On Dec. 25, 2014, the Russian Parliament adopted new legislation
aimed at the criminalization of (1) pharmaceutical counterfeiting
and (2) distribution of counterfeited and falsified medicines and
medical devices. The law became effective on Jan. 23, 2015.
Several articles of the Russian Criminal Code were amended to
include the following new provisions:
Under article 235 of the Russian Criminal Code, the penalty for
unauthorized manufacturing of medicines and medical devices (for
which authorization is required) is 3-5 years imprisonment and a
fine in the amount of 500,000 to 2,000,000 rubles (at today's
exchange rates, that equals about USD $8,000-$31,000). If the crime
was committed by a criminal organization or on a large scale
(exceeding 100,000 rubles or USD $1,500), the penalty is 5-8 years
imprisonment and a fine in the amount of 1,000,000 to 3,000,000
rubles (approximately USD $15,500-$46,000).
Under article 238 of the Criminal Code, the penalty for the
circulation of falsified, defective, unregistered medicines,
medical devices and circulation of falsified biologically active
supplements is 3-5 years of compulsory labour, deprivation of the
right to hold certain positions or carry out certain activities for
up to 3 years, or 3-5 years imprisonment and a fine in the amount
of 500,000 to 2,000,000 rubles (approximately USD $8,000-$31,000).
If the crime was committed by a criminal organization or the crime
committed caused grievous bodily harm or death, the penalty will be
5-8 years imprisonment and a fine in the amount of 1,000,000 to
3,000,000 rubles (approximately USD $15,500-$46,000).
Under article 6.33 of the Russian Administrative Code, the
circulation of falsified, counterfeit, defective and unregistered
medicines, medical devices and circulation of falsified
biologically active supplements will lead to an administrative fine
in the amount from 1,000,000 to 5,000,000 rubles (approximately USD
$15,00-$77,000) or suspension of activities for a term of 90 days.
Circulation is defined as:
sale or import of falsified medicines in Russia;
sale or import of falsified medical devices in Russia;
sale or import
into Russia of counterfeit medicines;
sale or import
into Russia of counterfeit medical devices or;
falsified biologically active supplements.
Under article 327 of the Criminal Code, forgery of documents
for medicines and medical devices or packages of medicines or
medical devices will lead to a fine in the amount of 500,000 to
1,000,000 rubles (or approximately USD $8,000-$16,000).
Prior to the enactment of this new law, the trading in
counterfeit drug products was treated no differently than for
luxury goods, where the sanctions are primarily seizure of the
offending goods and a trivial fine. The much harsher sanctions
under the new law reflect the serious public health concerns
associated with the distribution of fake and potentially dangerous
drugs to innocent consumers.
Contributions to this article were also made by Meldir
Erbulekova, Student-at-Law at the Gowlings Moscow office.
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