Kollias v Pharmacy Council of New South Wales

Two competing interpretations

1. The parties in Segal put forward two competing interpretations of s 165L(1) of the National Law as it applies to s 165L(2). The Medical Council submitted that s 165L(1) gives the Tribunal power to make any of the kinds of interlocutory orders listed in s 149A(b)-(f) in appeal proceedings under s 159B of the National Law including in proceedings for a stay of the decision appealed against. On this interpretation, the Tribunal not only has power under s 165L(2) to make an interlocutory order staying the decision appealed against, but it also has power under s 165L(1) to make any one or more separate interlocutory orders listed in s 149A(b)-(f). I will call this interpretation the "first interpretation."
2. The second interpretation is that the interlocutory orders referred to in s 165L(1) of the National Law are not available to the Tribunal when determining an application for a stay under s 165L(2). Section 165L(2) gives the Tribunal power to stay the decision, not the power to stay the decision on certain terms or conditions, including conditions on a practitioner's registration. I will call this interpretation the "second interpretation".

Natural and ordinary meaning

1. In support of the first interpretation, the natural and ordinary meaning of the phrase "during any proceedings under this law" in s 165L(1) of the National Law is during any proceedings whatsoever under the National Law. A "proceeding means a legal or other action or proceeding": National Law, Sch 7, Pt 3, cl 12. There are no qualifying words restricting the kinds of proceedings to which s 165L(1) applies. I note that the power to suspend a registered health practitioner's registration in s 165L(3) only applies to proceedings involving complaints against practitioners, not to appeals by practitioners.
2. In support of the "second interpretation", s 165L(2) does not, on its face, permit the granting of a stay on terms or conditions. The Tribunal has the power to stay the decision of the Council or not to stay the decision. The language of s 165L(2) may be contrasted with the language in s 43(3) of the Civil and Administrative Tribunal Act 2013 (NSW) which provides that the Tribunal "may make a such orders (whether with or without conditions) staying or otherwise affecting the operation of a decision ...". (That provision does not apply to proceedings under the National Law: Medical Council of New South Wales v Lee [2017] NSWCA 282.)
3. The fact that the Tribunal has no express power to stay a decision subject to conditions does not detract from the argument that there is the Tribunal may exercise the additional interlocutory powers identified in the s 165L(1) of the National Law. Any conditions on the practitioner's registration imposed by the Tribunal under s 165L(1) would be a separate interlocutory order. The order granting a stay would not be subject to conditions.
4. On balance, the natural and ordinary meaning of the words supports the first interpretation.

Context

1. The context also supports the first interpretation. Section 165L is in Part 8, Division 10, Subdivision 4 of the National Law. Part 8 is headed "Health, performance and conduct", Division 10 is headed "Constitution and proceedings of Tribunal" and Subdivision 4 is headed "Inquires and appeals before Tribunal (NSW)". The headings to Parts, Divisions and Subdivisions are part of the National Law: National Law, Schedule 7, clause 4(1). Those headings support the conclusion that the "proceedings" referred to in s 165L(1) means inquiries and appeals including an appeal under s 159B of the National Law and a stay application in such proceedings.

Appellate authorities

1. The first interpretation is not inconsistent with appellate authorities. In Segal, a submission was made that the first interpretation does not accord with the statutory scheme as explained by Sackville AJA in Medical Council of New South Wales v Lee [2017] NSWCA 282. The case involved a merits appeal under s 159 of the National Law, not an appeal "with respect to a point of law" under s 159B. The Tribunal has no power to stay the Council's decision pending the disposal of such an appeal. Sackville AJA noted at [90] that "... the Tribunal is expressly empowered on an appeal on a point of law to stay the decision (s 165L(2))." The question as to whether the Tribunal has other interlocutory powers on a stay application did not arise.

