Presidency of the Republic
General secretary
Sub-branch for Legal Affairs
LAW No. 13,123, OF MAY 20, 2015.
Regulates item II of § 1 and § 4 of art. 225 of the Federal Constitution, the
Article 1 veto message, Article 8 (j), Article 10 (c), Article 15 and §§ 3 and 4
of Article 16 of the Convention on Biological Diversity, promulgated by Decree
(See item II of § 1 and § 4 of Article 225 of the Constitution) No. 2,519, of March 16, 1998; provides for access to genetic heritage,
(See Decree No. 2,519, of 1998) on the protection and access to associated traditional knowledge and on the
sharing benefits for conservation and sustainable use of biodiversity;
Term revokes Provisional Measure No. 2,186-16, of August 23, 2001; and gives others
measures.
THE PRESIDENT OF THE REPUBLIC Let me know that the National Congress decrees and I sanction the following Law:
CHAPTER I
GENERAL PROVISIONS
Article 1 This Law provides for assets, rights and obligations relating to:
I - access to the country's genetic heritage, a common use of the people found in in situ conditions, including domesticated species and populations
spontaneous, or maintained in ex situ conditions, provided that it is found in in situ conditions in the national territory, on the continental shelf, in the territorial sea and in the
exclusive economic zone;
II - traditional knowledge associated with genetic heritage, relevant to the conservation of biological diversity, the integrity of the country's genetic heritage
and the use of its components;
III - access to technology and technology transfer for the conservation and use of biological diversity;
IV - the economic exploitation of finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge;
V - fair and equitable sharing of benefits derived from the economic exploitation of finished products or reproductive material arising from access to heritage
genetic or associated traditional knowledge, for conservation and sustainable use of biodiversity;
VI - the remittance abroad of part or all of organisms, living or dead, of animal, vegetable, microbial or other species, which are
intended for access to genetic heritage; and
VII - the implementation of international treaties on genetic heritage or associated traditional knowledge approved by the National Congress and
promulgated.
§ 1 Access to genetic heritage or associated traditional knowledge will be made without prejudice to the material or immaterial property rights that
focus on genetic heritage or associated traditional knowledge accessed or the place of its occurrence.
§ 2 The access to the genetic heritage existing on the continental shelf will comply with the provisions of Law 8,617, of January 4, 1993.
Art. 2 In addition to the concepts and definitions contained in the Convention on Biological Diversity - CDB, promulgated by Decree No. 2,519, of March 16,
1998, the following are considered for the purposes of this Law:
I - genetic heritage - information of genetic origin of plant, animal, microbial or other species, including substances originating from
the metabolism of these living beings;
II - associated traditional knowledge - information or practice of the indigenous population, traditional community or traditional farmer about properties or
direct or indirect uses associated with genetic heritage;
III - associated traditional knowledge of non-identifiable origin - associated traditional knowledge in which there is no possibility of linking its origin
at least an indigenous population, traditional community or traditional farmer;
IV - traditional community - culturally differentiated group that recognizes itself as such, has its own form of social organization and occupies and uses territories and
natural resources as a condition for their cultural, social, religious, ancestral and economic reproduction, using knowledge, innovations and practices generated and
transmitted by tradition;
V - traditional associated knowledge provider - indigenous population, traditional community or traditional farmer who owns and provides the information
on associated traditional knowledge for access;
VI - prior informed consent - formal consent, previously granted by an indigenous population or traditional community according to their uses,
community customs and traditions or protocols;
VII - community protocol - procedural norm for indigenous peoples, traditional communities or traditional farmers that establishes, according to their
uses, customs and traditions, the mechanisms for accessing associated traditional knowledge and the sharing of benefits referred to in this Law;
VIII - access to genetic heritage - research or technological development carried out on a sample of genetic heritage;
IX - access to associated traditional knowledge - technological research or development carried out on traditional knowledge associated with heritage
that allows or facilitates access to genetic heritage, even if obtained from secondary sources such as fairs, publications, inventories, films, articles
scientific records, registers and other forms of systematization and registration of associated traditional knowledge;
X - research - activity, experimental or theoretical, carried out on genetic heritage or associated traditional knowledge, with 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
observable phenomena and facts;
XI - technological development - systematic work on genetic heritage or associated traditional knowledge, based on procedures
obtained by research or practical experience, carried out with the aim of developing new materials, products or devices, improving or
develop new processes for economic exploration;
XII - registration of access or remittance of genetic heritage or associated traditional knowledge - mandatory declaratory instrument of
access or remittance of genetic heritage or associated traditional knowledge;
XIII - remittance - transfer of a sample of genetic heritage to an institution located outside the country with the purpose of access, in which the responsibility
the sample is transferred to the recipient;
XIV - authorization of access or remittance - administrative act that allows, under specific conditions, access to genetic heritage or knowledge
associated traditional and remittance of genetic heritage;
XV - user - natural or legal person who accesses genetic heritage or associated traditional knowledge or economically exploits the product
finished or reproductive material from access to genetic heritage or associated traditional knowledge;
XVI - finished product - product whose nature does not require any type of additional production process, arising from access to genetic heritage or to
associated traditional knowledge, in which the component of genetic heritage or associated traditional knowledge is one of the main elements of
adding value to the product, being able to be used by the end consumer, whether natural or legal person;
XVII - intermediate product - product whose nature is to be used in the production chain, which will add it to its production process, as an input,
excipient and raw material, for the development of another intermediate product or finished product;
