WILLIAMS v A PROFESSIONAL CONDUCT COMMITTEE OF THE MEDICAL COUNCIL [2018] NZHC 2472

WILLIAMS v A PROFESSIONAL CONDUCT COMMITTEE OF THE MEDICAL COUNCIL [2018] NZHC2472 [20 September 2018]IN THE HIGH COURT OF NEW ZEALANDAUCKLAND REGISTRYI TE KŌTI MATUA O AOTEAROATĀMAKI MAKAURAU ROHECIV-2017-404-002113[2018] NZHC 2472IN THE MATTER OF an appeal pursuant to s 106(2) of the HealthPractitioners Competence Assurance Act2003BETWEEN JOSEPH WILLIAMSAppellantAND A PROFESSIONAL CONDUCTCOMMITTEE OF THE MEDICALCOUNCILRespondentHearing: 21 August 2018Appearances: A H Waalkens QC and A Holloway for AppellantA K Miller and B Johns for RespondentJudgment: 20 September 2018JUDGMENT OF WYLIE JThis judgment was delivered by Justice WylieOn 20 September 2018 at 4.00 pmPursuant to r 11.5 of the High Court RulesRegistrar/Deputy RegistrarDate:Solicitors/counsel:DLA Piper/A H Waalkens QC, AucklandClaro, WellingtonIntroduction[1] The appellant, Dr Williams, appeals against a decision of the HealthPractitioners Disciplinary Tribunal (the Tribunal) dated 1 September 2017, whichfound him guilty of two charges of professional misconduct, censured him, fined him$10,000, imposed conditions on his continued practice and ordered him to pay$145,000 in costs.1[2] Dr Williams appeals the Tribunal's finding of professional misconduct andseeks to quash that determination. In the alternative, he appeals that part of thedecision which imposed the $10,000 fine and seeks to quash that fine.[3] The respondent, the Professional Conduct Committee (the PCC), opposes theappeal and argues that the Tribunal's decision was correct.Factual background[4] Dr Williams is a general practitioner – based in Auckland. He has some 38years' experience in that capacity. Over the years, he has developed a specialistinterest in the treatment and management of patients with eczema. He published abook on the topic in February 2014 which has sold nearly 3,000 copies.[5] Eczema is a chronic inflammatory disease affecting about 30 per cent of NewZealand children. It appears before the age of five years in approximately 90 per centof those who suffer from it; 60 per cent of sufferers experience it before turning oneyear old. The disease is distressing for those affected and it imposes considerable costson the health system. Its treatment is complex and multifaceted, but it is commonlyaccepted that a core component of therapy is to manage the inflammation with topicalcorticosteroids.[6] In about 1963, Dr Williams and a chemist developed what Dr Williamsbelieves is an effective treatment for eczema. It is a compound (or mix) of two creams.One cream is a topical corticosteroid (betamethasone valerate 0.1%) and the other isan anti-fungal cream (clomazol 1%). They are mixed together in one of three different1 Professional Conduct Committee v Williams HPDT 909/Med16/371P, 1 September 2017.strengths or ratios. Dr Williams calls this compound product "betaclom". He claimsto have successfully used betaclom for some years; indeed, he estimates that some47,300 patients have been treated with betaclom, all without complaint or issue. Hesays that many of those patients specifically sought him out because they had becomedissatisfied with the care they were receiving from others and because they werelooking for a change in their treatment regimes.[7] In recent years, other medical professionals have become concerned aboutDr Williams' use of steroids to treat skin conditions and various complaints have beenmade to Dr Williams or to the appropriate medical authorities. Complaints fromfellow medical practitioners started in August 2011 and they have been madeintermittently since.2[8] In June 2014, the Medical Council of New Zealand issued a notice of risk ofharm under s 35 of the Health Practitioners Competence Assurance Act 2003 (the Act)relating to Dr Williams prescribing betaclom for use on children.[9] Dr Williams' conduct in prescribing betaclom to various patients was referredto the PCC for investigation and, on 29 September 2016, it laid a disciplinary chargebefore the Tribunal alleging that Dr Williams had acted in a manner amounting toprofessional misconduct under either s 100(1)(a) and/or (b) of the Act. The chargewas amended and an additional charge was laid in May 2017. An anonymised copyof the charges is annexed to this decision. They came before the Tribunal for hearingover eight days in July/August 2017.Two decisions[10] The Tribunal has issued two decisions – both covering much the same ground.First, it issued an oral decision on the last day of the hearing – 10 August 2017. Thatdecision was later transcribed. It runs to some 15 pages. It is more than a "resultsjudgment". The Tribunal then issued another more fulsome decision in writing on 1September 2017.32 Details of the complaints alleged by the PCC are in the schedules forming part of the chargeswhich are annexed to this judgment.3 Professional Conduct Committee v Williams, above n 1.[11] This procedure strikes me as unusual and fraught with risk. Fortunately, it isnot suggested in this case that there is any material conflict between the two decisions.The parties' submissions before me largely focussed on the 1 September 2017 decisionand, unless expressly noted, this judgment refers to that decision.The Tribunal's decision of 1 September 2017[12] The Tribunal summarised the relevant factual background, noting, inter alia,Dr Williams' special interest in the treatment of eczema. It observed that he is ageneral practitioner and that his conduct fell to be judged accordingly. It referred toDr Williams' practice of combining betamethasone valerate and clomazol andproviding this compound to his patients for use by them. It noted that, at consultation,Dr Williams described how the betaclom should be applied and handed a guide sheetentitled "ECZEMA CARE – MANAGEMENT GUIDE SHEET" to his patients or totheir parents. The guide sheet included the following advice:YOUR CREAM – this is our low dose steroid/anti-fungus eczema cream– (It is not a moisturiser)Apply twice daily to affected areas.On the reverse side, there was a flowchart detailing the application process, whichincluded the following:Apply Beta/clom cream 2 x daily on affected eczemaskin only – (not on normal skin)Apply enough cream – not sparinglyFor eczema skin[13] The Tribunal then considered the charges and the relevant legal tests it wasrequired to apply. It noted that the onus of proving the charges lay on the PCC, on thebalance of probabilities, and that the more serious the allegation, the higher the levelof proof required.[14] The Tribunal then considered the nature of betamethasone valerate, referringto the evidence presented to it. It observed that betamethasone valerate is an activetopical corticosteroid, but it did not make any express finding as to its potency. It thenconsidered clomazol. Inter alia, it was alleged by the PCC that Dr Williams hadprescribed clomazol in circumstances where the prescription was not clinicallyjustified. The Tribunal noted that this particular of the charge (repeated in respect ofa number of patients) was not pressed by the PCC, other than in the context ofclomazol having been mixed with betamethasone valerate to produce betaclom. TheTribunal found there was "not significant evidence to support the separate allegationsin relation to the prescription of clomazol", and that this particular was not made out.4[15] The Tribunal then went on to consider the potency of betaclom, notingDr Williams' evidence and the evidence of other witnesses. The Tribunal concludedthat mixing betamethasone valerate with clomazol did not dilute the potency of thebetamethasone valerate, observing instead that mixing might increase its potency.5The Tribunal found that the steroid effect of the betaclom prescribed by Dr Williamswas no less potent than the steroid effect of the betamethasone valerate component inthe betaclom.6[16] The Tribunal then dealt with a defence advanced by Dr Williams under s 100(4)of the Act, namely that he should not be found guilty of a disciplinary offence becausehe had adopted and practiced a theory of medicine and, in doing so, had acted honestlyand in good faith. The Tribunal found that Dr Williams had not adopted and practiceda theory of medicine, taking the view that betaclom was nothing more than a mixtureof two other medicines, each of which had its own function and appropriate use.7 Itaccepted that the medicines can be and are used from time to time in combination, butit observed that, if Dr Williams' theory of medicine was that the potency of thebetamethasone valerate was diluted by the addition of clomazol, this theory did notescape "the inevitable fact that the combination was still in the significantly potentcategory".8 It considered that any honest belief of, or acting in good faith by,4 At [28].5 At [39].6 At [42].7 At [47]-[48].8 At [49].Dr Williams in this regard did not create a new theory of medicine.9 The Tribunal didnot accept that the defence available under s 100(4) of the Act was open toDr Williams.10[17] The Tribunal then considered Dr Williams' use of betaclom despite what weresaid to be repeated concerns raised by others. It reviewed the various expressions ofconcern. It noted the submissions made for Dr Williams, including that it was unfairto suggest that he had ignored the concerns expressed, that he felt he had been "got at"by fellow practitioners, his view that his patients had made good progress usingbetaclom and his assertion there was no evidence of harm to them. It recorded thatDr Williams genuinely believed that betaclom is effective. The Tribunal neverthelessconcluded that the concerns raised should have:11(a) caused Dr Williams to carefully assess his position and undertakefurther enquiry;(b) at the least, caused Dr Williams to discuss with the specialistdermatologist(s) or paediatric dermatologist(s) concerned the cases ofthose patients who he knew or ought to have known were underspecialist care, to determine whether his continued prescribing for thosepatients of a potent topical corticosteroid was appropriate; and(c) caused Dr Williams to have researched the matter further.The Tribunal considered that, instead, Dr Williams continued to prescribebetamethasone valerate and clomazol to the relevant patients mixed together asbetaclom. The Tribunal accepted that the betaclom mixture had been effective,observing that this was because of the significant potency of the topical corticosteroidin it. The Tribunal considered that, for this reason, betaclom was bound to work in theshort-term, but the concern was with the quantities and the potency of the medicineprescribed by Dr Williams. The Tribunal considered that both were "way in excess ofwhat was needed, especially when [the patients] were young infants or children", or9 At [49].10 At [51].11 At [60].where there were "contraindications".12 The Tribunal concluded that Dr Williams'conduct in prescribing betaclom to the individual patients detailed in the charges, inthe circumstances of each, was misconduct as being either malpractice or negligenceand as bringing discredit to the medical profession.13[18] The Tribunal then turned to the allegations in relation to Dr Williams'documenting of patient records. It viewed Dr Williams' records and considered thatthey were inadequate and did not meet appropriate standards (including those set outin the Medical Council's publication – The Maintenance and Retention of PatientRecords) which require clear and accurate reporting of relevant clinical findings,decisions made, information given to patients and any drugs or other treatmentprescribed.14[19] The Tribunal then turned to consider whether disciplinary sanction waswarranted. It noted the purpose of such sanction – to maintain standards in theprofession and to protect the public. It took the view that some of the matters referredto in the particulars of the charges did warrant disciplinary sanction on their ownaccount and that others did so on a cumulative basis. It considered that disciplinarysanction was required both to maintain standards in the profession and to protect thepublic.15 It took the view that it needed to send a clear message to the medicalprofession – namely that the excessive prescription of potent topical corticosteroidssuch as betamethasone valerate and any combination of a potent topical corticosteroidwith another drug such as clomazol, where there have been no adequate trials andapproval, is not acceptable.[20] The Tribunal then went on to consider in detail the individual patients' casesset out in the charges, indicating which particulars it considered warranted disciplinarysanction, either individually, or cumulatively with other particulars relating to thesame patient, or in combination with other particulars in relation to the other patients.Some of the particulars in relation to some patients were found not to have beenproved.12 At [61].13 At [63].14 At [65]-[66].15 At [77].[21] Finally, the Tribunal summarised its findings and went on to deal with penalty.The orders ultimately made by the Tribunal were as follows:16(a) the two charges were found to be made out as professional misconduct;(b) Dr Williams was censured;(c) Dr Williams was fined $10,000;(d) conditions were imposed on Dr Williams' continued practice; and(e) Dr Williams was ordered to pay $145,000 in costs.Interim orders for name suppression were made. They have lapsed and Dr Williams'name has since been published.The notice of appeal[22] Dr Williams in his notice of appeal alleges that the Tribunal erred:(a) in determining that the theory of medicine or healing defence availableunder s 100(4) of the Act was not applicable;(b) in failing either to consider, or to adequately consider, evidence thatother practitioners had adopted and practiced the same theory ofmedicine or healing;(c) by misdirecting itself with regard to the burden of proof on all aspectsof the evidence;(d) in failing to adequately direct itself, or adequately apply, "the principleof threshold requiring any conduct or omission on the part of[Dr Williams] to fall sufficiently seriously below appropriate standardsso as to warrant an adverse disciplinary finding";16 At [236]-[240].