AC-2024-LON-001142 - [2025] EWHC 2015 (Admin)

Process irrationality

Under this ground, the claimants say that, although the CQC had acknowledged that the NHS position relating to safeguards for the hormone treatment was a relevant consideration, it had then omitted to take into account a number of obviously material factors, which were either apparent from the material before it or into which it ought reasonably to have enquired but did not. Applying a heightened standard of review to the process adopted by the CQC, I have separately considered each of the factors thus identified, before standing back to assess the process as a whole.

Referrals to IP1 by non-CQC regulated entity. The first matter relied on by the claimants is the fact that, within the NHS, only CQC regulated entities can refer 16 and 17 year olds for the hormone treatment whereas referrals to IP1 are made by Kelly Psychology, which is not CQC-regulated. The claimants complain that there was no reference to this point in the registration decision, and, to the extent referenced at the assessment stage, there was a failure to have regard to how this reduced safeguards for patients; as a referral is not a neutral act but a positive recommendation for treatment, the claimants say this was an obviously relevant distinction giving rise to an enhanced risk to patient safety.

In considering this point, it is necessary to be clear that the objection relates specifically to the fact that Kelly Psychology is not regulated by the CQC; the conduct of every psychologist employed by Kelly Psychology is regulated by the Health and Care Professions Council, and the conduct of every psychotherapist by the UK Council for Psychotherapy. As for the fact that Kelly Psychology does not fall within the remit of the CQC, it is apparent that those involved in the registration and assessment decisions (and, therefore, in determining whether or not to impose additional conditions on IP1’s registration) were clearly aware of this (indeed, this was a point referenced by Ms Huntley in her statement in these proceedings before it had been highlighted as a materially relevant consideration by the claimants). Given the CQC’s understanding of the entities that would, and would not, fall under its ambit of responsibility, I would not readily infer that a failure to expressly reference this feature (a not uncommon distinction between the NHS and private sector, which will exist in many CQC registration and assessment decisions) demonstrates that it was not taken into account.

Moreover, looking for an acknowledgement of the materiality of this point as if this was some form of tick-box exercise fails to engage with the substance of the CQC’s decision-making process (both at the registration and the assessment stage), as revealed by the evidence in this case. Engaging with that evidence shows that the process adopted by the CQC expressly took account of how patients arrive at IP1 (speaking to both patients and Kelly Psychology staff, as well as reviewing the relevant documentation). Ultimately, the question for the CQC was whether IP1 could demonstrate compliance with the requirements of the 2014 Regulations; the process it adopted in answering that question demonstrated a clear appreciation of the context, which included the fact that referrals came from an entity that the CQC did not itself regulate. This objection is not made out on the facts.

Referrals to IP1 from an entity that provides only non-medical psychological treatment. In this respect, the claimants rely on the fact that within the NHS referrals of 16 and 17 year olds for the hormone treatment are only permitted from entities that provide specialist secondary medical care, whereas such patients can be referred to IP1 by Kelly Psychology without having been seen by a medical professional. The claimants say this is a material consideration as it means that wider, specialist medical knowledge and expertise can be brought to bear on NHS referral decisions in circumstances where there may be co-morbidities, such as autism, anxiety, depression, eating disorders, or other mental health needs (rates of which, as the Cass Review recognised, are much greater in this cohort of vulnerable children than their peers).

The distinction identified in this regard does not directly arise from the NHS referral process for the hormone treatment but from the requirement that the prior referrals to its children and young persons gender services may only be made by NHS paediatric services or NHS mental health services for children and young people. This was the point made in the NHS England announcement of 7 August 2024; it is a requirement that came into effect as from 1 September 2024, albeit that the lengthy waiting list for such services in the NHS means that existing patients will have continued to be seen absent such a referral from a specialist service. In any event, it is not in dispute that the same restriction on referrals to Kelly Psychology (the direct comparison relevant to this point) does not exist. Again, however, it is apparent from the evidence that this was something of which the relevant decision-takers within the CQC were well aware.

