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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
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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)

Introduction

In this paper, the judicialization of health refers to the increasing involvement of courts on issues related to health and healthcare with the goal of protecting citizens’ health rights. Accordingly, professional negligence or medical malpractice are not included in this definition of health judicialization.Reference Andia and Lamprea 1

Often, courts are called upon to ensure citizens’ access to essential health services and resources when there’s a perceived failure of state action or a violation of health rights. Issues stemming from flaws and inefficiencies in the delivery of healthcare services, the availability of essential medicines, and other covered procedures contribute to the rise of health judicialization. Consequently, this phenomenon can be viewed as the most visible expression of citizens in the pursuit of their health rights.

The impact of health judicialization on the healthcare sector is substantial. It can override, alter, or reverse allocation and prioritization decisions made by policymakers, potentially leading to tensions between two independent branches of power. Furthermore, considering the costs associated with litigation over medications, medical devices, and procedures, judges’ decisions can have a significant budgetary impact.

One of the primary challenges posed by health judicialization is the reconciliation of individual and collective priorities and rights. While courts often deal with specific individual medical cases, sometimes involving quality of life or life-threatening situations, state actions are guided by a collective perspective. Universal healthcare systems establish priorities based on the relevance of morbidity and mortality, comparing the outcomes of health technologies with existing alternatives while considering their budgetary implications. Ultimately, health judicialization may underscore the conflict between the regulatory authority of the state and the autonomy of physicians in making decisions about patient treatment.Reference Reis, Borin, Da Costa, Dresch, Firmo, Guimarães and Guerra 2

Why Is Health Judicialization So Prevalent in Latin America, and What Are Its Underlying Reasons?

The phenomenon of health judicialization can be attributed to an interplay of structural factors, both internal and external to the health sector. On the one hand, some of the factors contributing to judicialization are associated with weaknesses in healthcare systems, including: underfunding or resource misallocation; inadequate or inefficient service provision and subpar quality of care; deficiencies in critical resource availability and flawed pharmaceutical policies; shortages or insufficient distribution of healthcare personnel; managerial inefficiencies; and inadequate information systems, among others.

On the other hand, some of the factors driving health litigation are external to the sector’s policy and decision-makers and are beyond their control. One critical factor is the utilization of marketing strategies by industries to promote healthcare technologies and treatments to physicians, patients, and other influential stakeholders. These strategies frequently involve economic incentives and the funding of scientific research and publications authored or supported by influential medical professionals or professors from prestigious universities. Additionally, commercial and intellectual property regulations and agreements also play a role in restricting access to more affordable alternative technologies, such as generic or biosimilar medicines. 3

Although these factors are common in many developing economies, the phenomenon of health judicialization is particularly pronounced in Latin America due to certain distinctive characteristics of the region. Estimations based on data from the late nineties through the first decade of the new millennium reveal that, on average, there were 1,800 health rights litigations per million inhabitants per year in Colombia, 206 per million in Brazil, 109 per million in Costa Rica, and 29 per million in Argentina. In contrast, South Africa and India had cumulative figures of 0.3 and 0.2 health rights litigations per million inhabitants for the same period, respectively.4

The phenomenon of health judicialization is particularly pronounced in Latin America due to certain distinctive characteristics of the region. Estimations based on data from the late nineties through the first decade of the new millennium reveal that, on average, there were 1,800 health rights litigations per million inhabitants per year in Colombia, 206 per million in Brazil, 109 per million in Costa Rica, and 29 per million in Argentina. In contrast, South Africa and India had cumulative figures of 0.3 and 0.2 health rights litigations per million inhabitants for the same period, respectively.

