• Press Office

    Posted in category News Release by Press Office on 17/09/2003

    WHO Report confirms need for further improvement in NICE, says ABPI

Many of the recommendations of the WHO audit into the National Institute for Clinical Excellence would make NICE a more effective and publicly transparent body, the Association of the British Pharmaceutical Industry (ABPI) said today.


‚ÄčIn particular, the ABPI welcomed the recommendation that NICE should resolve the confusion related to the use of a value-for-money threshold. The ABPI has long argued that NICE's use of a single parameter and threshold is flawed, and the ABPI supports the WHO's call for a review of this area.

"The World Health Organisation's review of NICE is a comprehensive document, and it is disturbing that it has felt that as many as 28 different recommendations need to be made," said Dr Trevor Jones.

"Given that the House of Commons Health Select Committee conducted a major review of NICE just over a year ago, it is unimpressive that so many recommendations for further improvement have been made, covering such basic ground as transparency and contradictory methods of assessment and appraisal.

"Nevertheless, we welcome the fact that the WHO report has confirmed the need for improvement in many aspects of NICE's operations, and we hope that this will result in a constructive dialogue. The pharmaceutical industry is very ready to play its part in looking at the issues raised."

However, while the industry supports the principle of transparency - and indeed is in talks with NICE about how to make information on its products as open as possible - the ABPI stressed that it is likely that there will always be elements of its dossiers that will have to remain commercially confidential.

"During the 10-12 years that it takes to develop a single new medicine, clinical data are generated that will be the subject of publication, but it is not appropriate that they are disclosed prematurely," said Dr Jones.

The ABPI supports the WHO's view that membership of NICE's Appraisal Committee should be based on "skills in and knowledge about evidence appraisal and judgement", but believes that experts from the pharmaceutical industry are uniquely fitted to provide such expertise, particularly in giving a very specific understanding of how medicines are developed.

Conflicts of interest are avoided by making formal declarations of any involvement with a company or medicine under discussion, and experts excluding themselves from discussions where there is likely to be conflict.

The WHO report also called for thought to be given on how to reduce the number of appeals and the length of the appeal process. The ABPI is encouraged that the WHO has examined this area, which it believes still to be flawed as there is no automatic right of appeal, and there is not an adequate separation of the appeals and appraisals processes.

"While there might be sympathy for speeding up the appeal procedure, it is clearly vital that the accuracy of the decision is not impaired," said Dr Jones.

"It is only natural justice that there should be a right of appeal against NICE's decisions, but one way of reducing the number of appeals would be through instituting better and earlier dialogue with interested parties, and this would be welcomed."

For further information, please contact: ABPI Press Office 020 7747 1410

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