Court 1 Royal Courts of Justice – 27 July 2026 – Day 1 of 2
210 tweets
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.
I finished doing Times Radio breakfast at London Bridge which finished at 10am and have just made it to court have literally just arrived so know very little about what to expect.
We have started with a discussion about various anonymity orders which have been made. I am unsure what they are so can't really make a contribution about them. Judge is keen to ensure media get all the skeleton arguments and docs as they are referred to, which is nice.
This is just a permissions hearing rather than the substantive hearing. Arguments have started with the applicants' barrister setting out his schedule.
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Angus McCullough KC (AM) is leading the way for the claimaints. I have the skeleton arguments. Here are excerpts from the Claimants (C).
AM is talking to his skele:
"Permission for judicial review: the Defendants and IPs have not identified any ‘knock-out blows’ in their [grounds for defence]. The very fact that the…
… Defendants [D] revisited their initial approval of the Trial between January and June 2026 and required substantial modification to the trial protocol tends to indicate that the original decision-making was deficient…
… and the sheer volume of material and submissions provided in response to the Claimants’ grounds of
itself suggests that this is a complex case and the grounds are arguable."
"Whilst the Defendants and IPs contend that the challenge is an impermissible attack on the merits of the approval decisions, that is incorrect….
[IPs are Interested Parties]
… The primary challenge relates to a failure properly to apply the specific statutory safeguards that are imposed in relation to clinical trials involving children, in circumstances in which: (i) it is not possible to identify…
… which children may benefit from the treatment (including as specifically indicated in the participant information sheets): “We do not know whether the treatment may help your child” …
… (ii) the trial sponsor is unable to meet the request of the MHRA to include likelihood of
benefit and expectation of benefit as an inclusion criterion4…
… and (iii) where the applicable
regime expressly provides that “the interests of the patient always prevail over science and
society”.
AM the test for permission subs suggest there should be some heightened test beyond arguability should be adopted. We submit none of the facts articulated – suggest this should be the case.
Judge (J) there is some case law on this? Mass Energy is the one most often cited
AM yes. [start talking about "Planet B Earth which specificially considers Mass Energy" – AM hands a copy of it up]. It's a long judgment – but only a short bit at the end relates
J this is CoA?
AM yes – it derives from proposed Gatwick Airport expansion case.
[let's have a look at the Defendants' arguments (D) – AM says The South London and Maudsley NHS Foundation Trust (“SLAM”) and Kings College London(KCL) who are adminstering the Puberty Blocker (PB) trial say]
"Standing: 26. It is submitted that the Second and Third Claimants do not have sufficient interest under
s31(3) of the Senior Courts Act 1981 for judicial review to be granted. A personal interest in an issue does not…
… create a right to bring a claim , even if strongly held (R (AB) v A County Council [2022] EWHC 2702 (Admin) at [4-8] [AB/49] : R (Good Law Project) v Prime Minister [2022] EWHC 298 (Admin) at[21 – 23, 57 – 59] [AB/47] )."
"The Second and Third Claimant [Keira Bell and James Esses] are not directly affected by the Trial at all. They do not have sufficient interest. Being interested in the subject, being gender critical or having had treatment…
… for gender incongruence in the past , is not sufficient interest. Higher threshold for the grant of permission
27. The Second Interested Party submits that the court should adopt a higher threshold than…
… arguability to this claim – a “reasonably good prospect of succeeding” (see HyNot -v- Secretary
of State for Energy Security and Net Zero and another [2025] EWHC 2644 (Admin) [2026] Env LR
12 [AB/64])."
AM an oral permission hearing should be short and not. a rehearsal for the main hearing. It should be to ID any knockout blows.
[interruption so those on the link can hear the J better – he swaps out his mic]
AM – on standing. we've addressed this in our statement of facts and grounds appendix A
Having been given an intimation standing would be in issue. There is no point taken in relation to Bayswater Group standing [first C – BG going forward]
AM the test is to whether there is a "sufficient" interest that the second C Keira Bell (KB) and third C James Esses (JE) have to bring these proceedings. There is a statement from KB from which it is apparent KB has an acute personal interest from her own experiences.
She was prescribed PBs at 17, CSH at 18, progressed to surgery at age 20 and as she sets out she has previously been involved JR challenges (in partic Bell v Tavistock) in relation to children with Gender Dysphoria or Incongruence (GD)
CSH = Cross Sex Hormones
AM "in our sub, KB is evidently not in the "busybody" category – she is someone who is a C through a direct personal interest informed by her own experiences, including having been through the pathway starting with PBs and has been recognised as a proper C in JR proceedings in…
… this area".
