Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-495"

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	"fr"^^xsd:language2
lpv:document identification number	"en.20100921.18.2-495"2
lpv:hasSubsequent	lp_eu:2010-09-21-Speech-2-4962
lpv:speaker	lp:Françoise Grossetête2
lpv:spokenAs	member; EPP (2009-07-14--2014-06-30)3 substitute; Delegation for relations with Australia and New Zealand (2009-09-16--2014-06-30)3 member; ENVI (2009-07-16--2012-01-18)3 substitute; ITRE (2009-07-16--2012-01-18)3 member; Delegation for relations with the countries of Central America (2009-09-16--2014-06-30)3 member; Delegation to the Euro-Latin American Parliamentary Assembly (2009-09-16--2014-06-30)3 unknown; Union pour un Mouvement Populaire (2009-07-14--2014-06-30)3
lpv:translated text	"Mr President, Commissioner, we are debating pharmacovigilance. This is an important pillar of the pharmaceutical package on which we have been working for some time, and this agreement at first reading will give patients better protection from the risks associated with the use of medicinal products. This agreement is therefore a big step forward for patient safety, because rare patterns can be picked up more quickly and unsafe medicines can be withdrawn from the market when required. We are not, in fact, reinventing pharmacovigilance; we are simply improving the situation on the basis of improved knowledge of the risks linked to medicinal products, thanks to greater cooperation between the competent authorities. The point of this regulation is to improve our knowledge of adverse reactions, thanks to the development within the European Medicines Agency of the EudraVigilance database, which will become the single point of receipt and consultation of all medicine-related information. This will help improve communication between the competent authorities. The national authorities will also be better able to re-evaluate the risk/benefit balance by reactively entering and integrating all signals or new data, and adapting information for health professionals and patients accordingly. However, we must also take care not to frighten patients with excessive warnings; providing too much information could ultimately prove harmful. Medicines are complex products. We need to explain them, to provide proper information, but, above all, we must not be over-alarming. It is clear, today, that package leaflets are no longer as relevant. They are sometimes hard to read. It is now necessary to address how they should evolve, with all the partners, so as to improve patients’ understanding and, above all, give them confidence in medicinal products."@en1
lpv:videoURI	<go to Events_and_structure europarl>2

Named graphs describing this resource:

The resource appears as object in 2 triples

Context graph