10% of EU drug market counterfeit

COUNTERFEIT medicines make up 10% of the total drug market in Europe and the figure is expected to double in the next five years.

Prompted by warnings from the medical industry and police, the Council of Europe and the European Union have began tackling the murky world of illegal medicines, which is worth €28 billion a year.

Fake drugs first appeared in Western countries less than 10 years ago in so-called lifestyle products - bulking up or slimming products. However, recent seizures have included anything from common antibiotics and cholesterol drugs to Viagra and Tamiflu.

The Council of Europe report estimates that up to 10% of drugs on sale in Europe are fake. In some countries this could be as high as 12%.

A recent EU survey found 170 counterfeit medicines on sale, many of them over the internet. Enterprise and Industry Commissioner Gunter Verheugen said he is alarmed at the ever-increasing number of counterfeit medicines sold via the internet.

Part of the problem is that they are increasingly turning up in legitimate outlets too, such as pharmacies. Pfizer’s senior director of European trade, Julian Mount, says the illegal online trade is just part of the story.

“Counterfeits have also made it into the legitimate medicine supply chain in Europe. It is particularly difficult for patients to know if a medicine is counterfeit when it is supplied through trusted sources,” he said.

According to Graham Satchwell whose British company, Proco Solutions, specialises in investigating pharmaceutical fraud, drugs can change hands 20 times before reaching their final destination.

Much of the fake drugs coming into the EU are from Russia, where a fifth of the medicines in circulation are believed to be counterfeit.

Russian criminal gangs are channelling the drugs mainly through the Balkan countries and from there, with virtually no borders to stop them, into the EU.

The German Pharma Health Fund, which has carried out a lot of work in the area, says everything is being counterfeited: active ingredients, dosage forms, package inserts, packaging, manufacturers’ names, batch numbers, expiry dates and documentation relating to supposed quality controls.

They have divided the counterfeits into four types:

* The perfect imitation with proper type and quantity of ingredients that present little risk to consumers.

* Identical packaging but with sub-standard ingredients that do not cure, and in the case of antibiotics allow pathogens to become resistant to antibiotics.

* Looks like the real thing but contains no active ingredient.

* The drug contains harmful or poisonous substances that can lead to injury or death.

There is also the risk that genuine drugs in the wrong hands become dangerous because they have passed their expiry date or have been stored incorrectly.

Criminals need little to develop fake drugs - often access to a small laboratory will do. The internet offers a cheap way of selling them and despite warnings, people do not appear to be aware of the dangers.

Council of Europe deputy secretary general, Maud de Boer-Buquicchio, who chaired a conference on counterfeit medicines recently, said the lack of security was worrying.

“There is no recognised central reference point in Europe entrusted with surveillance, trend analysis and policy recommendations in counterfeit medicines. This situation helps counterfeiters, who can rely on national and international co-operation information gaps. Even when they are caught, they often get away with administrative fines, with no deterrent effect,” she said.

Tackling the problem needs co-operation between a number of bodies, including the Council of Europe, the European Commission, the World Health Organisation and US Food and Drug Administration, she said.

“A counterfeit medicine is not a fake Gucci bag or a poor imitation of Ray-Ban sunglasses, which will cause you well-deserved hassle at the customs. It may well kill you and many others across Europe and the world,” she said.

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