Hanna v Pharmacy Council of New South Wales

NCAT Occupational|2021-10-22|Before: Jennifer Boland AM

Introduction

Mr Tamar Hanna is a registered pharmacist. Following a hearing conducted by the Pharmacy Council of New South Wales (the Council) under s 150 of the Health Practitioner Regulation National Law (NSW) (the National Law) conditions were imposed on Mr Hanna's registration. The conditions came into effect when notified by the Council to Mr Hanna in a letter dated 13 October 2021.
On 14 October 2021 Mr Hanna filed an External Appeal form in the Tribunal. The appeal is agitated under both s 159 and s 159B of the National Law. On 14 October 2021 Mr Hanna also filed an application for a Stay.
Mr Hanna's appeal and his stay application were listed on an urgent basis for directions on 20 October 2021. On that day Mr Hanna's counsel made an oral application for an interim stay pending the hearing of the stay application .which has been fixed for hearing on 3 November 2021. Because the Council had been advised the matter was listed for directions only on 20 October 2021, I declined to hear the interim stay application that day and stood the oral application over until 9am on 22 October, 2021.
On 22 October 2021 both parties made short oral submissions. The Council opposed the interim stay. I granted leave to both parties to file and serve written submissions in respect of the interim stay on that day and indicated I would publish my orders either later on 22 October 2021 or, at the latest, on 25 October 2021 with reasons to follow.
The reasons which follow explain why I refused the interim stay.

Documents relied on in support of the interim stay

Mr Hanna has filed two affidavits in support of the stay application. His first affidavit is an affidavit of 15 October 2021 and his second affidavit was sworn on 21 October 2021.
Mr Hanna provided a signed undertaking annexed to his affidavit of 21 October 2021 in which he undertook until the hearing of the stay application on 3 November 2021 that: "1. I will not personally compound except for the purposes of a performance assessment; and 2. I will not personally engage in any way, whether as a proprietor-pharmacist or as an employed pharmacist, in the dispensing and supply of any prescribed medicines and/or scheduled medicines by way of Mail Order, E-mail, Internet or any other similar electronic method of delivery and receipt of prescriptions intended for dispensing and supply, without face-to-face contact with the patient for whom any medication is prescribed or face-to-face contact with a carer or agent, of any such patient."

Matters relied on in support of the stay

Mr Hanna submits an interim stay should be granted for a number of reasons. The reasons may be briefly summarised, in no particular order, as follows: 1. Mr Hanna was notified that the hearing under s 150 to be conducted on 13 September 2021 was to address three complaints notified to him in December 2019 and May 2021. However, on that day the matter was not complete and was stood over to 23 September 2021. On 22 September 2021 at 8.06pm his lawyers received further documents and he did not have sufficient time to review or answer the material provided. Thus, Mr Hanna submits he was denied procedural fairness. However, this submission was not pressed by Mr Hanna's counsel in his oral submissions when his attention was drawn to an email from the Council which disclosed the documents provided on 22 September 2021 were the documents relied on before the Council on 13 September 2021 together with replies filed by Mr Hanna. For completeness, I note that different lawyers represented Mr Hanna at the s 150 hearing to those presently representing him. 2. That no reasons for decision of the Council have been provided to him. He also asserts that there is no transcript of the hearing. However, I was advised by the Council's solicitor, Ms Kennedy, on 20 October 2021 that a transcript is presently being prepared. Again, Mr Hanna submits the lack of transcript and reasons for the decision causes procedural unfairness to him. 3. That the effect of the conditions as drafted require Mr Hanna to "stop any of his [my] pharmacies from providing compound products and from filling any scripts without face to face consultations". However, after seeking clarification from the Council it appears Mr Hanna now accepts that the restriction on dispensing scripts for prescribed medication (but not compounded products) applies to him and not to his employed pharmacists. Nor is he restrained from personally filling prescriptions (other than compounded medications) for patients who present in person to his pharmacies. 4. That the conditions as drafted are not proper conditions because they are not conditions restricting how he practises but rather restrict five pharmacies owned by corporate entities of which he is the director and sole shareholder from dispensing prescriptions and compounding medication. 5. That the effect of the conditions is that the supply of prescriptions through mail order cannot occur and this is detrimental to patients during the pandemic environment. 6. That certain compounds are made at the pharmacies which could have serious consequences for the patients if there are disruptions to treatment through lack of supply. 7. That certain pharmacies dispense to a number of nursing homes and the conditions imposed make such dispensing impractical. 8. The effect of the conditions is to impose a significant loss of revenue to the pharmacies. The "stand-alone" mail order business operated by one pharmacy known as Filled Pharmacy cannot operate at all under the conditions with the consequence that staff have been or will have to be stood down, rent of $180,000 per annum continues and there is a loss of revenue of approximately $2,554,000 per month from that pharmacy alone.

