accordingly, the Court summarises its conclusions on the first decision. First, there is total discretion provided to the Secretary for the selection of the date when the cancellation is to take effect. Secondly, the statutory right of review by s 60 remains intact irrespective of whether the cancellation has taken place or will take place at some later date after the review period has concluded. There is nothing in the legislation which warrants a construction that the cancellation will take place only after the review period has been exhausted. The Delegate was not obliged to take into account the financial impact of a decision to cancel on Phytologic. No doubt the discretion was provided to the Secretary in view of the numerous factual situations which might arise requiring action to be taken to cancel the licence any time after the notice was given to the relevant person. Accordingly the Court rejects the contention that the conduct of the Delegate was beyond the powers provided to her by the TG Act.

SECOND DECISION 62 As stated above at [16]-[18], the Delegate in her second decision stated that she did not have power under the TG Act to amend the cancellation date once she set it. Phytologic submits that this decision suffers from an error of law for the purpose of s 5(1)(f) of the ADJR Act. The alleged error of law is the failure of the Delegate to realise that the date of the delisting could have been rescinded, revoked, amended or varied under s 33(3) of the Acts Interpretation Act 1901 (Cth) ('the Interpretation Act'). Such section relevantly provides: (3) Where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws) the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument. 63 There are two elements that must be established before s 33(3) of the Interpretation Act can be said to apply. First, the decision must concern the making of an instrument of legislative or administrative character. Second, pursuant to s 2 of the Interpretation Act there must be no contrary intention in the TG Act which would preclude the operation of s 33(3) of the Interpretation Act. 64 With respect to the first element, the respondent submits that the only factor which could be considered to be an instrument is the notice of cancellation which the delegate is obliged by s 30(2) to provide to the person in relation to whom the product is registered. The respondent submits that in giving the notice, the delegate had already made a decision to cancel and the notice is merely a written confirmation of this decision. Therefore, it is not an instrument and s 33(3) of the Interpretation Act does not apply. 65 The respondent's argument is similar to the reasoning adopted by the Full Court in Lawlor's Case. In Lawlor's Case the respondent was granted a licence to operate a bonded warehouse pursuant to s 78 of the Customs Act 1901 (Cth) ('the Customs Act'). The appellant subsequently decided to revoke that licence on the basis that Mr Lawlor was not a fit or proper person to hold a licence. There was no specific power in the Customs Act for the licence to be revoked. One of the questions for the Court's consideration was whether s 33(3) of the Interpretation Act resulted in a power of cancellation being implied. 66 Bowen CJ noted at 3 that a licence under s 78 of the Customs Act could be granted either orally or in writing. Section 33(3) of the Interpretation Act only applied to a power, not the means by which the power is exercised. Similarly, Smithers J stated at 12-13: Section 33(3) is designed to confer a power of revocation of an instrument made, granted or issued by an authority pursuant to a power already conferred upon it to make, grant or issue that instrument in circumstances where the power of revocation may not otherwise have been conferred upon that authority. The sub-section is clearly concerned with instruments which, when made, granted or issued by an authority achieve some legal result because they were made, granted or issued pursuant to the power conferred upon the authority to make, grant or issue them. There is a distinction between conferring a power to make, grant or issue an instrument which pursuant to the power conferred will create particular legal rights or liabilities and conferring a power on an administrator to create legal rights and liabilities, by, for instance, granting a licence or entering into a contract by appropriate action according to law. The distinction is greater where the power to create particular legal results is conferred and nothing is said about the manner of creating the authorized result. In such a case it would seem that all that is intended is to confer power and authority to grant the licence or make the contract, the exercise of that power and authority to proceed according to law by whatever legal means are available to the authority according to its personality and capacity. Where this is the situation it cannot be said that the legislature has directed its attention to the means of achieving the authorized legal result, much less that it has conferred power to make, grant or issue an instrument. […] In relation to Div 1 of Pt V of the Customs Act it may be concluded that its provisions are not provisions with respect to the making, granting, or issuing of instruments merely because the exercise of the powers conferred therein might be carried out by issuing an instrument. 67 Accordingly, the Court found that s 33(3) of the Interpretation Act did not apply. 