Legal challenge to NICE ‘pause in publication’


On the 1st October a legal action was launched against NICE, claiming the failure to publish the final guideline for ME/CFS was unlawful – that NICE failed to follow it’s own rules – and it should be published by Wed 6 October.

When NICE failed to publish, instead insisting they would aim to make a decision following the 18 October Roundtable discussion, the legal team obtained legal aid to begin the process of applying to take NICE to a Judicial Review.

Who is behind the legal action?

A child diagnosed with post-viral CFS/ME in December 2013 ‘was given treatments according to the current NICE guidelines: CBT where he was instructed not to talk about his symptoms but just push through them and Graded Exercise Therapy [GET] which was a continual gradual increase in activity, regardless of the state he was in. This treatment caused him significant harm… [his] post-exertional malaise [PEM] was ignored… [He] is worried that if he seeks treatment from the NHS he will be further subject to the harmful regimen specified in the NHS by the current NICE guidance.’

The 2021 unpublished  guideline no longer recommends the treatments many say has harmed them, so that is not the focus of the legal action.

Barrister Valerie Elliot Smith says:

“It’s important to remember that this action is concerned with a judicial review of due process, not of the scientific evidence.”

Why is NICE accused of acting unlawfully?

The accusation is based on two principles:

1. Procedural impropriety

“NICE has adopted its manual of methods and procedures for developing its guidelines. It has followed those procedures scrupulously to this point. However, NICE has broken out of its prescribed procedures and now intends to repudiate its procedures and engage in politics. This is a fundamental betrayal of NICE’s constitutional role and prescribed methods. The Claimant intends to ask the court to intervene to prevent this unlawful use of NICE’s powers.”

2. Irrationality

“… In this case it is contended that NICE have acted irrationally in that they have ceased to have regard to scientific evidence, but instead are being materially influenced by irrelevant factors such as whether those who may have commercial interests need to be persuaded to support a change which will adversely affect those interests.”

NICE’s defence

NICE’s lawyers replied late on Wed 6th October to deny the claims because:

  • they have wide discretion
  • ‘NICE guidelines are not binding. They inform the judgement of bodies providing NHS services and their clinicians, nothing more.’
  • ‘The Manual does not expressly provide circumstances justifying a pause in publication of guidelines, but nor does it expressly exclude this possibility’
  • ‘the express purpose of the meeting is to gain support for the Guideline’.

The Lawyers fail to explain why it was necessary to pause publication if all they intend to do is to gather support for the guideline. The unanswered question is whether they are open to making changes before finally publishing. The ME community knows the guideline is not perfect but believes it is a more ‘evidence based’ document than the 2007 guideline. The Royal Colleges and NHS England have said they want some reversal to the treatment recommendations so they can continue to deliver controversial treatments to people with ME.

Should the UK Government intervene?

Steve Topple, in his online article in ‘the Canary’ says the government could intervene if an MP raises the issue formally via an “urgent question” in parliament because:

  • Under the Health and Social Care Act 2012. NICE has an agreement with the Department of Health and Social Care (DHSC) its work is commissioned by ministers or by NHS England several years in advance and the development of individual pieces of guidance can take between 6 months to 2 years.
  • the DHSC secretary of state (currently Sajid Javid) is “accountable to parliament” for NICE and its “performance”. And the DHSC permanent secretary (currently Chris Wormals is responsible for making sure “arrangements are in place” to address significant problems and bring concerns about the activities of NICE to the DHSC board and give assurances that appropriate action has been taken.

Next steps:

Lawyer Peter Todd is preparing papers to file and serve proceedings in the High Court after the Round Table discussion.  Ian Wise QC is being instructed to settle the statement of facts and grounds. 

More information:

Letter before action to NICE

Letter of response from NICE legal team

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

Steve Topple: NICE will now face court over the ME guidelines debacle, in the Canary

See also

NICE publishes ME/CFS guideline: evidence says GET & CBT cannot cure!

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