Government’s response to the targeted consultation on proposed changes to the availability of puberty blockers
Published 11 December 2024
Background
On 20 August 2024, a targeted consultation was issued on proposals to make an indefinite statutory order to prevent new patients aged under 18 from being supplied with puberty blockers for the purposes of gender incongruence and/or gender dysphoria, under the care of private or non-UK prescribers.
An emergency order, the Medicines (Gonadotrophin-Releasing Hormone Analogues) (Emergency Prohibition) (Extension) (No.2) Order 2024 (‘the third emergency order’) is currently in place which:
- bans the sale or supply of puberty blockers prescribed by private UK registered prescribers for gender incongruence and/or gender dysphoria to under 18s who are not already taking them
- bans the sale or supply of these medicines against prescriptions from prescribers registered in the European Economic Area (EEA) or Switzerland for any purpose to those under 18
The third emergency order came into force from 27 November 2024 in the UK and expires on 31 December 2024.
Before this there were 2 other orders as follows:
- the Medicines (Gonadotrophin-Releasing Hormone Analogues) (Emergency Prohibition) (England, Wales and Scotland) Order 2024 (‘the first emergency order’), which placed restrictions on the sale and supply of puberty blockers in Great Britain and applied to non-NHS prescribing. The first emergency order commenced on 3 June 2024 and expired at the end of 2 September 2024
- the Medicines (Gonadotrophin-Releasing Hormone Analogues) (Emergency Prohibition) (Extension) Order 2024 (‘the second emergency order’). The second emergency order was made in effectively the same terms as the first emergency order but was extended to Northern Ireland for the first time. The second emergency order commenced in Northern Ireland on 27 August 2024 and in Great Britain on 3 September 2024. It expired across the UK at the end of 26 November 2024
These do not apply restrictions to NHS prescribing, a separate order, the National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Amendment) Regulations 2024 came into force on 26 June 2024. These regulations restrict NHS primary care prescribing of specified medicines where this would start a child or young person under the age of 18 on a medical pathway for gender incongruence and/or gender dysphoria.
The emergency orders were made in response to the recommendations of the independent review of gender identity services for children and young people (the Cass Review). The final report of the Cass Review, published in April 2024, concluded that the rationale for early puberty suppression remains unclear, with weak evidence regarding the impact of taking the medication for gender incongruence and/or gender dysphoria, and mental or psychosocial health. The Cass Review recommended that puberty suppressing hormones should only be prescribed in the context of a clinical trial or under the guidance of the national multi-disciplinary team.
Puberty blockers are also known as gonadotrophin-releasing hormone analogues or ‘GnRH analogues’ (or as ‘GnRH agonists’ in the CHM chapter). The list of GnRH analogues that are covered by this order includes medicines that consists of or contain:
- buserelin
- gonadorelin
- goserelin
- leuprorelin acetate
- nafarelin
- triptorelin
The consultation was targeted and was sent to recipients from representative groups of:
- patients and their families
- charities and voluntary and community organisations (also typically representing patients)
- clinicians (such as medical doctors, psychiatrists and psychologists)
- public bodies
- pharmacists
- academics and researchers
- organisations and clinicians in the devolved authorities
In addition, the Secretary of State for Health and Social Care and the Minister of Health for Northern Ireland jointly consulted the Commission on Human Medicines (CHM) on these proposals, as is required in legislation, for their independent expert view. CHM advises ministers on the quality, safety and efficacy of medicinal products. All written responses to this consultation were shared with CHM by officials from the Department of Health and Social Care (DHSC) for consideration.
Nine of the organisations and academics that were consulted made representations to CHM virtually to provide their views in addition to their written responses to the consultation.
The consultation closed on 8 October 2024, and we received responses from 51 of the 120 organisations to which the consultation was sent, resulting in a response rate of 42.5%. This document summarises the responses (in order of the questions posed in the consultation) and the recommendations from the Commission on Human Medicines. It also provides the response from the Secretary of State for Health and Social Care and the Minister of Health for Northern Ireland.
The names of the organisations contacted can be found at annex A. We have not named individuals to protect their identity.
