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Law No. 13123, Of 20 May 2015

Original Language Title: Lei nº 13.123, de 20 de maio de 2015

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LEI NO. 13,123, OF May 20, 2015

Regulamenta the inciso II of § 1º and § 4º of the art. 225 of the Federal Constitution, Article 1 (j) of Article 8 (c) of Article 10, Article 15 and § § 3rd and 4th of Article 16 of the Convention on Biological Diversity, promulgated by Decree No. 2,519 of March 16, 1998; provides on the access to genetic heritage, on protection and access to associated traditional knowledge and on the apportionment of benefits for conservation and sustainable use of biodiversity; repeal the Provisional Measure no 2.186-16, of August 23, 2001; and gives other arrangements.

THE CHAIRWOMAN OF THE REPUBLIC I do know that the National Congress decrees and I sanciono the following Law:

CHAPTER I

GENERAL PROVISIONS

Art. 1º This Act provides about goods, rights and relative obligations:

I-access to the genetic heritage of the Country, well of common use of the people found in conditions in situ, inclusive of domesticated species and spontaneous populations, or maintained under conditions ex situ, since found under conditions in situ no national territory, on the continental shelf, in the territorial sea and in the exclusive economic zone;

II-to the traditional knowledge associated with genetic heritage, relevant to the conservation of biological diversity, to the integrity of the country's genetic heritage and to utilization of its components;

III-to access to technology and technology transfer to the conservation and the use of biological diversity;

IV-to the economic exploitation of finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge;

V-to the fair and equitable allocation of the benefits derived from the economic exploitation of finished product or reproductive material from access to genetic heritage or to the associated traditional knowledge, for the conservation and sustainable use of biodiversity;

VI-to the consignment to the outside of part or of the whole of organisms, living or dead, of animal, plant, microbial or other species, which is intended for access to the genetic heritage; and

VII-to the implementation of international treaties on the heritage genetics or the associated traditional knowledge approved by the National Congress and promulgated.

§ 1º The access to genetic heritage or associated traditional knowledge will be effected without prejudice to the material or immaterial property rights that focus on the genetic heritage or on the associated traditional knowledge accessed or on the site of its occurrence.

§ 2º The access to the existing genetic heritage on the continental shelf will observe the provisions of Law No 8,617 of January 4, 1993.

Art. 2º In addition to the concepts and the definitions set out in the Convention on Biological Diversity-CDB, promulgated by Decree No. 2,519 of March 16, 1998, they consider themselves for the purposes of this Law:

I-genetic heritage-information of genetic origin of plant species, animals, microbials or species of other nature, including substances arising from the metabolism of these living beings;

II- traditional associated knowledge-information or practice of Indigenous population, traditional community or traditional farmer on the direct or indirect properties or uses associated with genetic heritage;

III-traditional associated source knowledge of non-identifiable origin-associated traditional knowledge in which not there is the possibility of linking its origin to at least one indigenous population, traditional community or traditional farmer;

IV-traditional culturally-differentiated group that recognizes itself as such, possesses own form of social organization and occupies and uses natural territories and resources as a condition for their cultural, social, religious, ancestral and economic reproduction, using knowledge, innovations and practices generated and transmitted by tradition;

V-provider of traditional knowledge associated-Indigenous population, traditional community or farmer traditional that holds and provides the information about associated traditional knowledge for access;

VI-informed prior consent-formal consent, previously granted by Indigenous population or traditional community according to their uses, customs and traditions or community protocols;

VII-community protocol-the procedure standard of populations indigenous, traditional communities or traditional farmers who establish, according to their uses, customs and traditions, the mechanisms for access to the associated traditional knowledge and the apportionment of benefits of which it treats this Law;

VIII-access to the genetic heritage-research or technological development carried out on sample of genetic heritage;

IX-access to the associated traditional knowledge-research or technological development carried out on traditional knowledge associated with genetic heritage that enables or facilitates access to genetic heritage, even if obtained from secondary sources such as fairs, publications, inventories, films, scientific articles, cadastros and other forms of systematization and the record of traditional knowledge associated;

X-research-activity, experimental or theoretical, carried out on the genetic heritage or associated traditional knowledge, with the aim of producing new knowledge, by means of a systematic process of building the knowledge it 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 on knowledge traditional associate, based on existing procedures, obtained by the research or practical experience, carried out with the aim of developing new materials, products or devices, perfecting or developing new processes for economic exploitation;

XII-enrollment of access or remittance of genetic heritage or of traditional associated knowledge-mandatory declaratory instrument of the access or remittance activities of genetic heritage or associated traditional knowledge;

XIII-shipment-sample transfer of genetic heritage to institution located outside the Country with the purpose of access, in which the responsibility on the sample is transferred to the addressee;

XIV-authorization of access or remittance-administrative act that allows, under specific conditions, access to genetic heritage or associated traditional knowledge and the referral of genetic heritage;

XV-user-natural or legal person who performs access to genetic heritage or associated traditional knowledge or economically exploits finished product or reproductive material arising from access to genetic heritage or to the associated traditional knowledge; XVI-finished product whose nature does not require any kind of additional productive process, arising from access to genetic heritage or associated traditional knowledge, in which the component of the genetic heritage or associated traditional knowledge is one of key elements of value aggregation to the product, being fit for use by the final consumer, whether this natural or legal person;

XVII-intermediate product-product whose nature is the use in productive chain, which will aggregate it in its productive process, in the condition of insumo, excipient and raw material, for the development of another intermediate product or finished product;

