Hanna v Pharmacy Council of New South Wales

The complaints before the Council at the s 150 hearing

1. On 13 December 2019 the Australian Health Practitioner Regulation Agency (Ahpra) received a complaint from a brother of a patient who received "7 full packets of Codeine" which were all dispensed on the same day (180 tablets). The complainant asserted the brother had a known drug addiction. The codeine tablets were dispensed by a pharmacist employed at the Arncliffe Pharmacy.
2. On 18 January 2021 Mr Hanna received written notification from the Council of a complaint from Ms Alana Meaklim. Ms Meaklin is a pharmacist at Austin Health, Victoria. She notified Ahpra of an adverse reaction suffered by a patient admitted to hospital after obtaining a prescription for sildenafil 50 mg after an online consultation with a medical practitioner at Tweed Heads through a web-site "Pilot". The complaint notes that sildenafil was dispensed by a Pilot affiliated pharmacy, Shire Compounding Pharmacy. At the time the patient received the sildenafil tablets he also received 4 x tadalafil 20mg tablets with instructions to take 1 tablet of either medication before sexual activity and not to combine the medications together. Ms Meaklin asserted the patient did not have any contact with the prescribing doctor (no phone or telehealth consultation). Sildenafil is not a compounded medication but rather a drug registered on the Australian Register of Therapeutic Goods and marketed under the trade names Viagra or Revatio. The patient is reported to have suffered a drop in blood pressure requiring hospitalisation after he took sildenafil.
3. On 9 June 2021 Mr Hanna was notified by the Health Care Complaints Commission (HCCC) of a complaint received from a person (Mr RM) who reported he had previously purchased sea sickness tablets from Bova Compounding but had been referred by that pharmacy to Nile Compounding. The complainant reported that the seasickness tablets provided had made his partner "very sick and drowsy". The name of the patient has not been supplied to Mr Hanna. As a result, Mr Hanna asserts he is unable to verify any prescriptions or orders.

