This following translation was furnished by Translation
Service of the Secretariat of Information and Documentation within Brazil's Federal
Translated from Portuguese by Vanira Tavares.
BILL OF LAW Nš 306/95
Emended version presented by Rapporteur Senator Osmar Dias (PSDB/PR),
as approved by the Commission on Social Affairs of the Federal Senate of Brazil,
on November 19, 1997
Provides for the access to genetic resources and their derived products and makes other provisions.
THE NATIONAL CONGRESS decrees:
Article 1. This Act provides for rights and duties concerning the
access to genetic resources, genetic material, and derived products, in ex
situ or in situ conditions, existing in the Brazilian territory or having
Brazil as their country of origin, to traditional knowledge possessed by
indigenous populations and local communities, associated with genetic
resources or derived products and with domesticated and semi-domesticated
crops in Brazil.
Article 2. Genetic resources and derived products are considered
public property of special use of the Brazilian Nation, and the contracts
of access to them shall be carried out under the terms of this Act, without
prejudice to material and immaterial property rights relating to:
I - the natural resources containing the genetic resource or
II - the lands traditionally inhabited by Indians and their
exclusive enjoyment of the riches existing in such lands;
III - the private collection of genetic resources or derived products;
IV - the traditional knowledge possessed by indigenous populations
and local communities, associated with genetic resources or derived
V - the domesticated and semi-domesticated crops in Brazil.
Sole paragraph. The owners and holders of goods and rights referred
to in this article shall be ensured of the fair and equitable sharing of
the benefits derived from the access to genetic resources, to the
traditional knowledge possessed by indigenous populations and local
communities associated with genetic resources and derived products, and to
the domesticated and semi-domesticated crops in Brazil, under the terms of
Article 3. The legal classification presented in the previous
article does not apply to the genetic resources and any components or
substances of human beings, with due regard to the provisions of article 8
of this Act.
DEFINITION OF TERMS AND GENERAL PROVISIONS
Definition of Terms
Article 4. For the purposes of this Act, the following definitions
ACCESS TO GENETIC RESOURCES: acquisition and utilization of genetic
resources, genetic material and derived products, in ex situ or in situ
conditions, existing in the Brazilian territory or having Brazil as their
country of origin, of knowledge possessed by indigenous populations and
local communities associated with genetic resources or derived products,
and of domesticated and semi-domesticated crops in Brazil, for purposes of
research, bioprospecting, conservation, industrial application or
commercial exploitation, among others.
COMPETENT AUTHORITY: public agency appointed by the Government to enter
into contracts regarding the access to genetic resources, which must
include benefit sharing and the access to and the transfer of technology,
as set forth in this Act.
BIOTECHNOLOGY: any technological application which uses biological systems
or living organisms, part of them or their derived products, to make or
modify products or processes for specific utilization.
EX SITU CONSERVATION CENTER: institution recognized by the competent
authority, which collects and conserves the components of biological
diversity out of their natural habitats.
TRADITIONAL KNOWLEDGE: any knowledge, innovation, or individual or
collective practice of an indigenous population or local community, having
real or potential value, associated with a genetic resource or derived
product, protected or not by intellectual property legislation.
LOCAL COMMUNITY AND INDIGENOUS POPULATION: human group differentiated by
its social, cultural and economic conditions, organized, in total or in
part, according to its own customs and traditions or by special
legislation, and preserving, whatever juridical status it has, its own
social, economic, and cultural institutions, or part of them.
EX SITU CONDITIONS: conditions in which the components of biological
diversity are conserved out of their natural habitats.
IN SITU CONDITIONS: conditions in which genetic resources exist in
ecosystems and natural habitats, and, in the case of domesticated and
cultivated species, in the environments where they have developed their
CONTRACT OF ACCESS: agreement between the competent authority and
individuals or corporate bodies, establishing the terms and conditions for
their access to genetic resources and their subsequent utilization, which
must include benefit sharing and the access to and the transfer of
technology, as set forth in this Act.
BIOLOGICAL DIVERSITY: variability of living organisms of all origins,
comprising land and marine ecosystems and other water ecosystems, and the
ecological complexes they integrate, as well as genetic diversity, the
diversity of species and of ecosystems.
GENETIC DIVERSITY: variability of genes and of genotypes among and in
species; part or the whole of the genetic information contained in
ECOSYSTEM: a dynamic complex of plant, animal and microorganism
communities, and their inorganic environment, which interact as a
GENETIC EROSION: loss or reduction of genetic diversity, due to anthropic
action or natural causes.
