Select Committee on Health Written Evidence

Memorandum by the Council for Healthcare Regulatory Excellence (PS 72)



  1.  The Council for Healthcare Regulatory Excellence is an independent body accountable to Parliament. Our primary purpose is to promote the health, safety and well-being of patients and other members of the public. We scrutinise and oversee the health professions regulators[377], work with them to identify and promote good practice in regulation, carry out research, develop policy and provide advice on aspects of healthcare regulation for Ministers.

  2.  We welcome the Committee's inquiry into Patient Safety and in this submission, we draw on our experience since 2003 overseeing the work of the nine health professions regulators to consider the following questions set by the Committee:

    "1. What the risks to patient safety are and to what extent are they avoidable?"

    "2d. What the current effectiveness is of the following in ensuring patient safety: the National Patient Safety Agency and other bodies?"


  3.  The purpose of the regulation of health professions is to protect the public and enhance public trust. The regulation of health professions therefore has a very important role to play in relation to patient safety. The work of the individual regulators in setting standards for health professionals, maintaining a register of professionals, taking action where a professional's fitness to practise has been called into question, and in assuring the quality of education and training is all focused on public protection and patient safety. The regulators address particular risks to patient safety by for example:

    —  Restricting the practice of professionals whose fitness to practise is impaired

    —  Taking action to ensure that untrained/unqualified individuals do not practice as a health professional

    —  Promoting standards of conduct and competence to all registered professionals

  4.  CHRE was established in 2003 and the White Paper, Trust, Assurance and Safety, called for CHRE to be "an authoritative independent voice for patients on the regulation of professionals".[378] In the Health and Social Care Act 2008, CHRE acquired new responsibilities "to promote the health, safety and well-being of patients and other members of the public". In addition to our power to refer cases of "undue leniency" to court we have new powers to audit the initial stages of fitness to practise proceedings and in 2009 our performance review of the regulators will become a statutory report to Parliament.

  5.  From our work in three areas—identifying and disseminating good practice, reviewing fitness to practise decisions, and reviewing the performance of the regulatory bodies—CHRE considers that professional regulation can make a major impact on patient safety.


  6.  CHRE has a role in encouraging and sharing good practice between the regulators. In part this is delivered through exercising our powers to review fitness to practise decisions and our performance reviews of the health professions regulators.

  7.  In 2008 CHRE published guidance on clear sexual boundaries between health professionals and patients. This work was commissioned by the Department of Health in response to inquiries into serious breaches by health professionals, with the intention of bringing clarity to a difficult area and help regulators and those working in healthcare to prevent breaches of sexual boundaries by professionals.[379]

  8.  Breaches of sexual boundaries by health professionals are unacceptable. They can cause significant and enduring harm to patients and they damage trust—the patient's trust in the health professional and the public trust in health professionals in general. They also impair professional judgement. Sexual or inappropriate involvement with a patient may influence a health professional's decisions about care and treatment to the detriment of the patient.

  9.  CHRE produced guidance for health professions regulators, setting out the responsibilities of health professionals in relation to the maintenance of clear sexual boundaries with patients and their carers, and called on regulators to offer guidance to their registrants on this subject. We have enclosed copies of the project's reports for the Committee's interest.[380]


  10.  Under section 29 of the National Health Service Reform and Health Care Professions Act 2002 CHRE has the power to refer final decisions of fitness to practise panels of the regulators to Court if we consider the outcome is unduly lenient and it is necessary to do so for the protection of members of the public

  11.  This work has contributed to patient safety and public protection in two ways. Appeals to Court under section 29 have resulted in outcomes being changed and the public being better protected from individual health professionals who present a risk to the public. Of the 30 appeals with which we have proceeded under section 29, 28 have been upheld or settled by agreement with the regulator and health professional. We enclose a summary of the cases which have been appealed under section 29, which gives an indication of the seriousness of the types of cases with which we have dealt.[381]

  12.  Our work has also has increased public protection through improvements which the regulators have made to how they consider fitness to practise cases. These improvements have derived from the learning from Court judgments in cases that have been appealed cases and feedback which CHRE has provided to the regulators on cases which we have not appealed. Our most recent digest of feedback and learning points, together with case notes, is enclosed for the Committee's interest.[382]

  13.  The White Paper, Trust Assurance and Safety acknowledged the contribution of CHRE on the conduct of fitness to practise cases and their adjudication, improving the work of the panels and committees responsible for fitness to practise matters.[383] The impact of these powers on regulators and patient safety was anticipated by Dame Janet Smith in 2004. During her examination of the GMC's fitness to practise processes through the Shipman Inquiry, she commented:

    "There is a major reason to expect that change for the better might continue, namely the CRHP/CHRE. This is a new body but it has already made its mark by reason of its power to refer to the High Court any decision of the GMC which it considers to be unduly lenient and which it considers should be reviewed for the protection of members of the public. | Its existence will, I believe, have an important effect on the GMC. The GMC knows that, if it fails to act in the best interests of patients and the public, the CRHP/CHRE will intervene."[384]

  14.  In 2009 CHRE will start to audit the early stages of the regulators' fitness to practice cases as well as continuing to scrutinise their final outcomes.


  15.  As national organisations, the health professions regulators have considerable influence and impact on patient safety and public protection. CHRE has the power to investigate and report on the performance of the nine health professions regulators and we do this according to agreed standards relating to their five key functions:

Standards and guidance

  These standards look at how standards are set, how they promote patients' safety and well-being, how they are kept up-to-date and how the regulator ensures that registrants, employers and the public are aware of them.


  These standards look at registration processes, including identity and qualifications checks, how applicants from outside the UK are registered, and how easy it is for the public and employers to check an individual and find out if there are any limitations on their fitness to practise.

