Turner v Pharmacy Council of New South Wales

NCAT Occupational|2022-11-09

Background

The Applicant is a registered pharmacist. He currently is the sole proprietor of 3 pharmacies and a director of, and shareholder in, another in New South Wales, and owns 6 others in South Australia, Victoria, Queensland and Western Australia. The Applicant is a 58-year-old pharmacist with extensive experience and has been practising as a pharmacist with registration in New South Wales since 1998.
The Applicant's evidence is that in relation to his pharmacies he is "in charge of the pharmacist in charge" of all his pharmacies, "sets the standard for pharmacists he employs", and provides control and oversight of all his pharmacists and employees.
On 27 September 2022 the Council received a letter and an attached investigation report from the New South Wales Pharmaceutical Regulatory Unit (the PRU) in relation to pharmacies in New South Wales currently or previously under the proprietorship of the Applicant.
As a result of the receipt of this information the Council instigated s 150 proceedings which resulted in the Decision.

The Section 150 Proceedings

An urgent hearing before the delegates of the Council was held on Monday, 17 October 2022. The Applicant attended and was assisted by a barrister from the New South Wales Bar during the hearing as a support person. The barrister played a fairly active role during the proceedings.

Analysis of Council's Decision

It is necessary to consider the written reasons of the Council handed down on 4 November 2022 with the following in mind: 1. they must be read as a whole; 2. they must be read in context, including the relevant applicable legislative provisions; 3. they must be considered in the context of all the materials available and the questioning of the Applicant during the s 150 proceedings; 4. context extends to the transcript and all the material before the delegates; 5. they must be read fairly; 6. the reasons should be read together with the PRU Report in circumstances where specific reference is made to particular paragraphs of the PRU Report.
It is not necessary for the delegates to have made full or final inquiries into the matters, or to make final factual findings or express ultimate conclusions on matters raised for their consideration (Lindsay v NSW Medical Board [2008] NSWSC 40 at [50]). The issue is not whether the allegations were proved but whether the evidence established a risk requiring the imposition of conditions (Kirby v Dental Council of NSW [2018] NSWCA 1869 at [15] per Brereton JA, Payne JA agreeing).
As was held in Medical Council of New South Wales v Smithson [2021] NSWCA 53 the task of the Council under s 150 may be stated as follows: As s 150 is a protective provision, it is appropriate ordinarily for the Tribunal, in deciding whether it is satisfied that it is appropriate to make an order under the first or second limb, to make an assessment about the nature and degree of risk to the health or safety of any person or persons or to the public interest (in the sense of the chance of the suggested harm being realised) and the consequences of the suggested harm being realised (in the sense of the seriousness of the harm that will ensue if the risk is realised): see X v The Commonwealth (1999) 200 CLR 177; [1999] HCA 63 at [41], which addresses risk in a different context. Reaching that state of satisfaction involves the Tribunal making an assessment of all of the evidence before it. Per Payne JA, Simpson AJA and Garling J.
The decision of the Council to impose conditions on the registration of the Applicant involved, in effect, two discretionary decisions. The first was as to the delegates' satisfaction as to the appropriateness or otherwise to do so for the protection of the health or safety of any person or persons, or if satisfied otherwise it is in the public interest. The satisfaction involved a degree of subjectivity and thus, in a broad sense is a discretionary decision (see Coal and Allied Operations Pty Ltd v AIRC (2000) CLR 194 at 205 [20] per Gleeson CJ, Gaudron and Hayne JJ in respect of similar legislative provisions).
If the requisite satisfaction was reached, that necessitated the making of a further discretionary decision as to the appropriateness of any conditions which should be imposed (Coal and Allied at [20]).
Because the decision-maker charged with the making of the discretionary decisions has some latitude as to the decision to be made the correctness of the decision can only be challenged by showing error in the decision making process (Coal and Allied at [21]).
Where the question arises as to whether a decision-maker in the position of the Council reasonably could have formed the opinion as to satisfaction or appropriateness of the statutory criteria stipulated in s 150 a challenge will lie where findings or inferences of fact are not supported by some probative material or logical grounds (Minister for Immigration and Multicultural Affairs v Eshetu (1999) 197 CLR 611 at 656-7 [145] per Gummow J). If other decision-makers may reach a different view, and have done so reasonably, is not to the point.
The Council's satisfaction under s 150 is as to the "appropriateness" of taking action, not whether it is "necessary" to do so, the former being a less stringent test (Steel v Medical Council of NSW [2020] NSWCATOD 77 at [35] per Boland AM ADCJ).
From the reasons there can be no doubt in my view that the delegates of the Council were aware of the statutory context in which they were to conduct the inquiry and that action taken by the delegates under s 150 is intended to be interim in nature.
The task as was recorded involved a risk assessment having regard to the guiding principles stated in s 3A of the National Law that the protection of the health or safety of the public must be a paramount consideration.
