The government is aware of the potential irreversible impact (physical and emotional) of puberty blockers, having acknowledged an 'unacceptable safety risk’ following the Cass Review. Yet, hundreds of children are about to be given puberty blockers under a government-sanctioned trial.
We want this trial to be cancelled. We believe that the answer for children feeling dis-ease in their bodies (many of whom are autistic) is the passage of time and natural progression of puberty, coupled with explorative therapy. We believe that the answer is never medicalisation that can harm brain development, bone growth, sexual functioning, and lead to infertility, and that to put children on a path towards such harm is the antithesis of safeguarding.
Let us not be written into history as the country that knowingly harmed vulnerable children.
Monday 2nd February 2026
We are following the expert advice of the Cass Review to establish a clinical trial to determine the relative benefits and harms of puberty suppression in young people with gender incongruence.
It is essential for the Government and the NHS to be guided by expert clinical advice and act with caution and care when it comes to supporting children and young people living with gender incongruence. The independent Cass Review concluded that the rationale for early puberty suppression remains unclear, and that there is not enough clinical evidence for the safe and effective routine use of puberty suppressing hormones to treat gender incongruence in under-18s. For that reason, this Government supported and extended indefinitely the ban on their use outside of research. Despite these restrictions, some young people are going to great lengths to source these drugs from unregulated providers, in the absence of scientific evidence.
The Cass Review recommended that a programme of research be established to underpin the design and delivery of NHS gender care. It specifically recommended this include a clinical trial into puberty suppression in young people with gender incongruence. This recommendation addresses the lack of evidence about the relative benefits and harms of this treatment option, particularly when provided alongside an updated model of NHS care incorporating holistic assessment and a comprehensive and tailored package of psychosocial support.
The study protocol is available on the National Institute for Health and Care Research (NIHR) website: https://fundingawards.nihr.ac.uk/award/NIHR167530
The bar for a UK clinical trial to be approved is extremely high, with the PATHWAYS trial going through rigorous rounds of scientific, clinical, ethical and regulatory review. It was approved by an independent NIHR funding committee. The final protocol was subject to rigorous approval processes through both the Medicines and Healthcare products Regulatory Agency and the Health Research Authority – including review by an independent Research Ethics Committee.
The Commission on Human Medicines also considered information on the trial in detail and made recommendations that were considered and adopted by the study team. With the strongest safeguards possible, a trial of this kind is the only way to build a sufficiently high-quality evidence base to inform decisions on the future use of this treatment option for this vulnerable and distressed group of young people.
Protecting and promoting the health and wellbeing of affected young people is the primary concern and there are strict eligibility criteria in place to join the PATHWAYS clinical trial. Parental consent is an integral component, with the parent needing to not only agree to their child’s involvement but also demonstrate sufficient understanding of the nature of the treatment, and what is currently known and unknown about its effects. Informed assent from the child will also be required. This will include the young person explaining in their own words to the clinician what the risks are and what they understand by those risks.
The only children to get to that stage will have already been diagnosed with gender incongruence for at least two years, will have received tailored psychosocial support, and will have been deemed clinically appropriate, within the context of the study, by both their NHS care team and the National Multi-Disciplinary Team. They will also have had to be assessed as being in stable physical and mental health.
Those young people receiving (or not receiving) puberty suppressing hormones will continue to receive other elements of routine support and treatment provided as part of newly established NHS Children and Young People’s Gender Services, whose practices have been shaped by the recommendations of the Cass Review. Participants can leave the trial at any time, at which point they would receive support in their withdrawal from puberty suppression as well as ongoing psychosocial support from NHS services.
Healthcare must always be led by evidence. Puberty suppression has been provided in the past with insufficient evidence, and young people have been left to go without the support and care that they need. This Government is determined to change that, and it is only through evidence-based research that we can determine the most effective way to support these young people. We believe that children and young people with gender incongruence have the same right to participate in ethically-approved research, and to receive evidence-based care, as any other group of individuals seeking the support of the NHS.
Finally, it is important to reiterate that gender incongruence is an internationally recognised disorder. It is defined in the International Classification of Diseases 11th Revision as “a marked and persistent incongruence between an individual’s experienced gender and the assigned sex”. It does not describe girls and boys experimenting with gender norms, which for many children is a normal part of growing up. These important differences are properly understood and reflected in the new model of care being provided by the NHS.
Department of Health and Social Care