Pathways Study: Puberty Suppression

With your permission, Madam Deputy Speaker, I shall make a statement on the Pathways trial.

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.

I call the shadow Minister.

I declare an interest as an NHS consultant paediatrician and a member of the Royal College of Paediatrics and Child Health. What does this trial do? Put simply, it takes physically healthy children with normal pubertal development and subjects them to powerful drugs that may weaken their bones, affect their ability to think, damage sexual function and make them unable to have children of their own. Serious stuff—and for what? To treat a diagnosis of gender incongruence that will probably resolve without treatment.

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.

I agree with the shadow Minister that most children and young people who are questioning their identity and gender are likely to resolve those questions on their own, and I think Dr Cass would agree with that. As I said in my opening remarks, for the majority of children who question their gender, we should let them be; they will resolve the matter through their friends and family and their own development. We are talking here about a small subset within a small group of children who need further support. I also agree with the shadow Minister that the situation before Dr Cass did her review—the situation that had developed in the last few years before the turn of the decade—was totally unacceptable, and we should be clear that that was wrong.

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.

I thank the Secretary of State for his statement. The Conservative party committed to and commissioned the Cass review, and today’s statement takes forward Dr Cass’s recommendations in full—guided not by ideology, but by evidence. Some Members who are critical of that approach have said in this place that these young people just need love. I agree that we should show trans people and trans young people more care and compassion—far too often, those things have not been demonstrated in public discourse in recent months and years—but trans people and trans young people also need and deserve high quality, evidence based and timely healthcare. I therefore welcome today’s statement and the Secretary of State’s commitment. Will he say that this Government are still committed to rolling out gender clinics in every region?

As my hon. Friend will know, the recommendations in Dr Hilary Cass’s review set out how to establish better services for young people in the future. The focus of today’s statement, the clinical trial, is just one part of the wider work on how best to support young people who need extra support in this situation. It was welcome that there had been, at least until recently, a cross party consensus that Dr Cass was finding the right way through this difficult matter.

I call the Liberal Democrat spokesperson.

I thank the Secretary of State for advance sight of his statement. The Liberal Democrats have long highlighted the need for better access to specialist healthcare for children and young people struggling with gender identity. The closure of the Tavistock clinic and its inadequate rating by the Care Quality Commission demonstrated that urgent change was needed. Young people struggling with gender identity face serious challenges. They have been badly let down for years by low care standards and extremely long waiting lists. On top of that, they have to contend with a toxic public debate, which comes at a huge cost to their wellbeing at a particularly vulnerable stage in their life. The average three year wait for a young person to see a specialist can be extremely harmful at such a vulnerable age.

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?

I welcome the fact that the hon. Lady agrees with the Government that we should base our decisions about whether and how to provide support for children, particularly in the case of the treatment that is at the centre of this clinical trial, on clinical evidence and the expert advice of clinicians. There can be no one in this field more widely respected than Dr Hilary Cass, whose recommendations form the basis of the decision that we have taken as a Government.

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.

I welcome the statement and the Health Secretary’s calm approach, which contrasts sharply with some of the language that is used around this very important issue. When it comes to the Pathways trial, does he agree that we must follow the science and avoid vilification, polarising language and politicisation for the good of young people and our communities?

I absolutely agree with my hon. Friend about the importance of following clinical evidence and taking a clinically led and evidence based approach to this decision. As I said, I have felt uncomfortable and uneasy about some of the challenges raised by this matter, but for me, the right way to move forward is to follow the clinical advice, and to base future decisions on clinical evidence, given that I have received the most robust assurances about the safeguards that are in place to protect young people involved in this trial from harm.

I call the Chair of the Health and Social Care Committee.

I welcome the statement and this approach. I thank the MHRA for engaging with the Committee when we asked it specific questions about this. It told us that the role of the regulator is to ensure that participants in any clinical trial are kept safe and are exposed to medicine only if there is a reasonable expectation of a positive effect, and that is what was foremost in its mind. It also reassured us that if it had not felt 100% assured, it would have not allowed the trial to go forward.

