In Brazil, the integral right to health is an obligation of the State, written in the Federal Constitution, and it depends on the creation and implementation of public health policies. However, since the 1990s, Brazilian citizens have resorted to the judicial system in order to have access to medications and other health goods and services . This phenomenon is called health judicialization, and drugs are the most requested good [2,3,4]. The flaws in health policies and insufficient funds for the State to meet the growing demands in health care are the attributed causes of this phenomenon .
To guarantee the effectiveness of the right to health, the Brazilian justice system established the proceeding of state and non-state institutions. The former is organized into three branches: Judiciary, Executive and Legislative; and the latter is composed of the other institutions, one of which is the Public Prosecutor’s Office. The Public Prosecutor’s Office is an entity that is not within these powers. It has the role of inspecting and protecting the fundamental principles and interests of society and filing lawsuits when such interests are not at hand; it is essential to justice .
In healthcare, the Executive Branch is responsible for managing the Brazilian public health system – Sistema Único de Saúde (SUS) – which also guarantees access to essential medicines, guided by the National Medicines Policy  and by other laws and policies that define the medicines within the SUS formulary (belonging to the official lists of medications of SUS ). However, the SUS cannot meet the unlimited demands of Brazilians. When the State faces difficulties in offering health services and adequate universal well-being to all citizens, many people seek these rights through the Judiciary . The lawsuits are used by citizens to overcome the inaccessibility of medicines, caused either by the lack of financial resources to acquire them, by their unavailability in public health services or by the high cost of treatment, especially for the treatment of genetic diseases and neoplastic drugs outside the pharmaceutical care policy and represent an important part of the problem [5,10].
In the Brazilian democratic context, the health judicialization can express legitimate claims and ways of acting citizens. On the other hand, it bolsters an imbalance in rights by giving the privilege of obtaining these rights to groups of people who have the knowledge about the lawsuits and financial resources to appeal to the justice system .
Some studies show that users who use the Judiciary to request a medicine usually have better socioeconomic conditions because they can pay the procedural expenses generated by the judicialization. Thus, this phenomenon privileges certain social segments, favoring those who have greater access to the justice system and aggravates the inequities in access to health of a system already marked by inequalities .
The search for a guarantee of one´s right to health services and goods using the courts in the legal system is not a case isolated to Brazil and occurs in other countries such as Colombia, Costa Rica and Chile [13,14,15]. What stands out in the Brazilian case is the high rate of the lawsuits deferred by the judge, which has sparked discussions between professionals and managers of the health sector, as health judicialization not only can provide a useful mechanism for society to force the State to implement public policies but also can cause negative economic, social and political distortions .
In economic terms, judicialization creates costly unscheduled expenses for the Executive Branch and Judiciary. For the Executive, the spending in the federal sphere on such judicial demands has increased 1,000% (in the requested items) between 2008 and 2015, increasing from approximately US$32,928,388.75 to US$351,662,404.09, which has displaced the budget for other sectors of the Ministry of Health, such as the supply of drugs to primary care and the treatment of patients with STIs /AIDS; in addition, the Ministry of Health budgets showed a limited variation in this time period, which made planning and managing the public budget difficult . This is a distortion where some are benefiting while others are losing. It is a matter of only those who win in this process benefit while others may lose and/or have no recourse.
For the judiciary, it was observed that the spending on cases increased to approximately US$11,319,112,008 on lawsuits (administrative cost of appeals), which corresponded to 1.2% of the gross national product and was equivalent of handling an overall procedural burden of approximately 86.6 million cases . In 2011, there were 240,980 lawsuits in the health area, and they were primarily for requests of medications .
With regard to social distortions, studies have revealed that lawsuits can deepen the inequity of access to care in a health system already characterized by socioeconomic inequality. When individuals with better socioeconomic conditions, who are not participants of the SUS and are financially able to afford the lawsuits, are therefore favored. By favoring a few individuals, lawsuits interfere negatively with the principles of the SUS (universality and equity) because these demands shift the resources that should serve the majority (especially those who need it the most) in order to serve a few with smaller necessities [3,5,19].
