Regulation and revalidation of doctors
Authors: Mike Pringle
Journal: BMJ (2006)

Aprofound loss of public, and to a lesser extent professional, confidence has cast a dark shadow over medical regulation and the General Medical Council for the past few years. After the Shipman inquiry's fifth report,1 revalidation was suspended pending a review by the chief medical officer, Sir Liam Donaldson. The review, Good Doctors, Safer Patients,2 published last week, will be followed by consultation, but the direction is set. As expected, the review places the protection of patients as paramount, but within an appropriate regulatory framework that is practical, non-punitive, and at the international leading edge.

The intellectual case for two levels of revalidation—relicensure for all doctors to remain on the register and recertification for all on specialist and general practice registers—is compelling. Relicensure will be against national standards and implemented through appraisal, 360 degree feedback, and local processes that include lay input.

However, more than 60 000 doctors in unsupervised practice will also need to gain recertification regularly through their royal college against standards set by that college and approved by the GMC. This is a major improvement on the GMC's 2003 proposals for revalidation based on five appraisals and clinical governance sign-off3—proposals that were scathingly condemned in chapter 26 of the fifth report from the Shipman inquiry.1,4

The challenge will be for the GMC to develop Good Medical Practice5 into workable standards for both relicensure and recertification. The royal colleges face a significant task in building on their original work6 to define and assess all dimensions of care for recertification, including the use of objective testing. This will present both an opportunity and a challenge to all the colleges, but in particular the Royal College of General Practitioners because substantial numbers of general practitioners have never been members or have let their membership lapse.

Key to these proposals for revalidation is the appointment of GMC affiliates in all healthcare organisations (NHS and private). They will be locally respected doctors—trained, funded, and supported for their work—who will, when appropriate, resolve concerns raised by complainants, colleagues, or management about a doctor's practice. GMC affiliates will maintain records that follow doctors as they change employer, and any substantiated but not serious concerns will be recorded in a reserved area of the register. Employers will have an opportunity to understand the histories of doctors they appoint.

The GMC will investigate fewer cases centrally, and, if it decides that there are important issues of patient safety at stake, adjudication will no longer be done by a GMC panel, but by an independent tribunal with legal, lay, and medical members. This separation of responsibilities is overdue and will reassure the public. More contentiously, the standard of proof will fall from “beyond all reasonable doubt” to the civil test of “on the balance of probabilities.” This will need to be accompanied by a recalibration of sanctions to ensure that they are appropriate to the offence.

In terms of the GMC and its governance, Professor Donaldson's major proposal is for the medical majority to continue, but with an appointments procedure rather than elections. This is as recommended by the Shipman inquiry, and it should help to ensure a balanced council that is not unduly influenced by specific external interests. But the profession will need reassurance of the independence and remit of the appointment body.

The report contains, however, some important negatives. Firstly, the use of annual appraisal in the relicensure process will greatly reduce its value as a formative process—to the displeasure of many doctors, especially general practitioners. Secondly, the proposal to move the statutory responsibilities of the GMC's Education Committee for undergraduate education to the Postgraduate Medical Education and Training Board is not well argued in the report. Unless a compelling case can be made, this proposal should be resisted.

This is a groundbreaking report that clarifies that the key purpose of the GMC is to protect patient safety, with revalidation based on clear standards being the mechanism. Public and patients' confidence in the system should be greatly enhanced, and doctors will need to accept the rebalancing of interests that this entails. Self regulation was replaced by professionally led regulation, which is now evolving into partnership regulation.7,8 This partnership includes the professions, the public, the NHS and other employers, and the state. As the partnership settles down, the influence of each partner will need to be set so that none are marginalised and none predominate.

The GMC precipitated a crisis by diluting its proposals for revalidation and then responding intransigently to the fifth Shipman report. It will now be more focused and better able to ensure good medical practice, and its culture must now develop to better meet public expectations. It would be a political disaster if the medical profession were to reject the main thrust of these recommendations, which offer a coherent way forward for public confidence in medical regulation and the GMC.