Consultation outcome

Proposed changes to the availability of puberty blockers

Published 11 December 2024

Introduction

Gender incongruence and/or gender dysphoria are conditions where a person experiences discomfort or distress that is caused by a discrepancy between a person’s gender identity (how they see themselves regarding their gender) and that person’s natal sex (and the associated gender role and/or primary and secondary sex characteristics).

The independent review of gender identity services for children and young people (the Cass Review) considered the role of puberty blocking hormones in the treatment of children and young people experiencing gender incongruence and/or gender dysphoria. The interim report was published in February 2022. The final report of the Cass Review (‘the report’), published in April 2024, concluded that the rationale for early puberty suppression remains unclear, with weak evidence regarding the impact on 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.

As part of the consideration of evidence for a national clinical policy on puberty suppressing hormones, NHS England commissioned the National Institute for Health and Care Excellence (NICE) in October 2020 to conduct an evidence-based review into the use of puberty blockers and feminising and masculinising hormones as treatment for gender incongruence and/or gender dysphoria in children and young people. This work also informed the Cass Review, together with an independent systematic evidence review undertaken by York University. The national clinical policy was subject to a 90-day public consultation. The final policy, published in March 2024, sets out that gonadotrophin-releasing hormone (GnRH) analogues (referred to as puberty blockers in the treatment of young people, or puberty suppressing hormones, referred to as puberty blockers in this document) are no longer available as a routine commissioning treatment option for children and young people under 18 who have gender incongruence and/or gender dysphoria.

The Cass Review recommended that the Department of Health and Social Care should consider statutory solutions that would prevent inappropriate overseas prescribing, and define the dispensing responsibilities of pharmacists of private prescriptions. NHS England’s Medical Director of Specialised Services also raised concerns about use of unregulated medications and of providers that are not regulated within the UK .

In responding to this, we want to ensure that a consistent approach to the prescribing of puberty blockers is taken in all settings. We have particular concerns over the practices of overseas providers, not regulated in the UK, who rejected the Cass Review recommendations and continued to offer puberty blockers via prescriptions from European Economic Area (EEA) registered prescribers, which could then be dispensed in a UK pharmacy.

Safety concerns of serious danger to health were such that on 29 May 2024, the government introduced 2 pieces of legislation which restrict how children and young people under 18 years old can access GnRH analogues. These GnRH analogues consist of or contain:

• buserelin
• gonadorelin
• goserelin
• leuprorelin acetate
• nafarelin
• triptorelin

The first piece of legislation, the Medicines (Gonadotrophin-Releasing Hormone Analogues) (Emergency Prohibition) (England, Wales and Scotland) Order 2024 (‘the emergency order’), applies to England, Wales and Scotland. It is a 3-month emergency order, which:

• banned the sale or supply of the listed medicines prescribed by private UK registered prescribers for gender incongruence and/or gender dysphoria to under 18s not already taking them
• banned the sale and supply of these medicines against prescriptions from prescribers registered in the EEA or Switzerland for any purpose to those under 18

The emergency order came into force from 3 June 2024 in Great Britain and expires on 2 September 2024.

A second emergency order will be developed and introduced. This will continue current restrictions and allow time for this consultation to take place ensuring the is no gap in legislative provision.

Human medicines and healthcare are transferred matters in respect of Northern Ireland. We are engaging with the Northern Ireland Executive, including on whether any future order should apply across the United Kingdom.

A separate set of regulations restricts NHS primary care prescribing of puberty blockers to use only in specific circumstances, and do not have an expiry date. The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2024 apply to England only.

The National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) (Amendment) Regulations 2024 apply to Wales.

Equivalent regulations for Scotland are due to commence in early September 2024.

Equivalent amendments to the Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004 are still being considered.

This consultation seeks views on the proposal to make a permanent order to come into force when the emergency order expires. The proposed permanent order would apply to the medicines listed above that are covered by the current restrictions.

A marketing authorisation, or licence, is granted to medicines that meet the standards of safety, quality and efficacy set by the Medicines and Healthcare products Regulatory Agency. These medicines have been used to treat patients with gender incongruence and/or gender dysphoria, as well as a range of other conditions covered by their marketing authorisation, or which are deemed clinically suitable for off-label use. When these medicines are being used as puberty blockers to treat gender incongruence and/or gender dysphoria they are being used off label. Off label means a medicine is used in a different way than that stated in its licence. This could mean using the medicine for a different condition or a different group of patients, for example.

