The fifth floor of the State Department of Health building in downtown São Paulo is where, on any given day, you will find attorney Renata Santos and her team of 35 as they deal with the benefits and obstacles that arise from one of the greatest challenges to face public management in recent times: the supply of medicines mandated by court order. In the last five years, there has been a 92% increase in the number of legal proceedings brought by patients to compel the State to provide drugs and treatments that are not offered under the Brazilian Unified Health System (SUS) or that have not yet been registered in Brazil. In 2015 alone, the São Paulo State government spent R$1.2 billion on medicines and pharmaceutical supplies for 57,000 patients who had gone to court. “This sum is almost enough to keep the Hospital das Clínicas [at the School of Medicine of the University of São Paulo (HC-FM-USP)], which treats 35,000 patients a day, running for a year,” says Santos.
The phenomenon known as judicialization of health is multifaceted. On one hand, legal actions commit a significant portion of the budget to meet the specific demands of some patients; on the other hand, they can represent the only path forward to save or prolong the lives of patients, especially those suffering from rare or chronic diseases, such as diabetes or cancer, who depend on costly medications. There is also the use of this last resort for medicines that are equivalent to those available under the public health system, or even to purchase products such as diapers or coconut water—always through prescription. In recent years, the team from the state health department has worked with researchers from São Paulo universities to establish information systems that could support decisions by judges and industry administrators as a way to promote inclusion of medicines most frequently requested under the public system.
The partnerships between teams from the state health department and research institutions receive support through a computer program called S-Codes, established in 2010 by the Office of Coordination of Strategic Demands (CODES) of SUS, part of the São Paulo State Health Department that manages the lawsuits brought against the state of São Paulo. The S-Codes program has demonstrated that 60% of the court rulings stem from prescriptions from physicians in the private health system, in other words, from offices, clinics and private hospitals. An assumption supported by Santos to explain this fact is that, generally speaking, private network physicians are not familiar with health laws and the list of drugs included under the public network, the Brazilian Ministry of Health’s Essential Medicines List (RENAME). “This is why,” she says, “therapeutic alternatives already available under SUS, similar to those requested, end up being overlooked by physicians.”
The S-Codes program has become a key element in studies conducted under the scope of the Research in Public Policies Program for the National Health Care System (PP-SUS), funded by the Ministry of Health in partnership with the National Council for Scientific and Technological Development (CNPq) and led in São Paulo by FAPESP and the State Department of Health. The program supports research studies aimed at vital health problems and at strengthening SUS management in São Paulo. In recent years, the issue of judicialization of health has gained prominence among research projects presented to the program. In one of them, accountant Carlos Alberto Grespan Bonacim, a professor in the USP School of Economics, Business Administration and Accounting in Ribeirão Preto, examined the socioeconomic profile of patients based on a sample of approximately 900 lawsuits filed from 2013 through June 2015, leading to the release of nearly 8,000 medicines in 27 municipalities of the Ribeirão Preto region. The city is one of three having the highest rate of health lawsuits in the state–the others are Barretos and São José do Rio Preto.
On the basis of the S-Codes, Bonacim found that 66% of the medicines obtained through court order were not on the SUS list. The remaining 34% were already being supplied through the public network, but the patients had either requested versions produced by other companies, or those that reflected certain technological improvements. Another study, this one by Brazilian anthropologist João Biehl at Princeton University, published in 2016 in the Health and Human Rights Journal, found that out of a total of 3,468 medicines requested through lawsuits filed against the state of Rio Grande do Sul in 2008, more than half (56%) were supplied under the SUS.
