0A4F4F9BD490A749D5437F821CF06DF1
Law Decree No 8.772/2016 (2016), Regulating Law No. 13.123/2015
http://www.planalto.gov.br/ccivil_03/_ato2015-2018/2016/decreto/D8772.htm
http://leaux.net/URLS/ConvertAPI Text Files/C6BF49874F49433803F5165493FE25F5.en.txt
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This file was generated: 2020-07-15 04:13:38
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Indigenous
Searching for indicator indigenous:
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p.(None): associated traditional knowledge and benefit sharing for conservation and sustainable use of biodiversity.
p.(None): § 1 The part of the genetic heritage existing in the national territory is considered, for the purposes of this Decree, the microorganism that has been isolated from
p.(None): substrates of the national territory, the territorial sea, the exclusive economic zone or the continental shelf.
p.(None): § 2 The microorganism will not be considered a national genetic heritage when the user, upon request by the competent authority, proves:
p.(None): I - that was isolated from substrates that are not from the national territory, the territorial sea, the exclusive economic zone or the continental shelf; and
p.(None): II - the regularity of its import.
p.(None): § 3 The plant and animal species introduced in the Country will only be considered genetic heritage found in conditions in situ in the national territory
p.(None): when they form spontaneous populations that have acquired their own distinctive characteristics in the country.
p.(None): § 4 The genetic heritage found in situ conditions is also considered to be the variety from a species introduced in the national territory with
p.(None): genetic diversity developed or adapted by indigenous populations, traditional communities or traditional farmers, including combined natural selection
p.(None): with human selection in the local environment, which is not substantially similar to commercial cultivars.
p.(None): Art. 2 The following activities are subject to the requirements of Law No. 13,123, 2015, and this Decree:
p.(None): I - access to genetic heritage or associated traditional knowledge;
p.(None): II - sending samples of genetic heritage abroad; and
p.(None): III - economic exploitation of finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge
p.(None): carried out after the entry into force of Law No. 13,123, of 2015.
p.(None): § 1 For the purposes of the provision in item II of the caput, the practice of any research or technological development activity that is carried out after 17
p.(None): November 2015, will be, regardless of the date of its beginning, considered as access made after the entry into force of Law No. 13,123, of 2015.
p.(None): § 2 The activities carried out between June 30, 2000 and November 17, 2015 must comply with the provisions of Chapter VIII of this Decree.
p.(None): Art. 3 The access to genetic heritage or associated traditional knowledge is not subject to the requirements of Law No. 13,123, 2015
p.(None): completed before June 30, 2000 and the economic exploitation of the finished product or reproductive material resulting therefrom.
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p.(None): VI - record 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.
p.(None): 16 of Law No. 13,123, of 2015;
p.(None): VII - promote public debates and consultations on the topics covered by Law No. 13,123, of 2015;
p.(None): VIII - to function as a higher level of appeal in relation to the decision of an accredited institution and the acts resulting from the application of Law No. 13,123, of 2015
p.(None): ;
p.(None): IX - establish guidelines for the application of the resources destined to the National Fund for the Sharing of Benefits - FNRB, by way of sharing of
p.(None): benefits;
p.(None): X - create and maintain a relative database:
p.(None): a) records of access to genetic heritage or associated traditional and referral knowledge;
p.(None): b) authorizations for access to genetic heritage or associated traditional and referral knowledge;
p.(None): c) instruments and material transfer terms for sending samples and shipments;
p.(None): d) the ex situ collections of accredited institutions that contain samples of genetic heritage;
p.(None): e) notifications of finished product or reproductive material;
p.(None): f) benefit sharing agreements; and
p.(None): g) certificates of regularity of access;
p.(None): XI - scienti fi c federal agencies to protect the rights of indigenous populations, traditional communities and traditional farmers on registration in
p.(None): registration of access to associated traditional knowledge; and
p.(None): XII - approve its internal regulations, which shall provide, at least, about:
p.(None): a) organization and functioning of its meetings;
p.(None): b) functioning of the Executive Secretariat;
p.(None): c) procedure for the appointment of its Directors;
p.(None): d) removal, impediment, suspicion and hypotheses of conflict of interests of the Directors;
p.(None): e) publicizing its technical standards and resolutions; and
p.(None): f) composition and functioning of the Thematic and Sectorial Chambers.
p.(None): Single paragraph. CGen may, at the user's request, issue an internationally recognized certificate of compliance that will serve as proof that
p.(None): activities on genetic heritage or associated traditional knowledge were carried out in accordance with Law No. 13,123 of 2015 and this Decree.
p.(None): Art. 5 Without prejudice to the System provided for in Chapter IV of this Decree, CGen shall maintain its own system for traceability of activities resulting from
p.(None): access to genetic heritage or associated traditional knowledge, including those related to economic exploitation.
p.(None): § 1 Under the terms of art. 7 of Law No. 13,123 of 2015, the system provided for in the caput will be managed by the Executive Secretariat of CGen and will have the
...
p.(None): I - Plenary;
p.(None): II - Thematic Chambers;
p.(None): III - Sectorial Chambers; and
p.(None): IV - Executive Secretariat.
p.(None): Section II
p.(None): From the Plenary
p.(None): Article 7. The CGen Plenary will be composed of twenty-one members, twelve representatives of federal public administration bodies and nine
p.(None): representatives of civil society, distributed as follows:
p.(None): I - one representative from each of the following ministries:
p.(None): a) Ministry of the Environment;
p.(None): b) Ministry of Justice;
p.(None): c) Ministry of Health;
p.(None): d) Ministry of Foreign Affairs;
p.(None): e) Ministry of Agriculture, Livestock and Supply;
p.(None): f) Ministry of Culture;
p.(None): g) Ministry of Social Development and Fight against Hunger;
p.(None): h) Ministry of Defense;
p.(None): i) Ministry of Development, Industry and Foreign Trade;
p.(None): j) Ministry of Science, Technology and Innovation; and
p.(None): k) Ministry of Agrarian Development;
p.(None): II - three representatives of entities or organizations in the business sector, being:
p.(None): a) one appointed by the National Confederation of Industry - CNI;
p.(None): b) one nominated by the National Agriculture Confederation - CNA; and
p.(None): c) one nominated alternatively and successively by CNI and CNA;
p.(None): III - three representatives of entities or organizations in the academic sector, being:
p.(None): a) one nominated by the Brazilian Society for the Progress of Science - SBPC;
p.(None): b) one nominated by the Brazilian Association of Anthropology - ABA; and
p.(None): c) one nominated by the Brazilian Academy of Sciences - ABC; and
p.(None): IV - three representatives of entities or organizations representing indigenous populations, traditional communities and traditional farmers, being:
p.(None): a) one appointed by representatives of traditional peoples and communities and their organizations of the National Council of Traditional Peoples and Communities -
p.(None): CNPCT;
p.(None): b) one appointed by representatives of family farmers and their organizations from the National Council for Sustainable Rural Development - Condraf; and
p.(None): c) one nominated by representatives of indigenous peoples and organizations that are members of the National Council for Indigenous Policy - CNPI.
p.(None): § 1 CGen will be chaired by the senior adviser to the Ministry of the Environment and, in his impediments or absences, by the respective alternate.
p.(None): § 2 The representations referred to in this article shall consist of one holder and two alternates each, who will be appointed by the holder of the management bodies
p.(None): federal government and the respective legal representatives of civil society entities or organizations.
p.(None): § 3 The members of the CGen, members and alternates, will be appointed in an act of the Minister of State for the Environment, within thirty days of receiving the
p.(None): indications.
p.(None): § 4 The CGen Plenary will meet with the presence of at least eleven directors, and its decisions will be taken by a simple majority.
p.(None): Paragraph 5. The duties of the directors will not be remunerated and their exercise is considered a relevant public service, with the responsibility of public bodies and entities
p.(None): representatives of civil society defray the travel and subsistence expenses of their respective representatives.
p.(None): § 6 The Union will be responsible for defraying the travel and subsistence expenses of the members referred to in item IV of the caput.
p.(None): Section III
p.(None): Thematic Chambers and Sectorial Chambers
p.(None): Art. 8 Thematic Chambers will be created by CGen to support the decisions of the Plenary based on technical discussions and presentation of proposals on
p.(None): specific themes or areas of knowledge related to access and benefit sharing.
p.(None): § 1 The act of creating the Thematic Chambers will provide for their attributions, duration and composition, which must observe the proportion of:
p.(None): I - fifty percent of representatives of federal public administration bodies and entities with competences related to the subject of the respective Chamber;
p.(None): II - twenty-five percent of organizations representing the user sector; and
p.(None): III - twenty-five percent of organizations representing associated traditional knowledge providers.
p.(None): § 2 The CGen may create a special Thematic Chamber to analyze and support the Plenary's judgment of appeals filed as a last resort.
p.(None): Art. 9 The Sectorial Chambers will be created by CGen to support the decisions of the Plenary based on technical discussions and presentation of proposals for
p.(None): interest of the business and academic sectors, as well as of indigenous populations, traditional communities and traditional farmers.
p.(None): Single paragraph. The act of creation of the Sectorial Chambers will provide for their attributions, duration and composition, which must observe parity between
p.(None): representation of federal public administration bodies and entities with competences related to the respective Chamber and the civil society sector
p.(None): corresponding.
p.(None): Art. 10. The members of the Thematic Chambers and the Sectorial Chambers will be appointed by the members of the Plenary of CGen, considering the formation, the
p.(None): performance or notorious knowledge in the area related to the Chamber's competences.
p.(None): Section IV
p.(None): The Executive Secretariat
p.(None): Art. 11. The Executive Secretariat of CGen is responsible for:
p.(None): I - provide technical and administrative support to the Plenary of CGen and its Chambers;
p.(None): II - promote the instruction and processing of the processes to be submitted to CGen's decision;
p.(None): III - issue, in accordance with the resolution of CGen, the acts and decisions within its competence;
p.(None): IV - promote, in accordance with CGen's resolution, the accreditation or disqualification of:
p.(None): a) a national institution that maintains an ex situ collection of samples containing the genetic heritage; and
p.(None): b) national public institution to be responsible for the creation and maintenance of a database dealing with the item listed in items of item IX of § 1
p.(None): of art. 6 of Law No. 13,123, of 2015; and
p.(None): V - implement, maintain and operate the systems:
p.(None): a) traceability of information related to genetic heritage and associated traditional knowledge, provided for in art. 5th; and
p.(None): b) covered by Chapter IV of this Decree.
p.(None): CHAPTER III
p.(None): OF ASSOCIATED TRADITIONAL KNOWLEDGE
p.(None): Art. 12. The right to participation of indigenous populations, traditional communities and traditional farmers who create, develop, own or
p.(None): retain traditional associated knowledge in the decision-making process on issues related to access to associated traditional knowledge and
p.(None): benefit sharing resulting from that access.
p.(None): § 1 Access to associated traditional knowledge of identifiable origin is subject to obtaining prior informed consent.
p.(None): § 2 Access to associated traditional knowledge of non-identifiable origin does not depend on prior informed consent.
p.(None): § 3 Any indigenous population, traditional community or traditional farmer who creates, develops, holds or retains certain knowledge
p.(None): associated traditional is considered an identifiable source of this knowledge, except in the hypothesis of § 3 of art. 9 of Law No. 13,123, of 2015.
p.(None): Art. 13. The indigenous population, traditional community or traditional farmer may deny consent to access their associated traditional knowledge
p.(None): of identifiable origin.
p.(None): Art. 14. The provider of associated traditional knowledge of identifiable origin will choose the form of proof of his prior informed consent,
p.(None): it will freely negotiate its terms and conditions, as well as those of the benefit sharing agreement, including the modality, guaranteeing the right to refuse them.
p.(None): § 1 The parties may establish a deadline for the registration of access to associated traditional knowledge, which is the object of consent, which does not
p.(None): may exceed the time limit set out in § 2 of art. 12 of Law No. 13,123, of 2015.
p.(None): § 2 The federal bodies and entities for the protection of rights, assistance or promotion of the activities of indigenous populations, traditional communities and
p.(None): Traditional farmers should, at the request of the holders, advise on the activities of obtaining prior informed consent and the negotiation of
p.(None): benefit sharing.
p.(None): § 3 For the purposes of the provisions of § 2, federal bodies and entities may request technical support from CGen's Executive Secretariat.
p.(None): Art. 15. Obtaining prior informed consent from an associated traditional knowledge provider must respect traditional forms of organization
p.(None): and representation of the indigenous population, traditional community or traditional farmer and the respective community protocol, if any.
p.(None): Art. 16. The user must observe the following guidelines for obtaining prior informed consent:
p.(None): I - clarifications to the indigenous population, traditional community or traditional farmer about:
p.(None): a) the social, cultural and environmental impacts resulting from the execution of the activity involving access to associated traditional knowledge;
p.(None): b) the rights and responsibilities of each party in carrying out the activity and its results; and
p.(None): c) the right of the indigenous population, traditional community and traditional farmer to refuse access to associated traditional knowledge;
p.(None): II - establishment, together with the indigenous population, traditional community or traditional farmer, of the benefits sharing modalities,
p.(None): monetary or non-monetary, derived from economic exploitation; and
p.(None): III - respect for the right of the indigenous population, traditional community and traditional farmer to refuse access to associated traditional knowledge, during
p.(None): the prior consent process.
p.(None): Art. 17. Subject to the guidelines referred to in art. 16, the instrument of proof of obtaining prior informed consent will be formalized in
p.(None): language accessible to the indigenous population, the traditional community and the traditional farmer and will contain:
p.(None): I - description of the history of the process for obtaining prior informed consent;
p.(None): II - the description of the traditional forms of organization and representation of the indigenous population, traditional community or traditional farmer;
p.(None): III - the objective of the research, as well as its methodology, duration, budget, possible benefits and sources of financing for the project;
p.(None): IV - the intended use of the associated traditional knowledge to be accessed; and
p.(None): V - the geographical area covered by the project and the indigenous populations, traditional communities or traditional farmers involved.
p.(None): Single paragraph. The instrument referred to in the caput must also expressly mention whether the indigenous population, the traditional community or the farmer
p.(None): traditional group received technical or legal advice during the process of obtaining prior informed consent.
p.(None): Art. 18. Access to the genetic heritage of the local or Creole traditional variety or to the locally adapted or Creole breed for agricultural activities comprises
p.(None): access to associated traditional knowledge of non-identifiable origin that gave rise to the variety or race and does not depend on prior consent from the
p.(None): indigenous population, traditional community or traditional farmer who creates, develops, owns or preserves the variety or breed.
p.(None): § 1 Under the terms of item XXIV of art. 2 of Law No. 13,123, of 2015, the activities of production, processing and
p.(None): commercialization of food, beverages, fibers, energy and planted forests.
p.(None): § 2 The biofuels, such as ethanol, biodiesel, biogas and cogeneration of electric energy from
p.(None): biomass processing.
p.(None): § 3 For activities that do not fit the concept of agricultural activity, access to the genetic heritage of a traditional local or Creole variety or to
p.(None): locally adapted or creole breed comprises the associated traditional knowledge that gave rise to the variety or breed, and will follow the rules of access to
p.(None): associated traditional knowledge set out in Law No. 13,123 of 2015 and in this Decree.
p.(None): § 4 In the case of access to the genetic heritage of a traditional local or creole variety referred to in the caput, the user must deposit reproductive material
p.(None): of the variety subject to access in an ex situ collection maintained by a public institution, except when the variety was obtained from the collection itself.
p.(None): Art. 19. Indigenous populations, traditional communities and traditional farmers who create, develop, hold or retain knowledge
p.(None): associated traditional rights are guaranteed to use or freely sell products containing genetic heritage or associated traditional knowledge,
p.(None): subject to the provisions of Law No. 9,456, of April 25, 1997, and Law No. 10,711, of August 5, 2003.
p.(None): Paragraph 1. Anvisa, within the scope of the powers referred to in Law No. 9,782, of January 26, 1999, will regulate the production and sale of products to
p.(None): referred to in the caput.
p.(None): § 2 The regulation provided for in § 1 must establish simplified procedures and will include the participation of indigenous populations, communities
p.(None): traditional farmers and traditional farmers, considering their uses, customs, and traditions.
p.(None): CHAPTER IV
p.(None): NATIONAL GENETIC HERITAGE AND KNOWLEDGE MANAGEMENT SYSTEM
p.(None): TRADITIONAL ASSOCIATE - SISGEN
p.(None): Section I
p.(None): General provisions
p.(None): Art. 20. The National System for the Management of Genetic Heritage and Associated Traditional Knowledge - SisGen is created, an electronic system to be implemented,
p.(None): maintained and operated by the CGen Executive Secretariat for management:
p.(None): I - the register of access to genetic heritage or associated traditional knowledge, as well as the register for sending a sample containing
p.(None): genetic heritage to provide services abroad;
p.(None): II - the record of sending a sample of genetic heritage and the Material Transfer Term;
p.(None): III - authorizations for access to genetic heritage or associated traditional knowledge and remittance abroad, in the cases referred to in art. 13
p.(None): of Law No. 13,123, of 2015;
p.(None): IV - the accreditation of the institutions that maintain the ex situ collections that contain samples of genetic heritage;
p.(None): V - notifications of finished product or reproductive material and benefit sharing agreements; and
p.(None): VI - certificates of regularity of access.
...
p.(None): Section II
p.(None): The register of access to genetic heritage or associated traditional knowledge and the register
p.(None): sending a sample containing genetic heritage to provide services abroad
p.(None): Art. 22. For the registration of access to genetic heritage or associated traditional knowledge, the natural or legal person must
p.(None): complete the electronic SisGen form which will require:
p.(None): I - user identification;
p.(None): II - information on research or technological development activities, including:
p.(None): a) summary of the activity and its respective objectives;
p.(None): b) application sector, in the case of technological development;
p.(None): c) expected or obtained results, depending on the moment of registration;
p.(None): d) responsible team, including partner institutions, if any;
p.(None): e) period of activities;
p.(None): f) identification of genetic heritage at the strictest possible taxonomic level or associated traditional knowledge, as the case may be, in particular:
p.(None): 1. the origin of the genetic heritage, including georeferenced coordinate in the degree, minute and second format, of the place of obtaining in situ, even if
p.(None): have been obtained from ex situ or in silico sources; and
p.(None): 2. of the indigenous population, traditional community or traditional farmer who provide the associated traditional knowledge, even if the knowledge
p.(None): have been obtained from secondary sources;
p.(None): g) declaration if the genetic heritage is a traditional local or creole variety or a locally adapted or creole breed, or if the species is on an official list of
p.(None): endangered species;
p.(None): h) information from the institution based abroad associated with the national institution, in the case provided for in item II of art. 12 of Law No. 13,123, of 2015; and
p.(None): i) identification of partner national institutions, if any;
p.(None): III - previous registration or authorization number, in the case of genetic heritage or associated traditional knowledge accessed from research or
p.(None): technological development carried out after June 30, 2000;
p.(None): IV - proof of obtaining prior informed consent pursuant to art. 9 of Law No. 13,123, of 2015, and of art. 17 of this Decree, when applicable;
p.(None): V - request for recognition of legal secrecy hypothesis; and
p.(None): VI - declaration, as the case may be, of classification in the event of legal exemption or non-incidence of benefit sharing.
p.(None): Paragraph 1 When it is not possible to identify the georeferenced coordinate of the on-site location referred to in item 1 of item “f” of item II of the caput, and
p.(None): only in cases in which the genetic heritage was obtained on a date prior to the entry into force of Law No. 13,123, of 2015, the provenance may be
p.(None): informed based on the most specific geographical location possible, in one of the following ways:
...
p.(None): § 1 In accordance with the provisions of § 2 of art. 32 of Law No. 13,123, of 2015, only the national institution that maintains
p.(None): ex situ collections that are accredited under this Section.
p.(None): § 2 Private non-profit institutions that maintain popular herbaria or community seed banks may be accredited as
p.(None): national institutions that maintain ex situ collections as long as they observe the provisions of this Section.
p.(None): § 3 The criteria for receiving the resources referred to in this article will be defined by the FNRB Management Committee.
p.(None): Art. 31. For the accreditation of a national institution that maintains an ex situ collection of samples containing genetic heritage, the legal entity must
p.(None): fill out an electronic form at SisGen, which will require:
p.(None): I - identification of the institution; and
p.(None): II - information on each of the ex situ collections including:
p.(None): a) identification of curators or guardians;
p.(None): b) types of preserved samples;
p.(None): c) collected taxonomic groups; and
p.(None): d) method of storage and conservation.
p.(None): § 1 Completed the completion of the form by the legal entity, CGen, under the terms of art. 6, § 1, item III, item “b”, of Law No. 13,123, of
p.(None): 2015, will decide on the accreditation referred to in the caput.
p.(None): § 2 The national institution must keep updated the information dealt with in items I and II of the caput.
p.(None): Art. 32. Samples of genetic heritage maintained in ex situ collections in national institutions managed with public resources and the information to them
p.(None): associated areas can be accessed by indigenous peoples, traditional communities and traditional farmers.
p.(None): § 1 The institution that receives the request must, within a period not exceeding twenty days:
p.(None): I - communicate the date, place and method of making the genetic heritage available;
p.(None): II - indicate the reasons for the impossibility, totally or partially, of fulfilling the request; or
p.(None): III - communicate that he does not have the genetic heritage.
p.(None): § 2 The term referred to in § 1 may be extended for another ten days, upon express justification, of which the applicant will be informed.
p.(None): § 3 The amount necessary to reimburse costs for the regeneration or multiplication of samples or availability may be charged exclusively
p.(None): information on genetic heritage.
p.(None): § 4 The provision of a sample must be free of charge when made by national institutions that maintain an ex situ collection that receive funds from the
p.(None): FNRB.
p.(None): Section VI
p.(None): Notifications of finished product or reproductive material and benefit-sharing agreements
p.(None): Art. 33. The user must notify the finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge
p.(None): carried out after the validity of Law No. 13,123, of 2015.
p.(None): § 1 The notification referred to in the caput must be made before the beginning of the economic exploration.
p.(None): § 2 For the purposes of paragraph 1, economic exploration is considered to have started when the first fiscal note for the sale of the finished product is issued or
p.(None): reproductive material.
...
p.(None): effects:
p.(None): I - allows the economic exploitation of the finished product or reproductive material, subject to the provisions of art. 16 of Law No. 13,123, of 2015; and
p.(None): II - establishes the start of the verification procedure provided for in Section VII of this Chapter.
p.(None): § 2 The user will not need to wait for the verification procedure referred to in item II of § 1 to finish before starting the economic exploration.
p.(None): Section VII
p.(None): The administrative verification procedure
p.(None): Art. 36. The administrative verification procedure provided for in this Section will be applied in cases of:
p.(None): I - registration of access to genetic heritage or associated traditional knowledge referred to in Section II of this Chapter;
p.(None): II - registration of the shipment of a sample of genetic heritage, referred to in Section III of this Chapter; and
p.(None): III - notification of finished product or reproductive material referred to in Section VI of this Chapter.
p.(None): Art. 37. During the verification period, the CGen Executive Secretariat:
p.(None): I - inform CGen's councilors about the registration or notification;
p.(None): II - forward to the members of the competent sectorial chambers the information related to the species subject to access and the Municipality of its location, according to
p.(None): dissociated form from the respective registers and other information contained therein;
p.(None): III - scientific, under the terms of item X of art. 6 of Law No. 13,123, 2015, federal bodies for the protection of the rights of indigenous populations and communities
p.(None): about registration in the registry for access to associated traditional knowledge; and
p.(None): IV - it will be able to identify, by letter, any irregularities in the registration or notification process, when it will request the ratification of the information
p.(None): or rectify formal errors.
p.(None): § 1 The provisions of the caput must be made by the Executive Secretariat of CGen within the term:
p.(None): I - fifteen days, in relation to items I, II and III; and
p.(None): II - sixty days, in relation to item IV.
p.(None): § 2 CGen's directors will have access to all available information, including those considered confidential, and will not be able to disclose it, under penalty of
p.(None): accountability, under the terms of the legislation.
p.(None): § 3 In cases of manifest fraud, the President of the CGen may cautiously suspend the registrations and the ad referendum notification of the Plenary.
p.(None): § 4 In the event of § 3, the cautionary decision will be forwarded for deliberation at the next plenary session.
p.(None): Art. 38. CGen's directors may identify signs of irregularity in the information contained in the records and the notification within sixty
p.(None): days from the date of the acknowledgment referred to in item I of the caput of art. 37.
p.(None): § 1 The board members may, within the term referred to in the caput, receive subsidies:
p.(None): I - the sectoral chambers;
p.(None): II - the bodies referred to in item III of the caput of art. 37;
p.(None): III - CGen's Executive Secretariat; and
p.(None): IV - directly from holders of associated traditional knowledge or their representatives.
...
p.(None): § 1 The requested data and information must be presented in a format compatible with the systems used by the Ministry of the Environment or in
p.(None): defined by him.
p.(None): § 2 It is the duty of the notified to provide all requested data and information, being responsible for the veracity of its content or for its omission.
p.(None): § 3 The Ministry of Finance will provide the information and technical support necessary to comply with the provisions of the caput.
p.(None): § 4 For the purposes of § 3, the Ministry of Finance will observe the provisions of § 2 of art. 198 of Law No. 5,172, of October 25, 1966 - National Tax Code.
p.(None): Art. 47. The sharing of benefits may consist of monetary and non-monetary modalities.
p.(None): § 1 In the case of economic exploitation of the finished product or reproductive material arising from access to the genetic heritage, the user shall choose
p.(None): one of the modalities of benefit sharing provided for in the caput.
p.(None): § 2 When it comes to the economic exploitation of the finished product or reproductive material arising from access to the traditional knowledge associated with
p.(None): unidentifiable origin, the allocation will be made in monetary form and will be paid to the FNRB.
p.(None): § 3 In the event of economic exploitation of finished product or reproductive material arising from access to associated traditional knowledge of origin
p.(None): identifiable, benefit sharing:
p.(None): I - must be freely negotiated between the user and the indigenous population, the traditional community or the traditional farmer who provides knowledge; and
p.(None): II - the portion owed by the user to the FNRB will correspond to 0.5% (five tenths of percent) of the annual net revenue obtained from the economic exploration or from
p.(None): half of that provided for in a sectoral agreement.
p.(None): Section II
p.(None): Monetary Benefit Sharing
p.(None): Art. 48. The monetary benefit sharing will be destined:
p.(None): I - to indigenous populations, traditional communities and traditional farmers in cases of associated traditional knowledge of identifiable origin,
p.(None): according to an agreement negotiated in a fair and equitable manner between the parties, pursuant to art. 24 of Law No. 13,123, of 2015; and
p.(None): II - to the FNRB, in the case of economic exploitation of the finished product or reproductive material arising from access:
p.(None): a) genetic heritage, in the amount of one percent of the net revenue from the finished product or reproductive material, except in the event of an agreement
p.(None): sector referred to in art. 21 of Law No. 13,123, of 2015;
p.(None): b) associated traditional knowledge of non-identifiable origin, amounting to one percent of the net revenue from the finished product or reproductive material,
p.(None): except in the event of entering into a sectoral agreement referred to in art. 21 of Law No. 13,123, of 2015; and
p.(None): c) associated traditional knowledge of identifiable origin regarding the portion referred to in § 3 of art. 24 of Law No. 13,123, of 2015.
p.(None): Art. 49. The monetary benefit sharing intended for the FNRB will be collected regardless of the benefit sharing agreement and will be calculated after
p.(None): the end of each fiscal year, considering:
p.(None): I - information on the notification of finished product or reproductive material;
p.(None): II - annual net revenue obtained from the economic exploitation of finished product or reproductive material; and
p.(None): III - current sectoral agreement applicable to the finished product or reproductive material.
p.(None): § 1 The amount referring to the sharing of benefits will be collected within 30 days after the information referred to in § 2 of art. 45 as long as there is
p.(None): economical exploitation of the finished product or reproductive material
p.(None): § 2 The first payment of the amount referring to the sharing of benefits must include the benefits earned from the beginning of the economic exploitation until the
p.(None): end of the fiscal year in which there are:
p.(None): I - presentation of the benefit sharing agreement; or
p.(None): II - notification of finished product or reproductive material in cases where the benefit sharing is deposited directly with the FNRB, including exercises
p.(None): previous, if any.
p.(None): Paragraph 3. In the event of a sectoral agreement being concluded, the benefit sharing amount due as of the year of its entry into force will be calculated for the entire period.
p.(None): fiscal year, based on the defined rate.
p.(None): § 4 For the purposes of the provisions of § 8 of art. 17 of Law No. 13,123, of 2015, with no access to information on the product manufacturer's net revenue
p.(None): finished product or reproductive material produced outside of Brazil, the basis for calculating the benefit sharing will be the net revenue of the importer, subsidiary, subsidiary,
p.(None): affiliated, linked or commercial representative of the foreign producer in national territory or abroad.
p.(None): Section III
p.(None): Non-monetary Benefit Sharing
p.(None): Art. 50. The sharing of non-monetary benefits will be made through an agreement signed:
p.(None): I - with indigenous peoples, traditional communities and traditional farmers, providers of associated traditional knowledge of origin
p.(None): identifiable, in cases of economic exploitation of the finished product or reproductive material arising from this knowledge, negotiated in a fair and equitable manner
p.(None): between the parties, under the terms of art. 24 of Law No. 13,123, of 2015; or
p.(None): II - with the Union, in the case of economic exploitation of the finished product or reproductive material arising from access to genetic heritage.
p.(None): § 1 In the benefit sharing agreements implemented through the instruments referred to in items “a”, “e” and “f” of item II of art. 19, of Law nº
p.(None): 13,123, from 2015, the breakdown will be equivalent to seventy-five percent of the forecast for the monetary modality.
p.(None): § 2 In the benefit sharing agreements implemented by means of instruments not provided for in § 1, the allocation will be equivalent to the amount provided for
p.(None): the monetary modality.
p.(None): § 3 The project management expenses, including planning, and accountability, cannot be counted to achieve the percentage provided for in §§
p.(None): 1st and 2nd.
p.(None): § 4 For the purpose of proving the equivalence referred to in §§ 1 and 2, the user must present an estimate, based on market values.
p.(None): § 5 The benefit sharing agreements entered into by the Union will be implemented, preferably, through the instrument referred to in item “a”
p.(None): of item II of art. 19, of Law No. 13,123, of 2015.
p.(None): § 6 The user may not use non-monetary benefit sharing resources in marketing campaigns or any other form of advertising in
p.(None): benefit of your products, product lines or brands.
p.(None): Art. 51. In the case of item II of art. 50, the non-monetary benefit sharing referred to in items “a” and “e” of item II of art. 19 of Law No. 13,123, of
p.(None): 2015, will be aimed at:
p.(None): I - conservation units;
p.(None): II - indigenous lands;
p.(None): III - remaining quilombo territories;
p.(None): IV - rural settlement of family farmers;
p.(None): V - traditional territories under the terms of Decree No. 6,040, of February 7, 2007;
p.(None): VI - national public research and development institutions;
p.(None): VII - priority areas for conservation, sustainable use and benefit sharing of Brazilian biodiversity, as per the act of the Minister of State of
p.(None): Environment;
p.(None): VIII - activities related to the safeguarding of associated traditional knowledge;
p.(None): IX - ex situ collections maintained by accredited institutions under the terms of Chapter IV, Section V; and
p.(None): X - indigenous populations, traditional communities and traditional farmers.
p.(None): Art. 52. In the case of item II of art. 50 the sharing of non-monetary benefits referred to in points “b”, “c”, “d” and “f” of item II of art. 19 of Law nº
p.(None): 13,123, from 2015, will be destined to national public bodies and institutions that execute social interest programs.
p.(None): Art. 53. The Ministry of the Environment may create and maintain the bank of proposals for the sharing of non-monetary benefits, which will be widely publicized,
p.(None): including through its website, to comply with the provisions of item II of art. 19 of Law No. 13,123 of 2015.
p.(None): Single paragraph. The proposals referred to in the caput should be aimed at the conservation and sustainable use of biodiversity, valuing and protecting the
p.(None): associated traditional knowledge, serving the public interest.
p.(None): Section IV
p.(None): Exemptions from benefit sharing
p.(None): Art. 54. Economic exploitation of:
p.(None): I - finished product or reproductive material developed by traditional farmers and their cooperatives, with annual gross revenue equal to or less than the limit
p.(None): maximum established in item II of art. 3 of Complementary Law No. 123, of December 14, 2006;
p.(None): II - finished product or reproductive material developed by micro-enterprises, small businesses and individual micro-entrepreneurs,
p.(None): as provided in Complementary Law No. 123, of 2006;
p.(None): III - operations for licensing, transferring or allowing the use of any form of intellectual property right over the finished product,
p.(None): reproductive process or material arising from access to genetic heritage or traditional knowledge associated by third parties;
p.(None): IV - intermediate products along the production chain;
p.(None): V - reproductive material along the productive chain of reproductive material, except for the economic exploitation carried out by the last link in the productive chain;
p.(None): VI - reproductive material arising from access to genetic heritage or associated traditional knowledge for the purposes of agricultural activities and intended
p.(None): exclusively to the generation of finished products; and
p.(None): VII - finished product or reproductive material arising from access to the genetic heritage of species introduced into the national territory by human action, still
p.(None): domesticated, except for the provisions of items I and II of § 3 of art. 18 of Law No. 13,123, of 2015.
p.(None): § 1 The exchange and dissemination of genetic heritage and associated traditional knowledge are also exempt from the obligation to share benefits.
p.(None): practiced among indigenous peoples, traditional communities or traditional farmers for their own benefit and based on their uses, customs and
p.(None): traditions;
p.(None): § 2 The exemption from the benefit sharing referred to in the caput does not relieve the user from the obligation to notify the finished product or reproductive material as
p.(None): also the fulfillment of the other obligations of Law No. 13,123, of 2015.
p.(None): § 3 The provision in § 2 does not apply to the cases provided for in § 4 of art. 8 of Law No. 13,123, of 2015.
p.(None): § 4 The user who fails to fulfill the exemption requirements provided for in Law No. 13,123, 2015, will share benefits in the following fiscal year.
p.(None): § 5 In the cases provided for in items IV, V and VI of the caput, the user must declare that the product or reproductive material fits as a product
p.(None): intermediate and will only be used for activities and processes along the reproductive chain.
p.(None): Section V
p.(None): The benefit-sharing agreement
p.(None): Art. 55. The benefit sharing agreement between user and provider will be negotiated in a fair and equitable manner between the parties, taking into account
p.(None): clarity, loyalty and transparency in the agreed clauses, which should indicate conditions, obligations, types and duration of short, medium and long term benefits,
p.(None): without prejudice to other guidelines and criteria to be established by CGen.
p.(None): Section VI
p.(None): Sectoral agreements
p.(None): Art. 56. The purpose of sectoral agreements is to guarantee the competitiveness of the productive sector in cases where the application of the 1% (one percent) portion of the
...
p.(None): e) productivity; and
p.(None): f) the degree of utilization of installed capacity;
p.(None): II - actual or potential negative effects on:
p.(None): a) stocks;
p.(None): b) employment;
p.(None): c) wages; and
p.(None): d) growth of the productive sector;
p.(None): III - the contraction in demand or changes in consumption patterns;
p.(None): IV - competition between domestic and foreign producers; and
p.(None): V - export performance.
p.(None): § 2 For the purposes of the provisions of this article, the effects of the payment of the monetary benefit sharing corresponding to the 1% portion must be segregated.
p.(None): (one percent) of the annual net revenue from the effects arising from other causes that may have caused material damage or its threat.
p.(None): § 3 For the examination of the impact referred to in the caput, it will be considered whether the value of the benefit sharing had the effect of significantly depressing the
p.(None): sales.
p.(None): Art. 61. The Ministry of Development, Industry and Foreign Trade will make the analysis referred to in art. 60 and forward a technical opinion on the request for
p.(None): reduction of the benefit sharing amount to the Ministry of the Environment, within the period referred to in § 2 of art. 59.
p.(None): Art. 62. Received the opinion referred to in art. 61, the Ministry of the Environment will issue a technical opinion that should consider the content of the manifestations:
p.(None): I - the Ministry of Development, Industry and Foreign Trade; and
p.(None): II - the official bodies for the defense of the rights of indigenous peoples, traditional communities or traditional farmers, when presented.
p.(None): Paragraph 1 Interested companies will be notified to, within thirty days, comment on the opinion referred to in the caput.
p.(None): § 2 The Ministry of the Environment may accept the statements of interested companies, at which time it will issue a new opinion.
p.(None): Art. 63. The opinion will be submitted to the Minister of State for the Environment, who will decide, on a motivated basis, on the realization or not of the sectoral agreement.
p.(None): Art. 64. The terms of the sectoral agreement in force apply to all products produced in the national territory that fall under the terms of the decision, even
p.(None): produced by companies that have not subscribed to the reduction request.
p.(None): Art. 65. The sectoral agreement will be in force for sixty months from the publication of the decision referred to in art. 63.
p.(None): § 1 In the event of a sectoral agreement in force at the time of payment of the benefit sharing referring to a given finished product or
p.(None): reproductive material, the rate to be paid will be that defined in the sectoral agreement.
p.(None): § 2 After the term referred to in the caput has elapsed, and if there is no request for extension, the sectoral agreement will be terminated.
p.(None): § 3 The sectoral agreement may be extended if the conditions that gave rise to its conclusion are maintained.
p.(None): § 4 The request for extension must be made by the interested party, at least, four months before its end.
p.(None): § 5 During the analysis of the request for extension, the sectoral agreement will remain in force.
...
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 15,000.00 (fifteen thousand reais) and maximum fine of R $ 5,000,000.00 (five million reais), for other legal entities.
p.(None): Single paragraph. The fine sanction may be substituted for the warning, when the circumstances provided for in art. 72.
p.(None): Section IV
p.(None): Administrative procedure for investigating violations
p.(None): Art. 92. Infractions against genetic heritage or associated traditional knowledge will be investigated in a specific administrative process through the
p.(None): drawing up of notice of infraction and respective terms, ensuring the right to ample defense and the adversary.
p.(None): Single paragraph. The administrative process referred to in the caput will be governed by the provisions of Decree No. 6,514, of 2008, except when
p.(None): different provision provided for in this Chapter.
p.(None): Article 93. The following are competent to inspect and investigate the administrative infractions provided for in this Decree:
p.(None): I - Ibama;
p.(None): II - the Navy Command, within the scope of Brazilian jurisdictional waters and the continental shelf; and
p.(None): III - the Ministry of Agriculture, Livestock and Supply, within the scope of access to genetic heritage for agricultural activities, under the terms of art.
p.(None): 3 of Law No. 10,883, of June 16, 2004.
p.(None): § 1 When the offense involves associated traditional knowledge, the official bodies that defend the rights of indigenous peoples, communities
p.(None): traditional farmers and traditional farmers will provide support to Ibama's inspection activities.
p.(None): § 2 Joint act of the Ministers of State for the Environment, Agriculture, Livestock and Supply and Defense will regulate the coordinated action of the
p.(None): supervisory bodies.
p.(None): Art. 94. Of the final decision issued by the bodies provided for in art. 93 CGen may appeal within twenty days.
p.(None): Art. 95. CGen act will establish criteria for the destination of the seized samples, products and instruments, referred to in § 4 of art. 27 of Law nº
p.(None): 13,123, 2015.
p.(None): Single paragraph. As long as the act referred to in the caput has not been edited, the competent authority for inspection shall make the destination, observing the provisions
p.(None): in Decree No. 6,514, of 2008.
p.(None): CHAPTER VII
p.(None): THE NATIONAL BENEFIT SHARING FUND AND THE NATIONAL BENEFIT SHARING PROGRAM
p.(None): Art. 96. The National Benefit Sharing Fund - FNRB, established by Law No. 13,123, of 2015, linked to the Ministry of the Environment, is of a nature
p.(None): financial and is intended to support actions and activities aimed at enhancing the genetic heritage and associated traditional knowledge and promoting their use of
p.(None): sustainable way.
p.(None): § 1 The FNRB's revenue comprises:
p.(None): I - appropriations enshrined in the annual budget law and their additional credits;
p.(None): II - donations;
p.(None): III - amounts collected with the payment of administrative fines imposed due to non-compliance with Law No. 13,123, of 2015;
p.(None): IV - external financial resources arising from contracts, agreements or covenants, especially reserved for the Fund's purposes;
p.(None): V - contributions made by users of genetic heritage or associated traditional knowledge to the National Benefit Sharing Program;
p.(None): VI - amounts arising from the sharing of benefits; and
p.(None): VII - other revenues that may be allocated to it.
p.(None): § 2 The monetary resources deposited in the FNRB resulting from the economic exploitation of finished product or reproductive material arising from access to
p.(None): associated traditional knowledge will be used exclusively for actions, activities and projects for the benefit of holders of traditional knowledge
p.(None): associated companies.
p.(None): § 3º The revenues destined to the FNRB and eventual returns of funds will be collected directly to the Fund, according to procedures defined by the Committee
p.(None): Manager.
p.(None): Article 97. The FNRB will be managed by a Management Committee, a collegiate body composed of:
p.(None): I - by a representative and two alternates:
p.(None): a) the Ministry of the Environment, which will preside over it;
p.(None): b) the Ministry of Finance;
p.(None): c) the Ministry of Agriculture, Livestock and Supply;
p.(None): d) from the Ministry of Social Development and Fight against Hunger;
p.(None): e) from the Ministry of Agrarian Development;
p.(None): f) the Ministry of Science, Technology and Innovation;
p.(None): g) the National Indian Foundation - Funai; and
p.(None): h) the Institute of National Historical and Artistic Heritage - Iphan;
p.(None): II - by seven representatives of entities or organizations representing indigenous populations, traditional communities and traditional farmers, being:
p.(None): a) two nominated by the National Council of Traditional Peoples and Communities - CNPCT;
p.(None): b) two nominated by the National Council for Sustainable Rural Development - Condraf;
p.(None): c) two nominated by representatives of indigenous peoples and organizations that are members of the National Council for Indigenous Policy - CNPI; and
p.(None): d) a representative of the indigenous population, traditional community or traditional farmer appointed by the National Council for Food Security and
p.(None): Nutritional - Consea; and
p.(None): III - by a representative of the Brazilian Society for the Progress of Science - SBPC.
p.(None): § 1 The representatives and their alternates will be appointed by the Minister of the Environment, after indication of the respective bodies and entities.
p.(None): § 2 The representatives and alternates will have a two-year term, renewable for an equal period.
p.(None): § 3 In the event of impediments or absences from its president, the Management Committee will be chaired by the alternate representative of the Ministry of the Environment.
p.(None): § 4 The participation in the FNRB Management Committee is considered to be of relevant public interest and will not be remunerated.
p.(None): § 5 To comply with the provisions of item IV of art. 10 of Law No. 13,123, of 2015, the travel and subsistence expenses of the representatives referred to in item II
p.(None): caput will be paid by FNBR.
p.(None): § 6 The Ministry of the Environment may bear the expenses referred to in § 5 in the first two years of operation of the FNBR.
p.(None): § 7 The Management Committee may invite other representatives, without the right to vote, to participate in its meetings.
p.(None): Art. 98. The Management Committee is responsible for:
p.(None): I - decide on the management of the monetary resources deposited in the FNRB, observing the guidelines for the application of the resources established by CGen;
p.(None): II - to define, annually, the percentage of the monetary resources deposited in the FNRB resulting from the economic exploitation of finished product or material
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p.(None): operationalization of the Fund.
p.(None): Paragraph 1 The depositary fi nancial institution will remunerate the Fund's availabilities, at least, at the average reference rate of the Special Settlement System and of
p.(None): Custody - Selic.
p.(None): § 2 The financial institution's obligations and responsibilities, as well as its remuneration, will be defined in the contract.
p.(None): Art. 100. The National Benefit Sharing Program - PNRB, instituted by art. 33 of Law No. 13,123, of 2015, aims to promote:
p.(None): I - conservation of biological diversity;
p.(None): II - recovery, creation and maintenance of ex situ collections of samples of genetic heritage;
p.(None): III - prospection and training of human resources associated with the use and conservation of genetic heritage or associated traditional knowledge;
p.(None): IV - protection, promotion of the use and enhancement of associated traditional knowledge;
p.(None): V - implementation and development of activities related to the sustainable use of biological diversity, its conservation and benefit sharing;
p.(None): VI - fostering research and technological development associated with genetic heritage and associated traditional knowledge;
p.(None): VII - survey and inventory of genetic heritage, considering the situation and the degree of variation of existing populations, including those in use
p.(None): potential and, when feasible, assessing any threats to them;
p.(None): VIII - support for the efforts of indigenous populations, traditional communities and traditional farmers in sustainable management and conservation of
p.(None): genetic heritage;
p.(None): IX - conservation of wild plants;
p.(None): X - development of an efficient and sustainable ex situ and in situ conservation system and development and transfer of appropriate technologies for
p.(None): this purpose with a view to improving the sustainable use of genetic heritage;
p.(None): XI - monitoring and maintaining the viability, the degree of variation and the integrity of the genetic heritage maintained by collections;
p.(None): XII - adoption of measures to minimize or, if possible, eliminate threats to genetic heritage;
p.(None): XIII - development and maintenance of the various cultivation systems that favor the sustainable use of genetic heritage;
p.(None): XIV - elaboration and execution of Sustainable Development Plans for Traditional Populations or Communities; and
p.(None): XV - other actions related to access to genetic heritage and associated traditional knowledge, as defined by the FNRB Management Committee.
p.(None): § 1 The FNRB may support projects and training activities for the employees of the bodies and entities referred to in § 2 of art. 14.
p.(None): § 2 The FNRB may support projects and activities related to the elaboration of community protocols.
p.(None): Art. 101. FNRB resources must be used in the PNRB to support actions and activities that promote the objectives provided for in art. 100, through
...
p.(None): I - affiliation or paternity test, sexing technique and karyotype or DNA analysis and other molecular analyzes aimed at the identification of a species
p.(None): or specimen;
p.(None): II - diagnostic tests and clinical examinations for the direct or indirect identification of aetiological agents or hereditary pathologies in an individual;
p.(None): III - extraction, by means of grinding, pressing or bleeding that results in fixed oils;
p.(None): IV - purification of fixed oils that results in a product whose characteristics are identical to those of the original raw material;
p.(None): V - test that aims to assess mortality rates, growth or multiplication of parasites, pathogens, pests and disease vectors;
p.(None): VI - comparison and extraction of information of genetic origin available in national and international databases
p.(None): VI - extracts processing, physical separation, pasteurization, fermentation, pH assessment, total acidity, soluble solids, bacteria and yeast count,
p.(None): molds, faecal coliforms and totals of genetic heritage samples; and
p.(None): VII - physical, chemical and physical-chemical characterization for determining the nutritional information of foods;
p.(None): Single paragraph. It does not configure access to genetic heritage to read or consult information of genetic origin available in databases
p.(None): national and international, even though they are an integral part of technological research and development.
p.(None): Art. 108. The plant or animal genetic improvement carried out by an indigenous population, traditional community or traditional farmer is exempt from registration in the
p.(None): terms of item VI of art. 10 of Law No. 13,123, of 2015.
p.(None): Art. 109. To comply with the provisions of § 2 of art. 12 of Law No. 13,123, of 2015, the user, when requesting intellectual property rights, must
p.(None): inform whether there was access to genetic heritage or associated traditional knowledge, as well as whether there is an access register carried out under the terms of this Decree.
p.(None): Art. 110. If the registration does not exist or in case of its cancellation, Ibama or CGen will communicate the organ and entity provided for in art. 109 for
p.(None): that the applicant for the intellectual property right to present proof of registration in thirty days, under penalty of
p.(None): intellectual property right application.
p.(None): Single paragraph. In the event of no registration, the period of one year referred to in arts. 36, 37 and 38 of Law No. 13,123, of 2015.
p.(None): Art. 111. CGen, with the collaboration of accredited institutions under the terms of item V of art. 15 of Provisional Measure No. 2,186-16, of 2001, will register in the
p.(None): authorizations already issued.
p.(None): Art. 112. Based on the Common Nomenclature of Mercosur - NCM, the List of Classification of Benefit Sharing referred to in § 9 of art.
p.(None): 17 of Law No. 13,123, of 2015, attached to this Decree.
