*Updated 12 December*
The government has confirmed that the existing emergency measures restricting the sale and supply of puberty-suppressing hormones will be made indefinite. This decision follows independent expert advice from the Commission on Human Medicines (CHM) that there is currently an unacceptable safety risk.
Legislation will be updated today [Wednesday 11 December 2024] to make the order indefinite.
The below explains why this decision was made and what support there is in place for children and young people.
What are puberty blockers?
- Puberty blockers are a type of medication called Gonadotrophin-releasing hormone (GnRH) analogues. They are licensed only for use in young children (for precocious puberty) or older adults (for certain cancers).
- They are not licensed for use for adolescents, and they are not licensed for gender incongruence or dysphoria.
- Licensing of medicines requires a robust assessment of safety and effectiveness data. These medications have not undergone that process, which means the safety and risk implications for use with gender dysphoria have not been assessed.
Why are you restricting puberty blockers indefinitely?
- In March this year, NHS England took the decision not to commission the routine use of puberty blockers for the treatment of gender incongruence - informed by an evidence review conducted by the National Institute for Health and Care Excellence (NICE).
- These findings were echoed in the Independent Review of Gender Identity Services for Children and Young People (the Cass Review), and accompanying systematic reviews, which found insufficient evidence to support the safety or clinical effectiveness of puberty blockers for adolescents.
- The Commission on Human Medicines (CHM), an independent expert body which advises ministers on the safety and efficacy of medicines, has also advised that the current prescribing environment is unsafe, and that an indefinite ban should be put in place until a safer prescribing environment can be established.
What is an 'unsafe prescribing environment'?
- Through their review, CHM found poor medical and prescribing practice has taken place that goes against GMC guidance.
- CHM reviewed evidence from a range of sources of private prescriptions, including examples of access to puberty blockers via different routes and jurisdictions, UK based websites advertising private transgender care for children and young people from non-UK organisations, and heard from support organisations that acknowledge that the standard of healthcare provided by some private healthcare providers may not be consistent with a UK NHS level.
- Overall, CHM saw evidence of poor-quality advertising, prescribing and communication by private practitioners to children and young people that would constitute unsafe practice.
- As an example, CHM found instances where children received prescriptions after filling out online questionnaires and a brief call with prescribers outside the UK.
- We are prioritising patient safety, which is why we have accepted CHM's recommendations in regards to this legislation.
What are you doing to support children and young people with gender dysphoria?
- NHS England has opened three new children and young people's gender services in the North West, London and Bristol. These services operate under a fundamentally different model, embedding multi-disciplinary teams, including mental health support and paediatrics, within specialist children's hospitals.
- A fourth service in the East of England is planned to open in Spring next year and NHS England is advancing towards meeting its commitment for there to be a specialist children's gender service in every region by 2026.
- These new services will increase clinical capacity and reduce waiting times, so patients can be seen sooner and closer to home.
- NHS England's ambitious two-year action plan to implement the Cass Review sets out how they will continue to improve and transform services.
- The NHS has commissioned an additional support offer for young people who are waiting to be seen by the new gender services, through an assessment with their local Children and Young People Mental Health services.
- The NHS is also extending an offer of targeted support from local mental health services to anyone who is not on the NHS waiting list, but has been affected by the banning order.
Who did you engage with on the consultation?
- The consultation engaged widely, including groups that represent the LGBT+ community and those representing patients and service users and their families, clinicians, pharmacists, charities, regulators and experts.
- Respondents also had the opportunity to make representations to the Commission on Human Medicines.
- The Health and Social Care Secretary, Wes Streeting, has also personally engaged with a range of stakeholders on this issue, including with children and young people, and their families, with lived experience of gender incongruence.
- This government will continue to engage with, and listen to, the trans community.
When is the clinical trial launching?
- NHS England and the National Institute of Health and Care Research (NIHR) are working together to set up a study into the potential benefits and harms of puberty suppressing hormones as a treatment option for children and young people with gender incongruence. The study forms part of a wider joint programme of research underpinning the design and delivery of new NHS gender services.
- Better-quality evidence is critical if the NHS is to provide reliable, transparent information and advice to support children and young people, and their parents and carers, in making potentially life-changing decisions.
- Subject to securing all usual approvals, including ethical approval, the study aims to begin recruiting participants in early 2025.
- All NIHR-commissioned research must go through robust scientific and ethical approval processes.
Why have you continued this ban whilst still allowing puberty blockers to be prescribed for other conditions?
- While the medicine may be the same, they have not been licensed for gender incongruence or dysphoria.
- Licensing of medicines requires a robust assessment of safety and efficacy data. These medications have not undergone that process, which means the safety and risk implications for use with gender dysphoria have not been assessed.
- In particular, licensed uses of the medicine are for much younger children (precocious puberty) or older adults (certain cancers), but for adolescents the interaction with all the different processes of puberty may be very significant, which is why more evidence, and a better understanding of their impact is needed in this patient group.
- That is why the clinical trial will measure a range of potential treatment benefits and harms (for example whether puberty suppressing hormones impact in a meaningful way on levels of anxiety or depression, on body image, or brain development) using a range of validated tools, questionnaires and user feedback.