GENETIC MATERIAL: any biological material of plant, animal, microbial or
other origin, which contains functional units of heredity.
COUNTRY OF ORIGIN OF GENETIC RESOURCES: country which possesses these
genetic resources in in situ conditions, including those which, having been
in such conditions, are now in ex situ conditions under Brazilian
DERIVED PRODUCT: isolated natural product of biological origin, or
structurally based on it, or having been in some way created from the
utilization of a traditional knowledge associated with it.
PROVIDER OF TRADITIONAL KNOWLEDGE: community or group empowered, under the
terms of this Act and by means of the contract of access, to take part in
the decision-making process regarding the provision of the traditional
knowledge it possesses.
PROVIDER OF GENETIC RESOURCE: individual or corporate body, indigenous
population or local community, empowered, under the terms of this Act and
by means of the contract of access, to take part in the decision-making
process regarding the provision of a genetic resource, genetic material, or
their derived products.
BIOLOGICAL RESOURCES: organisms or parts of them, populations or any other
biotic component of ecosystems, comprising genetic resources.
GENETIC RESOURCES: genetic material of actual or potential value, including
the genetic variability of species of plants, animals and microorganisms
which make up biological diversity, of present or potential social and
economic interest, for immediate utilization or genetic improvement, in
biotechnology, in other sciences or in related undertakings.
BENEFIT SHARING: comprises measures to promote and ensure the distribution
of outcomes, either economic or not, of research, development,
commercialization or licensing derived from the access to genetic
resources, including the access, transfer of technology and biotechnology,
and the participation in research and development activities related to
SUSTAINABLE USE: utilization of components of biological diversity in such
a manner and in such a pace so as not to bring about the long-term
reduction of biological diversity, thus preserving its potential to meet
the needs and aspirations of the present and future generations.
Article 5. It is incumbent upon every individual and corporate
body, and upon the State, in particular, to preserve the genetic patrimony
and the biological diversity of the Country, to promote their study and
sustainable use and to control the activities of access to genetic
resources, as well as to oversee the institutions engaged in prospecting,
collection, research, conservation, manipulation, commercialization, among
other activities related to such resources, under the terms of this Act,
with due regard to the following principles:
I - integrity of the genetic patrimony and of the biological
diversity of the Country;
II - national sovereignty over the genetic resources and their
derived products, existing in the Brazilian territory;
III - need of justified prior consent of the local communities and
indigenous populations for the activities of access to the genetic
resources located in the areas they inhabit, to their domesticated and
semi-domesticated crops, and to the traditional knowledge they possess;
IV - intellectual integrity of the traditional knowledge possessed
by the local community or indigenous population, it being ensured the
recognition, protection, fair and equitable compensation for its
utilization, and freedom of exchange among their members and with other
similar communities and populations;
V - inalienability, restraint of mortgage, and imprescriptibility
of rights relating to the traditional knowledge possessed by the local
community or indigenous population and to their domesticated and
semi-domesticated crops, their utilization being possible, however, with
justified prior consent of the respective local community or indigenous
population, and by means of fair and equitable compensation, under the
terms of this Act;
VI - national participation in the economic and social benefits
arising from the activities of access, especially for the benefit of the
sustainable development of the areas allowing access to genetic resources
and of the local communities and indigenous populations providing
VII - priority of implementation in the Brazilian territory to the
processing, research and development related to the genetic resources to
which access was granted;
VIII - promotion of and support for the various forms of
generation, to the benefit of the Country, of knowledge and technologies
related to genetic resources and derived products;
IX - protection and encouragement of cultural diversity,
highlighting the knowledge, innovations and practices of the local
communities and indigenous populations related to the conservation,
improvement, use, management, and exploitation of genetic resources and
their derived products;
X - compatibility with policies, principles and rules related to
XI - compatibility with policies, principles and rules related to
food safety of the Country;
XII - compatibility with policies, principles and rules related to
the national policies of environmental protection;
XIII - compliance with and strengthening of the Convention on
Biological Diversity and other international agreements regarding the
conservation and sustainable use of biodiversity.
Article 6. The contracts of access to genetic resources, their
control and oversight are aimed at the conservation, study and sustainable
use of the biological diversity of the Country, the provisions of this Act
being applied to all individuals or corporate bodies, either Brazilian or
foreign, as well as to:
I - any activity of extraction, use, exploitation, storing or
commercialization, in the Brazilian territory, of genetic resources or
their derived products; and,
II - any agreement or contract, public or private, regarding
genetic resources and derived products originating in the Country.