The delegates were also aware that they were required to consider the appropriateness to take the action under s 150 in respect of the Applicant for the protection of the health or safety of the public or otherwise in the public interest and then to consider a question of conditions that could be imposed on the practitioner's registration that would sufficiently mitigate any identified risks to the health or safety of the public (Decision at [7] and [9]).
It is clear from the Decision that the delegates were aware that the task involved a risk assessment having regard to the particular matters brought to their attention (see the heading above paragraph [21] and numerous references to risk including patient-related risk and product-related risk at paragraphs [28], [31], [33], and [34] to [39]).
In my view, a fair reading of the Decision also suggests that the delegates addressed the seriousness of the conduct brought to their attention by the PRU report and the seriousness of the consequences of the suggested harm being realised and a different route available under the National Law could be followed.
First, the delegates set out the key findings of the PRU Report that identified "extensive major contraventions" of the Poisons and Therapeutics Goods Regulation 2008 with respect to the supply of certain medicines (Decision at [2]). With respect to compounding in the key findings involved compounding medicines where there appeared to be little or no clinical and/or pharmaceutical evidence to support the safety, efficiency and rationality of extemporaneous formulations, and compounding where an appropriate commercial product appeared to be available contrary to the Pharmacy Board of Australia Guidelines (and see Decision at [23] and referring to 5 pages of the PRU Report).
Secondly, the delegates identified risks of various kinds. They identified at [21] that they concentrated on the matters they believed "were potentially a significant immediate risk to the health or safety of the public" (emphasis added).
The delegates then said that for that reason they concentrated on compounding, the supply of high-risk medications, and arrangements between the Applicant and two other entities, Mosh and Burst Health.
The Decision recorded that it appeared that the Applicant's pharmacy had compounded a bulk supply of high-risk product without an appropriate risk assessment for individual patients being first undertaken and, aside from departing from regulatory requirements, that placed the patients at risk of adverse outcomes from excessive supply of a topical anaesthetic (Decision at [25]).
In that regard, the delegates emphasised ("to be clear") the fact that there had been fatalities recorded from compounded anaesthetics where the patient has used too much of the product (Decision at [26] and [29]).
The delegates distinguished between product-related and patient-related risks. They noted that product-related risks in the instance of a prescription from a Doctor Armenores included potency of the active ingredients, pharmacological effects, and large batch preparation and supply. The patient-related risks were that there is no evidence that the pharmacist had completed a risk assessment for each individual patient and considered and documented factors such as age, weight, co-morbidities, and current medications (Decision at [31]).
In respect of the supply of high-risk medications the delegates set out from paragraph [33] and following the supply of such medications to a number of the patients identified in the PRU Report, including two particular patients, and multiple supplies of these products including opioids (see Decision at [36] read together with paragraph 17 of the PRU Report).
The delegates paid attention to another supply of another opioid (remifentanil) contrary to recognised therapeutic standards (Decision at [41]).
The delegates also paid attention to the supply of fentanyl. Fentanyl is described in the PRU Report as a highly potent synthetic opioid and the use of fentanyl patches (which were supplied) carries several risks including overdose, with a small margin between an appropriate therapeutic dose and a toxic dose (PRU Report pages 24 and 25).
The risk was also addressed by the delegates by reference to the fact that the conduct identified breached various guidelines in the Poisons and Therapeutic Goods Act 1966 and the Poisons and Therapeutic Goods Regulations 2008 (Decision at [59] and [60]) dealing with Schedule 4 and Schedule 8 drugs, the latter being drugs of addiction.
The delegates then concluded: [62] The public has entrusted the custody and supply of potent medicine to the profession of pharmacy and expects pharmacists to behave at all times in a legal and ethical manner in the discharge of their responsibilities. Pharmacists have a duty of care to their clients and to the public which is delivered through maintaining the highest standards of practice, knowledge, understanding, diligence, and care. [63] The public has an expectation that proprietors will always adhere to PBA Guidelines for pharmacists and have appropriate policies and procedures in place to ensure compliance with the regulations. [64] The panel concluded that [the Applicant] poses a risk to the health or safety of the public. As outlined above, we note in particular:

The bulk supply of a high-risk compounded anaesthetic product in a quantity approximately 100 times the appropriate amount for an individual patient
The supply of five ampoules of the opioid remifentanil to a medical practitioner, for patient use
Multiple problems with the supply of other high-risk medications to individual patients
A significant number of "owing" scripts for S4D, S8 and compounded medications

