PARLIAMENTARY DEBATE
Pathways Study: Puberty Suppression - 22 June 2026 (Commons/Commons Chamber)
Debate Detail
I know what a sensitive, emotive and difficult issue this is. I myself have wrestled with, and at times struggled with, the profound challenges that this subject raises. In all of my consideration and deliberation over this matter, my bottom line has been to protect the safety and wellbeing of children and young people. The way to do that is to follow expert clinical advice and take an evidence-led approach, which is what this Government are doing. As adults, we all owe a duty of care to every child and young person in the country. It is a responsibility that I—both as a citizen and as Health Secretary—bear with the utmost seriousness and sincerity.
I do not believe that children’s safety and wellbeing was being adequately protected just a few years ago. I think it would be helpful to remind Members how we arrived at that point. For several years before the turn of the decade, the number of children and young people being referred for NHS support around their gender identity increased rapidly. Stories subsequently emerged of young people struggling after undergoing radical and permanent transition surgery at a young age, children being rushed into taking medication without adequate therapy beforehand, and clinicians disregarding conditions such as neurodiversity and mental health conditions. As such, there was rightly deep concern about the vulnerability of these children and young people, the care and treatment they were receiving and the surge in referrals.
In 2020, NHS England commissioned leading paediatrician Dr Hilary Cass to carry out a review of NHS gender identity services for under-18s. What Dr Cass uncovered was shocking and scandalous, and she made a series of recommendations for how children could be better protected and supported. I remind the House that those recommendations were accepted in full by both the Conservative Government of the time and my party in opposition.
It was, in my mind, clearly wrong for children and young people to be routinely prescribed puberty blockers for gender dysphoria without any clear evidence on their benefits or risks. The situation was out of control, and I fully supported the indefinite ban introduced by my predecessor, my right hon. Friend the Member for Ilford North (Wes Streeting), which followed the temporary ban brought in by the previous Government.
I do not think there is anyone with more respect as a clinician in this space than Dr Cass, and my predecessors in this role recognised that too. Dr Cass identified treatment for gender incongruence as
“an area of remarkably weak evidence”.
She found that even clinicians working in the field were divided on the best way to support, treat and care for young people suffering gender dysphoria. Where there is strong divergence of medical opinion on treatment, the two possible responses are to continue with the uncertainty—and, with that, conflicting opinions and advice—or to undertake a trial, not just to resolve a dispute but to make sure that children with gender-related distress get the same standards of care as everyone else in the NHS.
As Dr Cass has said, the vast majority of children and young people who question their gender will resolve it without needing any support other than that of their friends and family. For many young people, questioning their identity on many different fronts is a normal part of growing up, and we should simply let them be. For a small number of young people, though, greater support is needed because of the level and longevity of the discomfort that they feel. That can often involve counselling or therapy. For a very, very small number of young people, it is possible—I emphasise the word “possible”—that medical treatment would help to improve their quality of life and mental health, and reduce their gender-related distress.
That is why Dr Cass, whose approach until recently commanded cross-party consensus, recommended a trial to establish how best to support children and young people suffering gender incongruence. That is the Pathways study. It has four main parts, one of which is the clinical trial to study the effects of puberty-suppressing hormones on young people’s physical, social and emotional wellbeing. The Pathways trial, which is being led by King’s College London and the South London and Maudsley NHS foundation trust, was initially approved last November. The trial seeks to gain evidence on whether those potential benefits are real, alongside evidence on whether such treatment comes with the risk of harm.
It is right that this Government are guided by expert clinical advice and a clinical, evidence-led approach, but as this study involves children, and therefore comes with a particular responsibility, as Health Secretary I have sought the most detailed assurances possible from my clinical advisers about how children taking part in the trial will be protected. There are a number of important safeguards. Children can participate only with the consent of a parent or guardian, and the children themselves must consent or assent. They can participate only if they have had a diagnosis of gender incongruence for at least two years. They can participate only if they have received psychosocial support through the NHS. They can participate only if they are of stable physical and mental health. They can participate only if they are not subject to any safeguarding concerns. They can participate only if they and their parents demonstrate sufficient understanding of the nature of the treatment, including its potential advantages and disadvantages. They can participate only if they have been deemed clinically appropriate by both the NHS care team and the national multidisciplinary team, and they can participate only if they are already accessing NHS gender services. So, when it comes to eligibility, we are talking about a very small subset of a very small group. The number of young people who would expect to quality for the trial will be low, and the safeguards to ensure their safety and wellbeing are rigorous. I have sought and had reassurance that once participants are on the trial, they may be withdrawn at any point.