XVIII - main elements of adding value to the product - elements whose presence in the finished product is decisive for the existence of the characteristics
functional or for the formation of market appeal;
XIX - product notification - declaratory instrument that precedes the beginning of the activity of economic exploitation of finished product or reproductive material
arising from access to genetic heritage or associated traditional knowledge, in which the user declares compliance with the requirements of this Law and indicates the
benefit sharing modality, when applicable, to be established in the benefit sharing agreement;
XX - benefit sharing agreement - legal instrument that qualifies the parties, the object and the conditions for sharing benefits;
XXI - sectoral agreement - contractual act signed between the government and users, with a view to fair and equitable sharing of benefits
arising from economic exploitation arising from access to genetic heritage or associated traditional knowledge of unidentifiable origin;
XXII - certificate of regularity of access - administrative act by which the competent body declares that access to genetic heritage or knowledge
traditional partner fulfilled the requirements of this Law;
XXIII - material transfer term - instrument signed between sender and recipient for shipment abroad of one or more samples containing
genetic heritage accessed or available for access, which indicates, when applicable, whether there was access to associated traditional knowledge and which establishes the
commitment to benefit sharing according to the rules provided for in this Law;
XXIV - agricultural activities - activities of production, processing and commercialization of food, beverages, fibers, energy and planted forests;
XXV - in situ conditions - conditions in which genetic heritage exists in natural ecosystems and habitats and, in the case of domesticated or
cultivated, in environments where they have naturally developed their own distinctive characteristics, including those that form spontaneous populations;
XXVI - domesticated or cultivated species - species whose evolutionary process has influenced human beings to meet their needs;
XXVII - ex situ conditions - conditions in which the genetic heritage is kept out of its natural habitat;
XXVIII - spontaneous population - population of species introduced into the national territory, even if domesticated, capable of self-perpetuating
naturally in Brazilian ecosystems and habitats;
XXIX - reproductive material - material for plant propagation or animal reproduction of any genus, species or crop from sexual reproduction
or asexual;
XXX - sending a sample - sending a sample containing genetic heritage for the provision of services abroad as part of research or
technological development in which the responsibility for the sample lies with those who perform access in Brazil;
XXXI - traditional farmer - natural person who uses traditional local or creole varieties or locally adapted or creole breeds and maintains and conserves
genetic diversity, including family farmers;
XXXII - traditional local or Creole variety - variety from species that occurs in situ or maintained in ex situ condition, composed of
group of plants within a taxon at the lowest known level, with genetic diversity developed or adapted by indigenous population, community
traditional or traditional farmer, including natural selection combined with human selection in the local environment, which is not substantially similar to cultivars
commercial; and
XXXIII - locally adapted or Creole breed - breed originating from a species that occurs in situ or maintained in ex situ condition, represented by
group of animals with genetic diversity developed or adapted to a specific ecological niche and formed from natural selection or selection carried out
adapted by indigenous population, traditional community or traditional farmer.
Single paragraph. Part of the genetic heritage existing in the national territory is considered, for the purposes of this Law, the microorganism that has been isolated to
from substrates in the national territory, the territorial sea, the exclusive economic zone or the continental shelf.
Art. 3 The access to the genetic heritage existing in the country or to traditional associated knowledge for research or technological development purposes and to
economic exploitation of finished product or reproductive material arising from this access will only be carried out upon registration, authorization or notification, and
will be subject to inspection, restrictions and benefit sharing under the terms and conditions established in this Law and its regulation.
Single paragraph. The Union is responsible for managing, controlling and inspecting the activities described in the caput, pursuant to the provisions of item XXIII of
caput of art. 7 of Complementary Law No. 140, of December 8, 2011.
Art. 4 This Law does not apply to human genetic heritage.
Art. 5 Access to genetic heritage and associated traditional knowledge is prohibited for practices harmful to the environment, cultural reproduction and
human health and the development of biological and chemical weapons.
CHAPTER II
INSTITUTIONAL COMPETENCES AND POWERS
Art. 6 The Genetic Heritage Management Council - CGen, a deliberative collegiate body, is created within the scope of the Ministry of the Environment.
normative, consultative and appeal, responsible for coordinating the development and implementation of policies for the management of access to genetic heritage and
associated traditional knowledge and benefit sharing, formed by representation of federal public administration bodies and entities that hold
competence over the various actions covered by this Law with a maximum participation of 60% (sixty percent) and the representation of civil society in at least
40% (forty percent) of the members, ensuring parity between:
I - business sector;
II - academic sector; and
III - indigenous populations, traditional communities and traditional farmers.
§ 1º CGen is also responsible for:
I - establish:
a) technical standards;
b) guidelines and criteria for drawing up and complying with the benefit-sharing agreement;
c) criteria for the creation of a database for recording information on genetic heritage and associated traditional knowledge;
II - monitor, in conjunction with federal agencies, or through an agreement with other institutions, the activities of:
a) access and shipment of a sample containing the genetic heritage; and
b) access to associated traditional knowledge;
III - decide on:
a) the authorizations referred to in item II of § 3 of art. 13;
b) the accreditation of a national institution that maintains an ex situ collection of samples containing the genetic heritage; and
c) the accreditation of a national institution to be responsible for the creation and maintenance of the database referred to in item IX;
IV - certify the regularity of access to genetic heritage or associated traditional knowledge referred to in Chapter IV of this Law;
V - register the receipt of the notification of the finished product or reproductive material and the presentation of the benefit sharing agreement, under the terms of art.