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?

I am sure that the hon. Lady will agree that this is now one of the most heavily scrutinised clinical trials in this country in recent history, and rightly so—it is right that it is so heavily scrutinised and that we all seek assurances about the safeguards in place. It is right that, as Health Secretary, I made sure that I got those detailed safeguards before coming to the House to set out the Government’s position today.

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.

Before my election, I was a scientist—albeit not in the health sciences. Using that background, however, can I agree with the Secretary of State that healthcare practices and medical trials, like all scientific trials, must be led by expertise and evidence, not politics? Therefore, what precedent is there for politicians, including Members of this House, intervening in a medical trial?

My hon. Friend raises an important point about the relationship between politics and clinical evidence and clinically led decisions. Being led by clinical advice and clinical evidence is a decision that I and this Government stand behind. In this case, it is a matter where in considering some of the issues raised, I have felt uncomfortable and uneasy, but that commitment to clinical evidence, particularly recommended by someone as widely respected as Dr Cass, is the basis on which we can move forward. As I mentioned in response to the Chair of the Health and Social Care Committee, because this involves children and young people, I wanted to receive extra assurances that the clinical advice was robust and that the safeguards would be as robust as possible. That is the assurance I have received, it is what I very much wanted to receive before coming here today.

I thank the Secretary of State for his statement. No child put on puberty blockers at the earliest stage of puberty and whose natural puberty is permanently blocked will ever have an orgasm or be fertile. No child can consent to that. Around 2,000 children have already been given puberty blockers for gender distress, so there is ample information available on impact and outcomes held by gender clinics. It makes no sense to experiment on even more children while this exercise remains incomplete. Why is the Health Secretary not prioritising the completion of this important data linkage study before experimenting on more children?

The hon. Lady refers, apparently with some certainty, to what she considers to be the clinical outcomes of these puberty blockers on young people. I have to say, with all due respect, that I would trust Dr Cass’s conclusion more than the hon. Lady’s, which is that there is not evidence about the risks or benefits of these medications. That is exactly why Dr Cass was so clear in recommending a trial to find that clinical evidence, because that is the basis on which we can take those decisions.

I thank my right hon. Friend for his detailed and nuanced statement. Notwithstanding the risks of using puberty blockers on children, which he has outlined, and the inability to guarantee that they will not be harmed by participation in the trial, how can the trial determine long term impacts of the use of puberty blockers when it lasts for only two years? Does that not show the inefficacy of the trial itself? If we really are committed to evidence, which I agree we should be, why are we not—as we just heard from the hon. Member for Reigate (Rebecca Paul)—using the long term data that already exists, which came from clinics such as the Tavistock and was gathered over many years?

As a result of the work that the MHRA has been doing with these trial sponsors in recent months, there are now objective set criteria against which children and young people involved in the trial would be automatically withdrawn. Those criteria, as I set out earlier, will stop the short term harm, and the view of the National Institute for Health and Care Research is that this means any long term harm should not occur or go unnoticed. It is important that we ensure that the appropriate safeguards are in place for this trial. That is why I welcome what the MHRA has done in recent months, because it strengthens those safeguards, which are important in any clinical trial but, in this trial, could not be more important.

The Secretary of State has said that no child subject to safeguarding concerns will be considered for participation in the trial. Can he confirm, therefore, that no already vulnerable children currently in the care system will be accepted on to the trial?

The hon. Lady is right to draw attention to some of the gateways that children and young people will have to go through before being accepted on to the trial. That will involve not just the child assenting and the parents giving consent, but the NHS care team and a national multidisciplinary team, which will take into consideration all the different aspects of a child’s life that I set out in my earlier remarks about their health, but also the wider context that the children are coming from. The importance here is to ensure that there is an exceptionally high bar for children and young people taking part in this trial, and that is the process that has now been established.

I thank the Secretary of State for the considered way in which he has delivered his statement. In December 2025, The BMJ reported that “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?

