ABSTRACT

This study discusses the impacts of judicialization on the guarantee of the right to health in Brazil and the need to reassess the role of the Judicial system in its protection. We used evidence from the technical-scientific literature and information on the budgetary-financial execution and the acquisition of medicines from the Brazilian Ministry of Health to substantiate the arguments. In 2019, lawsuits consumed 25.2% of the resources of the Specialized Component of Pharmaceutical Care, 21% for 10 medicines. Although the Judicial promotes this right when the State fails to ensure access to medicines incorporated into the Brazilian Unified Health System (SUS), this system compromises access to medicines of the population with the determinations of acquisition of non-incorporated products. The Judicial needs to guide its control over compliance with constitutional and legal precepts in public policies, especially in fiscal policy, given its impact on the financing of the SUS.

Health’s Judicialization; Access to Essential Medicines and Health Technologies; Equity in the Resource Allocation; Unified Health System; Right to Health

INTRODUCTION

In Brazil, lawsuits in the health field became more important in recent decades due to the significant increase in cases and their impacts, especially for the Brazilian Unified Health System (SUS). The judicialization of health can be understood as a situation of expansion of the activation of the Judicial by individuals or groups of individuals, citizens or consumers, to arbitrate conflicts of this system with the Executive Branch, with private companies and individuals in healthmatters¹1. Vieira FS. Direito à saúde no Brasil: seus contornos, judicialização e a necessidade da macrojustiça. Brasília, DF: Ipea; 2020 [cited 2022 Jan 15]. (Texto para Discussão; nº 2547). Available from: https://bit.ly/35bGxYm
https://bit.ly/35bGxYm... .

In cases where the defendant is the State, the impact of judicialization on the guarantee of the right to health is positive or negative. On one hand, judicialization would be beneficial because it constitutes a means to ensure the right to health and to induce improvement in the response of the State²2. Ventura M, Simas L, Pepe VLE, Schramm RF. Judicialização da saúde, acesso à justiça e a efetividade do direito à saúde. Physis. 2010;20(1):77-100. https://doi.org/10.1590/S0103-73312010000100006
https://doi.org/10.1590/S0103-7331201000... . On the other hand, judicialization would produce unequal treatment among citizens in a country marked by great socioeconomic inequalities and health inequities³3. Wang DWL. Right to health litigation in Brazil: the problem and the institutional responses. Hum Rights Law Rev. 2015;15(4):617-41. https://doi.org/10.1093/hrlr/ngv025
https://doi.org/10.1093/hrlr/ngv025... ,⁴4. Ferraz OLM. Health as a human right: the politics and judicialisation of health in Brazil. New York: Cambridge University Press; 2020..

In the SUS, lawsuits demand medicines⁵5. Instituto de Ensino e Pesquisa (INSPER). Judicialização da saúde no Brasil: perfil das demandas, causas e propostas de solução. Brasília, DF: Conselho Nacional de Justiça; 2019 [cited 2022 Jan 15]. Available from: https://bit.ly/3Gg4PgY
https://bit.ly/3Gg4PgY... due to failures in the supply of incorporated products and request experimental or approved medicines for commercialization, but not incorporated into the system⁴4. Ferraz OLM. Health as a human right: the politics and judicialisation of health in Brazil. New York: Cambridge University Press; 2020.,⁷7. Catanheide ID, Lisboa ES, Souza LEPF. Características da judicialização do acesso a medicamentos no Brasil: uma revisão sistemática. Physis. 2016;26(4):1335-56. https://doi.org/10.1590/S0103-73312016000400014
https://doi.org/10.1590/S0103-7331201600... . These situations may be prevalent, depending on the locality, and are important in assessing the impacts of health judicialization.

Thus, considering the relevance of this theme, this study aimed to discuss the impacts of the current model of judicialization on the guarantee of the right to health in Brazil and the need to reevaluate the role of the Judicial in the protection of this right.

We obtained evidence from the technical-scientific literature on the judicialization of health and the financing of the SUS by research done in the Virtual Health Library, in the field “title, abstract and subject”, for documents published since 2000, including all bases and using the words: i) “judicialization” and “health”; (ii) “financing” and “SUS”. We also consulted references on these topics in documents and publications of the National Council of Justice (CNJ). We selected studies addressing the following themes: consequences of lawsuits for health policy, theory of the reservation of the possible, and role of the Judicial in the protection of social rights.

