An Acad Bras Cienc (2021) 93(Suppl. 4): e20210413 DOI 10.1590/0001-3765202120210413
Anais da Academia Brasileira de Ciências | Annals of the Brazilian Academy of Sciences
Printed ISSN 0001-3765 I Online ISSN 1678-2690
www.scielo.br/aabc | www.fb.com/aabcjournal
ECOSYSTEMS
New Law of Brazilian Biodiversity: Legal Aspects
and Impact in the Field of Biotechnology
MARCELO FOLGOSI, ALESSANDRA L. VALVERDE, SORELE B. FIAUX, SAMANTA C.
MOURÃO, RICARDO H. LEAL, ALOYSIO M.F. CERQUEIRA, SÁVIO F. BRUNO, OLIVIA
V.D. WEID, RENATA ANGELI, JOSÉ C.D. NETO, MIRIAM A. DE SOUZA, RITA L. PAIXÃO,
GUTEMBERG G. ALVES, MARCELO S. GONZALEZ & SELMA R. DE PAIVA
Abstract: Access to genetic resources (GR) and/or traditional knowledge associated
with genetic resources (ATK) has been regulated in Brazil since 2001. The law 13,123 /
2015 determined a significant change in the theme, mainly on the rules of distribution
of benefits obtained for conservation and sustainable use of biodiversity, the access
to technology and technology transfer, the exploitation of products or reproductive
material from the GR or ATK and consignment to the outside of part or all the living
or dead organism shipped for GR. The implementation of international treaties on GR
and ATK for research, biotechnological development and bioprospecting have been
causing difficulties for Brazilian researchers, mainly due to the lack of information and
dissemination available for compliance with the legislation. In this work, the members
of the Committee for Access to Genetic Resources and Associated Traditional Knowledge
of the Federal Fluminense University (UFFGEN) - Brazil, and collaborators performed
a critical reflection on the new law, helping Brazilian researchers with information
necessary to understand the changes made by the new legislation, especially in the
field of Biotechnology associated with Brazilian Biodiversity.
Key words: Genetic resources, associated traditional knowledge, benefit sharing,
biotechnology.
INTRODUCTION
Init ially, law 13,123 / 2015 defines GR as
information on the genetic origin of plant,
animal, microbial or other species, including
substances from the metabolism of these living
beings and ATK as information or practice of the
indigenous population, traditional community,
or traditional farmer about the properties on
direct or indirect uses associated with the GR.
Established at the United Nations Conference
on Environment and Development held in
Rio de Janeiro in 1992 (popularly termed ECO
92), and enforced on December 29, 1993, the
Convention on Biological Diversity (CBD) (UNO
1992, Brazil 1998) set-forth a legal framework that
was established for the formation of national
and international standards. These standards
centered on five main objectives:
1 - “The conservation of biological diversity”
2 - “The sustainable use of its components”
3 - “The fair and equitable sharing of benefits
arising from the use of GR and the adequate
transfer of relevant technologies, taking into
account all rights over such resources and
technologies; and through adequate funding. “
4 - “National Sovereignty over GR”
5 - “Protection of ATK”
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The ratification and thereby enforcement
of the CBD aligned a State’s right to protect its
natural resources and common law of peoples
on ATK with that of sovereign rights. According
to Berger (2009), negotiations involving the
juxtaposition of political issues and norms of
biological diversity creates a fierce opposition
between large companies and peoples with
ATK of GR. History has evidenced these large
companies’ long-term interests in gaining
access to GR for the purpose of research,
technological development, bioprospecting,
and biotechnology (with respect to research
and technological development for economic
pursuits). These histories also implicate a long
stance in the pursuance of legislation advocating
for minimal restrictions and legal requirements
seeking to forgo protected sovereign rights
for States wherein the biodiversity resides;
and thus, undermining the intended purpose
of the CBD (Taubman & Leistener 2008). The
higher developed countries support the current
system of intellectual property protection, the
Trade-Related Aspects of Intellectual Property
Rights System (TRIPS), an international treaty
created by the World Trade Organization (WTO)
in 1994. TRIPS (WTO 2005) seeks to protect and
monopolize the ownership and development
of new technologies and products, including
those from biodiversity accessed through
traditional knowledge. On the other hand, local
and indigenous communities, most of them
inhabitants of developing countries, rely on the
1992 CBD, which guarantees the sovereignty of
States that have GR, establishing principles of
fair sharing of benefits, GR and, consequently, the
recognition of their cultural and collective rights,
in addition to expanding their participation in
the management of biological diversity and
biotechnological products (Baylao & Bensusan
2000).
The geopolitical and socioeconomic
implications associated with the branding
of a country as being” highly developed”
are espoused in the international model
established by TRIPS. By design the treaty does
not encompass the aspects of sovereignty
protective, and managerial rights over one’s GR
of their biodiversity and the future technology
derived from such as originally prescribed in the
intent of the CBD.
An example of this is the concept of ATK,
as it does not fit the requirements for patents,
i.e.: novelty, inventive activity, application,
and descriptive sufficiency, therefore ATK
as industrial property does not meet the
formal requirements of modern scientific and
technological knowledge, and, thus, forfeits
any sovereign rights for being considered as
protected knowledge (Braithwaite & Drahos
2000). Such is the case for Brazil, which in
1988, that is, before the appearance of the CBD,
the Constitution of the Federative Republic of
Brazil (CF/88) (Brazil 1988) already recognized
the importance of the genetic patrimony, so
much so that it dedicated specific foresight to
the chapter on the environment. Article no. 225,
paragraph 1, item II, establishes that it is the
Government’s responsibility to “preserve the
diversity and integrity of the country’s general
resources and oversee entities dedicated to the
research and manipulation of genetic material”
(Brazil 1988). However, it was only through
Provisional Act (PA) no. 2.186-16 / 2001 (Brazil
2001a), later regulated by Decrees no. 3,945 / 2001
(Brazil 2001b) and 4,946 / 2003 (Brazil 2003a),
that Brazil began regulating access to the GR of
Brazilian biodiversity and its ATK. The protective
measure was regulated through the granting
of authorizations by the presiding government
agency after the following conditions had been
met: a detailed description of the research
project and the proof of a prior consent granted
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by the community in question. In fact, PA No.
2,186-16 / 2001 was abruptly ended after a
leonine agreement signed between the Social
Organization of the Brazilian Association for
the Sustainable Use of Amazonian Biodiversity
(Bioamazonia) and the Swiss pharmaceutical
company Novartis, in which Novartis was given
exclusive access to the biodiversity of germplasm
in the form of strains of microorganisms and
plants. In this agreement, the Swiss company
was allowed to export live genetic material from
the Amazon to the outside, on a large scale, for
the manufacture of medicines, thus damaging
the public interest. Furthermore, we should
not forget that PA 2,186-16/2001 was criticized
because it did not encourage companies to
invest in Research and Development (R & D) due
to the rigid and time-consuming bureaucracy
that demanded high transaction costs with
economic exploitation. The provisions set-forth
by the PA made it difficult for researchers to
follow, thus provoking many into illegal activities
resulting in heavy fines and the abandonment
of research (Gilbert 2010). Due to the regular
desertion of research projects, Brazil is at
risk to lose its ability to generate knowledge,
new technologies and new products based on
biodiversity, ultimately harming all the actors
involved (Melo 2015). Since 2001, literature points
to growing international interest in biodiversity
and in the ATK to it, based on the increased
economic potential and biotechnological
outcomes associated with the intrinsic value
of GR (Capobianco et al. 2001). Bioprospecting
activity and the collection of biological material
and access to its GR are directly involved in the
search for new compounds for the development
of new pharmaceutical, chemical and food
products; moreover, the underlying motive
of these activities can result in commercial
exploitation (Bensusan 2005, Oberthür &
Rosendal 2013). In the advent of the law 13,123,
dated May 20, 2015, effective November 20, 2015
(Brazil 2015a) and repealing PA 2,186-16 / 2001
(Brazil 2001a), other significant changes were
determined, as the regulation of paragraph 2
of paragraph 10 and article 225, paragraph 4,
of the CF/88 (Brazil 1988), article 1, article 8 (j),
article 10 (c), article 15 and article 16 (3) and (4),
all of the CBD, promulgated by Decree no. 2,519,
dated March 16, 1998 (Brazil 1998); and, further,
it disposes on:
1 - Access to GR of the country (including
domesticated species, varieties and locally
adapted breeds or creatures and introduced
species that form spontaneous populations,
besides microorganisms that have been isolated
in national territory, territorial sea, continental
shelf or exclusive economic zone).
2 - ATK to GR, of identifiable origin or not.
3 - Access to technology and technology
transfer.
4 - Exploration of the finished product or
reproductive material from GR or ATK.
5 - The consignment to the exterior of part
or all of organisms, alive or dead, destined to
the GR.
6 - Implementation of International treaties
on GRs and ATK.
7 - Benefit sharing for the conservation and
sustainable use of biodiversity. According to
the new law, the Genetic Heritage Management
Council (CGEN) has the normative, deliberative,
advisory and appeal functions, being constituted
in 60% by representatives of public bodies and
entities of the public administration and 40%
by representatives of the partnerships among
business, academic, indigenous populations,
traditional communities, and traditional
farmers. Law 13,123/15 brought new advances
in bureaucracy in research, thus reducing the
long waiting time that led to the processing of
applications, which in some instances persisted
for more than two years, to obtain authorization
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for research. The request for authorization, a
requirement of revoked PA 2.186-16 / 2001 was
replaced by a compulsory registration with
the National Genetic Heritage and Associated
Traditional Knowledge Management System
(SISGEN), in the effort of preventing scientists
from being accused of biopiracy (da Silva
2017, da Silva & Oliveira 2018). The new law
represents a revolt against the revoked PA by
adopting modern and simplified procedures
to foster research and leverage technological
innovation; ultimately generating benefits for
society as a whole. This new law has faced
harsh criticism from various segments of society
from the academic and legal sector (da Silva &
Oliveira 2018). Apart from the severe budgetary
constraints that have been affecting science
in Brazil, the new legal framework regarding
access to GR and ATK still generates a great
deal of distrust and legal insecurity for the
various actors involved. In retrospect, many
statements and concerns cited in recent articles
largely denote a dearth knowledge of law 13,123
/ 2015 (da Silva 2017). The new legislation
created mechanisms for guaranteeing social
and environmental rights including the
recognition of the right to intellectual and
immaterial property of traditional peoples and
communities. The aforementioned conditions
are most favorable for access to GR for scientific
and technological development to have full
prosperity in a mega-diverse country like Brazil
(Smith & Plagnol 2016). Furthermore, redressing
the previous errors which led researchers to
engaging in illegal activities, the assessing of
hefty fines, and the eventual abandonment of
research projects was the creation of Regulatory
Decree 8.772 / 2016 (Brazil 2016), which provides
better vehicles of intervention for scientists and
researchers. In this context to this, GR and ATK
Management Committees were set up within
public institutions of education and research,
such as the Commission of the Federal Rural
University of Rio de Janeiro (UFRRJ), the Genetic
Patrimony Commission of the State University
of Campinas (PATGen) and the Committee of
FIOCRUZ.
