Human Rights Law Review-2015-Wang-hrlr - ngv025

Human Rights Law Review Advance Access published October 1, 2015
Human Rights Law Review, 2015, 0, 1–25

doi: 10.1093/hrlr/ngv025
Article
Right to Health Litigation in Brazil: The

Problem and the Institutional
Responses
Downloaded from http://hrlr.oxfordjournals.org/ at University College London on November 9, 2015

Daniel Wei L. Wang*
ABSTRACT
This article first analyses how courts, by applying the right to health as a trump against
rationing decisions, have become a relevant healthcare policymaker in Brazil. Based on
empirical findings, it argues that right to health litigation makes the Brazilian public
health system less fair and efficient. It then discusses three responses to the negative
impact of litigation on the health system: the public hearing held by the Supreme
Federal Court and the test established thereafter; the recommendations by the
National Council of Justice aimed at building courts’ institutional capacity; and Federal
Law 12.401/11, which created a new health technology assessment system. Based on a
comparative institutional analysis, it concludes that the latter response is the most
adequate because it keeps the substantial decisions on the allocation of healthcare
resources in the institution that has better capacity to make them and facilitates the
judicial control of procedure.
K E Y W O R D S : right to health, social rights, Brazil, health technology assessment
1. INTRODUCTION
Imagine a healthcare policy with the following features: scientific evidence plays almost
no role in it because stringent analysis of treatments’ effectiveness or safety is not an
essential requirement; treatments’ cost-effectiveness will not be assessed either and
hence efficiency in the public spending is ignored; the distribution of beneficiaries is
not made according to any reasonable principle of distributive justice, but rather to an
individual’s capacity to litigate; and no matter if other needs are more urgent, the pos-
sibility of alternative use of the resources, or the preference of elected representatives,
public authorities or other stakeholders, this policy has to be implemented. From any
perspective, this would be a bad healthcare policy and would never fulfil the re-quire-
ments of a fair and efficient public health system. However, this is how Brazilian courts
are allocating a significant amount of the public resources when enforcing the right to
health as an individual trump against healthcare rationing decisions.
* Assistant Lecturer, Queen Mary University of London ([email protected]).
C The Author [2015]. Published by Oxford University Press.

V
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1
2 Right to Health Litigation in Brazil
The Brazilian Federal Constitution declares that the right to health is a fundamental
right of all and a duty of the State, and established a public health system based on the
principles of universality, equality of access and comprehensive coverage (Article
196-8). Brazilian judges were also given the power to consider any case in which a
right is threatened or violated (Article 5, XXXV), and a claim against the State can be
issued via ordinary actions, class actions (ação civil pública), a protection writ against
public authorities (mandado de segurança) and special procedures in small-claim courts
(juı́zados especiais), where legal representation is not necessary. These constitutional
and jurisdictional provisions have entitled citizens who were denied a certain health
treatment by the public health system to sue the State claiming that they have the right

to receive the treatment they need from or funded by the public health system. This
phenomenon will be called right to health litigation in this article.
Right to health litigation in Brazil has already been discussed in the literature on
social rights adjudication.1 This article, however, presents a more comprehensive
review of the empirical findings which provides more solid grounds for answering
three questions: what is demanded by claimants? What is the economic impact of
the decisions on the public health budget? And how do courts judge these cases?
The data reveals that litigation in Brazil has reached an impressive scale and has
made the courts a major player in the allocation of healthcare resources, but in a way
that makes the public health system less fair and efficient.
The second part of this article compares three responses and the institutions they
create to control the negative impact of litigation on the public health system: (i) the
public hearing held by the Supreme Federal Court (STF) and the test established
thereafter to define a sphere of judicial self-restraint; (ii) the recommendations
by the National Council of Justice (CNJ) aimed at building courts’ institutional
capacity; and (iii) the enactment of Federal Law 12.401/11, which created a new
health technology assessment system.
Claims for the provision of health treatment, although not necessarily using the lan-
guage of the right to health, are certainly not a phenomenon restricted to Brazil. In
many jurisdictions the expansion of judicial power to cover issues of social policies, the
increase in the cost of healthcare and better informed and less acquiescent patients
have all brought discussions about priority setting in healthcare to the courts that in
the past had been entirely left to the discretion of legislatures and health authorities.2
1 See Ferraz, ‘The Right to Health in the Courts of Brazil: Worsening Health Inequities?’(2009) 11 Health
and Human Rights 33; Ferraz, ‘Harming the Poor Through Social Rights Litigation: Lessons from Brazil’
(2012) 89 Texas Law Review 1643; Ferraz, ‘Brazil. Health Inequalities, Rights and Courts: The Social
Impact of the Judicialization of Health’ in Yamin and Gloppen (eds), Litigating Health Rights: Can Courts
Bring More Justice to Health? (2011); Prado, ‘The Debatable Role of Courts in Brazil’s Health Care
System: Does Litigation Harm or Help?’ (2013) 41 The Journal of Law, Medicine & Ethics 124; Hoffman
and Bentes, ‘Accountability and Social and Economic Rights in Brazil’ in Gauri and Brinks (eds), Courting
Social Justice: Judicial Enforcement of Social and Economic Rights in the Developing World (2010).
2 See Hogerzeil et al., ‘Is Access to Essential Medicines as Part of the Fulfillment of the Right to Health
Enforceable Through the Courts?’ (2006) 368 The Lancet 305; Yamin and Gloppen, supra n 1; Langford
(ed.), Social Rights Jurisprudence (2008); Landau, ‘The Reality of Social Rights Enforcement’ (2012) 53
Harvard International Law Journal 402; Norheim and Wilson, ‘Health Rights Litigation and Access to
Medicines: Priority Classification of Successful Cases from Costa Rica’s Constitutional Chamber of the
Supreme Court’ (2014) 16 Health and Human Rights Journal 47; Flood and Chen, ‘Charter Rights and
Health Care Funding: A Typology of Canadian Health Rights Litigation’ (2010) 19 Annals of Health Law
Right to Health Litigation in Brazil 3
The analysis of the case of Brazil in this article can offer important lessons for the
legal and policy debates on this worldwide phenomenon. First, it presents robust empir-
ical data to show how and why adjudicating health rights, at least via individual com-
plaints, can create an overall undesirable outcome for a public health system by making
it less fair and efficient. Secondly, the comparison between the different institutional
responses to right to health litigation challenges the expediency of the idea proposed by
part of the literature on social rights adjudication that courts should build their own
institutional capacity to adjudicate on social policy issues. Thirdly, it argues that a robust
health technology assessment system creates strong reasons for courts, instead of allo-
cating healthcare resources themselves, to control authorities’ decision-making proc-

esses, which can make the health system more, rather than less, fair and efficient.
2 . R IG HT TO HE A LT H LI T I G A T I O N : UN F A IR NE S S A ND
INEFFICIENCY
This section analyses right to health litigation in Brazil based on empirical evidence
regarding what is demanded by claimants, how courts judge the cases, and the
economic impact of the decisions on the public budget.
Brazil is organized in a federal system and the analysis will be based on the data
about right to health litigation at the federal level and in the states of Santa Catarina,
Rio de Janeiro, Minas Gerais, São Paulo and Rio Grande do Sul.3 This is where most of
the right to health litigation in the country is concentrated.4 Litigation in the capital cit-
ies of three of these states, where the population is concentrated, will also be analysed.
A. What Is Demanded?
Right to health litigation is mainly driven by individual claims for new health technolo-
gies, especially drugs, which have not been incorporated in the national public health
system’s (SUS) pharmaceutical policy. The percentage of cases involving claimants
demanding drugs not incorporated in the SUS’s pharmaceutical policy is high: 80.6
per cent in the state of Rio de Janeiro5 and 92.5 per cent in the city of Rio de Janeiro.6
479; Flood and Gross, ‘Litigating the Right to Health: What Can We Learn from a Comparative Law and
Health Care Systems Approach’ (2014) 16 Health and Human Rights 62; Young, Constituting Economic and
Social Rights (2012); Fredman, Human Rights Transformed: Positive Rights and Positive Duties (2008);
Syrett, ‘Health Technology Appraisal and the Courts: Accountability for Reasonableness and the Judicial
Model of Procedural Justice’ (2011) 6 Health Economics, Policy and Law 469; Newdick, Who Should We
Treat: Rights, Rationing, and Resources in the NHS (2004).
3 In Brazil there is a national public health system, the Sistema Único de Saúde (SUS), and the responsibility
for provision of health services is shared by every entity of the Federation. Therefore, there are more than
5,500 municipalities, 26 states, the Federal District and the federal government that can be sued by patients
willing to access treatments not provided by the public health system. The Brazilian courts have constantly
decided that a citizen can judicially claim health treatment against any level of government: see Wang
et al., ‘The Impact of Health Care Judicialization in the City of São Paulo: Public Expenditure and Federal
Organization’ (2013) 48 Revista de Administração Pública 1191.
4 National Council of Justice, Relatórios de cumprimento da Resolução CNJ n. 107, available at: www.cnj.jus.br/
images/programas/forumdasaude/demandasnostribunais.forumSaude.pdf [last accessed 18 August 2015].
5 Pepe et al., ‘Characterization of Lawsuits for the Supply of ‘essential’ Medicines in the State of Rio de
Janeiro, Brazil’ (2010) 26 Cadernos de Saúde Pública 461.
6 Figueiredo, Análise dos medicamentos fornecidos por mandado judicial na Comarca do Rio de Janeiro: A
aplicação de evidências cientı́ficas no processo de tomada de decisão (Masters dissertation, Sergio Arouca
National School of Public Health, 2010).
Other articles, instead of analysing the percentage of lawsuits in which a non-

incorporated drug was demanded, have assessed the percentage of non-incorporated
drugs among all drugs judicially claimed—62.2 per cent in the state of Santa
Catarina;7 68 per cent in the city of Florianopolis;8 7 per cent and 66.2 per cent in the
state of São Paulo;9 and 38 per cent in the city of São Paulo.10
It is important to highlight the difference between these two methods for calculat-
ing the data. The second method—which counts the number of non-included drugs
among all those judicially claimed—underestimates the importance of claims for
non-incorporated drugs as the main driver of right to health litigation. In many cases,
patients demand more than one drug. For example, in the example of the state of

