NICE strikes deal with industry on data confidentiality
pharmafile | May 19, 2004 | News story | |
The industry and NICE have reached agreement on how the cost and clinical effectiveness body can meet demands for transparency while preserving confidentiality of commercially sensitive product data.
Data confidentiality and NICE has been a sensitive issue for the industry since the body was set up in 1999, but a number of reports have urged both sides to resolve their differences.
Leading a WHO review of NICE in September 2003, Kees de Joncheere said: "To gain access to key information, NICE also accepts material designated as confidential. In the main, this comes from the pharmaceutical industry. While we welcome the steps they have taken to push these boundaries with the industry, NICE should reconcile this inherent contradiction."
Finalised after months of discussion, the industry has made concessions to publishing more data but has been able to maintain confidentiality by signing up to a number of agreements, and retains the right to make the final decision on the release of information.
The ABPI and NICE have agreed on core principles on the release of company data into the public domain, including NICE recognising the rights of companies as well as the interests of patients and consultees, and its commitment not to release information provided to it before a product's release.
NICE's technology appraisals are being launched increasingly early in a product's life, and in some cases is beginning work before the drug is licensed in the UK. One of the most high-profile examples of this is AstraZeneca's Exanta (ximelagatran) – the drug is not expected to be approved in the UK until late 2004, but has been on NICE's appraisal list since October last year.
Two simultaneous appraisals of its cost and clinical effectiveness – one for venous thromboembolism and one for stroke prevention are scheduled for publication in February 2006.
The agreement anticipates some circumstances where NICE will want to publish data regarded by the owner as confidential, and says the parties will negotiate in good faith to "find a mutually acceptable solution, recognising the need for NICE to support its recommendations with evidence and the data owner's right to determine a global publication strategy."
President of the ABPI Vincent Lawton commented: "This is a welcome agreement for both the industry and NICE. 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 the guidelines were helpful in achieving consistency across the industry. In a clear sign that NICE see the agreement as the beginning and not the end of moves towards greater transparency, Mr Dillon added that the guidelines were a "step towards our long-term goal of achieving unrestricted access to all relevant data."
