Weak links in fragmented global supply chains allow counterfeiters of pharmaceuticals to succeed. This chapter analyses the nature of the fake pharmaceutical supply chain and describes the elements which allow this trade to go largely undetected. This includes a focus on the modes of transport chosen (small packets sent by post), and the sales channels – including the growing role of the Internet. Finally, it explores the role of free trade zones in helping counterfeiters to disguise their activities.
Trade in Counterfeit Pharmaceutical Products
Abstract
Counterfeiters of pharmaceuticals succeed in large part by exploiting weaknesses in supply chains, which are often fragmented (OECD, 2016). Medicines are prescribed by physicians who rarely come into contact with the medicines, and are delivered by pharmacists who commonly source from multiple wholesalers (Lybecker, 2008). In the United States, 90% of medicines are distributed by five major wholesalers. The remaining 10% comprise some 7 000 secondary wholesalers which specialise in purchasing and selling selected discounted products (OECD, 2016; Lybecker, 2008). The secondary suppliers fill demand in cases of spot shortages and also serve as an additional source of revenue for the primary wholesalers through pharmaceutical trading (OECD, 2016). The loosely regulated secondary suppliers purchase excess stock from wholesalers, pharmacies and sometimes unscrupulous brokers. The products are then re-sold to other large distributors or retailers (UNICRI, 2012). The secondary distributors acquire drugs at reduced prices derived from surpluses in production or storage on the part of producers or large distributors and pharmacies. Their small size allows them to exploit changes in the market and to concentrate on specific drugs that exhibit high demand at specific times and in specific areas.
Problems can arise when original pharmaceutical products cross the borders of various countries and numerous importers, retailers and distributors become involved (UNICRI, 2012). The repackaging that takes place throughout the distribution and shipment process offers opportunities for introducing counterfeit medicines into supply channels. The continuous change of hands can mask the provenance of counterfeit medicines, making tracing almost impossible and making it hard to identify who is making the counterfeit drugs. Repackaging can undermine the integrity of the products concerned, effectively foiling anti-counterfeiting mechanisms, such as product tracking mechanisms, used by the manufacturer of the genuine products. The counterfeiters disguised the activity by splitting the consignment, sending blister packs of tablets in one box and flat-packed cartons in which the blisters were to be packaged in another. Both were labelled as containing mobile phone covers, which was the case; the falsified tablets and packaging were buried underneath the phone covers. The seized medicine contained no active ingredient. Industry sources also indicate that counterfeiters engage in deceptive practices, marketing generic products as products manufactured by the original proprietary manufacturer. They are also known to remove and sell legitimate products from genuine packaging and replacing the products with counterfeit items. The legitimate products are then sold on grey markets.
Mail and courier services are the main modes of transport for counterfeit pharmaceuticals traded worldwide, with their shares growing between 2011 and 2016 (Figure 5.1). In terms of volume, air is also an important means of transport in the global trade of fake pharmaceuticals. In terms of value, sea was the main transport mode for fake medicines and pharmaceutical products during 2011-2013, but was replaced by road transport and mail and postal services during 2014-2016.
Source: OECD/EUIPO database.
In 2014-2016, mail, postal services and express services were the main modes of transport for counterfeit pharmaceutical goods and medicines exported to EU economies, both in terms of value and volume (Figure 5.2). This was also the case for 2011-2013, and confirms the persistence of the problem of small parcels in the global trade in counterfeit goods (see OECD, 2018b).
Source: OECD/EUIPO database.
The challenges of small parcels
The growing use by counterfeiters and other illicit traders of small shipments to cloak their activities has garnered increased attention (OECD/EUIPO, 2018b). Between 2014 and 2016, almost 57% of seizures of all product categories worldwide concerned postal shipments and 12% express courier. Air transport and sea transport followed, with slightly more than 15% and 10% of seizures respectively (OECD/EUIPO, 2019). Together, small parcels carried either by postal or express services account for 69% of customs seizures of IP-infringing products for the 2014-16 period, compared to 63% for the 2011-13 period (OECD/EUIPO, 2019).