Legislative history and purpose

1. In Medical Council of New South Wales v Lee [2017] NSWCA 282 at [80]-[84], the Court set out the relevant legislative history of various provisions including s 150, s 150A, s 159B(1) and s 165L(2) of the National Law. Those provisions were introduced by the Medical Practice Amendment Act 2008 (NSW) which amended the then governing legislation, the Medical Practice Act 1992 (NSW). Sackville AJA noted at [81] that: ... the amendments were prompted by concerns about poorly performing or dangerous medical practitioners who were permitted to continue to practise for lengthy periods before any proceedings relating to their conduct came to the Medical Tribunal for determination.
2. In determining which of the two competing interpretations is correct, an interpretation that will best achieve the purpose or object of the National Law is to be preferred. Under cl 7 of Schedule 7 of the National Law: 7 Interpretation best achieving Law's purpose (1) In the interpretation of a provision of this Law, the interpretation that will best achieve the purpose or object of this Law is to be preferred to any other interpretation. (2) Subclause (1) applies whether or not the purpose is expressly stated in this Law.
3. The "main guiding principle" of the national registration and accreditation scheme is that the "protection of the health and safety of the public" is the "paramount consideration": National Law, s 3A.
4. The first interpretation best achieves the main guiding principle of the national registration and accreditation scheme. That interpretation allows the Tribunal, when determining whether to stay the decision of the Council, to also make a range of interlocutory orders to give effect to the paramount consideration - the protection of the health and safety of the public. Depending on the circumstance, the Tribunal could, for example, stay a suspension decision and make a separate interlocutory order imposing conditions it considers appropriate on the practitioner's registration.

Power to suspend

1. The Council's power to suspend a person's registration is conferred by s 150 of the National Law: 150 Suspension or conditions of registration to protect public [NSW] A Council must, if at any time it is satisfied it is appropriate to do so for the protection of the health or safety of any person or persons (whether or not a particular person or persons) or if satisfied the action is otherwise in the public interest - (a) by order suspend a registered health practitioner's or student's registration; or (b) by order impose on a registered health practitioner's registration the conditions relating to the practitioner's practising the health profession the Council considers appropriate; or ... (6) A Council must give written notice of action taken under this section to the registered health practitioner or student concerned.
2. On 16 February 2024, the Medical Council provided written reasons for suspending Mr Kollias's registration.
3. Brereton JA articulated the Tribunal's task under s 150 in Kirby v Dental Council of NSW [2020] NSWCA 91 at [15]. The issue for the Council "is not whether the allegations are proved, but whether the evidence establishes a risk to the public requiring suspension, or imposition of a condition, for protection of the public."
4. In Steel v Medical Council of NSW [2020] NSWCATOD 77 at [115], Boland ADCJ discussed the evaluative task of the Medical Council in s 150 proceedings and concluded that: I am satisfied that the task with which delegates are entrusted under s 150(1) is an "evaluative" risk assessment based on the evidence before them which must be focussed entirely on whether they are satisfied it is appropriate to protect the public or otherwise in the public interest to suspend or impose conditions on a practitioner's registration.

Earlier orders by Pharmacy Regulatory Unit (PRU)

1. On 7 December 2023, after reviewing a report of an investigation conducted by the PRU a delegate of the Secretary, NSW Health made two orders.
2. The first order prohibited Mr Kollias from "supplying or having possession of, or manufacturing any preparation, admixture or extract of a drug of addiction …" The ground for that order was that Mr Kollias was "a person whose authorisation to do that thing should be withdrawn for the purpose of protecting the life, or the physical or mental health, of that or any other person (whether or not any other such person is identifiable)": Poisons and Therapeutic Goods Regulation 2008 (NSW), cl 175(2)(d).
3. The second order prohibited Mr Kollias from having possession of or supplying the restricted substance cannabidiol on the same ground: Poisons and Therapeutic Goods Act 1966 (NSW), s 18AA(2) and s 18AA(3)(d).

The allegations

1. The first PRU report found that Mr Kollias was responsible for numerous breaches of the Poisons and Therapeutic Goods Act 1966 and the Poisons and Therapeutic Goods Regulation 2008 (NSW). In the reasons for decision the Council focused on four areas: that large amounts of S8 medicines remain unaccounted for; deficiencies in Mr Kollias's storage and record keeping of S8 medicines; dispensing on invalid prescriptions and concerning patterns of cannabis dispensing.

