Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-489"

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	"cs"^^xsd:language2
lpv:document identification number	"en.20100921.18.2-489"2
lpv:hasSubsequent	lp_eu:2010-09-21-Speech-2-4902
lpv:speaker	lp:Jiří Maštálka2
lpv:spokenAs	member; JURI (2009-07-16--2012-01-18)3 treasurer; EUL/NGL (2009-07-14--2014-06-30)3 unknown; Komunistická strana Čech a Moravy (2009-07-14--2014-06-30)3 substitute; ENVI (2009-07-16--2012-01-18)3 member; Parliament's Bureau (2009-07-15--2012-01-16)3 member; Delegation to the Euronest Parliamentary Assembly (2009-09-16--2014-06-30)3 member; Quaestors (2009-07-15--2012-01-16)3 quaestor; European Parliament (2009-07-15--2012-01-16)3 member; Delegation to the EU-Moldova Parliamentary Cooperation Committee (2009-09-16--2014-06-30)3
lpv:translated text	"Ladies and gentlemen, we are debating a serious topic, which involves medicines. Medicines preserve life, but they can also harm it in a dramatic way. As already mentioned here, the adverse effects of medicines have been shown to be the fifth most frequent cause of death among hospital patients. A strong, transparent and proactive system of pharmacovigilance is therefore essential for ensuring patient safety. I firmly believe that we have jointly achieved a major improvement in the text and better patient protection during negotiations over these legislative proposals. I very much welcome the system of direct notification, by means of which patients all over Europe can directly submit reports on adverse effects. This system will make it possible for adverse effects to be picked up earlier, and patients will be able to submit reports on effects which they might find it difficult to talk about with their doctor, for example, because they involve psychological or sexual factors. Patients will also be able to submit information both via the Internet and by using other methods, which is good for people who do not have a computer. We have strengthened patients’ right to information by improving access to information through the creation of a European web portal and the establishment of a European database on pharmacovigilance. Special attention was given to the protection of personal data in this area. We have achieved good results, but many things need improving: greater transparency in the decision making of competent authorities, the securing of essential resources for these authorities to do their work, ensuring that they are independent and that they have sustainable budgets, and, last but not least, adopting strict requirements over conflicts of interest in order to guarantee that decisions taken in the area of patient safety are not influenced by commercial interests. In conclusion, I, too, would like to thank the rapporteur for her excellent cooperation."@en1
lpv:videoURI	<go to Events_and_structure europarl>2

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