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

It is the claimants’ case that the CQC cannot rationally (whether considered as a matter of process or outcome) have concluded that the process by which the hormone treatment is provided by IP1 is safe, which is what is required by regulation 12(1) of the 2014 Regulations; further/alternatively (albeit conceding in oral argument that this added little to the case on rationality), it is contended that the decisions reached by the CQC breach the Padfield principle, in that they frustrate, or run counter to, the policy and objects of HSCA and/or the 2014 Regulations (in particular, regulation 12).

In arguing that the higher standard of review applies to the irrationality challenge in this case, the claimants point out that that the hormone treatment is often sought by vulnerable and emotionally distressed individuals (here, children aged 16-17, with rates of autism spectrum disorder, anxiety, depression, eating disorders and other mental health needs “much greater ... than age matched peers”; the Cass Review final report [5.26]-[5.27]), and can have significant, irreversible, long-term physical and psychological consequences. It is, moreover, the claimants’ case that the claimed expertise of the CQC should not carry particularly strong weight with the court: this was a generalist regulator and the relevant assessments were carried out by individuals without relevant expertise (as compared, for example, to the Cass Review).

The claimants say that the statutory framework must be read with its primary purpose in mind, namely, to protect and promote the health, safety and welfare of people who use healthcare services. Within this context, they submit that regulation 12(1) of the 2014 Regulations requires the CQC itself to be satisfied (in accordance with public law principles) that the process by which the hormone treatment is provided must be safe. As the CQC recognised, relevant to that obligation were the standards applied within the NHS; in reaching its decisions, however, the CQC then failed to consider/take into account a number of aspects of the position within the NHS that were obviously material to its assessment of safety, alternatively (to the extent these were taken into account) meant that its conclusions were outside the reasonable range open to it (a point made good by the contrast in the numbers accepted for hormone treatment by IP1 and the position in the NHS).

Specifically: (1) while referrals of 16-17 year olds for the hormone treatment on the NHS may only be made by entities regulated by the CQC, that was not the position with IP1, where referrals are made by Kelly Psychology; (2) new referrals of 16-17 year olds to the NHS gender service are only permitted by NHS paediatric services or NHS mental health services for children and young people, which is not the position with Kelly Psychology or IP1; (3) within the NHS, there is institutional separation between the entities that make the referral and those that administer the hormones, which is not present in relation to referrals by Kelly Psychology to IP1; and (4) the NHS national MDT, which is required to approve the hormone treatment for any child on the NHS, has different features from the MDT which decides whether IP1 should accept a child for such treatment. The claimants further contend, (5) that an additional risk to safety arose from the strong positions advocated by Dr Kelly and others associated with IP1 and Kelly Psychology.