Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-515"
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"en.20100921.18.2-515"2
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"Mr President, I would first like to respond to some of the points raised.
Colleagues talked about transparency: I think that what we have achieved is a big breakthrough in transparency. The amount of information that will be made public through the web portals is a huge increase on what we have already.
On the independence of the work on pharmacovigilance: it was the amendment from this Parliament which has now separated authorisation from pharmacovigilance and makes sure it is the Pharmacovigilance Committee that will make the recommendation, which can only be overturned if there is a very strong reason. So we have done a big job in establishing this independence and improving it.
The Commission: there is a lot of work for the Commission to do after this legislation is approved tomorrow. I think we will achieve a big majority in the House. There is a lot of work to do on the patient information leaflet, with a lot of dissatisfaction from patients’ organisations and from individual patients about it. You tried to find a solution in the Commission. It was not one which found acceptance. But we want to work with you to have a good patient information leaflet.
The leaflet cannot be a repository for every possible thing that can happen to a patient, because that makes the leaflet useless in the eyes of the average patient. It has got to make sense. It has to prioritise information. We need to work with you on that.
You are going to do the study on the environmental impacts of medicine. That is very important, and we want to see the black symbol. We want that symbol developed; we do not want to see it go away, like it did on the medicines for children, the paediatric medicines. We want to see that symbol soon.
For the Member States, an awful lot of work on the web portals has to be done. We want to see these up and running and a timetable for when they are being established. It is vital, as the Commission has said, that people get information in their own language, and the Member States also have to set up their direct reporting systems. It is a lot of work for national agencies.
For the EMA, there will be an increase in work, and we have to resource it properly. We discussed this at length in the negotiations and want to see that happen.
Thank you once again to everybody concerned. I hope we will get a big majority tomorrow and then the real work can start to make a difference, on the ground, to people’s lives."@en1
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