Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-486"

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	"en"^^xsd:language2
lpv:document identification number	"en.20100921.18.2-486"2
lpv:hasSubsequent	lp_eu:2010-09-21-Speech-2-4872
lpv:speaker	lp:Antonyia Parvanova2
lpv:spoken text	"Mr President, let me first thank Linda McAvan for the incredible intelligence with which she has tackled this very technical dossier, as well as the shadow rapporteurs, the Commission and the Council for the fruitful cooperation which has been crucial in reaching this first reading agreement, paving the way towards a safer, more efficient and more transparent pharmacovigilance system in Europe. As shadow rapporteur for the ALDE Group, I very much welcome this agreement concluded under the Spanish Presidency, and the fact that Parliament’s position remains firmly included in the final text. One may say that we are dealing today with a less exciting dossier within the pharma package, but pharmacovigilance is actually crucial in ensuring observance of some of the key principles which have guided the ALDE position towards patients’ trust in pharmaceutical treatments. The development and smooth functioning of EudraVigilance, collecting Adverse Drug Reactions at the larger European scale, as well as the better coordination with national authorities and pharmaceutical companies, are major steps towards making sure risks relating to the use of medicinal products are duly assessed in a timely manner. Patient safety will also be reinforced, with the possibility for authorities to request efficacy studies after a product has been authorised on the market. For the first time here, we will be able to use health technology assessment in order to avoid putting patients’ lives at risk. Transparency has been one of Parliament’s guiding principles during the negotiations. While avoiding any misuse of the information available, more transparent communication about pharmacovigilance activities will enhance patients’ trust in their treatment, as well in the authorities that guarantee their safety. To conclude, the changes made to the pharmacovigilance system in Europe should be a tool to reinforce European citizens’ confidence and understanding of the medicines they are taking. In this regard, I very much welcome the call for a broader and complete review of the Patient Information Leaflet. We have a public health responsibility to guarantee the highest level of safety, efficiency and transparency in the future European pharmacovigilance system to be implemented."@en1
lpv:spokenAs	member; FEMM (2009-07-16--2012-01-18)3 member; Delegation to the Parliamentary Assembly of the Union for the Mediterranean (2009-09-16--2014-06-30)3 substitute; Delegation for relations with Iran (2009-09-16--2014-06-30)3 unknown; National Movement for Stability and Progress (2009-07-14--2014-06-30)3 vice-chair; ALDE (2009-07-14--2012-01-26)3 substitute; IMCO (2009-07-16--2012-01-18)3 member; ENVI (2009-07-16--2012-01-18)3 member; Delegation for relations with Canada (2009-09-16--2014-06-30)3 substitute; Delegation for relations with the Mashreq countries (2009-09-16--2014-06-30)3
lpv:unclassifiedMetadata	"Antonyia Parvanova,"1 "on behalf of the ALDE Group."1
lpv:videoURI	<go to Events_and_structure europarl>2

Named graphs describing this resource:

The resource appears as object in 2 triples

Context graph