The preference for using the post to send fake products in many instances reflects the fact that while the risk of detection may be low in sea transport, when interdiction occurs, losses on confiscated cargoes can be very large (OECD/EUIPO, 2018b). Small shipments, however, allow counterfeiters to lower the potential losses that result from the discovery of an illicit trade movement as the ability to avoid detection is considerably higher, and only small volumes are confiscated each time.
The attractiveness of small shipments for counterfeiters has increased over time, benefitting from the explosive growth in e-commerce, and the accompanying rise in cross-border transactions by business and, even more importantly, consumers (OECD/EUIPO, 2018b). The sharp increase in items shipped directly to consumers by parcel post or letter packets has, in effect, ballooned the volume of legitimate trade, flooding the market with a growing number of items. The small shipments are handled primarily by postal authorities and express mail companies, with the active support of retail platforms such as Alibaba, Amazon and eBay. The large growth in legitimate trade in effect has likely made it more difficult to detect the illicit trade. The use of small parcels is well suited to counterfeiters of pharmaceutical products, as shipments of these products can be quite small, easily fitting in bubble wrap letter packets, as well as small parcel boxes.
The challenges posed by the growing volume of items have been significantly increased for the customs authorities responsible for handling items as they cross borders. The information that is available through ship manifests and the like, and the supporting role of customs brokers are absent in small volume trade (OECD/EUIPO, 2018b). In the case of small volume trade involving postal authorities, for example, only simplified documentation is required when items are sent. The information contained on the documents is certified by the sender, and is not typically verified, creating broad scope for both legitimate errors as well as fraud. Moreover, the customs information on postal forms is generally provided in paper form; and therefore not available electronically. In any case, it is generally only available to customs authorities in destination countries at the time a shipment arrives.
This creates a dilemma for customs as checking for suspicious imports has to be counterbalanced with the need for fast processing of all imports. A close review of so many small packages would cause unacceptable delays, and, given the difficulty in identifying counterfeit items, their low value (if contained in parcels or packets) and the relatively small share that they are likely to represent in total trade, the exercise would not be cost-effective. Efforts are being made to enhance the use of electronic forms in the post, in order to provide information to customs in destination countries in advance of arrival of shipments. This would facilitate risk assessment, which relies critically on data and other information to be successful. Problems associated with incomplete, misleading, incorrect or fraudulent information, however, would remain.
In the United States the STOP Act, enacted in October 2018, requires foreign postal authorities to provide advance electronic data (AED) on all packages or packets (under 2 kg) containing goods sent to the United States. The required data include the sender’s name and address, the recipient’s full name, weight and value of the package and its contents. The US Postal Service collects the data from the originating postal operator and passes it on to Customs and Border Protection (CBP) in order to help the CBP to better monitor and target goods moving by mail. Most foreign postal operators were obliged to transmit AED on up to 70% of packages by the end of 2018, though the rate for China, Hong Kong and Macau was 100%. All postal authorities will have to do so for 100% of packages by January 2021. In addition, in April 2019, the Federal Drug Administration (FDA) and CBP signed an agreement to maximise inspection and detection capabilities in order to prevent illegal and harmful products – such as unapproved fentanyl products, counterfeit prescription drugs and fake over-the-counter (i.e. non-prescription) medicines that look legitimate – from entering the United States through the nation’s international mail facilities (IMFs) and ports of entry.1 The two agencies will expand how information is shared to better identify trends which can target future entries. In fiscal year 2018, FDA staff posted at the IMFs around the country examined packages from more than 180 countries. Approximately 90% of the packages screened by the agency contained products that should not have been entering the country.
In the United Kingdom, since 1 January 2019 the Royal Mail has required shippers to provide electronic customs data when sending items (other than correspondence) to destinations outside the European Union (OECD/EUIPO, 2018b). The action was taken to make sure emerging and future legislative, security and customs requirements in overseas destinations would be met.
The situation with express companies is better, as the companies involved generally provide door-to-door services that are tracked and traced electronically. In these cases, other information – on the shipper, product and receiving party – is collected electronically, providing a potentially rich data source that, if available to customs authorities, would greatly assist in risk assessment. Co-operation on this front has advanced as express service providers and customs are working together to improve data and information exchanges. However, it appears that there is considerable scope for improvement as there are, among other things, privacy issues to be addressed, along with confidentiality concerns. As with postal transactions, there may be issues concerning the quality of the information as it is generally based on information provided by the sending party, providing scope for errors and, more importantly, deliberate misrepresentations or fraud.
