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

Published online by Cambridge University Press:  01 January 2021

Jonathan Liberman
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In her opening address to the 2011 session of the World Health Organization's (WHO) governing body, the World Health Assembly, WHO's Director-General, Dr. Margaret Chan, noted that WHO's job was much more straightforward when it was dealing mainly with germs, hygiene, medicines, vaccines and sister sectors, like water supply and sanitation. Today, international public health governance is much more complex. It is not only about forging agreement around shared health problems, but also being concerned with health as an outcome of global policies in areas such as trade, intellectual property, and human rights and, nationally, as an outcome of work in other sectors such as education, agriculture and the environment. Global health governance is increasingly fragmented, and WHO is not the only health game in town.

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Independent
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Journal of Law, Medicine & Ethics , Volume 40 , Issue 2 , Summer 2012 , pp. 326 - 347
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Copyright © American Society of Law, Medicine and Ethics 2012

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References

Chan, M., “The WHO Director-General Reminds Health Officials: Never Forget the People,” Address to the Sixty-fourth World Health Assembly, Geneva, Switzerland, May 16, 2011, available at <http://www.who.int/dg/speeches/2011/wha_20110516/en/> (last visited March 23, 2012).Google Scholar
World Health Organization, The Future of Financing for WHO. World Health Organization: Reforms for a Healthy Future, Report by the Director-General, A64/4, May 5, 2011, at para. 27 (hereinafter cited as WHO The Future of Financing).Google Scholar
Liberman, J. Mitchell, A., “In Search of Coherence between Trade and Health: Inter-Institutional Opportunities,” Maryland Journal of International Law 25 (2010): 143–186, at 153–154; Taylor, A. L., “Governing the Globalization of Public Health,” Journal of Law, Medicine & Ethics 32, no. 3 (2004): 500–508, at 502–503; Gostin, L. O. Taylor, A. L., “Global Health Law: A Definition and Grand Challenges,” Public Health Ethics 1, no. 1 (2008): 53–63, at 60; Fidler, D. P. Drager, N. Lee, K., “Managing the Pursuit of Health and Wealth: The Key Challenges,” The Lancet 373, no. 9660 (2009): 325–331, at 327.Google Scholar
Kickbusch, I. Hein, W. Silberschmidt, G., “Addressing Global Health Governance Challenges through a New Mechanism: The Proposal for a Committee C of the World Health Assembly,” Journal of Medicine, Law & Ethics 38, no. 3 (2010): 550–563, at 551.CrossRefGoogle Scholar
See World Health Organization, supra note 2, at para. 3.Google Scholar
Id.Google Scholar
Id.Google Scholar
World Health Assembly, The WHO Reform, 64th sess, WHA 64.2, 9th plen mtg, A/64/VR/9 (20 May 2011); see Chan, M., The Future of Financing for WHO: Introductory Remarks at an Informal Consultation on the Future of Financing for WHO, Geneva, Switzerland, January 12, 2010, available at <http://www.who.int/dg/speeches/2010/financing_who_20100112/en/> (last visited March 23, 2012).Google Scholar
World Health Organization, supra note 2, at para. 20.Google Scholar
Constitution of the World Health Organization, New York, July 22, 1946), at art. 1.Google Scholar
Id., at para. 2(a)Google Scholar
Id., at para. 2(b).Google Scholar
World Health Organization, supra note 2, at para. 37.Google Scholar
Id.Google Scholar
Id., at para. 9.Google Scholar
Id., at para. 40.Google Scholar
Id.Google Scholar
WHO Framework Convention on Tobacco Control, May 21, 2003, 2302 U.N.T.S. 166.Google Scholar
Liberman, J. et al. , “Opportunities and Risks of the Proposed FCTC Protocol on Illicit Trade,” Tobacco Control 20 (2011): 436–438.CrossRefGoogle Scholar
