Puberty Blockers and Consent to Treatment: an Analysis of the High Court’s Ruling

The experimental nature and potential lifelong consequences of puberty-suppressing medication led judges to conclude that the courts must sanction its use for children suffering gender dysphoria, says Michelle Janas

Dr Michelle Janas (PhD), trained as an immunologist and worked in the field of research and experimental medicine for 20 years. She recently embarked on a career change into social work. @Michelle_L_1974

This article was first published in Community Care.

On 1 December, a landmark judgement was delivered in the case of Bell & Anor v The Tavistock And Portman NHS Foundation Trust [2020] EWHC 3274. The High Court was asked to determine whether children experiencing gender dysphoria could give informed consent to receive puberty-suppressing drugs, by achieving Gillick competence.

The court found that competence to consent to such treatment is “highly unlikely” for 13-year-olds and “very doubtful” for those aged 14 or 15. While consent can be presumed for young people aged 16 and 17, medical professionals may want to seek court approval before treatment if there are doubts as to whether it would be in the young person’s long-term best interests.

The judgment will be implemented on 22 December. If the Tavistock or the two NHS trusts who administer the treatment appeal by then, and this is granted by the Court of Appeal, implementation will be deferred until the appeal is decided.

Referrals ceased for under-16s

However, on the day of the judgment, NHS England, which commissions the Tavistock’s Gender Identity Development Service (GIDS), ordered it to cease referring patients under 16 to paediatric endocrinology clinics for puberty blockers unless a ‘best interests’ order for the child in favour of the treatment has been made.

It also ordered GIDS to review all current patients under 16 it had referred for puberty blockers, with lead clinicians either making a best interests application to the courts to determine what should happen or safely withdrawing treatment.

Although NHS England has commissioned a full review of services for children and young people experiencing issues with their gender identity, for the foreseeable future such medical treatment via the GIDS clinic will not be an option for children under 16 without a court order.

This is an important judgment for social work. GIDS provides social work support and also liaises with social workers already working with the children referred to it, while many practitioners work with children with gender identity issues.

‘An experimental treatment with potentially lifelong consequences’

There were two factors that combined to play key roles in this decision: that the treatment is experimental in nature and, because of this, there are unknown and potentially profound lifelong consequences that a child will struggle to comprehend for their adult self.

In this article I will refer directly to the judgment throughout and attempt to outline why the treatment was determined to be experimental, and how the experimental classification impacted on the ruling of competence. I draw upon my 20 years of experience in working in research medicine and early-stage clinical trials, as well as my interest in the ethics of social science research, which I have written about previously.

Puberty blockers (PBs) are formally known as gonadotropin-releasing hormone agonists (GnRHas). This is important as this medication was originally developed for a different use to how it was being prescribed at GIDS. These drugs act by suppressing the release of the sex hormones and are typically used to treat prostate cancer and breast cancer, and to assist in fertility treatments in women.  Controversially, GnRHas are sometimes used to chemically castrate male sex offenders in other countries.

In children, these drugs are used to treat a very rare condition called precocious puberty, in which puberty occurs early at around the age of six. GnRHas halt this premature puberty until the child has reached the appropriate developmental age of around 12 – hence the name ‘puberty blockers’. This is also where the popular notion that these drugs are ‘fully-reversible’ comes from.

The diagnosis of gender dysphoria in itself is somewhat contested, but one which the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) defines as a “difference between one’s experienced gender and assigned gender, and significant distress or problems functioning”. 

GnRHas were being prescribed by GIDS as an ‘off-label’ treatment – meaning the medication is not being used for its licensed purpose – to treat gender dysphoria in adolescent children after the commencement of normally timed puberty. Off-label use of medication is relatively common, particularly for paediatric populations. The caveat, however, is that there should be justifiable scientific evidence that the treatment is safe and beneficial for the patient. The safety data here is paramount, as it helps prevent catastrophic unintended consequences of untested medications, as seen in the thalidomide scandal of the 1950s.

A lack of evidence

The court found that for PBs, the evidence for safety and efficacy was lacking. Indeed, the judges found the absence of data on the age distribution of patients (until 2019-20), the proportion of children referred to it for the treatment with an ASD diagnosis and the percentage who move on to take cross-sex hormones “surprising”.

Also, an interim report from a GIDS Early Intervention Study (which commenced in 2011) concluded that for 44 young people who received pubertal suppression, “there was no overall improvement in mood or psychological wellbeing using standardized psychological measures” (para 73).

