Thread by @TransActualCIC

We're in the Royal Court of Justice today challenging the ban on private prescriptions of puberty blockers. We have permission to live tweet, and will capture what we can. Follow this thread for live updates throughout the day.

Housekeeping: The first thing which will happen is the determination of whether this case will be heard, followed by submissions from the respective legal teams. We are unlikely to receive a ruling today.

This thread will be an account of what happens only, we will offer further commentary when it is appropriate.

We have brought this judicial review against what we believe is an unlawful use of Section 62(1) of the Medicines Act 1968, targeted at preventing new private prescriptions of puberty blockers, without consulting impacted groups.

As we will argue, this has had further reaching consequences, with even those still legally accessing puberty blockers being denied them by GPs due to the chilling effect from this criminalisation of trans healthcare.

TransActual is one of two claimants who have brought this judicial review, the other being an affected young person (referred to as claimant YY) and their ‘litigation friend’ (claimant ZZ).

Housekeeping ends. Proceedings will begin shortly.

The Applicants (us, TA, as well as YY & ZZ), are represented by Mr Rob Harland (RH), and Mr Jason Coppell (JC).

JC is summarising the concerns: "These are individuals who were forced to seek treatment abroad by the abject failure of NHS specialist gender services, which led to years long waiting lists for NHS treatments."

JC: While exceptions are made in the text of the regulations, there is virtually no continuity of care available, as repeat prescriptions for those who have started treatment must be filled in the UK, and the number of providers willing to do so is vanishingly small.

JC: As seen in the evidence, the result is a large number of young people suffering from gender dysphoria, are unable to continue a course. Many are at risk of self harm and suicide. And many family members are concerned with keeping them safe.

JC: There have been self-harm and suicide attempts as a direct result of this legislation. Urges the court not to lose sight of the human costs of the legislation.

JC: Will first discuss the regulations, and then the Cass review, before the Secretary of State (SoS)'s statements.

JC describes the power of the act - to restrict supply of medications. The act details the requirements for consultation.

JC: the exception to the requirements in Section 62(3) states that the SoS can bypass the consultation if the SoS considers it is essential to make the order with immediate effect to avoid serious danger to health.

JC: this has been allowed previously on two occasions.

JC: our grounds is that there were defects in the decisionmaking process, "a number of demonstrable flaws" in the reasoning of the SoS. We do not know why the SoS decided that there was a seriuos danger to health.

JC: Secondly, the Cass report. (CR). In the defendants arguments that the Cass review 'concluded that puberty blockers should only be prescribed as part of a research protocol'.

JC: what was meant is that puberty blockers should only be prescribes *on the NHS* as part of a research protocol.

JC: it does also make recommendations about private prescription of puberty blockers. These are recommendations in the context of how private provision may impact provision on the NHS.

JC: For example, one discusses the potential impact of private provision on research protocols. And the other refers to concerns about the use of unregulated medications and providers not regulated within the UK.

JC: The Cass report recognised a proven benefit of puberty blockers. It was clear it was not recommending a complete ban on puberty blockers.

JC: the review found that not enough is known about the longer term impacts of puberty blockers about whether they are safe or not. Notes that medicines are only banned on safety grounds.

JC: The evidence is simply not there to justify a ban. Cass advocated for the prescription of puberty blockers within a research protocol.

JC: That is absolutely consistent. The Cass report did not find a danger to patients from Puberty Blockers (PBs), but that there was not enough evidence of their benefit.

JC: The defendant highlights a risk hypothesised a risk to neurological maturation. And risks to bone density. But it is unclear whether this is long term, there is a lack of evidence.

JC: in interpreting what Cass meant, we must turn to the York review (YR) [systematic reviews commissioned as part of the CR]. The first study, Carmichael et al, notes an increase in absolute measures of bone health, while Z scores decreased

by a degree not statistically significant.

JC: We have searched beyond the studies mentioned and found nothing which establishes long term risks or consequences. CR did not conclude any risks of long term consequences at all had been established, only hypothetical risk.

JC: it did not detail how serious those effects may be.

JC: the defendants have claimed that "the Cass review describes a model of care that was causing harm to patients", but does not cite a part of the CR. This is a misrepresentation of the findings of the CR.