To underscore the significance of this phenomenon in the region, available data reveal a remarkable surge in health litigations in recent years:

  • • In Colombia, the number of right-to-health litigations increased by 119% between 2010 and 2019, resulting in a 98% rise in the litigation rate per population during the same period. 5

  • • Brazil witnessed a 130% growth in right-to-health lawsuits between 2008 and 2017, compared to a 50% increase in the overall number of lawsuits during that same time. 6

  • • Uruguay experienced a surge in litigations related to medicines, soaring from 100 to 550 in just three years from 2016 to 2019, leading to an almost fourfold increase in spending on high-cost drugs. 7

  • • The number of health litigations against Costa Rica’s Caja Costarricense de Seguro Social increased by 144% between 2009 and 2019. Spending on medicines resulting from these lawsuits accounted for over 11% of the institution’s total budget for medicines in 2021, compared to just 2% before 2015. 8

The key legal foundation underlying the judicialization of health in Latin America stems from the recognition of health as an individual right, rather than merely a societal value, within the laws and constitutions of most countries of the region. Furthermore, in addition to constitutional recognition of health as a fundamental right, the legal frameworks of many Latin American nations incorporate provisions, commonly known as “writs of protection” (recursos de amparo or tutelas), that facilitate judicial protection for citizens. These legal arrangements, coupled with a significant degree of judicial activism, where judges actively engage in monitoring and shaping public policy,Reference Abramovich and Pautassi 9 and the presence of a dynamic civil society, provide citizens with effective legal tools and low barriers to seek redress when they perceive inadequate healthcare policies or discriminatory practices that infringe upon their health rights.

Advancements in socioeconomic conditions and healthcare have led to an increase in life expectancy in Latin America. This has, in turn, resulted in rapid population aging and a higher prevalence of non-communicable diseases. 10 The complex nature of these diseases, coupled with the development of new and expensive medical technologies for their diagnosis and treatment, poses both technical and financial challenges to healthcare systems. This situation has created a disconnect between citizens’ needs and expectations and the healthcare systems’ capacity to meet these demands, thus serving as a potential catalyst for judicial claims.

Moreover, the funding and organizational models used by many Latin American countries to provide access to pharmaceuticals differ from those employed by most universal healthcare systems in developed countries within the Organization for Economic Cooperation and Development (OECD). In Brazil, for example, the management of the pharmaceutical supply chain and the distribution of medicines to patients are handled by public facilities.Reference Garcia, Azevedo, Mirelman, Safatle, Iunes, Bennie, Godman and Junior 11 Nevertheless, these services are often overwhelmed with various responsibilities, leading to frequent shortages or limited availability of essential drugs.Reference Guerra Júnior, Acúrcio, Gomes, Miralles, Girardi and Werneck 12 This lack of essential drugs are significant drivers of judicialization, as will be shown below. In contrast, in European countries, Australia, Canada, and other OECD-affiliated universal healthcare systems, medicines covered by the healthcare system are dispensed through private community pharmacies and publicly financed via reimbursement systems.

Types of Litigation

Figure 1 provides an illustration of four potential scenarios that can lead to judicialization, considering two key factors. Firstly, it assesses whether a health good or service is classified as essential by the health system and whether the system has committed to providing it to its beneficiaries. Secondly, it examines whether individuals have access to the said good or service:

  • • In the first scenario, depicted in the northeast quadrant, litigation is unnecessary because patients already have access to the health goods and services provided by the health system.

  • • Quadrant two represents a scenario with the potential for allocative inefficiency or resource wastage. Here, individuals have access to health goods and services that the health system’s assessment and prioritization frameworks have categorized as nonessential.

  • • Quadrants three and four represent the two primary forms of health judicialization. In the former, patients turn to the courts to access goods or services that the health system does not provide due to various reasons: (1) the system’s evaluation process has determined that they do not offer greater benefits than existing alternatives; (2) these goods or services are not considered an epidemiological priority from a collective perspective; (3) they are economically unfeasible for the country; (4) they are new, and their safety and cost-effectiveness have not yet been evaluated by the health system; or (5) inefficiencies or technical limitations have hindered the health system from offering these goods or services to patients. In this regard, litigations that align with the scenarios outlined in quadrant three depict situations characterized by a direct conflict with the priorities set by the health system. These litigations correspond to judicialization types B and C as defined in the taxonomy established by Freiberg and Espin.Reference Freiberg and Espin 13 In fact, one could argue that they essentially constitute the judicialization of the country’s health policies and prioritization decisions.