The attractiveness of small shipments for bad actors is also affected by the special treatment that such shipments have been accorded for customs and tax. Under WTO trade facilitation, countries have established de minimis levels on imports, below which tariffs and taxes would not be collected. The existence and level of thresholds have a number of benefits: for governments, they reduce the scope of the imported items that need to be processed, freeing up resources for other work; for businesses and consumers, they simplify the importation of goods, lowering their cost. On the other hand, the reduced customs surveillance that occurs for items that are exempt from tariffs and taxes could also benefit parties involved in IP crime, allowing them to operate below the radar.
The challenge of tackling imports of small packages containing counterfeit and other illicit items is mounting. In the case of the United States alone, the volume of parcels and letter packets reached 498 million in 2017, with more than 60% entering in the form of packets. With e-commerce expected to continue to grow rapidly, the complexity of handling a growing number of potentially mislabelled shipments will grow.
The growing role of the Internet
The Internet is providing an increasingly viable option for distributing pharmaceutical products – both legitimate and counterfeit – to domestic and international consumers. The ability of sellers to hide their identity and misrepresent their products is particularly attractive to counterfeiters, providing criminals with a relatively easy point of entry into even the best regulated markets (WHO, 2017b). There are two distinct areas to purchase counterfeit pharmaceuticals online: the dark web and the freely accessible surface web.
The pharmaceuticals marketed on the surface web are mainly substance, for which legal controls differ between jurisdictions (Koenraadt and van de Ven, 2018). A 2016 study estimated the number of online pharmacies to be in the order of 30 000 to 35 000 in 2015, with an additional 600 launching every month (LegitScript, 2016). These pharmacies are serving a growing number of consumers. Surveys carried out in the United States, for example, show that the number of people buying medicines online more than quadrupled in less than a decade, rising to between 19 and 26 million people (WHO, 2017b). Based on a survey conducted in the Netherlands, (Koenraadt and van de Ven, 2018) estimate that approximately 10% of the Dutch population buys or has bought medicines online. Painkillers dominate the list of the most popular purchases (31.8%), followed by weight-loss pharmaceuticals (27%), sedatives and tranquillisers (14.2%) and sexual enhancers (14%). Financial motives, convenience and discretion were cited as the main motives for buying pharmaceuticals online (Koenraadt and van de Ven, 2018).
A 2017 survey of US consumers (ASOP Global, 2017) revealed that:
Some 27% of respondents were very familiar with online pharmacies, while one-third were not familiar. Only 5% of respondents were familiar with available Internet resources to identify safe online pharmacies.
One-third of respondents had used an online pharmacy to purchase medications for themselves or someone under their care. Of those individuals, 90% did not consult their healthcare provider prior to purchase. Those most likely to use the pharmacies were young, upper-income individuals.
Some 40% of respondents mentioned price as a reason for using online pharmacies; another third indicated that there were insurance issues.
Two in five respondents did not use online pharmacies, while a quarter of consumers did not think it was a good idea to purchase medicines online.
A majority of respondents (55%) have or would consider purchasing at least one type of prescription or over-the-counter medication online.
Some 11% of respondents were likely to use a Canadian online pharmacy. Interestingly, the FDA has reported that 85% of medicines that are sold to Americans by Canadian online pharmacies are not Canadian.
These statistics are echoed by recent data collected by the Alliance for Online Pharmacy in the EU (ASOP EU) from an online survey following a five country online educational campaign (France, Germany, Italy, Spain and the United Kingdom). Consolidated data (which varied from country to country) indicated that depending on the country, between 35% and 58% of respondents had bought medicine online. Importantly, between 35% and 65% of customers were not aware that most websites selling medicines online are operating illegally.