The Council's reasons

1. The Council's reasons, which are dated 1 November 2021, were provided to Mr Hanna after business hours on that day. The Council provided extensive reasons for its decision conveyed to Mr Hanna on 13 October 2021.
2. The Council's reasons commence by relating factual matters about the practitioner's registration and his ownership of the pharmacies.
3. At [2] to [4] the reasons set out details of the three complaints (two received from Ahpra and one from the HCCC.
4. Between [11] and [18] the reasons record Mr Hanna's evidence about the acquisition of the five pharmacies, the operation of the pharmacies, the employees and prescriptions dispensed.
5. The reasons next, in accordance with s 41O of the National Law, refer to a complaint in May 2018 which related to the advertisement of Sea Sickness capsules advertising on the website of Nile Pharmacy. At [25] the reasons note: "After the interview Mr Hanna was asked to provide updated information which was received and assessed as satisfactory. The complaint was closed on 14 January 2019".
6. Notwithstanding the delegates' recording that the May 2018 complaint was dismissed, they found the previous complaint "was relevant to current matters". The reasons explain at [26]: "…We note that the previous complaint referred to similar issues to the current matter with respect to lack of proprietorial oversight and training of the staff; selling products using an online platform to advertise the product; efficacy and contents of a compounded product; preparation of a compounded medicine contrary to the Board's guidelines for compounding of medicines".
7. The delegates explain that the complaint dated 3 June 2021 involved the same sea-sickness medication from the same pharmacy and go on to record at [27]: "The complainant further alleged that the medication, 'ET seasickness capsules' were shipped to them without speaking to a pharmacist or without receiving proper advice. The website was the same online platform that was referred to in the previous complaint that advertised the same compounded medication in breach of the TGA guidelines".
8. The reasons then explain that the complaint dated 10 January 2021 involved the same drug, namely sildenafil, as "the previous complaint in May 2018". However, the delegates explain at [28] that the drug which was the subject of the complaint in 2018 was a compounded product and the tablets in the present complaint were of "commercially available sildenafil using a similar online platform whereby communication between the patient and the Shire Pharmacy was via an electronic means". The delegates explain: "This complaint and the previous complaint raised similar concerns for the health and safety of the public whereby the communication between the patient and the Shire Pharmacy was not-face-to-face."
9. At [29] the delegates refer to the complaint dated 2 September 2020 and explain this was medication [codeine] dispensed "without sufficient oversight" by the pharmacist, concluding the complaint was similar to the previous complaint "in that a similar lack of proprietorial oversight and an apparent lack of training of the staff was apparent".
10. The delegates then pose the question "Does the practitioner have the necessary standard of practice, knowledge and understanding so as not to pose a risk to the health or safety of the public?"
11. After reciting briefly Mr Hanna's experience and background over 10 years, the delegates note he was an intern pharmacist under the guidance of Mr Anton (the former owner of the Nile and Arncliffe pharmacies)
12. At [32] the delegates state: "We were very concerned that Mr Hanna's work experience is limited to his involvement within the pharmacies that he currently owns. Mr Hanna stated that he 'learned a lot' in the couple of years before he became a proprietor, but the time 'went quickly' and he 'gained experience from younger and older pharmacists, some of whom worked with his father'. We acknowledge that Mr Hanna worked with ex-proprietors who were employed at the Nile Pharmacy and Mr Hanna asked them questions relating to running a business. He used them as mentors whilst gaining experience in the day-to-day aspects of running a pharmacy."
13. The delegates then record questions they posed to Mr Hanna about his experience, including as a school-boy when he worked in three pharmacies owned by his father. Mr Hanna's responses that he had done accounting courses, had kept abreast of responsibilities by observing, speaking to peers and doing training and CPD are recorded.
14. At [34] the delegates acknowledged Mr Hanna had read the Board Guideline for Proprietor Pharmacists recently and also a year ago, but said "we were extremely concerned that he was not aware of the guidelines at the time of the purchase of the pharmacies". The delegates also explained: "We were concerned that Mr Hanna's lack of knowledge and understanding of the Board Guidelines poses a risk to the health and safety of the public."
15. Thereafter the delegates referred to the 2018 complaint explaining that "Mr Hanna dismissed his lack of proprietor oversight …as 'an oversight by me;'" and recorded that Mr Hanna "did not appear to take responsibility for the situation but blamed his staff for the advertisement".
16. The delegates then referred to their questioning about how Mr Hanna conducted supervision of the Sefton Pharmacy and expressed criticism that Mr Hanna did not have documented records for his supervision meetings. (I note that this pharmacy was sold in 2016).
17. At [39] the delegates recorded that Mr Hanna does not currently work as a rostered pharmacist in any of his pharmacies but noted that he visits each of his pharmacies on a weekly basis. The delegates noted Mr Hanna's evidence that he works three to four hours each week at Nile Pharmacy mainly to oversee compounding and that he works four to five hours at Filled Pharmacy every day. Mr Hanna is recorded as advising Filled Pharmacy produced about 250 products per day and around 500 prescriptions per day. The delegates concluded: "We were very concerned that Mr Hanna did not have any documented records for his attendance at each or any of his pharmacies and were extremely concerned that it would be very difficult for Mr Hanna or anyone to adequately manage that workload and number of management meetings per week on a long-term basis"
18. The reasons next address matters relating to compounding. At [40] the delegates note that Mr Hanna was trained by Medisca in non-sterile compounding in 2014 and that prior to that time his compounding knowledge was derived from personal research and discussion with other trained compounders. The delegates record "He has never worked at other pharmacies to gain compounding experience". They also recorded Mr Hanna's evidence that he does not currently compound "but ensured staff complied with the procedures that he has implemented in his pharmacies". The reasons go on to explain that Mr Hanna has attended other compounding courses run by Medisca and PCCA but note he did not give specific details of when he attended "but generalised that the courses involved regulatory compliance training, beyond use dates, the changes in the APF guidelines on compounding and the 2015 Board guidelines".
19. At [41] the delegates record that Mr Hanna was "not exposed to compounding prior to ownership" and go on to note that he began to compound at Nile Pharmacy in 2014 where he developed his own Standard Operating Procedures (SOP) and he personally trained his staff. The reasons then refer to two pharmacists employed by Mr Hanna. The reasons note that one pharmacist employed by Mr Hanna since 2017 is now pharmacist in charge at Filled Pharmacy and Mr Hanna trained the pharmacist who currently compounds at Nile Pharmacy. They noted this pharmacist had not undergone any training from Medisca or PCCA but Mr Hanna was comfortable that he had the skills to compound and that he was booked in for the next Medisca training. The reasons note four technicians are employed to assist the pharmacist to compound approximately 20 products per day. The delegates concluded: "We were very concerned that Mr Hanna did not have any detailed documentary proof of the training that was provided and did not regularly formally audit the skills of Mr Saad. This poses a risk to the health and safety of the public".
20. At [42] the delegates expressed concern about a website for the Shire Pharmacy which refers to this being a compounding pharmacy, noting Mr Hanna's evidence that this pharmacy does not and has never compounded. The delegates concluded the website was misleading, noting it contained medication reviews although there is no remuneration available to non-PSB pharmacies to conduct medication reviews. The delegates were also critical of the information that a member of the public could call the Caringbah pharmacy for more information. The delegates concluded: "The misleading advertising poses a risk to the health and safety of the public"
