“We believe that almost every statement made about the design, conduct and reporting of the neonatal … [CNEP] trial in the Griffiths report was ill–informed, misguided or factually wrong.”
“… We think you have missed the point of our article. This was not to say whether the CNEP trial was well conducted, but whether the Griffiths Inquiry was well conducted. Had it been, the report of the Inquiry would not contain the factual errors is does contain. … We have not concluded that there were no irregularities in the way the CNEP study was undertaken. We could not possibly reach such a conclusion without even knowing what criticisms some families raised with the panel, or examining relevant papers to which we have not had access. We have seen documents that you have not seen, you have seen documents that we have not seen. What remains extraordinary is that the Griffiths panel apparently never sought, let alone examined, much of the relevant contemporaneous documentation.”
“1. In conduct cases the PPC’s task is to decide whether, in its opinion, there is a real prospect of serious professional misconduct being established before the PCC. Serious professional misconduct may be considered in the context of conduct so grave as potentially to call into question a practitioner’s registration whether indefinitely, temporarily or conditionally. 2. The “real prospect” test applies to both the factual allegations and the question whether, if established, the facts would amount to serious professional misconduct. It reflects not a probability but rather a genuine (not remote or fanciful) possibility. It is in no-one’s interest for cases to be referred to the PCC when they are bound to fail, and the PPC may properly decline to refer such cases. On the other hand, cases which raise a genuine issue of serious professional misconduct are for the PPC to decide. 3. … in performing its task the PPC: (1) should bear in mind that the standard of proof before the PCC will be the criminal standard (beyond reasonable doubt); (2) is entitled to assess the weight of the evidence; (3) should not, however, normally seek to resolve substantial conflicts of evidence; (4) should proceed with caution (given that, among other considerations, it is working from documents alone and does not generally have the benefit of [a] complainant’s response to any reply to the complaint submitted on behalf of the practitioner); (5) should proceed with particular caution in reaching a decision to halt a complaint when the decision may be perceived as inconsistent with a decision made by another public body with medical personnel or input (for example, an NHS body, a Coroner or an Ombudsman) in relation to the same or substantially the same facts and if it does reach such a decision, should give reasons for any apparent inconsistency; (6) should be slower to halt a complaint against a practitioner who continues to practise than against one who does not; (7) if in doubt, should consider invoking Rule 13 of the Procedure Rules and in any event should lean in favour of allowing the complaint to proceed to the PCC; and (8) should bear in mind that, whilst there is a public interest in medical practitioners not being harassed by unfounded complaints, there is also a public interest in the ventilation before the PCC in public of complaints which do have a real prospect of establishing serious professional misconduct.” (1) should bear in mind that the standard of proof before the PCC will be the criminal standard (beyond reasonable doubt); (2) is entitled to assess the weight of the evidence; (3) should not, however, normally seek to resolve substantial conflicts of evidence; (4) should proceed with caution (given that, among other considerations, it is working from documents alone and does not generally have the benefit of [a] complainant’s response to any reply to the complaint submitted on behalf of the practitioner); (5) should proceed with particular caution in reaching a decision to halt a complaint when the decision may be perceived as inconsistent with a decision made by another public body with medical personnel or input (for example, an NHS body, a Coroner or an Ombudsman) in relation to the same or substantially the same facts and if it does reach such a decision, should give reasons for any apparent inconsistency; (6) should be slower to halt a complaint against a practitioner who continues to practise than against one who does not; (7) if in doubt, should consider invoking Rule 13 of the Procedure Rules and in any event should lean in favour of allowing the complaint to proceed to the PCC; and (8) should bear in mind that, whilst there is a public interest in medical practitioners not being harassed by unfounded complaints, there is also a public interest in the ventilation before the PCC in public of complaints which do have a real prospect of establishing serious professional misconduct.”
“The Committee considered that, as Professor Southall was not involved in any clinical care, any sustainable allegations must relate to the design of the trial and its overall conduct. The Committee was of the view that, in the light of the Hull report, the Hey and Chalmers article, and the fact that the subsequent paper was published in Paediatrics and therefore subject to peer review, the trial had been properly conducted. … The Committee carefully considered all the information before it. It decided that the allegations had no real prospect of being proved to the required standard. Moreover, the Committee was of the opinion that where there might be some evidence in support of the allegations, they would not, if proved, reach the threshold for serious professional misconduct.”
