Local view for "http://purl.org/linkedpolitics/eu/plenary/2003-12-16-Speech-2-275"

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"Mr President, ladies and gentlemen, this House and our fellow Members have contributed, through their many amendments over the last two weeks, to ensuring that we could achieve a good compromise with the Council. I believe this compromise is a gift to European citizens and not, as some Members of the House might think, to the pharmaceuticals industry. I take a different view. Those of us who have worked intensively on this package of legislation and are familiar with the details also know that the situation is different. With the EMEA, we have created efficient structures which safeguard the quality of evaluations, thus ensuring that safe medicinal products are available to patients. We have a database containing a wealth of information for patients, doctors and, indeed, for companies themselves. We have transparent authorisation procedures, and we have information about adverse reactions, to cite just a few examples of what we have achieved for patients. We have a centralised authorisation procedure which covers a wide range of indications. As a result, a great many new and innovative medicinal products are subject to the centralised procedure and can be made available at an early stage to patients. We have asked the Commission to compile information and guidelines to ensure that the information supplied to patients is genuinely independent. All these are things which directly benefit patients. In five years’ time, we will have a new authorisation procedure, which will include a cost-benefit analysis. In other words, we have achieved a great deal for patients. That is why I would ask everyone to be rather more cautious, perhaps, in their arguments for and against this package. On the two points concerning the WTO, I have tabled an amendment myself, but I think the most sensible approach is for the Commission to put forward a proposal next year which deals fully with this topic and does not simply produce detailed legislation on the hoof, which would not be a good approach. I therefore urge all fellow Members who may have a rather critical viewpoint to support this compromise tomorrow. It will benefit Europe’s citizens, and that is a real gift to patients, no one else."@en1

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