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  • Claudio Cordovil Oliveira

Upstream Judicialization: The Possible Revolution?

Atualizado: Jan 14

In Brazil, since the approval of the Federal Constitution in 1988, health "is a right of all and a duty of the State". A critical component of this is that the Constitution guarantees the development of a universal, comprehensive, egalitarian and free public health system in Brazil.


This system is now called the "Unified Health System" (or in Portuguese ‘Sistema Único de Saúde’, or SUS), it was designed to serve all Brazilians in a non-discriminatory and equitable way (AITH, 2014). It is one of the few public health systems in the world that has accepted the challenge of providing universal coverage to more than 200 million inhabitants. And this is certainly a commendable ambition.


The integrality of public health services, originally conceived as a priority for preventive actions, presupposes the notion that the public system must offer comprehensive care, which includes health promotion, prevention and recovery actions and encomposses primary, secondary and tertiary health care services. Integrality also includes pharmaceutical access, as well as recovery and rehabilitation services. (Id. Ibid) This is one of the most important principles which guide the SUS, even if it seems problematic in terms of its definition.


However, in a middle income country with continental dimensions, it is natural that such a formally recognized right conflicts with the state's inability to meet the needs of large population groups. This is especially true in the context of an underfunded public health system, a side effect of the neoliberal prescriptions. In this way, the conditions for the perfect storm are created where some extremely prolific law professionals in scientific publications have identified in court that treatments for rare diseases, which are often very high-cost, pose a threat to the equity of the public health system.


Thus, a phenomenon that has aroused great interest from the academic sector in the country, especially in the field of Law and Public Health, is the boom of legal actions in health (judicialization in health), claiming a need for better access to health services and medicines. In 2016, the Ministry of Health spent approximately US$ 316 million on drug purchases through lawsuits. With regard to medicines, about 90% of associated costs were designated to ensuring that they comply with judicial decisions regarding therapies for rare diseases.


In an attempt to halt what it sees as the true evasion of public resources and to redefine the ambiguous concept of “integrality”, the Federal Executive Branch obtained in the National Congress the approval of Law 12,401 / 2012, of 04/28/2011, which, in practice, created an agency with powers similar to those of the National Institute of Care and Health Excellence in England and Wales. The Brazilian agency, called the National Commission for the Incorporation of Health Technologies - CONITEC, was created with the competence to participate in decision-making processes on medicines that will be incorporated (reimbursed) into the Unified Health System, based on Health Technology Assessments (HTA) and principles of Based Medicine in Evidence. The final word, however, remains with the Minister of State for Health and his direct advisor who occupies the National Secretariat of Science and Technology in Health. It is also the responsibility of CONITEC to develop clinical guidelines as healthcare prioritization tools.


One of the reasons for its creation is unequivocally defined by some of its executives at the time of its creation. They mentioned that the Commission's objectives include reducing litigation and changing the negative image that courts have of the public health system (CAPUCHO et al., 2011; PETRAMALE, 2011).

Despite such noble efforts, recent studies revealed the absence of judicial deference to health prioritization decisions offered by HTA agencies such as CONITEC. (WANG et al., 2020; CONSELHO NACIONAL DE JUSTIÇA, 2018). According to Wang et al. , "the creation of a new HTA system has not changed the way in which judicial claims for health treatments are decided by the courts in Brazil".


And these authors conclude their article with a noticeable dismay. “The Judiciary still considers that individual needs and the right of health trump priority-setting decisions, even when they are made through HTA". A very peculiar way to see distributive justice indeed.


In the center of the dispute for right to health in Brazil nowadays there is a false dilemma between collective needs (as considered in the Population Health framing of this issue) and individual needs, supposedly claimed by rare disease patients, the vast majority of those who demand high-cost drugs to the federal executives.


Regarding the judicialization of health, Law and Public Health experts' opinions differ consistently. Basically, these positions are divided into two antagonistic fields. One of them, with notable (and worrying) support from the mainstream Brazilian press, sees the judicialization of public health as the triumph of the “haves” over the “have-nots”. According to this narrative, the urban elites drive the judicialization seeking high-cost drugs not present in the national formularies in a sort of “Robin Hood in reverse” (COLUCCI, 2014).


It is important to highlight that the evidence for this perspective is not so robust and conclusive. To this stream of qualified opinions the solution to this issue would be, to put it bluntly, the strict observance of the Evidence Based Medicine agenda fostered by HTA bodies in the judicial decisions. This would all sound perfect if the literature concerning Pharmacoeconomics had not already shown, in a robust way, that conventional HTAs are definitely not an adequate to decide, on a exclusive basis, about rare diseases and orphan drugs (NESTLE-PARR et al, 2018; CARDOSO e CORDOVIL-OLIVEIRA, 2019).


In practice, the wild application of the HTA commandments in the Brazilian deliberations on this therapeutic category will result in non-reimbursement of them by public health systems. So, our patient-citizen-consumer will see no alternative but to go to court to regain his right to health, supposedly denied.


Another stream of opinions (shared by me and Aith, the Brazilian researchers of the SPIN team) argues that the judicialization becomes an alternate path to citizenship in an unfinished democracy project where all administrative mechanisms fail. By this logic it would be a powerful tool to hold the State accountable for workable infrastructures. So, judicialization would be a kind of para-infrastructure to claim health rights.