Rio de Janeiro it was found that among the drugs judicially claimed, 52 per cent
were not incorporated in the pharmaceutical policy.11 However, when analysing the
number of cases in which at least one of these drugs is claimed, the number rises to
80.6 per cent.
One plausible hypothesis to explain this difference is that when people litigate for
an expensive medicine, they make the most of their effort and include all the medi-
cines that are in the same medical prescription that contains the expensive drug that is
really motivating the litigation. In other words, drugs included in the pharmaceutical
policy are ‘free riders’ and are claimed together with drugs not provided by the health
system. Litigants would put forward such a claim because if they have a judicial deci-
sion in their favour, they will receive the drugs under more convenient conditions.
The Federal Government, for instance, when complying with a judicial decision, deliv-
ers the drug by mail to the patient’s house.12 Moreover, patients make sure that their
supply will not be interrupted, as may happen to other patients, since health author-
ities will not stop providing the drugs because contempt of court is a criminal offence.
In the state of São Paulo it was found that in 87 per cent of the cases in which patients
were litigating for drugs already provided by the public health system, they were also
claiming access to non-incorporated treatments.13
It was also noticed that, in many cases, patients went to court claiming drugs that
belong to the pharmaceutical policy because they were prescribed for off-label or
7 Pereira et al., ‘Situation of Lawsuits Concerning the Access to Medical Products by the Health
Department of Santa Catarina State, Brazil’ (2010) 15 Ciência & Saúde Coletiva 3551.
8 Leite et al., ‘Ações judiciais e demandas administrativas na garantia do direito de acesso a medicamentos
em Florianópolis-SC’ (2009) 10 Revista de Direito Sanitário 13.
9 Chieffi and Barata, ‘Judicialization of Public Health Policy for Distribution of Medicines’ (2009) 25
Cadernos de Saúde Pública 1839; Macedo et al., ‘A Technical Analysis of Medicines Request-Related
Decision-Making in Brazilian Courts’ (2011) 45 Revista de Saúde Pública 706.
10 Vieira and Zucchi, ‘Distorções causadas pelas ações judiciais à polı́tica de medicamentos no Brasil’ (2007)
41 Revista de Saúde Pública 214.
11 Pepe et al., supra n 5. See also Sant’Anna, Essencialidade e assistência farmacêutica: um estudo exploratório
das demandas judiciais individuais para acesso a medicamentos no Estado do Rio de Janeiro (Masters disserta-
tion, Sergio Arouca National School of Public Health, 2009).
12 Ministry of Health and The Federal Attorney General’s Office, Intervenção Judicial na Saúde Pública:
Panorama no âmbito da Justiça Federal e Apontamentos na seara das Justiças Estaduais, available at: www.
portalsaude.saude.gov.br/images/pdf/2014/maio/29/Panorama-da-judicializa—-o—2012—modificado-
em-junho-de-2013.pdf [last accessed 18 August 2015].
13 Wang et al., ‘Incorporating Drugs Through Litigation: The Case of the State of São Paulo’ (Annual
Meeting of the Law and Society Association, 2012).
off-protocol use.14 The former means the prescription of a drug for unapproved
clinical indications or to unapproved subpopulations; the latter is the prescription of
drugs that are incorporated in the SUS to patients who do not meet the clinical
criteria established by clinical protocols and guidelines. For instance, Macedo et al.
analysed claims for high cost drugs incorporated in the SUS and found that in 81.3
per cent of them the clinical guidelines and protocols did not recommend their use
for the claimant’s condition.15
There is also a small percentage of litigation claims concerning drugs that are not
registered with the Brazilian National Health Surveillance Agency (ANVISA), the
agency responsible for barring unsafe and unproven drugs for use in the country.16

In cases where courts order the provision of drugs not registered with the ANVISA
or where they authorize off-label use, the court is ordering the provision of treat-
ments of which the safety and effectiveness has not been evaluated or approved by
the agency.
In these cases, besides the risk to patients, the cost of providing these treatments
can be very high. For example, in the state of São Paulo, R$40 million (around
US$19 million)17 was spent to comply with judicial decisions ordering drugs for
cancer from 2005 to 2006. However, 17 per cent of this amount was spent on drugs
without scientific evidence that they could bring any benefit to patients who were
claiming them, either because the drug was not registered with the ANVISA or
because it was not recommended for the claimants’ condition according to the exist-
ing clinical guidelines and protocols (off-protocol use).18 Similar data was found by
Vieira and Zucchi:19 three out of 10 kinds of drugs for cancer provided by the city of
São Paulo in compliance with judicial orders were not registered with the ANVISA
and most of the rest lacked evidence of their effectiveness under the claimants’ cir-
cumstances. It is also important to highlight that drugs for cancer are extremely ex-
pensive. In the city of São Paulo, just 7.2 per cent of the drugs supplied to comply
with judicial orders were drugs for cancer, although 75 per cent of the total spent to
buy judicially ordered medicines was spent on oncology drugs.20
Apart from drugs, courts have also ordered the provision of other treatments
without robust evidence of safety and effectiveness. In the case STA 223 (2008), the
STF decided that the health system should pay for surgery that could only be per-
formed by an American surgeon, who had to be brought to Brazil with all expenses
(flights, hotel and a US$150,000 treatment) paid for by the State. The surgery was
14 Machado et al., ‘Judicialization of access to medicines in Minas Gerais state, South eastern Brazil’ (2011)
45 Revista de Saúde Pública 590; Wang et al., supra n 13; Figueiredo, supra n 6; Messeder et al.,
‘Mandados judiciais como ferramentas para garantia do acesso a medicamentos no setor público: a experi-
ência do Estado do Rio de Janeiro, Brasil’ (2005) 21 Cadernos de Saúde Pública 525.
15 Macedo et al., supra n 9 at 709.
16 See Machado et al., supra n 14; Pereira et al., supra n 7; Pepe et al., supra n 5; Figueiredo, supra n 6;
Chieffi and Barata, supra n 9; Vieira and Zucchi, supra n 10.
17 The values in US dollars in this article were calculated using the average exchange rate in the last month
of the respective year.
18 Lopes et al., ‘Rational Use of Anticancer Drugs and Patient Lawsuits in the State of São Paulo, South
Eastern Brazil’ (2010) 44 Revista de Saúde Pública 620.
19 Vieira and Zucchi, supra n 10.
20 Ibid.
not approved by the American FDA and was never evaluated by the ANVISA. In RE
368546 (2011), the STF decided that six people had the right to receive treatment
for pigment rethinosis in Cuba, with all expenses covered by the State, in spite of the
medical consensus affirming that this treatment does not work.21 In a recent
decision, the Ministry of Health was ordered to pay for an experimental US$870,000
surgery in the United States and also for all expenses related to the patient and her
parents’ transportation and living costs abroad.22
The safety and effectiveness of treatments should be the first things to be con-
sidered when designing healthcare policies. However, there is another element that
cannot be neglected: cost-effectiveness. Even if it is proved that a new treatment is

