Health Care Complaints Commission v Grygiel

Background

1. It aids understanding of these reasons if I set out some brief background relevant to the substantive proceedings before the Tribunal. This material includes facts extracted from the practitioner's statement relied on in the substantive proceedings.
2. The practitioner graduated from the University of Sydney with a Bachelor of Pharmacy degree in 1967. He graduated MB.BS from the same university in 1974.
3. In 1980 the practitioner became a fellow of the Royal Australian College of Physicians.
4. In 1984 the practitioner was awarded a doctorate degree in pharmacology at Flinders University, South Australia. Thereafter the practitioner held a post-doctoral position for two years at the National Cancer Institute, National Institutes of Health in the United States of America.
5. On his return to Australia from the USA, the practitioner engaged in practice as a pharmacologist and oncologist at the Mater Misericordia Hospital, Newcastle.
6. In 1989 the practitioner became a staff specialist at Royal Prince Alfred Hospital, Sydney. While working at that hospital, the practitioner treated, among other patients, men and women suffering head and neck squamous cell cancer (HNSCC).
7. In 1991 the practitioner became a Senior Staff Oncologist at St Vincent's, Darlinghurst and took up the post of conjoint Associate Professor of Medicine at the University of NSW.
8. At the time of the events giving rise to the Complaint the practitioner worked on a "fly in, fly out basis" as the treating oncologist for patients suffering cancers, including HNSCC, in the Western NSW Local Health District.
9. In July 2009 St Vincent's adopted protocols, known as eviQ (Evidence + Quality) compiled by the Cancer Institute of NSW, for prescribing chemotherapy drugs. The protocols included protocols for the prescribing of the chemotherapy drugs cisplatin and carboplatin (based on area under the curve calculations) (AUC2) for patients diagnosed with HNSCC and other cancers. The chemotherapy was prescribed as a radio-sensitiser of cells as part of the patients' treatment with radiation. There were separate protocols for HNSCC primary or definitive chemoradiotherapy and post-operative (adjuvant) chemoradiotherapy. eviQ at para 1.3 noted "when there is a need to vary an eviQ policy or procedure for local use, the local service will develop an exception business rule". eviQ noted at para 1.5 that it was "not intended to replicate or replace the knowledge, skill, experience or clinical judgement of experienced health professionals". Professor Clarke has described eviQ as a "cookbook" or recipe for treatment.
10. In about 2013 the then Head of the Oncology Department at St Vincent's, Dr Dalley, retired. Sometime prior to that date the practitioner took over the care of the majority of the HNSCC patients, formerly under the care of Dr Dalley, for their chemotherapy treatment. The practitioner prescribed a "flat dose" of 100mg carboplatin as a radio-sensitiser for many HNSSC patients he treated at St Vincent's, and for patients treated at the Macquarie University Hospital.
11. In 2014 the eviQ protocol was launched on line. The eviQ protocol was later incorporated into MOSAIQ, St Vincent's electronic prescribing facility.
12. On 31 August 2015, the practitioner attended a meeting at St Vincent's. He asserts he was told there was no concern about his prescribing, but he was asked, and agreed, to follow the eviQ protocol prescribing recommendations.
13. On 18 February 2016 the ABC's 7.30 television program broadcast a report which raised criticisms of the practitioner's treatment of patients. The practitioner asserts that no criticism had been raised by St Vincent's about his treatment of patients prior to this report. Subsequently, the practitioner commenced defamation proceedings against the ABC which were settled. On 2 April 2019 the ABC notified the practitioner it had published an apology on its website. The practitioner, who had been proposing to retire, took sick leave after the publication of the 7.30 Report and has not thereafter practised medicine.
14. On 19 February 2016 the then Secretary of the New South Wales Ministry of Health instituted an inquiry under s 122 of the Health Services Act 1997 (NSW) into "Off-protocol prescribing of chemotherapy for head and neck cancers". The inquiry focussed principally on the organisational response at St Vincent's to allegations made against the practitioner.
15. On 31 March 2016 an interim report was published by the s 122 Committee.
16. On 26 May 2016, following proceedings under s 150 of the National Law, conditions were placed on the practitioner's registration. In summary, the conditions required he prescribe in accordance with the eviQ protocol and practise under level C supervision in accordance with the Medical Council of NSW supervision policy.
17. The final report of the s 122 Committee was released on 2 August 2016.
18. In August 2016 a NSW Parliamentary Inquiry by a Legislative Council Select Committee was established into off-protocol prescribing of chemotherapy in NSW. The Committee published its report in May 2017.
19. On 9 November 2019 the practitioner was registered as a non-practising practitioner. After an oral application was made on behalf of the practitioner for the termination of these proceedings, the practitioner applied to the Australian Health Practitioner Regulation Agency (AHPRA) for removal of his name from the register. On 8 April 2020 he signed a statutory declaration in which he deposed that he did not intend to ever seek re-registration.

The relevant statutory provisions

1. Clause 12 of Schedule 5D of the National Law provides as follows: 12 Certain complaints may not be heard [NSW] (1) A Committee or the Tribunal may decide not to conduct an inquiry, or at any time to terminate an inquiry or appeal, if - (a) any of the following circumstances apply - (i) a complainant fails to comply with a requirement made of the complainant by the Committee or the Tribunal; (ii) the person about whom the complaint is made ceases to be a registered health practitioner or student; (iii) the complaint before the Committee or the Tribunal is withdrawn; and (b) in the opinion of the Committee or the Tribunal it is not in the public interest for the inquiry or appeal to continue. (2) A Committee or the Tribunal must not conduct or continue any inquiry or any appeal if the registered health practitioner or student concerned dies. (3) The power conferred on a Committee or the Tribunal by this clause may be exercised by the Chairperson of the Committee or the member of the Tribunal presiding and, if exercised by the Chairperson or member, is taken to have been exercised by the Committee or the Tribunal.
2. Section 55 (1) of the CAT Act is as follows: 55 Dismissal of proceedings (1) The Tribunal may dismiss at any stage any proceedings before it in any of the following circumstances - (a) if the applicant or appellant (or, if there is more than one applicant or appellant, each applicant or appellant) withdraws the application or appeal to which the proceedings relate, (b) if the Tribunal considers that the proceedings are frivolous or vexatious or otherwise misconceived or lacking in substance, (c) if the applicant or appellant (or, if there is more than one applicant or appellant, each applicant or appellant) has failed to appear in the proceedings, (d) if the Tribunal considers that there has been a want of prosecution of the proceedings. (2) The Tribunal may reinstate proceedings that have been dismissed under subsection (1) (c) if the Tribunal considers that there is a reasonable explanation for that failure.
3. As will become apparent later in these reasons, the oral and written submissions of the parties address other provisions of the National Law and the CAT Act. Accordingly, it assists in understanding the submissions, and my consideration of them, if I now set out the relevant provisions.
4. Both parties place emphasis on differing sub-sections of the objects provision of the National Law (s 3) and the NSW object and guiding principle found in s 3A. Those provisions are as follows: 3 Objectives and guiding principles (1) The object of this Law is to establish a national registration and accreditation scheme for - (a) the regulation of health practitioners; and (b) the registration of students undertaking - (i) programs of study that provide a qualification for registration in a health profession; or (ii) clinical training in a health profession. (2) The objectives of the national registration and accreditation scheme are - (a) to provide for the protection of the public by ensuring that only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered; and (b) to facilitate workforce mobility across Australia by reducing the administrative burden for health practitioners wishing to move between participating jurisdictions or to practise in more than one participating jurisdiction; and (c) to facilitate the provision of high quality education and training of health practitioners; and (d) to facilitate the rigorous and responsive assessment of overseas-trained health practitioners; and (e) to facilitate access to services provided by health practitioners in accordance with the public interest; and (f) to enable the continuous development of a flexible, responsive and sustainable Australian health workforce and to enable innovation in the education of, and service delivery by, health practitioners. (3) The guiding principles of the national registration and accreditation scheme are as follows - (a) the scheme is to operate in a transparent, accountable, efficient, effective and fair way; (b) fees required to be paid under the scheme are to be reasonable having regard to the efficient and effective operation of the scheme; (c) restrictions on the practice of a health profession are to be imposed under the scheme only if it is necessary to ensure health services are provided safely and are of an appropriate quality.
5. Section 3A provides as follows: 3A Objective and guiding principle [NSW] In the exercise of functions under a NSW provision, the protection of the health and safety of the public must be the paramount consideration.
6. The practitioner's submissions also refer to cl 7 of Schedule 7 of the National Law. The clause is in the following terms: 7 Interpretation best achieving Law's purpose (1) In the interpretation of a provision of this Law, the interpretation that will best achieve the purpose or object of this Law is to be preferred to any other interpretation. (2) Subclause (1) applies whether or not the purpose is expressly stated in this Law.

The evidence relied on in support of the application

1. The practitioner relies on his affidavit sworn on 23 March 2020. He also relies on correspondence from his solicitors forwarded to AHPRA on 27 March 2020 and his Statutory Declaration dated 8 April 2020. In the correspondence the practitioner seeks to have his non-practising registration as a medical practitioner cancelled.
2. The HCCC did not object to a number of statements made by the practitioner in his affidavit, including a number of expressions of opinion or otherwise inadmissible material. Although the Tribunal is not bound by the rules of evidence in respect of admissibility, I have disregarded or not given weight to plainly inadmissible material in the affidavit.
3. In paras 1 to 12 of his affidavit the practitioner deposes to conduct, which he categorises as harassment, that he and members of his family experienced from the media and others following the broadcast by the ABC of a "7.30" program. The practitioner deposes that, in 2016, he received two death threats over the telephone at his family home, and an obscene communication in the mail.
4. The practitioner refers, at para 13, to a NSW Parliamentary Committee hearing conducted in 2016. He states at para 14: It was a very distressing experience and I felt personally attacked. I felt the questions were personally offensive and ill-informed. These hearings triggered further media interest in me.
5. At paras 15 to 18 of his affidavit, the practitioner deposes to his practise of medicine noting that he has worked for the majority of his career in public hospitals. He makes the statement "I have always had the best interests of my patients in mind when recommending treatment … and have always put my patients' interests first". He explains that he had planned to retire three weeks after the first 7.30 Report. He then says "However, after the First 7.30 Report aired, I went into shock and immediately went on sick leave and never returned to work".
6. At para 17, the practitioner deposes that his mental health suffered and he sought medical advice from his family practitioner. He states "I was diagnosed with reactive depression and underwent treatment with a consultant psychiatrist in Gordon for the next 12 months". The practitioner deposes to continuing to consult his general practitioner who he says has monitored his condition, especially leading up to and during the tribunal hearing.
7. At para 19, the practitioner deposes to suffering ongoing stress and "guilt over the negative impact" the matter has had on his family "particularly now as this hearing has extended to more than 4 years after the First 7.30 Report". He goes on, at para 21, to note that in July 2016 he received a letter from the University of New South Wales which advised, due to findings in the reports "prepared by David Currow" that he had been stripped of his UNSW Associate Professor title. I pause to note that Professor Currow was the Chair of the s 122 inquiry.
8. The practitioner deposes, at para 22, that he received a call from a Daily Telegraph journalist. He says the following day St Vincent's sent him a letter informing him "that I had been fired". The practitioner commenced unfair dismissal proceedings against the hospital in 2016 which proceedings were settled in January 2017.
9. The practitioner also deposes to commencing defamation proceedings against the ABC in February 2017. In February 2018 he states that, following mediation, the proceedings were settled and a public apology was issued by the ABC.
10. At para 27, the practitioner explains that in December 2016 his wife, to whom he had been married for 41 years, was diagnosed with cancer. Mrs Grygiel died on 6 June 2017.
11. At paras 31 to 33 of his affidavit, the practitioner deposes to his dependence on his children for support during medical inquiries, court proceedings and legal proceedings. He deposes that two of his children had to access Mental Healthcare services which he attributes to "this ongoing case".
12. At paras 34 to 39 the practitioner refers to the history of these proceedings, including receiving requests for responses to questions from the HCCC throughout 2016. He records, correctly, that the NCAT proceedings commencing on 29 July 2019, and that "on the first day of the hearing, the HCCC informed us that it had dropped 3 or 4 cases out of the 57 nominated in the complaint. Following the adjournment in July 2019 the HCCC confirmed there were further patients and particulars that were dropped".
13. In the final two paras of his affidavit the practitioner deposes to the late disclosure of three reports by Professor Richard Fox. He asserts that he does not "think I can cope much longer. I am exhausted".

