“Gender dysphoria in children, also known as gender identity disorder or gender incongruence of childhood (World Health Organisation 2020), refers to 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 sex assigned at birth and the associated gender role, and/or primary and secondary sex characteristics (Diagnostic and Statistical Manual of Mental Disorders 2013). GnRH analogues suppress puberty by delaying the development of secondary sexual characteristics. The intention is to alleviate the distress associated with the development of secondary sex characteristics, thereby providing a time for on-going discussion and exploration of gender identity before deciding whether to take less reversible steps. In England, the GnRH analogue triptorelin (a synthetic decapeptide analogue of natural GnRH, which has marketing authorisations for the treatment of prostate cancer, endometriosis and precocious puberty [onset before 8 years in girls and 10 years in boys]) is used for this purpose. The use of triptorelin for children and adolescents with gender dysphoria is off-label.”
“Service capacity and delivery 1.9. A rapid change in epidemiology and an increase in referrals means that the number of children seeking help from the NHS is now outstripping the capacity of the single national specialist service, the Gender Identity Development Service (GIDS) at The Tavistock and Portman NHS Foundation Trust. 1.10. The mix of young people presenting to the service is more complex than seen previously, with many being neurodiverse and/or having a wide range of psychosocial and mental health needs. The largest group currently comprises birth-registered females first presenting in adolescence with gender-related distress. 1.11. Until very recently, any local professional, including non-health professionals, could refer to GIDS, which has meant that the quality and appropriateness of referrals lacks consistency, and local service provision has remained patchy and scarce. 1.12. The staff working within the specialist service demonstrate a high level of commitment to the population they serve. However, the waiting list pressure and lack of consensus development on the clinical approach, combined with criticism of the service, have all resulted in rapid turnover of staff and inadequate capacity to deal with the increasing workload. Capacity constraints cannot be addressed through financial investment alone; there are some complex workforce (recruitment; retention; and training) and cultural issues to address. 1.13. Our initial work has indicated that many professionals working at primary and secondary level feel that they have the transferable skills and the commitment to offer more robust support to this group of children and young people, but are nervous about doing so, partly because of the lack of formal clinical guidance, and partly due to the broader societal context. 1.14. Primary and secondary care staff have told us that they feel under pressure to adopt an unquestioning affirmative approach and that this is at odds with the standard process of clinical assessment and diagnosis that they have been trained to undertake in all other clinical encounters. 1.15. Children and young people are waiting lengthy periods to access GIDS, during which time some may be at considerable risk. By the time they are seen, their distress may have worsened, and their mental health may have deteriorated. 1.16. Another significant issue raised with us is one of diagnostic overshadowing – many of the children and young people presenting have complex needs, but once they are identified as having gender-related distress, other important healthcare issues that would normally be managed by local services can sometimes be overlooked. 1.17. The current move to adult services at age 17-18 may fall at a critical time in the young person’s gender management. In contrast, young people with neurodiversity often remain under children’s services until age 19 and some other clinical services continue to mid-20s. Further consideration will be needed regarding the age of transfer to adult services. Service standards 1.18. The Multi-Professional Review Group (MPRG), set up by NHS England to ensure that procedures for assessment and for informed consent have been properly followed, has stated that the following areas require consideration: ● From the point of entry to GIDS there appears to be predominantly an affirmative, non-exploratory approach, often driven by child and parent expectations and the extent of social transition that has developed due to the delay in service provision. ● From documentation provided to the MPRG, there does not appear to be a standardised approach to assessment or progression through the process, which leads to potential gaps in necessary evidence and a lack of clarity. ● There is limited evidence of mental health or neurodevelopmental assessments being routinely documented, or of a discipline of formal diagnostic or psychological formulation. ● Of 44 submissions received by the MPRG, 31% were not initially assured due to lack of safeguarding information. And in a number of cases there were specific safeguarding concerns. There do not appear to be consistent processes in place to work with other agencies to identify children and young people and families who may be vulnerable, at risk and require safeguarding.”
“Given the particular uncertainties regarding long-term outcomes of medical intervention, and the broader knowledge gaps in this area, there is an imperative to build research capacity into the national network. This research capacity is needed to provide ongoing appraisal of new literature and rapid translation into clinical practice, to continue to identify areas of practice where further research is needed, and to develop a research portfolio that will inform policy on assessment, support and clinical care of children with gender dysphoria, from presentation through to appropriate social, psychological and medical management. As already highlighted in my interim report, the most significant knowledge gaps are in relation to treatment with puberty blockers, and the lack of clarity about whether the rationale for prescription is as an initial part of a transition pathway or as a ‘pause’ to allow more time for decision making. For those who will go on to have a stable binary trans identity, the ability to pass in later life is paramount, and many will decide that the trade-offs of medical treatment are a price that is fully justified by the ability to live confidently and comfortably in their identified gender. The widely understood challenge is in determining when a point of certainty about gender identity is reached in an adolescent who is in a state of developmental maturation, identity development and flux. It is the latter option regarding a ‘pause’ for decision making about which we have the least information. The rationale for use of puberty blockers at Tanner Stage 2 of development was based on data that demonstrated that children, particularly birth-registered boys who had early gender incongruence, were unlikely to desist once they reached early puberty; this rationale does not necessarily apply to later-presenting young people, including the predominant referral group of birth-registered girls. We do not fully understand the role of adolescent sex hormones in driving the development of both sexuality and gender identity through the early teen years, so by extension we cannot be sure about the impact of stopping these hormone surges on psychosexual and gender maturation. We therefore have no way of knowing whether, rather than buying time to make a decision, puberty blockers may disrupt that decision-making process. A further concern is that adolescent sex hormone surges may trigger the opening of a critical period for experience-dependent rewiring of neural circuits underlying executive function (i.e. maturation of the part of the brain concerned with planning, decision making and judgement). If this is the case, brain maturation may be temporarily or permanently disrupted by puberty blockers, which could have significant impact on the ability to make complex risk-laden decisions, as well as possible longer-term neuropsychological consequences. To date, there has been very limited research on the short-, medium- or longer-term impact of puberty-blockers on neurocognitive development. In light of these critically important unanswered questions, I would suggest that consideration is given to the rapid establishment of the necessary research infrastructure to prospectively enrol young people being considered for hormone treatment into a formal research programme with adequate follow up into adulthood, with a more immediate focus on the questions regarding puberty blockers. The appropriate research questions and protocols will need to be developed with input from a panel of academics, clinicians, service users and ethicists. Without an established research strategy and infrastructure, the outstanding questions will remain unanswered and the evidence gap will continue to be filled with polarised opinion and conjecture, which does little to help the children and young people, and their families and carers, who need support and information on which to make decisions.”
