Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-024"
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"en.20081022.2.3-024"2
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"Mr President, I shall not speak for a very long time, but I might speak for longer than my allocated time.
I would like to say to the Commissioner that it is undoubtedly a fact that the current system of dealing with variations in the terms of marketing authorisations for medicinal products is unsatisfactory and, in many cases, works against the interests both of the pharmaceutical industry, but also – most importantly – of the patients themselves. It is therefore essential that the revision should be conducted.
In this respect, the Commission’s proposal, and indeed Mrs Grossetête’s report, are, overall, sound and fair and should meet with our agreement. I would, however, like to register my reservations in relation to the following point which concerns the extension of marketing authorisations.
The Commission and the rapporteur both seem, in my understanding, to agree that it should be possible for an authorised drug to have its name completely changed if it is found that it has a new pathology application. For example, the drug aspirin, whose active ingredient is salicylic acid, could, if the Commission’s proposal is adopted, be marketed with a number of different names, even though the chemical component is exactly the same – i.e. salicylic acid. Hence, a patient could end up taking three different tablets, all looking different and having a different name, for three different pathologies, whereas in reality, all three tablets would be exactly the same as far as their chemical composition is concerned – i.e. he would, in effect, be taking three tablets of aspirin.
This is, in my view, misleading and confusing to the patient and to the doctor, and increases the risk of overdosing and of causing dangerous side effects. I therefore call on both the Commission and the rapporteur to have second thoughts on this point.
Since I have a few more seconds, I would like to say that, on the question of counterfeiting medicines, I agree entirely with the Commissioner that this is a criminal offence and it puts at risk the lives of patients. But I fail to see why there is a delay. This is a straightforward case as far as I understand. These medicines, which are produced by registered pharmaceutical companies, are sold under prescription by registered pharmacists. If we cannot get to the bottom of this and discover whether some of these are criminally manufactured, then I do not know what we in the EU can do. I would have thought that this is more a police case than a change-in-legislation case. Commissioner, we should get to the bottom of this as fast as possible."@en1
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