Proposed grounds of appeal on a question of law.

I accept that Mr Hanna may wish to file amended Grounds of Appeal on receipt of the Council's reasons.
Mr Hanna asserts that: 1. the Council has breached s 150B of the National Law by failing to record the meeting conducted under s 150; 2. he has suffered a denial of procedural fairness by reason of lack of transcript and reasons for decision; 3. the conditions imposed are beyond power in essence being conditions on the manner in which the pharmacies operate rather than the practise of a pharmacist in the course of his profession and are therefore ultra vires; 4. the council took into account irrelevant considerations; 5. the council had no evidence that conditions were required to protect the public; 6. the Council failed to take into account recent legislative changes regarding COVID 19; and 7. the Council's decision was so unreasonable that no reasonable person could have made the decision.
I discuss the principles relevant to the granting of a stay in Segal v Medical Council of New South Wales [2020] NSWCATOD 86. Those principles are equally applicable to an application for an interim stay. The relevant principles are discussed in [43]-[57] of Segal as follows: 43 It is undisputed that the Tribunal's only power under the National Law to grant a stay is pending the hearing of an appeal on a question of law under s 159B (see Medical Council of New South Wales v Lee [2017] NSWCA 282). The principles applicable to this stay application are subject of well- established authority. I repeat my summary of the authorities as set out Taylor v Medical Board of Australia [2018] NSWCATOD 50 at [10]-[11]. The relevant principles to be applied in determining a stay application in the context of a commercial dispute were set out in this Tribunal by Wright J in Bentran Pty Ltd v Sabbarton [2014] NSWCATAP 37. That decision refers to a number of authorities on the topic of stays including Alexander v Cambridge Credit Corporation Ltd (1985) 2 NSWLR 685. Additional considerations apply to matters which may affect the public (see NSW Bar Association v Stevens [2003] NSWCA 95 at [91] and Kirbach v Health Care Complaints Commission [2015] NSWCATAD 195). In this and in all matters under the National Law the Tribunal is required to apply the objective and guiding principle set out in s 3A. Section 3A provides as follows: 3A Objective and guiding principle [NSW] In the exercise of functions under a NSW provision, the protection of the health and safety of the public must be the paramount consideration. The general principles to be applied in considering whether to grant or refuse a stay are summarised by the Full Court of the Family Court in Aldridge v Keaton (Stay Appeal) [2009] FamCAFC 106. While the Full Court refers to the taking into account the best interests of a child in parenting proceedings as a paramount consideration, similarly in applications under the National Law third party interests (the health and safety of the public) are the paramount consideration. The Full Court explained at [18]: The principles to be applied in determining an application for a stay of orders both in the general law and in respect of parenting proceedings are also well known (see The Commissioner of Taxation of the Commonwealth of Australia v Myer Emporium Limited [No.1] [1986] HCA 13; (1986) 160 CLR 220 at 222; Alexander v Cambridge Credit Corporation (1985) 2 NSW LR 685; Jennings Construction Limited v Burgundy Royale Investments Pty Limited [1986] HCA 84; (1986) 161 CLR 681; Clemett & Clemett [1980] FamCA 90; (1981) FLC 91-013; JRN & KEN v IEG & BLG (1998) 72 ALJR 1329 at 1332). The authorities stress the discretionary nature of the application which should be determined on its merits. Principles relevant to this matter include the following: a person who has obtained a judgment is entitled to presume the judgment is correct; the mere filing of an appeal is insufficient to grant a stay; the onus to establish a proper basis for the stay is on the applicant for the stay. However it is not necessary for the applicant to demonstrate any "special" or "exceptional" circumstances; a person who has obtained a judgment is entitled to the benefit of that judgment; the bona fides of the applicant; a stay may be granted on terms that are fair to all parties - this may involve a court weighing the balance of convenience and the competing rights of the parties; a weighing of the risk that an appeal may be rendered nugatory if a stay is not granted - this will be a substantial factor in determining whether it will be appropriate to grant a stay; some preliminary assessment of the strength of the proposed appeal - whether the appellant has an arguable case; the desirability of limiting the frequency of any change in a child's living arrangements; the period of time in which the appeal can be heard and whether existing satisfactory arrangements may support the granting of the stay for a short period of time; and the best interests of the child the subject of the proceedings are a significant consideration. 