Although the NHS referral pathway announced on 7 August 2024 was not in force at the time of the registration decision, it was one of the documents to which Ms Huntley expressly had regard when carrying out the subsequent assessment of IP1; it was also a matter which Ms Kirton de Ortega had in mind when she reviewed that assessment. In this regard, the CQC’s evidence makes clear that, having had regard to the structure of the service provided by the NHS (but also being aware of the different environment in which the NHS operates), the support provided to patients was a specific point of concern addressed through the assessment. Relevantly, although Kelly Psychology was not the subject of the CQC assessment, evidence was obtained about the process at that stage, which would include consideration of any potential referral by Kelly Psychology’s own MDT, subject to the patient meeting inclusion/exclusion criteria mirroring those of the NHS 21 March 2024 policy, with other (psycho-social) treatment options also being available, and with mental health and other support. Then following the process through, and considering cases that had been referred to IP1, regard was had to the mental health and other support available to patients at that stage, with a mental health nurse (who attended every initial face to face appointment) being one of those interviewed by Ms Huntley. Further consideration was given as to how IP1 continued to engage with others involved in the care of an individual patient, which was found to include information sharing with GPs, with a view to entering into shared care plans. The evidence thus demonstrates a detailed engagement with this point when holistically assessing the process of referrals to IP1; again, the objection raised by the claimants in this regard, is not made out on the facts.

IP1 is inextricably intertwined with Kelly Psychology; both entities operate “for profit”, and there is a risk that decision-making will be influenced by considerations of mutual benefit. In this regard, the claimants rely on the fact that IP1 and Kelly Psychology were both founded, and are both owned and operated, by Dr Kelly; that the two entities have the same registered address and are portrayed as an integrated service, with one booking process; and that some staff are employed by both organisations and their employees are often involved in joint presentations. The claimants say this inevitably gives rise to a risk of a conflict of interest, which will not exist in the NHS where there is no such interconnectedness.

Considering this issue under the heading of process irrationality, it is again apparent that the points being made were very much in the minds of those undertaking the relevant assessments. The CQC regulates thousands of private organisations operating in the health and social care sectors; it does not impose conditions in respect of the business models operated by such private businesses, nor does it seek to control the commercial arrangements they enter into. That does not mean, however, that the CQC does not have regard to the potential conflicts of interest that might arise when (as will generally be the case in the “for profit” independent sector) independent providers of TDDI services stand to benefit from any positive prescribing decisions they make. Even putting to one side the fact that individual clinicians will be bound by their own professional obligations and regulation, the CQC has explained that it will specifically have regard to the transparency of the processes operated by private sector providers, including clear prescribing criteria, and to evidence of adherence to those processes and to fundamental standards generally. In the present case, the evidence shows there was a clear focus on governance and on the safety of processes operated by IP1. The links between IP1 and Kelly Psychology were transparent at all stages, and made clear in the documents reviewed by the CQC. Equally, the integrated nature of the service was apparent from the documentation considered both at the registration stage and in the later assessment of IP1. The evidence demonstrates that due account was given to this feature, and, adopting the more rigorous examination required, I am satisfied that there is no gap in the CQC’s reasoning in this regard; this objection also fails.

There are clear differences between IP1’s MDT and the NHS national MDT. This issue was the primary focus of the claimants’ argument at the hearing, with the point being made that, while the CQC had reasoned that IP1’s MDT was “sufficiently aligned” with the NHS in this regard, the only basis for that conclusion was the presence of a single child psychiatrist, Dr Adams, who was not part of the referring team of clinicians. That, the claimants contend, revealed a failure to make reasonable enquiries into the NHS position and/or omitted to take into account a number of clear differences between the NHS national MDT and that of IP1. Specifically, the claimants say the NHS national MDT chair does not stand to benefit from any decision to approve treatment, whereas the chair of IP1’s MDT is paid by IP1 and cannot be said to be fully independent; all members of the IP1 MDT are employed and/or paid by either IP1 or Kelly Psychology, whereas there is no one on the NHS national MDT who works in a service providing the hormone treatment; moreover, IP1 MDT decisions are made by consensus and Dr Adams is but one individual, with all others being employees of Kelly Psychology or IP1, so it was unrealistic to consider she could provide a meaningful check; yet further, Dr Adams represents only one discipline, whereas the national NHS MDT is comprised of members from multiple specialisms and there is also a multi-disciplinary holistic assessment by the NHS gender service prior to any referral (consistent with the new model proposed by the Cass Review).