MATERIALS AND METHODS
Among others, UFFGEN (http://www.uffgen.uff.
br) acts as an interdisciplinary collegiate of an
advisory nature, exercising public functions and
was created to contribute to the development
of activities related to access to GR and ATK
and to guide towards compliance with preestablished rules and laws by regulatory units.
The Committee’s activities are guided by the
relevant rules and procedures, especially
those issued by the CGEN of the Ministry of the
Environment and include a set of guidelines
for researchers, teachers, managers and the
scientific community, playing a consultative
and disseminating role, clarifying doubts
and taking information about the subject in
question to the scientific community in order
to make it knowledgeable about the matter,
which involves other actors, such as teachers,
lawyers, as well as researchers of the health
area, in a multidisciplinary way facilitating the
exchange of dialogue and knowledge. In this
work, the members of UFFGEN, and collaborators
performed a critical reflection on the new law,
helping Brazilian researchers with information
necessary to understand the changes made
by the new legislation, especially in the field
of Biotechnology associated with Brazilian
Biodiversity.
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RESULTS AND DISCUSSION
About the biodiversity law nº 13,123/2015
Subject to criticism and negative positions by
the scientific community and other sectors of
interest, Brazilian biodiversity law still raises
doubts about its efficiency, especially with
regard to the clarifications necessary for its
interpretation and its repercussions into the
academic world. There are so many questions,
especially, in the academic area such as: “Who
is interested in this law?”, “What benefit can
this law generate?”, “What its essential purpose
is?” For some the law leads to completely loss
of biodiversity control by the country and also
the loss of competitiveness in the area of
Biotechnology. Buckup (2018) considered that
the protection of Brazilian biodiversity should
encourage research on genetic patrimony so
that Brazil can act with sovereignty over its
biodiversity: “Imposing limitations on national
research is to subject the country to subservience
to other nations that do not adopt these types of
restrictions at all. The idea that there is a need to
control access to establish a market reserve for
biodiversity is as misleading as the reservation
of the computer market created in Brazil in the
last century “. On the other hand, proponents
of the law argue that it interests Brazil as
a megadiverse country and because of the use
of the biodiversity of other countries. Brazil,
along with another 104 countries plus the
European Union signatory, is signatory to the
Nagoya Protocol, which is the international
agreement that regulates “Access to GR and
the fair and equitable sharing of benefits arising
from their use” (Access and Benefit Sharing) (ABS), i.e., “establishes standards and guidelines
for the regulation of research and relations
between the country provider of GR and ATK
and who will use them, covering points such as
the sharing of benefits, payment of royalties,
establishment of joint ventures , right to
technology transfer and training (da Silva
2019). Thus, with the new law, Brazil has left
behind old customs and concepts about the
exploitation and distribution of benefits over
traditional products and knowledge derived
from cultural and environmental heritage (see
the section: reflections on the provisions of the
law on the protection of ATK to GR). Therefore,
as previously stated by Andrade (2013) about
a law that could guarantee a fair protection to
those who hold traditional knowledge as well
as more effectively and legally facing biopiracy,
current legislation has brought advances as
compared to the previous however, adjustments
are still needed, especially in the case for
research without commercial purposes. The new
law also emphasizes the importance of peer
review amongst researchers for the purpose of
critiquing and providing suggestions using the
CGEN Sectorial Chamber of the Academy, such
an adequate and legitimate space for these
discussions and proposals (da Silva & Oliveira
2018). The Chamber is made up of members
representing the academy including the Brazilian
Botanic Society (SBB), Brazilian Society of
Microbiology (SBM), Brazilian Society of Zoology
(SBZ), Brazilian Anthropology Association (ABA),
specialists in biotechnology and metagenomics
as well as CGEN advisers including the Brazilian
Society for the Advancement of Science (SBPC),
Ministry of Science, Technology, Innovation
and Communications (MCTIC) and Ministry of
Environment (MMA).
The access to SISGEN
Created by Decree no. 8772/2016 that regulates
the Law of Biodiversity no. 13.123 / 2015, the
SISGEN is an electronic system maintained
and provided by CGEN’s Executive Secretariat,
serving to assist the user in registering access to
the GR or ATK as well as sending or submitting
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samples containing GR, notifying finished
product or reproductive material, applying
for the authorization to access GR or ATK,
requesting accreditation from institutions that
maintain ex situ collections that contain samples
of GR, and to obtain certificates and documents
attesting the regularity of access. According to
the Ordinance SECEX / CGEN # 1 of 3 October
2017 (Brazil 2017), the SISGEN was implemented
and made available from the day November
6, 2017, at the website: <htpp: //sisgen.gov.
br/ pages / login .asp>, and the regularization
of all projects should be carried out until
November 5, 2018. However, this registration
procedure has been subject to harsh criticism
since it did not respond and still does not meet
the user’s satisfaction as to its operability,
nor did it properly consider some areas of
research such as molecular phylogeny, which
involves many different species; collections,
that demands great problem of exchange with
foreign institutions and farming covered by the
law, which led to the extension of deadlines for
the regularization of the projects to access GR
and/or ATK.
Legal aspects of law 13,123/ 2015
In accordance with the Nucleus of Studies and
Research of Brazilian Senate (Brazil 2015b) which
disposes and comments on the provisions of
the new law that may be questioned as to its
legality and constitutionality, we can highlight
some embarrassing points from the legal point
of view.
From the use of the term “indigenous
population”
According to the Constitution of the
Federative Republic of Brazil (Brazil 1988), the
expressions “populations”, “communities” and
“groups” are those established in the infraconstitutional text. However, after more than
twenty years of discussion regarding the
condition of the indigenous people of Brazil, there
was a technical and academic understanding
that the correct term was to designate these
groups as “peoples” thus recognizing the ethnic
and cultural identity of these groups beyond
that which is autonomous regarding the subject
of collective rights, and with the rejection of
attributing said group’s wealth of knowledge and
understanding to a universal principle and/or
idea. The problem in designating these groups
as “nations” is the strong political connotation
that this term reinforces a homogeneous
identity among said peoples and therefore
contradicts the already accepted anthropological
understanding affirming Brazil as a multi-ethnic
and plurinational State. (Schiel & Smith 2002)
As a signatory to Convention no. 169 of
the International Labor Organization (ILO), the
Convention on Indigenous and Tribal Peoples
promulgated by Decree no. 5,051 (Brazil 2004),
ratified the understanding that standardizes the
treatment of indigenous peoples as “peoples”
and that this nomenclature is adopted by
Brazilian legal system. In addition to the
Convention no. 169 of the ILO, there is the United
Nations Declaration on the Rights of Indigenous
Peoples, adopted by General Assembly on 13
September 2007 (ILO 1989, UNO 2007), which
confirms and uses the term “indigenous peoples”
in respect for the rights of those living under
their own ways of social organization, customs,
and traditions, strengthening the recognition of
their autonomy and not independence.
The legal nature of the benefit allocation to
the National Fund for the Benefit Division
(FNRB).
Law 13,123 of 2015 (Brazil 2015a) provides
for two types of benefit sharing: monetary or
non-monetary (art.19). The monetary allocation
may be: a) optional (art.19, §1), when there is
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economic exploration resulting from access
to the GR; and b) mandatory (article 23 and
§ 2 of article 24), when there is economic
exploration originated through access to the
identifiable and non-identifiable ATK. In such
cases, the proceeds from the sale of the finished
reproductive material from national GR and/
or ATK that garner a return of 0.1% to 1% (one
percent) of net income shall be deposited in
a public fund, FRNB. Microenterprises, small
businesses, individual microentrepreneurs,
traditional farmers and their cooperatives
with annual revenues equal to or less than
those established in relevant legislation will
be excluded from the obligation to distribute
benefits. In addition, the intermediate product
used in the production chain is also exempt from
the obligation to share benefits. In the present
case, it is important to note that, according to the
legal understanding of the country, the question
of revenues earned on behalf of the public
authority, in this case, the amounts received
as benefits-sharing, can generate controversies
in view of the need to define which legal
category benefit sharing fits. It is understood
that public revenue can be classified into two
species according to the doctrine of financial
law: originating revenues and derived revenues,
both based on law no. 4.320, dated March 17,
1964 (Brazil 1964a). According to this doctrine,
the originating revenues are those that originate
in the State’s assets (assets revenues) or in the
profitable exploitation of these assets by the
State (business revenues). That is, the revenues
indicated above come from the jus gestionis,
when the State acts in the same way as
individuals. In turn, derived revenues are derived
from the manifestation of jus imperii, from the
tax authority of the State. Here the collections
are the result of coercive acts by means of legal
constraint of the patrimony or the income of
the private individuals, as is the case of taxes
and fines. By making a brief interpretation of
the bill that was forwarded to Congress by the
Executive Branch and which culminated in the
law 13,123/2015 (Brazil 2015a), one can state
that what was intended was the creation of a
model of collection of resources in the modality
of original revenue, however, without specifying
in the project, expressly, the definition of
the taxable species, the generating fact,
the calculation basis for taxpayers, guidelines
for requirements and legal support for the
creation of a tax.