XVIII-core elements of value aggregation to the product-elements whose presence in the finished product is determinant for the existence of the functional characteristics or for the formation of the mercadological appeal;

XIX-notification of product-declaratory instrument preceding the commencement of the economic exploitation activity 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 distribution modality of benefits, where applicable, to be established in the benefits apportionment agreement;

XX-agreement apportionment of benefits-legal instrument that qualifies the parties, the object and the conditions for apportionment of benefits;

XXI-setorial agreement-act of contractual nature firmed between public power and users, taking in view of fair and equitable allocation of the benefits arising from economic exploitation arising from access to genetic heritage or to the associated traditional knowledge of non-identifiable origin; XXII-attestation of regularity of access-act administrative by which the competent body declares that access to genetic heritage or associated traditional knowledge has complied with the requirements of this Act;

XXIII-thermo-instrument transfer-struck between sender and recipient for outdoor shipping of one or more samples containing genetic heritage accessed or available for access, which indicates, when it is the case, whether there has been access to associated traditional knowledge and that establishes the commitment to apportionment of benefits in accordance with the rules laid down in this Act;

XXIV-agricultural activities-activities of production, processing and marketing of food, beverage, fibers, energy and forests planted;

XXV-conditions in situ -conditions in which the genetic heritage exists in ecosystems and natural habitats and, in the case of domesticated or cultivated species, in the means where they naturally have developed their distinctive characteristics of their own, including those that form spontaneous populations;

XXVI-domesticated or cultivated species-species in whose evolution process has influenced the be human to meet your needs;

XXVII-conditions ex situ -conditions in that the genetic heritage is kept out of their natural habitat;

XXVIII-population spontaneous-population of species introduced into the national territory, yet domesticated, capable of self-operating naturally in Brazilian ecosystems and habitats;

XXIX-reproductive material-material of plant propagation or animal reproduction of any genus, species or cultivation arising from sexuated or asexual reproduction; XXX-sample submission-sample submission containing genetic heritage for the provision of overseas services as part of research or technological development in which the responsibility about the sample is from who performs access in Brazil;

XXXI-traditional farmer- natural person who uses traditional local or creole varieties or breeds locally adapted or crunches and maintains and retains the genetic diversity, included the family farmer;

XXXII-traditional local or creoula-variety arising from species that occurs in in condition Situ or kept in condition ex situ, composed of group of plants within a taxon at the lowest known level, with genetic diversity developed or adapted by indigenous population, traditional community or traditional farmer, including natural selection combined with human selection in the local environment, which is not substantially similar to commercial cultivars; and

XXXIII-breed locally adapted or creoula-breed arising from species that occurs in in situ condition or kept in condition ex situ, represented by group of animals with genetic diversity developed or adapted to a particular ecological niche and formed from natural selection or selection carried out adapted by indigenous population, traditional community or traditional farmer.

Paragraph single. It is considered to be part of the existing genetic heritage in the national territory, for the purposes of this Law, the micro-organism that has been isolated from substrates from the national territory, the territorial sea, the exclusive economic zone or the continental shelf.

Art. 3º Access to the existing genetic heritage in the Country or to the associated traditional knowledge for research or technological development purposes and the economic exploitation of finished product or reproductive material arising from this access will only be performed upon enrollment, authorization or notification, and shall be subjected to surveillance, restrictions and apportionment of benefits under the terms and conditions set forth in this Act and in its regulation.

Paragraph single. They are of the competence of the Union the management, control and surveillance of the activities described in the caput, pursuant to the provisions of the inciso XXIII of the art caput. 7º of the Supplementary Law No. 140, of December 8, 2011.

Art. 4º This Law does not apply to human genetic patrimony.

Art. 5º It is vetoed access to genetic heritage and associated traditional knowledge for harmful practices to the environment, cultural reproduction and human health and to the development of biological and chemical weapons.

CHAPTER II

DAS COMPETENCIES AND INSTITUTIONAL ATTRIBUTIONS

Art. 6º It is created within the framework of the Ministry of the Environment the Board of Management of Genetic Heritage-CGen, collegiate body of deliberative, normative, advisory and recursal character, responsible for coordinating the elaboration and implementation of policies for the management of access to genetic heritage and associated traditional knowledge and benefits apportionment, formed by representation of organs and entities of the federal public administration that hold competence over the diverse actions of which it treats this Act with maximum participation of 60% (sixty percent) and the representation of civil society at a minimum of 40% (forty percent) of the members, ensured parity between:

I-business sector;

II-academic sector; and

III-indigenous populations, traditional communities and traditional farmers.