68 However, in Edenmead Pty Ltd v Commonwealth of Australia (1984) 4 FCR 348 ('Edenmead'), Spender J distinguished Lawlor's Case in an important respect. The facts of that case are instructive. The applicant owned a fishing trawler which was fishing off the Queensland coast. At the time, s 8(1)(d) of the Fisheries Act 1952 (Cth) ('the Fisheries Act') entitled the Minister for Fisheries to prohibit fishing of specific types of fish in specific waters (with some exceptions, which are not relevant). The section relevantly stated: The Minister may, by notice published in the Gazette, prohibit fishing in an area of proclaimed waters in respect of fish included in the class of fish specified in the notice… 69 The Minister decided to prohibit prawn fishing off the Capricorn Coast and on 4 November 1983 published a notice in the Gazette to that effect. 70 On 15 June 1984 the Fishing Legislation Amendment Act 1984 (Cth) ('the Amendment Act') came into effect. The Amendment Act removed s 8(1)(d) of the Fisheries Act. 71 On 30 October 1984, the Minister published a notice in the Gazette which varied the previous notice (made under the unamended Fisheries Act), to include a prohibition on fishing for scallops in the relevant area. The applicant claimed that the Minister had no power to vary the instrument, because the new statute no longer provided for such an instrument to be made. The Commonwealth submitted that the Minister did have power, because s 33(3) of the Interpretation Act applied. The applicant argued that the power being exercised by the Minister in varying the notice was simply 'a power to do something, namely, to prohibit, and therefore s 33 of the Acts Interpretation Act did not apply'. 72 Spender J considered that the key question was whether the exercised power came within the description of 'a power to make, grant or issue any instrument'. Spender J followed Smithers J's approach in Lawlor's Case where Smithers J stated that the question is answered by characterising the power. Spender J noted at 352 that 'the mere form or grammatical expression in which a power is conferred is not determinative of its true characterisation'. Spender J also noted at 352 that, according to the applicant's argument, if the Fisheries Act stated 'The Minister may publish a notice in the Gazette prohibiting the fishing for scallops', then s 33(3) would apply, but if the Fisheries Act stated that 'The Minister may, by notice published in the Gazette, prohibit the fishing for scallops' then it would not. Spender J did not accept this semantical argument. 73 Spender J stated at 353: It was submitted by senior counsel for the Commonwealth that Lawlor's Case is distinguishable, and I agree with that submission. The crucial distinction is that the power under the Customs Act 1901 with which Lawlor's Case was concerned conferred a power which may or may not be exercised in writing. The existence of a document in writing was not a necessary condition to the exercise of a power conferred by that section of the Customs Act 1901 and indeed conferred quite indirectly by that provision. The existence of any writing was a possible incident to the exercise of that power but was by no means a necessary condition. It follows therefore that the conferral of such power cannot, on a proper characterisation, be construed as a power to grant, issue or make an instrument. In addition, there are other factors which serve to distinguish the conclusion reached in Lawlor's case from the conclusion which ought properly to follow in this case. Here the publication of the instrument is essential to the valid exercise of the power. It is… the very act by which the power is exercised and conceptually there is no distinction to be drawn between the publication of the notice and the exercise of the power. 74 At 353 Spender J distinguished the case before him from Lawlor's Case on a further ground, namely, the revocation of the licence in Lawlor's Case deprived an individual of an existing right, whereas the Minister's decision in the present case merely restricted the general liberty to fish and did not remove an individual right. Spender J also observed that the applicant's construction would lead to the absurd consequence that Parliament could not amend notices issued pursuant to the Fisheries Act without passing a subsequent Act of Parliament. Accordingly, his Honour found that s 33(3) of the Interpretation Act did apply to allow the Minister to amend the notice. 75 Consideration of s 30(2) of the TG Act leads the Court to conclude that the present circumstances are analogous to Edenmead. The critical words in s 30(2) are: 'the Secretary may, by notice in writing given to a person...' (Emphasis added). The section states that it is not possible for the Secretary to cancel registration pursuant to s 30(2) without issuing such a notice. The decision made by the delegate to cancel registration is therefore inherent within the issuance of the notice of cancellation. This provision is identical to the provision of the Fisheries Act considered in Edenmead, in which the decision made by the Minister to prohibit certain types of fishing was found to be inherent within the issuance of the notice in the Gazette. Therefore, for the same reasons as in Edenmead, the notice of cancellation issued by the delegate is an instrument of administrative character. 