Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-22-Speech-3-193"
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"en.20100922.20.3-193"2
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"Pharmacovigilance plays an important role in European public health, with almost 200 000 deaths every year reckoned to be caused by adverse drug reactions. Clinical tests are not sufficient to detect all the side-effects of drugs to be launched on the market. The cases involving the drugs Thalidomide or Vioxx are still too recent to forget.
I welcome the proposal to amend the EU provisions on triggering urgent legal procedures where dangerous situations involving drugs launched on the market are signalled, with rapid, coordinated action needing to be taken. The Commission has made the correct decision to replace the existing Pharmacovigilance working party with the Pharmacovigilance Risk Assessment Advisory Committee (PRAAC). Most experts have confirmed that the existing working party system works in a rather ad hoc manner, focusing only on drugs authorised through the central procedure and lacking the status to ensure that its findings are acted on by the Committee for Medicinal Products for Human Use, which oversees the whole system. I welcome the proposal to appoint two additional representatives on PRAAC, who will represent patients and medical staff."@en1
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