The worldwide counterfeit drug market is huge and growing. The Center for Medicine in the Public Interest estimates that in 2010 the trade reaped around $75 billion, a 90 percent increase since 2005. Over the same period, the Pharmaceutical Security Institute (PSI), of which one of us is president, documented a huge increase in discoveries of counterfeit pharmaceutical products. In 2005, it recorded over 1,000 incidents; in 2010, it recorded more than twice that. The World Health Organization previously estimated that as much as 15 percent of the medicine in circulation around the world could be fake. These drugs occupy a wide spectrum of medications, and their quality is suspect; they can be mislabeled, tainted, adulterated, ineffective, or, in the worst cases, all of the above.

Given the lack of systematic, worldwide reporting, understanding the true scope of this public health problem is difficult. However, the broad strokes of it are well known. Traditionally, regions with weak regulatory structures, such as Africa, Latin America, and parts of Asia, have been both producers and consumers of counterfeit drugs. Multiple studies estimate that up to 50 percent of medicine in circulation in regions of Africa and Southeast Asia today is fake. And in 2009 alone, more than 20 million counterfeit pills were seized in China and Southeast Asia. 

Data from recent fake drug busts indicate that, these days, counterfeit medicines are mainly produced in China and India. But once bottled, they are no longer sold only in the developing world. According to PSI data, between 2005 and 2010, all corners of the globe saw more discoveries of counterfeit medicine (Asia experienced a 246 percent increase, Europe a 131 percent increase, the Near East a 105 percent increase, and North America a 77 percent increase). 

So even in such heavily regulated countries as the United States and Europe, fake drugs are now available -- primarily through online distributors. Without any oversight, people or businesses from virtually any country with Internet access can find and purchase pharmaceuticals from somewhere else in the world. In fact, the U.S. National Association of Boards of Pharmacy recently reviewed more than 9,600 online pharmacies and found that 97 percent were "not recommended," meaning that they did not comply with applicable laws and standards.

Last February, counterfeit Avastin, a widely used cancer drug, was detected in 19 U.S. medical practices in California, Texas, and Illinois. They apparently purchased what they thought was real Avastin from a foreign supplier known as Montana Health Care Solutions. They should have known better, as only a few distributors are authorized to sell Avastin in the United States. Montana Health Care Solutions' owner is also a key supplier of a large Canadian online pharmacy, Further investigations revealed that the fake Avastin had traveled through a number of countries, including Turkey, Egypt, Switzerland, and the United Kingdom, before reaching the United States. 

The counterfeit medicine market has not only grown in geographical reach; it has become broader, encompassing an ever wider range of medical products. Early counterfeit drug busts most commonly uncovered fake lifestyle drugs -- primarily medicines for sexual dysfunction. However, recent research and drug seizure data have shown that copies of all types of drugs are now readily available, with lifesaving treatments for noncommunicable diseases making up an increasing share of the market. For example, PSI has found a huge jump in discoveries of counterfeit drugs for cardiovascular disease (196 percent), central nervous system problems (119 percent), genitourinary issues (132 percent), and metabolic disease (110 percent). 

Drugs that treat noncommunicable diseases are expensive, in high-demand, and used over long periods, making them a lucrative target for counterfeiters. No wonder, then, that the high-profit, low-risk counterfeit drug trade is populated by organized criminal outfits, including the Russian mafia, the Chinese triads, the Colombian drug cartels, and Mexican gangs. The case of two Florida ex-convicts, Domingo Gonzalez and Julio Cruz, who generated around $10 million selling counterfeit Lipitor, highlights the attractiveness of this illicit business.

To be sure, research data on the illegal drug trade is limited, because detection is difficult and there are reporting biases across regions. Nevertheless, there is no question that counterfeit medicines are a huge and growing problem, the human costs of which are immense. Patients the world over have suffered injury, nontreatment, and death. High-profile cases include individual tragedies -- such as the death of the 18-year-old American Ryan Haight, who in 2001 overdosed on prescription drugs he had purchased online -- to public health disasters. During a 1995 meningitis outbreak in Niger, for example, 50,000 people were accidentally inoculated with fake vaccinations. 2,500 of them died. And over the last decade, hundreds of children have died from tainted counterfeit cough syrup. 

Global policy has not kept up with the burgeoning counterfeit drug trade. Specifically, cooperation on the illegal trade has gotten caught up in the battle over intellectual property rights (IPR) among public health organizations, countries, civil societies, and pharmaceutical manufacturers. Although this debate centers mostly on generic medicines, illegal copies have been taken along for the ride. On one side, industry representatives argue in favor of harsh penalties for all potentially IPR-infringing medicines, including unapproved versions. On the other side, several nongovernmental organizations and developing countries complain that such enforcement would unduly impede the poorest countries' access to essential medicines. Complicating matters is that there is no real global consensus on what "counterfeit" means, and laws to combat such fraud are a patchwork at best. 

