WHO Drug Information Vol. 18, No. 2, 2004 - World Health ...

Safety of Medicines
to copy, combinatorial, easy to incorporate, and
not require regulatory approval and may include
user education or deterrents to counterfeiting.
The Pharmaceutical Security Institute (PSI)
represents a group of multinational pharmaceutical
companies . Its role is to combat counterfeiting
through collection, collation and dissemination of
information and to identify and satisfy training
needs. Drug investigations by law enforcement
agencies are often under-resourced due to other
crime priorities. PSI key findings in 2003 concluded
that of 327 reported incidents of crime in
pharmaceuticals, 81% involved counterfeits. Most
incidents occurred in the USA, followed by India
and China. A key trend indicates that counterfeiting
operations are small. In all, 363 people were
arrested with an average value of seizure at US$
3 million. Fifty-three percent of arrests were made
at the point of sale; 13% were manufacturers and
5% were at borders. The US market is predicted
to become an attractive target for counterfeit
medicines and drug diversion. International mail is
highlighted as a distribution corridor readily
exploited by medicine traffickers.
A presentation from the self medication industry
provided statistical information in relation to the
prevalence of counterfeits in Latin America and
globally. It confirmed that counterfeit drugs pose a
significant public health risk and stated that
counterfeiting involves established, sophisticated,
regional criminal organizations and international
organized crime. Factors that make counterfeiting
a widespread activity are:
• Lack of access to many drugs, making lowpriced
counterfeit products attractive.
• Possibility of selling counterfeit drugs from
varied outlets.
• Sale of products without a physician’s prescription
facilitates the selling of fake or counterfeit
products
• Outside of pharmacies, vendors do not posses
the same ability to detect counterfeit products
as pharmacists do.
• Counterfeiting is not a specific crime and
inadequate penalties are applied to drug
counterfeiting.
• Lack of intellectual property protection.
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WHO Drug Information Vol 18, No. 2, 2004
• Existence of free trade zones.
• Internet sales leading to cross-border trade in
counterfeits.
Factors that are successful in combating counterfeiting
are:
• Interagency cooperation.
• Categorizing counterfeiting as a specific crime.
• Establishment of stiffer penalties.
• Monitoring of wholesalers and pharmacies.
• The development of best practice manuals on
distribution and dispensing of medicines.
• Consumer education.
In conclusion, essential benefits could be gained
from collaboration between the pharmaceutical
industry and regulators through development of a
comprehensive plan.
E-commerce and challenges
to pharmaceutical trading
Sale of drugs on the Internet has both positive
and negative aspects. Prescription drug sales on
the Internet can provide benefits to consumers,
especially to the disabled or homebound patients
who cannot move easily. It is convenient for
shopping 24 hours a day and gives privacy and
anonymity to those who do not want to discuss
their medical condition in a public place. However,
the negative aspects include possible sale of
unapproved new drugs, absence of doctor/patient
relationship and possibility of obtaining information
on correct use, dispensing of prescription
drugs without prescription, and availability of
products with fraudulent claims.
The United States Food and Drug Administration
has taken steps to customize and expand its
enforcement efforts by setting priorities, improving
data acquisition, and coordinating case assessment.
This has resulted in the evaluation of over
400 websites and an increased number of civil
and criminal actions, improved collaboration with
international regulatory officials and the issuance
of cyber letters. Hard copies of each cyber letter
are sent to the website operator, the US Customs
Service and the regulatory authority officials in the
country in which the operator is based. Other