Hostname: page-component-745bb68f8f-v2bm5 Total loading time: 0 Render date: 2025-02-11T07:57:07.600Z Has data issue: false hasContentIssue false
  • English
  • Français

On the Judicialization of Health and Access to Medicines in Latin America

Published online by Cambridge University Press:  29 December 2023

Roberto Iunes  and
Augusto Afonso Guerra Junior
Roberto Iunes
Affiliation:
WORLD BANK, WASHINGTON, DC, USA
Augusto Afonso Guerra Junior
Affiliation:
FEDERAL UNIVERSITY OF MINAS GERAIS, BRAZIL
Get access Rights & Permissions [Opens in a new window]

Abstract

In a context of rapid technological innovation and expensive new products, the paper calls for the generation of real-world data to inform decision-making and an international discussion on the affordability of new medicines, particularly for low- and middle-income countries. Without these, the challenges of health judicialization will continue to grow.

Keywords

Health JudicializationAccess To MedicinesLatin AmericaReal-World Data
Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 51 , Issue S1: Rethinking Pharmaceutical Policies in Latin America and the Caribbean , Fall 2023 , pp. 92 - 99
Copyright
© 2023 The Author(s)

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Andia, T.S. and Lamprea, E., “Is the Judicialization of Health Care Bad for Equity? A Scoping Review,” International Journal for Equity in Health 18 (2019): 61.CrossRefGoogle ScholarPubMed
Reis, B., Borin, M., Da Costa, M., Dresch, R., Firmo, O., Guimarães, M., and Guerra, A., “A Strategy to Improve Knowledge about Health Policies and Evidence Based Medicine for Federal Magistrates in Health Litigation,” Journal of Law, Medicine & Ethics 50, no. 4 (2022): 807–817.CrossRefGoogle ScholarPubMed
R.C.R.M. Nascimento, Judicialização da Assistência Farmacêutica em Minas Gerais — Uma Análise da Correlação entre Proteção aos Direitos de Propriedade Intelectual e o Perfil das Demandas por Medicamentos Atendidas pela Secretaria de Estado da Saúde no Ano de 2010, Dissertação (mestrado), Universidade Federal de Minas Gerais, Instituto de Ciências Biológicas (2012).Google Scholar
For Brazil, Costa Rica, South Africa, and India: O. Mæstad, L. Rakner, and O.L. Ferraz, “Evaluación del Impacto de la Litigación en el Terreno de los Derechos de la Salud: Análisis Comparativo de Argentina, Brasil, Colombia, Costa Rica, India y Sudáfrica,” in La Lucha por los Derechos de la Salud: ¿Puede la Justicia ser una Herramienta de Cambio?, eds. A. E. Yamin and S. Gloppen (2013): 327–360. Buenos Aires: Siglo Veintiuno Editores Argentina. For Colombia, data for 2000-2009 from Ministerio de Salud y Protección Social (2022), Informe Anual Acciones de Tutela en Salud - Vigencia 2021, Orden 30 de la Sentencia T-760 de 2008, Bogotá, Colombia.Google Scholar
Ministerio de Salud y Protección Social, “Informe Anual Acciones de Tutela en Salud - Vigencia 2021, Orden 30 de la Sentencia T-760 de 2008,” 2022, Bogotá, Colombia.Google Scholar
Instituto de Ensino e Pesquisa — INSPER (2019), Judicialização da Saúde no Brasil: Perfil das Demandas, Causas e Propostas de Solução, Conselho Nacional de Justiça.Google Scholar
La Diaria, “Tabaré-Vazquez Elaborará una Propuesta sobre Medicamentos de Alto Precio como Insumo para el Próximo-Gobierno,”2019, available at <https://ladiaria.com.uy/salud/articulo/2019/12/tabare-vazquez-elaborara-una-propuesta-sobre-medicamentos-de-alto-precio-como-insumo-para-el-proximo-gobierno/> (last visited September 18, 2023); Ministerio de Salud Pública, “Judicialización de Procedimientos de Diagnóstico y Terapéuticos a Brindar por el Fondo Nacional de Recursos y su Impacto a Nivel País,” 2019, Presentación a la Mesa de Diálogo, Montevideo, Uruguay.+(last+visited+September+18,+2023);+Ministerio+de+Salud+Pública,+“Judicialización+de+Procedimientos+de+Diagnóstico+y+Terapéuticos+a+Brindar+por+el+Fondo+Nacional+de+Recursos+y+su+Impacto+a+Nivel+País,”+2019,+Presentación+a+la+Mesa+de+Diálogo,+Montevideo,+Uruguay.>Google Scholar
