B e f o r e :
MR JUSTICE DAVIS
|| The Queen (on the Application of the Singapore Medical Council)
||- and -
||The General Medical Council
Professor Simon Shorvon
(Transcript of the Handed Down Judgment of
WordWave International Ltd
A Merrill Communications Company
190 Fleet Street, London EC4A 2AG
Tel No: 020 7421 4040 Fax No: 020 7831 8838
Official Shorthand Writers to the Court)
Mr David Pannick QC and Mr Jeremy Hyam (instructed by Leigh Day & Co) for the Claimant
Mr Nigel Pleming QC (instructed by Field Fisher Waterhouse) for the Defendant
Mr Philip Havers QC (instructed by Medical Protection Society) for the Interested Party
Hearing dates: 4th & 5th December 2006
HTML VERSION OF JUDGMENT
Crown Copyright ©
Mr Justice Davis :
- On any view this is most unfortunate litigation. It involves the Singapore Medical Council ("the SMC") alleging with regard to its counterpart in Britain, the General Medical Council ("the GMC"), that the GMC has reached, through a decision of a Chairman of the Investigation Committee, a decision which is wholly unsustainable and irrational; and that the GMC has also, by failing to consult it, breached a duty of fairness said to be owed to the SMC. In the course of its written submissions the SMC has also stated, among other things, that the GMC has, by its conduct in this case, shown that "the GMC does not respect the findings or integrity of the SMC and its procedure". It is further said that the GMC "should not lightly have ignored the findings or the arguments of their equivalent professional body in Singapore" (thereby implying that it has so ignored them); and, still further, that the Chairman in question "unlawfully usurped" the functions of a Fitness to Practise Panel. These strong allegations, as are the overall grounds advanced by the SMC, are in turn strongly denied by the GMC. For his part, the practitioner the subject of the relevant disciplinary proceedings, Professor Simon Shorvon, has challenged the standing of the SMC to bring these present proceedings: and, indeed, has attributed to the SMC an "improper motive" in doing so.
- In a nutshell, the context of the present proceedings is this.
2.1. In 2001 a wide-ranging medical research project was initiated in Singapore. Professor Shorvon was appointed principal lead investigator. Work on the project commenced in about July 2002. Within a few months complaints surfaced about the conduct of the project. There were inquiries and reports.
2.2. Ultimately the SMC conducted its own inquiry. 30 charges were brought against Professor Shorvon. The SMC inquiry was held in Professor Shorvon's absence, he having disputed the SMC's jurisdiction.
2.3. The SMC concluded that Professor Shorvon was guilty of professional misconduct under s.45(1)(d) of the Medical Registration Act (Act 5 of 1997) of Singapore, the SMC announcing its findings on 20th February 2004. It found all the charges proved. It censured Professor Shorvon, required him to give an undertaking, fined him, and directed that his name be removed from the Register of Medical Practitioners in Singapore. He was also ordered to pay costs.
2.4. The GMC had been aware of such proceedings in Singapore. On 1st July 2004 a screener referred charges to a Preliminary Proceedings Committee which in due course on 22nd September 2004 decided that a charge should be formulated and referred the matter to a Fitness to Practise Panel.
2.5. By decision communicated on 23rd September 2005 the Chairman of the Investigation Committee exercising (or purporting to exercise) his powers under the Rules directed that the referral to the Panel be cancelled.
- It is that decision to cancel which is the subject of challenge by the SMC as having been made in circumstances of procedural unfairness and/or as being substantively unsustainable. The Claim Form was issued on 16th December 2005. Permission was granted on 20th February 2006.
- At the hearing before me the SMC was represented by Mr David Pannick QC (appearing with Mr Jeremy Hyam). The GMC was represented by Mr Nigel Pleming QC. Professor Shorvon was represented by Mr Philip Havers QC.
The factual background
- The factual background, in rather more detail, is this.
(a) The inquiries in Singapore
- In August 2001 an application was made for a research project to be carried out in Singapore under the auspices of the National Neuroscience Institute ("NNI"), a medical institution with a particular focus on neurological research and having access to public funding. The NNI is a subsidiary of the National Healthcare Group.
- The main purpose of the project was to identify major genes influencing disease in Singapore's three principal ethnic population groups with regard to disease susceptibility and drug responsiveness in four conditions in particular: epilepsy, Parkinson's Disease, stroke and neuroleptic induced tardive dyskinesia. There were also secondary research objectives, which included contributions to international efforts to define genome-wide patterns of Levo-Dopa in multiple populations. In the grant application to the Biomedical Research Council of Singapore the project was stated to have important functions in terms of training, commercial opportunities, planning of healthcare provision and raising the reputation of Singaporean neuroscience and genomic research.
- Professor Shorvon is a highly accredited and world-renowned researcher in this field. He had applied to come to Singapore as Director of the NNI in December 2000; and in due course he was also appointed principal lead investigator of the project. It is said that the project was at the time one of the largest research projects undertaken in Singapore; and a grant of SGD 10 million (around £3.3 million) had been made by the Biomedical Research Council. A team of scientists and doctors was assembled, including local medical practitioners and also including co-principal investigators. One of the team was a Doctor Ramachandran, who had been a research student of Professor Shorvon at London University. Professor Shorvon himself took the position of Director of the NNI on secondment from University College, London where he was then (as he is now) a Professor of Clinical Neurology. Work started on the project shortly after approval was granted on 17th July 2002.
- Towards the end of November 2002 (that is to say, only a few months after work had started) complaints began to surface. In essence the complaints were of three kinds:
9.1. that Professor Shorvon and his researchers had obtained confidential information relating to epileptic and Parkinson's Disease patients without the knowledge or consent of such patients or their treating physicians.
9.2. that such patients had been recruited to take part in the project without the knowledge or consent of the patients' treating physicians and without the patients' fully informed consent.
9.3. that Professor Shorvon or his researchers under his supervision had prescribed or altered the Levo-Dopa medication of these patients without their knowledge or the consent of their treating physicians.
- In his written submissions in the proceedings before me Professor Shorvon chooses to regard it as very suspicious that the allegations in part were made by a Singaporean co-principal investigator in the project who in due course was made Director in his place.
