text in 
English (pdf)
Article in xml format
Article references
Automatic translation
Permalink
INTRODUCTION
In some situations, users of the Unified Health System (SUS) need to access health technologies to regain their health status after they become ill.
Among the collection of technologies used in healthcare, which is constantly expanding, are medicines that, due to such growth in supply and demand, present difficulties for public health authorities in making them available to users of the system. Such difficulty leads to patients not being served, in violation of the right to health established in the Constitution.
This difficulty is sustained by the increase in costs related to both physical infrastructure and human resource training, as well as the updating of regulatory and certification instruments1.
In this context, the judicialization of health, which involves seeking health treatments through the intervention of the Judiciary, is a phenomenon that reflects the points of tension and conflict that affect the right to health, and is a phenomenon that is increasingly evolving2.
The right to health in Brazil is materialized, as a public service, through the Unified Health System-SUS, as a quality of the institutional response to social demands and struggles, established by Law Nº. 8,080/1990 and 8,142/1990, regulated by Decree Law Nº. 7,508/2011, based on the Federal Constitution and accommodates the health actions and services to be practiced by the governmental triad, guided by the principles of universal access, comprehensive care and equity of care, with the State being responsible for providing the indispensable conditions for its full exercise3,4,5.
However, when a sick citizen seeks out government entities for health care and is denied such care, they resort to the Judiciary, transforming the demand for health into the judicialization of health which, in the view of Pereira (2015)6, is a growing provocation by the Judiciary to resolve situations that are assumed to affect the other Branches.
Thus, given the impasse between the citizen in need of medication and the health entities that are unable to provide them with care, it is understood that it is possible to construct responsive proposals and projects that transcend legal passivity, since the guarantee of rights in the legislative texts is not sufficient to make them truly effective7.
In this context, the general objective is to analyze the access of SUS users to medication, through the intervention of the Judiciary.
To this end, we sought to describe the path taken by SUS users to access the medication, identify the (mis) alignment between the prescription and the provision of the medication in the public network, identify the user’s perception regarding the right to health and describe the factors responsible for the judicialization of the medication.
METHODS
Type of study
This is a descriptive study with a qualitative approach, as it involves the application of the interpretation of social realities, considering the beliefs, cultural and power relations experienced in people’s daily lives8,9.
Place and period of study
The research was carried out from August to November 2017 in the municipality of Rio Branco, capital of the state of Acre, located on the banks of the Acre River, in Western Amazonia, northern region of Brazil.
Study participants
After consulting the Legal Department of the Acre State Health Department – SESACRE, one hundred and thirteen Unified Health System-SUS users who had filed a lawsuit over the medication were identified. Of these, ten appeared, including two mothers representing their minor children. The doctors and Judiciary employees invited were six and seven, respectively, but the ones who appeared were five and three, in the same order.
The participants were identified as follows: users identified by US 1, 2, 3...10; prescribing physicians by MP 1,2,3,4,5, and Judiciary employees by JU 1,2,3, totaling eighteen participants.
Data collection
Data collection was carried out using the focus group technique, with two separate groups being created, with nine participants each.
Initial organization of data collection: focus groups
The focus group aims to assess the human capacity to form opinions and attitudes when interacting with others, and is carried out through conversation and/or interviews directed at small homogeneous groups, to the point of extracting information, whether consensual or not9.
Focus groups were held on November 22 and 23, 2017. This technique was created in the 20th century by sociologist Robert K. Merton, because, in addition to accommodating the interest in understanding attitudes, preferences, needs and feelings, it allows for a qualitative evaluation of the information externalized by participants10.
Furthermore, in accordance with the literature regarding a small number of participants (six to twelve), in a calm environment, with discussions guided by a script with questions that lead to enthusiastic debate, without distraction or lack of interest in the opinion of others11,12,13.
Thus, in addition to the researcher, two collaborators and two professionals responsible for the recording, 18 research participants attended the focus groups, distributed into nine in the first group and nine in the second. The two meetings took place on consecutive days, November 22 and 23, 2017, with each focus group called GF I and GFII, corresponding to the first and second day, respectively. Each meeting lasted two hours, starting at 3:00 p.m. and ending at 5:00 p.m., and the focus groups were formed, distributed and characterized, according to the details explained as scheduled (figure 1).
Data organization and analysis
The data obtained were analyzed in terms of the content adopted in the speeches, based on the systematization of the diverse contents present in the messages expressing the experienced reality, according to Bardin14.
The meanings of the speeches were then observed and the data obtained were organized into stages I, II and III - Pre- analysis, Exploration of the material and Treatment of the results, as shown in figure 2, which allowed the construction of the Corpus of the study with its stages, definition of criteria and categories.
Stage I: content analysis/ pre-analysis
Stage in which the transcription of recordings and the preparation of reports took place with exhaustive and repeated readings with the intention of identifying the saturation of ideas, construction of the Corpus, definition of hypotheses and objectives, and the interpretation of the observed perceptions.