Article 7. This Act applies to the inland, coastal, marine and
island genetic resources and their derived products existing in the
Brazilian territory or having Brazil as their country of origin, as well as
to the associated traditional knowledge possessed by local communities and
indigenous populations, and to the migrating species which, for natural
causes, are present in the Brazilian territory.
Article 8. This Act does not apply:
I - to the genetic materials and any components or substances of
human beings, with any collection or use of these resources, components or
substances being subject to approval by the Executive Power, upon justified
prior consent of the individual concerned, while a specific act regulating
the matter does not come into force;
II - to the exchange of genetic resources, derived products,
traditional crops or associated traditional knowledge, carried out by the
local communities and indigenous populations, among themselves, for their
own purposes and based on their customary practices;
Article 9. The use, either direct or indirect, of biological
resources, genetic resources, or genetic materials and derived products in
biological weapons or in practices which are harmful to the environment or
to human health is forbidden.
Article 10. To ensure compliance with the provisions of this Act,
the Federal Government shall appoint an agency of the Direct Administration
to carry out the functions of competent authority and to be responsible for
authorizing access to genetic resources.
Article 11. The decisions of the competent authority with respect
to the national policy of access and to the authorizations of access shall
be signed by a Genetic Resources Committee, to be established by the
Executive Power, made up of representatives of the Federal Government, the
state governments and the Federal District, the scientific community, the
local communities and indigenous populations, the agencies of access, the
non-governmental organizations and private companies, with parity of
representation of members of the Government and of the communities and
non-governmental institutions, the institutions of education and research
being included among the latter.
Sole paragraph. The competent authority shall carry out the
functions of executive secretariat of the Genetic Resources Committee,
according to the regulations.
Article 12. In addition to signing contracts of access, it is
incumbent upon the competent authority, upon opinion of the Genetic
Resources Committee and with due regard to the provisions of this Act and
of any other legislation and environmental policy tools:
I - to prepare, coordinate and carry out the national policy of
access to genetic resources, with a view to preserving the diversity and
integrity of the national genetic patrimony;
II - to oversee, control and assess the activities of access to
genetic resources developed in the Country;
III - to support the issuing and updating of periodical reports
about the degrees of threat to the national biodiversity and about the
actual and potential impacts on its preservation;
IV - to cooperate with agencies of the Executive Power,
international organizations, local communities and non-governmental
organizations in the preparation of lists of biological resources
threatened of extinction or of deterioration, and of areas in danger of
serious loss of biodiversity, as well as in the definition of the necessary
mechanisms of control;
V - to contribute to the disclosure of information regarding
threats to the national biological diversity;
VI - to monitor and promote researches and inventories of the
national biological diversity and develop mechanisms to organize and
maintain this information;
VII - to contribute to the development of activities of ex situ
conservation of genetic resources;
VIII - to identify priorities and promote the training of the
personnel necessary to the activities of access, as well as to propose
Article 13. At any time, in case of danger of serious and
irreparable damage deriving from activities carried out under the terms of
this Act, the Government, based on a technical opinion and on
proportionality criteria, shall adopt measures to prevent such damage and
may even stop the activity, especially in the following cases:
I - endangered species, subspecies, lineages or varieties;
II - reasons of endemism or rarity;
III - vulnerable conditions of the structure or functioning of
IV - adverse effects on human health or on the quality of life or
cultural identity of the local communities and indigenous populations;
V - environmental impacts which are undesirable or difficult to
control, upon urban and rural ecosystems;
VI - danger of genetic erosion or loss of ecosystems, of their
resources or components, because of undue or uncontrolled collection of
VII - non-compliance with biosafety or food safety rules and
VIII - use of resources for purposes contrary to national interests
and to the agreements entered into by the Country.
Sole paragraph. The lack of absolute scientific certainty regarding
the cause and effect relationship between the activity of access to genetic
resources and the damage may not be presented as a reason to disregard the
adoption of the necessary effective measures.
ACCESS TO GENETIC RESOURCES
Access to Resources in In situ Conditions
Article 14. Any procedure of access to genetic resources in the
Brazilian territory, in in situ conditions, shall be subject to prior
authorization of the competent authority and to the signing and publication
of a contract between the competent authority and the individuals and
corporate bodies concerned.