From the point of view of financial law
no. 4,320, of 1964 (Brazil 1964a) in its article 9,
defines tax as:
Tax is derived revenue created by public law
entities, including taxes, fees, and contributions
in accordance with the constitution and laws
in force in financial matters, and its product
is allocated to the cost of general or specific
activities carried out by these entities.
From the point of view of tax law, the concept
of tax is provided in the National Tax Code in the
following terms:
Tax is any compulsory pecuniary benefit,
in money or whose value can be expressed in
it, which does not constitute sanction of an
unlawful act, established by law, and charged by
administrative activity and fully bound.
In order to be able to identify, in particular,
the legal nature of the tax imposed by the
Federal law 13.123 / 2015, when it is part, on
the receipt of amounts due to access to the GR
and/or ATK, it is necessary to stick to the model
in the old PA nº 2.186-16 of August 23, 2001 in
its Contract of Utilization of GR and Benefit
Sharing (CURB), where such revenues would be
classified as originating. In that PA, the two types
of monetary benefits, by way of benefit sharing,
derived from the profit sharing and the payment
of royalties (items I and II of the PA article).
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Law No. 4,506, dated November 30, 1964
(Brazil 1964b), classifies as royalties the following
revenues:
Art.22. The income of any kind arising from
the use, enjoyment, exploitation of rights, will
be classified as “royalties”, such as:
a) the right to harvest or extract plant
resources, including forestry.
b) the right to research and extract mineral
resources.
c) use or exploitation of inventions,
manufacturing processes and formulas, and
trademarks of industry and commerce.
d) exploitation of copyright, except when
perceived by the author or creator of the
property or work.
e) Single paragraph: Interest on late payment
and any other compensation for late
payment of the royalties shall accompany
the latter’s classification.
What was intended by the new legal
framework with law 13,123 / 2015 (Brazil 2015a)
regarding the receipt of amounts as benefitsharing was similar to the model adopted
in the former PA, where the payment of a
percentage of the annual net revenue earned
due to the exploitation of finished product or of
reproductive material resulting from access to
GR and / or ATK.
In this case, it is possible to assume from
the point of view of financial law that the GR is
well publicly owned, thus recognizing its legal
adequacy of the benefit sharing provided for in
law 13,123 / 2015. Therefore, it is concluded that
the identification of the original revenue will
always depend on whether the public revenue
is derived from the state equity or from the
exploitation of that equity. On the other hand,
they will be classified as derived revenue, in
this case, taxing those that are not derived from
the access to the state patrimony. As stated in
the CF/88 and law 13,123 / 2015 (Brazil 2015a),
authorize the controversial belief that GR is a
public good. In the environmental part of its
article 225 of CF / 88, states that the environment
is for the common use of the people, while item
I of article 1 of law 13,123 / 2015 establishes that
the GR has the same nature legal basis. The new
legal framework states the following:
• Art.1º. This law provides for assets, rights
and obligations relating to:
• I - the access to the GR of the country and
of common use found in situ, including
domesticated species and spontaneous
populations, or kept in ex situ conditions,
provided that found in situ within the
national territory, the platform the
territorial sea and the exclusive economic
zone.
As for the classical subdivision of goods
in public or private, the basis of article 99 of
the Civil Code of 2002 follows, which reads as
follows:
• Art. 99. They are public goods:
• I - those of common use of the people,
such as rivers, seas, roads, streets, and
squares.
• II - those of special use, such as buildings
or land intended for the service or
establishment of the federal, state,
territorial or municipal administration,
including those of its local authorities.
• III - the proprietary, which constitute the
patrimony of legal entities under public
law, as an object of personal or real right
of each of these entities.
In this way it can be deduced that the
GR is a public good (in the subspecies, well
of common use of the town) and the State,
therefore, is authorized to demand by means
of legal prediction, the payment of value
due to the economic exploitation of product
derived from access to genetic information
through royalties which is a form of original
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revenue. In disagreement with law 13,123 / 2015
(Brazil 2015a) and also with CF / 88 (Brazil 1988)
that defines GR as a public good, the doctrine of
environmental law supports a different concept
for this definition, arguing that GR would be
classified in a third genus of goods, distinct
from public goods and private goods, that is,
GR would be called an environmental good. This
trend is defended by some jurists, such as Celso
Pacheco Fiorillo: “In verifying civil law, we note
that the basic powers of traditional property law
of the nineteenth century are understood by the
right to use, enjoy and dispose of the good. In
turn, the Brazilian Federal Constitution of 1988
(Brazil 1988) innovates the ordering, highlighting
of the environmental good some of these rights
and protecting assets that are not susceptible of
appropriation, either by the individual or by the
legal entity. In fact, the Constitution formulated
revolutionary innovation in the sense of creating
a third kind of good, which, due to its legal nature,
is not confused with public goods, much less with
private ones (Fiorillo 2019). The aforementioned
jurist even maintains the unconstitutionality of
item I of article 99 of the Civil Code, (Brazil 2002),
removing the characterization of environmental
goods as public goods, in the following terms:
“ Thus, as already stated in previous editions of
our course on Brazilian environmental law, we
reiterate the statement that not only is article
66, I of the Civil Code of 1916 (Brazil 1916), not
fully accepted by the Federal Constitution, and
article 99.1 of the Civil Code of 2002 is clearly
unconstitutional. The examples of common use
goods mentioned in the civil subsystem have
their legal definition specifically set out in
constitutional (Arts. 182, 183 and 225) and infra
constitutional environmental standards (rivers
and seas as environmental resources in the
natural environment as defined in the law as well
as roads, squares and streets as environmental
resources of the artificial environment defined
in laws 9,503 / 97 (Brazil 1997b) and 10,257 / 2001,
(Brazil 2001c). If this is the understanding, in
which the conclusion of the environmental law
doctrine prevails, even in the light of the literality
of item I of article 1 of law 13,123 / 2015, the legal
nature of the revenue from the distribution
of benefits to FNRB may be interpreted as
other way. In other words, by excluding public
ownership of the GR, the tax character of these
revenues would then be set, and, lastly, derived
in nature. Surely, it would be necessary to define
which kind of tax would have been created by
law 13,123 of 2015 and whether it would have a
constitutional basis for the creation of a new
tax. However, before mentioning the possible
tax nature of the benefit-sharing, the legal
possibility of qualifying the GR as a Union good
can be gauged by detailing the reading of article
20 of CF / 88, which describes what is owned of
the federative body.
• Art.20. They are Federal Union goods:
• I - the ones that currently belong to the
Union and those that are to be attributed
to it.
• II - the vacant lands indispensable for
the defense of borders, fortifications and
military constructions, the federal means
of communication and environmental
preservation, as defined by law.
• III - lakes, rivers, and any watercourses on
land in its domain, or which cover more
than one State, serve as boundaries with
other countries, or extend to or from
foreign territory, as well as marginal lands
and beaches fluvial.
• IV - the river and lake islands in the
border areas with other countries; the sea
beaches; the oceanic and coastal islands,
excluded from these, those that contain
the headquarters of municipalities,
except those areas affected to the public
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service and the federal environmental
unit, and those referred to in art. 26, II.
• V - the natural resources of the continental
shelf and the exclusive economic zone.
• VI - the territorial sea.
• VII - the lands of the navy and its
additions.
• VIII - hydraulic power potentials.
• IX - the mineral resources, including
subsoil.
• X- the underground natural cavities and
the archaeological and prehistoric sites.
• XI - lands traditionally occupied by
Indians.
In analyzing item I of the provision,
evidences other assets belonging to the Union,
while other assets not found in the law may be
attributed to it. Therefore, when considering GR
as a public good, ownership would be exclusive
to the Union. The tributary species are divided
into taxes, rates, improvement contributions,
special contributions and compulsory loans.
Considering the characteristics presented in
the law one can conclude that tax revenues as
a bioproduct of GR are a contribution before
the linkage of the product collected identified
with or a specific purpose. Linking is one of the
most characteristic traits of the contributions. In
the case of the Biodiversity Law, the correlated
tax contribution appears to conform with those
prescribed and authorized by CF / 88 in its article
149 and considered by the Brazilian Federal
Supreme Court as constitutional by means of an
ordinary law, the Contribution of Intervention in
the Economic Domain (CIDE - royalties), by way
that the Union has the exclusive competence
to levy this form of taxation. However, although
there is no problem in recognizing that the new
legal framework created a CIDE, from the legal
perspective, the tax legislation is ill-conceived by
its lack of necessary elements, more specifically
related to the legal text for this purpose, since
the tax elements are not explicitly stated in the
legal text, namely: aspects (active and passive
subject) and quantitative (basis of calculation
and percentual). This paper presents the results
of the study while providing basic requirements
for the creation of a tax in line with CF / 88
that presupposes all aspects mentioned in the
text, although not expressly stated. Thus, for all
the above reasons, it is felt that the rule to be
followed is from the point of view of financial
law while recognizes that GR is owned by the
Union. Consequently, it can be seen that the
classification of GR that generated revenues
should be treated as values originating from the
deposits by the economic agents as a result of
the economic exploitation derived from access
to GR. Thus, the assertion of GR as a Union
owned good would remove the tax character of
the revenue and alleviate problems with respect
to constitutionality and the jurisdiction of the
adopted model.
The legal nature of the allocation of benefits
intended as a result of the economic
exploitation of the ATK.
The controversy generated by the economic
exploitation of ATK, arises from the benefits and
amounts received as a result of said activities.
