Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-22-Speech-3-200"
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"en.20100922.20.3-200"2
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"Despite the requirement for exhaustive clinical testing and a Marketing Authorisation (MA), medicines have serious side effects which very often require hospital admission but also frequently cause deaths in the European Union.
I am pleased that the European Parliament has adopted the legislation on pharmacovigilance, which strengthens provisions on this subject in European legislation concerning medicines for human use.
Henceforth, patients will be able to report any undesirable effects of a medicine directly. At the same time, the setting up of a European web portal will improve information on medicines. I welcome the provisions in relation to the protection of personal data. These provisions will improve the safety and quality of medicines for patients.
Nonetheless, improvement is still needed in the funding for pharmacovigilance which, at present, still remains dependent on fees paid by laboratories (and therefore on their goodwill) and in ensuring the independence of the Risk Assessment Advisory Committee in relation to the European Medicines Agency, which issues a large number of MAs for medicines in the European Union.
The ball is now in the Commission’s court, particularly with regard to improving patient information leaflets."@en1
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