It is proposed that the sale or supply of these items for this off-label purpose should be restricted permanently. We propose that as with the emergency order, in the case of UK private prescribers the order will only apply to the treatment of gender incongruence and/or gender dysphoria, and for all uses for those under 18 with a prescription from an EEA or Swiss registered prescriber.

We invite comments on these proposals and responses to the consultation questions set out in this document. The consultation will last for 6 weeks and target representative groups of those most likely to be affected by a potential order. This includes the royal colleges, professional bodies, regulators, academics and voluntary, community and social enterprises representing patients, prescribers, pharmacists and others. See the ‘How to respond’ section for the full list.

We are consulting with representative groups in line with legislative requirements. This consultation also builds on the extensive consultation undertaken for the Cass Review and previous NHS England consultations. As such the questions focus on the impact of the proposed permanent order, and the benefits and risks of making such an order permanent.

This is not a public consultation. You should only provide one response per organisation. Do not include any information that could identify you, or anyone else, in your answers to the consultation questions. Any personally identifiable information entered won’t be used and will be deleted.

We encourage you to seek the views of your members, but please note that only the response from your organisation, as a representative body, will be considered. Responses from individuals that are not made on behalf of representative bodies will not be considered as part of this consultation process.

If you require this document in the Welsh language, this is available on request from [email protected].

Policy background

There is a wide range of evidence that has informed the decision to consult on a permanent mechanism to restrict the supply of puberty blocker medicines to children under the age of 18 when these medicines are prescribed by UK private prescribers and prescribers registered in the EEA or Switzerland. 

In September 2020, NHS England commissioned an independent and wide-ranging review of gender identity services for children and young people to be led by Dr Hilary Cass, former president of the Royal College of Paediatrics and Child Health. This was driven by long waiting lists at Tavistock Gender Identity Development Service (GIDS) and whistleblowing reports about this service adopting a predominantly medicalising approach for treating gender incongruence and/or gender dysphoria. The Care Quality Commission (CQC) later published a report on Tavistock and Portman Foundation Trust’s clinic and rated it as inadequate. 

As part of developing a national clinical policy, NHS England commissioned NICE in October 2020 to conduct an evidence-based review into the use of GnRH analogues (puberty blockers) and feminising and masculinising hormones as treatment for gender incongruence and/or gender dysphoria in children and young people. This review found puberty blockers to have no statistically significant impact on gender incongruence and/or gender dysphoria, mental health, body image and psychosocial functioning in children and adolescents. NICE found the quality of evidence for all these outcomes to be low and noted that GnRH analogues may reduce the expected increase in lumbar or femoral bone density during puberty.

In February 2022 the Cass Review published an interim report. The report noted that a single specialist provider model was not a safe or viable long term option. It therefore recommended that the Tavistock GIDS be brought to a managed close and that regional centres providing a holistic model of care centred on psychological and psychosocial support be developed as soon as possible. The report also detailed concerns about the lack of evidence on which many interventions are provided (in particular, puberty blockers), emphasising that further research is needed to before clear recommendations can be made.

In April 2023, NHS England updated NICE’s 2020 evidence review into puberty blockers, identifying 9 further studies to be considered. The updated study reached a similar conclusion - since all the included studies lacked appropriate controls, the outcomes were not considered to be statistically significant. NHS England therefore took the decision that there is not enough evidence to support the safety or clinical effectiveness of puberty blockers to make the treatment routinely available. A new policy banning any new routine prescription of puberty blockers as treatment for gender incongruence and/or gender dysphoria was issued by NHS England in March 2024, following a 90-day public consultation.

In April 2024, the Cass Review final report was published. The final report concluded that there was insufficient and/or inconsistent evidence about the effects of puberty suppression on psychological or psychosocial health, and that blocking hormonal surges might dampen distress in the short term but might not be an appropriate response to pubertal discomfort. It also found that use of puberty blockers in these circumstances blocks the normal rise in hormones that should occur into teenage years, and which is essential for psychosexual and other physical developmental processes such as brain and cognitive development and bone health. It also has implications for fertility, and the use of puberty blockers may also reduce psychological functioning. In terms of supporting transition, if puberty suppression is started too early in birth-registered males it can make subsequent vaginoplasty more difficult due to inadequate penile growth.

