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Volumn 40, Issue 2, 2012, Pages 326-347

Combating Counterfeit Medicines and Illicit Trade in Tobacco Products: Minefields in Global Health Governance

Author keywords

[No Author keywords available]

Indexed keywords

COUNTERFEIT DRUG; DRUG;

EID: 84864003395     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2012.00667.x     Document Type: Article
Times cited : (13)

References (121)
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    • M. Mulumba, quot;Anti-Counterfeiting Legislation in East Africa: A New Assault Against TRIPS Flexibilities for Access to Medicine?"Equinet Newsletter 111 (May 1, 2010), available at <> (last visited March 28, 2012); see Outterson, supra note 105, at 120-121
    • (2012) , pp. 120-121
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    • 84872617818 scopus 로고    scopus 로고
    • The Anti-Counterfeit Bill, 2008 (Kenya)
    • The Anti-Counterfeit Bill, 2008 (Kenya).
  • 58
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    • The Counterfeit Goods Bill (Uganda)
    • The Counterfeit Goods Bill, 2009 (Uganda).
    • (2009)
  • 59
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    • (2010)
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    • "EU Implicated in Controversial Counterfeiting Bill,"
    • See also, M. Wambi, quot;US Intensifies Anti-counterfeit Drive in East Africa,"IPS News (July 19, 2010), available at <> (last visited March 28, 2012);.I. Agazzi, quot;East African Laws Confuse Fake and Generic Drugs - WHO,"IPS Africa (July 19, 2010), available at <> (last visited March 28, 2012); Medicins Sans Frontieres, quot;Ten Stories That Mattered in Access to Medicines in 2010,"available at <> (last visited March 28, 2012)
    • A. Mullard, "EU Implicated in Controversial Counterfeiting Bill, " The Lancet 375, no. 9723 (2010): 1335. See also, M. Wambi, "US Intensifies Anti-counterfeit Drive in East Africa, "IPS News (July 19, 2010), available at <> (last visited March 28, 2012);.I. Agazzi, "East African Laws Confuse Fake and Generic Drugs - WHO, "IPS Africa (July 19, 2010), available at <> (last visited March 28, 2012); Medicins Sans Frontieres, "Ten Stories That Mattered in Access to Medicines in 2010, "available at <> (last visited March 28, 2012).
    • (2010) The Lancet , vol.375 , pp. 1335
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    • (2012)
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    • "The Global IP Upward Ratchet, Anti-Counterfeiting and Piracy Enforcement Efforts: The State of Play,"
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    • Sell, S.1
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    • "Enforcement, Economics and Estimates, "WIPO Journal 2, no. 1 , at 2-6
    • Id., at 12; see also P. Yu, "Enforcement, Economics and Estimates, "WIPO Journal 2, no. 1 (2010): 1-19, at 2-6
    • (2010) , pp. 1-19
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    • Kumar, S.1
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    • See Sell, supra note 141, at 17
    • See Sell, supra note 141, at 17.
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    • See TRIPS Agreement, supra note 23, at preamble.
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    • (2010)
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    • World Customs Organization, Enforcement and Compliance - Responsibilities: The WCO and the Protection of Intellectual Property Rights (IPR), available at <> (last visited April 3(hereinafter cited as WCO Enforcement and Compliance).
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    • (2012)
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    • See WCO Enforcement and Compliance, supra note 158
    • See WCO Enforcement and Compliance, supra note 158.
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    • The International Criminal Police Organization (INTERPOL), "Intellectual Property Rights (IPR) Programme, " available at <> (last visited July 8, 2011).
    • (2011)
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    • United Nations Commission on Crime Prevention and Criminal Justice, quot;Mandate and Functions," available at <> (last visited March 28
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    • United Nations Commission on Crime Prevention and Criminal Justice, Report on the Twentieth Session (December 3, 2010 and April 1115, 2011).
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  • 74
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    • United Nations Convention Against Transnational Organized Crime, U.N.T.S. vol. 2225, No. 39574
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    • Id., at operative para. 1
    • Id., at operative para. 1.
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    • Id., at operative para. 2
    • Id., at operative para. 2.
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    • Id., at operative para. 3
    • Id., at operative para. 3.
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    • Id., at operative para. 4
    • Id., at operative para. 4.
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    • Id., at operative para. 8
    • Id., at operative para. 8.
  • 81
    • 84864024703 scopus 로고    scopus 로고
    • Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Health (to open for signature on October 28 (hereinafter cited as MEDICRIME Convention)
    • Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Health (to open for signature on October 28, 2011) (hereinafter cited as MEDICRIME Convention).
    • (2011)
  • 82
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    • Council of Europe, Medicrime: Introduction, available at <> (last visited March 28 The Convention is the first "binding international instrument in the criminal law field on counterfeiting of medical products and similar crimes involving threats to public health."
    • Council of Europe, Medicrime: Introduction, available at <> (last visited March 28, 2012). The Convention is the first "binding international instrument in the criminal law field on counterfeiting of medical products and similar crimes involving threats to public health.".
    • (2012)
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    • See MEDICRIME Convention, supra note 180, at Article 4j
    • See MEDICRIME Convention, supra note 180, at Article 4j.
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    • Council of Europe Communications, Counterfeit Medical Products: Twelve Countries Join the Council of Europe Medicrime Convention, available at <> (last visited March 28, 2012).
    • Council of Europe Communications, Counterfeit Medical Products: Twelve Countries Join the Council of Europe Medicrime Convention, October 28, 2011, available at <> (last visited March 28, 2012).
    • (2011)
  • 85
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    • See World Health Organization, Reforms for a Healthy Future, supra note 2, at para. 20
    • See World Health Organization, Reforms for a Healthy Future, supra note 2, at para. 20.
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    • quot;How to Set Priorities for the World Health Organization," Global Health Programme Working Paper No. 6
    • G. Silberschmidt, "How to Set Priorities for the World Health Organization, " Global Health Programme Working Paper No. 6 (2011): at 6.
    • (2011)
    • Silberschmidt, G.1
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    • 84872602950 scopus 로고    scopus 로고
    • World Health Assembly, A/63/A/PSR/6, at 14
    • World Health Assembly, A/63/A/PSR/6, at 14.
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    • See Chan, supra note 85
    • See Chan, supra note 85.
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    • See World Health Organization Executive Board, supra note 99
    • See World Health Organization Executive Board, supra note 99.
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    • See Declaration of Rome, supra note 44, at para. 3
    • See Declaration of Rome, supra note 44, at para. 3.
  • 91
    • 84872609030 scopus 로고    scopus 로고
    • quot;Legal Aspects of Defining 'Counterfeit Medicines': A Discussion Paper," World Health Organization Regional Office South East Asia (): at 1
    • S. Park, "Legal Aspects of Defining 'Counterfeit Medicines': A Discussion Paper, " World Health Organization Regional Office South East Asia (2009): at 1.
    • (2009)
    • Park, S.1
  • 92
    • 48349102509 scopus 로고    scopus 로고
    • Substandard Medicines in Resource-Poor Settings: A Problem That Can No Longer Be Ignored
    • J. M. Caudron et al., "Substandard Medicines in Resource-Poor Settings: A Problem That Can No Longer Be Ignored, "Tropical Medicine and International Health 13, no. 8 (2008): 1062-1072, at 1070.
    • (2008) Tropical Medicine and International Health , vol.13 , pp. 1062-1072
    • Caudron, J.M.1
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    • "Counterfeit Drugs: The Good, the Bad and the Ugly,"
    • at 526-530; see. Park, supra note 209, at 16-19
    • K. Outterson and R. Smith, "Counterfeit Drugs: The Good, the Bad and the Ugly, " Albany Law Journal of Science and Technology 16, no. 3 (2006): 525-543, at 526-530; see. Park, supra note 209, at 16-19.
    • (2006) Albany Law Journal of Science and Technology , vol.16 , Issue.3 , pp. 525-543
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    • supra note 19; N. Boister and B. McGrady, quot;Why and How to Make a Treaty Crime of Medicine Counterfeiting: A Reply to Attaran, Bate and Kendall,"Journal of International Criminal Justice 9,
    • See Liberman et al., supra note 19; N. Boister and B. McGrady, "Why and How to Make a Treaty Crime of Medicine Counterfeiting: A Reply to Attaran, Bate and Kendall, "Journal of International Criminal Justice 9, no. 4 (2011): 947-951, at 949-950.
    • (2011) , pp. 947-951
    • Liberman1
  • 95
    • 84872599444 scopus 로고    scopus 로고
    • World Health Organization Framework Convention on Tobacco Control Convention Secretariat, quot;Parties to the WHO Framework Convention on Tobacco Control,"available at <> (last visited March 28
    • World Health Organization Framework Convention on Tobacco Control Convention Secretariat, "Parties to the WHO Framework Convention on Tobacco Control, "available at <> (last visited March 28, 2012).
    • (2012)
  • 96
    • 84872603723 scopus 로고    scopus 로고