§ 1º Compete also to the CGen:

I-establish:

a) technical standards;

b) guidelines and criteria for elaboration and fulfillment of the benefits apportionment agreement;

c) criteria for database creation for the registration of information on genetic heritage and knowledge traditional associate;

II-accompany, in articulation with federal bodies, or upon convenium with other institutions, the activities of:

a) access and sample shipment that contain the genetic heritage; and

b) access to associated traditional knowledge;

III-deliberating on:

a) the authorizations of which it treats the inciso II of § 3º of the art. 13;

b) the national institution accreditation that maintains ex situ collection of samples containing the genetic heritage; and

c) the accreditation of national institution to be responsible for the creation and maintenance of the database of which it treats inciso IX;

IV-attest to the regularity of access to genetic heritage or to the associated traditional knowledge of which it treats Chapter IV of this Act;

V-record the receipt of the notification of the finished product or reproductive material and the presentation of the agreement of apportionment of benefits, in the terms of art. 16;

VI-promoting debates and public consultations on the topics of which it treats this Law;

VII-function as an upper instance of appeal in relation to the institution decision accredited and to the acts arising from the application of this Act, in the form of the Regulation;

VIII- establish guidelines for application of the resources intended for the National Fund for the Repartition of Benefits-FNRB, provided for in art. 30, in the title of apportionment of benefits;

IX-create and maintain relative database:

a) to the cadasters of access to genetic heritage or associated traditional knowledge and shipping;

b) to the entitlements of access to genetic heritage or to knowledge traditional associate and remittance;

c) to the instruments and terms of transfer of material;

d) to the ex situ collections of the accredited institutions containing samples of genetic heritage;

e) to the notifications of finished product or reproductive material;

f) to the benefits apportionment agreements;

g) to the attestates of regularity of access;

X-scientifying federal organs of protecting the rights of indigenous populations and traditional communities over the registration in enrollment of access to traditional associated knowledge;

XI-(VETADO); and

XII-approve your internal regiment.

§ 2º Regulation will have on the composition and functioning of the CGen.

§ 3º The CGen will create Thematic Chambers and Setorials, with the parity of the Government and civil society, being this represented by the business, academic, and representatives of indigenous populations, traditional communities and traditional farmers, to subsidize the decisions of the plenum.

Art. 7º The federal public administration will make available to the CGen, in the form of the regulation, the information necessary for the traceability of activities arising from access to genetic heritage or to the associated traditional knowledge, including the relating to the economic exploitation arising from that access.

CHAPTER III

OF THE ASSOCIATED TRADITIONAL KNOWLEDGE

Art. 8º Stay protected by this Law the traditional knowledge associated with the genetic heritage of indigenous people, of traditional community or of traditional farmer against the illicit use and exploitation.

§ 1º The State recognizes the right of indigenous people, from traditional communities and of traditional farmers to participate in decision making, nationwide, on matters related to the conservation and sustainable use of their traditional knowledge associated with the country's genetic heritage, pursuant to this Law and of your regulation.

§ 2º The traditional knowledge associated with the genetic patrimony of which treats this Law integrates the Brazilian cultural heritage and could be deposited in database, as we dispose of the CGen or specific legislation.

§ 3º Are forms of recognition of the associated traditional knowledge, among others:

I-scientific publications;

II-records in cadasters or databases; or

III-cultural inventories.

§ 4º The exchange and diffusion of genetic heritage and traditional knowledge associate practiced among themselves by indigenous populations, traditional community or traditional farmer for their own benefit and based on their uses, customs and traditions are exempt from the obligations of this Law.

Art. 9º Access to the associated traditional knowledge of identifiable origin is conditional on obtaining the informed prior consent.

§ 1º The substantiation of the informed prior consent may occur, at the discretion of the indigenous population, the traditional community or the traditional farmer, by the following instruments, in the form of the regulation:

I-signature of term of prior consent;

II-audiovisual record of consent;

III-opinion of the competent official organ; or

IV-adherence in the intended form in community protocol.

§ 2º The access to traditional associated knowledge of non-identifiable origin independs on informed prior consent.

§ 3º The access to the genetic heritage of traditional local or creole variety or the breed locally adapted or creole for agricultural activities comprises access to the unidentifiable traditional associated knowledge that has given rise to variety or race and does not depend on the prior consent of the indigenous population, the community traditional or from the traditional farmer who creates, develops, holds or retains variety or race.

Art. 10. To Indigenous populations, traditional communities and traditional farmers who create, develop, detain or retain traditional knowledge associated are guaranteed the rights to:

I-have recognized its contribution to the development and conservation of genetic heritage, in any form of publication, use, exploitation and dissemination;

II-having indicated the origin of access to the traditional knowledge associated in all publications, uses, explorations and disclosures;

III-perceive benefits by economic exploitation by third parties, directly or indirectly, of associated traditional knowledge, pursuant to this Act;

IV-participate in the decision making process on subjects related to access to knowledge traditional associate and the apportionment of benefits arising from that access, in the form of the regulation;

V-use or freely sell products containing genetic heritage or associated traditional knowledge, observed the devices of the Leis nos 9,456, April 25 of 1997, and 10,711, of August 5, 2003; and

VI-conserve, manejar, store, produce, exchange, develop, improve reproductive material that contains genetic heritage or associated traditional knowledge.

§ 1º For the purposes of this Law, any traditional knowledge associated with genetic heritage will be considered to be of a collective nature, yet only an individual of population indian or from traditional community detain you.

§ 2º Genetic heritage held in ex situ collections in national institutions managed with public resources and the associated information it will be able to be accessed by indigenous people, traditional communities and traditional farmers in the form of the regulation.

CHAPTER IV

OF ACCESS, SHIPPING, AND ECONOMIC EXPLOITATION

Art. 11. They become subject to the requirements of this Act the following activities:

I-access to heritage genetic or to the associated traditional knowledge;

II-shipment to the exterior of samples of genetic heritage; and

III-economic exploitation of finished product or material reproductive arising from access to genetic heritage or to the associated traditional knowledge carried out after the duration of this Law.

§ 1º It is vetted access to the genetic heritage or the traditional knowledge associated by foreign natural person.

