Puberty-suppressing Hormones

Statement

The following Statement was made in the House of Commons on Wednesday 11 December.

“With permission, Madam Deputy Speaker, I shall make a Statement on puberty blockers.

At the outset, I wish to make clear the principles that drive the Government’s approach to this issue. First, children’s healthcare must always be led by evidence. Medicines prescribed to young people should always be proven to be safe and effective. Secondly, evidence-led, effective and safe healthcare must be provided to all who need it, when they need it. Thirdly, this Government believe in the dignity, worth and equality of every citizen, and recognise that trans people too often feel unsafe, unrecognised and unheard, and that must change. None of these simple ambitions has been achieved in recent years. Medicine has been provided with insufficient evidence, and young people have been left to go without the support and care that they need. This Government are determined to change that.

The Cass review made it clear that there is not enough evidence about the long-term effects of using puberty blockers to treat gender incongruence to know whether they are safe or beneficial. That evidence should have been established before they were ever prescribed for that purpose. It is a scandal that medicine was given to vulnerable young children, without proof that it was safe or effective, or that it had gone through the rigorous safeguards of a clinical trial.

Following the Cass review, the NHS ceased the routine use of puberty blockers to treat gender incongruence in children. In May, the previous Government issued an emergency order to extend these restrictions to the private sector. In opposition, my party and I, as shadow Health and Social Care Secretary, supported those decisions. Since coming into office, I have renewed this order twice, continuing restrictions until the end of this year. That was done jointly with the Health Minister in Northern Ireland, and I updated the House via a Written Statement.

While the temporary ban was in place, I asked the Commission on Human Medicines to look at the current environment for prescribing puberty blockers, and we launched a targeted consultation. The commission is an independent body, made up of leading clinicians and epidemiologists, that advises on medicine safety. It took evidence directly from clinical experts, consultant paediatric endocrinologists and patient representatives, including representatives of trans people, young people and their families. After thoroughly examining all the available evidence, it has concluded that prescribing puberty blockers to children for the purposes of treating gender dysphoria, in the current prescribing environment, represents ‘an unacceptable safety risk’. Of particular concern to the commission was whether these children and their families were provided with enough time and information to give their full and informed consent. The commission found that children had received prescriptions after filling out online questionnaires and having one brief Zoom call with prescribers from outside the UK.

Consequently, the commission has recommended that the Government extend the banning order indefinitely, until a safe prescribing environment can be established for these medicines. On the basis of those findings, I am acting on the commission’s advice and putting in place an indefinite order to restrict the sale or supply of puberty blockers to under-18s through a prescription issued by either a private UK prescriber, or a prescriber registered outside the UK. This is on the advice of expert clinicians, the independent Commission on Human Medicines—advice based on the best available evidence—and follows the cautionary and careful approach recommended by Dr Cass. The legislation will be updated today, and will be reviewed in 2027, when there will be an updated assessment of the safety of the prescribing environment for these medicines.

We are working to grow a thorough evidence base for puberty blockers. The National Institute for Health and Care Research is working closely with NHS England to establish a clinical trial on puberty-supressing hormones. The NIHR is now contracting the team that will deliver the study and is working tirelessly towards recruiting the first patients by spring. The trial is the first of its kind the world over. It will help us better understand the effects of puberty-suppressing hormones on young people, providing the robust evidence required.

The Cass review also made clear recommendations to the Government and NHS England on improving healthcare services for children with gender dysphoria. I will now provide an update on the progress made. NHS England has published its implementation plan, which will transform its services. It has also published a new services specification, to ensure that children and young people experiencing gender incongruence have an appointment with a paediatrician or mental health professional before being referred to specialist services. Dr Cass was clear on the need for the model of care to change and take account of children and young people’s holistic needs.

Since April, NHS England has opened three new gender identity services—in the north-west, in London and in Bristol—with a fourth expected in the east of England by the spring. That puts us on track to open services in every region by 2026. These services offer a fundamentally different clinical model. They bring together clinical experts in paediatrics, neurodiversity and mental health, so that care can be tailored to patients’ needs. At first, the new services were prioritising patients registered with the old Gender Identity Development Service, but I am delighted to report that the north-west and Bristol services are now taking patients off the general waiting list.

