Background
With the prominence given to the achievement of Universal Health Coverage (UHC) in the Sustainable Development Goals framework, the right to health and its legal enforcement are increasingly relevant [
1]. As stated by the World Health Organization (WHO) UHC is defined as “all people receiving quality health services that meet their needs without being exposed to financial hardship in paying for the services” [
2]. Thus, UHC is inclusive of effective coverage, i.e., access to quality health services (as opposed to insurance coverage) and protection against financial risk. UHC has been called a “practical expression of the right to health” [
3]. As countries progress towards UHC, policy-makers face difficult choices related to which services to expand first and to whom. Litigation over rights to goods and services will certainly play a role in how UHC is implemented, particularly in countries where the right to health is encoded in the national laws [
1].
The right to health as set forth in the WHO Constitution [
4] is defined as “the highest attainable standard of health”. Braveman and Gruskin [
5] argue that the highest attainable standard of health can be understood to reflect the standard of health enjoyed by socially advantaged groups within a society, since these could be possible for everyone living in that society. This means that equity in health helps to operationalize the concept of the right to health. WHO defines health equity as “the absence of avoidable, unfair, or remediable differences among groups of people, whether those groups are defined socially, economically, demographically or geographically or by other means of stratification” [
6].
In the case of Brazil, health is recognized as a fundamental right in Brazil’s 1988 constitution and the universal right to health is a founding principle of the Unified Health System (Sistema Único de Saúde [SUS]). Guided by the constitutional principles of universality, comprehensiveness/continuity of care and equality of access to health care, guaranteeing the right to health is a shared responsibility of Brazil’s three governmental spheres (federal, state and municipal) [
7].
On the one hand, the constitutional right to health can have positive effect on equity in access to healthcare if individuals who are denied access to specific medicines or technologies (due to e.g. health system delivery shortfalls or delays in inclusion of medications into SUS) turn to the courts to gain access and thereby uphold the principles of universality encoded in SUS. On the other hand, judicialization may increase inequity, if litigation leads to the careless use of medicines or services, or if individuals with better socio-economic standing who may last longer in litigation get priority access to medicines and health services at the expense of poorer populations. In such instances, litigation may violate the principles of SUS [
7] and ultimately the power to make public policy is moved from policy-makers to the courts [
8].
The inception of SUS led to profound changes in the healthcare system in Brazil with significant achievements, including the rapid expansion of primary care, the integration of several independent systems of financing and service provision into a single publicly funded system, and increases in government spending on health (with particular focus on basic care) [
9]. As a result, large improvements in health service coverage and health outcomes have been observed [
10,
11]. However, disparities in access to healthcare and health outcomes persist, with a higher level of utilization among high-income groups and unmet healthcare needs in populations living in poorer northern regions [
9]. Largely, health inequalities mirror income inequalities in the country [
12].
1
To operationalize the right to health in SUS, the government increased the health facility network and maintained the legal provision that anyone should have access to an open-ended benefit package free-of-charge under the SUS [
9]. Effectively, this implies that the government supply any medication judicially ruled, even if that conflicts with established public policy such as clinical protocols and therapeutic guidelines [
13]. The Judiciary has even made recent calls to have clear and objective parameters regarding which medications are covered by SUS [ibid].
In the absence of clear standards, consensus or criteria for which services and technologies should be financed within SUS, the courts have become important in adjudicating coverage decisions. Right-to-health litigation has increased exponentially. While data at the national level is not available, data from 7 out of 26 states showed that federal spending on court-ordered health services increased 40 times since 2005, reaching an estimated USD $550 million in 2010 [
14]. However, these numbers are not inclusive of most of the costs that occur at the state and municipal levels. Most cases are individual ones (only around 3% are collective) that focus on access to health care services (mostly drugs), and the success rate for these litigants is high [
15]. A growing body of evidence shows that judicialization accentuates inequalities in the health system. Most of the court orders are in states with the highest Human Development Index [
15], and evidence from the municipality of São Paulo show that litigants tend to originate from the neighborhoods with the lowest levels of exclusion or social vulnerability [
16].
