Puberty blocking drugs for gender dysphoria: High Court hands down critical ruling

Articles | Tue 8th Dec, 2020

1. Last week judgment was handed down in the case of Tavistock v Bell [2020] EWHC 3274 (Admin), a landmark judicial review of medical treatment for gender dysphoria in minors. In a nutshell, the Divisional Court, comprising Dame Victoria Sharp, Lord Justice Lewis and Mrs Justice Lieven, concluded that puberty blocking drugs were an innovative and experimental treatment, and one which children under the age of 16 were unlikely to be able to consent to (very unlikely in the case of under-14s); clinicians giving the treatment to 16- and 17-year olds were advised to apply to the Court if they had any doubt whether it was in their patient’s best interests.

2. The judgment has generated significant media attention. Its subject, the appropriateness of medical interventions to treat gender dysphoria in young people, has been the focus of an increasingly polarised public debate in recent years.  Many people feel strongly about it.  My aim in this article is to look at the implications of the Divisional Court’s judgment for medical law.

The parties

3. The Defendant, the Tavistock and Portman NHS Foundation Trust (“D”), runs the Gender Identity Development Service (“GIDS”). GIDS may refer young people to one of two NHS Trusts, the First and Second Interveners, (University College London Hospitals NHS Foundation Trust and Leeds Teaching Hospitals NHS Trust, the “Trusts”) for consultation and/or assessment with a view to being prescribed puberty blocking drugs (“PBs”).

4. The First Claimant, Ms Bell, was a natal girl who was referred to GIDS at the age of 15. According to her evidence, she had displayed gender non-conformity at a young age, during a traumatic childhood, and at secondary school she felt disgusted by her body and began to question her gender identity.  At the age of 14 she began to do internet research about gender identity disorder and became convinced that transitioning to a male body was the answer.  Aged 16 she commenced PBs, aged 17 she commenced testosterone, and aged 20 she underwent a double mastectomy.  During the course of this treatment she experienced doubts, but these doubts were allayed by inter alia speaking to a male friend and browsing online forums.

5. Following the conclusion of her treatment Ms Bell felt deeply unhappy with her new identity; she now (aged 23) regrets the treatment and wishes to identify as a woman. She said in her witness statement, “I cannot reverse any of the physical, mental or legal changes that I went through.  Transition was a very temporary, superficial fix for a very complex identity issue.”

6. The Second Claimant, Mrs A, is the mother of a 15-year-old girl who has Autistic Spectrum Disorder (ASD) and is worried that her daughter might be referred to GIDS and prescribed PBs. The Third Intervener, Transgender Trend Limited, is an organisation which provides resources regarding gender dysphoria and has concerns about the impact of PBs.

The judicial review application

7. D and the Trusts recognise three stages of medical intervention for treatment of gender dysphoria[1]. The first stage is the administration of gonadotropin-releasing hormone agonists (GnRHa), a form of puberty blocking drug, to suppress the physical developments of puberty.  In the year 2019/20 those referred for this treatment were aged between 10 and 18.  The second stage is the administration of cross-sex hormones (CSH), which is intended to induce something like the process of puberty that would occur for those of the opposite sex.  The third stage is gender reassignment surgery.  The second and third stages may only be embarked upon from the ages of 16 and 18 respectively.

8. The Claimants sought a declaration that (a) children under the age of 18 were not capable of consenting to the administration of PBs and (b) in any event, the information provided by D was misleading and inadequate for informed consent.

9. D’s practice at GIDS was to require both the parents’ and the child’s informed consent as a precondition for referral to the Trusts for treatment with PBs. The question as to whether parental consent alone would be sufficient was therefore not addressed in the proceedings.

10. The Court heard evidence from doctors employed by D and the Trusts and from a range of individuals concerned about the treatment.

11. The purpose of PBs – as advanced by D – was to give the young person time to think about their gender identity before deciding whether to progress further with (irreversible) gender reassignment treatment. This description of the treatment’s purpose had been the subject of criticism in a 2019 report by the Health Research Authority, which commented that, “It would have reduced confusion if the purpose of the treatment had been described as being offered specifically to children demonstrating a strong and persistent gender identity dysphoria at an early stage in puberty, such that the suppression of puberty would allow subsequent cross-sex hormone treatment without the need to surgically reverse or otherwise mask the unwanted physical effects of puberty in the birth gender.”  The Court echoed those concerns, noting a lack of clarity as to the treatment’s clinical purpose.

