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Procedural Meeting for Stage 3 and Stage 4 of Phase 2
17 March 2003

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           1                                        Monday, 17th March 2003

           2   (11.00 am)

           3             DAME JANET:  This is the preliminary meeting for

           4   Stages 3 and 4 of Phase 2 of the Inquiry.  I would like to

           5   begin by clarifying the representation and attendance this

           6   morning so that I can identify everybody.  There are many

           7   familiar faces, but some less so.

           8             First on my list I see John Hand for the Co-op

           9   Pharmacy.

          10             MR HAND:  Morning, Madam.

          11             DAME JANET:  Thank you very much, Mr Hand.  I will

          12   be coming back to you a bit later about other matters.

          13             Mr Lissack, not here; Mr Gilroy, yes;

          14   Mr McDermott, yes; Mr Pittaway, yes; Beverly Lang, yes,

          15   there you are; Market Street Practice staff.

          16             Is that Miss or Mrs?

          17             MISS OLDFIELD:  Miss.

          18             DAME JANET:  Thank you very much, Miss Oldfield.

          19             The National Pharmaceutical Association, Mr David

          20   Reissner; Mrs Pope is here for the Greater Manchester

          21   Police, I understand.  Yes, there she is, good.

          22   Mr Brandwood for the Royal Pharmaceutical Society of Great

          23   Britain; Royal College of Nursing, Mr Ian Hargreaves.

          24             MR HARGREAVES:  Morning, Madam.

          25             DAME JANET:  Any other representatives here I have


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           1   not mentioned?

           2             Let me begin by giving you a progress ... there is

           3   somebody.

           4             MR STEARS:  Alan Stears from the Home Office Drugs

           5   Inspectorate.

           6             DAME JANET:  Thank you.

           7             As I was saying, I will give you a progress

           8   update.  The reports for Stages 1 and 2 of Phase 2 are in

           9   preparation at the moment and we are hoping to deliver them

          10   to the Secretaries of State in June with a view to

          11   publication in July.  I must stress that the date of

          12   publication is not a matter for the Inquiry.  It is a matter

          13   for Government and I should add that it can only be done

          14   during the time when the Houses of Parliament are in

          15   session.  If it has not been done by the end of -- I think

          16   it is round about 19th July, it cannot then be done until

          17   Parliament reconvenes in the autumn.

          18             The proposed arrangements for the remainder of the

          19   Inquiry are as follows: I think it is well known now that

          20   Stage 3 will deal with controlled drugs and Stage 4 with the

          21   monitoring of general practitioners.

          22             I thought it might be helpful to representatives

          23   if I set out in rather more detail than has been given in

          24   the list of issues the scope that of each of the two

          25   remaining stages.


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           1             In Stage 3 the Inquiry will consider the existing

           2   statutory framework and the adequacy and shortcomings of the

           3   existing procedures for prescribing, dispensing,

           4   requisitioning by signed order, collecting, delivering,

           5   storing, administering and disposing of controlled drugs in

           6   the community.  We will examine the individual cases in

           7   which Shipman stole drugs from patients or obtained them by

           8   fraud on the Prescriptions Pricing Authority.

           9             In particular, we will examine the requirements of

          10   the keeping of the reports by pharmacies, doctors and

          11   nurses.  We shall consider whether these are adequate and,

          12   if not, how they should be improved so as to provide tighter

          13   controls.  We will look at the arrangements for the

          14   inspection of records, how they work in practice and whether

          15   they should be changed.

          16             We will examine the underlying policy of the Home

          17   Office and the procedures they adopt when exercising their

          18   powers and duties under the Misuse of Drugs Act.  In

          19   particular we will consider the policy governing the

          20   exercise of their power under Section 12 of that Act in

          21   relation to doctors convicted of drugs offences.  This will

          22   be considered not only in relation to the way in which

          23   Shipman was dealt with in 1976 but also the way in which

          24   such similar cases have been handled at various times since

          25   1976 and the way in which they are handled today.


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           1             We will examine the way in which doctors and

           2   pharmacists are monitored by the police.  We will consider

           3   how such monitoring is organised, by whom it is carried out

           4   and what training is given to the personnel involved.  We

           5   will consider the role of the Royal College of Pharmacists

           6   of Great Britain in the monitoring and running of pharmacies

           7   and we will consider the roles of the Prescription Pricing

           8   Authority and the Department of Health in the supervision or

           9   monitoring of the use of controlled drugs.