Data from the following information systems were also obtained to substantiate the arguments: i) Justice in Numbers Panel of CNJ: new cases of judicial demand (2014 to 2020); ii) Integrated General Services Administration System (SIASG): acquisition of medicines by the Brazilian Ministry of Health (MS) (2016-2020); and iii) Siga Brasil tool: budget-financial execution of the MS (2012-2020).

Positive and Negative Consequences of Judicialization

The judicialization of public health began in the 1990s with lawsuits that demanded treatment for HIV-positive people. Decisions in favor of patients represented an advance in ensuring universal and integral access to health services and goods⁸8. Ministério da Saúde (BR), Secretaria de Vigilância em Saúde, Programa Nacional de DST e Aids. O remédio via Justiça: um estudo sobre o acesso a novos medicamentos e exames em HIV/aids no Brasil por meio de ações judiciais. Brasília, DF; 2005 [cited 2022 Jan 15]. (Série Legislação; nº 3). Available from: https://bit.ly/3G9u1Wh
https://bit.ly/3G9u1Wh... . Since then, the demands have diversified and multiplied, mostly individually, favoring the perception that, although part of them is relevant to ensure the right to health, another part has the potential to disorganize the SUS⁹9. Oliveira VE. Caminhos da judicialização do direito à saúde. In: Oliveira VE, organizadora. Judicialização de políticas públicas no Brasil. Rio de Janeiro: Editora Fiocruz, 2019. p. 177-99..

Several institutions implemented measures to broaden the dialogue between the systems and establish beacons for judicial decisions. However, despite the efforts made¹1. Vieira FS. Direito à saúde no Brasil: seus contornos, judicialização e a necessidade da macrojustiça. Brasília, DF: Ipea; 2020 [cited 2022 Jan 15]. (Texto para Discussão; nº 2547). Available from: https://bit.ly/35bGxYm
https://bit.ly/35bGxYm... , the new cases did not decrease (Figure 1). The year of 2020 is atypical because of the negative impacts of the COVID-19 pandemic on the demand and supply of health services¹⁰10. Mendes EV. O lado oculto de uma pandemia: a terceira onda da Covid-19 ou o paciente invisível. Brasília, DF: Conass; 2020. and other public services, including those of the justice system.

The statements of the CNJ, published since 2014 as guidelines to magistrates in the face of the judicialization of health¹¹11. Conselho Nacional de Justiça. Enunciados da I, II e III Jornadas de Direito da Saúde do Conselho Nacional de Justiça. Brasília, DF: CNJ; 2019 [cited 2022 Jan 15]. Available from: https://bit.ly/3KSjQsQ
https://bit.ly/3KSjQsQ... , also appeared ineffective. From 2008 to 2017, the mention of statements was of 0.02% in first instance decisions and less than 0.01% in second instance decisions⁵5. Instituto de Ensino e Pesquisa (INSPER). Judicialização da saúde no Brasil: perfil das demandas, causas e propostas de solução. Brasília, DF: Conselho Nacional de Justiça; 2019 [cited 2022 Jan 15]. Available from: https://bit.ly/3Gg4PgY
https://bit.ly/3Gg4PgY... .

Among the judicialized items acquired by the Brazilian Ministry of Health from 2016 to 2020, most of the 10 medicines with the highest budgetary impact were not incorporated into the SUS (Table). Some decisions also determined the purchase of medicines without registration with the National Health Surveillance Agency (Anvisa), opposite to what guides the statement 50¹¹11. Conselho Nacional de Justiça. Enunciados da I, II e III Jornadas de Direito da Saúde do Conselho Nacional de Justiça. Brasília, DF: CNJ; 2019 [cited 2022 Jan 15]. Available from: https://bit.ly/3KSjQsQ
https://bit.ly/3KSjQsQ... .

The Brazilian Ministry of Health’s expenditure on medicines lawsuits increased significantly between 2012 and 2016 (221%), reaching R$ 1.5 billion last year. It decreased 26% between 2016 and 2017 and remained at R$ 1. billion from 2017 to 2019 (Figure 2).

Studies in the 2000s already showed concern about the consequences of lawsuits. They explained¹²12. Vieira FS, Zuchi P. Distorções causadas pelas ações judiciais à política de medicamentos no Brasil. Rev Saude Publica. 2007;41(2):214-22. https://doi.org/10.1590/S0034-89102007000200007
https://doi.org/10.1590/S0034-8910200700... ,¹³13. Chieffi AL, Barata RB. Judicialização da política pública de assistência farmacêutica e equidade. Cad Saude Publica. 2009;25(8):1839-49. https://doi.org/10.1590/S0102-311X2009000800020
https://doi.org/10.1590/S0102-311X200900... issues such as the disregard of the responsibilities of the federation entities in the organization of the SUS, the purchase of medicines not incorporated and without registration with Anvisa, and losses to equity.