On the waiting list, Dr Cass’s review painted a picture of a service unable to cope with demand. Children and young people face unacceptably long waits for care, with some children passing into adulthood before their first appointment, leaving them facing a dangerous cliff edge. I am pleased to tell the House that NHS England is working with potential partner organisations to explore establishing a much-needed follow-through service for 17 to 25 year-olds, as Dr Cass recommended. Young people’s distress or needs do not vanish when they turn 18, and neither should their healthcare.

We do not yet know the risks of stopping pubertal hormones at this critical life stage. That is the basis on which I am making decisions. I am treading cautiously in this area because the safety of children must come first. There are some who have called on the Government not to go ahead with the clinical trial recommended by Dr Cass. Others on the opposite side of the debate want the Government to ignore the recommendations of the independent expert Commission on Human Medicines. We are taking a different approach. The decisions that we take will always be based on the evidence and the advice of clinicians, not on politics or political pressure.

Finally, there are many young people in this country who are desperately worried and frightened by the toxicity of this debate. This has not been helped by some highly irresponsible public statements, which threatened to put vulnerable young people at risk. In the past few months, I have met young trans people, who either have been, may be, or will be affected by the decisions that I and my predecessor have taken. I have listened to their concerns, fears and anxieties, and I want to talk directly to them. I know it is not easy being a trans kid in our country today. The trans community is at the wrong end of all the statistics for mental ill-health, self-harm and suicide. I cannot pretend to know what that is like, but I do know what it is like to feel that you have to bury a secret about yourself, to be afraid of who you are, to be bullied for it, and then to have the liberating experience of coming out. I know it will not feel like it, based on the decisions that I am taking today, but I really do care about this, and so do this Government.

I am determined to improve the quality of care and access to healthcare for all trans people. I am convinced that the full implementation of the Cass review will deliver material improvements in the well-being, safety and dignity of trans people of all ages, and the Government will work with them to help them live freely, equally and with the dignity that everyone in our country deserves. I commend this Statement to the House”.

20:09:00

My Lords, I thank the Minister for the Statement and the right honourable Secretary of State for the careful and sensitive way in which he delivered the Statement in the other place. In line with my right honourable friend the shadow Secretary of State in the other place, from these Benches we welcome the Government’s announcement. Whatever your politics, most people believe that one of the first duties of any Government is to protect their citizens, especially our children. As the Secretary of State said, there has been too much heat, and perhaps toxicity, around the issue of services for children experiencing gender dysphoria, so I welcome the tone with which His Majesty’s Government have approached this issue—less heat, more light—and that they continue to take an evidence-based but compassionate approach. I also take this opportunity to thank the noble Baroness, Lady Cass, for leading the review on gender services for children. The Cass review highlighted the importance of putting scientific evidence above ideology and laid out the fact that we simply do not know enough about the long-term impacts of puberty blockers on children. That is why my right honourable friend in the other place, the Member for Louth and Horncastle, when Secretary of State, banned the routine prescription of puberty blockers for gender dysphoria, and later extended that ban to private clinics. We welcome the decision of the Government to follow the recommendations of the independent Commission on Human Medicines to extend the banning order until a safe prescribing environment can be established for these medicines. This is a common-sense approach, and allows time for more evidence to be examined to consider the holistic and long-term impacts of puberty blockers on children. The Secretary of State announced the clinical trials to gather evidence but, given understandable concerns about the risks of any clinical trial, can the Minister reassure your Lordships that these trials will have robust safeguards to ensure the well-being and safety of any children taking part, while recognising the importance of having these trials in the first place? The Secretary of State in the other place also spoke about alternatives to puberty blockers for children suffering from gender dysphoria. As someone who takes an interest in social prescribing, I welcome the Government’s recognition that medication is not always the best solution, so will the Minister share details of some of the alternatives to puberty blockers that will be offered to children? Finally, noble Lords will be concerned that, despite the lack of evidence, puberty blockers were prescribed to children with gender dysphoria when their safety could not be guaranteed. What steps are the Government and the NHS taking to ensure that a similar situation does not occur again and that future decisions are led by evidence? I look forward to the Minister’s responses.