safe and effective, it is important to assess whether it is more effective than the exist-
ing treatments and, if it is, whether its costs compensate the gains in health it pro-
duces. Ideally, patients would be cared for with the best treatments available, but the
scarcity of resources is a ubiquitous reality and therefore cost-effectiveness should be
taken into consideration by health systems in deciding what can be provided to
patients.
Machado et al. found that there were alternative treatments available in the SUS
for 73 per cent of the drugs not included in pharmaceutical policy that were provided
via judicial order.23 In Vieira and Zucchi’s sample this rate was 80 per cent.24 In these
cases, patients were demanding modern (and more expensive) treatments that are
allegedly better than the drugs available in the SUS.
The case of the analogous insulin, the most litigated treatment in the state of São
Paulo and the cities of São Paulo and Rio de Janeiro,25 is an interesting example.
The SUS provides human insulin to patients, but litigants want to have free access to
the so-called analogous insulin, the use of which is more convenient to patients. The
Brazilian Ministry of Health has steadily refused to provide the analogous insulin on
the basis that there is no robust scientific evidence that it is more effective than
human insulin for the control of diabetes.26 The cost of analogous insulin is also a
relevant reason for the SUS not providing what some patients and doctors prefer.
The National Council for Incorporation of Technologies in the SUS (see section
3.B) has recently assessed two types of analogous insulin and did not recommend
their incorporation in the SUS. It did not find strong evidence that they are more
21 The Brazilian Ophthalmology Association, the institution that represents ophthalmologists in the country,
participated in the judicial procedure and confirmed before the STF that the treatment is ineffective.
22 Ferraz and Wang, ‘As Duas Portas do SUS’ (2014) Folha De São Paulo at A3vol.
23 Machado et al., supra n 14.
24 Vieira and Zucchi, supra n 10.
25 See da Silva and Terrazas, ‘Claiming the Right to Health in Brazilian Courts: The Exclusion of the
Already Excluded’ (2011) 36 Law and Social Inquiry 82; Wang et al., Judiciário e fornecimento de insulinas
análogas pelo sistema público de saúde: direitos, ciência e polı́ticas publicas, Projeto Casoteca Direito GV
(2011), available at: http://direitosp.fgv.br/casoteca/judiciario-fornecimento-de-insulinas-analogas-pelo-
sistema-publico-de-saude-direitos-cienci [last accessed 3 August 2015]; Figueiredo, supra n 6; Wang and
Ferraz, ‘Reaching Out to the Needy? Access to Justice and Public Attorneys’ Role in Right to Health
Litigation in the City of São Paulo’ (2013) 18 SUR International Journal on Human Rights 159.
26 Ministry of Health, Relação Nacional de Medicamentos Essenciais. 6a edição. Série B: textos básicos de
saúde (Brasilia, 2008). See also Siebenhofer et al., ‘Short Acting Insulin Analogues Versus Regular
Human Insulin in Patients with Diabetes Mellitus (Review)’ (2009) 1 The Cochrane Library, available at:
www.thecochranelibrary.com [last accessed 18 August 2015].
effective than the human insulin and it would cost six times more for the SUS to
provide the analogous instead of the human insulin, an incremental cost of R$13.5
billion (around US$5.4 billion) over five years.27 For most judges, however, if the
patient has a prescription for the analogous insulin, then her right to health will
trump priority-setting considerations.28
Lastly, Norheim and Gloppen developed a methodology using Quality Adjusted
Life Years (QALY) and the country Gross Domestic Produce (GDP) per capita to
establish thresholds to grade health treatments according to levels of priority for the
population. Applying this methodology to a sample of litigated drugs in Brazil, the
authors concluded that most of them should be classified as having a low priority,

since they provide small or marginal health benefits at a high opportunity cost for
the healthcare system.29
B. How Courts Judge

Duran et al. analysed 144 cases demanding HIV drugs that were not incorporated in
SUS’s policy for HIV and found that the State of São Paulo Court of Appeal judged
85 per cent of them in favour of the patient.30 Moreover, in the lower courts, the
rate of success is absolute: all cases were judged in favour of the patient. The court’s
predominant view is that the right to health is an individual’s right and only in a
small number of cases did it consider that economic and policy reasons can be used
to justify the non-provision of a drug to a patient.
Marques and Dallari analysed cases judged by lower courts in the state of São
Paulo and found that patients won in more than 90 per cent of the cases.31
Additionally, in more than 80 per cent of the decisions, the judge affirmed that the
patient’s right to comprehensive healthcare should be guaranteed and could not be
restricted by budgetary or policy considerations. Grinover et al. found that, from
2010 to 2012, the State of São Paulo Court of Appeal, the State of Minas Gerais
Court of Appeal and the third Circuit Federal Court of Appeal have judged over
90 per cent of the cases in favour of the litigant patient.32.
Pepe et al.33 and Santa’Anna34 found that patients won 100 per cent of the cases in
the lower courts in the state of Rio de Janeiro. Santa’Anna also found that patients won
all the cases in the Court of Appeal.35 In the sample analysed by Ventura et al., all the
27 Ministry of Health, Insulinas Análogas de Longa Duração – Relatório de Recomendação da Comissão

Nacional de Incorporação de Tecnologias no SUS – CONITEC – 103 (Brası́lia, 2014).
28 Wang et al., supra n 25.
29 Norheim and Gloppen, ‘Litigating for Medicines: How Can We Assess Impact on Health Outcomes’ in
Yamin and Gloppen, supra n 1 at 313.
30 Duran et al. ‘O Judiciário e as polı́ticas públicas de saúde no Brasil: o caso AIDS’. Prêmio Ipea 40 Anos:
Monografias Premiadas (2004).
31 Silvia Badim Marques and Sueli Gandolfi Dallari, ‘Safeguarding of the Social Right to Pharmaceutical
Assistance in the State of São Paulo, Brazil’ (2007) 41 Revista de Saúde Pública 101.
32 Grinover et al., Avaliação da prestação jurisdicional coletiva e individual a partir da judicialização da saúde,
CEBEPEJ/DIREITOGV, 2014, available at: http://cpja.fgv.br/sites/cpja.fgv.br/files/relatorio_final_
judializacao_da_saude.pdf [last accessed 18 August 2015].
33 Pepe et al., supra n 5.
34 Sant’Anna, supra n 11.
35 Ibid.
claimants in the city of Rio de Janeiro had injunctions decided in their favour.36 In the
state of Rio Grande do Sul, in 93 per cent of the cases the claimant had an injunction
granted by the court, in 96 per cent of them the final ruling in the lower courts was
completely or partially in favour of patients, and 89 per cent of the cases that reached
the State of Rio Grande do Sul Court of Appeal were decided in favour of patients.37
Wang et al. analysed how 12 courts (the Supreme Federal Court, the Superior
Court of Justice, five State Courts of Appeal and five Federal Courts of Appeal)
judged cases in which analogous insulin was claimed.38 Analysis of 502 cases found
that patients won in 88 per cent of them. Furthermore, in five courts, the rate of
success was 100 per cent and in two of them, it was more than 95 per cent. The case

of the analogous insulin is especially interesting because, as already discussed, there
is scientific uncertainty about the benefits of its use as a substitute for regular insulin.
This was an argument used by health authorities in courts to justify the non-
provision of the analogous insulin, yet in 84 per cent of the cases courts considered
that it was for the patient’s doctor, rather than the health authorities, to decide which
treatment should be given to them. Hence, according to courts, as long as patients
have a prescription affirming that the analogous insulin is necessary, the public health
system should provide it without further enquiry as to the quality of the evidence on
which the physician’s opinion is based.
Similar findings regarding the kind of evidence used by courts was found by Ventura
et al:39 in 97 per cent of the cases the judicial decision was based solely on the medical
information provided by the claimants’ doctors and no further evidence regarding the
quality of the treatment, the need of the patient or the alternative treatments was required.
The problem with this deferential attitude towards a doctor’s opinion is that phys-
icians do not always base their prescription on the best scientific evidence.40 This may
happen, for instance, because of the difficulty for practitioners to keep up-to-date with
all the new scientific information; the biases in the dissemination of scientific research;
the marketing strategies of pharmaceutical companies; and conflicts of interest.41
Should this judicial reasoning be maintained, courts will become an obstacle for
evidence-based medicine in Brazil.
In sum, applicants’ high rate of success can be explained by the prevalent interpret-
ation of the right to health as an individual trump against priority-setting decisions,
coupled with the lack of stringent scientific evidence requirements for the provision of
treatment via court proceedings. This predominant approach to right to health litiga-
tion in Brazilian courts is along the lines of the case law of the STF, the highest Court
of Appeal and the Constitutional Court.
In the first case decided by the STF,42 the claimant demanded the SUS pay for an
experimental treatment only available in the United States (the costs included
36 Ventura et al., ‘Judicialização da saúde, acesso à justiça e a efetividade do direito à saúde’ (2010) 20
Revista de Saúde Coletiva 77.
37 Biehl et al., ‘Judicialisation of the Right to Health in Brazil’ (2010) 373 The Lancet 2182.
39 Ventura et al., supra n 36.
40 Moon et al., ‘Getting Better Value from the NHS Drug Budget’ (2010) 341 British Medical Journal 6449.
41 See, for instance, Goldacre, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (2012).
42 Pet 1246 Supreme Federal Court (1997).
transportation, treatment and foreign living expenses). In this decision, the STF
made a statement that has been constantly quoted in subsequent decisions by other
courts and by the STF itself:
[In choosing] between protecting the inviolability of the right to life, an

inalienable Constitutional fundamental right, and a financial and secondary
interest of the State, I believe — once this dilemma is established — ethical
and legal reasons leave the judge with only one possible option: unwavering
respect for life.