  • • In the last scenario, quadrant four, patients resort to the courts to obtain health goods and services that the health system is expected to provide but fails to do so for the reasons outlined in the previous section (referred to as judicialization type A in the taxonomy by Frieberg and Espin mentioned above).

Figure 1 Source: Based on L. Cubillos, M.-L. Escobar, S. Pavlovic, and R. Iunes, “Universal Health Coverage and Litigation in Latin America,” Journal of Health Organization and Management 26, no. 3 (2012): 390-406.

The significance of this last type of litigation cannot be overstated. A sample of the 2021 health judicialization data collected by Colombia’s Constitutional Court, for instance, reveals that approximately 74% of the lawsuits pertain to services, goods, or inputs that are included in the benefit package but have either been delayed or not provided to patients. 14 In the northern Brazilian state of Pará, nearly 70% of litigation cases revolve around medicines listed in the country’s covered drugs or essential medicines list. 15 Similarly, data from 2010 in the southeastern state of Minas Gerais indicates that roughly half of the cases involved medicines found in the essential list.Reference Machado 16

Discussion

Medicines are among the most commonly litigated subjects. In Colombia, for instance, they often represent the first or second most frequent cause of litigation, accounting for approximately 25% of all cases.17 Since the provision of healthcare is inseparable from access to medicines, these technologies are regarded as an integral part of the fundamental right to health, safeguarded by the constitutional and legal frameworks of Latin American countries. Consequently, the lack of access to medicines constitutes a direct violation of the right to health.

As discussed in another paper within this series, out-of-pocket expenses incurred by families constitute a significant portion of Latin America’s overall healthcare expenditures, with medicines being the largest single out-of-pocket expense for families. In this context, the inability to access medicines can impose a substantial financial burden on families and serve as a driving force behind their recourse to the judicial system. Health judicialization, therefore, can facilitate access to both newly developed and established medicines for individuals who might otherwise be unable to afford them. This is particularly advantageous for patients requiring high-cost treatments, such as those with rare diseases, cancers, or other life-threatening conditions, as well as cases where limited treatment options exist.

Physicians play a pivotal role in health judicialization, especially when concerning medicines, as the entire litigation process hinges on the presence of a valid prescription. Marketing strategies and the financing or support to individual physicians, medical societies, and patient organizations are some of the ways in which the pharmaceutical industry may influence physicians and patients to demand, including through the courts, their products over alternatives already present in the health system’s benefit package. A 2009 survey of American doctors found that almost 84% of physicians had some financial interaction with the pharmaceutical, medical supply, medical device, and biological industries.Reference Campbell, Rao and DesRoches 18 The impact of these strategies is well documented and show that they play an important role in the prescribing behavior of physicians and the diffusion of information regarding new products. Prosser and colleagues, for instance, show that specialists are significantly more likely to prescribe off-label and serve as opinion leaders for the pharmaceutical industry compared to other provider groups.Reference Prosser, Almond and Walley 19

These strategies may even influence the professional development of doctors, as marketing strategies often rely on hiring renowned medical speakers associated with academia/universities to lead continuous training programs. These practices contribute to the construction of a common agenda across medical societies, patient organizations, and physicians, which, sometimes can lead to conflicts of interests and potentially to supply-induced demands, some manifested through judicialization, as they conflict with current protocols and guidelines. Physicians may, for instance, insist on prescribing new or brand-name drugs instead of approved generics and biosimilar drugs, even resorting to litigation to assert their medical authority over patient care. This can occur in scenarios marked by uncertainty, insufficient evidence, or instances where treatments are not listed or have been denied due to high cost-effectiveness ratios.

