The problem of counterfeit drugs has made headlines in recent years with, for example, the discovery of fake versions of the cancer drug Avastin showing up in US hospitals. But the problem is worst in developing countries, where up to 25% of drugs in developing countries are falsified or substandard, according to the World Health organization (WHO).
Some global health advocates say that international players such as the WHO have not outlined sufficiently effective plans to deal with the problem of counterfeit drugs. In an essay published online today in PLOS Medicine, health policy specialists, including the Rwandan Minister of Health, Agnes Binagwaho, review data from 17 countries and suggest that Rwanda, a country once engulfed in conflict, serves as an example of how a committed approach can safeguard drug supplies.
The essay highlights the safety of Rwanda’s tuberculosis drugs, as reported in a March 2013 study published in The International Journal of Tuberculosis and Lung Disease. In that earlier study, researchers posing as local customers visited 19 cities to obtain 713 samples of tuberculosis treatment medications. No active ingredient was found in almost 10% of all the samples. The proportion of counterfeit drugs rose to 17% among medications taken from the 11 African nations in the study. However, no falsified medications came from Rwanda.
The East African nation’s success is founded on the government’s integrated approach, linking health and enforcement agencies to regulatory control, says Amir Attaran, a senior author on the new essay and a health law expert at the University of Ottawa. Some of the stringent steps the Rwandan government takes include giving drug contracts only to manufacturers with current WHO-approved certificates of good manufacturing practices, mandatory inspections of incoming drug shipments and routine sampling of medications. The country’s Ministry of Health drafted guidelines in 2011 detailing measures to ensure drug quality, such as setting up agency outposts at 469 health centers to the rollout of patient forms for reporting adverse drug events. Rwanda also banned the majority of private pharmacies in the nation from selling tuberculosis drugs, making it easier to control the drug supply chain.
Not all experts are convinced that Rwanda can be held as an example of success, however. The tight control exercised by the Rwandan government over regulatory drug policy may have affected the researchers’ free access to drug samples—and subsequent study results, says Patrick Lukulay, director of the Promoting the Quality of Medicines Program within the US Pharmacopeial Convention (USP), a Rockville, Maryland nonprofit.
But Roger Bate, an economist with the American Enterprise Institute in Washington, DC, and author on both the new essay and the March 2013 counterfeit drug study, counters that although Rwanda is eager to showcase their success, he has “no reason to believe the sample is biased.”
Even if Rwanda has secured a safe supply of drugs, Lukulay says the only way to attack the problem is for regional blocs to act together. “You may have one country doing a good job, but if the neighboring country is in disarray then the borders are still porous.” Several international efforts have been launched to “put hands around this issue,” he says, including the East African Community Medicines Registration Harmonization Project, in which Rwanda is a partner
“It’s not a one-size-fits-all plan,” agrees Attaran, regarding Rwanda’s efforts. What will help everyone is a treaty, because it could provide an international shared view, he says. “When countries decide to focus on a problem, they will solve it.”