Ban on puberty blockers to be made indefinite on experts’ advice
Existing emergency measures banning the sale and supply of puberty-suppressing hormones will be made indefinite, following official advice from medical experts.
- Sale and supply of puberty blockers via private prescriptions for the treatment of gender incongruence and/or gender dysphoria to be banned indefinitely in UK for under 18s
- It follows a targeted consultation and advice on patient safety from the independent Commission on Human Medicines and Cass Review
- Government and NHS continue to improve children’s gender services to provide all-round holistic support
- Legislation will be updated today to make the order indefinite and will be reviewed in 2027
Existing emergency measures banning the sale and supply of puberty-suppressing hormones will be made indefinite, following official advice from medical experts.
The Commission on Human Medicines (CHM) has provided independent expert advice that there is currently an unacceptable safety risk in the continued prescription of puberty blockers to children. It recommends indefinite restrictions while work is done to ensure the safety of children and young people.
The NHS stopped the routine prescription of puberty blocker treatments to under 18s in March 2024, following the Cass Review into gender identity services.
Puberty blockers for the treatment of gender incongruence and/or gender dysphoria in under 18s were banned temporarily in May 2024 after the Cass Review found there was insufficient evidence to show they were safe. Legislation will be updated today to make the order indefinite and will be reviewed in 2027.
Health and Social Care Secretary Wes Streeting said:
Children’s healthcare must always be evidence-led. The independent expert Commission on Human Medicines found that the current prescribing and care pathway for gender dysphoria and incongruence presents an unacceptable safety risk for children and young people.
Dr Cass’ review also raised safety concerns around the lack of evidence for these medical treatments . We need to act with caution and care when it comes to this vulnerable group of young people, and follow the expert advice.
We are working with NHS England to open new gender identity services, so people can access holistic health and wellbeing support they need. We are setting up a clinical trial into the use of puberty blockers next year, to establish a clear evidence base for the use of this medicine.
Professor Steve Cunningham, Vice-Chair of the Commission on Human Medicines, said:
The Commission on Human Medicines was requested by the Secretary of State for Health and the Northern Ireland Minister for Health to provide advice on the safety of GnRH agonists when used to suppress puberty. CHM made 8 recommendations.
CHM has advised that a statutory indefinite ban is placed on the use of GnRH agonists for puberty suppression until our 3 recommended structures are in place to support safe UK prescribing, with a first review date of 2027.
The indefinite ban is made in the context of a significant waiting list for gender specialist services in the UK. In making this decision, CHM considered the safety, actual and potential, of using GnRH agonists to suppress puberty, and also risks to children and young people associated with accessing GnRH agonists via alternative routes.
Dr Hilary Cass, author of the independent review of gender identity services for children and young people, said:
Puberty blockers are powerful drugs with unproven benefits and significant risks, and that is why I recommended that they should only be prescribed following a multi-disciplinary assessment and within a research protocol.
I support the government’s decision to continue restrictions on the dispensing of puberty blockers for gender dysphoria outside the NHS where these essential safeguards are not being provided.
James Palmer, NHS Medical Director for Specialised Services, said:
Evidence reviews by NICE and NHS England, supported by Dr Cass, clearly showed there is not enough evidence to support the safety or clinical effectiveness of puberty suppressing hormones for the treatment of gender dysphoria or incongruence, which is why the NHS decided that they would no longer be routinely offered to children and young people.
We welcome the government’s decision to further ban access through private prescribers, which closes a loophole that posed a risk to the safety of children and young people, but this will be a difficult time for young people and their families who are affected, so we are extending an offer of targeted support to anyone affected by the banning order from their local mental health services.
The Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence (NICE) will be undertaking work in response to the recommendations of CHM, including developing standards.
We are relentlessly focused on transforming healthcare in this country for all people as part of this government’s Plan for Change, and the government is working with NHS England to implement the recommendations of the Cass Review, with a fundamentally different and improved approach to care.
Reforms to gender services are centred around offering holistic support for patients and their families. Up to 8 new regional centres are being rolled out to offer enhanced mental health support for all children and young people under the age of 18 and ensure those on waiting lists can be seen sooner. 3 new regional centres are already open. Services in London and the North West opened in April and a service in Bristol opened in November.
New providers will be coming onstream in the coming years, starting with the new East of England service which is expected to open in early 2025.
