Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Health Care Complaints Commission v Conte [2021] NSWCATOD 37 Hearing dates: 25 – 26 February 2021 and by written submissions dated 8 March 2021 Date of orders: 08 April 2021 Decision date: 08 April 2021 Jurisdiction: Occupational Division Before: The Hon F Marks, Principal Member R Benda, Senior Member K Carter, Senior Member M Ficarra, General Member Decision: (1) The Respondent is reprimanded. (2) The following conditions are imposed on the Respondent's registration: General conditions A. The Respondent must not work as a pharmacist in charge for a period of 24 months or such longer period of time as determined by the Pharmacy Council of New South Wales (the Council). B. The Respondent must not work as the sole pharmacist on duty for a period of 24 months or such longer period of time as determined by the Council. C. The Respondent must not possess, supply, dispense, administer or manufacture any substance detailed in Schedule 8 of the NSW Poisons List (drug of addiction, derivative or compound medication), Schedule 4B (special restricted substance, derivative or compound medication) or Schedule 4D (prescribed restricted substance, derivative or compound medication), or any substance detailed in an equivalent list of any other Australian State or Territory, for a period of 24 months or such longer period of time as determined by the Council. Mentoring conditions D. The Respondent is to undergo mentoring by an experienced pharmacist approved by the Council as follows: i. The Respondent is to nominate to the Council an experienced pharmacist who is unrelated to him, is not a present employee at the Booth Street Pharmacy, Annandale (Pharmacy), and is not a previous employee at the Pharmacy, other than Mr Branko Radojković, to act as his professional mentor (Mentor). ii. The mentoring relationship is to continue for a period of 24 months from the date of the Mentor's appointment, or such longer time as determined by the Council, and at the frequency determined by the Council. iii. The Respondent is to authorise the Mentor to provide reports to the Council at the frequency determined by the Council and to inform the Council within one business day if there is any concern about the Respondent's professional conduct or personal well-being. iv. The Respondent is to authorise the Mentor to report to the Council about his professional conduct and personal well-being at the conclusion of the 24-month period of the mentoring relationship. v. The Respondent is to meet all costs associated with the mentoring conditions. vi. As soon as practicable after the Mentor is appointed by the Council, the Respondent must provide the Mentor with a copy of the decision made by the Tribunal. Auditing conditions E. The Respondent is to: a. apply for Quality Care Pharmacy Program (QCPP) accreditation within 4 weeks of the date of these orders; b. obtain QCPP accreditation for the Pharmacy within 6 months of the date of these orders or such longer period as the Council may allow upon request by the Respondent (such request to be accompanied by submissions as to why the period should be extended); and c. maintain QCPP accreditation for the Pharmacy for a period of at least three years from the date of the accreditation being granted. F. The Respondent is to undergo external auditing as follows: i. The Respondent is to nominate an appropriate external auditor to be approved by the Council (Auditor) for the purpose of conducting regular audits of the Respondent and the Pharmacy as set out below (Audits). ii. The Audits are to focus on (but not be limited to) compliance by the Respondent and the Pharmacy with the Poisons and Therapeutic Goods Act 1966 (NSW), the Poisons and Therapeutic Goods Regulation 2008 (NSW), the Health Practitioner Regulation National Law (NSW) (the National Law), the Health Practitioner Regulation (New South Wales) Regulation 2016 (NSW), and codes or guidelines approved by the Pharmacy Board of Australia pursuant to s 41 of the National Law (the Standards). iii. The Audits are to be conducted in the manner and at the frequency determined by the Council, for a period of at least two years. iv. The Respondent is to authorise the Auditor to provide reports to the Council at the frequency determined by the Council and to inform the Council within one business day if there is any concern about the Respondent or the Pharmacy meeting the Standards. v. The Respondent is to meet all costs associated with the auditing conditions. vi. As soon as practicable after the Auditor is appointed by the Council, the Respondent must provide the Auditor with a copy of the decision made by the Tribunal. Compounding conditions G. The Respondent must not allow any aseptic or other form of complex compounding (as defined in clause 4 of the "Guidelines on compounding of medicines" made by the Pharmacy Board of Australia) to take place in any pharmacy in which he has a financial interest, or participate in any such compounding. H. The Respondent must not allow the compounding or manufacturing of any preparation containing testosterone to take place in any pharmacy in which he has a financial interest. I. The Respondent is not to keep, and is to ensure that there are not kept, at the Pharmacy any substances that are not required for the ordinary operation of the Pharmacy. (3) The appropriate review body for the purposes of Part 8, Division 8 of the National Law is the Pharmacy Council of New South Wales. (4) The Respondent is to pay the Applicant's costs, assessed in default of agreement. Catchwords: HEALTH — professional registration and discipline — unsatisfactory professional conduct — pharmacist convicted of importation of regulated substances without permit — complaint confined to allegation of unsatisfactory professional conduct — found guilty of unsatisfactory professional conduct — cancellation or suspension not appropriate protective order in circumstances — conditions imposed on registration — other protective orders made Legislation Cited: Health Practitioner Regulation National Law (NSW), ss 3A, 130, 139B, 144, 149, 149A, 149C, 150, 150A Crimes (Sentencing Procedure) Act 1999 (NSW), s 22(1A) Cases Cited: Health Care Complaints Commission v Do [2014] NSWCA 307 Texts Cited: Pharmacy Board of Australia, "Guidelines on compounding of medicines" (March 2015) Category: Principal judgment Parties: Health Care Complaints Commission (Applicant) John Peter Conte (Respondent) Representation: Counsel: D Fuller (Applicant) Dr P Dwyer (Respondent) Solicitors: Health Care Complaints Commission (Applicant) Catherine Henry Lawyers (Respondent) File Number(s): 2020/00244096 Publication restriction: Non-publication order made with respect to the name of any patient or former patient of the respondent or any information which may tend to identify any such person. Reasons for decision Introduction 1. In these proceedings the applicant, Health Care Complaints Commission, has alleged that the respondent John Peter Conte is guilty of unsatisfactory professional conduct under section 139B of the Health Practitioner Regulation National Law (NSW) ("the National Law") in his practice of the profession of pharmacist. The proceedings are constituted by an Amended Complaint filed at the commencement of the hearing which is in the following terms: The Health Care Complaints Commission of Level 12, 323 Castlereagh Street, Sydney NSW, having consulted with the Pharmacy Council of New South Wales in accordance with sections 39(2) and 90B(3) of the Health Care Complaints Act 1993 and section 145A of the Health Practitioner Regulation National Law (NSW) ("the National Law") HEREBY COMPLAINS THAT John Peter Conte ("the practitioner") of (address deleted) being a pharmacist practitioner registered under the National Law, BACKGROUND TO ALL COMPLAINTS On 21 November 2000, the practitioner upon completion of a Bachelor of Pharmacy from the University of Sydney, was registered as a Pharmacist in NSW. In 2007, after working in a number of private pharmacies, the practitioner purchased and became the proprietor of the Booth Street Pharmacy in Annandale, NSW ("the Pharmacy"). COMPLAINT ONE Pursuant to section 144(a) of the National Law the practitioner has been convicted of criminal offences in New South Wales. PARTICULARS OF COMPLAINT ONE 1. On 21 February 2019, in the District Court of NSW, Sydney, the practitioner pleaded guilty to two offences of import of a prohibited import contrary to section 233BAA(4) of the Customs Act 1902 (Cth): a) on 3 April 2016, he intentionally imported prohibited tier 1 goods, namely 2.5kg of Testosterone Benzoate, being reckless to the fact that the goods were tier 1 goods, and their importation was prohibited without a permit; and b) on 28 April 2016, he intentionally imported prohibited tier 1 goods, namely 5kg of Testosterone Enanthate, being reckless to the fact that the goods were tier 1 goods, and their importation was prohibited without a permit. 