As hon. Members will know, the Medicines and Healthcare products Regulatory Agency raised new concerns at the beginning of this year, and the start of the trial was delayed so that they could be fully scrutinised. On Thursday last week, the regulators approved an updated protocol that significantly strengthened the objective criteria for withdrawing children from the trial. I welcome that change. Signs of greater risk to participants will now trigger increased monitoring, clinical review or automatic withdrawal from the trial. All participants will be monitored before, at the start of, every three months during and after the trial. Before and during the trial, information will be collected about mental health, quality of life, self-harm and suicidality, body image, cognition, puberty stage, physical health and side effects.
On bone health, puberty is normally a time of rapid bone gain, so if changes in bone density are identified, that will lead to a reassessment of whether the participant should continue in the trial, with set criteria for automatic withdrawal. On fertility, there is no published scientific evidence of irreversible changes, but that will be proactively addressed, with every participant offered repeated counselling and a range of options to preserve their fertility. On cognition, while there are no established scientific reports proving a cognitive effect, the new protocol sets out strict definitions for investigation and automatic withdrawal of young people from the trial.
The new criteria for increased monitoring or withdrawing children from the trial will mean that, at the first sign of negative impacts, action will be taken. These criteria will stop short-term harm, and the view of the National Institute for Health and Care Research is that that means any long-term harm should not occur or go unnoticed. Those reassurances about preventing harm to the children who take part in the trial, and taking clear action if any risks appear to increase, are critical. After considering the matter closely over the past few days, I have requested monthly updates on the progress of the trial, including on any emerging risks.
Pathways is rightly one of the most scrutinised UK clinical trials of recent times—we should expect nothing less when we are talking about the health and wellbeing of some of the most vulnerable children in our country. Yet, as Dr Cass has made clear, we have to build the evidence base to show whether the treatments are safe and whether they produce the positive outcomes that young people and their clinicians want from them. My view is that proceeding with the trial is, on balance, the most appropriate way forward.
This has not been easy—I am sure many hon. Members are also wrestling with this dilemma—and, as we debate this issue today, I hope that we will keep in mind Dr Cass’s ask to consider the issues sensitively and cautiously. As she said:
“Polarisation and stifling of debate do nothing to help the young people caught in the middle of a stormy social discourse, and in the long run will also hamper the research that is essential to finding the best way of supporting them to thrive.”
I will not pretend that I do not continue to feel discomfort and unease, but I believe that the only way for us all to come to a fair and settled conclusion on this matter—to move forward as a country on this difficult and sensitive issue—is on the basis of clinical evidence in which we trust. Thanks to the strengthened criteria now in place for monitoring children’s wellbeing and withdrawing them from the trial, there is now intense scrutiny, and there are robust mechanisms to prevent harm from coming to the young people who take part. It is on that basis that I believe we should follow the advice of clinical experts and seek the clinical evidence that will give us the confidence to know that where we settle on this matter in the future is right. I commend this statement to the House.
Let us look at this carefully. Gender incongruence is a subjective condition; it is how someone says they feel. There are no lab markers and no scans. That, of course, is not necessarily unusual. In fact, it is common in mental health conditions. Gender incongruence is often self-resolving; it gets better on its own. Again, this is not unusual in paediatrics. It is really common for children to be admitted to hospital for supported care for things like gastroenteritis and respiratory viruses. Puberty blockers are powerful drugs. This is a powerful treatment with significant long-term consequences. Again, this is not new to paediatrics. Some chemotherapy, for example, has substantial short and long-term consequences. But what is unusual and, I think, toxic is the combination of all three. Medicine is about balancing risk. Where else would we give powerful drugs with potentially serious long-term consequences for a subjective condition that is likely to get better on its own?
I understand that this trial has been approved, but time and again we have seen and heard how fear and hostility can distort priorities. We have seen tragedy occur when fears of accusations of racism limited mental health treatment. We have seen profound suffering when fear of accusations of Islamophobia limited inquiries into the grooming gangs. The healthcare of children distressed about their gender is another topic where there have been attempts to shut down debate with threats and accusations of transphobia.
Such attempts were reported in relation to the Tavistock.