2
The legal system may, however, be a slow and costly mechanism for making decisions about health care coverage. Whether the right to health is delivered is determined in the more complex world of how services are organized and delivered, where advances in the right to health could arguably be made through improvements in systems and management in some cases without additional resources. To operationalize the right to health, it is therefore critical to understand and ensure if and how the health system is fair [
8], and if and how it provides equal opportunity for all [
17].
Empirical assessments of equity and the right to health tend to emphasize simple measures of access or utilization of services. Similarly, much of health-related litigation focuses on access to specific drugs or procedures. However, these empirical perspectives and manifestations of a rights-based approach belie the significant inequalities and rights violations that arise in the case of more complex health needs such as cancer. To shed light on these issues, the paper focuses on the care pathways for breast and cervical cancer and explores access and quality issues that arise at different points of the care pathway and at different levels of the health system with implications for the realization of the right to health in Brazil.
Cancer is a growing health challenge in Brazil and the annual number of deaths from cancer increased from fewer than 100,000 in 1990 to around 200,000 in 2013, representing 17% of all deaths [
18]. Estimates of incidence rate for 2018 show that with the exception of non-melanoma skin cancer, breast (29.5%) and cervical cancer (8.1%), together with colorectal cancer (9.4%), are the most common cancers for women [
19]. With the large anticipated increase in the number of elderly in Brazil (the share of the population 60 years and older is projected to increase from 10.2% in 2010 to 29.3% in 2050 [
20]), the number of cancer cases is likely to increase in the future. Furthermore, lawsuits related to cancer care represent a significant part of litigation and are a growing burden on the public purse [
21‐
23]. It is therefore important to understand the performance of SUS related to cancer care.
Previous literature focuses on measuring delays in cancer care and casual factors related to delays, primarily for breast cancer [
24‐
28]. Studies in various states show that a large proportion of women with breast cancer are diagnosed in late stages (II-IV) [
24,
25,
27]. There is only one national study to date that shows that 60% of cancer patients received their diagnosis in a late stage (III or IV) and only 15.9% of patients received treatment within 30 days, with an average wait time for radiotherapy of 113.4 days in 2010 [
28]. Factors related to late diagnosis include lack of patient awareness of cancer symptoms, difficulty in obtaining access to diagnostics procedures and specialist care [
24,
26,
28] and deficiencies in primary care [
28]. Simon et al. (2009) find that patients diagnosed with breast cancer in public institutions and in the poorer north of the country were diagnosed at later stages than those diagnosed in the private sector and in the wealthier south of Brazil [
27].
The paper contributes to this field of research by providing new analysis of administrative data in a number of areas including waiting times, stage of diagnosis, and measurements of productivity of cancer care by state and region along the patient care pathway. In addition to updating and expanding information in the only available national study from 2011 [
28], it includes additional information on prevention, screening and diagnosis, various productivity measures, and analysis along socio-economic dimensions where data permits. Based on qualitative data from one state (Bahia) it sheds light on the underlying factors behind the patterns observed in the quantitative data. More broadly, the paper highlights the importance of health system analysis for exposing, empirically, rights violations and ultimately the distribution of health and ill health within and across societies.
Methods
The paper focuses on the patient care pathways for breast and cervical cancer and explores access and quality issues that arise at different points of the care pathway and at different levels of the health system with implications for the realization of the right to health in Brazil.
The paper uses a mixed method with triangulation of national quantitative data and qualitative information from one state (Bahia). The study is primarily based on analysis of administrative data collected at both national and state levels through cancer information systems (SISCOLO and SISMAMA) and provider-based record systems.
SISCOLO and SISMAMA are national information systems for cervical and breast cancer and capture information of results from both diagnostic and screening exams (mammography and Pap smear) and pathological exams of the breast and uterus (biopsy and surgical specimen). These systems contain data from public providers, private providers contracted by the SUS, states and municipalities. They are comprehensive and reliable for publicly financed health care in Brazil. However, SISCOLO and SISMAMA do not cover an estimated 24.4% of the population with private health insurance that access health care through private providers and may therefore not adequately represent the more affluent states in the south (e.g. Federal District, Sao Paolo and Rio de Janeiro) where private health insurance is high (above 20%) [
29].
