ABSTRACT

Objective:

To analyze the national and international scientific evidence available in the literature on types of judicialization of health lawsuits.

Method:

Integrative review, which selected primary studies in the PubMed, LILACS, Web of Science and Scopus databases, with the

Descriptors:

judicial decisions, health’s judicialization, Saúde (in Portuguese), Health, and the keyword: Judicial Action.

Results:

30 studies were selected. In Brazil, the majority were legal claims for medicines and the other for medical errors, requests for vaccines, supplies for diabetics, food compounds, surgical procedure, examinations, among others. In international studies, lawsuits were found for medication, benefit coverage and hospitalization for psychiatric treatment.

Conclusion:

It is evident that the most demanded type of lawsuit was access to the medication at an international level. It is still more noticeable the little discussion on this subject, demonstrating that judicialization of medicines can indicate a reality of Brazil.

Descriptors:
Health’s Judicialization; Judicial Decisions; Health; Right to Health; Public Health Policy

RESUMEN

Objetivo:

Analizar las evidencias científicas nacionales e internacionales disponibles en la literatura sobre los tipos de acciones de judicialización de la salud.

Método:

Revisión integrativa, que seleccionó estudios primarios en las bases de datos PubMed, LILACS, Web of Science y Scopus, con los

Descriptores:

decisiones judiciales, judicialización de la salud, Salud, Health, y la palabra clave: Judicial Action.

Resultados:

Se seleccionaron 30 estudios, siendo que en Brasil, la mayoría se trataba de demandas judiciales por medicamentos y las demás por acciones por error médico, solicitud por vacunas, insumos para diabéticos, compuestos alimentarios, procedimiento quirúrgico, exámenes, entre otras. En estudios internacionales, se encontraron acciones por medicamentos, cobertura de beneficios e internación para tratamiento psiquiátrico.

Conclusión:

Se evidencia que el tipo de acción más demandada fue el acceso al medicamento a nivel internacional. Es aún más perceptible la poca discusión sobre esta temática, demostrando que la judicialización de medicamentos puede indicar una realidad característica de Brasil.

Descriptores:
Judicialización de la Salud; Decisiones Judiciales; salud; Derecho a la Salud; Política Pública de Salud

RESUMO

Objetivo:

Analisar as evidências científicas nacionais e internacionais disponíveis na literatura sobre os tipos de ações de judicialização da saúde.

Método:

Revisão integrativa, que selecionou estudos primários nas bases de dados PubMed, LILACS, Web of Science e Scopus, com os

Descritores:

decisões judiciais, judicialização da saúde, Saúde, Health, e a palavra-chave: Judicial Action.

Resultados:

Foram selecionados 30 estudos, sendo que no Brasil, a maioria se tratava de demandas judiciais por medicamentos e as demais por ações por erro médico, solicitação por vacinas, insumos para diabéticos, compostos alimentares, procedimento cirúrgico, exames, entre outras. Em estudos internacionais, foram encontradas ações por medicamentos, cobertura de benefícios e internação para tratamento psiquiátrico.

Conclusão:

Evidencia-se que o tipo de ação mais demandada foi o acesso ao medicamento a nível internacional. Ainda é mais perceptível a pouca discussão sobre essa temática, demonstrando que a judicialização de medicamentos pode indicar uma realidade característica do Brasil.

Descritores:
Judicialização da Saúde; Decisões Judiciais; Saúde; Direito à Saúde; Política Pública de Saúde

INTRODUCTION

The fact that the Constitution of the Federative Republic of Brazil of 1988⁽¹1 Presidência da República (BR), Casa Civil, Subchefia para Assuntos Jurídicos Constituição da República Federativa do Brasil, 1988 [Internet]. Diário Oficial da União: República Federativa do Brasil; 1998 [cited 2019 Mar 12]. Oct 5. Seção 1: [about 35 screens]. Available from: http://www.planalto.gov.br/ccivil_03/Constituicao/Constituicao.htm
http://www.planalto.gov.br/ccivil_03/Con... ⁾, in its art. 196, describe that “health is the right of all and the duty of the State, guaranteed by social and economic policies aimed at reducing the risk of diseases, and universal and equal access to lawsuits and services for their promotion, protection and recovery”, initiated a phenomenon that today is denominated “judicialization of health”. This phenomenon is interpreted as the costing of medical procedures, medications, treatments, hospitalizations, orthoses and prostheses by judicial means.

