Outcome Irrationality
Outcome Irrationality
The question for me here is whether the defendant’s decision not to impose limits of practice for the purpose of patient safety was one which was within the range of reasonable decisions open to it. This raises two further questions: first, whether patient safety requires the imposition of limits on associates’ practice and second, if so, whether the defendant is the body which must introduce such limits.
I accept that there are patient safety advantages to the introduction of fixed limits on the practice of associates. Those patient safety advantages have been set out in detail by the claimants and are self-evident: the imposition of a general prohibition on associates undertaking certain tasks or performing certain functions means that all risks associated with that activity are eradicated. But I also accept that there are downsides to imposing such limits in practice.
Professor Melville referred to various downsides in his evidence. He noted that the creation of hard and fast rules for all associates might restrict associates from undertaking work that they had the competence and experience to perform safely. This in turn may have a detrimental impact upon patient safety overall because a potentially valuable resource is not being utilised. He noted that the defendant’s engagement with other regulators suggested that it would be preferable “to avoid defining roles or scopes of practice because that would inhibit growth of the profession and the role.” This view underpinned the GDC’s desire to move away from a prescriptive rules-based approach to standards. Professor Melville referred to the possibility of such ceilings on practice fettering the development of the individual associate.
The submission of the PSA to the Leng Review reveals perhaps a fuller range of policy issues. It also places those issues in their relevant economic and social context. The associate profession is expected to make an important contribution to the healthcare workforce over coming years. NHS England has set out in its NHS Long Term Workforce Plan that the number of people aged over 85 years is estimated to grow by 55% by 2037 and that without “concerted and immediate action” the NHS will face a workforce gap of more than 260,000 – 360,000 staff by 2036/37. The impetus from the government is to increase the scope of associates’ practice to include tasks currently prohibited (for example, prescribing), the object being that they are able, under supervision, to perform tasks which will free up doctors for the more complex work. Whilst I agree that this may on the one hand suggest the need, perhaps the strong need, for appropriately defined limits on practice, the authors of the PSA submission point out a range of other countervailing considerations. I also agree that the fact of the Leng Review, an “end to end” review of safe working practices of associates, confirms the existence of a genuine debate engaging a range of stakeholders and policy issues, economic and social.
I am satisfied therefore that there exists a genuine debate about whether the imposition of national limits on the practice of associates is overall in the interests of patient safety. The GDC’s experience is particularly relevant. As the only regulator to have imposed a “pared down” version of a scope of practice on its registrants, it is now actively reviewing that decision in favour of a less prescriptive approach which would “enable dental professionals to use professional judgment to make decisions in the interests of their patients.” Its experience has been that the scope of practice was limiting and restricting a professional’s practice which could impact patient care. Further, the fact that the balance sheet is not loaded on one side only is spelt out by the fact of the Leng Review, the submission of the PSA to that Review and the defendant’s own findings.
The existence of this debate is fatal to ground 1(a) of this claim. It is not for me to enter the debate and resolve it one way or the other. That is not this court’s role: my only role is to determine whether the defendant’s decision not to impose a ceiling on practice is irrational. Further, this court is simply not equipped to weigh complex social, political and economic issues and then express a concluded view on the pros and cons of limits of practice. This may be a matter for Professor Leng in her wide-ranging inquiry but it is not a matter for me.
Mr de la Mare seeks to address this issue by arguing that the defendant itself did not undertake the sort of “meaningful polycentric balancing” to which the defendant refers. By “meaningful polycentric balancing”, I understand him to be referring to the weighing of the various pros and cons of the imposition on limits. But this misses the point. The fact that the defendant did not engage with the detail of the social, economic and political issues connected to the looming work-force gap is not relevant. There is robust evidence before me that the debate exists and has yet to be resolved. If there is evidence of a range of opinion, particularly one involving economic and policy issues, then the court is not equipped to judge the issue, irrespective of whether those points featured in the defendant’s approach. I agree with Mr Dunlop that the fact that political and policy decisions may not have influenced the decision maker does not matter, although in this case, whilst perhaps not expressed in exactly the same way, the defendant’s thinking was influenced by the need not to fetter the development of competent associates or to restrict their potentially valuable role as members of the healthcare workforce which might impact negatively on patient safety.