Table 1: organisation type and number of responses
Type of respondent | Response total |
---|---|
Academics and researchers | 4 |
Charities and voluntary and community organisations | 21 |
Clinicians (for example, medical doctors, psychiatrists and psychologists) | 10 |
Government | 1 |
Patients and their families | 5 |
Pharmacists | 5 |
Public bodies (independent of government) | 5 |
Summary of responses
Of the 51 consultation respondents, 6 organisations responded from Northern Ireland specifically (12% of total responses), and 18 were UK-wide organisations (35%).
Responses were split between those:
- opposing the permanent order - 59%
- supporting the permanent order - 27%
- neither for nor against - 14%
Respondents (whether supporting or opposing the proposal) agreed that there was a limited evidence base to work with (with 41.2% of all respondents sharing this sentiment). On safety, respondents tended to take a different perspective depending on their overall view of the ban. Supporters of the ban questioned the safety and efficacy of puberty blockers, noting the lack of evidence of benefit. Opponents felt that there was a lack of evidence of risk, which might demonstrate that puberty blockers could be considered safe.
Respondents on both sides (43% of all respondents) were of the view that the current emergency order has negatively impacted patients’ mental health, demonstrated through anecdotal evidence.
One third of respondents highlighted that, in their opinion, the emergency ban had mitigated unsafe prescribing. Conversely, just under one third of respondents raised concerns that an indefinite ban may result in some patients substituting banned puberty blockers for alternative medicines, or obtaining puberty blockers in an unregulated market, but did not provide evidence, other than anecdotal, to support claims that individuals were already seeking alternative treatments.
The emergency order
Question: To what extent do you agree or disagree with making the arrangements in the emergency order permanent?
Of the 51 respondents to this question:
- 9 strongly agreed
- 5 agreed
- 7 neither agreed not disagreed
- 5 disagreed
- 25 strongly disagreed
The table below shows a breakdown of these results.
Table 2: breakdown of answers on making a ban permanent
Respondent | Strongly agree | Agree | Neither agree nor disagree | Disagree | Strongly disagree |
---|---|---|---|---|---|
Academics and researchers | 0 | 1 | 0 | 0 | 3 |
Charities and voluntary and community organisations | 2 | 0 | 0 | 3 | 16 |
Clinicians | 4 | 1 | 0 | 2 | 3 |
Government | 1 | 0 | 0 | 0 | 0 |
Patients and their families | 2 | 0 | 0 | 0 | 3 |
Pharmacists | 0 | 3 | 2 | 0 | 0 |
Public bodies (independent of government) | 0 | 0 | 5 | 0 | 0 |
Total | 9 | 5 | 7 | 5 | 25 |
Positive impacts
For this and subsequent questions, totals may not match the number of respondents exactly, if respondents identified multiple themes or did not provide responses to every question.
Question: In your experience, what have been the positive impacts of the emergency order?
Among the 14 supporters of making the arrangements in the emergency order permanent, 2 key themes emerged for the positive impacts of the emergency order.
Table 3: positive impacts of the ban highlighted by supporters
Theme | Number of respondents |
---|---|
The emergency ban has mitigated unsafe prescribing to children and young people | 12 (85.7%) |
The emergency ban has provided clear regulations | 5 (35.7%) |
Opponents highlighted 4 main themes for the positive impacts of the emergency order. These are summarised in the table below.
Table 4: positive impacts of the ban highlighted by opponents
Theme | Number of respondents |
---|---|
The emergency ban has provided clear regulations | 2 |
The emergency ban has limited unsafe prescribing by unregulated providers | 3 |
The emergency ban has highlighted the importance of gender affirming care | 2 |
The emergency ban has provided the opportunity to consult with stakeholders and review evidence | 3 |
These impacts were supported by a mix of anecdotal evidence and academic studies from both peer reviewed journals and non-peer reviewed articles.
Negative impacts
Question: In your experience, what have been the negative impacts of the emergency order?
Both supporters and opponents raised the concern of a potential negative impact on mental health. This was the most common theme for the negative impacts of the emergency order.
