In Brazil, health is a fundamental right under the Constitution and the government has responsibility for the regulation and control of health activities and services, as well as sanitary and epidemiologic surveillance.
A Unified Health System, defined as a body of actions and health services provided by public organs and institutions at all government levels, is in charge of executing epidemiologic surveillance proceedings, including those for the purpose of recommending and adopting preventive measures and the control of diseases.
The Brazilian Penal Code provides for punishing whoever causes an epidemic or fails to comply with public health regulations, and Brazil is currently in the process of incorporating the revised International Health Regulations into its domestic legal system.
Recently, the Ministry of Health updated a Contingency Plan for the Ebola Disease designed to guide government actions to prevent and a possible epidemic in the country.
I. Constitutional Principles – Health
The Brazilian Constitution states that health is a right of all and a duty of the government, guaranteed by social and economic policies aimed at reducing the risk of disease and at the equal and universal access to actions and services for its promotion, protection, and recovery.
It further states that health activities and services are of public importance and it is the government’s responsibility to provide, in accordance with the law, for their regulation, supervision, and control. Such activities and services must be carried out directly or through third parties and also by individuals or legal entities. Public health activities and services are part of a regionalized and hierarchical network and constitute a unified system.
According to the Constitution, the Unified Health System (Sistema Único de Saúde, SUS) is responsible, inter alia, for the execution of actions regarding sanitary and epidemiologic surveillance, as well as those relating to the health of workers.
II. Unified Health System
The SUS was established by Law No. 8,080 of September 19, 1990, and, pursuant to article 4, is composed of the body of actions and health services provided by public organs and institutions at the federal, state, and municipal levels of direct and indirect administration, and by the foundations maintained by the government. Federal, state and municipal public institutions of quality control, research, and production of supplies and medications, including blood and blood products and health equipment, are also part of the SUS. The private sector can participate in the SUS in a complementary manner.
The SUS’s duties encompass, among other things, epidemiologic surveillance, which is defined as a group of actions that provide for the knowledge, detection, or prevention of any change in the determining and conditioning factors of individual or collective health, for the purpose of recommending and adopting measures to prevent and control diseases. Law No. 8,080 also provides for the organization of the SUS at the federal, state, and municipal levels; the attributes of each organization; and their competencies.
A. National Agency of Sanitary Surveillance
Pursuant to the authority in Law No. 8,080, on January 26, 1999, the government issued Law No. 9,782, which further defined the National System of Sanitary Surveillance (Sistema Nacional de Vigilância Sanitária), and created the National Agency of Sanitary Surveillance (Agência Nacional de Vigilância Sanitária, ANVISA).
ANVISA is a federal agency (autarquia sob regime especial) linked to the Ministry of Health the institutional purpose of which is to foster the protection of the health of the population by exercising sanitary control over the production and marketing of products and services subject to sanitary surveillance, including the environments, processes, supplies and technologies related to them, as well as the control of ports, airports and borders.
The activities of epidemiologic surveillance and vector control related to ports, airports, and borders must be executed by the ANVISA under the technical and normative guidance of the Ministry of Health. In addition, the agency is in charge of regulating, controlling, and inspecting products and services that pose a threat to public health. Law No. 9,782 details the goods and products subordinated to the control and inspection of the ANVISA. Decree No. 3,029 of April 16, 1999 approved the agency’s bylaws.
B. Secretariat of Health Surveillance
On August 7, 2013, Decree No. 8,065 granted to the Ministry of Health the authority to implement the national health policy, including the coordination and supervision of the SUS; responsibility for taking general preventive measures; and responsibility for the surveillance and sanitary control of borders, ports, and airports.
