Pathways Puberty Blocker Trial - High Court Proceedings start 27th July

[FarriersGirl]

James Esses, alongside the Bayswater Support Group and Keira Bell, is involved in a High Court hearing beginning on July 27, 2026, seeking an emergency injunction and permission for a judicial review regarding the "Pathways" puberty-blocker trial. The JR itself is likely to be heard in the autumn if it gets the go ahead.

Although we have had quite a few threads discussing the Pathways trial more generally I thought it would be useful to have one for the court case. I'm not sure if we will have access to watch/listen as the representative from the Bayswater Group has been granted anonymity.

From TT:

Indicated not approp to apply a heightened test (HT) to the roll up period.
The 3 reasons from Mass Energy at 363 - detailed argument. [missed]
Feeds into IP's skeletons. KCL & SLAM - gaps in knowledge can't reduce the public importance. Can't influence the test for permission. Weighs in favour of gart for permission (GFP). grant for permission.

J - we couldn't have ordered a rolled u hearing.
AM was ordered and derailed
that goes to test for interim relief IR.

Thank you for the c&p @FarriersGirl ❤️❤️❤️

Thanks @FarriersGirl. But crikey, I'm struggling to follow this! 😬

From TT:

J - approach the Ct takes at a 2 day hearing with thousands of pages of evidence is different from an half hour hearing. 2 days to look at points in detail. Better equipped to say whether arguable.

AM I accept that. A half hour hearing wld never have been approp. It is not a proxy for the substantive hearing (H).
J - - looks like something here. We'll see what the evid looks like. D & IPa have put in a lot of evid. Am I not entitled?

AM quite extraordinary for all that material to be so close to the hearing - colossal mass of evd. Has an effect on H that it's feasible to conduct.

From TT:

2 day hearing - but in compressed timetable and length of period envisaged for substantive consideration - 4 days - and consideration of injunction.
J - Understood.
J - standing?
AM - we approach in skel and subs - that threshold is arguarbility - not do justice to detail of args. So soon after service of documentary material. Ct prob has the bulk.
Standing - Apendix A - No point taken in relation to BSG.
Test is whether sufficient interest - KB and JE have to bring the proceedings - statement from KB - core bundle 2.

From TT:

page 110 - apparent an acute personal interest from her own experiences - Px PBs aged 16 then CXH at 17, breast surgery aged 20, and had previously involved in JR (BEll and Tavistock) relating to lawfulness of treatment of children with gender dysphoria or incongruence.
J reading.

AM - KB is evidently not in the busybody category - a C through her direct personal interest formed by her personal experience including having been through the Pathway. Recognised in JR proceedings in this area.

From TT:

AM _ JE Ws's [C2 126} sets out direct professional interest in bringing the claim.

We don't dispute the authorities. JE has sufficient interest and st to be recognised by the Ct.

AM - no challenge to BSG - so no impact on costs to recognising KB & JE - and no impact on costs of D or IP.

AM passes to Mr Henderson re reg 322, HMREgs 2012 - if it prevents a JR being brought.

MR H - Appendix B core bundle 1 p96 , para 7-12 MHRA gds of defence para 4-20 of MHRA skel

From TT:

Mr H - if MHRA is correct, this wld not be a partial ouster clause but a full OC. Wld remove any ct oversight other than challenge by {missed].

MR H - wording of reg, then partial ouster basis can be extinguished, then Medicines Act, and Provacy International, Ouster clause (OC) [missed]
Regs - read sub clause 1, 3, 4 ad 5 regs 322. Validity of decn not to be questioned in legal proceedings.

J - wording is same wording in [missed] - - talks abt partial OC. For purposes of this H you say arguable.
Mr H - shd not be a knock out point.

From TT:

J - partial OC - not exactly same wording - mmore similar to Privacy Int.
Mr H - yes - MHRA - series of POC cases. [case name missed east...] Compulsory purchase orders - para 15 - if any person aggrieved (a wider scope - anyone with an interest). In this case they suggest only the trial sponsor.

J - case where any person aggrieved cld challenge
Mr H - within 6 weeks and subject to that - no further challenge whatsoever. A timeline (TL)/
J - not much of a difference
MR H case Ostler - same clause Lord Denning [p135c of decn] c-f - Denning [missed]

Mr H - same points for other issues in this line - MHRA relies on ex parte Kent - didn't oust entorey - just a procedure to follow.

Thankyou @FarriersGirl This looks like one of those complex legalistic cases that are hard for us non-lawyers to follow.

Who is Henderson / Mr H? I can't find him on the list of participants.

From TT:

J finding reference.
Mr H - s 242 Town and Country Planning Act - similar wording re compulsory purchase.
[quotes] timeline - key point. helpful explanations - case Deutsch - OC re designated parking laws - same point - time limit applies.
para 13 & 16 - explanation at para 17 - similar ouster provisions in many statutes [quotes fast] - prescribed time and manner but otherwise court will be excluded.

J - scpe of category also procedural issue?
Mr H - ye MHRA - what's different ? Excludes a whole category of persons in way a procedural bar doesn't.
J - if arg were correct, eg paid for a trial, it would be unchallengeable.

Thank you @FarriersGirl for doing this, although I really hope there's one or two MNers who can translate this for a 10yr old to understand (me).

