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 video
conference 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 may not contain any of the active (therapeutic)
ingredients; contain too much of the active ingredients;
contain too little of the active ingredients; or may 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.
Nadine Siak
USINFO Staff Writer
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