Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-10-22-Speech-2-041"
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"en.20021022.1.2-041"2
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"Mr President, Commissioner, ladies and gentlemen, I basically support the Commission proposal and the reports by Mrs Grossetête and Mrs Müller. However, there are a few points on which I differ. One point was not mentioned in the debate at all, although I believe it to be very important: the Commission has proposed that prescriptions would also be required for medicinal products under the decentralised procedure. I believe that this is a step in the right direction, but we should not throw out the baby with the bathwater. I think we need to be careful about ending up in a situation where all medical products that are at present available over the counter require prescriptions, because that would certainly create problems for consumers and would impose unreasonable costs on the health system. I therefore urge you to support Amendment No 151, which I have tabled jointly with several of my colleagues.
The second important point has already been mentioned many times, but we cannot consider it often enough. We need to come to an arrangement that is acceptable for small and medium-sized pharmaceutical companies. We cannot adopt legislation that, ultimately, only global players like Pfizer can comply with. We need rules that are appropriate for SMEs. In this connection there are a number of important issues, such as the amendment tabled by Mr Nisticò. Three years' data exclusivity in the event of a new indication is something that SMEs are perhaps in a better position to implement than data exclusivity for a totally new substance.
In committee, I spoke against the pilot project on information and advertising, as I simply cannot understand why the information provided should be extended for three special indications but with far tighter rules in other areas. We need information for all indications and all diseases, and advertising for prescription medicines should be totally ruled out. That is why I agree with the conclusion reached by the committee. However, the committee overshot the mark on a couple of points, so that information that the pharmaceutical industry is allowed to provide now would in future no longer be permissible. We need to sort that out in tomorrow's vote.
In conclusion I wish to call on the Commission to bring forward a proposal on medical product safety for children as soon as possible. I know that the Commission officials here today and the Commissioner himself regard this as a very important subject, but we have already been waiting too long for a definite legislative proposal. I urge you to present one before the year is out."@en1
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