Official population-based parameters were used to estimate health service needs, with adjustments made to account for the share of population covered by private health providers. The parameters to estimate those needs were based on official guidelines from the Ministry of Health (MOH), protocols for screening and treatment and guidelines from the Brazilian National Cancer Institute (INCA). Furthermore, national data from the Outpatient Information System (SIA) provided data on procedures outside the hospital, while the Hospital Cancer Registry (HCR) was used to capture advanced diagnostics procedures, surgery and other treatment procedures administered at the hospital level. Data on infrastructure, health professionals and other elements of the health system was obtained from the Registry of health facilities (Cadastro Nacional de Estabelecimentos de Saúde [CNES]) to analyze resources available for cancer care. Data from the national household survey (Pesquisa National por Amostra Domicililos [PNAD]) was also used in the study. Data from HCR and CNES covers all health facilities in the country, including privately owned facilities, and is national representative. Data related to the delivery of cervical and breast cancer care was collected from these various national administrative systems and analyzed to characterize the realization of the right to health for these two cancers in Brazil. A summary description of national data sources is included in Table
1.
Table 1
Summary description of national data sources
National information systems for cervical and breast cancer (SISCOLO/SISMAMA) | Information systems for cervical and breast cancer until 2012, when they started to be integrated in new cancer information system (SISCAN). The information system is fed by public providers, private providers contracted by the SUS, states and municipalities. The system captures data on the results of mammography, Pap smear exams and pathological exams of the breast and uterus (biopsy and surgical specimen). | The system suffers from delays in data entry and incomplete data for some variables (with variation across states). |
Hospital Cancer Registry (HCR) | Fed by hospitals and provides the basis for financial transfers to providers. Captures advanced diagnostics procedures, surgery and other treatment procedures that are administered at the hospital level. | Given the link with financial transfers, data tends to be more complete. Incentives for over-reporting exist but are mitigated by control and auditing systems. |
Outpatient Information System (SIA) | Covers all procedures provided outside hospitals. Data entered by providers. Provides the basis for financial transfers to providers. Includes data on all outpatient procedures. | Given the link with financial transfers, data tends to be more complete. Incentives for over-reporting exist but are mitigated by control and auditing systems. |
National Household Sample Survey (PNAD) | Is the national household sample survey conducted by Brazilian Institute of Geography and Statistics since 1981. The study draws on national representative data from the health section. | 2008 was the last time the health section of PNAD was conducted. New data, including the health module, was collected in 2018 but is not yet available. |
Registry of health facilities (CNES) | The system provides infrastructure information, type of care provided, specialized services existing beds and the number of health professionals in health facilities. | Although the CNES provides information on infrastructure and HR, it does not contain data on performance. |
Parameters of needs | The parameters to estimate the needs in the study have been based on official guidelines from MOH described in different ordinances (1101/2002 and others), protocols for screening and treatment and guidelines from INCA. | MOH has calculated those parameters based on scientific literature and previous years data. |
To compliment the quantitative analysis and gain more insights into the organization of cancer care, qualitative data was collected in the state of Bahia. Bahia is an important state in northeast Brazil, which has a population of 14.3 million people, with about 2.6 million (1.1 million) citizens living below the moderate (extreme) poverty line. Bahia was chosen after consultations with the MOH and INCA because it represents an average performing state in cancer care. Given the large size of the state it was necessary to narrow the geographical scope of the qualitative study to one of Bahia’s nine health macro regions – the east macro region. This region was selected because it represents diversity both in terms of geography and economy and it is also where the state capital is located with important cancer facilities that receive referrals from other municipalities in the state. The east macro region has four health regions (Camaçari, Cruz das almas, Salvador e Santo and Antônio de Jesus) and 48 municipalities and is home to 4.4 million people.
The study in Bahia was based on document analysis, data from SUS information system, roundtable discussions with health workers, structured interviews and focus group discussions with staff working in health care administration in the state, and semi-structured interviews and direct observations in health facilities. To better understand the organization of cancer care and the situation facing HWs, and identify challenges perceived by the HWs, roundtable discussions with HWs were conducted in the four health regions of focus.