2. The practitioner was convicted of both offences. A judge of the District Court imposed an aggregate sentence pursuant to section 20(1)(a) of the Crimes Act 1914 (Cth), that the practitioner be released without passing sentence by recognizance, upon giving security in the sum of $100.00, without sureties, and that he comply with a condition that he enter into a good behaviour bond for a term not exceeding 12 months. COMPLAINT TWO is guilty of unsatisfactory professional conduct under section 139B(1)(b) of the National Law in that he has contravened section 130(1) of the National Law: PARTICULARS OF COMPLAINT TWO 1. The practitioner failed to notify the National Board that he had been charged before a NSW Court with offences punishable by 12 months imprisonment or more, within seven days of becoming aware of the fact: a) On 21 May 2016, the practitioner had been charged with two offences of import of a prohibited import contrary to section 233BAA(4) of the Customs Act 1902 (Cth). b) On 18 August 2018, the practitioner had been charged with failing to comply with an order under section 3LA(2) of the Crimes Act 1914 (Cth), contrary to section 3LA(5) of the Act. 2. The practitioner failed to notify the National Board that he had been convicted before a NSW Court with offences punishable by 12 months imprisonment or more, within seven days of becoming aware of the fact: a) On 21 February 2019, the practitioner had been convicted of two offences of import of a prohibited import contrary to section 233BAA(4) of the Customs Act 1902 (Cth). 1. In its original form the Complaint contained an allegation that the respondent was guilty of professional misconduct under section 139E of the National Law. The effect of the amendment was to delete this allegation. 2. The respondent has admitted that he is guilty of each of the complaints brought against him and that his conduct constitutes unsatisfactory professional conduct under the National Law. 3. The parties agreed that the hearing should cover both Stage 1 matters, namely whether the respondent is guilty of the misconduct as alleged, and, if so, in Stage 2, what protective orders should be made. The factual background 1. Both parties tendered into evidence documentary material, and the respondent gave oral evidence. We shall refer to such portions of this evidentiary material as is relevant to our decision, which is confined by the Complaint to a consideration of the offences of which the respondent has been convicted, a determination whether the respondent is guilty of unsatisfactory professional conduct and what consequential protective orders should appropriately be made. The narration which follows is based on that evidentiary material. 2. We add for completeness that in determining any factual issue necessary for the determination of the proceedings we will adopt the in-principle approach exemplified by the well-known Briginshaw principle. That is, in general terms, we must be "comfortably satisfied" on the balance of probabilities that the fact has been established. Of course, this approach is not relevant when considering whether the respondent has discharged any burden of proof with respect to any matter, where the normal civil standard applies. 3. The respondent has been registered as a pharmacist since 21 November 2000. He commenced working in a community pharmacy in 1998. In 2007 he purchased a pharmacy which he relocated and is the Booth Street pharmacy referred to in the Complaint. The respondent continues to be the sole proprietor of this pharmacy. 4. By way of background, the respondent said that while practising pharmacy he had acquired an interest in compounding non-sterile medication. In an interview conducted by delegates of the Pharmacy Council of NSW on 4 October 2016, during proceedings taken under section 150 of the National Law, the respondent said that he was compounding products such as dehydroepiandrosterone, melatonin and creams. He said he had undertaken some training and that he liked compounding: "I quite like making things and experimenting and that sort of thing." When discussing the proposal to compound testosterone products the respondent said when he had developed them he was going to start canvassing "a lot of the aged doctors, cosmetic surgeons… a lot of them prescribe… low dose Pro forma and low-dose testosterone for their elderly patients." He was also looking to develop a product which contained a number of different substances within the one capsule. He said: "I was looking at potentially giving blood pressure, a statin, an antidepressant, you know, a lot of these compounds that are very common, very commonly prescribed with, of course, consideration taken into, you know, physio-chemical compatibility, you know, if it is chemically stable together, but I – so that was a couple of years ago." 1. Conditions were imposed on his registration by the Pharmacy Council of NSW on 13 July 2011. Between 13 July 2011 and 8 February 2012 the respondent was required to attend for regular treatment by a general practitioner and a treating psychiatrist as well as to attend for random Urine Drug Testing. He was required to attend to further requirements directed by the Council. Between 8 February 2012 and 12 July 2012 these conditions were amended by the Council inter alia to require thrice weekly Urine Drug Testing. 2. On 4 October 2016 delegates of the Pharmacy Council conducted a hearing under section 150 of the National Law in which the respondent participated. Pursuant to Orders made by those delegates, the Council imposed conditions on the respondent's registration effective from 6 October 2016, which remain current. Those conditions prohibit the respondent from working in a pharmacy as a pharmacist in charge; preclude him from remaining on pharmacy premises except during opening hours and only whilst an employed pharmacist is on the premises; require him to relinquish all keys, access codes, smartcards or access cards for any pharmacy in which he has a financial interest; prohibit him from possessing, supplying, dispensing, administering or manufacturing any substance detailed in Schedule 8 of the NSW Poisons List (which includes drugs of addiction, derivative or compound medication) or in Schedule 4D, or any substance detailed in an equivalent list of any other Australian State or Territory; and prohibit him from allowing the compounding or manufacturing of any preparation containing testosterone in any pharmacy in which he has a financial interest. These conditions were further amended on 17 November 2017 by the Pharmacy Board of Australia to provide, in effect, that the conditions imposed by the Council applied throughout Australia. These amended conditions remain current. 