§ 2º The shipment to the outside of the genetic heritage sample depends on the signature of the material transfer term, in the form predicted by the CGen.

Art. 12. The following activities should be enrolled:

I-access to genetic heritage or to the traditional knowledge associated within the Country carried out by natural or legal national, public or private legal person;

II-access to the genetic heritage or traditional knowledge associated by legal person based abroad associated with the national scientific research institution and technological, public or private;

III-access to genetic heritage or knowledge traditional associate held abroad by natural or legal national, public or private legal person;

IV-shipment of sample of genetic heritage to the outside with the purpose of access, in the hypotheses of the incisos II and III of this caput; and

V-sending sample that contains genetic heritage by national, public or private legal person, for provision of services abroad as a part of research or technological development.

§ 1º The enrollment of which it treats this article will have its functioning defined in regulation.

§ 2º The enrollment is to be carried out in advance to the shipment, or to the requirement of any intellectual property right, or the marketing of the intermediary product, or to the disclosure of the results, final or partial, in scientific or communication means, or to the notification of finished product or reproductive material developed as a result of access.

§ 3º Are public the information constant from the database of which it treats the inciso IX of the § 1º of the art. 6º, re-salvaged those that may impair the scientific or technological research or development activities or the commercial activities of third parties, and may be this information made available upon authorization from the user.

Art. 13. The following activities may, at the discretion of the Union, be carried out upon prior authorization in the form of the regulation:

I-access to the genetic heritage or to the associated traditional knowledge in indispensable area to national security, which will give after annuence of the National Defence Council;

II-access to genetic heritage or to the traditional knowledge associated in waters Brazilian jurisdictions, on the continental shelf and in the exclusive economic zone, which will give after annuence of the maritime authority.

§ 1º Access and shipping authorizations may be required in conjunction or isolatedly.

§ 2º The genetic heritage sample shipment authorization for the exterior transfers the responsibility of the sample or the material remitted to the addressate.

§ 3º (VETADO).

§ 4º (VETADO).

Art. 14. The conservation ex situ of sample of the genetic heritage found in the in situ condition should preferably be carried out on the national territory.

Art. 15. The authorization or the enrollment for sample shipment of the genetic heritage to the outside depends on the information of the intended use, observed the requirements of the regulation.

Art. 16. For the economic exploitation of finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge will be required:

I-the notification of the finished product or of the reproductive material to the CGen; and

II-the presentation of the benefits apportionment agreement, re-salvaged the provisions of § 5º of the art. 17 and in § 4º of the art. 25.

§ 1º The modality of apportionment of benefits, monetary or non-monetary, should be indicated at the time of notification of the finished product or reproductive material arising from the access to genetic heritage or associated traditional knowledge.

§ 2º The benefits apportionment agreement is to be presented at up to 365 (three hundred and sixty-five) days from the time of notification of the finished product or the reproductive material, in the form provided for in Chapter V of this Act, resurrected cases involving traditional knowledge of identifiable origin are resurrected.

CHAPTER V

OF THE BENEFITS APPORTIONMENT

Art. 17. The benefits resulting from the economic exploitation of finished product or reproductive material coming from access to the genetic heritage of species found under in situ conditions or to the associated traditional knowledge, yet produced out of the Country, will be rebroken, in a fair and equitable manner, being that in the case of the finished product the component of genetic heritage or associated traditional knowledge should be one of the main elements of value aggregation, accordingly to what establishes this Law.

§ 1º Will be subject to the distribution of benefits exclusively the manufacturer of the product finished or the producer of the reproductive material, regardless of who held the access previously.

§ 2º The manufacturers of intermediate products and developers of processes coming from access to genetic heritage or associated traditional knowledge along the productive chain will be exempt from the apportionment obligation.

§ 3º When a single finished product or reproductive material is the result of distinct accesses, these will not be considered cumulatively for the calculation of the apportionment of benefits.

§ 4º The licensing, transfer or permission transactions of use of any form of intellectual property law on finished product, process or reproductive material arising from the access to the genetic heritage or to the traditional knowledge associated by third parties are characterized as free economic exploitation of the obligation to apportionment of benefits.

§ 5º Ficam exempted from the obligation to apportionment benefits, in the terms of the regulation:

I-the microenterprises, the small businesses, the individual microentrepreneurs, as laid out in the Supplementary Act No. 123, of December 14, 2006; and

II-the traditional farmers and their cooperatives, with annual gross revenue equal to or less than the upper limit set in the inciso II of the art. 3º of the Supplementary Act No. 123 of December 14, 2006.

§ 6º In the case of access to traditional knowledge associated with the persons provided for in § 5º, the holders of that knowledge will be benefited under the art. 33.

§ 7º Case the finished product or the reproductive material has not been produced in Brazil, the importer, subsidiary, controlled, collated, bound, or trade representative of the foreign producer in national territory or in territory of countries with which Brazil is to maintain agreement with this end responds in solidarity with the manufacturer of the finished product or of the reproductive material by the apportionment of benefits.

§ 8º In the absence of access to essential information to the determination of the basis of calculation of apportionment of benefits in appropriate time, in the cases referred to in § 7º, the Union shall arbitrate the value of the calculation basis according to the best available information, considering the percentage provided for in this Act or in sectoral agreement, guaranteed the contradictory.

§ 9º The Union shall establish by decree the Repartition Classification List of Benefits, based on the Common Nomenclature of Mercosur-NCM.

§ 10. (VETADO).