The delegates then said in their reasons "the matters we have focused on and the other concerns in the PRU Report are of significant concern and cover a very wide range of issues. We form the view that there is a risk to the health or safety to the public because [the Applicant] either allowed the issues of concern to continue or was unaware of what was occurring in his pharmacies" (Decision at [65]). (It was, of course, not necessary that there be actual harm, but a potential for harm - Smithson at [20] (7).)
In my view, a fair reading of the Decision also indicates that the delegates had an appreciation of the distinction between simply "risk" and "significant risk" to the health or safety of the public. This is demonstrated by the delegates' treatment of the Mosh and Burst Health issues which led them to conclude that "there was not a significant risk to the health or safety of those aspects of the PRU Report and that they may need to be investigated by the HCCC" (Decision at [50]). In other words, no need for immediate action because of the absence of a significant risk and a different route available under the National Law could be followed to deal with that alleged conduct.
It is also necessary to bear in mind that the delegates concluded by referring the matter under s 150D of the National Law as was required to be dealt with as a complaint for investigation which suggests, at least, that the delegates were operating on the need for urgency in respect of the particular matters identified and leaving for investigation through that mechanism that which did not require immediate attention.
In respect of the risks associated with compounding the evidence of the Applicant was that because of the risks it was not possible for him to be able to be on top of "this sort of thing" and it was too risky, it needed to be done by somebody that actually owns the facility. Rather, the chief compounding pharmacist should be the owner (Transcript P65 and P66).
I now return to deal with the grounds of the appeal under s 159B.

Ground 1 - No Lawful Reasons

This was a ground relied upon prior to the Council publishing its reasons on 4 November 2022.
In my view those reasons are extensive and there is no arguable case that they are insufficient. There is also in my view no arguable case in respect of a point of law because they were not published simultaneously with the imposition of the conditions effective from 21 October 2022.

Ground 2 and Ground 6 - Misunderstood Statutory Duty

In support of this ground Senior Counsel for the Applicant emphasised that the power under s 150 is an emergency power which needed urgent action. It was argued that the delegates had failed to identify any conduct of the Applicant which posed an unacceptable risk to the health and safety of the public, the nature and extent of the risk and the connection between the Applicant's conduct and the identified risk. It was argued that the delegates had to identify specific concerns about risk, how serious was the risk, and what is the risk if the conduct continues. A conclusion should then have been reached with sufficient clarity to identify a nexus between any conditions and what was said to be unacceptable risk. Ground 2(c) specifically raises the question of the Council misunderstanding its statutory task by failing to identify the consequences of the harm being realised in the sense of the seriousness of the harm that will ensure if the risk is realised so as to determine whether there was such an unacceptable risk which required immediate action.
For the purposes of the stay I am, of course, not required to reach a concluded view on any of the matters raised but must make a preliminary assessment taking into account the strength or otherwise of the grounds of the party seeking the stay with the limitation in s 159B in mind.
It is true that the Decision does not expressly have the delegates identifying the risks to which attention was being paid by reference to the phrase "unacceptable risk". However, as the analysis set out above shows, the reasons did address the seriousness of the conduct and identified the seriousness of the harm that could ensure if the risk was realised. The Decision also demonstrates that the delegates were aware of the distinction between the need to act where there was a significant immediate risk (Decision at [21]) and no "significant risk" to the health or safety of the public leaving the issues of concern for investigation (Decision at [50]). As far as the Council was concerned there was urgency required and it acted within weeks of receiving the PRU Report, and in my view there was sufficient of an understanding of the power which did not go contrary to the analysis of the power in Pridgeon v Medical Council of New South Wales [2022] NSWCA 60.
It appears that the Applicant seeks to place particular relevance on the argument that the Council failed to identify any conduct of the Applicant which posed an unacceptable risk to the health and safety of the public (or any person). The Applicant argues that other than the PRU Report the Council did not identify any conduct or matter concerning the Applicant which is relevant to the powers under s 150 of the National Law. The Applicant argues that the PRU Report may raise questions about the conduct of pharmacists who had been employed by the Applicant and medical practitioners who had prescribed various drugs of addiction and thus, it seems, his conduct was beyond the reach of s 150.
However, as the Decision demonstrates the PRU Report gave rise to questions as to the Applicant's conduct. The concerns identified in the PRU Report appear to me to have called out for an enquiry as to how the various breaches were allowed to occur in the Applicant's pharmacies. The Council addressed the issue as follows: 1. the concern that the Applicant appears to have been unaware of a supply of a very significant quantity of a high-risk drug but it was his obligation to ensure that appropriate policies and procedures were in place and were being followed (Decision at [28]); 2. as a very experienced pharmacist proprietor even the most basic checking should have highlighted the risks of the types of medication being dispensed, not to mention the 'red flag' of the number of prescribers involved (Decision at [37]); 3. in respect of scripts "owing" for Schedule 4 D and Schedule 8 drugs at his pharmacy still owned at the time which were not rectified there were concerns about the Applicant's standard of practice and knowledge in that regard (Decision at [39]); 4. the Applicant had failed to ensure that there were appropriate policies and procedures in place in respect of bulk-compounded anaesthetic products (Decision at [43]); 5. there was a risk to the health and safety of the public because the Applicant either allowed the issues of concern to continue or was unaware of what was occurring in his pharmacies (Decision at [65]).
In the circumstances it does not appear to me that the categorisation of the conduct, namely that of others, and not of the Applicant has much substance to it.
It is, of course, the case that if the delegates misunderstood their statutory task there would be a sufficient point of law to support a stay in a s 159B appeal.
However, in the circumstances, it appears to me on a preliminary basis that, with the factors set out at paragraph [35] above in mind, the reasons do not disclose that the Council misunderstood its statutory duty. Accordingly, I regard this ground of appeal as arguable but taking into account all the factors I have identified at above I assess the strength of the argument as fairly low.