76 The next question is whether the TG Act evinces a contrary intention to the application of s 33(3) of the Interpretation Act. The respondent submits that the availability of review rights pursuant to s 60 of the TG Act indicates such an intention. The respondent first submits that if a person is aggrieved with a decision made by a delegate pursuant to s 30(2) of the TG Act, then the appropriate course is for the aggrieved person to apply to the Minister for review pursuant to s 60, rather than to apply to the delegate for reconsideration. The availability of this avenue demonstrates that Parliament did not intend for delegates to have the power to amend or cancel their decisions once made. Any such power would be exercised by the Minister. 77 In Comptroller-General of Customs v Kawasaki Motors Pty Ltd (No 2) (1991) 32 FCR 219, Beaumont J stated at 225-226: Some administrative decisions, once communicated, may be irrevocable. But where it appears to a decision-maker that his or her decision has proceeded upon a wrong factual basis or has acted in excess of power, it is appropriate, proper and necessary that the decision-maker withdraw his or her decision. In Rootkin v Kent County Council [1981] 1 WLR 1186; [1981] 2 All ER 227, Lawton LJ said (at 1195; 233): It was submitted to us on the authority of a number of cases, of which the last in order of time was Re 56 Denton Road, Twickenham, Middlesex [1953] Ch 51 … that what the divisional education officer was doing was making a determination and, having once made a determination, he was not entitled to go back on it. In my judgment, that is a misconception. It is the law that if a citizen is entitled to payment in certain circumstances and a local authority is given the duty of deciding whether the circumstances exist and, if they do exist, of making the payment, then there is a determination which the local authority cannot rescind. That was established in Livingston v Westminster Corp [1904] 2 KB 109 … But that line of authority does not apply in my judgment to a case where the citizen has no right to a determination on certain facts being established, but only to the benefit of the exercise of a discretion by the local authority. The wording of s 55(2) [of the Education Act 1944 (UK)] is far removed from the kind of statutory wording which was considered in Re 56 Denton Road, Twickenham (supra) and Livingston v Westminster Corp (supra). I cannot, for my part, see any basis for the submission that the decision of the divisional education officer in July 1976 was irrevocable when he found out what the true facts were. Rootkin's case (supra) was followed in Jones v Commissioner of Police (1990) 20 ALD 532 at 533. 78 This suggests that, at least in limited circumstances, a decision-maker has the ability to rescind or amend a decision, provided that such decision is not irrevocable. 79 In Heslehurst v New Zealand (2002) 189 ALR 99, Emmett J considered that the availability of a statutory review mechanism in s 35 of the Extradition Act 1988 (Cth) did not establish a contrary intention such that s 33(3) of the Interpretation Act did not apply to an extradition warrant. His Honour stated at [32]-[33]: Either way, I do not consider that the presence of s 35 gives rise to an intention sufficient to exclude the operation of s 33(3) in relation to a warrant issued under s 34 of the [Extradition Act 1988]. Further, if the contrary conclusion were reached, there would be, to use the words of Spender J, "startling consequences". Those startling consequences are relevant to the question of whether or not a contrary intention appears. If there were no power to amend the warrant in relation to the identity of the New Zealand escort officer, the court's order pursuant to s 34(1) could be effectively nullified simply because of the unavailability of the person identified. That could have the effect that extradition is frustrated simply because of the delays that are inherent in the review and appeal processes conferred by the Act. Certainly those processes are constrained. For example, an application under s 35 must be made within 15 days after a magistrate's order. An application to the Full Court must be made within 15 days after the decision of the judge at first instance. Nevertheless, there is a necessary delay involved in the hearing and decision making process. It may be arguable that the non-availability of a New Zealand escort officer would constitute a reasonable cause under s 38(8)(b) for the failure to execute the warrant, so that the court could order that the person in question not be released from custody. Without the power to amend, a person could, on one view, remain in custody indefinitely simply because of the impracticabilities of executing the warrant. Those consequences are another reason why one would not construe the Act as evincing an intention to exclude the operation of s 33(3). 80 For similar reasons, the Court finds that the statutory review provided by s 60 of the TG Act does not exclude the operation of s 33(3) of the Interpretation Act. There are circumstances in which a delegate may wish to amend his or her decision made under s 30(2) of the TG Act. An example of this might be where a delegate has made a blatant factual error, which is then brought to the attention of the delegate. It may be that the delegate considers it prudent to rectify such error by amending or revoking and reissuing the decision prior to the Minister making a decision after a request for review pursuant to s 60 of the TG Act. There may be other possible scenarios in which the delegate would amend a decision prior to ministerial review, but suffice to say the power under s 33(3) of the Interpretation Act may apply in some circumstances. 