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.
8. The MHRA is confident that it, and other European
regulators, received all relevant information during the licensing
process for Tamiflu.
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.
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.
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.
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.
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.
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
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.
In 2010, the Department issued revised guidance to primary care
providers on the correct procedures for storing antivirals.
19 Q46; C&AG's Report para 3.1 and 3.30-3.31 Back
Q 50 Back
Cochrane Collaboration submission to the Committee, 20 June 2013. Back
Qq 21, 46; C&AG's Report para 11-12, Figure 4 Back
Qq 100-102 Back
Qq 91-92; C&AG's Report para 3.22 Back
Qq 93-95 Back
C&AG's Report para 3.22 Back
Qq 47, 49 Back
C&AG's Report para 3.31 Back