44 Of particular relevance in this stay application are the principles espoused by Spigelmen CJ in New South Wales Bar Association v Stevens [2003] NSWCA 95 at [90]-[104] and at [106]. His Honour explained at [91]: The relevant authorities indicate that the protection of the public is a matter entitled to significant weight on an application for a stay once it appears that a professional person has acted improperly to a substantial degree. 45 Later, at [103]-[104] his Honour further referred to the importance of public interest considerations as follows: The significance of the public interest dimension in the exercise of the discretion to grant a stay in such circumstances, was highlighted by Kirby J in Bryant v Commonwealth Bank of Australia (1996) 70 ALJR 306 at 309 where his Honour said: "In the exercise of the jurisdiction to provide a stay, it has often been emphasised that cases involving a stay of the operation of the criminal law or of laws designed to protect the public (e.g. deregistration of a professional lawyer or medical practitioner) are in a class different from cases involving no more than the suspension of the operation of orders affecting two private litigants only." It is clear from this consideration of the authorities that each case must turn on its specific facts. The range of relevant considerations is broad. Nevertheless the fact that the issues involved in professional rights to practice concern the protection of the public, means that the public interest is always entitled to significant weight. 46. I also have regard to the decision of Legal Services Commissioner v Barker [2005] QCA 482 and in particular the discussion in that decision of a stay in the context of a legal practitioner where protection of the public is a relevant consideration. Other authorities in this Tribunal also stress the unique considerations to be taken into account in considering a stay involving a health professional (see Liu v Chinese Medicine Council of NSW [2019] NSWCATOD 13; Hill v Medical Council of NSW [2019] NSWCATOD 52). 47. As noted above, the appeal on a point of law and the stay application fall to be determined under the National Law. As with all applications under the National Law the object in s 3A is relevant, namely, that the health and safety of the public must be the paramount consideration. 48 Only two provisions of the National Law deal with stays pending an appeal. Those provisions are s161B and s 165L(2). 49 Section 161B provides as follows: 161B Appeal does not stay decision [NSW] An appeal under this Division does not operate to stay the effect of the decision being appealed against unless the Tribunal otherwise orders. 50 Section 161B is found in Sub-Division 3 of Division 6 of Part 8 of the National Law. The appeal rights dealt with in Division 6 are appeals against a decision of a Committee or a Council or appeals on a point of law from such a decision making body. 51 The second provision is s 165L(2). It provides as follows (1) … (2) The Tribunal may, in respect of an appeal under section 159B, make an order staying the decision of the Council appealed against until the appeal has been disposed of. … 55 The Council submits that s 165L(2) does not, on its face, permit the granting of a stay on terms, for example, that I could grant a stay and impose conditions on the practitioner's registration. Rather, it is submitted that if I determine the stay should be granted, the practitioner's suspension will be stayed pending the determination of the s 159B appeal. Reference is made to the express language of the sub-section which is "staying the decision". 56. The limited nature of the stay power is explained by Sackville AJ A in Medical Council v Lee as follows at [96]. His Honour says, albeit in the context of an appeal brought under s 159, of the National Law at [90]: On its face, s 150(2) of the National Law [NSW] suggests that the only two ways in which a suspension can be ended is by disposing of the complaint or by a determination of the Council. Section 150(2) cannot be read literally as the National Law [NSW] contemplates that a suspension may be lifted in other circumstances. For example, the Tribunal is expressly empowered on an appeal on a point of law to stay the decision (s 165L(2)). Nonetheless s 150(2) is important since it recognises that the Council plays a significant role in deciding whether to terminate or vary the suspension of a medical practitioner. 57. Later at [112] his Honour said: The absence of power in the Tribunal to stay a suspension decision made under s 150, except where the appeal is with respect to a point of law, does not mean that the suspension must remain in force pending determination of an appeal made by a medical practitioner. The issue is left to the Council to decide, either on an application for review (s 150A) or in the exercise of the Council's power to end the suspension (s 150C). This reflects a legislative judgment that the Council is best placed to assess whether the interim measure of suspending the registration of the medical practitioner should remain in place, having regard to the paramount consideration of protecting the health and safety of the public. [my emphasis]

