PATHWAYS Study: Puberty Suppression
House of Lords · Lords Chamber · 24 Jun 2026 · 42 speeches · Official Report
Statement
The following Statement was made in the House of Commons on Monday 22 June.
“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, and at times struggled, with the profound challenges that this subject raises. In all my consideration and deliberation over this matter, my bottom line has been to protect the safety and well-being of children and young people. The way to do that is to follow expert clinical advice and to 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 well-being were 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 honourable 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 in the NHS as everyone else.
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 well-being. 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 qualify for the trial will be low, and the safeguards to ensure their safety and well-being are rigorous. I have sought and had reassurance that once participants are on the trial, they may be withdrawn at any point.
As honourable 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 well-being 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 honourable 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 well-being and for withdrawing them from the trial, there is now intense scrutiny, and there are robust mechanisms to prevent harm 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”.
My Lords, the proposed PATHWAYS puberty blockers trial for 226 children as young as 11 risks becoming a medical scandal unfolding in real time. Gender-incongruent children include some of the most vulnerable children in society, with disproportionate numbers of that cohort having autism or mental disorders or being children in care. There is an unknown and inestimable correlation with social media that is yet to be uncovered. The challenges for these children and their families, and the difficulties they face, are not to be underestimated, but gender-incongruent and gender non-conforming behaviour is also often characteristic of children who grow up simply to be gay. Surely the Minister does not truly agree with a trial which will place children who would otherwise simply grow up to be healthy gay and lesbian adults on a pathway that may impair their fertility and their sexual development. The data shows, and the Cass review accepted, that a very large majority of children presenting with gender incongruence will resolve without medical intervention. I assume that the Minister accepts this. That being the case, this trial will be subjecting many physically healthy young children to completely unnecessary medical risks. Let us be clear. The medical risks inherent in taking puberty blockers at such a young age are truly life-altering. They include possible lifelong consequences for brain development, including IQ, bone health, fertility and adult sexual function. Shockingly,...
My Lords, this Statement takes place in the context of a relentless campaign against trans people that started among right-wing politicians in the United States of America but has been seized on here: the bandwagon has been jumped upon by politicians in this country. That is the context. We on these Benches have a policy towards trans people that is based on our belief that trans people not only exist but have a right to exist, and they have a right to exist with the same dignity as the rest of us-and part of that is having access to appropriate healthcare. I ask the Government, as, I hope, they seek to defend this test against the kind of political campaigning that we have just heard, to bear in mind that the use of puberty inhibitors is not the harmful intervention that has just been characterised. It is a safe medical intervention that has been used for different conditions since the 1980s, and there is already a lot of data on it. However, as the noble Baroness, Lady Cass, identified in her review, an absence or at least an insufficiency of data about the use of inhibitors in relation to people who have gender dysphoria. That is why this trial, consisting of 226 people, in a highly regulated period of group activity, has been allowed to go ahead in order to generate the data that she says we need. It is true that last week the independent MHRA approved an update to the basis on which the trial is going to happen, in order to make sure that the safeguards were increased....
My Lords, I am grateful to the noble Baronesses, Lady Barker and Lady Cash, for their contributions, both of which highlight why my right honourable friend the Secretary of State led on this Statement by saying that this is “a sensitive, emotive and difficult issue”. He also said, which goes the point raised by both noble Baronesses, albeit coming at it from very different angles, that our duty as a Government-a duty for any Government and one which the last Government accepted and acted on-is “to protect the safety and wellbeing of children” and “to follow expert clinical advice and take an evidence-led approach”. We, like the previous Government will be sticking to that. The noble Baroness, Lady Cash, used the word “outsourcing”. I do not believe that the last Government outsourced responsibility when NHS England commissioned a review from the most respected paediatrician in this area, the noble Lady Baroness, Lady Cass, who we are fortunate to have with us now in the House. I do not believe the last Government outsourced. I think they took a responsible, evidence-led approach. It is worth reminding ourselves that the noble Baroness, Lady Cass, said at the time of her review: “This is an area of remarkably weak evidence”. Again, I agree. It is also important to observe a very strong divergence of medical opinion. There is always a choice. We can continue with uncertainty in an unsafe setting, where there is that strong divergence of medical opinion, or we can seek the...
My Lords, I remind the House that the next 20 minutes are for questions from Back-Benchers only.
I thank the Minister. The noble Baroness, Lady Barker, mentioned the need for data and scientific evidence. For the sake of transparency, we should mention that the Liberal Democrats received £1.33 million from Ferring Pharmaceuticals, which produces some of these puberty blockers. Further, just for clarification, Sex Matters has never believed that trans people do not exist. It is important to put that on the record. I will press the Minister on the data linkage studies, because we would not need to put forward 226 vulnerable young people had NHS England and Ministers acted with a more robust strategy two years ago, when we raised this issue in the House, and forced the data linkage information from GIDS and others to be released so that it could be peer reviewed. Had that happened, we would have all the data on the short-term implications of these puberty blockers and on the long-term ramifications, and we therefore would not need this dangerous and risky puberty blockers trial, which, I have to say to the House, is going to be subject to very significant litigation.
