Despite receiving increased regulatory attention, counterfeit medicines remain a serious and ongoing global health threat. The World Health Organization (WHO) defines them as medicines that have been deliberately and fraudulently mislabelled with respect to their identity and/or source (1). Such illicit products range from random mixtures of harmless, inactive substances to toxic preparations that can result in death. Counterfeit medicines are found everywhere in the world, although the scale of the problem varies from region to region.
Criminal gangs are attracted to pharmaceuticals because of the high value of medicines and the relatively low risk of prosecution (2); as the counterfeiting business operates on an international scale, it is difficult to tackle the source of the problem and apprehend the parties involved. Furthermore, since many countries have failed to enact deterrent legislation, counterfeiters have felt free to act with impunity and have often managed to evade justice.
European supply chains breachedCounterfeiting has traditionally been most prevalent in regions where the regulatory and enforcement systems for medicines are at their weakest, which includes many African countries, as well as parts of Asia and Latin America. In contrast, counterfeiting levels in most industrialised countries (e.g., EU countries, the US, Australia, New Zealand, Canada and Japan) tend to be low thanks to effective regulatory systems and market control. Consequently, many anticounterfeiting strategies have tended to focus on the areas where counterfeit pharmaceuticals are most prevalent.
However, the supply chains of industrialised regions are now under threat, with several highprofile court cases in 2011 highlighting the efforts that counterfeiters are willing to make to break into high-value pharmaceutical markets. These cases have brought a renewed sense of urgency to the fight against counterfeiters.
In 2011, the Medicines and Healthcare products Regulatory Agency (MHRA) revealed the extent to which the UK is now being targeted by counterfeiters. In one country-wide crackdown, the agency reported that over a million doses of medicines worth approximately €2.4 million were seized in raids by enforcement investigators (3). Counterfeit Valium and Viagra were the most commonly sold fakes, but counterfeiters were also targeting major therapeutic areas such as cancer, cardiovascular disease, respiratory disease and depression.
The MHRA's success against counterfeiters was illustrated by the culmination of a case that has been described as the most serious counterfeit medicine fraud in the EU (4). A criminal gang had attempted to target the UK by bringing in two million doses of counterfeit drugs from China. The plot was highly sophisticated, with the products closely resembling genuine medicines, and was considered the worst breach of the UK's regulated medicines system. Approximately 72000 packs of counterfeit medicines with a retail value of around €5.6 million actually managed to enter the UK supply chain between December 2006 and May 2007. It was only thanks to international cooperation over a tip off that the criminal network was broken up. In May 2007, a licensed pharmaceutical packager in the UK was repacking a wholesale consignment of the antipsychotic drug Zyprexa when he noticed anomalies in the packaging (5). He informed the drug's manufacturer, Eli Lilly, who were suspicious about the findings and immediately contacted the MHRA. The regulator's enforcement team then impounded the consignment. Upon testing, it was found that the fake Zyprexa tablets contained various impurities, as well as only 55–80% of the API (5). This led to the MHRA's first ever Class One Drug Alert recall for the fake batch of Zyprexa as it ordered all pharmacies and healthcare staff to ensure that the product was taken off the shelves. Over the following months, the investigation revealed a complex international supply route that led from Ireland via Belgium and Mauritius, and then to a location in London. At the same time, US investigators began to investigate the matter and revealed the Chinese source of the counterfeits.
Despite this success, the UK's BBC news has recently reported that not all the counterfeit products that entered the country's supply chain have been recovered. Following questioning of the MHRA using a Freedom of Information request, the regulators admitted that although the vast majority of counterfeit products had been recovered, some had been dispensed to patients (6). Eight patients who had received counterfeit Zyprexa or Plavix were identified, but the authorities are continuing to look for other patients who may have received such products. According to the BBC, the numbers could run into the thousands.
There are also continuing reports of other breaches of the system. At the end of last year, the MHRA announced that counterfeit versions of the HIV medicine Viread had been discovered in the UK market alongside earlier-reported Truvada counterfeit products (7). At around the same time, a Danish parallel importer withdrew stocks of Truvada following consultations with the Danish regulatory agency. So far, full details of the nature and source of the products have not been made public and there is no evidence that they reached patients.
Illegal online pharmacies have been a particular problem for the authorities. In November 2011, two men who had been running an illegal online pharmacy business were sentenced to 24 months in prison. The MHRA had run a 2-year surveillance initiative called Operation Aimee to expose the set up (8). Over this period, MHRA intelligence officers made large numbers of online test purchases of products to build up evidence for their case. When raids were finally conducted, 99220 tablets of counterfeit Viagra, Cialis and a number of other controlled substances were seized.
Fortunately, the MHRA were able to expose and close down this particular criminal network, but the consequences of the illegal online trade ended up being deadly for one unfortunate victim. In a tragic case, a young paramedic who was having trouble sleeping between shifts decided to look online to get quick access to medication. She bought an anti-depression drug that is also used for insomnia from an online site, but died after taking a few tablets (3). The case served as a reminder of the fine line between success and failure against the counterfeiters and the need for concerted action.