Art. 18. The benefits resulting from the economic exploitation of product arising from access to genetic heritage or the associated traditional knowledge for agricultural activities will be shared about the commercialization of the reproductive material, albeit the access or economic exploitation give by means of a subsidiary physical or legal person, controlled, collated, contracted, outsourced or linked, respected the provisions of § 7º of the art. 17.

§ 1º The apportionment of benefits, provided for in the caput, is to be applied to the last link of the productive chain of reproductive material, becoming exempt the remaining links.

§ 2º In the case of economic exploitation of reproductive material coming from access to genetic heritage or the associated traditional knowledge for the purposes of agricultural activities and intended solely for the generation of finished products in the productive chains that do not involve agricultural activity, the apportionment of benefits will occur only about the economic exploitation of the finished product.

§ 3º It is exempt from the distribution of benefits the economic exploitation of finished product or of reproductive material arising from access to the genetic heritage of species introduced into the national territory by human action, yet domesticated except:

I-those that form in spontaneous populations that have acquired distinctive features of their own in the Country; and

II-variety traditional local or creoula or the locally adapted breed or creole.

Art. 19. The apportionment of benefits arising from the economic exploitation of finished product or reproductive material arising from access to genetic heritage or to the associated traditional knowledge could be constituted in the following modalities:

I-monetary; or

II-non-monetary, including, among others:

a) projects for the conservation or sustainable use of biodiversity or for protection and maintenance of knowledge, innovations or practices of indigenous people, from traditional communities or from traditional farmers, preferentially at the place of occurrence of the species in in situ condition or from obtaining the sample when not being able to specify the site original;

b) transfer of technologies;

c) provision in public domain of product, without protection by intellectual property right or constraint technological;

d) licensing of free products of burden;

e) empowerment of human resources in themes related to the conservation and sustainable use of genetic heritage or of the associate traditional knowledge; and

f) free distribution of products in programs of social interest.

§ 1º In the case of access to genetic heritage lies at the discretion of the user the option by a of the arrangements for apportionment of benefits provided for in the caput.

§ 2º Act of the Executive Power shall discipline the form of distribution of benefits of modality non-monetary in the cases of access to genetic heritage.

§ 3º The allocation of non-monetary benefits corresponding to technology transfer may take place, among other forms, by:

I-participation in research and technological development;

II-exchange of information;

III-exchange of human resources, materials, or technology between national scientific research institution and technological, public or private, and research institution based abroad;

IV- consolidation of research and technological development infrastructure; and

V- establishment of joint technological base venture.

§ 4º (VETADO).

Art. 20. When the chosen modality is the allocation of monetary benefits arising from the economic exploitation of finished product or reproductive material arising from access to genetic heritage, a share of 1% (one percent) of the revenue will be due annual net obtained with the economic holding, the reduction hypothesis to up to 0.1 (one tenth) per sectoral agreement provided for in the art. 21.

Art. 21. With a view to ensuring the competitiveness of the contemplated sector, the Union may, at the request of the person concerned, as per the regulation, conclude sectoral agreement that allows to reduce the value of the allocation of monetary benefits to up to 0.1% (one tenth by one) of the annual net income obtained with the economic exploitation of the finished product or of the reproductive material arising from access to genetic heritage or to the associated traditional knowledge of non-identifiable origin.

Single paragraph. To subsidize the celebration of sectoral agreement, official rights bodies for the rights of indigenous peoples and traditional communities will be able to be heard, under the regulation.

Art. 22. In the modalities of apportionment of non-monetary benefits corresponding to points (a) and, and f of the inciso II of the art caput. 19, the allocation of benefits should be equivalent to 75% (seventy and five per cent) of the forecast for monetary modality, as per the criteria defined by the CGen.

Single paragraph. The CGen will be able to delimit criteria or parameters of result or effectiveness that users should meet, in replacement to the predicted cost parameter in the caput for the apportionment of non-cash benefits.

Art. 23. When the finished product or reproductive material comes from access to the associated traditional knowledge of unidentifiable origin, the apportionment arising from the use of that knowledge is to be done in the modality provided for in the inciso I of the caput of the art. 19 and in amount corresponding to the established in the arts. 20 and 21 of this Act.

Art. 24. When the finished product or reproductive material comes from access to the associated traditional knowledge that is of identifiable origin, the associated traditional knowledge provider will be entitled to receive benefits upon agreement of distribution of benefits.

§ 1º The apportionment between user and provider will be negotiated form fair and equitable among the parties, meeting the parameters of clarity, loyalty and transparency in the paced clauses, which should indicate conditions, obligations, types and duration of the short, medium and long term benefits.

§ 2º The apportionment with the remaining holders of the same associated traditional knowledge will give itself in the monetary modality, carried out through the National Fund for the Breakdown of Benefits-FNRB.

§ 3 ° The share due by the user for the apportionment of benefits provided for in § 2º, to be deposited in the National Fund for the Repartition of Benefits-FNRB, will correspond to the half of that provided for in the art. 20 of this Act or set out in sectoral agreement.

§ 4º The apportionment of benefits of which it treats the § 3º independed on the amount of too many holders of the associated traditional knowledge accessed.

§ 5º In any case, it is presumed, in an absolute way, the existence of too many holders of the same traditional knowledge associated.

