LONDON The UK's National Institute for Clinical Excellence has opted to remove confidentiality from its technology appraisal process as a means of pre-empting information leaks. The decision was made at a public meeting of the NICE board on 15 November 2000.
NICE was set up in 1999 to examine drugs and advise the UK National Health Service (NHS) on the use of different products. In the past year there has been much controversy over NICE's verdicts, aided and abetted by information on preliminary proposals being leaked to the public.
Until now, NICE's policy has been to maintain confidentiality of information during its four-week consultation process. The only people supposed to have access to 'provisional determinations' are the national organisations who contributed to the appraisal and members of the institute. But in some cases there have been more than 50 consultees and NICE has been unable to prevent leaks of information. The institute's chairman Professor Sir Michael Rawlins says: "Whilst NICE can guarantee the integrity of its own processes, we can't control what others might do therefore confidential documents have been regularly leaked."
In July a serious leak took place during the appraisal of the anti-cancer treatment taxane, and the institute employed management consultants Deloitte & Touche to conduct an investigation. In the light of the consultants' recommendations, a review of NICE's effectiveness was scheduled for November.
NICE's reason for introducing confidentiality in the first instance was to ease the concerns of its key stakeholders, the healthcare industries. First, they feared that provisional decisions might upset patients unnecessarily, as the opinion of the institute could later change. Second, early deliberation by NICE was seen by stakeholders as share-price sensitive and therefore had the potential to destabilise the stock markets.
Given the leaks of information during the appraisals of taxane, the anti-flu agent Relenza and beta interferon, it's clear NICE can no longer offer confidentiality. Indeed, the paper submitted to the board by Professor Rawlins states that "the leak of the content of provisional and final appraisal determinations has unquestionably damaged the Institute's image."
Professor Rawlins explains how leaked information is partial and does not include the reasoning behind provisional advice. Such leaks only serve to create a false market for shares and NICE believes it could be subject to severe criticism if significant share price movements result from flaws in its 'confidential' process.
The board voted unanimously to adopt a more transparent approach to its appraisals by publishing its provisional and final determinations on its website. "It was clear to the board that the current position regarding confidentiality is unsustainable," says Professor Rawlins.
NICE must now consult its stakeholders and the Financial Services Authority before instigating a new approach. The board will review the matter in its January meeting and until then the existing arrangements will continue.