          10             That is the proposed scope of Stage 3.  If anybody

          11   considers that we have missed out something that we ought to

          12   have included, I would be grateful if they would let the

          13   Inquiry know -- not now, but as soon as possible.

          14             The timetable for Stage 3 is as follows: hearings

          15   will begin on 19th May and will be completed in the week

          16   beginning 30th June.  As before, the usual pattern of

          17   sitting will be Monday, Tuesday, Thursday and Friday but

          18   that is not immutable and representatives must be prepared

          19   to attend on any day of the working week.

          20             The first document disk will be distributed today.

          21   I remind everybody that the material is confidential until

          22   it goes into the public domain, either by production at

          23   a hearing or by posting on the Inquiry website.

          24             Salmon Letters for Stage 3 have already been sent

          25   out.  I do not anticipate there will be any more, although


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           1   that possibility cannot be completely ruled out.  I do

           2   stress that Salmon Letters give notice of potential areas of

           3   criticism.  There has been no pre-judgment of any issue.

           4             The arrangements for television and radio

           5   broadcasting will be the same as before.  That means that if

           6   any witness has any objection to the possibility that their

           7   evidence might be broadcast, they should make an application

           8   to be excused from having their evidence filmed and issued

           9   to the broadcasters.  I would like to receive any such

          10   applications before the hearings begin.  I do not want to

          11   have to disrupt hearings in order to deal with that.

          12             The usual arrangements will prevail for the

          13   calling and questioning of witnesses.  For those who have

          14   not appeared before, the arrangement is this: the Counsel

          15   for the Inquiry calls all the witnesses save for those who

          16   have received a Salmon Letter.  If such a witness and their

          17   representatives wish for the representative to call the

          18   witness to make their initial statement of evidence, that is

          19   permitted.  Please inform Counsel to the Inquiry of any such

          20   arrangement.  I should have mentioned that Mr Melton QC will

          21   be primarily in charge of Stage 3.  Miss Swift will be in

          22   charge of Stage 4.

          23             The timetable and witness list is regrettably not

          24   quite ready; there have been a number of last minute

          25   changes.  However, it will be available well before Easter.


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           1             Seminars will be held on the 11th and 12th of

           2   September this year.  The Inquiry does not propose to issue

           3   a discussion paper.  Proposals for change would be welcomed

           4   by the Inquiry.  Any person or body who wishes to submit

           5   ideas of proposals should do so at any time from now but

           6   should ensure that they reach the Inquiry by 14th July.

           7             I will announce the arrangement in respect of

           8   submissions at a later date.  It is likely these will follow

           9   the earlier practice whereby interested parties put in

          10   written submissions and this is followed by an opportunity

          11   for oral presentation.

          12             I will now take any applications for

          13   representation.  I distinguish between representation and

          14   funding.  I will say a word about funding in a moment.  It

          15   may be there are one or two parties here today who have not

          16   formally been granted representation; that is the right to

          17   appear through a representative.

          18             Please, will anybody who wishes to speak wait

          19   until a microphone is close by or move to one if near at

          20   hand.

          21             Mr Reissner?

          22             MR REISSNER:  Madam Chairman, I make an

          23   application for representation on behalf of the National

          24   Pharmaceutical Association and its members.

          25             DAME JANET:  As you will see from the list of


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           1   issues I just read out, the scope of the Inquiry, we will be

           2   looking into matters which are plainly of interest to the

           3   body you represent and, yes, you may be represented.

           4             MR REISSNER:  Thank you very much.

           5             DAME JANET:  Is there anybody else?

           6             Mr Hand?

           7             MR HAND:  I represent Co-op Healthcare who have

           8   been afforded representation.

           9             DAME JANET:  Do you have a microphone there?

          10             MR HAND:  Yes.

          11             I represent Co-op Healthcare Ltd who have been

          12   accorded representational rights.  I also represent Mayfair

          13   Chemists Hyde Ltd, who have not.  In view of the time

          14   sequence, I wonder if Mayfair Chemists Hyde Ltd could be

          15   afforded representational rights?