The Secretariat of Health Surveillance (Secretaria de Vigilância em Saúde, SVS) is one of the many organs within the organizational structure of the Ministry of Health and is composed of
- Department of Surveillance of Transmissible Diseases (Departamento de Vigilância das Doenças Transmissíveis);
- Department of Surveillance of Non-Transmissible Diseases and Health Promotion (Departamento de Vigilância de Doenças e Agravos não Transmissíveis e Promoção da Saúde);
- Department of Management of Health Surveillance (Departamento de Gestão da Vigilância em Saúde);
- Department of Surveillance, Prevention and Control of Sexually Transmitted Diseases, Acquired Immunodeficiency Syndrome and Viral Hepatitis (Departamento de Vigilância, Prevenção e Controle das Doenças Sexualmente Transmissíveis, Síndrome da Imunodeficiência Adquirida e Hepatites Virais); and
- Department of Environmental Health Surveillance and Worker’s Health (Departamento de Vigilância em Saúde Ambiental e Saúde do Trabalhador).
The SVS is responsible for coordinating the management of the National System of Health Surveillance (Sistema Nacional de Vigilância em Saúde), composed of
- National Subsystem of Epidemiologic Surveillance of Transmissible and Non-Transmissible Diseases (Subsistema Nacional de Vigilância Epidemiológica, de Doenças Transmissíveis, e de Agravos e Doenças Não Transmissíveis);
- National Subsystem of Environmental Health Surveillance, including Working Environment Conditions (Subsistema Nacional de Vigilância em Saúde Ambiental, incluindo Ambiente de Trabalho);33
- National System of Laboratories of Public Health (Sistema Nacional de Laboratórios de Saúde Pública);
- Health Surveillance Information Systems (Sistemas de Informação de Vigilância em Saúde);
- Programs for the Prevention and Control of Diseases of Public Health Relevance, including the National Program of Immunizations (Programas de Prevenção e Controle de Doenças de Relevância em Saúde Pública, incluindo o Programa Nacional de Imunizações); and
- National Policy on Worker’s Health (Política Nacional de Saúde do Trabalhador).
The SVS’s duties include, inter alia, preparation and disclosure of information and analysis of health situations enabling the establishment of priorities, monitoring the sanitary situation of the country, assessing the impact of actions taken for the prevention and control of diseases, and assisting the Ministry of Health with the development of policies. The SVS also coordinates activities related to preventing and controling diseases and participates in preparing and implementing norms, instruments, and methods to strengthen the capacity of the SUS in all three levels of government in the field of health surveillance.
C. Department of Surveillance of Transmissible Diseases
The Department of Surveillance of Transmissible Diseases is responsible, among other things, for
- Proposing norms related to (a) procedures for the prevention and control of transmissible diseases; (b) notification of transmissible diseases; (c) epidemiologic investigation; and (d) epidemiologic surveillance at ports, airports, borders and customs terminals;
- Establishing preventive measures and control of risk factors and diseases;
- Supplementary or complementary coordination of epidemiologic measures and control of diseases in exceptional situations, when (a) the capacity of a State is surpassed; (b) there is the involvement of more than one State; or (c) there is a risk of national dissemination;
- Regulation and definition of technical instruments related to information systems regarding the mandatory notification of diseases and diseases under surveillance;
- Analysis, surveillance, supervision and orientation in the execution of actions for the prevention and control of diseases that are part of a list of diseases requiring mandatory notification, or that may become important for public health;
- Monitoring the epidemiologic behavior of diseases under surveillance;
- Preparing the national list of diseases requiring mandatory notification;
- Preparing a basic mandatory vaccination plan;
- Coordination of investigations related to outbreaks and epidemics; and
- Regulation and supervision of the National System of Laboratories of Public Health with respect to health surveillance.
1. Epidemiologic Surveillance Guide
In 1975, the Ministry of Health created the National System for Epidemiologic Surveillance (Sistema Nacional de Vigilância Epidemiológica, SNVE). The SNVE was established by Law No. 6,259 of October 30, 1975, which was regulated by Decree No. 78,231 of August 12, 1976.
Law No. 6,259 provided for the organization of epidemiologic surveillance actions, created the national program of immunizations, and made mandatory the communication of the presence of selected diseases.
In 1977, the Ministry of Health prepared the first Epidemiologic Surveillance Manual (Manual de Vigilância Epidemiológica), which gathered all technical norms being used for the surveillance of each disease within the ambit of specific control programs. The manual is still being published by the Ministry of Health and its last updated version was issued in 2009.
