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Countering the Problem of Falsified and Substandard Drugs (Paperback)
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Countering the Problem of Falsified and Substandard Drugs (Paperback)
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The adulteration and fraudulent manufacture of medicines is an old
problem, vastly aggravated by modern manufacturing and trade. In
the last decade, impotent antimicrobial drugs have compromised the
treatment of many deadly diseases in poor countries. More recently,
negligent production at a Massachusetts compounding pharmacy
sickened hundreds of Americans. While the national drugs regulatory
authority (hereafter, the regulatory authority) is responsible for
the safety of a country's drug supply, no single country can
entirely guarantee this today. The once common use of the term
counterfeit to describe any drug that is not what it claims to be
is at the heart of the argument. In a narrow, legal sense a
counterfeit drug is one that infringes on a registered trademark.
The lay meaning is much broader, including any drug made with
intentional deceit. Some generic drug companies and civil society
groups object to calling bad medicines counterfeit, seeing it as
the deliberate conflation of public health and intellectual
property concerns. Countering the Problem of Falsified and
Substandard Drugs accepts the narrow meaning of counterfeit, and,
because the nuances of trademark infringement must be dealt with by
courts, case by case, the report does not discuss the problem of
counterfeit medicines.
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