Transactual CIC & Anor, R (on the application of) v Secretary of State for Health and Social Care & Anor

Under section 62 of the Medicines Act 1968, Ministers may prohibit the supply of medicines where this appears necessary in the interests of safety. The emergency procedure may be used where Ministers reasonably consider that immediate action is essential to avoid serious danger to health. The precautionary principle applies despite scientific uncertainty, particularly where vulnerable patients and potential health risks are involved.

The court should apply anxious scrutiny but afford restraint to a ministerial decision involving scientific evidence, clinical judgment and competing predictive assessments. The statutory emergency exemption removes the duty to consult imposed by the ordinary procedure. Informal stakeholder engagement after an in-principle decision is not a legally effective consultation. Article 8 does not impose a general duty to consult individuals before legislating on healthcare policy.

The claimants challenged an emergency prohibition order and related NHS regulations restricting the prescription, sale and supply of puberty blockers for gender dysphoria or gender incongruence in persons under 18. The claimants alleged that the emergency procedure under section 62(3) of the Medicines Act 1968 was unavailable, that the consultation process was unlawful, and that failure to consult affected individuals breached Article 8 ECHR.

The defendants relied on the Cass Review, concerns about the evidence base and risks of puberty blockers, and the activities of overseas prescribers. The central issues were whether the emergency statutory test was met, whether any consultation duty arose, and whether Article 8 required consultation before the legislation was made.

1. Ground 1 failed. Sections 62(1) and 62(3) of the Medicines Act 1968 required the defendants to determine, respectively, whether restrictions were necessary in the interests of safety and whether immediate action was essential to avoid serious danger to health. “Necessary” imposed a high threshold and “essential” an even higher one.
2. The precautionary principle applied. The defendants were entitled to act on powerful scientific evidence identifying very substantial risks, very narrow or unproven benefits, and substantial uncertainty about longer-term effects. The Cass Review was the best and most up-to-date scientific evidence available. A conclusive demonstration of actual harm was unnecessary.
3. The decision was reviewable for rationality and required anxious scrutiny because gender identity issues could engage Article 8. However, the statutory criteria involved an inherently imprecise, complex and multi-factorial predictive assessment involving clinical judgment and competing risks. The court therefore exercised restraint and did not second-guess a rational ministerial assessment.
4. The First Defendant was rationally entitled to conclude that immediate action was essential. The standard consultation and CHM process was estimated to take five to six months, during which overseas providers might continue prescribing contrary to the Cass Review and NHS policy. The exceptions for existing patients did not undermine the decision; they reflected a different balance of risks for patients already receiving treatment.
5. Ground 2 failed. Discussions with stakeholders before the in-principle decision were ordinary exchanges of views, not consultation. After the decision had been taken, the truncated engagement exercise concerned implementation and could not satisfy the Gunning criteria. In any event, the statutory emergency exemption meant that no common law consultation duty could be implied.
6. Ground 3 failed. Article 8 was engaged, but it did not impose a general duty to consult individuals before legislation affecting healthcare policy. Parliament had provided a limited statutory consultation scheme and an emergency exemption. The court declined to superimpose wider procedural safeguards.
7. Permission was granted on all three grounds, but the claim for judicial review was dismissed.