16;
VI - promote public debates and consultations on the topics covered by this Law;
VII - function as a higher level of appeal in relation to the decision of an accredited institution and the acts resulting from the application of this Law, in the form of
regulation;
VIII - establish guidelines for the application of resources destined to the National Fund for the Sharing of Benefits - FNRB, provided for in art. 30, as
benefit sharing;
IX - create and maintain a relative database:
a) records of access to genetic heritage or associated traditional and referral knowledge;
b) authorizations for access to genetic heritage or associated traditional and referral knowledge;
c) the instruments and terms of material transfer;
d) the ex situ collections of accredited institutions that contain samples of genetic heritage;
e) notifications of finished product or reproductive material;
f) benefit sharing agreements;
g) certificates of regularity of access;
X - scienti fi c federal organs for the protection of the rights of indigenous populations and traditional communities on the registration in the register of access to
associated traditional knowledge;
XI - (VETOED); and
XII - approve its internal regulations.
§ 2nd Regulation will provide for the composition and operation of CGen.
§ 3 CGen will create Thematic and Sectorial Chambers, with the equal participation of the Government and civil society, which is represented by the sectors
business, academic and representatives of indigenous peoples, traditional communities and traditional farmers, to support plenary decisions.
Art. 7 The federal public administration will make available to CGen, in accordance with the regulation, the information necessary for the traceability of activities
arising from access to genetic heritage or associated traditional knowledge, including those related to economic exploitation arising from such access.
CHAPTER III
OF ASSOCIATED TRADITIONAL KNOWLEDGE
Art. 8 The traditional knowledge associated with the genetic heritage of indigenous populations, traditional communities or other communities is protected by this Law.
traditional farmer against illegal use and exploitation.
§ 1 The State recognizes the right of indigenous populations, traditional communities and traditional farmers to participate in decision-making, in the
national level, on issues related to the conservation and sustainable use of their traditional knowledge associated with the genetic heritage of the country, in
pursuant to this Law and its regulations.
§ 2 The traditional knowledge associated with the genetic heritage covered by this Law is part of the Brazilian cultural heritage and may be deposited in a bank
data, as provided by CGen or specific legislation.
§ 3 Are ways of recognizing the associated traditional knowledge, among others:
I - scientific publications;
II - records in registers or databases; or
III - cultural inventories.
§ 4 The exchange and dissemination of genetic heritage and associated traditional knowledge practiced among themselves by indigenous populations, the community
traditional farmer or traditional farmer for his own benefit and based on his uses, customs and traditions are exempt from the obligations of this Law.
Art. 9 Access to associated traditional knowledge of identifiable origin is conditional on obtaining prior informed consent.
§ 1 The proof of prior informed consent may occur, at the discretion of the indigenous population, the traditional community or the traditional farmer,
following instruments, in the form of the regulation:
I - signature of the prior consent form;
II - audiovisual record of consent;
III - opinion of the competent official body; or
IV - adhesion as provided for in a community protocol.
§ 2 Access to associated traditional knowledge of non-identifiable origin does not depend on prior informed consent.
§ 3 Access to the genetic heritage of a local or Creole traditional variety or to the locally adapted or Creole breed for agricultural activities comprises the
access to unidentified associated traditional knowledge that gave rise to the variety or race and does not depend on prior consent from the indigenous population,
the traditional community or the traditional farmer who creates, develops, owns or preserves the variety or breed.
Art. 10. To indigenous populations, traditional communities and traditional farmers who create, develop, retain or retain knowledge
associated traditional rights are guaranteed:
I - having recognized his contribution to the development and conservation of genetic heritage, in any form of publication, use, exploitation and
disclosure;
II - have indicated the origin of access to associated traditional knowledge in all publications, uses, explorations and disclosures;
III - perceive benefits from economic exploitation by third parties, directly or indirectly, of associated traditional knowledge, under the terms of this Law;
IV - participate in the decision-making process on issues related to access to associated traditional knowledge and benefit sharing
resulting from this access, in the form of the regulation;
V - use or freely sell products containing genetic heritage or associated traditional knowledge, subject to the provisions of Laws no.
9,456, of April 25, 1997, and 10,711, of August 5, 2003; and
VI - to conserve, manage, store, produce, exchange, develop, improve reproductive material containing genetic heritage or traditional knowledge
associated.
§ 1 For the purposes of this Law, any traditional knowledge associated with genetic heritage will be considered collective in nature, even if only a
individual of indigenous population or traditional community detains him.
§ 2 The genetic heritage maintained in ex situ collections in national institutions managed with public resources and the information associated with it may be
accessed by indigenous peoples, traditional communities and traditional farmers, in the form of the regulation.
CHAPTER IV
ACCESS, SHIPPING AND ECONOMIC EXPLORATION
Art. 11. The following activities are subject to the requirements of this Law:
I - access to genetic heritage or associated traditional knowledge;
II - sending samples of genetic heritage abroad; and
III - economic exploitation of finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge
carried out after the validity of this Law.
§ 1 Access to genetic heritage or associated traditional knowledge by a foreign natural person is prohibited.