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Political / criminal
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p.(None): § 3 The sectoral agreement may be extended if the conditions that gave rise to its conclusion are maintained.
p.(None): § 4 The request for extension must be made by the interested party, at least, four months before its end.
p.(None): § 5 During the analysis of the request for extension, the sectoral agreement will remain in force.
p.(None): Art. 66. During the term of the sectoral agreement, the contemplated interested party may request a revision of the rate, provided that at least
p.(None): thirty months from the beginning of the agreement.
p.(None): § 1 The request referred to in the caput must be accompanied by evidence that the circumstances that justified the application of the rate reduction
p.(None): granted at that time have changed.
p.(None): § 2 The analysis of the request for review will follow the provisions of this Section and consider only the new facts that justified the request.
p.(None): Art. 67. The final decision on the request for review will rest with the Minister of State for the Environment and will be limited to the reduction or not of the rate.
p.(None): Art. 68. If the request for review is accepted, an addendum to the sectoral agreement in force will be formalized.
p.(None): Article 69. The Minister of State for the Environment's act shall establish the complementary rules to the provisions of this Section.
p.(None): CHAPTER VI
p.(None): INFRINGEMENTS AND ADMINISTRATIVE SANCTIONS
p.(None): Section I
p.(None): General provisions
p.(None): Art. 70. An administrative infraction against genetic heritage or associated traditional knowledge is considered as provided in arts. 78 to 91 of this Decree.
p.(None): Art. 71. Without prejudice to the applicable criminal and civil responsibilities, administrative infractions will be punished with the following sanctions:
p.(None): I - warning;
p.(None): II - fine;
p.(None): III - seizure:
p.(None): a) samples containing the genetic heritage accessed;
p.(None): b) the instruments used to obtain or process the genetic heritage or associated traditional knowledge accessed;
p.(None): c) products derived from access to genetic heritage or associated traditional knowledge; or
p.(None): d) products obtained from information on associated traditional knowledge;
p.(None): IV - temporary suspension of the manufacture and sale of the finished product or reproductive material derived from access to genetic heritage or knowledge
p.(None): traditional associated until regularization;
p.(None): V - embargo of the specific activity related to the infraction;
p.(None): VI - partial or total interdiction of the establishment, activity or enterprise;
p.(None): VII - suspension of certificate or authorization; or
p.(None): VIII - cancellation of certificate or authorization.
p.(None): Single paragraph. The sanctions provided for in items I to VIII of the caput may be applied cumulatively.
p.(None): Art. 72. The assessing agent, when drawing up the notice of infraction, shall indicate the sanctions established in this Decree, observing:
p.(None): I - the gravity of the fact;
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Political / political affiliation
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p.(None): may exceed the time limit set out in § 2 of art. 12 of Law No. 13,123, of 2015.
p.(None): § 2 The federal bodies and entities for the protection of rights, assistance or promotion of the activities of indigenous populations, traditional communities and
p.(None): Traditional farmers should, at the request of the holders, advise on the activities of obtaining prior informed consent and the negotiation of
p.(None): benefit sharing.
p.(None): § 3 For the purposes of the provisions of § 2, federal bodies and entities may request technical support from CGen's Executive Secretariat.
p.(None): Art. 15. Obtaining prior informed consent from an associated traditional knowledge provider must respect traditional forms of organization
p.(None): and representation of the indigenous population, traditional community or traditional farmer and the respective community protocol, if any.
p.(None): Art. 16. The user must observe the following guidelines for obtaining prior informed consent:
p.(None): I - clarifications to the indigenous population, traditional community or traditional farmer about:
p.(None): a) the social, cultural and environmental impacts resulting from the execution of the activity involving access to associated traditional knowledge;
p.(None): b) the rights and responsibilities of each party in carrying out the activity and its results; and
p.(None): c) the right of the indigenous population, traditional community and traditional farmer to refuse access to associated traditional knowledge;
p.(None): II - establishment, together with the indigenous population, traditional community or traditional farmer, of the benefits sharing modalities,
p.(None): monetary or non-monetary, derived from economic exploitation; and
p.(None): III - respect for the right of the indigenous population, traditional community and traditional farmer to refuse access to associated traditional knowledge, during
p.(None): the prior consent process.
p.(None): Art. 17. Subject to the guidelines referred to in art. 16, the instrument of proof of obtaining prior informed consent will be formalized in
p.(None): language accessible to the indigenous population, the traditional community and the traditional farmer and will contain:
p.(None): I - description of the history of the process for obtaining prior informed consent;
p.(None): II - the description of the traditional forms of organization and representation of the indigenous population, traditional community or traditional farmer;
p.(None): III - the objective of the research, as well as its methodology, duration, budget, possible benefits and sources of financing for the project;
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p.(None): II - information on:
p.(None): a) the type of sample and the form of packaging;
p.(None): b) the number of containers, the volume or the weight;
p.(None): c) the recipient institution abroad, including indication of legal representative and contact information; and
p.(None): d) access activities abroad, including objectives, intended uses and application sector of the research or technological development project;
p.(None): III - Material Transfer Term - TTM, signed between the natural or legal person in Brazil and the legal entity headquartered abroad; and
p.(None): IV - prior informed consent that expressly authorizes the shipment in the case of genetic heritage of a traditional local or creole variety or breed
p.(None): locally adapted or Creole for access in non-agricultural activities, when applicable.
p.(None): § 1 The TTM referred to in item III of the caput must contain:
p.(None): I - the information referred to in items I and II of the caput of this article;
p.(None): II - the obligation to comply with the requirements of Law No. 13,123, of 2015;
p.(None): III - the forecast that:
p.(None): a) the TTM must be interpreted in accordance with Brazilian laws, and, in the event of a dispute, the competent forum is that of Brazil, admitting arbitration agreed between
p.(None): the parts.
p.(None): b) the institution receiving the genetic heritage will not be considered a provider of the genetic heritage; and
p.(None): c) the recipient institution will require a third party to sign a TTM with the obligation to comply with the requirements of Law No. 13,123, 2015, including the
p.(None): provision of line “a” of this item;
p.(None): IV- clause that authorizes or prohibits the transfer of the sample to third parties; and
p.(None): V - information on access to associated traditional knowledge, when applicable.
p.(None): § 2 In the event of authorization referred to in item IV of § 1, the transfer of the sample to third parties will also depend on the signature of the TTM that contains the
p.(None): clauses provided for in § 1.
p.(None): § 3 The provisions of § 2 apply to all subsequent transfers.
p.(None): Art. 26. After completing the form referred to in art. 25 SisGen will automatically issue proof of shipment registration.
p.(None): § 1 The proof of shipment registration constitutes a suitable document to demonstrate that the user provided the information that was required and produces the
p.(None): following effects:
p.(None): I - allows the remittance to take place, under the terms of § 2 of art. 12 of Law No. 13,123, of 2015; and
p.(None): II - establishes the start of the verification procedure provided for in Section VII of this Chapter.
p.(None): § 2 For the purposes of item I of § 1, in addition to the proof of shipment registration, samples must be accompanied by the respective TTM
p.(None): to be sent regularly.
p.(None): § 3 The user will not need to wait for the verification procedure referred to in item II of § 1 to complete before making the shipment.
p.(None): Section IV
p.(None): Authorizations for access to genetic heritage and associated traditional knowledge and
p.(None): remittance abroad, for the cases referred to in art. 13 of Law No. 13,123, of 2015
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p.(None): clarity, loyalty and transparency in the agreed clauses, which should indicate conditions, obligations, types and duration of short, medium and long term benefits,
p.(None): without prejudice to other guidelines and criteria to be established by CGen.
p.(None): Section VI
p.(None): Sectoral agreements
p.(None): Art. 56. The purpose of sectoral agreements is to guarantee the competitiveness of the productive sector in cases where the application of the 1% (one percent) portion of the
p.(None): annual net revenue obtained from the economic exploitation of the finished product or reproductive material arising from access to genetic heritage or knowledge
p.(None): traditional associate of unidentifiable origin characterizes material damage or threat of material damage.
p.(None): § 1 For the purposes of this Decree, the productive sector is the company or group of companies that produce a certain product or similar feature
p.(None): reduction request.
p.(None): Paragraph 2 In the event provided for in the caput, the percentage of payment of monetary benefit sharing may be reduced to up to 0.1% (one tenth percent)
p.(None): of the annual net revenue obtained from economic exploration.
p.(None): Art. 57. The request to reduce the value of the monetary benefit sharing will be addressed to the Ministry of the Environment and will depend on the demonstration that the
p.(None): payment of that percentage has resulted or will result in material damage.
p.(None): § 1 The confidential information contained in the caption referred to in the caput will be treated as so identified by the interested party, provided that the request is
p.(None): justified, and in this case it cannot be revealed without the express authorization of the interested party.
p.(None): § 2 The interested party that provided confidential information must present a summary to be published, with details that allow its understanding, under penalty of being
p.(None): considered non-confidential.
p.(None): § 3 If the Ministry of the Environment considers the request for confidential treatment unjustified and the interested party refuses to adapt it for annexation in
p.(None): non-confidential records, the information will not be known.
p.(None): Art. 58. The request for reduction of benefit sharing will only be known when the signatory companies hold more than:
p.(None): I - fifty percent of the sectorial production value, in the event that said production is concentrated in up to twenty companies; and
p.(None): II - twenty-five percent of the sectorial production value, in the event that said production is concentrated in more than twenty companies.
p.(None): § 1 For the purposes of this article, the sectorial production value is the estimate of the national production value of the finished product or reproductive material
p.(None): arising from access to genetic heritage or associated traditional knowledge of unidentifiable origin as characterized in the reduction request.
p.(None): § 2 The request must be signed by the legal representatives of each of the signatories and will contain:
p.(None): I - documents proving the causal link between the material damage or its threat and the payment of the monetary benefit sharing corresponding to
p.(None): share of 1% (one percent) of annual net revenue; and
p.(None): II - characterization of the finished product or reproductive material for which the reduction of the 1% (one percent) portion provided for in art. 56.
p.(None): § 3 The characterization indicated in item II of § 2 will include the following information:
p.(None): I - accessed genetic heritage;
p.(None): II - associated traditional knowledge accessed;
p.(None): III - raw materials;
p.(None): IV - chemical composition;
p.(None): V - physical characteristics;
p.(None): VI - standards and technical specifications;
...
p.(None): I - the Ministry of Development, Industry and Foreign Trade; and
p.(None): II - the official bodies for the defense of the rights of indigenous peoples, traditional communities or traditional farmers, when presented.
p.(None): Paragraph 1 Interested companies will be notified to, within thirty days, comment on the opinion referred to in the caput.
p.(None): § 2 The Ministry of the Environment may accept the statements of interested companies, at which time it will issue a new opinion.
p.(None): Art. 63. The opinion will be submitted to the Minister of State for the Environment, who will decide, on a motivated basis, on the realization or not of the sectoral agreement.
p.(None): Art. 64. The terms of the sectoral agreement in force apply to all products produced in the national territory that fall under the terms of the decision, even
p.(None): produced by companies that have not subscribed to the reduction request.
p.(None): Art. 65. The sectoral agreement will be in force for sixty months from the publication of the decision referred to in art. 63.
p.(None): § 1 In the event of a sectoral agreement in force at the time of payment of the benefit sharing referring to a given finished product or
p.(None): reproductive material, the rate to be paid will be that defined in the sectoral agreement.
p.(None): § 2 After the term referred to in the caput has elapsed, and if there is no request for extension, the sectoral agreement will be terminated.
p.(None): § 3 The sectoral agreement may be extended if the conditions that gave rise to its conclusion are maintained.
p.(None): § 4 The request for extension must be made by the interested party, at least, four months before its end.
p.(None): § 5 During the analysis of the request for extension, the sectoral agreement will remain in force.
p.(None): Art. 66. During the term of the sectoral agreement, the contemplated interested party may request a revision of the rate, provided that at least
p.(None): thirty months from the beginning of the agreement.
p.(None): § 1 The request referred to in the caput must be accompanied by evidence that the circumstances that justified the application of the rate reduction
p.(None): granted at that time have changed.
p.(None): § 2 The analysis of the request for review will follow the provisions of this Section and consider only the new facts that justified the request.
p.(None): Art. 67. The final decision on the request for review will rest with the Minister of State for the Environment and will be limited to the reduction or not of the rate.
p.(None): Art. 68. If the request for review is accepted, an addendum to the sectoral agreement in force will be formalized.
p.(None): Article 69. The Minister of State for the Environment's act shall establish the complementary rules to the provisions of this Section.
p.(None): CHAPTER VI
p.(None): INFRINGEMENTS AND ADMINISTRATIVE SANCTIONS
p.(None): Section I
p.(None): General provisions
p.(None): Art. 70. An administrative infraction against genetic heritage or associated traditional knowledge is considered as provided in arts. 78 to 91 of this Decree.
p.(None): Art. 71. Without prejudice to the applicable criminal and civil responsibilities, administrative infractions will be punished with the following sanctions:
p.(None): I - warning;
p.(None): II - fine;
p.(None): III - seizure:
p.(None): a) samples containing the genetic heritage accessed;
p.(None): b) the instruments used to obtain or process the genetic heritage or associated traditional knowledge accessed;
...
p.(None): application of the aggravation of the new penalty.
p.(None): Paragraph 3. The existence of an infraction notice previously confirmed in judgment, the environmental authority shall:
p.(None): I - aggravate the penalty as provided in the caput;
p.(None): II - notify the assessed person so that he / she can express his opinion about the increase in the penalty within ten days; and
p.(None): III - judge the new infraction considering the increase in the penalty.
p.(None): Art. 75. For the sanctions provided for in items III to VI of art. 71, the provisions of Decree No. 6,514, of July 22, 2008, apply as appropriate.
p.(None): Section II
p.(None): Limitation periods
p.(None): Art. 76. Under the terms of Law No. 9,873, of November 23, 1999, the public administration prescribes the action of five years in order to investigate the practice of
p.(None): administrative infractions against genetic heritage and associated traditional knowledge, counted from the date of practice of the act, or, in the case of permanent infraction or
p.(None): continued, from the day it has ceased.
p.(None): § 1 The investigation of the infraction against the genetic heritage and the traditional knowledge associated with the drawing up of the infraction notice by the
p.(None): competent authority or administrative notification.
p.(None): § 2 The intercurrent prescription applies to the procedure for determining the infraction notice that has been paralyzed for more than three years, pending judgment or order,
p.(None): whose records will be filed by letter or at the request of the interested party, without prejudice to the determination of the functional responsibility arising from the
p.(None): stoppage.
p.(None): Art. 77. The prescription is interrupted:
p.(None): I - for making the offender aware by any means, including by public notice;
p.(None): II - for any unequivocal act of the public administration that requires investigation of the fact; and
p.(None): III - by the appellate condemnatory decision.
p.(None): Single paragraph. An unambiguous act of the public administration is considered, for the purpose of the provision of item II, one that implies instruction of the process.
p.(None): Section III
p.(None): Infractions against genetic heritage and associated traditional knowledge
p.(None): Art. 78. Economically exploiting finished product or reproductive material from access to genetic heritage or associated traditional knowledge without
p.(None): prior notification.
p.(None): Minimum fine of R $ 3,000.00 (three thousand reais) and maximum fine of R $ 30,000.00 (thirty thousand reais), in the case of a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of December 14, 2006.
p.(None): Minimum fine of R $ 30,000.00 (thirty thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
...
Health / Drug Usage
Searching for indicator substance:
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p.(None): II - reproductive material arising from access to genetic heritage or associated traditional knowledge for the purpose of agricultural activities carried out after the
p.(None): of Law No. 13,123, of 2015.
p.(None): § 1 In the case of the finished product referred to in item I of the caput, the component of genetic heritage or associated traditional knowledge must be one of the
p.(None): main elements of added value.
p.(None): § 2 Under the terms of item XVIII of art. 2 of Law No. 13,123, of 2015, the main elements of added value are the elements whose
p.(None): presence in the finished product is decisive for the existence of functional characteristics or for the formation of market appeal.
p.(None): § 3 For the purposes of this Decree, the following are considered:
p.(None): I - marketing appeal: reference to genetic heritage or associated traditional knowledge, its origin or the differences resulting from it,
p.(None): related to a product, product line or brand, in any visual or auditory media, including marketing campaigns or label prominence
p.(None): of product; and
p.(None): II - functional characteristics: characteristics that determine the main purposes, improve the action of the product or expand its list of purposes.
p.(None): § 4 The use of genetic heritage, exclusively as excipients, will not be considered determinant for the existence of functional characteristics.
p.(None): vehicles or other inert substances, which do not determine functionality.
p.(None): § 5 The substance derived from the metabolism of microorganism will not be considered determinant for the existence of functional characteristics when it is
p.(None): identical to the substance of fossil origin already existing and used instead.
p.(None): § 6 SisGen will provide a specific field in the access register referred to in art. 22 so that the user, if interested, indicates and proves the
p.(None): framing the situation described in § 5.
p.(None): Art. 44. The manufacturer of the finished product or the producer of reproductive material is subject to the sharing of benefits, regardless of
p.(None): who has previously accessed.
p.(None): § 1 In the case of agricultural activity, the sharing of benefits will be due by the producer responsible for the last link in the productive chain of material
p.(None): reproductive.
p.(None): § 2 for the purposes of § 1, the producer responsible for selling reproductive material for production is considered the last link in the production chain,
p.(None): processing and marketing of food, beverages, fibers, energy and planted forests.
p.(None): § 3 In the case of economic exploitation of reproductive material arising from access to genetic heritage or associated traditional knowledge for the purposes of
p.(None): agricultural activities and destined exclusively to the generation of finished products in production chains that do not involve agricultural activity, the
p.(None): benefits will only occur on the economic exploitation of the finished product.
p.(None): Art. 45. The calculation of the net revenue referred to in arts. 20, 21 and 22 of Law No. 13,123, of 2015, will be carried out as determined in § 1 of art. 12 of Decree-Law no.
p.(None): 1,598, of December 26, 1977.
p.(None): § 1 For the purposes of the caput, the manufacturer of the finished product or producer of the reproductive material must declare the annual net revenue for each year
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): I - one representative from each of the following ministries:
p.(None): a) Ministry of the Environment;
p.(None): b) Ministry of Justice;
p.(None): c) Ministry of Health;
p.(None): d) Ministry of Foreign Affairs;
p.(None): e) Ministry of Agriculture, Livestock and Supply;
p.(None): f) Ministry of Culture;
p.(None): g) Ministry of Social Development and Fight against Hunger;
p.(None): h) Ministry of Defense;
p.(None): i) Ministry of Development, Industry and Foreign Trade;
p.(None): j) Ministry of Science, Technology and Innovation; and
p.(None): k) Ministry of Agrarian Development;
p.(None): II - three representatives of entities or organizations in the business sector, being:
p.(None): a) one appointed by the National Confederation of Industry - CNI;
p.(None): b) one nominated by the National Agriculture Confederation - CNA; and
p.(None): c) one nominated alternatively and successively by CNI and CNA;
p.(None): III - three representatives of entities or organizations in the academic sector, being:
p.(None): a) one nominated by the Brazilian Society for the Progress of Science - SBPC;
p.(None): b) one nominated by the Brazilian Association of Anthropology - ABA; and
p.(None): c) one nominated by the Brazilian Academy of Sciences - ABC; and
p.(None): IV - three representatives of entities or organizations representing indigenous populations, traditional communities and traditional farmers, being:
p.(None): a) one appointed by representatives of traditional peoples and communities and their organizations of the National Council of Traditional Peoples and Communities -
p.(None): CNPCT;
p.(None): b) one appointed by representatives of family farmers and their organizations from the National Council for Sustainable Rural Development - Condraf; and
p.(None): c) one nominated by representatives of indigenous peoples and organizations that are members of the National Council for Indigenous Policy - CNPI.
p.(None): § 1 CGen will be chaired by the senior adviser to the Ministry of the Environment and, in his impediments or absences, by the respective alternate.
p.(None): § 2 The representations referred to in this article shall consist of one holder and two alternates each, who will be appointed by the holder of the management bodies
p.(None): federal government and the respective legal representatives of civil society entities or organizations.
p.(None): § 3 The members of the CGen, members and alternates, will be appointed in an act of the Minister of State for the Environment, within thirty days of receiving the
p.(None): indications.
p.(None): § 4 The CGen Plenary will meet with the presence of at least eleven directors, and its decisions will be taken by a simple majority.
p.(None): Paragraph 5. The duties of the directors will not be remunerated and their exercise is considered a relevant public service, with the responsibility of public bodies and entities
p.(None): representatives of civil society defray the travel and subsistence expenses of their respective representatives.
p.(None): § 6 The Union will be responsible for defraying the travel and subsistence expenses of the members referred to in item IV of the caput.
p.(None): Section III
p.(None): Thematic Chambers and Sectorial Chambers
p.(None): Art. 8 Thematic Chambers will be created by CGen to support the decisions of the Plenary based on technical discussions and presentation of proposals on
...
p.(None): § 1 In the benefit sharing agreements implemented through the instruments referred to in items “a”, “e” and “f” of item II of art. 19, of Law nº
p.(None): 13,123, from 2015, the breakdown will be equivalent to seventy-five percent of the forecast for the monetary modality.
p.(None): § 2 In the benefit sharing agreements implemented by means of instruments not provided for in § 1, the allocation will be equivalent to the amount provided for
p.(None): the monetary modality.
p.(None): § 3 The project management expenses, including planning, and accountability, cannot be counted to achieve the percentage provided for in §§
p.(None): 1st and 2nd.
p.(None): § 4 For the purpose of proving the equivalence referred to in §§ 1 and 2, the user must present an estimate, based on market values.
p.(None): § 5 The benefit sharing agreements entered into by the Union will be implemented, preferably, through the instrument referred to in item “a”
p.(None): of item II of art. 19, of Law No. 13,123, of 2015.
p.(None): § 6 The user may not use non-monetary benefit sharing resources in marketing campaigns or any other form of advertising in
p.(None): benefit of your products, product lines or brands.
p.(None): Art. 51. In the case of item II of art. 50, the non-monetary benefit sharing referred to in items “a” and “e” of item II of art. 19 of Law No. 13,123, of
p.(None): 2015, will be aimed at:
p.(None): I - conservation units;
p.(None): II - indigenous lands;
p.(None): III - remaining quilombo territories;
p.(None): IV - rural settlement of family farmers;
p.(None): V - traditional territories under the terms of Decree No. 6,040, of February 7, 2007;
p.(None): VI - national public research and development institutions;
p.(None): VII - priority areas for conservation, sustainable use and benefit sharing of Brazilian biodiversity, as per the act of the Minister of State of
p.(None): Environment;
p.(None): VIII - activities related to the safeguarding of associated traditional knowledge;
p.(None): IX - ex situ collections maintained by accredited institutions under the terms of Chapter IV, Section V; and
p.(None): X - indigenous populations, traditional communities and traditional farmers.
p.(None): Art. 52. In the case of item II of art. 50 the sharing of non-monetary benefits referred to in points “b”, “c”, “d” and “f” of item II of art. 19 of Law nº
p.(None): 13,123, from 2015, will be destined to national public bodies and institutions that execute social interest programs.
p.(None): Art. 53. The Ministry of the Environment may create and maintain the bank of proposals for the sharing of non-monetary benefits, which will be widely publicized,
p.(None): including through its website, to comply with the provisions of item II of art. 19 of Law No. 13,123 of 2015.
p.(None): Single paragraph. The proposals referred to in the caput should be aimed at the conservation and sustainable use of biodiversity, valuing and protecting the
p.(None): associated traditional knowledge, serving the public interest.
p.(None): Section IV
p.(None): Exemptions from benefit sharing
p.(None): Art. 54. Economic exploitation of:
p.(None): I - finished product or reproductive material developed by traditional farmers and their cooperatives, with annual gross revenue equal to or less than the limit
...
Health / alcoholism
Searching for indicator alcoholic:
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p.(None): Paragraph 1 The deadline for registration or notification referred to in the caput will be 1 (one) year, counted from the date the registration is made available by CGen.
p.(None): § 2 Once the registration or notification is made in a timely manner, the user will not be subject to administrative sanction.
p.(None): Art. 119. The following are revoked:
p.(None): I - Decree No. 3,945, of September 28, 2001;
p.(None): II - Decree No. 4,946, of December 31, 2003;
p.(None): III - Decree No. 5,459, of June 7, 2005;
p.(None): IV - Decree No. 6,159, of July 17, 2007; and
p.(None): V - Decree No. 6,915, of July 29, 2009.
p.(None): Art. 120. This Decree comes into force on the date of its publication.
p.(None): Brasília, May 11, 2016; 195th of Independence and 128th of the Republic.
p.(None): DILMA ROUSSEFF
p.(None): Eugênio José Guilherme de Aragão
p.(None): Kátia Abreu
p.(None): Fernando de Magalhães Furlan
p.(None): João Luiz Silva Ferreira
p.(None): Izabella Mônica Vieira Teixeira
p.(None): Patrus Ananias
p.(None): This text does not replace the one published in the DOU of 12.5.2016
p.(None): ATTACHMENT
p.(None): Benefit Sharing Classification List
p.(None): NCM Chapters Section
p.(None): Section I. LIVE ANIMALS AND PRODUCTS Chapters 1 to 5 01.01 to 0508.00.00
p.(None): OF THE ANIMAL KINGDOM
p.(None): Section II. KINGDOM PRODUCTS Chapters 6 to 14 06.01 to 14.04
p.(None): VEGETABLE
p.(None): Section III. FATS AND OILS Chapters 15 15.01 to 15.15
p.(None): ANIMALS OR VEGETABLES; PRODUCTS
p.(None): YOUR
p.(None): DISSOCIATION; FATS
p.(None): PREPARED FOODS;
p.(None): ANIMAL OR WAXES
p.(None): VEGETABLE
p.(None): Section IV. PRODUCTS FROM Chapters 16 to 24 1601.00.00 to 24.03
p.(None): FOOD INDUSTRIES;
p.(None): BEVERAGES, ALCOHOLIC LIQUIDS AND
p.(None): VINEGARS;
p.(None): TOBACCO AND ITS SUCCESSFUL
p.(None): MANUFACTURED
p.(None): Section VI. PRODUCTS OF Chapters 28 to 38 28.01 to 38.25
p.(None): CHEMICAL INDUSTRIES
p.(None): OR RELATED INDUSTRIES
p.(None): Section VII. PLASTICS AND THEIR CHAPTERS 39 TO 40 39.01 TO 4017.00.00
p.(None): CONSTRUCTION;
p.(None): RUBBER AND ARTICLES THEREOF
p.(None): Section VIII. FUR, LEATHER, FUR Chapters 41 to 43 41.01 to 43.03
p.(None): WITH HAIR AND WORKS
p.(None): THESE MATTERS; ARTICLES
p.(None): CORREEIRO
p.(None): OR SEARCH; ARTICLES
p.(None): TRAVEL, BAGS
p.(None): AND SIMILAR ARTICLES; CONSTRUCTION
p.(None): TRIPLE
p.(None): Section IX. WOOD, COAL Chapters 44 to 45 44.01 to 45.04
p.(None): VEGETABLE AND WOODEN WORKS;
p.(None): CORK AND ARTICLES THEREOF;
p.(None): SPECIALTY OR CONSTRUCTION WORKS
p.(None): WAREHOUSE
p.(None): Section X. WOODEN OR CHAPTER FOLDERS 46 to 49 46.01 to 4907.00
p.(None): OTHER FIBROUS MATERIALS
p.(None): CELLULOSIS;
p.(None): PAPER OR CARD FOR RECYCLING
p.(None): (WASTE AND TRIMS);
p.(None): PAPER OR CARDBOARD AND ARTICLES THEREOF
p.(None): Section XI. TEXTILE MATERIALS AND THEIR Chapters 50 to 63 5001.00.00 to 63.10
p.(None): CONSTRUCTION
p.(None): Section XII. FOOTWEAR, HATS AND CHAPTERS 64 to 67 64.01 to 67.04
p.(None): SIMILAR USE ARTIFACTS,
p.(None): UMBRELLA,
p.(None): SUNSCREEN, WALKING BOATS,
p.(None): WHIPPERS AND PARTS THEREOF; FEATHERS
p.(None): PREPARED AND
p.(None): YOUR WORKS; ARTIFICIAL FLOWERS;
p.(None): HAIR WORKS
p.(None): Section XIV. NATURAL PEARLS OR 71. Natural or cultured pearls, - 71.01. Natural or cultured pearls,
p.(None): CULTIVATED, PRECIOUS STONES OR precious or semi-precious stones and even worked or combined, but
p.(None): not threaded, nor assembled, nor
p.(None): SEMI-PRECIOUS AND SIMILAR, similar, precious metals, set metals; natural pearls or
...
Health / patients in emergency situations
Searching for indicator emergencyXsituation:
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p.(None): Art. 111. CGen, with the collaboration of accredited institutions under the terms of item V of art. 15 of Provisional Measure No. 2,186-16, of 2001, will register in the
p.(None): authorizations already issued.
p.(None): Art. 112. Based on the Common Nomenclature of Mercosur - NCM, the List of Classification of Benefit Sharing referred to in § 9 of art.
p.(None): 17 of Law No. 13,123, of 2015, attached to this Decree.
p.(None): Single paragraph. The list referred to in the caput will have an exemplary character and will not exclude the application of the benefit sharing incidence rules
p.(None): provided for in arts. 17 and 18 of Law No. 13,123, of 2015.
p.(None): Art. 113. The Ministry of Agriculture, Livestock and Supply will periodically prepare, publish and review the reference list of animal and plant species
p.(None): domesticated or cultivated that were introduced in the national territory, used in agricultural activities.
p.(None): Single paragraph. The list referred to in the caput will indicate the species that form spontaneous populations and the varieties that have acquired properties
p.(None): distinctive characteristics in the country.
p.(None): Art. 114. Joint act of the Ministers of State for Agriculture, Livestock and Supply and Agrarian Development will publish a list of traditional varieties
p.(None): local or Creole and locally adapted or Creole breeds.
p.(None): Art. 115. The Ministry of Health and the Ministry of the Environment, in a joint Ordinance, will regulate a simplified procedure for carrying out remittances.
p.(None): genetic heritage related to the Public Health Emergency Situation of National Importance - ESPIN, which is dealt with in Decree nº 7.616, of November 17,
p.(None): 2011.
p.(None): § 1 The consignment provided for in the caput will be destined exclusively to research and technological development declared in the Material Transfer Term,
p.(None): necessarily linked to the epidemiological situation, and the use of this genetic heritage accessed for other purposes is prohibited.
p.(None): § 2 The benefits resulting from the economic exploitation of the finished product or reproductive material arising from research or technological development that
p.(None): this article deals with will be distributed under the terms of Law No. 13,123, 2015, and this Decree.
p.(None): Art. 116. The Ministry of the Environment, in coordination with the Ministry of Foreign Affairs, may enter into cooperation agreements and agreements with
p.(None): entities in other countries for the purpose of complying with the provisions of Law No. 13,123 of 2015.
p.(None): Art. 117. The provisions of this Decree do not exclude the powers of the Ministry of Science, Technology and Innovation to supervise and control the activities of
p.(None): scientific research in the national territory, when carried out by foreigners, which imply entering the country.
p.(None): Art. 118. The user who requested any intellectual property right, economically exploited the finished product or reproductive material, or disclosed
p.(None): results, final or partial, in scientific or communication media, between November 17, 2015 and the date of availability of the registration, must register the
p.(None): activities referred to in art. 12 of Law No. 13,123, 2015 and notify the finished product or reproductive material developed as a result of access.
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): Presidency of the Republic
p.(None): General secretary
p.(None): Sub-branch for Legal Affairs
p.(None): DECREE No. 8.772, OF MAY 11, 2016
p.(None): Regulates Law No. 13,123, of May 20, 2015, which provides for access
p.(None): genetic heritage, protection and access to traditional knowledge
p.(None): and the sharing of benefits for conservation and sustainable use
p.(None): biodiversity.
p.(None): THE PRESIDENT OF THE REPUBLIC, using the powers conferred on her by art. 84, caput, item IV and item VI, item “a”, of the Constitution, and in view of the
p.(None): provided for in Law No. 13,123, of May 20, 2015,
p.(None): DECREE:
p.(None): CHAPTER I
p.(None): PRELIMINARY PROVISIONS
p.(None): Art. 1 This Decree regulates Law No. 13,123, of May 20, 2015, which provides for access to genetic heritage, protection and access to
p.(None): associated traditional knowledge and benefit sharing for conservation and sustainable use of biodiversity.
p.(None): § 1 The part of the genetic heritage existing in the national territory is considered, for the purposes of this Decree, the microorganism that has been isolated from
p.(None): substrates of the national territory, the territorial sea, the exclusive economic zone or the continental shelf.
p.(None): § 2 The microorganism will not be considered a national genetic heritage when the user, upon request by the competent authority, proves:
p.(None): I - that was isolated from substrates that are not from the national territory, the territorial sea, the exclusive economic zone or the continental shelf; and
p.(None): II - the regularity of its import.
p.(None): § 3 The plant and animal species introduced in the Country will only be considered genetic heritage found in conditions in situ in the national territory
p.(None): when they form spontaneous populations that have acquired their own distinctive characteristics in the country.
p.(None): § 4 The genetic heritage found in situ conditions is also considered to be the variety from a species introduced in the national territory with
p.(None): genetic diversity developed or adapted by indigenous populations, traditional communities or traditional farmers, including combined natural selection
p.(None): with human selection in the local environment, which is not substantially similar to commercial cultivars.
p.(None): Art. 2 The following activities are subject to the requirements of Law No. 13,123, 2015, and this Decree:
p.(None): I - access to genetic heritage or associated traditional knowledge;
p.(None): II - sending samples of genetic heritage abroad; and
p.(None): III - economic exploitation of finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge
p.(None): carried out after the entry into force of Law No. 13,123, of 2015.
p.(None): § 1 For the purposes of the provision in item II of the caput, the practice of any research or technological development activity that is carried out after 17
p.(None): November 2015, will be, regardless of the date of its beginning, considered as access made after the entry into force of Law No. 13,123, of 2015.
p.(None): § 2 The activities carried out between June 30, 2000 and November 17, 2015 must comply with the provisions of Chapter VIII of this Decree.
p.(None): Art. 3 The access to genetic heritage or associated traditional knowledge is not subject to the requirements of Law No. 13,123, 2015
p.(None): completed before June 30, 2000 and the economic exploitation of the finished product or reproductive material resulting therefrom.
p.(None): § 1 For the purposes of the caput, and when requested by the competent authority, the user must prove that all stages of access have ended
p.(None): before June 30, 2000.
p.(None): § 2 The proof referred to in § 1 must occur through:
p.(None): I - in the case of research:
p.(None): a) publication of an article in a scientific journal;
p.(None): b) communication at scientific events;
p.(None): c) filing a patent application;
p.(None): d) report of completion of the research with a public funding agency or entity; or
p.(None): e) publication of course completion papers, master's dissertations, doctoral theses; and
p.(None): II - in the case of technological development:
p.(None): a) filing a patent application;
p.(None): b) cultivar registration;
p.(None): c) product registration with public agencies; or
p.(None): d) proof of commercialization of the product.
p.(None): § 3 In the case of economic exploitation of finished product or reproductive material, in addition to the provisions of items I and II of § 2, the user must prove
p.(None): that the completed access was sufficient to obtain the finished product or reproductive material subject to economic exploitation.
p.(None): § 4 For the purposes of § 3, it is considered that the completed access was sufficient to obtain the finished product or reproductive material object of the exploration
p.(None): when there is no research or technological development activity after June 30, 2000.
p.(None): § 5 The Genetic Heritage Management Council may:
p.(None): I - define other means of proof in addition to those provided for in items I and II of § 2; and
p.(None): II - issue, upon request and proof, a document attesting to the user's qualification in the situations provided for in this article.
p.(None): CHAPTER II
p.(None): OF THE GENETIC HERITAGE MANAGEMENT COUNCIL - CGEN
p.(None): Section I
p.(None): General provisions
p.(None): Art. 4 The Genetic Heritage Management Council - CGen, a collegiate body of a deliberative, normative, advisory and appeal nature, has the following
p.(None): Skills:
p.(None): I - coordinate the development and implementation of policies for the management of access to genetic heritage and associated traditional knowledge and the
p.(None): benefit sharing;
p.(None): II - establish:
p.(None): a) technical standards;
p.(None): b) guidelines and criteria for drawing up and complying with the benefit-sharing agreement; and
p.(None): c) criteria for the creation of a database for recording information on genetic heritage and associated traditional knowledge;
p.(None): III - monitor, in conjunction with federal agencies, or through an agreement with other institutions, the activities of:
p.(None): a) access and shipment of a sample containing the genetic heritage; and
p.(None): b) access to associated traditional knowledge;
p.(None): IV - deliberate on:
p.(None): a) the accreditation of a national institution that maintains an ex situ collection of samples containing the genetic heritage; be them:
p.(None): 1. public; or
p.(None): 2. non-profit private companies that maintain popular herbariums or community seed banks; and
p.(None): b) the accreditation of a national public institution to be responsible for the creation and maintenance of the database referred to in item X;
p.(None): V - certify the regularity of access to genetic heritage or associated traditional knowledge referred to in Chapter IV of Law No. 13,123, of 2015;
p.(None): VI - record 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.
p.(None): 16 of Law No. 13,123, of 2015;
p.(None): VII - promote public debates and consultations on the topics covered by Law No. 13,123, of 2015;
p.(None): VIII - to function as a higher level of appeal in relation to the decision of an accredited institution and the acts resulting from the application of Law No. 13,123, of 2015
p.(None): ;
p.(None): IX - establish guidelines for the application of the resources destined to the National Fund for the Sharing of Benefits - FNRB, by way of sharing of
p.(None): benefits;
p.(None): X - create and maintain a relative database:
p.(None): a) records of access to genetic heritage or associated traditional and referral knowledge;
p.(None): b) authorizations for access to genetic heritage or associated traditional and referral knowledge;
p.(None): c) instruments and material transfer terms for sending samples and shipments;
p.(None): d) the ex situ collections of accredited institutions that contain samples of genetic heritage;
p.(None): e) notifications of finished product or reproductive material;
p.(None): f) benefit sharing agreements; and
p.(None): g) certificates of regularity of access;
p.(None): XI - scienti fi c federal agencies to protect the rights of indigenous populations, traditional communities and traditional farmers on registration in
p.(None): registration of access to associated traditional knowledge; and
p.(None): XII - approve its internal regulations, which shall provide, at least, about:
p.(None): a) organization and functioning of its meetings;
p.(None): b) functioning of the Executive Secretariat;
p.(None): c) procedure for the appointment of its Directors;
p.(None): d) removal, impediment, suspicion and hypotheses of conflict of interests of the Directors;
p.(None): e) publicizing its technical standards and resolutions; and
p.(None): f) composition and functioning of the Thematic and Sectorial Chambers.
p.(None): Single paragraph. CGen may, at the user's request, issue an internationally recognized certificate of compliance that will serve as proof that
p.(None): activities on genetic heritage or associated traditional knowledge were carried out in accordance with Law No. 13,123 of 2015 and this Decree.
p.(None): Art. 5 Without prejudice to the System provided for in Chapter IV of this Decree, CGen shall maintain its own system for traceability of activities resulting from
p.(None): access to genetic heritage or associated traditional knowledge, including those related to economic exploitation.
p.(None): § 1 Under the terms of art. 7 of Law No. 13,123 of 2015, the system provided for in the caput will be managed by the Executive Secretariat of CGen and will have the
p.(None): information necessary for the traceability of activities resulting from access to genetic heritage or associated traditional knowledge
p.(None): systems databases:
p.(None): I - protection and registration of cultivars, seeds and seedlings, agricultural products, establishments and inputs, traffic information
p.(None): international agricultural products and inputs from the Ministry of Agriculture, Livestock and Supply;
p.(None): II - import and export registration under the Integrated Foreign Trade System - Siscomex, instituted by Decree No. 660, of September 25,
p.(None): 1992;
p.(None): III - information on curricula, research groups, institutions registered on the Lattes Platform of the National Council for Scientific Development and
p.(None): Technological - CNPq;
p.(None): IV - information on research and commercial release of genetically modified organisms and derivatives, from the National Technical Commission for
p.(None): Biosafety - CTNBio from the Ministry of Science, Technology and Innovation;
p.(None): V - registration of products from the National Health Surveillance Agency - Anvisa;
p.(None): VI - granting and guaranteeing intellectual property rights of the National Institute of Industrial Property - INPI;
p.(None): VII - national register of social information of the Ministry of Social Development and Fight against Hunger; and
p.(None): VIII - information on cultural heritage of the National Information and Cultural Indicators System - SNIIC, of the Ministry of Culture.
p.(None): § 2 The bodies and entities referred to in this article shall adopt the necessary measures to guarantee access to information through the traceability system and the
p.(None): Ministry of the Environment will adopt the necessary measures for the integration of the information contained in the databases provided for in § 1.
p.(None): § 3 In the impossibility of adopting the measures provided for in § 2, the information must be forwarded to CGen within thirty days, counted from the
p.(None): solicitation.
p.(None): § 4 CGen may also:
p.(None): I - request additional information from the bodies and entities provided for in § 1;
p.(None): II - to request other organs and entities of the federal public administration information that it deems necessary for the traceability of activities
p.(None): arising from access to genetic heritage or associated traditional knowledge; and
p.(None): III - adopt measures to guarantee access to information through the traceability system and the integration of databases with different bodies and entities
p.(None): those provided for in items I to VIII of §1 of the caput.
p.(None): § 5 The bodies and entities of the federal public administration that provide confidential information to CGen shall indicate this circumstance
p.(None): express, specifying, when applicable, the classification of the information regarding the degree and term of confidentiality, in accordance with the provisions of Law No. 12,527, of November 18,
p.(None): 2011, or in specific legislation.
p.(None): § 6 The Executive Secretariat of CGen will ensure the legal confidentiality of information, respecting the classification of information regarding the degree and term of confidentiality,
p.(None): When it's the case.
p.(None): § 7 For the purposes of the caput, CGen may have access to the data contained in systems of the Secretariat of the Federal Revenue of Brazil contained in
p.(None): public domain registration and that do not inform the taxpayers' economic or financial situation.
p.(None): Art. 6 CGen will operate through:
p.(None): I - Plenary;
p.(None): II - Thematic Chambers;
p.(None): III - Sectorial Chambers; and
p.(None): IV - Executive Secretariat.
