Government

Drug reimportation situation is shifting as Canada could cut availability

Demand, congressional attention and a Canadian government proposal could mean suppliers increasingly move to overseas sources.

By Joel B. Finkelstein — Posted Jan. 24, 2005

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Washington -- Some federal lawmakers are pushing hard to allow Americans to readily buy prescription drugs from other countries, but passing such legislation could be the death knell for current trends in reimportation.

As more and more U.S. residents shop across the border for pharmaceuticals -- one estimate put total sales at close to $700 million from Canada alone in 2003 -- a political war has been raging between lawmakers who say Americans should be able to do so legally and those who say it isn't worth the risk.

That debate will be front and center in Congress this year as reimportation legislation that failed to move last year is reintroduced. Senate Democrats are expected to push hard for passage of measures that could require the Food and Drug Administration to implement a protocol and procedures for imported drugs, experts said.

Sen. Byron Dorgan (D, N.D.), is expected to introduce a reimportation bill sometime in February and, it is rumored, might place a hold on the confirmation of Mike Leavitt as head of the Dept. of Health and Human Services to ensure that the measure gets a floor vote.

While Dorgan's office would not confirm that, a spokesman said holding up a confirmation is one tool the senator could use to ensure that the bill gets a chance, but there is no reason to think he would limit himself to just one method.

The AMA opposes personal drug importation but has said it would support reimportation by pharmacies and wholesalers if its safety concerns are met.

If legislation passes this year, it could do the reimportation market more harm than good, experts said. "It's quite different when 1,000 people go up, versus saying 200 million people want their drugs from Canada. That puts pressure on the system," said Bryan A. Liang, MD, PhD, director of the Institute of Health Law Studies at California Western School of Law and the University of California, San Diego School of Medicine.

At the current level, reimportation is sustainable, said David Robertson, president of Total Care Pharmacies, which owns one of the largest Canadian-based online retailers serving Americans, crossborderpharmacy.com.

"From the U.S. point of view, this is a very small business," he said. "The Canadian government ... is worried that this could become standard practice in the U.S. If that was to happen, then we would not have the drug supply."

That prospect has helped convince Canadian leaders that the issue needs to be addressed before the U.S. Congress acts.

"The attitude in the past has been, if it isn't hurting Canadians and you're following the rules, then we're going to do nothing," Robertson said.

But Canadian officials recently said they are taking steps to stop the medication supply in that country from being diverted to the United States. An administrative regulation change would require that Canadian physicians see American patients face-to-face to prescribe a drug. Currently, the doctors copy prescriptions written by their U.S. counterparts.

The old mind-set has changed since the drug industry has stepped into Canadian politics, Robertson said.

The industry always has had representatives in Canada, and reimportation is just one concern that they discuss with government officials, said Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America.

If, as industry experts expect, the Canadian rule change is implemented sometime in February, then U.S. residents now ordering drugs from Canadian pharmacies might have to start looking elsewhere for their bargains.

"Today, Canada is still the most sought-after country because Americans still feel very comfortable dealing in Canada. If the door is shut, then they really are not going to have much choice but to look at our overseas options," Robertson said.

About 80% of customers still choose to get their drugs from Canadian sources when given the option to get medication from other countries, he said.

Moving overseas

Robertson said there is a legitimate concern that the Canadian drug supply cannot continue serving a growing U.S. market forever, which is why online pharmacies such as Total Care and Kohler's have been working to establish sources in other countries for some time now.

Total Care has pharmacists located in places such as the United Kingdom, Israel and Australia following strict safety procedures, Robertson said. Kohler's has set up a facility in the Bahamas through which European and other supplies can be tracked and shipped out to customers.

Those countries are on the FDA's list of recognized overseas locations from which Americans can feel safe buying drugs. Originally, that list was meant only to inform tourists visiting those places but is now being used by pharmacies as a guide.

Markets outside the United States and Canada can be used safely, said Lee Graczyk, legislative director at the Minnesota Senior Federation, which has been assisting its members in purchasing reimported drugs.

"We will have pretty much as good sources as we have now, only they will be coming directly out of the European market," he said. Many of the drugs coming from those countries are produced in FDA-inspected plants and come off the same line as medications imported by the drug manufacturers themselves.

But some experts have significant doubts about the countries that could step in to pick up Canada's slack.

"The Bahamas, but also Pakistan, India, Turkey, China -- all of those countries are going to become big source countries for drugs people want. From that point of view there really is a safety issue involved," Dr. Liang said.

Even groups such as the European Union have a much bigger problem with counterfeit prescription drugs than the United States does because drugs can pass across multiple borders, he said. This makes it difficult to track their pedigrees.

Americans could end up getting tainted, bogus or impotent medications without even knowing it, Dr. Liang said.

"It is so hard to detect fake drugs and harmful drugs, because response to the therapy can be attributed to human variation. You can't ever tell. It's the perfect crime. A drug is used, the bottle is thrown away, the stuff is metabolized," he said.

Unless a physician or someone else decides to test the patient for levels of the drug, no one will ever know the pills were inactive.

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