The judges also noted an incongruence between the GIDS claim that puberty blockers were “fully reversible” and other evidence, including the NHS website’s section on the treatment of gender dysphoria, which states, “little is known about the long-term side effects of hormone or puberty blockers in children with gender dysphoria” (para 67).

Therefore, due to the lack of both safety and efficacy data on the use on GnHRas for gender dysphoria, the court has considered the treatment to be experimental in nature.

For experimental medicines to become licensed, they need to progress through a strictly defined series of clinical trials, starting from small-scale safety studies and then increasing in size and complexity as the efficacy of the treatment is tested. The design of the studies is agreed in advance, including all the data to be collected, and the patients are carefully monitored. It is an issue which is currently writ large in the public imagination, as we watch the Covid vaccine make its way through these hurdles. To date, GIDS has been unable to produce data from the types of clinical trials that would set puberty blockers along the road to licensing for gender dysphoria. But it has also not produced sufficient scientific evidence to justify their use as off-label medication.

Gillick competence

The court stated explicitly that it was not addressing whether the use of PBs for gender dysphoria was effective, but whether a child could consent to such experimental treatment. Two key issues were defined by the court: whether Gillick competence could be achieved and whether the information being given was adequate (to enable Gillick competence).

Gillick competence is the legal test, in which a minor can consent to surgical, medical or dental treatment in the absence of a parent or guardian. The child needs to show “sufficient maturity to understand what is involved “ (Lord Scarman, 1986). Whilst case law has made clear that the child does not need to comprehend “all the peripheral detail”, they do need to be “able to demonstrate sufficient understanding of the salient facts” (Cobb J, 2019).

It is important to note that the demonstration of Gillick competence is crucial for these children, as GIDS guidelines state that although the parents or guardian must also be in agreement, they cannot give consent on behalf of the child.

The judges considered both evidence presented and case law, and as it is not within my expertise to cover them all, (Marina Wheeler QC gives a neat summary). I will instead restrict myself to medical aspects. One of the pertinent pieces of medical information given in evidence was that practically all children (although, as stated above, GIDS could not give exact data) who started on puberty blockers progress to cross-sex hormone (CSH) treatment (testosterone for females and estrogen for males). Therefore, it was considered relevant by the court that a child was able to understand both the consequences of PBs and CSHs for Gillick competence.

The issues of “lifelong” and “life-changing” implications were raised throughout the judgment. These included the possibilities presented in evidence by GIDS regarding “uncertainty of apparent long-term physical consequences of puberty-blocking on bone density, fertility, brain development and surgical options” (para 62).

Understanding future impact

The judgment cites several pieces of evidence regarding the court’s concerns on a child’s ability to understand the impact on future fertility and sexual relationships. This includes the GIDS testimony that for children these implications will always involve “some act of imagination” (para 122) and a witness statement from a 13-year-old trans boy who wrote, “I haven’t really thought about parenthood…I just have no idea what me in the future is going to think”. Also, Kiera Bell, who brought the legal challenge, stated in evidence, “It is only until recently that I have started to think about having children and if that is ever a possibility.”

In determining competence, the judgment states that a child must not only have sufficient understanding of the factors relevant to the present, but also be able to objectively weigh information relevant to the future (para 124). Thus, although a child might understand the concept of fertility loss, it is not the same as understanding how this might affect their adult life (para 139).

Induced sterility is a principal ethical dilemma in paediatric cancer medicine, as the treatments given for advanced or complex tumours can render a child infertile. However, as the treatment is usually a final life-saving option, sterility, although distressing, is perhaps considered acceptable. The court also refers to this to emphasise the gravity of these types of decisions by stating that “apart from life-saving treatment, there will be no more profound medical decisions for children than whether to start on this treatment pathway” (para 149), a statement which gives context to the court’s justification for the high bar it has set. 

Therefore, although the court acknowledges that a lack of evidence in experimental medicine is not a barrier to competence per se, it is the combination of this with the potentially profound lifelong consequences that a child will struggle to comprehend that has led it to conclude that Gillick competence for a child under 16 is highly unlikely to be reached, no matter how much information and support is given.

This judgment also gives social work pause for thought. Social workers, by virtue of the profession, are interested in issues of social justice and welcome diversity and difference. However, just as for the medical profession, we do need to ensure that foremost, we do no harm.