Among the 14 supporters, 2 common themes emerged for the negative impacts of the emergency order.
Table 5: negative impacts of the emergency order highlighted by supporters
Theme | Number of respondents |
---|---|
A potential negative impact on mental health | 4 |
A potential increase in misinformation surrounding puberty blockers | 3 |
Opponents of the proposal raised 5 common themes for the negative impacts of the emergency order. These are summarised in the table below.
Table 6: negative impacts of the emergency order highlighted by opponents
Theme | Number of respondents |
---|---|
A potential negative impact on mental health | 17 |
A loss of access to treatment for those who obtained puberty blockers through private or overseas providers or patients about to commence treatment | 7 |
Some patients may substitute banned puberty blockers for alternative medicines, or obtain puberty blockers in an unregulated market | 7 |
Confusion surrounding the specific regulations of the emergency ban | 4 |
Concern that the risk of bullying or similar experiences may have increased for patients | 3 |
One respondent with neutral views also drew attention to a potential negative impact on mental health. This theme was raised by nearly half of all respondents. Two further neutral respondents raised a concern about a lack of alternative care for patients seeking treatment.
These impacts were supported by a mix of anecdotal evidence and academic studies from both peer reviewed journals and non-peer reviewed articles.
Benefits
Question: In your experience, are there benefits in making the arrangements permanent?
The results to this question from the respondents were:
- 19 said yes
- 24 said no
- 4 said they didn’t know
- 4 gave no response
Supporters raised 2 main themes to highlight the potential benefits of making the arrangements indefinite. These are summarised in the table below.
Table 7: potential benefits highlighted by supporters
Theme | Number of respondents |
---|---|
Improvement to patient safety | 9 |
Clear and robust regulations | 4 |
The need for improvements to patient safety following an indefinite implementation of a ban were particularly emphasised by clinicians, while pharmacists tended to highlight the opportunity to provide clear and robust regulations.
Respondents with neutral views to a potential implementation of an indefinite order also highlighted the same 2 themes as the supporters.
Three of the respondents who oppose a ban identified these benefits in making the arrangements indefinite:
- limiting unsafe prescribing while further research is collected
- providing clarity to GPs on their role in prescribing puberty blockers
- providing the opportunity to gather evidence from a trial
Both supporters and opponents were interested in the clinical trial, and specifically as to how the results of the trial might impact or amend an indefinite order.
Risks
Question: In your experience, are there risks in making the arrangements permanent?
The results to this question from the respondents were:
- 41 said yes
- 5 said no
- 3 said they didn’t know
- 2 gave no response
In summary, 41 of the 51 respondents believe there are risks in making the arrangements indefinite.
A common theme mentioned by both respondents who support and those who oppose a ban is the potential risk that patients would seek unregulated alternative products. This was raised by 4 supporters of a ban and 12 opponents.
Two respondents who support a ban also raised the concern for an unmet demand for gender services. This theme was supported by one neutral respondent, who mentioned the potential lack of appropriate referral pathways. Two neutral respondents and 4 opponents raised a potential concern for NHS capacity or expertise to support this cohort.
A common theme illustrated by neutral respondents and opponents of a ban is a worry that the risk of criminal sanctions may impact communication between medical professionals and patients. This was raised by 5 opponents and one neutral respondent. Concern for criminalisation charges for GPs and pharmacists was raised by a further 2 neutral respondents.
Other themes were that an indefinite ban poses a risk to negatively impact mental health, and that additional support for NHS staff may be required. These themes were raised by 13 opponents and 2 neutral respondents respectively.
Impacts on protected groups
Question: Do you think the accompanying equality impact assessment (EQIA) appropriately reflects the potential impact on protected groups which might arise from the proposal to make the order permanent?
The results to this question from the respondents were:
- 10 said yes
- 25 said no
- 11 said they didn’t know
- 5 gave no response
Question: Do you have any further comments or evidence about the potential impact on protected groups?
The main theme illustrated by respondents is that an indefinite ban would disproportionately affect transgender young people. Some respondents highlighted that the impact on young people from lower income families has not been considered.
