Abstract

http://ssrn.com/abstract=2259119
 


 



Stemming the Global Trade in Falsified and Substandard Medicines


Lawrence O. Gostin


Georgetown University - Law Center - O'Neill Institute for National and Global Health Law

Gillian J. Buckley


The National Academies - Institute of Medicine (IOM)

Patrick W. Kelley


Independent

April 24, 2013

Journal of the American Medical Association, Vol. 309, pp. 1693-1694, 2013
Georgetown Public Law Research Paper No. 13-033

Abstract:     
Drug safety and quality is an essential assumption of clinical medicine, but there is growing concern that this assumption is not always correct. Poor manufacturing and deliberate fraud occasionally compromises the drug supply in the United States, and the problem is far more common and serious in low- and middle-income countries with weak drug regulatory systems. An Institute of Medicine consensus committee report identified the causes and possible solutions to the problem of falsified and substandard drugs around the world.

The vocabulary people use to discuss the problem is itself a concern. The word counterfeit is often used innocuously to describe any drug that is not what it seems, but some NGOs and emerging manufacturing nations object to this term. These groups see hostility to generic pharmaceuticals in a discussion of counterfeit medicines. These groups see hostility to generic pharmaceuticals in a discussion of counterfeit medicines. Precisely speaking, a counterfeit drug infringes on a registered trademark, and trademark infringement in not necessarily a problem of public health consequence. Instead of talking broadly about counterfeit drugs, the WHO and other stakeholders should consider two main categories of drug quality problems. Falsified medicines misrepresent the product’s identity or source or both. Substandard drugs fail to meet the national specifications given in an accepted pharmacopeia or the manufacturer’s dossier. In practice, there is often considerable overlap between categories.

There is considerable uncertainty about the size of the falsified and substandard drug market. Improved pharmacovigilance, especially in developing countries, give a better picture of the scope of the problem. In the United States, tighter regulatory controls on the wholesale market and a mandatory drug tracking system would improve drug safety. In developing countries, development finance organizations should invest in small- and medium-sized pharmaceutical manufacturers, and governments should use tools such as franchising, accreditation, low-interest loans, and task shifting to encourage private sector investment in drug retail. Finally, the WHO should work with stakeholders such as the UNODC and the WCO to develop an international code of practice on falsified and substandard drugs.

Number of Pages in PDF File: 3

Keywords: drug quality, global trade of medicine, substandard medicines

JEL Classification: K30, K32, K39

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Date posted: May 2, 2013  

Suggested Citation

Gostin, Lawrence O. and Buckley, Gillian J. and Kelley, Patrick W., Stemming the Global Trade in Falsified and Substandard Medicines (April 24, 2013). Journal of the American Medical Association, Vol. 309, pp. 1693-1694, 2013; Georgetown Public Law Research Paper No. 13-033. Available at SSRN: http://ssrn.com/abstract=2259119

Contact Information

Lawrence O. Gostin (Contact Author)
Georgetown University - Law Center - O'Neill Institute for National and Global Health Law ( email )
600 New Jersey Avenue, NW
Washington, DC 20001
United States
202-662-9038 (Phone)
202-662-9055 (Fax)
Gillian J. Buckley
The National Academies - Institute of Medicine (IOM) ( email )
500 Fifth Street, NW
Washington, DC 20001
United States
Patrick W. Kelley
Independent ( email )
No Address Available
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