Why and how to make an international crime of medicine counterfeiting

Journal of International Criminal Justice

Volumn 9, Issue 2, 2011, Pages 325-354

  Attaran, Amir ^a   Bate, Roger ^b   Kendall, Megan ^a  

^a UNIVERSITY OF OTTAWA   (Canada)

^b AMERICAN ENTERPRISE INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 79955446337     PISSN: 14781387     EISSN: 14781395     Source Type: Journal    
DOI: 10.1093/jicj/mqr005     Document Type: Article

References (101)

1. Decision on the Defence Motion for Interlocutory Appeal on Jurisdiction, Tadic (IT-94-1-AR72), Appeals Chamber, 2 October 1995, § 58.
2. R. Cockburn et al., 'The Global Threat of Counterfeit Drugs: Why Industry and Governments must Communicate the Dangers', 2 PLoS Medicine (2005) e100.
3. See World Health Organization (WHO), 'Counterfeit medicines', Fact sheet No. 275, available at http://www.who.int/mediacentre/factsheets/fs275/en/index.html (visited 24 November 2010).
4. A.M. Dondorp et al.,'Fake antimalarials in Southeast Asia are a major impediment to malaria control: Multinational cross-sectional survey on the prevalence of fake antimalarials', 9 Tropical Medicine and International Health (2004) 1241-1246.
5. See P. Taylor, 'Counterfeiting conference to hear of burden in developing world' (InPharmaTechnologist), available at http://www.in-pharmatechnologist.com/Industry-Drivers/Counterfeiting-conference-to-hear-of-burden-in-developing-world (visited 24 November 2010).
6. International Convention for the Suppression of Counterfeiting Currency, 20 April 1929 (hereafter, 'Currency Convention'), at Art. 18.
7. Pharmaceutical Security Institute, 'Incident Trends', available at http://www.psi-inc.org/incidentTrends.cfm (visited 24 November 2010).
8. R. Bate and K. Hess,'Anti-malarial Drug Quality in Lagos and Accra - a Comparison of Various QualityAssessments', 9 Malaria Journal (2010) 157.
9. See WHO,'Counterfeit medicines', Fact sheet No. 275, revision of 14 November 2006, available at http://web.archive.org/web/20080724031944/http://www.who.int/mediacentre/factsheets/fs275/en/(visited 24 November 2010); See Center for Medicine in the Public Interest, 'Counterfeit drugs and China New', available at http://www.cmpi.org/in-the-news/testimony/counterfeit-drugs-and-china-new (visited 24 November 2010).
10. L. Gibson, 'Drug regulators study global treaty to tackle counterfeit drugs', 328 British Medical Journal (2004) 486.
11. Counterfeit Drugs: Guidelines for the development of measures to combat counterfeit drugs, UN Doc. WHO/EDM/QSM/99.1, 1999.
12. T.K. Mutabingwa, 'Artemisinin-based Combination Therapies (ACTs): Best Hope for Malaria Treatment but Inaccessible to the Needy!' 95 ActaTropica (2005) 305-315.
13. USAID in association with US Pharmacopia maintains a 'Matrix of Medicine Quality', documenting hundreds of counterfeit drug incidents in countries assisted by USAID: See 'Media Reports on Medicine Quality: Focusing on USAID-assisted Countries' (Promoting the Quality of Medicines program) available at http://www.usp.org/pdf/EN/dqi/ghcDrugQualityMatrix.pdf (visited 24 November 2010).
14. P.N. Newton et al., 'A Collaborative Epidemiological Investigation into the Criminal Fake Artesunate Trade in South East Asia', 5 PLoS Medicine (2008) e 32.
15. P.N. Newton, R. McGready et al., 'Manslaughter by Fake Artesunate in Asia - will Africa be Next?' 3 PLoS Medicine (2006) e197.
16. P.N. Newton et al., 'Counterfeit Anti-infective Drugs', 6 The Lancet Infectious Diseases (2006) 602-613.
17. V. Reggi, 'Counterfeit Medicines: An Intent to Deceive', 19 The International Journal of Risk and Safety in Medicine (2006) 105.
18. C. Clarke,'Counterfeiting Abroad and at Home', 271 The Pharmaceutical Journal (2003) 453-454.
19. See R. Bate,'Lessons from a Syrian Drug Bust', Wall Street Journal (28 April 2010), available at http://online.wsj.com/article/SB10001424052748704423504575211920119322724.html (visited 24 November 2010).
