Visvis and Secretary, Department of Health and Aged Care

[2025] ARTA 1582

Visvis and Secretary, Department of Health and Aged Care [2025] ARTA 1582 (20 August 2025)

DECISION AND REASONS FOR DECISION

Applicant:  Louis Visvis

Respondent:  Secretary, Department of Health and Aged Care

Tribunal Number:  2024/0733

Tribunal:  Deputy President K McMillan KC

Date:  20 August 2025

Place:  Brisbane

Decision:  The Tribunal affirms the decision under review.

…………..…[SGD]…….…….… Deputy President K McMillan KC

CATCHWORDS

Pharmaceutical Benefits – approved premises – decision under s 93(a) of the National Health Act 1953 (Cth) to cancel an approval to supply pharmaceutical benefits at approved premises – cancellation of the Applicant’s registration as a pharmacist under s 149C(1)(b) of the Health Practitioner Regulation National Law (NSW) (National Law) – whether the discretion in s 98(3) of the Act is enlivened and whether it should be exercised – “approved pharmacist”

LEGISLATION

Health Practitioner Regulation National Law (NSW)

National Health Act 1953 (Cth)

National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017

CASES

Australian Education Union v General Manager, Fair Work Australia (2012) 246 CLR 117

Coleman v Power (2004) 220 CLR 1

Flaherty v Secretary Department of Health and Ageing [2010] FCA 63 Holzberger v Secretary Department of Health & Ageing [2007] FCAFC 68 Koutsouroupas v Minister for Health [2024] FCA 677

Lloyd’s Underwriters v Cross (2012) 248 CLR 378, [25].

Northern Territory v Collins (2008) 235 CLR 619

Project Blue Sky Inc v Australian Broadcasting Authority (1998) 194 CLR 355 Shaffer v Secretary, Department of Health and Aged Care (2002) 124 FCR 234 Visvis and Secretary, Department of Health and Aged Care [2024] AATA 3159

Yu v Minister for Health (No 2) (2013) 216 FCR 188

SECONDARY MATERIAL

Deactivation of an approved pharmacist – Guidelines, November 2019

Explanatory Memorandum to the Health and Ageing Legislation Amendment Bill 2003 (Commonwealth)

Pharmacy Board of Australia, Guidelines for Proprietor Pharmacists (2015

Pharmaceutical Society of Australia Ethics for Pharmacists (2011)

Background

1.Mr Louis Visvis (the Applicant) seeks review of a decision of a delegate of the respondent (the Secretary) dated 4 January 2024 pursuant to s 93(a) of the National Health Act 1953 (Cth) (the Act) to cancel his approval to supply pharmaceutical benefits at approved premises being Terry White Kogarah Pharmacy located at Shop 1 Kogarah Town Centre, Kogarah (the Pharmacy).

2.The Applicant was registered as a pharmacist in 1991 and has owned the Pharmacy since 2000. From 2012 to 2017 the Applicant also owned Terry White Chemist Merrylands.

3.On 13 January 2009, the Applicant was approved under s 90(1) of the Act to supply pharmaceutical benefits at the approved premises, being the Pharmacy.1

4.The Pharmacy Regulation Unit Pharmacy Council of New South Wales commenced an investigation into allegations that during the period January 2014 to July 2016, the Applicant failed as the proprietor pharmacist to have oversight of the Pharmacy and to supervise his employee pharmacists to ensure they were compliant with New South Wales laws governing the dispensing and supply of various medications. These failures led to the dispensing, (on occasion by the Applicant himself), of over 50 forged prescriptions for Schedule 8 opioid medications mostly in the highest available strength, the supply of Schedule 8 and 4D medications at intervals exceeding the prescribed dose, a shortfall of almost 35,000 5mg tablets of diazepam and a number of unaccounted Schedule 8 drugs.2

5.The New South Wales Health Care Complaints Commission subsequently brought disciplinary proceedings against the Applicant in the Occupational Division of the New South Wales Civil and Administrative Tribunal (NCAT). On 31 July 2020, the NCAT cancelled the Applicant’s registration as a pharmacist under s 149C(1)(b) of the Health Practitioner Regulation National Law (NSW) (National Law) with a non-review period of 2 years. Among other things, NCAT found that:

(a)the Applicant engaged in unsatisfactory professional conduct in:

(i)failing to exercise appropriate professional judgment and acting improperly and grossly unethically in his dispensing of Schedule 4, 4D and 8 medications3; and

1 T-Documents (T) T2/11.

2 T 33 NCAT decision p 33.

3 T4/41-44 [43]-[59].

(ii)failing to account for 34,993 Diazepam 5mg tablets received at the approved premises between 31 May 2014 and 1 January 2016.4

(b)the gravity and repetition of the Applicant’s unsatisfactory professional conduct taken together amounted to professional misconduct5; and

(c)the Applicant’s claims that his conduct was the product of “naivete, delegation and distraction” were “at best woefully inadequate and at worst disingenuous,” such that the NCAT had “grave doubts” as to the Applicant’s candour and concern for “the trustworthiness and professional integrity of the [Applicant] in the longer term6.

6.The Applicant did not notify the Department of Health and Aged Care (Department), at any time, of the regulatory actions of the NCAT.

7.On 15 January 2021 the Applicant applied to the Pharmacy Council to transfer ownership of the Pharmacy from the Applicant to his brother, James Visvis (James).