In Brazil, judicialization of health began in the 1990s, with a high demand for lawsuits by the Judiciary to ensure that managers of public health services provided antiretroviral medications. For the organization and regulation of the distribution of these medicines, the Política Pública de Distribuição Gratuita de Medicamentos (Public Policy for the Free Distribution of Medicines) was established through Law 9313/1996, which ensured free and universal distribution of antiretroviral agents. It was hoped that, with the implementation of this law, there would be a decrease in judicial demands which did not occur⁽²2 Presidência da República (BR), Casa Civil, Subchefia para Assuntos Jurídicos. Lei n° 9.313, de 13 de novembro de 1996. Dispõe sobre a distribuição gratuita de medicamentos aos portadores do HIV e doentes de AIDS [Internet]. Diário Oficial da União: República Federativa do Brasil; 1996 [cited 2019 Mar 12]. Nov 11, Seção 1: [about 2 screens]. Available from: http://www.planalto.gov.br/ccivil_03/LEIS/L9313.htm
http://www.planalto.gov.br/ccivil_03/LEI... ^,33 Oliveira MRM, Delduque MC, Sousa MF, Mendonça AVM. Mediation : a way to disjudialize health. Temp Act Saúde Col [Internet]. 2016 [cited 2019 Mar 12];10(1):169-77. Available from: http://dx.doi.org/10.18569/tempus.v10i1.1860 Portuguese.
http://dx.doi.org/10.18569/tempus.v10i1.... ⁾.

According to a study carried out by the Oswaldo Cruz Foundation - Fiocruz, “Judicialização da Política de Saúde nos Municípios Brasileiros: Um retrato nacional”, a profile of the judicialization was presented in the city of São Paulo, following a pattern presented in the national survey, where 65% relating to medicinal products⁽⁴4 Fundação Oswaldo Cruz (FioCruz). Judicialização da Política de Saúde nos Municípios Brasileiros: um retrato nacional [Internet] Rio de Janeiro: FioCruz; 2018 [cited 2019 Mar 12]. Available from: http://amazonia.fiocruz.br/index.php/2018/01/25/estudo-traca-panorama-da-judicializacao-da-saude-no-brasil/
http://amazonia.fiocruz.br/index.php/201... ⁾. This issue is of great relevance to public administration, since the number of lawsuits that are filed with the Municipalities, States or the Federation to grant health treatment is high, resulting in one more expense to the public sector to effect such payments⁽⁵5 Zago B, Swiech LM, Bonamigo EL, Schlemper JBR. [Bioethical Aspects of Health Judicialization for journal in 13 Municipalities in the Midwest of Santa Catarina, Brazil]. Act Bioethica [Internet]. 2016 [cited 2019 Mar 12];22(2):293-302. Available from: http://dx.doi.org/10.4067/S1726-569X2016000200016
http://dx.doi.org/10.4067/S1726-569X2016... ⁾.

During the last decades, judicialization of health has grown in some Latin American countries, such as Colombia which, with the enactment of Law 100/1993, reformulated the health system with the objective of providing universal coverage⁽⁶6 Lamprea E. Colombia’s Right-to-Health Litigation in a Context of Health Care Reform (February 15, 2013). The Right to Health at the Public/Private Divide: A Global Comparative Study. Gross A, Flood C, editors. Cambridge University Press, Forthcoming. Available at SSRN: https://ssrn.com/abstract=2255658
https://ssrn.com/abstract=2255658... ⁾. In Colombia, 640,000 lawsuits were filed by patients between 1999 and 2008, one of the highest rates of judicialization of health. In Argentina, 72% of lawsuits are of individual demands for access to medicines⁽⁷7 Yamin AE, Siri G. Litigating health rights: Can courts bring more justice to health? Vol. 3. Harvard University Press, 2011.⁾.

This study was carried out in the expectation of understanding aspects related to the increase of lawsuits for access to health services in Brazil; and, with this, to identify measures or alternatives to be adopted to reduce these lawsuits, as well as to identify gaps in knowledge on the subject.

OBJECTIVE

This study aims to analyze the national and international scientific evidence available in the literature on types of judicialization of health lawsuits.

METHOD

Study design

It is an integrative review, a method that aims to gather and synthesize the published studies, allowing general conclusions on a specific theme, and explanation of knowledge gaps⁽⁸8 Soares CB, Hoga LA, Peduzzi M, Sangaleti C, Yonekura T, Silva DR. Integrative review: Concepts and methods used in Nursing. Rev Esc Enferm USP [Internet]. 2014 [cited 2019 Mar 12]; 48(2):329-39. Available from: http://dx.doi.org/10.1590/S0080-6234201400002000020
http://dx.doi.org/10.1590/S0080-62342014... ⁾.