The parties' submissions

1. Both parties provided detailed written submissions relevant to this application. I thank the parties for those submissions. The practitioner relies on the written and oral submissions of his senior and junior counsel, including written submissions dated 27 March 2020 and submissions in reply dated 8 April 2020. The HCCC relies on the written and oral submissions of senior and junior counsel, and in particular, the written submissions dated 3 April 2020.

The practitioner's submissions

1. After referring to the two statutory provisions relied on in this application, the practitioner's submissions note, at para 5, that "in contrast to the National Law" the exercise of power under s 55 does not "require an express requirement to consider the public interest". Reference is made to statements in Heath Care Complaints Commission v Duggan [2015] NSWCATOD 142 that although the National Law and CAT Act operate in conjunction, the National Law objectives are overriding when considering an application to terminate proceedings. It is submitted "This does not mean, however, that recourse to s 55 (1) is impermissible".
2. It is submitted on behalf of the practitioner that, having regard to the decision of Sackville AJA in Medical Council v Lee [2017] NSWCA 282, the CAT Act is only inoperative if there is an inconsistency or repugnancy between s 55 of the CAT Act and the National Law. It is submitted that this is not the situation here because: There is no inconsistency between s 55 and the National Law. In addition, Sch 5 of Cl 12 of the National Law does not constitute an exhaustive or definitive regime for bringing proceedings to an end. In fact, the public interest underpinning s 55 is the same as that under Sch 5 cl 12. Section 55 essentially provides further particulars as to when it will be appropriate to bring proceedings to an end. It cannot be in the public's interest about health and safety for proceedings that are frivolous, vexatious or otherwise misconceived or lacking in substance to continue. Likewise, it must be in the public interest to dismiss proceedings when, as here, it is just, quick and cheap to do so (s 36 (1) CAT Act).
3. The submissions then deal with the topic of "Public Interest considerations" commencing with an extract from the judgment of the Full Court of Federal Court in McKinnon v Secretary, Department of Treasury [2005] FCFC 142 at [245].
4. It is submitted that, in considering relevant aspects or facets of public interest, regard must be had to relevant provisions of the National Law. Attention is drawn to cl 7 (1) of Schedule 7. Reference is also made to s 3A (the NSW objects provision).
5. Paragraphs 13 and 14 of the submissions are directed to s 3A. It is submitted: But s3A is neither the beginning nor the end of the analysis. This point needs to be made at the outset. Section 3A cannot be invoked as a cure all to be used reflexively by the Commission or the Tribunal to justify the continuance of the proceedings, and to remedy misconceptions about the nature of the Complaint or the evidence. Likewise, the alleged seriousness of the complaints is not determinative. It is necessary to have regard to aspects of public interest in health and safety raised by the objectives and guidelines in section 3. On the contrary, scrutiny of the relevant provisions reveals a far more nuanced and pragmatic approach on the part of the legislature. Certain "real world" factors must also be considered, including the facilitation of access to services, the flexibility and sustainability of the health workforce, and the efficiency and fairness of the scheme (which includes fairness to doctors). Only if all these factors are balanced appropriately will the public interest be served [original emphasis]
6. At para 15, it is submitted that public health and safety "is best protected by the maintenance of an efficient, effective and sustainable health system, accessible to everyone, and fair to all participants within it, including doctors".
7. The submissions note that the opening submissions of senior counsel for the HCCC relied on the decision of the Court of Appeal in Health Care Complaints Commission v Do [2014] NSWCA 307. It is asserted that the emphasis of the court in HCCC v Do was, on the facts before it, on s 3A and s 3(2) (a) and s 3 (2) (e). It is submitted that the facts in Health Care Complaints Commission v Do were very different to this case. It is submitted that it is difficult to see the relevance of s 3(2) (a) of the National Law to this case, although the provision was relied on by the HCCC in its opening at the substantive hearing. This is because, it is submitted, there is no issue as to the practitioner's training and qualifications and that he is not practising and does not intend to do so.
8. At paras 21 and 22, the submissions address s 3(2) (e) of the National Law. The submissions in these paras go, in a number of respects, directly to the issues the practitioner's counsel submit support the present application. It is submitted: Medical services are provided in NSW through a combination of public and private facilities. One of the keys to the system's operation is ensuring a sufficiently large cohort of suitably qualified and trained (and motivated) doctors, in all geographical areas, and at all levels of experience - but perhaps especially at the most experienced level. Doctors are human beings, not robots. It is submitted that eminent time-poor specialists (as was Associate Professor Grygiel when practising) must be able to provide their services in public hospitals, and in under-resourced regional areas, without being so overburdened as to make it a disincentive for them to do so. The source of such overburdening may be the imposition of excessive and unrealistic legal obligations and the ever-looming threats of civil litigation and professional disciplinary proceedings. It includes blind adherence to guidelines based on low-level evidence (such as carboplatin AUC2 protocol). It includes additional requirements for annotating a consent form to validate consent, with matters already expressly stipulated in pre-approved pro-forma consent forms.
9. The submissions go on to argue that s 3(2)(f) (the object provision relating to a "flexible, responsive and sustainable Australian Health workforce") requires consideration be given to the fact that doctors who work in "under resourced or stretched public health outpatients departments may be affected by increased insurance premiums and impractical legal obligations. Blind adherence to guidelines or protocols held out as being evidence based is not part of a flexible medical workforce".
10. The submissions then address s 3(3)(a) of the National Law with emphasis on the scheme working in a fair way, and advance the proposition that doctors should not be required to protect themselves against "the spectre of possible legal complaints, especially those generated by the media and spurious 'off protocol' allegations".
11. The submissions address the issue of fairness to the practitioner and ask rhetorically is it fair that the practitioner, "an eminent specialist", should be prosecuted for professional misconduct when he is in retirement? Further questions relating to asserted unfairness are chronicled - a trial by media, a Select Committee inquiry and s 122 investigation. It is submitted that both the Select Committee and the s 122 investigation "did not result in the removal of 'clinical judgment' from the practice of medicine and did not result in the mandatory application of protocol treatment regimens" [original emphasis].
12. It is submitted, relying on s 3(3) (c) of the National Law, that the proceedings "were and are unnecessary. They are vexatious". It is submitted: If and to the extent that it might have been useful to conduct a debate in relation to the relative merits of the different drugs in issue (carboplatin or cisplatin) and the appropriate dosage, such a debate could and should have been conducted by other means other than disciplinary proceedings. At worst, this is a case of failure to provide services of what one group of oncologists consider to be optimal quality, rather than the provision of services "significantly below" an "appropriate" standard.
13. The submissions refer to finite judicial resources and submit such resources should not be wasted "on practitioners who are no longer registered". It is submitted the situation caused by the coronavirus pandemic is highly relevant, and that this pandemic means scarce legal and medical resources should not be further expended, particularly in the case of an unregistered practitioner.
14. Having drawn attention to the decision of the former Medical Tribunal of NSW in Re Parajuli [2010] NSWMT 3 and the discussion by Meagher JA in Health Care Complaints Commission v Do about the paramount purpose of protective orders, it is submitted that continuation of the proceedings to protect the public is unwarranted. It is thus submitted that the continuation of the proceedings can only be a matter of general deterrence, as any other basis would be punitive.
15. At para 38, it is submitted that "proper analysis" of the complaint will not provide any legitimate deterrence of medical practitioners and "it is pointless to view this case as providing a suitable vehicle in which to test some of the putative general issues. In any event, the Complaint is hopelessly misconceived".
16. The submissions thereafter refer to a number of cases where the Tribunal has determined not to hold an inquiry in relation to a practitioner who is no longer registered (see Health Care Complaints Commission v Torrinello [2015] NSWCATOD 90; Health Care Complaints Commission v Perry [2015] NSWCATOD 76). I pause to note in both these cases the applicant under cl 12 of Schedule 5D of the National Law was the HCCC. Three criterion were identified as relevant to the public interest in those cases. First, the practitioner, as in this case, was no longer registered. Secondly, it was noted the subject matter of the complaint could be taken into account by AHPRA on any application for re-registration, and that the HCCC could seek to have the proceedings re-instated or file a new complaint if the practitioner did seek to be re-registered in the future.
17. The submissions also refer to the factors considered relevant in making orders under cl 12 of Schedule 5D in Health Care Complaints Commission v Khan [2014] NSWCATOD 83 and Health Care Complaints Commission v Harley [2014] NSWCATOD 110.
18. Under the heading "Why an inquiry should not be held" the submissions highlight the fact that the practitioner held non-practising registration on and from April 2016, and because of the expenses and resources involved in the case. These are described as "out of the ordinary and considerable". It is noted that the hearing will consume a total of four weeks hearing time with the Tribunal required to consider 27 volumes of material. Reference is made to the fact that these proceedings involve five senior members of the medical profession (being the two Tribunal professional members and two of the three expert witnesses) being unavailable for patient care. It is submitted: There is no ability to deal with these complaints in an 'efficient' and 'effective' way when 53 patients' clinical records need to be read and considered along with over 200 referenced articles.
19. It is submitted, at para 48, that regard must be had to the "stale" nature of the complaints stretching over 5 to 10 years, and in particular in circumstances where literature relied on by the HCCC's expert, "often post dates events demonstrating both the ever changing nature of the optimal dosing regimens, but more importantly, the complete lack of certainty and clarity with respect to what is the optimal and most efficacious dosing regimen in head and neck and colorectal cancer".
20. The submissions next refer to a number of matters addressed by the practitioner in his affidavit in support of this application.
21. At para 54, it is noted that, if the proceedings are not terminated, that there will be further delay "until much later in 2020" before the evidence can be finalised with submissions and judgment to follow". It is further noted, if any part of the Complaint is proved, that there will be further delay for the Tribunal to re-convene to consider appropriate protective orders.
22. At para 56, the submissions refer to evidence given by Dr Stein immediately prior to the adjournment of the hearing. It is submitted that Dr Stein gave "telling evidence against the investigations and inquiries that [the practitioner] has already endured". The submissions refer to a concession made by Dr Stein that a study by Porceddu et al (2004) provides "low level evidence" for the AUC2 eviQ protocol in the adjuvant setting of chemoradiation (transcript p 751.43). It is submitted that Dr Stein: … agreed that in the absence of a head to head study of radiation alone against radiation in combination with carboplatin AUC2 one cannot establish whether the carboplatin dose in the eviQ protocol is in fact efficacious. (Transcript 751.48- 752). He also conceded that there is no published data directly supporting the prescription of carboplatin AUC2 in head and neck cancer in the post-operative setting (transcript 752.8-12).
23. The submissions then refer to the fact that the AUC2 carboplatin protocol was superseded in October 2016 "because of insufficient evidence supporting its use". The submissions on this topic suggest it is "unfathomable" how the practitioner was ever investigated "and prosecuted for 'off-protocol' prescribing" when "the protocol in question was based on such unconvincing foundations". Thus, it is submitted it cannot be in the public interest for the inquiry to continue particularly in circumstances where the HCCC "still maintains it was improper and unethical to prescribe 'off protocol'".
24. After quoting from the opening statement made by Ms Stern, it is submitted that the HCCC case is "that to prescribe outside of eviQ protocols was not simply significantly below the standard expected but unethical and improper". Having noted, correctly, that the Tribunal is bound in its decision making by the particulars of the complaint, it is submitted that the Tribunal's decision "is unlikely to be couched in terms of 'off protocol' prescribing". The submissions again rhetorically pose the question "What is the utility of this Complaint as a result, so far as general deterrence and the reputation of the professions is concerned?"
25. At paras 58 to 61, the submissions summarise parts of the Joint Expert reports, including the view of all experts that there is no evidence to support a finding that the practitioner caused harm to any patient (Exh 28-49-15216). It is submitted that "How the proceedings remain matters of public interest is thus opaque".
26. The primary submissions conclude with a critique of the particulars of Complaint 2A (a complaint about Patient M2) and Complaint 2B (the record keeping complaint).
27. It is submitted that the allegations in the complaint are unclear and no longer supported by Dr Stein, contrary to the joint expert reports and "misconceived".
28. At para 70, the submissions refer to evidence of Dr Stein. It is submitted he conceded in cross-examination that there is "published data that shows that a cumulative dose of 600mg carboplatin has efficacy in the treatment of head and neck cancer (transcript 771.1-6) and that it is false to assert that there is no published data supporting the prescription of a cumulative dose of 600mg [original emphasis].
29. At paras 71 and 72, it is submitted that Dr Stein agreed there is no high-level evidence establishing that cisplatin is superior to carboplatin (transcript 788.10-33), that there were oncologists who preferred prescribing carboplatin to cisplatin as part of chemoradiaton, and that there was no large scale trial that showed cisplatin was superior to carboplatin. It is further submitted that "it is unlikely that there was any obligation on [the practitioner] to prescribe cisplatin rather than carboplatin when both were equally efficacious". It is also submitted there was no obligation to inform a patient there was another drug, namely cisplatin, if there was no high-level evidence showing it was superior to carboplatin.
30. The submissions are critical of the drafting of particular (c) of complaint 2A describing the particular as "misconceived" and unable to stand on its own.
31. In submissions in reply to those provided by the HCCC, the practitioner's counsel submit that it is not necessary to continue these proceedings to publicly denounce the practitioner in respect of the alleged failure to obtain informed consent from his patients. It is submitted that there are many other cases which deal with informed consent, and it is unnecessary for this matter to be continued on that basis. It is submitted that the HCCC's case is that patients should have been told that the prescription of carboplatin was "off protocol" and that this allegation is misconceived.
32. The submissions take issue with a submission made by the HCCC, at para 16, that public confidence in the profession would be diminished if a medical practitioner could avoid disciplinary proceedings by surrendering his or her registration because the practitioner had not, at the time of the submissions undertaken on oath not to seek re-registration. It is submitted that the HCCC's submissions ignore s 80 of the National Law.
33. At para 15 of the submissions in reply, the practitioner's counsel refer to the practitioner's concession in cross-examination that he was unaware of any studies "specifically looking at carboplatin 100mg weekly for six weeks with radiation" and the HCCC's assertion this underscores how serious the allegations are. It is submitted the HCCC's reference to this aspect of the cross-examination is strange when the practitioner had "already stated in opening that there was no study specifically testing that regimen". It is submitted the HCCC's submission fails to address "the significance of the oral evidence that followed from all three experts".
34. The submissions in reply re-inforce the substantive submissions about future likely costs and delays. Para 19 of the submissions in reply suggests that it cannot be assumed the practitioner's professional indemnity insurance will cover his legal costs and that "there is a potential he may have to pay for the continuation of the proceedings himself". I pause to note that there was no evidence before me which would enable me to make a finding about the practitioner's legal costs or his personal liability for them. Accordingly, I have not placed any weight on this aspect of the submissions.
35. At paras 38 to 43, the submissions advance the proposition that the continuation of the proceedings is punitive and that they are being prosecuted only on the basis of general deterrence. Because of the serious nature of the allegations, it is submitted that the appropriate standard of proof should be the criminal standard, rather than on the balance of probabilities. However, if that submission is not accepted, it is submitted that the principles in Briginshaw must be followed in this case.
36. Aspects of the written submissions were highlighted in the oral submissions made at the telephone hearing conducted on 9 April 2020.