Sole paragraph. The competent authority shall keep a reference file
of public institutions and non-profit private organizations which carry out
activities related to the conservation and sustainable use of natural
resources, referred to as "agencies of access" for the purposes of this
Act, empowered to request access on behalf of third parties, discuss
additional contracts and clauses for the protection of rights relating to
traditional knowledge, and manage projects and investment of funds derived
from contracts of access.
The Petition and the Project of Access
Article 15. To obtain authorization and sign a contract of access
to a genetic resource, the petitioner or the agency of access must present
a petition, together with the project of access, including at least the
I - curriculum vitae and complete identification, including those
of the respective responsible persons:
a) of the petitioner of access, either an individual or a corporate
body who will implement the access, and who must have both the legal
capacity to sign a contract and proven technical capacity, including
information about all the persons or institutions who will be involved in
the procedures of access;
b) of the agency of access, including the file registration and the
contract with the petitioner of access, as the case may be;
c) of the holder of the natural resource containing the genetic
resource, or of the collection of genetic resources, as the case may be;
d) of the provider of traditional knowledge;
e) the name of the public institution of education, of research or
of public interest domiciled in Brazil, in charge of monitoring the
procedures of access.
II - complete information on the timetable, budget and sources of
financing for the activities scheduled;
III - detailed and specified description of the genetic resources,
derived products or traditional knowledge to which access is intended,
including their current and potential uses, their environmental
sustainability, and the risks which may arise from such access;
IV - detailed description of the methods, techniques, collection
systems and tools to be used;
V - precise location of the areas where the procedures of access
will be carried out;
VI -indication of the destination of the material collected and of
its probable future use.
Paragraph 1. In the case of access to traditional knowledge, the
project referred to in this article shall include an authorization to visit
the local community or indigenous population, as well as the information
collected, from an oral or a written source, related to the traditional
Paragraph 2. The competent authority shall also, when it deems
necessary, require the presentation of an environmental impact study and
report related to the activities to be carried out.
Article 16. If the petition and project of access are considered
complete, the competent authority will grant it a date, hour and number of
registration and, within 15 (fifteen) days as of such date, it will take
the following steps:
I - publication of an abstract of the petition and of the project
of access in the Federal Official Gazette;
II - publication of an abstract of the petition and of the project
of access, for 3 (three) consecutive days, in the newspaper of highest
circulation figures in the region where the access will take place;
III - when the institution assigned by the petitioner or by the
agency of access is not approved, indication of at least three institutions
which may be assigned to monitor the procedures of access under the terms
of this Act.
Sole paragraph. If the petition and the project of access are
deemed incomplete, they may not be accepted by the competent authority, who
shall immediately return them for correction.
Article 17. Within 60 (sixty) days as of the publication of the
petition and project of access, the competent authority shall start its
examination, analyzing the information provided according to article 15,
carrying out the necessary inspections, and, based upon a
technical-juridical opinion and upon the opinions expressed by any
interested party, submitted within the legal time period, it shall make a
decision whether to accept the petition or not.
Paragraph 1. The deadline stipulated in the caption may be
extended, at the discretion of the competent authority.
Paragraph 2. The petitions of access to take place in conservation
units shall be subject to an opinion of the competent agencies, to be
issued without prejudice to the deadline stipulated in the caption.
Paragraph 3. The petitions of access to take place in indigenous
areas shall be subject to an opinion of the competent agencies, to be
issued without prejudice to the deadline stipulated in the caption, as well
as to the justified prior consent of the indigenous community concerned,
under the terms of this Act.
Article 18. Before the end of the time period for examination, the
competent authority, based on the opinion provided for in the previous
article, shall grant or dismiss the petition by means of a justified
Paragraph 1. The decision to dismiss shall be communicated to the
interested party and shall be the final step of the procedures, without
prejudice to the admissible administrative or judicial appeals.
Paragraph 2. The decision to grant the petition shall be
communicated to the interested party within 10 (ten) days and published in
the Official Gazette and in the newspaper of highest circulation figures in
the region where the access will take place, being followed by the
discussion and preparation of the contract of access.
The Contract of Access
Article 19. The following are the parties to the contract of access:
a) the State, represented by the competent authority;
b) the petitioner of access;
c) the agency of access;
d) the provider of traditional knowledge or domesticated crop, in
the case of contracts of access involving such components.