Law No. 13,123, of 2015 (Brazil 2015), in article 2,
item II, provides that the ATK is an information
or practice of indigenous population, traditional
community or traditional farmer on the direct or
indirect properties or uses associated with the GR
(Smith & Fausto 2016). Therefore, it is possible to
verify with this understanding that the property
in question belongs to the communities and
people and not to the State. This discussion
would lead to the same rules as the prevailing
hypothesis of this understanding that
ownership of the ATK belongs to communities
and individuals, and therefore, derived revenue,
would not be exempt from the aforementioned
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tax rules and analysis. no escape from the tax
rules that would be analyzed under the terms
described above. According to CF/88 and the
National Tax Code, GR is the identification code
for all elements in the tax incidence matrix rule,
while having this uniform code the law allows
for adequate capture of the unique derivatives
from each element (Brazil 1966). However, what
is best concluded here is the understanding
from the financial point of view, also with the
positioning of the doctrine that the ATK is in the
public domain even though the State recognizes
the rights of the ATK providers and derives
benefits as a result the economic exploitation,
by third parties of finished product or of
reproductive material. The other orientation - to
which we are affiliated - intends to create a sui
generis legal regime, that is, totally different
from the patent system, both from a conceptual
and an evaluative point of view. This guidance is
based on the fact that the entire patent system,
which protects intellectual property rights,
protects the so-called “new knowledge” as being
individually produced and not the product of ATK
knowledge generated collectively and informally
and transmitted orally from one generation to
another. These are considered, within the current
system, as belonging to the public domain, and
without any patent protection (Santilli 2005a, b).
Reflections on the provisions of the law on the
protection of ATK to GR
Article 8:
As its core, the article 8 clearly defines that the
scope for understanding that the GR in question
belongs to indigenous peoples, traditional
communities and traditional farmers is clear the
suggestion proposed by the Nucleus of Studies
and Research of Brazilian Senate (Brazil 2015b)
makes the wording clearer by stating: “The rights
of indigenous peoples, traditional communities
and traditional and family farmers over ATK to
GR are protected by this law.”
Art. 9: Prior Informed Consent
The paragraph 1 of the article 9 guarantees
indigenous peoples, traditional communities,
and farmers’ autonomy consenting to access
to ATK associated with GR, however, establishes
that the procedural manner of access is not only
authorized by CGEN, but must also be heard by
the designated indigenous governing body. The
important thing here is to clearly establish the
mandatory listening of the indigenous agency to
prevent the asymmetry of information between
the many indigenous peoples and the parties
interested in the indigenous ATK as an effort to
decrease the possibilities of leonine contracts.
article 9, paragraph 3, provides that the ATK is
a non-identifiable origin whose access to the
traditional local or creole variety or the locally
adapted or creole breed has taken place,
thereby removing the legitimate rights of the
holders of such knowledge. It is of the utmost
importance to deepen the discussion with the
participation of all concerned about possible
distortions that this device may cause. By the
wording of the device, it is enough clear to say
that any interested party who has access to
copies of these components of GR can avoid the
obligation to respect and compensate the ATK
holders.
Regarding the ATK of non-identifiable
origin defined in article 2, item III, there is the
possibility that the knowledge may be linked
to a specific source in the future due to better
studies, technical review or dispute resolution
on origin or authorship. In this way, there was
a lack of mechanisms in the law to compensate
the holder of this knowledge or any contingency
reserve for this case in the FNRB.
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Article 10, item V - On the Law of Cultivars
(Law No. 9,456, of 1997, (Brazil 1997a) and the Law
of Seeds (Law No. 10.711, of 2003), Brazil 2003b)
The normative content of the new law
regarding the rights that indigenous peoples,
traditional communities, and traditional farmers
have to use and freely sell their products that
contain ATK is already born fragile. According to
the provisions of law 13,123, of 2015, the rights of
these peoples over plant GR are limited since
they are bound by the definition established by
the Ministry of Agriculture, Livestock and Supply
(MAPA) - which establish the Law of Cultivars and
Seeds - without recognizing CGEN’s competence
on the issue of ATK.
The current criticism is that the identification
of creole seeds by MAPA has been carried out
with discretionary and not very precise criteria
from the point of view of scientific point of view.
Going in the opposite direction, where new
scientific criteria based on the use of molecular
markers for the definition and identification
of locally adapted creole seeds and races is
what accompanies modern genetics today.
Since native seeds provide intrinsic ATK, this
assumption directly affects the rights of holders
to benefit from the benefits generated from
the GR of agro-biodiversity. It is important to
point out that law no. 10,711 of August 5, 2003
(Seed Law) (Brazil 2003b) in its article 2, item
XVI, defines a variety of creole different from
law 13,123 / 2015, providing that this definition
is at the discretion of MAPA. This discretion
has the potential to generate ambiguity in the
interpretation of what it means to be creole,
and thus affecting the benefits derived from this
classification.
Article 24: Benefit Sharing Among Other
Holders of ATK
As provided by law, the distribution of benefits
may be mandatory and not mandatory, however,
article 24 provides that in addition to sharing
benefits with the ATK provider, sharing with
other holders of such knowledge will also
be mandatory through the FNRB. However,
there may be inequality and unbalanced with
the FNRB if transfer of technology, technical
assistance, human resources training, and
product distribution are established as a form
of benefit sharing.
Absence of Prior Consultation of Indigenous
Peoples
According to the Convention no 169 - ILO
promulgated in Brazil by Decree No. 5,051, of
April 19, 2004, indigenous peoples must be
consulted in advance to express their views on
any laws or regulations that may affect their
rights. Regarding the procedures that resulted
in law 13,123 / 2015, it did not count on the
participation of the indigenous peoples or the
federal indigenous body satisfactorily (Smith et
al. 2006). Therefore, the law is in direct affront to
the provision of this Convention and may hold
the federal government accountable nationally
and internationally. In short, with the advent
of the new law, the benefit-sharing model
was defined in monetary and non-monetary
modality, which simplified and established
clearer rules for its effectiveness. The previous
rules established in PA nº 2.186-16 of 2001
inhibited the access and made it almost
impossible to materialize the distribution of
benefits due to the difficulties of identifying
the beneficiaries and, consequently, of reaching
an agreement on values to be distributed. In
addition, each stage of the innovation process
was subject to allocation. The extinction of the
Contract of Utilization of GR and Benefit Sharing
(CURB), which was the procedure adopted by PA
nº 2.186-16 (Brazil 2001a), and that, frustrated
in advance any initiative of access instead of
generating a high cost of transaction for the
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authorization of CURB, has been replaced. In its
place was created the ABS whose requirement
is derived only for the exploration of finished
product or reproductive material and at a
time after all innovation activity has ceased.
In this way, it facilitated the emergence of
innovations and exempted the process of
licensing and transfer of technology involving
university patents. The discussion here arises
at a time when, even with the advancement
and simplification of procedures to be adopted
for an ABS that excluded the manufacturers of
intermediary products. According to article 17,
paragraph 5, I, allowed for the cascading effect
in the avoidance and exemption from benefit
payments and the distribution of benefits to
intermediate links of the production chain,
including large company producing inputs from
the originating GR and ATK and its main buyer’s
microenterprises, small business and individual
microentrepreneurs.
Another important concern that has
been discussed by jurists is the requirement
embedded in article 17 that the GR or ATK
component is one of the key elements of value
adding of the finished product for benefitsharing. Subsection XVIII of article 2 states that
such elements are those “whose presence in the
finished product is decisive for the existence
of the functional characteristics or for the
formation of the marketing appeal”. Such a
definition is not consistent with the reality of
the facts since it is subjective and may motivate
numerous litigations because of the difficult
verification of these determinants. A clear
example of this contention lies in the fact that
only the manufacturer has a real idea of the
weight of each component in the definition of
the value of its product and does not disclose
that information for reasons of secrecy or
intellectual property rights. The most vulnerable
will bear the legal burden of proving that the
element in a possible judicial dispute is decisive
for the existence of functional characteristics
or for the formation of the marketing appeal of
the finished product. From this it can be seen
that there is a non-negligible risk that many
companies will not comply with the obligation to
distribute benefits on the basis of the argument
of the GR component or the ATK present in
the finished product is not among the main
elements of value added. Under the new legal
framework, the Union will establish by decree
the List of Classification of Benefit Sharing, based
on the Mercosul Common Nomenclature (MCN).
In the original draft submitted to the House of
Representatives, a “positive list” was proposed
in which the distribution of benefits of finished
products would only occur exclusively on the
products provided for the list. This list was
jointly defined by the Ministries of Environment,
Ministry of Development, Industry and Foreign
Trade and Ministries of Science and Technology
and Innovation. However, although it was drafted
together, it did not make it clear what kind of list
it would be. It should be emphasized here that,
if it is a positive list, until it is edited, no product
will be eligible for benefit-sharing. The ones
that would be disadvantaged would be the right
holders of benefit-sharing rights, for example,
on cosmetic products that, as it happens, have
a short life cycle? On the other hand, innovative
products might not be on such a list. Actually,
what is really intended is a “negative list” i.e.,
exemption from benefit sharing, for example with
products considered essential and strategic by
the Union for public health innovative products
might not be on such a list.
For all of the above, the new legal framework
establishes that the ATK can be classified as
having an identifiable or unidentifiable origin,
making the rules simpler and clearer on the
distribution of benefits. Thus, the problem
created in the previous rule, PA No. 2186-16
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(Brazil 2001a), which was the need to identify all
ATK holders before concluding a benefit-sharing
contract, was overcome.
On the provisions dealing with matter
regulated by the CBD and the environmental
legislation
Law 13,123 (Brazil 2015a) regulates certain articles
of the CBD, promulgated by Decree No. 2,519
(Brazil 1998), as part of Brazil’s commitment
to internalize CBD objectives, principles, and
guidelines through of its own legislation.
According to doctrinal and jurisprudential
understanding, the new regulatory framework is
the specific law that will have its preponderant
application to the CBD. Such a situation may
cause legal uncertainty regarding article 2 that,
in spite of establishing new concepts, it proposes
to consider the definitions contained in the CBD.
In the case of item I of article 2 of the law, for
example, defines GR as “information of genetic
origin of plant species, animals, microbial or
other species, including substances derived
from the metabolism of these living beings “.
The term “or species of a different nature”
may generate legal uncertainty and allow for
different interpretations to the detriment of
legislative technique and the second part to
include “substances” differs from the concept
of GR as “genetic information” since in the
CBD text, definitions of genetic and biological
resources, conceptualize genetic material as
“material of plant, animal, microbial or other
origin that contains functional units of heredity”.