The LegitScript study referenced above indicated that 97% of online pharmacies failed to adhere to applicable legal requirements, and 92% of those operating illegally were doing so in a blatantly illicit manner (LegitScript, 2016). The United States was found to be far and away the primary focus of the illegal online drug industry, with 82% of Internet pharmacies in English and a similar percentage, 85%, targeting US consumers and offering shipment to the United States. A review of the movement of goods in 29 test purchases revealed that 100% of shipments were carried out using the post; none used courier services. The vast majority of products came from India, with Germany, Singapore, the United States, Canada and the United Kingdom also mentioned. The original source of the pharmaceuticals, however, could not be discerned. Other findings of the report include:
None of the test buys that crossed borders were flagged by customs.
Advertisements for illegal websites represented a tiny share of total online advertisements; those that were posted disappeared and never reappeared.
The illegal online pharmacies avoided registering their domain names with registrars that enforced policies prohibiting illegal online pharmacies. Approximately 45%-52% of illicit online pharmacies were with 10 domain name registrars that either did not have, or did not adequately enforce, policies prohibiting illegal prescription drug sales.
All five of the major payment networks operate rigorous programmes designed to prevent purchases related to illegal online drug sellers. Illicit pharmacies, however, often did not identify themselves as selling prescription drugs to inquiring banks and were usually coded as selling other types of products, thereby undermining the payment providers’ efforts.
As criminals seek to expand the use of the Internet they are now using all types of platforms including social media to reach their audiences
The counterfeiters often promote their business through direct solicitations to potential customers using email and online advertising. The most popular medicines for sale online are so-called “lifestyle” medicines (EAASM, 2008). At the same time, counterfeiters are taking advantage of a rising “self-prescribing culture” on the part of individuals. Moreover, online purchases can appeal to consumers because of 1) the speed and convenience of purchases; 2) the possible lower cost of products; 3) the ability to avoid discussing sensitive conditions with healthcare professionals, family or employer/authorities; and 4) the frequent absence of a need for a prescription.
According to the pharmaceutical company Pfizer, over the 2015-18 period, more than 10 000 Facebook accounts or profiles selling counterfeit Pfizer medications were identified and reported (Reddy, 2018). Moreover, they referred more than 1 000 Instagram accounts selling counterfeit Pfizer products between April and October 2018 to Facebook, Instagram’s parent company. The company notes it is working to find and remove drug sales by blocking and filtering terms associated with them, and it quickly shuts down suspicious accounts that people report to them. It is also working on developing new technology to identify when someone is trying to sell drugs. Pfizer also reported that in 2017, authorities from 49 countries seized more than 12 million counterfeit doses of Pfizer products. More than 5 000 vendors were advertising Xanax for sale on the dark web. The company conducted a pilot programme with law enforcement and bought 138 Xanax samples on the dark web; they tested them and found only seven, or 5%, were authentic. The Pharmaceutical Security Institute reports that it receives roughly 15 000 to 17 000 cases of counterfeit drugs reported globally from its members, which include security directors from 35 pharmaceutical companies. The number of new reported cases was 1 178 from 134 countries in 2017, up 7% from 2016. The bulk of counterfeits appear to be from China, India and the United States.
The scale of online counterfeit trade has been assessed by a number of organisations. The WHO has estimated that over half of medicines purchased over the Internet from illegal sites that conceal their physical address are counterfeit.2 A 2008 report by the European Alliance for Access to Safe Medicines concludes that (EAASM, 2008):
62% of medicines purchased online during the study were fake or substandard
95.6% of online pharmacies researched were operating illegally
94% of websites did not have a named, verifiable pharmacist
84.5% of online pharmacies were virtual (i.e. did not operate brick and mortar establishments)
78.8% of the sites appeared to be violating trademarks
90.3% of websites supplied prescription-only medicines without a prescription.
The experts analysing purchases of online pharmaceuticals to determine their authenticity noted that the vast majority of consumers were unlikely to be able to detect counterfeit products on their own (EAASM, 2008). They concluded that while some counterfeiters made efforts to ship products in ways which would deceive consumers, others did not; the latter shipped products in the wrong packaging, with incorrect or poorly copied manufacturer or product logos or unorthodox box size. A few of the products were shipped merely as loose tablets wrapped inside several sheets of newspaper, while others were delivered in envelopes or paper folded over to form an insecure, make-shift packet. One delivery was simply an envelope containing some loose, unidentified tablets inside a small transparent plastic bag.
