Batches of two fake blockbuster drugs are being recalled after counterfeits made their way into the UK supply chain via parallel distribution, adding fuel to the debate on the security of the practice in the EU.
Three batches of Zyprexa (olanzapine), Eli Lilly's market-leading antipsychotic drug, are being recalled after a repackager of the Zyprexa batches grew suspicious and informed Eli Lilly.
Ongoing investigations of the Zyprexa counterfeiting by the Medicines and Healthcare Products Regulatory Agency (MHRA) led to the recall of two lots of blood clot-reducing Plavix (clopidogrel) from Sanofi-Aventis and Bristol Myers Squibb.
The counterfeiting of both drugs is thought to be related.
According to an MHRA spokesperson, fake Zyprexa and Plavix are the first counterfeit drugs in 10 years to enter the UK supply chain via parallel imports. But despite this rarity, the pharmaceutical industry has often argued that parallel importing could pave the way to a black market in counterfeit drugs.
Parallel trading is not illegal in the EU, and involves medicines being imported from countries where they are cheaper, to be resold and distributed outside the distribution network that the manufacturers or original suppliers have.
For Zyprexa and Plavix, the European Medicines Agency (EMEA) has approved more than 30 UK parallel distributors to supply each product separately.
In both cases, the counterfeit material was supplied in French livery via parallel distributors into the UK supply chain and may be present alongside the genuine manufactured product, the MHRA announced in a statement.
The bootleg Zyprexa contains approximately 60 per cent of the labelled active pharmaceutical ingredient (API), while Plavix contains between 70 and 80 per cent.
While fake Zyprexa reached patients, the MHRA was not aware at this stage how widespread the Plavix tablets were in the supply chain, but was recalling them as a "precautionary move".
One person in relation to the incident has been arrested and is on bail but has not yet been charged.
The MHRA spokesperson told in-PharmaTechnologist.com the agency had made several raids and seized documents but was unable to disclose any information on how the counterfeits got into the parallel distributed supply chain. It is believed the drugs were probably manufactured in either China, India or Pakistan.
Despite the obvious breach in the process of parallel distribution, the MHRA maintained it was "statistically incorrect" to say parallel imports increased the chances of counterfeit drugs making their way into the supply chain.
In 10 years, this was only the seventh time counterfeits had made their way into the UK supply chain and this was the first time via parallel importing, the MHRA spokesperson said.
"There is a risk but we keep an eye on things. This is only one example," she said.
Heinz Kobalt, secretary general of the European Association of Euro-Pharmaceutical Companies (EAEPC), the representative voice of pharmaceutical parallel distribution in Europe, agreed.
"It's too early to draw full conclusions . . . It must be an element of poor checks or oversight or not enough vigilance. It is not a systematic error of parallel trade. It is a one-time incident and I hope it remains a one-time incident," he told in-PharmaTechnologist.com.
Kobalt maintained that despite the cases there was still no argument to say parallel trade in pharmaceuticals needed to end: "The incidence of car accidents doesn't lead to prohibiting cars," he said.
According to the EAEPC website, "parallel trade is extremely safe".
"Exporters and importers both apply internal supply chain controls and must meet stringent external regulatory checks to guarantee patient safety."
It continues: "parallel distributors actually help to add a layer of safety to the distribution chain, often finding defect products".
In the Zyprexa case this is exactly what happened - Eli Lilly was informed by a company which printed labelling for its products, after a repackager became suspicious and contacted them.
But the world's largest drug-maker Pfizer has more than once spoken out against parallel trade in the pharmaceutical industry. Earlier this month, the drug giant attacked the practice during the First European Parliamentary symposium on pharmaceuticals and made reference to the 2006 recall of 120,000 packs of Lipitor (atorvastatin), accusing "middlemen companies" of their part in having counterfeits infiltrating the supply chain. This claim has been refuted by the EAEPC.
Eli Lilly and Sanofi-Aventis were unavailable for comment at time of press.
The batches being recalled are A229505, A200127 and A216454 for Zyprexa and Lots 3098 and 6Y098 for Plavix.
The counterfeit drug business is estimated to grow 13 per cent a year to reach $75bn (€56bn) in 2010, according to market research analysts Gartner and Frost & Sullivan.