Patents Play A Role in Drug Importation Debate

Many contend that American consumers would pay less for medicines if the U.S. market were opened to imported drugs. Indeed, the Medicine Equity and Drug Safety Act of 2000 purported to open the U.S. market to drug importation from 25 countries if the secretary of Health and Human Services certified that there would be no risk to public health or safety and that there would be a significant cost reduction. While the secretary has provided no such certification, the Food and Drug Administration (FDA) has adopted a policy of not enforcing, against individuals, the standing law that only FDA-approved manufacturers may import drugs. As a result, cross-border sales of pharmaceuticals have now risen to well above $1 billion annually.

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