The political distortions, lawsuits can interfere and cause distortions in the national medicines policy and force the government to provide medicines outside the SUS formulary, with little evidence of their efficacy and safety and which have higher costs.
This event may occur due to the members of the judiciary and the Public Prosecutor’s Office lacking the technical knowledge to interpret these policies. In lawsuits, there is no trial with competing experts and the judge decides based solely on the information provided in the plaintiff's request. In this case, the Government has not given an opportunity to answer the plaintiff's demand. The government has to comply with the judicial decision within the deadline stipulated by the judge. Such distortions can compromise the rational use of medicines .
Therefore, health judicialization has created tensions and motivated discussions about its legitimacy and the technical and/or legal and institutional competence of the judiciary system to decide about the content and the implementation issues of the state provision as implemented by the Executive Branch. In addition, it has caused an increasing number of individual demands for medications that increase public spending [2,3].
To rationalize these distortions, Brazil and other Latin American and Caribbean countries such as Chile, Costa Rica, Mexico, Peru, Uruguay and Argentina have proposed strategies, such as the creation of spaces for discussion between the actors in the health and judicial systems that help in the decision-making process according to the necessities of the population. For that, technical and scientific consultation committees were created to aid operatives of the law before filing a health-related lawsuit. Such strategies have helped in rationalizing the finite health resources, creating interinstitutional dialog between the actors of the Executive Branch and Judiciary and reducing new judicial demands, but initially, this is an increase in the bureaucratic system [21,22,23].
In Brazil, the creation of the Department of Assessment of Non-Standardized Medicines (Departamento de Avaliação de Medicamentos Não Padronizados - DAMNP) and the Technical Chamber of Health Assessment (Câmara de Avaliação Técnica em Saúde - CATS) were strategies deployed by a Brazilian state. The DAMNP was a department created by the Executive Branch in 2006 to exclusively analyze the technical and scientific rationality of medicines solicited by the users of the public health system by using an administrative case that has a prescription and a medical report. The technical analysis is performed by the pharmacists who evaluate the demands according to the norms of policies and the national legislation in force. When the solicited medicine outside the SUS formulary, the pharmacists suggest its replacement by one that belongs to the official lists of SUS. This strategy is responsible for establishing access protocols to medications in the Executive Branch and, when necessary, for the inclusion or exclusion of medicines on the official lists of the SUS medicines .
The CATS was created in 2009 by the Public Prosecutor’s Office of the same Brazilian state in order to offer technical support to public prosecutors about medicines solicited by the users of the public and private health systems . The opinions are from medical experts and pharmacists who analyze the content of the medical prescriptions and the report based on medical and scientific criteria and on pharmaceutical policies in force. Beyond that, these professionals, when possible, can train the providers to prescribe therapeutic alternatives made available by the SUS. It has contributed to perfecting access protocols for medicines in the Executive Branch, suggesting medicines to be incorporated into the policies and cut down on legal costs and bring evidence and expertise to the issue rather than just having lawyers try to sort this out .
The purview of the CATS was reaffirmed in 2010 when a technical cooperation agreement was signed between the Executive Branch and the Public Prosecutor’s Office. This agreement decreed that all demands for medicines not available under the official SUS lists would be resolved through the creation of an administrative case in the Executive Branch; institutionalizing the administrative case was viewed as a way to reduce the number of lawsuits .
It was noted that these strategies were adopted by jurists and health managers in many Brazilian states and conveyed respect for constitutional principles, such as the right to health as an aspect of human dignity and an access to justice [27,28,29]. However, little is known about the effects of these strategies regarding the negative repercussions caused by the judicialization of the health system. This gap in knowledge motivates the question: Do institutional strategies reduce social, economic and political distortions that the judicialization of medicine access brings to public administration?
In this context, the objective of this study was to evaluate the effects of two institutional strategies adopted by a Brazilian municipality in order to face economic, social and political distortions that involved the judicialization of access to medicine phenomenon.