There were some cases in which the STF departed from the view that the right to
health is absolute and recognized that the public health system cannot focus exclu-
sively on the specific needs of the applicant patient and should consider the allocative
impact of its decisions.43 However, after almost 20 years going back and forth trying
to establish criteria for the judicial review of rationing decisions, and in spite of the
public hearing held by the court (see section 3.A.i), the interpretation that the right
to health entitles patients to receive any health treatment they need, because people’s
health and life trump ‘financial and secondary interests of the State’, is still an
approach that is prevalent within Brazil’s highest court.
The STF is still reluctant to accept that the scarcity of resources and the lack
of scientific evidence are acceptable reasons to deny healthcare. It is also worth
mentioning again and quoting the case RE 368546,44 in which the government was
obliged to provide treatment for pigment rethinosis in Cuba despite scientific
evidence that it is ineffective. One of the Justices (Marco Aurelio) undermined the
extensive evidence against the effectiveness of the treatment and the objections
against its high costs for the public health budget by affirming:
I cannot accept that the lack of economic resources can be articulated to

deny health care to a citizen . . . according to what I read in the media, the
successful treatment for this disease is indeed in Cuba.
Similarly, another Justice (Luiz Fux) reasoned:
I am very determined when it comes to hope. I never believed in the version

that the pigment rethinosis could not be cured in Cuba. Quite the opposite, I
think that they [Cubans] are specialists in this area and there should be hope
concerning the cure.
In the most recent case,45 the STF decided that the public health system should pro-
vide a high cost treatment (US$409,500 per year) despite the fact that the treatment
has never been incorporated in the SUS nor has it been registered with the ANVISA.
43 See Wang, ‘Courts and Health Care Rationing: The Case of the Brazilian Federal Supreme Court’ (2012)
8 Health Economics, Policy and Law 75.
44 RE 368546 Supreme Federal Court (2011).
45 STA 761 Supreme Federal Court (2014).
(i) Collective claims

Even though right to health litigation in Brazil is mainly driven by individual
lawsuits,46 there are also cases of collective claims, normally demanding access to
drugs not regularly provided by the SUS to a group of identified patients or to all
patients in a given jurisdiction (which can be a city, a state, the Federal District or
the Federal Government).47 The former are very similar to individual lawsuits and
the only difference is that there is more than one claimant. Courts decide these cases
in the same way that they decide individual claims. The latter lawsuits, on the other
hand, raise different issues because they are more structural in the sense that they are
not a dispute between two parties and may cause far-reaching reforms that aim at

affecting a multiplicity of parties.48
Interestingly, the same courts that show almost no restraint in reviewing rationing
decisions in individual cases are more reluctant to decide in favour of claimants
when the claim is collective and structural.49 As already shown, in individual cases
courts tend to ignore the impact of their decisions on the public health budget and
on the other users of the SUS; the need to set priorities in health expenditure;
and the capacity and legitimacy of courts to assess scientific evidence and to make
allocative decisions. Conversely, in collective claims with potentially structural effects
all these elements are considered by courts to justify their deference to a rationing
decision made by health authorities.50
As shown by Wang et al.,51 some of the same courts that grant access to
analogous insulin to practically any patient who goes individually to claim it turn
down claims for the incorporation of this insulin for regular provision by the SUS.
Courts tend to argue that resources are scarce and judges are not in the best position
to second-guess the decisions made by health authorities.
Two decisions by the STF make clear the preference for adjudicating the right to
health individually rather than collectively: SL 256 (2010) and STA 424 (2010). The
latter involved a request for universal provision of three drugs (not incorporated in
the SUS) for treating microcephalia. The former was a complaint to oblige the health
system to pay for the transport, food and accommodation costs of any patient in the
city of Araguaı́na who needed to receive treatment in another city. The STF rejected
both claims, arguing that the judiciary should not require health authorities to fulfill
duties that are overly ‘general’, because this may unduly affect the public budget and
would ‘impair the regular functioning of the health system administration, reduce
efficiency in patient care and limit the available resources’.
Nonetheless, both decisions emphasized that the drugs in the one case, and the
transport, food and accommodation in the other, must be provided if the need is
proved individually. In the case SL 256 (2010), apart from the general demand for
the SUS to pay for the transport, food and accommodation to all citizens of
46 According to the research carried out by Grinover et al., supra n 32, collective claims represent less than
one per cent of right to health litigation cases in Brazil.
47 There are also lawsuits requiring the improvement of health facilities, see Wang and Ferraz, supra n 25.
48 Fiss, ‘The Social and Political Foundations of Adjudication’ (1982) 6 Law and Human Behavior 121 at 123.
49 See Wang et al., supra n 25; Wang and Ferraz, supra n 25; Hoffman and Bentes, supra n 1 at 224–5.
50 Wang et al., ibid; Hoffman and Bentes, supra n 1 at 224–5.
51 Wang et al., ibid.
Araguaı́na, there was also a request for the provision of these services to some
particular individuals, which was granted by the court.
The fact that individual and collective cases tend to be decided differently can be
explained by the fact that in individual lawsuits there is the impression that an indi-
vidual decision has no potential to cause much impact, whereas a collective claim can
have large-scale policy implications.52 This impression is false because the aggregate
effect of individual lawsuits can be enormous, as will be shown in the next section.
C. The Budgetary Impact

Right to health litigation has been growing steadily in Brazil in recent years, as well

as the economic impact of the decisions on the public health budget. At the federal
level, to comply with judicial decisions ordering the supply of health treatments the
Ministry of Health expenditure increased from R$2.5 million in 2005 to R$244
million (around US$135 million) in 2011: a solid 9,660 per cent increase in six years.
The aggregate expenditure by the Federal Government from 2003 to 2011 was
around R$588 million (around US$326 million), 85 per cent of which was spent in
2009–2011.53 The impact of a few very expensive drugs is also noteworthy: in 2011,
the amount spent on the 20 most expensive drugs that were claimed by 632 patients
(0.05 per cent of the total litigants in that year), represented 78 per cent of the total
spent by the Ministry of Health to purchase drugs in compliance with judicial orders.
At sub-federal level—states and municipalities—the sheer scale of the impact of
right to health litigation is also impressive. In the state of Minas Gerais, the amount
spent on complying with health litigation decisions increased from R$8.5 million in
2002 to R$42.5 million in 2008 and R$205 million (US$85 million) in 2013. This
represented three per cent of the state’s healthcare budget for that year.54 In the state
of Rio Grande do Sul, the number of lawsuits increased from 1,126 in 2002 to
17,025 in 2009 (an increase of 1,412 per cent).55 The amount spent by the state of
Rio Grande do Sul on health treatments ordered by courts in 2008 represented 22
per cent of the total amount spent by the state on pharmaceutical drugs and four per
cent of the state’s projected health budget for that year.56
The state of São Paulo spent R$400 million in 2008, R$512.5 million in 2009,
and around R$700 million (US$411 million) in 2010, an amount equivalent to five
per cent of the state budget for healthcare that year.57 The number of drugs supplied
52 See Landau, supra n 2.

53 The figures were calculated by using the data provided by The Ministry of Health and The Federal
Attorney General’s Office, supra n 12.
54 Machado et al., supra n 14; data provided by the state of Minas Secretary of Health to the author on
31 August 2014; and public budget information by the Legislative Assembly of the State of Minas Gerais,
available at: www.politicaspublicas.almg.gov.br [last accessed 18 August 2015].
55 Biehl et al., supra n 37.
56 Ibid.
57 Naffah Filho et al., ‘S-Codes: A New System of Information on Lawsuits of the State Department of
Health of São Paulo (2010) 7 Boletim Epidemiológico Paulista 18; Ministry of Health and The Federal
Attorney General’s Office, supra n 12; Segatto, ‘O paciente de R$800 mil’ (2012), Epoca, available at:
www.revistaepoca.globo.com/tempo/noticia/2012/03/o-paciente-de-r-800-mil.html [last accessed
18 August 2015]. For budget information available at the Finance Secretary of the state of São Paulo, see:
www.fazenda.sp.gov.br [last accessed 18 August 2015].
under a judicial order increased from 799 in 2005 to 14,563 in 2010 and to almost
19,000 in 2013.58 Naffah Filho et al. estimated that, in 2010, the state of São Paulo
spent 4.5 times more in complying with judicial decisions than on hospitalization for
organ transplantation. The total amount was also equivalent to 90 per cent of what
was spent on the 123 million clinical diagnoses made by the public health system in
the whole state of São Paulo; 28 per cent more than what was spent on dialysis; and
29 per cent more than what was spent on chemotherapy and radiotherapy.59
In the state of Santa Catarina, the amount spent increased from R$38,362 in 2001
to over R$6.5 million in 200460 and R$93 million (US$54 million) in 2010.61
Another interesting finding in the state of Santa Catarina is that the drugs claimed

through courts are getting more and more expensive. In 2001, the average cost per
drug was R$2,019 and increased to R$8,157 (US$3,000) in 2004. That means that
not only are more drugs being litigated for, but also that more expensive drugs are
being claimed through litigation.62
At municipal level, the increase in litigation and its costs are also relevant. In the city
of Florianopolis, there was a 3,944 per cent increase in expenditure on drugs ordered
by judicial decision: from R$3,398 in 2003 to R$137,429 (US$65,400) in 2006.63 In
the city of São Paulo it was estimated that the amount spent on complying with right to
health litigation decisions in 2011 was around R$8.9 million (US$5 million). This
amount represented 10 per cent of the city’s budget for the pharmaceutical policy in
that year.64 In cities with smaller budgets, the impact of right to health litigation can be
even more dramatic. For example, in Buritana, a small city of 15,000 inhabitants, more
than 50 per cent of the budget for drugs was spent on providing treatment ordered by
courts and one single patient won in court the right to receive a treatment that will cost
the municipality 16 per cent of its entire budget for drugs.65
In 2009, a survey sent by email and posted to all the 5,564 Brazilian cities tried to
measure the impact of health litigation at municipal level. Out of the total surveyed,
24 per cent (1,276) of the cities answered. The result was that more than 50 per
cent of the responsive cities affirmed that they were facing an increase in right to
health litigation cases. One-third of the respondents affirmed that health litigation
was an ‘important problem’ for them. Respondents were also asked to provide infor-
mation concerning the number of lawsuits they had to respond to and the amount of
money that was spent on complying with those cases decided in favour of patients.
The result was that the number of lawsuits and the amount spent on complying with
decisions in the first semester of 2009 had outpaced the total amount in 2007 and
was close to the total in 2008.66
58 Naffah Filho et al., ibid. (data provided to the author by the state of São Paulo Attorney’s Office).
59 Ibid. at 28.
60 Pereira et al., supra n 7.
61 National Council of Justice, SP, RS e RJ são estados que mais concentram processos na área de Saúde,
available at: www.cnj.jus.br/noticias/cnj/57537-sp-rs-e-rj-sao-estados-que-mais-concentram-processos-na-
area-de-saude [last accessed 18 August 2015].
62 Pereira et al., supra n 7.
63 Leite et al., supra n 8.
65 Segatto, supra n 57.
66 Ferraz, ‘Brazil’, supra n 1.
In conclusion, the resources spent by the public health system on complying with
judicial decisions are already very significant and are consuming an increasingly large
amount of the public health budget. Given that the public health budget’s growth
cannot keep up with the growth in litigation, courts are having a major impact in
reallocating public healthcare resources in Brazil by compelling the provision of treat-
ments without proper appraisal of their safety or effectiveness. Courts show almost
complete disregard for policy considerations such as cost-effectiveness, fairness,
budgetary capacity of the state and the health needs of the population. Moreover,
given that litigation is mainly driven by individual claims, courts are forcing an
increase in expenditure on goods that can be individually consumed (for example,

