Sadri v Pharmacy Council of New South Wales

NCAT Occupational|2024-08-19

reasons for decision

On 20 May 2024, delegates of the Pharmacy Council of New South Wales ("the Council") issued an order under s 150(1)(a) of the Health Practitioner Regulation National Law (NSW) ("the National Law") suspending the registration of Ms Negina Sadri ("the Appellant"), a registered health practitioner, a pharmacist, with effect from 21 May 2024.
Written reasons for the decision of the Council delegates to do so were published on 11 June 2024 ("the Decision").
On 11 June 2024, the delegates of the Council also referred the matter before them to be dealt with as a complaint for investigation pursuant to s 150D of the National Law.
The s 150 proceedings came about as a result of the Council receiving a complaint on 2 May 2024 from the Pharmaceutical Services Unit ("PSU") that identified concerns about several major areas of non-compliance in the Priceline Pharmacy Blacktown ("the Pharmacy") of which the Appellant is currently the proprietor.
The PSU is part of the legal and regulatory services branch of the New South Wales Ministry of Health and is responsible for administration and enforcement of the Poisons and Therapeutic Goods Act 1996 and the Poisons and Therapeutics Goods Regulation 2008 ("PTGR").
An urgent hearing before the delegates of the Council was held on 20 May 2024.
On 26 June 2024, the Appellant made an external appeal to the Tribunal challenging the Decision pursuant to s 159B of the National Law which provides for an appeal, with respect to a point of law, to the Tribunal by a registered health practitioner who is the subject of action by the Council under s 150 of the National Law.

Relevant Legal Principles: s 150

In Medical Council of New South Wales v Smithson [2021] NSWCA 53 at [20] the Court of Appeal set out the relevant principles in respect of an appeal under s 159 of the National Law in the course of which the meaning and effect of s 150 was set out as follows at [20] (per Payne JA, Simpson AJA and Garling J): "20. As error has been conceded it is appropriate first to set out the principles applicable to the determination of an appeal under s 159. Those principles have been extensively discussed in recent decisions of this Court in Ghosh v Medical Council of New South Wales (2020) 102 NSWLR 303; [2020] NSWCA 122 and Kirby v Dental Council of NSW [2020] NSWCA 91. The most important are: (1) The role of the Tribunal in a s 159 appeal of the present kind is to apply s 150 standing in the shoes of the Council. The hearing is de novo and not limited to evidence before the Council. The legal standard to be applied is fixed by s 150: Kirby at [117]-[119]; Ghosh at [9]. (2) The subject matter, scope and purpose of s 150 makes clear that it is a protective provision with two independent limbs. The touchstone for the exercise of the Council's role under s 150(1) to make an order suspending the practitioner's registration or imposing conditions on it is that the Council be satisfied that it is appropriate to do so for (i) the protection of the health or safety of any person or persons (the first limb), or (ii) that the action is otherwise in the public interest (the second limb): Kirby at [15]; Ghosh at [5]. The two limbs may overlap but the public interest is not subsumed in the first limb: see Pharmacy Council of NSW v Ibrahim [2020] NSWSC 708 at [35]. The two limbs are disjunctive; satisfaction of either will suffice to trigger the obligation imposed by s 150. (3) The proceedings are not disciplinary and are not necessarily referable to a complaint. The National Law otherwise makes provision for dealing with complaints against registered health practitioners: see Div 3 Subdivs 2-6. The function of a s 150 hearing is purely protective in character: Kirby at [15]; Ghosh at [5]. By s 150D, a Council must, after taking action under s 150(1) (except in the case of impairment), refer the matter to the Health Care Complaints Commission ("HCCC") to be investigated as a complaint. By s 150F, in a case of impairment, the Council must consult with the HCCC to see if agreement can be reached as to whether the matter should be dealt with as a complaint or referred to an Impaired Registrants Panel: Ghosh at [3]. … (7) The "protection of the health and safety of any person or persons" does not require there be actual harm suffered by any person. Because s 150 is concerned with protection, it is sufficient if it can be demonstrated that there is a potential for harm: Ghosh at [9]. The Tribunal's role in this case was to make an assessment of the evidence and determine whether it was appropriate, on either of the bases for which s 150 provides, that an order be made under s 150 for the protection of the health or safety of any person or persons or otherwise in the public interest. (8) 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. (9) The essential question which the proper conduct of a s 159 hearing de novo requires the Tribunal to address is whether allowing the medical professional to practise, or to practise with certain conditions, involves an unacceptable risk to the health and safety of the public, or otherwise involves an unacceptable risk to the public interest: Ghosh at [103]."
Although the principles set out there were addressed to the Tribunal's role under an appeal pursuant to s 159 they are relevant, in my view, since in the de novo appeal under s 159 the Tribunal stands in the shoes of the relevant Council. The principles are thus germane to the role of the Council under s 150.
In Karimi v Medical Council of New South Wales [2017] NSWCATOD 180 at [123] the Tribunal set out the approach required of the Tribunal on an appeal under s 159 which also considered the scope of s 150(1) as follows: "(1) Nature of the appeal The Tribunal is to conduct the appeal by way of a new hearing and may consider evidence that was not before the Council as the original decision-maker. The Tribunal's task is not to review the decision of the Council and determine whether its decision was reasonably open in the circumstances. The Tribunal is called on to exercise afresh the administrative discretion in s 150(1) having regard to the material before it. (s 159(3) of the National Law and Hanna at [17]-[18]) (2) Protective jurisdiction The jurisdiction being exercised is directed to the immediate action that may need to be taken in order to protect the health or safety of any person or persons or the public interest. (ss 3A and 150 of the National Law, Hanna at [17] and Crickitt at [47]) (3) Consequences of suspension The exercise of the power to suspend can be described as "draconian" and will have grave consequences for a practitioner, affecting not only the ability to earn a livelihood, but also the continuing ability to use his or her professional skills. Nevertheless, this is but a consequence of any appropriate exercise of discretion, and not a determining factor. (Crickitt at [56]; see also X v NSW Medical Board (1993) 32 ALD 330 and Lindsay v NSW Medical Board [2008] NSWSC 40 at [80], which considered s 66 of Medical Practice Act 1992 (NSW), being the predecessor to s 150 of the National Law) (4) No need for a detailed enquiry The existence of the power, and the fact that it may be exercised without any formal complaint having been made against the practitioner, and without any disciplinary proceedings having been commenced, is indicative that the Tribunal need not embark upon a detailed enquiry, and may base its reasons on material which would not conventionally be considered as evidence in a strict sense as would be admissible in a court. (Crickitt at [56]; see also Lindsay at [76]) (5) Not required to make any conclusive findings Because the circumstances in which the power under s 150 is to be exercised include that there may be a continuing dispute as to precisely what occurred and why and that investigations into complaints concerning the practitioner by bodies such as the HCCC may not have been completed or even commenced, the Tribunal is not required to make conclusive findings of fact based on the material before it. (s 150 of the National Law and Hanna at [19]) (6) Pre-conditions on power to suspend The Tribunal must assess whether "it is appropriate for the protection of the health and safety of any person or persons" or "is otherwise in the public interest" to make such orders as are permitted by s 159C. The Tribunal's task is in essence to consider whether, on the material before it, allowing the practitioner to practice, or to practice with certain conditions, involves an unacceptable risk to the health and safety of the public (or particular members of the public) or otherwise involves a risk not in the public interest. (ss 150, 159 and 159C of the National Law and Hanna at [20]) (a) Scope of "protection of the health and safety of person or persons" The "protection of the health and safety of any person or persons" does not require there be actual harm suffered by any person. Because s 150 is concerned with protection, it is sufficient if it can be demonstrated that there is a potential for harm. This approach is fortified by the alternative test of a consideration of the public interest. It would be in the public interest to prevent harm being suffered by a person or persons if it could be predicated that this may occur. (Section 150 of the National Law and Crickitt at [48]) (b) Scope of "public interest" The "public interest" consideration will always also include the need for patients and others to have confidence in the competence of practitioners and that practitioners will exhibit traits consistent with the honourable practice of an honourable profession (ss 150 of the National Law, Hanna at [18] and Crickitt at [56]) (7) No need to determine whether conduct is "professional misconduct" or "unsatisfactory professional conduct" Apart from what is involved in assessing the risk referred to in the preceding subparagraphs, it is not otherwise necessary for the Tribunal to determine whether the conduct under notice constitutes "professional misconduct" or "unsatisfactory professional conduct" or to make findings as to the fitness of the practitioner to retain registration as a medical practitioner. Those are matters that may fall to be addressed at a later stage, if and when disciplinary proceedings are taken against the appellant. (s 150 of the National Law and Hanna at [22]) (8) Nature of suspension power under s 150 An order made under s 150, including a suspension order, is in the nature of an interlocutory order and often must be made on the basis of limited information. (s 150 of the National Law and Crickitt at [51] and the authorities cited there; Lindsay at [79]) (9) Council's separate power to reconsider suspension A practitioner may also apply directly to the Council for a review of a s 150 decision to suspend a practitioner's registration. If satisfied there has been a sufficient change in the practitioner's circumstances, the Council can affirm or vary the decision or set it aside and take any action it has power to take under s 150. (s 150A(2)(b) and (3) of the National Law)."
It is thus necessary for the Appellant to establish that the Council in the exercise of the s 150 power, as interpreted in the cases referred to above, erred with respect to a point of law.