When considering treatments for life, with lifelong implications, we have a duty to be careful and sensible, so I ask the Secretary of State: why are this Government funding a trial that will cause harm to physically healthy children? These children may be 11 years old, at Tanner stage 2. Some of them are primary school children with only minimal signs of puberty. This is far too young. The MHRA warned in February that the youngest patients are at greatest risk; they may end up on puberty blockers for a much longer period, and face a higher risk to fertility, because sperm and eggs have not yet fully developed at Tanner stage 2.
I am reminded of this point in the judgment in Bell v. Tavistock:
“There is no age appropriate way to explain to many of these children what losing their fertility or full sexual function may mean to them in later years.”
Yet as the Secretary of State confirmed, the children must consent or assent to being in the trial. Why did the Government not heed the MHRA’s recommendation of a minimum age of 14 years? This Labour Government think that 14 is too young to watch social media. Why do they think 11 is old enough for this trial?
What is the goal of the treatment? In the trial, the outcome is a short to medium-term effect on quality of life and body satisfaction. Does the Secretary of State believe this is proportionate to the risks of these medications? Is there any evidence suggesting that puberty blockers are safer than they were thought to be in 2024, when the Government banned them, following the expert advice from the Commission on Human Medicines? Some have suggested that the drugs help adults to pass as the opposite sex. Is the long-term damage really worth it for the cosmetic benefit of a few? And it is just a few, because we know that the vast majority will be better without any treatment.
The Secretary of State said that “when it comes to eligibility, we are talking about a very small subset of a very small group.” Even if we were to accept the premise that a very small number might benefit from treatment, how could the clinicians identify which those children might be? A study of clinical outcomes from kids treated at the Tavistock is due to be completed next year. That could help, so why is the Secretary of State not waiting until that report is completed before conducting an experiment on an unnecessarily broad group of children? Has evidence come to light since the Cass review that helps clinicians confidently work out which 11-year-olds will become adults with gender dysphoria and which will not?
The Secretary of State has said that the criteria will stop short-term harm, and that should mean that long-term harm will not occur or go unnoticed, but history is littered with examples of things that do not cause short-term harm but do cause long-term damage. He also suggested that the trial will resolve the dispute, but sadly, I do not think that will be the case, because, first, a single trial rarely resolves a dispute; and, secondly, the comparison group, who are not getting the puberty blockers, are not randomised and are an intrinsically different population. This is bound to be highlighted once the result is published. In medicine, we have a founding principle: primum non nocere—first, do no harm. I ask the Health Secretary to please cancel this trial before vulnerable children suffer unnecessary, irreversible harm on his watch.
The shadow Minister asked about protecting the young people involved in the trial from harm. As I set out, there is intense scrutiny, and there are robust mechanisms to prevent the children involved from being harmed. She mentioned the MHRA recommendation for the lower age limit. Initially, there was no lower age limit, but a scientific dialogue between the MHRA and the trial sponsor led to publication last week of the updated protocol, which recommended the minimum ages of 11 and 12.
The gateways to younger people and children becoming involved in the trial are significant. There must be not just consent or assent from the children, and consent from their parents or guardians, but approval from the NHS care team, the national multidisciplinary team and others before anyone can be involved. As I set out, I feel uncomfortable and uneasy when considering this matter, but I think that the right way for us to move forward is to have the clinical evidence on which to base decisions. I have received reassurances about there being the highest possible level of scrutiny and protection from harm for young people involved in the trial, and that is the basis on which, on balance, I think it is right for it to proceed.
We agree that treatment should first be based on talking therapies, so that patients are given the space and support that they need, but it is crucial that young people can start those therapies as a matter of urgency, not after years of delay. Decisions about these young patients’ futures should be made in an informed way, with expert clinicians and based on the best possible evidence, which the NHS must build up safely and effectively. We support prioritising clinical evidence, so that patients’ interests are put at the heart of decision making in all areas of healthcare. Guidance and decisions around puberty blockers must be led by experts and clinical evidence, and not influenced by ideological opinion. That is why we supported the decision of the former Secretary of State, the right hon. Member for Ilford North (Wes Streeting), to pause the Pathways clinical trial while concerns raised by the MHRA were thoroughly addressed. Will the Secretary of State confirm whether the MHRA has confirmed that the concerns that led to the withdrawal of the trial have been substantially addressed, and how many children are expected to take part in the trial now that its parameters have been altered?