My Lords, on these Benches we welcome the tone of the Secretary of State’s Statement. I have often said that there are many ways of being human. Growing up can often be a very trying time for teenagers. How much more difficult, then, for those young people with gender distress who are struggling with finding out who they are while being different from their peers, and all without adequate support? It is high time that proper services were put in place for young people struggling alone with these issues. Their families too need help to support them at this difficult time. For too long, children and young people who are struggling with their gender identity have been badly let down by a low standard of care, exceptionally long waiting lists, even by the standard of mental health waiting lists, and an increasingly toxic debate. We always want to see policy based on the evidence. With any medical treatment, especially for children and young people, the most important thing is to follow the evidence on safety and effectiveness. It is crucial that these sorts of decisions are made by expert clinicians, based on the best possible evidence. It is also important that the results of the consultation and the advice of the Commission on Human Medicines are made public. Some might wonder why the treatment is deemed not safe for gender dysphoria patients but safe enough for children with early-onset puberty. More transparency might clear up the confusion and give more confidence to patients and their families. However, the Secretary of State himself admits that he does not know what effect the sudden withdrawal of this treatment for young people already embarked on a course of puberty blockers will have. These are the young people with the most urgent need for other types of care in the current situation, so what clinical advice have the Government taken about the effect of withdrawing these drugs on the physical and mental state of young sufferers of gender incongruence already on the drugs, and what physical and psychological support will be offered to them? In the current circumstances, plans for a clinical trial are welcome, but we would like to know the criteria for those eligible to participate. What assessment have the Government made of the recent Council of Europe report, which raises the ethical and rights implications of offering participation in the trial to only a small group of patients? If the only way to continue access to these drugs is through participation in the clinical trial, whose scope, length and start date have yet to be announced, this lays the Government open to accusations of coercion and breaches of human rights. We welcome the plans for additional treatment centres in Manchester and Bristol as well as London, but can the Minister say why they will not be up and running for two years? Is it lack of funding, lack of premises or lack of sufficient therapists with the appropriate specialist training? This is a very sensitive area, so the wrong people could do more harm than good. If that is the reason, is there a plan for training up more qualified therapists in time for the opening of the regional treatment centres? I very much look forward to the Minister’s replies to these questions.

My Lords, I start by thanking the noble Baroness, Lady Cass, for her work in this very important area. I also refer to the actions taken by the previous Government, which set in train the action we are continuing. As both the noble Lord, Lord Kamall, and the noble Baroness, Lady Walmsley, rightly said, this is about keeping children safe. There is nothing more important than evidence-based action—which is what we have before us—and taking the necessary steps. The Cass review made it clear that there is not enough evidence about the long-term effects of using puberty blockers to treat gender incongruence to know whether they are, first, safe and, secondly, beneficial. It is important to bear both in mind. The Commission on Human Medicines independently found that clear evidence of unsafe prescribing exists and recommended that there should be a ban until there can be a safe prescribing environment. That is where we start, and last week’s laying of legislation stops that unsafe prescribing to children and allows time to develop the necessary safeguards, as recommended by the commission. I should just clarify that the legislation is indefinite, not permanent. There will be a full review in 2027 so this continues to be a very live issue. The clinical trials, referred to by both the noble Lord, Lord Kamall, and the noble Baroness, Lady Walmsley, will be a world first. It is important to pay tribute to that. In addition to the work currently being undertaken to respond to the recommendations of the Commission on Human Medicines, the trial is presently undergoing development and approvals. The aim is to begin recruitment early in the new year. I am sure there will be an opportunity to update the House on that detail. In answer to the point from the noble Baroness, Lady Walmsley, the numbers will be uncapped, which is important. I am sure we all agree that better-quality evidence is critical. The development of the clinical trial between the National Institute for Health and Care Research and NHS England will provide the better-quality evidence that we are all looking for. The noble Baroness, Lady Walmsley, spoke about new services. To make the situation clear, NHS England has already opened three new services in the north-west, London and Bristol. The fourth will be in the east of England and will open its doors in spring next year. The noble Baroness also asked about the timetable; we are on course to have a service in every region of England by 2026. I cannot always confirm developments of that nature, so I am glad to do so because it will help reduce the waiting list, which noble Lords are rightly concerned about. It will also bring services closer to home, which is crucial too. Furthermore, this is a very specialist area, so recruitment and training are key. This is part of the reason for the—I would not call it a delay—realistic timetable. There is also the need to work with local trusts and take into account all the various operational considerations, so realism rather than delay is how I would put it to the noble Baroness. I agree with the points made by noble Lords on the Front Bench about tone and discourse. I am very grateful to the noble Baroness, Lady Walmsley, and the noble Lord, Lord Kamall, for welcoming the way the Secretary of State made the announcement and what the announcement refers to. We have a real responsibility in this House—and outside it—to handle conversations on this topic extremely sensitively. This is about people’s lives. I absolutely agree with the point just made: the public debate has been frighteningly toxic. Irresponsible statements made recently have put young people at risk of serious harm and that has to stop. That is one of the many reasons I welcome the Statement—and the tone and discourse this evening. On the point made by the noble Lord, Lord Kamall, about alternatives to puberty blockers, no exact alternatives are being offered. However, within the new services there will be an emphasis on, for example, psychosocial support. In response to the point made by the noble Baroness, Lady Walmsley, about the—she did not use this word, but perhaps I might—transparency of evidence, all the commission’s recommendations have been published in full as part of the Government’s response to the consultation. The full advice, as I hope the noble Baroness will understand, was prepared solely for Ministers, but we are considering whether it should be published. I know the noble Baroness will understand that, as with all advice prepared for Ministers, there are legal and other matters that must be considered before it can happen. I will say a word on mental health support, which is so important for children and young people. An offer of an appointment with a mental health professional has been made to everyone on the national waiting list for children and young people’s gender identity services. Those who joined the waiting list on or after 1 September will have an appointment with a mental health professional or paediatrician before being referred to specialist gender services. Those who are not on the waiting list and are directly affected by the restrictions can access NHS mental health services through a dedicated single point of contact, supported by clinical nursing. I hope that is helpful, and if there are any points I have missed—