20. L. Beck,'China to Extend "Arduous" Drug Industry Clean-Up', Reuters (3 December 2007).
21. See Philippines,'Special Law on Counterfeit Drugs', Republic Act, No. 8203 (Chan Robles Virtual Law Library) available at www.chanrobles.com/republicactno8203.htm (visited 24 November 2010).
22. See R. Bate, 'Fighting Fake Drugs in India', The American (18 November 2008), available at http://www.american.com/archive/2008/november-11-08/fighting-fake-drugs-in-india (visited 24 November 2010).
23. M.C. Bassiouni and E.M. Wise, Aut dedere aut judicare: The Duty to Extradite or Prosecute in International Law (Dordrecht: Martinus Nijhoff Publishers,1995).
24. See S. Nebehay,'Counterfeit Drugs on Rise, Pose Global Threat - WHO', Reuters (20 May 2010), available at http://www.alertnet.org/thenews/newsdesk/LDE64I26E.htm (visited 24 November 2010).
25. See WHO, 'What Encourages Counterfeiting of Medicines?' available at http://www.who.int/medicines/services/counterfeit/faqs/15/en/index.html (visited 24 November 2010).
26. M.A. Atemnkeng, K. De Cock and J. Plaizier-Vercammen,'Quality Control of Active Ingredients in Artemisinin-derivative Antimalarials within Kenya and DR Congo', 12 Tropical Medicine & International Health (2007) 68-74.
27. See Kenyan Ministry of Health, 'Antimalarial Medicines in Kenya' available at http://apps.who.int/medicinedocs/documents/s16424e/s16424e.pdf (visited 24 November 2010).
28. J.C. Cohen, M. Mrazek and L. Hawkins, 'Tackling Corruption in the Pharmaceutical Systems Worldwide with Courage and Conviction', 81 Clinical Pharmacology and Therapeutics (2007) 445-449.
29. Consider malaria, a disease that kills nearly a million people, mostly children, annually. Those suffering from the disease in Africa, Asia and elsewhere often self-diagnose and self-treat, without medical supervision and using drugs they purchase in the market. Problem is, the leading treatments in the market (the artemisinin-class drugs) are increasingly counterfeited. Recent studies show that in South-East Asia, a staggering 33-53% of these medicines contain no active ingredient, and scientists warn that the trend is similar in Africa. See J. Harris, P. Stevens and J. Morris,'Keeping It Real: Combating the Spread of Fake Drugs in Poor Countries', (International Policy Network) available at http://www.policynetwork.net/sites/default/files/keeping_it_real_2009.pdf (visited 24 November 2010).
30. Editorial,'Combating Counterfeit Drugs', 371 Lancet (2008) 1551.
31. In Haiti, India, Nigeria and Bangladesh, some 500 children died after consuming counterfeit paracetamol (acetaminophen) cough syrup made with diethylene glycol, a renal toxin used in antifreeze.
32. In Niger, during a meningitis outbreak in 1995, about 60,000 people were immunized with a vaccine donated by neighbouring Nigeria, which regrettably turned out to be counterfeit Lacking protection from the deadly disease, about 2,500 people, mostly children, died. See J. Pinel et al., 'Des Faux Vaccins Anti-meningocoque lors d'une Epidemie de Meningite au Niger', 27 Medecine et maladies infectieuses (1997) 1-563.
33. M. Chauve, 'La lutte Contre la Contrefacon de Medicaments en Afrique: Experiences et Role des Pharmaciens', 331 Comptes Rendus Biologies (2008) 982-985.
34. In Brazil, about 200 unplanned pregnancies occurred when a test batch of oral contraceptives made by Schering Brasil containing wheat flour rather than active ingredient was stolen, packaged as if it was real, and sold. (C. Claudio, 'Epidemic of Counterfeit Drugs Causes Concern in Brazil', 352 Lancet (1998) 553). Schering executives, deplorably, covered up the theft.
35. In Canada, pharmacies in Ontario were discovered selling a counterfeit version of a blood pressure medicine, Norvasc, after 11 patients inexplicably died. (See Criminal Intelligence Service Canada,'Counterfeit Pharmaceuticals in Canada' (Government of Canada) available at http://www.cisc.gc.ca/pharmaceuticals/pharmaceuticals_e.html(visited 24 November 2010)). A Coroner's enquiry was unable to rule out 'possible unauthorized medication substitution' in some of those deaths. See Ontario College of Pharmacists,'Discipline Case: Bhusmang Mehta', available at http://www.ocpinfo.com/client/ocp/ocphome.nsf/ab26815c7d6d78e58525732b00626f24/aa6045f7b9733ec9852570d10060b1d1?OpenDocument(visited 24 November 2010).
