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The growing global problem of counterfeit medication poses a crippling risk to healthcare systems in developing nations. Though authoritative studies are few and far between, the World Health Organization (WHO) estimates that counterfeit drug prevalence rates fall between 10% to 30% in the developing world, compared to 1% or less in industrialized nations. The U.S.-based Center for Medicines in the Public Interest (CMPI) projects that by 2010, US $75 billion worth of counterfeit drugs will be sold annually. Fake drug sales are expected to grow at 13% yearly till 2010, a rate significantly higher than the estimated 7.5% annual growth for genuine pharmaceutical commerce.1

Over the years, a number of hybrid solutions have been applied to this problem. In general, they can be classified as employing a combination of stepped-up regulatory enforcement and technological innovation. Being pioneers in technology, industrialized nations have typically enjoyed a good balance between these two key ingredients. Developing nations, however, are comparatively less-endowed and generally not in the position to invest vast amounts in the research and development needed to yield effective anti-counterfeit technologies. Thus, where such countries have chosen to tackle the fake drug problem, stepped up regulatory enforcement (syndicated raids and legal proceedings) is the only deployable tool.2

Nigeria offers a sterling example of the increased enforcement approach. In 2003, Interpol conducted a survey on the quality of drugs available in Lagos, Africa’s most populous city, and discovered that a harrowing 80% of the drugs available were fake.3 After a myriad of death threats, fire bombs, acts of vandalism and even an assassination attempt on the director general of the Nigerian drug regulatory body, the prevalence rate is believed to have dropped to 16% three years later. Those acts of aggression were in response to a well-executed stepped-up enforcement effort headed by the director general of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Dora Akunyili. Enforcement can be a very costly and life-threatening affair, putting additional stress on the meager national health budgets that typify several developing nations.2

Fortunately, the need for technological assistance to the enforcement-only approach has been identified, and a number of products have been developed by innovators in the first world. Since 1820, the U.S. Pharmacopoeia (USP) has aggregated a compendium of compound characteristics and testing suites, and over time, resourceful U.S. companies have risen to the task of providing technology solutions to rapidly detect fake drugs before they appear on shelves accessible to unwitting consumers.4 If spurious drugs happen to sneak by the stringent border entry checks, good supply chain management based on well-researched industry practices are employed to ensure that such products are kept out of the first world’s market. Yet, with this system in place, new challenges abound in industrialized nations due to internet-sourced drugs of questionable pedigree but at agreeable prices.

In response to the new challenges, an electronic drug pedigree tracking system has been tested in the U.S. that uses revolutionary Radio Frequency Identification (RFID) tag technology to facilitate mass-surveillance of genuine drugs as they filter through the supply chain from legitimate manufacturers to consumers. 5 In the near future, should the developed world pharmaceutical industry find the technology affordable6, first-world consumers will be able to purchase drugs with the confidence that a bill of lading could be produced (in-shop or online) showing the drug’s entire pedigree, authenticated by the appropriate trust networks and national authorities.

Developing nations are technologically well behind, primarily due to the fact that new anti-counterfeit technologies are oft beyond their means. History has shown that by the time such technologies are affordable, resourceful counterfeiters could have copied the technology, turning it into a great risk – consumers can have a false sense of security in "protected" counterfeit products. This trend is evidenced in the events that have led to the compromise of microprint, advanced product packaging, security inks, tabletting molds, unique blister packs and even holograms as fool-proof product security technologies.7

A Universal Right To Good Health »

Everyone deserves the right to good health – the WHO and the Universal Declaration of Human Rights stand by this. 8 Sadly, the path to that dream is littered with counterfeit drugs. If the vision is to be realized, it is necessary for willing developing nations to come up with innovative technologies based on their available resources to boost enforcement.

A balanced use of appropriate technology and efficient law enforcement could help Africa reach one of its Millennium Development Goals (MDG): curbing the increase and initiating a decrease the prevalence of malaria by 2015. In addition to taking over a million lives yearly, "malaria costs Africa US$12 billion in lost GDP every year and consumes 40% of all public health spending". 9 The WHO estimates that as many as 200,000 of those lost lives could be saved if all anti-malarials were genuine. 10 The corresponding public health cost savings in such a scenario could be of large economic benefit to the continent and its foreign donors.

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[1] Kirsty Barnes, “Systech offers solution in counterfeit drug war,” In-PharmaTechnologist.com, October 21, 2005. http://www.in-pharmatechnologist.com/Packaging/Systech-offers-solution-in-counterfeit-drug-war. Accessed on December 1, 2008. ↑ top

[2] Transcript of interview titled: “Cracking Down on Killer Drugs: Dora Akunyili and the Nigerian Success Story,” American Enterprise Institute, April 14, 2008. http://www.aei.org/events/filter.all,eventID.1700/transcript.asp. Accessed on December 1, 2008. ↑ top

[3] Nick Taylor, “Nigerian Counterfeit drug seizure,” In-PharmaTechnologist.com, May 29, 2008. http://www.in-pharmatechnologist.com/Processing-QC/Nigerian-counterfeit-drug-seizure. Accessed on December 3, 2008. ↑ top

[4] U.S. Pharmacopoea, “USP History,” http://www.usp.org/aboutUSP/history.html. Accessed on November 22, 2008. ↑ top

[5] Presentation at the “FDA Anti-Counterfeit Drug Initiative Workshop Public Meeting” by Thomas McPhillips, Vice President, U.S. Trade Group, Pfizer Inc. February, 2006. Accessible online: http://www.fda.gov/oc/meetings/rfid/McPhillips.ppt ↑ top

[6] Rick Lingle"RFID reluctance remains", Packaging World Magazine, December 2006 , p. 38 http://www.packworld.com/article-22458. Accessed July 25, 2009. ↑ top

[7] Newton PN, McGready R, Fernandez F, Green MD, Sunjio M, et al. “Manslaughter by Fake Artesunate in Asia—Will Africa Be Next?” PLoS Medicine Vol. 3, No. 6, e197 doi:10.1371/journal.pmed.0030197 ↑ top

[8] Counterfeit Drugs – Guidelines for the development of measures to combat counterfeit drugs. Department of Essential Drugs and Other Medicines, World Health Organization, Geneva, Switzerland. http://whqlibdoc.who.int/hq/1999/WHO_EDM_QSM_99.1.pdf. Accessed January 11, 2009. ↑ top

[9] Medicines for Malaria Venture, “MMV at a glance Newsletter,” September 2007, http://www.mmv.org/IMG/pdf/mmv07_Glance_reoranized_sept2007.pdf. Accessed November 10, 2008. ↑ top

[10] Ian MacKinnon, “South-east Asia awash with fake drugs,” The Guardian, February 22, 2007. http://www.guardian.co.uk/world/2007/feb/22/health.healthandwellbeing/print. Accessed November 10, 2008. ↑ top

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