(e) in finding that Dr Williams' conduct brought discredit to the medicalprofession;(f) in all the circumstances, determining that an adverse disciplinaryfinding was required "for the purposes of the principles of discipline";and(g) in imposing the fine of $10,000.Approach to the appeal[23] The appeal is brought pursuant to s 106(2)(a) of the Act. It proceeds by wayof rehearing pursuant to s 109(2). As a result, this Court is required to come to its ownview on the merits, after considering and weighing all of the evidence that was beforethe Tribunal. The principles set out by the Supreme Court in Austin, Nichols & Co Incv Stichting Lodestar apply.17 The appellant bears the onus of satisfying this Court onappeal that it should differ from the decision under appeal. It is only if this Courtconsiders that the decision appealed against is wrong that it is justified in interferingwith it. The position was summarised by Elias CJ as follows:[16] Those exercising general rights of appeal are entitled to judgment inaccordance with the opinion of the appellate court, even where that opinion isan assessment of fact and degree and entails a value judgment. If the appellatecourt's opinion is different from the conclusion of the tribunal appealed from,then the decision under appeal is wrong in the only sense that matters, even ifit was a conclusion on which minds might reasonably differ. In suchcircumstances it is an error for the High Court to defer to the lower Court'sassessment of the acceptability and weight to be accorded to the evidence,rather than forming its own opinion.(Citations omitted)[24] The consideration this Court should give to the Tribunal's decision is a matterfor this Court's judgment.18 It may or may not find the reasoning of the Tribunalpersuasive.19 It may be prepared to accept that the Tribunal had a particular advantage,17 Austin, Nichols & Co Inc v Stichting Lodestar [2007] NZSC 103, [2008] 2 NZLR 141.18 At [5].19 At [5].such as technical expertise, or the opportunity to assess the credibility of the witness.20In such cases, this Court can properly hesitate before concluding that the Tribunal'sfindings of fact or of fact and degree are wrong.21 Nevertheless, this Court has theresponsibility of arriving at its own assessment of the merits of the case, and if itconsiders that the first instance decision was wrong, it must act on that view.22[25] This Court can confirm, reverse or modify the Tribunal's decision, and it canmake any other decision or order that the Tribunal could have made.23 Instead ofdetermining the appeal, it can direct the Tribunal to reconsider its decision either inwhole or in part.24AnalysisThe Act[26] The principle purpose of the Act is to protect the health and safety of membersof the public by providing mechanisms to ensure that all health practitioners arecompetent and fit to practice their professions.25 The Act seeks to attain this purposeby, inter alia, providing a consistent accountability regime for all health professions.26[27] Part 3 of the Act provides mechanisms for improving the competence of healthpractitioners – including those involved in the practice of medicine – and for protectingthe public from those practitioners who practice below the required standard ofcompetence, or who are unable to perform their required functions. It containsprovisions allowing health practitioners involved in the practice of medicine to notifythe Medical Council if they have reason to believe that another practitioner may posea risk of harm to the public by practicing below the required standard of competence.27The Medical Council, if it has reason to believe that the practice of a practitioner may20 At [5].21 At [5]. See also Johns v Director of Proceedings [2017] NZHC 2843 at [69].22 At [5]. See also Cole v Professional Conduct Committee of the Nursing Council of New Zealand[2017] NZHC 1178 at [30] and [32]; A v Professional Conduct Committee [2018] NZHC 1623 at[4]-[5].23 Health Practitioners Competence Assurance Act 2003, s 109(3).24 Section 111(1).25 Section 3(1).26 Section 3(2)(a).27 Section 34.pose a risk of harm to the public, must give written notice of that fact to variouspersons.28 It can review a practitioner's competence,29 and in certain cases, it canmake an order for the interim suspension of a practitioner.30 The Act also providesmechanisms for upskilling practitioners, including the provision of competenceprogrammes,31 recertification programmes,32 and the like.[28] Part 4 of the Act is concerned with complaints and professional discipline. Itestablishes professional conduct committees to, inter alia, investigate complaints and,in appropriate cases, lay charges.33 It also establishes the Tribunal,34 which is chargedwith hearing and determining charges brought against practitioners by either theDirector of Proceedings or by a Professional Conduct Committee. The Tribunal hasthe power to impose various penalties.35 It can cancel a practitioner's registration orsuspend his or her registration for a period not exceeding three years. It may orderthat a practitioner practice only in accordance with conditions imposed by theTribunal. It can censure a practitioner and fine the practitioner a sum not exceeding$30,000. It can also order that a practitioner pay part or all of the costs and expensesof, or incidental to, any investigation, inquiry, prosecution or hearing.Professional misconduct[29] The grounds on which health practitioners may be disciplined are set out in theAct. Relevantly, for present purposes, s 100(1) of the Act provides as follows:(1) The Tribunal may make any 1 or more of the orders authorised bysection 101 if, after conducting a hearing on a charge laid undersection 91 against a health practitioner, it makes 1 or more findingsthat—(a) the practitioner has been guilty of professional misconductbecause of any act or omission that, in the judgment of theTribunal, amounts to malpractice or negligence in relation tothe scope of practice in respect of which the practitioner wasregistered at the time that the conduct occurred; or28 Section 35.29 Section 36.30 Section 39.31 Section 40.32 Section 41.33 Section 71.34 Section 84.35 Section 101(1)(a)-(f).(b) the practitioner has been guilty of professional misconductbecause of any act or omission that, in the judgment of theTribunal, has brought or was likely to bring discredit to theprofession that the health practitioner practised at the time thatthe conduct occurred;[30] Dr Williams was charged with professional misconduct under s 100(1)(a)and/or (b).[31] The term "professional misconduct" is not defined in the Act. For presentpurposes, there were two avenues open to the Tribunal:(a) Under s 100(1)(a), a finding of professional misconduct was open tothe Tribunal if it found that Dr Williams' conduct detailed in the chargesamounted to malpractice or negligence in relation to the scope of hispractice as a general practitioner. The Courts have adopted thedefinition of the word "malpractice" contained in various dictionaries– malpractice is immoral, illegal or unethical conduct, or a neglect ofprofessional duties.36 A finding of negligence requires the Tribunal todetermine whether or not the practitioner's acts or omissions fall belowthe standards reasonably expected of a health practitioner in thecircumstances of the person appearing before the Tribunal. Whether ornot there has been a breach of the appropriate standards is measuredagainst the standards of a reasonable body of the practitioner's peers.37(b) Under s 100(1)(b), a finding of professional misconduct was open tothe Tribunal if, in its judgment, Dr Williams' conduct detailed in thecharges brought was likely to bring discredit to the medical profession.It has been noted (in the context of the nursing profession) as follows:38[28] To discredit is to bring harm to the repute orreputation of the profession. The standard must be an objectivestandard with the question to be asked by the Council being36 See, for example, Cole v Professional Conduct Committee of the Nursing Council of New Zealand,above n 22, at [41].37 At [42]; citing Nutall Med 04/03P at [62].38 Collie v Nursing Council of New Zealand [2001] NZAR 74 (HC).whether reasonable members of the public, informed and withknowledge of all the factual circumstances, could reasonablyconclude that the reputation and good-standing of the nursingprofession was lowered by the behaviour of the nurseconcerned.The observations apply also to the medical profession.[32] As the charging body, the PCC had the burden of proving that Dr Williams'conduct amounted to professional misconduct. This meant that it had the task ofputting sufficient evidence before the Tribunal to satisfy it that the facts set out in thecharges were proven, and that those facts were significant enough to amount toprofessional misconduct. The standard of proof was on the balance of probabilities,although in practice, stronger evidence was required of the more serious allegations.39[33] A practitioner against whom a prima facie case has been made out must beprepared to answer the charge.40 If Dr Williams wished to rely on an affirmativedefence, such as that available under s 100(4) of the Act, he had the onus of provingthe facts on which the defence rested.41[34] It is trite law that the Tribunal must apply a two-stage test to determine whetherprofessional misconduct has been established.42 First, it must determine whether thepractitioner's acts or omissions constituted malpractice or negligence or have broughtdiscredit to the medical profession. Secondly, it must determine whether thepractitioner's acts or omissions were significant enough to warrant disciplinarysanction for the purpose of protecting the public or maintaining professional standards.[35] A finding of professional misconduct requires something that is significantenough to attract sanction. In B v Medical Council of New Zealand, Elias J (as shethen was), considering an appeal against a finding of conduct unbecoming underearlier legislation, observed as follows:4339 There is no intermediate standard of proof between the criminal and civil standards – Z v DentalComplaints Assessment Committee [2008] NZSC 55, [2009] 1 NZLR 1 at [102].40 Auckland District Law Society v Leary HC Auckland M1471/84, 12 November 1985 at 18; Colev Professional Conduct Committee of the Nursing Council of New Zealand, above n 22, at [36].41 White v Attorney-General HC Wellington CIV-1999-485-85, CIV-2001-485-864, 28 November2007 at [32]; Jia v Auckland Council [2018] NZHC 1133 at [107].42 F v Medical Practitioners Disciplinary Tribunal [2005] 3 NZLR 774 (CA) at [77] and [80].43 B v Medical Council of New Zealand HC Auckland HC11/96, 8 July 1996. it needs to be recognised that conduct which attracts professionaldiscipline, even at the lower end of the scale, must be conduct which departsfrom acceptable professional standards. That departure must be significantenough to attract sanction for the purposes of protecting the public. Suchprotection is the basis upon which registration under the Act, with itsprivileges is available.This observation has been followed in numerous cases since, and it continues to applyto cases under the Act.[36] It follows that any particular act or omission amounting to negligence ormalpractice, or bringing discredit to the medical profession, may or may not besufficient to constitute professional misconduct. There must be behaviour which fallsseriously short of that which is considered acceptable by competent, ethical andresponsible practitioners, and must not be mere inadvertent error, oversight orcarelessness.44 The Tribunal must assess whether the departure from acceptablestandards has been significant enough to warrant a finding of professional misconductagainst the practitioner.45 It should bear in mind that a finding of professionalmisconduct carries considerable stigma. It sends a very strong message about thepractitioner's failure to properly discharge his or her professional responsibilities. Anadverse finding will likely be keenly felt by the practitioner, and it will inevitably benoted by his or her peers.46 A finding of professional misconduct is a significantmatter, which is reserved only for serious conduct.47The charges against Dr Williams – the matters raised on this appeal[37] As I have already noted, the charges are annexed to this judgment.[38] Dr Williams did not dispute the Tribunal's findings in relation to patient 12.He accepted that he provided dietary advice to patient 12's parents about the use ofgoat's milk in circumstances that departed from accepted medical practice and/or thatresulted in actual harm to patient 12. Nor did Dr Williams dispute the Tribunal'sfinding that his keeping of patients' medical histories was inadequate and in breach of44 Collie v Nursing Council of New Zealand, above n 38, at [21].45 Martin v Director of Proceedings [2010] NZAR 333 (HC) at [30]-[31].46 Vatsyayann v Professional Conduct Committee HC Wellington CIV-2009-482-259, 14 August2009 at [8]; Johns v Director of Proceedings, above n 21, at [84].47 Cole v Professional Conduct Committee of the Nursing Council of New Zealand, above n 22, at[45].acceptable standards. This was a particular alleged in respect of patients 1, 2, 3 and12.[39] I am precluded from reviewing these parts of the Tribunal's decision.48[40] There has been no appeal by the PCC under s 106(3) of the Act against theTribunal's dismissal of some of the particulars alleged in respect of some of thepatients referred to in the charges. Again, I have not considered these parts of theTribunal's decision.[41] Those parts of the charges which remain live on this appeal focus onDr Williams' prescription of betaclom, which is described as being "a combination ofa potent topical steroid (betamethasone valerate 0.1%) and the anti-fungal cream(clomazol 1%)". The charges refer to Dr Williams prescribing this combination tonamed patients, in circumstances which, it is said, amounted to professionalmisconduct. Inter alia, it is alleged that Dr Williams prescribed excessive quantitiesof betamethasone valerate 0.1% to infants, to other young children and to persons incircumstances when he knew, or ought to have known, that treatment withbetamethasone valerate 0.1% was contraindicated – for example, where the patientshad acne and/or where the patients had already been using betamethasone valerate forsome time.The potency of betamethasone valerate 0.1%[42] Betamethasone valerate 0.1% is one of the ingredients in betaclom and it wascommon ground that the PCC had to prove that betamethasone valerate 0.1% was apotent topical steroid.