RIGHT TO MEDICINES GRAZIELLE DAVID ALANE ANDRELINO NATHALIE BEGHIN - ASSESSMENT OF EXPENDITURES ON MEDICINES WITHIN THE FEDERAL SCOPE OF SUS ...
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RIGHT TO
MEDICINES
ASSESSMENT OF EXPENDITURES
ON MEDICINES WITHIN THE FEDERAL
SCOPE OF SUS BETWEEN 2008-2015
GRAZIELLE DAVID
ALANE ANDRELINO
NATHALIE BEGHINRIGHT TO
MEDICINES
ASSESSMENT OF EXPENDITURES PREPARED BY
ON MEDICINES WITHIN THE FEDERAL
SCOPE OF SUS BETWEEN 2008-2015
GRAZIELLE DAVID SUPPORTING ENTITY
ALANE ANDRELINO
NATHALIE BEGHIN
FIRST EDITION
BRASÍLIA/DF | 2016INESC TEAM Social Educators
Fátima Correia Lopes
Steering Council Thallitta de Oliveria Silva
Adriana de Carvalho Barbosa Ramos Barreto Walisson Lopes de Souza
Enid Rocha Andrade da Silva
Guacira Cesar de Oliveira Accountancy
Luiz Gonzaga de Araújo Rosa Diná Gomes Ferreira
Sérgio Haddad
Assistant of Accountancy
Fiscal Council Ricardo Santana da Silva
Ervino Schmidt
Romi Márcia Bencke IT Technician
Taciana Maria de Vasconcelos Gouveia Ricardo Santana Primo
Suplente: Augustino Pedro Veit
Administrative Assistant
Management Board Adalberto Vieira dos Santos
Iara Pietricovsky de Oliveira Eugênia Christina Alves Ferreira
José Antonio Moroni Isabela Mara dos Santos da Silva
Josemar Vieira dos Santos
Policy Advisory Coordinator
Nathalie Beghin General Services Assistant
Roni Ferreira Chagas
Financial, Administrative and Personnel Manager
Trainees
Maria Lúcia Jaime
Caroline Macêdo de Lima
Vinicius Moreira
Assistant of Management
Ana Paula Felipe
Marcela Coelho Monteiro Esteves Institutional Support
Policy Advisory Charles Stewart Mott Foundation, Christian Aid, Fastenopfer, FAC-G-
Alessandra Cardoso DF – Fundo de Apoio à Cultura, Fundação Avina em parceria com a
Carmela Zigoni OAK Foundation e ICS, Fundação Heinrich Böll, Fundação Ford, GDF –
Cleomar Souza Manhas Secretaria da Criança, GDF – Secretaria do Trabalho, Desenvolvimento
Grazielle Custódio David Social, Mulheres, Igualdade Racial e Direitos Humanos, IBP – Center on
Márcia Hora Acioli Budget and Policy Priorities, KNH – Kindernothilfe, Norwegian Church
Aid (NCA), Oxfam Brasil, Pão para o Mundo, Serviço Protestante para
Technical Advisory o Desenvolvimento (PPM), Petrobras, União Européia, Unicef
Dyarley Viana de Oliveira
Higor dos Santos Santana Inesc – Institute for Socioeconomic Studies
Janaína Roseli M. dos Santos Address: SCS Quadra 01 - Bloco L, nº 17, 13º Andar Cobertura
Edifício Márcia 70. 3037-900 - Brasília/DF
Communication Advisory Phone: + 55 61 3212-0200 E-mail: inesc@inesc.org.br
Jorge Henrique Cordeiro Website: www.inesc.org.brCONTENTS
ACRONYMS .................................................................................................................................................................................................................................... 5
1. INTRODUCTION ........................................................................................................................................................................................................... 7
2. METHODOLOGY ......................................................................................................................................................................................................... 8
3. MAIN RESULTS ............................................................................................................................................................................................................ 10
3.1 Social Security Budget 2008 – 2015.................................................................................................................................................. 10
3.2 Ministry of Health expenditures on medicines .......................................................................................................................................... 13
3.2.1 General evolution 2008 – 2015 ......................................................................................................................................... 13
3.2.2 Evolution of expenditures by component .................................................................................................................... 14
3.3 The phenomenon of judicialization of medicines................................................................................................................. 23
4. FINAL CONSIDERATIONS ........................................................................................................................................................................... 26
REFERENCES ......................................................................................................................................................................................................................... 31
ANNEXES .................................................................................................................................................................................................................................. 37RIGHT TO MEDICINES
ABIA Associação Brasileira Interdisciplinar de Aids
ASSESSMENT OF EXPENDITURES
(Brazilian Interdisciplinary AIDS Association)
ON MEDICINES WITHIN THE FEDERAL
SCOPE OF SUS BETWEEN 2008-2015 ANVISA Agência Nacional de Vigilância Sanitária
(National Health Surveillance Agency)
Realization CAP Coeficiente de Adequação de Preços
Instituto de Estudos Socioeconômicos – INESC (Price Adjustment Ratio)
CBAF Componente Básico da Assistência Farmacêutica
Support (Basic Pharmaceutical Assistance Component)
Open Society Foundations – OSF CEAF Componente Especializado de Assistência Farmacêutica
(Specialized Pharmaceutical Assistance Component)
Authors CEF Constituição Federal
Grazielle David (Federal Constitution)
Alane Andrelino CESAF Componente Estratégico da Assistência Farmacêutica
Nathalie Beghin (Strategic Pharmaceutical Assistance Component)
CGPLAN Coordenação Geral de Planejamento e Orçamento
Text Review (Planning and Management Secretariat)
Paulo Henrique de Castro COFIN Comissão de Orçamento e Financiamento
(Editora Palomitas) do Conselho Nacional de Saúde
(Budget and Finance Committee, National Health Council)
Translation COFINS Contribuição Social para o
Master Language Traduções e Interpretação Financiamento da Seguridade Social
(Social Contribution for the Financing of Social Security)
Graphic Design CONASEMS Conselho Nacional de Secretários Municipais de Saúde
