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NICE developments: preparatory action for a judicial review of the decision to pause publication of the new guideline for “ME/CFS”

October 11, 2021

Disclosure: I have lived with the discrete illness myalgic encephalomyelitis (ME) since 1981. I have written extensively about the current NICE process (amongst other topics) in relation to this illness. I am a barrister. For more information see About.

I work independently and I am not affiliated to any organisation or group in the ME community.


Summary of events so far 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the English National Institute for Health and Care Excellence (NICE) began the process of updating the dangerously out-of-date 2007 guideline for “ME/CFS”. After several delays, the new guideline was completed and signed off by NICE’s guidance executive. On 4 August 2021, it was distributed to NICE representatives and qualifying stakeholders. The document was to remain confidential until 12.01am on 18 August 2021.

scales of justice

ME patients trying to obtain justice

According to NICE’s own manual, the distribution and publication on 4 August completed the process. No further changes could be made from this point onwards, save for minor corrections.

On 17 August 2021, NICE “paused” publication of the document but gave no credible explanation or detail of any exceptional circumstances justifying its extraordinary action. In addition, the “pause” in publication meant that NICE claimed that this final version of the guideline, already distributed to numerous parties, remained confidential. (I have disputed the validity of this claim of confidentiality in an earlier post.)

It became clear that this eleventh-hour development was the result of external interference by representatives of the Royal Colleges and NHS England who were opposed to the new guideline. This is in direct contravention to NICE’s own prescribed procedure and such an action at this late stage should have been impossible.

Since then, NICE has issued two statements. The first, on 27 August gave details of a roundtable event, to be held in September chaired by an “independent” party. This was then updated to 18 October. Selected representatives from the ME community and other parties would be invited to attend subject to signing new non-disclosure agreements (NDA’s).

The purpose of this event was to “gain support for the guideline to ensure effective implementation”, despite the process having been completed, signed off and the document already distributed to an extensive number of people.

A second statement was issued on 21 September 2021 further attempting to justify this bizarre series of events. The statement also announced Professor Dame Carol Black as the “independent” chair, someone whose history has made her completely unacceptable to many in the ME patient community.


Pre-action for a judicial review of NICE’s decision to pause publication on 17 August 

I have written about the possibility of a judicial review of NICE’s decision on several occasions eg. here and here. I would always advise a cautious approach to such an action as the threshold for success is very high and litigation is very stressful for anyone, especially a patient living with ME. However, given NICE’s extraordinary conduct, this seems to be a valid response to the situation.

On 1 October, Peter Todd of Scott-Moncrieff solicitors issued NICE with a letter before claim under the judicial review pre-action protocol (4 pages).  The claim is being made on behalf of a child who, as such, is entitled to complete anonymity. The grounds for challenging NICE’s decision are procedural impropriety and irrationality.

On 6 October, shortly after the expiry of the time limit for a response, NICE replied. It had instructed DAC Beachcroft solicitors, the same firm that it had used to defend itself against a judicial review of the 2007 “CFS/ME” guideline. The letter sets out NICE’s defence of its decision to pause publication of the guideline. The letter can be read in full here (dropbox file – 8 pages).

I have done a full commentary on NICE’s letter at the end of this post. However, it can be summarised as follows:

Our client doesn’t agree with your client.

NICE was exercising its wide discretion in a perfectly proper manner.

*Rattles sabre* 

[Note: whilst the letter may make for difficult reading for many members of the ME community, it is a standard solicitor’s letter and its tone is completely predictable, despite sounding highly inflammatory to anyone unfamiliar with this kind of correspondence. Every lawyer is required to follow their client’s instructions. Personal views play no part in the drafting of correspondence or other documents.]

The current position

Peter Todd, who is representing the claimant ME patient, has taken an unusual and very welcome stance on full transparency and has been tweeting updates for this action. His Twitter profile can be found here.

His latest tweets about the case on 8 October have provided the following information:

Pleased to confirm the Claimant has today been granted legal aid to commence proceedings for judicial review against NICE re the decision to pause publication of the new guideline on diagnosis and management of ME/CFS…..

… busy preparing the papers so I can file and serve proceedings in the High Court. Ian Wise QC being instructed to settle the statement of facts and grounds Currently envisage serving proceedings by close on Friday 15th October.

