When NICE guidance is more than just guidance - The duty on CCGs following R (Elizabeth Rose) v Thanet Clinical Commissioning Group

17 April 2014

In Rose the Administrative Court considered whether a Clinical Commissioning Group (CCG) had acted unlawfully in failing to follow guidance issued by the National Institute for Health and Care Excellence (NICE), even though it was under no statutory duty to do so.

The court found that, even in the absence of any statutory duty, CCGs can choose not to follow NICE guidance only where there is some special factor which exceptionally justifies them in doing so. Merely disagreeing with the guidance is not enough.

Background

The claimant, Elizabeth Rose, was a 25 year old woman who has suffered from a severe form of Crohn's disease since she was 14. Her condition had deteriorated and her doctors recommended bone marrow transplantation and chemotherapy to hopefully bring the disease into remission. Infertility and the early onset of the menopause are probable outcomes of such treatment.

The claimant therefore wished to secure the best chance of having her own genetic children, and sought NHS funding for oocyte cryopreservation (the Procedure) before beginning chemotherapy. The cost of the Procedure is £4050 and, as the claimant was in receipt of benefits and could not afford this sum, she applied to the defendant Clinical Commissioning Group (CCG) in May 2013 for funding.

The CCG's policy, which had been carried over from an earlier policy of its predecessor Primary Care Trust (PCT), was not to grant funding for the Procedure unless the applicant has any exceptional clinical circumstances. The CCG considered that the claimant's circumstances were broadly in line with the group of similar patients addressed by the policy and that no exceptionality had been established. Funding was therefore refused in June 2013. Although the claimant did not have a right of appeal against this decision, the matter was reconsidered and the refusal upheld in July 2013.

The National Institute for Health and Care Excellence (NICE) is the national body responsible for providing guidance on promoting good health and social care services. In February 2013 NICE published guidance (NICE Guidance GC156 – the Guidance) which recommended that the Procedure be funded. A similar recommendation had been made in guidance issued by NICE in 2004.

Under the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 (the NICE Regulations), NICE has the power to make two different types of recommendations with which CCGs must comply. These are known as technology appraisal recommendations and specialised technology appraisal recommendations (regulations 7 and 8 respectively). In this respect the NICE Regulations mirror directions given by the Secretary of State to PCTs in 2002 to fund such recommendations.

However, the Guidance wasn't one of these types of recommendation. Rather, it was issued under a general power in the NICE Regulations for NICE to give advice or guidance, or to provide information or make recommendations, about any matter which relates to its core activity (regulation 5).

The NICE Regulations say nothing about any duty on CCGs to comply with this type of guidance. On its face, such guidance is therefore non-binding.

In October 2013 the CCG adopted a new policy to run from April 2014 which, despite the Guidance, posited that the Procedure should be refused save in exceptional circumstances (the Policy). That decision was taken on the basis of a report by the Kent and Medway Commissioning Support Unit which stated that existing clinical evidence was insufficient to support funding the Procedure (the Report).

The challenge

The claimant sought judicial review on a number of grounds which called into question both the decision not to provide funding in her case and, at a broader level, the Policy.

She attacked the refusal of funding on several grounds:

  • the decision constituted direct discrimination (on the basis that funding for semen cryopreservation was provided to men in similar circumstances),
  • it was a breach of the defendant's public sector equality duty under section 149 of the Equality Act 2010, and
  • it breached her rights under articles 8 and 14 of the European Convention on Human Rights (and therefore section 6 of the Human Rights Act 1998).

These arguments were unsuccessful, as was an argument that the Policy was unlawful because, in practice, it constituted a blanket policy which admitted no exceptions.

However, the judge, Mr Justice Jay, did find that the CCG's decision to establish a Policy which was inconsistent with the Guidance was unlawful. This part of the judgment is important.

The decision

The CCG's obligation under the NHS Constitution was to make rational funding decisions grounded on a proper appraisal of the evidence base. Both parties accepted that the Guidance fell within that class of NICE recommendation with which the CCG was not under a statutory obligation to comply.

However, although the NICE Regulations do not state that CCGs should even have regard to guidance issued by NICE under regulation 5, its legal obligations did not stop there. It was under an obligation in public law to have regard to the Guidance and to provide clear reasons for any general policy that did not follow it.

The issue in this case was whether CCGs may legitimately disagree with NICE on matters concerning the current state of medical science. It was NICE's view that the evidence base supported the effectiveness of the Procedure, and the CCG's sole basis for not following NICE's recommendation was that it disagreed.

Previous case law from 1997 (R v North Derbyshire Health Authority, ex parte Fisher) had found that a decision not to follow national policy in the form of guidance from the Secretary of State was only lawful if there was some 'special factor' which 'exceptionally justified departure'. Disagreement with the policy was not enough. The court applied this judgment to the present case and found that no basis or reasoning on grounds of exceptionality was put forward by the CCG.

The judge pointed out that the CCG could have found other reasons, on the basis of exceptionality, for not following the Guidance (although neither he, nor the judge in Fisher gave examples of what those reasons could be). It had not done so and mere disagreement was insufficient. The Policy was therefore unlawful.

