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FULL TRANSCRIPT

   1                    Day 48, 13th September 1999
   2   (11.00 am)
   3   THE CHAIRMAN: Good morning, everyone. Good morning,
   4     Mr Langstaff.
   5          OPENING STATEMENT BY MR LANGSTAFF
   6   MR LANGSTAFF: Good morning, sir. Sir, it is regrettable
   7     that we should have started the week in the way that we
   8     have by being half an hour late in beginning, and I hope
   9     I shall be borne out in the event by saying it is not
  10     the way we mean to continue the rest of the week.
  11        An explanation is due. There are two of them.
  12     One is that it emerged in the course of the discussions
  13     which we as Counsel to the Inquiry make ourselves
  14     available for, with witnesses and their representatives,
  15     that Sir Donald Irvine had the handicap of not having
  16     a numbered, referenced bundle of the very considerable
  17     documentation which we had, and that then had to be
  18     photocopied. Those seeing the size of the files behind
  19     me will recognise that that was not a quick task,
  20     particularly since he then had to be given the
  21     opportunity of knowing which document came at which
  22     page.
  23        Secondly, and this involves a slightly greater
  24     degree of explanation, I have had again, in accordance
  25     with our procedure, which is for any interested

   1     participant to ask questions through to us as Counsel to
   2     the Inquiry, a number of questions which have been
   3     delivered very late in the day, of some length, and it
   4     is right that I should say something about them.
   5        First of all, however late questions come, we are
   6     very grateful that they should come. That is the first
   7     point, and so nothing that I say hereafter should
   8     discourage anyone from giving me those questions. But
   9     the nature of some of the questions which I have had
  10     from interested participants on what one might describe
  11     as both sides of a debate, indicate something of
  12     a misconception, I think, about the evidence which we
  13     are entitled to ask Sir Donald about today. I think it
  14     would be most unfortunate if there were to be any
  15     misunderstanding or, indeed, if people should feel that
  16     in this respect the Inquiry had failed them.
  17        The law constrains us as to what we are entitled
  18     to ask Sir Donald Irvine about. We will not,
  19     therefore -- I will give the main reasons for it in
  20     a moment -- ask him about why it was that the GMC
  21     reached the decision it did in respect of Doctors
  22     Wisheart, Dhasmana and Roylance. Nor shall we ask him
  23     about the intimate discussions and considerations of the
  24     Panel which sat in deliberation at the GMC.
  25        There are number of reasons for this. The

   1     principal ones are these: first of all, this Inquiry is
   2     a different Inquiry from that conducted by the GMC. It
   3     is not relevant to this Inquiry to know why it was that
   4     the GMC reached its decision because this Inquiry has to
   5     reach a decision of its own, whatever that decision may
   6     be.
   7        The decision it has to reach is on a different
   8     question and for a very different purpose. Our terms of
   9     reference are to enquire into the management of care at
  10     Bristol, which is a much more wide-ranging question
  11     involving more than specific charges against three
  12     individual clinicians, and in respect of a much wider
  13     time-frame. It is of no more assistance to this panel
  14     to know how another body decided in respect of part of
  15     the picture than it would be, for instance, for a court
  16     to consider the finding of an inquest into how somebody
  17     met his or her death. It has long been established in
  18     law that the decision of the one body, though entitled
  19     to respect and established by law for a particular
  20     public purpose, is actually of no relevance to the
  21     ultimate decision that the court in that context has to
  22     make.
  23        Secondly, we are limited by our terms of reference
  24     to looking at matters which relate to the management of
  25     care between 1984 and 1995. The GMC's procedures and

   1     determination were outside that time-frame. So even if
   2     my first reason was not valid, we are not permitted by
   3     law to enquire into anything that happens after 1995.
   4     The only exception to that is that we may, of course,
   5     look at events since 1995 if they cast a particular
   6     light and help us to know what was happening between
   7     1984 and 1995, but otherwise, it is not part of our
   8     Inquiry so we are constrained.
   9        Thirdly, this Inquiry is not a Court of Appeal
  10     from the GMC. There is, as a number of people have
  11     asked me questions recognise, a route of appeal to the
  12     Privy Council. In the case of one of the doctors
  13     concerned, that route of appeal has been taken with
  14     results which I will then make public knowledge. We
  15     therefore have no function. We would be trespassing on
  16     the function of others if we were to conduct what was in
  17     the nature of an appeal against the decision of the GMC,
  18     but more than that, are actually constrained by a ruling
  19     of the Privy Council that the deliberations of the
  20     Professional Conduct Committee of the General Medical
  21     Council are immune from exploration, and it is
  22     a contempt contrary therefore to law to enquire into it.
  23        So the law prevents me from asking questions which
  24     might otherwise appear to be entirely natural to be
  25     asked.

   1        I think, sir, all that it remains for me to say is
   2     that none of what I have said is any fetter at all upon
   3     you and the Panel reaching a decision of your own, as
   4     you are not only entitled but bound to do, upon the
   5     totality of the evidence which, as I have indicated, is
   6     wider, lengthier and covers a greater time-scale and
   7     a great number of operations than did the evidence which
   8     we know was called before the General Medical Council.
   9        Sir, I hope that is helpful. I hope that it is
  10     not too disappointing to those who had seen our purpose
  11     in part in a different light, and I shall be happy if
  12     anyone wishes further explanation to make myself
  13     available, as will, I know, my co-counsel and solicitor
  14     to the Inquiry, should anyone wish further clarification
  15     about what I have just said. But I think it is
  16     important that should be on the record at the outset.
  17        Sir, with that introduction, may I ask Sir Donald
  18     Irvine to take the stand, please?
  19        Sir Donald, it is our practice to stand to take
  20     the oath.
  21            SIR DONALD IRVINE (SWORN):
  22            Examined by MR LANGSTAFF:
  23   Q. Sir Donald, you are Donald Hamilton Irvine, are you?
  24   A. I am.
  25   Q. You are the current President of the General Medical

   1     Council?
   2   A. I am.
   3   Q. Having first been elected to that post in 1995 and
   4     re-elected in May of this year?
   5   A. That is so.
   6   Q. Can we have on the screen, please, WIT 51/1? Is that
   7     the start of a statement which you prepared for the
   8     purposes of this Inquiry, addressing the questions you
   9     were asked to address?
  10   A. Yes.
  11   Q. Can we have please on the screen page 51/14?
  12        Is that, at the foot of the page, your signature?
  13   A. Yes.
  14   Q. That is where the statement ends. Are its contents true
  15     and accurate?
  16   A. Yes.
  17   Q. You refer in the statement to an earlier statement
  18     provided by Mr Finlay McMillan Scott, who I think is
  19     present today. Can we have that, please, WIT 62/1?
  20        That is the statement to which you refer, is it?
  21   A. Yes.
  22   Q. We see at 62/27, that he signs that and signed that on
  23     4th March of this year, and am I right in thinking that
  24     you accept and, in so far as it is necessary to do so,
  25     adopt what he says in his statement about as it were the

   1     "nuts and bolts" of the GMC?
   2   A. I do. I believe there has been an addendum as well.
   3   Q. Yes. The second statement he makes is 62/713 and that
   4     finishes at 62/717, dated 2nd September 1999, signed by
   5     Finlay Scott. Does what I said about his first
   6     statement apply to his second?
   7   A. Yes.
   8   Q. Would I be right in giving the date of that as
   9     2nd September and your own statement as the 3rd, that
  10     that second statement was made after discussion with you
  11     and perhaps to an extent in conjunction with you?
  12   A. It was.
  13   Q. Before I ask you questions, I understand that you want
  14     to make a brief statement?
  15   A. Thank you.
  16           STATEMENT BY SIR DONALD IRVINE
  17   SIR DONALD IRVINE: I am grateful to you for your opening
  18     remarks, which, in some senses, anticipate what I wanted
  19     to say.
  20        I am sure that the Panel and you, sir, will
  21     appreciate that I am precluded absolutely from speaking
  22     as to what occurred in the course of the Professional
  23     Conduct Committee in camera deliberations, and you have
  24     indicated so. I am also concerned that certain lines of
  25     questioning could lead people to draw the inference that

   1     the views I express here must be the views that
   2     I expressed in camera whilst I was acting as the
   3     Chairman of the Professional Conduct Committee engaged
   4     in the Inquiry into the Bristol doctors.
   5        I am sure you will understand my position,
   6     Chairman, and it would be quite wrong for anyone to be
   7     able to say as a result of what I say here that it is
   8     clear which way I voted on any particular aspect. You
   9     are no doubt conscious of the Privy Council judgment
  10     relating to the disclosure of the in camera
  11     deliberations. I hope therefore, Mr Langstaff, I will
  12     not be asked any questions which could take us down
  13     those avenues. If I feel or I perceive I am being asked
  14     along those lines, whilst I certainly want to be as
  15     helpful as I possibly can to the Inquiry, I may have to
  16     say that I cannot answer for legal reasons.
  17        That is all I wish to say.
  18   Q. Sir Donald, we will see how the questioning goes.
  19   A. Indeed.
  20   Q. If you and I come to a disagreement about the question,
  21     it will have to be resolved as and when it happens.
  22   A. Indeed.
  23   Q. At the bottom of WIT 51/1 there is a motto "Protecting
  24     patients, guiding doctors."
  25        For how long has that been the motto of the GMC?

   1   A. I think since 1995. I am open to correction on that.
   2     It is certainly later than 1995.
   3   Q. So the "protecting patients, guiding doctors", would
   4     appear to put patients first?
   5   A. It was a carefully considered decision to attempt to
   6     make clear where the priorities of the GMC lay. It has
   7     dual responsibilities both for doctors and to patients,
   8     and we wish, since there has clearly been ambiguity
   9     about where the priority might lay, that it lay actually
  10     with protecting patients. So it was in a sense an
  11     explicit statement to that effect, to help us and others
  12     concentrate our minds on that.
  13   Q. So it was seen, was it, in 1995, that there was
  14     ambiguity about whether the GMC put patients' interests
  15     first?
  16   A. There was a widespread perception of such ambiguity,
  17     both outside and at times inside the Council, and it
  18     seemed prudent to clarify.
  19   Q. Is what you are saying that there was a degree of
  20     movement towards adopting the motto, a development over
  21     the years in any event from 1984 to 1985, towards the
  22     privacy of the patient?
  23   A. Yes. I think you put it well in your question, in
  24     indicating change over a period of time. I of course
  25     have been a member of the Council during the time at

   1     which that change has been happening. By the time we
   2     came to 1995, it had moved to the point where we very
   3     much wished to make that absolutely explicit.
   4   Q. The GMC had been -- has been, I think in a number of
   5     quarters -- criticised in relation to at any rate the
   6     period before 1995, for appearing rather to protect
   7     doctors than to protect patients.
   8        To what extent, looked at now, do you consider
   9     that there was validity in those criticisms?
  10   A. I think that some of the criticisms stem from
  11     a misunderstanding or lack of understanding or
  12     appreciation of precisely what the functions of the GMC
  13     are, and the framework within which it works, what it
  14     can and cannot do.
  15        Perhaps I ought to say very briefly here, to
  16     provide that context that will inform the whole of my
  17     evidence, the GMC is governed by statute, by Act of
  18     Parliament, the 1983 Act is the defining Act, and what
  19     it does has to be done within that framework. The
  20     principal functions are to keep a register of doctors
  21     who are competent to practise in this country, to
  22     exercise some oversight of the basic medical education
  23     of doctors making students into doctors through the
  24     function of inspecting final qualifying examinations and
  25     our medical schools and our rather more diffuse function