Due to the ability of biotechnology to synthesize
assets from information available in a database,
regardless of the genetic material to complete
its process of technological development may
conclude that the concept of GR adopted in the
law is the most appropriate. More importantly
is the fact that with the current technological
development it is possible to obtain all the
necessary information from other types of
molecules, other than the hereditary ones, like
proteins and other metabolites. In addition,
information from genetic material should be
protected, since once accessed it could be
freely distributed, especially those associated
with the reading and sharing of genetic data.
Consequently, the genetic material would lose
importance to the user, causing harm to the
provider (Brazil 2015b, Santos et al. 2018).
Regarding the sample collection of GRs as
a triggering factor for the obligation to obtain
authorization or registration, this is not provided
for in the new law, since item VIII of article 2°
provides that access to the GR is considered the
research or technological development carried
out on a sample of GR and will be required
to register, authorize, or notify the competent
authority. In clause X of the same article, the
research is defined as the:
“Experimental or theoretical activity
carried out on genetic patrimony or ATK, as the
objective of producing new knowledge, through
a systematic process of knowledge construction
that generates and tests hypotheses and theories,
describes and interprets the fundamentals of
phenomena and facts observed.”
In this sense, article 3, when deciding
on the purposes of access such as research
or technological development, repeats the
very definition of access, which is precisely
research or technological development.
When conceptualizing access as research or
technological development, it may be assumed
that collection, an activity not regulated in
the law, is an inherent act of research. When
analyzing article 14 of the Law of Fauna (Brazil
1967) it establishes the possibility of granting
to scientist’s special license for the collection
of material destined for scientific purposes,
at any time. By not referring to the Law of
Fauna, any collection of material presupposes,
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today, the technical possibility of accessing
the GR. Therefore, it is recommended to insert
a new paragraph to article 14 of the Wildlife
Law, whose purpose would be to clarify that
“the collection referred to in caput does not
authorize access to GR, which will observe
specific legislation”. “It is important, for now,
to mention that paragraph 1 of article 14 of the
Wildlife Law authorizes foreign scientists to
obtain a license to collect material, through an
official scientific institution. However, the new
regulatory framework is closed in paragraph 1 of
article 11, access to GR by natural person foreign.
Therefore, when it appears that the collection
of material, when considered as part of the
research activity, can make the access to the
GR possible, though it is suggested by lawyers
and parties involved that the first paragraph
of article 14 of the Wildlife Law, since the
prohibitive or authorizing regime for the foreign
natural person should be symmetrical between
the laws. Another point worth mentioning
is the forecast, in article 13, items I and II, of
the requirement of prior consent of federal
agencies in situations involving access to the
GR or ATK in an area indispensable to national
security or in Brazilian jurisdictional waters, the
continental shelf and the exclusive economic
zone. In this case, there was an omission of the
law regarding the activities of GR and ATK in
conservation units that are regulated by law no.
9,985 (Brazil 2000). It should be specified in its
own device and for legal certainty, according to
the understanding of the Nucleus of Studies and
Research of the Legislative Consulting (Brazil
2015b) that the activities of access to the GR or
the ATK in conservation units will depend on the
prior authorization of the body responsible for
the administration of the unit and will be subject
to the conditions and restrictions established
by it, as well as those established by regulation.
Further analysis of the articles 8 and 44 of the
law
Regarding the final content of the provisions of
paragraph 2 of art. 8 of law 13,123 (Brazil 2015a):
paragraph 2: The ATK associated with to GR
referred to in this law is part of the Brazilian
cultural heritage and may be deposited in a
database, as provided by the CGEN or specific
legislation.
Here there is a conflict of jurisdiction, since
an act of the CGEN could not be equated with
specific legislation, nor could it deal with matter
reserved to the law or modify understanding
present in the current legislation. An act of
the CGEN is considered secondary normative act
of whose foundation is taken away of the laws to
which it would be subordinated and, indirectly
from the own Federal Constitution. On the basis
of that provision, acts of the CGEN could deal with
matters outside its jurisdiction and, until the
judiciary decided on possible abuses, those acts
would be presumed to be valid and therefore
infringing rights. Thus, a correct registration on
SISGEN seems to be nowadays the best way to
prevent legal troubles to Brazilian researchers
once they send any GR or ATK material to foreign.
Analysis of Art. 44
The criticism here is about the remission of civil
damages related to GR or ATK to rights of the
Union. There is loss of rights of the Brazilian
State when economic agents who failed to
comply with the current legislation have
benefited from the amnesty. There are estimates
that the Union would be assuming a loss of
revenue of nearly R$ 220 million. On the other
hand, it is argued as to the legality of the fines
imposed and that these would be ineffective
in the face of the low capacity of the State in
its collection and also because such collection
processes are uneconomical, above all, and
mainly, that a large portion of these fines were
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imposed on researchers of public institutions
and not biopirates. Thus, these important actors
would not benefit economically from the difficult
and long research work, provoking a negative
effect by discouraging the research process.
legislation. On the issue of GMOs, which should
also be regulated by the new legal framework,
there is a discussion on whether the Biodiversity
Law will overlap on the Biosafety Law.
Biodiversity law X Biosafety law
Impacts of the new legal framework on the
field of biotechnology
In article 4, the law provides for non-application
to human genetic patrimony but does not make
any reference to the application of the Biosafety
Law (Brazil 2005) that regulates items II, IV and
V of paragraph 1 of article. 225 of the Federal
Constitution and establishes safety standards
and mechanisms to supervise activities
involving genetically modified organisms (GMOs)
and their derivatives. In addition, it creates the
National Biosafety Council (CNBS), restructures
the National Technical Biosafety Commission
(CTNBio), provides for the National Biosafety
Policy (GNP) and repeals the former Law of
Biosafety (Brazil 1995). It is understood that the
revoked PA no 2.186-16 (Brazil 2001a) in its article
36 expressed clearly that its provisions would
not apply to the matter governed by the former
Biosafety Law. This same understanding was
adopted by the new framework excluding the
possibility of discussion on the application of
aspects related to biosafety and biotechnology.
With regard to legal certainty, the Nucleus
of Studies and Research of the Legislative
Consultancy speaks with assertive precision on
the theme: legal certainty derives from the fact
that the forecasts on access and research, for
example, are not uniform in both legislations. As
an example, an argument about tacit abrogation
of the future law with respect to the Biosafety
Law would be possible, with the aggravating fact
that the law on biodiversity is later. In addition,
the new legislation could prevail, even with the
understanding that the new legislation does
not intend to regulate that matter, generating
problems in the application of the new
The new legal framework (article 8 to 10) had
great impact in the areas of biotechnology
related to the environment, traditional
knowledge, and agriculture. As an example of
this is the regulamentation found in article
225 of CF/88 which was especially important in
the preservation of national biodiversity as it
regulated the access to GR and ATK. According
to article 9, the law guarantees that only the
results will be subject to laws which include
taxes and benefits sharing, not processes
involved in the research itself. In this compass,
the discussion about the biodiversity problem
in relation to the transition from an intensive
techno-economic paradigm in fossil energy
from natural resources to another based on
information and the growing use of science and
technology in the productive process, reveals,
in this context, the importance of advanced
biotechnologies as a mean to add value to
biodiversity in the globalized market, valuing not
the living organisms themselves, but the genetic
information contained therein. Information, as
said before, occupies an increasingly prominent
place in contemporary societies. The socalled new technologies comprise a series of
applications of scientific discoveries, whose main
objective is the development of an increasing
capacity of information refinement, as well as
its direct application in the productive process,
both in symbolic information through intelligent
communication and in microelectronics and
computer science, or through living matter
through genetic engineering, the basis of
advanced biotechnologies. In the case of
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biotechnologies, biological and genetic diversity
become a basic raw material for the advances
that have occurred in this area, transforming it
from mere natural resource into an information
resource. On the other hand, there is an
asymmetric spatial distribution of biogenetic
resources and scientific-technological resources
(Albagli 1998). While most of the biodiversity is
found in developing countries, the knowledge
that underlies modern biotechnologies is
located in advanced economies (Da Silva 2017,
Oliveira et al. 2017)
In this context, the control of strategic
information, as well as the techno-sciences that
add value to this information, becomes one of the
centers of dispute and conflict in the international
economic and political scenario. Such control
can be exercised both in the domain of access
to biodiversity resources and in the protection
of intellectual property rights, in modern
biotechnologies and in the ATK of local peoples.
Therefore, the discussion on biodiversity is no
longer an ecological or scientific-technological
issue to assume a geopolitical dimension, but
also that “the privatization of life are two facets
of this process. However, it can be verified that
biodiversity is invested with a double meaning:
as an essential element supporting life and
as a reservoir of future value. In general, the
concept of biotechnology may include any
technique which uses living organisms (or
parts of organisms) with the aim of producing
or modifying products; improvement of plants
or animals and discovery of microorganisms for
specific uses (Dahms 2004). It was in the
early 1970s, from the recombinant DNA
technique, that it became possible to transfer
genetic material between living organisms by
biochemical means that biotechnology came
to be denominated by two concepts: traditional
biotechnology and modern biotechnology.
The latter associated with the possibility of
obtaining products and substances through new
genetic techniques and not only coming from
the crossing of species found in nature. Today,
scientific advancements in biotechnology fields
motivate high hopes for disease prevention since
most of them come from genetic component as
well to increase the food supply in general,
besides to promising high economic gains with
the new products generated. From the linkage
of molecular, chemical, and genetic biology, the
possibility of not only unraveling the mysteries
of the genetic code but also of being able to
manipulate it has opened up, which makes the
twenty-first century a harbinger of new age,
the gene, or the scientific paradigm.
