A growing headache: the prevalence of international counterfeit pharmaceutical trade in developing African nations.

• Author: Chaves, Amanda

"It is not a problem of one person, it is a problem of all people. It is not a problem of one country, it is a problem of all nations." (1)

1. INTRODUCTION

   In 1995, a meningitis epidemic struck Niger, a developing African nation. (2) The government of Nigeria, Niger's northern neighbor, donated 88,000 doses of meningitis vaccine to halt the epidemic. (3) Consequently, 2500 people died because the coveted drug was counterfeit and did not contain the purported vaccine. (4) Counterfeit drug trade is an increasing problem in developing countries. (5) Poor drug regulation and enforcement, the prevalence of unregulated markets, and citizens' inability to afford prescription prices are the main causes of the problem. (6) Although counterfeit drug trade is a global problem, the effect on developing nations is of particular importance, especially in African nations where expensive drugs are needed in vast quantities to combat widespread diseases, such as malaria and HIV/AIDS. (7) In response to the prevalence of counterfeit drugs, the World Health Organization (WHO) created an international partnership called the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) to eliminate counterfeit drug transactions worldwide; however, a multilateral treaty regulating counterfeit pharmaceuticals on the international level does not exist. (8)

   This Note contends that IMPACT's extensive plan of collaborating on the international level and coordinating counterfeit drug regulations, achieved through legislation and national awareness, will not, by itself, be effective in developing African nations with weak regulatory structure. (9) A more effective solution, therefore, would be to enact a multilateral anti-counterfeiting treaty. (10) Part II explores the global recognition of the public health crisis caused by the prevalence of counterfeit drugs, as well as the adverse effects these drugs have on the health and well-being of the inhabitants of developing African nations. (11) Part III discusses domestic strategies implemented in developing African nations to hinder counterfeit drug trade inside their borders, as well as current international strategies and proposals. (12) Part IV analyzes the international community's answer to the pervasive counterfeit controversy, which calls for collaboration on the international level and coordination of counterfeit drug regulations. (13) In addition, Part IV proposes the enactment of a multilateral anti-counterfeiting treaty similar to the existing treaties regulating narcotics and psychotropic substances to effectuate the changes IMPACT seeks. (14)

2. THE COUNTERFEIT DRUG PANDEMIC

   1. Recognition as a Global Public Health Issue

      The prevalence of counterfeit drugs worldwide is an increasingly pressing global public health issue. (15) Counterfeit drugs come in a variety of forms and all are considered illegal and medicinally unreliable. (16) The WHO defines a counterfeit drug as "a medicine, which is deliberately and fraudulently mislabeled with respect to identity and source." (17) This definition encompasses both branded and generic medicinal products. (18)

      Counterfeit drug trade is a global problem and affects nations in all stages of development. (19) Developing nations, however, suffer the greatest detriment because of insufficient or weak regulatory guidelines. (20) Insufficient regulatory systems and ineffective government enforcement result in the inability to control the type and quality of pharmaceuticals entering the sales market. (21) Often, the production of counterfeit pharmaceuticals begins in countries where patent laws do not exist, or are not enforced. (22) Consequently, unregulated markets flourish in developing nations, especially those on the continent of Africa, where there is no governmental impetus to change the status quo. (23)

      Counterfeit drug trade is extremely profitable because of the demand for affordable prescription drugs worldwide. (24) The vast majority of counterfeit drugs produced are replicas of widely used pharmaceuticals. (25) Patented drugs are targeted by counterfeiters who produce counterfeit generics, which can be created either by replicating the process used by the patent holder or by "chemical analysis" of the patented drug and "development of alternative synthetic routes." (26) The most popular counterfeit pharmaceuticals in developed nations are those that lower cholesterol, while drugs that treat malaria, HIV/AIDS, and tuberculosis proliferate in developing countries. (27) In addition, the presence of counterfeit drugs in developing nations is exacerbated by the ease with which drugs are manufactured and through increased use of the internet. (28) Currently, counterfeit drugs account for approximately thirty percent of all medicine sold in the majority of developing African nations. (29) To date, many of these nations remain incapable of implementing effective changes in the war against counterfeit drugs. (30)

