Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-10-Speech-1-235-000"
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"en.20120910.29.1-235-000"2
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"Madam President, Commissioner, ladies and gentlemen, what happened in the Mediator case really was a major scandal. We do not know exactly how many people lost their lives – reports vary from 500 to 2 000 – but every death is one too many. This was a case of irresponsible behaviour on the part of the company but, unfortunately, there were also gaps in the law. These gaps in the law urgently need to be closed. I would therefore like to offer my heartfelt thanks to Ms McAvan, to the shadow rapporteurs and, in particular, to Ms Ayuso in my group, and to Commissioner Dalli, who produced this proposal efficiently and guided the whole process very constructively.
It is important that, in future, precise reasons will have to be given when a medicine is no longer marketed – no one can be in any doubt in this regard – and it is also important that the information is then shared between the Member States competently and accurately so that cases like this do not happen again.
Ms Weisgerber and I have tabled an amendment on a drug facts box going beyond what the Commission has already proposed. I want to emphasise that, when using the English terms, we should talk not of a ‘black box’, but of a ‘drug facts box’. We might well not be dealing with a box that is black, you see. That was, after all, possibly one of the reasons why this proposal, which was tabled by the Commission once before, was rejected in the past. A black box is possibly not the right way to indicate this kind of information. However, we do need to improve the package insert.
A system of drug facts boxes has proven itself in the United States. We still have the problem that our package inserts are too complicated. To put it in a somewhat simplified and exaggerated way: there are two kinds of patients. One group do not read the package inserts at all, as they do not understand anything on them anyway, and throw them away. The other group read the package insert quite carefully, are scared by the many potential side effects and consequently do not take the drug. As a doctor, I have experience of both groups, and it goes without saying that both approaches are wrong. We need collaboration between doctors and patients. When important side effects occur, people need to get in touch with a doctor quickly. However, the drug must be taken as prescribed. With antibiotics in particular, it is important that patients must not stop taking a drug when they feel a little better, as that is how resistance develops.
All this kind of information could be much better presented in a drug facts box than it is on current package inserts and, as I mentioned, this approach has proven itself in the United States. I am therefore very grateful that the Commissioner has promised to include this in further investigations, and I hope that we will soon have a proposal on this that is as precise as possible."@en1
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