Impacts of the law on biotechnology with
regard to patents
The positive impacts in the framework of the
law on patents in Brazil, can be attributed to
the participation of the industrial sector in the
CGEN. Through their active participation, much
has been elaborated regarding the weighting
issue of inputs in the production process. This
contribution is imperative, especially regarding
the cosmetics sector among others that have
contributed to the positive effects resulting from
the new law. Consultants and experts were hired
to ensure that companies and their researchers
were duly monitored to join SISGEN in a timely
manner. These measures were taken as way to
better gauge the use of exemptions and fines
that were applied to those institutions and
some researchers, during the validation process
(Brazil 2001a), This newly adapted process
provided flexibility in the issuing of exemption
and fines to account for previous allowances of
activities that were no longer permitted in the
adaptation of the new law. These exemptions
from fines included prior acts committed by
companies and researchers that were done
without the authorization of the competent
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bodies to search GR and/or ATK. However, these
penalties that occur imposed to institutions and
researchers are, until now, sub judice, since due
to legal inconsistencies of the law itself, and
thus, the decisions still have not been possible
to be proclaimed. There are still many doubts
about the legality of collections and questions
of legal interpretations. The negative aspects
of the law can be attributed that even today
researchers and companies still feel insecure
on how the new law can be interpreted. Many
academics have defended and still defend the
thesis that the law did not benefit research and
that this would leave researchers in a vulnerable
state due to legal uncertainty and uncertainties
regarding the registration deadlines in SISGEN.
This sentiment has led many researchers to
abandon their studies with Brazilian products
including research using what can be considered
as cutting-edge Brazilian technology and
consequently damaging the national economy
and the country’s biodiversity. There is an
outcry that the flaws in the registration system
are sometimes incorrigible and in fifteen years
of drafting the law no specialized technical
assistance was hired to aid in the operation of
the new system that would effectively enable
the registration in SISGEN. In short, what is clear
today is that there is a more proactive attitude on
the part of companies to inform themselves and
to conform to the new law than the academic
sector that is still resistant to some aspects of
the law.
The Brazilian patent law no 9,279 (Brazil
1996), had been made early at a non-favorable
moment, and is considered by some specialists
to be very restrictive, because it did not
anticipate advances in biotechnology, because
of an industrial backwardness of the country
itself and, therefore, for not obtaining patent
possibilities. At the same time, Brazil has
the greatest biodiversity on the planet, 24%
according to the UN, and it is already known,
economists predict, that more than 70% of the
drugs that will serve humanity in the future will
come from this biodiversity. A primary example
of this is a drug currently being produced and
patented by the Swiss company NOVARTIS
for the cure of a degenerative disease, such
as family hypertrophy, will cost around R$
4 million. The question is: who can pay for
this treatment? The answer that biodiversity
and biotechnology can counter this onerous
demand is that its biotechnological products
have a particularly important bias in terms of
the equality of treatments and their availability
to the public. In the case of Brazil, due to a delay
in the technological industry, we do not have the
power to deposit patents on natural products,
technology, molecules, extracts, etc., since the
promotion and public policies focused on the
issue of innovation and technology are basically
in public health and education. Who will put
the biotech products on the market is not the
Brazilian industry, but the companies from the
most technologically advanced countries that
have the resources to invest in technology and
take the risks that the results can bring. In Brazil,
the money invested in technology is public, which
makes research even more difficult, since in the
developing countries public funds are directed
to other essential purposes such as education
and health as stated before and cannot take
risks. This time, it is easy to see that such
propositions and investments in science and
biotechnology, as well as the filing of patents on
products of Brazilian biodiversity, will be carried
out by companies located in technologically
developed countries (Angeli 2017). Here, it is
worth mentioning that living matter may be
subject to corporeal, public, or private property,
(e.g., through ownership over the outcome of
a harvest), and intellectual property, which is
exercised for a fixed term in accordance with
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LAW OF BRAZILIAN BIODIVERSITY AND BIOTECHNOLOGY
the legislation established in each territory,
according to general principles defined
internationally. Thus, patents have been granted
for technological innovations related to all or part
of living beings, be they microorganisms, plants,
or animals (processed by genetic engineering or
not), as well as for gens or part thereof, covering
products, their uses, and processes of obtaining
them. However, intellectual property rights over
living things or biological material derived from
these metabolic processes are related to the
information contained therein in the genes of
the organism and not in the organism itself,
other than the physical or bodily property of
a given species of animal or plant. In the case
of a pseudo-inventor granting intellectual
property rights over a living being or biological
material may affect access to it or some part of
it, as well as the use made of it, enabling the
exercise of monopoly rights, even if temporary,
on reproduction and commercialization of
the product, or the assignment of this right in
exchange for the receipt of royalties (Rabitz
2017, Williams et al. 2020). The first patent grant
for a living organism occurred in 1871 to Louis
Pasteur, France, for perfecting the brewing
process through a yeast free of pathogenic
germs. However, there are some who still
consider that the international legal framework
for granting patents for living organisms,
excluding man, comes from the US Supreme
Court decision in 1980, where the patentability
of microorganisms engineered to per se to
manufacture or composition of matter. Since
this initial milestone, there has been a great
growth in patent applications in the area of
genetic engineering worldwide, promoting, in a
certain way, the toughening and standardization
of mechanisms for the protection of intellectual
property rights. The current TRIPS agreement,
signed by the World Trade Organization (WTO), of
which Brazil is a signatory (Brazil 1994), is highly
comprehensive as regards the recognition of
intellectual property rights in the biological and
biotechnological areas.
Today different forms of legal protection of
intellectual property are used, such as patents
for DNA sequences, patents of microorganisms,
patents of cultivars and transgenic animals and
protection of cultivars and rights of breeders
(breeders who dedicate themselves to breeding
of a breed or herd). However, strong controversies
have been generated due to the current tendency
to establish mechanisms to protect intellectual
property on living beings or their components
(Rabitz 2017, Simmonds et al. 2020). The first
concerns the differentiation between a natural
living being and a biotechnological product,
or between a discovery and an invention new
gene product. There is a dominant current that
argues that biological and genetic engineering
research actually produces discoveries rather
than inventions because they only recombine
preexisting genetic materials or isolate
substances found in nature. Another major
difficulty in the application of intellectual property
laws in the biological and biotechnological
areas lies in the fulfillment of the requirement
of full description of the object of the patent,
in particular when describing all or part of a
living being, in relation to biotechnological
processes and products), thus compromising
the possibility of reproduction of the invention.
Another problematic aspect, associated with
the previous problem, refers to the frequent
disrespect to the requirement of industrial
application before a patent application in
biotechnology, which can lead to a monopoly on
genetic material essential to the advancement of
research and scientific knowledge. This problem
has been most recurrent in patent applications
for gene sequences. The scope and delimitation
of the patent object is also a controversial
point regarding the definition of which parts
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MARCELO FOLGOSI et al.
LAW OF BRAZILIAN BIODIVERSITY AND BIOTECHNOLOGY
of the physical structure of the gene must be
patented and about the scope of the granted
patent, since the same biotechnological process
can generate different products that can be
incorporated to many other products. Parallel to
these technical issues, the granting of patents
in the biological and biotechnological areas
involves other aspects of moral, political, and
economic order, which allows the mobilization
of different interest groups with different points
of view. In the face of the increasingly strategic
nature of new biotechnologies, the international
flow of information and knowledge in this area
tends to be under the political control of the
most advanced countries, scientifically and
technologically, to the detriment of developing
countries.
CONCLUSION
This review presented the antecedents and
innovations of law 13,123, of 2015, and its
Regulatory Decree no. 8772, of 2016, raising issues
that, in contrast to the various positive aspects
of previous legislation, such as the attempt to
protect the rights of traditional communities
and the regulation of benefit sharing resulting in
GR and ATK in order to put an end to biopiracy,
have endowed research and innovation in
biotechnology in Brazil for fifteen years. With
the advent of the new legal
framework, many
doubts still linger among the actors involved,
especially concerning procedures for registration
with SISGEN, which is still precarious, as well as
on the viability of encouraging R & D projects
and national research, In general terms, the
manipulation and exploitation of nature and its
resources, which initially served as a simple raw
material used in the construction of a material
structure for industrialized societies, now plays
a new role as a source for science experiments
and advanced technologies, leading to the
manufacture of sophisticated and high valueadded products in the world market. As
enlightened by Becker (1997): The new mode
of production redefines nature and societynature relations. On the one hand, it tends to
become independent of the natural resource
base by using less raw materials and energy,
but, on the other hand, it values the elements
of nature on another level through the use of
new technologies, especially biodiversity crucial
information for biotechnology - and water, as
a possible energy matrix. In other words, its
values nature as present or future realization
capital. With reference to the current globalized
scenario, it is known that the tendency towards
the private appropriation of information and
knowledge through increasingly restrictive legal
instruments in relation to the protection of
intellectual and industrial property becomes the
rule, since life itself and nature can be virtualized
into patentable microscopic fragments and will
certainly be the objects of privatization by large
economic conglomerates. Thus, what we have to
reflect in the present moment is not the diversity
of nature, or the life itself that has been valued.
What is at the heart of matters related to matter,
are the genetic particles, or the information
contained therein, which has strategic value
for advanced biotechnologies. It is impossible
to deny the importance and contribution that
the development of modern biotechnologies
brings to humanity. However, according to Cruz
(2018), the private appropriation of GR, even if
indirectly, protected by patent protection, may
restrict access to biogenetic resources and,
consequently, the benefits derived from their
use. In this course, the motto shall be the
responsibility of all actors involved with the new
regulatory framework of biodiversity as a whole
and the precise knowledge of the law and its
interpretation.
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LAW OF BRAZILIAN BIODIVERSITY AND BIOTECHNOLOGY
Acknowledgments
rd
BRAZIL. 1967. Law nº 5,197 January 3 . Diário Oficial da
The authors thank the Pró-Reitoria de Pós-Graduação,
Pesquisa e Inovação da Universidade Federal Fluminense
for the support to UFFGEN activities and Coordenação de
Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
and Conselho Nacional de Desenvolvimento Científico
e Tecnológico (CNPq) for the scholarships. The authors
also thank Denise Prescod (teacher at the American
School in Rio de Janeiro) by the extensive English
revision of the manuscript.
União, Brasília, DF, 5 Jan. 1967. Seção I, 1 p.
