In the lawsuits studied, it was identified that most of the claimants for oncological medications were women, representing 54%. Similar studies have found this association between women and health services [62,63,64,65]. In addition, this statistic highlights cancer as a family disease and the role of women as formal and informal caregivers of individuals with cancer who could have filed these lawsuits on their behalf [64, 66,67,68,69].
The most frequent age groups were people over 55 (52%), with those over 65 representing 30% of the total. In addition, adult and elderly women appear as claimants in other studies [65, 69, 70].
The average income of the plaintiffs in the lawsuits was 1–3 × the minimum wage. Considering that the cost of treating an individual with cancer can exceed R$300.00 per month, the impact of treatment on the family’s finances is high, resulting in suffering and stress [25, 71].
All actions were individual, with the same result found in other studies [44, 65, 72]. The preponderant procedural representative was the Public Prosecutor with 47.74% of the cases, followed by the Public Defender’s Office with 35.80%, and finally, private lawyers with 16.45% of cases. It is important to emphasize that in the requests made by the Public Prosecutor and the Public Defender, the rate of granting preliminary relief is high. Furthermore, preliminary orders have a definitive and irreversible character [73]. Therefore, it could be thought that judicialization is not a tool to promote equity in access to cancer drugs [74].
Regarding the judicial entity, the state of Goiás (88%) was preferred over the federal government (12%) in the present study. In addition, time may have been a determining factor in the choice since, as it turned out, the average time from filing to the delivery of judicial resolution in the state court (8.45 ± 0.87 days) was shorter than in the federal court. (43.5 ± 12.90 days), which could explain the choice. Health-related claims are based on pressing health needs; injunctive relief must be granted to improve life, demonstrating a conceptual mismatch between procedural urgency and medical urgency/emergency [75].
Colombia is also judicializing access to health care through its supreme court, and there has been a growing use of injunctions to protect social rights such as health care indirectly. For example, the judiciary can protect a social right if its non-enforcement causes a violation of a fundamental right, such as life, physical integrity, or human dignity. This understanding is called the doctrine of connection [76] and underpins judicial decisions on the subject in Brazil.
The joint liability of federative entities expands access to judicial intervention. However, the federal government will always be in better financial shape to protect the fundamental right to health concerning the supply of high-cost medicines than states and municipalities [77].
Protecting social rights involves different interpretations according to ideological convictions and the interpreter’s point of view. The judicialization of health, in this context, must be analyzed as a consequence of a hermetic phenomenon involving the need for inter-institutional dialogue and integrated action, whether concerning the current international intellectual property system or policy discussions on research, development, and innovation, whether in price regulation in the pharmaceutical market or assessing which health technologies to include on official lists [78].
The judicialization of health challenges judges to mediate a non-legal conflict between politics and services, impacting public health policies. At the Public Defender’s Office, the challenge is smaller, as this office has practically specialized in demands for comprehensive health care since its implementation in the state in 2016. Before that, through the Chamber of Deputies Technical Assessment in Health (CATS) 2009, the state Public Prosecutor analyzed medication demands with a team composed of health professionals [48, 79,80,81]. These organizations’ specialized case sponsors and free service could explain the greater appearance of public organization sponsors in the study (public defender and public prosecutor) to the detriment of sponsorship by private lawyers and the high number of preliminary orders confirmed in decisions [63, 69].
A medical report must be presented to request medicines in court [43, 48]. In most processes (97.88%), the medical report originated in the public system. In some studies, most reports originated in the private system (38%) [69]. In addition, the medical report or prescription of public origin, issued by a professional from SUS, has greater weight as the primary evidence that the health system recognizes the need [73, 82]. Medical reports of public origin combined with the income of the participants demonstrate that judicialization is yet another way for individuals with low family income to access needed medications [6].
One notable aspect of the judicialization of access to medicines is the ability of the magistrate to request an opinion from the Center of Technical Support of the Judiciary (NATJUS) before deciding. NATJUS aims to provide technical support for decision-making based on scientific evidence in health-related actions. In addition, the Judicial Centers for Conflict Resolution and Citizenship (CEJUSC) act to self-composite available rights to resolve conflicts consensually within the state courts of justice [54, 55]. Although not binding, in its use, it can serve as technical support to support judicial decisions [48].
In Goiás, NATJUS started its activities in 2012, evaluating public and private health demands, verifying clinical protocols and therapeutic guidelines within the scope of SUS, and guidelines for use established by the National Agency for Supplementary Health (ANS) [83]. However, despite the recommendations, only 24% of the processes analyzed in the study used the opinion of NATJUS and CEJUSC.
In cooperation with the Ministry of Health, the National Council of Justice has created a National Opinion Bank, the digital platform (E-NATJUS System) for NATJUS opinions throughout the country. The system is available for consultation by magistrates. The objectives of the platform include reducing the possibility of conflicting judicial decisions on issues related to medicines and treatments and the concentration in a single database to avoid the formalization of requests whose treatments are not recommended by official health agencies [41, 84]. In Goiás, in 2020, there were 2016 consultations and 2081 opinions formulated, originating from requests from 1st-degree magistrates, mostly [83].