The third C – JE – sets out his own professional interest and experience in bringing this claim. so my Lord, by reference to the authorities and we don't dispute any of the matters in them – JE is, too, has sufficient interest to have standing in this case
No challenge has been made to the standing of BG – so there will be no diff to costs by accepting KB and JE as having standing. And no impact at all on costs of D or IPs
AM – that's all I'm proposing to say on standing.
J yes
AM – then was going to pass baton to Mr Henderson to address reg 322.
[of the Human Medicine's Regulations]
[Alasdair Henderson (AH) is pointing the judge to the written reasons he is about to talk to]
AH don't propose to repeat the written subs – I wish to address what the MHRA say in their subs. On the ouster clause – if the MHRA interp is corr – this would not be a partial ouster clause it would be total. It would remove any court oversight of any administrative
decision made by the exec unless it was applied for by the MHRA. There is no authority for this. That's the headline. Now let me address them in detail.
AH on this issue as with the matters before you – I only need to persuade you it is an arguable point. If you think it is arguable you should give permission. First then – reg 322 (and I'm going to spend all my time in the authorities bundle) [oh good]
AH [refers to bundle] the operative language is the validity of a decision is not to be q'd in any legal proceedings…
J is your arg we find wording in Privacy International similar to [AN Other authority]
AH yes
J so where we get to is for the purps of this hearing
… where you get to is that there should not be a knockout point.
AH you have the point – do you want me to go on
J let's have a quick look at the wording on partial ouster
AH the MHRA refer to a series of cases with what they say covers the partial ouster
[we go to more authorities]
AH the MHRA are trying to say that because of the regulations no one with any interest in a clinical trial can bring JR unless they are the trial sponsor
AH but the authorities say anyone with a grievance can apply so long as they do so within 6 weeks.
AH There is a limited and circumscribed opportunity to challenge a JR and reg 322 does not block it.
[we go to a judgment by Lord Justice Glydewell]
AH one par comment in this case was obiter and was not on any submissions – it was a concession by Cs in that case.
[This is the relevant section being argued over:]
The Human Medicines Regulations 2012
Validity of decisions and proceedings
322. – (1) The validity of a decision of the licensing authority under Parts 3 (manufacturing and wholesale dealing), 5 (UK marketing authorisations), 6 (certification of homoeopathic medicinal products), 7 (traditional herbal medicinal products) or 8 (Article 126a authorisations) is not to be questioned in any legal proceedings.
(2) The validity of a licence, authorisation, certificate or registration granted or issued, or other thing done, in pursuance of a decision of a kind mentioned in paragraph (1) is not to be questioned in any legal proceedings.
(3) Paragraphs (1) and (2) are subject to the following provisions of this regulation.
(4) A person to whom notice of the decision is given may make an application to the High Court to challenge the validity of the decision on the grounds that—
(a)the decision is not within the powers conferred on the licensing authority; or
(b)a requirement of these Regulations in connection with the matter to which the decision relates has not been complied with.
(5) An application under paragraph (4) must be made within the period of three months beginning immediately after the day on which notice of the decision is given to the applicant.
(6) On an application under paragraph (4) the High Court may –
(a)make an interim order suspending the operation of the decision to which the application relates until the final determination of proceedings; or
(b)quash the decision, if satisfied that—
(i)the decision is not within the powers conferred by these Regulations, or
(ii)the interests of the applicant have been substantially prejudiced by a failure to comply with a requirement under these Regulations.
(7) If a decision to grant a licence, authorisation, certificate or registration is quashed under this regulation –
(a)a licence, authorisation, certificate or registration granted in pursuance of the decision is void; and
(b)the application process for the grant of the licence, authorisation, certificate or registration may be continued as if the decision had not been made.
AM is back on his fee to address Grounds (G) – following service of D's summary Gs, the C's have reviewed their own G and it has been conc'd we should not pursue parts of G3 which is re procedural element of the research ethics committee (REC)
however we say remaining aspects of G3 and all other Gs are arguable and we seek permission to pursue them.
In our oral subs we are nec selective, but I am proposing to focus on 3.
– I'll turn to specific wording – but those 3 features are the requirement for some direct benefit to the group for the trial and the need for the trial to validate data found in other sources.
There is a requirement for the ethics committee opinion. And par 5 – a list of matters which are specifically required to be considered, incl relevance of clinical trial and its design and whether the conclusions justify it. And if the trial is to include minors, extra considera
… tions.
[still going through consideration which refer to all clinical trials. Turns to Good Clinical Trials Practice]
AH [reads] of benefit to society, guided by good clinical practice, compliant with Helskini Best Practice and before the trial is initiated foreseeable risk has been weighed for present and future trial subjects and shall continue only if it has properly been weighed against risks.
J sorry for basic q – will all trial subjects get PB
AH yes, but they are randomised into two cohorts. First will get them immediately and then the rest will get them after a year. Everyone gets the drugs.
