Abstract
In recent years, intellectual property rights protections have increased in Central America. Transnational access to medicines campaigns focused particular attention on the public health implications of these protections in the context of debates around the ratification of the US-Central America Free Trade Agreement (CAFTA), but these efforts did not lead to long-term engagement with intellectual property and access questions by local health activists. This paper explores differences in priority focus between global access to medicines movement and local health activists in Central America, arguing that transnational access advocates’ core arguments rely on assumptions that mesh poorly with on-the-ground realities in Central America. I examine differences in drug markets and political alliances, suggesting that these factors help explain the imperfect connection between global access to medicines frames and the needs of patients and advocates in Central America.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
Notes
Many of the dynamics mentioned in this article are explored in greater depth in my recent book Of Medicines and Markets: Intellectual Property and Human Rights in the Free Trade Era (2013), which includes extensive discussions of interviews which are only summarized here, due to limitations of scope and space. My perspective on these issues is also informed by my own participation as an opponent of CAFTA’s IP provisions in many discussions in the United States over this period and my experience directing a network of Central American researchers monitoring the impacts of new IP rules in their countries.
Test data protection differs from patents in important ways. While test data protection is in force, generic drugmakers are barred from registering their drugs by demonstrating equivalency to a product already shown to be safe, in this sense proving the safety of their drug by “piggybacking” on the clinical test data produced by the originator company. What’s protected, in this sense, is the test data. Although theoretically a generic company could enter the market if able to produce its own clinical test data, in practice it would be prohibitively expensive for generic manufacturers to replicate clinical trials, so test data protection, like a patent, produces a temporary monopoly. What makes test data protection so significant, however, is the fact that unlike a patent, it is granted automatically to the first registrant of any drug at the time of market entry. Patents, on the other hand, require significant investment on the part of the patent seeker; they are granted by national, not international, authorities, so patents must be sought separately before the authorities in each country, and procedures and standards vary from country to country. Typically, patent law requires demonstration that the substance is new, non-obvious, and useful; patents can be challenged by third parties, and can be revoked if it is shown that the product does not fulfill these criteria.
MSF’s departure was not motivated by CAFTA’s ratification, for MSF’s activities in country were much broader in scope than simply opposing the agreement. Rather, because MSF aims to avoid substituting for the state in delivering health services, its prior agreement with the Guatemalan government stipulated a 2005 departure, at which point the state would assume responsibility for the programs MSF had spearheaded. Whatever the reason, however, it coincided in time with the agreement’s passage, leading to a precipitous drop-off in civil society organizing around IP following ratification.
Recognizing the importance of informing national implementation processes, UNCTAD and ICTSD commissioned a dialog with Argentine IP expert Carlos Correa in which he instructed Central American countries how to implement test data protection to conform with CAFTA’s requirements while preserving as much latitude as possible for public health considerations. To guide these discussions, Correa drafted a “Model Law” for CAFTA implementation (Correa 2006a, b).
This is not intended to imply that access advocates are unaware of the need for other reforms in Central America; MSF, a leading force in the coalition against CAFTA in Guatemala, was at the time very significant player working to improve delivery of health care by the Guatemalan state along many fronts other than IP. But their campaigning around IP was not directly connected to these efforts in ways that were explicit and publicly visible.
For example, in the US market, at least two studies have shown an inverse relationship between the number of drugs competing in the market and the average price: see Congressional Budget Office (1998) and Caves et al. 1991. But the number of competing drugs matters: see Frank and Salkever (1997). As Reiffen and Ward write, “Generic drug prices fall with increasing number of competitors, but remain above long-run marginal cost until there are eight or more competitors.” (Reiffen and Ward 2006: 37–49).
Significantly, Rodríguez later returned to El Salvador, becoming the first female rector of the University of El Salvador, and as of this writing, serves as Minister of Health; her influence looms large in progressive health circles in El Salvador.
Since Central American countries’ production capacity is limited for the most technologically advanced drugs, this is not an insignificant benefit.
References
Asamblea Legislativa de la República de Costa Rica. Ley De Informacion no Divulgada, Public Law 7975. http://ministeriopublico.poder-judicial.go.cr/coop-intern/Normativa%20Nacional/10-Propiedad%20Intelectual/08.pdf (2000). Accessed 29 July 2011.
Ayala V, Humberto C. Consecuencias jurídicas en materia de la ley de propiedad intelectual sobre comercialización y distribución de medicamentos genéricos frente a la ratificación del DR-CAFTA por parte de guatemala. Licenciado en Ciencias Jurídicas y Sociales. Universidad de San Carlos de Guatemala, Facultad de Ciencias Jurídicas y Sociales; 2006.