36. In the United States, the Food and Drug Administration recalled 18 million tablets of an anti-cholesterol drug, Lipitor, after counterfeits infiltrated distribution channels. A subsequent investigation by Lipitor's manufacturer revealed an incredibly audacious global criminal enterprise at work: 'the counterfeits had been manufactured in Costa Rica using tooling and excipients from the United States and a pharmaceutical ingredient shipped from the Hong Kong office of Swiss company.' See Pfizer, 'Case Study: Lipitor US Recall', available online at http://media.pfizer.com/files/products/LipitorUSRecall.pdf (visited 24 November 2010).
37. P. Aldhous, 'Counterfeit Pharmaceuticals: Murder by Medicine', 10 Nature (March 2005) 132-136.
38. K.A. Hall et al.,'Characterization of Counterfeit Artesunate Antimalarial Tablets from Southeast Asia', 75 American Journal of Tropical Medicine and Hygiene (2006) 804-811.
39. P. Olliaro, 'Drug Resistance Hampers Our Capacity to Roll Back Malaria', 41 Clinical Infectious Diseases (2005) S 247-S 257.
40. M.C. Bassiouni, 'The Penal Characteristics of International Criminal Law', 15 Case Western Reserve Journal of International Law (1983) 27, a t 28-29.
41. See 'Declaration of Rome', Conclusions and Recommendations of the WHO International Conference on Combating Counterfeit Medicines, 18 February 2006 at Section 4, available at http://www.who.int/medicines/services/counterfeit/RomeDeclaration.pdf (visited 26 November 2010).
42. See 'Draft Principles and Elements for National Legislation against Counterfeit Medical Products' (International Medical Products Anti-Counterfeiting Taskforce), available at http://www.who.int/entity/impact/events/PrinciplesElementsforNationalLegislation.pdf (visited 26 November 2010).
43. The industry delegation was headed by Michael J. Muller, the Director of Global Anti-Counterfeiting Operations for Eli Lilly & Company: Mr. Muller appeared influential in persuading other industry participants that a treaty was undesirable, and expressed this point of view to one of the authors (Attaran). Apparently it is feared that more robust enforcement against counterfeit medicines would draw publicity, and potentially undermine public confidence in the industry's products.
44. See 'Draft Council of Europe Convention on Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Health' (European Committee on Crime Problems), available online at http://www.coe.int/t/dghl/standardsetting/pharmacrime/CDPC%20_2009_15Fin%20E%20Draft%20Convention%2009%2011%2009CM.pdf (visited 26 November 2010).
45. Hague Convention for the Suppression of Unlawful Seizure of Aircraft, 860 UNTS 105; 22 UST 1641; 10 International Legal Materials (ILM) (1971) 133 (hereafter,'Hijacking Convention').
46. International Convention against the Taking of Hostages, GA Res. 34/146 (XXXIV), 34 UN GAOR Supp. (No. 46) at 245, UN Doc. A/34/46 (1979); 1316 UNTS 205; TIAS No. 11081; 18 ILM 1456 (1979).
47. Single Convention on Narcotics Drugs, 520 UNTS 204;18 UST 1407; 14 ILM (1975) 302; as amended by the Protocol Amending the Single Convention on Narcotic Drugs, 976 UNTS 3; 26 UST 1439; 11 ILM (1972) 804; Convention on Psychotropic Substances, 1019 UNTS 175; 32 UST 543; 10 ILM (1971) 261.
48. Intellectual property diehards who are tempted to include that subject in a counterfeit medicine treaty would be wise to recall that the last time public health and pharmaceutical intellectual property concerns collided - in the 2001 Doha Declaration on the TRIPS Agreement and Public Health - an enormous controversy erupted which in the end weakened, rather than strengthened, intellectual property protection.
49. See 'Combating Counterfeit Drugs: A Concept Paper for Effective Collaboration' (World Health Organization), available at http://www.who.int/medicines/services/counterfeit/CombatingCounterfeitDrugs_Conceptpaper.pdf (visited 26 November 2010), at 2.
50. The following should be punishable as ordinary crimes: Any fraudulent making or altering of currency, whatever means are employed; [...] Attempts to commit, and any intentional participation in, the foregoing acts; Note it is the 'intentional participation' (subparagraph 4) in the 'fraudulent making' (subpara-graph 1) of currency that is criminalized. This intelligent wording totally rules out accidental counterfeiting, since the manufacturing both has to be fraudulent, and the person doing the manufacturing must have intent to participate in the fraud.
