December 1st, 2006 11:19 EST
Tougher trademark laws considered, say Justice officials
Washington -- The United States government is expanding its efforts to combat the rising threat posed by dangerous counterfeit drugs entering global markets, say U.S. Department of Justice officials.
More than 10 percent of the drugs sold around the world today are counterfeit, according to the World Health Organization, and the problem is growing.
“We view it as serious business,” Eugene Thirolf told an audience in Taiwan via digital videoconference November 28. Thirolf is director of the U.S. Department of Justice office that assists the Food and Drug Administration (FDA) in prosecuting counterfeiters.
The removal of counterfeit drugs from the marketplace is “critical,” he said.
“Maintaining the confidence of the American public or the public in Taiwan that the products that they are taking are, in fact, going to help them, and are safe and effective --it is something that must be maintained,” Thirolf said.
“The drug supply in the United States remains safe, but we believe [there are] increasingly sophisticated and challenging threats from those who want to take advantage of the American market,” Thirolf said. “Organizations and individuals who peddle these fake medicines put unsuspecting patients at risk -- not only in the United States, but around the world.”
Counterfeit drugs often look like the authentic product, but might not contain any of the active (therapeutic) ingredients, might contain too much of the active ingredients, might contain too little of the active ingredients, or might contain contaminants that are potentially dangerous to the consumer’s health.
Although all counterfeit products are violations of someone’s intellectual property rights (IPR), John Zacharia, an IPR attorney with the Department of Justice, told the conference participants that most counterfeit drug cases are prosecuted under the Federal Food, Drug and Cosmetic Act rather than as trademark violations.
“Unlike, for example, counterfeit luxury items … where the actual Gucci brand or Nike brand matters,” Zacharia explained, “with counterfeit drugs, most of the time, the purchasers don't care if the [trade]mark is on it, they just want the drug. So the counterfeiters know this, and so they on purpose don't usually use the mark.”
If counterfeiters are caught, penalties are milder under the Cosmetic Act. The maximum criminal penalty under trademark law is 10 years in prison compared with three years under the cosmetic law.
In March, however, the U.S. Congress changed trademark law “to make it a little easier to show trafficking” in counterfeit drugs, he continued. This modification “broadens the scope of what we can prosecute,” making the statute easier to apply, Zacharia said. (See related article.)
Both officials mentioned that there are proposals before the U.S. Congress to modify the criminal statute on trademarks in order to make penalty for cases of counterfeit pharmaceutical trademarks more severe -- higher than the current 10 year maximum for trademark infringements in general.
In addition, a new FDA regulation that went into effect in November requires companies that sell drugs in the United States to show proof of where the drug was manufactured.
“It is called a ‘pedigree,’” Thirolf said. “It would be like showing that you have evidence that you have a drug that came from the manufacturer.”
See also "Public Safety Jeopardized by Chinese Counterfeiters, Experts Say."
For more information on U.S. policy, see Protecting Intellectual Property Rights.
More information on counterfeit drugs is available on the U.S. Department of Justice, Food and Drug Administration and World Health Organization Web sites.
(USINFO is produced by the Bureau of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)