Paulo Roberto Pereira Pinto (National Council of Municipal Health Secretaries)
(Ars Ventura Imagem e Comunicação) CONASS Conselho Nacional de Secretários Estaduais de Saúde
(National Council of State Health Secretaries)
CONITEC Comissão Nacional de Incorporação
It is allowed total or partial reproduction of de Tecnologias no SUS
the present content, as long as the source is (National Commission on the Incorporation
acknowledged. of Technologies in SUS)
CPGF Cartão de Pagamento do Governo Federal
(Federal Government Payment Card)
July 2016 CSLL Contribuição Social sobre o Lucro Líquido das Empresas
(Social Contribution on Net Profits)
DOU Diário Oficial da União
(Federal Official Gazette)
DRU Desvinculação dos Recursos da União
(Detachment of Federal Revenues)ACRONYMS
DSEIs Distritos Sanitários Especiais Indígenas PIS Programa de Integração Social
(Special Indigenous Health Districts) (Social Integration Program)
FNS Fundo Nacional de Saúde PMGV Preço Máximo de Venda ao Governo
(National Health Fund) (Maximum Government Sale Price)
GDP Gross Domestic Product PPA Plano Plurianual
GM Gabinete do Ministro (Multi-Year Plan)
(Minister’s Office) RAG Relatório Anual de Gestão
GTPI/REBRIP Grupo de Propriedade Intelectual da Rede (Annual Management Report)
Brasileira pela Integração dos Povos RENAME Relação Nacional de Medicamentos Essenciais
(Intellectual Property Group, Brazilian (National List of Essential Medicines)
Network for the Integration of Peoples) RGPS Regime Geral da Previdência Social
HEMOBRAS Empresa Brasileira de Sangue e Hemoderivados (General Social Security Scheme)
(Brazilian Company of Biotechnology and Blood Products) SAS Secretaria de Atenção à Saúde
IBGE Instituto Brasileiro de Geografia e Estatística (Health Care Secretariat)
(Brazilian Institute of Geography and Statistics) SCTIE Secretaria de Ciências, Tecnologia
INESC Instituto de Estudos Socioeconômicos e Insumos Estratégicos
(Institute for Socioeconomic Studies) (Science, Technology and
IPCA Índice de Preços ao Consumidor Amplo Strategic Inputs Secretariat)
(Expanded Consumer Price Index) SESAI Secretaria Especial de Saúde Indígena
IPEA Instituto de Pesquisa Econômica Aplicada (Special Indigenous Health Secretariat)
(Institute of Applied Economic Research) SIOP Sistema de Informações sobre Orçamento Público
LAI Lei de Acesso à Informação (Public Budget Information System)
(Access to Information Act) SIOPS Sistema de Informações sobre
LOA Lei Orçamentária Anual Orçamentos Públicos em Saúde
(Annual Budget Law) (Public Health Budget Information System)
MS Ministério da Saúde SISPAG Sistema de Pagamentos do
(Ministry of Health) Fundo Nacional de Saúde
(National Health Fund
MSF Médicos Sem Fronteiras
Payment System)
(Doctors Without Borders)
OGU Orçamento Geral da União SUS Sistema Único de Saúde
(Federal Budget) (Unified Health System)
OSF Open Society Foundation STF Supremo Tribunal Federal
(Federal Supreme Court)
PASEP Programa de Formação do Patrimônio do Servidor Público
(Civil Service Asset Formation Program) SVS Secretaria de Vigilância em Saúde
(Health Surveillance Secretariat)
PDP Parceria para o Desenvolvimento Produtivo
(Partnership for Productive Development) TCU Tribunal de Contas da União
(Federal Audit Court)
PEC Proposta de Emenda Constitucional
(Constitutional Amendment Proposal) WHO World Health Organization
RIGHT TO MEDICINES 5RIGHT TO MEDICINES
1. INTRODUCTION through three schemes: Corporate Network, Here there is
a Popular Pharmacy and Health is Priceless.
The provision of public health services has advanced Access to medicines is essential in ensuring the con-
significantly since the implementation of the Unified stitutional right to health, but the difficulty to ensure it
Health System (SUS). Nevertheless, Brazil has failed to has been reason for concern. The causes for this diffi-
meet all the health needs of individuals, particularly as culty are diverse, ranging from the lack of qualified per-
regards the supply of medicines, an important element sonnel to manage pharmaceutical assistance to financial
to fulfill the integrality principle of the health system. constraints.
However, it should be noted that Brazil is the only country To further exacerbate this context, there is the fact
with more than 100 million people with a public, univer- that medicines are considered by the market as products
sal, comprehensive and free health system that caters to that generate significant profits, especially with patents on
the entire population, which is a huge challenge. drug innovations, regulated by the Treaty on Intellectual
The publication of the 1998 National Medicines Property. As a result, in the last two decades there has
Policy fostered the creation of programs aimed at ensur- been a significant increase in the number of “new medi-
ing access to medicines by the population. The latest reg- cines”, which are usually very expensive due to patents, but
ulations governing the budget issue of Pharmaceutical not always have an additional therapeutic value. Despite
Assistance are: Ordinance GM/MS No. 204 of 29 January this finding, the use of these products is promoted by the
2007, establishing the pharmaceutical assistance financ- pharmaceutical industry through marketing among doc-
ing package through basic, strategic and specialized tors and patients, which helps pressure the health system
components; and Ordinances GM/ MS 1554 and 1555, to incorporate these products without proper regulation.
both of 30 July 2013. Faced with this scenario and feeling that their de-
In addition to the pharmaceutical assistance financ- mands for health care are not being met by the public
ing components, Law No. 10,858 of April 2004 created system, patients have increasingly resorted to the court to
Brazil Popular Pharmacy Program, which was regulated by gain access to medicines for their treatment. This phenom-
Decree No. 971 of 17 May 2012. The Program is funded enon, known as judicialization, has become relevant and
RIGHT TO MEDICINES 7controversial due to the different interests and actors in- actors as regards the medicines policy in the country. When
volved. The result is a growing demand by citizens, through available, this information will enable making work-related
the courts, for the provision of medicines and treatments suggestions to ensure the realization of the right to health,
that are not covered by the public health network. mainly in the access to medicine dimension.