BRAZIL. 1988. Constituição da República Federativa do
Brazil, October 5th. Diário Oficial da União, Brasília, DF,
05 Out. 1988.
th
BRAZIL. 1994. Decree nº 1,355, December 30 . Diário Oficial
da União, Brasília, DF, 31 Dez. 1994. Seção I, 21394 p.
th
BRAZIL. 1995. Law nº 8,974, January 5 . Diário Oficial da
União, Brasília, DF, 6 Jan. 1995. Seção I, 337 p.
th
BRAZIL. 1996. Law nº 9,279, May 14 . Diário Oficial da
União, Brasília, DF, 15 Mai. 1995. Seção I, 8353 p.
REFERENCES
th
BRAZIL. 1997a. Law nº 9,456, April 25 . Diário Oficial da
ALBAGLI S. 1998. Da biodiversidade à biotecnologia: a
nova fronteira da informação. Ci Inf 27(1): 7-10.
ANDRADE RC. 2013. The genetic patrimony and biodiversity
União, Brasília, DF, 28 Abr. 1997. Seção I, 8241 p.
rd
BRAZIL. 1997b. Law nº 9,503, September 23 . Diário Oficial
da União, Brasília, DF, 24 Set. 1997. Seção I, 21201 p.
th
Emphasis on international forms of protection against
biopiracy. Rev Fac Dir UERJ 1: 23.
BRAZIL. 1998. Decree nº 2,519, March 16 . Diário Oficial da
ANGELI R. 2017. Propriedade Industrial em Biotecnologia.
BRAZIL. 2000. Law nº 9,985, July18 . Diário Oficial da
BAYLAO RS & BENSUSAN N . 2000. Conservação da
biodiversidade e populações tradicionais: um falso
dilema. Rev Fund Esc Sup Min Públ DF Terr 16: 161-180.
BRAZIL. 2001a. Provisional Measure nº 2,186-16, August
23rd. Diário Oficial da União, Brasília, DF, 24 Ago. 2001.
Seção I, 11 p.
BECKER BK . 1997. Novos rumos da política regional:
BRAZIL. 2001b. Decree nº 3,945, November 28 . Diário
Act Sci Thech 5(2): 1-4.
por um desenvolvimento sustentável da fronteira
amazônica. In: Becker BK and Miranda M (Eds), A
geografia política do desenvolvimento sustentável, Rio
de Janeiro: Editora UFRJ, Rio de Janeiro, Brazil, p. 421-443.
BENSUSAN N. 2005. Situação das unidades de conservação
na Amazônia Brazileira. Ciên & Amb 31: 65-77.
BERGER AGF. 2009. O conflito entre as normas de repartição
de benefícios do acesso aos recursos genéticos e o
sistema internacional de propriedade intelectual. Dir &
Dir 1: 1-15.
BRAITHWAITE J & DRAHOS P . 2000. Global Business
Regulation, 1st ed., New York: Cambridge University Press,
672 p.
st
BRAZIL. 1916. Law nº 3,071, January 1 . Diário Oficial da
União, Rio de Janeiro, DF, 5 Jan. 1916. Seção I, 133 p.
th
BRAZIL. 1964a. Law nº 4,320, March 17 . Diário Oficial da
União, Brasília, DF, 23 Mar. 1964. Seção I, 2745 p.
th
BRAZIL. 1964b. Law nº 4,506, November 30 . Diário Oficial
da União, Brasília, DF, 30 Nov. 1964. Seção I, 64 p.
th
BRAZIL. 1966. Law nº 5,172, October 27 . Diário Oficial da
União, Brasília, DF, 27 Out. 1966. Seção I, 12451 p.
União, Brasília, DF, 16 Mar. 1998. Seção I, 1 p.
th
União, Brasília, DF, 19 jul 2000. Seção I, 1 p.
th
Oficial da União, Brasília, DF, 3 Out. 2001. Seção I, 1 p.
th
BRAZIL. 2001c. Law nº 10,257, July 10 . Diário Oficial da
União, Brasília, DF, 11 Jul. 2001. Seção I, 1 p.
th
BRAZIL. 2002. Law nº 10,406, January 10 . Brazilian Civil
Code. Diário Oficial da União, Brasília, DF, 11 Jan. 2002.
Seção I, 1 p.
st
Brazil 2003a. Decree nº 4,946, December 31 . Diário Oficial
da União, Brasília, DF, 1 Set. 2004. Seção I, 1 p.
th
BRAZIL. 2003b. Law nº 10,711 August 6 . Diário Oficial da
União, Brasília, DF, 6 Ago. 2003. Seção I, 1 p.
th
BRAZIL. 2004. Decree nº 5,051, April 19 . Diário Oficial da
União, Brasília, DF, 20 Set. 2004. Seção I, 1 p.
th
BRAZIL. 2005. Law nº 11,105, March 24 . Diário Oficial da
União, Brasília, DF, 28 Mar. 2005. Seção I, 1 p.
th
BRAZIL. 2015a. Law nº 13,123, May 20 . Diário Oficial da
União, Brasília, DF, 21 Mai. 2005. Seção I, 1 p.
BRAZIL . 2015b. Comments on the law nº 13,123/2015.
Núcleo de Estudos e Pesquisas/CONLEG/Senado.
Consultoria legislativa do Senado. publicado em 20 de
outubro de 2015. Disponível em: <https://www.planalto.
gov.br/ccivil_03/mpv/2186-16.htm>.
An Acad Bras Cienc (2021) 93(Suppl. 4)
e20210413
21 | 24
MARCELO FOLGOSI et al.
LAW OF BRAZILIAN BIODIVERSITY AND BIOTECHNOLOGY
th
BRAZIL. 2016. Decree nº 8772, May 16 . Diário Oficial da
União, Brasília, DF, 12 Mai. 2016. Seção I, 3 p.
BRAZIL. 2017. Ordinance SECEX/CGEN nº 1 October 1st.
Diário Oficial da União, Brasília, DF, 13 Out. 2017. Seção
I, 78 p.
BUCKUP P. 2018. A quem interessa a Lei? Jorn Ciên: march.
Available in: <https://www.jornaldaciência.org.br>.
CAPOBIANCO JP, BENSUSAN N, RAMOS A & ROLLA A. 2001. Indian
lands as a key element in the biodiversity conservation
of the Brazilian Amazon. CBD Tech Series 3: 25-27.
CRUZ MF . 2018. A norma do novo: Fundamentos do
sistema de patentes na modernidade, 3a ed., Rio de
Janeiro: Lumen Juris, 412 p.
DAHMS AS. 2004. Biotechnology: what it is, what it is not,
and the challenges in reaching a national or global
consensus. Biochem Mol Biol Ed 32(4): 271-278.
DA SILVA M. 2017. A Lei da Biodiversidade: sua origem e seu
impacto na pesquisa e no desenvolvimento tecnológico
com patrimônio genético e conhecimento tradicional
associado. In: Nader HB, de Oliveira F & Mossri BB (Eds),
A ciência e o poder legislativo: relatos e experiências,
São Paulo: SBPC, São Paulo, Brazil, p. 184-194.
genético e conhecimento tradicional associado
cumprindo as exigências da Nova Lei da Biodiversidade
(Lei 13.123/2015). J Cien 5772: 1.
RABITZ F . 2017. Institutional change and structural
constraints. The global governance of genetic resources,
1st ed., London: Routledge, 186 p.
SANTILLI J. 2005a. Socioambientalismo na Constituição
Brasileira. Rev Dir Pol 6: 27-61.
SANTILLI J. 2005b. Proteção à diversidade biológica e
cultural na Constituição Brasileira de 1988. Bol Cien Esc
Sup Min Públ Fed 15: 121-149.
SANTOS HRS, GOLO OS, DA SILVA M, COELHO IS, PAIVA SR &
OLIVEIRA DR. 2018. Os impactos da legislação ambiental
brasileira sobre as coleções biológicas. Diver Gest 2:
56-61.
SCHIEL J & SMITH M. 2002. Levantamento etnoecológico do
complexo Médio Purus: em busca de uma metodologia
interdisciplinar. In: Gramcow M (Ed), Demarcando Terras
Indígenas II: experiências e desafios de um projeto em
parceria, Brasília: FUNAI/PPTAL/GTZ, Brasília, Brazil, p.
241-249.
SIMMONDS MSJ ET AL. 2020. Biodiversity and patents:
DA SILVA M. 2019. Brazil, example of a non-Nagoya Protocol
Overview of plants and fungi covered by patents. Plant
Peop Plan 2: 546-556.
DA SILVA M & OLIVEIRA DR . 2018. The new brazilian
SMITH M, DE ALMEIDA FVR, MAZUREK R, SOUZA C, WENTZEL
S & OLIVEIRA V. 2006. Apoio às iniciativas dos Povos e
country. Microbiol Austr 40(3): 106-108.
legislation on acess to the biodiversity (Law 13,123/15
and Decree 8772/16). Braz J Microbiol 49: 1-4.
Nature 463: 598.
Organizações Indígenas na Amazônia: os desafios
da construção do sistema de monitoria do PDPI. In:
Guerra R & Ascher P (Eds), Estratégias e Métodos de
Monitoramento em Projetos de Proteção das Florestas
Tropicais Brasileiras, Brasília: MMA, Brasília, Brazil, p.
57-83.
ILO - INTERNATIONAL LABOUR ORGANIZATION. 1989.
SMITH M & FAUSTO C. 2016. Socialidade e diversidade de
Indigenous and Tribal Peoples convention. https://www.
ilo.org/dyn/normlex/en/f?p=NORMLEXPUB:12100:0::NO:
:P12100_ILO_CODE:C169
pequis (Caryocar brasiliense, Caryocaraceae) entre os
Kuikuro do alto rio Xingu (Brazil). Bol Mus Para Emílio
Goeldi. Série Ciên Hum 11: 87-113.
MELO SSC. 2015. A Medida Provisória nº 2.186/2001 e a
SMITH M & PLAGNOL DV. 2016. Conhecimento e uso de
espécies vegetais arbóreas pelos seringueiros da
Reserva Extrativista do Alto Juruá, Acre. In: Siviero A, Ming
LC, Silveira M, Daly DC & Wallace RH (Eds), Etnobotânica
e botânica econômica do Acre, Rio Branco: Edufac, Rio
Branco, Brazil, p. 53-66.
