ReviewUnderstanding and fighting the medicine counterfeit market
Graphical abstract
Highlights
► Medicine counterfeiting is an organized crime that has reached an industrial scale. ► Its roots are manifolds, and mostly based on deficiencies in the legal and enforcement framework. ► Reliable analytical methods are necessary and provide interesting insights into the phenomenon.
Introduction
Medicine counterfeiting is a serious crime. The term needs to be clarified and harmonized but it is apparent that the problem goes far beyond a simple intellectual property quarrel. Both branded and generic medicines are indeed targeted by counterfeiters. Moreover given its life-threatening potential, the phenomenon is even more serious than the counterfeiting of other goods. Every week new instances of counterfeit medicines are discovered around the world [1] and according to the World Health Organization (WHO) [2], 10% of the world's medicines are counterfeits. Interpol refers to the “big quantities seized and sophisticated criminal networks” [3]. The seriousness of the issue is also perceived by the industrialization and globalization of the phenomenon [4], [5], [6], [7]. Medicine counterfeiting has turned into a new branch of organized crime, and its links with other illegal traffics were established, together with its role in funding terrorist activities [5], [8]. Efficient measures need to be implemented in order to fight these criminals. Investigations may be on the increase but dismantling of the complex and shadowy counterfeit market remains a challenge. The definition of “medicine counterfeits” should be harmonized, so that domestic and international laws can be adapted and law enforcement strengthened. This paper aims to provide a clearer understanding and overview both of the phenomenon itself and the weapons at our disposal for fighting it.
Section snippets
Definitions and legal aspect
The definition of medicine counterfeiting, still debated, needs to be clarified [8], [9], [10]. The 1992 WHO definition has so far remained the worldwide reference, stating that “Counterfeit medicines are deliberately and fraudulently mislabeled with respect to identity or source” [2]. Some modifications have recently been proposed by the WHO, who would now rather use the term “spurious/falsely labeled/falsified/counterfeit (SFFC) medicines” [11]. Substandard medicines are another issue, since
Seriousness of the phenomenon
The number of reported counterfeit medicine cases seems to be rising [30] (Fig. 1). The Pharmaceutical Security Institute admits that these data may reflect increased awareness on the part of both the public and law enforcement authorities. However, the figures are probably underestimates or only the “tip of the iceberg” [5], [24]. As the trade is illegal, it is impossible to know how much is undetected [2]. Estimations of its current extent are nevertheless alarming and it is clearly a
Increasing awareness
Medicine counterfeiting is not new but it was only in the late 20th century that governments addressed the problem and conferences began to take place. In 1985 the WHO organized a conference in Nairobi that first drew attention to the issue [53]. The declaration of Rome resulted in 2006 in the creation of IMPACT, which brings together 193 member states and organizations such as Interpol [2], [54]. The American Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) also play
Conclusion
Medicine counterfeiting is a crime that has become transformed into a topical issue by the scale of its industrial development. Several kinds of counterfeit medicines currently plague society, including some devoid of any API and others stuffed with toxic compounds. The consequences are potentially disastrous and counterfeiting has already been responsible for many deaths. Although the apparent principal economic victim is the pharmaceutical industry the whole health system is actually
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