In addition, the Cass Review recommended a clinical trial to determine the effectiveness of puberty suppression and the safety of prolonged treatment. The National Institute for Health and Care Research (NIHR) is working closely with NHS England to begin a clinical trial and aim to recruit the first patients by spring 2025.
The banning order will continue restrictions on the dispensing of puberty blockers prescribed by private UK-registered prescribers for gender incongruence and/or gender dysphoria to under 18s not already taking them.
It also prevents the sale and supply of the medicines from prescribers registered in the European Economic Area or Switzerland for any reason to those under 18.
NHS patients who are already receiving these medicines for gender incongruence and/or gender dysphoria can continue to access them, as can patients receiving the medicines for other uses.
For people whose access to puberty-suppressing hormones may have been discontinued and are not on the waiting list of children’s gender services, NHS England will offer a targeted support from local NHS mental health services in England.
Background information
The Medicines (Gonadotrophin-Releasing Hormone Analogues) (Restrictions on Private Sales and Supplies) Order 2024 will come into force on 1 January 2025 as the current emergency order expires.
The NHS is extending a targeted support offer to anyone affected by the banning order from their local mental health services. Children, young people and their families can access this service, which is being coordinated through NHS Arden and GEM, by contacting [email protected] or calling 0300 131 6775 and selecting option 3.
If people are unsure how the ban applies to their circumstances, further information is available from the National Referral Support Service for NHS children and young people’s gender services (see ‘Patients and parents: letter from NHS England regarding the implications of new government policy’).
The service also provides details of organisations that people can contact for help and support.
The General Pharmaceutical Council has published a resource for pharmacy professionals (PDF, 225 KB) to support them in providing information, support and services to children and young people with gender incongruence or dysphoria.
Anyone in need of urgent support can contact NHS 111 and choose the mental health option.
Advice on getting mental health support is also available on the NHS website
Important updates on NHS England reforms of gender identity services
A new interim service specification published (June 2023)
An interim service specification was published which describes:
- how the new services will take a more cautious approach to assessment, diagnosis and intervention, including social transition particularly for younger children
- that the primary clinical approach will be psychosocial and psychological rather than medical
Training and education delivered by the Academy of Medical Royal Colleges (February 2024 - ongoing)
To support the establishment of new services, NHS England commissioned the Academy of Medical Royal Colleges to design and deliver the induction training for new clinical staff.
National clinical policy for puberty suppressing hormones (March 2024)
A new clinical commissioning policy was adopted that prevents the prescribing of puberty suppressing hormones to children and young people under 18 years of age for children and young people who have gender incongruence and/or gender dysphoria due to the limited evidence around safety, risks, benefits and outcomes.
Tavistock GIDS was brought to a managed closure (March 2024)
NHS England brought the Gender Identity Development Service (GIDS) at the Tavistock and Portman NHS Foundation Trust to a managed close. As part of this, the waiting list was temporarily transferred to NHS England while new services are established.
2 new national children and young people’s gender services opened in London and the North West (April 2024)
Two new NHS children and young people’s gender services became operational in April 2024, in the North West and London.
Established a research oversight board to oversee an academic strategy (April 2024)
The National Research Oversight Board includes the National Institute for Health and Care Research, and a range of experts in research is guiding the approach to a comprehensive programme of research.
Enhanced Mental Health Support offer extended to young people on the national waiting list (April 2024)
The NHS has commissioned an additional support offer for young people who are waiting to be seen by the new children and young people’s gender services, through an assessment with their local children and young people’s mental health services.
A specification changing the referral pathway into the children and young people’s gender service (August 2024)
Through publication of a service specification that describes access arrangements to the national waiting list, the NHS confirmed that from 1 September 2024 all new referrals to NHS children and young people’s gender services must be made through NHS secondary care services (mental health or paediatric services) to ensure that:
- every child or young person has a thorough assessment of need
- those who need it receive appropriate support from local teams while they remain on the waiting list
The new services will establish how support is given to families of younger children as close as possible to the referral date.
Publication of the Cass Review implementation plan (August 2024)
The Cass Review implementation plan outlines the steps that NHS England has already taken, guided by interim advice from Dr Cass, and sets out how NHS England will take forward the 32 recommendations made in the final report.
Third new South West service opens in Bristol (November 2024)
The new service opening in Bristol started seeing patients from the national waiting list in November.
A fourth service will be opening in the East of England (expected in early 2025).