8.On 29 January 2021, Ms Maria Watts of the Pharmacy Council was assigned to assess the application to transfer ownership of the Pharmacy to James.

9.On 8 March 2021, James applied to the Department for approval for a change of ownership of an approved premises (not involving a relocation) (James PBS Application).

10.On 11 May 2023, the Department served a notice of intention to reject the James PBS Application.

11.On 28 May 2023, James responded to the notice of intention to reject the James PBS Application.

12.On 12 September 2023, the Department served a further notice of intention to reject the James PBS Application.

13.On 25 September 2023, James responded to the further notice of intention to reject the James PBS Application.

4 T4/44-48 [60]-[77].

5 T4/48-50 [78]-[82].
6 T4/51-52 [91]-[93].

14.On 4 October 2023, the Department served a notice of intention to cancel the Applicant’s approval under s 98(3) of the Act to supply pharmaceutical benefits at the approved premises, being the Pharmacy.

15.On 17 October 2023, the Department rejected the James PBS Application.

Cancellation of the Applicant’s approval under s 98(3) of the Act

16.On 4 January 2024, a delegate of the Secretary exercised their discretion to cancel the Applicant’s approval under 98(3) of the Act to supply pharmaceutical benefits at approved premises, being the Pharmacy (the Cancellation Decision). The delegate found that the Applicant was not carrying on business at the approved premises (the Pharmacy), as a ‘pharmacist’ as the term is defined in s 4 of the Act.

17.The Cancellation Decision made on 4 January 2024 came into effect at 5:00pm AEDT on 14 February 2024.

18.On Monday 5 February 2024, the Applicant commenced these proceedings.

19.On 6 February 2024, the Applicant applied to the Administrative Appeals Tribunal (AAT) for an extension of time to seek review of the Cancellation Decision.

20.On 14 February 2024, the Cancellation Decision took effect. The Applicant requested that the AAT make an order staying the operation of the Cancellation Decision.

21.On 15 February 2024, the Pharmacy Council approved the Applicant’s application to change ownership of the approved premises.

22.On 19 February 2024, James made a further application for PBS Approval (the Second James PBS Application).

23.On 23 February 2024, the Second James PBS Application was rejected because Louis' PBS Approval was cancelled.

24.On 29 April, the AAT made orders:

a.   extending the time for making the application for review; and

b.   that the operation of the delegate’s decision be stayed until the decision of the Tribunal on the application for review comes into operation or until further order, subject to the following condition:

The application will not take any steps, or do anything under the present order, or otherwise act contrary to the orders made by NCAT on 3 July 2020 other than seek to transfer the pharmacy at Kogarah to his brother.

25.By decision dated 2 September 2024, the AAT revoked the previous decision to grant a stay on the basis that the Applicant had:

a.     acted “plainly in breach of the cancellation decision (when it was in effect) and the conditions of the stay order. Overall, the evidence shows that the Applicant has facilitated the supply of at least 15, 000 pharmaceutical benefits since the cancellation decision came into effect, in circumstances where has had no lawful authority to do so:” and

b.     “plainly acted in contempt of decisions of the Department and of [the] Tribunal” and failed to proffer “any evidence or submissions that he will now comply with the conditions attached to the stay order and cease trading.”7

26.The Applicant has not sought re-registration as a pharmacist since the decision of NCAT.

27.Counsel for the Applicant submitted that the sale of the business from the Applicant to James has been approved by the Pharmacy Council but not finalised pending the outcome from these proceedings.8 As the Tribunal understands, from Counsel for the Respondent, the outcome sought by the Applicant is commercially beneficial for him and allows for a transfer from the Applicant to his brother, rather than the more onerous procedure of James applying for a new approval from the Department of Health pursuant to s90(3)(a).9

The hearing

28.At the hearing the Applicant relied upon:

a.Statement and attachments of the Applicant sworn 21 November 2024;

b.Statement of James Visvis sworn 19 November 2024;

c.Statement of Rejwana Marjan sworn 19 November 2024;

d.Statement and attachments of Daisy Cheung sworn 22 November 2024.

29.Each of those deponents were required for cross-examination.

7Visvis and Secretary, Department of Health and Aged Care [2024] AATA 3159 at [16]-[17].

8 T15 L 16-20.

9 T21 L 18-20.

30.Mr Taverniti, solicitor, was the sole deponent called by the Secretary. His statement attached various documents relevant to the discretionary aspects of the application.

ISSUES FOR DETERMINATION

31.The central issue for the Tribunal’s resolution is whether the Applicant’s approval to supply pharmaceutical benefits from the pharmacy should be cancelled under s 98(3) of the Act, which is in the following terms:

(3)If the Secretary is satisfied that:

(a)an approved pharmacist is not carrying on business as a pharmacist at premises in respect of which the pharmacist is approved; or

(b)the premises are not accessible by members of the public for the purpose of receiving pharmaceutical benefits at times that, in the opinion of the Secretary, are reasonable;

then the Secretary may (at his or her discretion), by notice in writing to the pharmacist, cancel the approval of the pharmacist under section 90.

32.The Tribunal necessarily must consider:

a.whether the discretion in s 98(3) of the Act is enlivened by reason of the satisfaction of paragraph 98(3)(a); and

b.if yes, whether the Tribunal considering the matter afresh should exercise the discretion to cancel the approval.

Has the discretion to cancel been enlivened?