“14.4 As set out in Chapter 2, the practice of pausing puberty at Tanner Stage 2 was initiated in the Netherlands, and subsequently adopted in the UK and internationally. The idea was based on a theory from Dr Peggy Cohen-Kettenis whose initial clinical experience was in adult care. Her rationale was that pausing puberty early would help young people to ‘pass’ better in adulthood and ‘extend the diagnostic period’ by buying time to think. The use of puberty blockers for this purpose was initially reported in a single case study (Cohen-Kettenis & van Goozen, 1998) and then in the original Dutch cohort (de Vries, 2011b). 14.5 It may appear surprising that the novel use of a drug for this purpose did not require a more rigorous drug trial. This is because of the way drugs are licensed and can be used off-label (see Explanatory box 5). 14.6 GnRH hormones (referred to as puberty blockers in the treatment of young people) are licensed for patients with precocious puberty (that is, young children who enter puberty too early), as well as for the treatment of some cancers in adults and some gynaecological issues in adults. They have undergone extensive testing for use in precocious puberty (a very different indication from use in gender dysphoria) and have met strict safety requirements to be approved for this condition. 14.7 The situation for the use of puberty blockers in gender dysphoria is different. Although some endocrinologists have suggested that it is possible to extrapolate or generalise safety information from the use of puberty blockers in young children with precocious puberty to use in gender dysphoria, there are problems in this argument. In the former case, puberty blockers are blocking hormones that are abnormally high for, say, a 7-year-old, whereas in the latter they are blocking the normal rise in hormones that should be occurring into teenage years, and which is essential for psychosexual and other developmental processes. 14.8 This approach to the use of puberty blockers in gender dysphoria has been an ongoing source of controversy both nationally and internationally. 14.9 The lack of consensus across the clinical community was highlighted by a 2015 study (Vrouenraets et al., 2015), which approached multi-professional treatment teams worldwide to determine their views on use of puberty blockers. They identified seven themes on which there were widely disparate views: • the (non-) availability of an explanatory model for gender dysphoria • the nature of gender dysphoria (normal variation, social construct or [mental] illness) • the role of physiological puberty in developing gender identity • the role of comorbidity • possible physical or psychological effects of refraining from) early medical interventions • child competence and decision-making authority • the role of social context in how gender dysphoria is perceived. 14.10 The professionals who participated in the study were often conflicted because they recognised the distress of young people and felt the urge to treat them, but at the same time, most had doubts because of the lack of information on long-term physical and psychological outcomes. For several participants, a reason to use puberty suppression was the fear of increased suicidality in untreated adolescents with gender dysphoria. 14.11 The authors of the study concluded that as long as debate remains on these seven themes and only limited long-term data are available, there will be no consensus on treatment. Eight years later, the position is unchanged and many of the same considerations apply to the use of masculinising/feminising hormones in young people.”
“Medical pathways 80. The original rationale for use of puberty blockers was that this would buy ‘time to think’ by delaying onset of puberty and also improve the ability to ‘pass’ in later life. Subsequently it was suggested that they may also improve body image and psychological wellbeing. 81. The systematic review undertaken by the University of York found multiple studies demonstrating that puberty blockers exert their intended effect in suppressing puberty, and also that bone density is compromised during puberty suppression. 82. However, no changes in gender dysphoria or body satisfaction were demonstrated. There was insufficient/inconsistent evidence about the effects of puberty suppression on psychological or psychosocial wellbeing, cognitive development, cardio-metabolic risk or fertility. 83. Moreover, given that the vast majority of young people started on puberty blockers proceed from puberty blockers to masculinising/feminising hormones, there is no evidence that puberty blockers buy time to think, and some concern that they may change the trajectory of psychosexual and gender identity development. 84. The Review’s letter to NHS England (July 2023) The date on the letter is July 2022 not July 2023 advised that because puberty blockers only have clearly defined benefits in quite narrow circumstances, and because of the potential risks to neurocognitive development, psychosexual development and longer-term bone health, they should only be offered under a research protocol. This has been taken forward by NHS England and National Institute for Health and Care Research (NIHR). 85. The University of York also carried out a systematic review of outcomes of masculinising/feminising hormones. Overall, the authors concluded that “There is a lack of high-quality research assessing the outcomes of hormone interventions in adolescents with gender dysphoria/incongruence, and few studies that undertake long-term follow-up. No conclusions can be drawn about the effect on gender dysphoria, body satisfaction, psychosocial health, cognitive development, or fertility. Uncertainty remains about the outcomes for height/growth, cardiometabolic and bone health. There is suggestive evidence from mainly pre-post studies that hormone treatment may improve psychological health, although robust research with long-term follow-up is needed”. 86. It has been suggested that hormone treatment reduces the elevated risk of death by suicide in this population, but the evidence found did not support this conclusion. 87. The percentage of people treated with hormones who subsequently detransition remains unknown due to the lack of long-term follow-up studies, although there is suggestion that numbers are increasing. 88. A problem, that has become increasingly apparent as the Review has progressed is that research on psychosocial interventions and longer-term outcomes for those who do not access endocrine pathways is as weak as research on endocrine treatment. This leaves a major gap in our knowledge about how best to support and help the growing population of young people with gender-related distress in the context of complex presentations.”
