U.S. Food and Drug Administration
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The article explores why--when the counterfeiting of medicines is so prevalent, hard to detect and quietly dangerous or fatal--it remains totally unaddressed and therefore legal in international criminal law. It is argued that criminalizing the counterfeiting of medicines on an international scale would present no legally insurmountable barriers, and would offer significant advantages over the current national-scale approaches. The authors propose a legal definition of 'counterfeit', canvass the current legal doctrines that could be arrayed to better criminalize medicine counterfeiting, including classifying the severest instances as crimes against humanity, and explain the mechanisms necessary to close the jurisdictional gaps that are currently exploited by organized criminals who trade in counterfeit medicines across borders. They suggest that a counterfeit medicine treaty should be drafted under the auspices of the World Health Organization, and illustrate the feasibility of doing so with existing and developing treaty law on another health danger, tobacco.
The counterfeiting of medicines is a global public health crisis. Recent estimates are that perhaps 15% of the global medicine supply is counterfeit, while in developing regions of Africa, Asia and Latin America over 30% of the medicines on sale may be counterfeit. It is a trade that kills. Even medicines sold for notoriously deadly diseases such as malaria are faked. In some countries, the evidence is that fully half of anti-malarial treatments sold are counterfeits.
Like the counterfeiting of money, the counterfeiting of medicines is highly globalized--pills are fairly easy to smuggle. But unlike the counterfeiting of money, the criminals who deal in counterfeit medicines do so with little fear and few consequences. For remarkably, there is today no international legal framework to pursue and punish those who counterfeit medicines and traffic them across borders.
Yet, there is strangely little outrage at this globalized, deadly evil. As the International Federation of Pharmaceutical Manufacturers and Associations so pithily notes, 'If you're caught with a kilo of heroin at a border crossing you'll go to jail for a very long time. If you're caught with a kilo of counterfeit medicines, that penalty may be the same if you're caught with a kilo of counterfeit T-shirts.' The problem is one of transnational jurisdiction, or more accurately, the lack of it. Currently, if a counterfeiter from country A produces and exports useless, perhaps deadly, drugs to country B, normally only country A has the authority to prosecute the criminal for counterfeiting because that criminal act occurred on its territory. Country B, despite having its citizens victimized, usually has little criminal jurisdiction over the matter. Country B might have criminal jurisdiction over acts ancillary to the counterfeiting--such as fraud, or smuggling ç but that is not the same crime; it may not even be committed by the same person; and odds are that it will not carry an appropriate penalty. And with no international agreement to treat medicine counterfeiting as a serious crime, judicial and police cooperation between countries A and B cannot be taken for granted. Impunity for medicine counterfeiters is largely the result.
Plainly, knowingly making fake medicines that do not help people, or that harm and kill them, ought to be considered a more serious transnational crime than it is. Other evil acts that deliberately endanger life on a transnational, widespread and systematic basis--for example, terrorism or hijacking--receive a far stronger legal treatment today. So too does the counterfeiting of currency, which though an age-old scourge, became an international crime in 1929. On that occasion, the international legal community declared that those who faked money should, 'without ever being allowed impunity,' be placed under universal jurisdiction and made liable to prosecution in any country, not just the country where the counterfeiting took place. Almost a century after this development, humanity and the defence of public health requires doing likewise for the trade in counterfeit medicines.
This article is an exploration of why--when the counterfeiting of medicines is so prevalent, hard to detect and quietly dangerous or fatal--it has escaped the attention of international criminal law.We demonstrate that criminalizing the counterfeiting of medicines on an international scale would present no legally insurmountable barriers, and would offer significant advantages over the current national-scale approaches. This article is organized in three parts. In Section 2, we describe the international nature of the counterfeit medicine trade and explain how existing laws are permitting deadly counterfeiting to go unpunished. In Section 3, we canvass the legal doctrines that could be arrayed to better criminalize medicine counterfeiting, ranging from the fundamental legal definition of 'counterfeit', to the possible imposition of a new crime against humanity for the most egregious offences. Finally, in Section 4, we discuss the international governance mechanisms, particularly at the World Health Organization (WHO), available to negotiate and agree upon a counterfeit medicine treaty.We conclude with some critical observations on current public health politics, which are preventing action.
Roger Bate is the Legatum Fellow in Global Prosperity at AEI. Amir Attaran is an associate professor in the faculties of law and medicine at the University of Ottawa, Canada. Megan Kendall is a faculty of law at the University of Ottawa, Canada.