A clinical ethics approach to the use of puberty blockers in gender incongruence

Gender dysphoria is the name given by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) to the clinically significant distress that can be caused when an individual’s gender identity fails to match the sex assigned to them at birth.¹ The World Health Organization’s International Classification of Diseases, Eleventh Revision (ICD-11) uses the term gender incongruence and places the term in their chapter on conditions related to sexual health to reflect current knowledge that gender-diverse identities are not psychiatric conditions and that classifying them as such can cause stigma and harm.² This definition also reflects that gender incongruence may occur with or without gender dysphoria.

Reversible pubertal suppression (puberty blocking) can be used in transgender (trans) and gender-diverse young people to temporarily stop the production of sex hormones.³ The drugs used are usually gonadotropin-releasing hormone analogues (GnRHa). GnRHa have also been used in paediatrics in the treatment of precocious puberty and other conditions such as catamenial epilepsy and short stature since the 1980s.⁴ These medications delay puberty and the development of secondary sexual characteristics and can help treat gender incongruence or gender dysphoria until gender-affirming hormone therapy can be started.

GnRHa are also useful for young people who experience gender incongruence but are unsure whether they later want to take gender-affirming hormone therapy.⁵ By pausing the physical effects of puberty, they may allow young people time to mature without the distress associated with pubertal changes, before making decisions about whether hormone therapy is right for them. GnRHa should only be started once puberty has commenced (Tanner Stage 2 or later) and only as part of care provided by an interdisciplinary team working together with the young person and their whānau.

There has been a rise in referrals for gender incongruence and gender dysphoria, and demographic data show a significant increase in gender-diverse identities particularly in younger age cohorts.^6,7 The increase has resulted in an increased number of prescriptions for puberty blockers which has—in some areas—resulted in criticism.^8,9 High-profile cases of detransition in those who have taken cross hormone treatment (i.e., not puberty blockers) or undergone surgery have gained international media attention, and decisions to ban gender-affirming care by the United States of America (USA) government continues to generate widespread concern among gender minorities and their advocates.¹⁰

Aotearoa New Zealand has not been immune to the debate, with the National-led Coalition Government recently banning new prescriptions of GnRHa for people with gender incongruence or gender dysphoria. This resulted in the filing of an urgent injunction by the Professional Association for Transgender Health Aotearoa (PATHA) which convinced the high court to provide interim relief by declaring that the Crown should not take any steps to enforce the ban pending judicial review.¹¹

This paper provides a clinical ethics approach to the prescribing of GnRHa. It describes the key ethical principles that should be applied to clinical decision-making and argues for a patient-centred approach that incorporates available evidence, respects patient rights and utilises a multidisciplinary team. It strongly supports the need for ongoing research but highlights that this is a challenge not isolated to gender incongruence or dysphoria but one that must be negotiated for other low-prevalence conditions.

Beneficence and non-maleficence—should treatment be recommended?

In recommending for or against a treatment, physicians need to weigh the risks and benefits of a proposed medication or management plan. This determination is not unique to puberty blockers or gender affirming care but central to all medical and surgical practice. Clinicians routinely assess the potential for harm (non-maleficence) with potential for benefit (beneficence) to determine whether a treatment should be recommended for any individual case. This common approach is aligned with the ethical decision-making framework of Principlism.¹²

In terms of beneficence, puberty suppression delays the onset of secondary sex characteristics in patients where such development causes or contributes to gender dysphoria. In the short or intermediate term, dysphoria can range from discomfort to significant anxiety, depression and—in severe cases—self-harm and suicidality. A study comparing young people who had been on puberty blockers with those who had not at the time of assessment for gender-affirming hormone therapy found that those who had been on puberty blockers had lower rates of anxiety, depression and suicidality, than those who had been through a puberty which did not align with their experienced gender.¹³ This is consistent with a large survey of 20,619 adults which found that those who received pubertal suppression had lower odds of lifetime suicidal ideation than those who wanted pubertal suppression but did not receive it.¹⁴

In the long term—for trans people—secondary sexual characteristics once established can pose further risks beyond dysphoria. Established secondary sex characteristics, e.g., breasts in trans men, or laryngeal prominence “Adam’s apple” with voice deepening in trans women can make it challenging for trans people to “pass” as the gender they identify with (i.e., to be perceived as their gender by others). Trans people are at disproportionately high risk of physical and sexual violence, and hence failure to pass makes it easier to target the trans community for discrimination, harassment and violence.¹⁵