21. At [43] the delegates record the level and type of training given to the 16 compounding technicians employed at Filled Pharmacy of whom approximately 70 per cent were new employees with no compounding experience.
22. At [44] the delegates record their questioning of Mr Hanna about the eight pharmacists employed by him. They record that two of the eight pharmacists are externally accredited. The delegates explain that one pharmacist, who was engaged in training staff, was a compounding trainer at PCCA prior to working at Filled Pharmacy. They also recorded Mr Hanna's evidence that he had personally trained the other pharmacists who did not have experience at a weekend seminar held in May 2021.
23. After recording Mr Hanna's evidence that he kept a staff training log, the delegates expressed concern and refer to Mr Hanna's evidence about his initial review of staff competency and that he gave practical training but did not log or document inaction with staff.
24. The delegates, at [46], address the fact that Mr Hanna has created his own SOPs which he said he updated and reviewed annually and that he followed all recommended SOP processes "including convenient storage of SOP manual near the compounding lab; annual review; records of amendments; version control; communication of changes to staff and staff sign off". However the delegates explained that they were "very concerned that Mr Hanna did not have any form of documentation for audits of regular 'spot checks' or records of 'how he deemed the staff competent; annual staff competency records'". The delegates noted that Mr Hanna agreed that more formal documentation and records of staff competency was a good idea and that he would implement better recording keeping.
25. After questioning by the delegates about external accreditation, they noted Mr Hanna's advice that he was trying to arrange a Gap analysis in November.
26. At [49]-[59] the delegates set out the regulatory framework with particular reference to compounded products as well as the guidelines on compounding medicines.
27. The delegates then refer to the compounded motion sickness treatment (the sea-sickness product) including reference to the dossier provided by Mr Hanna. It is noted this formula is intended for use by sufferers of travel sickness who have been unsuccessfully treated with over-the-counter medications or where commercially available products are unsuitable.
28. The delegates explain that during the period the s 150 proceedings were adjourned, Mr Hanna requested Medisca to provide evidence of the efficacy of the formula. The delegates noted that Mr Hanna had been compounding the formula for several years and questioned why he had not requested Medisca to provide evidence of efficacy earlier.
29. At [63] the delegates explained: "We were extremely concerned that Mr Hanna did not provide any evidence that validated the Formula that was being compounded. We note that Mr Hanna's written submissions included studies on intranasal delivery of low-dose scopolamine but not for oral capsules. The TGA has not approved the Formula. The Cochrane Library did not contain any reviews of evidence for the Formula. There was no evidence of random controlled trials for the Formula. We note that a compounded Formula without any evidence for efficacy poses a risk to the health and safety of the public."
30. The delegates record Mr Hanna's evidence about production and testing of batches of the formula and refer to a report obtained by Mr Hanna in October 2018 of testing conducted by ALS which concluded "not validated" when 2 of 10 capsules tested fell outside the 10 per cent variation. The delegates expressed concern that Mr Hanna did not provide emails and proof of the validated testing recording Mr Hanna's position that he was requested only to provide proof of testing and not proof of validated test results. The delegates then refer to APF 25 which states that batch preparation for compounded products is discouraged and expressed concern that the formula "contained very small quantities (microdoses) of scopolamine (0.2mg) and chlorpheniramine (2mg) which are difficult to weigh and posed a high risk of non-homogeneity. This poses a risk to the health and safety of the public".
31. The delegates record that the patient involved in the complaint on 3 June 2021 felt sick and drowsy after taking the formula and was not given advice on side effects. The delegates said they were concerned the medication the patient took was never batch tested and possible harm was done to the patient. The delegates also expressed concern that Mr Hanna questioned if the medication was purchased from Nile Pharmacy, and "disputed the fact a pharmacist did not speak to the patient/purchaser". Mr Hanna's assertion that Nile Pharmacy counselled every time the product went out in accordance with the Pharmaceutical Society of Australia guidelines, that being in a "'2-way manner' and a 'discussion either verbal or written'" is recorded.
32. At [67] the delegates explain: "Mr Hanna described the counselling as '2-way manner' and a 'discussion either verbal or written'. The patient could order a medication for seasickness online but Mr Hanna argued that the order was not for the Formula but a decision for an appropriate product was determined by the patient and the pharmacist. Mr Hanna disputed the fact that the Formula was available online and that the Formula was being advertised. We were seriously concerned that a simple Google search for the Formula resulted in several advertisements such as ET Sea Sickness www.escapetravelsickness.com.au ; a phone number 1300 SEASICK to order a tailored motion sickness formula; and www.nilecompounding.com.au to "order Sea and Motion Sickness Treatment". We note that Mr Andrew Ettingshausen (also known as ET) has regularly endorsed the Formula (which has been named the same) on Facebook, Instagram and his TV show naming Nile Pharmacy as the makers of the Formula."
33. The delegates next address the issue of Mr Hanna's pharmacies operating "online platforms" and "websites". The delegates noted that all of Mr Hanna's pharmacies received prescriptions from various websites including Doctors2 U and, relevant to the complaint, from Pilot (www.pilot.com.au). At [70] the delegates record Mr Hanna's evidence about his relationship with the Medical Director of Pilot and that he reported Filled Pharmacy/Shire Pharmacy and Nile Pharmacy were preferred partner pharmacies for Pilot. The delegates explained that they were "very concerned" that the arrangement between the pharmacies and Pilot may not comply with the Board's guidelines for dispensing medicine.
34. At [71] the delegates referred to Mr Hanna's evidence about the risk assessment undertaken when supplying prescriptions received from an online platform. They recorded Mr Hanna's evidence that: "'the doctors were very experienced sexual health physicians' who 'followed the Medical Board guidelines on technology-based consultations'. Mr Hanna also stated that he 'followed the guidelines for non-face-to-face consultations'. When asked to provide more details, Mr Hanna stated that he 'was not privy to the doctor's consultation and I don't know the details… however the patient goes through an in-depth patient history with the doctor'. 'I am comfortable that the patient had a thorough consultation with the doctor'. When asked, Mr Hanna stated that he had not 'read all of the medical guidelines on telehealth but had looked at them'. Mr Hanna did not identify the name of the guidelines but generalised that they were to do with telehealth."
35. The delegates go on to refer to the Pilot website which contains two boxes for the patient to tick, namely that the patient "has read and understood the safety information provided to me by the pharmacist and doctor" and "I confirm I have no further questions at this stage".
36. The delegates expressed their extreme concern that using this indirect supply model "it would be very possible for a patient/consumer to bypass any direct involvement with the doctor or pharmacist." They concluded this poses a significant risk to the health and safety of the public.
37. The delegates then recorded their concerns about the "counselling" available to patients needing treatment for erectile dysfunction noting that pharmacists were not required to answer any questions if the patient did not request any further information.
38. At [75] the reasons recite Mr Hanna's evidence about patients who sought advice from a pharmacist namely that in the first three weeks of September 2021, 4,896 patients requested an email 2-way chat and that there were approximately 9,000 patients who did not require a conversation. Mr Hanna was noted to clarify this evidence to the effect the total number of patients was 9,000 and that there would be about 2,098 phone calls made. The delegates explained: "We were very concerned that if Mr Hanna's estimates were correct then approximately 2005 patients (nearly 100 patients per day) would not have had any interaction with the pharmacist and that would also leave the pharmacist to make approximately 100 calls per day to answer the patient's enquiries. This poses a risk to the health and safety of the public."
