Sharief v General Medical Council

In these proceedings the appellant (“Dr Sharief”) appeals against the determination of a Fitness to Practise Panel (“the Panel”) of the General Medical Council (“the GMC”) of April 2008 that his fitness to practise was impaired and that his registration be suspended for a period of 12 months. The respondent is therefore the GMC.

At all material times Dr Sharief was employed as a Senior Lecturer in Neurology by King’s College London in which capacity he was responsible for running the Multiple Sclerosis Research Clinic (“the MSRC”). He was the Principal Investigator responsible for identifying and recruiting suitable eligible subjects for clinical trials at the MSRC. These trials were conducted with and on behalf of a number of drug companies. Eligibility for inclusion in each clinical trial was determined by individual criteria set by the sponsoring company and contained in the relevant trial protocol. As the Principal Investigator it was ultimately Dr Sharief’s responsibility to ensure that the potential subjects for inclusion in any such clinical trial met the eligibility criteria of the relevant protocol.

By a Notice of Hearing dated 14^th February 2008 (“the NoH”), Dr Sharief was given formal notice of a number of allegations against him mainly concerning his conduct in respect of six patients (“CAG”, “EH”, “A”, “E”, “MM” and “RYP”), in the context of his assessment of their suitability for admission into various clinical trials.

In the case of the patients CAG and EH, the trial in question was one sponsored by Sereno in respect of its drug “Rebif”, compared with a rival’s product “Avonex”. In the case of patient A, the clinical trial was one sponsored by Biogen and concerned the drug “Natalizumab”. The clinical trial relating to patient E was one sponsored by Active Biotech in respect of the drug “ABR-215062”. In the cases of MM and RYP the trial in question was sponsored by Bristol Myers Squib and concerned the drug “BMS-188667”.

In addition, Dr Sharief was alleged to have forged the signature of a Sub-Investigator, Dr Michael Douglas, on a Biogen Representation and Warranties document and to have asked a research sister at the MSRC (Sister Soudain) to write a signature purporting to be his own on an internal King’s College research grant form.

On behalf of Dr Sharief, Mr Hockton emphasised that none of the patients in question has made any complaint that he or she suffered harm as the result of inclusion in any of the clinical trials or has complained that the inclusion in question had been wrongful. He stressed that the allegations against Dr Sharief were entirely based upon concerns that had been originally expressed by Sister Soudain. Mr Hockton also pointed out that the Panel consisted of three lay members and a General Practitioner and emphasised that none had any relevant expertise in the main subject matter of the case.

The Panel heard the allegations over a period of 14 days between 17^th March and 7^th April 2008. The Panel admitted the witness statements of both patient E and Dr Craighill (patient E’s GP) as evidence. It is worth noting at this stage that there is a challenge to the lawfulness of the Panel’s decision to admit patient E’s statement into evidence (as to which, see below). The Panel also heard oral evidence from: (i) Sister Soudain (the Senior Research Manager at the MSRC); (ii) Professor Hughes (the retired Deputy Head of the Department of Clinical Neurosciences); (iii) Dr Davies (Registrar in Neurology); (iv) Professor Miller (Professor of Clinical Neurology and Consultant Neurologist); (v) Dr Kularatne (Patient E’s previous GP); (vi) Dr Douglas (Clinical Lecturer in Neurology); and (vi) Professor Yousry (Professor of Neuroradiology and an Honorary Consultant).

The Panel also heard expert evidence from Dr Butler (Consultant Neuroradiologist) and Dr Hawkins (Reader in Clinical Neurology and a Consultant Neurologist) on behalf of the GMC and from Professor Bates (Professor of Clinical Neurology) on behalf of Dr Sharief.

Having heard such evidence and submissions on behalf of the Appellant and the GMC and having deliberated for over a day, the Panel found the following allegations proved (the relevant paragraphs of the NoH are given with regard to each such allegation):

The Panel then proceeded to consider whether, on the basis of the facts found, Dr Sharief’s fitness to practise was impaired by reason of misconduct and concluded that it was (“the Determination on Impairment”).

The Panel therefore proceeded to consider what action, if any, it should take with regard to Dr Sharief’s registration. The Panel rejected the GMC’s submission that the only appropriate sanction was erasure and decided that it was appropriate, proportionate and sufficient to direct that his registration be suspended for a period of 12 months (“the Determination on Sanction”). No order for immediate suspension was made.

Dr Sharief appeals against each of the findings of fact set out in paragraph 9 above except that, in the case of the document signed by Sister Soudain (i.e. the allegation in paragraph 21 of the NoH: see paragraph 9(8) above), whilst Dr Sharief accepts that his actions were misleading, inappropriate and unprofessional he challenges the finding that they were dishonest.

Mr Hockton made it clear that, on the basis of the facts as found, the Panel was justified in finding that Dr Sharief’s fitness to practise was impaired as a result and in deciding that his registration should be suspended for 12 months. Accordingly, no issue arises in respect of the Panel’s determinations on impairment and sanction unless I conclude that any of the underlying findings of fact were wrong and/or not supported by the evidence. It was common ground that, if I were to come to such a conclusion, it would then be necessary to go on and decide whether the substituted or amended findings of fact were of such a nature and extent as to vitiate the Panel’s determinations on impairment and sanction.

The powers of a Fitness to Practise Panel (“an FTP Panel”) are contained in section 35D(2) of the Medical Act 1983 (“the 1983 Act”) which, so far as material, provides as follows:

“Where the Panel find that the person’s fitness to practise is impaired they may, if they think fit –

(a)

except in a health case, direct that the person’s name be erased from the register;

(b)

direct that his registration in the register shall be suspended … during such period not exceeding twelve months as may be specified in the direction, or

(c)

direct that his registration shall be conditional on his compliance, during such period not exceeding three years as may be specified in the direction, with such requirements so specified as the Panel think fit to impose for the protection of members of the public or in his interests.”

The procedure to be adopted by an FTP Panel in a substantive hearing is set out in the General Medical Council (Fitness to Practise) Rules Order of Council 2004 (“the 2004 Rules”). Rule 17 provides for a substantive hearing to consist of three stages: (1) the fact-finding stage (see rule 17(2)(c) to (i)); (2) the impairment stage (see rule 17(2)(j) and (k)); and (3) the sanction stage (see rule 17(2)(l) to (n)).

The task of the FTP Panel at each stage is separate and distinct: see Cohen v General Medical Council (2008) EWHC 581 (Admin) at paragraph 16. At the fact-finding stage, the task of the Panel is to consider the factual allegations set out in the heads of charge and decide on the evidence whether they are proved. At the impairment stage, the Panel is required to consider whether, in the light of the facts found proved and any other relevant factors, the practitioner’s fitness to practise is impaired. At the sanctions stage, the task of the Panel is to determine what, if any, sanction to impose on the practitioner if the Panel has found that his or her fitness to practise is impaired.

The High Court’s powers on an appeal by a doctor against a decision of an FTP Panel are set out in section 40(7) of the 1983 Act which, so far as material, provides as follows:

“On an appeal under this section from a Fitness to Practise Panel, the court may –

(a)

dismiss the appeal;

(b)

allow the appeal and quash the direction or variation appealed against;

(c)

substitute for the direction or variation appealed against any other direction … which could have been given or made by the Fitness to Practise Panel; or

(d)

remit the case to the Registrar for him to refer it to a Fitness to Practise Panel to dispose of the case in accordance with the directions of the court.”

The court should only allow the appeal where it is satisfied that the decision of the FTP Panel was (a) wrong or (b) unjust because of a serious procedural or other irregularity in the proceedings of the lower court: see CPR Rule 52.11(3). Furthermore, as Ms Gallafent observed on behalf of the GMC, it is for the appellant to show that the decision in question is wrong and/or unjust.

By virtue of paragraph 22.3(2) of the Part 52 Practice Direction, the appeal is by way of re-hearing, which is usually (and was, in this case) conducted on the basis of a transcript of the hearing below: see, for example, Threlfall ~v~ General Optical Council (2004) EWHC (Admin) at paragraph 21.

