A one-time-only combination: Emergency medicine exports under canada's access to medicines regime

Health and Human Rights

Volumn 12, Issue 1, 2010, Pages 109-122

  Weber, Ashley ^a   Mills, Lisa ^b  

^a Stikeman Elliott   (Canada)

^b CARLETON UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; GENERIC DRUG; PRESCRIPTION DRUG;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; DEVELOPING WORLD; EXPORT; HEALTH POLICY; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN RIGHTS; MEDICINE; PHARMACEUTICAL INDUSTRY;

ARTICLE; CANADA; DEVELOPING COUNTRY; DRUG INDUSTRY; ECONOMICS; HEALTH CARE DELIVERY; HEALTH SERVICE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTERNATIONAL COOPERATION; LEGAL ASPECT; PATENT; RWANDA; STATISTICS;

ANTI-HIV AGENTS; CANADA; DEVELOPING COUNTRIES; DRUG INDUSTRY; DRUGS, GENERIC; HEALTH SERVICES ACCESSIBILITY; HEALTH SERVICES NEEDS AND DEMAND; HIV INFECTIONS; HUMANS; INTELLECTUAL PROPERTY; INTERNATIONAL COOPERATION; PRESCRIPTION DRUGS; RWANDA;

CANADA;

EID: 77957079146     PISSN: 10790969     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (75)

