Counterfeit medicines online

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The online distribution of counterfeit medicines has been growing during the last decades. The role of Internet as an unregulated medicine market is the main reasons behind this phenomenon, especially the effectiveness of "spam" as a tool for advertising and promoting these products. Websites and social media are new powerful instruments that organized criminal groups could exploit to conduct their illicit businesses. The spread of this emerging threat worldwide poses a very high risk for the health and safety of unaware consumers.

Contents

Definition

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Two drug packages appear to be identical in normal light
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Selective UV wavelength identifies counterfeit package on left

On 29 May 2017, the World Health Assembly hosted by the World Health Organization agreed to have "Substandard and Falsified (SF) medical products" as the term to be used in all future documentation on the subject of substandard, spurious, falsified, falsely-labelled and counterfeit (SSFFC) medical products. [1] Under this definition, a counterfeit medicine is a falsified pharmaceutical product. The term "counterfeit" is avoided as this is connected to intellectual property rights rather than public health. [2] The meaning associated with "counterfeit medicines" incorporates various cases that are ascribable to the intentional replication of a product, or product parts, without permission.

Role of the Internet

The Internet has radically changed the approach towards commerce, drastically modifying also buyers' attitudes towards the purchase of goods in general. Research has demonstrated that using a computer to fill a prescription online and using online chat groups to learn about health topics are strong independent predictors of prescription drug importation from foreign countries by United States consumers. [3]

If on the one side the Internet created new opportunities for consumers, on the other it also represents a new powerful instrument that organized criminals could exploit to conduct their illicit businesses. With the Internet criminals have found an emerging marketplace that could possibly be exploited in many different ways to take advantage of the almost unlimited possibilities offered by cyberspace. [7] In recent years counterfeiters have been exploiting the Internet as an important channel to offer counterfeit medicines both at the wholesale and at the retail level, often creating an independent distribution process which directly targets distributors and final users.

At the wholesale, counterfeiter can exploit distributors' constant search for low costs products to maximize the profit. For what concerns the retail level, counterfeiters deceive consumers both with low prices and by sending a constant stream of spam messages to their e-mail inboxes. It is clear that the development of new communication technologies and the possibility of exploiting the massive Internet market, has unwillingly favored illegal activities.

E-pharmacies

Browsing through the Internet, it is easy to hit on online pharmacies that operate according to the regulations and with transparency. [8] For them, criminals are harsh unscrupulous competitors who advertise fake drugs and put at risk the reputation of all online pharmacies which operate honestly. However, the Internet nowadays plays a significant role in the worldwide diffusion of counterfeit pharmaceutical products. To support the business of legal online pharmacies, some institutions (for instance in the U.S.) developed an accreditation system for both online pharmacies connected with territorial ones and for those only operating through the Internet. Main limits concerning these systems are: the official seals of these institutions, to be posted on pharmacies website as a warrantee, can be roughly imitated; these institutions operate at the national level and, due to the different domestic laws of the countries, it is difficult for any of them to provide customers with reliable information concerning the quality of pharmaceuticals available online.

An overview of the various typologies of illicit e-pharmacies is now presented, basically focused on rogue and fake e-pharmacies. [9] Rogue e-pharmacies are those that not adhere to accepted standards of medicine and/or pharmacy practice, including standards of safety, thus violating regulations, and those that engage in fraudulent and deceptive business practices. They sell counterfeit pharmaceuticals through ad hoc designed websites which pretend authenticity and often contain features which aim to imitate legitimate ones. The impact of illicit e-pharmacies should not be underestimated: sewage epidemiology showed that >60% of the consumed sildenafil in the Netherlands was obtained from illegal sources. [10] The consumers still seem unable to grasp the risks associated with this particular issue. This happens also because the issue of online sales of counterfeit medicines does not seem to receive due attention by the media. On the other side, through fake e-pharmacies cyber criminals do not really sell medicines, but only use them as baits to defraud online buyers, as in the case of ID theft and credit card cloning. The scheme implies a spider-web composed of numerous websites aiming to attract victims. The goal is to infect the computers of the latter with a virus to steal valuable data.

Both types of deceptive e-pharmacies - rogue and fake ones - are often efficiently promoted by spam messages, which work even better during times of health crisis, when people go into frenzy over certain types of medicines and when there is a surge of cyber criminals seeking to cash in on the pandemic.

Deceiving strategies and tools used by criminals

The exploitation of the Internet by criminals caused the spread of uncontrolled and unverified pieces of information and products. Internet search engines, for instance, unwillingly contribute to keep illegal e-pharmacies in business. The struggle against rogue and fake online pharmacies requires combined efforts at different levels.