12. The Claimants submitted (on the basis of medical evidence which they adduced) that the prescription of PBs in fact supported the persistence of gender dysphoria, when the condition might otherwise have resolved itself during adolescence. They argued further that, even if the treatment’s physical consequences were mostly reversible, it prevented a young person from enjoying a period of normal biological, psychological and social experience during adolescence, which could never be recovered.

13. The relationship between the first and second stages of treatment (PBs and CSH) was also disputed. The second stage, CSH, had irreversible consequences, for example on an individual’s fertility.  D insisted that the two stages were truly separate and that a young person commencing PBs needed only to consent to that particular treatment.  To the Court’s surprise D was unable to provide data showing the percentage of young people referred by GIDS for PBs who went on to be prescribed CSH.  It was concluded (drawing from evidence arising from similar treatment in the Netherlands) that the vast majority of young people who commence PBs progress to treatment with CSH.

14. The following evidence came out during the proceedings:
15. 1. At the conclusion of a period of assessment at GIDS, a young person, if they met certain criteria, would be referred to the Trusts with a view to treatment with PBs;
    2. PBs were first prescribed to those under the age of 16 under the Early Intervention Study, which took place between 2011 and 2014. The full results of this study had still not been published;
    3. Data had not been collated of the age distribution of those referred for treatment with PBs in the years 2011-2020. In 2019/20 over 50% of those referred were under the age of 16;
    4. There had been a significant increase in referrals to GIDS in recent years. The number of referrals had risen by a factor of ~26 between 2009 and 2018.  During approximately the same period the gender divide in patients being referred had changed from 50:50 to 76% in favour of natal girls.  D did not propose a clinical explanation for these changes;
    5. There was some evidence of a link between ASD and gender dysphoria. D was unable to provide data on the percentage of those being referred for PBs with comorbid ASD;
    6. D’s policy was for a young person to be referred for PBs only if clinicians were satisfied that the individual was capable of giving informed consent (known as being Gillick competent: see paragraph 15 below). Side effects and consequences of treatment, for example for fertility and sexual functioning, were discussed with the young person over a number of sessions as part of a “discursive and iterative” process;
    7. D could not provide data showing the proportion of young people who were assessed as suitable for PBs, but were not prescribed them because they were considered not to be Gillick competent. The Court concluded (para 44): “it was extremely unusual for either GIDS or the Trusts to refuse to give PBs on the ground that the young person was not competent to give consent.”

The decision

15. The leading case on minors’ capacity to consent to medical treatment remains Gillick v West Norfolk and Wisbech Health Authority [1986] AC 112. The House of Lords ruled that a child under the age of 16 could lawfully consent to medical treatment without a parent’s involvement if she had sufficient maturity and intelligence to understand the nature and implications of the proposed treatment (now referred to as “Gillick competence”).

16. The Divisional Court at paras 126-132 summarised the principles applicable to the present case:
    1. Gillick competence depended on the nature of the treatment. In the case of life-changing treatment there was a greater onus to ensure that a child was able to understand and weigh the information;
    2. An individual’s personal characteristics were of relevance. The Court was nonetheless able to  draw some lines as to the age at which a child would be able to give informed consent;
    3. In determining what level of understanding was sufficient, it was necessary to have regard to matters which objectively ought to be given weight in the future although the child might be unconcerned about them now. Examples of such matters included the treatment’s impact on fertility and sexual functioning.

17. Central to the Court’s conclusion were its findings regarding the treatment of PBs for gender dysphoria. It ruled that:
18. 1. There was very limited evidence of the treatment’s efficacy and there was real uncertainty over its consequences, in the short- and the long-term. It was thus an experimental treatment;
    2. There was a lack of clarity over its purpose;
    3. The treatment had highly complex and potentially life-long and life-changing consequences, which went to the heart of a person’s identity;
    4. The medical treatment was an unusual one, as it had direct physical consequences, but was intended to treat a condition without any physical manifestation.

18. D’s submission that the treatments of PBs and CSH were entirely separate was rejected. The two treatments were to be regarded as sharing a single clinical pathway since a child who commenced treatment with PBs almost always progressed to treatment with CSH.

19. The Court saw merit in the Claimants’ argument that for some children the prescription of PBs supported the persistence of gender dysphoria. It concluded that the use of PBs was not a neutral process, since it prevented the child experiencing puberty as part of the normal biological process, a process which would contribute to the child’s understanding of their identity.  They were also to be viewed as a stepping stone to treatment with CSH.

