Title: Using IP law as a medical patient safety tool: efforts from the US and China

Authors: Robert Jameson, James Chin, Frank Peo, Luis Gonzales, Daniel Lorence

Addresses: Center for Technology Assessment, University Park, PA 16802, USA. ' Center for Technology Assessment, University Park, PA 16802, USA. ' Center for Technology Assessment, University Park, PA 16802, USA. ' Center for Technology Assessment, University Park, PA 16802, USA. ' Center for Technology Assessment, University Park, PA 16802, USA

Abstract: The unregulated manufacture of prescription drugs, sold under a known generic or brand name, poses an increasing safety risk to unsuspecting healthcare consumers around the world. Those who receive a counterfeit medication may be at risk for a number of dangerous health consequences. Patients may experience unexpected side effects, allergic reactions, or worsening of their medical condition. Many counterfeits do not contain any active ingredient and instead use inert substances which provide no medical treatment benefit. Counterfeit medications may also contain incorrect ingredients, improper dosages of the correct ingredients, or may contain hazardous ingredients. As a collaborative countermeasure model, we summarise here joint anti-counterfeiting efforts through intellectual property rights (IPR) enforcement by the US and China. Such cooperative work serves as a model for enforcement and illustrates how intellectual property (IP) law is being applied across borders to combat unregulated prescription drug manufacture and sale.

Keywords: patient safety; quality; counterfeit medicines; intellectual property; IP law; patents; trade-related aspects of intellectual property rights; TRIPs; World Health Organization; WHO; anti-counterfeiting; USA; United States; China; cooperation; unregulated prescription drugs.

DOI: 10.1504/IJIPM.2009.023262

International Journal of Intellectual Property Management, 2009 Vol.3 No.2, pp.155 - 168

Published online: 15 Feb 2009 *

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