It is indeed a dispute with a strong agonistic character, which is well portrayed in the report of a truly obnoxious so to speak academic freak show, where Biehl (2016a, English version) were assigned involuntarily to a pathetic role. It is Biehl that inform us about their impressions about this social and academic drama:

[A] hybrid government of social protection and market expansion there is underway a tabulation of power, which ultimately serves to “de-poor” people seeking care, working infrastructures and justice while also shoring up state politics as usual.


It would be interesting at this moment to highlight that the constellation of values ​​that guided public health in an international perspective has suffered a major upheaval since the 1990s with the 'revolution' represented by neoliberalism in the relations between the State, civil society. and large corporations as well as its prescription for privatization, deregulation of markets and public spending cuts.


As a representative of this thinking concerning “global health”, we could cite the publication by the World Bank of the World Development Report entitled Investing in Health (1993). It is there that a certain emphasis on the 'improvement' of public health spending begins to be seen as provided by managerialism and the prioritization of cost-effective interventions in a evident strategy to disrupt the comprehensive Public Health programs previously in operation.


Primary health care, which conceived the Nation State as the leader of health policies, leaves the scene. The private sector goes to the main stage with the banner of "access to medicines'' as a panacea for the problems faced by global health. Welcome to the era of pharmaceuticalization and privatization of public health and where the civil society paradigm fades out in politics. In this context, patient organizations act conveyor belts of the meritorious interests of the pharmaceutical industry and others not so ethical. Access to treatments becomes one of the central components of global health activism in a scene where patients living with rare diseases are important players.


In this peculiar contemporary discursive formation, observed especially in countries of the Global South (and especially in Brazil), an unusual combination provided by the judicialization of health is shown:


The penetration of market principles in the provision of care is unexpectedly aligned to the legal subject of rights (...) The economic subject represented by the rational actor model (...) is at the same time subject to legal rights. (...) The right to life is claimed somewhere between the clinic, the court and the market (Biehl, 2016b, English version).


On the other hand, the combination of judicialization and pharmaceuticalization of public health created a peculiar situation, observed with some irony by Biehl (2016b) that argues that in these debates “social roles and institutional positions were out of place”.


The Judiciary is acting as a source of pharmacy, the public defender as a physician, the physician as an activist, the patient association as legal counsel; the patient-citizen was becoming a consumer, and cost-cutting public officers had kidnapped the discourse on equity.


Given that situation, we could ask: How to understand this new legal-political order that the Global South put before us? This will be one of our tasks in this transnational Social Pharmaceutical Innovation (SPIN) project.


Written by: Claudio Cordovil

References


AITH, F, et al. Os princípios da universalidade e integralidade do SUS sob a perspectiva da política de doenças raras e da incorporação tecnológica. R. Dir. sanit. [Internet]. July 11 2014 [access in December 17 2020];15(1):10-39. Link: https://www.revistas.usp.br/rdisan/article/view/82804


BIEHL, J. The postneoliberal fabulation of power: on statecraft, precarious infrastructures, and public mobilization in Brazil. American Ethnologist, 43(3):437-450, 2016a.


________. Patient-citizen-consumers: judicialization of health and metamorphosis of biopolitics. Lua Nova. v. 98, p. 77-105. 2016b.


CAPUCHO, H. et al. Incorporation of technologies in health in Brazil: a new model for the Brazilian public health system (sistema Único de Saúde - SUS). Bol. Inst. Saúde, 215, 2011.


CARDOSO, J.V. ; CORDOVIL-OLIVEIRA, C. Pleitos vitais: o que o STF deveria saber sobre a Medicina Baseada em Evidências. JOTA. 2019. Link: https://www.jota.info/paywall?redirect_to=//www.jota.info/opiniao-e-analise/artigos/pleitos-vitais-o-que-o-stf-deveria-saber-sobre-a-medicina-baseada-em-evidencias-21052019

Acessed on December 17 2020.



COLUCCI, C. Judicialização na saúde faz desigualdade avançar, dizem especialistas. Folha de S. Paulo. 29 mar. 2014. Disponível em: https://m.folha.uol.com.br/seminariosfolha/2014/03/1432517-judicializacao-na-saude-faz-desigualdade-avancar-dizem-especialistas.shtml#:~:text=Para%20a%20pesquisadora%20Lygia%20Bahia,com%20ou%20sem%20efetividade%20comprovada. Acesso em 17 dez 2020.

CONSELHO NACIONAL DE JUSTIÇA. Judicialização da Saúde: Perfil das Demandas, Causas e Propostas de Solução. Instituto de Ensino e Pesquisa - Insper. 2018.

Link: https://www.cnj.jus.br/wp-content/uploads/2019/03/66361404dd5ceaf8c5f7049223bdc709.pdf. Acesso em 17 dez 2020.


NESTLE-PARR, Sandra et al. Challenges in Research and Health Technology Assessment of Rare Disease Technologies: Report of the ISPOR Rare Disease Special Interest Group. Value in Health, v. 21 , p. 493-500. 2018.

PETRAMALE, C. Nova Comissão Nacional de Incorporação de Tecnologias de Saúde e impacto ao Sistema Único de Saúde. Rev. Saude Publica, 45 (5) (2011), pp. 993-996.


WANG, D. et al. Health technology assessment and judicial deference to priority-setting decisions in healthcare: Quasi-experimental analysis of right-to-health litigation in Brazil, Social Science & Medicine, Volume 265, p. 2020,


WORLD BANK. “World Bank. 1993. World Development Report 1993 : Investing in Health. New York: Oxford University Press.

Link: https://openknowledge.worldbank.org/handle/10986/5976 Accessed in December, 17 2020.

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