Mrs Justice Lambert DBE
Mrs Justice Lambert DBE:
Introduction
Physician Associates (PAs) and Anaesthesia Associates (AAs) were introduced into the UK healthcare system between 2002-2004. In October 2017, the Department of Health and Social Care (“DHSC”) described the medical associate role as “part of the wider healthcare workforce… trained to the medical model to augment service delivery alongside doctors. They are competent to practise in a range of specialties and can offer continuity of care, particularly in acute settings and GP practices. As such they are dependent practitioners, working within their sphere of competence releasing doctors to focus on more complex patient pathways and care whilst bolstering the healthcare team.” Associates are not medically qualified but are able to practise clinically following completion of an undergraduate degree (typically but not necessarily in the biosciences) and two years of clinically based experiential training.
The number of associates working in the UK healthcare system has steadily increased: at the end of 2024 there were approximately 6,000 associates, with this number projected to rise to 16,000 by 2030. This growth has been accompanied by a series of consultations which initially identified the case for, and subsequently refined the details of, a regulatory framework for associates. At the time this claim was filed, associates were not a regulated profession; this changed with the coming into force of the Anaesthesia Associates and Physician Associates Order 2024 (‘the 2024 Order’) on 13 December 2024. The defendant is the statutory regulatory body which has historically been responsible for regulating doctors in the UK, pursuant to the Medical Act 1983 (‘MA 1983’). By the 2024 Order, the defendant’s regulatory remit was extended beyond medical doctors to include a new role as regulator of PAs and AAs.
The First Claimant is a doctors’ advocacy body formed in 2023 by Dr Richard Marks and others; its purpose, as described in the Statement of Facts and Grounds (“SFG”), is to “air concerns about the plans to increase exponentially the number of associates in the NHS without an adequate, patient-safety focussed regulatory framework.” The Second and Third Claimants are the parents of Emily Chesterton, who died tragically of a pulmonary embolus in November 2022 due to the failure by the PA working at Ms Chesterton’s GP practice to refer her to hospital on two occasions. The First Interested Party in these proceedings is the British Medical Association (“the BMA”), the professional association and trade union for doctors and medical students across all branches of medicine across the UK. Its role is to represent and support UK doctors and medical students on issues impacting upon the medical profession. The Second, Third and Fourth Interested Parties were not represented and took no active part in the proceedings.
Underlying the application is the contention that the use of associates poses systemic risks to patient safety. Their training is shorter and far less comprehensive than even a newly qualified doctor; there is no career structure for associates following their initial training and they may be deployed anywhere within the health service based on the employer’s needs at the time. By contrast, it is said, doctors follow a career path of progressive specialisation. As Mr de la Mare KC for the claimants expressed it, there are no “tramlines” within which an associate works and therefore there can be no certainty or confidence in their training, skills and competence. The current regulatory position, which requires an associate to work within the limits of his or her competence, does not address the risk to public safety posed by associates because, unlike doctors, associates are unable to identify those safe limits and work within them. Further, although supervision by a doctor is required, in the absence of a defined career pathway, it is difficult for doctors to know the extent of the knowledge, skills and competence of the associate and delegate clinical tasks accordingly. Associates are therefore more likely to work outside their competence and to make mistakes with potentially very serious consequences. Those issues are compounded by the general public having little or no understanding of the associate role, and the assumption that they are being treated by doctors when in fact they are not. This ambiguity – which arises from the fact that associates are not required to explicitly state that they are not doctors before treating patients – means, it is alleged, that patients may not actually be giving informed consent to their treatment.
This claim was issued on 14 October 2024. Permission was granted on 13 January 2025. The SFG challenges the defendant’s ongoing failure to produce guidance, policies or otherwise set standards (including potentially by adopting guidance or policies produced by others) whether for the doctors delegating to and supervising associates (in its capacity as regulator of doctors) or for the associates themselves which:
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 state unequivocally that they are not medically qualified (ground 1(b)); and
ensure that associates are safely supervised by doctors, including when delegating appropriate clinical tasks (and supervising them as those tasks are carried out) (ground 1(c)).
In respect of each limb of ground 1 it is alleged that the defendant acted irrationally both in its decision making process and the outcome of that process and/or was in breach of the Padfield principle (see Padfield v Minister of Agriculture Fisheries & Food [1968] AC 997) by its failure to exercise the statutory powers conferred upon it by the MA 1983 and the 2024 Order for their statutory purposes.
In ground 2, it is alleged that the defendant has failed to comply with its Tameside duty of inquiry (Secretary of State for Education and Science v Tameside MBC [1977] AC 1014), by failing to gather and consider sufficient information to address the question of whether it should introduce the safe and lawful practice measures.
- Heading
- Mrs Justice Lambert DBE
- Background
- The Statutory Framework
- The 2024 Order
- Good Medical Practice and other guidance and advice issued by the GMC
- Supervision
- Claimants’ Evidence of Risk to Patient Safety
- Coroners’ investigations and Prevention of Future Death reports
- Mr Benedict Peters
- Mrs Pamela Ann Marking
- The Defendant’s Evidence: Professor Melville
- Scope of Practice and Supervision
- Ground 1
- Grounds 1(a) and 1(c): Scope of Practice and Supervision of Associates
- Ground 1(c): the Supervision and Delegation issue
- Ground 1: Discussion/Conclusion The scope of Ground 1: process and outcome rationality
- Ground 1(a) and Ground 1(c): process irrationality
- Outcome Irrationality
- Ground 1(b): Informed Consent
- Ground 1(b): Discussion/Conclusion
- Ground 2: Tameside duty of inquiry
- Ground 2 Discussion
- Conclusions
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