33.Section 98(3)(a) of the Act raises the question of who is the “approved pharmacist” and whether they are “carrying on business as a pharmacist” at the approved premises.

34.At the time of the cancellation decision (and until it came into effect), the Applicant was an “approved pharmacist” within the meaning of that term as defined in s 84(1) of the Act on the basis of the approval he was granted on 13 January 2009 (the PBS approval).

35.Since 31 July 2020 the Applicant has not been a registered pharmacist, nor has he sought to be as defined in s 4(1) of the Act because he has not been “registered as a pharmacist … under a law of a State or Territory law providing for the registration of pharmacists” – the relevant law being the National Law.

36.The Applicant contends that at the time of the approval of the PBS, he was a registered pharmacist and that it is irrelevant that he is no longer registered, as the Act allows a “class” of supplier of pharmaceutical benefits who is not a pharmacist.10

37.As against that, the Secretary, in essence, contends section 98(3)(a) of the Act envisages a more limited scope of an "approved pharmacist" who is carrying on business as a registered pharmacist at the approved premises (emphasis added). At the time of the cancellation decision (and until it came into effect), the Applicant was an "approved pharmacist" within the meaning of that term as defined in s 84(I) of the Act on the basis of the approval he was granted on 13 January 2009.

38.However, since 31 July 2020 the Applicant has not been a "pharmacist" as defined in s 4(I) of the Act, nor did he seek to be re-registered as a "pharmacist" as defined in s 4(I) of the Act because he has not been "registered as a pharmacist... under a law of a State or Territory law providing for the registration of pharmacists" - the relevant law being the National Law. As such, irrespective of whether the Applicant has carried on business at the pharmacy since the cancellation of his registration, it cannot have been as a "pharmacist" as the Act defines that term.

The legislation

39.In the recent decision of Koutsouroupas v Minister for Health 11 , Kennett J was considering the question of the validity of amendments that were made to the National Health (Pharmaceutical Benefits) (Conditions of Approval for Approved Pharmacists) Determination 2017 (Cth) by the National Health Legislation Amendment (Conditions of Approval for Approved Pharmacists) Instrument 2023 (Cth) (PB17 of 2023). While that decision is factually distinguishable from the current situation, His Honour detailed the scheme of the relevant Parts of the Act and considered the objectives of the Act and the determinations made pursuant to it. The Tribunal respectfully adopts the analysis set out in paragraphs [2] to [42] which are extracted in Appendix A to this decision.

40.Further to consideration of the above, s 92A of the Act provides that approval of a pharmacist is subject to conditions and s92A(1A) the Minister may “by legislative instrument, determine conditions”. Failure to abide by such conditions is deemed to be

10 T19 L35.

11 [2024] FCA 677.

an abuse of that approval. An abuse of that power is, as Kennett J pointed to, central to the Minister’s power to suspend or revoke the approval of a pharmacist.12

41.The current National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 201713 (PB 70 of 2017) relevantly provides:

Part 2 – Conditions

6 Standards of practice

An approved pharmacist must, in dispensing and supplying pharmaceutical benefits

a)   comply with all legal requirements for the practice of pharmacy;

…

c)    comply with the Code of Ethics for Pharmacists (2017) published by the Pharmaceutical Society of Australia;

d)     comply with Professional Standards – Version 5 -June 2017 published by the Pharmaceutical Society of Australia in June 2017, in relation to each patient;

e)   maintain a disciplined dispensing procedure.

8 Ensuring other pharmacists at approved premises comply with conditions … An approved pharmacist that is approved in respect of particular premises must ensure that a registered pharmacist:

a)who is not an approved pharmacist in respect of those premises ;and

b)          who dispenses pharmaceutical benefits at those premises; complies with the conditions set out in this determination.

The Applicant’s case

42.In support of their argument reference was made to the Explanatory Memorandum to the Health and Ageing Legislation Amendment Bill 2003 (Commonwealth) in relation to the insertion of section 98(3) which conferred a discretion upon the decision maker whether or not to cancel the relevant approval of a pharmacist who was no longer carrying on business as a pharmacist. Relevantly the Secretary may decide not to cancel an approval where an approved pharmacy has ceased to trade temporarily through illness or other anticipated circumstances.

43.It is not in dispute between the parties, that the legislative intent was to confer discretion not to cancel an approval. In the decision of Flaherty v Secretary Department of Health and Ageing14 , Moore J outlined the practical operation of the statutory scheme granting approvals and that the essential approval was to supply pharmaceutical benefits from particular premises. Approval is required to establish new pharmacy, to relocate an

12 Ibid 13.

13 PB70 of 2017 complied on 1 April 2024 and registered on 29 July 2024.

14 2010 FCA 63 [6-9].

existing pharmacy, to change ownership, expand or contract an existing pharmacy or temporarily close a pharmacy.