Methodological framework and stages

Evidence Based Practice is the methodological framework adopted. The study involved the following steps: elaboration of the research question, literature search of primary studies, data extraction, critical evaluation of the included primary studies, analysis and synthesis of results, and synthesis of the knowledge evidenced⁽⁹9 Mendes KDS, Silveira RCCP, Galvão CM. [Integrative literature review: a research journal to incorporate evidence in health care and nursing]. Texto Contexto Enferm [Internet]. 2008 [cited 2019 Mar 12];17(4):758-64. Available from: http://dx.doi.org/10.1590/S0104-07072008000400018 Portuguese.
http://dx.doi.org/10.1590/S0104-07072008... ⁾.

1^st Stage: Elaboration of the research question

The research question delimited for this study was: “What scientific evidence is available in the literature that analyze the types of judicialization of health lawsuits?”.

2^nd Stage: Literature search of primary studies

The search for primary studies was conducted in September 2017, in the following databases with free access at the institution under study: National Library of Medicine National Institutes of Health (PubMed), Latin American & Caribbean Literature in Health Sciences (LILACS), Web of Science and Scopus.

The controlled descriptors were selected in the Descriptors in Health Science Descriptors (DeCS) and MeSH Database. Thus, to search in LILACS, the following descriptors were used: Judicial decisions, Health and Health’s Judicialization. For Pubmed, Web of Science and Scopus were: Health and the uncontrolled delimited descriptor (keyword) was Judicial Action. In the Pubmed, Web of Science and Scopus databases, the terms were combined as follows: Health AND Judicial Action; and in LILACS: Judicial decisions OR Health’s Judicialization AND Health.

3^rd Stage: Data extraction

For data extraction, authors prepared and used a tool consisting of items related to identification of the article, objective and main results that answered the integrative review’s guiding question.

Criteria of inclusion and exclusion

The inclusion criteria were complete articles in Portuguese, English and/or Spanish, published between 2007 and 2017, available in full that addressed the theme “health lawsuits involving access to all types of health services”. Theses, dissertations, chapter books, theoretical articles, letter to the editor were excluded from the sample of this study.

Articles were searched between 2007 and 2017 in order to find the most recent publications related to the application of legislation, legal conduct and repercussions on the health service.

4^th Stage: Critical evaluation of the included primary studies

Analyzes were performed independently by two reviewers, and the synthesis of the studies was presented in Charts 1 and 2.

5^th Stage: Analysis and synthesis of results

A descriptive analysis of each study was carried out, presenting a synthesis of the main results of these studies in Charts 1 and 2.

6^th Stage: Synthesis of the knowledge evidenced

To evaluate the studies regarding Levels of Evidence, the classification was used in seven levels, being considered as level 1 (stronger) the evidence from a systematic review or meta-analysis of randomized clinical trials; level 2, evidence from well-delineated randomized clinical trials; level 3, evidence from well-delineated clinical trials without randomization; level 4, evidence from well-delineated cohort and case-control studies; level 5, evidence from a systematic review of descriptive and qualitative studies; level 6, evidence from a single descriptive or qualitative study; and level 7 (weaker), evidence from expert opinion⁽¹⁰10 Melnyk BM, Fineout-Overholt E. Evidence-based practice in nursing & healthcare: a guide to best practice. Philadelphia: Lippincott Williams & Wilkins; 2011. Chapter 1: Making the case evidence-basead practice and cultivating a spirit of inquiry, p. 3-24.⁾.

RESULTS

In the first analysis of the 512 studies, after reading the title and abstract, articles that did not address lawsuits in health and duplicate articles were excluded (n=414). In the second analysis, through reading in full (n=98), 53 studies that did not portray the subject and 18 that were theoretical articles, book chapter, theses and dissertations were excluded. Three studies that did not appear in the selection by the databases were included through manual search, resulting in 30 articles selected for this study (Figure 1).

The years with the greatest number of publications were 2012, 2013, 2014 and 2015 with four publications in each year and in 2016 five studies were published. Regarding the language, 24 were published in Brazilian Portuguese, four in English and two in Spanish.

In relation to the area of the authors, 15 were from Pharmacy, 14 Nursing, nine Medicine, six Law, three Economics, among others.

Regarding the method adopted by the studies, all were descriptive studies, with a quantitative approach (50%), qualitative (16.7%) and quantitative/qualitative (33.3%), all with Level of Evidence 6.