Given the limited evidence, complex case management and issues around child competence to consent to treatment with significant long-term implications, the Cass Review recommends that every case considered for medical treatment should be discussed at a national multi-disciplinary team (a group of specialised health and care staff who are members of different organisations and professions, that work together to make decisions regarding the treatment of individual patients and service users). This cannot happen outside the NHS or outside a clinical trial. To that end, the government is committed to a renewed focus on building better quality evidence, including supporting NHS England to set up a clinical trial as soon as possible where young people can access puberty blockers in a safe and controlled environment, with continuous assessment from doctors.

The Cass Review was informed by a large range of sources, including extensive stakeholder engagement with those with ‘lived experience’ and comprehensive systematic analyses conducted by the University of York. The findings of the review have mostly been met positively by the medical community. Based on the review, the Royal College of General Practitioners have, for example, issued clear advice to GPs that unless they have particular expertise or an extended role in transgender care, their role does not include prescribing puberty blockers for a patient aged under 18, given the concerns about the evidence base in this area, noting that clinical support for gender incongruence and/or gender dysphoria is a specialist service.

In contrast, in the wake of the report publication, some international providers stated their intention to continue prescribing puberty blockers to children in the UK, thus the risk to these children is high.

Following the publication of the report, the government introduced restrictions to the prescribing of these medicines to new patients under 18 for the purposes of gender incongruence and/or gender dysphoria within NHS primary care in England, as set out in the National Health Service (General Medical Service Contracts) (Prescription of Drugs etc.) Regulations 2004.

As set out in the introduction above, a second emergency order will be developed and introduced that will continue current restrictions and allow time for this consultation to take place ensuring there is no gap in legislative provision.

The impact of the emergency order

Data and evidence to help us understand the effect and implications of the existing temporary order are limited. Due to the length of time the order has been in place and limitations with data on private prescribing, robust evidence is unlikely to be available for some time. We continue to engage with NHS England, the royal colleges, the Care Quality Commission, the General Medical Council and pharmaceutical bodies to understand the impact of the order. The Secretary of State has also met with LGBT+ stakeholders and other stakeholders who will have an interest in the decision to consider a permanent order.

Clinical and professional stakeholders with whom we have engaged have not reported operational issues regarding the order. Some have reported varying levels of awareness among health professionals of the order, the requirements it makes of them, and the support available for children and young people impacted by the order. Stakeholders have stressed the importance of ensuring that children and young people impacted by the order can access appropriate support.

The Department of Health and Social Care (DHSC) has received a small number of letters from parents of children who have been receiving puberty blockers via an EEA registered prescriber and whose GP was unwilling to continue prescribing, as well as expressing fears of existing UK private prescriptions ceasing.

Support available to those impacted by the potential permanent order

The government recognises that the introduction of a permanent order may cause concern to individuals and families who are directly impacted, who have been taking or had expectations of taking these medicines.

If a young person has already taken these medicines or has been prescribed these medicines in the 6 months prior to 3 June 2024, 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 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 is available. Clinical advice to NHS England is that these medicines can be stopped without significant impact on endocrinology and they can be stopped without the need of any endocrine follow up; however, a patient is likely to need support to manage the psychological impact of stopping a treatment.

To ensure that support is available for any young people in England who are impacted by these restrictions, NHS England has and will 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 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 service 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

Equivalent arrangements are in place to support young people impacted by these restrictions in Scotland, Wales and Northern Ireland. See:

• restrictions on puberty suppressing hormones in Scotland
• changes to prescribing GnRH analogues in Wales

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.

Alongside this, NHS England will continue to expand new service provision, following on from the opening of 2 new services on 1 April 2024, CYP Gender Service (London) and CYP Gender Service (North West). A third new service will become operational in November 2024 at University Hospital Bristol and Weston NHS Foundation Trust; and it is anticipated that Cambridge University Hospitals NHS Foundation Trust will open its service in April 2025. NHS England’s planning assumption is for there to be a specialist gender service for children and young people in each of the 7 NHS regions by 2026 to 2027.

If someone is no longer taking these medicines due to the existing order, they are advised to discuss their next steps with their GP. If their mental health is being affected, they may want to seek support. If they are under the care of an NHS mental health service, they should contact their team. If not, they can contact their GP practice. See NHS advice on getting mental health support for children and young people.

