Closed consultation

Healthcare regulation: deciding when statutory regulation is appropriate

Published 6 January 2022

Introduction

The purpose of the regulation of health and social care professions is to protect the public from the risk of harm from the provision of health and social care services. At the heart of any decision to regulate a profession is ensuring that statutory regulation provides the most effective and proportionate means of delivering this public protection function. The government and the devolved administrations are committed to ensuring that the regulation of healthcare professionals should continue to be delivered on a UK-wide basis.

Under the Health and Care Bill, the government is seeking additional legislative powers to ensure that the regulation of health and social care professionals is proportionate and best protects the public from harm. These additional powers are:

• the power to remove a profession from regulation

• the power to close down an individual health and care professional regulator

• the power to remove restrictions on the delegation of functions by the regulators

• clarifying that powers to introduce statutory regulation covers senior NHS managers and leaders and other groups of workers

This consultation considers how the powers to introduce and remove professions from regulation might be used in the future. It seeks views on the criteria that should be considered in assessing which professions should be regulated. These criteria will form the basis of assessing whether professions should be brought into, or taken out of, statutory regulation. It is our view that the current make-up of regulated and unregulated professions strikes the right balance in addressing the risks posed by health and care professionals without imposing unwarranted burdens. There are no plans across the 4 countries at present to either bring further professions into regulation in addition to physicians associates and anaesthesia associates, or to remove any professions from statutory regulation.

While this consultation is UK-wide and considers both health and social care professions, it does not consider the case for regulation of those working in the social care sectors in Scotland, Wales and Northern Ireland, where regulation of the social care workforce is a devolved matter.

This consultation is part of a broader programme of reform of the regulation of health and, in England, social care professionals. The government, on behalf of the 4 countries, has consulted on detailed proposals for reforming the legislation that underpins how the healthcare professional regulators operate in order to deliver better public protection through a simpler, more consistent and flexible system. We have also commissioned a review of the number of regulators. The Busting Bureaucracy review reported that stakeholders found having 9 separate professional regulators to be inefficient and confusing. This review will consider whether the current make-up of the regulatory landscape might be simplified to provide better public protection in a more efficient way.

Defining statutory regulation and when it is appropriate

Statutory regulation refers to health and care professions that must be registered with a professional regulatory body by law. The titles used by regulated professionals are also legally protected. It is an offence for an individual to describe themselves as, or hold themselves out to be a regulated healthcare professional (for example, a medical practitioner or registered nurse) without holding the appropriate registration with the relevant regulator. As such, employers must check that a person who intends to work in a regulated role is registered with the appropriate regulatory body. Registration with the professional regulator provides assurance an individual is fit to practise and has the necessary knowledge, skills and experience to practise in the relevant profession.

Statutory regulation is not appropriate for many health and social care practitioners as the level of oversight involved is disproportionate to the risk posed by a profession.

The risks associated with health and social care practitioners are managed in a number of ways. Many of these interact and provide a ‘continuum of assurance’ that provides oversight of risk at a number of levels. The ways in which standards of healthcare practitioners are assured include:

• individual healthcare professionals: risk management starts with the individual providing the health or social care service. Professionals working in health and social care want to do a good job and provide safe and effective care to those who require it. In providing those services safely, healthcare professionals will seek to ensure that they only carry out procedures for which they are properly trained and have the required knowledge, skills and expertise to complete

• employer/provider oversight: unregulated professions that provide their services through employers and/or regulated providers. This applies to most social care professionals in England and many healthcare professionals, including healthcare support workers. While the profession itself is not regulated, oversight is provided through the employer and, where applicable, system regulators (such as the Care Quality Commission in England and Healthcare Improvement Scotland). In many instances, this level of oversight is sufficient to address the risk that a profession poses. Teams working in a health and care setting collectively provide an internal quality assurance mechanism against which the provision of care to patients can be assessed. This provides for a further level of oversight without the need for statutory regulation

• disclosure and barring checks – the 4 countries operate and have access to services that are aimed at ensuring individuals who work with the public (for example, health and care professionals) are safe and, where individuals have exhibited past behaviour that makes them unsuitable, they are unable to work in such roles. These services include the Disclosure and Barring Service in England, Wales and Northern Ireland, and Disclosure Scotland and the Protecting Vulnerable Groups scheme in Scotland