Besides the already mentioned "attractive factors". such as lower prices and anonymity, counterfeiters also use a variety of deceiving methods that are based on the fact that the potential buyers will never have the possibility to verify the authenticity of what is presented in the fake website. One of these elements is the logos of genuine online pharmacies, or the approval seal of controlling authorities. Moreover, to reassure potential consumers very often it is requested a medical prescription, as a requisite to purchase the online medicines. Thanks to these strategies, the phenomenon of counterfeit medicines sold online is more and more increasing. According to the EAASM [11] (European Alliance for Access to safe Medicines) 6 times out of 10, medicines bought online turned to be fakes.

International cooperation

With the launch of Operation Pangea [12] in 2008, for the first time illegal online pharmacies were targeted at the international level. In particular, the operation targeted three main components used by illegal websites: the ISP (Internet Service Provider), the payment systems and the delivery service. Along the years the operation gained notable momentum as the number of the participating countries rose from 10 to more than 80 in 2011. The four operations Pangea carried out between 2008 and 2011 led to always increasing number of arrests and seizures all around the world. In 2011 Pangea IV was the largest operation of its kind, involving 165 agencies and leading to the seizure of 2.4 million illicit and counterfeit pills originating from 43 countries; the shutting down of 13,500 websites and the inspection of 45,000 packages.

Due to the almost unlimited possibilities offered by cyberspace, purchasing pharmaceuticals over the Internet is easy while, on the contrary, tracing the various phases within the distribution chain can be difficult. It is for this reason that cooperation among different law enforcement agencies in different countries becomes essential.

Role of spam

Another interesting element to be analyzed is the role of spamming, to present how criminals are able to increase the possibility of success of their deceiving actions by reaching a greater number of potential victims and advertise their products. The term spam is used to describe the abuse of electronic messaging systems in order to indiscriminately send unsolicited bulk messages. The term unsolicited refers to the fact that the message is sent without a verifiable permission granted by the recipient. A message is considered bulk when it is sent as part of a larger collection of messages, all of which have an identical content. Spam is a problem of consent, rather than content. This is a significant element to take into consideration, as attempts to regulate contents of e-mail messages risk to contribute undermining the freedom of speech instead of efficiently fighting the phenomenon of spamming. 92% to 96% of e-mails received by most organizations are spam. [13] Spam volumes around the world reach about 250 billion messages a day, that is to say almost 40 spam e-mail messages a day for each woman, man and child in the world. [14] As it is a cheap and anonymous way to promote products on the Internet and since it also allows reaching a large number of people all over the world, spamming represents a very powerful advertising instrument. It is therefore one of the favorite ways used by organized crime to advertise their illegal activities and illicit products.

Online trade of counterfeit pharmaceuticals does not escape the rule and medicines are by all means among the most spammed online products. In particular, in some cases it is particular easy for spammers to take advantage of consumers' weaknesses. Some of the steps taken by organized criminals to make their operation effective are now presented.

In the past years several companies settled a series of actions against spammers. The various "joint actions" put in place are an important sign of the determination of the private sector to stop the misuse of the Internet for illegal purposes, nevertheless there are thousand of other smaller companies dealing with spamming on a daily basis that are unable to dispose of such amount of technological, financial and human resources to get engaged in such a fight.

Involvement of organized crime

The interest of organized crime towards the illicit trafficking of counterfeit medicines is clearly demonstrated by figures. [15] For instance, a pill of ecstasy costs between €0.20 and €0.30 and it is generally sold at €5. A Viagra pill costs around €0.15 and it is sold via an illicit website at around 8 to €10. A kilo of counterfeit Viagra pills (1,700 units) costs €255 and the retail value is from 13,600 to €17,000.

Organized crime is very much involved in the activity of many rogue and fake e-pharmacies all over the Internet, also through the spamming activity. Spamming is usually part of a wider criminal scheme: spam is a powerful advertising tool therefore organized criminals use it in order to expand their market. In this regard organized crime could rather be seen as a veritable illicit enterprise in which spammers hold the role of a sort of an advertising department.

Criminal operations over the Internet are clearly facilitated by the fact that it is indeed easy to register a domain name and to set up a website in a country, to create a back office in another one and to install an online shop in a third country, especially if one considers that many criminal groups operating at the transnational level already have established alliances and operate in several countries. Once the online shop is operational, it could as well easily direct payments to a fourth country and eventually invest the profits in a tax haven. Moreover, very often, in order to further confuse investigators, money is transferred between a chain of bank accounts, creating a smoke-screen which makes investigations more difficult.

