Court 1 Royal Courts of Justice – 28 July 2026 – Day 2 of 2
262 tweets
Good morning from Court 1 of the Royal Courts of Justice in London. We are awaiting the start of Day 2 of a hearing into the permissibility of a Judicial Review of the government’s puberty blocker trial. James Esses, pictured left, is one of the applicants. Live tweeting follows.
I am sitting next to @tribunaltweets who are also covering this hearing. So as well as reading our output you can judge us.
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Okay as per yesterday NOTHING I TWEET IS A DIRECT QUOTE UNLESS IT IS IN "DIRECT QUOTES". IT IS A SUMMARY AND CHARACTERISATION OF WHAT IS HAPPENING IN COURT.
Julian Milford KC (JM) is on his feet for the Health Secretary. He is continuing is argument from yesterday. If you want to read yesterday's tweets, start here:
x.com/nickwallis/status/2081674922837852178?s=20
Good morning and welcome to a sweltering Court 1 at the Royal Courts of Justice. We are here for the Puberty Blocker trial JR. The court is packed and there are campaigners outside. Live tweets follow.
Looks like there's going to be a lot of discussion on the Helsinki Declaration (HD) on clinical trials again.
en.wikipedia.org/wiki/Declaration_of_Helsinki
JM Principle 28 of HD is NOT one of the principles which apply to the regulatory framework when approval of the trial was given in Nov 2025. I have handed up to my lord the 1996 HD and in that version this principle and anything like it is not expressed.
[From memory principle 28 is that if the clinical trial is on a cohort of children there it must be of benefit to the group – or words to that effect – and the precise words were argued over for a good hour yesterday]
JM my learned friend (AM from the applicants)…
J what is the HD – it's not a treaty
JM no
J there is no presumption any legislation should be compatible with it
JM no. AM relied on HD 1964 being adopted – exactly what is meant by that is unclear, but the intention is…
… that regulations should refer to HD as guiding principles.
J does the guidance talk about HD "as amended"
JM no it just talks about the declaration, actually
[I think guidance in this case is UK regulatory guidance for clinical trials]
J I've got to say it's a rather unhelpful statement to say that reference to amendments have been removed as clinicians should refer to HD as guiding principles
JM yes
J and this point isn't relied upon with regard to to June 2026
JM no as that was about Destination Therapy
and safety (DT is what happens to the cohort of trialists when the trial is over).
JM we say the meaning of "likely to benefit" in HD 28 can't mean that every single member of the trial will benefit
J well more likely than not. The case I was thinking about was R v Bannerjee
which is all about the construction of "likely" in S12 of the HRA. And likely can mean more likely than not, or something less. That was a different context.
JM thos who signed up to the declaration are not looking it through the lens of an English court of common law
J they might well be looking at it through the lens of "direct benefit" in our regs – which is you shouldn't be doing clinical trials involving children where it is not anticipated that there could be a benefit
JM in the protocol it says a "reasonable prospect of benefit"
J right
JM on what HD28 means it is said to apply to persons incapable of giving pre-informed consent – vulnerable people. There must be a serious QM over how that applies to the children here, as the children
involved have to understand it and give consent, even though it's not legal consent. Do they actually qual for HD28 simply because they are under 16
J well is that right? Maybe a more natural reading of it is that it applies to all children and others who are…
incapable giving consent
JM that is one reading. Turning to Ground 4 [I think of the Applicants' case] which is that the MHRA irrationally approved a trial which will not yield meaningful data. This relies on unevidenced assertions
J is this the Carl Hopper argument – that you can't rely on something you can't falsify.
JM well that's their point, but that's not what this trial is about.
[JM takes J to a point in the core bundle that deals with this and asks J to read it. We don't get to see the CB]
J and is this linked to when you do a randomised control trial with placebos and so forth – that's more likely to prove or refute a hypothesis. this on the other
hand is a pragmatic trial where you are going to look at a cohort of people in treatment and see what the outcome is.
[JM nods]
J is there any other material in teh bundle that explains the diff between a pragmatic trial and…
JM I'm sure there is
J if those behind you could
give me the references.
JM the Applicants also say that the primary objective of the trial is not a measure of the short and medium term outcome isn't really accurate as they have widened it out to public health issues which stop it being a proper sci trial – we say there's
no inconsistency at all as it's perfectly normal to look at collateral benefits from undertaking it
J the test for a trial involving adults talks about benefits for participants for them "and others". But for children there must be a direct benefit to the group.
JM And when the MHRA looked this, they made their decision on that basis. But there's nothing wrong with looking at other benefits – whether or not other people might want to take these kind of interventions.
JM because this is a trial designed to look at mental health and equality of outcomes – are inevitably going to be different in every case. That's a diff thing from saying the trial itself does not have a coherent rationale. That's a red herring.
JM turning to Ground 5 – reasons. This is par242 to 243 which alleges MHRA failed to give adequate reasons for giving the trial the go ahead. There is no legal duty for the MHRA to do it, so it can't be argued. No stat duty for MHRA to give reasons for approving a clin trial
to the public. It has to give reasons for refusal in specific circs. That's when the MHRA or REC (ethical committee) if they refuse a trial must give the reasons to the trial sponsor.
the obvious purpose of that is to allow the trial sponsor to challenge the MHRA on why. This is a coherent legislative scheme. We accept that a common law duty to give reasons may arise…
but we do say the use of the common law to carry out that gap-filling exercise is where the case law is strong. [he goes to case law in the authorities bundle]
[CPRE Kent v Dover District Council – about council obligation to give reasons for decisions on planning]
JM "where the legal policy reasons are particularly strong". We say no such reasons duty arises on the mHRA
this is not a context where you have an incoherent and piecemeal development of case law. You've got a logical and coherent scheme for clin trials. The way in which the reasons duty is set out fits with the partial exemption ouster clause makes it part of a coherent scheme.
