Can you challenge NICE guidelines if they reject your products?
SummarySet up in the UK in 1999 to create consistency across NHS treatment and care, the National Institute for Health and Clinical Excellence (or NICE) now has an international reputation for its guidance (including guidelines) on the management and treatment of illnesses.
- Author Company: Stevens & Bolton LLP’s Life Sciences
- Author Name: Catherine Penny
An introduction to NICE
Set up in the UK in 1999 to create consistency across NHS treatment and care, the National Institute for Health and Clinical Excellence (or NICE) now has an international reputation for its guidance (including guidelines) on the management and treatment of illnesses.
Currently, NICE guidelines are prepared by specifically formed groups, which consider the product or treatment in question, taking into account the views of any interested parties and looking at cost as well as the medical efficacy of the treatment.
To provide some context, if you are in England and you want a treatment that is recommended by a NICE guideline, you should be able to get it. NHS medics look to the NICE guidelines as the applicable standard and, while it is not compulsory to follow NICE guidelines (and in fact they are often not followed), the reality is that if not followed, medics will have to explain why - particularly if something went wrong.
Why NICE guidelines can damage a business
If a product is recommended by a NICE guideline, you can expect that it will be used by NHS England, and possibly more widely, given NICE’s reputation. This is positive if your product is recommended, but can be negative if it is excluded from the guidelines, or disastrous if NICE state that the product is expressly ‘not recommended’.
Of course, NICE’s guidelines can become out of date and it is a significant task to keep them current, but aside from guidelines being current, businesses do suffer if NICE get their guidance wrong.
What can be done if NICE rejects my product?
If NICE rejects your product, it does not necessarily mean that you have grounds for a legal challenge, but it is possible that your product may be excluded by NICE due to an error.
For example, their conclusions on the scientific evidence or the financial considerations may be wrong, or they may not have included all the relevant information in reaching their conclusions. If that is the case, challenge may be possible through NICE’s internal processes, or through the English Court using a process called judicial review to seek a change to the guidelines.
Judicial review is available to challenge a decision of a public body on relatively limited grounds. The timelines are short – with an application usually having to be made within three months of the decision, so swift legal advice is important.
Once advice has been taken, the first step is to approach NICE to tell them about the planned application to give them the opportunity to respond and, in some cases, accept that they have made a mistake and agree to adjust the guidelines.
If that approach does not work, the application will need to be issued, the Court fee paid and the Court process will then follow. NICE and any interested parties will be given the opportunity to respond formally. In judicial review cases, unlike general commercial litigation cases, the Court carries out an initial review to decide whether the case can proceed. The process as a whole can take many months and can be expensive, so it will be an important decision for any business to make.
Whether a judicial review of NICE guidelines is the best step for business is a complex question, and one that shouldn’t be taken lightly. Specialist advice should be sought quickly to ascertain all the options and so that the business can best position itself for next steps. However, given the potential long-term effect of incorrect guidance, it is likely to be an investment worth pursuing.