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

The claimants’ (and BMA’s) case is that there has been, and continues to be, a failure by the defendant to exercise its powers in relation to the creation of the new regulatory regime lawfully. The regime requires the introduction by the defendant of safe and lawful practice measures. The claimants’ pleaded case is that the only rational exercise of the regulatory powers contained in the 2024 Order is by the setting of nationally applicable limits on practice by reference to specific tasks which the associate profession are prohibited from undertaking even under supervision and irrespective of their post-qualification practice (and presumably experience). The limits should be set by the defendant or, if by a third party, then endorsed by the defendant.

The SFG sets out examples of the “outer limits or ceilings” beyond which it would never be appropriate for an associate to act instead of a qualified doctor. They include the prohibition on associates administering anaesthesia in paediatric or obstetric cases or other risky and complex cases such as major surgery on a patient with severe systemic disease (though provision could be made for genuine emergency situations). In oral submissions Mr de la Mare added the further example of a prohibition on associates seeing undifferentiated patients. These various prohibitions would remain even if the competency of associates evolves in their post-qualification practice.

Although the claimants’ submissions do not differentiate between the two, the challenge encompasses both process irrationality and outcome irrationality. Mr Dunlop submits that the claimants’ pleaded claim relates to the irrationality of the outcome, not the process by which it arrived at the outcome. The scope of the claimants’ case is therefore an issue for me to resolve.

The claimants’ main submissions (on both process and outcome rationality) are set out below. Many of the points which are made are derived from (or critique) the witness statements of Professor Melville. As I understand the claimants’ position, however, they do not accept that the reasoning and rationale in those statements is a true reflection of the defendant’s thinking at the time. Mr de la Mare points out that there is no contemporaneous document or set of documents in which the defendant appears to have grappled with the central issues concerning limits of practice and supervision or the evidence bearing on those questions. Further, the defendant’s initial response to the claim (in pre-action correspondence) challenged the existence of a power which would permit the defendant to impose limits of practice. Given this position, the claimants suggest that it is unlikely that the defendant gave any thought at all to the need for limits on practice and that from the outset the defendant adopted a “bright line” approach that such limits on scope of practice would not be part of the regulatory regime. The contents of Professor Melville’s witness statements are after-the-event rationalisations for the purpose of this litigation. As such, it is submitted they are not admissible to explain the defendant’s reasoning and I should disregard them. See R v Westminster City Council, ex parte Ermakov [1996] 2 All ER 302.

Notwithstanding this point, the claimants make the following submissions:

Mr Dunlop raises a preliminary objection to the scope of the claim in Ground 1. He contends that Ground 1 of the claim as pleaded is limited to an outcome rationality challenge to an ongoing state of affairs. He draws my attention to the pleaded case, which concerns the defendant’s ‘ongoing failures’ to impose the safe and lawful practice measures; and that this was reflected not only in the claimants’ SFG, but also the claim formand the relief sought (a declaration that the defendant is failing to fulfil its duties and lawfully exercise its powers). These are outcome rationality arguments. During the course of the claimants’ oral submissions, the arguments have been reframed to include process rationality arguments (e.g., that the defendant had adopted the wrong starting point; or that it had failed to reconsider its approach in the light of emerging evidence which allegedly establishes that associates pose a systemic risk to patient safety). This, Mr Dunlop submits, is impermissible. Had a process rationality complaint been pleaded, the defendant may have filed evidence directed to the particular aspects of the alleged flawed process, may have reconsidered one or more issues in a new formal decision or may have raised a defence under s. 31(3D) of the Senior Courts Act 1981. Mr Dunlop does not go so far as to submit that, when considering the rationality of the outcome, I should disregard the process by which the decision was reached. He accepts that the process may affect the margin of discretion available to the defendant. But he submits that the sole question for the court remains whether the outcome falls outside the range of reasonable responses. The case is about the defendant’s failure to set nationally applicable hard limits on what associates can (or cannot) do, whatever their experience, even under supervision.

The defendant denies that the current regulatory regime is “hollow” and rejects the complaint that it has done nothing meaningful to address the risks posed by associates. The defendant highlighted the requirements for registration (to become mandatory by December 2026), revalidation (albeit that this system is still currently being developed), and the fitness to practise process. In short:

The defendant accepts that the principal purpose of the 2024 Order is to protect the public, just as with the regulation of doctors the overarching function of regulation is patient safety. The defendant also accepts that its own COI survey raised serious concerns from a range of respondents about associates working beyond their competence; inadequate supervision of associates; associates failing to explain who they are to patients and patients themselves not knowing and understanding who associates are. The defendant accepts that those concerns were echoed in surveys conducted by others and in the coronial reports and that those concerns needed to be addressed. The question which arises in this claim is not whether there are concerns over safe associate practice but how those concerns are best addressed, whether they require the introduction of limits on practice and by whom they should be addressed. The claimants’ case is that those concerns can only, rationally, be addressed by the imposition of (further) limits on associates’ practice and that those (further) limits must be imposed by the defendant. For a number of reasons, including those set out in Professor Melville’s evidence, the defendant takes a different view.

Mr Dunlop submits that, logically, the case breaks down into two questions. First, whether it would be of net benefit to public protection for limits to be set on associates’ practice. Second, if so, is it irrational for the defendant not to set such limits.

