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

Facts

The claimants — Bayswater Support Group, a company limited by guarantee representing some 800 parents and guardians of children who identify as trans or non-binary, Keira Bell, who has personal experience of treatment for gender dysphoria and who previously brought R (Bell) v Tavistock and Portman NHS Foundation Trust, and James Esses, a psychotherapist — challenged decisions of the Health Research Authority and the Medicines and Healthcare Products Regulatory Agency approving the PATHWAYS Trial, a clinical trial of puberty suppressing hormones for children and young people with gender incongruence, co-sponsored by King's College London and the South London and Maudsley NHS Foundation Trust. The Trial was commissioned by NHS England and the Secretary of State in response to the Cass Review's finding that the evidence base for such treatment was very weak, and was funded by the National Institute for Health and Care Research after eight peer reviews. Approvals were given in November 2025 by the MHRA and by a Research Ethics Committee. Following correspondence from sceptical clinicians and NHS England's pause on masculinising and feminising hormone prescribing, the co-sponsors sought modification of the protocol, which both regulators approved in June 2026. The claim, filed in February 2026, came before the Administrative Court for a two-day hearing on permission and interim relief, the preparatory stages of the Trial being due to begin on 1 August 2026.

Decision

Issues

• Whether the ouster clause in regulation 322 of the Human Medicines Regulations 2012 and the standing of the second and third claimants barred the claim.
• Whether the MHRA and the Research Ethics Committee failed to take account of mandatory considerations, in particular the destination therapy issue and the direct-benefit and risk/benefit conditions.
• Whether the HRA acted irrationally in withholding third-party representations from the Committee.
• Whether the Committee's process was insufficiently transparent.
• Whether the approvals were irrational and whether reasons were required.
• Whether the balance of convenience favoured interim relief.

Reasoning

Mr Justice Chamberlain rejected both in limine objections. On standing, he applied R (Luton Landlord and Letting Agents Ltd) v Luton Borough Council, holding that neither the second nor third claimant obviously fell within the category of the meddlesome busybody excluded by section 31(3) of the Senior Courts Act 1981; and, although Mr Milford for the MHRA relied on R v Medicines Commission ex p. Organon Laboratories Ltd, the judge accepted Mr Henderson's submission that it was arguable, given Anisminic Ltd v Foreign Compensation Commission and R (Privacy International) v Investigatory Powers Tribunal, that the ouster in regulation 322 of the Human Medicines Regulations 2012 did not exclude review at the instance of a person not given notice. The grounds nevertheless failed. Emphasising that Parliament's allocation of regulatory functions to scientifically expert bodies must be respected, and citing R (Mott) v Environment Agency and R (Justice for Health Ltd) v Secretary of State for Health, the judge held that the court must be very cautious before finding a specialist regulator's conclusion perverse, and that this caution applied equally to the Committee notwithstanding its mixed lay and expert composition. The destination therapy issue had plainly been recognised and weighed by the MHRA, which understood the CHM's role as advisory only; nothing in regulation 22C(6) of the Medicines for Human Use (Clinical Trials) Regulations 2004 obliged rejection. Mr McCullough's unpleaded contention that Schedule 1, Part 4, condition 10 of the Medicines for Human Use (Clinical Trials) Regulations 2004 and principle 28 of the Declaration of Helsinki required proof that benefit was more likely than not was refused as unpleaded and rejected on its merits: a reasonable prospect of benefit sufficed, and, as Cream Holdings Ltd v Banerjee shows, "likely" does not invariably mean more probable than not. Third-party comments were not among the matters listed in regulation 15(5) of the Medicines for Human Use (Clinical Trials) Regulations 2004, so, applying R (Friends of the Earth Ltd) v Heathrow Airport Ltd and R (Balajigari) v Secretary of State for the Home Department, their exclusion was reviewable only for irrationality and was fully explained. On transparency, an adequate summary had been published and no useful relief would follow. Applying R v Secretary of State for the Home Department ex p. Doody and Dover District Council v CPRE Kent, no common law duty to give reasons to the public arose. On interim relief, applying American Cyanamid Co v Ethicon Ltd as modified for public law and R (FTDI Holding Ltd) v Chancellor of the Duchy of Lancaster, delay of at least five months, the risk of participants self-medicating and of aging out, and the weight given to public health in R v Secretary of State for Health ex p Eastside Cheese Co decisively outweighed the limited harm in the converse scenario.

Case history