Physicians and researchers say that it is not always the latest generation of medicine that is the most effective among those already adopted by the SUS. One example is at the A.C.Camargo Cancer Center, in São Paulo, which provides care through the SUS and through private consultation. Patients treated by private providers may have access to two new medicines used to treat breast cancer: trastuzumab emtansine and pertuzumab. When associated with chemotherapy, they can prolong a woman’s life from three to five years. Although they were approved in 2014 by the National Health Surveillance Agency (ANVISA), the Brazilian federal agency that regulates the registration of food and medicines, and have been released for sale in Brazil, the two drugs were not approved by the National Committee for Technology Incorporation (CONITEC) in the SUS, an agency established in 2011 under the purview of the Ministry of Health, and are therefore not available through the public network. “Treatment with these medicines costs the patient nearly R$30,000 per month. The total cost of their inclusion under the SUS would be impracticable for the government, since every year, there are nearly 50,000 new cases of breast cancer in Brazil,” says Helano Freitas, clinical research coordinator at São Paulo’s A.C.Camargo Cancer Center. Even without access to these state-of-the-art drugs, users under the SUS treated at the hospital are not at a disadvantage. “Other medicines provided under the health system are equally effective and can increase patient survival,” he says. Freitas goes on to say that most patients at A.C.Camargo who resort to lawsuits to receive medications generally have more access to information and enjoy higher socioeconomic status.
But that is not always the case. The average income of patients filing lawsuits in the Ribeirão Preto region is just over R$1,000 according to the study by USP’s Bonacim. He says that this data helps show that judicialization is not a phenomenon related to just those at higher income levels. “Patients with fewer resources turn to the state’s public defenders who provide legal assistance at no charge.” Even so, 60% of the patients analyzed from the region of Ribeirão Preto hired a private attorney.
In the last seven years, the Ministry of Health has disbursed R$4.5 billion on the purchase of medicines, equipment, food supplements and the coverage of court-ordered surgeries and admissions (see graph). Most of these federal lawsuits originate in the Brazilian states of Minas Gerais, Santa Catarina, São Paulo, Rio de Janeiro and Rio Grande do Sul. Including costs to states and municipalities, the federal government calculates that expenditures for the purchase of medicines by court order reached R$7 billion last year. A substantial proportion of this amount was used for high-cost drugs. In 2016, the Ministry of Health spent R$654.9 million on the purchase of just 10 medicines to meet the demands of 1,213 people (see list). In São Paulo, 4% of the medicines use up more than 90% of the costs of that state’s lawsuits.
Anvisa registration
The list of the most expensive medicines purchased by the federal government includes six that are not registered with ANVISA. One of them is lomitapide, approved in the United States for use by those who suffer from a rare genetic disease known as homozygous familial hypercholesterolemia. Treatment using this medicine costs nearly $1,000 per day. The fact that a medicine is not registered with ANVISA means it has no official authorization to be sold on a large-scale in Brazil because, just as in the drug’s country of origin, it has not undergone all the preclinical and clinical trials—in animal and human models, respectively—necessary for ensuring its safety and efficacy.
“Judges do not generally have technical/scientific background on all aspects inherent to a medicine, such as regulation concerning its use, nor an intimate understanding of the SUS, which makes the drugs available according to scientifically established criteria,” says Maria Aparecida Nicoletti, a researcher at the USP School of Pharmaceutical Sciences. She is taking part in a PP-SUS project to adapt Spain’s Dáder method of pharmacotherapeutic monitoring of patients, in the School Pharmacy of USP (FARMUSP), with a view towards employing it in Primary Healthcare Units (PHU) in São Paulo and generating information to support the court orders. In this study, a group of patients with prostate cancer initially treated at the Hospital of the University of São Paulo with medicines already available under the SUS are now engaging in pharmaceutical consultations that assess the effectiveness of the drugs and possible interactions among them. “We’re working with patients who not only have cancer, but may also be suffering from depression, hypercholesterolemia, hypertension and cardiovascular problems that they are taking medicines for,” Nicoletti explains.
The researcher says that this method is being implemented in other parts of Brazil, although not extensively. “We need to step up pharmacotherapeutic monitoring, especially with regard to high-cost medicines, and to compile data and publish our findings,” Nicoletti says. She thinks that the method may also help monitor off-label drug use, a common issue in the lawsuits. The expression refers to situations in which the physician prescribes a medication to treat a condition for which the product was not originally designed. There are cases where off-label use ends up characterized as medical error, while in other cases it may work.
