Consultation outcome

Regulating healthcare professionals, protecting the public: consultation response - executive summary

Updated 17 February 2023

Introduction

The government has committed to reforming the legislative framework for regulated health and care professionals across the UK. This is a rare and significant opportunity to deliver a large-scale programme of reform that will implement improvements to the system of professional regulation, to the health and care workforce and, most importantly, to patient and public safety. Successive governments have considered such reforms, but these have never come to fruition, until now.

The current UK model of regulation for healthcare professionals is rigid, complex and needs to change to better protect patients, support our health services and to help the workforce meet future challenges. The COVID-19 emergency highlighted how inflexible some of the regulators’ primary and secondary legislation is. For example, the Nursing and Midwifery Council (NMC), the Health and Care Professionals Council (HCPC) and the Pharmaceutical Society of Northern Ireland (PSNI) did not have powers allowing them to temporarily register individuals or groups to help respond to the COVID-19 emergency. In addition, the General Pharmaceutical Council (GPhC) and HCPC had to seek approval from the Privy Council to temporarily amend their rules to allow them to hold remote hearings during the pandemic.

It is vital that we get all of our changes right, which is why we have undertaken an extended period of stakeholder engagement and policy development, following the publication of Regulating healthcare professionals, protecting the public, to ensure that these reforms deliver a flexible and modern system of regulation for health and care professionals across the UK.

The responses to our consultation, which set out the detailed proposals for the reform of the legislation underpinning healthcare regulation, coupled with extensive stakeholder engagement will result in a set of finalised policy positions. These final positions will be used as the basis for drafting legislation that will give the GMC the power to effectively regulate anaesthesia associates and physician associates under the new regulatory framework.

Professional regulation reform

One of the key elements of our reform programme will be the introduction of a modern, fit for purpose regulatory system, which we will achieve by updating the legislative framework for each of the 9 health and care professional regulators. The 9 regulatory bodies in scope for these reforms are:

• General Chiropractic Council (GCC)
• General Dental Council (GDC)
• General Medical Council (GMC)
• General Optical Council (GOC)
• General Osteopathic Council (GOsC)
• General Pharmaceutical Council (GPhC)
• Health and Care Professions Council (HCPC)
• Nursing and Midwifery Council (NMC)
• Pharmaceutical Society of Northern Ireland (PSNI)

These reforms will span the 4 key areas of regulation:

• the governance and operating framework
• education and training
• registration
• fitness to practise

We will replace the regulators’ current legislation, through a series of statutory instruments, giving each regulator near identical powers through broadly similar legislation. In particular, we will provide each regulator with greater autonomy to set out the details of their regulatory procedures in legislation that they themselves publish, called rules. Regulators will be required to consult on their rules but will not need to secure the approval of Parliament or the Privy Council to make their rules, giving increased flexibility to rapidly adapt their processes and procedures to changing requirements.

We have engaged thoroughly with the regulators, the devolved legislatures in Scotland, Wales and Northern Ireland, the Professional Standards Authority for Health and Social Care (PSA) and other key stakeholders across the health and care, employment, commercial and legal sectors to ensure the first legislative draft provides the template framework for the rest of the regulators.

While we recognise that regulators may wish to take different approaches to regulating different professions, we expect much of this flexibility to be achieved through regulators’ rules created under the new flexible powers provided to each regulator.

We do however anticipate that there will be a small degree of variation between different regulators legislation but only where this is needed to reflect substantive differences in their roles or specific regulatory requirements for the professions that they regulate. This could include:

• the different professional titles protected in law
• any regulated activity which restricted professions can undertake such as ‘the practise of dentistry’ or ‘attending a birth’
• a regulator’s role in regulating businesses or premises

Replacing multiple pieces of legislation will be a long-term project, but we plan to work with each regulator to identify any variation to our template proposals, which will then be consulted on. Where possible, we envisage working on the legislation of multiple regulators at the same time to quicken the pace of the overall programme.