Large amounts of S8 medicines remain unaccounted for

1. There were significant discrepancies between the physical stock on hand and the balance recorded in the register. Under the heading "Introduction" in the Council's decision, the nature of the risk to health and safety was identified: At the time of the hearing and due to the gravity of non-compliance, large amounts of S8 medicines might remain unaccounted for. The unknown fate of those medicines, combined with the potential for misappropriation, led the Council to conclude that if Mr Kollias continued to be registered there was an unacceptable risk to public health and safety.
2. The Council went on to note that: In his written submissions Mr Kollias states that he takes "full responsibility for the discrepancies between physical stock on hand and the balance recorded in the S8 drug register". He acknowledges that entries in the drug register must be made on the day of dispensing and "deeply regrets that this was not the case."
3. Mr Kollias stated in his written submissions to the Council that the number of S8 medications identified in the PRU Report as being unaccounted for is incorrect. However, he acknowledged that he had failed to comply with several legislative requirements for the storage, management and record-keeping of S8 medicines.
4. The Council was concerned about the possibility that the drugs had been diverted. Mr Kollias states in his submission that the large amount of S8 medicines which were unaccounted for at the time of the PRU inspection raises a "prima facie concern about diversion". We absolutely agree with Mr Kollias about this concern and that he appreciates the seriousness of this issue.

Other deficiencies in storage and record keeping

1. The Council found that: S8 medicines were stored in areas other than a safe; entries into the S8 register were not made on the day the S8 medicines were received and/or supplied; biannual stock counts of all S8 medicines had not been conducted; and pharmacists failed to record the name of the prescriber when supplying S8 medicines on prescription.

Dispensing on invalid prescriptions

1. In three respects, the Council found that S8 and S4B medicines were supplied on invalid prescriptions. Firstly, S8 medicines were supplied on non-compliant prescriptions. Secondly, unregistered S8 medicines were supplied on faxed prescriptions prior to the receipt of the original prescriptions. Thirdly, S4B medicines were supplied on multiple occasions from the same prescription where the prescription did not specify a repeat interval.
2. Mr Kollias acknowledged several examples of S8 medicines being supplied on non-compliant prescriptions but considered these to be "restricted incidences that do not reflect the high standard of care" that he strives for.

Concerning patterns of cannabis dispensing

1. The Council found that for 12 months after 2 November 2022, unapproved cannabis medicines made up approximately 32% of all prescriptions dispensed at the Pharmacy, equating to approximately 31,600 scripts.
2. The PRU selected five patients for in depth analysis. The Council questioned Mr Kollias about these patients at the s 150 hearing. The Council expressed great concern that Mr Kollias had not kept detailed notes of his discussions with prescribers. The Council could not understand some of Mr Kollias's explanations about the patterns of cannabis dispensing. The Council concluded that Mr Kollias had failed to exercise his professional judgment and autonomy when dispensing large quantities and combinations of cannabis medicines to individual patients.