For Bardin (2010, page 96)15, the Corpus of the study: “ is the set of documents taken into account to be submitted to analytical procedures”.
The construction of the Corpus was based on the separation of the material from the discussions, which led to the construction of the entire analysis, along the lines of Bardin (2010)15, which resulted in 4 thematic axes: I-ACCESS to medication; II- (DIS)ALIGNMENT between prescription and provision of medication; III- RIGHT TO HEALTH; and, IV- JUDICIALIZATION.
Considering the Corpus, the objectives, pre-categories and rules to be implemented in the next phase were defined. The objectives were to describe the path of the Unified Health System-SUS user to access the medication; identify the (dis) alignment between the prescription and the provision of the medication in the state public network; analyze the perception of the SUS user regarding the right to health; and describe the factors responsible for the judicialization of the medication.
Finally, the establishment of rules, starting with the selection of colors to identify the registration units by category, the absolute frequency (AF) represented by the number of times there is repetition of citations, words or themes, the weighted frequency (FP), considered as a percentage, as the greatest attribute given to each word, theme or meaning, and direction (D) – moving on a scale from +3 to -3, with 3 being the greatest amount of possible systematizations within the defined categories.
This step is best presented in figure 3 below, (figure 3).
Stage II – content analysis/material exploration
We continue with the second stage - Content analysis / Exploration of the research material. We thus enter phase II - exploration of the material, guided by the rules mentioned above, expressed in a flowchart shown in figure 4.
Source: adapted from SILVA et al. (2018)16.
Figure 4 Exploration of research material. Phase II. Rio Branco, Acre, Brazil, 2020
At this stage, starting from the study Corpus and the pre-analysis categories, the identification of the registration and context units begins.
It is important to note that the Registration Unit -UR corresponds to fractions of content, such as a word, theme or phrase, which will be used as a reference when categorizing and counting frequency. Regarding the Context Unit, it is understood as the unit of understanding to encode the UR and corresponds to parts of the message so that the meaning of this UR can be understood17.
Correspondence between color/cutout of registration units
Continuing to explore the material, commands were used to encode the Registration Units (RU) and Context Units (CU), aligned with the Bardin spectrum, adopting the colors: purple for Category I, pink for Category II, green for Category III and blue for Category IV. Furthermore, to finalize this stage, the enumeration rules were defined.
As established by Bardin (2011)14, to better define the UR and UC, a count is adopted following criteria, the following being those stipulated in this study.
Rules for enumeration/evaluation of registration units
According to what was established in the first phase of the analysis, after reading and separating the registration units, there are enumeration rules for organizing these units and subsequently constructing the context units.
In this way, according to table 1, the rules and definitions of the parameters have been systematized, from Bardin’s perspective, for their execution.
Table 1 Systematization of the enumeration rules and criteria adopted in the research, from Bardin’s
| Categories | Absolute Frequency and Weighted Frequency | Content Weight-Direction |
|---|---|---|
| Path and Access to Medication |
The occurrence of absolute frequency followed the number of times that content was cited that referred to access to the medication, with or without scientific proof. The weighted frequency considered the highest weight to standardized medicines within the scope of the SUS, in accordance with the current national policy. |
The attributes adopted in the analysis of the direction, based on the weights defined for the contents, go through the weight (-3) for the approach of factors/ circumstances relevant to access to the medicine outside the expected path, in disagreement with the current health policy, reaching the weight (+3), for medicines with availability and in accordance with their access as inserted in the current health policy. |
| (Mis)alignment between prescription and provision of medicines |
In absolute frequency, the number of times that terms appeared that were pertinent to the (mis) alignment between prescription and availability in the public service was considered. In the weighted frequency, prescriptions originating from the SUS were considered to have the greatest attribute. |
The attributes adopted in the management analysis vary between weight (-2) for linking access to medication to certificates/reports up to weight (+3) for prescriptions within the protocols, for diseases within the protocols, and availability of medications. |
| Perception of the right to health | To analyze the rules of absolute frequencies, the number of times that terms related to the right to health, laws, public health care, public and private justice and mention of taxes appeared was observed. For the weighted frequency, it was decided to apply the highest attribute to references to legislation. | The analyzed steering criterion assumes a variability of weights between (-1) for signs brought from common sense that link the right to medicine to the payment of taxes up to (+3) for those circumscribed to the legal universe. |
| Factors responsible for judicialization | The analysis of the absolute frequency rules considered the number of times in which statements in favor of judicialization appeared. The weighted frequency encompasses the highest weights for the health-disease process and user needs. | The management criterion analyzed did not include negative values, since all mentions are relevant to factors that encourage judicialization, so that the maximum value (+3) was related to the disease, the precision/need to restore health. |
Source: Prepared by the authors.
After establishing the rules, the Absolute and Weighted Frequencies and the assignment of Weights to the contents (PC), this section is closed with the construction of the Context Units (CU) and the organization of the evidence.