3. The respondent sought a review of the conditions imposed by the Pharmacy Council under section 150A of the National Law. Delegates of the Council conducted a hearing on 7 May 2019 in which the respondent participated. At the conclusion of the hearing the delegates refused to amend the conditions. 4. During the course of that hearing the respondent told the delegates that he would seek to have the pharmacy reaccredited with the Quality Care Pharmacy Program (QCPP). He said that he had allowed the accreditation to lapse because of uncertainty about the outcome of the criminal proceedings "and the prevailing political environment". Reasons published by the delegates indicated that they expressed concern to the respondent that he had not taken advantage of his restrictive practice conditions and applied himself by seeking reaccreditation for the pharmacy. They noted that the respondent had assured them "that he would do so now having received a favourable outcome from his court case". (We shall discuss accreditation with QCPP later in these reasons.) 5. The delegates had also queried the respondent concerning his current CPD activities. He informed them that he had completed "one online module via the AJP this CPD year". The delegates noted that the respondent had little understanding of the difference between Groups 1 and 2 CPD, had not prepared a CPD plan for that current year "and appeared not to understand its relevance or importance." In addition, the delegates observed that the respondent did not have a written dispensing procedure for his pharmacy; he did not have a PDL dispensing procedure wall chart or similar written procedure, but indicated that he intended to develop a written dispensing procedure. 6. The circumstances surrounding the detection of the importation of the prohibited substances referred to in Complaint One are revealed by copies of documents provided through the Australian Federal Police. The prohibited goods were detected by the Australian Border Force and were referred for analysis. The goods were seized by officers of the Australian Federal Police, the respondent was arrested, his pharmacy premises were searched, and the respondent provided information to the arresting officers. A Statement of Facts notes that the respondent had no prior convictions, although he had been detected "with steroids at Sydney Airport on 1 November 1995". 7. The offence referred to in Particular 1(b) of Complaint Two arises from a failure by the respondent to give Australian Federal Police officers access to an iPhone 6 by providing them with the relevant passcode. 8. In his record of interview with officers of the Australian Federal Police the respondent said that he was importing the testosterone for the purpose of conducting experiments to ascertain whether he could compound a product which could then be prescribed by medical practitioners. He said that, in particular, he was experimenting with dissolving the testosterone in certain oils rather than in water so that it could become a more effective injectable. The respondent said that he did not know that he had to acquire a permit to import testosterone and thought that he was entitled to do so by reason of his registration as a pharmacist. He said that he had been informed about this in a casual conversation some years previously with a person who was involved "in regulatory affairs" who had told him that it was permissible to import testosterone for "cosmetic" purposes. In the course of his evidence in these proceedings the respondent said that he made no enquiries about the requirement for a permit to import the substances from Australian Customs or the NSW Department of Health, and he did not conduct any general Internet search about the matter using a search engine. 9. The respondent also informed these officers that he thought that there was a potential market for compounding testosterone products and that he was also looking to become involved in growth hormones which "would have been massively lucrative". 10. The respondent said that he had also imported the testosterone for his own use. At first the respondent said that he did not possess a prescription for this medication, but subsequently produced one handwritten prescription from Dr J Capelhorn dated 6 February 2016 for 10ml of a testosterone compound. In his evidence in these proceedings the respondent prevaricated between stating that he had held a prescription for his own use of testosterone, but later changed his evidence that the substance had not been dispensed "through the pharmacy" and he did not put a label on it. He then said that he did not use testosterone without a prescription, but conceded that a prescription for 250mg/ml of 10ml would have produced 10 doses only. 11. Documentation seized by the Australian Federal Police indicates that the invoices for the seized imported goods showed addresses for the consignors in China, and that the goods were falsely labelled Vitamins B6 and B1. The respondent said that he had no control over the manner in which the consignors described the goods. Furthermore, the respondent produced for the purpose of this hearing an analysis of 11 glass vials containing white powders, produced for him by the UNSW Analytical Centre. However, the analysis is dated 23 October 2014, which considerably predates the substances imported by the respondent which are the subject of these proceedings. 12. During the course of his evidence before us the respondent was taken to a Statement of Facts made by him for the purpose of the criminal proceedings. In describing the items which had been seized by the Australian Federal Police, the respondent had included a Tupperware container containing 2 clip seal bags of white powder totalling approximately 2kg and testing positive to testosterone, with a label from the Chinese exporter describing the items as Vitamin B6. The respondent said that this statement was incorrect. He said that the 2kg of white powder were in fact unlabelled and an officer had put a label, which had fallen off another package, on top of them. The respondent said the 2kg of powder was in fact testosterone, but it was stock from a previous purchase, but not from the same Chinese exporter. He said that he did not correct this statement and that there were, in fact, a number of "misunderstandings" in the police charge sheets. The respondent proffered no explanation as to why he would have been storing 2kg of unlabelled testosterone in the bottom of the pharmacy refrigerator, in circumstances where none of his staff, both professional and otherwise, would have known what the substance really was. In reality, the respondent was in possession of 2kg of testosterone and if he had been entitled to import the quantity which is the subject of these proceedings he would have had a total of 9.5kg of testosterone for experimentation. 13. We note that the evidence given before us that the 2kg of an unlabelled substance was testosterone from a previous order is seemingly inconsistent with information which the respondent gave to the delegates of the Pharmacy Council during the course of the section 150 proceedings when he said that "what the police walked away with" was actually "mainly compounds of substances such as finasteride, dutasteride… amlodipine, simvastatin and atorvastatin". 14. The respondent insisted that he only provided testosterone and other restricted substances to customers of his pharmacy against a prescription issued by a medical practitioner. There is no evidence to the contrary. 15. In the course of several statements given for the purpose of the criminal proceedings and these proceedings the respondent said that he operated as a compound chemist and was "the first point of contact for emergency compounding for the paediatric department at the Royal Prince Alfred Hospital." As it transpired, this is a service which he provided when the dispensing pharmacist at that hospital was not working over weekends. 