Physician and Anaesthesia Associates: Delegation, Informed Consent, and Montgomery in the Administrative Court
26 September 2025
By Kian Leong Tan
INTRODUCTION
In R (Anaesthetists United Ltd and Others) v General Medical Council [2025] EWHC 2270 (Admin) (“Anaesthetists United”), Mrs Justice Lambert dismissed a judicial review claim brought by the claimants against the defendant regulator for Physician Associates (“PAs”) and Anaesthesia Associates (“AAs”) – collectively referred to hereafter as “Associates” – in the UK.
The claim is the most recent instalment in a brewing saga over the continued use and regulation of Associates in the UK’s healthcare system:
- In April 2025, Lambert J dismissed the British Medical Association (“BMA”)’s judicial review challenge (R (British Medical Association v General Medical Council [2025] EWHC 960 (Admin)) to the GMC’s decisions to (i) apply the same basic professional standards to doctors and Associates, and (ii) refer to all three professions collectively as ‘medical professionals’.
- Just prior to the handing down of Anaesthetists United, Professor Gillian Leng released her final report following the conclusion of her independent review into the Associate professions.
BACKGROUND FACTS AND THE LAW
Since the introduction of Associates into the UK healthcare system between 2002-2004, their numbers have steadily increased. Although not medically qualified, Associates can practise clinically after two years of clinically based experiential learning (having previously completed an undergraduate degree). They are dependent practitioners operating within a larger healthcare team, intended to free up doctors by taking over lower-level clinical tasks.
The GMC is the statutory regulator of medical practitioners in the UK. Section 1(1A) and (1B) of the Medical Act (“MA”) 1983 provides that its overriding objective is the protection of the public, which includes protecting, promoting and maintaining public safety and public confidence in the medical professions. On 13 December 2024, the Anaesthesia Associates and Physician Associates Order 2024 (“the 2024 Order”) came into force, extending the Defendant’s regulatory remit from its historical purview of doctors to include Associates. Up until that point, Associates had not been a regulated profession.
The 2024 Order effectively replicates the MA 1983’s regulatory scheme for doctors. Thus, among others, it imposes a duty on the GMC to set standards for and maintain a register of Associates. It is also empowered to bring fitness to practise proceedings against Associates and impose penalties for failing to meet those standards. Pursuant to the new legislation, the GMC has amended Good Medical Practice (the document setting out professional standards for doctors and Associates) and issued guidance and advice on various topics for both Associates, and the doctors supervising them.
The First Claimant, Anaesthetists United Ltd, is a doctors’ advocacy body formed in 2023 over concerns arising from the risks to patient safety from the use of Associates. The Second and Third Claimants were Marion and Brandon Chesterton, the parents of the late Emily Chesterton, who tragically died of a pulmonary embolus. An inquest into Emily’s death concluded that the PA treating her at her GP practice had misdiagnosed her condition and failed to refer her on to a hospital. Their claim was supported by the BMA, which appeared as an Interested Party to the proceedings.
The Claimants alleged that Associates – being less well trained and more likely to overestimate their own abilities when compared to doctors – pose a systemic risk to patient safety. This was borne out by numerous surveys and coroners’ Prevention of Future Death (“PFD”) reports, which highlighted that Associates and local NHS employers regularly flouted non-binding guidance and frequently acted outside of their competence. It was therefore irrational for the Defendant to simply replicate the existing doctors’ regulatory model. A firmer approach with clear tramlines on the clinical tasks which Associates could/could not perform was needed.
The Claimants challenged the Defendant’s “ongoing failure” to regulate Associates in a manner which complied with the overriding objective on two grounds:
Firstly, Ground 1 alleged that the Defendant had acted irrationally by failing to promulgate guidance, policies or set standards for Associates and the doctors supervising them. In particular, the Defendant had failed to:
- Set any or any adequate limits on the tasks Associates may undertake post-qualification (Ground 1(a));
- Ensure that informed patient consent is obtained for treatment by requiring Associates to unequivocally state that they are not doctors (Ground 1(b)); and
- Ensure that Associates are safely supervised by doctors, including when delegating clinical tasks and supervising them when those tasks were being carried out (Ground 1(c)).
These three elements were collectively termed the “safe and lawful practice measures” and were said to be the baseline for Associates to be able to operate safely.
Secondly, Ground 2 alleged a Tameside failure to gather and consider sufficient information to address the question of whether it should introduce the safe and lawful practice measures.