PSU Report

The PSU Report provides a detailed account of an inspection which occurred at the Pharmacy following a complaint received on 13 March 2024 which alerted the PSU to a number of issues which required investigation.
The PSU Report provides a summary of findings as follows: "A. Keys to the drug safe were kept in a drawer in the dispensary, contrary to clause 76 of the PTGR. B. The Schedule 8 drug tapentadol was supplied on a prescription that did not contain a patient's address. The person "HD" who was attributed to this dispensing is a dispensary technician, not a registered pharmacist, contrary to clause 85 of the PTGR. C. Dispensary technicians were attributed to the dispensing of Schedule 4 and Schedule 8 drugs in the dispensing records, contrary to clause 55 and clause 113 of the PTGR. D. Bundles of dispensing labels and repeats of high-cost PBS drugs were found in a drawer in the dispensary where it is indicative that dispensing had occurred, but there were no records of supply observed from your FRED dispensing system and there were no purchase records of these medicines from the wholesale suppliers API and Sigma, in contravention of clause 55, 176 and 177 of the PTGR. E. Pharmacists had made alterations to the records in the methadone drug register and subsidiary drug register, contrary to clause 177 of the PTGR. F. Pharmacist's signatures were missing from the methadone drug register records, in breach of clause 112 of the PTGR. G. More methadone takeaway doses had been supplied to a patient, contrary to the directions on the prescription and clause 85 of the PTGR. H. The methadone takeaway dispensing label did not meet the requirements of section 5.2.7 of TG201/6. I. Multiple prescriptions were observed in the patient's file. Some superseded or expired prescriptions issued for ODT has not been marked "CANCELLED", contrary to clause 88 of the PTGR. J. The non-receipt of original copy of methadone prescription issued for Troy Weyland had not been reported to PSU, in contravention of clause 96 of the PTGR. K. The original copy of signed receipt of Schedule 8 drugs had not been returned to the wholesaler API as required by the provisions of clause 95 of the PTGR. L. A prescription for a Schedule 4 drug was stored with the prescriptions of Schedule 8 drugs, in contravention of clause 89 of the PTGR. M. Staff who are not pharmacist have keys to the pharmacy."
The PSU Report then sets out in much greater detail the evidence gathered leading to the summary of the 13 alleged failures on the part of the Appellant to comply with her obligations as a registered pharmacist.
It will be seen from that summary that concerns are raised about conduct contrary to 11 clauses of the PTGR, namely, clauses 55, 75, 85, 88, 89, 95, 96, 112, 113, 176 and 177 and also clause 5.2.7 of the TG201/6. The reference to TG201 is to the New South Wales Opioid Treatment Program Community Pharmacy Dosing Point Protocol.