Remedial action

1. Mr Kollias did not seek to rebut the findings of the first PRU report but wished to describe the remedial actions he had implemented to address the deficiencies. The Council considered whether Mr Kollias had implemented remedial action to eliminate the risk that his practise, knowledge and understanding pose a risk to the health and safety of the public.
2. The Council acknowledged that, to his credit, Mr Kollias had employed some new pharmacists, one of whom had specific knowledge in cannabis medicines dispensing. He had also engaged the services of a mentor pharmacist.
3. The Council concluded that Mr Kollias had failed to persuade them that he had improved deficiencies in record-keeping of S8 and S4 medicines, procedures within the pharmacy or his personal dispensing practice of cannabis medicine. The Council's concerns about diversion of cannabis were heightened during the hearing when it was revealed that 171 cannabis products were still not accounted for. Whether or not this was the correct amount, the Council considered that Mr Kollias had had a reasonable time to reconcile these differences but had not done so. The Council formed the view that there was a high risk that these products had been diverted, possibly posing serious risks to the health and safety of the public.
4. The Council was not reassured by Mr Kollias's claim that he had developed new Standard Operating Procedures (SOPs). He did not provide copies of any SOPs to the Council because of unidentified "proprietary interests." Mr Kollias could not explain to the Council how the SOPs had been communicated and implemented.
5. As for recent enrolment in CPD courses, the Council was not confident that Mr Kollias understands the importance of updating his knowledge of pharmacy practice at the time he needs it.
6. Of significant concern to the Council was that even during the hearing Mr Kollias failed to appreciate the significance of "red flags" displayed by several of his patients. He considered that as long as he confirmed the prescription with an interstate telehealth prescriber, that was sufficient to alleviate any concerns he might have about drug dose, titration, mixing of cannabis medicines and quantity and purpose of supply. He did not believe that consulting with a pain specialist or a psychiatrist was a worthwhile additional source of information. The Council concluded that Mr Kollias had no intention of changing his practices.

Council's conclusion

1. The Council was not persuaded that the remedial actions purportedly undertaken by Mr Kollias were sufficient to remove the identified risks. In the Council's view, Mr Kollias failed to meet the responsibilities he has as a pharmacist. He exhibited unsatisfactory knowledge, care and judgement. In the Council's view, there were no conditions that could be imposed on his registration that would sufficiently mitigate the identified risks to the health or safety of the public. The Council considered suspension to be necessary for two reasons: to protect the health and safety of any person or persons and because it was otherwise in the public interest: National Law, s 150.

Second PRU report

1. The trigger for the Council's suspension decision under s 150 of the National Law was the first PRU report dated 4 December 2023. The PRU finalised a second report on 26 February 2024. The second PRU report concluded that despite orders served on Mr Kollias on 8 December 2023 prohibiting him from supplying and possessing S8 medicines and S4 cannabidiol in NSW, it is evident that non-compliance with the provisions of the Poisons and Therapeutic Goods Act and the Regulation by pharmacists at the pharmacy, including Mr Kollias, had continued.
2. The Council tendered that report in evidence on the basis that it was relevant to two issues. First, the Tribunal could have no confidence that Mr Kollias would comply with any conditions the Council may impose on his registration if the stay is granted. Secondly, Mr Kollias has not taken appropriate remedial action to address the issues raised in the Council's s 150 decision.
3. The report was not before the Council when it made its decision at the end of January 2024 and Mr Kollias has not had an opportunity to be heard in relation to the findings contained in the report.
4. Given those factors, I accept the report for the limited purpose of supporting the Council's finding, when making the s 150 decision, that Mr Kollias has not taken appropriate remedial action to address the issues raised in the first PRU Report.

Grounds of appeal

1. The demonstration of an arguable appeal is a condition precedent to obtaining a stay. The Notice of Appeal sets out the following grounds of appeal: Pursuant to s 159B of the National Law the respondent misapplied the statutory test in s 150 of the National Law when determining to suspend his registration and made a decision based upon information that the appellant was not given the opportunity to meet.
2. That ground of appeal was not relied on in written submissions on the stay application or in oral submissions. As no submissions were made in support of that ground, it has little prospects of success.

Wednesbury unreasonableness

1. In the written submissions Mr Kollias relied on another ground of appeal, "Wednesbury" unreasonableness. Mr Kollias submits that the first limb of Wednesbury unreasonableness focuses on the decision-making process - whether the right matters have been taken into account in reaching the decision; while the second limb focuses upon its outcome - whether even though the right things have been taken into account, the result is so outrageous that no reasonable decision maker could have reached it.
2. Mr Kollias submits that the Council placed too much emphasis on the complaint and the PRU report, and insufficient emphasis on his challenge to material aspects of the alleged conduct, insight into the complaint, conduct since the complaint and preparedness to further improve. That appeal ground was not developed in oral submissions at the stay hearing. In my view it has little prospects of success.