See also

Related Research Articles

<span class="mw-page-title-main">Spamming</span> Unsolicited electronic messages, especially advertisements

Spamming is the use of messaging systems to send multiple unsolicited messages (spam) to large numbers of recipients for the purpose of commercial advertising, for the purpose of non-commercial proselytizing, for any prohibited purpose, or simply repeatedly sending the same message to the same user. While the most widely recognized form of spam is email spam, the term is applied to similar abuses in other media: instant messaging spam, Usenet newsgroup spam, Web search engine spam, spam in blogs, wiki spam, online classified ads spam, mobile phone messaging spam, Internet forum spam, junk fax transmissions, social spam, spam mobile apps, television advertising and file sharing spam. It is named after Spam, a luncheon meat, by way of a Monty Python sketch about a restaurant that has Spam in almost every dish in which Vikings annoyingly sing "Spam" repeatedly.

<span class="mw-page-title-main">Over-the-counter drug</span> Medication available without a prescription

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.

<span class="mw-page-title-main">Prescription drug</span> Medication legally requiring a medical prescription before it can be dispensed

A prescription drug is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.

<span class="mw-page-title-main">Internet fraud</span> Type of fraud or deception which makes use of the Internet to defraud victims

Internet fraud is a type of cybercrime fraud or deception which makes use of the Internet and could involve hiding of information or providing incorrect information for the purpose of tricking victims out of money, property, and inheritance. Internet fraud is not considered a single, distinctive crime but covers a range of illegal and illicit actions that are committed in cyberspace. It is, however, differentiated from theft since, in this case, the victim voluntarily and knowingly provides the information, money or property to the perpetrator. It is also distinguished by the way it involves temporally and spatially separated offenders.

<span class="mw-page-title-main">Regulation of therapeutic goods</span> Legal management of drugs and restricted substances

The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.

Canada Drugs otherwise known as CanadaDrugs.com, was an online pharmacy based in Winnipeg, Manitoba.

Racketeering is a type of organized crime in which the perpetrators set up a coercive, fraudulent, extortionary, or otherwise illegal coordinated scheme or operation to repeatedly or consistently collect a profit.

<span class="mw-page-title-main">National Agency for Food and Drug Administration and Control</span> Government agency in Nigeria

The National Agency for Food and Drug Administration and Control(NAFDAC) in Nigeria is a federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water.

The United States Food and Drug Administration (FDA) Office of Criminal Investigations (OCI) provides the FDA with a specific office to conduct and coordinate its criminal investigations.

An online pharmacy, internet pharmacy, or mail-order pharmacy is a pharmacy that operates over the Internet and sends orders to customers through mail, shipping companies, or online pharmacy web portal.

An out-of-pocket expense is the direct payment of money that may or may not be later reimbursed from a third-party source.

<span class="mw-page-title-main">Pharmacy (shop)</span> Shop which provides pharmaceutical drugs

A pharmacy is a retail shop which provides pharmaceutical drugs, among other products. At the pharmacy, a pharmacist oversees the fulfillment of medical prescriptions and is available to counsel patients about prescription and over-the-counter drugs or about health problems and wellness issues. A typical pharmacy would be in the commercial area of a community.

LegitScript is a Portland, Oregon-based internet and payments compliance company that provides services for merchant monitoring, platform monitoring, and certification in high-risk industries. The company also performs investigative analyses for government agencies around the world regarding cybercrime, and offers brand monitoring for intellectual property infringement. Some of LegitScript's partners include Google, Facebook, Amazon, Bing, and Visa. LegitScript also works with the U.S. Food and Drug Administration to monitor and investigate websites marketing FDA-regulated products.

A counterfeit medication or a counterfeit drug is a medication or pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body, may contain ingredients that are not on the label, or may be supplied with inaccurate or fake packaging and labeling. Counterfeit drugs are related to pharma fraud. Drug manufacturers and distributors are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimise the impact of counterfeit drugs. Antibiotics with insufficient quantities of an active ingredient add to the problem of antibiotic resistance.

Counterfeit consumer goods are goods, often of inferior quality, made or sold under another's brand name without the brand owner's authorization. Sellers of such goods may infringe on either the trademark, patent or copyright of the brand owner by passing off its goods as made by the brand owner. Counterfeit products made up 5 to 7% of world trade in 2013, and in 2014 cost an estimated 2.5 million jobs worldwide, with up to 750,000 jobs lost in the U.S. About 5% of goods imported into the European Union in 2013 were fakes, according to the OECD.

<span class="mw-page-title-main">Drug packaging</span> Packaging for pharmaceutical preparations

Pharmaceutical packaging is the packages and the packaging processes for pharmaceutical preparations. It involves all of the operations from production through drug distribution channels to the end consumer.

Established in 2002, the Canadian International Pharmacy Association ("CIPA") is a Canadian association of licensed pharmacy businesses offering mail order pharmacy services to Canadian and international patients. CIPA members sell pharmaceuticals and maintenance medications to individuals upon receipt of a valid prescription. In addition to selling Health Canada approved medications from their licensed Canadian pharmacies, CIPA members also have relationships with regulated international pharmacies and inspected fulfillment centres that directly deliver medications to patients. Patients make the choice from where their medications will be delivered, and this is confirmed with them at time of purchase.