• accredited register: accreditation of voluntary registers of professions that are not statutorily regulated by the Professional Standards Authority (PSA) provides an additional level of oversight of voluntary registers. Accreditation by the PSA provides assurance that a register meets standards in a number of areas, including protecting the public, complaints handling, governance, setting standards for registrants, education and training, and managing the register. For example, child psychotherapists are not regulated by law, but the register held by the Association of Child Psychotherapists is accredited under the accredited registers scheme

• statutory regulation: other professions are regulated by law, and it is a requirement to be registered with the relevant regulator in order to practise these professions. Statutory regulators:

  • maintain and hold a register of those qualified to practise in each regulated profession the regulator oversees

  • set the education and training requirements for entering a profession

  • set the standards of conduct and competence needed to continue to practise a profession

  • take action (fitness to practise) when concerns are raised about a registered professional

There are 9 regulators of healthcare professionals in the UK, regulating 34 professions across the UK. In addition, Social Work England is the regulator of social workers in England. The regulators are overseen by the PSA. There are also regulators of social care professionals in Scotland, Wales and Northern Ireland which are not overseen by the PSA. The full list of regulatory bodies and the professions that they regulate is at Annex A.

The 4 governments do not have any current plans to bring additional health or social care professions into statutory regulation, with the exception of physician associates and anaesthesia associates. Nor do they intend to remove any professions that are currently subject to statutory regulation.

This consultation seeks views on:

• the criteria used to assess whether a profession requires statutory regulation

• whether there are existing regulated professions that no longer need to be regulated

• whether there are unregulated professions that require statutory regulation

The criteria for deciding whether to regulate a profession

The decision on whether to regulate a profession is made by the government and is informed by a number of factors. At the heart of any such decision is an assessment of the risk of harm that a profession poses to patients and the wider public.

Risk of harm

In the context of health and social care professional regulation this means the risk of harm to the public through the provision of a service by members of a specific profession. Statutory regulation establishes a legal framework to manage this risk.

In ‘Right Touch Regulation’ the PSA identifies that the assessment of risk should involve both a qualitative and quantitative element:

• risk quantification seeks to gauge the likelihood of harm occurring and its severity (for example, the level of impact the harm would have on an individual)

• while risk qualification considers the nature of the harm (for example physical, emotional, psychological) and understanding how and why it occurs

The assessment of these risks should be based on evidence. Based on this assessment an informed decision can be made on whether statutory regulation is necessary or whether an alternative approach would adequately reduce risk. Regulation should only be introduced where it is the best method to manage risk.

Other factors that influence decisions on whether to regulate a profession

In addition to the risk of harm the following factors also need to be considered:

• proportionality – is statutory regulation, as the most comprehensive form of managing risk and harm for health and social care professions, the only way to ensure that the public is adequately protected? Where alternative options can be used to achieve the same outcome, these should be used rather than statutory regulation

• targeted regulation – by regulating a profession, what problem is being addressed and will regulation create unintended side-effects or new problems that hamper a profession’s ability to provide a service to the public?

• consistency – can effective regulation be achieved in a way that complements the existing regulatory framework, ensuring that the regulatory landscape can be easily understood by the public

Factors that are not relevant when deciding whether to regulate a profession

There are a number of factors that are sometimes considered to be a reason for regulating a profession but which should not form part of this assessment. These include:

• conferring status or esteem on a profession – statutory regulation is only appropriate where the potential risk of harm to patients is sufficient to warrant statutory oversight. While statutory regulation may be seen as conferring prestige on, and recognition of, a particular profession, this should not be part of assessing whether a profession should be regulated

• restricting access to a profession – statutory regulation introduces additional requirements on regulated professionals in order to assure public protection. This restricts access to the profession for individuals who do not meet the required standards. However, regulation must not be used to restrict access to a profession other than where that is required for public protection

While regulation aims to have a positive effect on public protection, there are other consequences of statutory regulation. These include:

• increased costs: registrants will experience increased costs as a result of being regulated both from the cost of meeting the requirements of registration and from fees charged for registration

• barriers to entry: a key element of regulation is the formalisation of education and training requirements for the professions. This can act as a barrier to entry to the profession for some individuals

The role of the PSA

The PSA may be asked to advise the government on whether professions that are subject to regulation should remain so, and whether unregulated professions should be brought into statutory regulation. It provided such advice when nursing associates were brought into regulation in England in 2019. The framework that the PSA uses to make these assessments is set out in its Right Touch Assurance document. Where government considers it useful, it may commission external bodies (such as the PSA) to provide advice on certain aspects of the criteria, before making a decision on whether to regulate a profession.

Do you agree or disagree that a qualitative and quantitative analysis of the risk of harm to patients is the most important factor to consider when deciding whether to regulate a health or care profession?