J will the trial subjects know which cohort they are in
AH yes as it was deemed impossible to give the drugs blind as it would become apparent who was not in one group over time
J how many injections and how often
AH six monthly – and then there is a point about what happens after the 2 year period which raises qs over what's been called "Destination Therapy"
J there is a difference between you about what clause 10 means
AH we say there is a requirement to demonstrate some direct benefit for the group of patients
J not for everything single member of the group or some – so some direct benefit
AH a proportion
J that's at least one
AH de minimis – doesn't have to be a majority
J what does this actually add – you know you have to weigh up the benefits to the ind against benefits that might provide benefits. What is this clause actually adding
AH the requirement from the existing state of sci knowledge that there can be a benefit. You have to be statistically confident there will be some benefit for the group.
J only for children
AH yes so it's an extra safeguard
J so when dealing with adults you could have a trial which would be expected to tell us something useful which would benefit soc, but with children it has to have benefit someone in that group
AH that is an important sig ind safeguard for those in this vuln category
J so if you give a completely healthy adult a medicine to see if it had unfortunate side effects – that would be fine, in adults but not in children.
AH there are conditions for all trial subjects
J but you can look beyond the group to society with adults
AH yes
J but this is not a cohort of healthy children. This is cohort of children with a very distressing condition and there is an expectation there will be some benefit
AH that's wrong on the current scientific evidence. The trial was recc'd on the basis that it's unclear these drugs
… bringing any benefit, which led to Cass saying it needed more research and the govt banning their use except to those already on it and those going for clinical trial
In par 32 of our skeleton we take it away from the present context by ref to a hypotheticl trial of weight loss drugs in children to illustrate what we say regulators need to be convinced of.
"To take an unrelated example to illustrate the point, say that a potential trial sponsor
wanted to test GLP-1 weight loss drugs in children, to see whether the benefits
outweighed the risks. The MHRA and HRA would need to be convinced that (a) the
evidence indicated there would be some direct benefit for the group taking part in the as
a whole; and (b) that for each individual trial subject the benefits justified the risks. It will
usually not be possible to say with certainty whether the benefit will outweigh the burden
for any individual trial child subject, but there must be sufficient evidence to believe that
it will. That would be fulfilled, in the ordinary course of events, by there being previous
research which tended to show this drug was effective in achieving weight loss and that
there were no major side-effects or other risks which meant the anticipated benefits were
not justified (the Declaration of Helsinki principles requiring that for children and others
unable to give informed consent there must be minimal risk or burden). These regulatory
requirements are accepted by the Defendants"
There must be sufficient evidence to believe the trial will be beneficial.
J the other parties are saying on the current state of the evidence, give the care of their selection and the protocols of the way the treatment will be delivered, the judgment of the regulators is that there will be some benefit for the children on the trial.
AH they don't put it as high as that. They were asked to say what benefit of the treatment
J that's to the ind
AH but they water that down to "reasonable prospect" but they never address the direct benefit issue
AH they sidestep it – they seek to address our challenge but do it by ref to the eligibility criteria for the inds and the reasonable prospect of benefit.
J isn't that a direct benefit
AH reasonable prospect is watered down and insufficient for minors as they can't say there
… is an expectation of benefit. And that is KCL's condition.
J if you give someone something which gives them a reasonable prospect of a clinical improvement in the manifestations of a distressing condition – isn't that conferring a direct benefit of them
AH not it has to be certain there is a benefit. They refused to reach that bar when challenged. They've gone for reasonable. They were told it was impossible to know there would be a direct benefit for some of the cohort, which is the standard for children.
J these are trials, so if Cass has said there is an evidence gap, we need some research. How are we going to have the research without the trial?
AH the answer in that lies in condition 11 – you have to have data already based on research which 'tends to show' that the drug
… will confer a benefit. You can understand why in scientific terms you say there is a gap, we need a trial, but you cannot do that in a trial for children. You need better research first.
AH "it's grounded squarely on the conditions that the regulations impose for the protection of children". There must be sufficient evidence to believe there will be a direct benefit to the group.
AH to answer the q of well how would such research ever be done. Firstly on the data linkage study of those kids who have already received the drug into adulthood. And also studies on animals.
AH you have the Witness Statement (WS) from Prof Evans about the work he does on animals. The work can be done – it's not an impossibility. There has to be direct benefit for the group. That's how that provision has meaning and effect. And it has been overlooked.
AH and principle 16 – interests of patient shall always prevail over the interests of science and society.
[with apologies I have been calling AM AH for a while – sorry. AM has been on his feet since we got to Grounds]
[AM is English-accented
AH is Scottish-accented, so you may need to read all that again]
[the rules we have been discussing above are from the Declaration of Helsinki en.wikipedia.org/wiki/Declaration_of_Helsinki]
AM we relied on the 1996 version principles 16 – 18. And then at 28, which is relevant to the risk and benefits – does your Lordship have 28?