Submissions made on behalf of the HCCC

1. The submissions of counsel for the HCCC cover three broad topics. First, it is submitted that the practitioner has not established any "legitimate" basis for the exercise of the Tribunal's discretion to terminate the inquiry. Secondly, it is submitted that cl 12 of Schedule 5D of the National Law operates to the exclusion of the CAT Act and thirdly, if I do not accept the previous proposition, the proceedings do not constitute an abuse of process such as to warrant their summary dismissal under s 55(1)(b) of the CAT Act.
2. The submissions refer to the statement of the plurality in the High Court in O'Sullivan v Farrer (1989) CLR 210 and submit that "attention is shaped and confined by the subject matter, scope and purpose of the National Law". I note that there is no dispute between the parties about the authorities or principles derived from them about "public interest".
3. The submissions advance the argument that, although s 3 and s 3A of the National Law are relevant, what is of less relevance are those provisions of s 3 directed to the registration of health practitioners. Emphasis is placed on Part 8 of the National Law dealing with the Tribunal's disciplinary powers. It is however noted that ultimately, in the exercise of discretion, s 3A which addresses the health and safety of the profession, must be the paramount consideration. Reference is made to the principles enunciated by Meagher JA, with whom Basten and Emmett JJA agreed in Health Care Complaints Commission v Do at [35]. It is submitted, therefore, it is not just risk to the public if the practitioner were to again practise, but the need to have the conduct asserted in the Complaint denounced as unacceptable "so as to operate as both a specific and general deterrent and the maintenance of public confidence in the standards of the medical profession". It is submitted, contrary to the submission made on behalf of the practitioner, that the factual circumstances underlying the decision in Health Care Complaints Commission v Do do not detract from the statement of principle in that matter. It is submitted the reliance placed by the practitioner on the surrender of his registration, and his retirement without returning to practice does not address the issue of specific or general deterrence.
4. The submissions for the HCCC assert the practitioner has not prepared a document on oath saying he will not practise again. However, I observe that this submission was prepared prior to the practitioner swearing on oath in a Statutory Declaration that he will not again seek registration.
5. It is submitted, the time the proceedings have been on foot, and the number of hearing days which have already occurred, are matters which weigh heavily against terminating the proceedings. The submissions refer to the matter of Health Care Complaints Commission v Duggan [2015] NSWCATOD 142 at [42]. I noted that was a case where an Osteopath, at the commencement of disciplinary proceedings, made an application for termination of the proceedings on the basis he had been acquitted of criminal charges of inappropriate touching and sexual misconduct, that he was no longer registered and would not practise again as an Osteopath. The Tribunal refused the application noting at [42] the importance of general deterrence.
6. Having referred to a number of decisions of the Tribunal where orders have been made under cl 12 of Schedule 5D, the submissions note, in each of the cited cases, the application was either made by the HCCC or the HCCC consented to the application. Reference is made to the discussion in Health Care Complaints Commission v Duggan at [50] of the relevance of the Director of Proceedings determining to seek withdrawal, or to consent to it, on the basis that "the HCCC has itself already undertaken a consideration of the health and safety of the public". The submissions note the obligations on the HCCC by reason of s 90C of the Health Care Complaints Act 1993 (NSW).
7. At para 24 of the submissions the HCCC lists six criteria that have been considered by the Tribunal in determining an application under cl 12 of Schedule 5D. It is useful that I repeat the criteria listed. They are: 1. The seriousness of the alleged misconduct and the practitioner's denial thereof (or I would add, admissions made by the health professional); 2. The expense likely to be incurred, the demands on the resources of the Tribunal and the delay occasioned if an inquiry proceeded; 3. That the practitioner has voluntarily surrendered registration and undertaken on oath not to seek registration; 4. Any determination by the Commission with the agreement of the Medical Council not to proceed with the prosecution of the complaints; 5. The impecuniosity of the practitioner; and 6. The ill health of the practitioner which would preclude him or her from engaging in further practice.
8. The submissions then address the six identified criteria. Paras 26 to 40 of the submissions deal with the seriousness of the complaints. At para 27 it is submitted that the Complaint addresses "more than 50" patients undergoing chemotherapy or chemoradiotherapy treatment for various forms of cancer predominantly HNSCC between November 2007 and December 2015. It is submitted the allegations concern "the practitioner's decision to prescribe a flat dose of 100mg carboplatin which is not supported by published evidence as to efficacy, and other complaints of under-dosing of chemotherapy drugs or a failure to use chemotherapy regimens which are supported by published evidence and instead using those that were not".
9. Paragraph 27 also addresses, in broad terms, the balance of the complaints against the practitioner (an asserted failure to obtain informed consent from patients, and record keeping failures). It is submitted that the particulars either individually or cumulatively amount to professional misconduct under s 139E of the National Law.
10. It is submitted that, on this application, it would be erroneous to disregard the evidence of Dr Stein and the criticisms he makes of the practitioner's conduct. It is also submitted that "there is considerable support for the Complaint to be found in the evidence of [the practitioner's] expert witnesses". In support of this submission, it is noted that Professor Fox agrees with Dr Stein that the practitioner's written records "re informed consent were inadequate and below standard". It is also noted that Professor Fox agrees with Dr Stein that the documentation of the practitioner was "significantly below the standard".
11. At para 31 of the submissions, reference is made to the fact that all experts agree that the treatment provided by the practitioner was below standard, and that the only issue for the Tribunal is whether the conduct was "significantly so" and whether individually or cumulatively it constitutes professional misconduct.
12. In the same para it is noted, first, that all experts agree that 100mg carboplatin chemoradiotherapy has not been directly demonstrated to be better than radiotherapy alone (Transcript 22 October 15.221) and that low dose capecitabine has not been directly demonstrated to be better than radiotherapy alone (Transcript 22 October 15,222. It is further submitted that Professor Clarke agrees with Dr Stein that "it does not make sense to use a flat dose [of carboplatin] as it is the one chemotherapy drug for which we have a simple and reliable means of controlling variations in blood levels" (Transcript 22 October 15.221).
13. Para 32 of the submissions addresses the question of the patients' consent. It is submitted that all experts agree that consent is a real and substantial issue and that "adequate discussions would have ameliorated their concerns". Reference is made to the evidence in the joint report of Dr Stein and Professor Clarke that the practitioner's rationale for prescribing a flat dose of 100mg carboplatin and low dose capecitabine is not clearly articulated in the practitioner's notes "or subsequently". The submissions note the difference in approach to the question of informed consent, namely that Dr Stein finds the practitioner's actions to be significantly below the expected standard while Professor Clarke opines that it was not up to the standard expected now. Professor Fox's comment that "as it was not recorded it could not be assessed" is also noted.
14. The submissions, at para 33, note a number of concessions made by the practitioner in cross-examination namely that he was not aware of any other practitioner in Australia routinely prescribing 100mg carboplatin rather than carboplatin AUC. It is also noted that the practitioner accepted there is no published study that tests a protocol or guideline of 100mg carboplatin as part of chemoradiation for HNSCC, and that he accepted there is no study testing whether carboplatin is more efficacious than radiation alone or more efficacious than AUC dosing of carboplatin or more effective than cisplatin. It is submitted "Those concessions underscore the seriousness of the allegations in the Complaint".
15. The submissions then address the evidence of a number of patients that they had placed immense trust in the practitioner, and submit that the practitioner had great power over a vulnerable cohort of patients. Reference is made to authorities which discuss the trust which patients repose in a doctor. It is submitted that the issue of trust and power in light of the practitioner's prescribing reinforces the seriousness of the Complaint and "the significant public interest in ensuring that medical practitioners uphold and adhere to the high standards of the medical profession".
16. At para 38 the submissions record: The Tribunal is therefore tasked with examining the conduct of a senior specialist in administering highly toxic chemical agents to a large number of vulnerable patients over a period of nearly eight years in circumstances in which: (a) significant important concessions from [the practitioner] support the Complaint, and (b) the experts have all provided reports, including joint reports, but cross-examination of the experts has not yet been completed.
17. It is submitted, in para 39, that some findings of unsatisfactory professional conduct appear "almost inevitable". However, it is acknowledged, at this stage of the proceedings the Tribunal could not properly form a concluded view "as to important questions of judgment which go to the characterisation of the conduct as unsatisfactory professional conduct or professional misconduct". But it is submitted it could not be suggested that the Complaint is bound to "or even likely" to fail.
18. It is noted that, unlike some other cases where an order has been made under cl 12 of Schedule 5D to terminate an inquiry in circumstances where full and frank admissions of the asserted conduct have been made, the majority of the factual allegations are denied by the practitioner. Those matters which are admitted are asserted by the practitioner not to constitute unsatisfactory professional conduct.
19. It is submitted, at para 41, that there is a very real public interest in the proceedings being completed rather than "swept under the carpet". Reference is made to the remarks of Marks ADCJ in Health Care Complaints Commission v Mercurio [2017] NSWCATOD 136 of the importance of the Tribunal "not being seen to allow a health practitioner to avoid confronting allegations of serious misconduct unless there is a significant reason for doing so".
20. From para 42 to 44 the submissions address the question of the expense of the proceedings. It is submitted that, however onerous, the Tribunal is obliged to review the evidence and to make findings and notwithstanding any difficulty that task may involve is not a reason to terminate the proceedings. It is noted that in this case, unlike many other applications before the Tribunal under cl 2 of Schedule 5D, expense has already been incurred with the preparation of over 35 volumes of material and the practitioner relying on 13 volumes of material. It is also noted that the Tribunal has heard evidence from a number of lay witnesses and that the experts have prepared joint reports and have participated in joint conclaves. There have been 14 hearing days.
21. In summary, on the question of expense of continuation of the proceedings, it is submitted having regard to the considerable expense incurred to date, that it cannot be submitted that any saving of costs or resources of the Tribunal weighs in favour of the termination of the inquiry at this "extraordinarily late stage".
22. The submissions then address the extraordinary circumstances which face the Australian population as a result of COVID 19. It is submitted any delay occasioned by the virus is not out of proportion to the period of more than two years since the proceedings commenced. It is submitted that termination at this juncture of the proceeding would render "utterly futile" the significant resources already expended by all concerned, and that this cannot be in the public interest.
23. It is unnecessary that I repeat the submissions addressing the other criteria identified earlier in the HCCC's submissions other than to refer briefly to the issue of the practitioner's health. It is submitted that the submissions of the practitioner do not suggest that he is in a state of ill health that would preclude him from engaging in the practice of medicine in the future should he wish to do so. It is submitted that the practitioner's affidavit relied on in support of these proceedings does not suggest he is presently undergoing treatment for mental health issues. It is submitted that "this aspect of the public health is not relevant to the Tribunal's determination".
24. At para 52, the submissions address a number of matters raised in the practitioner's submissions which are directed to matters such as the overburdening of practitioners with excessive and unrealistic legal obligations, overburdening of doctors working in public hospitals, provision of services in a "real world" and matters of "fairness". It is submitted that each of these submissions should be rejected. Reference is made to the duties imposed on the HCCC by the National Law to refer complaints to the Tribunal.
25. The submissions next address the issue of "fairness" to the practitioner and submit the fact of his retirement is of no relevance. Rather, it is submitted that it is the Tribunal's role to protect the public from similar misconduct or incompetence of other practitioners, to uphold public confidence in the standards of the profession and to denounce, where appropriate, the conduct, by making an order under s 149C (4) of the National Law.
26. The submissions, at para 55, address the issue of the Parliamentary Select Committee Inquiry and the s 122 hearing. It is submitted that it is in the public interest for these proceedings to proceed to a conclusion, with all the allegations against the practitioner being fully ventilated in the forum the Parliament has determined as appropriate under the National Law to deal with professional disciplinary proceedings.
27. The submissions addressed to the public interest and cl 12 of Schedule 5D conclude by reference to the vulnerability of the cohort of the patients the subject of the Complaint and submit that "Public confidence in the standards of the profession militates strongly in favour of a substantive determination of the Complaint".
28. Paragraphs 59 to 80 of the HCCC's submissions address the practitioner's assertion that s 55 of the CAT Act may be applied and the proceedings dismissed under s 55 (1) (b) of that Act.
29. The submissions note, correctly, that s 55 of the CAT Act is found in Part 4 of the Act (the practice and procedure provisions). Reference is made to s 35 of the CAT Act and the decision of Sackville AJA with whom Basten JA and Beazley agreed in Medical Council v Lee [2017] NSWCA 282.
30. Having noted as a consequence of s 35 of the CAT Act, s 55 is subject to the National Law, it is submitted that cl 12 of Schedule 5D will prevail "to the extent of an inconsistency or repugnancy between that provision and s 55 of the CAT Act".
31. At para 63 it is submitted: Upon its proper construction, cl 12 of Schedule 5D of the National Law is intended to deal exhaustively with the circumstances in which the Tribunal may exercise its discretion to terminate an extant inquiry under the National Law
32. It is further submitted that cl 12 being the dominant provision identifies only three specific circumstances in which the discretion to terminate an inquiry or an appeal will be engaged. It is noted that s 55 of the CAT Act contains four separate and qualitatively different circumstances in which the Tribunal may exercise its discretion to dismiss proceedings. It is submitted that the articulation of the three specific criteria in cl 12 (1) (a) is inconsistent with the proposition that the more general criteria in s 55 of the CAT Act are intended to apply concurrently. It is submitted that, in order to exercise the discretion imposed by cl 12, the Tribunal must form an opinion on the question of "public interest" before it can determine to terminate an inquiry. It is asserted there is no equivalent or similar criteria in s 55 of the CAT Act.
33. In further support of the submission that s 55 of the CAT Act is inconsistent with or repugnant to the National Law, the HCCC submit that s 55 (1) (a) permits the Tribunal to make an order dismissing proceedings if the applicant withdraws the application. It is noted that no further criteria is imposed under s 55(1) (a). It is submitted "by contrast cl 12 of Schedule 5D of the National Law does not confer any discretion upon the Tribunal to terminate an inquiry simply because the complaint before the Tribunal is withdrawn". It is finally submitted that: It is inconceivable that a Tribunal conducting an inquiry under the National Law in which the subject complaint is withdrawn, could simply circumvent the public interest criterion in c 12 (1)(b) of Schedule 5D by opting instead to utilise the power of dismissal under s 55 of the CAT Act. It cannot do so because cl 12 of Schedule 5D of the National Law covers the field. Were the position otherwise, then cl 12 (1) (a) (iii) would have no work to do.
34. The submissions then address, in the alternative, why the proceedings should not be summarily dismissed under s 55 of the CAT Act.
35. The submissions cite a number of authorities of the appeal panel of the Tribunal setting out the correct construction of s 55 (1) (b) relative to each of the expressions found in that section namely "frivolous and vexatious", "misconceived" and "lacking in substance" .
36. It is noted, at para 74, that the practitioner asserts "without more" that the proceedings are "vexatious" and has not engaged in any consideration of the authorities on "vexatious" proceedings. It is suggested that the practitioner is in fact relying on the proceedings being "hopelessly misconceived".
37. In dealing with the submission made on behalf of the practitioner that the proceedings are "otherwise misconceived or lacking in substance" in the sense that the Complaint does not disclose a cause of action or is not reasonably arguable, it is submitted, at para 75, that the practitioner's submissions "contain a number of erroneous, incomplete or misleading characterisation of the evidence presently before the Tribunal". Having cited transcript references in respect of the oral evidence of Dr Stein, the submissions point out that the Tribunal has so far only heard "a small portion of the oral evidence from the expert witness".
38. The submissions point out that only Dr Stein has been cross-examined and that there has been no cross-examination of Professor Clarke or Professor Fox, and very little oral evidence from those witnesses. It is submitted that it is inappropriate for the practitioner to rely only on the limited evidence of Dr Stein as a basis for summary dismissal.
39. At para 77 it is submitted that the expert reports admitted into evidence are "fatal" to the practitioner's application and that the merits of the Complaint can only be considered after the cross-examination and re-examination of all the experts is completed.
40. The submissions are critical of the practitioner's reliance on "select and largely peripheral aspects of the joint reports". Finally, the submissions note that the practitioner's submissions do not "grapple with the ramifications of his own oral evidence before the Tribunal, and with the various concessions elicited from [the practitioner] in cross-examination".
41. Like Mr Graham, Ms Stern re-iterated and expanded the written submissions in her oral arguments. Ms Stern provided a number of transcript references in support of her oral submissions. I refer to these later in my consideration of the merits of the application.

