Kieran Walshe
THE DYNAMICS OF REGULATORY REFORM: A CASE STUDY FROM THE UNITED KINGDOM
The arrangements for health professions regulation in the United Kingdom have been the subject of almost constant but incremental reform over the last two decades, and the broad direction of change has been much in line with the trends already outlined earlier in this chapter—extending the reach, scope and intensity of regulation;
changing governance arrangements to diminish the power of the professions themselves and to give greater power to other stakeholders including employers, academic institutions, government and the public;
and harmonising regulatory arrangements across the health professions.
However, progress has often been painfully slow and has been made in the face of covert and sometimes overt opposition from some professional groups (Walshe and Benson 2005).
The health professions in the United Kingdom are currently regulated by nine separate councils (for doctors, dentists, nurses, opticians, pharmacists, osteopaths, chiropractors, and other health professions).
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161 For reasons of history, there are two separate pharmaceutical regulators (one just covering Northern Ireland and the other the rest of the United Kingdom). The Health Professions Council began life regulating a range of professions allied to medicine, like therapists and medical laboratory scientists, and has become the default regulator for any new professions as government has not wanted to create any new separate councils.
Each regulatory body has its own legislation, and the arrangements for undertaking the main regulatory functions set out at the start of this chapter vary to major or minor degrees from regulator to regulator.
They have different terminology, fitness to practise rules, sanctions, governance arrangements, and so on.
It would be impossible to provide an account of recent changes in health professions regulation in the United Kingdom without first explaining the importance of the Bristol and Shipman inquiries—two independent investigations into major failures of care in the British National Health Service (NHS), which produced reports containing recommendations for health professions regulatory reform.
The Bristol inquiry examined poor standards of practice in paediatric cardiac surgery at the Bristol Royal Infirmary in south-west England between 1985 and 1995, which resulted in about 35 avoidable deaths (Kennedy 2001). It concluded that there was a ‘club culture’ among doctors which caused them to put their own professional loyalties and relationships before the safety of patients. It made almost 200 detailed recommendations, but its key recommendation in relation to regulation was that a new statutory body should be created to oversee the nine health professions regulators. The Council for Healthcare Regulatory Excellence was established in 2003 and given legal powers to monitor the performance of the regulatory bodies, to support improvement and coordination, and to review their fitness to practise decisions and appeal those which it found unduly lenient. Over the last five years, it has been an important advocate for reform, and has held the regulatory bodies to account. The then president of the General Medical Council (GMC), Donald Irvine, was a reformer who used the Bristol case to drive a series of changes aimed at making the GMC more open and accountable, and creating a system for revalidation or recertification. His reforms were opposed by much of the medical establishment, which tried to have him unseated (Irvine 2003). When his term as president finished, his successor diluted and delayed his reforms.
The Shipman inquiry examined the case of a GP in east Manchester who, over a period of two decades, deliberately killed about 215 mostly elderly, female patients with injections of morphine. The inquiry remit
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was broad, and it explored the workings of the General Medical Council, its fitness to practise procedures and its proposed approach to revalida-tion. It was highly critical of the GMC, its unwillingness to reform itself and its fitness for purpose as a regulator, and called for a whole series of reforms (Smith 2004). In response, the government commissioned two reviews—one, led by the Chief Medical Officer, of medical regulation;
and one, led by the NHS director of human resources, of non-medical regulation. Those reviews and the resulting reports (Donaldson 2006;
Foster 2006) resulted in turn in a White Paper which has led to the most fundamental and radical changes to health professions regulation to date (Department of Health 2007).
The current changes—still underway as the necessary legislation only passed into law in 2008—involve reform to the governance of all the health professions regulators, to move from elected and professionally dominated boards to appointed boards with representatives of a number of stakeholders. They also modernise and harmonise fitness to practise procedures and sanctions, introduce independent adjudication on those cases, and require all health professions to adopt a form of periodic revalidation. For doctors, they introduce a new local GMC adviser in each health care organisation, which should make the local handling of complaints and concerns much more effective and create better links to employers. They further strengthen the powers of oversight and intervention of the Council for Healthcare Regulatory Excellence. There are some weaknesses—the changes have been enacted using the existing mosaic of legislation (in which each regulatory body has its own Act of Parliament) when it would have been clearer and simpler to replace the existing legislative complexity with a single Health Professions Regulation Act. Moreover, government decided not to move to the use of competence-based regulation and explicit scopes of practice, which would have simplified the processes of harmonising and standardising regulatory arrangements and would have made future changes easier to introduce. Nevertheless, these reforms are more comprehensive and far reaching than any previous changes, and they have been met with little or no professional opposition and have been supported by key opinion leaders like the medical Royal Colleges.
CONCLUSION
Health professions regulation serves both the public and the professional interest, but over the last two decades there has been an international
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163 trend away from regulatory arrangements focused on the economic and social interests of doctors, nurses and other professionals and towards arrangements which give primacy to public protection and patient safety.
These are not simple or straightforward reforms to enact in political terms, because the health professions have powerful vested interests and close links to the establishment and government. The progress that has been made is testament to two key forces. The first is a change in societal attitudes and expectations, in which deference to professional authority and asymmetry in knowledge and education have been replaced by the assertion of individual and collective rights for users and communities by an increasingly well-informed and confident public. The second is the accumulation of evidence from a range of sources, particularly the inquiries into high-profile failures in health care organisations, that patients were being harmed by some health care professionals who should have been stopped from practising, but were not.
The regulatory arrangements now (or soon to be) in place in the United Kingdom are intended to offer an effective modernisation of the regulatory process to make it fit for purpose in a modern health service, while retaining the strengths of the professional philosophy and altruistic motivations which have served health professionals and the public well. Today’s challenge is finding a way to square that circle, and to develop a new contract between the health professions, society and government which is mutually accepted and supported.
One main area of concern remains, which was alluded to in the introduction to this chapter, and was illustrated by the example case of a patient death caused by the incorrect administration of vincristine described in Box 7.1. It is that health professions regulation, despite being perhaps the longest established mechanism for assuring patient safety and service quality in health care, remains largely disconnected from this more recent and wider movement. Indeed, the systems-focused philosophy of the advocates of safety science tends to play down the importance of individual action, motivation and contribution, and to see all or most errors as products of the system or organisation of care.
But it is a mistake not to recognise the importance of individual health professionals in the system of care, or to underestimate the emphasis placed on individual responsibility and accountability in the clinical culture. More integrated approaches to assuring safety and quality are needed, which can connect the systems for measuring and assessing quality in organisations and for individual health professionals, at both the local and national levels.
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