   2. Counterfeit Can Kill

      The prevalence of counterfeit drugs affects the health and well-being of unsuspecting consumers worldwide, but inhabitants of developing nations are hit the hardest. (31) Many consumers in developing nations lack adequate knowledge to distinguish a genuine drug from its counterfeit reproduction. (32) Consequently, the urgent need for affordable medicines in disease ravaged developing countries, in conjunction with inadequate knowledge and insufficient regulatory mechanisms, facilitates the continuous expansion of counterfeit drug trade. (33)

      Additionally, the impoverished inhabitants of developing nations are prone to illnesses, such as malaria and HIV/AIDS, partially because of substandard living conditions and therefore, are more likely to suffer from the adverse effects of counterfeit drugs. (34) The harmful effects of counterfeit drugs include worsening of the condition, creation of new symptoms, prolonged treatment, and sometimes death. (35) Furthermore, the overuse of counterfeit drugs, such as antibiotics, can lead to the growth of drug resistant strains, such as malaria, which places entire populations at risk. (36)

      Among African nations, Nigeria is the leading recipient of counterfeit pharmaceuticals, but it does not wage the counterfeit war alone. (37) Most health care systems in these developing countries suffer because national economies are in deplorable condition. (38) Many lack the required resources, both financial and in personnel capacity, to provide adequate services for the population. (39) Unfortunately, corrupt and self-serving individuals with little or no pharmaceutical education capitalize on the scarcity of medicinal supplies through the sale of counterfeit drugs. (40)

3. SMALL STEPS TOWARD ERADICATION

   1. Regulatory Dearth Leads to Disaster

      In comparison to developed nations, such as the United States, many African nations have weak regulatory structures. (41) Furthermore, many African nations are lead by corrupt government regimes that fail to regulate counterfeit drug trade. (42) In addition to government corruption, government sympathy toward the local business person who earns a livelihood by selling counterfeit drugs results in a failure to recognize and prosecute those engaging in the counterfeit drug trade. (43)

      In an attempt to combat the increase in counterfeit drug transactions, Nigeria set an example by creating a governmental agency geared toward implementing anti-counterfeiting regulations. (44) This type of legislation, however, has proved largely ineffective because the minor penalties imposed are an inadequate deterrent from the highly profitable business of counterfeit drug trade. (45) Additionally, the rapid sale and distribution of counterfeit pharmaceuticals contributes to the difficulty in detecting their origin. (46)

      Although developing nations are aware of the problems posed by counterfeit pharmaceuticals, few have enacted legislation pertaining specifically to counterfeit drugs. (47) For example, the government of Nigeria issued the Counterfeit and Fake Drugs Decree of 1989 (Miscellaneous Provisions), which prohibits and penalizes the production and sale of counterfeit drugs. (48) The Decree, however, encompasses all counterfeit drugs, which is defined as any drug that is not what it claims to be, and does not single out counterfeit pharmaceuticals as problematic. Furthermore, many countries do not distinguish between counterfeit trade in pharmaceuticals and counterfeit trade in other types of goods, penalizing all counterfeit crimes in a uniform manner.

   2. NAFDAC Leads the Anti-Counterfeit Revolution in Africa

      The Nigerian Federal Ministry of Health established the National Agency for Food and Drug Administration and Control (NAFDAC), headed by Dr. Dorothy "Dora" Akunyili, to monitor the quality of products imported into and exported from Nigeria. (51) In 2002, NAFDAC began the registration and certification of all pharmaceuticals available on the Nigerian sales market. (52) NAFDAC implemented regulations pertaining to both domestic and imported drugs. (53) Currently, non-compliance with registration and certification regulations results in either rejection of the registration application or delayed registration. (54) Thus far, NAFDAC has proved largely effective in decreasing the percentage of counterfeit medicines present in Nigeria. (55)

      Under the leadership of Akunyili, NAFDAC has significantly decreased the amount of unregistered drugs available in Nigerian markets. (56) The agency has successfully closed down various counterfeit markets and curtailed domestic importation of counterfeit drugs. (57) Additionally, Akunyili used unconventional methods to further increase the public awareness of counterfeit drugs, including publicly burning confiscated drugs and establishing writing competitions to educate the younger populace on the dangers associated with counterfeit medicines. (58) At the 2008 Conference of Regulatory Heads and...