Fitness to practise

  These standards look at how concerns about fitness to practise are dealt with, and also how fitness to practise panel members are appointed, assessed and trained.


  These standards look at how regulators ensure students get the appropriate training to meet the needs of their profession, and how they quality assure education and training providers.

Governance and external relations

  These standards cover the effectiveness, efficiency, transparency and accountability of regulatory bodies. It also looks at how they foster a culture of continuous improvement and how they take account of stakeholders' views.

  16.  The performance review assesses how regulators are meeting their objectives of public protection. We have enclosed our 2007/2008 report for the Committee's interest, and here we summarise the broad themes and recommendations.[385]

  17.  There are differences in regulators' performance. In part this is derived from the requirements of their legislation or the differences in the nature of the professions they oversee. We found many areas where regulators were exhibiting good practice and these are highlighted in our report. But we also found that the quality of regulation and the level of public protection offered by the regulators differed.

  18.  It is apparent that the legislation governing health professions regulators can, on occasion, hamper their efforts in ensuring public protection. The details of these are highlighted in the enclosed report. We strongly urge the Department of Health, and where appropriate the Department of Health, Social Services and Public Safety in Northern Ireland to address these concerns through the current programme of reform arising out of the White Paper, Trust, Assurance and Safety, to enable the health professions regulators make a full contribution to patient safety.


  19.  In considering evidence and in making its recommendations we urge the Committee to recognise the role that effective regulation of health professions can play in patient safety and public protection and the potential it offers in delivering improvements in the future.

  20.  The nature of healthcare services is one of change, innovation and development. New patterns of service delivery emerge; new roles and innovative treatments can alter the risks to public protection and patient safety. The regulation of health professions in the UK is currently in the midst of a wide-ranging reform programme that in part is responding to these risks.

  21.  In our advice on aspects of the establishment of the new General Pharmaceutical Council, which we expect to publish shortly, we have stressed the importance of the ability of regulatory bodies to adapt quickly to change. In addition to the Better Regulation Executive's five principles of better regulation (that it should be proportionate, accountable, consistent, transparent and targeted) we propose a sixth: that it should be agile. It is vital that regulatory bodies are able to anticipate change in the practices of their registrants and the environments in which they work, and react quickly to it. This should be reflected in structures, standards, policies and processes.[386]

  22.  Developments at the European level also present challenges. The current draft directive on patients' rights in cross-border healthcare, in our view, presents some risks to patient safety. We are concerned at the continued omission of the ability of regulatory bodies legally to exchange information about registrants practising in a host state and to test communication competence of applicants as a criterion for practising their profession. These matters should have been enabled by the Directive 2005/36 Mutual Recognition of Professional Qualifications but were not. It is important to recognise that from the perspective of the European Commission health professionals have a fundamental right to move freely across Member States and national regulatory requirements may not impede this freedom. This has damaged the ability of regulatory bodies to ensure proper public protection and patient safety especially with temporary and occasional workers. We urge the Commission and parliament to establish a legal duty on regulators across Europe to exchange relevant regulatory information about registrants and to enable them to test communication competence of all EEA applicants. The gate-keeping role of the regulatory bodies is essential in ensuring public protection. This cannot be devolved reliably to employers without a statutory obligation and even then will not capture the self-employed. In these times of increasing plurality of provision of healthcare services the integrity of the regulatory bodies must not be undermined. Their robust gate-keeping function is necessary as the most reliable method in ensuring public protection and patient safety.

  23.  We believe that the contribution that regulation of health professions can make to patient safety and public protection is significant, and could be still greater. CHRE's performance reviews and section 29 learning points have highlighted the willingness of regulatory bodies to improve their practice. The challenge for the health professions regulators is therefore the ability to be flexible and agile in responding to emerging challenges while maintaining their day to day operations. Our concern at the legislative brakes on regulators' operations highlighted in our 2007/08 Performance Review will continue until they are adequately addressed by the relevant Departments.

September 2008

377   General Chiropractic Council, General Dental Council, General Medical Council, General Optical Council, General Osteopathic Council, Health Professions Council, Nursing and Midwifery Council, Pharmaceutical Society of Northern Ireland, Royal Pharmaceutical Society of Great Britain. Back

378   Department of Health (2007) Trust, Assurance and Safety: the regulation of health professionals in the 21st century. Back

379   Department of Health (2007) Safeguarding patients. The Government's response to the recommendations of the Shipman Inquiry's fifth report and to the recommendations of the Ayling, Neale and Kerr/Haslam Inquiries. paragraph 6.4. Back

380   CHRE (2008) Clear sexual boundaries between healthcare professionals and patients: responsibilities of healthcare professionals. CHRE (2008) Clear sexual boundaries between healthcare professionals and patients: guidance for fitness to practise panels. CHRE (2008) Learning about sexual boundaries between healthcare professionals and patients: a report on education and training. Halter M, Brown H, Stone J (2007) Sexual boundary violations by health professionals-an overview of the published empirical literature. CHRE. Back

381   CHRE. Section 29 cases referred to the High Court by CRHP/CHRE. September 2008. Back

382   CHRE (2007) Protecting the public: learning from fitness to practise. Back

383   Department of Health (2007) Trust, Assurance and Safety: the regulation of health professionals in the 21st century. Paragraph 1.25. Back

384   Shipman Inquiry (2004) Fifth Report-Safeguarding Patients: Lessons from the Past-Proposals for the Future. Paragraph 159. Back

385   CHRE (2008) Performance review of health professions regulators 2007/08. Helping regulation to improve. Back

386   CHRE (September 2008), Advice to the Department of Health on aspects of the establishment of the General Pharmaceutical Council. Back

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