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Cite as: [2005] EWCA Civ 1520

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		Neutral Citation Number: [2005] EWCA Civ 1520
		Case No: C1/2004/2706

IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
THE HONOURABLE MR JUSTICE PITCHFORD
CO/2856/2004

Royal Courts of Justice
Strand, London, WC2A 2LL

13/12/2005

B e f o r e :

THE RIGHT HONOURABLE LORD JUSTICE AULD
THE RIGHT HONOURABLE LORD JUSTICE SEDLEY
and
THE RIGHT HONOURABLE LORD JUSTICE JONATHAN PARKER
____________________

Between:

	DEBORAH HENSHALL	Appellant
	- and -
	THE GENERAL MEDICAL COUNCIL PROFESSOR DAVID SOUTHALL DR ANDREW SPENCER DR MARTIN SAMUELS	Respondent Interested Parties

____________________

Mr Philip Havers QC and Mr Ian Wise (instructed by Irwin Mitchell) for the Appellant
Mr Mark Shaw QC (instructed by Field Fisher Waterhouse) for the Respondent
Mr Andrew Kennedy (instructed by Hempsons) for the 1st Interested Party
Miss Mary O'Rourke (instructed by Radcliffes Le Brasseur & Co.) for the 2nd and 3rd Interested Parties
Hearing dates : 27th & 28th June 2005
____________________

HTML VERSION OF JUDGMENT
____________________

Lord Justice Auld:

Introduction

This is an appeal and substantive hearing of an application by permission of Laws LJ of the appeal of Deborah Henshall against the refusal on 15^th December 2004 by Pitchford J. of her application to claim judicial review.

The application concerns complaints made by Mrs Henshall and her husband to the General Medical Council ("the GMC") against three doctors in 1997 alleging serious professional misconduct by them in 1992. At all material times the disciplinary procedures governing such complaints were contained in a statutory scheme prescribed by the Medical Act 1983 ("the 1983 Act") and the General Medical Council Preliminary Proceedings Committee and Professional Conduct Committee (Procedure) Rules 1988 ("the 1988 Rules"). Under that scheme, there were two preliminary stages to the consideration of a complaint, an initial check by a GMC "screener", largely as to formalities, and a second, somewhat more rigorous check, by the Preliminary Proceedings Committee ("the PPC"), as to whether they ought to refer the complaint referred to them by the screener to the Professional Conduct Committee ("the PCC"), for determination of the complaint. In November 2004 that three tier scheme was replaced by a two tier scheme by the General Medical Council (Fitness to Practise) Rules Order of Council 2004 ("the 2004 Order"). Since the decision under challenge in this case was made in February 2004, the old, not the new, scheme, governs it.

Mrs Henshall challenges a decision of the PPC of 26^th February 2004, communicated to her and her husband by letter of 12^th March 2004, not to refer her complaints against three registered medical practitioners, Professor David Southall, Dr Martin Samuels and Dr Andrew Spencer to the PCC. If successful in that challenge she seeks referral of the matter straight to the PCC or remittal to the PPC or its nearest successor under the GMC's new statutory scheme.

In the early 1990s those doctors had been involved in a clinical trial of a treatment for premature babies with breathing difficulties at the North Staffordshire Maternity Hospital in Stoke ("the Hospital"). The treatment was known as Continuous Negative Extrathorasic Pressure Ventilation or 'CNEP'. Mrs Henshall had two premature babies both of whom were included in the CNEP trial. The first, Stacey, died 60 hours after her birth and the second, Sofie, was subsequently found to have cerebral palsy.

Mrs Henshall complains about the integrity of the CNEP trial, which was designed and established by Professor Southall and Dr Martin Samuels, and about the supervision and conduct of it at the hospital, for which Dr Spencer was responsible. She and her husband first complained in 1997, but the PPC did not make its decision until, as I have said, early 2004. In summary, the PPC concluded: 1) that the majority of the complaints were unsupported by any evidence; 2) that the remainder had some evidential support, but insufficient to indicate a real prospect of establishing them factually or of the emergence of further sufficient evidence to do so; and/or 3) that, such allegations that might be provable by existing or further evidence had no real prospect of amounting to serious professional misconduct.

The issues

The application raises the following issues:

i) whether the PPC identified and applied the correct legal test in deciding not to refer Mr and Mrs Henshall's complaints to the PCC;

ii) whether the PPC wrongly declined to disclose to Mr and Mrs Henshall written responses to their complaints of Professor Southall communicated to the PPC; and

iii) whether the PPC wrongly relied in reaching its decision on an article in the British Medical Journal ("BMJ") by Dr Edmund Hey and Sir Iain Chalmers ("the Hey & Chalmers Article"), highly critical of a report commissioned by the NHS Executive by a panel headed by Professor Rob Griffiths ("the Griffiths Report").

The facts

In 1992 Mrs Henshall gave birth to her two daughters, Stacey and Sofie, at the North Staffordshire Royal Infirmary, Stacy on 12^th February 1992, and Sofie, on 14^th December 1992.

Both babies were born prematurely and received CNEP treatment as part of the clinical trial designed and overseen by Professor Southall, a consultant paediatrician. Dr Samuels, also a consultant paediatrician, had worked with Professor Southall on a protocol for the trial. Dr Spencer was the consultant paediatricial/neonatologist with clinical responsibility for children recruited to the CNEP trial in North Staffordshire and was also lead researcher at the North Staffordshire Maternity Hospital. The trial had been put before and approved by the local ethics committee.

Mr and Mrs Henshall claimed not to have known that their daughters had been given CNEP treatment until told a long time afterwards, in December 1996. As a result of that information, in May 1997 they complained to the GMC about the three doctors' involvement in and/or conduct of the trial treatment, alleging, in each case, serious professional misconduct. They maintained that the doctors should not have undertaken it, that they and other parents whose babies had been similarly treated had not had an opportunity to make an informed choice about it, in particular, they had not been told of the risks associated with it.

Mr and Mrs Henshall's complaints, which have been helpfully summarised by Mr Mark Shaw QC, counsel for the GMC, and Mr Andrew Kennedy, for Professor Southall, consisted of the following:

1) deception of the local ethics committee about the benefits and safety of the CNEP technique in order to secure approval and funding for the trial;

2) performing unnecessary caesarean sections specifically in order to ensure an adequate supply of premature neonatal babies for the trial;

3) forging Mrs Henshall's signature on the consent forms for entering her daughters into the trial, her consent not having been given;

4) in the alternative to 3), entering Mrs Henshall's daughters into the trial without having obtained her informed consent, in particular without having provided her with an information leaflet or informing her of the risks, benefit, efficacy and experimental nature of the treatment;

5) entering Stacey into the trial notwithstanding her ineligibility for it according to the trial criteria;

6) inadequate clinical care of Sofie;

7) knowing failure to follow the trial protocol;

8) employment of doctors and nursing staff unsuitably qualified and/or trained to develop or conduct the trial;

9) fraudulent misrepresentation of the results of the trial in order to further their personal financial interests in the development of CNEP equipment; and

10) conspiracy to misreport post-mortem results with a view to preventing any death being attributable to the trial.

Save for the first complaint of deception of the local ethics committee and the ninth of misrepresentation of the results of the trial, which were alleged against Professor Southall personally, the remaining summarised complaints insofar as they related to him, were, in the main, of a failure of supervision.

There was considerable delay on the part of the GMC in responding to Mr and Mrs Henshall's complaints. Instead of proceeding to investigate the complaint through its established machinery, it decided to await the publication of the Griffiths Report, commissioned by the NHS Executive in February 1999. The panel's terms of reference were "to look into the general framework for both the approval and monitoring of clinical research projects in North Staffordshire", that is, to examine the design of trials, including the CNEP trial, as distinct from clinical issues arising from them. In relation to the CNEP trial, the main conclusion in the Griffiths Report, which was published on 8^th May 2000 (some ten years after the local ethics committee had approved it) was that its design did not match what would, at the time of publication, be considered best practice. Professor Griffiths also made it clear in the Report that the panel had not sought to determine the truth of allegations of poor practice, or to apportion blame if practice could have been better, or to determine whether any actions taken at the end of the trial were wrong.