In municipalities
At the University of Sorocaba (UNISO), a research group is working within the PP-SUS to conduct pharmacotherapeutic monitoring of patients and develop a computerized system similar to that used by the state department of health. The difference is that JudSys, the name given to the program, focuses on demands from municipalities and includes a clinical module that allows organization of technical data concerning the use of medicines obtained through pharmaceutical consultations. “We ran pilot tests in municipalities in the Sorocaba region such as Votorantim and São Roque to assess feasibility and functionality of JudSys, and now we’re making adjustments to offer it to other interested municipalities,” explains pharmacist Silvio Barberato Filho, a UNISO professor and project coordinator.
Last year, Barberato’s group began a partnership with the Pharmacy School of the University of Brasília (UnB), in the Federal District, to test the JudSys clinical module. There, 15 diabetic patients are being monitored for their use of insulin analogs, one of the medicines most often sought through court order. Just as at USP, patients at UnB are treated by pharmacists who record data about use of the drugs and make recommendations. The results of the monitoring are expected to be organized in the coming months and new data about insulin analog use will be published. “Insulin analogs were not incorporated under the SUS but some states and municipalities have defined clinical protocols and included the medicines on their local lists,” Barberato says.
Concern about the impact of judicialization in municipalities is justifiable. There are cases in which a single lawsuit can compromise a small city’s entire health budget. Some initiatives are seeking to get around this through institutional arrangements. One of the most memorable examples involved Santa Catarina State. In 1997, 25 municipalities in the vicinity of the city of Lages, 200 kilometers from Florianópolis, joined forces to find better ways to manage their health resources, frequently affected by judicialization. Mayors and city managers had realized that it was much more difficult to deal with court orders on their own. Through an inter-municipal consortium, they established a common standard of action that prevented overlaps in requests and streamlined expenses and investments, this according to Roseni Pinheiro and Felipe Asensi, professors at the State University of Rio de Janeiro (UERJ), in an article published in the Revista de Direito Sanitário in July 2016. The article emerged from a study coordinated by both Pinheiro and Asensi in partnership with the National Council of Justice (CNJ).
In 2012, the consortium launched the Medicine Reconciliation Center to handle requests for drugs that had not yet been sought through legal channels. In a room made available by the Lages city hall, a multidisciplinary team talks to patients interested in filing lawsuits, suggests the use of generic versions of the medicines they requested and advises replacing the physician who wrote the prescription, before the request makes its way to the courts. According to the researchers, “the integration between state and municipal health agencies, patients, public defenders, public advocacy groups and federal prosecutors has led to a reduction in the number of legal disputes.”
Eduardo Cesar
Prostate cancer patient undergoes pharmacotherapeutic monitoring at the School Pharmacy of USP, in São PauloEduardo CesarIn São Paulo, an initiative announced in December 2016 is also seeking to promote interaction between participants involved in court requests for medicines. The State Department of Health, the Supreme Court, the Office of the Public Prosecutor and the Office of the Public Defender have executed a cooperation agreement that establishes a protocol for the flow of triage services and pharmaceutical advice to SUS users. “The idea is for trained professionals to assess physicians’ prescriptions before the patients make a decision to file a lawsuit with the courts. It is a way to verify the possibility of presenting the physician and patient with alternative therapies supplied under the SUS, when possible,” explains Sylvio Ribeiro de Souza Neto, assistant judge on the São Paulo State Supreme Court (TJSP). Renata Santos, at the department of health, believes the initiative is an opportunity for dialogue between public administrators and the judicial branch. “We would like the judges to understand that the health department wants to treat patients using the best medical techniques available, without economic restrictions. We have a budget to be used on health. What we are looking for are the best ways to use these public funds to serve the largest possible number of people,” she says.
Also in late 2016, the CNJ and the Ministry of Health, in partnership with the Hospital Sírio-Libanês, announced a project to expand judges’ use of science-based information and improve judgments in legal disputes. The agreement calls for the expansion of Health Technology Assessment Centers (HTAs) whose task is to assist courts throughout Brazil by issuing opinions and technical notes about medicines. In November 2016, the first HTA training and development workshop brought together court representatives from 10 states in Brazil. “We addressed topics such as drafting and standardizing technical notes,” says Luiz Reis of the Hospital Sírio-Libanês, where the meeting was held.