World Health Organization, WHO Technical Manual on Tobacco Tax Administration (2010); International Agency for Research in Cancer, IARC Handbooks of Cancer Prevention: Tobacco Control, Volume 14: Effectiveness of Price and Tax Policies for Control of Tobacco, Lyon, France, 2011.Google Scholar
Black's Law Dictionary, 9th ed., 2009.Google Scholar
Id.Google Scholar
Agreement on Trade-Related Aspects of Intellectual Property Rights, Marrakesh Agreement Establishing the World Trade Organization, at Annex 1C, Marrakesh, April 15, 1994 (hereinafter cited as TRIPS Agreement).Google Scholar
Id., at art. 41.Google Scholar
Id., at art. 44.Google Scholar
Id., at art. 45.Google Scholar
Id., at art. 50.Google Scholar
Id., at art. 51 fn.Google Scholar
Id., at art. 51.Google Scholar
Id., at art. 61.Google Scholar
World Health Organization, “Medicines: Spurious/Falsely-Labelled/Falsified/Counterfeit (SFFC) Medicines,” Fact sheet No. 275, January 2010, available at <http://www.who.int/mediacentre/factsheets/fs275/en/index.html> (last visited March 23, 2012).+(last+visited+March+23,+2012).>Google Scholar
Davison, M. J. Monotti, A. L. Wiseman, L., Australian Intellectual Property Law (Cambridge: Cambridge University Press, 2008): At 66.CrossRefGoogle Scholar
See World Health Organization, supra note 31.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Bunker, A., “Deadly Dose: Counterfeit Pharmaceuticals, Intellectual Property and Human Health,” Journal of the Patent and Trademark Office Society 89, no. 6 (2007): 493–515, at 508; Nelson, M. Vizurraga, M. Chang, D., “Counterfeit Pharmaceuticals: A Worldwide Problem,” Trademark Reports 96, no. 5 (2006): 1068–1100, at 1072.Google Scholar
World Health Organization, Medium-Term Strategic Plan 2008–2013. World Health Organization 2007.Google Scholar
World Health Organization, “Essential Medicines and Pharmaceutical Policies,” available at <http://www.who.int/medicines/en/> (last visited March 23, 2012).+(last+visited+March+23,+2012).>Google Scholar
World Health Assembly, “Rational Use of Drugs,” 41st sess., WHA41.16, Hbk Res., Vol. III (1st ed.), 1.15.2 (Fifteenth plenary meeting, May 13, 1988 – Committee A, second report).Google Scholar
World Health Assembly, “Rational Use of Drugs; and the WHO Action Programme on Essential Drugs,” 47th sess., WHA 47.13, Res., Vol. III (3rd ed.), 1.15.2 (Twelfth plenary meeting, 10 May 1994 – Committee A, second report).Google Scholar
World Health Organization, “Counterfeit Medical Products, International Medical Products Anti-Counterfeiting Taskforce,” Report by the Secretariat, A63/23, April 22, 2010, at para. 4.Google Scholar
World Health Organization International Conference, Combating Counterfeit Drugs: Building Effective International Collaboration (‘Declaration of Rome’), February 18, 2006 at para. 1.Google Scholar
Id., at para. 2.Google Scholar
Id., at para. 3.Google Scholar
Id., at para. 4.Google Scholar
Id., at para. 6.Google Scholar
Id., at para. 2.Google Scholar
Id., at para. 4.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at para. 5.5.Google Scholar
World Health Assembly, 61st sess., Committee A, 10th mtg., May 23, 2008.Google Scholar
World Health Assembly, Executive Board, 124th sess., 9th mtg., January 23, 2009.Google Scholar
World Health Organization, “World Health Assembly Closes with Resolutions on Public Health,” May 22, 2009, available at <http://www.who.int/mediacentre/news/releases/2009/world_health_assembly_20090522/en/index.html> (last visited March 23, 2012).+(last+visited+March+23,+2012).>Google Scholar
World Health Organization, “Counterfeit Medical Products,” Report by the Secretariat, April 22, 2010, A63/23.Google Scholar
World Health Organization, “Counterfeit Medical Products, International Medical Products Anti-Counterfeiting Taskforce,” Report by the Secretariat, April 22, 2010, A63/INF. DOC./3.Google Scholar
World Health Assembly, 63rd sess, Committee A, 6th mtg., A/63/A/PSR/6, May 19, 2010, at 5.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at 6.Google Scholar
Id.Google Scholar
Id., at 9.Google Scholar
Id.Google Scholar