I am satisfied that the defendant’s decision not to impose national limits on associates’ practice was rational for another reason. Even if the imposition of national limits of practice were the only rational outcome to the debate which I refer to above, then I am satisfied that it was not irrational for the defendant not to impose those limits for the following reasons:
Outside this litigation, no one (including the First Claimant and the BMA) has suggested that the defendant is best placed to define such limits. The Chair of the Royal Academy (the umbrella body of the Royal Colleges) wrote to the BMA on 6 March 2024 (in response to the production by the BMA of a scope of practice) to say that it had been “inappropriate” for the BMA to draft the scope of practice and that “the issue fell firmly within our area of responsibility.” The Chair informed that BMA that work on the project had been underway for many months “within the Academy and among the colleges and faculties.” There was no suggestion from that organisation that the defendant was best placed to draft national limits of practice. On the contrary, the issue fell firmly within the remit of the Royal Colleges.
The defendant itself does not accept that it has the expertise to define tasks and functions which are off limits to associates in primary care, medical and anaesthetic practice. Nor does the defendant consider it appropriate to simply “endorse” a scope of practice drafted by one of the Royal Colleges (see above at para. 89(b).
The defendant does not assert that there is no role for limits on practice. On the contrary, as I understand Professor Melville’s evidence, individual limits are, or may be, appropriate and developed in discussion between the named supervisor and the associate and taking into account the experience of the associate. In this context:
The defendant has promulgated Supervision Practice Advice (April 2025) which sets out, amongst other things, the role of the named supervisor. Part of that role is to determine the competence of the associate and with that the level of supervision required. It sets out how a doctor, other than a named supervisor, can find out the range of tasks and the extent of the competence of the associate.
The defendant has taken into account local clinical governance arrangements on the basis that patient safety is not the remit solely of the regulator. In its December 2024 guidance the defendant sets out that “effective clinical governance systems are vital to make sure that PAs and AAs are properly and safely deployed. Organisations that employ PAs and AAs should make sure their governance arrangements take into account that these professionals are trained and will be registered on the basis that they will always work under supervision.”
For these reasons I dismiss ground 1(a). I am satisfied that the defendant’s exercise of its role as regulator of associates was coherent and rational. I am against the claimants on both the process and outcome challenge. I make two further points:
First, the precautionary principle referred to by Mr de la Mare adds nothing to the ordinary application of the Wednesbury test: see Plan B Earth v Secretary of State for Transport [2020] EWCA Civ 214 at [73-75].
Second, even if I am wrong on the question of whether the process adopted by the defendant was irrational and that the defendant either failed to take into account a mandatory consideration or there was a logical gap in the defendant’s reasoning, I am quite satisfied that, but for any such defect of reasoning, the outcome for the claimant would have been highly likely to be the same. That being so, I would have been obliged to refuse relief under s. 31(2A) of the Senior Courts Act 1981.
I also dismiss ground 1(c). It seems to me that grounds 1(a) and 1(c) go hand in hand given the claimants’ case that, absent defined limits of practice, delegation of tasks and supervision of associates cannot be safely undertaken.
I add however that to the extent that there was ever a free-standing challenge to the defendant’s failure to set standards and produce guidance on safe supervision of associates by doctors, any such challenge has been completely answered by the promulgation of the April 2025 “Supervision Practice Advice.” There was no objection to my reading this document (and others which post-dated the issue of the claim) and taking it (and others) into account. Its development and imminent publication was heralded by Professor Melville in his first statement. It was not, I find, a response to the claim (as at one stage suggested by Mr de la Mare) given its genesis some months before the claim was issued and a disclosure application seeking underlying documents was not pursued. In any event, such challenges to this publication as maintained by Mr de la Mare and Ms Richards at the hearing are, as Mr Dunlop characterises them, challenges to its “granularity” or detail only. A lack of detail in a guidance document does not make it unlawful or irrational. I dismiss this ground also.
- 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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