In GMC ~v~ Meadow (2006) EWCA Civ 1390 (“Meadow”), the Court of Appeal gave guidance on the proper approach to be adopted on an appeal against a finding of serious professional misconduct under the previous statutory regime. Auld LJ (with whom the other members of the Court agreed) upheld Collin J’s simple expression of the appropriate test (namely, that a court would not interfere with the decision of the FTP Panel unless persuaded that the decision in question was “clearly wrong”) save that he doubted “whether the adverbial emphasis of “ clearly ” adds anything logically or legally to an appellate court’s characterisation of the decision below as “ wrong ”.” Auld LJ went on to make the following observations in conclusion (see paragraph 197):

“On an appeal from a determination by the GMC, acting formerly and in this case through the FPP, or now under the new statutory regime, whatever label is given to the section 40 test, it is plain from the authorities that the Court must have in mind and give such weight as appropriate in the circumstances to the following factors:

(i)

The body from whom the appeal lies is a specialist tribunal whose understanding of what the medical profession expect of its members in matters of medical practise deserve respect;

(ii)

The tribunal has the benefit, which the Court normally does not, of hearing and seeing the witnesses on both sides;

(iii)

The question of primary and secondary facts and the overall value judgment to be made by a tribunal, especially the last, are akin to jury questions to which there may reasonably be different answers.” (Original emphasis).

In paragraph 10 of his judgment in Gupta ~v~ General Medical Council (PC) (2002) 1 WLR 169 (“Gupta”), Lord Rodger described the approach that should be adopted by the appellate court to such appeals in the following terms:

“[T]he obvious fact [is] that the appeals are conducted on the basis of the transcript of the hearing and that, unless exceptionally, witnesses are not recalled. In this respect, these appeals are similar to many other appeals in both civil and criminal cases from a judge, jury or other body who has seen and heard the witnesses. In all such cases the appeal court readily acknowledges that the first instance body enjoys an advantage which the appeal court does not have, precisely because that body is in a better position to judge the credibility and reliability of the evidence given by the witnesses. In some appeals that advantage may not be significant since the witness’ credibility and reliability are not in issue. But in many cases the advantage is very significant and the appeal court recognises that it should accordingly be slow to interfere with the decisions on matters of fact taken by the first instance body. This reluctance to interfere is not due to any lack of jurisdiction to do so. Rather, in exercising its full jurisdiction, the appeal court acknowledges that, if the first instance body has observed the witnesses and weighed their evidence, its decision on such matters is more likely to be correct than any decision of a court which cannot deploy those factors when assessing the position. In considering appeals on matters of fact from the various professional conduct committees, the Board must inevitably follow the same general approach. Which means that, where acute issues arise as to the credibility of reliability of the evidence given before such a committee, the Board, duly exercising its appellate function, will tend to be unable properly to differ from the decisions as to fact reached by the committee except in the kinds of situation described by Lord Thankerton in the well known passage in Watt or Thomas ~v~ Watt (1947) AC 484, 487-488.”

The passage from Lord Thankerton’s speech in Watt ~v~ Watt, to which Lord Rodger referred in Gupta is in the following terms:

“I do not find it necessary to review the many decisions of this House, for it seems to me that the principle embodied therein is a simple one, and may be stated thus: I. Where a question of fact has been tried by a judge without a jury, and there is no question of misdirection of himself by the judge, an appellate court which is disposed to come to a different conclusion on the printed evidence, should not do so unless it is satisfied that any advantage enjoyed by the trial judge by reason of having seen and heard the witnesses could not be sufficient to explain or justify the trial judge’s conclusion; II. The appellate court may take the view that, without having seen or heard the witnesses, it is not in a position to come to any satisfactory conclusion on the printed evidence; III. The appellate court, either because the reasons given by the trial judge are not satisfactory, or because it unmistakably so appears from the evidence, may be satisfied that he has not taken proper advantage of his having seen and heard the witnesses, and the matter will then become at large for the appellate court. It is obvious that the value and importance of having seen and heard the witnesses will vary according to the class of case, and, it may be, the individual case in question.”

Introduction . Mr Hockton made it clear that this appeal is brought on the principal basis that the adverse findings of fact made by the Panel were wrong. In support of that general submission, the daunting nature of which he readily acknowledged, Mr Hockton relied heavily upon Dr Sharief’s professional and personal integrity (as evidenced mainly by his distinguished career and the high regard in which Dr Sharief is generally held by his professional colleagues), the absence of any complaint from any of the patients concerned, the lack of relevant expertise on the part of the Panel, the absence of any apparent motive on the part of Dr Sharief to do what he was alleged to have done and the fact that the allegations against Dr Sharief were almost entirely dependent on the evidence of one person, i.e. Sister Soudain. In paragraph 45 of his written skeleton argument, Mr Hockton summarised the essential nature of Dr Sharief’s case in this appeal in the following admirably succinct terms:

“It is recognised that the Court has often demonstrated some reluctance to interfere with findings of fact made by a disciplinary body such as the GMC. This case is somewhat unusual in that the panel made serious findings of fact against a well-regarded specialist in a field within which the panel had no relevant expertise, against the weight of expert opinion, and upon an insubstantial evidential basis. …”

Mr Hockton also submitted that the Legal Assessor’s advice to the Panel had been deficient in two respects. First, he suggested that the Legal Assessor failed to advise the Panel adequately in relation to its approach to the expert evidence. He contended that, in particular, the Legal Assessor failed to advise the Panel that there might be a range of opinion in relation to clinical issues and that, insofar as Dr Sharief acted in accordance with a reasonable body of opinion, his actions could not be deemed to be unacceptable (applying the Bolam test). Mr Hockton submitted that, given that this was a predominantly lay Panel dealing with matters outside its knowledge or experience, the Legal Assessor’s advice that it would be “unwise” to be an expert “in contradistinction to those who have actually given evidence” was insufficient (see Transcript, Day 11/80D-E) and that a much fuller Bolam type direction was required.

In my view, there is nothing in this first criticism of the Legal Assessor’s advice. I agree with Ms Gallafent that this was not a case where the expert evidence in respect of any of the allegations against Dr Sharief called for a Bolam type direction (assuming, but without deciding, that there can be medical disciplinary proceedings where such a direction would be appropriate). The circumstances relating to the allegations against Dr Sharief bore no resemblance at all to the circumstances in Maynard ~v~ West Midlands Regional Health Authority (1984) 1 WLR 634, to which Mr Hockton referred in support of his submissions. In any event, as will become apparent, I am satisfied that, to the extent that the Panel preferred the expert evidence called by the GMC to that called on behalf of Dr Sharief, there was a perfectly sensible and logical reason for it doing so. Furthermore, as it seems to me, it is also very noteworthy (as Mr Hockton readily acknowledged) that in response to the Legal Assessor’s enquiry, as to whether there were any respects in which Counsel thought that the advice he had given to the Panel was erroneous or whether there were any matters which he had not dealt with that he should have dealt with, Mr Hockton (who is a very experienced practitioner in this field) replied: “Sir, can I confirm that I have no observations on the Legal Assessor’s advice. …” (See Transcript, Day 11/82A)

Second, Mr Hockton referred to the following advice from the Legal Assessor (see Transcript, Day 11/78F-G):

“You must consider the case against and for Dr Sharief on each allegation separately. The evidence on the different allegations is different and therefore your findings need not be the same. If you have come to a decision of one allegation, whether in favour or against the doctor, you may of course take your conclusions into account in reaching your decision on another allegation. You must be careful, however, to avoid what might be called the “domino effect”, that is assuming that if one proposition is established the others are as well.”

Mr Hockton submitted that, on the facts of this case, the central part of that advice was wrong and/or insufficient because there was a clear risk that this part of this advice might result in the very “domino effect” against which the Legal Assessor then purported to warn the Panel.