   1     of co-ordinating all stages of medical education.
   2        The third function is to give advice to the
   3     profession on matters of standards and medical ethics
   4     from time to time, and as required.
   5        Fourthly, to operate the fitness to practise
   6     procedures by which, on complaint, we enquire into
   7     a doctor's practice where a doctor's registration may be
   8     called into question. As you know, there are three
   9     limbs to that part of the framework dealing with the
  10     conduct of doctors, with the doctors who may be impaired
  11     by ill-health and those now who may be impaired by
  12     performance.
  13        That framework, then, we have to strictly adhere
  14     to. It gives us powers to act decisively in some areas,
  15     but it places considerable constraints particularly at
  16     the operational level where the Council's
  17     responsibilities do not run.
  18   Q. Can I put perhaps some flesh on that? You have made
  19     I think a point in a number of articles and in a number
  20     of statements about the importance to the profession of
  21     audit?
  22   A. Of audit, yes.
  23   Q. You see the audit cycle, as I understand it, being
  24     a question of promulgating standards; of measuring what
  25     has been done, and then how far those measurements

   1     indicate that the standards have been achieved, with
   2     a view if necessary to changing performance in the light
   3     of the results?
   4   A. Yes.
   5   Q. In so far as the GMC is concerned, if one, as it were,
   6     were to look at an audit of its procedures and practices
   7     over the period that we were concerned with, I wonder if
   8     you can help me with some as it were basic statistics?
   9        In so far as competence is concerned, how many
  10     doctors' names were, during the period 1984 to 1995,
  11     erased from the register on the grounds of incompetent
  12     performance of their duties?
  13   A. Doctors during that period were erased on grounds of
  14     misconduct in a clinical area. I think I indicated that
  15     the proportion has risen over the years. I do not have
  16     the precise numbers, but of course I will supply those
  17     to you.
  18   Q. So misconduct aside, the poor performer has never,
  19     between 1984 and 1995, been erased from the register on
  20     the grounds of poor performance alone?
  21   A. A number of doctors have been erased from the register
  22     where their performance has been so unsatisfactory as to
  23     constitute serious professional misconduct in the GMC's
  24     eyes. But of course you touch on a fundamental weakness
  25     in the fitness to practise procedures, which we

   1     recognised in that period and set about a strengthening
   2     of the procedures by having the Medical Performance Act.
   3        It gave us the power to look at a doctor's pattern
   4     of practice over a period of time, but the basic fact of
   5     the matter is that we became aware that where a doctor's
   6     practice was manifestly unsatisfactory, it was
   7     nevertheless very difficult to bring a charge of serious
   8     professional misconduct and make it stick. This left
   9     the public exposed.
  10        So from here, there followed the whole of the
  11     development of the performance procedures, the statute
  12     was enacted in 1995 and those procedures are now
  13     operational.
  14   Q. So before the performance procedures, am I right or
  15     wrong in thinking that no doctor was struck off, erased
  16     from the register, on the grounds of poor or inadequate
  17     performance measured over a period of time in his
  18     practice?
  19   A. You are using the word "performance" in the very
  20     technical sense we now do, but putting it plainly, if
  21     you are saying were doctors struck off for making very
  22     bad clinical mistakes, of course they were.
  23   Q. So far as the complaints were concerned, roughly how
  24     many complaints a year between 1984 and 1995 came to the
  25     GMC for assessment by an assessor?

   1   A. The numbers, again, I will give you these precisely, but
   2     the numbers have risen steadily during the period.
   3     Towards the end of the period we were talking about
   4     1,500 or so complaints, as against the 3,000 complaints,
   5     for instance, which we have roughly now. There has been
   6     a steady increase. We have that documented and we will
   7     supply you with that information.
   8   Q. Of the complaints made, what percentage, roughly, were
   9     rejected at the scrutiny stage?
  10   A. In a recent audit, we established that just under 20 per
  11     cent of complaints were not really in a form that could
  12     be translated into a complaint upon which we could act
  13     or even enquire. For example, since we are concerned
  14     with specific doctors, there would be no named doctor or
  15     the matter would be about institutional questions which
  16     were not within our terms of reference.
  17        Beyond that fifth, roughly 100 cases a year
  18     reached the Professional Conduct Committee, but I will
  19     give you the precise figures so there is no ambiguity.
  20   Q. So one is looking broadly speaking by the end of the
  21     period, you say there were 1,500 complaints, of which
  22     roughly 100 would get through the Professional Conduct
  23     Committee and that would be in the region of about
  24     6 per cent. Had the portion varied much in the years
  25     1984 to 1995?

   1   A. Can you clarify? Do you mean the proportion of cases
   2     which had a clinical content?
   3   Q. The portion of complaints reaching the PCC, was it
   4     always about 6 per cent, roughly?
   5   A. Roughly, to the best of my knowledge.
   6   Q. So far as the GMC is today constituted, how many
   7     complaints roughly per year presently come before the
   8     Professional Conduct Committee?
   9   A. The proportion is rising but at the present time, it is
  10     roughly the same. But of course this is now a distorted
  11     picture because the performance procedures are in
  12     operation and beginning to affect the picture. That is
  13     to say, more cases are being considered where there
  14     appears to be a question about a doctor's registration
  15     than formerly. I have given you some numbers to
  16     indicate roughly how that element is increasing.
  17        In addition to this, to complete the picture, we
  18     must not forget there are other doctors who come into
  19     the health procedures where equally there is a question
  20     about their registration.
  21   Q. So in terms of overall numbers coming for a hearing
  22     before the Professional Conduct Committee, roughly how
  23     many do you expect in a chronological year now?
  24   A. Roughly 100.
  25   Q. And how many extra would you add to that for those cases

   1     coming before the Committee on Professional Practice?
   2   A. In the year in which this has been operating, there have
   3     been three, but this is utterly misleading. There are
   4     75 cases in the pipeline.
   5        We had anticipated that there would be more. We
   6     planned our procedures on the basis that there would be
   7     more, but of course as you will know, the legislation
   8     was not retrospective; a pattern has to be established
   9     in order to trigger a complaint.
  10        My understanding is that that in part at least
  11     accounts for the fact that the build-up has been
  12     relatively slow.
  13   Q. So a total, one anticipates for next year, if one puts
  14     conduct and practice into one pot, of 175 cases. What
  15     about the ill-health?
  16   A. The proportion has remained roughly the same. We had
  17     about 800 doctors in or around the health procedures.
  18     You know that some are supervised by our health
  19     screeners, and others are where there is a dispute by
  20     the doctor as to whether -- basically whether they are
  21     willing to accept conditions put upon them when they go
  22     before the Health Committee.
  23        But what I will do, I will be able to give you
  24     precise answers to this question too, and indeed during
  25     the course of the hearing today, we will bring that

   1     information to you.
   2   Q. I am grateful. Can you indicate how many health cases
   3     actually come for a hearing before the Health Committee?
   4   A. It is a small proportion. I cannot tell you the exact
   5     proportion, but I will give you that. It is a smaller
   6     proportion of the whole. Most doctors under the health
   7     procedures accept the need for supervision and enter
   8     into that agreement.
   9   Q. So are we looking in terms of actual hearings putting
  10     together the present position in respect of conduct,
  11     practice and health, at a figure anticipated for next
  12     year of round about 200 hearings?
  13   A. Possibly more.
  14   Q. By much, or is that broadly the range?
  15   A. I cannot answer that accurately. I simply do not know
  16     what the pattern of increase in performance is going to
  17     be. Our original estimates based upon assessments we
  18     made about possible problem areas in practice suggested
  19     that it would be much higher. We are still basing our
  20     plans on that assumption.
  21   Q. If one takes a figure, then, of 200 to 300, allowing for
  22     a 50 per cent increase in the numbers, that would be,
  23     today, looking at the period 1984 to 1995, roughly how
  24     many hearings, all told, in terms of conduct and health,
  25     were there on average per year? It has to be a broad

   1     figure; it is just a feel for it that I am after.
   2   A. Again, I prefer to give you the exact figures later in
   3     the morning, but if I tell you that the hearings of the
   4     Professional Conduct Committee have gone from relatively
   5     infrequently, certainly as the Council began, through in
   6     the last ten years to regular hearings. If you were
   7     a doctor on the Conduct Committee, you expected to set
   8     aside three to four weeks for these hearings, to
   9     a position today where we are in virtually continuous
  10     session and we are making arrangements now, given the
  11     rising number of references from our preliminary
  12     proceedings to arrangements to run panels of the Conduct
  13     Committee in parallel. It is a huge increase. And of
  14     course, added to that is the fact that the complexity of
  15     the cases has also added to length.
  16   Q. If one were to ask what the number of registered doctors
  17     was -- and obviously exact figures again will be
  18     available -- from 1984 to 1995, what ball-park figure is
  19     there likely to be?
  20   A. Of the total doctors on the Medical Register, the
  21     ball-park would be around 180,000. But of those, around
  22     100,000 practise in the National Health Service. Many
  23     of our registrants are overseas or retired. The
  24     operating figure for this country is effectively
  25     100,000.

   1   Q. So if, for the sake of example, let us suppose in the
   2     1980s there was an average of 100 hearings per year,
   3     that would be approximately one-tenth of 1 per cent of
   4     the total number of registered doctors in the country?
   5   A. It is a very small proportion. It is not a reflection
   6     of, of course, complaints made against doctors. The
   7     purpose of our hearings is to enquire into circumstances
   8     where a doctor's registration may be called into
   9     question. Hence the phrase "serious professional
  10     misconduct".
  11   Q. If one were, therefore, to get a feel for the system,
  12     bearing in mind what you have just said, does the
  13     proportion, do you think, represent an absence of proper
  14     complaint about doctors and their practice on the one
  15     hand, does it represent the possibility that doctors,
  16     all bar a tiny percentage, probably faithfully all
  17     discharge their professional obligations, or does it,
  18     would you say, indicate something of a shortcoming in
  19     the procedures because they are too restrictively drawn,
  20     or a mixture of those factors?
  21   A. I think it may be fairly said as a mixture of those
  22     factors, but an important part of context in this has to
  23     be the number of complaints which are brought against
  24     doctors working in the National Health Service. The
  25     majority of doctors registered in this country do work

   1     in the National Health Service. So patients, for
   2     instance, who wish to complain about a general
   3     practitioner, their family doctor, are more likely in
   4     the first instance to go to the appropriate Health
   5     Authority, and those complaints are dealt with there.
   6        There may be an onward reference in some
   7     instances, but many of these cases are dealt with
   8     exclusively in the Health Service and there are
   9     comparable arrangements within the hospital field.
  10        So it would be misleading in the extreme to think
  11     that the only source of both complaint and an indication
  12     of the volume of complaint were the GMC procedures. One
  13     has to look at the wider picture as to how the public
  14     sees these things and where they go.
  15   Q. Taking away, as it were, your GMC hat for a moment, if
  16     one were to look at the system of regulation as a system
  17     involving the GMC, the employer, that is the National
  18     Health Service or the Trust as may be the case, and the
  19     other regulatory body such as the Ombudsman, the court
  20     system and so on, would you describe the period from
  21     1984 to 1995, at any rate, as one in which the system
  22     was co-ordinated in any way between those regulatory
  23     bodies?
  24   A. Co-ordinated up to a point, but I have expressed my
  25     opinion about this in public before. I do not believe

   1     the system was as well co-ordinated as it might have
   2     been, or should be.
   3   Q. Can I pick up on the two elements in which you criticise
   4     the system as it was from 1984 to 1995, or may criticise
   5     it. One of those is the co-ordination or lack of
   6     co-ordination which you mentioned in response to my
   7     question, and the second is your acceptance that part of
   8     the picture for the absence of complaint may have been
   9     the fact that the complaints procedures were too
  10     restrictive.
  11        Can I ask you about that latter first? Again, in
  12     general terms, dealing with the period 1984 to 1995,
  13     what about the disciplinary procedures that the GMC had
  14     that was too restrictive in respect of what one might
  15     loosely describe as the available pool of complaint?
  16   A. I think there has been undoubtedly a perception that
  17     they may be too restrictive, and that has been revealed,
  18     manifest, in comments, for instance, about the level of
  19     the threshold at which complaints may be taken forward
  20     and hearings and action triggered. That is absolutely
  21     true.
  22        That has found expression, I think for instance,
  23     of Mr Nigel Spearing and his Private Members Bill, in
  24     the early 1980s, I cannot remember exactly; we can check
  25     that. But his Bill and his solution was to try and open

