//
© 2026 Zoe. All rights reserved.
Zoe is a legal information platform. Always consult the Federal Register of Legislation for authoritative text.
[2025] NSWCA 105
appellant. Leave to appeal in relation to ground 7 was granted; the appeal was allowed; the Tribunal’s orders made on 24 October 2024 were set aside; the matter was remitted to a differently constituted...
The Court of Appeal majority overturned the Tribunal’s finding of professional misconduct. It concluded that the doctor had not been given fair notice of the specific claim that financial pressure to sell Somatropin stock compromised her clinical objectivity. It also held that the Tribunal had not rationally explained why it rejected her oral account of patient consultations. Finally, the Tribunal’s statements that no IGF-1 tests had been sought and that all monitoring was missing conflicted with the patient records. The complaint must be reconsidered by a differently constituted Tribunal. Adamson JA dissented, taking a different view of the notice, evidence and factual findings.
AI-generated legal information, not legal advice. Zoe can make mistakes. Check the cited source, and for advice about your situation consult a qualified Australian lawyer.
2,500 words · generated 06/10/2026
Dr Albina Della Bruna prescribed and directly dispensed Somatropin, a human growth hormone, to ten patients between June 2017 and November 2019. The prescriptions were off-label and were said to relate to fatigue, ageing and wellness concerns. The Health Care Complaints Commission alleged inappropriate prescribing and dispensing, inadequate management and record-keeping, and professional misconduct. The appellant admitted the record-keeping complaint, though not every particular of it ([1], [24]–[30], [44]).
14 cited instruments linked from this judgment.
The Tribunal’s majority comprised two medical senior members and a general member. It found the complaints established and found professional misconduct. The presiding principal member, Coleman SC ADCJ, dissented on the first complaint and considered that only the admitted record-keeping complaint was made out. The professional misconduct finding was consequential on the majority’s view of the conduct as a whole ([1], [109]–[111], [201]–[202]).
The Court of Appeal majority, Bell CJ and Kirk JA, allowed the appeal on three issues. First, the appellant had not been fairly notified of the specific theory that the financial pressure of holding and turning over Somatropin stock compromised her objectivity. Second, the Tribunal did not adequately explain why it rejected the appellant’s oral evidence about her consultations and management of patients. Third, its findings about the absence of IGF-1 testing and other monitoring contradicted contemporaneous clinical records ([3]–[4], [43], [63], [68]–[83]).
The Court also noted that the Tribunal had not identified and applied the statutory definition of professional misconduct in s 139E. No appeal ground specifically challenged that point, but the Court considered the statutory test important enough to address ([5]–[7]). Adamson JA dissented from the appeal outcome. Her Honour considered the financial case sufficiently notified and considered the Tribunal’s treatment of testing and monitoring sustainable when read in context ([224]–[229], [293]–[300]).
The first ground concerned procedural fairness. The Commission’s Amended Complaint alleged inappropriate dispensing, but did not expressly plead that the appellant’s clinical objectivity was compromised by a financial incentive or pressure to turn over stock. When the appellant requested particulars of “inappropriate dispensing”, the Commission answered that the medication was dispensed directly to patients, particularly where it was prescribed off-label without a clinical, scientific or medical basis. That answer did not state the stock-turnover theory ([24]–[30]).
The Commission pointed to two expert reports. Bell CJ and Kirk JA considered that the relevant language did not give clear notice of the case ultimately found by the Tribunal. Dr Kertesz referred to “the attraction of a fee for the medication delivered to the patient”, which naturally conveyed that the doctor profited from a fee for dispensing. In fact, she dispensed the medication at cost. Professor Carter had referred to “possible financial considerations”, but that wording was struck out before the final hearing as gratuitous and speculative. The Court regarded the remaining suggestion as vague, not a clear allegation that stock costs created pressure which impaired clinical judgment ([31]–[39]).
The Tribunal’s reasoning moved from the appellant’s monthly stock purchases to a conclusion that holding the inventory would give her reason to create turnover and influence her objectivity. The Court considered that inference speculative on the case as pleaded and put. It had not been squarely put to the appellant in cross-examination, and she had not been asked to explain whether she felt pressure to sell stock or whether that affected prescribing decisions. The opportunity to make closing submissions did not substitute for a chance to give evidence in response to a serious allegation ([21]–[23], [36]–[43]). The Court therefore treated the breach as material, not merely technical.
The second issue was the rejection of oral evidence. The Tribunal majority reasoned that the patient records should contain information about consultations and that oral evidence given three or four years later could not replace contemporaneous records. It then stated that if an action, justification or monitoring step was not in the record, it did not occur ([45]–[47]).
The Court accepted that the appellant’s records were inadequate. But an obligation to keep good records does not itself show that a later recollection is unreliable. Nor does the general proposition that contemporaneous notes are often useful establish that oral evidence has no value, particularly when it expands on what a record does contain. A Tribunal may reject evidence, but should identify a rational basis, such as inconsistencies, contradictions, demonstrated failures of recollection, or other evidence undermining it. The Majority did not do so ([52]–[60]).
The Court also considered that the failure to engage with the appellant’s account affected a substantial part of the case. The appellant had given extensive evidence about patient consultations and management. The Tribunal’s global approach did not explain why that evidence was rejected, and it treated absence from the notes as proof of absence. The Court characterised the error as inadequate reasons and, in substance, a failure to grapple with a substantial aspect of the appellant’s case ([60]–[63]).
The third issue concerned factual findings about testing and monitoring. The Majority said that the appellant had not sought IGF-1 blood tests for any of the ten patients and that all the monitoring identified by an expert was missing from the records ([65]–[66]). But the Court identified clinical-record entries showing IGF-1 tests and results for each of patients A to J, as well as entries for blood pressure, height, weight, lipids and glucose in various patients’ records ([71]–[80]). Those records were not perfect, and the appellant admitted shortcomings. The problem was that the Tribunal’s findings described monitoring as absent, not merely inadequate.
The errors mattered because the Tribunal linked the supposed absence of monitoring to serious negligence, patient safety and the seriousness of the conduct ([75]–[83]). The Court rejected the dissent’s reading that the Majority had only found that no tests were performed for the purpose of identifying excess growth hormone before prescribing. It considered that the Majority’s unqualified statement that no tests had been sought, and its statement that “all” monitoring was missing, could not fairly be read that way ([84]–[98]).
The judgment’s central legal statements concern statutory construction, procedural fairness, reasons and fact-finding in health practitioner discipline.
On professional misconduct, the Court stated that s 139E of the Health Practitioner Regulation National Law (NSW) defines the concept as unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of registration, either as a single instance or through the cumulative effect of multiple instances. It warned against relying on older authorities applying differently expressed statutory tests. The Tribunal’s reliance on Pillai v Messiter (No 2) was therefore misplaced in this setting ([5]–[7]). This was a statement about the governing statutory test, even though no appeal ground directly raised it.
On reasons, the judgment recognises that specialist tribunal members need not write like judges. Their reasons should be read fairly and as a whole, with allowance for compressed reasoning or infelicities of language. But this does not permit a reviewing court to invent reasons or fill gaps by speculation. Reasons must be sufficient to let a court determine whether legal error has occurred. The Court cited Ghosh, Wingfoot, Orr and Gautam in articulating that approach ([9]–[16]).
On procedural fairness, the case applies the familiar requirement that a person affected by a decision be fairly apprised of the case against them and have a reasonable opportunity to answer it. The allegation must be clear enough that the person is not left to guess at the case or “box at vague shadows” ([42]). Here, expert-report references and later closing submissions did not cure the failure to state the particular adverse theory clearly in the complaint or particulars, nor did they give the appellant a proper opportunity to answer it in evidence ([24]–[43]).
On factual error, the judgment illustrates the importance of reading findings against the contemporaneous material that was before the decision-maker. It does not establish that every factual mistake permits an appeal. Rather, the Court granted leave under the applicable tribunal appeal regime because the errors were serious and material to the decision ([64]–[68], [75]–[83]). The judgment does not alter the underlying requirement that clinical records be adequate. The appellant admitted that they were not. It does, however, reject the proposition that deficient records alone permit a decision-maker to treat every unrecorded event as something that never happened ([57]–[59]).
The case does not decide whether the prescribing and monitoring were clinically adequate, whether professional misconduct was ultimately established, or what discipline would be appropriate. Those matters remained for the Tribunal on remittal ([99]–[101]).
At [16], the Court says review should not be conducted with an “eye keenly attuned” to finding error, but the reviewing court need not force an interpretation that avoids error. In plain English, reasons are read sensibly and in context, but ambiguity does not automatically save a decision if the reasoning actually stated is defective.
At [42], the Court says a person should not be left “to guess, nor required to box at vague shadows.” In plain English, a regulator must state the substance of a serious allegation clearly enough for the practitioner to know what evidence or explanation is needed.
At [57], the Court calls it a non sequitur to infer that because records are generally better evidence, later explanations are worthless. In plain English, poor records may weaken a practitioner’s position, but do not automatically prove that an event did not occur or that recollection is unreliable.
At [63], the Court identifies the Tribunal’s failure to give adequate, intelligible or logical reasons and its failure to grapple with a substantial aspect of the case. In plain English, a tribunal cannot dispose of relevant evidence through a blanket assertion; it must explain the reasoning that connects the evidence to its findings.
At [83], the Court says the records were imperfect but sufficiently detailed to contradict the conclusion that IGF-1 tests had not even been sought and that all monitoring was absent. In plain English, the issue was not whether the records were ideal, but that the Tribunal’s description of them was factually wrong in a material way.
The procedural fairness reasoning is relevant where a regulator’s pleaded case alleges one kind of conduct, but a tribunal makes a serious adverse finding based on a different or more specific theory that was not clearly notified. In Della Bruna, the pleaded allegation concerned inappropriate direct dispensing and off-label prescribing; the material finding concerned pressure to turn over stock and compromised objectivity. The Court stressed the gap between the broad allegation and the specific conclusion ([24]–[43]).
The reasons analysis is relevant where a tribunal rejects substantial oral evidence through a general rule, for example, that evidence given years later is unreliable or that anything not recorded did not happen, without explaining why that evidence is unreliable in the case at hand ([45]–[63]). The decision does not prevent a tribunal from preferring contemporaneous records or rejecting recollection. It indicates that the reasoning should be articulated and rationally connected to the evidence.
The factual-error analysis is relevant where a tribunal makes a categorical finding about what records contain or what tests occurred, and the records themselves materially contradict that finding. The Court relied on identified examples across all ten patients and treated the errors as important because the Tribunal’s assessment of negligence and risk depended on an absence of monitoring ([71]–[83]).
The judgment should not be read as determining the clinical standard for off-label growth hormone prescribing. The Court’s focus was the legal integrity of the decision-making process and the correctness of material factual premises. It did not substitute its own assessment of the appellant’s clinical conduct or decide the complaint on its merits.
The supplied judgment provides no information about later judicial treatment of Della Bruna v Health Care Complaints Commission itself. It was decided on 16 May 2025, and the text does not identify any later cases applying, distinguishing or criticising it. Accordingly, no claim about subsequent treatment can be made from this source.
The judgment does discuss the authorities it applies or refers to. Chen is relied on for the warning against applying professional misconduct tests from differently worded statutory schemes ([7]). Ghosh, Wingfoot, Orr and Gautam inform the requirement for legally adequate reasons ([11]). Johnson, Kanda and Alphaone are cited for procedural fairness and notice of the case to be met ([42]). Waterways Authority v Fitzgibbon and D’Amore support the principle that reasons actually stated are treated as the steps taken, rather than supplemented by assumed unspoken reasoning ([54]).
The dissent’s reasoning is not the Court’s holding. Adamson JA considered that the particulars and evidence sufficiently raised financial considerations, that the appellant had an opportunity to respond in re-examination, and that the Majority’s findings on testing were qualified by purpose and timing ([224]–[229], [293]–[300]). The majority rejected those readings. That division of opinion should be kept in view when describing the case, particularly on the scope of notice and the factual findings about monitoring.
The main question left open is the ultimate disposition of the Commission’s Amended Complaint. The Court set aside the Tribunal’s orders and remitted the matter, leaving the complaint undetermined ([99]–[103]). The differently constituted Tribunal must reconsider the evidence and the allegations; the Court did not determine whether the conduct amounted to unsatisfactory professional conduct or professional misconduct.
The appropriate weight to give the appellant’s records and oral evidence also remains open. The Court held that the Majority’s blanket reasoning was inadequate, not that the appellant’s recollections had to be accepted. A properly constituted Tribunal may assess credibility and reliability by reference to the evidence, but the reasons would need to identify a rational basis for its conclusions ([52]–[63]).
The adequacy of the appellant’s actual monitoring remains unresolved. The records established that some testing and observations occurred, but the Court did not determine whether their timing, scope or clinical use met the applicable standard. It expressly noted that there had been no analysis of the adequacy of monitoring actually undertaken, which would be necessary to assess whether the conduct fell significantly below the expected standard ([97]–[98]).
The judgment also does not determine the full content of the appropriate clinical standard for off-label prescribing in the circumstances. The experts’ evidence and the Tribunal’s reasons addressed monitoring, risks, assessment and patient management, but the Court’s appeal decision did not resolve conflicts in that evidence or make a final clinical assessment.
Finally, the Court’s observations about s 139E identify the statutory test the Tribunal must apply, but the judgment does not decide whether the appellant’s conduct, if established on reconsideration, meets that threshold. The distinction between conduct significantly below the expected standard under s 139B and professional misconduct sufficiently serious to justify suspension or cancellation under s 139E remains a separate evaluative question ([5]–[7]).
This is general legal information, not legal advice. Zoe can make mistakes. Before acting on this, relying on it, or using any draft, have a qualified Australian lawyer check it.
Source: NSW Caselaw (www.caselaw.nsw.gov.au). Converted to plain text by ZoeLaw. Not the official version.
Medium Neutral Citation: Della Bruna v Health Care Complaints Commission [2025] NSWCA 105
Hearing dates: 10 April 2025
Date of orders: 16 May 2025
Decision date: 16 May 2025
Before: Bell CJ and Kirk JA at [1];
Adamson JA at [104]
Decision: (1) Grant leave to appeal in relation to ground 7.
(2) Appeal allowed.
(3) The orders of the Tribunal made on 24 October 2024 are set aside.
(4) The matter is remitted to the Tribunal, to be differently constituted.
(5) The respondent is to pay the appellant’s costs of the appeal.
Catchwords: OCCUPATIONS – Health practitioners – Professional misconduct – Where appellant prescribed somatropin off-label – Where clinical records inadequate – Requirement for NSW Civil and Administrative Tribunal to provide adequate reasons – Requirement to afford procedural fairness by notifying appellant of allegations through amended complaint – Where findings of fact contradicted by contemporaneous clinical records
Legislation Cited: Civil and Administrative Tribunal Act 2013 (NSW),
ss 38, 57, Sch 5 Pt 6 cll 12-13, 29
Evidence Act 1995 (NSW), s 140
Health Practitioner Regulation (Adoption of National Law) Act 2009 (NSW), Sch 1 [1A], [5A]
Poisons and Therapeutic Goods Act 1966 (NSW), s 8
Supreme Court Act 1970 (NSW), s 48
Health Practitioner Regulation (New South Wales) Regulation 2016 (NSW)
Health Practitioner Regulation National Law (NSW) 2009, ss 3A, 3B, 139B, 139C, 139E, 140, 144B, 145C, 145D, 150, 165, 165B, 165M, Pt 8 Div 2, Pt 8 Div 3
Cases Cited: Allianz Australia Insurance Ltd v Rutland [2015] NSWCA 328; (2015) 73 MVR 211
Bisley Investment Corporation Ltd v Australian Broadcasting Tribunal (1982) 59 FLR 132
Briginshaw v Briginshaw (1938) 60 CLR 336; [1938] HCA 34
Chamberlain v The Queen (No 2) (1984) 153 CLR 521; [1984] HCA 7
Chen v Health Care Complaints Commission (2017) 95 NSWLR 334; [2017] NSWCA 186
Collector of Customs v Pozzolanic Enterprises Pty Ltd (1993) 43 FCR 280
Commissioner for ACT Revenue v Alphaone (1994) 49 FCR 576
Communications, Electrical, Electronic, Energy, Information, Postal, Plumbing and Allied Services Union v Abigroup Contractors Pty Ltd [2013] FCAFC 148
D’Amore v Independent Commission Against Corruption [2013] NSWCA 187; (2013) 303 ALR 242
De Gruchy v The Queen (2002) 211 CLR 85; [2002] HCA 33
Dranichnikov v Minister for Immigration and Multicultural Affairs [2003] HCA 26; (2003) 77 ALJR 1088
Gautam v Health Care Complaints Commission [2021] NSWCA 85
Ghosh v Health Care Complaints Commission (2020) 104 NSWLR 107; [2020] NSWCA 353
Johnson v Miller (1937) 59 CLR 467; [1937] HCA 77
Jones v Sutherland Shire Council [1979] 2 NSWLR 206
Kanda v Government of Malaya [1962] AC 322
Kavieris v Health Care Complaints Commission [2025] NSWSC 20
Kumar v Legal Services Commissioner [2015] NSWCA 161
Laws v Australian Broadcasting Tribunal (1990) 170 CLR 70; [1990] HCA 31
LPDT v Minister for Immigration, Citizenship, Migrant Services and Multicultural Affairs [2024] HCA 12; (2024) 98 ALJR 610
McAuliffe v Secretary, Department of Social Security (1992) 28 ALD 609
Minister for Home Affairs v Ogawa (2019) 269 FCR 536; [2019] FCAFC 98
Minister for Immigration and Ethnic Affairs v Wu Shan Liang (1996) 185 CLR 259; [1996] HCA 6
New South Wales Land and Housing Corporation v Orr (2019) 100 NSWLR 578; [2019] NSWCA 231
Onassis v Vergottis [1968] 2 Lloyd’s Rep 403
Pillai v Messiter (No 2) (1989) 16 NSWLR 197
Plomp v The Queen (1963) 110 CLR 234; [1963] HCA 44
Politis v Commissioner of Taxation (Cth) (1988) 16 ALD 707
Rich v Australian Securities and Investments Commission (2004) 220 CLR 129; [2004] HCA 42
Seablest Pty Ltd v Smith (1996) 91 LGERA 1
SZCBT v Minister for Immigration and Multicultural Affairs [2007] FCA 9
The Queen v Baden-Clay (2016) 258 CLR 308; [2016] HCA 35
Waterways Authority v Fitzgibbon [2005] HCA 57; (2005) 79 ALJR 1816
Watson v Foxman (1995) 49 NSWLR 315
Weaver v The Law Society of NSW (1979) 142 CLR 201; [1979] HCA 35
Willmot v Queensland [2024] HCA 42; (2024) 98 ALJR 1407
Wingfoot Australia Partners Pty Ltd v Kocak (2013) 252 CLR 480; [2013] HCA 43
Texts Cited: N/A
Category: Principal judgment
Parties: Dr Albina Della Bruna (Appellant)
Health Care Complaints Commission (Respondent)
Representation: Counsel:
R Mathur SC / Z Alderton (Appellant)
Z Heger SC / D New / C Beshara (Respondent)
Solicitors:
Avant Law Pty Ltd (Appellant)
Health Care Complaints Commission (Respondent)
File Number(s): 2024/428418
Publication restriction: N/A
[This headnote is not to be read as part of the judgment]
These proceedings arose from a complaint filed by the Health Care Complaints Commission (the Commission) against Dr Albina Della Bruna (the appellant) in the NSW Civil and Administrative Tribunal. The disciplinary proceedings concerned the appellant’s off-label prescribing of human growth hormone (HGH) to patients. The Commission complained that the appellant inappropriately prescribed, dispensed and managed the HGH, and failed to maintain adequate records. The appellant accepted before the tribunal that she had failed to maintain adequate records.
The majority of the tribunal (Dr Badam, Dr Newberry, and Ms Lovrovich) found the appellant guilty of professional misconduct, while the presiding member (Coleman SC ADCJ) dissented, making a finding of unsatisfactory professional conduct only.
The appellant challenged the majority’s decision on various bases, including that it: (i) denied the appellant procedural fairness in finding that her objectivity was compromised by financial pressure; (ii) erred in rejecting the appellant’s oral evidence; and (iii) erred in various factual findings in relation to the extent of testing and monitoring performed by the appellant.
The Court (Bell CJ and Kirk JA, Adamson JA dissenting), allowing the appeal, held:
(1) “Professional misconduct” under s 139E of the Health Practitioner Regulation National Law (NSW) 2009 means unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner’s registration: [5]-[7] (Bell CJ and Kirk JA).
Chen v Health Care Complaints Commission (2017) 95 NSWLR 334; [2017] NSWCA 186, referred to.
Pillai v Messiter (No 2) (1989) 16 NSWLR 197, not applicable.
(2) Medical and lay members of tribunals must give legally adequate reasons, which are sufficient to enable a court to see whether the opinion involves any error of law. Where the nature of the issues and the potential consequences are serious, there may be little difference in substance from the duty of a court to give reasons. The Court’s review of the reasons of a decision-maker should not proceed in a manner inclined to finding error. But that does not mean the Court must strive to read the reasons in such a way as to avoid the conclusion of error. The Court should not be left to speculate about what further unarticulated reasons lie behind what tribunal members said: [9]-[16], [41], [54] (Bell CJ and Kirk JA).
Seablest Pty Ltd v Smith (1996) 91 LGERA 1; Ghosh v Health Care Complaints Commission (2020) 104 NSWLR 107; [2020] NSWCA 353; Wingfoot Australia Partners Pty Ltd v Kocak (2013) 252 CLR 480; [2013] HCA 43; New South Wales Land and Housing Corporation v Orr (2019) 100 NSWLR 578; [2019] NSWCA 231; Gautam v Health Care Complaints Commission [2021] NSWCA 85; Waterways Authority v Fitzgibbon [2005] HCA 57; (2005) 79 ALJR 1816; D’Amore v Independent Commission Against Corruption [2013] NSWCA 187; (2013) 303 ALR 242, cited.