If they need support because they are waiting to be seen by the NHS England specialised service for children and young people with gender incongruence, support options can be found on the website for the National Referral Support Service.

The NHS gives advice on where to get urgent help for mental health, including calling NHS 111.

How the restrictions take effect

The intention of the potential permanent order, combined with the regulations mentioned above, is to prevent the sale or supply of puberty blockers to new patients aged under 18 for the purposes of gender incongruence and/or gender dysphoria, outside of the supervision of the national multi-disciplinary team or a clinical trial overseen by the National Institute for Health and Care Research (NIHR). The approach as it relates to patients, the sale and supply of puberty blockers, and dispensing pharmacists is set out below.

For patients

If the patient receives puberty blocker prescriptions from a UK registered prescriber, they will only be able to have them dispensed if any of these statements is true:

• they are under 18 years of age and have started treatment with these medicines for the purposes of gender incongruence and/or gender dysphoria on any occasion before 3 June 2024. The prescription has to be annotated with ‘SLS’ (Selected List Scheme) and age, unless issued before 3 June 2024, in which case proof of age and ID is required
• they are under 18 years of age and are being prescribed these medicines for a reason other than for gender incongruence and/or gender dysphoria (for example, precocious puberty). The prescription has to be annotated with ‘SLS’ and age, unless issued before 3 June 2024, in which case proof of age and ID is required
• they are 18 years or above. In the case of private prescriptions issued by UK prescribers, a sale or supply to a person who is 18 or over is excepted, provided that the prescription is annotated with ‘SLS’ and the person’s age, or they provide proof of age and identity at the point of sale or supply

If the patient receives puberty blocker prescriptions from an EEA or Swiss registered prescriber:

• if they are under 18 years of age they will no longer be able to have them dispensed for any reason. If the prescription was issued before 3 June 2024 (Great Britain) then it can be dispensed
• if they are 18 years of age or over they can continue to use these prescriptions. In the case of private prescriptions issued by prescribers in the EEA and Switzerland, a sale or supply to a person who is aged 18 or over is excepted, provided that the person provides proof of age and identity at the point of sale or supply

If they are a patient under 18 who has been receiving prescriptions from EEA or Swiss registered prescribers, and have been affected by the current emergency legislation, they can contact their GP or NHS 111 to receive support and advice on their care.

Sale and supply of puberty blockers in the UK

From 3 June 2024 in Great Britain, prescriptions for puberty blockers issued by UK registered prescribers will only be able to be dispensed, or continue to be dispensed in any of the following circumstances:

• the patient is aged 18 years or over
• the patient is under the age of 18 and has started treatment with these medicines on any occasion before 3 June 2024 in Great Britain (even if they have not yet actually started to take the medicine)
• the patient is under the age of 18 and is being treated with puberty blockers for gender incongruence and/or gender dysphoria as part of a future clinical trial overseen by NIHR or national multi-disciplinary team
• the patient is under the age of 18 and the purpose of the prescription is for a medical condition other than gender incongruence and/or gender dysphoria (for example, precocious puberty)

From 3 June 2024, private prescriptions for puberty blockers issued by that date by EEA or Switzerland registered prescribers will only be able to be dispensed in the following circumstances:

• the patient is 18 years or older

In the case of prescriptions issued by UK registered prescribers, a sale or supply to a person who is 18 or over is excepted, provided that the prescription is annotated with ‘SLS’ and the person’s age, or they provide proof of age and identity at the point of sale or supply. In the case of private prescriptions issued by prescribers in the EEA and Switzerland, a sale or supply to a person who is aged 18 or over is excepted, provided that the person provides proof of age and identity at the point of sale or supply.

For dispensing pharmacists

Prescriptions from UK registered prescribers dated 3 June 2024 or later for puberty blockers should only be dispensed:

• if the patient is under 18, if the endorsement ‘SLS’ and the patient’s date of birth is present
• if the patient is 18 or over, the prescription is endorsed ‘SLS’ or the patient can confirm their age and identity on production of appropriate ID

Prescriptions from EEA or Swiss registered pharmacists for these medicines are only valid if the patient is 18 or over. Supply to patients aged under 18 against a prescription from an EEA or Swiss registered prescriber for these medicines is prohibited.

