Curing the ‘sick business’ in fake drugs

By Martin Banks

Date: 20/07/05

THEY are the 'silent killers' - the counterfeit crooks constantly on the look to make a quick profit.

But it isn't just fake jeans, DVDs and perfume that they are manufacturing but something far more dangerous - medicines.

Drugs ranging from paracetamol to antibiotics and anti-malarial pills are increasingly the target of criminals.

The World Health Organisation (WHO) says that up to 10% of medicine on the global market is fake and the illegal trade is worth € 28.9 billion a year. The fake medicines often have no active ingredients or incorrect quantities, which can result in prolonged illness or even death. For as well as being costly for business, counterfeit pharmaceuticals can also be dangerous.

A team of German researchers tested 16 versions of streptokinase, a clot-busting drug used to treat heart attack victims, to see if they contained enough streptokinase to be effective.

They found only three matched European requirements for the safety of medicines. In another recent case, one man in China was dealing in fake Viagra, supplying over 250,000 million pills a month to customers around the world including nine EU countries.

The WHO, which has described fake drug manufacturers as "silent killers", says the problem is most critical in developing countries, where up to 25% of medicine is fake or substandard.

But it isn't just fake jeans, DVDs and perfume that they are manufacturing but something far more dangerous - medicines.

Drugs ranging from paracetamol to antibiotics and anti-malarial pills are increasingly the target of criminals.

The World Health Organisation (WHO) says that up to 10% of medicine on the global market is fake and the illegal trade is worth € 28.9 billion a year. The fake medicines often have no active ingredients or incorrect quantities, which can result in prolonged illness or even death. For as well as being costly for business, counterfeit pharmaceuticals can also be dangerous.

A team of German researchers tested 16 versions of streptokinase, a clot-busting drug used to treat heart attack victims, to see if they contained enough streptokinase to be effective.

They found only three matched European requirements for the safety of medicines. In another recent case, one man in China was dealing in fake Viagra, supplying over 250,000 million pills a month to customers around the world including nine EU countries.

The WHO, which has described fake drug manufacturers as "silent killers", says the problem is most critical in developing countries, where up to 25% of medicine is fake or substandard.

There is evidence of a growing trade in fake medicine, much of it distributed on the internet by operators who are unlicensed and unregulated..

A recent University of London study concluded that half the men buying Viagra online are getting counterfeit tablets. In 2003, counterfeit Viagra with an estimated value of more than € 3.41 million was seized in the UK where fake obesity and impotence pills have also recently been discovered, the first time that counterfeit drugs have found their way into the legitimate supply chain in the UK for ten years.

But a group representing parallel distributors, the European Association of Euro-Pharmaceutical Companies (EAEPC) says it is completely erroneous to link - as some drug companies have - the trade in counterfeit drugs to the one known as 'parallel trade', where drugs made in one country are repackaged for another.

A spokesman for the EAEPC says: "Parallel trade is not an entry point for counterfeiters in Europe and the EAEPC is actively engaged with the industry to find ways to fight counterfeiters. The association resents the attempt to link legal and legitimate parallel distribution to the wholly illegal practice of counterfeiting."

The 70-member EAEPC is among several organisations which will part in an anti-counterfeiting seminar, organised by the Council of Europe, in Strasbourg on 21-23 September.

Ann Robins, legal affairs manager of the Brussels-based European Federation of Pharmaceutical Industries and Associations (EFPIA), says that without knowing what ingredient is in a counterfeit medicine a patient could be putting theirhealth at risk.

She says: "Counterfeit drugs run from the relatively harmless, such as a cough syrup, to the very harmful. A medicine containing impurities, for instance, is obviously potentially very dangerous to someone who may have unwittingly taken it."

Counterfeiters often have links to organised crime, says Graham Satchwell, an expert with the Stockholm Network think-tank and a former British police officer who has dealt with anti-counterfeiting for ten years.

In his book, A Sick Business, Satchwell, also a member of the UK Patent Office investigations strategy group, details the "horrifying" trade in fake medicines and its links with organised crime - and even terrorism.

He says: "Across Europe, counterfeiters have discovered a range of easy routes for selling fake and sub-standard products into the legitimate distribution chain. To the uninitiated eye, this crime is invisible and most patients and consumers are unaware of just how many public safety problems counterfeit medicines may cause."

Satchwell argues that more needs to be done to combat the threat, particularly from Russia and Eastern Europe, which are believed to be the source of many of the fake medicines that find their way onto the European market. He says this trade has already claimed thousands of lives.

In May, the WHO unveiled the first internet-based system for tracking fake drugs in Asia. The Rapid Alert System will transmit reports on the distribution of counterfeit medicine to national health authorities so they can act on the information.

And last week, the European Commission announced plans for a new directive on stricter criminal sanctions for infringement of intellectual property rights, including counterfeit drugs.

"These are very welcome measures which, hopefully, will help deter the people behind this disturbing trade," says Ann Robins.

Article takes a look at the growing trend of trade in fake medicines.