15.There is a statutory framework for the regulation of each of the healthcare professions and for the social care workforce. The Act’s provisions affect the following 12 independent statutory bodies:
General Chiropractic Council
General Dental Council
General Medical Council (‘GMC’)
General Optical Council (‘GOC’)
General Osteopathic Council
Health Professions Council
Nursing and Midwifery Council (‘NMC’)
Pharmaceutical Society of Northern Ireland (‘PSNI’)
Royal Pharmaceutical Society of Great Britain (‘RPSGB’)
General Social Care Council (‘GSCC’)
Care Council for Wales (‘CCW’)
Hearing Aid Council
16.The main purpose of these regulatory bodies is to provide protection for both patients and the public through the execution of their statutory duties. Each regulator’s constitution, functions, and duties are laid out in individual Acts and statutory instruments.
17.In addition, the Council for the Regulation of Health Care Professionals (‘CRHP’) was established by the National Health Service Reform and Health Care Professions Act 2002 (‘the Health Care Professions Act 2002’). Its general functions (as set out in section 25 of that Act) are:
to promote the interests of patients and other members of the public in relation to the performance of the healthcare regulatory bodies, their committees and officers;
to promote best practice in the performance of those functions;
to formulate principles relating to good professional self-regulation, and to encourage regulatory bodies to conform to them; and
to promote co-operation between regulatory bodies, and between them and any other body performing corresponding functions.
18.Prior to the Health Act 1999 it was only possible to make changes to the Acts relating to the healthcare professions by presenting a Bill to Parliament. Section 60 of the Health Act 1999 allows Her Majesty, by Order in Council, to modify the regulation of the existing regulated healthcare professions, and to bring other healthcare professions into statutory regulation. An Order may repeal or revoke an enactment or instrument, amend it, or replace it (subject to the restrictions in paragraphs 7 and 8 of Schedule 3 to the Health Act 1999). The Government must consult on draft Orders prior to laying them before Parliament. The Orders are subject to the affirmative procedure.
19.The regulation of the social care workforce in England and Wales is governed by Part 4 of the Care Standards Act 2000 which established the GSCC and the CCW. The GSCC and the CCW (referred to collectively as ‘the Councils’) regulate the training of social workers, maintain registers of social care workers, and produce codes of good practice for social care workers and for employers of such staff. The purpose of regulation is to establish an independent standard of training, conduct and competence for the social care workforce for the protection of the public and for the guidance of employers, with the goal of improving standards in social care work. New powers in this Act will enable modification of the regulation of the social care workforce. These powers broadly mirror the existing powers in section 60 of the Health Act 1999 which enable modification of the regulation of the healthcare professions.
20.Paragraphs 4.32 to 4.37 of the White Paper “Trust, Assurance and Safety – The Regulation of Health Professionals in the 21st Century” (‘Trust, Assurance and Safety’, published in February 2007) set out the Government’s intention regarding the separation of adjudication of fitness to practise cases from their investigation and prosecution. Part 2 of the Act provides the legislative underpinning for this through the creation of the Office of the Health Professions Adjudicator (‘the OHPA’).
21.Paragraphs 1.8 to 1.14 of Trust, Assurance and Safety set out the Government’s position regarding the independence and composition of the health profession regulatory bodies, particularly the current proportion of lay membership of the councils of these bodies. Recommendations were made that future lay involvement in the work of the regulators should be expanded generally, but specifically that there should, as a minimum, be parity of lay members with professional members and that a lay majority should also be possible if desired. Part 2 of the Act provides the legislative underpinning for this through amendments to the Health Act 1999.
22.Paragraphs 4.3 to 4.13 of Trust, Assurance and Safety set out the inconsistency in respect of the standard of proof used in fitness to practise proceedings by the health profession regulatory bodies. Only two regulators (the GOC and the NMC) still use the criminal standard while all other regulators use the civil standard. The Government recommended that all the regulators should use the civil standard in fitness to practise proceedings and Part 2 of the Act provides for this to be incorporated into legislation through amendments to the Health Act 1999. A similar provision is made to use the civil standard in any proceedings which relate to a social care worker’s suitability to be or remain registered. This ensures consistency between the regulation of health professionals and the social care workforce in this area.
23.The regulation of pharmacy is shared by two bodies, the RPSGB and the PSNI. The RPSGB’s responsibilities cover professional regulation as well as leadership and representation of the profession. It also has an important role regulating and inspecting pharmacy premises and the Government has recently put in place legislation (in England and Wales) to enable it to take on the role of regulating pharmacy technicians. The RPSGB’s responsibilities towards pharmacists for professional leadership are potentially in conflict with its role as an independent regulator for the profession itself. The professions are taking on an increased clinical role in the treatment of patients, whereby pharmacists have the autonomy to prescribe potent drugs. Therefore, this dual responsibility does not provide sufficient reassurance to the public that there is effective independent regulation of this role. Separation of the regulatory system from that of professional and clinical leadership will allow each distinct function to focus solely on its core role.