Table 1: permitted prescriptions of puberty blockers (GnRH analogues)

New patients are those who:

• have not previously been treated with GnRH analogues
• have not received a prescription for GnRH analogues in the period since 3 December 2023 in Great Britain
• have received a prescription after 3 June 2024 in Great Britain from a UK private prescriber, or after 26 June 2024 from an NHS prescriber

	NHS secondary care prescriber	NHS primary care prescriber	UK private prescriber	EEA prescriber
Existing and new patients aged 18 and over	Yes	Yes	Yes	Yes, with proof of age
Existing and new patients under 18 for purposes other than gender incongruence and/or gender dysphoria	Yes	Yes	Yes	No
Existing patients under 18 for gender incongruence and/or gender dysphoria	Yes	Yes	Yes	No
Participants in a clinical trial aged under 18	Yes	Yes	Yes	No
New patients under 18 for gender incongruence and/or gender dysphoria	Yes	No (see note)	No	No

Note: with regards NHS primary care prescriber in Northern Ireland, equivalent amendments to the Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004 are still being considered.

Sanctions, penalties and enforcement

Breach of the emergency order is a criminal offence under the Medicines Act 1968.

It is a criminal offence to supply these medicines outside the terms of the emergency order. This means that pharmacists who dispense medicines against prescriptions that are not valid may be liable to criminal prosecution.

It is a criminal offence to possess these medicines, where the individual had reasonable cause to know that the medicine had been sold or supplied in breach of the terms of the emergency order.

A person guilty of breaching the emergency order is liable on summary conviction to a fine of up to £400, or on conviction on indictment to an unlimited fine and/or to imprisonment for a term of up to 2 years.

In addition, breaching the order would provide the relevant regulator with evidence to consider as part of the fitness to practise process. Criminal sanctions, if imposed by the criminal justice system, or fitness to practise concerns surrounding the supply, will be considered on a proportionate, case-by-case basis by the General Pharmaceutical Council (GPhC). The GPhC, in accordance with standard practice, will consider the use of interim powers where necessary for the protection of the public or where it is in the public interest.

The same sanctions, penalties and enforcement would apply if a permanent order was introduced.

Benefits and challenges

The findings of the Cass Review, and the work of NHS England and NICE have all been considered when assessing the benefits and challenges of making permanent the proposed changes for puberty blockers.

The benefits of the proposal are to:

• prevent inappropriate or unsafe prescribing to children and young people in any setting, safeguarding their welfare by reducing the clinical risk for children and young people using EEA registered prescribers to obtain puberty blockers in the UK, and those who would otherwise seek to do so via this route
• reduce the clinical risk for children seeking to use NHS or UK private prescribing to obtain puberty blockers for gender incongruence and/or gender dysphoria
• ensure that prescribing of puberty blockers for gender incongruence and/or gender dysphoria for children and young people under 18 is consistent, and to follow the recommendations of the Cass Review
• give clarity and certainty to patients and clinicians about the legal framework for prescribing and supply of these medicines
• develop the potential for health gains arising from more appropriate treatment being provided to children instead of puberty blockers

The challenges with the proposal are:

• risks to the mental health and wellbeing of children and young people with gender incongruence and/or gender dysphoria, if they were accessing these medicines and can no longer do so, or if they had an expectation of accessing them, and may require additional mental health or wider support as a result
• the risk that patients of any age who are prescribed these medicines for reasons other than gender incongruence and/or gender dysphoria (that is for their licensed indications or other off-label uses) experience difficulties in securing supply
• a loss of perceived or actual clinical benefit arising from puberty blockers within the scope of the restrictions. Such benefits may or may not have a robust evidence base, but they may be seen as very beneficial by those using them
• a potential increase in demand for NHS care, and associated risk of patients experiencing a delay or difficulty in seeking NHS care if they previously used other routes the risk that the requirements on prescribers, dispensers, healthcare workers involved in patient support, or others are not sufficiently clear or practical
• the risk that pharmacists or patients are subject to criminal proceedings due to inadvertent error or breaches
• ongoing enforcement and monitoring costs for regulators and clinicians in ensuring the restrictions are properly applied
• a potential risk of patients seeking unsafe treatment and/or the creation of “black market” demand

Prevalence and treatments

The proposed permanent order would apply to the medicines listed in Appendix A.

These medicines are safe and effective when prescribed for the clinical condition or indication for which they are licensed or authorised by the Medicines and Healthcare products Regulatory Agency.

