The Life Sciences sector: a focus on NICE
The National Institute for Health and Clinical Excellence (NICE) is internationally recognised as establishing guidelines for all kinds of treatments and illnesses; it also produces social care and staffing guidelines.
What is the impact of NICE guidance?
Very generally speaking, if you are a patient in England and a treatment you want is recommended by a NICE guideline, you should be able to get it. NHS clinicians look to the NICE guidelines as a benchmark of the best treatment available for patients. Whilst it is not legally binding, the reality is that if clinicians do not follow the guidelines they will have to explain why, particularly if something went wrong.
A recommendation, or not, by NICE can make or break a product’s success in England.
As a public body, a decision by NICE can be challenged by way of judicial review, but you don’t have long to do it.
What can be done if NICE is incorrect?
There is a difference between not agreeing with NICE, and NICE getting it wrong from a legal perspective. For example, its review of the science or health economic benefits may be flawed, or it may have included irrelevant factors or excluded relevant factors in reaching its conclusions. If that is the case, it may be possible to challenge the guidelines through NICE’s internal systems, or alternatively to seek judicial review of NICE’s decision through the English Courts in an attempt to have the guidelines changed. If the situation is urgent, it may also be possible to seek urgent injunctive relief to prevent the guidelines being published.
An application for judicial review can be made to challenge a decision of a public body on relatively limited grounds. Put simply, it is NICE’s process that is challenged (including the factors taken into account in reaching its decision) rather than the merit of the decision itself.
The timelines are short – typically any application has to be made within three months of NICE’s decision. Whether or not judicial review of NICE guidelines will be available is a complex question, and one on which specialist advice should be sought quickly. Given the enormity of the potential effects that unhelpful guidelines could have, it is likely to be a worthwhile investment of both time and money.