Written questions by Pochin.

What assessment he has made of the potential merits of including a control group of children who receive no puberty suppression in the PATHWAYS trial.

Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence. The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data. Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the National Institute for Health and Care Research website at the following link: https://fundingawards.nihr.ac.uk/award/NIHR167530 It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones. The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial. After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.

What safeguarding measures are in place to ensure that families do not feel pressured into the PATHWAYS trial.

Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence. The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data. Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the National Institute for Health and Care Research website at the following link: https://fundingawards.nihr.ac.uk/award/NIHR167530 It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones. The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial. After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.

What therapeutic or psychosocial interventions must be provided before a child is considered for the PATHWAYS trial.

Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence. The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data. Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the National Institute for Health and Care Research website at the following link: https://fundingawards.nihr.ac.uk/award/NIHR167530 It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones. The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial. After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.

What long term monitoring will be in place to track adult reproductive, sexual and psychological outcomes of PATHWAYS trial participants.

Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence. The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data. Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the National Institute for Health and Care Research website at the following link: https://fundingawards.nihr.ac.uk/award/NIHR167530 It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones. The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial. After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.

What assessment he made of the potential merits of (a) a feasibility study and (b) external peer review of the PATHWAYS trial.

Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence. The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data. Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the National Institute for Health and Care Research website at the following link: https://fundingawards.nihr.ac.uk/award/NIHR167530 It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones. The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial. After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.

For what reason the PATHWAYS trial follow up period is limited to two years.

Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence. The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data. Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the National Institute for Health and Care Research website at the following link: https://fundingawards.nihr.ac.uk/award/NIHR167530 It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones. The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial. After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.

How the PATHWAYS trial will distinguish true clinical effects from placebo or expectation effects in an open label design.

Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence. The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data. Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the National Institute for Health and Care Research website at the following link: https://fundingawards.nihr.ac.uk/award/NIHR167530 It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones. The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial. After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.

If he will publish all risk assessments conducted by his Department into the administration of puberty blockers for under 16 year-olds.

In March 2024, NHS England published a suite of documentation relating to its decision to remove gonadotrophin releasing hormone analogues as a routine treatment option in the National Health Service for children under 18 years old with gender dysphoria. This documentation included a review of the published evidence, which concluded that there is very limited evidence about safety, risks, benefits, and outcomes for the use of this medication in children with gender dysphoria.Children’s healthcare must always be evidence-led. In 2024, the Government introduced an indefinite ban on the sale and supply of puberty blockers via private prescriptions for the treatment of gender incongruence and/or gender dysphoria for under 18 year olds.As part of that legislation the Government conducted a targeted consultation and sought advice on patient safety from the independent Commission on Human Medicines (CHM) and the Cass Review. The Government response to the consultation, the full report of the CHM, and the Cass review are available publicly, and respectively, at the following three links:https://www.gov.uk/government/consultations/proposed-changes-to-the-availability-of-puberty-blockers-for-under-18s/outcome/governments-response-to-the-targeted-consultation-on-proposed-changes-to-the-availability-of-puberty-blockershttps://www.gov.uk/government/publications/chms-report-on-proposed-changes-to-the-availability-of-puberty-blockers/commission-on-human-medicines-report-on-proposed-permanent-order-to-restrict-the-sale-and-supply-of-gnrh-agonists-in-children-and-young-people-under-1https://webarchive.nationalarchives.gov.uk/ukgwa/20250310143633/https://cass.independent-review.uk/

Whether his Department is taking steps to ensure that puberty blockers are not administered to under 16 year old children with a mental illness or learning disabilities.

The Government has introduced an indefinite ban on the sale or supply of gonadotropin-releasing hormone analogues, also known as puberty blockers, for gender dysphoria and/or incongruence, to under 18 year olds. Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a package of research to find out how the National Health Service can best support children and young people with gender incongruence. This includes the PATHWAYS trial which has received independent scientific, ethical, and regulatory approvals as well as comprehensive review. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. This includes demonstrating a good understanding of the intervention and the possible benefits and risks. When making prescribing decisions, clinicians have a duty to work with their patient to decide on the best course of treatment, and must always satisfy themselves that the medicines they consider appropriate for their patients can be safely prescribed, taking into account any existing medical conditions or other factors including any disabilities.

If he will commit to publishing the results of the Tavistock clinical trial into puberty blockers for children.

There have been at least two studies relating to puberty-suppressing hormones and the Tavistock clinic. The Early pubertal suppression in a carefully selected group of adolescents with gender identity disorders study, sponsored by University College London, published its findings in 2021. The Outcomes and Predictors of Outcome for Children and Young People Referred to UK Gender Identity Development Services: A longitudinal Investigation study, funded by the National Institute for Health and Care Research, was due to end in July 2025. We would expect the study findings to be published in a peer reviewed academic journal within 12 months of the completion of the study.In addition, NHS England, in conjunction with the National Institute for Health and Care Research, is commissioning a data linkage study, which will provide different and separately valuable evidence to both understand the experience and outcomes of former patients of the Gender Identity Development Service and inform future National Health Service gender care. We would similarly expect the study findings to be published.

What assessment his Department has made of the effectiveness of the soft drinks industry levy on reducing obesity and related illnesses.

Government data shows that sugar levels in drinks in scope of the Soft Drinks Industry Levy (SDIL) reduced by 47% between 2015 and 2024, removing approximately 57,000 tonnes of sugar from these drinks. This has had benefits across all socio-economic groups.The National Diet and Nutrition Survey (NDNS), an ongoing Government-funded survey of food consumption and nutrient status in the United Kingdom, shows that sugar intakes of older children and adolescents reduced between 2014 and 2019, and the amount of sugar coming from soft drinks reduced.Academic modelling papers suggest that the following benefits may have been realised as a result of the reductions in sugar seen in drinks in scope of the SDIL:prevented approximately 5,000 cases of obesity in girls aged ten to 11 years old, with a greater impact on those living in the most deprived areas, although the paper did not find any impact on girls in the younger age group, four to five years old, or in boys at either age;shown relative reductions in hospital admissions for dental caries related tooth extractions in children aged zero to four years old and five to nine years old of 28.6% and 5.5% respectively, with no change observed for older children, and reductions being observed in children living in most index of multiple deprivation areas regardless of deprivation; andshown a reduction in the incidence rates of child admissions to hospital for asthma related complications of 20.9% in those aged five to 18 years old, with reductions being similar across age-groups and deprivation quintiles.