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

In summary, the defendant’s position concerning scope of practice and supervision is this:

Professor Melville says that the development of standards and guidance for associates was an iterative process and it is not possible to pinpoint a single date on which the GMC decided not to set limits on associate practice. However, the defendant is an experienced regulator and, when determining how to set professional standards for associates, it had regard to the approach which it had taken in respect of doctors: that is, the provision of generalised standards of professional conduct requiring doctors to work within their limits of competence rather than the imposition of ceilings upon the practice. This was the defendant’s starting point. The regulation of doctors was well established and known to safeguard patients. Given the success of this approach, Prof. Melville said that “compelling reasons” would have been needed for the defendant to have taken a different and wholly untested approach to setting professional standards for associates. No such evidence emerged to suggest that a different approach was needed in the interests of patient safety

The validity of the initial approach was reinforced by a number of factors including the defendant’s understanding of the intention of the DHSC concerning regulation and strands of work undertaken by the MAPs programme. The DHSC had not sought to legislate to restrict the activities that associates could perform beyond the existing legislation which specifies activities that only doctors may do. On 1 April 2022, the DHSC shared with the defendant an early draft of what became the 2024 Order with the “supporting commentary” that “on review, we have not considered it necessary to make the duty to set standards wording any more specific. The GMC would satisfy this duty were it to set standards of the sort it currently sets using section 35 of the Medical Act (standards for professional conduct, professional performance and medical ethics).”

The MAPs programme included research into the approach taken to limiting the scope of practice of registrants by other healthcare regulators. None, save for the General Dental Council (“GDC”), set such limits. The Nursing and Midwifery Council (NMC) set common core professional standards of practice and behaviour for nurses, midwives and nursing associates and did not set limits on what could be done by, on the one hand, nurses or, on the other, by nursing associates. At a meeting with the GMC in October 2019, the NMC advised that it had not imposed any ceiling on the scope of practice of nursing associates in order not to fetter the development of the role. The HCPC guidance document “standards of conduct performance and ethics” sets common core standards for the fifteen professions regulated by that organisation.

The only healthcare regulator which has imposed limits is the GDC, which produced a “pared back” scope of practice for each separate profession setting out rules rather than high level principles. However, the GDC had commenced a review of its scope of practice guidance in 2019 and at its meeting with the defendant in October 2019 the GDC advised the defendant against defining the role of associate or its scope of practice as it had had the effect of inhibiting “growth of the profession and the role”. It reported that one of the effects of the limit on scope of practice had been that registrants’ focus was on not breaking the rules as opposed to acting in patients’ best interests. The GDC launched a consultation on its existing practices in February 2023 with the commentary that the proposed changes to its approach to scope of practice aimed to better support dental professionals to use their professional judgement to make decisions. The commentary continued that the review of the current guidance showed that it was no longer being used as originally intended and that it was being “widely interpreted by the dental professions as a comprehensive rather than indicative list of tasks”, which could “limit and restrict” a professional’s practice and could impact patient care.

Professor Melville said that the defendant’s early focus was upon whether, and to what extent, the defendant should adapt the core professional standards for use by associates. But the defendant became aware of serious concerns relating to scope of practice and supervision when it analysed the COI survey results in mid-2020 and again when it consulted on the proposed rules standards and guidance in March 2024.

The defendant undertook a question by question analysis of the COI survey results. Professor Melville noted that 59.8% of respondents agreed or strongly agreed with the statement that “PAs and AAs work safely for and effectively within a clearly defined scope of practice”. The responses suggested to the defendant that respondents understood that associates were working within a defined scope of practice agreed with their employers at the time. In addition 90% of respondents agreed with the question “do you think it is appropriate that PAs AAs adhere to the same professional standards as doctors in the four broad domains of GMP.” Professor Melville said that the answers provided reassurance that a model for associates based upon high level standards with scope of practice determined locally could be safe and effective.

The defendant noted however the concerns which emerged from the COI survey relating to associates’ scope of practice and their supervision.

Professor Melville says that:

Professor Melville concludes that the issues raised by respondents in the COI survey were carefully considered and resulted in amendments to the defendant’s approach but the defendant remained of the view that it was not appropriate to set a ceiling upon the specific activities which could be performed by PAs and AAs. In addition “to being contrary to our successful model for doctors, DHSC’s intent, and the advice received from other multi-professional regulators, if we had done so this would have inhibited career development of the individual’s role and of the AA and PA professional generally.” He said that the defendant did not have the expertise to set limits which were best set locally by employers with “overall responsibility to ensure that the PAs and AAs they employ are competent to undertake the activities and tasks they perform” and that the medical Royal Colleges had the clinical expertise to provide advice on limits “across all specialties and general practice.” He said that creating universal, hard and fast rules for all associates might restrict associates from undertaking work that they had the competence, experience and knowledge to perform which in turn would have a detrimental impact upon patient safety meaning, for example, that patients in the NHS have to wait longer for operations or treatment as associates would be limited in the assistance they could provide.