The hon. Lady asked about the work of the MHRA since early this year to strengthen the safeguards for young people involved in the trial. As I said earlier, I welcome the changes that it has brought forward to strengthen the criteria, which will lead to greater monitoring and clinical reassessment, and to setting objective criteria for withdrawing children and young people from the trial entirely. The MHRA has been engaged in a scientific dialogue with the trial sponsors, and it was the outcome of that process that led the MHRA, as an independent body, to publish the updated protocol towards the end of last week. Now that that is in place, we have greater reassurance about the safeguards.
The trial is expected to involve around 226 children and young people over five and a half years, with each participant potentially being offered puberty blockers for up to 24 months. As I said, a decision to withdraw is triggered by the participant meeting set objective criteria related to the risk of harm.
There was a lot of disquiet about the iterative process that the trial has gone through—that it was stopped, paused and then started again. Could the Secretary of State outline for the House how usual or unusual that is? What support can the NHS offer those families who might have hoped to be part of the trail but now find themselves excluded from it?
The hon. Lady asked how usual it is for the MHRA to work with the sponsors of trials. My understanding is that the MHRA routinely works with trial sponsors to iterate the protocols in relation to those trials. Because this trial involves children and young people, for me, the bar should be exceptionally high, to ensure that those safeguards are in place. That is why, although my starting principle is that clinical evidence is the right way to approach such a matter, I wanted that extra reassurance. That is why I asked for the most detailed possible assurances from my clinical advisers, to ensure that those robust safeguards are in place in the way the trial is now designed.
“the Pathways trial should wait for findings from former patients treated by GIDS between 2009 and 2020”
and that
“A data linkage study of 9000 patients, now adults, has full HRA approval, and NHS England has encouraged gender clinicians to cooperate, describing it as an opportunity to gather ‘high quality evidence.’”
But The BMJ reported that the clinicians
“refused to share their data”.
Hilary Cass said that was “extraordinary”. Can he tell us whether all the data that is out there is available and whether it is being shared appropriately?
It is important to understand that the information in the linkage study is much more limited than the detailed information that the research team will be able to collect about the relative benefits and risks of puberty blockers. NHS England is, however, committed to delivering the data linkage study. NHS England, since assuming responsibility for that study, has taken time to ensure that the data is shared by relevant organisations. Let me be absolutely clear, for the avoidance of all doubt, that the Government’s clear expectation is that all relevant organisations will provide the data required to complete the study.
I would add that the right hon. Gentleman refers to what happened in the Tavistock clinic and the stories that led to Dr Hilary Cass being commissioned. I think the right hon. Gentleman and I agree on how unacceptable that situation was, and I put on record my thanks to Sir Sajid Javid for commissioning the work by Dr Cass, because it has been such an important piece of work not only to expose what was happening before, but to provide a way forward.
“We will complete the implementation of the Cass Review”.
A similar commitment appeared in our own manifesto, which we are now cracking on with and delivering. Does my right hon. Friend share my concerns that the Conservatives seem to have abandoned their commitment?
Before Dr Cass did her review, the situation at the Tavistock clinic was totally unacceptable, as the right hon. Member for South Holland and The Deepings (Sir John Hayes) recognised, and we must never go back to a position where the situation is out of control in the way that it was then. In working out how to move forward, I believe that, as uncomfortable as it may make myself and others on an individual basis, focusing on the principle of following clinical evidence, demanding the highest possible safeguards and protections for the children involved, and setting objective criteria for them to be withdrawn or for action to be taken if the risk of harm increases, is the balanced and correct way to proceed.
“we are talking about a very small subset of a very small pool.”
If that amounts to a couple of hundred people as he said, it is unlikely that there would be universality of outcome, either positive or negative, because in that size of pool there are obviously going to be mixed views. If it is a small number of people who benefit, as he believes, but a much larger number who do not, what then?
Four years, three-and-a-half years, four years, six-and-a-half years, four years, three-and-a-half years, four-and-a-half years, five-and-a-half years, three years and nine months—those are the waits faced by young people in Dorset supported by Space Youth Project between their referral to the gender identity service and their very first appointment. None of them will qualify for this trial, and many will have gone into adulthood still waiting, despite commitments of more treatment and clinics. While I support the criteria for the trial as detailed in the statement, there is an inadequate capacity in the system, which is leading to even more distress for these children and their families. Will the Secretary of State update us on this issue? Most teenagers will be excluded from the trial, so they need to hear how they will be supported.
Contains Parliamentary information licensed under the Open Parliament Licence v3.0.