During the course of oral submissions, it was apparent that there was a disagreement between the parties as to whether, by considering IP1’s processes by reference to the NHS 21 March 2024 policy, the CQC had (at least in reaching its assessment decision) properly had regard to the way in which the NHS service was now structured. In this respect, the claimants placed particular reliance on the content of the letter from Evelina London, explaining how relevant services within the NHS currently operate. This was, however, obtained only shortly before the hearing and it was apparent that the claimants’ interpretation of that letter – and, therefore, description of how NHS services operate – was not agreed. This is not a dispute that I can resolve at this stage, but, in any event, I am satisfied it is unnecessary to do so. The CQC was concerned with whether IP1 could demonstrate compliance with the requirements of the 2014 Regulations; as such, while it saw NHS standards as highly relevant, it did not (and could not) treat those as determinative of questions of compliance by a private sector provider. It has not been suggested that the 21 March 2024 policy had been superseded by a later public statement of policy, or that there was clear NHS guidance as to what was meant by “extreme caution” (as per recommendation 8 of the Cass Review), to which the CQC ought, but failed, to have regard when reaching its assessment decision, (it plainly could not have done so when reaching the registration decision made in January 2024). In any event, the real issue must be whether proper regard was had to the reasons underlying the structures adopted in the NHS following the Cass Review; that is, does the evidence as to the assessment carried out by the CQC demonstrate that, as a matter of substance and not merely of form, account was taken of the risks that NHS safeguards were designed to address?

In approaching this question, it is again apparent that many of the points identified by the claimants are inherent in the fact that IP1 is a private provider that does not have access to the structures operated by the NHS. Inevitably, IP1’s MDT is principally comprised of those who are employed by it, or by Kelly Psychology, and the one person who does not fall into these categories (Dr Adams) is paid by IP1 on a contract basis. Equally inevitably, IP1 does not have access to the NHS national MDT, nor would it be able to precisely replicate that entity. These are matters that were, however, obvious to Ms Huntley and her colleagues: the CQC regulates both NHS and private sector providers and is aware of the structural differences that exist between a national, non-profit making, publicly funded, general health service, and a small, specialist, independent provider which is privately financed; I would not infer that a failure to expressly set out these points means they were not taken into account.

What is, moreover, clearly apparent from the CQC’s evidence is the detailed scrutiny that was undertaken in order to be able to assess IP1’s compliance with the regulatory requirements. Having carefully reviewed the evidence of Ms Huntley and her fellow assessors, it is apparent that this was an assessment that drilled down to the detail of the service provided by IP1, with patient safety foremost in mind. I have already summarised the work undertaken by those carrying out the assessment and am clear that careful regard was had both to the eligibility and readiness criteria set out within the 21 March 2024 policy, and to the reasons for those criteria. Thus, in considering the NHS requirement for the national MDT to include “clinicians not directly involved in the formulation of the individual’s care plan”, Ms Huntley took into account that this was to “ensure that the individual understands that there is limited clinical evidence on the effects and harms of [the hormone treatment] ... which is a significant decision with long term indications.” (see Ms Huntley’s statement at paragraph 35). In then assessing IP1 against that standard, Ms Huntley not only looked at the structure that it had put in place, but sat in on MDT discussions and formed an independent view as to the role played by Dr Adams as a member of that body who had no involvement in the patient’s care and who stood neither to lose or gain as a result of any decision reached on the referral. Other than the structural differences inherent in the comparison between the NHS and a small private provider, the evidence does not support the criticisms made under this point of challenge and the objection again fails.

IP1 and Kelly Psychology advocate for the hormone treatment. In this regard, the claimants rely on various comments made by/attributed to Dr Kelly and (to a lesser extent) others connected to IP1 and/or Kelly Psychology. The CQC accepts that it did not have these various citations in mind when reaching its registration and assessment decisions (indeed, the comments in question post-dated the registration decision), although it did undertake a check with earlier records relating to Tavistock GIDS (where both Dr Kelly and Mr Carruthers had previously worked), which revealed no issues relating to any of the individuals involved with IP1.

