Puberty Blockers Trial: Consent

Question

Asked by

To ask His Majesty’s Government at what age they consider it appropriate for an individual to be able to consent to the administration of puberty blockers on a trial basis.

My Lords, in begging leave to ask the Question standing in my name on the Order Paper, I declare an interest as former chair of the Human Fertilisation and Embryology Authority.

My Lords, the PATHWAYS trial entry age was recently reviewed by the MHRA and the sponsor, resulting in a minimum age of 11 for females and 12 for males. It aims to study treatment when it is most clinically relevant while safeguarding participants. Eligibility is tightly controlled; it requires parental consent, a minimum two-year gender incongruence diagnosis, psychosocial support, and NHS and multidisciplinary team approval, as well as participant understanding of the risks and benefits, physical and mental stability, and compliance with safeguarding requirements.

My Lords, how can the Minister justify the age of 11 for a puberty blocker trial? A child under 16 cannot consent to sex or to medical treatment if they are not Gillick competent. They cannot join the Army, smoke, take drugs or alcohol, or even watch social media soon. We condemn FGM, but here is something much more profound. I ask your Lordships to think back to when you were 11—did you understand what it meant to be a woman or a man? The children in this trial are utterly unable to give meaningful consent.

A trial of just two years will tell us nothing. We need retrospective evidence from those who have already taken these drugs. It is only when they reach middle age that those experimented-on children might reflect on whether it would have been better to have been fertile, to have had fulfilling, intimate relationships and to have been themselves. I predict litigation on the scale of infected blood. The first principle of medical ethics is, “Do no harm”. This trial cannot avoid doing harm. I think parents will join me in asking the Minister to stop it.

I appreciate that the noble Baroness has strong views—so do a number of noble Lords, as we heard on the Statement that I presented and responded to yesterday. On consent, I remind noble Lords that this is a sensitive, emotive and difficult subject, but that is why we have to be driven, as the previous Government were, by clinical evidence and experts. I recall that the noble Baroness, Lady Cass, who was rightly entrusted with an independent review, said:

“This is an area of remarkably weak evidence”.

There are always choices. We could continue with uncertainty and risks to the safety of children and young people, which I think none of us wants, or undertake a scientifically guided trial for 233 children, with all the right safeguards that I have referred to, and protect children and young people.

My Lords, am I right that these drugs are also sometimes necessarily available to quite young people who might otherwise go into premature puberty, with serious health results? With gender dysphoria, is it not better that we look into the possible use of these drugs rather than have children and young people fixate on surgery, which is much harder to stop or reverse?

My noble friend is quite right about the use of these drugs. It is important to note that we banned their use indefinitely for gender dysphoria outside of research settings because of the immense concerns about safety. That ban has been in place since January 2025. She is also right that the issue will not go away. The right way to protect children, as I have said, is to act on clinical evidence and opinion, and to make that decision with a cool head. That is why, despite the difficulty of such a decision, the Secretary of State has made it. He is doing the best he can to protect children in this situation.

My Lords—

My Lords—

My Lords, we will hear from the Liberal Democrats.

My Lords, the review from the noble Baroness, Lady Cass, warned that having no formal medical routes risks driving families towards unregulated online pharmacies and private clinics abroad. Given that an indefinite pause of the trial left some highly vulnerable young people in a state of clinical limbo, does the Minister agree that getting an evidence-gathering trial under way would be an effective way to protect them from the dangers of these unregulated and unmonitored markets?

I certainly do agree. As I have said, having put a ban in place, we will take action against those who seek to transgress and benefit from it by seeking to sell drugs that are not permitted. That is a totally unacceptable route for them to follow. They risk the safety and well-being of children.

My Lords, yesterday the Minister told the House that the PATHWAYS trial would be covered by insurance. I have been unable to identify any insurance company that will cover such treatment, even in a trial setting, so can she tell us how insurance has been obtained, the information on which it is based and from which provider it has been obtained? I appreciate that this may not be possible in the Chamber due to time, but I would be grateful to see the information provided in detail and the terms of the policy.

Although I am keen to be helpful to the noble Baroness, my comments yesterday related to trials and insurance provisions. I do not know what research has been undertaken since then. I would be pleased to write to her; I cannot promise the detail she seeks, but I will seek to be helpful.

My Lords, I have spoken to my clinical colleagues about the issue of age at enrolment and they expect enrolment at 11 or 12 to be vanishingly rare. However, I ask noble Lords to consider the case of a child I will call Jo, who was a biological male socially transitioned at two and a half by his parents. At 11, she—I say this advisedly, because the chances of her reverting to her biological gender are vanishingly remote—has been in stealth and will not go to secondary school because she is so afraid of being outed in that environment. She is now refusing to come out of her room except very rarely and has weak bones, not as a result of puberty blockers but through inactivity. Should her subsequent treatment be decided by politicians or by the clinicians looking after her?

The noble Baroness brings her expertise to the subject and I am grateful to her. This is not a political matter. As I have said, it must be driven by clinical evidence and focus on the safety of our young people. The example she gave is deeply disturbing and is a result of not taking action that is evidenced.

My Lords, the only thing that matters in this instance is the right of the child to the best and most appropriate treatment. Therefore, does the Minister agree that puberty blockers are used for a range of conditions and that any approach must therefore be based solely on the recommendations of the multidisciplinary team, the clinicians involved and the needs of the patient?