Sequencing of legislative reform

We are proposing to start our programme of reform with legislation, based on the final policy positions set out in this consultation response, that will provide the General Medical Council (GMC) with the powers needed to regulate AAs and PAs. The draft Anaesthesia Associates and Physician Associates Order (‘the draft order’) will be based on a new regulatory framework, which will be used as a template for the reforms of all regulatory bodies.

Alongside this response we have published the consultation on the draft legislation to regulate anaesthesia associates and physician associates. Following this 3-month consultation, responses will be analysed, and any necessary changes made to the draft order, before laying in Parliament in the second half of 2023 (subject to Parliamentary time). Once the legislation is laid, the GMC aim to complete their processes and preparations within 12 months, allowing regulation of anaesthesia associates (AAs) and physician associates (PAs) to commence in the second half of 2024. As the passage of legislation is subject to the Parliamentary timetable, we will keep the commencement provisions under review to ensure that regulation of AAs and PAs begins in timely fashion, while providing the GMC with the necessary time to prepare and consult on its rules.

We recognise that this is a delay to the previously published timetable for the regulation of AAs and PAs. Although this is in part due to the impact of the pandemic, it is important to note that this work is being taken forward as part of a broader package of reforms to regulators’ governing legislation, which is significant and complex. Under the previous plan, a single order would have introduced regulation for AAs and PAs and introduced reformed legislation for the GMC’s regulation of doctors, but with the reforms for doctors commencing later. Now we will bring forward a separate order that will bring AAs and PAs into regulation (based on the timetable outlined above) without changing the GMC’s regulatory framework for doctors in the first instance.

Reforming legislation for doctors

Reforming the GMC’s wider regulatory framework for doctors remains a key priority and we will continue to progress legislative drafting during the consultation period on the draft order to enable the swift implementation of the changes in relation to medical practitioners.

Reforming the GMC’s regulatory framework for doctors involves creating provisions to facilitate the transition from one regime to another (that is from the current framework for doctors to the reformed one), which requires significant detailed work. Given the previous plan had been to combine these changes into one order, but with a later commencement date for the reformed legislative framework for doctors, our intention and expectation is that this new approach will not introduce any additional delay to reforms to the GMC’s legislation that applies to doctors, or indeed the reforms for the remaining regulators or regulated professions.

The remaining regulators

The progress we are making with the draft order also places us in a good position to roll out these reforms to the other regulators.

While it is our intention to work as swiftly as possible to deliver reform for each regulator and profession, we will prioritise delivery of regulatory reform based on criteria including the size of registrant base, the need for reform, and regulators’ readiness to implement the changes.

Taking into account the aforementioned criteria, we intend to start working with the NMC and the HCPC, alongside the GMC, to develop reformed legislation for their professions over the next couple of years. The NMC is the largest regulator with over 750,000 registrants and has been prominent in its work to support the development of these reforms. Furthermore, the NMC has completed significant preparatory work to ensure readiness to implement these changes, including preparing draft rules. The HCPC regulates around 300,000 registrants across 15 professions (data recorded on 31 March 2022) and operates with particularly constrained fitness to practise legislation. Focussing on the GMC, the NMC and HCPC in the first instance will enable us to implement reform for the majority of regulated healthcare professionals within the next few years.

We will then progress to make changes for the remaining regulators taking in to account the criteria set out above. We also intend to implement any necessary changes to the legislation for the PSA, who oversees most of the regulators, where the reforms impact on the PSA and to ensure consistency within the field.