- On 24th January 2003 the NNI was directed to hold an inquiry and a panel of four doctors was appointed to report. Members of the project team, including Professor Shorvon, were interviewed, as were various doctors from the two relevant hospitals and various patients.
- The NNI Inquiry panel reported on 21st March 2003. In its summary the Panel concluded, among other things, that "the research was carried out in serious breach of ethical guidelines which are applicable in Singapore as well as internationally. The PD [Parkinson's Disease] patients' rights were disregarded and their safety and well-being were compromised in the course of the research." The panel decided that Professor Shorvon and Dr Ramachandran (the Project Manager) "decided to bypass the then PD patients' treating neurologists" in order to obtain blood samples from patients. In addition, the panel concluded that it was decided to undertake Levo-Dopa testing, and to request certain patients to alter their prescribed Levo-Dopa medication, without the patients being fully informed and without their treating neurologists being told. Various other findings were made. Overall, the essential conclusions, among others, were:
12.1. Patient records were disclosed to the project team without patients' consent; and it was deliberately decided not to seek ethics approval for accessing patients' records.
12.2. No ethics approval had been obtained for the Levo-Dopa testing (in contrast to the obtaining of blood samples): this was a breach of proper professional practice and ethical guidelines.
12.3. The well-being and safety of the PD patients had been compromised by reason of the alteration to or omission of their prescribed dosages. The Panel found it "quite unacceptable and unethical" that the patients' treating neurologists were not consulted; and that the Levo-Dopa testing and omission of medication was not done under clinical observation. The Panel stated that: "The patients were treated like experimental subjects without any rights… the patients' welfare was disregarded… the way the testing was done compromised patients' well-being and safety. Such a procedure of testing on human subjects would not be acceptable in any civilised society."
12.4. The Panel further concluded that patients were not told clearly about the Levo-Dopa testing: some did not know their doses were being varied or that their neurologists had not been informed. The Panel further concluded that Professor Shorvon knew and approved of the way in which the Levo-Dopa testing was carried out, and approved the accessing of patients' confidential data and the bypassing of the neurologists. The panel concluded that Professor Shorvon was "responsible for the unethical manner in which the project has been conducted." Strong criticism was also made of Dr Ramachandran, it however being reported that he had now left ("fled", in the language of the NNI report) Singapore.
- Clearly these are serious findings, which in some respects are expressed in highly charged language. Professor Shorvon strongly challenges the fairness and objectivity of the NNI inquiry and the validity of its conclusions. Amongst other points he makes are these:
13.1. He was never shown the Inquiry's terms of reference nor was he told of any specific allegations against him prior to interview: nor (as he says the transcripts show) were the allegations properly put to him in interview.
13.2. He was given no advance disclosure of documents and was asked to comment on them in interview without any advance notice.
13.3. The manner of his questioning, so far from being neutral and objective, was partisan and oppressive (as he says the transcripts show). Further, he was given no opportunity to test the evidence of other witnesses.
13.4. He was given no chance to respond to the Inquiry's conclusions before they were pronounced. He first saw its report after it had been signed.
13.5. The Panel, and its lawyers, lacked independence.
- It is neither appropriate nor possible for me in these proceedings to make any findings on these aspects. But this NNI report does at least set the scene for what has thereafter eventuated. It perhaps, however, should be noted that in some later instructions to counsel from the GMC it was indicated that the SMC's own lawyers subsequently seem to have taken the view that the NNI report was "not as objective as it might have been" (as recorded in some later instructions to counsel from the GMC) – although I am told that the SMC deny that that was ever their view.
- The SMC have emphasised that on 31st March 2003 Professor Shorvon signed a letter directed to the Chairman of the National Health Group (NNI's parent company) stating:
"I refer to your letter dated 25th March 2003. I accept the Report and the conclusions therein."
Professor Shorvon, however, has since stated that he signed such a letter because he was required to do so: in circumstances amounting, in effect, to a degree of duress being exerted, in that he was threatened (as he says) with certain matters being reported to the police and told (as he says) that he would not be permitted to leave Singapore, as by then he was most anxious to do, unless he signed such a letter.
- Also at this time an inquiry had been undertaken by the Ministry of Health in Singapore into the conduct of the project, with a remit of reviewing the process of ethics approval, with particular reference to confidentiality procedures and informed consent procedures; to identify lapses in procedures for ethics approval and observance of ethics requirements; and to make recommendations in that context. The Committee of Inquiry set up by the Ministry of Health in its report issued in March 2003 made a number of recommendations. Its conclusions were different from those of the NNI Inquiry panel: and no personal censure of Professor Shorvon was made. Professor Shorvon made, and makes, no criticisms of the conduct of that particular inquiry or its report. On 3rd April 2003, however, the members of that Committee of Inquiry issued a supplemental letter, apparently sent in the light of the NNI report which by then had been provided to them. This did make criticisms of Professor Shorvon. Professor Shorvon's position is that this further letter was induced solely by the NNI report and did not reflect the Committee of Inquiry's initial report based on its own investigation; and he states that no explanation has been given for this "change of mind" (as he styles it) on the part of the Committee of Inquiry.
- In the event the whole matter was referred by the NNI to the SMC. Professor Shorvon, who had by now returned to the United Kingdom, did not participate in the SMC's inquiry. His position (on legal advice) was that the SMC had no jurisdiction with regard to him; and that was stated, with reasons given, in correspondence between the Medical Protection Society and the SMC. It may be also, I know not, that by now Professor Shorvon had, rightly or wrongly, come to the view, given his experiences, that he was not going to receive a fair hearing in Singapore and that the result was a foregone conclusion. At all events, he did not participate, by his own decision. In due course the SMC determined that it did have jurisdiction with regard to Professor Shorvon. I should add that in due course the Preliminary Proceedings Committee of the GMC stated its view that it did not agree with Professor Shorvon's argument that the SMC did not have jurisdiction.
