Organization of public entities to attend to the judicialization of access to medications in the state of Santa Catarina, Brazil

Caetano, Cristiana Ropelatto; Matheus, Filipe Carvalho; Diehl, Eliana Elisabeth

doi:10.1590/1413-812320212611.32092020

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ARTICLE • Ciênc. saúde coletiva 26 (11) • Nov 2021 • https://doi.org/10.1590/1413-812320212611.32092020 copy

Organization of public entities to attend to the judicialization of access to medications in the state of Santa Catarina, Brazil

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

This study describes the organization of the State of Santa Catarina (SC), Brazil, to attend to the judicialization of access to medications from the early 2000s to 2018. Document analysis and interviews with representatives of the Executive, the Judiciary, the State Attorney General Office (PGE, Procuradoria Geral do Estado/SC), the Public Defender’s Office of the State of SC and the Public Prosecutor’s Office of the State of SC (MPSC, Ministério Público de SC) were performed. The Judiciary, the PGE/SC and the MPSC organized themselves to address the phenomenon. Initially, the State Health Secretariat did not have an organization to attend to the judicialization; with the increase in the number of lawsuits, it created sectors, routines and systems, and at the end of 2018 there was a specific Administrative Management and sector. The main measures used were: public hearing of the Federal Supreme Court, statements by the National Justice Council, Incident of Resolution of Repetitive Demands, State Monitoring and Resolution Committee for Health Care Demands in SC, Center for Repetitive Actions in Health Care, Multidisciplinary Judicial Support Commission and the Technical Support Center. The judicialization of access to medications in SC has not yet been resolved, since all the implemented measures have not prevented the increasing rise in expenses with lawsuits.

Key words:
Health’s Judicialization; Access to medications; Executive; Judiciary; Public prosecutor’s office

	Organs	Sector / Service / Region of Jurisdiction
Executive power	Santa Catarina State Health Secretariat (SES/SC)	Multidisciplinary Judicial Support Commission (COMAJ, Comissão Multidisciplinar de Apoio Judicial)
		Legal Asset Management (GEJUD Gerência de Bens Judiciais)
		Pharmaceutical Assistance Board (DIAF, Diretoria de Assistência Farmacêutica)
		Technical Support Center (NAT-JUS, Núcleo de Apoio Técnico)
Judicial power	State Justice	District of Presidente Getúlio
	State Justice	District of Rio do Oeste
	Federal Justice	State Monitoring and Resolution Committee for Health Care Demands in SC (COMESC, Comitê Estadual de Monitoramento e Resolução das Demandas de Assistência da Saúde de Santa Catarina)
Essential Functions of Justice	State Attorney General Office (PGE/SC)	Center for Repetitive Actions in Health Care (NARAS, Núcleo de Ações Repetitivas de Assistência à Saúde)
	Public Defender’s Office of the State of Santa Catarina (DP/SC)	Rio do Sul Center
	Public Prosecutor’s Office of the State of Santa Catarina (MPSC)	Operational Support Center for Human Rights and the Third Sector