The Defendant contended that neither the overriding objective nor the 2024 Order required it to implement the safe and lawful practice measures. The incidents referenced by the Claimants, although tragic, had all occurred before the coming into force of the new regulatory scheme. Parliament had entrusted the Defendant to answer the policy question of the most suitable regulatory approach for Associates. The Court lacked the institutional knowledge to answer that question, a fact borne out by the very existence of the ongoing Leng Review. It was also entirely rational for the Defendant to have regard to its experience with the established doctors’ regulatory model. In any event, the Defendant’s decision-making process had been the product of an extensive information-gathering process spanning several years and had clearly considered the risks to patient safety when arriving at the overall balance.
THE DECISION
Preliminary objection – procedural rigour
The Defendant argued at the outset that contrary to the principle of procedural rigour as affirmed in R (Bibi) v SSHD [2025] EWCA Civ 622, the Claimants’ written and oral submissions had impermissibly expanded upon their pleadings (from only alleging outcome rationality, to now include process rationality) ([100]). Lambert J dismissed the argument, holding that the Defendant would not be prejudiced if the point was argued ([117]). Moreover, there was an element of artificiality in the Defendant’s attempt to separate process and outcome rationality. Per Saini J in R (Wells) v Parole Board [2019] EWHC 2710 (Admin), the decision-making process and outcome are inherently linked.
Grounds 1(a) and (c) – Safe limits and delegation/supervision
The Claimants argued grounds 1(a) and (c) together, noting that imposing limits upon the clinical tasks which can be safely performed by Associates itself addresses the questions of (i) how supervising doctors can assess the competence of their assigned Associates, and (ii) what clinical tasks they can therefore delegate (and the degree of hands-on supervision which might be needed). It was submitted that the Defendant’s starting point (to replicate the doctors’ regulatory model) was irrational, but so too was its failure to change course in the light of increasing evidence of the systemic risks posed by Associates to patient safety. The ongoing failure to act was also itself irrational.
Lambert J rejected both submissions. On process rationality, the Defendant was entitled to consider its extensive experience as a regulator for doctors, and its position was consistent with the advice it had received from other regulators including the General Dental Council ([123]). It had appropriately considered that the concerns raised by respondents about patient safety arising from its June 2020 community of interest survey could be addressed through the regulatory model ([124]). The PFD reports, although important, all concerned incidents predating the 2024 Order’s coming into force ([125]-[126]).
The very existence of the ongoing debate in the public arena (as evidenced by the Leng Review) was fatal to the outcome rationality challenge. It was not for the Court to enter the arena to decide policy questions for which it was ill-equipped to address ([134]-[136]). There was in any event widespread disagreement on whether it was for the Defendant, or other bodies with clinical knowledge (such as the Royal Colleges), to impose such limits ([137]).
Ground 1(b) – Informed patient consent
The Claimants argued that both (i) the statutory objectives of patient safety and public confidence (the primary submission), or (ii) the law on informed consent in Montgomery v Lanarkshire Health Board [2015] AC 1430 (the secondary submission) required patients to be made aware that they were being treated by Associates as opposed to doctors.
The parties’ disagreement ultimately boiled down to the question of whether, when carrying out clinical tasks which a patient reasonably assumed would be performed by a doctor, Associates were required to specifically disclose that they were not a doctor ([146]). The Defendant’s existing guidance did not explicitly include that instruction (although the Defendant suggested that any person correctly applying its guidance and advice would do so in an appropriate situation).
On the primary submission, it was said that the evidence overwhelmingly showed that the wider public did not know about the existence of Associates and automatically assumed that they were being treated by a doctor. The failure to require PAs in particular to explain their role and (lesser) qualifications to patients was therefore said to be both a public confidence and a patient safety issue.
Lambert J rejected the argument as being a counsel of perfection. Both the guidance in Good Medical Practice and elsewhere could be understood to the same effect as contended for by the Claimants. Notwithstanding that the point could have been explicitly made, it was not for the Court to conduct a detailed review of the drafting language or to suggest how it could be improved ([159]).
As to the secondary submission, in Montgomery the Supreme Court had held that doctors are required to take reasonable care to ensure that patients are made aware of any “material risks” of any recommended treatment. In so doing, the Court asserted the importance of patient autonomy and departed from the former model of ‘doctor knows best’ medical paternalism. In meeting this duty, doctors are now required to apply the test of materiality:
“87. …whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.”