   1     up the procedures to make the conduct -- I think he
   2     sought a serious conduct rather than -- a conduct rather
   3     than serious professional misconduct to lower the
   4     threshold.
   5        So that sort of debate has certainly been alive
   6     inside the profession, and publicly.
   7   Q. So one way in which the procedures may, you think, have
   8     been too restrictive was because of the use of the word
   9     "serious" in front of the words "professional
  10     misconduct"?
  11   A. Yes, that is one reason, but I think I have also
  12     mentioned in my evidence that from a patient's point of
  13     view, there is a greater difficulty. Most patients do
  14     not start asking themselves with a complaint "Is this
  15     likely to be serious professional misconduct or not?",
  16     they want to know what to do and where to go and have
  17     the thing taken forward. I think for many patients,
  18     then, a difficulty has been knowing how to get started,
  19     who is responsible for what, and we are back to this
  20     question of co-ordination.
  21        We feel really quite strongly about that, and in
  22     fact that is a matter which I have raised with the
  23     Secretary of State quite recently, that that needs to be
  24     pursued and we are pursuing it. It is almost as though,
  25     two systems running in parallel, it was possible for

   1     people to fall through the middle, and that is eminently
   2     not satisfactory.
   3        So, addressing that problem in the period to which
   4     you refer is, I think -- I speak personally -- a matter
   5     of urgency, and it requires the co-operation of all
   6     concerned. How do we make it as simple as possible and
   7     as easy as possible for people to take a proper
   8     complaint forward?
   9   Q. We will come to the question of transparency or ease of
  10     access to a complaints procedure in a moment or two, but
  11     looking back at the restrictive influences in the past,
  12     one is the use of the word "serious". The standard of
  13     proof which the GMC adopted between 1984 and 1995, and
  14     I think still does, is "beyond reasonable doubt", is it
  15     not?
  16   A. That is correct.
  17   Q. If the object is to protect patients, one would wish to
  18     eliminate any unnecessary risk to a patient, would one
  19     not?
  20   A. I agree.
  21   Q. The existence of an unnecessary risk is, by definition,
  22     something which should be avoided?
  23   A. Of course.
  24   Q. How does one properly protect patients if the risk has
  25     to be not so much a serious risk but a risk of seriously

   1     deficient practice or conduct? Can one properly do it?
   2   A. No, and if one were to pursue this line of argument, one
   3     would run into a blind end. It is for precisely this
   4     reason that we have undertaken some very radical
   5     thinking indeed about how to address the problem,
   6     because you have talked about prevention; you simply
   7     cannot get at a preventative strategy if one relies on
   8     a complaints-driven system alone. It leaves far too
   9     many questions asked about practice which is, I know, of
  10     concern to members of the public which would fall into
  11     a kind of grey area of not very good practice, but
  12     perhaps not bad enough to remove a doctor altogether
  13     from the medical register or for an employer to
  14     discharge the doctor. I know that this causes great
  15     concern to people.
  16        So we have to find a better way, and you only do
  17     that by exploring a completely different avenue.
  18        If one can therefore say, in order to ensure that
  19     the Medical Register means what it says, doctors, men
  20     and women on the Medical Register, are today when the
  21     patient goes to see the doctor in the surgery or at the
  22     hospital, as up to date and fit as possible. One needs
  23     to think of the kind of mechanisms whereby that would be
  24     achieved, both managerial and professional.
  25        If one starts from that end then, where the

   1     complaints procedures fit acquires an altogether
   2     different significance and the question of the threshold
   3     acquires a different significance as well.
   4        I should just add lastly, that of course in terms
   5     of the seriousness of a doctor appearing before any
   6     fitness to practise committee of the GMC, the
   7     consequences for the doctor are serious indeed. They
   8     are about loss of everything in the ultimate. That of
   9     course is where the standard of proof has continued to
  10     rest and why.
  11        So I am merely saying, we came to the conclusion
  12     in the early 1990s -- this has been an unfolding
  13     development, a fundamental development since then, that
  14     reliance on fitness to practise, complaints alone, would
  15     not give the kind of protection that people expect.
  16   Q. So what you are describing is a system of
  17     after-the-event punishment, the GMC being the punitive
  18     arm of the profession historically, rather than a body
  19     which thus far has, by its presence in procedures,
  20     prevented the practice of inadequate medicine?
  21   A. Yes. I think what the GMC has been able to do by its
  22     statutory power is to be able to give advice, and it has
  23     done that in an increasingly cogent way. A fundamental
  24     change to that was developed in the 1990s and culminated
  25     in the adoption of explicit values and standards as

   1     distinct from implicit standards and values, set out in
   2     Good Medical Practice. But it is not empowered to
   3     exercise a day-to-day monitoring of doctors at work.
   4     That responsibility has always fallen to the employers.
   5        I think I have drawn attention elsewhere too, to
   6     the fact that in the system of medical regulation, as
   7     distinct from professional self-regulation, which is one
   8     part of it, we have become increasingly aware of the
   9     extent to which, then, these local arrangements are
  10     fundamental, both to assuring good practice, preventing
  11     things going wrong, and when things do appear to be
  12     going wrong, being able to act promptly and effectively
  13     before harm is done, either to patients or indeed the
  14     doctor. I have set out that sort of argument in the
  15     first of the two annex papers, the British Medical
  16     Journal. I base that kind of analysis on the very
  17     excellent work of people like Professor Marilyn
  18     Rosenthal, who have made studies of how medical practice
  19     has regulated where doctors work. It is a fundamental
  20     change in thinking.
  21   Q. Marilyn Rosenthal, in one of her writings, 1987 -- I am
  22     not sure if we yet have this scanned in. It is being
  23     scanned in at the moment. I will have to come back to
  24     that, I am sorry.
  25        So far as standards then were concerned during

   1     1984 to 1995, standards of good practice, we have heard
   2     from the evidence given to us by the Royal Colleges that
   3     they would promulgate the standards in their own
   4     particular specialisms. Much of the evidence that we
   5     have heard suggests that there was a vacuum when it came
   6     to the enforcement of those standards. Is that how you
   7     would have seen the years 1984 to 1995, or not?
   8   A. The enforcement by the Royal Colleges, do you mean?
   9   Q. Enforcement generally.
  10   A. In general terms, yes.
  11   Q. So far as local level enforcement is concerned, by
  12     a Trust or by NHS management before Trusts were
  13     inaugurated, the problem that we have heard evidence of
  14     is that when a complaint would be made about the quality
  15     of practice or the conduct of a given clinician in
  16     a hospital, it would be left essentially as a matter of
  17     medical opinion and medical advice and medical
  18     regulation, either through the "three wise men"
  19     procedure, or if it went to management, that local
  20     management would say, "This is not a management matter;
  21     this is a medical matter so we have no right to do
  22     anything about it without involving the doctors". This,
  23     I think, is familiar territory to you, is it?
  24   A. Yes.
  25   Q. We have heard it suggested, amongst others by

   1     Dr Halliday from the Department of Health, that in
   2     looking to the doctors, the national management and
   3     local management would ultimately look to the General
   4     Medical Council. Is that the way that it worked?
   5   A. I am not absolutely sure what he means by that.
   6     I wonder if you could just explain further? If in every
   7     instance of a complaint one would look to the General
   8     Medical Council; is that the suggestion?
   9   Q. What he said was the Secretary of State was not
  10     responsible for the way that medicine was practised --
  11     this is Day 13, page 79, line 7, for reference
  12     purposes. He said that was for the General Medical
  13     Council, so he placed the responsibility for the way in
  14     which medicine was practised upon the General Medical
  15     Council.
  16        From what you are saying, I think you would say
  17     "That is asking too much of us, because we were the
  18     long-stop"?
  19   A. What I am saying is that, we have to operate within our
  20     framework.
  21   Q. Absolutely.
  22   A. Our framework did not include the management of doctors
  23     at work. The relevant framework is giving advice on
  24     standards of practice and promulgating those standards,
  25     seeking to inform the culture of practice, particularly

   1     through the education system and that part which we are
   2     specifically responsible for, and acting on the basis of
   3     complaint when things appear to have gone wrong.
   4   Q. At the hospital, the local management level, was it
   5     a consequence of clinical freedom that the local
   6     manager, if he was a manager and not himself
   7     a clinician, or herself a clinician, would have to take
   8     medical advice as to whether or not the standards were
   9     improper, inappropriate, and so on?
  10   A. One would expect so.
  11   Q. So inevitably, whether at a local level or at a national
  12     level, the profession was self-regulating?
  13   A. Unquestionably the profession, and doctors, had very,
  14     very considerable influence on what constitutes or does
  15     not constitute appropriate practice. That is absolutely
  16     true. I mean, that is the basis, whatever the
  17     regulatory framework, it starts from the question of
  18     being able to recognise good practice and serious
  19     departures from it. As the complexity of medicine has
  20     increased, so that task has become more and more
  21     difficult and one is dependent more and more on the
  22     expertise of people who actually know that.
  23   Q. In terms of the procedures available at local level, if
  24     a consultant were involved, that would be circumscribed
  25     by documents such as HC 99?

   1   A. The NHS has a statutory framework, that is correct.
   2   Q. Which it might be said was slow and cumbersome in
   3     reaching any resolution of what might be a difficult
   4     problem?
   5   A. I have no personal knowledge, in particular with my
   6     background in general practice, of the operation of this
   7     system in detail. I can only say from general
   8     impression that there was considerable variation in how
   9     that might be applied and how people approached the
  10     problems.
  11   Q. So it would depend, really, in the nature of local
  12     management, would it?
  13   A. In the nature of local people, including local
  14     management.
  15   MR LANGSTAFF: Sir, I am very much in your hands, Chairman,
  16     as to when you would wish to take a short break in the
  17     morning, bearing in mind that it will probably be
  18     sensible to have a lunch break some time no later than
  19     a quarter past 1.
  20   THE CHAIRMAN: I had briefly given my mind to this and
  21     wondered whether I might propose the following,
  22     I believe it is now in your possession in the form of
  23     a small yellow slip, that we continue until 12.30 and
  24     then take a break at around a conventional lunchtime,
  25     for 45 minutes, and then go on through the afternoon as

   1     I have indicated with our normal quarter of an hour
   2     break halfway through the afternoon. Would that be
   3     satisfactory first of all to the witness, and then to
   4     those who are with you and behind you? Would that be
   5     satisfactory to everyone?
   6   SIR DONALD IRVINE: Yes, thank you.
   7   MR LANGSTAFF: Sir, if I can just announce the prospective
   8     timings: that we finish this session at 12.30, have
   9     a break until 1.15, and then have a session from 1.15
  10     until 2.30, and then see where we are.
  11        I was exploring with you the nature of the way in
  12     which inadequate practice might be regulated by the one
  13     branch or other of the regulatory bodies, taking as
  14     a given that the GMC is really the end of the road, the
  15     long-stop. I have it right, have I? That is
  16     essentially how the GMC sees itself?
  17   A. Yes, although I qualify that: within the statutory
  18     framework that I have described, we have been undergoing
  19     a considerable change of outlook ourselves which began,
  20     again, in the early 1990s, and that was effectively to
  21     see how far within the framework, the statutory
  22     framework as it was, we could be as effective as
  23     possible.
  24        That change of view was occasioned by our
  25     understanding that couching advice to the profession in