Caja Costarricense de Seguro Social, Judicialización de Medicamentos en la CCSS y Acceso a Medicamentos de Alto Costo, Power Point presentation, November 2022.Google Scholar
Abramovich, V. and Pautassi, L., Health and Human Rights Journal 10, no. 2 (2008).Google Scholar
Between 1970 and 2019, the proportion of the elderly population of Latin America and the Caribbean (those 60 years of age or older) more than doubled: from approximately 5.8% to 12.8% (UN Population Prospects, 2022). The overall prevalence of non-communicable diseases tends to increase overtime, together with this greater participation of older population groups in the total population, as the prevalence of non-communicable diseases is greater in these population groups.Google Scholar
Garcia, M.M., Azevedo, P.S., Mirelman, A., Safatle, L.P., Iunes, R., Bennie, M.C., Godman, B., and Junior, A.A. Guerra, “Funding and Service Organization to Achieve Universal Health Coverage for Medicines: An Economic Evaluation of the Best Investment and Service Organization for the Brazilian Scenario,” Frontiers in Pharmacology 11 (2020): 370.Google ScholarPubMed
Guerra Júnior, A.F., Acúrcio, F.A., Gomes, C.A.P., Miralles, M., Girardi, S.N., and Werneck, G.A.F., et al., “Disponibilidade de medicamentos essenciais em duas regiões de Minas Gerais, Brasil,” Revista Panamericana de Salud Publica 15, no. 3 (2004): 168–175; R.C.R.M.D. Nascimento, J. Álvares, A.A. Guerra Junior, I.C. Gomes, E.A. Costa, S.N. Leite, K.S. Costa, O.M. Soeiro, I.A. Guibu, M.G.O. Karnikowski, F.A. Acurcio, “Availability of Essential Medicines in Primary Health Care of the Brazilian Unified Health System,” Revista de Saude Publica 13, no. 51 (suppl. 2) (2017): 10s.Google Scholar
Freiberg, A. and Espin, J., “Towards a Taxonomy of Judicialisation for Access to Medicines in Latin America,” Global Public Health 17, no. 6 (2022): 912–925.CrossRefGoogle ScholarPubMed
Ministerio de Salud y Protección Social, Informe Anual Acciones de Tutela en Salud - Vigencia 2021, Orden 30 de la Sentencia T-760 de 2008, Bogotá, Colombia, 2022.Google Scholar
Instituto de Ensino e Pesquisa — INSPER (2019), Judicialização da Saúde no Brasil: Perfil das Demandas, Causas e Propostas de Solução, Conselho Nacional de Justiça, 2019.Google Scholar
Machado, M.A.A., et al., “Judicialização do acesso a medicamentos no estado de Minas Gerais, Brasil,” Revista de Saúde Pública São Paulo 45, no. 3 (2011): 590–598. In this paper, we’re using the terms essential list or coverage list interchangeably to refer to those medicines that the government has explicitly defined as necessary or critical for the care of its population and, as such, has committed to make them available. These medicines are also referred as “listed” medicines throughout the text.Google Scholar
Defensoría del Pueblo, Informe 2016-2017, Bogotá, Colombia, DC (2018).Google Scholar
Campbell, E.G., Rao, S.R., DesRoches, C.M., et al., “Physician Professionalism and Changes in Physician-Industry Relationships from 2004 to 2009,” Archives of Internal Medicine 170, no. 20 (2010): 1820–1826.CrossRefGoogle ScholarPubMed
Prosser, H., Almond, S., and Walley, T., “Influences on GPs’ Decision to Prescribe New Drugs—The Importance of Who Says What” Family Practice 20, no. 1 (2003): 61–68. Other examples of recent publications include: M.A. Erdek, “What Clinicians and Health Professions Students Should Learn About How Pharmaceutical Marketing Influences Opioid Prescribing and Patient Outcomes,” AMA Journal of Ethics 22, no. 8 (2020): E681-686; F. Fickweiler and W. Fickweiler, and E. Urbach, “Interactions between Physicians and the Pharmaceutical Industry Generally and Sales Representatives Specifically and Their Association with Physicians’ Attitudes and Prescribing Habits: A Systematic Review,” BMJ Open 7 (2017): e016408; A. Fugh-Berman and N. Homedes, “How Drug Companies Manipulate Prescribing Behavior,” Colombian Journal of Anesthesiology 46 (2018): 317-321; M. Khazzaka, “Pharmaceutical Marketing Strategies’ Influence on Physicians’ Prescribing Pattern in Lebanon: Ethics, Gifts, and Samples,” BMC Health Services Research 19 (2019): 80; C.A. Marco, J.C. Moskop, R.C. Solomon, J.M. Geiderman, and G.L. Larkin, “Gifts to Physicians from the Pharmaceutical Industry: An Ethical Analysis,” Annals of Emergency Medicine 48, no. 5 (2006): 513-21; S.M. Price, A.C. O’Donoghue, L. Rizzo S. Sapru, and K.J. Aikin, “What Influences Healthcare Providers’ Prescribing Decisions? Results from a National Survey,” Research in Social and Administrative Pharmacy 17, no. 10 (2021): 1770-1779.Google Scholar
