Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-10-Speech-1-237-000"
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"en.20120910.29.1-237-000"2
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"Madam President, ladies and gentlemen, we will probably never know the number of deaths attributable to Mediator, which was placed on the market for the treatment of diabetes and was often prescribed, in reality, as an appetite suppressant. In any event, there have been too many victims of this system failure, in France anyway, where, as has already been mentioned, the drug was not withdrawn from the market until 2009, six years after the same decision was taken in Italy and Spain.
This scandal has quite clearly been the catalyst for the revisions we are debating this evening. These revisions are essential given the widespread but risky practice of marketing non-prescription medicines.
The shortcomings in the legislation we adopted in this very Chamber just two years ago are clearly highlighted. The legislative framework is reinforced where necessary. Yes, it is essential to compel manufacturers to give their reasons for withdrawing a drug from the market or for not applying to renew a marketing licence. Yes, this alarm, this triggering of the emergency procedure when practitioners stress that taking this medicine results in adverse patient reactions, must be made systematic.
Now we must remain realistic, so that this pharmacovigilance system can function effectively. It is for the national authorities and the London-based European Medicines Evaluation Agency (EMEA) to exercise greater control over the sector’s commercial players and to demonstrate greater independence from them."@en1
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