Local view for "http://purl.org/linkedpolitics/eu/plenary/2011-03-07-Speech-1-189-000"
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"en.20110307.23.1-189-000"2
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"Mr President, we all remember that H1N1 influenza was big news in 2009. The first cases were reported almost two years ago – on 25 March 2009 – and the WHO declared a phase 6 alert level on 11 June 2009.
Finally, I would like to highlight the cases of narcolepsy that have been reported in children in Finland and Sweden following vaccination with GSK’s H1N1 influenza vaccine. These cases need our attention.
In the first instance, they clearly demonstrate that there are still grey areas, both in relation to the actual toxicity of the vaccines and adjuvants and in relation to possible risks as yet unknown to the manufacturers themselves. Finland has suspended the use of this vaccine until more information is available. This is not the position of the European Medicines Agency (EMA), which has decided instead to wait until more information is available before issuing any opinion on restricting the use of this vaccine. I would like to see the Commission adopt the same position as Finland. It is time that the precautionary principle benefited patients for once instead of always benefiting the companies.
This maximum alert level issued by the WHO triggered a series of measures in Europe, including the activation of immunisation campaigns in several Member States which not only were very costly but were also overestimated in relation to the known severity of the virus, which, as the WHO stated at that time in May 2009, was moderate.
As regards severity, up to the end of April 2010, this flu had caused around 2 900 deaths in Europe, in other words, a much lower mortality rate than that related to seasonal flu, which causes an estimated 40 000 - 220 000 deaths per year depending on the year.
Meanwhile, the estimated costs were close to EUR 1.3 billion in the United Kingdom and over EUR 700 million in France according to the latest Court of Auditors report.
The evaluation of the management of H1N1 influenza shows that there was a disproportionate response in the European Union and the Member States. I and my colleagues, whom I would like to thank for their amendments, have therefore tried to produce a constructive report which aims to restore the confidence of European citizens in their health institutions.
The report is structured around three major themes: cooperation, transparency and independence.
In terms of cooperation, we are keen to stress the need for coherence, effectiveness, autonomy and flexibility. Future flu prevention plans, for example, must be revised in such a way as to guarantee greater coherence and effectiveness and must be made self-contained and flexible enough that they can be adapted in real time according to the latest available data. This kind of flexibility would have saved our public purses a good deal of unnecessary expense. At the same time, it is important to clearly define the roles and responsibilities of the key players responsible for managing health risks. The definition of a pandemic itself must be revised so that it includes the concept of severity and does not just take account of geographical spread. Indeed, the WHO has informed us that it has this in hand. Group purchasing of vaccines is a possibility, provided that the manufacturers remain liable for the quality, safety and efficacy of their products. Under no circumstances must governments be made liable for side effects of vaccines that are supposed to be safe.
As regards independence, the fast-track authorisation procedure has highlighted the problem of the lack of available scientific data. Research into vaccines and antiviral treatments must be conducted with complete independence from the pharmaceutical companies.
In terms of transparency, total transparency is needed concerning the evaluation of drugs used for health emergencies, with full access to the clinical trials available. All declarations of interest on the part of the experts responsible for the evaluations must be made public. I have one regret: I would have preferred them to be checked by the agencies who recruit these experts, but this amendment was not adopted."@en1
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