44.in Flaherty, Moore J summarised the role of the decision maker:

What the decision maker must do is evaluate whether, in the circumstances, the approval should be cancelled or not. I do not doubt that the decision maker must bear in mind that the purpose of the legislative scheme as it concerns pharmacists which involves this process of approval has as its overarching purpose to ensure that members of any particular community in Australia have access to pharmaceutical benefits through a pharmacist operating in that community though probably subject to issues of practicability. This matter where the pharmaceutical benefits will continue to be available to a given community is almost certainly a relevant consideration implied, but not expressed in the NH act which the decision maker would be bound to take into account when considering whether to cancel an approval.”15

45.The Applicant placed heavy reliance on the decision of the Full Court of the Federal Court of Australia in Holzberger v Secretary Department of Health & Ageing 16 (Holzberger), which considered the expression "carrying on business as a pharmacist", as the supply of pharmaceutical benefits, which has the meaning attributed to it by virtue of s 84 of the Act, being a drug or medical preparation.17

46.The Applicant contends the Court in Holzberger rejected the notion that the business of a pharmacist is 'the business of providing pharmaceutical benefits to those entitled to receive them' and the following passage of that judgment was emphasised by the Applicant18:

The Act uses the expression 'business as a pharmacist' in connection with businesses carried on by registered pharmacists, but the expression 'a business for the supply of pharmaceutical benefits' in subs 90(6) to describe the business of a non-qualified pharmacist. Similarly in subs 98(5) the Act refers to a person who is an approved pharmacist pursuant to subs 90(6) 'carrying on a business for the supply of pharmaceutical benefits'. It may have been thought inappropriate to describe a non-pharmacist as carrying on business as a pharmacist. Whatever the reason, the Act appears to distinguish between the two types of business. It would, we consider; be inappropriate in those circumstances to read the expression 'carrying on business as a pharmacist' as meaning 'carrying on a business for the supply of pharmaceutical benefits' or; using the wording adopted by the Tribunal in para 47 of its reasons, carrying on 'the business of providing pharmaceutical benefits to those entitled to receive them.

47.By reason of that decision, the Applicant concludes that the legislation is inclusive of non- pharmacists (that being an accredited pharmacist pursuant to the National Law) can be

¹⁵ [51].

¹⁶ [2007] FCAFC 68.

17 The Full Court referred to other statutory provisions to support that meaning See ss90(2), 90(3), 90(3AB) and 90(4).

¹⁸ At [51].

an ”approved pharmacist” for the purposes of the Act. It is submitted that there is nothing to prevent a person who is not registered as a pharmacist owning a business.

The Respondent’ s case

48.The Respondent commences with the more fundamental issue of whether the Applicant is “carrying on a business”.19 The case run by the Applicant is has he has not practised as a pharmacist since July 202020 or “had any involvement in the day operations and management of the business”21 and he relies upon the ownership of the pharmacy as illustrative of his carrying on business.22 On one view he has not personally supplied pharmaceutical benefits then, by virtue of s 98(6) by definition he is not carrying on a business.

49.If it is the case that the Applicant, as the sole ‘approved pharmacist’ at the approved premises, has been carrying on the business, the Respondent rejects the notion that support can be found in Holzberger.23 The approval which was at issue in Holzberger can be distinguished as it related to a person who was a registered pharmacist.24

50.On appeal on a question of law from the AAT’s decision to cancel Ms Holzberger’s approval under s 98(3) of the Act, the Full Court was asked to answer the specific question, among others:

Was it a relevant consideration, in construing the meaning of the phrase ‘carrying on business as a pharmacist’ in s 98(3) of the [Act], that the word ‘pharmacist’ is expressly defined for the purposes of the [Act] by s. 4 of that Act:25

51.It was in that context that the Full Court stated in considering the meaning of the expression ‘carrying on business as a pharmacist’:

The expression ‘carrying on business as a pharmacist’ (the “expression”) is not defined in the Act, although the word “pharmacist” is defined by reference to the registration provisions of state and territory legislation. The meaning of the expression might be established by reference to such legislation, but it is at least theoretically possible that such an approach would lead to there being different effective definitions in different states and territories. Likely that the expression uses the word pharmacist in a generic sense the shorter Oxford dictionary defines that word to mean a person who prepares or dispenses medication medicines for present purposes it is likely that such a business would include the supply of pharmaceutical benefits to the Act.

19 RSFIC [21].

20 T33.
21 Applicant’s statement 21/11/24 at [33].

22 SFIC [35].
23RSFIC 22.

24 Holzberger at [1].

25 Holzberger at [4]

52.Finally, it is said that cases are only authoritative for what they decide Coleman v Power26 and that the Court in Holzberger was not asked to decide this question being a very different one as to when section 98(3)(a) is capable of satisfaction where the approved pharmacist involved is not registered to be a pharmacist at all.

53.With the cancellation of the Applicant’s registration, the Secretary contends Parliament did not intend the relevant section to be enlivened, particularly when a person has ceased to practice because of misconduct.27

Consideration of s 98 (3)

54.

29

 

The task of statutory construction is to give the words of a statutory provision the meaning that the legislature is taken to have intended them to have.28 Contemporary principles of statutory construction emphasise the primacy of statutory text, context and

purpose.

55.Ultimately “the fundamental duty of the Court is to give meaning to the legislative command according to the terms in which it has been expressed”. 30 The task of statutory construction is informed by considering which meaning is most consistent with the language of the statute as a whole, and with the purpose of the statute as a whole.31

56.As the Respondent points out there are two alternative interpretations available as to whether the Applicant falls within s 98(3)(a) of the Act. Consistently with his oral evidence, the Applicant has not worked as a pharmacist since July 2020, but has authorised others to supply pharmaceutical benefits from the approved premises 32 , aware that he could not lawfully supply those benefits himself.33 No other pharmacist had or has the relevant PBS approval to operate as an approved pharmacist at the premises and scripts were being filled before and after the operative date of the cancellation of that approval.