Stage III – content analysis/results processing
From the conformation of the context units dealing with the theme of the judicialization of medicine under the various points verbalized by the users participating in the study, the theme is understood in its most varied aspects so that dialogue between the ideas mentioned and the state of the art pertinent to the object of the research is possible, in order to then interpret and extract what may be new for science.
Ethical aspects
All subjects previously gave their consent by signing the Free and Informed Consent Form (FICF). The study was conducted with the approval of the Research Ethics Committee of the Faculty of Juazeiro do Norte (FJN), under the CAAE protocol: 6551.7517.4.0000.5624, Consolidated Opinion Nº. 1,975,403, of March 21, 2017, observing the dictates of Research Ethics established in the Resolutions of the National Health Council of Brazil (CNS) Nº. 466/2012 and Nº. 510/2016.
Study limitations
The lack of consolidated data on lawsuits for medicines in the Court of Justice of the State of Acre, the lack of telephone contact between users claiming the drug within the scope of the Secretary of State for Health-SESACRE and the scheduling conflict of doctors and employees of the Judiciary Branch were limitations to the research.
RESULTS
In this study, conducted using the model proposed by Bardin (2011)14, four categories were constructed based on the evidence identified. The rules of frequency and absolute and weighted frequency were applied, which refers to the counting of repeated words throughout the statements, highlighting the importance of the position of these units (words), and then the rule of direction.
Category I - SUS user’s path and access to medication
This category involves the path that the Unified Health System-SUS user takes in the search for and access to medication, noting that both the municipal and state health units were visited, as well as the judiciary, with many of the statements being characterized by coming and going, as can be identified from the verbalized manifestations.
“.... I went to semsa ... to sesacre – the state... Then I went to the public ministry... and... to three different pharmacies .” US6
“...I went directly to small claims court .” US7
“…I went to the public prosecutor’s office in the state of Acre. … to the secretary’s office (I have a friend there).”US1
“I went to get the medicine at the health center where the doctor consulted.” US2
“In the case of health, it is common... the medicine is on the list and the government cannot meet the demand. There is a shortage of medicine !” JU2
“treatment with that medicine on the list has already been carried out... there was no result, while this prescribed medicine will be more efficient .”JU 1
In the category in question, words or ideas were identified in a total of 113 (one hundred and thirteen) repetitions as expressed by the research participants, systematized in 13 (thirteen) speech contents/URs, which were quantified and ordered according to absolute frequencies and weighted frequencies.
It can be seen that the URs “I went/Went to public/ private bodies”, “Public Service”, and “Secretariat/ Secretary/Secretary of State for Health-SESACRE/ Health/Municipal Health Department- SEMSA”, obtained the highest number of repetitions (14 times each), while “Court” was the least cited (2 times). It can also be seen that “Public Defender” and “Foundation/hospital” are tied in 4th place, with 11 citations each, with each of them accounting for 9.7% of the weighted frequency.
Regarding the other weighted frequencies (%), the URs “I went to/went to public/private bodies”, “Public Service”, and “Secretariat/Secretary/Health/SESACRE/ SEMSA” are the most frequent, each accounting for 11.5%, sharing the 1st position. As for the registration unit with the lowest frequency, “Court” is the one with 1.8%, occupying the 9th position.
Category II – (Mis)alignment between prescription and provision of medication
This category includes passages that refer to medicine, which was often referred to as medicine, medication, therapy, treatment, and those that involve prescriptions/receipts and standardized lists in the SUS. The fact that the medicine is not available or is missing, including the mention of the SUS lists - National List of Essential Medicines-RENAME/ Municipal Medicines List-REMUME, is evident in the statements.
“... I don’t tell the doctor - prescribe what’s in the SUS; I say prescribe what you think will make my son better.”US5
“After 8 months they released me, but by then I had already lost the graft. So I’m back in line...” US3
“In the case of health, it is common... the medicine is on the list and the government cannot meet the demand. There is a shortage of medicine !” JU2
The words or ideas that reflect Category II are consolidated in 16 (sixteen) speech contents/UR’s, totaling 227 (two hundred and twenty-seven) repetitions (absolute frequency). Considering the contents in question, according to the absolute frequencies, it is observed that “Medication” is the most mentioned, with 80 citations, occupying the 1st place , while “Therapy” and “Dispensing”, sharing the 13th place, with 01 citation each, occupy the last position.
It is pertinent to mention that the UR’s “Report/ Certificate” and “Passed/Passed/Prescribed” share the same 8th position; tied in 11th place are “Administrative protocols” and “Not included in the therapeutic guidelines”, as well as, in 13th place, “Therapy” and “Dispensing”.