§ 2 The remittance of a sample of genetic heritage abroad depends on the signature of the material transfer term, as provided by CGen.
Art. 12. The following activities must be registered:
I - access to genetic heritage or associated traditional knowledge within the country carried out by a natural or legal person, national, public or private;
II - access to genetic heritage or associated traditional knowledge by a legal entity based abroad associated with a national research institution
scientific and technological, public or private;
III - access to genetic heritage or associated traditional knowledge carried out abroad by a natural or legal person, whether national, public or private;
IV - remittance of a sample of genetic heritage abroad for the purpose of access, in the hypotheses of items II and III of this caput; and
V - sending of a sample containing genetic heritage by a national legal entity, public or private, to provide services abroad as part of
technological research or development.
§ 1 The registration referred to in this article will have its operation defined in regulation.
§ 2 The registration must be carried out prior to the shipment, or the application for any intellectual property right, or the commercialization of the
intermediate product, or the dissemination of results, final or partial, in scientific or communication media, or the notification of finished product or material
reproductive system developed as a result of access.
§ 3 The information contained in the database referred to in item IX of § 1 of art. 6, except for those that may harm the
scientific or technological research or development activities or the commercial activities of third parties, and this information may be made available through
user authorization.
Art. 13. The following activities may, at the discretion of the Union, be carried out with prior authorization, in accordance with the regulation:
I - access to genetic heritage or associated traditional knowledge in an area essential to national security, which will take place after the consent of the
National Defense Council;
II - access to genetic heritage or associated traditional knowledge in Brazilian jurisdictional waters, on the continental shelf and in the economic zone
exclusive, which will take place after the consent of the maritime authority.
§ 1 Access and remittance authorizations can be requested together or separately.
§ 2 The authorization to send a genetic heritage sample abroad transfers the responsibility of the sample or material sent to the
recipient.
§ 3 (VETOED).
§ 4 (VETOED).
Art. 14. The ex situ conservation of a sample of the genetic heritage found in the in situ condition should preferably be carried out in the national territory.
Art. 15. The authorization or registration for sending a sample of the genetic heritage abroad depends on the information on the intended use, observing the
Regulation requirements.
Art. 16. For the economic exploitation of finished product or reproductive material arising from access to genetic heritage or traditional knowledge
associated will be required:
I - notification of the finished product or reproductive material to CGen; and
II - the presentation of the benefit sharing agreement, except for the provisions of § 5 of art. 17 and in § 4 of art. 25.
§ 1 The type of benefit sharing, monetary or non-monetary, must be indicated at the time of notification of the finished product or material
reproductive health resulting from access to genetic heritage or associated traditional knowledge.
§ 2 The benefit sharing agreement must be presented within 365 (three hundred and sixty-five) days from the time of product notification.
finished or reproductive material, as provided for in Chapter V of this Law, except in cases involving traditional associated knowledge of origin
identifiable.
CHAPTER V
BENEFIT BREAKDOWN
Art. 17. The benefits resulting from the economic exploitation of finished product or reproductive material arising from access to the genetic heritage of species
found in situ conditions or associated traditional knowledge, even if produced outside the country, will be shared in a fair and equitable manner,
in the case of the finished product the component of genetic heritage or associated traditional knowledge must be one of the main elements of aggregation of
value, in accordance with the provisions of this Law.
§ 1 The manufacturer of the finished product or the producer of reproductive material will be subject to the sharing of benefits, regardless of who
has previously accessed.
§ 2 The manufacturers of intermediate products and process developers from access to genetic heritage or traditional knowledge
throughout the production chain will be exempt from the benefit sharing obligation.
§ 3 When a single finished product or reproductive material is the result of different accesses, these will not be considered cumulatively for the
calculation of benefit sharing.
§ 4 The licensing, transfer or permission to use any form of intellectual property right over the finished product,
reproductive process or material arising from access to genetic heritage or traditional knowledge associated by third parties are characterized as exploitation
economic exemption from the benefit-sharing obligation.
§ 5 The following are exempt from the benefit sharing obligation, under the terms of the regulation:
I - micro-enterprises, small businesses, individual micro-entrepreneurs, as provided for in Complementary Law No. 123, of December 14
2006; and
II - traditional farmers and their cooperatives, with annual gross revenue equal to or less than the maximum limit established in item II of art. 3rd of the Law
Complementary nº 123, of December 14, 2006.
§ 6 In the case of access to the associated traditional knowledge by the persons provided for in § 5, the holders of that knowledge will be benefited in the
terms of art. 33.
§ 7 If the finished product or reproductive material has not been produced in Brazil, the importer, subsidiary, controlled, affiliated, linked or
commercial representative of the foreign producer in national territory or in the territory of countries with which Brazil has an agreement with this end responds
jointly with the manufacturer of the finished product or reproductive material for benefit sharing.
§ 8 In the absence of access to information essential to the determination of the basis for calculating the sharing of benefits in a timely manner, in the cases
referred to in paragraph 7, the Union will arbitrate the value of the calculation base according to the best information available, considering the percentage provided for in this Law or in agreement
sectorial, guaranteed the contradictory.
§ 9 The Union will establish by decree the List of Classification of Benefit Sharing, based on the Common Mercosur Nomenclature - NCM.
§ 10. (VETOED).