p.(None): Section II
p.(None): From the Plenary
p.(None): Article 7. The CGen Plenary will be composed of twenty-one members, twelve representatives of federal public administration bodies and nine
p.(None): representatives of civil society, distributed as follows:
p.(None): I - one representative from each of the following ministries:
p.(None): a) Ministry of the Environment;
p.(None): b) Ministry of Justice;
p.(None): c) Ministry of Health;
p.(None): d) Ministry of Foreign Affairs;
p.(None): e) Ministry of Agriculture, Livestock and Supply;
p.(None): f) Ministry of Culture;
p.(None): g) Ministry of Social Development and Fight against Hunger;
p.(None): h) Ministry of Defense;
p.(None): i) Ministry of Development, Industry and Foreign Trade;
p.(None): j) Ministry of Science, Technology and Innovation; and
p.(None): k) Ministry of Agrarian Development;
p.(None): II - three representatives of entities or organizations in the business sector, being:
p.(None): a) one appointed by the National Confederation of Industry - CNI;
p.(None): b) one nominated by the National Agriculture Confederation - CNA; and
p.(None): c) one nominated alternatively and successively by CNI and CNA;
p.(None): III - three representatives of entities or organizations in the academic sector, being:
p.(None): a) one nominated by the Brazilian Society for the Progress of Science - SBPC;
...
p.(None): c) one nominated by representatives of indigenous peoples and organizations that are members of the National Council for Indigenous Policy - CNPI.
p.(None): § 1 CGen will be chaired by the senior adviser to the Ministry of the Environment and, in his impediments or absences, by the respective alternate.
p.(None): § 2 The representations referred to in this article shall consist of one holder and two alternates each, who will be appointed by the holder of the management bodies
p.(None): federal government and the respective legal representatives of civil society entities or organizations.
p.(None): § 3 The members of the CGen, members and alternates, will be appointed in an act of the Minister of State for the Environment, within thirty days of receiving the
p.(None): indications.
p.(None): § 4 The CGen Plenary will meet with the presence of at least eleven directors, and its decisions will be taken by a simple majority.
p.(None): Paragraph 5. The duties of the directors will not be remunerated and their exercise is considered a relevant public service, with the responsibility of public bodies and entities
p.(None): representatives of civil society defray the travel and subsistence expenses of their respective representatives.
p.(None): § 6 The Union will be responsible for defraying the travel and subsistence expenses of the members referred to in item IV of the caput.
p.(None): Section III
p.(None): Thematic Chambers and Sectorial Chambers
p.(None): Art. 8 Thematic Chambers will be created by CGen to support the decisions of the Plenary based on technical discussions and presentation of proposals on
p.(None): specific themes or areas of knowledge related to access and benefit sharing.
p.(None): § 1 The act of creating the Thematic Chambers will provide for their attributions, duration and composition, which must observe the proportion of:
p.(None): I - fifty percent of representatives of federal public administration bodies and entities with competences related to the subject of the respective Chamber;
p.(None): II - twenty-five percent of organizations representing the user sector; and
p.(None): III - twenty-five percent of organizations representing associated traditional knowledge providers.
p.(None): § 2 The CGen may create a special Thematic Chamber to analyze and support the Plenary's judgment of appeals filed as a last resort.
p.(None): Art. 9 The Sectorial Chambers will be created by CGen to support the decisions of the Plenary based on technical discussions and presentation of proposals for
p.(None): interest of the business and academic sectors, as well as of indigenous populations, traditional communities and traditional farmers.
p.(None): Single paragraph. The act of creation of the Sectorial Chambers will provide for their attributions, duration and composition, which must observe parity between
p.(None): representation of federal public administration bodies and entities with competences related to the respective Chamber and the civil society sector
p.(None): corresponding.
p.(None): Art. 10. The members of the Thematic Chambers and the Sectorial Chambers will be appointed by the members of the Plenary of CGen, considering the formation, the
p.(None): performance or notorious knowledge in the area related to the Chamber's competences.
p.(None): Section IV
p.(None): The Executive Secretariat
p.(None): Art. 11. The Executive Secretariat of CGen is responsible for:
p.(None): I - provide technical and administrative support to the Plenary of CGen and its Chambers;
p.(None): II - promote the instruction and processing of the processes to be submitted to CGen's decision;
p.(None): III - issue, in accordance with the resolution of CGen, the acts and decisions within its competence;
p.(None): IV - promote, in accordance with CGen's resolution, the accreditation or disqualification of:
p.(None): a) a national institution that maintains an ex situ collection of samples containing the genetic heritage; and
p.(None): b) national public institution to be responsible for the creation and maintenance of a database dealing with the item listed in items of item IX of § 1
p.(None): of art. 6 of Law No. 13,123, of 2015; and
p.(None): V - implement, maintain and operate the systems:
p.(None): a) traceability of information related to genetic heritage and associated traditional knowledge, provided for in art. 5th; and
p.(None): b) covered by Chapter IV of this Decree.
p.(None): CHAPTER III
p.(None): OF ASSOCIATED TRADITIONAL KNOWLEDGE
p.(None): Art. 12. The right to participation of indigenous populations, traditional communities and traditional farmers who create, develop, own or
p.(None): retain traditional associated knowledge in the decision-making process on issues related to access to associated traditional knowledge and
p.(None): benefit sharing resulting from that access.
p.(None): § 1 Access to associated traditional knowledge of identifiable origin is subject to obtaining prior informed consent.
p.(None): § 2 Access to associated traditional knowledge of non-identifiable origin does not depend on prior informed consent.
p.(None): § 3 Any indigenous population, traditional community or traditional farmer who creates, develops, holds or retains certain knowledge
p.(None): associated traditional is considered an identifiable source of this knowledge, except in the hypothesis of § 3 of art. 9 of Law No. 13,123, of 2015.
p.(None): Art. 13. The indigenous population, traditional community or traditional farmer may deny consent to access their associated traditional knowledge
p.(None): of identifiable origin.
p.(None): Art. 14. The provider of associated traditional knowledge of identifiable origin will choose the form of proof of his prior informed consent,
p.(None): it will freely negotiate its terms and conditions, as well as those of the benefit sharing agreement, including the modality, guaranteeing the right to refuse them.
p.(None): § 1 The parties may establish a deadline for the registration of access to associated traditional knowledge, which is the object of consent, which does not
p.(None): may exceed the time limit set out in § 2 of art. 12 of Law No. 13,123, of 2015.
p.(None): § 2 The federal bodies and entities for the protection of rights, assistance or promotion of the activities of indigenous populations, traditional communities and
p.(None): Traditional farmers should, at the request of the holders, advise on the activities of obtaining prior informed consent and the negotiation of
p.(None): benefit sharing.
p.(None): § 3 For the purposes of the provisions of § 2, federal bodies and entities may request technical support from CGen's Executive Secretariat.
p.(None): Art. 15. Obtaining prior informed consent from an associated traditional knowledge provider must respect traditional forms of organization
p.(None): and representation of the indigenous population, traditional community or traditional farmer and the respective community protocol, if any.
p.(None): Art. 16. The user must observe the following guidelines for obtaining prior informed consent:
p.(None): I - clarifications to the indigenous population, traditional community or traditional farmer about:
p.(None): a) the social, cultural and environmental impacts resulting from the execution of the activity involving access to associated traditional knowledge;
p.(None): b) the rights and responsibilities of each party in carrying out the activity and its results; and
p.(None): c) the right of the indigenous population, traditional community and traditional farmer to refuse access to associated traditional knowledge;
p.(None): II - establishment, together with the indigenous population, traditional community or traditional farmer, of the benefits sharing modalities,
p.(None): monetary or non-monetary, derived from economic exploitation; and
p.(None): III - respect for the right of the indigenous population, traditional community and traditional farmer to refuse access to associated traditional knowledge, during
p.(None): the prior consent process.
p.(None): Art. 17. Subject to the guidelines referred to in art. 16, the instrument of proof of obtaining prior informed consent will be formalized in
p.(None): language accessible to the indigenous population, the traditional community and the traditional farmer and will contain:
p.(None): I - description of the history of the process for obtaining prior informed consent;
p.(None): II - the description of the traditional forms of organization and representation of the indigenous population, traditional community or traditional farmer;
p.(None): III - the objective of the research, as well as its methodology, duration, budget, possible benefits and sources of financing for the project;
p.(None): IV - the intended use of the associated traditional knowledge to be accessed; and
p.(None): V - the geographical area covered by the project and the indigenous populations, traditional communities or traditional farmers involved.
p.(None): Single paragraph. The instrument referred to in the caput must also expressly mention whether the indigenous population, the traditional community or the farmer
p.(None): traditional group received technical or legal advice during the process of obtaining prior informed consent.
p.(None): Art. 18. Access to the genetic heritage of the local or Creole traditional variety or to the locally adapted or Creole breed for agricultural activities comprises
p.(None): access to associated traditional knowledge of non-identifiable origin that gave rise to the variety or race and does not depend on prior consent from the
p.(None): indigenous population, traditional community or traditional farmer who creates, develops, owns or preserves the variety or breed.
p.(None): § 1 Under the terms of item XXIV of art. 2 of Law No. 13,123, of 2015, the activities of production, processing and
p.(None): commercialization of food, beverages, fibers, energy and planted forests.
p.(None): § 2 The biofuels, such as ethanol, biodiesel, biogas and cogeneration of electric energy from
p.(None): biomass processing.
p.(None): § 3 For activities that do not fit the concept of agricultural activity, access to the genetic heritage of a traditional local or Creole variety or to
p.(None): locally adapted or creole breed comprises the associated traditional knowledge that gave rise to the variety or breed, and will follow the rules of access to
p.(None): associated traditional knowledge set out in Law No. 13,123 of 2015 and in this Decree.
p.(None): § 4 In the case of access to the genetic heritage of a traditional local or creole variety referred to in the caput, the user must deposit reproductive material
p.(None): of the variety subject to access in an ex situ collection maintained by a public institution, except when the variety was obtained from the collection itself.
p.(None): Art. 19. Indigenous populations, traditional communities and traditional farmers who create, develop, hold or retain knowledge
p.(None): associated traditional rights are guaranteed to use or freely sell products containing genetic heritage or associated traditional knowledge,
p.(None): subject to the provisions of Law No. 9,456, of April 25, 1997, and Law No. 10,711, of August 5, 2003.
p.(None): Paragraph 1. Anvisa, within the scope of the powers referred to in Law No. 9,782, of January 26, 1999, will regulate the production and sale of products to
p.(None): referred to in the caput.
p.(None): § 2 The regulation provided for in § 1 must establish simplified procedures and will include the participation of indigenous populations, communities
p.(None): traditional farmers and traditional farmers, considering their uses, customs, and traditions.
p.(None): CHAPTER IV
p.(None): NATIONAL GENETIC HERITAGE AND KNOWLEDGE MANAGEMENT SYSTEM
p.(None): TRADITIONAL ASSOCIATE - SISGEN
p.(None): Section I
p.(None): General provisions
p.(None): Art. 20. The National System for the Management of Genetic Heritage and Associated Traditional Knowledge - SisGen is created, an electronic system to be implemented,
p.(None): maintained and operated by the CGen Executive Secretariat for management:
p.(None): I - the register of access to genetic heritage or associated traditional knowledge, as well as the register for sending a sample containing
p.(None): genetic heritage to provide services abroad;
p.(None): II - the record of sending a sample of genetic heritage and the Material Transfer Term;
p.(None): III - authorizations for access to genetic heritage or associated traditional knowledge and remittance abroad, in the cases referred to in art. 13
p.(None): of Law No. 13,123, of 2015;
p.(None): IV - the accreditation of the institutions that maintain the ex situ collections that contain samples of genetic heritage;
p.(None): V - notifications of finished product or reproductive material and benefit sharing agreements; and
p.(None): VI - certificates of regularity of access.
p.(None): § 1 The registration must be carried out in advance:
p.(None): I - the shipment;
p.(None): II - the application for any intellectual property right;
p.(None): III - the commercialization of the intermediate product;
p.(None): IV - the dissemination of results, final or partial, in scientific or communication media; or
p.(None): V - notification of finished product or reproductive material developed as a result of access.
p.(None): § 2 If there are changes in fact or in law in the information provided to SisGen, the user must update his records or noti fi cation,
p.(None): at least once a year.
p.(None): § 3 The update referred to in § 2 must also be carried out to include information regarding the application for any intellectual property right
p.(None): or patent licensing.
p.(None): Art. 21. The information contained in the SisGen is public, except for those that, upon user's request, are considered confidential.
p.(None): Single paragraph. The request referred to in the caput must indicate the relevant legal basis and be accompanied by a non-confidential summary.
p.(None): Section II
p.(None): The register of access to genetic heritage or associated traditional knowledge and the register
p.(None): sending a sample containing genetic heritage to provide services abroad
p.(None): Art. 22. For the registration of access to genetic heritage or associated traditional knowledge, the natural or legal person must
p.(None): complete the electronic SisGen form which will require:
p.(None): I - user identification;
p.(None): II - information on research or technological development activities, including:
p.(None): a) summary of the activity and its respective objectives;
p.(None): b) application sector, in the case of technological development;
p.(None): c) expected or obtained results, depending on the moment of registration;
p.(None): d) responsible team, including partner institutions, if any;
p.(None): e) period of activities;
p.(None): f) identification of genetic heritage at the strictest possible taxonomic level or associated traditional knowledge, as the case may be, in particular:
p.(None): 1. the origin of the genetic heritage, including georeferenced coordinate in the degree, minute and second format, of the place of obtaining in situ, even if
p.(None): have been obtained from ex situ or in silico sources; and
p.(None): 2. of the indigenous population, traditional community or traditional farmer who provide the associated traditional knowledge, even if the knowledge
p.(None): have been obtained from secondary sources;
p.(None): g) declaration if the genetic heritage is a traditional local or creole variety or a locally adapted or creole breed, or if the species is on an official list of
p.(None): endangered species;
p.(None): h) information from the institution based abroad associated with the national institution, in the case provided for in item II of art. 12 of Law No. 13,123, of 2015; and
p.(None): i) identification of partner national institutions, if any;
p.(None): III - previous registration or authorization number, in the case of genetic heritage or associated traditional knowledge accessed from research or
p.(None): technological development carried out after June 30, 2000;
p.(None): IV - proof of obtaining prior informed consent pursuant to art. 9 of Law No. 13,123, of 2015, and of art. 17 of this Decree, when applicable;
p.(None): V - request for recognition of legal secrecy hypothesis; and
p.(None): VI - declaration, as the case may be, of classification in the event of legal exemption or non-incidence of benefit sharing.
p.(None): Paragraph 1 When it is not possible to identify the georeferenced coordinate of the on-site location referred to in item 1 of item “f” of item II of the caput, and
p.(None): only in cases in which the genetic heritage was obtained on a date prior to the entry into force of Law No. 13,123, of 2015, the provenance may be
p.(None): informed based on the most specific geographical location possible, in one of the following ways:
p.(None): I - identification of the source of obtaining ex situ genetic heritage, with the information contained in the deposit record, when it comes from ex collection
p.(None): situ; or
p.(None): II - identification of the genetic heritage source database with the information contained in the deposit record, when it comes from
p.(None): data in silico.
p.(None): § 2 The registration of access to associated traditional knowledge must:
p.(None): I - identify the sources of obtaining the associated traditional knowledge; and
p.(None): II - inform the georeferenced coordinate of the respective community, except when dealing with associated traditional knowledge of non-identifiable origin.
p.(None): Paragraph 3. If it is not possible to inform the georeferenced coordinates referred to in item II of Paragraph 2, the user must inform the geographical location more
p.(None): possible.
p.(None): § 4º CGen will define in technical standard:
p.(None): I - the strictest taxonomic level to be informed, in research cases with the objective of evaluating or elucidating the genetic diversity or the evolutionary history of
p.(None): a taxonomic species or group;
p.(None): II - how to indicate the most specific geographic location possible, in cases where access is exclusively for research purposes in which they are
p.(None): more than one hundred records of origin are required per registration; and
p.(None): III - how to indicate the genetic heritage, in cases of access from samples of substrates containing non-isolated microorganisms.
p.(None): § 5 The user must perform a new registration when there is a change in the genetic heritage or associated traditional knowledge accessed or the objective
p.(None): access.
p.(None): Art. 23. After completing the form referred to in art. 22 SisGen will automatically issue proof of access registration.
p.(None): § 1 The proof of access registration constitutes a suitable document to demonstrate that the user provided the information that was required and produces the
p.(None): following effects:
p.(None): I - allows, under the terms of § 2 of art. 12 of Law No. 13,123, of 2015:
p.(None): a) the application for any property and intellectual rights;
p.(None): b) the commercialization of an intermediate product;
p.(None): c) the dissemination of the results, final or partial, of research or technological development, in scientific or communication media; and
p.(None): d) notification of finished product or reproductive material developed as a result of access; and
p.(None): II - establishes the start of the verification procedure provided for in Section VII of this Chapter.
p.(None): § 2º The user will not need to wait for the verification procedure to finish to carry out the activities referred to in item I of § 1.
p.(None): Art. 24. Sisgen will provide an electronic form in the access register so that the national legal entity, public or private, registers the sending of a sample
p.(None): that contains genetic heritage for the provision of services abroad as part of research or technological development.
p.(None): § 1 The national legal entity, public or private, may authorize the natural person responsible for technological research or development to complete the
p.(None): shipping register.
p.(None): § 2 The registration register referred to in the caput will require:
p.(None): I - information about the recipient institution abroad, including contact information and indication of legal representative; and
p.(None): II - information of the samples to be sent, containing the identification of the genetic heritage to be sent.
p.(None): § 3 The sending of a sample containing genetic heritage for the provision of services abroad, under the terms of item XXX of art. 2 of Law No. 13,123, of
p.(None): 2015, does not result in a transfer of responsibility for the sample of the institution responsible for sending it to the recipient institution.
p.(None): § 4 For the purposes of § 3, the provision of services abroad is the execution of tests or specialized technical activities performed by
p.(None): partner institution of the national institution responsible for access or contracted by it, in return or consideration.
p.(None): Paragraph 5. The consideration or consideration provided for in Paragraph 4 may be waived when the partner institution integrates the research as a co-author, subject to the provisions
p.(None): in § 6.
p.(None): § 6 The legal instrument signed between the national institution responsible for access and the partner or contracted institution must contain:
p.(None): I - identification of genetic heritage at the strictest possible taxonomic level, subject to the provisions of § 4 of art. 22;
p.(None): II - information on:
p.(None): a) the type of sample and the form of packaging; and
p.(None): b) the number of containers, the volume or the weight;
p.(None): III - description of the specialized technical service object of the provision;
p.(None): IV - obligation to return or destroy the samples sent;
p.(None): V - breakdown of the term for the provision of services, detailing by activity to be performed, when applicable; and
p.(None): VI - clauses prohibiting the partner institution or contractor from:
p.(None): a) pass on the sample of the genetic heritage or the information of genetic origin of the species to be sent, including substances from the metabolism
p.(None): these beings to third parties;
p.(None): b) use the sample of genetic heritage or information of genetic origin of the species to be sent for any purpose other than those provided for;
p.(None): c) economically exploit intermediate or finished product or reproductive material resulting from access; and
p.(None): d) request any type of intellectual property right.
p.(None): § 7 The legal instrument referred to in § 6 will not be mandatory in cases of sending a sample for genetic sequencing.
p.(None): § 8 In the case of § 7, the user must formally communicate to the partner or contracted institution the obligations provided for in items IV and VI of § 6.
p.(None): § 9 The registration of sample submission must be carried out within the deadlines defined for the access registration.
p.(None): § 10. The samples to be sent must be accompanied by:
p.(None): I - the legal instrument referred to in § 6; and
p.(None): II - prior informed consent, in case of sending a sample of genetic heritage of a traditional local or creole variety or locally adapted breed
p.(None): or Creole for access in non-agricultural activities, when applicable.
p.(None): Section III
p.(None): From the record of sending a sample of genetic heritage and the Material Transfer Term
p.(None): Art. 25. In order to register the shipment of a sample of genetic heritage, the natural or legal person must complete the form
p.(None): electronic SisGen that will require:
p.(None): I - identification:
p.(None): a) the sender;
p.(None): b) samples of genetic heritage at the strictest possible taxonomic level; and
p.(None): c) the origin of the samples to be sent, observing the provisions of item 1 of item “f” of item II, in § 1 and in item II of § 4 of art. 22;
p.(None): II - information on:
p.(None): a) the type of sample and the form of packaging;
p.(None): b) the number of containers, the volume or the weight;
p.(None): c) the recipient institution abroad, including indication of legal representative and contact information; and
p.(None): d) access activities abroad, including objectives, intended uses and application sector of the research or technological development project;
p.(None): III - Material Transfer Term - TTM, signed between the natural or legal person in Brazil and the legal entity headquartered abroad; and
p.(None): IV - prior informed consent that expressly authorizes the shipment in the case of genetic heritage of a traditional local or creole variety or breed
p.(None): locally adapted or Creole for access in non-agricultural activities, when applicable.
p.(None): § 1 The TTM referred to in item III of the caput must contain:
p.(None): I - the information referred to in items I and II of the caput of this article;
p.(None): II - the obligation to comply with the requirements of Law No. 13,123, of 2015;
p.(None): III - the forecast that:
p.(None): a) the TTM must be interpreted in accordance with Brazilian laws, and, in the event of a dispute, the competent forum is that of Brazil, admitting arbitration agreed between
p.(None): the parts.
p.(None): b) the institution receiving the genetic heritage will not be considered a provider of the genetic heritage; and
p.(None): c) the recipient institution will require a third party to sign a TTM with the obligation to comply with the requirements of Law No. 13,123, 2015, including the
p.(None): provision of line “a” of this item;
p.(None): IV- clause that authorizes or prohibits the transfer of the sample to third parties; and
p.(None): V - information on access to associated traditional knowledge, when applicable.
p.(None): § 2 In the event of authorization referred to in item IV of § 1, the transfer of the sample to third parties will also depend on the signature of the TTM that contains the
p.(None): clauses provided for in § 1.
p.(None): § 3 The provisions of § 2 apply to all subsequent transfers.
p.(None): Art. 26. After completing the form referred to in art. 25 SisGen will automatically issue proof of shipment registration.
p.(None): § 1 The proof of shipment registration constitutes a suitable document to demonstrate that the user provided the information that was required and produces the
p.(None): following effects:
p.(None): I - allows the remittance to take place, under the terms of § 2 of art. 12 of Law No. 13,123, of 2015; and
p.(None): II - establishes the start of the verification procedure provided for in Section VII of this Chapter.
p.(None): § 2 For the purposes of item I of § 1, in addition to the proof of shipment registration, samples must be accompanied by the respective TTM
p.(None): to be sent regularly.
p.(None): § 3 The user will not need to wait for the verification procedure referred to in item II of § 1 to complete before making the shipment.
p.(None): Section IV
p.(None): Authorizations for access to genetic heritage and associated traditional knowledge and
p.(None): remittance abroad, for the cases referred to in art. 13 of Law No. 13,123, of 2015
p.(None): Art. 27. In cases of access to genetic heritage or associated traditional knowledge in areas essential to national security, in waters
p.(None): Brazilian jurisdictions, on the continental shelf and in the exclusive economic zone, access or remittance will be subject to the prior authorization referred to in art. 13 da
p.(None): Law No. 13,123, of 2015, when the user is:
p.(None): I - national legal person, whose controlling shareholders or partners are natural or foreign legal persons;
p.(None): II - national scientific and technological research institution, public or private, when access is made in association with a legal entity based in the
p.(None): outside; or
p.(None): III - Brazilian natural person associated, financed or contracted by a legal entity headquartered abroad.
p.(None): § 1 For the purposes of the caput, the border strip and the oceanic islands are considered essential areas for national security.
p.(None): § 2 The user must, prior to accessing the genetic heritage or associated traditional knowledge, fill in all the information in the
p.(None): access or remittance provided for in arts. 22 and 25, as well as identifying the corporate structure of the company and the associated legal entity, as appropriate.
p.(None): § 3 In the event that the corporate structure is composed of other legal entities, the user must identify the respective corporate structures, until
p.(None): individuals who have the status of partner or controller are identified.
p.(None): § 4 Access and remittance authorizations can be requested together or separately.
p.(None): § 5 The filling in of the access and remittance registration information includes the automatic request for prior authorization and consent by the Council
p.(None): National Defense or Navy Command, as appropriate.
p.(None): § 6 The national institution referred to in item II of the caput that makes several accesses in association with the same foreign legal entity may receive a
p.(None): only authorization for all accesses.
p.(None): § 7 The registration of access and remittance will not be completed until the consent of the National Defense Council or the Navy Command is obtained.
p.(None): Art. 28. After providing the information, SisGen, within five days, will notify the Executive Secretariat of the National Defense Council or the Command of
p.(None): Navy, which must manifest itself within sixty days, considering the national interest.
p.(None): § 1 The request for additional information or documents by the National Defense Council or Navy Command will suspend the term for its
p.(None): manifestation until the effective delivery of what was requested.
p.(None): § 2 The provisions of this Section do not suspend the terms of the administrative verification procedure referred to in Section VII of this Chapter.
p.(None): Art. 29. After obtaining the consent of the National Defense Council or the Navy Command, access or remittance is automatically authorized.
p.(None): § 1 The changes in the corporate structure or in the controlling interest that occurred after obtaining the consent must be informed to SisGen, within thirty
p.(None): days.
p.(None): § 2 The National Defense Council or the Navy Command may, in a reasoned decision, revoke the consent previously granted.
p.(None): § 3 In the hypothesis foreseen in § 2 the user will have a period of thirty days to present his defense.
p.(None): § 4 If the user's arguments are not accepted, the National Defense Council or the Navy Command will revoke the consent and communicate CGen to
p.(None): to cancel the registration of access or remittance.
p.(None): Section V
p.(None): Accreditation of national institutions that maintain collections
p.(None): x situ of samples containing the genetic heritage
p.(None): Art. 30. The accreditation of a national institution that maintains an ex situ collection of samples containing genetic heritage aims to bring together the
p.(None): information necessary for the creation of the database referred to in item “d” of item IX of § 1 of art. 6 of Law No. 13,123, of 2015, in order to guarantee access to
p.(None): strategic information on the ex situ conservation of genetic heritage in the national territory.
p.(None): § 1 In accordance with the provisions of § 2 of art. 32 of Law No. 13,123, of 2015, only the national institution that maintains
p.(None): ex situ collections that are accredited under this Section.
p.(None): § 2 Private non-profit institutions that maintain popular herbaria or community seed banks may be accredited as
p.(None): national institutions that maintain ex situ collections as long as they observe the provisions of this Section.
p.(None): § 3 The criteria for receiving the resources referred to in this article will be defined by the FNRB Management Committee.
p.(None): Art. 31. For the accreditation of a national institution that maintains an ex situ collection of samples containing genetic heritage, the legal entity must
p.(None): fill out an electronic form at SisGen, which will require:
p.(None): I - identification of the institution; and
p.(None): II - information on each of the ex situ collections including:
p.(None): a) identification of curators or guardians;
p.(None): b) types of preserved samples;
p.(None): c) collected taxonomic groups; and
p.(None): d) method of storage and conservation.
p.(None): § 1 Completed the completion of the form by the legal entity, CGen, under the terms of art. 6, § 1, item III, item “b”, of Law No. 13,123, of
p.(None): 2015, will decide on the accreditation referred to in the caput.
p.(None): § 2 The national institution must keep updated the information dealt with in items I and II of the caput.
p.(None): Art. 32. Samples of genetic heritage maintained in ex situ collections in national institutions managed with public resources and the information to them
p.(None): associated areas can be accessed by indigenous peoples, traditional communities and traditional farmers.
p.(None): § 1 The institution that receives the request must, within a period not exceeding twenty days:
p.(None): I - communicate the date, place and method of making the genetic heritage available;
p.(None): II - indicate the reasons for the impossibility, totally or partially, of fulfilling the request; or
p.(None): III - communicate that he does not have the genetic heritage.
p.(None): § 2 The term referred to in § 1 may be extended for another ten days, upon express justification, of which the applicant will be informed.
p.(None): § 3 The amount necessary to reimburse costs for the regeneration or multiplication of samples or availability may be charged exclusively
p.(None): information on genetic heritage.
p.(None): § 4 The provision of a sample must be free of charge when made by national institutions that maintain an ex situ collection that receive funds from the
p.(None): FNRB.
p.(None): Section VI
p.(None): Notifications of finished product or reproductive material and benefit-sharing agreements
p.(None): Art. 33. The user must notify the finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge
p.(None): carried out after the validity of Law No. 13,123, of 2015.
p.(None): § 1 The notification referred to in the caput must be made before the beginning of the economic exploration.
p.(None): § 2 For the purposes of paragraph 1, economic exploration is considered to have started when the first fiscal note for the sale of the finished product is issued or
p.(None): reproductive material.
p.(None): Art. 34. For the notification of the finished product or reproductive material arising from access to genetic heritage or traditional knowledge
p.(None): associated, the user must fill in the electronic form of SisGen, which will require:
p.(None): I - identification of the requesting natural or legal person;
p.(None): II - commercial identification of the finished product or reproductive material and application sector;
p.(None): III - information if the genetic heritage or the associated traditional knowledge used in the finished product is decisive for the formation of the appeal
p.(None): marketing;
p.(None): IV - information on whether the genetic heritage or the associated traditional knowledge used in the finished product is decisive for the existence of
p.(None): functional characteristics;
p.(None): V - forecast of the local, regional, national or international scope of the manufacture and commercialization of the finished product or reproductive material;
p.(None): VI - registration number, or equivalent, of a product or cultivar in a competent organ or entity, such as Anvisa, Ministry of Agriculture, Livestock and
p.(None): Supply and the Brazilian Institute for the Environment and Renewable Natural Resources - Ibama;
p.(None): VII - number of the deposit for requesting intellectual property rights for a product or cultivar at the Ministry of Agriculture, Livestock and Supply or at the INPI,
p.(None): or in offices abroad, if any;
p.(None): VIII - estimated date for the start of commercialization;
p.(None): IX - indication of the type of benefit sharing;
p.(None): X - presentation of a benefit sharing agreement, when applicable;
p.(None): XI - numbers of the records of access to genetic heritage or associated traditional knowledge that gave rise to the finished product or material
p.(None): reproductive system, subject to the provisions of art. 2 and in Chapter VIII of this Decree;
p.(None): XII - numbers of the shipping records that gave rise to the finished product or reproductive material, if any;
p.(None): XIII - request for recognition of legal secrecy hypothesis; and
p.(None): XIV - proof of compliance in the event of legal exemption or non-incidence of benefit sharing.
p.(None): Single paragraph. The benefit-sharing agreement must be submitted:
p.(None): I - at the time of notification, in the case of access to associated traditional knowledge of identifiable origin; or
p.(None): II - within three hundred and sixty-five days from the notification of the finished product or reproductive material.
p.(None): Art. 35. After completing the form referred to in art. 34 SisGen will automatically issue proof of notification.
p.(None): § 1 The proof of notification constitutes a suitable document to demonstrate that the user provided the information that was required and produces the following
p.(None): effects:
p.(None): I - allows the economic exploitation of the finished product or reproductive material, subject to the provisions of art. 16 of Law No. 13,123, of 2015; and
p.(None): II - establishes the start of the verification procedure provided for in Section VII of this Chapter.
p.(None): § 2 The user will not need to wait for the verification procedure referred to in item II of § 1 to finish before starting the economic exploration.
p.(None): Section VII
p.(None): The administrative verification procedure
p.(None): Art. 36. The administrative verification procedure provided for in this Section will be applied in cases of:
p.(None): I - registration of access to genetic heritage or associated traditional knowledge referred to in Section II of this Chapter;
p.(None): II - registration of the shipment of a sample of genetic heritage, referred to in Section III of this Chapter; and
p.(None): III - notification of finished product or reproductive material referred to in Section VI of this Chapter.
p.(None): Art. 37. During the verification period, the CGen Executive Secretariat:
p.(None): I - inform CGen's councilors about the registration or notification;
p.(None): II - forward to the members of the competent sectorial chambers the information related to the species subject to access and the Municipality of its location, according to
p.(None): dissociated form from the respective registers and other information contained therein;
p.(None): III - scientific, under the terms of item X of art. 6 of Law No. 13,123, 2015, federal bodies for the protection of the rights of indigenous populations and communities
p.(None): about registration in the registry for access to associated traditional knowledge; and
p.(None): IV - it will be able to identify, by letter, any irregularities in the registration or notification process, when it will request the ratification of the information
p.(None): or rectify formal errors.
p.(None): § 1 The provisions of the caput must be made by the Executive Secretariat of CGen within the term:
p.(None): I - fifteen days, in relation to items I, II and III; and
p.(None): II - sixty days, in relation to item IV.
p.(None): § 2 CGen's directors will have access to all available information, including those considered confidential, and will not be able to disclose it, under penalty of
p.(None): accountability, under the terms of the legislation.
p.(None): § 3 In cases of manifest fraud, the President of the CGen may cautiously suspend the registrations and the ad referendum notification of the Plenary.
p.(None): § 4 In the event of § 3, the cautionary decision will be forwarded for deliberation at the next plenary session.
p.(None): Art. 38. CGen's directors may identify signs of irregularity in the information contained in the records and the notification within sixty
p.(None): days from the date of the acknowledgment referred to in item I of the caput of art. 37.
p.(None): § 1 The board members may, within the term referred to in the caput, receive subsidies:
p.(None): I - the sectoral chambers;
p.(None): II - the bodies referred to in item III of the caput of art. 37;
p.(None): III - CGen's Executive Secretariat; and
p.(None): IV - directly from holders of associated traditional knowledge or their representatives.
p.(None): Paragraph 2. In the event of the caput, the board member shall submit a request for verification of evidence of irregularity duly justified for the resolution of the
p.(None): CGen plenary session.
p.(None): § 3 In agricultural activities, the fact that the species is domesticated cannot be considered, on its own, as a basis for evidence of irregularity in the register
p.(None): of access to genetic heritage on the grounds of access to associated traditional knowledge.
p.(None): Art. 39. The CGen Plenary will make the admissibility judgment of the application referred to in art. 38 and determine:
p.(None): I - the notification of the user, if he finds the existence of an indication of irregularity; or
p.(None): II - the filing of the application, if there is no evidence of irregularity.
p.(None): § 1 In the case of item I of the caput, the user will have a period of fifteen days to present his manifestation.
p.(None): § 2º No manifestations presented after the period established in § 1 will be received.
p.(None): Art. 40. Once the deadline for presenting the manifestation has expired, the Executive Secretariat will forward the process for deliberation of the CGen Plenary, which
p.(None): you can:
p.(None): I - not accept the merits of the application; or
p.(None): II - comply with the request, when:
p.(None): a) determine that the user retains the access or shipping records, or even the notification, if the irregularity is remedial, under penalty of
p.(None): cancellation of the respective registrations or notification; or
p.(None): b) cancel the access or remittance registrations, or even the notification, if the irregularity is insurmountable, and notify:
p.(None): 1. the bodies and entities referred to in arts. 93 and 109; and
p.(None): 2. the user, to make new registrations or notification.
p.(None): § 1 The following are insurmountable irregularities:
p.(None): I - the existence of associated traditional knowledge of identifiable origin when the registrations or notification indicate only genetic heritage;
p.(None): II - the existence of associated traditional knowledge of identifiable origin, when the registrations or notification indicate only traditional knowledge
p.(None): associate of unidentifiable origin; and
p.(None): III - obtaining prior informed consent in disagreement with the provisions of Law No. 13,123, 2015, and this Decree.
p.(None): § 2 If the finding of the irregularities referred to in items I, II and III of § 1 occurs when the economic exploitation of the product has already started
p.(None): finished or reproductive material, CGen, exceptionally, and as long as no bad faith is set, it may determine that the user retains the
p.(None): notification, and submit, within ninety days, the benefit sharing agreement with the associated traditional knowledge provider.
p.(None): § 3 In the event provided for in § 2, the benefit sharing for the entire corresponding calculation period will be calculated and collected in favor of the
p.(None): beneficiaries and the amounts provided for in the benefit sharing agreement in force on the date of payment.
p.(None): Art. 41. The user may request the issuance of a certificate stating that the respective access and remittance registers as well as the notification:
p.(None): I - applications for verification of evidence of irregularities were not admitted during the verification process; or
p.(None): II - that were subject to a verification request and that this was not accepted.
p.(None): Single paragraph. The certificate referred to in the caput allows the user to be initially warned by the inspection body or entity before receiving
p.(None): any other administrative sanction, if the assessment occurs on facts informed in the respective access and remittance registers as well as the notification.
p.(None): Section VIII
p.(None): The certificate of regularity of access
p.(None): Art. 42. CGen may issue the certificate of regularity of access referred to in item XXII of art. 2 of Law No. 13,123, 2015, upon request from the
p.(None): user.
p.(None): § 1 The certificate provided for in the caput states that the access register has complied with the requirements of Law No. 13,123, of 2015.
p.(None): § 2 n the terms of what determines item IV of § 1 of art. 6 of Law No. 13,123, of 2015, the granting of the certificate of regularity of access will be subject to
p.(None): prior deliberation by CGen, according to procedures to be established in its internal regulations.
p.(None): § 3 Once granted, the certificate of regularity of access:
p.(None): I - declares the regularity of access until the date of its issuance by CGen; and
p.(None): II - prevents the application of administrative sanctions by the competent body or entity specifically in relation to the access activities carried out until the
p.(None): issuing the certificate.
p.(None): § 4 In the situation described in item II of § 3, an error or fraud in the access already attested by CGen has been verified, the inspection body or entity shall adopt
p.(None): administrative measures with CGen to dismantle the certificate previously granted.
p.(None): CHAPTER V
p.(None): BENEFIT BREAKDOWN
p.(None): Section I
p.(None): General provisions
p.(None): Article 43. The benefit sharing referred to in Law No. 13,123, of 2015, will be due as long as there is economic exploitation of:
p.(None): I - finished product arising from access to genetic heritage or associated traditional knowledge carried out after Law No. 13,123, of 2015, or
p.(None): II - reproductive material arising from access to genetic heritage or associated traditional knowledge for the purpose of agricultural activities carried out after the
p.(None): of Law No. 13,123, of 2015.
p.(None): § 1 In the case of the finished product referred to in item I of the caput, the component of genetic heritage or associated traditional knowledge must be one of the
p.(None): main elements of added value.
p.(None): § 2 Under the terms of item XVIII of art. 2 of Law No. 13,123, of 2015, the main elements of added value are the elements whose
p.(None): presence in the finished product is decisive for the existence of functional characteristics or for the formation of market appeal.
p.(None): § 3 For the purposes of this Decree, the following are considered:
p.(None): I - marketing appeal: reference to genetic heritage or associated traditional knowledge, its origin or the differences resulting from it,
p.(None): related to a product, product line or brand, in any visual or auditory media, including marketing campaigns or label prominence
p.(None): of product; and
p.(None): II - functional characteristics: characteristics that determine the main purposes, improve the action of the product or expand its list of purposes.
p.(None): § 4 The use of genetic heritage, exclusively as excipients, will not be considered determinant for the existence of functional characteristics.
p.(None): vehicles or other inert substances, which do not determine functionality.
p.(None): § 5 The substance derived from the metabolism of microorganism will not be considered determinant for the existence of functional characteristics when it is
p.(None): identical to the substance of fossil origin already existing and used instead.
p.(None): § 6 SisGen will provide a specific field in the access register referred to in art. 22 so that the user, if interested, indicates and proves the
p.(None): framing the situation described in § 5.
p.(None): Art. 44. The manufacturer of the finished product or the producer of reproductive material is subject to the sharing of benefits, regardless of
p.(None): who has previously accessed.
p.(None): § 1 In the case of agricultural activity, the sharing of benefits will be due by the producer responsible for the last link in the productive chain of material
p.(None): reproductive.
p.(None): § 2 for the purposes of § 1, the producer responsible for selling reproductive material for production is considered the last link in the production chain,
p.(None): processing and marketing of food, beverages, fibers, energy and planted forests.
p.(None): § 3 In the case of economic exploitation of reproductive material arising from access to genetic heritage or associated traditional knowledge for the purposes of
p.(None): agricultural activities and destined exclusively to the generation of finished products in production chains that do not involve agricultural activity, the
p.(None): benefits will only occur on the economic exploitation of the finished product.
p.(None): Art. 45. The calculation of the net revenue referred to in arts. 20, 21 and 22 of Law No. 13,123, of 2015, will be carried out as determined in § 1 of art. 12 of Decree-Law no.
p.(None): 1,598, of December 26, 1977.
p.(None): § 1 For the purposes of the caput, the manufacturer of the finished product or producer of the reproductive material must declare the annual net revenue for each year
p.(None): tax, obtained with the economic exploitation of each finished product or reproductive material and present a document capable of proving it.
p.(None): § 2 The information provided for in the caput shall be provided to the Ministry of the Environment, in a format defined by him, within ninety days after the
p.(None): end of the fiscal year.
p.(None): § 3 The Ministry of Finance and Ibama will provide the information and technical support necessary to comply with the provisions of this article.
p.(None): § 4 For the purposes of § 3, the Ministry of Finance will observe the provisions of § 2 of art. 198 of Law No. 5,172, of October 25, 1966 - National Tax Code.
p.(None): Art. 46. In the case of finished product or reproductive material produced outside of Brazil, and for the purpose of determining the calculation basis referred to in § 8 of
p.(None): art. 17 of Law No. 13,123, 2015, the Ministry of the Environment may request the manufacturer of the finished product or producer of reproductive material or the
p.(None): joint and several responsible provided for in § 7 of art. 17 of Law No. 13,123, 2015, data and information, duly accompanied by the respective evidence.
p.(None): § 1 The requested data and information must be presented in a format compatible with the systems used by the Ministry of the Environment or in
p.(None): defined by him.
p.(None): § 2 It is the duty of the notified to provide all requested data and information, being responsible for the veracity of its content or for its omission.
p.(None): § 3 The Ministry of Finance will provide the information and technical support necessary to comply with the provisions of the caput.
p.(None): § 4 For the purposes of § 3, the Ministry of Finance will observe the provisions of § 2 of art. 198 of Law No. 5,172, of October 25, 1966 - National Tax Code.
p.(None): Art. 47. The sharing of benefits may consist of monetary and non-monetary modalities.
p.(None): § 1 In the case of economic exploitation of the finished product or reproductive material arising from access to the genetic heritage, the user shall choose
p.(None): one of the modalities of benefit sharing provided for in the caput.
p.(None): § 2 When it comes to the economic exploitation of the finished product or reproductive material arising from access to the traditional knowledge associated with
p.(None): unidentifiable origin, the allocation will be made in monetary form and will be paid to the FNRB.
p.(None): § 3 In the event of economic exploitation of finished product or reproductive material arising from access to associated traditional knowledge of origin
p.(None): identifiable, benefit sharing:
p.(None): I - must be freely negotiated between the user and the indigenous population, the traditional community or the traditional farmer who provides knowledge; and
p.(None): II - the portion owed by the user to the FNRB will correspond to 0.5% (five tenths of percent) of the annual net revenue obtained from the economic exploration or from
p.(None): half of that provided for in a sectoral agreement.
p.(None): Section II
p.(None): Monetary Benefit Sharing
p.(None): Art. 48. The monetary benefit sharing will be destined:
p.(None): I - to indigenous populations, traditional communities and traditional farmers in cases of associated traditional knowledge of identifiable origin,
p.(None): according to an agreement negotiated in a fair and equitable manner between the parties, pursuant to art. 24 of Law No. 13,123, of 2015; and
p.(None): II - to the FNRB, in the case of economic exploitation of the finished product or reproductive material arising from access:
p.(None): a) genetic heritage, in the amount of one percent of the net revenue from the finished product or reproductive material, except in the event of an agreement
p.(None): sector referred to in art. 21 of Law No. 13,123, of 2015;
p.(None): b) associated traditional knowledge of non-identifiable origin, amounting to one percent of the net revenue from the finished product or reproductive material,
p.(None): except in the event of entering into a sectoral agreement referred to in art. 21 of Law No. 13,123, of 2015; and
p.(None): c) associated traditional knowledge of identifiable origin regarding the portion referred to in § 3 of art. 24 of Law No. 13,123, of 2015.
p.(None): Art. 49. The monetary benefit sharing intended for the FNRB will be collected regardless of the benefit sharing agreement and will be calculated after
p.(None): the end of each fiscal year, considering:
p.(None): I - information on the notification of finished product or reproductive material;
p.(None): II - annual net revenue obtained from the economic exploitation of finished product or reproductive material; and
p.(None): III - current sectoral agreement applicable to the finished product or reproductive material.
p.(None): § 1 The amount referring to the sharing of benefits will be collected within 30 days after the information referred to in § 2 of art. 45 as long as there is
p.(None): economical exploitation of the finished product or reproductive material
p.(None): § 2 The first payment of the amount referring to the sharing of benefits must include the benefits earned from the beginning of the economic exploitation until the
p.(None): end of the fiscal year in which there are:
p.(None): I - presentation of the benefit sharing agreement; or
p.(None): II - notification of finished product or reproductive material in cases where the benefit sharing is deposited directly with the FNRB, including exercises
p.(None): previous, if any.
p.(None): Paragraph 3. In the event of a sectoral agreement being concluded, the benefit sharing amount due as of the year of its entry into force will be calculated for the entire period.