drugs) rather than on common goods and public services that benefit whole popula-
tions (for example, preventative health programmes).
Litigation also creates a two-tier public health system—one upper-tier for those
who can litigate and have access to any treatment irrespective of cost, and the other
for the rest of the population who have access to more limited care. Healthcare
resources are distributed according to a morally arbitrary principle, the capacity to
litigate, which is certainly not evenly distributed in society.67 It can be expected,
however, that right to health litigation will progressively become more accessible as
people are better informed, there is more public investment in legal aid and pharma-
ceutical companies have incentives to encourage litigation.68 This can make right to
health litigation apparently less unfair, but the fact that more people litigate and thus
go up to the upper-tier created by courts means that litigation will affect more
severely the rest of the population in the tier below.
3. TH E I N ST IT UT IO NA L RE S P ON SE S
The impact of courts on healthcare policies has become too big to be ignored. This
section will discuss the three most overarching responses to control its negative
impact on the public health system. Two come from the highest institutions of the
judicial branch and the third is the Federal Law 12.401/11. All these proposals have
in common the fact that they try to establish a sphere of judicial restraint in which
courts should defer to the decisions made by health authorities. Thus, they try to
oppose the Brazilian courts’ prevailing interpretation that there is an individual right
to receive healthcare that cannot be restricted by health authoritieś priority setting
decisions or the lack of robust scientific evidence. However, they disagree on what
courts should do when there are claims for drugs not incorporated in the SUS
67 There is data indicating that right to health litigation creates an anti-poor bias because claimants from
higher socio-economic groups tend to be over-represented in these cases: see da Silva and Terrazas, supra
n 25; Ferraz, ‘Harming’, supra n1; Wang and Ferraz, supra n 25. See, however, Biehl et al., ‘Between the
Court and the Clinic: Lawsuits for Medicines and the Right to Health in Brazil’ (2012) 14 Health and
Human Rights 36; Medeiros et al., ‘The Thesis of Judicialization of Health Care by the Elites: Medication
for Mucopolysaccharidosis’ (2013) 18 Ciência & Saúde Coletiva 1089.
68 The evidence on pharmaceutical companies encouraging and funding right to health litigation by
connecting patients, doctors and lawyers is abundant: see Chieffi and Barata, ‘Ações judiciais: estratégia
da indústria farmacêutica para introdução de novos medicamentos’ (2010) 44 Rev Saúde Pública 421;
Naffah Filho et al, supra n 57; Medeiros et al., supra n 67; Wang and Ferraz, ‘Pharmaceutical Companies
vs. the State: Who Is Responsible for Post-Trial Provision of Drugs in Brazil?’ (2012) 40 The Journal of
Law, Medicine & Ethics 188.
pharmaceutical policy; and this is a central issue since, as discussed in section 2, these
claims are the main drivers of right to health litigation in Brazil.
A. Self-Restraint and Institutional Capacity: Responses

from the Judicial Branch
Concerns about courts’ lack of institutional capacity and the limits of the adjudicative
process are some of the most common criticisms of courts deciding on the provision
of welfare benefits via social rights adjudication. Judges, according to this argument,
who are trained in law and legal process, who lack the knowledge, expertise, qualifica-
tions or experience to decide on multifaceted issues of policies, especially those

involving the allocation of scarce resources. Moreover, the adversarial model of adju-
dication tends to reduce polycentric problems which ‘involve many affected parties
and a somewhat fluid state of affairs’ to bilateral disputes and is poorly prepared to
gather and analyse complex social data.69 Courts will know a lot about a case, but lit-
tle about its milieu and thus will not be able to see the trade-offs in the competition
for budgetary resources or political follow throughs.70
On the other hand, those who advocate for a more active role of courts in social
rights adjudication affirm that courts, when protecting civil and political rights, also
deal with complex issues that may be very similar to those raised by social rights ad-
judication. Thus, the judicial protection of social rights creates challenges for courts
that are not so different from those they commonly face. Furthermore, judges can be
provided with relevant information by the parties, their lawyers, witnesses and court-
appointed individual experts and bodies. Some individual judges can also specialize
in social rights adjudication through experience and legal education, in the same way
that they specialize in other fields of law. Finally, the judicial process can be made
more participatory—open to amici curiae and public hearing—to enable courts to
deal with the complex issues brought before them in cases involving social rights.71
The response to right to health litigation advanced by the STF and the CNJ can
be contextualized in this debate about the capacity of courts and of the adjudicative
process to decide properly on the provision of welfare policies. Both institutions rec-
ognize that courts have institutional limitations and therefore can only be secondary
decision-makers on the issue of healthcare provision. However, at the same time,
they try to overcome these limitations to give to courts a prominent role in the judi-
cial review of rationing decisions on a case-by-case basis.
The response advanced by the STF and the CNJ can be better understood as
complementary parts of the same policy engaged with right to health litigation. This
is not surprising since there is a strong connection between both institutions. The
CNJ is a formally autonomous institution, but it is expected that the STF, especially
its president, will have a significant influence on the CNJ. The presidency of the
CNJ, which has a great deal of responsibility in setting the institution’s agenda, is
69 Fuller, ‘The Forms and Limits of Adjudication’ (1978) 92 Harvard Law Review 353 at 394.
70 Horowitz, ‘Umpire or Empire?’ (1982) 6 Law and Human Behaviour 129.
71 See, for instance, Nolan et al., ‘The Justiciability of Social and Economic Rights: An Updated Appraisal’
(Center for Human Rights and Global Justice Working Paper, 2007) at 14–15; Mantouvalou, ‘In Support
of Legislation’ in Gearty and Mantouvalou (eds), Debating Social Rights (2011); Gargarella, ‘Dialogic
Justice in the Enforcement of Social Rights: Some Initial Arguments’ in Yamin and Gloppen, supra n 1.
chaired by the Chief Justice of the STF. Moreover, the STF has the prerogative to
appoint the other two members of the CNJ. The affinity between the recommenda-
tions of the CNJ and the decisions of the STF will be made clearer in the following
subsections.
(i) The Supreme Federal Court: public hearing and the establishment of a test
The STF is the last court of appeal in the Brazilian judiciary and the constitutional
court. It held a public hearing in 2009 with over 50 experts (including healthcare
professionals, public authorities, legal scholars and civil society representatives),
heard over a period of six days, to supply the STF with ‘technical, scientific, adminis-

trative, political and economic’ information related to the right to health litigation
phenomenon.72
The public hearing was motivated by the acknowledgement that litigation has a
significant impact on the public health system and that the court needed support
from different specialists and stakeholders to make better decisions.73 Chief Justice
Gilmar Mendes (as he then was) held the public hearing and declared in his opening
speech that ‘either the idea that courts should have no role in healthcare issues or
that there is a right to any health treatment is untenable’ and that a balanced view
should be found, taking into consideration ‘all the judicial decisions’ implications
without compromising . . . the right to health’.74 Lastly, he affirmed that he expected
the ‘public hearing would result not only in technical information conducive to assist-
ing in the court’s analysis of the cases, but also in support for a broader and pluralist
debate for the improvement of health policies’.75
Initiatives like public hearings can be seen as a device to defend more activist
courts against critics concerning their institutional capacity, but also as a tool for
helping them to implement their potential for enhancing democracy and participa-
tion. Accordingly, there is an expectation that courts can be a forum to ensure that
norms are created and applied through a ‘collective and inclusive discussion’.76 The
public hearing held by the STF was praised by analysts as a good example of what
courts should do in regard to the protection of the right to health.77
It is not within the scope of this article to discuss exhaustively whether courts can
create collective and inclusive discussion via public hearings. Nonetheless, it is import-
ant to mention that the potential benefits of deliberation promoted via public hearings
have to be weighed against the possibility that judges ‘may cherry-pick from available
studies to support a foregone conclusion’, especially when there is a large amount of
conflicting data and the interpretation of complex facts is required;78 and that the
72 Mendes, ‘Opening of the Public Hearing n. 4 at the Supreme Federal Court’, Supreme Federal Court,
2009, available at: www.stf.jus.br/arquivo/cms/processoAudienciaPublicaSaude/anexo/Abertura_da_
Audiencia_Publica__MGM.pdf [last accessed 18 August 2015].
73 Ibid.
74 Ibid. at 9.
75 Ibid. at 10.
76 Gargarella, supra n 71 at 237–8. See also Nolan, Children’s Socio-Economic Rights, Democracy and the
Courts (2011) at 195.
77 See Gargarella, ibid. at 237; Nolan, ibid. at 78.
78 King, Judging Social Rights (2012) at 242.
outcome of the dispute (the judicial decision) may not reflect the deliberation about it
given that judges cannot be punished for not grounding their reasons on the
deliberation.79
A concrete outcome of the public hearing discussed here was the establishment of
a test to define those duties citizens can immediately demand from the SUS. This
test was established in several cases judged by the STF after the public hearing was
held and, according to the STF, it was based on the conclusions drawn from the
information presented by the speakers at this public hearing.80
It should first be noted that there was an important factual mistake made by the
STF when establishing this test. The STF affirmed that most of the litigation is driven

