A wide array of public health and law enforcement stakeholders, including WHO, the UN Office of Drugs and Crime (“UNODC”), the International Criminal Police Organization (“Interpol”), the FDA, NAPB, the USA Federal Bureau of Investigation, the International Pharmaceutical Federation, the European Federation of Pharmaceutical Industries and Associations, the Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association, the Pharmaceutical Security Institute and numerous other public and private sector groups have specifically recognized the global challenges posed by the Internet and illicit online pharmacies [19, 22, 42–44]. Yet few solutions have emerged to confront this form of globalized pharmaceutical cybercrime.
Further, strategic approaches are complicated given the unclear applicability of domestic laws and general lack of enforcement in the Internet service sector. For example, although this criminal activity is perpetrated by a host of clearly criminal actors (e.g., illegal manufacturers, organized crime, illicit online pharmacies), others, including Internet Service Providers (e.g., search engines, social media platforms, hosting companies, payment processors, affiliate sites, transportation companies, etc.), enable illicit online pharmacy operations but often span multiple jurisdictions and legal regimes (including those that may be exempt from liability) [19–21, 44] (See Figure 1). This patchwork of various illicit and legal actors makes it difficult to detect, prevent and engage in enforcement efforts against illicit online pharmacies at the domestic level, consequently requiring global coordination and cooperation that is elusive without effective multistakeholder governance [20, 22].
Below we identify some of the current global governance efforts attempting to address illicit online pharmacy regulation at the national government level, voluntary governance mechanisms addressing the promotion of pharmaceuticals, and global law enforcement efforts taken against illicit online pharmacies.
Sovereign regulatory efforts
Legislative responses from national governments to address the proliferation of illegal online pharmacies and their eDTCA have been largely absent. Though sovereign drug regulatory authorities usually regulate prescription drugs and medical products sold by traditional brick-and-mortar pharmacies, most have failed to regulate online pharmacies as a distinct category [15, 19]. For example, a recent Member State survey by the WHO Global Observatory for e-Health (“GOe”) found 66% of respondents had no legislation either explicitly allowing or prohibiting Internet pharmacy operations [15]. Of those countries regulating online pharmacies, only 19% prohibited this practice, and indeed, 7% allowed it without adequate law enforcement considerations [15].
Importantly, developing countries, with fewer resources, were more likely to be silent on regulation of this public health risk [15]. Indeed, the vast majority of respondents (86%) did not regulate, accredit, or certify Internet pharmacy sites, and 75% had no regulations permitting or prohibiting the online purchasing of pharmaceuticals from other countries, a practice which has already been identified as creating significant and demonstrable health risks [15]. Even among the few countries that prohibit online medicine foreign sourcing, only 20% of this group had specific law enforcement consequences [15].
Even if a country has enacted specific legislation, such efforts may be inadequate and outdated to effectively deal with the rapidly changing pace of the Internet environment. As an example, the USA, which has a strong drug regulatory regime and extensive technological access, enacted the Ryan Haight Online Pharmacy Consumer Protections Act in 2008, regulating the online sale of controlled substances [19, 44]. Yet on closer inspection, this law has significant limitations.
For example, the Act is limited in scope to only USA Drug Enforcement Administration scheduled controlled substances, which does not adequately cover the host of medication therapeutic classes currently sold illicitly over the Internet [45]. It also limits its oversight to illicit sellers located in the USA, despite the observation that the bulk of these illicit marketers and sellers are outside the country [45]. Further, there appear to be no successful prosecutions under the Act and reports by Internet monitoring companies indicate that illicit online pharmacies marketing the “no prescription” sale of controlled substances continue to operate despite passage of the law [46].
Voluntary governance mechanisms
There have also been voluntary guidelines issued to address DTCA and other form of medicines promotion. For example, the WHO Ethical Criteria for Medicinal Drug Promotion (“WHO Criteria”) provides basic aspirational tenets [47]. While these criteria were focused on legitimate actors, principles contained therein are relevant to current illicit online pharmacy promotional activities. These guidelines indicate that DTCA medicines promotion should: (a) be reliable, accurate and truthful; and (b) not contain misleading statements or omissions that would give rise to risk [47].
Despite their seeming uncontroversial, foundational nature, decades after introduction of the WHO Criteria, WHO surveys have found a large fraction (~1/3rd) of countries have little to no regulatory oversight over pharmaceutical promotion [48, 49]. Further, even more concerning, even fewer countries have adequate capacity or resources to regulate either licit or illicit pharmaceutical promotion [48, 49], exposing their populations to public health and individual patient safety harms associated with DTCA and eDTCA.
