Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-22-Speech-3-146"
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"en.20100922.20.3-146"2
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"Mr President, on the subject of this text that we voted for, I would like to draw your attention – and I must congratulate Mrs McAvan for the quality of her work – to an omission regarding guinea pig populations.
In fact, there is one point that has been neglected, which, on account of the agreement concluded in first reading, could not be the subject of an oral amendment: it is a question of people used as guinea pigs for clinical tests of a medicine or vaccine conducted before authorisation in order to check its harmlessness or its risk-benefit balance.
These people may include men, women, children or elderly people; in this text, we are concerned with the follow-up of the possible side-effects of drugs for human use.
In fact, it must be pointed out that these people who participate in clinical tests are kept in ignorance as regards the substance ingested or injected and that the effects are only likely to be triggered ten, twenty or thirty years later.
These guinea pigs are the forgotten people of pharmacovigilance and it is important to remember this and mention it."@en1
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