J yes
AM which gives extra protections for those who can't give free and informed consent
AM so only if it confers personal benefit and has minimal risks.
Mr Millford appears to say that the above provision wasn't in the 1996 version. We say that is clearly a bad point and if we refer to the MHRA's own guidance and the current rules.
[Mr Millford is a D barrister]
AM we and his clients take the view that the Declaration of Helsinki starts at 1964 and taking into account its successive amendments.
[there is some bundle confusion – the J does not have the correct version as it was only recently updated to address the point they are discussing]
AM MHRA say themselves that even though a specific element of the Helsinki Declaration (HD) has been removed, there should be compliance with the principles.
AM but focus on the words in the principle of "likely" and "minimal"
AM we expressly rely on the failure to assess risk and benefit, as required by the MHRA regs and HD.
AM so by ref to contemp trial documents "why we say that there was an unlawful failure to meet the direct benefit criterion and it can be illustrated by the MHRA's request that was in line with recognising the direct benefit provision and KCL's response"
[go to correspondence in the bundle]
AM KCL write to MHRA on 9 Oct 2025 and the relevant point is in the second par of the letter and the initial part is the MHRA's request based on advice – sets out the objection and what was sought in able to allow the criterion to be met
AM can your Lordship read it
J so A sets it out and B is the response
AM A is the question as posed and B is the alternative suggested
AM so the inclusion criteria was that the patient would "likely" benefit and expected to be achieved within the parameters
J does expected make it into HD
AM no – likely does
J that can mean a range of things
AM it can, but par 10 of part 4 doesn't not incorporate
… anything to do with likely "some direct benefit of that group IS to be obtained from the trial"
J so when you read that with the HD you get to the point that benefit is more likely than not
AM at least.
AM so if we go back to supp bundle 4 p644 it was asked if it was going to benefit it was turned into reasonable benefit it might be achieved
J is there a danger here of turning clinicians into lawyers
AM these are regulators
J but the answer in this letter is by a clinician
AM yes
J we as lawyers are interested in more likely than not and prospects. Are clinicians so interested?
AM if they could have accepted what was asked of
them they would have done and we know why they couldn't… they can't show a direct benefit of the group because of the dearth of evidence.
J so you are saying yes we are focusing on the words,
but they reflect the fact the clinicians were being honest here
AM yes
J and were not able to say words that conveyed that the test laid down by the legislator had been met.
AM my lord that's the point and that's illustrated by Dr Cave's explanation as to why this change. DC's WS as it appears is in the core bundle…
… looking at par 81(b) on p333. What DC has done has prescied this through. and then she sets out what she has heard from Dr AB (as we are referring to him) who is the lead assessor. So CIT is MHRA's Clinical Investigations Team who were reaching the primary judgment
… on these responses and one of our complaints is that the MHRA had not taken the "direct benefit" issue into consideration. So DC told MHRA what she had been…
… told by Dr AB – that it would be "impossible" to predict outcome of trial on ind, but could only assess reasonable prospect of benefit.
AM this was not KCL using a form of words that meant the same thing this was KCL candidly admitting they could not meet the threshold which
was required. And this has been told to patients. [we go to the patient info leaflet to be given to participants – April 2026]
AM under the q "what might be good about taking part"?
J so are you saying you can't do a trial without showing it will help a child
AM no that there should be research showing that there is evidence the trial will likely benefit the group. As far as the individual is concerned it should either help or have minimal risks.
AM and. you need to consider those provisions separately and together.
J right okay
AM this is what KCL say cannot be shown, because they cannot adopt the standard and they can't even tell the candidates it will benefit
J so this point relies on your construction of what these clauses mean
[AM essentially agrees]
J so that's in essence your point and this point arises in relation to G1 and
AM Gs 1,2 and 5 and I don't want to labour, but ref to the KCL skele and how they seek to respond to
this point. Par 40:
"KCL’s documentation submitted to the REC explained that there were
plausible potential benefits to the group of trial participants, including reduced
gender-related distress, improved engagement with psychosocial support and
improved quality of life, while also acknowledging uncertainty (clinical equipoise)…"
J you are presumably putting weight on the word "plausible"
AM I am
J so if you had a disease – let's say a fatal disease a child has and you thought there was a drug which offers a reasonable prospect of curing the disease, but you couldn't say on evidence it was more likely than not, and it carries substantial risks, you could never have a
…trial.
AM you never have a trial, but you could potentially administer it therapeutically.
