Novartis, minister launch inquiries

Posted on April 11, 2013. Filed under: Uncategorized |

April 12, 2013

Linton Besser, Nicky Phillips

Internal Investigation: Novartis Pharmaceuticals.Internal investigation: Novartis Pharmaceuticals. Photo: Peter Rae

Global drug giant Novartis has begun an ”internal investigation” into a five-year deal it signed with a CSIRO spin-off company to buy an anti-counterfeit technology that the CSIRO and its partner knew could be compromised.

Novartis bought what it was told was a custom-designed invisible ”tracer” that would protect millions of ampoules of injectible Voltaren, widely sold overseas but not in Australia, from the threat of the booming black market trade in counterfeit medicines.

But a Herald investigation revealed on Thursday that DataTrace DNA Pty Ltd, a joint venture between the CSIRO and public company DataDot Technology Ltd, instead issued Novartis with widely available tracer material it had bought from China and which it was warned was insufficient for a pharmaceutical application.

Science Minister Don Farrell has demanded the CSIRO investigate the issue and report back to him, and opposition science spokeswoman Sophie Mirabella is calling for an independent inquiry into the CSIRO to address this ”very serious allegation”.

”There needs to be an independent investigation,” she said. ”Obviously something has gone very wrong.”

Alexandra Suvajac, a Novartis Australia spokeswoman, said the company had several measures to ensure the safe use of its drugs that were ”not compromised by the allegations around the use of this technology”.

”I can confirm we are undertaking an internal investigation of the matter,” she said.

”Novartis is aware of the story reported today and cannot comment further on the ongoing investigation.”

The CSIRO said it was ”making inquiries to establish the facts and test the veracity of the claims in so far as they relate to CSIRO”.

Shares in DataDot Technology have been put into a trading halt until Monday. Company secretary Graham Loughlin requested the halt as a result of Thursday’s press coverage of the allegations.

DataTrace was half-owned by CSIRO when it sold the anti-counterfeit technology to Novartis, which had sought a method to protect its injectible drugs, made in Egypt, Slovakia and Switzerland.

DataTrace had several times assured Novartis the tracer was made under secure conditions in a CSIRO laboratory in Melbourne.

In fact, the company issued it with phosphor-based tracer bought from a lighting supplier in China that was considered sufficient only for low-security applications, such as batch and stock control or sorting industrial commodities.

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