Category III – Perception of Unified Health System-SUS users regarding the right to health
The category presented here systematizes the statements of the user participants regarding the perception of the right to health, registering among them SUS and medicine, as responsibilities of the State, with citation of the characteristic icons of justice - law, judge, lawyer and others, and also, the payment of taxes, according to the statements below:
“...you don’t have to be quiet... the constitution says it’s a right... We don’t have to give up... a right... we pay taxes!” US5
“...she has to go after it, insist on the public defender’s office. I insist, I’ll go there; I’ll run after it, I won’t give up. ” US 6
“... I’m in line again waiting for a kidney. I could have easily not lost it. Does that mean I’m trash? I told the judge! US3
“...The State does not have to offer it if it is not for that disease.”US5
The words/Registration Units - UR’s identified as characteristics of this category make up 11 (eleven) ideas of speech content/UR’s, totaling 211 (two hundred and eleven) repetitions (absolute frequency), and are shown in table 4.
The registration units (RU) discussed here, according to their respective absolute frequencies, are organized in such a way that “State” is in 1st place, with 68 (sixty-eight) mentions, and, at the other extreme, “Lawyer” with 2 (two) mentions. The registration units “Tax(es)” and “Process” are tied in 6th place, with 12 (twelve) repetitions each.
Category IV – Factors responsible for the judicialization of the drug
In this category, it was evident that the disease is the triggering element for judicialization, inadequate management of public resources, self-declaration by the user of lack of resources, need to use the medicine and the high prices charged by the market, as stated below:
“...I had to go to court to get the medicine that was missing from the health centers”US2
“On one hand, there is the right to health... This right is guaranteed in the constitution. But does it exist in the specific case of that citizen? It will depend on the real situation.” JU2
“...it is possible to request a medicine that is not on the list... as long as it is justified .” JU1
“…medicine that is planned, but is not available... generally it can be... inability of the public manager in managing resources.” JU3
The mentions regarding the factors that trigger judicialization, both by users and doctors and members of the judiciary in the study, are revealed in the speeches given and allowed the construction of the fourth and last category, characterized by 6 (six) registration units - UR’s that are repeated 49 (forty-nine) times (absolute frequency).
The UR “I need/I needed” was repeated 16 times, taking first place, while “Necessity/Needed” received 1 mention, taking last place. With the exception of the 1st and last UR, the remaining four share tied positions, as follows: “Disease” and “Money”, with 10 (ten) mentions each; and “Public Resource Management” and “Cost” with 6 (six) each.
Applicability of the Direction rule
Finally, the applicability of the direction rule (D), which guides the elaboration of context units (CU), which are consequent to the registration units and responsible for the greater significance of the expressions verbalized by the participants.
Thus, the most repeated expressions by category admit the metric +3, which is the greatest attribute defined in the research, and are listed by category.
For Category I – Path and Access for Unified Health System -SUS users to obtain medication, there are URs that are consistent with what is established in the current National Health Policy/SUS.
The URs under discussion refer to access/access location whose positioning occurs within the health care network, and are: “I went to public/private institutions”, “I managed to get/I got/I got the medicine”, “Public Service”, “Health Center/Unit”, “Foundation/Hospital” and “Access”.
In Category II – (Mis)alignment between prescription and provision of medication , the segments that express the alignment between prescription and provision of medication are considered to be of greatest relevance. The URs are: “Medication”, “List/- National List of Essential Medicines-RENAME/ Municipal Medicines List -REMUME”, “Medicine”, “Medication”, “Prescribed/Prescribed/Prescriber”, “Has/Had/Exists”, “Passed/Past/Prescribed”, “Available/Availability”, and “Therapy”.
Regarding Category III – SUS user perception regarding the right to health, these are the URs regarding the right to health and mention of the State, regardless of the sphere where health care was provided, namely: “Right”, “Health”, “SUS”, “Guarantee/Guaranteed/ Guarantee”, and “Constitution”.
Finally, in Category IV - Factors responsible for judicialization, there are the UR’s “Illness”, “Need/ Needed” and “I need/needed”.
After establishing the rules, counting the Absolute Frequency (AF), Weighted Frequency (FP) and assigning weights to the contents (PC), according to the prioritization of the Registration Units (UR) according to the importance of the words and direction, and the definition of the UR’s , the closing of this section occurs with the construction of the corresponding Context Units (UC) and the organization of the evidence, as shown in table 2.