[43] Considerable evidence was adduced on this topic before the Tribunal butcuriously, and unfortunately, it did not make an express finding in relation to it. Rather,the Tribunal stated as follows:4948 Health Practitioners Competence Assurance Act, s 109(4)(a).49 Professional Conduct Committee v Williams, above n 1.22. Betamethasone valerate is an active topical corticosteroid. There wasevidence about levels of its potency relative to other topicalcorticosteroids. Hydrocortisone is graded by Dr Oakley,Dermatologist, Hamilton, as a mild topical corticosteroid and othergrades of potency can range from 2 – 25 times more potent thanhydrocortisone (moderate), 100 – 150 times more (potent) and up to600 times more (very potent). There are other classifications to whichthe Tribunal's attention was drawn, one of which has 7 levels. Therewas also evidence that potency can depend on whether thebetamethasone valerate is cream, lotion, foam or ointment.23. The Tribunal is prepared to take as a guide the levels referred to byDr Oakley but taking into account the other evidence and rangesmentioned. The percentage potency range that she refers to is useful.[44] Before me, both counsel accepted that there was ample evidence on which afactual finding as to the potency of betamethasone valerate 0.1% could and shouldhave been made. Rather than send the matter back to the Tribunal for reconsideration,both invited me to consider the evidence and make the missing factual finding.[45] I have reviewed the available evidence.[46] A number of tables were placed before the Tribunal which ranked the potencyof various topical corticosteroids:(a) There was a table prepared by Dr Amanda Oakley.50 She did not giveevidence but her table was produced without objection in the course ofthe hearing before the Tribunal. It records that the potency of topicalsteroids depends upon the specific molecule, the amount that reachesthe target cell, absorption through the skin, and formulation. It notesthat topical steroids are medicines regulated by health authorities andthat they are classified according to their strength. It uses, as a base forcomparison, a mild topical steroid – hydrocortisone. It states thatbetamethasone valerate is considered to be a potent topical steroid andthat it is 100 - 150 times more potent than hydrocortisone.50 Dr Amanda Oakley Topical Steroids (DermNet New Zealand Trust, 1997; updated 4 January2016).(b) A publication by Medsafe dated December 2005 was also produced tothe Tribunal.51 It classifies hydrocortisone 0.5% and 1% as beingmildly potent and betamethasone valerate 0.1% as being potent.(c) There was also a World Health Organisation publication – WHO ModelPrescribing Information – Drugs used in Skin Diseases52 – whichclassifies topical corticosteroids in seven different classes. Classes 6and 7 are recorded as having low potency. Hydrocortisone acetate iswithin Class 7. Betamethasone valerate cream 0.1% is in Class 5, andit is given a moderate potency ranking.(d) There was an article – Corticosteroids: options in the era of steroid-sparing therapy – by James Del Rosso,53 produced to the Tribunalwhich contains a table setting out a corticosteroid potency chart. It alsodivides corticosteroids into seven classes. Class 7 – the least potent –includes hydrocortisone. Class 5 – said to be "lower mid strength"includes betamethasone valerate 0.1%, either in cream or lotion form.It was common ground that betaclom contained betamethasone valerate 0.1% in creamform.[47] In addition to these publications, various witnesses referred to the potency ofbetamethasone valerate 0.1%:(a) Dr Rademaker, a dermatologist, said in his evidence-in-chief thatbetaclom contained a potent topical corticosteroid. He spoke of therelative potencies being 1% for hydrocortisone, with a 100-folddifference in potency for betamethasone valerate. He also gaveevidence that the betamethasone valerate molecule is in the order of100 times more potent than hydrocortisone.51 Ruth Savage and Marius Rademaker Topical Corticosteroids: Face Facts (Medsafe, PrescriberUpdate 26(2): 30-31, December 2005).52 World Health Organisation WHO Model Prescribing Information – Drugs used in Skin Diseases(World Health Organisation, Geneva, 1997).53 James Del Rosso Corticosteroids: Options in the era of steroid-sparing therapy (JAAD, Vol 53,Issue 1, July 2005).(b) Dr Maplesden, a general practitioner called by the PCC, had prepareda report which was produced in evidence. It described betamethasonevalerate 0.1% cream as being a potent topical steroid. Dr Maplesdenadopted Dr Oakley's table referred to above and also cited the Medsafepublication.(c) Dr Jarrett, a consultant dermatologist who gave evidence regardingDr Williams prescribing for two of the patients referred to in thecharges, said that betamethasone valerate 0.1% "sits in the middle ofthe ladder [of potency] and is considered to be 100 to 150 times morepotent than hydrocortisone".(d) Dr Purvis, a paediatric dermatologist called by the PCC, gave similarevidence, referring to betamethasone valerate 0.1% as being a potenttopical steroid.(e) So did Dr Rowan, a consultant dermatologist.(f) Mr Woods, a pharmacist called to give expert evidence before theTribunal, accepted that Dr Oakley's table could appropriately be usedby the Tribunal. In his evidence-in-chief, he stated that betamethasonevalerate 0.1% is a potent topical corticosteroid. When he was cross-examined, he also referred to the "ladder" of potency, and accepted thatbetamethasone valerate 0.1% sits "somewhere in the middle". He wasreferred to the document noted above in [46](d), and he accepted thataccording to that table, betamethasone valerate 0.1% is a lower mid-strength topical corticosteroid.(g) Dr Williams, in cross-examination, acknowledged that he knew thatbetamethasone is a potent steroid.[48] While there were differences in emphasis, I do not consider that there was anysignificant divergence in opinion. Accordingly, I am prepared to make the findingwhich the Tribunal failed to make. I am satisfied, on the balance of probabilities, thatbetamethasone valerate 0.1% is a moderately potent topical corticosteroid –approximately 100 to 150 times more potent than the mild topical corticosteroid,hydrocortisone. The Tribunal should have made an express finding to this effect. I doso.Did the potency of betamethasone valerate 0.1% change when it was mixed withclomazol to make betaclom?[49] The Tribunal dealt with this issue under the heading "Betaclom – potency".[50] Before me, there was considerable argument as to whether or not the evidentialonus on this issue was on the PCC or on Dr Williams.[51] The charges refer to Dr Williams prescribing a combination of betamethasonevalerate 0.1% and clomazol 1%, and the particulars refer specifically to himprescribing betamethasone valerate 0.1% – as one of the components of betaclom – tonamed patients. The PCC was required to prove, on the balance of probabilities, thatDr Williams prescribed betamethasone valerate 0.1% to the named patients, and thatsuch prescribing, in the circumstances detailed in the charges, amounted toprofessional misconduct. To do this, the PCC had to establish the potency ofbetamethasone valerate in the combination prescribed. The onus in this regard was onthe PCC. To the extent that Dr Williams was relying on a belief that the potency ofbetamethasone valerate 0.1% was reduced by mixing it with clomazol, and/or that thebetamethasone valerate 0.1% was diluted, as part of his "theory of medicine orhealing" defence under s 100(4) of the Act, then the onus was on him to establish this,also on the balance of probabilities.[52] In practice, I do not think that it makes much difference in this case, becausethere was in my judgment ample evidence on which the Tribunal could properlyconclude that the steroid effect of the betamethasone valerate 0.1% in the betaclomcombination prescribed by Dr Williams was no less potent than the betamethasonevalerate 0.1% component in the betaclom. I refer to the following evidence:(a) The primary witness in regard to this issue was the pharmacist –Mr Woods. He gave evidence about the difference betweenconcentration (the weight or volume of an ingredient) and potency (theactivity) of a drug. He said that, when dealing with a potent drug in atopical preparation, "changing the concentration may have littleinfluence on pharmacological effect". As to whether the potency ofbetamethasone valerate 0.1% was reduced when it was mixed with ananti-fungal medicine, such as clomazol, he said:There has been considerable discussion going back over 20years, backed up by experimental evidence, that indicates thatdilution of potent topical corticosteroids (includingbetamethasone valerate) in various bases does not lead to areduction in potency and a reduction in the effect of the steroidas measured by standard measures.Dealing specifically with betaclom, Mr Woods said that the potency ofthe betamethasone valerate component in the compound would not bereduced by dilution, and that dilution would not reduce the adverseeffects of the betamethasone valerate. He said that there are numerouspublications and guidelines from the 1980's onwards which not onlycaution against dilution of a potent steroid, but which go on to advisethat a lower potency agent should be used rather than an attempt madeat dilution.(b) Dr Maplesden said that there is little point in diluting a topical steroid,as its potency is not dependent on concentration. He said that there isrobust clinical evidence to the effect that the dilution of steroid creamsdoes not reduce their potency at a dermal level. He said that he hadbeen unable to find similar evidence supporting a contrary view.(c) Dr Rademaker said that Dr Williams erred in his belief that mixingbetamethasone valerate with another base reduced the potency of themixture. He stated:So, effectively, diluting a steroid by half just doubles theamount of steroid you're giving that patient. So, if you diluted300 grams of betamethasone with clomazol in a similarquantity, you're actually giving 600 grams of thebetamethasone clomazol mixture.(d) Similarly, Dr Purvis said that diluting steroid creams by adding anothersubstance does not reduce the potency of the steroid.(e) Dr Williams partially accepted the views expressed by other witnesses.He said in his evidence-in-chief:I am aware that the 'potency' of the steroid molecules is notchanged by mixing the [betaclom] cream preparation. Themolecules and how they function remain the same.However, contrary to other witnesses, he did go on to assert that thepercentage of active steroid ingredients in betaclom did change – i.e.that it was diluted.[53] All of this evidence points strongly to the conclusion that the potency of thebetamethasone valerate 0.1% was not reduced when it was mixed with clomazol, andthat there was no change in its side effects.[54] Mr Waalkens QC, on behalf of Dr Williams, however placed considerableweight on an answer given by Mr Woods in the course of cross-examination.[55] Mr Woods was shown an article published in a specialist pharmaceuticalpublication,54 dealing with a drug called betamethasone-17-valerate, and reporting thatwhen it was mixed with a hydrophilic cream, the resulting product possessed only afraction of the potency of the initial betamethasone-17-valerate parent compound.Mr Waalkens submitted that, when he was referred to this article, Mr Woods acceptedthat when betamethasone valerate 0.1% was mixed with clomazol, it may have beenthat the compound product was less potent than the betamethasone valerate on its own.Ms Miller's response, on behalf of the PPC, was to argue that Mr Woods' evidenceneeded to be read in context and in full.