The demand for medicines through judicialization has
been controversial due to its effects on the financing of the 2. METHODOLOGY
health system. On the one hand, it is argued that access to
medicines is essential to ensure the right to health, what- This study, of an exploratory character, was based on
ever the cost. On the other, it is claimed that resources are data relating to the medicines budget between 2008 and
finite and that if it is not possible to regulate access to med- 2015 within the federal scope of SUS – Unified Health
icines, the resources should be reallocated, thus bringing System, using expenditures paid in the year, plus the bal-
loss to other people, since court decisions must be com- ance payable in the same year1 (paid + balance payable
plied with. In other words, the judicialization of medicines paid), collected through the following sources: Annual
compromises the equity of the health system and contrib- Budget Laws; Annual Management Reports of the
utes to undermine the sustainability not only of the medi- Ministry of Health Secretariats; Health Care Secretariat
cines policy in particular but of the health policy in general. (SAS); Technology and Strategic Inputs Secretariat
Considering all these phenomena involving access (SCTIE); Health Surveillance Secretariat (SVS); National
to medicines, this exploratory study, the result of a part- Health Fund (FNS); information systems such as the Public
nership between INESC and the Open Society Foundation Health Budget Information System (SIOPS), Public Budget
(OSF), aims to better understand the so-called “ Medicines Information System (SIOP) and SIGA BRAZIL; plus requests
Budget.” It is a survey and an assessment of budget data using the Access to Information Act (LAI)
on medicines within the scope of the Ministry of Health, Note that to better understand the behavior of the
its evolution between 2008 and 2015 and how much is variables studied, we have chosen to analyze the past eight
invested in medicines by programmatic action under the years, in order to match them with the Ordinance regulat-
Annual Budget Law (LOA). Note that this period has been ing the funding blocks and the National Pharmaceutical
chosen because it refers to the last two federal govern- Assistance Policy that were approved with effect from 2008
ment Multi-annual Plans (PPA). Moreover, since 2008 and with the last two PPA (Multi-year Plan - 2008-2011 and
various procedures have been regulated, thus facilitating 2012-2015), which are the guiding documents of public pol-
access to information. icies for the four federal government years. Working from
This deeper knowledge of the Medicines Thematic the PPA perspective proved to be the best option because
Budget in Brazil is key to advance the understanding of the
priorities expressed in public spending in this area and to
1 The balance payable amount has been included because it accounts for
provide additional studies evaluating the most influential about 15% of the Ministry of Health’s expenditures each year.
8 RIGHT TO MEDICINESof the different methods tested for the collection of data ▪▪ The Federal Official Gazette (DOU) provided
on the Medicines Budget, the one by budgetary programs data on the unit value of products purchased to
and actions, as provided for in the public policy planning comply with court decisions.
document, proved to be the most accurate (see Annex 1 ▪▪ Data on the budget execution of medicines in the
for the programs and actions that are part of the Ministry indigenous health care subsystem and data on ex-
of Health’s Medicines Budget). Data collection for financ- penditures on lawsuits were requested via the LAI.
ing blocks and sub-function was also tested, but in both ▪▪ The balance payable amounts paid were taken
methods the data did not correspond exactly to what was from the Management reports of the Ministry of
informed by each Ministry of Health secretariat in the annu- Health Secretariats posted on the TCU (Federal
al management reports (RAG). This mismatch may be due Audit Court2) website.
to different ways of reporting the stages of expenditures.
Data on the Social Security budget were collected Tables, boxes and graphs were prepared based on this
from SIOP and data relating to health expenditure as a information to illustrate the results found. All figures have
proportion of Gross Domestic Product (GDP) were collect- been updated to March prices according to the 2016 IPCA
ed from the World Health Organization website (WHO). – Expanded Consumer Price Index of the Brazilian Institute
Data on virtually all medicines were taken from the of Geography and Statistics (IBGE). This index was chosen
SCTIE Annual Management Reports, except those that because it is the one the Ministry of Health uses to update
had to be collected from the following sources: the prices of medicines. We have also chosen to include the
Medicines Budget in the broader context, since the inclusion
▪▪ SAS Annual Management Reports provided the of Health in Social Security and of Medicines in Health.
data related to expenditure on medicines in From the results found INESC promoted in late
the Coagulopathies Program and the Food and May 2016 a one-day work meeting in Brasilia, with
Nutrition Program. the participation of civil society organizations [Brazilian
▪▪ SESAI Annual Management Reports enabled ac- Interdisciplinary AIDS Association (ABIA); Working Group
cessing data related to the flow of expenditures on Intellectual Property of the Brazilian Network for the
on medicines for the indigenous population. Integration of Peoples (GTPI/REBRIP); Doctors without
▪▪ Data related to the flow of expenditures on im- Borders (MSF); Gestos – HIV-positive Communication
munobiologicals were collected from the SVS and Gender and National Health Council]; and the feder-
Annual Management Reports. al government [Ministry of Health, Institute of Economic
▪▪ The National Health Fund provided information Applied Research (IPEA); National Council of Municipal
on the general budget execution between 2008
and 201; data on the overall budget execution be-
2 https://contas.tcu.gov.br/econtasWeb/web/externo/listarRelatorios-
tween 2012 and 2015 were collected from SIOPS. GestaoAnteriores.xhtml.
RIGHT TO MEDICINES 9Health Secretaries (CONASEMS); National Health Agency 87/2015, which aims at expanding the DRU to 30%, and
(ANVISA)]. During the event, the study was presented and PEC 143/2015, which proposes the detachment of federal
discussed among participants, thus improving its content revenue of around 25% for states and municipalities. This
and identifying proposals and suggestions for future directly affects the Health sector, since its financing is tri-
work. This version of the document incorporates much of partite, i.e., it involves the three levels of government.
the debates that took place during that meeting. Chart 1 shows the data for the Social Security
Budget for the period 2008-2015 by each of its compo-
3. MAIN RESULTS nents: Social Welfare, Social Assistance and Health; in
addition to the national GDP figures for each year. The
3.1 Social Security Budget 2008 – 2015 data in absolute values are contained in Annex 2.
The Federal Budget is formed by the Fiscal Budget Chart 1: Social Security Budget, 2008- 2015
and the Social Security Budget. According to article 194 of
the 1988 Federal Constitution it “comprises an integrated 800.000.000.000
700.000.000.000
whole of actions initiated by the Government and by soci- 600.000.000.000
ety, with the purpose of ensuring the rights to health, so- 500.000.000.000
400.000.000.000
cial security and assistance”. Therefore, the health budget
300.000.000.000
is included in the Social Security budget which, together 200.000.000.000
with the Fiscal Budget make up the Federal Budget. 100.000.000.000
0
Social Security has a diversity of sources of revenue 2008 2009 2010 2011 2012 2013 2014 2015
from the federal government, states and municipalities, Social Welfare Social Assistance Health Social Security
and social contributions by companies and workers. These
sources include: Social Security Contribution to the General Source: SIOP
* Figures updated by the IPCA - March 2016.
Social Welfare Scheme (RGPS); Social Contribution on Net Prepared by the authors.
Profits (CSLL); Social Contribution for the Financing of
Social Security (COFINS); Contribution to PIS/ PASEP; social Over the eight years assessed, GDP grew 27.5% and
contributions on lotteries, etc. the Social Security Budget 42.5%, whereas the Welfare
However, the federal government uses the Detach- Budget increased by 40.5%, the Social Assistance Budget
ment of Federal Revenues (DRU) as a mechanism to make by 70.4% and the Health Budget by 36.7% - represent-
the final destination of Social Security revenue more flexi- ing the lowest growth among the three Social Security
ble. Currently, the DRU can reach 20% of Social Security. components.