Again, I am satisfied that there is nothing in this point. I agree with Ms Gallafent that the advice was correct in its terms, it was logically and clearly expressed and, thus, cannot be faulted (as Mr Hockton appears to have accepted at the time). Furthermore, as Ms Gallafent observed, it is clear from the terms of its written Determination that the Panel did consider each allegation separately (see page 2 of the Determination, Court Bundle 1/tab 6)

Ms Gallafent accepted that the main thrust of Dr Sharief’s case is that the Panel ought to have reached a different conclusion to that which it did based on the “disputed facts” and the expert evidence. However, Ms Gallafent understandably stressed that the fact the Court might, on the basis of the transcript, take a different view of the evidence and have reached a different view on the findings of fact is not sufficient for the appeal to succeed: see Meadow at paragraph 197, quoted above. Ms Gallafent submitted (correctly, in my view) that the Court should be slow to interfere with the Panel’s findings of fact that were reached after a lengthy hearing, involving a large number of witnesses.

Ms Gallafent emphasised that, having heard the evidence and having had the opportunity to see the demeanour of the witnesses, the Panel had preferred the evidence of other witnesses – in particular that of Sister Soudain – to that of Dr Sharief. Ms Gallafent submitted (correctly, in my view) that the Panel was plainly entitled to do so. She submitted that the Panel was also entitled to come to the conclusion, as it did, that it preferred the expert views of the GMC’s expert witness (Dr Hawkins) to that of Dr Sharief’s expert witness (Professor Bates) and, in noting that “there were significant differences between Professor Bates’ two reports in 2006 and 2008” (as to which, see below), the Panel had provided an appropriate basis for having done so. It was also Ms Gallafent’s submission that the Court should be exceptionally slow to interfere with findings of dishonesty on the part of Dr Sharief, based on his state of knowledge and explanation for his actions. I agree with that submission.

Ms Gallafent stressed that there is nothing unusual in a Panel of the GMC making serious findings against a well-regarded specialist in his field, nor in the fact that the Panel in question does not have specialist expertise in the particular field of medicine under consideration. I accept that submission. As Ms Gallafent pointed out, the relevant expert witnesses who give evidence before the Panel supply the necessary expertise. Ms Gallafent therefore submitted that there is nothing to distinguish this appeal from any other in which the Court has rightly accorded the appropriate degree of deference to the specialist panel. I agree.

With those introductory observations in mind, I now turn to consider the individual allegations with which this appeal is concerned.

(1) Patient CAG . In December 1999, Dr Sharief reclassified patient CAG as having RRMS, having earlier classified the same patient in June 1999 as suffering from SPMS. The reclassification in question was made in the context of the Rebif/Avonex clinical trial. In order to be eligible for that trial a patient was required to fulfil a number of inclusion criteria, including that they must have clinically definite or laboratory-supported definite RRMS: see paragraph 4.1.1.2 of the relevant protocol. It was common ground that if somebody is classified as having SPMS and is then later reclassified as having RRMS, it follows that either the latter classification or the earlier one is wrong.

Having heard and considered the evidence, the Panel made the following findings of fact with regard to patient CAG:

“Having classified Patient CAG in June 1999 as having secondary progressive multiple sclerosis (SPMS) you reclassified her in December 1999 as having relapsing remitting multiple sclerosis (RRMS). The Panel heard from both experts about the need for good evidence before reclassifying a patient from SPMS to RRMS. There was a history of SPMS throughout Patient CAG’s notes. The only evidence that you used to reclassify Patient CAG as suffering from RRMS was a clinically ambiguous letter from the patient’s general practitioner (GP). Until you received this letter, it was clear not only to yourself but to numerous other doctors that Patient CAG had SPMS. You told the Panel that you spoke on the telephone to the patient’s GP but you did not make a note of this significant and important conversation that led to your reclassifying the patient. Additionally you did not make any notes in the patient record about your decision, nor did you see the patient before you reclassified her.”

On this basis the Panel found paragraph 4(a) of the NoH proved, namely that there was no sufficient clinical evidence to justify the reclassification of CAG in December 1999 as suffering from RRMS from the earlier classification that she was suffering from SPMS.

Mr Hockton referred to and relied upon the arguments that he had addressed to the Panel with regard to this particular allegation (see Transcript Day 11/56ff). He submitted that the Panel’s adverse findings were wrong for the following broadly expressed reasons:

For her part, Ms Gallafent submitted (correctly, in my view) that Mr Hockton’s arguments missed the point. The allegation that the Panel found proved was that there had been insufficient clinical evidence to justify the reclassification of CAG from SPMS to RRMS in December 1999, the only clinical evidence being a clinically ambiguous letter from the patient’s GP dated 17^th December 1999. Whilst I have no doubt that the Panel had fully in mind all of the points made by Mr Hockton as summarised in paragraph 34(i) above, I agree with Ms Gallafent that none of them undermine the Panel’s essential conclusion in relation to this particular allegation that the GP’s letter was insufficient evidence to justify the reclassification in question. I also accept Ms Gallafent’s submission that it is noteworthy that it was not suggested by Mr Hockton that Dr Sharief’s reclassification of patient CAG was clinically justified solely by reference to her GP’s letter. On 21^st December 1999, without having seen patient CAG in the meantime, Dr Sharief wrote to her in the following terms:

“Just to let you know that I have received a letter from your GP Dr Cotton, and have in fact spoken to Dr Cotton about your MS. I am now satisfied that you have remitting rather than chronic progressive MS. Therefore, I am pleased to let you know that we will be able to invite you to participate in clinical trials at Guy’s Hospital that are aimed for people with relapsing remitting MS.”

However, there was no note or record of any such conversation between Dr Sharief and Dr Cotton. As it seems to me, it was therefore open to the Panel to conclude as it did, namely that the only evidence to justify Dr Sharief’s reclassification of patient CAG in December 1999 was the clinically ambiguous letter from her GP dated 17^th December 1999 and that this was insufficient. In my view, that was a finding that the Panel was entitled to make on the evidence

As Ms Gallafent observed, it was not until 10^th January 2000, three weeks after Dr Sharief had reclassified patient CAG, that he saw her and assessed her EDSS score as 5, having previously assessed it at 6.5 just over a month earlier. Although the Panel heard considerable evidence concerning the likelihood of the EDSS score of 5 being an accurate assessment, that assessment obviously did not form any part of the clinical evidence upon which Dr Sharief had reclassified patient CAG in December 1999 and the Panel was plainly correct to approach it on that basis. I agree with Ms Gallafent that Mr Hockton’s submissions on this aspect of the matter are therefore entirely beside the point.

I also agree with Ms Gallafent that there is no inconsistency between the Panel’s finding that paragraph 4(a) of the NoH was proved, but that paragraphs 4(b)(ii), 4(c) and 5(a) to (d) were not proved. As Ms Gallafent observed, paragraph 4(a) of the NoH was not concerned with whether, as a fact, patient CAG was suffering from RRMS at the time of the reclassification, but simply with whether there had been sufficient evidence available to Dr Sharief in December 1999 to justify that reclassification. As I have already stated, I am satisfied that this was a conclusion that the Panel was entitled to reach on the evidence. I agree with Ms Gallafent that there is nothing inconsistent with the Panel then going on to decide, as it did, that it could not be sure that in or around May 2000, when Dr Sharief actually admitted patient CAG to the clinical trial in question, she did not fulfil the criteria for inclusion on the trial. As it seems to me, that is not a surprising conclusion having regard to the limited nature of the finding under paragraph 4(a) of the NoH and in the light of the evidence as to how matters progressed subsequently, in particular that relating to Dr Sharief’s assessment of patient CAG in January 2000 and her apparently greatly improved EDSS score.

I therefore agree with Ms Gallafent that there is no basis for impugning the Panel’s findings in relation to patient CAG and I reject Mr Hockton’s submissions to the contrary effect.

(2) Patient EH . In May/June 2000, Dr Sharief also reclassified patient EH from SPMS to RRMS in the context of the Rebif/Avonex trial.