For respondents in Northern Ireland only
Question: To what extent do you agree or disagree that the proposal to make the order permanent risks impacting people differently with reference to their protected characteristics, as covered by the public sector equality duty set out in section 75 of the Northern Ireland Act 1998?
The results to this question from the respondents were:
- 6 strongly agreed
- none agreed
- 2 neither agreed nor disagreed
- 1 disagreed
- 1 strongly disagreed
- 32 said it wasn’t applicable
- 9 gave no response
Six out of 51 respondents were from Northern Ireland specifically, and 18 respondents were UK-wide organisations.
Additional evidence
Question: If you have any additional evidence (including clinical or patient feedback) you wish to provide, please outline it here.
Respondents provided anecdotal evidence of the impact of the current order, and potential impact of an indefinite order, and correspondence from overseas prescribers highlighting what they felt were unsafe prescribing practices based on limited consultation with patients.
Respondents also referenced academic studies from peer-reviewed and non-peer reviewed journals.
Data sharing
Question: In the future, would your organisation be willing to share data, such as the volume of service users and their ages, to support policy making?
The results to this question from the respondents were:
- 15 said yes
- 8 said no
- 19 said they didn’t know
The available data in this space is limited. Current and reliable prescribing and demographic information is restricted to data available from the NHS. For policy making in this space to be improved in future, access to data and information held by private prescribers and organisations would be beneficial.
Responses to the question varied, with a majority of respondents answering, ‘don’t know’ (driven by those advising they did not hold any relevant data, and those who would want further information and reassurances around anonymisation before sharing).
The Secretary of State for Health and Social Care and the Minister of Health for Northern Ireland will continue to explore opportunities to access and use more data to better understand the demographic and spread of those affected by these issues in order to provide better care and targeted support.
Commission on Human Medicines
The Secretary of State for Health and Social Care and the Minister of Health for Northern Ireland jointly consulted the Commission on Human Medicines (CHM) on these proposals, as is required in legislation, for their independent expert view.
CHM advises ministers on the quality, safety and efficacy of medicinal products (medicines). More information on CHM can be found at the above link.
All written responses from consultees were sent to CHM for consideration when preparing their advice, and all consultees were given the opportunity to make in person representations to CHM to share their views on the proposal.
In total, 9 of the organisations and academics contacted for this consultation made representations to CHM to provide their views in addition to their written responses to the consultation.
CHM also met with consultant paediatric endocrinologists who work with children and young people on a daily basis, including experience of considering prescribing of puberty blockers, for their expert view on the proposal.
They also sought the views of Baroness Hilary Cass, Professor Emily Simonoff, and Professor Jane Hewitt who were able to provide insight into existing clinical evidence and the academic landscape regarding puberty blockers.
CHM has made 8 recommendations.
CHM recommendations in respect of the order
Recommendation 1
The current prescribing and care pathway for GnRH agonists for gender incongruence and/or gender dysphoria presents an unacceptable safety risk for children and young people under 18 years without significant additional safeguards, including those detailed in the 2 recommendations below. The current restrictions that are set out in the temporary prohibition order should continue indefinitely for prescribers registered outside the UK.
Recommendation 2
For UK private prescribers, the current restrictions that are in the temporary prohibition order should continue and there should be a review of the order in April 2027 and if required, at a later appropriate date, but no later than the end of the puberty suppressing hormone trial.
When reviewing the order, the Secretary of State for Health and Social Care and the Minister of Health for Northern Ireland should assess whether and how the evidence and safety environment have evolved, including whether the additional safeguards set out in recommendation 3 have been put in place.
The purpose of the assessment should be to consider whether at that point, GnRH agonists could be considered to have a safety profile that would enable them to be prescribed off label by competent clinicians working to common minimum care standards within an appropriate governance and multidisciplinary framework in the UK.
