Secreatry of State for Health and Social Care (): I am today updating the House on the Government's
efforts to provide better outcomes for children and young people
with gender incongruence, in line with the recommendations of the
Cass review.
Children's healthcare must always be led by evidence and
medicines prescribed to young people should be proven to be safe
and effective.
The Cass review was clear that there is not enough evidence about
the long-term effects of using puberty-suppressing hormones to
treat gender incongruence to know whether they are safe or
beneficial. It is a scandal that medicine was given to vulnerable
young children without proof that it was safe or effective, and
outside the rigorous safeguards of a clinical trial.
The review recommended that a clinical trial be commissioned
within a full programme of research, which is being taken
forward. This is the safest and most effective way of building an
evidence base and charting a course through this challenging
issue, where there are understandable concerns around safety,
efficacy and consent. The Commission on Human Medicines (CHM) – a
statutory, expert body made up of clinicians and academics which
provides independent advice to Ministers on the safety, efficacy
and quality of medicines - considered information on the proposed
trial and made recommendations which have been adopted
On Saturday, following the receipt of full ethical approvals from
the MHRA and the Health Research Authority, King's College London
launched two new studies funded by NHS England to provide better
evidence for how the NHS can support and treat young people with
gender incongruence.
This includes the PATHWAYS trial, a carefully designed,
randomised controlled clinical trial of puberty suppressing
hormones for gender incongruence. This trial will involve young
people being treated in NHS Children and Young People's Gender
Services with a formal diagnosis of gender incongruence. It will
measure the impacts of these hormones on their cognitive,
physical, social and emotional well-being. For their own
well-being, there are strict eligibility criteria in place –
including clinical review and parental consent. Young people will
undergo comprehensive physical and mental health checks before
and during the study and will continue to receive psychosocial
and other non-medical care while participating. If a young person
meets the eligibility criteria, they will then be offered the
opportunity to participate in the trial. The study team are now
working to open sites for recruitment.
The trial has received comprehensive scientific, ethical and
regulatory approval from the MHRA and from the Health Research
Authority, including review by an independent Research Ethics
Committee. It follows the initiation of the observational
PATHWAYS HORIZON study, and has been approved alongside the
PATHWAYS CONNECT study. The health and wellbeing of the children
involved will always be our primary consideration.
NHS England has significantly increased both capacity and
investment since April last year, with the opening of three new
Children and Young People's Gender Services in London, the
North-West and the South-West. I am pleased to say a fourth
service will open in the New Year, with the ambition of service
provision in every region of England by 2026/27.
Last year, NHS England reformed the referral pathway in these
services. A referral can only be made by an NHS-commissioned,
secondary care-level paediatric service or a Children and Young
Person mental health service. This will ensure that healthcare
professionals with the relevant expertise conduct the assessment
and help determine any co-existing mental health or other health
needs of these children and their onward care.
I am determined to improve the quality of, and access to, care
for all trans people. The full implementation of the Cass review
will deliver material improvements in the wellbeing, safety and
dignity of trans people of all ages. I will continue to work to
help trans people live freely, equally, and with the dignity that
everyone in our country deserves.
