Poor-Quality and Counterfeit Drugs in Emerging Markets

The numbers were shocking, but they weren’t meant to be. Amir Attaran, DPhil, LLB, a panelist at Tuesday’s event at the American Enterprise Institute on poor-quality and fake drugs in emerging markets, reframed some statistics that had been discussed earlier.

What if, he said, 40% of the arriving flights at Dulles International Airport originated outside the U.S. and were unknown to air traffic controllers until each plane was on final approach? What if 7% of flights were using substandard engines?

Such statistics, of course, would be unacceptable to the American public and its government. But Attaran’s larger point was that we never have to worry about such things because there are policies, whether treaties or international organizations, that manage such regulation. Air traffic controllers are made aware of all inbound flights to the U.S., even for general aviation aircraft. And the European Union has banned hundreds of airlines for not meeting safety regulations.

That’s not the case with substandard or fake drugs.

Attaran, a professor at the University of Ottawa, said an international body to handle criminal conduct in the area of public safety is necessary before any substantive curbing of bad drugs can begin. For example, he said, if a resident of Canada exports fraudulent pharmaceuticals into the U.S., the Canadian government has no legal obligation to arrest the perpetrator. Until that happens, efforts to curb bad drugs are “extremely laudable but utterly unattainable,” he said.

But the problem of substandard and fraudulent drugs won’t merely be solved at the 30,000-foot level, as other panelists noted.

Patrick Lukulay, PhD, vice president of Global Health Impact Programs at the United States Pharmacopeial Convention, said poor regulation, an unmonitored market and an uninformed — i.e., unsuspecting — patient all add up to a deadly combination. And some problems aren’t even that broad; many companies mean no harm but lack the resources for quality control or proper equipment. Even, Lukulay said, installing air conditioners instead of air handling units represented a problem; air conditioners can carry particles to different areas and increase the risk of contamination.

Local health care delivery, legitimate and otherwise, may present a barrier also. Bernard Nahlen, MD, deputy coordinator of the President’s Malaria Initiative, noted that many areas affected by malaria assume that fevers equal malaria until proven otherwise. On a recent trip to Burma, Nahlen noticed local fisherman purchasing bags of pharmaceuticals (all of unknown quality) from salesman.

“These young men were at the mercy of itinerant drug salesmen,” Nahlen said, “and I think we can do better than that.”

Better oversight from non-governmental organizations would help too, said Richard Tren, co-founder and executive director of Africa Fighting Malaria.

There are reasons for hope, however. Andreas Seiter, MD, senior health specialist and expert in pharmaceutical policy and management at the World Bank’s Health, Nutrition and Population Anchor, noted a program in Nigeria that was able to reduce counterfeits and substandard drugs in urban areas. Scaling the program nationwide, at the very least, could “name and shame” bad operators but would cost $20 to $30 million. So far, only the U.S. has shown willingness to fund the program.

But several of the panelists agreed that local and national rules can only do so much. International mechanisms are needed most, and that starts with getting a consensus on what constitutes substandard drugs and what constitutes fraudulent drugs. Attiran recalled the Kyoto Protocol, which demanded that countries reduce carbon emissions by at least 6%; countries that wanted to do more were welcome to. Setting a reasonable floor — and the accompanying unlimited ceiling — would be a start, he said.

“The floor should be high enough that we’re comfortable” using those drugs, Nahlen said.

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