The situation is expected to worsen: the National Congress Noteworthy is the fact that in 2015 there was a real
is discussing Constitutional Amendment Proposal (PEC) decrease in the Social Security Budget. Chart 2 shows this
10 RIGHT TO MEDICINESdecrease specifically in the case of health. The absolute annually in public health services and actions the amount
numbers are contained in Annex 3 of this document. corresponding to at least:
The situation of health is even more dramatic, since
the decrease in resources is related not only to the time I) 13.2% of net current revenue in 2016;
of national economic crisis and the strategy of cuts ad- II) 13.7% of net current revenue in 2017;
opted by the federal government, but also to a legal III) 14.1% of net current revenue in 2018;
change - Constitutional Amendment 86/2015, which IV) 14.5% of net current revenue in 2019;
led to the reduction of the health funding base in rela- V) 15% of net current revenue in 2020 and beyond.
tion to what had been previously regulated.
However, 13.2 % of the current net revenue in 2016
Chart 2: Health Budget, 2008-2015 resulted in amounts lower than those invested in 2015,
representing another setback and aggravating the SUS
120.000.000.000
underfunding situation. The estimated loss reaches R$10
100.000.000.000
billion, according to the Budget and Finance Committee
80.000.000.000
of the National Health Council (COFIN). PEC 01/2015 was
60.000.000.000
proposed in an attempt to reverse this scenario, as it rais-
40.000.000.000
es these minimum percentages to 15%, 16%, 17%, 18
20.000.000.000
% and 18.7% respectively. No date has yet been set for
0
2008 2009 2010 2011 2012 2013 2014 2015 the PEC to be voted, and there is no prospect of broad
Health – nominal values Health – values correct by the IPCA parliamentary support. On the other hand, PEC 87/2015,
Source: SIOPS and FNS which increases the DRU and creates the detachment of
* Values updated by the IPCA - March 2016. revenues of states and municipalities has already been ap-
Prepared by the authors.
proved in the amount of 25%, which will entail reducing
Under Complementary Law 141/2012, the Federal health financing at the sub-national level, thus worsening
Government should invest annually on public health the SUS underfunding situation.
services the amount corresponding to that committed Another extremely harmful legislative proposal not
in the previous financial year, calculated in accordance only to Health but to the whole of Social Security is PEC
with this Supplementary Law, plus at least the per- 241/16, which provides that for a period of 20 years the
centage corresponding to the nominal growth of the increase in primary expenditure will be limited to the
Gross Domestic Product (GDP) in the year preceding the inflation increase in the previous year. This in practice
Annual Budget Law. means there will be no real increases in spending. This
However, Constitutional Amendment 86/2015 de- measure, if passed by Congress, will result in the viola-
termined that the Federal Government should invest tion of rights and increased poverty and inequality.
RIGHT TO MEDICINES 11To give an idea of the impact of this measure on public While the average GDP percentage spent on health is 8%
health, if it had been enforced in 2003, the Ministry’s bud- in Brazil, in countries like England and Canada,3 which have
get would have endured an accumulated loss of R$318 universal health systems, amounts around 8% correspond
billion between 2003 and 2015, which corresponds to to what is invested in public health alone. It is still possible
three years of budget based on 2015 (see Table 1). This to see in Table 2 that between 2008 and 2013 both public
poses a serious risk on the right to health in Brazil and, and private spending on health remained stable.
consequently, on the right to medicines. Finally, Chart 3 shows that the average health ex-
Federal SUS underfunding is still seen when assessing penditure from the Federal Budget was 8.8%, with an
the GDP percentage spent on health between 2008 and upward trend between 2013 and 2015, which will pos-
2013 (the last year with data available on IBGE’s website). sibly be reduced in 2016 as a result of EC 86.
Table 1: Health expenditure under EC-29 and PEC-241*
HEALTH EXPENDITURE ESTIMATED HEALTH LOSS (-) OR LOSS (-)
Year
UNDER EC 29 EXPENDITURE UNDER PEC 241 GAIN (+) OR GAIN(+) %
2002 Base Year
2003 54,777 56,098 1,320 2.35%
2004 61,251 56,984 -4,267 -7.49%
2005 65,826 58,014 -7,812 -13.46%
2006 70,014 59,448 -10,566 -17.77%
2007 72,869 58,697 -14,173 -24.14%
2008 75,592 57,899 -17,693 -30.56%
2009 86,763 58,781 -27,982 -47.60%
2010 87,116 57,893 -29,223 -50.48%
2011 95,484 57,572 -37,912 -65.85%
2012 99,858 57,931 -41,926 -72.37%
2013 97,807 57,893 -39,914 -68.94%
2014 101,704 57,621 -44,083 -76.50%
2015 100,055 55,403 -44,652 -80.59%
ESTIMATED ACCUMULATED LOSS -318,882
Thousands of reals at constant prices
Source: Inter-institutional Technical Group on the Discussion of SUS Financing
* Amounts at March 2016 prices 3 WHO (http.who.int/gho/data/node.country.country).
12 RIGHT TO MEDICINESTable 2: Proportion of health expenditures relative to GDP, to the Federal Government Budget and to pri-
vate expenditures, 2008-2013
GDP % spent on total health GDP % spent on public health GDP % spent on private health
2008 8,0 3,5 4,5
2009 8,4 4,4 3,6
2010 8,0 3,6 4,4
2011 7,8 3,5 4,3
2012 7,8 3,4 4,4
2013 8,0 3,6 4,4
Source: IBGE. http://www.ibge.gov.br/home/estatistica/economia/economia_saude/css_2010_2013/defaulttab_xls.shtm
Chart 3: Federal Budget Percentage spent on Health 74% from R$8.5 billion at the beginning of the series to
12
R$14.8 billion in 2015. This percentage is nearly twice
10 that observed for health as a whole, which is 36.6%. This
8 continuous upward trend started in 2011: since then the
6 amounts allocated to medicines have increased, including
4
in 2015 when the health budget fell in real terms.
2
0
2008 2009 2010 2011 2012 2013 2014 2015 Chart 4: Evolution of budget expenditure on med-
Source: Siga Brasil and National Health Fund - FNS icines in the Ministry of Health, 2008-2015
* Figures updated by the IPCA - March 2016.
Prepared by the authors
16
Billions
14
3.2 Ministry of Health expenditures on Health 12
10
– The Medicines Budget
8
6
3.2.1 General evolution 2008 – 2015 4
2
0
In 2015, the Ministry of Health spent in real terms 2008 2009 2010 2011 2012 2013 2014 2015
R$14.8 billion on medicines, which corresponded to
Nominal value Updated value
13.7% of its total budget (Charts 4 and 5; the absolute
values are
contained in Annex 4). Note that between 2008 Source: National Health Fund - FNS and RAG
* Figures updated by the IPCA - March 2016.
and 2015 the funds allocated to medicines increased by Prepared by the authors.