   1     fairly negative terms, in terms of what doctors could
   2     not or should not do, seemed to be unsatisfactory, that
   3     there had to be a better way of doing this because one
   4     effect of that policy was to leave doctors feeling that,
   5     "Well, since I am clearly not bad, none of this advice
   6     applies to me".
   7        This recognition was coupled also with our
   8     understanding that the culture of medicine needed to
   9     take far greater account of patients, what patients
  10     thought about doctoring, what they expected of their
  11     doctors, and there seemed to be a gap, as it were,
  12     a mismatch here between the public and its confidence in
  13     the kind of advice given and the advice that we were
  14     actually giving.
  15        Thirdly, it was triggered by the issues of
  16     advertising, which do not seem central to performance,
  17     but nevertheless, the examination that we made at the
  18     time and the questioning about doctors' advertising led
  19     us in, I think it was 1991, really to put as central the
  20     whole question, for instance of information to patients,
  21     to discard much of the conventional thinking which was
  22     restrictive, and it was that kind of way of thinking
  23     which then encouraged us and led us to think that we
  24     ought to address our remarks more positively and more
  25     explicitly to the whole profession about their duties

   1     and responsibilities.
   2        The last point -- it is very fundamental to the
   3     notion of self-regulation, but that is not an end in
   4     itself, only a means to getting the best care for the
   5     patient -- was to make explicit that which had always
   6     been implicit in medicine, and that there is a contract
   7     between doctor and patient and that a registered
   8     practitioner, in accepting the privileges of being
   9     registered, which includes the ability to earn one's
  10     livelihood as a doctor, enters into certain obligations
  11     to the patient, to the public, as a result.
  12        It is that kind of thinking, Mr Langstaff, which
  13     was a million miles away from the very restrictive
  14     interpretation that we had traditionally placed on
  15     matters earlier.
  16        It was in tune, lastly, with the more general move
  17     in medicine towards being explicit about good standards
  18     of practice wherever possible. The whole guidelines
  19     movement as you know was developing at that time, and
  20     I have given some background to that in Annex B to my
  21     evidence.
  22   Q. As you know, and as the wider audience will have
  23     appreciated, your statement is to be taken as read, so
  24     the questions I ask are supplemental to it, but in
  25     essence the points which I think you would accept in

   1     respect of the way in which the GMC had a place in the
   2     regulatory framework from 1984 to 1995 are these: that
   3     first it was punitive rather than preventative; you have
   4     already accepted that?
   5   A. Yes.
   6   Q. Secondly, it was -- it may be the same thing -- reactive
   7     rather than proactive?
   8   A. Yes.
   9   Q. Thirdly, the standards that it promulgated were
  10     standards which were negative rather than positive:
  11     "thou shalt not", rather than "thou wilt"?
  12   A. Yes, I qualify that only in the sense that particular
  13     aspects of the standards were as apposite now as then,
  14     and in fact many of them found their way into the
  15     present guidance, so it is the presentation and
  16     direction which changed.
  17   Q. So far as the "thou wilt" part of it was concerned,
  18     standards tended to be unspoken rather than prescribed
  19     by the GMC, or for that matter by the Royal Colleges?
  20   A. That was the position in medicine as a whole, both in
  21     this country and elsewhere. Much of medicine, until the
  22     late 1980s, was based on implicit standards, the
  23     movement to explicit standards is relatively recent.
  24   Q. With those particular features in mind, I want to ask
  25     you about what information we can derive looking back

   1     historically from the way in which the guidance given by
   2     the General Medical Council in its publications Good
   3     Medical Practice, may shed light upon what actually was
   4     the position from 1984 to 1995.
   5        If I can ask you first to have on the screen
   6     51/103, it is the very last page, page 18, I should say,
   7     of the 1998 guidance. Paragraph 57:
   8        "To have an absolute duty to conduct all research
   9     with honesty and integrity."
  10        Can you explain to me how an absolute duty differs
  11     from a duty?
  12   A. I think it is a matter of emphasis.
  13   Q. When one looks to the earlier paragraphs of the booklet,
  14     I think one does not find the word "absolute", one just
  15     finds "duties".
  16        Is it the case that the proactive duties which are
  17     set out earlier in the booklet have the same force and
  18     emphasis as does paragraph 57?
  19   A. Yes.
  20   Q. So although the word "absolute" is there, it is a word
  21     which might as well not have been there in terms of
  22     making any difference of approach to one area rather
  23     than the other?
  24   A. You are quite right.
  25   THE CHAIRMAN: Just to clarify that point, could it be

   1     said -- I have no knowledge of this -- that the use of
   2     the word "absolute" here is to suggest that there is no
   3     discretion ever to depart from that duty whereas in
   4     other cases there may be a discretion under certain
   5     circumstances? Could that be a reason? I ask without
   6     knowing the answer.
   7   A. I do know that the issue of research misconduct has
   8     exercised us a great deal, and we have been very
   9     conscious of the need to promulgate as clear advice as
  10     possible that research has to be conducted with honesty
  11     and integrity, for the consequences of not doing so are
  12     fundamental. And to get that message as clear as
  13     possible, I think, lies behind this point.
  14        Of course, it is reflected in the inference that
  15     is drawn from these standards. It is known, for
  16     instance, that if a case is brought and found proved,
  17     the doctor may expect to be erased unless there are
  18     remarkable reasons why not.
  19   MR LANGSTAFF: Can we, with that in mind, look back at the
  20     duties and entitlements which begin at page 95 on the
  21     1995 Good Medical Practice.
  22        What I would like those who are showing the screen
  23     to do is to take the left-hand side of this page, move
  24     it to the left and have a split screen with page 124 on
  25     the left-hand side.

   1        On the left-hand side we have the 1995 statement;
   2     on the right-hand side we have the 1998, so we can see
   3     the development of the guide from 1995 to 1998.
   4        In both, of course, we begin with the entitlement
   5     to good standards of practice and care, and that has
   6     always been the entitlement of patients, has it not?
   7   A. Yes.
   8   Q. So this is making explicit that which would have been
   9     implicit, was it?
  10   A. Yes.
  11   Q. Essential to good standards of practice and care are
  12     said to be professional competence. That has always
  13     been the case, has it?
  14   A. Yes.
  15   Q. Good relationships with patients and colleagues, and
  16     observance of professional ethical obligations.
  17        So any patient would have been expected at any
  18     stage, even from 1984 and 1995, to professional
  19     competence as an entitlement as part of the standard of
  20     practice which a doctor professionally had to deliver to
  21     him?
  22   A. That has always been the case.
  23   Q. Then a difference I want to ask you about, under how
  24     "good clinical care" is described.
  25        In 1995, you must take suitable and prompt action

   1     when necessary and this must include ...", and three
   2     matters are noted. There is a change in the drafting.
   3     In 1998 it is "good clinical care must include ..." and
   4     "suitable prompt action" becomes the third of the
   5     bullet points.
   6        What is the reasoning behind the change of
   7     drafting?
   8   A. Simplification and economy of words, I think. There is
   9     no significance attached to the question of suitable and
  10     prompt action. I am conscious of the fact that I was
  11     not a member of the Standards Committee when the
  12     detailed work of drafting was done, but I am conscious
  13     of the fact that they were seeking to build on the known
  14     strengths of this guidance, which was its extreme
  15     simplicity and directness.
  16   Q. So this is purely presentation?
  17   A. I am sure it is.
  18   Q. Can we have another split screen? I want the right-hand
  19     side of 195, please, and the right-hand side of 124.
  20        Keeping up to date, paragraph 5: again there is
  21     a difference in the drafting. You see on the right-hand
  22     side in the 1998 version, "You must keep your knowledge
  23     and skills up to date throughout your working life",
  24     that is the duty, "in particular ..."
  25        In 1995, on the left-hand side, "You must maintain

   1     the standard of your performance by keeping your
   2     knowledge and skills up to date."
   3        So one is looking at keeping skills and knowledge
   4     up to date as an absolute duty, or a duty; the other is
   5     looking to the maintenance of standard of performance,
   6     as part of which the keeping of knowledge and skills up
   7     to date is an expectation.
   8        Again, are we looking at a drafting change, or is
   9     this something that occurred in discussion as to the
  10     change from one to the other?
  11   A. I mean, the significance of the difference between these
  12     two sessions is that there was a tightening of the
  13     guidance. That was the intention.
  14   Q. How do you see the tightening?
  15   A. I think part of the 1998 one is not on the screen.
  16   Q. We can have a look at it, certainly.
  17   A. Can I just look first? I am looking at the 1998
  18     guidance, the section, paragraphs 5 and 6 on keeping up
  19     to date, but then there is a presentational change which
  20     actually represented a change of emphasis and substance,
  21     because it then goes on to a specific heading,
  22     "Maintaining your performance".
  23   Q. We can have that, if you will just give me one moment.
  24     Can we take the right-hand side, please, of the screen
  25     and replace it with page 96, the left-hand part? That

   1     is what you had in mind?
   2   A. Yes, I mean, essentially the 1995 guidance has
   3     a three-paragraph section called "Keeping up to date."
   4        We did not think that that gave adequate focus on
   5     the matter of the doctor's performance, so a new
   6     section -- the thing was subdivided to heighten this.
   7     There are also drafting changes as you will see in
   8     paragraph 7 about audit.
   9   Q. Yes. I was going to ask you about that, because that is
  10     again a considerable change from what there was earlier.
  11   A. That is correct.
  12   Q. So between 1995 and 1998, the explicit statement, making
  13     plain that which was implicit, was to give a greater
  14     emphasis to the maintenance of performance and a greater
  15     emphasis to the need as a professional obligation to
  16     take part in regular and systematic medical and clinical
  17     audit?
  18   A. That is correct.
  19   Q. Does it follow that, as from 1995 to 1998, there had
  20     been a change towards where we are now, that in the
  21     years leading up to 1995 there would have been a similar
  22     trend?
  23   A. Would you clarify that, please?
  24   Q. Certainly. May I conclude that there has been an
  25     increasing emphasis through the 1990s on maintaining

   1     performance?
   2   A. Yes.
   3   Q. It is the corollary of that that if one were to take
   4     a snapshot in 1992, one would have a lesser emphasis on
   5     the maintenance of performance than one would in 1995?
   6   A. It has been a continuously evolving process.
   7   Q. If one goes back to the 1980s, one would have, it
   8     follows, a lesser emphasis still?
   9   A. Yes, that is correct. That is a reflection of the state
  10     of development of clinical audit and clinical
  11     standards. They are set in the wider context.
  12   Q. It is part of my reason for taking you to 1995 and 1998
  13     documents to see what they may show us of the trends
  14     between 1995 and 1998 with a view to extrapolating to
  15     the years before 1995 and asking whether those trends
  16     are now merely continuing the trend that there was then
  17     with the consequence that, then, there was less of an
  18     emphasis than there may be now on certain aspects of the
  19     obligations of a doctor.
  20        You follow the purpose of the questioning?
  21   A. I do. I think I ought to make a general point about the
  22     guidance here. It is the policy of the GMC,
  23     particularly in this form of guidance, to try to stick
  24     as far as possible to matters of principle and of
  25     fundamental importance.

