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