Recommendation 3
The additional safeguards which should be put in place to facilitate safe UK prescribing of GnRH agonists for gender incongruence and/or gender dysphoria outside the puberty suppressing hormone trial include:
- a) prescribers should complete a risk acknowledgment form with the patient and/or parents or carers when prescribing GnRH agonists for puberty suppression in children and young people under 18 years of age. This form should be identical across the UK’s 4 nations. CHM recommends that the Secretary of State for Health and Social Care and the Minister of Health for Northern Ireland should ask prescribers to do this and should write to their counterparts in Wales and Scotland asking them to do the same
- b) it is important that a set of consistently audited common care standards for specialist gender services is developed for children and young people under 18 years of age, adopted and implemented for use in all parts of the UK by April 2027, in both public and private sectors, and adherence regularly assessed by the healthcare regulators. CHM recommends that the Secretary of State for Health and Social Care and the Minister of Health for Northern Ireland collaborate with their counterparts in Wales and Scotland on how to do this
- c) there is an absence of long term safety and efficacy data for this population. DHSC should facilitate the development of a funded strategy for capturing and reporting long term safety and efficacy data across all UK gender specialist services. All children and young people who were prescribed GnRH agonists at the time of the temporary ban coming into place should be given the opportunity to participate in and co-design the studies
CHM recommendations in respect of wider implementation considerations
Recommendation 4
Mental health and wellbeing support for all children and young people with gender incongruence and/or gender dysphoria should be expedited and enhanced, irrespective of whether the prohibition order is made permanent or not.
Recommendation 5
We have noted the reports that an unknown number of children and young people have been unable to find an NHS prescriber willing to manage prescribing of their GnRH agonists, where the prescribing had previously been by an EEA prescriber. Through the planned communication strategy (see recommendation 8), such young people should be invited to present to the NHS, through whichever route, and the NHS should ensure that they receive appropriate rapid specialist assessment of their needs, and access to other support as required. Where a decision is made to continue regularly prescribed GnRH agonists in these legacy individuals, this should be undertaken by specialist gender services.
Recommendation 6
Those children and young people identified within recommendation 5 represent a vulnerable at-risk population. There should be an accelerated mental health service triage made available for all those children and young people aged under 18 who have experienced withdrawal of GnRH agonist treatment for puberty suppression as a direct result of the prohibition order.
Recommendation 7
The planned puberty suppressing hormone trial will recruit children and young people under 18 years who have not had previous exposure to GnRH agonists. A clear exit strategy needs to be put into place for continuation of GnRH agonists when exiting the trial if this is the pathway agreed with the patient and/or parents or carers. This should be accompanied by data collection on the efficacy and safety of the GnRH agonists.
Recommendation 8
An ongoing co-produced patient and/or parents or carers, and GP communication strategy should be prepared by DHSC working in collaboration with the four UK health services. This should include a plan detailing the timetable for enacting all the accepted CHM recommendations. The importance of further research in this area to understand the long-term efficacy and safety of the GnRH agonists should also be included in the communications plan.
Ministers’ position
The Secretary of State for Health and Social Care and the Minister of Health for Northern Ireland set out below how they will respond to these recommendations.
Introduction
The Secretary of State for Health and Social Care and the Minister of Health for Northern Ireland (‘the ministers’) are grateful to all of those who took the time to engage with and respond to the consultation, and those who made representations to CHM.
The ministers also wish to thank the members of CHM for their work and recommendations in this sensitive area.
Ministers understand that this is an area of policy where the public has a wide range of views. They firmly believe that policy making in this space should always be led by the evidence, with the aim of ensuring that children and young people who are experiencing gender incongruence and/or gender dysphoria receive a high standard of care that meets their needs and is safe, holistic and effective.
CHM recommendations
Ministers agree with the recommendation made by CHM in respect of the proposal to make the arrangement in the current section 62 order indefinite (recommendation 1).
This decision has been made jointly by the Secretary of State for Health and Social Care and the Minister of Health for Northern Ireland with Executive approval. The indefinite order, the Medicines (Gonadotrophin-Releasing Hormone Analogues) (Restrictions on Private Sales and Supplies) Order 2024, will apply from 1 January 2025.
Ministers agree with CHM’s conclusion that the current prescribing and care pathway for GnRH agonists for gender incongruence and/or gender dysphoria represents an unacceptable safety risk for children and young people under 18 years without significant additional safeguards in respect of UK private and EEA prescribing, and the current restrictions will therefore continue.
