Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-10-Speech-1-236-000"
| Predicate | Value (sorted: default) |
|---|---|
| rdf:type | |
| dcterms:Date | |
| dcterms:Is Part Of | |
| dcterms:Language | |
| lpv:document identification number |
"en.20120910.29.1-236-000"2
|
| lpv:hasSubsequent | |
| lpv:speaker | |
| lpv:spokenAs | |
| lpv:translated text |
"Madam President, the stress testing of legislation in the area of pharmacovigilance has exposed serious shortcomings in the EU system, which we must resolve, as no shortcomings can be allowed in the safety area of our drugs policy.
The Mediator drug mentioned earlier was registered in many European countries through national procedures, and despite the fact that the first reports of undesirable effects in its main active ingredient – mentioning fears of potential heart valve failure – appeared as early as 1999, the drug was prescribed very widely in Europe up to 2009, when it was taken off the market, with prescriptions handed out to 5 million people. The number of deaths related to this medicine is estimated to be as high as 2 000, up to 2 000 people.
Despite the fact that concerns over this drug were discussed by regulatory bodies at various meetings at European level, and despite all of the properly documented concerns, no decision was taken for this drug to undergo scientific assessment at EU level. The regulatory bodies took no further measures.
These facts show very clearly that safety in respect of drugs policy and drugs must be reinforced at EU level. I therefore support the aim of revising the legislation from 2010 and, at the same time, I would like to emphasise the need to achieve this amendment as quickly as possible, in the interests of public health. I would also like to thank the rapporteur very much for the finely drafted opinion."@en1
|
| lpv:videoURI |
Named graphs describing this resource:
The resource appears as object in 2 triples