Art. 18. The benefits resulting from the economic exploitation of a product arising from access to genetic heritage or associated traditional knowledge for
agricultural activities will be shared on the commercialization of reproductive material, even if access or economic exploitation is through individuals
or subsidiary, controlled, affiliated, contracted, outsourced or linked legal entity, respecting the provisions of § 7 of art. 17.
§ 1 The benefit sharing, provided for in the caput, must be applied to the last link in the productive chain of reproductive material, with the remaining links being exempt.
§ 2 In the case of economic exploitation of reproductive material arising from access to genetic heritage or associated traditional knowledge for the purposes of
agricultural activities and destined exclusively to the generation of finished products in production chains that do not involve agricultural activity, the
benefits will only occur on the economic exploitation of the finished product.
§ 3 The economic exploitation of finished product or reproductive material from access to the genetic heritage of
species introduced into the national territory by human action, even if domesticated, except:
I - those that form spontaneous populations that have acquired their own distinctive characteristics in the country; and
II - traditional local or Creole variety or locally adapted or Creole breed.
Art. 19. The sharing of benefits resulting from the economic exploitation of finished product or reproductive material arising from access to genetic heritage or
associated traditional knowledge may consist of the following modalities:
I - monetary; or
II - non-monetary, including, among others:
a) projects for the conservation or sustainable use of biodiversity or for the protection and maintenance of knowledge, innovations or practices of populations
indigenous, traditional communities or traditional farmers, preferably at the place of occurrence of the species in situ or
sample when the original location cannot be specified;
b) technology transfer;
c) availability of a product in the public domain, without protection by intellectual property rights or technological restrictions;
d) licensing of products free of charge;
e) training of human resources on topics related to the conservation and sustainable use of genetic heritage or associated traditional knowledge;
and
f) free distribution of products in social interest programs.
§ 1 In the case of access to genetic heritage, the option for one of the benefit sharing modalities provided for in the caput is at the user's discretion.
§ 2nd Act of the Executive Branch will regulate the form of sharing benefits of the non-monetary modality in cases of access to genetic heritage.
§ 3 The sharing of non-monetary benefits corresponding to the transfer of technology may be carried out, among other ways, through:
I - participation in research and technological development;
II - exchange of information;
III - exchange of human, material or technology resources between a national scientific and technological research institution, public or private, and a research institution.
research based abroad;
IV - consolidation of research and technological development infrastructure; and
V - establishment of a technology-based joint venture.
§ 4 (VETOED).
Art. 20. When the chosen modality is the sharing of monetary benefits resulting from the economic exploitation of finished product or material
reproductive system resulting from access to genetic heritage, a portion of 1% (one percent) of the annual net revenue from economic
except for the hypothesis of reduction to 0.1 (one tenth) per sectorial agreement provided for in art. 21.
Art. 21. In order to guarantee the competitiveness of the contemplated sector, the Union may, at the request of the interested party, according to the regulation, enter into an agreement
sector that allows to reduce the value of the monetary benefit sharing to up to 0.1% (one tenth percent) of the annual net revenue obtained with the exploration
economic value of the finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge of non-origin
identifiable.
Single paragraph. To support the conclusion of a sectoral agreement, the official bodies for the defense of the rights of indigenous populations and traditional communities
may be heard, under the terms of the regulation.
Art. 22. In the modalities of sharing non-monetary benefits corresponding to subparagraphs a, e and f of item II of the caput of art. 19, the breakdown of
The benefits should be equivalent to 75% (seventy-five percent) of the amount foreseen for the monetary modality, according to the criteria defined by CGen.
Single paragraph. CGen may define criteria or parameters for results or effectiveness that users must meet, replacing the
cost foreseen in the caput for non-monetary benefit sharing.
Art. 23. When the finished product or reproductive material comes from access to associated traditional knowledge of non-identifiable origin, Art.
allocation resulting from the use of this knowledge shall be made in the manner provided for in item I of the caput of art. 19 and in an amount corresponding to the
established in arts. 20 and 21 of this Law.
Art. 24. When the finished product or reproductive material comes from access to associated traditional knowledge that is of identifiable origin, the
associated traditional knowledge provider will be entitled to receive benefits under benefit sharing agreement.
§ 1 The allocation between user and provider will be negotiated in a fair and equitable manner between the parties, taking into account parameters of clarity, loyalty and
transparency in the agreed clauses, which should indicate conditions, obligations, types and duration of short, medium and long term benefits.
§ 2 The distribution with the other holders of the same associated traditional knowledge will take place in the monetary modality, carried out through the Fund
National for Benefit Sharing - FNRB.
§ 3 The portion due by the user for the sharing of benefits provided for in § 2, to be deposited in the National Fund for the Sharing of Benefits - FNRB,
correspond to half of that provided for in art. 20 of this Law or defined in a sectoral agreement.
§ 4 The sharing of benefits referred to in § 3 does not depend on the number of other holders of associated traditional knowledge accessed.
§ 5 In any case, it is presumed, in an absolute manner, the existence of other holders of the same associated traditional knowledge.
Art. 25. The benefit-sharing agreement must clearly indicate and qualify the parties, who will be:
I - in the case of economic exploitation of the finished product or reproductive material arising from access to genetic heritage or traditional knowledge
associate of unidentifiable origin:
a) the Union, represented by the Ministry of the Environment; and
b) one who economically exploits finished product or reproductive material from access to genetic heritage or traditional knowledge
associate of unidentifiable origin; and
II - in the case of economic exploitation of the finished product or reproductive material arising from access to associated traditional knowledge of origin
identifiable:
a) the associated traditional knowledge provider; and
b) one who economically exploits a finished product or reproductive material from access to associated traditional knowledge.
