Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-10-Speech-1-241-000"
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"en.20120910.29.1-241-000"2
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"Madam President, I would like to start by congratulating the rapporteur, Ms McAvan, warmly for her excellent work once again. Good pharmacovigilance protects the citizens of Europe. At the same time, we are also bolstering informed patients. It was therefore very important to close the safety loopholes exposed and actually opened up by the Mediator case as soon as possible.
From now on, a company that removes a medicinal product from the market must state the reasons why it is doing so. The other Member States will also be informed via the European Medicines Agency – something that is irremissible for the protection of patients in Europe’s internal market, too.
There is one point that is particularly close to my heart, which is the better readability of package inserts. Many patients really do complain about the complexity of package inserts. They say they are too difficult, too hard to understand, too unreadable, too confusing. This is a subject that the older elements of the population in particular bring up, although it is not only them. Some patients are even so scared by the side effects when trying to find important information that, in the end, they do not even take the medicine. Together with Mr Liese, I therefore advocated the idea that the package insert should be made more readable for patients and that a drug facts box containing the most important information, including the side effects, should be included on the package insert, written in plain language and given graphic emphasis.
I am very pleased about the result obtained from the negotiations, and about the fact that the Commission, Commissioner Dalli, has also promised to produce a report on better readability. I hope that the Commission will keep its promise and also that it does so as soon as possible. I would be interested to hear – and I am happy to take the opportunity presented by the presence of Commissioner Dalli with us here today – whether there are already specific ideas in this regard at this point. I would be really interested to hear the answer to that question. I would like to offer my thanks to the Commission for having tackled this issue, as it really does represent a major step towards patient friendliness if we can improve the package insert and make it more readable."@en1
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