by claims for drugs already included in the pharmaceutical policy, a statement that is
falsified by the existing evidence (see section 2.A). Moreover, in these decisions there
was explicit reference to only a few of the contributions made to the public hearing
and the test established by the court draws heavily on the academic work of one
participant.81 Lastly, in the most recent decisions the STF has simply ignored the dis-
cussions that took place during the public hearing and the test established thereafter.
It again decided as if the right to health were an individual ‘trump’, neglecting policy
considerations and the need for robust scientific evidence (see section 2.B). These ob-
servations about this public hearing vindicate concerns about the court ‘cherry-picking’
from available data, not grounding its decisions on the deliberation and, therefore,
using a participative procedure only to legitimize a foregone conclusion.
With regard to its substantial aspect, the test established by the STF sets some crite-
ria to distinguish those cases when the court should defer to the allocative decisions
made by health authorities and those when it should oblige the SUS to offer a treat-
ment allegedly needed by the patient but denied by the government (see Figure 1).
The first criterion establishes that the government cannot deny citizens treat-
ments already incorporated in the SUS, namely, those on the official lists or recom-
mended by clinical protocols and guidelines. If the treatment being claimed has not
been incorporated, then there is a duty to provide it only where it has been regis-
tered with the National Health Surveillance Agency (ANVISA); there is no adequate
alternative treatment provided by the SUS; and the treatment has been available in
the market for a long time.82
The test established by the STF aimed at creating a sphere of judicial self-restraint,
but also one in which courts could legitimately intervene. Even though this test would
rule out the provision of treatments without evidence of effectiveness and safety, or
those that are not superior to the existing alternatives, it still ignores policy consider-
ations and allows the adjudication of the right to health as an individual trump.
The STF has not clarified how to determine whether the alternative treatment
offered by the SUS is adequate, especially when claimants (together with their
79 Tushnet, Weak Courts, Strong Rights: Judicial Review and Social Welfare Rights in Comparative
Constitutional Law (2008) at 94.
80 See Wang, supra n 43 at 81.
81 A very similar test was suggested by Sarlet and Figueredo. ‘Reserva do possı́vel, mı́nimo existencial e
direito à saúde: algumas aproximações’ in Sarlet and Timm (eds), Direitos Fundamentais: Orçamento e
Reserva do Possı́vel (2008).
82 For a longer discussion of this test, see Wang, supra n 43.

Figure 1. The STF’s test to determine a claimant’s right to receive a health treatment.
lawyers and doctors) and health authorities disagree. This brings us back to the prob-
lem of courts’ institutional capacity and may help to explain the purpose of the rec-
ommendations of the CNJ to build courts’ institutional capacity, as will be discussed
in the next subsection.
Moreover, it is not clear either if the alternative offered by the SUS has to be only
effective for the patient’s health problem or at least as effective as the claimed treat-
ment. A new treatment may be marginally better, but at a much higher cost. The
decision about whether a new treatment that is more effective, but more expensive,
should be provided in the place of another that is less effective, but cheaper, is one of
the biggest challenges for health systems around the world all trying to maximize
health benefits with limited resources.83
83 See Schmidt and Kreis, ‘Lessons from Abroad’ (2009) 39 Hastings Center Report 20; Sorenson and
Chalkidou, ‘Reflections on the Evolution of Health Technology Assessment in Europe’ (2012) 7 Health
Economics, Policy and Law 25.
Lastly, the criterion that allows courts to order the supply of a treatment if it has
been available in the market for a long time seems to ignore the cost-effectiveness
analysis and policy considerations in deciding the provision of healthcare.84 The fact
that a drug is available for private purchase means only that it is efficient and safe
(that is, registered with the ANVISA), but tells nothing about its cost-effectiveness,
level of priority and affordability for the SUS.
In sum, the public hearing has not prevented the STF from underestimating the
complexity of healthcare policies and overestimating the capacity of courts to make
allocative decisions in healthcare. The same can be said about the response of the
CNJ, as will be seen in the following section.

(ii) The CNJ: building courts’ institutional capacity
The CNJ is part of the Brazilian judicial branch, but has no judicial power and cannot
review judicial decisions. It is an agency responsible for regulating the administrative
and financial activities of the judiciary and for the enforcement of judges’ professional
duties. It can issue resolutions and recommendations for courts to improve their
functioning in terms of strategic planning and administration.
Following the public hearing held by the STF, the CNJ issued Recommendation
31/2010 proposing some policies regarding right to health litigation which reinforces
and complements what was already put forward by the STF. For the reasons already
presented, the affinity between the CNJ and the STF was to be expected. Justice
Gilmar Mendes, the President of the CNJ at the time when Recommendation
31/2010 was issued, was also the Chief Justice of the STF who organized the public
hearing and who wrote the leading opinion of the judgment in which the test
discussed in the subsection above was established.
Recommendation 31/2010 ‘recommends to courts the implementation of meas-
ures aiming at supporting judges and other legal professionals in order to assure bet-
ter solution for the judicial claims related to healthcare’. It affirmed that the main
problems caused by right to health litigation in Brazil were due to the lack of clinical
information available to judges in the claims for drugs not approved by the ANVISA.
It also stated that the health authority’s managerial capacity, the existing public poli-
cies, the organization of the SUS and the need to guarantee the sustainability and
manageability of the SUS all have to be taken into consideration by courts.
Therefore, the CNJ recommended that Brazilian courts:
a. make technical support from doctors and pharmacists available to assist judges
in assessing the clinical evidence presented by the litigants in healthcare-related
cases;
b. advise judges to analyse the cases based on complete and comprehensive in-
formation; to avoid the provision of drugs not registered with the ANVISA
or experimental drugs; and to consult, whenever it is possible, health
authorities before an interim decision be made;
c. include health law legislation as a subject to be examined in the public
entrance exams for judges; and
84 See Wang, supra n 43.

d. take judges to visit public health units.
It also recommended that the schools responsible for preparing those admitted to
the public entrance exams to become judges85 (i) include health law in their curric-
ula; and (ii) organize seminars with judges, public prosecutors and health authorities
to promote common views on this topic.
The CNJ, apart from establishing a sphere of self-restraint, innovated in trying to
build courts’ institutional capacity to decide on the provision of health treatments.86
Better trained, informed and assisted judges can impact on right to health litigation
in two ways. First, judges with more information will be able to filter out claims

based on poor evidence. Moreover, the more courts know about healthcare policies,
the more wary they should be in reviewing the health authorities’ rationing decisions
because they will be given a broader perspective on the problem than one that is
confined to their decision on a claim for the fulfilment of an individual need. They
will understand, for instance, that the SUS has to make ‘tragic choices’, that there are
opportunity costs, and that rationing is necessary.87.
Secondly, by building courts’ institutional capacity the CNJ tries to create better
conditions for judges to second-guess health authorities’ decisions concerning the
provision of health treatments. It is important to note that Recommendation
31/2010 follows on the public hearing held by the STF and the test established
thereafter. According to this test, courts should order the provision of treatments al-
ready incorporated in the SUS and, when there is evidence that a patient needs a
treatment that is available for private purchase and no effective alternative is offered,
then non-incorporated drugs can be provided via judicial order. Thus, the effort to
provide courts with more knowledge, information and technical support from doc-
tors and pharmacists would allow them to decide if the alternative treatment offered
by the SUS is effective or if the patient really needs the treatment available in the pri-
vate market but not provided by the SUS.
However, it is questionable whether better trained judges assisted by doctors and
pharmacists will be able to acquire and evaluate factual information to make sound
policy decisions. Even if we reduce these decisions to a mere medical/scientific issue,
it would be unrealistic to expect that a group of doctors and pharmacists will have
the necessary diversification of expertise to be able to make a comprehensive scien-
tific assessment of all the treatments that are being litigated for. This task is even
more daunting considering that the main driver of litigation is a wide array of new
medical technologies for various health problems. In countries where health technol-
ogy assessment is taken seriously, this task is carried out by highly specialized and
resourced agencies and scientific committees that are able to gather and assess large
amounts of data applying stringent scientific methods and with a constant dialogue
between stakeholders and experts.
85 In Brazil, lower level courts’ judges are chosen via public entrance exams.
86 Some courts are already implementing some of the recommendations made by the CNJ by creating
‘technical support services’ composed of doctors, nurses, pharmacists and nutritionists to advise judges in
health care litigation cases: see, for instance, Ferreira and da Costa, ‘Technical Advice Centers and
“judicialization of health”: Constitutional or Unconstitutional?’ (2013) 20 Revista da SJRJ 219.
87 See Calabresi and Bobbit, Tragic Choices (1978).
Nonetheless, let us assume, for the sake of the argument, that courts supported
by health professionals can create a system that is able to assess treatments using
sound evidence. That will still not solve all the problems caused by right to health
litigation because the provision of healthcare in a health system is not merely a medi-
cal problem that science can solve. It is a matter of public policy. Doctors and
pharmacists will not be able to consider cost-effectiveness, affordability, opportunity
costs, public health priorities and the preferences of other stakeholders before decid-
ing on the provision of treatment.
Even if we add specialists from other fields to the group of medical experts, it
would still be naı̈ve to expect that their decision would give a ready-made answer to

