How NICE manages potential conflicts of interests of patient experts

NICE’s independent technology appraisal and highly specialised technologies committees produce guidance on the use of new medicines in the NHS. Their work is greatly enhanced by the voices of people who use services, carers, and the public and help to ensure our work is anchored in real life.

These independent committees make recommendations based on careful analysis of all the evidence in support of the medicine’s clinical and cost effectiveness, to determine whether the medicine provides value for money to the NHS.

The nature of NICE’s role in the health system means that we frequently experience pressure from across the health ecosystem and from a multitude of stakeholders. As a result, over more than two decades NICE has developed robust processes to ensure we can provide rigorous and independent assessments of complex evidence for new health technologies. This includes our policy for declaring and managing the interests of all those who participate in NICE’s advisory committees. The policy requires all relevant financial and non-financial interests that a person - and the organisation nominating them – has, to be declared such that these can be reviewed by NICE. A direct interest is any where there is, or could be perceived to be, an opportunity for a person involved with NICE’s work to benefit.

Patient groups will need to declare payments they have received from manufacturers. We recognise that these payments are made, and our committees are aware that both patient groups and their representative charities give their insights from their own perspective and interests. Having a declared interest does not necessarily mean the person or organisation are conflicted.

Our focus is on understanding the interests these patient experts may have, which is important context to the statements they might make in committee meetings.

Although patient experts play a key role in the appraisals process, they are not decision makers. Ultimately, our appraisal committee members will decide whether a medicine provides value for money to the NHS and should be recommended by NICE, informed by the evidence available to them. Our policy therefore outlines the robust risk-based approach for managing committee members’ potential conflicts of interests and will usually exclude them from the meeting if they have a direct financial interest.

NICE also allows the manufacturer of the medicine to participate in the committee meeting, to correct factual inaccuracies and to answer questions that committee members might have about the evidence supporting the medicine.

Implementing stricter requirements for patient experts than pharmaceutical companies – who are assumed to have a direct financial interest - for participating in committee meetings would be disproportionate to the role patient experts have in committee meetings.

NICE regularly reviews its policy on managing and declaring interests. For example, it was amended in response to a study on patient group funding from industry, and now requires experts who are nominated by an organisation to declare funding received by that organisation from the manufacturer of the medicine under review.

We have also considered whether we should extend the timeframe for declaring interests that are no longer relevant beyond the current 12-month requirement. However, if a financial interest has ceased to be relevant to the appraisal and ceased to be a relevant interest more than 12 months ago, it is unlikely that, if declared, it would result in a decision to exclude the person from participating in the meeting. On balance, it would increase the administrative burden for experts without making a meaningful change to the assessment of whether the interests prevent partaking in the committee meeting or not.

Decisions on managing interests must balance the need for advisory committees to have access to the appropriate expertise on the areas under consideration, while minimising the risks to their perceived ability to objectively consider the evidence.

The reality is that many patient organisations have financial ties to the life sciences industry, and initiatives such as Disclosure UK have increased the transparency of financial payments made to patient organisations in recent years, which is a welcome development that supports the ability of our committee members to be aware of the conflicts experts might have and enables a robust, risk based approach for managing potential conflicts of all those who participate in committee meetings.

NICE values the contribution patient groups make to its work and will continue to ensure their voices are heard.