“The Review understands and shares the concerns about the use of unregulated medications and of providers that are not regulated within the UK. Any clinician who ascertains that a young person is being given drugs from an unregulated source should make the young person and their family aware of the risks of such treatment.”
“41. In this context, policy officials have been working with regulators and other stakeholders since 2021 to better understand the risks, and the opportunities, for addressing specific concerns raised with the Department about online prescribing. In particular, this work had highlighted a key risk in the continued recognition of prescriptions originating from EEA or Swiss registered prescribers. 42. These issues were discussed at the first of what would become a series of meetings on the topic of online and overseas prescribing, on25 May 2022 . These meetings did not focus solely or mainly on the prescribing of puberty blockers but on overseas and online prescriptions generally – an issue of much wider application. They were initiated after a number of concerns relating to online and overseas prescribing came together, including patients getting access to medicines without sufficient clinical oversight and coming to harm as a result. This meeting took place between DHSC officials and representatives of NHS England, the GMC, the GPhC, the British Medical Association (“BMA”) and the RCGP [Exhibit GS1/014], [DB/680-684]. 43. Here it was noted that there was growing concern about online private prescribing, and the dispensing of these prescriptions. The meeting was provided with a document entitled ‘Evidence Table – as at May 2021’ compiled by DHSC, which identified a number of incidents or events that gave rise to these concerns. This included reference to a number of coronial Reports to Prevent Future Deaths which raised concerns about online prescribing mechanisms [Exhibit GS1/015], [DB/685-688]. The references to the ‘Welsh Gender Clinic” on the second page of that document relate to the clinicians who went on to set up what is now known as GenderGP. The GPhC also provided a briefing paper on the regulation of online pharmacy services [Exhibit GS1/016], [DB/689-692]. 44. The meeting heard that there had been: “…a number of UK based companies deliberately attempting to evade the regulatory framework. Regulatory action has resulted in fines, GMC hearings against a provider, and GPhC action. There are concerns that new models are continuing to be operated to evade scrutiny – for example acting as an introducer to, and agent for, properly registered pharmacies that supply medicines.” 45. The note of this meeting records the various concerns and issues that were raised by the attendees from their perspectives. Of particular note are: a. the views of Claire Bryce Smith of the GPhC, who told the meeting that: …the GPhC had inspected 394 online pharmacies since April 2019 which didn’t meet the standards in quite the same way as bricks and mortar pharmacies. 85% of all pharmacies inspected by the regulator meet its standards but this percentage goes down to 71% for online pharmacies, with some failing as many as nine of the GPhC’s standards. GPhC has served 55 legal enforcement notices on these online pharmacies linked to their provision of online pharmacy services. Most pharmacies comply with improvement notices but some pharmacies have actually been shut down. Inspections found that GPhC standards were not being met and their guidance on providing pharmacy services at a distance was not being followed. This meant the dispensing pharmacies did not adequately safeguard vulnerable people who may be trying to obtain medicines which are not clinically appropriate for them. This puts patients at risk of serious harm or death… b. The views of Martin Marshall of the RCGP, who “felt that gender drugs and HRT are the biggest current issues” and that overseas pharmacies and prescribing operations often shut down and reopened the same business in another name making this a difficult area to police. c. The contributions from Cathy Finnegan of the GMC, who expressed that the GMC case examiners were most concerned about prescribing from abroad. She expressed concerns about the limited patient information that was available to online prescribers and the risks that this created, stating: “…some of the online systems being used are complex and professionals working in them don’t understand their full functionality. They don’t see other parts of the pathway, like accessing checks and balances where patients repeatedly ordering/ ordering too early, or the requirement to ask additional questions. These safeguards are absent. Not all of the people involved are seeing all the information. Whether prescribing or supplying, you still need to decide whether it’s appropriate and prescribers can’t make an informed decision. Over subsequent examination of this topic, this question of information sharing has emerged as a key concern for all the regulators. Undertaking prescribing activity without full knowledge of the patient’s medical history is dangerous. 46. The reports from coroners and other reports of poor practice that were discussed at this meeting were a very real concern. However, the challenge was that there is no data to determine the volume of use of EEA prescriptions. In 2023 it was, therefore, suggested that a consultation mechanism could be used to gather evidence before finalising the proposals (See §10 of Ministerial Submission of7 December 2023 [Exhibit GS1/013], [DB/675-679] (see:[DB/677])). 47. In November 2023 the SoSH held a meeting with representatives of NHS England including the National Director for Specialised Services, John Stewart, to discuss children’s gender identity services. The note of this meeting is produced as [Exhibit GS1/17], [DB/693-697]. Discussing the setting up of a new holistic service specification for children’s gender services in the light of the interim report of the Cass Review and Dr Cass’ recommendations of July 2022, Mr Stewart set out the overall objectives which were “dismantling the legacy of the Tavistock and removing any inappropriate influence of campaign groups on clinical practice.”