16. In these proceedings the respondent asserted that he would have been able to have validly imported the substances which are the subject of the criminal proceedings if he had known of the requirement to obtain a permit. In support of this submission the respondent tendered into evidence a Permit to Import dated 1 July 2016. This permit allowed the respondent to import one pack of testosterone benzoate of 500g, to be imported on or after 1 July 2016 and before 1 January 2017. In his statement the respondent said that he had forwarded an email to the NSW Government Department of Health to enquire whether he would have been approved for the importation of 5kg of that substance. He said that the Department responded that its office "does not set any limits for importation" and that he believed "had I applied for a permit at the time I was purchasing testosterone, and for the quantities I purchased it in, it would have been approved." However, the email communication chain upon which the respondent relied for this assertion was in fact from the Australian Government Department of Health, which indicated that that office does not set any limits for importation but "End User Declarations are also supplied to local law enforcement. The State Health Department is ultimately who you will need to justify the quantity to, as they are the ones who conduct site inspections." The respondent has not furnished any evidence to justify his assertion that he would have been able to make successful application in the name of his pharmacy to import the substances and the quantity thereof which are the subject of these proceedings. 17. In cross examination the respondent agreed with an opinion of Dr Helen Benson, an expert retained by the applicant, that the highest recommended dose of testosterone for androgen deficiency in men is 250mg by intramuscular injection every 2 weeks and this would mean that the 7.5kg of testosterone imported would be equivalent to approximately 30,000 doses. The respondent endeavoured to explain the large quantity imported by him as involving a degree of wastage because he was experimenting with mixing it with various oils, and it had a shelf life of 2 years. 18. We have been provided with the sentencing remarks of his Honour Judge Maiden in the District Court of New South Wales made on 21 February 2019. In the course of delivering his remarks Judge Maiden, when referring to the substances which are the subject of the criminal proceedings, said: "The legislation for this drugs [sic] is important, because of the dangers that the unauthorised or unqualified use of the drug itself poses a danger [sic] to any person who may use it. In this regard, I find that the drug was to be used within the legal application in the pharmacy of the offender, and that he had approval to use the drug by virtue of a prescription by his general practitioner. This, in my mind, does separate the matter from a matter which would be provided to a person who would not have the authority to dispense the drug. As such, I find that the question of general deterrence is not relevant to the extent it would be, if the person was not qualified as a pharmacist." 1. His Honour then went on to note the restrictions imposed on the respondent's registration. Furthermore, his Honour found that "[A]lthough there was an intention to use the drug in the pharmacy practice, and that was to result in hopefully profit in part of the compounding work of the pharmacy. It could not be said that there was any greater financial gain than that that would ordinarily be involved in the practice of the pharmacy… I do not accept that there was any other benefit to be received by him, other than in the ordinary course of his legal operation of the pharmacy business." 1. Counsel for the respondent urged that we take into account these sentencing remarks in determining the appropriate protective orders to be made in the circumstances of these proceedings. We shall return to this aspect of the matter, but we wish to observe that we respectfully disagree with the sentencing remarks to the extent that they embrace the possession of the substances by the respondent as being within his practice as a pharmacist. In reality, he may have held a prescription for a tiny amount of testosterone (which was probably not processed according to the confusing evidence given by the respondent) but the remainder of the testosterone which the respondent sought to import could not have been used for the purpose of the pharmacy business in the absence of validly-issued prescriptions by a registered health practitioner, which, on the evidence, did not exist. In reality, the respondent was seemingly considering creating a pharmaceutical manufacturing business, a project which has distinct and separate features from the regulatory regime which applies to pharmacies. 2. Indeed, the "Guidelines on compounding of medicines" issued by the Pharmacy Board of Australia restrict the preparation of compounded medicine to circumstances where, inter alia: 1. an appropriate commercial product is unavailable; 2. a commercial product is unsuitable (e.g. if a patient experienced an allergy to an excipient in the commercial product); or 3. when undertaking research sanctioned by a recognised human research ethics committee. 1. These Guidelines also contain detailed provisions describing the professional practice profile for pharmacists undertaking complex compounding and the necessity to demonstrate competence to undertake that process. 2. As we have already pointed out, the respondent's asserted intended use for this large quantity of testosterone could not possibly be undertaken in the course of the operation of the pharmacy in the absence of any prescriptions against which any compounded product could be dispensed. The expert report 1. The applicant retained Dr Helen Benson, an expert and experienced pharmacist, to provide an opinion concerning the respondent's conduct. She was provided with a great deal of background information, and after considering this information concluded that: 1. the respondent, as an experienced pharmacist, should have been aware that because testosterone was a Schedule 4 restricted substance it would have been likely to have strict import requirements imposed. She observed that this conduct fell significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience and she was strongly critical of it; 2. in concluding that 7.5kg of testosterone would have produced the equivalent of 30,000 clinical doses, the stockpiling of such a large amount of a restricted substance without legitimate orders or prescriptions caused the respondent's conduct to fall significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience and she was strongly critical of it; 3. the respondent should have been aware that he required special authorisation for the substance because he was importing it other than as part of the usual practice for pharmacist proprietors. She said this conduct fell significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience and she was strongly critical of it. The statutory provisions governing these proceedings 1. These proceedings are governed by the National Law. Relevantly, section 144 provides as follows: 144 Grounds for complaint about registered health practitioner [NSW] The following complaints may be made about a registered health practitioner— (a) Criminal conviction or criminal finding A complaint the practitioner has, either in this jurisdiction or elsewhere, been convicted of or made the subject of a criminal finding for an offence. (b) Unsatisfactory professional conduct or professional misconduct A complaint the practitioner has been guilty of unsatisfactory professional conduct or professional misconduct. (c) Lack of competence A complaint the practitioner is not competent to practise the practitioner's profession. (d) Impairment A complaint the practitioner has an impairment. (e) Suitable person A complaint the practitioner is otherwise not a suitable person to hold registration in the practitioner's profession. 