In the last decade, authors linked to the justice system entered the debate, highlighting positive and negative aspects of the judicialization of health, which represents an advance by favoring the discussion on the subject among their peers.

Regarding the positive aspects, we highlight the promotion of the formulation and review of public policies, the inclusion of health in the political agenda, the development of the evaluation of health technologies, and the expansion of dialogue between the powers¹⁴14. Borges DCL. Individual health care litigation in Brazil through a different lens: strengthening health technology assessment and new models of health care governance. Health Hum Rights. 2018;20(1):147-62.,¹⁵15. Gebran Neto JP. Direito constitucional à saúde e suas molduras jurídicas e fáticas. In: Schulze CJ, Gebran Neto JP. Direito à saúde. 2. ed. Porto Alegre, RS: Verbo Jurídico; 2019. p. 99-130..

Regarding the negative aspects, we highlight the disorganization of the SUS and public finances, the undue judicial choices of public policies, the weakening of isonomy, the disregard of the criteria for prioritizing the technologies available, and the expansion of health inequalities³3. Wang DWL. Right to health litigation in Brazil: the problem and the institutional responses. Hum Rights Law Rev. 2015;15(4):617-41. https://doi.org/10.1093/hrlr/ngv025
https://doi.org/10.1093/hrlr/ngv025... ,⁴4. Ferraz OLM. Health as a human right: the politics and judicialisation of health in Brazil. New York: Cambridge University Press; 2020.,¹⁵15. Gebran Neto JP. Direito constitucional à saúde e suas molduras jurídicas e fáticas. In: Schulze CJ, Gebran Neto JP. Direito à saúde. 2. ed. Porto Alegre, RS: Verbo Jurídico; 2019. p. 99-130..

Moreover, the Judicial can consider scientific evidence and determine the supply of technologies not incorporated into the SUS, in a parallel and capillary process throughout the country, which competes with the evaluation of technologies performed by the health system¹1. Vieira FS. Direito à saúde no Brasil: seus contornos, judicialização e a necessidade da macrojustiça. Brasília, DF: Ipea; 2020 [cited 2022 Jan 15]. (Texto para Discussão; nº 2547). Available from: https://bit.ly/35bGxYm
https://bit.ly/35bGxYm... .

This understanding has several implications. Two implications stand out: i) the weakening of policies as a means for guaranteeing the right to health because, with so many exceptions to the National List of Essential Medicines (Rename), the rule, which should be valid for all, is distorted; and (ii) the reduction of the resources provided in the budget of the year to ensure the population’s access to Rename medicines. This second implication is discussed below.

Reservation of the Possible, Judicialization, and Public Budget

Regarding the relationship between the public budget, the judicialization of health, and the theory of the reservation of the possible, the manifestations of public managers and magistrates are opposed. On one hand, managers use this theory to justify the impossibility of meeting the judicial demand, claiming the unavailability of resources to meet it. On the other hand, judges counter-argue that a secondary interest of the State cannot be superimposed on the right to health under the argument of the reservation of the possible. Both positions need to be rethought.

The concept of reservation of the possible came from Germany, where they recognized that issues involving social rights suffer limitation in three dimensions: i) reservation of the factually possible: the satisfaction of demand needs to be feasible; (ii) reservation of the legally possible: the demand needs to be legally possible; and iii) reservation of the financially possible: the demand fulfillment is limited to the state’s financial capacity¹⁶16. Fogaça AR. Análise econômica do direito e judicialização da saúde: mínimo existencial versus reserva do possível. Curitiba, PR: Juruá; 2021..

Regarding the use of the theory of the reservation of the possible by managers, financial capacity of the State is different from the annual budget established for health. The financial capacity of the State is measured considering all the resources collected from society. Revenues limit the capacity to spend on policies that empower social rights, thus society’s participation in the discussion conducted by its representatives on the allocation of resources is fundamental¹⁷17. Jorge EA. Financiamento setorial do SUS e a questão da municipalização da saúde. In: Ministério da Saúde (BR), Coordenação de Informação, Educação e Comunicação. Incentivo à participação popular e controle social no SUS: textos técnicos para conselheiros de saúde. Brasília, DF; 1998 [cited 2022 Jan 15]. p. 45-54. Available from: https://bit.ly/3s1vBnZ
https://bit.ly/3s1vBnZ... . But a shortage of resources considering only the annual health budget cannot be claimed.