Table 2 RRecording units, context units and thematic categories, from Bardin’s perspective. Rio Branco
| Category | Registration Units (RU) | Context Units (CU) | Thematic Category |
|---|---|---|---|
| 1 | I went to public/private institutions; Public Service; Health Unit; Foundation/Hospital; Secretariat-Secretary/ SESACRE/SEMSA; Public Power/Judiciary; Public Prosecutor's Office; Search/Search; Public Defender's Office; Court; I Got/Got/Got; Access | The path of users to the instances naturally linked to health care, as well as to the judicial ones. The natural health instances include the Public Service composed of health centers, Hospitals, Hospital Foundation, Health Departments – municipal (SEMSA) and state (SESACRE), up to the secretary's office. In fact, a path to private pharmacies was also evident. The judicial instances indicated accommodate the Judiciary and its bodies – Public Defender's Office, Court and Public Prosecutor's Office. | path and access to obtain medication |
| 2 | Medication; List/RENAME/ REMUME; Medicine; Lack/Did not have; Medication; Prescribed/ Prescribed/Prescriber; Has/Had/Exists; Report/ Certificate; Passed/ Passed/Prescribed; Available/Availability Prescription/Prescription; Administrative protocol; not available; available; Therapy Dispensing | The provision of medicine (medicine, therapy, medication, according to the synonyms used by users) is affected by several factors, whether aligned or not. Aligned, when the medicine (or synonyms used here) is included or appears in the RENAME/REMUME Lists, exists or is available in health units, is prescribed, prescribed or prescribed by the doctor in accordance with established health protocols. Misaligned, when the medicine is not available, does not exist, is linked to reports/certificates of insufficiency and administrative protocol, is not included or is not included in the standardized lists in the public sphere. | (Dis)alignment between Prescription and provision of medication |
| 3 | Law; Health; SUS; Judge Tax (s); Process; Guarantee/Guaranteed/ Guarantee; Constitution; Justice; Lawyer; State | Health is often referred to by users as a constitutionally guaranteed right, through the Unified Health System – SUS, and, sometimes, ensured through legal means, sometimes mentioning payment for the services of a private lawyer to file a lawsuit against the State. | Perception of SUS users regarding the right to health |
| 4 | Illness; Need/needed; Money; Public resource management; Cost; Needed/Need | Illness as the trigger for judicialization, inadequate management of public resources, user self-declaration of lack of resources, need to use the medication and the high prices charged by the market. | Factors Responsible for the Judicialization of Medication |
Source: Prepared by the authors.
Consolidation of analytical categories and evidence
The analytical categories of the study and the respective evidence that identifies them are demonstrated in table 3.
Table 3 Consolidation of the study’s analytical categories and evidence found, according to Bardin. Rio Branco, Acre, Brazil, 2020
| Study categories | Evidence pointed out |
|---|---|
| Path and Access to Medication | Walk through health institutions and judicial institutions – against the SUS. |
| (Dis)alignment between Prescription and Medication Availability | Non-existence/exclusion/of the medication in the standardized lists and dissonance between prescriptions and protocols. |
| Perception of the right to health | Constitution and payment of taxes |
| Factors responsible for judicialization | Disease, difficulty in access, lack of standardization and/or unavailability of the medicine, inadequate management of public resources, financial insufficiency and high market costs of the medicine. |
Source: Prepared by the authors.
It is evident that Unified Health System-SUS users experience a journey beyond health units/services, reaching the administration and judicial bodies in order to access the medication. When they experience the voluntary non-enforceability on the part of the State in granting the medication, the users emphatically mention the link between their right to tax collection by the State as a whole, and they blame such denial of access (of treatment) for triggering the decision-making for the judicialization of health. The SUS users sampled continue, referring to the need to recover health, being financially disadvantaged and the high costs of the medication needed as responsible for the judicialization of health, in the context investigated.
DISCUSSION
It is understood that the SUS users in this study, in order to have access to the medicines, went through both the Health Care Network, where the expectation is that the medicines will be found, and the Judiciary, an alternative route.
Access to medicine is established as a constitutional guarantee, through the SUS, which includes the National Medicines Policy (PNM), as reinforced by Article 6, item I, paragraph d, of Law Nº. 8,080/1990, when establishing the inclusion of comprehensive therapeutic care, including pharmaceutical care, in the list of actions of the health system. Access to medicines by people is essential in order to ensure universal health care with equity, accompanied by resolvability and quality18.
Thus, in relation to the route and access to the medication, users initially adopted the natural route, seeking out health units/services, including primary care health centers and posts, secondary care hospitals - Acre Mental Health Hospital - HOSMAC, tertiary care hospitals - Acre State Hospital Foundation - FUNDHACRE, and commercial pharmacies for budgeting. Around 90% obtained a favorable court decision, although the materiality of the delivery of the medication was not completed, neither in a timely manner nor in its entirety.
It is worth mentioning that two of the decisions concerned the delivery of financial resources to the user of this study for the purposes of purchasing the medication. For one of the claimants, only a portion of the money had been honored by State Department of Health of Acre -SESACRE, leaving the state in default at the time of the study.
It should be noted that 20% of users went directly to court to access the medication, considering the prior information given by the doctor that the prescribed medication was not part of the SUS protocols.
However, as illustrated by the statements configured by the context unit related to this theme, it is clear that the users’ journey in search of access to medication was marked by comings and goings, both to the instances naturally linked to health care and to the judicial ones.
However, health institutions had to be left behind, given the impossibility of making the requested item available, so another avenue explored was that of friends. They were sought out within the state and municipal health departments, and in the secretaries’ offices, as possibilities of finding the medicine.
Although not so conventional, but still within the health axis, this visit by users to the secretariats in the aforementioned circumstances, when unsuccessful, took them to the door of the local judiciary – public prosecutor’s office, public defender’s office and small claims court.