51. A. Mullard, 'EU Implicated in Controversial Counterfeiting Bill', 375 Lancet (2010) 1335.
52. See J. Lynn, 'India, Brazil Challenge EU at WTO over Drugs', Reuters (12 May 2010), available at http://www.alertnet.org/thenews/newsdesk/LDE64B1O6.htm (visited 26 November 2010).
53. See S. Dey and K. Singh, 'WHO won't Redefine Fake Drugs', Economic Times (India) (27 January 2009), available at http://economictimes.indiatimes.com/rssarticleshow/4034234.cms?prt page=1 (visited 26 November 2010).
54. R. Bate and A. Attaran, 'A Counterfeit Drug Treaty: Great Idea, Wrong Implementation', 376 Lancet (2010) 1446.
55. In an act of dubious judgment, the Council of Europe welcomed Sanofi-Aventis to participate in the working group on the draft treaty, but without including generic medicine companies and NGOs from those discussions.
56. See 'WHO's 'Counterfeit' Programme Legitimises IP enforcement Agenda, Undermines Public Health', 63rd World Health Assembly, 17-21 May 2010 (Third World Network), available at http://www.twnside.org.sg/title2/briefing_papers/nontwn/Briefing.paper.on.WHO.Counterfeits.pdf (visited 26 November 2010), at 1.
57. D. Cahoy, 'Addressing the North-South Divide in Pharmaceutical Counterfeiting', 8 Wake Forest Intellectual Property Law Journal (2008) 407.
58. See L.P. Viana, 'New US IP Enforcement Plan May Have International Impact' (Intellectual Property Watch) available at http://www.ip-watch.org/weblog/2010/06/23/new-us-ip-enforce-ment-plan-may-have-international-impact/(visited 26 November 2010); See White House Office of Management and Budget, '2010 Joint Strategic Plan on Intellectual Property Enforcement' (June 2010), available online at http://www.whitehouse.gov/omb/assets/intellec tualproperty/intellectualproperty_strategic_plan.pdf. (visited 26 November 2010).
59. See W. Bogdanovich,'Counterfeit Drugs' Path Eased by Free Trade Zones', The NewYorkTimes (17 December 2007) available at http://www.nytimes.com/2007/12/17/world/middleeast/17freezo-ne.html?pagewanted=print (visited 26 November 2010).
60. See K. Tomlinson, 'Ex-worker Blows Whistle on Popular Web Pharmacy', CTV News (25 May 2006), available at http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20060510/whistle-blower_internetdrugs_060525/20060525/(visited 26 November 2010).
61. See J. Appleby, 'FDA: Tests of Cross-border Drugs Found Counterfeits', USA Today (30 August 2006), available at http://www.usatoday.com/money/industries/health/drugs/2006-08-30-fda-counterfeit-drugs_x.htm (visited 26 November 2010).
62. See J. Skerritt, 'Online Drug Pioneer Tumbles - Allegedly Retailed Counterfeit Meds', Winnipeg Free Press (24 February 2010), available at http://www.winnipegfreepress.com/breakingnews/online-drug-pioneer-tumbles-85182602.html?viewAllComments= (visited 25 November 2010).
63. C. Krauss, 'Going Global at a Small-Town Canadian Drugstore', The New York Times (5 March 2005), available at http://www.nytimes.com/2005/03/05/international/americas/05strempler.html (visited 25 November 2010).
64. See J. Skerritt, 'Online Pharmacist Eludes Ban: Strempler Moves Business to Caribbean, Manitoba Regulators can't Stop him now',Winnipeg Free Press (26 February 2010), available at http://www.winnipegfreepress.com/local/online-pharmacist-eludes-ban-85460077.html (visited 26 November 2010). See also the website of PharmaCheck: http://www.pharmacheck.com/contact.cfm.
65. These terms are better explained in G. Mettraux, 'Crimes Against Humanity in the Jurisprudence of the International Criminal Tribunals for the former Yugoslavia and for Rwanda', 43 Harvard International Law Journal (2002) 237. See also, the International Criminal Tribunal for Rwanda (ICTR) Trial Chamber decision in Akayesu (ICTR-96-4-T), 2 September 1998, § 580: 'The concept of "widespread" may be defined as massive, frequent, large-scale action, carried out collectively with considerable seriousness and directed against a multiplicity of victims. The concept of "systematic" may be defined as thoroughly organized and following a regular pattern on the basis of a common policy involving substantial public or private resources. There is no requirement that this policy must be adopted formally as the policy of a state. There must however be some kind of preconceived plan or policy.'.
