Local view for "http://purl.org/linkedpolitics/eu/plenary/2016-12-15-Speech-4-287-000"
| Predicate | Value (sorted: default) |
|---|---|
| rdf:type | |
| dcterms:Date | |
| dcterms:Is Part Of | |
| dcterms:Language | |
| lpv:document identification number |
"en.20161215.23.4-287-000"2
|
| lpv:hasSubsequent | |
| lpv:speaker | |
| lpv:spoken text |
"Today I voted in favour of this resolution which stems from Regulation No 1901/2006 on Paediatric medicines. It is important to foster innovation in paediatric medicines to ensure that in the future all children can be treated with medicines that have been developed for and proved effective and safe for use for children.
However I voted against Amendment 1 because effectively this amendment would mean that the regulators should not oblige companies to complete paediatric studies on medicines that could possibly prove to be ineffective or unsafe. The key change brought forward by the Paediatric Regulation, which I fully support, was to oblige companies to do Paediatric Investigation Plans on all new medicines which they develop, unless a waiver is granted. The 6-month patent or SPC extension is granted to companies who complete those Paediatric Investigation Plans, regardless of whether the new medicine will be authorised for use for children.
Amendment 1 effectively challenges the system of a compulsory PIP followed by a reward if the PIP is adequately completed. Companies are reluctant to complete paediatric studies because they mean additional costs for them, so it is absolutely necessary to have compulsory Paediatric Investigation Plans. This amendment was also rejected at committee level."@en1
|
| lpv:spokenAs | |
| lpv:unclassifiedMetadata |
Named graphs describing this resource:
The resource appears as object in 2 triples