The most prevalent neoplasm in the lawsuits was brain cancer, followed by multiple myeloma. In the study by CERVI et al. [44], in 2020, in the state of Rio Grande do Sul and by Santos (2021) [65] in São Paulo, the most frequent neoplasm was also multiple myeloma.
Of the most requested drugs in the study, bevacizumab is indicated for metastatic colorectal cancer, advanced or metastatic lung, metastatic breast, renal, ovarian, and metastatic cervical cancer. In addition, bevacizumab was considered the agent of choice in clinical protocols and therapeutic guidelines for managing diabetic retinopathy, glaucoma, and neovascular age-related macular degeneration (AMD) in 2018. However, after the non-renewal of off-label use by the resolution of the collegiate board of ANVISA, CONITEC in 2021 recommended other drugs for this purpose (aflibercept and ranibizumab) [55, 85].
The addition of bevacizumab as a molecular therapy to palliative chemotherapy in patients with recurrent, persistent, or metastatic cancer was associated with a 3.7-month improvement in overall survival. Even so, this improvement would not be considered cost-effective in the United States, given the price of the current treatment [86]. Indeed, in the study by GOMES et al. (2021) [25], the total average cost of treatment was R$531.87, estimated per procedure session.
In the present study, in most of the legal requests for bevacizumab, it was prescribed for AMD when it was legal for off-label use [69, 87].
The drug temozolomide was, together with bevacizumab, the most requested. However, CONITEC, in a 2014 recommendation report on temozolomide for the adjuvant treatment of patients with High-Grade Gliomas, stated that using the temozolomide as an adjuvant in the treatment of brain neoplasia increased survival but decreased quality of life. Thus, the basis for improving the quality of life for access to high-cost oncological drugs is a paradox that deserves reflection since the administration of drugs in individuals with cancer can often worsen the desired quality of life in patients with cancer due adverse drug reactions [88].
Concerning the reasons for the judicial processes, 47% identified quality of life as the justification for requesting cancer medication. There are several concepts of quality of life. The World Health Organization (WHO) suggests this complex concept as a subjective way for individuals to perceive their lives, defining their goals and perspectives, including their satisfaction with life, cultural context, social, environmental, and value systems in which they are inserted [89, 90]. Notably, in 1995, the Food and Drug Administration (FDA) included the need to assess the quality of life for the approval of oncological drugs [91].
Considering that medical and pharmaceutical practice shows that oncological drugs cause many adverse reactions, are difficult to adapt to, and in most cases reduce the quality of life of patients, there seems to be a terminological confusion between improvement in quality of life and increased survival [92].
In order to be considered beneficial, an increase in survival must be accompanied by improved quality of life. Otherwise, it would prolong suffering and pain for the individual and their family. Indeed, prolonging life must respect the interests and dignity of the individual in question as an active participant in their care process, overcoming professional interests of trying to extend life at any cost with experimental treatments, prolonged hospital stays, and invasive procedures that increase the suffering they already experienced, in addition to being resource-intensive [93,94,95].
The judiciary cannot avoid the debate about resource allocation in health and its relationship with the principles of universality, equity, and integrality that guide SUS. However, it must also weigh this social protagonism with individual decisions that significantly impact the entire State structure [77]. For granting access to medications and other health technologies through judicial protection, the cost-utility analysis (CUA) should be suggested as an alternative. The CUA is more suitable for health-related quality of life, focusing mainly on the quality of the health outcome produced or avoided and introducing the QALY concept – quality-adjusted life years [96]. QALY is a cost-to-effectiveness threshold calculation that aims to maximize years and quality of life from a utilitarian perspective.
CONITEC suggests that the economic evaluation and cost-effectiveness parameters for approving new technologies for SUS should be based on quality-adjusted life years (QALY). However, a cost-effectiveness threshold and the QALY cannot be obstacles that hinder other relevant decision-making criteria when it comes to adding new technologies to SUS approval lists [97].
Indeed, the experience of countries like Australia (Medical Service Advisory Committee—MSAC), Canada (Canadian Agency for Drugs and Technology in Health—CADTH), and the United Kingdom (National Institute for Health and Clinical Excellence—NICE) in health technology assessment may represent an important starting point for CONITEC in the adoption of cost-effectiveness thresholds. However, it should be noted that these value definitions are context-specific, depending on local wealth, health system characteristics, availability, ability to pay, and social preferences. Therefore, such issues must be considered while issuing the regulations in art. 19-Q, §3, of Law No. 8.080/90 [98].
Indeed, health benefits can be maximized, including cancer drugs, through cost-effectiveness (or utility) weightings based on quality of life, achieving the ideals of justice without abdicating the primary public interest [73].