Guidelines on what company data should be made public during a NICE health technology appraisal have been agreed between the National Institute for Clinical Excellence and the Association of the British Pharmaceutical Industry.
The agreed guidelines recognise the importance to both patients and to the quality of the NICE appraisal process of putting relevant information into the public domain to ensure the credibility, clarity and comprehensiveness of their guidance, while also acknowledging that the rights of owners of data should be respected. They set out principles and practical examples of what data should be made public and when.
Reviews of NICE by both the World Health Organisation and the House of Commons Health Select Committee have highlighted the need to limit confidentiality constraints on information supplied to NICE for technology appraisals.
"This is a welcome agreement for both the industry and NICE," said Vincent Lawton, President of the ABPI. "It reflects the accepted trend towards transparency, embodies industry effort to minimise what is labelled confidential, but also respects the industry's legitimate right to maintain confidentiality where absolutely necessary."
Andrew Dillon, chief executive of NICE, said: "These guidelines are helpful in achieving consistency of approach by companies now, and they are step towards our long term goal of achieving unrestricted access to all relevant data."
NICE's new technology appraisal process and methods of technology appraisal documents now incorporate these guidelines.