JC: there is further misrepresentation by the defendant when they say that the review identified very "serious risks". There is no evidence in the report of the studies it analysed that any young person has come to significant harm as a result of taking puberty blockers.

JC: CR found no serious adverse effects reported, despite a history of their prescription over 10 years.

JC: The defendant refers to concerns surrounding GenderGP's statement regarding the CR. Describes their practice as "irresponsible and reckless". Says she also notes the "substantial and unquantified risks" associated with PBs.

JC: Links to a genderGP blog post which as far as we can see, is entirely factual in noting that "no medicine is ever 100% safe".

JC: There are international and other professional organisations of medics who have criticised the CR. Endocrine society, WPATH (describes CR as an "outlier") and EPATH. (World/European Professional Associations for Transgender Health)

JC: these are not malign actors, they are applying the world consensus position on best practices. Yet defendant describes the sourcing of private sector PBs as a 'loophole'.

JC: surprisingly, given strident criticism of genderGP, there was and may still be a plan to talk to genderGP about the number of patients they have and how to support them in context of this legislation. Officials thought this sensible.

JC: Officials wanted more time to consult on supporting the patient population and develop stronger evidence base, but the SoS rejected advice, took an early decision to ban PBs based on CR.

JC: Based in part on those press reports and a desire to act on "clinicians trying to circumvent the report's findings".

JC: In response to question from officials on what "justifies action now", which the SoS said was the Cass Report.

JC: We are told in the submission that arguments for overcoming the requirements of the act were being "worked up" but are not present in the final submission (unless redacted).

JC: there has been no response in the defendant's argument regarding what specific risks to patient safety were the grounds for this order. The implication that it was "all of the CR". But this is not acceptable when Cass' conclusions are so equivocal.

JC: There's a series of hypotheses about possible risks in CR. It was incumbent upon somebody at some point in the decisionmaking process, what was the danger to health this order was acting against. We can't find where that happened.

JC: Whatever the long term concerns held by SoS of people taking PBs, she recieved no clinical advice to support that conclusion. The need for clinical advice was recognised by officials and the SoS in a meeting in April.

JC: notes that SoS says in that meeting "at some point, a senior clinician needs to take view on this." But none was obtained regarding the dangers to health from PBs and the seriousness of that danger.

JC: refers to advice they recieved from NHS England. But it notes explicitly that advice is not related to specific risks of PBs. So why was that advice not obtained from anyone?

JC: Would usually be provided by Chair of Committee on Human Medicines (CHM). This advice was not provided by CHM.

JC: Disclosure last night of briefing note sent so CHM noting it is 'not in their remit' and says it is not seeking to 'set a precedent' of CHM consultation. It is clear this refers to the emergency process.

JC: However SoS did receive advice that ending treatment to patients carried significant risk. Clinical advice from NHSE noted that patients taking PBs are highly vulnerable, liable to self-harm, and that there are insufficient capacity for support services.

JC: It is clear from impact assessment that they did not know how many patients would be impacted. They did not know if there would be GPs and clinics willing to provide still-legal prescriptions.

JC: In the ministerial submission, notes that a delay of four weeks would 'limit the risks to continuity of care, which we cannot quantify'

JC: there is much emphasis from the defendants on the need to implement a ban prior to the general election. But it is not said why they must act before parliament is dissolved. When the law says that in an urgent situation they can bring a statutory instrument (SI) into force

JC: when parliament is not sitting.

JC: the real reason this was pursued is found in correspondence between officials, which says "the view from parli colleagues, is that the section 62 order is not urgent." and can be laid after dissolution.

JC: this process was the antithesis of an informed and evidenced approach. Based on misreporting in a newspaper, the SoS pursued an approach which carried risk of harm to patients, referred to repeatedly in memos to the SoS.

There is a back and forth at this point with clarifications from the judge. Some of this is inaudible to me, but is clarifying that the normal procedure would be to seek a view from CHM, and listen to the response, as well as engaging with patient groups.

JC: The reason it is necessary to consult more widely is that the safety of a medicine is largely a matter of science. But there are some inputs into that decision from patient groups based on the benefits a medication may have.

JC: Using the emergency process in section 62(3) should therefore require a very clear/obvious risk to safety.

