Knowles v Pharmacy Council of NSW

The Council's evidence and submissions

1. The ground stated in the stay application was as follows: That the orders are harsh or oppressive and, on the balance of convenience, ought to be stayed pending a full hearing by the Tribunal.
2. At the hearing, the applicant relied on his affidavit sworn 6 April 2017. This was tendered without objection. He was not required for cross-examination. The applicant states that there were two principal reasons for seeking the stay. The first was the difficulty being suffered by his customers in his inability to fill this prescription for medication. The second was the "oppressive and wide ranging nature" of the conditions that had been placed on his registration.
3. In relation to the first matter, the applicant states that his customers have suffered "severe difficulties" in having their prescriptions field. He explains the nature of his practice is that he fills many scripts issued by medical practitioners that are not readily available in what he describes as a "standard pharmacy". He says that the majority of pharmacies in New South Wales are dispensaries that "simply supply pre-manufactured medications that are generic in their nature". The applicant describes his practice as a "compounding pharmacy whereby the specific ingredients are compounded (or mixed) to achieve the prescribed dosage of the medication (often not available through large pharmaceutical companies)".
4. The applicant attaches to his affidavit letters of complaint from doctors and statements from others including patients of the difficulties they have experienced as a result of the imposition of conditions on his registration.
5. The applicant states that at no time has he dispensed medication that is prohibited by the Therapeutic Goods Administration (TGA), and states that none of the doctors who prescribing the medications have had conditions attached to their registration preventing them from doing so.
6. The applicant states that one of the effects of the conditions is that he is not able to fill prescriptions for a number of items that are not the subject of any enquiry leading to the imposition of conditions by the Council. He attaches a list of prescription items which he submits "fall foul of the conditions that are readily available in any community pharmacy and present no risk to patients when prescriptions are being filled", that he considers he is not able to fill all ordinary interpretations conditions against it. These include substances such as rice protein powder, melatonin, collage and, oxytocin, follistatin and ACE inhibitors (which he states is the most commonly prescribed class of blood pressure medicine in Australia).
7. The applicant notes that that the orders require that he not compound in any pharmacy business in which he has a financial interest. He states that he is a shareholder in a Singaporean public company has a financial interest in a pharmacy in Malaysia which intends to dispense compounded peptides. He has no control over their actions, and is unsure whether he might breach conditions by holding this financial interest.
8. The applicant further notes that the conditions require that he is only allowed to dispense in accordance with the agreed protocol of a registered clinical trial is listed in the Australian New Zealand Clinical Trial Register. He says he has been invited to partake in a global trial situated in China, and that it is unclear to him whether the Council is attempting to prevent him from being involved in dispensing patrols that are not limited to Australia. A further difficulty is that he has been invited to assist the Harvard School of Medicine with the trial, and is unsure whether the condition prevents him from doing so. He submits that all these matters will have a significant impact on his professional and reputation.
9. At the hearing, the applicant's counsel provided and spoke to written submissions dated 2 August 2017. In summary, the applicant's counsel submitted that: 1. The orders of the Council are so vague as to be inconsistent with general permitted practice; 2. The various medications referred to are all medications that are prescribed by practitioners for the treatment of specific medical conditions and that there is no prohibition through the Therapeutic Goods Administration upon the use of any of the items referred to; 3. Additional confusion is evident in relation to the working of the order in that it seeks to restrict clinical involvement; 4. The consequences of the orders are such not only to significantly impede the practice of the applicant in his day to day activities as a pharmacist, but also to restrict medical research and significantly affect members of the community; 5. Significantly, and notwithstanding that the applicant submits that the Council erred on numerous grounds, the applicant is prepared to offer undertakings to address any concerns that may exist prior to the hearing of the appeal. Those undertakings relate to the dispensing of various peptides and the applicant's involvement in clinical trials.
10. In summary, the applicant submits that, in the circumstances, and where no evidence is advanced on the application to support an assertion that there is a risk to the community or that it is in the public interest to maintain the orders of the Council pending an appeal, a stay should be granted, having regard to the principles in Alexander v Cambridge Credit Corp Ltd (1985) 2 NSWLR 658.
11. Further post-hearing submissions were received from the applicant. These submissions addressed additional documents tendered by the Council at the hearing. The applicant concludes his submissions by reminding the Tribunal that the dispensing of the various medications take place only upon a prescription being issued by a doctor; that their dispensing is not prohibited by any regulation; that the medications are available from various sources, and that the medications have not led to any complaint of patient harm or adverse effect.
12. In conclusion, the applicant submits that the mere fact that the findings of the Council were as they were ought not to be given any more weight than being reasons for a decision. It is submitted that the findings do not attract any degree of scientific basis as to the safety or otherwise of any particular substances. It is submitted that the decision to restrict the applicant from supplying particular substances is not based upon detailed or indeed any medical research demonstrating adverse risk.
13. In the circumstances it is submitted that a stay on the conditions imposed should be granted.