According to Arnaldo Hossepian Salles Lima Junior, advisor to the CNJ and supervisor of the National Forum on Health, the partnership with the hospital includes establishing a database containing technical information based on scientific evidence that can be accessed by judges all over Brazil. “The idea is that before making any decision, the judge would consult the database available on the CNJ website and access information about medicines, procedures and the like that are part of a patient’s request. Armed with this information, the judge could know, for example, if there is a similar drug under the SUS and if the requested drug is really effective,” Hossepian explains. The Hospital Sírio-Libanês is expected to invest nearly R$15 million over three years to build the framework for the platform. The scientific information that will be fed into it will be provided by opinions issued by the HTAs, CONITEC and the Cochrane Center, an international organization based in Copenhagen, Denmark that analyzes series of clinical studies in search of evidence of treatment efficacy.
In September 2016, the CNJ approved a resolution that provides for the establishment and maintenance of the State Health Committees, already set up in some states, whose role is to discuss health issues and assist the work of the judges. One of the most active committees is from the state of Minas Gerais and is made up of members from the federal and state judiciary and representatives from health plans, the Office of the Public Prosecutor, the Santa Casa Hospitals and universities including the Federal University of Minas Gerais (UFMG). Osvaldo Firmo, chief justice on the Minas Gerais State Supreme Court (TJMG) and a member of the state health committee of the CNJ, points out that the judges place high value on technical guidance. “The trouble is that no one wants to run the risk of being complicit in anyone’s death,” he remarks. The committee’s website provides a series of recommendations for the judges, in addition to technical notes and links to books and articles about judicialization.
Sylvio Ribeiro of the TJSP recalls the time he spent on the front lines, judging health cases. “No matter how much scientific data we have at hand, it’s distressing to know that a negative response from us can lead to the loss of health or even to someone’s death,” he says. Renata Santos from the state health department asserts that the patient’s defense is almost always based on the risk of death in the event that the medicine is not provided. However, the S-Codes have indicated that in a considerable proportion of court decisions there is no risk of irreparable damage to the patient.
Often, in addition to medicines, the legal requests include items already provided under the SUS such as disposable diapers, or that go beyond medical treatment, such as wet wipes, sunscreen and coconut water that physicians consider appropriate for their patients. For this reason, the health department has to provide 69 different kinds of diapers to 4,000 people, at an annual cost of R$12.6 million. “An increasing number of people are asking to buy medicines and products already available under the public system. The SUS supplies acetylsalicylic acid, but patients still go to court to request another brand of analgesic,” Santos says.
She does not rule out the influence the pharmaceutical industry plays as a premise for judicialization. Recently published studies show that the influence of companies in the industry extends to patient groups and associations. A research study published in January 2017 in JAMA Internal Medicine by Susannah Rose of Case Western Reserve University of Ohio, investigated nearly 300 patient advocacy groups in the United States and discovered that 67% of them had received funding from pharmaceutical companies in the past year. According to public authorities, there are signs that industry pressures are similar in Brazil and end up contributing to the increase in judicialization by creating new demands for medicines. Court orders also have other effects. “There are cases in which decisions by the courts have provided impetus to the SUS in instances where repeat awards for a single drug or procedure alerted them to the need for inclusions of technology and medicines,” Santos says.
Rare diseases
For those who suffer from rare diseases, legal channels may be the only way to obtain extremely expensive medicines. One example involves patients who suffer from paroxysmal nocturnal hemoglobinuria, a rare type of inherited anemia that causes such illnesses as chronic kidney disease and pulmonary hypertension. The medicine indicated in this case is eculizumab, whose brand name is Soliris, still pending registration by ANVISA. In 2016, Soliris represented the largest expense to the Ministry of Health in lawsuits: R$391.8 million to treat 336 patients.
