We’ve just learnt that NICE is suggesting that it allows medical technology companies to submit information from clinical trials to the development of NICE’s guidelines, without demanding those companies are complete and transparent about the trial information they have.
National Institute for Healthcare and Excellence (NICE), the UK body that draws up guidelines for the NHS, is requesting feedback on its suggested changes to how it assess interventional medical procedures (ie those that involve incision, puncture and entry into a body cavity, or that use ionising, electromagnetic or acoustic energy).
We have responded to the consultation, here’s what we said:
Section 10.2 sets out the procedure for obtaining information from companies that produce the products used in interventional procedures:
“When NICE is aware that a branded device or devices are used in a procedure, it will make a structured information request to the companies involved at the beginning of the assessment of the procedure. This will normally be done at the time NICE is preparing the brief for the procedure.”
The information NICE requests from these companies includes:
- evidence relevant to the assessment including unpublished trials, trials in progress, registers and post-marketing data
- dates on which trials and other evidence are expected to become available
It further sets out that “NICE invites companies that it has identified in the procedure brief, and that it has approached to request information, to attend the meetings at which the Committee makes its draft recommendations and considers public consultation comments.”
Yet, NICE allows these companies to withhold information about the products. Section 10.2 says that “Companies are not obliged to make this information available to NICE, and are not penalised if they do not do so.”
We urge NICE to:
- Request information about all trials that have been carried out on the procedure by the companies they approach.
- Ask companies to clearly flag up where they are declining to provide complete information.
- Prominently communicate these refusals, where they occur, in NICE outputs.