According to the EAASM, there is evidence that counterfeiters have used Oceania and the Bahamas as an intermediate destination for fake medicines sent from China and the Middle East (EAASM, 2008). From there, the products are distributed to Europe and other regions via online traders masquerading as legitimate pharmacies based in Europe, the United States and Canada.
A report prepared by the National Association of Boards of Pharmacy (NABP) summarises research carried out during 2019 which identified more than 11 500 online pharmacies that could not be recommended by the association (NABP, 2019). Nearly a third of these pharmacies offered or facilitated the sale of opioids or other. Many of the online pharmacies did not list an address; these pharmacies were most likely to be selling counterfeit products.
The challenge is illustrated further by a simple web search carried out on a popular lifestyle medicine, which returned 147 million results in 0.38 seconds. The overwhelming majority of sites were believed to be from unregistered pharmacies (ASOP EU, 2013). To gain insights into the return on counterfeit sales, a project was launched by the EAASM, which involved setting up a bogus online pharmacy in Germany (EAASM, 2012). Over a nine-week period in 2011, the site attracted 360 532 visitors, of whom 182 602 were unique, from 112 countries. Pay-per-click (PPC), in which the web host pays the search engine a fee for each click, proved to be the most effective way to attract traffic (responsible for 95% of visits), followed by email advertising (4%) and banner advertising (sponsored visual advertisement placed on selected websites) (1%). The study concluded that had the website been actually trading, it would have netted EUR 12-35 million per year.
The involvement of criminal organisations in illicit pharmacies has been demonstrated on a number of occasions (Guerra and Mackey, 2017). In 2007, US federal law enforcement charged 18 members of the Affpower organisation for operating an online pharmaceutical distribution network involving domestic and foreign entities. The organisation included 1) merchant websites for the purchase of drugs; 2) affiliated websites that marketed and promoted sales; 3) a network of physicians who issued prescriptions for the pharmaceuticals; (4) a network of pharmacies that dispensed the drugs; and (5) credit card processors to process the sales. Affpower's administrative headquarters and customer service department were located in Costa Rica while servers that hosted merchant websites were located in Cyprus.3 The owner and operator of Affpower resided in the United States but had bank accounts in Panama, Cyprus and Costa Rica, which were used to further the illegal activity. Affpower used a credit card processor in Israel and bank accounts and an accounting firm in Cyprus. The company recruited licensed physicians throughout the United States and Puerto Rico to review and approve orders for prescriptions illegally. The global operation generated over 1 million prescription orders in two years, generating more than USD 126 million. Similar operations were carried out by the Bansal organisation, which sold more than 11 million prescription pills to more than 60 000 purchasers in the United States, grossing at least USD 8 million in just over a year. The Juan Gallinal network set up sham corporations and used a server in Switzerland. The network made approximately USD 9.8 million over a three-year period.
Street markets
In some developing countries, street markets are often used to sell medicines. The uncontrolled nature of such sales enables counterfeiters to engage in illicit trade with low risk of detection. In Ghana, for example, drug inspectors found tablets purporting to be antimalarial medicines in a rural dispensary (WHO, 2017b). The tablets contained less than 2% of the expected active ingredients. The dispensary had purchased the medicines from a licensed wholesaler, who had, in turn purchased the falsified medicines at a discounted price from a travelling salesman, who was selling the product cheaply from the back of a truck. The wholesaler apparently did not question the legitimacy of the product, which was accepted without any paperwork.
Originally established hundreds of years ago as means to facilitate goods in transit by relieving traders of many customs formalities that would otherwise apply to goods entering into a country for consumption, free trade zones (FTZs) have evolved and developed into an important tool for attracting foreign investment and promoting economic development and growth, particularly in developing countries (OECD/EUIPO, 2018a). The number of zones has expanded rapidly through the years, rising from 79 zones located in 25 economies in 1975 to over 3 500 zones in 130 countries in recent years. For businesses, zones provide numerous benefits; these can include savings in taxes and customs duties; labour and immigration rules that are more flexible than those applicable in the customs territory of host countries; lighter regulation and oversight of corporate activities; fewer restrictions on corporate activities; and opportunities to improve the distribution of goods to diverse markets.
