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In their article McPherson and Speed claim that NICE’s independence seems to have diminished over time, and that it has been significantly undermined during the COVID-19 pandemic. They attempt to explain how various soft political factors may operate and how they undermine NICE’s scientific integrity.
The authors begin by suggesting that NICE’s re-establishment as a non-departmental public body (NDPB) in 2013 was prompted by the need to “increase the deniability of rationing claims or for other political purposes”.
Rather surprisingly, the authors then go on to claim that:
“This revision to the relationship can be regarded as a move towards a more explicit form of meta-governance, whereby government mechanisms are enacted through a range of quasi-autonomous bureaucratic devices.”
and further that:
“decisions about access to healthcare, for example, can be made remotely from ministers and political motive obscured by claims of the need for availability to be determined by science, not politics."
These statements are baffling because the legal position is clear. As a statutory corporation NICE is more, rather than less, independent as an arms length body (ALB) and as a body subject to administrative law and the administrative court, NICE is positively required as a matter of law to reach its decisions independently. If it did not do so its decision would be subject to being overturned by the courts. Furthermore, the regulations...
These statements are baffling because the legal position is clear. As a statutory corporation NICE is more, rather than less, independent as an arms length body (ALB) and as a body subject to administrative law and the administrative court, NICE is positively required as a matter of law to reach its decisions independently. If it did not do so its decision would be subject to being overturned by the courts. Furthermore, the regulations governing NICE specifically prevent the Secretary of State from directing NICE as to the content of its recommendations and any such purported direction would be a legal nullity. NICE’s reestablishment as an NDPB rather than a special health authority increased its independence because now any change to its powers or governance can only be made by Parliament, whereas as a special health authority such changes could be made by ministers alone.
We would like to comment on the two main key messages of the article.
The first is the assertion that the NICE processes for developing rapid guidelines for COVID-19 reveals that “the explicit removal of some or all scientific checks and balances in an emergency situation suggests that the central reliance of NICE on claims to scientific legitimacy is not in fact central at all. Rather, it is the first feature to be removed in the interests of expediency as though scientific processes were unnecessary bureaucracy.”
The authors suggest that political drivers could now, without any new legal agreement, prior discussion in parliament or amendment to the Framework Agreement, directly influence the scope and content of rapid guidelines. This suggestion makes very little sense since, other than topic selection there is no way in which a “political” driver could impact on any of NICE’s work.
In relation to the rapid guidelines, we remained independent from government. The guidelines were developed at the request of NHS England and NHS Improvement in response to the COVID-19 pandemic, a level 4 national emergency. Normally a topic selection oversight group at NICE considers topics for guideline development, taking into account a range of factors such as:
1. Whether there is existing NICE-accredited guidance on which to base a quality standard that encompasses the whole of the topic
2. The priority given to the topic by commissioners and professional organisations, and organisations for people using services, their families and carers
3. The health and care burden, and the potential to improve outcomes and quality of life
NICE then discusses topics identified in this way with NHS England, the Department of Health and Social Care, and Public Health England, and a prioritised list is agreed by these 3 bodies.
On 17 March 2021, we moved our priorities for the first wave of the pandemic to publish only those guidelines that were therapeutically critical and/or addressed COVID-19 diagnostic or therapeutic interventions. We worked with NHS England and NHS Improvement to identify topics to support managing symptoms of COVID-19, managing conditions that increased risk, or providing services during the pandemic. We developed interim process and methods that retained the core elements of scoping, evidence search and retrieval, working with experts, consultation, equality impact assessment and quality assurance. Inevitably, because of the urgency with which the guidance was required by the system, the process was rapid.
It is not an erosion of scientific or political independence to take into account a range of different views, including those of NHS England, especially in a national emergency. If we had used our normal process and methods for example by including a 4-week consultation period, we would have missed the optimum time identified by clinicians and commissioners for the guidance to be most useful to those managing pandemic. We achieved an optimal balance of speed and engagement for consultation, with a significant volume of comments received from a wide range of organisations.
Because COVID-19 is a new disease, evidence and practice are developing rapidly and we have implemented a process to keep the guidelines up to date as new evidence emerges. The guidelines have been very well received by clinicians and commissioners and our rapid response widely praised.
The second key message of the article is that “NICE cannot be truly led by science, in part because of its relationship to the state, however obscure that relationship has been made.”
NICE is not, and never has been, a ‘scientific authority’. Indeed, and as the authors acknowledge, in 2005, NICE published a guide setting out the social and scientific value judgements that informed our approach to developing guidance. The Social Value Judgements document helped our advisory committees resolve uncertainty in the available evidence. It informed their judgements when developing guidance, by giving them a set of principles. The Social Value Judgements were originally designed to support decision-making in guidance on new technologies. NICE’s remit has grown significantly since then. We now produce a wide range of guidance for different audiences, including local government and social care providers, which draws on a wider range of evidence. The original Social Value Judgements document remains relevant to our work, and much of what it contains is included in our methods and process manuals. In 2019 we replaced our Social Value Judgement document with a statement of our principles. This focuses on the key principles that are universal to all our guidance and standards and explains the morals, ethics and values that underpin our recommendations.
We were always clear that we would create recommendations for the system based on the evidence, but also taking into account a range of different morals, ethics and values from patients, clinicians, commissioners and other users of our guidance. Our independent advisory groups are expected to use our principles, along with our methods and process guides and the NICE charter, to inform their decisions.
One of the principles is the use of independent advisory committees to develop recommendations. This is to ensure that our recommendations are unbiased and objective and relevant for the wide range of people affected by our guidance.
We have a rigorous approach to managing conflicts of interest, with a policy that is world-leading in its standards. Committees include people from the NHS, commissioners and providers of social care, local authorities, academia, relevant industries, organisations that represent people who use services and carers, and the general public.
We also require committees to take into account stakeholder comments submitted during open consultation, and I would argue that this is a more robust, reliable and transparent method of ensuring quality and relevance than any process of traditional peer review – in fact quite the opposite of ‘light touch’. We publish both the comments we review and the responses to those comments.
In summary, NICE is an independent body that balances science, expertise and social and moral values to produce guidance informed by the best available evidence. We had to adapt and respond to an unprecedented set of circumstances in developing and maintaining guidance on COVID-19. Perhaps the authors might more usefully have addressed the question as to what else we should have done in response to a pandemic? We would argue that retaining our existing processes and topics without regard to the urgency of the situation would have been a manifestly worse position.