§ 1 In addition to the Benefit Sharing Agreement, the user must deposit the amount stipulated in § 3 of art. 24 in the National Fund for the
of Benefits - FNRB when exploring economically finished product or reproductive material from access to associated traditional knowledge of origin
identifiable.
§ 2 In the case of economic exploitation of the finished product or reproductive material arising from access to genetic heritage or traditional knowledge
associate of non-identifiable origin, sectoral agreements may be signed with the Union with the objective of sharing benefits, according to the regulation.
§ 3 The sharing of benefits resulting from the economic exploitation of finished products or reproductive material arising from access to knowledge
traditional associate exempts the user from sharing benefits related to genetic heritage.
§ 4 The monetary benefit sharing referred to in item I of the caput may, at the user's discretion, be deposited directly in the National Fund for the
Benefit Sharing - FNRB, without the need to enter into a benefit sharing agreement, in accordance with the regulations.
Art. 26. Essential clauses of the benefit sharing agreement, without prejudice to others that may be established in regulation, are those that
provide on:
I - products subject to economic exploitation;
II - duration term;
III - benefit sharing method;
IV - rights and responsibilities of the parties;
V - intellectual property right;
VI - termination;
VII - penalties; and
VIII - forum in Brazil.
CHAPTER VI
ADMINISTRATIVE SANCTIONS
Art. 27. An administrative infraction against genetic heritage or traditional knowledge associated with any action or omission that violates the
rules of this Law, in the form of the regulation.
§ 1 Without prejudice to the applicable criminal and civil sanctions, administrative infractions will be punished with the following sanctions:
I - warning;
II - fine;
III - seizure:
a) samples containing the genetic heritage accessed;
b) the instruments used to obtain or process the genetic heritage or associated traditional knowledge accessed;
c) products derived from access to genetic heritage or associated traditional knowledge; or
d) products obtained from information on associated traditional knowledge;
IV - temporary suspension of the manufacture and sale of the finished product or reproductive material derived from access to genetic heritage or knowledge
traditional associated until regularization;
V - embargo of the specific activity related to the infraction;
VI - partial or total interdiction of the establishment, activity or enterprise;
VII - suspension of certificate or authorization referred to in this Law; or
VIII - cancellation of certificate or authorization referred to in this Law.
§ 2 For the imposition and gradation of administrative sanctions, the competent authority shall observe:
I - the gravity of the fact;
II - the offender's record of compliance with the legislation regarding genetic heritage and associated traditional knowledge;
III - recurrence; and
IV - the economic situation of the offender, in the case of a fine.
§ 3 The sanctions provided for in § 1 may be applied cumulatively.
§ 4 The samples, products and instruments referred to in item III of § 1 will have their destination defined by CGen.
§ 5 The fine referred to in item II of § 1 will be arbitrated by the competent authority, for an infraction, and may vary:
I - from R $ 1,000.00 (one thousand reais) to R $ 100,000.00 (one hundred thousand reais), when the infraction is committed by a natural person; or
II - from R $ 10,000.00 (ten thousand reais) to R $ 10,000,000.00 (ten million reais), when the infraction is committed by a legal entity, or with its tender.
§ 6 - Recurrence is verified when the agent commits a new infraction within up to 5 (five) years from the final decision of the administrative decision
who has convicted you of a previous offense.
§ 7 The regulation shall provide for the administrative procedure for the application of the sanctions referred to in this Law, ensuring the right to ample defense and
contradictory.
Art. 28. The competent federal agencies will exercise inspection, interception and seizure of samples that contain the accessed genetic heritage,
products or reproductive material arising from access to genetic heritage or associated traditional knowledge, when access or economic exploitation
has been in disagreement with the provisions of this Law and its regulations.
Art. 29. (VETOED).
CHAPTER VII
THE NATIONAL BENEFIT SHARING FUND AND THE NATIONAL BENEFIT SHARING PROGRAM
Art. 30. The National Fund for the Sharing of Benefits - FNRB is established, of a financial nature, linked to the Ministry of the Environment, with the
objective of valuing the genetic heritage and associated traditional knowledge and promoting its use in a sustainable manner.
Art. 31. The Executive Power will provide in regulation on the composition, organization and functioning of the FNRB Management Committee.
Single paragraph. The management of monetary resources deposited in the FNRB for indigenous populations, traditional communities and farmers
will take place with your participation, in the form of the regulation.
Art. 32. The FNRB's revenues are:
I - appropriations enshrined in the annual budget law and their additional credits;
II - donations;
III - amounts collected with the payment of administrative fines applied due to non-compliance with this Law;
IV - external financial resources arising from contracts, agreements or covenants, especially reserved for the Fund's purposes;
V - contributions made by users of genetic heritage or associated traditional knowledge to the National Benefit Sharing Program;
VI - amounts arising from the sharing of benefits; and
VII - other revenues that may be allocated to it.
§ 1 The monetary resources deposited in the FNRB resulting from the economic exploitation of finished product or reproductive material arising from access to
associated traditional knowledge will be used exclusively for the benefit of holders of associated traditional knowledge.
