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
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.
“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.
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.
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.