The lucrative and popularity of selling medicine online
The rapid growth of technology has transformed many brick-and-mortar businesses into
online businesses, and medicines are now being sold over the internet. Influenced
by the notions that online purchases are economical and do not require a prescription,
the general public are keen to purchase medicine online through websites, social media
and mobile apps. Online medicine purchase is presumed to be convenient and confidential,
free from embarrassment of sharing personal and sensitive health information to a
healthcare professional. Public in United States, Europe, Australia is generally aware
that internet sales form part of the official medicines distribution channels, often
a valid prescription is required for controlled medicine. However, unlicensed, substandard
and falsified medicines with various dubious medical claims are advertised and sold
illegally in many rogue online pharmacies (Jack, 2016). These include medications
for weight loss, hair growth, and treatment of erectile dysfunction. Such medicines
are termed as substandard, spurious, falsely labeled, falsified and counterfeit medical
products by the World Health Organisation (WHO). Similarly, the European Commission
defines such products as falsified medicines or fake medicines that pass themselves
off as real, authorized medicines (European Commission, 2016). These medicines may
contain substandard active ingredients, which are low quality and/or an incorrect
amount, either too high or too low, and have not been properly evaluated by authorities
in terms of quality, safety, and efficacy. It must be noted that falsified medicines
are often confused with counterfeit medicines. According to European Commission, counterfeit
medicines refers to medicines that do not comply with European Union law on intellectual
and industrial property rights, for example, unregistered medicines sourced from parallel
import (European Medicines Agency
1
). In this article, the illegal sales of both counterfeit and falsified medicines
(CFMs) are discussed.
In 2012, the WHO estimated the CFMs industry to be worth USD 431 billion a year, but
further estimates has not been reported in the recent years due to the fast growing,
widespread practice of this industry, making it impractical to estimate on a global
scale (Garrett, 2012). Authorities are finding it difficult to curb CFMs due to the
lack of governance over the internet. Furthermore, fragmented cybercrime legislation
leads to large substantive and procedural lacunae in law, rendering law enforcement
efforts useless.
Plaguing the lacunae: case studies of India, China and African Countries
The crackdown on CFMs sale by authorities can only be effective with the present of
relevant legislation to empower the judiciary to impose substantial sentences. Countries
such as China, India and African countries previously had either no specific or weak
law governing the control of CFMs. To address this problem, new legislations have
been drafted and combined with the existing legislation. Strengthening of drug legislation
is vital as CFMs are found alongside genuine medicines in legitimate distribution
channels, making it impossible for consumers to determine the authenticity of the
medicines (Office of the United States Trade Representative, 2016). In 2013, the China
Food and Drug Administration led an inter-agency operation named “Two Strikes, Two
Setups” targeting illegal manufacture and sale of medicines, which successfully closed
down 194 Chinese websites and reported 609 overseas websites to their relevant countries
for further enforcement actions (Alliance for Safe Online Pharmacies, 2015). China,
believed to be the biggest producers of CFMs, is showing encouraging signs in this
issue with the amendment of Article 141 of the Criminal Law in 2011. The amended penalties
for manufacturing and selling CFMs are punishable to a minimum imprisonment of 10
years, in addition to a fine or forfeiture of property (Congressional-Executive Commission
on China, 2011). For India, harsh sentences imposed in 2008 through the Drug and Cosmetic
Act 1940 amendments, result in a minimum 10 years and/or a minimum fine of Indian
Rupees (INR) 1 million (USD 15,000) or three times the value of the medicines confiscated.
However, the anti-counterfeiting and anti-falsifying provision does not extend to
the regulating of online pharmacies, due to the lack of clarity in the Drugs and Cosmetics
Act 1940 and the Drugs and Cosmetics Rules 1945 (Nagaraj et al., 2014). In December
2015, the office of the Drugs Controller General (India) issued a directive banning
the sale of medicines over the internet and taking action against online pharmacies
such as Zigy.com, Netmeds.com and mCHEMIST.com (Reddy, 2015). However, in the absence
of clear legislations and policies on online pharmacies, the directive is under scrutiny
due to the differences in the interpretation of law, impeding the authorities' efforts
to curb CFMs sold in illegal online pharmacies.