Having heard and considered the evidence, the Panel made the following findings of fact with regard to patient EH:

“Paragraph 7(a) [i.e. no clinical evidence to justify the reclassification of patient EH in or around May or June 2000] has been found proved. Having classified Patient EH in February 2000 as having SPMS you reclassified him three or four months later as having RRMS. You said in your evidence that your main basis for reclassifying Patient EH as suffering from RRMS rather than SPMS was that the patient had bounced back after receiving physiotherapy. The only record of the patient receiving physiotherapy was in 1997, three years before the reclassification. In the light of the background material, the Panel accepted Dr Hawkins’ evidence that there was no evidence to justify the reclassification of this patient.

Paragraph 7(b)(ii) has been found proved. Patient EH did not fulfil the criteria for inclusion in the study in that he did not have RRMS.

Paragraph 7(c)(i) and 7(c)(ii) [i.e. Dr Sharief knew or ought to have known that patient EH did not fulfil the criteria for inclusion] have been found proved. You had patient EH’s history in the material dating back to 1998 and were aware of that history. You knew the criteria in the trial protocol. You deliberately reclassified this patient when you knew that patient EH did not fulfil the criteria for inclusion on the trial.

Paragraph 8 has been found proved. The Panel has judged that your actions in admitting Patient EH onto the Rebif/Avonex trial were in appropriate, were unprofessional, were not in the best interests of your patient and were dishonest.”

In support of his submission that the Panel’s adverse findings of fact were wrong, Mr Hockton pointed out, much of the evidence in relation to patient EH overlapped with that concerning patient CAG, because both cases involved allegations of dishonest reclassification from SPMS to RRMS for the purpose of inclusion on the Rebif/Avonex trial. Mr Hockton therefore repeated and relied upon the points summarised in paragraph 34(i) above (“the factors of general application”). In addition, he made the following main specific points in relation to patient EH:

For her part, Ms Gallafent submitted that, so far as concerns the allegation with regard to the absence of any or sufficient clinical evidence to justify the reclassification of patient EH in May/June 2000 from SPMS to RRMS (paragraph 7(a) of the NoH), Mr Hockton’s submissions simply failed to address the central factor in the Panel’s clearly expressed reasoning and that the factors of general application did not undermine the Panel’s carefully expressed reasons for its conclusions.

As Ms Gallafent observed, Dr Sharief’s evidence to the Panel had been that his main reason for reclassifying patient EH was that he had “bounced back” after receiving physiotherapy: see Transcript Day 9/54F-G and see also Dr Sharief’s letter of 5^th June 2000 in which he stated: “in early 1999 [EH] complained of progressive decline in his leg strength, but he apparently bounced back following intensive physiotherapy and therefore the clinical history does not suggest secondary progression” (emphasis added). However, as Ms Gallafent pointed out, the Panel found Dr Sharief’s purported justification to be entirely unsustainable in the absence of any evidence that EH had actually received physiotherapy at any material time. I agree with Ms Gallafent that the Panel was clearly entitled to come to that conclusion on the evidence and that it was therefore also entitled to conclude that Dr Sharief did not have the necessary clinical evidence to justify the reclassification that he made in May/June 2000. In my view, it was also a conclusion that supported the Panel’s further conclusion that Dr Sharief had acted dishonestly.

As to whether patient EH did in fact fulfil the criteria for inclusion in the study, it is clear that the Panel preferred the evidence of Dr Hawkins to that of Professor Bates on this point. I am satisfied that the Panel were entitled to do so, having regard to Professor Bates’ significant change of view from that expressed in his 2006 report, where he stated (inter alia) that EH could be “defined as having progressive disease with relapses”, to that expressed in his evidence and in his 2008 report, where he said that patient EH “unquestionably” had RRMS “during the course of the trial” (see paragraphs 26 and 27 of the 2008 report and also Transcript Day 10/7H-11D).

I also agree with Ms Gallafent that, on proper analysis, it can be seen that the apparent concession made by Dr Hawkins (see paragraph 41(2) above) did not in any way undermine his conclusion that, having considered the case records and the trial protocol, patient EH did not satisfy the necessary inclusion criteria when admitted on to the trial by Dr Sharief.

As Ms Gallafent observed, it is clear that Dr Hawkins maintained his view that patient EH had been properly classified as having SPMS, rather than RRMS (see Transcript Day 6/29B-38C). Dr Hawkins opinion to that effect was primarily based on the available evidence as to patient EH’s medical condition before and up to the time of his recruitment on to the study. Plainly, as in the case of CAG, that was the relevant period of time. Thus, as Ms Gallafent submitted, the fact that Dr Hawkins accepted that Professor Bates’ view that patient EH was suffering from relapsing remitting disease during the course of the trial was a reasonable one, in no way undermined his own conclusion that, on the basis of the evidence as to patient EH’s medical condition before and up to the time of his recruitment on to the trial, patient EH was not suffering from RRMS but from SPMS.

Accordingly, for those reasons, I agree with Ms Gallafent that there is no proper basis for interfering with the Panel’s findings of fact in relation to patient EH and I reject Mr Hockton’s submissions to the contrary effect.

(3) Patient A . In April 2002, Dr Sharief admitted patient A on to a clinical study of the drug Natalizumab sponsored by Biogen. One of the criteria for inclusion on that study was there must be a “cranial MRI scan demonstrating lesion(s) consistent with MS” in respect of the patient in question (see paragraph 8.2(5) of the relevant Biogen protocol).

Having heard and considered the evidence, the Panel made the following findings of fact with regard to patient A:

“Paragraph 9(a) (as amended) [i.e. that patient A did not fulfil the criteria for inclusion in the study in that a cranial scan did not demonstrate cranial lesions consistent with MS] has been found proved. You reported [on 5^th April 2002] that there were a number of lesions (either 9 or 18) consistent with MS on the cranial MR scan which you saw [“the 2002 scan”]. Although the Panel accepted that the late Dr Bingham reported that there was [sic] one or two minute focal abnormalities on that MRI scan, it has accepted the evidence from Professor Yousry and Dr Butler that the scan did not demonstrate any cranial lesions consistent with MS.

The Panel has not considered the earlier MS scan used in the CORAL study, as you had not seen it and did not report on it.

Paragraphs 9(b)(i) and 9(b)(ii) have been found proved. You knew that Patient A did not fulfil the criteria for inclusion onto the Biogen study.

Paragraph 10 has been found proved. The Panel judged that your actions in admitting Patient A onto the Biogen Study when you knew that Patient A did not fulfil the criteria for inclusion were inappropriate, were unprofessional, were not in the best interests of the patient and were dishonest.”

Mr Hockton submitted that the only issue in this case was whether patient A had a single lesion consistent with MS on cranial scanning to justify inclusion on the Biogen study. It was his submission that the Panel’s findings (particularly the finding of dishonesty) were not only wrong but perverse in the light of the evidence.

In support of that submission, Mr Hockton referred to and relied upon the submissions that he had made to the Panel with regard to patient A (see Transcript Day 11/64-67). As well as the factors of general application, Mr Hockton also made detailed reference to the evidence (see paragraph 28(b) to (h) of his written skeleton argument) and emphasised the following main points: (i) although Dr Sharief had experience in reviewing scans, he was not a neuroradiologist and expert neuroradiologists often disagreed on the interpretation of scans; (ii) there had been no issue as to whether patient A actually had MS (this had been confirmed by four consultant neurologists); (iii) when a query was raised with regard to patient A’s 2002 scan (the scan upon which Dr Sharief reported in April 2002), a second report was obtained from Dr Bingham, who confirmed that the scan showed one or two focal abnormalities; (iv) all scans for the Biogen study were reviewed at the National Hospital for Neurology, Queen’s Square; (v) Professor Yousry, who interpreted the 2002 scan at Queen’s Square, stated in evidence that it showed one possible lesion consistent with MS; (vi) in any event, patient A had taken part in the earlier CORAL study and the scan taken for that study definitely showed 5 lesions consistent with MS; and (vii) as a result, at all material times Biogen were themselves satisfied that patient A met the inclusion criteria.

