Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-369-000"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2012-09-11"^^xsd:date2
dcterms:Is Part Of	lp_eu:Explanations of vote2
dcterms:Language	"pt"^^xsd:language2
lpv:document identification number	"en.20120911.32.2-369-000"2
lpv:hasSubsequent	lp_eu:2012-09-11-Speech-2-370-0002
lpv:speaker	lp:João Ferreira2
lpv:spokenAs	member; Delegation to the EU-Former Yugoslav Republic of Macedonia Joint Parliamentary Committee (2009-09-16--2013-02-03)3 unknown; Partido Comunista Português (2009-07-14--2014-06-30)3 substitute; Delegation for relations with the countries of the Andean Community (2009-09-16--2014-06-30)3 vice-chair; EUL/NGL (2012-02-07--2014-06-30)3 member; PECH (2012-01-19--2014-06-30)3 member; Delegation to the ACP-EU Joint Parliamentary Assembly (2009-09-16--2014-06-30)3 substitute; ENVI (2012-01-19--2014-06-30)3 substitute; BUDG (2012-01-19--2014-06-30)3
lpv:translated text	"Pharmacovigilance has been under review since December 2010, with a view to its implementation from this year, so as to make medicines safer at EU level by increasing the role of the European Medicines Agency in evaluating, detecting and preventing adverse reactions to medicines, as well as to increase cooperation between Member States. As we have stated in previous reports on this very subject, there are aspects of the changes under way that could improve the workings of this mechanism for evaluating, detecting and preventing adverse reactions to medicines. This need for improvement was made obvious with the tragic outcome of the Mediator case, involving a diabetes medicine that caused the deaths of 500 to 2 000 people. Pharmacovigilance is unquestionably an important subject, particularly as adverse reactions to medicines are the fifth most important cause of hospital deaths in the EU, responsible for an estimated 197 000 deaths a year. We insist on the Member States continuing to play a key role in the EU pharmacovigilance system. The competent authorities in the Member States should therefore continue to act as the clearing house for all spontaneous reporting of adverse drug reactions."@en1

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