RIGHT TO MEDICINES 13Chart 5: Percentage of expenditures on medicines 3.2.2 Evolution of expenditures by component
in relation to the Ministry of Health’s total Budget, for the period 2008-2015
2008-2015
15
Expenditure on medicines is distributed into three
components divided into 9 programmatic actions, ac-
10 cording to the National Medicines Policy. The description
5 of each component is shown in Box 1.
0 Box 1 - Description of the Ministry of Health’s Medi-
2008 2009 2010 2011 2012 2013 2014 2015
cines Budget Components
Nominal value W Updated value
Source: National Health Fund - FNS and RAG
* Figures updated by the IPCA - March 2016.
Prepared by the authors. Basic Pharmaceutical Assistance Component
(CBAF): intended for the purchase of pharma-
As regards the comparison of expenditures on med- ceutical assistance medicines within the scope
icines in relation to the Federal Budget, Chart 6 shows of primary health care and those related to spe-
a growth of 2.46 percentage points from 11.22% in cific diseases and health programs, as shown in
2008 to 13.67% in 2016. Annex I of the National List of Essential Medicines
(RENAME). Its funding is subdivided into fixed
Chart 6: Percentage of expenditures on medicines and variable funding, made through transfers
in relation to the Federal Budget, 2008-2015 to states and/or municipalities. Centrally, the
Ministry of Health purchases and distributes
16 NPH insulin and contraceptives.
Billions
14
12 Specialized Pharmaceutical Assistance Com-
10 ponent (CEAF): intended for the purchase and
8
distribution of medicines based on criteria estab-
6
4 lished in the Clinical Protocols and Therapeutic
2 Guidelines, according to Annex III of the Nation-
0 al List of Essential Medicines (RENAME). budget
2008 2009 2010 2011 2012 2013 2014 2015
spending is subdivided into fixed and variable
Nominal value Updated value
Source: Follow Brazil, National Health Fund (FNS) and RAG
* Figures updated by the IPCA - March 2016.
Prepared by the authors.
14 RIGHT TO MEDICINES▪▪ Coagulopathies;
funding, divided into three groups: I - exclusive
▪▪ Sexually Transmitted Diseases and Ac-
Federal Government funding; II - state funding; III
quired Immune Deficiency Syndrome
- tripartite funding. The Federal Government also
(STD/AIDS);
purchases 6 cancer drugs under this component.
Food and Nutrition: National iron supplemen-
Strategic Pharmaceutical Assistance Compo-
tation Program, NutriSUS Program, National
nent (CESAF): intended for pharmaceutical as-
Program for the Control of Vitamin A Deficiency.
sistance actions under strategic health programs.
The Ministry of Health is responsible for preparing Popular Pharmacy: Program implemented in 2004
treatment protocols, as well as for the planning, and regulated in 2012, with funding shared by the
the centralized purchase and the distribution to private network (Here There Is a Popular Pharmacy)
States of medicines, products and inputs for the and the public network (Popular Pharmacy of
other levels of care, according to Annex II of the Brazil) and the Health is Priceless Program, available
National List of Essential Medicines (RENAME). in both the public and private network for asthma,
The State Health Secretariats are responsible for diabetes and hypertension medicines.
the storage and distribution of products to re-
gional secretariats or municipalities. The guaran- SESAI: The procurement of medicines under the
tee of access to medicines falls under the respon- Indigenous Health Care Subsystem is shared by
sibility of the Strategic Component: the Special Indigenous Health Secretariat (SESAI)
and the Special Indigenous Health Districts (DSEIs)
▪▪ Focal Endemic Diseases: Dengue, Malaria, through decentralized resource and bidding pro-
Leprosy, Leishmaniasis, Chagas Disease, Schis- cesses of their own and the Federal Government
tosomiasis, Tuberculosis and other endem- Payment Card (CPGF).
ic diseases of national or regional scope. As
seen, this component is mainly targeted at an Judicialization: At the federal level, the resourc-
important group of so-called neglected dis- es needed to meet these expenses are funded
eases, or poverty-related diseases; according to the budget availability of program-
▪▪ Smoking; matic pharmaceutical assistance actions, usually
▪▪ Influenza/H1N1; through action No. 4705 (CEAF) of the Multi-
▪▪ Immunobiologicals; Year Plan (PPA).
RIGHT TO MEDICINES 15Table 3 shows the evolution of expenditures by and the Federal District based on the per capita expense,
components and programmatic actions of pharmaceu- and the variable expense refers to the centralized purchase
tical assistance. See also the chart in Annex 5. of medicines [contraceptives for the Women’s Health
In 2015, three actions alone accounted for 76.8% Program, Human Insulin (NPH and Regular), medicines
of expenditures on medicines: CEAF, Immunobiologicals and inputs that make up the Pharmaceutical Assistance
and Popular Pharmacy. These were also the ones with Kit for people affected by natural disasters, and medi-
the highest growth rates between 2008 and 2015. In cines and inputs that make up the kit for assistance to
2008 the scenario was different: CEAF CBAF and STD/ the prison population)]. Since the promulgation of Decree
AIDS accounted for most of the expenditures. The evo- No. 2,765/2014, the funds for the Prison System kit have
lution of the expenditures component of the Medicines been provided by means of fund to fund transfers.
Budget for the period 2008-2015 is analyzed below. It is important to note that both the budgetary sta-
The Basic Pharmaceutical Assistance Component bility of the CBAF in recent years - which did not follow
(CBAF) has remained relatively stable over the years. It is the increase in unit values of primary care drugs - and
funded through fixed and variable expenses (see Chart 7). the absence of state and municipal financial contribu-
The fixed expense corresponds to the amount transferred tion, under MS Ordinance 1555/2013, have prevented
by the National Health Fund (FNS) to states, municipalities the purchases from meeting the demand, thus leading
Table 3: Expenditures on medicines, by Component and Programmatic Action, 2008 - 2015
Constant Reals
Farmácia Alim. e
CESAF CBAF DST/AIDS CEAF Imunobiol. Coagulopat. SESAI Gasto anual
Popular Nutrição
2008 192.638.429 1.369.886.111 1.553.969.351 3.540.509.772 977.328.460 358.648.611 527.912.840 42.267.693 8.563.161.267
2009 1.056.159.928 1.348.292.800 1.689.652.480 4.123.126.144 591.533.277 466.881.601 558.090.691 34.676.757 10.506.539.477
2010 212.029.050 1.455.932.810 859.565.769 4.632.814.953 1.085.743.875 476.155.023 492.684.836 30.465.008 9.245.391.324
2011 216.131.328 1.414.192.640 1.073.721.759 4.698.184.092 736.901.239 550.421.119 1.033.434.613 11.565.341 9.734.552.132
2012 154.675.740 1.343.993.378 1.027.346.286 5.092.012.678 606.547.777 333.750.352 1.758.812.850 3.655.402 10.320.794.462
2013 159.256.966 1.433.300.042 909.705.556 5.879.109.756 767.626.366 240.416.085 2.192.884.101 4.271.832 11.586.570.704
2014 187.708.533 1.472.951.372 984.731.808 5.573.065.051 1.214.652.061 415.885.358 2.930.044.462 4.552.387 14.829.872 14.125.828.628
2015 257.001.529 1.564.789.840 1.008.877.660 6.040.371.675 2.546.481.977 590.285.553 2.859.859.326 1.957.234 23.746.764 14.893.371.557
Source: SIOPS, FNS, RAG and LAI
* Figures updated by the IPCA at March 2016 values
Prepared by the authors.