(3) The majority erred, and breached the requirements of procedural fairness in a material manner, by finding that the appellant’s objectivity was inhibited by a financial pressure to dispose of her HGH stockpile. This was not alleged as part of the Commission’s case where it should have been, being the Amended Complaint, nor was it stated in terms in a letter providing further particulars. The references in the Commission’s letter to parts of two reports at best made some vague and speculative wave towards there being some financial motivation of an unstated kind: [17]-[43] (Bell CJ and Kirk JA).
Johnson v Miller (1937) 59 CLR 467; [1937] HCA 77; Kanda v Government of Malaya [1962] AC 322; Commissioner for ACT Revenue v Alphaone (1994) 49 FCR 576; LPDT v Minister for Immigration, Citizenship, Migrant Services and Multicultural Affairs [2024] HCA 12; (2024) 98 ALJR 610, referred to.
(4) The majority erred by failing to provide adequate, intelligible or logical reasons for why the appellant’s oral evidence was rejected, and also failed to exercise jurisdiction insofar as it did not grapple with a substantial and clearly articulated aspect of the appellant’s case. The fact that the appellant conceded that her record-keeping was substandard did not, in itself, provide a rational reason to reject her evidence as to the nature and context of her consultations: [44]-[63] (Bell CJ and Kirk JA).
(5) The majority erred in material findings of fact which were contrary to the contemporaneous clinical records: [64]-[98] (Bell CJ and Kirk JA).
Per Adamson JA dissenting:
(6) The Tribunal did not err, nor breach procedural fairness, in finding that the appellant’s “objectivity” was compromised as a result of financial “pressure” to turnover her stock of Somatropin. The Commission’s case was sufficiently particularised to raise financial considerations as a motive which affected the appellant’s practice of dispensing Somatropin. Furthermore, the appellant had additional notice that the Commission placed reliance on financial considerations when it was raised in cross-examination. Consequently, the appellant was provided with a forensic opportunity in re-examination to respond to the allegations: [216]-[229] (Adamson JA).
De Gruchy v The Queen (2002) 211 CLR 85; [2002] HCA 33; Plomp v The Queen (1963) 110 CLR 234; [1963] HCA 44; Chamberlain v The Queen (No 2) (1984) 153 CLR 521; [1984] HCA 7; The Queen v Baden-Clay (2016) 258 CLR 308; [2016] HCA 35; Jones v Sutherland Shire Council [1979] 2 NSWLR 206, cited.
(7) The Tribunal did not err, nor was it legally unreasonable, in rejecting Associate Professor Holmes-Walker’s assessment that the appellant’s conduct fell below, but not significantly below, the relevant standard. The Tribunal’s reasons adequately explained its preference for Dr Kertesz’s and Professor’s Carter’s opinion evidence, which it was entitled to do: [276]-[278] (Adamson JA).
(8) The Tribunal did not err in failing to consider a substantial and clearly articulated argument: namely whether the prescribing and dispensing of certain medication, in the quantities prescribed, was significantly below the expected standard. The Tribunal provided detailed reasoning based on the expert evidence, and it was plain from the structure and content of the Tribunal’s reasons that it had regard to all of the Principal Member’s reasons: [279]-[281] (Adamson JA).
Dranichnikov v Minister for Immigration and Multicultural Affairs [2003] HCA 26; (2003) 77 ALJR 1088, cited.
(9) The Tribunal did not err in fact in finding that: (i) the appellant did not seek blood tests to measure the IGF-1 levels in any patients to whom she prescribed human growth hormones; and (ii) that evidence of ‘ongoing monitoring’ was ‘missing’ from the appellant’s patient records. The Tribunal was careful in its reasons to qualify its finding that the appellant failed to order tests by purpose (to determine whether there was growth hormone deficiency) and by time (before she prescribed any Somatropin): [291]-[300] (Adamson JA).
BELL CJ and KIRK JA: The appellant, Dr Albina Della Bruna (the appellant), prescribed and dispensed human growth hormone (HGH) to ten patients in the period June 2017 to November 2019, doing so “off-label” for reasons said to be connected to fatigue and ageing. The Health Care Complaints Commission (the Commission) brought a complaint in the Occupational Division of the NSW Civil and Administrative Tribunal alleging that this conduct, together with inadequate record keeping, constituted unsatisfactory professional conduct and professional misconduct for the purposes of the Health Practitioner Regulation National Law (NSW) 2009 (the Law). A majority of the Tribunal, writing jointly, concluded that the appellant had engaged in such professional misconduct. The majority was comprised of the two senior members of the Tribunal, who are doctors, along with a general member (the Majority). The presiding principal member of the Tribunal, Ian Coleman SC ADCJ, dissented, and would have found the appellant guilty of unsatisfactory professional conduct only. The remedial “stage 2” hearing is yet to take place.
The appellant has appealed. She has a right to do so on questions of law and may seek leave to do so on any other grounds: Civil and Administrative Tribunal Act 2013 (NSW) (CAT Act), Sch 5, cl 29(4)(b).
Her amended notice of appeal raised many grounds, but as oral argument was developed particular attention was directed to the following issues:
whether the Majority denied the appellant procedural fairness in finding that her objectivity was compromised as a result of financial pressure to turn over her stock of HGH (ground 5(a));
whether the Majority erred in rejecting the appellant’s oral evidence regarding her prescribing to and management of patients, and thereby reversed the onus of proof, constructively failed to exercise jurisdiction, denied procedural fairness and gave inadequate reasons (grounds 2, 4, 5(b) and 6, noting those grounds also raised other issues);
whether the Majority erred in fact in finding that the appellant did not seek blood tests to measure the IGF-1 levels in any patients to whom she prescribed HGH (ground 7, noting leave to appeal is required for this ground).
Success on any one of these issues would be sufficient to uphold the appeal. In our view the appellant should succeed on all three. It is unnecessary to address the remainder of the issues and grounds raised. The matter should be remitted to a differently constituted Tribunal.
One further significant point should also be noted at the outset. Although many grounds of appeal were raised, there was no ground relating to how both the Majority and the presiding member of the Tribunal directed themselves as to the meaning of professional misconduct. Given the importance of the topic, the Tribunal’s approach should not be left unremarked. The Majority (at [356]) followed the presiding member (at [263]) in considering that this issue turned on a standard articulated by Kirby P in (1989) 16 NSWLR 197 at 200. Yet Kirby P’s discussion related to a past statutory scheme involving a different criterion. Under the Law the notion of “professional misconduct” is defined in s 139E. It means, in short, unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner’s registration (which can be established by the cumulative effect of more than one instance of unsatisfactory professional conduct). The notion of “unsatisfactory professional conduct” is itself defined in s 139B of the Law in relation to registered health practitioners generally, as added to by s 139C with respect to medical practitioners. In this matter the Commission had relied on two variants of unsatisfactory professional conduct, set out in s 139B(1)(a) and (l):
(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.
…
(l) Other improper or unethical conduct
Any other improper or unethical conduct relating to the practice or purported practice of the practitioner’s profession.
Neither set of reasons in the Tribunal referred to, let alone considered, the criterion of professional misconduct set out in s 139E in dealing with the Commission’s complaint. The section itself was only mentioned once, in passing, in the presiding member’s reasons at [2].
This Court has previously warned about relying on past case law relating to differently expressed statutory standards in considering whether medical practitioners have engaged in professional misconduct under the Law: Chen v Health Care Complaints Commission (2017) 95 NSWLR 334; [2017] NSWCA 186 at [59]-[75] (Payne JA), note also at [4]-[20] (Basten JA), and [23] (Leeming JA agreeing with both). It appears the warning was not heeded in this matter. It is axiomatic that in considering whether or not a medical practitioner has engaged in professional misconduct the Tribunal must identify and apply the correct test. The Tribunal failed to do so here.
The background to the matter is set out in the reasons of Adamson JA at [116]-[171]. We will address the three issues identified above in turn. Before doing so, it is appropriate to say something as to how reasons written by non-lawyers should be read and reviewed when challenged by way of appeal or judicial review.
When hearing complaints against medical practitioners the Tribunal is required to be constituted by a member of the Occupational Division of the Tribunal who is a senior judicial officer (as defined in s 165), two health practitioners selected for appointment by the relevant Council who are registered in the same health profession as the practitioner in question, and one lay person: Law, s 165B(2); CAT Act, Sch 5, cll 12-13. If the members are evenly divided on a decision (other than a decision of law) then the opinion of the presiding, legal member prevails: CAT Act, s 57(3)(a). Otherwise, for such non-legal decisions, the opinion of the majority prevails: CAT Act, s 57(1). For the Tribunal to be divided in opinion, and for the presiding judicial member to be in dissent, is relatively unusual in disciplinary matters. However, it is appropriate and important that all members diligently come to their own views.
It is also appropriate that when a court comes to review reasons given by members of the Tribunal who are not lawyers, that characteristic is borne in mind. In its submissions the Commission quoted a statement that a specialist tribunal “consisting of persons inexperienced in the formulation and use of legal language ought not be expected to craft reasons for judgment in the style of ‘a Brennan’ or display the verve and reasoning power of ‘a Denning’”: Seablest Pty Ltd v Smith (1996) 91 LGERA 1 at 4. So much may be accepted. Compressed reasoning, unusual structuring, infelicities of language, inaccurate use of legal phrases, or such like may simply reflect the nature, training and experience of the author.
Nevertheless, medical and lay members of the Tribunal are still required to give legally adequate reasons. Section 165M of the Law requires the Tribunal to “give a written statement of the decision”, which statement must set out any findings on material questions of fact, refer to any evidence or other material on which the findings were based, and give the reasons for the decision. Failure to give adequate reasons may suffice to uphold an appeal in such matters: eg Ghosh v Health Care Complaints Commission (2020) 104 NSWLR 107; [2020] NSWCA 353 at [128]-[151]. The reasons must be sufficient to enable a court to see whether the opinion does or does not involve any error of law: note analogously Wingfoot Australia Partners Pty Ltd v Kocak (2013) 252 CLR 480; [2013] HCA 43 at [54]; New South Wales Land and Housing Corporation v Orr (2019) 100 NSWLR 578; [2019] NSWCA 231 at [71]-[73]. Given the serious nature of the issues and the potential consequences, there may be little difference in substance from the duty of a court to give reasons: Gautam v Health Care Complaints Commission [2021] NSWCA 85 at [55].
The Commission sought to emphasise the oft-cited approval by a plurality of the High Court in Minister for Immigration and Ethnic Affairs v (1996) 185 CLR 259; [1996] HCA 6 of statements by the Full Court of the Federal Court in (1993) 43 FCR 280 at 287 and (1992) 28 ALD 609 at 616. The plurality in the High Court said (at 272, citations omitted):
it was said [in Pozzolanic] that a court should not be “concerned with looseness in the language … nor with unhappy phrasing” of the reasons of an administrative decision-maker. The Court continued: “The reasons for the decision under review are not to be construed minutely and finely with an eye keenly attuned to the perception of error.”
These propositions are well settled. They recognise the reality that the reasons of an administrative decision-maker are meant to inform and not to be scrutinised upon over-zealous judicial review by seeking to discern whether some inadequacy may be gleaned from the way in which the reasons are expressed [citing McAuliffe].
Justice Kirby made similar points in Liang at 291, also citing Pozzolanic. As his Honour said there: “The reasons under challenge must be read as a whole. They must be considered fairly”. The plurality’s judgment in Liang is consistent with taking that approach (see eg at 280).
In Pozzolanic the statement (at 287) about avoiding an “eye keenly attuned to the perception of error” was itself supported by a reference to an earlier judgment of Lockhart J in Politis v Commissioner of Taxation (Cth) (1988) 16 ALD 707 at 708. It is worth noting what his Honour then went on to say in that case after having deployed that phrase (ibid):
the court should approach its task sensibly and in a balanced way, not reading passages from the reasons for decision in isolation from others to which they may be related or taking particular passages out of the context of the reasons as a whole.
Consistently with approaching the task in a sensible and balanced way, a beneficial approach to reasons does not demand that any ambiguity be resolved in favour of the decision-maker: see SZCBT v Minister for Immigration and Multicultural Affairs [2007] FCA 9 at [26] (Stone J); approved eg Communications, Electrical, Electronic, Energy, Information, Postal, Plumbing and Allied Services Union v Abigroup Contractors Pty Ltd [2013] FCAFC 148 at [190]; Allianz Australia Insurance Ltd v Rutland [2015] NSWCA 328; (2015) 73 MVR 211 at [26]; Minister for Home Affairs v Ogawa (2019) 269 FCR 536; [2019] FCAFC 98 at [116].
The Court’s review of the reasons of a decision-maker should not proceed in a manner inclined to finding error. But that does not mean the Court must strive to read the reasons in such a way as to avoid the conclusion of error. For example, it is not for the Court to fill gaps in reasons by speculating about what further unarticulated considerations, if any, lie behind what the decision-maker said. The Court’s duty is to read the reasons fairly and as a whole, making due allowance (where relevant) for the fact that the authors are not lawyers accustomed to writing in a legal manner.
[111] … To the extent that it has been suggested, albeit not as part of a particular of any complaint against her, that the Practitioner has in some way financially benefitted from directly dispensing medication to her patients, the evidence does not establish that any such prescribing has been unlawful or intended to have, or have had, any actual or likely financial benefits for the Practitioner, or any inappropriate financial benefits for her patients.
…
[169] The Commission further submitted that the Practitioner directly purchasing products from the supplier (spending almost over $25,000 per month) and directly dispensing the product to patients (even if it was at cost price) significantly impacted her clinical objectivity with respect to Somatotropin and her consideration of it on a case by case basis. Given that there is no issue that the Practitioner made no money out of those transactions, I am unable to accept that, although ill advised, the Practitioner’s could reasonably have impacted upon her clinical objectivity.
(ix) the claim that there was anything sinister associated with the Practitioner’s prescribing or direct dispensing of off-label medication has not been established to my comfortable satisfaction, either with respect to the practice itself or any asserted financial implications of it. The Commission has not in my view proved that the Practitioner attempted to “veil” any inappropriate conduct with respect to prescribing or dispensing off-label medication;
…
(xi) the evidence does not in my view establish that, whatever the shortcomings in her prescribing and management of off label medications, the Practitioner’s objectivity or judgement was compromised by financial or any other considerations; …
Financial incentives
[313] In relation to paragraph 65, 111 and 169, the practitioner was spending around $25,000 per month on somatropin (see paragraph 176) and it is plausible that this expensive level of ongoing inventory may have impacted her objectivity as it would have generated considerable pressure on the practitioner to maintain the turnover of her stock of somatropin.
[314] Prescribing and dispensing a restricted substance at cost would be a substantial financial incentive for many patients to consult with the practitioner, thereby raising the number of patients attending her consultations. This view is contrary to the view expressed by his Honour at paragraph 169. There were no receipts issued by the practitioner in evidence and we had to rely on oral evidence from the practitioner in regard to the costs of consultations and prescriptions issued by her.
(ix) “Sinister” or “veil” were terms that were not included in the particulars and hence not relevant to these proceedings;
…
(xi) Disagreed. The practitioner paid for and stored some $25,000 of Somatropin per month which she dispensed directly to patients. Paying for and storing such a valuable inventory would have been reason to prescribe and create turnover of this inventory thereby influencing her objectivity in prescribing; …
The nature of the concern expressed by the Majority at [313] is somewhat difficult to understand. As the presiding member alluded to, by the end of the hearing below it did not seem to be disputed that the appellant was dispensing the HGH at cost price, although that had not been the Commission’s understanding at the commencement of the case. The Majority seemed to imply that there was some pressure on the appellant to dispose of a large stockpile, perhaps because it had a limited shelf life, or because it needed to be purchased by her in some large amount. But no such evidence was identified. And it was not how the Commission put its case. The Majority’s view, as espoused in [313], that it was “plausible that this expensive level of ongoing inventory may have impacted her objectivity” was speculative. This speculation was never put to the appellant and was translated by the Majority into a positive conclusion (“thereby influencing her objectivity”) in [355(xi)].
In its closing written submissions the Commission had noted that the appellant spent around $29,000 per month purchasing HGH (it seems that the Tribunal’s references to $25,000 were mistaken). It said it could be inferred that for her “to have spent that much per month, she saw benefit in this aspect to her practice”; this “would have affected her objectivity and judgment when determining whether it was clinically appropriate for her patient”; and that the appellant gained increased patronage from direct dispensing.
The appellant’s complaint is that the Majority denied her procedural fairness in finding that her objectivity was compromised as a result of financial pressure to turn over her stock of HGH when that was not part of any particularised complaint and had not been put to her. Senior counsel appearing for the appellant, Ms Mathur SC, acknowledged that the issue had been the subject of closing submissions in those terms before the Tribunal by both sides, and no objection on procedural fairness grounds had been made to the issue having then been raised. However, she effectively conceded this was an error on the part of the appellant’s legal team and the point should have been taken. As explained by Adamson JA below (at [161]), an unfortunate feature of this matter was that oral closing submissions occurred about a year after the evidence had been completed, with written submissions being supplied shortly before that final hearing. Ms Mathur argued that any lack of fairness was not cured by the chance to make submissions below, because the appellant herself should have been given the chance to deal with it in evidence. Any error in this respect by the appellant’s legal team in submissions below should not be held against the appellant. Senior counsel appearing for the Commission in this Court, Ms Heger SC, fairly accepted as much.
The starting point of the procedural fairness analysis must be the Amended Complaint which was before the Tribunal. Complaint One of the document relevantly alleged that the appellant was guilty of unsatisfactory professional conduct including because she “prescribed and inappropriately dispensed” HGH to Patients A-J on dates and in quantities particularised. Complaint Two related to inadequate record keeping. Complaint Three alleged that the conduct of the appellant taken as a whole constituted professional misconduct.
Dispensing the said medication privately and directly to patients, particularly in circumstances where it was prescribed for ‘off-label’ purposes without a clinical, scientific or medical basis.
This answer to the question did not suggest that the appellant had some financial or stockpile-related incentive relating to dispensing HGH which may have compromised her objectivity. Given that the Commission had not identified this issue either in its Amended Complaint or in its answer to a specific question seeking particulars, the appellant could reasonably have concluded that no such issue was being raised. Thus the presiding member made the point that the suggestion the appellant had in some way financially benefitted was “not … part of a particular of any complaint against her” (at [111]).
The Commission in this Court did not rely upon its actual answer to the direct question asked of it in the request for particulars. Rather, it said that the allegation was identified by way of the evidence and materials referred to in the third column of the table, as follows:
Dr Kertesz’s first report (tab 40), pages 33 and 34 considered with his answers in his supplementary report at page 19 and 20.
Professor Carter’s report (tab 47), page 7.
See also tab 73, 75 to 77: Professional Standards and Guidelines; tabs 80 to 89: prescribing and drug information
Dr Della Bruna stepped outside standard prescribing by prescribing off label, she dispensed the Somatropin to patients in lieu of referring for Pharmacy prescribing, and she did so outside the safety guidelines in her purchasing, storing, selling, prescribing, dispensing, and delivering Somatropin to her patients. She made note of the prescribing of the medication and then made notes in dispensing records with respect to the Somatropin in which she was dealing. The only reference in the patients notes as to the potential or possible side effects or unwarranted effects to her dispensing of the Somatropin was a reference in most cases to “pros and cons discussed”.
Her behaviour in this manner of prescribing dispensing and the attraction of a fee for the medication delivered to the patient brings her conduct to be below the standard expected of a practitioner of equal training and experience. Her behaviour was significantly below that standard.
The Commission sought to emphasise the words “the attraction of a fee for the medication delivered to the patient”. Yet the obvious meaning of what Dr Kertesz was referring to was that the appellant would profit by receipt of the fee for the act of providing the HGH. That was a natural assumption for him to make when preparing his reports. In fact it was wrong; the appellant was dispensing the drug at cost price. Senior counsel for the Commission submitted that there were a “number of different ways you might read this”, and it “could” be understood to mean that the appellant “has a consultation, it’s prescribed and given to the patient in the context of that consultation, so we say that language is broad enough to encompass the consultation fee itself”. We regard that reading as contrary to the ordinary connotation of the words used, understood in context.
The other material the Commission had identified was at p 7 of Professor Carter’s report, where this was said (emphasis added):
It is apparent from the clinical notes provided to me that Dr Della Bruna was not prescribing Somatropin for [growth hormone] deficiency. The actual reasons given varied from improvement in cognition, well-being, memory, concentration, sleep patterns, energy, wound healing & pain relief. Somatropin has not been proven (in double blind, placebo controlled trials) to be of benefit in any of these situations. Aside from possible financial considerations, it is difficult to understand why Dr Della Bruna apparently personally dispensed Somatropin rather than arranged for dispensation from a Pharmacy.
The words “aside from possible financial considerations” were struck out of the report by the presiding member at a preliminary hearing on 18 October 2022 as being “gratuitous”, which can be understood in context as also meaning speculative. Senior counsel for the Commission noted that those words had not been struck out at the time its response was sent (on 21 September 2022) and described those redacted words in this Court as “a suggestion, and I accept a fairly vague one, that she might have had some financial motivation for prescribing these drugs”. The words were, indeed, vague at best.
The Court was also taken to some cross-examination of the appellant by counsel then appearing for the Commission. The relevance of cross-examination to the current dispute is open to argument. Although the questions were not objected to, the nature of the case to be met should have been articulated prior to the appellant giving evidence. In any event, we do not consider the cross-examination advances the Commission’s argument. It was put to her that being able to obtain the HGH at cost price would have been an attraction to patients. But it was not suggested to her, let alone squarely, that she had a financial incentive to prescribe the drugs, that she had some need to run down a stockpile of drugs, or that either of those imperatives had compromised her objectivity in deciding what to prescribe.
It is notable that the culmination of the cross-examination on this topic constituted suggesting to the appellant that her explanations for direct dispensing (most notably being patient embarrassment) was not true, and rather that “the reason that you sought to directly dispense somatropin was to reduce the risk of oversight or investigation about it”. It is telling that senior counsel now appearing for the Commission said of this denouement, “[t]o that extent clearly her explanation for the direct dispensing is being put in issue” (emphasis added). And the extent her explanation was there being put in issue does not encompass financial or stockpile related incentives.
The Commission then sought to make something of the fact that the General Member asked some questions of the appellant, in the course of which the member referred to p 20 of Dr Kertesz’s supplementary report. The member’s questions about that page dealt with the distinct issue of safety guidelines. Any suggestion that procedural fairness was provided by some questioning by a member about a different topic, which questioning happened to touch on a page of evidence that the Commission now relies on, where the questions did not address the topic at hand, is as surprising as it is devoid of merit.