    • Price and tax measures (art. 6); protection from exposure to tobacco smoke (art. 8); regulation of tobacco products contents (art. 9); regulation of tobacco product disclosures (art. 10); packaging and labelling (art. 11); education, communication, training and public awareness (art. 12); tobacco advertising, promotion and sponsorship (art. 13); and demand reduction measures concerning tobacco dependence and cessation (art. 14)
    • Price and tax measures (art. 6); protection from exposure to tobacco smoke (art. 8); regulation of tobacco products contents (art. 9); regulation of tobacco product disclosures (art. 10); packaging and labelling (art. 11); education, communication, training and public awareness (art. 12); tobacco advertising, promotion and sponsorship (art. 13); and demand reduction measures concerning tobacco dependence and cessation (art. 14).
  • 97
    • 84872610143 scopus 로고    scopus 로고
    • Illicit trade in tobacco products (art. 15); sales to and by minors (art. 16); and provision of support for economically viable alternative activities (art. 17)
    • Illicit trade in tobacco products (art. 15); sales to and by minors (art. 16); and provision of support for economically viable alternative activities (art. 17).
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    • 84864025779 scopus 로고    scopus 로고
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties, Elaboration of a Protocol on Illicit Trade in Tobacco Products, 2nd sess., FCTC/COP2(12)
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties, Elaboration of a Protocol on Illicit Trade in Tobacco Products, 2nd sess., FCTC/COP2(12) (July 6, 2007).
    • (2007)
  • 99
    • 84864023077 scopus 로고    scopus 로고
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties, Draft Protocol to Eliminate Illicit Trade in Tobacco Products, 4th sess., FCTC/COP4(11) (November 20
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties, Draft Protocol to Eliminate Illicit Trade in Tobacco Products, 4th sess., FCTC/COP4(11) (November 20, 2010).
    • (2010)
  • 100
    • 84864023076 scopus 로고    scopus 로고
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products, Draft Protocol to Eliminate Illicit Trade in Tobacco Products, FCTC/COP/INB-IT/4/7 () (hereinafter cited as Draft Protocol to Eliminate Illicit Trade in Tobacco Products), art. 3
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products, Draft Protocol to Eliminate Illicit Trade in Tobacco Products, FCTC/COP/INB-IT/4/7 (March 21, 2010) (hereinafter cited as Draft Protocol to Eliminate Illicit Trade in Tobacco Products), art. 3.
    • (2010)
  • 101
    • 84864009960 scopus 로고    scopus 로고
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products, 2nd sess., 4th plen. mtg., FCTC/COP/INB-IT/2/VR/4, October 24 at 97
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products, 2nd sess., 4th plen. mtg., FCTC/COP/INB-IT/2/VR/4, October 24, 2008, at 97.
    • (2008)
  • 102
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    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products, Report of the Chairperson of the Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products to the Fourth Session of the Conference of the Parties, FCTC/COP/4/4, May 14
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products, Report of the Chairperson of the Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products to the Fourth Session of the Conference of the Parties, FCTC/COP/4/4, May 14, 2010.
    • (2010)
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    • See World Health Organization, supra note 20; International Agency for Research in Cancer, supra note 20
    • See World Health Organization, supra note 20; International Agency for Research in Cancer, supra note 20.
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    • Draft Protocol to Eliminate Illicit Trade in Tobacco Products, supra note 222, at art. 12.1(b)(i)
    • Draft Protocol to Eliminate Illicit Trade in Tobacco Products, supra note 222, at art. 12.1(b)(i).
  • 105
    • 84872601708 scopus 로고    scopus 로고
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products, 3rd sess., 4th plen. mtg., FCTC/COP/INB-IT/3/VR/4, June 29, 2009, at 91, 93
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products, 3rd sess., 4th plen. mtg., FCTC/COP/INB-IT/3/VR/4, June 29, 2009, at 91, 93.
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    • See MEDICRIME Convention, supra note 180, at preamble
    • See MEDICRIME Convention, supra note 180, at preamble.
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    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties, Guidelines for Implementation of Article 5.3 of the WHO Framework Convention on Tobacco Control, 2nd sess., FCTC/COP3(7)
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties, Guidelines for Implementation of Article 5.3 of the WHO Framework Convention on Tobacco Control, 2nd sess., FCTC/COP3(7), November 22, 2008.
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  • 108
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    • World Health Organization, Engaging and Working with the Commercial Private Sector, WHO Policy Framework, at para. 13
    • World Health Organization, Engaging and Working with the Commercial Private Sector, WHO Policy Framework, September 2010, at para. 13.
    • (2010)
  • 109
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    • See generally International Tax and Investment Center, The Illicit Trade in Tobacco Products and How to Tackle It, available at <> (last visited March 28, 2012).