[J wants to go back to HD]
J those capable of giving consent if "likely to personally benefit them" and carries "minimal risk" – you mean there – more likely than not
AM yes
J so your interpretation is that you couldn't give the child the drug in the last example
AM no you have to separate it out from the group
J forget the group for the moment. par 28 of HD is about inds – it uses the work likely. Assume we are not in the minimal risk/minimal burden category. So if you cannot say of the drug that it is more likely than not to benefit them
personally, you cannot include them in the trial.
AM yes this is about recruitment to clinical trials. there is no control group in this trial, but if there was there is a requirement to show there is likelihood of benefit – this goes back to clinical equipoise which KCL
repeatedly refer to. we're not in that position because this drug is not a proposed cure for cancer.
J we don't have a placebo group – but you are saying that you cannot have a trial even for a drug which looks quite promising on your construction of likely
J if you have a trial of a drug with high risks you are saying that you cannot have that drug unless there's a higher than 50% chance of it curing you
AM My lord, no
J this trial is about finding out whether this drug is a good drug or not a good drug, and that's presumably
… what Dr Cass wants to find out.
AM yes
J let's go back to the ind. In my example if you have a drug which might cure a disease – 50% – but might take years off a child's life. I think your submission is that you could give the drug clinically, but you can't enrol the child
in a trial for that.
AM can't look at principle 28…
J even if the physician is saying this is a great oppo to see if this cures your disease, you can't have a trial
AM we have to go back to the conditions themselves which require a balancing exercise.
AM so condition 10…
J that I understand – a balancing exercise I can understand – these things are all quite nuanced. Clinicians have to decide between themselves where the balance lies between the benefits to the patient and the risk.
AM yes that criteria may be
… satisfied on your lordship's example. But then you have to look at the group.
[judge appears to be scoping out the parameters of the test he must apply to the criteria of the specific example – as per AM's construction. KCL/MHRA will put a different spin on it, I'm sure]
[lunch. we restart at 2pm]
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[we're back – this is a hearing for permission (and standing and grounds) to object to the government's proposed Puberty Blocker (PB) Trial at Judicial Review JR). Live tweeting continues…
[AM for C is on his feet.]
[lunch was a very nice £2.95 tuna and sweetcorn sandwich, a flapjack and a Pepsi Max at the Royal Courts of Justice canteen. Recommended]
AM in relation to the "destination therapy" (DT) issue we will adopt what we say in our skele – I appreciate I still have interim relief to get to. my core point re DT there is an exacerbation of the risks for those recruited to the trial…
… [we go to the bundle] in the penultimate par one sees the REC asks for a written guarantee that the open label extension – ie accessing PBs after the 2 year trial period.
J the stat instrument referred to in regard to D arg which prohibits supply of PBs save in clinical trial
J what is the effect of that? cannot be supplied at all in UK
AM correct
J so what is the open label trial?
AM doesn't exist yet, but it's a proposal that those who have been on the trial might get the drug after the end of the trial
J would that require a stat instrument?
AM it would certainly require another trial and similarly with Cross Sex Hormones (CSH).
J and NIHR is…?
AM the funding body. which stands for National Institute of Health and Care Research
J right
AM so this is an issue set out in our re-amended statement of facts and grounds. And then the related issue of "locking in" – historically 98% of PB users go to CSH to transition
J it's said against you it was in the past
AM there's no indication what the new
regime will lead to. There's no info on what the new rate is presumed to be.
J yep – so the DT issue is that the HRA did not adequately consider or factor in what is going to happen to the participants at the end of the trial.
AM – yes. It's heightened the risk of the trial…
… as there's no clear planning for what happens when it ends. So in relation to the open label extension that will only become apparent later on and there's no guarantee what will happen. Also issues with regard to access to CSH. it needs a trial formulated and approved.
AM the only commitment from the NIHR is that if there were a suitable trial, they're committed to the funding of it.
J so KCL were being asked can. you give an assurance and they said no we can't because we're not the regulators – what more could they say
AM nothing – it's what the regulator should say in response.
AM there's a regulatory and ethical approvals that will be required
J and there couldn't be an assurance about that – that would be [indistinct]
AM but there's a material risk in the time it takes to get to approval
J is there some equivalent instrument that stops the supply of PB as stops MAF (I think this stands for Masculinising and Feminising hormones)
AM in relation to our other grounds I think we have to rely on what we've set out that each of them is arguable and would meet the test of any heightened threshold the court might impose contrary to our submissions
AM i've spent most of my time on ground one with feed into two and five. We think the requirement for validation from other sources – animals studies, and the linkage study would meet the requirement. With this trial the regulatory requirements are simply not met.
AM the importance of the REC (research ethics committee) is essential for public confidence in this test.
J there was a WS – are you saying I shouldn't look at that
AM no look at it
J are you saying the WS is not reflected by the minutes.
AM yes
J they say at the relevant meeting
… the business was contracted at the next committee which [???]