Id., at 15. See also Third World Network, “WHO's ‘Counterfeit’ Programme: Legitimises IP Enforcement Agenda, Undermines Public Health,” Briefing Paper, 63rd World Health Assembly, May 17–21, 2010, Geneva, Switzerland; Third World Network, “NGOs concerned over WHO's role in ‘Counterfeit’ Drugs, IMPACT,” SUNS #6924, May 17, 2010, at 8, available at <http://www.twnside.org.sg/title2/health.info/2010/health20100504.htm> (last visited March 23, 2012); Third World Network et al., “NGO Open Letter Expressing Concern Over WHO's Involvement in ‘Counterfeit Medical Products’ and in the International Medical Product Anti-Counterfeit Taskforce (IMPACT),” May 2010, “Open Letter to Dr Margaret Chan, Director General of the World Health Organization,” available at <www.intal.be/files/Open_letter_Margaret_Chan.pdf> (last visited April 11, 2012). (last visited March 23, 2012); Third World Network et al., “NGO Open Letter Expressing Concern Over WHO's Involvement in ‘Counterfeit Medical Products’ and in the International Medical Product Anti-Counterfeit Taskforce (IMPACT),” May 2010, “Open Letter to Dr Margaret Chan, Director General of the World Health Organization,” available at (last visited April 11, 2012).' href=https://scholar.google.com/scholar?q=66+Id.,+at+15.+See+also+Third+World+Network,+“WHO's+‘Counterfeit’+Programme:+Legitimises+IP+Enforcement+Agenda,+Undermines+Public+Health,”+Briefing+Paper,+63rd+World+Health+Assembly,+May+17–21,+2010,+Geneva,+Switzerland;+Third+World+Network,+“NGOs+concerned+over+WHO's+role+in+‘Counterfeit’+Drugs,+IMPACT,”+SUNS+#6924,+May+17,+2010,+at+8,+available+at++(last+visited+March+23,+2012);+Third+World+Network+et+al.,+“NGO+Open+Letter+Expressing+Concern+Over+WHO's+Involvement+in+‘Counterfeit+Medical+Products’+and+in+the+International+Medical+Product+Anti-Counterfeit+Taskforce+(IMPACT),”+May+2010,+“Open+Letter+to+Dr+Margaret+Chan,+Director+General+of+the+World+Health+Organization,”+available+at++(last+visited+April+11,+2012).>Google Scholar
World Health Assembly, A/63/A/PSR/6, at 7–8. The candidate countries Turkey, Croatia and the former Yugoslav Republic of Macedonia, the countries of the Stabilisation and Association Process and potential candidates Albania, Bosnia and Herzegovina, Montenegro and Serbia, as well as Ukraine, the Republic of Moldova, Armenia and Georgia aligned themselves with this statement.Google Scholar
Id., at 7.Google Scholar
Id., at 8.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at 13.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at 14.Google Scholar
Id., at 14.Google Scholar
Id., at 13.Google Scholar
Id., at 14.Google Scholar
Id.Google Scholar
World Health Assembly, “Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products,” WHA 63(10), 63rd sess., 8th plenary meeting, May 21, 2010.Google Scholar
Id., at para. 3.Google Scholar
Chan, M., “Turn of the Tap of Unsafe Medicines,” Opening remarks at the Working Group of Member States on Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit Medical Products, Geneva, Switzerland, February 28, 2011, at 8, available at <http://www.who.int/dg/speeches/2011/ncds_20110228/en/index.html> (last visited March 23, 2012).Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
World Health Organization Working Group of Member States on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, Report of the Working Group of Member States on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, Annex to Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, A64/16, March 24, 2011.Google Scholar
Id., at para. 10 bis.Google Scholar
Id., at para. 18.Google Scholar
World Health Assembly, Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, 64th sess., Fifth Report of Committee A, (Draft) A64/61, Agenda Item 13.7.Google Scholar
World Health Organization Working Group of Member States on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, Report of the Working Group of Member States on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, Annex to Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products: Report of the Working Group of Member States (EB130/22) at para. 5.Google Scholar
