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

WHO Drug Information Vol 18, No. 2, 2004
Safety of Medicines
Combating counterfeit medicines*
Substandard medicines are products whose composition and ingredients do not meet the correct
scientific specifications and which may consequently be ineffective and often dangerous to the
patient. Substandard products may occur as a result of negligence, human error, insufficient human
and financial resources or counterfeiting.
Counterfeit medicines are part of the broader phenomenon of substandard pharmaceuticals. The
difference is that they are deliberately and fraudulently mislabeled with respect to identity and/or
source. Counterfeiting can apply to both branded and generic products and counterfeit medicines
may include products with the correct ingredients but fake packaging, with the wrong ingredients,
without active ingredients or with insufficient active ingredients. In wealthier countries, new expensive
medicines are frequently counterfeited such as hormones, corticosteroids, cancer drugs or
antiretrovirals. In developing countries, the most counterfeited medicines are those used to treat
life-threatening conditions such as malaria, tuberculosis and HIV/AIDS.
Trade in these medicines is more prevalent in countries with weak drug regulation control and
enforcement, scarcity and/or erratic supply of basic medicines, unregulated markets and
unaffordable prices (http://www.who.int/medicines). It is estimated that counterfeits make up a
significant proportion of the global medicines market and are present in both industrialized and
developing countries. Industry figures estimate annual earnings from the sales of counterfeit and
substandard medicines at over US$ 32 billion globally.
International action against
counterfeiting
A workshop on counterfeit medicines, was held
from 13 to 14 February 2004 in Madrid, Spain on
the occasion of the International Conference of
Drug Regulatory Authorities (ICDRA).
The workshop was attended by national drug
regulatory authorities, international organizations,
nongovernmental organizations, industry associations,
and the media. The programme included
presentations on national experience, investigation
and action against counterfeits, control of ecommerce
counterfeiting, and perspectives from
regulatory authorities and international organizations.
A draft concept paper on a framework
convention against counterfeiting was debated
and recommendations proposed. A summary of
* Views expressed during meeting reports do not
necessarily reflect WHO position, policy or endorsement.
highlights is set out on the following pages and a
full report of the event is available at http://
www.who.int/medicines
Industry response to counterfeiting
The view of a leading multinational pharmaceutical
company was presented. It is generally
agreed that counterfeit drugs endanger health,
threaten the reputation of drug companies and
undermine regulatory action to control counterfeiting.
The presence of counterfeits can also cause
a loss of trust in the public health system by
patients. Strong internal company strategies to
combat counterfeiting are therefore a responsive
solution. These may include formal investigative
procedures, anti-counterfeiting features in
packaging, maintaining secure manufacturing and
supply sources, and conduct of market surveys.
External strategies may include consumer
education, tougher laws, strengthened enforcement
and stricter penalties. Both covert and overt
measures are available to companies to combat
counterfeiting. Measures taken should be difficult
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