Level	Measure	Entity	Year	Status	Summary of content or assignments/activities	Reference
Nacional	Public Health Hearing	STF	2009	Current	Considering the case that generated the lawsuit, its analysis is guided by: . Requirement of scientifically substantiated evidence . Application of evidence-based medicine (EBM) and Clinical Protocols and Therapeutic Guidelines (CPTG) adopted by the Unified Health System . Existence of public policy . User health need . Verification of drug registration . The reservation of what is possible (scarcity of resources) does not eliminate the obligation of public entities to provide the requested service	14
	Recommendation n. 31	CNJ	2010	Current	Recommendations to the Courts of Justice (State and Federal Regional): . Establish accords until December 2010 for the technical support of physicians and pharmacists, in order to assist magistrates in decision-making (consideration of clinical issues) . That magistrates: (a) instruct actions, whenever possible, with medical reports containing the description of the disease (including the International Classification of Diseases code), the prescription of drugs by generic name or active ingredient and with exact dose; (b) avoid authorization for the supply of medications without registration with the National Health Surveillance Agency (Anvisa, Agência Nacional de Vigilância Sanitária) or in an experimental phase; (c) listen to managers before considering urgent measures; among others . Encourage visits by magistrates to instances of social control of the Unified Health System (SUS), as well as to SUS health services units Recommendations to the National School for the Training and Improvement of Magistrates (Escola Nacional de Formação e Aperfeiçoamento de Magistrados), National School for the Training and Improvement of Labor Magistrates (Escola Nacional de Formação e Aperfeiçoamento de Magistrados do Trabalho) and the Federal and State Magistrates Schools: . Include health law legislation in training courses . Encourage joint events (judges, members of the public prosecutor’s office and managers) of studies in the area of health, seeking dialogue on the subject	15
	Resolution n. 107 - establishes the National Judiciary Forum (Health Forum)	CNJ	2010	Current	Responsibilities of the National Forum: . Monitoring of lawsuits involving, for example, the supply of medications, products or supplies in general, treatments and provision of hospital beds . Monitoring of lawsuits related to SUS . Proposition of concrete and normative measures aimed at: (a) optimization of procedural routines, organization and structuring of specialized judicial units; (b) prevention of legal conflicts and the definition of strategies in matters of health law; among others Executive committees will be created at the National Forum The National Council of Justice, in order to ensure the proper performance of the National Forum’s attributions, may sign terms of technical cooperation agreements or accords with public and private organs and entities, whose institutional activities are aimed at finding a solution to conflicts	16
Nacional	I, II and III National Health Journey (or Right to Health Journeys)	CNJ	2014 2015 2019	Current	- I Journey approved 45 statements, 14 of which were directly related to medications, including: . The PCDT organizes the pharmaceutical provision, without limiting it - revoked at the III Journey . The processing of lawsuits in which medications not registered by Anvisa, off-label and experimental drugs are required should be avoided by the courts - revoked in the III Journey . Inclusion of the claimant in a service or program that already exists in the SUS when dealing with a drug, product or procedure already provided for in the official SUS lists or in PCDT - it was reworded in the III Journey . Medical prescriptions must register the treatment or drug, using the Common Brazilian Denomination (CBD) or the Common International Denomination (CID), its active ingredient, followed, when relevant, by the reference name of the substance, posology, mode of administration and period of time of the treatment and, in case of prescription different from that expressly informed by its manufacturer, the technical justification - II Journey approved 23 statements, eight of which involve medications, including: . Judicial measures for access to medications and materials not registered by Anvisa or for off-label use should not be granted, except with proof of scientific evidence and urgent need - it was reworded in the III Journey . Recommendation for the magistrate to inform the Municipal and State Health Councils when actions are taking place in the same District for access to medications, products or procedures already included in official lists . Recommendation to verify whether the National Commission for the Incorporation of Technologies in the SUS (CONITEC, Comissão Nacional de Incorporação de Tecnologias) has analyzed the drug, product or procedure under judicial process . Recommendation that the prescribing physician be notified in court when there is a prescription for a drug, product, orthosis, prostheses or procedures that are not included in official SUS lists or protocols, clarifying the pertinence and need for the prescription and signing a declaration of any conflict of interest - III Journey approved 35 new statements, reworded 29 statements and revoked 11 of the first two Journeys Among the new ones, 12 refer to medications, highlighting: . Treatment abandonment occurs when the drug and other products have not been picked up for more than 03 (three) consecutive months, with the respondent being entitled to suspend the respective acquisitions, and the Court must be notified of the abandonment	18
Nacional	I, II and III National Health Journey (or Right to Health Journeys)		2019	Current	. The judicial authority may determine the inclusion in the process of scientific evidence documents (technical note or opinion) available in e-NatJus (CNJ) or in databases of the Technical Support Centers in Health (NATS, Núcleos de Assessoramento Técnico em Saúde) of each state, provided that related to the same drug, therapy or product required by the party . In decisions that determine the supply of medication or services by more than one entity of the federation, it should be aimed, if possible, to individualize the acts that will be the responsibility of each entity . The magistrate may order the defendant to deposit in court amounts that allow the plaintiff to purchase drugs or products granted by court decision, until the process of purchasing drugs for regular supply is completed, under penalty of confiscation of funds . The issuing of a writ of mandamus regarding matters of public health will only be admitted when the drug, product, orthosis, prosthesis or procedure appears in the RENAME, RENASES or SUS protocol list
