The duty of the court

NICE procedures were formed to comply with English administrative law. The principles that apply are general: to act lawfully, fairly and rationally. Rawlins notes that ‘the totality of published NICE guidance now totals over 1100 items but only four have been considered at judicial review and the courts have quashed none’.^{Reference Timmins, Rawlins and Appleby2} In fact, as discussed later, the courts have upheld one judicial review challenge on appeal. Nevertheless, Rawlins suggests that this lack of challenge is ‘testimony to the institute's assiduous approach to meeting its legal obligations’. Although this is possible, it is unlikely to be a satisfactory explanation. There are many reasons why judicial review proceedings are not pursued that are unrelated to the legal quality of decision taking. These reasons include lack of awareness that judicial review is available, high costs of litigation and lack of access to appropriate legal advice.^{Reference Bondy and Sunkin3} Of judicial reviews that reach a hearing, around 50% are successful.^{Reference Bondy, Platt and Sunkin4}

The first judicial review concerning NICE was brought by a pharmaceutical company challenging the decision not to recommend their Alzheimer's drug. One basis of this claim was that NICE's decision was irrational. On this, the judge ruled:

Similarly, in a later judicial review concerning recommended treatments for myalgic encephalomyelitis, the judge quoted English case law from 1984:

Therefore, although the legal duty to act rationally may apply in matters of scientific judgement, NICE appears largely free from legal accountability because courts tend to defer to experts; parliament has given NICE authority to decide among the various scientific arguments.

In judicial reviews against NICE, claims have tended to concern specific recommendations, often relating to a single drug. In contrast, during the 2018 stakeholder consultation on the draft depression guideline, 14 professional and patient organisations jointly expressed methodological concerns relating to the way the guideline had been constructed in its entirety.^{Reference Rost and McPherson7} The methodological points raised do not represent commercial interests, indeed – if heeded – they could potentially reduce commercial influence on the guideline. The six methodological points were: long-term trial outcomes should be examined; service-user experience research should be reviewed; quality-of-life outcomes should be taken into account; subcategories of depression should be in line with European and American bodies; partial recovery should be taken into account for severe depression; and network meta-analysis should be abandoned, following the Canadian guideline body, because it is ‘associated with serious and unique risks’ with ‘no formal expert consensus yet established on its appropriateness for this type of review’.^{Reference Rost and McPherson7} In their formal response,⁸ the Guideline Committee stated that none of these points would be addressed in a third revision due for publication in February 2020, largely on the grounds that the Guideline Committee's opinion differs.

In previous judicial reviews, courts have found in favour of NICE where the consultation process has been run in accordance with stated procedures and where NICE has provided a clear rationale for disagreeing with other scientific experts. This suggests that normally, even where differing scientific interpretations of evidence exist in relation to specific trials of specific treatments, NICE is protected from scientific challenge as long as its own stated procedures are followed properly. It remains to be tested whether this would still be the case if a judicial review were brought forward in which the divergent scientific opinions concerned the whole methodological approach and were expressed by a range of non-commercial stakeholders.

In terms of governance, NICE is accountable to the secretary of state and not to parliament directly, although the secretary of state is accountable to parliament.¹ Although 31 parliamentarians wrote jointly to NICE supporting stakeholder concerns about the depression guideline,^{Reference Lamb9} there is no direct imperative for NICE to take this into account. Whereas this may provide an appropriate form of defence from lobbying and commercial interests, in a case in which stakeholders’ concerns are not commercially driven and represent legitimate scientific debate in a controversial field, the principles that might have driven the Dobson–Rawlins pact have the potential to operate perversely.

