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James Murray
The Secretary of State for Health and Social Care
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.