My hon. Friend asks about the data linkage study, and I apologise to my hon. Friend the Member for North Northumberland (David Smith), who a few seconds ago also asked about that—I did not respond then but can now address both questions together.

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 first raised the horrors of the Tavistock clinic in this House in 2019, having been provoked to do so by staff who said that they were often under pressure to refer for life altering treatment children and young people who had experienced mental health difficulties, abuse and family trauma. Indeed, the Secretary of State will know that the Cass review found that childhood trauma, neglect and abuse featured heavily in the cohort of patients seeking gender changes. As many as two thirds of those referred had suffered neglect or abuse, with high levels of parental mental illness, substance abuse and exposure to domestic violence. So will the Secretary of State, even at this late juncture, abandon this trial? I have no reason to believe that he is anything other than a good man who wants to do the right thing. He has made it clear that he knows that this matter often sorts itself out through puberty and adulthood. I implore him to do so, for I fear that because he is a good man, he will regret this cruel experiment on harmless children.

I thank the right hon. Gentleman for his comments, and although he and I come to a different conclusion on this, I do not doubt for a second the sincerity of his motivation in wanting to protect children and young people. I actually agree with him, as I said in my earlier comments, that most young children who are questioning their gender will resolve it on their own—let them be to resolve it. But there is a small subset of children who will need extra support, and within that there is a question about whether for a very small subset of them there might be a benefit to having treatment, and that is what this trial seeks to conclude.

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.

Puberty suppressors have been used for many years for precocious puberty, but the evidence base for their use in gender dysphoria lacked rigour, so I welcome the news that the trial will go ahead, as recommended by the Cass review. Will the Secretary of State confirm that the medications are only one part of the research, and can he outline some of the other measures being looked at? Given the small numbers expected to take part in this trial, will research also be undertaken into the impact on young people who are showing gender distress but are unable to access a trial or, of course, be prescribed puberty blockers, in order to get a full clinical picture? Will he furthermore ensure that all young children showing gender distress will have some care and support?

My hon. Friend rightly points out that the clinical trial—the Pathways study, which is the subject of this statement—is just one part of the wider work being done to make sure that the support is there for children and young people who are questioning their gender and who might, or might not, need support in order to feel well about themselves. The Pathways horizon is an observational study of all children and young people attending NHS children and young people’s specialist gender services. Pathways connect is a brain imaging study. Pathways voices will interview young people. Horizon intensive is about making sure that there is a comparison group of 300 participants who are expressing gender incongruence but not receiving puberty suppressing hormones, as my hon. Friend suggested.

I welcome the statement and the Secretary of State’s tone, because it is important that we all acknowledge that we are dealing with young children and their safety is paramount. While many children will resolve the issues themselves, there is an important group of children for whom that will not be the case; they face enormous challenges and we must do everything we can. I also welcome the Secretary of State’s stress on the importance of talking therapies, but given the long waiting lists and the difficulty in getting access to those talking therapies, how will he ensure that children get the support they need and that there are adequate staff who are properly qualified to support them?

I thank the hon. Lady for her remarks, and for her tone and approach to this sensitive matter. Sadly, we have waiting lists across many different parts of the NHS. This Government are determined to deal with that so that everyone can receive the appropriate treatment. There are wider questions, which we could debate at another time, about the support that children who are questioning their identity might need. The focus of today’s statement is specifically on the clinical trial, and it is right that we let that happen. The trial will last five and a half years and it is right that we do that thoroughly, because I do not want this country to be taking decisions in future that are not based on the most solid evidence.

I welcome confirmation that the Pathways clinical trial will continue with the modified protocols in place; it was an important manifesto commitment for the trans community. Does the Secretary of State agree that it might help to reduce the risk in the long term of vulnerable young people seeking to access drugs online, which is currently happening in my constituency?

Dr Cass has raised that point a number of times, particularly when she has spoken in public and been interviewed on her concerns about young people accessing equivalent drugs through an unregulated source—through online sources that are not carefully controlled and where there is no monitoring of the effects on young people. That is part of her motivation for recommending the approach that she proposes. As I said earlier, I and the Government want the decisions about what role, if any, such treatments play in the future to be based on the clinical evidence, with the highest possible safeguards in place for children involved in the trials.