- The SMC Inquiry hearing went ahead in February 2004. It lasted some ten days. 30 charges had been brought, the first 26 of which relating to the conduct of research with regard to 13 patients with Parkinson's disease. These charges were subdivided into two groups, conveniently categorised as "the best interests charges" and "the informed consent charges" (which primarily related to the manner in which the Levo-Dopa testing was carried out on patients). The remaining four charges related to the alleged failure to obtain ethics approval from the relevant committees for the "on-off" testing that was carried out on patients with Parkinson's disease and to the obtaining of patients' medical data without their consent. Extensive evidence was given before the Inquiry for these purposes. Such evidence included evidence as to what was said to be the adverse effects (actual and potential) on some patients. In addition expert evidence, in the form of a report from Dr Tan, was adduced. His conclusion included the view that "the project was conducted in such a manner that the best interests and health of the PD patients were disregarded…[their] well being were (sic) compromised and they were exposed to real risks which were not properly evaluated and/or minimised."
- The findings of the SMC inquiry were set out in a 21 page document dated 24th February 2004. It summarised the charges; identified the witnesses (36 in number) and documentary materials adduced; and set out its reasons for finding the charges proved having regard to the evidence before it.
- In proceeding to pass sentence the SMC inquiry summarised the position that on the best interest charges Professor Shorvon had failed to safeguard the best interests and health of each of the 13 Parkinson's Disease patients being considered and had exposed them to unnecessary risk. On the informed consent charges Professor Shorvon was found to have failed to obtain the informed consent of each such patient to the "on-off" Levo-Dopa testing. On the confidentiality charges he was found to have breached medical confidentiality in obtaining and using records without the consent of the patients and for the purposes of the project unconnected with their treatment. It was further found that, as supervisor of Dr Ramachandran and as lead principal investigator, Professor Shorvon was "reposed with a heavy responsibility which he had failed to discharge".
- The sentence (which I have already summarised) included a direction that Professor Shorvon's name be removed from the register of medical practitioners. He was also censured, required to give undertakings and fined SPD 5,000 on each charge (subsequently reduced to a total of SPD 10,000 to comply with perceived statutory requirements). He was ordered to pay costs. In due course Professor Shorvon paid such fine and costs, doing so expressly under protest.
(b) Contact between the SMC and the GMC
- In the meantime the matter, by early 2003, had come to the attention of the GMC. Mr Hylton, an Assistant Registrar of the GMC, in his witness statement dated 30th March 2006 says that the matter had first come to the attention of the GMC following an article in the Guardian newspaper dated 20th January 2003: and a file was then opened. Details of the case were in fact subsequently drawn to the attention of the GMC by Professor Shorvon's own defence organisation (the Medical Protection Society).
- On 4th February 2003 the GMC wrote to the NNI, stating that it had become aware of the NNI Inquiry and that Professor Shorvon was registered with the GMC. The GMC asked for a copy of the final report when completed since: "This will enable us to assess if a question arises about Professor Shorvon's fitness to practise."
- On 11th April 2003 the SMC contacted the GMC by e-mail seeking Professor Shorvon's contact details. The response by e-mail to the SMC included a request for a copy of the report when completed. That was followed by a letter from the GMC dated 23rd April 2003 requesting the SMC to send a copy of the papers relating to the SMC investigation, it being indicated that the GMC "would like to consider any information which may raise concerns about [Professor Shorvon's] conduct or performance as a doctor." A letter, to broadly similar effect, was sent on 25th April 2003 asking for a copy of the SMC's report. On 29th April 2003 the SMC replied by e-mail to the letter of 23rd April 2003, also saying that it was its usual practice to inform the GMC if any doctor in Singapore was convicted of professional misconduct by the SMC.
- On 16th September 2003 the SMC wrote a lengthy letter to the GMC to provide an update. The GMC responded by letter of 18th September 2003, asking to know of the outcome of the inquiry and to be sent the relevant papers once concluded. There was then further correspondence, the SMC providing updates in accordance with the GMC's request to be kept informed.
- On 2nd March 2004 the GMC, having been told by the SMC of the outcome before the SMC, sent an e-mail saying that it had not received information from Singapore about the background to the case and requesting copies of bundles. It was said: "We feel this information will be very useful to us in considering the matter fully under our own procedures." There was then further correspondence (by e-mail and letter) on this, copies of the bundles being in due course provided.
- On 28th July 2004 the GMC sent an e-mail to the SMC stating that the information provided by the SMC had now been considered by a medical screener who had determined that the case should be referred to the Preliminary Proceedings Committee ("PPC"). (That was indeed so, the written determination of the screener being made on 1st July 2004.) Such e-mail referred to the options available to the PPC, including referring the matter to the Professional Conduct Committee ("PCC") or, should the PPC decide not to refer the matter, determining that no further action be taken against Professor Shorvon or that advice as to his future conduct be given. It was indicated that the SMC would be contacted further after the forthcoming meeting of the PPC.
- On 24th September 2004 the Fitness to Practise Directorate representative of the GMC wrote to the SMC to say that the PPC had decided that a charge be formulated and that the PCC should hold a public inquiry; and that "it may well be necessary for a member of our solicitors to contact you in the near future in connection with the preparation of the case and we would be grateful for your assistance." The courteous response was that the SMC would certainly provide the GMC with whatever assistance was required. On 2nd November 2004 the SMC wrote to the GMC asking to be kept informed of dates of hearing and of the charges, and offering full assistance, including the sending of the transcripts of the SMC hearing. That letter also said this:
"As you are aware this case raises serious ethical issues in relation to the medical research programme in Singapore. This being the case, [the SMC] would like to be present at the proceedings, through our local counsel who conducted the SMC proceedings in Singapore."
- On 30th November 2004, the SMC sent an e-mail to the GMC saying that it had instructed its solicitors who conducted the prosecution in Singapore to "render any assistance you may need, be it information or documents." Details of that firm, and the contact e-mail addresses of the relevant lawyers, were given. It would appear that thereafter representatives of that firm met representatives of the Fitness to Practise Directorate (and its English solicitors) in London in December 2004 and April 2005: although there was no evidence before me as to what was discussed. A letter from the GMC's solicitors dated 15th April 2005 was sent to the SMC's solicitors in Singapore providing an update; summarising the GMC's duties; and repeating thanks for the information and assistance provided thus far by the SMC. Such letter also explained that the GMC would have to consider the case afresh and to re-examine the facts and that the findings of the SMC could not be adduced for this purpose (for reasons I will come on to explain).