Inadequate reasons and failure to take into account a material fact

1. In oral submissions, Mr Kollias put forward two other grounds of appeal. The first was that the Council had failed to provide proper reasons for the decision. The second ground was that the Council had failed to take into account a material fact, namely that Mr Kollias was already subject to the PRU's prohibition orders. These grounds were raised for the first time at the hearing but we understand that these will be the grounds on which Mr Kollias will rely at the substantive hearing.

Failure to provide proper reasons

1. Mr Kollias submits that in their reasons the Council failed to identify the precise risk to public health and safety on 22 January 2024, if Mr Kollias were permitted to continue practising pharmacy.
2. At [56] the Council decided that the imposition of conditions would not adequately address the Council's concerns about the risks to health and safety if Mr Kollias's registration continued: Given the significant evidence of deficiencies in Mr Kollias's standard of practice, knowledge and understanding uncovered during the PRU investigation, particularly in relation to the storage, management and dispensing of cannabis medicines and the inability of Mr Kollias to provide reassurance that he had implemented remedial actions to address these deficiencies, we are of the opinion that imposing conditions on Mr Kollias's registration will not mitigate the risks to the health or safety of the public, or mitigate concerns regarding the public interest.
3. According to Mr Kollias, the Council did not explain why the existing prohibition orders imposed by the PRU, together with appropriate conditions, was inadequate to address any risk to health and safety and the public interest considerations.
4. The Council did not articulate their reasoning process in that part of the decision when conditions were being considered. But the reasoning process can be gleaned from a fair reading of the decision as a whole.
5. When determining whether it was appropriate to impose conditions on Mr Kollias's registration, the Council referred, in a general sense, to concerns about the storage, management and dispensing of cannabis medicines and Mr Kollias's failure to remedy these deficiencies. In that paragraph, the Council did not identify the precise risk to the health and safety of the public or the public interest if Mr Kollias is subject to conditions prohibiting him from possessing, supplying or manufacturing drugs of addiction and cannabidiol.
6. However, a fair reading of the decision as a whole reveals that Council had two main concerns. The first was the concern about continuing misappropriation or diversion of cannabis product. The second was that Mr Kollias had not adequately remedied the identified deficiencies in his practice.
7. On the first page of the decision under the heading "Introduction". The Council pointed out that "large amounts of S8 medicines might remain unaccounted for" and that Mr Kollias had had a reasonable time to reconcile these differences but had not done so. The Council went on to state that its concerns about diversion were heightened during the hearing when it was revealed that 171 cannabis products were still not accounted for. Mr Kollias disputed this amount but agreed that the discrepancies raise a "prima facie concern about diversion".
8. The potential for misappropriation or diversion led the Council to conclude that if Mr Kollias continued to be registered there was an unacceptable risk to public health and safety. Although not articulated, I understand the Council's reasoning to be that if the discrepancies are not merely recording errors, someone who had access to the unaccounted for cannabis products, including Mr Kollias, had consumed the products, given the products to someone else or sold the products illegally. As long as Mr Kollias was unable to account for what the discrepancies, there was a risk that cannabis had been, and could continue to be, misappropriated or diverted.
9. Council also expressed "great concern" that Mr Kollias had not kept detailed notes of his discussions with prescribers and had dispensed large quantities and combinations of cannabis medicines to individual patients. I have inferred from the decision, that one reason the Council was not confident that the imposition of conditions would address their concerns, was that Mr Kollias had not taken appropriate remedial action to address the issues it had identified.
10. Council could have articulated its reasoning process in more detail when considering whether to impose conditions on Mr Kollias's registration. However, when the decision is read as a whole, the nature of the risk is apparent. An appeal on the ground of inadequate reasons has little prospects of success.