“9. Concerns about private prescribing of Puberty Suppressing Hormones and Gender Affirming Hormones are shared widely, including by GPs, pharmacists and organisations representing primary care. The NHS National Medical Director for Specialised Services met with you on 23 November to raise his concerns, and to ask for your support in moving forward with potential solutions to close this loophole which also poses a risk to safety. These issues had also been raised on several occasions with DHSC officials and ultimately require Ministerial action, such as legislation to curtail private prescriptions issued from within the EEA. Alternatively, or at the same time, changes could be made to part XVIIIB of the national Drug Tariff with Ministerial approval. It would be helpful to understand your intentions and likely timeframe in this regard, particularly in view of social media posts made in the past 24 hours by on-line providers who are not regulated in the UK and who have stated their intention to continue to issue prescriptions to children in this country contrary to NHS policy and contrary to the Cass Review.”
“The RCGP recognises that some GPs have particular expertise, or an extended role, in the area of transgender care and supports them to act in their patient’s best interests, within the limits of their competence. For the majority of GPs, without this expertise or extended role, the RCGP considers that the role of the GP does not include the following: - Prescribing bridging prescriptions for those on the waiting list for a GIC. - Prescribing puberty blockers for a patient aged under 18, even on a shared care basis, given the concerns about the evidence base in this area as well as the specialist expertise required to monitor dosage and side effects. The Cass review notes that ‘the Review has already advised that because puberty blockers only have clearly defined benefits in quite narrow circumstances, and because of the potential risks to neurocognitive development, psychosexual development and longer-term bone health, they should only be offered under a research protocol. This has been taken forward by NHS England (NHSE) and the National Institute for Health and Care Research (NIHR)’ and that ‘if an individual were to have taken puberty blockers outside the study, their eligibility may be affected’. This precludes GPs from ever prescribing puberty blockers, excepting any GPs working on clinical trials in this area. …..” …..”
“It is not enough for a prescription to be legally valid; that is just one consideration alongside others, including judgement as to whether a prescription is clinically appropriate. In some cases, prescriptions may have been issued by overseas gender clinics and prescribers who are not under the jurisdiction of UK regulators, which creates additional risk. We expect pharmacies to have taken active steps to assure themselves that all prescribers, including those from overseas, comply with relevant UK regulatory and professional guidance. Reasonable precautions should be taken by pharmacies to assure themselves that the prescriber has sufficient specialist expertise to assess and diagnose gender dysphoria, and to recommend prescriptions for the person concerned...”
“It was morally and medically reprehensible that some online providers not registered in the UK have stated their intention to continue to issue prescriptions to children in this country. I am looking closely at what can be done to curtail any loopholes in prescribing practices, including legislative options.”
“PS said that one justification for acting quickly would be that we are trying to clamp down on rogue actors who are deliberately trying to act on loopholes. LP noted that there needed to be something new which justifies action now: SoS said this was the Cass report (with JY adding that NHSE’s acceptance of the report was also new). [JB] also stated that the Royal College of GPs might put out a policy statement next week. SoS also said that there were already individual stories in the media of certain clinicians trying to circumvent the report’s findings. PS summarise (sic) that the report justified the ban, while the risk of rogue actors justifies the immediacy – with SoS noting that the difficulty in reversing these treatments was a key point.”
“GS said that the ‘open caseload’ of those already on these drugs needed to be managed carefully. SoS stated that there would need to be exceptions – e.g. for those using the drugs for precocious puberty or the menopause – and there would also need to be an element of clinical judgement allowed for those already on these drugs where it might not be safe to stop them instantly. PS emphasised that we would need to have a very low tolerance for safety risk, to avoid any harm even if the overall numbers were fairly small. SoS agreed with this.”
“Private practitioners. The prescription of unlicensed or off-label medications is subject to individual professional regulation by the General Medical Council and other relevant professional regulators. Practitioners should usually prescribe licenced medications in accordance with the terms of their licence but on the basis of an assessment of the individual patient the practitioner may conclude for medical reasons that it is necessary to prescribe a medicine to meet the specific needs of a patient. The GMC guidance states that the practitioner must be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy. In addition, the practitioner must take responsibility for prescribing and overseeing the patient's care including monitoring and follow up treatment. ”
“For other CYP who have accessed GnRH analogues for the purposes of puberty suppression for gender dysphoria through NHS or non-NHS prescribing, stopping these medicines can be achieved without significant impact on endocrinology homeostasis but the emotional impact for a group of young individuals known to have a high risk of self-harm and suicide on acute treatment withdrawal must be mitigated. With the recent initiation of the CYP gender services in the North West and London there is capacity only to manage the current transferred workload from the Tavistock GIDS service and no capacity to provide any additional support as a consequence of legislation. In principle those accessing PSH from private providers will need to secure additional psychosocial support from those private providers who initiated treatment. Adequate notice of the change in legislation would be important to give the CYP and their parents time to access appropriate support either within the private sector or securing referrals to local CYP mental health services if significant mental health instability is likely to ensue. In turn we know the current constraints of the CYP mental health services across many parts of the country. Harms that might occur in this young patient cohort may be attributed to a change in legislation whether or not they are directly related to that change.”
“I have also made it my priority to protect our children, who have been questioning their identity in ever increasing numbers. The Cass review laid bare the damaging effect that social media and degrading pornography have had on young people’s sense of self. It also set out clearly the need for extreme caution in medical interventions. Today, I want to set out my clear intention to introduce a banning order on puberty blockers, with limited exceptions, undersection 62 of the Medicines Act 1968 . This is an extraordinary use of that power, but it is the right use of that power because we must protect our children and young people from this risk to their safety. Hansard, HC Deb23 May 2024 , vol. 750 col. 1045. ”
“I also welcome what she said about the justifiably cautious and responsible approach she is taking in relation to puberty blockers in the light of the Cass report.”
