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Stemming the Global Trade in Falsified and Substandard Medicines

Stemming the Global Trade in Falsified and Substandard Medicines VIEWPOINT ONLINE FIRST Stemming the Global Trade in Falsified and Substandard Medicines products are only those that infringe on a registered trade- Lawrence O. Gostin, JD mark. Stakeholders concerned with access to generic medi- Gillian J. Buckley, MPH, PhD cines fear that action against counterfeit drugs would mean Patrick W. Kelley, MD, DrPH stricter enforcement of intellectual property rights, thereby reducing the availability of inexpensive generics. HEN HIPPOCRATES ADVISED PHYSICIANS TO To avoid confusion, the term counterfeit should be used never give a deadly drug, he assumed they only to describe a trademark infringement. Medicines pos- would know for sure that the medicines ing a public health concern include 2 overlapping catego- Wthey prescribed were safe. Today, criminals ries. A falsified drug misrepresents the product’s identity, and unscrupulous manufacturers have permeated the source, or both. A substandard drug fails to meet national global pharmaceutical market, calling into question this specifications in accepted pharmacopoeia or the manufac- basic assumption of clinical practice. Between November turer’s dossier. This language frames falsified and substan- 2012 and March 2013, an injectable drug compounded dard medicines exclusively as a public health problem. Con- under unhygienic conditions at the New England Com- sistent use of http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Stemming the Global Trade in Falsified and Substandard Medicines

JAMA , Volume 309 (16) – Apr 24, 2013

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Publisher
American Medical Association
Copyright
Copyright 2013 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2013.3048
pmid
23579391
Publisher site
See Article on Publisher Site

Abstract

VIEWPOINT ONLINE FIRST Stemming the Global Trade in Falsified and Substandard Medicines products are only those that infringe on a registered trade- Lawrence O. Gostin, JD mark. Stakeholders concerned with access to generic medi- Gillian J. Buckley, MPH, PhD cines fear that action against counterfeit drugs would mean Patrick W. Kelley, MD, DrPH stricter enforcement of intellectual property rights, thereby reducing the availability of inexpensive generics. HEN HIPPOCRATES ADVISED PHYSICIANS TO To avoid confusion, the term counterfeit should be used never give a deadly drug, he assumed they only to describe a trademark infringement. Medicines pos- would know for sure that the medicines ing a public health concern include 2 overlapping catego- Wthey prescribed were safe. Today, criminals ries. A falsified drug misrepresents the product’s identity, and unscrupulous manufacturers have permeated the source, or both. A substandard drug fails to meet national global pharmaceutical market, calling into question this specifications in accepted pharmacopoeia or the manufac- basic assumption of clinical practice. Between November turer’s dossier. This language frames falsified and substan- 2012 and March 2013, an injectable drug compounded dard medicines exclusively as a public health problem. Con- under unhygienic conditions at the New England Com- sistent use of

Journal

JAMAAmerican Medical Association

Published: Apr 24, 2013

References