Report: Europe's Drug Importation System Safe

Study Issued by AARP Intensifies Debate Over Allowing Foreign Prescription Drugs Into U.S.

From the WebMD Archives

June 22, 2005 -- Supporters of allowing lower-cost foreign prescription drugs into the U.S. are pointing to Europe as proof that importation can be legalized without compromising the safety of the medication supply.

A report issued Wednesday by AARP states that widespread trade of prescription drugs for more than a decade in Europe has resulted in few of the safety problems predicted by pharmaceutical manufacturers and the Bush administration, which are both strongly opposed to allowing the practice.

"The European experience shows that commercial importation from countries with strong drug regulatory systems can take place without apparent adverse consequences to consumers," concludes the report, authored by Panos Kanavos, a researcher at the London School of Economics.

Congress has passed several laws in recent years allowing consumers and pharmacies to import prescription drugs. But the laws have never gone into effect because of provisions forcing federal officials to first certify that importation poses no health risks.

Drug importation enjoys widespread support, with recent polls showing backing from more than 75% of the public.

Debate Over Safety

Bush administration officials have repeatedly warned that importation would leave consumers vulnerable to counterfeits or drugs that are improperly manufactured, stored, or packaged. FDA officials told Congress last winter that added security measures needed to adequately police legalized imports would cost hundreds of millions of dollars.

Drugmakers remain staunchly opposed to allowing cheaper imports. A web site launched this week by the drug industry's main lobbying group warns that letting prescription drugs cross the border will make American consumers vulnerable to terrorist attacks.

"Importing prescription drugs outside of the FDA delivery system puts patients at risk," Billy Tauzin, a former congressman who is now CEO of the Pharmaceutical Research and Manufacturers of America, said in a statement Tuesday.

The European Experience

The AARP report concludes that no documented cases of counterfeit drug supplies have been found in the European Union, which allows member countries to trade prescription drugs between commercial entities.

But it also concludes that the European countries have had some problems with medications that were improperly labeled or contained inaccurate or incomplete patient information. Such problems led to 50 drug recalls out of approximately 40,000 drug products for sale in Germany between January 2002 and August 2003.

Europe's importation scheme lowered consumer drug prices 12% to 19%, says Mattias Ganslandt, PhD, an economist with the Research Institute of Industrial Economics in Sweden. Savings would likely be higher in the U.S. because it lacks price controls that already lower drug costs in Europe.

But Ganslandt also warned that European law does not allow individuals to buy imported drugs on their own, as supporters in the U.S. favor.

Later, an outspoken pharmaceutical company executive said his industry is making a "historic mistake" in its staunch opposition to legalizing the importation of lower-cost foreign prescription drugs into the U.S.

Peter Rost, a vice president for marketing at the drugmaker Pfizer, last year became a critic of his industry over its opposition to importation. He says that high U.S. prescription prices are keeping lifesaving drugs from "millions" of patients who need them.

Rost stresses that his statements reflect his views and not those of his employer. "I'd like to tell the CEOs of the drug industry, 'Gentlemen, the train has left the station. Please join us,'" he says.

Importation Debate Approaching

Backers of importation in Congress have begun signaling that they are preparing to push new legislation soon. Supporters are looking aggressively for chances to force a vote on a bill that sets up regulations to monitor legalized importation from Canada and more than 20 other countries, says William Pewen, an aide to Sen. Olympia Snowe (R-Maine).

Supporters of the bill, sponsored by Snowe and Sen. Byron Dorgan (D-N.D.), have said they have the 60 votes needed to force Senate action on the measure.

Last month, a bipartisan group of House members signed a letter asking Speaker Dennis J. Hastert (R-Ill.) to schedule a vote on importation legislation. The letter was signed by 221 members, three more than the number needed to force House leaders to allow a vote.

Show Sources

SOURCES: Parallel Trading in Medicines: Europe's Experience and Its Implication for Commercial Drug Importation in the United States, June 22, 2005, AARP. Mattias Ganslandt, PhD, economist, Research Institute of Industrial Economics, Sweden. Billy Tauzin, CEO, Pharmaceutical Research and Manufacturers of America. Peter Rost, vice president for marketing, Pfizer. William Pewen, aide to Sen. Olympia Snowe (R-Maine.).
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