In Africa, the East African countries such as Uganda and Kenya are strengthening and
enforcing laws against CFMs. Uganda's new Anti-Counterfeiting Goods Bill, passed in
October 2015 aims to introduce punitive, deterrent and effective measures for combating
the production or marketing of counterfeit goods. Prior to 2015, there were no law
that prohibits or controls the manufacturing and marketing of counterfeit and falsified
goods. Although the National Drug Policy and Authority Act 1993 provides some guidance
on the sale and supply of substandard medicine, the non-specificity of this act on
CFMs is seen as the failure of Uganda war against the offense. In addition, a minimum
jail term (7 years) was introduced in the new bill, a penalty absents from the National
Drug Policy and Authority Act (Parliament Watch, 2015). In Kenya, efforts against
CFMs have been strengthened significantly over the past few years, with the establishment
of the Anti-Counterfeit Act in 2008 and the passing of several amendments. The latest
amendment in 2014 paved the way for the establishment of an Intellectual Property
Enforcement and Co-ordination Advisory Committee and the power to compound offenses,
reducing the hassle and resources of prosecution and conviction through the judiciary.
Nevertheless, the efforts of these countries in strengthening pertinent legislation
are inadequate with the growing widespread availability of CFMs over the internet.
This global public health threat extends beyond national borders and many countries
currently do not have specific laws that deal with the selling of CFMs over the internet
(Govtrack.us, 2008).
Weaning impact of international collaborative operations
Because of extensive intermediaries' and suppliers' networks across the globe, the
sale of CFMs through illegal online pharmacies is difficult for law-enforcement agencies
to control. Such organized crimes mostly operate using rogue domain name registrars,
electronic payment systems and international and local delivery services. Standalone
enforcement efforts by individual countries have failed to cripple the networks, only
temporarily ceasing operations in these countries before they became fully re-operational
after a few days. Seeing the need for an integrated enforcement operation, INTERPOL
along with other agencies launched Operation Pangea, a global cooperative operation
targeting the online sale of CFMs. During the operations, the makers and distributors
of CFMs are identified and these medicines are removed from the supply chain (INTERPOL,
2016).
In 2016, Operation Pangea IX targets 3 main aspects of illicit medicine trafficking
through the Internet Service Providers (ISPs), payment systems and electronic delivery
services. The operation also targets some main aspects that are exploited by organized
crime in trafficking medicines online: fraudulent domain name registrars, electronic
payment systems and medicine delivery. The success in these operations (Table 1) is
also because of the involvement of private internet-related agencies and agencies
that handle online payments. These agencies such as MasterCard, PayPal and VISA are
crucial to curtailing financial support (INTERPOL, 2016). However, Operation Pangea
is slowly showing signs of over-inflated impact as it is an intrinsic limitation to
check enormous quality of shipments from all custom checkpoints regularly and effectively.
Table 1
Results of operation pangea I till IX (2008 till 2016) (INTERPOL, 2016).
OP/Year
Countries participated
Agencies involved
Websites suspended
Suspects arrested/ under investigation
Number of pills seized (millions)
Value of seized product (USD millions)
Postal packages seized
OP IX/2016
103
193
4,932
393
12.2
53
170,340
OP VIII/2015
115
236
2,410
156
20.7
81
NA
OP VII/2014
113
198
11,800
434
9.6
32
NA
OP VI/2013
99
NA
13,700
213
10.1
36
41,000
OP V/2012
100
NA
18,000
80
3.75
10.5
6,700
OP IV/2011
81
NA
13,500
55
2.4
6.3
8,000
OP III/2010
44
NA
297
87
2
6.77
NA
OP II/2009
25
NA
153
59
NA
NA
NA
OP I/2008
10
NA
NA
NA
NA
NA
NA
Mean
77
209
8,099
185
9
32
56,510
Median
99
198
8,366
122
10
32
24,500
OP, Operation Pangea; NA, Not available.