In short, as Ms Gallafent observed, Mr Hockton’s submissions in respect of patient A are essentially that: (i) in fact, patient A did fulfil the criteria for inclusion on to the Biogen study, as demonstrated by the earlier CORAL scan; (ii) the Panel ought to have accepted the evidence of Professor Yousry, Dr Bingham and Dr Butler to the effect that the 2002 cranial scan may have shown lesions consistent with MS; and (iii) Dr Sharief may have made an innocent mistake in interpreting the 2002 scan.

Ms Gallafent submitted that there was nothing in Mr Hockton’s first point. I agree with that submission for the reasons advanced by Ms Gallafent. As it expressly noted, the issue for the Panel concerned Dr Sharief’s actions with regard to the scan upon which he reported in April 2002, not the earlier CORAL scan, which he had never seen or considered at any material time. Thus the question raised by the allegation in paragraph 9(a) of the NoH, i.e. whether patient A did not fulfil the criteria for inclusion in the Biogen study in that a cranial scan (considered and reported upon by Dr Sharief) did not demonstrate cranial lesions consistent with MS, fell to be answered only by reference to the 2002 scan. Similarly, the question of whether Dr Sharief knew or ought to have known that patient A did not fulfil the relevant criteria (paragraph 9(b) of the NoH) fell to be answered by reference to Dr Sharief’s own state of knowledge at the material time, which was entirely based on the 2002 scan and not the CORAL scan.

I therefore agree with Ms Gallafent that Dr Sharief’s reliance on the CORAL scan and the fact that Biogen were apparently satisfied that patient A met the inclusion criteria as a result of what that scan showed are nothing to the point. As Dr Sharief himself rightly accepted in cross-examination (see Transcript Day 9/69C-D), the CORAL reports had nothing to do with his inclusion of patient A onto the study in question.

Accordingly, as Ms Gallafent observed, the essential issue with regard to the allegation in paragraph 9(a) of the NoH is whether the Panel erred in accepting the evidence of Professor Yousry and Dr Butler that the 2002 scan did not demonstrate any cranial lesions consistent with MS. In summary, that evidence was as follows:

There was therefore no evidence before the Panel that there were definite cranial lesions shown on the 2002 scan. Accordingly, as Ms Gallafent submitted, there is simply no basis for impugning the Panel’s conclusion that, based on what was shown on that scan, patient A did not fulfil the criteria for inclusion on to the study in question.

I also agree with Ms Gallafent that, in reality, Mr Hockton’s main complaint under this head is with regard to the Panel’s conclusion that Dr Sharief knew or ought to have known that patient A did not fulfil the criteria for inclusion (paragraph 9(b) of the NoH). To that end he relied on Dr Sharief’s lack of expertise in interpreting scans of this type and the evidence of Dr Butler that Dr Sharief’s report was capable of being the result of an innocent misinterpretation of the scan and that there were a number of areas of the scan that were open to misinterpretation (see Transcript, Day 4/37C-H).

However, as Ms Gallafent submitted, whether Dr Sharief’s interpretation of the 2002 scan was one involving an innocent mistake on his part was pre-eminently a question of assessment for the Panel, based on all the evidence before it. The fact that the misinterpretation of the scan was in principle capable of resulting from an innocent error does not mean that the Panel was bound to find that such was the case.

The Panel heard evidence from Sister Soudain about Dr Sharief’s unsatisfactory reaction when she raised the issue with him (see the summary of her evidence in paragraph 60 of Ms Gallafent’s written skeleton argument). The Panel also heard Dr Sharief’s own “wholly incredible” initial response to the allegation, which was to deny that his April 2002 report was in fact made for the purpose of assessing patient A’s eligibility for the Biogen study, but was for the purposes of “randomisation and safety” (see Transcript, Day 9/64A-G). Further, the Panel was entitled to take into account Dr Sharief’s “red herring” suggestion that Biogen had not relied on his report but upon the CORAL report (see Transcript, Day 9/68B-72A).

As Ms Gallafent observed, taking all these matters into account and weighing the credibility and reliability of Sister Soudain’s evidence as compared with that of Dr Sharief (based not only upon what they said but also upon their demeanour in saying it) the Panel was clearly entitled to reach the conclusion that Dr Sharief knew perfectly well that patient A did not satisfy the eligibility criteria by reference to the 2002 scan and that his actions in admitting him to the study in those circumstances were inappropriate, unprofessional, not in the best interests of the patient and dishonest.

For those reasons, therefore, I accept Ms Gallafent’s submission that there is no proper basis upon which this Court can or should interfere with the Panel’s findings of fact in relation to patient A.

(4) Patient E . In or around September 2002, Dr Sharief admitted patient E onto the Active Biotech trial. One of the criteria for inclusion in that trial was that the patient in question must have had at least one documented clinical or sub-clinical exacerbation (i.e. relapse) in the last year (or two in the last two years): see paragraph 7.3(e) of the relevant Active Biotech protocol.

Having heard and considered the evidence, the Panel made the following findings of fact with regard to patient E:

“Paragraph 12(a) [i.e. that patient E did not fulfil the criteria for inclusion in the Active Biotech trial in that she had not suffered relapses within the last 12 months] has been found proved.

Paragraphs 12(b)(i) and 12(b)(ii) [i.e. that Dr Sharief knew or ought to have known that patient E did not fulfil the criteria for the trial in question] has been found proved.

Paragraph 12(c) [i.e. that Dr Sharief had fabricated the letter dated 22 January 2001] has been found proved.

Paragraph 12(d) [i.e. that Dr Sharief’s claim to have spoken to E’s GP was false] has been found proved.

The Panel has noted that:

1.

there is no evidence of Patient E’s relapse in her GP records,

2.

there is no evidence of Patient E’s relapse in hospital records,

3.

there is no evidence of Patient E’s relapse in her diaries, and

4.

Patient E has no recollection of a relapse, although the Panel accepts that her memory has been affected by the disease.

When asked by Sister Soudain about Patient E’s lack of documented relapses you produced a letter that you said you had written to her GP following a telephone conversation you had with the GP about the relapse. This letter was dated 22 January 2001 although it has been accepted that this was an error and should be 22 January 2002. The letter was addressed to Dr Kuleratne, who was not at that time Patient E’s GP. Since April 2001 her GP had been Dr Craighill. Dr Craighill confirmed that there is nothing in Patient E’s records to show:

1.

that Patient E had either seen or spoken to Dr Craighill,

2.

that Dr Craighill had telephoned you about Patient E, or

3.

the letter you had sent to Patient E’s GP.

The Panel did not believe your account of the telephone call you say you received before you claimed to have written the letter in January 2002.

Paragraph 13 has been found proved. The Panel has found that you fabricated the letter, dated 22 January 2001, which purported to be to E’s GP, Dr Kuleratne, in which you falsely claimed to have spoken to E’s GP. The letter contained false information about a relapse. Patient E did not, therefore, fulfil the criteria for inclusion in the Active Biotech study in that she had not suffered documented relapses within the last 12 months. You knew that she did not fulfil the criteria for inclusion on the trial. Your actions in this regard were inappropriate, were unprofessional, were not in the best interests of your patient and were dishonest.”

Mr Hockton submitted that these findings were wrong, in that the evidential basis relied upon was insufficient. He pointed out that the allegations in this case centred on Dr Sharief’s letter of 22 January 2002 (mistakenly dated 2001), which the GMC alleged had been fabricated by Dr Sharief to provide evidence of a relapse by patient E within a timescale that satisfied the criteria for inclusion in the Active Biotech trial. Mr Hockton stressed that there was no direct evidence of any such fabrication by Dr Sharief and referred in detail to relevant parts of the evidence as summarised in paragraph 30 (b) to (i) of his written skeleton argument. He submitted that, having regard to the nature and quality of the circumstantial evidence, the Panel had been wrong to conclude that Dr Sharief fabricated the letter of 22 January 2002. In broad terms, in addition to relying on the factors of general application, Mr Hockton’s arguments in support of that submission were to the following effect:

I turn to deal specifically with Mr Hockton’s first submission, i.e. that the Panel erred in admitting patient E’s statement into evidence under rule 34 of the 2004 Rules.

So far as material, rule 34 of the 2004 Rules provides as follows:

“Evidence

34.