Ministers agree with CHM’s recommendation to review the order and progress against its other recommendations (recommendation 2), and have made a commitment in the proposed indefinite legislation to publish a report of that review in October 2027.
CHM has set out recommendations to address the risks to safety and limitations in evidence in the prescribing environment and government will take forward work on these (recommendations 3a, 3b and 3c).
Ministers agree with CHM that developing a clear standards framework for gender identity services, which can evolve as the evidence base builds, is an essential pre-requisite for regulators to be able to take necessary action against unsafe practice, whether in the public or private sector.
However, while the specific actions identified by CHM relating to risk assessment and standard setting (recommendations 3a and 3b) are routine in circumstances where medicines are being used in accordance with their licensed indications, and the evidence base for the proposed care is robust, they have not been used in relation to off-label prescribing or where the evidence base is weak.
Ministers will therefore be working with the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and professional and service regulators to establish how these mechanisms can be adopted in ways which will evolve as the evidence base grows.
The risk acknowledgement form (RAF) (recommendation 3a) is a safety mechanism that can be used in relation to safety concerns raised for a medicine’s licensed indication. Ministers have asked MHRA to consider how they can support safe prescribing.
With regard to standards (recommendation 3b), ministers have asked NICE to develop a quality standard for specialist gender identity services. NICE develops quality standards for the NHS that provide a concise, evidence-based description of high-quality care in a defined clinical area. Ministers also commit to closer collaboration with the devolved governments, while recognising devolved responsibilities for the provision of high-quality, evidence-based care. This collaboration would include opportunities for shared learning.
With regard to data and research (recommendation 3c), DHSC will work with the devolved governments to explore how best to monitor safety and efficacy data across UK gender specialist services. A consistent core data set has already been agreed and is being collected across new NHS specialised gender services in England.
With regard to support for those affected by the current order (recommendations 4, 5 and 6), NHS England will extend the current offer of a prioritised assessment by local NHS mental health services for those who are not on the waiting list of the children and young people’s gender service.
In addition, NHS England will continue to expand the number of specialist children and young people’s gender services. In April, NHS England opened 2 new services in London and the North West (Manchester). In November, a third service opened in the South West (Bristol). These services offer a fundamentally different clinical model, embedding multidisciplinary teams in specialist children’s hospitals. A fourth service is planned to open, in the East of England, in spring 2025 and NHS England’s plan is for there to be a specialist gender service for children and young people in each of the 7 NHS regions by 2026.
Ministers recognise the wait times for access to both gender and mental health services under the NHS are too long. The work being done by NHS England to introduce the new regional services will reduce those wait times significantly over the next 3 years.
On the trial exit strategy (recommendation 7), the planned study, which forms part of a wider research programme, is currently progressing through review and approval stages, including peer review and ethical approval. Confirmation of an exit strategy for the clinical management of children is a normal part of trial design and will be considered as part of the ethical approval process.
On a communications strategy (recommendation 8), ministers agree with this approach, and will be collaborating across the 4 UK health services to take this forward.
Penalties for breaching the order
Concerns were raised in the consultation on the potential criminalising of healthcare professionals who may dispense puberty blockers incorrectly or after being misled.
As with all prescribing and dispensing, healthcare professionals should take care to ensure they are following all rules and legislation.
As with all such cases, criminal sanctions or fitness to practise concerns surrounding the supply in contravention of this legislation will be considered on a proportionate, case-by-case basis by enforcement authorities (for the former) and the General Pharmaceutical Council (GPhC) for the latter.
Safety of these medicines
Some respondents highlighted an apparent disparity in puberty blockers being deemed safe to treat precocious puberty but not gender incongruence and/or gender dysphoria. While the medicine may be the same, they have not been licensed (which includes a process of robust assessment of safety and efficacy data) for gender incongruence and/or gender dysphoria, which means the safety and risk implications in that context have not been assessed formally by MHRA.