Thirdly MHRA's approval decisions are often commercially confidential and imposing a duty to give reasons for the public would be unreasonably damaging to the regulator and trial applicants
J common law could deal with that
JM it could do if all these factors pointed toward reasons being given
J and this explains why it's all set up in the way it is
JM yes
[JM goes to par 61 of Applicants skeleton]
JM where it says the need for transparency is threaded throughout regulations – none of the cited
texts say anything about the MHRA. They're about the REC and you will be addressed on that. Their points about something being publicly controversial and important is not a reasoned test. Which of the 5000 trials the MHRA considers every year would meet that test. It cannot know.
Oakley was a case about whether reasons should be given re permission of a football stadium on greenbelt land and the CoA agreed it should be under common law. That decision though was reached through a large number of factors – that the planning committee disagreed with
the planning officer's decision, it would affect the community, it was against local development plan rules etc etc. the most distinctive reason was that the officer had one view and the committee overruled him without giving reasons.
The type of things the Applicants now say were taken into account by CAN-SG and that was taken into account as evidenced by the pause in the trial and changes.
J doesn't that mean third parties should be given reasons. Shouldn't they have an entitlement to know why
JM well the decision was taken in Nov 2025, people complained and the regulator, being responsible considered them. They weren't part of the decision-making process.
J if this point is a good one, the relief granted by the court would be an explanation of the reaons.
JM yes
J because we now have 13,000 documents explaining it.
JM this is a pragmatic trial [gives references to where this term is explained in the bundle]
J so pragmatic trial is a term of art rather than a specific sub-species of a clinical trial
[solicitor who is also giving references agrees]
[JM has finished. Now Jenni Richards KC (JR) is on her feet for the Health Research Authority]
JR in terms of intro subs – although I'm going to focus on the REC's decision – when an application comes to it – it is a mere end point of the process – after a huge amount of work already undertaken, prior to the HRA submission to the REC
JR first was undertaken by Baroness Cass – and as we see from her witness statement (WS) she went back to first principles to examine the entire evidence base. She also says the design of the trial has been designed by ethicists, clinicians, regulators and scientific experts
it has undergone a significant and unusual amount of scrutiny.
J NHS commissioned Cass report because of Tavistock
JR yes
J Cass says there's an evidence gap and research should be done and so the Pathways trial was set up in respons to that. NHS appoints Prof Simonol and then
the two trial sponsors come on the scene
JR yes SLAM and KCL
J but you're looking at the bit before Prof Simonol (PF) was appointed.
JR yes [starts going through the process of trial's design and approval]
JR there was a "thorough and rigourous approval process"
J is it somewhere other than Prof McCauley's statement what the NIHR is, how it's constituted etc
JR if not we can ensure you get it. Prof Simonov (sorry PS)'s WS takes you through the trial design process
working with a very experienced group of clinicials, and advisory board and clinicians within gender services – this trial is the end product of a very comprehensive piece of work, both internally and with external scrutiny.
When the MHRA receives the trial proposal it then goes through more scrutiny from the MHRA and REC and other bodies if the MHRA thinks it appropriate. [takes J to Dr Cave's WS from MHRA]
Building on that, the REC is not expected to duplicate MHRA – it can take assurance from the MHRA.
In the REC policy document, REC focuses on ethics, not expected to undertake detailed review eg qual of science of proposed research as this is for the sponsor reviewed by relevant experts. Where others have a regulatory responsibility, REC can rely on them to fill it.
eg the MHRA has the primary legal responsibility for the safety of the research it regulates.
The MHRA has responsibility for safety of trials. The ethics committee can rely on MHRA who can share their own safety reasoning with the REC. The REC should look at info about risks and benefits provided.
JR re the REC itself. It is a volunteer committee. Not employed by MHRA who come together periodically. Mix of experts and lay members. Expertise not in specific scientific field.
J and that's because their function is not actually a technical one?
JR exactly
JR applicants have now dropped their objection to the insufficiency of lay members in the REC.
It's in that context that REC members are not experts in the conventional sense, but they have their own expertise brought to bear on what they must consider.
Mrs Justice Farby has addressed this in past [goes to authorities bundle]
The arg for C's in that case was that the CQC inspectors are not experts in the relevant field, but it was decided that their own professional experience had relevance.
J there's a reason why judges are cautious when dealing with matters in which people don't have technical
expertise – we have to see that they fulfil their function which is seeing that a matter is proper, rational and lawful. But this is a slightly different case. Parliament decided ethical qs was better decided by people from all different backgrounds, rather than, say, a judge
JR yes
J that's not to say if they go beyond their legal function a judge can't step in and say so
JR yes. let's look at the stat function the REC is fulfilling…
JR the purpose of REC review process is not to conduct a public consultation, nor adjudicated between competing application – it must be an independent ethical assessment of the application
itself. The application is made by the chief investigator. Who must supply specific documents to the REC. App docs include – partics relating trial design… skipping on… arrangement for recruitment, details on inclusion and exclusion of patients..
assessment of ethical issues relating to trial risks, potential benefits and aims. Trial protocol itself, letters to potential participants, material given to participants, material to record informed consent…
The essential function of the REC is to give an opinoin on the clin trial to which the application relates, to ask the app for further info. The REC should give an opinion on any other issue relating to the trial IF ASKED by the applicant.
Trial app can also appeal a REC decision.
J that's equiv to MHRA, there's no equiv ouster
JR there's no ouster, no. what there is through the regs is a stat relationship between the app and the REC and the function of the REC is to adjudicate on the docs.
JR re the Nov 2025 and June 2026 decision. AM is right to say…
J is this working up to a submission that where you have a detailed stat regime before an app goes before the REC and then the REC can do things, we don't then import some wider function from third parties
JR yes. We should view REC's decision making in Nov and June together. The Nov one does not fall away.