Drawing these matters together, part of the Majority’s reasoning was that the appellant had some financial or stockpile-related incentive to maintain turnover of her stock of HGH, which incentive may have impacted or did impact her objectivity in deciding to prescribe and dispense that drug. This was not alleged as part of the Commission’s case where it should have been, being the Amended Complaint. It was not stated in terms in the letter providing further particulars. The best that the Commission could point to was parts of two reports which were referred to in that letter. The natural reading of part of one sentence that the Commission relied upon in the first report (the supplementary report of Dr Kertesz) was not to the point. As for the report of Professor Carter, the relevant five words relied on were in fact struck out of the report prior to the final hearing as being gratuitous and speculative, and those words in any case did not actually articulate the allegation at issue. At best those words made some vague and speculative wave towards there being some financial motivation of an unstated kind.
As noted, the Commission’s second complaint in the proceedings below was that the appellant was guilty of unsatisfactory professional conduct by failing to make and keep adequate records in relation to Patients A to J. The appellant admitted the allegation, without necessarily admitting all of the particulars. No issue arises about that complaint on this appeal. What does arise is an issue about the view the Majority took of the appellant’s oral evidence with respect to her treatment of the patients, in light of the admitted inadequacy of her records.
The Majority said as follows:
Patient records
[342] In relation to paragraph 116, his Honour stated that the practitioner: “was able to explain why she had prescribed particular medications, and the dosages which she had prescribed.” However, the patient records did not contain any of the information that the practitioner provided in oral evidence during the hearing.
[343] The Medical Board Good medical practice: a code of conduct for doctors in Australia at section 10.5 states that it is essential for the continuing good care of patients to keep accurate up-to-date and legible records that report relevant details of clinical history, clinical findings, investigations, diagnosis, information given to patients, medications, referral and another management of the patient in the form that can be understood by other health practitioners. This is consistent with the opinion of Dr Kertesz.
[344] The evidence of what occurred or what was undertaken at the time of the consultation is contained in the patient record. Oral evidence pertaining to specific consultations, some three or four years later, cannot replace a patient record which has been contemporaneously recorded and accordingly we reject the practitioner’s oral evidence on these points. If it is not in the patient record then the actions, justifications and monitoring did not occur despite the practitioner’s ex post facto assertions. This view is not limited to the paragraphs listed here but applies to his Honour’s decision as a whole. (e.g. paragraph 209, 235, 240)
(iv) The Tribunal accepts the Medical Board Code of Conduct and specifically paragraph 10.5 of that document which requires that contemporaneous complete and accurate medical or patient records be maintained. Oral evidence, some four years after a consultation with a patient, from the practitioner pertaining to specific consultations in lieu of entries in the patient record are rejected by the Tribunal;
…
(vi) The Tribunal rejects the practitioner’s oral evidence in relation to her prescribing and management of the ten patients who were the subject of the complaint. Patient records are required to be made contemporaneously and in accordance with 10.5 of the Code of Conduct. Ex post facto assertions in respect of patient consultations that occurred some four years prior are inherently unreliable.
the Practitioner gave detailed evidence in cross-examination by Counsel for the Commission and, significantly, in response to probing questions by the Tribunal, particularly by the two Medical Members of the Tribunal. Although in cross-examination Counsel for the Commission disputed that the Practitioner had done certain of the things which she claimed she had, there is in my view no reason to reject the Practitioner’s claims with respect to what she did in the course of prescribing or managing off-label medications for the ten patients the subject of these proceedings …
The presiding member was correct to indicate that the appellant gave detailed oral evidence with respect to what she did in the course of prescribing and managing off-label medications for the ten patients. In so doing it is apparent that she was referring to her records then seeking to add further information from her memory.
The appellant made this submission:
The Majority does not articulate any basis to reject or doubt the practitioner’s evidence other than a global assertion (at [355](vi)) that the passage of time makes her ‘assertions … inherently unreliable’. It is the experience of Tribunals and Courts at every jurisdictional level that witnesses are asked to (do, and can) recall matters which took place years, sometimes decades, prior to their occurrence, in the absence of contemporaneous documentation. The suggestion that something ‘did not occur’ merely because it was not written down in a contemporaneous record is both irrational and unreasonable.
We agree.
Senior counsel for the Commission sought to defend the reasoning at [344] in these terms:
So the reasoning here is not simply, “If it’s not in the records, we reject it.” It’s that she is purporting to give oral evidence some four years after the relevant consultation about discussions she had with patients and the majority is saying, “It’s an ex post facto assertion given four years after the event. We find it to be an unreliable account.”
This attempted explanation prompts the obvious question: why did the Majority find it to be an unreliable account? It was of course open to the Majority to reject the extensive evidence of the appellant, in whole or in part, as being unreliable or not credible. But to do so requires reasons. Giving such reasons is not mere verbiage; it is a critical step in explaining a conclusion.
For example, the Majority might have referred to any inconsistencies or contradictions in her evidence; identified some examples of what she said that was unreliable; given instances where her claimed memory was shown to be contrary to something in a record; or expressed the view that the appellant’s demeanour whilst giving evidence cast doubt over what she said. It is conceivable that the Majority considered that her evidence was so replete with guesses and admissions as to lack of recollection as to be completely unreliable. Yet the Majority made no such suggestion. To infer that any one of these possible explanations was the Majority’s real reason, beyond the reasoning they actually expressed, is speculative.
Consistently with what has been explained above at [12]-[16], it is not the role of a Court on appeal or judicial review to assume that there must have been some good reason for any conclusion reached and, on that assumption, then to conclude that the failure to give a rational reason manifests no error. Doing so is circular. Where a judge is “bound to state the reasons for arriving at the decision reached, the reasons actually stated are to be understood as recording the steps that were in fact taken in arriving at that result”: Waterways Authority v Fitzgibbon [2005] HCA 57; (2005) 79 ALJR 1816 at [130] (Hayne J). This principle has been applied to administrative decision-makers who are obliged to give reasons: D*’*Amore v Independent Commission Against Corruption [2013] NSWCA 187; (2013) 303 ALR 242 at [101]-[105] per Beazley P, Bathurst CJ agreeing at [1]. It applies here.
Having noted at [342] that the appellant’s oral evidence went beyond what was contained in the patient records, the only reasons the Majority gave for its wholesale rejection of the appellant’s evidence on point were as follows:
Section 10.5 of the Medical Board’s Code of Conduct states that it is essential for the continuing good care of patients to keep accurate up-to-date and legible records (see [343] and [355(vi)]).
Oral evidence “pertaining to specific consultations, some three or four years later, cannot replace a patient record which has been contemporaneously recorded and accordingly we reject the practitioner’s oral evidence on these points” (at [344]).
“Ex post facto assertions in respect of patient consultations that occurred some four years prior are inherently unreliable” (at [355(vi)]).
[301] As this information was largely missing from the patient records, it can be said that the practitioner did not undertake initial or subsequent assessment relevant to the side effects listed by Professor Carter with respect to the ten patients in this case.
This statement illustrates much the same reasoning process: if something was not recorded in the notes, it did not occur. A similar point seems to have been made at the end of [331].
The Commission argued that the Majority’s reasoning at [344] and [355(vi)] was not directed to the appellant’s evidence as a whole but rather to her evidence about particular consultations. It can be accepted that the Majority was dismissing the relevance of all of the appellant’s extensive oral evidence about all of her numerous consultations with all of her ten patients over a period exceeding two years. That was no minor step. The Commission’s point does nothing to answer the criticisms made of the reasoning.
The Majority’s approach involved error that can be expressed in various ways. Reversal of onus of proof (ground 2) might be a way in which the error could be expressed. Regardless, it was certainly a legal error by failure to give adequate, intelligible or logical reasons (raised by ground 6). It was also a constructive failure to exercise jurisdiction insofar as it involved a failure to grapple with a substantial and clearly articulated aspect of the appellant’s case (raised by ground 4). That type of error can also be expressed in terms of procedural fairness (as raised by ground 5(b)): Dranichnikov v Minister for Immigration and Multicultural Affairs [2003] HCA 26; (2003) 77 ALJR 1088 at [24].
(a) The [appellant] did not seek blood tests to measure the IGF-1 levels in any patients to whom she prescribed human growth hormones.
(b) Evidence of ‘ongoing monitoring’ was ‘missing’ from the [appellant’s] patient records.
The appellant accepted that it required leave to appeal from these findings of fact.
[297] We note that the practitioner has not undertaken IGF1 blood tests to determine if any of the ten patients had an excessive of growth hormone, which would be germane to the protection of the health and safety of these patients.
…
[328] … We note that in the ten patient records produced in relation to this matter, the practitioner has not sought blood tests to measure the IGF1 for any of the patients. In these circumstances, continuing to prescribe HGHs to these patients, without the appropriate serological monitoring amounts to serious negligence.
…
[331] … During oral evidence, Professor Holmes-Walker stated that in the past she had prescribed “off label” HGH for patients with serologically identified partial human growth deficiencies. However, unlike the practitioner, Professor Holmes-Walker prescribed an individualised starting dose based on the patient’s weight, titration of growth hormone over several weeks based on safety, efficacy and tolerability. In addition, Professor Holmes-Walker conducted ongoing monitoring at least six months with IGF-1, lipids, glucose, blood pressure, weight and body mass index. All of these considerations are missing from the practitioner’s patient records.
…
[355] In relation to paragraph 255 and his Honour’s findings, the following responds to his Honour’s subparagraphs as follows:
(i) while there were no patient complaints there was a mandatory notification from the PRU to the Medical Council which resulted in conditions on the practitioner’s registration prohibiting the prescribing of HGHs;
(ii) and (iii) Professor Carter identified side effects in patients B and C that he attributed to excess growth hormone. Professor Carter’s evidence was that there was potential for significant side effects in the prescribing of HGHs. Considering the prolonged treatment periods that averaged over 17 months for the ten patients, any potential side effects would have gone unmonitored because of the absence of IGF1 serological analysis… (emphasis added)
The appellant argued that the Majority erred in fact at [297], [328], [331] and [355] because the evidence before the Tribunal highlighted that the appellant did conduct IGF-1 tests for patients who were prescribed HGH and that “ongoing monitoring at least six months with IGF-1, lipids, glucose, blood pressure, weight and body mass index” were not considerations wholly missing (“all are missing from the practitioner’s patient records”) as asserted at [331].
Senior counsel for the Commission, although opposing the grant of leave, accepted that if the Court acceded to the appellant’s complaint that, on their fair and proper reading, these paragraphs disclosed that the Majority proceeded on an incorrect factual basis and these factual errors were material, there was nothing that she could say against leave to appeal being granted. So much was consistent with what Griffiths AJA recently observed in Kavieris v Health Care Complaints Commission [2025] NSWSC 20 at [116]:
While a misunderstanding or mistake as to evidence does not generally constitute an error of law…, it may appropriately be described as an error in fact finding. In a jurisdiction such as that under cl 29(4)(b) of Sch 5 of the CAT Act where the error in fact finding is sufficiently serious and causes a substantial injustice, leave to appeal may be granted and the error identified.
For the reasons that follow, we are comfortably satisfied that the Majority proceeded on a seriously incorrect factual basis as to the testing and monitoring that was undertaken by the appellant of Patients A-J, that this error was material, that leave to appeal should be granted and that ground 7 of the appeal should be upheld.
The natural reading of the four paragraphs set out at [65] above support the appellant’s contention. Senior counsel for the Commission conceded that the language employed by the Majority was “imperfect”, argued that it amounted to the Majority simply saying, not that IGF-1 tests had not been undertaken, but that the appellant had not evaluated blood tests that had been undertaken. She continued:
HEGER: … We say all the majority is saying in 297, and it is imperfect, but all they’re saying is not that she never once did in IGF test, but that once somatotropin had been prescribed you don’t see IGF tests on a regular basis for this purpose of assessing whether any of the patients had excessive growth hormone.
BELL CJ: Why would you order the tests unless you were going to assess them?
HEGER: That’s a legitimate question to be asking. The point is that there was no evidence of her then subsequently conducting that assessment in the clinical records.
The Commission’s submission and the interpretation sought to be placed on the Majority’s language in [297] simply cannot be reconciled with what appears shortly after in the Majority’s reasons at [328], namely that “the practitioner has not sought blood tests to measure the IGF1 for any of the patients”. Moreover, the Majority in [328] implicitly equated the ordering of blood tests as at least part of what was “appropriate serological monitoring”. Further, as shall be shown, there was evidence of subsequent assessment of various tests that had been ordered.
Ms Heger was constrained to make the submission she did because the contemporaneous clinical records made by the appellant and which were before the Tribunal highlighted that the appellant had in fact conducted IGF-1 testing for patients A-J. Specifically, the contemporaneous clinical records showed that the appellant conducted IGF-1 testing, and recorded the test results, including for:
Patient A on 18 March 2019;
Patient B on 5 February 2019;
Patient C on 11 February 2019, recording the results of a pathology report dated 22 January 2019;
Patient D on 26 July 2019, recording the results of a pathology report dated in the same month, and a further IGF-1 result entered in the clinical records on 16 October 2019;
Patient E on 9 October 2016, 17 January 2018 and 16 October 2019;
Patient F on 17 October 2017, 24 October 2018 and 19 October 2019;
Patient G on 12 April 2016, recording the results of a pathology report dated 23 February 2016 and 1 July 2019;
Patient H on 18 July 2017;
Patient I on 27 June 2018; and
Patient J, a pathology report dated 17 April 2018 highlighted that the patient’s IGF-1 levels had been tested.
The appellant noted that Dr Kertesz’s first report expressly acknowledged that the appellant conducted IGF-1 tests in relation to patients A, B, C, D, E, G and I. As noted above, IGF-1 tests were also recorded by the appellant for Patient F, and conducted for Patient J. The appellant explained in cross-examination that she conducted IGF-1 tests:
Q. In your answer you said blood tests would show their IGF-1s went up?
A. Yes.
Q. Are you suggesting that there was ongoing monitoring of hormone assessments?
A. Yes.
Q. In relation to each of those patients?
A. I believe so.
Q. On 17 January 2018, sorry did you do a blood test?
A. Yep. Half way down. Has had bloods done at local GP. Of note DHEA 1. Ferritin 40. IGF-I 17. Otherwise NAD. (emphasis added)
The appellant’s evidence was corroborated by her clinical records, as noted above. The Court was asked to infer that NAD was shorthand for “no adverse developments”, and this was not contested by the Commission. Implicit in the expression was the monitoring by the appellant of her patients. References to “NAD” were made throughout the appellant’s clinical records for patients A-J:
Patient A on 12 October 2017 in relation to “CNP” and 26 October 2017 in relation to “bloods”;
Patient B on 9 January 2018 in relation to “CNI;
Patient C on 21 January 2019 in relation to “TML;
Patient D on 9 March 2017 in relation to “ENT”;
Patient E on 14 September 2016 in relation to “CNI” and “ANI” and on 17 January 2018 in relation to blood results;
Patient F on 3 October 2017 and 24 October 2018 in relation to a panendoscopy;
Patient G on 16 March 2016 in relation to “CNI/DNI”;
Patient H on 23 June 2016;
Patient I on 18 December 2017 in relation to “ANI” and “CNI”, 15 August 2018 in relation to “ENT” and an endoscopy; and
Patient J on 18 June 2018 in relation to an “ECG”.
The Majority’s erroneous finding that no IGF-1 testing was sought or occurred was material to its reasoning process. Thus, at [328], immediately following its erroneous statement that “in the ten patient records produced in relation to this matter, the practitioner has not sought blood tests to measure the IGF1 for any of the patients*”**,* the continued prescription of growth hormones without monitoring for IGF-1 was described as “serious negligence”.
The materiality of the factual errors in the Majority’s reasoning may also be seen in its emphatic statement at [331] with regard to monitoring of IGF-1, lipids, glucose, blood pressure, weight and body mass index. The Majority said emphatically and unambiguously that “*[a]ll of these considerations are missing from the practitioner’*s patient records”. This sweeping and damning statement was fundamentally erroneous. We have already noted the often multiple references to IGF-1 tests in the patient records. But there are even more and regular entries for the measurement of blood pressure (BP), height and weight, for example. Patient A’s records, for example, record separate blood test results on three occasions, blood pressure results on six occasions as well as weight being regularly tested. Such measurements occurred even more often for many of the other sample patients, on regular occasions. There are also entries in these notes for testing of lipids and glucose (see patients B, C, D, E).
The Tribunal was careful in its reasons to qualify its finding that the appellant failed to order tests by purpose (to determine whether there was growth hormone deficiency) and by time (before she prescribed any Somatropin). To read its reasons otherwise is to fail to give each word its meaning in the sentence and in context. The qualifying words as to purpose and time are there because they have work to do. The Tribunal can be taken to be aware that the appellant conducted IGF-1 tests from time to time on her patients: it did not find to the contrary. But what it did find is that those tests were not done for the required purpose. This finding, far from being erroneous, was entirely uncontroversial. The appellant admitted that she had not done any such tests for that purpose before she prescribed Somatropin and maintained that it was not necessary that they be done. The Tribunal was entitled to accept that admission. (emphasis in original.)
With respect to her Honour, we cannot agree. This is so for a number of reasons.
First, the statement – “[t]he Tribunal can be taken to be aware that the appellant conducted IGF-1 tests from time to time on her patients: it did not find to the contrary” – cannot be reconciled with the Majority’s unambiguous statement at [328] that “the practitioner has not sought blood tests to measure the IGF-1 for any of the patients” (our emphasis). The Majority’s factual error was confirmed by its subsequent statement at the conclusion of [331] about the considerations said “all” to be “missing from the practitioner’s patient records”.
Second, the Majority did not qualify its statement in [297] by reference to considerations of “time (before she prescribed any Somatropin)”, contrary to Adamson JA’s suggestion. Nothing in [297] supports her Honour’s statement that “[t]he Tribunal was careful in its reasons to qualify its finding that the appellant failed to order tests …. by time (before she prescribed any Somatropin)”. Indeed, the context is to the contrary: the Majority referred to Professor Carter’s concern to monitor for medical conditions “exacerbated by excess growth hormone such as somatropin”: [296]. The “identification of side effects” could only occur by testing after administration of the drug to particular patients. This was consistent with how the Commission puts its case on appeal. Thus Ms Heger submitted:
We say all the majority is saying in 297, and it is imperfect, but all they’re saying is not that she never once did in IGF test, but that once somatotropin had been prescribed you don’t see IGF tests on a regular basis for this purpose of assessing whether any of the patients had excessive growth hormone.” (emphasis added)
The appellant admitted that she had not done any such tests for that purpose before she prescribed Somatropin and maintained that it was not necessary that they be done. The Tribunal was entitled to accept that admission.
I DISPUTE THAT IT WAS NECESSARY TO ORDER GLUCOSE/INSULIN TESTING TO DETERIMINE GROWTH HORMONE DEFICIENCY PRIOR TO PRESCRIBING FOR THIS PATIENT[.] GROWTH HORMONE DEFICIENCY WAS NOT WHAT WAS BEING TREATED. THE HGH MEDICATIONS WERE BEING USED “OFF LABEL” AND THE PATIENT WAS FULLY INFORMED OF THIS, AND OF THE RISK AND POSSIBLE BENEFITS, AND WAS HAPPY TO HAVE THIS REGIME PRESCRIBED. TO SEND THIS PATIENT FOR SUCH INVESTIGATIVE TESTING WAS NOT INDICATED.
This passage in terms is directed to testing prior to prescription of Somatropin. It would only assume significance if that is what was being addressed in [297]. For the reasons given above, it was not.
Second, the Tribunal did not “accept” any such admission (even if it is correct to refer to it as an admission: cf Laws v Australian Broadcasting Tribunal (1990) 170 CLR 70 at 86; [1990] HCA 31). The Majority did not even refer to this aspect of the appellant’s Reply in its reasons nor was it relied upon in the Commission’s oral or written submissions below.
Third, what Adamson JA has referred to as the appellant’s admission contained in her Reply to the Commission’s Complaint was not referred to nor relied upon by the Commission in its submissions before this Court. The appellant was not given an opportunity to be heard in relation to the significance which it appears to assume in her Honour’s reasons.
Finally, we note that in relation to ground 7(b), her Honour appears implicitly to accept that the Majority’s erroneous statement that “All of these considerations are missing from the practitioner*’*s patient records” was not correct, and that “the appellant conducted some testing of her patients”: see [298] below. In rejecting this ground of appeal, however, Adamson JA referred to evidence of Associate Professor Holmes-Walker as to the frequency with which such tests should occur, suggesting that such testing as the appellant did undertake did not meet what was required. Thus, her Honour states that:
The appellant’s expert, Associate Professor Holmes-Walker said that monitoring of patients to whom HGH had been prescribed must be undertaken at intervals of no more than six months and must involve testing of the markers referred to by the Tribunal at [331].
Every six months, I think was her evidence, although [she] then accepted perhaps it could be done after a few months and then maybe after a year, but certainly there needs to be some sort of repeat regular monitoring and that there needs to be some evaluation of it.
Professor Holmes‑Walker had said there needs to be an initial assessment after a few months and then her gold standard was after six months, but she accepted maybe then a year after would also be acceptable. (emphasis added)
Q. By your answer, I take it that you have chosen to undertake some pathology and blood tests in order to conduct a proper surveillance of it.
A. So, I think I indicated that certainly in older individuals - but certainly anyone on growth hormone I’m going to monitor their IGF1. I’m going to regularly monitor that and make sure that’s not progressively increasing and increasing and increasing.
Q. Regularly monitor—
A. IGF1.
Q. But how often?
A. I think - so, as I said, I would do it at three-month mark and then I would think at a minimum annually. My patients are coming six monthly and I tend to do their tests six monthly, but I think annually would also be sufficient. (emphasis added.)
In any event, while not all of the marker tests may have been undertaken at six monthly intervals, many were undertaken more regularly and certainly within 12 month periods.