Ground 3 - Failed to Afford Procedural Fairness

This ground must be viewed in the context of the Applicant having been put on notice by the PRU of at least some of the matters it intended to investigate and discuss with him if he wished to provide an explanation for the conduct identified (paragraph [27] above) and also in the context where he had received a very detailed report with supporting material, the PRU Report, prior to the s 150 hearing. As I point out above, he was also offered a number of opportunities to provide to the Council matters which he wished the delegates to consider.
In addition, the transcript of the proceedings demonstrates that the delegates raised during the proceedings for comment or a response from the Applicant a number of their concerns to which he did respond.
In my view it was not required of the Council to inform the Applicant prior to the Decision as to what weight would be applied to the allegations in the PRU Report which were clearly identified by reason of the shortcomings or breaches the PRU spelt out (compare ground 3(a)).
It was, in my view, open to the Council to reject the suggestion that there had been provided insufficient particulars to the Applicant in the context of the PRU Report provided to him which, as the Council identified, was very comprehensive and the Applicant had ample opportunity to make a detailed response if he chose to do so (compare ground 3(b)).
In my view, ground 3(c) has no merit in the context of the key findings of the PRU Report (quoted at paragraph [2] of the Decision) and which was available to the Applicant prior to the hearing. In my view, it was not required of the Council to notify the Applicant in advance that it would give weight to the matters set out at paragraphs [45] and [66] of the Decision (as claimed) as the issues were live issues in the proceeding and the conclusions clearly open on the materials before the Council.
In my view, it is reasonably open to view the process as having afforded the Applicant with sufficient opportunity to respond to the allegations. Accordingly, in my view, the Applicant has not made out a reasonably arguable case of a denial of procedural fairness.

Ground 4 - Unreasonableness

The Applicant contends that the Respondent has failed to identify any conduct of the Applicant which posed an unacceptable risk to the health or safety of the public or any person, or any conduct of the Applicant which posed an unacceptable risk to the public interest in protecting the health or safety of the public or any person. This contention cannot be sustained in the context of repeated references to conduct on the part of the Applicant, particularly by way of omission in ensuring that certain conduct did not occur in relation to the pharmacies for which he had oversight (Decision at [28], [37], [39], [43] and [65]).
As is identified above, the Council in its Decision also identified the nature or extent of the risk that the Applicant posed by reason of that conduct and the connection between the conduct and the significant serious risk identified.
The Applicant did not address the question of unreasonableness in any detail.
In response, the Respondent set out the relevant principles for unreasonableness, the test being one as described as necessarily stringent (Minister for Immigration and Border Protection v SZVFW (2018) 357 ALR 408 at [11], [52], [70] and [135]). As was held in Minister for Immigration and Citizenship v SZMDS (2010) 240 CLR 611; [2010] HCA 16 at [30] per Crennan and Bell JJ the reasoning process must describe that "no rational or logical decision maker could have arrived at (them) on the same evidence".
The absence of unreasonableness in my view is demonstrated, in part, by the fact that the delegates had before them an acceptance by the Applicant that he could not manage the risk in relation to compounding. Further, by way of example, the reasoning in paragraph [21] as to whether conduct gave rise to "an immediate risk" is a rational approach.
Where there has been identified in the reasons an unacceptable risk by reason of a failure of oversight it could not be concluded that no rational or logical decision maker could have arrived at the outcome.
The complaint that the conduct identified may have been that of pharmacists employed in the pharmacies and thus was not evidence of the Applicant's conduct overlooks the fact that the panel was critical of the conduct of not appropriately overseeing and ensuring that the pharmacists conducted themselves in a manner which did not give rise to the serious risks identified.
I accept the contention by the Respondent that in respect of the supply of high-risk medications dealt with at paragraphs [33] and following of the Decision, the reasons can be regarded as within the range of reasonableness and thus would not satisfy the requisite test.