(c) The initial course of the GMC disciplinary proceedings against Professor Shorvon
- As the correspondence between the GMC and the SMC reflects, a charge had indeed been formulated against Professor Shorvon by the decision of the PPC on 22nd September 2004 (following the referral of the matter to it by the screener). The SMC was so informed two days later.
- The reasons of the PPC in deciding to formulate a charge against Professor Shorvon were set out in a detailed letter to him from Mr Hylton dated 14th October 2004. It is not necessary for me to set out here the full detail of such letter: although I have had careful regard to the entirety of what it says.
- The letter set out the background in great detail. It referred to the inquiries and reports of the NNI and the Ministry of Health and the SMC in Singapore. It referred to Professor Shorvon's comments (through the MPS) on those. The letter indicated the view of the PPC that the SMC had had jurisdiction with regard to Professor Shorvon. It referred to a number of expert reports, lodged with the GMC on behalf of Professor Shorvon, stating that "some of the opinions appeared to be general rather than specific to this case, and [the PPC] was unable to discern what information had been considered by the experts when coming to their opinions." The letter also said that the PPC was of "the view that none of the Reports had specifically dealt with the question as to whether informed consent had been obtained for all aspects of the study…" The PPC also referred to a concern that there had been "undoubtedly vulnerable" patients and to its view that Professor Shorvon had "ultimate responsibility" for the research study.
- Various other points were made by the PPC. It noted that "particular caution" was needed if a decision was made to halt a complaint which might be perceived as inconsistent with a decision by another public body. Certain points were made about the admissibility of evidence given in Singapore and as to the weight that could be given to the SMC findings. It was said that the witnesses from Singapore whose evidence was not agreed by Professor Shorvon would have to re-give their evidence and be open to cross-examination. The letter stated:
"Having considered all of the information before it, the Committee was of the view that as lead Principal Investigator Professor Shorvon did have a responsibility over and above that of the other investigators to ensure that the correct procedures were developed and implemented in order that fully informed consent could be obtained from what were vulnerable patients. The Committee was also of the view that there was a real prospect of the facts being proved in this case and that those proved facts could amount to serious professional misconduct…."
- As that letter indicates, reports had indeed been obtained from various experts which were supportive of Professor Shorvon. These were Professor Sever (of the Department of Clinical Psychology, Imperial College, London); Professor Quinn (of the Institute of Neurology, University College, London); and Sir Richard Doll (since deceased) of the Clinical Trial Service and Epidemiological Studies Unit, Nuffield Department of Clinical Medicine, Oxford University. These reports had, in varying degrees of detail, roundly rejected the allegations of serious professional misconduct. Among other things, it was also said that "on-off" testing involving Levo-Dopa medication was by no means unusual and had insignificant side effects. It was further said that practices as to obtaining consent can and do vary.
- Overall, Professor Sever, for example, stated that there was "no case to be made against Professor Shorvon" and that the problems raised in Singapore were to be categorised as minor. Professor Sever made strong criticism of those initiating the charges in Singapore. Professor Quinn in his two reports strongly disagreed with the opinions of Dr Tan (the sole expert medical witness to have given evidence before the SMC). His conclusions, among others, were that there was no evidence that Professor Shorvon had behaved inappropriately or unethically; that the best interests and health of the patients had not been compromised; and that there was "absolutely no evidence to indicate that [Professor Shorvon] was guilty of serious professional misconduct". Sir Richard Doll, in a rather shorter report, set out the background and issues relating to confidentiality and ethics and general management. His conclusion also was to the effect that he identified no serious professional misconduct.
(d) The reference to the Fitness to Practise Panel
- The matter thus was referred by the PPC to the Investigation Committee ("IC") of the Fitness to Practise Panel (previously, under the former rules, designated as "Professional Conduct Committee").
- The Chairman of the IC was, in the event, the same individual who had been Chairman of the PPC dealing with this case.
- By this stage, very experienced solicitors had been retained by the GMC to assist in these disciplinary proceedings; and Joanna Glynn QC (herself very experienced in medical regulatory matters) was also instructed to advise.
- The case of Professor Shorvon was extensively considered and investigated after referral to the IC. Leading Counsel was also instructed on several occasions and gave extensive advice both orally and in writing. She was provided with full materials, including in due course the transcripts of the hearing before the SMC. By oversight, however, she was not provided with a second report of Professor Sever nor with the report of Professor Thompson, Professor of Neurology at the University of Adelaide, which had (in common with the other experts) concluded that the evidence did not indicate that Professor Shorvon's actions in relation to the Parkinson's Disease aspect of the study amounted in any way to serious professional misconduct. These two further reports had in fact been before the PPC at the hearing on 22nd September 2004 but inadvertently had not thereafter been then copied to the GMC's solicitors or (in consequence) Leading Counsel.
- On 4th February 2005 Leading Counsel advised on evidence in writing. She noted that the GMC "is understandably anxious not to have to prove serious professional misconduct afresh because of the enormous logistical problems that will involve." Some of these difficulties were then identified. She summarised the evidence that had been deployed before the SMC and summarised the contentions of Professor Shorvon raised before the GMC. She considered whether the case could be heard under the General Medical Council (Fitness to Practise) Rules 2004 which came into effect from 1st November 2004. Among other things, it was provided by Rule 34(4) that a certificate signed by an officer of a regulatory body that had made a determination about the fitness to practise of a person should be "conclusive evidence" of the facts found proved in relation to that person (a provision not found in the predecessor rules). She concluded that under the relevant transitional provisions the Panel was not empowered to consider the case under such rules, the charge having been referred before 1st November 2004. It is accepted on behalf of the SMC in these proceedings that that was correct advice. The advice concluded that it would also be inappropriate to "re-refer" the matter in an attempt to bring it under the new Rules; and thus that the matter would need to be reheard afresh, with the GMC being required to adduce all the necessary evidence and Professor Shorvon having the right to cross-examine. The correctness of that advice is not disputed before me either. Leading Counsel did, however, comment that "on a more positive note, it is likely that some of the difficulties envisaged by the GMC in obtaining the necessary evidence under the old law may not be as insurmountable as they at first seemed…." (then giving some suggested examples).