Regarding the counter-argument of the magistrates, the financial capacity cannot be considered as a secondary interest of the State. The rights have costs, thus is necessary to measure them and define how they will be financed, as well as control who decides on the resources that will be allocated to realize them¹⁸18. Holmes S, Sunstein CR. The cost of rights: why liberty depends on taxes. New York: Norton, 2000..

When the Judicial ignores the macro-issues related to the subject and determines the supply, for an individual, of medicines not provided for in public policies, it impacts the access of others to the medicines included in the policies¹⁹19. Ferraz OLM, Vieira FS. Direito à saúde, recursos escassos e equidade: os riscos da interpretação judicial dominante. Dados. 2009;52(1):223-51. https://doi.org/10.1590/S0011-52582009000100007
https://doi.org/10.1590/S0011-5258200900... . This occurs because the budget has planning nature and is defined in the year prior to its validity. The reallocation of resources between different areas requires prior legislative authorization, not only the simple will of the health manager²⁰20. Ministério da Economia (BR). Manual de contabilidade aplicada ao setor público. 8. ed. Brasília, DF; 2021. [cited 2022 Jan 15]. Available from: https://bit.ly/3AFSyB0
https://bit.ly/3AFSyB0... and, depending on the economic conditions of the country, the budget constraint may imply tragic choices in the supply of goods and services.

Figures 2 and 3 illustrate this type of problem well. In the Brazilian Ministry of Health, since 2014, resources allocated in the budget action that finance the Specialized Component of Pharmaceutical Assistance (CEAF) also finance the expenses with medicines lawsuits. Considering only the expenditure recorded in this action, the share of expenses for lawsuits has grown since 2012, reaching 25.2% in 2019. As a result, fewer resources finance the list of medicines of this component for the entire population.

Only ten drugs accounted for 94.6% of the expenditure on lawsuits from the Brazilian Ministry of Health in 2019 (R$ 950.33 million) and consumed 21% of the resources allocated to CEAF. Thus, there is a lack of medicines under the responsibility of acquisition of the Ministry of Health²¹21. Conselho Nacional de Secretários de Saúde. Ofício Conass Nº 138. Regularização de entregas de medicamentos referentes à Assistência Farmacêutica (Grupo 1A do CEAF). Brasília, DF: Conass; 2019 [cited 2022 Jan 15]. Available from: https://bit.ly/34O0D8K
https://bit.ly/34O0D8K... ,²²22. Conselho Nacional de Secretários de Saúde. Ofício Conass Nº 523, de 21 de dezembro de 2020. Assunto: Irregularidades no abastecimento dos medicamentos do Componente Especializado de Assistência Farmacêutica sob responsabilidade de aquisição centralizada pelo Ministério da Saúde. Brasília, DF: Conass; 2020 [cited 2022 Jan 15]. Available from: https://bit.ly/3F8zT2N
https://bit.ly/3F8zT2N... , which should have several determinants, but certainly one of them is judicialization.

This example explains how judicialization can cause more harm than promoting the right to health in Brazil. Decisions on resource allocation are complex and require democratic legitimacy. Moreover, they require solid technical knowledge in health. Decisions cannot have as a single foundation criteria denoting humanitarian feelings of solidarity, justice, and empathy for a single individual²³23. Zebulum JC. Decisões judiciais na saúde, um campo propício para a interferência de convicções pessoais de cada juiz: análise da jurisprudência de quatro tribunais de justiça. Rev Dir Sanit. 2019;19(3):16-33. https://doi.org/10.11606/issn.2316-9044.v19i3p16-33
https://doi.org/10.11606/issn.2316-9044.... . Because this leads to decisions that disregard the country’s health legislation and that put people’s health at risk, as in the case of the phosphoethanolamine²⁴24. Santos MWB, Santos AV, Lima CMMA, Abreu APM, Martos ACV, Bernardi AS, et al. O caso da fosfoetanolamina sintética: judicialização com risco à saúde. In: Bucci MPD, Duarte CS, coordenadoras. Judicialização da saúde: a visão do Poder Executivo. São Paulo: Saraiva; 2017. p. 139-73.. Finally, how could the Judicial better protect the right to health?

