Abstract. Importation of medicines from Canada and other countries has been proposed to provide relief from high drug prices in the US and greater access for underserved patients. Yet importation necessarily raises the issue of counterfeit drugs. The latter are a worldwide problem that have affected even the US closed regulatory and supply system. Counterfeit drugs were previously limited to lifestyle drugs; yet they now encompass virtually all types of medicines and extend to lifesaving drugs. Organized crime and terrorist groups are increasingly involved in their production. The expansion of counterfeit drug manufacture is due to their ease of production and this activity's tremendous financial rewards, coupled with limited potential for being caught, and light penalties even if prosecuted. Further, the gray market in the US, and parallel trade in others, make it simple to introduce fake drugs into the medicine supply. Detection of counterfeit medicine is virtually impossible, with provider low index of suspicion, high quality packaging and product, and ignorance regarding sources of imported drugs, including the Internet. The major importation bill being considered in Congress has significant weaknesses in addressing many of these crucial issues and may expand this country's vulnerabilities that arise from its domestic gray market to that of the international black market. To fully address the international issues associated with importation and counterfeit drugs, an international solution must be engaged. Cooperation and empowerment of law enforcement and regulators, public and private agencies, and entities across country lines are essential. Sharing the cost of research and development based on WTO and OECD wage standards should also be considered. Finally, providers must have a high index of suspicion when confronted with therapeutic medication failure, public-private partnerships should be expanded to provide safe and affordable domestic drugs now, and patients must be educated to be the last barrier to harm from counterfeit drugs. Only by adopting a systemic effort can we address the systemic problems associated with importation and counterfeit drugs.
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