Can the Minister address the issue of the children who are part-way through a course of treatment? Will they get mental health support as a priority?

For those who are already on puberty blockers, there is an immediate withdrawal. But I hope that what I have outlined on mental health support covers all the areas the noble Baroness, and indeed all of us, are concerned about. The approach is as compressive as possible, and the new gender services I described should make it even easier to provide the service. It is not a matter of waiting until 2026; we absolutely understand the need to provide that support now, and we are making that available.

20:25:00

My Lords, I echo the thanks given to the Secretary of State for his careful and scientific approach to this issue and for his very sensitive Statement in the other place. It might be helpful to elaborate on just one or two of the points that have been raised, particularly the use of puberty blockers for precocious puberty—that is, for children who enter puberty too early—which is a licensed use of these drugs. We are confident about that use because we have many years of experience, and because it is a very different situation from prescribing for young people with gender dysphoria. The difference is that children with precocious puberty have an abnormal hormone environment, which we normalise, whereas in young people with gender dysphoria we are taking a normal surge in pubertal hormones and disrupting it. That is why it is much less clear what the long-term impact of that intervention is, and why we need careful clinical trials. The second thing it would be helpful to clarify is the appropriate question, asked by the noble Baroness, Lady Walmsley, about children and young people who are already on puberty blockers from private or overseas sources. In addition to the comments made by the Minister, it is important to know that NHS England has set up a telephone number that young people and families can ring to receive a mental health triage. Young people’s mental health services have been forewarned and are on hand to provide that triage for that small group of young people who may be in significant distress because of fear of interruption of their supply of puberty blockers. There is provision that, in those circumstances, and where the clinician thinks it is in the best interests of that young person to continue on puberty blockers, an NHS prescriber is allowed to continue the prescription. We hope that those in distress will come forward and contact NHS England and therefore be supported through the system. One of the other misunderstandings about puberty blockers is that they have become totemic as the main treatment or entry-point treatment for young people who want to transition, or who may in the longer term be trans but may not go on to a medical pathway. Young adults have said to us that they wish they had known when they were younger that there were more options for them than a binary medical transition, and that there were many more ways of being trans—that they could remain gender fluid, continue to be non-binary, or in the longer term continue to be a cis adult, as some do, and not go through any medical interventions at all. Having a multidisciplinary team that can support young people in that decision-making without necessarily rushing them into a medical pathway is crucial, and that is what the new services have now embarked on doing.

