Local view for "http://purl.org/linkedpolitics/eu/plenary/2006-05-31-Speech-3-170"
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"en.20060531.16.3-170"2
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"Madam President, the aim of the Parliament and Council regulation on medicinal products for paediatric use is to improve children’s health in Europe by developing specific medicinal products designed to help children combat disease. I would like to thank Mrs Grossetête for the excellent work she has done on this regulation. It is apparent that she has put in a great deal of effort, commitment and skill.
Health, and particularly children’s health, is a priority in itself. When raising a sensitive issue such as medication for children, however, we should ask ourselves an honest question, namely whether it is possible to claim beyond doubt that prescribing adult medication to children is more ethical than involving children in controlled studies that are subject to stringent legislative provisions. This is a question we should all ask ourselves, and which should form the basis for further discussion. Unfortunately, we do not have much time for this at the moment.
With regards to the regulation, however, I am definitely opposed to reducing the period during which a company can apply to extend sole marketing authorisation for the basic product from two years to six months. This proposal was voted on at first reading, when only 1% of votes cast in Parliament were in favour of it. The amendment was supported neither by the Council, nor by the Commission.
I would like to express my regret that due to lack of support during the vote in May, no amendments were adopted to prevent abuse of the system of remuneration and incentives that are permissible under the provisions of the regulation under discussion. I am keen that companies should not accumulate preferential instruments and remuneration for conducting the same studies for the same product, which would lead to abuse on too many occasions.
On the other hand, I do believe that it is important that producers of medicinal products be reimbursed for the costs incurred when carrying out trials of the use of medicines in children. Such compensation could take the form of patenting new means of administering medication or forms of a medicinal substance and of giving sole marketing rights for medicinal products for children.
It is important here to stress that medicinal products used in adults should only be subject to investigation for their use in children where this is reasonable and necessary. Finally, I would like to express my full support for the establishment of a Paediatrics Research Committee made up of members with specialist knowledge and competence, and who are independent experts in their fields. I believe this to be a very positive solution."@en1
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