    • See generally International Tax and Investment Center, The Illicit Trade in Tobacco Products and How to Tackle It, 2010, available at <> (last visited March 28, 2012).
    • (2010)
  • 110
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    • "Commentary on Joossens (2010): 'Eliminating the Global Illicit Cigarette Trade - What Do We Really Know?"
    • E. Blecher, "Commentary on Joossens et al. (2010): 'Eliminating the Global Illicit Cigarette Trade - What Do We Really Know?" Addiction 105, no. 9 (2010): 1650-1651.
    • (2010) Addiction , vol.105 , Issue.3 , pp. 1650-1651
    • Blecher, E.1
  • 111
    • 84872619198 scopus 로고    scopus 로고
    • British American Tobacco, quot;About Illicit Trade," available at <> (last visited March 28
    • British American Tobacco, "About Illicit Trade, " available at <> (last visited March 28, 2012).
    • (2012)
  • 112
    • 84863993653 scopus 로고    scopus 로고
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products, 3rd sess., 1st plen. mtg., FCTC/COP/INB-IT/3/VR/1, June 28 at 11
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products, 3rd sess., 1st plen. mtg., FCTC/COP/INB-IT/3/VR/1, June 28, 2009, at 11.
    • (2009)
  • 113
    • 78650519989 scopus 로고    scopus 로고
    • "The (Un-)systematic Nature of the UN Criminal Justice System: The (Non) Relationship between the Draft Illicit Tobacco Trade Protocol and the UN Convention Against Transnational Organised Crime,"
    • especially at 364-367 and 389-392
    • N. Boister, "The (Un-)systematic Nature of the UN Criminal Justice System: The (Non) Relationship between the Draft Illicit Tobacco Trade Protocol and the UN Convention Against Transnational Organised Crime, " Criminal Law Forum 21, (2010): 361-397, especially at 364-367 and 389-392.
    • (2010) Criminal Law Forum , vol.21 , pp. 361-397
    • Boister, N.1
  • 114
    • 84872602565 scopus 로고    scopus 로고
    • British American Tobacco, quot;How We Tackle Illicit Trade," available at <> (last visited March 28 (emphasis added).
    • British American Tobacco, "How We Tackle Illicit Trade, " available at <> (last visited March 28, 2012) (emphasis added).
    • (2012)
  • 115
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    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties, Establishment of a Permanent Secretariat of the Convention, 1st sess., FCTC/COP1(10), at para. 8
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties, Establishment of a Permanent Secretariat of the Convention, 1st sess., FCTC/COP1(10), February 17, 2006, at para. 8.
    • (2006)
  • 116
    • 84864024711 scopus 로고    scopus 로고
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties, Elaboration of a Protocol on Illicit Trade in Tobacco Products, 2nd sess., FCTC/COP2(12)
    • World Health Organization Framework Convention on Tobacco Control Conference of the Parties, Elaboration of a Protocol on Illicit Trade in Tobacco Products, 2nd sess., FCTC/COP2(12), July 6, 2007.
    • (2007)
  • 117
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    • World Health Organization Framework Convention on Tobacco Control Intergovernmental Negotiating Body on a Draft Protocol on Illicit Trade in Tobacco Products, quot;Informal Working Group on the Draft Protocol to Eliminate Illicit Trade in Tobacco Products: Outcome of the Two Meetings of the Working Group,"5th sess., FCTC/COP/INB-IT/5/3, October 24 at para. 5
    • World Health Organization Framework Convention on Tobacco Control Intergovernmental Negotiating Body on a Draft Protocol on Illicit Trade in Tobacco Products, "Informal Working Group on the Draft Protocol to Eliminate Illicit Trade in Tobacco Products: Outcome of the Two Meetings of the Working Group, "5th sess., FCTC/COP/INB-IT/5/3, October 24, 2011, at para. 5.
    • (2011)
  • 118
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    • Draft Protocol to Eliminate Illicit Trade in Tobacco Products, supra note 222, at art. 36.1
    • Draft Protocol to Eliminate Illicit Trade in Tobacco Products, supra note 222, at art. 36.1.
  • 119
    • 84872594545 scopus 로고    scopus 로고
    • World Health Assembly, A/63/A/PSR/6, at 14
    • World Health Assembly, A/63/A/PSR/6, at 14.
  • 120
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    • World Health Organization Commission on Social Determinants of Health, Closing the Gap in a Generation: Health Equality through Action on the Social Determinants of Health
    • World Health Organization Commission on Social Determinants of Health, Closing the Gap in a Generation: Health Equality through Action on the Social Determinants of Health, 2008.
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    • Report to the fifth session of the Conference of the Parties of the Chairperson of the Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products, FCTC/COP/5/7, May 11, 2012, available at <> (last visited May 21
    • Report to the fifth session of the Conference of the Parties of the Chairperson of the Intergovernmental Negotiating Body on a Protocol on Illicit Trade in Tobacco Products, FCTC/COP/5/7, May 11, 2012, available at <> (last visited May 21, 2012).
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