Wider programme of reform

Our reform programme reaches wider than developing a legislative framework for each of the health and care professional regulators. The recent Health and Care Act 2022 introduced changes to section 60 of the Health Act 1999, providing additional powers to make changes to the professional regulatory landscape through secondary legislation, which enable the:

• abolition of an individual health and care professional regulatory body where the professions concerned have been deregulated or are being regulated by another body
• removal of professions from regulation where regulation is no longer required for the protection of the public
• delegation of previously restricted functions to other regulatory bodies through legislation
• regulation of groups of workers concerned with physical or mental health of individuals, whether or not they are generally regarded as a profession, such as senior managers and leaders

In order to inform how government will use some of these powers, we commissioned 2 further workstreams:

• looking at the number of healthcare regulators and whether opportunities for simplifying the landscape exist
• reviewing and consulting on the criteria used to make decisions about which professions should be regulated and whether the current mix of regulated and unregulated professions is correct

Work to analyse the outputs of those reports and consultations are ongoing and will inform the future strategy for reforming the legislation of the remaining healthcare regulators. We will keep regulators and stakeholders updated on the progress of these projects and ensure comprehensive engagement on any proposals that might arise from them.

Consultation on reform

We consulted on our initial proposals for the reform of professional regulation from 24 March to 16 June 2021. Regulating healthcare professionals, protecting the public sought views on proposals to reform the regulation of healthcare professionals and to introduce statutory regulation of AAs and PAs. We received 525 responses from individuals, organisations, healthcare professionals and members of the public. Responses to the consultation showed clear support for changes to the legislative structure that underpins the regulatory bodies and the creation of a more consistent legislative framework.

The feedback confirmed which areas enjoy broad support for the policy intention and those where further consideration was, and is, required. We have used the time since the consultation ended to engage extensively with the regulatory bodies and other stakeholders to develop our policies further. Based on comprehensive discussions, and the feedback we received, some policies have changed. There is now a further opportunity to comment on these proposals through the consultation on the draft order, which has been published alongside this consultation response. Each regulator’s reformed legislation will also be subject to future consultation.

The consultation asked seventy questions on the 4 areas of reform we consulted on, as well as the introduction of regulation of AAs and PAs. A summary of our position is set out below and detailed analysis of the responses to the individual questions is provided in the consultation analysis document. The analysis document also provides a breakdown of the number of individual (further split into ‘members of the public’ and ‘healthcare professionals’) and organisation respondents, as well as their geographical location (where provided).

Governance and operating framework

The reforms in this area aim to provide the regulators with increased autonomy balanced with increased accountability. Our overall policy aim of providing a high-level legislative framework will enable regulators to make necessary changes to their processes without the restrictions of lengthy Parliamentary procedures and relying on Parliamentary time. In turn, there are measures in place to ensure regulators remain accountable for the decisions they make, for example through submitting evidence of the likely impact of any fee change in a reporting year, a requirement for regulatory activities to be carried out in a transparent manner and submitting annual reports to the devolved legislatures in Scotland, Wales and Northern Ireland. In the rare instance of a regulator failing to deliver its statutory functions there are steps that can be taken, such as putting into effect Privy Council’s default powers. The regulators, which are accountable to Parliament, can also be called before the Health and Social Care Select Committee (or equivalent in the devolved legislatures) at any time.

This greater freedom should not lead to regulators operating in isolation: there will be an onus on regulators working together and with wider stakeholders to deliver a modern system of professional regulation that promotes public protection across the health and care sector, for example through their duty to co-operate and collaborate with other regulators on areas which are common across the field, for example criteria for carrying out consultations.

While there has been much support for our policy proposals on the governance and operating framework of the regulators, a number of concerns were raised regarding the adequacy of the safeguards. We have addressed these concerns in the consultation analysis document.

Regulators will require broad data processing powers that allow them to carry out their functions effectively and to meet their over-arching objective of protecting the public. These data powers, together with a duty to co-operate with specified persons, will ensure regulation does not happen in isolation, and that regulators are able to work in partnership and operate within the wider health and care and education and training systems to deliver modern and effective professional regulation.