§ 2 The monetary resources deposited in the FNRB resulting from the economic exploitation of finished product or reproductive material arising from access to
genetic heritage from ex situ collections will be partially allocated for the benefit of these collections, in the form of the regulation.
§ 3 The FNRB may establish cooperation instruments, including with States, Municipalities and the Federal District.
Art. 33. The National Benefit Sharing Program - PNRB is hereby established, with the purpose of promoting:
I - conservation of biological diversity;
II - recovery, creation and maintenance of ex situ collections of samples of genetic heritage;
III - prospection and training of human resources associated with the use and conservation of genetic heritage or associated traditional knowledge;
IV - protection, promotion of the use and enhancement of associated traditional knowledge;
V - implementation and development of activities related to the sustainable use of biological diversity, its conservation and benefit sharing;
VI - fostering research and technological development associated with genetic heritage and associated traditional knowledge;
VII - survey and inventory of genetic heritage, considering the situation and the degree of variation of existing populations, including those in use
potential and, when feasible, assessing any threats to them;
VIII - support for the efforts of indigenous populations, traditional communities and traditional farmers in sustainable management and conservation of
genetic heritage;
IX - conservation of wild plants;
X - development of an efficient and sustainable ex situ and in situ conservation system and development and transfer of appropriate technologies for
this purpose with a view to improving the sustainable use of genetic heritage;
XI - monitoring and maintaining the viability, degree of variation and genetic integrity of collections of genetic heritage;
XII - adoption of measures to minimize or, if possible, eliminate threats to genetic heritage;
XIII - development and maintenance of the various cultivation systems that favor the sustainable use of genetic heritage;
XIV - elaboration and execution of Sustainable Development Plans for Traditional Populations or Communities; and
XV - other actions related to access to genetic heritage and associated traditional knowledge, according to the regulation.
Art. 34. The PNRB will be implemented through the FNRB.
CHAPTER VIII
TRANSITIONAL PROVISIONS ON FITNESS AND REGULARIZATION OF ACTIVITIES
Art. 35. The request for authorization or regularization of access and remittance of genetic heritage or associated traditional knowledge still in progress
on the date of entry into force of this Law, it must be reformulated by the user as a request for registration or authorization for access or remittance, as the case may be.
Art. 36. The term for the user to reformulate the authorization or regularization request referred to in art. 35 will be 1 (one) year from the date of availability
registration by CGen.
Art. 37. Within 1 (one) year, counting from the date the CGen makes the registration available, the user who performed the
as of June 30, 2000, the following activities in accordance with Provisional Measure No. 2,186-16, of August 23, 2001:
I - access to genetic heritage or associated traditional knowledge;
II - economic exploitation of finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge.
Single paragraph. For the purposes of the caput, the user, observing art. 44, must adopt one or more of the following measures, as appropriate:
I - register access to genetic heritage or associated traditional knowledge;
II - notify the finished product or the reproductive material object of economic exploitation, under the terms of this Law; and
III - share the benefits related to the economic exploitation carried out as of the date of entry into force of this Law, under the terms of Chapter V, except when the
made pursuant to Provisional Measure 2,186-16, of August 23, 2001.
Art. 38. Within 1 (one) year, counting from the date of the availability of the Register by CGen, the user who, between 30
June 2000 and the date of entry into force of this Law, carried out the following activities in disagreement with the legislation in force at the time:
I - access to genetic heritage or associated traditional knowledge;
II - access and economic exploitation of a product or process arising from access to genetic heritage or associated traditional knowledge, which
Provisional Measure No. 2,186-16, of August 23, 2001;
III - remittance of a sample of genetic heritage abroad; or
IV - disclosure, transmission or retransmission of data or information that integrate or constitute associated traditional knowledge.
§ 1 The regularization referred to in the caput is subject to the signing of the Term of Commitment.
§ 2 In the event of access to genetic heritage or associated traditional knowledge solely for the purposes of scientific research, the user will be
exempted from signing the Term of Commitment, being regularized through registration or authorization of the activity, as the case may be.
§ 3 The registration and authorization referred to in § 2 extinguish the enforceability of the administrative sanctions provided for in Provisional Measure No. 2,186-16, of 23
August 2001, and specified in arts. 15 and 20 of Decree No. 5,459, of June 7, 2005, provided that the offense was committed up to the day before the date of
entry into force of this Law.
§ 4 For the purpose of regularization at the National Institute of Industrial Property - INPI of patent applications filed during the term of the Measure
Provisional No. 2,186-16, dated August 23, 2001, the applicant must present the proof of registration or authorization referred to in this article.
Art. 39. The Term of Commitment will be signed between the user and the Union, represented by the Minister of State for the Environment.
Single paragraph. The Minister of State for the Environment may delegate the competence provided for in the caput.
Art. 40. The Term of Commitment shall provide, as the case may be:
I - registration or authorization to access or remit genetic heritage or associated traditional knowledge;
II - the notification of a product or process arising from access to genetic heritage or associated traditional knowledge, as provided for in Provisional Measure no.
2,186-16, of August 23, 2001; and
III - the sharing of benefits obtained, in the form of Chapter V of this Law, referring to the time in which the product developed after June 30, 2000 coming from
access to genetic heritage or associated traditional knowledge has been made available on the market, within the limit of up to 5 (five) years prior to the conclusion of the
Term of Commitment, subtracting the time spent on the process pending at CGen.