J that was the big point?
JR yes
J that was much shorter than the others
JR yes
[JR now taking J to some more relevant authorities – listing them, mainly]
J once it's approved ethically, it's approved and that is that
JR yes
J what if matters unfold in an unexpected way – that will be considered by the MHRA, not the REC
JR yes – there are multiple examples of ongoing oversight. Those running the trial must ensure it is running…
… properly. The MHRA has legal responsibility and can exercise powers over it.
J what about the National Multidisciplinary Team (NMDT) – this hasn't been mentioned. What does the NMDT have to decide
JR the trial protocol sets out the role of the NMDT, but in relation to risk and benefits – no child will take part in the trial unless the clinicians and the gender clinic approve, there is consent from child and parent and then it will go forward to the NMDT who have to approve
JR within the REC's knowledge there is the role of NMDT, there is oversight and scrutiny I have referred to. It's not just left to KCL and SLAM, there's a steering committee appointed by NIHR and there is further scrutiny through the data monitoring and ethics committee, which
has a number of independent members. Lots of independent ongoing safeguards. With relation to the permission threshold, that will be addressed, but C's submission that the sheer vol of material suggests that the complexity of the matter suggests permission for the JR
should be granted is not supported by [case law where a judge said "never mind the quality feel the width" is never a reason for granting a JR]
JR in relation to standing [D's argue James Esses and Keira Bell have no standing in this case]
[lists authorities and references she wants J to look at to support her case "a personal interest does not equate to a sufficient interest". also cites Good Law Project ruling "strong and sincere interest does not equate to standing"]
JR now turning to grounds of challenge – complaint 4 relates to Nov 2025 decision saying there was an invalid delegation in autumn 2025 leading to the Nov decision.
[tell J where to find Standard Operating Procedure SOP]
That not only makes clear full committee can delegate to subcommittee, it says it is the norm. C's complaint derives from the minutes of full committee meeting in Sep 2025
which contains a typo. It says it delegates decision to the full committee, which it can't do. We have a statement which confirms it was a typo and explains decision. The chair of full committee has told us they decided to delegate to subcommittee, decided who would be on the sc
and that was in fact who did sit on the committee.
That should put your mind at rest as to it being a typo. Even if this were a procedural irregularity, which it isn't, that is still not a reason to stop the trial – we have to look at proportionality.
Re transparency – C's complain of a lack of transparency. Headline response – reg 15.9 of the old regs governing the Nov 2025 decision requires REC to publish a summary of its decision. That was done. Entire minutes have been published. New regs
re substantial modification require trial sponsors to be informed, but only summary. There are new transparency requirements which apply to the sponsor – reg 27.b has a power conferred on the HRA to publish info to the public, but no duty.
At its height this empowers, but does not require the HRA to make accessible not the docs, but the info in it. There is also a requirement to consult before making any info public. The HRA has already published in Dec and Jan a vast amount of material relating to the Nov decision
Insofar as the june decision was concerned. That dec was finalised on 18 June. As things stand as between 18 June and now, the MHRA has not published on its website materials relating to the substantial modification. It has every intention of doing so.
J If the late publication was issue, the remedy would be an order to publish the material.
JR yes. it's nothing to do with the lawfulness of the process. There is no timescale which the HRA has to publish any material
In May a full REC decided to ask for limited info from KCL and delegated its decision to deal with the KCL response to a subcommittee. C's say there was no power to do that under new regs. That's not true [or as JR said "unarguable" – but I think in a legal context means…
"can't be made as a point" rather than "such a good point an argument would be fatuous"]
JR reg 9.3 empowers delegation of ANY of its functions.
J and a subcommittee can be two people?
JR yes. It can be one person, in fact
[takes J to the rules]
JR [basically] there's nothing procedurally wrong with the way the REC and MHRA went about their decision-making. Moving on.
JR it's lawful for a ministerial decision to be reached informed by officials in a department with sufficient regard to the information that they process. So it's fine for the REC to make decisions only based on material that MHRA have decided to put forward to the REC.
JR in the present case I told you about the REC's stat function – the REC is not statutorily mandated to consider 3rd party complaints, but it adopted a structured approach, as can be seen in the HSM WS. Their priority was to preserve independence and impartiality of the REC
Insofar as the CAN-SG corr is concerned. as we can see from the HSM WS, there's a v long section headed specific 3rd party corr which sets out exactly how it was dealt with.
J who are CAN-SG?
JR group of clinicians
J who have concerns about the trial
JR calls itself the Clinical Advisory Network on Sex and Gender, and I think Dr Irvine is part of it and you have a WS from her. It's not a stat body.
J no but it is a group of clinicians.
JR yes
JR there is a substantial body of corr between HRA and CAN-SG in supplemental bundle. When we get to the MHRA's scientific dialogue, which doesn't involve the REC at all, it's clear to the HRA that some of the matters being raised by CAN-SG are effectively being looked at by the
MHRA. You will see from HSM that for pragmatic reasons relating to timing that some of the CAN-SG would be shared with the REC. So there is a careful evaluation of what needs to go before the REC by the HRA. C's ask you to look at diff of approach between HRA and MHRA.
Neither approach was unlawful. In relation to Prof Curtis (PC) the HSM manager raised qs about follow-up period. This was the sort of thing the REC would look at. The HSM manager raised the matter with REC and in March this year for pragmatic reasons a decision was
taken to share material with the REC. C's complain when HRA do share material with REC and complain when we don't.
The letter from KCL re the substantial modification application. This is from PS which answers concerns raised by the MHRA and the HRA and you will see a heading "3rd party complaints" – the matters in italics were what HRA was sharing with KCL and you can see the response from
KCL [making the point that 3rd party concerns were raised, HRA took them seriously and shared them with REC and KCL and sought responses from KCL and got them]
REC was told KCL was responding to 3rd party concerns. REC decision in May – the REC considered them and committee agreed app had provided adequate response to issues raised by third parties.
