This document summarizes Brazil's biotechnology sector and policies that support innovation. It outlines the national management committee and regulatory agencies that oversee biotechnology. It also discusses financing institutions and public laboratories. The document emphasizes that development of biotechnology is strategically important for generating business opportunities and solutions. It outlines several focus areas for Brazil's biotechnology industry including medicine, health, agriculture, and more.

1. Support:
Organized by:
GET TO KNOW
THE INNOVATIVE
BIOTECHNOLOGY
BRAND IN BRAZIL.
Innovation
is in our DNA
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2. BRBIOTEC BRASIL:
THE BRAZILIAN NATIONAL MANAGEMENT COMMITTEE – BRBIOTEC (brbiotec.org.br)
r)
DNA GENERATING
COORDINATION OF BIOTECHNOLOGY POLICY
National Biotechnology Centre (Centro Nacional de Biotecnologia - CNB)
http://www.desenvolvimento.gov.br/sitio/interna/interna.php?area=3&menu=2249
ea=3&menu=2249
3 49
INNOVATIVE BUSINESS Forum on Competition in Biotechnology (Fórum de Competitividade em Biotecnologia)
de
http://www.desenvolvimento.gov.br/sitio/interna/interna.php?area=3&menu=2255
rea=3&menu=2255
3 55
OPPORTUNITIES. REGULATORY AGENCIES
National Agency of Health Surveillance (Agência Nacional de Vigilância Sanitária - ANVISA)
gilância
http://www.anvisa.gov.br/
Ministry of Agriculture, Livestock and Food Supply (Ministério da Agricultura, Pecuária e Abastecimento - MAPA)
http://www.agricultura.gov.br/
National Technical Biosafety Committe (Comissão Técnica Nacional de Biossegurança - CTNBio)
cional
http://www.ctnbio.gov.br/
Genetic Heritage Management Council (Conselho de Gestão do Patrimônio Genético - CGEN)
o
http://www.mma.gov.br/port/cgen/index.cfm
National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa - CONEP)
nal
http://www.conselho.saude.gov.br/comissao/conep
Inter-ministerial Group for Intellectual Property (Grupo Interministerial de Propriedade Intelectual - GIPI)
ministerial
http://www.desenvolvimento.gov.br/sitio/interna/interna.php?area=3&menu=1780
?area=3&menu=1780
3 7
National Institute of Industrial Property (Instituto Nacional da Propriedade Industrial - INPI)
d de
http://www.inpi.gov.br/
National Institute of Metrology, Standardization and Industrial Quality (Instituto Nacional de
Metrologia, Normalização e Qualidade Industrial - INMETRO)
http://www.inmetro.gov.br/english/
FINANCING INSTITUTIONS
National Bank for Social and Economic Development (Banco de Desenvolvimento Econômico e Social - BNDES)
http://www.bndes.gov.br/english
Financing Institution for Projects and Studies, also known as the Brazilian Innovation Agency (Financiadora de Estudos e Projetos - FINEP)
http://www.finep.gov.br/
National Council of Scientific and Technological Development (Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq)
http://www.cnpq.br/english
Coordination for the Enhancement of University Level Personnel (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES)
http://www.capes.gov.br/
PUBLIC LABORATORIES
Oswaldo Cruz Foundation (Fundação Oswaldo Cruz - FIOCRUZ)
http://www.fiocruz.br/
Butantan Institute (Instituto Butantan - BUTANTAN)
http://www.butantan.gov.br/
Brazilian Agricultural Research Corporation (Empresa Brasileira de Pesquisa Agropecuária - EMBRAPA)
http://www.embrapa.br/english
BRASIL
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3. POLICIES Development in the biotechnology sector has always been
of strategic importance to the country, presenting countless
opportunities for the generation of new businesses and
THAT ENCOURAGE solutions for the demands made by Brazilian society.
This situation has led to the establishment of BRBIOTEC
INNOVATIVE BRASIL, a biotechnology business network. Its main goal is
to establish technical and business cooperation, integrating
ACTIVITIES companies, investors, teaching and research institutions,
science and technology institutes, entrepreneurs, supporting
IN ADVANCED agencies and government.