Sewage works

We now consider the extent to which NICE is accountable from a scientific perspective, irrespective of parliament or the courts. Although never a perfect system since its introduction by English scientific societies in the nineteenth century,^{Reference Csizar10} scientific peer review is regarded as a central component of scientific credibility. One of its early advocates saw it as a way to prevent the ‘veritable sewage thrown into the pure stream of science’.^{Reference Csizar10}

NICE employs stakeholder consultations for this function:

Any organisation may respond as a stakeholder, including pharmaceutical companies and those with financial links to them. The period allowed for consultation (normally 6 weeks) along with timelines for revision and final publication are not long enough for guideline committees to address methodological concerns raised at this stage; with the result that stakeholder consultations tend to manage stakeholder feedback in a superficial manner. There is no imperative for NICE to take on board stakeholder comments and NICE reserves the right not to publish or respond to comments that are too long. Relative to scientific publishing, this form of peer-review process could be described as ‘light touch’, particularly as commercial companies may represent their interests via consultations on a par with any other stakeholder.

There is nevertheless a greater degree of transparency in this process than with other guidelines. For example, the British Association for Psychopharmacology guideline for depression describes a similar process of inviting stakeholders to provide feedback on a draft.^{Reference Cleare, Pariante and Young12} It is also published in a peer-reviewed journal and so presumably had to address reviewer feedback. Yet none of this is transparent in the way that NICE publishes extensive documentation relating to consultations online.

Moreover, because NICE combines its public body ‘duty to consult’ with scientific peer review, further legal duties extend from the consultation exercise. Public consultations are expected to follow a set of principles referred to as the ‘Gunning principles’. The Gunning principles were propounded by Mr Stephen Sedley QC and adopted by Mr Justice Hodgson in R v Brent London Borough Council, ex parte Gunning [1985] 84 LGR 168 at 169; they were subsequently approved by Simon Brown LJ in R v Devon County Council, ex parte Baker [1995] 1 All E.R. 73 at 91g-j; and by the Court of Appeal in R v North and East Devon Health Authority, ex parte Coughlan [2001] QB 213 at [108]. These principles have been understood to include that the public body should ‘have an open mind during a consultation and not already have made the decision’ (e.g. NHS Involvement, 2019).¹³ In arguing that long-term outcomes of trials should be included in the depression guideline analysis, stakeholders noted in May 2018:

The Guideline Committee's formal response in October 2018 stated:

It is possible that a rational mind (in the legal sense) might consider this response to fall short of addressing the specific point about small amounts of good evidence outweighing large amounts of inadequate evidence. It also includes an inaccuracy in that no follow-up data were used in the analysis. The result is that the best possible evidence has potentially been left out of the guideline. Rather than demonstrating an open mind, the Guideline Committee restated their position before the consultation. Similar examples occur in response to each of the six methodological concerns, suggesting that decisions had already been made before consultation. Thus the scale and transparency of the stakeholder consultation exercise could leave NICE open to greater accountability than a closed peer-review process and, in this sense, the means of holding NICE to account scientifically could paradoxically be via its legal duties as a public body.

Court of Appeal

In 2010, as noted earlier, the Court of Appeal quashed a decision by NICE.¹⁴ Evidence concerning a drug's efficacy had been rejected by NICE but accepted by another international body (the European Medicines Agency). Although NICE gave general reasons for their decision, the Court ruled that NICE should have given specific reasons as to why its decision differed from that of the European Medicines Agency.^{Reference Csizar10} This decision draws on a core principle that legally rational decisions should be supported by reasons. NICE recognises this duty in their manual:

The duty to give reasons is normally only applicable in specific cases, e.g. concerning personal liberty, fairness or where a decision appears inexplicable.^{Reference Elliott15} Arguably, this duty exists in the context that concerns us here for a number of reasons, including that the guideline will affect a very large number of individuals with depression and their families, that NICE acknowledge a duty to give reasons in their manual and because the Guideline Committee should explain when their decisions deviate from internationally recognised approaches. Specifically, stakeholders referred to NICE subcategories of treatment-resistant and chronic depression deviating from the ICD and the DSM which group ‘persistent’ forms of depression together; they also referred to reliance on network meta-analysis techniques as deviating from the approach of the Canadian Agency for Drugs and Technologies in Health.