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![R (Bayswater Support Group, Keira Bell and James Esses) v (1) Health Research
Authority, (2) Secretary of State for Health and Social Care
Press Summary: For release at 2.10pm. 31 July 2026
This summary is provided by the Court for the assistance of those reporting the judgment (neutral citation [2026] EWHC 2043 (Admin)). It does not form part of that judgment.
Headline
Mr Justice Chamberlain has today rejected a challenge to regulatory decisions in relation to the PATHWAYS clinical trial for puberty suppressing hormones ("PSH").
Background
In 2020, NHS England commissioned the paediatrician Dr Hilary Cass (now Baroness Cass) to chair a review of gender identity services for children and young people. A central finding of what became known as the Cass Review was that the evidence base for the use of PSH in children and young people with gender incongruence was very weak.
NS England and the Secretary of State commissioned a clinical trial designed to address the "evidence gap" identified by the Cass Review: the Puberty Suppression and Transitional Healthcare with Adaptive Youth Service or "PATHWAYS Trial". The Trial was co-sponsored by King's College London and the South London and Maudsley NHS Foundation Trust. They are interested parties in this case.
4
The sponsors submitted an application for regulatory approval in August 2025. Approval was given in November 2025 by the Medicines and Health Regulatory Agency
("MHRA") on behalf of the Secretary of State and by the Health Research Authority
("HRA"). The Secretary of State and the HRA are the defendants in this case.
There were then two developments. A group of clinicians wrote to the regulatory authorities to express their concerns and the Secretary of State for Health and Social Care announced a pause on new prescriptions for masculinising and feminising ("MAF") hormones for young people.
6
The MHRA asked further questions of the co-sponsors with a view to considering whether to maintain the approvals. The co-spon…](https://cdn.bsky.app/img/feed_thumbnail/plain/did:plc:hssofozj73msacna445rbhcd/bafkreibczv2puexdbhfgf2wms6z6ssgfebjhsswghmzo3hb5lsd33gzqo4)
![question of ethical approval to a Research Ethics Committee ("REC") including both paediatric consultants 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.
(C)
Where regulatory functions have been conferred on a specialist regulator with technical or scientific expertise, it will generally be because the function is best performed by persons who have been trained in the scientific method. In assessing an application for approval in a context such as this, the specialist regulator can use its prior experience to spot gaps, ask probing questions and evaluate the responses.
If the regulator's decision is challenged on rationality grounds in judicial review proceedings, the court must be very cautious about interfering with that decision.
The Court's function is not to say whether it agrees with the decision under challenge, but rather to examine whether the defendants have exercised their functions contrary to the legislative scheme or otherwise unlawfully. These
principles apply to both regulators whose decisions are challenged here.
(d) The claimants advanced their challenge to the HRA's and MHRA's November 2025 and June 2026 decisions under five grounds. After careful examination, none of them is arguable with a realistic prospect of success:
(i)
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 any of the relevant matters identified by…](https://cdn.bsky.app/img/feed_thumbnail/plain/did:plc:hssofozj73msacna445rbhcd/bafkreig53uvh4kqwba2efgdspgkp4kfz6e2phfw7qjuzf4ydumsiskyzm4)
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Stated reasons for voting Green [Green 2026 voters only]
"You said you plan to vote Green at the local elections. Below are some reasons people have given us for voting Green. Please pick up to three
reasons closest to your own."
All Green LE2026 Lab 24→ Green 2026
Their policies and values are closest to my own 40% 37%
Their commitment to tackling climate change
and protecting the environment 32% 22%
They want to tax the rich and redistribute wealth 32% 33%
They are the only genuinely left-wing/
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They would take water, rail and other utilities
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To send a message against Reform UK and the
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work for the area 18% 18%
Their support for trans rights and other minorities 15% 15%
Zack Polanski is the best leader on offer 14% 14%
Their stance on Gaza and Palestine 12% 12%
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