Need for New Directions

The Judicial plays an important role by determining that the State fulfills its duty to ensure the supply of medicines incorporated into the SUS, in compliance with the guidelines and regulations of public policies. In a recent survey, 46% of magistrates said that they did not observe guidelines and regulations⁶6. Conselho Nacional de Justiça. Judicialização e sociedade: ações para acesso à saúde pública de qualidade. Brasília, DF: CNJ; 2021 [cited 2022 Jan 15]. Available from: https://bit.ly/32FwYAf
https://bit.ly/32FwYAf... .

Meanwhile, fiscal policy decisions are taken within the Union with a great negative impact on social rights, such as the implementation of the spending ceiling for primary expenditures, the freezing of minimum applications in health and education, the absence of limitation of financial expenses, and the expansion of tax expenditure²⁵25. Vieira FS, Piola SF, Benevides RPS. Vinculação orçamentária do gasto em saúde no Brasil: resultados e argumentos a seu favor. Rio de Janeiro: Ipea; 2019 [cited 2022 Jan 15]. (Texto para Discussão; nº 2516). Available from: https://bit.ly/2JO4lUp
https://bit.ly/2JO4lUp... .

Given the importance of fiscal policy to guarantee rights, human rights principles for fiscal policy are discussed, aiming to approximate Economy and Law²⁶26. Instituto de Estudos Socioeconômicos. Princípios de direitos humanos na política fiscal. Brasília, DF: INESC; 2022. [cited 2022 Jan 15]. Available from: https://bit.ly/3uang3X
https://bit.ly/3uang3X... . The Judicial needs to exercise macrojustice, which demands control over processes involving macroeconomic policies that affect the funding of SUS¹1. Vieira FS. Direito à saúde no Brasil: seus contornos, judicialização e a necessidade da macrojustiça. Brasília, DF: Ipea; 2020 [cited 2022 Jan 15]. (Texto para Discussão; nº 2547). Available from: https://bit.ly/35bGxYm
https://bit.ly/35bGxYm... ,²⁷27. Pinto EG. Estado de coisas inconstitucional na política pública de saúde brasileira. Rio de Janeiro: Fiocruz; 2016. (Textos para Debate). [cited 2022 Jan 15]. Available from: https://bit.ly/3IHYkoy
https://bit.ly/3IHYkoy... . If the Judicial does not exercise macrojustice, it will continue to promote health inequities.

Thus, it is necessary to reflect on the role of the Judicial in the protection of social rights. According to Ferraz²⁸28. Ferraz OLM. Harming the poor through social rights litigation: lessons from Brazil. Tex Law Rev. 2011 [cited 2022 Jan 15];89:1643-1668. Available from: https://bit.ly/3KRUFq5
https://bit.ly/3KRUFq5... (2011), social rights would be adequately protected if the Judicial stopped interfering in the content of policies and began to act in the control of their formulation to ensure respect for constitutional and legal norms. Gebran Neto¹⁵15. Gebran Neto JP. Direito constitucional à saúde e suas molduras jurídicas e fáticas. In: Schulze CJ, Gebran Neto JP. Direito à saúde. 2. ed. Porto Alegre, RS: Verbo Jurídico; 2019. p. 99-130. (2019) has the same position.

Therefore, the role of the Judicial in ensuring access to medicines incorporated into the SUS, respecting the standards established within the health system, is not questioned. If the norms and procedures are questionable, considering the goals of the Federal Constitution of 1988 and the laws, the norms and procedures are discussed. But it is unreasonable to allocate resources by lawsuits for the purchase of unincorporated medicines. These allocations mischaracterize the general rule that should be applied to all and drain scarce resources, while the SUS is subjected to a chronic underfunding process²⁹29. Rossi P, Dweck E. Impactos do novo regime fiscal na saúde e educação. Cad Saude Publica. 2016;32(12):e00194316. https://doi.org/10.1590/0102-311X00194316
https://doi.org/10.1590/0102-311X0019431... ,³⁰30. Santos IS, Vieira FS. Direito à saúde e austeridade fiscal: o caso brasileiro em perspectiva internacional. Cien Saude Colet. 2018;23(7):2303-14. https://doi.org/10.1590/1413-81232018237.09192018
https://doi.org/10.1590/1413-81232018237... . Therefore, universality is impaired and the right to health remains denied to the most socioeconomically disadvantaged.

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