“You indicated that you wanted the ban to apply to all UK private prescriptions for puberty blockers for gender incongruence/gender dysphoria in children, with NHS services taking on any children currently fully established on puberty blockers and supporting them to stop taking these medicines. Clinical advice from NHS England (see annex A) is that this is an extremely vulnerable group, liable to self-harm without intensive psycho-social support. The number of children in this group is unknown. There is insufficient capacity within the new specialist NHS services to be able to offer a guaranteed pathway for these additional children at a point when private prescriptions become unlawful. Clinical advice is that it would cause a larger patient safety issue to force them to stop treatment without adequate support in place, than it would to allow them to continue in the short-term. On patient safety grounds and in order to secure continuity of care, we therefore recommend that the banning order continue to allow UK private providers to prescribe to children who are already established on a medical pathway…”
“In previous meetings, the SoS has indicated that in light of the Cass report she did not wish to consult specialist orgs claiming to represent those with GD and their families/carers. Can you confirm that this steer remains?”
“Patients under 18 are strongly advised to meet with their clinician to fully understand the risks of continuing taking GnRH analogues for puberty suppression. If the patient wants to continue an NHS or private prescriber can continue to prescribe following a shared decision-making conversation about the risks with the patient. Prescription must be marked SLS.”
“(1) Subject to the following provisions of this section, the Ministers, where it appears to them to be necessary to do so in the interests of safety, may by order— (a) prohibit the sale or supply, or the importation, of medicinal products of any description, or falling within any class, specified in the order, or (in such manner as may appear to them to be sufficient to identify the products in question) designate particular medicinal products and prohibit the sale or supply, or the importation, of those particular products. (2) A prohibition imposed by order under this section may be a total prohibition or may be imposed subject to such exceptions as may be specified in the order. (3) Before making an order under this section the Ministers, unless in their opinion it is essential to make the order with immediate effect to avoid serious danger to health, shall consult the appropriate committee. (4) Where an order is made under this section without prior consultation with the appropriate committee in accordance with subsection (3) of this section, the prohibition imposed by the order shall not have effect after the end of such period, not exceeding three months from the date on which it comes into operation, as may be specified in the order, but without prejudice to the making of any further order in accordance with the provisions of this section (including this subsection). (5) If any organisation consulted in pursuant of section 129(6) of this Act with respect to a proposal to make an order under this section have given notice to the Ministers of their desire to be heard under this subsection, or have made representations in writing to the Ministers with respect to that proposal, then before making the order – (a) if the organisation have given notice of their desire to be heard, the Ministers shall arrange for them to have an opportunity of appearing before, and being heard by, the appropriate committee, or (b) if they have made representations in writing, the Ministers shall refer those representations to the appropriate committee, and, where the organisation have availed themselves of the opportunity of being heard, or after considering the representations, as the case may be, the appropriate committee shall report their findings and conclusions to the Ministers and the Ministers shall take that report into account in determining whether to make the order. (6) Subsection (5) of this section shall not have effect where in the opinion of the Ministers it is essential to make the order with immediate effect as mentioned in subsection (3) of this section. (7) … (8) In this section, “appropriate committee” means whichever the Ministers consider appropriate of – (a) the Commission; or (b) An expert committee appointed by the Ministers, or by one of them acting alone.”
“Before making any regulations under this Act and before making any order under this Act (except an order made in accordance with any provision of this Act under which, in case of urgency, an order can be made with immediate effect) the Ministers proposing to make the regulations or order shall consult such organisations as appear to them to be representative of interests likely to be substantially affected by the regulations or order.”
“Exception for private prescriptions: patients aged under 18 6(1) Article 3 does not apply to a sale or supply in pursuance of a private prescription, if— (a) Condition A is met; (b) if the private prescription is a prescription, rather than a direction, which is or purports to be in accordance with the requirements of regulation 217, 218, 219 or 219A of the 2012 Regulations (which relate to requirements for paper and electronic prescriptions), Condition B is met; (c) if the private prescription was issued on or after3rd June 2024 , Condition C is met; and (d) unless the sale or supply is to or for a person who, on any occasion, started a course of treatment with a GnRH analogue before3rd June 2024 , Condition D is met. (2) Condition A is that on the day the private prescription was issued, the patient in respect of whom it was issued was aged under 18. (3) Condition B is that— (a) the prescription has included within it the patient's age and is annotated by the prescriber with "SLS"; or (b) if the prescription was issued before3rd June 2024 , the person to whom the GnRH analogue is to be sold or supplied produces to the person selling or supplying the GnRH analogue a specified document, a UK birth certificate or a current national identity document that verifies, to the reasonable satisfaction of the person selling or supplying the GnRH analogue, the age and identity of the person to or for whom the GnRH analogue is to be sold or supplied. (4) Condition C is that the private prescription was issued by an approved UK prescriber. (5) Condition D is that the purpose for which the private prescription was issued is a purpose other than treatment for the purpose of puberty suppression in respect of gender dysphoria, gender incongruence or a combination of both. (6) For the purposes of paragraph (1)(d), a person is treated as having started a course of treatment with a GnRH analogue if, in the six month period before3rd June 2024 , that person was issued with a NHS or private prescription for a GnRH analogue, whether or not the prescription has been dispensed or the prescribed GnRH analogue has been taken by that person before3rd June 2024 . (7) For the purposes of paragraph (5), treatment is treatment for the purpose of puberty suppression in respect of gender dysphoria, gender incongruence or a combination or both if it is, viewed objectively, treatment for that purpose, as gender dysphoria and gender incongruence are ordinarily understood as part of medical practice in Great Britain.”
