Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-487"

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	"el"^^xsd:language2
lpv:document identification number	"en.20100921.18.2-487"2
lpv:hasSubsequent	lp_eu:2010-09-21-Speech-2-4882
lpv:speaker	lp:Michail Tremopoulos2
lpv:spokenAs	unknown; Ecologist Greens (2009-07-14--2012-02-01)3 vice-chair; REGI (2009-07-20--2012-01-18)3 substitute; Delegation to the EU-Former Yugoslav Republic of Macedonia Joint Parliamentary Committee (2009-09-16--2012-02-01)3 member; G/EFA (2009-07-14--2012-02-01)3 substitute; ENVI (2009-07-16--2012-01-18)3 member; Delegation for relations with Albania, Bosnia and Herzegovina, Serbia, Montenegro and Kosovo (2009-09-16--2012-02-01)3
lpv:translated text	"Mr President, I, too, should like to thank the rapporteur, Mrs McAvan, for her well-drafted report and my fellow Member in the Group of the Greens/European Free Alliance, Mrs Rivasi, for her detailed work. Our initial concern was that this draft underpins a tendency for medicinal products to be hastily placed on the market, without detailed clinical trials, under a fast-track authorisation procedure, the thinking behind this being that there will be an enhanced system of pharmacovigilance and risk analysis and for reporting the undesirable effects of medicinal products. We were initially opposed to this and, in keeping with demands by civil society, we called for strict authorisation procedures before a medicinal product is placed on the market, during which a report would be submitted on the results of comparative clinical trials, together with proof of its added therapeutic value. I believe that this compromise attempts to get round this issue by strengthening the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency and by strengthening the procedure for civilian reports. The second point I wanted to raise has to do with the environmental impact and risk of medicinal products, on which we were ultimately unable to reach a compromise. The Commission should introduce a standard obligation, via the pharmacovigilance system, for the environmental impact to be monitored and reported and for these data to be compared with the results of trials presented by companies during the approval and authorisation procedure for new medicinal products. Unfortunately, all we managed to include in the compromise text was a call for the Member States to consider the next stage for monitoring the environmental impact and for the Commission to present a report analysing the extent of the problem and whether or not the current legislation needs to be amended."@en1
lpv:videoURI	<go to Events_and_structure europarl>2

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