39. At [77] the delegates express their concern that Mr Hanna's SOP for indirect dispensing did not comply with the PDL guidelines for good dispensing and explained that "written information is valuable but can never replace a face-to-face interaction or verbal communication". The delegates went on to hypothesise that the "indirect dispensing model that Mr Hanna used could allow consumers to falsify their request and receive medication without any direct interaction with the doctor or Mr Hanna's pharmacies". The delegates expressed extreme concern because Mr Hanna stated he had no intention to change his model and concluded this poses a significant risk to the health and safety of the public.
40. In dealing with the complaint made by Ms Meaklim, the delegates noted that Mr Hanna conceded he abrogated his responsibility as a pharmacist but stated the patient was given an opportunity to ask questions. Mr Hanna referred to the patient suffering a rare but known side-effect to sildenafil (Viagra). The delegates expressed extreme concern that Mr Hanna allowed the dispensing of two erectile dysfunction drugs at the one time to a patient which caused harm and led to the patient being hospitalised. (I pause here to note that the complaint made it clear that the patient only took one medication (Viagra) and suffered an adverse side effect.) The delegates explained: "We opined that had the patient personally gone to a doctor and visited a pharmacy face-to-face and spoke to and received counselling from a pharmacist, then the patient may not have suffered serious side effects and would not have had to be resuscitated in hospital."
41. The delegates also expressed their criticism of Mr Hanna's failure to engage in a collaborative approach with the hospital pharmacist or to have communicated with the prescribing doctor to "inform them of the health of the patient". The delegates said this "posed a risk to the health and safety of the public."
42. The delegates return to the issue of Mr Hanna's competencies under the heading "Proprietor Oversight and Training" and they summarise earlier evidence about Mr Hanna's training and experience. At [82] they note Mr Hanna has not worked as a rostered pharmacist for several years and also expressed concern that he has not compounded for a significant or considerable number of years but was responsible for the oversight and training of pharmacists and compound technicians.
43. At [83]-[84] the delegates state: "We acknowledge that the pharmacists did not physically compound at any of Mr Hanna's pharmacies but we were very concerned that inexperienced, newly trained pharmacists responsible for overseeing the work of inexperienced, newly trained compounding technicians posed a significant risk to the health and safety of the public. We were extremely concerned that Mr Hanna did not have ongoing audits for staff competency and did not document his day-to-day reviews of their ability"
44. At [85] the delegates returned to the codeine dispensing complaint which concerned dispensing by an employed pharmacist at the Arncliffe Pharmacy. The delegates note that Mr Hanna, in response to this complaint, wrote to the HCCC and opined that the dispensing pharmacist "exercised sound clinical judgement" and stated the pharmacist had followed the Board's guideline for dispensing and the PSA Professional Practice Standard. (I pause to note that the dispensing pharmacist contacted the prescribing doctor before dispensing the 180 codeine tablets.)
45. The delegates noted the patient's medication prescribed one day before the codeine dispensing was a benzodiazepine and they were critical of Mr Hanna's response to the HCCC and to them.
46. The delegates then record Mr Hanna's continuing professional development for 2020 and 2021 and expressed concern that Mr Hanna had listed courses that post-dated the CPD year, in September 2021. The delegates noted the dates on which Mr Hanna asserted he had conducted weekend training noting the dates were mid-week dates and expressed concern about his evidence on this topic being full and frank.
47. Under the heading "Does the Practitioner's practice pose a risk to the health and safety of the public? the delegates conclude, at [89]-[91], as follows: "Mr Hanna is the subject of 3 open complaints and 1 closed complaint. The complaints involve 3 different pharmacies. The 3 open complaints and the closed complaint combined identify similar issues. Mr Hanna's oversight as a proprietor was lacking. Mr Hanna's pharmacies were responsible for supplying medication that caused 2 patients' harm. We were very concerned that the complaints involve an apparent lack of duty of care to the patient and do not comply with the Code of Ethics. Mr Hanna has demonstrated that his understanding of the Board guidelines, the Code of Ethics and relevant legislation posed a risk to the health and safety of the public. We were extremely concerned that Mr Hanna has allowed the compounding of a product that has not been tested and Mr Hanna did not have adequate evidence that the Formula has been shown to be efficacious and was allowed to be compounded according to the guidelines. We were very concerned that the Formula has been batch manufactured in a quantity of 300 that contained micro doses of active ingredients. We were very concerned that Mr Hanna has only tested one batch in 4 years of compounding the Formula. We note that Mr Hanna compounds 250 products per day. We were very concerned that Mr Hanna has not engaged the services of an independent company to perform a Gap Analysis of his compounding business. We were very concerned that the staff responsible for compounding at Mr Hanna's pharmacies were inexperienced and have not been regularly audited for competence which posed a significant risk to the health and safety of the public. We were extremely concerned that Mr Hanna dispensed 500 prescriptions received from online platforms with no face-to-face contact with the patients. Mr Hanna's SOP for indirect dispensing did not comply with the PDL Good Guide to Dispensing or the PSA Code of Ethics. We were very concerned that Mr Hanna did not counsel patients adequately using online and indirect supply. Mr Hanna placed the onus on the patient to ask questions rather than allowing the pharmacist to interact and ask questions. We were very concerned that Mr Hanna believed the supply of written information using a computer was a suitable alternative to a verbal or face-to-face interaction between the patient and the pharmacist. We were very concerned that Mr Hanna did not perform a suitable risk assessment before supply medications to patients that used an online platform to consult with the doctor and receive supply from Mr Hanna's pharmacies. We were very concerned that a closed-loop supply between the doctor and Mr Hanna using an online platform may exist which did not give the patient any choice. This poses a significant risk to the health and safety of the public".
48. The delegates then considered "What is the public interest and is the Practitioner's practice in accord with the public interest?"
49. The delegates note that the public has entrusted the custody and supply of potent medications to the profession of pharmacy and has "an overriding expectation that pharmacists will behave at all times with the highest standards of trustworthiness, legal compliance and ethical practice."
50. The delegates go on to refer to the public interest being underpinned by an acknowledgement by pharmacists that they possess adequate current knowledge and exercise due care to the patients by maintaining and employing "exemplary knowledge, understanding, judgement, care and practice". The reasons explain that public interest is underpinned by the exercise of adequate proprietorial oversight by pharmacy owners.
51. At [95] the delegates conclude: "We formed the belief that Mr Hanna's actions in abrogating her [sic] responsibilities to exercise adequate proprietorial oversight were not in accord with the public interest. We formed the belief that Mr Hanna has compounded products that did not comply with the regulatory framework for Therapeutic Goods/Medicines in Australia which was not in accord with the public interest. We formed the view that Mr Hanna did not adequately counsel patients when supplying medication using an indirect dispensing model and did not comply with relevant legislation and guidelines which was not in accord with the public interest."
52. The delegates then turn to the question of the imposition of conditions that would be sufficient to mitigate any risks to the health and safety of the public or mitigate concerns regarding public interest. The delegates conclude at [97]: "Given our concerns with Mr Tamer Hanna's actions relate to his oversight as a proprietor, his understanding of the legislation and guidelines concerning compounding and indirect dispensing using online platforms including patient counselling we believe that conditions listed below would be sufficient to mitigate the risk to the health and safety of the public at this time."