Failure to take into account a material fact

1. The so-called "material fact" was that when the Council decided to suspend Mr Kollias's registration he was already subject to the PRU's prohibition orders. The effect of those orders was that he could not possess or dispense drugs of addiction or cannabidiol. Therefore, there could be no risk associated with him doing so.
2. Mr Kollias referred to the decision of Pridgeon v Medical Council of New South Wales [2022] NSWCA 60 at [70] where the Court of Appeal held at that: "… the context of s 150 suggests that it should only be invoked as an emergency power where the circumstances are urgent." Mr Kollias submitted that the circumstances were not urgent because he was already subject to the PRU's prohibition orders and the Council could have imposed further appropriate conditions.
3. The Council did not refer to the PRU orders to which Mr Kollias was subject, but did consider whether any conditions to similar effect should be placed on his registration. For the same reasons I have given in relation to the "failure to provide proper reasons" ground of appeal, An appeal on this ground has little prospects of success.

Taking into account historical matters rather than assessing risk as at the day of the hearing

1. Mr Kollias highlighted parts of the Council's decision which spoke of his past experience. At [39] of the reasons, in response to Mr Kollias having participated in various continuing professional development (CPD) courses, the Council wrote: This seems to us to be far too late. An understanding of these very fundamental aspects of cannabis dispensing should have been part of his working knowledge for the two years that he and others at the Pharmacy have been dispensing cannabis medicines.
2. At [40] the Council concluded that Mr Kollias's failed to exercise professional judgment and autonomy when dispensing large quantities and combinations of cannabis medicines to individual patients. This was an area where his professional practice, knowledge and understanding posed a risk to the health and safety of the public.
3. At [49] the Council commented again on Mr Kollias's recent enrolment in CPD courses focusing on the dispensing of cannabis medicines. The Council expressed the view that they were "surprised and disappointed that Mr Kollias had not considered it imperative to acquire that knowledge as soon as his pharmacy commenced dispensing cannabis medicines."
4. At [51] the Council concluded that "… the dispensing practices adopted by Mr Kollias puts both his patients and the public at significant risk". According to Mr Kollias the use of the word "puts" in this sentence suggests that Council found that there was such a risk as at the date of the hearing on 22 January 2024. Mr Kollias submits that there could be no risk at that time because he was subject to the prohibition orders imposed by the PRU.
5. We understand the gist of this ground to be "taking into account immaterial facts" that is, facts about Mr Kollias's background or experience which are not relevant to an assessment of the risk to public health and safety when the s 150 hearing took place. The Council should have focused on the present circumstances.
6. This ground was not put as a ground of appeal with respect to a point of law. I cannot identify a point of law raised by these submissions and it follows that it has little prospects of success.

Balance of convenience and competing rights of the parties

1. A stay may be granted on terms that are fair to all parties. That involves weighing the balance of convenience and the competing rights of the parties. Relevant factors include the prejudice to the parties and whether the hearing can be expedited. The overriding question is what the interests of justice require.
2. Mr Kollias had a financial interest in a pharmacy immediately before his registration was suspended. Under clause 5(2)(c) of the Schedule 5F to the National Law, he can continue having a financial interest for up to 6 months after suspension of his registration. If the suspension order remains in place after 22 July 2024 (6 months after suspension) Mr Kollias would be compelled to relinquish his financial interest.
3. However, under Clause 5(3) of Schedule 5F, a person may have a financial interest in a pharmacy business as long as the business is in the charge of a pharmacist who personally supervised the carrying out of that business. I understand that to be the case in relation to the pharmacies in which Mr Kollias has a financial interest. If that is correct, there is no risk that Mr Kollias will be compelled to relinquish his financial interest.
4. The appeal under s 159B of the National Law has been expedited and is listed for hearing on 14 June 2024. Any risk of Mr Kollias subsequently losing his financial interest in the pharmacy can be addressed at that hearing.

Conclusion

1. For the reasons I have given, the grounds of appeal are barely arguable and the balance of convenience is in the Council's favour.

Orders 1. The application for a stay of the decision to suspend Mr Kollias's registration as a pharmacist is refused. 2. The costs of the stay application are reserved.

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: 12 April 2024