The preliminary issue - the relevant standard of proof in disciplinary proceedings

1. In the submissions in reply the practitioner's counsel advance the proposition that, given the serious nature of the complaints, the standard of proof required is the criminal standard "beyond reasonable" doubt. The gravamen of this submission is that the proceedings are punitive, and designed to "denounce his [the practitioner's] transgressions". In the alternative, it is submitted on behalf of the practitioner that the standard is consistent with the principles espoused in Briginshaw (Briginshaw v Briginshaw (1938) 60 CLR 336) as explained by JRS Forbes in Justice in Tribunals.
2. In his oral submissions, Mr Graham submitted that disciplinary proceedings are neither wholly civil or wholly criminal, but are both. He referred to the decision of the High Court in Weaver v Law Society of NSW (1979) 142 CLR 201 at 207. I was also referred to the decision of Chief Executive Queensland Health v Jattan [2010] QSC 92 and [2010] QCA 359 at [16] as well as Rich v Australian Securities and Investment Commission [2004] 220 CLR 129 at [35] and the dissenting opinion of Elias CJ of the Supreme Court of New Zealand in Z v Dental Complaints Assessment Committee [2008] NZSC 55 at [54]. In the alternative to the criminal standard, it is submitted there is a "third test" in professional disciplinary proceedings as explained by the Full Court in Re Anderson v Medical Practitioners Act (1967) 85 WN NSW 558.
3. Ms Stern referred me to the HCCC's written opening submissions on the issue of the standard of proof, including reference to the decision of Polyglaze v Veterinary Practitioners of New South Wales [2009] NSWSC 347; Forster v Hunter New England Health Service [2010] NSWCCA 106 at [22]-[23] as well as Neat Holdings Pty Ltd v Karajan Holdings Pty Ltd [1992] 67 ALJR 70.
4. In the opening submissions filed on behalf of the HCCC it is submitted that the relevant standard of proof remains on the balance of probabilities and that the principles espoused in Briginshaw apply. The submissions go on to note: However, as the Full Federal Court noted in Sullivan v Civil Federation Authority (2014) 226 FCR 555 there is no principle of law that a Tribunal such as this is bound to apply the so-called Briginshaw standard to fact finding which is material to its reasoning process where those findings are grave or serious. Rather, a Tribunal such as this must appropriately inform itself "by reference to evidence or other materials which properly supports the seriousness of the findings being made and the seriousness of those findings on a party" (at [106]).
5. The submissions further note that "even as regards Briginshaw the Court of Criminal Appeal has cautioned against the use of "comfortably satisfied" as implying that proof to a higher standard than the balance of probabilities is required (see Gianoutsos v Glykis (2006) 65 NSWLR 539 at [547]-[549]).
6. First, I note that the principles referred to in Weaver while expressed to be generally applicable to professional disciplinary proceedings were made in the context of a solicitor who was found to have given deliberately false evidence in earlier disciplinary proceedings to the Supreme Court. In Weaver the Court of Appeal explained that disciplinary proceedings in the Supreme Court's inherent jurisdiction were "not criminal proceedings, they are proceedings sui generis". While aspects of disciplinary proceedings, or some disciplinary proceedings, may be akin to criminal proceedings, I do not read the comments in Weaver as establishing the principle that the criminal standard of proof should be the relevant standard of proof in all professional disciplinary proceedings.
7. Secondly, the discussion of Boddice J in the Court of Appeal in Queensland in Chief Executive Health v Jattan must be read in the context of the particular proceedings which involved issue of whether a notice, based on evidence given on compulsion under the Australian Crime Commission Act 2002 (Cth), could be relied on in proceedings. Those proceedings, which proposed the cancellation of an endorsement of the pharmacist under the relevant legislation, were found to be in the nature of a penalty. In this case the primary Judge was found to have relied on the High Court's decision in Rich v Australian Securities Commission. The decision in Chief Executive Health v Jattan does not however canvass the issue of the standard of proof.
8. Thirdly, I note the dissenting decision of Elias CJ in Z v Dental Complaints Assessment Committee was made against a factual background where the dentist had been acquitted in criminal proceedings of sexual abuse of patients while they were sedated. Elias CJ found in these circumstances the standard of proof should be the criminal standard and that the proceedings were an abuse of process.
9. It is clear that the plurality in the High Court in Rich, and McHugh J in his separate reasons, described the penalty provisions of the Corporations Law as having both a protective and punitive function. The plurality noted at [35] as follows: That it may be possible to characterise proceedings as having a purpose of protecting the public is not determinative. And to begin the inquiry from an a priori classification of proceedings as either protective or penal invites error. It invites error primarily because the classification adopted assumes mutual exclusivity of the categories chosen when they are not, and because the classification is itself unstable
10. I accept that many of the matters discussed in Rich, particularly in the reasons of McHugh J, highlight the similarities in reasons expressed by judges in respect of general deterrence and disqualification periods in proceedings for penalties under the Corporations Law to those of sentencing remarks of judges in criminal proceedings. I am, however, bound by longstanding authority that notwithstanding the punitive nature (cancellation of registration and disqualification), or general deterrence aspects of disciplinary proceedings the standard of proof is the civil standard as explained in the authorities relied by the HCCC. It is not the outcome of every disciplinary action that results in the penalty of cancellation or suspension of a practitioner's registration. As presently advised, I am satisfied that the authorities while acknowledging disciplinary proceedings may be akin to criminal proceedings do not support the proposition that the criminal standard of proof is applicable or that there is a third standard of proof. I also note that these proceedings, unlike disciplinary proceedings under the Legal Profession Uniform Law 2014 are not, save for exceptions set out s 67 of the CAT Act, subject to the requirements of the Evidence Act 1995 (NSW). It appears to me adherence to the principles espoused by the High Court in Neat Holdings Pty Ltd v Karajan Holdings Pty Ltd ensures the Tribunal has due regard for the gravity of the allegations in reaching its findings on the evidence.