Grounds of Appeal on a question of law

1. Mr Hanna relies on Amended Grounds of Appeal in respect of his appeal under s 159B.
2. He asserts a lack of procedural fairness as to the matters the Council was investigating. He further asserts the Council failed to put to him all of the matters on which it intended to rely in making findings adverse against him at the s 150 hearing, and therefore failed to give him the opportunity to respond to those matters.
3. Other procedural fairness grounds relied on are "(c) making adverse findings against the Applicant for disputing whether or not the seasickness complaint was even genuine when the Respondent failed to provide full information to the Applicant to allow him to properly respond to this compliant; (d) Failing to provide the Applicant with the opportunity to properly address matters raised by the Respondent, which were adverse; (e) Conducting the hearing in such a manner as to deprive the Applicant of a fair hearing; and (f) Putting to the Applicant matters without any factual basis; and (g) Making findings against the Applicant that he may have breached board guidelines regarding exclusive supply from a third party despite acknowledging at the hearing the Respondent had been provided with a copy of the services agreement and had in fact approved the agreement when it approved the application of Filled Pharmacy"

Procedural fairness grounds

1. The principles in respect of procedural fairness in administrative decision making under the National Law are well established (see Kioa v West (1985) 159 CLR 550; [1985] HCA 81).
2. Mr Hanna was advised by letter dated 3 September 2021 about the s 150 hearing. The letter informed Mr Hanna that: "On 26 August 2021 it considered two complaints received on 10 January 2021 and 3 June 2021 along with other complaints about your conduct. The Council will now consider whether it is appropriate to suspend or place conditions on your registration while these complaints are assessed".
3. The notification of the s 150 hearing from the Council also referred to the copies of documents "the Council will consider in its decision". A folder of documents was provided by the Council. The documents included are listed as Attachment 1 to the Council's reasons and include those relating to the 2018 complaint which was closed, a copy of the codeine complaint dated 31 December 2019 and received 22 September 2020 and Mr Hanna's response to the HCCC dated 5 March 2020, the complaint by Ms Meaklim and Mr Hanna's response to the HCCC dated 1 February 2021, the file of the patient the subject of the codeine prescribing complaint and the complaint about the compounded sea sickness medication dated 3 June 2021. The documents included additional documents requested by the Council in its email to Mr Hanna dated 16 September 2021 and provided by him.
4. I also observe that when the proceedings were conducted on 13 September 2021, at the conclusion of the proceedings on that day, Mr Hanna asked when he would be notified of material the delegates requested he provide to them for consideration at the adjourned hearing.
5. Counsel for Mr Hanna, Mr T Flaherty, provided oral submissions and written submissions in support of the stay. He refers to the fact that Mr Hanna "was entitled to know precisely the basis of the Respondent's complaint against the Applicant, rather than the employed pharmacist who dispensed the medication".
6. It is also submitted that Mr Hanna was subject to an improper interrogation rather than an inquiry, and that the delegates concluded that the Applicant's indirect dispensing model was a "risky business" prior to conducting any real assessment of the model and how it worked. Criticism is also raised about the delegates' questioning of Mr Hanna about his family referring to it as "regrettable". At par 46 of Mr Flaherty's submissions, it is submitted: "The constant badgering and the insistence of providing specific answers to questions without any prior notice, creates the impression of the Respondent wishing to catch out the Applicant rather than trying to obtain a proper understanding of his practice."
7. In summary, it is submitted an examination of the transcript raises an issue of apprehended bias by the delegates and that the manner of the conduct of the hearing raises issues identified in Sharma v Minister for Immigration and Border Protection (2017) 256 FCR 1; [2017] FCAFC 227. Reference is also made to the seminal High Court authority on apprehended bias namely Ebner v The Official Trustee in Bankruptcy (2000) 205 CLR 337; [2000] HCA 63 at [6].
8. By contrast, in her submissions opposing the stay, Ms A Petrie, counsel for the Council, submits that the questions posed to Mr Hanna were appropriate, that there was a basis for the questions posed about acquiring more pharmacies and his wife's qualifications as a pharmacist were relevant. Ms Petrie also refers to the fact Mr Hanna "was legally represented" and significant issue was not taken by his solicitor in relation to the manner in which questions were posed by the delegates.
9. I commence by noting it is not my role in this application to make findings about the grounds of appeal now agitated in the s 159B appeal, but rather to give some consideration to the strength of the grounds and whether they are reasonably arguable.
10. I consider there is potential merit in some of the matters agitated in respect of the procedural fairness grounds, particularly in relation to the delegates' conclusions in respect of the codeine complaint when all Mr Hanna's evidence is assessed and not limited to his written response to the HCCC (see particularly the transcript of 13 September 2021 at pp 82 -83).
11. The assertions relating to the acquisition of further pharmacies also appear to have little or no relevance to the complaints and may suggest unnecessary or inappropriate questioning but at the end of the day that does not appear to have affected the delegates' decision making.
12. Although Ms Petrie submits that Mr Hanna was legally represented, I note a distinction must be drawn between the situation such as in disciplinary proceedings where a legal practitioner appears on behalf of a client, (see s 165J of the National Law) and the role of a support person at the s 150 hearing. I infer that it is the Council's position that Mr Hanna's then lawyer could have requested one or more of the council members to recuse themselves on the grounds of apprehended bias, or to object to the nature and range of the delegates' questioning.
13. Overall, I am satisfied that there is an arguable basis for some of the procedural fairness grounds.