This coming and going in search of medication, which paves the way for the reality experienced by the study participants, runs counter to the Unified Health System-SUS, since the legal access proposed in Brazil’s health policy is based on principles and guidelines, highlighting the citizenship status of users.
The healthcare gap resulting from the inaccessibility of medication conflicts with the doctrinal principles of comprehensive care and universal access, which frame the national health policy of the Brazilian State. This conflict is identified in this research, when the reality of lack of care and access is mentioned.
In this logic, a study carried out by Álvares et al. (2017)18 in which 8,803 users of Basic Health Units from the five regions that make up the Brazilian State were interviewed indicates that 45.3% of people declared full access to prescribed medicines within the scope of the SUS. Of this percentage, the southern region stands out with 48.1%, as well as, at the other extreme, the northern region with 37%, although the authors understand the high compromise in access to medicines and the low availability of those in the essential line.
Thus, the misalignment of the universality, equanimity and resolvability of healthcare for the population becomes evident, divergent from what is postulated by the SUS18.
Globally, only 10% of people actually consume medication, thus indicating considerable inequality in terms of access19.
In this context, there would be no demonstration of the connection between the judicialization of medicines in the SUS and the increase in social inequality in access to medicines, so that it would not be proven that the phenomenon of the judicialization of treatments in the SUS compromises the SUS budget, even though the National Pharmaceutical Assistance Policy would not be able to meet the demand presented20.
Thus, talking about access, when the path taken by users to justice ultimately prevails over the path taken through the health sector, reflects, in part, a contradiction. In part, because 30% of the ten medications subject to legal proceedings - Oxicarbazepine , Etanercept and Cinacalcet - were standardized in the 2017 National List of Essential Medicines RENAME21, the time of the action, they should certainly be within the population’s reach.
In this sense, regarding the (Dis)Alignment between Prescription and provision of medication, within the scope of the SUS, there is the National Therapeutic Formulary – FTN, a compilation of pharmacological information pertinent to the appropriate use of medications that, according to the World Health Organization – WHO, constitutes a political and public health decision in the direction of promoting the Rational Use of Medicines -URM.
For Bermudez et al. (2018)22 the FTN is a tool that helps prescribers make the best decision regarding medication choice, enabling the preparation of a good medical prescription.
For the present study, the situation concerning the 7 medicines that were not included in the official list of SUS medicines, a possible alternative involves the inclusion of the aforementioned technologies in the protocols, given that the permanent review of RENAME and its continuous updating are actions already foreseen by the PNM, every two years, so that its organization is compatible with the “most relevant and prevalent pathologies and health problems, respecting the regional differences of the country”23.
The standardization of medicines adopted by the SUS is systematized in the National List of Essential Medicines - RENAME, which serves as a reference for states, municipalities and the Federal District to prepare their local lists of medicines; in the case of the municipality there is the Municipal List of Medicines - REMUME, in order to ensure access to medicines in the treatment of the pathologies that most affect the population24.
Therefore, a systematic analysis of pharmacoepidemiology in conjunction with local pharmacoeconomics can be used by the State in the decision, in a timely manner, not only for the insertion, but also for the exclusion and/or replacement of medicines that align with the state’s morbidity and mortality profile, thus bringing about corrections that are affecting access to the prescribed medicine.
However, talking about access to medicines, when the path taken by research users extends to the Judiciary and predominates over the path through the health (administrative) sphere, reflects, in part, a contradiction. In part, because three of the ten medicines subject to legal proceedings in the sample of this study - Oxcarbazepine , Etanercept and Cinacalcet - were standardized in RENAME21 at the time of the action (2017), and therefore should be within the population’s reach.
Although all users in the study received prescriptions through the SUS, 70% of the prescribed medications were not included in the official medication lists, so that of the remaining 30%, 20% belonged to the standardized specialized component and 10% to the standardized basic component, but all were unavailable for administrative access (extrajudicial route).
The judicialization of non-standardized medications by the SUS (70%), for this reason, is expected to ensure due access to the necessary health treatment for the patient. Thus, the search for judicial protection of the treatment in view of the unavailability of 30% of standardized medications gives rise to the understanding that this is an avoidable lack of care, which penalizes the State twice, considering that when it is judicially summoned to provide medications from the RENAME list, both the financing by the federal government and the financial transfer from the State to the Municipality had already been made, and this time (the judicial one), a new transfer in court must be made to correct an avoidable lack of care.
However, even when prescribed within the standards, these 30% of medicines included in the official SUS dispensing lists that are unavailable to the population configure the possibility that this misalignment is linked to deficiencies in the planning and logistics of public management, conferring losses on both users and the public administration, which will still suffer from the judicialization of health.
However, Dal Pizzot et al. (2010)25 point out that, in the center-south of Brazil, the SUS reaches many users with pharmaceutical assistance, providing essential medicines ranging from 53% to 93%, making an average service rate of 88.1%.