What is "in the public interest"?

1. I commence my discussion of the question posed by consideration of three criteria. First, by consideration of relevant provisions of the Health Care Complaints Act 1993 (NSW) and the National Law. Secondly, by reference to the scope and purpose of protective orders which may be made at the conclusion of disciplinary proceedings under the National Law and thirdly to general principles derived from the case law.
2. Pursuant to s 90B of the Health Care Complaints Act 1993 (NSW) the Director of Proceedings is to determine whether a complaint about a registered health practitioner should be prosecuted before a disciplinary body. In so doing the Director is required to take into account the matters set out in s 90C. The matters in s 90C (1) (a) and (b) are clearly matters which engage consideration of the public interest.
3. Section 90C of the Health Care Complaints Act provides as follows: 90C Criteria relevant to determinations of Director of Proceedings (1) The Director of Proceedings is to take into account the following matters when making a determination as to whether or not a complaint should be prosecuted before a disciplinary body: (a) the protection of the health and safety of the public, (b) the seriousness of the alleged conduct the subject of the complaint, (c) the likelihood of proving the alleged conduct, (d) any submissions made under section 40 by the health practitioner concerned. (1A) When determining whether a complaint should be prosecuted by the Commission before a disciplinary body, the Director of Proceedings is to consider making a determination with respect to any associated complaint that has been referred to the Director of Proceedings (other than an associated complaint that is a complaint that has been discontinued or terminated and not reopened) so that the complaints are prosecuted concurrently. (2) For the purpose of enabling the Director of Proceedings to fulfil the Director's functions under this section in relation to a complaint referred to the Director, the Commission is to provide the Director with any submissions received under section 40 in relation to the complaint.

The National Law

1. There can be no doubt that the objects provisions of the National Law in the context of this application require consideration. I have earlier set out s 3 and s 3A. I am cognisant in dealing with any application under the National Law the health and safety of the public must be my paramount consideration.
2. Section 149D of the National Law requires the HCCC to refer a complaint to the Tribunal that may, if substantiated, provide grounds for the suspension or cancellation of a registered health practitioner's registration. It provides as follows: 145D Serious complaints must be referred to Tribunal [NSW] (1) Both a Council for a health profession and the Commission are under a duty to refer a complaint to the Tribunal if, at any time, either forms the opinion that it may, if substantiated, provide grounds for the suspension or cancellation of a registered health practitioner's or student's registration. (2) However, either the Council or the Commission may decide not to refer the complaint to the Tribunal if of the opinion the allegations on which the complaint is founded (and on which any other pending complaint against the registered health practitioner or student is founded) relate solely or principally to - (a) for a practitioner, the physical or mental capacity of the practitioner to practise the practitioner's profession; or (b) for a student, the physical or mental capacity of the student to undertake clinical training in the health profession in which the student is registered. (3) If the Council decides not to refer the complaint to the Tribunal, the Council must instead refer the complaint to a Committee or Impaired Registrants Panel. (4) If the Commission decides not to refer the complaint to the Tribunal, the Commission must instead refer the complaint to the Council. (5) This section does not require the Council or the Commission to refer a complaint the Council or Commission thinks is frivolous or vexatious.
3. The Tribunal is empowered under Subdivision 6 of Division 3 of Part 8 of the National Law, if it finds the subject matter of a complaint proved, or the practitioner admits the complaints, to exercise the remedies under s 149A (to caution, reprimand etc), s 149B to fine, or under s 149C, to suspend or cancel a practitioner's registration if that practitioner is not competent to practise, is guilty of professional misconduct, is guilty of a criminal offence the circumstances of which render the practitioner unfit in the public interest to practise the practitioner's profession, or the person is not a suitable person to be registered.
4. Section 149C (4) provides as follows: (4) If the person is no longer registered, the Tribunal may - (a) decide that if the person were still registered the Tribunal would have suspended or cancelled the person's registration; and (b) if the Tribunal would have cancelled the person's registration, decide that the person is disqualified from being registered in the health profession for a specified period or until specified conditions have been complied with; and (c) require the National Board with which the person was registered to record the fact that the Tribunal would have suspended or cancelled the person's registration in the National Register kept by the Board.
5. The words "public interest" are found in various provisions of the National Law including relevantly s 3, in association with a practitioner found guilty of criminal offences (s 149C), in determining whether to take action under s 150, in making an interlocutory order suspending a practitioner's registration (s 165L), in determining what information should be included in the public register (s 226), in requiring Committee members to put the public interest before the interests of a health professional in their determinations (Schedule 2), obligations on members of National Boards (Schedule 4) and in cl 12 of Schedule 5D.
6. The purpose of protective orders made in disciplinary proceedings is well-known. Meagher JA referred to the legislative scheme and the purpose of protective orders as follows in Health Care Complaints Commission v Do: The National Law establishes a registration and accreditation scheme. That scheme, by Div 3 of Pt 8, includes provisions for the making of complaints about registered health practitioners and the determination of those complaints, including in relation to serious complaints, by the Tribunal. The objectives of that scheme, as described in s 3(2), include to "provide for the protection of the public by ensuring that only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered" and to "facilitate access to services provided by health practitioners in accordance with the public interest". The provisions in Pt 8 concerning the making and dealing with of complaints are provisions substituted in the National Law by the Health Practitioner Regulation (Adoption of National Law) Act 2009 (NSW). Section 3A of the Law provides that in the exercise of those functions "the protection of the health and safety of the public must be the paramount consideration". Section 4, which applies to the National Law as in force in New South Wales, also requires that an entity having functions under it "is to exercise its functions having regard to the objectives and guiding principles" set out in s 3. The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It includes protecting the public from the similar misconduct or incompetence of other practitioners and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining those standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operates both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise.

Authorities considering public interest

1. In Hogan v Hinch [2011] HCA 4 the High Court discussed the words "public interest" in the context of s 42 of the Serious Sex Offenders Monitoring Act 2005 (Vic) in circumstances where it was asserted a journalist had breached a suppression order made by a trial Judge. French CJ explained: Section 42 requires that the court, before making an order under that section, be satisfied that "it is in the public interest to do so". The term "public interest" and its analogues have long informed judicial discretions and evaluative judgments at common law. Examples include the enforceability of covenants in restraint of trade[67], claims for the exclusion of evidence on grounds of public interest immunity[68], governmental claims for confidentiality at equity[69], the release from the implied obligation relating to the use of documents obtained in the course of proceedings[70], and in the application of the law of contempt[71]. When used in a statute, the term derives its content from "the subject matter and the scope and purpose" of the enactment in which it appears[72]. The court is not free to apply idiosyncratic notions of public interest. In exercising its powers under s 42, the court must assess public interest by reference to the place of the section in the statutory scheme, the purpose of the Act as a whole and the purposes of extended supervision orders. In determining whether to make a suppression order with respect to identification of an offender, the court must consider the extent, if any, to which the order would enhance the protection of the community. It must also consider its effect upon the offender's prospects of rehabilitation. Rehabilitation, if it can be achieved, is likely to be the most durable guarantor of community protection and is clearly in the public interest. A court considering such an order must also look to the larger constitutional and legal context which informs the interpretation of the statute, having regard to the effect of the order upon the open justice principle, on common law freedom of speech, and on the human rights guaranteed by the Charter. The application of a public interest criterion may require a balancing of competing interests and "be very much a question of fact and degree."[73] [footnotes omitted]
2. In the earlier case of O'Sullivan v Farrer (1989) 168 CLR 210 the High Court explained, when dealing with the words in the context of the granting of a liquor licencing statute, as follows: Indeed, the expression "in the public interest", when used in a statute, classically imports a discretionary value judgment to be made by reference to undefined factual matters, confined only "in so far as the subject matter and the scope and purpose of the statutory enactments may enable ... given reasons to be (pronounced) definitely extraneous to any objects the Indeed, the expression "in the public interest", when used in a statute, classically imports a discretionary value judgment to be made by reference to undefined factual matters, confined only "in so far as the subject matter and the scope and purpose of the statutory enactments may enable ... legislature could have had in view": Water Conservation and Irrigation Commission, per Dixon J. at p 505.
3. In McKinnon v Secretary, Department of Treasury (2006) 228 CLR 423 at [55] the High Court observed: It may readily be accepted that most questions about what is in "the public interest" will require consideration of a number of competing arguments about, or features or "facets" of, the public interest. As was pointed out in O'Sullivan v Farrer: "[T]he expression 'in the public interest', when used in a statute, classically imports a discretionary value judgment to be made by reference to undefined factual matters, confined only 'in so far as the subject matter and the scope and purpose of the statutory enactments may enable ... given reasons to be [pronounced] definitely extraneous to any objects the legislature could have had in view'." [footnotes omitted]
4. These principles were relied on in Duncan v Independent Commission Against Corruption [2016] NSWCA 143 at [226].
5. In Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91] Basten JA explained: The purpose of any order made upon a finding that a complaint has been proved, is said to be protective of the interests of the public at large, but more particularly patients or potential patients of the practitioner concerned. However, the public interests include, indirectly, the standing of the medical profession and the maintenance of public confidence in the high standards of medical practitioners. There is also an element of deterrence or, to put it more positively, encouragement to other practitioners to recognise the importance of complying with professional standards and the risks of failing to do so.
6. Also relevant to this matter is the decision of the Tribunal in Hill v Medical Council of NSW [2019] NSWCATOD 97. In this matter the Tribunal heard appeals under s 159 and s 159B of the National Law (against a decision of the Medical Council of NSW (the Council) suspending a doctor's registration). The Tribunal adopted the submissions made by the Council about the words "public interest" in the context of s 150. The Council's submissions on the topic of public interest were recorded by the Tribunal as follows: The Council argued that consideration of the public interest must involve consideration of matters which impact upon the honour and integrity of the medical profession generally. No actual harm needs to be demonstrated. The following passage from Crickitt v Medical Council of NSW (No 2) [2015] NSWCATOD 115 at paragraph 56 was cited: A consideration of the public interest will always include the need for patients to have confidence in the competence of medical practitioners and that medical practitioners will exhibit traits consistent with the honourable practice of an honourable profession. Integrity, trustworthiness and high moral and ethical values are an integral part of the practice of medicine, as is compliance with regulatory requirements and codes of practice established by those responsible for the administration of the medical profession. The public must have confidence that medical practitioners who treat them exhibit these traits. It was submitted that the scope and purpose of the legislation was the only confining factor in the interpretation of 'the public interest'. Our attention was drawn to Comalco Aluminium (Bell Bay) Ltd v O'Connor and Others (1995) 131 ALR 657, where Wilcox CJ and Keely J said, at p 681: The purpose of the reference to 'public interest' is to ensure that private interests are not the only matters taken into account: to make clear that the interests of the whole community are matters for the Commissioner's consideration. The effect of the reference is to amplify the 'scope and purpose' of the legislation. In Director of Public Prosecutions v Smith (1991) 1 VR 63, the Court said: The public interest is a term embracing matters, among others, of standards of human conduct and of the functioning of government and government instrumentalities tacitly accepted and acknowledged to be for the good order of society and for the well-being of its members. The interest is therefore the interest of the public as distinct from the interest of an individual or individuals.
7. I note that the adoption by the Tribunal in Hill v Medical Council of NSW of the authorities relied by the Council on the topic of public interest was in the context of proceedings under s 150 of the National Law. Although it may be argued that public interest connotations have a different focus given the nature of proceedings under s 150 to the instant proceedings, nevertheless I find those authorities emphasise a number of matters relevant to the scope and purpose of the legislation by which I must determine this application. Those factors include the high moral and ethical obligations on practitioners, the need to comply with regulations, and the confidence of the public in those who treat them. I find the remarks of Basten JA in Prakash v Health Care Complaints Commission very relevant to this application.
8. I accept that the scope and purpose of the legislation require that I consider s 3 (where relevant), s 3A and relevant provisions of Part 8 of the National Law. Inextricably intertwined with Part 8 are s 90B and s 90C of the Health Care Complaints Act.