I am sure that the noble Lord will understand from my earlier comments that I do not accept the characterisation of the trial. I urge all noble Lords to look at the facts on the safety provisions, requirements and stringency, which have massively increased-perhaps since some noble Lords originally looked at the matter. Implicit in the noble Lord’s query is to question why we are having a clinical trial when there are a number of children who have already taken puberty blockers. That is a fair question, but I remind the noble Lord that the conclusion of the noble Baroness, Lady Cass, was that there was not enough evidence, for all the reasons I referred to. It might be helpful to make clear that the information collected by the linkage study, to which the noble Lord referred, is much more limited than the detailed information that the research team will be able to collect on the relative benefits and the risks. I confirm that NHS England, which is responsible for the data linkage study, is taking the time to ensure that data is shared by the relevant organisations-which, after all, is exactly what we are all after.
My Lords, it is such a shame that the party opposite resiled from cross-party agreement on this research. It is fair to question its motivation for doing that and possibly reach the conclusion that it is unsympathetic to trans people. I welcome the Statement and my noble friend’s calm approach, which contrasts sharply with some of the language that has been used around this important issue. When it comes to the PATHWAYS trial, does my noble friend agree that we must follow the science and avoid vilification, polarising language and politicisation, for the good of young people and our communities?
I certainly do agree with my noble friend. Indeed, her observations apply to any matters in respect of health, which should be evidence-led, based on fact, and based and rooted in scientific evidence. What we are dealing with here, as I said, is effectively a choice: a choice to do nothing and continue not providing the right healthcare in a safe and correct manner or to seek the evidence, as an independent review by the most esteemed paediatrician-as I said, it started under the previous Government, and rightly so-has advised us to do. I must emphasise that, if anybody listened, as I did, to the Secretary of State making his Statement in the House of Commons, I hope they will have got a sense that, actually, no one has jumped into this decision. What the Secretary of State said was that it was important to step back and look at the evidence. He himself told the Chamber how challenging he felt that was. I ask noble Lords never to underestimate how challenging this is, no matter what Government, what party, or what individual.
My Lords, I agree with what the noble Baroness just said, but I have to say, before I ask my question, that I am hugely disappointed that the noble Baroness, Lady Thornton, has chosen to question the motives of parliamentarians who are raising legitimate questions. That is no way for us to deal with an issue that is incredibly sensitive and involves children. Clearly, a lot of very elaborate safeguarding protections are being put in place for this trial. There is an argument sometimes, when so much of that kind of thing is necessary, whether that in itself tells us something that we need to know about such a trial. However, if the trial leads to the puberty blockers being given the go-ahead, what can she tell us about the extent of the protections and safeguards that will be made available to all children who would then be eligible for these drugs? My concern, if they do become widely available, is that the pressure from teenagers to get access to those drugs will mean that it will not be possible to control it in quite the same way as this trial is being controlled at this time.
I understand the point that the noble Baroness is making but, in answer to her first question, this is not outwith any trial or intervention because there always has to be the clinical evidence and the approach to make sure that we are always seeking benefit, not harm. I am glad that the noble Baroness acknowledged the extensive safeguards. I hope that would reassure your Lordships’ House. Indeed, for children and young people who do take part in the trial, there will, for example, be repeated follow-up physical checks, questionnaires, blood tests, bone density scans and cognitive testing, all at the relevant time points. There will be psychosocial care throughout the trial. Importantly, the protocol also clarifies that, where there are significant concerns-again, I know this is a matter of concern about psychological well-being-that case then has to be promptly reviewed by the right clinician. As for the future, I think we should wait for what the trial says. I am not going to speculate. I point out that we are not waiting, in terms of NHS care and support. Three services for children and young people have already opened in the north-west, London and the south-west for those with gender dysphoria. NHS England will aim to deliver service provision in each region of England by the end of 2026-27. Again, that programme of work, rightly, was started under the previous Government. I think we all acknowledge that there are young people with gender dysphoria. They are to be seen,...
My Lords, this is complex, and people across both sides of the House share one objective: to be cautious, careful and protective of children and young people. It is not my place here to answer many of the perfectly valid questions that have been raised, but I am developing a briefing based on proceedings in the Commons yesterday and I am listening carefully today, so I will not pick up on issues around the linkage study. I will refer to the Minister on one or two things. The noble Baroness, Lady Cash, is right to say that the vast majority of children and young people desist, but the noble Baroness, Lady Barker, is also right to say that some do not. The clinicians working in the new centres are gaining considerable experience and working holistically to try to determine which young people-a tiny number-they feel may benefit from these medications. I am not worried about the children in the trial but I am seriously worried about the children not in the trial. Approximately 240 children who have come to the new clinics have admitted to being on an extraordinary cocktail of medications, including testosterone from age 11, with facial hair at 13. Why are they doing this? They are not being perverse: we have told them for 15 years that these drugs are safe, effective and even life-saving, so is it any surprise that they will now go to any lengths to get them? They are not foolish, and they say they want to know the answers on that. We as the medical profession have created this...