Issues

In dealing with this interim stay application I discern the following matters are pivotal to the determination of the matter: 1. the period of time before which the stay application will be heard; 2. whether the interim stay can properly be determined on the evidence presently before me noting that the transcript of the hearing, but more importantly, the Council's reasons are not presently available but will be available for the stay hearing. 3. whether the notification given to the Pharmacy Board of Australia is deficient, and if so, what are the consequences; 4. is condition 2 beyond power and ultra vires, and what is the effect of condition 3; 5. whether failing to grant the interim stay will affect the health and safety of the public or whether granting the interim stay could adversely affect the patients who receive compounded medications; and 6. where do the interests of justice lie.

Time till the matters relevant to the Stay application can be fully ventilated?

First, I note that the hearing of the stay application is listed for 3 November 2021. Accordingly, any interim stay will have effect, unless otherwise extended, only until that day, that is, in 8 working days. Prima facie this fact does not support the interim stay application as the period is relatively short until the stay can be fully ventilated.

Can the interim stay be properly determined in the absence of the reasons for decision of the Council?

I was informed that the Council's reasons for the conditions imposed on Mr Hanna's registration will be available for the stay hearing on 3 November 2021 as will the transcript of the s 150 proceedings.
It is impossible, absent the reasons for decision, to assess whether the Council determined it was appropriate to take action under s 150 because of risk to the health and safety of the public and/or if it was satisfied the action was in the public interest.
In these circumstances it is not possible to adequately assess whether the conditions imposed were so unreasonable that no reasonable decision maker would have imposed them, or to meaningfully, even in a cursory way, assess the strength of other grounds on a question of law which may be relied on after the reasons are available.

Is the notice given to the Pharmacy Board of Australia deficient, and if yes, what are the consequences?

