INTRODUCTION

Addressing the scourge of counterfeit drugs is tremendously challenging. The global nature of illicit sellers and willing participants in this crime has extended beyond geopolitical borders. Hence, it is imperative that a public and private, international cross-stakeholder efforts be integrated to best coordinate efforts to identify, investigate and prosecute these crimes. The Pharmaceutical Security Institute (PSI) is one entity that represents a facilitator and collaborator in combatting this key public health issue.

Established in the early 1990s and now supported by the security directors from 26 international, research-based pharmaceutical manufacturers, the mission of PSI is to assist member pharmaceutical manufacturers to collect and analyze information related to the counterfeiting, illegal diversion and theft of pharmaceuticals and to disseminate that information to law enforcement and drug regulatory authorities. The objective of these efforts is to disrupt well-established counterfeiting groups. The security directors and their staff regularly work with law enforcement authorities to stem the flow of illegal, unapproved and dangerous medicines. Below, some of the activities that illustrate these public–private partnership efforts are reviewed.

COUNTRY, REGION AND GLOBAL SUCCESSES

Although it is impossible to fully detail all of the successful anti-counterfeiting efforts, a review of recent police, drug regulators and customs officials can provide insights into the effectiveness and need for public–private partnerships in this arena. These partners have achieved significant results on a country, regional and global basis.

The sheer amounts of counterfeit materials found using these partnerships are impressive. For example, the authorities in Mexico arranged for the public destruction of over 60 tons of unsafe medicines on 10 November 2010; an event in which PSI participated. Importantly, these drugs were identified and removed from the public health system there. Many of these drugs were counterfeit, expired or stolen and earmarked for patient use.

Beyond destruction of contraband counterfeit and substandard drugs, getting to the heart of the criminal element is also an important facet of public–private partnerships. Acting in part on private industry information, large organized criminal groups and sellers have been targeted. For example, working to establish an effective enforcement presence at the notorious ‘El Santuario’ in Guadalajara, three major raids were conducted in 2010.1 In April, over 10 tons of illegal medical products were seized. Following this effort, in July 2010, a total of 21 clandestine pharmacies were raided by the office of the Judge Advocate General of Justice for the State of Jalisco, the Federal Attorney General, the Federal Agency of Investigations, the Federal Commission for the Prevention of Health Risks. These raids resulted in the seizure of another 6 tons of unsafe medicines.

Other nuanced activities are also instructive. Beyond counterfeits destruction and criminal organization targets, transport pathways of supporting players in the counterfeit drug crimes regionally can also be an area to allow intelligence from private entities to coordinate with public efforts. For example, Cambodia has been identified by private sources as a critical transit region of counterfeit medicines shipped by criminal groups operating in China. During 2010, public authorities engaged in a campaign from March to August to identify and seize dangerous drugs. These illicit drugs, totaling some 19 tons, were subsequently destroyed in early August. Coordinated with this effort, the inter-Ministerial Committee to Fight against Counterfeit and Substandard Medicines closed down nearly 65 per cent of all illegal pharmacies last year in Cambodia.2

Globally, INTERPOL and the Permanent Forum against International Pharmaceutical Crime lead a enforcement action against illegal online pharmacies during October 2010.3 Notably, this was the third consecutive year enforcement actions have been undertaken on an international basis against well-organized trans-national criminal gangs. In all, 45 countries participated in this operation, using information supplied by private information supplied by PSI member companies.

This international effort, known as Pangea III, was conducted within the framework of the WHO International Medical Products Anti-Counterfeiting Taskforce (IMPACT). Initial reports disclosed the seizure of counterfeit pills with an estimated value of USD 2.6 million, as more than 1 million illicit and counterfeit pills were confiscated – including antibiotics, steroids, anti-cancer, anti-depression and anti-epileptic pills, as well as weight reduction medications. Increases in web site shutdowns (290 v. 153), inspected packages (268 000 v. 21 000), seized packages (11 000 v. 2356) and arrests (76 v. 59) from the previous collaborative effort shows the growing scope of enforcement and criminal activities.