Id., at para. 6.Google Scholar
Id., at para. 7.Google Scholar
Id., at para. 11 and Appendix 2 (“Goal, Objective and Terms of Reference”).Google Scholar
Id., at paras. 9 and 10, and Appendix 1 (“Draft Resolution”), para. 4.Google Scholar
World Health Assembly Executive Board, Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, 130th session EB130.R13, January 21, 2012.Google Scholar
World Health Assembly, Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, 61st sess., WHA 61.21, Eighth plenary meeting, 24 May 2008 – Committee A, (fifth report) at para. 33.Google Scholar
Id., at 34.Google Scholar
Id.Google Scholar
World Health Organization, “About PHI,” available at <http://www.who.int/phi/about/en/> (last visited March 28, 2012).+(last+visited+March+28,+2012).>Google Scholar
E.U. Regulation (1383/2003).Google Scholar
Clift, C., “Combating Counterfeit, Falsified and Substandard Medicines: Defining the Way Forward?” Chatham House Briefing Paper (2010): At 4; Dounis, C., “Enforcing Intellectual Property Rights Via EU Border Regulations: Inhibiting Access to Medicine or Preventing Counterfeit Medicine?” Brooklyn Journal of International Law 36, no. 2 (2011): 717–750, at 717; Outterson, K., “Import Safety Rules and Generic Drug Markets,” in Coglianese, C., et al., eds., Import Safety: Regulatory Governance in the Global Economy, 1st ed. (2009): At 111–113. See also Medicins Sans Frontieres, Letter sent to Mr. Kovács, László, European Commissioner for Taxation and Customs Union, and to Baroness Catherine Ashton, European Commissioner for Trade (February 12, 2009), available at <http://www.msfaccess.org/content/msf-letter-ec-over-dutch-generics-seizure> (last visited April 11, 2012); Oxfam, , Eye on the Ball: Medicine Regulation – Not IP Enforcement – Can Best Deliver Quality Medicines, Oxfam Briefing Paper 143, at 30, February 2, 2011), available at <http://www.oxfam.org/sites/www.oxfam.org/files/eye-on-the-ball-medicine-regulation-020211-en.pdf> (last visited March 28, 2012).+(last+visited+April+11,+2012);+Oxfam,+,+Eye+on+the+Ball:+Medicine+Regulation+–+Not+IP+Enforcement+–+Can+Best+Deliver+Quality+Medicines,+Oxfam+Briefing+Paper+143,+at+30,+February+2,+2011),+available+at++(last+visited+March+28,+2012).>Google Scholar
Id.Google Scholar
World Trade Organization, Council for Trade-Related Aspects of Intellectual Property Rights, Minutes of Meeting Held 3 March 2009, IP/C/M/59, May 25, 2009.Google Scholar
World Trade Organization, Council for Trade-Related Aspects of Intellectual Property Rights, Minutes of Meeting Held 8–9 June 2009, IP/C/M/60, September 28, 2009.Google Scholar
World Trade Organization, Council for Trade-Related Aspects of Intellectual Property Rights, Minutes of Meeting Held 3 March 2009, IP/C/M/59, May 25, 2009, para. 123.Google Scholar
Id., para. 132.Google Scholar
Id., at para. 133.Google Scholar
Id., at para. 137.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at para. 147.Google Scholar
Id., at para. 149.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at 159.Google Scholar
World Trade Organization, Council for Trade-Related Aspects of Intellectual Property Rights, Minutes of Meeting held 8–9 June 2009, IP/C/M/60, September 28, 2009, para. 116 (hereinafter cited as WTO Council).Google Scholar
World Trade Organization Ministerial Conference, Declaration on the TRIPS Agreement and Public Health Adopted on 14 November 2001, WT/MIN(01)/DEC/d (November 20, 2001).Google Scholar
See WTO Council, supra note 120, at para. 118.Google Scholar
Id., at para. 128.Google Scholar
Id., at para. 143.Google Scholar
Id.Google Scholar
World Trade Organization, Understanding on Rules and Procedures Governing the Settlement of Disputes, Agreement on Trade-Related Aspects of Intellectual Property Rights, Marrakesh Agreement Establishing the World Trade Organization, Annex 2, Marrakesh, April 15, 1994 (hereinafter cited as TRIPS Agreement).Google Scholar