Art. 25. The benefits apportionment agreement should indicate and qualify with clarity the parties, which will be:

I-in the case of economic exploitation of finished product or of reproductive material coming from access to genetic heritage or associated traditional knowledge of origin no identifiable:

a) the Union, represented by the Ministry of the Environment; and

b) the one that economically explores finished product or reproductive material from access to the genetic heritage or the associated traditional knowledge of non-identifiable origin; and

II-in the case of economic exploitation of finished product or of reproductive material coming from access to traditional knowledge-associated source of identifiable origin:

a) the associated traditional knowledge provider; and

b) the one that economically explores finished product or reproductive material from access to knowledge traditional associate.

§ 1º Additionally to the Benefits Partition Agreement, the user must deposit the value stipulated in § 3º of the art. 24 in the National Fund for the Repartition of Benefits-FNRB when exploring economically finished product or reproductive material coming from access to traditional associate knowledge of identifiable origin.

§ 2º In the case of economic exploitation of finished product or of reproductive material coming from access to genetic heritage or to the associated traditional knowledge of non-identifiable origin, sectoral agreements with the Union with an objective of apportionment of benefits, as per regulation, may be signed.

§ 3º The apportionment of benefits arising from the economic exploitation of finished product or of reproductive material arising from access to the associated traditional knowledge dispensing the user from redeeming benefits regarding the genetic heritage.

§ 4º The apportionment of monetary benefits of which it treats the inciso I of the caput could, at the discretion of the user, be deposited directly into the National Fund for the Repartition of Benefits-FNRB, with no need for celebration of benefit apportionment agreement in the form of the regulation. Art. 26. They are essential clauses of the benefits apportionment agreement, without prejudice to others that are to be established in regulation, those that they dispose of:

I-products object of economic exploitation;

II-term of duration;

III-modality of apportionment of benefits;

IV-rights and responsibilities of the parties;

V-right of intellectual property;

VI-rescission;

VII -penalties; and

VIII-foro in Brazil.

CHAPTER VI

OF THE ADMINISTRATIVE SANCTIONS

Art. 27. Administrative infringement is considered against the genetic patrimony or against the traditional knowledge associated with all action or omission that violates the norms of this Act in the form of the regulation.

§ 1º Without prejudice to the criminal sanctions and civil penalties, administrative infractions will be punishable by the following sanctions:

I-warning;

II-fine;

III-seizure:

a) of the samples that contain the accessed genetic heritage;

b) of the instruments used in obtaining or processing the genetic heritage or the associated traditional knowledge accessed;

c) of the products derived from access to genetic heritage or to the associated traditional knowledge; or

d) of the products obtained from information about traditional knowledge associated;

IV-temporary suspension of the manufacture and sale of the finished product or of the derivative reproductive material of access to genetic heritage or associated traditional knowledge up to regularization;

V-embargo of the specific activity related to the infraction;

VI-partial or total interdiction of the establishment, activity, or undertaking;

VII-suspension of attestate or authorization of which it treats this Act; or

VIII-cancellation of attestate or authorization of which it treats this Law.

§ 2º For the imposition and gradation of administrative sanctions, the competent authority observes:

I-the severity of the fact;

II-the antecedents of the offender, as to the compliance with the legislation regarding genetic heritage and the associate traditional knowledge;

III-the recidivism; and

IV-the economic situation of the offender, in the case of fine.

§ 3º The penalties provided for in § 1º will be able to apply cumulatively.

§ 4º The samples, the products and the instruments of which it treats the inciso III of § 1st will its targeting defined by the CGen.

§ 5º The fine of which treats the inciso II of § 1º will be arbitrated by the competent authority, per infraction, and may vary:

I-from R$ 1,000.00 (thousand actual) to R$ 100,000.00 (one hundred thousand reais), when the infraction is committed by 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 legal person, or with its contest.

§ 6º Checks of recidivism when the agent commits new infraction within up to 5 (five) years counted from the transit on trial of the administrative decision that has convicted him of prior infringement.

§ 7º The regulation will have on the administrative process of its own for application of the sanctions that it treats this Act, secured the right to ample defence and adversarial.

Art. 28. The competent federal bodies shall exercise the surveillance, interception and seizure of samples containing the accessed genetic heritage, of products or of reproductive material arising from access to genetic heritage or knowledge traditional associate, when the access or economic exploitation has been at odds with the provisions of this Act and its regulation.

Art. 29. (VETADO).

CHAPTER VII

FROM THE NATIONAL FUND FOR THE APPORTIONMENT APPORTIONMENT AND THE NATIONAL BENEFITS APPORTIONMENT PROGRAMME

Art. 30. It is established the National Fund for the Repartition of Benefits-FNRB, of a financial nature, linked to the Ministry of the Environment, with the aim of valuing the genetic heritage and associated traditional knowledge and furthering its use in a sustainable way.

Art. 31. The Executive Power will have in regulation on the composition, organization and operation of the Gestor Committee of the FNRB.

Paragraph single. The management of monetary resources deposited in the FNRB intended for indigenous populations, traditional communities and traditional farmers will give with their participation in the form of the regulation.

Art. 32. They constitute revenue from the FNRB:

I-appropriations consigned to the annual budget law and its additional credits;

II-donations;

III-values raised with the payment of administrative fines applied in virtue of the defulfillment of this Act;

IV-financial resources of external origin arising from contracts, agreements or arrangements, specially reserved for the purposes of the Fund;

V-contributions made by users of genetic heritage or associated traditional knowledge for the National Program of Repartition of Benefits;

VI-values arising from the apportionment of benefits; and

VII-other recipes that come to you to be targeted.