In the USA, homicides against this community have been characterised as a health crisis.¹⁶ In Aotearoa New Zealand, the 2022 Counting Ourselves survey of 2,631 trans and non-binary people found that 44% of participants had experienced discrimination (more than double that of the general population) and 19% received threats of physical violence because they were trans.¹⁷ Trans adults that have been unable to access pubertal suppression are more likely to desire gender-affirming surgery for secondary sex characteristics, with associated risks and costs to the individual and/or health system (access is highly variable internationally). This is because without puberty blockade the development of secondary sexual characteristics becomes more evident and permanent. This can contribute to greater gender dysphoria and—once established—these characteristics require a surgical solution. For example, breast development in trans men can lead to “binding” of breast tissue with subsequent seeking of bilateral mastectomy.

As noted, clinicians are also required to consider potential harm in line with the principle of non-maleficence. Potential risks of GnHRa are discussed as part of the consent process and include potential impact on bone density and final height. If puberty blockers are started prior to growth plate closure, final adult height may be taller than predicted. A prolonged period of puberty suppression may impact bone density for the time they are on a puberty blocker, but this does not typically increase fracture risk and usually improves once sex hormones increase (either after stopping the puberty blocker or starting gender-affirming hormone therapy).^3,4,18–21 It should be noted that these are the same risks inherent to the prescribing of these medications to cisgender children suffering from other conditions that benefit from puberty suppression, such as catamenial epilepsy and short stature.³ GnRH agonists have also been used for polycystic ovarian syndrome (when severe) in adolescence and also in the treatment of prostate cancer and endometriosis in adults.

Although, it could be argued that there is potential psychosocial harm for delaying progression through puberty alongside one’s peers, the authors are not aware of substantive evidence for this. GnRHa are reversible and hence if a young person changes their mind or wishes to come off them to progress through puberty of the sex assigned at birth then this can proceed simply by stopping the medication. Assessment of efficacy of treatment is a routine part of medical practice and if treatment is causing harm or is not efficacious then it should be stopped.

Assessing gender incongruence in young people and weighing benefit and harm in consideration of prescription of medication requires time and sometimes multiple appointments. Gender minorities have higher rates of mental health comorbidities and neurodiversity which may complicate assessment and management.^22,23 However avoiding treatment in this setting should not be seen as avoiding harm as there is no clinical reason or evidence to suggest that gender minorities with comorbidities and/or neurodiverse traits will not experience the same benefits from treatment as their neurotypical peers.

In addition, being neurodivergent does not routinely impact on capacity to provide informed consent, although accommodations may need to be made for different communication and learning styles.²⁴ Failure to treat gender incongruence or dysphoria in this context would therefore be discriminatory and inequitable—denying care on the grounds of complexity and comorbidity rather than an inability to benefit. We emphasise that puberty suppression should be offered only when indicated, in conjunction with comprehensive and ongoing assessment and after detailed discussions with the young person and their parents or guardians. This is provided as part of a multidisciplinary team. In smaller areas of Aotearoa New Zealand this may be more challenging, but any prescription of puberty blockers occurs in a team setting with multiple disciplines including a psychologist. Peer support and advice is also facilitated via the national peer group.

Capacity and consent—can a young person consent to treatment?

All patients have the right to make an informed choice and provide informed consent to any treatment plan as per Right 7 in the Code of Health and Disability Services Consumers’ Rights (the Code).²⁵ The Code also establishes the duty of providers to give the information necessary. Rigorous processes for informed consent allow people to exercise their autonomy—often defined as self-determination.¹²

Informed consent and the exercise of autonomy become more complicated when dealing with a child or young person. However, it is important ethically for clinicians and policymakers to be aware that children have rights and that capacity for decision-making is not as simple as drawing a line under a predetermined age limit. This becomes more important in the situation where a young person and their parents disagree on a management plan or treatment.