Way forward: raising international collaboration and consumer awareness
Due to the sheer size of organized crime networks, stand-alone operations in individual
countries might not be adequate to stop the overall trend. Concerted inter-country
and inter-regional operations may well be the answer to this conundrum. The Alliance
for Safe Online Pharmacies EU (ASOP EU), formed in 2011, is a coalition dedicated
to protecting patient safety online. Currently ASOP EU has 31 members including Google,
Pfizer and EAASM, as well as 26 observers including eBay, PayPal, Visa and Microsoft
(Alliance for Safe Online Pharmacies EU, 2016). Regional partnerships such as ASOP
EU and EAASM are important to exert influence on the political and legislative bodies
to ensure new regulation and regular enforcement of online surveillance. Similarly,
these alliances could strengthen collaboration among law-enforcement agencies on cybercrime
involving pharmaceuticals and strengthen the human resource and capacity to tackle
cybercrime.
As a follow-up to the successful piece of research “The Counterfeiting Superhighway,”
EAASM launched an innovative “Counterfeiting the Counterfeiter” campaign in Germany
in 2011 to increase public awareness about CFMs sold online and direct patients to
safe and legitimate sources of medicines at the same time. In this project, several
websites were designed to attract unsuspecting regular users to login to order their
medications without having a prescription. Immediately, when the users clicked the
purchase button, they were directed to an authorized online pharmacy website which
gave an educational message about the risk of illegal websites. An average of 2,800
people browsed the disguised websites each day and the projected sales volume (based
on items intended for purchase) was USD 13.2–38.6 million per year. This study confirmed
the hypothesis of the EAASM that illegal online pharmacies have low start-up costs
and exorbitant returns (European Alliance for Access to Safe Medicines, 2012).
The Falsified Medicines Directive was introduced by the European Commission in 2013.
It entails a certification mark or common logo that is compulsory for websites selling
medicinal products to display. The certification mark will enable patients to differentiate
authorized online medicine retailers. These authorized online retailers must provide
a link on their webpage to the national pharmaceutical regulator's website to ensure
potential customers can double-check the authenticity of the legal status of the operator.
Emphasis must be given to raise consumer awareness about the risks and dangers of
buying medicines online. The Medicines and Healthcare products Regulatory Agency (MHRA)
confirmed that 79% of the UK public who took part in a survey on online medicine purchases
were unaware of CFMs (Medicines Healthcare Products Regulatory Agency, 2016). As a
result, the MHRA is creating public awareness about CFMs sold online via a campaign
webpage with practical tips on recognizing legitimate online retailers of medicines
and medical devices (Medicines Healthcare Products Regulatory Agency, 2016). The Food
and Drug Administration (FDA) in the US has embarked on a similar campaign “BeSafeRx:
Know Your Online Pharmacy” to disseminate information about how to identify an illegal
pharmacy website and cues to detect illegal websites (U.S. Food Drug Administration,
2016). It must be noted that the public is advised to log on to the regulatory authorities'
portals to check for the details of the medicine approvals as well as licensing. A
country-by-country list of the websites to check the medicine registration information
is available at http://crash2.lshtm.ac.uk/Regulatory.htm. Online medicine retailers
should always adhere to the provisions of existing laws because selling medicines
in cyberspace does not mean they are outside of the law. The public is also advised
to be vigilant when buying medicines online and should always make checks before clicking
to purchase.
Conclusion
To date, health authorities' efforts in combating CFMs by strengthening the anti-counterfeit
and anti-falsifying legislations should be lauded. However, immediate action needs
to be taken to fill in the legislative lacunae of the online sale of CFMs. In addition,
the international collaboration against the online sale of CFMs should be continued
by encouraging more countries to participate. Nevertheless, the fight against CFMs
should not be limited to legislation, enforcement and global collaboration of government
authorities per se. Instead, multipronged strategies, including adoption of anti-falsifiying
technology and raising the awareness among all stakeholders, principally the general
public may be the turning point in winning the battle against this unscrupulous business.
Author contributions
Conceived and designed the experiments: RP, SZ, LM. Wrote the paper: KL, SY, RP, SZ,
LM. Designed search strategies: KL, SY, RP, SZ, QY, YA, LM. Critically reviewed the
manuscript for important intellectual content: KL, SY, RP, SZ, LM. All authors read
and approved the final version.
Conflict of interest statement
The authors declare that the research was conducted in the absence of any commercial
or financial relationships that could be construed as a potential conflict of interest.