AM what is said in the WS is that the names were agreed to sit on the subcommittee but the reasons why weren't recorded and they have been forgotten – we say that's not good enough for transparency
[think this is about the REC subcommittee who approved the protocols for the PB trial]
AM I must turn to interim relief
J yep
AM don't think there's a disagreement as to principles. We agree the permission threshold is cleared – a srs issue to be tried. The focus is on the balance of convenience and that means balance of harm to prospective trial participants.
And tho there will be suggestions of other considerations, we are certain it pales when considering potential harm to participants. ie inconvenience to clinicians running the study, and possible frustration from the trans community, but
a three or four month delays pales into insignificance when considering the importance of getting this right.
[discussion about witness evidence]
AM a delay of 3 to 4 months, it's significant to look at the numbers of those who might be affected. Dr Kingden has produced a WS
whic goes into the most detail about that. Distinguishes between the numbers considered for eligibility on to those who might go on to take part in the trial.
There is other evidence which produces slightly different figs. With regard to Dr Kingden's evidence, we see 10 or 11 who might be recruited before November and then another four in the following months.
The fig which Professor Simonov comes up with is 17. Dr Absuud says next three months, I think.
J when is it anticipated these inds might receive their injections of hormones
AM latest evidence is not during the period of delay. No one has yet been approved whilst we are
waitin for present position to be clarified.
J right – is there any indication of when… isn't that one of the key issues? That's the point at which if the administration of a drug which is harmful… it's happened… but that isn't going to be until
There's a suggestion it won't happen for a number of months. But the administration of the drugs is only part of it. It's the distress of being told they're going to get these drugs and then told the trial is invalid. The primary concern was one of "aging out" – those who would
as a result of the delay become ineligible – as DrK says – of the 10 -17 ID's it's unlikely many of them will be affected. if the trial is declared valid they could start with only 3 to 4 months delay. none of the witesses of the interested parties have ID's
anyone who might age out. It's entirely theoretical and moot.
The evidence is scattered over WS from Prof Bannerjhee, Dr Rabsuud, Simonov and Baroness Cass herself. But on analysis 2x SLAM witnesses… (one an art therapist and one a psychologist)
there is no indication there's a problem as one has a parent saying its no problem and another child is already on PBs.
J how is a child on PBs
[oppo barrister stands up]
OB either child has been on PBs since before the ban or has been sourcing them themselves
AM it is unlikely that any child who is hoping to be on the trial would take steps to make themselves ineligible for the trial
J is that true – with children who have been told there is a hold up with the trial might decide to take matters into their own hands. Is that not plau
… ible?
AM It might happen, but there's no evidence of the ID's individuals. It's presented as an abstract concern. If you feel there is a prospect you would be eligible why would you take the risk to render yourself ineligible.
J is that just a suggestion of yours?
AM my lord…
J because it seems to me very likely a child who has been told they're going to suffer another delay might start to source the drugs themselves
AM [goes to WS about accessing drugs] there's no evidence suggested that this
might happen. It might happen in a population with no access to a trial, but those who are connected to the trial already are invested in this process have a rational reason to "stick with it".
Noticeably neither the first defendent has not taken a view – they've expressed neutrality. KCL have sought to evoke a wider authority. Public interest. KCL and SLAM have no stat remit to protect the public interest.
J but this is a case which you're inviting me to form the balance of convenience – the harm that you are saying will be is harm to the individuals. But these inds, their parents, their doctors and the regulators all think it's in their interests for the trial to go ahead.
AM but the test of harm is objective not subjective.
J are there any other instances where a judge gives interim relief to a group of people who don't want it. Neither do their parents and neither do their doctors
AM the first C is the BSG
J but they are not PB trialist
AM we don't know that because you only need one parent to give permission to go on the trial
J is there any other analagous situation where the court has done anything like this
AM I don't know
J this is not about public interest when it comes to interim relief.
AM there is absolutely a PI at stake and just because my clients are seeking to uphold that without a direct personal involvement
J I absolutely understand why 2 and 3 claimaints feel strongly
about these issued. But when it comes to interim relief and the court is about trying to work out… this is not impermissable. It's just unusual.
AM the unusual feature is that those concerned are looking to get access to these drugs. IN my submission you should worry about
children being give strong drugs with which the outcomes are not certain.
J the interim relief is protect their interest. There are private law mechanisms. If a parent takes a decision re a child, that can be questioned in court.
AM we are asking what is the harm caused when there's no identified threat of aging out. Both as a matter of common sense and they analysis of both experts, but the relatively short period of delay that would be involved is less harmful than enrolling then potentially having to
withdraw when it came to giving advice to people about the banning of puberty blockers.
In our sub the paths were pursuing of permission cross the relevant threshold.
[AM has finished.]