The main findings and recommendations of the Griffiths Report included the following:

(a) research governance, including practice and policies in individual trials, as well as in the North Staffordshire Trust generally, in the relevant period did not match what would, in 2000, be considered best practice;

(b) although the use of CNEP had been in routine use in the North Staffordshire Trust as a technique for respiratory support for children with bronchiolitis, the panel had not been able to identify a substantial evidential base to support it.

(c) some parents had alleged serious side effects from CNEP and, in two cases, the panel had heard claims that children had suffered serious brain damage or had died. The Trust, after examination of those claims, believed that the children had some signs of brain damage before undergoing the treatment.

(d) It was impossible for the panel to tell after such passage of time whether CNEP was the cause or made it worse, but it recommended that there should be "a substantial audit" of the Hospital "to see if claims of significant benefit or damage … [could] be substantiated".

Although Mrs Henshall placed much reliance on the Griffiths Report in her application before Pitchford J, it had only been indirectly before the PPC as the subject of considerable criticism in the Hey & Chalmers Article published in the BMJ in September 2000, a well documented and peer reviewed analysis. The Article contained a review of the Griffiths Report with the benefit of contemporaneous material that had not been before the Griffiths Panel and also information provided by the three doctors, in particular Professor Southall in his written response to the Griffiths Report. The first paragraph of the summary at the front of the Article gives the flavour of its authors' conclusions over-all:

"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."

In addition to a detailed criticism of the conclusions in the Griffiths Report, in particular as to the lack of foundation for many of them, and a reminder of the Griffiths panel's disclaimer of having sought to determine whether allegations of poor practice were true, Hey and Chalmers expressed the following view about the CNEP trial:

"… one can still form a view as to whether the research in question was properly conducted. The [Griffiths] panel seem to have concluded that it was not. We do not agree.

"… the conduct of the CNEP trial was exemplary. It was certainly up to the standard of most neonatal trials that were recruiting patients in Britain in the early 1990s;"

and

"… we found clear documentary evidence that the staff in Stoke went to unusual lengths to ensure that families were as informed as possible about the nature of the care on offer, both before and after entry to the study. The role of the nursing staff in this regard was particularly praiseworthy."

In a letter written by Dr Hey to Mr and Mrs Henshall of 26^th September 2000, in response to a letter from them about the Hey & Chalmers Article, he wrote:

"… 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."

In the same edition of the BMJ as that in which the Hey & Chalmers Article was published, there appeared a reply by Professor Griffiths, which, also was not directly before the PPC. In it, he wrote that the most important conclusion in his panel's report was of the need for a new research governance framework. He also referred to having received submissions from several expert witnesses of eminence that the North Staffordshire CNEP was probably no different from that in many other trusts at the time, namely in the early 1990s. He added that any criticism, real or imagined, in the Griffiths Report had nothing to do with the instigation of Mrs Henshall's complaints to the GMC, which had preceded the publication of the Report.

The Hospital then commissioned a confidential review by Professor Sir David Hull, assisted by a small team, to "inform its employment procedures". In effect this exercise became an enquiry into twelve research programmes conducted by Professor Southall, including the CNEP trial, during his time at the North Staffordshire Trust, to determine whether any disciplinary action should be taken against him. Among the material at which Professor Hull looked, was a North Staffordshire consent audit and a Midland Health Consultancy Network Report, both of which were favourable to Professor Southall and, indirectly, to Drs Samuel and Spencer. In December 2000 Professor Hull produced a report ("the Hull Report"), which, while expressing some concerns, was generally supportive of Professor Southall's and his colleagues' work. As a result, Professor Southall, who had been suspended as a result of Mr and Mrs Henshall's complaints to the GMC, was reinstated. (Given the confidentiality that the Hospital attributed to the Hull Report, Mrs Henshall did not see it until it was disclosed in these judicial review proceedings.)

Meanwhile, the GMC had yet to consider Mr and Mrs Henshall's complaints.

As I have said, under the 1983 Act and the 1988 Rules then governing the GMC's disciplinary procedures, there was a three tier system, an initial check largely as to formalities by a "screener", a second somewhat more rigorous check by the PPC as to whether they ought to refer a complaint for inquiry and determination by the PCC, and finally, if the PPC referred the matter to the PCC, the PCC's determination whether the complaint of serious professional misconduct was established.

In this case, the screener decided initially not to refer Mr and Mrs Henshall's complaints to the PPC. Following a threat by Mrs Henshall of a claim for judicial review arising out of his failure to take account of a large quantity of documentation that she and her husband had provided to the GMC, he decided in September 2002 to reconsider the complaints. In the course of his reconsideration he invited and received further written responses from the three doctors. In January 2004 he referred the complaints to the PPC.

All three doctors responded to the complaints, Drs Samuels and Spencer had first responded to the complaints in May 2001. Professor Southall had responded by letters from his solicitors in January and June 2002. But, unlike Drs Samuels and Spencer, he had done so, on condition that his responses would not be disclosed to Mr and Mrs Henshall. He provided a further response in February 2004 on the same condition. His reason, as set out in his solicitors' letters, was that he believed that Mr and Mrs Henshall would use the content of his responses to further a long-standing campaign against him by an action group, some of whom were associated with the Henshalls, opposed to his involvement in child protection work. He was specifically concerned that, in breach of an injunction, Mr and Mrs Henshall had sent to the GMC papers that had been stolen from his office. He maintained his refusal of consent to disclosure despite their offer to undertake not to use any information derived from his responses save for the purpose of their complaints to the GMC; he maintained that, because of their behaviour, he had no confidence that they would comply with any such undertaking. It looks from the way in which the GMC has pleaded its case in paragraph 10(4) of its summary grounds for resisting the application for permission to claim judicial review (see paragraph 54 below), that the screener felt bound to comply with his refusal.

The PPC considered the complaints and the doctors' responses to them and representations made on their behalf, the Hey & Chalmers Article, the Hull Report, and many other documents - over 3,600 pages in all. The PPC also refused disclosure to Mr and Mrs Henshall of Professor Southall's responses because of his refusal of consent to their disclosure. Having considered all that material, the PPC concluded that none of the complaints should be put before the PCC. The PPC's view in all three cases was that there was "no real prospect" of their proving the factual basis of their complaints and that even where there might have been, there was "no real prospect" of them proving that any of it amounted to "serious professional misconduct".

Mrs Henshall then applied for permission to claim judicial review in respect of the PPC's decision not to refer her and her husband's complaints against all three doctors to the PCC. She relied upon three main grounds, which I set out in a different order from that given to them in argument at the hearing and by the Judge in his judgment:

i) that the PPC, in their "filtering" role to determine whether to refer the complaints to the PCC, had acted irrationally or otherwise unlawfully in adopting too rigorous a test in considering whether her allegations of serious professional misconduct had "a real prospect of success", when they should have considered whether there was "a real as opposed to fanciful prospect of success";

ii) that the PPC's conduct of their filtering role was unfair to her and her husband in not disclosing to them Professor Southall's response to their complaints; and

iii) that the PPC had uncritically accepted the views in the Hey and Chalmers Article in support of the CNEP trial and without considering or considering adequately the Griffiths Report.

As I have said, Pitchford J refused Mrs Henshall's application. He did so because he was of the view that: i) the PPC, in considering whether the complaints had a "real prospect of success", applied the correct test; ii) the statutory scheme did not require disclosure of Professor Southall's responses at the PPC stage and that they had properly exercised their discretion not to disclose them in the light of his refusal of consent to such disclosure; and iii) the PPC were entitled to have regard to the criticisms in the Hey and Chalmers Article of the Griffiths Report as part of the material tending to undermine the complaints.