(1)

Subject to paragraph (2), the Committee or a Panel may admit any evidence they consider fair and relevant to the case before them, whether or not such evidence would be admissible in a court of law.

(2)

Where evidence would not be admissible in criminal proceedings in England, the Committee shall not admit such evidence unless, on the advice of the Legal Assessor, they are satisfied that their duty of making due inquiry into the case before them makes the admission desirable.

…”

On 27 March 2008 (Day 7 of the hearing before the Panel), Counsel for the GMC (Mr Kitching) applied to have patient E’s statement admitted into evidence because she felt unable to attend the hearing. The application was opposed by Mr Hockton. Having heard the submissions of Counsel for the parties and the advice of the Legal Assessor, the Panel ruled as follows (see Transcript, Day 7/18H-20C):

“Mr Kitching, you have made an application on behalf of the General Medical Council to read the witness statement of Patient E. You told the Panel that, until recently, Patient E was going to attend the hearing, but has recently decided that she could not cope with attending. Although she is suffering from multiple sclerosis, it is not contended that she is unfit to be a witness because of her bodily or mental condition.

You have drawn the Panel’s attention to the relevant provisions of the General Medical Council (Fitness to Practise) Rules Order of Council 2004, namely Rules 34(1) and 34(2), and to the provisions of the Criminal Justice Act 2003, dealing with the admission of hearsay evidence in criminal proceedings, section 114(1)(d), which allows a court to admit evidence if it is satisfied that it is in the interests of justice for it to be admissible.

Mr Hockton, on behalf of Dr Sharief, opposes the application and contends that it would not be in the interests of justice to admit the statement. He submits that it would not be fair to Dr Sharief, as Patient E could not be cross-examined; that Patient E has problems with recollection; and that she has refused to disclose her contemporaneous diaries. Mr Hockton submits that the factors of probative value and reliability are not satisfied in this case and that Rule 34(2) is not satisfied either.

The Panel has taken into account all of the matters it has heard and the submissions of you and Mr Hockton.

On the advice of the Legal Assessor, the Panel first considered whether the statement would be relevant to the proceedings. It determined it would be. The Panel next considered whether it would be fair to admit the statement. In doing so, it balanced the interests of the GMC and of Dr Sharief and determined that it would be fair to admit the statement. The Panel recognises, however, that it will have to judge the weight to be attached to Patient E’s evidence in the light of all the evidence and submissions.

The Panel is satisfied, in accordance with Rule 34(2) of its Procedure Rules that its duty of making due inquiry into this case makes the admission of the evidence desirable and the Panel accedes to your application. The Panel, therefore, did not find it necessary to decide whether the evidence would be admissible or not under the provisions of section 114 of the Criminal Justice Act 2003.”

Mr Hockton submitted that the Panel was in error in failing to decide whether the statement would have been admissible under the provisions of the Criminal Justice Act 2003 (“the 2003 Act”). He pointed out that it was common ground that the statement could only have been admitted in criminal proceedings under the provisions of section 114(1)(d) of the 2003 Act, which provides for the admissibility of the hearsay evidence in question if the court is satisfied that it is in the interests of justice that it should be admitted.

Mr Hockton stressed that if the Panel had given full and determinative consideration of section 114(1)(d) of the 2003 Act, this would have brought into play the non-exhaustive considerations of section 114(2) as well as other relevant considerations. He suggested that it was plainly unfair to admit patient E’s statement having regard to such considerations. He submitted that an important factor in the Panel’s proper consideration of whether it was fair (i.e. under rule 34 (1)) or desirable (i.e. under rule 34(2)) to admit the evidence in question is a determination by the Panel of how a criminal court would decide the issue of admissibility of the evidence in question in the light of these and any other relevant considerations. It was therefore his submission that the Panel’s failure to do so fatally undermined its decision that it was fair (under rule 34(1)) and desirable (under rule 34(2)) to admit the statement into evidence. Accordingly, he submitted, the Panel had fallen into error.

I agree with Ms Gallafent that there is no substance in Mr Hockton’s submissions on this aspect of the matter. The material terms of rule 34 of the 2004 Rules are perfectly clear. As it seems to me, there is nothing in the wording of rule 34 that supports the suggestion that an FTP Panel is required to decide how a criminal court would determine the question of the admissibility of the evidence in question as, in effect, a precondition of exercising its power under rule 34 to admit the evidence in question and I reject Mr Hockton’s submissions to the contrary effect.

Furthermore, having rightly decided that patient E’s statement was relevant, there is no reason to suppose that the Panel ignored the sort of considerations that appear in section 114(2) of the 2003 Act, when deciding that it was fair to admit the evidence under rule 34(1). On the contrary, the arguments that Mr Hockton addressed to the Panel had included detailed submissions with regard to section 114(2) and it is clear from the terms of its determination that the Panel took these fully into account before deciding that it was also fair to admit the statement. Accordingly, in my view there is no basis for impugning the Panel’s decision that, subject to rule 34(2), patient E’s statement could be admitted into evidence under rule 34(1).

Finally on this aspect of the matter, since it was not in a position to say whether patient E’s statement would have been admitted into evidence under section 114(1)(d) of the 2003 Act and thus have been admissible in criminal proceedings, the Panel then considered the position under rule 34(2) of the 2004 Rules, in effect on the assumed basis that the statement would not be admissible in criminal proceedings. In the circumstances of this case, I am satisfied that the Panel was right to do so. As it seems to me, it is clear from the terms of its ruling on the matter that the Panel gave proper consideration to the requirements of rule 34(2) and that, therefore, its decision to admit patient E’s statement into evidence under that sub-rule also cannot be faulted. Accordingly, for all the foregoing reasons, I reject Mr Hockton’s first submission in patient E’s case, namely that the Panel erred in admitting her witness statement into evidence under rule 34 of the 2004 Rules.

Turning now to the other points made by Mr Hockton, in my view it is important (as Ms Gallafent submitted) to set out in some detail the facts relating to patient E’s case that were not in dispute, as follows.

In the course of his evidence, Dr Sharief accepted that:

However, Dr Sharief suggested that either patient E may nevertheless have contacted Dr Craighill by telephone, and Dr Craighill telephoned him thereafter, or that he had been contacted by another GP about another patient that he mistook for patient E.

The Panel did not believe Dr Sharief’s account of the telephone call that he claimed to have received and to which he referred in the letter of 22 January 2002. I agree with Ms Gallafent that the Panel was entitled to do so. Apart from anything else, it was extremely unlikely that a patient suffering from a relapse of the sort described by Dr Sharief in the letter of 22 January 2002 would not have visited her GP, but merely spoken to him on the phone. I accept Ms Gallafent’s submission that, on the basis of all the circumstantial evidence, the overwhelming likelihood was that Dr Sharief had made up his account of the telephone call from patient E’s GP and had fabricated the letter in which it was recorded. As it seems to me, there is simply no proper basis upon which this court could interfere with the Panel’s finding of fact to that effect.

I also agree with Ms Gallafent that Mr Hockton’s points (2) to (4) (see paragraph 64 above) in no way undermine the Panel’s conclusion that Dr Sharief fabricated the letter of 22 January 2002, for the following reasons.

Accordingly, for all the foregoing reasons, I agree with Ms Gallafent that there is no proper basis for impugning the Panel’s findings in relation to patient E and I reject Mr Hockton’s submissions to the contrary effect.

(5) Patient RYP . On 18^th November 2002, Dr Sharief screened patient RYP as suitable for inclusion on to the BMS trial sponsored by Bristol Meyer Squibb. One of the criteria for inclusion in that trial was “no exacerbations of MS and clinically stable for 2 months prior to informed consent and during the run-in period, including the day of dosing” (see paragraph (5) of the relevant protocol).

Having heard and considered the evidence, the Panel made the following findings of fact with regard to patient RYP:

“Paragraph 14(b)(i) has been found proved. You knew that Patient RYP did not fulfil the criteria for inclusion on the trial as you had seen her six days before you screened her and you knew that she was not clinically stable throughout the two month period prior to signing informed consent and that she had a relapse in October which was clearly within that two month period.