          16             DAME JANET:  They traded as Battersbys; is that

          17   right?

          18             MR HAND:  Yes.

          19             DAME JANET:  In Market Street?

          20             MR HAND:  Yes.

          21             DAME JANET:  Yes, and they were taken over by

          22   Co-op Healthcare, so --

          23             JOHN HAND:  They were.

          24             DAME JANET:  -- so it is really predecessors in

          25   title of your existing clients.  You may represent them as


                                             7






           1   well.

           2             MR HAND:  Thank you very much.

           3             DAME JANET:  Mr Brandwood?

           4             MR BRANDWOOD:  I appear for the Royal

           5   Pharmaceutical Society.

           6             DAME JANET:  You must plainly be represented.

           7             MR BRANDWOOD:  Thank you.

           8             DAME JANET:  Mr Stears, yes.  I was, I must

           9   confess, slightly surprised to see the Drugs Inspectorate

          10   were here -- I am sorry, my fault, I should have waited

          11   until you had your microphone -- in a separate capacity

          12   apparently from the Home Office.  Of course the Home Office

          13   are entitled to representation.

          14             Are you seeking separate representation for the

          15   Drugs Inspectorate?

          16             MR MACFARLANE:  Madam, I am the Chief Inspector of

          17   the Home Office Drugs Bank.

          18             DAME JANET:  Are you Mr MacFarlane?

          19             MR MACFARLANE:  My name is MacFarlane, Ma'am.  If

          20   I may, at the moment, say we do not know whether or not we

          21   will be represented legally at the hearing, but either way,

          22   of course, will be here to give evidence.

          23             DAME JANET:  Yes, I had rather assumed that you

          24   would be represented as and when necessary by the Home

          25   Office.


                                             8






           1             MR MACFARLANE:  It is possible, Ma'am, that the

           2   Home Office may engage counsel to represent us.  That has

           3   not been decided.  It will be decided in the light of the

           4   letter that was sent to us last week from the Inquiry

           5   Secretary.

           6             DAME JANET:  Perhaps it would be better if you

           7   clarify what your position is and what application you want

           8   to make and make it in writing.

           9             MR MACFARLANE:  That is absolutely fine, thank you

          10   very much, Ma'am.

          11             DAME JANET:  So far as funding is concerned,

          12   I think it is understood now that I cannot grant funding;

          13   all I can do is make recommendation to the Secretary of

          14   State for Health.  I know there is one application for

          15   funding because I have received a written submission from

          16   Mr Hand.

          17             Mr Hand, are you content that that should be dealt

          18   with in correspondence or do you wish to pursue it now?

          19             MR HAND:  No, I do not wish to pursue it now.  I

          20   had a very helpful conversation with Leading Counsel to the

          21   Inquiry and I am content to stand on the written skeleton.

          22             DAME JANET:  Thank you very much.

          23             Is there anybody else who wants to make funding

          24   application in respect of Stage 3?  Good.

          25             Stage 4: again, for the same reason, I will give


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           1   an indication of the scope of the ground the Inquiry intends

           2   to cover.

           3             Dealing first with Primary Care Trusts, formerly

           4   Health Authorities.  The Inquiry will consider the powers of

           5   a Primary Care Trust to monitor the performance of a general

           6   practitioner working in its area with special reference to

           7   what is required or permitted under the statutory framework.

           8   We shall consider the adequacy of the powers available to

           9   the West Pennine Health Authority and its predecessors in

          10   the years 1977 to 1998 -- that is the period during which

          11   Shipman was practising in Hyde -- to look out for or detect

          12   an aberrant doctor.

          13             In particular, we will consider the nature of the

          14   information available to such bodies at the time of

          15   appointment of a doctor and thereafter.  We will examine the

          16   efforts made by the West Pennine Health Authority and its

          17   predecessors to monitor its GPs during that same period and

          18   will compare those efforts with those being made by other

          19   health authorities in other parts of the country.

          20             We will consider the role of the medical and

          21   pharmaceutical advisers.  We shall examine any changes in

          22   the powers available to Primary Care Trusts since 1998 and

          23   the adequacy of the powers now available.  We shall consider

          24   whether more information is now available than was available

          25   at the time when the West Pennine Health Authority was


                                            10






           1   responsible for Shipman.