The statutory scheme

Before I consider each of the three issues, the Judge's rulings on them and the challenges to those rulings, I should say a little more about the statutory scheme then provided by the 1983 Act for the GMC's investigation and consideration of complaints of serious professional misconduct.^[1] By section 1(3) of the Act, the GMC was required to have a number of committees, including the PPC and the PCC and a Health Committee. By section 36 of the Act, the PCC could cause a medical practitioner's name to be removed from the register if found guilty of a criminal offence or guilty of serious professional misconduct. But, by section 42 of the Act, all complaints had first to be referred to the PPC for their decision whether such matter "ought to be referred for inquiry" by the PCC or the Health Committee.

By section 43 and paragraph 5 of schedule 4 to the 1983 Act, the GMC could make rules for the PPC as to how they were to discharge their function. At the material time, as I have said, the operative rules were the 1988 Rules, and they provided for a three tier system for consideration and determination of complaints. The first, the screener, was bound to refer the matter to the PPC after satisfaction of certain formalities unless it appeared to him "that the matter need not proceed further". Then there was the PPC whose role was to consider whether to refer the matter to the PCC, and to do so where it "appear[ed] to raise a question whether the practitioner ha[d] committed serious professional misconduct" or, as the courts, taking their lead from Lightman J's judgment in R v GMC, ex p Toth [2000] 1 WLR 2209, at para 14(5) (see paragraph 49 below), have interpreted that test, whether there was a "real prospect" of establishing such misconduct. And, finally there was the PCC whose role was to determine whether such conduct was established.

The initial consideration of cases by a "screener", for which Rule 6 provided, was clearly of a fairly basic or "narrow" kind, as Lightman J described it in Toth, at para 14(4), in which the issue was the extent of the screener's role. But, as was apparent from the requirement in Rule 6(3) to inform the practitioner of matters in the complaint "which appear[ed] to him to raise a question whether the practitioner ha[d] committed serious professional misconduct", he was expected to give at least some cursory consideration to that question. How far the screener had to go to be satisfied that the complaint "appear[ed] to raise" such a question may have some bearing on the PPC's determination of the same question, which was presumably intended to be more rigorous. This is how Lightman J attempted to contrast the two roles in Toth, at para 14(4):

"The role of the screener is a narrow one. It is to filter out from formally correct complaints, not those which in his view ought not to proceed further, but those which he is satisfied (for some sufficient and substantial reason) need not proceed further. For this purpose he must be satisfied of a negative, namely that the normal course of the complaint proceeding to the PPC need not be followed. … The absence of 'need', of which the screener must be satisfied before he can halt the normal course of the complaint to the PCC, connotes the absence of any practical reason for the complaint so proceeding and that for the complaint to proceed to the PCC would serve no useful purpose. There may be no need because there is nothing which amounts to a complaint; because the formal verification is lacking; because the matters complained of (even if established) cannot amount to serious professional misconduct; because the complainant withdraws the complaint; or because the practitioner has already ceased to be registered. Wider questions, as to the prospects of success of the complaint, as to whether the complainant is acting oppressively or as to the justice of the investigation proceeding further do not lie within the screener's remit. So far as they may go to the issue whether complaint ought to proceed, they fall within the remit of the PPC. It is not for the screener to arrogate to himself the role of the PPC and decide whether the complaint ought to proceed further, still less to arrogate to himself the role of the PPC and weigh up conflicting evidence or judge the prospects of success. He must respect the role assigned by the Rules to the PPC (for which the PPC is armed with investigative powers) and recognise that his duty is only to act as preliminary filter before the more substantive role as filter is exercised by the PPC." (my italics)

The more substantial "filtering" role of the PPC was governed by Section 42(2) of the 1983 Act, which required them to consider any case referred to them by the screener and to determine whether it "ought to be referred" to the PCC for an inquiry. Given the judicial gloss placed by Lightman J in Toth on the test indicated by Rule 11(2) of the 1983 Rules for making that decision, I should set out the material part of the Rule:

"When referring a case to the Professional Conduct Committee the Preliminary Proceedings Committee shall indicate the convictions, or the matters which in their opinion appear to raise a question whether the practitioner has committed serious professional misconduct …" [my italics]

As I have indicated, Lightman J's gloss in Toth, which was in paragraph 14(5) of his judgment, was that the PPC's task was to determine whether there was a "real prospect" of the complaint being established before the PCC.

In the light of that judgment, the GMC provided guidance to PCC members in the form of an aide memoire prepared for them by counsel ("the Aide Memoire"). It was expressly approved by Burton J in Woods v GMC [2002] EWHC 1484 Admin, at para 14(ii), and included the following:

"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."

Lightman J's and the GMC's test of a "real prospect" of establishment of a complaint has been approved and applied in a series of recent High Court judgments, namely: R (Richards) v GMC [2001] Lloyds Med Rep 47, per Sullivan J at para 58, subject to two qualifications not affecting the fundamental nature of the tests (see paragraph 49 below); R v GMC, ex p McNicholas [2001] EWHC 279 Admin, per Sullivan J at para 12; and, as I have noted, R (Woods) v GMC, per Burton J at para 14(ii). It was also seemingly approved by Jonathan Parker LJ, with whom Laws and Keene LJJ agreed, in R (Holmes) v GMC [2002] All ER (D) 412, CA, at para 74.

Where the PPC decide not to refer a complaint to the PCC, Rule 11(5) required them to inform the complainant and the practitioner of their decision "in such terms as the Committee direct[ed]". Rule 13(1) empowered the PPC, before making their decision, to cause further investigations to be made and/or to seek legal advice and assistance. Rule 13(2) enabled them where, inter alia, they considered that further investigations were desirable, provisionally to refer the matter to the PCC. And Rule 16 provided, as Rule 10(4)(a) provided for the screening stage, that where the PPC decided not to refer a complaint to the PCC the complainant should not have a right of access to documents submitted to the GMC.

It is only at the PCC stage that the matter assumed the character of the traditional forensic process, with sequential mutual disclosure of documents, a public hearing which began by the reading and putting of the "charges" to the accused, a hearing in which the GMC and the accused doctors could be represented by lawyers, where evidence was prepared and given in traditional form, orally and/or in writing, and where the evidence of witnesses on each side could be tested in cross-examination.

Issue 1 -The PPC's "Filtering" Role

As I have indicated, Pitchford J rejected the submission of Mr Ian Wise on Mrs Henshall's behalf that the PPC had acted irrationally or otherwise unlawfully in deciding not to refer the matter to the PCC. That submission had two parts to it. The first was that the PPC's threshold for referral, namely "a real prospect of success" was too high and that, in applying that test, they should have added to it so that it read "a realistic prospect as opposed to a fanciful prospect of success". The second was that, whatever the precise formulation of the test, the PPC had usurped the role of the PCC by resolving issues of fact.

It is instructive to consider the PPC's decision letter of 12^th March 2004 to see how they approached their task and whether there is any life in the same complaint that Mr Philip Havers QC makes on Mrs Henshall's behalf before this Court. I can deal with this relatively briefly, as the Judge, with the same exercise in mind, has set out, in paragraphs 43 to 45 of his judgment, extensive passages from their reasoning in the case of each practitioner.

First, the PPC, not only consistently stated and applied the Toth test of a "real prospect" of establishing the complaints against the doctors before the PPC, they also made specific reference to the Aide Memoire by way of preface to their individual treatment of the complaints against each doctor.

