Access To Clinical Trial Information And The Stockpiling Of Tamiflu

Download or read book Access to clinical trial information and the stockpiling of Tamiflu written by Great Britain: National Audit Office and published by Stationery Office. This book was released on 2013-05-21 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: This review reports whether medicines regulators and NICE have access to the clinical trials evidence they require when licensing Tamiflu and other medicines for use in the NHS, and whether the Department of Health stockpiled Tamiflu for influenza pandemics on the basis of clinical evidence. The NAO has set out a number of recommendations: (i) NICE and the MHRA should work together, with the EMA where necessary, to ensure that arrangements are in place to allow NICE to access the evidence underlying regulatory decisions to avoid the necessity for duplicated effort by NICE; (ii) NICE should require manufacturers to give assurances that they have confirmed at a global level that the evidence submitted is complete; (iii) NICE should align its policies for the publication of information across single and multiple technology appraisals of medicines or treatments; (iv) When making decisions about the stockpiling of pandemic medicines, the Department and its agencies should concentrate on building up knowledge about the added value of stockpiling through reducing complications and deaths; (v) To reduce the risk of unnecessary write-offs, NHS England and Public Health England should ensure that all providers of antivirals in a pandemic have robust antiviral storage and quality control in place during a pandemic; (vi) The Department should review its guidance and methods for ensuring that those in need of Tamiflu receive it quickly enough for it to be of use.