Local view for "http://purl.org/linkedpolitics/eu/plenary/2005-09-06-Speech-2-366"
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"en.20050906.36.2-366"2
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"Mr President, I should like to start by thanking the rapporteur, Mrs Grossetête, for her excellent work. I do think, though, that the Commission deserves criticism for being so tardy in presenting this proposal on medicinal products for paediatric use; after all, 100 million children in the EU are affected. That being the case, coordinated European action is not only important but indispensable. Why is that?
Three problem areas can be identified. The first is that the national markets for paediatric medicinal products are much too small to be of interest to pharmaceutical companies; only the Community market is large enough to be significant. Secondly, clinical trials on children should and must be avoided as far as possible. Where they are absolutely necessary, they must comply with the strict conditions of the Clinical Trials Directive. This makes it all the more necessary to make all test results centrally accessible, in order to avoid unnecessary duplication of trials.
Thirdly, the compulsory investigation of the potential effects of medicinal products on children which is provided for under the proposal must not impede the development of new medicinal products for adults. It follows that the Paediatric Committee, which is envisaged as forming part of the EMEA in London, has to assume the important role of resolving these issues quickly for the whole of the EU.
The committee should, of course, also be better placed to judge the need for medicines and studies when assessing draft paediatric investigation plans, exemptions and deferrals; and provide healthcare professionals and patients with a reliable source of information. This is the only way of better managing the organisation of the ethical and financial problems which paediatric medicinal products present.
We need to create a harmonised, functional European market in this field, so that we are finally able to give our children the medicines that they deserve, namely the best."@en1
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