26 (2004) 220 CLR 1 at [79].

27 RSFIC 24-25.

28 Project Blue Sky Inc v Australian Broadcasting Authority (1998) 194 CLR 355, [78]; Lloyd’s Underwriters v Cross (2012) 248 CLR 378, [25].

29 Australian Education Union v General Manager, Fair Work Australia (2012) 246 CLR 117, [27].
30Northern Territory v Collins (2008) 235 CLR 619, [16].
31 Lloyd’s Underwriters, [24].

32 T36 L 19-20.

33 T37 L 14-16.

57.If that evidence is accepted, he was not supplying pharmaceutical benefits and merely relies on his ownership of the pharmacy, then pursuant to s98(6) he is taken not to be carrying on business as a pharmacist (emphasis added). That being the case, the discretion pursuant to s 98(3)(a) is enlivened and the argument advanced relying on the reasoning in Holzberger does not arise.

58.If ownership of the business and being the only holder of the relevant approval deems the Applicant to be “carrying on a business” or if he is more actively involved in the business than his oral evidence indicates, the Applicant’s reliance on a selective passage cited from the Holzberger reasons is misplaced. The Tribunal concludes that passage is not of broader application permitting non-pharmacists to carry on such a business. The Full Court was answering a question of narrower import and the pharmacist in that case was registered. While that section was amended not long after Holzberger, that is not relevant here. The Applicant does not point to any authorities which have considered this point further; rather they have centred upon the supply of pharmaceutical products from approved premises.

59.In considering the construction of “approved pharmacist” the following passage per Jessup J is instructive. In Yu v Minister for Health (No 2)34 (Yu) (emphasis added):

… approvals under s 90 or s 90A are not given as benefits or emoluments to particular pharmacists. Rather, the scheme of the NH Act, relevantly, is to ensure that the community is provided with convenient access to pharmacies, conducted by appropriately qualified professionals, for the purpose of obtaining drugs and medicinal preparations which are beneficial in the treatment of sickness or disease but which may, at the same time, be harmful if not properly prescribed and dispensed.

60.This is consistent with the Determination PB 70 of 2017, which gives statutory force to the relevant conditions upon an approved pharmacist and as set out above, specifically refers to the professional standards as an owner and pharmacist.

61.The language of the operative Guidelines for Pharmacists published by the National Board was cited in the relevant NCAT decision:

(1)      Proprietors to maintain an active interest in how the pharmacy business is conducted

If the proprietor/owner or partner-in-ownership pharmacist is not the pharmacist usually in charge of that pharmacy, he or she must vigilantly maintain an active interest in how the practice of pharmacy is being conducted. ……

(2)      Proprietor pharmacists cannot delegate their professional obligations

34 (2013) 216 FCR 188 at [10].

A proprietor/owner or partner-in-ownership of a pharmacy cannot delegate his or her professional obligations, even if that partner is not regularly present at the pharmacy. This applies to pharmacists who own a pharmacy, or pharmacies, in all forms of business structures.”35

62.In the expert evidence before NCAT, reference was made to Pharmaceutical Society of Australia Ethics for Pharmacists (2011), (in force at the relevant time) which states:

Professional judgment must be exercised to prevent the supply of products likely to constitute an unacceptable hazard to health or the supply of unnecessary and/or excessive quantities of medicines or products, particularly those which had a potential for abuse or dependency.36

63.The circumstances which formed the bases for the findings of unprofessional conduct and misconduct underline the hazards identified, being the 35,000 unaccounted diazepam tablets and the dispensing of forged scripts for Schedule 8 drugs and opioid medication, being two examples of these hazards.

64.Given the express legislative and professional provisions referred to and analysed above, they are inimical to the reasoning advanced by the Applicant. They are specific to that pharmacist and are of a continuing nature. To do as the Applicant suggests, taken to its logical conclusion, this would allow a person who has not been registered or has their registration cancelled, to be able to carry on such a business. 37

How the discretion to cancel should be exercised

65.The Respondent submits that the Applicant’s entire purpose in seeking to have the cancellation decision set aside is at odds with the statutory scheme. The scheme does not exist to provide a person, whose registration to practise as a pharmacist has been cancelled, with a commercially valuable statutory right with which to deal for personal profit, and certainly not when that person has concealed a material change of circumstances from the Department. The Tribunal accepts that submission.

66.Having found that the discretion is enlivened, the Tribunal must then consider whether to exercise it. As the Respondent contends, it is not in dispute that the fact of the former cannot dictate the outcome of the latter: Shaffer v Secretary, Department of Health and Aged Care (2002) 124 FCR 234. The Respondent submits that cancellation is the only outcome in this case that would uphold the scheme for approval to supply

35 Paragraph 23.

36 Paragraph 24.

37 T19 L35.

pharmaceutical benefits under the Act, having regard to the conduct of the Applicant who has treated that scheme with contempt.

67.The Applicant contends that the discretion ought not be exercised for the following reasons:

a)the decision maker erroneously took into account the rejection of the application of James for a relevant PBS approval, which was caused by the delay in the Council’s approval of transfer;

b)    that if James were to apply for a new approval, it would be unlikely to succeed;

c)the deleterious consequences for the pharmacy’s employees and patients, the latter raising the ground of public interest.38

68.The complaint as to the delegate taking into account effectively an irrelevant factor can be disposed of shortly. The Tribunal is to make the correct and preferable decision.