66. T. Kelesidis et al., 'Counterfeit or Substandard Antimicrobial Drugs: a Review of the Scientific Evidence', 60 The Journal of Antimicrobial Chemotherapy (2007) 214-236.
67. P. Newton et al.,'Fake Artesunate in Southeast Asia', 357 Lancet (16 June 2001) 1948-1950.
68. Prior to recent jurisprudence, there has been debate about applying crimes against humanity to non-state criminal organizations (e.g. terrorist groups), and as Schabas writes, 'Whether crimes against humanity also reach into [this realm] ... can hardly be considered to be settled as a matter of law.' See W. Schabas, 'Punishment of Non-State Actors in Non-International Armed Conflict', 26 Fordham International Law Journal (2002) 907, at 929.
69. Decision Pursuant to Article 15 of the Rome Statute on the Authorization of an Investigation into the Situation in the Republic of Kenya (ICC-01/09-19), Pre-Trial Chamber II, 31 March 2010, § 92 et seq.
70. Judgment, Kayishema and Ruzindana (ICTR-95-1-T), Appeals Chamber, 21 May 1999, §§133-134.
71. Judgment, Kunarac, Kovac and Vukovic (IT-96-23 & IT-96-23/1-A), Appeals Chamber, 12 June 2002, § 130.
72. Art.7(2)(b) ICCSt.; It is of interest, here, to differentiate between extermination and murder - another act enumerated at Art. 7. In the Akayesu case, the ICTR Trial Chamber clarified that '[e]xtermination is a crime which by its very nature is directed against a group of individuals' and that 'it requires an element of mass destruction which is not required for murder' (Judgment, Akayesu (ICTR-96-4-T), Trial Chamber, 2 September 1998, §§ 591-592).
73. In the Nazi era, people were prosecuted under the crime of extermination for supplying cruel and unethical medical experiments with medicines, and for providing the concentration camps with 'medicines' (actually poison gas). While neither situation makes a perfect analogy, they affirm that those who commercialize a product on a widespread or systematic basis, with willful disregard that it will kill or harm, are viewed in the law as hostis humani generis. See 'The Farben Case', i n Trials of War Criminals Before the Nuerenberg Military Tribunals Under Control Council Law No. 10 (Washington: United States Government Printing Office, 1953); 'Trial of Bruno Tesch and Two Others' (The Zyklon B Case; British Military Court, Hamburg), in United Nations War Crimes Commission (ed.), Law Reports of Trials of War Criminals (London: HMSO, 1947); and K.R. Jacobson, 'Doing Business with the Devil: The Challenges of Prosecuting Corporate Officials Whose Business Transactions Facilitate War Crimes and Crimes Against Humanity', 56 TheAir Force Law Review (2005) 168-231.
74. Art.7(1)(k) ICCSt.
75. Judgment, Kvočka and others (IT-98-30/1-T), Trial Chamber, 2 November 2001, § 208. The ICTY Trial Chamber in Kupreškić declared that the category was intended to evade any notion that the list of enumerated crimes against humanity was exhaustive and that '[a]n exhaustive categorization would merely create opportunities for evasion of the letter of the prohibition' (Judgment, Kupreskic and others (IT-95-16-T), Trial Chamber, 14 January 2000, § 563.).
76. Judgment, Krnojelac (IT-97-25-T), Trial Chamber,15 March 2002, §131.
77. Criminal Code of Canada, R.S.C.1985, c. C-46.
78. The Case of the S.S.'Lotus' (France v. Turkey) (1927) PCIJ Ser. A. No. 10, at 19.
79. M.P. Scharf,'Application of Treaty-Based Universal Jurisdiction to Nationals of Non-Party States', 35 New England Law Review (2001) 378-379.
80. See Amnesty International, 'Universal Jurisdiction - the Duty of States to Enact and Enforce Legislation', available at http://web.amnesty.org/pages/legal_memorandum (visited 27 November 2010); L. Reydams, Universal Jurisdiction: International and Municipal Legal Perspectives (Oxford: Oxford University Press, 2003).
81. G. Mullan, 'The Concept of Double Criminality in the Context of Extraterritorial Crimes', Criminal Law Review (1997) 17.
