Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-10-Speech-1-240-000"
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"en.20120910.29.1-240-000"2
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"Madam President, Commissioner, ladies and gentlemen, I should like to congratulate the rapporteur, but also Commissioner Dalli on his responsiveness with regard to the Mediator case. His ability to respond swiftly enabled stress tests to be carried out on the legislation we have just adopted concerning pharmacovigilance in order to identify additional lessons which needed to be learned in the light of the Mediator case.
However, experience has shown that there were weaknesses in our legislation. Today, we are providing solutions to the various weaknesses we have identified. In so doing, we are increasing transparency and strengthening communication with regard to the safety of medicines.
Nevertheless, I think that one weakness remains. Regrettably, this new legislation does not address the central issue of off-label prescriptions, which, in fact, represent 15% to 20% of all prescriptions, or indeed more in certain areas (including paediatrics, psychiatry and cancer research). Indeed, doctors may prescribe off-label medicines when other solutions for the treatment of a given disease are limited or non-existent.
Prescribing such medicines may be useful but it is not without danger, as it is carried out without any form of validation by the health authorities. Most importantly, in terms of pharmacovigilance, it gives rise to very little feedback on adverse reactions by health care professionals, who were afraid that such information would establish their liability.
It is a shame that my proposal, drafted with my colleague, Ms Ries, to mandate the European Medicines Agency (EMA), in partnership with the relevant national authorities, to develop guidelines on this point was not adopted in the final compromise. Stricter control of this type of prescription would enable a balance to be maintained between the need to prevent the unauthorised use of medicines and the need to fill gaps in treatment to meet special medical needs.
I will end by saying that Mediator was often used, in one out of five cases, off-label. I think that it is essential to demonstrate vigilance in this regard and I await Commissioner Dalli’s response."@en1
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