1. We note that Complaint One is confined to the matters covered in section 144(a), namely the criminal conviction for the offences set out in the Particulars of that complaint. The allegation that the respondent is guilty of unsatisfactory professional conduct is confined to the circumstances set out in Complaint Two. 2. Section 130(1) required the respondent, as a registered health practitioner, to notify the Pharmacy Board of Australia of certain matters. Relevantly, they are 130 Registered health practitioner or student to give National Board notice of certain events (1) A registered health practitioner or student must, within 7 days after becoming aware that a relevant event has occurred in relation to the practitioner or student, give the National Board established for the practitioner's or student's health profession written notice of the event. (2) A contravention of subsection (1) by a registered health practitioner or student does not constitute an offence but may constitute behaviour for which health, conduct or performance action may be taken. (3) In this section— relevant event means— (a) in relation to a registered health practitioner— (i) the practitioner is charged, whether in a participating jurisdiction or elsewhere, with an offence punishable by 12 months imprisonment or more; or (ii) the practitioner is convicted of or the subject of a finding of guilt for an offence, whether in a participating jurisdiction or elsewhere, punishable by imprisonment; or … 1. The respondent concedes that he was in breach of section 130(1) in that he failed to notify the National Board of his conviction and the fact that he had been charged with the offences particularised in Particular 1 of Complaint Two. 2. The Complaint alleges, and the respondent concedes that he is guilty of unsatisfactory professional conduct as defined in section 139B of the National Law, the relevant parts of which are as follows: 139B Meaning of "unsatisfactory professional conduct" of registered health practitioner generally [NSW] (1) Unsatisfactory professional conduct of a registered health practitioner includes each of the following— (a) Conduct significantly below reasonable standard Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of the practitioner's profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. (b) Contravention of this Law or regulations A contravention by the practitioner (whether by act or omission) of a provision of this Law, or the regulations under this Law or under the NSW regulations, whether or not the practitioner has been prosecuted for or convicted of an offence in respect of the contravention. … (l) Other improper or unethical conduct Any other improper or unethical conduct relating to the practice or purported practice of the practitioner's profession. 1. Significantly, the amendment made to the Complaint not only deleted any charge that the respondent was guilty of professional misconduct but also deleted an allegation in Complaint Two that the respondent had engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy. Accordingly, the applicant has confined the allegation of unsatisfactory professional conduct to that which is set out in section 139B(1)(b) of the National Law. 2. Accordingly, our consideration of the respondent's misconduct for the purpose of the Stage 1 part of this hearing is confined to the matters set out above. Findings with respect to the Complaints made against the respondent 1. Having regard to the evidence given in the proceedings and the admissions made by the respondent, we formally find that the respondent is guilty of the matters referred to in Complaints One and Two and the Particulars of those complaints. Protective orders 1. It is now necessary to consider what protective orders should be made consequent upon the findings which we have made. They are to be found in Division 3, Subdivision 6 of the National Law. 149 Powers may be exercised if complaint proved or admitted [NSW] The Tribunal may exercise any power conferred on it by this Subdivision in relation to a registered health practitioner or student if— (a) it finds the subject-matter of a complaint against the practitioner or student to have been proved; or (b) the practitioner or student admits to it in writing to the Tribunal. 1. Included within Subdivision 6 is section 149A(1): 149A General powers to caution, reprimand, counsel etc [NSW] (1) The Tribunal may do any one or more of the following in relation to the registered health practitioner— (a) caution or reprimand the practitioner; (b) impose the conditions it considers appropriate on the practitioner's registration; (c) order the practitioner to seek and undergo medical or psychiatric treatment or counselling (including, but not limited to, psychological counselling); (d) order the practitioner to complete an educational course specified by the Tribunal; (e) order the practitioner to report on the practitioner's practice at the times, in the way and to the persons specified by the Tribunal; (f) order the practitioner to seek and take advice, in relation to the management of the practitioner's practice, from persons specified by the Tribunal. 1. In addition, we are empowered to either suspend or cancel the registration of the respondent by reason of section 149C(1)(c). For completeness we set out the provisions of this subsection in full. 149C Tribunal may suspend or cancel registration in certain cases [NSW] (1) The Tribunal may suspend a registered health practitioner's registration for a specified period or cancel the registered health practitioner's registration if the Tribunal is satisfied— (a) the practitioner is not competent to practise the practitioner's profession; or (b) the practitioner is guilty of professional misconduct; or (c) the practitioner has been convicted of or made the subject of a criminal finding for an offence, either in or outside this jurisdiction, and the circumstances of the offence render the practitioner unfit in the public interest to practise the practitioner's profession; or (d) the practitioner is not a suitable person for registration in the practitioner's profession. 1. The applicant sought an order that the respondent's registration be cancelled. 2. The nature of protective orders and the circumstances in which they should be made have been conveniently summarised in the New South Wales Court of Appeal in Health Care Complaints Commission v Do [2014] NSWCA 307 ("HCCC v Do"). Meagher JA (Basten and Emmett JJA agreeing) said: "[35] The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It includes protecting the public from the similar misconduct or incompetence of other practitioners and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining those standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operates both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise. [36] In Law Society of New South Wales v Foreman (1994) 34 NSWLR 408 Mahoney JA described (at 441) the scope of the objective of protecting the public interest in the context of disciplinary proceedings against a solicitor as follows: 'The protection of the public has been described as, for example, the primary purpose or primary object of such proceedings: ... In the relevant sense, the protection of the public is in my opinion not confined to the protection of the public against further default by the solicitor in question. It extends also to the protection of the public against similar defaults by other solicitors and has, in this sense, the purpose of publicly marking the seriousness of what the instant solicitor has done. But, in my opinion, it would be wrong to confine the objects of disciplinary proceedings and the purposes to be achieved by the orders made in them strictly to matters of this kind. Those purposes and objectives have traditionally been seen as having a wider operation. In the end, the question to be determined is whether the solicitor is a fit and proper person to be a solicitor of the Court and the orders to be made are to be directed to ensuring that, to the extent she is not, her practice is restricted.' [37] In Herron v McGregor (1986) 6 NSWLR 246 McHugh JA referred more briefly to the same consideration (at 258): 'It is, of course, of fundamental importance to bear in mind the public interest in disciplining doctors who are guilty of professional misconduct. In many cases the protection of the public and the maintenance of professional standards requires that the names of doctors be removed from the register. However, it is present fitness to practise which is the principal and ultimate issue of public interest.'" 