“The case for the defence, which was to be found in the representations of the doctors … and in the Hey and Chalmers article, in Professor Griffiths’ reply and in the Hull report … [and] The North Staffordshire consent audit and the Midland Health Consultancy Network Report … referred to … in Professor Hull’s Report.”
“… Paragraph 2 is framed in terms which are, if anything, more favourable to the claimant. Certainly, by the use of the words ‘cases which raise a genuine issue of serious professional misconduct are for the PCC to decide’, the PPC was given guidance helpful to the complainant about what would constitute a real as opposed to a fanciful prospect of success.”
“Mr Wise suggests that permission should be granted so as to enable the correct test to be formulated. I am afraid that I regard the application in this respect as misguided. There is nothing to examine. The test is clear and, apart from an exercise in semantics, Mr Wise agrees with it. …”
“73. The PPC was not to attempt to resolve the questions raised on both sides, but to consider the materiality and weight of the evidence in particular and in the round. It was then required to pose the question whether so much of that which had a reasonable prospect of proof would raise a real prospect that serious professional misconduct had occurred. The judgment of what might in the context of this case amount to serious professional misconduct was a matter for the expertise of the Committee.” “76. It seems to me that the PPC was entitled to point out to the complainants the nature of the material which tended to undermine the complaints made. It was not necessary, and would have been inappropriate to engage in a line by line recitation of the complaints, but it was appropriate to weigh up the complaints on the one hand and the body of evidence which could, should the matter proceed, be deployed on behalf of the doctors on the other. In reaching their decisions, the PPC of course had to distinguish between those facts which were incontrovertible and those which were controversial, and therefore the subject for the deployment of conflicting evidence. As to conflicting evidence, the PPC were required to consider not the result of the conflict, but the realistic prospects for the result of conflict.” “77. Finally, the PPC had to consider whether that which appeared incontrovertible and that which realistically remained in issue gave rise to a real prospect of a finding of serious professional misconduct. That is the process in which it seems to me the PPC not only said it was engaged, but was in fact engaged, when it expressed itself in its decision letter of12th March 2004 . …”
“72. … the case for the prosecution, as it were, was comprised in Mr and Mrs Henshall’s affidavits and documents, purportedly supported, including the Griffiths report. The case for the defence was to be found in the representations of the doctors who made them and in the Hey and Chalmers article, in Professor Griffiths’ reply and in the Hull report. The North Staffordshire consent audit and the Midland Health Consultancy Network Report were referred to, particularly in Professor Hull’s Report. 74. … One of the reasons why I have referred to the evidence in more detail than otherwise I would, is to demonstrate its significance to the deliberations performed by the Committee. Professor Griffiths made it clear that the purpose of his inquiry was not to make a judgment upon the professional competence and behaviour of the doctors by the standards of the time, but ‘… to look into general framework for both the approval and monitoring of clinical research projects in North Staffordshire’. He revealed, as I have read from his response to Hey and Chalmers that he had received submissions from several expert witnesses of eminence that the trial conducted by the doctors was probably no different from that in many other trusts at the time. He was looking to the question whether, in the light of experience, a national framework was required. 75. It was abundantly clear that, in any event, for one reason or another, Professor Griffiths had not been provided with all the material required to make an informed judgment about the CNEP trial in North Staffordshire. The material was described by Hey and Chalmers and listed in the appendices to their article. Professor Hull also had the advantage of access to documents not seen by others, which caused him not to share those others’ misgivings, as he put it.”
“Where the Committee have decided not to refer a case for inquiry no complainant, informant or practitioner shall have any right of access to any documents relating to the case submitted to the Council by any other person, nor shall the Committee be required by a complainant, informant or practitioner to state reasons for their decision.”