Three roundtable discussions were held in each health region with a total of 116 participants. Data collection took place from July to September 2014. At least one HW from each of the four areas (primary care, specialized care, regulation and control and information systems) was selected by the local manager to get diverse perspectives. The questionnaires used during the roundtable discussions were designed in collaboration with managers and technical staff from the MOH, INCA and the State Heatlh Secretariat of Bahia (SESAB). The discussions were led by a Brazilian researcher and focused on the following topics: policy context at the federal and state level, the characterization of the network of cancer care for the two cancers and system performance measures. A summary description of qualitative data collected in the state of Bahia is included Additional file
1: Table S1.
An innovative feature of the study was that realistic patient cases were discussed, and specific questionnaires were used to identify patient pathways and obstacles to accessing care during roundtable discussions. To identify weaknesses in system design and identify patient pathways, structured interviews (based on questionnaires focused on access, regulation, contracting and primary as well as specialized care) and focus-group discussions were undertaken with 17 participants from SESAB, the municipality of Salvador and the State Center for Oncology. Direct observations and semi-structured interviews at the facility level were conducted in three facilities to identify how to get access to screening tests, specialized appointments, etc. All interviews and roundtable discussions were recorded, transcribed and analyzed. Furthermore, administrative data was examined, and a review of policies and programs was conducted. Equity in access to care was explored and considered throughout the analysis of the data. The preliminary results of the study were also presented and discussed with policy makers in Bahia and at the national level to confirm the results and strengthen the rigor of the analysis. The study was approved by the Research Ethics Committee of SESAB under No. 091582/2014, and participants agreed to be part of the study by signing the Informed Consent Form.
Discussion
Through this empirical assessment on equity and the right to health along patient care pathways for breast and cervical cancer in Brazil, it is shown that patients’ right to health is systematically violated at different stages of the patient pathway.
In terms of early detection and screening, the analysis reveals that at the national level only 65% and 54% of the estimated need for mammography exams and Pap smear exams respectively is met. There is large variation across states in the extent to which screening needs for breast and cervical cancer are met, with a tendency for lower screening rates among the poorest groups of society. Also, coverage rates of breast cancer screenings are higher in states that are better off economically. Half of mammography screenings is outside the target population, which may be caused by implicit prioritization by health workers. This represents waste and could potentially be harmful for women who could get exposed to unnecessary radiation associated with mammography. Quality of cervical cancer diagnostics procedures is also a key concern: almost half (46%) of collected samples for cervical cancer screening is never completed, with consequences for patients, who face repeated tests and the stress that this implies. This is an important contributor to low screening rates for cervical cancer and raises concern about the training and knowledge of healthcare workers in this area, the coordination between primary care providers and diagnostics providers and the quality of laboratory services.
The patients’ right to
accurate diagnosis at an early stage is also violated. The analysis confirms findings of previous research [
28] and shows that few cases of breast cancer (26%) and cervical cancer (39%) are diagnosed at an early stage (stage 0 or I), thereby reducing the survival prospects of patients. There is large variation in performance among states, particularly for early diagnosis of cervical cancer, with a tendency of poorer states faring worse than wealthy states in terms of early diagnosis of the two cancers. Contributing factors to late diagnosis include: challenges with the quality of diagnostic exams for cervical cancer, low access to specialist care and more sensitive diagnostics procedures (e.g. biopsy and FNA) needed to confirm diagnosis and no effective prioritization of patients with advanced cancer in confirmation of diagnosis.
While the right to prompt access to treatment is now codified in the law that guarantees treatment within 60 days of confirmed diagnosis, the study shows that waiting times are not systematically collected and monitored along the patient pathway. Available data on the time between confirmed diagnosis and treatment suggests that waiting times are long and depend on patients’ health-seeking behaviors. Waiting times are significantly longer for patients that follow the recommended patient pathway and are diagnosed outside the hospital compared to these who seek care directly at the hospital level and receive both diagnosis and treatment in a hospital (76 vs. 29 days for breast cancer and 82 vs. 29 days for cervical cancer). For patients that go through the recommended patient pathway, i.e. diagnosis outside the hospital and referral to treatment in the hospital, most of states have difficulty meeting the 60-day waiting time guarantee stipulated in the law. While data is not available on the socio-economic status of patients for this variable, this finding may be a sign that patients who are less informed and weak may fare worse in a system where the recommended pathway does not deliver on timely cancer treatment. Consistent with the long waiting times and the advance stage at which many women receive confirmed diagnosis, a larger share of women starts treatment with chemotherapy (82.2%), the most common treatment when the cancer is detected late, compared to surgery (50.6%).
