Counterfeit medical products are an enormous problem. In low- and middle-income countries, about 10% are substandard and falsified (SF) – amounting to an economic toll of up to $200 billion a year, contributing to antimicrobial resistance, and causing unnecessary suffering and death.
This is clear for instance with malaria. After decades of development, a malaria vaccine now exists. And treatments for malaria are so reliable that deaths from malaria are avoidable. Yet the proliferation of SF medicines risks reversing the hard-won progress on curbing malaria.
It’s been estimated that 116,000 people die in sub-Saharan Africa each year because of counterfeit malaria drugs. In other words, over a quarter of all deaths from malaria are linked to fraudulent meds.
It can be fiendishly difficult to detect these medicines. Sales over the internet, where half of the medicines sold may be counterfeit, are poorly regulated, and physical addresses can be obscured.
The international nature of the medical supply trade also provides cover to smugglers. According to “Shine Your Eyes,” a working paper authored by Samantha McBirney of the RAND Corporation, SF pharmaceutical products in sub-Saharan Africa may be produced domestically or as far afield as India and China. With over 30 exchanges between manufacture and end use, the supply chain is challenging to trace. Customs authorities in Benin have reported that some smugglers remove backseats of cars to make room for illicit medicines, sometimes hiding them in sacks of food.
The products themselves may look very convincing, even when they contain antifreeze or salt rather than active pharmaceutical ingredients. Sophisticated counterfeiters can reproduce pill packages even down to the holograms, leaving only very subtle visual tells like misspellings and faded colors.
Much of the advice for beating back SF meds relies on individual consumers to become pharma detectives. It’s suggested that people avoid loose pills, only frequent reputable pharmacies, and use technological tools such as blockchain, barcodes, and phone apps to verify the validity of their medicines.
These internet-based features are a welcome addition to the arsenal for fighting fake pills. But they apply mainly to well-heeled, tech-savvy, English-speaking consumers who have smartphones, knowledge of the problem, and the means to search out the safest products. Someone in a remote location who depends on an open-air market for the cheapest medicines may not have the same resources and options.
Besides, awareness doesn’t do much good if safe medicines simply aren’t available and accessible. As biotech executive Adham Yehia has written for the Financial Times, “In Nigeria’s medical profession we possess the knowledge and the dedication but we lack the vital drugs…the tragic irony is that, actually, we often do have the medication. It’s just that it can be impossible to find. And if you do manage to locate it in-country, you worry about provenance, storage conditions and, most importantly, the price. Drugs in Nigeria cost up to 64 times the international price.”
So in concert with awareness, institutional strengthening is badly needed in at least three areas: law enforcement, medical supply, and trade regulation. Penalties for counterfeiters and smugglers are so limited that they’re not an effective deterrent to engaging in this lucrative trade. National authorities for regulating medicines are also under-resourced, creating many openings for illegal and unsafe medicines to pass through to patients. Pharmacists themselves may not have enough training about how to authenticate medicines.
And, as criminologist Gernot Klantschnig has told the BBC, “There must be a parallel effort to fix vulnerabilities in health markets in West Africa; in some countries, wealth has become a determining factor for gaining access to quality healthcare and drugs.”
The good news is that Nigeria, which is both the biggest market for counterfeit drugs and the most malaria-burdened country, has made great strides in tamping down on SF drugs. According to “Shine Your Eyes,” fake medicines accounted for 67% of all medicines in 2001, when Nigerian authorities started their war on counterfeit drugs. The reputation of medicines from Nigeria was so poor that Cameroon and Niger had banned the entry of meds from their more populous neighbor. Remarkably, just three years later, the proportion had dropped to 16%.
It’s been uneven, yet there has been progress on fake antimalarials. How was this reduction accomplished? For one thing, the National Agency for Food & Drug Administration (NAFDAC) in Nigeria looked outside itself. The agency built relationships with counterparts in India and China – major source countries for fake medicines – to step up inspections before these products made it out of the country, and to increase penalties for counterfeiters. (In some cases, these went too far, extending to death sentences.)
As another line of defense, NAFDAC provided testing devices to border officials, and customs workers destroyed huge numbers of fraudulent medicines on the verge of entering the country.
Within the country, NAFDAC required authorized drugs to have a registration number, and expanded training for community pharmacists that covered identifying and reporting falsified medicines. Certain technologies have been especially helpful for manufacturers and regulators. According to “Shine Your Eyes,” “While there are countless different technologies that could be used in this sphere, the most mature digital anti-counterfeit technologies have proven to be mobile and RFID-based solutions, which enable more robust detection, authentication, and track-and-trace.”
Fake medicines remain a persistent problem even in Nigeria, which has put so much effort into undercutting fake drugs. To avoid a graveyard of well-meaning apps that have limited utility, and to avoid backsliding in the fight against malaria, Nigerian organizations will need to sustain this kind of multi-pronged approach – while ensuring that quality medicines and information are available to the neediest.