24.Amendments are required to the Health Act 1999 to allow an Order made under section 60 of that Act to remove the statutory function of pharmacy regulation from the RPSGB and the PSNI and transfer these functions to the proposed General Pharmaceutical Council. This new General Pharmaceutical Council will be responsible for the regulation of pharmacists, pharmacy technicians and pharmacy premises. This approach was set out in paragraphs 1.29 to 1.36 of Trust, Assurance and Safety and supported by the Working Party chaired by Lord Carter of Coles. The statutory powers of the RPSGB and the PSNI (subject to a decision by Northern Ireland Ministers to proceed in this way) would be transferred to the new regulatory body.
25.The Hearing Aid Council was established by the Hearing Aid Council Act 1968. Since 2003 it has been operating as an Executive Non-Departmental Public Body. Its general functions are:
to set requirements for registration and practice as a “dispenser of hearing aids” (as defined in section 14 of the 1968 Act, and referred to elsewhere in these notes as a “private hearing aid dispenser”);
to maintain a register of hearing aid dispensers and of employers of registered hearing aid dispensers;
to maintain standards of practice for dispensers;
to investigate whether standards have been breached by registered dispensers;
to take disciplinary action against dispensers who have breached its regulations/standards.
26.Amendments are required to section 60 of, and Schedule 3 to, the Health Act 1999 to allow for the transfer of the regulation of private hearing aid dispensers, currently regulated by the Hearing Aid Council, to the Health Professions Council. The Government committed, following the Hampton Report(4), to abolishing the Hearing Aid Council by April 2009. The decision was taken to transfer responsibility for the regulation of private hearing aid dispensers to the Health Professions Council. This will reduce the number of regulators but more importantly provide improved protection for the hearing impaired. Part 2 of the Act therefore also contains provision for the dissolution of the Hearing Aid Council following this transfer.
27.Paragraphs 3.35 to 3.39 of Trust, Assurance and Safety set out the Government’s intention for oversight of local elements of revalidation and sharing information on concerns about doctors. Part 2 of the Act provides the legislative underpinning for this through the establishment of the role of the “responsible officer”.
28.By way of overview, Part 2 of the Act contains changes to the regulation of health professions and the health and social care workforce. This is in line with the Government’s response(5) to various inquiries into the actions of specific health professionals(6). Provision is made for:
the creation of a new body, the OHPA, which will have adjudication functions in relation to the professions regulated by the Medical Act 1983 and the Opticians Act 1989;
amendments to Part 3 of the Health Act 1999: extending the powers under section 60 of that Act (including, in relation to pharmacy, measures to facilitate the establishment of a General Pharmaceutical Council; measures to allow the transfer of the regulation of private hearing aid dispensers from the Hearing Aid Council to the Health Professions Council; and the removal of the restriction that currently prevents there being a lay majority on the councils of the regulatory bodies); imposing the use of the civil standard of proof by healthcare professions regulators in proceedings relating to fitness to practise;
the renaming of the CRHP as the Council for Healthcare Regulatory Excellence, and amendments to its constitution and functions and the way members are appointed;
regulations to require designated bodies in the United Kingdom to nominate or appoint “responsible officers” who will have responsibilities relating to the regulation of doctors. Designated bodies will be bodies that provide, or arrange for the provision of, health care or employ, or contract with, doctors;
the extension of the role of responsible officers in England and Wales and Northern Ireland to clinical governance issues, in particular the monitoring of conduct and performance of doctors, through regulations;
the creation of a general responsibility on healthcare organisations, and other specified bodies in England and Wales, to share information regarding concerns about the conduct and performance of healthcare workers, and to agree the actions needed to protect patients and the public;
the abolition of the Hearing Aid Council on the basis of the transfer of responsibility for the regulation of private hearing aid dispensers to the Health Professions Council;
a regulation-making power to enable modification of the legislation governing regulation of social care workers in England and Wales; and requiring the application of the civil standard of proof in proceedings concerning the suitability of a social care worker to be or remain registered in England or Wales;
a regulation making power to enable modification of the functions of the GSCC and the CCW in relation to the education and training of approved mental health professionals (‘AMHPs’).
Reducing administrative burdens: effective inspection and enforcement, published March 2005.
A White Paper: Trust, Assurance and Safety - the Regulation of Health Professionals in the 21st Century, published February 2007;
Safeguarding Patients – the Government’s response to the Shipman Inquiry’s fifth report and the recommendations of the Ayling, Neale and Kerr/Haslam Inquiries; and
Learning from tragedy, keeping patients safe: Overview of the Government’s action programme in response to the recommendations of the Shipman Inquiry
An inquiry into quality and practice within the National Health Service arising from the actions of Rodney Ledward: published 2002;
The Report of The Royal Liverpool Children's Inquiry: published January 2001;
Learning from Bristol: the report of the public inquiry into children's heart surgery at the Bristol Royal Infirmary 1984 -1995: published July 2001;
The Shipman Inquiry Third Report: Death Certification and the Investigation of Deaths by Coroners: published July 2003;
The Shipman Inquiry Fourth Report: The Regulation of Controlled Drugs in the Community: published July 2004;
The Shipman Inquiry Fifth Report: Safeguarding Patients: Lessons from the Past - Proposals for the Future: published December 2004;
Committee of inquiry to investigate how the NHS handled allegations about the performance and conduct of Richard Neal: published August 2004;
Independent investigation into how the NHS handled allegations about the conduct of Clifford Ayling – published September 2004; and
The Kerr/Haslam Inquiry: published July 2005