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Legal opinion and legal advice: the “paused” NICE guideline for “ME/CFS”

September 1, 2021

Disclosure: I have lived with the discrete illness myalgic encephalomyelitis since 1981. I have written extensively about the NICE process (amongst other topics) in relation to this illness. I work independently and I am not affiliated to any organisation or group in the ME community. I am a barrister, called to the Bar in 1987. For more information see About

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For the full background to this post see previous post here.

Summary for new readers

In 2017, the English National Institute for Health and Care Excellence (NICE) began the process of updating the dangerously out-of-date guideline for “ME/CFS” (myalgic encephalomyelitis/chronic fatigue syndrome), originally published in 2007. This guideline recommended treatments which many patients have long found to be actively harmful.

After several delays, the draft guideline was published on 10 November 2020. This draft removed/downgraded the most harmful treatments from its recommendations and, as such, was broadly welcomed by the patient community. On 4 August 2021, the new guideline, marked “FINAL“, was circulated to stakeholders who had commented on the draft version.

By this stage, the guideline committee had approved this final version and, according to the NICE manual, the NICE Guidance Executive would now have signed it off. The fact that it was then circulated to stakeholders indicated that the process was now closed and completed.

According to NICE’s “Main stages of guideline development“, the publication stage began at this point. Publication to the world at large was scheduled for 14 days later, on 18 August. The document was to remain confidential until then.

Just after 3pm on 17 August, less than 9 hours before the scheduled time for general publication of the new guideline, NICE notified stakeholders that it was “pausing” publication. By this stage, only exceptional circumstances could have derailed the process. Thus far, NICE has failed to provide evidence of any such circumstances.

The “roundtable event” proposal

After eleven days of consternation and confusion in the ME patient community, NICE issued a statement which included the following paragraph: 

The [roundtable] meeting, which will be held in September 2021, will have an independent chair and will include representatives from patient organisations and charities, relevant professional societies and from NHS England and NHS Improvement, NICE and the guideline committee. 

Given that the process of updating the guideline had already been completed, it’s somewhat puzzling to see what purpose this event could possibly fulfil. 

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Legal opinion via Twitter 

On 28 August, I composed an 18-tweet Twitter thread as follows: 

Thread on @NICEComms decision of 17 August to pause
publication of new guideline on “ME/CFS”. This thread
sets out my view on current legal position.

Like all public bodies, @NICEComms has a wide discretion in how it operates.
However, when the decision to pause was made, the process had been completed,
signed off and the final document had been distributed to stakeholders.

Thus far, @NICEComms has failed to provide any evidence of exceptional
circumstances in order to justify or clarify its decision.

Media reports suggest that external interference at the 11th hour caused the decision
to pause publication of the guideline. Publication had already been delayed by 4
months for full and final consideration therefore this is not a valid reason.

On 27 August @NICEComms released a statement proposing a roundtable meeting
in September “to better understand the issues raised and determine how it can gain
support for the guideline to ensure effective implementation”.

The process of updating the guideline commenced in 2017. It had already been
delayed several times. By this stage, this explanation is therefore not credible and the
process has lost its legitimacy.

Stakeholders who participate in the proposed roundtable meeting run the risk of
legitimising a process which now lacks legitimacy as a sole and direct result of the
actions of @NICEComms.

At this point #ME orgs should as a precautionary measure be seeking independent
legal advice before deciding further action. This advice should include possibility of
commencing judicial review (JR) of @NICEComms decision of 17 August to pause
publication. TIME IS OF THE ESSENCE.

JR proceedings must be commenced within 3 months of the date of the decision in
question. @NICEComms anounced its decision to pause publication on 17 August
therefore time runs out on 16 November 2021. By the time the roundtable meeting
has taken place, time will be running out.

Last week, I was involved, by invitation, in a group email conversation with senior
reps of the #ME community. On 25 August that conversation ceased abruptly without
the courtesy of any explanation to me. Hence this thread.
END OF THREAD.

ADDITION to thread to address concerns about reprisals against stakeholders who
decide not to engage in roundtable meeting:

This situation has come about because of an error by @NICEComms . It is not as a
result of any action by #ME patient community stakeholders. It is therefore for NICE
to correct its error, not the #ME community.

If @NICEComms chose to exclude already recognised legitimate stakeholders from
any future part in the process, then that would compound its initial error, be acting in
bad faith and would be unlikely to survive legal scrutiny.

As I said in a recent blog post:
“If NICE is planning to open up a new consultation process on its guideline for
“ME/CFS” then it must clarify its position immediately and communicate this with
full transparency to stakeholders and the general public…..

…..If NICE fails to provide this information, then this amounts to a breach of its duty
to properly exercise its statutory functions. If there is no proposed plan, then NICE should publish the new guideline of its own volition without further delay.”

So – what is the purpose of the roundtable meeting?

According to the ME Association: “Representatives from stakeholders – which
includes both MEA and ForwardME – will be invited to this roundtable meeting”.
Invited by @NICEComms ? How will that process be transparent and inclusionary?
And an “independent chair”? Appointed by whom?

@NICEComms is no longer an independent body in this guideline review process.
NICE sacrificed its independence when it capitulated to external interference. This
means that the whole process is now flawed.

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Legal advice?

As I said about halfway through the thread: “At this point #ME orgs should as a precautionary measure be seeking independent legal advice before deciding further action.” The particular emphasis here should be on “independent” ie. from professional lawyers who are experts in the field of public and administrative law. 

On 25 August, in the group email conversation with senior representatives from the ME patient community (see above thread), I was asked for my recommendations, should the group decide to seek legal advice. Given this request, it would appear that, at this stage, this group had not yet sought independent legal advice.

I replied that I could provide recommendations but I needed further information in order to do so. I also included this: 

Preparations should be made to instruct an appropriate legal team in the event that NICE fails to correct its error by either publishing the guideline or providing credible reasons for its action on 17 August.

At this point, the group email conversation stopped without explanation.

Two days later, on Friday 27 August, NICE issued the second statement, proposing the “roundtable event”. Before the end of the day, in a Q&A explaining their decision to attend the roundtable, the ME Association Facebook page stated: “ForwardME [an informal coalition of charities and groups] has received legal opinions on the various options available from a number of sources.” The meaning of this statement is unclear, particularly given the sudden change in circumstances and legal position caused by the “roundtable” announcement. 

What now?

Who knows? Presumably, the “roundtable event” will take place at some point, probably as a virtual meeting. Some people will attend. Things will be discussed. Preparations for all eventualities may or may not have been been made. 

The outcome is anybody’s guess.

This is not how due process works.

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With thanks to @BenDeNevis1 on Twitter for creating the Threadreader.

 

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