   1        To that extent, there is a tendency not to include
   2     in the guidance that which may be still of unproven
   3     value or at a formative stage not yet received as
   4     a fundamental part of practice.
   5        We are constantly enjoined from all quarters to
   6     elaborate on this guidance and to reflect some of those
   7     developments and we resist this absolutely firmly
   8     because the strength of it -- and we have discovered the
   9     extent of the strength of it from the many users of it,
  10     doctors, managers and patients -- lies in its very
  11     simplicity. This is a point made time and again.
  12        So if things appear in here, you expect them to be
  13     followed.
  14   Q. You have mentioned "formative process" and you have
  15     mentioned "received principles".
  16   A. Yes.
  17   Q. Is it right, then, to conclude that what one sees here
  18     in the Good Medical Practice is something which enjoys
  19     a broad consensus of the doctors?
  20   A. Yes. We have corroborated that. In 1997 we
  21     commissioned work which included sampling,
  22     a representative sample of doctors. This was in the
  23     course of laying some baseline data for our performance
  24     procedures and how effective they may be, to find out
  25     from doctors their perceptions of the duties of a doctor

   1     as set out on the inside page. There was a remarkable
   2     degree of alignment between the sample and the
   3     statements and duties of a doctor, the questions were
   4     phrased, "Would you consider the breach of any of these
   5     duties to be a matter which ought to attract sanction?"
   6     But it also illuminated a gap in one important area,
   7     which was in the broadest terms to do with relationships
   8     with patients, communications. That cluster of matters
   9     and the relationships with patients, where there was
  10     evidence of a divergence between the GMC and the
  11     profession, with fewer doctors, 43 per cent, I think --
  12     I can give it to you accurately in my notes, if you
  13     wish, but a bigger proportion of doctors who did not see
  14     the issue of relationships with patients as being of
  15     such weight in the totality of the medical consultation
  16     as to attract sanction if things went seriously wrong
  17     with it.
  18        That sort of intelligence which is again a new
  19     step for the GMC, finding out how our guidance is
  20     received, is important intelligence for us, because it
  21     indicates where the gaps are. It is very interesting,
  22     of course, and very important, because it coincides with
  23     one of the areas from the public, from the patients,
  24     where they say medicine is out of tune with society.
  25     Once one begins to dip into the sample and explore it in

   1     this way, one begins to understand the reasons why, and
   2     on that basis, of course, that you can then prepare for
   3     further action.
   4   Q. What you have been saying is that the Good Medical
   5     Practice booklet reflects present views as to what
   6     good medical practice is?
   7   A. Yes.
   8   Q. In setting out standards, then, it does not seem to lead
   9     the standards; just reflect them?
  10   A. No. It is seeking to lead on standards --
  11   Q. But standards which already enjoy a broad consensus
  12     because this reflects the existing view?
  13   A. But nevertheless, to lead on standards. If one looks at
  14     any development in medicine, it starts with a few
  15     people, a new development, something new is developed,
  16     it acquires a greater significance, people research it,
  17     they write about it and so on and so forth. There comes
  18     a point where it becomes embodied into medical practice,
  19     but here is an example with medical and clinical audit,
  20     if you wish, or in the second bullet point, appraisal of
  21     your professional competence: appraisal is not
  22     a mainline piece of medical practice at the moment.
  23     We wish it to become so. We expect it to become so.
  24     We have made that explicit now.
  25        So there is a matter of leading professional

   1     opinion, given the heterogeneous nature of professional
   2     opinion. I have offered you also the latest guidance on
   3     consent. That most certainly leads rather than is
   4     a reflection of a wide spectrum of agreement.
   5        I want to make one other point. You have raised
   6     the matter of "representative of the views of the
   7     profession". We attach great importance to the things
   8     that this guidance says being acceptable to the
   9     patients, to reflect things that patients think are
  10     important, and in constructing this guidance, we set
  11     about seeking public opinion, patients' opinion, to an
  12     extent that we had not done before. I have no similar
  13     evidential statistical information to give about the
  14     public expression, but I have a lot of anecdotal
  15     evidence from patients and from managers and from
  16     executive directors within the Health Service, people
  17     who are not medical, that this guidance is reflecting
  18     things that they want to see in a doctor, particularly
  19     the matters to do with communications and
  20     relationships.
  21   Q. You have anticipated, I think, the questions that I was
  22     going to address to you. If, indeed, this guidance were
  23     purely reflective of the existing views of the
  24     profession, the broad consensus views of the profession,
  25     there would be no significant point, apart from the few

   1     who did not share in that consensus, in putting it down
   2     in writing, except for consumption by the general
   3     public, by those who were not doctors.
   4        What you are saying, as I understand it, is that
   5     that is part and parcel of the publication, to inform
   6     the general public, but also you are saying that there
   7     is an extent to which the standards lead rather than
   8     reflect.
   9        Have I got it right?
  10   A. Yes, that is absolutely correct, and we are already
  11     planning the edition of Good Medical Practice. This is
  12     a refining process, and we are exploring actively how we
  13     can engage the public even further in this process,
  14     because we want the standards and values set out here;
  15     we want the public and the profession to come as close
  16     together as possible on their mutual understanding on
  17     what the qualities of a good doctor are.
  18   Q. Given what we see in paragraph 7 on the right-hand side,
  19     that audit is new in 1998 compared to 1995, you say this
  20     is a development. The second bullet point is
  21     leadership, in other words, it does not enjoy the status
  22     of reflecting existing opinion as much as leading it.
  23     Would a statement in terms of paragraph 7 probably, in
  24     your view, have been acceptable in the 1995
  25     publication -- acceptable to the profession?

   1   A. I think opinion had moved on in that time, but I think,
   2     also, that if we take the second bullet point in
   3     particular, it is less to do with what opinion was about
   4     than what it is actually necessary to do to achieve the
   5     kind of preventive measures that we are describing. You
   6     cannot detach the advice here, the guidance here, from
   7     the other broader policy development than I am
   8     describing.
   9        If I can just perhaps clarify that: whilst this
  10     guidance was being written, between 1995 and 1998, we
  11     had conducted extensive discussions outside in the
  12     course of implementing or preparing for the
  13     implementation of performance procedures across the
  14     country, with Managers in the health service, Chief
  15     Executives, Chairmen, doctors, patients, patients'
  16     organisations, and had gathered a far better
  17     understanding of the problems inherent in developing
  18     ways and means of making sure that doctors not only
  19     understood that they needed to keep themselves up to
  20     date, but how you would actually demonstrate that. An
  21     appraisal was one method, one instrument, which is
  22     widely used outside of medicine but not inside medicine,
  23     which seemed to be appropriate.
  24        So this is not sort of divined as it were in vacuo
  25     from the world outside. I just wanted to make that

   1     clear.
   2   Q. Does it follow from the answer you have given me that
   3     the answer to my earlier question is that, no, it would
   4     not have been acceptable to the profession in 1995 to
   5     have the statement we now see as 7 in that form?
   6   A. Yes, I think that is fair, particularly with the "must"
   7     which is there.
   8   Q. It would follow that, working back in time from 1995 to
   9     1992 into the late 1980s and earlier, all the more so
  10     would that be true of those days?
  11   A. Many doctors felt quite ambivalent about audit and what
  12     it means and what their obligations are.
  13   Q. And what you are describing, really, is the
  14     manifestation of a struggle, is it, to convince doubters
  15     in the profession of there being any value in audit as
  16     it is set out here?
  17   A. There were quite genuine differences of opinion based
  18     upon experiences of the value of audit in the
  19     profession, different experiences in different parts of
  20     the profession. Audit able to be taken much further,
  21     much more quickly in some parts of medicine, surgery is
  22     a good example, obstetrics is another example, where
  23     harder-edged standards, clinical standards, against
  24     which to measure were available.
  25        So the notion that it was audit moving forward on

   1     a broad front, as it were, with a level of
   2     sophistication consistent right across the whole of
   3     medicine, is -- medicine is not like that. It just was
   4     not possible to do it in that kind of way.
   5     Psychiatrists, for instance, find great difficulty, much
   6     more difficulty than surgeons do, looking for hard-edged
   7     standards to assess.
   8   Q. So the answer to my question is yes, generally, so far
   9     as medicine is concerned, but not necessarily for
  10     specific disciplines?
  11   A. Yes, that is correct.
  12   MR LANGSTAFF: Sir, on that note, I note the time. Perhaps
  13     we can now have our first break?
  14   THE CHAIRMAN: Yes, shall we adjourn now and reconvene at
  15     1.15? Thank you.
  16   (12.35 pm)
  17            (Adjourned until 1.15 pm)
  18   (1.25 pm)
  19   MR LANGSTAFF: Before we broke for lunch, we were talking
  20     about the change in development in the profession's
  21     attitude to audit. Before the contracts of doctors in
  22     1991 included the requirement that they took part in
  23     then medical audit, was there any form of professional
  24     requirement that doctors should do so?
  25   A. Before 1991?

   1   Q. Yes.
   2   A. Not that I am aware of. There was not in any GMC
   3     guidance.
   4   Q. So far as any guidance given by any Royal College to the
   5     effect that audit was desirable, that would be
   6     a recommendation, a standard, which would lack any
   7     sanction for its breach, would it?
   8   A. Yes. I mean, I think the earliest reference was in the
   9     GMC document in 1993, "Tomorrow's Doctors". I have made
  10     reference to that.
  11   Q. That was looking essentially to the education of
  12     tomorrow's doctors?
  13   A. I am citing it as the fact that it was being introduced
  14     to GMC documents at that stage. I am not aware of it
  15     earlier.
  16   Q. You yourself described in an article which you have
  17     shown us, Quality and Standards in Health Care,
  18     WIT 51/30, how quality and standards related in health
  19     care in the United States and the United Kingdom
  20     historically, up until the date which I think was 1993,
  21     when you and Liam Donaldson wrote that particular
  22     article?
  23   A. This was written in 1991.
  24   Q. Published in 1993?
  25   A. Published in 1993.

   1   Q. So you were here yourself, in 1991, advocating a form of
   2     quality assurance by testing performance against
   3     published standards and altering performance if that
   4     test should show that performance was lacking?
   5   A. That is correct, and it was more than advocating it.
   6     I had had by then considerable involvement and
   7     experience of doing that, with colleagues in general
   8     practice.
   9   Q. You mention on page 31, at the bottom, the story of
  10     Ernest Codman. This is 1910 in America, and Ernest
  11     Codman you tell us pioneered looking at end results?
  12   A. Correct.
  13   Q. A form very similar to clinical audit as we know it
  14     today, is it?
  15   A. Yes. The object was the same.
  16   Q. It looked at outcomes in terms of results and thereby
  17     evaluated the performance. That was the philosophy of
  18     it, was it?
  19   A. He wanted to try and make sure that as far as possible,
  20     he could account for the results of his surgery. He was
  21     unsuccessful in trying to introduce that idea more
  22     widely, as I explained.
  23   Q. What you tell us in the rest of the article is that the
  24     American doctors found that idea contentious and instead
  25     of an end result, quality cycle approach taking on, the

   1     American doctors decided they would insist on a set of
   2     professional standards?
   3   A. Yes.
   4   Q. That was the way in which they sought to ensure quality
   5     of performance?
   6   A. That is correct. That was the start of their engagement
   7     in the development of a framework for looking at
   8     quality.
   9   Q. So what one sees historically, looking back to the 1910s
  10     and 1920s in America, was a resistance amongst the
  11     medical profession there to the idea of any individual
  12     surgeon or unit's performance being evaluated in any
  13     objective way; it was rather left to the professional to
  14     comply with standards which have general acceptance?
  15   A. Yes. I mean, I think the objection, as far as I know --
  16     this is from historical documents, obviously -- was to
  17     the idea of producing personal results, which is what
  18     uniquely Codman did.
  19   Q. Did one have an exactly similar reaction to such ideas
  20     in the 1980s in the UK?
  21   A. There is a long gap between 1912 and 1980 --
  22   Q. It is not the time, it is the reaction I am asking
  23     about.
  24   A. No, I disagree with you, because in the 1980s, by this
  25     time many doctors in the United States, and in Britain,

   1     were engaged, as I was with many colleagues, in this
   2     kind of exploration, and use of these methods. Indeed,
   3     if you -- I cannot find the page, but I refer also to
   4     the early engagement in this country of the confidential
   5     enquiries into maternal mortality and subsequently
   6     perinatal mortality which laid the foundations for
   7     modern ante natal care and much improved safety. That
   8     was enthusiastically taken up and worked on by
   9     obstetricians in this country.
  10        In 1975 my colleagues and I in the north of
  11     England, those involved in teaching practices, were
  12     actively engaged in audit of our own work and the
  13     collective discussion of our results, and by 1985
  14     onwards, we mounted a large study in teaching practices
  15     in the north of England, I think 67 practices involved
  16     in the business of setting standards for common
  17     conditions in childhood, children under the age of 11,
  18     both acute and chronic, and then testing actual practice
  19     against those standards. We learned a huge amount from
  20     those studies, and they are published, about
  21     opportunities but also the limitations of that process,
  22     in particular what went on when doctors were attempting
  23     to work out what was and what was not acceptable
  24     practice.
  25        So that sort of ethos was well-established in part

   1     of general practice at that time.
   2        Lastly, in parallel with that, I was involved in
   3     this from the start, but with many other colleagues,
   4     general practice introduced -- in bringing in vocational
   5     training in the late 1960s and the early 1970s --
   6     a system of explicit standards in the selection of
   7     trainers and their practices for general practice. That
   8     was coupled with the monitoring of those standards, the
   9     periodic review of those standards by peers, and
  10     a decision as to whether to renew or not a trainer's
  11     contract on the basis of results.
  12        So the ethos of external review using explicit
  13     standards was well-established by then. It is that sort
  14     of ethos that, for instance, in Northumberland today, in
  15     the County of Northumberland, enables the Health
  16     Authority and the doctors to work constructively and
  17     collaboratively to ensure good practice and deal with
  18     problems when they arise because it builds on a culture
  19     and ethos of review which was established over 15 to 20
  20     years.
  21        I have to emphasise that point: changes in culture
  22     and behaviour can take some time to establish. But it
  23     would be quite wrong to say that the general reactions
  24     to Codman in 1912 were typical of reactions in the
  25     country.