20. The Court gave an extensive list of the information which a child, in order to achieve Gillick competence, would need to understand, retain and weigh up (para 138):
21. 1. the immediate consequences of the treatment in physical and psychological terms;
    2. the fact that the vast majority of patients taking PBs go on to CSH and therefore that s/he is on a pathway to much greater medical interventions;
    3. the relationship between taking CSH and subsequent surgery, with the implications of such surgery;
    4. the fact that CSH may well lead to a loss of fertility;
    5. the impact of CSH on sexual function;
    6. the impact that taking this step on this treatment pathway may have on future and life-long relationships;
    7. the unknown physical consequences of taking PBs; and
    8. the fact that the evidence base for this treatment is as yet highly uncertain.

21. The Court further gave clear guidance on whether children of different ages were likely to be Gillick competent:
    1. “…in many cases, however much information the child is given as to long term consequences, s/he will not be able to weigh up the implications of the treatment to a sufficient degree. There is no age appropriate way to explain to many of these children [at GIDS] what losing their fertility or full sexual function may mean to them in later years.”
    2. it was highly unlikely that a child under 14 would ever be Gillick competent;
    3. it was unlikely, although possible, that a child aged 14 or 15 would be Gillick competent;
    4. whilst 16- and 17-year-olds were presumed to have mental capacity[2], a Court should be involved if the clinicians had any doubt as to what was in the child’s best long-term interests.

22. The Claimants’ alternative ground, that the information provided was inadequate to form the basis of informed consent, was rejected.

Comments

23. It is striking from the judgment (see paragraphs 13 and 14 above for the key points) that D had not been collating all possible data which arose from the prescription of PBs for gender dysphoria, a novel medical treatment. The Divisional Court three times in the judgment records its “surprise” (thinly veiled dismay) at D’s failure to investigate fully the impact of the subject treatment.

24. The limits of the data provided contribute to the Court’s damning conclusion regarding the nature of PBs as a treatment for gender dysphoria: that there is limited evidence of their efficacy, a lack of clarity around their purpose, and that they may have life-changing consequences for patients. The Court further notes that they are an unusual medical treatment and expresses sympathy for the Claimants’ argument that they may cause a young person’s gender dysphoria to persist.  These are strong words from the Divisional Court which will give pause for thought to medical practitioners in this area.

25. The impact of the judgment has been immediate: within the NHS, referrals by GIDS for PBs for patients under the age of 16 have been temporarily suspended and a full clinical review has been ordered for all those under the age of 16 who have been receiving PBs. In future the question of whether PBs are an appropriate treatment for under 16-year-olds will in most cases be decided by the High Court under its inherent jurisdiction over medical treatment for those under the age of 18.  Although the Court accepted that 14- and 15-year-olds might have Gillick competence to choose to undergo treatment with PBs, I suggest that the list of information which a young person must be able to weigh up (paragraph 20 above) is a formidable one, and medical practitioners will be cautious not to misjudge whether a young person has capacity.

26. Equally, it is anticipated that medical practitioners will be more cautious in prescribing PBs to 16- and 17-year-olds, given the judgment’s conclusion that there should be recourse to the Court if there is any doubt that the treatment is in the individual’s best interests. Clinical decisions as to whether PBs are appropriate are difficult; this judgment’s expression of concern about the treatment, and the need (in many cases) to involve the Court, will prompt clinicians to reflect carefully on the reasoning behind their recommendations and be transparent regarding the same.

27. One option available to D, which would (arguably) avoid the need to involve the Court, would be to rely upon the parents’ consent instead of the young person’s informed consent. This possibility was not ruled upon by the Court (para 47).  In the light of D’s firmly articulated policy of requiring a patient’s consent, it is perhaps unlikely that they would pursue such a course.

28. Finally, should we expect civil claims to be brought by young persons treated with PBs or other gender reassignment treatment? The present case was a judicial review and did not address the question whether clinicians breached their duty of care to patients.  Nonetheless the High Court’s findings about the experimental nature of PBs and their limited evidential basis may, I suggest, prompt former patients dissatisfied with their treatment to consider the option of a clinical negligence claim.  All will depend on expert evidence regarding breach of duty.

[1] As defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

[2] Section 8 of the Family Law Reform Act 1969.