Secondly, in the case of all three doctors, the PPC reached their decision after setting out the complaints and the issues on them raised in their responses, the Hey & Chalmers Article and Professor Griffiths' response to it, the Hull Report and the other documentation. The following summary in their decision letter of their conclusion in relation to the complaints against Professor Southall, though focusing in his case on his responsibility for design and oversight, is typical of their approach to all three:

"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 Judge considered that those conclusions were not the product of a misunderstanding by the PPC of their role, but a proper outcome of a detailed examination of the material before them on which they were entitled to conclude that there was no real prospect of Mr and Mrs Henshall establishing serious professional misconduct before the PCC. In reaching that conclusion, he likened the general issue before the PPC to a prosecution in which the case for the prosecution consisted of Mr and Mrs Henshall's affidavits setting out their complaints, "purportedly supported" by the Griffiths Report, and:

"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."

The Judge's reaction, at paragraph 69 of his judgment, to Mr Wise's addition to Lightman J's test of "real prospect of success", namely that it should be "a realistic prospect of success as opposed to a fanciful prospect of success", was that it seemed to him to be precisely the test described in the Aide Memoire, in particular the final sentence of paragraph 2 of it (see paragraph 30 above). He said:

"… 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."

Accordingly, he concluded in paragraph 70 of his judgment that Mr Wise had nothing to complain about in this respect:

"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. …"

As to the second part of Mr Wise's contention that the PPC acted irrationally or otherwise unlawfully in its decision not to refer in that it usurped the fact-finding role of the PCC, the Judge identified what he saw as the PPC's task and distinguished it from that of the PCC. He commented on the nature and volume of the "evidence" that had been put before the PPC and described its task and how it went about it thus:

"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 of 12^th March 2004. …"

Submissions

Mr Havers, on behalf of Mrs Henshall, returned to the first part of Mr Wise's submission on this issue to the Judge, that the PPC, in failing to consider the obverse of a real prospect of success, namely a fanciful prospect of success, had adopted the wrong or an incomplete test. He acknowledged that the PPC, in their decision letter, had expressly prefaced their treatment of the complaints against each doctor with a reference to the Aide Memoire, which juxtaposed to and contrasted with the "real prospect" test the expression "not [a] a remote or fanciful" possibility. But, he complained, they should have spelt out the exact terms of that expression when dealing with each doctor. He suggested that the Judge was wrong to dismiss it as a semantic point in the circumstances, because the PPC, whilst referring in their decision letter to the "real prospect" test, did not indicate their understanding that a complaint, to have a "real prospect of success", merely has to be not "fanciful". He argued that a "real not fanciful prospect" test is a significantly lower than the unqualified "real prospect" of success test applied by the PPC.

Mr Havers prayed in aid in support of his submission, as Mr Wise had done before the Judge, the criticism of Dame Janet Smith in her Report on the Shipman Inquiry, of the general approach of the PPC as too focused on the interests of doctors in contrast with the interests of patients. He suggested that the PPC's failure in this case expressly to balance the "real prospect" test against a fanciful prospect of success showed that they were, on the material before them, too focused on the interests of the doctors in this case, leading them to adopt the wrong test for referral to the PCC.

Faced with the responses of counsel for the GMC and the doctors that the Judge had rightly dismissed this approach as semantic, Mr Havers turned to what he submitted was a lower test than Lightman J's gloss of "a real prospect of success" to the threshold for referral as set out in Rule 11(2), namely whether the material before the PPC "appear[ed] to raise a question" of serious professional misconduct.

Mr Shaw and Mr Kennedy submitted that the PPC and the Judge, in applying the "real prospect" success test, applied the correct test, namely that as precisely identified by Lightman J in ex p Toth and followed and approved in the authorities to which I have referred briefly in paragraph 31 above. To contrast that with a fanciful prospect of success, they submitted, neither added anything to the test nor was necessary as a matter of emphasis.

Miss Mary O'Rourke, on behalf of Drs Spencer and Samuels, on the other hand, urged the Court to disregard Lightman J's gloss on the statutory scheme and its adoption and elaboration by the PPC in the Aide Memoire, since neither bound this Court. She characterised the seeming acceptance of it by Jonathan Parker LJ in Holmes, at para 74, as only a passing reference. She submitted that the PPC should have adopted the test for prosecutors in paragraph 5.1 of the Code for Crown Prosecutors, namely whether there was "a realistic prospect of conviction", taking account of criminal rules of evidence and the criminal burden and standard of proof, that is whether the PCC was more likely than not to find that serious professional misconduct had been established. However, she concluded that whether the test was expressed as a matter of possibility, as suggested by the formula in Rule 11(2), or as a balance of probability, to which the Toth test inclines, is immaterial in the circumstances of this case because the PPC rightly found that the complaints reach neither threshold.

Conclusion

I am not sure whether there is very much between the various formulations of the test for the PPC that have been discussed in this appeal. First, and most obviously, I agree with the Judge that, other than as a matter of emphasis, the words "not a fanciful prospect" of success add nothing to Lightman J's gloss of "a real prospect" of success on the statutory test. As Mr Shaw observed, by reference to an observation of Lord Woolf MR (as he then was) in Swain v Hillman [2001] 1 All E R, 91, CA, at 92j, it is self-evident, even if not spelt out, that a fanciful prospect of establishing a case is not a real prospect of doing so.

Secondly, although the test as stated in Rule 11(2), whether the complaint "appear[ed] to raise a question" could be said to be lower threshold than "a real prospect of success" and more of a piece with the PPC's characterisation of it in paragraph 2 of the Aide Memoire as a "genuine … possibility" rather than a probability, I doubt if there was much between the Rule 11(2) formulation and Lightman J's gloss on it as a matter of practical application. It is true, as Sedley LJ observed in argument with reference to Rule 11(2), that the PPC could only refer a matter to the PCC if "in their opinion it appear[ed] to raise a question whether the practitioner ha[d] committed serious professional misconduct", but that it was not for the PPC to answer that question. But to my mind, for the PPC to conclude that a complaint had a real prospect of success, as distinct from a probability or a real probability of success, was just another way of saying that it appeared to them to raise a question that ought to be referred to the PCC for determination. Similarly, I do not consider that the test, "a realistic prospect of conviction" in the Code for Crown Prosecutors, as espoused by Miss O'Rourke is a materially different test, taking into account, the criminal standard of proof for the realisation of such prospect before the PCC and the need to proceed with caution as paragraphs 2 and 3(4) of the PPC Aide Memoire advised. It is interesting in this context to note how Jonathan Parker LJ in his seeming acceptance in Holmes, at para 74, of the "real prospect of success" test in Toth and Richards, equated it with "an arguable case" of serious professional misconduct.

It is clear from the PPC's decision letter that, in the case of each of the three doctors, they applied the "real prospect" of success test. And, for what it was worth, they did so, having in mind the contrast drawn in paragraph 2 of their Aide Memoire of a remote or fanciful prospect, and they did so both as to the establishment of any relevant facts in support of each complaint and to the question whether such facts, if established, could amount to serious professional misconduct. Accordingly, in my view, the Judge correctly held that the PPC had applied the correct test and that, even on Mrs Henshall's case before him as to its meaning, she had nothing to complain about. As to the general criticism made by Dame Janet and the possible need for reformulation of the test for referral by the PPC, the Judge rightly observed that whether or not there was a need for such reformulation, it was not his task; he was there to apply the law as it was, not as it might become.