Consideration

1. I find that it is appropriate that I weigh and balance the factors relevant to the exercise of my discretion to determine this application by first considering relevant matters under cl 12 of Schedule 5D of the National Law. I will thereafter consider whether that provision constitutes an exclusive code in dealing with when an extant Complaint before the Tribunal may be terminated, or whether an order can be made under s 55 (1)(b) of the CAT Act and the merits of that application, if available.

The seriousness of the alleged misconduct and the practitioner's denial thereof (or I would add, admissions made by the health professional)

1. The matters to be considered under this heading, in my view, go to the core of this application.
2. In making the findings necessary to determine this application, it is important that I note that I am not making concluded findings of fact on the evidence thus far adduced before the Tribunal. It must be remembered that, as noted by Basten JA in Prakash, the Tribunal is a specialist Tribunal whose constitution includes two medical professionals. Any concluded findings are those of the whole panel after hearing all of the evidence. My findings are limited to the identification and assessment of the strengths and weaknesses of matters relevant to public interest, or summary dismissal of the proceedings.

Evidence relevant to the prescription of 100mg carboplatin

1. I commence by reference to the Complaint. I adopt, for convenience, the framing of the Complaint using Patient M2 as an example, as this is the patient selected by the practitioner's counsel in the submissions. The Complaint alleges for this patient (and the majority of the other patients) that the practitioner engaged in instances of unsatisfactory professional conduct as specified in s 139 B (1) (a) and (l) of the National Law. It is further asserted that each particular relied on of itself justifies a finding of unsatisfactory professional conduct or when two or more particulars are taken together, they justify a finding of unsatisfactory professional conduct. Particular 1 is asserted as follows: The practitioner failed to provide appropriate care and treatment to Patient M2 in that he prescribed a flat dose, namely, a fixed dose administered regardless of the patient's characteristics ("flat dose") of 100mg carboplatin on six occasions between 30 June 2011 and 24 August 2011 inclusive, in circumstances where: (a) there was no published data supporting the use of a flat dose of 100mg Carboplatin; (b) a high evidence regimen such as treatment with Cisplatin was not contraindicated. (c) …
2. The parties are at issue about the gravamen of the multiple complaints about the practitioner. Mr Graham asserts that the case is all about the practitioner's asserted failure to comply with protocols (namely eviQ) and that the evidence underpinning the protocol in respect of prescribing carboplatin AUC2 is weak and has been superseded. He argues, as observed by the experts in their joint reports, that because of the absence of definite studies proving the efficacy of one treatment being superior to another that actual harm to a patient cannot be demonstrated. I note that the experts agree it is unlikely such studies will ever be conducted given the costs involved and other health priorities. Hence reliance on meta-analysis studies.
3. Ms Stern submits that the matter is more nuanced than advanced by Mr Graham. It is useful to understanding that position to refer to the HCCC's opening submissions. At para 12 the submissions describe the HCCC's case as follows: The Commission's case is, however, that there was no evidence to support the efficacy of the low dose of 100mg flat dose of Carboplatin as a radio-sensister but there was evidence to support the efficacy of higher doses (namely to support the efficacy of higher doses when compared to radiotherapy alone) see eg Budach et all [sic] meta-analysis January 2006; 1A/15(5)296. There is also meta-analysis, for example Pignon in 2009 in the Lancet: 1A/15 (a) and (b) supporting the benefits of chemotherapy in conjunction with radiotherapy for loco-regional control, and to a lesser extent, metastatic control. In those circumstances, it is not to the point that there was no evidence of an ineffective dose, and in the circumstances the method of obtaining consent outlined by the Respondent was grossly deficient. Further, the Commission says that the Respondent's apparent rationale for not using Cisplatin is not borne out for many of the patients, and that if Cisplatin was contraindicated, there was no basis in any event to use a regimen for which there is no evidence of efficacy.

The partial cross-examination of Dr Stein

1. The practitioner's submissions, both oral and written, place heavy emphasis on the evidence adduced from Dr Stein in his incomplete cross-examination.
2. Reliance is placed on Dr Stein's concession that a paper by Sandro Porceddu et al published in 2004 provided "low level evidence" (transcript 16 March 2020 p 751). This evidence was given after Dr Stein explained that: ..the Porceddu paper does not compare carboplatin with radiation versus radiation alone, it is an essentially a translation of the work that was done before using other schema, the milligram per metre squared scheme, and people basically translated the results from those papers, which did demonstrate a benefit, to a more modern prescription basis, that is, the AUC.
3. As noted in my summary of the practitioner's submissions about Dr Stein's evidence, reference is made to his evidence in which he agreed there is no direct evidence supporting the prescription of carboplatin AUC2 with radiation in the treatment of HNSCC. However, I note the following evidence: GRAHAM: In fact, without comparing patients receiving radiation with carboplatin AUC 2 with patients receiving radiotherapy alone, it cannot establish whether carboplatin at that dose is efficacious or not? WITNESS STEIN: Within - as exactly put to me, that is correct. However, there is a background there of the translation. So as put to me, yes, I agree with you, but there is that background that says there is data to support the use of carboplatin. Because otherwise we would have no data to support the use of carboplatin AUC. [Transcript 16 March 2020 p 752]
4. A major thrust of the practitioner's submissions is that the HCCC's case in respect of particular 1 (a) "falls away" because of the concession by Dr Stein that there is evidence which supports a flat dose of 100mg carboplatin.
5. This submission is based on replies given by Dr Stein in cross-examination about the opinion expressed in his report. Dr Stein opined that, based on studies by Kaur, Homma, Jeremic and Fountzilas, the practitioner's dose (of 100mg carboplatin x 6) was nowhere near two-thirds of the doses showing efficacy.
6. The following exchange occurred between Mr Graham and Dr Stein: GRAHAM: And if we just go to this right hand column on that page, the third paragraph that starts, "The treatment", you'll see the treatment schedule defined by the institute was used a daily dose of two and a half gray four times a week. And I must say, trying to work why it was 64 milligrams per square metre for the cisplatin puzzled me until I realised it was only on four days per week. So in this study, the cumulative dose of carboplatin was 400 milligrams per square metre, using an average BSA of 1.7, the cumulative dose received was 680 milligrams. Do you accept that? WITNESS STEIN: Yes. GRAHAM: So this study showed efficacy, to use your words, at a dose of 680 milligrams. Correct? WITNESS STEIN: Correct. GRAHAM: Now, without being too pedantic about it, that is essentially the same dose that Dr Grygiel prescribed cumulatively with his patients with carboplatin. Correct? WITNESS STEIN: Correct. GRAHAM: There is, we now see, published data showing that 600 milligrams, cumulative dose, has efficacy in the treatment of head and neck cancer. Correct? WITNESS STEIN: Correct. GRAHAM: It is false to assert that there is no published data supporting the prescription of cumulative dose of 600 milligrams, is there? Isn't that right? WITNESS STEIN: (No verbal reply) GRAHAM: Isn't that right? WITNESS STEIN: Correct.
7. I accept that, prima facie, this evidence appears to refute the assertion in particular 1 (a) of many of the individual complaints. Further support for Mr Graham's submission is derived from the second joint expert report where the experts note that taking renal function into account and converting to AUC doses or mg/m2 doses the dose [100mg carboplatin] does "overlap with the doses in early phase trials". The experts provide a number of caveats to this opinion namely that the trials involved a small number of patients, the aim of the trials was to assess tolerability of the treatment, and they did not directly compare chemoradiotherapy with radiotherapy alone.
8. I am conscious that the Tribunal has not had the benefit of hearing all the experts on this topic, nor has Dr Stein been afforded the opportunity for clarification, if any, of his evidence in re-examination. However, it is a matter to which, for the purposes of this application, I give some weight in favour of the practitioner's application. But I balance that factor against the HCCC's case as outlined by Ms Stern in her written opening in the substantive proceedings.
9. The practitioner's submissions refer to Dr Stein's evidence being misleading to the Tribunal. I am satisfied that the concession made by Dr Stein about an advantage between cisplatin and carboplatin must be considered in the overall context of the cross-examination. In his report Dr Stein relied on the findings in a report by Fountzilas (Fountazilas G, Ciuleanu E, Dafnu U et al , "Concomitant radiotherapy vs radiotherapy alone in patients with head and neck cancer", Med Oncol 2004;21(2):95-107). He agreed in cross-examination that he had put forward a difference that was not statistically significant, and acknowledged he was inaccurate because he should have indicated that "this was numerically different but not statistically and significantly different". It was in this context Dr Stein agreed his statement was misleading about an advantage between cisplatin and carboplatin "from that study".

The Joint Expert Reports

1. It is important in dealing with this application to bear in mind that these proceedings have reached a stage where all of the lay evidence has been adduced and the practitioner has given oral evidence in chief, been subject to lengthy cross-examination and has been re-examined. Prior to receipt of Professor Fox's evidence obtained by the practitioner's lawyers, Professor Clarke and Dr Stein met in conclave and produced a joint report. Professor Fox commented on that joint report. Subsequently Dr Stein prepared an additional report and a further joint report of all three experts was admitted into evidence.
2. As both parties acknowledge following the conclave a number of agreed statements of opinion were expressed by Dr Stein and Professor Clarke. The statements are important both in the context of the substantive proceedings and this application. The experts acknowledge: 1. That they do not think "there is evidence on the balance of probabilities to suggest that any patient was harmed by [the practitioner] in any centres in which he worked"; 2. That the practitioner "has probably the single greatest experience of any Australian Medical Oncologist after over twenty years of travelling to Bathurst and Orange clinics"; 3. They were "concerned that the use of guidelines alone should not be considered the standard way of prescribing chemotherapy, but rather they should be used as a treatment template that should be adjusted by a clinician based on their clinical experience, the clinical features of the patient and the circumstances of the treatment". They said "we thought compliance with guidelines should not be used as an indicator of treatment adequacy"; 4. Both experts agreed the treatment was "below the standard expected". They disagreed as to whether it was significantly below (Dr Stein's position) or simply below standard (Professor Clarke); 5. Patients were not treated according to standard protocols; 6. That treatment efficacy and toxicity need to be balanced; 7. That a number of patients who received 100mg flat dose carboplatin were cisplatin eligible; 8. That neither they, or any other oncologist, knows what is the optimal drug and/or schedule of chemoradiation; 9. The dose of carboplatin was unusual; 10. Taking renal function into account and converting to AUC doses or mg/m2 doses the dose does overlap with doses tested in early phase trials; 11. 100mg carboplatin chemoradiotherapy has not been directly demonstrated to be better than radiotherapy alone or to other doses of carboplatin in conjunction with radiotherapy.
3. Professor Clarke and Dr Stein disagreed about the reliance to be placed on outcome data, carboplatin vs cisplatin efficacy, whether carboplatin 100mg is acceptable as a standard or routine treatment offered to a significant portion of patients. Professor Clarke opined this aspect of prescribing was below standard, but not significantly below.
4. Following the conclave of all three experts a further joint report was prepared.
5. While Professor Fox agreed with a number of the opinions earlier expressed by Professor Clarke, all experts agreed that if the practitioner wished to evaluate different schedules of treatment, this would have been better done in a clinical trial. Significantly, all experts agreed the treatment was below standard, however Professor Clarke opined that he considered it to be not significantly below standard because of the generally favourable outcomes of patients treated, and because some of the treatments especially carboplatin and radiotherapy had been subject of clinical trials in similar doses and the fact that "many aspects of the practice were similar to multiple other practitioners he had worked with/and or observed during practice at multiple sites in Sydney". Professor Fox generally agreed with Professor Clarke but further stated he found the "general benefit of adjuvant chemo added to radiotherapy to be of very dubious benefit given the significant toxicity".
6. All experts agreed that both treatment efficacy and risk of toxicity need to be considered and balanced. All experts agreed on the need for direct patient evaluation including clinical judgment to adjust dose to individual circumstances. Secondly, they agree "if a priori dose reductions are being made to reduce toxicity their impact on efficacy must be considered" and thirdly, "if there were a significant risk of reduced efficacy they would expect this to be discussed with the patient and where possible and appropriate that evidence of the discussion should be available in medical records and patient letters while noting the ability to do this may be negatively impacted by the use of Oncology Management Information Systems".
7. The further joint report emphasised if the treatment had occurred in a formally approved phase 11 trial, there would have been no objection. In commenting on the opinions expressed in the Joint Expert Report, including that the dose of carboplatin was unusual, Professor Fox is recorded as saying he "agrees with this with the exception of the flat dose section; he is of the opinion that the means for the choice of these regimens is unclear apart from the avoidance of toxicity".
8. Of significance is the fact that all experts agreed that the practitioner should have used AUC dosing to "standardize exposure to drug, and that doing so was below the standard expected". Further Professor Clarke expressed his concern relating, not to underdosing, but "rather the potential for overdose in patients with severe renal impairment such as a dialysis patient".

