Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-10-Speech-1-251-750"
| Predicate | Value (sorted: default) |
|---|---|
| rdf:type | |
| dcterms:Date | |
| dcterms:Is Part Of | |
| dcterms:Language | |
| lpv:document identification number |
"en.20120910.29.1-251-750"2
|
| lpv:hasSubsequent | |
| lpv:speaker | |
| lpv:spokenAs | |
| lpv:translated text |
"The amendments to pharmacovigilance legislation finally introduce the principle of the automatic evaluation of a medicinal product at EU level if the product is withdrawn in a Member State. They also extend the list of drugs subject to additional monitoring. However, the Commission did the very bare minimum after the Mediator scandal. We should remember that its initial proposals on the texts adopted in 2010 were quite simply unacceptable. We had to fight to get rid of measures that were very favourable to the laboratories, making it easier for them to put on the market drugs that had been insufficiently tested with no therapeutic justification in terms of risk and benefit. Unfortunately, these minor changes do not integrate the fundamental measures we had asked for: the financial, hierarchical and intellectual independence of pharmacovigilance activities relating to the industry and medicines agencies, and the implementation of the requirement to demonstrate therapeutic progress in order to obtain a marketing licence. Nonetheless, Ms McAvan’s reports still represent progress in the expectation that a truly ambitious text will be proposed at the earliest possible opportunity."@en1
|
Named graphs describing this resource:
The resource appears as object in 2 triples