Annex A > Chapter 4 - National Accountabilities and Roles > The National Framework: responsibilities for healthcare > Changes since the period of the Inquiry's Terms of Reference
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Changes since the period of the Inquiry's Terms of Reference
73 A number of changes in approach and view since 1995 were highlighted in evidence. Sir Graham Hart told the Inquiry:
`I think these days there is a greater interest at the centre in policy implementation and performance of the NHS than there was originally. That is an area where I think attitudes have changed somewhat, practice has changed somewhat, over the years.' [93]
74 As a result of the Bristol experience and other factors, the DoH [94] and government ministers are now more willing to intervene generally. Sir Alan Langlands thought that:
`... current Ministers have no hesitation about intervening in areas where they feel, rightly in my view, responsible and where they feel they have to act. ... So I think attitudes have been changing over time, and I think that really the point I want to get across here is a sort of evolutionary point: that through all of this, the relationship between the government medical profession and the public has been changing ... issues of public accountability and self-regulation have to be in keeping with the current public mood. They cannot somehow be rooted in the past or in sort of romantic notions of clinical freedom in a bygone age. We are living in a different world.' [95]
75 Examples of where the willingness of the DoH to use its influence has changed UK clinical practice are heart transplants and the Kasai procedure for biliary atresia. Following a departmental press release, No 1999/0268 of 30 April 1999, Counsel to the Inquiry was able to tell the Inquiry that:
`We have heard what has recently happened with the Kasai procedure for biliary atresia, where we are given to understand that the Department has secured as a result of representations made to it that no more than three centres in England should conduct this particular form of procedure, the idea being, as we understand it, that otherwise the numbers of such operations would not be sufficient to ensure that any one team of clinicians had the sufficient expertise, quite apart from the necessary facilities.' [96]
76 Current interest in the supervision of poorly performing doctors by the DoH or its representatives is exemplified by an internal minute of 9 December 1996 from Dr Graham Winyard, Deputy CMO 1993-1998, to all Branch Heads and above in the NHS Executive, which advised staff who became aware of allegations about poorly performing doctors that they should report the matter to the appropriate Regional Director of Public Health. [97] The note adds, however, that:
`Simply notifying the Department of Health does not absolve people from taking local action within their own organisation, and they should be reminded of this.' [98]
77 The introduction of new surgical techniques has, since 1996, been managed under the Safety and Efficacy Register of New Interventional Procedures (SERNIP). Professor Sir Kenneth Calman explained the operation of SERNIP:
`The principal safeguard [for ensuring that the introduction of new surgical techniques is managed safely] - beyond the work of local ethics committees - is the Safety and Efficacy Register of New Interventional Procedures (SERNIP). This voluntary system, which is independent of the Department of Health, was set up under the auspices of the Academy of Medical Royal Colleges in 1996 and continues to receive funding from the Department of Health.
`SERNIP is staffed by a part-time clinical director and a full-time administrator, and is supported by an Advisory Committee whose membership includes 11 representatives of the Medical Royal Colleges, and representatives from the Standing Group on Health Technology, the Medical Research Council and the Medical Devices Agency. The Department of Health has observer status on the Committee.
`A clinician when considering introducing an innovative procedure into his/her clinical practice is encouraged to contact the SERNIP office; alternatively, the enquiry may come from a Trust or commissioner. If the procedure in question is already on the register, the SERNIP office notifies which of four categories it has been assigned to. If it is not on the register, they arrange for an assessment of the intervention by a professional advisory committee, based on the published literature, to assign a category.
`In their current form the four categories are:
- `Safety and efficacy established: procedure may be used
- `Efficacy established. Further evaluation required to confirm safety: procedure can be used as part of a surveillance programme registered with SERNIP
- `Safety and efficacy not proven: should be used only as part of a primary research programme, using appropriate methodology and registered with SERNIP
- `Safety and/or efficacy shown to be unsatisfactory, should not be used.
`The Committee's advice is then notified to the clinician who raised the original enquiry. A summary of SERNIP's recommendations is also circulated to health authorities. SERNIP has so far categorised over 100 operations and procedures.
`If a surgical intervention involves the use of a medical device, the device is subject to statutory regulation under the terms of the two European Directives (a third directive covering in-vitro diagnostics will come into force in June 2000). Essentially, these provide safeguards about the safety and performance of the device, in particular that any risks associated with use of the device are acceptable when weighed against the benefits to patients. The Directives also establish procedures for post-market surveillance and reporting of adverse events. The competent authority in the UK for overseeing the application of the Directives is the Medical Devices Agency (MDA). ...