The Majority proceeded, however, on the basis that there was no monitoring whatsoever: “all of these considerations are missing from the practitioner*’*s patient records”. This is the gravamen of the appellant’s complaint. There was no analysis by reference to the evidence as to the adequacy of the monitoring and testing that was in fact done. This would have had to have occurred in order for the Tribunal to form a view as to whether the practitioner’s conduct not only fell below the standard reasonably expected of a practitioner of an equivalent level of training or experience but did so to a significant degree.
The appeal must be upheld. The orders of the Tribunal which give effect to the Majority’s conclusion must be set aside. That will mean the Commission’s Amended Complaint remains undetermined.
The appellant sought that remittal be to a differently constituted Tribunal, save that it sought that the presiding member remain. Given that the Majority, at least on one view, has made credit and reliability findings in relation to the appellant, it is appropriate that the Tribunal be differently constituted on reconsideration. However, the appellant cannot pick and choose who will sit on that panel. There should be no exception for the presiding member.
It is open to the Court to make orders that the Tribunal’s reconsideration take place “either with or without further evidence”: CAT Act, Sch 5, cl 29(8)(d). We will leave the issue of how to proceed in the hands of the parties and the Tribunal. It would be open for the evidence received in the Tribunal’s hearing, including transcript of examination and cross-examination, to be tendered before the reconstituted Tribunal.
As for costs of the appeal, if the appellant had succeeded only on the procedural fairness issue then there would be something to be said for each side bearing its own costs, given that the point complained of could and should have been raised below in closing submissions. However, the appellant has succeeded on two further, independent grounds. In that context costs should follow the event.
The orders of the Court will be as follows:
Grant leave to appeal in relation to ground 7.
Appeal allowed.
The orders of the Tribunal made on 24 October 2024 are set aside.
The matter is remitted to the Tribunal, to be differently constituted.
The respondent is to pay the appellant’s costs of the appeal.
ADAMSON JA: Dr Albina Della Bruna (the appellant) appeals and seeks leave to appeal against a decision of the NSW Civil and Administrative Tribunal (the Tribunal) in its Occupational Division that she was guilty of professional misconduct within the meaning of that term in s 139E(b) of the Health Practitioner Regulation National Law (NSW) 2009 (the Law). All references to legislation in these reasons are to the Law unless otherwise indicated. References to the reasons of the Tribunal (being the joint reasons of the majority, which are taken to be the reasons of the Tribunal) and the reasons of the Principal Member (who was in the minority) will be indicated in my reasons by paragraph numbers in square brackets.
The definitions of unsatisfactory professional conduct and professional misconduct were central to the proceedings before the Tribunal and are central to this appeal. These terms are relevantly defined by the Law as follows.
Section 139B(1) defines unsatisfactory professional conduct of a registered health practitioner as including:
(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.
…
(a) unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner’s registration; or
(b) more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner’s registration.
In an amended complaint filed on 16 August 2022, the respondent, the Office of the Health Care Complaints Commission (the Commission), alleged three complaints against the appellant:
she was guilty of unsatisfactory professional conduct under s 139B(1)(a) of the Law in that she had:
(a) inappropriately dispensed Somatropin, a human growth hormone (HGH); (b) inappropriately prescribed Somatropin and other drugs to ten patients (Patients A-J) over a period of approximately two years from 2 June 2017 to 17 November 2019; and (c) failed to appropriately manage such prescriptions;
(the first complaint)
that she was guilty of unsatisfactory professional misconduct under s 139B(1)(b) of the Law as she had contravened a provision of the Health Practitioner Regulation (New South Wales) Regulation 2016 (NSW) (the Regulation) in that she had failed to make and keep adequate records in relation to Patients A-J, including creating records such that other practitioners would find it difficult to continue the management of the patients and which were illegible and difficult to decipher (the second complaint); and
she was guilty of professional misconduct under s 139E of the Law either because the first two complaints, when considered together, amount to conduct of a sufficiently serious nature to justify suspension or cancellation of her registration or because her conduct as alleged was of such a nature (the third complaint).
The Tribunal was constituted by Principal Member Coleman SC ADCJ (the Principal Member), Drs Badam and Newberry, both Senior Members, and General Member Ms Lovrovich (the General Member). Because the Tribunal was constituted by more than one member, it was open to the members who constituted the Tribunal to be divided in opinion, with the consequence that the opinion of the majority is taken to be the decision of the Tribunal: s 57 of the Civil and Administrative Tribunal Act 2013 (NSW) (the NCAT Act).
The Tribunal, by majority (the Senior Members and the General Member), found that the three complaints had been made out.
The Principal Member, who constituted the minority, considered that the appellant was guilty only of unsatisfactory professional conduct under the second complaint, which the appellant had admitted. Although the Principal Member found that the appellant’s conduct in respect of the first complaint fell below the standard reasonably expected of a practitioner of an equivalent level of training or experience, he was not satisfied that it fell significantly below that standard (as required by s 139B(1)(a), see below) and was, therefore, not satisfied that the first complaint had been made out ([264]-[266]).
In this appeal, the appellant challenges the Tribunal’s findings of unsatisfactory professional conduct (complaints 1 and 2) and the bases for such findings, as well as the finding that complaint 3 was made out. She seeks that the Tribunal’s orders be set aside and that this Court substitute the minority opinion of the Principal Member or, in the alternative, that the matter be remitted to the Tribunal constituted by the Principal Member and three members other than the Senior Members and the General Member. Further, and in the alternative, the appellant seeks an order that the matter be remitted to the Tribunal to be heard and determined by an entirely differently constituted tribunal.
1 The Majority erred in law by failing to apply the language of s 139B(1)(a) of the Law.
2 The Majority erred in law by failing to apply the onus and standard of proof.
3 The Majority erred in law by unreasonably and illogically rejecting the opinion of Associate Professor Holmes-Walker (an endocrinologist) that the appellant’s conduct was not significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience.
4 The Majority failed to exercise its jurisdiction by failing to consider and determine a substantial and clearly articulated argument, being whether or not the prescribing and dispensing of certain medication, in the doses and frequencies prescribed, for a ‘wellness’ or ‘anti-aging’ purpose, in the circumstances of the case, was significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience.
5 The Majority denied the appellant procedural fairness by:
(a) Finding that her ‘objectivity’ was compromised as a result of financial ‘pressure’ to turnover her stock of Somatropin, when that was not put to her;
(b) Rejecting the appellant’s oral evidence regarding her prescribing and management of patients on the basis that matters she gave evidence about ‘did not occur’, when that was not put to the appellant.
6 The Majority erred in law in failing to give adequate, intelligible or logical reasons for their decision that the appellant was guilty of unsatisfactory professional conduct, or professional misconduct as required by s165M of the Law.
7 The Majority erred in fact in finding that:
(a) The appellant did not seek blood tests to measure the IGF-1 levels in any patients to whom she prescribed human growth hormones.
(b) Evidence of ‘ongoing monitoring’ was ‘missing’ from the appellant’s patient records.
The appellant accepted that she needs leave to appeal in respect of ground 7 but contended that she did not require leave in respect of the balance of the grounds.
Ground 2 contains 9 sub-grounds, which have been extracted from the appellant’s written submissions and are identified and addressed below when the grounds are dealt with.
It is apparent from the clinical notes provided to me that [the appellant] was not prescribing Somatropin for GH [growth hormone] deficiency. The actual reasons given varied from improvement in cognition, well-being, memory, concentration, sleep patterns, energy, wound healing & pain relief. Somatropin has not been proven (in double blind, placebo controlled trials) to be of benefit in any of these situations. Aside from financial considerations, it is difficult to understand why [the appellant] apparently personally dispensed Somatropin rather than arranged for dispensation from a Pharmacy.
(Emphasis added.)
On 30 May 2022, the matter was listed in the Tribunal for pre-hearing argument (including for rulings on evidence) before the Principal Member. A portion of the transcript of that hearing is before this Court. Ms Mathur SC, who appeared with Ms Alderton on behalf of the appellant, in this Court, also appeared on behalf of the appellant in the Tribunal.
Of present relevance, Ms Mathur submitted to the Principal Member that, if the Commission sought to argue that the appellant’s motive for prescribing Somatropin was “to achieve financial gains as compared to clinical indication or incompetence” then this needed to be particularised. Ms Mathur also referred to a suggestion “that there is something untoward in relation to the manner in which the drugs were paid for”. Ms New, who appeared for the Commission, indicated that she had heard the submission and, in substance, would consider whether further particulars ought be provided. The Principal Member confirmed that, if the Commission were relying on such a motive, it ought be particularised.
Also at the hearing on 30 May 2022, the Principal Member ruled that much of the PRU report to the Medical Council (which appears to have accompanied its mandatory notification) was irrelevant and it was redacted accordingly. That portion of the transcript of 30 May 2022 was not reproduced for this Court. This matter is germane only to sub-ground (3) of ground 2.
For the purpose of your supplementary report, we ask you to assume that [the appellant] has purchased Human Growth Hormone (HGH) drugs directly from the wholesaler (SciGen Pty Ltd (SciGen)) at her own business cost, made that medication available to her patients at times and dispensed it directly to her patients at times. You will have seen this in her medical notes and material already provided to you. To that end we enclose a table entitled “Sales [Customer detail]” which contains data obtained from SciGen regarding [the appellant’s] purchase of HGH from 1 June 2018 to 20 June 2019 and we also enclose Wholesale order forms from SciGen for HGH ordered by the [appellant] on 29 April 2019, 15 May 2019 and 11 June 2019.
[The appellant] stepped outside standard prescribing by prescribing off label, she dispensed the Somatropin to patients in lieu of referring for Pharmacy prescribing, and she did so outside the safety guidelines in her purchasing, storing, selling, prescribing, dispensing, and delivering Somatropin to her patients. She made note of the prescribing of the medication and then made notes in dispensing records with respect to the Somatropin in which she was dealing. The only reference in the patients notes as to the potential or possible side effects or unwarranted effects to her dispensing of the Somatropin was a reference in most cases to “pros and cons discussed”.
[The appellant’s] behaviour in this manner of prescribing dispensing and the attraction of a fee for the medication delivered to the patient brings her conduct to be below the standard expected of a practitioner of equal training and experience. Her behaviour was significantly below that standard.
(Emphasis added.)
On 16 August 2022, the Commission filed its amended complaint in the Tribunal in a form which indicated (by strike through and underlining) the changes which had been made to the complaint as originally filed on 8 February 2022. I understood it to be common ground that the amendments were, at least in part, responsive to further medical records having been provided by the appellant to the Commission since the filing of the original application and complaint. The appellant, by her solicitors, requested that a clean copy of the amended complaint be provided and filed. She also sought an extension of time to deal with the amended complaint. On 6 September 2022, the Commission filed a clean version of its amended complaint.
Of present relevance, the “Background to Complaint One” in the amended complaint included the following:
Between 1 June 2018 and 30 June 2019, the [appellant] purchased quantities of a schedule 4D drug, namely [Somatropin], directly from the wholesale supplier SciGen (Australia) Pty Ltd ….
The [appellant] is guilty of unsatisfactory professional conduct under section 139B(1)(a) or (I) of the [Law] in that the [appellant] has:
i. engaged in conduct that demonstrates the knowledge, skill or judgment possessed, by the [appellant] in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or
ii. engaged in improper or unethical conduct relating to the practice or purported practice of medicine.
| Patient | Time period of alleged inappropriate prescribing and dispensing of Somatropin | No of times Somatropin prescribed | Drugs which the appellant is alleged to have inappropriately prescribed | Drugs whose prescription the appellant is alleged to have failed to appropriately manage | | A | 12 Dec 2017 to 13 May 2019 | 9 | Somatropin Pregnenolone | Somatropin Pregnenolone Dehydroepiandrosterone (DHEA) | | B | 22 Mar 2018 to 6 Nov 2019 | 10 | Somatropin Testosterone Mesterolone | Somatropin Testosterone Mesterolone | | C | 11 Feb 2019 to 4 Nov 2019 | 5 | Somatropin Anastrozole | Somatropin Anastrozole DHEA | | D | 2 June 2017 to 16 Oct 2019 | 9 | Somatropin Progesterone + DHEA + Triest | Somatropin Progesterone + DHEA + Triest | | E | 11 Apr 2018 to 16 Oct 2019 | 7 | Somatropin | Somatropin | | F | 8 Nov 2017 to 17 Nov 2019 | 12 | Somatropin | Somatropin | | G | 13 Mar 2018 to 4 Nov 2019 | 11 | Somatropin Testosterone + DHEA | Somatropin Testosterone + DHEA | | H | 3 Oct 2017 to 14 Oct 2019 | 13 | Somatropin Testosterone + DHEA + Mesterolone | Somatropin Testosterone + DHEA + Mesterolone | | I | 23 Apr 2018 to 7 Nov 2019 | 10 | Somatropin Mesterolone Anastrozole Fluoxetine Pregnenolone | Somatropin Mesterolone Anastrozole Fluoxetine Pregnenolone DHEA | | J | N/A | N/A | DHEA + Testosterone + Mesterolone Mersyndol Forte Diazepam | DHEA + Testosterone + Mesterolone |
iv. investigation to determine whether there was evidence of growth hormone deficiency including measurement prior to treatment of IGF-1 … (for Patient A)
| Patient | Alleged failure to appropriately document reasons for prescription of particular drugs | Alleged failure to record consultation notes when drug(s) prescribed | | A | DHEA | 30 Jan 2019, 24 Jun 2019 and 1 Jul 2019 | | Pregnenolone | 30 Jan 2019 and 1 Jul 2019 | | B | Testosterone | 25 Sep 2019 | | Mesterolone | 5 Jun 2019 | | C | DHEA | 9 Jul 2019 | | Anastrozole | N/A | | Temazepam | 20 Apr 2019 | | D | Somatropin | No consultation notes for prescription of Temazepam on 5 Oct 2018 and 15 Dec 2018 | | Progesterone + DHEA + Triest (recommencement) | | E | Somatropin | On or prior to 11 Apr 2018 | | | No consultation notes when DHEA prescribed on 7 Jun 2017 | | F | | No consultation notes for prescription of DHEA on 11 Jul 2017, 12 Jul 2018, 21 Sep 2018, 9 Feb 2019, 19 Aug 2019 and 18 Mar 2020 | | G | | No consultation notes for prescription of Testosterone + DHEA on 7 Mar 2018, 21 Nov 2018, 27 Nov 2018, 14 Oct 2019 and 10 Mar 2020 | | H | | No consultation notes for prescription of Testosterone + DHEA + Mesterolone on 18 Dec 2017 and 14 Jun 2018 | | I | Anastrozolone | 19 Jun 2018, 8 Aug 2018, 25 Sep 2018, 25 Mar 2019, 14 May 2019 and 11 Jun 2019 | | Pregnenolone | 27 Jun 2018 | | Fluoxetine | 16 Oct 2018, 24 Apr 2019, 25 May 2019 and 3 Sep 2019 | | Mesterolone | 17 Jul 2018 | | Diazepam | 15 Oct 2019, 16 Apr 2019 and 25 Sep 2019 | | | No consultation notes for prescription of DHEA on 5 Mar 2018, 10 Oct 2018 and 9 Jul 2019 | | J | DHEA + Testosterone + Mesterolone | No consultation notes for prescription of DHEA + Testosterone on 19 Dec 2017 | | | No consultation notes for prescription of Diazepam on 15 Aug 2017, 1 Aug 2018, 22 Aug 2018, 11 Sep 201[8], 28 Sep 2018, 2 Jan 2019, 22 Jan 2019, 13 Feb 2019, 14 Feb 2019, 5 Mar 2019, 30 Mar 2019, 26 Apr 2019, 22 May 2019, 5 Jun 2019, 1 Jul 2019, 7 Oct 2019 and 4 Nov 2019 |
i. engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner’s registration, and/or
ii. engaged in more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of the practitioner’s registration.
When two or more of the particulars of Complaint One and two or more of the particulars of Complaint Two are taken together, a finding of professional misconduct is justified.
Following the service of the amended complaint, the appellant sought further particulars by letter dated 9 September 2022 sent under cover of an email dated 12 September 2022. Of present relevance she asked the Commission what was meant by inappropriate dispensing within the meaning of s 139 of the Law (which deals with competence to practise medicine).
In response, by letter dated 21 September 2022, the Commission said:
An added Particular 1 to Complaint One regarding the dispensing of Somatropin directly to the patients. This arose consequent to the objections raised at day one of the hearing and the comments of [the Principal Member]. [The Commission] sought Dr Kertesz’s opinion on this aspect of the evidence. Consequent to the provision of that opinion [the report of 13 August 2022], this particular was added.
| What is meant by inappropriate dispensing | Dispensing the said medication privately and directly to patients, particularly in circumstances where it was prescribed for “off-label” purposes without a clinical, scientific or medical basis. | Dr Kertesz’s first report (tab 40), pages 33 and 34 considered with his answers in his supplementary report …. Professor Carter’s report [dated 16 January 2021], page 7. … |
As a registered medical practitioner, I am permitted to order medication directly from a pharmaceutical supplier and I dispute that is inappropriate conduct. I am permitted to dispense medication, and many practitioners do that in the context of their medical practice by directly providing and administering medication to a patient on site. I purchase various substances for use in my cosmetic practice and use them directly on patients, such as Botox and fillers and anaesthetic cream. That is not an unusual practice.
…
As there was a need for a repeated course of injections, the patients were provided with the medication to self administer. This is consistent with the usual manner in which Somatropin is administered, although not how it is dispensed. I have explained the rationale for ordering the Somatropin myself and that was to do with convenience, for both myself and my patients as ordering from wholesalers is convenient and something I do - and most cosmetic practitioner do - in my cosmetic practice. For Somatropin, it is convenient for patients and it protects their privacy as well, so they do not have to attend a chemist shop and be given growth hormones.
I DISPUTE THAT IT WAS NECESSARY TO ORDER GLUCOSE/INSULIN TESTING TO DETERIMINE GROWTH HORMONE DEFICIENCY PRIOR TO PRESCRIBING FOR THIS PATIENT[.] GROWTH HORMONE DEFICIENCY WAS NOT WHAT WAS BEING TREATED. THE HGH MEDICATIONS WERE BEING USED “OFF LABEL” AND THE PATIENT WAS FULLY INFORMED OF THIS, AND OF THE RISK AND POSSIBLE BENEFITS, AND WAS HAPPY TO HAVE THIS REGIME PRESCRIBED. TO SEND THIS PATIENT FOR SUCH INVESTIGATIVE TESTING WAS NOT INDICATED.
(Capitals in original.)
There are aspects of Dr Kertesz’s report that suggest that there might be some motivation through monetary gain in terms of the dispensing. We say that there is no evidence, that is pure speculation …
Aside from financial considerations, it is difficult to understand why [the appellant] apparently personally dispensed Somatropin rather than arranged for dispensation from a Pharmacy.
The substantive hearing before the Tribunal (constituted by the Principal Member, the Senior Members and the General Member) began on 28 March 2023. It is not necessary to summarise exhaustively what occurred at the hearing except in so far as particular pieces of evidence are relevant to particular grounds. Much of what follows in terms of the Commission’s opening, the appellant’s cross-examination and the written and oral submissions is only relevant to ground 5(a).
The Commission’s opening included the following with respect to the first complaint:
Complaint 1, your Honour and the Members, alleges the practitioner is guilty of unsatisfactory professional conduct because, my paraphrasing of it, the practitioner inappropriately dispensed restricted substances, and that’s complaint 1, particular 1. Now, why is it inappropriate, the Commission says, because it was because of a number of circumstances, the Commission alleges, exists. That is, it was dispensed directly to patients in circumstances where the drug was prescribed by her for off-label purposes without a clinical, scientific or medical basis.
Now, that is not to say that every time someone comes before the Tribunal or is investigated by the HCCC where someone prescribes off-label, and there is an instance of direct dispensing that that is inappropriate. **It’s inviting a circumstantial case, a holistic look at the circumstances that are presented here, where there are numerous patients, and there is a lot of direct dispensing, and in the circumstances it was for off-label purposes. The Commission[‘**s] [submission is] that in the circumstances that this case presented, it circumvented a layer, or oversight, that pharmacies can provide. “Inappropriate” is capture[d] by the circumstances in which it was dispensed. Not because it was just direct, not just because it was off-label, but because of the frequency of it as well.
… In relation to complaint 1, particular 1, I anticipate, and I mean no constraint on the [appellant] in terms of my anticipation, but I anticipate the issue is whether it was inappropriate for there to be this direct dispensing and whether that amounts to unsatisfactory professional conduct.
(Emphasis added.)
Q. You sold somatropin for about $300 per ampule; is that right?
A. Whatever the cost price was on the invoice. Sometimes the price varied. That was dependent on [SciGen].
Q. You charged cost or wholesale price?
A. Yes.
Q. Did you charge for your additional time at all?
A. A consultation. If there was a consultation each time, yes.
Q. You agree you were spending around 29,000 per month on this stock?
A. It’s expensive, unfortunately.
Q. You agree that you were spending around 29,000 on this stock? I can show you invoices.
A. Yeah. On average.
Q. You were spending that money by buying it direct from the wholesaler?
A. Yes.
Q. No doubt you told your clients at the time you were providing it, that you were selling them the product at wholesale or at cost price?
A. Yes.
Q. You accept that that’s an attraction to getting stock direct from you; isn’t it?
MATHUR: I object to that question.
A. No.
…
Q. As a general proposition, would you accept that pharmacists sell medicine?
A. Yes.
Q. Pharmacists sell medicine as a business?
A. Yes.
Q. In order to make money from their business--
A. Mm-hmm.
Q. --they need to sell--
A. Mm-hmm.
Q. --a product marked up from--
A. Mm-hmm.
Q. --the base price.
A. Mm-hmm.
Q. You accept that, as a general proposition?
A. I guess different pharmacists have different pricing. I don’t know how that works, yep.
Q. I suggest to you, you are being evasive in your answers to me right now.
A. No. No, I’m not.
Q. You’re doing that because you don’t wish to accept the proposition that getting stock direct from you was cheaper than it might be getting it from a pharmacy.
A. Are you talking about my script being taken to a pharmacist?
Q. Buying somatropin--
A. Yep.
Q. -from you--
A. Yep.
Q. --Patients A to Patients I--
A. Mm-hmm.
Q. --would’ve been cheaper than buying it from a pharmacy under a script.
A. Okay. I will accept that.
Q. You accept that these patients, not one of them had somatropin purchased through a pharmacy. In other words, all of them were purchased as direct stock from you.