With the promulgation of Law No. 8,080 on September 19, 1990, the SUS incorporated the SNVE, which further defined epidemiologic surveillance and re-organized the health system in the country.
2. Rapid Response Center
In 1990, the government merged two agencies in charge of public health and created the National Health Foundation (Fundação Nacional de Saúde, FUNASA), an entity responsible for health promotion and protection, promoting sanitation solutions for prevention and control of diseases, and preparing and implementing actions to promote and protect health related actions established by the National Sub-System of Environmental Health Surveillance.
On August 31, 2000, FUNASA created the Rapid Response Center for Epidemiologic Emergencies (Núcleo de Resposta Rápida em Emergências Epidemiológicas, NUREP) to act in the following cases:
- Epidemics that go beyond the limits of a state
- Epidemics of emerging diseases
- Introduction into the country of an infectious agent that had been eradicated or did not previously exist
- Epidemics of diseases that are part of the International Sanitary Regulation
- Epidemics characterized by an expansion to areas without previous occurrences
- Floods, droughts, and other calamities and/or disasters relevant to public health when insufficient action is demonstrated by a municipality or state
NUREP is also responsible for planning, mobilizing resources, coordinating and implementing actions that reduce or eliminate risks to public health; maintaining information systems regarding human resources and logistics available for mobilization; and preparing procedural manuals for interventions in emergency situations.
III. Patent Breach
In cases of national emergency or public interest, the government may issue a compulsory license for the use of a patent if the owner of the patent or its licensee does not comply with a request for its use. The national emergency must have been declared by an act of the executive branch of the federal government, and the compulsory license must be temporary and non-exclusive, and may not cause prejudice to the rights of the owner.
On October 6, 1999, Decree No. 3,201 was issued to regulate the issuance of compulsory licenses in cases of national emergency and public interest. The decree further: (1) determines that in cases of public interest the compulsory license is for noncommercial public use only; (2) defines “national emergency” as an imminent public danger, even if it is only in part of the country; (3) defines “public interest” as the facts related, inter alia, to public health and environmental protection, as well as those of fundamental importance to the technological or socio-economic development of the country; and (4) regulates the procedures that must be observed for the issuance of a compulsory license.
IV. Right to Privacy
According to the Brazilian Constitution, everyone is equal before the law, with no distinction whatsoever, and Brazilians and foreigners residing in the country are guaranteed the inviolate right to life, liberty, equality, security, and property.
As part of the fundamental rights and guarantees established in the Constitution, personal intimacy, private life, honor, and reputation are inviolable, and the right to compensation for pecuniary or moral damages resulting from violations of such rights is guaranteed. In addition, the Constitution provides that an individual’s home is inviolable, and no one may enter it without the dweller’s consent, except in cases of a flagrant crime (flagrante delito) or disaster, or to provide help, or during the day with a court order.
The Brazilian Medical Code of Ethics provides that a medical doctor must keep secret all information that he or she has access to while performing his duties, except in cases provided by law. However, a physician is authorized to disclose information acquired while exercising his or her profession in cases of justified motive (justa causa), legal obligation, or written authorization of the patient.
V. Criminal and Civil Sanctions
The breach of government determinations designed to prevent the introduction or propagation of a contagious disease is punished by up to one year in prison and the payment of a fine, and Medical doctors that fail to communicate to health authorities the presence of diseases under the mandatory notification system are punished by up to two years in prison and the payment of a fine.
In addition to the criminal sanctions established in the Penal Code, Law No. 6,437 of August 20, 1977 lists the situations that characterize infringement of federal sanitary laws and their respective penalties.
VI. International Health Regulations
Brazil is a member of the World Health Organization (WHO) and the Pan American Health Organization (PAHO), and follows the International Health Regulations (IHR) adopted by the WHO in 1969 and later amended in 1973 and 1981.
In 1995, the 48th World Health Assembly called for a substantial revision of the Regulations adopted in 1969. After extensive work, on May 23, 2005, IHR (2005) was adopted by the 58th World Health Assembly and on June 15, 2007, it entered into force.
The purpose and scope of the IHR (2005) are “to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.”
