Dr Gerard Panting assesses proposals for safeguarding patients by revalidation of GPs, changes in performance monitoring, and improvements to complaints procedures

In February 2007, the Government published three documents, which set out proposals for change in regulation and a range of other issues. These are as follows:

  • 'Trust, Assurance and Safety',1 which responds to the Chief Medical Officer's (CMO) review of the GMC and medical regulation2 as well as to the Foster review of all the other health profession regulators3
  • 'Learning from tragedy, keeping patients safe',4 which sets out proposals following the fifth report of the Shipman Inquiry5 and recommendations from the Ayling, Neale, and Kerr/Haslam inquiries,6–8
  • 'Safeguarding Patients',9 which summarises the agenda for change.

These proposed changes will have a significant impact on all doctors practising in the United Kingdom.

Changes to the General Medical Council

In common with the other regulators, the GMC is to become a smaller organisation, with a board-style structure; the members are to be appointed, not elected, and the medical majority is to disappear. All this is to ensure independence and to dispel the notion that professional organisations tend to look after their own.

The GMC is no longer to be responsible for deciding 'fitness to practise' cases.1 It will still receive and investigate complaints, but the task of deciding whether the doctor is guilty of failing to live up to the required standard will fall to a new adjudication body. This body will make its decision on the balance of probabilities and not beyond reasonable doubt—a significant move away from the current standard of proof.1 The initial investigation will remain the job of the GMC, but the Council for Healthcare Regulatory Excellence (CHRE), will have powers to review GMC investigations.

Performance issues will also drop out of the GMC portfolio, and will be handed over to the National Clinical Advisory Service (NCAS), which may also be asked to assess practitioners other than doctors and dentists.1

Meanwhile, the Department of Health is to establish a 'wide-ranging and inclusive national advisory group to inform the development of a national strategy for health covering all health professionals.'1

Revalidation in the health professions

The Government believes revalidation should apply to all healthcare professionals but it will be up to the nine regulators1 to decide how it should apply to their registrants, and as far as GPs are concerned, they will be the first to have a revalidation system up and running. The CMO's proposals to make revalidation a two-part exercise involving relicensure and specialist recertification have been accepted.1 The GMC will be responsible for issuing a licence to practise, which will be renewable every 5 years. Renewal will rely heavily on the annual appraisals taking place during the revalidation period. The appraisal process is to be toughened up, with summative as well as formative elements. For GPs it will be the Royal College of General Practitioners that will be responsible for the recertification procedure, and in setting those standards the College will, in effect, influence the way that appraisals, especially the summative part, are undertaken. However, the PCT retains the role of managing and providing resources for the system.

Specialist recertification will apply to all doctors on specialist registers, including GPs, who will have to demonstrate that they continue to meet the standards applicable to their specialty.

GMC Affiliates

The introduction of GMC Affiliates was one of the innovative ideas in 'Good doctors, safer patients'2 but it is accepted that 'the level of investment needed to establish such a system is significant, and that the practicalities of the approach need to be piloted first to learn the most effective means of delivering the aims of the GMC Affiliate model'.1 The Government is, therefore, to implement a modified version of the concept. Rather than having one affiliate per health authority per NHS trust or PCT, affiliates will be responsible for a larger geographical area, perhaps mirroring strategic health authority boundaries, with similar-sized structures outside England, leading medical regulation support teams. Their role would be to help NHS trusts and PCTs with doctors who are struggling, and to be responsible for quality assurance in the revalidation of doctors (Box 1,).

The modification of the role of the GMC Affiliate as proposed by the CMO means that much of the work originally pencilled in for more locally based Donaldson-style affiliates will now be given to Medical Directors in NHS trusts, and someone in the new role of 'responsible officer' in England's PCTs.

The Government has endorsed the CMO's suggested introduction of a new measure—the 'recorded concern'—to be placed on the doctor's registration by the GMC Affiliate. Initially this will run as a pilot exercise in England only, leaving Scotland, Wales and Northern Ireland to consider what they want to do in the light of English experience.1

Box 1: The role of the GMC Affiliate

The following text, which is reproduced from the White Paper,1 outlines the role of the GMC Affiliate, who will be responsible for:
  • providing advice, support and guidance to local employers, NHS organisations and medical directors (or equivalent roles) on local investigations and action to address concerns about doctors
  • monitoring the investigatory work of healthcare organisations and assuring the quality of those who take part in case management, investigation and decision making at local level
  • in England, leading a regional network of medical directors and their equivalents
  • working with a small team of lay GMC Affiliates who would assist and advise clusters of employers within the region, ensuring that local investigation, disciplinary and regulatory actions are carried out in a way that is independent of any conflicting institutional or professional interests
  • assisting employers, commissioners and medical directors and other relevant individuals and organisations in agreeing, developing and delivering packages of assessment, treatment, rehabilitation, remediation, retraining or supervised practice for doctors who either need assistance in preventing emerging difficulties from becoming regulatory matters, or who need support or rehabilitation to assist a possible return to practice following regulatory intervention, involving the NCAS where appropriate
  • assisting employers and medical directors in identifying individuals outside their organisation who are capable of carrying out independent investigations, by drawing on their regional network, with oversight from the lay Affiliates
  • issuing recorded concerns about doctors, based on local investigations and taking into account the recommendations of the local medical director and the relevant lay Affiliate
  • in England, through proportionate risk-based and random sampling of local relicensing procedures, providing independent assurance that these are fit for purpose
  • through the production of an annual report, ensuring that organisational and individual lessons are learned from local cases and disseminated throughout the healthcare system and between regional networks.
Crown Copyright, extract reproduced with permission from Trust, Assurance and Safety—The Regulation of Health Professionals in the 21st Century. London: The Stationery Office, 2007.

