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,
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".
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 areasidentifying
and disseminating good practice, reviewing fitness to practise
decisions, and reviewing the performance of the regulatory bodiesCHRE
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.
8. Breaches of sexual boundaries by health
professionals are unacceptable. They can cause significant and
enduring harm to patients and they damage trustthe 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.
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
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.
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.
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.
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."
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
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.
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
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
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.
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.
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
Department of Health (2007) Trust, Assurance and Safety: the regulation
of health professionals in the 21st century. Back
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
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
CHRE. Section 29 cases referred to the High Court by CRHP/CHRE.
September 2008. Back
CHRE (2007) Protecting the public: learning from fitness to practise. Back
Department of Health (2007) Trust, Assurance and Safety: the regulation
of health professionals in the 21st century. Paragraph 1.25. Back
Shipman Inquiry (2004) Fifth Report-Safeguarding Patients: Lessons
from the Past-Proposals for the Future. Paragraph 159. Back
CHRE (2008) Performance review of health professions regulators
2007/08. Helping regulation to improve. Back
CHRE (September 2008), Advice to the Department of Health on aspects
of the establishment of the General Pharmaceutical Council. Back