The paper shows how inequalities and rights violations are the result of complex interactions of different parts of the health system. At first glance, Brazil is relatively well resourced from an international perspective as far as oncologists per capita and availability of technology for effective cancer care are concerned. However, detailed analysis reveals that availability of equipment does not necessarily translate into execution of services as e.g. mammogram machines produce below capacity. The unequal distribution of oncologists and cancer hospitals across the country are likely contributing to difficulties and delays in physical access to cancer care observed in the study. An in-depth capacity utilization assessment could be useful to better understand existing capacity constraints and monitor the use of equipment, facilities and workforce dedicated to cancer care.
The paper also shows that important data points are not available, e.g., the financing of cancer care. This makes it difficult to draw firm conclusions on the health system determinants for delivery of cancer care.
Yet, this type of detailed health system analysis, not only exposes systemic inefficiencies along the patient pathway, it also sheds light on how these inefficiencies can be addressed to improve the right to health. For instance, several measures can be taken to reduce waiting times and provide prompter access to treatments. The coordination of care between the primary care level and the hospital level as well as units carrying out diagnostics procedures could be improved by establishing clear accountability frameworks and incentives for compliance with agreed rules, fast-track pathways for patients with advanced cancer could be introduced, and the use of existing oncologists and cancer care hospitals could be optimized and become more productive.
A key limitation of this study is the lack of data along many dimensions such as race, sexuality and in some cases socio-economic status. The analysis showed that when such analysis could be completed, e.g. for coverage of screening for breast and cervical cancer, SUS is not fair, nor pro-poor. Investments in better data and more systematic use of the same is therefore not just important to improving the management of the health system but also to assess health equity in a specific area or to monitoring rights violations. In the case of Brazil, a population-based national cancer registry is critical to better monitor the equity of cancer care. Patient-based surveys, with questions related to cancer care, could also be administered on a regular basis to determine how well the system serves its citizens. Improved information systems and use of data by HWs could enhance coordination of care and better data on e.g. waiting times and treatment choices, would allow for health system performance monitoring and national and international benchmarking.
Judicialization is potentially an important tool to ensure effective coverage of interventions and the maximization of equity in access to quality of care. With this paper we argue that detailed health system analysis along the patient pathway, with data that is disaggregated along axes of gender, race, socio-economic status, sexuality, and disability, can provide a powerful complimentary tool in research on the right to health. Health system research is valuable because it can pinpoint exactly how and where citizens’ right to health is violated in practice and provide strategies to address these issues. It can also be used to engage citizens and patient groups and give them voice and evidence to argue their case and thereby open doors for popular input to shape health policy and hold states and other parties accountable. Giving voice to vulnerable populations and enabling them to change their conditions of vulnerability are critical pieces of the human rights-based approach [
34]. As pointed out by Yamin (2014), health systems are social institutions whose design and organization depends on political struggles, which ultimately determine what health outcomes they produce and how health and ill health are distributed across citizens in societies [
8].
Acknowledgements
Authors would like to acknowledge the contribution of Maria Do Carmo Esteves da Costa, Fernanda Paula Sousa, Claudia Furia Cesar, Cristiane Castro, Fernanda Paula Sousa, Larissa Verissimo, Otavio Ferraz, Pedro Pairazaman, Saskia Nahrgan and Ezau Pontes. Mario Henrique Neiva Saraiva and Ashleigh Dunworth provided excellent research assistance. Authors are grateful for significant technical input and logistical support for the fieldwork in Bahia from all the involved municipalities (Salvador, Saubara, Vera Cruz, Camaçari, Ipojuca, Dias d’Ávila, Santo Antônio de Jesus, Amargosa, Itatim, Cruz das Almas, Governador Mangabeira e Maragogipe), as well as from the many health professionals and health system managers that participated in the process. Lastly, we would like to thank two anonymous reviewers for valuable suggestions and comments.