It is submitted by counsel for Mr Hanna that there has been non-compliance by the Council with s 176(3)(b) of the National Law.. Section 176 of the National Law is found in Division 14B.
Section 176 provides as follows: 176 Notice from adjudication body [NSW] (1) If an adjudication body, other than a court, makes a decision in relation to a health practitioner or student registered in a health profession, it must give written notice of the decision to the National Board for the profession. (2) For the purposes of subsection (1), in this jurisdiction a decision by an adjudication body is any of the following - (a) a decision by the adjudication body to impose or agree to conditions on a registered health practitioner's or student's registration; (b) a decision by the adjudication body to suspend a registered health practitioner's or student's registration; (c) a decision by the adjudication body to cancel a registered health practitioner's or student's registration. Note - This subsection is an additional New South Wales provision. (3) The notice must state - (a) the decision made by the adjudication body; and (b) the reasons for the decision; and (c) the date the decision takes effect; and (d) any action the National Board must take to give effect to the decision.
Written submissions from counsel for the Council argue that there is compliance with the requirements of the provision because the notice states: The information stems from a s 150 hearing which is a confidential process The outcome is related to Mr Hanna's performance
Counsel for the Council refers to [31] the decision in Bova v Pharmacy Council of New South Wales [2014] NSWCATOD 40. Care must be exercised in reliance on that paragraph of the decision in isolation from its context. One issue to be determined in Bova was whether an appeal under s 150 was an appeal de novo at a time when s 150(3) referred to a "reconsideration" by the Tribunal. The National Law has since been amended to make it clear that an appeal under s 150 is an appeal de novo.
I note that s 150 itself does not mandate the provision of reasons for a decision, but does require written notice of an action being given to the registered health practitioner (see s 150(6).
Counsel for Mr Hanna also submitted a breach of s 148H(1) by the Council. I do not accept the submission that reasons must be provided under s 148H(1). That provision relates to an inquiry into a complaint following which the Council may impose any order under s 148E. This matter was a matter determined under Sub-division 7 and orders which could be made under s 150 are limited to suspension and the imposition of conditions on a practitioner's registration.
I do accept for the purposes of the National Law (by reason of s 6A of the Health Practitioner (Adoption of the National Law) Act 2009 (NSW) that the Council is an adjudication body.
While the reasons for a decision need not be strictly equivalent to those of a judicial decision maker, the legislation makes it clear a National Board must receive not only the decision, but the reasons for decision and the date the decision takes effect.
I note that the material provided to me does not include any notification to the Pharmacy Board of Australia and the notice to the practitioner only refers to notification to the AHPRA the body charged with maintaining the National Register. Section 225(k) of the National Law mandates the recording on the registrar of any condition imposed on a practitioner's registration.
Absent seeing the information provided to the National Board , but assuming the reasoning provided is limited to "the outcome is related to Mr Hanna's performance" I cannot be satisfied that there has been sufficient compliance with s 176(3). However, I am not persuaded that this potential insufficiency of reasoning of itself warrants the granting of the interim stay. This deficit can be rectified by the Council providing its decision to the Board as soon as the reasons are available.
I note in passing that I do not find that the decision of Mitchell J in Solomon v Australian Health Practitioner Regulation Agency [2015] WASC 203 referred to by counsel for the Council assists in this matter given the different statutory provisions under consideration (see [52] of that decision).

Is condition 2 beyond power and what is the effect of condition 3?

Counsel for Mr Hanna argues that Condition 2 is beyond power and is ultra-vires. He says this is because the condition, as drafted, is not a condition imposed on the practitioner's registration but is a condition imposed on a pharmacy business.
The condition as drafted is as follows: "Not to allow compounding in any pharmacy in which he has a financial interest".
It is argued for the practitioner "that Condition 2 is an attempt by the Respondent to impose conditions on what lawful activities a registered pharmacy is permitted to undertake, through the guise of the imposition of a condition on a pharmacist". It is submitted that the condition requires the pharmacist to somehow restrain a legal entity, for which, as a director, he would have duties under the Corporations Act.2001 (Cth) The submission poses the question "that if a pharmacist, against the wishes of the Applicant compounds a medication, is the Applicant in breach of the condition?".. It is submitted the condition is unworkable and that "compounding" is not even defined. I accept the merit of the submission insofar as the word "compounding" is not defined in the condition but infer the Council was referring to compounding as explained in the Pharmacy Board of Australia Guidelines on Compounding Medicines.
The submissions of the Council take issue with the submissions made on behalf of Mr Hanna on this topic and set out relevant provisions of the Poisons & Therapeutic Goods Act 1966 (NSW) and Schedule 5F of the National Law.
Subject to any further argument on this topic at the stay hearing, for the purposes of this interim stay application I do not accept the submission the condition is a condition imposed on a pharmacy and therefore ultra vires. Rather, it appears the condition imposes a restraint on Mr Hanna, as a registered pharmacist who holds financial interest as defined in Schedule 5F of the National Law, in respect of the five pharmacies either himself, or by any of his employees, from compounding any pharmaceutical product.
Secondly. I note that the clarification by the Council about condition 3 of the conditions imposed by the Council means, that except for compounded medications, pharmacists employed in the pharmacies operated by the practitioner are not restricted from dispending medications prescribed for patients such as patients in nursing homes.

Whether failing to grant the interim stay will affect the health and safety of the public or whether granting the interim stay could adversely affect the patients who receive compounded medications.

