The Pharmaceutical Journal
Vol 268 No 7182 pp117-118
26 January 2002

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"The Society's modernisation programme" articles

In the second of a series of articles on the Royal Pharmaceutical Society's modernisation programme, Christine Gray, project manager. examines the external policy context for the programme, seeking to explain why the programme was established and to explore some of the factors that could influence change

General principles

Legislation

Lay appointments

Next steps

External factors influencing change

The decisions and actions of the regulated professions affect the quality of life for many, sometimes literally making the difference between life and death. The quality of decision-making within the regulatory bodies is therefore a matter of strong public concern. This concern has been intensified in recent years by societal trends such as a less deferential public, more willing to challenge and question the decisions of professionals, together with some high profile cases that have brought health regulators into the spotlight. Most notable among these cases is that which led to the inquiry into paediatric cardiac surgery at Bristol Royal Infirmary where the competence of senior health care professionals was criticised.¹ The report of this inquiry (the Kennedy report) made a number of recommendations on professional self-regulation, and these have strongly influenced government thinking. Last week, the Government published its full response to the Kennedy report.²

The Merrison committee reported on regulation of the medical profession in 1975.³ The committee commented that "the regulation of the profession can be looked upon as a contract made between the public and the profession" and went on to say that "the legislature — that is, Parliament — acts in this context for the public and it is for Parliament to decide the nature of the contract and the way it is to be executed". The committee warned that self-regulation should be "sufficiently efficient and flexible to take account of rapid continuing progress in science and technology, the changing use of medical resources and movements in attitude and outlook of the public and profession alike".

The National Consumer Council, reporting on self-regulation of health professionals in 1999⁴ stated that public interest and safety should be the paramount concerns of regulators and that consumers and lay people should be represented on regulatory bodies. The NCC noted the government's statement in 1998 that; "the challenge for the professions is to demonstrate that professional self-regulation can continue to enjoy public confidence".⁵

In the NHS plan for England,⁶ the Government set out its minimum requirements for health care self-regulatory bodies. The plan states that they must: be smaller, with much greater patient and public representation in their membership; have faster, more transparent procedures, and develop meaningful accountability to the public and health service.

The NHS plan also foretold the Council for the Regulation of Healthcare Professionals (CRHP), now set out in the NHS Reform and Health Care Professions Bill. The Government proposes that the CRHP should, with statutory backing, build a new approach to professional self-regulation. The priorities for this new framework will be to

• Explicitly put patients' interests first

• Be open and transparent and allow for robust public scrutiny

• Ensure that the regulatory bodies act in a more consistent manner

• Provide for greater integration and co-ordination between the regulatory bodies and the sharing of good practice and information

• Require the regulatory bodies to conform to principles of good regulation

• Promote continuous improvement through the setting of new performance targets and monitoring.

The detail of the CRHP's functions and powers remains unclear at this stage. However, the NHS plan made it clear that, were concerns to remain about the individual bodies, the CRHP's role could evolve. Hence, the degree of consistency between the self-regulatory bodies is likely to come into sharp focus.

A recent study of lay involvement in professional regulation⁷ concluded that aspects of policy and practice were likely to come under a hostile spotlight as expectations of lay contributions to the policy process rise. It is also worth noting the report's comments on the regulatory bodies that: "A framework first conceived 150 years ago, having had limited opportunities for development and change, is inevitably creaking under the pressure of operating in a new climate not to mention a much more complex context of care delivery".

In January 2001, the Government stated that it: "continues to believe that self-regulation makes an essential contribution to maintaining and raising standards. But regulation has to be responsive to patients and public, transparent and accountable. We also want to see a co-ordinated approach to the modernisation of regulation across the health care professions".⁸

In the face of these pressures, primarily from Government but reflecting wider public concerns, all regulators in the health field, save those most recently created for osteopaths and chiropractors, have begun to consider how they might reform their structures and processes. Additional forces for change are the evolving nature of pharmaceutical responsibilities, which are moving towards a more direct responsibility to patients, and the widening scope of pharmacy practice.

A sense of urgency has been created for the Royal Pharmaceutical Society to act on professional self-regulation by the position pharmacy has been accorded in the NHS plan. Pharmacists are crucial players in many of the proposed reforms. This requires the profession to develop its own agenda for change and to ensure that the structures and priorities it proposes to pursue are in keeping with the standards practised in other health professions and do not conflict with the national policy agenda.

