I. Background and Problem Description
A. Counterfeit Medicines
A counterfeit medicine is defined by the World Health Organisation (WHO) as "a medicine, which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. (1)"
Counterfeiting of branded, generic and over the counter products occurs in all therapeutic categories and can mimic everything from weight loss supplements to medications for erectile dysfunction, cancer, HIV/AIDS, diabetes, and malaria (2,3).
B. On the Global Agenda
Although counterfeit products have long infiltrated global pharmaceutical markets (4), the growth of and danger from counterfeit medicines has become more prominent on the global agenda in recent years, due to a significant increase the manufacture, trade and distribution of these products (3). The ‘frenetic pace of globalisation’ and increasingly defenceless international borders (5) have enabled contributory factors including:
Globalization of free trade
Inequitable access to or scarcity of essential medicines
Lack of appropriate legislation and enforcement of existing regulations
Inefficient supply chains
C. Public Health Threat
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...d 2014 Mar 27]. Available from: http://www.scidev.net/global/health/spotlight/detecting-counterfeit-drugs.html
10. Eye on the Ball: Medicine Regulation - not IP enforcement - can best deliver quality medicines. 2011 p. 1–51.
11. Lee K, Drager N. The World Trade Organization and public health. Global Change and Health. Maidenhead: Open University Press; 2005. p. 83–95.
12. Sheridan C. Bad medicine. Nat Biotechnol. 2007 Jul;25(7):707–9.
13. Making a killing: the deadly implications of the counterfeit drug trade. Washington, D.C.; 2008 p. 1–116.
14. Frenk J, Moon S. Governance Challenges in Global Health. N Engl J Med. 2013;368(10):936–42.
15. Dal B, Sunderland L, Drager N. Forging the Trade Link in Global Health Governance. In: Cooper AF, Kirton JJ, editors. Innovation in Global Health Governance. Surrey: Ashgate Publshing Group; 2009. p. 245–67.
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