16 RIGHT TO MEDICINESto shortages of essential medicines. On the other hand, Chart 8: Expenditure on medicines under the spe-
the increase in the amount intended for centralized pur- cialized component (CEAF), 2008-2015
chases can be explained by the increase in insulin costs.4
7.000
Millions
6.000
Chart 7: Expenditure on medicines under the basic
5.000
component (CBAF), 2008-2015 4.000
3.000
1800
2.000
Millions
1600
1.000
1400
1200 0
1000 2008 2009 2010 2011 2012 2013 2014 2015
800 Nominal value Updated value
600
400
200 Source: FNS, RAG and LAI
0 * Figures updated by the IPCA at March 2016 values
2008 2009 2010 2011 2012 2013 2014 2015 Prepared by the authors
Total nominal value Nominal value of transfer Updated total value
Source: FNS, RAG and LAI Regarding the Strategic Pharmaceutical Assis-
* Figures updated by the IPCA at March 2016 values
Prepared by the authors tance Component (CESAF) in the programmatic ac-
tion for Focal Endemic Diseases, tuberculosis, lep-
The Specialized Pharmaceutical Assistance Com- rosy, influenza and smoking, the budget remained
ponent (CEAF), formerly called “high cost medicines,” relatively steady between 2008 and 2015 in real terms
represents, for the most part, medicines of higher unit (see Chart 9). The exception was 2009, when signifi-
cost; moreover, this action also funds 6 high-cost can- cant increase in expenditure was recorded, which cor-
cer drugs and many of the medicines purchased by responds to the purchase of Oseltamivir for the influen-
court decision. All these elements explain the weight of za pandemic. Since 2013, an important portion of this
these expenditures (around 40% of the total) as well budget has been earmarked for the purchase of Paliv-
as their significant growth in the period under study - of izumab (which is the object of many lawsuits) used for
more than 70% from R$3.5 billion to R$6.0 billion be- the prevention of infection by the respiratory syncytial
tween 2008 and 2015 (see Table 3 and Chart 8). virus (RSV), and the reason for the increase recorded in
2015. What draws attention is the fact that this compo-
nent is the only one with a budget execution well below
4 The cost of NPH insulin rose from R$5.48 in 2008 to R$23.79 in 2015, the initial allocation, possibly due to budget forecasting
an increase of 334%. As inflation in the period was 64.49%, the actual
increase was 269.51%. for a possible endemic outbreak.
RIGHT TO MEDICINES 17Chart 9: Expenditures on medicines under CESAF Chart 10: Expenditures on medicines under the stra-
- Focal endemic diseases, tuberculosis, leprosy, in- tegic component (CESAF - STD/AIDS), 2008-2015
fluenza and smoking, 2008-2015
2.000
Millions
1.500
1.200
Millions
1.000
1.000
500
800
0
600
2008 2009 2010 2011 2012 2013 2014 2015
400 nominal value updated value
200
Source : FNS, RAG and LAI
0 * Figures updated by the IPCA at March 2016 values
2008 2009 2010 2011 2012 2013 2014 2015 Prepared by the authors
nominal value updated value
The PDPs, which are partnerships involving coopera-
Source: FNS, RAG and LAI
* Figures updated by the IPCA at March 2016 values tion through agreements between public institutions and
Prepared by the authors
private entities, are linked to the Productive Development
Policy (2008) and are part of a strategy that uses the SUS
Still under the CESAF component in the STD/AIDS purchasing power to: a) promote the development of
programmatic action, although its budget remained the production capacity of the national pharmaceuticals
virtually steady between 2010 and 2015, there was a industry (chemical or biotechnological base); b) stimulate
significant decrease in 2010 (see Chart 10). A possible the local production of products that have a high cost and/
explanation is that the expanded partnership between or major health and social impacts; c) strengthen public
the Ministry of Health and public laboratories through laboratories and strengthen their market regulation role.
the Partnerships for Productive Development (PDP), as PDPs are coordination tools of industrial develop-
shown in Chart 11, led to a reduction in the cost of ment actions and regulation within the scope of the
these medicines. Still, a 50% reduction in the amount health care industry; however, these partnerships ex-
spent cannot be explained by this partnership alone, pose the fragility of Brazil amidst the intellectual prop-
as the medicines will still need to be purchased from erty and monopolistic practices of the international
public laboratories, even if at a lower cost. In addition, pharmaceutical industry, and therefore are a hindrance
the increased number of people on treatment and the to the national sovereignty as regards ensuring essen-
change in treatment protocols would entail an increase tial medicines within SUS. In this sense, many times it is
in expenditures. convenient to maintain the PDPs to ensure agreements
18 RIGHT TO MEDICINESwith large pharmaceutical companies without generat- the French company Baxter. From 2014, expenditures
ing important transfers of innovative technologies. began to grow again due to the increased purchase of
Factor VIII recombinant. This increase was due to the
Chart 11: Evolution in the amounts of Antiretrovi- growth in the proportion of its use in treatments. Initially,
ral purchased by type of supplier, 2008-2015 the proportion was 70% for Factor VIII plasmatic vs. 30%
for Factor VIII recombinant. However, currently the pro-
portion reaches 50% for each, and factor VIII plasmatic
350.000.000 costs 0.322/IU while Factor VIII and recombinant costs
Pharmaceutical units
300.000.000
0.84/IU. Therefore, Factor VIII recombinant is 160.87%
250.000.000
more expensive than Factor VIII plasmatic.
