Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-502"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2010-09-21"^^xsd:date2
dcterms:Is Part Of	lp_eu:Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)2
dcterms:Language	"it"^^xsd:language2
lpv:document identification number	"en.20100921.18.2-502"2
lpv:hasSubsequent	lp_eu:2010-09-21-Speech-2-5032
lpv:speaker	lp:Licia Ronzulli2
lpv:spokenAs	member; EMPL (2009-07-16--2012-01-18)3 substitute; Delegation for relations with the countries of South Asia (2009-09-16--2014-06-30)3 member_of_the_bureau; EPP (2009-09-16--2014-06-30)3 substitute; ENVI (2009-09-29--2011-06-26)3 substitute; DROI (2009-07-16--2012-01-18)3 vice-chair; Delegation to the ACP-EU Joint Parliamentary Assembly (2009-09-17--2014-06-30)3 unknown; Il Popolo della Libertà (2009-07-14--2013-12-05)3
lpv:translated text	"Mr President, Commissioner Tajani, ladies and gentlemen, the main aim of this proposal for a regulation is to verify the safety of medicinal products once they have been authorised for public use. There can never be too many checks and evaluations of positive or negative reactions. An estimated 197 000 deaths per year are caused by adverse drug reactions (ADRs) within the European Union. Clinical trials can often miss side effects from drugs if they are rare, only appear after long-term use, or involve interaction with other drugs. Tracking drug use and reporting on ADRs is, and must remain, a priority of European public health policy. A good pharmacovigilance system must make it possible for healthcare professionals, companies and patients themselves to report ADRs and also allow for signals pointing to potential problems to be detected. These signals must then be followed up with action, which can include changes to the way a medicine is prescribed, better information on how it is used or, where the nature of the ADR is severe, the withdrawal of the medicine altogether. The proposal to strengthen cooperation in pharmacovigilance may offer numerous advantages insofar as the pool of reported ADRs is larger, meaning that rarer patterns can also be picked up more quickly. Therefore, unsafe medicines can be withdrawn more quickly from the market if necessary. All the Members States must remain key players in the EU pharmacovigilance system. I shall conclude, Mr President, by emphasising the importance of allowing direct patient reporting of ADRs. Unfortunately, at present, only a few Member States accept direct reporting, and I am happy to point out that, where it exists, this system has not overburdened the competent authority."@en1
lpv:videoURI	<go to Events_and_structure europarl>2

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