The SIs made by the Health Secretary took two different forms: one was a set of Regulations; the other was an Order. (Regulations typically set out substantive obligations, whereas Orders typically entail a one-off change. There is, however, no legal or procedural difference between them).

The Regulations: the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2024 (SI No. 728/2024) restricted new prescriptions of puberty blockers via NHS primary care (mainly GPs). These Regulations, which apply only in England, were made under powers in the National Health Service Act 2006. The Minister claimed that this SI simply brought the legislation in line with NHS clinical policy as the NHS had already stopped the routine prescription of puberty blockers to under-18s suffering from gender dysphoria following the Cass Review.

The Order: the Medicines (Gonadotrophin-Releasing Hormone Analogues) (Emergency Prohibition) (England, Wales and Scotland) Order 2024 (SI No. 727/2024) restricts the private sale or supply of puberty blockers. It is an Order made using powers in the Medicines Act 1968 and, as the title implies, it applies across Great Britain but not in Northern Ireland.

This Order is more controversial than the Regulations. It was made using a power in section 62 of the Medicines Act 1968 (as amended by the Medicines (Advisory Bodies) Regulations 2005) which allows the Minister to prohibit the sale or supply of medicinal products of any description or class specified in an Order.

In normal circumstances, to use the section 62 power the Minister must consult either the Commission on Human Medicines or a specially appointed expert committee, and then take any advice given by that relevant body into account. The Minister must also consult “such organisations as appear to them to be representative of interests likely to be substantially affected”.

However, there is an exception. If in the Minister’s opinion it is “essential to make the order with immediate effect to avoid serious danger to health”, then no consultation is necessary. It is this “serious danger to health” provision that the Health Secretary used to make the Order.

Within a week of both the Regulation and the Order being made, a legal challenge was brought by TransActual, supported by the Good Law Project. The High Court considered the matter at an expedited hearing on 12 July. The Court issued its judgment on 29 July, concluding that the Government had not acted unlawfully in utilising the emergency procedure to make the Order. Thus, the Court considered the SIs before MPs and Peers had had an opportunity to do so.

Both the Regulations and the Order are subject to the ‘made negative’ scrutiny procedure. Such SIs are ‘made’ (signed) into law before they are laid before Parliament and if neither House passes a motion to annul the SI - commonly known as a ‘prayer motion’ - within 40 days then they are deemed to have consented to them. However, the calculation of 40 days excludes periods of dissolution, prorogation and adjournments of over four days.

The dates both SIs came into force – 3 June for the Order and 26 June for the Regulations - fell during the period in which Parliament was dissolved for the General Election. There was thus no opportunity for parliamentary scrutiny of the SIs between the date they were laid and the dates they came into force.

With both Houses adjourning for the Summer recess on 31 July and returning on 2 September, before adjourning again for the party conference recess between 12 September and 7 October, the 40-day scrutiny deadline to revoke the SIs does not fall until 12 October, nearly five months after the Instruments were first made.

However, Orders made using the section 62 emergency provision in the 1968 Act can only remain in force for up to three months. After this, the new Health Secretary, Wes Streeting MP, must either let the policy fall away, make another temporary Order, or carry out the consultations required for a permanent prohibition on puberty blockers for under-18s.

The High Court judgment indicates that the new Government is “minded to renew the emergency banning order… with a view to converting it into a permanent ban, subject to appropriate consultation”. However, there is no indication that the Government has initiated the required consultations, so we may expect a further temporary Order to be made before the existing one expires. So long as the Minister continues to believe there is a serious danger to health, there is no statutory limit on the number of temporary Orders that can be made, potentially delaying the application of the consultation requirement far beyond the three-month limit.

The three-month limit means the emergency Order, which came into force on 3 June, expires on 2 September 2024 – the day both Houses return after the Summer recess. There is thus no time for MPs or Peers to consider that Order before it expires.

Furthermore, having been in force for three months it will expire well before the statutorily required 40-day scrutiny deadline of 12 October.

Does this matter? Previous Parliaments entrusted Ministers with powers in the National Health Service Act 2006 and the Medicines Act 1968 to exercise their judgement regarding the sale and supply of medicinal products. However, Parliament retained the power to scrutinise how Ministers exercise their judgement within the scope of the powers granted to them. The 40-day scrutiny period is the official route – set out in statute – for MPs to hold ministers to account for whatever actions they may take in the exercise of those powers delegated to them that are subject to the ‘made negative’ scrutiny procedure.

That statutory obligation to scrutinise is frustrated when an SI is in force, but the scrutiny clock is paused – as in this case for many weeks at a time - due to the exigencies of the parliamentary sitting calendar. It undermines the principle of parliamentary accountability.

There will always be occasions when the Government needs to implement an SI at great speed. Our Delegated Legislation Review has proposed that a new ‘urgent procedure’ should apply in all such cases. This would replace current arrangements set out on an ad hoc basis in particular Acts, with stricter safeguards, most notably that an urgent SI would automatically expire unless actively debated and approved by both Houses within 14 days of having been laid, with provision for a recall of Parliament if one or both Houses were in recess.

This would have meant that the previous Government could have made the puberty blocker Order if it were considered essential to do so immediately to avoid serious danger to health. However, a 14-day active approval period would have applied, rather than the 40-day negative consent scrutiny period. Taking into account the dissolution of Parliament, the Order under our proposals would have had to be approved in the days immediately after the King’s Speech and before the adjournment for the Summer recess, thereby providing for parliamentary accountability.

But rather than debating the politically and legally salient puberty blocker SIs, MPs found themselves debating the uncontroversial Global Combat Air Programme International Government Organisation (Immunities and Privileges) Order 2024 in the days between the King’s Speech and Summer recess. This demonstrates a further problem with the delegated legislation system: there is no sensible correlation between the content of an SI and the scrutiny procedure to which it is subject. Our Delegated Legislation Review has proposed that the scrutiny procedure for SIs should be determined not by the provisions of an Act perhaps decades ago (in the puberty blockers case the 2006 NHS Act and the 1968 Medicines Act which determined the provisions were subject to the ‘made negative’ procedure) but by a new ‘sifting committee’ of both Houses. Had the puberty blocker Order not been subject to the urgency provision, a sifting committee might have recommended that the time of MPs and Peers would be more productively spent debating it and the related Regulations, rather than debating the Global Combat Air Programme Order.

England, M. (9 August 2024), Puberty blockers legislation: has the parliamentary calendar undermined accountability?, (Hansard Society blog)