I thank the noble Baroness for bringing her expertise directly into the Chamber. We are very glad that she is in the House to do so, and she has actually answered a number of the points better than I ever could. I will emphasise one point that I am particularly interested in, because I know it has been raised a lot, about why the legislation is being laid in respect of the use of medicines just for gender dysphoria. The noble Baroness, Lady Cass, referred to this. It is really important to emphasise that the medicine might be the same, but the fact is that it is not licensed for gender incongruence or dysphoria—that is the key point. These medicines have not undergone that process, which means that safety and risk implications have not yet been considered. It is true that there are licensed uses of the medicines for much younger children or for older adults, but the issue here is about adolescents, and it is an entirely different situation.

My Lords, perhaps I might return to the conventional asking of a question to the Minister—a very quick question. There are a number of practitioners who are considering, if not giving, sex steroids to patients who are requesting gender reassignment; either oestrogen or progesterone, or the equivalent male hormone. Have the Government yet considered how patients will be treated in this situation? There are certain, clear dangers involved.

I understand the point my noble friend rightly raises, and I emphasise again that what matters here are safety considerations—particularly when we are talking about children and young people— but also the evidence in respect of treatments, that there should be the prescription only of medication which is safe and appropriate to the actual patient and situation.

My Lords, given that puberty blockers almost invariably lead to cross-sex hormones, can the Minister explain why the proposed trial cannot study those who have already used or are using puberty blockers, rather than starting with a new cohort of children? Given that the trial will look at the long-term effects on health, does she have any indication of how long that trial will need to continue, and is it right that it might be for up to 30 years?

I do not recognise the last point that the noble Baroness made about the time. The aim is to start recruiting participants in spring next year and, as I mentioned, the National Institute for Health and Care Research is working with NHS England to develop the clinical trials. They are the first in the world and I will be very pleased to provide further information as and when it is available.

My Lords, I commend the Secretary of State—and, indeed, the Minister. I commend the Secretary of State for his very clear Statement and for his courage, because he has had to stand his ground. He kept his cool, despite receiving unpleasant smears and abuse not only online, but even, to a certain extent, from the Back Benches in the other place. I am slightly confused about something. I think we can see now that puberty blockers are a medicalised euphemism for chemical castration. The same kinds of drugs, when given to Alan Turing, were used as punishment for being gay. I am still not convinced, and do not really understand why the Government still think it is appropriate to conduct a clinical trial on children with these drugs. The Minister emphasised “uncapped” as though that was positive, whereas I thought that was scary. As this medical scandal unravels, more and more young people are de-transitioning, but the NHS has no services to deal with this. I wonder whether the Minister would agree, perhaps, to meet some of the charities that are doing this kind of thing—there is Genspect’s Beyond Trans and its special service providers —just to discuss what the NHS might need to look at, moving forward in a different way.

I very much welcome the generous and supportive comments of the noble Baroness, Lady Fox, in respect of the Secretary of State’s Statement. I am grateful for those. I note that she finds the reference to “uncapped” scary. I presented it as the way to gather the widest amount of relevant evidence, because that is a clinical trial; that is what is so important. The reason it is being done is that there is insufficient evidence and there has not been such a trial, and we need to do one for this particular situation. In respect of meeting charities and others, the Secretary of State has been very keen to—what I would call—reset the relationship with various groups which all have different sets of thoughts on this. I have joined him in those meetings. He has also been meeting those with lived experience. We continue to do so. We have wanted to detoxify the debate, and those meetings have helped immensely. We will continue to have that listening ear.

My Lords, I too welcome the Statement. The tone, as we have already heard, has been absolutely right. Thinking about the clinical trial, I would like to know a little more about the timing. If we are intending to run a clinical trial that is going to be looking at efficacy and safety, it will not be an easy trial to run and it is going to take some time. It would be really welcome if the Minister could keep the House informed, which she has already promised to do. I am particularly interested in hearing the Minister’s view on the following point. It is really important to get this clinical trial on the puberty blockers going, but we also need to understand the value and the evidence supporting all the other interventions too—the psychosocial support, the psychological support, and all the other interventions—so that it is not just this clinical trial but a broad understanding of what really helps these young people. ‘

My noble friend is right to raise the second point. It is a whole range of interventions, and that is certainly something that we have very much in mind for consideration, for the reasons that we have heard in the Chamber this evening and the points that my noble friend makes. In respect of timings, it is a planned pathway study and that includes a clinical trial component. It is, as I said, to build evidence. I am glad to say that it remains on track to commence recruitment early in 2025, but only after there has been ethical approval. When that is granted, that is when the final study protocol will be ready, and I know that noble Lords will have a lot of interest in that. We will be issuing further updates in early 2025, and if there are any particular questions, noble Lords are very welcome to raise them with me.

