Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-506"
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"en.20100921.18.2-506"2
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"Mr President, I would like to come back to the environmental impact of medicinal products.
Since 1965, Europe has established criteria for obtaining marketing authorisations. There are three criteria, namely efficacy, safety and the pharmaceutical quality of the medicinal product, but there is nothing about the environmental impact of medicinal products. As you know, the oestrogen found in river waters is changing the sex of fish. As you also know, there are high levels of residues of medicinal products in purification plants and in waste water from hospitals.
There has been a fair amount of discussion on this matter; a debate has been held and, in the Pharmacovigilance Directive, it has finally been taken into account in the form of a recital calling on the Commission to publish a report, on the basis of data provided by the European Medicines Agency, the Environment Agency and the Member States, on the scale of the problem and an assessment of whether or not it would be appropriate or useful to amend EU legislation on medicinal products or in other areas.
What I want of the Commission is a proper report based on these data, because this indirectly affects human health in that, in numerous cases, it is the consumption of water that caused the side effects identified."@en1
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