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

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.