There are several challenges that confront the areas of
biotechnology research and innovation. Starting with the
BIOTECHNOLOGY. effective cooperation of all those involved resulting in
productive work, breaking through barriers and joining efforts
so that the results may indeed be transformed into products
All of this activity in Brazil is aimed at establishing an environment of
and services, thereby generating capital for the country and
cooperation between government and industry, while also strengthening the
bringing Brazil onto the world stage as a biotechnology leader.
biotechnology network within the country. One of the measures taken to advance
these goals is Decree No. 6041, passed on February 8, 2007, which implemented
the Biotechnology Development Policy, thereby establishing a sphere of
THE FUTURE OF BRAZILIAN BIOTECHNOLOGY.
government coordination, known as the National Biotechnology Committee
• Strengthening micro and small businesses, which are at the
(Comitê Nacional de Biotecnologia), and the Biotechnology Forum (Fórum de
Biotecnologia), providing another link to society. Law No. 11.196/2005, known as base of the biotechnology production chain in the country.
the Good Law, was also recently passed, which “establishes tax incentives and
• Encouraging and promoting cooperation between national and
financial subsidies for research” and offers incentives for hiring researchers with
foreign companies; and among key actors, such as research and
master’s or doctoral degrees, as well as additional incentives for teaching and
research institutions. teaching institutions, government institutions, investors, etc.
According to the federal government, the new policy will allow an investment of
• Disseminating products and services of network
some R$ 10 billion in biotechnology over the next ten years. Out of the total, 60%
companies within Brazil and abroad, through participation
of funding will be provided by the federal budget and resources from the National
Bank of Economic and Social Development (Banco Nacional de Desenvolvimento in trade fairs and missions.
Econômico e Social - BNDES), as well as from investment funds for research,
• Providing technical skills training at various levels to ensure
science and technology. It is expected that the remaining 40% will be invested by
the excellence of human resources within the sector in Brazil,
the private sector.
The development of the biopharmaceutical and food sectors has been further and thereby expanding the scope of activities.
encouraged by the work of the National Agency of Health Surveillance (Agência
• Creating a national observatory of biotechnology in all fields
Nacional de Vigilância Sanitária - ANVISA), the National Commission for Ethics
(business and technical) to help guide national policies of
in Research (Comissão Nacional de Ética em Pesquisa - CONEP), the National
Technical Biosafety Committee (Comissão Técnica Nacional de Biossegurança promotion and to encourage development in this area.
- CTNBio) and other governmental agencies. The Biosafety Law was passed
• Making relevant legislation available to all organizations involved,
five years ago, and it sets in place controls and standards for compliance with
so that Brazilian industry, as well as institutions related to federal
biosafety requirements following the principle of precaution.
In relation to the transfer of technology and the protection of intellectual property and state governments, may take an appropriate position.
of biotechnology products, the National Institute of Industrial Property (Instituto
• Informing the general public about partnership among
Nacional da Propriedade Industrial - INPI) actively participated in creating the
institutions that already carry out this kind of activity in the country.
Productive Development Policy for the biotechnology sector, and it has worked
to strengthen the intellectual property system in Brazil, considering all of the
• Encouraging scientific and commercial agreements
relevant issues within this sector. At the same time, INPI is working to improve
between partners in industry, research institutions
the efficiency of the patent process, reducing the necessary processing time.
and national and international universities.
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4. BRAZIL: BIODIVERSITY
THAT BOOSTS INVESTMENT
AND RETURNS.