Article 20. When the petition of access involves a traditional
knowledge or domesticated crop, the contract of access shall include, as an
integral part, an annex referred to as a supplementary contract on the
utilization of traditional knowledge or domesticated crop, undersigned by
the competent authority, by the provider of traditional knowledge or
domesticated crop, by the petitioner and the agency of access, as the case
may be, stipulating a fair and equitable compensation with respect to the
benefits arising from such utilization, the form of such participation
being expressly indicated.
Article 21. During the stage of discussion of the contract of
access, the petitioner or agency of access shall submit to the competent
authority the additional contracts they may have entered into with third
parties, under the terms of this Act.
Paragraph 1. The public or private institution operating as
national support, under an additional contract set forth in this Act, shall
be accepted by the competent authority.
Paragraph 2. The acceptance set forth in the previous paragraph
shall not, by any means, render the competent authority responsible for
compliance with the respective additional contract.
Article 22. The contract of access, as determined by the terms and
clauses mutually agreed upon by the parties, shall include, in addition to
the information provided by the petitioner or the agency of access, all of
the conditions and duties to be fulfilled, as follows:
I - definition of the object of the contract, as registered in the
petition and project of access;
II - determination of the holders of possible intellectual property
rights and the commercialization of products and processes obtained, as
well as of the conditions for the granting of licenses;
III - obligation of the petitioner and of the agency of access not
to forego or transfer to third parties the access, management or
utilization of genetic resources and their derived products without the
express consent of the competent authority, and, as the case may be, of the
local communities or indigenous populations who possess the traditional
knowledge or domesticated crop, subject to a procedure of access;
IV - commitment of the petitioner and of the agency of access to
give prior notice to the competent authority about the researches and
utilization of the genetic resources and derived products subject to access;
V - commitment of the petitioner and of the agency of access to
submit to the competent authority the reports and other publications
prepared about the genetic resources and derived products subject to access;
VI - commitment of the petitioner and of the agency of access to
give prior notice to the competent authority about new products or
processes obtained, or products or processes different from those stated in
VII - obligation of the petitioner and of the agency of access to
submit to the competent authority regular reports of the results attained;
VIII - commitment of the petitioner and of the agency of access to
request prior authorization of the competent authority for the transfer or
transportation of genetic resources and derived products to areas other
than those assigned for the procedure of access;
IX - obligation to deposit samples of the genetic resource and
derived products subject to access, including any associated material, at
an institution assigned by the competent authority, single samples being
expressly prohibited to leave the Country;
X - eventual commitments of confidentiality, without prejudice to
the rights arising from traditional knowledge and to the juridical status
provided for access by this Act;
XI - eventual commitments of exclusive access for the petitioner
and the agency of access, provided that they are in compliance with the
national legislation on free competition, without prejudice to the rights
arising from traditional knowledge and to the juridical status adopted for
access by this Act;
XII - stipulation of a guarantee which ensures compensation, in the
case of non-compliance with the clauses of the contract by the petitioner
and by the agency of access;
XIII - stipulation of compensation clauses in the case of lack of
fulfillment of contract and extra-contract duties, as well as of damages to
XIV - compliance with any other national rules, especially those
regarding sanitation control, biosafety, protection of the environment and
Article 23. The term of the contract of access shall be determined
by the competent authority, the maximum period being 3 (three) years as of
the date of its signing, renewable for periods of the same length as the
Sole paragraph. Without prejudice to other rescissory clauses
agreed upon, the competent authority may rescind the contract of access at
any time by virtue of a provision of this Act.
Article 24. The data and information contained in the petition,
proposal, authorization and in the contract of access may be subject to
confidential treatment, in case third parties may make unfair commercial
use of them, except when their disclosure is necessary to the protection of
public interest, of the environment or of rights regarding traditional
Paragraph 1. For the purposes stated in the caption, the petitioner
or the agency of access shall submit a justified petition, together with a
non-confidential summary, to be part of the published documents.
Paragraph 2. The confidential data shall be kept by the competent
authority and may not be disclosed to third parties, except by means of a
Paragraph 3. Confidentiality may not be applied to the information
referred to in items I, IV and V of article 15.
Article 25. The competent authority may sign, with state-owned or
public utility research centers and universities, domiciled in the Country,
agreements to provide for the carrying out of one or more contracts of
access, in compliance with the procedures stated in this Act, it being
waived, in such cases, the need to assign an institution to monitor the
activities of access, in accordance with the provisions of articles 15 and
Article 26. The contracts signed in violation of this Act shall be
null and void, and their nullity may be decreed ex officio by the competent
authority, or at the petition of any person.