Safeguarding patients

Between them, the Fifth Shipman Inquiry Report,5 and the Ayling,6 Neale,7 and Kerr/Haslam8 inquiry reports contain more than 200 recommendations, spanning primary and secondary care. Viewed together with 'Trust, Assurance and Safety',1 the second report from the Department of Health, 'Safeguarding Patients',9 sets the agenda for a more rigorous environment within the NHS.

Clinical governance

The Government says that more needs to be done to strengthen clinical governance processes, and to ensure that they are embedded in the culture of every NHS organisation, including consideration of how the duty of quality can be strengthened. The CHRE has been commissioned to define standards for local investigations, so that these can be used by professional regulators. In addition, a possible extension of the role of the NCAS to include health professionals other than doctors and dentists has been mooted.1

In primary care, the focus on clinical governance will examine how the accountability of GPs to their PCT can be further strengthened, as proposed in the CMO's review of medical regulation (Good doctors, safer patients2). Proposals include clarifying the right of PCTs to access patient records when needed in the course of an investigation, reviewing the Performers List arrangements, and the introduction of a range of lesser sanctions as an alternative to suspending or removing primary care professionals from the list.9

Complaints and concerns

The Government's intention is to issue a consultation paper with proposals for a new complaints system. It will consult with all stakeholders on the possible development of national standards for handling of complaints in health and social care, and for supporting complaints handlers in general practice by setting up networks for mutual support.9

Maintaining professional boundaries

The boundary transgressions work to be undertaken by the CHRE stems from the Kerr/Haslam and Ayling inquiries. Allegations of serious sexual assault on female patients were not taken seriously, so assaults continued over a prolonged period despite the growing awareness of a problem.

New guidance for healthcare professionals and their regulators will define the boundaries that professionals should maintain between themselves and patients. The aim is to develop guidance for the NHS and other healthcare employers on how to prevent, detect, and investigate boundary violations, and to develop a common approach to educational standards on these issues for adoption into training programmes for professionals.

Sharing information on practitioners

The Government will issue or commission guidance on the content of files kept by healthcare organisations about professionals employed by them and on when this information can be shared with other organisations. The Government is also considering extending the current provision under Section 18 of the Health Act 2006, which places a statutory duty on healthcare organisations to collaborate by sharing information and agreeing appropriate joint action in specific circumstances, such as in cases of drug abuse or diversion of controlled drugs.9

A joint project between the Royal College of General Practitioners and the Government will work on indicators of the quality of services provided in primary care, and will discuss the proposals from the Shipman Inquiry that GPs should be required to disclose all clinical negligence claims to their PCT.9

Other areas for reform

In the third and fourth Shipman Inquiry reports there were recommendations on reform of the coroner system and death certification, and the recording requirements for controlled drugs.5

When will the proposals be implemented?

The Department of Health intends to publish an integrated action plan setting out a timetable for all the steps envisaged in Safeguarding Patients9 and Trust Assurance and Safety—the Regulation of Health Professionals in the 21st Century.1 Some of the proposals, such as the new adjudication body, will require primary legislation—a new Act of Parliament covering the medical or health professions—but many of the others can be dealt with by statutory instruments. A new bill is unlikely to appear before 2008. The medical Royal Colleges cannot rustle up recertification procedures overnight so it is not just the legislative logjam that threatens to delay implementation of these reforms.


  1. Department of Health. Trust, Assurance and Safety—The Regulation of Health Professionals in the 21st Century. London: The Stationery Office, 2007.
  2. Department of Health. Good doctors, safer patients: Proposals to strengthen the system to assure and improve the performance of doctors and to protect the safety of patients. A report by the Chief Medical Officer. London: DH, 2006.
  3. Department of Health. The regulation of the non-medical healthcare professions. A review by the Department of Health. London: DH, 2006.
  4. Her Majesty's Stationery Office. Learning from tragedy, keeping patients safe. Overview of the Government's action programme in response to the recommendations of the Shipman Inquiry. London: The Stationery Office, 2007.
  5. The Shipman Inquiry. www.the-shipman-inquiry.org.uk
  6. Department of Health. Committee of Inquiry. Independent investigation into how the NHS handled investigations about the conduct of Clifford Ayling. London: The Stationery Office, 2004.
  7. Department of Health. Committee of Inquiry. Independent investigation into how the NHS handled investigations about the performance and conduct of Richard Neale. London: The Stationery Office, 2004.
  8. Department of Health. The Kerr/Haslam Inquiry. London: The Stationery Office, 2005.
  9. Department of Health. Safeguarding Patients. The Government's response to the recommendation of the Shipman Inquiry's fifth report and to the recommendations of the Ayling, Neale and Kerr/Haslam Inquiries. London: The Stationery Office, 2007.G