Likewise, Emmerick et al. (2009)26 identify, in a study carried out in five Brazilian states, a variation in the availability of prescription drugs of the order of 52.6% to 89.6%, with the highest percentage inherent in the availability of prescription drugs referring to the state of Espírito Santo, while the lowest percentage of prescriptions availability was in the state of Rio Grande do Sul, which establishes an average of 67.9%.
In agreement with this outcome, Naves and Silver (2005)27 when evaluating pharmaceutical assistance in primary care in the Federal District/Brazil, concluded that 61.2% of prescribed medications were properly dispensed to the community.
It is noted in the studies above and in this study, prescriptions outside the official lists, although the doctors in this research report predominantly prescribing medications in a manner aligned with RENAME/SUS. It is also noted that the doctors in this study point to the possibility of extra protocol and/or off -label prescription (which was not evidenced) when the pathology so requires and reinforce the necessary notoriety of proof of use by the scientific community, which should be based on comparative studies that point to advantages in terms of efficacy, safety or cost-effectiveness.
A study with 18 (eighteen) users in the municipality of Itajaí, SC, identified that no user was aware that they could seek out the State’s administrative bodies (Health Departments), before seeking assistance from a lawsuit to be filed before the Judiciary to enforce their right28.
Regarding the perception of the right to health in this study , users demonstrate that they are aware of seeking medication from health authorities, state/ municipal management and, at a later stage, before the Judiciary to guarantee access to their constitutional right to health.
There is a perception that the State does not voluntarily provide services, even with the payment of taxes, which users link to the constitutional right to health, but they realize that the tax relationship does not guarantee, in practice, the execution of the legal duty by the State, making it necessary, on certain occasions, for users to spend money on hiring the services of a private lawyer to take the health issue to court before the State.
However, the reference made by some users regarding the duty of the Brazilian State to ensure the right to health for all, in all their needs, unconditionally, is confronted by positions that have emerged considering the insufficiency of the State, current health policies and institutional aspects of organization and management.
Dallari et al. (2019)29 consider that before providing everything to everyone, the responsibly evaluation of the prescribed therapy, by considering the efficacy, safety, benefit of the treatment to the patient’s health, adequate scientific rigor and cost, to safeguard the Brazilian Unified Health System, as a national health policy.
It is important to highlight the discussion of judges in this study regarding the condition of benevolence on the part of the State in making the medicine available, with such “kindness” being promptly rejected by users, echoing the fact that such provision is a state obligation.
On the other hand, it was clear that users linked the right to prescribed medication to the payment of taxes. In this case, let us reflect: what happens to those people without resources, belonging to the poor, unemployed and those below the poverty line, if they cannot afford to pay “taxes” in addition to the built-in ones?
As in this study, mid-level Unified Health System –SUS’ professionals present the concept of the right to health linked to the payment of taxes30.
The discussion on the issue of taxes also involved the position of the State, so that participants in the justice system refer to the collection of taxes as the primary way, although there are others, of raising money to guarantee health services.
Sarlet and Saavedra (2017)31 bring to the discussion, within the scope of fundamental social rights, the problem of the State carrying out the provision of what is imposed on it by law, and which must maintain a link of dependence with the factual existence of the means necessary to give materiality to the obligation claimed.
However, linking the State’s obligation to provide health actions and services to its financial sufficiency is inconsistent with what is stated in the 1988 Constitution32, since in its Article 6 the right to health is established with a close link to the right to life and the principle of human dignity, such that the implementation of this right must be immediate and unconditional, considering that Article 196 of the Federal Constitution of Brazil-CFB/1988 establishes that health is a “right of all and a duty of the State”, and must be ensured through social and economic policies that aim to reduce the risk of disease and universal and equal access to actions and services for its promotion, protection and recovery. As it is a fundamental right, its guarantee must be implemented without discrimination, as a priority and without the need for additional conditions for its access.
The intrinsic link between the right to health and the foundation of the democratic rule of law, embodied in the principle of human dignity, makes the effectiveness of the right to health an imperative for achieving the State’s own goals, with dignity having to take precedence over other interests of the State, as it is a foundation of primary importance33.
From this perspective, the indication by some users regarding the duty of the Brazilian State to ensure the right to health for all, in all their health needs, is confronted by positions that have emerged considering the insufficiency of the State, the reality of current health policies, and other aspects of the organization and management of health and the State.
Dallari et al. (2019)29 consider that before providing everything to everyone, the responsibly evaluation of the prescribed therapy, by considering the efficacy, safety, benefit of the treatment to the patient’s health, adequate scientific rigor and cost, to safeguard the Brazilian Unified Health System.
On the other hand, the link made by users between the right to medication and the collection of taxes by the State is clear, which is in line with the study with mid-level professionals of the SUS whose conception of the right to health also links that duty of collection of taxes by the State28.
Tax collection was also highlighted by Judiciary officials as one of the ways for the State to raise money to guarantee health services, which are not the only concern of governments.
