In 2001, when Dora Akunyili was appointed director general of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), over half of all drugs in the Nigerian market were counterfeit. Under Akunyili's leadership, NAFDAC reduced that number to under 20 percent in 2006. AEI and the Heritage Foundation recently hosted Akunyili to discuss the problems counterfeit drugs pose to the international community and the strategies that have made NAFDAC's efforts successful thus far.
Counterfeit drugs--those with none of the active ingredient, that have expired and been relabeled, or that have a different active ingredient than what is stated on the label--pose grave risks not only to the health of those who take them but also to public health. Substandard drugs--those not willfully mislabeled but containing an insufficient amount of the active ingredient--are, according to Akunyili, even more dangerous since they rarely cure the patient but build resistance across populations, fostering strains of diseases that require increasingly powerful and costly drugs to treat them.
Counterfeiters and distributors in Nigeria are attracted to the counterfeit drug trade because it is lucrative and relatively low-risk, Akunyili said. Those who are caught usually get a slap on the wrist and immediately return to their illegal activities. To combat these criminals, NAFDAC has cracked down on dealers and hawkers, closed drug outlets where fake drugs are sold, and confiscated drugs from sellers who refused to report the origin of their goods. "We also have a strategy of mopping up what is already in circulation--true, sustained, systematic surveillance and testing and retesting what we had already registered," she said.
At AEI, Akunyili discussed several other strategies that she implemented that have seen positive results, including staff training and retraining, regulatory restructuring, and an extensive "public enlightenment" campaign. "We realized that the first step in solving a problem," she said, "is to sit down and accept that there is a problem; to tell people that there is a problem so that people will stop being deceived; to sensitize people to be vigilant about what they buy, what they use, and what they eat." She has also beefed up surveillance at seaports and airports, monitored drug manufacturers in Nigeria, and streamlined registration of legitimate drugs. China and India are the main sources of the fakes found in Nigeria, and NAFDAC has independent analysts monitoring these countries in an effort to reduce the number of counterfeit drugs they export to the Nigerian market.
The problem of counterfeit drugs is global, Akunyili said. Other countries are complicit in shipping counterfeit and substandard drugs to developing countries, and these drugs are even reaching markets in developed countries. While Nigeria is doing its part to eradicate fake drugs, it cannot manage the situation alone. Akunyili called for international collaboration: "The negative impact of counterfeit drugs knows no boundaries. Resistant strains of microorganisms do not need a visa to travel."
The event was moderated by AEI's Roger Bate, who has done extensive field research on counterfeit drugs in the developing world. Bate is the author of Making a Killing: The Deadly Implications of the Counterfeit Drug Trade (AEI Press, May 2008), which explores how the worldwide market for fake drugs works--and how to arrest the trade.
Making a Killing is full of vivid and disturbing anecdotes, such as the Russian pharmaceutical oligarch who made millions distributing fake drugs through legitimate supply chains and the vendors openly selling unlicensed drugs to unwitting consumers in a Senegalese street market. Bate goes beyond mere anecdotes, however; Making a Killing assembles all the known official estimates of this shadowy practice.
How can counterfeiters be stopped? By improving health infrastructures and improving access to essential medicines, developing countries can reduce the incentives for patients to buy the cheaper fakes. Developed countries can step up inspection of supply chains and devote more resources to investigations. Bate also describes multilateral efforts to coordinate individual countries' actions. Furthermore, he writes, "the private sector has powerful incentives to stem the deluge of fakes," and pharmaceutical companies and pharmacists are developing verification technology to protect the supply chain.
To further stem the flow of counterfeits, Bate recommends "embrac[ing] free trade with patent protection," making the supply chain transparent, increasing postproduction drug surveillance, and educating consumers about avoiding fakes.