Grounds 5 and 7 - No Nexus - No Power

Ground 5 is premised on there being "no nexus to any identified risk and therefore (the conditions) were neither necessary nor appropriate" to protect the health and safety of the public.
The statutory requirement is that the conditions relating to the practitioners practising the health profession are those the Council considers appropriate, a discretionary judgment as pointed out above. The Tribunal may have a different view of the particular conditions but for present purposes that is not the issue. In addition, the test is not what the Council considered necessary, but appropriate, the lessor test.
Although the delegates did not expressly set out the process by which they arrived at the imposition of Condition 1, there is open a logical connection between their conclusions reached about risk and the absence of oversight or appropriate oversight on the part of the Applicant. In the light of that conduct and conclusion, it is at least implicit in the imposition of Condition 1 that the Applicant should not be in a position where he has the ultimate responsibility of oversight in the pharmacies and Condition 1 is addressed at that issue.
I also think caution should be adopted in viewing the conditions individually and not as a suite of measures considered appropriate. If it is accepted, as the Council appears to have done, with some acknowledgment by the Applicant, that there were legitimate concerns of significant failures of oversight in compounding, and provision of high-risk drugs, and the conditions are then assessed by reference to those concerns, do the conditions which in effect remove oversight altogether, and remove provision of Schedule 4D and Schedule 8 drugs by the Applicant, come within what could be considered appropriate? It is not clear to me that the Applicant has made good an arguable case in that regard.
Conditions 2 and 3 should in my view be read together. In light of the express concerns and conclusions arrived at in respect of the compounding of materials, Conditions which either prevent the Applicant from doing so, or does not allow compounding in any pharmaceutical products in any pharmacy in which he holds a financial interest, is a natural nexus to the risks identified.
It does not appear to me to be correct to say that the conditions are not responsive to any risk identified concerning the Applicant, because, it is said, it does not concern the Applicant's conduct. The Applicant's failure of oversight suffices to answer that contention.
In respect of Condition 3 the Applicant also argues that the Council has no power to impose conditions on how a pharmacy business operates. It is contended that the National Law does not provide the Council with the power under s 150 "to regulate based solely upon a pharmacist's financial interest in a business".
It does not appear to me that the Council acted 'solely' on the Applicant's financial interest in a business. The Applicant's own evidence dispels this argument (see paragraphs [21] and [65] above). In addition, as I pointed out above, the delegates gave attention to conduct and not merely 'financial interest'.
The Guidelines for Proprietor Pharmacists provide, relevantly, that a registered pharmacist who is a proprietor of, or who has a pecuniary interest in, a pharmacy business, must maintain, and be able to demonstrate an awareness of, the manner in which that pharmacy business is being conducted, and where necessary, intervene to ensure that the practice of pharmacy is being conducted in accordance with applicable laws, standards and guidelines (emphasis mine).
It is thus consistent with the Guidelines that the practitioner be required to intervene so as not to allow compounding products in pharmacies he or she is the sole owner or a director and shareholder (a pecuniary interest).
I am thus currently not persuaded that on the materials in this application the Applicant raises a seriously arguable ground in respect of a point of law in respect of Condition 3.
In respect of Condition 4 and Condition 5 (and not 4(a) and 5(a)) there appears to me to be two issues raised. First, the question of "possess" appears to give rise to some uncertainty and the Respondent has consented to a stay in respect of that part of the condition in each case.
There does, however, arise the question as to how these conditions relate to the conduct of the Applicant. The conditions extend to manufacture or dispensing of Schedule 4 and Schedule 8 drugs which, at least in part, appear to be part of the compounding practice which was the subject of the panel's concern. The conditions, however, on their face appear to apply only to the Applicant and, in contrast to Condition 3, do not appear to extend to the restrictions in any pharmacy the practitioner holds a financial interest.
In respect of Conditions 4 and 5, once it has been identified that there is a risk to the health or safety of the public or part of the public by reason of a failure of oversight in respect of the supply of drugs of addiction there is arguably a logical nexus to a condition prohibiting the person who failed to identify those shortcomings from doing the supply, manufacture or dispensing of those particular categories of drugs.
The position is not entirely clear but I would not currently be prepared to say on a preliminary basis that there is a valid basis for challenging these conditions because the Council erred in regarding them as appropriate. Confined as applicable only to the Applicant there is some connection between Conditions 4 and 5 with the identified risks set out in the Decision and the Applicant's conduct and it is not readily apparent that there is raised a seriously arguable point of law to support a stay under s 165L in this respect.
In respect of Conditions 4(a) and 5(a) the Respondent consents to a stay which in my view is appropriate. There is certainly an arguable case that these conditions are not within the power of the Council. Under the Poisons and Therapeutic Goods Regulations 2008, the Secretary of Health has the power under that legislation to restrict possession or supply under s 18AA of the Poisons and Therapeutic Goods Act 1966. Even if that were to be done if the Respondent decides to change the conditions in the future, or the matter is overturned on appeal, the Respondent has no control over whether the Secretary for Health would also remove this restriction.
The issue then is whether the Council has the power to impose a condition on the registration of a practitioner which puts in the hands of another agency or person the decision as to whether to reinstate the entitlement to the possession of the relevant drugs after the pharmacist has agreed, in compliance with the condition, to restrict such possession. In my view, there is an arguable case that the power does not exist. I am therefore prepared to give effect to the consent position reached on those conditions.
In my view, Condition 6 cannot be said to be beyond power or to have no relevant nexus to the conclusions reached about the conduct of the Applicant or the risks. Practice under Category C will require a level of supervision which cannot be regarded as so far removed from the conclusions of the panel such that there could be said to be no relevant nexus and no point of law is identified in this regard.