In addition, the 2 indications are dissimilar, with different age profiles, duration of treatment, co-morbidities, and balance of risks and benefits, all of which do not yet have clinically supported evidence for the indication of gender incongruence and/or gender dysphoria.
Conclusion
In making these decisions, ministers have carefully considered the responses received to this consultation, and the views of CHM.
Ministers recognise that an indefinite order of this nature is an unusual measure to ensure safe and effective healthcare for children and young people. Ministers hope that, in future, care and prescribing can be managed in accordance with treatment for children and young people in other areas of the health and care system, drawing on a robust evidence base and without the need for legislation.
Unfortunately, as seen in responses to the consultation, there is evidence of persistent unsafe prescribing practices regarding these medicines. Ministers have therefore concluded that legislation to prevent prescribing of GnRH agonists for gender incongruence and/or gender dysphoria in respect of UK private or overseas prescribing is justified to ensure the safety of children and young people.
As set out in the Cass Review, and agreed by CHM, there is a clear lack of clinical evidence for the safety and efficacy of using puberty blockers for gender incongruence and/or dysphoria in under 18s. Additionally 41.2% of all respondents also agreed that there was a limited evidence base upon which to base prescribing decisions.
In partnership with the National Institute for Health and Care Research (NIHR), NHS England is launching a clinical trial to assess the potential benefits and harms of puberty suppressing hormones.
Within this trial, the effects of puberty blockers can be safely monitored, and the research will give government and the NHS the evidence needed to decide whether they can be used as a safe and effective treatment. The trial aims to begin recruiting participants early in2025.
Support and advice
The government recognises that the introduction of a permanent order may cause concern to individuals and families who are directly impacted.
If a young person has already taken these medicines or has been prescribed these medicines in the 6 months prior to 3 June 2024 in Great Britain (and 27 August in Northern Ireland), they can continue to do so, providing their prescription is now issued by a UK registered prescriber.
However, they and/or their families are strongly advised to meet with their prescribing clinician to fully understand the safety risks associated with GnRH analogues when prescribed for gender incongruence and/or gender dysphoria.
If a young person currently taking these medicines is unable to access further prescriptions from their usual provider, they should speak to their GP. For those patients from the EEA they can seek help from a UK private provider or see their GP.
The GP team should offer to see any young person who comes forward and assess whether a referral for the specialised service for children and young people with gender incongruence and/or gender dysphoria or for mental health support are required.
The continuation of puberty suppressing hormones can be considered where the GP feels competent to do so, and where confirmation that treatment had been underway in the 6-month period before 3 June 2024 in Great Britain (and 27 August in Northern Ireland) is available.
To ensure that support is available for any young people in England who are impacted by these restrictions, NHS England has extended their offer of a prioritised assessment by local NHS mental health services to children and young people in England who are not on the waiting list of the CYP Gender Service and whose access to puberty suppressing hormones may have been discontinued as a consequence of the legislation.
This support is available through a single point of contact (SPOC) for eligible young people. The SPOC can be contacted by email on [email protected] or by calling 0300 131 6775 and selecting option 3.
The SPOC will be supported by clinical nurse specialists with experience in providing advice to families with a child or young person with gender incongruence and/or gender dysphoria.
This offer will be in place until 31 March 2025.
NHS England will also continue to:
- provide all young people who are on the national waiting list for care in the new specialised service for children and young people with gender incongruence and/or gender dysphoria with access to mental health services if they or their parents feel that is needed
- ensure all GPs have clear information and guidance about their responsibilities to these young people and how best to support them and, where appropriate, refer them to specialist services
- ensure all children and young people’s mental health services are informed about the impacts that these restrictions might have and implications for their services, and the need to ensure that services are ready to receive any primary care referrals
- enable the NHS 111 service, which has provision to deal with urgent mental health need, to provide appropriate support and advice to callers who may be impacted by these restrictions
- keep patients, families and health services informed about these restrictions and the support available to those who need it, and act on feedback received. Additionally, arrangements are in place to support young people impacted by these restrictions in Scotland, Wales and Northern Ireland. See:
Support is available in Northern Ireland from both the child and adolescent mental health services (CAMHS) in each trust and Knowing our Identity (KOI) as the regional CAMHS gender service.
