BY OUR PHARMA CORRESPONDENT
18th August,2005: With the confiscation of another batch of fake anti-cholesterol Lipitor pills in the UK, several questions are raised on the security of UK’s drugs supply chain.
At the first week of August, a batch of counterfeit Lipitor was confiscated in one drug store in UK. Following the find, Pfizer-- the producer of this anti-cholesterol drug, had recalled that batch of Lipitor 20mg and the Medicines and Healthcare products Regulatory Agency (MHRA) has ordered a probe to find how a batch of Lipitor 20mg snaked its way onto the UK market. However, another batch of fake 40mg Lipitor pills was caught last week.
The latest batch, which was found when the MHRA was reportedly tipped off by a source in Holland, carried identification numbers that meant it was not for sale in the European Union. Fake Lipitor (40mg) was discovered at a small pharmaceutical wholesaler which, while it had a legal permit to conduct parallel trade, adds fuel to Pfizer's case against the practice of moving drugs around Europe for a profit.
A spokeswoman at the MHRA confirmed that it was also a counterfeit batch and the agency has intensified the investigation.
The agency would not disclose the nature of the find that led it to believe the drugs were fake, and not simply an illegal import, for fear of compromising the ongoing investigation. However, it confirmed that the initial inquiry that was with Pfizer would continue and would “take into account” the new information.
Many are concerned about the breakdown of the supply chain within Europe. With 140 million packs of parallel trade (PT)medicine in circulation in Europe annually, how can one be sure - given the dramatic increase in the number of PT licences - that the system is as safe as it used to be, they ask MHRA.
The drug maker Pfizer squarely blames the PT strongly believing that there is a clear link between disruption to intended distribution routes caused by parallel traders relocating and repackaging drugs, and opportunities for counterfeit products to reach UK wholesalers, and even patients.
“We believe that counterfeit Lipitor entered the UK supply chain through that medicines trading route [parallel trade], so we believe it went from a middle man to a primary wholesaler, and out to pharmacists. It is a typical example of the system breakdown, ” said a Pfizer spokesman recently. He added that the company had a lot of confirming evidence from various investigative agencies, such as the FDA and the FBI, that said you looked for the weakest point and to Pfizer parallel trade seemed like a very weak point to attack the European system.
Some 18 months ago the MHRA went on record saying that the UK has the safest record for counterfeit medicines and the safest supply chain record in Europe, he pointed out.
Lipitor is the world's best-selling pharmaceutical product and earns £6.6bn a year for Pfizer. Obviously, the company doesn’t want its name and brand repute to be put on peril.
The Association of the British Pharmaceutical Industry (ABPI) supports Pfizer’s position highlighting parallel trade and internet pharmacies as two possible weak areas in the system.
However, MHRA spokesman maintained that the Lipitor recall - related to the discovery of the first batch, of 20mg pills - had no direct connection to the practice of parallel trade.
“This 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,” the spokesman 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.
``In the middle of June, one of EAEPC’s 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. Therefore, he noted: “We believe that by opening packs, parallel importers add a layer of safety to the supply chain.”
BY OUR PHARMA CORRESPONDENT