Bayswater Support Group & Ors, R (on the application of) v Health Research Authority & Anor

Judicial review is not an appeal on the merits. Where Parliament entrusts a technical or ethical regulatory function to a specialist body able to ask probing questions, obtain advice and decide iteratively, the court must exercise particular caution before finding irrationality. This applies to a mixed expert-and-lay research ethics committee as well as a scientific regulator. In a clinical trial involving minors, a requirement for some direct benefit to the group does not require a prediction that benefit is more likely than not for a greater-than-de-minimis proportion. A reasonable prospect of benefit for each participant may suffice, and benefit–risk assessment is a matter of clinical judgment. Third-party material is not automatically a mandatory consideration, and a common-law duty to give reasons is not generally implied where the statutory scheme specifies when reasons are required. Permission was refused and interim relief would in any event have been refused.

The claimants sought permission to challenge decisions by the Health Research Authority and the Medicines and Healthcare products Regulatory Agency approving, and later approving a modified protocol for, the PATHWAYS clinical trial involving puberty suppressing hormones for children and young people with gender incongruence. King’s College London and South London and Maudsley NHS Foundation Trust were interested parties.

The challenge concerned the destination-therapy issue, the statutory benefit and risk requirements for trials involving minors, third-party representations, transparency, the rationality of the trial design, and reasons for the approvals. The claimants also sought interim relief preventing the preparatory stages of the trial from commencing.

The court considered permission and interim relief at first instance. The central issues were whether any pleaded ground had a realistic prospect of success and, if so, whether the balance of convenience favoured interim relief.

Permission

1. Judicial review. The court must respect the legislative allocation of regulatory functions and must not substitute its own merits assessment. Particular caution is required when reviewing technical or scientific decisions by a regulator with relevant expertise, experience, probing powers and an iterative process. The same caution applied to the mixed expert-and-lay research ethics committee. The court relied on R (Mott) v Environment Agency [2016] EWCA Civ 564 and R (Justice for Health Ltd) v Secretary of State for Health [2016] EWHC 2338 (Admin).
2. Grounds 1 and 4. The MHRA had treated future access to masculinising and feminising hormones as a critical issue. It had not assumed that such access would necessarily be available, but had assessed the uncertainty as part of the benefit–risk judgment. Advice from the Clinical Trials, Biologicals and Vaccines Expert Advisory Group remained advisory; the approval function belonged to the MHRA. The REC had also considered the issue. The statutory requirement for some direct benefit to the group did not impose a more-likely-than-not test. A reasonable prospect of benefit for each carefully selected participant could satisfy it. Benefit–risk assessment was a complex clinical judgment. The trial was a valid pragmatic trial capable of assessing benefit, harm or no material difference across defined domains.
3. Grounds 2, 3 and 5. Third-party comments were not automatically mandatory considerations under the statutory list of matters for the REC. The decisions about placing material before the REC were rational. The November transparency complaint could not usefully lead to quashing, and the June decision had been taken only six weeks earlier without a statutory publication deadline. The statutory scheme imposed reasons duties for certain refusals, but not for approvals. No generally applicable common-law duty arose, and the reasons issue was in any event academic.
4. Permission and interim relief. None of the five grounds was arguable with a realistic prospect of success, so permission was refused. Interim relief therefore did not arise. Alternatively, applying the principles in American Cyanamid Co. v Ethicon Ltd [1975] AC 396, the balance decisively favoured allowing the specialist regulators’ decisions to operate. Delay would harm the public interest and prospective participants, whereas monitoring and eligibility safeguards limited the potential countervailing harm.

The application for permission to apply for judicial review was refused. Interim relief was refused in the alternative.