“"Serious" in ordinary parlance connotes something towards the top end of the scale. Dictionary synonyms of the adjective are consistent with this and include: severe, grave, big, and major”
“67. The EU has a clear interest under the Treaty in national restrictions on the sale and movement of goods. The ECJ accordingly requires member states to limit marketing bans, which are the most drastic form of measure, to cases where “the real risk alleged for public health appears sufficiently established on the basis of the latest scientific data available at the adoption” of the measure in question: Commission v Denmark[2003] ECR I-9693 , §48. In Alpharma v Commission[2002] ECR II-3495 the Court made it clear that high-grade scientific assessment of risks was “an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures”
“152….as the Court of Justice and the Court of First Instance have held, where there is scientific uncertainty as to the existence or extent of risks to human health, the Community institutions may, by reason of the precautionary principle, take protective measures without having to wait until the reality and seriousness of those risks become fully apparent (the BSE judgment .., the NFU judgment … and the judgment at first instance in Bergaderm and Goupil v Commission …. 153. It follows that, as a result of the precautionary principles, as enshrined in Article 130r(2) of the Treaty, the Community institutions were entitled to take a preventive measure regarding the use of bacitracin zinc as an additive in feedingstuffs, even though, owing to existing scientific uncertainty, the reality and the seriousness of the risks to human health associated with that use were not yet fully apparent. 154 A fortiori, the Community institutions were not required, for the purpose of taking preventative action, to wait for the adverse effects of the use of the product as a growth promoter to materialise...” 155. Thus, in a situation in which the precautionary principle is applied, which by definition coincides with a situation where there is scientific uncertainty, a risk assessment cannot be required to provide the Community institutions with conclusive scientific evidence of the reality of the risk and the seriousness of the potential adverse effects were that risk to become a reality (see … Mondiet …and Spain v Council …).”
“Policy Context What is being done and why? 5.1 The Cass Review found that there is not a reliable evidence base upon which to make clinical decisions about the use of GnRH analogues to treat gender dysphoria/incongruence, or for children and their families to make informed choices. The Cass Review concluded that because of the limited evidence, and potential risks to patient safety, these medicines should only be offered for this purpose under a research protocol, and/or with the agreement of the national multi-disciplinary team. The NHS has implemented these recommendations. The Cass Review’s conclusions have been accepted and endorsed by the UK governments, UK regulators and clinical leaders. 5.2 It is the government’s view that the same principles to ensuring the safety of children and young people should be taken regardless of the clinician or setting responsible for their care. The government agrees with the Cass Review conclusions that for this group of children and young people safety can be best assured under the supervision of a national multi-disciplinary team and with new initiations onto a medical pathway for gender dysphoria/incongruence done under the governance of a clinical trial. The government is aware that not all prescribing of these medicines is being done in accordance with this position, and is of the view that this presents a risk to patient safety. The Order is therefore focused on the immediate actions required to prevent harm. 5.3 The Regulations and the Order align with the NHS’s clinical policy, providing clarity and removing ambiguity for all parties – patients and their families, prescribers, employers/ commissioners and regulators. Where a patient is under the care of a UK-regulated prescriber, to ensure patient safety use of these medicines should be consistent regardless of the setting in which the prescriber is operating. The only excepted prescribers from these regulations are in NHS secondary or tertiary care, where the detailed approach to managing patients with gender dysphoria is set out in the interim service specification. 5.4 In the case of prescriptions issued in the EEA and Switzerland, dispensing pharmacists in the UK cannot easily verify the purpose for which a prescription has been written. For this reason all prescriptions of GnRH analogues from an EEA or Switzerland registered prescriber for patients under the age of 18 dated after3rd June 2024 will no longer be dispensed in the UK. Prescriptions of GnRH analogues from an EEA or Switzerland registered prescriber for patients over the age of 18 will be dispensed in the UK providing verification of age can be shown to the dispensing pharmacist. This provision is included because it is not mandatory for prescriptions from EEA prescribers to include the age/date of birth of patients over the age of 12. 5.5 Only legislation can achieve consistent action to ensure patient safety across all sources of prescriptions. The Order is being made on an emergency basis to respond to the serious safety risks for vulnerable children and young people without delay. At present providers registered outside of the UK, beyond the jurisdiction of UK regulators, are able to continue to offer services that are not evidence based and treatment options that are not available through UK registered providers for safety reasons. The emergency order enables these loopholes to be closed immediately. It is necessarily a temporary measure, enabling further work to be done to determine the appropriate legislative approach for the future. 5.6 Breach of the Order is a criminal offence under theMedicines Act 1968 . Communications and guidance will be issued to set out clearly the new requirements to ensure all those affected have relevant information to ensure compliance with the Order. What was the previous policy, how is this different? 5.7 The previous policy was that there were no legal restrictions which solely related to prescribing of GnRH analogues. Prescribers were expected to prescribe these medicines in accordance with the medicine’s marketing authorisation and best available clinical evidence. In the case of gender dysphoria/gender incongruence, these expectations were not met, leading to variation in practice, and risks to patients’ safety. 5.8 GnRH analogues are prescribed off-label (i.e. for purposes for which they are not licensed) to treat gender dysphoria and gender incongruence in children, and there is a lack of reliable evidence for prescribers to use, with variation in prescribing practice. The Order and the Regulations therefore take necessary steps to ensure consistent access to and prescribing of GnRH analogues.”
“Why was this approach taken to change the law?” “6.12 This is the only possible approach to make the necessary changes on an urgent basis. It is necessary in the interests of safety to prohibit the sale and supply of GnRH analogues to patients under the age of 18 in the case of both private and NHS prescriptions, unless certain conditions are met, and the Order taken with the Regulations achieves this aim. 6.13 The approach of amending the 2004 Regulations in order to restrict NHS prescribing was taken, rather than using the Order, because this is a legal approach that is familiar to NHS practitioners. There are structures in place to respond to changes to the 2004 Regulations and to ensure that those changes are communicated to practitioners as quickly as possible, and embedded in digital systems for prescribing and dispensing.”