With limited results, the World Health Organization has attempted to tackle the fake drug problem on a global level. One program, WHO IMPACT (International Medical Products Anti-Counterfeit Taskforce), brought together international and nongovernmental organizations, enforcement agencies, pharmaceutical manufacturers associations, and drug and regulatory authorities to better coordinate action against counterfeiters and those who sell their products. Initial results have been encouraging. IMPACT operations focused on targeting illicit sale and production (Operation Storm in Southeast Asia and Operation Cobra in West Africa), disrupting counterfeit transnational crime (Operation Mamba in Tanzania and Uganda), and illegal online sales (Operation Pangea in multiple countries) led to the seizure of millions of counterfeit pills and numerous arrests. 

But the future of IMPACT is in question. Some WHO member states, including India and Brazil (both top producers of generic drugs) and other developing countries, have questioned whether WHO can rightly take on enforcement operations. A recent intergovernmental working group's report suggested a number of paths forward, including a moratorium on activities, disengagement, or possible reform of IMPACT, without settling on one recommendation. The fact is that India and Brazil have a point: WHO is not a global law enforcement agency, which has made it difficult for the body to tackle the fake medicine trade. 

A better institutional bearer for the fight against counterfeit drugs could be the UN Office on Drugs and Crime (UNODC), which specializes in combating the trafficking of illicit drugs; fighting crime, corruption, and terrorism; and providing assistance for criminal justice systems. Those tasks have much in common with halting the trade of counterfeit medicines. UNODC's expertise could logically extend to coordinating and collecting information from global law enforcement activities, patient education, fighting transnational crime, assisting in criminal prosecutions, combating drug-related cybercrime, and developing national legislation and international binding agreements on the criminalization of counterfeit medicines. Already, Argentina, Chile, Costa Rica, El Salvador, Kenya, Lebanon, Mexico, and Nigeria have sponsored a draft resolution requesting UNODC to coordinate with other agencies to take up the task. 

UNODC's efforts would ideally be supported by the International Criminal Police Organization. Interpol could take on law enforcement training, capacity building, investigations, enforcement, and prosecution -- all to fight counterfeiters and their trade networks. Interpol is already experienced in tracking down and seizing large caches of dangerous drugs, as part of the recent Operation Pangea IV, which resulted in dozens of arrests globally and seizures of $6.3 million worth of narcotics, including antibiotics, antidepressants, anticancer, and lifestyle drugs such as erectile dysfunction and weight loss pills.

With UNODC and Interpol handling the policy and enforcement aspects of combating counterfeit drugs, WHO would be freed up to operate as the technical and research agency that it is, assessing and recommending measures to deal with public health issues arising from counterfeit medicines. For example, WHO could concentrate on improving access to safe medicines, strengthening health systems for better surveillance, developing monitoring and evaluation protocols, and studying the epidemiology of dangerous counterfeit drugs. 

Such a setup would effectively sideline the debate over IPR, because, with UNODC and Interpol handling the other aspects of the campaign against counterfeit medications, WHO could objectively identify public health dangers and relate its findings to its partners without consideration of property rights. Meanwhile, the World Trade Organization and the World Intellectual Property Organization would be responsible for hearing trade and IPR disputes. Such division of labor would allow each agency to leverage its own particular strengths and resources, and therefore fight the good fight more effectively.

All stakeholders have an interest in combating counterfeit drugs, and with international consensus behind them, organizations such as WHO, UNODC, and Interpol would have a powerful mandate to make a real difference. State governments, so far caught up by domestic commercial interests (including both brand and generic manufacturer concerns) should support a better framework for cooperation and coordination, because the counterfeit drug trade is global, and no country is insulated from its devastating impact on health. They should agree to internationally binding norms for the regulation of counterfeit medicines. It is a serious crime -- like murder, battery, smuggling, theft, drug abuse and fraud -- and should be treated as such. Public health ministers and civil society should lead the call for these reforms, given that the lives and health of all citizens are at stake. 

The counterfeit drug trade is a tremendous global health problem, threatening millions of lives worldwide. If agencies do not come together to end it, criminals will continue to meet growing demand and reap profits as everyone else suffers. If they do come together, the battle against perhaps the most menacing public health and patient safety threat of this generation can be won, and all of us can be assured that the medicines we use are safe.

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  • TIM K. MACKEY is a Senior Research Associate at the Institute of Health Law Studies at the California Western School of Law and a Ph.D. student in the Joint Doctoral Program in Global Health at the University of California, San Diego, and San Diego State University. BRIAN A. LIANG is Executive Director of the Institute of Health Law Studies and Director of the San Diego Center for Patient Safety. THOMAS T. KUBIC is President and Chief Executive Officer of the Pharmaceutical Security Institute.
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