Is condition 2 beyond power?

1. It is submitted on behalf of Mr Hanna that the Council has no power over how a pharmacy business may operate. It is noted that the National Law provides for the registration of pharmacy premises and broadly limits the persons who are able to have a pharmacy business.
2. As I discern it, the nub of this ground of appeal is encapsulated in par 37 of Mr Flaherty's submissions where he submits: "The business itself is not the practice of a health professional. A condition which imposed restricting management input or even attendance of the business is within the broad power granted to the Respondent, but a condition which aims to regulate a business is beyond power".
3. It is noteworthy that in other matters before this Tribunal that conditions have been imposed on a practitioner's registration restraining a pharmacist from compounding specified products (see Health Care Complaints Commission v Serafin [2021] NSWCATOD 11 by way of interlocutory order and in Health Care Complaints Commission v Bova [2017] NSWCATOD 28 at the conclusion of disciplinary proceedings). Although Ms Petrie submits these authorities are not relevant because they are not orders made under s 150, I am satisfied that the decisions appear to bolster the Council's position that a condition restraining a proprietor pharmacist from permitting any compounding or compounding particular products in any pharmacy he or she owns is not beyond power.
4. The response from the Council's monitoring officer in respect of condition 2 appears to support Mr Flaherty's submission referring as it does to this condition as "this relates to your pharmacies" implying the condition is one imposed on the pharmacy business and in particular Filled pharmacy.
5. However, as I noted in the interim stay reasons, it appears this condition is intended to be construed as an order restraining Mr Hanna, as proprietor of the two pharmacies which engage in compounding (Nile Pharmacy and Filled Pharmacy) from permitting any compounding occurring in those pharmacies. I accept the construction of this condition is a matter to be properly agitated at the hearing of the appeal.

Unreasonableness of the conditions imposed

1. The submissions of Mr Flaherty on this ground refer to a number of authorities, the correctness of which are not in doubt, about the requirement for a decision maker to reach a state of satisfaction as to a jurisdictional fact as the "precondition or criterion that enlivens the decision-maker's power or jurisdiction" (see Minister for Immigration and Multicultural Affairs v Esthetu (1999) 197 CLR 611; [1999] HCA 21 at [130]).
2. At pars 57 and 58 of his submissions Mr Flaherty submits: "In accordance with the statutory formulation of s150 of the National Law, a state of satisfaction, as a jurisdictional fact, is a threshold requirement to the Respondent's ultimate exercise of power under this section. 58. Acceptance of a 'state of satisfaction' as a jurisdictional fact gave rise to a new line of authority relating to 'reasonableness review' of such subjective jurisdictional facts, developed to ensure any degree of satisfaction required for the exercise of executive jurisdiction was 'arrived at reasonably."
3. The submissions also refer to Hossain v Minister for Immigration and Border Protection (2018) 264 CLR 123; [2018] HCA 34 at [34] cited in respect of the implied obligation for a decision maker to proceed reasonably in making the decision without undue interruptions.
4. The submissions assert the reasons are "essentially a recitation of excerpts from the transcript". It is asserted the quotes are selective "without any notice of the subject matter of the inquiry, coupled with speculation and assumptions" and that this methodology fortified Mr Hanna's view that the Council had prejudged the matter and displayed bias against him.
5. It is further asserted no reasons are given for the conclusions contained at [96] of the reasons. I note that [96] is in the following terms: "Given our concerns with Mr Tamer Hanna's actions relate to his oversight as a proprietor, his understanding of the legislation and guidelines concerning compounding and indirect dispensing using online platforms including patient counselling we believe that conditions listed below would be sufficient to mitigate the risk to the health and safety of the public at this time "
6. It is submitted that the reasons fail first, to set out what the actual risk is to the health and safety of the public, secondly to find the actual risk, "whatever this may amount to is unacceptable without the impositions of conditions or suspension" and thirdly that the "Reasons fail to provide any cogent basis as to why the Decision would be sufficient to mitigate the unacceptable risk (see Paragraph 97 of the reasons)" (Mr Flaherty's submissions, pars 68-70).
7. It is submitted that the Council's state of satisfaction was invalidly formed by not proceeding reasonably and undertaking the statutory task it was required to perform.
8. The submissions go on to address the conditions imposed. I perceive that Mr Hanna's unreasonableness grounds are directly related to the actual conditions. Mr Flaherty refers to the conditions being "counterintuitive, punitive and illogical".
9. In respect of the requirement that the practitioner undergo a performance assessment, reference is made to s 154A of the National Law. That provision is as follows: 154A Serious matters not to be referred for assessment [NSW] (1) A Council must not have the professional performance of a registered health practitioner assessed if a matter giving rise to the proposed assessment - (a) raises a significant issue of public health or safety that, in the Council's opinion, requires investigation by the Commission; or (b) raises a prima facie case of professional misconduct by the registered health practitioner, or unsatisfactory professional conduct by the registered health practitioner. (2) The matter must be dealt with as a complaint.
10. It is submitted that by imposing this condition the Council accepts Mr Hanna's conduct is below the disjunctive thresholds in s 154A and notwithstanding this proceeded to impose stringent conditions on Mr Hanna's registration.
11. It is further asserted that the Council notified the National Board to record the performance assessment condition on the practitioner's registration, prior to seeking agreement from the HCCC, and that action by reason of s 150(5) of the National Law has no effect. Section 150(5) of the National Law provides: Without limiting the conditions that may be imposed under subsection (1)(b), a Council may impose a condition requiring the registered health practitioner to undergo a performance assessment, but the condition has no effect unless the Commission agrees with the imposition of the condition.
12. Ms Petrie in her written submissions on this proposed ground of appeal asserts that Mr Hanna does not "properly identify" the basis on which he asserts the decision was legally unreasonable and "[t]he Council is accordingly unable to properly engage with the appellant's submissions in this regard". Ms Petrie submits the Tribunal should find this ground has limited prospects of success.
13. Mr Flaherty refers to the fact it is illogical to have imposed a condition on Mr Hanna's registration that he not engage in compounding when the Council acknowledges Mr Hanna does not compound in the practice of his profession.
14. It is also asserted that condition 2 is "wholly disproportionate" to the single issue concerning the sea-sickness product. It is submitted an appropriate condition could be such as that imposed in Health Care Complaints Commission v Serafin or Health Care Complaints Commission v Bova, namely a restriction on compounding particular products.
15. It is further asserted in considering the public interest the Council failed to consider the loss of employment, the financial devastation of a business, and the difficulties for patients to continue to receive medications. At par 81, the submissions record "This being in circumstances where the Filled Pharmacy has never been the subject of a complaint and was approved by the Respondent only months ago".
16. In her submissions on the conditions, Ms Petrie states that the decision was referred to the HCCC pursuant to s 150E. However the date of referral is not disclosed. The submissions note "[t]he pathway will be determined following consultation with the HCCC".
17. Ms Petrie in her submissions on behalf of the Council seeks to rebut the submissions made on behalf of Mr Hanna. For the purposes of these reasons where I am not determining the grounds of appeal, I note it is submitted that condition 1 was appropriate because of Mr Hanna's oversight role of the compounding carried out in his pharmacies regardless of whether he was actually compounding himself.
18. The submissions point out that the imposition of condition 2 was not based solely on the supply of the sea-sickness preparation but rather because of the Council's concerns about similarities with the prior 2018 complaint, Mr Hanna's lack of knowledge of the Board guidelines for proprietor pharmacists, his attitude to the 2018 complaint, lack of documentation for meetings at his pharmacy at Campbelltown or for his meetings at the pharmacies of which he is presently the proprietor. I pause to note the Campbelltown pharmacy is the pharmacy which Mr Hanna sold in 2016.
19. In further support of this submission Ms Petrie drew attention to the Council's reasons at [41] regarding lack of detailed documentary evidence of his employed pharmacists' training and that these pharmacists' skills were not the subject of a regular formal audit process. The submissions also note the Council's concerns that the Shire Pharmacy's website which referred to compounding was "misleading" given Mr Hanna's evidence that only two pharmacies offer compounding (Nile Pharmacy and Filled Pharmacy).
20. The submissions also draw attention to paragraphs of the Council's reasons which express concern about the lack of logging or documentation of staff training and concerns that Mr Hanna had not arranged for a Gap Analysis to be performed by an independent operator.