Paragraph 15 has been found proved. Your actions in screening Patient RYP as suitable for inclusion when you knew that she did not fulfil the criteria for inclusion on the trial were inappropriate, were unprofessional, were not in the best interests of your patient and were dishonest.”

Mr Hockton acknowledged that it was accepted that both patients RYP and MM (see below) had been ineligible for inclusion in the BMS 188667 trial at the material time. He pointed out that neither patient actually took part in the trial because their ineligibility had been picked up at an early stage. Mr Hockton submitted that the evidence showed that such an error was common and understandable and that, in the light of that evidence and the factors of general application, the Panel’s adverse findings of fact in both cases to the effect that Dr Sharief knew that the patient in question was not eligible for inclusion in the BMS-188667 trial were clearly wrong.

For her part, Ms Gallafent pointed out that, in the case of patient RYP, Dr Sharief had screened her for the BMS trial on 18^th November 2002 and had recorded that she “satisfies all inclusion criteria”. On the same date patient RYP signed the consent form. Accordingly, in order to satisfy the inclusion criteria for the trial in question, patient RYP was required to have had no exacerbations of her MS and to have been clinically stable since 18^th September 2002.

However, as Ms Gallafent observed, patient RYP’s relevant medical history clearly showed that she did not satisfy the criteria for inclusion in the BMS trial. An entry in patient RYP’s hospital notes of 14 October 2002 recorded that she had suffered an exacerbation for which she was being reviewed. That relapse/exacerbation was also documented in a letter from Dr Sharief to patient RYP’s GP dated 7 October 2002, in respect of a clinic held on 1 October 2002, in which Dr Sharief stated that he had “reviewed this woman with MS as a matter of urgency because of a relapse last week”. Dr Sharief subsequently reviewed patient RYP again on 12 November 2002, just six days before the screening visit, and in a letter to her GP, dated 12 November 2002, noted that her frequent relapses indicated that her disease was still active.

As Ms Gallafent pointed out, the Panel heard Dr Sharief’s evidence in which he sought to explain his conduct in relation to patient RYP (see Transcript, Day 9/94E-103H). Dr Sharief admitted that, at the time, he had been under pressure from BMS to recruit patients. His explanation for not picking up the fact that patient RYP clearly did not meet the inclusion criteria ranged over the following various suggestions (i) that his mind was in turmoil as a result of the allegations that had been made against him at the time; (ii) that “eight weeks time needs only another 13 days (i.e. that patient RYP had been stable for nearly 2 months); (iii) that he could not remember the date on which the relapse had stabilised; and (iv) that her improving/recovering state following the relapse meant that she was stable (a suggestion that was emphatically rejected by Professor Bates: see Transcript, Day 11/34C).

I entirely agree with Ms Gallafent that, in the circumstances, the Panel was entitled to reject Dr Sharief’s explanation (as it did) and to find that his conduct was inappropriate, unprofessional, not in the best interests of the patient and dishonest.

Furthermore, I am satisfied that the Panel was entitled to conclude (as it plainly did in the case of both patients RYP and MM) that it did not accept Professor Bates’ evidence to the effect that such errors were common and understandable and did not amount to misconduct (see paragraph 32(b) of Mr Hockton’s written skeleton argument). As Ms Gallafent observed, given Dr Sharief’s extremely recent and detailed personal knowledge of the medical circumstances relating to both patient RYP and MM (see below) prior to their screening visits, the Panel was entitled to conclude that Dr Sharief’s error in each case was neither common or understandable, but amounted to misconduct.

For those reasons, therefore, I am satisfied that there is no proper basis for this court to interfere with the Panel’s findings of fact in respect of patient RYP and I reject Mr Hockton’s submissions to the contrary effect.

(6) Patient MM . On 11^th November 2002, Dr Sharief assessed patient MM also as being suitable for the BMS trial sponsored by Bristol Meyer Squibb. In addition to the inclusion criterion referred to above in the case of patient RYP (i.e. “no exacerbation of MS and clinically stable to 2 months prior to informed consent and during the run-in period, including the day of dosing”), paragraph (7) of the relevant BMS protocol included an exclusionary criterion that “…subjects who have been treated with a corticosteroid within 3 months prior to subject consent are not eligible for enrolment. This includes corticosteroid-inducing therapies”.

Having heard and considered the evidence, the Panel made the following findings of fact with regard to patient MM:

“Paragraphs 16(c)(i) (as amended) and 16(d)(i) have been found proved. The Panel found that you knew that Patient MM was not clinically stable for the two months prior to informed consent and that she had had exacerbations during that period. On 8^th November 2002 you knew that Patient MM had had intravenous steroids in early October, yet you screened MM as suitable on 11 November 2002. You knew that MM did not fulfil the inclusion criteria for the trial and you knew that MM fulfilled the criteria for exclusion from the trial.

Paragraph 16(f)(i) has been found proved. You knew the protocol had been updated as you signed the amendment to the protocol.

Paragraph 17 has been found proved. You knew that MM did not fulfil the inclusion criteria for the trial, you also knew that she did fulfil the criteria for exclusion and that the protocol had been updated. Your actions in screening MM as being suitable for inclusion on the BMS-188667 trial were therefore inappropriate, unprofessional, not in the best interests of your patient and were dishonest.

Paragraph 18 has been found proved. You deliberately sought to justify your actions to Professor Hughes, the Head of your Department, by reference to an outdated trial protocol. That was misleading, unprofessional and dishonest.”

As I have already stated, see paragraph 81 above, Mr Hockton made it clear that it was accepted that patient MM was not eligible for inclusion in the BMS trial. As in the case of patient RYP, Mr Hockton submitted that, having regard to the factors of general application and the evidence relating to patient MM, the Panel should have accepted that Dr Sharief had made an innocent mistake, that the Panel was therefore wrong to have concluded that he knew that patient MM was not eligible for inclusion in the trial in question and thus wrong to have found that he was guilty of misconduct. However, it is to be noted that Mr Hockton did not advance any specific submissions directed at the Panel’s finding in relation to paragraph 18 of the NoH.

For her part, Ms Gallafent pointed out that the Panel found that Dr Sharief knew that patient MM did not meet the inclusion criteria and that she met the exclusion criteria in circumstances where Dr Sharief’s screening visit on 11 November 2002 read: “signed consent form. Satisfies all inclusion criteria. Had steroid therapy 2 months ago [therefore] may not satisfy treatment criteria”. Furthermore, Dr Sharief had reviewed patient MM five days earlier on 6 November 2002 and, in a letter to patient MM’s GP dated 8 November 2002, he expressly referred to her admission to hospital for intravenous steroids following a clinical relapse and her subsequent discharge on 2 October 2002.

Dr Sharief’s evidence to the Panel in relation to patient MM was similar to that which gave in respect of patient RYP, namely that his error was made in good faith since patient MM’s relapse fell within the three month period by only three days and that the day on which the screening visit occurred was “a big haze to me” as a result of the allegations that had been made against him (see Transcript, Day 9/102F-107A).

Mr Hockton also pointed out and relied upon the fact that Sister Soudain herself did not pick up on the fact that patient MM was ineligible. Mr Hockton referred to an email from Dr Sharief to Sister Soudain dated 6 November 2002, in which Dr Sharief referred to the fact that patient MM had been admitted to hospital in early September for treatment by intravenous steroids. Nevertheless, Sister arranged for patient MM to have a screening interview. In the course of her evidence, Sister Soudain readily admitted that she had made a mistake in doing so. However, I accept Ms Gallafent’s submission that the fact that Sister Soudain herself made such an error does not excuse or detract from Dr Sharief’s subsequent conduct in screening patient MM as eligible for inclusion in the trial in question.

So far as concerns Dr Sharief’s own evidence (see paragraph 91 above), the Panel rejected his explanation for his conduct. In my view, the Panel was entitled to do so and, in the light of its findings of fact, entitled to conclude that Dr Sharief’s conduct was inappropriate, unprofessional, not in the best interests of the patient and dishonest.