Twenty-seven studies were found in Brazil, where medication lawsuits were predominant (74%). Afterwards, there were studies (26%) that described requests for surgical procedures, hospitalization at the Intensive Care Unit, medical error, consultations and exams, home care, surgeries, food supplements, orthoses and prostheses, hospitalization for psychiatric treatment, SPA hospitalization, request for vaccines, supplies for diabetics, home hospitalization, demand for hospital transportation, among others.

In international studies, lawsuits were found for medications in Colombia (n=1), benefit coverage in Argentina (n=1) and hospitalization for psychiatric treatment in Spain (n=1).

Synthesis of studies were categorized into lawsuits requiring medication (Chart 1) and lawsuits for surgical procedures, hospitalization at the Intensive Care Unit, medical error, consultations and examinations, surgical materials, home hospitalization, among others (Chart 2). Synthesis of studies is presented in the Charts in alphabetical order of authors.

DISCUSSION

The public health system in Brazil comprises a set of lawsuits and services, however, it is noted that most of the studies published on the types of judicialization of health lawsuits deal with access to medicines.

Lawsuits for medicines have been taking place even after the creation in 1996 of public policy, which promises the free and universal dispensation of medications. From this perspective, it is worth mentioning that lawsuits also occur with medications contained in the Relação Nacional de Medicamentos Essenciais (RENAME - National Relation of Essential Medicines). This practice needs to be reviewed in light of the fact that most of lawsuits are accompanied by a medical professionals’⁽³3 Oliveira MRM, Delduque MC, Sousa MF, Mendonça AVM. Mediation : a way to disjudialize health. Temp Act Saúde Col [Internet]. 2016 [cited 2019 Mar 12];10(1):169-77. Available from: http://dx.doi.org/10.18569/tempus.v10i1.1860 Portuguese.
http://dx.doi.org/10.18569/tempus.v10i1.... ⁾.

In this sense, 21 articles involved access to medications⁽¹¹11 Biehl J, Socal MP, Amon JJ. The judicialization of health and the quest for state accountability: evidence from 1,262 lawsuits for access to medicines in southern Brazil. Health Hum Rights [Internet]. 2016 [cited 2019 Mar 12];18(1):209-20. Available from: https://pdfs.semanticscholar.org/b787/0d87ead2460a5cb8c41059e90bf7236a271e.pdf?_ga=2.169565409.1195865572.1552323956-1942654150.1552323956
https://pdfs.semanticscholar.org/b787/0d...

12 Cabral I, Rezende LF. [Analysis of individual lawsuits on supplying journal in São João da Boa Vista, São Paulo, Brazil]. R Dir Sanit [Internet]. 2015 [cited 2019 Mar 12];16(1):59-77. Available from: https://doi.org/10.11606/issn.2316-9044.v16i1p59-77 Portuguese.
https://doi.org/10.11606/issn.2316-9044....

13 Chieffi AL, Barata RB. [“Judicialization” of public health policy for journal of medicines]. Cad Saúde Pública [Internet]. 2009 [cited 2019 Mar 12];25(8):1839-49. Available from: http://dx.doi.org/10.1590/S0102-311X2009000800020 Portuguese.
http://dx.doi.org/10.1590/S0102-311X2009...

14 Chieffi AL, Barata RCB. Legal suits: pharmaceutical industry strategies to introduce journal drugs in the brazilian public healthcare system. Rev Saúde Pública [Internet]. 2010 [cited 2019 Mar 12];44(3). Available from: http://dx.doi.org/10.1590/S0034-89102010000300005
http://dx.doi.org/10.1590/S0034-89102010...

15 Coelho TL, Ferré F, Neto OHC, Assis AF, Cherchiglia ML, Andrade EIG. Legal and health variations in drug litigation injunctions granted in Minas Gerais. Rev Saúde Pública [Internet]. 2014 [cited 2019 Mar 12];48(5):808-16. Available from: http://dx.doi.org/10.1590/S0034-8910.2014048005286
http://dx.doi.org/10.1590/S0034-8910.201...

16 Leitão LCA, Silva PCDD, Simões AEO, Barbosa IC, Pinto MEB, Simões MODS. Analysis of medicine procurement lawsuits in the state journal Paraíba, Brazil. Saúde Soc [Internet]. 2016 [cited 2019 Mar 12];25(3):801-8. Available from: http://dx.doi.org/10.1590/S0104-12902016153819
http://dx.doi.org/10.1590/S0104-12902016...