Julian Milford (JM) KC is on his feet for one of the defendants (D) – either the Health Resesarch Authority or the Sec of State for Health and Social Care
JM the ethical consideration for this trial was considerable. [takes us to Dr Cave/K's WS]
MHRA's involvement started two years ago. KCL and MHRA first met in Nov 2024 to discuss what a trial would look like.
It is Dr Cave. She says in par 58 "It was explained that all the participants in the study were already under the care of NHSE' s specialist gender services and would undergo a clinical eligibility process before being approached for research, which involved assessment for eligibility by both their local clinical team and the national multidisciplinary team ("NMDT"). A
detailed consent and capacity checklist would need to be completed by clinicians over…
… multiple sessions, including 1:1 sessions with the child or young person (11CYP") and their parent(s), and at least one person with parental responsibility would need to provide consent. Participants inust have had persistent gender incongruence for a minimum of 2 years and must have a strong desire to II transition" and live as the experienced gender; and their request for puberty suppression must persist after receiving other care prior to the initiation of GnRHa."
J- how many people are expected to be in the trial
JM – 226
J – and the figure of 10 – 11 is who is in the frame to start immediately
JM yes
J – so how long is this trial likely to take
JM tries to explain
J but whats the relationship between the 10-11 and the 226?
JM prob best if KCL explain
JM par 62 of DrC's WS says: "In this case, a substantial team from CIT were involved in assessing the Trial protocol,
consisting of the Head of Clinical Trials, the Head of Pharmaceutical Assessment, and
the Head of Medical Assessment, supported by a team of four Assessors, under the oversight of Andrea Manfrin, the MHRA's Deputy Director, Clinical Investigations and Trials. In addition, the Interim Executive Director of Innovation and Compliance
(James Pound) was involved, together with three assessors; and four members of the
Safety and Surveillance Team (led by the Deputy Director of Risk Evaluation II)."
And par 63 says this: "The MHRA initially considered that the Trial should be considered by both the CHM
and CTBVE~G. The MHRA was fully aware of the very sensitive nature of the Trial and the importance of the welfare of the young people taking part in it and wished to make sure that it had the best advice available to it when considering the Trial
protocol"
[JM goes on to address the likelihood of the PB trial helping children. Refers to par 80 "KCL responded to the GNAs on 9 October 2025, submitting an amended version of the PATHWAYS Trial protocol (i.e., version 2). I exhibit this response as [EB-19.01/972-986] and the amended protocol as [EB-19.02/987-1099]. In particular, as concerns the GNAs set out at paragraph 75 above, KCL responded as follows:
a. KCL did not accept they should include a criterion that cYPs should have "completed" all other interventions before taking GnRHas could be considered. They pointed. out that the Trial participants were a heterogehous collection of young people with individualised treatment plans; and
… psychosocial interventions might continue during the Trial for some participants. However, they did alter the Trial protocol so that it stated: "The CYP wants puberhJ suppression for their gender incongruence and this care preference persists after _receiving other care deemed appropriate from the CYPGS and other services prior to the initiation of GnRHa". They also amended the protocol so that it stated as part of the inclusion criteria that "the clinician in the CYGPS leading on care for an individual patient considers they have participated sufficiently for their holistic health and well-being in other forms of care for puberty suppression to be
considered, in line with NMDT recommendations and this participation is reviewed by the NMDT". In other words, the protocol was amended to make clear that
both the lead clinician for any CYP and the NMDT had to consider that the CYP had sufficiently participated in alternative forms of care for GnRHa to be considered."
"KCL did not adopt the statement of "likelihood" of benefit proposed by the MHRA. However, they did modify the inclusion criteria to state: "The clinician
in the . CYPGS leading on care for that CYP considers that GnRHa for puberty suppression offers a reasonable prospect of benefit. That benefit might be achieved in
relation to qualihJ-of-life parameters (e.g., confidence in peer and family relations, participation in school and/or leisure activities, improved sense of well-being), mental or physical health."
JM we say they are asking the right question and getting the right answers in their design of this trial – it is a reasonable position to take.
[MAF is definitely Masculinising and Feminising hormones, sometimes described as MAF or MAF hormones. Not sure what was wrong with Cross Sex Hormones (CSH) but there we are.]
JM after the 4 sci dialogue meetings – there was an amended text for the PB trial in April and part of what the CSM discussed was the DT issue and it was decided it was part of the risk-benefit profile of the trial.
[JM making lots of points to say the trial and the DT issue were carefully considered, went through lots of people, who kept tweaking and suggesting changes]
JM none of the members of the CHM think the DT issues is enough of a reason not to go ahead with the trial.
