Thursday, October 25, 2012

Faulty medical implants investigation: 'We can help you label it European so China is not on packaging'


Telegraph

Firm tells reporters posing as representatives of hip implant maker how to bend the law.


9:56PM BST 23 Oct 2012


For the female executive from the Hungarian firm which is authorised to approve medical devices throughout Europe, the brochure outlining a proposal for a new “metal-on-metal” hip implant should have rung alarm bells.
 
The two people purporting to be executives from a Chinese firm called “Changi” should politely have been told that such a product could be risky and certification might be a problem.
 
But Anna Szabo, an executive at SGS in Budapest, offered advice on how to “market” the questionable product to unsuspecting patients in Britain and elsewhere. While the product would still need approval, Ms Szabo said: “What we suggest is that you make a certification so that the, on the product itself, the label would be from a Hung- … European country and therefore the Chinese producer will not be on the packaging.”
 
“Why is that a good idea?” asked the person Ms Szabo thought was representing a potentially lucrative client from a Chinese firm, but was, in fact, an undercover reporter from The Daily Telegraph.
 
“This is better from a marketing point of view,” the SGS executive replied. Ms Szabo said they could find someone in Hungary to represent the Chinese company. “The point would be on the packaging of the things … is much better if you have a European kind of origin country,” she said. “It’s much more of a paperwork kind of thing,” she said.

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