Together with NHS England, DHSC will work with patient groups to continue to monitor and understand the impacts of these restrictions and how the support available may need to continue to improve in future.
Annex A: list of consultees
The below sets out the organisations whose representative views were requested for the consultation.
Individuals’ names have not been provided to protect their identity. One organisation who did not provide a response also asked not to be identified in this list.
Royal colleges and professional bodies
Academy of Medical Royal Colleges (AoMRC)
Association of Clinical Psychologists
British Medical Association (BMA)
British Medical Association Northern Ireland
British Psychological Society (BPS)
British Society Paediatric Endocrinology and Diabetes (BSPED)
Care Quality Commission (CQC)
Children’s Commissioner for England
Children’s Commissioner for Wales
Community Pharmacy England (CPE)
Community Pharmacy Northern Ireland (CPNI)
Community Pharmacy Scotland (CPS)
Community Pharmacy Wales (CPW)
Company Chemists’ Association (CCA)
General Medical Council (GMC)
General Pharmaceutical Council (GPhC)
General Practitioners Committee UK
Healthcare Distribution Association (HAD)
Independent Healthcare Provider Network (IHPN)
Independent Pharmacies Association (IPA)
National Pharmacy Association (NPA)
Northern Ireland Commissioner for Children and Young People
Nursing and Midwifery Council (NMC)
Pharmaceutical Society NI (including Pharmacy Forum NI)
Royal College of General Practitioners Northern Ireland
Royal College of General Practitioners (RCGP)
Royal College of Nursing (RCN)
Royal College of Paediatrics and Child Health (RCPCH)
Royal College of Psychiatrists (RCPsych)
Royal Pharmaceutical Society (RPS)
The Cass Review
Policy and government
Alder Hey Children’s Hospital Trust
Belfast Health and Social Care Trust
Care Inspectorate Wales
Chief Pharmacist (England)
Chief Pharmacist (Northern Ireland)
Chief Pharmacist (Scotland)
Chief Pharmacist (Wales)
Great Ormond Street Hospital
Health and Social Care Northern Ireland (HSCNI)
Health Inspectorate Wales
Healthcare Improvement Scotland (HIS)
Llais
National LGBT+ Health Advisor
NHS England
NHS Scotland Health Boards
NHS Wales Joint Commissioning Committee
Academics who self-identified as members of the below academic institutions
Amsterdam University Medical Center
De Montfort University
Glasgow University
Global Banking School
Lancaster University
Oxford Brookes University
University of Birmingham
University of Oxford
LGBT+ and health-related voluntary community and social enterprise groups
Affirm NI
Bayswater Support Group
Belfast Butterfly Club
Belfast Trans Resource Centre
British Association of Gender Identity Specialists (BAGIS)
Cara Friend
Clinical Advisory Network on Sex and Gender (CAN-SG)
CliniQ
Complex Needs Consortium
Equality Network
Feminist Gender Equality Network (FGEN)
Focus The Identity Trust
Galop
Gender Essence Support Services
Gender Identity Liaison Group
Gendered Intelligence
Genspect
HERe NI
LGB Alliance
LGBT Consortium
LGBT Foundation
LGBT Health and Wellbeing
LGBT Hero
LGBT Youth Scotland
London Friend
Mams4trans
Mental Health Policy Group
Mermaids
Mermaids - Local NI group
Metro
MindOut
National LGBT Partnership
NHS Confederation
OUTpatients
Ozanne Foundation
Papyrus
Pink Therapy
QUB Gender Network
Rainbow Project
SAIL NI
Samaritans
Scottish Trans
Sex Matters
Spectra
Stonewall
Stonewall Scotland
Switchboard LGBT+
Terrence Higgins Trust
The Gender Identity Research and Education Society (GIRES)
The Integrated Psychology Clinic
The Kite Trust
The Proud Trust
Thoughtful Therapists
Trans Aid Cymru
Trans Learning Partnership
TransActual
TransForm Cymru
Transgender Trend
TransgenderNI
TransLucent
Transvision Cymru
Umbrella Cymru