200.000.000 Private
150.000.000 Public
100.000.000 Linear (Private) Chart 12: Expenditures on medicines under the
50.000.000 Linear (Public) strategic component (CESAF – Immunobiologicals)
0 , 2008-2015
2008 2009 2010 2011 2012 2013
Source: DAF/Ministry of Health 0 www.saude.gov.br/cesaf)
Year .
3.000
Millions
2.500
Under the CESAF component in the programmatic 2.000
action for Immunobiologicals (see Chart 12), the bud- 1.500
get growth observed is possibly related to the expansion 1.000
of vaccination coverage, with the introduction of new 500
0
vaccines in the annual calendar (human rotavirus, menin- 2008 2009 2010 2011 2012 2013 2014 2015
gococcal conjugate C, pneumococcal 10- valent, inacti- nominal value updated value
vated poliovirus (IPV), pentavalent, tetraviral (oral), hep-
atitis A, DTPa and HPV) , epidemiological variation and Source: FNS, RAG and LAI
* Figures updated by the IPCA at March 2016 values
expansion of target groups for vaccination (Brazil has ex- Prepared by the authors.
tended vaccination for hepatitis B available until 19 years
of age to risk groups and adults from 20 to 49 years). Still under the CESAF component, programmatic
Still under the CESAF component in programmat- actions 8735 and 20QH for the Food and Nutrition
ic action for Coagulopathies (see Chart 13), there was Program, which includes the National Program for
decrease in budget expenditure in 2012 and especially in Iron Supplementation, the NutriSUS Program and
2013, possibly due to the partnership between Hemobrás the National Program for the Control of Vitamin A
(Brazilian Company of Biotechnology and Blood Products) Deficiency [currently within the Brasil Carinhoso (Caring
via PDPs (Partnerships for Productive Development) and Brazil) Program] show a significant drop in expenditures
RIGHT TO MEDICINES 19from 2011 (see Chart 14). There is no explanation in the Chart 14: Expenditures on medicines under the
Annual Management Reports (RAG) for a decrease in strategic component (CESAF - Food and Nutrition)
expenditures in 2011 and 2012. In turn, in 2013 the na- 2008-2015
tional iron supplementation program was decentralized 45
Millions
and is now under the responsibility of municipalities. 40
35
30
Chart 13: Expenditures on medicines under the 25
strategic component (CESAF – Coagulopathies), 20
2008-2015 15
10
5
0
700
2008 2009 2010 2011 2012 2013 2014 2015
Millions
600
500 nominal value updated value
400 Source: FNS, RAG and LAI
300 * Figures updated by the IPCA at March 2016 values
Prepared by the authors
200
100
0 Among the causes for the increase in expenditures
2008 2009 2010 2011 2012 2013 2014 2015
is the growth in the number of accredited private phar-
nominal value updated value
macies that operate through copayment and also the
Source: FNS, RAG and LAI
* Figures updated by the IPCA at March 2016 values
implementation of the “Health is Priceless” Program
Prepared by the authors in 2012, which covers mainly the free distribution of
medicines for asthma, hypertension and diabetes. The
In 2015, the entire expenditure on the Strategic number of pharmacies in the governmental network
Component (CESAF) totaled R$1.8 billion, while the has remained steady since 2011 (see Charts 16 and 17).
Specialized Component (CEAF) reached R$ 6.0 billion. The “ Popular Pharmacy of Brazil Program”, es-
It should be noted that CESAF caters to more patients tablished by Law 10,858/2004, has become one of the
than CEAF. most popular social policies. In its first phase, the pro-
The Popular Pharmacy Program, related to ac- gram included a partnership with Fiocruz for the cre-
tions 20YR and 20YS for program maintenance, has ation of a governmental network of public pharmacies
expanded its budget since 2011 by more than five-fold in order to provide essential medicines at a low cost. At
from R$527.9 million in 2008 to R$ 2.86 billion in 2015, the time of the purchase, the government subsidized up
thus expressing the priority assigned to it by the Ministry to 90% of the cost of medicines, while users were re-
of Health (see Chart 15). sponsible for the remainder 10% through copayment.
20 RIGHT TO MEDICINESChart 15: Expenditures on medicines under the Pop- agreements with commercial (private) pharmacies. In this
ular Pharmacy Program, 2008-2015 modality, the federal government directly subsidizes up
to 90% of the cost of medicines included in the program
3.500
and monitors its execution, while the pharmacies are re-
Millions
3.000
2.500
sponsible for the planning, purchase and distribution of
2.000 medicines under the program.
1.500
1.000
500
Chart 17: Popular Pharmacy Program: Number of
0 Accredited Pharmacies and Drugstores, 2009-2015
2008 2009 2010 2011 2012 2013 2014 2015
nominal value updated value
40.000
33.264 33.854
35.000
29.559
Source: FNS, RAG and LAI 30.000
* Figures updated by the IPCA at March 2016 values 25.126
25.000
Prepared by the authors 20.101
20.000
14.003
15.000
10.790
10.000
Chart 16: Popular Pharmacy Program: Number of 5.000
Pharmacies, Government Network, 2008-2015 0
2009 2010 2011 2012 2013 2014 2015
600 555 558 556 558 Source : DAF/Ministry of Health
528
503
500
406
400 In 2011 the federal government introduced anoth-
300 254
er modality called “Health is Priceless”, establishing that
medicines for diabetes, hypertension and asthma would
200
be fully subsidized by the government in all pharmacies
100
participating in the program, both in the government
0
2008 2009 2010 2011 2012 2013 2014 2015
and private networks, with no copayment by users.
It is very common for users to go back and forth
between basic SUS pharmacies and Popular Pharmacies.
Source : DAF/Ministry of Health
Although both are supported by public funds, the
Municipal Health Secretariats fail to prioritize the pur-
In a second phase, in 2006, another modality called chase of primary care medicines that are also found
“Here there is a Popular Pharmacy” was created through in the Popular Pharmacies. This measure is considered
RIGHT TO MEDICINES 21advantageous because it reduces expenditures on the purchase and the Special Indigenous Health Districts -
purchase of these medicines. However, this does not DSEIs (decentralized procurement with bidding process-
hold true for SUS users, since in the primary care phar- es of their own and through the Federal Government
macy the medicine would be free, while in the Popular Payment Card - CPGF), as shown in Chart 19.
Pharmacy, for most medicines, users have to pay a per-
centage of the cost (copayment). Chart 19: Centralized or decentralized expendi-
tures on medicines under the Attention to Indige-
Chart 18: Expenditures on Medicines under the In- nous Health Care Subsystem
digenous Health Care Subsystem, 2014 and 2015
R$25.000.000,00
25.000.000,00 R$20.000.000,00
20.000.000,00 R$15.000.000,00
Título do Eixo
R$10.000.000,00
15.000.000,00
nominal value
R$5.000.000,00
10.000.000,00 updated value
R$0,00
5.000.000,00 2 3
0,00 Centralized procurement Decentralized procurement
2014 2015
Source: LAI
Source: RAG, SESAI and LAI * Figures updated by the IPCA at March 2016 values
* Figures updated by the IPCA at March 2016 values Prepared by the authors
Prepared by the authors.
