Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-10-22-Speech-2-039"
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"en.20021022.1.2-039"2
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"Mr President, Commissioner, ladies and gentlemen, I would like thank Mrs Grossetête and Mrs Müller for their very full reports. Tomorrow we will be voting on the most important revision package to date as regards legislation on medicinal products in the European Union. The key objectives here are as follows: first, achieving a high level of health protection and giving patients rapid access to innovative products; second, the quality, safety and effectiveness of medicinal products in Europe; and, third, further dismantling existing barriers to trade within the internal market.
Medicinal products need to be used appropriately and correctly. That is why it is vital for the law to make a clear distinction between information and advertising. All product information should be scientifically checked before it is published. Provisions relating to medicinal products should only apply to products that have a therapeutic benefit and are used therapeutically. Any overlap with food law should be avoided in order to obviate legal uncertainty. For this reason a clear definition of medicinal products and food is urgently needed, as provided for in Amendments Nos 11 and 18.
The achievements of industrial research as regards innovative therapeutic uses should be recognised by means of appropriate data exclusivity for what are termed ‘original products’. I am, however, also supporting Amendment No 40, which grants existing medicinal products an additional three years' data exclusivity in the event of a new indication. Generic drugs, which must of course meet all requirements as regards quality, safety and effectiveness, should also be established in the European market and it should be possible to market them as soon as the period of protection for the original drug has expired.
The authorisation procedure is to retain the option of choice between the centralised and decentralised procedures, which has existed since 1995. It has resulted in a marked increase in the efficiency of the authorisation procedures and has not led to the polarisation that some feared. It is essential that mutual recognition should continue for the sake of Europe's small and medium-sized enterprises. We need to create a system that promotes innovation in the interests of all patients."@en1
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