Judicial Review of Private Puberty Blocker Restriction

What's being argued?

When the final report of the Cass Review was published, the UK government took action to restrict the prescription of puberty blockers to under 18s in England and Wales. The NHS changed its own policies in light of the findings of the review and, in addition to this, the Secretary of State for Health and Social Care, Victoria Atkins, made an emergency order to restrict provision of puberty blockers by private prescription to new patients. The order is temporary, operating from 3 June 2024 until 3 September 2024 and applies to both domestic and overseas prescriptions.

Transactual, an advocacy group is acting with an anonymous claimant, YY, described as a young trans person to challenge the lawfulness of this order. They are supported by the Good Law Project. The case is being heard today and is being reported contemporaneously by Tribunal Tweets.

This is a judicial review, which means that the challenge is to the lawfulness of this order, not its merits. It will not be sufficient for Transactual to argue that this order is bad policy or that an alternative approach to implementing the Cass Review is more prudent. It must point to how the Secretary of State has acted unlawfully in making this order.

The Claim

In its pre-action letter, the Good Law Project set out the main grounds for challenging the lawfulness of this order:

1. The Secretary of State acted unlawfully in utilising the emergency process under s.62(3) of the Medicines Act 1968 to make the Order and/or

2. The Secretary of State carried out a partial and unfair consultation process in failing to consult the Claimant or any similar organisation which represented the interests of patients affected by the Order.

Under s.62 of the Medicines Act 1968 the Secretary of State may make an order prohibiting the sale of medicinal products. Transactual are arguing that the conditions set out in the Act for making such an order were not met and that the order was therefore unlawful. Here is the provision in full:

The first condition that must be met here is that the Minister must be satisfied that it is necessary in the interests of safety to make the Order. In my view, the Cass Review provides ample basis for this condition to be met and it would be very difficult to argue that relying on the Cass Review would render the making of this Order unlawful on the grounds that this is not sufficient evidence to support the conclusion that it is necessary in the interests of safety.

Additionally, there is an obligation before making an order to consult the appropriate committee. The Good Law Project have argued that as a result of the decision to use the emergency process, Atkins “failed to consult with the Commission on Human Medicines as is requires under s.62(1) of the Act before making the Order”. But the Act only places this requirement to consult where the Minister is not of the opinion that “it is essential to make the order with immediate effect to avoid serious danger to health”. So the Claimant must argue either that the conclusion that it is essential to make this order with immediate effect was so unreasonable as to be unlawful or that the requirement that Atkins be satisfied that it is essential has not been met because of some other failure.

The letter before action also argued that the Secretary of State “failed, contrary to s.129(6) of the Act, to consult with the Claimant or any similar organisations representative of the interests likely to be substantially affected by the Order”. That provision provides:

Before making any regulations under this Act and before making any order under this Act (except an order made in accordance with any provision of this Act under which, in case of urgency, an order can be made with immediate effect) the Ministers proposing to make the regulations or order shall consult such organisations as appear to them to be representative of interests likely to be substantially affected by the regulations or order.

So again the consultation requirement only obtains where an order is not being made in case of urgency with immediate effect.

Similarly, the Claimant argues that the Secretary of State failed to provide it or similar organisations with any opportunity of making representations or being heard by the Commission on Human Medicines as required by s.62(5). But again, that obligation only obtains where an order is not being made with immediate effect on grounds of urgency. This order was made with immediate effect on grounds of urgency.

So the central challenge that will be made here is that the Order is unlawful because the condition needed to be satisfied in order for it to be made under the emergency process has not been met. That condition is that the Secretary of State is satisfied that it is essential to make the order with immediate effect to avoid serious danger to health.

It must be stressed again that it will not be sufficient to establish that the Claimant or even the Court would have made a different decision if they were the Secretary of State for Health and Social Care. The legal test here is whether the Minister acted unlawfully, not whether she made a bad decision. That is a high bar to meet. If there are plausible, defensible, grounds to conclude that it was essential to make this order with immediate effect to avoid serious danger to health, then a Court will be reluctant to overturn the Order. In my view, although we have not see the full hearing yet, I would be surprised if the Court concluded that the Cass Review does not provide sufficient grounds to make this Order.