A normative—or common—view is that adulthood is reached at the age of 18 when a young person becomes eligible to vote in most countries.²⁶ This is also the view of the United Nations (UN) Convention on the Rights of the Child, which defines a child as anyone under the age of 18.²⁷ However, informed consent laws and policies often stipulate that people younger than 18 can consent. In Aotearoa New Zealand, the Care of Children Act 2004 states that a child of 16 years or older can consent to any medical or surgical treatment as if they were of “full age”.²⁸ Importantly, clinical ethics frameworks and informed-consent policies also emphasise that children younger than 16 can give valid consent provided they demonstrate adequate understanding. For example, Health New Zealand – Te Whatu Ora Capital, Coast and Hutt Valley’s consent policy states that competence is not directly linked to age and that a child under the age of 16 may be able to validly consent to a treatment or procedure depending on the maturity of the child in question and their ability to understand the particular circumstances of the treatment options.²⁹

This emphasis on the capacity to understand, rather than a rigid age limit, is aligned with the principles of Gillick competence—a well-known and widely used concept within paediatrics for young people, including those under the age of 16. Gillick competence derives its name from a 1986 United Kingdom (UK) legal case where a mother objected to the provision of contraceptive advice to her daughters under the age of 16 without parental consent.³⁰ The House of Lords in the case determined that the child had sufficient maturity and intelligence to understand the treatment and implications and hence had the ability to consent. Hence, a child is deemed to be competent to make their own decisions not when meeting a set age but when demonstrating the maturity and understanding required to make a decision.

These principles of Gillick competence are the same as that expressed in the Court of Appeal’s decision in Bell v Tavistock—one of the most well-known legal cases examining the use of puberty blockers in young people. The Court noted the complexity of the decision-making required but emphasised that the ability to consent was a determination of doctors and their teams, not the Courts.³¹ In terms of gender-affirming care, the UN Convention on the Rights of the Child—to which New Zealand is a signatory—also protects the rights of the child to preserve their identity. It states that the views of the child must be given due weight even in circumstances where they cannot provide meaningful consent.²⁷

We note concerns regarding the higher rates of neurodiversity, such as autism spectrum disorder (ASD), in those presenting with gender dysphoria.²³ Although there may be cases whereby ASD or other forms of neurodiversity are severe enough to compromise consent, to determine that all cases of ASD invalidate consent would be discriminatory (Right 2, the Code) and hence unethical.²⁵ The appropriate approach should be the same as other cases of gender incongruence or dysphoria and that is to undertake individual capacity testing. This occurs commonly within other areas of medical practice. Capacity testing frequently occurs in the context of comorbidity, co-existing mental illness or intellectual disability without the presumption that capacity has been lost.

So how does this information apply to the prescription of puberty blockers in young people? In practice, decision-making for all gender-affirming care for those under 18 is usually made collaboratively with the patient and multidisciplinary team as well as the whānau.²⁴ For those lacking Gillick competence, parental or guardian consent is required alongside the child’s assent—a process that affirms patient participation in informed-consent processes commensurate with their age.³²

Hence, clinicians should assess the capacity of the child or young person to understand their condition and the potential consequences (positive and negative) of a decision to treat. Capacity for decision-making rests on these abilities, not a set age. Although it is always hoped that decision-making can be collective between parent and child, it is important, ethically, to note that parents do not retain sole decision-making capacity over healthcare just because a child is under the age of 16; the authority for parents to make decisions for their children is not absolute and diminishes with evolving development. It should also be highlighted that the process of consent is ongoing and not one isolated to the initiation of puberty blockers. Desire for—and therefore consent for—ongoing treatment is part of routine follow-up. Importantly, any decision to consider sex hormone treatment at a later date constitutes a change in treatment and hence requires a separate and additional consent process to that undertaken for puberty blockers.

Is a ban on puberty blockers ethical?

The increasing use of puberty blockers as well as high profile cases of desistance or detransition have led to calls for bans on the use of this medication.^8,9,30 (Desistance is often poorly defined but can be generally regarded as describing a process whereby individuals may cease social or medical transition or re-identify with a previous gender identity). Advocates of a ban highlight a lack of research into the long-term impacts of these agents. However, a ban would compromise the principles of beneficence and non-maleficence for trans people, is inconsistent with its long-term use in other disorders and sets gender incongruence or dysphoria apart from other rare conditions in terms of evidence requirements.