69.The lengthy delay by the Pharmacy Council in approving the transfer undoubtedly aggrieves the Applicant.

70.The Applicant complains that the delegate has been unreasonable in not deferring the decision in relation to the PBF approval until the Pharmacy Council decided the transfer application, in circumstances where the delegate was aware that the application was being considered by the Pharmacy Council.

71.He also complains that James is unlikely to secure the Pharmacy Council approval and that should not militate against him.

72.In the final analysis, whilst there is some force in his complaints as to delay by the Pharmacy Council, there is no remedy within the Tribunal’s jurisdiction.

73.As to the likelihood of securing the relevant Pharmacy Council approval, it should be borne in mind that the Applicant’s main objective is to secure a transfer of the Pharmacy as a going concern, given he is not registered as a pharmacist. He expects to receive in the region of $1million dollars profit from the sale to his brother James. Also, if the decision of the delegate is set aside, it is expected that the Applicant will retrospectively claim the PBF benefits. The respondent correctly submits that this legislative scheme

38 ASFIC.

does not exist to provide a person whose registration has been cancelled with a commercially valuable statutory right with which to deal for personal profit and not when that person has concealed a material change of circumstances from the delegate.

Conduct prior to cancellation

74.As a result of the investigation undertaken by the Pharmacy Board, conditions were placed on the Applicant’s registration leading up to the cancellation of his registration in 2020. Given the findings above the Applicant was not an “approved pharmacist“ after July 2020 and was not able to supply pharmaceutical benefits. Nor can an approval that was given under s 90 to a person who is no longer a “pharmacist” permit that person to authorise other pharmacists, who have not themselves been approved under s 90(1) for the premises, to supply pharmaceutical benefits at or from the premises.

75.The Applicant took no step to advise the Department of Health of his cancellation of his registration in a period exceeding 3 years, his oral evidence being that he presumed that as the Australian Health Practitioners Regulatory Authority was aware then it would follow that the Secretary would also have that knowledge. It is irreconcilable with the obligations of his profession that he would not make any attempt to do so.

76.Despite the imposition of conditions and more pertinently the cancellation of his registration no steps were taken to deactivate his approval, a step which may have been taken to facilitate the transfer and avoiding the continuation of the operation of the pharmacy where the approved provider was unable to practice.39

77.Nor on the Applicant’s evidence, did any other pharmacist seek approval pursuant to s 90 to supply pharmaceutical benefits.40

78.As the Respondent submits, the Applicant’s concerns of the adverse consequences for the staff and patients of the Pharmacy, should the cancellation of his approval stand, nonetheless did not cause him to take any step to mitigate that harm.

79.It is also of note that the pharmacy manager Ms Cheung herself did not undertake any action to regularise the position given:

39 RSFIC par 34 See Department of Health and Aged Care, Deactivation of an approved pharmacist – guidelines, November 2019: approvedppharmacist-guidelines.

40 Affidavit of Aaron Francis Taverniti dated 3 July 2024 at [8].

a.her responsibility to “ensure that the pharmacy and the staff comply with all relevant State, Federal and Pharmacy based policy, legislation and professional procedures (such as the QCPP and Occupational Health and Safety);”

b.she had herself been subject to conditions placed on her registration between 2016-2018; and

c.lectures in ethical obligations and professional conduct at under and post-graduate level.41

Conduct since the cancellation decision

80.The cancellation of the approval on 4 January came into effect on 14 February 2024. While the Applicant’s oral evidence was opaque as to when he became aware of it, he promptly gave instructions to seek a stay of the decision and he was aware that he could not supply pharmaceutical benefits from that date.42

81.Having successfully been granted a stay, the condition of it was clear that the Applicant, “will not take any steps, or do anything under the present order, or otherwise act contrary to the orders made by NCAT on 3 July 2020, other than seek to transfer the pharmacy at Kogarah to his brother”.43

82.The documentary evidence demonstrates that pharmaceutical benefits were continued to be supplied to patients on the purported authority of that approval on each day from 14 February 2024, when the cancellation decision came into effect, up to and including 25 November 202444 (except for 29 and 31 March 2024, which were public holidays in NSW), in excess of 15,000 pharmaceutical benefits.45

83.The Applicant also took no adequate steps to inform the manger and staff of the cancellation of his registration, the PBF approval, the stay and its conditions nor the revocation of the stay.46

84.The witnesses Ms Cheung and Ms Marjaran gave evidence that they became aware of the cancellation by a “red sign” appearing on the computer screen indicative of the

41 A6 paragraphs 3-9.

42 T39 l 44, T 44.

43 G2.
44 R4 , R7.

45 G2.

46 T 45.

cancellation of the PBF Approval. Ms Cheun and Ms Marjaran advised the Applicant of this occurring. The latter relied upon Ms Cheung to record and act upon those screens.

85.Whilst Ms Cheung deposed to efforts being made to “ensure the safest and most compliant pharmacy“, she took no action following the cancellation, the stay and its subsequent revocation.47 She was also unaware of the fate of PBS rebate claims made after the Cancellation Decision when she teaches on that topic - including the regulation and registration of pharmacists. 48 No documents were produced in answer to a summons addressed to her, nor did she seek clarification of its contents and accepted she was “careless about legal obligations”.49

86.In essence, as the Tribunal found in its revocation of the stay, the Applicant was aware of the ongoing dispensing of PBS scripts despite the cancellation of the approval. This is supported by the oral evidence of Mr James Visvis, that he had minimal involvement with the business and the Applicant was funding the shortfall between the payment by a customer and the cost of the script.

