Access to clinical trial information and the stockpiling of Tamiflu - Public Accounts Committee Contents

2  Stockpiling Tamiflu and the management of the stockpile

7.  The number one risk on the Government's national risk-assessment for civil emergencies, ahead of both coastal flooding and a major terrorist incident, is the risk of pandemic influenza. Antiviral medicines contain an active substance which interferes with the influenza virus, stopping it from spreading. Between 2006-07 and 2012-13, the Department spent £560 million on antiviral medicines for use in an influenza pandemic - £424 million on Tamiflu and £136 million on Relenza. Just under 40 million units of Tamiflu were purchased.[19]

8.  The MHRA is confident that it, and other European regulators, received all relevant information during the licensing process for Tamiflu.[20] However, this was questioned in a written submission following the hearing by the Cochrane Collaboration, an international network that undertakes systematic reviews of primary research in healthcare and health policy. The NHS National Institute for Health Research had funded the Cochrane Collaboration to conduct a review of the effectiveness of Tamiflu. Having first requested complete reports of each clinical trial on Tamiflu in 2009, the Cochrane Collaboration team is now receiving full clinical study reports from Roche, the manufacturer of Tamiflu, which will allow it to complete its review on the efficacy of Tamiflu.[21]

9.  There is a broad consensus that Tamiflu reduces the duration of influenza symptoms and also reasonable consensus on its ability to prevent illness, in some situations. However, there is a lack of consensus over the efficacy of Tamiflu to reduce influenza complications, including pneumonia, and to reduce mortality.[22] Clinical trials for Tamiflu were undertaken on people suffering from seasonal influenza. Complications and death are rare outcomes in a seasonal influenza outbreak, making it difficult for these clinical trials to establish efficacy over these outcomes. Pandemic influenza can be much more severe, as demonstrated by the 1918 pandemic, meaning judgement needs to be used about Tamiflu's efficacy during a pandemic.[23]

10.  During 2008, the Department developed a business case to establish a stockpile of antivirals and pre-influenza pandemic vaccine. The business case included increasing antiviral medicines to 80% population coverage in a two-stage process. Despite there being only limited evidence and widespread disagreement among regulators and other bodies internationally on whether Tamiflu confers any benefits on complications and mortality, the Department used an assumption of a 40% to 50% reduction in complications and mortality in its case to increase the antiviral stockpile to 80% population coverage.[24] The assumption was based on the modelling of previous pandemics and followed advice from a range of experts including the Department's Scientific Pandemic Influenza Advisory Committee.[25] The business case also showed, under an alternative scenario, only minimal additional benefits from increasing the stockpile from 25% to 50% population coverage. This was due to assumptions in the modelling that the most at-risk groups would be targeted first.[26]

11.  We asked the Department why it had written off 6.5 million units of Tamiflu at a cost of £74 million. The Department explained that these medicines had been distributed to many places around the country at the time of the 2009 pandemic. When unused stocks were returned, it was not clear whether they had been stored, as required, at below 25C. The Department had told the receiving sites about the need to store Tamiflu below 25C, but they had not had the equipment to do this because the pandemic had happened quickly. The Department told us that, as it had been a cool summer, it had kept the Tamiflu and would have used it if it had been needed. The Department confirmed that it had disposed of the stock only when it reached the end of its shelf-life.[27] In 2010, the Department issued revised guidance to primary care providers on the correct procedures for storing antivirals.[28]

19   Q46; C&AG's Report para 3.1 and 3.30-3.31 Back

20   Q 50 Back

21   Cochrane Collaboration submission to the Committee, 20 June 2013. Back

22   Qq 21, 46; C&AG's Report para 11-12, Figure 4 Back

23   Qq 100-102 Back

24   Qq 91-92; C&AG's Report para 3.22 Back

25   Qq 93-95 Back

26   C&AG's Report para 3.22 Back

27   Qq 47, 49 Back

28   C&AG's Report para 3.31 Back

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Prepared 3 January 2013