The alternative basis

Jay J indicated that even if Fisher had been distinguishable from the present case, he would in all the circumstances have reached the same conclusion. On normal public law grounds, the CCG had not advanced a valid reason for disagreeing with the Guidance and so the Policy wasn't a rational decision.

The problem for the CCG was that the Report had dismissed the Guidance in three sentences which stated that:

  1. clinical evidence in support of the Procedure was lacking,
  2. the success rates from those studies which were available were likely to be inflated, and
  3. the Procedure would be undertaken in those studies at clinics which had considerable experience undertaking that technique.

The judge found that the CCG had failed fully to grapple with the clinical evidence that underlay the Guidance and the fact that it was described by NICE as a 'strong' recommendation. The latter characterisation reflected the strength of evidence which underlay the recommendation and was a change from the 2004 guidance. The 2004 guidance recommended that patients be warned that the chances of a successful outcome in using the Procedure were poor, a recommendation dropped in the Guidance.

In this case, therefore, the CCG had not only failed to demonstrate that there were exceptional reasons for departing from the Guidance, but had also failed to advance any clear and lawful reasons for doing so. It did not meet even a minimal public law threshold for decision-making.

The judge's finding that the Policy was unlawful did not assist the claimant as the Policy was not in place when the decision in her case was made and she had not challenged its predecessor. He did not therefore quash the refusal of funding. Nor did the judge quash the Policy itself, but he did indicate that the CCG should consider the ramifications of his conclusions in regard to it.

Commentary

The decision in Rose is an important one. It applies the relatively old decision in Fisher, which concerned guidance issued by the Secretary of State to PCTs, to the question of whether and when CCGs may depart from NICE guidance.

It makes clear the court's view that, in the absence of special factors which exceptionally justify departure for such guidance, the default position is that CCGs should follow it, even where there is no statutory obligation to do so. Disagreement with NICE guidance is not a valid reason for refusing to follow it.

This means that even if guidance issued by NICE does not fall with regulations 7 and 8 of the NICE Regulations, and does not therefore carry a statutory obligation on CCGs to follow it, the court has held that there is a duty on CCGs in public law which has a similar effect.

This finding may come as a surprise to CCGs as it could not be anticipated from a bare reading of regulation 5 of the NICE Regulations, which is silent on the way in which guidance issued under that regulation must be dealt with.

Likewise, CCGs may also be surprised by the way in which the Court has chosen to give effect to the public law duty 'to have regard' to NICE guidance. Usually such duties are characterised as relatively weak or 'light touch'; a CCG must turn its mind to and properly consider whatever it is to which it must have regard, but this does not limit the decision which it may then take.

However in this case, by applying Fisher, the court has found that a CCG is obliged to comply with NICE guidance unless some exceptional circumstance applies. Like Fisher before it, the judgment in this case has the effect of elevating a certain type of guidance to a status in which it appears to trump almost all other considerations; effectively, a super 'have regard to' duty.

It is questionable whether the Secretary of State intended guidance under regulation 5 to have such weight. Firstly, the NICE Regulations are silent on the matter of how CCGs should treat such guidance, whereas they make clear that other types of recommendations must be complied with.

Secondly, it is notable that there is a right of appeal to a semi-independent panel under the NICE Regulations against the two types of recommendations which CCGs are obliged to follow. This is unsurprising as, in circumstances where NICE recommendations are given the force of directions, they have important consequences and should therefore be capable of appeal. If regulation 5 guidance was intended to have the weight which the court has given it, it is likely that it too would have been made capable of appeal.

It is not known at present whether either party in Rose will seek to appeal the decision to the Court of Appeal. If an appeal does proceed, it may be that the finding regarding the applicability of Fisher is overturned. If so, Jay J's alternative line of reasoning will need to be considered.

That line of reasoning is firmly grounded in the application of well-established public law concepts with which the Court of Appeal may find it harder to disagree. NICE guidance under regulation 5 is a relevant consideration which a CCG must have regard to in its decision-making, and in this case the paucity of the CCG's rationale in the Report was particularly stark and rendered its decision to depart from the Guidance irrational.

If a CCG disagrees with a NICE recommendation on scientific medical grounds, it must at least do so on the basis of a fully reasoned consideration of the clinical evidence. For the time being, as the judgment in Rose stands, even that will not be sufficient, and exceptional circumstances will need to be identified.

Most public bodies will be under a variety of 'have regard to' duties both in statute and in public law. One of the wider implications of this case is that such bodies should carefully consider the weight which they should attach to any guidance, or similar publication, to which they must have regard. The duty may not, in all circumstances, require only a 'light touch' approach.


NOT LEGAL ADVICE. Information made available on this website in any form is for information purposes only. It is not, and should not be taken as, legal advice. You should not rely on, or take or fail to take any action based upon this information. Never disregard professional legal advice or delay in seeking legal advice because of something you have read on this website. Gowling WLG professionals will be pleased to discuss resolutions to specific legal concerns you may have.