EPIDEMIOLOGY OF COUNTERFEITS: A NEW HIGH IN 2010

Despite recent successes in combatting counterfeit drugs, challenges remain. It is important that counterfeit drugs are recognized as a global concern, because in many countries drug regulation is ineffective and leads to clandestine manufacturing. From these clandestine laboratories or illegal pharmaceutical manufacturing facilities, unsafe medicines move around the world. In 2010, nearly one-half of all incidents recorded by PSI involved commercial size seizures.

Further, during 2010, the incidence of discovery of counterfeit medicines reached a new high. The PSI Counterfeit Incident System (CIS) recorded 2054 new incidents of counterfeiting, illegal diversion and major theft of pharmaceuticals impacting 112 different countries. That was six fewer countries than in 2009, but 14 of these countries had not experienced an incident in 2009. So while the total number of countries has fallen, these crimes have increased to record levels while also being spread to new countries. Overall, there were 1735 incidents of counterfeiting, 278 of diversion and 41 major theft incidents. The top five countries in terms of counterfeiting incidents for 2010 included: China, the United Kingdom, India, South Korea and the United States.

Note that counterfeited drugs are not limited to simply lifestyle drugs. All drug forms and life-saving drugs have also been counterfeited. Concerning specific pharmaceuticals, 593 individual products were identified as having been discovered during these incidents. Oral dosage forms accounted for 88 per cent of the products and injectable forms for 7 per cent. CIS data revealed that medicines in the genitourinary, anti-infective and central nervous system therapeutic categories accounted for the largest number of incidents. These three categories were seen as having drugs that were the most frequently targeted by entities engaged in pharmaceutical crimes, starkly illustrating the fact counterfeiters do not limit themselves to lifestyle drugs. The three therapeutic categories, pharmaceutical categories, which experienced the largest increase on a year-to-year basis were metabolism, cytostatics and cardiovascular. In 586 of the incidents, the entire packaging and the products contained therein were reported as counterfeit.

CONTINUING PATIENT HARMS

The human side of the counterfeit drugs issue is perhaps the most important to consider when considering the need to fight the counterfeit drug problem. However, just as it is impossible to fully detail all of the successful anti-counterfeiting efforts, it is equally difficult to identify the many people who have suffered grave consequences from their unknowing use of counterfeit medicines. However, some publicly available information can illustrate the suffering from these illicit activities.

For example, 23 October 2010 issue of the Shanghai Daily included a report that the Chinese State Food and Drug Administration (SDFA) and the Shanghai Public Security Bureau were investigating a Beijing pharmaceutical plant for allegedly producing a counterfeit version of the drug Avastin. The fake Avastin caused eye infections in 61 patients at the Shanghai No. 1 People's Hospital.

In November 2010, published reports disclosed the discovery of counterfeit versions of 13 key anti-malarial medicines that had been uncovered across Ghana by the Medicines Quality Monitoring Surveillance program further underscoring the potential risk to seriously ill patients.4

Importantly, the recent Ukraine experience shows additional evidence as to the ability of counterfeiters to enter the legitimate supply chain. The Ukrainian Ministry of Healthcare recently stated that the amount of counterfeits in pharmacy chains tripled during the first-half of 2010. Medicines found to be illicit were those that were labeled under India, Belgium, French, German, Lithuanian and Ukrainian brands.5

This growing awareness of the adverse public health impact on patients worldwide was recently recognized in formal United Nations reporting. In July 2010, the United Nations Office on Drugs and Crime reported that the outsourcing of drug production to Asia has ‘fostered the growth of counterfeiting’6 and the flow of counterfeit goods has increased dramatically. Furthermore, the office found that trafficking of medicines is an opportunistic crime, which is extremely callous as it deprives the poorest of life-saving medicines.7 Hence, the public health impact of illicit counterfeit activity is not only a deadly crime, it preys on some of the most vulnerable patients in the world.

GLOBAL CRIMES REQUIRE GLOBAL RESPONSES

Since 1988, the World Health Organization (WHO) has attempted to address the counterfeit medicine problem. Issuing resolutions in 1988, 1994 and 1999, WHO took a major step forward in 2006 when it established the IMPACT. This collaboration among multiple stakeholders included regulators, enforcement officials, public health professionals and experts from the private sector. It moved forward with working groups focused on legislative, regulatory, communications, technology and enforcement issues.