The Decision

The delegates of the Council identified the central issue for consideration to be whether it is appropriate to take action under s 150 of the National Law in respect of the Appellant for the protection of the safety or health of the public or otherwise in the public interest. The Decision records that the task under s 150 of the National Law involves a risk assessment having regard to the guiding principle in s 3A of the National Law that the protection of the health and safety of the public must be a paramount consideration.
The delegates then proceeded to consider the matter which they were obliged to consider by reason of s 41O of the National Law, namely whether there are previous complaints concerning the Appellant.
The delegates noted that there was a complaint in 2019 against the Appellant that resulted in a counselling session regarding conduct alleging that Schedule 8 (S8) medications were dispensed in exchange for prescriptions for different medications (diabetes and heart medications) and dispensing of PBS subsidised medications for free.
The next issue considered was whether the Appellant had the necessary standards of practice, knowledge and understanding so as to not pose a risk to the health or safety of the public. In relation to that issue, the Decision proceeded as follows: "16. When questioned, Ms Sadri was able to outline the responsibilities of a proprietor pharmacist, and explained that a proprietor is required to "oversee everything" including ensuring that policies and procedures are in place and that all staff follow these policies, procedures, and all relevant guidelines and regulations. 17. We asked her what she has done in her pharmacies to ensure that the non-compliance issues identified in the PSU report have been addressed. She explained that she has produced a table of the issues and worked through each issue with her staff. She has also asked her staff to sign documentation to confirm that they had understood the issues and the relevant clauses. 18. We note that at various times during the hearing Ms Sadri referred to existing or new policies and procedures that she has put in place in her pharmacies. She provided copies of a number of those documents following the hearing. The documents are labelled "new" or "old" (i.e. they were in place prior to the complaint or they have been introduced following the complaint). As indicated by Ms Sadri at the hearing, one of the documents is a list of relevant regulatory clauses with a column for staff to initial. It appears that only two or three employees have initialled this document. We note further that the date on the document is 17 May 2024, three days before the hearing. Given that the PSU inspection of the Pharmacy took place on 22 March 2024 and the Ms Sadri's interview with the PSU took place on 26 April 2024 we are concerned that Ms Sadri did not address the PSU concerns more urgently. We might reasonably conclude that Ms Sadri only created the initialled document after she received the notice of hearing (dated 9 May 2024). 19. We referred Ms Sadri to the "Summary of findings" in the PSU inspection report beginning at the bottom of page 3 and listed as items "A" through to "M". We asked Ms Sadri whether she disputed any of the concerns raised in A - M, excluding D (noting that we would return to D). Ms Sadri responded that she did not dispute the concerns and wished to explain how they have been addressed. Accordingly, we discussed points A - M (excluding D) in detail with Ms Sadri. There were a number of common themes in Ms Sadri's responses, which can be summarised as: • Ms Sadri blamed the employee pharmacists for either not understanding the regulations, not following the procedures in place or making a mistake • In a number of responses Ms Sadri referred to the concern as a "one-off" issue that won't happen again • Ms Sadri has put new procedures in place that ensure it won't happen again • Ms Sadri acknowledged a lack of proprietorial oversight, accepted responsibility and undertook to be more vigilant from now on. 20. We note that there were two exceptions to these common themes. … 23. The panel believes that Points A - M (excluding D) are of a different order to the concerns identified in Point D. Points A - M (excluding D) relate largely to proprietor oversight matters. From our discussions with Ms Sadri it was apparent that her knowledge and understanding of her responsibilities as a proprietor is generally adequate, with the exception of Point M, where she acknowledged that she was not aware of the regulation. The difficulty lies not with her knowledge and understanding but with her standard of practice as a proprietor. Ms Sadri correctly identified that she is responsible for the error made by her employee pharmacists. As the proprietor, she is responsible for not only ensuring that the correct policies and procedures are in place but also that her staff are trained in those policies and procedures. In addition, she has a responsibility to audit her pharmacies to ensure that her staff are actually carrying out those policies and procedures. It was clear to the panel that even where there were policies and procedures already in place, Ms Sadri had not adequately trained her staff and had not audited how well the policies were being implemented. 24. This failure is of particular concern given Ms Sadri's long history of complaints. We note in particular the 2019 complaint that resulted in a Council counselling session regarding conduct. The Council does not lightly require a practitioner to attend counselling. It is typically an opportunity for the Council to explain to the practitioner that the complaint against them has been accepted to have substance and that they need to improve the standard of their practice in order to minimise any further risk to the public. It appears that Ms Sadri may not have recognised the importance of the counselling process and it is a significant concern that she is before the Council again with such a serious complaint. 25. We then questioned Ms Sadri about Point D of the PSU report. Point D is a summary of the PSU concerns (see page 4) and their concerns are outlined in detail on page 7 and following. The heading of Point D states that: 26. "Bundles of dispensing labels, prescriptions and repeats were found in paper bags in a dispensary drawer. There were no records of supply observed from their FRED dispensing system and no purchase records from the major wholesaler suppliers, in contravention of clause 55, 176 and 177 of the PTGR." 27. On pages 10 and 11 of the report the PSU notes that they found a handwritten note within the bundles (attached to the PSU report as Appendix I). The note contained the names of nine patients, with a monetary amount written next to each name. The PSU report discusses in detail the three patients with highest value written next to their names and provides a summary of all nine patients in a table. 