A. Yes.
…
Q. How do you know these patients were not diverting the medicine you directly prescribed?
A. Careful history. I always spend an hour with the patients each time, getting to know them, their character. They were often referred by other patients or doctors. So I knew of their character and honourable character. And blood tests would show repeat IGF-1s went up. They’re just some things that come to mind immediately.
Q. In your answer you said blood tests would show their IGF-1s went up?
A. Yes.
Q. Are you suggesting that there was ongoing monitoring of hormone assessments?
A. Yes.
Q. In relation to each of those patients?
A. I believe so.
Q. You accept as a general proposition, don’t you, that dispensing directly somatropin removes the oversight of the pharmacy as a layer?
A. Yes.
Q. Do you recall … giving an explanation for the direct dispensing was because patients were embarrassed?
A. That was one of the reasons.
…
Q. Wouldn’t that excuse also apply potentially to the dispensing of testosterone to men or women?
A. To some degree, growth hormone seems to have a certain attitude with some pharmacists and they would, unfortunately, put that across to my patients. Also there was a delay because it’s not something that’s on the shelf or they can readily procure, so there was delays in dispensing. It was problematic. It has to be frozen - not frozen, under ice and directly transported by the company and it’s not as a straight forward as a normal medication.
Q. I suggest your explanations in relation to your reason for direct dispensing are not true but you would disagree with that?
A. I do disagree with that.
Q. I suggest the reason that you sought to directly dispense somatropin was to reduce the risk of oversight or investigation about it.
A. No.
Q. You’d agree it’s preferable to encourage dispensing through a pharmacy; wouldn’t you?
A. In general terms, yes.
(Emphasis added.)
The General Member of the Tribunal also directed the appellant’s attention to Dr Kertesz’s report and in particular the author’s reference to “dispens[ing] the Somatropin to patients in lieu of referring Pharmacy prescribing, and she did so outside safety guidelines”.
Dr Newberry, one of the Senior Members, questioned the appellant about the percentage of patients who were prescribed Somatropin. The appellant said that in 2017-2019, the majority of her patients were “cosmetic”. The appellant explained that the time she spent on private practice depended on what shifts she was rostered on by the hospital where she did shift work because she tried to “book around” her hospital shifts. The appellant responded to Dr Newberry’s question whether her patients (including but not limited to those to whom she prescribed Somatropin) had their own general practitioners or whether she was also their general practitioners:
I’d say most of them have or have had a GP. Some are fit and well and they don’t have a GP on the books. They’ll just go to different medical centres. So they don’t have a documented GP. It’s variable.
So is it normal to just decline with age or if you’re someone who says, “I want to be proactive and I don’t want these effects of aging to occur,” this would probably be the realm in which Dr Della Bruna is working and there are people who actively want to prevent the consequences of aging.
There was a quality-of-life measure which, when we first started using growth hormone, you had to complete with the patient. I have to say I did a number of them. I found them singularly useless actually. They just weren’t subtle enough to pick up the shades of grey which is hormone treatment unfortunately. So they would pick up - so they had to score a certain score to actually get growth hormone in addition to all the other hoops they had to jump through initially when you started prescribing growth hormone under PBS criteria. They would repeat the forms and if they felt that it was having a wonderful effect, they just ticked everything as being fantastic and if they felt it really wasn’t doing anything, they just put everything back like they had at a start and I just didn’t find the sensitivity of the scoring was very helpful outside of talking to the person themselves.
(Emphasis added.)
I’d probably have a little bit of alarm bells. Okay, why do you think somatropin’s going to be the solution to your problem and where have you gleaned this information from and why have you come to see me.
Associate Professor Holmes-Walker also said that patients who “come with a self-diagnosis”, “think [HGH] is the solution” and have done internet research also ring “alarm bells”.
The appellant also gave evidence about her patients generally and said that some “came well-informed” about anti-ageing.
[T]he reason I - I feel it was significantly below relates to the use of a drug with potential serious side effects when there are no high quality, large, randomised placebo-controlled trials, and if the only health outcome that is being stated to improve his quality of life, one of my first questions would be: how do we know that’s not a placebo effect, and, therefore, these - these patients are being subjected to a synthetic hormone that has serious potential - potential side effects.
It’s always hard to separate out how much is a placebo effect in any treatment even where there is evidence to show that it should clearly provide benefit and there are plenty of people who will report adverse effects which aren’t even in the listed adverse effects, but they’ll swear that it was the drug that caused it.
As set out above, she had found patients’ self-assessment “quality of life” questionnaires as “singularly useless actually”.
In her written reports, Associate Professor Holmes-Walker said, of present relevance:
For growth hormone treatment to be considered worthwhile in aging one would need to be able demonstrate in trials, improved longevity, organ-specific function, or quality of life.
A limited number of controlled studies suggest that GH supplementation in older men increases lean mass by ~ 2 kg with similar reductions in fat mass of around 2kg, but less evidence that this occurs in women. There is so far little evidence that GH treatment improves muscle strength and performance (e.g. walking speed or ability to climb stairs) or quality of life. The findings reported above are confirmed in this more recent literature review. (Growth Hormone treatment in the aging male, Sattler F. Best Pract Res Clin Endorcinol Metab 2013; 27:541-555). However, there may be individual benefits but collectively in the trial there was no overall benefit.
Under cross-examination and in her written reply, the [appellant] disputed the inappropriateness of direct dispensing of somatropin.
78. The [appellant] gave evidence that she charged wholesale price for the Somatropin but did charge for the consultation.
79. The [appellant] accepted that it would be cheaper for her patients to buy somatropin directly from her rather than from a pharmacy.
80. She was satisfied that her patients were not diverting that medication because she had taken a careful history and a lengthy consultation with each patient.
81. One reason the [appellant] had for direct dispensing of somatropin was because a few of Patients A to I had indicated that they were embarrassed to obtain the medication from a pharmacy.
82. She denied that she directly dispensed somatropin in order to reduce the oversight or risk of investigation about her prescribing somatropin.
83. She said that many of patients A to I came to her well-informed about wellness and hormones.
84. The [appellant] said that in her case, direct dispensing of somatropin was the best way to deal with the situation.
86 … It appears that Dr Kertesz wrongly assumed that the [appellant] was selling the HGH at a markup. There is no evidence that the [appellant] sold somatropin at a marked-up price, so the only fee she attracted was her ordinary consultation fee that would be charged irrespective of whether the somatropin was ultimately prescribed and dispensed by her.
87 The [appellant] on the other hand provided a cogent and credible explanation for the direct dispensing of somatropin to her patients, namely that it was done to minimise their embarrassment, and was unshaken in cross-examination on this credible explanation. The [Commission] has not established that this conduct was significantly below standard, or unethical or improper, even though it might not necessarily be common or usual practice.
…
105 The [appellant] further submits that her conduct could not be said to be unethical or improper within the meaning of ss 139B(1)(a). The direct prescribing of somatropin was not for any undue financial gain and was not prescribed at a markup. To the contrary, the [appellant] charged her patients wholesale price, so she did not profit from selling the product other than her ordinary consultation fee.
…
(Emphasis added.)
115. The contention that the [appellant]’s conduct otherwise constituted improper or unethical conduct has not been established. Specifically, the [appellant]’s direct dispensing of somatropin was at wholesale prices, so the [appellant] did not unduly profit from this mode of prescribing. Her evidence that such prescribing was done to minimise embarrassment to her patients is credible, plausible and uncontradicted.
Inappropriate direct dispensing
16. The [appellant’s] direct “dispensing” of Somatotropin, a restricted substance, to Patients A … circumvented pharmaceutical oversight. On the [appellant]’s evidence, she sold the Somatropin at cost price.
17. The [appellant] gave evidence that her reasons for direct dispensing was because of patient embarrassment. There was no indication in her clinical notes of this and the [appellant] accepts that. The [appellant] accepts that her direct dispensing circumvented pharmaceutical oversight.
18. The direct dispensing at cost price, the Commission submits, must have been an attractive aspect to the [appellant]’s practice. There is a strong available inference when the Tribunal considers the number of patients, and the various areas from where they live, that this aspect of the [appellant]’s practice encouraged return customers (for price and/or for convenience).
19. The [appellant] spent around $29,000 per month purchasing the product direct from the wholesaler, SciGen. There is an available inference that for the [appellant] to have spent that much per month, she saw benefit in this aspect to her practice.
20. This would have affected her objectivity and judgment when determining whether it was clinically appropriate for her patient. The regularity of the prescription supports this submission [details given of regularity].
- There is an available inference on the evidence (the fact of regular prescription, frequency of it and the direct dispensing) that the [appellant] lacked objectivity with respect to prescribing Somatotropin to her patients. Her direct dispensing of it was evidently profitable enough for her to buy the product at such expense and it must have been that profitable to her practice in terms of repeat customer.
22. Direct dispensing must have been attractive to the patient too – at cost price, it saved time, and it was convenient. The upshot is that patients know they can see her and obtain the medication knowing they do not have to go to the Pharmacy for it.
23. There is also the risk of diversion with direct dispensing. The [appellant] told the Medical Council she knew patients were not diverting because of monitoring them but there is no evidence to suggest this was in fact done.
24. The [appellant] stated in her written evidence that patients came to her informed about hormone substances in the wellness sphere and only prescribed on that basis. However, when cross-examined on this point, the [appellant] said her understanding of how her patients were “informed” was that the [appellant] asked her patients to explain back to her what she had told them. It follows that the patient is significantly guided by the [appellant] with respect to the benefits and risks of the product in the wellness sphere. There is a concern about her lack of objectivity in that “information” if the [appellant] is investing the amount of money that she paid for Somatotropin and directly dispensing it.
25. The Commission submits the evidence shows to the required standard that the [appellant] gained from this practice of direct dispensing – in reputation – which increased patronage – which is good business. The [appellant] lacked objectivity with respect to the medication. This was not just inappropriate but in the circumstance in which it was prescribed, bearing in mind the medication was prescribed outside of accepted therapeutic standards, the conduct amounted to UPC [unsatisfactory professional conduct] and professional misconduct.
The Tribunal heard the parties’ submissions on 27 March 2024. In its oral submissions, the Commission referred to the issue of direct dispensing and submitted that this “removes pharmaceutical oversight and arguably invites a lack of objective approach to [Somatropin].”
The Commission also submitted:
An enormous cost was spent by the [appellant] to purchase somatropin that she directly dispensed. The [appellant] gave evidence about the patients being embarrassed. … [t]his is an unreliable explanation … the more reliable explanation is that prescribing somatropin was an embedded part of her practice: it was what she was known for.
The Commission submits that on the whole of the evidence …, given the nature of the [appellant’s practice], the [appellant] lacked objectivity, and this improperly influenced her favouring of these products, and lack of consideration of alternatives.
Ms Mathur responded to the Commission’s submissions on the first particular of the first complaint (inappropriate dispensing). She identified the issue as one that “loom[ed] large” in the Commission’s submissions and its “assertion that it significantly impacted the [appellant’s] objectivity.”
In response to the submission (based on SciGen’s documents) that the appellant had, between June 2018 and June 2019 spent in the order of $348,000 ($29,000 per month) on Somatropin, Ms Mathur calculated, by reference to the evidence, including the appellant’s, that this amount equated to 36 patients spending $8,580 each in that year on 52 carts (a cart being a week’s supply of Somatropin), with each cart costing in the order of $165, or $200, depending on whether the patient bought it in bulk. This calculation could be performed as every patient received the same dose of Somatropin. Ms Mathur also confirmed that the Commission identified 33 patients in total who were identified as having been prescribed Somatropin, of whom the Commission selected 10 to base its complaints. Ms Mathur relied on the appellant’s oral evidence (for which there was no other source in the evidence) that she dispensed and prescribed Somatropin to about 20% of her patients.
In response to the Commission’s submission that the appellant was known for prescribing Somatropin and received referrals on this basis, Ms Mathur submitted that, as there was no evidence from any patient, there was no evidence to support that proposition.
The grounds of appeal are numerous and several paragraphs of the Tribunal’s reasons are the subject of more than one ground. For this reason, I propose to set out below the principal paragraphs which the appellant submitted give rise to questions of law as alleged in grounds 1-6 and or a question of fact in ground 7. For ease of reference, I propose, subject to the following, to set out these paragraphs in numerical order.
It is apparent from the structure of the reasons that the Principal Member wrote his reasons first and that the majority reasons are responsive to those reasons. Thus, the Tribunal’s reasons contain references to the paragraph numbers of the Principal Member’s reasons, in part to indicate its disagreement with him. As the Principal Member’s reasons do not constitute the reasons of the Tribunal (s 57 of the NCAT Act), I propose to refer to them only where it is necessary to do so to understand the reasons of the Tribunal and to insert them where they fit in the order in which the Tribunal has expressed its reasons.
269 We note section 3A Objective and Guiding Principle of [the Law]:
“In the exercise of functions under a NSW provision, the protection of the health and safety of the public must be the paramount consideration.”
270 In addition, we note that the Tribunal is bound by the [NCAT Act]. Section 38 (2) of the [N]CAT Act [set out].
271 When considering “the paramount consideration” of the [Law] together with [s] 38 (2) of the [N]CAT Act, it is plausible that the manner in which a Tribunal under the [Law] may conduct itself may be different to that of other jurisdictions. Accordingly, any judgement that may have been provided in another jurisdiction, may have limited transferability or not be transferable in relation to considerations under [the Law].
272 In respect of the Tribunal members, there is a great deal of experience that each member brings to the Tribunal. For example, the general practitioner member brings a great deal of practical insight into the policies, procedures and practice of general practitioners. The endocrinologist member similarly brings great experience and knowledge of the use of medicines such as growth hormone.
273 We contend that the “paramount consideration” of the [Law] influences the factors to be taken into account by the Tribunal, in that the protection of the health and safety of the public becomes its primary function.
In regard to the extensive redaction of the PRU’s report within the Health Care Complaints Commission’s (HCCC) brief of evidence, we are highly critical of the HCCC’s decision to allow the substantial redaction (some 99% of the report) which effectively left some two lines of text per page available to the Tribunal from the originating complaint. Given the PRU’s extensive experience regulating the Poisons and Therapeutic Goods Act 1966 it would have been instructive for the Tribunal to have had the PRU’s expertise and comments within their report. If there were any concerns raised in the PRU’s report that may have been additional to the particulars of this complaint, it would have been within the ability of this Tribunal to disregard those concerns that were not on point. As this was the originating complaint, the Tribunal should have had access to the PRU’s reasoning concerning the prescribing of HGH, not only their one sentence conclusion.
No complaints from patients
280 In reference to paragraph 111, his Honour notes:
“... none of the ten patients whose prescribing gave rise to the Commission’s application has made any complaint about any aspect of their treatment by the Practitioner.”
281 However, this Tribunal’s paramount consideration is the protection of the health and safety of the public and not to monitor or ensure patient satisfaction. In this case our paramount concern in the protection of the health and safety of the public is the potential for harm from very serious side effects caused by the prescribing of growth hormones (variously referred to as somatotropin, growth hormone and HGH throughout the decision) without adequate serological monitoring for side effects.
283 Under the Pharmaceutical Benefits Scheme (PBS), treatment with growth hormone is indicated for specific conditions. In addition, the prescription must be provided by a medical practitioner in consultation with a nominated specialist and only after obtaining an authority to prescribe from the PBS. However, these controls do not apply if the medical practitioner prescribes “off label”. The Australian Register for Therapeutics Goods (ARTG) has the following indications for SciTropin A:
“Growth hormone is intended for the long term treatment of children (above three years of age) with:
• growth disturbance due to insufficient secretion of pituitary growth hormone
• growth disturbance associated with gonadal dysgenesis (Turner syndrome)
• growth disturbance associated with chronic renal insufficiency.”
284 For a medicine to be listed on the ARTG, it undergoes a rigorous evaluation process by the Therapeutic Goods Administration (TGA) to ensure its safety, its quality, and efficacy for use in Australia. When a medication is used “off label”, there is limited data on safety, quality and efficacy. Given the practitioner is providing growth hormone directly to patients, without a prescription being dispensed through a pharmacist, off PBS and off label, she is circumventing all safety measures, compromising and endangering public safety.
In the following, the Tribunal accepts the expert evidence of all three expert witnesses. For the evidence of each expert witness, the Tribunal has undertaken an evaluative process in order to determine the benchmark standard which would be expected of a general practitioner who is prescribing HGH medications “off-label” to patients in the context of anti-ageing and/or wellness.
290 In relation to paragraph 39 [of the Principal Member’s reasons], we accept that Professor Carter is a highly qualified endocrinologist and not a general practitioner. However, we note that the on-label prescribing of HGH medications is solely the province of endocrinologists and not that of general practitioners. For this reason, we accept both Professor Carter and Professor Holmes-Walker’s opinions concerning the steps required of a medical practitioner prior to prescribing HGHs; and, the ongoing monitoring of patients during treatment.
291 In relation to paragraph 41 [of the Principal Member’s reasons], we accept that Professor Carter has never practised in “cosmetic medicine” or in “anti-ageing medicine”. We are satisfied that Professor Carter has a substantial understanding of the side effects of either off-label or on-label prescribing of HGHs. Prescribing off-label would occasion the same side effects as prescribing on-label. We note that Professor Carter has provided evidence as to the side effects, the patient assessment required, examination and cautions associated with prescribing HGHs. If a medical practitioner, who is not an endocrinologist, wishes to prescribe HGHs off-label, then it follows that they should undertake the same assessments, examination, cautions and understand the potential for harm to the patients, as stated by Professor Carter. In view of the side effects of prescribing HGHs, any medical practitioner who decided to prescribe off-label HGHs would need to apply the same rigor as an endocrinologist in order to protect the health and safety of the patient.
292 We are not critical of Professor Carter’s evidence on the basis that he does not prescribe HGHs for the same purposes as the practitioner. The views in this section are not limited to the paragraphs listed above but apply to his Honour’s decision as a whole. (e.g. paragraphs 185, 186, 187 and 188 [of the Principal Member’s reasons])
(Emphasis added to indicate the alleged error.)
296 With regard to the identification of side effects, we note the report dated 23 May 2022, where Professor Carter outlined the medical conditions which are exacerbated by excess growth hormone, such as somatropin, which include:
“heart disease (and particularly cardiomyopathy), diabetes mellitus, hypertension, arthritis, sleep apnoea and hypothyroidism. There are clinical concerns that occult carcinomas have an increased growth potential when exposed to excess GH; and people with acromegaly are known to have an increased incidence of carcinomas.”
297 We note that the practitioner has not undertaken IGF1 blood tests to determine if any of the ten patients had an excessive of growth hormone, which would be germane to the protection of the health and safety of these patients. From the patient records contained in the HCCC brief of evidence, there is no evidence that any of the ten patients were human growth hormone deficient. The practitioner gave evidence that some of her patients were experiencing “fatigue or brain fog”. Fatigue and brain fog are not the key indications for human growth efficiencies.
…
328 The Tribunal note the Commission’s submission dated 19 March 2024 which stated that the treatment periods for each of the ten patients ranged from 9 months to 28 months, where the average treatment period was just under 18 months. We note that in the ten patient records produced in relation to this matter, the practitioner has not sought blood tests to measure the IGF1 for any of the patients. In these circumstances, continuing to prescribe HGHs to these patients, without the appropriate serological monitoring amounts to serious negligence. This view is not limited to paragraph 198 and applies to his Honour’s decision as a whole.
(Emphasis added.)
Failure to monitor the patients
300 In relation to the ongoing monitoring of the ten patients in this case, in his report dated 23 May 2022 Professor Carter stated:
“Her indications for the prescribing of the GH should’ve been clearly documented in the notes and the potential side-effects of the medication should also have been outlined to the patient and documented in the notes. Prior to prescribing somatropin, a history and examination relevant to conditions such as heart disease, glucose intolerance, hypertension, sleep apnoea & carpal tunnel syndrome along with history relating to family history, past history, or current history of cancer that should’ve been undertaken. During the course of treatment with Somatropin, examination regarding these conditions should have been undertaken and documented in the clinical notes, in addition to whether or not the reason for Somatropin injections had been justified on the basis of the clinical response.”
301 As this information was largely missing from the patient records, it can be said that the practitioner did not undertake initial or subsequent assessment relevant to the side effects listed by Professor Carter with respect to the ten patients in this case.
302 In relation to paragraph 52, we note that after reviewing the full medical record, Professor Carter in his third report dated 12 July 2022 confirmed that “many of the histories and documentation of many of the examinations was quite reasonable”.
(Emphasis in original.)
It was not disputed that, approximately every month when she was prescribing Somatropin, the appellant purchased in the order of $29,000 of the drug, which she kept in a freezer in her rooms, and dispensed directly at cost to patients who, accordingly, were relieved of the need to present a prescription at a pharmacy because their prescriptions for Somatropin could be filled by the appellant at the time of consultation.
The Tribunal found, with respect to the appellant’s direct dispensing of Somatropin that it had the effect of circumventing the oversight and surveillance which the involvement of a pharmacist brings ([284] and [346]). With respect to the financial aspect of direct dispensing, the Tribunal said:
Financial incentives
313 In relation to paragraph 65, 111 and 169 [of the Principal Member’s reasons], the practitioner was spending around $25,000 per month on somatropin (see paragraph 176 [of the Principal Member’s reasons]) and it is plausible that this expensive level of ongoing inventory may have impacted her objectivity as it would have generated considerable pressure on the practitioner to maintain the turnover of her stock of somatropin.
314 Prescribing and dispensing a restricted substance at cost would be a substantial financial incentive for many patients to consult with the practitioner, thereby raising the number of patients attending her consultations. This view is contrary to the view expressed by [the Principal Member] at paragraph 169 [of the Principal Member’s reasons]. There were no receipts issued by the practitioner in evidence and we had to rely on oral evidence from the practitioner in regard to the costs of consultations and prescriptions issued by her.
331 We acknowledge Professor Holmes-Walker’s understanding of: evidence-based treatments for hormone deficiency, the requirements to clinically assess and manage patients and the need to maintain medical records that comply with regulatory standards. During oral evidence, Professor Holmes-Walker stated that in the past she had prescribed “off label” HGH for patients with serologically identified partial human growth deficiencies. However, unlike the practitioner, Professor Holmes-Walker prescribed an individualised starting dose based on the patient’s weight, titration of growth hormone over several weeks based on safety, efficacy and tolerability. In addition, Professor Holmes-Walker conducted ongoing monitoring at least six months with IGF-1, lipids, glucose, blood pressure, weight and body mass index. All of these considerations are missing from the practitioner’s patient records.