   1        Outside of general practice, the surgeons, the
   2     CEPOD enquiries which were started by surgeons and by
   3     anaesthetists to examine practice were, to the best of
   4     my knowledge, well received generally by surgeons. Some
   5     surgeons did not agree, of course, but the vast majority
   6     who wanted to do a good job for their patients took part
   7     in that kind of activity.
   8   Q. You took something like the register maintained by the
   9     Society of Cardiothoracic Surgeons. Again, you would
  10     have a collection of data from those surgeons who
  11     submitted the data from their units, which could be
  12     pooled and the results of which no doubt were of use to
  13     clinicians. But one of the features of which we have
  14     heard in this Inquiry so far of the register was that,
  15     at any rate in the early days and to an extent up until
  16     the present, any contributor to the databank was ensured
  17     of anonymity as to surgeons, but also as to units.
  18        The consequence would be that there would be great
  19     difficulty in anyone other than the individual clinician
  20     assessing his or her performance against anybody else's.
  21        To what extent was that a problem, as you see it,
  22     in the development of seeing how individuals were
  23     performing to standard during the 1980s and early 1990s?
  24   A. Well, it was a real problem, and it still is today, as
  25     a leader in the British Medical Journal of last Saturday

   1     demonstrates. It is the difficulty of on the one hand
   2     trying to achieve a level of openness which in my
   3     experience most conscientious doctors want to achieve,
   4     with the real difficulty of being able to find a safe
   5     environment in which to discuss results when it is not
   6     clear actually what those results actually mean.
   7        Much of the discussion about audit and the
   8     introduction of audit in the late 1980s/1990s was how to
   9     handle that difficult problem, because of course, if it
  10     was not capable of resolution -- and it is still an
  11     imperfect world in this sense -- then one of the
  12     difficulties would be to reinforce attendance if
  13     a doctor is not to discuss those issues, and in
  14     particular, to drive underground matters to do with
  15     perhaps marginal rather than very, very obviously
  16     dysfunctional practice.
  17        It is a kind of an illustration of two competing
  18     goods which are in conflict with each other. I think
  19     the only significance of the leader in the BMJ this week
  20     is to indicate that it is still not resolved.
  21   Q. So you have seen this as a gradual process towards the
  22     present degree of openness, have you?
  23   A. Yes. That is absolutely true, but I think it has to be
  24     seen, also, with a rising awareness within the
  25     profession, that performance matters; that how the

   1     individual doctor behaves and whether the doctor is
   2     clinically effective or not has to be much more
   3     explicit, so the question is now less whether that is
   4     a good idea, but rather, what are the best means of
   5     achieving that objective.
   6   Q. Because any measurement of individual or unit
   7     performance must necessarily have a comparator, must it
   8     not?
   9   A. Yes.
  10   Q. And what you have said a couple of answers ago was that
  11     there was concern about making any comparison from
  12     whatever data was available because the data might not
  13     be clear enough or might be open to misinterpretation.
  14     That was the flavour of the answer you were giving?
  15   A. Yes. I think we actually have to separate out two main
  16     elements. There is one about the matter of data and its
  17     validity and reliability and also how you can get it;
  18     but there is also the matter of the instrument against
  19     which you are measuring in the first place, and the
  20     extent to which it is possible to identify elements of
  21     practice where there is no dispute, for instance, as to
  22     the evidence as to what ideally should or should not be
  23     done, those elements of practice where there are
  24     variations in practice yet doctors know that this is
  25     what should be done, and other elements where there

   1     really are many options.
   2        I think we have, as a profession -- it is by no
   3     means peculiar to this country -- begun to dig into this
   4     business of disentangling what really can stand from
   5     what cannot stand. This is the whole basis of a drive
   6     towards evidence-based practice.
   7        I was in Nijmegen only three or four days ago at
   8     the end of last week at a scientific meeting discussing
   9     these matters and the current state of art and this is
  10     still a real problem, although I am bound to say in the
  11     last ten years, compared with where things were in the
  12     late 1980s, huge progress has been made in the
  13     investment of professional effort and government effort
  14     in trying to disentangle these matters.
  15   Q. Given that one has to have data; secondly a means of
  16     interpreting it, the third element of the equation is
  17     the doctor himself who is either going to make use of
  18     the interpretation or supply the information in the
  19     first place.
  20        So far as audit information was concerned in the
  21     1980s, was the importance of the interpretation seen
  22     essentially as educational rather than informative to
  23     the wider public?
  24   A. Yes.
  25   Q. Has it now changed?

   1   A. Yes.
   2   Q. You refer in your statement -- let us look at it; it is
   3     WIT 51/2(c) to "Changing Patient Expectations".
   4        What do you, in your statement, see as the
   5     expectations of the patients?
   6   A. I think the change in expectations has been one of the
   7     major changes in society, as well as in relation to
   8     medicine, that people have -- ordinary people, all of
   9     us, when we become ill, or relatives, are keener to know
  10     what is being done and why to look for effective
  11     explanations, generally to be willing to question the
  12     doctor in a most constructive way. I think this is
  13     a huge development of trend, and it is one of the wider
  14     consumer revolutions, as it were, which is greatly to be
  15     welcomed.
  16   Q. So this does tie in with what I have been asking you
  17     about the availability of information?
  18   A. I am not an expert on this, but generally speaking, the
  19     consumer revolution coming in from the United States as
  20     it has done, has certainly been fuelled to some extent
  21     on the back of availability to information and there is
  22     no doubt from my own experience now that the quantum
  23     leap in the availability of information since any
  24     patient or any citizen can interrogate the database of
  25     medicine through the Internet is accelerating that whole

   1     process, which is why I referred also to the shifting
   2     balance between patient and doctor in the balance of
   3     power and the doctor/patient relationship.
   4        Many doctors find this quite a challenge, but for
   5     every doctor who does, there are at least as many who
   6     see it as a positive benefit and welcome the robust
   7     discussion of matters to do with the diagnosis and
   8     management of a patient's condition. It is a very
   9     important new contributor to quality.
  10   Q. So by "patients' expectations" in that part of your
  11     statement, you are talking about explanations,
  12     information, the ability to have material upon which one
  13     might question the doctor, and such like?
  14   A. I am, but I am also conscious, we are talking about
  15     a trend again of patients being more prepared, more
  16     willing, to ask questions about the individual doctor's
  17     performance, "How likely, doctor...", "How safe will
  18     I be in your hands?"
  19   Q. At page 14, paragraph 59 of your statement, you mention
  20     one of the themes which runs through what you say, which
  21     is the importance of the consultation. You speak from
  22     someone who -- your experience is in general practice?
  23     You are nodding. I say that for the transcript.
  24   A. Yes, I am sorry.
  25   Q. -- where inevitably the consultation is likely to be

   1     a one-to-one, is it?
   2   A. Yes, although team-based care is part and parcel of
   3     general practice.
   4   Q. To what extent, in using the word "professionalism" in
   5     paragraph 59, are you saying, "Well, whatever the
   6     available information may be, the doctor is he who knows
   7     best"?
   8   A. I am not saying that at all. I am saying, in this
   9     paragraph, how vital it is to recognise that for the
  10     patient the quality of the consultation and all that
  11     flows from that in terms of diagnosis and treatment is
  12     immensely dependent on the integrity and the ability of
  13     the doctor to try and get things right. Most decisions
  14     in medicine -- not just general practice -- are still
  15     taken in relative privacy. It is that recognition of
  16     that very fundamental fact that leads us, or has led us
  17     in the GMC, to place such an emphasis on the culture.
  18     You cannot supervise the millions and millions and
  19     millions of independent individual decisions that are
  20     made about, "Is it this treatment rather than that?",
  21     "Is it this pill?", "Do I do this now or at another
  22     time?" et cetera.
  23        So the whole system I am putting here has to be
  24     geared to trying to make sure that doctors get it right
  25     first time as often as possible, and conduct themselves

   1     in a way that patients find helpful and which they
   2     expect. It goes to the very heart of the whole
   3     regulatory question.
   4   Q. I understand knowledge, I understand skills in the
   5     context of the consultation. Plainly the doctor has to
   6     bring both to bear and the expectation of both doctor
   7     and patient will be that the doctor will do his best to
   8     produce the --
   9   A. The best outcome.
  10   Q. The right result, the best outcome?
  11   A. Yes.
  12   Q. Where is there space for integrity? How does integrity
  13     fit into that picture?
  14   A. In the consistency with which the doctor follows and
  15     uses the knowledge and skills that he or she may have in
  16     the willingness to be honest about the limitations of
  17     the doctor's own practice, to refer to others when the
  18     need arises: the things that are to do with putting the
  19     patient's best interests first, which of course, right
  20     at the front is the matter of the patient's safety.
  21     That is a part which is absolutely central to the ethos
  22     of medicine and pre-dates all the various statements
  23     that we have been talking about here.
  24   Q. So is professionalism in essence a commitment to
  25     attempting to produce the best result for the patient

   1     with appropriate knowledge and skill?
   2   A. And attitude.
   3   Q. And approach?
   4   A. And approach. May I just add one point? We have quite
   5     deliberately distinguished between matters of
   6     competence, the knowledge and skill that a doctor may
   7     possess, and the question of performance, by which we
   8     mean the way in which the doctor applies that knowledge
   9     and skill, and attitude, if you like, why our whole
  10     procedures are based upon performance, because what
  11     matters to the patient is what the doctor does with the
  12     knowledge and skill, not whether he happens to have it
  13     or not.
  14   Q. And how he does it?
  15   A. And how he does it. Competence, the possession of the
  16     attributes of knowledge and skill, is subsumed within
  17     the concept of performance, the application of it.
  18   Q. And in each case, what he does and how he does it, is
  19     open, in an ideal system, is it, to review by
  20     measurement against the standards that the patient would
  21     legitimately expect?
  22   A. Yes. I mean, it has been not technically possible until
  23     recent times, really, to do this, but the principle of
  24     external review has nevertheless been there in
  25     medicine. It is there, for instance, in the use of

