Local view for "http://purl.org/linkedpolitics/eu/plenary/2005-09-06-Speech-2-345"
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"en.20050906.36.2-345"2
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".
Mr President, 20% of our citizens are under 19 years of age; in other words, 100 million of our fellow European citizens are children. That is who we are talking about today. We are talking about half the medicines we provide to help them through their young lives not being properly researched, tested or authorised. We have what I call 'the half-an-aspirin syndrome': you give a child half the dose you would give an adult, because you think it ought to have less than the full dose. That may do no harm, it may do no good or it may even harm the child, because it may not be correct for it to have the dose at all, or it should have more or less than that. Therefore I very much welcome both the Commission's proposal and the rapporteur's report.
The key is how we provide incentives to research. That is what we want and what our children need. We have to maintain a balance between the need for more research and the need to keep costs under control.
The rapporteur has mentioned the example of the United States. Since the system was introduced there in the 1990s, over one hundred new children-specific medicines have come on stream. We want to catch up with that.
The debate we have had, and perhaps are still having, centres on the patent extension. Some wanted a variable number of months; some wanted a longer period, others a shorter period. The Commission proposed six months; the Council – or 22 Member States in the Council – proposed six months; the rapporteur proposed six months; the committee agreed six months. It must be said that six months is right: it is simple and is a single extension.
I am also concerned that we avoid double extensions and double claims. Therefore, the aim of my amendment to Article 36 was to make clear that we should not have double rewards for the same paediatric formulation. We need to ensure that it is correctly worded. That is something that the Council and the Commission will now be able to look at. However, when I hear, on the one side, companies saying that it is going too far and, on the other side, generics saying that it is not going far enough, perhaps we have got it right.
We welcome the MICE. We do not often welcome MICE into this Chamber, but the MICE – the fund for paediatric medicine research – is very much to be welcomed. The report as a whole and the Commission's proposal are good and will help the two million children who have health problems now and could be helped through this measure in the future."@en1
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