JC: Defendants accept that the requirements for this emergency legislation are higher. But they say it is not necessary for section 62(3) to establish any particular risk, or degree of harm associated with that risk. Simply does not reflect a more onerous approach than 62(1)

Section 62(1) being the normal process, rather than emergency.

JC: The test for section 62(3) is whether it is "essential to make the order with immediate effect to avoid
serious danger”. Review of case law defining 'serious' ensues.

JC: Points to guides favouring undertanding serious as 'more than substantial' and 'connotes something towards the top end of the scale.'

JC: recent approach adopted in Liberty was to consider 'serious', in context of pharmacovigilance, a 'serious' adverse reaction should result in death, risk of death, hospitalisation, or persistent disability or incapacity'. This is not what the CR says of PBs.

Judge asks about whether level of scrutiny depends on whether human rights issues are considered. JC: protected characteristics of patients involved, risks to their safety, and also of their privacy and dignity. So scrutiny standard should apply.

JC: This is why human rights are relevant. And no answer on which impacts noted in Cass constitute serious risk.

Judge and JC examine specific case regarding medical negligence. Unable to follow all of this.

JC discusses submission made last night regarding European Court of Human Rights ruling yesterday on withdrawal of treatment from a trans prisoner.

Judge is taking time to read submission on this. JC notes relevance in terms of withdrawing treatment from trans prisoners being a human rights violation. Judge asks about withdrawal vs preventing new provision.

JC is summarising. On ground 1, we have covered already that SoS's personal position was that the CR gives rise to the evidence serious danger to health. We say that the findings of the CR fall far short of demonstrating serious danger to health as required by section 62(3).

JC: this is a demonstrable flaw in the reasoning of the SoS. with reference to the high bar for 'serious' danger to health. SoS must have misunderstood the legal test she was required to apply.

JC: SoS quoted as having "very low tolerance of risk to patient safety" which is not concordant

JC: defendent relies heavily on the precautionary principle, saying must be entitled to act based on idea that it might be the case that there may be harms in the future. We say that this cannot undermine the mininmum content of section 62(3).

JC: the case they cite, al farmer(?) does not justify their claims. Will not make full analysis of this case. We also argue that precautionary principle being misapplied, given greater risk to patient safety of immediate ban without pausing to find out whether there

would be continuity of care for those at risk in practice. Dept didn't know whether it would, they knew they didn't know, and they could have asked. They could have asked the first claimant (TransActual).

JC: SoS made the decision without 2 key pieces of evidence. First clinical or scientific advice on puberty blockers and whether their prescription constitutes a patient safety risk. Was not said in the Cass report, therefore advice needed.

JC: second piece of evidence SoS proceeded without, was information on how many patients were being caught by the ban, and whether in practice these patients would be able to access prescriptions.

JC: it having been identified to the SoS that there was a fundamental patient safety risk resulting from the ban, and uncertainty on whether there would continuity of care. Did not then seek to find out whether there would be continuity of care.

JC: Note in the submission from Dr Pasterski, the practical impact of this ban is wider as a result of a chilling effect. Includes for those already started treatment. There was no consideration of risks to this patient cohort.

JC: SoS was advised that there was a known, serious danger to patients who would be required to cease treatment. And possible risk of harm highlighted in the CR. SoS lacked the essential info to allow these to be considered against each other.

Judge asks whether it is relevant that clinical trials recommended in CR have not yet begun. Whether this is factor in preventing legislation from operating properly.
KC: yes.

KC: Notes that defendant made mention that the ban would not impact UK private providers - but there are no UK private providers. So they were misinformed about the impact of their ban.

Judge: concerned about time. Thought 1 day was optimistic.

[some missed remarks]. KC: SoS is asking court to believe that there is high risk of patient safety from PBs up to 18, at which point there is no danger.
Judge: But it is referring to children, has to be a cutoff
KC: Was not the case for previous drug banned under this law -

that caused harm to anyone who took it. There's no specific harm associated with PBs.

[discussion of time]
KC: drawing attention to the Gardner case. On policies relating to discharge of patients into care homes at start of 2020 pandemic. Court decided that SoS had acted irrationally by publishing guidance encouraging that,

KC: without taking into account risk of asymptomatic transmission of Covid among residents.

KC: And failed to make an assessment of balance of risks. This goes to the point previous about balancing risks of harm from the ban vs from the PBs being banned.

KC: For ground 2, we argue that even if the emergency route (section 62(3)) had been appropriate, there was partial, unfair and unlawful consultation. Notes of meetings from May 2024, says that this was "done through meetings, rather than production of consultation documents".

KC: saying "given the time constraints" means clearly this is then not a normal approach to consultation. Unclear that SoS is receiving full and appropriate information.

KC: there is no explanation or acknowledgement of the decision from SoS not to consult patient groups.

We are now returning from a lunch break.

Also correction, I slipped from JC to KC halfway through the thread. All of those should have said JC.

KC is discussing the consultation of relevant groups and the defendant's response to Ground 2 (failure to fully & fairly consult). Defendant says this would not have been possible because the decision was already taken.

*J*C (sorry Jason): Would do the secretary of state no credit if this were a foregone conclusion. Next point is that what occurred at meetings with stakeholders following 23 May didn't amount to consultation, given what was being discussed at those meetings.

JC: We say that is not consistent with the evidence. Discussions in early May was to explore policy options relevant for responding to the CR

JC: At the end of May, defendant is quoted as saying "there is a huge amount to do" to finalise this policy. Including exceptions, mitigations, protecting patients. The very things it would be valuable to seek wider views on.

JC: Defendant also claims that there is no statutory duty to consult patient groups. But this is not logical .... [missed a section] ... discussed a principle of fairness whose name was hard to make out.

JC: Moving to grounds 3. The strasbourg case (regarding access of prisoners to HRT) is highly relevant given it being about the impact on trans people of withdrawing medications, mental health impacts and consequences thereof.

JC: For the state to decide that claimant YY should not be able to access this medication, this is contravening their right to autonomy.

JC: This specifically refers to YY's art. 8 ECHR rights. The person in question has not been involved in the decisionmaking process in a way which would enable YYs interests to be heard.

Judge: how should SoS have proceeded?
JC: The consultation should have included representative organisations.
Judge: Organisations, but this is an individual.
JC: Organisations representing the interests of an individual.

JC: We make the point that it would have been sufficient to consult an organisation such as the first claimant (TransActual). It would have been better to have a public consultation, but we are saying that organisations would have been sufficient.

JC: The result was that there was no representation of the individual's interests in the decisionmaking process. There would have been time in this case to speak to the first claimant (TA) and others, if it weren't for the personal decision of the SoS.

We now move to the submission from the defendant.

On ground 1, we argue that the CR is the most up to date piece of advice in this area. It says it carries very serious, but unquantified, risks to health. It notes the massive increase in prescribing, not explained by increases in representation of gender diversity

This is Mr Jason Milford (JM)

JM: SoS was aware of the possible adverse effect of the potential adverse effect on mental health from the ban, and fully took it into account in design of the policy.

JM: on ground 2, we say that nothing the SoS did amounted to consultation. There could have been therefore no obligation to consult with representative organisations.

JM: What meetings there were may have amounted to limited and targeted consultation, and SoS was within rights to exclude the claimant.

JM: Returning to ground 1. We accept this is an emergency power, with expectation for it to be used in rare occasions. But threshhold is not as the applicant has said.

JM: On the risk of danger, it is entirely dependent on the view of the secretary of state and whether she could rationally hold the view that there was one. SoS opinion should have substantial margin of judgement. This was multifaceted predictive assessment.

Judge: does this not require higher level of scrutiny?
JM: No, the opposite, larger margin for judgement.

JM: Refers to a case which was judicial review o decision to make emergency control order on grounds of food safety related to cheese. The judge initially applied the wrong test on whether the control order was proportionate.

Judge: this isn't a UK case. Is EU law.
JM: we are saying this is the appropriate test.

JM: SoS is entitled to margin of error when balancing scientific information relating to public health.

JM: Also saying that regardless of this, SoS is able to, or even obliged, to consider a proportionate approach on the precautionary principle, and treat serious but unquantifiable risks as something upon which can take preventative measures.

JM: Discussing [al faber?] case regarding antibiotics safety in livestock. Hard to follow this part without the case documents.

*referring to the Wednesbury test

JM: There were two elements to the assessment of risk there. First what level of risk is deemed unacceptable. And second conducting scientific assessment. It is for community institutions to determine the level of response to that risk which is appropriate.

JM: Claimants are saying that a scientific assessment must be completed before precautionary approach can be applied. This is contrary to al-fava [antibiotics case - still don't know quite what they are saying.]

JM: Policymaking decisions of this kind, which involve significant risks, is where a substantial margin of judgement is appropriate.
JM: drawing attention to case relating to the ivory act, and whether it's provisions went further than necessary for safeguarding and welfare.

JM: judgement there was not dissimilar, there was not scientific evidence to justify the ban, but the precautionary principle was justified.

JM: Regarding claimant's approach to meaning of 'serious' here. Reference to the Liberty case defining serious as 'towards the top end of the scale'. Serious is an ordinary word, there is no need to redefine it,

JM: and there's no need to do so by ref to the connotations it bears in other contexts.

JM: Cites warning against drawing too specific interpretations of words in legal contexts. Referring to substantial in that case, highlighted it could have a range of meanings.

JM: In this case, 'serious danger' is in a public health context. Where a risk based approach is appropriate.

JM: Claimants drew a link to citation relating to 'serious adverse reaction'. We deny that analogy, because an adverse reaction has already happened, whereas a risk is a future judgement.

JM: Claimaints contend that test of serious danger is elevated because of human rights context. we say that cannot be right because there is nothing in strabourg or domestic case law to say that human rights should elevate the considerations for judgements on public health.

JM: State also has interests relating to article 8, in terms of a positive obligation to protect health.

Judge asks where they are in the bundle. JM says they are not sure as not speaking to things in order.

JM: referring to new case relating to refusal to provide access to a medication. Company offered to provide free of charge for compassionate reasons. Bulgarian state denied to authorise the medication.

JM: when balancing risks in this context, they are complex and based on uncertain scientific evidence. Court said that margin of judgement given to SoS must be a wide one.

JM: We say that is the best illustration of Strasbourg's view on the matter, and that's why we reject ground 3 (violation of ECHR art 8).

JM: The case cited by claimants refers to an existing treatment, with a strong evidence base for it's efficacy, being stopped.

JM: Now want to turn to ground 1. We say that SoS assessment that it was essential to make the order with immediate effect was within her gift to reach. Her decision was not based solely on CR, but the scientific evidence relied upon was the CR.

JM: the CR is the best and possible only acceptable source of evidence on this, given the polarised nature of the debate. When scientific evidence is in short supply, we say that CR is that evidence and SoS is entitled to treat it as such.

JM: CR was informed by wide range of sources, including extensive stakeholder engagement. Took into account both scientific research and actual experience of gender questioning children and their parents.

JM: The systematic reviews commissioned were extensive. and notes that the CR did engage with representative organisations, including the claimant (TransActual).

JM: CR says reasons for increase in prescription of PBs is not explained by greater acceptance of trans identities. Also notes generally higher rates of mental health problems among young people in the UK.

JM: Range of societal factors at play. Extend of each will vary in each individual.

Thirdly, in that context, CR deals with risks and benefits of PBs.

JM: CR describes the 'original rationale' for PBs was to allow young people to better present as themselves and buy them time to think. [slight paraphrasing].

JM: But CR sets out that PBs do not buy time to think, because almost all people on them go on to take cross-sex hormones. And also noted no evidence of psychological benefits.

JM: CR noted that PBs may not be helpful for female young people in terms of being 'stealth' in future. Only for birth-registered males.

JM: CR highlights how little is known about long term effects. very limited understanding of how many people on them would have otherwise resolved gender-related distress in other ways. Possible PBs have medicalised an issue that would have resolved otherwise.

JM: CR notes that complex neurological changes are occurring at this time, partly driven by sex hormones, so PBs may have unknown impacts on that. Also, blocking normal sexual development deprives them of chance to know whether they would prefer other ways of being.

JM: We say looking at this on precautionary basis, we see a risk that is qualitatively serious. There is a dearth of good evidence. And it's entirely the other way round to the claimants claim that there's no evidence of a risk so nothing should be done.

JM: CR discusses impact on bone density, saying it's not yet known whether there is full recovery from short term impacts on bone density.

JM: true that Cass did not recommend a complete ban. But did recommend restrictions.
Judge: what does this recommendation mean in practice?

Judge: the recommentation for a research protocol. This would mean admission to this study, and therefore accessing PBs, would be at discretion of study designers.

JM: Yes. Can't answer detailed questions on this. Research protocol is a work in progress.

Judge: is CR saying that if you don't get into the research protocol, you shouldn't get treatment?
JM: that is the recommendation. Claimants said this refers to NHS not private prescribing. This is true. But the recommendations were made on the basis of risk which is unchanged.

JM: Claimant referred to York systematic reviews. Noted that most of what are listed as side effects are relatively minor.
JC: Intervening here. I did not say that...

Missed the end of that, but JM accepted he did not need to continue that point.

JM: there was no prospect of getting any further information beyond the CR without even more extensive research.

JM: CR also addressed mental health and suicide risks. This addresses the strong belief that gender affirming treatment reduces suicide risk. Says that suicide risk is comparable to others experiencing similar mental health challenges.

JM: So it doesn't make a difference to her ultimate recommendation.

JM: CR says about private prescribing that there is concern about GP's being pressured to provide PB prescriptions originally given by private prescribers. And those prescribed overseas.

JM: claimant criticised the witness statement when saying that the CR found no risks to health associated with PBs. The sentence is that CR criticised a model of care that was causing harm to patients, which we stand by.

Judge: that concern though is about the way patients are being diagnosed and prescribed medications.

JM: Yes, concern about irresponsible practices by GenderGP which predate CR.

JM: GenderGP responded to CR alleging it was transphobic and unreliable and they intended to continue prescribing.

JM: Following publication of CR, GenderGP published a blog. Conclusion that CR is a profoundly flawed document which could lead to great harm to trans youth.

JM: Also published FAQs, which included entry on 'how can I get access to puberty blockers'.

JM: Also in this section, is a sentence we argue implies GenderGP were using AI to provide diagnoses which could then be taken to a doctor.

JM: They also highlight the potential to use other drugs to delay puberty. There is a direct encouragement to obtain PBs from providers outside the UK.

JM: Then a categorical statement that the effects of PBs are completely reversible. We say that is recklessly contrary to the CR. And to the sentence noting that "no medicine is 100% safe". We say that gendergp is not giving good advice on safety of PBs.

JM: This is clear evidence supporting SoS predictive assessment that if the ban was done over a long period of consultation, bodies like genderGP would be encouraging people to seek alternatives during those months.

Judge: on the other hand, this review has been going on for years. No doubt parents and advisors had seen the writing on the wall, and those people had already done so.

JM: From point of announcement, we did see a rush of people getting what they needed - what they thought they needed - and imagine if that had been going on for months.
JC: That is completely mischaraterised.

[this was referring to him saying this was a quote from claimant.]

JM: SoS view was that CR was the evidence base. And this was supported by actions of NHS England.

[Was left aside whether the claimant said this]

JM: context is that a 15yo transgender boy was prescribed both PBs and cross-sex hormones by gender GP based on insufficient assessment

JM: we say that the SoS was correct to conclude that statutory tests were met on 6 areas. Risks associated with PBs. CR's conclusion that PBs should only be prescibed under research protocal. lack of UK authority authority of EEA prescribers.

JM: the risks associated with GGP in particular. And the delays which would have been incurred by slower action. And the risk of overprescribing during that period.

JM: Will move on and address other issues raised by claimant.
Judge: will this include impacts on those with existing prescriptions?
JM: yes.

JM: If one looks at the timeline set out, this was considered very carefully with multiple meetings. It is irrelevant that the CR did not say that PBs present imminent risk to health. It did say that it had serious, unquantified risks with little evidence of benefit.

JM: Claimants say CR refers to possible but not established risks. We say this is a misreading of CR. But el father case establishes that you must move forwards on the best scientific evidence available. SoS relied upon CR as a whole, in totality.

JM: Claimant referred to banning of medicines which have pass safety tests. That is true of PBs for it's licensed use, but not it's use to treat gender dysphoria.

JM: They said that SoS proceeded without key pieces of evidence. We say we did have CR, and we are also saying SoS did not seek further advice, contrary to claimant's interpretation.

JM: They said SoS did not get advice about ability of people to obtain repeat prescriptions. We say she got relevant evidence there. That those people would need psychological support.

JM: Here the SoS is specifically told there was insufficient capacity in mental health services to offer continuity of care.

JM: We recognised risk that GPs may not want to prescribe PBs even when those prescriptions are legal.
Judge: so the issue in my mind, in practice they can't access the medication even when entitled to
JM: We are saying the SoS was told that.

JM: the ban did say that this form of provision would be legal. So it was made entirely clear to GPs that they could.
Judge: that doesn't override the already restrictive guidance given to them.

JM: The SoS was entitled to consider that this was something best left to clinical judgement of GPs with guidance from their regulator. If GPs were unwilling to prescribe in those circumstances, then that's because it was inappropriate to prescribe.

Judge: there's a gap here. the reality is that services are overwhelmed by large numbers of people waiting months and months for treatment.

JM: SoS was well aware of that. Answer is not to say that there is a shortage of medical provision, so we should allow EEA presribers to continue when we do not trust their methods.

JM: That is how our system works, how we say it should work. No quick solution to the waiting lists.

JM: Third point made by claimants are that the exceptions made under the order fatally undermine the case. We say that the exceptions show, the permissino for continuing provision, show that SoS thought carefully about untinended consequences and

JM: rationally concluded that the balance of harm and unintended consequences is different in that case. Recognises that in practice the carve out is a narrow one due to GP uncertainty about legality.

JM: Regarding being more dangerous to stop than begin, cites NHS document saying that anyone trying to legally access PBs should avoid doing so and be aware of the risks.

JM: Issue of allowing prescribers who do not recognise safety issue to continue doing so.

JM: SoS has never suggested that the order was to bring private sector into alignment with NHS policy.

JM: They say the timing of the order is inconsistent with there being a serious danger to health. What had changed is that the SoS for the first had a clear evidence base (CR) of the risks.

JM: Letter from NHS England noting that private prescriptions may pose safety risks.

Judge: SoS had concluded that even if she was no longer SoS, the new SoS would be broadly in favour of CR. There are exchanges in parliament which support this. So there wasn't urgency to accomplish this before election.
JM: comes down to matter of convention.

JM: making any recommendations in this area would be a matter of controversy. During elections it was advised that controversial issues should not be laid during a pre-election period.

JM: moving on to ground 2. Detailed reference to a new case. Citing that consultation has a variety of meanings. Argues that for Gunning criteria to apply, decision must still be at a sufficiently formative stage that the views of those consulted might have influenced it.

JM: We are saying there was no consultation exercise. Looking at the critical meeting which was complained about, it took place on 14 Feb. in that meeting, consultation requirements were discussed

[hard to follow some of the last of what he said]

JM: The meetings described did not amount to a consultation exercise.

JM: after 23rd May, the proposal was no longer at a formative stage and the SoS had taken a decision. Clearly there were still elements of it being worked out. But we argue that no consultation could have influenced it at that point.

JM: If groups had been consulted then, they could have claimed it was a stitch-up because they weren't consulted earlier.

JM: We also say that even if this had amounted to consultation, we were not obliged to include the claimants. As noted, this does not apply when making a section 62 order in the context of an emergency.

JM: Were this to have been a consultation, it would have been unlawful on the basis of being unable to be a meaningful one.

[Hard to hear what is being said here - discussing appropriate tests for different kinds of section 62 orders.]

We are just back from a five minute comfort break and will be resuming now.

JM: On ground 3 then, relating to human rights of claimant YY. We argue that there is no case here, and the SoS was within the margin of judgement on public health matters.

JM: Not suggesting that article 8 is completely unapplicable, but that strasbourg has never held this before.
Judge: So article 8 is engaged?
JM: Yes. On both sides, because state has duty to protect health entailing art 8 considerations.

JM: second point here. Strasbourg has never held that art8 imposes a procedural obligation to consult groups representing a class of persons before making a decision on authorising medical treatment.

JM: This would then be a clear extension. Third point, its hard to see why medical treatment should be a special case, which means one has the right to be consulted, which wouldn't apply to other situations where personal autonomy is engaged.

JM: That would have huge implications on legislative process. There is precedent that such things would need to be enforced by parliament.

JM: They rely on two cases here. One is Stafford, which we think is an entirely different situation relating to medical records in a court case. The other case related to procedural obligations relating to climate policy.

JM: there was a requirement imposed there for engagement with relevant groups. We argue this is a climate change specific issue and is only for that context.

JM: This should not apply to claimant YY.

JM has now ended his submission.