Unfortunately IMPACT's work ground to a halt as disagreements arose over minor issues. By May 2010, the World Health Assembly deemed it necessary to create an Intergovernmental Working Group to review WHO's measures to assure safety, quality and efficacy of medicines; review the role of the IMPACT initiative; and lastly, to produce recommendations. These analyses have yet to be performed.

Fortunately as the IMPACT initiative has stalled, other global organizations have become more actively engaged. For example, the World Customs Organization initiated its ‘Counterfeiting and Piracy’ program. The World Intellectual Property Organization has continued to co-organize a Global Congress on Piracy and Counterfeiting. And, as outlined above, INTERPOL has been singularly effective as a leader of the global anti-counterfeiting of medicines enforcement initiatives. At the 79th Session of their General Assembly, 141 countries adopted a resolution to improve international cooperation and support to the INTERPOL General Secretariat in combating counterfeit medical products and pharmaceutical crime. The resolution specifically calls for these crimes to be viewed as a law enforcement priority in order to disrupt the criminal networks involved.8

ROLE OF THE PRIVATE SECTOR IN PUBLIC–PRIVATE PARTNERSHIPS

Many private sector organizations have been working to support public authorities. International trade organizations, NGOs such as PSI, as well as individual manufacturers contribute their expertise to facilitate the work of the public sector agencies.

In addition, for example, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has been involved in this work for nearly three decades. It has provided significant technical support to WHO while facilitating communication from its Geneva Headquarters and at international events and training sponsored by industry.

To further these efforts, in May 2010, IFPMA identified 10 principles on counterfeit medicines.9 Importantly, the first principle identified is that counterfeiting of medicines is a crime against patients since counterfeiters deliberately and deceitfully pass off their products as something they are not – genuine approved medicines. As such, counterfeit medicines are not an intellectual property or patent issue, but instead are a global public health threat that leads to resistance to treatment, illness, disability and even death. And just as importantly, IFPMA recognized that global public–private cooperation was needed as counterfeiting operations do not recognize borders and called for leadership by the WHO and re-activation of IMPACT.

Over the past year, IFPMA has also been joined by a number of other associations in the effort to stem the flow of counterfeit medicines. The Hong Kong Association of the Pharmaceutical Industry, the French Pharmaceutical Companies Association and the European Federation of the Pharmaceutical Industries and Associations have engaged in initiatives involving the private sector and public to help reduce the risk of counterfeit medicines and harm to patients.

Supplementing this work is the daily engagement of individual PSI member company's security teams. Their efforts account for upwards of 80 per cent of the illegal operations identified and then dismantled on a yearly basis. Their commitment of resources on a fulltime basis is one of the key factors in the successes that the public–private partnerships and recent anti-counterfeit initiatives.

PHARMACEUTICAL SECURITY INSTITUTE ACTIVITIES

Finally, to assist these efforts, PSI engages in public–private efforts on data and training for the public sector. For example, it offers a range of products and services to both international and national law enforcement authorities. These include strategic products, such as its annual Situation Report. In these reports, the nature and global scope of counterfeiting of medicines is defined and data collated. In addition, PSI arranges testing of suspect medicines through well-established contacts among the laboratory personnel of its members. As well, PSI has facilitated law enforcement efforts during searches by securing the participation of expert level, private sector manufacturing representatives at the time of the search to assist public authorities.

On a training level, PSI has conducts training and seminars on issues relating to counterfeit drugs. This has been done in more than 40 countries, working in close collaboration with national law enforcement authorities. Indeed, the scope of training can be large: for example, in 2010, over 600 officers were trained by PSI and its member's security teams in one country alone. These public–private strategies appear successful: 6 months later, these officers reported a fourfold increase in seizures of illegal medicines, preventing over 1 000 000 dosages of unsafe medicines from reaching innocent patients.

CONCLUSION

Global crime problems require global solutions. International cooperation among the private and public sector stakeholders has resulted in significant seizures and destruction of unsafe medicines. PSI members, along with PSI engagement with law enforcement on local, regional and global scales represent potential models for successful long-term public–private partnerships. The public sector and private entities must continue to seek out additional global opportunities to engage in cooperation to fight counterfeit drugs, as criminals will continue to exploit any perceived weaknesses in enforcement anywhere in the world.