p.(None): fiscal year, based on the defined rate.
p.(None): § 4 For the purposes of the provisions of § 8 of art. 17 of Law No. 13,123, of 2015, with no access to information on the product manufacturer's net revenue
p.(None): finished product or reproductive material produced outside of Brazil, the basis for calculating the benefit sharing will be the net revenue of the importer, subsidiary, subsidiary,
p.(None): affiliated, linked or commercial representative of the foreign producer in national territory or abroad.
p.(None): Section III
p.(None): Non-monetary Benefit Sharing
p.(None): Art. 50. The sharing of non-monetary benefits will be made through an agreement signed:
p.(None): I - with indigenous peoples, traditional communities and traditional farmers, providers of associated traditional knowledge of origin
p.(None): identifiable, in cases of economic exploitation of the finished product or reproductive material arising from this knowledge, negotiated in a fair and equitable manner
p.(None): between the parties, under the terms of art. 24 of Law No. 13,123, of 2015; or
p.(None): II - with the Union, in the case of economic exploitation of the finished product or reproductive material arising from access to genetic heritage.
p.(None): § 1 In the benefit sharing agreements implemented through the instruments referred to in items “a”, “e” and “f” of item II of art. 19, of Law nº
p.(None): 13,123, from 2015, the breakdown will be equivalent to seventy-five percent of the forecast for the monetary modality.
p.(None): § 2 In the benefit sharing agreements implemented by means of instruments not provided for in § 1, the allocation will be equivalent to the amount provided for
p.(None): the monetary modality.
p.(None): § 3 The project management expenses, including planning, and accountability, cannot be counted to achieve the percentage provided for in §§
p.(None): 1st and 2nd.
p.(None): § 4 For the purpose of proving the equivalence referred to in §§ 1 and 2, the user must present an estimate, based on market values.
p.(None): § 5 The benefit sharing agreements entered into by the Union will be implemented, preferably, through the instrument referred to in item “a”
p.(None): of item II of art. 19, of Law No. 13,123, of 2015.
p.(None): § 6 The user may not use non-monetary benefit sharing resources in marketing campaigns or any other form of advertising in
p.(None): benefit of your products, product lines or brands.
p.(None): Art. 51. In the case of item II of art. 50, the non-monetary benefit sharing referred to in items “a” and “e” of item II of art. 19 of Law No. 13,123, of
p.(None): 2015, will be aimed at:
p.(None): I - conservation units;
p.(None): II - indigenous lands;
p.(None): III - remaining quilombo territories;
p.(None): IV - rural settlement of family farmers;
p.(None): V - traditional territories under the terms of Decree No. 6,040, of February 7, 2007;
...
p.(None): X - indigenous populations, traditional communities and traditional farmers.
p.(None): Art. 52. In the case of item II of art. 50 the sharing of non-monetary benefits referred to in points “b”, “c”, “d” and “f” of item II of art. 19 of Law nº
p.(None): 13,123, from 2015, will be destined to national public bodies and institutions that execute social interest programs.
p.(None): Art. 53. The Ministry of the Environment may create and maintain the bank of proposals for the sharing of non-monetary benefits, which will be widely publicized,
p.(None): including through its website, to comply with the provisions of item II of art. 19 of Law No. 13,123 of 2015.
p.(None): Single paragraph. The proposals referred to in the caput should be aimed at the conservation and sustainable use of biodiversity, valuing and protecting the
p.(None): associated traditional knowledge, serving the public interest.
p.(None): Section IV
p.(None): Exemptions from benefit sharing
p.(None): Art. 54. Economic exploitation of:
p.(None): I - finished product or reproductive material developed by traditional farmers and their cooperatives, with annual gross revenue equal to or less than the limit
p.(None): maximum established in item II of art. 3 of Complementary Law No. 123, of December 14, 2006;
p.(None): II - finished product or reproductive material developed by micro-enterprises, small businesses and individual micro-entrepreneurs,
p.(None): as provided in Complementary Law No. 123, of 2006;
p.(None): III - operations for licensing, transferring or allowing the use of any form of intellectual property right over the finished product,
p.(None): reproductive process or material arising from access to genetic heritage or traditional knowledge associated by third parties;
p.(None): IV - intermediate products along the production chain;
p.(None): V - reproductive material along the productive chain of reproductive material, except for the economic exploitation carried out by the last link in the productive chain;
p.(None): VI - reproductive material arising from access to genetic heritage or associated traditional knowledge for the purposes of agricultural activities and intended
p.(None): exclusively to the generation of finished products; and
p.(None): VII - finished product or reproductive material arising from access to the genetic heritage of species introduced into the national territory by human action, still
p.(None): domesticated, except for the provisions of items I and II of § 3 of art. 18 of Law No. 13,123, of 2015.
p.(None): § 1 The exchange and dissemination of genetic heritage and associated traditional knowledge are also exempt from the obligation to share benefits.
p.(None): practiced among indigenous peoples, traditional communities or traditional farmers for their own benefit and based on their uses, customs and
p.(None): traditions;
p.(None): § 2 The exemption from the benefit sharing referred to in the caput does not relieve the user from the obligation to notify the finished product or reproductive material as
p.(None): also the fulfillment of the other obligations of Law No. 13,123, of 2015.
p.(None): § 3 The provision in § 2 does not apply to the cases provided for in § 4 of art. 8 of Law No. 13,123, of 2015.
p.(None): § 4 The user who fails to fulfill the exemption requirements provided for in Law No. 13,123, 2015, will share benefits in the following fiscal year.
p.(None): § 5 In the cases provided for in items IV, V and VI of the caput, the user must declare that the product or reproductive material fits as a product
p.(None): intermediate and will only be used for activities and processes along the reproductive chain.
p.(None): Section V
p.(None): The benefit-sharing agreement
p.(None): Art. 55. The benefit sharing agreement between user and provider will be negotiated in a fair and equitable manner between the parties, taking into account
p.(None): clarity, loyalty and transparency in the agreed clauses, which should indicate conditions, obligations, types and duration of short, medium and long term benefits,
p.(None): without prejudice to other guidelines and criteria to be established by CGen.
p.(None): Section VI
p.(None): Sectoral agreements
p.(None): Art. 56. The purpose of sectoral agreements is to guarantee the competitiveness of the productive sector in cases where the application of the 1% (one percent) portion of the
p.(None): annual net revenue obtained from the economic exploitation of the finished product or reproductive material arising from access to genetic heritage or knowledge
p.(None): traditional associate of unidentifiable origin characterizes material damage or threat of material damage.
p.(None): § 1 For the purposes of this Decree, the productive sector is the company or group of companies that produce a certain product or similar feature
p.(None): reduction request.
p.(None): Paragraph 2 In the event provided for in the caput, the percentage of payment of monetary benefit sharing may be reduced to up to 0.1% (one tenth percent)
p.(None): of the annual net revenue obtained from economic exploration.
p.(None): Art. 57. The request to reduce the value of the monetary benefit sharing will be addressed to the Ministry of the Environment and will depend on the demonstration that the
p.(None): payment of that percentage has resulted or will result in material damage.
p.(None): § 1 The confidential information contained in the caption referred to in the caput will be treated as so identified by the interested party, provided that the request is
p.(None): justified, and in this case it cannot be revealed without the express authorization of the interested party.
p.(None): § 2 The interested party that provided confidential information must present a summary to be published, with details that allow its understanding, under penalty of being
p.(None): considered non-confidential.
p.(None): § 3 If the Ministry of the Environment considers the request for confidential treatment unjustified and the interested party refuses to adapt it for annexation in
p.(None): non-confidential records, the information will not be known.
p.(None): Art. 58. The request for reduction of benefit sharing will only be known when the signatory companies hold more than:
p.(None): I - fifty percent of the sectorial production value, in the event that said production is concentrated in up to twenty companies; and
p.(None): II - twenty-five percent of the sectorial production value, in the event that said production is concentrated in more than twenty companies.
p.(None): § 1 For the purposes of this article, the sectorial production value is the estimate of the national production value of the finished product or reproductive material
p.(None): arising from access to genetic heritage or associated traditional knowledge of unidentifiable origin as characterized in the reduction request.
p.(None): § 2 The request must be signed by the legal representatives of each of the signatories and will contain:
p.(None): I - documents proving the causal link between the material damage or its threat and the payment of the monetary benefit sharing corresponding to
p.(None): share of 1% (one percent) of annual net revenue; and
p.(None): II - characterization of the finished product or reproductive material for which the reduction of the 1% (one percent) portion provided for in art. 56.
p.(None): § 3 The characterization indicated in item II of § 2 will include the following information:
p.(None): I - accessed genetic heritage;
p.(None): II - associated traditional knowledge accessed;
p.(None): III - raw materials;
p.(None): IV - chemical composition;
p.(None): V - physical characteristics;
p.(None): VI - standards and technical specifications;
p.(None): VII - production process;
p.(None): VIII - uses and applications;
p.(None): IX - degree of substitutability; and
p.(None): X - distribution channels.
p.(None): § 4 The request will not be known if there is an ongoing verification covering the same or similar products.
p.(None): Art. 59. The conditions of art. 58, the Ministry of Environment:
p.(None): I - publish an act initiating the verification of material damage or its threat; and
p.(None): II - notify:
p.(None): a) interested companies;
p.(None): b) the Ministry of Development, Industry and Foreign Trade; and
p.(None): c) the bodies referred to in the sole paragraph of art. 21 of Law No. 13,123, of 2015.
...
p.(None): thirty months from the beginning of the agreement.
p.(None): § 1 The request referred to in the caput must be accompanied by evidence that the circumstances that justified the application of the rate reduction
p.(None): granted at that time have changed.
p.(None): § 2 The analysis of the request for review will follow the provisions of this Section and consider only the new facts that justified the request.
p.(None): Art. 67. The final decision on the request for review will rest with the Minister of State for the Environment and will be limited to the reduction or not of the rate.
p.(None): Art. 68. If the request for review is accepted, an addendum to the sectoral agreement in force will be formalized.
p.(None): Article 69. The Minister of State for the Environment's act shall establish the complementary rules to the provisions of this Section.
p.(None): CHAPTER VI
p.(None): INFRINGEMENTS AND ADMINISTRATIVE SANCTIONS
p.(None): Section I
p.(None): General provisions
p.(None): Art. 70. An administrative infraction against genetic heritage or associated traditional knowledge is considered as provided in arts. 78 to 91 of this Decree.
p.(None): Art. 71. Without prejudice to the applicable criminal and civil responsibilities, administrative infractions will be punished with the following sanctions:
p.(None): I - warning;
p.(None): II - fine;
p.(None): III - seizure:
p.(None): a) samples containing the genetic heritage accessed;
p.(None): b) the instruments used to obtain or process the genetic heritage or associated traditional knowledge accessed;
p.(None): c) products derived from access to genetic heritage or associated traditional knowledge; or
p.(None): d) products obtained from information on associated traditional knowledge;
p.(None): IV - temporary suspension of the manufacture and sale of the finished product or reproductive material derived from access to genetic heritage or knowledge
p.(None): traditional associated until regularization;
p.(None): V - embargo of the specific activity related to the infraction;
p.(None): VI - partial or total interdiction of the establishment, activity or enterprise;
p.(None): VII - suspension of certificate or authorization; or
p.(None): VIII - cancellation of certificate or authorization.
p.(None): Single paragraph. The sanctions provided for in items I to VIII of the caput may be applied cumulatively.
p.(None): Art. 72. The assessing agent, when drawing up the notice of infraction, shall indicate the sanctions established in this Decree, observing:
p.(None): I - the gravity of the fact;
p.(None): II - the offender's record of compliance with the legislation regarding genetic heritage and associated traditional knowledge;
p.(None): III - recurrence; and
p.(None): IV - the economic situation of the offender, in the case of a fine.
p.(None): Single paragraph. For the application of the provisions of this article, the competent body or entity may establish, by means of a technical standard, criteria
p.(None): complementary measures for the aggravation and mitigation of administrative sanctions.
p.(None): Art. 73. The fine will be arbitrated by the competent authority, for an infraction, and can vary:
p.(None): 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
p.(None): II - from R $ 10,000.00 (ten thousand reais) to 10,000,000.00 (ten million reais), when the infraction is committed by a legal entity, or with its tender.
...
p.(None): administrative infractions against genetic heritage and associated traditional knowledge, counted from the date of practice of the act, or, in the case of permanent infraction or
p.(None): continued, from the day it has ceased.
p.(None): § 1 The investigation of the infraction against the genetic heritage and the traditional knowledge associated with the drawing up of the infraction notice by the
p.(None): competent authority or administrative notification.
p.(None): § 2 The intercurrent prescription applies to the procedure for determining the infraction notice that has been paralyzed for more than three years, pending judgment or order,
p.(None): whose records will be filed by letter or at the request of the interested party, without prejudice to the determination of the functional responsibility arising from the
p.(None): stoppage.
p.(None): Art. 77. The prescription is interrupted:
p.(None): I - for making the offender aware by any means, including by public notice;
p.(None): II - for any unequivocal act of the public administration that requires investigation of the fact; and
p.(None): III - by the appellate condemnatory decision.
p.(None): Single paragraph. An unambiguous act of the public administration is considered, for the purpose of the provision of item II, one that implies instruction of the process.
p.(None): Section III
p.(None): Infractions against genetic heritage and associated traditional knowledge
p.(None): Art. 78. Economically exploiting finished product or reproductive material from access to genetic heritage or associated traditional knowledge without
p.(None): prior notification.
p.(None): Minimum fine of R $ 3,000.00 (three thousand reais) and maximum fine of R $ 30,000.00 (thirty thousand reais), in the case of a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of December 14, 2006.
p.(None): Minimum fine of R $ 30,000.00 (thirty thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): § 1 The sanction provided for in the caput will be applied for finished product or reproductive material, regardless of the number of species accessed for the
p.(None): elaboration of the finished product or reproductive material.
p.(None): § 2 The fine penalty is applied twice if there is commercialization abroad of finished product or reproductive material developed as a result of the
p.(None): access.
p.(None): § 3 The same sanctions foreseen in this article incur those who present a benefit sharing agreement in disagreement with the terms defined in items I
p.(None): and II of § 1 of art. 34.
p.(None): Art. 79. Send, directly or through an intermediary, a sample of genetic heritage abroad without prior registration or in disagreement with it.
p.(None): Minimum fine of R $ 20,000.00 (twenty thousand reais) and maximum of R $ 100,000.00 (one hundred thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 50,000.00 (fifty thousand reais) and maximum of R $ 500,000.00 (five hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 100,000.00 (one hundred thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): § 1 The sanction provided for in the caput will be applied:
p.(None): I - by species;
p.(None): II - in triple if the sample is obtained from species included in official lists of Brazilian species threatened with extinction or from Annex I of the Convention
p.(None): on International Trade in Endangered Species of Wild Flora and Fauna - CITES, promulgated by Decree No. 76,623, of November 17,
p.(None): 1975; and
p.(None): III - twice if the sample is obtained from a species contained only in CITES Appendix II, promulgated by Decree nº 76.623, of 1975.
p.(None): § 2 If the remittance is made for the development of biological or chemical weapons, the penalty provided for in the caput will be quadrupled and must be applied
p.(None): the sanctions of embargo, suspension or partial or total interdiction of the establishment, activity or enterprise, of the person responsible for the consignment.
p.(None): Art. 80. Requesting intellectual property rights resulting from access to genetic heritage or associated traditional knowledge, in Brazil or abroad,
p.(None): without prior registration.
p.(None): Minimum fine of R $ 3,000.00 (three thousand reais) and maximum fine of R $ 30,000.00 (thirty thousand reais), in the case of a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 20,000.00 (twenty thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): Art. 81. Disseminate results, final or partial, in scientific or communication media without prior registration:
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 20,000.00 (twenty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 50,000.00 (fifty thousand reais) and maximum of R $ 500,000.00 (five hundred thousand reais), for other legal entities.
p.(None): § 1 The sanction of a fine may be replaced by a warning, when the circumstances provided for in art. 72.
p.(None): Paragraph 2 The provisions of Paragraph 1 do not apply to cases in which the offense involves access to associated traditional knowledge or when the offender is
p.(None): repeated under this Decree.
p.(None): Art. 82. Failure to register before accessing the marketing of an intermediate product:
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 20,000.00 (twenty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 50,000.00 (fifty thousand reais) and maximum of R $ 500,000.00 (five hundred thousand reais), for other legal entities.
p.(None): § 1 The sanction of a fine may be replaced by a warning, when the circumstances provided for in art. 72.
p.(None): § 2 The provisions of § 1 do not apply to cases in which the offense involves access to associated traditional knowledge or when the offender is
p.(None): repeated under this Decree.
p.(None): Art. 83. Access associated traditional knowledge of identifiable origin without obtaining prior informed consent, or in disagreement with it.
p.(None): Minimum fine of R $ 20,000.00 (twenty thousand reais) and maximum of R $ 100,000.00 (one hundred thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 50,000.00 (fifty thousand reais) and maximum of R $ 500,000.00 (five hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of December 14, 2006.
p.(None): Minimum fine of R $ 100,000.00 (one hundred thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): Single paragraph. The same sanctions apply to those who obtain prior informed consent from the knowledge provider
p.(None): traditional associated under the terms of the Civil Code.
p.(None): Art. 84. Failing to indicate the origin of associated traditional knowledge of identifiable origin in publications, uses, explorations and disclosures of
p.(None): access results.
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 10,000.00 (ten thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of December 14, 2006.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 500,000.00 (five hundred thousand reais), for other legal entities.
p.(None): Art. 85. Failing to pay the annual installment due to the FNRB resulting from the economic exploitation of finished product or developed reproductive material
p.(None): due to access to genetic heritage or associated traditional knowledge.
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 100,000.00 (one hundred thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for legal entities.
p.(None): § 1 The same sanctions apply to anyone who interrupts or partially complies with the agreed benefit sharing, whether monetary or non-monetary.
p.(None): § 2 Observing the limits provided for in the caput, the fine should not be less than 10% (ten percent) nor more than 30% (thirty percent) of the amount annually
p.(None): due.
p.(None): Art. 86. To elaborate or present information, document, study, report or report totally or partially false, or misleading, either in the official systems or in
p.(None): any other administrative procedure related to genetic heritage or associated traditional knowledge:
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 30,000.00 (thirty thousand reais) and maximum of R $ 300,000.00 (three hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 100,000.00 (one hundred thousand reais) and maximum fine of R $ 5,000,000.00 (five million reais), for other legal entities.
...
p.(None): Art. 88. Obstate or hinder the inspection of the obligations provided for in Law nº 13.123, of 2015: Art.
p.(None): Minimum fine of R $ 5,000.00 (five thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 30,000.00 (thirty thousand reais) and maximum fine of R $ 300,000.00 (three hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 100,000.00 (one hundred thousand reais) and maximum fine of R $ 5,000,000.00 (five million reais), for other legal entities.
p.(None): Art. 89. Failing to adapt within the period established in art. 37 of Law No. 13,123, of 2015:
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 10,000.00 (ten thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law 123, of 2006
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 300,000.00 (three hundred thousand reais), for other legal entities.
p.(None): § 1 The sanction provided for in the caput will be applied for finished product or reproductive material or for each access activity, individually, that fails to
p.(None): promote their respective suitability regardless of the number of species accessed.
p.(None): § 2 The sanction of a fine may be replaced by a warning, when the circumstances provided for in art. 72.
p.(None): § 3 In the event of access to genetic heritage or associated traditional knowledge carried out solely for the purposes of scientific research, the sanction of
p.(None): warning about facts related to the respective registration for purposes of adequacy must precede the application of any other administrative sanction.
p.(None): Art. 90. Failing to regularize within the period established in art. 38 of Law No. 13,123, of 2015:
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 10,000.00 (ten thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): § 1 The sanction provided for in the caput will be applied for finished product or reproductive material or for each access activity, individually, that fails to
p.(None): promote their respective regularization regardless of the number of species accessed.
p.(None): § 2 the sanction of a fine may be replaced by a warning, when the circumstances provided for in art. 72, and whether:
p.(None): I - natural person; or
p.(None): II - legal entity that has made access to genetic heritage or associated traditional knowledge solely for the purpose of scientific research.
p.(None): Art. 91. Failure to meet legal or regulatory requirements, when notified by the competent authority within the period granted:
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 30,000.00 (thirty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 15,000.00 (fifteen thousand reais) and maximum fine of R $ 5,000,000.00 (five million reais), for other legal entities.
p.(None): Single paragraph. The fine sanction may be substituted for the warning, when the circumstances provided for in art. 72.
p.(None): Section IV
p.(None): Administrative procedure for investigating violations
p.(None): Art. 92. Infractions against genetic heritage or associated traditional knowledge will be investigated in a specific administrative process through the
p.(None): drawing up of notice of infraction and respective terms, ensuring the right to ample defense and the adversary.
p.(None): Single paragraph. The administrative process referred to in the caput will be governed by the provisions of Decree No. 6,514, of 2008, except when
p.(None): different provision provided for in this Chapter.
p.(None): Article 93. The following are competent to inspect and investigate the administrative infractions provided for in this Decree:
p.(None): I - Ibama;
p.(None): II - the Navy Command, within the scope of Brazilian jurisdictional waters and the continental shelf; and
p.(None): III - the Ministry of Agriculture, Livestock and Supply, within the scope of access to genetic heritage for agricultural activities, under the terms of art.
p.(None): 3 of Law No. 10,883, of June 16, 2004.
p.(None): § 1 When the offense involves associated traditional knowledge, the official bodies that defend the rights of indigenous peoples, communities
p.(None): traditional farmers and traditional farmers will provide support to Ibama's inspection activities.
p.(None): § 2 Joint act of the Ministers of State for the Environment, Agriculture, Livestock and Supply and Defense will regulate the coordinated action of the
p.(None): supervisory bodies.
p.(None): Art. 94. Of the final decision issued by the bodies provided for in art. 93 CGen may appeal within twenty days.
p.(None): Art. 95. CGen act will establish criteria for the destination of the seized samples, products and instruments, referred to in § 4 of art. 27 of Law nº
p.(None): 13,123, 2015.
p.(None): Single paragraph. As long as the act referred to in the caput has not been edited, the competent authority for inspection shall make the destination, observing the provisions
p.(None): in Decree No. 6,514, of 2008.
p.(None): CHAPTER VII
p.(None): THE NATIONAL BENEFIT SHARING FUND AND THE NATIONAL BENEFIT SHARING PROGRAM
p.(None): Art. 96. The National Benefit Sharing Fund - FNRB, established by Law No. 13,123, of 2015, linked to the Ministry of the Environment, is of a nature
p.(None): financial and is intended to support actions and activities aimed at enhancing the genetic heritage and associated traditional knowledge and promoting their use of
p.(None): sustainable way.
p.(None): § 1 The FNRB's revenue comprises:
p.(None): I - appropriations enshrined in the annual budget law and their additional credits;
p.(None): II - donations;
p.(None): III - amounts collected with the payment of administrative fines imposed due to non-compliance with Law No. 13,123, of 2015;
p.(None): IV - external financial resources arising from contracts, agreements or covenants, especially reserved for the Fund's purposes;
p.(None): V - contributions made by users of genetic heritage or associated traditional knowledge to the National Benefit Sharing Program;
p.(None): VI - amounts arising from the sharing of benefits; and
p.(None): VII - other revenues that may be allocated to it.
p.(None): § 2 The monetary resources deposited in the FNRB resulting from the economic exploitation of finished product or reproductive material arising from access to
p.(None): associated traditional knowledge will be used exclusively for actions, activities and projects for the benefit of holders of traditional knowledge
p.(None): associated companies.
p.(None): § 3º The revenues destined to the FNRB and eventual returns of funds will be collected directly to the Fund, according to procedures defined by the Committee
p.(None): Manager.
p.(None): Article 97. The FNRB will be managed by a Management Committee, a collegiate body composed of:
p.(None): I - by a representative and two alternates:
p.(None): a) the Ministry of the Environment, which will preside over it;
p.(None): b) the Ministry of Finance;
p.(None): c) the Ministry of Agriculture, Livestock and Supply;
p.(None): d) from the Ministry of Social Development and Fight against Hunger;
p.(None): e) from the Ministry of Agrarian Development;
p.(None): f) the Ministry of Science, Technology and Innovation;
p.(None): g) the National Indian Foundation - Funai; and
p.(None): h) the Institute of National Historical and Artistic Heritage - Iphan;
p.(None): II - by seven representatives of entities or organizations representing indigenous populations, traditional communities and traditional farmers, being:
p.(None): a) two nominated by the National Council of Traditional Peoples and Communities - CNPCT;
p.(None): b) two nominated by the National Council for Sustainable Rural Development - Condraf;
p.(None): c) two nominated by representatives of indigenous peoples and organizations that are members of the National Council for Indigenous Policy - CNPI; and
p.(None): d) a representative of the indigenous population, traditional community or traditional farmer appointed by the National Council for Food Security and
p.(None): Nutritional - Consea; and
p.(None): III - by a representative of the Brazilian Society for the Progress of Science - SBPC.
p.(None): § 1 The representatives and their alternates will be appointed by the Minister of the Environment, after indication of the respective bodies and entities.
p.(None): § 2 The representatives and alternates will have a two-year term, renewable for an equal period.
p.(None): § 3 In the event of impediments or absences from its president, the Management Committee will be chaired by the alternate representative of the Ministry of the Environment.
p.(None): § 4 The participation in the FNRB Management Committee is considered to be of relevant public interest and will not be remunerated.
p.(None): § 5 To comply with the provisions of item IV of art. 10 of Law No. 13,123, of 2015, the travel and subsistence expenses of the representatives referred to in item II
p.(None): caput will be paid by FNBR.
p.(None): § 6 The Ministry of the Environment may bear the expenses referred to in § 5 in the first two years of operation of the FNBR.
p.(None): § 7 The Management Committee may invite other representatives, without the right to vote, to participate in its meetings.
p.(None): Art. 98. The Management Committee is responsible for:
p.(None): I - decide on the management of the monetary resources deposited in the FNRB, observing the guidelines for the application of the resources established by CGen;
p.(None): II - to define, annually, the percentage of the monetary resources deposited in the FNRB resulting from the economic exploitation of finished product or material
p.(None): reproductive system resulting from access to genetic heritage from ex situ collections, which will be used for the benefit of these collections;
p.(None): III - approve the FNRB Operations Manual, establishing conditions and procedures for the financial execution and the application of resources, including the
p.(None): revenue collection and the hiring, execution, monitoring and evaluation of actions and activities supported by the FNRB;
p.(None): IV - approve the four-year operating plan and review it every two years;
p.(None): V - approve actions, activities and projects to be supported by the FNRB;
p.(None): VI - decide on the hiring of studies and research by the FNRB;
p.(None): VII - approve annual reports of:
p.(None): a) activities and financial execution;
p.(None): b) performance of the financial institution;
p.(None): VIII - establish cooperation instruments, including with States, the Federal District and Municipalities;
p.(None): IX - establish instruments of cooperation and transfer of resources with national public institutions for research, teaching and technical support, including with support
p.(None): financial of FNRB, to follow the actions and activities supported by FNRB; and
p.(None): X - prepare and approve its internal regulations.
p.(None): Single paragraph. The percentage referred to in item II of the caput may not be less than sixty percent or greater than eighty percent.
p.(None): Art. 99. The availability of the FNRB will be maintained in a federal financial institution, which will be responsible for the administration and financial execution of the resources and
p.(None): operationalization of the Fund.
p.(None): Paragraph 1 The depositary fi nancial institution will remunerate the Fund's availabilities, at least, at the average reference rate of the Special Settlement System and of
p.(None): Custody - Selic.
...
p.(None): VI - fostering research and technological development associated with genetic heritage and associated traditional knowledge;
p.(None): VII - survey and inventory of genetic heritage, considering the situation and the degree of variation of existing populations, including those in use
p.(None): potential and, when feasible, assessing any threats to them;
p.(None): VIII - support for the efforts of indigenous populations, traditional communities and traditional farmers in sustainable management and conservation of
p.(None): genetic heritage;
p.(None): IX - conservation of wild plants;
p.(None): X - development of an efficient and sustainable ex situ and in situ conservation system and development and transfer of appropriate technologies for
p.(None): this purpose with a view to improving the sustainable use of genetic heritage;
p.(None): XI - monitoring and maintaining the viability, the degree of variation and the integrity of the genetic heritage maintained by collections;
p.(None): XII - adoption of measures to minimize or, if possible, eliminate threats to genetic heritage;
p.(None): XIII - development and maintenance of the various cultivation systems that favor the sustainable use of genetic heritage;
p.(None): XIV - elaboration and execution of Sustainable Development Plans for Traditional Populations or Communities; and
p.(None): XV - other actions related to access to genetic heritage and associated traditional knowledge, as defined by the FNRB Management Committee.
p.(None): § 1 The FNRB may support projects and training activities for the employees of the bodies and entities referred to in § 2 of art. 14.
p.(None): § 2 The FNRB may support projects and activities related to the elaboration of community protocols.
p.(None): Art. 101. FNRB resources must be used in the PNRB to support actions and activities that promote the objectives provided for in art. 100, through
p.(None): agreements, terms of partnership, collaboration or promotion, agreements, adjustments or other instruments of cooperation and transfer of resources provided for by law.
p.(None): Single paragraph. FNRB resources may also be allocated:
p.(None): I - the analysis, supervision, management and monitoring of supported actions, activities and projects;
p.(None): II - the remuneration and coverage of the expenses of the financial institution related to the administration of the Fund.
p.(None): Art. 102. The Ministry of the Environment will exercise the function of Executive Secretary of the FNRB Management Committee and will provide technical and administrative support
p.(None): necessary for the functioning of the FNRB and implementation of the PNRB.
p.(None): CHAPTER VIII
p.(None): TRANSITIONAL PROVISIONS ON FITNESS AND REGULARIZATION OF ACTIVITIES
p.(None): Art. 103. It shall conform to the terms of Law No. 13,123, of 2015, and of this Decree, within one year, counting from the date of the registration being made available by
p.(None): CGen, the user who performed, as of June 30, 2000, the following activities in accordance with Provisional Measure No. 2,186-16, of August 23, 2001:
p.(None): I - access to genetic heritage or associated traditional knowledge; and
p.(None): II - economic exploitation of finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge.
p.(None): § 1 For the purposes of the caput, the user, observing art. 44 of Law No. 13,123, of 2015, must adopt one or more of the following measures, as
p.(None): the case:
p.(None): I - register access to genetic heritage or associated traditional knowledge;
p.(None): II - notify the finished product or the reproductive material object of economic exploitation, pursuant to Law No. 13,123, of 2015 and this Decree; and
p.(None): III - share the benefits related to the economic exploitation carried out as from the date of entry into force of Law No. 13,123, of 2015, under the terms of Chapter V
p.(None): of said Law and Chapter V of this Decree, except when it was done under Provisional Measure 2,186-16, of 2001.
p.(None): § 2 In the case of item III of § 1, the benefit sharing agreed upon pursuant to Provisional Measure No. 2,186-16, of 2001, will be valid for the term stipulated in the
p.(None): contract for the use of genetic heritage and benefit sharing or the benefit sharing project agreed by CGen.
p.(None): Art. 104. Shall be regularized under the terms of Law No. 13,123, of 2015, and of this Decree, within one year, counting from the date the registry is made available by
p.(None): CGen, the user who, between June 30, 2000 and the date of entry into force of Law No. 13,123, 2015, performed the following activities in disagreement with the
p.(None): legislation in force at the time:
p.(None): I - access to genetic heritage or associated traditional knowledge;
p.(None): II - access and economic exploitation of a product or process arising from access to genetic heritage or associated traditional knowledge, which
p.(None): Provisional Measure No. 2,186-16, of 2001;
p.(None): III - remittance of a sample of genetic heritage abroad; or
p.(None): IV - disclosure, transmission or retransmission of data or information that integrate or constitute associated traditional knowledge.
p.(None): § 1 The regularization referred to in the caput is subject to the signing of the Term of Commitment.
p.(None): § 2 In the event of access to genetic heritage or associated traditional knowledge solely for the purposes of scientific research, the user will be
p.(None): exempted from signing the Term of Commitment, being regularized through registration or authorization of the activity, as the case may be.
p.(None): § 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 2001, and
p.(None): specified in arts. 15 and 20 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 the
p.(None): Law No. 13,123, of 2015.
p.(None): § 4 For the purposes of regularizing the patent applications filed at the INPI during the term of Provisional Measure 2,186-16, of 2001, the applicant must
p.(None): present the proof of registration or authorization referred to in this article.
p.(None): § 5º The user who performed activities in disagreement with Provisional Measure nº 2.186-16, of 2001, even though he obtained authorization during the term of the
p.(None): said Provisional Measure, may, at its discretion, adhere to the regularization process provided for in art. 38 of Law No. 13,123, of 2015.
p.(None): § 6 For the purposes of § 5, the contract for the use of genetic heritage and the sharing of benefits or the project for the sharing of benefits, annulled by the
p.(None): CGen will integrate the commitment term.
p.(None): CHAPTER IX
p.(None): FINAL DISPOSITIONS
p.(None): Art. 105. For the purposes of the provision in item XVII of art. 2 of Law No. 13,123, 2015, the inputs used in agricultural activities are intermediate products.
p.(None): Single paragraph. Inputs for agricultural activities are goods that are consumed in the production activity or that undergo changes, such as
p.(None): wear, damage or loss of physical or chemical properties, depending on the action directly exerted on the product being manufactured, provided they are not
p.(None): included in property, plant and equipment.
p.(None): Art. 106. CGen may create a database for voluntary registration of prior informed consent, granted or denied by the holders of
p.(None): associated traditional knowledge.
p.(None): Art. 107. The following tests, exams and activities, when they are not an integral part of research or technological development, do not configure access to the
p.(None): genetic heritage under the terms of Law No. 13,123, of 2015:
p.(None): I - affiliation or paternity test, sexing technique and karyotype or DNA analysis and other molecular analyzes aimed at the identification of a species
p.(None): or specimen;
p.(None): II - diagnostic tests and clinical examinations for the direct or indirect identification of aetiological agents or hereditary pathologies in an individual;
p.(None): III - extraction, by means of grinding, pressing or bleeding that results in fixed oils;
p.(None): IV - purification of fixed oils that results in a product whose characteristics are identical to those of the original raw material;
p.(None): V - test that aims to assess mortality rates, growth or multiplication of parasites, pathogens, pests and disease vectors;
p.(None): VI - comparison and extraction of information of genetic origin available in national and international databases
p.(None): VI - extracts processing, physical separation, pasteurization, fermentation, pH assessment, total acidity, soluble solids, bacteria and yeast count,
p.(None): molds, faecal coliforms and totals of genetic heritage samples; and
p.(None): VII - physical, chemical and physical-chemical characterization for determining the nutritional information of foods;
p.(None): Single paragraph. It does not configure access to genetic heritage to read or consult information of genetic origin available in databases
p.(None): national and international, even though they are an integral part of technological research and development.
p.(None): Art. 108. The plant or animal genetic improvement carried out by an indigenous population, traditional community or traditional farmer is exempt from registration in the
p.(None): terms of item VI of art. 10 of Law No. 13,123, of 2015.
p.(None): Art. 109. To comply with the provisions of § 2 of art. 12 of Law No. 13,123, of 2015, the user, when requesting intellectual property rights, must
p.(None): inform whether there was access to genetic heritage or associated traditional knowledge, as well as whether there is an access register carried out under the terms of this Decree.
p.(None): Art. 110. If the registration does not exist or in case of its cancellation, Ibama or CGen will communicate the organ and entity provided for in art. 109 for
p.(None): that the applicant for the intellectual property right to present proof of registration in thirty days, under penalty of
p.(None): intellectual property right application.
p.(None): Single paragraph. In the event of no registration, the period of one year referred to in arts. 36, 37 and 38 of Law No. 13,123, of 2015.
p.(None): Art. 111. CGen, with the collaboration of accredited institutions under the terms of item V of art. 15 of Provisional Measure No. 2,186-16, of 2001, will register in the
p.(None): authorizations already issued.
p.(None): Art. 112. Based on the Common Nomenclature of Mercosur - NCM, the List of Classification of Benefit Sharing referred to in § 9 of art.
p.(None): 17 of Law No. 13,123, of 2015, attached to this Decree.
p.(None): Single paragraph. The list referred to in the caput will have an exemplary character and will not exclude the application of the benefit sharing incidence rules
p.(None): provided for in arts. 17 and 18 of Law No. 13,123, of 2015.
p.(None): Art. 113. The Ministry of Agriculture, Livestock and Supply will periodically prepare, publish and review the reference list of animal and plant species
p.(None): domesticated or cultivated that were introduced in the national territory, used in agricultural activities.
...
p.(None): 2011.
p.(None): § 1 The consignment provided for in the caput will be destined exclusively to research and technological development declared in the Material Transfer Term,
p.(None): necessarily linked to the epidemiological situation, and the use of this genetic heritage accessed for other purposes is prohibited.
p.(None): § 2 The benefits resulting from the economic exploitation of the finished product or reproductive material arising from research or technological development that
p.(None): this article deals with will be distributed under the terms of Law No. 13,123, 2015, and this Decree.
p.(None): Art. 116. The Ministry of the Environment, in coordination with the Ministry of Foreign Affairs, may enter into cooperation agreements and agreements with
p.(None): entities in other countries for the purpose of complying with the provisions of Law No. 13,123 of 2015.
p.(None): Art. 117. The provisions of this Decree do not exclude the powers of the Ministry of Science, Technology and Innovation to supervise and control the activities of
p.(None): scientific research in the national territory, when carried out by foreigners, which imply entering the country.
p.(None): Art. 118. The user who requested any intellectual property right, economically exploited the finished product or reproductive material, or disclosed
p.(None): results, final or partial, in scientific or communication media, between November 17, 2015 and the date of availability of the registration, must register the
p.(None): activities referred to in art. 12 of Law No. 13,123, 2015 and notify the finished product or reproductive material developed as a result of access.
p.(None): Paragraph 1 The deadline for registration or notification referred to in the caput will be 1 (one) year, counted from the date the registration is made available by CGen.
p.(None): § 2 Once the registration or notification is made in a timely manner, the user will not be subject to administrative sanction.
p.(None): Art. 119. The following are revoked:
p.(None): I - Decree No. 3,945, of September 28, 2001;
p.(None): II - Decree No. 4,946, of December 31, 2003;
p.(None): III - Decree No. 5,459, of June 7, 2005;
p.(None): IV - Decree No. 6,159, of July 17, 2007; and
p.(None): V - Decree No. 6,915, of July 29, 2009.
p.(None): Art. 120. This Decree comes into force on the date of its publication.
p.(None): Brasília, May 11, 2016; 195th of Independence and 128th of the Republic.
p.(None): DILMA ROUSSEFF
p.(None): Eugênio José Guilherme de Aragão
p.(None): Kátia Abreu
p.(None): Fernando de Magalhães Furlan
p.(None): João Luiz Silva Ferreira
p.(None): Izabella Mônica Vieira Teixeira
p.(None): Patrus Ananias
p.(None): This text does not replace the one published in the DOU of 12.5.2016
p.(None): ATTACHMENT
p.(None): Benefit Sharing Classification List
p.(None): NCM Chapters Section
p.(None): Section I. LIVE ANIMALS AND PRODUCTS Chapters 1 to 5 01.01 to 0508.00.00
p.(None): OF THE ANIMAL KINGDOM
p.(None): Section II. KINGDOM PRODUCTS Chapters 6 to 14 06.01 to 14.04
p.(None): VEGETABLE
p.(None): Section III. FATS AND OILS Chapters 15 15.01 to 15.15
p.(None): ANIMALS OR VEGETABLES; PRODUCTS
p.(None): YOUR
p.(None): DISSOCIATION; FATS
p.(None): PREPARED FOODS;
p.(None): ANIMAL OR WAXES
p.(None): VEGETABLE
p.(None): Section IV. PRODUCTS FROM Chapters 16 to 24 1601.00.00 to 24.03
p.(None): FOOD INDUSTRIES;
p.(None): BEVERAGES, ALCOHOLIC LIQUIDS AND
p.(None): VINEGARS;
p.(None): TOBACCO AND ITS SUCCESSFUL
p.(None): MANUFACTURED
...
