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Lipitor fakes came from 'organised crime'

In the wake of the latest counterfeit medicines scare, parallel traders have poured cold water over industry suggestions that the European pharmaceutical supply chain needs to be tightened

Parallel traders have poured cold water over industry suggestions that the European pharmaceutical supply chain needs to be tightened in the wake of the latest counterfeit medicines scare.

Packs of Pfizer's anti-cholesterol blockbuster, Lipitor, were recalled after UK authorities discovered counterfeit tablets of the drug had entered the legitimate supply chain.

The Medicines and Healthcare products Regulatory Agency (MHRA) said that a batch of the 20mg dose of Lipitor had been seized at an undisclosed location. It added that initial tests of the counterfeit drugs indicated that they did not pose an immediate risk to patients.

Kate Lloyd, medical director at Pfizer UK said the company was ìseriously alarmedî at the incident.

The company added that the British government should consider outlawing the repackaging of original manufacturers' medicines by third parties, a well-known practice in parallel trade. It has also called for the introduction of tamper-resistant medicines packaging and a standardised European barcode system for medicines, to enhance safe recall and identification.

ìPatient safety is at risk if counterfeit products can easily be introduced into the supply chain through cross border trade, as patients will not gain the benefits their doctor intended when taking their medicine,î Lloyd added.

Meanwhile, in a statement, the Association of the British Pharmaceutical Industry Association (ABPI) highlighted parallel trade and internet pharmacies as `two possible weak areas in the systemî.

However, MHRA spokesman Stephen Hallworth confirmed that the Lipitor recall had no connection to the practice of parallel trade.

ìThis is all about organised crime and, as part of our investigation, we're trying to find out how these criminals penetrated the legitimate medicines supply chain,î he said.

Heinz Kobelt, secretary-general of the European Association of Euro-Pharmaceutical Companies (EAEPC) representing parallel traders said there was no evidence of any safety issue on the parallel distribution chain.

ìIn the middle of June, one of our British members came across a box of original Pfizer Lipitor which had neither a batch number nor an expiration date on its outer package - it was fished out from a Portuguese importer.î Therefore, he noted: ìWe believe that by opening packs, parallel importers add a layer of safety to the supply chain.î

While the MHRA said it had taken note of Pfizer's proposals, it reiterated that it already had effective and comprehensive measures in place to tackle counterfeit medicines.

ìClearly no system is perfect and we can't say that this will never happen again but the MHRA remains at the forefront of international regulatory agencies and, due to the safeguards we have in place, the UK legitimate supply is difficult to penetrate with counterfeit medicines,î Hallworth noted.

30th September 2008

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