17 Lopes LC, Nascimento SMS, Camargo IA, Barberato-Filho S, Del Fiol FDS, Osorio-de-Castro CGS. Biological drugs for the treatment of psoriasis in a public health system. Rev Saúde Pública [Internet]. 2014 [cited 2019 Mar 12];48(4):651-61. Available from: http://dx.doi.org/10.1590/S0034-8910.2014048005109
http://dx.doi.org/10.1590/S0034-8910.201...

18 journal MAA, Acurcio FDA, Brandão CMR, Faleiros DR, Guerra Jr AA, Cherchiglia ML et al. Judicialization of access to medicines in minas gerais state, southeastern brazil. Rev de Saúde Pública [Internet]. 2011 [cited 2019 Mar 12];45(3). Available from: http://dx.doi.org/10.1590/S0034-89102011005000015
http://dx.doi.org/10.1590/S0034-89102011...

19 Medeiros M, Diniz D, Doederlein S, Ida V. [The thesis of judicialization of health journal by the elites: medication for mucopolysaccharidosis]. Ciência & Saúde Coletiva [Internet]. 2013 [cited 2019 Mar 12];18(4):1089-98. Available from: http://dx.doi.org/10.1590/S1413-81232013000400022 Portuguese.
http://dx.doi.org/10.1590/S1413-81232013...

20 Neto OHC, Acurcio FA, Machado MAA, Ferré F, Barbosa FLV, Cherchiglia ML, et al. Doctors, lawyers and pharmaceutical industry on health journal in Minas Gerais, Southeastern Brazil. Rev Saúde Pública [Internet]. 2012 [cited 2019 Mar 12];46(5):784-90. Available from: http://dx.doi.org/10.1590/S0034-89102012000500004
http://dx.doi.org/10.1590/S0034-89102012...

21 Pepe VLE, Ventura M, Sant’ana JMB, Figueiredo TA, Souza VDRD, Simas L, Osorio-de-Castro CGS. &journal;#91;Characterization of lawsuits for the supply of “essential” medicines in the state of rio de janeiro, brazil]. Cad Saúde Pública [Internet]. 2010 [cited 2019 Mar 12];26(3):461-71. Available from: http://dx.doi.org/10.1590/S0102-311X2010000300004 Portuguese.
http://dx.doi.org/10.1590/S0102-311X2010...

22 Pereira JG, Pepe VLE. &journal;#91;Judicial access to medicine in paraná: applying a methodological model for lawsuit analysis and monitoring]. R Dir Sanit [Internet]. 2014 [cited 2019 Mar 12];15(2):30-45. Available from: https://doi.org/10.11606/issn.2316-9044.v15i2p30-45 Portuguese.
https://doi.org/10.11606/issn.2316-9044....

23 Portilla-Pinzón A, López JJ, Montoya-Cañon M, Machado-Alba JE. [Evaluation of prescriptions authorized between 2010 journal 2011 through judicial protection in Bogotá]. Rev Fac Med [Internet]. 2016 [cited 2019 Mar 12];64(4):679-85. Available from: http://dx.doi.org/10.15446/revfacmed.v64n4.53574 Spanish.
http://dx.doi.org/10.15446/revfacmed.v64...

24 Provin MP, Leite SN, Amaral RG. Social inequalities in lawsuits for drugs. Braz J Pharm Sci [Internet]. 2013 [cited 2019 Mar 12];49(3):465-74. Available from: http://dx.doi.org/10.1590/S1984-82502013000300008
http://dx.doi.org/10.1590/S1984-82502013...

25 Ramos KA, Ferreira ASD. [Analysis of the demand for medicines journal off label use through lawsuits in the state health secretariat of minas gerais]. R Dir Sanit [Internet]. 2013 [cited 2019 Mar 12];14(1):98-121. Available from: https://doi.org/10.11606/issn.2316-9044.v14i1p98-121 Portuguese.
https://doi.org/10.11606/issn.2316-9044....

26 Sant‘ana JMB, Pepe VLE, Figueiredo TA, Osorio-de-Castro CGS, Ventura M. Rational therapeutics: health-related elements in lawsuits journal medicines. Rev Saúde Pública [Internet]. 2011 [cited 2019 Mar 12];45(4). Available from: http://dx.doi.org/10.1590/S0034-89102011005000042
http://dx.doi.org/10.1590/S0034-89102011...