   1     external assessors in examinations; it has been there in
   2     the practice of many surgeons for many years, to visit
   3     colleagues, to watch them operating. I have had
   4     colleagues, including senior colleagues, visiting me and
   5     watching consulting and vice versa, so the notion of
   6     that type of observation is not new. What is much newer
   7     is the capacity through information technology in
   8     particular to think of instruments for assessment which
   9     just were not feasible before: it is that kind of
  10     exploration we were into in the late 1980s in general
  11     practice.
  12   Q. So as evidence grows through the availability of
  13     information technology, the range of, if I can use the
  14     word, "permissible" decisions and the range of
  15     permissible manners in which a doctor may make those
  16     decisions with a patient, will get less, will it?
  17   A. Almost certainly so. There is a balance to be struck
  18     because the doctor, in any circumstance, has to take
  19     account in making an assessment of the individual
  20     patient and the condition with which the patient is
  21     presenting, but there is no doubt about the fact that
  22     the development of the clinical guideline which is
  23     simply a statement of best practice, produced in a much
  24     more accessible way than was possible with textbooks,
  25     which were also statements of good practice, brings to

   1     the doctor's attention what current practice actually
   2     is. But as any doctor will say, and I think any patient
   3     will say, I hope at the end of the day, taking full
   4     account of best practice through guidelines, the doctor
   5     will, nevertheless, have to exercise some judgment as to
   6     what, at this particular moment with this particular
   7     condition, is right for the patient. What is new, or
   8     relatively new, is the extent to which doctors engage
   9     their patients with that form of decision-making.
  10        I have not practised since 1995, but I used to sit
  11     with a television screen on the desk and we would review
  12     matters together, write a letter and, you know, "Is this
  13     an accurate reflection of what you think?" "Let us look
  14     at the options available for referral to this doctor or
  15     that doctor", et cetera.
  16        So that kind of engagement between doctor and
  17     patient has been developing in the last 10 years or so.
  18     I know you understand my background in general practice,
  19     where much emphasis has been given to that dimension to
  20     the consultation. We are reading a lot of this across
  21     into specialist practice now.
  22   Q. Given the information technology, given the
  23     collaborative approach with the patient that now applies
  24     when it might not have done, what, if anything, is left
  25     of scope for clinical freedom, other than simply the

   1     exercise of a professional evidence-based judgment?
   2   A. That is a very big statement.
   3   Q. I am asking. It is a question not a statement.
   4   A. I think I am perhaps just testing, then, what is left.
   5     The answer at the present time in the present state of
   6     knowledge, is "a huge amount", because actually the more
   7     we learn about developing evidence-based practice, the
   8     more it becomes clear that there are areas of practice
   9     where absolute certainty does not exist. Hence the huge
  10     investment and the development, for instance, of the
  11     National Institute for Clinical Excellence which is all
  12     about trying to bring greater precision, greater
  13     objectivity to these questions.
  14        But the other area which the clinical guideline
  15     does not deal with particularly well is the fact that at
  16     any point in time, a doctor with a patient is having to
  17     make decisions on perhaps imperfect information,
  18     imperfect data about that patient's particular
  19     condition. He or she cannot wait, as a scientist would
  20     wait in a laboratory, for example, to say, "I will not
  21     make a decision until I have a very complete picture".
  22     People and their illnesses are not like that. So
  23     clinical decision-making is still based on making the
  24     best judgment you can on the available evidence to you
  25     at that particular moment.

   1        It carries with it the responsibility on the
   2     doctor, therefore, to have an attitude of mind which is
   3     one of openness and a willingness to revise those
   4     decisions in the light of further information which may
   5     become available.
   6   Q. At WIT 51/111. This is part of Maintaining a Good
   7     Standard of Professional Practice?
   8   A. Yes, Good Medical Practice came first. This coincided
   9     or virtually coincided with the second edition.
  10   Q. At the bottom of the left-hand column, just highlight
  11     that, Good Medical Practice explains, for example, that
  12     every doctor must be professionally competent and
  13     secondly, perform consistently well.
  14        Can you help me with that statement? Where does
  15     one find that in Good Medical Practice, in terms?
  16   A. It is a synthesis really, an encapsulation of the spirit
  17     of good medical practice that doctors must be
  18     professionally competent and from that flows the notion
  19     that the doctor will apply knowledge and skill
  20     consistently, as I said in my answer to you a moment or
  21     two ago.
  22   Q. So consistency becomes here a professional obligation
  23     spelt out as such, whereas one has to derive it from
  24     looking through Good Medical Practice?
  25   A. I think that is fair comment. I will note that myself,

   1     thank you.
   2   Q. In terms of performing consistently well, one is looking
   3     for an objective measure of performance which takes into
   4     account, no doubt, the range of options available to him
   5     which clinical freedom still permits?
   6   A. Yes. You have to see this guidance in its context,
   7     which is saying, in the units, clinical teams within
   8     which doctors practise, with other colleagues, nursing
   9     colleagues, other medical colleagues, et cetera -- this
  10     is setting up the basis of quality assured practice,
  11     another change in the culture of medicine which we think
  12     is fundamental, and so it is setting out as it were the
  13     ground rules for each doctor, "You must conduct yourself
  14     in this kind of way", and then there is the broader
  15     context in which a clinical team ought to be able to
  16     review the individual practice of each member. That is
  17     where it is all about this refining and trying to
  18     clarify, make more explicit, this responsibility for
  19     maintaining consistency at the point where care is
  20     delivered, or as near to that point as possible. The
  21     individual clinician and the team.
  22   Q. I am glad you mentioned the "team", because what I was
  23     going to go on, having asked you about that, to deal
  24     with was the reaction of the GMC and what one can derive
  25     about the culture of doctors at the time, to the failure

   1     of the Private Members Bill in the 1980s, which was
   2     addressing the question of the word "serious", was it
   3     not, when it came to professional misconduct?
   4   A. Yes.
   5   Q. And am I right in thinking that part of the reason why
   6     the bill may well have failed was that the GMC at the
   7     time indicated that it had in mind taking steps to
   8     resolve the problem that the private member appeared to
   9     have identified?
  10   A. Yes.
  11   Q. Did it take, as it happens, some 12 years after that
  12     before the performance procedures were actually
  13     introduced?
  14   A. There was an important step before that, which followed
  15     virtually immediately. We have to go to the change in
  16     guidance in the 1985 Blue Book, page 10, and the
  17     reference there to "explicit clinical standards". That
  18     represented the first development of an explicit
  19     statement of expectation from a doctor, and as
  20     I referred to in an earlier response to you, that finds
  21     its way now into the current guidance. But it was more
  22     than that; it formed the basis against which charges of
  23     serious professional misconduct were framed and accounts
  24     for the substantial rise in the proportion of clinical
  25     cases which appeared before the Professional Conduct

   1     Committee. It makes the matter very explicit.
   2        FMS 4, page 10 --
   3   Q. You are reading the number from the top right-hand
   4     corner, are you?
   5   A. I do not have any numbers on my top right-hand corner.
   6   Q. We will try and identify the number for you.
   7   A. It was in Mr Scott's evidence.
   8   Q. Yes. We are just looking up the reference.
   9   A. It was the 1985 Blue Book, part 2.
  10   Q. WIT 62/145. You may find the reference at page 153.
  11     We are looking at the covering sheet, there. It is the
  12     left-hand page, is it not?
  13   A. Yes. You will see it in the middle there, the
  14     paragraph beginning "The public are entitled to
  15     expect ... This includes ..." It is that paragraph.
  16        That is the first time that kind of explicit
  17     statement occurred. That statement forms the basis, as
  18     I have said, of a "fitness to practise" procedures
  19     action in appropriate cases.
  20   Q. Writing in 1987, which would be two years after that,
  21     I promised I would come back to the quotation from
  22     Marilyn Rosenthal in her book dealing with medical
  23     malpractice. I will read it to you because we do not
  24     have it scanned in.
  25        She says:

   1        "A major issue is also the relationship of the GMC
   2     disciplinary functions to other mechanisms in the
   3     British medical malpractice system with statutory
   4     responsibilities, particularly the family practitioner
   5     committees and the NHS authorities with responsibility
   6     for the hospital doctors and the courts."
   7        Then she says this:
   8        "The GMC is resisting the enlargement of its own
   9     disciplinary responsibilities and would certainly prefer
  10     to let these other mechanisms deal with as much as
  11     possible, particularly the difficult problems of medical
  12     malpractice and maloccurrence. The key point, however,
  13     is that it is the GMC which maintains the register to
  14     practise and the GMC that controls the ultimate
  15     sanctions. The register to practise is maintained by
  16     a professional body, not a public body."
  17        I want to ask you about a suggestion from her
  18     observation that the GMC was resisting enlargement of
  19     its own disciplinary responsibilities and would prefer
  20     to let the other mechanisms, that is the NHS authorities
  21     and the courts, deal particularly with medical
  22     malpractice and maloccurrence.
  23        As an historical snapshot, is it right or wrong?
  24   A. Could you remind me of the date again, please?
  25   Q. 1987. That is when it was published. It may have been

   1     written months before that.
   2   A. I think it was probably an accurate historical snapshot
   3     in the sense that the Council is not itself
   4     a homogeneous entity; it is like any other group of
   5     people. Professor Kennedy will remember this as
   6     a member of the GMC. I think then that the translation
   7     from, as it were, one approach to a different approach
   8     took time, and not everybody agreed overnight that
   9     a different approach was required; it had to be argued
  10     through, and there were, I remember vividly, some very
  11     robust arguments indeed.
  12   Q. So in the late 1980s, the debate was raging; is that
  13     another way of putting it?
  14   A. The debate was raging -- the debate was continuing about
  15     the necessity of that on the one hand, but there was
  16     another altogether different debate, which was about the
  17     question of evidence and what could be done to close the
  18     gap in the system, the GMC's own procedures, to deal
  19     with performance-related matters. I mean, the genesis
  20     of the performance procedures was there then.
  21   Q. Because the nearest that one would have to dealing with
  22     performance would be, if the ill-health procedures could
  23     be stretched far enough, "somebody who performs like
  24     this must be ill"?
  25   A. Yes. I think that we were pretty clear then, as

   1     I recollect it, that there were two quite different
   2     categories of doctors. There is always an overlap in
   3     terms of the way in which they present. Those who
   4     manifestly had a health problem, that might or might not
   5     include matters to do with their clinical practice; and
   6     there was the separate category where you knew there was
   7     a pattern of repeated poor practice, but none of it at
   8     any point, any of those incidents, sufficient that you
   9     could bring the conduct procedures to bear. That was
  10     the genesis of the performance procedures, to alter the
  11     evidential basis upon which one looked at a doctor's
  12     practice away from a single incident to a pattern of
  13     practice over time. The impetus for much of that flowed
  14     obviously from people who were critical of the system,
  15     but obviously inside also, from the many of us who were
  16     involved in the conduct procedures and could see
  17     intimately in the presentation of evidence to us,
  18     "Clearly something must be wrong here", and yet the
  19     point could not be proved.
  20        So it was less to do with, if you like, the
  21     standard of proof than the nature of the evidence. That
  22     is why the new procedures were routed in a different
  23     form of evidence.
  24   Q. The word "serious" remains?
  25   A. Yes.