- In due course, the GMC decided to instruct for itself yet another expert: noting that Dr Tan's evidence had been part of the SMC proceedings and not being sure to what extent Professor Sever, Professor Quinn and Sir Richard Doll were independent or how much material they had seen. The expert instructed was Professor Williams, Professor of Clinical Neurology at the University of Birmingham. It is not disputed that he was independent, had appropriate expertise and was properly and fully instructed.
- Professor Williams gave his written report on 15th June 2005. He summarised the background and the allegations. He said at one stage: "In a sense the facts seem clear cut." He indicated that he considered that the real issue seemed to be how serious the alleged offences really were. With regard to the Levo-Dopa "on-off" testing, he took the view (as had Professor Quinn and others) that there was a very small danger to patients in omitting or altering doses. As to consent, he among other things commented "They [the patients] knew their own case well and therefore I am sure were given the opportunity to refuse". He expressed the view that at the time in question that sort of testing would not need to go to an ethical board or be mentioned in a written consent form. Overall, on the issue of Levo-Dopa testing, he thought "At the level of one individual's professional misconduct I do not think this is anything like serious enough ….". His overall conclusion included the comment that:
"As with all big studies, particularly ones that fail, there are clearly things that could or should have been done differently. However at the level of serious professional misconduct I cannot find anything here that should cause serious concern about Professor Simon Shorvon."
- In a subsequent e-mail of 29th July 2005 Professor Williams confirmed his familiarity with the various Guidelines (there specified) and stated: "I do not believe Professor Shorvon fell seriously short of any expected standards at the time."
- In the light of the report of Professor Williams of 15th June 2005, the GMC's Solicitors instructed Leading Counsel again.
- On 13th July 2005 Leading Counsel provided her further written advice. She reviewed the position. She at one stage stated "However, in my view the key to assessing the future of this case is the availability of powerful expert evidence". I did not understand Mr Pannick to dispute that that was a legitimate viewpoint. Leading Counsel then went on to advise that: "in my opinion any view to be taken of the strength or otherwise of the case and specifically whether the allegations, if proved, amount to serious professional misconduct depends heavily on the evidence of an expert(s) instructed by the Council." Leading Counsel referred to the expert evidence adduced by the defence (to which might notionally be added, albeit unknown to Leading Counsel or in due course to the IC, the second report of Professor Sever and the report of Professor Thompson). So far as the statement of Dr Tan, the expert deployed before the SMC inquiry, was concerned it was recorded that it was not proposed to rely on him as he might be a witness of fact, as he might have treated some of the patients, and "more importantly he does not have the status or appropriate level of expertise for this case". (He had also, Mr Havers observed, been an employee of the NNI for a period). Mr Pannick accepted that that (viz a decision by the GMC not to rely on Dr Tan) was a view that could properly be reached, albeit it was not a view with which the SMC necessarily agreed.
- Leading Counsel then went on to deal with Professor Williams' report in some detail. In the course of her conclusion Leading Counsel then said this:
"10.1. In the light of the report compiled by Professor Williams, the Council is not currently in a position to prove that Professor Shorvon is guilty of serious professional misconduct. The factual evidence cannot be improved on. In normal circumstances, where the Council's expert evidence is as unequivocal as that provided by Professor Williams, the Council would cancel the inquiry. However, in my view the Council needs to be aware (as I am sure it is) that such a decision will generate a degree of dismay and adverse comment amongst the Singapore medical, and medical regulatory, establishment and the local press. It may also generate press interest here. For these reasons the Council will want to be in a position to justify its decision to all interested parties."
Leading Counsel then referred to there being two options: to obtain yet another report, assuming an expert with the appropriate independence and qualifications could be found, as to the value of which course she had doubts; or to cancel the inquiry (subject to further comment from Professor Williams, which in the event was the subject of his e-mail of 29th July 2005).
- In due course, the Case Presentation Team of the GMC on 9th September 2005 referred the matter to the Chairman, inviting him to consider cancellation. They did so having been advised by their solicitors that on all the evidence available the Council was not in a position to prove serious professional misconduct.
- In a Memorandum from the Chairman dated 19th September 2005 he summarised the position; he noted the advice of counsel and observed "The GMC's own expert is not of the opinion that this would reach the level of [serious professional misconduct] so unless several other experts could be found to contest this view, the case would fail." The Chairman indicated that there should be wariness shown in cancelling cases in the light of a determination by a recognised official investigation and that "in this case I would also be cautious about recommending a cancellation. However because of the expert opinion, the uncontested nature of the proceedings in Singapore (even though that appears to have been Professor Shorvon's choice) and with Counsel's advice about the expert report and evidential difficulties I think that this is the only decision I can reach."
- That decision was notified by letter sent by the GMC to Professor Shorvon on 22nd September 2005. A letter (in somewhat different terms) was sent to the SMC on 23rd September 2005 and received on 27th September 2005. The argument before me in fact focused on the latter letter.
- I have, of course, had careful regard to the full terms of that letter. Among other things the following points were made in it:
50.1 Under the rules, the case before the GMC would have to be reheard: the new rules, permitting the decisions of other regulatory authorities to be accepted as evidence, could not apply. As I have said, Mr Pannick accepts that as accurate.
50.2 Comment was made that "As well as recognising that there may be difficulties in obtaining witness testimony from patients in Singapore, the GMC was mindful that there may be difficulties with the expert reports in this case…". The various expert reports (not, of course, including the second report of Professor Sever or the report of Professor Thompson) were then referred to. It was also stated that it was not proposed to rely on Dr Tan's report.
50.3 The letter then referred to the reasons for obtaining the report of Professor Williams and summarised that report.
50.4 The letter then summarised the advice of Leading Counsel, and noted also that Dr Ramachandran had not been located and in any event it could not be confidently predicted (if he was located) what his evidence to the GMC might be.
