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The Minister for Secondary Care (Karin Smyth)
It is a pleasure to serve under your chairship, Mr Mundell. I thank the hon. Member for Caithness, Sutherland and Easter Ross (Jamie Stone) of the Petitions Committee for the way in which he introduced the debate. In his usual style, he made sure that he had talked to a range of people and experts to inform this debate.
I want to start by recognising that the thousands of signatures on the petition show the real strength of feeling on this issue. I thank everyone for taking part. I am acutely conscious of the young people, their families and people in the Public Gallery today and outside who are paying close attention to this debate and what is being said. I hope to address all the issues that have been raised—I have kept notes and listened carefully—as I know people want to get this on the record. I will say now that I will not take any interventions; I will just set out where I think we are. If I do not answer particular questions, I will get back to people.
I want to assure colleagues and the signatories to the petition, particularly young people and their families, and those who are waiting for, have had or have been concerned about gender services, that this Government will always be led by science and not ideology. We are proceeding carefully in line with clinical advice and we will always put the interests of vulnerable children first, because their health and wellbeing are not negotiable. That is our position.
Let me start, briefly, with some of the context. In 2020, NHS England commissioned Dr Hilary Cass to undertake a review of NHS children and young people’s gender services. Like others, I am sure, I have taken time over the weekend to re-read her interim report and her full report; I commend both to people with an interest in the subject.
Dr Cass is one of the most pre-eminent clinicians in her field, and her review is the most definitive assessment of its kind. It laid bare the inadequacy of the now decommissioned Tavistock Gender Identity Development Service. The interim review and final report made it clear that we needed better data and a stronger evidence base to design the right services for children and young people presenting with questions around gender dysphoria or gender incongruence, given the poor evidence base for services and treatment against rapidly increasing and, as we have heard, changing demand.
Dr Cass recommended a new model of care based on holistic assessment and psychosocial support, with further research into puberty blockers, specifically where they are not provided in isolation. The Labour party in opposition welcomed her report and accepted her findings, and we continue to do so in government. Many of the recommendations in her report are being implemented, including opening new NHS children and young people’s gender services while building the evidence base in parallel through a national research programme.
As the hon. Member for Caithness, Sutherland and Easter Ross outlined, the rationale for the clinical trial is part of the recommendations to gather robust, contemporary and comparative evidence on the relative benefits and harms of puberty-suppressing treatments in children. That is how we can decide whether puberty suppression can be an option in NHS gender care in future.
The PATHWAYS trial has undergone thorough scientific, clinical, ethical and regulatory safeguards. Following academic peer review, it was supported by the independent National Institute for Health and Care Research funding committee. It was endorsed by a multidisciplinary and multi-agency national research oversight board, and was then subject to formal regulatory approvals via the Medicines and Healthcare products Regulatory Agency; the Health Research Authority, including a review by an independent research ethics committee; and finally, the Commission on Human Medicines, which made considered recommendations to the study team that were adopted in full.
As with all complex clinical trials, the top priority of each of those organisations is the safety of the trial participants. The MHRA in particular is maintaining a high level of scrutiny and taking a cautious and measured approach. Where appropriate, after initial approvals have been granted, there can be ongoing dialogue between the sponsors of clinical trials and the MHRA. That is part of the process—I want to stress that point.
The MHRA has raised concerns relating to some elements of the trial design, and those questions obviously need answering. Rigorous and constructive discussions are accordingly under way between the MHRA and the trial sponsor.
Karin Smyth
I am not going to give way; I am going to get through these points.
The safety and wellbeing of children and young people have always been the driving consideration in every decision we have made regarding this trial, and always will be. That is why the trial sponsor has paused recruiting until these issues can be resolved. There have been calls today to cancel the pause, to continue with the pause and to cancel the trial, but the position is that the trial is paused until the issues are resolved, because we will not compromise an inch on safety. The trial will proceed only if the regulatory approval is reconfirmed. We will provide an update on the outcome of those discussions as soon as we can.
David Mundell (in the Chair)
Order. I think the Minister has made it clear that she is not taking interventions.
Karin Smyth
Thank you, Mr Mundell.
Dr Cass also recommended that we take forward the data linkage study as part of the wider national research programme. The linkage study is not a clinical trial, and as such it will not in and of itself provide the type of evidence that can demonstrate cause and effect for any particular treatment. It is observational in nature, linking and analysing existing routinely collected data for adults who were referred as children to the Tavistock before it was decommissioned. The study requires no active patient participation; instead, it relies on an analysis of digital information held within health records and other databases.
Data linkage studies have faced difficulties that are a matter of public record, but since then there have been great efforts to improve the collaboration of the adult clinics and other organisations. Important final steps are currently being taken to enable the study to begin. We expect the study analysis to then take around one year to complete. On 26 February, we laid an order before the House to make it lawful for people and organisations to share or process data that could be subject to protections under the Gender Recognition Act 2004 where it is for the purpose of the study. That order came into force last week.
The PATHWAYS clinical trial is a key step that we are taking to build an evidence base to prove whether puberty blockers are safe and effective in treating gender incongruence and gender dysphoria. As we speak, the new clinical model is collecting a consistent and comprehensive core clinical dataset while we develop a supporting national registry.
In the meantime, hormone medications are not being prescribed. NHS England now prevents the routine use of puberty-suppressing hormones in the NHS children and young people’s gender services, and the Government have indefinitely extended restrictions that prevent them being supplied privately. Last year, NHS England issued guidance to GPs that strongly advised against supporting prescribing agreements with unregulated providers, who do not always have children’s best interests at heart. That includes online overseas providers who are known to have supplied puberty suppressants and cross-sex hormones to children in the past without any proper safeguarding. NHS England issued that warning because of the serious safety risks that unregulated providers continue to pose to children in this country. In some cases, we are talking about puberty blockers being prescribed following a questionnaire or a brief Zoom call.
I will come on to other issues around future services, although I think I have answered most questions. All clinical trials have appropriate insurance to cope with the issues outlined by the right hon. Member for Tonbridge (Tom Tugendhat). The trial sponsor is King’s College, so my understanding is that the issue raised by the hon. Member for South West Devon (Rebecca Smith) with regard to the state having conflicts does not arise. The hon. Member for Bristol Central (Carla Denyer) cited regulations that were mainly from overseas, but the UK has its own regulatory independent network: the MHRA, which we work with. The Opposition spokesperson, the hon. Member for Sleaford and North Hykeham (Dr Johnson), who I respect in her role as a paediatrician, asked a number of questions about timing and process. She will be aware that there is a judicial review, but I will make sure that she gets an answer on some of those issues.
I want to update the House that since April 2024, NHS England has opened three new services in the north-west, London and the south-west. I can confirm that a fourth service will become operational at Cambridge University hospitals NHS foundation trust very shortly. Those are important services for young people and their families who are awaiting treatment and who want to understand when and how they will receive care.
Karin Smyth
I am not going to give way.
Those services operate under a fundamentally different clinical model from the Tavistock clinic. Children and young people will get comprehensive, tailored assessment and support from multidisciplinary teams made up of experts in paediatrics, neurodiversity and mental health.
Under this Government, mental health spending has gone up in real terms, and we are putting specialist mental health teams in every school to support those young people. However, I know there are still families who are desperately worried by some of the debate and are concerned about the future, often to the detriment of their own mental health. They want clarity on the options open to them. I want to end by assuring hon. Members that we will update the House on all these issues as soon as possible. I urge all hon. Members to continue to engage with the evidence that best supports our young people. That is what we, as a Government, continue to be focused on.