whether or not a treatment should be provided. Priority setting involves problems of
social fact (for example, how a certain disease affects the population’s health), poly-
centricity (for example, the socio-economic effects of providing a given treatment on
the public health system), politics (for example, the priorities of a community with
regards to healthcare spending) and morality (how to distribute healthcare fairly
given that we cannot give everything to everyone) that cannot be reduced to a tech-
nical decision that can be objectively made by a body of experts attached to courts.
Public policy decisions are inescapably speculative and the impact of which is
hard to predict.88 It is the role of managerial capacity to make and review decisions
according to the consequences and to respond promptly to changing circumstances.
This highlights the importance of the decisions’ procedural legitimacy. Since there is
no unequivocal right decision, it is essential that it be made according to a fair
procedure.89
From this perspective, the expectation that courts make good administrative and
political decisions with better trained judges and expert assistance, but without the
virtues of the public administration (for example, expertise and flexibility) and of a
politically accountable process, seems untenable.90 Moreover, those advantages of
the political and administrative decisions may be undermined by decisions of review-
ing courts, which reverse choices from the political and administrative sphere based
on a different source of evidence.91
To overcome some of these obstacles, one could imagine the CNJ recommending
the creation of a very sophisticated ‘bureaucracy under judicial auspices’ to carry out
health technology assessments and decide on whether a treatment should be pro-
vided in each case.92 Even if we assume that courts have the resources and capacity
to do so, it can be questioned whether this would be more sensible than relying on,
and controlling, the procedure used on the administrative level by health authorities
88 King, supra n 78 at chapter 9.

89 See Daniels, Just Health: Meeting Health Need Fairly (2009).
90 On the importance of expertise and flexibility to decide on welfare policy issues, see King, supra n 78 at
chapters 8 and 9.
91 See Davis, Discretionary Justice: A Preliminary Inquiry (1971) at 118; Vermeule, Law and the Limits of
Reason (2009) at 50.
92 The idea of a ‘bureaucracy under judicial auspices’ to assist courts in cases involving legislative facts was
suggested by Davis, ibid., and has been recently advanced by Yowell, ‘Empirical Research in Rights-Based
Judicial Review of Legislation’ in Huber and Ziegler (eds), Current Problems in the Protection of Human
Rights–Perspectives from Germany and the UK (2012).
who have the structure and expertise to perform this task. The section that follows
will discuss this argument further.
B. The Federal Law 12.401/11: Health Technology Assessment

Federal Law 12.401/2011 was based on two draft bills: the 338/2007, proposed by
Senator Flávio Arns (‘the Arns’ Bill’); and the 219/2007, by Senator Tião Vianna
(‘the Vianna’s Bill’). Both draft bills state that the right to health litigation is the
main justification for their enactment. Nevertheless, they see the problem from
different perspectives and put forward different solutions for it.
In the official justification for his draft bill, Senator Arns affirms that the access to

healthcare cannot be restricted by clinical protocols and guidelines or by official lists
of treatments. According to him, the official lists of treatments are not frequently
updated, restricting patients’ access to new technologies. He also mentioned that the
assessment and incorporation of health technologies is not made through a formal
administrative process, which means that there is no deadline for the assessments
to be concluded, no right to administrative appeal, and no participation from civil
society. He proposed the creation of an institution—composed of government repre-
sentatives and civil society—for assessing health technologies and deciding on their
incorporation in the SUS through a formal administrative procedure. However, the
government would still have to provide treatments not incorporated in the SUS if
the already incorporated treatments are not effective and there is a medical prescrip-
tion declaring that the treatment is necessary to avoid death or serious harm to the
patient.
Vianna’s Bill had a different entry point. In his draft’s justification, Senator Vianna
affirmed that the provision of drugs ordered by courts is forcing the public purchase
of high cost treatments, the effectiveness of which is not always proven. According to
him, this is harmful for the SUS because it gives pharmaceutical companies the
power to lobby patients and doctors to convince them that the treatments they sell
are the best and that patients can access them free of cost through courts. He affirms
that because resources are scarce, priorities have to be set by the SUS to benefit the
largest number of people. Vianna’s Bill also proposed that the SUS should only pro-
vide treatments that are registered with the ANVISA and included in the official lists
of treatments. Thus, Vianna’s Bill would give health authorities the final decision on
the provision of healthcare and would make non-justiciable claims for drugs not
incorporated in the SUS.
In spite of the different proposals and opposing perspectives, both draft bills were
analysed conjointly by the National Congress because, according to the Senate, they
legislate about the same issue. Vianna’s Bill was formally rejected and Arns’ Bill was
approved to become Federal Law 12.401/2011. However, the proposals put forward
by Vianna’s Bill were introduced as amendments to Arns’ Bill. Thus, Federal Law
12.401/2011 is actually an amalgam of both draft bills: it incorporated the rule that
the SUS should only provide treatments that are incorporated in the SUS (as pro-
posed by Vianna’s Bill) and also created an institution responsible for assessing
health technologies through a formal administrative procedure (as proposed by Arns’
Bill).
Federal Law 12.401/11 then established that the provision of treatment in the
SUS can only be made according to the lists, clinical protocols and guidelines issued
by the SUS. It also banned the provision of, or reimbursement for, experimental
treatments and drugs not registered with the ANVISA or not authorized by it. These
rules are, in principle, similar to those established by the STF after the public hearing
and by the CNJ’s recommendation. The main difference is the regime proposed for
treatments not incorporated in the SUS or claimed for off-protocol use, which are
the main drivers of litigation. The CNJ and the STF give courts the power to decide
in these cases. Federal Law 12.401/11 does not allow this exception.
Federal Law 12.401/11 created a new institution—the National Council for

Incorporation of Technologies in the National Health System (CONITEC)—
responsible for carrying out health technology assessments to inform decisions
on the incorporation and exclusion of health technologies by the SUS, as well as the
creation or alteration of clinical protocols and guidelines. CONITEC assesses health
technologies based on the scientific evidence regarding their effectiveness, accuracy
and safety, as well as health economic evaluation by comparing how a new technol-
ogy compares with those already incorporated in terms of cost-effectiveness.
This legislation also established that the incorporation, exclusion or alteration of
treatments has to be made through an administrative procedure that is open to pub-
lic participation by means of public audiences and public consultancy. The appraisal
will be made by independent experts in universities and the assessment has to be
concluded within 180 days starting from the beginning of the administrative process,
and extended by a further 90 days, if necessary. Interested parties also have the right
to administrative appeal against the decisions.
Presidential Decree 7646/2011, which regulates Federal Law 12.401/11, estab-
lished that CONITEC be composed of representatives from many health-related
public institutions, civil society and the Ministry of Health. This Decree also added
that the CONITEC’s reports will be forwarded to the Ministry of Health Secretary
for Science and Technology (SCTIE) for the final decision on the incorporation of a
technology. If the SCTIE decides to incorporate the assessed technology, then the
treatment has to be made available in the SUS within 180 days.
Before the final version of Federal Law 12.401/11 was approved, the President of
the Republic vetoed the article which stated that, if the deadline for the conclusion
of a technology’s assessment was reached and no decision had been issued, then the
technology should have to be available in the SUS until the decision is finally made.
She also vetoed an article stating that the economic impact of a technology is not a
reason to deny its incorporation in the SUS. The justifications given for both vetoes
are very similar. The President asserted the importance of scientific and economic
assessment of a health technology before any decision on its provision is made. She
affirmed that providing non-assessed treatments can bring risk to patients’ health
and is an inadequate way of allocating public resources. Moreover, according to her,
the SUS has to consider the economic impact of a treatment to optimize and ration-
alize the allocation of public funds.
Differently from the responses by the STF and the CNJ, which give courts the
last word on the provision of non-incorporated drugs, Federal Law 12.401/2011
makes it clear that the decision on the provision of healthcare should be in the hands
of health authorities. It created a specialized institution and an administrative process

to decide on the incorporation of new technologies that is expected to be more
inclusive, transparent, accountable, fast and scientifically robust.
According to CONITEC’s first body of directors, the pressure for the incorporation
of new health technologies comes from many groups in society—including patients
and pharmaceutical industries—but they are especially concerned about judicial deci-
sions that compel the provision of drugs based on ‘the right to health as an individual
rather than a collective right’.93 According to them, there is a common opinion among
judges and the general public that if a drug is not provided, it is because the SUS is
badly managed. Within this context, they argue that it is necessary to review the public