This is a rather long way of saying that these matters did not have to go to the REC, but for pragmatic reasons, they did, they also went to KCL who provided responses which the REC considered. The fact Cs are not happy with outcome doesn't mean they weren't taken seriously.
J on direct benefit. Do you say DB can include the benefit of having a reasonable prospect of helping. Does that have to be the case for every member of the group
JR yes. every child participating will meet the reasonable prospect of benefiting
J because that's the protocol
J is that a stat requirement
JR no
J because that way you couldn't have a placebo trial
JR yes
C's say HRA failed to consider 3rd matters "properly or at all". Then in skele they say "properly or adequately". The use of adequately reveals the C's real case is about the weight attached to these matters, not an absence of consideration at all.
J right
JR there is no reasons to think an experienced REC would not consider the matters before them and take into account their stat responsibilities. This was an experience and recognised REC with experience of trials involving minors
They had awareness of HD and good clin practice. Re direct benefit criterion, PS in her statement explains the concept of DB is a long-standing regulatory requirement. The REC had the trial protocol where all these matters were set out.
The REC had inclusion criteria. Which notes reasonable prospect of benefit, but all the other criteria [before a child can be accepted onto the trial] have to be fulfilled too.
Can be achieved in qual of life parameters, mental well-being, improvement at school etc
J AM's point was about misconstruction of the text. Saying it might benefit was not enough.
JR that's wrong – otherwise you'd never get clin trials involving children. There are always
inherent uncertainties. If you don't have that you can't justify a trial. if you already know, you don't have a trial. J you have two cohorts in this trial. One who starts on PBs immediately and one starting a year later. If it was already clear the trial was likely to confer
benefits, it would be unethical to delay the second cohort.
JR quite possibly. and the individuals in question have been through a process whereby they haven't been able to alleviate what might be quite severe mental distress.
JR these were all matters before the REC. Saying the REC failed to consider the risk/benefit. JM has already told you about the evidence from KCL which we endorse and agree with.
J is there a statement in any WS about addressing this subject?
JR best look at REC minutes
from Sep and May. When you look at the REC mins we see a series of Qs and As most of which go to risks and benefits. eg numbers of participants, blocking normal biological processes of puberty
J these aren't about benefits
JR no they are explanation of risk and potential disbenefits
J where are the benefits
[takes him to another set of minutes – where benefits are said to exist]
J that says benefits were considered
[implication being doesn't say what they are]
[JR takes him to the WS which describes in more detail what the REC did discuss]
JR this needs to be looked at in the round whereby risk/benefit is considered throughout.
JR complaint re failure to consider animal studies
JR the evidence gaps were highlighted by Cass. The existing state of data and inadequacies in it was why REC was considering this app.
Nothing in the regs requires REC to consider other studies. In terms of the data linkage study, that doesn't cover what this trial is trying to achieve.
The REC was aware of the gap in data. C's complaint is that REC should have considered an animal study or the data-linkage study. That's not the REC's role.
J C are not saying that this PB trial shouldn't ever take place, what tehy are saying is that there is unexamined evidence which had it been examined might or might not have provided the evidental basis for saying the test
was met, and having not looked at that material, their claim says you didn't look at this material, there was that material out there and it might have told you if the benefit test was met.
JR it's not the REC's role to look at the benefit to science.
J I think you're entitled to say – it wasn't just something that was thought up by KCL and SLAM. It was
commissioned by NHS to plug the gap ID'd by Baroness Cass. She said research is needed. NHS commissioned it then KCL and SLAP, and REC's function in that background was to look at what was put forward for the
study.
JR yes. you have evidence before you which explains why neither data-linkage or animal studies will fill that gap
J essentially that data-linkage study is too late. These
are people who had things happen to them in the past but several things have happened since.
JR but also people who receieved treatment pathways criticised by Cass.
J But we are looking at people who might never be eligible for this trial. And the animal study?
JR that's dealt with by Cass
JR animal studies happen when drugs have not yet been used on humans. PBs have been used on humans for years. The animal testing phase for PBs has long since passed.
J there are some quite complext psycho-social effects of gender incongruence and what you're trying to work out
is how are you going to test that on animals
JR precisely so. and so there's nothing unlawful about not considering it.
[we move on]
JR C's complain about REC not approaching the MAF issues in the way they want it approach. Locked in is a false premise. It's asserted by C, but previously available data is about what was happening at the Tavistock and assumptions from that should not be applied
to current gender services. Cass makes the same point in her WS. As does DrnAsuud and Prof McCauley.
The q about MAF was extensively covered in the KCL covering letter in response to qs from HRA.
It was made clear and was going to be made clear to participants that MAF was outside this trial and no guarantee they would proceed to MAF and that was set out to the REC. The REC took the same position as the MHRA and CHM [don't know who this is] and CHM took the decision
that this was not a reason for the trial not to proceed. "So this is disagreement dress up as a legal challenge". The REC looked at it in the light of agreement between MHRA, CHM and HRA.
JR re irrationality – when one looks at what this submission amounts to is that MHRA, Cass, NHS, CHM, REC, HRA are all wrong
J they don't have to say that. They just have to say that the REC acted irrationally
JR it's not clear to me what's left beyond a merits-based disagreement.
J is this what some people call outcome irrationality
JR yes, rather than process irrationality
JR pleading is that this process lacked the correct protocols for a proper clinical trial [in Nov] and then in June it's a failure for the MHRA and REC to consider the locked in issue. Which is a hopeless point.
JR what needed to be made clear to participants was that MAF was not guaranteed, nor is it ever closed off.
J you've got the NIHR's statement it wouldn't fail for lack of funding.