           2             We will look at the various methods by which

           3   primary care trusts might monitor a GP, including

           4   a single-handed practitioner, such as by appraisal or

           5   inspection of medical reports or by examining mortality

           6   statistics.

           7             We shall discuss the feasibility of obtaining and

           8   using information relating to a doctor's convictions, any

           9   complaints about him or her and any findings of negligence

          10   or breach of duty.  We shall consider the operation of

          11   disciplinary processes with particular reference to the

          12   receipt and handling of complaints or expressions of concern

          13   submitted by one doctor about another.

          14             Turning now to the powers and functions of the

          15   General Medical Council, the Inquiry will consider the

          16   statutory framework governing the powers and functions of

          17   the GMC.  It will consider the organisational structure with

          18   particular reference to the disciplinary or fitness to

          19   practice functions.  The Inquiry has particular interest in

          20   the way in which the GMC deals with doctors who have

          21   committed drugs offences.  The way in which Shipman was

          22   dealt with in 1976 will be compared with the ways in which

          23   cases of a similar nature have been dealt with in the years

          24   since 1976, and are dealt with today.  Insofar as the GMC

          25   imposes restrictions and conditions of supervision on an


                                            11






           1   offending doctor.

           2             We will examine the nature and extent of such

           3   measures.  The Inquiry is particularly concerned to

           4   establish whether the approach adopted by the GMC to such

           5   cases, especially those where the offending has involved

           6   significant dishonesty within a professional context,

           7   provides adequate protection for patients.

           8             The Inquiry will examine how doctors in other

           9   countries are disciplined for drug-related offences and will

          10   consider how other health professionals are disciplined in

          11   this country.

          12             We will also consider how the GMC responds to

          13   complaints about professional misconduct and expressions of

          14   concern about possible errors or incompetence.  We will

          15   examine the procedures followed, including the sifting of

          16   cases prior to referral to the Professional Conduct

          17   Committee.

          18             We will inquire into the extent to which

          19   information about complaints and their outcome and other

          20   material relevant to the competence of the doctors, such as

          21   findings of negligence and breach of duty, have ever been or

          22   are now disclosed to those with a legitimate interests such

          23   as employers.

          24             The Inquiry will consider the GMC's detailed

          25   proposals for revalidation and, in particular, would wish to


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           1   know how and to what extent adverse information such as

           2   complaints and their outcome and allegations or findings of

           3   the negligence and breach of duty will be considered during

           4   the revalidation process.

           5             In respect of all these issues, the Inquiry will

           6   consider whether changes should be recommended.

           7             Turning now to complaints and expressions of

           8   concern by one doctor in respect of another.  I have already

           9   mentioned that that will be a matter of interest in respect

          10   of Primary Care Trusts but the Inquiry will also consider

          11   the duty of a doctor to raise concerns about misconduct and

          12   mistakes of another doctor and what methods are open to a

          13   doctor whose methods raise such concerns.  These will

          14   include the possibility of making a report to the GMC and

          15   the Local Hospital Trust or Primary Care Trust.

          16             We shall consider whether the profession's

          17   perception of its duty in this regard has changed in recent

          18   years.  These issues will be considered particularly in

          19   connection with the duty of the consultants at Tameside

          20   General Hospital to raise concerns about Shipman's treatment

          21   of Mrs Renate Overton in 1994.

          22             Turning to whistle-blowing, the Inquiry will

          23   examine the problems of whistle-blowing in both the

          24   professional and private context.  In particular we will

          25   examine why those who came to suspect Shipman were unable or


                                            13






           1   unwilling to make their concerns known.  We will consider

           2   what conditions should be created to foster a willingness to

           3   report genuine concerns.

           4             It will be appreciated from what I have said that

           5   there will be some areas of overlap of issues between Stages

           6   3 and 4; for example, in Stage 4 our consideration of the

           7   ability of a Primary Care Trust or a Health Authority to

           8   monitor a GP will include the feasibility of monitoring

           9   usage of controlled drugs.

          10             There will also be some witnesses who have

          11   evidence to give, which is relevant to both stages.  The

          12   intention is such witnesses will only be called once in

          13   Stage 3 and will be asked about those topics of their

          14   evidence which are germane to Stage 4 on the same occasion.