As outlined above, in the first instance legislation will be introduced to regulate AAs and PAs. This legislation will include some changes to the GMC’s governance and operating framework. However, the government and the GMC agree that doctors, AAs and PAs should be regulated under a single board structure and these provisions will form part of the second GMC order that reforms the regulatory system for doctors. We anticipate that further detailed discussions on the unitary board policy and drafting will be needed with the outcome of those discussions being reflected in the GMC’s second order.

Education and training

The reforms in this area aim to give regulators greater flexibility to determine how they set standards for, and quality assure, education and training. By removing overly prescriptive legislation and providing all regulators with broadly equivalent powers, the intended reforms will enable regulators to adapt more efficiently to changes in the healthcare environment and to the changing needs of service users and the general public. In turn, this will provide ongoing assurance that newly qualified professionals are equipped to offer safe and effective care.

The education and training reforms will provide the regulators with flexible tools to adapt the requirements to meet the future needs of the healthcare environment. For some regulators, they may choose to broadly maintain their existing education and training standards and processes (with the exception of the need to consider appeals).

The reforms will provide all regulators with a full range of powers to set standards in relation to:

• the outcomes of education and training
• specific courses and programmes of training
• education and training providers

These powers will provide assurance that approved courses are equipping learners with the skills, knowledge and experience that they need.

The regulators’ increased autonomy will be balanced by the duties set out in the governance and operating framework. This will require regulators to co-operate with organisations connected with the employment, education or training of healthcare professionals, as well as other regulatory bodies, and to operate in a proportionate way that considers the impact of how they use their powers on key stakeholders including current and prospective professionals, education providers and the public. Regulatory bodies will also be required to operate transparently, producing an annual report (where applicable) to the devolved legislatures in Scotland, Wales and Northern Ireland.

Registration

The reforms in this area focus on providing a high-level framework of requirements relating to the form of the register and the criteria for registration that are needed to maintain high standards of public protection.

We will provide regulators with the underpinning powers they need to uphold the integrity of the register and support public confidence in the regulatory system. We will enable regulators to determine the content of the register for each profession they regulate, and what information should be published to aid public protection.

The government believes that regulators hold the necessary expertise to determine the specific standards required to practise safely in a regulated healthcare profession. As such, the reformed legislation will enable regulators to set out many of the detailed requirements for registration in their own rules. Regulators will have greater flexibility to set out the routes to registration, as well as any conditions on registration. The provision of more flexible powers to set the requirements for registration and manage the procedural aspects of the registration system received strong support in the consultation and will enable regulators to create a simplified and efficient model of registration.

Following consultation and further engagement with stakeholders, some specific registration requirements, such as the need for registrants to hold adequate indemnity cover or insurance to ensure patients have access to appropriate levels of redress and compensation, will be retained in legislation. We believe that this approach strikes the right balance between autonomy for regulators and maintaining public confidence in the integrity of each register of healthcare professionals.

The reforms include a new duty for regulators to establish a periodic process of checking that registrants are continuing to meet the regulator’s standards of practice for their profession. This will provide assurance that registered healthcare professionals continue to develop their skills and competencies and acquire any new knowledge required to deliver safe and effective care.

The government welcomes the valuable contribution that overseas trained healthcare professionals make to the UK workforce. The reformed legislation will remove much of the prescriptive details setting out overseas registration requirements from the current legislation. This will give regulators the flexibility to set the specific standards for overseas professionals and determine how best to assess applications from these candidates in a proportionate way, in the context of their overarching objective of protecting the public.

Regulators will continue to have a legislative duty to set the standards of English language proficiency for registrants (while having regard to the government’s statutory guidance on English language proficiency for public sector workers) and will be provided with powers which can be used to require candidates to undertake practical assessments to confirm they meet registration standards.

We are working with the Department for Business and Trade to understand the impact of any mutual recognition obligations from international trade agreements on our reforms to regulators’ legislation.

These reforms will support the regulators to be more responsive to changing workforce and public protection needs, which was highlighted by consultation respondents as necessary to ensure that the UK’s healthcare workforce is able to meet the current and future care needs of patients.