“(4) The Act and Procedure Rules do not, of course, preclude the voluntary disclosure of doctors’ responses to complainants. a) But, as Mr Justice Lightman also noted in Toth … the doctor must consent to such disclosure. It is, after all, his document/information which would be revealed. b) In the present case, it was made clear to the GMC (explicitly, firmly and consistently) by Professor Southall’s solicitors that he did not consent to the disclosure of any of his responses to the Claimant (or any other claimant). (5) In those circumstances, the GMC was neither required nor entitled to give the disclosure sought by the Claimant.” a) But, as Mr Justice Lightman also noted in Toth … the doctor must consent to such disclosure. It is, after all, his document/information which would be revealed. b) In the present case, it was made clear to the GMC (explicitly, firmly and consistently) by Professor Southall’s solicitors that he did not consent to the disclosure of any of his responses to the Claimant (or any other claimant). (5) In those circumstances, the GMC was neither required nor entitled to give the disclosure sought by the Claimant.”
“Whilst the GMC is not bound to make such disclosure to a complainant of material put before the screener, it is not precluded by the Rules from doing so and accordingly it is free to do so, at any rate unless precluded from doing so by a confidentiality obligation owed to the party supplying the material. The issue raised is whether, as a condition of voluntarily making disclosure to Mr Toth of confidential medical evidence relating to the health of …[the respondent doctor], and accordingly of material which …[the doctor] has every reasonable ground to wish should remain confidential, the GMC can insist on Mr Toth providing an undertaking of confidentiality. … if the GMC voluntarily in accordance with the principles of fairness decides that in principle disclosure should be made, it is entirely free to impose conditions which likewise accord with the principles of fairness. In my view, in insisting on respect being afforded by Mr. Toth for the confidentiality of the medical evidence relating to the … doctor’s health, the GMC is acting entirely properly. To do otherwise would be calculated to discourage practitioners from submitting relevant, but confidential, material to the GMC for consideration by the screener. …”
“… in the interests of fairness to all parties, any comments which you submit concerning material relevant to … the Henshalls’ … complaint, should be disclosed to the complainants by the GMC. This is in accordance with our procedures, which make provision for both the complainant(s) and the doctor(s) to be informed of each other’s representations, thus enabling both ‘sides’ to comment upon the other’s representations. You have so far prevented this process from happening since you have not provided consent to the disclosure of your submission to complainants. I would ask you to reconsider this decision and if necessary submit an amended version of the original submission, which you agree to the GMC disclosing to the complainants.”
“… The Rules do not contemplate the disclosure of the doctor’s response at the PPC stage. However, Rule 16 reposes a discretion in the PPC, and the policy to which Lightman J referred states the circumstances in which that discretion will be exercised to withhold disclosure.”
“59. The issue is not whether the documents would have been used for such a purpose, and the claimant was prepared to give an undertaking, but whether Professor Southall and the PPC had proper grounds to fear that they would be used for that purpose. 60. … Unfairness in this context means unfairness to the complainant. There may be circumstances in which the complainant should, notwithstanding, have been given the opportunity to comment upon, for example, an assertion of fact about which she might not otherwise know. I have in mind, by way of further example, that, where an assertion of fact is made to which the complainant is the only one who may be able to provide useful evidence as to the truth or falsity of that factual assertion, considerations of fairness may demand that she has the opportunity comment upon it. However nothing is revealed in the decision letter which indicates that such a situation might have existed here. On the contrary, Professor Southall’s defence to the criticism made publicly by the parents in 1997 and since has itself been publicised by the means of the Hey and Chalmers report … 61. It is clear to me that there is no reasonable prospect that Mrs H[enshall], whose knowledge of the case is encyclopaedic, has been deprived of a meaningful opportunity to present her complaint against Professor Southall. 63. … it is my view that the discretion has been exercised properly and that, in the result, no unfairness has conceivably resulted. ”
“We believe that almost every statement made about the design, conduct, and reporting of the neonatal continuous extrathoracic pressure (CNEP) trial in the Griffiths report was ill informed, misguided or factually wrong.”
“4.1.1 The Review Panel was given evidence of individual failures in the way that the research was carried out but as far as the Review Panel can tell the governance systems were broadly in line with Department of Health guidance that existed at the time. That guidance, however, left scope for considerable latitude in the way that individual projects were managed. This in turn left scope for the inadequacies that the Review has identified to go undetected and uncorrected. 4.1.2 The Review Panel found that research governance, including practice and policies in individual trials, as well as in the Trust generally in the period to which the Review relates did not match what would now be considered best practice. The original complaint made by Mr and Mrs Henshall and which led to the Review has resulted in valuable improvements being made.”