§ 1º The monetary resources deposited in the FNRB arising from the economic exploitation of finished product or reproductive material from access to traditional knowledge associated will be targeted exclusively for the benefit of holders of traditional associated knowledge.

§ 2º The monetary resources deposited in the FNRB arising from the economic exploitation of finished product or reproductive material arising from access to genetic heritage coming from ex situ collections will be partially intended for the benefit of these collections, in the form of the regulation.

§ 3º The FNRB will be able to establish instruments of cooperation, including with states, Municipalities and the Federal District.

Art. 33. It is established the National Benefits-PNRB Repartition Program, with the purpose of promoting:

I-conservation of biological diversity;

II-retrieval, creation and maintenance of ex situ collections of genetic heritage sample;

III-prospection and empowerment of human resources associated with the use and conservation of genetic heritage or of the associate traditional knowledge;

IV-protection, promotion of the use and valorisation of the traditional knowledge associated;

V-implantation and development of activities related to the sustainable use of biological diversity, its conservation and benefits apportionment;

VI-fosters the research and technological development associated with genetic heritage and associated traditional knowledge;

VII-surveying and inventory of genetic heritage, considering the situation and degree of variation of populations existing ones, including those of potential use and, when feasible, assessing any threat to them;

VIII-support for the efforts of Indigenous peoples, traditional communities and traditional farmers in sustainable manhandling and genetic heritage conservation;

IX-conservation of wildlife plants;

X-development of an efficient and sustainable system of conservation ex situ and in situ and development and transfer of appropriate technologies for this purpose with views to improve the sustainable use of genetic heritage;

XI-monitoring and maintenance of the feasibility, the degree of variation and genetic integrity of the genetic heritage collections;

XII-adoption of measures to minimise or, if possible, eliminate the threats to genetic heritage;

XIII-development and maintenance of the diverse cultivation systems that favour sustainable use of the genetic heritage;

XIV-elaboration and execution of the Development Plans Sustainable of Populations or Traditional Communities; and

XV-other actions related to the access to genetic heritage and associated traditional knowledge, as per the regulation.

Art. 34. The PNRB will be implemented through the FNRB.

CHAPTER VIII

OF THE TRANSITIONAL PROVISIONS ON SUITABILITY AND REGULARIZATION OF ACTIVITIES

Art. 35. The application for permission or regularization of access and shipment of genetic heritage or associated traditional knowledge still in tramway on the date of entry into force of this Act should be reformulated by the user as an application for enrollment or of access authorization or shipment, as the case may be.

Art. 36. The deadline for the user to reshape the application for authorization or regularization of which it treats art. 35 will be 1 (one) year, counted from the date of the provision of the enrollment by the CGen.

Art. 37. It should suit the terms of this Act, within 1 (one) year, counted from the date of the provision of the enrollment by the CGen, the user who carried out, as of June 30, 2000, the following activities in accordance with the Provisional Measure No. 2.186-16, of August 23, 2001:

I-access to genetic heritage or traditional knowledge associated;

II-economic exploitation of finished product or reproductive material coming from of access to genetic heritage or to the associated traditional knowledge.

Single paragraph. For the purposes of the willing on the caput, the user, observed the art. 44, should adopt one or more of the following arrangements, as the case may be:

I-cadastrate the access to genetic heritage or associated traditional knowledge;

II-notify the finished product or the reproductive material the object of the economic exploitation, pursuant to this Act; and

III-redeed the benefits pertaining to the economic exploitation carried out from the date of entry into force of this Act, pursuant to Chapter V, except when it has done so in the form of the Provisional Measure no 2.186-16, of August 23, 2001.

Art. 38. It should be regularised under this Act, within 1 (one) year, counted from the date of the provision of the Cadastro by the CGen, the user who, between June 30, 2000 and the date of entry into force of this Act, carried out the following activities in disagreement with the legislation in force at the time:

I-access to genetic heritage or the traditional knowledge associated;

II-access and economic exploitation of product or process arising from the access to genetic heritage or the associated traditional knowledge, of which it treats the Provisional Measure No. 2.186-16, of August 23, 2001;

III-shipment abroad of genetic heritage sample; or

IV-dissemination, transmission, or relay of data or information that integrates or constitutes associated traditional knowledge.

§ 1º The regularization of which treats the caput is conditioned the signature of Term of Commitment.

§ 2º In the hypothesis of access to genetic heritage or knowledge Traditional associated solely for the purpose of scientific research, the user will be relieved to firm up the Term of Appointment, regularizing through enrollment or authorization of the activity, as the case may be.

§ 3º The enrollment and the authorization of which it treats § 2º extinguishes the exigency of the sanctions administrative provisions set out in the Provisional Measure No. 2.186-16, of August 23, 2001, and specified in the arts. 15 and 20 of Decree No. 5,459 of June 7, 2005 provided that the infraction has been committed until the day before the date of entry into force of this Act.

§ 4º For purposes of regularization at the National Institute of Industrial Property-INPI of patent applications filed for the duration of the Provisional Measure No. 2.186-16, of August 23, 2001, the applicant should submit the voucher for enrollment or authorization of which he / she treats this article.

Art. 39. The Term of Appointment will be firmed up between the user and the Union, represented by the Minister of State for the Environment.

Paragraph single. The Minister of State for the Environment will be able to delegate the envisaged competence in the caput.

