Susan Evans & Anor, R (on the application of) v Care Quality Commission & Ors

Judicial review of an expert healthcare regulator requires scrutiny calibrated to the importance of the interests affected, but the court must still respect the regulator’s evaluative expertise. A process irrationality challenge requires direct consideration of mandatory relevant considerations, engagement with relevant evidence, and reasoning without logical error or critical gap.

Outcome irrationality requires the decision to fall outside the range of reasonable decisions open to the regulator. NHS standards may provide a relevant comparator for a private provider, but the statutory scheme does not require procedural equivalence or replication of NHS structures. The regulator may assess whether the private provider meets the underlying safety objectives through different arrangements.

The claimants challenged decisions of the Care Quality Commission concerning the registration and subsequent assessment of Gender Plus Healthcare Limited, a private provider of hormone treatment to some 16 and 17 year olds experiencing gender dysphoria.

The challenges concerned the January 2024 registration decision, the December 2024 assessment and continuation of registration, and the failure to impose an additional condition. The claimants relied on process irrationality, outcome irrationality and the Padfield principle. They identified differences between the private provider and NHS safeguards, including referral arrangements, institutional separation, multidisciplinary team structures and alleged advocacy for the treatment.

The central issues were whether the CQC had properly considered those matters, whether its conclusions fell outside the rational range, and whether the statutory regime required private provision to replicate NHS procedures.

1. The claim was dismissed. The CQC’s registration, assessment and decision not to impose further conditions were lawful.
2. A heightened standard of review was appropriate because the decisions concerned serious, life-changing treatment sought by vulnerable 16 and 17 year olds. That did not remove the need for caution before overturning the evaluative judgments of an expert regulator. The CQC’s regulatory expertise remained relevant even where its inspectors lacked a specific sector specialism.
3. For process irrationality, the CQC had to consider mandatory relevant considerations, grapple with relevant evidence and provide reasoning without a logical error or critical gap. The evidence showed that it had considered the referral arrangements, the relationship between IP1 and Kelly Psychology, the multidisciplinary team structures, the NHS comparator and the relevant professional conduct issues.
4. For outcome irrationality, the question was whether the decisions fell outside the range of reasonable responses open to the CQC. The CQC was concerned with compliance by IP1 with the Health and Social Care Act 2008 and the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. NHS standards were highly relevant, but they were not determinative.
5. The statutory scheme did not require a private provider to reproduce the NHS national multidisciplinary team or achieve procedural equivalence with the NHS. The relevant comparison was with the substance and objectives of the NHS safeguards, including caution, informed decision-making and attention to the limited evidence base. The CQC was entitled to conclude that IP1’s arrangements were sufficiently aligned with those objectives.
6. The patient data did not provide a proper comparison with NHS referrals and could not determine the legality of the CQC’s decisions. The CQC was not required to audit each individual clinical decision, which remained within the expertise of clinicians and their professional regulators.
7. The Padfield argument added nothing. The evidence did not show that the CQC had frustrated the purpose of the statutory regime.