Local view for "http://purl.org/linkedpolitics/eu/plenary/2011-02-16-Speech-3-147-000"
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"en.20110216.11.3-147-000"2
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"Mr President, I voted for this report because the regulatory framework that emerges from it is much better than the one laid down by the 2001 Directive. The latter placed the sole responsibility for compliance with wholesale distributors, thus failing to guarantee the reliability of the pharmaceutical supply chain in any way.
The report we voted on today introduced measures to further ensure the safety of pharmaceutical products such as, for example, the stepping up of inspections of manufacturers outside the European Union on the basis of a risk analysis. The proposed amendment also includes the need to publish in an EU database a list of certified wholesale distributors, in other words distributors for which compliance with EU legislation has not been established through inspection by the Member State alone.
We could nevertheless have hoped for a more ambitious outcome. I refer particularly to the introduction of mandatory inspections of active-ingredient production sites in third countries. These were omitted on the grounds that implementation costs would have been too high. If they had been introduced, we could have avoided the oft repeated situation of European companies having to meet very high quality standards, while companies that produce in other parts of the world benefit from regulatory frameworks that are undoubtedly less stringent. I therefore hope that improvements can be made in the future."@en1
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