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p.(None): systems databases:
p.(None): I - protection and registration of cultivars, seeds and seedlings, agricultural products, establishments and inputs, traffic information
p.(None): international agricultural products and inputs from the Ministry of Agriculture, Livestock and Supply;
p.(None): II - import and export registration under the Integrated Foreign Trade System - Siscomex, instituted by Decree No. 660, of September 25,
p.(None): 1992;
p.(None): III - information on curricula, research groups, institutions registered on the Lattes Platform of the National Council for Scientific Development and
p.(None): Technological - CNPq;
p.(None): IV - information on research and commercial release of genetically modified organisms and derivatives, from the National Technical Commission for
p.(None): Biosafety - CTNBio from the Ministry of Science, Technology and Innovation;
p.(None): V - registration of products from the National Health Surveillance Agency - Anvisa;
p.(None): VI - granting and guaranteeing intellectual property rights of the National Institute of Industrial Property - INPI;
p.(None): VII - national register of social information of the Ministry of Social Development and Fight against Hunger; and
p.(None): VIII - information on cultural heritage of the National Information and Cultural Indicators System - SNIIC, of the Ministry of Culture.
p.(None): § 2 The bodies and entities referred to in this article shall adopt the necessary measures to guarantee access to information through the traceability system and the
p.(None): Ministry of the Environment will adopt the necessary measures for the integration of the information contained in the databases provided for in § 1.
p.(None): § 3 In the impossibility of adopting the measures provided for in § 2, the information must be forwarded to CGen within thirty days, counted from the
p.(None): solicitation.
p.(None): § 4 CGen may also:
p.(None): I - request additional information from the bodies and entities provided for in § 1;
p.(None): II - to request other organs and entities of the federal public administration information that it deems necessary for the traceability of activities
p.(None): arising from access to genetic heritage or associated traditional knowledge; and
p.(None): III - adopt measures to guarantee access to information through the traceability system and the integration of databases with different bodies and entities
p.(None): those provided for in items I to VIII of §1 of the caput.
p.(None): § 5 The bodies and entities of the federal public administration that provide confidential information to CGen shall indicate this circumstance
p.(None): express, specifying, when applicable, the classification of the information regarding the degree and term of confidentiality, in accordance with the provisions of Law No. 12,527, of November 18,
p.(None): 2011, or in specific legislation.
p.(None): § 6 The Executive Secretariat of CGen will ensure the legal confidentiality of information, respecting the classification of information regarding the degree and term of confidentiality,
p.(None): When it's the case.
p.(None): § 7 For the purposes of the caput, CGen may have access to the data contained in systems of the Secretariat of the Federal Revenue of Brazil contained in
p.(None): public domain registration and that do not inform the taxpayers' economic or financial situation.
p.(None): Art. 6 CGen will operate through:
p.(None): I - Plenary;
p.(None): II - Thematic Chambers;
p.(None): III - Sectorial Chambers; and
p.(None): IV - Executive Secretariat.
p.(None): Section II
p.(None): From the Plenary
p.(None): Article 7. The CGen Plenary will be composed of twenty-one members, twelve representatives of federal public administration bodies and nine
p.(None): representatives of civil society, distributed as follows:
p.(None): I - one representative from each of the following ministries:
p.(None): a) Ministry of the Environment;
p.(None): b) Ministry of Justice;
p.(None): c) Ministry of Health;
p.(None): d) Ministry of Foreign Affairs;
p.(None): e) Ministry of Agriculture, Livestock and Supply;
...
p.(None): except in the event of entering into a sectoral agreement referred to in art. 21 of Law No. 13,123, of 2015; and
p.(None): c) associated traditional knowledge of identifiable origin regarding the portion referred to in § 3 of art. 24 of Law No. 13,123, of 2015.
p.(None): Art. 49. The monetary benefit sharing intended for the FNRB will be collected regardless of the benefit sharing agreement and will be calculated after
p.(None): the end of each fiscal year, considering:
p.(None): I - information on the notification of finished product or reproductive material;
p.(None): II - annual net revenue obtained from the economic exploitation of finished product or reproductive material; and
p.(None): III - current sectoral agreement applicable to the finished product or reproductive material.
p.(None): § 1 The amount referring to the sharing of benefits will be collected within 30 days after the information referred to in § 2 of art. 45 as long as there is
p.(None): economical exploitation of the finished product or reproductive material
p.(None): § 2 The first payment of the amount referring to the sharing of benefits must include the benefits earned from the beginning of the economic exploitation until the
p.(None): end of the fiscal year in which there are:
p.(None): I - presentation of the benefit sharing agreement; or
p.(None): II - notification of finished product or reproductive material in cases where the benefit sharing is deposited directly with the FNRB, including exercises
p.(None): previous, if any.
p.(None): Paragraph 3. In the event of a sectoral agreement being concluded, the benefit sharing amount due as of the year of its entry into force will be calculated for the entire period.
p.(None): fiscal year, based on the defined rate.
p.(None): § 4 For the purposes of the provisions of § 8 of art. 17 of Law No. 13,123, of 2015, with no access to information on the product manufacturer's net revenue
p.(None): finished product or reproductive material produced outside of Brazil, the basis for calculating the benefit sharing will be the net revenue of the importer, subsidiary, subsidiary,
p.(None): affiliated, linked or commercial representative of the foreign producer in national territory or abroad.
p.(None): Section III
p.(None): Non-monetary Benefit Sharing
p.(None): Art. 50. The sharing of non-monetary benefits will be made through an agreement signed:
p.(None): I - with indigenous peoples, traditional communities and traditional farmers, providers of associated traditional knowledge of origin
p.(None): identifiable, in cases of economic exploitation of the finished product or reproductive material arising from this knowledge, negotiated in a fair and equitable manner
p.(None): between the parties, under the terms of art. 24 of Law No. 13,123, of 2015; or
p.(None): II - with the Union, in the case of economic exploitation of the finished product or reproductive material arising from access to genetic heritage.
p.(None): § 1 In the benefit sharing agreements implemented through the instruments referred to in items “a”, “e” and “f” of item II of art. 19, of Law nº
p.(None): 13,123, from 2015, the breakdown will be equivalent to seventy-five percent of the forecast for the monetary modality.
p.(None): § 2 In the benefit sharing agreements implemented by means of instruments not provided for in § 1, the allocation will be equivalent to the amount provided for
p.(None): the monetary modality.
p.(None): § 3 The project management expenses, including planning, and accountability, cannot be counted to achieve the percentage provided for in §§
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Social / Marital Status
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p.(None): a) records of access to genetic heritage or associated traditional and referral knowledge;
p.(None): b) authorizations for access to genetic heritage or associated traditional and referral knowledge;
p.(None): c) instruments and material transfer terms for sending samples and shipments;
p.(None): d) the ex situ collections of accredited institutions that contain samples of genetic heritage;
p.(None): e) notifications of finished product or reproductive material;
p.(None): f) benefit sharing agreements; and
p.(None): g) certificates of regularity of access;
p.(None): XI - scienti fi c federal agencies to protect the rights of indigenous populations, traditional communities and traditional farmers on registration in
p.(None): registration of access to associated traditional knowledge; and
p.(None): XII - approve its internal regulations, which shall provide, at least, about:
p.(None): a) organization and functioning of its meetings;
p.(None): b) functioning of the Executive Secretariat;
p.(None): c) procedure for the appointment of its Directors;
p.(None): d) removal, impediment, suspicion and hypotheses of conflict of interests of the Directors;
p.(None): e) publicizing its technical standards and resolutions; and
p.(None): f) composition and functioning of the Thematic and Sectorial Chambers.
p.(None): Single paragraph. CGen may, at the user's request, issue an internationally recognized certificate of compliance that will serve as proof that
p.(None): activities on genetic heritage or associated traditional knowledge were carried out in accordance with Law No. 13,123 of 2015 and this Decree.
p.(None): Art. 5 Without prejudice to the System provided for in Chapter IV of this Decree, CGen shall maintain its own system for traceability of activities resulting from
p.(None): access to genetic heritage or associated traditional knowledge, including those related to economic exploitation.
p.(None): § 1 Under the terms of art. 7 of Law No. 13,123 of 2015, the system provided for in the caput will be managed by the Executive Secretariat of CGen and will have the
p.(None): information necessary for the traceability of activities resulting from access to genetic heritage or associated traditional knowledge
p.(None): systems databases:
p.(None): I - protection and registration of cultivars, seeds and seedlings, agricultural products, establishments and inputs, traffic information
p.(None): international agricultural products and inputs from the Ministry of Agriculture, Livestock and Supply;
p.(None): II - import and export registration under the Integrated Foreign Trade System - Siscomex, instituted by Decree No. 660, of September 25,
p.(None): 1992;
p.(None): III - information on curricula, research groups, institutions registered on the Lattes Platform of the National Council for Scientific Development and
p.(None): Technological - CNPq;
...
p.(None): representatives of civil society defray the travel and subsistence expenses of their respective representatives.
p.(None): § 6 The Union will be responsible for defraying the travel and subsistence expenses of the members referred to in item IV of the caput.
p.(None): Section III
p.(None): Thematic Chambers and Sectorial Chambers
p.(None): Art. 8 Thematic Chambers will be created by CGen to support the decisions of the Plenary based on technical discussions and presentation of proposals on
p.(None): specific themes or areas of knowledge related to access and benefit sharing.
p.(None): § 1 The act of creating the Thematic Chambers will provide for their attributions, duration and composition, which must observe the proportion of:
p.(None): I - fifty percent of representatives of federal public administration bodies and entities with competences related to the subject of the respective Chamber;
p.(None): II - twenty-five percent of organizations representing the user sector; and
p.(None): III - twenty-five percent of organizations representing associated traditional knowledge providers.
p.(None): § 2 The CGen may create a special Thematic Chamber to analyze and support the Plenary's judgment of appeals filed as a last resort.
p.(None): Art. 9 The Sectorial Chambers will be created by CGen to support the decisions of the Plenary based on technical discussions and presentation of proposals for
p.(None): interest of the business and academic sectors, as well as of indigenous populations, traditional communities and traditional farmers.
p.(None): Single paragraph. The act of creation of the Sectorial Chambers will provide for their attributions, duration and composition, which must observe parity between
p.(None): representation of federal public administration bodies and entities with competences related to the respective Chamber and the civil society sector
p.(None): corresponding.
p.(None): Art. 10. The members of the Thematic Chambers and the Sectorial Chambers will be appointed by the members of the Plenary of CGen, considering the formation, the
p.(None): performance or notorious knowledge in the area related to the Chamber's competences.
p.(None): Section IV
p.(None): The Executive Secretariat
p.(None): Art. 11. The Executive Secretariat of CGen is responsible for:
p.(None): I - provide technical and administrative support to the Plenary of CGen and its Chambers;
p.(None): II - promote the instruction and processing of the processes to be submitted to CGen's decision;
p.(None): III - issue, in accordance with the resolution of CGen, the acts and decisions within its competence;
p.(None): IV - promote, in accordance with CGen's resolution, the accreditation or disqualification of:
p.(None): a) a national institution that maintains an ex situ collection of samples containing the genetic heritage; and
p.(None): b) national public institution to be responsible for the creation and maintenance of a database dealing with the item listed in items of item IX of § 1
p.(None): of art. 6 of Law No. 13,123, of 2015; and
p.(None): V - implement, maintain and operate the systems:
p.(None): a) traceability of information related to genetic heritage and associated traditional knowledge, provided for in art. 5th; and
p.(None): b) covered by Chapter IV of this Decree.
p.(None): CHAPTER III
p.(None): OF ASSOCIATED TRADITIONAL KNOWLEDGE
...
p.(None): II - establishment, together with the indigenous population, traditional community or traditional farmer, of the benefits sharing modalities,
p.(None): monetary or non-monetary, derived from economic exploitation; and
p.(None): III - respect for the right of the indigenous population, traditional community and traditional farmer to refuse access to associated traditional knowledge, during
p.(None): the prior consent process.
p.(None): Art. 17. Subject to the guidelines referred to in art. 16, the instrument of proof of obtaining prior informed consent will be formalized in
p.(None): language accessible to the indigenous population, the traditional community and the traditional farmer and will contain:
p.(None): I - description of the history of the process for obtaining prior informed consent;
p.(None): II - the description of the traditional forms of organization and representation of the indigenous population, traditional community or traditional farmer;
p.(None): III - the objective of the research, as well as its methodology, duration, budget, possible benefits and sources of financing for the project;
p.(None): IV - the intended use of the associated traditional knowledge to be accessed; and
p.(None): V - the geographical area covered by the project and the indigenous populations, traditional communities or traditional farmers involved.
p.(None): Single paragraph. The instrument referred to in the caput must also expressly mention whether the indigenous population, the traditional community or the farmer
p.(None): traditional group received technical or legal advice during the process of obtaining prior informed consent.
p.(None): Art. 18. Access to the genetic heritage of the local or Creole traditional variety or to the locally adapted or Creole breed for agricultural activities comprises
p.(None): access to associated traditional knowledge of non-identifiable origin that gave rise to the variety or race and does not depend on prior consent from the
p.(None): indigenous population, traditional community or traditional farmer who creates, develops, owns or preserves the variety or breed.
p.(None): § 1 Under the terms of item XXIV of art. 2 of Law No. 13,123, of 2015, the activities of production, processing and
p.(None): commercialization of food, beverages, fibers, energy and planted forests.
p.(None): § 2 The biofuels, such as ethanol, biodiesel, biogas and cogeneration of electric energy from
p.(None): biomass processing.
p.(None): § 3 For activities that do not fit the concept of agricultural activity, access to the genetic heritage of a traditional local or Creole variety or to
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p.(None): III - authorizations for access to genetic heritage or associated traditional knowledge and remittance abroad, in the cases referred to in art. 13
p.(None): of Law No. 13,123, of 2015;
p.(None): IV - the accreditation of the institutions that maintain the ex situ collections that contain samples of genetic heritage;
p.(None): V - notifications of finished product or reproductive material and benefit sharing agreements; and
p.(None): VI - certificates of regularity of access.
p.(None): § 1 The registration must be carried out in advance:
p.(None): I - the shipment;
p.(None): II - the application for any intellectual property right;
p.(None): III - the commercialization of the intermediate product;
p.(None): IV - the dissemination of results, final or partial, in scientific or communication media; or
p.(None): V - notification of finished product or reproductive material developed as a result of access.
p.(None): § 2 If there are changes in fact or in law in the information provided to SisGen, the user must update his records or noti fi cation,
p.(None): at least once a year.
p.(None): § 3 The update referred to in § 2 must also be carried out to include information regarding the application for any intellectual property right
p.(None): or patent licensing.
p.(None): Art. 21. The information contained in the SisGen is public, except for those that, upon user's request, are considered confidential.
p.(None): Single paragraph. The request referred to in the caput must indicate the relevant legal basis and be accompanied by a non-confidential summary.
p.(None): Section II
p.(None): The register of access to genetic heritage or associated traditional knowledge and the register
p.(None): sending a sample containing genetic heritage to provide services abroad
p.(None): Art. 22. For the registration of access to genetic heritage or associated traditional knowledge, the natural or legal person must
p.(None): complete the electronic SisGen form which will require:
p.(None): I - user identification;
p.(None): II - information on research or technological development activities, including:
p.(None): a) summary of the activity and its respective objectives;
p.(None): b) application sector, in the case of technological development;
p.(None): c) expected or obtained results, depending on the moment of registration;
p.(None): d) responsible team, including partner institutions, if any;
p.(None): e) period of activities;
p.(None): f) identification of genetic heritage at the strictest possible taxonomic level or associated traditional knowledge, as the case may be, in particular:
p.(None): 1. the origin of the genetic heritage, including georeferenced coordinate in the degree, minute and second format, of the place of obtaining in situ, even if
p.(None): have been obtained from ex situ or in silico sources; and
...
p.(None): marketing;
p.(None): IV - information on whether the genetic heritage or the associated traditional knowledge used in the finished product is decisive for the existence of
p.(None): functional characteristics;
p.(None): V - forecast of the local, regional, national or international scope of the manufacture and commercialization of the finished product or reproductive material;
p.(None): VI - registration number, or equivalent, of a product or cultivar in a competent organ or entity, such as Anvisa, Ministry of Agriculture, Livestock and
p.(None): Supply and the Brazilian Institute for the Environment and Renewable Natural Resources - Ibama;
p.(None): VII - number of the deposit for requesting intellectual property rights for a product or cultivar at the Ministry of Agriculture, Livestock and Supply or at the INPI,
p.(None): or in offices abroad, if any;
p.(None): VIII - estimated date for the start of commercialization;
p.(None): IX - indication of the type of benefit sharing;
p.(None): X - presentation of a benefit sharing agreement, when applicable;
p.(None): XI - numbers of the records of access to genetic heritage or associated traditional knowledge that gave rise to the finished product or material
p.(None): reproductive system, subject to the provisions of art. 2 and in Chapter VIII of this Decree;
p.(None): XII - numbers of the shipping records that gave rise to the finished product or reproductive material, if any;
p.(None): XIII - request for recognition of legal secrecy hypothesis; and
p.(None): XIV - proof of compliance in the event of legal exemption or non-incidence of benefit sharing.
p.(None): Single paragraph. The benefit-sharing agreement must be submitted:
p.(None): I - at the time of notification, in the case of access to associated traditional knowledge of identifiable origin; or
p.(None): II - within three hundred and sixty-five days from the notification of the finished product or reproductive material.
p.(None): Art. 35. After completing the form referred to in art. 34 SisGen will automatically issue proof of notification.
p.(None): § 1 The proof of notification constitutes a suitable document to demonstrate that the user provided the information that was required and produces the following
p.(None): effects:
p.(None): I - allows the economic exploitation of the finished product or reproductive material, subject to the provisions of art. 16 of Law No. 13,123, of 2015; and
p.(None): II - establishes the start of the verification procedure provided for in Section VII of this Chapter.
p.(None): § 2 The user will not need to wait for the verification procedure referred to in item II of § 1 to finish before starting the economic exploration.
p.(None): Section VII
p.(None): The administrative verification procedure
p.(None): Art. 36. The administrative verification procedure provided for in this Section will be applied in cases of:
p.(None): I - registration of access to genetic heritage or associated traditional knowledge referred to in Section II of this Chapter;
p.(None): II - registration of the shipment of a sample of genetic heritage, referred to in Section III of this Chapter; and
p.(None): III - notification of finished product or reproductive material referred to in Section VI of this Chapter.
p.(None): Art. 37. During the verification period, the CGen Executive Secretariat:
...
p.(None): I - the existence of associated traditional knowledge of identifiable origin when the registrations or notification indicate only genetic heritage;
p.(None): II - the existence of associated traditional knowledge of identifiable origin, when the registrations or notification indicate only traditional knowledge
p.(None): associate of unidentifiable origin; and
p.(None): III - obtaining prior informed consent in disagreement with the provisions of Law No. 13,123, 2015, and this Decree.
p.(None): § 2 If the finding of the irregularities referred to in items I, II and III of § 1 occurs when the economic exploitation of the product has already started
p.(None): finished or reproductive material, CGen, exceptionally, and as long as no bad faith is set, it may determine that the user retains the
p.(None): notification, and submit, within ninety days, the benefit sharing agreement with the associated traditional knowledge provider.
p.(None): § 3 In the event provided for in § 2, the benefit sharing for the entire corresponding calculation period will be calculated and collected in favor of the
p.(None): beneficiaries and the amounts provided for in the benefit sharing agreement in force on the date of payment.
p.(None): Art. 41. The user may request the issuance of a certificate stating that the respective access and remittance registers as well as the notification:
p.(None): I - applications for verification of evidence of irregularities were not admitted during the verification process; or
p.(None): II - that were subject to a verification request and that this was not accepted.
p.(None): Single paragraph. The certificate referred to in the caput allows the user to be initially warned by the inspection body or entity before receiving
p.(None): any other administrative sanction, if the assessment occurs on facts informed in the respective access and remittance registers as well as the notification.
p.(None): Section VIII
p.(None): The certificate of regularity of access
p.(None): Art. 42. CGen may issue the certificate of regularity of access referred to in item XXII of art. 2 of Law No. 13,123, 2015, upon request from the
p.(None): user.
p.(None): § 1 The certificate provided for in the caput states that the access register has complied with the requirements of Law No. 13,123, of 2015.
p.(None): § 2 n the terms of what determines item IV of § 1 of art. 6 of Law No. 13,123, of 2015, the granting of the certificate of regularity of access will be subject to
p.(None): prior deliberation by CGen, according to procedures to be established in its internal regulations.
p.(None): § 3 Once granted, the certificate of regularity of access:
p.(None): I - declares the regularity of access until the date of its issuance by CGen; and
p.(None): II - prevents the application of administrative sanctions by the competent body or entity specifically in relation to the access activities carried out until the
p.(None): issuing the certificate.
...
p.(None): benefit of your products, product lines or brands.
p.(None): Art. 51. In the case of item II of art. 50, the non-monetary benefit sharing referred to in items “a” and “e” of item II of art. 19 of Law No. 13,123, of
p.(None): 2015, will be aimed at:
p.(None): I - conservation units;
p.(None): II - indigenous lands;
p.(None): III - remaining quilombo territories;
p.(None): IV - rural settlement of family farmers;
p.(None): V - traditional territories under the terms of Decree No. 6,040, of February 7, 2007;
p.(None): VI - national public research and development institutions;
p.(None): VII - priority areas for conservation, sustainable use and benefit sharing of Brazilian biodiversity, as per the act of the Minister of State of
p.(None): Environment;
p.(None): VIII - activities related to the safeguarding of associated traditional knowledge;
p.(None): IX - ex situ collections maintained by accredited institutions under the terms of Chapter IV, Section V; and
p.(None): X - indigenous populations, traditional communities and traditional farmers.
p.(None): Art. 52. In the case of item II of art. 50 the sharing of non-monetary benefits referred to in points “b”, “c”, “d” and “f” of item II of art. 19 of Law nº
p.(None): 13,123, from 2015, will be destined to national public bodies and institutions that execute social interest programs.
p.(None): Art. 53. The Ministry of the Environment may create and maintain the bank of proposals for the sharing of non-monetary benefits, which will be widely publicized,
p.(None): including through its website, to comply with the provisions of item II of art. 19 of Law No. 13,123 of 2015.
p.(None): Single paragraph. The proposals referred to in the caput should be aimed at the conservation and sustainable use of biodiversity, valuing and protecting the
p.(None): associated traditional knowledge, serving the public interest.
p.(None): Section IV
p.(None): Exemptions from benefit sharing
p.(None): Art. 54. Economic exploitation of:
p.(None): I - finished product or reproductive material developed by traditional farmers and their cooperatives, with annual gross revenue equal to or less than the limit
p.(None): maximum established in item II of art. 3 of Complementary Law No. 123, of December 14, 2006;
p.(None): II - finished product or reproductive material developed by micro-enterprises, small businesses and individual micro-entrepreneurs,
p.(None): as provided in Complementary Law No. 123, of 2006;
p.(None): III - operations for licensing, transferring or allowing the use of any form of intellectual property right over the finished product,
p.(None): reproductive process or material arising from access to genetic heritage or traditional knowledge associated by third parties;
p.(None): IV - intermediate products along the production chain;
p.(None): V - reproductive material along the productive chain of reproductive material, except for the economic exploitation carried out by the last link in the productive chain;
p.(None): VI - reproductive material arising from access to genetic heritage or associated traditional knowledge for the purposes of agricultural activities and intended
p.(None): exclusively to the generation of finished products; and
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p.(None): CHAPTER VI
p.(None): INFRINGEMENTS AND ADMINISTRATIVE SANCTIONS
p.(None): Section I
p.(None): General provisions
p.(None): Art. 70. An administrative infraction against genetic heritage or associated traditional knowledge is considered as provided in arts. 78 to 91 of this Decree.
p.(None): Art. 71. Without prejudice to the applicable criminal and civil responsibilities, administrative infractions will be punished with the following sanctions:
p.(None): I - warning;
p.(None): II - fine;
p.(None): III - seizure:
p.(None): a) samples containing the genetic heritage accessed;
p.(None): b) the instruments used to obtain or process the genetic heritage or associated traditional knowledge accessed;
p.(None): c) products derived from access to genetic heritage or associated traditional knowledge; or
p.(None): d) products obtained from information on associated traditional knowledge;
p.(None): IV - temporary suspension of the manufacture and sale of the finished product or reproductive material derived from access to genetic heritage or knowledge
p.(None): traditional associated until regularization;
p.(None): V - embargo of the specific activity related to the infraction;
p.(None): VI - partial or total interdiction of the establishment, activity or enterprise;
p.(None): VII - suspension of certificate or authorization; or
p.(None): VIII - cancellation of certificate or authorization.
p.(None): Single paragraph. The sanctions provided for in items I to VIII of the caput may be applied cumulatively.
p.(None): Art. 72. The assessing agent, when drawing up the notice of infraction, shall indicate the sanctions established in this Decree, observing:
p.(None): I - the gravity of the fact;
p.(None): II - the offender's record of compliance with the legislation regarding genetic heritage and associated traditional knowledge;
p.(None): III - recurrence; and
p.(None): IV - the economic situation of the offender, in the case of a fine.
p.(None): Single paragraph. For the application of the provisions of this article, the competent body or entity may establish, by means of a technical standard, criteria
p.(None): complementary measures for the aggravation and mitigation of administrative sanctions.
p.(None): Art. 73. The fine will be arbitrated by the competent authority, for an infraction, and can vary:
p.(None): 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
p.(None): II - from R $ 10,000.00 (ten thousand reais) to 10,000,000.00 (ten million reais), when the infraction is committed by a legal entity, or with its tender.
p.(None): Art. 74. The committing of a new infraction by the same infringer, in the period of five years, counted from the final and unappealable decision of the administrative decision that has
p.(None): convicted of a previous offense, implies:
p.(None): I - application of the fine in triple, in case of committing the same infraction; or
p.(None): II - application of a double fine, in the case of a distinct offense.
p.(None): § 1 The aggravation will be determined in the procedure of the new infraction, which will include, by copy, the previous infraction notice and the judgment that the
p.(None): confirmed.
p.(None): § 2 Before the judgment of the new infraction, the environmental authority shall verify the existence of a previous infraction notice confirmed in judgment, for the purposes of
p.(None): application of the aggravation of the new penalty.
p.(None): Paragraph 3. The existence of an infraction notice previously confirmed in judgment, the environmental authority shall:
p.(None): I - aggravate the penalty as provided in the caput;
...
p.(None): III - judge the new infraction considering the increase in the penalty.
p.(None): Art. 75. For the sanctions provided for in items III to VI of art. 71, the provisions of Decree No. 6,514, of July 22, 2008, apply as appropriate.
p.(None): Section II
p.(None): Limitation periods
p.(None): Art. 76. Under the terms of Law No. 9,873, of November 23, 1999, the public administration prescribes the action of five years in order to investigate the practice of
p.(None): administrative infractions against genetic heritage and associated traditional knowledge, counted from the date of practice of the act, or, in the case of permanent infraction or
p.(None): continued, from the day it has ceased.
p.(None): § 1 The investigation of the infraction against the genetic heritage and the traditional knowledge associated with the drawing up of the infraction notice by the
p.(None): competent authority or administrative notification.
p.(None): § 2 The intercurrent prescription applies to the procedure for determining the infraction notice that has been paralyzed for more than three years, pending judgment or order,
p.(None): whose records will be filed by letter or at the request of the interested party, without prejudice to the determination of the functional responsibility arising from the
p.(None): stoppage.
p.(None): Art. 77. The prescription is interrupted:
p.(None): I - for making the offender aware by any means, including by public notice;
p.(None): II - for any unequivocal act of the public administration that requires investigation of the fact; and
p.(None): III - by the appellate condemnatory decision.
p.(None): Single paragraph. An unambiguous act of the public administration is considered, for the purpose of the provision of item II, one that implies instruction of the process.
p.(None): Section III
p.(None): Infractions against genetic heritage and associated traditional knowledge
p.(None): Art. 78. Economically exploiting finished product or reproductive material from access to genetic heritage or associated traditional knowledge without
p.(None): prior notification.
p.(None): Minimum fine of R $ 3,000.00 (three thousand reais) and maximum fine of R $ 30,000.00 (thirty thousand reais), in the case of a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of December 14, 2006.
p.(None): Minimum fine of R $ 30,000.00 (thirty thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): § 1 The sanction provided for in the caput will be applied for finished product or reproductive material, regardless of the number of species accessed for the
p.(None): elaboration of the finished product or reproductive material.
p.(None): § 2 The fine penalty is applied twice if there is commercialization abroad of finished product or reproductive material developed as a result of the
p.(None): access.
...
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 50,000.00 (fifty thousand reais) and maximum of R $ 500,000.00 (five hundred thousand reais), for other legal entities.
p.(None): § 1 The sanction of a fine may be replaced by a warning, when the circumstances provided for in art. 72.
p.(None): § 2 The provisions of § 1 do not apply to cases in which the offense involves access to associated traditional knowledge or when the offender is
p.(None): repeated under this Decree.
p.(None): Art. 83. Access associated traditional knowledge of identifiable origin without obtaining prior informed consent, or in disagreement with it.
p.(None): Minimum fine of R $ 20,000.00 (twenty thousand reais) and maximum of R $ 100,000.00 (one hundred thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 50,000.00 (fifty thousand reais) and maximum of R $ 500,000.00 (five hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of December 14, 2006.
p.(None): Minimum fine of R $ 100,000.00 (one hundred thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): Single paragraph. The same sanctions apply to those who obtain prior informed consent from the knowledge provider
p.(None): traditional associated under the terms of the Civil Code.
p.(None): Art. 84. Failing to indicate the origin of associated traditional knowledge of identifiable origin in publications, uses, explorations and disclosures of
p.(None): access results.
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 10,000.00 (ten thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of December 14, 2006.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 500,000.00 (five hundred thousand reais), for other legal entities.
p.(None): Art. 85. Failing to pay the annual installment due to the FNRB resulting from the economic exploitation of finished product or developed reproductive material
p.(None): due to access to genetic heritage or associated traditional knowledge.
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 100,000.00 (one hundred thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for legal entities.
p.(None): § 1 The same sanctions apply to anyone who interrupts or partially complies with the agreed benefit sharing, whether monetary or non-monetary.
p.(None): § 2 Observing the limits provided for in the caput, the fine should not be less than 10% (ten percent) nor more than 30% (thirty percent) of the amount annually
p.(None): due.
p.(None): Art. 86. To elaborate or present information, document, study, report or report totally or partially false, or misleading, either in the official systems or in
p.(None): any other administrative procedure related to genetic heritage or associated traditional knowledge:
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 30,000.00 (thirty thousand reais) and maximum of R $ 300,000.00 (three hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 100,000.00 (one hundred thousand reais) and maximum fine of R $ 5,000,000.00 (five million reais), for other legal entities.
p.(None): Single paragraph. The penalty provided for in the caput will be applied in double if the information, document, study, report or report totally or partially false or
p.(None): misleading information regarding the shipment or sending of a sample to provide services abroad.
p.(None): Art. 87. Failure to comply with suspension, embargo or interdiction resulting from administrative infraction against genetic heritage or traditional knowledge
p.(None): associated:
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 100,000.00 (one hundred thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 50,000.00 (fifty thousand reais) and maximum of R $ 500,000.00 (five hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 200,000.00 (two hundred thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): Art. 88. Obstate or hinder the inspection of the obligations provided for in Law nº 13.123, of 2015: Art.
p.(None): Minimum fine of R $ 5,000.00 (five thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 30,000.00 (thirty thousand reais) and maximum fine of R $ 300,000.00 (three hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
...
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): § 1 The sanction provided for in the caput will be applied for finished product or reproductive material or for each access activity, individually, that fails to
p.(None): promote their respective regularization regardless of the number of species accessed.
p.(None): § 2 the sanction of a fine may be replaced by a warning, when the circumstances provided for in art. 72, and whether:
p.(None): I - natural person; or
p.(None): II - legal entity that has made access to genetic heritage or associated traditional knowledge solely for the purpose of scientific research.
p.(None): Art. 91. Failure to meet legal or regulatory requirements, when notified by the competent authority within the period granted:
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 30,000.00 (thirty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 15,000.00 (fifteen thousand reais) and maximum fine of R $ 5,000,000.00 (five million reais), for other legal entities.
p.(None): Single paragraph. The fine sanction may be substituted for the warning, when the circumstances provided for in art. 72.
p.(None): Section IV
p.(None): Administrative procedure for investigating violations
p.(None): Art. 92. Infractions against genetic heritage or associated traditional knowledge will be investigated in a specific administrative process through the
p.(None): drawing up of notice of infraction and respective terms, ensuring the right to ample defense and the adversary.
p.(None): Single paragraph. The administrative process referred to in the caput will be governed by the provisions of Decree No. 6,514, of 2008, except when
p.(None): different provision provided for in this Chapter.
p.(None): Article 93. The following are competent to inspect and investigate the administrative infractions provided for in this Decree:
p.(None): I - Ibama;
p.(None): II - the Navy Command, within the scope of Brazilian jurisdictional waters and the continental shelf; and
p.(None): III - the Ministry of Agriculture, Livestock and Supply, within the scope of access to genetic heritage for agricultural activities, under the terms of art.
p.(None): 3 of Law No. 10,883, of June 16, 2004.
p.(None): § 1 When the offense involves associated traditional knowledge, the official bodies that defend the rights of indigenous peoples, communities
p.(None): traditional farmers and traditional farmers will provide support to Ibama's inspection activities.
p.(None): § 2 Joint act of the Ministers of State for the Environment, Agriculture, Livestock and Supply and Defense will regulate the coordinated action of the
p.(None): supervisory bodies.
p.(None): Art. 94. Of the final decision issued by the bodies provided for in art. 93 CGen may appeal within twenty days.
p.(None): Art. 95. CGen act will establish criteria for the destination of the seized samples, products and instruments, referred to in § 4 of art. 27 of Law nº
p.(None): 13,123, 2015.
p.(None): Single paragraph. As long as the act referred to in the caput has not been edited, the competent authority for inspection shall make the destination, observing the provisions
p.(None): in Decree No. 6,514, of 2008.
p.(None): CHAPTER VII
p.(None): THE NATIONAL BENEFIT SHARING FUND AND THE NATIONAL BENEFIT SHARING PROGRAM
p.(None): Art. 96. The National Benefit Sharing Fund - FNRB, established by Law No. 13,123, of 2015, linked to the Ministry of the Environment, is of a nature
p.(None): financial and is intended to support actions and activities aimed at enhancing the genetic heritage and associated traditional knowledge and promoting their use of
p.(None): sustainable way.
p.(None): § 1 The FNRB's revenue comprises:
p.(None): I - appropriations enshrined in the annual budget law and their additional credits;
p.(None): II - donations;
p.(None): III - amounts collected with the payment of administrative fines imposed due to non-compliance with Law No. 13,123, of 2015;
p.(None): IV - external financial resources arising from contracts, agreements or covenants, especially reserved for the Fund's purposes;
p.(None): V - contributions made by users of genetic heritage or associated traditional knowledge to the National Benefit Sharing Program;
p.(None): VI - amounts arising from the sharing of benefits; and
p.(None): VII - other revenues that may be allocated to it.
p.(None): § 2 The monetary resources deposited in the FNRB resulting from the economic exploitation of finished product or reproductive material arising from access to
p.(None): associated traditional knowledge will be used exclusively for actions, activities and projects for the benefit of holders of traditional knowledge
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p.(None): Art. 98. The Management Committee is responsible for:
p.(None): I - decide on the management of the monetary resources deposited in the FNRB, observing the guidelines for the application of the resources established by CGen;
p.(None): II - to define, annually, the percentage of the monetary resources deposited in the FNRB resulting from the economic exploitation of finished product or material
p.(None): reproductive system resulting from access to genetic heritage from ex situ collections, which will be used for the benefit of these collections;
p.(None): III - approve the FNRB Operations Manual, establishing conditions and procedures for the financial execution and the application of resources, including the
p.(None): revenue collection and the hiring, execution, monitoring and evaluation of actions and activities supported by the FNRB;
p.(None): IV - approve the four-year operating plan and review it every two years;
p.(None): V - approve actions, activities and projects to be supported by the FNRB;
p.(None): VI - decide on the hiring of studies and research by the FNRB;
p.(None): VII - approve annual reports of:
p.(None): a) activities and financial execution;
p.(None): b) performance of the financial institution;
p.(None): VIII - establish cooperation instruments, including with States, the Federal District and Municipalities;
p.(None): IX - establish instruments of cooperation and transfer of resources with national public institutions for research, teaching and technical support, including with support
p.(None): financial of FNRB, to follow the actions and activities supported by FNRB; and
p.(None): X - prepare and approve its internal regulations.
p.(None): Single paragraph. The percentage referred to in item II of the caput may not be less than sixty percent or greater than eighty percent.
p.(None): Art. 99. The availability of the FNRB will be maintained in a federal financial institution, which will be responsible for the administration and financial execution of the resources and
p.(None): operationalization of the Fund.
p.(None): Paragraph 1 The depositary fi nancial institution will remunerate the Fund's availabilities, at least, at the average reference rate of the Special Settlement System and of
p.(None): Custody - Selic.
p.(None): § 2 The financial institution's obligations and responsibilities, as well as its remuneration, will be defined in the contract.
p.(None): Art. 100. The National Benefit Sharing Program - PNRB, instituted by art. 33 of Law No. 13,123, of 2015, aims to promote:
p.(None): I - conservation of biological diversity;
p.(None): II - recovery, creation and maintenance of ex situ collections of samples of genetic heritage;
p.(None): III - prospection and training of human resources associated with the use and conservation of genetic heritage or associated traditional knowledge;
p.(None): IV - protection, promotion of the use and enhancement of associated traditional knowledge;
p.(None): V - implementation and development of activities related to the sustainable use of biological diversity, its conservation and benefit sharing;
p.(None): VI - fostering research and technological development associated with genetic heritage and associated traditional knowledge;
...
p.(None): this purpose with a view to improving the sustainable use of genetic heritage;
p.(None): XI - monitoring and maintaining the viability, the degree of variation and the integrity of the genetic heritage maintained by collections;
p.(None): XII - adoption of measures to minimize or, if possible, eliminate threats to genetic heritage;
p.(None): XIII - development and maintenance of the various cultivation systems that favor the sustainable use of genetic heritage;
p.(None): XIV - elaboration and execution of Sustainable Development Plans for Traditional Populations or Communities; and
p.(None): XV - other actions related to access to genetic heritage and associated traditional knowledge, as defined by the FNRB Management Committee.
p.(None): § 1 The FNRB may support projects and training activities for the employees of the bodies and entities referred to in § 2 of art. 14.
p.(None): § 2 The FNRB may support projects and activities related to the elaboration of community protocols.
p.(None): Art. 101. FNRB resources must be used in the PNRB to support actions and activities that promote the objectives provided for in art. 100, through
p.(None): agreements, terms of partnership, collaboration or promotion, agreements, adjustments or other instruments of cooperation and transfer of resources provided for by law.
p.(None): Single paragraph. FNRB resources may also be allocated:
p.(None): I - the analysis, supervision, management and monitoring of supported actions, activities and projects;
p.(None): II - the remuneration and coverage of the expenses of the financial institution related to the administration of the Fund.
p.(None): Art. 102. The Ministry of the Environment will exercise the function of Executive Secretary of the FNRB Management Committee and will provide technical and administrative support
p.(None): necessary for the functioning of the FNRB and implementation of the PNRB.
p.(None): CHAPTER VIII
p.(None): TRANSITIONAL PROVISIONS ON FITNESS AND REGULARIZATION OF ACTIVITIES
p.(None): Art. 103. It shall conform to the terms of Law No. 13,123, of 2015, and of this Decree, within one year, counting from the date of the registration being made available by
p.(None): CGen, the user who performed, as of June 30, 2000, the following activities in accordance with Provisional Measure No. 2,186-16, of August 23, 2001:
p.(None): I - access to genetic heritage or associated traditional knowledge; and
p.(None): II - economic exploitation of finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge.
p.(None): § 1 For the purposes of the caput, the user, observing art. 44 of Law No. 13,123, of 2015, must adopt one or more of the following measures, as
p.(None): the case:
p.(None): I - register access to genetic heritage or associated traditional knowledge;
...
p.(None): exempted from signing the Term of Commitment, being regularized through registration or authorization of the activity, as the case may be.
p.(None): § 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 2001, and
p.(None): specified in arts. 15 and 20 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 the
p.(None): Law No. 13,123, of 2015.
p.(None): § 4 For the purposes of regularizing the patent applications filed at the INPI during the term of Provisional Measure 2,186-16, of 2001, the applicant must
p.(None): present the proof of registration or authorization referred to in this article.
p.(None): § 5º The user who performed activities in disagreement with Provisional Measure nº 2.186-16, of 2001, even though he obtained authorization during the term of the
p.(None): said Provisional Measure, may, at its discretion, adhere to the regularization process provided for in art. 38 of Law No. 13,123, of 2015.
p.(None): § 6 For the purposes of § 5, the contract for the use of genetic heritage and the sharing of benefits or the project for the sharing of benefits, annulled by the
p.(None): CGen will integrate the commitment term.
p.(None): CHAPTER IX
p.(None): FINAL DISPOSITIONS
p.(None): Art. 105. For the purposes of the provision in item XVII of art. 2 of Law No. 13,123, 2015, the inputs used in agricultural activities are intermediate products.
p.(None): Single paragraph. Inputs for agricultural activities are goods that are consumed in the production activity or that undergo changes, such as
p.(None): wear, damage or loss of physical or chemical properties, depending on the action directly exerted on the product being manufactured, provided they are not
p.(None): included in property, plant and equipment.
p.(None): Art. 106. CGen may create a database for voluntary registration of prior informed consent, granted or denied by the holders of
p.(None): associated traditional knowledge.
p.(None): Art. 107. The following tests, exams and activities, when they are not an integral part of research or technological development, do not configure access to the
p.(None): genetic heritage under the terms of Law No. 13,123, of 2015:
p.(None): I - affiliation or paternity test, sexing technique and karyotype or DNA analysis and other molecular analyzes aimed at the identification of a species
p.(None): or specimen;
p.(None): II - diagnostic tests and clinical examinations for the direct or indirect identification of aetiological agents or hereditary pathologies in an individual;
p.(None): III - extraction, by means of grinding, pressing or bleeding that results in fixed oils;
p.(None): IV - purification of fixed oils that results in a product whose characteristics are identical to those of the original raw material;
p.(None): V - test that aims to assess mortality rates, growth or multiplication of parasites, pathogens, pests and disease vectors;
p.(None): VI - comparison and extraction of information of genetic origin available in national and international databases
p.(None): VI - extracts processing, physical separation, pasteurization, fermentation, pH assessment, total acidity, soluble solids, bacteria and yeast count,
p.(None): molds, faecal coliforms and totals of genetic heritage samples; and
p.(None): VII - physical, chemical and physical-chemical characterization for determining the nutritional information of foods;
p.(None): Single paragraph. It does not configure access to genetic heritage to read or consult information of genetic origin available in databases
p.(None): national and international, even though they are an integral part of technological research and development.
p.(None): Art. 108. The plant or animal genetic improvement carried out by an indigenous population, traditional community or traditional farmer is exempt from registration in the
p.(None): terms of item VI of art. 10 of Law No. 13,123, of 2015.
p.(None): Art. 109. To comply with the provisions of § 2 of art. 12 of Law No. 13,123, of 2015, the user, when requesting intellectual property rights, must
p.(None): inform whether there was access to genetic heritage or associated traditional knowledge, as well as whether there is an access register carried out under the terms of this Decree.
p.(None): Art. 110. If the registration does not exist or in case of its cancellation, Ibama or CGen will communicate the organ and entity provided for in art. 109 for
p.(None): that the applicant for the intellectual property right to present proof of registration in thirty days, under penalty of
p.(None): intellectual property right application.
p.(None): Single paragraph. In the event of no registration, the period of one year referred to in arts. 36, 37 and 38 of Law No. 13,123, of 2015.
p.(None): Art. 111. CGen, with the collaboration of accredited institutions under the terms of item V of art. 15 of Provisional Measure No. 2,186-16, of 2001, will register in the
p.(None): authorizations already issued.
p.(None): Art. 112. Based on the Common Nomenclature of Mercosur - NCM, the List of Classification of Benefit Sharing referred to in § 9 of art.
p.(None): 17 of Law No. 13,123, of 2015, attached to this Decree.
p.(None): Single paragraph. The list referred to in the caput will have an exemplary character and will not exclude the application of the benefit sharing incidence rules
p.(None): provided for in arts. 17 and 18 of Law No. 13,123, of 2015.
p.(None): Art. 113. The Ministry of Agriculture, Livestock and Supply will periodically prepare, publish and review the reference list of animal and plant species
p.(None): domesticated or cultivated that were introduced in the national territory, used in agricultural activities.
p.(None): Single paragraph. The list referred to in the caput will indicate the species that form spontaneous populations and the varieties that have acquired properties
p.(None): distinctive characteristics in the country.
p.(None): Art. 114. Joint act of the Ministers of State for Agriculture, Livestock and Supply and Agrarian Development will publish a list of traditional varieties
p.(None): local or Creole and locally adapted or Creole breeds.
p.(None): Art. 115. The Ministry of Health and the Ministry of the Environment, in a joint Ordinance, will regulate a simplified procedure for carrying out remittances.
p.(None): genetic heritage related to the Public Health Emergency Situation of National Importance - ESPIN, which is dealt with in Decree nº 7.616, of November 17,
p.(None): 2011.
p.(None): § 1 The consignment provided for in the caput will be destined exclusively to research and technological development declared in the Material Transfer Term,
p.(None): necessarily linked to the epidemiological situation, and the use of this genetic heritage accessed for other purposes is prohibited.
p.(None): § 2 The benefits resulting from the economic exploitation of the finished product or reproductive material arising from research or technological development that
p.(None): this article deals with will be distributed under the terms of Law No. 13,123, 2015, and this Decree.
p.(None): Art. 116. The Ministry of the Environment, in coordination with the Ministry of Foreign Affairs, may enter into cooperation agreements and agreements with
p.(None): entities in other countries for the purpose of complying with the provisions of Law No. 13,123 of 2015.
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Social / Property Ownership
Searching for indicator property:
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p.(None): access to genetic heritage or associated traditional knowledge, including those related to economic exploitation.
p.(None): § 1 Under the terms of art. 7 of Law No. 13,123 of 2015, the system provided for in the caput will be managed by the Executive Secretariat of CGen and will have the
p.(None): information necessary for the traceability of activities resulting from access to genetic heritage or associated traditional knowledge
p.(None): systems databases:
p.(None): I - protection and registration of cultivars, seeds and seedlings, agricultural products, establishments and inputs, traffic information
p.(None): international agricultural products and inputs from the Ministry of Agriculture, Livestock and Supply;
p.(None): II - import and export registration under the Integrated Foreign Trade System - Siscomex, instituted by Decree No. 660, of September 25,
p.(None): 1992;
p.(None): III - information on curricula, research groups, institutions registered on the Lattes Platform of the National Council for Scientific Development and
p.(None): Technological - CNPq;
p.(None): IV - information on research and commercial release of genetically modified organisms and derivatives, from the National Technical Commission for
p.(None): Biosafety - CTNBio from the Ministry of Science, Technology and Innovation;
p.(None): V - registration of products from the National Health Surveillance Agency - Anvisa;
p.(None): VI - granting and guaranteeing intellectual property rights of the National Institute of Industrial Property - INPI;
p.(None): VII - national register of social information of the Ministry of Social Development and Fight against Hunger; and
p.(None): VIII - information on cultural heritage of the National Information and Cultural Indicators System - SNIIC, of the Ministry of Culture.
p.(None): § 2 The bodies and entities referred to in this article shall adopt the necessary measures to guarantee access to information through the traceability system and the
p.(None): Ministry of the Environment will adopt the necessary measures for the integration of the information contained in the databases provided for in § 1.
p.(None): § 3 In the impossibility of adopting the measures provided for in § 2, the information must be forwarded to CGen within thirty days, counted from the
p.(None): solicitation.
p.(None): § 4 CGen may also:
p.(None): I - request additional information from the bodies and entities provided for in § 1;
p.(None): II - to request other organs and entities of the federal public administration information that it deems necessary for the traceability of activities
p.(None): arising from access to genetic heritage or associated traditional knowledge; and
p.(None): III - adopt measures to guarantee access to information through the traceability system and the integration of databases with different bodies and entities
p.(None): those provided for in items I to VIII of §1 of the caput.