“The Order and the Regulations will deliver: • Reductions in clinical risk for all children currently using EEA prescriptions to obtain puberty blockers in the UK, and those who would otherwise seek to do so via this route; • Reductions in clinical risk for new patients seeking to use UK private prescribing to obtain puberty blockers for gender dysphoria specifically; • Reductions in clinical risk for new patients seeking to use NHS prescribing to obtain puberty blockers for gender dysphoria specifically; and • Improved consistency of treatment.”
“• A risk to physical or mental health where patients’ treatment is changed or disrupted; • A risk to mental health where patients are unable to get treatment that they were expecting, or which they believed might be beneficial despite limited evidence; • A potential increase in demand for NHS care, if people stop using alternative providers; • A potential risk of confusion and uncertainty given that the Order is temporary, albeit with a more permanent solution likely to follow; and • A potential risk of patients seeking unsafe treatment and/or the creation of “black market” demand. These risks will be mitigated in part by the policy design (e.g. allowing existing patients to continue their treatment) and in part through provision of support through the NHS and the voluntary sector and guidance provided to patients and their families, prescribers and pharmacists.”
“Given the rigorous evidential reviews and research upon which the Cass Review’s final report was based, and particularly in light of the low quality of the existing evidence in this area prior to the Cass Review, the recommendations contained in the final report were considered by the Department to constitute the most appropriate and sufficiently evidence-based clinical guidance upon which to base policy decisions in this area.”
“Some practitioners abandoned normal clinic approaches to holistic assessment, which has meant that this group of young people have been exceptionalised compared to other young people with similarly complex presentations. They deserve very much better.”
“I have also made it my priority to protect our children, who have been questioning their identity in ever increasing numbers. The Cass review laid bare the damaging effect that social media and degrading pornography have had on young people’s sense of self. It also set out clearly the need for extreme caution in medical interventions. Today, I want to set out my clear intention to introduce a banning order on puberty blockers, with limited exceptions, undersection 62 of the Medicines Act 1968 . This is an extraordinary use of that power, but it is the right use of that power because we must protect our children and young people from this risk to their safety. Hansard, HC Deb23 May 2024 , vol. 750 col. 1045. ”
“I also welcome what she said about the justifiably cautious and responsible approach she is taking in relation to puberty blockers in the light of the Cass report.”
“We are endeavouring to mitigate this risk by: ensuring prescribing routes remain open for existing users, planning for wide communications to the health system and patients about the support available to this group of patients, and asking the NHS to signpost to and prepare mental health and crisis support services ….”
“154. Given the emergency nature of the Order and the short timeframe in which these measures were necessarily implemented, the production, development and refinement of guidance and other measures to mitigate any negative impacts of the Legislation will necessarily be an iterative process. It will be informed by continuing monitoring and evaluation of the impacts of the order through continued engagement with the NHS, professional leaders and professional regulators, and monitoring of available prescribing data.”
“108 It is common ground that, whether or not consultation of interested parties and the public is a legal requirement, if it is embarked upon it must be carried out properly. To be proper, consultation must be undertaken at a time when proposals are still at a formative stage; it must include sufficient reasons for particular proposals to allow those consulted to give intelligent consideration and an intelligent response; adequate time must be given for this purpose; and the product of consultation must be conscientiously taken into account when the ultimate decision is taken: R v Brent London Borough Council, Ex p Gunning(1985) 84 LGR 168 .”
“On24 May 2024 , the BMA’s general practitioner committee chair and a member of staff were contacted via email by DHSC civil servants with a request to meet on28 May 2024 for an “urgent discussion” following the [First Defendant] informing the House of Commons of her intention to introduce a “banning order on puberty blockers” the previous day. At this meeting the DHSC civil servants provided details of the process of how the banning order was intended to be introduced and its scope. BMA members of staff raised a small number of questions for clarification. No views were formally sought, or provided, from the BMA. To describe this meeting as a “consultation” is, we believe, wholly inappropriate and misleading. I repeat my request to you to correct the record where this has been stated.”
“82. The Court reiterates that the concept of “private life” is a broad term not susceptible to exhaustive definition. It includes not only a person’s physical and psychological integrity but can sometimes also embrace aspects of an individual’s physical and social identity. Elements such as gender identity or identification, names, sexual orientation and sexual life fall within the personal sphere protected byArticle 8 of the Convention (see, in particular, Van Kück, cited above, § 69 and Schlumpf v. Switzerland, no. 29002/06, § 77,8 January 2009 , and the references cited therein).”
“… although Article 8 contains no explicit procedural requirements, the court will have regard to the decision making process to determine whether it has been conducted in a manner that, in all the circumstances, is fair and affords due respect to the interests protected by Article 8. The process must be such as to secure that the views of those whose rights are in issue are made known and duly taken account of. What has to be determined is whether, having regard to the particular circumstances of the case and notably the serious nature of the decisions to be taken, the person whose rights are in issue has been involved in the decision making process, seen as a whole, to a degree sufficient to provide them with the requisite protection of their interests. If they have not, there will be a failure to respect their family life and privacy and the interference resulting from the decision will not be capable of being regarded as "necessary" within the meaning of Article 8.”
