Summary

Counterfeit and substandard medicines are an insidious threat to the United States and to global health more broadly, and the risks they pose have been largely underestimated to date. Counterfeits containing no active ingredient will fail to cure disease; those with wrong ingredients may cause mental and physical damage--and even death. Counterfeits containing insufficient active ingredients breed resistance, which can make authentic drugs useless. No area of the world is unaffected, as exposed by the recent deaths in the United States from tainted heparin. Mounting evidence shows that the problem is disproportionately severe in developing and emerging-market countries, which also have the highest burden of infectious diseases. National governments have the primary responsibility--both in stopping criminal manufacturing and distribution and in protecting their citizens from counterfeit products. The Food & Drug Administration (FDA) is highly active in fulfilling this responsibility, but this is not true in many other countries in the world. Multilateral organizations such as the World Health Organization (WHO), the World Customs Organization (WCO), and the International Criminal Police Organization (Interpol) must do more to expose the problem and help countries tighten regulatory controls. Companies affected by counterfeiting in developing countries are expending private resources to perform roles which should be carried out by police and regulators, including assisting multilateral organizations in building capacity among local customs and regulatory officials.

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Roger Bate is a resident fellow at AEI. Richard Tren is the director of Africa Fighting Malaria.