[we've just had lunch]
[Court has reconvened. JR is still on her feet]
JR whether common law has duty to give reasons it shaped by stat framework. I say that stat framework is inconsistent with what Cs contend. There is a limited requirement to give reasons to trial sponsors
JR also Parly has given thought to public interest. both old and new regulations require publication of a conclusion [on a trial going ahead] whether favourable or unfavourable
JR HRA has power to make info avail to public. So specific reasons to applicant, publication of summary and general power in HRA to publish matters as it sees fit – this is inconsistent with a duty to give additional reasons.
There is a vast amount of material which makes clear the decision making processes. It would be futile to expect anything more now.
Re 3rd party comms – KCL wrote to Prof Curtis (PC) and CAN-SG with extensive details setting out everything in considerable detail
Those 3rd parties therefore knew what HRA's position was. The suggestion there is a duty on HRA to do more is wrong.
J thank you. Mr Sharland?
[Andrew Sharland KC (AS) for KCL is on his feet. Says he's been allocated 90m but won;t need it]
AS in relation to our evidence on
interim relief – we have not filed expert evidence, our evidence on interim relief comes from people involved in the Pathway trial – who have detailed knowledge of the trial and the cohort. They have no vested interest in the outcome of the trial – they are not coming at this
from any particular ideological viewpoint. We could not get independent witness evidence as the vast majority of avail experts have actually been involved in the trial in some way.
AS now going to factual points which I hope address q's you have raised…
J is the lack of independence – is that not going to admissibility rather than weight?
[there is a discussion about this which is going over my head]
AS where the Pathways trial is up to. KCL gave an undertaking not to commence randomisation nor provision of PBs before 1 Aug 2026. Listening to your qs yesterday one might have thought you assumed all the blood test, x-rays, investigation of what tanner stage participants are
at
J say that again
AS referral to NDMT – blood test, x-rays, scans, tanner stage (stage of puberty) an intrusive test. They have not been done. It's not appropriate to carry out tests if we don't know something is going to happen. Partic x-rays – you can't x-ray children
with out good reason. And from a psycho-social perspective we don't want to raise hopes if the trial isn't going to happn
Secondly – these tests only have a short shelf life – so a tanner stage inv is not going to be valid in 2 months.
J what does NMDT referral involve?
AS I'll get to that
J if you have a process which requires a NMDT and you're asking this team to validate a decision that proceeding with a PB trial would be in the child's interest. It might be said that if there is some uncertainty
over the trial happening – it would be better for clinicians to work out the effect on the child – not for me.
AS yes that is a clinical call not a legal one and there may be individuals better able to deal with uncertainty than others
J the NMDT looks at each ind trial partic one by one
AS each potential one
J yes
AS yes. the number of young people about to enter into the trial. AM said the evidence was inconsistent. In Dr Kinden's WS she refers to 2 or 3 cases going in in Aug 2026 with a further 13 or 14
going in shortly after.
That is a low proportion of people in gender services. I think 1500 children have been referred to the NHS. Aiming to put around 5% through. The basis of that 5% is from other conservative models inc in Scandanavia
These 17 young people on the cusp of going to NMDT – 12 from NW 4 from SW and 1 person from London
J how do you get to 226
AS that's the total trial cohort – you may be assuming half cohort gets it on one day and other half a year later. The trial process takes 3.5 years
J so the two year period is rolling and so over the 3.5 years the trial is open there is a rolling period of recruitment.
AS one further clarification – it's being explained to you re randomisation. The cohort who get it now get it for 2 years. The cohort who get it now, get it
for 12 months.
AS so yes 17 young people are considered likely to be eligible in the next few months. There is a risk to those 17 as they are older and there is a risk of aging out. They've been on the waiting list a while. Tavistock was closed down, but that didn't solve
the problem. The older cohort who have been waiting for treatment are at the forefront of the list and they are in danger of aging out in the next few months.
AS there was a q raised about whether a new stat instrument would need to be laid for an extension to the study
it wouldn't. It would be within the regs [open extension is presumably giving the cohort CSH?]
J if MAF hormones are banned would that need something
AS one has to assume there would be a carve out for those on the trial
AS re the NMDT – the genesis of the NMDT is rec 9 of Cass report. it is to provide an opinion on the appropriateness of treatment. It's independent. It's unique in the NHS. It makes recommendations on PBs and MAF
To put it bluntly – part of the prob with tavistock/GIDS was inappropriate prescriptions of hormones and NMDT is here to protect against that
J was this clinicians who didn't have the nec specialism to prescribe
AS what is coming is so diff to the Tavistock (T) in so many ways.
AS [refers to bundle data on what NMDT is and what Dr Absud has to say about it.
AS re NIHR – what is it. They say they are funded by Dep of Health to improve health of the nation through research (reads from website) – work is directed by chief scientific advisor at Dep of
Health who is chair of NIHR. Largest funder of clinical research in the UK.
J when it comes to various uncertainties in the future a feature of this case is that there's been a few inferences drawn from disparate assurances by diff groups.
Is your point that these groups are not independent from each other? NIHR, NHS England are both under control of Dep of Health (DHSC) so on the face of it although they are diff orgs they're not completely
AS they are working together under joined up govt as they should.
AS turning to threshold permission in this case. [goes to Mass Energy judgment]
J there is a CoA judgment – Plan B Earth which sets out one test
AS Mass Energy is CoA too
J let's have a look then
AS this was a planning case
[asks J to read pars in the judgment]
[J does so]
AS now to turn to Plan B which you have loose
J I do
[asks J to read pars]
AS Plan B was heard over 7 days in a rolled up hearing and the CoA was told it should apply a higher threshold and CoA disagreed in that case
AS key words are about it being in that case. So higher threshold does not apply in a rolled up hearing. Today is not a rolled up hearing – today is two days on permission and interim relief
J if it was a rolled up hearing why did the q of permission arise at all?