J what if the trial goes ahead and there is a block on the pathway at the end of the trial
JM we are dealing with a range of uncertainties if there was no reasurrance whatsover, it would be understandable if it didn't go ahead, but there were enough reassurances in this case
J so you are saying all involved in the chain formed a view that the assurances provided by NHS England were enough to a point where is was acceptable to go ahead with the trial. Presumably the trial can be authorised, but if things change it can be suspended.
JM that is the position with many many clinical trials. It's something which needs to be weighed when deciding.
J ultimately you say it's down to the MHRA is all about rationality and when it comes to the latitude it should have its very wide.
JM that is the context in which the trial was given the go ahead. in par 147, DrC, says in terms that other than the COVID vaccines she doesn't know a single trial which has had so many resources thrown at it.
JM turning to the Ouster clause
J yep – could we have a short break. It's very hot. we'll come back in 5 minutes. And at least in my case I will come back without my robe on… [smiles]
Usher: Court rise!
[we filed out]
[judge has returned in a shirt and tie. Ms Richards KC asks permission if they might follow suit. J says "of course". There is an immediate and mass stripping on as the barristers divest their robes]
[JM is back on his feet talking about the Ouster situation. Referring to authorities]
JM just to start with general principles – the C's say there is a presumption against any stat wording that seems to allow total ouster – re interpretation of this [goes to authority]
[it is beyond sweltering in here now]
JM "the plain language of the statute will not protect the nullity"
[this harks back to the claim by D that Keira Bell and James Esses don't have standing in this case. Am quite certain now that JM is representing the HRA/Dept of Health]
[lots of authorities being referenced]
JM we say the right that is observed is as expressed in reg 322 regulation [see above]
J quite a big diff if you are C it's the diff between being able to claim within six weeks and not being able to claim at all for any reason forever
JM I accept that and I will come to it.
[back to more authorities]
[JM accepts there is a tension in the authorities]
J doesn't this therefore tend to suggest yours is not a knockout point
JM well my Lord you are able to look at the law and make your decision
JM can I turn to how the legal principles apply to reg 322 itself. We say when you look at the wording of 322 there are three steps in the reasoning. First that the grounds that a person when given notice of a decision can challenge reflects JR.
Secondly that must meant that 322.2 and 322.4 is that they are intended to oust claims asserting error of law to persons who notice of decisions have not been given. This excludes 3rd parties.
No reason to distort the v clear words that reg 322 that the legislator attempted to preclude the High Court from JR of this as that is what they state.
J so the JR fails because… it's a JR of a 3rd party decision
SM yes
J that's an awful lot of power in a tersely expressed par
SM yes, but that's undoubtedly what it means
The positive reason for the ouster is that it stops complicating a decision reached by responsible specialists. It does not stop further review by other bodies.
It's also not the only or main form of accountability. There are various forms of accountability – the MHRA, the Sec of State and the REC can be challenged. This is just the balance the legislator has chosen to strike.
JM now goes to grounds of claim – starting at Ground 1 (G1). The C have made no action to amend their re-amended non-pleaded claims, which don't work. Going to the pleaded claim…
The entire reason the MHRA considered the future for a trial of MAF hormones was precisely because it considered it part of the overall risk and benefit balance
J it was the reason why it was all reopened
JM yes
J the ultimate logic of the C arg was that the MRHA could never approve a trial unless there were onward treatment options and that's not how the risk balance equation works. We say this challenge as pleaded is not a proper challenge. It's a disagreement with the MHRA on benefit
and risk dressed up as an error of law.
RM in 2025 when the MHRA approved the trial – it was aware of the benefit risk test and applied it. And it was aware there were risks, but a positive risk/benefit balance for the participants in the study.
RM we are clear that this test, a pos risk/benefit balance for the individuals taking part in the study was the one to apply and one we have applied. The sideways attack on this is one by way of saying the MHRA applied a different test because you allowed a different test.
J did you hear the points I made to AM about minors
RM yes I'm coming to that.
J well what about them
[sorry – JM has become RM – going back to JM]
J is the protection of minors clause says that you can't do trials on kids which aren't benefitting those kids. You can do that
for adults. They might be able/allowed to do a drug trial for which they don't have a condition which might benefit people who do or wider society, but you can't do that with children. It has to designed to a benefit to the cohort of the trial.
JM which is absolutely the case
here. And if you set the bar too high you could never do any trial, but you can't set it to say that the majority of a cohort should benefit. That would be impossible.
JM my lord I am looking at the time. I can finish quickly tomorrow morning given the temp now
J i am v keen that everyone should get the time I need. You've got 5 mins of injury time.
JM I need half an hour tomorrow
J let's aim to start a little bit early tomorrow
JM I think I'll be alright
J AM I am quite keen to ensure you are not squeezed on your reply – shall we say 10.15am to ensure you get your time to reply.
AM yes my lord thank you
J okay 10.15am tomorrow then
Usher: Court Rise!
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