The Provisional Bioprospecting Contract
Article 27. Authorizations may be requested and contracts of access
may be signed without compliance with items III and VI of article 15, in
which case they shall be referred to as provisional authorizations and
contracts, in areas having their location and size defined by the competent
authority, with due regard to the ecological zoning of the Country, the
following being observed:
I - the contract mentioned in this article shall be in force for
not more than 1 (one) year) as of the date of its signing, not being
II - the contract mentioned in this article shall provide for a
detailed report of the bioprospecting which was carried out, to be
submitted to the competent authority within 120 (one hundred and twenty)
days as of the date of expiration of the contract, and which will be
considered confidential for 1 (one) year as of the expiration of the
III - the commercial utilization of products or processes obtained
from procedures of access carried out under the terms of provisional
contracts shall not be authorized;
IV - the access to the genetic resources found in the area shall be
subject to an authorization and a contract prepared in accordance with the
V - the party to the contract mentioned in this article shall have
priority to receive authorization and to sign a contract of access to the
genetic resources prospected in the area, and this priority may be used
within 1 (one) year as of the expiration of the contract.
The Additional Contracts of Access
Article 28. The additional contracts of access are those necessary
to the implementation and development of activities relating to access to
genetic resources, and that have been entered into by the petitioner or the
agency of access and:
a) the owner or holder of the natural resource which contains the
b) the holder of a collection of genetic resources in ex situ or in
c) the public or private institution assigned, under the terms of
this Act, to monitor the activities of access, involving obligations which
should not be part of the contract of access.
Sole paragraph. The additional contracts shall stipulate a fair and
equitable share for the parties in the benefits arising from access to the
genetic resource, the form of such sharing being expressly indicated.
Article 29. Without prejudice to the provisions of the additional
contract and notwithstanding such a contract, the public or private
institution shall be required to cooperate with the competent authority in
the monitoring and controlling of the activities of access, and to submit
reports about the activities under its responsibility, in the manner and as
often as the authority determines, the suitability to the nature of the
activities under the contract being ensured.
Article 30. The signing of an additional contract does not
authorize access to a genetic resource, and its contents must be compatible
with the provisions of the contract of access and of this Act.
Article 31. The additional contracts shall include a suspensive
clause, conditioning their implementation to the carrying out of the
contract of access.
Article 32. The nullity of the contract of access causes the
nullity of the additional contract.
Paragraph 1. The competent authority may rescind the contract of
access when the nullity of the additional contract is declared, if the
latter is essential to the completion of the access.
Paragraph 2. The alteration, suspension, or rescission of the
additional contract may imply the alteration, suspension, or rescission of
the contract of access by the competent authority, if they have a
substantial effect on the conditions of the latter.
The Implementation and Monitoring of the Contracts of Access
Article 33. The procedures of access must be monitored by a
Brazilian institution of education or of research, either public or
private, of undisputed repute in the area subject to the procedure,
approved by the competent authority and hired by the petitioner or by the
agency of access, before the authorization.
Sole paragraph. The institution so assigned has joint and several
liability for the fulfillment of the obligations undertaken by the
individual or corporate body authorized to carry out the procedure of
Article 34. It is incumbent upon the competent authority, together
with the institution assigned to monitor the authorized activities, to
monitor the compliance with the provisions of the authorization and of the
contract of access and, especially, to ensure that:
I - access is obtained exclusively to the authorized genetic
resources and derived products, when it is not the case of a provisional
contract, and in the established area;
II - the environmental conditions of the region where the
activities take place are preserved;
III - there is permanent direct participation of an expert from the
IV - a detailed account of the activities carried out and of the
destination of the samples collected is presented;
V - samples of the species collected are handed over to be
conserved ex situ by the institution assigned by the competent authority.
Article 35. In addition to the payments and sharing of benefits
agreed upon by the petitioner, the agency of access, the providers of
traditional knowledge and the other parties to the additional contracts, a
fair compensation is ensured to the State, in the form of money or
commercialization rights, in the manner stipulated by the contract of
access signed by the competent authority and the other parties.
Article 36. The forms of compensation stated in this section shall
make up a special fund for the conservation, research and inventory of the
genetic patrimony, designed to be a tool of financial support to projects
related to the access to and the conservation of genetic resources and to
the knowledge associated with genetic resources.
Sole paragraph. The projects stated in this article shall be
selected by the competent authority, whose decision shall be confirmed by
the Genetic Resources Committee, subject to the availability of funds and
to compatibility with the principles established in this Act.