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20. Klug (see note 14).
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23. Agreement on trade-related aspects of intellectual property rights (TRIPS), Annex 1C of the Marrakesh Agreement establishing the World Trade Organization, Article 27 (1994), pp. 331-332. Available at http://www.wto.org/english/docs_e/legal_e/27-trips.pdf.
24. TRIPS (see note 25), Article 7, p. 323.
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26. S. K. Sell, Private power, public law: The globalization of intellectual property rights (New York: Cambridge University Press, 2003), p. 13.
27. TRIPS (see note 25), Article 8(1), p. 323. See also P. L. Osewe, Y. K. Nkrumah, and E. K. Sackey, Improved access to HIV/AIDS medicines in Africa: Traderelated aspects of intellectual property rights flexibilities (Washington, DC: World Bank, 2008).
28. TRIPS (see note 25), Article 30, p. 332.
29. TRIPS (see note 25), Article 31, pp. 333-334.
30. Klug (see note 14). Article 27 of the TRIPS Agreement requires members to protect patents in all fields of technology, thereby excluding the possibility of treating medicines differently from other types of innovation.
31. WHO (see note 13).
32. Office of the United States Trade Representative, 2009 Special 301 Report (Washington, DC: United States Trade Representative, April 30, 2009), p. 8. Available at http://www.ustr.gov/sites/ default/files/Full%20Version%20of%20the%20 2009%20SPECIAL%20301%20REPORT.pdf.
33. E. t'Hoen, "Public health and international law: TRIPS, pharmaceutical patents, and access to essential medicines: A long way from Seattle to Doha," Chicago Journal of International Law 3/1(2002), pp. 27-46.
34. Klug (see note 14).
35. t'Hoen (see note 33); President of the United States, Executive Order 13155, Access to HIV/ AIDS Pharmaceutical and Medical Technologies.
36. A. Harmon and R. Pear, "Canada overrides patent for Cipro to treat anthrax," New York Times (October 19, 2001). Available at http://www. nytimes.com/2001/10/19/business/19CANA. html?pagewanted=1.
37. Although the US action with regard to ciprofloxacin undermined US moral authority and facilitated the creation of the Doha Declaration, the US has nevertheless continued to promote and implement policies that restrict access to generic medicines. See, for example, S. M. Fiil Flynn, "Special 301 in the Obama Administration: The Assault on International Generic Medicines Continues" (Washington, DC: American University, Washington College of Law, Program on Information Justiceand Intellectual Property, 2010). Available at wcl. american.edu/pijip/go/flynn04132010.
38. Osewe et al. (see note 23).
39. F. M. Abbott, "The WTO medicines decision; World pharmaceutical trade and the protection of public health," American Journal of International Law 99/2 (2005), pp. 317-358. Because paragraph six of the decision addressed this dilemma, it is sometimes also referred to as the "Paragraph Six Decision."
40. Article 2(a) Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health.
41. Specifically, it withdrew the heat stable form of Liponavir/Ritonavir from the registration process in Thailand. See also N. Wong-Anan, "Thailand will override cancer drug patents" [press release], Reuters (March 10, 2008).
42. Office of the United States Trade Representative (see note 33), p. 21.
43. See R. Smith, C. Correa, and C. Oh, "Trade, TRIPS, and pharmaceuticals," Lancet 373/9664 (2009), pp. 684-691.
44. Klug (see note 14).
45. B. Doern and M. Sharaput, Canadian intellectual property: The politics of innovating institutions and interests (Toronto: University of Toronto Press, 2000).
46. Ibid.
47. R. Elliott, "Will they deliver treatment access? WTO rules and Canada's law on generic medicine exports," HIV/AIDS Policy and Law Review 11/2/3 (2006), pp. 13-16. Bill C-56 included a "first opportunity" clause for patentees, which subsequently became known in the media as the "right of first refusal." Under this clause, generic companies would have to disclose the details of any contract being negotiated that pertained to patented drugs. This clause would have given brand-name companies the right to fill contracts negotiated by generic companies, as well as an incentive to underbid prices offered by the generic companies in order to prevent them from entering the market. With no guarantees or consistent market access, there wouldhave been little incentive for generic companies to engage in negotiations and increase competition in drug prices. The clause was ultimately removed from the legislation after intensive lobbying by NGOs. See L. Mills and A. Weber, "Access to emergency medicines: How Ottawa amends the Patent Act," in Bruce Doern (ed), How Ottawa spends 2006-2007: In from the cold - the Tory rise and the Liberal demise (Montreal: McGill-Queen's University Press, 2006), pp. 229-246.
48. Data in what follows is based on confidential interviews with representatives from the government, NGOs, the brand-name and generic pharmaceutical industry, and media representatives. Interviews were conducted in February 2005, September 2007, and January 2008.
49. Osewe et al. (see note 23).
50. This concept is explained as follows: "Under CAMR, the remuneration, or royalty fee, to be paid by the licencee to the patentee is calculated by multiplying the monetary value of the supply contract by an amount that fluctuates on the basis of the importing country's standing on the UN Human Development Index. According to this formula, the lowest country on the index would pay a royalty of approximately 0.02 percent, and the highest 3.5 percent." Government of Canada, "Canada's Access to Medicines Regime - Consultation Paper" (November 24, 2006). Available at http://www. camr-rcam.gc.ca/review-reviser/camr_rcam_ consult_e.html.
51. Interview with a representative of brand-name pharmaceutical firms, February 2005.
52. Interview with an Apotex representative, November 8, 2007.
53. Parliament of Canada, House of Commons Standing Committee on Industry, Science and Technology, Minutes of Proceedings, Meeting No. 55 (April 23, 2007), statement by Jack Kay.
54. Parliament of Canada (see note 54), statement by Gregg Alton.
55. Parliament of Canada, House of Commons Standing Committee on Industry, Science and Technology, Minutes of Proceedings, Meeting No. 54 (April 18, 2007), statement by Sarah Perkins.
56. Government of Canada, "Consultation paper" (see note 51).
57. Parliament of Canada (see note 54), statement by Brian Masse. 60. Parliament of Canada (see note 54).
58. Government of Canada (see note 57).
59. The North-South Institute and Canadian HIV/ AIDS Legal Network, Access to medicines and intellectual property: An international expert meeting on Canada's Access to Medicines Regime, global developments, and new strategies for improving access, Meeting Report (Ottawa: April 19-21, 2007).
60. TRIPS (see note 25), Article 30, p. 332.
61. Interview with a NGO representative, September 13, 2007.
62. Interview with a Government Representative, September 13, 2007.
63. Campaign for Access to Essential Medicines, Médecins Sans Frontières, Neither expeditious, nor a solution: The WTO August 30th decision is unworkable (Geneva: Médecins Sans Frontières, 2006). Available at http://www.msf.ch/fileadmin/user_upload/ uploads/communiques/images_2006/pdf/came_ Neither_expeditious_nor_a_solution_-_August_30_ and_the_JCPA_single_page.pdf.
64. M. Rimmer, "Race against time: The export of essential medicines to Rwanda," Public Health Ethics, 1/2 (2008), pp. 89-103.
65. Interview with an Apotex representative (see note 53).
66. Ibid.
67. Ibid.
68. Ibid.
69. Interview with a NGO representative (see note 63).
70. Interview with an Apotex representative (see note 53).
71. Rimmer (see note 4).
72. Interview with an Apotex representative (see note 53).
73. Ibid.
74. Interview with a Canadian Generic Pharmaceutical Association representative, September 12, 2007.
75. Médicins Sans Frontières,"MSF calls