Fitness to practise

The reforms in this area aim to provide greater consistency between regulators’ fitness to practise functions. Our proposed changes will deliver a fitness to practise process that is swifter, fairer and less adversarial, which will benefit all parties involved in fitness to practise proceedings and, most importantly, will ensure swift public protection where needed.

The initial assessment stage will enable regulators to determine whether a fitness to practise case should be referred to a case examiner to make a determination. We consider that this approach provides regulators with sufficient flexibility to determine which cases should be closed at initial assessment without taking any further action and which cases should be referred to a case examiner. A regulator will be able to appoint one or more case examiners to conclude a case.

Our reforms will enable more cases to be resolved without the need for a Fitness to Practise Panel hearing by introducing accepted outcome decisions made by case examiners. The introduction of a case examiner stage for all regulators will meet our reform aims of introducing a less adversarial fitness to practise model by enabling cases to be concluded more quickly. We will also introduce a broad range of measures which will be available to both case examiners and Fitness to Practise Panels to help ensure that restrictions to practise are proportionate and appropriate.

As now, regulators will be able to put in place an interim measure to restrict the practise of a registrant while a concern is investigated, where this is required to ensure public protection and/or registrant safety. Our proposals will also introduce automatic removal orders, to reduce the administrative burden on a regulator to find impairment where a registrant has been convicted of certain serious criminal offences. This will enable public protection to be delivered more quickly and uphold public confidence in regulated professionals.

There was broad support for a majority of our proposed fitness to practise reforms, with the majority of respondents agreeing that all regulators should have a 3-stage fitness to practise process including an initial assessment, a case examiner stage and a Fitness to Practise Panel stage.

However, there were some areas where there was no consensus from respondents to our proposed fitness to practise reforms. For example, we received mixed responses relating to our proposal that any current restrictions on regulators being able to consider concerns more than 5 years after they came to light should be removed from legislation. Having considered these responses in depth, we remain of the view that removing the 5-year rule is the right thing to do, and that it should be for case examiners and Fitness to Practise Panels to determine impairment with the time elapsed between an action giving rise to a concern and its investigation by a regulator being a relevant consideration, not a constraint, on whether regulatory action should be taken against a registrant.

Regulation of anaesthesia associates and physician associates

As set out in the consultation document, in order to bring AAs and PAs into regulation the GMC will be required to:

• register qualified and competent AAs and PAs
• set standards of education, training, knowledge, skills, experience, conduct, performance, ethics and English language
• operate fitness to practise procedures for both roles

The GMC’s powers will be extended to enable it to:

• approve and quality assure AA and PA education and training programmes
• determine which international qualifications it will recognise for the purposes of registration in the UK

Regulation will also mean that it will be an offence for someone, with intent to deceive, to:

• use the titles ‘anaesthesia associate’ or ‘physician associate’ if they are not registered as such with GMC (though note the transitional arrangements below)
• falsely represent anyone to have an approved qualification (which will cover AA and PA courses) or be registered
• make a false representation as to the content of the register
• procure, or attempt to procure, the inclusion or exclusion of information in the register

Transitional arrangements will be put in place to enable those AAs and PAs already practising to meet the requirements for registration with the GMC. The offence relating to the use of the titles ‘anaesthesia associate’ and ‘physician associate’ will not take effect until 2 years after the regulation start date.

Closing summary

In conclusion, these reforms will provide all 9 healthcare professional regulators with flexible, modern and efficient processes.

This represents a generational opportunity to fundamentally redesign the regulatory framework for healthcare professionals across the UK.

Regulators will get broadly similar powers, with greater flexibility to set out more of their day-to-day processes in rules and guidance.

This will deliver benefits for patients and service users, professionals, regulators and providers by enabling swifter, more responsive regulation, and will help regulators to support wider workforce flexibilities and adapt to future workforce challenges.