I agree with the noble Baroness and I thank her for the offer of the briefing, which I mentioned earlier, and for her observations. I associate myself with what she said about the complexity of the matter, which is why I take it so seriously. The fact is that this situation exists. I am exercised about those who are accessing puberty blockers in an unregulated fashion. It is extremely concerning, which is another reason for this trial, as well as the services being set up. That is why we indefinitely banned the sale and supply of puberty blockers via private prescriptions, taking effect from January 2025. If offences are committed then those involved will be brought to justice, and rightly so.
My Lords, in my pre-political life I was a senior teacher at a very large comprehensive school, and responsible for child protection and what used to be called pastoral care. I dealt with lots of children who were confused about their sexuality, their place in the world and many other issues. I am afraid that I too would have asked the questions that the noble Baroness, Lady Cash, asked, based on that real experience. My question is aligned to my past experience. Studies show that a disproportionate number of children and adolescents with gender distress have neurodivergent conditions, such as autism. These are protected under the Equality Act. Could the Minister explain how neurodivergence was taken into account when designing the PATHWAYS trial, in particular the consent process-that is what troubles me the most, if I am honest-and any equality impact assessment?
The noble Baroness gives me the chance to reiterate that all the questions are valid. We are dealing with a complex, sensitive and difficult issue. What matters is that we get to the right place. As the noble Baroness, Lady Cass, said, I know we are all agreed on protecting children and young people. That is our motivation. The noble Baroness asked about consent. As I said, children can participate only with the consent of a parent or a guardian, and the children themselves must consent or assent. The individual circumstances and nature of a child will be closely considered as part of the consideration. That is absolutely crucial. Children and young people may participate only if they are not subject to any safeguarding concerns. I am happy to speak in greater detail to the noble Baroness. All of this will be extremely rigorous, and rightly so. When we talk about the trial, we are talking about volunteers-that is crucial. They can participate only if they have been deemed clinically appropriate by both the NHS care team and the national multidisciplinary team. There is, correctly, the opportunity at every level to consider every child or young person as an individual, which is so important.
Baroness Alexander of Cleveden
As some noble Lords know, I have some experience in my own family of the challenges around gender dysphoria and the difficulties for the trans community. I also have the experience of my mother, who was a haematologist at a time when there were great controversies surrounding that discipline. I was struck by what the noble Baroness, Lady Cass, said: there are GPs, psychiatrists and paediatricians-all sorts of medical professionals-wrestling with what the evidence may or may not show. While this is an extraordinarily difficult area, does the Minister agree that, in a world where there have been difficulties in the recent past, the responsibility of legislators is to try to equip all those professionals in the future with a clinically approved and evidence-led approach? It is only by having a highly safeguarded trial that we will move forward in a way that supports professionals operating in this area. If we demonise those individuals, the risk is that we never secure the evidence we need for the future.
I agree with that. In the Statement itself, the Secretary of State made the point that PATHWAYS is rightly one of the most scrutinised UK clinical trials of recent times. I am sure we all welcome that.
My Lords, I would like to take the Minister down memory lane and explore with her the Mental Health Act and consent by those under 16. Can she confirm the law relating to that is still Gillick competence? My other questions follow on from that. In the situation where within the research programme they determine that the child is Gillick competent but the parents disagree, what remedies do the parents have and would they be able to go to court to challenge that, and be funded to do that? On the reverse, if the child is not deemed to be Gillick competent to give consent, and then the parents can give consent but are in dispute with each other, what remedies are there for them to settle that matter, and would they be funded to bring any such remedy?
I will approach this in the most straightforward way I know. Obviously, if there are other matters, I would be very happy to talk to the noble Baroness, as I have before. From my point of view, the number one safeguard is not an either/or. Participation can occur only with the consent of a parent or guardian and-not or-the child themselves. In some of the circumstances the noble Baroness raised, that will not be an issue. Clearly, if there is any doubt about consent, assent or suitability, the child or young person will not be included in the trial; it is only where it can be shown that all the safeguards apply.
My Lords, I listened very carefully to both sides of the argument, which is very emotional and charged because people hold strict views on the trans community or the risks to children. Without the clinical trial, where will we be? Is not the clinical trial needed to answer some of the very questions that have been asked?
The noble Lord takes me back to where I started. This Government, any Government, have a choice, but there is no neutral option here. We know that the status quo-which the last Government accepted and the noble Baroness, Lady Cass, clearly identified-is totally unacceptable and young people are not being protected. It would not be responsible to do nothing about that. We can discuss and disagree or agree about what the right thing is to do, but in his Statement, the Secretary of State made it clear that he has a responsibility to look at evidence and take clinical advice. That is the right thing to do.