27 Silva EM, de Almeida, KC, Pessoa GSC. [Analysis of drug expenditure with judicialization journal the federal district, brazil]. Cad Ibero-Amer Dir Sanit [Internet]. 2017 [cited 2019 Mar 12];6(1):112-26. Available from: http://dx.doi.org/10.17566/ciads.v6i1.358 Portuguese.
http://dx.doi.org/10.17566/ciads.v6i1.35...

28 Souza ÍP, Bellato R, Araújo LFS, Almeida KBB, Nepomuceno MAS, Mufato LF. [Right to health in the court journal justice: demand for oncology drugs]. Rev RENE [Internet]. 2012 [cited 2019 Mar 12];13(4):919-28. Available from: https://www.redalyc.org/pdf/3240/324027983022.pdf Portuguese.
https://www.redalyc.org/pdf/3240/3240279...

29 Stamford A, Cavalcanti M. Legal decisions on access to medicines in journal northeastern brazil. Rev Saúde Pública [Internet]. 2012 [cited 2019 Mar 12];46(5). Available from: http://dx.doi.org/10.1590/S0034-89102012000500005
http://dx.doi.org/10.1590/S0034-89102012...

30 Vieira FS, Zucchi P. Distortions to national drug policy caused by lawsuits journal brazil. Rev Saúde Pública [Internet]. 2007 [cited 2019 Mar 12];41(2). Available from: http://dx.doi.org/10.1590/S0034-89102007000200007
http://dx.doi.org/10.1590/S0034-89102007... ^-3131 Wang DWL, Vasconcelos NP, Oliveira VE, Terrazas FV. [The impacts of health care judicialization journal the city of Sao Paulo: public expenditure and federal organization]. Rev Adm Pública [Internet]. 2014 [cited 2019 Mar 12];48(5):1191-1206. Available from: http://dx.doi.org/10.1590/0034-76121666 Portuguese.
http://dx.doi.org/10.1590/0034-76121666... ⁾, in which six articles were required medications, such as Adalimumab and Etanercept⁽¹⁴14 Chieffi AL, Barata RCB. Legal suits: pharmaceutical industry strategies to introduce journal drugs in the brazilian public healthcare system. Rev Saúde Pública [Internet]. 2010 [cited 2019 Mar 12];44(3). Available from: http://dx.doi.org/10.1590/S0034-89102010000300005
http://dx.doi.org/10.1590/S0034-89102010... ^,1515 Coelho TL, Ferré F, Neto OHC, Assis AF, Cherchiglia ML, Andrade EIG. Legal and health variations in drug litigation injunctions granted in Minas Gerais. Rev Saúde Pública [Internet]. 2014 [cited 2019 Mar 12];48(5):808-16. Available from: http://dx.doi.org/10.1590/S0034-8910.2014048005286
http://dx.doi.org/10.1590/S0034-8910.201... ^,1717 Lopes LC, Nascimento SMS, Camargo IA, Barberato-Filho S, Del Fiol FDS, Osorio-de-Castro CGS. Biological drugs for the treatment of psoriasis in a public health system. Rev Saúde Pública [Internet]. 2014 [cited 2019 Mar 12];48(4):651-61. Available from: http://dx.doi.org/10.1590/S0034-8910.2014048005109
http://dx.doi.org/10.1590/S0034-8910.201... ^,1818 journal MAA, Acurcio FDA, Brandão CMR, Faleiros DR, Guerra Jr AA, Cherchiglia ML et al. Judicialization of access to medicines in minas gerais state, southeastern brazil. Rev de Saúde Pública [Internet]. 2011 [cited 2019 Mar 12];45(3). Available from: http://dx.doi.org/10.1590/S0034-89102011005000015
http://dx.doi.org/10.1590/S0034-89102011... ^,2020 Neto OHC, Acurcio FA, Machado MAA, Ferré F, Barbosa FLV, Cherchiglia ML, et al. Doctors, lawyers and pharmaceutical industry on health journal in Minas Gerais, Southeastern Brazil. Rev Saúde Pública [Internet]. 2012 [cited 2019 Mar 12];46(5):784-90. Available from: http://dx.doi.org/10.1590/S0034-89102012000500004
http://dx.doi.org/10.1590/S0034-89102012... ^,2222 Pereira JG, Pepe VLE. &journal;#91;Judicial access to medicine in paraná: applying a methodological model for lawsuit analysis and monitoring]. R Dir Sanit [Internet]. 2014 [cited 2019 Mar 12];15(2):30-45. Available from: https://doi.org/10.11606/issn.2316-9044.v15i2p30-45 Portuguese.