As already noted, absent the Council's reasons it is unclear on what basis the conditions were imposed. Doing the best I can it appears the Council had concerns about Mr Hanna's performance and required him to undergo a performance assessment.
I am satisfied, given the Council's clarification that the conditions do not restrict any pharmacist employed in the five pharmacies in which Mr Hanna has a direct financial interest from dispensing prescriptions, other than for compounded medications, for patients who do not personally attend the pharmacy as provided in the COVID 19 arrangements. Thus, patients of nursing homes will not be precluded from receiving necessary medications. The restriction in condition 3 is imposed on Mr Hanna not his employees
Counsel for Mr Hanna argues that preventing any compounding will affect patient care. The details provided relate to patients receiving acne treatment, erectile dysfunction treatment, fertility treatment, motion sickness medication and for children suffering from Attention Deficit Hyperactivity Disorder. I note first, that compounded medications are only to be prescribed in limited circumstances such as allergic reaction to pharmaceutical products approved by the Therapeutic Goods Administration and registered on the Australian Register of Therapeutic Goods or at a different dose to that available in commercial products.
I further take into consideration that in his response to matters raised Mr Hanna states in his letter of 1 February 2021 to the Health Care Complaints Commission that although one of his pharmacies dispensed and mailed the compounded medication, repeat prescriptions may be dispensed through a "partnering pharmacy". I observe this is, in some respects, contrary to the material deposed to by Mr Hanna in his affidavit of 15 October 2021 at par 32. This contrary evidence may be fully explored at the stay hearing on 3 November 2021. I note that the medical practitioners' statements on which Mr Hanna relies and which are annexed to his 21 October 2021 affidavit refer to difficulties in dispensing repeats if the original prescription is an electronic prescription. However, it not suggested the practitioners are precluded from having any necessary prescription directed to another compounding pharmacist, rather their statements indicated this would be disruptive.
Thus, I am not satisfied that for the purposes only of the interim stay that the health and safety of patients are likely to be compromised by the conditions imposed. In making this finding I take into account the relatively short period before the stay will be heard, the lack of restriction on Mr Hanna's employed pharmacists from dispensing pharmaceuticals other than compounded medications and the ability of patients to source product if necessary from another compounding pharmacists.
I accept that when the transcript and the Council's reasons are considered at the stay application now listed for 3 November 2021 that different considerations relevant to patient safety may arise.

The balance of convenience

Mr Hanna sets out with some particularity the financial consequences of the conditions imposed on his registration by the Council. I accept that particularly in relation to Filled Pharmacy the estimate loss of revenue is $2,554,000 per month and this is a factor to be taken into consideration. I also take into account Mr Hanna's evidence that he will have to stand down staff. The latter factor is a very relevant matter and can be fully explored at the stay hearing when the Council's reasons including any consideration of this fact can be fully considered.
I have taken into account the undertaking proffered by Mr Hanna to the Tribunal. I accept he has given the undertaking in good faith. However, if an interim stay is granted relying on an unenforceable undertaking it would not address issues relating to compounded medications which appear to have been the Council's primary focus.

Will the appeal be rendered nugatory if the interim stay is not granted?

I accept that Mr Hanna will suffer some financial loss and inconvenience if the interim stay is not granted. But I do not find his appeal will be rendered nugatory if the interim stay is not granted.
A date has been fixed for the stay hearing. I am advised by counsel for the Council that the transcript and reasons of the Council will be available for that hearing. At that time some assessment can be made of the strength of the grounds of appeal on a question of law as well as issues relating to the health and safety of the public, the public interest, and the balance of convenience.

Conclusions

Although I accept the conditions imposed are very significant, and appear at the severe end of the scale in terms of the three complaints articulated as the subject of the s 150 hearing, the need for the conditions cannot be properly assessed at this time. The prejudice asserted by Mr Hanna is confined to a short period before the stay hearing.
After considering all matters relevant to whether or not an interim stay should be granted, I conclude, an overall weighing of all presently known factors demonstrates the balance of convenience falls in favour of the Council particularly having regard to s 3A of the National Law. . It is a relatively short period before the stay application will be heard and determined. At that time all matters relevant to the stay sought, including consideration of the Council's reasons for the conditions imposed, will be fully and properly evaluated.

Orders 1. The oral application for an interim stay is refused.

I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales. Registrar DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 27 October 2021

Therapeutic Goods Act 1966(NSW)

Health Practitioner (Adoption of the National Law) Act 2009(NSW)

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