The Claimants accepted that Montgomery was concerned with material risks arising from treatments but argued that the principle applied equally to risks arising from the person treating ([143]-[144]). That Associates are not medically qualified may be a material factor to a patient’s informed consent, influencing whether they might wish to seek a second opinion or obtain follow-up care elsewhere. It was also critical since without valid consent, any treatment may amount to battery.
The judge refused the invitation to make a “novel and very significant extension” of the Montgomery principle ([116]-[117]). No authority had been provided to support the proposition advanced. In any event, any such argument should be considered on the individual facts of a specific case, not in the abstract manner advanced here. The consequences could also be far-ranging: it could easily be argued by analogy that any medically qualified professional who fails to disclose that, e.g., they have never before carried out the specific treatment they are proposing; or that there are other medical colleagues who are more qualified to carry out the procedure might well be said to have run afoul of this broader principle. In circumstances where this could result in criminal sanctions for healthcare professionals, a wide-ranging extension such as this would be inappropriate.
Ground 2 – Tameside failure
Lambert J agreed with the Defendant that the question of the matter and intensity of the inquiry to be undertaken pursuant to its duties under the 2024 Order was ultimately for it to decide, subject only to Wednesbury unreasonableness ([173]). The Defendant had undertaken an extensive information-gathering process starting as early as October 2019 and continuing into the present day ([172]). Properly understood, the Claimants’ complaint was that the Defendant had not done enough; but that did not come anywhere close to meeting the threshold of irrationality. Ground 2 therefore failed.
COMMENTARY
Although Montgomery was concerned with doctors, the Supreme Court plainly considered that the principles set out in that case would also apply to other healthcare providers, specifically noting the diverse nature of a modern healthcare team (Montgomery, [75]). The heart of the issue lies in whether a patient’s right to receive information extends beyond information about the treatment itself to include information about the person treating them.
There are strong arguments on both sides. On the one hand, the right to make an informed decision about one’s healthcare must also include the right to refuse treatment from a particular provider. In this regard, there is a logical link between the material risks attached to a treatment and the person carrying it out – especially if they are not medically qualified. Indeed, as the BMA noted, the GMC’s own guidance for medical students includes an explicit requirement to disclose that they are not a doctor to patients, linking this back to the requirement to obtain informed patient consent ([149]).
On the other hand, imposing a requirement to disclose such information may well prove to be practically unworkable. It has certainly never been done before, although that is does not itself answer the question. More to the point, the potential for healthcare professionals to be drawn into extended, tangentially relevant explanations about their qualifications will only serve to exacerbate delays and pose further burdens for a struggling NHS. Being provided with a torrent of information may also arguably only serve to create greater anxiety for the patient who has quite enough to worry about.
It will be noted that Lambert J did not consider this ground unarguable per se, but rather that it would be better determined in an appropriate (clinical negligence) case. That is not surprising. A decade on, the precise scope of the rule in Montgomery continues to plague the courts. In McCulloch [2023] UKSC 26, the Supreme Court sought to rein in the impact of that decision by holding that healthcare professionals must be trusted to exercise their (clinical) judgment to identify which reasonable alternative treatments should be disclosed to a patient (but the identification of risks of a treatment remains a matter for the patient and the court). How those principles should apply to Associates (if at all) appears to be shaping up to be the next battleground on the horizon.
CONCLUSION
With the dust settling in the High Court, the litigation saga will now move on to the Court of Appeal. Permission to appeal against the earlier BMA judicial review was granted in July. Anaesthetists United have also applied to Lambert J for permission to appeal against her decision; and if refused will no doubt apply directly to the Court of Appeal. It remains to be seen how the Leng Review’s findings will feature at this stage, although it seems unlikely that any court would be prepared to go behind the detailed findings of the independent review. The GMC will also no doubt rely on the fact that Professor Leng specifically avoided recommending setting a scope of practice document for Associates.
The issues raised in these proceedings will also be of interest to clinical negligence practitioners. If it is ultimately the responsibility of individual supervising doctors to safely delegate clinical tasks to Associates, one can imagine cases where questions about whether an Associate’s competence was adequately assessed and/or if they were properly supervised will arise. So too questions about whether it was reasonable in the circumstances, applying the GMC’s guidance, for an Associate to fail to disclose that they are not, in fact, a doctor.
Montgomery, it seems, is on the move once again. Next stop – the Court of Appeal.
Kian Leong Tan is a future pupil barrister at 5 Essex Chambers. He assisted Lambert J as a Judicial Assistant during the Anaesthetists United trial. The opinions expressed here are his alone and are not representative in any way of Lambert J’s views.
