Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-236-000"
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"en.20120911.32.2-236-000"2
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"Mr President, as a medical doctor, I support these measures strongly. In 2010, it was decided that EU rules governing pharmacovigilance had to be revised and a stress test was carried out on the legislation which demonstrated weaknesses in the system, which now need addressing.
These current proposed changes aim to close dangerous loopholes to protect our patients in Europe. In particular, they seek to meet the need for an automatic, urgent EU-wide procedure in cases where a Member State or the Commission considers that serious adverse side effects have occurred and therefore, there is a need to prohibit the supply of a particular medicine. They also seek to clarify the transparency obligations on pharmaceutical companies, namely, that companies are obliged to inform the European Medicines Agency, which is a very successful agency based in my own region of London, when a medicinal product is deemed to be harmful and this agency is then, in turn, obliged to inform all Member States without undue delay. So pharmacovigilance is a good thing and it is something which can be done well at EU level."@en1
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