The long awaited Donaldson Report was published on 14 July 2006.  Entitled "Good doctors, safer patients", the Report proposes a number of significant changes to the present regulatory regime for the medical profession.  We summarise the key recommendations and their potential implications.

Devolution to local level

One of the recommendations with the greatest potential impact is the introduction of a structure to extend the processes of medical regulation to the local level, the purpose of which would be to create a stronger interface with existing clinical governance mechanisms within the NHS.  The proposal is that medically qualified GMC affiliates would work at local level together with a member of the public.  They would deal with more minor concerns and refer the more serious cases on to the GMC.

Affiliates could not impose a sanction upon registration but could enter a "recorded concern" about a doctor's practice on the Medical Register, which would also be reported to employers and the GMC.  A national committee would routinely review these recorded concerns and take a view on whether any should be referred on for further assessment or investigation. 

Arrangements to deal with matters locally without the need for full GMC investigation are in principle to be welcomed. However the proposals raise a lot of questions about how exactly the new procedures would work. For example, what kinds of problems would merit a 'recorded concern', how would consistent decisions be made on what merits full GMC investigation, would a national committee simply lead to duplication of effort and introduce yet another regulatory tier etc etc.? The new proposals would place a lot of power in the hands of one doctor and there will have to be checks and balances to ensure fairness and consistency for doctors whose professional conduct falls to be considered at local level. The proposals are also potentially very costly and there must be a question about the cost effectiveness of a new layer of clinical governance to deal with concerns that are not serious enough to impinge on registration nor to be adjudicated on centrally.

The GMC's role in "serious cases"

The Report proposes that the GMC should focus on investigation.  A new independent tribunal would be created to adjudicate on cases, a trend that we see reflected across a number of regulatory regimes.  Also in line with general regulatory development, it is intended that the independent tribunal would apply the civil standard of proof, that is, proof "on the balance of probabilities" as opposed to the higher criminal standard, "beyond reasonable doubt".  This particular issue is discussed in more detail elsewhere in this edition.

Revalidation

It was suggested in the Report that there was a need to introduce an effective and sustainable system of regular assessment in relation to doctors' practice.  This would be required in order to overcome the weaknesses of the earlier revalidation proposals, which were put on hold following their criticism by Dame Janet Smith in the Shipman Inquiry.  The Report therefore proposed new revalidation procedures, combining renewal of a general licence to practise for all doctors, and re-certification of the right to be included on either the specialist or GP register.  In the event that the renewal or re-certification procedures were not satisfied, the doctor would undergo a period of supervised practice or non-practice while a rehabilitation or remediation plan is put in place.

The GMC response

Sir Graeme Catto, President of the GMC, commented on the Report on the day of its publication.  He welcomed some of the more general "aspirations" raised in the Report, such as greater patient and public involvement, better coordination between employers and the GMC, easier access for patients and employers to information about their doctors and better targeting of regulatory resources. 

He was perhaps less enthusiastic about some of the more far-reaching proposals and their potential implications.  He referred to the relatively recent reforms put in place in terms of the GMC structure and fitness to practise procedures, noting that these had not long been introduced and that it was not clear to the GMC that the case for further change had been made, or that the disruption that would be involved was justified.  These arguments are well understood and are likely to find favour in some quarters, especially given the costs involved. 

What next?

The Report raises a lot of questions and will no doubt provoke a lot of debate. The proposals are subject to a consultation process which will close on 10 November 2006.  The full Report is available on the Department of Health website, where an electronic response form is also available for any input you may wish to make to the consultation process.  It will be very interesting to note the nature of the responses from the various interested parties and whether, in time, Sir Liam Donaldson's recommendations come to fruition in their proposed form or otherwise. 

Again, the issues being considered here by the medical profession have obvious parallels with and cross-relevance to the regulatory issues facing other professions, including the appropriate level within (and possibly outwith) a profession at which disciplinary complaints should be considered.

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