GPs should refuse shared care with ‘unregulated providers’ for prescribing all hormone medication to children with gender incongruence, NHS England has instructed.
In new guidance circulated to GPs this month, NHS England emphasised that services not regulated by the CQC or Health Inspectorate Wales ‘pose a risk to patient safety’ as they are ‘not subject to the same level of scrutiny’.
NHSE said the guidance is in response to concerns raised by GPs and ICBs about unregulated providers arranging for puberty blockers and other hormone drugs to be given to children for gender incongruence.
The national commissioner highlighted that private prescribing of puberty blockers (GnRH analogues) has been banned by the Government since 3 June 2024, while prescription of puberty blockers on the NHS stopped in March last year.
These decisions were based on the ‘lack of evidence about safety, risks, benefits and outcomes’, the new guidance said.
NHS England has also accepted the Cass review recommendations on exogenous hormones – used for the purpose of masculinisation or feminisation – meaning they cannot be prescribed to children under 16, and only to 16- and 17-year-olds where doctors ‘can demonstrate extreme caution in clinical decision making’.
Based on this, NHS England has now told GPs that they:
- must refuse to support the private prescribing or supply of GnRH analogues;
- should refuse to support an unregulated provider in the prescribing or supply of alternative medications that may be used to suppress pubertal development;
- should refuse to support an unregulated provider in the prescribing of exogenous hormones.
The guidance said: ‘Where a medical intervention as a treatment option for gender dysphoria or gender incongruence is proposed for a child or young person under 18 years by a healthcare professional working for / with an unregulated healthcare provider, the absence of regulatory oversight should reasonably cause a GP to decline a proposal for a shared care arrangement.’
GPs should heed this advice with ‘any unregulated provider’ in the gender dysphoria or incongruence field – but NHSE also ‘specifically cautioned’ against GenderGP and Anne Transgender Healthcare Ltd.
NHS England said these two specific providers have ‘published statements that oppose the restrictions’ put in place by both NHS England and the Government with regard to puberty blockers.
Both providers offer services to UK patients but are either registered overseas or operate their clinical team overseas.
In the case of GenderGP, NHS England highlighted that ‘past regulatory action and judicial rulings’ suggest its activities ‘may present an ongoing safety risk to children and young people in the UK’.
The guidance cited a High Court judgement from 2024 which found that said evidence provided ‘gives rise to additional serious concerns as to the safety of patients accessing cross-hormone treatment from that particular clinic’.
NHSE advised GPs that ‘as a general principle’ they should consider each shared care request on a ‘case-by-case basis’ to ensure the request is from a ‘reputable company’.
When refusing shared care for prescribing exogenous hormones, NHSE said GPs should advise the young person and family ‘against sourcing medications from the provider’.
The guidance added: ‘If the GP has concerns that declining responsibility would pose a clinical risk to the child or young person, the decision to decline a shared care agreement should be weighed against the ongoing risk posed by administration of a medicine from an unregulated source. In such cases, consider a referral to appropriate local services.’
Advice if ending an existing share care arrangement for exogenous hormones
- The young person and family should be advised against continued sourcing of medications from the provider, and the risks explained to them.
- The GP should inform the unregulated provider and the young person / family in writing that the shared care agreement is no longer in place.
- Where the young person or family decide to continue with the medication contrary to the GP’s advice, the GP should arrange for a final set of test results to be sent to the provider that is prescribing, with a written request for that provider to establish alternative means of regular monitoring and testing. This approach is consistent with the general principle that clinical responsibility for prescribing is held by the person signing the prescription, who must also ensure adequate monitoring.
- The GP should consider the individual’s need for further professional support, such as a referral to children and young people’s mental health services and / or to the specialist NHS gender pathway.
NHS England also acknowledged that waiting times for the NHS Children and Young People’s Gender Service are ‘expected to remain long while the NHS builds additional clinical capacity’.
But it warned that sourcing medications from unregulated providers ‘cannot be defended as an appropriate response’ to these long waiting times.
A spokesperson for NHS England said: ‘Unregulated healthcare services pose a risk to patient safety as they are not subject to the same level of scrutiny as registered services.
‘In response to concerns put to NHS England by GPs about named unregulated providers who arrange for puberty blockers, hormone drugs and other medications to be given to children for gender incongruence, contrary to NHS policy, NHS England has advised GPs not to cooperate in this unsafe practice.’
Anne Trans Healthcare put out a statement in response which said NHS England’s new guidance ‘frames care as risk rather than relief’ and instructs GPs ‘not just to step back – but to walk away’.
The company continued: ‘The medical professionals we work with are regulated, and clinical experts in trans healthcare in their countries. Our patients speak directly to their clinicians. Their monitoring, including that of the mandatory blood tests, is done by those same clinical experts.’
The provider also said the reason it exists is ‘because the NHS has failed trans people for years’.
What are the Medical Defence societies positions on this?
What an absolute contradiction to what the GMC said (below) just 9 years ago with no reference to age of patient or the status of the specialist.
For my pat very glad to have retained some logical consistency throughout, and refused the ICB pressure to prescribe that the GMC gave rise to. In my unequivocal responses to the ICB I made clear that the GMC had adopted a stance completely at odds with its other guidance on safe prescribing and responsibility. My most generous assumption is the GMCs cognitive dissonance can only have been a product of forceful lobbying of weak minds by special interest groups. There are less generous interpretations easy enough to come to.
“The GMC’s Guidance for Doctors Treating Transgender Patients (March 2016):
“…..You must co-operate with Gender Identity Clinics and gender specialists in the same way that you would co-operate with other specialists, collaborating with them to provide effective and timely treatment for trans and non-binary people. This includes: prescribing medicines recommended by a gender specialist for the treatment of gender dysphoria; following recommendations for safety and treatment monitoring; making referrals to NHS services that have been recommended by a specialist.
Once the patient has been discharged by a Gender Identity Clinic or gender specialist, the prescribing and monitoring of hormone therapy can be carried out successfully in primary care without further specialist input. From the patient’s perspective, management in primary care is far easier, and there is no specific expertise necessary to prescribe for and monitor patients on hormone therapy. …….”
Yep GMC were part the problem on this issue.