AS I am equally mystified.
[J is looking through the judgment]
J is that right? Originally 5 claims… [starts reading judgment out loud]
J it does look as if the claims were the ones started at the rolled up hearing
AS I suppose the only difference it makes is if permission is refused you've got less time to go to the CoA, but it was being run in the CoA.
AS but higher threshold does apply to this case. This is a matter of considerable public interest – there is urgency. There has been a lot of delay there have been a lot of problems caused by the delay
You've had hearings and evidence.
J the latter point is key. Normally you don't get this much evidence.
AS yes.
J quantity of WS is much larger than you'd have in a JR
AS yes and we're having a two day permission hearing when normally you get one
AS so what is the point in having a two day permission hearing if we're going to have a two day hearing several months later. You\ve got all the evidence. What is the point in coming back and doing all this again?
AS this is the 7th hearing which you have sat for. You've hit the ground running on this. there simply isn't any point in granting permish on the arguability threshold – it should be a far higher threshold.
AS now – app for interim relief. [asks J to look at C's skele – pars 71 and 72]. Here they set out what they say is the applicable law – let's go to that.
The 3rd claimant is the BSG – no evidence any of their children will be on the trial.
J they're not relying on any harm to them. Its unusual – Cs are seeking interim relief to protect the trial participants who don't want to be protected
There is some authority which allows for this.
AS you say it's highly unusual. I say it's unique. We can't find any case law in which C's have sought to claim relief for a party which doesn't want that protection. It's unprecedented and court should be v v wary.
It is essential for the trial that the young person must want the intervention and their consent is informed. There is a lengthy process. There must be permis from parent. Clinicians also and NMDT. So you have all these people bodies saying this is appropriate, necessary
and on the other hand you have a group saying we think this should happen and we know better than you, your parents and the doctors and those there to protect you.
I'm not saying you don't have jurisdiction.
There is a decision to be made.
J only one parent has to agree right
AS yes
J so what is the process if there is a dispute between parents
AS they can go to the family court
AS before any order made to stop the trial there would have a decision made that the parents and doctors were not acting in the best interests of the trial. Further you would need evidence that Cs have the necessary expertise
J doesn't that go to standing?
J once they're in on that they're in.
AS you have to have a good case that these Cs have the right to protect people from themselves.
AS it's been pointed out to me that views of both patients are considered in the NMDT process and are taken into account. So you only need one
parent to consent, but disagreements are taken into consideration and you have the family court as a safeguard.
AS if the Lord makes an order for the interim relief sought it would interfere profoundly with the cohort and their parents' Art 8 rights. Something similar rose in the Transactual case where there was an argument that the PB ban interfered with Art 8 rights
but the court decided it was proportionate.
J the putative trial participants are not interested parties. On a strict reading of the rules maybe they should have been, but that might have been a silly idea. If any of them felt very strongly about it they could have joined the case.
AS still doesn't mean they don't have Art 8 rights and you would have to engage in an analysis of Art 8 before making any order.
AS returning to the C – they cite the RRR CoA judgment where the court talks about the importance of the protection of public health. They say it's in their favour, but we say its in our favour. is it a group that doesn't accept gender incongruence as a real thing?
AS the purpose of this trial and all its safeguards is to stop situations happening like Keira Bell. It's not the C who is able to determine what is in the interest of public health.
AS you asked for more info about Professor Dahlgren – we have a letter rather than a sworn WS
AS those are my subs
Fiona Scolding KC (FS) on her feet for SLAM
FS I adopt all the subs of the Ds
FS as to the issue of the jurisdiction to make an injunction – I have not found any case where a 3rd party who would not be affected by an injunction have got an injunction against an action to protect a third party who don't want that protection
FS we also asked a therapist to ask some parents of children attending gender treatment clinics and as AM identified that some parents thought their child was not appropriate for the PB trial – this is the system working as it should
J these were not candidates for the trial
FS correct. There are no formal candidates for the trial till cleared by NMDT.
FS but they are indicative of the discussions that would be had before candidates are id'd
FS Cs are asking you to second guess clinical judgment, which you can do, but in Bell v Tavistock the CoA were not there to go behind clinical decision-making
[sorry the CoA said it was not there to go behind etc etc]
FS this case is diff, and I'm not saying you don't have jurisdiction, but particular care is needed.
J is there a par which addresses this directly
[FS gives some pointers]
FS the last point I make – "delay comes with a sig risk in this case". This isn't just about a 4 month delay. A number have been waiting 3 or 4 years. The average age of the likely candidates is around 15. Soon they will become ineligible because they will start puberty.
Prof S makes this point in her WS. These are young people who have already waited a v long time. "If they do not get these drugs it is the end of the road from them" the opportunity to intervene at the right moment cannot be missed.
These people are distressed about the development of secondary sexual characteristics and so if they arrive it could cause harm contrary to C claims.
Time, social relationships, transition at school could all be affected. Parent 1 says "my child has put their life on hold"
They are not leaving the house, they are not socialising they are not going to school, because of the scale of their gender distress.
Delay therefore is not harm-neutral.
re the possible health problems from taking a short dose of PBs Prof Bannerjee – he disagrees with Prof Dahlgren's analysis.
J he hasn't put in an expert report – is he independent
FS can't answer that definitively
FS likely but don't know for sure. Could find that info out.
J the point AS was making was that if you insisted on somebody who was not part of a gender service to opine you would rule out anyone who could opine on this topic in the UK
FS can't say that for sure, but it's quite a small area. Everyone who has any expertise is involved in one way or another.
We know that 20% of young people being seen by the NHS gender service are already sourcing PBs and CSH themselves (not including those who don't…
… reach the first appointment). That means there are a larg numver of young people taking "vast quantities" of these drugs doing significant harm to themselves, getting them online and using them off-label.
