Europe continues to battle counterfeiters

Governments, regulators and international agencies continue to defend against counterfeiters; in particular, the European Commission has outlined measures that may help to better regulate pharmaceutical distributors. There is still much work to be done, however, particularly when it comes to counterfeit drugs sold via the internet.
Dec 01, 2009


Faiz Kermani
The European pharmaceutical market is valued at close to $250 billion,1 which represents a lucrative prize for criminal gangs. According to the European Federation of Pharmaceutical Industry Associations (EFPIA), counterfeit products have been found in wholesalers, retail pharmacies and over the internet in nearly all EU member states.2 These illegal products may contain too much, too little or no active ingredient, or they may contain toxic substances.3 As well as endangering lives, counterfeits also reduce patients' confidence in pharmaceutical companies.

The behaviour of counterfeiters changes depending on which market they are targeting. In emerging markets, counterfeiters tend to focus on medicines linked to lifethreatening diseases such as malaria, tuberculosis and HIV; in wealthier countries, however, the focus is usually on new expensive medicines, particularly lifestyle drugs.2

Ironically, the threat faced by Europe has increased as the EU has expanded its boundaries and relaxed border controls to enable the free movement of goods and encourage trade. In 2007, the International Narcotics Control Board, which monitors the implementation of the United Nations' drug control conventions, warned member states to consider the counterfeiting situation as a priority because the rapid expansion of unregulated markets was dramatically worsening the state of affairs.4 In 2007, 4081056 medical products were seized by customs officials at borders — a 56% increase compared with the previous year.5

The scale of the problem

Counterfeiters exploit multiple entry points to introduce fake prescription medicines into the European distribution network. In 2004, the Social Market Foundation warned that the economic disparity between incoming and existing EU member states, combined with historic trade links to former Soviet Union countries where counterfeiting was already a serious problem, would create new risks.6 A number of high-profile cases have illustrated the lengths that criminal organizations will go to, as well as the sophisticated measures they use to gain a European foothold.6

In the UK in 2004, two counterfeiting cases that occurred within a few weeks of each other forced the first recall of branded products since an incident in 1994 involving fake Zantac (ranitidine; Boehringer Ingelheim, Germany).6 Investigations by the UK's Medicines and Healthcare products Regulatory Authority (MHRA) led to batches of Reductil (sibutramine; Abbott Laboratories, USA) and Cialis (tadalafil; Lilly, USA) being recalled. According to the agency, one wholesaler knowingly purchased the counterfeit products. By early 2008, the MHRA had identified 14 incidents of counterfeit medicines entering the supply chain, with nine requiring recalls.5

In 2004, in Spain, police were alerted to illegal shipments of pharmaceuticals in the mail system and made the largest seizure of counterfeit medicines in the country to that date, with the market value of the seized fake products estimated at €6 million.6 The gang behind the operations had received shipments from Eastern Europe and the US, and had set up a local distribution network. In the same year, another police operation destroyed a network of laboratories in the north east of the country that had been manufacturing fake anticancer drugs, among other products. The large-scale operation resulted in approximately 30 million doses and 10 tonnes of tablets being seized, and led to followup raids in 13 other Spanish provinces. Worryingly, an EU-wide distribution network was already in operation using lorries, internet sites and a chain of health stores to circulate the counterfeits. Investigations revealed that a number of the fakes had already been exported to Italy, France and Portugal.