332 In Professor Holmes-Walker’s report, she states that more clinical trials are needed before growth hormone treatment is considered to be worthwhile in the treatment of ageing.
333 Professor Holmes-Walker is vigilant in relation to the monitoring of her patients and limits her treatment to six months where there is no clinical response to the treatment. Despite her considerable experience and knowledge, Professor Holmes-Walker has not prescribed pregnenolone or mesterolone, whereas the practitioner has prescribed these restricted substances to some five patients.
334 In relation to paragraph 192 and 193 [of the Principal Member’s reasons] we note that Professor Holmes-Walker stated that in her view the practitioner’s conduct fell below the required standard but not significantly below. The Tribunal acknowledges and accepts the evidence provided by Professor Holmes-Walker as to the management of patients who are prescribed HGH.
335 However, the Tribunal is concerned that Professor Holmes-Walker’s assessment of the conduct of the practitioner is based on her level of understanding as a senior endocrinologist who is experienced and knowledgeable in the area of human growth deficiencies. As stated above, despite Professor Holmes-Walker extensive experience and training, she prescribes HGH to significantly fewer patients than the practitioner and has never prescribed pregnenolone or mesterolone. Prescribing HGH for an endocrinologist may fall within or below the required standard as an endocrinologist has a greater degree of understanding concerning the prescribing and management of patients on HGHs. However, on this point we prefer the evidence of Dr Kertesz who, as a general practitioner, understands the experience and training that a general practitioner may rely upon. Dr Kertesz acknowledged the limitations of general practice training in area such as growth hormones. This view is not limited to paragraph 180 [of the Principal Member’s reasons] and applies to his Honour’s decision as a whole.
Anti-aging area of medicine
336 In regard to paragraphs 111 and 112, practising in the “anti-ageing area of medicine” needs to be carefully measured, for the obvious reason that patients often sense that their bodies are ageing and may be keen to seek anti-ageing medications which offer the “fountain of youth”. For these reasons, such patients may have a strong predilection for anti-ageing medications, despite the poor effectiveness of the medication. While the practitioner stated that she had refused to prescribe somatropin to some patients, there was no evidence provided to the Tribunal that indicated that this may have been done.
337 During the course of the hearing a number of the experts referred to the “placebo effect” associated with growth hormones which is a significant concern especially in the anti-ageing area of medicine where patients are prescribed HGHs. Given that much of the effectiveness of HGH on ageing is anecdotal, it is possible that the anecdotal effects of HGH correspond to a placebo effect. This view is not limited to the paragraphs listed here (e.g. 111 and 112) but applies to his Honour’s decision as a whole.
111 As noted earlier, none of the ten patients whose prescribing gave rise to the Commission’s application has made any complaint about any aspect of their treatment by the Practitioner. There is no rational basis for disputing the Practitioner’s statement with respect to patients’ reports with respect to their quality or enjoyment of life. To the extent that it has been suggested, albeit not as part of a particular of any complaint against her, that the Practitioner has in some way financially benefitted from directly dispensing medication to her patients, the evidence does not establish that any such prescribing has been unlawful or intended to have, or have had, any actual or likely financial benefits for the Practitioner, or any inappropriate financial benefits for her patients.
112 The Practitioner reiterated that her patients are “intelligent, fully informed and very aware of what is available in the anti-ageing area of medicine. They are fully consented to any medication regime I recommend or administer, whether on-[label] or off-label”. There is no evidence to the contrary, or, in my view, any reason to reject the Practitioner’s assertions.
342 In relation to paragraph 116, his Honour stated that the practitioner: “was able to explain why she had prescribed particular medications, and the dosages which she had prescribed.**” However, the patient records did not contain any of the information that the practitioner provided in oral evidence during the hearing.
343 The Medical Board Good medical practice: a code of conduct for doctors in Australia at section 10.5 states that it is essential for the continuing good care of patients to keep accurate up-to-date and legible records that report relevant details of clinical history, clinical findings, investigations, diagnosis, information given to patients, medications, referral and another management of the patient in the form that can be understood by other health practitioners. This is consistent with the opinion of Dr Kertesz.
344 The evidence of what occurred or what was undertaken at the time of the consultation is contained in the patient record. Oral evidence pertaining to specific consultations, some three or four years later, cannot replace a patient record which has been contemporaneously recorded and accordingly we reject the practitioner’s oral evidence on these points. If it is not in the patient record then the actions, justifications and monitoring did not occur despite the practitioner’s ex post facto assertions. This view is not limited to the paragraphs listed here but applies to his Honour’s decision as a whole. (e.g. paragraph 209, 235, 240)
Red flags
350 Paragraph 135 contained a dialogue between one of the professional members and the practitioner concerning patients who asked for particular restricted substances and whether this behaviour raised a “red flag” when the patient’s address was in Queensland or in western Sydney. In her response the practitioner stated that she was “comfortable” that the patients were not drug seeking. At paragraph 171 [of the Principal Member’s reasons] his Honour stated:
“The fact that patients from places far from her surgery sought out the Practitioner does not establish or imply that there was anything untoward about her method of practising. Many professional people, including lawyers, are approached by clients from far distant places because they are known or believed to be good at what they do.”
And,
“Inherent in the Commission’s submission is that the Practitioner was “known” to prescribe the drugs referred to in the Complaint in circumstances where a responsible practitioner would not have done so.”
351 While professionals including lawyers may be approached by persons because they are known to be good at their profession, if a patient approaches a medical practitioner with a request for a particular drug, this behaviour raises a “red flag” as it may indicate “drug seeking behaviour’’ especially in the field of general practice about which no speciality is held out. In addition, where the patient’s residential address is substantially out of the general area of the practice, such as western Sydney or in Queensland, then this would raise additional concerns or red flags. Significantly, Professor Holmes-Walker refers to this type of drug seeking behaviour in the excerpt in paragraph 101 when she says:
“Anyone who comes with a self-diagnosis, that’s an alarm bell, I have to tell you. It’s not just, you know, I think growth hormone is the solution. There’s lots of alarm bells when you’re an endocrinologist.”
352 It is evident from her remarks in paragraph 135 that the practitioner did not chose to consider these characteristics of her patients. The practitioner’s attitude in relation to red flags suggested an indifference to this risk factor which may impact on the health and safety of the patients. This view is not limited to the paragraphs listed here but applies to his Honour’s decision as a whole (e.g. paragraph 207, 208 [of the Principal Member’s reasons]).
353 In our evaluative process, acquiescing to drug seeking behaviour has the potential to harm the health and safety of the public.
The Tribunal said, at [354], that it was “comfortably satisfied that the practitioner’s prescribing and management of the off-label medications to the ten patients referred to in the [Commission]’s application fell significantly below the requisite standard.”
The reference to comfortable satisfaction can be taken to be a reference to Briginshaw v Briginshaw (1938) 60 CLR 336; [1938] HCA 34 (Briginshaw), which was expressly referred to by the Principal Member who said at [161]:
The Tribunal must be comfortably satisfied that the evidence establishes each of the allegations made by the Commission (Briginshaw v Briginshaw (1938) 60 CLR 336 [1938] HCA 34; Re Anderson and the Medical Practitioners Act 1967 85 WN (NSW) 558).”
255 In assessing the significance of the Practitioner’s admitted or proven departure from the required standard of knowledge, skill, judgement or care exercised in the prescribing and management of off label medications, it is relevant to have regard to the following findings, none of which, in isolation, is determinative of the critical issue:
(i) no patient of the Practitioner has complained about her treatment of him or her;
(ii) there was no evidence that any patient has suffered any adverse or seriously adverse consequence of the Practitioner’s prescribing or management of off-label medications for them;
(iii) no expert has suggested that, irrespective of the absence of such evidence, anything relating to the Practitioner’s prescribing and management of off-label prescriptions for her patients would have been expected to have produced adverse health consequences for any of the ten patients in this case;
(iv) having seen all of the Practitioner’s admittedly inadequate clinical records, Professor Carter made significant concessions about the adequacy of the Practitioner’s prescribing and management of off label medications for her patients;
(v) after the Commission’s experts had seen the Practitioner’s clinical records, its application was significantly amended by deleting significant particulars of the Complaint. Comparing what was originally alleged against the Practitioner with what was ultimately alleged, and inferring that, responsibly, the Commission abandoned those particulars because it was satisfied that doing so was appropriate, it can be seen that significant aspects of the Practitioner’s prescribing and management of off label medications was conceded to not have fallen below the required standard;
(vi) the Practitioner gave detailed evidence in cross-examination by Counsel for the Commission and, significantly, in response to probing questions by the Tribunal, particularly by the two Medical Members of the Tribunal. Although in cross-examination Counsel for the Commission disputed that the Practitioner had done certain of the things which she claimed she had, there is in my view no reason to reject the Practitioner’s claims with respect to what she did in the course of prescribing or managing off-label medications for the ten patients the subject of these proceedings;
(vii) the evidence does not establish that the “cohort” of patients of the Practitioner whose treatment gave rise to the present proceedings was disproportionate to the number of anti-ageing or wellness patients who the Practitioner saw over the period covered by the treatment of the ten patients;
(viii) the Pharmaceutical Regulatory Unit, whose audit of the Practitioner’s prescribing apparently caused or influenced the present proceedings, took no action against the Practitioner and no officer of the PRU gave evidence in these proceedings in support of the Commission’s case;
(ix) the claim that there was anything sinister associated with the Practitioner’s prescribing or direct dispensing of off-label medication has not been established to my comfortable satisfaction, either with respect to the practice itself or any asserted financial implications of it. The Commission has not in my view proved that the Practitioner attempted to “veil” any inappropriate conduct with respect to prescribing or dispensing off-label medication;
(x) during the course of their questioning of the Practitioner, although expressing reservations about the Practitioner’s responses to such questions, in my view, the Practitioner was not confronted with documentary or other evidence contradicting what she said about her prescribing and monitoring of off-label medication for the patients in this case;
(xi) the evidence does not in my view establish that, whatever the shortcomings in her prescribing and management of off label medications, the Practitioner’s objectivity or judgement was compromised by financial or any other considerations;
(xii) the evidence does not in my view establish that any of the Practitioner’s patients did not give informed consent to the prescribing of off-label medications, or did not have the maturity to make such a decision, or the opportunity to reflect on the consent form which the Practitioner gave each of them before doing so.
256 Accepting that, as an evaluative determination, minds can reasonably differ, and that there is a point at which meaningful revelation of the process of reasoning of a decision maker becomes artificial, for the reasons recorded above, I am not comfortably satisfied that the Practitioner’s conduct fell significantly below the standard required of her.
355 In relation to paragraph 255 and his Honour’s findings, the following responds to his Honour’s subparagraphs as follows:
(i) while there were no patient complaints there was a mandatory notification from the PRU to the Medical Council which resulted in conditions on the practitioner’s registration prohibiting the prescribing of HGHs;
(ii) and (iii) Professor Carter identified side effects in patients B and C that he attributed to excess growth hormone. Professor Carter’s evidence was that there was potential for significant side effects in the prescribing of HGHs. Considering the prolonged treatment periods that averaged over 17 months for the ten patients, any potential side effects would have gone unmonitored because of the absence of IGF1 serological analysis;
(iv) The Tribunal accepts the Medical Board Code of Conduct and specifically paragraph 10.5 of that document which requires that contemporaneous complete and accurate medical or patient records be maintained. Oral evidence, some four years after a consultation with a patient, from the practitioner pertaining to specific consultations in lieu of entries in the patient record are rejected by the Tribunal;
(v) The Tribunal decision refers to the Amended Complaint filed on 16 August 2022 and does not include any previous allegations made against the practitioner.
(vi) The Tribunal rejects the practitioner’s oral evidence in relation to her prescribing and management of the ten patients who were the subject of the complaint. Patient records are required to be made contemporaneously and in accordance with 10.5 of the Code of Conduct. Ex post facto assertions in respect of patient consultations that occurred some four years prior are inherently unreliable.
(vii) Unknown and not the subject of the particulars;
(viii) Disagree, see comment for (i) above;
(ix) “Sinister’’ or “veil” were terms that were not included in the particulars and hence not relevant to these proceedings;
(x) It is not the Tribunal members’ role to be confronting or to contradict the practitioner. The Tribunal members have undertaken an evaluative process focusing on the evidence of the practitioner and all three expert witnesses, as evidenced by the above reasons. The Tribunal has carefully considered the benchmark standard for this practitioner and has assessed her conduct against that standard;
(xi) Disagreed. The practitioner paid for and stored some $25,000 of Somatropin per month which she dispensed directly to patients. Paying for and storing such a valuable inventory would have been reason to prescribe and create turnover of this inventory thereby influencing her objectivity in prescribing;
(xii) Agreed, with reservations as set out in the reasons under “anti-ageing area of medicine” and the quest for the “fountain of youth”.
Disciplinary proceedings, such as the proceedings in the Tribunal, are not criminal proceedings. They have been described as sui generis: Weaver v The Law Society of NSW (1979) 142 CLR 201 at 207; [1979] HCA 35. Their purpose is the protection of the public, although it has been recognised that, from the perspective of a practitioner, they may have consequences which appear to be penal: Rich v Australian Securities and Investments Commission (2004) 220 CLR 129; [2004] HCA 42 at [30]-[35] (Gleeson CJ, Gummow, Hayne, Callinan and Heydon JJ).
There are various ways in which a complaint can come before a Tribunal. In the present case, as referred to above, the PRU made a mandatory notification to the Medical Council as a result of the appellant’s prescribing Somatropin. The definition of “notifiable conduct” in s 140 includes “(d) placing the public at risk of harm by practising the profession in a way that constitutes a significant departure from accepted professional standards.” Various persons, including, it would appear, the PRU, have an obligation under Division 2 of Part 8 of the Law to inform, in this case, the Medical Council, if they form a reasonable belief that a medical practitioner (referred to as a registered health practitioner) has behaved in a way that constitutes notifiable conduct. Subdivision 2 of Division 3 of Part 8 of the Act deals with the making of complaints. Section 144B provides that any person can make a complaint and that a complaint may also be made by the Council (in this case, the Medical Council). Pursuant to s 145C, the Commission may refer a complaint to the Tribunal, after consultation with the Council. This appears to be what occurred in the present case.
Section 38(2) of the NCAT Act provides that “[t]he Tribunal is not bound by the rules of evidence and may inquire into and inform itself on any matter in such manner as it thinks fit, subject to the rules of natural justice.” Although the Tribunal is not bound by the rules of evidence, it has been accepted that in order to uphold the complaints, the Tribunal must be “comfortably satisfied” that the alleged conduct actually occurred: Gautam v Health Care Complaints Commission [2021] NSWCA 85 (Gautam) at [85]-[87] (Payne JA, Leeming JA and Simpson AJA agreeing). Where a court, and not the Tribunal, makes a finding in a disciplinary proceedings, it tends to be expressed in terms of s 140 of the Evidence Act 1995 (NSW), or that it is “on the balance of probabilities”, having regard to the principles in Briginshaw: see, for example, Kumar v Legal Services Commissioner [2015] NSWCA 161 at [60] (Leeming JA, Basten JA and Sackville AJA agreeing). Because of the wording of s 38(2) of the NCAT Act, tribunals do not necessarily refer to legal authorities or provisions of the Evidence Act, but may, as the Tribunal did in the present case, put the matter in terms of “comfortable satisfaction”, to indicate that the decision-maker appreciates that, when a grave allegation is made, they ought reach a state of comfortable satisfaction before finding that it has been made out.
Section 165B(1) of the Law relevantly provides that if a complaint is referred to the Tribunal, the Tribunal must inform the Council for the health professional of the referral and the Council for the health profession must select three persons to sit as members of the Tribunal in the proceedings. Where the complaint is in respect of a medical practitioner, the Tribunal is to be constituted by a Divisional member who is a judge of the Supreme Court or the District Court; two health practitioners who are registered in the same health profession as the person who is the subject of the inquiry; and a lay person (not a health professional): ss 165 and 165B(2).
Section 165M requires the Tribunal to give a written statement of the decision which must set out findings on material questions of fact, refer to any evidence or other material on which the findings were based and give the reasons for the decision. These reasons are to be provided to the parties and the relevant Council (in this case, the Medical Council) and may be published: s 165M(1) and (4).
As referred to above, the members who constitute the Tribunal may be divided in opinion, in which case the opinion of the majority is taken to be the opinion of the Tribunal: s 57 of the NCAT Act.
It follows that the Law and the NCAT Act expressly contemplate that the reasons for the Tribunal’s decision will be expressed by non-lawyers (since three out of four Tribunal members will be non-lawyers and the scenario which eventuated, that the Judicial Member is in the minority, is envisaged): see Bisley Investment Corporation Ltd v Australian Broadcasting Tribunal (1982) 59 FLR 132 at 157 (Sheppard J).
The approach required to be taken by this Court was summarised in Minister for Immigration and Ethnic Affairs v Liang (1996) 185 CLR 259 (Liang) at 272 (Brennan CJ, Toohey, McHugh and Gummow JJ); [1996] HCA 6, referring to the decisions of the Full Court of the Federal Court in Collector of Customs v Pozzolanic Enterprises Pty Ltd (1993) 43 FCR 280 and McAuliffe v Secretary, Department of Social Security (1992) 28 ALD 609 at 616 (Spender, Foster and O’Loughlin JJ), as follows:
[A] court should not be “concerned with looseness in the language … nor with unhappy phrasing” of the reasons of an administrative decision-maker. The Court continued: “The reasons for the decision under review are not to be construed minutely and finely with an eye keenly attuned to the perception of error.”
These propositions are well settled. They recognise the reality that the reasons of an administrative decision-maker are meant to inform and not to be scrutinised upon over-zealous judicial review by seeking to discern whether some inadequacy may be gleaned from the way in which the reasons are expressed.
(Footnotes omitted.)
The submissions advanced by Ms Mathur in support of this ground went considerably beyond the ground as expressed. However, as Ms Heger SC, who appeared with Ms New and Mr Beshara on behalf of the Commission, addressed the submissions as put, it is not necessary to confine Ms Mathur to the terms of the ground.
In substance, Ms Mathur submitted that the Commission’s case, in so far as it was based on an allegation that the appellant’s clinical judgment may have been compromised by financial reasons, had not been properly particularised. She submitted that the failure on the part of the Commission to particularise this aspect of its complaints had the consequence that the appellant did not address this matter in her evidence. Further, she submitted that counsel for the Commission in the Tribunal did not squarely put the matter to the appellant in cross-examination and therefore the appellant was deprived of an opportunity to answer it and, thus, was denied procedural fairness.
Ms Mathur accepted that she had not detected the denial of procedural fairness in the course of the proceedings before the Tribunal and had, therefore, not objected to the Commission’s submissions concerning financial considerations. However, I understood her to submit that any failure on her part ought not be visited on the appellant, who was relevantly denied procedural fairness.
The findings of the Tribunal which are relevant to ground 5(a) are set out above. The ground turns on whether there was a denial of procedural fairness.
The Commission’s case on inappropriate dispensing of Somatropin was, in substance, that the appellant adopted a business model which did not involve proper individualised patient care, having regard to the risk of serious side effects posed by Somatropin and that the business model compromised her professional judgment. As the Tribunal observed in its finding at [314] (extracted above), there were no receipts issued by appellant in evidence and the Tribunal had to rely on the appellant’s oral evidence as to the cost of consultations, prescriptions and (by inference) the medication she dispensed to them.
Professor Carter’s opinion, following the rejection of the wording referring to financial considerations, was that it was difficult to understand why the appellant personally dispensed Somatropin herself rather than have the prescriptions she gave to her patients filled by a pharmacy. The Commission’s hypothesis as to the reasons for direct dispensing were: the appellant wanted to avoid the oversight (of her and her patients) which would inevitably come from a pharmacy; and there was a financial benefit to her in direct dispensing since she came to be known for it and, therefore, it increased the number of patients who would come to her for consultations to obtain Somatropin, which other practitioners might not be as willing to prescribe off-label and directly dispense as the appellant.
The appellant should have been permitted to give sworn evidence as to why she was not motivated by financial gain or why her objectivity in prescribing was not compromised as a result of feeling any pressure by the stock that was kept on site. It was her ability to answer a fairly, we say, serious allegation against her.
I consider that the Commission’s particulars were sufficient to raise financial considerations as a motive which affected the appellant’s practice of directly dispensing Somatropin. In its provision of further particulars on 21 September 2022, the Commission spelled out the connection with the preliminary hearing on 30 May 2022 (and, by necessary implication, the admonition by the Principal Member that financial motive would need to be particularised) and Professor Carter’s opinion that, in effect, there was no professionally appropriate reason for the appellant to dispense Somatropin directly to her patients. Although Professor Carter’s opinion (that, professionally appropriate reasons being absent, the appellant’s reason must be, by process of elimination, financial) was subsequently rejected as falling outside the parameters of an expert opinion, his opinion was incorporated into the Commission’s particulars. Although this method was not ideal, it was sufficient to put the appellant on notice of the way in which the Commission put its reliance on financial considerations to fulfil the requirements of procedural fairness.
The financial motive having been raised, the appellant was on notice that her business model was relevant to the allegation of inappropriate dispensing. She gave evidence, for example, that she supplied Somatropin at cost, and ultimately accepted that this was beneficial to her patients, none of whom obtained Somatropin from a pharmacy, because she could supply it more cheaply to them than a pharmacist could (because the pharmacist would need to build in a profit margin). In the course of her evidence, as set out above, she was asked about the percentage of her patients who were prescribed with Somatropin and gave evidence about how many standard doses (“carts”) she would dispense. Further, the evidence established that she purchased about $29,000 worth of Somatropin per month for the June 2018-June 2019 year and therefore, necessarily, bore the holding costs of such stock before it was dispensed at cost to her patients.