I want to press the Secretary of State a little further on looked after children in particular. At the beginning of his statement, he said that his bottom line is to protect the safety and wellbeing of children and young people. Given that parental or guardian permission has to be granted for the trial to take place, I am wondering who will give that permission for a child in care. Will it be himself, the Secretary of State? Will it be the foster parent? Will it be a social worker from a local council? We already know that looked after children are overrepresented within the cohort of children with gender dysphoria. Ultimately, if we are going to protect them and make sure that their safety and wellbeing are at the forefront, we need some clear direction on what that is going to look like.

I thank the hon. Lady for her question, which highlights the importance we all place on making sure that vulnerable children are protected in the way that the trial proceeds. Perhaps I can offer her some detail which might reassure her by explaining who is on the national multidisciplinary team. As I mentioned earlier, the national multidisciplinary team will have to give permission for young people to be involved in the trial, as will the NHS care team. That national multidisciplinary team has an independent chair and its membership comprises senior clinicians from a range of clinical backgrounds: paediatric endocrinology, general paediatrics, child and adolescent mental health, clinical nursing, safeguarding, adolescent medicine, allied health and service leadership. Those are the specialisms represented in the national multidisciplinary team, which means that those aspects of the child’s wellbeing are all being considered in that process.

On a quiet day in Westminster, I have had a chance to dive into the Conservative party’s 2024 manifesto, which promised: “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?

I share my hon. Friend’s disappointment that the cross party consensus that was in place about the way to approach the issue does not currently seem to be holding. I urge Opposition Members who are not aligned with that cross party consensus to reconsider their position, because that is the best way forward for our country.

The Secretary of State mentioned following the advice of clinical experts, but has he sought any meetings with whistleblowers, former clinicians at the now closed Tavistock clinic, detransitioners and psychologists such as James Esses and Marcus and Sue Evans, who are all campaigning to stop this trial and the testing of children as young as 11 years old, who are too young to access social media and certainly too young to give meaningful consent to taking banned drugs?

I reassure the hon. Lady, as I set out in my responses to earlier questions, that while my starting point is that clinical evidence should be the basis for our way forward, I have taken the responsibility to interrogate that with the highest level of scrutiny in order to ensure that the conclusions are as robust as possible. That has involved my ensuring that my clinical advisers at the Department for Health and Social Care and the other bodies associated with the Department have provided me with the highest level of detail and reassurance about the safeguards in place. Although I stand behind the principle of following clinical advice and basing conclusions on clinical evidence, I feel that it is important for me, as Health Secretary, to have an extremely high bar for a decision of this magnitude.

The Secretary of State has repeatedly told us that he feels uncomfortable and uneasy. If I am totally honest, I do not think that he believes that this is right at all. I think that in his heart, he knows that this is wrong. Of course it is wrong: stopping an 11-year old—a primary school child—from going through the natural process that we must all go through to become adults by injecting them with drugs is wrong. We must think about the title of the statement: puberty suppression. People do not need a medical or a science degree to know that the suppression of puberty is wrong. This is a moral question and I am afraid that as it stands the Secretary of State is on the wrong side of it. He says “let them be”—if only they had let Keira Bell be. When she had the treatment, Keira Bell was much older than these children will be when they are given it. She regrets it all and now campaigns to stop this. There is huge public opposition to this—

Order. I assume the hon. Gentleman is getting to a question.

There is huge opposition to this among people who vote Labour, including many of my constituents, so I implore—

Order. The hon. Gentleman’s question is far too long. I call the Secretary of State.

Despite our different conclusions on this matter, I respect my hon. Friend. Part of taking decisions as Health Secretary involves sometimes approaching issues where one might feel uncomfortable on a personal level, but none the less being guided by the right principles in order to take decisions for other groups of people in the country and for the country as a whole. I am not in any way disputing how difficult a matter this is; it is one where I, as Health Secretary—and my predecessors—have had to carefully consider how we ensure that the clinical basis for any future decisions is robust and that we can point to it as a foundation for where this matter settles.