28. To be clear, the PSU report makes a serious allegation of PBS fraud against Ms Sadri. In doing so, the PSU refers to the similarity to the previous complaint that has been referred to another body (see pages 14 and 15). The panel understands that the PSU is alleging that there is deliberate intent to defraud the PBS. 29. High-cost medications are, by definition, expensive for a pharmacy to stock and consequently many pharmacies will keep a minimal level of stock on their shelves. Consequently, when a script is presented it may be necessary to order in the medication. When the script has been dispensed the cost to the pharmacy will be submitted to the PBS as part of the regular claim cycle for the cost of all PBS medications dispensed at that pharmacy. It is not unusual for there to be mistakes or prescription cancellations and where this is the case the pharmacy's dispensing software will communicate the cancellation to PBS Online and the relevant amount will be deducted from the next payment cycle to the pharmacy. Assuming that accurate records are maintained in that pharmacy, it is a relatively simple matter to trace the medication from the point that the pharmacy purchases it from the supplier, through dispensing to a patient and finally to a claim to the PBS. 30. The PSU is alleging that Ms Sadri has defrauded the PBS by making numerous claims to the PBS for high-cost medications that were not purchased by the Pharmacy and dispensed but not supplied to patients. The PSU alleges that this has occurred in collaboration with patients who are persuaded to attend a doctor to get a prescription for high-cost medications and then present that prescription to the Pharmacy. The medication is dispensed and payment from PBS is claimed but medication is not supplied to the patient. 31. Ms Sadri allegedly uses the prescriptions to claim the cost of the medications from the PBS. The patients are allegedly rewarded by being given 25 percent of the PBS payment to the Pharmacy, with Ms Sadri keeping the other 75 percent. The PSU estimates that the financial gain to the Pharmacy from 9 patients over 14 days was almost $65,000 and notes that there are many more examples that it was impractical to outline. 32. We questioned Ms Sadri about the patients (AD, EC, CR and RG) discussed in the PSU report (see pages 8 - 13). Of these, EC, CR and AG are listed in the handwritten note. 33. We asked for general comments first and Ms Sadri advised that the bundle found by the PSU contained deleted/cancelled scripts that should not have been left in a drawer. The medications were not supplied to the patients. Her understanding was that if the cost of the medication had been claimed from the PBS it would have been automatically deducted by the PBS when the scripts were cancelled. She also stated that all money received from these claims have been refunded to PBS. 34. We then asked why patient AD would have been dispensed 5 or 6 scripts on the same day, then had the scripts cancelled, with the labels then being left in a bag. Ms Sadri advised that when she questioned her staff about patient AD they recalled that he dropped in the scripts and asked for the whole quantity because he was going overseas. He then left and, after leaving his phone number, said he would return the next day. The dispensary technician dispensed the script and the repeats but then realised the medication was not in stock and put it aside for a special order. Ms Sadri explained that when the pharmacist saw the special order they realised the issues and tried to call the doctor and the patient multiple times. The medication was not ordered (noting it was very expensive) and the pharmacist waited for the patient to return. When the patient didn't return, the scripts were cancelled and put in "the cancelled bag". Ms Sadri did not provide any documentation to support this explanation, particularly as those scripts were not annotated by the prescriber as a Regulation 49 (formally known as Regulation 24) which would indicate that they could be dispensed all at once if the patient was to be travelling overseas. 35. Furthermore, the panel found this explanation unconvincing. It seems very odd that the patient was uncontactable and chose not to return to pick up the medication. 36. At the beginning of the hearing Ms Sadri had advised that she spent two days a week in the Pharmacy. We asked her how it was possible that she didn't notice the bag of cancelled scripts. She advised that at about that time she was going through a cancer scare, was not in the pharmacy for a couple of months during that time and didn't know the scripts were there. We note that Ms Sadri was adamant that she did not dispense the scripts but acknowledges that they were dispensed under her initials. She advised that she has put new procedures in place to ensure that her staff dispense under their own initials. 37. We asked Ms Sadri to explain the handwritten note. She advised that she has no idea what it was referring to and no idea what it means. She rejected the PSU allegation as absolutely false. She also advised that when she asked her staff they knew nothing about it. 38. We also found this explanation unconvincing. It is obviously not possible that her staff knew nothing about the handwritten note and it is inconceivable that Ms Sadri appears to have made no serious attempt to investigate why there was a note in her pharmacy with patient names associated with substantial monetary amounts. 39. Ms Sadri's explanation for the other three patients were also unconvincing. She advised that her staff were unable to remember the other patients. She assured us, but did not provide any evidence, that the scripts would have been cancelled and that the PBS would have recovered the money in the normal manner. We note that during the discussion about patient RG Ms Sadri advised that in December 2022 she ordered 6 vials of Stelara that were not dispensed in December. This is immediately prior to the period that the PSU investigated and may address the PSU's concern that "from 4 January 2023 to 21 March 2024 … [t]he number of Stelara 45mg vials dispensed was greater than the number of vials received from [the supplier]" (page 13 of the PSU report). This is a detail that needs to be further investigated by investigating authorities but potentially addresses concerns about only one patient and does not change our view. 40. We note that the PSU report states that there are numerous other patients with similar issues. We find it strange that Ms Sadri attended the hearing without any adequate explanation that may have addressed the PSU concerns."
In respect of Points L and M of the PSU's summary the delegates recognised that there was an error and that the procedures identified had subsequently been complied with.
The Decision then concluded at paragraph 41 that for "the reasons discussed above, the panel formed the view that [the Appellant's] practice does pose a risk to the health or safety of the public".
It is then recorded that in summary, these reasons are: "A - A failure to exercise responsibilities as a proprietor. B - A failure to improve following counselling. C - Allegation of PBS fraud."