Concerning the first question, Mr Dunlop accepts that there is scope for disagreement about whether national limits on associates’ practice further patient safety and that it is a topic upon which reasonable people may disagree. The claimants have presented the court with one side of the argument but, he argues, there is another side. There are “pros and cons” to the imposition of limits on the practice of associates. Mr Dunlop submits that I must be careful not to enter the debate and seek to resolve it. This would not only be an impermissible exercise of the court’s function but is a role the court is not equipped to fulfil. The court’s role in this application is limited to answering the question of whether the defendant’s approach is rational and therefore lawful.

An important downside to the imposition of limits on associates’ practice is that it might unduly restrict the contribution which associates can make to the NHS both now and in the future. Mr Dunlop submits that there is abundant evidence of a looming healthcare workforce gap over the next ten or so years. In this context associates will make an important contribution. The DHSC’s consultation document (which accompanied a draft of the 2024 Order) set out that “strengthening the future NHS workforce remains one of the government’s priorities.” It continued: “..associates are already a valued and integral part of the multi-disciplinary healthcare team but have the potential to make an even greater contribution.. The GMC is best placed to regulate the AAs and PAs as they form part of the medical team and are trained to the medical model. Regulation also paves the way for broadening their scope of practice by, for example requesting ionising radiation where local governance allows and, in the future, the possibility of being able to prescribe.” Mr Dunlop drew my attention to correspondence from the Academy of Medical Royal Colleges (the umbrella body for all Royal Colleges) to the BMA dated 6 March 2024 which suggested that broad profession-wide limits of practice were inappropriate. The author pointed to the dangers of broad profession wide limits commenting that the issue of scope of practice is “a complex issue which is both location and specialty specific.”

Mr Dunlop submitted that the best account of the pros and cons of imposing limits on associates’ practice is provided by the Professional Standards Authority’s (“the PSA”) submissions to the Leng Review dated March 2025. The PSA oversees all healthcare regulators. The Leng Review was set up by the government in autumn 2024. It is an independent review of the physician associate and anaesthesia associate professions by Professor Gillian Leng for the purpose of agreeing recommendations for the future. It will consider the safety of the roles and their contribution to multidisciplinary healthcare teams. It is described as an “end to end” review of associates’ practice covering; selection and recruitment; training; day to day work; scope of practice; oversight; supervision; professional regulation.

The PSA’s position on the topic of limits on practice is neutral. The object of the paper submitted to Professor Leng was to set out considerations in relation to scopes of practice of health and care professionals. It remarked that the issue of limits on practice had been central to debates about the safety of the physician associate and anaesthesia associate roles.

The PSA paper sets the question of limits on practice in context. The authors note that scopes of practice have not been a significant feature of professional regulation within the UK to date and that in the UK, the GDC is the only regulator to have defined scopes of practice for the roles which it regulates. The PSA has not, to date, taken a formal position in relation to the role of scopes of practice within professional regulation but it has been supportive of the GDC’s proposals to build greater flexibility into their scopes of practice for the dental team. It noted that scopes of practice have been relevant to debates about the regulation of advanced nursing practice and that for “several years now, people have been raising concerns about nurses and other professions working at an advanced level, undertaking tasks which, they argue, go beyond the scope of practice and training of registrants.”

The PSA highlights the scale of the workforce change which will be needed to deliver healthcare in the future with increasingly challenging economic and social circumstances, with an aging population with increasingly complex needs. This will require the development of new roles, and the evolution of existing roles. It is in the context of this potential work force gap that the PSA considered some of the unintended consequences, or potentially significant downsides, of defined scopes of practice. The PSA noted that the unintended consequences of defined scopes of practice was likely to be one of the central questions for Professor Leng.

The unintended consequences may include:

Mr Dunlop argues that the submission of the PSA to the Leng Review illustrates that the question of limits on practice is a complex issue which engages policy and political issues. The complexity and the nature of the issues engaged is further demonstrated by the fact of the Leng Review itself. Mr Dunlop agrees with the claimants that the Leng Review is of limited relevance to the claim, in the sense that Professor Leng’s conclusions, one way or another, will not have a direct bearing on the lawfulness of the decision making of the defendant. He submits however that the fact that the review is considering scope of practice and all aspects of associates’ working illustrates why it would be inappropriate for this court to rule on the topic. Importantly, the fact of the review underlines the inherently political and policy-based nature of the issues raised in the claim. Mr Dunlop therefore submits that it would be inappropriate for the court to resolve them even if there were not a review currently underway. Mr Dunlop submitted that it was not for me to “wade in” and rule on the rights and wrongs of the imposition of scopes of practice. The task of regulation had been entrusted by government to the defendant, and not to the court or the claimants and that it is not “for judges to weigh utilitarian calculations of social, economic or political preference.” I should guard against the danger of judges “wrongly though unconsciously substituting their own views for the views of the decision-maker who alone is charged and authorised by Parliament to exercise a discretion” see R v Secretary of State for Trade and Industry ex p Lonrho Plc [1989] 1 WLR 525) at 535. A Wednesbury challenge should not be used as “cover” for the court to impose what it considers as ideal solutions.

The question of whether to impose detailed profession-wide limits on the practice of PAs and AAs is a complex multi factorial policy question which is not appropriate for a court to determine in a claim for judicial review. It does not matter whether or not the defendant considered each (or any) of the factors informing the debate when determining not to impose limits on associates’ practice. The fact is there is a debate and it is one which engages policy and politics. This means that the outcome rationality ground must inevitably fail. The court cannot rule on whether the premise of the claimants’ criticisms is correct.

Mr Dunlop says that even if I were to find against him on the first question, the claimants have still failed to show that it was irrational for the defendant not to have set those limits. There are five main reasons for this submission: