NHS Homeopathy #6 - British Homeopathic Association lose Judicial Review

The British Homeopathic Association's (BHA) application for judicial review of NHS England's (NHSE) consultation Items which should not be routinely prescribed in primary care: A Consultation on guidance for CCGs (Consultation)  and subsequent guidance was discussed here at great length.

The application was accepted. The hearing took place between 01/05/2018 and 04/05/2018. The ruling of Justice Supperstone was published on 05/06/2018.

Supperstone ruled against the BHA.

Preliminary detail
The ruling reveals the BHA made application for judicial review on 20/10/2017 and that the rolled up hearing was ordered by "Yip J" on 20/12/2017. It must be stressed that granting of a rolled up hearing - where the application for judicial review and the review itself are (potentially) heard together - is unusual and potentially wasteful.

As part of the judicial review process, both sides will have made written submissions to the Court - which they also would have to share with each other. These submission can be obtained by Freedom of Information Act 2000 (FOIA) requests but it is unlikely that they would add much. However, the ruling does contains some hints of the what was in them. Interested third parties could, in theory, also have made submissions at this point. It is unknown whether this is the case. Two interested third parties - the Patients and Friends of Anthroposophic Medicine and the Friends of the Royal London Hospital for Integrated Medicine - are mentioned but did not actively take part in the hearing.

The BHA amended their application on 22/01/2018. They also effectively made another amendment on 16/04/2018.

Legislative and Factual Background
The ruling contains information on the relevant legislation but it is very dry reading. There is also a section that details the process of the Consultation. There is nothing particularly remarkable about this if one is familiar with how public consultations work.

Grounds for Judicial Review
The BHA started off with nine grounds but (likely on legal advice) these were reduced to four, which are -

1. NHSE failed to consult fairly by failing to provide consultees with sufficient information to enable them to give a meaningful response to the consultation and failing fairly to summarise the homeopathy issues the consultation was considering and/or NHSE misled consultees and/or failed to consult on alternatives
2. NHSE failed to consult at a time when proposals were still at a formative stage and/or there was a substantial risk that it had pre-determined its decision to withdraw support for homeopathy
3. NHSE has breached the public sector equality duty contrary to s.149 of the 2010 Act
4. NHSE has no power to issue the Guidance under s.14Z10 of the 2006 Act

Point 4 was added very late in the day. Point 1 is the crux of the BHA's argument and merits further discussion. There are several elements to it -

1. NHSE has failed to give sufficient reasons for its proposal to permit of intelligent consideration and response
2. NHSE failed fairly to summarise the homeopathy issue the consultation was considering
3. Having placed reliance upon the 2010 Report of the House of Commons Science and Technology Committee ("the 2010 report") NHSE failed to place the report properly in context
4. NHSE misled consultees and/or failed to consult on possible alternatives to its proposal

The ruling then goes onto discuss several important cases revolve around fairness.

Something interesting to note is that the BHA did want to an "expert" witness statement from Dr Peter Fisher to be considered as part of their submission, yet this was withdrawn during the hearing.

Submissions and discussion
Typically, in a judicial review hearing, the complainant's barrister talks through their client's submission, then the defendant's barrister will talk through their's and finally the complainant's barrister will speak again. Remember, that both parties will have seen the other's submission. No cross examination will take place.

The ruling is not a transcript (transcripts tend to make for very dull reading). What is does do is examine the points in the BHA's submission, NHSE's response to them and discusses them before making a specific judgment about the point.

Perhaps the BHA's position on Point 1. fairness is best summarised by -

1. Summarising the Claimant's case on day one of the hearing, at the outset of his oral submissions, Mr Clayton described it as a fairness challenge to the consultation based on the view in the consultation document that homeopathy is not clinically effective. He said that the consultation process was unfair because it misrepresented the true position; there is, he contended, plain evidence that homeopathy treatment does work in particular cases; and what the case boils down to is a debate about scientific method.

Richard Clayton was the barrister representing the BHA. Much was made of the NHSE's "reliance" on the 2010 Report of the House of Commons Science and Technology Committee (Report 2010) and that it somehow misrepresented understanding of homeopathy. That there was a failure to mention the Government response or that there had been an Early Day Motion signed by a number of MPs. Clayton stated that the Report 2010  "was seriously unbalanced and inaccurate and NHS England acted unfairly in failing to provide a fair summary of the complex issues it was consulting upon."

The original consultation document did state that - 

In 2010 a report by the House of Commons Science and Technology Committee, found that the use of homeopathy was not evidence based and any benefits to patients was down to placebo effect. The group agreed with the findings of the committee for the lack of evidence and considered homeopathy suitable for inclusion in the proposed guidance. 

The opinion that the Report 2010 is "seriously unbalanced and inaccurate" is a minority one and the NHSE consultation document is a fair reflection of the conclusions. The consultation document does not say anything that is out of line with medical and scientific consensus.

Clayton goes on to claim that referring to the Report 2010 is problematic for a whole host of other reasons such as "not intelligible to the ordinary consultee". Clayton also made arguments over the meaning of words and phrases such as "efficacy" and "clinical effectiveness".

Supperstone did not agree.

1. I reject Mr Clayton's submissions on the Gunning (2) criteria, essentially for the reasons advanced by Mr Jonathan Moffett QC, who appears for NHSE. I agree that the information that was provided to consultees was sufficient to enable them to give a meaningful response. Supporters of homeopathy could not have been left in any doubt that they needed to provide NHSE with evidence that homeopathy actually works; and this is exactly what the Claimant sought to do.

Moffett was the barrister for NHSE. And later.

1. It was made clear to consultees that the reason why NHSE was proposing to include homeopathy on the list of items that should not routinely be prescribed by GPs was the lack of robust evidence that it actually works. Consultees therefore knew that, if they opposed the proposal, they should point to evidence that homeopathy actually works, and they were afforded the opportunity to submit such evidence. The fact that the Claimant did exactly this indicates that certainly it had sufficient information to provide an informed response.

Particularly telling is -

1. Mr Clayton argues that there is "a legitimate scientific debate" as to whether homeopathy works. However I agree with Mr Moffett that it would not be appropriate for the court to pass judgment on the legitimacy or otherwise of the view that homeopathy works. NHSE accepts that there is a body of opinion, to which some practicing clinicians adhere, that homeopathy works (and that there is evidence to that effect), as the Select Committee report made clear. On the other hand, as Mr Moffett points out, representatives of professional organisations such as the Royal College of General Practitioners, the Royal College of Pharmacists, the British Medical Association and the Academy of Royal Medical Colleges sat on the Working Group and were involved in the development of the guidance. In any event the legitimacy or otherwise of the debate is not relevant to the issues before the court. What NHSE was consulting on was its provisional view that there was no robust evidence that homeopathy actually works.

This has implication for the context and scope of the hearing. Homeopathy is not "on trial".

As for Point 2, that NHSE had already come to a determination, Clayton's arguments revolved partly around a Radio 4 interview given by Simon Stevens, NHSE's chief executive on 31/03/2017 (several months prior to the official launch of the consultation and before any decision as to include homeopathy in it) in which when asked a direct question about homeopathy responded that homeopathy was ineffective and a waste of money. They also revolved around wording in the press release of 21/07/2017 that homeopathy is "at best a placebo and a misuse of scarce NHS funds". Clayton argued that both represented determination and the Stevens' statements represented the corporate opinion of NHSE.

Supperstone stated -

1. I reject this submission. In circumstances where NHSE was putting forward the proposal to consultees on the basis of an assessment of the evidence as to whether homeopathy actually works, I consider that NHSE was entitled to form a view on the state of the evidence before going out to consultation. It does not follow from that that NHSE had closed its mind to any further evidence that might be provided by consultees or that it would not objectively assess that evidence if it were received. The evidence is that NHSE engaged with the Claimant during the consultation exercise (see para 25 above), that the Claimant's written response was given careful consideration and that the SPS was instructed to conduct a specialist review of it (see para 27 above). Ultimately the decision of NHSE was made at a Board meeting and each Board member agreed with the decision. It has not been suggested that Mr Stevens exerted any undue influence over other members of the Board.

Point 3 about Public Sector Equality Duty (PSED) is quite tortuous to read but some interesting points appear. The basis of Point 3 -

i) The consultation process was exclusively online and, therefore, excluded some people with protected characteristics from answering the online consultation and from attending face to face events because the only way to find out about them or book a place was online.
ii) NHSE failed properly to inform itself and to take the necessary reasonable steps to gather relevant information in relation to specific protected groups.
iii) The EIA at no stage considered the impact of removing the exemption on paying NHS prescriptions on those with protected characteristics, particularly the elderly and those with disabilities.
iv) The consultation did not differentiate between removing single items of medication which treat one or two conditions from the prescribed list and removing the entire range of homeopathic treatments which are used to treat a very significant number of conditions.
v) The EIA failed to identify the increased impact on those with protected characteristics which results from de-prescribing homeopathic treatments, unlike other medications listed in the consultation paper, for which one or more identified alternatives are readily available.

It would appear that one of the BHA's ideas was that NHSE should examine every single prescription to determine whether patients were exempt from prescription charges. This would be impractical for a whole host of reasons as well as being incredible expensive.

Supperstone was more than satisfied that NHSE had fulfilled PSED. This is particularly interesting -

1. Mr Moffett makes the point that the first of these criticisms, that the consultation process was exclusively online, can only be a challenge to the decision as to how the consultation exercise was to be carried out. That decision was taken by the Board at its meeting on 21 July 2017. However, that aspect of the Board's decision was not challenged in the claim filed in October 2017; it was not raised until the amended grounds were filed on 22 January 2018, six months after the relevant decision. The explanation for the delay given by Mr Clayton is that it was not until shortly before the filing of the claim that the Claimant received letters from two individuals which put it on notice as to the problem. However this does not explain why the claim was not amended to include this complaint long before it was. The Burkett principle, on which Mr Clayton relies, does not assist the Claimant in the present case where the decision to consult took effect when the consultation commenced. I would therefore dismiss this ground of challenge on grounds of delay alone.

It would be foolhardy to speculate on why there was such a delay. 

1. As for the other three criticisms made by the Claimant (see para 78(iii)-(v) above) it is clear that the EIA did consider the impact of removing the exemption on paying NHS prescriptions on those with protected characteristics. The analysis proceeded on the basis that the effect of the guidance would be that patients who were previously prescribed homeopathic treatments would instead be prescribed the most effective medications that would achieve the best outcomes. That accords with the Claimant's consultation response which stated that patients who no longer receive homeopathic treatments on prescription will continue to use NHS services and move on to other prescription medications. The Claimant has not identified any further information that should have been obtained in relation to persons with conditions that are specific to particular protected characteristics.


2. I am satisfied that NHSE was rigorous in the discharge of the duty to have "due regard" to relevant matters, and that it was entitled, on the evidence before it, to conclude that the Guidance would not have an adverse impact on the statutory equality objectives, but rather, as the Analysis found, "would [enable] patients to have access to the most effective medications to achieve the best outcomes". That being so, I agree with Mr Moffett, it was not necessary to consider mitigation measures, it being NHSE's view that there would not be any discrimination.

These paragraphs are particularly damning. Whilst the homeopathy is not on trial, the implication is that patients currently receiving homeopathy will benefit by being prescribing the most effective medication and that thus homeopathy is of no effectiveness beyond placebo.

Conclusion

Justice Supperstone's ultimate decision was -

1. I consider that the grounds of challenge advanced at this hearing are arguable, albeit in the case of the vires ground, only just arguable. Permission will be granted on all four grounds. However, for the reasons I have given, none of the grounds of challenge are made out. Accordingly this claim is dismissed.

The language here is confusing. This is because the hearing was rolled up. The first two sentences effectively allow the application. The latter two effectively throw the judicial review out.

Costs
No mention is made of costs but it is possible that the BHA may have to pay NHSE's legal costs as they lost. Whilst the £30k+ the BHA raised via crowdfunding etc may (mostly) cover their own legal costs, it would not cover NHSE's and they can only be guessed at (although FOIA request could obtain them).

It is worth pointing out that the cost to NHSE goes beyond legal costs. Some staff will have been diverted from their normal duties to deal with this. 

Appeal
It is unlikely that the BHA will appeal. Leave for appeal is unlikely to be granted and even if it were, unless they can magic up more compelling arguments an appeal would be extremely unlikely to suceed. There would also be the matter of costs - which would likely be higher than for judicial review. Whether supporters would fund an appeal is moot given the BHA's failure.

Whilst the BHA seem largely indifferent to negative publicity, losing in Court twice is unlikely to endear them even to the staunchest supporters of homeopathy.

Reaction
There has been some media reporting of the BHA's failure. The Independent has a story as do the Daily Telegraph and Daily Mail. There also has been reporting in specialist media. Most of the stories quote Stevens -

There is no robust evidence to support homeopathy which is at best a placebo and a misuse of scarce NHS funds. So we strongly welcome the High Court’s clear-cut decision to kick out this costly and spurious legal challenge.

As previously mentioned, no mention of costs has been made. What is interesting is that some stories still paint the consultation results as a ban when it is clear that only blacklisting would be a ban. 

Social media reaction has been predictable. Critics see it as a victory for common sense and science, supporters of homeopathy are more mixed but some have invoked conspiracy theories as well as protraying the BHA as "brave". Bravery should not be confused with hubris. In relation to other NHSE matters, much has been made of Stevens having worked for UnitedHealth Group - some identify him with the "creeping privatisation of the NHS" but is has not been picked up. But both groups tend to forget that the judicial review concerned itself with whether the Consultation had been conducted correctly, not the validity of homeopathy as a treatment.

The BHA themselves describe themselves as brave in this statement. 

The BHA believed it had identified serious flaws in the way the health commissioning authority consulted the public on this issue and sought a judicial review.

Belief is one thing, the reality of the ruling something completely different. The whole statement is divorced from reality. Margaret Wylie, the chair of the BHA bizarrely stated -

It appears NHS England can fail to engage with patients properly on removing services and get away with it. That is not good enough, for it is important to remember that the real losers in this case are the patients who are now being refused a treatment on which they have come to depend.

There was also a statement on their crowdfunding page which covers much of the same ground.

The Society of Homeopaths contributed money to the BHA appeal that it call ill afford. Their news item has little to add but Mark Taylor as per usual had something to say -

It is hugely disappointing but it was encouraging to see the homeopathic community pull together to make the case. Through 4Homeopathy, we will ensure that the campaign to promote homeopathy and enable patient choice will continue.

The Friends of the Royal London Hospital for Integrated Medicine regurgiate a message from the BHA.

Impact
The ruling can only been seen a humiliating defeat for the BHA and CEO Cristal Sumner. It can also be seen as a defeat for UK homeopathy and its supporters. However, homeopathy is a fringe interest and NHS homeopathy represents a fraction of UK homeopathy. The BHA's defeat is unlikely to be of great interest to the public and only of passing interest to the media.

Critics of homeopathy have never regarded the BHA in a particularly favourable way but they have zero influence on the day-to-day activities of the BHA. They have some marginal influence when it comes to things like public consultations that the BHA become involved with but generally critics are less concerned in those circumstances with the reputation of the BHA and more the arguments they present.

Supporters of homeopathy tend to be uncritical of the actions of trade associations and bodies like the BHA. There is a tendency to support the "cause" even at various costs - including broader reputational damage as long as the key message plays to the core constituency. But in terms of financial support? The BHA are currently largely dependant on bequests and it's unpredictable income at best. They appear to have little in the way of active fundraising outside of that. True, they managed a crowdfunding campaign but on a very specific issue that they mislead supporters on.

What is going to hurt to hurt the most? Unknown, but several things but all will hurt.

From an activist point of view, it would be very easy to undermine the BHA in any future interactions that they might have with public bodies. There are some complicated legal arguments involved but the BHA have been shown to be not credible and unreliable.