“36. Private and family life are very broad concepts. There is no doubt that Mr Condliff's state of health is having a seriously adverse effect on his private and family life in the most basic ways, which without bariatric surgery will continue and is likely to become worse. However, harsh as this must seem to Mr Condliff, I do not see that the application of the IFR policy involves a lack of respect for Mr Condliff's private and family life. The policy of allocating scarce medical resources on a basis of the comparative assessment of clinical needs is intentionally non-discriminatory. The statutory function of the PCT is to use the limited resources provided to it for the purposes of the provision of healthcare, i.e. services in connection with the prevention, diagnosis and treatment of illness. To perform that function by allocating those resources strictly according to the PCT’s assessment of medical need, i.e. an assessment based on clinical factors, is to do no more than to apply the resources for the purpose for which they are provided without giving preferential treatment to one patient over another on non-medical grounds. … 41. Although the Strasbourg Court has recognised that in principle article 8 may be relied on to impose a positive obligation on a state to take measures to provide support for an individual, including medical support, there is no reported case in which the court has upheld such a claim by an individual complaining of the state's non-provision of medical treatment. Attempts have been made, but they have been unsuccessful. I would adopt the summary given by Lord Brown in R (McDonald) v Royal Borough of Kensington and Chelsea[2011] UKSC 33 . In that case the Supreme Court rejected a claim that the defendant local authority was in breach of article 8 by failing to provide the claimant with the level of care which she felt was necessary for the maintenance of her basic human dignity. 42. Lord Brown said: “15. Article 8 is too well known to require citation again here. There is no dispute that in principle it can impose a positive obligation on a state to take measures to provide support and no dispute either that the provision of home-based community care falls within the scope of the article provided the applicant can establish both (i) “a direct and immediate link between the measures sought by an applicant and the latter's private life” – Botta v Italy(1998) 26 EHRR 241 , paras 34 and 35 – and (ii) “a special link between the situation complained of and the particular needs of [the applicant's] private life”: Sentges v The Netherlands(2003) 7 CCLR 400 , 405. 16. Even assuming that these links do exist, however, the clear and consistent jurisprudence of the Strasbourg Court establishes “the wide margin of appreciation enjoyed by states” in striking “the fair balance … between the competing interests of the individual and of the community as a whole” and “in determining the steps to be taken to ensure compliance with the Convention”, and indeed that “this margin of appreciation is even wider when … the issues involve an assessment of the priorities in the context of the allocation of limited state resources” – Sentges, at p 405, Pentiacova v Moldova (Application No 14462/03 (unreported)4 January 2005 , p 13) and Molka v Poland (Application No 56550/00 (unreported)11 April 2006 , p 17). Really one only has to consider the basic facts of those three cases to recognise the hopelessness of the article 8 argument in the present case. Sentges (considered by Rix LJ at para 64 of his judgment) concerned a sufferer from muscular dystrophy complaining of a refusal to supply him with a robotic arm. Without it he depended on others for every single act and so was unable to develop and establish relationships with others; with it, his “severely curtailed level of self determination would be increased”: 7 CCLR 400, 404. The applicants in Pentiacova suffered from renal failure and complained of insufficient funding for their haemodialysis treatment. The applicant in Molka was confined to a wheelchair and, for want of positive assistance, was unable to vote in local elections. The complaints in all three cases were unanimously held to be manifestly ill-founded and thus inadmissible.”” “15. Article 8 is too well known to require citation again here. There is no dispute that in principle it can impose a positive obligation on a state to take measures to provide support and no dispute either that the provision of home-based community care falls within the scope of the article provided the applicant can establish both (i) “a direct and immediate link between the measures sought by an applicant and the latter's private life” – Botta v Italy(1998) 26 EHRR 241 , paras 34 and 35 – and (ii) “a special link between the situation complained of and the particular needs of [the applicant's] private life”: Sentges v The Netherlands(2003) 7 CCLR 400 , 405. 16. Even assuming that these links do exist, however, the clear and consistent jurisprudence of the Strasbourg Court establishes “the wide margin of appreciation enjoyed by states” in striking “the fair balance … between the competing interests of the individual and of the community as a whole” and “in determining the steps to be taken to ensure compliance with the Convention”, and indeed that “this margin of appreciation is even wider when … the issues involve an assessment of the priorities in the context of the allocation of limited state resources” – Sentges, at p 405, Pentiacova v Moldova (Application No 14462/03 (unreported)4 January 2005 , p 13) and Molka v Poland (Application No 56550/00 (unreported)11 April 2006 , p 17). Really one only has to consider the basic facts of those three cases to recognise the hopelessness of the article 8 argument in the present case. Sentges (considered by Rix LJ at para 64 of his judgment) concerned a sufferer from muscular dystrophy complaining of a refusal to supply him with a robotic arm. Without it he depended on others for every single act and so was unable to develop and establish relationships with others; with it, his “severely curtailed level of self determination would be increased”: 7 CCLR 400, 404. The applicants in Pentiacova suffered from renal failure and complained of insufficient funding for their haemodialysis treatment. The applicant in Molka was confined to a wheelchair and, for want of positive assistance, was unable to vote in local elections. The complaints in all three cases were unanimously held to be manifestly ill-founded and thus inadmissible.””
“58….. as a matter of principle, I consider that where Parliament has conferred a rule-making power on a Minister of the Crown, without including an express duty to consult, but subject to a Parliamentary control mechanism such as the negative resolution procedure, it is not generally for the courts to superimpose additional procedural safeguards.”
‘Nothing in that process fell to be treated as amounting to “consultation”.’ On that basis, the Department accepts that it would have been preferable not use the word “consultation”, rather than simply to state that this was a process of informal engagement. Subject to confirmation by new Ministers, a revised EM will be published in due course alongside SI 2024/727 and 728. In the meantime, we are of course happy for you to refer publicly to this clarification, if you are minded to.”