Online doctor is a term that emerged during the 2000s, used by both the media and academics, to describe a generation of physicians and health practitioners who deliver healthcare, including drug prescription, over the internet.

<span class="mw-page-title-main">Illicit cigarette trade</span>

The illicit cigarette trade is defined as “the production, import, export, purchase, sale, or possession of tobacco goods which fail to comply with legislation”. Illicit cigarette trade activities fall under 3 categories:

  1. Contraband: cigarettes smuggled from abroad without domestic duty paid;
  2. Counterfeit: cigarettes manufactured without authorization of the rightful owners, with intent to deceive consumers and to avoid paying duty;
  3. Illicit whites: brands manufactured legitimately in one country, but smuggled and sold in another without duties being paid.

The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution.

References

  1. ↑ For more information see also WHO website: http://www.who.int/medicines/regulation/ssffc/en/
  2. ↑ Venhuis BJ, Oostlander AE, Giorgio DD, Mosimann R, du Plessis I (2018). "Oncology drugs in the crosshairs of pharmaceutical crime". The Lancet Oncology. 19 (4): e209–e217. doi:10.1016/S1470-2045(18)30101-3. PMID   29611529.
  3. ↑ Zullo, Andrew R.; Dore, David D.; Galárraga, Omar (March 2015). "Development and validation of an index to predict personal prescription drug importation by adults in the United States". Journal of Pharmaceutical Health Services Research. 6 (1): 33–41. doi:10.1111/jphs.12088. PMC   4930104 . PMID   27375777.
  4. ↑ Zullo, AR; Howe, CJ; Galárraga, O (2 February 2016). "Estimating the Effect of Health Insurance on Personal Prescription Drug Importation". Medical Care Research and Review. 74 (2): 178–207. doi:10.1177/1077558716629039. PMC   4970983 . PMID   26837427.
  5. ↑ Zullo, AR; Howe, CJ; Galárraga, O (2 February 2016). "Estimating the Effect of Health Insurance on Personal Prescription Drug Importation". Medical Care Research and Review. 74 (2): 178–207. doi:10.1177/1077558716629039. PMC   4970983 . PMID   26837427.
  6. ↑ Zullo, AR; Howe, CJ; Galárraga, O (2 February 2016). "Estimating the Effect of Health Insurance on Personal Prescription Drug Importation". Medical Care Research and Review. 74 (2): 178–207. doi:10.1177/1077558716629039. PMC   4970983 . PMID   26837427.
  7. ↑ For more in-depth information on the role of Internet in counterfeiting see UNICRI (2007), Counterfeiting: a global spread a global threat, chapter 5, p.89, available online at: http://counterfeiting.unicri.it/report2008.php Archived 2012-06-24 at the Wayback Machine
  8. ↑ Zullo, AR; Howe, CJ; Galárraga, O (2 February 2016). "Estimating the Effect of Health Insurance on Personal Prescription Drug Importation". Medical Care Research and Review. 74 (2): 178–207. doi:10.1177/1077558716629039. PMC   4970983 . PMID   26837427.
  9. ↑ See also AIFA-EDQM (2011), "Counterfeit Medical Products and Similar Crimes. Risk Communication"
  10. ↑ Venhuis BJ, de Voogt, P, Emke, E, Causanilles, A, Keizers, PHJ (2014). "Success of rogue online pharmacies: sewage study of sildenafil in the Netherlands". BMJ. 349: g4317. doi:10.1136/bmj.g4317. PMID   24989165. S2CID   38052344.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  11. ↑ EAASM (2011), When is a medicine not a medicine?, online at http://www.eaasm.eu/
  12. ↑ INTERPOL, http://www.interpol.int/Crime-areas/Pharmaceutical-crime/Operations/Operation-Pangea Archived 2016-06-13 at the Wayback Machine
  13. ↑ FIRSTBROOK P. (2007), "Benchmarking Anti-spam Effectiveness", Gartner, September 18th, Securing the Network from Spam, Malware and other Threats. A Strategic Overview Featuring Gartner Content, 3rd issue, Clearswift, available online: http://www.clearswift.com/__data/assets/pdf_file/0020/3674/Clearswift_issue3.pdf%5B%5D
  14. ↑ "Spam, a lot", The New York Times, published 13 January 2011. Article available here: https://www.nytimes.com/2011/01/14/opinion/14fri4.html
  15. ↑ For more information on organized crime involvement in counterfeiting activities see also UNICRI (2007), Counterfeiting: a global spread a global threat, chapter 6, p. 103
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