The Council's evidence and submissions

1. The Council relies on the affidavit of Ms Patricia Fleming affirmed on July 2017. Ms Fleming is a legal officer employed by the NSW Ministry of Health at the Health Professional Councils Authority. The affidavit provides a background to the application, and annexes the reasons for the June 2017 Decision. In addition, Ms Fleming states that at the hearing of the appeal, the Council anticipates adducing evidence from a specialist endocrinologist about the risks associated with peptides being compounded for human use, and the lack of evidence establishing the safety and efficacy of compounded peptides for human use.
2. Ms Horvath submitted that the Council was concerned about the applicant's practice activities at the time of both Decisions. She submitted that the Council was considered that it was not in the public interest to dispense the peptides while the long-term implications were untested. She emphasised that the applicant was appealing from a decision pursuant to s 150 of the National Law. She submitted that, pursuant to s 150, if at any time the Council is satisfied it is appropriate to do so for the protection of the health or safety of any person or persons, or if satisfied the action is otherwise in the public interest, the Council must suspend a registered health practitioner's registration (s 150(1)(a)) or impose conditions on their registration (s 150(1)(b)).
3. Ms Horvath also submitted that the granting of the stay would undermine the effectiveness of the Decisions. She submitted that the applicant had advanced two reasons for lifting the stay. The first was because of the "severe difficulties' for his customers. Ms Horvath said that this overlooked the ultimate question that the Tribunal would eventually have to determine, whether the dispensing of the compounds was safe and efficacious. She referred to the Decisions, and noted the Council's concerns about the thousands of scripts being dispensed by the applicant where the long-term safety and efficacy of the compounds was not clear and where this was done in breach of the applicant's obligations to dispense medications for a clinical reason.
4. The second reason identified by the applicant was that the conditions were oppressive and wide ranging. She submitted that it was difficult to understand the applicant's concerns, particularly in respect of any involvement in a clinical trial conducted by Harvard University.
5. Finally, Ms Horvath submitted that it would be inconsistent with s 3A of the National Law to impose a stay. Section 3A, which sets out the objective and guiding principle of the National Law for NSW, provides that, the protection of the health and safety of the public must be the paramount consideration.

Principles to be applied

1. As was noted in Kesserwani v Chiropractic Council of NSW [2015] NSWCATOD 77 at [9], the NCAT Act does not specify the factors to be taken into account in determining whether the discretionary power to stay the operation of a decision under appeal should be exercised.
2. In Bentran Pty Ltd v Sabbarton [2014] NSWCATAP 37, after examining the authorities, the President of Tribunal (Wright J) summarised the principles to be applied in determining whether or not to grant a stay pending the determination of the appeal (see par [9]). In summary, those principles included the following: 1. The onus is on an applicant for a stay to make out a case that it is appropriate for the court or Tribunal to make such an order. 2. An order staying the operation of a decision or orders will generally be appropriate where such an order is reasonably necessary to secure the effectiveness of the appeal. This is similar to, if not the same as, the considerations applied by the Courts where there is a risk that an appeal will prove abortive if the appellant succeeds and a stay is not granted or where unless a stay is granted an appeal will be rendered nugatory, the discretion should generally be exercised in favour of granting a stay. 3. The Tribunal may also take into account the strength or otherwise of the case of the party seeking the stay. This consideration may be particularly relevant when it is plain that an appeal, which does not require leave, has been lodged without any real prospects of success and simply in the hope of gaining a respite against immediate execution of the decision. 4. The Tribunal's power to grant a stay includes a power to make such an order subject to such conditions as the Tribunal specifies. 5. In exercising the discretion, the Tribunal will weigh the balance of convenience and the competing rights of the parties and may impose appropriate conditions so as to achieve a result that is fair to all parties. 6. Finally, the overriding principle in an application for a stay is to ask what the interests of justice require.
3. Bentran was a decision concerning a claim in the Consumer and Commercial Division of the Tribunal. The appeal the subject of the present stay application is brought in the Occupational Division of the Tribunal. In considering a health practitioner's application for a stay, the Tribunal must consider the protection of the health and safety of the public, which is the paramount consideration of the Tribunal: Kesserwani v Chiropractic Council of NSW [2016] NSWCATOD 77 at [16]; Wang v Dental Council of NSW [2016] NSWCATOD 90 at [22]. In addition, the protection of the public is a matter entitled to significant weight on an application for a stay once it appears that a professional person has acted improperly to a substantial degree: NSW Bar Association v Stevens [2003] NSWCA 95.

