A ban on the sale and supply of puberty blockers has been made indefinite following a consultation, the Department of Health and Social Care (DHSC) has announced.
The ban applies to the supply of gonadotrophin-releasing hormone (GnRH) analogues to patients aged under 18 years for the treatment of gender incongruence and/or gender dysphoria. It will come into force on 1 January 2025, when the current emergency order expires.
It does not apply to patients who are already receiving these medicines on the NHS, or to those taking them for other reasons.
In March 2024, the NHS stopped routine prescriptions of puberty blockers to patients aged under 18 years, in response to an evidence review by the National Institute for Health and Care Excellence. The findings were echoed in the Cass review of gender identity services, published in April 2024.
Then, in June 2024, an emergency three-month order banned private or overseas prescriptions of the medicines. The ban was renewed two more times, with the latest order set to expire on 31 December 2024.
In a statement published on 11 December 2024, the DHSC said that the Commission on Human Medicines (CHM) had provided “independent expert advice that there is currently an unacceptable safety risk in the continued prescription of puberty blockers to children. It recommends indefinite restrictions while work is done to ensure the safety of children and young people”.
The statement added that the legislation would be reviewed in 2027.
Wes Streeting, secretary of state for health and social care, said: “Children’s healthcare must always be evidence-led. The independent expert CHM found that the current prescribing and care pathway for gender dysphoria and incongruence presents an unacceptable safety risk for children and young people.”
Hilary Cass, author of the Cass Review, said: “Puberty blockers are powerful drugs with unproven benefits and significant risks, and that is why I recommended that they should only be prescribed following a multidisciplinary assessment and within a research protocol.
“I support the government’s decision to continue restrictions on the dispensing of puberty blockers for gender dysphoria outside the NHS where these essential safeguards are not being provided.”
Speaking in the Houses of Parliament on 11 December 2024, Streeting said that it was “worth pointing out that breach of the order is a criminal offence under the Medicines Act 1968″.
“That means pharmacists who dispense medicines against prescriptions that are not valid may be liable to criminal prosecution,” he added.
In a statement published in July 2024, the Royal Pharmaceutical Society (RPS) said it was “concerned about the potential criminalisation of pharmacists who dispense these medicines” and called for patients to have “timely access to specialist care pathways for support”.
Commenting on the indefinite ban, Wing Tang, head of professional standards at the RPS, said: “We acknowledge the government’s confirmation they will make the ban on puberty blockers indefinite, which brings clarity to the situation.
“We note that the risks of the criminalisation of pharmacists, including inadvertent criminalisation, were considered as part of the consultation process but are disappointed that this issue remains.
“We urge the government to consider a solution which protects patients and provides them with the support they need but doesn’t unfairly criminalise pharmacists.”
In its statement, the DHSC said that the National Institute for Health and Care Research is working with NHS England on plans for a clinical trial to look at the effectiveness of puberty suppression and the safety of prolonged treatment, as recommended by the Cass Review. It aims to recruit the first patients by spring 2025.
It added that targeted mental health support will be made available from local NHS services to anyone affected by the order.