policies for health technology assessment by increasing the number of clinical proto-
cols and guidelines, updating them more frequently and making the procedure for in-
corporation of new technologies more transparent and participative.94
After the enactment of Federal Law 12.401/11, the Federal Attorney General’s
Office (AGU), the institution responsible for the legal representation of the federal gov-
ernment, issued several Legal Opinions (Pareceres)95 determining a new strategy for
government lawyers to respond to right to health litigation claims. The Legal Opinions
affirm that, in response to the increase in the number of lawsuits claiming treatments
against the SUS, which are mostly based on weak scientific evidence, it is important for
the government’s lawyers to make reference to the institution and the administrative
procedure created by Federal Law 12.401/11. The strategy is to convince courts that
the SUS’s pharmaceutical policy is based on methodologically stringent scientific inves-
tigation that aims at guaranteeing that the treatments provided are safe, effective and, at
the same time, rationalize and optimize the allocation of financial resources.96
Thus, the history of Federal Law 12.401/2011, the analysis of its first body of direc-
tors, and the Legal Opinions issued by the AGU have all made clear the government’s
strategy to use CONITEC and the new administrative procedure to convince courts
not to review healthcare rationing decisions. The government is working on the as-
sumption that a better administrative procedure for health technologies assessment—
more transparent, participative, accountable, timely and scientifically sophisticated—is
conducive to promoting a more deferential attitude from courts and, consequently,
control right to health litigation and reduce its impact on the public health system.
This does not mean that courts have no role in controlling the decisions made by
health authorities. The AGU’s Legal Opinion 804/2012, for instance, suggests that
instead of reviewing rationing decisions based on its own sources of evidence and
policy analysis, courts can order the assessment of the claimed drug and control the
legality and reasonableness of the procedure carried out by CONITEC. This idea
will be explored further in the Conclusion of this article.
93 Capucho et al., ‘Incorporation of Techonologies in Health in Brazil: A New Model for the Brazilian
Public Health System (Sistema Único de Saúde - SUS)’ (2011) 13 Boletim do Instistuto de Saúde 215.
94 Ibid.
95 AGU’s legal opinions bind all the federal government lawyers.
96 See Legal Opinions 803/2012; 804/2012; 805/2012; 810/2012.
4. CONCLUSION
From the outset right to health litigation in Brazil rules out the possibility of choos-
ing the treatments that will do the most good from a population perspective. It
makes the public health system less efficient because an enormous amount of re-
sources are spent based on poor evidence and in a way that does not maximize the
potential benefits. It also creates unfairness because it generates a two-tier public
health system and distributes resources according to patients’ capacity to litigate.
It would certainly be possible to cherry pick some decisions in which an individual
application of the right to health resulted in a court delivering a right decision, that is,
granting healthcare for a patient who was denied a treatment that was actually safe,

effective, cost-effective, affordable and needed. However, this is not a good argument
to justify courts applying the right to health like most of them do in Brazil. If courts
order the provision of almost any treatment that patients claim, then both right and
wrong decisions will be delivered without criteria to distinguish between them. What
is needed is a procedure that allows a more efficient and fair allocation of resources.
This connects to the argument put forward that the responses from the STF and
the CNJ are incomplete. Their underlying assumption is that courts can deal appro-
priately with allocative decisions in healthcare if they go beyond the limits imposed
by the traditional adjudicative model and try to incorporate attributes that are nor-
mally present in the administrative and legislative arena. As Horowitz observed:
‘[I]nstitutions in competition with each other tend to resemble each other. Each
assumes the characteristics of the other in order to minimize competitive disadvan-
tages’.97 This is perceived as a way to make sure that health authorities do a good job
and, if they do not, to substitute judicial rulings for their decisions.
However, the question is whether, and under what circumstances, they can do a
better job than the primary decision-maker.98 Why should courts try to build their
own institutional capacity and legitimacy to make substantial decisions on the provi-
sion of healthcare when there is an institution created and equipped at the administra-
tive level specifically to make them? If the administrative procedure is good
(transparent, accountable and based on robust evidence and fair principles), then why
replicate it under the auspices of courts? It would be naive to expect that courts can
create a procedure to decide on the provision of healthcare that is better than the one
that can be made at the administrative level. This would also be unnecessarily costly.
If health authorities’ procedure is defective, then it would be better if courts con-
trolled the procedure, occasionally ordering a decision to be remade, rather than ignor-
ing more or less entirely what was decided by health authorities and trying to take its
own decision from scratch. Instead of engaging with scientific issues (for example,
whether treatment A is better than B) or moral, economic and policy reasons (for
example, to balance the needs of a claimant against those of others and the budgetary
capacity of the state), which courts are ill-suited to do if compared with health author-
ities, courts could do a better job in overseeing and scrutinizing the procedure through
which these decisions were made and guaranteeing the adequate conditions for a fair
and rational decision.
97 Horowitz, supra n 70 at 141.

98 Ibid. at 207.
This is how the judiciary in England, Canada, Australia and New Zealand have
been judging claims for the provision of healthcare.99 Courts in these countries tend
to control health authorities’ decisions-making processes, giving special attention to
procedural fairness, transparency and factors that may have been overlooked by the
primary decision-maker. If a flaw in the process is found, instead of ordering the
provision of a treatment or the reallocation of healthcare resources, courts tend to,
by way of remedy, to quash the decision and remit the issue back to the government
authority for reconsideration in light of the judgment.
A similar approach in claims for health treatments is expected from Brazilian
courts with the enactment of Federal Law 12.401/11. Judicial control of procedure is

facilitated by a more inclusive, transparent, accountable and scientifically informed
health technology assessment system. Moreover, it can be expected that such a
procedure will be seen by courts as being more legitimate and hence attract greater
judicial deference.100 And considering that courts should take into account the
quality of the public authorities’ inquiry into the specific case, it also makes sense for
them to exercise deference for epistemic reasons.101
This would not make the right to health non-justiciable, but would imply a signifi-
cant change in the way it is interpreted by courts. Instead of judging the right to
health as an individual trump against rationing decisions made by the public health
system, it would be applied as the right to access a healthcare system in which
resources are distributed according to a fair process, which includes duties of
transparency, accountability, consistency and use of adequate evidence.102 Future
research will be able to assess the impact of Federal Law 12.401/11 to test whether
the most adequate response to right to health litigation was actually effective. If so,
then it will be interesting to note the paradox that litigation, by creating unfairness
and inefficiency, may have forced the SUS to be fairer and more efficient.
ACKNOWLEDGEMENT
Earlier versions of this paper were presented at the UCL Conference on Latin
American Law & Policy, at the XXXI International Congress of the Latin American
Studies Association and at the Getúlio Vargas Foundation Law School Research
Seminar. I am grateful to those who contributed to this article on those occasions. I
am also especially indebted to Conor Gearty, Thomas Poole and Octavio Ferraz for
comments on previous versions of this article. The usual disclaimer applies.
99 See Flood and Essajee, ‘Setting Limits on Health Care: Challenges In and Out of the Courtroom in
Canada and Down-Under’ in den Exeter and Buijsen (eds), Rationing Health Care: Hard Choices and
Unavoidable Trade-Offs (2012); Flood and Gross, supra n 2; Syrett, supra n 2; Newdick, supra n 2 at 107;
Newdick, ‘Accountability for Rationing – Theory into Practice’ (2005) 33 Journal of Law, Medicine and
Ethics 660.
100 The hypothesis that courts are more deferential to rationing decisions when health authorities’ reasons
and procedures are explicit was suggested by Daniels, supra n 89 at 123; Flood and Essajee, supra n 99
at 184.
101 On the idea of deference for epistemic reasons, see Kavanagh, ‘Defending Deference in Public Law and
Constitutional Theory’ (2010) 126 Law Quarterly Review 222; Allan, ‘Judicial Deference and Judicial
Review: Legal Doctrine and Legal Theory’ (2011) 127 Law Quarterly Review 117.
102 A similar idea of the right to health was proposed by Daniels, supra n 89 at 328–30.

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Human Rights Law Review Advance Access published October 1, 2015

Human Rights Law Review, 2015, 0, 1–25

Right to Health Litigation in Brazil: The

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* Assistant Lecturer, Queen Mary University of London ([email protected]).

C The Author [2015]. Published by Oxford University Press.

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Other articles, instead of analysing the percentage of lawsuits in which a non-

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B. How Courts Judge

27 Ministry of Health, Insulinas Análogas de Longa Duração – Relatório de Recomendação da Comissão

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[In choosing] between protecting the inviolability of the right to life, an

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I cannot accept that the lack of economic resources can be articulated to

Similarly, another Justice (Luiz Fux) reasoned:

I am very determined when it comes to hope. I never believed in the version

(i) Collective claims

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C. The Budgetary Impact

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52 See Landau, supra n 2.

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A. Self-Restraint and Institutional Capacity: Responses

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84 See Wang, supra n 43.

d. take judges to visit public health units.

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88 King, supra n 78 at chapter 9.

B. The Federal Law 12.401/11: Health Technology Assessment

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of health authorities. It created a specialized institution and an administrative process

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97 Horowitz, supra n 70 at 141.

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