Bogo J. Análisis desde el punto de vista de la defensa de la competencia de los mercados de medicamentos para el tratamiento de las enfermedades cardiovasculares, respiratorias y gastrointestinales en El Salvador. informe de resultados. San Salvador: Superintendencia de Competencia, República de El Salvador. http://www.sc.gob.sv/pages.php?Id=206 (2007). Accessed 30 July 2011.
Caves RE, Whinston ME, Hurwitz MA. Patent expiration, entry, and competition in the US pharmaceutical industry: an exploratory analysis, Brookings papers on economic activity: microeconomics. Washington, DC: Brookings Institute; 1991. p. 1–66.
Center for Pharmaceutical Management. Access to essential medicines: El Salvador. 2001. Arlington: Management Sciences for Health; 2003.
Ceron A, Godoy AS. Intellectual property and access to medicines: an analysis of legislation in Central America. Bull World Health Organ. 2009;87(1):787.
Congressional Budget Office. How increased competition from generic drugs has affected prices and returns in the pharmaceutical industry. Washington, DC: United States Congressional Budget Office; 1998.
Congreso de la República de Guatemala. Decreto 30-2005. http://www.oj.gob.gt/es/QueEsOJ/EstructuraOJ/UnidadesAdministrativas/CentroAnalisisDocumentacionJudicial/cds/CDs%20leyes/2005/pdfs/decretos/D030-2005.pdf (2005). Accessed 4 May 2015.
ConSuAccion (Consumidores en Acción de Centroamérica). Promoción etica y precio justo en los medicamentos? una mirada desde las organizaciones de consumidores en centroamérica. San Salvador: ConSuAcción (Consumidores en Acción de Centroamérica; 2007.
Correa C. Implementación de la protección de datos de prueba de productos farmacéuticos y agroquímicos en DR-CAFTA-ley modelo. Geneva: International Centre for Trade and Sustainable Development (ICTSD); 2006a.
Correa C. Implications of bilateral free trade agreements on access to medicines. Bull World Health Organ. 2006b;84(5):399.
Donahue J M. International organizations, health services, and nation building in Nicaragua. Medical Anthropology Quarterly 3 (3, The Political Economy of Primary Health Care in Costa Rica, Guatemala, Nicaragua, and El Salvador): pp. 258–69. http://www.jstor.org/stable/648642 (1989).
Drahos P. Four lessons for developing countries from the trade negotiations over access to medicines. Liverpool Law Rev. 2007;28:11.
Espinoza F E, Giovanni G. Disponibilidad y precio de los medicamentos en el salvador durante el segundo semestre de 2006. San Salvador: Universidad de El Salvador; 2007.
Espinoza F E, Maria Angela Marroquín Elías, and Giovanni Guevara. Caracterización del Sector Farmacéutico Nacional. El Salvador 2009. San Salvador: Observatorio de Políticas Públicas y Salud, Universidad de El Salvador; 2009.
Frank R G, Salkever David S. Generic entry and the pricing of pharmaceuticals. National Bureau of Economic Research Working Paper Series Vol. w5306 1997.
Godoy AS. Of medicines and markets: intellectual property and human rights in the free trade era. Palo Alto: Stanford University Press; 2013.
Godoy AS, Cerón A. Changing drug markets under new intellectual property regimes: the view from Central America. Am J Public Health. 2011;101(7):1186.
Goodman Z. Costa Rica: Fortalecimiento de las leyes de patentes, debilitamiento de los derechos humanos. presentación ante el comité de derechos económicos, sociales y culturales. Geneva: 3D, www.3dthree.org/pdf_3D/3DCDESC_CostaRica.pdf (2007). Accessed 31 July 2011.
Green L B. Consensus and coercion: Primary health care and the Guatemalan state. Medical Anthropology Quarterly 3 (3, The political economy of primary health care in Costa Rica, Guatemala, Nicaragua, and El Salvador): pp. 246–57. http://www.jstor.org/stable/648641(1989).
Hayden C. A generic solution? Pharmaceuticals and the politics of the similar in Mexico. Curr Anthropol. 2007;48(4):475–95. doi:10.1086/518301.
Health GAP. Transcript: CAFTA and access to essential medicines, July 21, 2005 Teleconference, www.healthgap.org/camp/trade_docs/transcript.doc (2005). Accessed 31 July 2011.
Hogerzeil HV, Samson M, Casanovas JV, Rahmani-Ocora L. Is access to essential medicines as part of the fulfilment of the right to health enforceable through the courts? The Lancet. 2006;368(9532):305.
