The politics of patents and drugs in Brazil and Mexico: The industrial bases of health policies

Comparative Politics

Volumn 42, Issue 1, 2009, Pages

  Shadlen, Kenneth C ^a  

^a NONE

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EID: 72849128768     PISSN: 00104159     EISSN: None     Source Type: Journal    
DOI: 10.5129/001041509x12911362972791     Document Type: Article

References (91)

1. Until the 1970s many developed countries (for example, Italy and Japan) did not issue pharmaceutical patents either.
2. The term "generic" is used to refer to drugs unprotected by patents. Some definitions also stipulate that the drug be unprotected by trademark. Although generic does not mean the same thing everywhere, Brazilian and Mexican regulations share a common definition. Nuria Homedes and Antonio Ugalde, "Multisource Drug Policies in Latin America: Survey of 10 Countries," Bulletin of the World Health Organization. 83 (January 2005): 64-70.
3. World Health Organization, "Intellectual Property Protection: Impact on Public Health," WHO Drug Information, 19 (August 2005): 236-41;
4. Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy (London: CIPR, 2002), chap. 2;
5. Brigitte Granville, ed., The Economics of Essential Medicines (London: Royal Institute of International Affairs, 2002);
6. Julio Nogués, "Social Costs and Benefits of Introducing Patent Protection for Pharmaceutical Drugs in Developing Countries," The Developing Economies, 31 (March 1993): 24-53.
7. Maria Victoria Murillo, "Political Bias in Policy Convergence: Privatization Choices in Latin America," World Politics, 54 (July 2002): 462-493
8. In fact, Fox's appointment as Health Secretary was well known for his long-standing call for universal health coverage.
9. Special issues dedicated to the theme of policy diffusion oí Annals of the American Academy of Political and Social Sciences, 598 (March 2005) and International Organization, 60 (October 2006).
10. See also, Beth Simmons and Zachary Elkins, "The Globalization of Liberalization: Policy Diffusion in the International Political Economy," American Political Science Review, 98 (February 2004): 171-89;
11. Jeffrey Chwierorth, "Neoliberal Economists and Capital Account Liberalization in Emerging Markets," International Organization, 61 (Spring 2007): 443-63;
12. and Sarah Brooks, "When Does Diffusion Matter? Explaining the Spread of Structural Pension Reforms Across Nations," Journal of Politics, 69 (August 2007): 701-715
13. Amy S. Nunn, Elize M. Fonseca, Francisco I. Bastos, Sofia Gruskin, Joshua A. Salomon, "Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment," PLoS Medicine, 4 (November 2007): 1-13.
14. Jillian Clare Cohen and Kristina M. Lybecker, "AIDS Policy and Pharmaceutical Patents: Brazil's Strategy to Safeguard Public Health," The World Economy 28 (February 2005): 226.
15. For detailed discussion, see Carlos Correa, Integrating Public Health Concerns into Patent Legislation in the Developing Countries (Geneva: South Centre, 2000); CIPR, chap. 2.
16. In fact, some policy areas are relevant to multiple lines of conflict.
17. Countries that did not grant pharmaceutical patents prior to 1995 had until 2005 to begin doing so.
18. In addition to stretching the definition of "novelty," the problem with pipeline patents is that that they are not examined but rather revalidated.
19. Compare the nearly identical CL provisions of TRIPS Article 31 ( http://www.wto.org/english/tratop-e/trips-e/t-agm3c-e.htm#5) and NAFTA Article 1709.10 (http://www.sice.oas.org/Trade/nafta/chap-171.asp).
20. This provision, that when CLs are issued on grounds of national emergency countries are released from procedural obligations, is often misrepresented to suggest that countries can only issue CLs in national emergencies. To repeat, countries can issue CLs on whatever grounds they establish in national legislation, but in times of national emergency (and government use) they can bypass negotiations.
21. Formally, early working (also called "Bolar") provisions are examples of limiting owners' rights of exclusion, but where they most matter regards the effective duration of owners' rights.
22. Such provisions do not shorten patent terms but rather eliminate the effective extension of terms that is yielded by leaving a single firm with market exclusivity despite the patents' expiration. I am not addressing data exclusivity.
23. Guido Carlos Levi and Marco Antonio A. Vitória, "Fighting Against AIDS: The Brazilian Experience," AIDS, 16 (2002): 2373-83;
24. Paulo Texieira et al., "The Brazilian Experience in Providing Universal Access to Antiretroviral Therapy," in Economics of AIDS and Access to HIV Care in Developing Countries, ed. Moatti et al. (Paris: ANRS, 2003): 69-88;
