Advancements in technology have facilitated the production and distribution of larger quantities of counterfeited goods in shorter periods of time, and have made it easier for counterfeiters to profit while successfully escaping detection. The FBI calls counterfeiting the crime of the 21st century (United Nations Interregional Crime and Justice Research Institute, 2003) and the trafficking of counterfeit goods has become one of the world’s largest and most rapidly growing criminal enterprises, with the International Anti-Counterfeiting Coalition (IACC) estimating a value of more than US$ 600 billion annually (IACC, 2009).
Today, counterfeit goods are found throughout the world; wherever there is a demand for a product, counterfeiters are quick to fill the niche. The kinds of counterfeited products identified by the Organization for Economic Cooperation and Development (OECD) include clothing, auto parts, money, electronics, food, water, and pharmaceuticals (OECD, 2007).
The damage caused to society by counterfeit goods varies in scope and scale depending on the product and its range of distribution. However, of all the different counterfeit goods produced, none are more potentially damaging than those affecting public health and safety, such as pharmaceuticals. The World Health Organization (WHO) estimates that of the 1 million malaria deaths that occur each year, 200,000 are the result of counterfeit anti-malarial drugs.
Analysts state that counterfeit drugs for tuberculosis and malaria kill 700,000 people every year. Although the counterfeit drug trade is wide in scope, it has a more devastating public health effect on developing countries, like those in Southeast Asia and Africa, where there are intense demands for inexpensive lifesaving drugs.
Before discussing counterfeit drugs, it is necessary to define the term. Because the extent of the problem differs from country to country, the concept of “counterfeit drug” varies. For the purpose of this paper we will use the definition developed by the WHO (2009):
A counterfeit medicine (drug) is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.
Traditionally, the most common types of counterfeit drugs were those described as “lifestyle drugs” such as those used to treat erectile dysfunction or baldness. However, recently there has been an increase in the counterfeiting of “lifesaving” drugs meant to prevent or treat asthma, malaria, cancer, HIV/AIDS, tuberculosis, blood pressure and heart conditions, diabetes, and severe diarrhea. In Africa, the three forms of drugs most frequently counterfeited are those aimed at malaria, HIV/AIDS, and tuberculosis.
The counterfeit drug epidemic currently threatening many African countries is gaining international attention. World leaders are beginning to realize that the counterfeit drug trade is not a local problem faced by a few developing countries, but a global one with far-reaching consequences. Surprisingly, even with an estimated US$ 39 billion annual world market (Pitts, 2005), little is known about its geographic extent. Organizations such as the UN, the WHO, the World Trade Organization, and the OECD, and some government agencies, such as Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), have collected some startling statistics over the past few years. Armed with these data and following some high-profile arrests, these organizations have made public the impact of the counterfeit drug epidemic in developing countries and the steps that leaders are taking to bring the counterfeiting problem under control.
According to the WHO, a significant fraction of the world’s drug supply is counterfeit. Estimates of counterfeit drugs range from 10 to 15 percent for the world drug supply, to more than 30 percent of all medicine sold in Africa, and up to 70 percent of the drugs sold in Nigeria WHO, 2008; Primo-Carpenter, 2009). In 2005 the estimated US$ 39 billion global market for counterfeit drugs was growing at 13 percent annually, with a projected increase of 92 percent to reach US$ 75 billion by 2010 (Pitts, 2005). It is important to acknowledge, however, the difficulty of measuring the extent of counterfeiting with any degree of certainty. The clandestine nature of much of the manufacture, distribution, and sale of counterfeits make creating an appropriate sampling frame challenging, thereby inhibiting the accuracy of prevalence estimates. It is difficult to assess how well the sample drawn to test for counterfeits represents the true population of pharmaceuticals in the market.
A Guest Editorial