Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-383-000"

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"en.20120911.32.2-383-000"2
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"I voted in favour of the two McAvan reports (and) because they strengthen pharmacovigilance in the wake of the scandal surrounding the medicine marketed by the French pharmaceutical company under the brand name which highlighted serious weaknesses and malfunctions in the drug control system in the EU and the unacceptable lobbying methods applied by pharmaceutical companies. Although the side effects of were known as far back as 1998, it took eight years to withdraw it from the market and, as a result, some 500 people lost their lives and 3 500 were treated for heart conditions. The amendments which I supported plug gaps in the legislation in the form of a lack of evaluation of medicines once they have been authorised, their withdrawal without automatic notification of all EU Member States, the absence of evaluation and the lack of transparency surrounding withdrawal. The safety of medicines is a massive issue. We want informed patients helping health professionals with pharmacovigilance. The amendments which I supported (activation of the urgency procedure, clarification of transparency obligations for pharmaceutical companies and re-registration of suspect medicines in the list of medicinal products following additional monitoring) are designed to plug any gaps that may undermine the safety of medicines and the protection of public health."@en1

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