Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-10-Speech-1-226-000"
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"en.20120910.29.1-226-000"2
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"Madam President, pharmacovigilance is, of course, about the safety of medicines and monitoring medicines on the market for potential side effects. Two years ago, Parliament and the Council signed off a major reform of the European system. We had not expected to be back here tonight updating that legislation before it took effect, but that was before the Mediator case in France, which highlighted potential weaknesses in what we had already agreed.
My big priority in the course of negotiations over the last few weeks has been to strengthen the hand of regulators in the pharmaceutical system and, by doing so, to improve patient safety. Two things struck me when I looked at the Mediator case. Firstly, safety issues had been discussed at the European Medicines Agency on a number of occasions among regulators, but no formal referral had ever been made, and the issue was dropped. The company withdrew the medicine from markets in some countries for commercial reasons. The second issue which struck me was that the French and Italian authorities had requested a safety study from Servier back in 2000 because of these concerns, but that study was not finished until almost a decade later. By that time, the medicine had been withdrawn because of the vigilance of a regional pharmacovigilance expert in France.
So, when we looked at the revision, we made several key changes. The first is that, in future, companies will be under much more scrutiny when they voluntarily withdraw a medicine from the market anywhere in the world: this must be reported to the EMA and questions can be asked. Secondly, whenever there is any concern about safety, there will now be an automatic trigger which will lead to an investigation at European level. There will not be national discretion over that decision. Thirdly, when a post-authorisation safety study is requested, that study will have to be carried out. Drugs which are subject to a study will now be labelled with a black triangle so that health professionals and the public know that drug is subject to a post-authorisation safety study. What struck me about the French case was that the French regulator said that it did not have the powers to actually make a post-authorisation safety study happen. This cannot be allowed to happen again.
Commissioner, two outstanding issues came up during the course of negotiations which MEPs hope you will comment on tonight. The first was the issue of fee regulation for the EMA. We need enough money to be able to carry out our pharmacovigilance work properly. The second is the issue of the black box of essential information on the patient information leaflet. You have sent me a letter about these matters and I know that you say that the Commission will look very carefully at both these issues. I hope you will make a comment on this.
Finally, I should like to thank all the shadow rapporteurs who are here this evening for the all the hard work they have put in on this dossier. I thank the Danish Presidency, the Commission and the Council Presidency. The Council Presidency helped us expedite the work quickly so that we could reach an agreement before the summer so that it takes effect at the same time as the other changes to the pharmacovigilance legislation."@en1
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