From the opposite perspective, linking the State’s duty to provide health actions and services to its financial sufficiency is not consistent with what is written in the 1988 constitution, when its article 6 states that the right to health is established with a close link to the right to life and the principle of human dignity, in such a way that the application of this right must be immediate and unconditional32.
Finally, regarding the factors responsible for the judicialization of the medicine, the participants bring to the discussion the difficulty of access, lack of standardization and/or unavailability of the medicine, personal/state insufficiency, possible disorganization of management (including inadequate management of public resources) and the high market value of the drug technology.
Based on the analysis carried out, it appears that the lack of medicines in health institutions and the self-declared lack of money/resources on the part of users are triggering elements for the judicialization of medicines, in addition to the need for technology, the high prices charged by the market and the lack of protocols and/or standardization.
Campos Neto et al. (2012)34 refer to a similar situation of lack of standardization, as well as the unavailability of standardized medicines due to shortages or logistical problems in pharmaceutical assistance, leading people to file lawsuits before the Judiciary.
In the study by Melo et al. (2018)30 the judicialization of health is reported as being due to factors linked, predominantly, to medications, alongside the demand for Intensive Care Unit-ICU beds.
In this vein, the judicialization of health can be understood as the intervention of the Judiciary in deciding on acts inherent to the health and/or administrative bodies of the State, with the aim of materializing the rights of citizens enshrined in the Constitution35.
More than a pun, the intervention and not the interference of the Judiciary is a thought that is based on paragraph XXXV of the Brazilian Constitution, since: “the law will not exclude from the assessment of the Judiciary any injury or threat to a right”32.
It is worth noting that Biehl, Socal and Amon (2016)36 reveal that most of the time (93.4%) the Judiciary is in favor of users demanding healthcare judicialization processes, determining that the state entity has the duty to respond to the request for medication immediately and fully.
Therefore, it is clear that the greater the lack of medication assistance in the SUS, the greater the queue that looms before the Judiciary Branch, reflecting an equally greater need for resources.
In this sense, the exponential growth of the judicialization of health is notorious, with the Union’s spending on the supply of judicialized medicines in 2007 being in the order of R$ 26,378,748.00 (twenty-six million, three hundred and seventy-eight thousand, seven hundred and forty-eight reais), jumping, in 2016, to R$ 1,325,707,898.00 (one billion, three hundred and twenty-five million, seven hundred and seven thousand, eight hundred and ninety-eight reais)37.
A broad theme such as the judicialization of health reflects the need to expand the subject, in order to contribute to the production of knowledge among the population and the scientific community38, as well as to guide public policies aimed at the need to maximize health practices that aim, above all, to meet the citizen’s right to health39.
Health practices by state agents in the health field must comply with bioethics based on human rights, as a measure of adapting actions to the minimum acceptable standard of quality in the provision of health services, which includes managers, health professionals and the formulation and implementation of public policies40.
The evidence found on judicialization in the Unified Health System -SUS in the literature points to a somewhat conflicting relationship between patient and State, since the latter has circumstantially denied the medication41.
Thus, SUS users experience a true “via crucis” in the search for medication, going beyond health institutions, reaching the administrative sphere, and, ultimately, the judicial sphere, demonstrating a clear perception of their right to health and the maintenance of human dignity, as well as the State’s duty to make the desired technology available.
However, statements regarding the receipt of medication/health care being linked to the payment of taxes are common in the statements of both SUS users and Judiciary employees interviewed, who also mention the inadequate management of public resources that is mixed with the other arguments already mentioned as factors in force in the exercise of the judicialization of health.
Most of the medications reported in this research, which were prescribed within the scope of the SUS, are not included in the SUS standards, which allows this study to contribute in a practical way to the decision-making and expressions of the health system, by pointing to the need for an accurate pharmaco-sanitary study of the population, enabling pharmaceutical assistance within the states of the federation to position itself synergistically with the real pharmacological need of the population.
It also helps federal states avoid wasting time and money spent on duplication, in the context of transferring resources to pharmaceutical assistance, enabling a better response to the user and the health system, favoring the effectiveness of the right to health and life for all.
CONCLUSION
In the process of accessing the necessary health treatments, SUS users occasionally seek the prescribed medication from state/municipal health management (healthcare networks) and, if this is denied, they resort to the Judiciary via the judicialization of health.
Both prescribed medications that were not in line with the Unified Health System (70%) and those that were aligned (30%) - included and not included in the Clinical Protocols and Therapeutic Guidelines-CPTG and in the medication lists, respectively, were subject to legal proceedings.
The financial vulnerability of users, the non-inclusion of medicines demanded in court in the Unified Health System-SUS medicine lists (National List of Essential Medicines RENAME, State List of Medicines-RESME and Municipal Medicines List -REMUME), the administrative denial of the medicine, and the high financial cost of medicines, were pointed out by users as determining factors for the judicialization of health.
The perception of SUS users regarding their fundamental right to the prescribed medication that they need under medical arguments is clear, and that the judicial system is the decision-making and resolving authority for their problem in accessing medication that is denied to them by the administrative bodies of the State.