50.5 The letter concluded in this way:
"In making his decision to cancel Professor Shorvon's case the Chairman was mindful of various case law and guidance that indicates that the GMC should be wary of cancelling cases that have been referred to it as a result of a determination by another similar regulatory body. However, the Chairman was of the view that even if it were possible to overcome the obvious logistical problems that would arise when trying to have Professor Shorvon's case re-heard in its entirety, Professor Williams' report would be a key piece of evidence. If the Panel accepted Professor Williams' report, and there is no reason to suggest at this time that the Panel should not accept it, then the Panel would in all probability have to conclude that whilst there are aspects of this case that could, in hindsight, have been conducted differently, it could not be said beyond reasonable doubt that Professor Shorvon's conduct in this case amounted to serious professional misconduct.
I should inform you that if further information was to come to light in this case, the GMC may consider whether, in the light of that further information, Professor Shorvon's case should be reopened."
- It is that decision, as communicated to the SMC, which is the subject of this claim for Judicial Review.
(e) Further Communication between the GMC and the SMC
- I have already referred to the earlier communication between the GMC and the SMC by e-mail, letter and (on two occasions) meetings.
- On Friday 12th August 2005 the SMC's solicitors in Singapore sent an e-mail to the GMC's solicitors in London. That asked: "Any indication as to the course you will take in respect of the witnesses or charges etc?"
- The response, also dated Friday 12th August 2005 and timed at 1.15pm (presumably UK time), said this:
"We have been working on this recently, although perhaps not in the expected direction. We identified an expert witness to provide a report on the propriety of conducting large scale research programs of this nature, and we managed to instruct a Professor Williams from Birmingham, UK.
Professor Williams not only had the right level of experience in conducting such trials, but also was a neurologist and therefore was expert in the relevant area that was being studied by Shorvon in Singapore.
We received his report a few weeks ago and it was extremely negative. In short it did not support the case that the conduct of Professor Shorvon in Singapore would amount to "serious professional misconduct". We took instructions and further advice was obtained from Joanna Glynn QC regarding the impact of Professor Williams Report on the case. Her advice essentially was that in the light of Williams' report there would be no realistic prospect of the case succeeding. The only options would be to seek a further report or to refer the case for review in the light of the comments of Professor Williams.
The difficulties in obtaining a second opinion are not insignificant. The Report by Professor Williams would have to be disclosed in any event to Professor Shorvon's legal team, they may use this report in their own case, or when cross-examining any "new" expert. The report is from a respected and senior, entirely independent expert, and there is no reason for calling into question his reputation, therefore the likelihood of getting an alternate expert to disagree is low. The "bank" of available experts in this field is small, as we have found out when trying to instruct an expert at all. (The defence have now produced 3 expert reports of their own all of which are favourable to Professor Shorvon)
I have taken instructions from the GMC and they, in the light of the advice from leading Counsel and the comments of Prof Williams decided against pursuing a second expert opinion.
It is likely that if the case is sent for review on the basis of Prof Williams' report and Counsel's advice, it will be recommended that it be cancelled and no further action be taken.
Although this decision has not been made yet, I do not see any alternative given the independent advice obtained. I thought you would appreciate early notification of this development.
If you would like to discuss this further, please do feel free to call, or e-mail. I will be in the office on Mon, Wed and Thu next week (commencing 15 Aug)."
- It is now said that this e-mail was not received. The witness statement of Professor Nambiar (President of the SMC) dated 14th December 2005 explains it in this way: "I understand this was because of the fact that the IT systems at [the Singapore solicitors] were undergoing upgrading on the 12th August." The source of this "understanding" is not explained and there is no primary or further evidence to confirm that statement or provide any detail. But that evidence has not been disputed before me and I therefore proceed on the basis that the e-mail was not received.
- At all events, the Singapore solicitors did not at that time follow up their e-mail of 12th August 2005: but they did ask about progress by e-mail of 26th September 2005 – which, of course, was very shortly after the Chairman's decision. On that date the GMC's solicitors sent a further e-mail in response to the Singapore solicitors, starting "Further to my e-mail to you of the 12th August." It informed them of the decision to cancel and briefly summarised the reasons. The response was "Hi David, can you resend your e-mail of 12 August 2005. I do not seem to have received it." This was then re-sent.
- The eventual upshot, of course, has been these present proceedings.
The Regulatory framework and relevant Medical Guidelines
- I should refer to the applicable statutory and regulatory framework.
- So far as the SMC is concerned, that is a statutory body operating under the provisions of the Medical Registration Act (Cap 174) of Singapore. Its functions are set out in section 5. Specifically, it is empowered, among other things, by section 5(5) to "determine and regulate the conduct and ethics of registered medical practitioners." It is also empowered by section 5(9) "generally to do all such acts and matters and things as are necessary to be carried out under this Act." Express provision is thereafter made relating to the handling of complaints.
- The Medical Registration Act empowers a Disciplinary Committee of the SMC to make a finding of "professional misconduct": see section 45(2). That, on the extracts of the statute placed before me, is not defined. It is asserted on behalf of the SMC that that is equivalent to "serious professional misconduct" under the statutory provisions then applicable to the GMC. Mr Havers challenged that assertion. I did not have the materials before me to decide such a point: but I doubt if it is significant for present purposes, since I think I can reasonably infer, in the light of the sentence actually imposed by the SMC, that it had concluded that the professional misconduct involved was serious.
- Turning to the GMC, that at the relevant times operated by reference to, among other things, the Medical Act 1983 (as amended). It is common ground that the relevant rules, for present purposes, were the General Medical Council Preliminary Proceedings Committee and Professional Conduct Committee (Procedure) Rules 1988 ("the 1988 Rules"), as amended.
- Those Rules make provision, among other things, for an initial consideration of cases by a screener; for references to a Preliminary Proceedings Committee; and for further references to a Professional Conduct Committee. For present purposes the crucial rule is Rule 19. That reads as follows:
"19. (1) Where, after the Preliminary Proceedings Committee has referred a complaint or information or a conviction to the Committee for inquiry, it appears to the Chairman of the Preliminary Proceedings Committee (having taken into account any observations of any complainant obtained pursuant to paragraph (1A)) that the inquiry should not be held, he may, after consulting a quorum of the Committee, and if they agree, direct that the inquiry shall not be held; and if at the time the direction is given no Notice of inquiry has been sent, rule 17 shall not have effect:
(1A) In any case where there is a complaint the Registrar shall, before the Preliminary Proceedings Committee considers the case under paragraph (1), communicate or endeavour to communicate with the complainant with a view to obtaining the observations of the complainant as to whether the inquiry should be held.