[56] The relevant passage in the notes of evidence is relatively lengthy. I set it out:54 Jonathan Byrne and others Formulation factors affecting the isomerization rate of betamethasone-17-valerate in a developmental hydrophilic cream - a HPLC and microscopy based stability study(Pharm Development and Technology, 22(4): 537-544, June 2017).Q. as we talked about earlier in terms of the potency of thebetamethasone being wrapped up in that ester, one of the issues withthe cream or that molecule is it's susceptible to an acid and basecatalysed isomerization?A. Correct, yes.Q. And so if it goes through that isomerization process, it loses, forgiveme for the way I am explaining it, but it loses its esterification and itbecomes less potent doesn't it?A. I don't know if I can actually make that leap in logic. There'sobviously going to be some changing chemical structure but I don'tknow –Q. If you look at the article, "This isomerization process is of significantclinical relevance since betamethasone-21-valerate demonstrates only1/15th of the potency", see that?A. Reading that paragraph, yes, that's true.Q. And you agreed with me earlier that the clomazol was an alkalinesubstance?A. The drug is an alkaline substance but clomazol was the product, so Idon't know if the product is an alkaline substance.Q. Go back to the data sheet for that, page 23, clotrimazole, it is areference to that molecule?A. Yes, that's correct.Q. Would it be normal to put that alkaline molecule in an alkalinemolecule in an alkaline base?A. I don't know. It depends on – formulation science is actually a verycomplicated area. It depends on the activity of the antimicrobial, thestabilising agent. So, it's very difficult to make generalisations. Wecan't assume that because clotrimazole is actually alkaline, that thebase would necessarily be alkaline.Q. So, if we can treat it in this way then, Mr Woods, it's possible, isn't it,that the clotrimazole is itself alkaline; just accept that as ahypothetical?A. It's possible, yep.Q. And if that's mixed with the beta cream then you would expect theoverall pH of the mixture to change from the beta cream on its own,wouldn't you?A. Yep, because you're mixing two different products, so the effects onthe pH would be, without measuring it, would be quite unpredictable.Q. And so –CHAIR: It is assuming it's alkaline based in the first place?A. That's right, yes. We're dealing with a lot of unknowns here.MR HOLLOWAY:Q. The point is this, Mr Woods, is that in terms of these patients in thecharges, and this is not an issue for you, there has been evidence aboutside effects or lack thereof and there will certainly be evidence fromDr Williams about the lack of side effects seen in using this mixture.A. Yep.Q. The reason for that may well be because he's right, that it is whenmixed with the clomazol less potent than the beta cream on its own?A. That's correct. It could be but the evidence indicates that that'sunlikely but the main issue is unpredictability. The evidence suggeststhat dilution of potent corticosteroids does not predictably reducepotency but, as you've been working through here, the effects on aformulation by mixing two products together, unless you study thatparticular formulation, we don't actually definitively know. We maybe able to glean from clinical response but we don't actually know theeffects of the formulation.Q. So, when you said a moment ago, you referred again to those studiesusing normal dilutants.A. Mm-mmm.Q. That's one way of looking at it and inferring that situation withclomazol will be the same but, as you've said, and tell me if I'm right,it may well not be the same?A. Correct.Q. And another way of gathering evidence about the effect of themixture, of course, is to observe it in clinical practice?A. That's one way, yep, but that would have to be – normally when we'relooking at the effects of the medicine, it is a little bit more thanobservation in clinical practice. We need a controlled study against abenchmark comparison.Q. Just taking you back to the key point, Mr Woods. When you say that,in your opinion, the potency is unlikely to be affected, and you basethat on the studies from some decades ago that were in a particularsetting, am I right that in respect of this particular combination,moving from the application of this hypothetical to the reality ofwhat's being mixed, is it true that you just don't know whether or notit will be less potent or not without studying it?A. Oh, that's true, that's true.[57] I agree with Ms Miller. The answer relied on by Mr Waalkens (set out in italicsabove) has to be considered in context. I note the following. First, Mr Woods' answerwas based on a hypothetical assumption – that the formulation, clomazol, is alkaline.Secondly, Mr Woods was very careful with his answers – for example, "I don't knowif I can actually make that leap in logic"; "we're dealing with a lot of unknowns here".Thirdly, the relevance of a publication dealing with different drugs – betamethasone-17-valerate and a developmental hydrophilic cream – was not established. Fourthly,insofar as I am aware, there was no evidence that the publication had been peerreviewed. Finally, Mr Woods' answer was equivocal – "it could be" that thebetamethasone valerate 0.1% was diluted, and he hedged the answer by going on tosay that he considered this unlikely. The main issue for him was the predictability ofthe resulting compound.[58] Dr Rademaker was also questioned about the publication by a member of theTribunal. Dr Rademaker accepted that it is possible that the betamethasone valeratehad reduced potency and reduced side effects when mixed into betaclom, but it washis evidence that generally, doctors do not mix proprietary preparations because doingso can change the activity of the active ingredients.[59] The Tribunal's discussion of this evidence was brief. It noted that Mr Woodswas asked about the thesis in the publication, "but none of his answers underminedthe expert evidence he and others had given".55 It also noted that there was no expert55 Professional Conduct Committee v Williams, above n 1, at [38].evidence to the contrary called by Dr Williams. The Tribunal did not expressly referto Dr Rademaker's evidence.[60] Dr Williams has not persuaded me that the Tribunal's conclusion was wrong.The Tribunal took into account Dr Williams' belief that the potency of betamethasonevalerate 0.1% was reduced by dilution when it was mixed with clomazol to makebetaclom. It referred to much of the evidence which was led in relation to the topic(which I have summarised). It did not consider that Mr Woods' answer to ahypothetical question based on assumptions which may or may not have been correctundermined the preponderance of the evidence it had heard. It was entitled to takethat view. In my judgment, the Tribunal did not err when it concluded, on the balanceof probabilities, that the steroid effect in the betaclom was no less potent than that ofthe betamethasone valerate 0.1% component of the betaclom.Guidelines and datasheets[61] Having reached this point, it seems to me that the next step is to consider whenbetamethasone valerate 0.1% could be used and when it should not be used.[62] The Tribunal did not directly address this issue, but it did, at various places inits decision, refer to several guidelines and datasheets that were produced to it relevantto the use of betamethasone valerate 0.1%. These included the following:(a) A 2005 datasheet headed "Information for health professionals - Beta".This datasheet recorded that beta creams, containing betamethasonevalerate 0.1%, were indicated for the treatment of eczema. It recordedas contraindications, situations where patients had acne vulgaris, orwhere children under one year of age had dermatoses. The use offluorinated steroids was contraindicated on the face. It also warned thatlong-term continuous therapy using topical corticosteroids should beavoided where possible, especially in infants and children, and thatinfants and children under four years old should not be treated withtopical steroids for longer than three weeks without medical review.(b) There were similar updated datasheets in February 2009, March 2010and April 2014.(c) A datasheet produced by the Medical Council of New Zealand headed"Good prescribing practice" which recorded that a doctor should onlyprescribe medicines or treatment when he or she had adequatelyassessed the patient's condition and had adequate knowledge of thepatient's needs. It recorded that a doctor, to ensure that prescribing isappropriate and responsible, should be familiar with the indications,side effects, contraindications, major drug interactions, appropriatedosages, effectiveness and cost-effectiveness of the medicinesprescribed. It warned against prescribing indiscriminately, excessivelyor recklessly, and cautioned that prescribing should take place inaccordance with accepted practice and any relevant best practiceguidelines. It also cautioned that prescribing outside of accepted normsshould only occur in special circumstances with the patient's informedconsent, and that in such circumstances, it could be useful to discussthe proposed treatment with a senior colleague before completing theprescription. It advocated for the periodic review of the effectivenessof such treatment and required that a clear and adequate patient recordbe kept. Under the heading "Prescribing unapproved medicines", itstated as follows:You may prescribe unapproved medicines or prescribe medicinesfor a purpose for which they have not been approved but, if youdecide to do so, you should take responsibility for overseeing thepatient's care, including monitoring and any follow-up treatment.You may also like to discuss the patient's treatment with a seniorcolleague. You should also inform the patient:• whether there are any other options available• of any risks, side effects, costs or benefits• that the medicine being prescribed is for an unapproved use• that details relating to the supply of the unapproved medicinewill be supplied to the Director-General of Health.(d) The National Institute for Health and Care Excellence (NICE) Clinicalguideline – "Atopic Eczema in under 12's: diagnosis andmanagement".(e) The Scottish Intercollegiate Guidelines Network (SIGN) –"Management of Atopic Eczema in primary care – A National ClinicalGuideline".[63] Mr Waalkens was critical of an observation made by the Tribunal in its decisionthat prescription must be within accepted guidelines and in compliance with applicabledatasheets.56 He noted that both the SIGN and NICE guidelines record that they arenot mandatory, and he criticised the Tribunal for making no reference to this fact. Healso noted that Dr Williams was not charged with breaching the guidelines.[64] I agree with Mr Waalkens that such guidelines and the datasheets are notmandatory. The relevance of the guidelines and the datasheets was that they set out inconvenient and summary form what is commonly accepted as being good practicewithin the medical profession for the use of topical corticosteroids. They are evidencebased guidance, derived over time. The datasheets, in particular, assist generalpractitioners in ensuring that drugs are used appropriately. The guidelines do notexclude other methods of care, but they do guide health practitioners in treating theirpatients.[65] Dr Williams was aware of the NICE guidelines. He initially said that he hadfollowed the guidelines, but when he was cross-examined in this regard, he acceptedthat he had probably not followed all of it, but rather most of it. He was not aware ofthe SIGN guidelines, and he accepted that he had not come across them in his researchinto the treatment of eczema. He accepted, with hindsight, that he should reasonablyhave looked at or for other guidelines on the treatment of eczema when he wasundertaking his initial research. Dr Williams was cross-examined about hisknowledge of the Medsafe datasheets. He accepted that he was familiar with the56 Professional Conduct Committee v Williams, above n 1, at [77].contraindications in those datasheets relating to the use of betamethasone. Henevertheless defended his use of betaclom containing betamethasone valerate 0.1%,and asserted that he had not acted in a way inconsistent with the information given inthe datasheets.[66] Despite the criticisms levelled against the Tribunal's decision, again, I am notpersuaded that the Tribunal erred in its approach to this matter. When it turned to dealwith the particulars of each charge, it paid careful regard to the circumstances of eachpatient, and Dr Williams' prescribing to the patients concerned. It did so by referenceto the datasheets and guidelines, but it did not apply them inflexibly.[67] Before considering the charges in a little more detail, it is necessary to considerthe theory of medicine or healing defence raised by Dr Williams.Section 100(4) of the Act[68] Section 100(4) reads as follows:No person may be found guilty of a disciplinary offence under this Partmerely because that person has adopted and practised any theory ofmedicine or healing if, in doing so, the person has acted honestly and ingood faith.Dr Williams relied on this provision.[69] In its oral decision, the Tribunal said as follows:One matter relied on by Dr Williams arises under section 104 of the [Act].The submissions for Dr Williams was that his practice was a theory ofmedicine or healing, in respect of which he had acted honestly and ingood faith. The Tribunal does not accept that the application ofBeta/clom as such was a theory of medicine or healing. Beta/clom is acombination of two well-known drugs. The fact that Dr Williams usedthese in combination does not create a theory of medicine. There isevidence of sequential use by others of each of the components ofBeta/clom but it is the combination that the charges address. So, thatbeing so, there is no need to consider other aspects of section 100(4)which the Tribunal finds does not apply.[70] The Tribunal reiterated this in its written decision. It said as follows:5747. The first question raised by [s 100(4)] is whether the practitioner, in thiscase Dr Williams, "has adopted and practised any theory of medicine orhealing" 48. The combined product, Betaclom, is nothing more than a mixture of twoother medicines, betamethasone valerate and clomazol. Those medicineshave their own function and appropriate use and, as Dr Williams'submissions also accept, they can be used and are used from time to timein combination. As noted above, this is clearly within the parameters thatthe medications call for, including from the Medsafe Data Sheets.49. If Dr Williams' theory of medicine is that the dilution of potency of thebetamethasone valerate by the addition of clomazol, which was thoughtby him, he says, at the time to be the case, then that theory of medicinestill does not escape the inevitable fact that the combination was still inthe significantly potent category. Any honest belief or acting in goodfaith by Dr Williams in that regard does not create a new theory ofmedicine.50. The proper use of topical corticosteroids is an accepted medicinepractice. Even if dilution of the potency of these was thought (wrongly)to exist, the same considerations apply in respect of the use of what wouldstill be a potent topical corticosteroid.51. The Tribunal does not accept that section 100(4) of the HPCA Act isavailable to Dr Williams.[71] Mr Waalkens was critical of the Tribunal's reasoning. He argued that it placedan overly restrictive interpretation on the meaning of s 100(4) and that no (or noadequate) reasoning was provided by the Tribunal as to why compounding medicinescannot be regarded as a theory of medicine or healing, coming within the statutorydefence.[72] Ms Miller submitted that the Tribunal was correct in finding that the theory ofmedicine or healing defence did not apply.