In November 2023 the defendant began the process of pre-consultation engagement on rules, standards and guidance for associates. Professor Melville says that the defendant spoke to 47 organisations including NHS employer organisations, associate representatives and doctor representatives. The public consultation was launched in March 2024 with the publication of “Regulating anaesthesia associates and physician associates, consultation on proposed rules, standards and guidance”. The consultation document set out that scope of practice of associates was not being consulted upon “because this depends on their skill and competence, which develop over time. We won’t determine scope of practice for PAs and AAs beyond initial qualification competencies just as we don’t for doctors….we know that NHS leadership, employer bodies and royal colleges have begun looking at how scope of practice may develop over time. We welcome those developments” .

Concerns relating to the scope of practice were nonetheless recorded and addressed in the consultation report. The report documented that: “although we do not set the scope of practice for associates as their regulator, we will set the learning outcomes that need to be achieved through education; standards that applicants must meet to enter the register, the registration requirements which must be passed by new graduates. Through these functions, we will ensure that only associates with knowledge skills and behaviours to work safely are entered on to the register. Once registered it is for employers to determine how best to deploy and utilise individuals safety to address local need.

Professor Melville explains that the concerns raised by Dr Marks in his statement were the reason why the defendant decided to apply the same high professional standards to associates. Many of the concerns are directly addressed by the duties in GMP. The core standards in GMP are supplemented by more detailed guidance to which associates and doctors must adhere. On 11 April 2024 the GMC published advice and guidance specific to the associate role covering information for associates; for doctors working with associates, for patients (concerning the role of associates) and for employers and supervisors. The advice and guidance was updated and replaced in December 2024. Professor Melville indicates that the supervision advice was to be collated and brought together into a single document (published April 2025).

Professor Melville refers to the specific examples of misdiagnoses by associates which are referred to by Dr Marks. Those incidents occurred before associates were regulated. He commented that, following regulation, it will be possible for the defendant to scrutinise patient safety issues raised with it.

He places the PFD reports in context, pointing out that a significant number of such reports (in which the role of healthcare professionals is a relevant factor of concern) are issued each year. There were 10 such reports concerning hospital related deaths published in a one week period in March/April 2025.

Concerning Emily Chesterton, he observes that there was no PFD report and the coroner did not otherwise contact the GMC to raise concerns. It was not therefore brought to the attention of the defendant by the coroner.

As to Benedict Peters, a PFD report was sent to the Trust. The Trust responded making it clear that the PA involved in the treatment had acted appropriately, that he had discussed the clinical picture with the Consultant Physician in Acute Medicine, who agreed with the diagnosis and plan formulated by the PA and went on to prescribe the discharge medication himself. The Trust remarked that in doing so the consultant was acting in the same way as he would had the case been presented to him by a junior doctor or nurse clinician seeking approval for their diagnosis and management plan. The Trust response emphasised that it was the professional responsibility of the supervising consultant to ensure that they have confidence in the information provided by the practitioner (be they doctor, nurse or PA) and to seek any additional information they require directly from the patient should they believe it necessary before reaching a clinical decision.

Although not brought to the attention of the defendant by the coroner, having reviewed the response, Professor Melville concluded that it did not raise patient safety concerns about associates.

In relation to Susan Pollitt and Pamela Marking, Professor Melville responded to the PFD reports on behalf of the defendant. He points out that, whilst the Marking report was generated following the commencement of regulation, the events which led to the PFD report being issued occurred before the defendant became regulator and the core standards did not apply to associates at that time.

He says that the defendant has not reviewed its guidance and standards in the light of the deaths but it has reviewed its guidance as part of its preparation for the regulation of associates.

Professor Melville makes the following further points:

Professor Melville says that the claimants’ assertion that the GMC does not consider that a patient has a right to know that they are being treated by an associate “is simply wrong”. The GMC has always been clear that associates are required to explain their role to patients and the amended version of GMP “puts this beyond doubt.”

Professor Melville sets out that the 2024 Order does not place a duty on the defendant to issue guidance for associates on obtaining informed consent. The GMC guidance document “Decision making and consent” does however require associates to be satisfied that they have consent or other valid authority before examining or treating patients. The document is not intended to be a full account of the law.