In respect of reason A, the delegates stated: "42. Ms Sadri has, by her own admission and in the view of the panel, failed to exercise her responsibilities as a proprietor. We note that Ms Sadri does not dispute the concerns raised by the PSU in items A - M (excluding D) and acknowledges that she is responsible for the errors made by her employees. In our view, these errors have in large part occurred because Ms Sadi failed to adequately train her staff and failed to audit her pharmacies to ensure that policies and procedures were implemented and followed through correctly. This lack of training and auditing has directly resulted in a risk to the health or safety of the public by mistakes being made that could have been avoided. 43. We note with concern that Ms Sadri repeatedly referred to "one-off" mistakes. It is a contradiction in terms to claim that there has been a series of one-off mistakes. It is clear that the mistakes were systemic and occurred because of Ms Sadri's failures as a proprietor."
In respect of reason B, the delegates stated: "44. As noted above, a 2019 complaint resulted in a Council counselling session regarding conduct. The Council expects that when a practitioner is counselled they will listen to the concerns expressed by the Council in relation to the complaint and take action to improve their practice. At the very least, action taken by a proprietor should include ensuring that sound policies and procedures are in place, staff training is adequate and ongoing, and there are good audit processes in place to ensure that policies are implemented. Unfortunately, Ms Sadri has clearly not heeded the lessons of the complaint that resulted in counselling. The failures of proprietorial oversight would be concerning in a practitioner before the Council for the first time. For a practitioner such as Ms Sadri, with a history of complaints and a "counselling regarding conduct" on her record, they are an indication of a practitioner unwilling to take seriously her responsibility to minimise any risk to the public. 45. We note that even though Ms Sadri must have been reminded of her proprietorial obligations by the PSU inspection she did not take immediate action. She is obviously aware of her history of complaints and we are surprised that she was not immediately jolted into taking urgent action to address the PSU concerns. Instead, it appears from the dates on the documentation that she has provided that she only acted when she received the notice of the section 150 hearing. 46. The lack of action following the counselling and the lack of immediate action following the PSU inspection give us no confidence that Ms Sadri will follow through on her assurances that she will address the PSU concerns which are not directed only at alleged fraud."
In respect of reason C, the delegates stated as follows: "47. We note that it is our role to assess the risk to the public. It is not our role to investigate the allegations of fraud. We did not find Ms Sadri's explanations convincing and therefore we believe the allegations need to be investigated by the appropriate authorities. In the meantime, we believe there is a clear risk that systematic PBS fraud may have been taking place at the Pharmacy. The risk to the public in this case is not that medications are being misused or abused but rather that the public is being defrauded of large sums of money."
It will be seen that in each of these categories summarised, the delegates applied the test of risk to the health or safety of the public.
The following question was then posed, namely, whether the circumstances are such that it is otherwise in the public interest that action be taken that affects the Appellant's practice which was dealt with as follows: "48. The public has an overriding expectation that pharmacists will always maintain a high level of professional competence, accountability and conduct which includes observing and practicing the principles of ethical conduct and adhering to the applicable legislation and the accepted policies, procedures and guidelines of the profession. This expectation relates to the fact that pharmacists have been entrusted with the possession of high-risk drugs and the associated risk to the public, and also entrusted with participation in the PBS and the large sums of public money involved in that scheme. A pharmacist that does not meet these high expectations places the public at risk of the misuse and abuse of high-risk drugs and/or the misuse of scarce public funding. 49. PBS fraud is a clear breach of the trust that the public places in the pharmacy profession. We believe that the seriousness of the allegations against Ms Sadri mean that it is in the public interest that action be taken that affects the practitioner's practice."
The delegates also then considered whether there are conditions that could be imposed that would sufficiently mitigate any identified risks to the health or safety of the public and concluded as follows: "50. We carefully considered whether there are conditions that would sufficiently mitigate the risks to the public that we have identified. To be clear, we have three major areas of concern: • Ms Sadri has by her own admission failed to exercise her responsibilities as a proprietor. This failure has resulted in avoidable errors by her employees and consequent risk to the public. • Ms Sadri has a history of complaints against her, including a complaint that resulted in counselling regarding conduct. Despite this, she has failed to take action to ensure that her conduct as a proprietor is, to the greatest extent possible, beyond reproach. • There is a serious allegation of PBS fraud which Ms Sadri did not adequately address at the hearing, nor did she give any indication that she has taken any meaningful action to investigate the concerns raised. 51. Putting aside the PBS fraud allegation for a moment, we believe that this is a conduct matter, rather than performance, because of the fact that these proprietorial problems are ongoing following counselling in 2019, and because Ms Sadri was able to demonstrate during the hearing that her knowledge and understanding of her obligations is adequate. Therefore, we formed the view that Ms Sadri has chosen not to act in accordance with her obligations, as opposed to being unaware of her obligations. In these circumstances, there would need to be strict conditions to mitigate the risk to the public. 52. When we considered the PBS fraud allegation in addition to the other concerns, we formed the view that the risks to the public cannot be sufficiently mitigated by conditions. The number of previous complaints, the absence of improvement following counselling in 2019 and the serious allegation of PBS fraud following a similar allegation in 2021 indicate that Ms Sadri is unwilling to improve her practice despite multiple serious concerns being raised over many years. We have little confidence that conditions would be sufficient to protect the public."