As to the more focused way in which Mr Havers put it to this Court, perhaps a re-framing of a further submission that Mr Wise made to the Judge, namely that the PPC usurped the role of the PCC by resolving issues of fact, it is necessary to keep in mind the different functions and procedures of the PPC and PCC. Whilst the former was to act as a "filter" for the latter before referring to it complaints of serious professional misconduct, and the latter was to decide on evidence put before it whether such complaints were established, the filtering was clearly intended to take a more rigorous form than that conducted by the screener, though not so rigorous as the determinative and forensic role of the PCC. In particular, it was not adjudicative in the sense of considering oral and written evidence and its adequacy, presented in the event of referral for the first time to the PCC and tested in its inquiry by a forensic process and after full mutual disclosure. The latter was the sole function of the PCC as Lightman J's comparative analysis in Toth, at para 14(5) and paragraphs 3 (1), (2) and (3) of the Aide Memoire make plain, the former reading:

"… The PPC's role is to decide whether the complaint ought to proceed. This language must be read in the context of a scheme under which the complainant has no right to the practitioner's comments on the complaint or other material put before the PPC, and a scheme in which the central feature is the investigation of complaints by the PCC before whom alone there is full disclosure of documents and evidence and a form of hearing where the complainant (and public) can see, and be reassured by seeing, the proper examination of the merits of the complaint. The PPC may examine whether the complaint has any real prospect of being established, and may themselves conduct an investigation into its prospects, and may refuse to refer if satisfied that the real prospect is not present, but they must do so with the utmost caution bearing in mind the one-sided nature of their procedures under the Rules, which provide that that, whilst the practitioner is afforded access to the complaint and able to respond to it, the complainant has no right of access to or to make an informed reply to that response, and the limited material likely to be available before the PPC compared to that available before the PCC. It is not their role to resolve conflicts of evidence. … the PPC must bear in mind their limited (filtering) role and must balance regard for the interests of the practitioner against the interests of the complainant and the public and bear in mind the need for the reassurance of the complainant and the public that complaints are fully and properly investigated and that there is no cover-up. In the case of the PPC … any doubt should be resolved in favour of the investigation proceeding." (my emphasis)

However, although the respective roles of the PPC and PCC may be contrasted in the manner indicated, there remains a question of how light a touch the PPC should exercise in determining whether to refer a complaint to the PCC. The Judge clearly had this problem much in mind in paragraphs 73, 76 and 77 of his judgment (see paragraph 40 above), as did Sullivan J in Richards, at paragraph 58, where he endorsed Lightman J's analysis, subject to two matters of what he described as "emphasis". The first was to question the need for utmost caution in every case before deciding not to refer, particularly given the Rule 11(2) test whether the matters "appear to raise a question" whether the practitioner has committed serious professional misconduct, and in circumstances where the complaint stems from a finding of another medical body. The second was as to Lightman J's general proposition that it was not the PPC's role "to resolve conflicts of evidence", which Sullivan J qualified:

"I would prefer to say that it should not normally seek to resolve substantial conflicts of evidence. To do so would be to go beyond its screening role and to usurp the function of the PCC. Although section 42 of the Act appears to confer a very broad discretion upon the PPC, its proper role is as described by Lightman J. …" (my italics)

It is plain that it was not the job of the PPC to conduct an inquiry in the full or evidential sense. Its role was not to consider "evidence"; that was for the PCC's consideration if the matter reached it, evidence that could be forensically tested and with the benefit of mutual disclosure. The PPC's role was to consider whether material put before it on paper raised a question as to serious professional misconduct that "ought to be" the subject for evidential presentation to an inquiry by the PCC. If there was to be a gloss on the statutory test, it seems to me that the expression "whether there is cogent indication of a question to be answered" comes closer, as a matter of contextual interpretation and of public policy, to identifying the PPC's role than that of a "real prospect of success". It cannot have been sufficient simply to raise a question for this purpose for there to be some conflict or indication of conflict in the respective accounts put before the PCC, regardless of the materiality of the conflict or of the relative cogency and weight of the material on one side and the absence or paucity of it on the other. Following Sullivan J's train of thought in his second qualification to Lightman J's formulation of the PCC's role, if there was no material and cogent information before the PPC to set against overwhelming information in favour of the doctors' responses to Mr and Mrs Henshall's complaints, it was plainly open to them, if they were to act as an effective filter, to make a value-judgment to that effect and decide, on that account, not to refer.

Whatever shade of the test was appropriate, I agree with Miss O'Rourke's submission, and with the Judge's reasoning that the material before the PPC fell short of the threshold for reference to the PCC. On the one side, apart from the Henshalls' representations, the only expert material of substance was the Griffiths Report which was concerned with how such trials should be devised and conducted some ten years after the events in question. On the other, there were the peer-reviewed and far better documented Hey & Chalmers Article highly critical of the Griffiths Report so far as it went, Professor Griffiths' own response to the Article, disclaiming any criticism of the doctors' design and conduct of the trial according to the standards at the time when it was undertaken, and the Hull Report, including its references to two other investigations, all generally supportive of the doctors' conduct of the trial. In the circumstances, it was plainly, and as a matter of common-sense, open to the PPC to identify and give effect to the significant disparity in relevance, cogency or weight of the material relied upon respectively by Mr and Mrs Henshall in support of their complaints and that relied upon by the doctors. This was how the Judge saw it, correctly so, in my view, in paragraphs 72, 74 and 75 of his judgment:

"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."

Accordingly, I reject the complaints constituting the first ground of appeal that the PPC applied the wrong test in law or misapplied the correct test on the material before them.

Issue 2 - Disclosure

This issue relates only to the complaints against Professor Southall. It is whether the PPC's decision not to disclose to Mr and Mrs Henshall his three responses to their complaints breached common law rules of fairness. The starting point for discussion is rule 16 of the 1988 Rules, to the substance of which I have already referred and which, verbatim, provided:

"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."

It should be noted that, as to a complainant's entitlement to disclosure, the application of the Rule fell only for consideration by the PPC at the end of their deliberations and when they had decided not to refer the matter to the PCC.

The PPC, like the screener, appear to have declined to disclose Professor Southall's responses to Mrs Henshall because they considered his refusal of consent to be an absolute bar to disclosure, the first of two alternative arguments relied upon by Mr Shaw on behalf of the GMC before the Judge and this Court. As I have said, that appears from paragraph 10(4) of the GMC's summary grounds for resisting the application for permission to claim judicial review:

"(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."

Pitchford J rejected Mrs Henshall's challenge to the PPC's decision on this issue on two related grounds, first, that the statutory scheme, in particular Rule 16, did not require such disclosure and, secondly, because he considered that the PPC had properly exercised the discretion they had to refuse it. Unlike the PPC, he did not act on Mr Shaw's primary argument on the second ground that a doctor's refusal of consent, for whatever reason, operated as an absolute bar to disclosure.

As the Judge noted, this aspect of the statutory scheme was considered by Lightman J in his judgment in Toth, at paras 15 and 16, in which he held that, though the Rules did not entitle a complainant to see material made available to the screener or to the PPC, they gave them discretion in the matter. Lightman J also referred to the adoption by the GMC of a "new practice" from 1^st July 2000 under which, in the absence of "exceptional circumstances", the screener should copy to the complainant the doctor's responses to the complaint. That practice expressly recognised as an exceptional circumstance for this purpose, one where disclosure could cause substantial harm to the doctor and/or to a third party, for example by the disclosure of confidential medical material. In such a circumstance, the practice expressly acknowledged that the screener might exercise his discretion to allow it against an undertaking from the complainant as to confidentiality and/or to allow partial or edited disclosure.

Lightman J, having considered that development at screener level, concluded, at paragraph 16 of his judgment:

"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. …"

We are told that this had always been the practice in respect of sought disclosure against the PPC. It is illustrated in the following passage from a letter of 19^th September 2002 from the GMC in its letter of 19^th September 2002 to the solicitors for Drs Spencer and Samuels:

"… 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."

Pitchford J, at paragraph 57 of his judgment, acknowledged that approach as a permissible exercise of discretion in the application of rule 16 and adopted Lightman J's analysis for the purpose, saying:

"… 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."