From TT:

Mr H - also squarely within constitutional principle on separation of powers. Ct decide what the legal parameters are.
Oceania 1753 and LA Albania 1821 para 31-36 - Cts and Tribs Regs. Oceania Very clear distinctions - nothing like wording in this case. LAA case was upheld - very limited circumscribed opp for challenge,

Mr H - LJ Glidewell case - one para comment - obiter - concession by Cs in that case. licensing decn challenge to MHRA. p580 - facts - and final decn letter - right to challenge under s 107.
p587 - they were successful as well as s107 Medicines Act 1968 , brought paralell JR.
P587 - the C's counsel asks for mop up orders for other sets of proceedings [4 in total].

From TT:

p588 - JR application dealt with under s107. [outlines the other proceedings]. p594 - LJ G dismisses the al apps on basis outsered as first case dropped out. That authority cannot bear the burden that MHRA seeks.

J - onto the grounds

AM - folowing services of Ds' summary grounds - concluded shd not pursue parts pf grd 3 (procedural challenge to Ethics Committee) remaining aspects and other grds are strngly arguable. Seek permission. regardless of the test yr Lordship decides to adopt.

From TT:

Requirement of some direct benefit (DB) , justifiable risk (JR) benefit (RB =) for individuals and [missed].
Old regs - Nov approvals core bundle 3 - stat scheme Reg 15 Ethics Committee opinion para 5 list of matters specif req to be considered and para 10. Reg 15 - para 5 list a-m - for the REc. equiv requirements apply to the MHRA. So - parts 2 & 4 sched 1 are reqd to be considered. Apply to all clinical trials (CT). Clinical trial directive CTD (missed). scientifically sound in all aspect. And in line with Declaration of Helsinki.
Before the trial is initiated - foreseeable risks for individ trail subjects (not as you go along)

From TT:

All CT.
Part 4 - additional safegards.
J- is plan that all of trial sibjects will receive the drug?
AM - all will receive drug - randomised to 2 cohorts. First immediately. 2nd after delay of a year.
J - will subjects now which cohort?
AM yes - not possible to be blind.
AM - all get the drugs.
J - Drugs are administered by injection? How many and how often?
AM - 6 monthly.

From TT:

AM - what happens at end of 2 year period.
Additional conditions Pt 4 applying to a minor. Consenting capacity 10 Direct benefit (DB) is to be obtained from the trial.

J - difference bw you abt what 10 means.
AM we say it means what it says.
J so do they. You don't agree what it says.
it doesn't mean some DB for every member of group, or majority. Enough for at least one
AM - a proportion.
AM Doesn't have to be a majority.
J we know weigh up risks to individ against benefits that might accrue. What is this actually adding?
AM req for their to be some indication from existing scientfic knowdge that there will be some b. Confident that some benefit for the group. An extra safeguard for children

From TT:

J - for adults you could have a trail that cld tell us something useful that cld be a peril, For children you need some B to the group.
AM Cld be 2 members - a small number. Depends on size of group - to group collectively. Important additional safeguard for children.

AM Wide public interest is permissible [for adults]
J - side effects -
RB Ok, but side effects for completely healthy adults Ok to continue.

J and other potential and future patiest [for adults]. Get a handle on what this al all abt.
See effect on healthy adults - can do that. You couldn't do that n healthy children. as no B for the group.

From TT:

J - Corollary - not aa cohort of health children - very distressing condition and it is anticipated some direct benefit for some.

AM - that's wrong. Significant risks that led to SoS banning them.
J from previous PX protocol

AM - example at para 32 - reference to hypothetical trial of weightloss drugs in children to illustrate what regs need to be convinced of. Not poss with certainty for an individual child - but need evid to believe that it will.

AM Para 10 - DB

J - Ds an Ip saying on state of evid and cohort selected, and care selecting them - there will be some DB.
AM - can't put it as high as that.
Were asked to include expectation of benefit to the individ.
J - they can't.
AM - reasonable prospect. DB criterion not directly addressed.

From TT:

AM - para 77 -of SoS skel. Seek to address our challenge - by ref to eligibiity criteria and reasonable prospect (RP)

J isn't RP a DB?
AM - watered down and insufficient for trial of minors - can't say expectation of benefit

J - if RP of B of a clinical improvement in manifestations of a distressing condition - conferring a DB on them?
AM No - a RP falls short of DB.

From TT:

AM - impossible for KCl to meet that criteria.

J - Dr Cass says evid gap.
AM - you have to have data that shows b may be conferred,. Evid gap can't sidestep protections for trials involving children.

AM - weight loss example - must be sufficient evid of b to group.
J I see.
AM How will such research be done. Data linkage study - follow those who recd these drugs. to see this effect. And studies on animals. WS Prof Evans.

From TT:

AM - principle 16 - more strict. interests of pt always prevails.
AM Helsinki Declaration - [which version.}
AM - compares definitions.

AM [missed re version of HD - not in place in Nov]. quotes this was operative.
JM says ot in 1996 version .
A bad point - MHRA own guidance and new regs..

Tweets have slowed right down - I wonder if this the sme problem as the DEFRA ET where we had a very long session and the length of it caused tech issues?

From TT:

[missed discussion on HD]

As an aside I can't C&P from TT this afternoon. If someone can take over that would be great. If not I can see Nick Wallis is live tweeting onto his GenderBlog. I will post a link to it. You don't have to subscribe or be on X to read it.