Local view for "http://purl.org/linkedpolitics/eu/plenary/2005-09-06-Speech-2-353"

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"en.20050906.36.2-353"2
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"Mr President, Commissioner, ladies and gentlemen, we have been wanting and waiting for this text on which we are going to vote for a long time, and we are all very happy to know that it will soon enable our children to be better cared for. Nevertheless, we must be demanding. Tomorrow, we will have the opportunity to improve this proposal for a regulation so that it best serves the interests of children and public health, and we will improve it by adopting those amendments focussing on research into and the placing on the market of medicinal products with the greatest added value, providing a real therapeutic benefit; indeed, how can we achieve the objective of limiting clinical trials on children without limiting the number of medicinal products placed on the market? If the criterion of the medicinal product’s added value were taken into consideration, this would avoid many unnecessary studies in children. We will also be able to improve the text tomorrow by adopting the amendments that propose greater transparency for pharmacovigilance data and their accessibility to the public. The financial issue is also important for the stability of our social security systems and the guarantee of access to healthcare for all. It is increasingly important when it comes to finding the right financial incentive so that the pharmaceutical industries take a greater interest in paediatric medicinal products. It is important for all European citizens, because it is public money that indirectly finances these financial incentives in the form of the extension of market exclusivity. That is why, in view of the results of the impact assessments, in view of the enormous gaps ranging from EUR 1 to 4 million, it seems to me that we should at least be able to suggest to the industry a two-stage system: a fixed three-month incentive and a three-month extension depending on the level of benefit provided by the medicinal product sold. All of us here want the best for our children, as soon as possible, but we must not be hypocritical. Those who are talking about urgency were not willing to support the proposal to reduce the gap between marketing authorisation and placing on the market, which is currently two years. That is why we will have other meetings and we will really see what we can do for the health of European children."@en1

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