The Judge then referred to Professor Southall's representations through his solicitor and to affidavits submitted on his behalf that he had been concerned that any disclosure of such documents might be used to harass or damage him. The Judge's approach was to consider whether Professor Southall had proper grounds to fear that such disclosure would be used for that purpose, not whether in fact they would be so used, and whether, even so, to withhold disclosure would be unfair to Mr and Mrs Henshall. In the following paragraphs of his judgment, he found that Professor Southall had good grounds to fear harm from the sought disclosure, that to withhold it would not be unfair to them and, notwithstanding the GMC's pleaded case, that the PPC had achieved that by exercising a discretion in the matter:

"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. "

Submissions and Conclusions

Mr Havers submitted, as Mr Wise had submitted to the Judge, that, regardless of judicial scope for discretion, the bar on a complainant's entitlement to disclosure provided by Rule 16, operated only after a decision by the PPC not to refer the matter to the PCC, not during the course of its consideration whether or not to refer. That rule 16 should be read in this way is clear, he submitted, from its wording and because of its location at the end of the Part, Part III of the Rules dealing with the PPC's procedure. On the premise that the statutory scheme is silent as to a complainant's right to disclosure before the PPC reached a decision one way or the other, he had recourse to Lord Denning MR's solution in R v Secretary of State for the Environment ex parte Norwich City Council [1982] QB 808, at 842G, that the common law should fill the lacuna, and to Sedley LJ's articulation in R v Camden LBC ex p Paddock CO/2817/92 at page 16 of the principle adumbrated a long time before by Lord Loreburn LC in Board of Education v Rice [1911] AC 179, at 182:

"… that a decision-making body should not see relevant material without giving those affected a chance to comment on it and, if they wish, to controvert it, is fundamental to the principle of law (which governs public administration as much as it does adjudication) that to act in good faith and listen fairly to both sides is 'a duty lying upon everyone who decides anything'" …

Mr Havers, whilst acknowledging that the requirements of fairness differ according to context, contended that the nature of the present case was such that fairness demanded disclosure of the responses of Professor Southall to Mr and Mrs Henshall's complaints. He submitted that the Judge wrongly distinguished the present case from Paddock on the basis that Paddock concerned a final determination, whereas decisions of the PPC do not.

However, as Mr Shaw and Mr Kennedy observed, it follows as a matter of inexorable logic from the express prohibition in Rule 16 of disclosure where there had been a decision not to refer, that it precluded a right, as such, to disclosure before such decision. Otherwise, the prohibition would have been nugatory. If any further justification were required for that interpretation of Rule 16, it was no doubt to be found in the draftsman's conception of the PPC's role in the statutory scheme as a preliminary and limited form of paper inquiry in the disciplinary process, in contrast with the forensic procedures of the PCC in which mutual disclosure could, for the first time, be directed, and "evidence", both oral and written, presented and tested. Moreover, the draftsman had provided, through Rule 13(1) a means of enabling the PPC to satisfy the demands of fairness by way of further investigations and/or seeking legal advice or assistance. In this case, for instance, they could have exercised that statutory power, if they had considered it necessary or desirable to explore any points raised by Professor Southall not covered in the complaint or with which they considered the complainant should have had an opportunity to deal.

As to the finality or otherwise of the PPC's decisions, I agree with Mr Havers that, although their decisions to refer were not final in that they were preliminary to determinations of the PCC, for Mr and Mrs Henshall the PPC's decision not to refer was, subject to challenge by way of judicial review, "the end of the road". It was a decision that concluded this matter and prevented a full inquiry. Moreover, given the discretionary overlay to which I have referred, it is via that route – the one already taken by the GMC in the adoption of its "new practice" (see paragraph 57 above) – not the misreading of Rule 16, by which GMC and the courts should have recourse to the common law and Lord Loreburn's fundamental principle of fairness.

Turning to that discretionary alternative, Mr Havers submitted that the PPC had a discretion voluntarily to disclose and, where fairness demanded it, to exercise it even if that necessitated overriding a doctor's refusal of consent. Mr Shaw, Mr Kennedy and Miss O'Rourke acknowledged that the Rules did not preclude voluntary disclosure by the PPC of a doctor's response to a complaint. But, they maintained, the PPC could only do so if the doctor consented; if he refused, they had no discretion to override his refusal whatever his reason for it. The rationale for such a rule, Mr Kennedy maintained was that, in the context of disciplinary proceedings against a doctor, the latter should be free to put his version of events without fear of attracting further denunciation. Alternatively, they argued, relying by analogy upon Lightman J's reasoning in Toth, at para 16, in relation to material before a screener (see paragraph 58 above), if he refused consent on what they considered to be reasonable grounds, they had a discretion whether to refuse disclosure in the interests of fairness or to grant it against an undertaking of confidentiality from the complainant upon which he could rely. Mr Shaw and Mr Kennedy submitted that, here, the PPC refused to disclose on proper grounds, namely that Professor Southall had reasonably refused consent because he had cause to believe that an undertaking of confidentiality would or could be valueless.

However, if, as is plain, Rule 16 left room for a discretion in the PPC whether to disclose doctors' responses to complainants, it could only have been a discretion exercisable in the interests of fairness as between both parties. The fact, for example, that a doctor might have had a good or reasonable explanation for refusing consent did not on that account alone necessarily make it fair to withhold his response.

Accordingly, I agree with Mr Havers' submission that there is no legal basis upon which a doctor in a response to disciplinary proceedings before the GMC had any right to refuse consent to disclosure to the complainant, on the ground of confidentiality or otherwise, so as effectively to remove from the PPC a discretion whether or not to make disclosure in the interest of fairness of both parties. If and to the extent that Lightman J contemplated such a possibility in paragraph 16 of his judgment in Toth, I respectfully disagree. However, it looks from his discussion of ways around the problem to enable the GMC "voluntarily in accordance with the principles of fairness [to] decide. In principle that disclosure should be made", that he did not regard the doctor as having the final word.

Here, the issue was not so much a matter of professional or personal confidentiality, but of concern on the part of Professor Southall that what he regarded as his sound answers to the complaints might be misused by Mr and Mrs Henshall or by others for other purposes. Such a concern was relevant to the PPC in determining whether fairness to both parties demanded disclosure and, if so, on what terms. It is plain that the PPC exercised their discretion in taking the first step towards finding a fair solution, namely by seeking and obtaining an offer of an undertaking from Mr and Mrs Henshall not to use any information derived from Professor Southall's responses other than for the purpose of the disciplinary proceedings.

The question is whether the PPC should have taken and did take the next step along that discretionary road of considering what fairness demanded in the light of Professor Southall's continued refusal to disclose because, in the light of his experience of their and others' conduct, he was concerned about their willingness and/or ability to honour such an undertaking. Whilst the PPC may have considered how far such concern went to justify his stance and, if so, whether, nevertheless, fairness as between the parties demanded disclosure, they appear to have been content, according to the GMC's pleaded case, to have taken a stand simply on basis of his refusal. For the reason I have given, I do not consider they were entitled to do that. As Sedley LJ observed in the course of counsel's submission, the GMC cannot hide behind a doctor's purported veto on disclosure of his responses under a general plea of confidentiality or otherwise.

In my view, in the circumstances of this case, the PPC would have been entitled to regard as reasonable Professor Southall's explanation for refusal of disclosure even against an undertaking from Mr and Mrs Henshall to keep it confidential, and as fair between the respective interests of the parties. But, as I have said, the PPC did not refuse disclosure on that basis. Contrary to the Judge's inferential findings in paragraphs 59 to 63 of his judgment (see paragraph 61 above), it is evident from the way in which the GMC had pleaded its justification for resisting disclosure (see paragraph 54 above), that the PPC exercised no discretion at all on this aspect of the matter; it had simply acted on Professor Southall's refusal.

As the Judge observed in paragraph 60 of his judgment, the issue was ultimately one of fairness and, notwithstanding the reasonableness or otherwise of Professor Southall's stance, there might have been something in his responses upon which, as a matter of fairness the Henshalls should have been given the opportunity to comment. But all the signs, as the Judge indicated in his further reasoning in the paragraph, were against it. There was nothing in the PPC's decision letter turning on the truthfulness or accuracy or otherwise of Professor Southall's responses upon which Mr and Mrs Henshall had not already dealt in their voluminous documentation and which was not also supported in important respects by other material before the PPC and made public in the Hey & Chalmers Article.