Appellant's Points of Law Raised

In the Appellant's written outline of submissions it is stated that the grounds of appeal overlap considerably and focus on two essential aspects, namely the Decision being beyond power and secondly, the Council's denial of procedural fairness to the Appellant.

The Beyond Power Argument

In relation to the beyond power argument the Appellant emphasises (by way of underlining) the nature of the power of the Council pursuant to s 150(1) of the National Law that it is "for the protection of the health or safety of any person or persons".
In the Appellant's written submissions the argument then proceeded as follows: "8. The Respondent (at [41] of the Reasons) relied upon three distinct reasons why they formed the view the Appellant's practice posed a risk to the health and safety of the public. One of the reasons was in respect of unproven allegations of PBS fraud (at [47] of the Reasons). 9. The Respondent, on the one hand, accepts it is not their role to investigate such allegations, but then proceeds to form a belief that "there is a clear risk that systemic PBS fraud may have been taking place at the Pharmacy". The Respondent then accepts that the risk is unconnected to the health and safety of the public, being a risk that "the public is being defrauded of large sums of money". 10. The Respondent impermissibly proceeds to reach the state of satisfaction required under s150(1) of the National Law to enable it to make the Decision, based upon a reason unconnected with the source of the power as it is unrelated to the protection of the health or safety of the public. 11. Failure of the Respondent to comply with a mandatory statutory limit on its jurisdiction, being limited to the "health and safety of the public" will constitute jurisdictional error. 12. There is no doubt the Respondent made the Decision to suspend, rather than the imposition of conditions, as a result of the finding of a risk due to the allegation of PBS fraud (see [52] of the Reasons). The Decision was not stated to be made pursuant to the public interest, but to "mitigate the risks to the public". This encapsulates the error of the Respondent, who has made the Decision based upon any type of alleged risk, rather than the specific risk set out in the legislation. 13. A supposed risk due to an unproven allegation of a risk to the Commonwealth's revenue cannot be considered to be a risk to the health or safety of the public. The Respondent has acted beyond power and did not have the jurisdiction to make the Decision, and therefore the Decision was no decision at all."
The Council in its outline of submissions addresses this core ground of appeal as follows: "16. The appellant contends that the Decision was beyond the power in s 150 of the National Law: AS, [7]-[13]. 17. The appellant relies in this regard solely on Council's concerns regarding the allegation of PBS fraud. She contends that it was impermissible for the Council to conclude that the allegation of PBS fraud gave rise to a risk to the health and safety of the public: AS, [10]. 18. There are a number of flaws with this argument. 19. First, the Council clearly considered that the PBS fraud allegation was a matter that required a suspension in the "public interest": Reasons, [49]. The appellant does not advance any challenge to that conclusion in her submissions, which was evidently correct. The concept of "the public interest" encompasses "wider community interests such as the standards to which human conduct is to be held", including whether practitioners exhibit traits consistent with the honourable practice of an honourable profession: Pharmacy Council of NSW v Ibrahim [2020] NSWSC 708 at [32], [35] per Harrison AsJ. The "public interest" about which the Council had concerns was evidently one that was concerned with the overall protection of the public's health and safety. Indeed, in Medical Council of New South Wales v Schwartz [2022] NSWCATOD 80 at [117], the Tribunal accepted that inappropriate Medicare billing raised an issue of whether a suspension was appropriate in the public interest. 20. Thus, even if the Council did not have a basis to conclude that this allegation gave rise to a risk to the health and safety of the public (which is denied for the reasons set out below), there was an independent basis for the Council's decision (namely, the public interest). 21. As a result, even if there was some error (which is denied) that error could not realistically have resulted in a different outcome, was therefore immaterial and thus does not provide a basis for setting aside the Tribunal's decision. 22. Second, the appellant appears to submit, in reliance on Reasons, [52], that the Council did not decide to suspend the appellant's registration for reasons related to the public interest. This is wrong. In this regard, the Reasons are not to be "construed minutely and finely with an eye keenly attuned to the perceptions of error": Minister for Immigration & Ethnic Affairs v Wu Shan Liang (1996) 185 CLR 259 at 272 per Brennan CJ, Toohey, McHugh, Gummow and Kirby JJ. The Council's reference in Reasons, [52] to the "risks to the public" was evidently intended to encompass its conclusions at [49] regarding the public interest. Indeed, in [50] and [53] the same phrase - risks to the public" - is used by reference to "the reasons outlined above", which on a fair reading includes those matters affecting the public identified at [49]. 23. Third, the appellant contends at AS, [9] that the Council "accepts that the risk is unconnected to the health and safety of the public". The Council did not, and does not, accept this. Indeed, Reasons, [47] is inconsistent with this proposition. 24. Fourth, it was open to the Council to consider that the allegation of PBS fraud gave rise to a risk to the health and safety of the public. The Council acknowledged at Decision, [47] that it had not identified a risk, in this regard, that "medications are being misused or abused", but nevertheless considered that a risk to the health and safety of the public existed by reason of "the public being defrauded of large sums of money". This conclusion was open to the Council. 25. As Meagher JA explained in Health Care Complaints Commission v Do [2014] NSWSC 307 at [35], the objective of protecting the health and safety of the public includes upholding public confidence in the standards of the profession. As Griffiths AJ observed in Callan v Medical Board of Australia [2024] NSWSC 336 at [93], "the concept of "public confidence" is necessarily implicit in the objective of protecting the health and safety of the public". It is clear from [48] of the reasons that the Council was concerned about precisely these matters by reason of the allegations of PBS fraud."
In her Submissions in Reply, the Appellant argued that the following factual matters require resolution: 1. whether the decision was made for "the protection of the health and safety of the public"; 2. whether the decision was made in the "public interest"; or 3. whether the decision was made for the "protection of the health or safety of the public" and also in the "public interest".
The Appellant then argued as follows: "4. In the event, the Tribunal finds the Decision was based upon either 3(a) or 3(b), the point of law, is whether an allegation of PBS fraud falls within the scope of either the "protection of the health and safety of the public" or the "public interest" as those phrases are properly construed under s150 of the National Law. 5. In the event, the Tribunal finds the Decision was based upon 3(c), then two further legal issues arise; whether this is permissible under s150 of the National Law and the applicability of the doctrine of "materiality". 6. The Appellant's position is on a plain reading of the Reasons that the Decision was based upon 3(a). The Respondent's reference at RS at [19], to the Reasons at [49], is far from "clearly considered" suspension, with the decision maker's reference to "taking action that affects the practitioner's practice" rather than any express mention to "suspension"."
The Appellant argued that the Decision was made under the first of the three options set out above and was impermissible for the reasons set out in her original submissions.