87.When it decided to revoke the stay of the cancellation decision, not only was the continued supply plainly in breach of the Cancellation Decision, it was also in breach of the condition of the stay order. There were desultory at best efforts made by the Applicant and Ms Cheung, as the manager, to have the Pharmacy abide by the cancellation Decision or the stay decisions made in 2024.

Continued access to pharmaceutical benefits by the community: public interest

88.As outlined earlier in these reasons, the legislative scheme relating to the approval of a pharmacy emphasises the community having access at appropriate access to the dispensing of pharmaceutical benefits. The Applicant and his witnesses concede that in and around the Pharmacy there are approximately 8 other pharmacies.

89.Ms Cheung and Ms Maharjan both identify in their statements particular factors pertaining to the Pharmacy which make it unique including the following:

·the Pharmacy has served the community for 50 years and is the oldest pharmacy in the area and has wide demographic catering for elderly as well as young adults and families with young children

47 T 62, T 71.

48 T67.

49 T69.

·it provides services for prescriptions classified as schedule 4 and schedule 8 drugs

·it also accommodates all types of concession cards including pensioners and repatriation. Apparently the vast majority of the prescriptions dispensed are PBS subsidised

·the 8 other pharmacies within one kilometre radius do not compare favourably due to a number of factors including - greater opening hours and is adjacent to a train station assisting accessibility

·the range of services offered by the pharmacy, that prioritises health service delivery over profit and include offerings such as vaccination services diabetes services scheme cholesterol checks and many others. The number and quality of these services are apparently unmatched by any other pharmacy in the Kogarah region and are unique to the pharmacy

·Its’ services have the objective of alleviating the burden on general practitioners and reduce wait times for patient

·that during the COVID-19 pandemic it was the first pharmacy within the area to receive the vaccine

·The impact of closure on long serving employees.

90.During cross-examination, a number of these claims did not bear scrutiny – relying on community feedback, an annual phone call or a review of other pharmacies website.50 Some were of an extravagant nature, for example that the due to the cancellation of the approval “life saving medications” could not be supplied to patients, only to concede that customers attending other pharmacies upon presentation of them could gain access to them at other pharmacies.51

91.The Tribunal did not find either witness to be reliable, despite deposing as to how the pharmacy was compliant and achieving “best practice under legislative and QCPP guidelines” when scant if any attempts were made to understand or comply with the cancellation of the PBF approvals. Both displayed a cavalier attitude to compliance with summonses issued by the Tribunal. It was argued that they were lay witnesses and that ought to be taken into account. The Tribunal does not accept that. They are professionals but made no attempt to comply with the summonses. While the Pharmacy has existed for many years and provides services for the community in Kogarah, the claims as to the unique nature of the Pharmacy, the Tribunal finds, are not based on solid foundation.

50 T 112.

51 T 111.

Conclusion

92.The Tribunal accepts the Applicant’s conduct leading up to and after the cancellation of his PBF approval in January promoted his personal interests and those of his family over his professional and legislative obligations. The scheme of the legislation is to promote proper access by the community to pharmaceutical benefits in a safe and regulated manner. The Secretary has a suite of powers to ensure that pharmacies comply with that scheme and the Applicant did not undertake the most basic step of informing the Department of his cancellation in 2020. The Applicant since 2020 as owner and as an “approved pharmacist“ has breached the conditions imposed by the Act and leading up to the cancellation militate against the exercise of discretion. Since the cancellation, the Tribunal has concluded that the conduct was in breach of the cancellation, the terms of the stay and the revocation of it in September 2024.

93.The Cancellation Decision should be affirmed.

Appendix A – extract from Koutsourapas v Minister for Health

1. Part VII of the Act provides for pharmaceutical benefits. Section 85(1) provides that “[b]enefits shall be provided by the Commonwealth, in accordance with this Part, in respect of pharmaceutical benefits”. “Pharmaceutical benefits” (defined in s 84) are, in substance, drugs in various forms. However, the “benefits” referred to in s 85 (to be provided “in respect of” pharmaceutical benefits) are forms of financial assistance.

   (a)Section 86 provides for a person who is an eligible person under the Health Insurance Act 1973 (Cth) to “receive pharmaceutical benefits under this Part without the payment or provision of money or other consideration other than a charge made in accordance with section 87”.

   (b)Section 87(1) provides that an approved pharmacist (or other practitioner) is not to demand or receive payment for provision of a pharmaceutical benefit, other than a payment from the Commonwealth, subject to the succeeding provisions of s 87. The other subsections of s 87 govern the amounts that may be charged from various categories of person.

   (c)Under s 89, a person is (with limited exceptions: see s 89A) “not entitled to receive a pharmaceutical benefit” unless it is supplied:

   by an approved pharmacist, at or from premises in respect of which the pharmacist is for the time being approved, on presentation of a prescription written by a PBS prescriber in accordance with this Act and the regulations, or, in such circumstances as are prescribed, on communication to that pharmacist, in the prescribed manner, of a prescription of a PBS prescriber

   (d)Division 3 of Part VII establishes a regime for the determination of prices for medications and for payments to approved pharmacists and approved medical practitioners. Section 99 confers on such a practitioner an entitlement to be paid, by the Commonwealth, the relevant amount determined for each pharmaceutical benefit supplied.