In my view, and contrary to Mr Havers' submissions on the matter, I consider that the Judge was entitled in the circumstances to express the view in paragraph 61 of his judgment that there was no reasonable prospect of Mr and Mrs Henshall having been deprived, by lack of access to Professor Southall's responses, of an adequate opportunity to demonstrate at that stage that they had a reasonable prospect, if there was one, of establishing their complaints of serious professional misconduct against him. In short, on the material before the Court, I am of the view that, even if Professor Southall's representations had been disclosed to Mr and Mrs Henshall, they would not, in the circumstances of this case have made any difference to a proper exercise by the PPC of its discretion, if they had exercised it to the full.

Accordingly, I would also reject this ground of appeal.

Issue 3 - Hey & Chalmers Article

I have effectively dealt with this ground of appeal, in paragraphs 50 - 52 of this judgment, when dealing with the first and main ground of appeal as to the PPC's test for referral. For the reasons given in those paragraphs, notably those of the Judge with whose reasoning in paragraphs 72, 74 and 75 of his judgment set out in paragraph 52, I there agreed, I am firmly of the view that the PPC were entitled to rely on the Hey & Chalmers Article and considerable supporting material in deciding, in the proper exercise of their referral function, not to refer Mr and Mrs Henshall's complaints to the PCC. In summary, and contrary to Mr Havers' submissions:

1) the Griffiths Report was effectively before the PPC and its implications if and insofar as they were relevant to Mr and Mrs Henshall's complaints must have been considered by the PPC, since it was the centre-piece of the criticisms in the Hey & Chalmers Article;

2) on the critical issue of the integrity of the design and of the conduct of the CNEP trial according to the standards of the day when it was conducted, there was no substantial conflict between the Griffiths Report and the authors of the Hey & Chalmers Article and the other material supporting the latter, as Professor Griffiths himself acknowledged in his reply to the Article; and

3) the effect of the Hey & Chalmers Article and supporting material, to the extent that it bore on any aspect of the Griffiths Report that might have been supportive of Mr and Mrs Henshall's complaints, seriously undermined it; the PPC could not have reasonably failed so to conclude, and, in my view, were entitled to do so as part of their referral role.

Accordingly, I would also reject this ground of appeal.

In consequence, I would dismiss the appeal. I add that, given the considerable lapse of time – 13 years - since the CNEP trial and the considerable body of medical exploration that it has engendered to little or no identifiable advantage to Mr and Mrs Henshall's complaints and to much unjustified professional disruption and personal distress of the doctors, I would, in any event, have been inclined to refuse relief in the exercise of my discretion. In saying that, I have not forgotten the tragedy that Mr and Mrs Henshall have undergone and from which they continue to suffer. All I say is that, I can see no way, certainly by this stage, in which they could establish a grievance in public law in respect of which the law could help them.

Lord Justice Sedley :

For the purposes of this judgment I adopt with gratitude the full account of the facts and issues contained in the judgment of Auld LJ. My conclusions, however, differ from his. In my judgment, while one cannot necessarily fault the test applied by the PPC, the way in which it applied the test was wrong and the materials to which it applied the test were so weighted against the complainants by unfair procedure as to vitiate its decision.

The correct legal test

There is only one legally correct version of the test which the PPC was required to apply in order to decide whether a matter, in the words of s.42, ought to be referred for inquiry by the PCC. It is the test to be found in the delphic language of rule 11(2): does the complaint appear to the PPC to raise a question whether the practitioner has committed serious professional misconduct? The test is self-evidently designed only to eliminate complaints which raise no question capable of resulting in a finding of serious professional misconduct. Such findings must, as Miss O'Rourke submits, be capable of being established beyond reasonable doubt if a complaint is to pass the test. But rule 11(2) does not permit the PPC itself to attempt to answer any question which is raised by a complaint: that is for the PCC if the complaint otherwise passes muster.

All the formulations which appear in the decided cases are paraphrases of the rule. But, as the submissions in this appeal have shown, every paraphrase brings further problems of meaning in its wake. Lightman J's careful and helpful exegesis in Toth - 'a realistic prospect' – invites the question whether a prospect which is more than fanciful can still be less than realistic. The question cannot be answered from the statute or the rules, which contain neither phrase, so that to devise an answer is to travel still further from the words of the rule.

But this is not to say that the aide-memoire (see paragraph 30 above) was legally wrong or misleading. The want of a clear test in either the Act or the Rules made explanations of this kind inevitable. In many cases, perhaps most, it will have made little or no difference which formula was used. If the present case turned upon it, it would be necessary to make a close analysis of the PPC's decision in order to decide whether it had impermissibly raised the threshold. But, for reasons to which I now turn, the dominant problem with its decision is not the relatively nice one of the standard to which the PPC evaluated the material before it. It is the much larger one of the material which was included in and excluded from its consideration, and of how far it went in reaching its decision.

The withholding of Professor Southall's response

Rule 16 (see paragraph 54 above) was a most peculiar rule. On its face it provided only for the non-disclosure of materials by the PPC following a decision to make no referral. Whatever its purpose (and none is readily apparent), one of its principal effects was to ensure that the author of a complaint which had been rejected without due process had no way of finding this out unless it appeared on the face of the decision letter. A second effect, germane to this case, was that the rule was ineffective unless the PPC also adopted a policy of non-disclosure prior to its decision on referral. Whoever drafted the rule appears to have been unaware that the common law has always refused to countenance any such policy unless it is unequivocally mandated by Parliament. Yet the overriding of this tenet of the common law was the necessary basis of Mr Shaw's submission that rule 16 by necessary implication forbade disclosure in the absence of consent.

Of course not every document which came to the PPC required disclosure. If that had been the case, every complaint would have risked becoming an endless war of words. But it was in my judgment completely unacceptable to derive by implication from rule 16 a general inhibition which, by enabling a practitioner to put in potentially contentious material in response and to deny sight of it to the complainant, was capable of stifling the individual's right to bring a tenable complaint to the attention of the Professional Conduct Committee of the GMC. Suppose, for example, that the practitioner were to respond to a complaint by making damaging personal assertions about the complainant which could be refuted but which the practitioner refused to allow to be disclosed. It could make the difference between referral and non-referral of a well-founded complaint.

Somehow, therefore, the PPC had to operate rule 16 fairly. In my view the only way to do so was to recognise that there were two competing imperatives: the fact that rule 16 would become ineffective to the extent (not necessarily a large one) that documents were disclosed by the PPC in the course of its work, and the fact that the PPC could not do its work fairly or therefore lawfully if significant material were able to be put in by practitioners and kept from the knowledge of complainants. The solution was to consider in each case what the practitioner had put in; to decide whether in fairness it was something the complainant should be able to respond to; and, if it was, to tell the practitioner that unless he or she agreed to the disclosure of the material it would be ignored by the PPC.

The speeches in the House of Lords in Roberts v Parole Board [2005] UKHL 45, which were published shortly after the hearing before us, while not immediately in point, contain reasoning which in my present view (for we have not considered it necessary to call for argument on it) supports the conclusion set out above. It is reasoning which might permit non-disclosure of a response which, for instance, placed the practitioner at risk of violence if it were to be disclosed; but the concerns expressed by Professor Southall about the Henshalls (who were not members of the action group and whose concerns differed from those of the group) were not in this league and were capable of being met by undertakings.

The PPC erred in law in failing to appreciate – no doubt because it had not been advised – that it should take the approach I have outlined to Professor Southall's submission. It has not been submitted to us (it could not logically be) that what Professor Southall wrote was inapt for disclosure. The natural inference is that it was material which, but for its supposed obligation of confidentiality, the PPC would or might well have sought the Henshalls' comments on. It follows either that the Henshalls have been denied the opportunity to respond or that the PPC has taken into account material which it should have ignored.