As a result of the minimal impact felt from the 2009 world of highly qualified labor throughout the country. Presently,
FOCUSED ON THE MARKET, BRBIOTEC BRASIL ACTS IN A SEGMENTED MANNER:
economic crisis, Brazil has consolidated a stable economic Brazil has some 122 National Science and Technology
standing, which has enabled the country to maintain and, in Institutes (Institutos Nacionais de Ciência e Tecnologia - MEDICINE AND HEALTH
some cases, even increase investments in new technologies, INCTs – www.cnpq.br/programas/inct/_apresentacao), while • Technological development of recombining proteins
including biotechnology. some 10,000 doctors graduate annually. These figures indicate • Biomaterials using a rapid creation technology for prototypes used to form models
Biotechnology companies, most of them small to medium- that scientific production has tripled over the last 30 years in • Biomaterials for regeneration, repair and reconstruction of bone tissue
sized businesses, are organized around institutions and Brazil, accounting for 2.12% of the total scientific production • Biomaterials for dermatological and cosmetic use
associations, in order to increase their representational worldwide in 2008. • Reagents for in vitro diagnosis
capacity vis-à-vis society, government, companies and The country with the 5th largest mass in the world, Brazil • Reagents for immunochemistry
universities. Consequentially, since 2007, the Brazilian has a significant competitive advantage with respect to the • Immunoassay, flow cytometry, autologous quick anti-cancer cell vaccine, human vaccines, diagnosis kits
government has adopted a national public policy aimed at the development of agricultural and environmental activities. ANIMAL HEALTH
development of biotechnology. The country’s potential is vast, ranging from genetic exploration • Animal feed and products for animal health
More than R$ 511.4 million (approximately US$ 255 million) aimed at agricultural advancements to the use of molecular • Biopharmaceutical and biotechnological processes
has been invested in programs to support R&D activities, markers and applications of genetic engineering in bio- • Vaccines
develop technological and/or investment infrastructure, informatics. With regard to the environment, promising results
BIOPHARMACEUTICALS
through loans made directly to biotechnology companies. include a potential reduction in the use of pesticides, lower
• Technology for the production of human recombining insulin and other therapeutic proteins
Between 2009 and 2010, some US$ 1.2 billion will be invested. risks of contaminating rivers and underground waters, as well • Biopharmaceutical and biotechnological processes for human health
as potential applications for degraded lands. • Monoclonal antibodies for use in cancer treatment and antibodies for clinical use
In the area of human health, one of the principal Brazilian
BIOENERGY AND BIOFUELS
milestones has been the development of interdisciplinary
• Technology for the production of enzymes and second-generation ethanol (cellulosic ethanol)
BIOTECHNOLOGY IN BRAZIL: A DEVELOPING SECTOR. research with opportunities for forming strategic partnerships
• Technology for the production of enzymes to produce biofuels
This sector relies on scientific and technical support from between the areas of diagnostics/ therapy and biomolecular
institutions of higher learning as well as public and private materials. At the current stage of development, the Brazilian AGRICULTURAL INDUSTRIES
research centers, which actively participate in generating biomedical industry seeks partners for the large-scale • Biodegradable plastics, such as PHB and PHB-HV, made from sugar cane
biotechnology products and services, mainly in the areas of production of biotechnology products. In this area of industry, • Genomics, post-genomics and proteomics
agriculture, bio-energy, human health, animal health and the greatest demand is for enzymes and therapeutic proteins • Cloning and heterologous expression of proteins
• New technologies aimed at agriculture and livestock
the environment. derived from recombining DNA (biosimilar) technology,
• Agricultural biotechnology, improvement of foodstuffs and nutraceuticals
A study conducted by Global Bio-Economy Consulting LCC resulting from incentives that the pharmaceutical industry has
• Biological fixation of nitrogen
in 2006 ranks Brazil in 5th place worldwide in terms of the recently received for the development of new biotechnology
number of employees working in the biotechnology sector. products and for biopharmaceutical production platforms. THE ENVIRONMENT
Financing of activities in the innovation sector illustrates In the bioenergy sector, Brazil is one of the most important • Bioremedies;
an equilibrium in national investments in research and producers in the world, and it is a leader in the development • Use of waste for the production of biomaterials
development. Data released by the Ministry of Science and of related technologies and in consistent investments • New platforms for biological pest control
• Bioprospection of biodiversity and genetic inheritance
Technology demonstrates that 53% of investments came from in RD&I in this sector. Compared to all alternative fuels,
• Treatment of water, landfill gases, solid waste and industrial residue
the public sector and 44% from private enterprise. bioethanol is, without a doubt, the most important and the fuel
Government investment has also been responsible for the skill demonstrating the best commercial potential.
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