State	Legal Actions Monitoring Center (NAAJ)	SES/SC	2007	Extinct	Assignments: . Clarifying questions from citizens, magistrates and members of the Essential Functions to Justice about the procedures for the acquisition and delivery of medications . Analyze the standardization or not of the requested medications, indicating therapeutic alternatives or formulating technical opinions regarding those not standardized by SUS . Register the processes in its own system	4, 21
	Multidisciplinary Judicial Support Commission (COMAJ)	SES/SC	2011	Current	Assignments: . Coordinate, guide and monitor compliance with court orders in the health area . Receive and forward lawsuits and requests for administrative information about health care . Carry out actions related to the reimbursement of amounts spent in legal proceedings involving the Federal Government and/or Municipalities . Work together with SES/SC, PGE/SC, Judiciary and MPSC in preventive actions in the judicialization of health	22
	State Monitoring and Resolution Committee for Health Care Demands in Santa Catarina (COMESC)	Several	2012	Current	Approved 21 statements, 14 of which deal with medications, including: . Ordered actions with prescription and report of physician in practice in SUS . Medical prescriptions must contain medication by CBD or CID, active ingredient, dose, route of administration, time of treatment . Periodic presentation of medical prescriptions, every three months, or in a shorter period, in accordance with health legislation . Existence of registration Anvisa - Approved Recommendations, including: . Exhausting drug alternatives from standardized lists before opting for other drugs . Compliance with decisions regarding deadlines, confiscation of values and fines	27
	Legal Asset Management (GEJUD)	SES/SC	2013	Current	Activities: . Logistics for the storage and distribution of legalized medications and supplies	Study data
State	Operational Support Center for Human Rights and the Third Sector (CDH)	MPSC	2012	Current	Assignments: . Defense of human rights, with emphasis on the right to health, education, protection of the elderly and people with disabilities, the control of psychiatric hospitalizations, the inspection of institutional acts and the management of third sector entities and residual issues of civil law	28
	Technical Support Center for the Judiciary (NAT-JUS)	SES/SC	2015	Current	Assignments: . Advise magistrates: (a) with technical information on treatments recommended in the SUS and, in their absence, recommend a therapeutic alternative based on scientific evidence that justify or not the granting of the benefit; (b) in matters related to lawsuits seeking to provide health care, through the preparation of technical opinions . Propose the use of standardized medications in SUS, based on official lists and their respective updates, in addition to considerations issued in Opinions by Conitec . Suggest the search for the incorporation of new technologies together with Conitec	23
	Decree n. 241	SES/SC	2015	Current	Obligation of SC public servant prescribers: . Prescribe medication and request health tests and procedures in terms of public policies, from standardized lists and PCDT . Technically justify the prescription when there is a need for drugs not included in the lists	24
	Center for Repetitive Actions in Health Care (NARAS)	PGE/SC	2015	Current	Assignments: . Representing the Public Treasury in the repetitive actions in health care attributed to the Central-Headquarters Execution Organ . Promote the standardization of the defense theses . Propose legal and administrative measures to prevent litigation . Create theses related to health . Articulate the dialogue with organs and authorities of the Executive and Judiciary Powers	30
	Incident of Resolution of Repetitive Demands (IRDR)	TJ/SC	2016	Current	For the legal granting of standardized medication or treatment in the SUS, the following requirements are: . Need for the drug and adequacy to the existing disease, certified by a physician . Demonstration, in any way, of impossibility or impediment to obtain it through the administrative route For the judicial granting of a drug or procedure not standardized by SUS, the following requirements are: . Effective demonstration of financial insufficiency . Absence of public policy for the existing disease or its inefficiency, plus proof of the need for the drug sought by all means, including expert medical evaluation	31
	Ordinance n. 804	SES/SC	2017	Current	Responsibilities of the Health Managements (GERSA) in relation to lawsuits: . Monitoring, receiving, responding to inquiries, providing evidence of delivery and/or execution of services, carrying out exams, procedures, providing supplies and medications Responsibilities of the Health Manager: . Carry out actions and supervise the technical team to work with the municipalities within its scope and being responsible for complying with state judicial demands, considering the decentralization of SUS . Establish inventory control of lawsuit demands in the Management or in the municipalities covered by it . Proceed with the return of medications, supplies or materials to the central administration, within 10 (ten) days, when 02 (two) months have passed without moving these products under their custody	25

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E-mail: cienciasaudecoletiva@fiocruz.br

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[1] Collaborations

CR Caetano participated in the study design, data collection and analysis, drafting of the first version of the manuscript and final version review. FC Matheus worked on the review and final version of the manuscript. EE Diehl participated in the study design, data analysis and worked with the review and final version of the manuscript.