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p.(None): TRADITIONAL ASSOCIATE - SISGEN
p.(None): Section I
p.(None): General provisions
p.(None): Art. 20. The National System for the Management of Genetic Heritage and Associated Traditional Knowledge - SisGen is created, an electronic system to be implemented,
p.(None): maintained and operated by the CGen Executive Secretariat for management:
p.(None): I - the register of access to genetic heritage or associated traditional knowledge, as well as the register for sending a sample containing
p.(None): genetic heritage to provide services abroad;
p.(None): II - the record of sending a sample of genetic heritage and the Material Transfer Term;
p.(None): III - authorizations for access to genetic heritage or associated traditional knowledge and remittance abroad, in the cases referred to in art. 13
p.(None): of Law No. 13,123, of 2015;
p.(None): IV - the accreditation of the institutions that maintain the ex situ collections that contain samples of genetic heritage;
p.(None): V - notifications of finished product or reproductive material and benefit sharing agreements; and
p.(None): VI - certificates of regularity of access.
p.(None): § 1 The registration must be carried out in advance:
p.(None): I - the shipment;
p.(None): II - the application for any intellectual property right;
p.(None): III - the commercialization of the intermediate product;
p.(None): IV - the dissemination of results, final or partial, in scientific or communication media; or
p.(None): V - notification of finished product or reproductive material developed as a result of access.
p.(None): § 2 If there are changes in fact or in law in the information provided to SisGen, the user must update his records or noti fi cation,
p.(None): at least once a year.
p.(None): § 3 The update referred to in § 2 must also be carried out to include information regarding the application for any intellectual property right
p.(None): or patent licensing.
p.(None): Art. 21. The information contained in the SisGen is public, except for those that, upon user's request, are considered confidential.
p.(None): Single paragraph. The request referred to in the caput must indicate the relevant legal basis and be accompanied by a non-confidential summary.
p.(None): Section II
p.(None): The register of access to genetic heritage or associated traditional knowledge and the register
p.(None): sending a sample containing genetic heritage to provide services abroad
p.(None): Art. 22. For the registration of access to genetic heritage or associated traditional knowledge, the natural or legal person must
p.(None): complete the electronic SisGen form which will require:
p.(None): I - user identification;
p.(None): II - information on research or technological development activities, including:
p.(None): a) summary of the activity and its respective objectives;
p.(None): b) application sector, in the case of technological development;
p.(None): c) expected or obtained results, depending on the moment of registration;
p.(None): d) responsible team, including partner institutions, if any;
p.(None): e) period of activities;
p.(None): f) identification of genetic heritage at the strictest possible taxonomic level or associated traditional knowledge, as the case may be, in particular:
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p.(None): Paragraph 3. If it is not possible to inform the georeferenced coordinates referred to in item II of Paragraph 2, the user must inform the geographical location more
p.(None): possible.
p.(None): § 4º CGen will define in technical standard:
p.(None): I - the strictest taxonomic level to be informed, in research cases with the objective of evaluating or elucidating the genetic diversity or the evolutionary history of
p.(None): a taxonomic species or group;
p.(None): II - how to indicate the most specific geographic location possible, in cases where access is exclusively for research purposes in which they are
p.(None): more than one hundred records of origin are required per registration; and
p.(None): III - how to indicate the genetic heritage, in cases of access from samples of substrates containing non-isolated microorganisms.
p.(None): § 5 The user must perform a new registration when there is a change in the genetic heritage or associated traditional knowledge accessed or the objective
p.(None): access.
p.(None): Art. 23. After completing the form referred to in art. 22 SisGen will automatically issue proof of access registration.
p.(None): § 1 The proof of access registration constitutes a suitable document to demonstrate that the user provided the information that was required and produces the
p.(None): following effects:
p.(None): I - allows, under the terms of § 2 of art. 12 of Law No. 13,123, of 2015:
p.(None): a) the application for any property and intellectual rights;
p.(None): b) the commercialization of an intermediate product;
p.(None): c) the dissemination of the results, final or partial, of research or technological development, in scientific or communication media; and
p.(None): d) notification of finished product or reproductive material developed as a result of access; and
p.(None): II - establishes the start of the verification procedure provided for in Section VII of this Chapter.
p.(None): § 2º The user will not need to wait for the verification procedure to finish to carry out the activities referred to in item I of § 1.
p.(None): Art. 24. Sisgen will provide an electronic form in the access register so that the national legal entity, public or private, registers the sending of a sample
p.(None): that contains genetic heritage for the provision of services abroad as part of research or technological development.
p.(None): § 1 The national legal entity, public or private, may authorize the natural person responsible for technological research or development to complete the
p.(None): shipping register.
p.(None): § 2 The registration register referred to in the caput will require:
p.(None): I - information about the recipient institution abroad, including contact information and indication of legal representative; and
p.(None): II - information of the samples to be sent, containing the identification of the genetic heritage to be sent.
p.(None): § 3 The sending of a sample containing genetic heritage for the provision of services abroad, under the terms of item XXX of art. 2 of Law No. 13,123, of
...
p.(None): Paragraph 5. The consideration or consideration provided for in Paragraph 4 may be waived when the partner institution integrates the research as a co-author, subject to the provisions
p.(None): in § 6.
p.(None): § 6 The legal instrument signed between the national institution responsible for access and the partner or contracted institution must contain:
p.(None): I - identification of genetic heritage at the strictest possible taxonomic level, subject to the provisions of § 4 of art. 22;
p.(None): II - information on:
p.(None): a) the type of sample and the form of packaging; and
p.(None): b) the number of containers, the volume or the weight;
p.(None): III - description of the specialized technical service object of the provision;
p.(None): IV - obligation to return or destroy the samples sent;
p.(None): V - breakdown of the term for the provision of services, detailing by activity to be performed, when applicable; and
p.(None): VI - clauses prohibiting the partner institution or contractor from:
p.(None): a) pass on the sample of the genetic heritage or the information of genetic origin of the species to be sent, including substances from the metabolism
p.(None): these beings to third parties;
p.(None): b) use the sample of genetic heritage or information of genetic origin of the species to be sent for any purpose other than those provided for;
p.(None): c) economically exploit intermediate or finished product or reproductive material resulting from access; and
p.(None): d) request any type of intellectual property right.
p.(None): § 7 The legal instrument referred to in § 6 will not be mandatory in cases of sending a sample for genetic sequencing.
p.(None): § 8 In the case of § 7, the user must formally communicate to the partner or contracted institution the obligations provided for in items IV and VI of § 6.
p.(None): § 9 The registration of sample submission must be carried out within the deadlines defined for the access registration.
p.(None): § 10. The samples to be sent must be accompanied by:
p.(None): I - the legal instrument referred to in § 6; and
p.(None): II - prior informed consent, in case of sending a sample of genetic heritage of a traditional local or creole variety or locally adapted breed
p.(None): or Creole for access in non-agricultural activities, when applicable.
p.(None): Section III
p.(None): From the record of sending a sample of genetic heritage and the Material Transfer Term
p.(None): Art. 25. In order to register the shipment of a sample of genetic heritage, the natural or legal person must complete the form
p.(None): electronic SisGen that will require:
p.(None): I - identification:
p.(None): a) the sender;
p.(None): b) samples of genetic heritage at the strictest possible taxonomic level; and
p.(None): c) the origin of the samples to be sent, observing the provisions of item 1 of item “f” of item II, in § 1 and in item II of § 4 of art. 22;
p.(None): II - information on:
p.(None): a) the type of sample and the form of packaging;
p.(None): b) the number of containers, the volume or the weight;
...
p.(None): § 1 The notification referred to in the caput must be made before the beginning of the economic exploration.
p.(None): § 2 For the purposes of paragraph 1, economic exploration is considered to have started when the first fiscal note for the sale of the finished product is issued or
p.(None): reproductive material.
p.(None): Art. 34. For the notification of the finished product or reproductive material arising from access to genetic heritage or traditional knowledge
p.(None): associated, the user must fill in the electronic form of SisGen, which will require:
p.(None): I - identification of the requesting natural or legal person;
p.(None): II - commercial identification of the finished product or reproductive material and application sector;
p.(None): III - information if the genetic heritage or the associated traditional knowledge used in the finished product is decisive for the formation of the appeal
p.(None): marketing;
p.(None): IV - information on whether the genetic heritage or the associated traditional knowledge used in the finished product is decisive for the existence of
p.(None): functional characteristics;
p.(None): V - forecast of the local, regional, national or international scope of the manufacture and commercialization of the finished product or reproductive material;
p.(None): VI - registration number, or equivalent, of a product or cultivar in a competent organ or entity, such as Anvisa, Ministry of Agriculture, Livestock and
p.(None): Supply and the Brazilian Institute for the Environment and Renewable Natural Resources - Ibama;
p.(None): VII - number of the deposit for requesting intellectual property rights for a product or cultivar at the Ministry of Agriculture, Livestock and Supply or at the INPI,
p.(None): or in offices abroad, if any;
p.(None): VIII - estimated date for the start of commercialization;
p.(None): IX - indication of the type of benefit sharing;
p.(None): X - presentation of a benefit sharing agreement, when applicable;
p.(None): XI - numbers of the records of access to genetic heritage or associated traditional knowledge that gave rise to the finished product or material
p.(None): reproductive system, subject to the provisions of art. 2 and in Chapter VIII of this Decree;
p.(None): XII - numbers of the shipping records that gave rise to the finished product or reproductive material, if any;
p.(None): XIII - request for recognition of legal secrecy hypothesis; and
p.(None): XIV - proof of compliance in the event of legal exemption or non-incidence of benefit sharing.
p.(None): Single paragraph. The benefit-sharing agreement must be submitted:
p.(None): I - at the time of notification, in the case of access to associated traditional knowledge of identifiable origin; or
p.(None): II - within three hundred and sixty-five days from the notification of the finished product or reproductive material.
p.(None): Art. 35. After completing the form referred to in art. 34 SisGen will automatically issue proof of notification.
p.(None): § 1 The proof of notification constitutes a suitable document to demonstrate that the user provided the information that was required and produces the following
p.(None): effects:
p.(None): I - allows the economic exploitation of the finished product or reproductive material, subject to the provisions of art. 16 of Law No. 13,123, of 2015; and
...
p.(None): IX - ex situ collections maintained by accredited institutions under the terms of Chapter IV, Section V; and
p.(None): X - indigenous populations, traditional communities and traditional farmers.
p.(None): Art. 52. In the case of item II of art. 50 the sharing of non-monetary benefits referred to in points “b”, “c”, “d” and “f” of item II of art. 19 of Law nº
p.(None): 13,123, from 2015, will be destined to national public bodies and institutions that execute social interest programs.
p.(None): Art. 53. The Ministry of the Environment may create and maintain the bank of proposals for the sharing of non-monetary benefits, which will be widely publicized,
p.(None): including through its website, to comply with the provisions of item II of art. 19 of Law No. 13,123 of 2015.
p.(None): Single paragraph. The proposals referred to in the caput should be aimed at the conservation and sustainable use of biodiversity, valuing and protecting the
p.(None): associated traditional knowledge, serving the public interest.
p.(None): Section IV
p.(None): Exemptions from benefit sharing
p.(None): Art. 54. Economic exploitation of:
p.(None): I - finished product or reproductive material developed by traditional farmers and their cooperatives, with annual gross revenue equal to or less than the limit
p.(None): maximum established in item II of art. 3 of Complementary Law No. 123, of December 14, 2006;
p.(None): II - finished product or reproductive material developed by micro-enterprises, small businesses and individual micro-entrepreneurs,
p.(None): as provided in Complementary Law No. 123, of 2006;
p.(None): III - operations for licensing, transferring or allowing the use of any form of intellectual property right over the finished product,
p.(None): reproductive process or material arising from access to genetic heritage or traditional knowledge associated by third parties;
p.(None): IV - intermediate products along the production chain;
p.(None): V - reproductive material along the productive chain of reproductive material, except for the economic exploitation carried out by the last link in the productive chain;
p.(None): VI - reproductive material arising from access to genetic heritage or associated traditional knowledge for the purposes of agricultural activities and intended
p.(None): exclusively to the generation of finished products; and
p.(None): VII - finished product or reproductive material arising from access to the genetic heritage of species introduced into the national territory by human action, still
p.(None): domesticated, except for the provisions of items I and II of § 3 of art. 18 of Law No. 13,123, of 2015.
p.(None): § 1 The exchange and dissemination of genetic heritage and associated traditional knowledge are also exempt from the obligation to share benefits.
p.(None): practiced among indigenous peoples, traditional communities or traditional farmers for their own benefit and based on their uses, customs and
p.(None): traditions;
p.(None): § 2 The exemption from the benefit sharing referred to in the caput does not relieve the user from the obligation to notify the finished product or reproductive material as
...
p.(None): Art. 79. Send, directly or through an intermediary, a sample of genetic heritage abroad without prior registration or in disagreement with it.
p.(None): Minimum fine of R $ 20,000.00 (twenty thousand reais) and maximum of R $ 100,000.00 (one hundred thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 50,000.00 (fifty thousand reais) and maximum of R $ 500,000.00 (five hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 100,000.00 (one hundred thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): § 1 The sanction provided for in the caput will be applied:
p.(None): I - by species;
p.(None): II - in triple if the sample is obtained from species included in official lists of Brazilian species threatened with extinction or from Annex I of the Convention
p.(None): on International Trade in Endangered Species of Wild Flora and Fauna - CITES, promulgated by Decree No. 76,623, of November 17,
p.(None): 1975; and
p.(None): III - twice if the sample is obtained from a species contained only in CITES Appendix II, promulgated by Decree nº 76.623, of 1975.
p.(None): § 2 If the remittance is made for the development of biological or chemical weapons, the penalty provided for in the caput will be quadrupled and must be applied
p.(None): the sanctions of embargo, suspension or partial or total interdiction of the establishment, activity or enterprise, of the person responsible for the consignment.
p.(None): Art. 80. Requesting intellectual property rights resulting from access to genetic heritage or associated traditional knowledge, in Brazil or abroad,
p.(None): without prior registration.
p.(None): Minimum fine of R $ 3,000.00 (three thousand reais) and maximum fine of R $ 30,000.00 (thirty thousand reais), in the case of a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 20,000.00 (twenty thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): Art. 81. Disseminate results, final or partial, in scientific or communication media without prior registration:
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 20,000.00 (twenty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 50,000.00 (fifty thousand reais) and maximum of R $ 500,000.00 (five hundred thousand reais), for other legal entities.
p.(None): § 1 The sanction of a fine may be replaced by a warning, when the circumstances provided for in art. 72.
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p.(None): § 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 2001, and
p.(None): specified in arts. 15 and 20 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 the
p.(None): Law No. 13,123, of 2015.
p.(None): § 4 For the purposes of regularizing the patent applications filed at the INPI during the term of Provisional Measure 2,186-16, of 2001, the applicant must
p.(None): present the proof of registration or authorization referred to in this article.
p.(None): § 5º The user who performed activities in disagreement with Provisional Measure nº 2.186-16, of 2001, even though he obtained authorization during the term of the
p.(None): said Provisional Measure, may, at its discretion, adhere to the regularization process provided for in art. 38 of Law No. 13,123, of 2015.
p.(None): § 6 For the purposes of § 5, the contract for the use of genetic heritage and the sharing of benefits or the project for the sharing of benefits, annulled by the
p.(None): CGen will integrate the commitment term.
p.(None): CHAPTER IX
p.(None): FINAL DISPOSITIONS
p.(None): Art. 105. For the purposes of the provision in item XVII of art. 2 of Law No. 13,123, 2015, the inputs used in agricultural activities are intermediate products.
p.(None): Single paragraph. Inputs for agricultural activities are goods that are consumed in the production activity or that undergo changes, such as
p.(None): wear, damage or loss of physical or chemical properties, depending on the action directly exerted on the product being manufactured, provided they are not
p.(None): included in property, plant and equipment.
p.(None): Art. 106. CGen may create a database for voluntary registration of prior informed consent, granted or denied by the holders of
p.(None): associated traditional knowledge.
p.(None): Art. 107. The following tests, exams and activities, when they are not an integral part of research or technological development, do not configure access to the
p.(None): genetic heritage under the terms of Law No. 13,123, of 2015:
p.(None): I - affiliation or paternity test, sexing technique and karyotype or DNA analysis and other molecular analyzes aimed at the identification of a species
p.(None): or specimen;
p.(None): II - diagnostic tests and clinical examinations for the direct or indirect identification of aetiological agents or hereditary pathologies in an individual;
p.(None): III - extraction, by means of grinding, pressing or bleeding that results in fixed oils;
p.(None): IV - purification of fixed oils that results in a product whose characteristics are identical to those of the original raw material;
p.(None): V - test that aims to assess mortality rates, growth or multiplication of parasites, pathogens, pests and disease vectors;
p.(None): VI - comparison and extraction of information of genetic origin available in national and international databases
p.(None): VI - extracts processing, physical separation, pasteurization, fermentation, pH assessment, total acidity, soluble solids, bacteria and yeast count,
p.(None): molds, faecal coliforms and totals of genetic heritage samples; and
p.(None): VII - physical, chemical and physical-chemical characterization for determining the nutritional information of foods;
p.(None): Single paragraph. It does not configure access to genetic heritage to read or consult information of genetic origin available in databases
p.(None): national and international, even though they are an integral part of technological research and development.
p.(None): Art. 108. The plant or animal genetic improvement carried out by an indigenous population, traditional community or traditional farmer is exempt from registration in the
p.(None): terms of item VI of art. 10 of Law No. 13,123, of 2015.
p.(None): Art. 109. To comply with the provisions of § 2 of art. 12 of Law No. 13,123, of 2015, the user, when requesting intellectual property rights, must
p.(None): inform whether there was access to genetic heritage or associated traditional knowledge, as well as whether there is an access register carried out under the terms of this Decree.
p.(None): Art. 110. If the registration does not exist or in case of its cancellation, Ibama or CGen will communicate the organ and entity provided for in art. 109 for
p.(None): that the applicant for the intellectual property right to present proof of registration in thirty days, under penalty of
p.(None): intellectual property right application.
p.(None): Single paragraph. In the event of no registration, the period of one year referred to in arts. 36, 37 and 38 of Law No. 13,123, of 2015.
p.(None): Art. 111. CGen, with the collaboration of accredited institutions under the terms of item V of art. 15 of Provisional Measure No. 2,186-16, of 2001, will register in the
p.(None): authorizations already issued.
p.(None): Art. 112. Based on the Common Nomenclature of Mercosur - NCM, the List of Classification of Benefit Sharing referred to in § 9 of art.
p.(None): 17 of Law No. 13,123, of 2015, attached to this Decree.
p.(None): Single paragraph. The list referred to in the caput will have an exemplary character and will not exclude the application of the benefit sharing incidence rules
p.(None): provided for in arts. 17 and 18 of Law No. 13,123, of 2015.
p.(None): Art. 113. The Ministry of Agriculture, Livestock and Supply will periodically prepare, publish and review the reference list of animal and plant species
p.(None): domesticated or cultivated that were introduced in the national territory, used in agricultural activities.
p.(None): Single paragraph. The list referred to in the caput will indicate the species that form spontaneous populations and the varieties that have acquired properties
p.(None): distinctive characteristics in the country.
p.(None): Art. 114. Joint act of the Ministers of State for Agriculture, Livestock and Supply and Agrarian Development will publish a list of traditional varieties
p.(None): local or Creole and locally adapted or Creole breeds.
p.(None): Art. 115. The Ministry of Health and the Ministry of the Environment, in a joint Ordinance, will regulate a simplified procedure for carrying out remittances.
p.(None): genetic heritage related to the Public Health Emergency Situation of National Importance - ESPIN, which is dealt with in Decree nº 7.616, of November 17,
p.(None): 2011.
p.(None): § 1 The consignment provided for in the caput will be destined exclusively to research and technological development declared in the Material Transfer Term,
p.(None): necessarily linked to the epidemiological situation, and the use of this genetic heritage accessed for other purposes is prohibited.
p.(None): § 2 The benefits resulting from the economic exploitation of the finished product or reproductive material arising from research or technological development that
p.(None): this article deals with will be distributed under the terms of Law No. 13,123, 2015, and this Decree.
p.(None): Art. 116. The Ministry of the Environment, in coordination with the Ministry of Foreign Affairs, may enter into cooperation agreements and agreements with
p.(None): entities in other countries for the purpose of complying with the provisions of Law No. 13,123 of 2015.
p.(None): Art. 117. The provisions of this Decree do not exclude the powers of the Ministry of Science, Technology and Innovation to supervise and control the activities of
p.(None): scientific research in the national territory, when carried out by foreigners, which imply entering the country.
p.(None): Art. 118. The user who requested any intellectual property right, economically exploited the finished product or reproductive material, or disclosed
p.(None): results, final or partial, in scientific or communication media, between November 17, 2015 and the date of availability of the registration, must register the
p.(None): activities referred to in art. 12 of Law No. 13,123, 2015 and notify the finished product or reproductive material developed as a result of access.
p.(None): Paragraph 1 The deadline for registration or notification referred to in the caput will be 1 (one) year, counted from the date the registration is made available by CGen.
p.(None): § 2 Once the registration or notification is made in a timely manner, the user will not be subject to administrative sanction.
p.(None): Art. 119. The following are revoked:
p.(None): I - Decree No. 3,945, of September 28, 2001;
p.(None): II - Decree No. 4,946, of December 31, 2003;
p.(None): III - Decree No. 5,459, of June 7, 2005;
p.(None): IV - Decree No. 6,159, of July 17, 2007; and
p.(None): V - Decree No. 6,915, of July 29, 2009.
p.(None): Art. 120. This Decree comes into force on the date of its publication.
p.(None): Brasília, May 11, 2016; 195th of Independence and 128th of the Republic.
p.(None): DILMA ROUSSEFF
p.(None): Eugênio José Guilherme de Aragão
p.(None): Kátia Abreu
p.(None): Fernando de Magalhães Furlan
p.(None): João Luiz Silva Ferreira
p.(None): Izabella Mônica Vieira Teixeira
p.(None): Patrus Ananias
p.(None): This text does not replace the one published in the DOU of 12.5.2016
p.(None): ATTACHMENT
p.(None): Benefit Sharing Classification List
p.(None): NCM Chapters Section
p.(None): Section I. LIVE ANIMALS AND PRODUCTS Chapters 1 to 5 01.01 to 0508.00.00
p.(None): OF THE ANIMAL KINGDOM
p.(None): Section II. KINGDOM PRODUCTS Chapters 6 to 14 06.01 to 14.04
p.(None): VEGETABLE
...
Social / Racial Minority
Searching for indicator race:
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p.(None): I - description of the history of the process for obtaining prior informed consent;
p.(None): II - the description of the traditional forms of organization and representation of the indigenous population, traditional community or traditional farmer;
p.(None): III - the objective of the research, as well as its methodology, duration, budget, possible benefits and sources of financing for the project;
p.(None): IV - the intended use of the associated traditional knowledge to be accessed; and
p.(None): V - the geographical area covered by the project and the indigenous populations, traditional communities or traditional farmers involved.
p.(None): Single paragraph. The instrument referred to in the caput must also expressly mention whether the indigenous population, the traditional community or the farmer
p.(None): traditional group received technical or legal advice during the process of obtaining prior informed consent.
p.(None): Art. 18. Access to the genetic heritage of the local or Creole traditional variety or to the locally adapted or Creole breed for agricultural activities comprises
p.(None): access to associated traditional knowledge of non-identifiable origin that gave rise to the variety or race and does not depend on prior consent from the
p.(None): indigenous population, traditional community or traditional farmer who creates, develops, owns or preserves the variety or breed.
p.(None): § 1 Under the terms of item XXIV of art. 2 of Law No. 13,123, of 2015, the activities of production, processing and
p.(None): commercialization of food, beverages, fibers, energy and planted forests.
p.(None): § 2 The biofuels, such as ethanol, biodiesel, biogas and cogeneration of electric energy from
p.(None): biomass processing.
p.(None): § 3 For activities that do not fit the concept of agricultural activity, access to the genetic heritage of a traditional local or Creole variety or to
p.(None): locally adapted or creole breed comprises the associated traditional knowledge that gave rise to the variety or breed, and will follow the rules of access to
p.(None): associated traditional knowledge set out in Law No. 13,123 of 2015 and in this Decree.
p.(None): § 4 In the case of access to the genetic heritage of a traditional local or creole variety referred to in the caput, the user must deposit reproductive material
p.(None): of the variety subject to access in an ex situ collection maintained by a public institution, except when the variety was obtained from the collection itself.
p.(None): Art. 19. Indigenous populations, traditional communities and traditional farmers who create, develop, hold or retain knowledge
...
Social / Religion
Searching for indicator faith:
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p.(None): Art. 40. Once the deadline for presenting the manifestation has expired, the Executive Secretariat will forward the process for deliberation of the CGen Plenary, which
p.(None): you can:
p.(None): I - not accept the merits of the application; or
p.(None): II - comply with the request, when:
p.(None): a) determine that the user retains the access or shipping records, or even the notification, if the irregularity is remedial, under penalty of
p.(None): cancellation of the respective registrations or notification; or
p.(None): b) cancel the access or remittance registrations, or even the notification, if the irregularity is insurmountable, and notify:
p.(None): 1. the bodies and entities referred to in arts. 93 and 109; and
p.(None): 2. the user, to make new registrations or notification.
p.(None): § 1 The following are insurmountable irregularities:
p.(None): I - the existence of associated traditional knowledge of identifiable origin when the registrations or notification indicate only genetic heritage;
p.(None): II - the existence of associated traditional knowledge of identifiable origin, when the registrations or notification indicate only traditional knowledge
p.(None): associate of unidentifiable origin; and
p.(None): III - obtaining prior informed consent in disagreement with the provisions of Law No. 13,123, 2015, and this Decree.
p.(None): § 2 If the finding of the irregularities referred to in items I, II and III of § 1 occurs when the economic exploitation of the product has already started
p.(None): finished or reproductive material, CGen, exceptionally, and as long as no bad faith is set, it may determine that the user retains the
p.(None): notification, and submit, within ninety days, the benefit sharing agreement with the associated traditional knowledge provider.
p.(None): § 3 In the event provided for in § 2, the benefit sharing for the entire corresponding calculation period will be calculated and collected in favor of the
p.(None): beneficiaries and the amounts provided for in the benefit sharing agreement in force on the date of payment.
p.(None): Art. 41. The user may request the issuance of a certificate stating that the respective access and remittance registers as well as the notification:
p.(None): I - applications for verification of evidence of irregularities were not admitted during the verification process; or
p.(None): II - that were subject to a verification request and that this was not accepted.
p.(None): Single paragraph. The certificate referred to in the caput allows the user to be initially warned by the inspection body or entity before receiving
p.(None): any other administrative sanction, if the assessment occurs on facts informed in the respective access and remittance registers as well as the notification.
p.(None): Section VIII
p.(None): The certificate of regularity of access
p.(None): Art. 42. CGen may issue the certificate of regularity of access referred to in item XXII of art. 2 of Law No. 13,123, 2015, upon request from the
p.(None): user.
p.(None): § 1 The certificate provided for in the caput states that the access register has complied with the requirements of Law No. 13,123, of 2015.
...
Social / Threat of Stigma
Searching for indicator threat:
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p.(None): also the fulfillment of the other obligations of Law No. 13,123, of 2015.
p.(None): § 3 The provision in § 2 does not apply to the cases provided for in § 4 of art. 8 of Law No. 13,123, of 2015.
p.(None): § 4 The user who fails to fulfill the exemption requirements provided for in Law No. 13,123, 2015, will share benefits in the following fiscal year.
p.(None): § 5 In the cases provided for in items IV, V and VI of the caput, the user must declare that the product or reproductive material fits as a product
p.(None): intermediate and will only be used for activities and processes along the reproductive chain.
p.(None): Section V
p.(None): The benefit-sharing agreement
p.(None): Art. 55. The benefit sharing agreement between user and provider will be negotiated in a fair and equitable manner between the parties, taking into account
p.(None): clarity, loyalty and transparency in the agreed clauses, which should indicate conditions, obligations, types and duration of short, medium and long term benefits,
p.(None): without prejudice to other guidelines and criteria to be established by CGen.
p.(None): Section VI
p.(None): Sectoral agreements
p.(None): Art. 56. The purpose of sectoral agreements is to guarantee the competitiveness of the productive sector in cases where the application of the 1% (one percent) portion of the
p.(None): annual net revenue obtained from the economic exploitation of the finished product or reproductive material arising from access to genetic heritage or knowledge
p.(None): traditional associate of unidentifiable origin characterizes material damage or threat of material damage.
p.(None): § 1 For the purposes of this Decree, the productive sector is the company or group of companies that produce a certain product or similar feature
p.(None): reduction request.
p.(None): Paragraph 2 In the event provided for in the caput, the percentage of payment of monetary benefit sharing may be reduced to up to 0.1% (one tenth percent)
p.(None): of the annual net revenue obtained from economic exploration.
p.(None): Art. 57. The request to reduce the value of the monetary benefit sharing will be addressed to the Ministry of the Environment and will depend on the demonstration that the
p.(None): payment of that percentage has resulted or will result in material damage.
p.(None): § 1 The confidential information contained in the caption referred to in the caput will be treated as so identified by the interested party, provided that the request is
p.(None): justified, and in this case it cannot be revealed without the express authorization of the interested party.
p.(None): § 2 The interested party that provided confidential information must present a summary to be published, with details that allow its understanding, under penalty of being
p.(None): considered non-confidential.
p.(None): § 3 If the Ministry of the Environment considers the request for confidential treatment unjustified and the interested party refuses to adapt it for annexation in
p.(None): non-confidential records, the information will not be known.
p.(None): Art. 58. The request for reduction of benefit sharing will only be known when the signatory companies hold more than:
p.(None): I - fifty percent of the sectorial production value, in the event that said production is concentrated in up to twenty companies; and
p.(None): II - twenty-five percent of the sectorial production value, in the event that said production is concentrated in more than twenty companies.
p.(None): § 1 For the purposes of this article, the sectorial production value is the estimate of the national production value of the finished product or reproductive material
p.(None): arising from access to genetic heritage or associated traditional knowledge of unidentifiable origin as characterized in the reduction request.
p.(None): § 2 The request must be signed by the legal representatives of each of the signatories and will contain:
p.(None): I - documents proving the causal link between the material damage or its threat and the payment of the monetary benefit sharing corresponding to
p.(None): share of 1% (one percent) of annual net revenue; and
p.(None): II - characterization of the finished product or reproductive material for which the reduction of the 1% (one percent) portion provided for in art. 56.
p.(None): § 3 The characterization indicated in item II of § 2 will include the following information:
p.(None): I - accessed genetic heritage;
p.(None): II - associated traditional knowledge accessed;
p.(None): III - raw materials;
p.(None): IV - chemical composition;
p.(None): V - physical characteristics;
p.(None): VI - standards and technical specifications;
p.(None): VII - production process;
p.(None): VIII - uses and applications;
p.(None): IX - degree of substitutability; and
p.(None): X - distribution channels.
p.(None): § 4 The request will not be known if there is an ongoing verification covering the same or similar products.
p.(None): Art. 59. The conditions of art. 58, the Ministry of Environment:
p.(None): I - publish an act initiating the verification of material damage or its threat; and
p.(None): II - notify:
p.(None): a) interested companies;
p.(None): b) the Ministry of Development, Industry and Foreign Trade; and
p.(None): c) the bodies referred to in the sole paragraph of art. 21 of Law No. 13,123, of 2015.
p.(None): § 1 The act referred to in item I of the caput specifies the finished product or the reproductive material object of the verification and the signatory companies of the order.
p.(None): § 2 The manifestation of the Ministry of Development, Industry and Foreign Trade is a condition for the analysis referred to in art. 62 and will be presented within
p.(None): sixty days.
p.(None): § 3 The bodies referred to in item “c” of item II of the caput may manifest themselves within sixty days from the date of notification.
p.(None): Paragraph 4. A period of twenty days, counted from the date of publication of the act referred to in item I of the caput, will be granted for the submission of requests for
p.(None): other parties who consider themselves interested.
p.(None): Art. 60. The finding of material damage or its threat will be based on evidence and will include an objective examination of the effect of benefit sharing
p.(None): on the price of the product and the consequent impact on the productive sector.
p.(None): § 1 The examination referred to in the caput will include, among others, the evaluation of the following economic factors and indices:
p.(None): I - real or potential fall:
p.(None): a) sales;
p.(None): b) profits;
p.(None): c) production;
p.(None): d) market share;
p.(None): e) productivity; and
p.(None): f) the degree of utilization of installed capacity;
p.(None): II - actual or potential negative effects on:
p.(None): a) stocks;
p.(None): b) employment;
p.(None): c) wages; and
p.(None): d) growth of the productive sector;
p.(None): III - the contraction in demand or changes in consumption patterns;
p.(None): IV - competition between domestic and foreign producers; and
p.(None): V - export performance.
p.(None): § 2 For the purposes of the provisions of this article, the effects of the payment of the monetary benefit sharing corresponding to the 1% portion must be segregated.
p.(None): (one percent) of the annual net revenue from the effects arising from other causes that may have caused material damage or its threat.
p.(None): § 3 For the examination of the impact referred to in the caput, it will be considered whether the value of the benefit sharing had the effect of significantly depressing the
p.(None): sales.
p.(None): Art. 61. The Ministry of Development, Industry and Foreign Trade will make the analysis referred to in art. 60 and forward a technical opinion on the request for
p.(None): reduction of the benefit sharing amount to the Ministry of the Environment, within the period referred to in § 2 of art. 59.
p.(None): Art. 62. Received the opinion referred to in art. 61, the Ministry of the Environment will issue a technical opinion that should consider the content of the manifestations:
p.(None): I - the Ministry of Development, Industry and Foreign Trade; and
p.(None): II - the official bodies for the defense of the rights of indigenous peoples, traditional communities or traditional farmers, when presented.
p.(None): Paragraph 1 Interested companies will be notified to, within thirty days, comment on the opinion referred to in the caput.
p.(None): § 2 The Ministry of the Environment may accept the statements of interested companies, at which time it will issue a new opinion.
p.(None): Art. 63. The opinion will be submitted to the Minister of State for the Environment, who will decide, on a motivated basis, on the realization or not of the sectoral agreement.
p.(None): Art. 64. The terms of the sectoral agreement in force apply to all products produced in the national territory that fall under the terms of the decision, even
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None): a) one appointed by representatives of traditional peoples and communities and their organizations of the National Council of Traditional Peoples and Communities -
p.(None): CNPCT;
p.(None): b) one appointed by representatives of family farmers and their organizations from the National Council for Sustainable Rural Development - Condraf; and
p.(None): c) one nominated by representatives of indigenous peoples and organizations that are members of the National Council for Indigenous Policy - CNPI.
p.(None): § 1 CGen will be chaired by the senior adviser to the Ministry of the Environment and, in his impediments or absences, by the respective alternate.
p.(None): § 2 The representations referred to in this article shall consist of one holder and two alternates each, who will be appointed by the holder of the management bodies
p.(None): federal government and the respective legal representatives of civil society entities or organizations.
p.(None): § 3 The members of the CGen, members and alternates, will be appointed in an act of the Minister of State for the Environment, within thirty days of receiving the
p.(None): indications.
p.(None): § 4 The CGen Plenary will meet with the presence of at least eleven directors, and its decisions will be taken by a simple majority.
p.(None): Paragraph 5. The duties of the directors will not be remunerated and their exercise is considered a relevant public service, with the responsibility of public bodies and entities
p.(None): representatives of civil society defray the travel and subsistence expenses of their respective representatives.
p.(None): § 6 The Union will be responsible for defraying the travel and subsistence expenses of the members referred to in item IV of the caput.
p.(None): Section III
p.(None): Thematic Chambers and Sectorial Chambers
p.(None): Art. 8 Thematic Chambers will be created by CGen to support the decisions of the Plenary based on technical discussions and presentation of proposals on
p.(None): specific themes or areas of knowledge related to access and benefit sharing.
p.(None): § 1 The act of creating the Thematic Chambers will provide for their attributions, duration and composition, which must observe the proportion of:
p.(None): I - fifty percent of representatives of federal public administration bodies and entities with competences related to the subject of the respective Chamber;
p.(None): II - twenty-five percent of organizations representing the user sector; and
p.(None): III - twenty-five percent of organizations representing associated traditional knowledge providers.
p.(None): § 2 The CGen may create a special Thematic Chamber to analyze and support the Plenary's judgment of appeals filed as a last resort.
p.(None): Art. 9 The Sectorial Chambers will be created by CGen to support the decisions of the Plenary based on technical discussions and presentation of proposals for
p.(None): interest of the business and academic sectors, as well as of indigenous populations, traditional communities and traditional farmers.
p.(None): Single paragraph. The act of creation of the Sectorial Chambers will provide for their attributions, duration and composition, which must observe parity between
p.(None): representation of federal public administration bodies and entities with competences related to the respective Chamber and the civil society sector
p.(None): corresponding.
...
p.(None): end of the fiscal year in which there are:
p.(None): I - presentation of the benefit sharing agreement; or
p.(None): II - notification of finished product or reproductive material in cases where the benefit sharing is deposited directly with the FNRB, including exercises
p.(None): previous, if any.
p.(None): Paragraph 3. In the event of a sectoral agreement being concluded, the benefit sharing amount due as of the year of its entry into force will be calculated for the entire period.
p.(None): fiscal year, based on the defined rate.
p.(None): § 4 For the purposes of the provisions of § 8 of art. 17 of Law No. 13,123, of 2015, with no access to information on the product manufacturer's net revenue
p.(None): finished product or reproductive material produced outside of Brazil, the basis for calculating the benefit sharing will be the net revenue of the importer, subsidiary, subsidiary,
p.(None): affiliated, linked or commercial representative of the foreign producer in national territory or abroad.
p.(None): Section III
p.(None): Non-monetary Benefit Sharing
p.(None): Art. 50. The sharing of non-monetary benefits will be made through an agreement signed:
p.(None): I - with indigenous peoples, traditional communities and traditional farmers, providers of associated traditional knowledge of origin
p.(None): identifiable, in cases of economic exploitation of the finished product or reproductive material arising from this knowledge, negotiated in a fair and equitable manner
p.(None): between the parties, under the terms of art. 24 of Law No. 13,123, of 2015; or
p.(None): II - with the Union, in the case of economic exploitation of the finished product or reproductive material arising from access to genetic heritage.
p.(None): § 1 In the benefit sharing agreements implemented through the instruments referred to in items “a”, “e” and “f” of item II of art. 19, of Law nº
p.(None): 13,123, from 2015, the breakdown will be equivalent to seventy-five percent of the forecast for the monetary modality.
p.(None): § 2 In the benefit sharing agreements implemented by means of instruments not provided for in § 1, the allocation will be equivalent to the amount provided for
p.(None): the monetary modality.
p.(None): § 3 The project management expenses, including planning, and accountability, cannot be counted to achieve the percentage provided for in §§
p.(None): 1st and 2nd.
p.(None): § 4 For the purpose of proving the equivalence referred to in §§ 1 and 2, the user must present an estimate, based on market values.
p.(None): § 5 The benefit sharing agreements entered into by the Union will be implemented, preferably, through the instrument referred to in item “a”
p.(None): of item II of art. 19, of Law No. 13,123, of 2015.
p.(None): § 6 The user may not use non-monetary benefit sharing resources in marketing campaigns or any other form of advertising in
p.(None): benefit of your products, product lines or brands.
p.(None): Art. 51. In the case of item II of art. 50, the non-monetary benefit sharing referred to in items “a” and “e” of item II of art. 19 of Law No. 13,123, of
p.(None): 2015, will be aimed at:
p.(None): I - conservation units;
p.(None): II - indigenous lands;
p.(None): III - remaining quilombo territories;
p.(None): IV - rural settlement of family farmers;
p.(None): V - traditional territories under the terms of Decree No. 6,040, of February 7, 2007;
p.(None): VI - national public research and development institutions;
p.(None): VII - priority areas for conservation, sustainable use and benefit sharing of Brazilian biodiversity, as per the act of the Minister of State of
p.(None): Environment;
p.(None): VIII - activities related to the safeguarding of associated traditional knowledge;
p.(None): IX - ex situ collections maintained by accredited institutions under the terms of Chapter IV, Section V; and
p.(None): X - indigenous populations, traditional communities and traditional farmers.
p.(None): Art. 52. In the case of item II of art. 50 the sharing of non-monetary benefits referred to in points “b”, “c”, “d” and “f” of item II of art. 19 of Law nº
p.(None): 13,123, from 2015, will be destined to national public bodies and institutions that execute social interest programs.
...
Social / employees
Searching for indicator employees:
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p.(None): potential and, when feasible, assessing any threats to them;
p.(None): VIII - support for the efforts of indigenous populations, traditional communities and traditional farmers in sustainable management and conservation of
p.(None): genetic heritage;
p.(None): IX - conservation of wild plants;
p.(None): X - development of an efficient and sustainable ex situ and in situ conservation system and development and transfer of appropriate technologies for
p.(None): this purpose with a view to improving the sustainable use of genetic heritage;
p.(None): XI - monitoring and maintaining the viability, the degree of variation and the integrity of the genetic heritage maintained by collections;
p.(None): XII - adoption of measures to minimize or, if possible, eliminate threats to genetic heritage;
p.(None): XIII - development and maintenance of the various cultivation systems that favor the sustainable use of genetic heritage;
p.(None): XIV - elaboration and execution of Sustainable Development Plans for Traditional Populations or Communities; and
p.(None): XV - other actions related to access to genetic heritage and associated traditional knowledge, as defined by the FNRB Management Committee.
p.(None): § 1 The FNRB may support projects and training activities for the employees of the bodies and entities referred to in § 2 of art. 14.
p.(None): § 2 The FNRB may support projects and activities related to the elaboration of community protocols.
p.(None): Art. 101. FNRB resources must be used in the PNRB to support actions and activities that promote the objectives provided for in art. 100, through
p.(None): agreements, terms of partnership, collaboration or promotion, agreements, adjustments or other instruments of cooperation and transfer of resources provided for by law.
p.(None): Single paragraph. FNRB resources may also be allocated:
p.(None): I - the analysis, supervision, management and monitoring of supported actions, activities and projects;
p.(None): II - the remuneration and coverage of the expenses of the financial institution related to the administration of the Fund.
p.(None): Art. 102. The Ministry of the Environment will exercise the function of Executive Secretary of the FNRB Management Committee and will provide technical and administrative support
p.(None): necessary for the functioning of the FNRB and implementation of the PNRB.
p.(None): CHAPTER VIII
p.(None): TRANSITIONAL PROVISIONS ON FITNESS AND REGULARIZATION OF ACTIVITIES
p.(None): Art. 103. It shall conform to the terms of Law No. 13,123, of 2015, and of this Decree, within one year, counting from the date of the registration being made available by
p.(None): CGen, the user who performed, as of June 30, 2000, the following activities in accordance with Provisional Measure No. 2,186-16, of August 23, 2001:
p.(None): I - access to genetic heritage or associated traditional knowledge; and
...