   1   Q. So what was the object of the criticism in Parliament
   2     remains as a feature of the scheme and only now its
   3     serious deficiency in professional practice?
   4   A. I am not sure that is true. I had discussions with
   5     Mr Spearing myself in my other capacity in the Royal
   6     College of General Practitioners at the time, and as
   7     I recall it, his concerns were about getting serious
   8     clinical practice looked at. I think he was looking for
   9     mechanisms whereby that might be done. I know he was
  10     also concerned about threshold; I do not wish to deny
  11     that in any way.
  12   Q. There are two threshold limitations, are there, to
  13     treating anything as seriously deficient medical
  14     practice? One is the need to have the word "serious"
  15     looked at and defined and applied, whatever it may mean,
  16     and the second is, is it, the standard of proof?
  17   A. Yes, there are two elements.
  18   Q. So if it is more likely than not that a practitioner was
  19     seriously deficient in performance, and it would follow
  20     his patient is at risk, nonetheless, there would be, as
  21     it stands at present, no right for the GMC to apply any
  22     sanction?
  23   A. I think you are touching on an interesting development
  24     which is very much in our minds now. It relates to the
  25     question, so who defines "seriously deficient", because

   1     of course "seriously deficient" could be quite an open
   2     definition if one chose to make it that way.
   3        In the operation of the performance procedures, we
   4     have said publicly, before they started, that at the
   5     beginning of the understanding of what "seriously
   6     deficient performance" actually means in terms of real
   7     patients and real doctors' performance would come
   8     through the examination of the cases, the case law
   9     developed. We undertook -- I made a very specific
  10     public undertaking that we would put into the public
  11     domain as soon as we were able to the results of the
  12     cases and in sufficient detail that the profession and
  13     the public could form their own view as to whether this
  14     seems to be recognisable deficiency of performance and
  15     therefore whether the threshold might be right or not.
  16        This is a quite different way of thinking and of
  17     course this is exactly what we are attempting to do now.
  18        The first three cases of the performance
  19     procedures, the results were published in what some of
  20     my colleagues in the profession thought was breathtaking
  21     detail and clarity. It is only by that that we will
  22     form some kind of consensus view which needs to be
  23     broader than the GMC of what "serious" actually means.
  24   Q. I do not want in these questions to trespass upon what
  25     is properly to be considered in Phase II of the Inquiry,

   1     which is the future. I have little doubt that topics
   2     such as serious deficiencies in professional practice
   3     may be revisited at that stage, but just so that I have
   4     your view at the moment, you used a moment ago the
   5     expression "recognisable deficiency", hoping that the
   6     public could judge for themselves whether there was
   7     a recognisable deficiency.
   8        If, let us suppose, the requirement before
   9     a sanction could be applied, whatever that sanction
  10     might be, was deficiency, which had to be established
  11     beyond a reasonable doubt, that would have to be
  12     a recognisable deficiency, would it not?
  13   A. Yes. I mean, the GMC enquiries are all about a doctor's
  14     fitness to practise, for that doctor to have
  15     unrestricted registration, so the thing that has to be
  16     right; it is a serious matter. I was trying to
  17     disentangle the two elements here: what is serious
  18     deficiency from the standard of proof, the evidence that
  19     might be required to get to that point. Without
  20     trespassing into Stage 2, I was trying to give an
  21     indication of the thinking that was going on in the
  22     early 1990s about the question of "serious" and whether
  23     it had some kind of very fixed meaning or whether it was
  24     capable of broader interpretation. That is the view we
  25     have come to.

   1   Q. Dr Armstrong, when he gave evidence to us from the
   2     British Medical Association, regarded the question of
   3     fitness to be a doctor as a different question from the
   4     question "Can the doctor do the job?" He said that the
   5     question "Can he do the job?" was for the employer to
   6     decide: "Is he fit to be a doctor?" was for the GMC.
   7        Is that distinction a valid one?
   8   A. Yes, in the sense that, as I indicated earlier, the GMC
   9     cannot, and should not, supervise individual doctors at
  10     work. That is an employment responsibility.
  11   Q. What, then, of the question: "Is he competent or
  12     incompetent at what he does as a doctor?" Is that the
  13     same as fitness to be a doctor?
  14   A. It is included within fitness to be a doctor.
  15   Q. So that if one had a doctor who was incompetent in
  16     a number of respects, although otherwise fit, he would
  17     or would not be subject, do you think, to the
  18     professional practice sanctions of the GMC as the word
  19     "serious" is interpreted?
  20   A. I think we are back to the starting point about how
  21     people come into the procedures in the first place and
  22     the reason why the GMC is placing such emphasis on the
  23     whole question of prevention, of raising awareness in
  24     the profession's mind about what duties and
  25     responsibilities are and through things like maintaining

   1     good medical practice, getting it into people's minds,
   2     this would be reinforced through the clinical governance
   3     kind of arrangements, that it is not just an awareness
   4     but actually being able to demonstrate a fitness to
   5     practise is the right way of handling this.
   6        If one makes that kind of approach -- and as you
   7     know, we have taken the decisions to change the basis of
   8     registration so that doctors in future have to be able
   9     to demonstrate on an ongoing basis their fitness to
  10     practise. If they cannot demonstrate that, to be
  11     referred into our procedures where they can be looked
  12     at, then one has really altered the ground rules of the
  13     game very, very significantly indeed and there are
  14     various steps along the way to any question of serious
  15     deficiency. This sort of approach involving every
  16     single doctor who is practising in that demonstration of
  17     good practice, will, if it works as intended, raise
  18     questions which will need to be addressed where the
  19     doctor's practice may be quite short of the threshold,
  20     but where there is a doubt. Enquiry needs to be made
  21     here as to why this doctor does not quite seem to be
  22     meeting what will be the requirements for revalidation,
  23     and then there is a series of steps that would flow from
  24     that.
  25        This seems to us to be the only sensible way of

   1     addressing the inherent weakness of any
   2     complaints-driven system, whether it is the GMC's or
   3     whether it is the NHS's arrangements, and that is
   4     actually of having a systematic on-going demonstration
   5     of fitness to practise.
   6   Q. The last question that I am going to ask you in this
   7     particular area, before I turn to something applied to
   8     it but slightly different, leaving as I will the
   9     unanswered questions for the future to be dealt with at
  10     Phase II of the Inquiry, is this: you mentioned that the
  11     employment consequences differ from the fitness to
  12     practise GMC approach, as Dr Mac Armstrong addressed to
  13     us. Is there a potential problem, has there been any
  14     potential problem, in employers such as Trusts taking
  15     action to restrict or prevent the practice of a doctor
  16     in a particular field, where they think he may be
  17     incompetent, because they understand the GMC is
  18     conducting its own investigation?
  19        Put another way, does the investigation by the GMC
  20     tend to inhibit an employer in taking action?
  21   A. I have heard that said, but I know of no reason why that
  22     should be the case.
  23        I would add to that, there has also been
  24     a perception and in fact the reality is that the GMC
  25     would tend to follow in the situation where an

   1     investigation might be going on locally; nothing would
   2     be done by the GMC until a matter had been resolved one
   3     way or another locally. That practice has been
   4     changed. It may still actually happen, but
   5     nevertheless, we have altered our practice so that the
   6     GMC action can follow at any time that we have been
   7     alerted to the need for an investigation by a complaint.
   8   Q. I am not sure that in your answers thus far you have
   9     dealt with the application of the appropriate test which
  10     is beyond reasonable doubt for both practice as
  11     I understand it and conduct.
  12        To what extent would you seek to justify a "beyond
  13     reasonable doubt" test of either conduct or competence,
  14     rather than an on balance test, bearing in mind that the
  15     object, at least so far as practise is concerned, is the
  16     protection of the public?
  17   A. The protection of the public is paramount. If the test
  18     as presently applied were shown to be of putting people
  19     at risk, then we would be the first to want to
  20     re-examine that.
  21        This is slightly anticipating, but it helps the
  22     question: we are actually, as part of our major review
  23     of the practises and procedures of fitness to practise
  24     which I initiated in 1995 -- it is a long way down the
  25     line now, but we are looking beyond that to some of the

   1     more fundamental questions underpinning fitness to
   2     practise which has to do with issues to do with the
   3     threshold, the test of evidence, et cetera, but we do
   4     not want to take that in isolation; it has to be part
   5     and parcel of a wider examination, and it has to be part
   6     and parcel of all the other pieces of the puzzle which
   7     are coming together and which I have been describing.
   8        I should add, by the way, just in relation to the
   9     fitness to practise arrangements, you asked me if
  10     I agreed with you this morning that they were
  11     essentially punitive, and I said yes, and I do not
  12     actually agree with that. There is a punitive element
  13     to them, but of course they are primarily about
  14     maintaining the public interest and the safety of
  15     patients. I am sure you know that from the various
  16     matters that have been published. I would not like to
  17     leave you with that wrong impression.
  18   Q. I did not tell you I was finishing all the questioning
  19     altogether, because I am going to turn to another area,
  20     but whilst we are talking about the "reasonable doubt"
  21     approach, did the existence of that as a standard in
  22     effect mean that any case that came before a scrutineer
  23     without any corroboration, just an uncorroborated
  24     complaint, would tend to get dismissed at the scrutiny
  25     stage, or not?

   1   A. No. You mean at the initial scrutiny stage?
   2   Q. Yes.
   3   A. One would look for evidence of the bona fides of the
   4     complaint. We actually apply strict tests which we have
   5     altered recently, to make it easier for complainants,
   6     with access to the procedures that has been too
   7     unfriendly and too difficult for many people to get
   8     through. We have spent a lot of time recently looking
   9     at how, when a complaint is made to us, we can help
  10     a complainant clarify, refine, explain, exactly what the
  11     problem seems to be.
  12        We have also changed our practice in the sense
  13     that if a complaint is clearly not within or appears not
  14     to be within our purview of trying to be helpful with
  15     complainants, so if it is more appropriately dealt with
  16     by another authority -- it might be by the employer, for
  17     instance, or it might a matter of taking something to
  18     law -- that we help people as best as possible to find
  19     the way forward. We entirely accept that our practice
  20     has been less than helpful in that respect in the past
  21     and we and our staff are very keen to make that work
  22     right.
  23        I think the other point, before you leave it, it
  24     was my perhaps less than full answer to your question
  25     about employers. In terms of employers referring cases

   1     into the GMC, and their understanding of whether it
   2     might be easy or not, we have become much clearer in the
   3     course of introducing the performance procedures how
   4     difficult it may appear, or the extent to which
   5     employers may not know what the basis of essentially
   6     good medical practice might be, and that lies behind the
   7     extensive consultation we have done with employers, and
   8     we are doing this with the private sector now as well as
   9     the National Health Service to make it as clear and
  10     explicit as possible that the expectation of doctors
  11     whom they may employ is that of the standards of good
  12     medical practice, the broad standards of good medical
  13     practice, and that default from these in any or some
  14     respects, if they cannot handle it themselves, ought,
  15     automatically, to be a trigger to the GMC.
  16        I cannot understate the importance of this. Huge
  17     numbers of Chairmen and Chief Executives have been quite
  18     unaware of that, and I still find that today. Hence our
  19     engagement in this kind of proactive attempt to make
  20     sure that this basis of professional practice is
  21     understood by employers as well as doctors.
  22   Q. So was it one of the problems in bringing the bad doctor
  23     to book that the non-medical management did not
  24     necessarily know what to expect of a good doctor?
  25   A. Yes.

   1   Q. That would be, would it, a consequence of the fact that
   2     standards and expectations were implicit rather than
   3     explicit?
   4   A. Yes.
   5   Q. So that if you were a doctor, you knew what was expected
   6     of a doctor, but if you were not, you did not?
   7   A. I think that applies to both doctors -- inherent in
   8     implicit standards, that there is a commonality of view
   9     which we know is not always achievable with implicit
  10     standards. It is only when you make things explicit,
  11     there are no grounds for argument about what we are
  12     talking about, that the matter becomes absolutely clear.
  13        That is why we made the duties of a doctor
  14     explicit, not leaving it implicit so that in doctors'
  15     minds there was no room for doubt about what the GMC
  16     meant. That is why we are saying to employers now,
  17     equally, "There should be no doubt in your mind about
  18     those people whom you employ. These, as far as we the
  19     licensing body are concerned, are the particular
  20     standards that we expect. Your job is to monitor this.
  21     You are the people who are employing the doctor, we are
  22     not, and it is not part of our statutory duty to do that
  23     monitoring". We are increasingly making that explicit
  24     and looking for evidence that there are arrangements
  25     there in place for that appropriate monitoring. Of

   1     course, as we are finding, the government through the
   2     Health Service are looking in exactly the same way for
   3