[73] The leading New Zealand case on the theory of medicine or healing defence isthe decision of the full bench of this Court in Tizard v Medical Council of NewZealand.58 The Court was there dealing with the Medical Practitioners Act 1968. Itcontained the same defence and it was available when a practitioner was charged with57 Professional Conduct Committee v Williams, above n 1.58 Tizard v Medical Council of New Zealand HC Auckland M2390/91, 10 December 1992.disgraceful conduct. The Court first determined what is meant by the words "honestlyand in good faith". It held as follows:59We accordingly hold that the meaning of "honestly and in good faith" issimply "honestly". That does not mean that it is sufficient in every case toexclude liability for what would otherwise be disgraceful conduct that thepractitioner concerned be acting "honestly". That cannot be the case, sincethe use of the words "merely because" in s 58(4) make it plain that honestbelief in the efficacy of a particular theory is not necessarily a sufficientanswer.It does however mean, in our view, that the Council was incorrectly advisedthat the words "in good faith" added an objective test of reasonableness to thesubjective requirement of honesty. That makes it necessary to consider howfar that mistake may have affected the Council's decisions on the variouscharges, and whether it may have resulted in some substantial error ormiscarriage of justice.After considering various overseas authorities, the Court noted as follows:60The cases just reviewed have to be construed having appropriate regard totheir different statutory contexts. It is of interest that, while several have seen"theory of medicine" exceptions as being intended to provide room forminority views, no decision has recognised the idiosyncratic view of a singlepractitioner, unsupported by scientific proof or by a significant number of hisor her fellow practitioners, as "a theory of medicine".That position is hardly surprising. Were it otherwise, a practitioner whohonestly but mistakenly held an opinion which was seen by the rest of his orher profession as being without foundation and bound, if applied, to causegreat harm, could still not be prevented from conducting his practice on thatbasis.The Court considered that the purposes of the professional disciplinary procedures arerelevant. It stated as follows:61The statutory requirements in relation to the registration of medicalpractitioners make it plain that knowledge of the basic principles of medicalscience, as they are understood at the date of the practitioner's registration, isa condition precedent to acceptance for registration. It must, in our opinion,have been intended that practitioners have regard to that fund of knowledge;or, to put it another way, that they should not totally disregard it.59 At 18-19.60 At 23.61 At 24.[74] Counsel referred me to a number of authorities where the s 100(4) affirmativedefence has been raised.62 Insofar as I am aware, no health practitioner in this countryhas yet been successful in invoking it.[75] One of the difficulties in this case was that it was not altogether clear from theevidence what Dr Williams' theory of medicine or healing was. In his evidence-in-chief, Dr Williams explained his approach to treating eczema and to prescribingbetaclom. He said that the purpose of using betaclom was to treat inflammation andfungus infections, that he advised patients to use betaclom cream twice a day oneczema affected areas, and to stop its use once the eczema had resolved. He said thathe advised his patients to recommence using betaclom to manage any flare ups, andthat he advised them to use "enough of the cream" and "not too sparingly". He saidthat he found the use of betaclom as part of an overall treatment programme to be veryeffective. He accepted that mixing topical medicines has the potential to affect thestability of their active ingredients, but he said that logically this is more likely toreduce the potency or available quantity of the steroid and not the other way around.He said that he was aware that the potency of the steroid molecules in thebetamethasone valerate 0.1% was not changed by mixing it into the betaclom creampreparation, but he said that what did change was the percentage of the active steroidingredient within the betaclom cream.[76] Again, when he was cross-examined, Dr Williams said:It was my belief that mixing the two creams would reduce the strength ofthe concentration of the betamethasone, thereby reducing the side effects.I have always been under that belief.[77] It seems to me that, to the extent he had one, Dr Williams' theory of medicineor healing was that betaclom was effective and that the concentration ofbetamethasone valerate 0.1% in betaclom was reduced because it had been dilutedwith the clomazol.62 Re Gorringe HPDT 237/02/89D, 5 August 2003; Re Twentyman HPDT 717/Mid14/280P, 19August 2015; Re Kapua HPDT 227/Mid08/103D, 22 June 2009.[78] I agree with the point made by Mr Waalkens that using a compound of availabledrugs can be a theory of medicine or healing, falling within the statutory defence.However, if a health practitioner wishes to take advantage of the statutory defence, heor she must have acted honestly and in good faith. While Dr Williams no doubthonestly believed that betaclom was an effective treatment for eczema, as this Courtmade clear in Tizard, it is not sufficient to exclude liability for what would otherwisebe disgraceful conduct that the practitioner concerned has acted honestly. Thefollowing are relevant in this case:(a) Dr Williams never tested the potency of betaclom. He developed thecompound in conjunction with a chemist. His assumption as to dilutionwas based on his common-sense logic. There was no scientific prooffor his view as to dilution. When it was put to him that it was a mistakenbelief, Dr Williams said as follows: "Having read about the potency,yes". The evidence established that reasonable enquiry on Dr Williams'part would have identified the generally accepted wisdom that dilutinga steroid does not reduce its potency. Rather, he said that, at the time,potency was not a relevant consideration for him. He was askedwhether he thought it was unreasonable for him not to have consideredpotency issues, when he knew that betamethasone was a potent steroid.He replied "perhaps".(b) Dr Williams did not consult with appropriate and suitably qualifiedspecialists about his common-sense logical deduction regardingdilution because he did not think it was "appropriate" to do so, andbecause "it has been effective". The evidence, however, establishedthat the efficacy of betaclom was due to the betamethasone valerate0.1% in it.(c) Dr Williams was aware of Medsafe datasheets as to the appropriate useof betamethasone, and of at least some of the accepted guidelines onthe use of topical corticosteroids in the treatment of eczema. I agreewith Ms Miller that the evidence, including Dr Williams' evidence,demonstrated that Dr Williams preferred his assumption as to dilutionover published warnings and contraindications for the use ofbetamethasone valerate.(d) The evidence was that the available literature from the 1980's onwardswas to the effect that the potency of potent topical corticosteroids is notreduced by dilution, and that dilution is advised against. WhileDr Williams gave evidence about his research into eczema treatment,he acknowledged that he "failed in [this] part of his research". I agreewith Ms Miller that this part of his research was critical to the safety ofthe betaclom that he was prescribing. As Dr Maplesden put it:I would expect if you had extensively researched something,you would have a good understanding of thepharmacokinetics and the way these drugs work and sideeffect profile etc, perhaps more so than a standard generalpractitioner's not specialising in that area.(e) Dr Williams effectively accepted that betaclom was his "one size fitsall" approach for skin conditions. He acknowledged that prescribingbetaclom was "his usual practice". Indeed, the evidence stronglysuggested that this was the case, and that he did so regardless of eachindividual patient's clinical presentation.(f) Dr Williams' approach to identifying side effects seems to have beencasual. He said that he would look for the appearance of side effects,and that he had never had a case of side effects. Dr Maplesden,however, said:I don't know that the fact that you haven't observed thoserisks to have come to fruition is a very good reason tocontinuing to prescribe against evidence based guidelinerecommendations.(g) Importantly, when concerns were expressed by his fellow healthpractitioners from 2011 onwards, Dr Williams did not reassess hisprescribing practice. Rather, he maintained his view that betaclom waseffective, and that the potency of betamethasone valerate was dilutedwithout undertaking any further research. I agree with the Tribunalwhen it noted that the correspondence should have caused Dr Williamsto carefully reassess his position, and undertake further enquiry andresearch.(h) Dr Williams paid little or no regard to those parts of datasheets andguidelines which discuss accepted medical practice in prescribingtopical corticosteroids and unapproved medicines. He did not keepproper records. He did not consult with others, even when he knew thatpatients were under the care of specialists. As the Court made clear inTizard, practitioners seeking to take advantage of s 100(4) must haveregard to the basic principles of medical science; they cannot totallydisregard that fund of knowledge.[79] In my judgment, when these matters are taken into account, Dr Williams didnot act honestly and in good faith, in the sense discussed in Tizard, when he prescribedbetaclom to the individual patients the subject of the charges.[80] Mr Waalkens argued that the Tribunal did not give sufficient weight toevidence suggesting that betaclom was used by other practitioners.[81] The Tribunal did refer to the evidence of two other practitioners who gaveevidence that they used betaclom, Drs Naden and Finau.(a) The Tribunal observed that Dr Naden's practice in using betaclom wasdifferent in material respects from that of Dr Williams.63 In my view,it was correct to do so. By way of example, Dr Naden said that hetended to avoid treating patients under two years old with betaclom; hewas aware that the over prescribing of steroids should be avoided,especially for those under 15 years; he was aware that the use ofbetaclom should not be continued if there was a chronic or persistenteczema, and that instead the patient should be referred to adermatologist. Dr Naden also said that in his view, betaclom was atreatment of last resort, and that usually a doctor should be able to63 Professional Conduct Committee v Williams, above n 1, at [37].control skin conditions with other preparations with less potency. Healso agreed that less potent steroids should be used on the face, and thatusing a cream that had not been scientifically tested was going into"unknown territory".(b) The Tribunal observed that Dr Finau is a colleague of Dr Williams andthat he followed Dr Williams' practice because Dr Williams introducedit to him.64[82] There was also some evidence before the Tribunal in the form of clinical notessuggesting that 14 other health practitioners, most of whom either worked with or forDr Williams, had used betaclom for their patients. There was also evidence that a lowpotency steroid – hydrocortisone – and clomazol were used together in some othersituations, for example, at Middlemore Hospital by Dr Purvis. The Tribunal acceptedthat there may be occasions where, for a short period, there may be a need to use botha potent topical corticosteroid and an anti-fungal cream, but it considered that theevidence was clear that this must be in small quantities, for a short period and only insituations which are not contraindicated.65[83] The theory of medicine defence is not properly available where the theoryespoused is the idiosyncratic view of a single practitioner, and I do not consider thatthe small number of practitioners who have prescribed betaclom on occasion elevatesDr Williams' views as to the efficacy of betaclom and the dilution of betamethasonevalerate by clomazol into views which are supported by a significant number ofgeneral practitioners.[84] Reading the evidence as a whole, there was no sound body of medical opinionthat supports the use of betamethasone valerate in the way in which it was prescribedby Dr Williams – i.e. large and repeated doses of betamethasone valerate, in the formof betaclom, in situations where it was contraindicated. The weight of the evidencedemonstrated that Dr Williams' prescribing of betaclom containing betamethasonevalerate, was not in conformity with accepted medical practice at the relevant times.64 At [37].65 At [41].The Tribunal was entitled to prefer the evidence of, for example, Drs Maplesden andRademaker over the evidence of Drs Naden and Finau. It was Dr Maplesden'sevidence that on many occasions Dr Williams' prescribing and management advicewas not consistent with accepted management of the conditions being treated.Dr Rademaker agreed. The Tribunal had the advantage of seeing and hearing fromall witnesses, and I am not persuaded that its conclusions in this regard were in error.[85] I have concluded, albeit for slightly different reasons, that the Tribunal did noterr when it held that the s 100(4) defence was not available to Dr Williams.The particulars of the charges[86] No particular criticisms were made by Mr Waalkens of the Tribunal's findingsin regard to each of the patients particularised in the charges. Rather, he argued thatthe Tribunal's findings in regard to each of the patients was significantly influencedby its erroneous conclusions as to the use of betaclom. He argued that if the Tribunal'sfindings with respect to betaclom were quashed, the appeal must succeed.[87] For the reasons I have set out, I do not consider that the Tribunal erred in itsoverall findings as to the use of betaclom. In some respects, my reasoning differs fromthat of the Tribunal, but Dr Williams has not persuaded me that the Tribunal's findingswere wrong.Was Dr Williams' conduct sufficiently serious to warrant disciplinary finding?[88] I have summarised the law above at [29]-[36]. It is well established that towarrant a finding of professional misconduct, there must be behaviour which fallsseriously short of that which is considered to be acceptable.