IHR (2005) was incorporated into Brazil’s domestic legal system through Legislative Decree No. 395/2009.
VII. Recent Developments
On August 8, 2014, the Ministry of Health updated the Contingency Plan for Emergency in Public Health – Disease for Ebola Virus (Plano de Contingência para Emergência em Saúde Pública – Doença Pelo Vírus Ebola), which was designed to guide specific actions against a possible introduction of the Ebola virus in the country.
The Plan defines responsibilities on the federal level and establishes the necessary organization in order to respond to emergency situations related to this disease in Brazil, aiming at the integration of actions and prevention and control.
The objectives of the Plan are as follows:
- Define the operating strategy of the Ministry of Health in line with the definitions of the Response Plan for Public Health Emergencies
- Establish a coordinated response within the scope of the Unified Health System
- Activate Emergency Operation Centers in Public Health to manage a coordinated response
- Adopt measures to prevent the spread of the Ebola virus on an eventual introduction of the virus in the country
- Establish the use of standard protocols and procedures to respond to Ebola
Prepared by Eduardo Soares
Senior Foreign Law Specialist
 Constituição Federal [C.F.] art. 196, http://www.planalto.gov.br/ccivil_03/Constituicao/Constituicao.htm.
 Id. art. 197.
 Id. art. 198.
 Article 198 of the Constitution also provides the organizational directives that must be followed by the unified health system.
 Id. art. 200(II).
 Lei No. 8.080, de 19 de Setembro de 1990, http://www.planalto.gov.br/ccivil_03/Leis/L8080.htm.
 Direct Administration is considered to be the body of public administrative services exercised directly by the government (federal, state, and municipal) through government organs, such as ministries and secretaries, which are integrated into the structure of the Executive. Indirect Administration is the body of acts and services rendered by decentralized administrative agencies (autarquias) or public entities created by law, in the exercise of their own activities or government functions, through delegation by the government. Maria Helena Diniz, 1 Dicionário Jurídico 123–24 (São Paulo, Editora Saraiva 2005).
 Lei No. 8.080, art. 4(§1).
 Id. art. 4(§2).
 Id. art. 6(I)(b).
 Id. art. 6(§2).
 Id. art. 9.
 Id. art. 15.
 Id. art. 16.
 Id. arts. 6(§1), 15–18.
 Lei No. 9.782, de 26 de Janeiro de 1999, art. 3, http://www.planalto.gov.br/ccivil_03/Leis/L9782.htm.
 Id. art. 6.
 Id. art. 7(§3).
 Id. art. 8.
 Decreto No. 3.029, de 16 de Abril de 1999, http://www.planalto.gov.br/ccivil_03/decreto/D3029.htm.
 Decreto No. 8,065, de 7 de Agosto de 2013, http://www.planalto.gov.br/ccivil_03/_Ato2011-2014/2013/Decreto/D8065.htm#art7.
 Id. Anexo I, art. 1(I).
 Id. art. 1(II).
 Id. art. 1(VI).
 Id. art. 2(II)(e)(1).
 Id. art. 2(II)(e)(2). Article 42 of Decree No. 8,065 defines the competence of the Department of Surveillance of Non-Transmissible Diseases and Health Promotion.
 Id. art. 2(II)(e)(3). Article 43 of Decree No. 8,065 defines the competence of the Department of Management of Health Surveillance.
 Id. art. 2(II)(e)(4). Article 44 of Decree No. 8,065 defines the competence of the Department of Surveillance, Prevention and Control of Sexually Transmitted Diseases, Acquired Immunodeficiency Syndrome and Viral Hepatitis.
 Id. art. 2(II)(e)(5). Article 45 of Decree No. 8,065 defines the competence of the Department of Environmental Health Surveillance and Worker’s Health.
 Id. art. 40(I)(a).
 Id. art. 40(I)(b).
 Id. art. 40(I)(c).
 Id. art. 40(I)(d).
 Id. art. 40(I)(e).
 Id. art. 40(I)(f).
 Id. art. 40(II).
 Id. art. 40(III), (IV).
 Id. art. 40(VII).