General principles

Reform of the structures and functions of the various bodies involved in regulation should increase the consistency of approach between the health professions and take account of future oversight by the CRHP. The current proposed changes in legislation for the professions have some common objectives:

• Widening powers to deal effectively with individuals who present unacceptable risks to patients

• Creating smaller councils, comprising both professionals and a strong lay input

• Making explicit the powers of councils to link registration with evidence of continuing professional development (CPD)

• Expediting the procedures for dealing with complaints made against professionals

It seems that, within Government, statutory regulation is increasingly seen as a mechanism that can be used to address the management, accountability and quality of public services and therefore the process is likely to be expanded to a wider range of groupings. Within business and public services the number of statutory regulatory bodies is increasing, indicating a widespread recognition of the need for public accountability. In addition, the professions themselves perceive self-regulation as a means by which some aspects of professional practice can be preserved and protected.

At present, Britain has eight statutory regulatory bodies for health professionals — those for doctors, dentists, pharmacists, opticians, osteopaths and chiropractors, the United Kingdom Central Council for Nursing, Midwifery and Health Visiting and the Council for Professions Supplementary to Medicine, which represents a group of 12 professions. The General Chiropractic Council and the General Osteopathic Council are both new councils and are not as actively involved in the current Government initiative to reform self-regulation in the health professions.

In "Supporting doctors, protecting patients",⁹ the Government stated that two broad functions of professional self-regulation could be defined: (a) determining which individuals should enter and remain members of a health profession at different levels and in different fields of practice; and (b) through (a), supporting health organisations in achieving high standards of quality through clinical governance at local level and through other structures and processes at national level.

It also set out that: "the primary purpose of professional self-regulation is to protect the public. It should be a process through which designated professional bodies provide an assurance that individual practitioners are fit to practise in their chosen field".

In the current political and socio-economic environment, standards of practice have assumed a wider importance, so much so that the professions' interests in self-regulation no longer dominate the scene. As well as the obvious interests of patients and the public, almost all professions with statutory self-regulation are now graduate professions and the academic institutions providing courses leading to professional qualifications therefore have interests in the fitness of students to hold the award. Similarly the employers of practitioners are interested in their fitness to carry out the professional tasks required.

In recent years all statutory regulated professions have seen a year-on-year increase in the number of "fitness to practise" cases. High profile cases, notably in medicine, have provided an impetus for the current process of change. In particular, the Kennedy report has been influential because the chairman noted that the problems seen in Bristol, such as inadequate communications within and between health professions and with those using health services, could have been found in other parts of the NHS, could still arise in the future, and were not unique to surgical practice.

A priority for all health professions is to strengthen regulation and revalidation through a more effective system for dealing with unsatisfactory practice and through CPD programmes. This requires legislation to facilitate these changes.

Legislation

The existing legislation covering self-regulation for health professionals is seen by both the regulators and Government as being in a number of ways inadequate to meet the needs of modern health services and professions. The limitations of the current legislation include issues such as:

• The facility to deal with different types of "fitness to practise" cases (eg, health, performance, conduct)

• The range of options available to offer more effective public protection and rehabilitation where possible (eg, interim suspension from a register or specified conditions of practice)

• The revalidation of professional registration and support for CPD programmes.

The governing council of each of the regulatory bodies has a defined membership, generally made up of a combination of elected and nominated members from the profession, plus a few lay members appointed by the Privy Council and ex officio appointed members.

Registration has tended to be perceived as a once-and-for-all process as long as an annual registration fee is paid and no serious professional misconduct has been found. Although questions of revalidation have been raised with increasing frequency, these could not be addressed within the existing legislation.

Various proposals have now been put forward by the Government to reform the NHS and these build on the vital importance of an appropriately educated and regulated workforce. Developing and introducing new legislation is a lengthy procedure but, through the Health Act 1999, it is now possible to amend existing legislation through Orders in Council (Section 60 Orders), where proposed changes do not involve fundamental change in roles or responsibilities.¹⁰ These orders, which are one of several ways of achieving change, can give the power, subject to Parliamentary approval, to change existing legislation without the need to go through the full parliamentary procedures required for a new Act of Parliament.

Lay appointments

One of the priorities of the NHS plan and Government proposals to modernise professional self-regulation is to increase lay involvement in all the regulatory bodies. While they all currently have lay members, the numbers involved to date have been small. The general view across the existing proposals for change is that the number of lay members on councils should be increased to a level that is almost equal to the professional membership. These lay members should be involved in the total work of the council and particularly in committees considering fitness to practise. The process of their appointment should adhere to the principles set down by the Nolan committee in its first report on standards in public life.¹¹

Next steps

"Learning from Bristol", the Government's response to the Kennedy report, reiterates several of the themes set out in earlier Government documents. These include the intention to "replace the current fragmented arrangements [for the regulation of health professions] with a modern framework that puts the patient at the heart of the process and gives the public greater safeguards". These themes, together with the changes already proposed for a number of the health professions, provide the context within which the Society's modernisation programme will be taken forward.