One argument commonly used by patients who turn to the courts to obtain the so-called exceptional medications, which are very expensive, is rooted in the Federal Constitution, according to which health is a right of all and a duty of the State. “The problem is that the individual right is outweighing the collective right,” says Luiza Heimann, director of the São Paulo State Institute of Health, an institution associated with the state health department that conducts health technology assessment studies. “Caring for the health of citizens does not mean looking after the health of the sum of all sick individuals. It means coming up with a plan based on the population’s epidemiological profile,” Heimann explains. She says that every four years, a National Health Conference is held where SUS managers, employees and representatives of organized civil society set SUS priorities for the coming years, on the basis of epidemiological studies. For Judge Osvaldo Firmo of the TJMG, this means that health policies have to ensure the entire population equal access to treatment, without preference. “The procedures for adding medicines in Brazil comply with the criteria that favor the purchase of large volumes of medicines for the greatest possible number of people,” Firmo says.
In industrialized nations, especially in Europe, the problem of judicialization is practically nonexistent. “Countries like Italy, France and the United Kingdom have universal health systems that have matured over the decades,” explains José Gomes Temporão, Minister of Health from 2007 to 2011. “The population of those countries knows there are limitations on the State’s ability to provide medicines. Patients accept the treatment available under the system and do not even entertain the notion of filing lawsuits, except in extreme cases such as in rare diseases,” Temporão says. In the view of Denizar Vianna Araújo, a researcher at UERJ, the judicialization of health has been an essentially Latin American phenomenon. “Faced with a ‘no’ from the government, citizens are encouraged to seek salvation in the court system. It is a strong cultural trait in Latin American countries,” he says.
Cláudio Cordovil, a researcher at the Sergio Arouca National School of Public Health at the Oswaldo Cruz Foundation (Fiocruz) in Rio de Janeiro, defends the need for changes in the system for adding medicines for rare diseases in Brazil. He says that the HTAs conducted by CONITEC to determine the addition of medicines covered under the SUS were originally established to make decisions about drugs intended to serve a large number of people. To Cordovil, the use of conventional HTA methodologies in the context of rare diseases, which affect specific groups of patients, is one of the factors that is promoting judicialization in Brazil. “If we apply conventional methodologies to decide on medicines for rare diseases, in practice we will never include any of these drugs under the SUS. The international literature has unequivocally determined this,” the researcher says.
Renata Santos is also using S-Codes to collect other little-known data about the consequences of purchasing medicines by court order. “Twenty to thirty percent of the patients who file lawsuits in São Paulo do not come to retrieve the medicine released by the courts,” she says. “Aside from the cases in which patients have died, the main reason for not getting the medicine is that the person changes his mind, withdraws from the treatment and chooses something else.” When possible, the department directs the drug to another patient, although more than half of the requests are for exclusive use, that is, each drug is prescribed for use by only one person. “When the patient does not come to pick it up,” she says,” we store the medicine and once it expires, we have to burn it.”
Projects
1. Management of health litigation in municipalities: a pharmacotherapeutic follow-up model (nº 2014/06038-2); Grant Mechanism Regular Research Grant; Principal Investigator Silvio Barberato Filho (UNISO); Investment R$ 103,297.39.
2. Factors affecting the process of health care litigation on the Regional Division of Health – DRS XII (nº 2014/50040-1); Grant Mechanism PP-SUS Grant; Principal Investigator Carlos Alberto Grespan Bonacim (FEARP-USP); Investment R$ 7,325.37.
3. Pharmacotherapeutic follow-up at the School Pharmacy of the University of São Paulo (nº 2012/51707-4); Grant Mechanism PP-SUS Grant; Principal Investigator Silvia Storpirtis (FCF-USP); Investment R$ 253,692.76.
Scientific Articles
BIEHL, J. et al. The judicialization of health and the quest for accountability: Evidence from 1,262 lawsuits for access to medicines in Southern Brazil. Health and Human Rights Journal. June 2016.
ASENSI, F.; PINHEIRO, R. Judicialização da saúde e diálogo institucional: A experiência de Lages (SC). Revista do Direito Sanitário. V. 17, No. 2, 2016.
