Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-10-22-Speech-2-034"

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"Mr President, ladies and gentlemen, I would like to compliment both rapporteurs on their excellent work. I believe that these proposals provide a good basis for ensuring that the internal market in medical products operates properly for medicines for both human and veterinary use. As far as I am concerned the hallmark of an internal market is not price stability, but comparable prices, which is something altogether different and really has nothing to do with the internal market. These proposals will also give a continuing boost to research, making research worthwhile again and also enabling manufacturers of generic drugs to make a living. I also believe that these proposals will make it possible to take advantage of all the options for maintaining public health. Harmonising data exclusivity in the European Union will particularly promote research, and at the same time make the task of generic drug manufacturers easier. I fully support this and those affected should not need to make any further demands. However, as I see it, extending the centralised authorisation procedure for medicinal products, as advocated by the Commission in committee, is not in accordance with the principles that have been mentioned. The present twofold authorisation procedure fully meets the requirements of the internal market and guarantees a greater variety of medicinal products, and with lower charges. The new plan to impose use of the centralised procedure for products with new active substances will undermine competition between the authorisation procedures. We can include as many processing deadlines as we like in the regulation, but without any competition these figures are meaningless. I know a great many SMEs that carry out research and in particular companies that are doing research and development in the field of ‘orphan drugs’ or veterinary medicines. That is where active substances of this kind are developed. Authorisation for these would have to be applied for in London, and I believe that these companies cannot afford that, nor can they put it into practice. So what we will end up achieving is to halt this kind of research, which really is not acceptable. We should therefore refuse to support the change proposed here."@en1

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