By granting an injunction you would be pushing children away from a route of protected, wraparound care, "into a world of unregulated half-baked misinformation" and serious outcomes.
J what about the harm of the trial starting and then it having to stop due to a legal ruling. How would clinicians be involved in this?
FS in every individual case – one of the reasons none have gone to MNDT mean that clinicians know it's not fair to try to randomise children
unless there is more certainty. We are dealing with people who have a background in managing paediatric services. This group of children have complex mental and physical health conditions. They would not be put forward without certainty.
FS sits down
Aidan McCullough KC (AM) back on his feet for the C to answer the last day of advocacy.
AM the test for permish – we accept there has been the oppo for more scrutiny, but it's not remotely comparable to the level of detailed argument C could advance at a full hearing
and that's due to compressed timetable. Summary grounds for D only came through ten days before the hearing and whilst this has been a two day hearing – it is nothing close to what would get heard in a full four day hearing.
Yes th court has the vast bulk of documentary evidence required. It's not comparable to a hearing and cannot be viewed as a proxy. Dr Cave's 2500 page submission did not appear before the deadline.
Your experience of this case should not be used to raise the bar to a full hearing. You've got 13,000 pages of docs to go through which you haven't gone through.
We submit the test remains the familiar test of arguability
J the case has to be arguable with a realistic prospect of success
AM yes and we wouldn't dissent from that
AM on the issue of the ouster – that [case law] decision was made on an express concession by the C that the JR was ousted. That was a tactical decision to ride the other horse.
In the light of my learned friends' submissions – the PB trial is to determine the benefits and risks of PBs. They cannot say if there will be any benefit. The current state of knowledge is that nobody knows if PBs have any benefit on gender incongruence. The trial is being
proposed to find out and what the risk of taking them may be. This is fundamental when one goes to the direct benefit issue. To return to HD – it is uncontroversial that the HD Principles are applicable to all crim trials. They inform the approach to the conditions and its
the conditions that the D focus on. JM's suggestion that for the purposes of the C the HD is frozen in 1964 is inconsistent with the MHRA's statement that clin trials refer to original declaration and all iterations thereafter.
J yes but which principles are therefore applicable
AM I think the best one to say is the current ones which avoids the difficulty of referring to a particular version of the HD
J odd the draughtsman didn't say "as amended from time to time"
AM yes, but I don't think…
… that anyone meant going back to the 1964 version
J it would be slightly odd if that's what people were being required to do – ignore subsequent amendments. What is this informing
AM that unless the benefits are clear the risks must be minimal
J is the reasonable prospect
of a benefit a benefit?
AM not sure it helps with that. Re the issue of clinical trials on minors being addressed. The express requirement that there should be direct benefit "is to be obtained from the trial" – the benefit is for the group, not the ind, which is addressed
separately. you don't have to – in order to meet the condition – you don't have to predict what part of the group will get the benefit – which takes in placebos. The benefit of the group can be derived without demonstrating it will benefit ALL the group
A expected benefit could be part of that formulation
J meaning more likely than not
AM and reflecting on your lordship's q – would it be one person – we think not, but how many benefit? It would have to be significant, but maybe a significant minority.
J and not a reasonable prospect for everyone
AM no unless it was possible to say that on the balance of probabilities for the group.
J so in the example I gave yesterday of the cancer drug which stands a reasonable chance of curing an individual – you can't do that
AM you can because you're expecting the group as a whole to benefit. The direct benefit can be – say you have a clin trial with a 25% chance of curing cancer and you have a cohort of children. On that hypothesis, there is a benefit to the group – don't need it to be 50%
but there is expected to be a benefit to the group as a whole. It's been contended you could never have trials involving children as subjects on our construction, but that's based on a misunderstanding
AM the purpose of this is to exclude the benefits that would otherwise apply – the focus has to be on the benefit to the group – not to some future or wider cohort – it has to be direct. It "is" to be obtained. Not hopefully, not plausibly… you have to have expectation of
direct benefit to a group of children. That is a key safeguard and that's why it's there and that's why in our submission cannot meet the threshold, no matter the scientific interest nor the information it might yield.
The position in relation to KCL's inability to indicate direct benefit, and the patient leaflet which tells participants there's no promise the trial will help at all.
Prof Simonov addresses direct benefit doesn't because she can't go further than say the cohort "will include" those who "may well" benefit.
It cannot be shown there is the necessary direct benefit to the group.
Similarly, in the KCL FAQ for it says risks are v uncertain and we are at clin equipose on this point and we may well find the case for hormones is helpful or unhelpful. So when you were taken to the mins of the May REC meeting…
… in the penultimate par, when your lordship asked where the benefits are addressed. The terms in which the REC concluded there was "potential" for direct benefits is not enough to meet the statutory regs. So there's no
secret and "KCL have been entirely candid about the inability to assert an expected benefit for the group and as such in our submission the PB trial cannot meet that essential condition and both regulators were wrong insofar as it was considered in concluding that it did"
It was not addressed in the Sep REC and it was ahead of the June decision but in a way that doesn't meet the threshold.
J REC thinks there is a direct benefit
AM no a potential
J they think that potential is a direct benefit
AM I may be over-interpreting their minutes, they say potential for direct benefit, which is in line with what KCL say – "maybe they will benefit". That's the highest they can put it.
I didn't address validation of data, but it has been addressed by my learned friends – there's a key point in this submission
J sorry – what is this
[AM takes J to bundle]
AM it is a condition that the clin trial is nec to validate data obtained from sources in A or B
It's not enough to say we've considered doing linkage studies and then didn't. We considered animal studies and didn't
J you've either got it or you haven't
AM it's obviously the protection it provides – you're not acting in a vacuum. You have to have underlying data
Even if linkage study or animals is impossible, you still need data from somewhere. This has been misunderstood by D and IPs in coming up with lines on linkage study by saying "well they're too late" – which we don't accept – as we could ask them about regret and see how they are
Either way – you need to have underlying data for the study to validate. And they don't have that.