25. Jane Galvão, "Brazil and Access to HIV/AIDS Drugs: A Question of Human Rights and Public Health," American Journal of Public Health, 95 (July 2005): 1110-16;
26. Alexandre Grangeiro et al., "Sustentabilidade da politica de acesso a medicamentos anti-retrovirais no Brasil," Revista de Saúde Pública 40 (Supplement 2006): 60-69;
27. João Biehl, Will to Live: AIDS Therapies and the Politics of Survival (Princeton, NJ: Princeton University Press, 2007);
28. Anne-Christine d'Adesky, Moving Mountains: The Race to Treat Global AIDS (New York: Verso, 2004), chap. 3;
29. Matthew Flynn, "Public Production of Anti-Retroviral Medicines in Brazil, 1990-2007," Development and Change 39 (July 2008): 513-536. Thus, in the context of persistent inequities in health services (Kurt Weyland, Democracy Without Equity: Failures of Reform in Brazil [Pittsburgh: University of Pittsburgh Press, 1996], chap. 7), the National HIV/AIDS Program offers an exception.
30. Levi and Vitória, "Fighting Against AIDS";
31. th Ordinary Meeting of the National Health Council, Brasilia, August 2005. The former Minister of Health also emphasizes that an overvalued currency cheapened drug imports, a situation that changed with the Real's devaluation in 1999. José
32. Serra, "The Political Economy of the Brazilian Struggle Against AIDS," Institute for Advanced Study, Occasional Paper 17, 2004, p. 9.
33. ANVISA's IP division, established in 2001, was housed in INPI's Rio office building.
34. Does showing a "second use" for an existing drug constitute "novelty" and warrant a patent?
35. Maristela Basso, "Intervention of Health Authorities in Patent Examination: The Brazilian Practice of the Prior Consent," International Journal of Intellectual Property Management, 1 (2006): 54-74;
36. and Maristela Basso and Edson Beas Rodrigues, "Direitos de Propriedade Intelectual, Desenvolvimento Humano e Tecnológico Local: Desafios para o Brasil no Cenário pós-TRIPS/OMC," Unpublished UNDP working paper, 2006, Annex 1.
37. This policy corresponds to two types of conflicts, what knowledge can be owned and also the duration of private rights.
38. Helen Miranda Silva, Avaliação da análise dos pedidos de patentes farmacêuticas feita pela Anvisa no cumprimento do mandato legal da anuência prévia. Masters Dissertation, National School of Public Health, 2008. One important hitch with the process is how INPI reacts when ANVISA rejects a patent.
39. See Kenneth C. Shadlen, "The Political Contradictions of Incremental Innovation in Late Development: Lessons from Pharmaceutical Patent Examination in Brazil," unpublished manuscript, London School of Economics, 2009.
40. Although presidential directives are meant to establish implementation guidelines and not formally reform laws, they are often substantive, as in this case.
41. A different article (Art. 68, which authorizes CLs where a patented good is not manufactured locally) was the subject of a WTO case that the United States filed and later withdrew.
42. Rebrip, "Acordo do Governo Brasileiro com a Abbot Frustra Expectativas dos Brasileiros," 13 July 2005 (http://www.rebrip.org.br/- rebrip/pagina.php?id=659);
43. Grangeiro et al., "Sustenabilidade."
44. See the comments of Pedro Chequer, former director of the National HIV/AIDS Program, in Jon Cohen, "Brazil: Ten Years After," Science, 313 (28 July 2006): 484-487
45. Nunn et al., "Antiretroviral Drug Costs";
46. Cohen and Lybecker, "AIDS Policy";
47. Galvão, "Brazil and Access";
48. Cohen, "Brazil: Ten Years After."
49. Nunn et al., "Antiretroviral Drug Costs."
50. Introduced by presidential decree, then converted into law in 2001.
51. "Patent Term Extensions in Mexico Buck Latin American Trend," Global Insight, 2 January 2008 (http://ww.globalinsight.com/SDA/SDADetail 1 1297.htm).
52. These complaints and accusations were repeated in multiple interviews with representatives from INTERFARMA, patent lawyers in Brazil, and USTR officials. See, as examples, Frederico Vasconcelos, "Mudanças na lei desagradam múltis," Folha de São Paulo, 21 February 2000;
53. Lawrence A. Kogan, "Brazil's IP Opportunism Threatens U.S. Private Property Rights," Inter-American Law Review, 38 (Fall 2006): 1-139;
54. and Igor Leonardo Guimarães Simões, "A Guerra das patentes farmacêuticas," Jus Navigandi, 9 (28 May 2005).
55. See also the USTR's annual "Special 301" reports on IP, and PHARMA's submissions to these reports.
56. See, for example, Vasconcelos, "Mudanças na lei desagradam múltis";
57. Marcos Oliveira, "A falácia da quebra de patente," Jornal do Commercio, 10 April 2006 (column by ABIFINA's vice-president published in newspapers throughout Brazil);