Social / genetic heritage
Searching for indicator genetic heritage:
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p.(None): Presidency of the Republic
p.(None): General secretary
p.(None): Sub-branch for Legal Affairs
p.(None): DECREE No. 8.772, OF MAY 11, 2016
p.(None): Regulates Law No. 13,123, of May 20, 2015, which provides for access
p.(None): genetic heritage, protection and access to traditional knowledge
p.(None): and the sharing of benefits for conservation and sustainable use
p.(None): biodiversity.
p.(None): THE PRESIDENT OF THE REPUBLIC, using the powers conferred on her by art. 84, caput, item IV and item VI, item “a”, of the Constitution, and in view of the
p.(None): provided for in Law No. 13,123, of May 20, 2015,
p.(None): DECREE:
p.(None): CHAPTER I
p.(None): PRELIMINARY PROVISIONS
p.(None): Art. 1 This Decree regulates Law No. 13,123, of May 20, 2015, which provides for access to genetic heritage, protection and access to
p.(None): associated traditional knowledge and benefit sharing for conservation and sustainable use of biodiversity.
p.(None): § 1 The part of the genetic heritage existing in the national territory is considered, for the purposes of this Decree, the microorganism that has been isolated from
p.(None): substrates of the national territory, the territorial sea, the exclusive economic zone or the continental shelf.
p.(None): § 2 The microorganism will not be considered a national genetic heritage when the user, upon request by the competent authority, proves:
p.(None): I - that was isolated from substrates that are not from the national territory, the territorial sea, the exclusive economic zone or the continental shelf; and
p.(None): II - the regularity of its import.
p.(None): § 3 The plant and animal species introduced in the Country will only be considered genetic heritage found in conditions in situ in the national territory
p.(None): when they form spontaneous populations that have acquired their own distinctive characteristics in the country.
p.(None): § 4 The genetic heritage found in situ conditions is also considered to be the variety from a species introduced in the national territory with
p.(None): genetic diversity developed or adapted by indigenous populations, traditional communities or traditional farmers, including combined natural selection
p.(None): with human selection in the local environment, which is not substantially similar to commercial cultivars.
p.(None): Art. 2 The following activities are subject to the requirements of Law No. 13,123, 2015, and this Decree:
p.(None): I - access to genetic heritage or associated traditional knowledge;
p.(None): II - sending samples of genetic heritage abroad; and
p.(None): III - economic exploitation of finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge
p.(None): carried out after the entry into force of Law No. 13,123, of 2015.
p.(None): § 1 For the purposes of the provision in item II of the caput, the practice of any research or technological development activity that is carried out after 17
p.(None): November 2015, will be, regardless of the date of its beginning, considered as access made after the entry into force of Law No. 13,123, of 2015.
p.(None): § 2 The activities carried out between June 30, 2000 and November 17, 2015 must comply with the provisions of Chapter VIII of this Decree.
p.(None): Art. 3 The access to genetic heritage or associated traditional knowledge is not subject to the requirements of Law No. 13,123, 2015
p.(None): completed before June 30, 2000 and the economic exploitation of the finished product or reproductive material resulting therefrom.
p.(None): § 1 For the purposes of the caput, and when requested by the competent authority, the user must prove that all stages of access have ended
p.(None): before June 30, 2000.
p.(None): § 2 The proof referred to in § 1 must occur through:
p.(None): I - in the case of research:
p.(None): a) publication of an article in a scientific journal;
p.(None): b) communication at scientific events;
p.(None): c) filing a patent application;
p.(None): d) report of completion of the research with a public funding agency or entity; or
p.(None): e) publication of course completion papers, master's dissertations, doctoral theses; and
p.(None): II - in the case of technological development:
p.(None): a) filing a patent application;
p.(None): b) cultivar registration;
p.(None): c) product registration with public agencies; or
p.(None): d) proof of commercialization of the product.
p.(None): § 3 In the case of economic exploitation of finished product or reproductive material, in addition to the provisions of items I and II of § 2, the user must prove
p.(None): that the completed access was sufficient to obtain the finished product or reproductive material subject to economic exploitation.
p.(None): § 4 For the purposes of § 3, it is considered that the completed access was sufficient to obtain the finished product or reproductive material object of the exploration
p.(None): when there is no research or technological development activity after June 30, 2000.
p.(None): § 5 The Genetic Heritage Management Council may:
p.(None): I - define other means of proof in addition to those provided for in items I and II of § 2; and
p.(None): II - issue, upon request and proof, a document attesting to the user's qualification in the situations provided for in this article.
p.(None): CHAPTER II
p.(None): OF THE GENETIC HERITAGE MANAGEMENT COUNCIL - CGEN
p.(None): Section I
p.(None): General provisions
p.(None): Art. 4 The Genetic Heritage Management Council - CGen, a collegiate body of a deliberative, normative, advisory and appeal nature, has the following
p.(None): Skills:
p.(None): I - coordinate the development and implementation of policies for the management of access to genetic heritage and associated traditional knowledge and the
p.(None): benefit sharing;
p.(None): II - establish:
p.(None): a) technical standards;
p.(None): b) guidelines and criteria for drawing up and complying with the benefit-sharing agreement; and
p.(None): c) criteria for the creation of a database for recording information on genetic heritage and associated traditional knowledge;
p.(None): III - monitor, in conjunction with federal agencies, or through an agreement with other institutions, the activities of:
p.(None): a) access and shipment of a sample containing the genetic heritage; and
p.(None): b) access to associated traditional knowledge;
p.(None): IV - deliberate on:
p.(None): a) the accreditation of a national institution that maintains an ex situ collection of samples containing the genetic heritage; be them:
p.(None): 1. public; or
p.(None): 2. non-profit private companies that maintain popular herbariums or community seed banks; and
p.(None): b) the accreditation of a national public institution to be responsible for the creation and maintenance of the database referred to in item X;
p.(None): V - certify the regularity of access to genetic heritage or associated traditional knowledge referred to in Chapter IV of Law No. 13,123, of 2015;
p.(None): VI - record 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.
p.(None): 16 of Law No. 13,123, of 2015;
p.(None): VII - promote public debates and consultations on the topics covered by Law No. 13,123, of 2015;
p.(None): VIII - to function as a higher level of appeal in relation to the decision of an accredited institution and the acts resulting from the application of Law No. 13,123, of 2015
p.(None): ;
p.(None): IX - establish guidelines for the application of the resources destined to the National Fund for the Sharing of Benefits - FNRB, by way of sharing of
p.(None): benefits;
p.(None): X - create and maintain a relative database:
p.(None): a) records of access to genetic heritage or associated traditional and referral knowledge;
p.(None): b) authorizations for access to genetic heritage or associated traditional and referral knowledge;
p.(None): c) instruments and material transfer terms for sending samples and shipments;
p.(None): d) the ex situ collections of accredited institutions that contain samples of genetic heritage;
p.(None): e) notifications of finished product or reproductive material;
p.(None): f) benefit sharing agreements; and
p.(None): g) certificates of regularity of access;
p.(None): XI - scienti fi c federal agencies to protect the rights of indigenous populations, traditional communities and traditional farmers on registration in
p.(None): registration of access to associated traditional knowledge; and
p.(None): XII - approve its internal regulations, which shall provide, at least, about:
p.(None): a) organization and functioning of its meetings;
p.(None): b) functioning of the Executive Secretariat;
p.(None): c) procedure for the appointment of its Directors;
p.(None): d) removal, impediment, suspicion and hypotheses of conflict of interests of the Directors;
p.(None): e) publicizing its technical standards and resolutions; and
p.(None): f) composition and functioning of the Thematic and Sectorial Chambers.
p.(None): Single paragraph. CGen may, at the user's request, issue an internationally recognized certificate of compliance that will serve as proof that
p.(None): activities on genetic heritage or associated traditional knowledge were carried out in accordance with Law No. 13,123 of 2015 and this Decree.
p.(None): Art. 5 Without prejudice to the System provided for in Chapter IV of this Decree, CGen shall maintain its own system for traceability of activities resulting from
p.(None): access to genetic heritage or associated traditional knowledge, including those related to economic exploitation.
p.(None): § 1 Under the terms of art. 7 of Law No. 13,123 of 2015, the system provided for in the caput will be managed by the Executive Secretariat of CGen and will have the
p.(None): information necessary for the traceability of activities resulting from access to genetic heritage or associated traditional knowledge
p.(None): systems databases:
p.(None): I - protection and registration of cultivars, seeds and seedlings, agricultural products, establishments and inputs, traffic information
p.(None): international agricultural products and inputs from the Ministry of Agriculture, Livestock and Supply;
p.(None): II - import and export registration under the Integrated Foreign Trade System - Siscomex, instituted by Decree No. 660, of September 25,
p.(None): 1992;
p.(None): III - information on curricula, research groups, institutions registered on the Lattes Platform of the National Council for Scientific Development and
p.(None): Technological - CNPq;
p.(None): IV - information on research and commercial release of genetically modified organisms and derivatives, from the National Technical Commission for
p.(None): Biosafety - CTNBio from the Ministry of Science, Technology and Innovation;
p.(None): V - registration of products from the National Health Surveillance Agency - Anvisa;
p.(None): VI - granting and guaranteeing intellectual property rights of the National Institute of Industrial Property - INPI;
p.(None): VII - national register of social information of the Ministry of Social Development and Fight against Hunger; and
p.(None): VIII - information on cultural heritage of the National Information and Cultural Indicators System - SNIIC, of the Ministry of Culture.
p.(None): § 2 The bodies and entities referred to in this article shall adopt the necessary measures to guarantee access to information through the traceability system and the
p.(None): Ministry of the Environment will adopt the necessary measures for the integration of the information contained in the databases provided for in § 1.
p.(None): § 3 In the impossibility of adopting the measures provided for in § 2, the information must be forwarded to CGen within thirty days, counted from the
p.(None): solicitation.
p.(None): § 4 CGen may also:
p.(None): I - request additional information from the bodies and entities provided for in § 1;
p.(None): II - to request other organs and entities of the federal public administration information that it deems necessary for the traceability of activities
p.(None): arising from access to genetic heritage or associated traditional knowledge; and
p.(None): III - adopt measures to guarantee access to information through the traceability system and the integration of databases with different bodies and entities
p.(None): those provided for in items I to VIII of §1 of the caput.
p.(None): § 5 The bodies and entities of the federal public administration that provide confidential information to CGen shall indicate this circumstance
p.(None): express, specifying, when applicable, the classification of the information regarding the degree and term of confidentiality, in accordance with the provisions of Law No. 12,527, of November 18,
p.(None): 2011, or in specific legislation.
p.(None): § 6 The Executive Secretariat of CGen will ensure the legal confidentiality of information, respecting the classification of information regarding the degree and term of confidentiality,
p.(None): When it's the case.
p.(None): § 7 For the purposes of the caput, CGen may have access to the data contained in systems of the Secretariat of the Federal Revenue of Brazil contained in
p.(None): public domain registration and that do not inform the taxpayers' economic or financial situation.
p.(None): Art. 6 CGen will operate through:
p.(None): I - Plenary;
p.(None): II - Thematic Chambers;
p.(None): III - Sectorial Chambers; and
p.(None): IV - Executive Secretariat.
p.(None): Section II
p.(None): From the Plenary
p.(None): Article 7. The CGen Plenary will be composed of twenty-one members, twelve representatives of federal public administration bodies and nine
p.(None): representatives of civil society, distributed as follows:
p.(None): I - one representative from each of the following ministries:
p.(None): a) Ministry of the Environment;
p.(None): b) Ministry of Justice;
...
p.(None): § 2 The CGen may create a special Thematic Chamber to analyze and support the Plenary's judgment of appeals filed as a last resort.
p.(None): Art. 9 The Sectorial Chambers will be created by CGen to support the decisions of the Plenary based on technical discussions and presentation of proposals for
p.(None): interest of the business and academic sectors, as well as of indigenous populations, traditional communities and traditional farmers.
p.(None): Single paragraph. The act of creation of the Sectorial Chambers will provide for their attributions, duration and composition, which must observe parity between
p.(None): representation of federal public administration bodies and entities with competences related to the respective Chamber and the civil society sector
p.(None): corresponding.
p.(None): Art. 10. The members of the Thematic Chambers and the Sectorial Chambers will be appointed by the members of the Plenary of CGen, considering the formation, the
p.(None): performance or notorious knowledge in the area related to the Chamber's competences.
p.(None): Section IV
p.(None): The Executive Secretariat
p.(None): Art. 11. The Executive Secretariat of CGen is responsible for:
p.(None): I - provide technical and administrative support to the Plenary of CGen and its Chambers;
p.(None): II - promote the instruction and processing of the processes to be submitted to CGen's decision;
p.(None): III - issue, in accordance with the resolution of CGen, the acts and decisions within its competence;
p.(None): IV - promote, in accordance with CGen's resolution, the accreditation or disqualification of:
p.(None): a) a national institution that maintains an ex situ collection of samples containing the genetic heritage; and
p.(None): b) national public institution to be responsible for the creation and maintenance of a database dealing with the item listed in items of item IX of § 1
p.(None): of art. 6 of Law No. 13,123, of 2015; and
p.(None): V - implement, maintain and operate the systems:
p.(None): a) traceability of information related to genetic heritage and associated traditional knowledge, provided for in art. 5th; and
p.(None): b) covered by Chapter IV of this Decree.
p.(None): CHAPTER III
p.(None): OF ASSOCIATED TRADITIONAL KNOWLEDGE
p.(None): Art. 12. The right to participation of indigenous populations, traditional communities and traditional farmers who create, develop, own or
p.(None): retain traditional associated knowledge in the decision-making process on issues related to access to associated traditional knowledge and
p.(None): benefit sharing resulting from that access.
p.(None): § 1 Access to associated traditional knowledge of identifiable origin is subject to obtaining prior informed consent.
p.(None): § 2 Access to associated traditional knowledge of non-identifiable origin does not depend on prior informed consent.
p.(None): § 3 Any indigenous population, traditional community or traditional farmer who creates, develops, holds or retains certain knowledge
p.(None): associated traditional is considered an identifiable source of this knowledge, except in the hypothesis of § 3 of art. 9 of Law No. 13,123, of 2015.
p.(None): Art. 13. The indigenous population, traditional community or traditional farmer may deny consent to access their associated traditional knowledge
p.(None): of identifiable origin.
...
p.(None): the prior consent process.
p.(None): Art. 17. Subject to the guidelines referred to in art. 16, the instrument of proof of obtaining prior informed consent will be formalized in
p.(None): language accessible to the indigenous population, the traditional community and the traditional farmer and will contain:
p.(None): I - description of the history of the process for obtaining prior informed consent;
p.(None): II - the description of the traditional forms of organization and representation of the indigenous population, traditional community or traditional farmer;
p.(None): III - the objective of the research, as well as its methodology, duration, budget, possible benefits and sources of financing for the project;
p.(None): IV - the intended use of the associated traditional knowledge to be accessed; and
p.(None): V - the geographical area covered by the project and the indigenous populations, traditional communities or traditional farmers involved.
p.(None): Single paragraph. The instrument referred to in the caput must also expressly mention whether the indigenous population, the traditional community or the farmer
p.(None): traditional group received technical or legal advice during the process of obtaining prior informed consent.
p.(None): Art. 18. Access to the genetic heritage of the local or Creole traditional variety or to the locally adapted or Creole breed for agricultural activities comprises
p.(None): access to associated traditional knowledge of non-identifiable origin that gave rise to the variety or race and does not depend on prior consent from the
p.(None): indigenous population, traditional community or traditional farmer who creates, develops, owns or preserves the variety or breed.
p.(None): § 1 Under the terms of item XXIV of art. 2 of Law No. 13,123, of 2015, the activities of production, processing and
p.(None): commercialization of food, beverages, fibers, energy and planted forests.
p.(None): § 2 The biofuels, such as ethanol, biodiesel, biogas and cogeneration of electric energy from
p.(None): biomass processing.
p.(None): § 3 For activities that do not fit the concept of agricultural activity, access to the genetic heritage of a traditional local or Creole variety or to
p.(None): locally adapted or creole breed comprises the associated traditional knowledge that gave rise to the variety or breed, and will follow the rules of access to
p.(None): associated traditional knowledge set out in Law No. 13,123 of 2015 and in this Decree.
p.(None): § 4 In the case of access to the genetic heritage of a traditional local or creole variety referred to in the caput, the user must deposit reproductive material
p.(None): of the variety subject to access in an ex situ collection maintained by a public institution, except when the variety was obtained from the collection itself.
p.(None): Art. 19. Indigenous populations, traditional communities and traditional farmers who create, develop, hold or retain knowledge
p.(None): associated traditional rights are guaranteed to use or freely sell products containing genetic heritage or associated traditional knowledge,
p.(None): subject to the provisions of Law No. 9,456, of April 25, 1997, and Law No. 10,711, of August 5, 2003.
p.(None): Paragraph 1. Anvisa, within the scope of the powers referred to in Law No. 9,782, of January 26, 1999, will regulate the production and sale of products to
p.(None): referred to in the caput.
p.(None): § 2 The regulation provided for in § 1 must establish simplified procedures and will include the participation of indigenous populations, communities
p.(None): traditional farmers and traditional farmers, considering their uses, customs, and traditions.
p.(None): CHAPTER IV
p.(None): NATIONAL GENETIC HERITAGE AND KNOWLEDGE MANAGEMENT SYSTEM
p.(None): TRADITIONAL ASSOCIATE - SISGEN
p.(None): Section I
p.(None): General provisions
p.(None): Art. 20. The National System for the Management of Genetic Heritage and Associated Traditional Knowledge - SisGen is created, an electronic system to be implemented,
p.(None): maintained and operated by the CGen Executive Secretariat for management:
p.(None): I - the register of access to genetic heritage or associated traditional knowledge, as well as the register for sending a sample containing
p.(None): genetic heritage to provide services abroad;
p.(None): II - the record of sending a sample of genetic heritage and the Material Transfer Term;
p.(None): III - authorizations for access to genetic heritage or associated traditional knowledge and remittance abroad, in the cases referred to in art. 13
p.(None): of Law No. 13,123, of 2015;
p.(None): IV - the accreditation of the institutions that maintain the ex situ collections that contain samples of genetic heritage;
p.(None): V - notifications of finished product or reproductive material and benefit sharing agreements; and
p.(None): VI - certificates of regularity of access.
p.(None): § 1 The registration must be carried out in advance:
p.(None): I - the shipment;
p.(None): II - the application for any intellectual property right;
p.(None): III - the commercialization of the intermediate product;
p.(None): IV - the dissemination of results, final or partial, in scientific or communication media; or
p.(None): V - notification of finished product or reproductive material developed as a result of access.
p.(None): § 2 If there are changes in fact or in law in the information provided to SisGen, the user must update his records or noti fi cation,
p.(None): at least once a year.
p.(None): § 3 The update referred to in § 2 must also be carried out to include information regarding the application for any intellectual property right
p.(None): or patent licensing.
p.(None): Art. 21. The information contained in the SisGen is public, except for those that, upon user's request, are considered confidential.
p.(None): Single paragraph. The request referred to in the caput must indicate the relevant legal basis and be accompanied by a non-confidential summary.
p.(None): Section II
p.(None): The register of access to genetic heritage or associated traditional knowledge and the register
p.(None): sending a sample containing genetic heritage to provide services abroad
p.(None): Art. 22. For the registration of access to genetic heritage or associated traditional knowledge, the natural or legal person must
p.(None): complete the electronic SisGen form which will require:
p.(None): I - user identification;
p.(None): II - information on research or technological development activities, including:
p.(None): a) summary of the activity and its respective objectives;
p.(None): b) application sector, in the case of technological development;
p.(None): c) expected or obtained results, depending on the moment of registration;
p.(None): d) responsible team, including partner institutions, if any;
p.(None): e) period of activities;
p.(None): f) identification of genetic heritage at the strictest possible taxonomic level or associated traditional knowledge, as the case may be, in particular:
p.(None): 1. the origin of the genetic heritage, including georeferenced coordinate in the degree, minute and second format, of the place of obtaining in situ, even if
p.(None): have been obtained from ex situ or in silico sources; and
p.(None): 2. of the indigenous population, traditional community or traditional farmer who provide the associated traditional knowledge, even if the knowledge
p.(None): have been obtained from secondary sources;
p.(None): g) declaration if the genetic heritage is a traditional local or creole variety or a locally adapted or creole breed, or if the species is on an official list of
p.(None): endangered species;
p.(None): h) information from the institution based abroad associated with the national institution, in the case provided for in item II of art. 12 of Law No. 13,123, of 2015; and
p.(None): i) identification of partner national institutions, if any;
p.(None): III - previous registration or authorization number, in the case of genetic heritage or associated traditional knowledge accessed from research or
p.(None): technological development carried out after June 30, 2000;
p.(None): IV - proof of obtaining prior informed consent pursuant to art. 9 of Law No. 13,123, of 2015, and of art. 17 of this Decree, when applicable;
p.(None): V - request for recognition of legal secrecy hypothesis; and
p.(None): VI - declaration, as the case may be, of classification in the event of legal exemption or non-incidence of benefit sharing.
p.(None): Paragraph 1 When it is not possible to identify the georeferenced coordinate of the on-site location referred to in item 1 of item “f” of item II of the caput, and
p.(None): only in cases in which the genetic heritage was obtained on a date prior to the entry into force of Law No. 13,123, of 2015, the provenance may be
p.(None): informed based on the most specific geographical location possible, in one of the following ways:
p.(None): I - identification of the source of obtaining ex situ genetic heritage, with the information contained in the deposit record, when it comes from ex collection
p.(None): situ; or
p.(None): II - identification of the genetic heritage source database with the information contained in the deposit record, when it comes from
p.(None): data in silico.
p.(None): § 2 The registration of access to associated traditional knowledge must:
p.(None): I - identify the sources of obtaining the associated traditional knowledge; and
p.(None): II - inform the georeferenced coordinate of the respective community, except when dealing with associated traditional knowledge of non-identifiable origin.
p.(None): Paragraph 3. If it is not possible to inform the georeferenced coordinates referred to in item II of Paragraph 2, the user must inform the geographical location more
p.(None): possible.
p.(None): § 4º CGen will define in technical standard:
p.(None): I - the strictest taxonomic level to be informed, in research cases with the objective of evaluating or elucidating the genetic diversity or the evolutionary history of
p.(None): a taxonomic species or group;
p.(None): II - how to indicate the most specific geographic location possible, in cases where access is exclusively for research purposes in which they are
p.(None): more than one hundred records of origin are required per registration; and
p.(None): III - how to indicate the genetic heritage, in cases of access from samples of substrates containing non-isolated microorganisms.
p.(None): § 5 The user must perform a new registration when there is a change in the genetic heritage or associated traditional knowledge accessed or the objective
p.(None): access.
p.(None): Art. 23. After completing the form referred to in art. 22 SisGen will automatically issue proof of access registration.
p.(None): § 1 The proof of access registration constitutes a suitable document to demonstrate that the user provided the information that was required and produces the
p.(None): following effects:
p.(None): I - allows, under the terms of § 2 of art. 12 of Law No. 13,123, of 2015:
p.(None): a) the application for any property and intellectual rights;
p.(None): b) the commercialization of an intermediate product;
p.(None): c) the dissemination of the results, final or partial, of research or technological development, in scientific or communication media; and
p.(None): d) notification of finished product or reproductive material developed as a result of access; and
p.(None): II - establishes the start of the verification procedure provided for in Section VII of this Chapter.
p.(None): § 2º The user will not need to wait for the verification procedure to finish to carry out the activities referred to in item I of § 1.
p.(None): Art. 24. Sisgen will provide an electronic form in the access register so that the national legal entity, public or private, registers the sending of a sample
p.(None): that contains genetic heritage for the provision of services abroad as part of research or technological development.
p.(None): § 1 The national legal entity, public or private, may authorize the natural person responsible for technological research or development to complete the
p.(None): shipping register.
p.(None): § 2 The registration register referred to in the caput will require:
p.(None): I - information about the recipient institution abroad, including contact information and indication of legal representative; and
p.(None): II - information of the samples to be sent, containing the identification of the genetic heritage to be sent.
p.(None): § 3 The sending of a sample containing genetic heritage for the provision of services abroad, under the terms of item XXX of art. 2 of Law No. 13,123, of
p.(None): 2015, does not result in a transfer of responsibility for the sample of the institution responsible for sending it to the recipient institution.
p.(None): § 4 For the purposes of § 3, the provision of services abroad is the execution of tests or specialized technical activities performed by
p.(None): partner institution of the national institution responsible for access or contracted by it, in return or consideration.
p.(None): Paragraph 5. The consideration or consideration provided for in Paragraph 4 may be waived when the partner institution integrates the research as a co-author, subject to the provisions
p.(None): in § 6.
p.(None): § 6 The legal instrument signed between the national institution responsible for access and the partner or contracted institution must contain:
p.(None): I - identification of genetic heritage at the strictest possible taxonomic level, subject to the provisions of § 4 of art. 22;
p.(None): II - information on:
p.(None): a) the type of sample and the form of packaging; and
p.(None): b) the number of containers, the volume or the weight;
p.(None): III - description of the specialized technical service object of the provision;
p.(None): IV - obligation to return or destroy the samples sent;
p.(None): V - breakdown of the term for the provision of services, detailing by activity to be performed, when applicable; and
p.(None): VI - clauses prohibiting the partner institution or contractor from:
p.(None): a) pass on the sample of the genetic heritage or the information of genetic origin of the species to be sent, including substances from the metabolism
p.(None): these beings to third parties;
p.(None): b) use the sample of genetic heritage or information of genetic origin of the species to be sent for any purpose other than those provided for;
p.(None): c) economically exploit intermediate or finished product or reproductive material resulting from access; and
p.(None): d) request any type of intellectual property right.
p.(None): § 7 The legal instrument referred to in § 6 will not be mandatory in cases of sending a sample for genetic sequencing.
p.(None): § 8 In the case of § 7, the user must formally communicate to the partner or contracted institution the obligations provided for in items IV and VI of § 6.
p.(None): § 9 The registration of sample submission must be carried out within the deadlines defined for the access registration.
p.(None): § 10. The samples to be sent must be accompanied by:
p.(None): I - the legal instrument referred to in § 6; and
p.(None): II - prior informed consent, in case of sending a sample of genetic heritage of a traditional local or creole variety or locally adapted breed
p.(None): or Creole for access in non-agricultural activities, when applicable.
p.(None): Section III
p.(None): From the record of sending a sample of genetic heritage and the Material Transfer Term
p.(None): Art. 25. In order to register the shipment of a sample of genetic heritage, the natural or legal person must complete the form
p.(None): electronic SisGen that will require:
p.(None): I - identification:
p.(None): a) the sender;
p.(None): b) samples of genetic heritage at the strictest possible taxonomic level; and
p.(None): c) the origin of the samples to be sent, observing the provisions of item 1 of item “f” of item II, in § 1 and in item II of § 4 of art. 22;
p.(None): II - information on:
p.(None): a) the type of sample and the form of packaging;
p.(None): b) the number of containers, the volume or the weight;
p.(None): c) the recipient institution abroad, including indication of legal representative and contact information; and
p.(None): d) access activities abroad, including objectives, intended uses and application sector of the research or technological development project;
p.(None): III - Material Transfer Term - TTM, signed between the natural or legal person in Brazil and the legal entity headquartered abroad; and
p.(None): IV - prior informed consent that expressly authorizes the shipment in the case of genetic heritage of a traditional local or creole variety or breed
p.(None): locally adapted or Creole for access in non-agricultural activities, when applicable.
p.(None): § 1 The TTM referred to in item III of the caput must contain:
p.(None): I - the information referred to in items I and II of the caput of this article;
p.(None): II - the obligation to comply with the requirements of Law No. 13,123, of 2015;
p.(None): III - the forecast that:
p.(None): a) the TTM must be interpreted in accordance with Brazilian laws, and, in the event of a dispute, the competent forum is that of Brazil, admitting arbitration agreed between
p.(None): the parts.
p.(None): b) the institution receiving the genetic heritage will not be considered a provider of the genetic heritage; and
p.(None): c) the recipient institution will require a third party to sign a TTM with the obligation to comply with the requirements of Law No. 13,123, 2015, including the
p.(None): provision of line “a” of this item;
p.(None): IV- clause that authorizes or prohibits the transfer of the sample to third parties; and
p.(None): V - information on access to associated traditional knowledge, when applicable.
p.(None): § 2 In the event of authorization referred to in item IV of § 1, the transfer of the sample to third parties will also depend on the signature of the TTM that contains the
p.(None): clauses provided for in § 1.
p.(None): § 3 The provisions of § 2 apply to all subsequent transfers.
p.(None): Art. 26. After completing the form referred to in art. 25 SisGen will automatically issue proof of shipment registration.
p.(None): § 1 The proof of shipment registration constitutes a suitable document to demonstrate that the user provided the information that was required and produces the
p.(None): following effects:
p.(None): I - allows the remittance to take place, under the terms of § 2 of art. 12 of Law No. 13,123, of 2015; and
p.(None): II - establishes the start of the verification procedure provided for in Section VII of this Chapter.
p.(None): § 2 For the purposes of item I of § 1, in addition to the proof of shipment registration, samples must be accompanied by the respective TTM
p.(None): to be sent regularly.
p.(None): § 3 The user will not need to wait for the verification procedure referred to in item II of § 1 to complete before making the shipment.
p.(None): Section IV
p.(None): Authorizations for access to genetic heritage and associated traditional knowledge and
p.(None): remittance abroad, for the cases referred to in art. 13 of Law No. 13,123, of 2015
p.(None): Art. 27. In cases of access to genetic heritage or associated traditional knowledge in areas essential to national security, in waters
p.(None): Brazilian jurisdictions, on the continental shelf and in the exclusive economic zone, access or remittance will be subject to the prior authorization referred to in art. 13 da
p.(None): Law No. 13,123, of 2015, when the user is:
p.(None): I - national legal person, whose controlling shareholders or partners are natural or foreign legal persons;
p.(None): II - national scientific and technological research institution, public or private, when access is made in association with a legal entity based in the
p.(None): outside; or
p.(None): III - Brazilian natural person associated, financed or contracted by a legal entity headquartered abroad.
p.(None): § 1 For the purposes of the caput, the border strip and the oceanic islands are considered essential areas for national security.
p.(None): § 2 The user must, prior to accessing the genetic heritage or associated traditional knowledge, fill in all the information in the
p.(None): access or remittance provided for in arts. 22 and 25, as well as identifying the corporate structure of the company and the associated legal entity, as appropriate.
p.(None): § 3 In the event that the corporate structure is composed of other legal entities, the user must identify the respective corporate structures, until
p.(None): individuals who have the status of partner or controller are identified.
p.(None): § 4 Access and remittance authorizations can be requested together or separately.
p.(None): § 5 The filling in of the access and remittance registration information includes the automatic request for prior authorization and consent by the Council
p.(None): National Defense or Navy Command, as appropriate.
p.(None): § 6 The national institution referred to in item II of the caput that makes several accesses in association with the same foreign legal entity may receive a
p.(None): only authorization for all accesses.
p.(None): § 7 The registration of access and remittance will not be completed until the consent of the National Defense Council or the Navy Command is obtained.
p.(None): Art. 28. After providing the information, SisGen, within five days, will notify the Executive Secretariat of the National Defense Council or the Command of
p.(None): Navy, which must manifest itself within sixty days, considering the national interest.
p.(None): § 1 The request for additional information or documents by the National Defense Council or Navy Command will suspend the term for its
p.(None): manifestation until the effective delivery of what was requested.
p.(None): § 2 The provisions of this Section do not suspend the terms of the administrative verification procedure referred to in Section VII of this Chapter.
p.(None): Art. 29. After obtaining the consent of the National Defense Council or the Navy Command, access or remittance is automatically authorized.
p.(None): § 1 The changes in the corporate structure or in the controlling interest that occurred after obtaining the consent must be informed to SisGen, within thirty
p.(None): days.
p.(None): § 2 The National Defense Council or the Navy Command may, in a reasoned decision, revoke the consent previously granted.
p.(None): § 3 In the hypothesis foreseen in § 2 the user will have a period of thirty days to present his defense.
p.(None): § 4 If the user's arguments are not accepted, the National Defense Council or the Navy Command will revoke the consent and communicate CGen to
p.(None): to cancel the registration of access or remittance.
p.(None): Section V
p.(None): Accreditation of national institutions that maintain collections
p.(None): x situ of samples containing the genetic heritage
p.(None): Art. 30. The accreditation of a national institution that maintains an ex situ collection of samples containing genetic heritage aims to bring together the
p.(None): information necessary for the creation of the database referred to in item “d” of item IX of § 1 of art. 6 of Law No. 13,123, of 2015, in order to guarantee access to
p.(None): strategic information on the ex situ conservation of genetic heritage in the national territory.
p.(None): § 1 In accordance with the provisions of § 2 of art. 32 of Law No. 13,123, of 2015, only the national institution that maintains
p.(None): ex situ collections that are accredited under this Section.
p.(None): § 2 Private non-profit institutions that maintain popular herbaria or community seed banks may be accredited as
p.(None): national institutions that maintain ex situ collections as long as they observe the provisions of this Section.
p.(None): § 3 The criteria for receiving the resources referred to in this article will be defined by the FNRB Management Committee.
p.(None): Art. 31. For the accreditation of a national institution that maintains an ex situ collection of samples containing genetic heritage, the legal entity must
p.(None): fill out an electronic form at SisGen, which will require:
p.(None): I - identification of the institution; and
p.(None): II - information on each of the ex situ collections including:
p.(None): a) identification of curators or guardians;
p.(None): b) types of preserved samples;
p.(None): c) collected taxonomic groups; and
p.(None): d) method of storage and conservation.
p.(None): § 1 Completed the completion of the form by the legal entity, CGen, under the terms of art. 6, § 1, item III, item “b”, of Law No. 13,123, of
p.(None): 2015, will decide on the accreditation referred to in the caput.
p.(None): § 2 The national institution must keep updated the information dealt with in items I and II of the caput.
p.(None): Art. 32. Samples of genetic heritage maintained in ex situ collections in national institutions managed with public resources and the information to them
p.(None): associated areas can be accessed by indigenous peoples, traditional communities and traditional farmers.
p.(None): § 1 The institution that receives the request must, within a period not exceeding twenty days:
p.(None): I - communicate the date, place and method of making the genetic heritage available;
p.(None): II - indicate the reasons for the impossibility, totally or partially, of fulfilling the request; or
p.(None): III - communicate that he does not have the genetic heritage.
p.(None): § 2 The term referred to in § 1 may be extended for another ten days, upon express justification, of which the applicant will be informed.
p.(None): § 3 The amount necessary to reimburse costs for the regeneration or multiplication of samples or availability may be charged exclusively
p.(None): information on genetic heritage.
p.(None): § 4 The provision of a sample must be free of charge when made by national institutions that maintain an ex situ collection that receive funds from the
p.(None): FNRB.
p.(None): Section VI
p.(None): Notifications of finished product or reproductive material and benefit-sharing agreements
p.(None): Art. 33. The user must notify the finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge
p.(None): carried out after the validity of Law No. 13,123, of 2015.
p.(None): § 1 The notification referred to in the caput must be made before the beginning of the economic exploration.
p.(None): § 2 For the purposes of paragraph 1, economic exploration is considered to have started when the first fiscal note for the sale of the finished product is issued or
p.(None): reproductive material.
p.(None): Art. 34. For the notification of the finished product or reproductive material arising from access to genetic heritage or traditional knowledge
p.(None): associated, the user must fill in the electronic form of SisGen, which will require:
p.(None): I - identification of the requesting natural or legal person;
p.(None): II - commercial identification of the finished product or reproductive material and application sector;
p.(None): III - information if the genetic heritage or the associated traditional knowledge used in the finished product is decisive for the formation of the appeal
p.(None): marketing;
p.(None): IV - information on whether the genetic heritage or the associated traditional knowledge used in the finished product is decisive for the existence of
p.(None): functional characteristics;
p.(None): V - forecast of the local, regional, national or international scope of the manufacture and commercialization of the finished product or reproductive material;
p.(None): VI - registration number, or equivalent, of a product or cultivar in a competent organ or entity, such as Anvisa, Ministry of Agriculture, Livestock and
p.(None): Supply and the Brazilian Institute for the Environment and Renewable Natural Resources - Ibama;
p.(None): VII - number of the deposit for requesting intellectual property rights for a product or cultivar at the Ministry of Agriculture, Livestock and Supply or at the INPI,
p.(None): or in offices abroad, if any;
p.(None): VIII - estimated date for the start of commercialization;
p.(None): IX - indication of the type of benefit sharing;
p.(None): X - presentation of a benefit sharing agreement, when applicable;
p.(None): XI - numbers of the records of access to genetic heritage or associated traditional knowledge that gave rise to the finished product or material
p.(None): reproductive system, subject to the provisions of art. 2 and in Chapter VIII of this Decree;
p.(None): XII - numbers of the shipping records that gave rise to the finished product or reproductive material, if any;
p.(None): XIII - request for recognition of legal secrecy hypothesis; and
p.(None): XIV - proof of compliance in the event of legal exemption or non-incidence of benefit sharing.
p.(None): Single paragraph. The benefit-sharing agreement must be submitted:
p.(None): I - at the time of notification, in the case of access to associated traditional knowledge of identifiable origin; or
p.(None): II - within three hundred and sixty-five days from the notification of the finished product or reproductive material.
p.(None): Art. 35. After completing the form referred to in art. 34 SisGen will automatically issue proof of notification.
p.(None): § 1 The proof of notification constitutes a suitable document to demonstrate that the user provided the information that was required and produces the following
p.(None): effects:
p.(None): I - allows the economic exploitation of the finished product or reproductive material, subject to the provisions of art. 16 of Law No. 13,123, of 2015; and
p.(None): II - establishes the start of the verification procedure provided for in Section VII of this Chapter.
p.(None): § 2 The user will not need to wait for the verification procedure referred to in item II of § 1 to finish before starting the economic exploration.
p.(None): Section VII
p.(None): The administrative verification procedure
p.(None): Art. 36. The administrative verification procedure provided for in this Section will be applied in cases of:
p.(None): I - registration of access to genetic heritage or associated traditional knowledge referred to in Section II of this Chapter;
p.(None): II - registration of the shipment of a sample of genetic heritage, referred to in Section III of this Chapter; and
p.(None): III - notification of finished product or reproductive material referred to in Section VI of this Chapter.
p.(None): Art. 37. During the verification period, the CGen Executive Secretariat:
p.(None): I - inform CGen's councilors about the registration or notification;
p.(None): II - forward to the members of the competent sectorial chambers the information related to the species subject to access and the Municipality of its location, according to
p.(None): dissociated form from the respective registers and other information contained therein;
p.(None): III - scientific, under the terms of item X of art. 6 of Law No. 13,123, 2015, federal bodies for the protection of the rights of indigenous populations and communities
p.(None): about registration in the registry for access to associated traditional knowledge; and
p.(None): IV - it will be able to identify, by letter, any irregularities in the registration or notification process, when it will request the ratification of the information
p.(None): or rectify formal errors.
p.(None): § 1 The provisions of the caput must be made by the Executive Secretariat of CGen within the term:
p.(None): I - fifteen days, in relation to items I, II and III; and
p.(None): II - sixty days, in relation to item IV.
p.(None): § 2 CGen's directors will have access to all available information, including those considered confidential, and will not be able to disclose it, under penalty of
p.(None): accountability, under the terms of the legislation.
p.(None): § 3 In cases of manifest fraud, the President of the CGen may cautiously suspend the registrations and the ad referendum notification of the Plenary.
p.(None): § 4 In the event of § 3, the cautionary decision will be forwarded for deliberation at the next plenary session.
p.(None): Art. 38. CGen's directors may identify signs of irregularity in the information contained in the records and the notification within sixty
p.(None): days from the date of the acknowledgment referred to in item I of the caput of art. 37.
p.(None): § 1 The board members may, within the term referred to in the caput, receive subsidies:
p.(None): I - the sectoral chambers;
p.(None): II - the bodies referred to in item III of the caput of art. 37;
p.(None): III - CGen's Executive Secretariat; and
p.(None): IV - directly from holders of associated traditional knowledge or their representatives.
p.(None): Paragraph 2. In the event of the caput, the board member shall submit a request for verification of evidence of irregularity duly justified for the resolution of the
p.(None): CGen plenary session.
p.(None): § 3 In agricultural activities, the fact that the species is domesticated cannot be considered, on its own, as a basis for evidence of irregularity in the register
p.(None): of access to genetic heritage on the grounds of access to associated traditional knowledge.
p.(None): Art. 39. The CGen Plenary will make the admissibility judgment of the application referred to in art. 38 and determine:
p.(None): I - the notification of the user, if he finds the existence of an indication of irregularity; or
p.(None): II - the filing of the application, if there is no evidence of irregularity.
p.(None): § 1 In the case of item I of the caput, the user will have a period of fifteen days to present his manifestation.
p.(None): § 2º No manifestations presented after the period established in § 1 will be received.
p.(None): Art. 40. Once the deadline for presenting the manifestation has expired, the Executive Secretariat will forward the process for deliberation of the CGen Plenary, which
p.(None): you can:
p.(None): I - not accept the merits of the application; or
p.(None): II - comply with the request, when:
p.(None): a) determine that the user retains the access or shipping records, or even the notification, if the irregularity is remedial, under penalty of
p.(None): cancellation of the respective registrations or notification; or
p.(None): b) cancel the access or remittance registrations, or even the notification, if the irregularity is insurmountable, and notify:
p.(None): 1. the bodies and entities referred to in arts. 93 and 109; and
p.(None): 2. the user, to make new registrations or notification.
p.(None): § 1 The following are insurmountable irregularities:
p.(None): I - the existence of associated traditional knowledge of identifiable origin when the registrations or notification indicate only genetic heritage;
p.(None): II - the existence of associated traditional knowledge of identifiable origin, when the registrations or notification indicate only traditional knowledge
p.(None): associate of unidentifiable origin; and
p.(None): III - obtaining prior informed consent in disagreement with the provisions of Law No. 13,123, 2015, and this Decree.
p.(None): § 2 If the finding of the irregularities referred to in items I, II and III of § 1 occurs when the economic exploitation of the product has already started
p.(None): finished or reproductive material, CGen, exceptionally, and as long as no bad faith is set, it may determine that the user retains the
p.(None): notification, and submit, within ninety days, the benefit sharing agreement with the associated traditional knowledge provider.
p.(None): § 3 In the event provided for in § 2, the benefit sharing for the entire corresponding calculation period will be calculated and collected in favor of the
p.(None): beneficiaries and the amounts provided for in the benefit sharing agreement in force on the date of payment.
p.(None): Art. 41. The user may request the issuance of a certificate stating that the respective access and remittance registers as well as the notification:
p.(None): I - applications for verification of evidence of irregularities were not admitted during the verification process; or
p.(None): II - that were subject to a verification request and that this was not accepted.
p.(None): Single paragraph. The certificate referred to in the caput allows the user to be initially warned by the inspection body or entity before receiving
...
p.(None): user.
p.(None): § 1 The certificate provided for in the caput states that the access register has complied with the requirements of Law No. 13,123, of 2015.
p.(None): § 2 n the terms of what determines item IV of § 1 of art. 6 of Law No. 13,123, of 2015, the granting of the certificate of regularity of access will be subject to
p.(None): prior deliberation by CGen, according to procedures to be established in its internal regulations.
p.(None): § 3 Once granted, the certificate of regularity of access:
p.(None): I - declares the regularity of access until the date of its issuance by CGen; and
p.(None): II - prevents the application of administrative sanctions by the competent body or entity specifically in relation to the access activities carried out until the
p.(None): issuing the certificate.
p.(None): § 4 In the situation described in item II of § 3, an error or fraud in the access already attested by CGen has been verified, the inspection body or entity shall adopt
p.(None): administrative measures with CGen to dismantle the certificate previously granted.
p.(None): CHAPTER V
p.(None): BENEFIT BREAKDOWN
p.(None): Section I
p.(None): General provisions
p.(None): Article 43. The benefit sharing referred to in Law No. 13,123, of 2015, will be due as long as there is economic exploitation of:
p.(None): I - finished product arising from access to genetic heritage or associated traditional knowledge carried out after Law No. 13,123, of 2015, or
p.(None): II - reproductive material arising from access to genetic heritage or associated traditional knowledge for the purpose of agricultural activities carried out after the
p.(None): of Law No. 13,123, of 2015.
p.(None): § 1 In the case of the finished product referred to in item I of the caput, the component of genetic heritage or associated traditional knowledge must be one of the
p.(None): main elements of added value.
p.(None): § 2 Under the terms of item XVIII of art. 2 of Law No. 13,123, of 2015, the main elements of added value are the elements whose
p.(None): presence in the finished product is decisive for the existence of functional characteristics or for the formation of market appeal.
p.(None): § 3 For the purposes of this Decree, the following are considered:
p.(None): I - marketing appeal: reference to genetic heritage or associated traditional knowledge, its origin or the differences resulting from it,
p.(None): related to a product, product line or brand, in any visual or auditory media, including marketing campaigns or label prominence
p.(None): of product; and
p.(None): II - functional characteristics: characteristics that determine the main purposes, improve the action of the product or expand its list of purposes.
p.(None): § 4 The use of genetic heritage, exclusively as excipients, will not be considered determinant for the existence of functional characteristics.
p.(None): vehicles or other inert substances, which do not determine functionality.
p.(None): § 5 The substance derived from the metabolism of microorganism will not be considered determinant for the existence of functional characteristics when it is
p.(None): identical to the substance of fossil origin already existing and used instead.
p.(None): § 6 SisGen will provide a specific field in the access register referred to in art. 22 so that the user, if interested, indicates and proves the
p.(None): framing the situation described in § 5.
p.(None): Art. 44. The manufacturer of the finished product or the producer of reproductive material is subject to the sharing of benefits, regardless of
p.(None): who has previously accessed.
p.(None): § 1 In the case of agricultural activity, the sharing of benefits will be due by the producer responsible for the last link in the productive chain of material
p.(None): reproductive.
p.(None): § 2 for the purposes of § 1, the producer responsible for selling reproductive material for production is considered the last link in the production chain,
p.(None): processing and marketing of food, beverages, fibers, energy and planted forests.
p.(None): § 3 In the case of economic exploitation of reproductive material arising from access to genetic heritage or associated traditional knowledge for the purposes of
p.(None): agricultural activities and destined exclusively to the generation of finished products in production chains that do not involve agricultural activity, the
p.(None): benefits will only occur on the economic exploitation of the finished product.
p.(None): Art. 45. The calculation of the net revenue referred to in arts. 20, 21 and 22 of Law No. 13,123, of 2015, will be carried out as determined in § 1 of art. 12 of Decree-Law no.
p.(None): 1,598, of December 26, 1977.
p.(None): § 1 For the purposes of the caput, the manufacturer of the finished product or producer of the reproductive material must declare the annual net revenue for each year
p.(None): tax, obtained with the economic exploitation of each finished product or reproductive material and present a document capable of proving it.
p.(None): § 2 The information provided for in the caput shall be provided to the Ministry of the Environment, in a format defined by him, within ninety days after the
p.(None): end of the fiscal year.
p.(None): § 3 The Ministry of Finance and Ibama will provide the information and technical support necessary to comply with the provisions of this article.
p.(None): § 4 For the purposes of § 3, the Ministry of Finance will observe the provisions of § 2 of art. 198 of Law No. 5,172, of October 25, 1966 - National Tax Code.
p.(None): Art. 46. In the case of finished product or reproductive material produced outside of Brazil, and for the purpose of determining the calculation basis referred to in § 8 of
p.(None): art. 17 of Law No. 13,123, 2015, the Ministry of the Environment may request the manufacturer of the finished product or producer of reproductive material or the
p.(None): joint and several responsible provided for in § 7 of art. 17 of Law No. 13,123, 2015, data and information, duly accompanied by the respective evidence.
p.(None): § 1 The requested data and information must be presented in a format compatible with the systems used by the Ministry of the Environment or in
p.(None): defined by him.
p.(None): § 2 It is the duty of the notified to provide all requested data and information, being responsible for the veracity of its content or for its omission.
p.(None): § 3 The Ministry of Finance will provide the information and technical support necessary to comply with the provisions of the caput.
p.(None): § 4 For the purposes of § 3, the Ministry of Finance will observe the provisions of § 2 of art. 198 of Law No. 5,172, of October 25, 1966 - National Tax Code.
p.(None): Art. 47. The sharing of benefits may consist of monetary and non-monetary modalities.
p.(None): § 1 In the case of economic exploitation of the finished product or reproductive material arising from access to the genetic heritage, the user shall choose
p.(None): one of the modalities of benefit sharing provided for in the caput.
p.(None): § 2 When it comes to the economic exploitation of the finished product or reproductive material arising from access to the traditional knowledge associated with
p.(None): unidentifiable origin, the allocation will be made in monetary form and will be paid to the FNRB.
p.(None): § 3 In the event of economic exploitation of finished product or reproductive material arising from access to associated traditional knowledge of origin
p.(None): identifiable, benefit sharing:
p.(None): I - must be freely negotiated between the user and the indigenous population, the traditional community or the traditional farmer who provides knowledge; and
p.(None): II - the portion owed by the user to the FNRB will correspond to 0.5% (five tenths of percent) of the annual net revenue obtained from the economic exploration or from
p.(None): half of that provided for in a sectoral agreement.
