Five-fold increase in drug fakes over 2006

2005 only saw seizures totalling around half a million items, but the figures for 2006 have revealed a hefty increase, causing concern at the European Commission due the potential health and safety risks associated with fake pharmaceuticals.

The most popular targets for counterfeiters over 2006 were Pfizer's blockbuster drug Viagra (sildenafil citrate), Eli Lilly's Cialis (tadalafil) and Bayer's Levitra (vardenafil) - all products for the treatment of erectile dysfunction.

Other medications commonly faked over the past year included anti-cholesterol and osteoporosis drugs and those used to control hypertension.

"The harmful effects of the illicit trade in counterfeit goods are well known," the report from the EC reads.

"The marketing of fake goods does considerable damage to rights holders, as well as law-abiding manufacturers and traders and more and more attention is being drawn to the dangers to the consumers' health and safety."

Despite efforts by the pharmaceutical industry to combat the illegal trade in counterfeit versions of its products and protect supply chains, counterfeiters appear to be slipping through the net and continuing to peddle their fake goods.

The current number one source for counterfeit drugs entering the EU is India, where over 30 per cent of the fakes originate, closely followed by the United Arab Emirates and China.

These three countries combined accounted for over 80 per cent of all counterfeit medicines in Europe.

"The emergence of India in this sector reflects the developing industrial capacity of this nation and highlights the reality that counterfeiting is carried out on an industrial scale, in all sectors where a potential profit is perceived," said the EC report.

Although India was the main culprit for counterfeit pharmaceuticals, some European countries were also to blame, with Norway creeping in at joint sixth position.

Germany was also highlighted by the EC as reporting a staggering increase in counterfeit goods seizures, the total jumping from 15.5 million articles in 2005 to over 140 million articles in 2006.

Maria Assimakopoulou of the Taxation and Customs unit at the European Commission told in-PharmaTechnologist.com that companies needs to communicate with the authorities in order to help combat the spread of counterfeit goods: "In the customs field, we recommend that businesses cooperate with customs authorities by submitting advance information on their products, so that customs officials have enough information to identify counterfeited products," she said.

"Once suspicion exists on products, we recommend businesses to submit declarations for actions to the customs so that seizures can be started."

There are several initiatives being brought on line by the EC which could help fight the trade in counterfeit goods, and may also partly account for the vastly increased haul in fake goods over 2006.

For example, a specific Supply Chain Security Pilot Project is being developed with the aim of tightening end-to-end supply chains between Asia and Europe.

The project will involve data-exchange relating to goods traded between China, the Netherlands and the UK, with particular emphasis being laid on establishing "secure lanes" for sea containers moving between China and main European maritime ports.

As well as this, the EC has been working to further develop its RIF management system to lead to better coordination between EU member states.

"The RIF consists of an electronic exchange of information between customs authorities," explained Assimakopoulou.

"It allows customs authorities to exchange electronic messages once they have detected risks on certain products."

For example, if Belgian customs authorities seize counterfeited goods imported by an 'unknown' importer, the RIF system would allow the information to quickly be relayed to the 26 other EU administrations so that they can focus their attention on the suspicious importer.

With reports of counterfeit drugs cropping up with alarming regularity, these tightened security measures along with EU plans to enforce criminal sanctions on those found guilty of counterfeiting seem to be increasingly necessary.

In under a week there have been reported cases of counterfeit batches of no less than three major drugs - Eli Lilly's antipsychotic Zyprexa (olanzapine) was the first, closely followed by Bristol-Myers Squibb and Sanofi-Aventis' blood clot prevention drug Plavix (clopidogrel), and AstraZeneca's prostate cancer drug Casodex (bicalutamide).

At present, the Medicines and Healthcare products Regulatory Agency (MHRA) are investigating the possibility of links between the three cases, particularly as in all three cases the counterfeit products were packaged in French livery and distributed via parallel trade.

These latest cases will have sparked concern in the European pharmaceutical industry, particularly as the existence of the fakes came to light not through any high-tech security measures but simply vigilance on the part of wholesalers and repackagers who were offered the suspicious packs.

No matter what sophisticated gadgetry is introduced in an effort to protect pharmaceutical supply chains, it would seem that a little human diligence to supplement the technology also goes a long way.