58. and Eduardo Costa and Nelson Brasil, "A Emancipação do Programa antiAids," Jornal de Brasilia, 15 November 2007. Brazilian industry's position is not uniform, of course, nor its support rock-solid. On some issues, particularly those affecting patenting of incremental innovations, local firms are ambivalent and divided. Shadlen, "Political Contradictions of Incremental Innovation."
59. Of Brazil's eighteen government-linked pharmaceutical producers, the most important is part of the MH: Farmanguinhos, in Rio de Janeiro. Public sector labs mostly engage in formulation of final dosages, and to a lesser degree on pharmochemical inputs. Flynn, "Public Production."
60. Maurice Cassier and Marilena Correa, "Intellectual Property and Public Health: Copying of HIV/Aids Drugs by Brazilian Public and Private Pharmaceutical Laboratories, RECIIS Eletronical Journal in Communication, Information and Innovation in Health, 1 (January 2007): 84.
61. See also, Claudia Chamas, "Developing Innovative Capacity in Brazil to Meet Health Needs," World Health Organization, Commission on Intellectual Property Rights, Innovation and Public Health, 2005;
62. and Eduardo Costa, "Politica de medicamentos: tecnologia e produção no país," ABIFINA Informa, No. 216, March 2006.
63. Confidential interview, 18 May 2008 (Rio de Janeiro). For further illustration of this collaboration, see Cassier and Correa, "Intellectual Property and Public Health";
64. Costa and Brasil, "A emancipação."
65. IMS and MH data; Chamas, "Developing Innovative Capacity."
66. Sérgio Queiroz, "La Industria Farmacéutica y Farmoqulmica Brasileña en los Años 90," in Jorge Katz et al., Apertura Económica y Desregulación en el Mercado de Medicamentos (Buenos Aires: Alianza Editorial, 1997), 125-65;
67. José Eduardo Cassiolato et al., "Avaliação Econômica da Capacidade do Brasil para a Fabricação dos Medicamentos para HIV/AIDS," Unpublished UNDP working paper, 2006;
68. Joseph M. Fortunak and O.A.C. Antunes, ARVs Production in Brazil: An Evaluation (Rio de Janeiro: Associação Brasileira Interdisciplinar de AIDS, 2006);
69. and Lélio A. Maçaira, "A Capacitação Productiva Brasileira para AntiRetrovirais," ABIFINA Informa 216, March 2006.
70. Introducing pharmaceutical patents in 1997 is still early, since Brazil had until 2005.
71. Patricia Uribe Zúñiga et al., "AIDS in Mexico," The Body, November 1998;
72. d'Adesky, Moving Mountains, chap. 7;
73. Sergio Bautista et al., "Antiretroviral Treatment Costs in Mexico," WHO/UNAIDS Workshop on Strategic Information for Anti-Retro viral Therapy Programmes, June 2003.
74. Bioequivalent medicines feature the same APIs as reference drugs, and they perform identically in the human body. "Similars" may not satisfy the second criterion.
75. For analysis of Farmacias Similares and the Dr. Simi phenomenon, see Cori Hayden, "A Generic Solution? Pharmaceuticals and the Politics of the Similar in Mexico," Current Anthropology, 48 (August 2007): 475-495
76. Interview, former President of CCyT, 10 August 2007 (Mexico City).
77. Interview, Director General of AMIIF, 14 August 2007 (Mexico City).
78. CCyT archives; interview, former official in Secretary of Government, 14 August 2007 (Mexico City).
79. As an illustration of the perversity of this legislative process, note that the original sponsors of the initiative to reform Mexico's CL system (PVEM) ended up actively opposing the final bill that was passed in Congress.
80. "Patent Term Extensions in Mexico Buck Latin American Trend."
81. Gary Gereffi, The Pharmaceutical Industry and Dependency in the Third World (Princeton, NJ: Princeton University Press, 1983);
82. Joan Brodovsky, "Industria farmacéutica y farmoquímica mexicana en el marco regulatorio de los años noventa," in Katz et al., Apertura Económica, 167-199
83. CEPAL, "Las Industrias Farmacéutica y Farmoqulmica en México y el Distrito Federal," LC/ MEXL.400, 1999, p. 49;
84. María Fabiana Jorge, "Efectos de la Globalización en la Industria Farmacéutica en México," in ANAFAM, La Industria Farmacéutica Mexicana (México, D.F.: Editorial Porrúa, 2006).
85. Kenneth C. Shadlen, "Orphaned by Democracy: Small Industry in Contemporary Mexico," Comparative Politics 35 (October 2002): 43-62.
86. The leading generics firms in Mexico are Israeli, British, French, and Canadian.
87. CCyT archives, letter on file with author; interview, ex-President of ANAFAM, 21 August 2007 (Mexico City).
88. Space prevents discussion of data exclusivity, but the same pattern prevails.
89. Although neither restrictions on CLs nor the type of linkage introduced in Mexico are required by NAFTA, both sorts of provisions feature in many recent RBTAs.
90. Gereffi, Pharmaceutical Industry,
91. Daniel Chudnovski, "The Challenge by Domestic Enterprises to the Transnational Corporations' Domination: A Case Study of the Argentinean Pharmaceutical Industry" World Development, 7 (January 1979): 45-58.