The Appellant then argued that if the Tribunal finds the Decision is grounded in the second option, the "public interest", it must approach the matter on the basis that it is a reference to the public interest in the protection of the health and safety of the public, and the Appellant's alleged conduct is not capable of falling within "public interest" as dealt with in the decision by the Court of Appeal in Pridgeon v Medical Council of New South Wales (2022) 108 NSWLR 263.
Lastly, the Appellant argued that if the Tribunal finds the Decision is grounded in the third option, she submits the reasons appear to be created from a generic template which has led the Respondent down a legally erroneous path in failing to properly construe and apply s 150 of the National Law.
In oral submissions Counsel for the Appellant submitted that the simple proposition was that the allegation of PBS fraud referred to in the Decision is unconnected with the health or safety of any person or persons.
The Appellant also contended that s 150 did not permit the Council to rely on both of the limbs in s 150(1)(a). It was argued, that because of the disjunction "or", if it was appropriate to take action under the first limb it was not open to the Council to act under the second limb. As I understood the further argument it was that the Council could not combine the two limbs in its consideration of the issues.
The Appellant raises no express or contextual indication to support her interpretation and no authority pointing to the interpretation advanced.
I reject the Appellant's arguments as to the two limbs of s 150(1). The Council is entitled to give consideration to each of the two limbs. The second limb is an alternative basis requiring the Council to act if the requisite satisfaction is reached. The Council is also not confined to acting on the basis of one limb only. Satisfaction as to each of the two limbs, or both, imposes on the Council the obligation to act.
If there are two independent bases on which the decision rests, then an appellant will fail unless both are set aside (Reimers v Medical Board of Australia [2024] NSWCA 164 at [82]).
No point of law is made out on the Appellant's behalf on this interpretation issue.
As to the Appellant's core argument about the exclusion of allegations of PBS fraud from consideration in a s 150 hearing and determination the Respondent drew attention to the following. In Pridgeon v Medical Council of New South Wales [2022] NSWCA 60; 108 NSWLR 263 the Court of Appeal (Bell CJ, White JA and Harrison J) ("Pridgeon") at [27] quoted with apparent approval the consideration of s 150 in Ghosh v Medical Council of New South Wales (2020) 102 NSWLR 303 relied upon by Dr Pridgeon which I have quoted above. As that summary from Ghosh makes clear the "public interest" consideration will always also include the need for patients and others to have confidence in the competence of practitioners and that practitioners will exhibit traits consistent with the honourable practice of an honourable profession.
In Callan v Medical Board of Australia [2024] NSWSC 336 Griffith AJ held at [93] that the concept of "public confidence" is necessarily implicit in the objective of protecting the health and safety of the public (as considered in Health Care Complaints Commission v Do [2014] NSWCA 307 at [35] per Meagher JA).
The Tribunal in Medical Council of New South Wales v Schwartz [2022] NSWCATOD 80 at [117] accepted the argument that incorrect billing does not directly affect patient health or safety but does raise an issue of public interest and Medicare fraud may justify immediate suspension of a practitioner's registration in the public interest.
The Respondent then submitted that the last sentence of each of paragraphs [47] and [48] of the Decision was consistent with the approach of the Court in Pridgeon and further that the reasoning at [30] of the Decision, which is set out above, further supports the relevance of the alleged PBS fraud to the public interest.
I do not accept the Appellant's arguments that the Decision impermissibly included a consideration of the alleged PBS fraud for the following reasons.
First, the Decision must be read as a whole and the consideration of the alleged PBS fraud in its proper context. The Appellant fails to come to grips with the precise nature of the allegation. Dispensing of medicines and claims for dispensing is, as accepted by the Appellant, a core part of the practice of pharmacy. Pharmacists have an important role to play in the integrity of the system.
The conduct giving rise to allegations of fraud is detailed in the PSU Report before the Council. At pages 7 to 15 of the Report there is a detailed analysis of conduct which potentially constitutes "PBS fraud". That phrase is a shorthand way of describing the Appellant's conduct.
The conduct is within the summary of findings in D. It is not there described as "PBS fraud", but the detailed analysis of the conduct referred to gives rise to the allegation.
However, the conduct concerned the treatment by the Pharmacy of prescriptions for a range of patients, the question of whether the drugs prescribed were in fact supplied, and reimbursed by PBS for drugs which may not have been physically supplied to the patient.
The PSU Report also records allegations of a "kick-back" to customers of 25% while the Pharmacy may have potentially received 75% of financial gain by processing prescriptions without the provision of the medication to the patients.
The basis for the description of alleged "PBS fraud" was identified and recorded in the Decision at [25] to [40] set out above. These paragraphs clearly analyse the issues of concern to the delegates. They are not matters unrelated to, or beyond, proper consideration in s 150 proceedings.
Secondly, it is clear that the allegations concerning this conduct, according to the PBS Report, potentially contravened clauses 55, 176 and 177 of the PTGR. It is not possible to isolate the alleged conduct from the practice of pharmacy. Those clauses are directly relevant to the practice of pharmacy and the duties of pharmacists. The alleged conduct cannot be equated to a motor vehicle infringement or tax fraud.
Thirdly, the Decision of the Council separately identified risk to the health or safety of the public by the numerous mistakes in dispensing identified by the PSU Report and the delegates (paragraph [42] of the Decision). The first limb of s 150(1) could therefore be engaged.
Separately, and in addition, the second limb was engaged at paragraph [48] of the Decision. Counsel for the Appellant was unable to point to error in that reasoning if the wider view of public interest identified in Pridgeon referred to above was followed.
The Court in Pridgeon did not eliminate a consideration of the public interest in the second limb of s 150. The Court held at [68] that the content to be given to that protection must take its meaning from the conduct of the practice in respect of which a practitioner's professional registration is granted. The broader consideration of the administration of justice or undermining the rule of law which was at issue in that case was beyond the reach of the public interest with which s 150 is concerned.
In contrast, in the matter before the Council, the conduct alleged was directly related to the practice of pharmacy and integral to the standard required of a registered practitioner.
Fourthly, the delegates of the Council were correct in their view that it was not their role to investigate the allegations of fraud. That, however, did not preclude them from having regard for the allegations The s 150 proceedings do not require the Council to embark on a detailed enquiry to make concluded findings of fact.
In my view, for the reasons set out above, the references in the Decision to PBS fraud when considered in their proper context cannot lead to a conclusion that the conduct relating to that issue was outside of the scope of s 150 of the National Law as claimed by the Appellant.
The Council was entitled to proceed on each limb of s 150. The Appellant has failed to establish any error and, importantly, no error by the Council in respect of any point of law.