Hudson J. Generic take-up in the pharmaceutical market following patent expiry: a multi-country study. Int Rev Law Econ. 2000;20(2):205–21.
Hurwitz MA, Caves RE, Harvard Institute of Economic Research. Persuasion or information? Promotion and the shares of brand-name and generic pharmaceuticals. Cambridge: Harvard Institute of Economic Research; 1986.
Kanavos P, Costa-Font J, Seeley E. Competition in off-patent drug markets: issues, regulation and evidence. Econ Policy. 2008;23(55):499–544.
Kapcyzinski A. Harmonization and its Discontents: a case study of TRIPS implementation in India’s pharmaceutical sector, Calif L Rev. 2009;97:1571
Kroeger A, Ochoa H, Arana B, Diaz A, Rizzo N, Flores W. Inadequate drug advice in the pharmacies of Guatemala and Mexico: the scale of the problem and explanatory factors. Ann Trop Med Parasitol. 2001;95(6):605–16.
Martínez GE, Castro Bonilla A. Propiedad intelectual y acceso a medicamentos esenciales de calidad en Centroamérica. San Salvador: FUNDE; 2008.
Morales L. Educación, salud y tierra: tres propuestas ante los modelos impulsados por las instituciones financieras internacionales. Portadores De Sueños: Pensamiento y Acción En Salud. 2004;3(9):7.
Morgan LM. International politics and primary health care in Costa Rica. Soc Sci Med. 1990;30(2):211–9.
Morton S, Fiona M. Barriers to entry, brand advertising, and generic entry in the US pharmaceutical industry. Int J Ind Organ. 2000;18(7):1085–104.
Moss GD. Pharmaceuticals—where’s the brand logic?: branding lessons and strategies. Binghamton: Haworth Press; 2007.
Palmer S. Esbozo histórico de la medicina estatal en América Central. Dynamis. 2005;25:59.
Reiffen D, Ward MR. Generic drug industry dynamics. Rev Econ Stat. 2006;87(1):37–49.
Rodríguez-Garavito C, Dreyfuss R, editors. Balancing wealth and health: the battle over intellectual property and access to health in Latin America. Oxford: Oxford University Press; 2014.
Romero J, Muñoz E, Vidal C. Evolution of teaching of preventive and social medicine in Latin America. Revista Médica De Chile. 1975;103(9):628–33.
Sell S K. Private power, public law: The globalization of intellectual property rights. Cambridge studies in international relations. Vol. 88. Cambridge: Cambridge University Press, http://www.loc.gov/catdir/description/cam031/2002035020.html; http://www.loc.gov/catdir/toc/cam031/2002035020.html (2003).
Sell S K. The global IP upward ratchet, anti-counterfeiting and piracy enforcement efforts: The state of play. PIJIP Research Paper no. 15. (2010) Accessed 27 July 2011.
Smith-Nonini SC. “Popular” health and the state: dialectics of the peace process in El Salvador. Soc Sci Med. 1997;44(5):635–45.
Smith-Nonini SC. Healing the body politic: El Salvador’s popular struggle for health rights—from civil war to neoliberal peace. Studies in medical anthropology. New Brunswick: Rutgers University Press; 2010.
Tajer D. Latin American social medicine: roots, development during the 1990s, and current challenges. Am J Public Health. 2003;93(12):2023–7.
Waitzkin H, Iriart C, Estrada A, Lamadrid S. Social medicine in Latin America: productivity and dangers facing the major national groups. Lancet. 2001a;358(9278):315–23.
Waitzkin H, Iriart C, Estrada A, Lamadrid S. Social medicine then and now: lessons from Latin America. Am J Public Health. 2001b;91(10):1592–601.
World Health Organization. WHO statistical information system, in World Health Organization [database online]. Geneva: WHO; 2010.
Acknowledgments
The author would like to gratefully acknowledge the contributions of many people to this article. First and foremost, I am grateful for the generosity of my informants in Central America, who include doctors, generics manufacturers, health advocates, patients, and politicians. I also appreciate the thoughtful comments made by the participants in the January 23–25, 2013 conference at Brown University, especially Nitsan Chorev, Peter Evans, and Ken Shadlen. I am also grateful for the insights shared by two anonymous SCID reviewers. While their suggestions were enormously helpful, the responsibility for any remaining omissions or errors in this paper resides solely with the author.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Godoy, A.S. Market Myths and Assumptions: Examining the Transnational Politics of Access to Medicines Campaigning in Central America. St Comp Int Dev 50, 187–202 (2015). https://doi.org/10.1007/s12116-015-9184-4
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12116-015-9184-4