Local view for "http://purl.org/linkedpolitics/eu/plenary/2011-02-15-Speech-2-563-000"
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"en.20110215.29.2-563-000"2
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"Madam President, I am very pleased to have this opportunity to address Parliament on this important issue of falsified medicines. The proposal before us today for an amending directive on falsified medicines will, subject to Parliament’s approval, take us into new territory. A successful conclusion of this file will mark the first time that the European Union has tackled, with legislation, the specific threat of falsified pharmaceuticals.
This text is going to make our regulatory system fit for the future; making a major contribution to protecting patients from the many dangers of fake medicines. As Members will know, falsified medicines are different from counterfeit products. Falsified medicines are about public health.
I was very pleased that an early agreement on the substance of the proposal was reached between the colegislators just before Christmas. Let me thank all those who worked so hard to make this agreement possible, especially the rapporteur of the lead committee, Ms Matias, as well as the rapporteurs of the committees giving opinions, Ms Sartori and Ms Bastos. I would also like to thank all the shadow rapporteurs.
The Commission stands fully behind the substance of this well-balanced agreement, which introduces rigid and effective measures whilst being risk proportionate and flexible. This is crucial, as not all medicines are the same: the likeliness of falsification varies, as does the risk of public health.
Turning to some of the specific issues, I would like to highlight the following. On safety features: we saw the risk that Member States might, in future, take divergent approaches on the packaging. This would have led to different levels of protection in the European Union. It would have led to a fragmentation of the European Union market for medicines. I am sure Members will share my satisfaction that we have paved the way towards a European safety feature to identify and thus authenticate a medicine. The Commission has always supported a European approach in this regard.
On active pharmaceutical ingredients: the agreed text strengthens inspections and international cooperation in this field. The Commission and the network of European agencies will work more closely with international partners. Only through such cooperation can we achieve a truly effective system of inspection and enforcement.
The legislation, once adopted, will increase the transparency of actors involved in the distribution of medicines. Finally, Parliament insisted on rules concerning online sales of medicines. I consider that Parliament found a strong, pragmatic solution by focusing on issues of transparency. The argument acknowledges that the rules for pharmacies in the EU vary but, in future, it will be easier for patients throughout the EU to distinguish legal operators from illegal online pharmacies.
President, Members, I trust I can count on your full support as regards the next step in the legislative process towards finalising this worthy and much needed initiative."@en1
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