World Trade Organization, “European Union and a Member State – Seizure of Generic Drugs in Transit (India),” available at <http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds408_e.htm> (last visited March 28, 2012); and World Trade Organization, “European Union and a Member State – Seizure of Generic Drugs in Transit (Brazil),” available at <http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds409_e.htm> (last visited March 28, 2012). See also Zarocastas, J., “Brazil and India File Complaint against EU over Seizure of Generic Drugs,” BMJ (Overseas & Retired Doctors Edition) 340, no. 7757 (2010): 1107.Google Scholar
Press Information Bureau, Government of India, “India EU Reach an Understanding on Issue of Seizure of Indian Generic Drugs in Transit,” July 28, 2011, available at <http://pib.nic.in/newsite/erelease.aspx?relid=73554> (last visited March 28, 2012).+(last+visited+March+28,+2012).>Google Scholar
von Braunn, J. Munyi, P., “New Enforcement Mechanisms Challenge the Legality of Generics in the Name of Public Health: The Emergence of Anti-Counterfeiting Legislation in East Africa,” African Journal of International and Comparative Law 18, no. 2 (2010): 238–253, at 238; Mulumba, M., “Anti-Counterfeiting Legislation in East Africa: A New Assault Against TRIPS Flexibilities for Access to Medicine?” Equinet Newsletter 111 (May 1, 2010), available at <http://www.equinetafrica.org/newsletter/index.php?issue=111> (last visited March 28, 2012); see Outterson, , supra note 105, at 120–121.CrossRefGoogle Scholar
The Anti-Counterfeit Bill, 2008 (Kenya).Google Scholar
Id., at s2(a).Google Scholar
The Counterfeit Goods Bill, 2009 (Uganda).Google Scholar
Id., at s2(a).Google Scholar
The Anti Counterfeiting Goods Bill, 2010 (Uganda).Google Scholar
Id., at s2.Google Scholar
Id.Google Scholar
Id.Google Scholar
Mullard, A., “EU Implicated in Controversial Counterfeiting Bill,” The Lancet 375, no. 9723 (2010): 1335. See also, Wambi, M., “US Intensifies Anti-counterfeit Drive in East Africa,” IPS News (July 19, 2010), available at <http://ipsnews.net/news.asp?idnews=52228> (last visited March 28, 2012); Agazzi, I., “East African Laws Confuse Fake and Generic Drugs – WHO,” IPS Africa (July 19, 2010), available at <http://www.ips.org/africa/2010/07/health-east-african-laws-con-fuse-fake-and-generic-drugs-who/> (last visited March 28, 2012); Medicins Sans Frontieres, “Ten Stories That Mattered in Access to Medicines in 2010,” available at <http://msfindia.in/content.php?con_id=80> (last visited March 28, 2012).CrossRefGoogle Scholar
Australian Government Department of Foreign Affairs and Trade, Anti-Counterfeiting Trade Agreement, available at <http://www.dfat.gov.au/trade/acta/> (last visited March 28, 2012).+(last+visited+March+28,+2012).>Google Scholar
Id.Google Scholar
Sell, S., “The Global IP Upward Ratchet, Anti-Counterfeiting and Piracy Enforcement Efforts: The State of Play,” PIJIP 15 (2010): 1–22, at 2.Google Scholar
Id.Google Scholar
Id., at 3.Google Scholar
Id., at 11.Google Scholar
Id.Google Scholar
Id., at 12; see also Yu, P., “Enforcement, Economics and Estimates,” WIPO Journal 2, no. 1 (2010): 1–19, at 2–6; Kumar, S., “International Trade, Public Health, and Intellectual Property Maximalism: The Case of European Border Enforcement and Trade in Generic Pharmaceuticals,” Global Trade and Customs Journal 5, no. 4 (2010): 155–169, at 155.Google Scholar
See Sell, , supra note 141, at 17.Google Scholar
See TRIPS Agreement, supra note 23, at preamble.Google Scholar
United Nations Office on Drugs and Crime, The Globalization of Crime: A Transnational Organized Crime Assessment (2010).Google Scholar
Id., at ch. 8.Google Scholar
Id., at 173.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at 174.Google Scholar
Id., at 173.Google Scholar
World Customs Organization, Enforcement and Compliance - Responsibilities: The WCO and the Protection of Intellectual Property Rights (IPR), available at <http://www.wcoomd.org/valelearningoncustomsvaluation_eftobaccoandcigarettesmuggling.htm> (last visited April 3, 2012) (hereinafter cited as WCO Enforcement and Compliance).+(last+visited+April+3,+2012)+(hereinafter+cited+as+WCO+Enforcement+and+Compliance).>Google Scholar