My Lords, my question follows on from that of the noble Baroness, Lady Walmsley, about the scale of the trial. I also note the report from the experts at the Council of Europe, which the noble Baroness referenced. In the other place, the Secretary of State said in response to my honourable friend Carla Denyer that the clinical trial would be “uncapped”, and the Minister repeated that word this evening. However, an article published yesterday in the Metro, arising from various freedom of information requests and headlined, “Trans Youth ‘Languishing’ While Waiting Six Years For Gender Healthcare”, said: “If a trans young person joined the waiting list for gender-affirming healthcare on the NHS today, they would have to wait 308 weeks for a first appointment”. In that context, I am struggling to understand where the Government will secure the resources from to run a trial to provide the resources needed to have this uncapped clinical trial allowing access to puberty blockers.

In view of what the noble Baroness said, it is quite important to consider that the children and young people’s gender services waiting list currently has 6,237 people on it. I certainly agree that waiting lists for these services are too long. We are committed to changing that, which is why I outlined the timetable for the new gender services and the opening of the new centres. They will increase clinical capacity and reduce waiting times for sure. On the point the noble Baroness raised, there is a commitment to the clinical trial, and I am glad there is. As we have brought forward this legislation in an absence of evidence, it is incumbent on us, as a Government, to follow through on what the previous Government started in train, which is to use a clinical trial to provide the evidence. Otherwise, the debate would remain uninformed and not evidence-based, and that cannot be helpful.

My Lords, I welcome the Statement and congratulate the Secretary of State on the moral clarity and leadership that he has shown in balancing the evidence base with compassion. Perhaps I may press the Minister on a few points. An indefinite ban is not the same as a permanent ban. Is there a chance that the indefinite ban, which goes to 2027, may segue into a permanent ban as more information and evidence arise over the next few years? Given that it is pretty well understood that puberty blockers have given rise to fertility problems, bone health issues and psychological health issues, I cannot understand the inconsistent policy of keeping children currently on puberty blockers in the system, when we know that there is no positive evidence base and only a negative one. I think that will affect many children. My final point is about the eight new regional centres that will be set up. Will we be certain that the ideologically-driven zealots—clinicians who misuse their position and have prescribed unsafe puberty blockers for children and young people—will not find themselves in these new facilities? That is an important issue as we wait for the clinical trial and ruminate on the issues that the noble Baroness, Lady Cass, mentioned. We need to start again on this and to understand that there are more treatments available for the most vulnerable children, who we need to protect, than merely puberty blockers.

I certainly agree with the noble Lord about the vulnerability of children and young people in this regard, which is why we are taking this action. His last point gives me the opportunity to say that we are committed to implementing the recommendations of the Cass review in full. That is a very useful guideline and tool for us to use. I have no expectation that the situation that the noble Lord described in his third point will happen. Recruitment is subject to all the usual provisions, and I know that the gender services will seek to recruit very positively. If the noble Lord finds out anything else, I am sure he will raise it with me. On whether the ban could become permanent, the review—at the risk of repeating myself—will report in 2027, as the noble Lord said. I believe that we should wait for that.

My Lords, like other noble Lords, I welcome the tone of the Statement. In today’s society, there is huge pressure on young people, through social media and more widely. I would really not want to be a teenager right now. There is also huge pressure on the NHS, with multiple calls on its services. Can the Minister elaborate a bit more on how His Majesty’s Government are going to increase the number of staff and make sure they are trained to support young people? How can we support those staff? This is a tough area for them to work in. We also need to protect them from malicious complaints to make sure that they can do their job.

I am glad that the noble Baroness has raised the issue of staff. It is vital that people are allowed to go about their work—as the noble Baroness, Lady Cass, should have been too—without fear of physical, verbal, online or direct abuse. I am sure that we all agree that the abuse has been an absolute disgrace. I agree about protecting those who are doing this. On the point about service, as has been said, this is about a group of vulnerable children and young people. It is our duty to provide the services to support them and to make them evidence based.

20:46:00