https://doi.org/10.11606/issn.2316-9044.... ⁾, indicated for the treatment of rheumatoid arthritis. Four articles demanded medications, such as Infliximabe⁽¹⁴14 Chieffi AL, Barata RCB. Legal suits: pharmaceutical industry strategies to introduce journal drugs in the brazilian public healthcare system. Rev Saúde Pública [Internet]. 2010 [cited 2019 Mar 12];44(3). Available from: http://dx.doi.org/10.1590/S0034-89102010000300005
http://dx.doi.org/10.1590/S0034-89102010... ^,1717 Lopes LC, Nascimento SMS, Camargo IA, Barberato-Filho S, Del Fiol FDS, Osorio-de-Castro CGS. Biological drugs for the treatment of psoriasis in a public health system. Rev Saúde Pública [Internet]. 2014 [cited 2019 Mar 12];48(4):651-61. Available from: http://dx.doi.org/10.1590/S0034-8910.2014048005109
http://dx.doi.org/10.1590/S0034-8910.201... ^,2020 Neto OHC, Acurcio FA, Machado MAA, Ferré F, Barbosa FLV, Cherchiglia ML, et al. Doctors, lawyers and pharmaceutical industry on health journal in Minas Gerais, Southeastern Brazil. Rev Saúde Pública [Internet]. 2012 [cited 2019 Mar 12];46(5):784-90. Available from: http://dx.doi.org/10.1590/S0034-89102012000500004
http://dx.doi.org/10.1590/S0034-89102012... ^,2222 Pereira JG, Pepe VLE. &journal;#91;Judicial access to medicine in paraná: applying a methodological model for lawsuit analysis and monitoring]. R Dir Sanit [Internet]. 2014 [cited 2019 Mar 12];15(2):30-45. Available from: https://doi.org/10.11606/issn.2316-9044.v15i2p30-45 Portuguese.
https://doi.org/10.11606/issn.2316-9044.... ⁾, also recommended for rheumatoid arthritis. Rituximab⁽¹⁶16 Leitão LCA, Silva PCDD, Simões AEO, Barbosa IC, Pinto MEB, Simões MODS. Analysis of medicine procurement lawsuits in the state journal Paraíba, Brazil. Saúde Soc [Internet]. 2016 [cited 2019 Mar 12];25(3):801-8. Available from: http://dx.doi.org/10.1590/S0104-12902016153819
http://dx.doi.org/10.1590/S0104-12902016... ^,2222 Pereira JG, Pepe VLE. &journal;#91;Judicial access to medicine in paraná: applying a methodological model for lawsuit analysis and monitoring]. R Dir Sanit [Internet]. 2014 [cited 2019 Mar 12];15(2):30-45. Available from: https://doi.org/10.11606/issn.2316-9044.v15i2p30-45 Portuguese.
https://doi.org/10.11606/issn.2316-9044.... ^,2525 Ramos KA, Ferreira ASD. [Analysis of the demand for medicines journal off label use through lawsuits in the state health secretariat of minas gerais]. R Dir Sanit [Internet]. 2013 [cited 2019 Mar 12];14(1):98-121. Available from: https://doi.org/10.11606/issn.2316-9044.v14i1p98-121 Portuguese.
https://doi.org/10.11606/issn.2316-9044.... ^,2828 Souza ÍP, Bellato R, Araújo LFS, Almeida KBB, Nepomuceno MAS, Mufato LF. [Right to health in the court journal justice: demand for oncology drugs]. Rev RENE [Internet]. 2012 [cited 2019 Mar 12];13(4):919-28. Available from: https://www.redalyc.org/pdf/3240/324027983022.pdf Portuguese.
https://www.redalyc.org/pdf/3240/3240279... ⁾ was indicated for treatment of non-Hodgkin’s lymphoma. These medicines are present in RENAME, but the population has been finding difficulties in accessing these medicines, in which the pharmaceutical assistance policy presents flaws in the programming, acquisition and distribution of medications⁽¹⁸18 journal MAA, Acurcio FDA, Brandão CMR, Faleiros DR, Guerra Jr AA, Cherchiglia ML et al. Judicialization of access to medicines in minas gerais state, southeastern brazil. Rev de Saúde Pública [Internet]. 2011 [cited 2019 Mar 12];45(3). Available from: http://dx.doi.org/10.1590/S0034-89102011005000015
http://dx.doi.org/10.1590/S0034-89102011... ⁾.