• Agree

• Disagree

• I don’t know

Please provide reasons for your answer.

Do you agree or disagree that proportionality, targeted regulation and consistency should also be considered in deciding whether to regulate a health or care profession?

• Agree

• Disagree

• I don’t know

Please provide reasons for your answer.

Alternatives to statutory regulation

Accredited registers

The PSA set up its accredited registers programme in 2012. The programme provides assurance of the standards of organisations that register health and care professionals that are not subject to statutory regulation. It does not directly provide assurance of the standards of individual practitioners.

The PSA describes the accredited registers as:

Help[ing] people get better care by ensuring that the health practitioners they register are competent and trustworthy. They set standards for people working in unregulated health and care occupations, encourage them to meet them and take action to protect the public when necessary. They ensure that the information they and their registrants provide is clear and helps people to make informed choices about the practitioner they want to see and about the treatments, therapies, care and products they offer.

They enable you to feel confident that the person you see is competent and trustworthy

They take action to protect you from risk

They work together to improve standards.

Where government and the devolved administrations do not consider that statutory regulation of a profession is required for a profession, we encourage organisations that register health and care professionals to seek accreditation from the PSA.

Regulated and unregulated professions

We believe that the current regulatory landscape is the correct one and that the mix of regulated and unregulated professions should not be changed (except for the introduction of statutory regulation for physician associates and anaesthesia associates). However, we are interested in seeking your views on:

1. whether, when considering the criteria for regulation, any regulated professions no longer meet the test for regulation and should no longer be regulated
2. whether any unregulated professions meet the criteria for regulation and should be statutorily regulated

Removing a profession from statutory regulation

The decision to remove a profession from statutory regulation is complex. There are very few examples across the world of professions being taken out of statutory regulation. The key question in considering this issue is one of risk to patients and service users.

The main risk, should a profession be considered for de-regulation, is that there may be a reduction in standards. This would need to be considered in the context of the alternative safeguards that would be available when statutory regulation came to an end, such as employer-led controls and the PSA’s accredited register programme.

Do you agree or disagree that the currently regulated professions continue to satisfy the criteria for regulation and should remain subject to statutory regulation?

• Agree

• Disagree

• I don’t know

Please provide reasons for your answer. If you disagree, please provide any evidence in relation to the criteria outlined above that supports a proposal to remove a currently regulated profession from statutory regulation.

Do you agree or disagree that currently unregulated professions should remain unregulated and not subject to statutory regulation?

• Agree

• Disagree

• I don’t know

Please provide reasons for your answer. If you disagree, please provide any evidence in relation to the criteria outlined above that supports a proposal to include a currently unregulated profession within statutory regulation.

Annex A: list of regulatory bodies and the professions they regulate

Regulator	Governing legislation	Professions regulated
Social Work England	Children and Social Work Act 2017	Social workers (England only)
The General Chiropractic Council (GCC)	Chiropractors Act 1994	Chiropractors
The General Dental Council (GDC)	Dentists Act 1984	Dentists Dental nurse Dental hygienist Dental therapist Dental technician Clinical dental technician Orthodontic therapist
The General Medical Council (GMC)	Medical Act 1983	Medical practitioners (doctors) Anaesthesia associates (to be introduced to regulation) Physician associates (to be introduced to regulation)
The General Optical Council (GOC)	Opticians Act 1989	Optometrists Dispensing opticians Student opticians Optical businesses
The General Osteopathic Council (GOsC)	Osteopaths Act 1993	Osteopaths
The General Pharmaceutical Council (GPhC)	Pharmacy Order 2010	Pharmacists (in England, Scotland and Wales) Pharmacy technicians (in England, Scotland and Wales) Registered pharmacies (in England, Scotland and Wales)
The Health and Care Professions Council (HCPC)	Health Professions Order 2001	Arts therapists Biomedical scientists Chiropodists or podiatrists Clinical scientists Dietitians Hearing aid dispensers Occupational therapists Operating department practitioners Orthoptists Paramedics Physiotherapists Practitioner psychologists Prosthetists or orthotists Radiographers Speech and language therapists
The Nursing and Midwifery Council (NMC)	Nursing and Midwifery Order 2001	Registered nurses Midwives Nursing associates (England only)
The Pharmaceutical Society of Northern Ireland (PSNI)	Pharmacy (Northern Ireland) Order 1976	Pharmacists (in Northern Ireland) Registered pharmacies (in Northern Ireland)