The following Answer to an Urgent Question was given in the House of Commons on Wednesday 17 December.
“Let me just start by acknowledging the sensitivities around this issue and the strong beliefs held around this House. For all the division and divided opinion, I believe that there is a determination shared by everyone in this House to do the right thing by a vulnerable group of children and young people. It is for those reasons that I am taking the course of action that I am. Put simply, that is to follow expert clinical advice and take an evidence-led approach.
The Cass review found shocking levels of unprofessionalism, a lack of clinical oversight and puberty blockers prescribed to children without sufficient evidence that doing so was safe or beneficial to those children and young people. What Dr Hilary Cass uncovered was a scandal. That is why, on coming to office, I made the temporary ban brought in by my predecessor, the right honourable Member for Louth and Horncastle, Victoria Atkins, a permanent one. Dr Cass also recommended a thorough study to establish how best to support children and young people who suffer gender incongruence. That is the PATHWAYS study.
The study has four main parts, one of which is the clinical trial to study the effects of puberty-suppressing hormones on young people’s physical, social and emotional wellbeing. The other aspects of the PATHWAYS study will track the physical, social and emotional well-being of all young people attending UK NHS gender services. It will look at young people’s thinking and brain development, following both those who are and are not taking puberty-suppressing hormones, and it will gather evidence directly from young people, parents and staff about their experiences of living with gender incongruence.
The bar for the trial to be approved was extremely high and oversight will be rigorous. Children cannot consent to being on the trial, so places will require parental consent, as well as the assent of young people. It is because protecting and promoting the health and well-being of affected young people is our primary concern that there are also strict eligibility criteria in place to join the PATHWAYS clinical trial. As such, the number of young people who would expect to qualify for the trial will also be low. Participants must undergo thorough mental and physical assessments and will be followed over a number of years with regular well-being checks. Puberty blockers have also been used to delay puberty in children and young people who start puberty much too early. Use in those cases has been extensively tested and has met strict safety requirements for that use.
The study is led by King’s College London and the South London and Maudsley NHS Foundation Trust. It has been carefully checked by independent scientists who advise the National Institute for Health and Care Research and by the Medicines and Healthcare products Regulatory Agency, and received approval from a research ethics committee. I am treading cautiously in this area because the safety of children must come first”.
My Lords, I begin by thanking the Government for their sensitive language in handling this delicate issue. I recall the noble Baroness, Lady Cass, telling the House that puberty blockers are currently licensed only for much younger children with precocious puberty or older adults with certain cancers. Trials are therefore needed to determine whether they are safe for adolescents with gender incongruence and to understand the interaction with the different processes of puberty. I understand that children taking part in the trials must have their parents’ consent, but can the Minister clarify two points that are clearly raising concern? First, what is the maximum and minimum age of children taking part in these trials? Secondly, what assurances can the Government definitively give that children taking part in these trials will not experience fertility issues or loss of sexual function or any conditions that are irreversible later in life? I also wish all noble Lords, staff and officials a merry Christmas, happy Hanukkah, happy new year and, as our American cousins say, happy holidays.
My Lords, I am grateful to the noble Lord for acknowledging the sensitive language. This is indeed a sensitive issue. For all the division and divided opinion that I know there is, there is also a determination—including across the House, I am sure—that we get this right. The clinical trial is just part of the PATHWAYS study. With regard to the clinical trial, it is extremely unlikely that anyone under the age of 11 will qualify as a potential participant and it runs up to the 16th birthday, so I hope that that is helpful. Can the noble Lord remind me of his second question?
I thank the noble Lord. Before participants enter the trial—and it is an extremely high bar, as it should be; there will be at least 226 participants required, but that is not a target and there will be no drive to get up to that number—certainly any possible impacts such as those the noble Lord describes will be fully discussed and mitigations will be explained and made available, particularly in terms of fertility. I absolutely take the point that the noble Lord raises.
My Lords, we are faced with a situation where, for 15 years, clinicians in this country have told children and young people that these medications are safe, fully reversible and indeed life-saving. Last year, they were rightly banned from clinical practice. However, the upshot is that now, of the 75 children a month who are coming to the new services, about 20% are getting these medications and, worse, testosterone and oestrogen from unlicensed and unregulated sources—and those are the ones we know about. In addition, referrals to the new services have dropped from 200 a month to only 30 a month, so we think that a large number of those young people are also being harmed through those mechanisms.
We are concerned about this much broader harm; children are voting with their feet now. Does the Minister agree with me that, for the very tiny number of young people who clinicians believe will ultimately have a long-standing gender incongruence and will therefore be eligible for this trial, it is better that they get their medication under careful clinical supervision rather than on the dark web? Secondly, does she think that this trial will be a way of attracting that broader group of young people back into the NHS who do not need medical treatment but need holistic wraparound care?
Let me first say to the noble Baroness how grateful we are for her continued professional attention and sensitivity in dealing with this. There was a cross-party approach to the Cass review, and I pay tribute to Sir Sajid Javid, the former Health Secretary for seeing the need for this. We have always been supportive of the Cass review. I agree with both points that the noble Baroness has made. The fact is that this is about the need to face up to what the review found: shocking levels of unprofessionalism, a lack of clinical oversight and puberty blockers being prescribed to children without sufficient evidence. That was not safe and not beneficial and it could not go on.
My Lords, I first join my noble friend the Minister in congratulating the noble Baroness, Lady Cass, and I also congratulate my right honourable friend the Secretary of State, for the transparency with which this has already been dealt. Members will be aware that, across parties and across both Houses, there was a briefing that involved all the scientists who will be carrying out this research. Can my noble friend assure the House that that transparency and information giving will continue?
I can confirm to my noble friend that the transparency will continue and I am grateful for the comments that she made about my right honourable friend the Health Secretary, who I believe has not just been transparent but extremely honest. I very much welcome that.
My Lords, the backdrop to this research is an extensive international religious nationalist campaign against women’s rights and LGBT rights. Since this research has been designed according to standard research protocols, has been approved by the NHS ethics committees and will be carried out by professionals who are bound by professional regulation, does the Minister agree with me that those professionals should be enabled to get on with their job free from ideological interference?
I do agree with that point. We are seeking to protect the safety and interests of children and young people through evidence, and it is right and proper that we get on with that. As the noble Baroness has said, this is a trial; it is being led by King’s College London and the South London and Maudsley NHS Foundation Trust. It has been carefully checked by independent scientists who advise the NIHR and by the MHRA and it has also received approval from a research ethics committee. I would say that we are treading cautiously and correctly in this area, because all that matters is the safety of children.