There will now be a response from JC.

JC: On ground 1, relating to ability to obtain repeat prescriptions. The SoS was advised there was a greater risk to health for those who could be forced to stop treatemnt than would be posed by continuing treatment.

JC: they say that SoS was informed of the mental health risks and the risks of GPs not fulfilling legal prescriptions. Referred to three times that SoS was told this.

JC: "on patient safety grounds in order to continue continuity of care, we recommend that UK private prescribers be able to fill repeat prescriptions". There was no contention that there are private prescribers.

JM: there are GPs who can do that.
JC: but as we have seen, there are none who will in practice.

JC: There was understanding that those with existing EEA prescriptions would have difficulty in finding GPs who would prescribe that. But this underestimates the problem. In fact 99% will not. And there was no correction to the advice that private prescribers were a solution.

JC: Also said that provisions would be made to allow for GP prescriptions. But it takes no account of the reality that you cannot practically do that.
Judge: Or to go to cahms.
JC: or wait three months for cahms yes. SoS was not given indication of true scale of problem.

JC: Position is worse for minister of health for Northern ireland (NI), who agreed to the order on 28 May. In summary of proposals given to him, there is a reference to avoiding unintended harmful impacts saying "in the interest of their safety, the legislation will ban

-prescriptions for new patients only." There is no reference to the reality that this is not the case.

JC: So minister in NI knew nothing at all about this serious aspect of the legislation.

JC: discussions were had regarding other approaches to reducing harm from this .Longer time of recognition of EEA prescriptions for eg. This is the kind of thing which would have been properly considered in a consultation process, had the claimants been asked.

JC: Also still no details on what exactly the risks to health are, which SoS concluded were established in CR. He said there were multiple meetings when this was discussed. But cannot point to one, because there isn't one, in which this important aspect (specific risk) was discus

-sed.
JC: It cannot be the case that they say that Cass is the evidence base for this. CR did not recommend the ban.

JC: going back to CR. In relation to the hypotheses floated by Dr Cass, the defending counsel said that there was clear obvious risk. But as we have shown, the magnitude of harm being discussed was minor. But CR does not say anything about seriousness of those risks.

JC: There is real deabte to be had about those risks. Does a slightly reduced Z score in the short term present a big risk to health? I don't know, and the SoS couldn't have known either.

JC: Like the east side cheese case referenced [food safety case mentioned above] this is an exceptional emergency power with a high threshhold for its use. Not a blank canvas. We start with restrictive wording.

JC: Quoting ECJ saying that this cannot be based on hypothetical risks, which it considers are those which are not scientifically verified. Some verification of that risk is required. What we see in the CR about long term risks from PBs are hypothetical,

JC: and not scientifically verified.

JC: Going through all these risks in the report, we say all of these are hypothetical rather than verified.

JC: they dismissed relevance of our cited definition of 'serious', given different context. A predictive judgement. That is no answer at all. Whether PBs proved dangerous in past is absolutely central to the judgement of whether to ban them.

JC: and on human rights case law, they conceded in their submissions under ground 3 that article 8 was engaged. We say it was engaged and interfered with.
Judge: It was not clear what his position was.

JC: On ground 2. Defendant submission scarcely acknowledged that the consultation - what we characterise as a consultation - occured in two stages. Early May and end of May.

JC: Can't say decision had been taken in early may, and then in end of may couldn't consult because people would try to beat the ban - it had already been announced.

JC: it's clear that other stakeholders (pharmacists etc) were consulted, and the only groups left out were the ones representing patients.

JC: and that this was clearly considered to be a consultation based on what was discussed. And defendant referred to time restrictions. But this was a timetable imposed by the SoS for unclear reasons.

JC: Reason why TransActual (claimant 1) was not consulted was on the orders of the SoS.

JC: On art 8, we are not asking court to recognise new precedent. [Missed some of this.] Reference to the case law cited by defence counsel.

JC: it is the interference, ie. withdrawal of treatment, which creates the procedural obligation. It's not a complete answer to the case that the second claimant is not necessarily represented by an organisation such as TA.

Judge: Section 62 specifically refers to organisations doesn't it
JC: yes.

Response is over.
Judge: I will not be giving judgement now. You will receive that in due time.

That concludes the hearing, and this thread. Thank you all for joining us here.

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