Denial of Procedural Fairness

In support of this argument the Appellant contended that the Council formed a view, without investigation, which was adverse to the Appellant in respect of the allegations of PBS fraud. It is argued that the Council has disregarded the presumption of innocence and reached a belief and a view, which on a fair reading of the reasons, is essentially, a finding that the allegations contained within the report are likely to be true. The Council delegates questioned the Appellant with respect to these matters but accepted that it was not within their role to investigate and then proceeded to make adverse findings of risk and unconvincing explanations.
It was further argued that there was an apprehension of bias on behalf of a Council delegate who interrupted the Appellant at the s 150 hearing and also made comments throughout the transcript pointing to a fair-minded observer coming to the view that the Council had pre-judged the matter and lacked the necessary impartiality to conduct a fair hearing.
It was argued that the finding that the Appellant had not improved following the counselling session in 2019 was never put to the Appellant and that it was obviously adverse and never raised in the hearing thereby denying the Appellant procedural fairness.
The Council counters the submissions in relation to a denial of procedural fairness or apprehended bias by submitting, first, that the argument that the Council formed a view without investigation and disregarded the presumption of innocence is contradicted by a fair reading of the Council's reasons. The delegates stated expressly (at [47] of the Decision) that it was not their role to investigate the allegations of fraud and that they needed to be investigated by the relevant authorities.
The Council argued before the Tribunal that that approach was consistent with the Council's functions under s 150 of the National Law and being required to conduct a risk assessment it was plainly necessary for it to consider the allegations made and whether they had substance.
In respect of the allegation of apprehended bias against one of the panel members, the Appellant belatedly pointed to two passages in the transcript of the s 150 hearing but made no serious attempt at the hearing to demonstrate how the comments satisfied the relevant tests for apprehended bias. The Appellant did not address the principles as set out in Ebner v Official Trustee in Bankruptcy [2000] HCA 63; 205 CLR 337 at [6] - [8].
One comment addressed to the Appellant in the s 150 hearing was to the effect that she had pharmacists in charge "and none of them follow the law". The other, is said to be a "sarcastic comment" referring to the procedures to be followed in the Pharmacy, as "fantastic procedures".
The first comment must be considered in context. As pointed out above, there were multiple contraventions of law, the PTGR, alleged involving pharmacists and which were not challenged by the Appellant. The second comment was in the context of the Appellant pointing to procedures in place which, it appears, were not effective.
The Appellant also argued that she was denied procedural fairness by reason of a "finding" by the Council that she had not improved following counselling by the Council following a complaint about her conduct in 2019, a matter put to the Appellant in the hearing. It is argued it was relied upon without any details of what counselling was undertaken or to address the issue.
The Appellant was given written notice of the proposed s 150 proceedings. Included in the notice were details of previous complaints made against the Appellant. One of those complaints was the 2019 complaint referred to above. The complaint fell in the category described as "Unlawful Dispensing". The summary of that complaint was set out as follows: "Complaint received relating to dispensing practices. The anonymous complainant alleges illegal dispensing practices by staff at Priceline Pharmacy St Marys. The concerns raised relate to dispensing of S8 medications (Oxycontin) in exchange for prescriptions for different medication (Diabetes and Heart medication) and dispensing of PBS Subsidised medications for free." Counselling occurred in respect of that complaint and conduct.
The Appellant was thus put on notice of the previous complaints for the purpose of the s 150 proceedings.
The Council addressed this issue at paragraphs [10], [11], [24], [44], [50], [51] and [52] of the Decision.
In the appeal the Council argued that the relevant principles in respect of those additional grounds raised by the Appellant are as follows (references omitted): 1. A decision-maker is not required to be free of a preliminary reaction or an inclination for or against an argument or conclusion. A decision-maker is required to have an "open mind" not an "empty mind". 2. Apprehended bias is demonstrated only where it can be shown that a bystander would reasonably apprehend that the decision-maker was so committed to a particular conclusion as to be incapable of alteration, whatever evidence or arguments the appellant might present. 3. A decision-maker is entitled to engage in a robust and forthright testing of an applicant's claims and evidence. The delegates may have particular matters troubling them for resolution, which require questioning and doubt which are entirely appropriate. 4. Indeed, if the delegates do not test the position of the appellant on the material before it, there is no one else to do so. If it does not make a person aware of its concerns, its concerns may go unaddressed and unanswered. 5. A decision-maker may properly apply reasonable efforts to confine proceedings within appropriate limits to ensure time is not wasted.
I accept that for present purposes that summary will suffice.
The Council argued that there is nothing in the transcript of the hearing before the delegates that would suggest that the delegates went beyond what they were entitled - and indeed obliged - to do in seeking to determine what action (if any) was appropriate in light of the matters raised in relation to the Appellant's practice. I accept that argument.
In relation to the argument that the finding that the Appellant did not improve following the counselling session in 2019 was not, but should have been, put to the Appellant the Council argued that the submission proceeds from a misapprehension as to the rules of procedural fairness. The Council argued that in relation to protective proceedings such as those under s 150, there is no obligation on the decision-maker to provide specific particulars of the allegations being made: Lindsay v New South Wales Medical Board [2008] NSWSC 40 at [96]-[99] per Hall J and Attai v Psychology Council of New South Wales [2022] NSWCATOD 136 at [55].
The Council also pointed to the fact that there is no obligation for the decision-maker to expose mental processes or provisional views.
The Council then submitted that in the present case: "(a) The appellant is taken to be aware that the Council must consider past complaints as required by s 41O of the National Law. (b) The appellant was obviously aware that a complaint had been made against her and she had been counselled as a result of that complaint in 2019. (c) The appellant was aware that the Council had concerns in relation to the matters occurring at the Blacktown Pharmacy as set out in A-M of the PRU's Summary of Findings. (d) The appellant accepted in her response to the Council delegates that their concerns (other than in relation to item D) were valid concerns. (e) The rules of procedural fairness did not require the delegates to disclose the conclusions that they were considering reaching in relation to those matters."
I reject the argument that the Appellant was denied procedural fairness in relation to this previous complaint. I do so for the following reasons: 1. the Appellant was on notice of the complaint; 2. the matters set out at [84] above; 3. the nature of the counselling was in respect of similar allegations of dispensing practices which are detailed in the summary provided in the PSU Report. The 2019 concerns are not dissimilar to the complaints before the Council. The Council was in the circumstances not obliged to set out to the Appellant the observation that there is an expectation that when a practitioner is counselled they will take action to improve their practice. The very purpose of counselling is to achieve that outcome. In addition, counselling need not have occurred in respect of precisely the same conduct.
The argument that the Council made findings contrary to the presumption of innocence is contrary to the reasoning and text of the Decision and is without substance.
The Appellant has failed to make out a case for apprehended bias. The Appellant has failed to make out a case for a denial of procedural fairness. In neither case can it be said that the relevant principles set out above are met.
The passages in the transcript when taken in context do not point to prejudgment. A fair-minded observer is taken to be acquainted with the facts and the legal process being undertaken.
The Appellant has not made out its case of a denial of procedural fairness. There was, in my view, no "practical injustice" (Re Minister for Immigration and Multicultural Affairs; Ex Parte Lam (2003) 214 CLR 1 at [37]-[38]).
The Decision is affirmed. The Appeal should be dismissed.

Costs

The parties will be given the opportunity to address the question of costs.

Orders 1. Appeal dismissed. 2. Any party seeking an order for costs file and serve submissions in support of such application not exceeding 10 pages in length within 14 days. 3. Any party resisting an application for costs file and serve submissions in opposition to such application not exceeding 10 pages in length within 28 days. 4. Any party filing submissions pursuant to orders 2 or 3 include in such submission whether costs can be determined on the papers without an oral hearing pursuant to s 50(2) of the Civil and Administrative Tribunal Act 2013.

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: 26 September 2024

Medical Practice Act 1992(NSW)

(2020) 102 NSWLR 303

(2022) 108 NSWLR 263

At a glance

Court

Decision date

Catchwords

Source

Catchwords

Judgment (10 paragraphs)

Parties

Legislation Cited (1)

Cases Cited (20)

Cited By (1)