1. We note that no allegation is made in the Amended Complaint that the respondent is not competent to practise as a pharmacist, that he is guilty of professional misconduct, or is not a suitable person for registration as a pharmacist. Our consideration of whether it is appropriate to suspend or cancel the respondent's registration is governed by section 149C(1)(c). 2. Both limbs of this subsection must be satisfied, and it is necessary that we consider whether the circumstances of the offences render the respondent unfit in the public interest to practise as a pharmacist. This leads to a consideration of what the "circumstances of the offences" are. This is a phrase which is commonly encountered in criminal jurisdictions. For example, section 22(1A) of the Crimes (Sentencing Procedure) Act 1999 provides that a court may impose a lesser penalty under that section which must not be "unreasonably disproportionate to the nature and circumstances of the offence." In criminal cases a distinction is often made between the objective and subjective circumstances of an offence. For present purposes we take the view that, in considering the circumstances of the offences, we may take into account the objective nature of the offences themselves, as well as the subjective matters pertaining to the respondent. This is because we are obliged to consider the circumstances of the offences as they impact upon his fitness in the public interest to practise his profession as a pharmacist. Seen in this way, the circumstances of the offences will also embrace a consideration of their nature, notwithstanding that the subsection contains a reference to the circumstances of the offences without any mention of their "nature". 3. Having regard to what is known of the factual background against which the offences were committed, we make the following comments: 1. prima facie both offences arose out of the one course of conduct. They are confined to attempts to import regulated substances without obtaining a permit as required by law for use by the respondent in circumstances discussed below; 2. there is no evidence that the respondent was aware of the requirement to obtain a permit; 3. however, based on the expert opinion of Dr Benson, a person in the position of the respondent, being an experienced pharmacist, should have been aware of the possibility that a permit might be required to import the substances, and, on the evidence, he failed to make any appropriate or reasonable enquiries as to whether any permit would be required, other than a casual enquiry of someone in the context of the importation of substances for cosmetic purposes; 4. although the importation of the substances did not occur, there is evidence that the respondent kept another 2kg of testosterone unlabelled in a refrigerator in the pharmacy which was accessible to his staff; 5. despite the respondent's evidence concerning the reason for the importation of the testosterone, namely to conduct experimentation on the formulation of a means of administration of testosterone, the quantity which he sought to import, namely 7.5kg, was out of proportion to his stated reason for importation; 6. the respondent was pursuing, on the evidence, an aspiration to engage in an activity for the purpose of producing income without having formulated any clear business strategy. As he said in evidence, he was intent on creating some "intellectual property" which he could exploit for profit; 7. the substance was a regulated substance and by reason of that regulation considered to be potentially dangerous to the public; 8. in the respondent's favour, it seems that he did not seek to hide the importation of the substance, despite the fact that it was misdescribed by the Chinese exporter, and there is no suggestion that it was to be used other than for the respondent's own personal use or for the pursuit of his experimentation; 9. the circumstances of the offences include consideration of the storage within the respondent's pharmacy of a regulated substance in a quantity which could not be justified by reference to the conduct of a pharmacy business. 1. We now come to consider whether the circumstances of the offences which we have outlined above render the respondent unfit in the public interest to practise as a pharmacist. In determining this matter we take into account the overriding consideration of the health and safety of the public as mandated by section 3A of the National Law: 3A Objective and guiding principle [NSW] In the exercise of functions under a NSW provision, the protection of the health and safety of the public must be the paramount consideration. 1. We also take into consideration the additional matters which are set out in the extract from HCCC v Do which we have set out above. There is no evidence that the respondent deliberately and knowingly intended to break the law by failing to apply for a permit to import the testosterone. There is evidence that he was naïve and careless in failing to make enquiries about whether he required a permit. Furthermore, there is evidence that the respondent acted inappropriately in endeavouring to import such a large quantity of testosterone which is out of proportion to his stated purpose of conducting experiments. 2. There is also evidence that the respondent conducted himself inappropriately in storing the 2kg of testosterone which he had previously acquired, but we perceive this matter to be outside the circumstances of the offences, which must be confined to the attempted but failed importation of a large quantity of testosterone. 3. We have already commented that we are constrained in considering these proceedings by the manner in which the complaints have been formulated in the Amended Complaint. A consideration of cancellation of registration is confined to the respondent's convictions for the two offences. In that the respondent attempted the importation of the regulated substances through his pharmacy practice, his conduct impacts upon his practice of his profession. Whether this conduct renders the respondent unfit to practise his profession is a matter to be determined by way of an evaluative judgement. Confining ourselves to a consideration of the circumstances of the offences as we have outlined them, we are unable to conclude that by reason solely of those offences the respondent is unfit to practice as a pharmacist so as to justify an order cancelling his registration. As we have said, the offences arose out of the one course of conduct and should be treated as a single event. The failure to obtain a permit was not deliberate, although it was indicative of naïveté and a degree of inappropriate, careless failure to make enquiries. 