Local view for "http://purl.org/linkedpolitics/eu/plenary/2005-09-06-Speech-2-347"
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".
Mr President, that this regulation is of paramount importance to the consumer goes without saying. It is also a good example of what Europe can mean to the citizen, exactly at a time when many citizens appear to be in doubt about this, and deserves all our support for that reason.
The regulation is so important because at present, children are all too often prescribed medicines that have not been developed for children or tested on them, and so the positive or negative effects that the use of these medicines may have on a child are often not known, with all the consequences that this entails. It is therefore vital that more should be invested in the development of medicines that are specifically tailored to children. The proposal is right to try to promote the development of sound and safe children’s medicines by requiring producers of medicines, whenever they apply for a license to market one, to examine its suitability for children.
Another good example that has been mentioned before is the creation of a children’s medicine committee that will be responsible for the assessment and approval of plans for paediatric research. Similarly, the rapporteur’s proposal in connection with the investigation programme for paediatric research, MICE, for funding research into the paediatric use of medicines that are not protected by a patent or additional protection certificate, will considerably stimulate the production of children’s medicines. I also believe in general that investments are needed, particularly in innovation, more so than in patent protection, the subject we are debating today.
Research involving children should, of course, be done with due care. Double trials must be avoided and all kinds of measures must be taken to prevent them being carried out. I am also delighted that the Committee on the Environment, Public Health and Food Safety has already approved a number of amendments to that effect.
I agree with anyone who says that it is regrettable that in this discussion, we have apparently lost sight of the importance of the child amid the discussions that focus on who in the industry should reap most benefits. In fact, I think that both sides are guilty of this and it is extremely frustrating indeed.
In principle, I think that such a patent extension should be as short as possible, for in the final analysis, it is the user, or the citizen, who picks up the tab. It is their money we are carving up. A patent is a temporary monopoly that is granted to promote innovation, but in this proposal, research is a requirement and the patent a way of recovering costs, and that is what sets us apart from the United States.
I would therefore be tempted to move the spotlight away from patent protection. We have decided in favour of five months while the rapporteur made a passionate plea for six. I myself have changed my mind, first from a flexible period to four months, and I have now proposed five months. Your plea has therefore not been an entire waste. I do fear, though, that we have not really moved any closer to each other, although I value the rapporteur’s work."@en1
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