Art. 41. The signing of the Term of Commitment will suspend, in all cases:
I - the application of the administrative sanctions provided for in Provisional Measure No. 2,186-16, of August 23, 2001, and specified in arts. 16 to 19 and 21 to 24 of
Decree No. 5,459, of June 7, 2005, provided that the infraction was committed up to the day before the date of entry into force of this Law; and
II - the enforceability of sanctions applied based on Provisional Measure No. 2,186-16, of August 23, 2001, and arts. 16 to 19 and 21 to 24 of Decree nº
5,459, of June 7, 2005.
§ 1 The Term of Commitment referred to in this article constitutes an extrajudicial enforcement order.
§ 2 The prescription is suspended during the term of the Term of Commitment.
Paragraph 3 Completely fulfilled the obligations assumed in the Term of Commitment, as long as proven in a technical opinion issued by the Ministry of the Environment
Environment:
I - the administrative sanctions referred to in arts. 16, 17, 18, 21, 22, 23 and 24 of Decree No. 5,459, of June 7, 2005;
II - administrative sanctions applied based on arts. 16 to 18 of Decree No. 5,459, of June 7, 2005, will have their liability extinguished; and
III - the amounts of fines applied based on arts. 19, 21, 22, 23 and 24 of Decree No. 5,459, of June 7, 2005, monetarily updated, will be
reduced by 90% (ninety percent) of their value.
§ 4 The user who started the regularization process before the date of entry into force of this Law may, at his discretion, share the benefits in accordance with
with the terms of Provisional Measure 2,186-16, of August 23, 2001.
§ 5 The remaining balance of the amounts referred to in item III of § 3 will be converted, at the user's request, by the supervisory authority, into an obligation to
execute one of the non-monetary benefit sharing modalities, provided for in item II of the caput of art. 19 of this Law.
§ 6 The sanctions provided for in the caput will be immediately enforceable in the event of:
I - non-compliance with the obligations provided for in the Term of Commitment due to the fact of the infringer; or
II - practice of a new administrative infraction provided for in this Law during the term of the Term of Commitment.
§ 7 The extinction of the enforceability of the fine does not detract from the infraction already committed for the purpose of recidivism.
Art. 42. If there is interest of the parties, in order to resolve controversial issues and eventual administrative or judicial disputes, the following
regularization or adequacy rules, according to the hypothesis observed, even for cases prior to Provisional Measure No. 2,052, of June 29, 2000.
Single paragraph. In the event of a legal dispute, subject to the regularization or adequacy rules provided for in this Law, the Union is authorized to:
I - enter into an agreement or judicial transaction; or
II - give up the action.
Art. 43. CGen's acts and decisions regarding activities to access or remit genetic heritage or knowledge remain valid
traditional associate that generated products or processes in commercialization in the market and that were already subject to regularization before the entry into force of this Law.
§ 1º It will be up to CGen to register the authorizations already issued in the system.
Paragraph 2. The benefit-sharing agreements entered into prior to the entry into force of this Law will be valid for the period provided for therein.
Art. 44. Civil indemnities related to genetic heritage or associated traditional knowledge of which the Union is creditor are remitted.
Art. 45. The request for regularization provided for in this Chapter authorizes the continuation of the analysis of the application for industrial property rights in progress
competent body.
CHAPTER IX
FINAL DISPOSITIONS
Art. 46. Activities carried out on genetic heritage or associated traditional knowledge that are included in approved international agreements
by the National Congress and promulgated, when used for the purposes of the aforementioned international agreements, shall be made in accordance with the conditions
defined therein, maintaining the requirements contained therein.
Single paragraph. The benefit sharing provided for in the Nagoya Protocol does not apply to economic exploitation, for purposes of agricultural activity, of material
reproduction of species introduced into the country by human action until the entry into force of this Treaty.
Art. 47. The granting of intellectual property rights by the competent body over the finished product or reproductive material obtained from access to
genetic heritage or associated traditional knowledge is subject to registration or authorization, under the terms of this Law.
Art. 48. Within the scope of the Executive Branch, Technical Commissioned Functions, created by art. 58 of Provisional Measure No. 2,229-43, of September 6
2001, in the following amounts by level:
I - 33 (thirty-three) FCT-12; and
II - 53 (fifty-three) FCT-11.
Single paragraph. The following positions are created in the Superior Steering Group and Advisory Committee - DAS, destined to the unit that will exercise the
function of CGen's Executive Secretary:
I - 1 (one) DAS-5;
II - 3 (three) DAS-4; and
III - 6 (six) DAS-3.
Art. 49. This Law comes into force after 180 (one hundred and eighty) days have elapsed from the date of its official publication.
Art. 50. Provisional Measure 2,186-16, of August 23, 2001, is hereby revoked.
Brasília, May 20, 2015; 194th of Independence and 127th of the Republic.
DILMA ROUSSEFF
Jose Eduardo Cardozo
Joaquim Vieira Ferreira Levy
Kátia Abreu
Armando Monteiro
Nelson Barbosa
Tereza Campello
João Luiz Silva Ferreira
Aldo Rebelo
Francisco Gaetani
Patrus Ananias
Miguel Rossetto
Nilma Lino Gomes
This text does not replace the one published in the DOU of 14.5.2015
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