Id.Google Scholar
Id.Google Scholar
World Customs Organization, Intellectual Property Rights, available at <http://www.wcoomd.org/detailsipr.htm> (last visited March 28, 2012).+(last+visited+March+28,+2012).>Google Scholar
See WCO Enforcement and Compliance, supra note 158.Google Scholar
The International Criminal Police Organization (INTERPOL), “Intellectual Property Rights (IPR) Programme,” available at <http://www.interpol.int/public/financialcrime/intellectualproperty/default.asp> (last visited July 8, 2011).+(last+visited+July+8,+2011).>Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
United Nations Commission on Crime Prevention and Criminal Justice, “Mandate and Functions,” available at <http://www.unodc.org/unodc/en/commissions/CCPCJ/ccpcj-man-date-functions.html> (last visited March 28, 2012).+(last+visited+March+28,+2012).>Google Scholar
United Nations Commission on Crime Prevention and Criminal Justice, Report on the Twentieth Session (December 3, 2010 and April 11–15, 2011).Google Scholar
Id.Google Scholar
Id., at preamble.Google Scholar
Id.Google Scholar
United Nations Convention Against Transnational Organized Crime, U.N.T.S. vol. 2225, No. 39574.Google Scholar
United Nations Commission on Crime Prevention and Criminal Justice, Report on the Twentieth Session, supra note 169, at preamble.Google Scholar
Id., at operative para. 1.Google Scholar
Id., at operative para. 2.Google Scholar
Id., at operative para. 3.Google Scholar
Id., at operative para. 4.Google Scholar
Id., at operative para. 8.Google Scholar
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).Google Scholar
Council of Europe, Medicrime: Introduction, available at <http://www.coe.int/t/DGHL/StandardSetting/MediCrime/Default_en.asp> (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.”+(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.”>Google Scholar
See MEDICRIME Convention, supra note 180, at Article 4j.Google Scholar
Id., at preamble.Google Scholar
Id.Google Scholar
Id., at art. 5.Google Scholar
Id., at art. 6.Google Scholar
Id., at art. 7.Google Scholar
Id., at art. 8.Google Scholar
Id., at art. 10.Google Scholar
Id., at art. 11.Google Scholar
Id., at art. 12.Google Scholar
Id., at art. 15–16.Google Scholar
Id., at art. 17.Google Scholar
Id., at art. 18.Google Scholar
Id., at art. 19–20.Google Scholar
Id., at art. 21–22.Google Scholar
Council of Europe Communications, Counterfeit Medical Products: Twelve Countries Join the Council of Europe Medicrime Convention, October 28, 2011, available at <http://www.edqm.eu/medias/fichiers/medicrime_convention_opened_for_signature.pdf> (last visited March 28, 2012).+(last+visited+March+28,+2012).>Google Scholar
See World Health Organization, Reforms for a Healthy Future, supra note 2, at para. 20.Google Scholar
Silberschmidt, G., “How to Set Priorities for the World Health Organization,” Global Health Programme Working Paper No. 6 (2011): At 6.Google Scholar
Id., 8.Google Scholar
World Health Assembly, A/63/A/PSR/6, at 14.Google Scholar
See Chan, , supra note 85.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
See World Health Organization Executive Board, supra note 99.Google Scholar
Id.Google Scholar
See Declaration of Rome, supra note 44, at para. 3.Google Scholar
Park, S., “Legal Aspects of Defining ‘Counterfeit Medicines’: A Discussion Paper,” World Health Organization Regional Office South East Asia (2009): At 1.Google Scholar
Id., 1–2; Caudron, J. M. 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.CrossRefGoogle Scholar
Id., at 1068.Google Scholar
Id.Google Scholar
Outterson, K. Smith, R., “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.Google Scholar
See Liberman, et al. , supra note 19; Boister, N. McGrady, B., “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.Google Scholar
World Health Organization Framework Convention on Tobacco Control Convention Secretariat, “Parties to the WHO Framework Convention on Tobacco Control,” available at <http://www.who.int/fctc/signatories_parties/en/index.html> (last visited March 28, 2012).+(last+visited+March+28,+2012).>Google Scholar