          15             The Inquiry recognises that parties interested

          16   only in Stage 4 may wish to attend on occasions during

          17   Stage 3.  Primarily it will be the responsibility of those

          18   parties to follow the Stage 3 proceedings and to see when

          19   a witness in whom they are interested is going to be called,

          20   however counsel and the Inquiry staff will do their best to

          21   issue advance warnings and give assistance in that regard.

          22             Arrangements: the Stage 4 hearings will start on

          23   14th July and will run initially until 31st July.  That is

          24   a Thursday.  We will be sitting each day of that week; no

          25   break on the Wednesday.  The Stage 4 hearings will reassume


                                            14






           1   on 15th September.  There will be a Council meeting in this

           2   Chamber on Wednesday 8th October, so there will be no

           3   hearing on either 8th or 9th October.  We hope -- and I

           4   stress the word hope -- to take a break, if not for a

           5   holiday, at least for further preparation during the week

           6   commencing 3rd November; in effect, a sort of half term.

           7             At the moment, because the programme timetable has

           8   not be finalised, that cannot be promised and I would not

           9   like anybody to book a holiday on the strength of this

          10   indication.  The position will be clarified as soon as

          11   possible.

          12             Apart from that week, hearings will continue until

          13   the week beginning 15th December.  Whether we will need all

          14   that week or only part of it I cannot at present say.

          15             The first disk of evidence will be distributed by

          16   the end of April.  Salmon Letters should go out in early

          17   June.  I think I can assure everybody it is highly unlikely

          18   there will be any Salmon Letter relating to evidence which

          19   will be heard before the summer break.

          20             The witness timetable is not yet available, as I

          21   have indicated, but it will be announced as soon as possible

          22   and I will announce the arrangements for submissions nearer

          23   the time.

          24             Proposals for change will be considered at

          25   seminars to be held in January next year; these will follow


                                            15






           1   the pattern of the earlier seminars, save there will not

           2   have been a discussion paper.  I anticipate an agenda will

           3   be circulated.  The Inquiry will welcome proposals for

           4   change from any interested personal body.  These can be

           5   submitted at any time from now.  I shall impose a cut-off

           6   date in due course.

           7             Is there any additional application for

           8   representation or funding?  Do you want to make an

           9   application now or do you want to wait to see what happened

          10   happens with the Salmon Letters?

          11             MISS OLDFIELD:  I would ask that the application

          12   is made now subject to your approval, Ma'am.  I also

          13   represent the Market Street staff and we have been informed

          14   they are going to be closely concerned with the

          15   whistle-blowing section.

          16             They have already been interviewed and I suspect

          17   will continue to be interviewed and I would ask that you

          18   recommend funding to be continued to Stage 4.

          19             DAME JANET:  The difficulty about that,

          20   Miss Oldfield, is they have received representation up to

          21   now but not on the basis of attendance every day at the

          22   hearing.  That is alright, is it not?  I considered during

          23   Phase 1, in fact, there were particular considerations

          24   applying to your clients which made it desirable that they

          25   should have legal advice at that stage and that is the


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           1   purpose for which funding was granted then and I think also

           2   it maybe that those instructing you assisted in the

           3   preparation of statements and, of course, the Inquiry funds

           4   that.

           5             At the moment, I cannot say on what basis it would

           6   be appropriate to grant funding for your clients and I am

           7   afraid I must ask you to wait until the position is clearer

           8   before I can give it proper consideration.  However, the

           9   Inquiry does have your clients in mind and, as you know,

          10   Mr Palin is always available for advice if necessary.

          11             MISS OLDFIELD:  I am grateful.

          12             DAME JANET:  That is all I wanted to say.

          13             Miss Swift, have you anything to add?

          14             MISS SWIFT:  No, Madam Chairman.

          15             DAME JANET:  Or Mr Melton?

          16             MR MELTON:  No, Madam Chairman.

          17             DAME JANET:  Does any representative have any

          18   other observation they want to make?

          19             In which case I shall bid you goodbye until

          20   19th May.

          21   (11.35)

          22         (Hearing adjourned until Monday, 19th May, 2003)

          23

          24

          25


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