It follows from Ms Mathur’s concession that there was no denial of procedural fairness in the Tribunal’s finding that the appellant’s business model gave her patients a financial motive to consult her because they knew that she directly dispensed Somatropin at cost, that the Tribunal was permitted to find, as it did, that the appellant had a corresponding financial motive. The appellant was on the other side of the transaction: any financial benefit to the patient from the provision of her services necessarily gave her a competitive advantage and was, therefore, to her own financial benefit. Unlike a pharmacy, which solely dispenses drugs (and therefore, as a matter of financial imperative, charges a margin for profit on top of the cost price), the appellant was providing a composite service which involved dispensing, prescribing and consulting, which she could bundle in a way which suited her, including by not charging a mark-up on the Somatropin which she directly dispensed to the patients to whom she prescribed it. As there was no suggestion that the bundle was loss-leading or that the appellant was not seeking to run her medical practice at a profit, it was open to the Tribunal to consider that the practitioner’s business model took account of the holding costs of $29,000 worth of Somatropin per month.
The appellant identified [290]-[291] (extracted above) as bearing on this ground. It was common ground that the Tribunal’s task when deciding whether a practitioner was guilty of unsatisfactory professional conduct within the meaning of s 139B(1) was to identify “the standard reasonably expected of a practitioner of an equivalent level of training or experience” and then assess whether the appellant’s conduct was “significantly below” that standard.
Ms Mathur submitted that, in substance, the Tribunal held the appellant to the standard reasonably expected of an endocrinologist rather than the standard reasonably expected of a general practitioner of her level of training or experience and therefore had erred in applying the relevant test in s 139B(1).
I am not persuaded that a fair reading of the Tribunal’s reasons indicates that it applied other than the correct standard. The Tribunal said, in effect, that:
any medical practitioner (whether general practitioner, endocrinologist or other medical practitioner) who prescribes HGH (such as Somatropin) off-label must adhere to the same standard of patient monitoring and risk management, because of the nature of such drugs and their potential to cause adverse side effects; and
in order to meet that standard, a medical practitioner (including a general practitioner) who proposes to prescribe such drugs must develop an appropriate understanding of the risks associated with such drugs; of the need to assess patients for suitability for such drugs; and of the way in which monitoring ought be conducted to detect the presence of side effects so as to minimise the risk to the patient.
I am not persuaded that the Tribunal, in making these findings, did other than identify “the standard reasonably expected of a practitioner of an equivalent level of training or experience” as the appellant. That the applicable standard for the applicant, as a general practitioner, corresponded with the applicable standard for any medical practitioner who was prescribing Somatropin (or equivalent) for an off-label purpose, does not make the standard any less applicable to the appellant for the purposes of s 139B(1). This conclusion is fortified by the circumstance that the Tribunal, on more than one occasion, articulated its task in terms which reflect the language of s 139B(1): see, for example [285] (extracted above).
In her submissions in support of ground 1, the appellant raised various factual matters which I do not consider fall within ground 1 and which appear to constitute an attack on the merits of the Tribunal’s decision. It is not necessary to address these. Ground 1 has not been made out.
Ground 2 is extremely wide in its terms. However, when the appellant’s submissions in support of the ground are analysed, ground 2 incorporates a number of separate challenges to the approach taken by the Tribunal which are identified in the appellant’s written submissions. These are:
the Tribunal substituted the “paramount consideration” of the Law for the onus and standard of proof ([269]-[273]);
the Tribunal failed to apply the onus and standard of proof to the expert evidence by failing to “grapple” with differences between the experts and purporting to accept the evidence of each of the experts ([285] and [290]);
the Tribunal inappropriately noted that the redactions to the PRU report were inconvenient ([279]), in circumstances where the Principal Member had ruled that the unredacted PRU report was not admissible;
the Tribunal did not accept the appellant’s evidence as to particular consultations unless it was reflected in her contemporaneous clinical notes when this finding was not open to the Tribunal in the absence of evidence from the appellant’s patients to gainsay the appellant’s own evidence ([280]-[281]);
the Tribunal speculated on matters for which there was no evidence: namely, the circumstances in which HGH can be prescribed “on-label” and therefore be obtained by patients at a subsidised price under the PBS ([283]); and the “rigorous evaluation” conducted by the TGA;
the Tribunal speculated on matters for which there was no evidence and inverted the onus of proof by finding that the fact that the appellant dispensed Somatropin “at cost would be a significant financial incentive for many patients to consult with the practitioner, thereby raising the number of patients attending her consultations” ([314]);
the Tribunal speculated on matters for which there was no evidence and inverted the onus of proof by finding that ageing patients may have a strong predilection for anti-ageing medication, despite its poor prospects of being effective ([336]);
the Tribunal’s finding that the evidence in support of the efficacy of HGH is anecdotal and that it is possible that such anecdotal effects may correspond with the placebo effect was contrary to the expert evidence of Associate Professor Holmes-Walker and misapprehended the applicable standard of proof ([337]); and
the Tribunal engaged in speculation on the characteristics of the appellant’s patient cohort by inferring that they were “drug seeking” ([350]-[353]).
The appellant’s complaint arises from [269]-[273] of the Tribunal’s reasons.
It would appear that the reference to s 3A of the Law is an error (albeit a typographical one) since Sch 1 [1A] of the Health Practitioner Regulation (Adoption of National Law) Act 2009 (NSW) (the Adoption Act) inserts ss 3A and 3B and it is s 3B which provides:
3B 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.
Note—
This section is an additional New South Wales provision.
Schedule 1 [5A] of the Adoption Act defines “NSW provision”, in part, as a provision which forms part of the Law because of a modification made by the Adoption Act. Thus ss 3A and 3B are NSW provisions.
Ms Mathur submitted that the references to s 3A of the Law in the above extract “suggest” that the Tribunal was prepared to rely on its own expertise rather than the evidence and, thus to “substitute proper application of the onus and standard of proof for an inexact exercise driven exclusively by consideration of the protection of the health and safety of the public”.
I reject that submission. I regard the Tribunal’s reasons in [269]-[273] as amounting to a proper acknowledgement that it is exercising a function under the Law and, thus, that, in accordance with s 3B of the Law (which has been inserted by the Adoption Act) the protection of the health and safety of the public must be the paramount consideration. The Tribunal’s reasons, when read fairly and as a whole, indicate the care with which the Tribunal considered the evidence and based its ultimate findings on deficiencies in the appellant’s clinical records and the expert evidence relating to the appellant’s inappropriate dispensing and prescribing of Somatropin and her inadequate monitoring of the risks to which the ten patients were subjected as a result of that drug being prescribed off-label to them for purported anti-ageing purposes.
Sub-ground (1) of ground 2 has not been made out.
Ms Mathur submitted that the evidence of the experts differed in material respects and that the Tribunal’s express acceptance of the evidence of all three experts indicated that it failed to grapple with the differences between them and, in effect, avoided the necessary task of reconciling the differences between them with a view to selecting the evidence it accepted.
As referred to above, the reasons of the Tribunal are to be read fairly and as a whole. There were significant areas of agreement between the experts: including the appropriate standards for monitoring patients receiving HGH off-label for anti-ageing or “wellness” purposes. It is plain from the balance of the wording of [285] that the Tribunal undertook an evaluative exercise in respect of the evidence of each expert with a view to ascertaining the benchmark standard. In these circumstances, when the Tribunal said that it accepted the evidence of all three experts, it cannot reasonably be taken to mean that it accepted every word in the evidence of all three experts, since there were differences in opinion, including as to whether the appellant’s conduct was significantly below the expected standard or merely below it.
I accept the Commission’s submission that while the Tribunal said, at [285], that it accepted the evidence of all three experts, it is apparent from the Tribunal’s reasons, including [291], that the Tribunal weighed and analysed the evidence of the experts and took account of the different perspectives which were reflected in their respective expertise and experience.
It is not necessary to summarise the evidence of each of the three experts to demonstrate that this occurred. It is sufficient to note the following.
Professor Carter considered that a medical practitioner who prescribes HGH off-label has an obligation to ensure that the prescription is not going to cause side effects and is of benefit to the patient (beyond the placebo effect). This obligation required the medical practitioner to assess the patient at appropriate intervals to ascertain whether the risk of side effects had ensued and to monitor whether the desired health outcomes had been achieved, with a view to ceasing the drug if the outcome had not been objectively achieved or side effects were experienced. Professor Carter also considered that objective assessment of side effects by the prescribing medical practitioner was particularly important in circumstances where a patient’s assessment of “quality of life” may, in effect, be unreliable.
Dr Kertesz’s evidence was to similar effect. He said that a practitioner who prescribes such drugs off-label must “monitor patients not only anecdotally but also from a biochemical or a pathology point of view to make sure that the drugs are not detrimental to those patients so that you have a real time monitoring of how they are going rather than those patients just saying ‘Well, I feel better’ or ‘I don’t feel better’”. His view with respect to the appellant’s conduct with respect to each of Patients A-J was, as expressed in his reports and confirmed in cross-examination:
[The appellant] offered off-label and unscientific therapies for patient [A-J] at his[/her] request and with his[/her] permission. There appears to be no medical, clinical or scientific basis for any benefit with this management during the period of prescribing.
Associate Professor Holmes-Walker opined that the appellant had an onus, before prescribing HGH and after having prescribed HGH, to examine the patient’s history and symptoms carefully and weigh the risk of harm against the potential benefit and conduct appropriate screening tests. She considered that the appellant had an ongoing responsibility to monitor those patients for whom she had prescribed HGH at least every six months, which included to test the patient’s IGF-1 levels and reduce the dose of the HGH prescribed in response to any reported or detected side effects. Thus, although there were variations between the experts’ opinions, in terms of nuance and emphasis, there was considerable consensus, as the Tribunal noted.
The Tribunal relied on Professor Carter’s opinions about the need for proper continuing management of patients who were prescribed with HGH because of the significant risk of side effects: [287], [290]-[291], [300] and [303]. It also referred in detail to the evidence of each of the experts in determining the appropriate benchmark standard and the extent to which the appellant fell below it.
I consider that a fair reading of the Tribunal’s reasons indicates that its expressed acceptance of the three experts was tantamount to a statement that the Tribunal regarded each expert’s opinion as reliable, valuable and of assistance in the task to be performed by the Tribunal: namely to evaluate whether the complaints had been made out and to undertake the evaluative assessment of where the appellant’s conduct fell by reference to the benchmark. For these reasons, sub-ground (2) of ground 2 has not been made out.
The appellant submitted that there was no evidence for the findings as to the PBS and the TGA at [283]-[284]. She further submitted that the finding at [284] that the appellant was “circumventing all safety measures, compromising and endangering public safety” by dispensing and prescribing Somatropin off-label to her patients was a serious one to make in the absence of a proper evidentiary basis.
It is significant that the appellant did not contend that the findings about the PBS and the TGA were wrong or that there had been a denial of procedural fairness associated with them but merely that there was no evidence to support them.
As referred to above, s 38(2) of the NCAT Act permits the Tribunal to “inform itself on any matter in such manner as it thinks fit, subject to the rules of natural justice.” It can be expected that the conditions which entitled a patient who had been prescribed with Somatropin on-label (and was therefore entitled to acquire it at PBS rates) and the rigour with which the TGA determines whether a particular drug ought be approved for use in Australia were known to the Tribunal. It is doubtful whether these propositions could, at least at the level of generality expressed by the Tribunal, be genuinely in dispute.
In any event, I consider the Tribunal’s finding that the appellant’s dispensing and prescribing of Somatropin to her patients off-label “circumventing all safety measures, compromising and endangering public safety” was supported by the evidence before the Tribunal. Such evidence included evidence to the following effect:
if Somatropin is prescribed on-label, it must be prescribed in consultation with an endocrinologist and cannot merely be prescribed by a general practitioner without such consultation (as noted by the Tribunal at [290]);
if a prescription is filled by a pharmacist rather than personally dispensed by the prescribing medical practitioner, the pharmacist has a level of oversight of the prescription of the particular drug to the particular patient and is subject to safety guidelines about the purchase and storage of drugs, including Somatropin; and
the appellant’s admission in cross-examination (extracted above) that dispensing Somatropin directly “removes the oversight of the pharmacy as a layer”.
For these reasons, sub-ground (5) of ground 2 has not been made out.
The Appellant accepted that ‘buying somatropin’ from her directly ‘would’ve been cheaper than buying it from a pharmacy under a script’. However, there was no evidence to support a finding that dispensing substances at cost ‘would be a substantial financial incentive’. There was no evidence from any of the Appellant’s patients and no evidence that patients knew, prior to consulting with the Appellant, that she prescribed and dispensed somatropin. To the extent that this matter was put to her in cross-examination, she rejected the proposition.
(Emphasis added and footnotes omitted.)
The effect of this submission is that unless there is direct evidence or an admission which corresponds with the finding made by the Tribunal, it is not open to the Tribunal to make the finding because there is neither evidence nor an admission to support it.
This submission misunderstands the process of fact-finding and drawing inferences from evidence of primary facts. Tribunals of fact, including judges, juries and tribunals, are entitled to draw inferences from primary facts. The law does not regard so-called circumstantial evidence (that is, evidence other than direct evidence or admissions) as less weighty than direct evidence: indeed, it may have greater probative value, particularly if it does not depend on credibility: De Gruchy v The Queen (2002) 211 CLR 85; [2002] HCA 33 at [48] (Kirby J). If it were otherwise, the crime of murder would be positively non-justiciable as the victim, being deceased, cannot give evidence as to what occurred and the accused has the right to silence and, potentially, a motive to lie. Several of the leading cases on circumstantial evidence arise in this context: see, for example, Plomp v The Queen (1963) 110 CLR 234; [1963] HCA 44; Chamberlain v The Queen (No 2) (1984) 153 CLR 521; [1984] HCA 7; The Queen v Baden-Clay (2016) 258 CLR 308; [2016] HCA 35.
As Mahoney JA said in Jones v Sutherland Shire Council [1979] 2 NSWLR 206 at 222 (in circumstances where the rules of evidence did apply):
In the ordinary course of reasoning, whether a fact is capable of being inferred from the existence of given facts, depends upon what has been or is taken to be the human experience as to the relationship which exists between those facts.
There is, as Ms Mathur has pointed out, no direct evidence from the appellant’s patients as to the reason why they consulted with the appellant and whether they were attracted by the circumstance that they could obtain Somatropin from her at a cheaper price than had they had to obtain it on prescription from a pharmacy. Nor did the appellant admit that this would have provided a financial incentive to her patients (although she did, ultimately, admit that, because she sold it at cost, it would have been cheaper for her patients to obtain it from her than from a pharmacy).
While there may have been no direct evidence of a financial incentive, there was circumstantial evidence from which such an inference could be drawn by the Tribunal: that the appellant charged less for Somatropin than a pharmacy would have because she sold it to her patients at cost (and was prepared to incur holding costs, including capital costs and storage costs, to give herself that competitive advantage). This inevitably resulted in the appellant becoming known far and wide (as the evidence established) to those who sought HGH for anti-ageing purposes, who may have had difficulty sourcing it elsewhere or who may have wanted to minimise scrutiny.
The appellant’s denial that her patients had such an incentive was simply a matter for the Tribunal to weigh in the balance. The Tribunal was entitled not to accept her denial (which related in any event to what was in the minds of her patients), including because an admission would have been adverse to her interests in the proceedings. The inference that this price differential would provide a financial incentive for the appellant’s patients to go to her rather than to another medical practitioner who might not dispense Somatropin at cost was at the very least open, if not positively compelling.
The appellant also sought to challenge the final sentence of [314] where the Tribunal noted that as the appellant had not tendered any receipts, it had to rely on her oral evidence as to the cost of consultations, prescriptions and Somatropin. This challenge must fail. The Tribunal’s reasons made plain that it accepted the appellant’s evidence as to these matters, implicitly notwithstanding that she had not produced documentary evidence to corroborate it.
Sub-ground (6) of ground 2 has not been made out.
The appellant submitted that in [336], the Tribunal engaged in speculation and reversed the onus of proof. She relied on the Principal Member’s reasons at [111]-[112] of his minority opinion, which referred to the absence of any complaint by the appellant’s patients and the circumstance that the appellant considered her patients to be well-informed about anti-ageing.
The observations I have made with respect to sub-grounds (5) and (6) of ground 2 also apply to this sub-ground. The Tribunal was entitled to inform itself as it saw fit, subject to the requirements of procedural fairness: s 38(2) of the NCAT Act. Accordingly, it was entitled to consider that at least some individuals who are getting old (with the concomitant reduction in virility, energy, muscle mass and so on) would prefer to halt, defer or reverse the effects of ageing and that this desire might be accompanied by a degree of wishful thinking in otherwise rational people. There was no suggestion that this was, if not a truism, something which could genuinely be disputed. In these circumstances, it is unsurprising that there is no evidence of any patient complaining. Well-informed people may still be credulous and wishful, particularly if they believe that they have access to an elixir of youth.
Further, the evidence of Associate Professor Holmes-Walker extracted above also provides a basis for the inference in the present case since her experience indicated that an individual would come to practitioners such as herself (endocrinologists) wanting HGHs for an “anti-ageing” purpose: in other words, to counteract the effects of age, which are, at least in a physical sense, regarded objectively and experienced subjectively as negative.
For these reasons, sub-ground (7) of ground 2 has not been made out.
The appellant submitted that there was no evidence that any of Patients A-J were drug-seeking or that their levels of drug use allowed the inference to be drawn that they were. On this basis, she submitted that there was no evidence to support the findings at [350]-[353].
This submission appears to be based on the misapprehension that the Tribunal made any finding about the characteristics of the appellant’s cohort of patients in terms of whether they were drug-seeking. When the Tribunal’s reasons are read carefully, fairly and as a whole, it is plain that the Tribunal was concerned that the appellant appeared to be oblivious to, or insufficiently cognisant of, the risk that persons who were drug-seeking would seek her out to obtain HGH for various reasons, including that:
she dispensed to patients directly (thereby avoiding the additional layer of scrutiny which a dispensing pharmacy would have provided);
she did not regard it as suspicious when patients saw her only for anti-ageing concerns and saw their regular or other general practitioner for other health issues;
she did not seek an explanation from patients who lived distant from Bondi Junction, from which she principally practised, and in some cases as far away as Queensland, as to why they had come to her;
her periodic monitoring of patients must have been affected by physical distance from her patients to some degree; and
she was prepared not only to sell Somatropin to her patients at cost price but she would also give discounts for bulk purchases by individual patients.
These matters were all germane to the Tribunal’s assessment of whether the conduct proved against the appellant fell significantly below the expected standard. For these reasons, sub-ground (9) of ground 2 has not been made out.
In substance, the appellant submitted that it was legally unreasonable for the Tribunal not to accept the assessment by Associate Professor Holmes-Walker that the appellant’s conduct fell below, but not significantly below, the relevant standard. In other words, the appellant submitted that the Tribunal was bound to accept her assessment and that any other assessment was legally unreasonable.
The appellant submitted that, if the Tribunal were to reject (or not accept) Associate Professor Holmes-Walker’s assessment on the basis that she was an endocrinologist, the Tribunal was also bound to reject Professor Carter’s opinions on the same basis. She further submitted that there was no reason to distinguish between the opinions of the two endocrinologists on the basis of their expertise, since each was well qualified and experienced.
These submissions misapprehend the task to be performed by the Tribunal. The evidence of the experts was, in the main, opinion evidence. Their opinions were largely accepted by the Tribunal, which took care to reconcile any material differences between them. However, the ultimate question – to what extent the appellant’s conduct, as proved, fell below the requisite standard – was, pre-eminently, one for the Tribunal itself, albeit one in respect of which the experts could give their own opinions, which were taken into account by the Tribunal. The Tribunal’s reasons adequately explain its preference for Dr Kertesz’s and Professor Carter’s assessment. The appellant has failed to establish legal unreasonableness.
This ground is formulated to correspond with authorities which establish that it may be inferred from a decision-maker’s failure to respond to a substantial, clearly articulated argument relying upon established facts, that the matter has not in fact been considered or that there has been a constructive failure to exercise jurisdiction: Dranichnikov v Minister for Immigration and Multicultural Affairs [2003] HCA 26; (2003) 77 ALJR 1088 at [24] (Gummow and Callinan JJ; Hayne J agreeing).
I reject the submission articulated in the term of ground 4. It pays no regard to the Tribunal’s detailed reasoning, based on the expert evidence which was before them both orally and in writing. The Tribunal’s careful analysis of the experts’ opinions and the support, such as it was, for the use of HGH for anti-ageing was ample to deal with the appellant’s submission. Indeed, it is difficult to envisage what more the Tribunal could have said on the topic. Further, it is plain from the structure and content of the Tribunal’s reasons that it had regard to all of the Principal Member’s reasons. It was sufficient, where there was disagreement that they refer to the particular paragraphs and address them. It is not necessary, even for a judge, much less a Tribunal, to recite all of the evidence in the reasons. Reasons ought set out findings and reasoning: this task does not require (and is not improved by) a summary of the transcript or evidence.
For these reasons, ground 4 has not been made out.
The appellant challenged the Tribunal’s rejection of the appellant*’*s evidence of particular consultations ([344]) except in so far as it was reflected in her contemporaneous notes, which the Tribunal did accept, by reference to the paragraphs of the Tribunal’s reasons set out above.
The effect of the appellant’s submissions was that it was not open to the Tribunal to reject her evidence as to particular consultations where there was no evidence from patients to gainsay it and it had not been squarely put to her that her evidence was false. She also relied on the particular wording used by the Tribunal. Ms Mathur submitted that while it would have been open to the Tribunal to reject the appellant’s evidence on the basis that it was unreliable having regard to the length of the intervening period of four years between the particular consultation and the appellant giving her evidence in the Tribunal, that was not what the Tribunal purported to do. Ms Mathur submitted that the Tribunal engaged in a blanket rejection of the appellant’s evidence of particular consultations in so far as her evidence was not reflected in the clinical notes.
The high point of Ms Mathur’s submissions, which she submitted indicated that the Tribunal was applying a blanket rule rather than engaging in orthodox fact-finding, appears from the following extract from [344] (which is set out in full above):
The evidence of what occurred or what was undertaken at the time of the consultation is contained in the patient record. Oral evidence pertaining to specific consultations, some three or four years later, cannot replace a patient record which has been contemporaneously recorded and accordingly we reject the practitioner’s oral evidence on these points. If it is not in the patient record then the actions, justifications and monitoring did not occur despite the practitioner’s ex post facto assertions.