`The Department of Health and the Academy of Medical Royal Colleges are currently reviewing SERNIP. In particular they are considering the steps needed to ensure the participation of clinicians across all relevant specialties; detailed aspects of the process, including the possible need for a formal "appeals" procedure; and relations to the MDA and the National Institute for Clinical Excellence [NICE].' [99]
78 SERNIP was set up following problems with the introduction of laparoscopic surgery. The May 1994 report `Quality Assurance: The Role of Training, Certification, Audit and Continuing Professional Education in the Maintenance of the Highest Possible Standards of Surgical Practice' of the Senate of The Royal Surgical Colleges of Great Britain and Ireland stated:
`New techniques and procedures that are developed after an individual's training has been completed will be dealt with by the continuing professional education programme (see Section 3). ...
`3. Continuing Professional Education
`The profession believes that new techniques should be dealt with in the following manner:
`a. New techniques must be detected, through literature, communication and conference reviews, when they are first made public.
`b. If a technique is considered by the profession to be sufficiently novel as to require special training and assessment before being introduced into general clinical practice, its initial use should be controlled and limited to a number of specified centres for clinical trial. The Colleges are now devising the mechanisms for achieving such control. ...
`The problem for surgeons will be the definition of what is sufficiently new and different from existing practice to demand such control. Most technical developments are simply minor improvements on an existing technique.' [100]
79 Sir Barry Jackson, President of the Royal College of Surgeons, told the Inquiry:
`If you look in (b) [WIT 0048 0144] it says "the Colleges are now devising the mechanisms for achieving such control". They did this by setting up the Safety and Efficacy Register, New Interventional Procedures, SERNIP for short, which was developed in the 12 months after this document was published. It was actually formalised at the beginning of 1996, and widely publicised amongst purchasers, Trusts, clinicians, specialty associations and such like, whereby new techniques should be referred to this new body, SERNIP, for careful assessment as to whether or not this was a technique that could be recommended to Trusts and purchasers for widespread implementation, or whether it needed further refinement, proper controlled trial assessment, or whether it was found wanting. This body, SERNIP, has now been working for three years and has, by common consent, been reasonably - I say "reasonably" rather than "wholly" - successful in its aims and objectives. Only "reasonably", because it has not always had everything referred to it for assessment. It is a voluntary system of referral, and there have been one or two things that have just not been referred to it, but by and large, it has worked, I think, terribly well and its funding, which is Department of Health funding, has been extended for a further one year pending discussions with the new body, the National Institute of Clinical Excellence, and how it might interrelate with that new special authority, NICE.
`Q. So the mechanism set up in 1996 was SERNIP?
`Q. Prior to SERNIP, would it be the case that the identification of a new technique which raised ethical issues or issues of training would be reliant upon the surgeons concerned and that they might, if they needed advice, be reliant on local ethics committees or research committees to discuss the problems raised by new techniques?
`A. You would be right in that, yes.' [101]
80 SERNIP categorised procedures into four; however, Mr Julian Dussek, President of the Society of Cardiothoracic Surgeons, wrote:
`It [SERNIP] incorporates a method of identifying and registering new international procedures whose safety and efficacy have not been established and advising on how they may be evaluated in a controlled way. ... Unfortunately, admirable as the system is, it does not deal with the actual problem of a surgeon learning a new operative technique.' [102]
81 The expert evidence on the issue of innovation in surgery is set out in Chapter 19 - Statistics Relating to the Clinical Performance of Paediatric Cardiac Surgical Services in Bristol Compared with Other Specialist Centres during the Period 1984 to 1995.
82 In so far as the change in approach described by Sir Graham Hart relates to a greater willingness to be prescriptive about what services may be provided, Professor Sir Kenneth Calman explained that the DoH can prevent, on ethical grounds, a new technique from being introduced: `... government at that level has a fairly strong veto on the kind of things that can and cannot be done'. [103] He cited the example of xenotransplantation.
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Footnotes
[94] T65 p.79 Sir Alan Langlands
[95] T65 p.105 Sir Alan Langlands
[96] T66 p.28 Counsel to the Inquiry
[97] WIT 0335 0043 Sir Alan Langlands. The note `Handling Reports of Service Problems Post Bristol' is at WIT 0335 0193
[98] WIT 0335 0193 Sir Alan Langlands
[99] WIT 0336 0021 - 0023 Professor Sir Kenneth Calman
[100] WIT 0048 0143 - 0145 ; `Quality Assurance: The Role of Training, Certification, Audit and Continuing Professional Education in the Maintenance of the Highest Possible Standards of Surgical Practice'
[101] T28 p.104-6 Sir Barry Jackson
[102] SCS 0003 0002; Dussek, J. `Avoiding the Learning Curve' (13 September 1998)