Question to the Department of Health and Social Care:

To ask His Majesty's Government what plans they have to ensure that children with existing bone health issues will not be recruited to the PATHWAYS puberty blockers trial.

The Medicines and Healthcare products Regulatory Agency and the Health Research Authority have approved a research protocol for the PATHWAYS clinical trial, setting out the clinical and research eligibility criteria for participation, including exclusion and discontinuation criteria relating to bone density, and the full range of necessary information for participants and their parents on issues such as fertility preservation.

The protocol also sets out the extensive care and monitoring that will apply both within and after the clinical trial. Once the initial period of the study is complete, all trial participants initiated on puberty suppressing hormones as part of the trial will be monitored via an open label, non-randomised extension of the current study. The National Institute for Health and Care Research has committed to funding this extension, subject to normal scientific review.

The Government is clear that people should only take prescription-only medicines that have been prescribed and dispensed by an appropriately qualified and licensed healthcare professional. Since 1 January 2025, restrictions on the sale and supply of puberty blockers via private prescriptions have been made indefinite. This legislation ensures that children will not be exposed to the unsafe prescribing of puberty blockers, and was introduced in response to recommendations in the Cass Review and following expert advice from the independent Commission on Human Medicines.

Children and their families are also strongly discouraged from sourcing any medication from unregulated or online providers that are not regulated by United Kingdom bodies. Where offences against this legislation are committed in the UK, the appropriate regulator can investigate and, where necessary, take action.