[Update 15 October (new tweet): As the roundtable is on Monday, I am deferring issuing the claim until after, so we can show that issues being raised were previously considered in the development stage, and it is an impermissible attempt at a second bite of the cherry.]

Following service of proceedings, the next stage will be an application to the High Court for permission to bring the judicial review action against NICE. In the circumstances, that hearing might be expedited but, equally, it might be some time before that takes place. Clearly, this will not happen before the roundtable event on 18 October. However, the overriding principle of challenging NICE’s decision remains, even if it later becomes notional rather than real.


Coverage by The Canary

The Canary is an independent online publication committed to campaigning journalism. Steve Topple is a journalist with The Canary who has been following and writing about events in the ME community for some years. He has written a series of articles on the NICE saga. His latest piece can be found at this link NICE will now face court over the ME guidelines debacle.

At Steve’s request, I contributed some comments on the legal process for his article. I’m grateful for his trenchant coverage of this unfolding story. Most of what I said was used but, as I said above, I’m setting it out here in its entirety.

This challenge to NICE’s decision to pause publication of the new guideline for “ME/CFS” is most welcome. Peter Todd of Scott-Moncrieff solicitors has set out a clear, robust case on behalf of the claimant, a child with “ME/CFS” who has experienced harm from treatments recommended by NICE.

The desired outcome of this claim is that NICE follows its own procedure by publishing the new guideline immediately, irrespective of the roundtable event on 18 October. It’s important to remember that this action is a judicial review of the exercise of due process, not a re-examination of the scientific evidence.

NICE has instructed DAC Beachcroft solicitors, the firm which represented the organisation in a judicial review of the 2007 guideline for “CFS/ME”. Their response to this current claim is predictably disingenuous. It is reduced to picking away at individual points in the hope of obscuring the significance of the new guideline which represents a radical shift away from harmful treatment recommendations.

The crux of this case is that NICE has strayed so far outside its own prescribed procedures that it has exceeded its powers, thereby acting unlawfully and/or irrationally.

NICE’s main defence is that it has a wide discretion. This is quite true. Nevertheless, the sentence “[t]he Manual does not expressly provide circumstances justifying a pause in publication of guidelines, but nor does it expressly exclude this possibility” demonstrates a degree of desperation which would be comical if it were not so serious.

NICE is created and governed by statute. It has no power to make up the rules as it goes along.

In Paragraph 14 of the response, NICE concedes three important points:

  1. Because of the large number of comments on the draft guideline (issued in November 2020) NICE postponed its final publication date to 18 August 2021 in order to respond fully and complete all of the pre-publication processes.
  2. Having done that, NICE then released a confidential advance copy to all stakeholders who had commented on the draft.
  3. “Following that confidential release, NICE received a number of communications raising issues with the Guideline from representatives of Royal Colleges and NHS England.” (direct quote from the letter)

Point 3 is a clear admission that, at this stage, NICE allowed itself to be influenced by external interference. NICE is supposedly an independent body. By this stage, such interventions should simply not have been possible.

NICE’s response completely fails to address the central issue raised by the claim. If it intends to publish the new guideline regardless of the outcome of the roundtable, then there is no justifiable reason why full publication has not already taken place.

However, if NICE has not yet published the guideline on the basis that there might be some changes or tweaks as a result of the roundtable event, then this either reopens a process which has already been completed or it begins a whole new consultation and evidence review.

There is no credible justification for those options. If either was to happen, it would confirm that this process is fundamentally and irretrievably flawed.


Finally, because it can’t be said often enough:

“The history of ME remains one of the worst examples of unacknowledged institutional abuse in modern times” ~ Valerie Eliot Smith 2019


6 Comments leave one →
  1. October 12, 2021 02:38

    Thanks you for setting it out clearly – it is unprecedented – I wonder who has what on whom that they thought they could get away with it.

    We, as a community, are fed up. We can’t take the stress. But we are NOT going to disappear!



  1. NICE has “paused” the release of the revised Guideline on ME/CFS | On Eagles Wings
  2. More reactions to NICE – Life with ME by Sissel
  3. Legal challenge to NICE ME/CFS Guideline | WAMES (Working for ME in Wales)
  4. NICE shows transparency, releases documents ahead of 18 October roundtable + a note on parliamentary activity | valerieeliotsmith
  5. 🌍 Much ado about a lot

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