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.

Despite all the safeguards and precautions that the Secretary of State has listed, we must be clear about what this trial actually does: it proposes to give puberty blockers to children as young as 11 that may well make them sterile for life, all to treat something that the Secretary of State also says is likely to get better by itself. I accept that this trial may well create clinical evidence, but at what price? How can this damage to children ever be justified?

Although the hon. Gentleman comes to a different conclusion from the one that I and the Government have come to, he poses the right question when he asks what harm do we need to protect against while getting clinical evidence. If we are to be led by clinical evidence, it is important to have that evidence in a way that we can rely on, but particularly because it involves children and young people, it is incumbent on us to ensure that the level of protection against the risk of harm is exceptionally high. That is why the strengthening of the protocol announced by the MHRA last week provides that higher level of assurance that I have sought to interrogate and to ensure is there in as robust a way as possible. That gives us the confidence that those safeguards are in place as the trial proceeds.

I agree with the Secretary of State that we should come to this subject matter with care and compassion given the age profile of the children affected. He majored on the small number of people who would take part in the trial. In fact, he said that “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?

The number of expected participants in the trial is 226. That is not a firm target—it does not have to be exactly that number—but that is the number at which statistically significant conclusions can be drawn. The 226 will fall into two camps: one will access the medical treatment immediately and the other will access it after one year. In that way, we will have clinical evidence from which we can draw conclusions and on which we can base future decisions. The number has been chosen so that the evidence can be relied on in the future to take decisions about whether, and if so how, to continue the use of these treatments.

A parent cannot consent to their child engaging in sexual activity and soon they will not be able to consent to their child having a social media account, so why does the Secretary of State think that a parent should consent to drugs being administered to their child to supress their puberty and alter their sexual development?

We are following clinical advice. We are ensuring that there is a triple lock on the consent for children and young people to be involved in this trial, involving the consent or assent of the young person themselves, parents or guardians, and the NHS care team—the national multidisciplinary team that I mentioned earlier. That is how this trial ensures that there is a high bar for being involved in it and that all aspects of a young person’s life are considered before they are approved.

I thank the Secretary of State for the manner of his responses.

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.

There is a fundamental difference of approach between me and the hon. Lady. The reason for the trial is not to ensure that young people on the waiting list can get access to treatment; the trial is to find an evidence base on which to take future decisions about whether young people should be offered treatment and, if so, in what way. Talking about waiting lists and the trial combines two things that, in my view of the world, really do not have a relationship in this context.

No child is born in the wrong body. The scandal of thousands of children being put through irreversible medical intervention such as puberty blockers causing infertility, among other harms, has gone on for more than a decade, and it will go down as one of the worst examples of state failure in our history. Officials advise and Ministers decide. Why does the Secretary of State not use the considerable executive power vested in him personally to overrule his official advice, pause the puberty blockers trial and put child safety first?

This trial has been paused since earlier this year while the MHRA worked to strengthen the safeguards. Those stronger safeguards are now in place, which gives greater protection to young people who are involved in this trial. As I mentioned in my remarks earlier, one of my responsibilities as Health Secretary is to interrogate the detail to ensure that safeguards are adequate. I take that responsibility particularly seriously when it involves children and young people, and that is to ensure that we have the highest possible safeguards against harm of anyone involved in this trial.

The Health Secretary told us that his bottom line was to protect children, but he also conceded that puberty blockers can affect adversely bone density and brain development, so why is he taking the risk? Our 11-year olds are not guinea pigs; they are children entitled to grow up without state sponsored harm. Surely that should be the starting point.

The reason for having this trial is to establish whether there are in fact benefits to this treatment for some children and young people as well as what the risks of harm are. I believe it is right, on balance, to proceed with this clinical trial to get clinical evidence on the basis of having the highest possible protections against a greater risk of harm to children and young people involved in this trial.