81 The next feature of the TG Act which the respondent submits establishes a contrary intention is s 30A, which states: Revocation of cancellation of registration or listing upon request (1) If: (a) the Secretary cancels the registration or listing of therapeutic goods because of the request of a person made under paragraph 30(1)(c); and (b) before the end of the period of 90 days beginning on the day the goods ceased to be registered or listed, the person requests, in writing, the Secretary to revoke the cancellation; and (c) the request is accompanied by the prescribed application fee; the Secretary may, by notice in writing given to the person, revoke the cancellation. 2. If the cancellation is revoked, the cancellation is taken never to have occurred. 82 The respondent submits that the specific provision for the delegate to amend its decision indicates Parliament's intention that the circumstances referred to in s 30A of the TG Act are the only circumstances in which a decision should be amended or revoked by a delegate. 83 This submission does not follow. There is nothing within s 30A which states that these are the only circumstances in which a cancellation power may arise. Section 30A also deals with a very different and specific type of scenario, namely one in which the cancellation process is initiated by a person responsible for a registration. It does not say anything about a situation where the cancellation process is initiated by a delegate. 84 Accordingly, the Court finds that there is no contrary intention which would preclude the operation of s 33(3) of the Interpretation Act to a cancellation notice issued pursuant to s 30(2) of the TG Act. 85 What consequences should follow from this finding? From the email written by Dr Raynes referred to in [17] above, it appears that she has not considered that s 33(3) of the Interpretation Act provided her with a power to revoke or amend her decision. In Craig v South Australia (1995) 184 CLR 163 at 179, Brennan, Deane, Toohey, Gaudron and McHugh JJ stated with reference to a decision erroneously made by an administrative tribunal: If such an administrative tribunal falls into an error of law which causes it to identify a wrong issue, to ask itself a wrong question, to ignore relevant material to rely on irrelevant material or, at least in some circumstances, to make an erroneous finding or to reach a mistaken conclusion and the tribunal's exercise or purported exercise of power is thereby affected, it exceeds its authority or powers. Such an error of law is jurisdictional error which will invalidate any order or discretion of the tribunal which reflects it. 86 Similarly, see Anisminic v Foreign Compensation Commission [1968] 2 AC 147 at 171. 87 Further, Jordan CJ stated in Re Kearsley Shire Council; ex parte Hebburn Ltd (1947) 47 SR (NSW) 416 at 423: If the statutory provisions are disregarded by consideration of extraneous matters or owing to a misinterpretation in mistake of the law there is either a wrongful assumption or refusal of jurisdiction as the case may be. 88 It is clear that in considering Phytologic's request for the cancellation decision to be postponed pending consideration of the request for review by the Minister, the Delegate reached an erroneous conclusion that she had no power to amend such decision, when s 33(3) of the Interpretation Act provided such a power. This is an error of the type specified in Craig v South Australia. 89 However, s 10(2)(b) of the ADJR Act states: (b) the Federal Court or the Federal Magistrates Court may, in its discretion, refuse to grant an application under section 5, 6 or 7 that was made to the court in respect of a decision, in respect of conduct engaged in for the purpose of making a decision, or in respect of a failure to make a decision, for the reason: (i) that the applicant has sought a review by the court, or by another court, of that decision, conduct or failure otherwise than under this Act; or (ii) that adequate provision is made by any law other than this Act under which the applicant is entitled to seek a review by the court, by another court, or by another tribunal, authority or person, of that decision, conduct or failure. 90 This section provides the Court with a discretion to refuse relief. The Court considers that it should decline to grant relief in respect of its finding relating to the second decision because of the availability of an adequate alternative means of review. Section 60 provides for review by the Minister of a decision to cancel registration. On 28 September 2012 Phytologic made an application for review pursuant to s 60 of the TG Act. On 27 November 2012, the 60 day period for the Minister to advise of her decision elapsed. Phytologic's rights of review under the TG Act have now been spent and it would be moot to remit the second decision to the delegate for reconsideration according to law. 91 Because Phytologic has not proved error in the making of the first decision and because the Court has decided to not grant relief in respect of the second decision, the application must be dismissed. I certify that the preceding ninety-one (91) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Cowdroy.

Fishing Legislation Amendment Act 1984(Cth)

Therapeutic Goods Act 1989(Cth)ss 4, 19B, 19D, 26A, 30, 30A, 60

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Judgment (24 paragraphs)

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Legislation Cited (10)

Cases Cited (11)

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