2024-08-01 20:02:25
On 31 May 2024, we reported on an emergency prohibition order regarding the prescribing of puberty blockers and NHS regulations preventing the prescribing of puberty blockers in England.
In The King (on the application of (1) Transactual CIC and (2) YY) v Secretary of State for Health and Social Care and another, [2024] EWHC 1936 (Admin), Mrs Justice Laing heard an application for judicial review of the temporary prohibition order on puberty-blockers that is due to expire on 2 September 2024 (though it is understood that the new Health Secretary intends to extend the order indefinitely). The order prevented pharmacists in Great Britain from suppling puberty blockers on prescriptions issued by prescribers registered in the EEA or Switzerland. The prohibition did not ban treatment where patient had started a course of treatment before the prohibition came into force. However, private prescriptions issued on or after 3 June 2024 could only be written by UK prescribers. The claimants also sought judicial review of NHS England’s decision not to allow doctors to prescribe puberty blockers on the NHS.
The first claimant is an organisation that supports transgender people in the UK. The second claimant is aged 15 and a transgender female who was in the process of acquiring her first prescription for puberty blockers from an overseas provider when the prohibition order was made.
The prohibition order was made under powers in section 62 of the Medicines Act 1968. Normally, the procedure for making an order required a consultation process, although regulation 62(3) refers to the power to make a prohibition order with immediate effect if, in the Minister’s opinion, it is essential to avoid serious danger to health. In this case, there had been no formal consultation and the claimants argued that this meant the prohibition order was unlawful.
Alternatively, the second claimant argued that the Secretary of State had breached Article 8 of the European Convention on Human Rights by failing to consult.
NHS England had commissioned the Cass Review which advised in July 2023 that because puberty blockers only had clearly defined benefits in quite narrow circumstances, and because of the potential risks to neurocognitive development, psychosexual development, and longer-term bone health, they should only be offered under a research protocol. The final Cass Report refers to concerns about the use of unregulated medicines (puberty blockers are prescribed off-label) and prescribing by unregulated practitioners, because EEA prescribers who are not based in the UK are not subject to the authority of UK regulators.
In dismissing the application for judicial review, Mrs Justice Laing J held:
- The Secretary of State was entitled, and indeed required to consider and assess the potential adverse risks of prescribing puberty blockers that were not licensed for treating children and young people for gender dysphoria in children and young people.
- The Secretary of State was entitled to take a precautionary approach.
- It was a matter for the judgement of Ministers to decide whether there was scientific uncertainty that meant that the normal consultation process should not be followed.
- The Secretary of State was entitled to conclude that the Cass Review was the most scientific evidence available, and further research on the effects and safety of puberty blockers for children and young people was not required.
- Following publication of the final Cass report, the Secretary of State was of the opinion that the evidence was sufficiently concerning to require an urgent change to the law, to avoid serious danger to health by preventing private and overseas prescriptions being issued to children and young people in the UK, which would evade the restrictions recommended by the Cass Review and implemented by NHS England.
- DHSC officials believed that, if there was a delay between the announcement of the prohibition order and the date it came into effect, patients would rush to beat the ban and try to initiate treatment, knowing that they would be allowed to continue once treatment had begun. The judge held that it was reasonable for the Secretary of State to accept this advice.
- It was essential to prevent continued prescribing by EEA prescribers to avoid serious danger to health as they would not comply with the recommendations of the Cass Review adopted by NHS England and the UK professional bodies.
- The argument the second claimant’s Article 8 rights failed because the European Court of Human Rights had never found that a State had breached Article 8 by refusing to authorise a particular type of medical treatment, even at an individual level, still less as a matter of general policy. It has repeatedly been held that matters of healthcare policy fall within a State’s margin of appreciation.