[89] Mr Waalkens queried quite how the Tribunal concluded that the appropriatethreshold was met, given what he said were the facts of this case. He asserted thatthere was controversy regarding the potency of betaclom, that Dr Williams is anexperienced and devoted medical practitioner, that there had been no complaints fromany recipient of betaclom, including the patients detailed in the charges, and that it isimportant that the community has the option of alternative treatments, such asbetaclom. He argued that this case involved issues that are more appropriately dealtwith under the competence/fitness to practice regime contained in Part 3 of the Act,rather than as a disciplinary matter under Part 4, and that an adverse disciplinaryfinding of professional misconduct against Dr Williams was not warranted.[90] As I have already noted, Dr Williams was charged with professionalmisconduct under s 100(1)(a) and/or (b) of the Act, and there were two differentoptions open to the Tribunal – see [31].[91] The Tribunal expressly identified the relevant law in its decision. It recordedthat when it was considering the charge of misconduct, it had to consider whether anyacts or omissions found by it were of such severity as to warrant disciplinarysanction.66 Detailed submissions were made by both parties as to this requirement.The Tribunal had regard to this matter and indeed it devoted part of its decision to theissue. It took into account the submissions made on behalf of Dr Williams as to whydisciplinary sanction was not warranted. It nevertheless concluded that many of theparticulars which it found proved warranted sanction, either on their own, orcumulatively with others.67 It stated as follows:77. as to threshold, the Tribunal is quite satisfied that disciplinarysanction is required to maintain standards in the profession and toprotect the public. The Tribunal needs to send a clear message to themedical profession. This is that the excessive prescription of potenttopical corticosteroids such as betamethasone valerate and anycombination of a potent topical corticosteroid with another drug suchas clomazol where there may not have been adequate trials andapproval [is] not acceptable [92] The Tribunal then went on to consider in detail the particulars in relation toeach patient. Relevantly:(a) Patient 1 was nine months old. She was prescribed betaclom in largequantities, and Dr Williams continued the prescription on a regularbasis. He failed to detect symptoms of Cushing's syndrome. Thisshould have alerted Dr Williams to the fact that betamethasone valerate66 Professional Conduct Committee v Williams, above n 1, at [19].67 At [74].should not have been prescribed to her. He failed to keep appropriatemedical records. Notwithstanding that patient 1 was under the care ofspecialists at Starship Hospital, he failed to consult with thosespecialists. They were trying to reduce the patient's exposure to potentcorticosteroids, and any consultation with them would have made thatclear. Dr Rademaker described the amount of potent topical steroidspresented to patient 1 as "extraordinary", and that it was most unusualto start with prescribing a potent topical corticosteroid, or to continueits use for more than seven days. Dr Maplesden said that Dr Williams'management of this patient would be met with at least moderatedisapproval by his peers.(b) Patient 2 was first prescribed betaclom by Dr Williams when she waseight months old. Dr Williams failed to keep appropriate records. Theamounts of betamethasone valerate that he prescribed to the childdeparted from accepted practice. Dr Rademaker considered thatprescribing a potent topical corticosteroid to this patient wasinappropriate and that its continued use was very inappropriate.Dr Maplesden said that Dr Williams' overall management of thispatient would have been met with moderate to severe disapproval byhis peers.(c) Patient 3 was six months old. Dr Williams prescribed excessivequantities of betamethasone valerate to her and failed to keep adequaterecords. Dr Rademaker noted that first line treatments were not treatedinitially and that prescribing a potent topical corticosteroid wasinappropriate.(d) Patient 4 was aged 16. He had severe facial acne as well as eczema.The datasheets suggested that topical corticosteroids arecontraindicated in the management of acne. The prescription ofbetamethasone valerate by Dr Williams was, in the circumstances,contraindicated, particularly in the quantities in which it wasprescribed. Further, Dr Williams started prescribing betaclom to thepatient after he had received a number of letters of concern from fellowhealth professionals. Dr Rademaker thought that the prescription wasinappropriate. Dr Maplesden said that Dr Williams' prescribing wouldbe regarded with severe disapproval by his peers.(e) Patient 5 was 22 years old. She also suffered from acne as well aseczema. The use of betamethasone valerate was again contraindicated.At the least, the treatment of the two conditions should have beenapproached carefully and appropriately taken account of thedifferences. Again, Dr Maplesden gave evidence that Dr Williams'prescribing would be regarded with severe disapproval.(f) Patient 6 was 17 months old. Betamethasone was prescribed in August2012, October 2012 and September 2013. This was contrary torecommendations made in the Medsafe datasheets. Further, theprescriptions occurred after Dr Williams had received some of theletters of complaint. Dr Rademaker noted that the treatment had notbeen adjusted over time and that excessive amounts of betamethasonevalerate were prescribed.(g) Patient 7 was aged one year. Excessive quantities of betamethasonevalerate were prescribed in circumstances where it was contraindicated,and departed from accepted practice. The prescribing occurred afterthe letters expressing concern. Dr Rademaker said that the prescriptionof betamethasone valerate was inappropriate.(h) Patient 8 was aged two months. Excessive amounts of betamethasonevalerate were prescribed for a baby, including for application on theface, and after numerous concerns had been raised. Dr Rademakernoted that no attempt was made to use a first or second line therapy.Dr Maplesden described this prescribing as reckless and said that itwould be met with severe disapproval by his peers.(i) Patient 9 was three years old. She was seen over a period of nine years.Dr Williams continued prescribing betaclom to her even though shewas advised not to take betaclom by a dermatologist at MiddlemoreHospital. Dr Williams did not consult with the dermatologist. Rather,Dr Williams continued prescribing betaclom because the patientwanted it, contrary to guidelines published in the Medical Council ofNew Zealand's publication, "Good prescribing practice". Some of theprescribing also took place after concerns had been raised withDr Williams. Dr Rademaker considered that the prescription wasinappropriate. Dr Maplesden considered that this prescribing would bemet with moderate to severe criticism by his peers.(j) Patient 10 was an 18-month-old infant. Betaclom was prescribed foruse on, inter alia, her face. This was contrary to general practice, andthe recommendation in the Medsafe datasheets. The prescriptions weremade after concerns had been raised. Dr Maplesden considered thatthis was a significant departure from expected standards of care,warranting severe disapproval by his peers.(k) Patient 11 was a 33-year-old female. Betamethasone valerate wasprescribed by Dr Williams in excessive quantities to her despite the factthat he was told not to do so by another doctor. The prescribingoccurred over a lengthy period and after concerns had been expressed.Dr Rademaker considered that the prescribing was inappropriate.(l) Patient 13 in the second charge was a 48-year-old female. The patienthad acne but Dr Williams prescribed betaclom repeatedly,notwithstanding that it was contraindicated in the circumstances. Theprescribing occurred after concerns had been raised. Dr Maplesdengave evidence that the prescribing in these circumstances would be metwith severe disapproval.[93] Dr Rademaker commented that Dr Williams' prescribing of topicalcorticosteroids was reminiscent of the unrestricted prescribing of potent and topicalsystemic corticosteroids of the mid 1960-70's before medical practitioners becameaware of the risks of potent corticosteroids.[94] As I have noted, none of the specific findings in relation to individual patientswas challenged.[95] The Tribunal held that the circumstances in which Dr Williams prescribedbetamethasone valerate departed from accepted practice, and that his conduct was suchas to warrant disciplinary sanction. It did not find every particular proved. Rather, itconsidered that some of the particulars it found proved warranted sanction on theirown account, and that others did so cumulatively.[96] I agree with the Tribunal that Dr Williams' conduct was serious, and that invery many respects, it fell seriously short of acceptable practice. The prescribing wascontrary to accepted practice as set out in the datasheets and guidelines. The evidencewas that the guidelines have a robust evidential base and that they reference acceptedpractices. It is clear that Dr Williams' practice of prescribing betaclom containingbetamethasone valerate to each of the patients particularised in the charges departedfrom acceptable professional standards. His prescribing was either malpractice ornegligent. It was inconsistent with the purpose of the Act and the disciplinary regimeput in place by it. In my judgment, it was appropriate for the Tribunal to find that thecharge of professional misconduct under s 100(1)(a) was made out. It did not err inreaching that conclusion, and its finding was necessary for the purpose of protectingthe public.[97] This latter element was reinforced in part by Dr Williams' own evidence. TheTribunal was left with the distinct impression that he still considered that his use ofbetamethasone valerate and betaclom was appropriate, at least in certaincircumstances. The Tribunal considered that Dr Williams did not understand thesignificant risks of over prescription of a potent topical corticosteroid such asbetamethasone valerate, although it did acknowledge that he may belatedly haveappreciated the risks in respect of young children, and perhaps, in respect of patientswith acne or psoriasis.68 The Tribunal, when referring to the purpose of sanction, noted68 Professional Conduct Committee v Williams, above n 1, at [75].that in some instances, it is only by penalising the practitioner in a particular case thatlessons can be learnt by that practitioner and by the remainder of the profession, andso that standards can be maintained and the public protected.69[98] I now turn to whether or not Dr Williams' conduct brought discredit to themedical profession.[99] As I have noted at [31](b), this Court has noted that to discredit is to bring harmto the repute or reputation of the profession. The standard is an objective standard –whether reasonable members of the public, informed and with knowledge of all thefactual circumstances, could reasonably conclude that the reputation and good-standing of the profession was lowered by behaviour of the health practitionerconcerned.70[100] This statement of the law was cited by the Tribunal in its decision.71[101] Mr Waalkens argued that there was no evidence to support the finding madeby the Tribunal of professional misconduct under s 100(1)(b) of the Act.[102] I do not accept this submission. I have noted the evidence of Dr Maplesdendealing with a number of the patients above. In my view, that evidence stronglysupports the Tribunal's conclusion that Dr Williams' action in prescribingbetamethasone valerate to the relevant patients brought discredit on the medicalprofession. Dr Williams was in effect prescribing an unapproved medicine, the effectsof which were unpredictable, in large quantities, to patients where its use was in manycases contraindicated.[103] The legislature has entrusted the Tribunal, comprising in large part healthpractitioners, with bringing their collective judgment to bear on individual factsituations, and in determining whether or not conduct by a health practitioner is likelyto bring discredit on the medical profession. The decision in this regard essentially69 At [71].70 Collie v Nursing Council of New Zealand, above n 38, at [28]; cited with approval in Johns vDirector of Proceedings, above n 21, at [77].71 Professional Conduct Committee v Williams, above n 1, at [18].calls for a value judgment. The Tribunal acts in a representative capacity, formulatingstandards which of themselves are representative.72 It is an expert body, well placedto assess and evaluate the seriousness of a practitioner's conduct. Deference isappropriate in respect of the Tribunal's judgment on such matters.73[104] In my judgment, there was evidence, particularly from Dr Maplesden, whogave evidence as an expert general practitioner, which was more than sufficient toaddress the s 100(1)(b) matters. It is clear from the Tribunal's decision that itundertook an objective assessment, based on all of the evidence before it. In myjudgment, it was entitled to reach the conclusion that it did, namely that Dr Williams'conduct brought discredit to the medical profession.74 Again, Dr Williams has notpersuaded me that the Tribunal's decision was wrong in this regard.The fine[105] Mr Waalkens contended that the fine of $10,000 imposed by the Tribunal wasexcessive and unreasonable. It was argued that an adverse finding of professionalmisconduct, together with the costs order of $145,000, and the imposition ofconditions, was more than sufficient penalty, which addressed the various purposes ofdiscipline contained in the Act. It was further put to me that the Tribunal was quitewrong to penalise Dr Williams for his continued expression of belief in the efficacy ofbetaclom, that Dr Williams has modified his use of betaclom, in particular in relationto children under the age of 12, and that in all the circumstances, it was unreasonableto impose any fine on Dr Williams at all.