2. Generally, therefore, it is only an “approved pharmacist” who can supply a pharmaceutical benefit under the Act and receive payment from the Commonwealth in respect of the provision of that pharmaceutical benefit under s 99.

3. Section 90 provides for the approval of pharmacists by the Secretary. The relevant provisions of s 90 for present purposes are as follows.

   (1)Subject to this section, the Secretary may, upon application by a pharmacist for approval to supply pharmaceutical benefits at particular premises, approve that pharmacist for the purpose of supplying pharmaceutical benefits at those premises.

   …

   (2)Where a pharmacist desires to supply pharmaceutical benefits at more than 1 premises, a separate application under subsection (1) shall be made in respect of each of the premises and, where approval is granted in respect of 2 or more premises, a separate approval shall be granted in respect of each of the premises.

(3)Subject to this section, where an approved pharmacist desires to supply pharmaceutical benefits at premises other than premises in respect of which approval has been granted, the Secretary may on application by the approved pharmacist, grant approval in respect of those other premises.

…

(3A)Subject to subsections (3AA), (3AE) and (13), an application under this section must be referred to the Authority.

(3AA)Subsection (3A) does not apply to an application for an approval arising out of a change in the ownership of a pharmacy situated at particular premises if the change results or resulted from:

(a)the sale of the pharmacy; or

(b)the acquisition, following the death of a person who was the owner or one of the owners of the pharmacy, of that person’s interest in the business of the pharmacy; or

(c)          a change in the constitution of a partnership that owned the pharmacy; if the pharmacy is to continue to operate at the same premises.

…

(3AE)  Subsection (3A) does not apply to an application for an approval if:

(a)the application arises out of an expansion or contraction of particular premises (the original premises) at which a pharmacy is situated; and

(b)the expanded or contracted premises occupy any of the space occupied by the original premises.

…

(3B)An approval may be granted under this section in respect of an application that has been referred to the Authority under subsection (3A) or (3AF) only if the Authority has recommended the grant of the approval, but the Secretary may refuse to grant an approval even if the grant has been recommended by the Authority.

(3D)The Secretary must not grant approval under this section to a pharmacist in respect of particular premises if the Secretary is satisfied that on or after the day the approval would otherwise be granted:

(a)the pharmacist would be unable to supply pharmaceutical benefits at the premises; or

(b)the premises would not be accessible by members of the public for the purpose of receiving pharmaceutical benefits at times that, in the opinion of the Secretary, are reasonable.

(4)Nothing in this section authorizes the Secretary to grant approval to a pharmacist in respect of premises at which that pharmacist is not permitted, under the law of the State or Territory in which the premises are situated, to carry on business.

…

(5AA) If, under this section, a pharmacist is granted approval to supply pharmaceutical benefits at particular premises, the pharmacist may also supply pharmaceutical benefits from those premises.

…

(6)For the purposes of this section, a reference to a pharmacist is taken to include a reference to a person who owns, or is about to own, a business for the supply of pharmaceutical benefits at particular premises.”52

…

6         Four things will be observed at this point.

(a)Section 90 assumes the existence of State and Territory laws that govern practice as a pharmacist including the right to practise at particular premises (s 90(4)). This serves as a reminder that the Act regulates the availability of a Commonwealth subsidy, not the lawfulness of any particular things done or not done in the supply of medications. Correspondingly, “pharmacist” is defined in s 4 of the Act as a person registered as a pharmacist under a law of a State or Territory providing for such registration. Thus, the persons who may apply for approval, and become “approved”, for the provision of pharmaceutical benefits under the Act are a subset of the persons registered and permitted to practise as pharmacists under State and Territory law.

(b)Approval is sought and granted in respect of particular “premises” (s 90(1)-(3), (3D),

(4)). A pharmacist is not approved under s 90 in any general sense, but only for the purpose of supply at specified premises. Approval is not to be granted in respect of premises if pharmaceutical benefits cannot be supplied to members of the public “at” those premises (s 90(3D)) or if supply at those premises is not permitted under State or Territory law (s 90(4)).

(c)Except in cases where an application involves continued use of “premises” already approved (s 90(3AA), (3AE)), the application must be referred to “the Authority” (which is the Australian Community Pharmacy Authority established by s 99J). The Authority is to make recommendations to the Secretary. It must frame those recommendations in accordance with “rules” which the Minister must determine under s 99L……

…

42For some years an established feature of those rules53 and the Authority's recommendations has been that approval in respect of premises depends, in part, on where the premises are. This reflects an understanding that the geographical distribution of pharmacies, so as to make in-person pharmaceutical services and advice widely available, is an important factor to be considered in approval decisions. …… in Walkerden v Wodonga Pharmacy Pty Ltd [2015] FCA 273; 230 FCR 243 at [62], Mortimer J (as her Honour then was) described the objectives of the rules then in force under s 99L as follows.

“Those objectives have twin themes: a sustainable and viable community pharmacy network (which focuses at least as much on the interests of pharmacy owners as on the community) and access to pharmaceutical benefits (with a focus only on the community's interests). In that sense, the location rules are an attempt to balance community access with commercial sustainability.”

52 Paragraphs 2-6(a)

53 Koutsouroupas v Minister for Health and Aged Care [2024] FCA 677 at [42]