Reforming regulation of the medical profession: The risks of risk-based approaches

Abstract

Risk-based regulation is growing in popularity and in the UK has official backing as part of the government's modernization programme. State and non-state regulators alike are under pressure to adopt risk-based approaches. With radical reform of the General Medical Council (GMC) in progress, the rhetoric of risk-based regulation is used by both the Department of Health and the GMC, and is evident in the 2007 White Paper Trust, Assurance and Safety—The Regulation of Health Professionals in the 21st Century. This paper focuses on the dilemmas inherent in risk-based approaches to regulation by the GMC. Two sources of difficulty are examined. First, the evidential demands can be heavy and costly. Databases and information sources related to patient safety and the performance of doctors are proliferating, but have important limitations. Second, decisions about which risk factors to include and how to weight them are riddled with difficulties, both technical and normative. One attraction of risk-based approaches is that they seem to offer objectivity, but it is questionable how far this is possible in practice. Risk information is neither generated nor used against a neutral background. In the medical regulation arena, questions of public trust and confidence are crucial: risk-based regulation does not help deal with these. Furthermore, a focus on individual doctors and a certain amount of blame and sanctioning would seem to be integral to regulatory functions of such bodies as the GMC. The paper poses fundamental questions about how blame-free these systems really can be.

Keywords:

• Risk-based regulation
• risk assessment
• medical regulation
• medical profession
• General Medical Council
• patient safety
• better regulation

Notes

1 This section draws from Hutter 2004. See also Hutter 2005.

2 It was originally established as the General Council of Medical Education and Registration of the United Kingdom. At the time, one in three doctors were thought to be practising without qualifications (Walton 1983).

3 Medical (Professional Performance) Act 1995.

4 The English general practitioner (1946 – 2004) who was convicted in 2000 of killing 15 of his patients. The subsequent Inquiry concluded that he probably murdered about 250 of his patients (Smith 2005).

5 Under the National Health Service Reform and Health Care Professions Act 2002 s29.

6 For example, research on impaired fitness to practice, indicators of dysfunction and complaints.

7 The inherent looseness of definition of risk-based regulation and use of terms such as ‘light-touch regulation’ is apparent throughout this debate.

8 Reform of regulation of the medical profession is taking shape whilst regulation of healthcare much more widely has been influenced by Hampton and the popularity of risk-based approaches. See Scrivens (2007).

9 Both sets of data are now stored fully electronically and are interlinked.

10 The example illustrates the further difficulty of regulating where harm may be caused deliberately. Shipman was acting deviously and would in all probability be able to work around many checks and escape suspicion.

11 National Health Services Reform and Health Care Professions Act 2002.