Today, I am updating the House that the preliminary work to establish the PATHWAYS clinical trial into the prescription of puberty suppressants for children and young people with gender incongruence has been paused.
The MHRA, the agency authorising the clinical trial, has written to the trial sponsors, King’s College London, to raise concerns regarding the trial which will now be discussed with clinicians. On Friday, DHSC published a copy of the MHRA letter, which is available here: Sponsor-letter110226.pdf.
Discussions between the MHRA and King’s College London will begin this week to address these new concerns. I will review the outcome of those discussions, taking clinical advice.
I have always been clear about the red lines regarding this trial and the prescription of puberty blockers – the safety and wellbeing of the children and young people and always being led by the expert clinical evidence. Those have been - and will remain - the driving considerations in every decision being made.
The clinical trial will not start to recruit until the issues the MHRA raised have been resolved. It will only be allowed to go ahead if the expert scientific and clinical evidence and advice conclude it is safe to do so.
https://www.theyworkforyou.com/wms/?id=2026-02-23.hcws1347.0
seen at 10:17, 24 February in Written Ministerial Statements.