Failure to give reasons

1. Mr Flaherty's submissions raise similar issues to those raised in the interim stay application about the lack of reasons at the time of the imposition of the conditions and the failure to comply with s 176(3). He also refers to a practitioner being deprived of their ability to consider their position and in particular any application for a stay.

Consideration of the strength of the proposed grounds of appeal

1. I have already noted that the procedural fairness grounds are arguable grounds.
2. I accept that prima facie the condition imposing a performance assessment does not appear consistent with the conditions imposed on the basis that there is risk to the health and safety of the public.
3. I also accept there are arguable grounds of appeal in respect of condition 2 particularly whether the condition is ultra vires being a condition imposed on the pharmacy business not on the practitioner.
4. As earlier indicated, an examination of the transcript discloses that the delegates in their reasons did not refer to Mr Hanna's much fuller explanation and admissions about the codeine prescription complaint but relied only on his response to the HCCC.
5. I also accept there are arguable grounds of appeal on the basis of legal unreasonableness particularly having regard to the lack of consideration by the Council in assessing unacceptable risk in the context of the public interest by the failure to consider the disruption to members of the public in obtaining compounded medications in a timely manner, particularly when regularly dispensed by Nile Pharmacy or Filled Pharmacy, the loss of employment to 12 compounding technicians, 4 dispensing assistants, and 8 packers, together with 4 staff at Nile Pharmacy (see Mr Hanna's affidavit of 2 November 2021). I also note the reasons do not address the difficulties Mr Hanna explained in trying to organise a Gap Analysis because of Covid 19 restrictions. Further, the grounds of appeal directed to the legal unreasonableness of the breadth of condition 2 is not without some substance as are the grounds directed to the lack of compliance with s 154 and s 176 of the National Law.

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

1. I am not satisfied that Mr Hanna's appeal will be rendered nugatory if the stay is not granted. First, I note that at the hearing of the stay I identified that the appeal should be expedited and hearing dates have been fixed for 30 November and 1 December, 2021.
2. However, I do give some weight to the fact that without the stay being granted, or being granted on terms, that patients may be inconvenienced by having to get fresh scripts if repeat scripts cannot be dispensed in a timely manner. I also give some weight to the fact that Mr Hanna will have to make redundant a total of 28 staff members of whom 12 are compounding technicians. I accept that if there is an unacceptable risk to the health a safety of the public or unacceptable risk in the public interest there will, in many cases, be a punitive effect on a practitioner as a consequence but this fact is not a reason for a Council to fail to act if it is satisfied it is appropriate to do so.

