Congress OKs drug reimportation from Canada with safety caveat

The measure included with Medicare reform is unlikely to lead to legalization, but proponents aren't ready to give up.

By Joel B. Finkelstein, AMNews staff. Dec. 15, 2003.

Washington -- The Medicare reform bill recently adopted by Congress contains prescription drug reimportation language that is expected to suffer the fate of prior measures that were passed but not implemented.

The Dept. of Health and Human Services has opposed the legalization of reimportation on the grounds that it cannot be done without increasing the risk of counterfeit and tainted prescriptions drugs coming into the country. Because the agency, under both Presidents Clinton and Bush, has maintained that it cannot guarantee the safety of reimported American-made drugs, such laws have never been put into effect.

The final Medicare reform agreement, which allows imports from Canada only, requires that the department certify the safety of reimportation, again all but assuring that the practice will remain illegal.

The decision to give HHS veto power over reimportation has spurred proponents to turn attention back to stand-alone legislation sponsored by Rep. Gil Gutknecht (R, Minn.). His bill would allow reimportation from Food and Drug Administration-approved facilities in 25 industrialized countries and would require the use of technology to prevent counterfeiting.

"All this means is that Americans will have to wait a little longer," Gutknecht said. "Sooner or later, Washington officials will be forced to lead, follow or get out of the way."

On the other side of the debate, drug makers argue that reimportation poses a safety issue. "Those who choose to ignore it do so at their own risk," said Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America. The United States already has a small domestic counterfeit problem, but it cannot compare to the scale of international counterfeiting rings that would gain a foothold if borders were opened by reimportation, he said.