The majority of studies on trans health involve adults, and there are legitimate concerns about a comparative paucity of evidence in the paediatric population.^33,41 The data on adults also often use hormonal treatment without a separate or singular focus on reversible pubertal suppression. However, the literature on adults demonstrates a benefit to gender-affirming care,^{33–35,39–41} and the evidence that is available for trans youth is consistent with that.^{4,13,14,17,36,38}

To ban puberty suppression for all patients when the available evidence consistently shows benefit and reduced harm violates the fundamental ethical principles of beneficence and non-maleficence. Of note, the highly publicised and criticised UK Cass Review (that critiqued UK gender-identity services) still recognised that some youth benefited from gender-affirming treatment and transition.^42,43 The medications have also been used safely for treatment in other disorders for many decades and are reversible, so to argue that the medication is unsafe is inaccurate.^3,4

Groups who support and advocate for banning pubertal suppression medication for gender incongruence and dysphoria often cite concerns about the few patients who perhaps initially have a trans identity but later return to a cisgender identity. But even here the argument seems flawed, as puberty suppression is reversible and does not predetermine a decision to proceed to further hormonal or surgical treatment. Gender-affirming hormone therapy has irreversible effects and one of the benefits of puberty blockers is that they allow people time to consider decisions about these other treatments without leading to bodily changes. Clinicians working in this area also support young people who choose to stop puberty-suppressing medication and allow puberty to resume. It should also be noted that detransition is not necessarily associated with regret and that those who choose to detransition do not always do so in order to adopt a cisgender identity.⁴⁴

Although the paucity of research is often cited as a reason for a ban, this is not something isolated to gender dysphoria. Those identifying as trans are still low in number at around 0.7% of the Aotearoa New Zealand population, and not all will desire medical treatment for gender dysphoria.^7,17 Data from the UK show that gender dysphoria is still uncommon, even in younger cohorts, e.g., only one in 200 17–18-year-olds report gender dysphoria and not all will desire pharmacological treatment.⁴⁵ Small, heterogenous populations—such as the gender-diverse community—can make randomised controlled trials (RCTs) difficult and statistical power challenging to accomplish.⁴⁶ For puberty blockers, RCTs are also not possible due to the inability to blind to the onset of puberty. Non-blinded trials would raise serious ethical issues as those in a placebo arm would proceed through puberty and suffer the gender dysphoria and mental health consequences associated with that.

For gender-affirming care, some have argued that well-designed observational studies should be of sufficient quality to guide care and policy.⁴⁷ These challenges are also common in paediatric medicine and other less common conditions. Although some areas of paediatrics are informed by RCTs, some are not, and care should be taken to not demand a higher standard of research for gender-affirming care over other conditions.⁴² To do so—especially when puberty suppression is reversible—would compromise the principle of justice, which requires clinicians and health providers to treat people equally and fairly and avoid discrimination.¹²

This is not an argument against further research nor repudiation of concerns about a lack of high-quality longitudinal studies, but it highlights some of the difficulties that clinicians face in working with uncommon conditions and where there are barriers to RCTs. Pragmatic approaches are often required, and gender incongruence or dysphoria should not be subjected to greater requirements for clinical research than other low-prevalence conditions. Research should be ongoing and the authors strongly believe these should be longitudinal in nature with regular reporting throughout adolescence and early adulthood. However, there is clear evidence for puberty suppression clinically in children and youth with gender incongruence with dysphoria, and to deny them treatment with blanket bans would be unethical.

Summary and recommendations

Puberty suppression, i.e., GnRHa, can be used to benefit patients and reduce harm in young people with gender incongruence. Puberty blockers can decrease gender dysphoria, anxiety, depression and suicidality and increase overall wellbeing. Individual, patient-centred assessments should be performed by multidisciplinary teams experienced in providing gender-affirming care to determine whether puberty suppression should be recommended. Capacity for decision-making should not be based on a set age limit but on the ability to understand treatment risks and benefits. The rights of the child should be respected regardless of capacity for decision-making. This includes active participation in discussion and decision-making processes commensurate with abilities. Blanket bans on puberty blockers risk significant harm to a vulnerable patient population, with considerable potential to benefit from treatment, and should be avoided on ethical grounds. Research should be ongoing but in line with justice and fairness, and evidence demands should not be higher than for other paediatric or low-prevalence conditions.