Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-496"
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"en.20100921.18.2-496"2
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"Mr President, Commissioner, ladies and gentlemen, pharmacovigilance, which involves analysing the side effects of medicinal products and calling for their withdrawal from the market in the event of an alert, incited little interest in the midst of the pharmaceutical package. It is, however, essential to the safety and quality of our health systems and, even though I am delighted to see you, Commissioner, I must deplore Mr Dalli’s absence.
I was dismayed by the Commission’s proposals, which jeopardised the pharmacovigilance systems for the benefit of the pharmaceutical companies. Fortunately, thanks to the work of Parliament and the Council, the situation has been improved somewhat. Thus, it will not be possible to generalise advance marketing authorisations for new medicinal products. We can also be pleased with the progress made in terms of transparency.
However, I think that this agreement represents a missed opportunity to improve pharmacovigilance and I am concerned, above all, at the lack of guarantees regarding the independence of the system. Thus, even though the role of the Pharmacovigilance Risk Assessment Committee has been strengthened, it is not totally independent of the European committee which grants the marketing authorisation. We know from experience that this committee is loath to go back on its decisions. As for national structures, there is absolutely no provision on the matter. Also, I am sorry that the Member States do not have to report possible conflicts of interest of experts on the European committee.
Finally, and this is the most serious point, this agreement endorses the end of the best guarantee of independence: public funding for pharmacovigilance activities, most of which will be funded in future by private fees.
I congratulate Mrs McAvan on having improved the Commission’s initial proposal but, as there are a number of problematic issues, I question the point of closing this dossier in a single reading. If we had taken our time, we could have increased patients’ confidence in safe, high quality pharmaceutical products."@en1
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