Growing awareness of the potential bias and conflicts of interest resulting from these practices has led to the implementation of measures aimed at increasing transparency in financial relationships between professionals and the medical industry. For example, the United States government introduced the Physician Payments Sunshine Act (PPSA) in 2010. 20 Over time, academic institutions, journals, and professional organizations have also adopted conflict-of-interest and transparency policies to counteract the industry’s influence on medical education and research.Reference Campbell, Rao and DesRoches 21

In Latin America, Colombia implemented a resolution in 2018 that mandates medical companies (including pharmaceutical firms, importers of pharmaceutical products, medical device manufacturers, etc.) to disclose payments and transfers of goods and services to physicians. In 2016, the state of Minas Gerais in Brazil approved a regulation requiring companies to report information about donations or benefits provided to healthcare professionals, such as conference registrations, trips, gifts, research funding, and more. The regulation also stipulates that the state is responsible for making this information publicly accessible by publishing it on official websites. Chilean doctors established in 2012 the non-governmental organization Médicos Sin Marca (Doctors without a Brand) with the goal of promoting a clinical practice that is free from the influence of propaganda and incentives from the pharmaceutical and medical device industries. In 2016, Médicos Sin Marca Colombia was also established.

Furthermore, the potential influence of the biomedical and pharmaceutical industries can be present even before a medicine becomes classified as essential within a country. Typically, when a pharmaceutical regulatory agency accepts a new molecular entity (NME), it implies that an analysis of its patents and clinical studies has been conducted, with results published and presented in medical journals and conferences. 22 When an NME is submitted for evaluation to be included in the health system, it is presented as an innovation and an improvement over existing technologies. To be granted NME status, the drug must demonstrate chemical differences. However, it is common to encounter analogous products with minor molecular differences that request and receive NME status. Additionally, some drugs may be prescribed for uses other than those for which they were originally approved, a practice known as off-label prescription or use. For instance, many NMEs developed for late-stage diseases, such as those used in cancer treatments, are often marketed directly to patients and physicians for use in the early phases of treatment, expanding the user base and increasing the budgetary impact on the healthcare system.

All these scenarios create opportunities for litigation. Drugs that have not demonstrated additional health benefits compared to existing technologies or medicines with minor variations from established alternatives are pursued through legal action. Judges are then asked to authorize the prescription and dispensation of a drug for a purpose different from its original approval by health authorities. Health judicialization, in this sense, can lead to unexpected financial burdens on healthcare systems, as they may be compelled to provide costly medications not initially budgeted for or to cover treatments that were not originally planned. This can strain healthcare budgets and potentially affect the allocation of resources for other health interventions. Moreover, the often short time limits imposed by judicial orders hinder the health sector from following typical procurement procedures or negotiating discounts, forcing governments to pay higher market prices for drugs provided through judicialization. 23 Consequently, governments may be pressured to incorporate these drugs to mitigate the financial burden imposed by judicialization. It is not surprising, therefore, that health judicialization has a substantial budgetary impact. For example, in the state of Sao Paulo, Brazil, the costs associated with judicialization accounted for 4% of the state’s total health budget in 2016. In the state of Santa Catarina, this proportion increased from 1% in 2004 to 8% in 2016. In Uruguay, in 2019, approximately 53% of expenditures on high-cost medicines were due to judicialization, and in Costa Rica, if the current trend continues, expenditures by the Caja Costarricense de Seguro Social on medicines through judicialization in 2030 could represent 25% of the institution’s total spending on medicines.24

Final Reflections

Addressing the determinants of health litigations described in quadrant four in Figure 1 — those cases in which health systems violate citizens’ rights by not providing medicines included in their benefit packages or lists of essential medicines — should be a top priority for Latin American policy makers. Fortunately, there are already successful examples that could serve as a basis for adaptation and scaling up. In Colombia’s department of Caldas, for instance, more than 82% of cases presented to the health system between November 2018 and May 2019 were resolved within 48 hours without the need for litigation. Similarly, in Brazil, specifically in the state of Rio Grande do Sul, administrative measures introduced enabled the state to address 85% of the judicial demands presented in the state’s capital in 2015.25

The first thing that needs to be recognized is the fact that physicians and other health decision-makers also need more knowledge and better information. The rapid technological innovation of recent years has produced extremely expensive and highly specific drugs. More and more, biological medicines based on molecular targets defined by genetics are used in complex clinical conditions such as some types of cancer, diseases that compromise the immune system, inflammatory or infectious diseases, and the so-called orphan diseases. The high cost of these medicines, combined with the fact that these diseases can also have significant social repercussions and/or a serious risk of death, creates the perfect scenario for health judicialization associated with the third (southwest) quadrant of Figure 1 and helps explain the very rapid growth of litigations presented earlier in this paper.