(2) For the purpose of consultation under paragraph (1) the Preliminary Proceedings Committee shall not be required to meet.
(3) Where, after the Registrar has referred a conviction to the Committee for inquiry, it appears to him that the inquiry should not be held, he may direct that the inquiry shall not be held; and if at the time the direction is given no Notice of Inquiry has been sent, rule 17 shall not have effect.
(4) The Registrar shall, as soon as may be after any decision to cancel an inquiry, give notice thereof to the practitioner and to the complainant (if any)."
- Three points may be noted. First, that Rule, on its face, distinguishes between a "complaint" and "information": a distinction also reflected in the wording of other Rules (see, for example, Rule 6(1) dealing with allegations of professional misconduct; and Rule 27(1) (c): that last sub-rule, and other rules, including Rule 19(1A) itself, also showing that not every case will involve a "complainant", as such, at all). Second, Rule 2(1) defines "complainant" as meaning "a body or person by whom a complaint has been made to the Council." Third, the letter of 23rd September 2005 did not, as I see it, purport to be a notification pursuant to Rule 19(4): it was sent, I consider, out of courtesy and as a matter of information to the SMC.
- Entirely new Rules, in the form of the General Medical Council (Fitness to Practise) Rules 2004 were introduced with effect from 1st November 2004. It is the effect of the Medical Act 1983 (Amendment) Order 2002, as was agreed before me, that such Rules could not apply to charges brought before 1st November 2004; as, indeed, Leading Counsel had previously advised the GMC. Thus it was that Rule 34 of the 2004 Rules could not apply here. In addition, Rule 28 of the 2004 Rules contains a discretionary power of cancellation framed in terms different from those set out in Rule 19 of the 1988 Rules. In point of fact, as it happens, the letter of GMC of 23rd September 2005 had suggested that the cancellation may have been made under Rule 28 of the 2004 Rules. It was agreed before me that that was erroneous; but it was also accepted before me that that does not have any bearing on the outcome of this case. Mr Pannick, pragmatically and fairly, said that he took no point that the Chairman may not have consulted a quorum of the Committee.
- In addition, I was referred to an Aide-Memoire published by the GMC outlining the approach to be applied by the PPC in conduct cases. That indicated, in particular, that the task was to decide whether (in its opinion) there was a "real prospect" of serious professional misconduct being established before the PCC: that test – in the context of the ultimate standard being the criminal standard - applying to both the factual allegations and the question whether the facts (if established) would amount to serious professional misconduct. Paragraph 3 set out a (non-exhaustive) list of matters to be borne in mind. These included guidance that the PPC was entitled to assess the weight of evidence but normally should not seek to resolve substantial conflicts of evidence; and that the PPC should proceed with particular caution in reaching a conclusion to halt a complaint which might be perceived as inconsistent with a decision made by another public body.
- Mr Pleming did not dissent from Mr Pannick's submission that such guidance should likewise apply, in an appropriate case (including the present one), to a subsequent decision as to whether or not to cancel. In fact it is plain – as is clear from his Memorandum of 19th September 2005 – that in this case the Chairman of the IC (who had also been the Chairman of the PPC) was well familiar with this Aide Memoire and throughout had it in mind.
- Finally there were referred to me to the various Ethical and Medical Guidelines (and as referred to by, amongst others, Professor Williams in his supplemental communication). In particular Mr Pannick referred me to the GMC Guidance on Good Practice in Research, noting in particular pargraphs 2, 17, 18, 19 and 22. He put particular emphasis on paragraphs 43 and 44 (which relate to vulnerable adults) and paragraph 60 (which stated that it must be made sure that junior colleagues who undertook research were properly supervised); and on paragraph 64 which reads as follows:
"64. If you are leading a team, you must:
76.1. As the correspondence shows, it was not the SMC which initiated the matter with the GMC: the GMC did so of its own volition, having become aware of the proceedings in Singapore.
76.2. Thereafter the correspondence between the GMC and the SMC, fairly read, does not show the SMC to be complaining or making any charge. Rather it was responding to requests for information and assistance and (as one would expect, given its capacity as fellow regulator) offering information and assistance. There was not shown to me any letter or communication which would constitute a formal making of a complaint against Professor Shorvon.
76.3. It is extremely difficult to view the statutory functions of the SMC as extending to inviting, initiating or making charges against a doctor in a different jurisdiction. The functions of the SMC (as Professor Nambiar himself noted in his witness statement) relate to the conduct of disciplinary proceedings against practitioners registered under the Medical Registration Act in Singapore (emphasis added).
76.4. As the wording of the 1988 Rules makes clear, a complainant is not to be equated with an informant.
81.1. The fact that the formulated charges on which the case had been referred to the Fitness to Practise Panel were based on the information supplied to the GMC by the SMC. In my view that adds very little – that will be a quite common scenario in "information" cases. The SMC had pursued its own charges, under the evidence produced to it, under its own procedures. The GMC had to proceed with its own case de novo, with all matters required to be proved (to the criminal standard) by reference to the evidence adduced before the GMC. As Mr Pleming and Mr Havers submitted, and I agree, the mere provision of information cannot of itself give rise to a duty of fairness such as is alleged to be owed.
81.2. The fact that the decision of the PPC to refer the matter to the Fitness to Practise Panel was based on the information provided. But this adds nothing. The view of the PPC was based on all the material then available to it applying its own procedures. (The Chairman of the IC subsequently had other material, and was exercising powers under Rule 19)
81.3. The extensive correspondence between the SMC and the GMC. But, as I have said, that gave rise to no status of "complainant" on the part of the SMC and does not in my view otherwise give any special status to the SMC. Certainly such correspondence contained no promise or representation, express or implied, on the part of the GMC that it would consult the SMC before making decisions or that it would proceed to a public final hearing.