Id., art. 3.Google Scholar
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).Google Scholar
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).Google Scholar
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).Google Scholar
Id.Google Scholar
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).Google Scholar
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.Google Scholar
Id., at preamble.Google Scholar
Id., at art. 5.Google Scholar
Id., at art. 6.Google Scholar
Id., at art. 7.Google Scholar
Id., at art. 8.Google Scholar
Id., at art. 9.Google Scholar
Id.Google Scholar
Id., at art. 10.Google Scholar
Id., at art. 11.Google Scholar
Id.Google Scholar
Id. at art. 12.Google Scholar
Id., at art. 13.Google Scholar
Id., at art. 14.Google Scholar
Id., at art. 15.Google Scholar
Id., at art. 16.Google Scholar
Id., at art. 17.Google Scholar
Id., at art. 18.Google Scholar
Id., at art. 19.Google Scholar
Id., at art. 20–22.Google Scholar
Id., at art. 23–24.Google Scholar
Id., at art. 25.Google Scholar
Id., at art. 27. 545. Id., at art. 28.Google Scholar
Id., at art. 29.Google Scholar
Id., at art. 30.Google Scholar
Id., at art. 31.Google Scholar
See Black's Law Dictionary, supra note 21.Google Scholar
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.Google Scholar
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.Google Scholar
See World Health Organization, supra note 20; International Agency for Research in Cancer, supra note 20.Google Scholar
Draft Protocol to Eliminate Illicit Trade in Tobacco Products, supra note 222, at art. 12.1(b)(i).Google Scholar
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.Google Scholar
See MEDICRIME Convention, supra note 180, at preamble.Google Scholar
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.Google Scholar
Id., at Guiding Principle 1.Google Scholar
World Health Organization, Engaging and Working with the Commercial Private Sector, WHO Policy Framework, September 2010, at para. 13.Google Scholar
Id.Google Scholar
See generally International Tax and Investment Center, The Illicit Trade in Tobacco Products and How to Tackle It, 2010, available at <www.iticnet.org/Download.aspx?QSDOCID=2759> (last visited March 28, 2012).+(last+visited+March+28,+2012).>Google Scholar
See Liberman, et al. , supra note 19.Google Scholar
Blecher, E., “Commentary on Joossens et al. (2010): 'Eliminating the Global Illicit Cigarette Trade — What Do We Really Know?” Addiction 105, no. 9 (2010): 1650–1651.CrossRefGoogle Scholar
See Liberman, et al. , supra note 19.Google Scholar
British American Tobacco, “About Illicit Trade,” available at <http://www.bat.com/group/sites/uk__3mnfen.nsf/vwPagesWebLive/DO6TNKVW?opendocument&SKN=1> (last visited March 28, 2012).+(last+visited+March+28,+2012).>Google Scholar
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.Google Scholar
Boister, N., “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.CrossRefGoogle Scholar
British American Tobacco, “How We Tackle Illicit Trade,” available at <http://www.bat.com/group/sites/uk__3mnfen.nsf/vwPagesWebLive/DO6TNLZ2?opendocument&SKN=1> (last visited March 28, 2012) (emphasis added).+(last+visited+March+28,+2012)+(emphasis+added).>Google Scholar
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.Google Scholar
Id., at para. 9.Google Scholar
Id., at para. 10.Google Scholar
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.Google Scholar
See Liberman, et al. , supra note 19.Google Scholar
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.Google Scholar
Draft Protocol to Eliminate Illicit Trade in Tobacco Products, supra note 222, at art. 36.1.Google Scholar
World Health Assembly, A/63/A/PSR/6, at 14.Google Scholar
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.Google Scholar
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 <http://apps.who.int/gb/fctc/E/E_cop5.htm> (last visited May 21, 2012).+(last+visited+May+21,+2012).>Google Scholar