Written question asked by Llew Smith (Labour) on Thursday, 20 May 2004, in the House of Commons. It was due for an answer on Monday, 7 June 2004. It was answered by Baroness Winterton of Doncaster (Labour) on Monday, 7 June 2004 on behalf of the Department of Health.

Dept of Health

Question: To ask the Secretary of State for Health, if he will take steps to provide the National Institute for Clinical Excellence with additional powers to ensure negative test results by pharmaceutical companies are published following the report in The Lancet of 24th April; and what mechanisms are in place to ensure that health regulators assessing the safety of drugs for general release are able to make judgements based on unbiased data sets. - Inc refs to 18 May 2004, 421 c995W and 19 May 2004, 421 c1027W.

Answer: Llew Smith: To ask the Secretary of State for Health if he will take steps to provide the National Institute for Clinical Excellence with additional powers to ensure negative test results by pharmaceutical companies are published; and what mechanisms are in place to ensure that health regulators assessing the safety of drugs for general release are able to make judgments based on unbiased data sets. [175780] Ms Rosie Winterton: Regarding the National Institute for Clinical Excellence, I refer my hon. Friend to the reply I gave on 18 May 2004, Official Report, column 995W, to my hon. Friend the Member for West Bromwich, East (Mr. Watson) and the reply given on 19 May 2004, Official Report, column 1027W, by the Under-Secretary of State for Health, the hon. Member for Welwyn Hatfield (Miss Johnson) to the hon. Member for Portsmouth, South (Mr. Hancock). Mechanisms are in place to ensure that health regulators assessing the safety of drugs for general release are able to make judgments based on unbiased data sets. Pharmaceutical legislation specifically requires that all information which is relevant to the evaluation of the medicinal product concerned shall be included in the application, whether favourable or unfavourable to the product.

Secondary information