General Provisions for the Contracts of Access
Article 37. The permits, authorizations, licenses, contracts and
other documents regarding the research, collection, acquisition, storing,
transportation, or any other similar activity related to the access to
genetic resources, in force at the date of publication of this Act, in
accordance or not with the provisions thereof, do not condition neither
presuppose the authorization for access.
Article 38. The individuals or corporate bodies authorized to
develop activities of access to genetic resources are required to transmit
to the competent authority any information regarding the transportation of
the material collected, and they also have civil, criminal and
administrative responsibility for the inadequate use or handling of such
material and for the adverse effects of such activities.
Article 39. The authorization or contract of access to genetic
resources do not imply authorization to remit them abroad, in which case
authorization must be previously requested and justified before the
Sole paragraph. It is totally forbidden to remit single samples
abroad, without due regard to the provisions concerning the mandatory
deposit of samples of every genetic resource or derived product which may
have been subject to access.
Article 40. It is illegal to use genetic resources and derived
products for purposes of research, conservation, industrial or commercial
applications, or any other purposes, if the access has not taken place
according to the provisions of this Act.
Article 41. The rights upon genetic resources and derived products
obtained or used in violation of this Act shall not be recognized, and the
certificates of intellectual property or similar certificates upon such
resources or derived products or upon products or processes resulting from
access under such circumstances shall not be considered valid.
Sole Paragraph. The depositors of intellectual creations subject to
protection by copyright, industrial property, crops or any other mode of
intellectual property, being based on any genetic resources or traditional
knowledge, as well as those based on the cultural or artistic traditions of
local communities or indigenous populations, must present a certificate of
approval by the communities or populations, to be obtained before
requesting legal protection of the creation and in compliance with the laws
of the country of origin of the genetic resource or of the traditional
The Access to Resources in Ex situ Conditions
Article 42. The competent authority may sign contracts of access to
genetic resources which are deposited in ex situ conservation centers
located in the Brazilian territory, or in other countries, provided that
Brazil is the country of origin of the resources.
Sole paragraph. The provisions regarding access to resources in in
situ conditions shall apply, where appropriate, to access to resources in
ex situ conditions.
Article 43. The genetic material transfer agreements or similar
agreements between ex situ conservation centers or between such centers and
third parties, either within the Brazilian territory or through importation
or exportation, constitute modes of contracts of access.
Paragraph 1. The conservation center providing the genetic resource
shall submit a petition of access to the competent authority, who will
publish an extract of the petition in the Official Gazette within 15
(fifteen) days as of the respective date.
Paragraph 2. The agreements stated in the caption shall be valid
provided that they are compatible with the conditions agreed upon in the
original contract of access to the resource exchanged, and with the
intellectual property rights concerned.
Paragraph 3. In its analysis of the petition of access, the
competent authority may demand financial compensation, under the terms of
this Act, which compensation shall be mentioned in the genetic material
transfer agreement or similar agreement.
Paragraph 4. In its analysis of the petition of access, the
competent authority must take into consideration the opinions presented by
any interested party.
Paragraph 5. The agreement may only be signed by the conservation
center and the interested party after validation of the proposal of
agreement by the competent authority.
THE PROTECTION OF TRADITIONAL KNOWLEDGE
ASSOCIATED WITH GENETIC RESOURCES
Article 44. The State recognizes and protects the rights of local
communities and indigenous populations to benefit from their traditional
knowledge collectively, and to receive compensation for the conservation of
genetic resources, by means of payments in money, goods, services,
intellectual property rights or other mechanisms.
Paragraph 1. It is incumbent upon the Public Prosecution to take
judicial and extrajudicial measures to protect Brazilian genetic resources
and to defend the interests and rights of local communities and of
Paragraph 2. The competent authority shall create a national
reference file, where the local communities, the indigenous populations,
and any other interested party may deposit records of knowledge associated
with genetic resources.
Paragraph 3. Every record deposited in the national reference file
shall be submitted to an ethnologic appraisal, and shall be used as a basis
for decisions concerning the terms of the contract of access.
Paragraph 4. By means of agreements, the collections of traditional
knowledge belonging to other institutions, either Brazilian or foreign, may
be deposited in the national reference file, for the same purpose of the
Paragraph 5. The records mentioned in this article are not
mandatory, and their non-existence are not a condition for, neither does it
preclude the exercise of any right set forth in this Act.
