AC-2024-LON-003354 - [2025] EWHC 2270 (Admin)

Fecha: 05-Sep-2025

Background

Background

The regulation of associates developed following a series of consultations run by the DHSC. These consultations were separate from, but also informed and were in turn informed by, the defendant’s own preparatory work in anticipation of its new regulatory responsibilities.

10.

The DHSC’s consultation process included the following:

(a)

In October 2017, a consultation document on the regulation of ‘medical associate professions’ (including PAs and AAs) in the UK was published. It sought views on proposals to introduce specific statutory regulation for associates. It recognised the increased use of these roles within multi-disciplinary teams, and the need to explore the options for statutory professional regulation and the appropriate healthcare regulator. Preparatory work done by Health Education England was incorporated into the 2017 consultation document and included the application of a risk assessment model devised by the Professional Standards Authority which concluded that PAs and AAs posed ‘medium’ to ‘high’ risks to patients. The consultation document explains the conclusions.

(i)

In respect of PAs, the high risk arose from: ‘the wide ranging scope of the PA role including the provision of direct and interventional care to patients, the environments they work in (particularly primary care) and the level of direct supervision they are subject to.’

(ii)

As to AAs, ‘… the types of intervention [AAs] make on a routine basis are high risk … [W]e understand that a proportion of [AAs] work beyond the agreed scope of practice for the role, performing additional tasks with limited supervision … Although this extended practice is managed under local governance structures…there are no universal standards or training in these extended practices as part of the approved [AA] training course. This creates the potential for inconsistency across the profession and could pose a risk to patient safety.’

(b)

The DHSC’s response to the consultation was published in February 2019. It concluded that associates should be regulated but that more work was needed to identify whether the defendant or the Health and Care Professions Council (HCPC) would be the more appropriate regulator.

(c)

On 18 July 2019 the Minister of State for Health announced that the defendant had been selected to regulate associates across the UK, on the grounds that the GMC was “best placed” to regulate and “regulation will enable these groups to work to their full potential and provide the very best care to patients as part of a multi-disciplinary team.”

(d)

In 2021, a further DHSC consultation (‘Regulating healthcare professionals, protecting the public’) was launched, which recognised that certain statutory changes would need to be made to reflect the expansion of the defendant’s regulatory remit, and sought input from respondents on the proposed regulatory framework for associates. The DHSC’s response was published on 17 February 2023, which largely reaffirmed what had been set out in the consultation document.

(e)

In 2023, a third consultation, ‘Regulating anaesthesia associates and physician associates’ was launched which invited views on the specific legislative provisions which would form the statutory framework for the defendant’s regulation of associates. The Executive Summary provided an overview of the ‘core functions’ of a regulator, including (a) education and training, (b) registration requirements, (c) standards and guidance, and (d) fitness to practise. The response to this consultation was published on 11 December 2023, which reflected the government’s view on the necessary elements of the regulatory framework, including a draft of the 2024 Order.

11.

Following the announcement that the GMC was to regulate associates, the defendant established a work programme (the Medical Associate Professions or “MAPS” programme) to implement the regulatory framework for PAs and AAs. These included seven work streams covering various regulatory functions (professional standards, education, registration, fitness to practise), which reported to the MAPS Programme Board. The MAPS Programme sat alongside a wider Regulatory Reform Programme Board, which looked at issues relevant to regulatory reform in respect of all regulated medical professions. The MAPS programme regularly submitted reports on its work to the defendant’s Executive Board and Council, the latter of which approved the current approach to regulating associates.

12.

From late 2019 onwards, the MAPS programme took a number of steps as part of its information-gathering process. These steps included:

(a)

between late 2019 and early 2020, a literature review to identify professional standards issues for associates and initial engagements with other key stakeholders including the Association of Anaesthesia Associates, Faculty of Physician Associates (FPA), and Royal College of Anaesthetists (RCA) to find out how the current regulatory guidance Good Medical Practice (“GMP”) was being used by associates ‘on the ground’;

(b)

a consultation process with other regulators to determine their approaches to regulation of ancillary professionals, including concerning the introduction of a scope of practice or some other form of limitation on the practice of associates or equivalent;

(c)

in December 2019, the launching of a “community of interest” (“COI”) via a blog post. Its purpose was to work closely with associates and those who worked with associates. In June 2020 the defendant undertook a survey of members of the community of interest. It received 1147 responses from associates, doctors, students, nurses and other healthcare professionals. 7 members of the public responded. A report setting out the survey results was published on the defendant’s website;

(d)

between December 2020 and January 2021, engagement with seven focus groups involving doctors and associates throughout the UK and across primary and secondary care settings to develop thinking on professional standards that should apply to associates;

(e)

the setting up of an External Advisory Group made up of the DHSC, BMA, Royal Colleges and other stakeholders. Its function was to “advis[e] the GMC on the design of the regulatory framework for the Physician and Anaesthesia Associates and [to advise] on prioritisation, opportunities, risks and potential sensitivities within the overall development plan.” 18 meetings of the EAG were held between November 2019 and October 2024;

(f)

the creation of an Advisory Forum of external experts to act as a ‘critical friend and sounding board’ for key decisions in the development of new core standards for Associates. Seven meetings were held between 8 September 2021 and 30 January 2023.

13.

In addition to the MAPS programme’s work, the defendant ran two public consultations on GMP:

(a)

April-July 2022: A public consultation seeking feedback on proposals to ‘have one set of core professional guidance for all medical professionals registered with us’ and to ‘keep the guidance concise … as high-level principles and duties’. These subsequently led to the publication of a draft of new standards guidance on 22 August 2023, which came into effect on 30 January 2024.

(b)

March 2024: A public consultation ‘Regulating anaesthesia associates and physician associates: consultation on our proposed rules, standards and guidance.” Following this consultation, the defendant approved a series of amendments to GMP on 7 November 2024.

14.

On or around 11 April 2024, the defendant published on its website advice and guidance specific to the role of AAs and PAs. The materials covered:

(a)

information for associates on registration, professional standards and revalidation;

(b)

information for doctors about associates and working with associates including supervision and working within competence;

(c)

information about patients about the role of associates, the benefits of regulation and how to raise a concern.

15.

The 2024 Order came into force on 13 December 2024. Prior to this Order there had been no statutory regulation of associates. Under the 2024 Order, Article 19(1)(b), which relates to the use of the title anaesthesia or physician associate, does not take effect until 13 December 2026. There is therefore a two-year transition period for individuals with a relevant associate qualification who are practising as associates in the UK to gain registration. Any person who is not on the register of PAs and AAs by 12 December 2026 can no longer use the protected title of PA or AA.

16.

The defendant produced amended rules setting out the procedural requirements for admission to the register and a Registration Evidence Framework describing the “overarching approach” to how associate applicants are able to demonstrate registration standards and information requirements. The Framework sets out the evidence requirements for education and training; knowledge and skills; experience and performance; conduct and ethics and language. Applicants are required to, amongst other things, provide evidence of their knowledge and skills which demonstrate that they are able to “safely and effectively apply their learning within the context of UK practice and to the requisite standard.” The standard will be met by providing evidence of passing a GMC-approved registration assessment and by testing the core knowledge, skills and behaviours of applicants. Each of the approved registration assessments has two elements: a knowledge test and an assessment of clinical/practical skills.

17.

The defendant issued updated advice and guidance on 16 December 2024 addressing (among other things) clinical governance, scope, supervision, working within competence and introductions.

18.

In February 2025, the defendant published updated guidance on PAs and AAs in practice. In April 2025, the defendant published on its ethical hub “Supervision of physician associates and anaesthesia associates.”