Review
Understanding and fighting the medicine counterfeit market

https://doi.org/10.1016/j.jpba.2013.01.009Get rights and content

Abstract

Medicine counterfeiting is a serious worldwide issue, involving networks of manufacture and distribution that are an integral part of industrialized organized crime. Despite the potentially devastating health repercussions involved, legal sanctions are often inappropriate or simply not applied. The difficulty in agreeing on a definition of counterfeiting, the huge profits made by the counterfeiters and the complexity of the market are the other main reasons for the extent of the phenomenon. Above all, international cooperation is needed to thwart the spread of counterfeiting. Moreover effort is urgently required on the legal, enforcement and scientific levels. Pharmaceutical companies and agencies have developed measures to protect the medicines and allow fast and reliable analysis of the suspect products. Several means, essentially based on chromatography and spectroscopy, are now at the disposal of the analysts to enable the distinction between genuine and counterfeit products. However the determination of the components and the use of analytical data for forensic purposes still constitute a challenge. The aim of this review article is therefore to point out the intricacy of medicine counterfeiting so that a better understanding can provide solutions to fight more efficiently against it.

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

References (125)

  • P.Y. Sacré et al.

    Comparison and combination of spectroscopic techniques for the detection of counterfeit medicines

    J. Pharm. Biomed. Anal.

    (2010)
  • C.Q. Hu et al.

    Establishment of a fast chemical identification system for screening of counterfeit drugs of macrolide antibiotics

    J. Pharm. Biomed. Anal.

    (2006)
  • C.L. Flurer et al.

    Chemical profiling of pharmaceuticals by capillary electrophoresis in the determination of drug origin

    J. Chromatogr. A

    (1994)
  • R.D. Marini et al.

    Reliable low cost capillary electrophoresis device for drug quality control and counterfeit medicines

    J. Pharm. Biomed. Anal.

    (2010)
  • P. De Peinder et al.

    Detection of Lipitor® counterfeits: a comparison of NIR and Raman spectroscopy in combination with chemometrics

    J. Pharm. Biomed. Anal.

    (2008)
  • Y. Roggo et al.

    A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies

    J. Pharm. Biomed. Anal.

    (2007)
  • F.E. Dowell et al.

    Detecting counterfeit antimalarial tablets by near-infrared spectroscopy

    J. Pharm. Biomed. Anal.

    (2008)
  • S. Trefi et al.

    Analysis of illegally manufactured formulations of tadalafil (Cialis®) by 1H NMR, 2D DOSY 1H NMR and Raman spectroscopy

    J. Pharm. Biomed. Anal.

    (2008)
  • Y. Roggo et al.

    Identification of pharmaceutical tablets by Raman spectroscopy and chemometrics

    Talanta

    (2010)
  • M. De Veij et al.

    Detection of counterfeit Viagra® with Raman spectroscopy

    J. Pharm. Biomed. Anal.

    (2008)
  • C. Gendrin et al.

    Pharmaceutical applications of vibrational chemical imaging and chemometrics: a review

    J. Pharm. Biomed. Anal.

    (2008)
  • M.B. Lopes et al.

    Determination of the composition of counterfeit Heptodin™ tablets by near infrared chemical imaging and classical least squares estimation

    Anal. Chim. Acta

    (2009)
  • Partnership for Safe Medicines, Counterfeit Drug Incident Encyclopedia, Partnership for Safe Medicines, Vienna, VA,...
  • International Medical Products Anti-Counterfeiting Taskforce (IMPACT)

    Counterfeit Drugs Kill!

    (2008)
  • World Health Organization

    Growing threat from counterfeit medicines

    Bulletin World Health Organization

    (2010)
  • J. Primo-Carpenter et al.

    Matrix of Drug Quality Reports on USAID-Assisted Countries, By the USP Drug Quality and Information Program

    (2009)
  • M.R. Roudaut

    Contrefaçon: un crime invisible

    Cahiers de la Sécurité

    (2011)
  • M. Shepherd

    Beef up international cooperation on counterfeits

    Nat. Med.

    (2010)
  • Organisation for Economic Co-operation and Development (OECD)

    The Economic Impact of Counterfeiting and Piracy

    (2008)
  • P.N. Newton et al.

    The primacy of public health considerations in defining poor quality medicines

    PLoS Med.

    (2011)
  • A. Attaran et al.

    Why and how to make an international crime of medicine counterfeiting

    J. Int. Crim. Just.

    (2011)
  • World Health Organization

    Medicines: Spurious/Falsely-Labelled/Falsified/Counterfeit (SFFC) Medicines, WHO Fact Sheet 275

    (2010)
  • World Health Organization

    What are Substandard Medicines?

    (2009)
  • World Trade Organization

    Agreement On Trade-Related Aspects Of Intellectual Property Rights (TRIPS), Article 51

    (2012)
  • Anti-Counterfeiting and Trade Agreement (ACTA), Section 3: Criminal Enforcement – Article: 2.14: Criminal Offenses,...
  • Swiss Federal Institute of Intellectual Property (IGE)

    Possibilities for Fighting Counterfeiting and Piracy

    (2009)
  • Swiss Penal Code

    Falsification de Marchandises (Falsification of Goods), Book 2, Article 155

    (2010)
  • Swiss Penal Code

    Blanchiment d’Argent (Money laundering), Book 2, Article 305bis

    (2010)
  • Swiss Penal Code

    Escroquerie (Fraud), Book 2, Article 146

    (2010)
  • Swiss Penal Code

    Organisation Criminelle (Criminal Organization), Book 2, Article 260ter

    (2010)
  • A. Seiter

    Health and economic consequences of counterfeit drugs

    Clin. Pharmacol. Ther.

    (2009)
  • P.N. Newton et al.

    A collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia

    PLoS Med.

    (2008)
  • F.M. Fernandez et al.

    Prevalence and detection of counterfeit pharmaceuticals: a mini review

    Ind. Eng. Chem. Res.

    (2008)
  • J. Harris et al.

    Keeping It Real. Combating the Spread of Fake Drugs in Poor Countries

    (2009)
  • R. Mukhopadhyay

    The hunt for counterfeit medicine

    Anal. Chem.

    (2007)
  • J. Harper

    European Alliance for Access to Safe Medicines (EAASM), European Patient Safety and Parallel Pharmaceutical Trade – A Potential Public Health Disaster?

    (2007)
  • F. Vanderdonck

    Counterfeit medicines: a threat to public health and safety

    Louvain Médical

    (2007)
  • European Alliance for Access to Safe Medicines (EAASM)

    The Counterfeiting Superhighway

    (2009)
  • F.M. Jung

    Counterfeit protein drugs: how to discover and how to prevent?

    Off. J. Eur. Assoc. Hosp. Pharm.

    (2007)
  • Patients and Patents

    Global Growth of Counterfeit Medicines Threatens Patient Safety

    (2008)
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      Due to incorrect ingredients, the consequences can range from unexpected to allergic reactions [34]. Furthermore, it is impossible to assume that counterfeit API products will be subtherapeutic, because they may contain more than the stated amount, which increases the risk of adverse effects for drugs with narrow therapeutic indices [35]. They have financial ramifications for patients and their families, the country, and genuine medicine providers, as a result of a workforce that is frequently too ill to work or care for their families [11,36].

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