Accordingly, for all the foregoing reasons, I accept Ms Gallafent’s submission that there is no proper basis for impugning the Panel’s findings in relation to patient MM and I reject Mr Hockton’s submissions to the contrary effect.

(7) The Forgery of Dr Douglas’ signature . It was alleged that Dr Sharief had forged the signature of Dr Douglas on a Sub-Investigator’s “Representations and Warranties” document dated 10 October 2001 relating to the Biogen Study C-1801. Dr Sharief denied the allegation. Mr Hockton submitted that, although Dr Douglas confirmed in evidence that the signature on the document in question was not his, there was no or no sufficient evidence to prove that Dr Sharief had forged the signature in question.

Having heard and considered the evidence relating to the alleged forgery, the Panel made the following findings of fact:

“Paragraph 19 (as amended) has been found proved. The Panel has accepted Sister Soudain’s evidence that you nominated Dr Douglas as Sub-Investigator. Sister Soudain did not know Dr Douglas and would not have had the authority to nominate him as Sub-Investigator. Also, you admitted during cross-examination that it was you who nominated him for this role. The Panel accepted her evidence that she spoke to you after recognising your handwriting on the document, and you admitted to her that you had signed Dr Douglas’ name on the document because Dr Douglas was out of the country.

Paragraph 20 has been found proved. Your actions on or around 10 October 2001, in forging the signature of Dr Douglas on the representations and warranties document were misleading, unprofessional and dishonest.”

It was common ground that the signature on the form in question had not been written by Dr Douglas and Dr Sharief appears to have accepted that, realistically, only he and Sister Soudain could have been responsible for having forged the signature (see Transcript, Day 9/115B-C). However, both denied having forged the signature on the document in question.

As it seems to me, in rejecting Dr Sharief’s evidence that he had not forged the signature in question, the Panel was clearly strongly (if not overwhelmingly) influenced by what it understood to have been an admission by Dr Sharief, during the course of a conversation that he had had with Sister Soudain in around October 2001, that he had written Dr Douglas’ signature on the document in question because Dr Douglas was out of the country; and the Panel expressly purported to accept Sister Soudain’s evidence to that effect (see the Panel’s findings quoted above).

However, it is quite clear from the transcript of Sister Soudain’s evidence about her conversation with Dr Sharief, that she was not referring to the “Representations and Warranties” document which was the subject of the allegation in paragraph 19 of the NoH, but to an entirely different document (an “FD 1572” financial disclosure form). In the course of Sister Soudain’s evidence in chief, Mr Kitching referred her to the Representations and Warranties document and Sister Soudain replied to his questions as follows (see Transcript, Day 2/56G-57C):

“Q. All right. Do you know who Dr Douglas is?

A. I have never met him. I believe he was a registrar at St Thomas’.

Q. Do you know where he was working in October? If you do not, then – October 2001?

A. All I know is that Dr Sharief had said that he was out of the country.

Q. Do you know who nominated him as sub investigator?

A. Dr Sharief.

Q. I think you spoke to Dr Sharief about the signature that we can see on this page?

A. I had spoken to him about an FDA 1572 financial disclosure form, which also had a similar signature on it, which I believed was not Dr Douglas’s.

Q. What did he say when you spoke to him?

A. Well, I said to him, “Look, this is clearly your handwriting, Mohammad. That is a forgery and I am not prepared to submit this to the FDA.” He said to me, “What could I do? He is out of the country. It is just a bit of paper. It does not matter.”

Q. Just to get it clear, you were speaking to him about two signatures on two different documents at that time?

A.

I was speaking to him only about one signature on the FDA 1572.”

I quite accept Ms Gallafent’s submission that the Panel was entitled to prefer the evidence of Sister Soudain to that of Dr Sharief. However, it is clear that the Panel misunderstood Sister Soudain’s evidence about her conversation with Dr Sharief. She made it perfectly clear that the conversation was solely concerned with Dr Douglas’ apparent signature on another and completely different document. Importantly, Sister Soudain did not give evidence that Dr Sharief admitted having written Dr Douglas’ signature on the relevant document. In my view, the Panel’s misunderstanding of Sister Soudain’s evidence fatally undermines its main reason for concluding that Dr Sharief had forged Dr Douglas’ signature on the representations and warranties document – because there was simply no evidence that he had ever admitted having done so, as the Panel erroneously thought there was.

Furthermore, if the Panel had properly understood and (as no doubt would have been the case) accepted Sister Soudain’s evidence that Dr Sharief had admitted having written Dr Douglas’ signature on another and entirely different document, in my view that would not be sufficient for a proper inference to be drawn that he had forged Dr Douglas’ signature on the relevant document. I therefore accept Mr Hockton’s submission that Sister Soudain’s evidence and the remaining circumstantial evidence (see the summary in paragraph 34 of his written skeleton argument) is insufficient to support the Panel’s findings of fact under paragraphs 19 and 20 of the NoH which must, therefore, be quashed.

(8) Signature by Sister Soudain . The final allegation that the Panel found proved (paragraph 21 of the NoH) was in relation to an email dated 18 April 2002, from Dr Sharief to Sister Soudain, in which he asked her to append a signature purporting to be his own on an internal King’s College research grant form, as follows: “Please could I ask you to print them out and sign them on my behalf? Any old scribble will do. This is not a forgery, as I have completed the forms myself and am giving you permission to sign them to avoid delays.” Having heard and considered the evidence (in particular that of Sister Soudain and Dr Sharief), the Panel found that Dr Sharief’s action in so doing was misleading, inappropriate, unprofessional and dishonest.

As I have already indicated (see paragraph 12 above) Mr Hockton only took issue with the Panel’s finding of dishonesty in relation to paragraph 21 of the NoH. Mr Hockton pointed out that Sister Soudain did attach Dr Sharief’s signature to the document as requested. He also stressed that the evidence was that the information contained in the documents was entirely accurate and that the sponsor had raised no issue/query. Dr Sharief’s evidence was that he had been in America when he got the request for the completed documents that resulted in his email to Sister Soudain, that the Dean had subsequently countersigned them without objection and that Dr Sharief had been under considerable pressure as the result of urgent phone calls from the Health Trust for the completed documents, because the Health Secretary wanted the studies to begin. Dr Sharief accepted that he had been very naïve in acting as he did, but denied any dishonest intention. Mr Hockton submitted that, in the light of all the evidence (including the factors of general application), the Panel was wrong to conclude that Dr Sharief had acted dishonestly.

However, as Ms Gallafent submitted, it is perfectly clear that Dr Sharief did intend that an important research grant document should be submitted that purported to have been signed by him personally in circumstances where it was not. As such, as Ms Gallafent observed, it was open to the Panel to decide that Dr Sharief’s intention was to deceive the recipient of the document and others into believing that he himself had signed it. Furthermore, in my view, the Panel was entitled to regard as clear evidence of that intention to deceive the fact that Dr Sharief did not simply ask Sister Soudain to “p.p.” the document on his behalf. As Ms Gallafent observed, it was not correct to describe the document as entirely accurate because, on its face, it purported to have been signed by Dr Sharief when it had not been. As for the fact that the sponsor raised no issue/query, I agree with Ms Gallafent that this is nothing to the point, because there was no evidence that the falsity of the signature had ever been brought to its attention.

In my view, there was thus sufficient evidence upon which the Panel could properly conclude that Dr Sharief acted dishonestly in requesting Sister Soudain to append his signature to the document in question. I therefore accept Ms Gallafent’s submission that there is no proper basis for impugning the Panel’s conclusion to that effect in relation to the matters alleged in paragraph 21 of the NoH and I reject Mr Hockton’s submissions to the contrary effect.

This appeal is allowed to the limited extent indicated in paragraph 102 above, i.e. that, for the reasons given, the Panel’s findings of fact in relation to paragraphs 19 and 20 of the NoH must be and are hereby quashed. For the reasons given above, the appeal in respect of all the other findings of fact is dismissed. I will hear the further submissions of Counsel (if any) with regard to any further resulting aspect of this appeal (i.e. impairment and/or sanction), any consequential applications and with regard to the appropriate form of order.