Ground 8 - No Complaint

The Applicant contended that whilst the Respondent was not required to act on a complaint in order to take the action under s 150, the Respondent remained in error in categorising the PRU Report as a complaint. The Applicant argues that maintaining that the PRU Report was a complaint appears to have provided it with "some elevated status". The Decision of the Council describes the position at paragraph [2] as having "received a letter and an attached investigation report".
In my view, the PRU Report was not intended as a formal complaint, was not in fact treated as such and it was not given any elevated status. It did, however, raise serious issues. No serious point of law arises in relation to this matter in my view.

Ground 9 - Understanding of Statutory Task

In my view, the Applicant has not raised any serious issue to be determined on the grounds that the Council misunderstood its statutory task in respect of the assessment by the panel about the Applicant's practice in overseeing of the provision of the compounding and provision of drugs, and his non-compliance with the appropriate policies and procedures for the protection of the public. In particular, the analysis by the panel at paragraphs [52] to [60], including the Guidelines on responsibilities of pharmacists when practising as proprietors, were within the scope of their enquiry and no arguable error in my view arises in this regard.

Ground 10 - Failure to Take Into Account Relevant Considerations

The Applicant has not raised any serious point of law in this regard. I am not convinced that this ground adds weight in favour of a stay.

Ground 11 - Practise Below Standard

The Applicant's grounds contend that the Respondent misunderstood its statutory task during the hearing on 20 October through focusing on whether the matters identified in the PRU Report demonstrated that the Applicant's practice was below the standard reasonably expected of a pharmacist.
In my view that is far too narrow a categorisation of the overall approach taken by the panel during the 20 October hearing and to the extent that the Applicant's practice was below the standard reasonably expected of a pharmacist and where it gave rise to perceived significant risks to the public that was clearly a matter within the scope of the statutory task which the panel was required to undertake.