[106] Ms Miller noted that under the Act the Tribunal can impose a fine of up to$30,000. She referred to various cases, which show that fines ordered by the Tribunalhave ranged from $500 for a relatively minor offence, through to $25,000 for a seriouscase of misconduct. She argued that Dr Williams' fine was appropriately positionedat the lower to middle end of the available range.72 Moore v Nursing Council of New Zealand HC Wellington AP100/00, 18 December 2000 at [27]-[28] and [34]-[35].73 Collie v Nursing Council of New Zealand, above n 38, at [15]; Cole v Professional ConductCommittee of the Nursing Council of New Zealand, above n 22, at [38]; A v Professional ConductCommittee, above n 22, at [5].74 Professional Conduct Committee v Williams, above n 1, at [63]-[64].[107] In relation to the fine, the Tribunal observed as follows:228. That reflects the serious aspects of the Charge referred to aboveand takes into account the brief information concerning means. It alsosends a clear message to other practitioners that care must be taken inprescribing and note-taking and that any departures from this whichdo not meet appropriate standards and place the public at risk orjeopardise professional standards or bring discredit to the medicalprofession will be met with a penalty of this kind, if not alsosuspension [108] In my judgment, the following are relevant.[109] First, Dr Williams continued his prescribing practices for more than four yearsafter concerns were first raised with him in 2011. I agree with Ms Miller that thisdemonstrated a lack of insight. Indeed, the Tribunal put it rather more sternly. Itconsidered that Dr Williams' continued prescription of betaclom, containingbetamethasone valerate, was "a cavalier response to the expressions of concern".75[110] Secondly, Dr Williams conceded that he was aware of the repeated concerns.The Tribunal found that his failure to heed those concerns put patients at risk.76 Whilethere is no suggestion that Dr Williams deliberately set out to harm his patients, hisconduct was part of a consistent pattern of deliberately ignoring standards andconcerns raised by his professional peers. The Tribunal found that his prescribing, inmany instances, did pose a risk of harm to patients.[111] Thirdly, the Tribunal was entitled to be concerned that even after hearing all ofthe evidence against him, Dr Williams continued to assert that he would still prescribebetaclom. The Tribunal was understandably alarmed by Dr Williams' position.[112] In my judgment, the Tribunal was obliged in the circumstances to ensure thatthe fine imposed was sufficient to send a strong message to the medical profession.Betaclom was an unapproved medicine. None of the suggested guidelines for the useof unapproved medicines was followed in its use.75 At [224].76 At [224]-[228].[113] I am not persuaded that the fine was inappropriate, and I decline to hold that itwas excessive.Conclusion[114] The appeal is dismissed.Costs[115] The PCC is entitled to its reasonable costs and disbursements.[116] It is my preliminary view that costs should be fixed on a 2B basis. In thisregard, I note that category 2 was proposed by the parties in a joint memorandum dated26 September 2017, and that this position was adopted by Hinton J in her minute of 6October 2017.[117] If counsel are still of the view that costs on a category 2 basis are appropriate,calculation should be relatively straightforward.[118] If there is any disagreement, then I direct as follows:(a) the PCC are to file a memorandum seeking costs and disbursementswithin 10 working days of the date of this judgment; and(b) a memorandum in reply is to be filed by Dr Williams within a further10 day working day period.I will then deal with the issue of costs and disbursements on the papers, unless I requirethe assistance of counsel._______________________________Wylie JANNEXUREIN THE MATTER OF the Health Practitioners CompetenceAssurance Act 2003ANDIN THE MATTER OF Joseph Williams, registered medicalpractitioner of AucklandAMENDED DISCIPLINARY CHARGETAKE NOTICE that a Professional Conduct Committee of theMedical Council established under section 71 of the HealthPractitioners Competence Assurance Act 2003 ("the Act") hasdetermined in accordance with section 80(3)(b) of the Act that adisciplinary charge should be brought against Dr JosephWilliams before the Health Practitioners Disciplinary Tribunal.The Professional Conduct Committee has reason to believethat grounds exist entitling the Tribunal to exercise its powersunder section 100 of the Act.PARTICULARS OF CHARGEPursuant to section 81(2) of the Act, the Professional ConductCommittee lays a charge against Dr Williams that:A. Between on or around April 2006 to January 2015 Dr Williamsprescribed a combination of a potent topical steroid(betamethasone valerate 0.1%) and an antifungal cream(clomazol 1%) to the following patients in circumstances thatamounted to professional misconduct:1. Patient 1: Dr Williams first saw and assessed Patient 1 on oraround 15 January 2014 when she was 9 months old. DrWilliams diagnosed Patient 1 with severe infant seborrhoeaeczema and prescribed betamethasone valerate 0.1% creamtwice daily and clomazol 1% cream twice daily, andprescribed this combination of medication again on 17January 2014; 22 January 2014; 11 February 2014; 7 March2014; and 14 March 2014. In doing so, Dr Williams:(a) Failed to document an adequate medical history (includingcurrent medical conditions and/or other medications);and/or(b) Failed to consult with and/or seek advice from specialistswhen he knew or ought to have known that Patient 1 wasunder specialist care; and/or(c) Continued to prescribe betamethasone valerate 0.1% whenhe ought to have ascertained, by consulting with andseeking advice from specialists involved in Patient 1'streatment, that specialists were trying to reduce Patient 1'sexposure to potent steroids; and/or(d) Prescribed excessive quantities of betamethasone valerate0.1% (approximately 450g) between 15 January 2014 and14 March 2014, which departed from accepted practiceand/or may have posed a risk of harm to the patient; and/or(e) Prescribed a combination of betamethasone valerate 0.1and clomazol 1% when he knew or ought to have knownthat repeated concerns (as detailed in the attachedschedule) had been raised about his prescribing of thistreatment; and/or2. Patient 2: Dr Williams first saw and assessed Patient 2 on 15November 2006 when she was 8 months old. Dr Williamsdiagnosed Patient 2 with severe and generalised eczema andprescribed betamethasone valerate 0.1% cream twice dailyand clomazol 1% cream twice daily. Dr Williams prescribedthis combination of medication again on 29 November 2006;10 January 2007; and 24 January 2007. In doing so, DrWilliams:(a) Failed to document an adequate medical history(including current medical conditions and/or othermedications); and/or(b) Prescribed an excessive amount of betamethasonevalerate 0.1% (approximately 400g over a 2 ½ monthperiod) to a young child, where such prescribing departedfrom accepted practice and/or may have posed a risk ofharm to the patient; and/orFurther, on or around 19 June 2008 Patient 2 wasdiagnosed with Dowling Meara Epidermolysis BullosaSimplex. Following this diagnosis, Dr Williamsprescribed the combination of betamethasone valerate0.1% and clomazol 1% again on 4 August 2010; 28November 2011; and 20 March 2012. In doing so, DrWilliams:(c) Failed to document an adequate medical history and/ornew information about Patient 2's condition; and/or(d) Failed to consult with and/or seek advice from specialistsinvolved in Patient 2's treatment when he knew or oughtto have known that Patient 2 was under specialist care;and/or(e) Prescribed betamethasone valerate 0.1% incircumstances where Patient 2 had been diagnosed witha condition that is not responsive to steroids, and/or forwhich steroids are contraindicated; and/or(f) Prescribed an antifungal cream, clomazol, incircumstances where there was no record or report of afungal infection, such that the prescribing was notclinically justified; and/or3. Patient 3: Dr Williams first saw Patient 3 on or around 4August 2010 when she was 6 months old. She is theyounger sister of Patient 3. Dr Williams diagnosed Patient 3with moderate eczema with sepsis on her neck, arms, legsand thigh. Dr Williams prescribed betamethasone valerate0.1% twice daily and clomazol 1% twice daily. In doing so, DrWilliams:(a) Failed to record an adequate medical history; and/or(b) Prescribed betamethasone valerate 0.1% to a youngchild, where such prescribing departed from acceptedpractice and/or may have posed a risk of harm to thepatient; and/orOn or around 2 December 2010 Patient 3 wasdiagnosed with Dowling Meara Epidermolysis Bullosa.Following this diagnosis, Dr Williams prescribed Patient3 the combination of steroid and antifungal treatmentagain on 28 November 2011 and 20 March 2012. Indoing so, Dr Williams:(c) Failed to record an adequate and/or updated medicalhistory;(d) Failed to consult with and/or seek advice from specialistsinvolved in Patient 2's treatment, when he knew or oughtto have known that Patient 2 was under specialist care;and/or(e) Prescribed betamethasone valerate 0.1% incircumstances where Patient 3 had been diagnosed witha condition that is not responsive to steroids, and/or forwhich steroids are contraindicated; and/or(f) Prescribed an antifungal cream, clomazol, incircumstances where there was no record or report of afungal infection, such that the prescribing was notclinically justified; and/or4. Patient 4: Dr Williams first saw Patient 4 on 22 January 2014when he was 16 years old. Dr Williams diagnosed Patient 4with moderately severe facial acne and eczema secondary toacne. Dr Williams prescribed (among other things)betamethasone valerate 0.1% twice daily and clomazol 1%twice daily, and on 7 February 2014 he advised Patient 4 tocontinue with this treatment and then prescribed the samecombination of medication again on 4 April 2014. In doing so,Dr Williams:(a) Prescribed betamethasone valerate 0.1% for use on theface, and in the presence of acne, when he knew orought to have known that this treatment wascontraindicated and/or departed from accepted practiceand/or may have posed a risk of harm to the patient;and/or(b) Prescribed an antifungal cream, clomazol, incircumstances where there was no record or report of afungal infection, such that the prescribing was notclinically justified; and/or(c) Prescribed a combination of betamethasone valerate 0.1and clomazol 1% when he knew or ought to have knownthat repeated concerns (as detailed in the attachedschedule) had been raised about his prescribing of thistreatment; and/or5. Patient 5: Dr Williams first saw Patient 5 on 27 February2013. He diagnosed her with moderately severe acne on theface, chest and back and eczema secondary to acne. DrWilliams' prescribed (among other things) betamethasonevalerate 0.1% twice daily and clomazol 1% twice daily, andprescribed this combination of medication again on 27 March2013 and 29 July 2013. In doing so, Dr Williams:(a) Prescribed betamethasone valerate 0.1% for use on theface, and in the presence of acne, when he knew orought to have known that this treatment wascontraindicated and/or departed from accepted practiceand/or may have posed a risk of harm to the patient;and/or(b) Prescribed an antifungal cream, clomazol, incircumstances where there was no record or report of afungal infection, such that the prescribing was notclinically justified; and/or(c) Prescribed a combination of betamethasone valerate 0.1and clomazol 1% when he knew or ought to have knownthat repeated concerns (as detailed in the attachedschedule) had been raised about his prescribing of thistreatment; and/or6. Patient 6: Dr Williams first saw Patient 6 on or around 10August 2012 when he was 17 months old. He diagnosedPatient 6 with moderately severe eczema generalised to hisface, neck, arms, legs and trunk. Dr Williams prescribed(among other things) betamethasone valerate 0.1% twicedaily and clomazol 1% twice daily, and again prescribed thistreatment on 19 October 2012 and 18 September 2013. Indoing so, Dr Williams:(a) Prescribed betamethasone valerate 0.1% to a youngchild, including for application to the child's face, when heknew or ought to have known that this treatment wascontraindicated for use on the face and/or departed fromaccepted practice and/or may have posed a risk of harmto the patient; and/or(b) Prescribed an antifungal cream, clomazol, incircumstances where there was no record or report of afungal infection, such that the prescribing was notclinically justified; and/or(c) Prescribed a combination of betamethasone valerate0.1% and clomazol 1% when he knew or ought to haveknown that repeated concerns (as detailed in theattached schedule) had been raised about his prescribingof this treatment; and/or.7. Patient 7: Dr Williams first saw Patient 7 on 19 October 2011,one day before Patient 7's first birthday. He diagnosedPatient 7 with moderate atopic dermatitis/eczema, affectinghis face, neck, arms, legs and trunk. Dr Williams prescribedbetamethasone valerate 0.1% twice daily and clomazol 1%twice daily, and prescribed this combination of medicationagain on 21 September 2012 and 3 March 2014. In doing so,Dr Williams:(a) Prescribed betamethasone valerate 0.1% to a youngchild, including for application to the child's face, when heknew or ought to have known that this treatment wascontraindicated for use on the face and/or departed fromaccepted practice and/or that may have posed a risk ofharm to the patient; and/or(b) Prescribed an antifungal cream, clomazol, incircumstances where there was no record or report of afungal infection, such that the prescribing was notclinically justified; and/or(c) Prescribed a combination of betamethasone valerate 0.1and clomazol 1% when he knew or ought to have knownthat repeated concerns (as detailed in the attachedschedule) had been raised about his prescribing of thistreatment.8. Patient 8: Dr Williams first saw Patient 8 on 22 October2013, when he was two months old. Dr Williams diagnosedhim with severe seborrhoeic eczema generalised to scalp withcradle cap, face, ears, neck, arms, legs