Up to 80,000 NHS prescriptions are issued every year for these medicines. Nearly all of these are for adults, relating to conditions which include certain cancers. A very small number of children may also be prescribed these medicines for conditions including precocious puberty and certain height disorders.

Internal data for 2023 to 2024 from the NHS Business Services Authority suggests that around 600 patients under 18 had prescriptions for puberty blockers dispensed in the community.  

Secondary care figures were much lower and community dispensing accounts for around 90% of dispensing for these products in this age group. It is not known what condition these medicines were prescribed for but based on an analysis of prevalence of other conditions such as precocious puberty, we estimate that around 350 children are currently prescribed puberty blockers by the NHS for gender incongruence and/or gender dysphoria. This estimate is tentative.

Internal data on private sector prescribing and prescribing by EEA registered prescribers is very limited and uncertain. DHSC hopes to develop estimates of the numbers of prescriptions of GnRH analogues for 0 to 17 year olds issued annually through private or EEA routes, in the light of consultation responses. More precise data is not currently available.

How to respond

This is a targeted consultation of representative groups which will last for 7 weeks and close at 11:59pm on 8 October 2024.

The consultation will consider responses from representative groups of:

• patients and their families
• associated charities and voluntary and community organisations clinicians
• clinicians (such as medical doctors, psychiatrists and psychologists)
• prescribers
• pharmacists
• regulators
• academics and researchers
• government

When responding please confirm your organisation only. Do not include personally identifiable information about yourself or anyone else.

The Commission on Human Medicines (CHM) is also being consulted on this potential legislation and will provide a report to the Secretary of State. The CHM advises ministers on the safety, efficacy and quality of medicinal products. Minsters are required to consult CHM when making legislation under the Medicines Act 1968.

Representative groups consulted in this process have the opportunity, should you wish, to make representations directly to the CHM, either in writing or orally (virtually via teams). All written responses to this consultation will be shared with the CHM by DHSC officials, and will be considered by CHM.

If you would like to additionally make a representation to the CHM orally, please contact [email protected] by 13 September 2024 and officials will arrange a time for you to meet with the CHM in the first 3 weeks of October 2024.

This meeting will be virtual and you will have 30 minutes to make your representations to the CHM. This oral representation will be considered by the CHM in their report to the Secretary of State in addition to any written response to the consultation.

Consultation questions

We are proposing to make the arrangements set out in the emergency order permanent, pending the outcome of this consultation. If enacted, the effect of these changes would be that no new patients under 18 who are under the care of UK private prescribers and prescribers registered in the EEA or Switzerland will be prescribed these medicines for the purposes of puberty suppression in respect of gender incongruence and/or gender dysphoria (other than those exemptions set out previously in this document).

The list of medicines in scope is shown in Appendix A.

As highlighted previously, this is not a public consultation, and you should only provide one response per organisation to the below questions. Please do not include any personally identifiable information in your response.

We encourage you to seek the views of your members, but please note that only the response from your organisation, as a representative body, will be considered. Responses from individuals that are not made on behalf of representative bodies will not be considered as part of this consultation process.

Your organisation

Which type of organisation are you responding on behalf of?

• patients and their families
• associated charities and voluntary and community organisations clinicians
• clinicians (such as medical doctors, psychiatrists and psychologists)
• prescribers
• pharmacists
• regulators
• academics and researchers
• government

What is the name of your organisation?

The emergency order

To what extent do you agree or disagree with making the arrangements in the emergency order permanent? 

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree

Please explain your answer.

Positive impacts

In your experience, what have been the positive impacts of the emergency order?

Please provide evidence to support your answer.

Negative impacts

In your experience, what have been the negative impacts of the emergency order?

Please provide evidence to support your answer.

Benefits

In your experience, are there benefits in making the arrangements permanent?

• Yes
• No
• Don’t know

Please provide evidence to support your answer and explain how you think those benefits could be maximised?

Risks

In your experience, are there risks in making the arrangements permanent?

• Yes
• No
• Don’t know

Please provide evidence to support your answer and explain how you think those risks could be mitigated?

Impacts on protected groups

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?

• Yes
• No
• Don’t know

Do you have any further comments or evidence about the potential impact on protected groups? If yes, please specify.

For respondents in Northern Ireland only

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? 

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Not applicable

Please explain your answer.

Additional evidence

If you have any additional evidence (including clinical or patient feedback) you wish to provide, please outline it here.