Article 45. The local communities and indigenous populations have
exclusive rights over their traditional knowledge, and they alone are
entitled to surrender them, by means of the types of contract set forth in
Sole paragraph. The proposal of contract of access may only be
accepted if it is preceded by justified prior consent of the local
community or indigenous population, obtained according to clear and precise
rules which shall be stipulated for this procedure by the competent
Article 46. The local communities and indigenous populations are
ensured of the right to the benefits arising from access to genetic
resources carried out in the areas they inhabit, defined under an
additional contract referred to in this Act, and following justified prior
consent as stated in the preceding article.
Sole paragraph. The local communities and indigenous populations
may request that the competent authority deny access to genetic resources
in the areas they inhabit, if they believe that such activities threaten
the integrity of their natural or cultural patrimony.
Article 47. Intellectual property rights with respect to products
or processes related to traditional knowledge associated with genetic
resources or derived products shall not be recognized if the access has not
taken place according to the provisions of this Act.
TECHNOLOGY DEVELOPMENT AND TRANSFER
Article 48. The State shall promote and support the development of
national sustainable technologies for the study, use and improvement of
autochthonous species, lineages and varieties, and shall support the
traditional uses and practices of local communities and indigenous
Sole paragraph. For the purposes of this article, the State shall
promote the survey and evaluation of national and traditional
Article 49. The use of foreign biotechnologies will be permitted,
whenever these comply with this Act and with other regulations on
biosafety, and the interested company takes full responsibility for any
damage to health, the environment or traditional cultures.
Article 50. Arrangements shall be set up to guarantee and
facilitate, for the national researchers and providers of genetic
resources, the access to and transfer of technologies that are relevant to
the conservation and sustainable use of biological diversity, or that use
genetic resources without harming the natural and cultural environment of
Article 51. In the case of technologies which are subject to
patents or other intellectual property rights, it shall be guaranteed that
the procedures of access and transfer of technology shall be effected with
adequate protection to such rights.
VIOLATIONS AND ADMINISTRATIVE AND CRIMINAL SANCTIONS
Article 52. The conducts and activities which violate the
provisions of this Act shall be punished with administrative and criminal
Sole paragraph. The administrative and criminal sanctions may be
cumulative, being independent from each other.
Article 53. As to the violations defined in this Act, liability
falls upon the abettor, principal, director, administrator, member of the
board and of the technical agency, auditor, manager, representative, or
agent of a corporate body who, being informed or having the duty to be
informed of the criminal conduct of a third person, fails to prevent such a
conduct while having the power to act to prevent it.
Article 54. The corporate bodies shall be sentenced as provided in
this Act, whenever the violation is perpetrated upon decision taken by
their legal or contractual representatives, or by their collegiate bodies,
in the interest or to the benefit of such entities.
Sole paragraph. The liability of corporate bodies does not preclude
that of individuals, authors, co-authors, or persons participating in the
Article 55. Without prejudice to the provisions of this Act, the
agent, whether he is guilty or not, is required to compensate the damages
caused to the environment and to third parties affected by his actions.
Article 56. The acquisition and commercialization of genetic
resources and derived products, as well as their remittance abroad, and the
use of traditional knowledge, without the authorization stated in this Act,
constitute a crime subject to imprisonment of 1 (one) to 4 (four) years,
and a fine of up to 10,000 (ten thousand) times the daily fine stipulated
in the following article.
Sole paragraph. In the case of repeaters, the fine shall be doubled.
Article 57. The Executive Branch shall establish regulations
containing the cases for application of each one of the following sanctions
to the violations of this Act:
I - admonishment;
II - simple fine;
III - daily fine;
IV - seizure of the animals, products and subproducts of the fauna
and flora, instruments, tools, equipment, or vehicles of any nature used in
V - destruction or damaging of the product;
VI - suspension of commercialization of the product;
VII - embargo of the activity;
VIII - partial or total closure of the business, activity or undertaking;
IX - suspension of the legally required registration, license or
X - cancellation of the legally required registration, license or
XI - loss or reduction of fiscal incentives and benefits granted by
XII - loss or suspension of right to receive financing from
official funding agencies;
XIII - intervention in the business;
XIV - prohibition to enter into contracts with the Public
Administration for a period of up to three years.
Sole paragraph. The sanctions set forth by this article shall be
applied without prejudice to the applicable civil or criminal proceedings.
Article 58. The Executive Branch shall set forth regulations
concerning this Act within 180 (one hundred and eighty) days as of the day
of its publication.
Article 59. This Act shall come into force on the date of its
Article 60. All provisions to the contrary are hereby revoked.