Balance of Convenience

In support of the question of where the balance of convenience lies the Applicant recognises that the protection of the health and safety of the public is of paramount consideration in light of s 3A of the National Law. However, the Applicant seeks to argue that the public safety is likely to be advanced if a stay is granted. For the reasons that follow I have significant reservations that such a conclusion is currently available for the purposes of my decision.
In support of its contentions the Applicant relies essentially on the following matters: 1. Although the PRU commenced an investigation into the pharmacies some 12 months ago there is no evidence that there have been any prosecutions taken and so it should be inferred that the Secretary with responsibility under the Poisons Act does not consider it necessary to take such a step. In my view this is a factor which should be given little weight in the context where the PRU Report was presented to the Council which took urgent action in relation to that Report. 2. The Applicant then argues that he did not personally dispense any of the drugs of concern referred to in the PRU Report and it is difficult to see how conditions which prevent him from possessing or dispensing such drugs are in the public interest. 3. The Respondent replies to this submission that it misses the point in the context where the Applicant has overall direction and control over pharmacies at which conduct has occurred which poses a significant risk to the health and safety of the public and it is not necessary to establish such a risk that a person personally dispense the drugs in question. 4. In my view, there is some force in the Respondent's position. In addition the submission by the Applicant appears at least in one respect to be inaccurate in that the PRU Report did identify that he personally dispensed a drug of concern (this occurred in October 2020 as one supply to a Mr Lin who was constantly and repeatedly being prescribed by various medical practitioners drugs that he ought not to have had access to (paragraph [17] of the PRU Report) and see paragraph [36] of the Decision). 5. In addition, the Council identified in this regard that the Applicant was a very experienced pharmacy proprietor and even the "most basic checking should have highlighted the risks of the types and quantity of the medications being dispensed, not to mention the red flag of the number of prescribers involved". 6. The Applicant also contends that a significant number of patients, perhaps 50 per day, will be inconvenienced if the conditions do not remain stayed because the patients will not be able to access their compounded medications and, equally, employed staff, including at least one pharmacist, will be required to be idle. 7. It is not clear on the evidence currently available to me why patients will not be able to access compounded medications from other pharmacies.
The submissions by the Applicant about a stay favouring the public interest must also be assessed in light of the evidence given by the Applicant during the s 150 proceedings in which he recognised that the compounding at his pharmacies created a risk, he could not oversee the matter properly and was going to cease compounding. However, the current submission is that the Applicant should be permitted to continue compounding because of the potential inconvenience to patients and staff. All of this is advanced in the absence of any evidence that if these practices are allowed to continue there would be sufficient safeguards in place to overcome the concerns that the Council had leading to the imposition of the conditions concerning compounding.
The Applicant has not sought to put before the Tribunal evidence which counters those concerns. The absence of evidence demonstrating that the safety of the public will be appropriately protected if a stay is granted is, in my view, a significant factor weighing against a stay.
It is also contended on behalf of the Applicant that he intends to sell the compounding pharmacy (Super Pharmacy Compounding) and his other pharmacies will not be compounding but it would take some time while he is currently negotiating with a potential buyer and completes any such sale. Inherent in this contention is an intention to keep compounding and Condition 3 is likely to jeopardise the sale which could result in staff losing their jobs and the patients being unable to have their compounded scripts applied. This evidence appears to me to be that it should be "business as usual" in this pharmacy to maximise the prospect of a sale but, without the identification of safeguards against the unacceptable practises identified. This evidence appears to me also to be at odds with a proposition that because the Applicant indicated that he was going to cease compounding, the identified risks in that respect have been ameliorated. Quite the contrary appears to be the case.
The Applicant then contends that the conditions do not make clear what it is that the Applicant is and is not allowed to do as a proprietor pharmacist and Condition 6 was particularly unclear. It is difficult to see why Condition 6 is said to be particularly unclear. It is also said in this regard that it would seem that if the conditions are not stayed the Applicant's ability to undertake oversight will be significantly curtailed and that that could not be in accordance with the public interest.
It is true that the Applicant's ability to undertake an oversight role will be significantly curtailed by the conditions. However, in light of the conclusions by the Council that he had failed in his duty in that respect to a significant degree, it appears that these conditions are specifically aimed at curtailing those activities so that they be performed by others who are qualified to do so. I do not accept that preventing the Applicant from performing an oversight role will not be in accordance with the public interest.
Finally, the Applicant submitted that in light of the objective seriousness of any of the alleged risks being extremely low, and the irreversible reputational and financial damage to the Applicant, coupled with the unworkability and uncertainty of the proposed conditions, the interests of justice favour the granting of the stay.
The seriousness of the alleged risks were assessed by the professional panel appointed by the Council to consider and deal with the PRU Report. In the circumstances, it is difficult to question their assessment that the risks were serious (not "extremely low"). Secondly, reputational harm and financial damage do not tip the balance in favour of the Applicant (Liu v Chinese Medicine Council of NSW [2019] NSWCATOD 13). It is also not clear, in the absence of evidence, what the financial damage will be. It is correct in my view that the conditions will create significant difficulties for the Applicant but those have to be weighed against the overriding principle, namely the protection of the public.
I do not think that an order staying the operation of the conditions are reasonably necessary to secure the effectiveness of the appeal. The Applicant contends that if Conditions 1 and 6 are not stayed pending the appeal then they are likely to have serious ramifications for the safe and effective management of the pharmacies. Conditions 1 and 6 limit his ability to carry out this work.
In the absence of evidence to demonstrate that alternative measures are not available to overcome these issues I do not think a stay of the conditions identified is necessary to secure the effectiveness of an appeal.
I recognise that a power to grant a stay may include a power to make such an order subject to conditions and the Applicant's Counsel indicated a willingness for that to occur. I would have been inclined to adopt such an approach if I was satisfied that there was real strength in the points of law raised, which I am not convinced of, and if there was sufficient evidence upon which I could rely to secure the interests of the public as a paramount issue with other conditions, but as I point out above there is not.
I recognise that the maintenance of the conditions will have a significant impact on the Applicant pending the hearing and determination of his appeals. It is likely, in my view, that given that impact an expedited hearing of the appeals will, if sought, be granted, so that the period impacting on him may be somewhat reduced.
Given that the Applicant provides a dispensing role only as cover as necessary, for example, if an employed pharmacist calls in sick, the impact of Condition 1 is also likely to somewhat lesser than may be the case if he was a full-time pharmacist in charge of a pharmacy.
Overall, I do not think that the absence of a stay unfairly balances the rights of the parties against the Applicant.
In the event that there has been, or are changes to the policies and procedures, and their enforcement, applicable to the Applicant's pharmacies, and particularly the compounding pharmacy, so as to provide an assurance that the concerns identified by the delegates in relation to compounding, and the supply of Schedule 4D and Schedule 8 drugs, the National Law provides, as is set out above, for the alteration or removal of the conditions either under s 150A, where there has been a change in the practitioner's circumstances, or at any time under s 150C.
It thus seems to me to be open to the Applicant to urgently address the concerns, which appears not to have happened, and then to seek to have the conditions, or any one of them, altered or removed by the means available under those provisions whilst the health and safety of the public remains adequately protected. This is a factor weighing against a stay.