Consideration

1. The applicant advanced three principal reasons why a stay should be granted.
2. The first reason is said to be the difficulty being suffered by his patients in his inability to fill this prescription for medication. I will assume that this is the case. But, this evidence must be taken into account within the context against which the stay application is being considered. That is, the conditions were put in place for the protection of the public and in the public interest. The greater the justification for the making of the prohibition order, the less consideration should be given to the significance of the impact upon in the circumstances of this application, the applicant, and his patients: Kaye v Health Care Complaints Commission [2016] NSWCATOD 268 at [36]; Hanna v Medical Council of NSW [2016] NSWCATOD 108 at par [60] and following.
3. I do not accept that this ground warrants the imposition of a stay.
4. The second reason was the "oppressive and wide ranging nature" of the conditions that had been placed on his registration. I do not accept that this is the case and share the Council's difficulties in understanding why this is the case. I do not accept that this ground warrants the imposition of a stay.
5. The third reason that the mere fact that the findings of the Council were as they were ought not to be given any more weight than being reasons for a decision. It was submitted that the findings do not attract any degree of scientific basis as to the safety or otherwise of any particular substances. It is submitted that the decision to restrict the applicant from supplying particular substances was not based upon detailed or indeed any medical research demonstrating adverse risk. I reject this submission, as it appears to overlook the nature and function of the Council (and the constitution of the Council itself) in conducting s 150 (and s 150A) proceedings. As has been observed before (see the discussion in Burton v Osteopathy Council of New South Wales [2015] NSWCATOD 150 at [23] to [26]) the s 150 decision making process may necessarily not involve the Council or its delegates in a detailed examination of factual matters the subject of a complaint, and the material relied upon the purpose of determining whether action should be taken may include material that would not conventionally be considered as strictly evidentiary in nature. What s 150 envisages is action on an urgent basis because of the need to protect public health and safety.
6. I do not accept that this ground warrants the imposition of a stay.
7. In my view, none of the reasons relied on by the applicant individually, or collectively, warrant an imposition of a stay of the Decisions. There are a number of other matters which confirm this conclusion.
8. First, I note that no submissions were made by the applicant as to the strength of the applicant's case on appeal. This was a matter commented on by the respondent.
9. Secondly, the Council had before it, and referred to it expressly in its reasons for the January 2017 Decision, a complaint of the Pharmaceutical Regulatory Unit dated 7 October 2016. That document stated that the applicant had dispensed almost 8,000 prescriptions for peptides, proteins and selective androgen receptor modulators in under two years, in circumstances where it was unclear what recognised science-based evidence supported the applicant's professional judgement to compound and dispense those items in accordance with recognised therapeutic standards. Accordingly, I reject the applicant's submission that there was no evidence to support an assertion that there is a risk to the community.
10. Thirdly, the PBA Guidelines requires a pharmacist to ensure that the medicine is "clinically appropriate for the patient". As noted in par [49] of the reasons for the January 2017 Decision, the applicant admitted to the Council that he did not always know the indication for use. As such, the Council found that the applicant was dispensing in breach of the PBA Guidelines.
11. Fourthly, if a stay were granted, the conditions put in place to protect the public would be (to use the terms of Ms Horvath's oral submission), "swept away for an indeterminate length of time", in circumstances where there is no evidence that the applicant had taken steps to obtain evidence for or expedite the appeal.
12. Fifthly, I accept the Council's submission that it is not in the public interest to stay the operation of the conditions in circumstances where there is a lack of evidence about the safety and efficacy of the various substances being dispensed.
13. I do not accept that the undertakings offered by the applicant adequately protect of the health and safety of the public.

Conclusion

1. I have carefully considered the matters advanced by the applicant, and the principles set out in Bentran. In its January 2017 Decision, given the applicant's lack of adherence to the PBA Guidelines and the lack of substantive evidence provided for the safety and efficacy of the peptides in humans, the Council concluded that the applicant's practise in relation to the dispensing of peptides was not within accepted standards nor complaint with PBA Guidelines. In addition, the Council found that the applicants' practice of dispensing of peptides did not meet the public interest in terms of satisfying the values and qualities set out in the PBA Code of Conduct for Pharmacists. The Council considered that the particular risks posed by the appcalint's practice and his failure to meet the public interest should be minimised by the imposition of conditions on his registration.
2. In my view, the protection of the health and safety of the public must be the paramount consideration. In my view, the interests of justice require that the conditions remain in place and that the applicant's request for a stay of the Decisions be refused.
3. The costs of the application are reserved.

Orders The Tribunal orders that: 1. The application for the stay of the Decisions of the Council is refused. 2. Costs 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: 25 September 2017