Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-22-Speech-3-206"
| Predicate | Value (sorted: default) |
|---|---|
| rdf:type | |
| dcterms:Date | |
| dcterms:Is Part Of | |
| dcterms:Language | |
| lpv:document identification number |
"en.20100922.20.3-206"2
|
| lpv:hasSubsequent | |
| lpv:speaker | |
| lpv:spokenAs | |
| lpv:translated text |
"Pharmacovigilance, which means the assessment, detection and prevention of adverse drug reactions, is an extremely important subject, particularly in view of the fact that such reactions are the fifth largest cause of hospital deaths, resulting in an estimated 197 000 deaths a year in the European Union.
The whole process must be conducted with the greatest transparency and the competent authorities must be given adequate resources. The operations of these bodies must be guided exclusively by what is in the best interests of patients and public health, and they must therefore be public bodies independent of any commercial interests.
It is vital to have in place a system, involving healthcare professionals and patients, through which adverse drug reactions can be reported securely and reliably.
We share the rapporteur’s opinion that the Member States must remain key players in the EU pharmacovigilance system. The competent authority in each Member State should therefore continue to act as the clearing house for all spontaneous reporting of adverse drug reactions.
We also agree that the Member States must be informed immediately if a company reports an adverse drug reaction that happened on their territory to the EU’s database (Eudravigilance), and that the alert system proposed by the rapporteur should be set up."@en1
|
Named graphs describing this resource:
The resource appears as object in 2 triples