On the other hand, requests for non-standard and high-cost medications can be influenced by the pharmaceutical industry in partnership with prescribing doctors. And the irrational and unnecessary use of new medications, often without scientific evidence, aiming at the future standardization of this technology, and may be a factor that promotes an increase in the demand for medicines and high expenses with judicialization⁽⁴¹41 Soares JCRS, Deprá AS. [Dangerous liaisons: the pharmaceutical industry, patients associations and the legal battles for access to medicines]. Physis [Internet]. 2012 [cited 2019 Mar 12]; Available from: http://dx.doi.org/10.1590/S0103-73312012000100017 Portuguese.
http://dx.doi.org/10.1590/S0103-73312012... ⁾.

In order to standardize a new medication, it is necessary, in addition to the safety factors, effectiveness and effectiveness, that these are the best option in relation to the cost, because thus more people would have access⁽⁴²42 Medici AC. Judicialização, integralidade e financiamento da saúde. Diagn Trat [Internet]. 2010 [cited 2019 Mar 12];15(2):81-87. Available from: https://www.researchgate.net/publication/280612164_Judicializacao_Integralidade_e_Financiamento_da_Saude_no_Brasil Portuguese.
https://www.researchgate.net/publication... ⁾.

Judicialization of health does not only include access to medicines. One of the articles found in this review refers to civil and criminal cases on medical error, in which the specialty with the greatest number of cases was Gynecology/Obstetrics⁽³⁴34 Gomes TR. &journal;#91;The medical error under the eyes of the Judiciary: an investigation at the court of justice of federal district and territories]. Cad Íbero-Amer Dir Sanit [Internet]. 2017 [cited 2019 Mar 12];6(1):72-85. Available from: http://dx.doi.org/10.17566/ciads.v6i1.362 Portuguese.
http://dx.doi.org/10.17566/ciads.v6i1.36... ⁾. Braga, Vieira and Martins⁽⁴³43 Braga IFA, Vieira KO, Martins TGS. Civil liability of the ophthalmologist in the são paulo court of appeals. Einstein [Internet]. 2017 [cited 2019 Mar 12];15(1):40-4. Available from: http://dx.doi.org/10.1590/S1679-45082017AO3781
http://dx.doi.org/10.1590/S1679-45082017... ⁾ performed a study in which there was a tendency to increase lawsuits in the ophthalmological area, and a predominance of lawsuits in surgical ophthalmologic procedures.

In a recent study in the United States, medical errors are classified as the third leading cause of death, where data on mortality in the country were analyzed for eight years, noting that more than 250,000 deaths per year are attributed to errors⁽⁴⁴44 Makary MA, Daniel M. Medical Error - the third leading cause of journal in the US. BMJ [Internet]. 2016 [cited 2019 Mar 12];353:i2139. Available from: http://dx.doi.org/10.1136/bmj.i2139
http://dx.doi.org/10.1136/bmj.i2139... ⁾. However, the study detected little scientific publication on the judicialization of medical error.

It is noteworthy that the types of lawsuits outside Brazil were demands on coverage of benefits in Argentina, medicines, such as antiepileptics in Colombia and hospitalization for psychiatric treatment in Spain. Given the lack of world literature on the proposed theme, it is questioned whether health judicialization is a specific problem of greater transparency in Brazilian public health, or if the scarce publication is due to scientific omission, considering that nations worldwide are subject to such structural-political complications.

Study limitations

The limitation of this study was that the selected databases were only those accessible to researchers of this study, and the extension of the search in other paid databases could contemplate other types of studies in other realities.

Contributions for the area of Public Policy

The study contributes to the characterization of health judicial demands, enabling public managers to detect failures in distribution and acquisition of medicines, which can avoid lawsuits for standardized medications. On the other hand, the study boosts reflection on the scientific evidence of requests before lawsuits are judged through consultations with doctors, in order to avoid prescriptions of non-standardized technologies, especially in medicines, and can thus reduce the quantity of lawsuits in health.

CONCLUSION

This integrative review found that access to the medication was the most obvious type of lawsuit. However, even with the increase in judicialization of health, what resulted in the main limitation of this study was the scarcity of literature on the subject. At the international level, the lack of discussion on the subject was even more evident, revealing that the judicialization of access to medicines may indicate a reality that is characteristic of Brazil. Thus, it is evident the need to produce new studies on the reason for requesting standardized medications through lawsuits. This indicates possible management failures in the acquisition and distribution of these medications and the reason for the medical prescription of non-standard medications, which may indicate a presumed lack of knowledge of prescribers about medications present in the SUS lists. This fact can also indicate the induction of prescription by the pharmaceutical industry, aiming at the inclusion of new medications.

REFERENCES

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