The decisions under challenge and the issues for determination
The decisions under challenge and the issues for determination
The claimants’ amended case essentially challenges three decisions by the CQC: (1) a decision of 9 January 2024, to register IP1 as a provider of a regulated activity, namely treatment for a disease, disorder or injury (“TDDI”) by a healthcare professional (“the registration decision”); (2) a decision of 3 December 2024, to rate IP1 as “outstanding” overall, and “good” for safety following an assessment, and thus continue its registration (“the assessment decision”); and (3) what is characterised as a failure to impose a condition on IP1’s registration “akin to the requirement for a second opinion from independent and impartial persons which is required in equivalent circumstances for safety reasons on the NHS” (“the condition decision”).
The claimants put their case under three heads: (1) process irrationality; (2) outcome irrationality; (3) breach of the Padfield principle (Padfield v Minister of Agriculture and Fisheries [1968] AC 997). By the claimants’ re-amended grounds, this case is advanced in reliance on the following five points:
referrals of 16-17 year olds for the hormone treatment on the NHS may only be made by entities regulated by the CQC, which is not the position with IP1, where referrals are made by Kelly Psychology Ltd (“Kelly Psychology”), which is not regulated by the CQC;
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;
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;
the NHS national multi-disciplinary team (“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;
individuals who staff or run IP1 and Kelly Psychology have made public statements relevant to the question of registration/continued registration and/or demonstrate that they advocate for the hormone treatment.
The claimants contend that (1) the failure to reasonably enquire into, and/or take into account, these matters give rise to process irrationality; alternatively, (2) having regard to these matters, the CQC’s decisions were irrational in outcome; alternatively, (3) that the CQC’s decisions frustrate the policy and objects of the relevant legislative regime.
- Heading
- This judgment was handed down by the Judge remotely by circulation to the parties' representatives by email and release to The National Archives. The date and time for hand down is deemed to be 2pm on
- Mrs Justice Eady DBE
- Preliminary issue
- The decisions under challenge and the issues for determination
- The factual background
- The context
- The chronology relevant to the decisions under challenge and the current proceedings
- The registration decision
- The assessment decision
- IP1 patient data
- Advocacy
- O v P
- The statutory framework
- Regulated activity
- Registration of persons who carry on regulated activity
- Reviews and performance assessments
- Fundamental standards
- Statutory guidance for registered persons
- Relevant legal principles
- Process rationality
- Outcome rationality
- The Padfield principle
- The parties’ arguments
- The position of the CQC
- IP1’s position
- Analysis and conclusions
- Process irrationality
- Outcome irrationality
- The Padfield challenge
- Conclusions
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