The practitioner's oral evidence

1. In her oral submissions, Ms Stern directed me to the practitioner's evidence including his evidence that for HNSCC patients he should have prescribed cisplatin unless it was contraindicated [Transcript p 370], that cisplatin was the "gold standard" and that the weight of the evidence in terms of trials were dominated by cisplatin rather than carboplatin [Transcript p 454]. Ms Stern also referred to the practitioner's evidence that there is more evidence in support of cisplatin being efficacious as compared to carboplatin [Transcript p 454]. Reference is also made by Ms Stern to the practitioner's evidence which was that in 2016, cisplatin was the better drug based on the Pignon meta-analysis [Transcript p 454].
2. I observe that all experts agree 17 of the patients the subject of the complaint were "cisplatin eligible". I find, for the purposes of assessing the seriousness of the prescribing complaints that, at this stage of the proceedings, the evidence raises issues yet to be resolved after the cross-examination of all experts as to whether the prescribing of a flat dose of 100mg carboplatin, particularly for patients who were cisplatin eligible, was significantly below the standard, noting it is agreed by all experts the prescribing generally was below standard. That important issue can only be resolved by the findings of the whole panel, including in particular, the medical experts, based on the completed evidence and in particular consideration of each individual patient's circumstances. Thus, while particular 1(a) of many of the individual complaints may not be established, that does not necessarily mean that the prescribing complaints will or will not be established.
3. I have not ignored or failed to give weight to the fact the practitioner's prescribing was considered as part of the s 122 inquiry and by a Parliamentary Select Committee. I note that the report of the latter inquiry is not in evidence before us. However, those inquiries were not exclusively focussed, as are these proceedings, on particular patients and their treatment. Nor have I ignored in my assessment the matters on which the experts are agreed or whether the evidence will or will not ultimately establish conduct significantly below the expected standard or improper or unethical conduct. If the conduct particularised does constitute unsatisfactory professional conduct or professional misconduct it is likely the findings will be relevant to specific deterrence and to general deterrence. This is an important consideration in this application.

Informed consent issues

1. I commenced this aspect of my consideration noting that the Tribunal has heard the evidence of seven patients who were required for cross-examination and in particular on the topic of their discussion with the practitioner about the treatment he proposed and their consent or purported consent to it.

Joint Expert Reports

1. The experts are divided in their opinion about the issue of consent. Professor Clarke and Professor Fox found the practitioner's conduct in respect of consent was below standard, but not significantly below standard. Professor Fox added a "rider" about the inability for the consent process to be understood due to lack of documentation.
2. As noted in the HCCC's submissions, all the experts agreed that "consent is a real and substantive issue, and identified that adequate discussions would have ameliorated their concerns". Reference is also made to the fact the practitioner admitted that he was not aware of any other oncologist in Australia at the relevant time who was prescribed a flat 100mg dose of carboplatin.

The practitioner's evidence and submissions

1. The practitioner gave evidence that he told patients they would receive a low dose of chemotherapy. In his cross-examination the practitioner explained: that there would be one or two times that somebody may pick up on the issue of low and that would bring up the idea of there being another dose and at which case you would, for those particular patients, talk about eviQ protocol and - and discuss the idea that the doses for the eviQ protocol were going to be higher than the 100mg flat dose, and they they said "Which one would you recommend doctor?" and you would explain that on the basis of efficacy and toxicity that I would recommend the hundred-milligram [transcript 9 August 2019 p 487].
2. In respect of some patients, the practitioner said he had a clear recollection of discussion with the patient.
3. As noted above, the practitioner's submissions argue, firstly, that it is unnecessary to pursue this aspect of the Complaint as a precedent or deterrent to other practitioners as there are many authorities dealing with informed consent. I find that submission, which is broadly framed, is unconvincing in the circumstances of this matter. The issue of consent is raised for many of the patients, particularly the St Vincent's cohort, in the context of treatment in a multi-disciplinary team environment, or in the circumstances of the Western NSW Local Health District patients of a "fly in fly out service". Regardless of where the treatment occurred, all of the patients were facing making a decision about a treatment regimen in the context of a very serious diagnosis with a possible adverse outcome. Thus, there are unique features surrounding the obtaining of consent in this matter which can only properly be explored by the panel at the conclusion of the evidence. While other decisions have considered issues relevant to informed consent, I do not find "a one size fits all" can be applied in the particular circumstances of this case.
4. The second basis on which it is argued that it is unnecessary for the matter to proceed on the issue of the patient's consent is the argument that it was unreasonable to have expected the practitioner to have gone into detail about the chemotherapy drugs and their efficacy in circumstances where the prescribing complaint is without merit. In short, the argument is that it could not be reasonable for the practitioner to provide information about a protocol (eviQ) which had insufficient evidence to support it. In his oral submissions. Mr Graham drew an analogy with a patient suffering pneumonia and submitted it would be unrealistic for a doctor to have to tell a patient he or she could prescribe one of four types of antibiotics. Professor Clarke in his report gives some support to this argument noting that most patients are content to rely on the expertise of the oncologist and that the consent process was in line with practice at the relevant time. That is a matter which must be weighed having regard to all the evidence, including, in particular, the evidence of the practitioner about how he responded to the few patients who "picked up" and asked what was meant by a "low dose".
5. The third basis on which it is submitted that it is unnecessary to pursue the consent issue is that little weight could be given to the patients' evidence about the consent process in light of the fact their evidence post-dates the provision of information to them that they received a low or inadequate dose of chemotherapy. Two matters have bearing on that submission. First, it must be remembered that the forensic decision was made on behalf of the practitioner to cross-examine a number patients on their affidavits. It appears to me in those circumstances the evaluation of the credibility of the evidence of those patients and that of the practitioner is a matter of weight for the whole Tribunal. It must be remembered that these proceedings have their genesis in complaints made to the HCCC by a number of patients, and that after investigation by the HCCC the Director of Proceedings determined the proceedings should be instituted. There is a public interest aspect which supports these patients knowing the outcome of their complaints.
6. Consistent with my finding that the prescribing complaint raises issues wider than the eviQ protocol for the administration of carboplatin, I am satisfied that the level and/or adequacy of explanation provided to the patients is an important matter with a significant public interest focus.
7. Thus, I conclude, on balance, that the factors relevant to the "informed consent" issue outweigh the matters agitated on behalf of the practitioner and support it being in the public interest for the proceedings to be completed.

Record keeping issues

1. This aspect of the proceedings is not a pivotal issue in respect of this application. However, it does overlap to a substantial degree with the issues relating to the patients' consent to their treatment.

The practitioner's evidence and submissions

1. The practitioner denies the record keeping allegations. The submissions address the record keeping allegation and assert there is no obligation in the record keeping regulation or consent policies which requires that an annotation be made to a consent form. It is not in dispute that in many instances the only evidence in the records of the patient's consent is their signature on a "pro forma" consent form which states "carboplatin", and in some instances, this form is one completed by the Registrar. There is some evidence in correspondence from the practitioner to other members of the multi-disciplinary team at St Vincent's about his exact proposed chemotherapy regimen for patients who are not the subject of the complaint.
2. I also note that the HCCC dispute the assertion in submissions of the practitioner that the patients' records are incomplete, except for records for the Western NSW Local Health District cohort of patients. I accept that the HCCC is bound by the model litigant provisions. In these circumstances, and although provision of some of the medical records has been piecemeal, l accept that except for the Orange and/or Bathurst patients that the records are complete.

The Joint Expert reports

1. The second joint expert report discloses that both Dr Stein and Professor Fox opine that the practitioner's record keeping is significantly below the standard. They do not directly address whether the records are in breach of the regulation.

Consideration - the record keeping complaint

1. As noted above, I do not find in the overall context of this application, which requires some assessment of the weight to be given to asserted serious errors of clinical skill and judgment as well as consent issues that the record keeping issue of itself can be determinative of whether it is in the public interest for these proceedings to continue. However, as part of the overall matrix, I accept there are public interest considerations in ensuring medical records are compliant with regulations, and the nature and extent of those obligations in the context of public and private hospital records is important.

Conclusions - the seriousness of the alleged misconduct, consent and record keeping

1. It is important to remember that significant time has been invested in these proceedings to date, including particularly the lengthy cross-examination of the practitioner and preparation of extensive reports, expert conclaves and joint expert reports. While not determinative of the application, the time and effort expended on the proceedings to date does require consideration. The prescribing complaints raise issues of the extent to which reliance can or should be placed on the published research and in particular the evidence of the experts on that research.
2. On balance, I am satisfied that for the reasons discussed above in relation to prescribing issues, and particularly in respect of informed consent and documentation, that it is in the public interest for the substantive proceedings to be completed.

The expense likely to be incurred, the demands on the resources of the Tribunal and the delay occasioned if an inquiry proceeded

1. Both parties acknowledge that these proceedings have been expensive and have placed demands on the resources of the Tribunal. I accept that to be the case. I accept the proceedings have also placed significant demands on the parties and they have incurred considerable expenses. The practitioner suggests in his submissions that a further two weeks will be required to complete this matter. Counsel for the HCCC has indicated that the matter could be completed with a further five hearing days and written, rather than oral, submissions at the conclusion of the evidence.
2. I am very conscious of the monetary costs which have been incurred to date in these proceedings as well as the emotional cost to the practitioner. It is a matter of considerable concern to me that the proceedings initially had to go over part-heard and have now been temporarily adjourned in the extraordinary circumstances wrought by the COVID 19 pandemic.
3. I do not find that the proceedings are being maintained by the HCCC in order to obtain a costs order at the conclusion of the proceedings. I note, as mentioned earlier, that the HCCC must act as a model litigant in proceedings and not maintain proceedings for an improper purpose.
4. In a number of the cases determined under cl 12 of Schedule 5D the Tribunal has, as one only of the factors taken into consideration in the public interest, the costs to the Tribunal, the indirect costs to the public and the parties. However, those cases turn on their own particular facts. In many cases the practitioner concerned has admitted the particulars of the Complaint, or the Director of Proceedings has determined it is not appropriate for a case to continue. This matter is not on "all fours" with such decisions. The practitioner does not admit or denies the majority of the individual complaints, and strenuously advocates he has always acted in his patients' best interests.
5. While I give some weight to the delay and ongoing costs which will be involved if the proceedings are not terminated I do not find this factor to be of such significance in the public interest that it can be determinative of the proceedings.

