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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, 2,000 children have already been treated with puberty blockers in this country. They were treated at the now closed Tavistock clinic. More scandalously, they went on to adult clinics and we are entirely in the dark about how they are today. The data linkage study to analyse the information about those children has not yet been done. A shocking six out of seven of those adult clinics they went on to have not released the data, despite Parliament legislating for it.
So, what are Ministers doing to require adult gender clinics receiving public money to provide that data? What is the current status of that process? And, when the Government still do not know what happened to the 2,000 children already treated, why and on what grounds are they exposing another cohort of healthy children to medical harm before that question has been answered? It is no good to point to the fact that the noble Baroness, Lady Cass, recommended a trial. Government cannot and should not outsource such decisions and it will be no defence to the litigation coming down the line, as it already is in the US, that the noble Baroness told the Government to do it.
In any case, there are major issues about consent, particularly given the nature of the trial as currently put together. I am deeply troubled by how the informed consent of children can possibly be obtained when they are too young to appreciate what they stand to lose: as young as 11. It is important to set out what they stand to lose. Commencing puberty blockers at an early age may make fertility preservation for these children impossible. Studies show that puberty blockers may affect brain development, including their IQ and memory function, as well as their bone density and organ development. There is currently no long-term data sufficient to quantify those risks. Then, of course, there is a risk that normal adult sexual function—let us call a spade a spade; we are talking about the ability to ever experience sexual pleasure—does not develop when puberty is interrupted at such an early stage.
In these circumstances, it is inexplicable that the Government have rejected the MHRA’s recommendation that children under 14 should not be included in any trial. This trial is for children from the age of 11. How does the Minister justify that children under 14 are to be included in the trial? And how does she argue that any child can give informed consent to such risks? Please can the Minister confirm that these risks and all others will be expressly communicated to the children and families concerned? If this trial goes ahead, it is inevitable that irreversible, unnecessary harm will be done to at least some of these children.
Finally, could the Minister confirm that the Government have carried out an assessment of the future liability coming down the tracks to the NHS, and therefore to the taxpayer? Have the ongoing treatment costs, the treatment-related harms and the future litigation risks been assessed? What is the estimated cost to the NHS and the taxpayer of those, and how will that be funded?
Polling in December 2025 showed that almost 70% of the public was against giving puberty blockers to children and 63% wanted this trial to be stopped. As the Government consider a fresh start in other ways, I beg the Minister to think again and stop this trial.
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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. It is not unusual for that to happen in a medical trial. It is not unusual for trials to stop and take note of what has happened initially and then for revisions to be made to the basis on which they are run.
We on these Benches believe very strongly that medical treatment should be based on science and evidence, not on belief and ideology. This trial has been under sustained attack from political organisations such as Sex Matters which do not believe that trans people should exist or should exist with the dignities that they currently do. This trial is currently the only legal route for anybody to access puberty blockers, so in the interests not just of accurate scientific evidence but of children who need this treatment, will the Minister ensure that the people who have undertaken this research are protected from the relentless political attacks against trans people?
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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 evidence. Nobody in your Lordships’ House can predict the evidence because it does not exist yet.
As I say, I think the previous Government had the right approach, which was why we supported it in opposition. They accepted the recommendations of the review by the noble Baroness, Lady Cass, and, again, I feel that that is the responsible way forward.
It is worth reminding ourselves that the use of puberty-suppressing hormones has been banned indefinitely for gender dysphoria outside of research settings, so the trial we are talking about today is being set up to gather the evidence that the last Government wanted and we continue to want.
The trial was first approved by regulators in November 2025 and in February the MHRA requested changes to the trial protocol to make it even safer. This is quite normal in how these matters are dealt with. Perhaps I can give the noble Baroness, Lady Cash, the clear assurance that the changes to make it safer—which is absolutely the right thing to do—were around the age of those included in the trial, and monitoring possible impacts on bone density, future fertility and cognitive abilities. These are all points and concerns rightly raised by the noble Baroness, Lady Cash, and have indeed been raised on a number of occasions in your Lordships’ House. I emphasise that it is usual for dialogue such as this to take place during a trial.
Reference was made to safeguards. There are a number listed. Again, I would ask noble Lords to look at them, but I will mention some of them. Children can participate only with the consent of a parent or guardian, and the child themselves must consent or assent. To the point raised by the noble Baroness, Lady Cash, they can participate only if they are not subject to any safeguarding concerns, and if there is sufficient understanding by the young person—but also by their parent or guardian—of the nature of the treatment and 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 only if they are already accessing NHS gender services, including participating in a tailored package of psychosocial care.
All these safeguards rightly build in considerable safety preservation and ensure that it is the right people. I emphasise that there is no compulsion to take part in a trial, and indeed just getting close to one is a rigorous process. Due to ongoing legal proceedings, as referred to by the noble Baroness, Lady Cash, recruitment on to the trial will not begin immediately. We are currently in a set-up period, and we will set out our future plans in due course.
The noble Baroness, Lady Barker, referred to protecting researchers from “relentless” attacks. I hope the whole of your Lordships’ House would agree with that. Those who carry out research and those who lead reviews—such as the noble Baroness, Lady Cass, and indeed many others on our own Benches—in many different areas have been subject to the most relentless attacks. These have not all been via social media: sometimes they have been physical attacks. Violence is totally unacceptable and we cannot condone it in any way.
To the noble Baroness, Lady Cash, I say that prospective participants will indeed have comprehensive information on the advantages and the potential risks, in a way that speaks to how they need that information. The minimum ages were agreed through detailed scientific discussions between the MHRA and the trial sponsor. This is all driven by what will provide the right evidence that we need for decisions, and that evidence is clinically led. I return to the point about age, which I know exercises noble Lords, and is a fair question to raise. It was recognised during discussions between the trial sponsor and the MHRA that the right balance had to be struck between the maturity level of participants and providing treatment at the most clinically appropriate point in puberty. That would, of course, be earlier for birth-registered females compared with birth-registered males.
The noble Baroness, Lady Cass, may make this point herself, but I am grateful to the noble Baroness, who will be available for a drop-in discussion with anybody who would like to go into more detail. I hope that noble Lords will avail themselves of that.