Crucially, the WHO Criteria also fail to specifically address emerging challenges of the Internet as a medium for promotion and influencing health behavior. Further, its voluntary nature highlights certain global governance limitations in regulating marketing by illicit online pharmacies as guidelines only hold potential influence over good faith actors, not criminal actors who dominate this space. In this regard, other efforts, such as the NGO HealthOntheNetFoundation Code of Conduct recommending websites voluntarily adhere to certain principles and undergo certification to ensure quality of online health information, may also be limited in effectiveness and lack applicability to online pharmacies [15].
Other voluntary efforts are marginally better because they identify specific, legitimate online pharmacies that have undergone credentialing and necessary domestic inspection requirements. For example, credentialing agencies partnering with national drug regulators, such as NABP and the Royal Pharmaceutical Society of Great Britain, have created their own programs as well as maintain lists of websites that they have identified as highly suspect [15, 19, 37]. The European Parliament has also attempted to specifically address illegal Internet medicine sales through issuing Directives aimed at developing enforcement measures and differentiating illicit actors from legitimate sources by using credentialing and a common logo [50]. However, participation in these programs has been limited, and consumers have limited knowledge of the value of these programs in engaging in online sourcing behavior.
Global law enforcement efforts
Although national online pharmacy legislation and voluntary governance initiatives attempting to regulate global pharmaceutical promotion have been limited in effectiveness, criminal law enforcement efforts have shown promise. These largely field-based operations have targeted the shut down of illicit online pharmacies and are coordinated by international organizations such as Interpol and the UNODC.
In fact, recently, Interpol, the world’s largest international police organization, announced a comprehensive multimillion-dollar global initiative to fight pharmaceutical crime in cooperation with 29 of the world’s largest pharmaceutical companies [51]. This investment in online pharmacy cybercrime prevention includes the recent “Operation Pangea VI”, a multi-stakeholder initiative involving law enforcement, the pharmaceutical and wholesaler industries, the Internet service sector, credit card companies, health regulators and customs agencies cooperating to target enforcement against illicit online drug sellers [52]. Operation Pangea VI resulted in a reported 9.8 million potentially dangerous medicines confiscated (at an estimated worth of USD$41 million), shut down of greater than 9,000 websites, and arrested or placed under investigation 58 individuals around the world [52]. This represents a marked increase in online enforcement activity since Operation Pangea II in 2009, which reported shut down of 153 websites and 12 arrests/individuals under investigation [53].
UNODC has also taken an active role in the global fight against transnational organized crime involved in the trafficking of counterfeit medicines [54]. This includes partnership with the International Narcotics Control Board, which has specifically called upon governments to engage in enforcement against illicit online pharmacies [55]. This partnership also included an emphasis on enforcement and prevention of online pharmacy use of social media marketing to target youth and children, one of the few times there has been international recognition of the emerging threat of illicit eDTCA use in Medicine 2.0 technologies [55].
Despite Interpol and UNODC-led efforts, lack of a sustained and internationally agreed upon multilateral/multistakeholder mechanisms for proactive identification, prevention, and enforcement against illicit online pharmacies persists. Global coordination is limited, allowing these virtual criminal actors to remain active worldwide and continually create new illicit eDTCA and cyberpharmacies. Though limited in effectiveness, Operation Pangea represents a potentially successful model of partnership and collaboration among the wide range of stakeholders necessary to address this problem and can be built upon strategically for future efforts. Indeed, without multi-lateral/sector cooperation, it is simply impossible to target and disable all relevant technologies supporting illicit online pharmacies [20].
Other public private partnership models (“PPPs”) have also been tried as potential governance mechanisms beyond Interpol’s Operation Pangea. For example, the Alliance for Safe Online Pharmacies and Center for Safe Internet Pharmacies are attempting to coordinate efforts addressing marketing and sales by illicit online pharmacies in the USA [44, 56, 57]. In addition, countries such as China have also engaged in public-private collaboration, recently forming a partnership between Chinese search engine Baidu and the State Food and Drug Administration to provide online certification and search results identifying legitimate online pharmacies [58]. The effectiveness of these programs remains to be seen; however, without investment and tangible mechanisms to enable action and coordination across geopolitical lines, their effectiveness to address the complexity of the online pharmacy problem is questionable.