The Association of British Healthcare Industries (ABHI) has always sought to be a supportive partner to NICE and these comments are intended to be constructive in the manner of open and transparent feedback, rather than negative criticism.

Why NICE's Decisions are Increasingly Being Challenged

  The perceived increase in challenges to NICE decisions may have a direct correlation to the volume of guidance currently being produced by NICE. NICE has increased the volume of guidance published with the introduction of the STA process. There is now a reduction in the time taken to complete an appraisal and an increase in the quantity completed. One could argue that there is not sufficient time available during the STA process for an adequate consultation so some stakeholders may feel that their issues are not being addressed during the process and would therefore be minded to challenge the final decision.

Whether Public Confidence in the Institute is Waning, and if so Why

  The ABHI is not able to confirm this one way or another but would speculate that the publicity surrounding each challenge may have a negative effect on the public perception of NICE as an organisation especially when there are headlines indicating a particular patient group is disadvantaged by the restriction of a technology.

NICE's Evaluation Process, and Whether any Particular Groups are Disadvantaged by the Process

  As indicated above under the newly introduced STA process, the time constraint does not allow sufficient opportunity for stakeholders to adequately address issues that may develop during the process.

  We feel that in general, manufacturers are at a disadvantage because of their absence at appraisal committee meetings. The inability of manufacturers to address issues that may have come up during review is a major flaw in the system.

  Whilst it is recognised that NICE appraisal managers would not want to be constantly bombarded by parties with particular interests it would be beneficial to have an ongoing dialogue throughout an appraisal rather than just at the beginning of the process. Therefore the "consultee workshop" should incorporate the ongoing dialogue.

The Speed of Publishing Guidance

  NICE has made many moves to reduce the timing for the development and publication of its guidances. However under the STA process, stakeholder involvement and consultation has been reduced which has the potential to lead to less robust decisions.

The Appeal System

  Under the STA, the opportunity for stakeholders to comment on the academic group report has been removed. We would strongly suggest some form of interaction following this report will give stakeholders the confidence that they have some form of recourse.

Comparison with the Work of the Scottish Intercollegiate Guidelines Network (SIGN)

  Our knowledge of the work undertaking by SIGN is limited. We do know that SIGN will look at a NICE appraisal to see how this might fit within the Scottish environment. This process is usually shorter than the NICE process.

The Implementation of NICE Guidance, Both Technology Appraisals and Clinical Guidelines (Which Guidance is Acted on, Which is Not and the Reasons for This)

  The value of the appraisal process would be enhanced if there were more robust methods for ensuring that guidelines were subsequently adhered to post-publication. We believe that specific recommendations and targets would help.

  We would also like to make mention of the budget implications following a technology appraisal. Technologies are allocated mandatory funding. However when a technology appraisal is incorporated into a guideline this reference to mandatory funding is removed and we believe that there should be an ongoing obligation to monitor the funding of this technology especially in cases where there is a risk of the guideline not being implemented effectively.

John Wilkinson

Director General, Association of British Healthcare Industries

March 2007