Do not include any personally identifiable information.

Data gathering

The government is keen to improve the data it gathers in relation to how many children and young people are affected by the order, as well as the impact of the information and guidance provided to them.

If you have any thoughts on how this data could be gathered, please outline them here.

Data sharing

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?

• Yes
• No
• Don’t know

Please explain your answer.

Next steps 

The department will analyse the responses to this targeted consultation and in conjunction with the representations made to the CHM, provide advice to the Secretary of State for Health and Social Care and to the Minister of Health for Northern Ireland who will decide whether and how to implement the proposed changes. The outcome of the consultation will be published on GOV.UK.

Appendix A: list of puberty blockers (GnRH analogues) covered by current restrictions

The proposed permanent order would apply to medicines listed below. This includes, but is not limited to, medicines sold under the brand names listed.

The following puberty blockers (GnRH analogues) are covered by current restrictions:

• buserelin
• gonadorelin
• goserelin - Zoladex® and Zoladex LA®
• leuprorelin acetate - Prostap 3 DCS®, Prostap SR DCS® and Staladex®
• nafarelin
• triptorelin - Decapeptyl®, Gonapeptyl Depot® and Salvacyl®

Privacy notice

Summary of initiative or policy

Proposal to make a permanent order to prevent new patients aged under 18 from beginning to take puberty blockers for the purposes of gender incongruence and/or gender dysphoria, under the care of private prescribers. 

Data controller

The Department of Health and Social Care (DHSC) is the data controller.

What personal data we collect

We will only collect your email address if volunteered by you.

How we use your data (purposes)

We will use your email address to provide you with a reminder if you have not completed the survey once this has been started.

Legal basis for processing personal data

Under Article 6 of the United Kingdom General Data Protection Regulation (UK GDPR), the lawful basis we rely on for processing this personal data is:

e) the processing is necessary to perform a task in the public interest or for our official functions and the task or function has a clear basis in law. This supports the Secretary of State’s duties in relation to the promotion and provision of a comprehensive health service, as outlined in the NHS Act 2006 and Health and Social Care Act 2012

Data processors and other recipients of personal data

This consultation is hosted via an online platform owned by SocialOptic, who are a contracted supplier of DHSC. SocialOptic will delete any personal data in line with the retention and disposal periods outlined in this privacy notice, or earlier if instructed to do so by DHSC.

Anonymised and aggregated data will also be shared with the Commission on Human Medicines, who will be asked to provide a report to the Secretary of State.

International data transfers and storage locations

Storage of data by SocialOptic is provided via secure servers located in the UK. Storage of data by DHSC is provided via secure computing infrastructure on servers located in the European Economic Area. Our platforms are subject to extensive security protections and encryption measures.

Retention and disposal policy

Your response data will be held for up to 12 months from the closure of the consultation, it will then be deleted. If you wish to contact DHSC regarding your survey response, the email address you volunteered will be used to locate your response.

How we keep your data secure

In the first instance, your response data will be stored on SocialOptic secure UK-based server. Your personal data will be transferred to our secure government IT system as soon as possible.

Your rights as a data subject

By law, data subjects have a number of rights, and this processing does not take away or reduce these rights under the EU General Data Protection Regulation (2016/679) and the UK Data Protection Act 2018 applies.

These rights are:

• the right to get copies of information - individuals have the right to ask for a copy of any information about them that is used
• the right to get information corrected - individuals have the right to ask for any information held about them that they think is inaccurate, to be corrected
• the right to limit how the information is used - individuals have the right to ask for any of the information held about them to be restricted - for example, if they think inaccurate information is being used
• the right to object to the information being used - individuals can ask for any information held about them to not be used. However, this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case
• the right to get information deleted - this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case

Comments or complaints

Anyone unhappy or wishing to complain about how personal data is used as part of this programme should contact [email protected] in the first instance or write to:

Data Protection Officer
1st Floor North
39 Victoria Street
London
SW1H 0EU

Anyone who is still not satisfied can complain to the Information Commissioner’s Office.

Their postal address is:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Automated decision making or profiling

No decision will be made about individuals solely based on automated decision making (where a decision is taken about them using an electronic system without human involvement) which has a significant impact on them.

Changes to this policy

We keep this privacy notice under regular review, and we will update it if necessary. All updated versions will be marked by a change note on the consultation page. This privacy notice was last updated on 20 August 2024.