Lightly regulated zones are, however, also attractive to parties engaged in illegal and criminal activities. These zones have facilitated trade in counterfeit products, smuggling and money laundering, often providing bad actors a relatively safe environment for carrying out their illicit activities. The problem is aggravated in instances where governments do not police zones adequately; this can occur when zones are deemed to be foreign entities that are outside the scope of domestic policing activities. It can be further aggravated when zones are operated by private parties. These parties’ main interests are likely to be in finding ways to expand zone occupancy and provide profitable services to zone businesses. They may therefore have little direct interest and/or capacity in law enforcement, nor may they have the capacity or authority for scrutinising zone operations. Even where government authorities are actively involved in overseeing zone activities, there is evidence that co-ordination between these authorities and zone operators, particularly those that are private parties, can be weak, providing further scope for bad actors to exploit zones for their illicit activities.
As noted by the WCO, FTZs are a very important element in global value chains (WCO, 2018). However, from the supply chain security perspective, they still largely remain outside customs control and supervision; there are in fact not many customs administrations that have a mandate to enforce law within the zones.
An example of how zones have been used to facilitate trade in counterfeit pharmaceuticals is found in a 2006 case involving a number of countries (ICC, 2013). In May 2006, UK customs agents seized eight pharmaceutical products, seven of which were counterfeit. The products included infringements involving products made by Merck, Novartis, AstraZeneca, Pfizer and Procter & Gamble (Bogdanich, 2007). The shipment was in transit from the Oyster Corporation, established in the Sharjah FTZ, Dubai, to Personal Touch Pharmacy, established in the FTZ of Freeport, Bahamas (ICC, 2013). A search warrant by the Royal Bahamas Police Drug Unit resulted in the seizure of several counterfeit drugs and uncovered a fulfilment centre for Internet drug orders placed with an illegal on-line pharmacy based in Canada.
The day after the raid in the Bahamas, suspect pharmaceuticals stored in the Sharjah FTZ were moved to an unrelated facility in the Jebel Ali Free Zone in Dubai, in an attempt to avoid further detection. The investigation would eventually unravel a complex supply chain of fake drugs that ran from China through Hong Kong, the United Arab Emirates, UK, and the Bahamas, ultimately to be sold online to customers as Canadian medicines. The Bahamas served as the place where prescriptions were filled and packaged (Bogdanich, 2007). The products would then be sent to the United Kingdom for final shipment to customers in the United States, with the UK postage intended to enhance the credibility of the products. Individuals were charged and, in some cases, imprisoned in the three areas involved: Dubai, Bahamas and Canada. In the case of Canada, the owner of the online pharmacy involved was eventually sentenced to four years in prison in 2013, when 90% of one shipment was found to contain counterfeit drugs.4 The person involved was arrested in the United States following deportation from the Bahamas, while on the way to Canada.
A second case occurred in 2006, in which Pfizer International discovered counterfeit products in the Euro Gulf Trading Co., located in the Jebel Ali Free Trade Zone (ICC, 2013). A complaint was filed, prompting an inspection by the General Inspection Department and the Investigations and Smuggling Control Section of the Dubai Seaports and Customs Authority. At the warehouss, inspectors found quantities of counterfeit goods, including pharmaceuticals, along with equipment used to print false production and expiration dates.
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← 1. See www.fda.gov/news-events/press-announcements/fda-and-cbp-bolster-collaboration-protect-public-health-and-safety.
← 3. Note by Turkey: The information in this document with reference to “Cyprus” relates to the southern part of the Island. There is no single authority representing both Turkish and Greek Cypriot people on the Island. Turkey recognises the Turkish Republic of Northern Cyprus (TRNC). Until a lasting and equitable solution is found within the context of the United Nations, Turkey shall preserve its position concerning the “Cyprus issue”.
Note by all the European Union Member States of the OECD and the European Union: The Republic of Cyprus is recognised by all members of the United Nations with the exception of Turkey. The information in this document relates to the area under the effective control of the Government of the Republic of Cyprus.