We have previously reported on litigation over the use of puberty blockers and and on the Orders made by the Secretary of State to restrict the prescription of puberty blockers.
In R. (on the application of Bayswater Support Group) v Health Research Authority and others [2026] EWHC 2043 (Admin), Mr Justice Chamberlain has just ruled on a legal challenge to a clinical trial that was due to begin shortly.
Factual background
Until recently, the treatment given by the NHS for children and young people presenting with gender incongruence and gender dysphoria was provided by the Tavistock and Portman NHS Trust’s Gender Identity Development Service (“GIDS”).
In 2022, the interim report of the Cass Review made criticisms of the treatment provided by GIDS and recommended that new regional gender services centres should be established. Later that year, she recommended “the rapid establishment of the necessary research infrastructure to prospectively enrol young people being considered for hormone treatment into a formal research programme with adequate follow up into adulthood, with a more immediate focus on the questions regarding puberty blockers”. She continued:
“Without an established research strategy and infrastructure, the outstanding questions will remain unanswered and the evidence gap will continue to be filled with polarised opinion and conjecture, which does little to help the children and young people, and their families and carers, who need support and information on which to make decisions”.
The final report of the Cass Review was published in April 2024. It reiterated these recommendations.
As we have previously reported, the then Secretary of State for Health and Social Care imposed a pause on new prescriptions for masculinising and feminising (“MAF”) hormones for young people.
In November 2025 and June 2026, the Health Research Authority (“HRA”) and the Medicines and Healthcare products Regulatory Agency (“MHRA”) approved a clinical trial of gonadotropin-releasing hormone analogues (also known as puberty suppressing hormones or “PSH”) for the treatment of gender incongruence in children and young people, called the PATHWAYS Trial (“the Trial”). It is co-sponsored by King’s College London (“KCL”) and the South London and Maudsley NHS Foundation Trust (“SLAM”), who were interested parties.
Application to apply for permission to apply for judicial review
The Claimants applied for permission to seek judicial review of the decisions to approve the clinical trial and for an order preventing the commencement of the clinical trial pending the outcome of a judicial review hearing.
Between them, the parties filed material including 31 witness statements, detailed written submissions and authorities. The documentation ran to over 13,000 pages. The hearing lasted two days (which is unusual for a hearing to decide whether a claimant has an arguable case).
Judgment
The judge held that none of the Claimants’ grounds of challenge had a realistic prospect of success. Permission to apply for judicial review was refused. Amongst other things, he said:
- The Trial was commissioned by NHS England and designed by its co-sponsors with conspicuous care, in consultation with other expert bodies. The participants will be children with persistent gender incongruence who are receiving treatment from specialist gender services. Each child will have been assessed over many months by specialist doctors. In each case, the treating team will have formed the opinion that the child has a reasonable prospect of receiving a clinical benefit from the treatment. There is a detailed process to ensure that the child assents and a parent consents to the treatment, having been fully informed of what it involves and of its potential outcomes. A second opinion will be obtained from a National Multi-Disciplinary Team (“NMDT”) of paediatric and other specialists to ensure that participation is clinically appropriate in the individual case.
- UK law requires clinical trials to be approved by two specialist bodies. The MHRA is responsible for the safety of the clinical trial and the safeguarding of participants. It undertook a rigorous process to assess the trial before giving its initial approval in November 2025. It later took on board concerns raised by a group of sceptical clinicians and considered the impact of an intervening decision by NHS England to pause prescriptions of MAF hormones for young people. It asked a series of questions of the trial co-sponsors before concluding in June 2026 that the Trial could proceed with a modified protocol. The HRA was required to and did refer the question of ethical approval to a Research Ethics Committee (“REC”) including both experts and lay people. The REC gave that approval in November and, having reconsidered the position in the light of subsequent developments, affirmed its approval of the modified protocol in June 2026.
- In its June 2026 decision, the MHRA properly recognised that the likelihood that trial participants would have access to PSH and/or MAF hormones after their participation in the trial came to an end (“the destination therapy issue”) was critical to its decision. Its conclusion, taking account of that issue, was rational. The MHRA rationally concluded that “[s]ome direct benefit for the group of patients involved in the clinical trial is to be obtained from that trial”. The HRA’s research ethics committee (“REC”) did not fail to take account of any of the relevant matters identified by the claimants.
- The HRA was not required by the regulatory regime to place third-party comments before the REC.
- The design and purpose of the Trial were fully explained in the application materials. The suggestion that the Trial lacked a valid testable hypothesis is based on a misunderstanding of its purpose: it was a pragmatic trial designed to assess the benefits and risks of PSH. Whether to approve a trial with this purpose was quintessentially a question of judgment for the MHRA and HRA.