82. The Treaty on Extradition Between the Government of Canada and the Government of the United States of America, CTS 1976 No. 3, states in its Schedule that it applies to extradite persons alleged to have carried out 'any unlawful seizure or exercise of control of an aircraft, by force or violence or threat of force or violence, or by any other form of intimidation, on board such aircraft.'.
83. Criminal Code (Strafgesetzbuch, StGB), 13 November 1998.
84. Program in Law and Public Affairs, Princeton University, The Princeton Principles on Universal Jurisdiction (Princeton: Program in Law and Public Affairs, 2001), at 28.
85. C. Wilke, 'A Particular Universality: Universal Jurisdiction for Crimes Against Humanity in Domestic Courts',12 Constellations (2005) 83-102.
86. Even that, however, did not happen, and SmithKline Beecham was criticized for not taking legal action - even for trademark infringement - so as not to hamper trade relations with Nigeria. See A. Raufu, 'Nigeria leads fight against killer counterfeit drugs', 84 Bulletin of the World Health Organization (2006) 685-764.
87. Editorial,'Fighting Drug Fakes', New York Times (12 December 2006).
88. This is not to say that successful cooperation cannot occur between nations over counterfeit drugs, just that it is rare and not systematic. Nigeria is cooperating with both the Chinese and Indian governments to attempt to bring counterfeiters to book: personal communication by one of the authors (Bate) with Paul Orhii, the Director of the Nigerian anticounterfeit drug agency (NAFDAC), 26 February 2010.
89. See, for example: Universal Declaration of Human Rights, GA Res. 217 A (III), 1948 at Art. 25 which stipulates that '[e]veryone has the right to a standard of living adequate for the health and well-being of himself and of his family, including ... medical care'; International Covenant on Economic, Social and Cultural Rights, GA Res. 2200A (XXI), 1976 at Section 12.2 which enshrines 'the right of everyone to the enjoyment of the highest attainable standard of physical and mental health'. This encapsulates, inter alia, 'the prevention, treatment and control of epidemic ...diseases'and 'the creation of conditions which would assure to all medical service and medical attention in the event of sickness'; Convention on the Rights of the Child, GA Res. 25, 1990 at Section 24.
90. Constitution of theWorld Health Organization,14 UNTS No. 185,7 April1948, at Art.1 (hereafter the 'WHO Constitution').
91. A. Taylor, 'Global Governance, International Health Law and WHO: Looking Towards the Future', 80 Bulletin of World Health Organization (2002) 975.
92. D. Fidler,'The Future of the World Health Organization: What Role for International Law?' 31 Vanderbilt Journal of Transnational Law (1998) 1079.
93. See WHO,'WHO Framework Convention on Tobacco Control', available at http://www.who.int/fctc/text_download/en/index.html (visited 27 November 2010).
94. Draft Protocol to Eliminate Illicit Trade of Tobacco Products, UN Doc. FCTC/COP/INB-IT/4/7, 14-21 March 2010.
95. The only notable difference is that, unlike for medicines, counterfeit tobaccos cannot be blamed for any distinct attack on a civilian population, certainly no more so than legitimate tobaccos which also kill efficiently. Hence it is inappropriate to use the extraordinary doctrines of crimes against humanity or universal jurisdiction to criminalize counterfeit tobacco, since it is tobacco primarily, and counterfeiting only secondarily, which causes harm, and these are not found in the Draft Protocol.
96. International framework convention for tobacco control, UN Doc. WHA 49.17, 25 May 1996.
97. Towards a WHO framework convention on tobacco control, UN Doc. WHA52.18, 24 May 1999.
98. See WHO, 'Working Group preceding the Intergovernmental Negotiating Body on the WHO FCTC (1999-2000)' (WHO), available at http://www.who.int/fctc/about/pre_neg_wor-king_group/en/index.html (visited 27 November 2010); Framework convention on tobacco control, UN Doc.WHA53.16, 20 May 2000.
99. C. Kapp, 'Counterfeit Drug Problem "Underestimated", says Conference', 360 Lancet (2002) 1080.
100. See S. Shashikant, 'Clash over WHO's Role in "Counterfeits", IMPACT', SUNS (25 May 2010) (Third World Network), available at http://www.twnside.org.sg/title2/health.info/2010/health20100505.htm (visited 27 November 2010).
101. See WHO, 'Decisions and List of Resolutions', 63rd World Health Assembly, 8 June 2010, available at http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_DIV3-en.pdf (visited 27 November 2010).