FIORILLO CAP. 2019. Curso de Direito Ambiental Brasileiro,
19a ed., São Paulo: Saraiva, 952 p.
GILBERT N. 2010. Biodiversity Law Could Stymie Research.
pesquisa com a biodiversidade brasileira. Jus Nav 20:
4.301. Available in: https://jus.com.br/artigos/37960>
OBERTHÜR S & ROSENDAL GK. 2013. Access and benefit
sharing after the Nagoya Protocol. In: Oberthür S &
Rosendal GK (Eds), The global governance of genetic
resources, London/New York: Routledge, London, UK, p.
213-230.
OLIVEIRA DR, SILVA M, CARMO F & ANGELI R. 2017. Chamada
à comunidade científica para a regularização e
cadastramento de atividades envolvendo patrimônio
TAUBMAN A & LEISTENER M. 2008. Analysis of different areas
of intellectual resources: Traditional knowledge. In: Von
Lewinski S (Ed), Indigenous heritage and intellectual
property: Genetic resources, traditional knowledge, and
folklore, Alphen an den Rijn: Kluwer Law International,
2nd ed., Alphen an den Rijn, Netherland, p. 59-179.
An Acad Bras Cienc (2021) 93(Suppl. 4)
e20210413
22 | 24
MARCELO FOLGOSI et al.
LAW OF BRAZILIAN BIODIVERSITY AND BIOTECHNOLOGY
UNO - UNITED NATIONS ORGANIZATION. 1992. Convention sur
la diversité biologique signée le 5 juin 1992 à Rio de
Janeiro. Recueil des Traités des Nations Unies, vol. 1760,
Numéro de l’enregistrement: 30619. https://www.cbd.int/
convention/articles/ default.shtml?a=cbd-15.
UNO - UNITED NATIONS ORGANIZATION. 2007. United Nations
Declaration on the Righs of Indigenous Peoples. https://
www.un.org/development/desa/indigenouspeoples/
declaration-on-the-rights-of-indigenous-peoples.html.
WILLIAMS C ET AL. 2020. Conservation Policy: Helping or
MIRIAM A. DE SOUZA1,11
https://orcid.org /0000-0001-7153-9335
RITA L. PAIXÃO1,12
https://orcid.org/0000-0002-2895-9091
GUTEMBERG G. ALVES1,13
https://orcid.org/0000-0003-0016-4809
MARCELO S. GONZALEZ 1,14
https://orcid.org/0000-0002-5442-6440
hindering science to unlock properties of plants and
fungi. Plant Peop Plan 2: 535-545.
SELMA R. DE PAIVA1, 15
WTO - WORLD TRADE ORGANIZATION. 2005. Annual Report.
1
th
10 Anniversary 1995-2005. https://www.wto.org/english/
res_e/booksp_e/anrep_e/anrep05_e.pdf.
https://orcid.org/0000-0002-8295-7011
Comitê de Acesso ao Patrimônio Genético e
Conhecimento Tradicional Associado da Universidade
Federal Fluminense, Rua Passo da Pátria, 152470, São Domingos, 24210-240 Niterói, RJ, Brazil
2
How to cite
FOLGOSI M. ET AL. 2021. New Law of Brazilian Biodiversity: Legal Aspects
and Impact in the Field of Biotechnology. An Acad Bras Cienc 93:
e20210413. DOI 10.1590/0001-3765202120210413.
Manuscript received on March 20, 2021;
accepted for publication on July 31, 2021
MARCELO FOLGOSI1,2
https://orcid.org/0000-0001-7810-5679
ALESSANDRA L. VALVERDE1,3
https://orcid.org/0000-0002-1250-1051
SORELE B. FIAUX1,4
https://orcid.org/0000-0002-9280-9397
SAMANTHA C. MOURÃO1,4
https://orcid.org/0000-0001-6518-2325
Programa de Pós-Graduação em Ciências e Biotecnologia,
Universidade Federal Fluminense/UFF, Instituto de Biologia,
Departamento de Biologia Geral, Rua Professor Marcos
Waldemar de Freitas Reis, s/n, Campus do Gragoatá, Bloco
M, Sala 229, São Domingos, 24210-201 Niterói, RJ, Brazil
3
Programa de Pós-Graduação em Química, Universidade
Federal Fluminense/UFF, Instituto de Química,
Departamento de Química Orgânica, Outeiro de São
João Batista, s/n, Centro, 24020-141 Niterói, RJ, Brazil
4
Programa de Pós-Graduação em Ciências e Biotecnologia/
UFF, Universidade Federal Fluminense/UFF, Faculdade
de Farmácia, Departamento de Tecnologia Farmacêutica,
Rua Dr. Mario Viana 523, 24241-000 Niterói, RJ, Brazil
5
Universidade Federal Fluminense/UFF, Agência de
Inovação, Campus da Praia Vermelha, Rua Passo
da Pátria 156, Prédio Novo da Física, 3º andar,
São Domingos, 24210-240 Niterói, RJ, Brazil
6
RICARDO H. LEAL1,5
Universidade Federal Fluminense/UFF, Instituto
Biomédico, Departamento de Imunologia e
Microbiologia, Alameda Barros Terra, Bloco E, Sala
612, São Domingos, 24020-150 Niterói, RJ, Brazil
ALOYSIO M.F. CERQUEIRA1,6
7
https://orcid.org/0000-0001-9167-5668
https://orcid.org/0000-0003-2257-8965
SÁVIO F. BRUNO1,7
https://orcid.org/0000-0002-7267-9310
OLIVIA V.D. WEID1,8
https://orcid.org/0000-0003-0433-6890
RENATA ANGELI9
https://orcid.org/0000-0001-5217-8490
JOSÉ C.D. NETO1,10
Universidade Federal Fluminense/UFF, Departamento de
Clínica e Reprodução Animal, Faculdade de Veterinária, Av.
Almirante Ary Parreiras, 507, Icaraí, 24220-000 Niterói, RJ, Brazil
8
Universidade Federal Fluminense/UFF, Instituto
de Ciências Humanas e Filosofia, Departamento
de Antropologia, Rua Professor Marcos Waldemar
de Freitas Reis, s/n, Bloco O, Campus do Gragoatá,
São Domingos, 24210-201 Niterói, RJ, Brazil
9
Fundação Centro Universitário da Zona Oeste/UEZO, Unidade
de Biologia, NIT/UEZO, Rua Manuel Caldeira de Alvarenga,
1203, Campo Grande, 23070-200 Rio de Janeiro, RJ, Brazil
https://orcid.org/0000-0001-6346-3297
An Acad Bras Cienc (2021) 93(Suppl. 4) e20210413
23 | 24
MARCELO FOLGOSI et al.
LAW OF BRAZILIAN BIODIVERSITY AND BIOTECHNOLOGY
10
Universidade Federal Fluminense/UFF, Instituto de
Ciências da Sociedade e Desenvolvimento Regional,
Departamento de Ciências Sociais, Rua José do Patrocínio,
71, 28010-385 Campos dos Goytacazes, RJ, Brazil
11
Programa de Pós-Graduação em Justiça e SegurançaUFF, Universidade Federal Fluminense/UFF, Instituto
de Ciências Humanas e Filosofia, Departamento
de Antropologia, Rua Professor Marcos Waldemar
de Freitas Reis, s/n, Bloco O, Sala 520, Campus do
Gragoatá, São Domingos, 24210-201 Niterói, RJ, Brazil
12
Universidade Federal Fluminense/UFF, Instituto Biomédico,
Departamento de Fisiologia e Farmacodinâmica, Rua Hernani
Melo 101, São Domingos, 24210-130 Niterói, RJ, Brazil
Aloysio de Mello Figueiredo Cerqueira and Rita Leal Paixão
performed revisions and suggestions to improve the quality
of the manuscript. Sávio Freire Bruno: helped in elaboration of
concept and methodology. Olivia Von Der Weid and Gutemberg
Gomes Alves: orientation in the development of the work,
writing in the original draft and in the final version. Renata
Angeli: performed revisions and suggestions to improve the
quality of the manuscript. José Colaço Dias Neto: formal
analysis, helping in the interpretation of the results and writing
about them. Marcelo Salabert Gonzalez & Selma Ribeiro de
Paiva: orientation in the development of the work, writing in the
original draft, performing revisions and suggestions to improve
the quality of the manuscript.
13
Programa de Pós-Graduação em Ciências e Biotecnologia,
Universidade Federal Fluminense/UFF, Instituto de Biologia,
Departamento de Biologia Celular e Molecular, Campus
do Gragoatá, Rua Professor Marcos Waldemar de Freitas
Reis, s/n, Bloco M, São Domingos, 24210-201 Niterói, RJ, Brazil
14
Programa de Pós-Graduação em Física Aplicada/UFRJ,
Instituto Nacional de Entomologia Molecular, Centro de
Tecnologia, Av. Athos da Silveira Ramos, 149, Bloco A,
Cidade Universitária, 21941-972 Rio de Janeiro, RJ, Brazil
15
Programa de Pós-Graduação em Ciências Aplicadas a
Produtos para a Saúde, Universidade Federal Fluminense/
UFF, Instituto de Biologia, Departamento de Biologia
Geral, Campus do Gragoatá, Rua Professor Marcos
Waldemar de Freitas Reis, s/n, Bloco M, Salas T108 e
T111, São Domingos, 24210-201 Niterói, RJ, Brazil
Correspondence to: Marcelo Gonzalez
E-mail: msgonzalez@id.uff.br
Author contributions
Marcelo Folgosi (main author): responsible for the database
obtention, result analysis, preparing and writing of draft
and manuscript, translation of the manuscript to English,
and adequation to the reviews requested by the reviewers.
Alessandra Leda Valverde and Miriam Alves de Souza:
supervision and orientation in the development of the
work. Sorele Batista Fiaux: helping in both the processing
of the database and the interpretation of the results in the
original draft and in the review. Samanta Cardozo Mourão
performed revisions and suggestions to improve the quality
of the manuscript. Ricardo Henriques Leal: helped in the
accuracy assessment in the original draft and in the review.
An Acad Bras Cienc (2021) 93(Suppl. 4)
e20210413
24 | 24