Risk to the public if the stay is or is not granted?

1. The Council's reasons disclose concerns about Mr Hanna's response to the codeine dispensing. I have noted however that his response to questioning provided a very appropriate and detailed explanation of remedial steps undertaken since the complaint. However, given the terms of condition 3, he retains responsibility as the proprietor pharmacist for the proper dispensing of medications, other than compounded medications, in each pharmacy. Thus, it appears the delegates did not consider there was an unacceptable risk to the public in the dispensing of medications from those pharmacies by employed pharmacists for whose supervision Mr Hanna is responsible.
2. Mr Hanna has provided an undertaking that he will not prescribe the sea-sickness formula as part of his compounding operation if a stay is granted on terms. I note that the advertising of the compounded product and the fact the earlier complaint related to this product was understandably a matter for concern for the Council.
3. I also accept that the Council were concerned about Mr Hanna's association with Pilot and its prescribing doctors, particularly his reliance on the doctor's assessment of patient suitability for prescriptions for erectile dysfunction without face to face consultation with a patient, and in some circumstances such as the patient the subject of the complaint without, it was asserted, even a telephone or face to face electronic communication with the doctor. The conduct of the medical practitioners involved in this provision of patient care may be a matter requiring investigation by the Medical Council of New South Wales. The Council were clearly concerned that Mr Hanna's reliance on the model and the fact that a patient may, but did not have to, engage in "the secondary check" by consulting with the pharmacist dispensing either Viagra or a compounded product on a face to face basis posed a risk to the public.
4. I am unable, for the purposes of this stay application, to make a considered decision about the risks if any to the public as a result of all online dispensing of pharmaceuticals including compounded products. It is apparent from the websites referred to by the Council in their reasons that online dispensing is a mode of dispensing which is facilitated by medical practitioners providing electronic prescriptions and has no doubt been utilised in a wide-spread manner during the COVID 19 pandemic.
5. Thus, I conclude that risks to the public during the period of the stay may be mitigated by restraining Mr Hanna in his capacity of proprietor of Nile Pharmacy and Filled Pharmacy from compounding and supplying any compounded sea-sickness formula and from dispensing any compounded medication prescribed by any medical practitioner offering services through the Pilot app.
6. I also have regard to the fact that Mr Hanna has commissioned a Gap Analysis which has identified a number of recommended improvements to processes at Nile Pharmacy and Filled Pharmacy. I take into account that the Council are critical such a Gap Analysis was not conducted by Medisca. Mr Hanna deposes in his affidavit sworn 2 November 2021 that he had been trying to arrange a Gap Analysis by Medisca but had not been able to do this because of the restrictions on face to face visits because of the pandemic and that he explained this at the s 150 hearing. I also note the concerns in the Council's submissions that the Gap Analysis conducted by Verity occurred after the conditions were imposed so that no compounding was in progress at the time of the analysis.
7. However, much of the Council's concerns focussed on lack of documentation of process and appraisals, as well as checking of instrumentation. These matters are covered in the Verity assessments. Thus, I am satisfied any stay granted should be subject to compliance with these conditions.

Where does the balance of convenience fall?

1. I commence by noting that I received correspondence on 8 November 2021 from the Council and Mr Hanna's lawyers about conditions attaching to any stay granted. This was in response to a direction I made at the conclusion of hearing oral submissions on the stay application.
2. It is noteworthy that the Council submit there is no power to grant a stay on conditions and oppose any stay on such basis. Although that is the Council's primary position the "fallback" position is that the only condition which should be stayed is the performance assessment condition.
3. Mr Hanna's lawyers submit that a stay should be on terms that he and any pharmacy he owns be restrained from compounding the sea-sickness medication and complying with the Verify recommendations as soon as practicable.

Conclusions

1. An overall assessment of the matters agitated on this stay application are quite finely balanced. I do not consider that the balance of convenience falls in favour of a total stay of the conditions imposed by the Council. However, having regard to the confined nature of the three complaints, the arguable grounds of appeal proposed to be agitated, and the actual or potential adverse impact on the ability of patients to obtain compounded medications in a timely manner and the loss of employment to the employees of Nile Pharmacy and Filled Pharmacy, I conclude that the balance of convenience falls in favour of a stay being granted on conditions.
2. As noted above, the parties were afforded an opportunity to provide proposed conditions on the basis I may consider a stay on terms to be appropriate. Notwithstanding the Council argue that a stay cannot be imposed subject to conditions, I note that this is not the position which has been adopted in other recent Tribunal decisions (see Mapa v Medical Council of New South Wales; Knowles v Medical Council of New South Wales [2019] NSWCATOD 46). As presently advised, in conformity with those decisions, I accept that s 165L(1) provides the necessary source of power to impose conditions as it relates to "any proceedings under this Law".

Expedition

1. I note that this stay is for a limited period as I have already granted expedition of this appeal.

Orders 1. Pending further order, the conditions imposed on the registration of Tamer Hanna by the Pharmacy Council of New South Wales on 13 October 2021 are stayed subject to the following conditions: 1. Tamer Hanna must not allow the supply, dispensing or compounding of any of the following products at any pharmacy in which he has a financial interest: 1. any compounded sea-sickness formula including the formula referred to in the reasons for decision of the Pharmacy Council of New South Wales dated 1 November 2021. 2. any compounded medication prescribed by a medical practitioner via the Pilot app for erectile dysfunction. 1. Tamer Hanna must do all things and take all steps necessary to implement each and every recommendation made by Verity in its Gap Analysis reports dated 2 November 2021 in respect of Filled Pharmacy Pty Ltd trading as Filled Pharmacy and Nile Compound Chemist Pty Ltd trading as Nile Compounding Chemist as soon as practicable. 1. The costs of the interim stay application and 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: 10 November 2021