Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-482"
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"en.20100921.18.2-482"2
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"Mr President, I am going to take one minute and I shall speak for a further minute afterwards. I should like to speak first as rapporteur for the opinion of the Committee on Industry, Research and Energy and to thank the rapporteur, Mrs McAvan, for this report.
I should like to say that it is very important in this sector to provide patients with better protection and better information, but also to fight against the stranglehold exerted by the pharmaceutical industry, which wanted to collect reports of side effects and to analyse and interpret the results.
At the level of the Committee on Industry, Research and Energy – and, moreover, at the level of the Committee on the Environment, Public Health and Food Safety – we therefore succeeding in ensuring that, when it comes to the collection of reports, doctors and patients will be the ones able to report side effects for transmission to the national authorities.
As far as analysis and interpretation are concerned, the Member States are responsible for detecting and monitoring the adverse reactions of medicinal products. It transpired, in connection with the outbreak of H1N1 influenza, that it was the Swedish national authorities which referred to narcolepsy even though, until now, the H1N1 vaccine had not been associated with such side effects. This is very important. On the other hand, I am very disappointed that we have not achieved financial independence from the national authorities.
Finally, as far as controls are concerned, there has been real progress in relation to this Pharmacovigilance Committee, which is separate from the Committee for Medicinal Products for Human Use, and I hope that there will also be more information available for patients, either on package leaflets or in terms of ultra-vigilance."@en1
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