Conclusion

Having considered all the matters raised in respect of the balance of convenience I conclude that the balance does not favour a stay.
In my view, the grounds of appeal, to the extent that they raise points of law, are overall not such as to add much strength to favour a balance of convenience. If anything the position is to the contrary.
Secondly, the submissions and grounds relied upon by the Applicant in support of the stay do not provide me with confidence that there would be in place real and practical measures which would on an interim basis overcome the significant concerns which the Council had leading to the imposition of the conditions. I recognise that there might be some uncertainty in relation to how Conditions 4 and 5 operate but in the absence of identifying strongly arguable points of law in relation to those conditions I find it difficult to conclude that those uncertainties should lead to a position where a stay should be granted.
Overall, I consider that the paramount consideration, the protection of the health and safety of the public must prevail. I do not regard this application as justifying a stay in the interest of justice.
For the reasons outlined above I am prepared to grant a stay until the final determination of the appeal made pursuant to s 159B of the National Law in relation to the operation of Conditions 4(a) and 5(a) and in respect of the word "possess" in Conditions 4 and 5. The application should otherwise be dismissed.
I also note that by consent, the parties have agreed to a continuation of order 5 made by the Tribunal on 28 October 2022 until 14 days after the determination of this application for a stay.

Orders 1. Pending further order, and until the disposition of the s 159B appeal the subject of the application of 24 October 2022, there be a stay in relation to the operation of Conditions 4(a) and 5(a) of the conditions imposed on the registration of the Applicant's entitlement to practise as a pharmacist made on 21 October 2022 and in respect of the word "possess" in Conditions 4 and 5. The application be otherwise dismissed. 2. The costs of the stay application are reserved for determination in the appeal proceedings.

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: 24 November 2022

The Act

An appeal by a health practitioner who is the subject of action taken by the Council under s 150 is confined to an appeal "with respect to a point of law" to the Tribunal. The power to grant a stay of the Council's Decision pursuant to s 150 is set out in s 165L(2) of the National Law as follows: The Tribunal may, in respect of an appeal under s 159B, make an order staying the decision of the Council appealed against until the appeal has been disposed of.
The parties each relied on previous decisions of the Tribunal which set out the relevant principles and factors to be taken into account in the granting of a stay, namely Segal v Medical Council of New South Wales [2020] NSWCATOD 86 at [43]-[57], Mapa v Medical Council of New South Wales [2021] NSWCATOD 159 at [33]; Taylor v Medical Board of Australia [2018] NSWCATOD 50 at [10]-[11]; and also the observations by her Honour Judge Boland in Hanna v Pharmacy Council of New South Wales (No 2) [2021] NSWCATOD 181 where her Honour provided that the "additional important consideration in determining a stay in an application such as the present one, namely, that the protection of the health and safety of the public is a significant matter to be taken into account".
In Mapa v Medical Council of New South Wales [2021] NSWCATOD 159 Cole J explained: The principles to be applied when considering the merits of an application under s 165L(2) of the National Law for a stay of a Council's decision pending the final disposal of the appeal under s 159B of the National Law are set out in Ansari v Medical Council of New South Wales [2021] NSWCATOD 138, Hill v Medical Council of New South Wales [2019] NSWCATOD 52 and Liu v Chinese Medicine Council of New South Wales [2019] NSWCATOD 13. They are: (1) The onus is on an applicant for a stay to make out a case that it is appropriate to make such an order. (2) An order staying the operation of a decision or orders will generally be appropriate where such an order is reasonably necessary to secure the effectiveness of the appeal. (3) The Tribunal may take into account the strength or otherwise of the case of the party seeking the stay. (4) The Tribunal's power to grant a stay includes a power to make such an order subject to such conditions as the Tribunal specifies. (5) In exercising the discretion the Tribunal will weigh the balance of convenience and the competing rights of the parties and may impose appropriate conditions so as to achieve a result that is fair to all parties. (6) The overriding principle in an application for a stay is to ask what the interests of justice require.
It is of course well settled that each case must turn on its own specific facts and the Applicant bears the onus of establishing that it is appropriate to grant the stay (Taylor v Medical Board of Australia at [59]).
A stay, accordingly, is only available in respect of an appeal based on s 159B of the National Law which is limited to appeals with respect to a point of law (see Medical Council of NSW v Lee [2017] NSWCA 282 at [13]-[14], [93] and [96]). This limitation is important in the present matter. The identification of a point, or points, of law, assessed as to relative strength or weakness, together with, and as part of, the balance of convenience is central to the outcome.

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Cases Cited (19)