and trunk. Heprescribed betamethasone valerate 0.1% twice daily andclomazol 1% twice daily, and prescribed this combination ofmedication again on 29 October 2013. In doing so, DrWilliams:(a) Prescribed an excessive amount of betamethasonevalerate 0.1% (100g in one week) to a young child,including for application to the child's face, incircumstances that departed from accepted practiceand/or may have posed a risk of harm to the patient;and/or(b) Prescribed an antifungal cream, clomazol, incircumstances where there was no record or report of afungal infection, such that the prescribing was notclinically justified; and/or(c) Prescribed a combination of betamethasone valerate0.1% and clomazol 1% when he knew or ought to haveknown that repeated concerns (as detailed in theattached schedule) had been raised about his prescribingof this treatment; and/or9. Patient 9: Dr Williams first saw Patient 9 on 24 September2004 when she was three years old. He diagnosed her withinfantile eczema. Dr Williams prescribed betamethasonevalerate 0.1% twice daily and clomazol 1% twice daily (and/oranother antifungal cream) on or around 11 occasions between21 April 2006 and 7 January 2015. In doing so, Dr Williams:(a) Prescribed betamethasone valerate 0.1% over a nearly 9year period without an adequate record of theappropriateness of the continued treatment, and/orwithout any record of considering the use of a less potentsteroid cream, or a different form of therapy, as isstandard clinical practice; and/or(b) Prescribed an antifungal cream, clomazol, incircumstances where there was no record or report of afungal infection, such that the prescribing was notclinically justified; and/or(c) Prescribed betamethasone valerate 0.1% and clomazol1% on 1 July 2014; 15 July 2014; 24 September 2014;and 7 January 2015 when he knew or ought to haveknown that the Medical Council had issued a notice undersection 35 of the Health Practitioners CompetenceAssurance Act 2003 on 4 June 2014 due to concerns thatDr Williams' "prescribing to children of his own formula ofa topical steroid and antifungal for the treatment of skindisorders poses a risk of harm"; and/or(d) Prescribed betamethasone valerate 0.1% and clomazol1% on 24 September 2014 and 7 January 2015 despiterecording in the clinical notes on 24 September 2014 thatPatient 9's dermatologist had advised her "not to use B/C"(Beta/Clom); and/or(e) Continued to prescribe a combination of betamethasonevalerate 0.1% and clomazol 1% when he knew or oughtto have known that repeated concerns (as detailed in theattached schedule) had been raised about his prescribingof this treatment; and/or10. Patient 10: Dr Williams first saw Patient 10 on 15 April 2014when she was ten months old. He diagnosed her with mildeczema to the face, neck, arms and legs. Dr Williamsprescribed (among other things) betamethasone valerate0.1% twice daily and clomazol 1% twice daily. In doing so, DrWilliams:(a) Prescribed betamethasone valerate 0.1% to a youngchild, including for application to the child's face when heknew or ought to have known that this treatment wascontraindicated and/or departed from accepted practiceand/or may have posed a risk of harm to the patient;and/or(b) Prescribed an antifungal cream, clomazol, incircumstances where there was no record or report of afungal infection, such that the prescribing was notclinically justified; and/or(c) Failed to moderate his method of treatment (namely thecombination of potent topical steroid and antifungalcream) having regard to the severity of Patient 10'ssymptoms, which were described as mild, and by failingto prescribe a mild topical steroid; and/or(d) Prescribed a combination of betamethasone valerate0.1% and clomazol 1% when he knew or ought to haveknown that repeated concerns (as detailed in theattached schedule) had been raised about his prescribingof this treatment; and/or11. Patient 11: Dr Williams first saw Patient 11 on 16 October2013. He diagnosed her with moderate psoriasis andprescribed (among other things) betamethasone valerate0.1% twice daily, clomazol 1% twice daily, and daivobet50/500 30g once daily, and prescribed the combination ofbetamethasone and clomazol treatment again on 21 October2013; 30 October 2013; and 9 December 2013, andprescribed daivobet again on 30 October 2013 and 9December 2013. In doing so, Dr Williams:(a) Prescribed excessive quantities of betamethasonevalerate 0.1% (approximately 500g in 3 months) anddaivobet 50/500 (approximately 200g in 3 months), wheresuch prescribing departed from accepted practice and/ormay have posed a risk of harm to the patient; and/or(b) Prescribed an antifungal cream, clomazol, incircumstances where there was no record or report of afungal infection, such that the prescribing was notclinically justified; and/or(c) Prescribed a combination of betamethasone valerate 0.1and clomazol 1% when he knew or ought to have knownthat repeated concerns (as detailed in the attachedschedule) had been raised about his prescribing of thistreatment.AND/ORB. On or around 12 June 2015 Dr Williams provided dietary adviceabout the use of goat's milk to the parents of 22 month oldPatient 12 in circumstances that departed from accepted medicalpractice and/or that resulted in actual harm to the patient (life-threatening anaphylactic reaction). In addition, Dr Williams:(a) Failed to adequately assess Patient 12's condition, includingby:(i) Failing to elicit and/or take into account Patient 12'sfull allergy history (namely her severe food allergy andprevious cow's milk anaphylaxis) prior to suggestingdietary changes; and/or(ii) Failing to read and/or to take into account Patient 12'sclinical notes which included: "warning: anaphylacticallergy to cow's milk & dairy products"; and/or(b) Failed to document an adequate medical history and/orassessment, including by:(i) Failing to record any reference to Patient 12 havingbeen under the care of Starship Hospital, when heknew or ought to have known that she had been underhospital care; and/or(ii) Failing to record the advice provided to Patient 12'sparents about the use of goat's milk.The conduct alleged above either separately or cumulativelyamounts to professional misconduct pursuant to section100(1)(a) and/or section 100(1)(b) of the Act.Dated at Auckland this day of May 2017_______________________Dr Paul HoggConvenorProfessional Conduct CommitteeSCHEDULECorrespondence and events relating to the concernsraised about Dr Williams' prescribing(a) 14 September 2011: letter from Dr Campbell Brebner (GP LiaisonCounties Manukau DHB) to Dr Williams "regarding a concern that hasbeen brought to our attention related to an aspect of your prescribing".This letter attached an email dated 26 August 2011 from Dr DarionRowan to the CMDHB CMO about Dr Williams' "special cream" (acombination of a potent topical steroid (betamethasone valerate 0.1%)and an antifungal cream (clomazol 1%) ("Beta/Clom")) and a table ofcases where Beta/Clom had been prescribed to patients. On 23September 2011 Dr Williams' replied to Dr Brebner.(b) 10 April 2012: Dr Gloria Johnson made a complaint to the MedicalCouncil about Dr Williams' use of steroids. Her letter attachescorrespondence from Dr Rowan dated 12 March 2012, which raisedconcerns about Dr Williams' use of "Betaclom". Dr Williams was advisedof the complaint, which resulted in a competence review.(c) 12 March 2013: Dr Paul Jarrett wrote to Dr Williams about his prescribingof Beta/Clom to a patient, noting (among other things) that:The adverse side effects of excessive topical steroid use includessuppression of endogenous steroid production, iatrogenic Cushing'ssyndrome, skin thinning, easy bruising, perioral dermatitis,telangectasis formation, striae formation and susceptibility tocutaneous infection.General advice is not to use a potent steroid for more than threeweeks.Dr Williams replied to Dr Jarrett on 27 March 2013.(d) 5 March 2014: Dr Purvis made a complaint to the Medical Council aboutaspects of Dr Williams' practice, including his prescribing of "the sametopical potent steroid/clotrimazole combination cream" Dr Williams wasadvised of the complaint, which resulted in the PCC investigation.(e) 4 April 2014: Dr Purvis copied Dr Williams into a letter raising concernsabout the quantity of topical beta cream prescribed to Patient 1.(f) 7 May 2014: Dr Purvis made a further complaint to the Medical Councilabout Dr Williams' prescribing of this treatment. Dr Williams was advisedof the further complaint.(g) 4 June 2014: The Medical Council issued a notice of risk of harm undersection 35 HPCA Act relating to Dr Williams' prescribing of "his ownformula of a topical steroid and antifungal".(h) 10 September 2014: Dr Jarrett made a complaint to the Medical Councilabout the prolonged use of Beta/Clom prescribed by Dr Williams for twopatients (Patient 5 and Patient 4).IN THE MATTER OF the Health Practitioners CompetenceAssurance Act 2003ANDIN THE MATTER OF Joseph Williams, registered medicalpractitioner of AucklandDISCIPLINARY CHARGETAKE NOTICE that a Professional Conduct Committee of theMedical Council established under section 71 of the HealthPractitioners Competence Assurance Act 2003 ("the Act") hasdetermined in accordance with section 80(3)(b) of the Act that adisciplinary charge should be brought against Dr JosephWilliams before the Health Practitioners Disciplinary Tribunal.The Professional Conduct Committee has reason to believethat grounds exist entitling the Tribunal to exercise its powersunder section 100 of the Act.PARTICULARS OF CHARGEPursuant to section 81(2) of the Act, the Professional ConductCommittee lays a charge against Dr Williams that, between onor around April 2013 to November 2015, Dr Williams prescribeda combination of a potent topical steroid (betamethasonevalerate 0.1%) and an antifungal cream (clomazol 1%) toPatient 13 in circumstances that amounted to professionalmisconduct, as follows:1. Dr Williams first saw Patient 13 on 15 April 2013. He diagnosedher with atopic dermatitis/eczema and prescribed (among otherthings) betamethasone valerate 0.1% cream twice daily andclomazol 1% cream twice daily. He saw Patient 13 again on 29April 2013. Dr Williams recorded that she had facial acne andprescribed the same combination of medication (betamethasonevalerate 0.1% cream and clomazol 1% cream). On 4 December2013, Dr Williams diagnosed Patient 13 with acne vulgaris andprescribed the same combination of medication. Dr Williamsprescribed this combination of medication again on 1 December2014, 23 December 2014, 25 March 2015 and 2 November 2015.In doing so, Dr Williams:(d) Prescribed betamethasone valerate 0.1% for use on the face,and in the presence of acne, when he knew or ought to haveknown that this treatment was contraindicated and/ordeparted from accepted practice and/or may have posed arisk of harm to the patient; and/or(e) Prescribed an antifungal cream, clomazol, in circumstanceswhere there was no record or report of a fungal infection, suchthat the prescribing was not clinically justified; and/or(f) Prescribed a combination of betamethasone valerate 0.1%and clomazol 1% when he knew or ought to have known thatrepeated concerns (as detailed in the attached schedule) hadbeen raised about his prescribing of this treatment; and/or(g) Prescribed betamethasone valerate 0.1% after 5 October2015 when he knew or ought to have known that hiscolleague had advised Patient 13 to see a dermatologist.The conduct alleged above either separately or cumulativelyamounts to professional misconduct pursuant to section100(1)(a) and/or section 100(1)(b) of the Act.Dated at Auckland this day of May 2017_______________________Dr Paul HoggConvenorProfessional Conduct CommitteeSCHEDULECorrespondence and events relating to the concernsraised about Dr Williams' prescribing(a) 14 September 2011: letter from Dr Campbell Brebner (GP LiaisonCounties Manukau DHB) to Dr Williams "regarding a concern that hasbeen brought to our attention related to an aspect of your prescribing".This letter attached an email dated 26 August 2011 from Dr Darion Rowanto the CMDHB CMO about Dr Williams' "special cream" (a combination ofa potent topical steroid (betamethasone valerate 0.1%) and an antifungalcream (clomazol 1%) ("Beta/Clom")) and a table of cases whereBeta/Clom had been prescribed to patients. On 23 September 2011 DrWilliams' replied to Dr Brebner.(b) 10 April 2012: Dr Gloria Johnson made a complaint to the MedicalCouncil about Dr Williams' use of steroids. Her letter attachescorrespondence from Dr Rowan dated 12 March 2012, which raisedconcerns about Dr Williams' use of "Betaclom". Dr Williams was advisedof the complaint, which resulted in a competence review.(c) 12 March 2013: Dr Paul Jarrett wrote to Dr Williams about his prescribingof Beta/Clom to a patient, noting (among other things) that:The adverse side effects of excessive topical steroid use includessuppression of endogenous steroid production, iatrogenic Cushing'ssyndrome, skin thinning, easy bruising, perioral dermatitis,telangectasis formation, striae formation and susceptibility tocutaneous infection.General advice is not to use a potent steroid for more than threeweeks.Dr Williams replied to Dr Jarrett on 27 March 2013.(d) 5 March 2014: Dr Diana Purvis made a complaint to the Medical Councilabout aspects of Dr Williams' practice, including his prescribing of "thesame topical potent steroid/clotrimazole combination cream" DrWilliams was advised of the complaint, which resulted in the PCCinvestigation.(e) 4 April 2014: Dr Purvis copied Dr Williams into a letter raising concernsabout the quantity of topical beta cream prescribed to a young child.(f) 7 May 2014: Dr Purvis made a further complaint to the Medical Councilabout Dr Williams' prescribing of Beta/Clom treatment. Dr Williams wasadvised of the further complaint.(g) 4 June 2014: The Medical Council issued a notice of risk of harm undersection 35 HPCA Act relating to Dr Williams' prescribing to children of "hisown formula of a topical steroid and antifungal".(h) 10 September 2014: Dr Jarrett made a complaint to the Medical Councilabout the prolonged use of Beta/Clom prescribed by Dr Williams to twopatients with acne.