Considering the significant policy and budgetary impact of health judicialization, and given that in most cases judges tend to rule in favor of the patient — for example, in Colombia, 75% to 87% of cases favor the claimant; in Costa Rica, these numbers nearly reach 90%; in Brazil, they range between 70% and 100%;Reference Reveiz26 and in Argentina, this proportion is estimated to be around 89%Reference Bracamonte and Cassinerio27 — governments in the region have proposed training programs for judges on health topics and evidence-based medicine, and/or have developed tools and mechanisms to support judges in their decision-making process to uphold their authority and maintain a health system-based decision-making logic. In Brazil, the National Justice Council (CNJ), the technical secretariat of the country’s Supreme Court, recommended the establishment of technical support centers in each state to assist magistrates in resolving health-related demands. These centers, known as NAT-Jus, prepare technical notes for judges, with the expectation that decisions will be made with more information and confidence.28 The CNJ is also promoting national agreements outlining the criteria that judges throughout the country should consider when authorizing treatments or new technologies.29

While these measures may have merit — as judges may lack adequate evidence-based medical knowledge and information to make urgent decisions relying exclusively on a physician’s report — they are incomplete and are likely to have a limited impact. Firstly, because they ignore the fact noted earlier in this paper that judicialization would not exist without a prescription from a doctor; and secondly, because most judicial decisions have swift effects, with expenditures happening immediately. When stronger medical evidence is presented, patients have already received the technology demanded, limiting the feasibility of reversing the decision if found incorrect. In this sense, singling out the judge as the weakest link within the health judicialization process is an error.

The first thing that needs to be recognized is the fact that physicians and other health decision-makers also need more knowledge and better information. The rapid technological innovation of recent years has produced extremely expensive and highly specific drugs. More and more, biological medicines based on molecular targets defined by genetics are used in complex clinical conditions such as some types of cancer, diseases that compromise the immune system, inflammatory or infectious diseases, and the so-called orphan diseases. The high cost of these medicines, combined with the fact that these diseases can also have significant social repercussions and/or a serious risk of death, creates the perfect scenario for health judicialization associated with the third (southwest) quadrant of Figure 1 and helps explain the very rapid growth of litigations presented earlier in this paper.

However, health decision-makers — whether they are health professionals making decisions for individual patients, such as physicians, or those responsible for carrying out health technology assessments (HTAs) that recommend the incorporation of medicines — often have to rely on limited information derived from increasingly smaller clinical trials, surrogate outcomes, questionnaires, or even population characteristics and types of care that differ significantly from what is seen in Latin American and other developing countries.Reference Lee, Korman, Le, Kastner, Remmers, Gregersen and Bae30 This means that HTA personnel often lack the appropriate real-world data to measure and estimate the cost-effectiveness of these drugs accurately in terms of improving survival rates and patients’ quality of life within each country and context. These issues can only be addressed by generating real-world data that can be used for informed decision-making. As much as the citizens of Latin America need better access to medicines, they also need access to medicines that will have the expected beneficial impact on them.

Finally, it must be emphasized that new drugs are frequently very expensive and unaffordable for many public health systems, especially those in low- and middle-income countries, and can act as barriers to their incorporation by healthcare systems, thus perpetuating obstacles to accessing medicines and contributing to judicialization. This is an international problem that requires further debate on the necessity of mechanisms for price regulation and changes in pricing strategies.

Note

The authors do not have any conflicts of interest to disclose.

Acknowledgments

We would like to thank William Savedoff for his insightful comments.

The authors have benefited from the many years of learning from the colleagues of the SaluDerecho Initiativie (www. saluderecho.net), who have contributed with their expertise and commitment to the progressive realization of the right to health in Latin America. Any errors and omissions are, of course, ours.

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
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Figure 1 Source: Based on L. Cubillos, M.-L. Escobar, S. Pavlovic, and R. Iunes, “Universal Health Coverage and Litigation in Latin America,” Journal of Health Organization and Management 26, no. 3 (2012): 390-406.