4. We observe that the respondent has expressed remorse for his conduct and there is evidence that the consequences for him of being subjected to police procedures, including arrest, detention and the criminal court process has had an effect on his health and well-being. We conclude that cancellation or suspension of his registration is not necessary either to reflect concern about his conduct or to deter him from future conduct of the same kind. Nor is it necessary to cancel or suspend the respondent's registration to deter others from engaging in similar conduct. It would be hoped that the protective orders that we intend making will provide sufficient deterrent effect to other pharmacists who might be tempted to engage in conduct of a similar kind. Finally, we do not apprehend that public confidence in the practice of pharmacy will be eroded by reason of the protective orders which we shall make. 5. We repeat that the finding of unsatisfactory professional conduct which we have made is confined to the failures of the respondent to notify the National Board of the charges made against him and the fact of his conviction. These are serious matters, but do not justify cancellation of registration under the National Law. We shall take these matters into account when fashioning appropriate protective orders. 6. We have set out in [45] above an extract from HCCC v Do which establishes the principles to be applied in determining the rationale for the determination of protective orders. We have previously concluded that neither cancellation nor suspension can be justified by reason of the matters contained in Complaint One, and protective orders of this kind are not permitted by reference to the matters contained in Complaint Two. Of the remaining permissible protective orders that may be made, as found in section 149A extracted above, it is appropriate that a reprimand be imposed, and we shall do so. 7. There are a number of other matters which arose during the hearing of these proceedings which are relevant to the protective orders which should be made. 8. During the course of his evidence the respondent said his pharmacy had previously been accredited under the QCPP. We understand that this is a quality assurance program for community pharmacies and provides support and guidance on professional health services and pharmacy business operations. It was developed by the Pharmacy Guild of Australia in 1997, in consultation with the Pharmaceutical Society of Australia and other industry stakeholders. We understand that over 92% of community pharmacies in Australia are QCPP-accredited. 9. The respondent said that he had allowed his accreditation to lapse about five years previously. During the hearing the respondent first said that the accrediting organisation was politically-motivated. He then said that he would not undertake the program because it was not compulsory. He then said that he would seek accreditation because he would need to do so in order to administer vaccines. We note that this failure to seek accreditation persists despite the assurance given by the respondent to the delegates of the Pharmacy Council during the course of the section 150A hearing on 7 May 2019 that he would seek such accreditation. 10. As we have previously observed, the delegates of the Pharmacy Council when conducting the section 150A hearing on 7 May 2019 expressed concerns about the respondent's lack of knowledge concerning his CPD obligations. For the purpose of the hearing of these proceedings the respondent provided details of CPD activities which he had undertaken in 2019 and 2020. We observe that the bulk of those activities occurred during the months of September 2019 and September 2020, just before the end of each annual CPD period. We also observe that the CPD subjects undertaken had little or no relevance to the respondent's professed interest in compounding products. The respondent commented that he was prone to procrastination in terms of completing his CPD requirements, whilst acknowledging that it would be preferable to undertake study regularly throughout the CPD year. 11. We are concerned about the apparent motivation of the respondent in seeking to exploit the compounding of testosterone for explicit financial gain in the absence of any evidence of any formulation of a business plan and of a business structure commensurate with the regulated activities of a manufacturer of pharmaceutical products. Some examples are provided by the nature of the information which the respondent volunteered to the police as referred to in [16] and [17] above. 12. The inappropriate manner in which 2kg of unlabelled white powder were seemingly stored in the respondent's pharmacy as referred to in [20] above is of grave concern in the context of the appropriate operation of a pharmacy. 13. We have made comment on a number of occasions concerning inconsistent evidence and explanations given by the respondent. The matter referred to in [21] is an example. The respondent has impressed us as being a person whose version of events is not always accurate and is sometimes embellished and exaggerated. The material in [24] is a further example. 14. All of these matters are of concern with respect to the respondent's practice as a pharmacist, especially in his role as proprietor. 15. Because we are concerned about aspects of the respondent's behaviour which we have outlined above, it is appropriate, although no order is made that his registration be cancelled or suspended in the circumstances as we have outlined them above, that in the public interest there be continuing restrictions placed on the respondent's entitlement to practice as a pharmacist. The parties have helpfully had discussions between them concerning an appropriate regime to be put in place (albeit that the applicant has always sought cancellation or suspension of registration as a primary position). The protective orders which we intend on making do not reflect in their totality any agreed position of the parties, but in-principle provisions for the appointment of a mentor and practice restrictions, as well as the conduct of an audit are, in our opinion, all necessary measures to be taken in the interests of the health and safety of the public. The imposition of the requirement to undertake a QCPP program merely reflects the respondent's professed intentions over a period of time, and this will ensure that those intentions are fulfilled. In the same vein the restrictions on the respondent's entitlement to compound medications, and to refrain from compounding or storing testosterone products will provide a further layer of public protection. An additional matter 1. There are additional matters which we do not take into account in determining what protective orders should be made in these proceedings, but which upon investigation might arguably impact upon the conduct of medical practitioners, the respondent and his employed staff. 2. When discussing the terms of the restrictions imposed by the conditions on his right to dispense Schedules 4D and 8 drugs, the respondent said in a statement which he had prepared for the purpose of these proceedings that these drugs are commonly dispensed through the pharmacy. He said that on average 50 requests for these drugs were received each day. He did not personally dispense any of them. The respondent produced "a list of my patients that I have put together and the medications that they seek from me". He said that the persons named were patients with whom he had had a long-standing relationship and who came to him for advice, although he did not dispense restricted medication to them. 3. The contents of the list of patients and the medication prescribed to them are of concern to us for reasons which will shortly become clear. Consistent with a non-publication order which we have made, we will not refer to the patients by name, but will do so in a manner which will allow any regulatory authority with an interest in any of the matters disclosed to identify them. The matters of concern are as follows: 1. a total of 500 dexamphetamine 5mg tablets dispensed to a patient on 17 and 31 August and 21 September 2017. The respondent said that he was not concerned with this level of prescription but was aware that the patient was "not entirely compliant". Nevertheless, he did not believe the patient was abusing the medication. He said