The Hey and Chalmers article

The PPC accepted and clearly gave considerable weight to the Hey and Chalmers article. In doing so it erred, in my view, in two related ways. First of all, it embarked upon the evaluation of evidence, a task not confided to it by law. Secondly, it did so upon manifestly partial material. The two issues are related because, if the evidence placed before it on a material question were to be substantially all one way, the PPC was undoubtedly entitled to rely on it in deciding whether the complaint had raised a question of serious professional misconduct; while if it were not, and if the conflict required resolution before the statutory question could be answered, it was the PCC who had to resolve it.

The Griffiths report was neither placed before nor obtained by the PPC. With the greatest respect, I am unable to agree with Auld LJ's formulation that it was effectively before them. What the PPC had was a swingeing attack on Griffiths by two authors, both of whom had correctly and candidly declared an interest of some significance: that their report had been bespoken (though not paid for) by the doctors' insurance body, the Medical Defence Union. All the PPC knew of Griffiths' findings was what Hey and Chalmers said about them. The fact that Griffiths, in a measured response, pointed out that his critique had been limited to a finding that the design and conduct of the CNEP trial did not meet the standards of the time, ten years on, of his report, did not amount to an acknowledgement of the justice of Hey and Chalmers' attack on him. And while the authors of the article, in a letter which was sent on by the Henshalls to the PPC, disclaimed any opinion as to whether the clinical trial (as opposed to the Griffiths inquiry) had been properly conducted, at least one of the decision letters shows that the PPC relied on their description of the conduct of the trial as 'exemplary'.

The tone and content of the Hey and Chalmers article can be gauged from the first point in its summary:

"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."

The Griffiths report, which had been commissioned by the Department of Health, had begun the summary of its findings thus:

"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."

In their response, published in the British Medical Journal alongside the Hey and Chalmers article, Professor Griffiths and his collaborators began by saying that Hey and Chalmers.

"seem to have entirely misunderstood the terms of reference and the main thrust of their report."

This is enough to indicate why, in respectful disagreement with Auld LJ, I do not consider that this court can say that the medical literature disposed of any possible question of serious professional misconduct. Nor, however, can I accept Mr Havers' submission that it manifestly required a referral to the PCC. Even to adjudicate on this submission, given the patent conflict of evidence, would risk substituting the court for the PPC.

How the PPC dealt with the evidence

I would also hold, in agreement with Jonathan Parker LJ and for the reasons given by him, that by embarking on an evaluation of such evidence as it had, the PPC exceeded its powers.

Conclusion

In my judgment the only fair outcome is that the PPC should be reconstituted in order to do the job it has so far failed to do. It should make it clear first of all that, unless Professor Southall agrees to let the Henshalls see his submissions, if necessary on suitable undertakings, the submissions will be put aside. Secondly it should act on the published literature only if, having considered the Hey and Chalmers article alongside the Griffiths report, the Hull report and any other relevant material placed before it, it is satisfied that there is in sum no evidence capable of raising a question within s.11(2). It is not the PPC's task to evaluate conflicting professional views of issues raised by the complaint. Its final task is to apply, with whatever exegetic help it finds useful, the test set by rule 11(2): does the material advanced for and against the complaint raise a question whether one or more of these practitioners has committed serious professional misconduct?

I would accordingly allow this appeal and, with the co-operation of the parties, make such order as will produce the outcome I have indicated.

Lord Justice Jonathan Parker:

I too am grateful to Auld LJ for his account of the facts and for his exposition of the legal background to the appeal. However, like Sedley LJ, I have the misfortune to disagree with his conclusions. I agree with Sedley LJ that the appeal should be allowed, and the matter remitted to a reconstituted PPC for reconsideration.

The correct test

I agree with the judge, and with my Lords, that the PPC in the instant case identified the correct legal test as laid down in Rule 11(2) of the 1983 Rules, and as explained by Lightman J in Toth and by the GMC's Aide-Memoire dated 31 January 2001. As the judge observed in paragraph 70 of his judgment, the differing formulations of the test advanced (before him) by Mr Ian Wise and (before us) by Mr Philip Havers QC amount to no more than an exercise in semantics.

However, I consider that, having identified the correct test, the PPC failed properly to apply it to the material before it.

Under the heading 'Professor Southall', the decision letter dated 12 March 2004 records the following (in the passage quoted by the judge in paragraph 43 of his judgment):

"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 … considered that the information leaflet and consent procedures were adequate when judged by the standards in place at the time. In addition, the Committee considered that the participating staff had been satisfactorily trained and that Professor Southall could not be held responsible for the erroneous inclusion of Sofie in the trial." (My italics)

In my judgment, in making those findings the PPC went beyond the limits of its function as laid down in Rule 11(2). It is one thing to evaluate the available evidential material in order to determine whether in its opinion such material appears to raise a question whether the practitioner has committed serious professional misconduct, but (as it seems to me) quite another to purport to resolve disputed factual issues. I consider that in making the findings recorded in the passage from the decision letter which I have just quoted – and in particular the finding that the trial was properly conducted – the PPC went further than was necessary for the purpose of deciding whether the material before it raised the Rule 11(2) question. In so doing, it trespassed on an area which was properly the province of the PCC, should the case be referred to it.

Accordingly, I conclude that in the instant case the PPC exceeded its proper function as explained by Lightman J in Toth.

Non-disclosure of Professor Southall's response

Rule 16, as I read it, was only engaged once the PPC had decided not to refer the case to the PCC. By contrast, what we are concerned with in the instant case is the situation which obtains when, in the course the PPC's investigative process and before it has taken any decision on referral, the practitioner tenders evidential material to the PPC on terms that all or part of it is not disclosed to the complainant, or that disclosure to the claimant is subject to conditions (e.g. a cross-undertaking by the complainant not to disclose the material to third parties) which the complainant is unwilling to accept. In such a situation the PPC has, in my judgment, an inherent discretion whether or not to take such material into account in reaching its decision. Given that save in rare cases a complainant is entitled to an adequate opportunity to put his or her case (see per Bingham LJ in Cotton, in the passage quoted by the judge in paragraph 47 of his judgment), and that the PPC has a duty to act fairly, it seems to me that the PPC ought not to take such material into consideration in reaching its decision unless it is satisfied that there is good reason why it should do so notwithstanding that the complainant has not seen it and accordingly is not in a position to respond to it.

As I see it, therefore, it is not a question of ignoring the terms imposed by the practitioner in relation to disclosure of the material submitted: rather, the question is whether in all the circumstances, and given such terms, it is appropriate for the PPC to take such material into account in reaching its decision.

In the instant case the complainant was willing to give an undertaking not to make use of Professor Southall's responses in any other context, but Professor Southall did not consider that such an undertaking would afford him sufficient protection. Accordingly, he maintained his absolute prohibition on disclosure. That was a matter for him. However, the question then for the PPC was whether in all the circumstances, and given Professor Southall's absolute prohibition on disclosure, it was appropriate for the PPC to take his responses into account in reaching its decision. There is nothing to indicate that the PPC addressed that question. The judge (in paragraph 60 of his decision) concluded that the PPC had "proper grounds on which to refuse disclosure in Professor Southall's case"; but, as I have indicated, that seems to me to be a different question. In the circumstances I consider that there is a real risk that, in reaching its decision not to refer, the PPC took into account material (i.e. Professor Southall's responses) which, had it addressed the right question, it would have left out of account.

The Hey and Chalmers Article

I agree with Sedley LJ, for the reasons he gives, that the PPC exceeded its proper function in placing substantial reliance on the Hey and Chalmers Article, and the criticisms of the Griffiths Report which it contained. Like Sedley LJ, I cannot accept that, as Auld LJ puts it in paragraph 74 above, the Griffiths Report was effectively before the PPC. It was only before the PPC in its guise as the target for the serious criticisms made of it by Hey and Chalmers.

Note 1 i.e. before its extensive amendment by the Medical Act 1983 (Amendment) Order 2002, SI 2002/3135. [Back]