On animal studies – there is scope for them, but that is a secondary question on whether there is underlying data for this trial to validate. And that has not been identified.
So with respect to the HRA's subs, the point is misunderstood – the regulatory scheme requires what is set out
J it's a vires point isn't – are you saying its a statutory mandatory consideration
AM yes
J it's a test
and if you can't satisfy it you can't authorise it. It's not just something you just consider.
AM that might be a better way of putting it. You'd heard how much the trial has been considered and I accept it has been very heavily scrutinised, but it doesn't meet the lawful trial
conditions on minors.
The reasons challenge. It's nec to appreciate that in relation to the MHRA there was no info at all about the decision making of the MHRA. One can see the struck through part which meant that as originally issued the Cs were flying entirely blind against
the MHRA and making a complaint about that and raising the prospect of an application for specific disclosure. JM referred to the Dover and Oakley cases which we rely on. There is an argument in this case for the MHRA to indicate the basis on which they had approved
the trial and pointing to the ouster clause and the limited extent to which there is a stat duty to provide info.
J even if that's right, we've got the reasons now
AM we recognise that – the only remedy we seek as that there is a declaration – that would not be a sterile
action for the future.
J you don't get substantive relief to stop the trial – might be of use in other cases
AM my lord I accept that – it's not a showstopper as it were. CAN-SG even without the benefit of reasons, put forward an unfocused objection to the approval, which led
to a significant intervention. It would be far more reasonable if they got the reasons and could make a focused response. Even unfocused there was a modification – albeit one which still led to the trial's approval. But it show how important it could be.
Re our complaints about REC – we have already abandoned 1 – 3 and having heard Ms Richard's subs, we now don't pursue 4 and 6. This I accept is unusual in a live hearing
J well I've already got quite a lot of areas still in dispute so any reduction is welcome
AM as my lord can appreciate the time for mature reflection has been limited. But we maintain complaint 5. The summary of the REC meeting published was far shorter than the minutes and the subsequent publication of the minutes does not really satisfy
The summary was "further information: favourable opinion". It was only when this legal action had begun that the minutes were published.
The significant material that was not before the decision-makers that was supplied by Dr Irvine from CAN-SG and Prof Curtis. We accept the proposition that it is permissible for the official to make a primary judgment to decide what goes before the REC
But ground 2 is on the basis that HSM could not rationally have withheld it from the REC. We know the inconsistency in the HRA's position that it wasn't so obviously material, whereas HSM says it wasn't put before the REC as its substance had already been considered.
If you are an official and you are being asked – here is a sub from a third party – should I put it before the committee. and if the consideration is that the subject matter is already front and centre to the committee you might take the view that it isn't needed.
Health officials are not nec using words in the precise way that we as lawyers do. The CAN-SG submission was not even considered prior to the Sep/Nov 2025 decision. But when it was the trial was modified.
On irrationality – we do maintain the challenge in relation to the rationality of the scientific proposal in the context of the conditions needed to be met and the protocol does not meet them.
Re Prof Dahlgren – AS resumed his attack on her – saying she lacked clinical experience in relation to gender dysphoria and her work was ridiculed. We see that Prof Bannerjee doesn't himself treat gender incongruent children. He has an involvement in the trial, but says himself
he's only got experience in giving PBs.
J not really sure we're going to get far if we start slagging off each others experts. I just think that a bigger point is the more principled q about whether the function of the court granting an injunction stopping
people from getting a treatment they want.
AM the function of a court is balancing harms. and if the C has standing they can ask for interim relief. they have put forward expert evidence. The only expert evidence. No expert evidence on the other side in the form of WS and opinion
There's no knockout blow on either side.
J other parties aren't saying you can't raise them. they're just saying it is unprecedented and court must have caution.
AM it is unprecedented. and an issue of principle
AM you've seen both the expert reports for a ruling on admissibility. In one, the issue of children accessing unregulated drugs is addressed. the extent to which it is accepted and the extent to which it arises during a delay.
That reflects the basis of the submission that I made whether the risks to those who stood a real chance of being admitted to the trial would seek to access unregulated drugs.
[ie sorry – he's saying that they are not likely to be a cohort who does]
It was suggested that Bell v T made it in some way inappropriate to grant relief having turned over the divisional court which was attempting to set down some rules.
I am reminded of one of JM's pleading points. He suggested that by ref to our SFG par 241 that in relation to the MHRA's acceptance of the sponsor's response for the grounds of non-acceptance and said that wasn't possible according to Dr Cave's statement…
J are you saying they have sidestepped the q and not given an answer to that
AM essentially yes. The clock has struck 4.32pm – I am grateful for your indulgence.
JR gets on her feet to give a reference to the judge – re data we are seeking to build upon – says it is addressed
in various skeleton args
J judgement will be at 2pm on Friday hopefully with a written doc I can hand down at that time. Prob won't circ in advance. If it does it'll be on friday morning. There are a range of possibilities
1. interim relief allowed and permish granted
2. permish granted and interim relief not granted
3. neither granted.
all these options could lead to one or more option being appealed by either party and I have put the CoA on notice.
With regard to what is going to happen on the ground we no understand no PBs are going to be administered before November.
AM i have a prof commitment on Friday – can others attend in my stead
J of course. thanks to all parties and counsel and instructing teams for submissions
prepared under pressure of time. It's obviously an important case and that's clear from the attn being paid to it by everyone.
[judge rises. everyone desperate to get out of court. it's boiling]
I have to attend a family event. I was hoping to get a write up to you tonight. That won't happen. However I do have loads of paperwork to go through which will better inform a report which I'll publish tomorrow.
Thanks for reading. Bye.