The Physician Payment Sunshine Act was introduced in 2010 as part of the US Government’s Affordable Care Act. It requires medical product manufacturers to disclose payments or transfers of items of value made to physicians or teaching hospitals.Google Scholar
Campbell, E.G., Rao, S.R., DesRoches, C.M., et al., “Physician Professionalism and Changes in Physician-Industry Relationships from 2004 to 2009,” Archives of Internal Medicine 170, no. 20 (2010): 1820–1826.CrossRefGoogle ScholarPubMed
Examples of regulatory agencies include the FDA (Food and Drug Administration) in the United States; the EMA (European Medicines Agency) in Europe; or the ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) in Argentina; the ANVISA (Agência Nacional de Vigilância em Saúde) in Brazil; the INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) of Colombia, among others in the region. New molecular entity (NME) is a broader term that encompasses both a new chemical entity (NCE) and a new biological entity (NBE).Google Scholar
For example, the following news piece from Uruguay: <https://www.elobservador.com.uy/nota/los-precios-que-los-laboratorios-cobran-por-los-medicamentos-de-alto-costo-judicializados-y-que-preocupa-al-msp-20238313260?utm_source=planisys&utm_medium=EO-TitularesMatutinos2023&utm_campaign=EO-TitularesMatutinosFinesdesemana2023&utm_content=18> (last visited September 18, 2023)+(last+visited+September+18,+2023)>Google Scholar
N.P. Vasconcelos, Mandado de Segurança ou Ministério da Saúde? Gestores, Procuradores e Respostas Institucionais à Judicialização,Tese de Doutorado, Faculdade de Direito, Universidade de São Paulo, São Paulo, Ministerio de Salud Pública (2019); Judicialización de Procedimientos de Diagnóstico y Terapéuticos a Brindar por el Fondo Nacional de Recursos y su Impacto a Nivel País, Presentación a la Mesa de Diálogo. Montevideo, Uruguay; Caja Costarricense de Seguro Social, Judicialización de Medicamentos en la CCSS y Acceso a Medicamentos de Alto Costo, Power Point presentation (2022).Google Scholar
Id. (Vasconcelos). For another example related to a small municipality of the state of Rio Grande do Sul: D.W.L. Wang and F.V. Terrazas (orgs.), Judicialização da Saúde nos Municípios, Teses Jurídicas, Diagnósticos e Experiências de Gestão, CONASEMS, Brasília, D.F (2023).Google Scholar
Reveiz, L., et al., “Litigios por Derecho a la Salud en Tres Países de América Latina: Revisión Sistemática de la Literatura,” Revista Panamericana de Salud Pública 33, no. 3 (2013): 213–22.CrossRefGoogle Scholar
Bracamonte, S.A. and Cassinerio, J.L., “La Judicialización del Derecho a la Salud,” South Centre, Documento de Investigación 112, Ginebra (2020).Google Scholar
Instituto de Ensino e Pesquisa — INSPER (2019), Judicialização da Saúde no Brasil: Perfil das Demandas, Causas e Propostas de Solução, Conselho Nacional de Justiça.Google Scholar
Conselho Nacional de Justiça (CNJ), “Fórum Nacional do Judiciário para a Saúde (Fonajus),” Brasília, Brasil, 2023, available at <https://www.cnj.jus.br/wp-content/uploads/2023/06/todos-os-enunciados-consolidados-jornada-saude.pdf> (last visited September 18, 2023).+(last+visited+September+18,+2023).>Google Scholar
Lee, H.-S., Korman, B.D., Le, J.M., Kastner, D.L., Remmers, E.F., Gregersen, P.K., and Bae, S.-C., “Genetic Risk Factors for Rheumatoid Arthritis Differ in Caucasian and Korean Populations,” Arthritis & Rheumatism 60 (2009): 364–371; J.M. Loree, S. Anand, A. Dasari, et al., “Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals from 2008 to 2018,” JAMA Oncology 5, no. 10 (2019): e191870.CrossRefGoogle Scholar