he probably did not contact the prescriber to discuss the patient's medication; 2. a total of 170 Panadeine Forte tablets dispensed to a patient on 22 and 28 August and 7 and 13 September 2017. The respondent said that this patient had a 10-year history of chronic pain issues. He did not have any cause for concern about the patient, nor did he discuss the dispensing history with the medical practitioner; 3. a total of 150 Valium 5mg tablets dispensed to a patient on 10 and 23 August and 2 September 2017; 4. a total of 200 dexamphetamine 5mg tablets dispensed to a patient on 16 and 30 August 2017; 5. a total of 150 Normison 10mg tablets dispensed on 2, 8, 15, 22 and 28 August and 3 September 2017, self-prescribed by a medical practitioner. The same quantity of the same drug was dispensed on 5, 12, 19, and 26 August and 2 and 9 September 2017 by the same doctor in the name of his wife. In evidence, the respondent said that the prescriber had been taking 5 tablets of this medication per night over a long period. He believed that the prescriber was issuing scripts for himself using his wife's name to avoid detection. In describing the circumstances of this patient, the respondent said "I believe in quality of life"; 6. a total of 200 Ritalin 10mg tablets dispensed to a patient on 18 August and 19 September 2017, together with 25 Normison 10mg on 18 August 2017. The respondent said that this dosage of Ritalin was appropriate, although it was high. The Normison was used to counter insomnia caused by the Ritalin; 7. 300 Valium 5mg tablets dispensed to a patient on 3 and 22 August and 9 and 20 September 2017. The respondent said this was a difficult patient who could be abusive to his staff. He thought that there might be diversion of the medication prescribed to the patient. 1. Following discussion with representatives of the parties during the hearing, we shall arrange for the Tribunal Registry to procure a transcript of the evidence given by the respondent about the matters referred to concerning the medication prescribed to the respondent's patients, which will be forwarded by the Registry to the applicant. We note the applicant's undertaking to forward the transcript, a copy of the annexure M to the respondent's statement and a copy of these reasons for decision to both the Pharmacy Council of New South Wales and the Medical Council of New South Wales. Costs 1. This is a costs jurisdiction. The applicant sought an order for costs in favour which was not opposed. We are not aware of any circumstances which would justify declining to make the costs order sought, and we shall do so. Orders 1. Consequent upon the findings which we have made we make the following orders: 1. The Respondent is reprimanded. 2. The following conditions are imposed on the Respondent's registration: General conditions A. The Respondent must not work as a pharmacist in charge for a period of 24 months or such longer period of time as determined by the Pharmacy Council of New South Wales (the Council). B. The Respondent must not work as the sole pharmacist on duty for a period of 24 months or such longer period of time as determined by the Council. C. The Respondent must not possess, supply, dispense, administer or manufacture any substance detailed in Schedule 8 of the NSW Poisons List (drug of addiction, derivative or compound medication), Schedule 4B (special restricted substance, derivative or compound medication) or Schedule 4D (prescribed restricted substance, derivative or compound medication), or any substance detailed in an equivalent list of any other Australian State or Territory, for a period of 24 months or such longer period of time as determined by the Council. Mentoring conditions D. The Respondent is to undergo mentoring by an experienced pharmacist approved by the Council as follows: i. The Respondent is to nominate to the Council an experienced pharmacist who is unrelated to him, is not a present employee at the Booth Street Pharmacy, Annandale (Pharmacy), and is not a previous employee at the Pharmacy, other than Mr Branko Radojković, to act as his professional mentor (Mentor). ii. The mentoring relationship is to continue for a period of 24 months from the date of the Mentor's appointment, or such longer time as determined by the Council, and at the frequency determined by the Council. iii. The Respondent is to authorise the Mentor to provide reports to the Council at the frequency determined by the Council and to inform the Council within one business day if there is any concern about the Respondent's professional conduct or personal well-being. iv. The Respondent is to authorise the Mentor to report to the Council about his professional conduct and personal well-being at the conclusion of the 24-month period of the mentoring relationship. v. The Respondent is to meet all costs associated with the mentoring conditions. vi. As soon as practicable after the Mentor is appointed by the Council, the Respondent must provide the Mentor with a copy of the decision made by the Tribunal. Auditing conditions E. The Respondent is to: a. apply for Quality Care Pharmacy Program (QCPP) accreditation within 4 weeks of the date of these orders; b. obtain QCPP accreditation for the Pharmacy within 6 months of the date of these orders or such longer period as the Council may allow upon request by the Respondent (such request to be accompanied by submissions as to why the period should be extended); and c. maintain QCPP accreditation for the Pharmacy for a period of at least three years from the date of the accreditation being granted. F. The Respondent is to undergo external auditing as follows: i. The Respondent is to nominate an appropriate external auditor to be approved by the Council (Auditor) for the purpose of conducting regular audits of the Respondent and the Pharmacy as set out below (Audits). ii. The Audits are to focus on (but not be limited to) compliance by the Respondent and the Pharmacy with the Poisons and Therapeutic Goods Act 1966 (NSW), the Poisons and Therapeutic Goods Regulation 2008 (NSW), the Health Practitioner Regulation National Law (NSW) (the National Law), the Health Practitioner Regulation (New South Wales) Regulation 2016 (NSW), and codes or guidelines approved by the Pharmacy Board of Australia pursuant to s 41 of the National Law (the Standards). iii. The Audits are to be conducted in the manner and at the frequency determined by the Council, for a period of at least two years. iv. The Respondent is to authorise the Auditor to provide reports to the Council at the frequency determined by the Council and to inform the Council within 1 business day if there is any concern about the Respondent or the Pharmacy meeting the Standards. v. The Respondent is to meet all costs associated with the auditing conditions. vi. As soon as practicable after the Auditor is appointed by the Council, the Respondent must provide the Auditor with a copy of the decision made by the Tribunal. Compounding conditions G. The Respondent must not allow any aseptic or other form of complex compounding (as defined in clause 4 of the "Guidelines on compounding of medicines" made by the Pharmacy Board of Australia) to take place in any pharmacy in which he has a financial interest, or participate in any such compounding. H. The Respondent must not allow the compounding or manufacturing of any preparation containing testosterone to take place in any pharmacy in which he has a financial interest. I. The Respondent is not to keep, and is to ensure that there are not kept, at the Pharmacy any substances that are not required for the ordinary operation of the Pharmacy. 1. The appropriate review body for the purposes of Part 8, Division 8 of the National Law is the Pharmacy Council of New South Wales. 2. The Respondent is to pay the Applicant's costs, assessed in default of agreement. ********** 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: 08 April 2021