 Id. art. 41(I).
 Id. art. 41(II).
 Id. art. 41(III).
 Id. art. 41(IV).
 Id. art. 41(V).
 Id. art. 41(VI).
 Id. art. 41(VII).
 Id. art. 41(VIII).
 Id. art. 41(IX).
 Id. art. 41(X).
 Ministério da Saúde, Guia de Vigilância Epidemiológica 17, 18 (7ª Edição, Brasília, DF, 2009), http://bvsms.saude.gov.br/bvs/publicacoes/guia_vigilancia_epidemiologica_7ed.pdf.
 Decreto No. 78.231, de 12 de Agosto de 1976, http://www.planalto.gov.br/ccivil_03/decreto/1970-1979/D78231.htm.
 Lei No. 6.259, de 30 de Outubro de 1975, art. 2, http:// www.planalto.gov.br/ccivil_03/Leis/L6259.htm.
 Id. art. 3.
 Id. art. 7.
 Ministério de Saúde, supra note 51.
 Lei No. 8.080, de 19 de Setembro de 1990, art. 6(§2), http://www.planalto.gov.br/ccivil_03/Leis/L8080.htm.
 Lei No. 8.029, de 12 de Abril de 1990, art. 14, http://www.planalto.gov.br/ccivil_03/LEIS/L8029cons.htm#art14.
 Decreto No. 7.335, de 19 de Outubro de 2010, Anexo I, art. 2, http://www.planalto.gov.br/ccivil_03/_Ato2007-2010/2010/Decreto/D7335.htm#art6.
 Ministério de Saúde , Portaria No. 473, de 31 de Agosto de 2000, art. 1, http://www.jusbrasil.com.br/diarios/ 1420127/pg-105-secao-1-diario-oficial-da-uniao-dou-de-04-09-2000.
 Id. art. 1.
 Id. art. 2(I).
 Id. art. 2(II).
 Id. art. 2(III).
 Lei No. 9.279, de 14 de Maio de 1996, art. 71, http:// www.planalto.gov.br/ccivil_03/Leis/L9279.htm.
 Decreto No. 3.201, de 6 de Outubro de 1999, http://www.planalto.gov.br/ccivil_03/decreto/D3201.htm.
 Id. art. 2(§1).
 Id. art. 2(§2).
 Id. art. 5.
 C.F. art. 5.
 Id. art. 5(X).
 Id. art. 5(XI).
 Federal Council of Medicine, Resolução CFM No. 1.931, de 17 de Setembro de 2009, http://www.portal.cfm.org.br/index.php?option=com_content&view=category&id=9&Itemid=122.
 Id. ch. I, no. XI.
 Id. art. 73.
 Código Penal, Decreto-Lei No. 2.848, de 7 de Dezembro de 1940, art. 267, http://www.planalto.gov.br/ ccivil_03/Decreto-Lei/Del2848compilado.htm.
 Id. art 267(§1).
 Id. art 268.
 Id. art. 269.
 Lei No. 6.437, de 20 de Agosto de 1977, art. 10, http://www.planalto.gov.br/ccivil_03/Leis/L6437.htm.
 Id. art 2.
 Pan American Health Organization, http://www.paho.org/hq/index.php?option=com_wrapper&view= wrapper&Itemid=2005&lang=en.
 WHO, International Health Regulations (2d ed. 2005), http://www.who.int/ihr/ publications/9789241596664/en/.
 Id. at 1.
 Decreto Legislativo No. 395, de 2009, http://www2.camara.leg.br/legin/fed/decleg/2009/decretolegislativo-395-9-julho-2009-589324-publicacaooriginal-114307-pl.html.
 Ministério da Saúde, Secretaria de Vigilância em Saúde, Departamento de Vigilâncias das Doenças Transmissíveis, Plano de Contingência para Emergência em Saúde Pública, Doença pelo Vírus Ebola Versão 5 (Brasília, DF, 2014), http://www.ribeiraopreto.sp.gov.br/ssaude/doencas/ebola/plano_contingencia.pdf.
 Id. at 4.
Last Updated: 06/09/2015