Decentralization has not guaranteed the supply
With regard to Indigenous Health, under SESAI of medicines in the territories, as contained in SESAI’s
(Special Indigenous Health Secretariat), data were avail- RAG, and was audited by the Federal Audit Court
able only for financial years 2014 and 2015 through the (TCU). Importantly, due to economies of scale, purchas-
Access to Information Act, since programmatic action es by the Ministry of Health reduce the cost of medi-
20YP is not restricted just to the purchase of medicines cines to levels below those recorded by some DSEIs in
for the indigenous population. Also, they have a list of ComprasNet.5
medicines of their own, according to Ordinances GM/
MS No. 1059 and No.1800, both of 2015.
The purchase of medicines under the Indigenous 5 ComprasNet - Federal Government procurement portal established by the
Ministry of Planning, Budget and Management to provide society with
Health Care Subsystem is shared by SESA (centralized data on tenders and contracts.
22 RIGHT TO MEDICINES3.3 The phenomenon of judicialization of Table 4: Budget for lawsuits - SCTIE / DELOG. Di-
medicines rect purchases, 2008-2015
Constant Reals
At the federal level, the financial resources nec- Year Amount Percentage Growth
essary to meet the expenses arising from lawsuits are
2008 103,804,742.04
provided according to the budget availability of the
pharmaceutical assistance programmatic actions. The 2009 172,301,348.36 65.99%
general flow of lawsuits on medicines and inputs in the 2010 187,348,132.55 8.73%
Ministry of Health is shown in Annex 6. 2011 291,608,097,56 55.65%
It is important to note that it is possible that the
2012 416,557,501.98 42.85%
claimant will receive the medicine three times as a result
of a court decision, since there is no crossing of data 2013 516,797,086.61 24.06%
from the databases of lawsuits of federal entities. Thus, 2014 823,736,160.42 59.39%
if the claimant appeals to the municipality, the state
2015 1,110,613,298.96 34.83%
and the federal government, he or she may receive the
medicine from all of them simultaneously, without one Source: Annual report of management SCTIE
* Figures updated by the IPCA at March 2016 values
knowing that the other has already provided it. Prepared by the authors.
The procurement of medicines to comply with court
decisions occurs according to the following criteria: Table 5: Budget for lawsuits - FNS. Deposit in man-
date accounts, 2012-2015
▪▪ Direct purchase - SCTIE / DELOG (see Table 4); Constant Reals
▪▪ Use of the Ministry of Health’s strategic stock; Year Amount Percentage Growth
▪▪ Payment directly to the beneficiary of the law-
2012 43,442,024.22
suit (see Table 5);
▪▪ Payments to private entities and health funds; 2013 114,054,087.10 163%
2014 140,928,311.40 24%
With regard to direct purchases, between 2008 2015 41,976,703.70 -70%
and 2015 the funds allocated for the judicialization of Source: FNS and SEGEPLAN
Prepared by the authors
medicines increased more than tenfold in real terms * Figures updated by the IPCA at March 2016 values
** The breakdown by lawsuits was recorded in the electronic system of the Na-
from R$103 million in 2008 to R$1.1billion in 2015 (see tional Health Fund from 2012 alone in the Payment System (SISPAG). Therefore,
Table 4). Compared to the Medicines Budget, at the be- there was no information available for previous years.
*** In the deposit in mandate account, CAP is not applied on the factory price (FP),
ginning of the series the percentage was just over 1%; which is mandatory in public purchases of medicines to comply with judicialization,
and that increases the unit value.
in 2015 it rose to nearly 8%.
RIGHT TO MEDICINES 23Entities such as the National Council of State As expenditures on the judicialization of medicines
Health Secretaries (CONASS) and National Council of are included neither in the annual health plans nor in
Municipal Health Secretaries (CONASEMS) draw at- the LOA (Annual Budget Law), their payment should
tention to the fact that lawsuits on medicines mitigate be made using funds from the existing components.
impacts on the annually planned budget and conse- Through the RAGs it was noted that this usually occurs
quently in users’ access. Thus, for example, according through action No. 4705 (CEAF) of the Multi-Year Plan
to the 2013 Annual Management Report of the SCTIE, (PPA). This is reflected in the exponential increase in ex-
expenditures on lawsuits reached, in real terms, R$80.4 penditures on the CEAF component, since if the judi-
million of the budget of the Strategic Pharmaceutical cialization were excluded, there would be no need to
Assistance Component (CESAF), representing 50.5% of substantially increase the budget for that component,
the entire budget of action 4368 (CESAF) in 2013. for there is not a significant variation in the number of
The evolution of expenditures on lawsuits for the patients of diseases covered by that component, as is
period 2008-2015 is shown in Chart 20. In the peri- the case of rare diseases, rheumatoid arthritis and some
od under analysis there was a real increase of 1006% cases of hepatitis.
in lawsuits met by direct purchases and deposits, from In recent years, already anticipating the lawsuits,
R$103.8 million in 2008 to R$1.1 billion in 2015. In the the Ministry of Health claims to have “hyper insufflat-
same period, the Ministry of Health’s Medicines Budget ed” the budget allocation for CEAF. However, when
increased by only 74%. evaluating the LOA, the initial allocation for this com-
ponent jumped from R$3,540,509,000 in 2008 to
Chart 20: Ministry of Health’s Medicines Budget - R$6,040,371,000 in 2015, representing an increase
Total expenditures on lawsuits, 2008-2015 of 71%, which is much lower than the percentage in-
crease in lawsuits. Moreover, not even the sum of the
increases in the expenditures of all components can fol-
1.400,00
low the increase in expenditures on lawsuits.
Millions
1.200,00
1.000,00 As the real increase in the Medicines Budget was
800,00 around 74% in the period 2008-2015 and the increase in
600,00
the judicialization of medicines was greater than 1000%,
400,00
200,00
it is possible to infer that even though this expense is
0,00 being considered by the Ministry of Health, the budget
2008 2009 2010 2011 2012 2013 2014 2015
forecast for the Pharmaceutical Assistance components
Purchase Account deposits
is necessarily below the actual needs of the population.
Source: SCTIE and FNS. Especially when considering that the Brazilian population
Prepared by the authors.
* Figures updated by the IPCA at March 2016 values grows and the prices of medicines increase.
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