If indeed, Ms Mathur’s interpretation of the Tribunal’s reasons is correct, then this would amount to an error. However, I am not persuaded that the slight infelicity of language in [344] is a fair reading, when one has regard to the other paragraphs which deal with the same issue, which must bear on the way in which [344] ought be read, given the requirement to read reasons, particularly those written by non-lawyers, fairly and as a whole, without an eye attuned to error. For example, [355](iv) and (vi) make it clear that the Tribunal considers the appellant’s evidence of particular consultations (not her evidence as a whole) to be unreliable, having regard to the passage of time. It can also be seen that the Tribunal considered that the appellant had reconstructed the particular consultations, having regard to the reference to “[e]x post facto assertions in respect of patient consultations that occurred some four years prior [being] inherently unreliable” ([355](vi)).
It is true that the Tribunal’s reasons do not conform to the usual verbiage used by trial judges, such as, “[h]aving regard to the passage of time and the witness’ oral evidence, I do not regard the witness’ evidence of particular consultations as reliable except in so far as it is reflected in her clinical notes of such consultations. To the extent to which the witness purported to have a recollection of a particular consultation, I am not satisfied that it is any more than a reconstruction.” Had any one of the three members who constituted the majority of the Tribunal been a lawyer, such a statement may well have found its way into the reasons. There may, in a judge’s reasons, have been a reference to a well-known authority such as Onassis v Vergottis [1968] 2 Lloyd’s Rep 403, in which Lord Pearce said at 431:
It is a truism, often used in accident cases, that with every day that passes the memory becomes fainter and the imagination becomes more active. For that reason a witness, however honest, rarely persuades a Judge that his present recollection is preferable to that which was taken down in writing immediately after the accident occurred. Therefore, contemporary documents are always of the utmost importance.
The Majority, unlike his Honour, has not produced a set of reasons which identify the central issues in dispute, the evidence that related to those matters, and reasons for their critical findings of fact to the Briginshaw standard. The Majority did not express a clear and reasoned view as to what the relevant standard was, or the ways in which the practitioner fell below, or significantly below, that standard. Unlike his Honour’s reasoning, it is difficult to discern from the Majority’s reasons whether or not they found that the practitioner’s conduct fell below, or significantly below the relevant standard because of the mere fact of off-label prescribing, a ‘one dose fits all’ approach, inadequate monitoring, financial incentive to prescribe somatotropin, a combination of those factors, or something else entirely.
The first sentence of this submission is, in effect, a complaint that the Tribunal (comprised of two medical practitioners and a General Member) did not write like a judge, whereas the Principal Member, who was a judge, did. The balance of the submission does not, in my view, give sufficient credit to the reasons of the Tribunal, when read fairly as a whole. The issues that arose were dealt with under convenient headings; the language was, when read fairly, reasonably clear. The Principal Member’s reasons were somewhat discursive and repetitive which may have infected, to a degree, the Tribunal’s reasons, because they were written in response to them. It is, in my view, plain that the Tribunal considered that the appellant’s conduct with respect to the first complaint fell below the relevant standard because of the combination of factors identified, including those identified by the appellant in the last sentence of the extract above.
For these reasons, ground 6 has not been made out.
Professor Holmes-Walker conducted ongoing monitoring at least six months with IGF-1, lipids, glucose, blood pressure, weight and body mass index. All of these considerations are missing from the practitioner’s patient records.
Ground 7 has a degree of superficial attraction. The appellant’s clinical notes in respect of particular patients recorded that some IGF-1 tests were undertaken and the results noted.
However, the Commission submitted that a fair reading of the Tribunal’s reasons did not lead to the conclusion that the Tribunal considered that no such tests were done but rather that the Tribunal considered that such tests as were done were not done for the purpose of determining whether any of the patients had an excess of growth hormone (this being the relevant risk factor identified by Professor Carter in [296]).
I accept this submission. Although Ms Heger did not specifically refer the Court to the appellant’s admission in her reply, it is evident from the following admission that both the Tribunal’s finding and the Commission’s submission are soundly based (set out above but repeated for ease of reference):
I DISPUTE THAT IT WAS NECESSARY TO ORDER GLUCOSE/INSULIN TESTING TO DETERIMINE GROWTH HORMONE DEFICIENCY PRIOR TO PRESCRIBING FOR THIS PATIENT[.] GROWTH HORMONE DEFICIENCY WAS NOT WHAT WAS BEING TREATED. THE HGH MEDICATIONS WERE BEING USED “OFF LABEL” AND THE PATIENT WAS FULLY INFORMED OF THIS, AND OF THE RISK AND POSSIBLE BENEFITS, AND WAS HAPPY TO HAVE THIS REGIME PRESCRIBED. TO SEND THIS PATIENT FOR SUCH INVESTIGATIVE TESTING WAS NOT INDICATED.
(Capitals in original.)
It is apparent from the Commission’s particulars and the appellant’s response that the appellant accepted that she had not ordered tests to determine whether there was growth hormone deficiency before she prescribed Somatropin. Thus, the Tribunal’s findings were entirely in accordance with the appellant’s admission.
The Tribunal was careful in its reasons to qualify its finding that the appellant failed to order tests by purpose (to determine whether there was growth hormone deficiency) and by time (before she prescribed any Somatropin). To read its reasons otherwise is to fail to give each word its meaning in the sentence and in context. The qualifying words as to purpose and time are there because they have work to do. The Tribunal can be taken to be aware that the appellant conducted IGF-1 tests from time to time on her patients: it did not find to the contrary. But what it did find is that those tests were not done for the required purpose. This finding, far from being erroneous, was entirely uncontroversial. The appellant admitted that she had not done any such tests for that purpose before she prescribed Somatropin and maintained that it was not necessary that they be done. The Tribunal was entitled to accept that admission.
While, as referred to above, Ms Heger did not specifically rely in this Court on the appellant’s admission in her reply, the terms of the applicant’s admission are relevant to the question whether leave to appeal ought be granted with respect to ground 7.
As to ground 7(b), it was accepted that the appellant conducted some testing of her patients. The appellant’s expert, Associate Professor Holmes-Walker, said that monitoring of patients to whom HGH had been prescribed must be undertaken at intervals of no more than six months and must involve testing of the markers referred to by the Tribunal at [331]. As referred to above, Associate Professor Holmes-Walker regarded subjective patient assessments of well-being and “quality of life” as “singularly useless” and, therefore, of no value in assessing whether the risk of serious side effects had ensued. Her evidence was that the risk that was otherwise posed to patients who were prescribed Somatropin for “anti-ageing purposes” could only be mitigated by systematic monitoring by objective testing at the stipulated intervals of six months. The evidence established that, while the appellant performed some tests on her patients on an ad hoc basis, her monitoring fell far below what Associate Professor Holmes-Walker regarded as the minimum standard for a general practitioner prescribing Somatropin off-label.
The Tribunal’s findings in [331] could have been expressed differently and possibly more clearly. However, in light of the matters referred to above, I do not consider that ground 7 warrants a grant of leave to appeal. Even if there was, technically, a factual error in the Tribunal’s reasons I am not persuaded that it reflected a material misapprehension of the evidence.
For the reasons given above, I propose the following orders:
Refuse leave to appeal in respect of grounds 7(a) and (b).
Dismiss the appeal.
Order the appellant to pay the respondent’s costs of the appeal.
**********
Della Bruna
Health Care Complaints Commission [2025] NSWCA 105
(2015) 73 MVR 211
(1982) 59 FLR 132
(1938) 60 CLR 336
(1984) 153 CLR 521
(2017) 95 NSWLR 334
(1993) 43 FCR 280
(1994) 49 FCR 576
(2013) 303 ALR 242
(2002) 211 CLR 85
(2003) 77 ALJR 1088
(2020) 104 NSWLR 107
(1937) 59 CLR 467
(1990) 170 CLR 70
(2024) 98 ALJR 610
(2019) 269 FCR 536
(1996) 185 CLR 259
(2019) 100 NSWLR 578
(1989) 16 NSWLR 197
(1963) 110 CLR 234
(2004) 220 CLR 129
(1996) 91 LGERA 1
(2016) 258 CLR 308
(2005) 79 ALJR 1816
(1995) 49 NSWLR 315
(1979) 142 CLR 201
(2024) 98 ALJR 1407
(2013) 252 CLR 480
Leave to appeal in relation to ground 7 was granted; the appeal was allowed; the Tribunal’s orders made on 24 October 2024 were set aside; the matter was remitted to a differently constituted Tribunal; and the respondent was ordered to pay the appellant’s appeal costs ([103]).
In Complaint One, for each of patients A-I further particulars were then provided of when the appellant “inappropriately prescribed” identified drugs, and it was alleged for each that she “failed to appropriately manage the prescribing of the drugs”, where they were prescribed off-label. These particulars said nothing further as to how or why she had “inappropriately dispensed” the drugs. A fair reading of the relevant portions of the Amended Complaint in context is that the dispensing of HGH was inappropriate for the same reasons as its prescription was. For Patient J, similar allegations were made, along with an additional allegation with respect to prescription of other drugs.
Ms Heger accepted that “there’s nothing in this document that expressly says she had a financial incentive and that compromised her objectivity”. Thus the allegation was not made in the place where it should have been.
The appellant filed a “Reply” to the Amended Complaint dated 19 September 2022 which addressed criticism of her directly dispensing HGH. Her reasons included that direct dispensing “is convenient for patients and it protects their privacy as well”. Naturally enough, given that the issue had not been raised, the appellant did not address any issue of claimed financial incentive or suggested lack of objectivity.
The appellant’s solicitor requested further particulars of the Amended Complaint in a letter sent on 12 September 2022. The Commission indicated in its response on 21 September 2022 (provided after the Reply had been filed) that a particular had been added “regarding the dispensing of Somatropin directly to the patients”, which had occurred after an earlier hearing before the presiding member. The letter included a table responding to specific questions asked by the appellant’s solicitor. The table had three columns, without headings. The first column of the table listed the questions; the second column appeared to provide the answer to the questions; the third column appeared to indicate what evidence, standards or the like were relied upon in support of the allegation at issue.
In response to the relevant query, being “what is meant by inappropriate dispensing”, the Commission said the following in the second column:
It has been suggested that the fact that the appellant’s patients had a financial motive to consult her to obtain HGH at cost price necessarily meant the appellant had a financial benefit by way of having a competitive advantage as a doctor. Even if that implied step is accepted, a further significant step is then required to reach the serious finding made by the Majority that the appellant’s objectivity as a doctor in prescribing HGH was compromised by her own financial self-interest. Neither of these two steps was articulated by the Commission.
It has also been suggested that it was open to the Tribunal to consider that the practitioner’s business model took account of the holding costs of $29,000 worth of Somatropin per month. The Majority’s reasons do not suggest that it reached any such conclusion. Its reference at [355(xi)] to “[p]aying for and storing such a valuable inventory” as a reason for creating turnover does not expressly refer to the costs of storage; the appellant was not asked in cross-examination about the costs of storage; and this was not mentioned as part of the Commission’s case in its closing submissions to the Tribunal. Consistently with what is said above at [12]-[16] about reading the decision-maker’s reasons fairly and as a whole, it is not for the Court to speculate about what further unarticulated reasons, if any, lie behind what the Majority said.
A foundational requirement of procedural fairness is that a person liable to be adversely affected by a decision be fairly apprised of the case against them and given a reasonable opportunity to meet it: see eg Johnson v Miller (1937) 59 CLR 467 at 489; [1937] HCA 77; Kanda v Government of Malaya [1962] AC 322 at 337; Commissioner for ACT Revenue v Alphaone (1994) 49 FCR 576 at 591. The person should not be left to guess, nor required to box at vague shadows. It would not have been difficult for the Commission to articulate the point. If it intended to rely on the type of serious finding made by the Majority then it could and should have been articulated in clear terms in the Amended Complaint or, failing that, at least in its answer to the relevant question in the request for further particulars. Neither was done. The Commission’s strained reading of two part-sentences in two expert reports does not meet the required standard.
The Court may readily infer that the appellant may have been able to give evidence in response, such that the failure to comply was a material error: note LPDT v Minister for Immigration, Citizenship, Migrant Services and Multicultural Affairs [2024] HCA 12; (2024) 98 ALJR 610 at [15]. The Commission argued that the finding in question was “peripheral to the majority’s ultimate conclusion”, occupying only a paragraph of reasoning. Yet the impugned part of the decision appeared to have constituted one significant step in the Majority’s reasoning process, presaged by its own heading. So much is confirmed by the fact that the Majority returned to the topic in their summary paragraph at [355], responding point by point to the presiding member’s summary of findings. The finding made by the Majority at [313] of its reasons breached the requirements of procedural fairness in a material manner.
At [355(iv)] the Majority also said that “[o]ral evidence, some four years after a consultation with a patient, from the practitioner pertaining to specific consultations in lieu of entries in the patient record are rejected by the Tribunal”. That statement is a conclusion, not a reason.
As to the first and second reasons as just identified, it is clear that the appellant was required to keep good records, and she conceded she did not do so as well as she should have done by admitting to Complaint Two. But the normative requirement that she keep good records does nothing to establish that her memory is unreliable. It is irrational and unreasonable to suggest otherwise. Usually contemporaneous records will be the most reliable source of evidence. That being said records can be erroneous, in which case the better evidence may indeed be a subsequent explanation. Even leaving such cases aside, the fact that records are generally better evidence does not establish that subsequent explanations are or no value. That is especially true insofar as the subsequent evidence expands upon what is contained in the record. It is a non sequitur to suggest otherwise.
As to the third reason, the limits of human memory are well known and much discussed: see, eg, Watson v Foxman (1995) 49 NSWLR 315 at 318-19; Willmot v Queensland [2024] HCA 42; (2024) 98 ALJR 1407 at [30]. In some cases that leads courts or tribunals to reject the testimony of witnesses. Yet judges, juries and tribunals accept oral evidence as to past events – potentially occurring decades ago – every day of the week. Moreover, memories refreshed from contemporaneous notes are liable to be more accurate than those unsupported by such material.
As the Commission itself submitted, “her admission of inadequate record-keeping … made it all but certain that her oral recollections would come under close scrutiny”. In that context, if her evidence was to be rejected it was critical to explain why that was done, in rational terms. This the Majority failed to do.
The reasoning at [342]-[344] and [355(vi)] must be accepted as the basis for the Majority’s rejection of the oral evidence of the appellant. There is no other reasoning. The reasoning in those paragraphs is not only entirely generic, it is irrational. Accepting that reasons expressed in uncomplicated language mean what they say, read fairly in context, cannot be dismissed as pedantry. Indeed, a contextual reading reinforces that the Majority meant what they said. At [300] the Majority quoted some evidence of Professor Carter which criticised the appellant both with respect to her record-taking and treatment. The Majority then said:
The appellant’s clinical notes routinely preface the recording of blood pressure, pulse rates and weight with the letters “O/E”, shorthand for Observation/Examination. Some of these entries contain added commentary such as “recent bloods” (patient A), “due blood test” (patient B), “sent for blood tests” (patient C), “looks well” (patient D), “review past bloods”, “looks the same” and “Await blood results” (patient E), and “request bloods” (patient F).
By way of example, in relation to Patient A, the appellant made the following observations in her clinical records:
On 12 October 2017, the appellant noted Patient A’s O/E blood pressure score, and that the patient presented “NAD”;
On 26 October 2017, the appellant noted that Patient A’s blood results indicated NAD, and recorded O/E blood pressure and weight. On the same day, Patient A signed the consent for growth hormone form;
On 12 December 2017, the appellant noted Patient A’s blood pressure, weight and height;
On 20 February 2018, the appellant noted Patient A’s O/E blood pressure and weight;
On 9 April 2018, the appellant noted Patient A’s O/E blood pressure presented “nil issues”;
On 26 June 2018, the appellant noted that Patient A’s cognition was improving, and recorded weight and blood pressure;
On 20 August 2018, the appellant noted that Patient A was experiencing “no issues”, and recorded weight and height;
On 22 October 2018, the appellant noted that Patient A was experiencing “no side effects”, and recorded blood pressure;
On 15 January 2019, the appellant noted Patient A’s weight;
On 18 March 2019, the appellant noted Patient A’s recent blood results, and recorded, inter alia, the patient’s IGF levels; and
On 13 May 2019, the appellant noted that Patient A was “feeling great” and recorded the patient’s weight.
By way of further example, in relation to Patient B, the appellant made the following observations in her clinical records:
On 9 January 2018, the appellant noted Patient B’s blood pressure and blood test results including IGF-1 levels. The appellant noted that she discussed with the patient the pros and cons of Somatropin;
On 16 January 2018, Patient B signed the consent for growth hormone form;
On 22 March 2018, the appellant noted Patient B’s blood pressure and weight;
On 20 June 2018, the appellant noted that Patient B reported improved cognition;
On 1 August 2018, the appellant noted that Patient B’s symptoms were stable and recorded blood pressure, weight and height;
On 23 October 2018, the appellant noted that Patient B’s symptoms were stable and recorded blood pressure and weight;
On 5 February 2019, the appellant noted Patient B’s blood pressure and blood test results, including IGF levels;
On 16 April 2019, the appellant noted that Patient B reported “nil issues” and stable symptoms. She measured his blood pressure and weight;
On 17 June 2019, the appellant noted that Patient B would have a break from Somatropin, and measured blood pressure and weight;
On 7 October 2019, the appellant noted Patient B’s blood pressure and weight. The appellant recommenced prescribing Somatropin; and
On 6 November 2019, the appellant noted Patient B’s blood pressure and weight. The appellant also ordered blood tests for Patient B, to be assessed on the “next visit”.
The appellant’s clinical records therefore contradict the Majority’s statement in [328] that IGF-1, blood pressure and weight were “missing from the practitioner’s records”. The appellant also requested pathology reports for Patient B, which recorded IGF-1, lipids, glucose and insulin levels, on 22 January 2019.
The materiality of the Majority’s conclusions with regard to the [mistaken] absence of monitoring may also be seen from [281] where it was said that the “paramount concern” was to protect the safety of the public from “the potential for harm from very serious side effects caused by the prescribing of growth hormones… without adequate serological monitoring for side effects”.
No convincing answer was given to what was conceded by the Commission to be the “legitimate question” asked by the Chief Justice as to “[w]hy would you order the tests unless you were going to assess them?”: see [69] above. The Commission’s position seemed to amount to the proposition that the ordering of pathology tests and the noting of particular results in a patient’s clinical notes was a wholly mechanical act amounting to a solemn farce. Why would tests be ordered in the first place? Why would the practitioner await the results of blood tests if she did not intend to monitor the patients? Why would the results be regularly recorded and some at least of the notes annotated with shorthand expressions such as NAD (“no adverse development”)? Why would weight and blood pressure measurements be routinely taken?
The Majority’s reasoning and conclusions with regard to an absence of monitoring by the appellant, and its significance for their ultimate conclusions, was vitiated by serious misconceptions as to what was done and recorded in the appellant’s clinical notes, examples of which have been referred to above. True it is that these records were not as full as they should have been, and the appellant conceded as much. They were sufficiently full, however, to negate the conclusions of the Majority that the IGF-1 tests had not even been sought and that all of the other ongoing monitoring that Associate Professor Holmes-Walker had indicated was missing from the patients’ records. The evidence was quite to the contrary. Although it is not necessary to speculate how such a fundamental error could have occurred, it may be attributable in part to the long delay between the hearing of the evidence and the final submissions and then to what may be inferred to be the long delay between that event and the formulation of the Majority’s reasons which responded to those of the presiding member.
We are mindful that Adamson JA has accepted the Commission’s submission that “such [IGF-1] tests as were done were not done for the purpose of determining whether any of the patients had an excess of growth hormone” (emphasis in original). Her Honour states at [296]:
The hypothesis for which the appellant contended was that direct dispensing was convenient to her patients (because she regularly re-stocked her supply), saved them the embarrassment of presenting a script for Somatropin at a pharmacy and was not motivated by financial gain (because she sold Somatropin to her patients at cost).
Ultimately, Ms Mathur conceded that the Commission’s case was sufficiently put in its written and oral submissions to the Tribunal. However, she submitted that because it was not sufficiently particularised by the Commission, the appellant was denied the opportunity of giving evidence as to her business model. Ms Mathur also submitted that, although there was no denial of procedural fairness in the Tribunal’s finding that the appellant’s business model might create a financial incentive for her patients to obtain Somatropin directly from the appellant, there was a denial of procedural fairness in the Tribunal’s finding that her clinical judgment was affected by financial motive. Her ultimate submission, as put orally to this Court was:
These matters were canvassed in the oral evidence, as extracted above. Even if the appellant had not given evidence in chief about those matters, they were sufficiently raised in cross-examination by the Commission and questioning from the members of the Tribunal to put the appellant on notice of the importance of the issue (which, as Ms Mathur acknowledged in her oral submissions in the Tribunal, loomed large in the Commission’s case). The forensic opportunity was available: the appellant had the opportunity to give evidence in re-examination on the effect of financial considerations on her professional judgment when directly dispensing Somatropin to her patients, since it had been squarely raised by the cross-examiner and the Tribunal.
While it was unfortunate that the hearing in the Tribunal was so protracted, it is apparent from the transcript of the resumed hearing in March 2024 that both parties had the transcript from the hearing in March 2023 but that the Tribunal did not. Indeed, it was Ms Mathur who provided a clean copy of her transcript to the Tribunal. It is plain from Ms Mathur’s written submissions to the Tribunal that the appellant appreciated, from her cross-examination and from the evidence of the experts, that, relevantly, the Commission’s case in respect of alleged inappropriate dispensing was that her professional judgment was affected by her direct dispensing to patients. While Dr Kertesz’s inference that the appellant was benefiting by a mark-up on the cost price of Somatropin was refuted by the appellant in her oral evidence, this did not dispose of the issue, which remained a live one, as was plain in the course of the evidence. Further, there was an additional safeguard which added to the procedural fairness of the hearing: the appellant, as was customary, was called to give oral evidence last, which meant that she had been privy to all of the evidence adduced by both the Commission and on her behalf before she was required to give oral evidence and be cross-examined.
I am not persuaded that ground 5(a) has been made out.
For these reasons, I would refuse leave to appeal in respect of ground 7.