That the practitioner has voluntarily surrendered registration and undertaken on oath not to seek registration

1. In this case I accept that the practitioner has now surrendered his registration and has undertaken on oath not to seek registration. I do not place any significant weight on the submission that this did not occur until this application was made. First, the practitioner changed his registration from practising to non-practising status prior to the commencement of the proceedings. Secondly, he has not practised since he left St Vincent's following the publication of the 7.30 Report in February 2016.
2. While the HCCC submit he could seek to practise again, I find it is highly improbable he will do so. In reaching this conclusion I note the period of time he has had out of the practice of medicine, his age (74 years) and his stated intention not to resume practice.
3. It follows that I find the practitioner is not likely to present a direct risk to the health and safety of the public by engaging in the practice of medicine. Thus, the factors supporting the continuation of the proceedings must be matters of specific and general deterrence, the upholding of the standards of the profession and confidence in it. These aspects of the proceedings have been considered by me in my assessment of the seriousness of the complaints.

Any determination by the Commission with the agreement of the Medical Council not to proceed with the prosecution of the complaints

1. The position of the HCCC is clear. The Director of Proceedings does not consent to the termination of the proceedings.

The impecuniosity of the practitioner

1. As noted earlier in these reasons, although the submissions in reply on behalf of the practitioner submit that he may not be covered by his professional indemnity insurer for the costs of these proceedings, there is simply no admissible evidence before me on that topic or the financial position of the practitioner. The submission is speculative. I have not placed any weight on it.

The ill health of the practitioner which would preclude him or her from engaging in further practice

1. It is convenient that under this heading I consider both the health of the practitioner, further delay of the proceedings and the consequent impact on the practitioner's health. I commence by noting the practitioner has not adduced any corroborative evidence about his health, his treatment for depression by a psychiatrist or from his general practitioner. I note that it is the practitioner who carries the onus of proof in this application.
2. The practitioner in his affidavit deposes to the stress he is suffered since the 7.30 Report, and the adverse impact on his family of media attention, and the subsequent inquiries and court proceedings. I am exquisitely conscious of the effect of the stress of disciplinary proceedings on any practitioner, and in particular, for this practitioner in the tragic circumstances of the death of his wife and unavoidable delays in the proceedings. I am conscious that through no fault of the practitioner, these proceedings could not be concluded in the time originally allocated for the hearing, and that the impact COVID 19 pandemic has caused further delay. I very much regret these delays have occurred and I have sympathy for the practitioner and his family in these circumstances.
3. I accept delay in the conclusion of the proceedings is a relevant consideration. However, I am satisfied that this matter can, and will, be given priority in Tribunal listings if the only satisfactory way it can be concluded affording procedural fairness to both parties is by a face to face hearing in the "normal" manner. The Tribunal will continue to explore whether the matter can be resolved using technology but noting the limitations when a hearing involves the Tribunal panel of four members, and the parties' firm view that the experts should give their evidence concurrently.
4. I accept the practitioner's evidence that he has suffered depression and he and his family have been impacted by media attention. As previously recorded, I find that it is highly improbable that the practitioner will seek to practise again. However, as I am satisfied that fact does not go to the heart of this application I have not given significant weight to this factor.
5. The practitioner's submissions summarised earlier in these reasons address the objects provisions of the National Law and refer to the proceedings being "unfair" to the practitioner, that regard must be had to "real world" conditions in a busy public hospital settings. I have considered these factors, but find the seriousness of the complaints, and informed consent issues mean that the proceedings should not be terminated on the basis of unfairness. In saying this, I fully accept that the proceedings must be conducted in a procedurally fair manner as required by the National Law.

Conclusions Clause 12 Schedule 5D

1. In summary, I accept the submission that the practitioner does not now or is not likely in the future to present a risk to the health and safety of the public. I am further satisfied that he has been emotionally adversely affected by matters including adverse publicity, the need to institute court proceedings and necessary appearances at the Parliamentary Inquiry and the s 122 proceedings as well as these proceedings. I accept, through no fault of the practitioner, the timely conclusion of these proceedings has not to date occurred. I also accept that on the current state of the evidence that, prima facie, there is some published data supporting a total dose of carboplatin of approximately the same dosage as that prescribed by the practitioner to many of the patients. I have also taken into account in considering this application that all experts agree that there is no evidence which demonstrates any patient was harmed by the practitioner's prescribing.
2. However, the matters in my answers to the identified topics, indicate the complaints raise serious issues for determination. These complaints involve 17 patients in respect of whom all experts agree were cisplatin eligible, issues relating to informed consent and recording of that consent in a multi-disciplinary setting or in the context of a fly in fly out service. Matters relating to the practitioner's circumstances must be balanced against the need for resolution of complaints made by patients and appropriate findings on the evidence of patients, in particular, those required for cross-examination. Resolution of the proceedings may result in important findings in respect of specific and general deterrence, and upholding of the standards of the profession. While aspects of matters supporting termination and those for rejecting the application are, in many respects, finely balanced, overall I conclude it is in the public interest for the proceedings to continue to finality and for the application under cl 12 of Schedule 5D to be dismissed.

The relevant statutory provisions

1. I have earlier in these reasons made reference to s 35 of the CAT Act and set out s 55 of that Act. Both provisions are found in Part 4, the part of the Act dealing with Practice and Procedure.
2. I have also set out the provisions of cl 12 of Schedule 5D. Schedule 5D is headed "Proceedings before Professional Standards Committees or the Tribunal" and is a NSW provision.
3. Clause 12 provides that the Tribunal may decide (a) not to conduct an inquiry or (b) at any time to terminate an inquiry or an appeal if any one of three circumstances apply and if the Tribunal forms the opinion it is not in the public interest for the inquiry or appeal to continue. Section 90C (1A) supports the proposition that a complaint which has been terminated may be re-opened.
4. Section 55 of the CAT Act empowers the Tribunal to dismiss proceedings in certain circumstances. Section 55 (2) provides the Tribunal may re-instate proceedings dismissed under s 55 (1) (c) because the applicant or appellant failed to appear, if the Tribunal considers there is a reasonable explanation for the failure.
5. The Macquarie Dictionary defines the word "terminate" as follows: -verb (t) 1. bring to an end; put an end to. 2. to occur at or form the conclusion of. 3. to bound or limit spatially; form or be situated at the extremity of.
6. The word "dismiss" is defined as follows: 9. Law to put out of court, as a complaint or appeal.

The effect of principles enunciated in Medical Council v Lee

1. On behalf of the HCCC it is submitted, having regard to the principles espoused by Sackville AJA, with whom Beazley P and Basten JA agreed, that cl 12 "is intended to deal exhaustively with the circumstances in which the Tribunal may exercise its discretion to terminate an extant inquiry under the National Law." It is submitted the provision is the "dominant" provision.
2. In Medical Council v Lee [2017] NSWCA 282 Sackville AJA explained at [87]-[94] as follows: When used to defined the relationship between two statutes or provisions, "subject to" is a standard means of establishing which provisions are dominant and which are subservient.[29] The subservient provisions therefore operate only to the extent that they are not inconsistent with or repugnant to the dominant provisions.[30] In C & J Clark Ltd v Inland Revenue Commissioners,[31] for example, the relevant subsection commenced with the words "subject to the provisions of this section". Megarry J said that:[32] "the phrase 'subject to' is a simple provision which merely subjects the provisions of the subject subsections to the provisions of the master subsections. Where there is no clash, the phrase does nothing: if there is collision, the phrase shows what is to prevail. The phrase provides no warranty of universal collision." In my view, this is the meaning that should be given to s 35 of the NCAT Act. Thus to the extent that there is an inconsistency or repugnancy between a provision of Part 4 of the NCAT Act and the National Law [NSW] (or any other "enabling legislation), the National Law [NSW] governs. Whether there is an inconsistency or repugnancy depends on the proper interpretation of the relevant provisions of the National Law [NSW]. For present purposes it is necessary to consider whether there is any inconsistency or repugnancy between s 43(3) of the NCAT Act and the relevant provisions of the National Law [NSW]. The inconsistency might take the form of a direct conflict between two provisions (for example, where both cannot be obeyed simultaneously). There will also be an inconsistency in the relevant sense if, as a matter of construction, the National Law [NSW] is intended to operate in relation to a particular matter to the exclusion of s 43(3) of the NCAT Act.[33] … Fourthly, the National Law [NSW] contains elaborate provisions relating to health practitioners, including medical practitioners. The legislation contains apparently comprehensive provisions dealing with accreditation and registration of health practitioners, complaint and disciplinary procedures and powers, performance assessment, investigation of impairment concerns and many other issues. It is true that the National Law [NSW] substantially modifies the national model legislation. But if anything the "NSW provisions" (as they are described in the legislation) support the proposition that the National Law [NSW] is intended to deal comprehensively with the matters it addresses.
3. It is submitted on behalf of the HCCC that the clause identifies three specific circumstances in which the discretion to terminate an appeal may be engaged and that the engagement of these specific circumstances is inconsistent with the proposition that the more general requirements in s 55 are intended to apply concurrently. By way of example reference is made to the power of the Tribunal under the CAT Act to dismiss proceedings if the applicant withdraws the application and cl 12 (1) (iii) which, in addition to withdrawal, requires consideration of whether the withdrawal is in the public interest.
4. I accept the soundness of the HCCC's submission. I am satisfied that in the circumstances of this extant complaint the power to terminate the proceedings is to be considered solely under cl 12 of Schedule 5D of the National Law.
5. It may be that different considerations apply if an appeal is lodged in the Tribunal where the Tribunal has no jurisdiction under the National Law, or an applicant is subject to an order under the Vexatious Proceedings Act 2008 (NSW). In these circumstances the use of s 55 by the Tribunal to control its processes may be applicable. A further relevant distinction between the provisions may be the fact that if the proceedings are dismissed under s 55 of the CAT Act they are at an end (subject to the limited circumstances in s 55 (2)) whereas if a Tribunal determines to terminate an inquiry, the Health Care Complaints Act contemplates a terminated complaint may be re-opened.

Are the proceedings "frivolous or vexatious" or otherwise misconceived or lacking in substance?

1. In the event I am wrong in my determination that in the circumstances of an extant inquiry under the National Law that cl 12 of Schedule 5D covers the field, I now consider whether the proceedings are frivolous or vexatious or otherwise misconceived or lacking in substance.
2. I have earlier referred to the practitioner's submissions on this topic. The HCCC's submissions refer to decisions of the Appeal Panel of the Tribunal and the Court of Appeal that address the criteria for summary dismissal on the basis that the proceedings are frivolous or vexatious, or misconceived (if based on a misunderstanding of a legal principle or fail to disclose a cause of action, or are lacking in substance being based upon an untenable proposition in fact or law or are not reasonably arguable). It is noted that the practitioner's submissions fail to address the authorities on "frivolous and vexatious".
3. I note that the submissions made on behalf of the practitioner are that the proceedings are vexatious. It appears to me that submission is based on the proposition that the proceedings are being pursued somehow inappropriately by the HCCC. I do not accept that to be the case.
4. The gravamen of the submissions made on behalf of the practitioner under s 55 appears to me to be directed to the submissions directed to the evidence adduced from Dr Stein in the course of his incomplete cross-examination. Bearing in mind the principles applicable to summary dismissal, and noting that the Tribunal has not yet had the benefit of all of the evidence of the expert witnesses, for reasons elucidated earlier in these reasons in respect of the seriousness of the complaints I could not be satisfied on the current state of the evidence taken at its highest that the Complaint is doomed to fail (see Tebb v State of NSW [2020 NSWCATAP 85). Thus, I conclude the proceedings should not be dismissed under s 55 (1) (b).

ORDERS 1. The application under c 12 of Schedule 5D of the Health Practitioner Regulation National Law is dismissed. 2. The application under s 55 (1) (b) of the Civil and Administrative Tribunal Act 2013 (NSW) is dismissed. 3. The matter is listed for directions to fix adjourned hearing dates on a date and at time to be notified by the Registrar, Occupational Division, NCAT.

I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales. Registrar DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 13 May 2020