81.4. The fact that the SMC had (so it is said) specific knowledge of some of the matters contained in Professor Williams' report. It is difficult to see how this point, if right, could give rise to a duty of fairness owed to the SMC. In any case, the materials before the SMC, and the conclusions of the SMC, had already been provided to the GMC; indeed it in part was just because of them that Professor Williams' report had been sought.
81.5. The "obvious importance" to the SMC of any decision to cancel. I will comment on this aspect further below: but I find it difficult to see how a duty of fairness can arise from such a viewpoint, in circumstances where the SMC had conducted and completed under its own procedures its own disciplinary process in Singapore and was seemingly functus officio. The GMC owed no duty of subservience to the SMC.
81.6. The extent to which an adverse decision (to cancel) would impact on the findings and integrity of the SMC. This seems to me little more than a variation of the fifth point. Again I will deal with it further below.
81.7. The 1988 Rules. As I have found, the SMC was not a complainant within the 1988 Rules and so no duty of fairness, in the form of a duty of consultation, arises under the express terms of those rules.
82.1. First, as I have mentioned, after the matter was referred by the screener to the PPC the SMC was informed by the GMC of the next stages: and was expressly informed by the e-mail of 28th July 2004 that one option open to the PPC was to decide not to refer the matter to the PCC and that no further action be taken. But it was not submitted to me that a duty to consult the SMC also arose at that stage – viz to enable it to make representations against any possible decision by the PPC not to refer. Nor did the SMC in fact seek to make any representations at that stage against such possible decision, and it did nothing at this stage to indicate to the GMC that the SMC expected to be consulted and to be given the chance to make representations, before any such decision not to refer might be made.
82.2. Second, it is left unexplained as to how far the asserted duty of fairness, requiring the giving of the chance to the SMC to make representations, actually went. Logic would seem to indicate that, on the SMC's argument, the SMC should also have been given the chance to make representations on the evidence of the other experts (Professor Sever, Professor Quinn, Sir Richard Doll etc); to comment on the decision to discount the evidence of Dr Tan; to challenge the advice of Leading Counsel etc. Moreover, logic would seem to indicate, on the SMC's case, that (had there been no decision to cancel) the SMC was owed a continuing duty of fairness to be allowed to make representations on all these matters – and on perhaps all the then prospective evidence – prior to the final full hearing, (with presumably a right to respond on the part of Professor Shorvon). That could give rise to something of a procedural nightmare; and also might cause Professor Shorvon to say he was facing not one prosecutor (which is all the 1988 Rules allowed for) but in truth two. Nevertheless I understood Mr Pannick so to submit that the SMC had such a continuing right and the GMC such a continuing obligation. Yet at the same time he disclaimed any proposition that the SMC had the right to make representations or be heard at the final hearing itself. One can readily see why Mr Pannick made such disclaimer: but it hardly makes for a clear-cut basis for the existence of the asserted duty of fairness.
82.3. Third, I think it is at least a point of comment that, as I understand it, at no stage has the SMC sought to say that, if given the chance at the time, it would have wished to put in expert evidence of its own to rebut Professor Williams. Indeed the SMC has put in no expert evidence of that kind at all in these proceedings.
As will be gathered from this judgment, it is puzzling to me that it can be said that the SMC is a person "affected" by the decision to cancel: and it is impossible to see how the SMC can be described as a "side."
96.1. It is said that the Chairman applied the wrong test in deciding to cancel. There is no basis for that. Rule 19 confers a discretion to cancel in wide terms (as indeed does Rule 28 of the 2004 Rules). Moreover, the Chairman, who had also been the Chairman of the PPC, would have had the provisions of the Aide-Memoire well in mind – as is demonstrated by the reasons given in the decision letter itself. Overall, there is nothing to show that the Chairman applied the wrong test.
96.2. In that regard, it is also clear that the public interest aspects of the matter and the need for particular caution in the light of prospective departure from a related decision of another public body had been borne in mind by the Chairman (and also, of course, that point had been referred to in Leading Counsel's advice). I reject any suggestion that due caution had not been exercised.
96.3. I consider that the assertions that the GMC had "lightly ignored" the findings and reasoning of the SMC (an equivalent professional regulatory body) and that the Chairman had "unlawfully usurped" the functions of the Fitness to Practise Panel to be no more than rhetoric, and unworthy rhetoric at that.
101.1. First, there were logistical difficulties (as set out in Leading Counsel's advice), arising from the accepted fact that as the case had to be tried under the old 1988 Rules the primary facts would need to be reproved, and to the criminal standard. It is utterly unsurprising, in such circumstances, that the matter was alluded to by the Chairman. It was a matter which could properly be taken into account by him.
101.2. Further, the Chairman had in terms not founded his decision solely or even substantially on those potential logistical difficulties. On the contrary, he had formulated his ultimate conclusion essentially by reference to Professor Williams' report (… "even it if were possible to overcome the obvious logistical problems…").
103.1. The first asserted error in Professor Williams' report is that Professor Williams "mistakenly assumes" that the research study involved DNA collection: when, to the stated knowledge of Professor Nambiar, it did not. But (for example) the summary of the NNI report itself showed that it did involve DNA collection. So that point has no force.
103.2. Second, Professor Nambiar suggests that Professor Williams' comments concerning ethics approval applications were "rather misleading". That, at best, is a debatable viewpoint.
103.3. Third, there is criticism of Professor Williams' referrals to the knowledge of other treating neurologists: that presupposing that the evidence before the SMC inquiry would be both replicated before, and accepted by, the GMC. Be that as it may, it does not place that comment of Professor Williams in proper context, as Mr Pleming submitted and I agree.
103.4. Fourth, criticism is made of Professor Williams' assumption, with regard to video-taping, that "it seems most unlikely that (patients) were not given an opportunity to refuse": the observation being also expressed by Professor Nambiar that many of the patients were "vulnerable". But Professor Williams is an expert in this field and could not have overlooked that. This point of itself is of little weight; and in any event Mr Pannick made clear that issues relating to video-taping were of much less significance in the scale of things than the "informed consent" and "best interests" charges.