Art. 40. The Term of Appointment should provide for, as the case may be:

I-the enrolment or the authorization of access or remittance of genetic heritage or associated traditional knowledge;

II-a notification of product or process arising from the access to genetic heritage or associated traditional knowledge, of which it treats the Provisional Measure No. 2.186-16, of August 23, 2001; and

III-the apportionment of benefits obtained, in the form of Chapter V of this Act, concerning the time in which the product developed after June 30, 2000 coming from access to genetic heritage or the associated traditional knowledge has been made available on the market, at the limit of up to 5 (five) years prior to the conclusion of the Term of Appointment, subtracted the time of overwriting the process in tramway in the CGen.

Art. 41. The signing of the Term of Appointment will suspend, in all cases:

I-the application of the administrative penalties provided for in the Provisional Measure no 2.186-16, of August 23, 2001, and specified in the arts. 16 a 19 and 21 a 24 of Decree No. 5,459 of June 7, 2005 provided that the infraction has been committed until the day before the date of the entry into force of this Act; and

II-the exigsibility of the sanctions applied on the basis of the Interim Measment No. 2.186-16 of August 23, 2001 and in the arts. 16 a 19 and 21 a 24 of Decree No. 5,459 of June 7, 2005.

§ 1º The Term of Commitment that it deals with this article constitutes executive title extrajudicial. § 2nd Suspend is the prescription during the term of the Term of Appointment.

§ 3º Fully fulfilled the obligations assumed in the Term of Appointment, provided that proven in technical advice issued by the Ministry of the Environment:

I-will not apply the administrative sanctions of which they treat the arts. 16, 17, 18, 21, 22, 23 and 24 of Decree No. 5,459, of June 7, 2005;

II-the sanctions administrative applied on the basis of the arts. 16 a 18 of the Decree No 5,459 of June 7, 2005 will have its extinguishability extinguished; and

III -the values of the fines applied on the basis of the arts. 19, 21, 22, 23 and 24 of Decree No. 5,459, of June 7, 2005, updated monetarily, will be reduced by 90% (ninety percent) of its value.

§ 4º The user who has started the regularization process prior to the date of entry into force of this Act could, at its discretion, reap the benefits according to the terms of the Provisional Measure No. 2.186-16 of August 23, 2001.

§ 5º The remaining balance of the values of which it treats the inciso III of § 3º will be converted, the application by the user, by the supervisory authority, in obligation to carry out one of the modalities of apportionment of non-monetary benefits, provided for in the inciso II of the art caput. 19 of this Law.

§ 6º The penalties provided for in the caput will have immediate exigency in the chances of:

I-disfulfillment of the obligations provided for in the Term of Appointment on the fact of the offender; or

II-practice of new administrative infraction provided for in this Act during the term of the Term of Appointment.

§ 7º The extinction of the penalty of the fine does not mischaracterize the infraction already committed to purposes of recidivism.

Art. 42. In the interests of the parties, with the aim of fining contentious issues and possible administrative or judicial disputes, the rules of regularization or appropriateness may be applied, as per the observed hypothesis, albeit for cases previous to Provisional Measure No. 2,052 of June 29, 2000. Single paragraph. In the case of judicial dispute, complied with the rules for regularization or appropriateness provided for in this Act, the Union shall be authorized to:

I-firm agreement or court transaction; or

II-give up the action.

Art. 43. Valid acts and decisions of the CGen regarding access or remittance activities of genetic heritage or associated traditional knowledge that have generated products or processes in marketing in the market and which have already been the object of regularization before the entry into force of this Act.

§ 1º Caberá to the CGen cadastrate in the system the authorizations already issued.

§ 2º The benefits apportionment agreements concluded prior to the entry into force of this Act will be valid by the deadline in them.

Art. 44. They are remitted the civil reparations related to genetic heritage or the associated traditional knowledge of which the Union is creditor.

Art. 45. The application for regularization provided for in this Chapter authorizes the continuity of the ongoing industrial property law application analysis in the competent body.

CHAPTER IX

FINAL PROVISIONS

Art. 46. The activities carried out on genetic heritage or on associated traditional knowledge that constarvate in international agreements approved by the National Congress and promulgated, when used for the purposes of the said agreements international, should be effected in accordance with the conditions laid down in them, kept the requirements of them constant.

Single paragraph. The distribution of benefits provided for in the Nagoia Protocol does not apply to the economic exploitation, for purposes of agricultural activity, of reproductive material of species introduced in the Country by human action until the entry into force of that Treaty.

Art. 47. The granting of intellectual property law by the competent body on finished product or on reproductive material obtained from access to genetic heritage or the associated traditional knowledge becomes conditional on enrollment or authorization, under the terms of this Act. Art. 48. They become extinct, within the scope of the Executive Power, Technical Commissioned Functions, created by art. 58 of the Provisional Measure No. 2.229-43 of September 6, 2001, in the following quantitative ones by level:

I-33 (thirty-three) FCT-12; and

II-53 (fifty-three) FCT-11.

Paragraph single. The following posts are created in committee Group-Direction and Superiors Superiors-DAS, intended for the unit that will exercise the function of Executive Secretariat of the CGen:

I-1 (one) DAS-5;

II-3 (three) DAS-4; and

III-6 (six) DAS-3. Art. 49. This Law comes into effect after decorations 180 (one hundred and eighty) days of the date of its official publication.

Art. 50. It is repealed the Provisional Measure No. 2.186-16, of August 23, 2001.

Brasilia, May 20, 2015; 194º of Independence and 127º 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