In approaching this point, I bear in mind the concerns expressed by the Cass Review as to the polarised views held by many clinicians as to the appropriate treatment of children presenting with gender incongruence and dysmorphia, and as to how this can impact upon clinical decision-making. This provides relevant context to the claimants’ contention as to how the strong views attributed to Dr Kelly might be potentially material to the decisions the CQC had to take (although, for completeness, I should say that I am unable to see that the citations relied on in relation to Mr Carruthers (a description by a third party which is insufficiently precise to have any real meaning) or Dr Quinney (a one-off social media comment dating back to 2019) assist the claimants’ argument in this respect). Had the CQC tracked down these various statements, however, it seems likely that Dr Kelly would also have directed it to the various academic articles and conference papers, which he says make clear that his views are more nuanced than newspaper comments might suggest.

Given that the CQC was required to reach its own conclusion as to IP1’s compliance with the requirements of the 2014 Regulations, it seems to me that, in respect of the decisions in issue, it legitimately limited its research to that which might be available from past records (specifically, past reviews of Tavistock GIDS), whilst forming its own view as to the suitability of those involved in IP1’s provision of the regulated service, as derived from the very full assessments undertaken, which included interviews with each of the relevant individuals. In the circumstances, I do not find the claimants have demonstrated that the “advocacy” evidence relied on is such as to have been so obviously material to the CQC’s decisions that its failure to find and take this into account reveals an irrationality in its process or reasoning. On the contrary, I am satisfied the steps taken by the CQC were rationally focused on scrutinising the actual process by which IP1 provided the service in issue. I duly reject this objection.

Process irrationality: an overview. Having considered each of the factors identified by the claimants individually, I have then sought to stand back to consider the approach adopted by the CQC, and its process of reasoning, taken overall. Acknowledging that the standards applied in the NHS are relevant to the assessments the CQC undertakes of the private sector provision of TDDI services by healthcare professionals, the question is whether it properly had regard to the particular, and changing, approach adopted by the NHS at the relevant time. Although many of the criticisms now relied on by the claimants are of little relevance to the registration decision – which was taken at a time prior to the key changes in NHS policy relied on - by the time of the assessment decision there had been a very real change in how the NHS approached the treatment of under 18s presenting with issues of gender incongruence and dysmorphia. It is the claimants’ case that the assessment undertaken by the CQC, subjected to the required standard of anxious scrutiny, fails to demonstrate a rational engagement with the considerations identified by the Cass Review, which form the basis for the policy that now underpins NHS services; it is their contention that this reveals a critical gap in the CQC’s approach to the discharge of its primary objective, to promote the health and safety of those who use health services.

Having duly carried out a rigorous examination of the relevant decision-making processes in this case, however, I have reached the conclusion that the claims made are focused on issues of form rather than substance. Most of the criticisms the claimants have identified relate to the structural differences inherent in the private provision of an independent, specialised, TDDI service as compared to the way in which a similar service will (and can) be provided by a national, publicly funded, entity of the size and scale of the NHS. Simply identifying those differences says little as to the rationality of the process adopted by the CQC in reaching the decisions in issue in these proceedings. That requires engagement with the detail of the evidence as to the actual assessments carried out, something that is largely absent from the claimants’ case. Having regard to that evidence, however, I am satisfied that this reveals a full and proper consideration of all relevant considerations, not simply ticking the boxes, but undertaking a thorough appraisal of each aspect of the service provided by IP1. The assessment process replicated each of the questions identified under regulation 12 of the 2014 Regulations. In then assessing IP1 in the light of those questions, the CQC undertook a detailed consideration of the documentary records, alongside interviews with patients and with those involved in the provision of the service at each stage (including employees of Kelly Psychology, notwithstanding it was itself not subject to CQC regulation); interviews were also undertaken with Dr Kelly and Mr Carruthers, and assessors sat in on patient consultations and on IP1 MDT decision-making discussions. Little issue has been taken with any of this evidence, but it is the answer to this ground of challenge: the decision-takers within the CQC had proper regard both to the relevant regulatory requirements and to each of the points of concern identified by the claimants; a detailed process of assessment was undertaken that fully engaged with those (and other relevant) concerns, considered through the prism of the requirements of the 2014 Regulations. The challenge on the basis of process irrationality duly fails.