p.(None): Section II
p.(None): Monetary Benefit Sharing
p.(None): Art. 48. The monetary benefit sharing will be destined:
p.(None): I - to indigenous populations, traditional communities and traditional farmers in cases of associated traditional knowledge of identifiable origin,
p.(None): according to an agreement negotiated in a fair and equitable manner between the parties, pursuant to art. 24 of Law No. 13,123, of 2015; and
p.(None): II - to the FNRB, in the case of economic exploitation of the finished product or reproductive material arising from access:
p.(None): a) genetic heritage, in the amount of one percent of the net revenue from the finished product or reproductive material, except in the event of an agreement
p.(None): sector referred to in art. 21 of Law No. 13,123, of 2015;
p.(None): b) associated traditional knowledge of non-identifiable origin, amounting to one percent of the net revenue from the finished product or reproductive material,
p.(None): except in the event of entering into a sectoral agreement referred to in art. 21 of Law No. 13,123, of 2015; and
p.(None): c) associated traditional knowledge of identifiable origin regarding the portion referred to in § 3 of art. 24 of Law No. 13,123, of 2015.
p.(None): Art. 49. The monetary benefit sharing intended for the FNRB will be collected regardless of the benefit sharing agreement and will be calculated after
p.(None): the end of each fiscal year, considering:
p.(None): I - information on the notification of finished product or reproductive material;
p.(None): II - annual net revenue obtained from the economic exploitation of finished product or reproductive material; and
p.(None): III - current sectoral agreement applicable to the finished product or reproductive material.
p.(None): § 1 The amount referring to the sharing of benefits will be collected within 30 days after the information referred to in § 2 of art. 45 as long as there is
p.(None): economical exploitation of the finished product or reproductive material
p.(None): § 2 The first payment of the amount referring to the sharing of benefits must include the benefits earned from the beginning of the economic exploitation until the
p.(None): end of the fiscal year in which there are:
p.(None): I - presentation of the benefit sharing agreement; or
p.(None): II - notification of finished product or reproductive material in cases where the benefit sharing is deposited directly with the FNRB, including exercises
p.(None): previous, if any.
p.(None): Paragraph 3. In the event of a sectoral agreement being concluded, the benefit sharing amount due as of the year of its entry into force will be calculated for the entire period.
p.(None): fiscal year, based on the defined rate.
p.(None): § 4 For the purposes of the provisions of § 8 of art. 17 of Law No. 13,123, of 2015, with no access to information on the product manufacturer's net revenue
p.(None): finished product or reproductive material produced outside of Brazil, the basis for calculating the benefit sharing will be the net revenue of the importer, subsidiary, subsidiary,
p.(None): affiliated, linked or commercial representative of the foreign producer in national territory or abroad.
p.(None): Section III
p.(None): Non-monetary Benefit Sharing
p.(None): Art. 50. The sharing of non-monetary benefits will be made through an agreement signed:
p.(None): I - with indigenous peoples, traditional communities and traditional farmers, providers of associated traditional knowledge of origin
p.(None): identifiable, in cases of economic exploitation of the finished product or reproductive material arising from this knowledge, negotiated in a fair and equitable manner
p.(None): between the parties, under the terms of art. 24 of Law No. 13,123, of 2015; or
p.(None): II - with the Union, in the case of economic exploitation of the finished product or reproductive material arising from access to genetic heritage.
p.(None): § 1 In the benefit sharing agreements implemented through the instruments referred to in items “a”, “e” and “f” of item II of art. 19, of Law nº
p.(None): 13,123, from 2015, the breakdown will be equivalent to seventy-five percent of the forecast for the monetary modality.
p.(None): § 2 In the benefit sharing agreements implemented by means of instruments not provided for in § 1, the allocation will be equivalent to the amount provided for
p.(None): the monetary modality.
p.(None): § 3 The project management expenses, including planning, and accountability, cannot be counted to achieve the percentage provided for in §§
p.(None): 1st and 2nd.
p.(None): § 4 For the purpose of proving the equivalence referred to in §§ 1 and 2, the user must present an estimate, based on market values.
p.(None): § 5 The benefit sharing agreements entered into by the Union will be implemented, preferably, through the instrument referred to in item “a”
p.(None): of item II of art. 19, of Law No. 13,123, of 2015.
p.(None): § 6 The user may not use non-monetary benefit sharing resources in marketing campaigns or any other form of advertising in
p.(None): benefit of your products, product lines or brands.
p.(None): Art. 51. In the case of item II of art. 50, the non-monetary benefit sharing referred to in items “a” and “e” of item II of art. 19 of Law No. 13,123, of
p.(None): 2015, will be aimed at:
p.(None): I - conservation units;
p.(None): II - indigenous lands;
p.(None): III - remaining quilombo territories;
p.(None): IV - rural settlement of family farmers;
p.(None): V - traditional territories under the terms of Decree No. 6,040, of February 7, 2007;
p.(None): VI - national public research and development institutions;
...
p.(None): Art. 52. In the case of item II of art. 50 the sharing of non-monetary benefits referred to in points “b”, “c”, “d” and “f” of item II of art. 19 of Law nº
p.(None): 13,123, from 2015, will be destined to national public bodies and institutions that execute social interest programs.
p.(None): Art. 53. The Ministry of the Environment may create and maintain the bank of proposals for the sharing of non-monetary benefits, which will be widely publicized,
p.(None): including through its website, to comply with the provisions of item II of art. 19 of Law No. 13,123 of 2015.
p.(None): Single paragraph. The proposals referred to in the caput should be aimed at the conservation and sustainable use of biodiversity, valuing and protecting the
p.(None): associated traditional knowledge, serving the public interest.
p.(None): Section IV
p.(None): Exemptions from benefit sharing
p.(None): Art. 54. Economic exploitation of:
p.(None): I - finished product or reproductive material developed by traditional farmers and their cooperatives, with annual gross revenue equal to or less than the limit
p.(None): maximum established in item II of art. 3 of Complementary Law No. 123, of December 14, 2006;
p.(None): II - finished product or reproductive material developed by micro-enterprises, small businesses and individual micro-entrepreneurs,
p.(None): as provided in Complementary Law No. 123, of 2006;
p.(None): III - operations for licensing, transferring or allowing the use of any form of intellectual property right over the finished product,
p.(None): reproductive process or material arising from access to genetic heritage or traditional knowledge associated by third parties;
p.(None): IV - intermediate products along the production chain;
p.(None): V - reproductive material along the productive chain of reproductive material, except for the economic exploitation carried out by the last link in the productive chain;
p.(None): VI - reproductive material arising from access to genetic heritage or associated traditional knowledge for the purposes of agricultural activities and intended
p.(None): exclusively to the generation of finished products; and
p.(None): VII - finished product or reproductive material arising from access to the genetic heritage of species introduced into the national territory by human action, still
p.(None): domesticated, except for the provisions of items I and II of § 3 of art. 18 of Law No. 13,123, of 2015.
p.(None): § 1 The exchange and dissemination of genetic heritage and associated traditional knowledge are also exempt from the obligation to share benefits.
p.(None): practiced among indigenous peoples, traditional communities or traditional farmers for their own benefit and based on their uses, customs and
p.(None): traditions;
p.(None): § 2 The exemption from the benefit sharing referred to in the caput does not relieve the user from the obligation to notify the finished product or reproductive material as
p.(None): also the fulfillment of the other obligations of Law No. 13,123, of 2015.
p.(None): § 3 The provision in § 2 does not apply to the cases provided for in § 4 of art. 8 of Law No. 13,123, of 2015.
p.(None): § 4 The user who fails to fulfill the exemption requirements provided for in Law No. 13,123, 2015, will share benefits in the following fiscal year.
p.(None): § 5 In the cases provided for in items IV, V and VI of the caput, the user must declare that the product or reproductive material fits as a product
p.(None): intermediate and will only be used for activities and processes along the reproductive chain.
p.(None): Section V
p.(None): The benefit-sharing agreement
p.(None): Art. 55. The benefit sharing agreement between user and provider will be negotiated in a fair and equitable manner between the parties, taking into account
p.(None): clarity, loyalty and transparency in the agreed clauses, which should indicate conditions, obligations, types and duration of short, medium and long term benefits,
p.(None): without prejudice to other guidelines and criteria to be established by CGen.
p.(None): Section VI
p.(None): Sectoral agreements
p.(None): Art. 56. The purpose of sectoral agreements is to guarantee the competitiveness of the productive sector in cases where the application of the 1% (one percent) portion of the
p.(None): annual net revenue obtained from the economic exploitation of the finished product or reproductive material arising from access to genetic heritage or knowledge
p.(None): traditional associate of unidentifiable origin characterizes material damage or threat of material damage.
p.(None): § 1 For the purposes of this Decree, the productive sector is the company or group of companies that produce a certain product or similar feature
p.(None): reduction request.
p.(None): Paragraph 2 In the event provided for in the caput, the percentage of payment of monetary benefit sharing may be reduced to up to 0.1% (one tenth percent)
p.(None): of the annual net revenue obtained from economic exploration.
p.(None): Art. 57. The request to reduce the value of the monetary benefit sharing will be addressed to the Ministry of the Environment and will depend on the demonstration that the
p.(None): payment of that percentage has resulted or will result in material damage.
p.(None): § 1 The confidential information contained in the caption referred to in the caput will be treated as so identified by the interested party, provided that the request is
p.(None): justified, and in this case it cannot be revealed without the express authorization of the interested party.
p.(None): § 2 The interested party that provided confidential information must present a summary to be published, with details that allow its understanding, under penalty of being
p.(None): considered non-confidential.
p.(None): § 3 If the Ministry of the Environment considers the request for confidential treatment unjustified and the interested party refuses to adapt it for annexation in
p.(None): non-confidential records, the information will not be known.
p.(None): Art. 58. The request for reduction of benefit sharing will only be known when the signatory companies hold more than:
p.(None): I - fifty percent of the sectorial production value, in the event that said production is concentrated in up to twenty companies; and
p.(None): II - twenty-five percent of the sectorial production value, in the event that said production is concentrated in more than twenty companies.
p.(None): § 1 For the purposes of this article, the sectorial production value is the estimate of the national production value of the finished product or reproductive material
p.(None): arising from access to genetic heritage or associated traditional knowledge of unidentifiable origin as characterized in the reduction request.
p.(None): § 2 The request must be signed by the legal representatives of each of the signatories and will contain:
p.(None): I - documents proving the causal link between the material damage or its threat and the payment of the monetary benefit sharing corresponding to
p.(None): share of 1% (one percent) of annual net revenue; and
p.(None): II - characterization of the finished product or reproductive material for which the reduction of the 1% (one percent) portion provided for in art. 56.
p.(None): § 3 The characterization indicated in item II of § 2 will include the following information:
p.(None): I - accessed genetic heritage;
p.(None): II - associated traditional knowledge accessed;
p.(None): III - raw materials;
p.(None): IV - chemical composition;
p.(None): V - physical characteristics;
p.(None): VI - standards and technical specifications;
p.(None): VII - production process;
p.(None): VIII - uses and applications;
p.(None): IX - degree of substitutability; and
p.(None): X - distribution channels.
p.(None): § 4 The request will not be known if there is an ongoing verification covering the same or similar products.
p.(None): Art. 59. The conditions of art. 58, the Ministry of Environment:
p.(None): I - publish an act initiating the verification of material damage or its threat; and
p.(None): II - notify:
p.(None): a) interested companies;
p.(None): b) the Ministry of Development, Industry and Foreign Trade; and
p.(None): c) the bodies referred to in the sole paragraph of art. 21 of Law No. 13,123, of 2015.
p.(None): § 1 The act referred to in item I of the caput specifies the finished product or the reproductive material object of the verification and the signatory companies of the order.
p.(None): § 2 The manifestation of the Ministry of Development, Industry and Foreign Trade is a condition for the analysis referred to in art. 62 and will be presented within
p.(None): sixty days.
p.(None): § 3 The bodies referred to in item “c” of item II of the caput may manifest themselves within sixty days from the date of notification.
p.(None): Paragraph 4. A period of twenty days, counted from the date of publication of the act referred to in item I of the caput, will be granted for the submission of requests for
p.(None): other parties who consider themselves interested.
...
p.(None): § 2 After the term referred to in the caput has elapsed, and if there is no request for extension, the sectoral agreement will be terminated.
p.(None): § 3 The sectoral agreement may be extended if the conditions that gave rise to its conclusion are maintained.
p.(None): § 4 The request for extension must be made by the interested party, at least, four months before its end.
p.(None): § 5 During the analysis of the request for extension, the sectoral agreement will remain in force.
p.(None): Art. 66. During the term of the sectoral agreement, the contemplated interested party may request a revision of the rate, provided that at least
p.(None): thirty months from the beginning of the agreement.
p.(None): § 1 The request referred to in the caput must be accompanied by evidence that the circumstances that justified the application of the rate reduction
p.(None): granted at that time have changed.
p.(None): § 2 The analysis of the request for review will follow the provisions of this Section and consider only the new facts that justified the request.
p.(None): Art. 67. The final decision on the request for review will rest with the Minister of State for the Environment and will be limited to the reduction or not of the rate.
p.(None): Art. 68. If the request for review is accepted, an addendum to the sectoral agreement in force will be formalized.
p.(None): Article 69. The Minister of State for the Environment's act shall establish the complementary rules to the provisions of this Section.
p.(None): CHAPTER VI
p.(None): INFRINGEMENTS AND ADMINISTRATIVE SANCTIONS
p.(None): Section I
p.(None): General provisions
p.(None): Art. 70. An administrative infraction against genetic heritage or associated traditional knowledge is considered as provided in arts. 78 to 91 of this Decree.
p.(None): Art. 71. Without prejudice to the applicable criminal and civil responsibilities, administrative infractions will be punished with the following sanctions:
p.(None): I - warning;
p.(None): II - fine;
p.(None): III - seizure:
p.(None): a) samples containing the genetic heritage accessed;
p.(None): b) the instruments used to obtain or process the genetic heritage or associated traditional knowledge accessed;
p.(None): c) products derived from access to genetic heritage or associated traditional knowledge; or
p.(None): d) products obtained from information on associated traditional knowledge;
p.(None): IV - temporary suspension of the manufacture and sale of the finished product or reproductive material derived from access to genetic heritage or knowledge
p.(None): traditional associated until regularization;
p.(None): V - embargo of the specific activity related to the infraction;
p.(None): VI - partial or total interdiction of the establishment, activity or enterprise;
p.(None): VII - suspension of certificate or authorization; or
p.(None): VIII - cancellation of certificate or authorization.
p.(None): Single paragraph. The sanctions provided for in items I to VIII of the caput may be applied cumulatively.
p.(None): Art. 72. The assessing agent, when drawing up the notice of infraction, shall indicate the sanctions established in this Decree, observing:
p.(None): I - the gravity of the fact;
p.(None): II - the offender's record of compliance with the legislation regarding genetic heritage and associated traditional knowledge;
p.(None): III - recurrence; and
p.(None): IV - the economic situation of the offender, in the case of a fine.
p.(None): Single paragraph. For the application of the provisions of this article, the competent body or entity may establish, by means of a technical standard, criteria
p.(None): complementary measures for the aggravation and mitigation of administrative sanctions.
p.(None): Art. 73. The fine will be arbitrated by the competent authority, for an infraction, and can vary:
p.(None): 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
p.(None): II - from R $ 10,000.00 (ten thousand reais) to 10,000,000.00 (ten million reais), when the infraction is committed by a legal entity, or with its tender.
p.(None): Art. 74. The committing of a new infraction by the same infringer, in the period of five years, counted from the final and unappealable decision of the administrative decision that has
p.(None): convicted of a previous offense, implies:
p.(None): I - application of the fine in triple, in case of committing the same infraction; or
p.(None): II - application of a double fine, in the case of a distinct offense.
p.(None): § 1 The aggravation will be determined in the procedure of the new infraction, which will include, by copy, the previous infraction notice and the judgment that the
p.(None): confirmed.
p.(None): § 2 Before the judgment of the new infraction, the environmental authority shall verify the existence of a previous infraction notice confirmed in judgment, for the purposes of
p.(None): application of the aggravation of the new penalty.
p.(None): Paragraph 3. The existence of an infraction notice previously confirmed in judgment, the environmental authority shall:
p.(None): I - aggravate the penalty as provided in the caput;
p.(None): II - notify the assessed person so that he / she can express his opinion about the increase in the penalty within ten days; and
p.(None): III - judge the new infraction considering the increase in the penalty.
p.(None): Art. 75. For the sanctions provided for in items III to VI of art. 71, the provisions of Decree No. 6,514, of July 22, 2008, apply as appropriate.
p.(None): Section II
p.(None): Limitation periods
p.(None): Art. 76. Under the terms of Law No. 9,873, of November 23, 1999, the public administration prescribes the action of five years in order to investigate the practice of
p.(None): administrative infractions against genetic heritage and associated traditional knowledge, counted from the date of practice of the act, or, in the case of permanent infraction or
p.(None): continued, from the day it has ceased.
p.(None): § 1 The investigation of the infraction against the genetic heritage and the traditional knowledge associated with the drawing up of the infraction notice by the
p.(None): competent authority or administrative notification.
p.(None): § 2 The intercurrent prescription applies to the procedure for determining the infraction notice that has been paralyzed for more than three years, pending judgment or order,
p.(None): whose records will be filed by letter or at the request of the interested party, without prejudice to the determination of the functional responsibility arising from the
p.(None): stoppage.
p.(None): Art. 77. The prescription is interrupted:
p.(None): I - for making the offender aware by any means, including by public notice;
p.(None): II - for any unequivocal act of the public administration that requires investigation of the fact; and
p.(None): III - by the appellate condemnatory decision.
p.(None): Single paragraph. An unambiguous act of the public administration is considered, for the purpose of the provision of item II, one that implies instruction of the process.
p.(None): Section III
p.(None): Infractions against genetic heritage and associated traditional knowledge
p.(None): Art. 78. Economically exploiting finished product or reproductive material from access to genetic heritage or associated traditional knowledge without
p.(None): prior notification.
p.(None): Minimum fine of R $ 3,000.00 (three thousand reais) and maximum fine of R $ 30,000.00 (thirty thousand reais), in the case of a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of December 14, 2006.
p.(None): Minimum fine of R $ 30,000.00 (thirty thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): § 1 The sanction provided for in the caput will be applied for finished product or reproductive material, regardless of the number of species accessed for the
p.(None): elaboration of the finished product or reproductive material.
p.(None): § 2 The fine penalty is applied twice if there is commercialization abroad of finished product or reproductive material developed as a result of the
p.(None): access.
p.(None): § 3 The same sanctions foreseen in this article incur those who present a benefit sharing agreement in disagreement with the terms defined in items I
p.(None): and II of § 1 of art. 34.
p.(None): Art. 79. Send, directly or through an intermediary, a sample of genetic heritage abroad without prior registration or in disagreement with it.
p.(None): Minimum fine of R $ 20,000.00 (twenty thousand reais) and maximum of R $ 100,000.00 (one hundred thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 50,000.00 (fifty thousand reais) and maximum of R $ 500,000.00 (five hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 100,000.00 (one hundred thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): § 1 The sanction provided for in the caput will be applied:
p.(None): I - by species;
p.(None): II - in triple if the sample is obtained from species included in official lists of Brazilian species threatened with extinction or from Annex I of the Convention
p.(None): on International Trade in Endangered Species of Wild Flora and Fauna - CITES, promulgated by Decree No. 76,623, of November 17,
p.(None): 1975; and
p.(None): III - twice if the sample is obtained from a species contained only in CITES Appendix II, promulgated by Decree nº 76.623, of 1975.
p.(None): § 2 If the remittance is made for the development of biological or chemical weapons, the penalty provided for in the caput will be quadrupled and must be applied
p.(None): the sanctions of embargo, suspension or partial or total interdiction of the establishment, activity or enterprise, of the person responsible for the consignment.
p.(None): Art. 80. Requesting intellectual property rights resulting from access to genetic heritage or associated traditional knowledge, in Brazil or abroad,
p.(None): without prior registration.
p.(None): Minimum fine of R $ 3,000.00 (three thousand reais) and maximum fine of R $ 30,000.00 (thirty thousand reais), in the case of a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 20,000.00 (twenty thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): Art. 81. Disseminate results, final or partial, in scientific or communication media without prior registration:
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 20,000.00 (twenty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 50,000.00 (fifty thousand reais) and maximum of R $ 500,000.00 (five hundred thousand reais), for other legal entities.
p.(None): § 1 The sanction of a fine may be replaced by a warning, when the circumstances provided for in art. 72.
...
p.(None): of art. 3 of Complementary Law No. 123, of December 14, 2006.
p.(None): Minimum fine of R $ 100,000.00 (one hundred thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): Single paragraph. The same sanctions apply to those who obtain prior informed consent from the knowledge provider
p.(None): traditional associated under the terms of the Civil Code.
p.(None): Art. 84. Failing to indicate the origin of associated traditional knowledge of identifiable origin in publications, uses, explorations and disclosures of
p.(None): access results.
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 10,000.00 (ten thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of December 14, 2006.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 500,000.00 (five hundred thousand reais), for other legal entities.
p.(None): Art. 85. Failing to pay the annual installment due to the FNRB resulting from the economic exploitation of finished product or developed reproductive material
p.(None): due to access to genetic heritage or associated traditional knowledge.
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 100,000.00 (one hundred thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for legal entities.
p.(None): § 1 The same sanctions apply to anyone who interrupts or partially complies with the agreed benefit sharing, whether monetary or non-monetary.
p.(None): § 2 Observing the limits provided for in the caput, the fine should not be less than 10% (ten percent) nor more than 30% (thirty percent) of the amount annually
p.(None): due.
p.(None): Art. 86. To elaborate or present information, document, study, report or report totally or partially false, or misleading, either in the official systems or in
p.(None): any other administrative procedure related to genetic heritage or associated traditional knowledge:
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 30,000.00 (thirty thousand reais) and maximum of R $ 300,000.00 (three hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 100,000.00 (one hundred thousand reais) and maximum fine of R $ 5,000,000.00 (five million reais), for other legal entities.
p.(None): Single paragraph. The penalty provided for in the caput will be applied in double if the information, document, study, report or report totally or partially false or
p.(None): misleading information regarding the shipment or sending of a sample to provide services abroad.
p.(None): Art. 87. Failure to comply with suspension, embargo or interdiction resulting from administrative infraction against genetic heritage or traditional knowledge
p.(None): associated:
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 100,000.00 (one hundred thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 50,000.00 (fifty thousand reais) and maximum of R $ 500,000.00 (five hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 200,000.00 (two hundred thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): Art. 88. Obstate or hinder the inspection of the obligations provided for in Law nº 13.123, of 2015: Art.
p.(None): Minimum fine of R $ 5,000.00 (five thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 30,000.00 (thirty thousand reais) and maximum fine of R $ 300,000.00 (three hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 100,000.00 (one hundred thousand reais) and maximum fine of R $ 5,000,000.00 (five million reais), for other legal entities.
p.(None): Art. 89. Failing to adapt within the period established in art. 37 of Law No. 13,123, of 2015:
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 10,000.00 (ten thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law 123, of 2006
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 300,000.00 (three hundred thousand reais), for other legal entities.
p.(None): § 1 The sanction provided for in the caput will be applied for finished product or reproductive material or for each access activity, individually, that fails to
p.(None): promote their respective suitability regardless of the number of species accessed.
p.(None): § 2 The sanction of a fine may be replaced by a warning, when the circumstances provided for in art. 72.
p.(None): § 3 In the event of access to genetic heritage or associated traditional knowledge carried out solely for the purposes of scientific research, the sanction of
p.(None): warning about facts related to the respective registration for purposes of adequacy must precede the application of any other administrative sanction.
p.(None): Art. 90. Failing to regularize within the period established in art. 38 of Law No. 13,123, of 2015:
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 10,000.00 (ten thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): § 1 The sanction provided for in the caput will be applied for finished product or reproductive material or for each access activity, individually, that fails to
p.(None): promote their respective regularization regardless of the number of species accessed.
p.(None): § 2 the sanction of a fine may be replaced by a warning, when the circumstances provided for in art. 72, and whether:
p.(None): I - natural person; or
p.(None): II - legal entity that has made access to genetic heritage or associated traditional knowledge solely for the purpose of scientific research.
p.(None): Art. 91. Failure to meet legal or regulatory requirements, when notified by the competent authority within the period granted:
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 30,000.00 (thirty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 15,000.00 (fifteen thousand reais) and maximum fine of R $ 5,000,000.00 (five million reais), for other legal entities.
p.(None): Single paragraph. The fine sanction may be substituted for the warning, when the circumstances provided for in art. 72.
p.(None): Section IV
p.(None): Administrative procedure for investigating violations
p.(None): Art. 92. Infractions against genetic heritage or associated traditional knowledge will be investigated in a specific administrative process through the
p.(None): drawing up of notice of infraction and respective terms, ensuring the right to ample defense and the adversary.
p.(None): Single paragraph. The administrative process referred to in the caput will be governed by the provisions of Decree No. 6,514, of 2008, except when
p.(None): different provision provided for in this Chapter.
p.(None): Article 93. The following are competent to inspect and investigate the administrative infractions provided for in this Decree:
p.(None): I - Ibama;
p.(None): II - the Navy Command, within the scope of Brazilian jurisdictional waters and the continental shelf; and
p.(None): III - the Ministry of Agriculture, Livestock and Supply, within the scope of access to genetic heritage for agricultural activities, under the terms of art.
p.(None): 3 of Law No. 10,883, of June 16, 2004.
p.(None): § 1 When the offense involves associated traditional knowledge, the official bodies that defend the rights of indigenous peoples, communities
p.(None): traditional farmers and traditional farmers will provide support to Ibama's inspection activities.
p.(None): § 2 Joint act of the Ministers of State for the Environment, Agriculture, Livestock and Supply and Defense will regulate the coordinated action of the
p.(None): supervisory bodies.
p.(None): Art. 94. Of the final decision issued by the bodies provided for in art. 93 CGen may appeal within twenty days.
p.(None): Art. 95. CGen act will establish criteria for the destination of the seized samples, products and instruments, referred to in § 4 of art. 27 of Law nº
p.(None): 13,123, 2015.
p.(None): Single paragraph. As long as the act referred to in the caput has not been edited, the competent authority for inspection shall make the destination, observing the provisions
p.(None): in Decree No. 6,514, of 2008.
p.(None): CHAPTER VII
p.(None): THE NATIONAL BENEFIT SHARING FUND AND THE NATIONAL BENEFIT SHARING PROGRAM
p.(None): Art. 96. The National Benefit Sharing Fund - FNRB, established by Law No. 13,123, of 2015, linked to the Ministry of the Environment, is of a nature
p.(None): financial and is intended to support actions and activities aimed at enhancing the genetic heritage and associated traditional knowledge and promoting their use of
p.(None): sustainable way.
p.(None): § 1 The FNRB's revenue comprises:
p.(None): I - appropriations enshrined in the annual budget law and their additional credits;
p.(None): II - donations;
p.(None): III - amounts collected with the payment of administrative fines imposed due to non-compliance with Law No. 13,123, of 2015;
p.(None): IV - external financial resources arising from contracts, agreements or covenants, especially reserved for the Fund's purposes;
p.(None): V - contributions made by users of genetic heritage or associated traditional knowledge to the National Benefit Sharing Program;
p.(None): VI - amounts arising from the sharing of benefits; and
p.(None): VII - other revenues that may be allocated to it.
p.(None): § 2 The monetary resources deposited in the FNRB resulting from the economic exploitation of finished product or reproductive material arising from access to
p.(None): associated traditional knowledge will be used exclusively for actions, activities and projects for the benefit of holders of traditional knowledge
p.(None): associated companies.
p.(None): § 3º The revenues destined to the FNRB and eventual returns of funds will be collected directly to the Fund, according to procedures defined by the Committee
p.(None): Manager.
p.(None): Article 97. The FNRB will be managed by a Management Committee, a collegiate body composed of:
p.(None): I - by a representative and two alternates:
p.(None): a) the Ministry of the Environment, which will preside over it;
p.(None): b) the Ministry of Finance;
p.(None): c) the Ministry of Agriculture, Livestock and Supply;
p.(None): d) from the Ministry of Social Development and Fight against Hunger;
p.(None): e) from the Ministry of Agrarian Development;
p.(None): f) the Ministry of Science, Technology and Innovation;
p.(None): g) the National Indian Foundation - Funai; and
p.(None): h) the Institute of National Historical and Artistic Heritage - Iphan;
p.(None): II - by seven representatives of entities or organizations representing indigenous populations, traditional communities and traditional farmers, being:
p.(None): a) two nominated by the National Council of Traditional Peoples and Communities - CNPCT;
p.(None): b) two nominated by the National Council for Sustainable Rural Development - Condraf;
...
p.(None): Nutritional - Consea; and
p.(None): III - by a representative of the Brazilian Society for the Progress of Science - SBPC.
p.(None): § 1 The representatives and their alternates will be appointed by the Minister of the Environment, after indication of the respective bodies and entities.
p.(None): § 2 The representatives and alternates will have a two-year term, renewable for an equal period.
p.(None): § 3 In the event of impediments or absences from its president, the Management Committee will be chaired by the alternate representative of the Ministry of the Environment.
p.(None): § 4 The participation in the FNRB Management Committee is considered to be of relevant public interest and will not be remunerated.
p.(None): § 5 To comply with the provisions of item IV of art. 10 of Law No. 13,123, of 2015, the travel and subsistence expenses of the representatives referred to in item II
p.(None): caput will be paid by FNBR.
p.(None): § 6 The Ministry of the Environment may bear the expenses referred to in § 5 in the first two years of operation of the FNBR.
p.(None): § 7 The Management Committee may invite other representatives, without the right to vote, to participate in its meetings.
p.(None): Art. 98. The Management Committee is responsible for:
p.(None): I - decide on the management of the monetary resources deposited in the FNRB, observing the guidelines for the application of the resources established by CGen;
p.(None): II - to define, annually, the percentage of the monetary resources deposited in the FNRB resulting from the economic exploitation of finished product or material
p.(None): reproductive system resulting from access to genetic heritage from ex situ collections, which will be used for the benefit of these collections;
p.(None): III - approve the FNRB Operations Manual, establishing conditions and procedures for the financial execution and the application of resources, including the
p.(None): revenue collection and the hiring, execution, monitoring and evaluation of actions and activities supported by the FNRB;
p.(None): IV - approve the four-year operating plan and review it every two years;
p.(None): V - approve actions, activities and projects to be supported by the FNRB;
p.(None): VI - decide on the hiring of studies and research by the FNRB;
p.(None): VII - approve annual reports of:
p.(None): a) activities and financial execution;
p.(None): b) performance of the financial institution;
p.(None): VIII - establish cooperation instruments, including with States, the Federal District and Municipalities;
p.(None): IX - establish instruments of cooperation and transfer of resources with national public institutions for research, teaching and technical support, including with support
p.(None): financial of FNRB, to follow the actions and activities supported by FNRB; and
p.(None): X - prepare and approve its internal regulations.
p.(None): Single paragraph. The percentage referred to in item II of the caput may not be less than sixty percent or greater than eighty percent.
p.(None): Art. 99. The availability of the FNRB will be maintained in a federal financial institution, which will be responsible for the administration and financial execution of the resources and
p.(None): operationalization of the Fund.
p.(None): Paragraph 1 The depositary fi nancial institution will remunerate the Fund's availabilities, at least, at the average reference rate of the Special Settlement System and of
p.(None): Custody - Selic.
p.(None): § 2 The financial institution's obligations and responsibilities, as well as its remuneration, will be defined in the contract.
p.(None): Art. 100. The National Benefit Sharing Program - PNRB, instituted by art. 33 of Law No. 13,123, of 2015, aims to promote:
p.(None): I - conservation of biological diversity;
p.(None): II - recovery, creation and maintenance of ex situ collections of samples of genetic heritage;
p.(None): III - prospection and training of human resources associated with the use and conservation of genetic heritage or associated traditional knowledge;
p.(None): IV - protection, promotion of the use and enhancement of associated traditional knowledge;
p.(None): V - implementation and development of activities related to the sustainable use of biological diversity, its conservation and benefit sharing;
p.(None): VI - fostering research and technological development associated with genetic heritage and associated traditional knowledge;
p.(None): VII - survey and inventory of genetic heritage, considering the situation and the degree of variation of existing populations, including those in use
p.(None): potential and, when feasible, assessing any threats to them;
p.(None): VIII - support for the efforts of indigenous populations, traditional communities and traditional farmers in sustainable management and conservation of
p.(None): genetic heritage;
p.(None): IX - conservation of wild plants;
p.(None): X - development of an efficient and sustainable ex situ and in situ conservation system and development and transfer of appropriate technologies for
p.(None): this purpose with a view to improving the sustainable use of genetic heritage;
p.(None): XI - monitoring and maintaining the viability, the degree of variation and the integrity of the genetic heritage maintained by collections;
p.(None): XII - adoption of measures to minimize or, if possible, eliminate threats to genetic heritage;
p.(None): XIII - development and maintenance of the various cultivation systems that favor the sustainable use of genetic heritage;
p.(None): XIV - elaboration and execution of Sustainable Development Plans for Traditional Populations or Communities; and
p.(None): XV - other actions related to access to genetic heritage and associated traditional knowledge, as defined by the FNRB Management Committee.
p.(None): § 1 The FNRB may support projects and training activities for the employees of the bodies and entities referred to in § 2 of art. 14.
p.(None): § 2 The FNRB may support projects and activities related to the elaboration of community protocols.
p.(None): Art. 101. FNRB resources must be used in the PNRB to support actions and activities that promote the objectives provided for in art. 100, through
p.(None): agreements, terms of partnership, collaboration or promotion, agreements, adjustments or other instruments of cooperation and transfer of resources provided for by law.
p.(None): Single paragraph. FNRB resources may also be allocated:
p.(None): I - the analysis, supervision, management and monitoring of supported actions, activities and projects;
p.(None): II - the remuneration and coverage of the expenses of the financial institution related to the administration of the Fund.
p.(None): Art. 102. The Ministry of the Environment will exercise the function of Executive Secretary of the FNRB Management Committee and will provide technical and administrative support
p.(None): necessary for the functioning of the FNRB and implementation of the PNRB.
p.(None): CHAPTER VIII
p.(None): TRANSITIONAL PROVISIONS ON FITNESS AND REGULARIZATION OF ACTIVITIES
p.(None): Art. 103. It shall conform to the terms of Law No. 13,123, of 2015, and of this Decree, within one year, counting from the date of the registration being made available by
p.(None): CGen, the user who performed, as of June 30, 2000, the following activities in accordance with Provisional Measure No. 2,186-16, of August 23, 2001:
p.(None): I - access to genetic heritage or associated traditional knowledge; and
p.(None): II - economic exploitation of finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge.
p.(None): § 1 For the purposes of the caput, the user, observing art. 44 of Law No. 13,123, of 2015, must adopt one or more of the following measures, as
p.(None): the case:
p.(None): I - register access to genetic heritage or associated traditional knowledge;
p.(None): II - notify the finished product or the reproductive material object of economic exploitation, pursuant to Law No. 13,123, of 2015 and this Decree; and
p.(None): III - share the benefits related to the economic exploitation carried out as from the date of entry into force of Law No. 13,123, of 2015, under the terms of Chapter V
p.(None): of said Law and Chapter V of this Decree, except when it was done under Provisional Measure 2,186-16, of 2001.
p.(None): § 2 In the case of item III of § 1, the benefit sharing agreed upon pursuant to Provisional Measure No. 2,186-16, of 2001, will be valid for the term stipulated in the
p.(None): contract for the use of genetic heritage and benefit sharing or the benefit sharing project agreed by CGen.
p.(None): Art. 104. Shall be regularized under the terms of Law No. 13,123, of 2015, and of this Decree, within one year, counting from the date the registry is made available by
p.(None): CGen, the user who, between June 30, 2000 and the date of entry into force of Law No. 13,123, 2015, performed the following activities in disagreement with the
p.(None): legislation in force at the time:
p.(None): I - access to genetic heritage or associated traditional knowledge;
p.(None): II - access and economic exploitation of a product or process arising from access to genetic heritage or associated traditional knowledge, which
p.(None): Provisional Measure No. 2,186-16, of 2001;
p.(None): III - remittance of a sample of genetic heritage abroad; or
p.(None): IV - disclosure, transmission or retransmission of data or information that integrate or constitute associated traditional knowledge.
p.(None): § 1 The regularization referred to in the caput is subject to the signing of the Term of Commitment.
p.(None): § 2 In the event of access to genetic heritage or associated traditional knowledge solely for the purposes of scientific research, the user will be
p.(None): exempted from signing the Term of Commitment, being regularized through registration or authorization of the activity, as the case may be.
p.(None): § 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 2001, and
p.(None): specified in arts. 15 and 20 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 the
p.(None): Law No. 13,123, of 2015.
p.(None): § 4 For the purposes of regularizing the patent applications filed at the INPI during the term of Provisional Measure 2,186-16, of 2001, the applicant must
p.(None): present the proof of registration or authorization referred to in this article.
p.(None): § 5º The user who performed activities in disagreement with Provisional Measure nº 2.186-16, of 2001, even though he obtained authorization during the term of the
p.(None): said Provisional Measure, may, at its discretion, adhere to the regularization process provided for in art. 38 of Law No. 13,123, of 2015.
p.(None): § 6 For the purposes of § 5, the contract for the use of genetic heritage and the sharing of benefits or the project for the sharing of benefits, annulled by the
p.(None): CGen will integrate the commitment term.
p.(None): CHAPTER IX
p.(None): FINAL DISPOSITIONS
p.(None): Art. 105. For the purposes of the provision in item XVII of art. 2 of Law No. 13,123, 2015, the inputs used in agricultural activities are intermediate products.
p.(None): Single paragraph. Inputs for agricultural activities are goods that are consumed in the production activity or that undergo changes, such as
p.(None): wear, damage or loss of physical or chemical properties, depending on the action directly exerted on the product being manufactured, provided they are not
p.(None): included in property, plant and equipment.
p.(None): Art. 106. CGen may create a database for voluntary registration of prior informed consent, granted or denied by the holders of
p.(None): associated traditional knowledge.
p.(None): Art. 107. The following tests, exams and activities, when they are not an integral part of research or technological development, do not configure access to the
p.(None): genetic heritage under the terms of Law No. 13,123, of 2015:
p.(None): I - affiliation or paternity test, sexing technique and karyotype or DNA analysis and other molecular analyzes aimed at the identification of a species
p.(None): or specimen;
p.(None): II - diagnostic tests and clinical examinations for the direct or indirect identification of aetiological agents or hereditary pathologies in an individual;
p.(None): III - extraction, by means of grinding, pressing or bleeding that results in fixed oils;
p.(None): IV - purification of fixed oils that results in a product whose characteristics are identical to those of the original raw material;
p.(None): V - test that aims to assess mortality rates, growth or multiplication of parasites, pathogens, pests and disease vectors;
p.(None): VI - comparison and extraction of information of genetic origin available in national and international databases
p.(None): VI - extracts processing, physical separation, pasteurization, fermentation, pH assessment, total acidity, soluble solids, bacteria and yeast count,
p.(None): molds, faecal coliforms and totals of genetic heritage samples; and
p.(None): VII - physical, chemical and physical-chemical characterization for determining the nutritional information of foods;
p.(None): Single paragraph. It does not configure access to genetic heritage to read or consult information of genetic origin available in databases
p.(None): national and international, even though they are an integral part of technological research and development.
p.(None): Art. 108. The plant or animal genetic improvement carried out by an indigenous population, traditional community or traditional farmer is exempt from registration in the
p.(None): terms of item VI of art. 10 of Law No. 13,123, of 2015.
p.(None): Art. 109. To comply with the provisions of § 2 of art. 12 of Law No. 13,123, of 2015, the user, when requesting intellectual property rights, must
p.(None): inform whether there was access to genetic heritage or associated traditional knowledge, as well as whether there is an access register carried out under the terms of this Decree.
p.(None): Art. 110. If the registration does not exist or in case of its cancellation, Ibama or CGen will communicate the organ and entity provided for in art. 109 for
p.(None): that the applicant for the intellectual property right to present proof of registration in thirty days, under penalty of
p.(None): intellectual property right application.
p.(None): Single paragraph. In the event of no registration, the period of one year referred to in arts. 36, 37 and 38 of Law No. 13,123, of 2015.
p.(None): Art. 111. CGen, with the collaboration of accredited institutions under the terms of item V of art. 15 of Provisional Measure No. 2,186-16, of 2001, will register in the
p.(None): authorizations already issued.
p.(None): Art. 112. Based on the Common Nomenclature of Mercosur - NCM, the List of Classification of Benefit Sharing referred to in § 9 of art.
p.(None): 17 of Law No. 13,123, of 2015, attached to this Decree.
p.(None): Single paragraph. The list referred to in the caput will have an exemplary character and will not exclude the application of the benefit sharing incidence rules
p.(None): provided for in arts. 17 and 18 of Law No. 13,123, of 2015.
p.(None): Art. 113. The Ministry of Agriculture, Livestock and Supply will periodically prepare, publish and review the reference list of animal and plant species
p.(None): domesticated or cultivated that were introduced in the national territory, used in agricultural activities.
p.(None): Single paragraph. The list referred to in the caput will indicate the species that form spontaneous populations and the varieties that have acquired properties
p.(None): distinctive characteristics in the country.
p.(None): Art. 114. Joint act of the Ministers of State for Agriculture, Livestock and Supply and Agrarian Development will publish a list of traditional varieties
p.(None): local or Creole and locally adapted or Creole breeds.
p.(None): Art. 115. The Ministry of Health and the Ministry of the Environment, in a joint Ordinance, will regulate a simplified procedure for carrying out remittances.
p.(None): genetic heritage related to the Public Health Emergency Situation of National Importance - ESPIN, which is dealt with in Decree nº 7.616, of November 17,
p.(None): 2011.
p.(None): § 1 The consignment provided for in the caput will be destined exclusively to research and technological development declared in the Material Transfer Term,
p.(None): necessarily linked to the epidemiological situation, and the use of this genetic heritage accessed for other purposes is prohibited.
p.(None): § 2 The benefits resulting from the economic exploitation of the finished product or reproductive material arising from research or technological development that
p.(None): this article deals with will be distributed under the terms of Law No. 13,123, 2015, and this Decree.
p.(None): Art. 116. The Ministry of the Environment, in coordination with the Ministry of Foreign Affairs, may enter into cooperation agreements and agreements with
p.(None): entities in other countries for the purpose of complying with the provisions of Law No. 13,123 of 2015.
p.(None): Art. 117. The provisions of this Decree do not exclude the powers of the Ministry of Science, Technology and Innovation to supervise and control the activities of
p.(None): scientific research in the national territory, when carried out by foreigners, which imply entering the country.
p.(None): Art. 118. The user who requested any intellectual property right, economically exploited the finished product or reproductive material, or disclosed
p.(None): results, final or partial, in scientific or communication media, between November 17, 2015 and the date of availability of the registration, must register the
p.(None): activities referred to in art. 12 of Law No. 13,123, 2015 and notify the finished product or reproductive material developed as a result of access.
p.(None): Paragraph 1 The deadline for registration or notification referred to in the caput will be 1 (one) year, counted from the date the registration is made available by CGen.
p.(None): § 2 Once the registration or notification is made in a timely manner, the user will not be subject to administrative sanction.
p.(None): Art. 119. The following are revoked:
p.(None): I - Decree No. 3,945, of September 28, 2001;
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Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): other parties who consider themselves interested.
p.(None): Art. 60. The finding of material damage or its threat will be based on evidence and will include an objective examination of the effect of benefit sharing
p.(None): on the price of the product and the consequent impact on the productive sector.
p.(None): § 1 The examination referred to in the caput will include, among others, the evaluation of the following economic factors and indices:
p.(None): I - real or potential fall:
p.(None): a) sales;
p.(None): b) profits;
p.(None): c) production;
p.(None): d) market share;
p.(None): e) productivity; and
p.(None): f) the degree of utilization of installed capacity;
p.(None): II - actual or potential negative effects on:
p.(None): a) stocks;
p.(None): b) employment;
p.(None): c) wages; and
p.(None): d) growth of the productive sector;
p.(None): III - the contraction in demand or changes in consumption patterns;
p.(None): IV - competition between domestic and foreign producers; and
p.(None): V - export performance.
p.(None): § 2 For the purposes of the provisions of this article, the effects of the payment of the monetary benefit sharing corresponding to the 1% portion must be segregated.
p.(None): (one percent) of the annual net revenue from the effects arising from other causes that may have caused material damage or its threat.
p.(None): § 3 For the examination of the impact referred to in the caput, it will be considered whether the value of the benefit sharing had the effect of significantly depressing the
p.(None): sales.
p.(None): Art. 61. The Ministry of Development, Industry and Foreign Trade will make the analysis referred to in art. 60 and forward a technical opinion on the request for
p.(None): reduction of the benefit sharing amount to the Ministry of the Environment, within the period referred to in § 2 of art. 59.
p.(None): Art. 62. Received the opinion referred to in art. 61, the Ministry of the Environment will issue a technical opinion that should consider the content of the manifestations:
p.(None): I - the Ministry of Development, Industry and Foreign Trade; and
p.(None): II - the official bodies for the defense of the rights of indigenous peoples, traditional communities or traditional farmers, when presented.
p.(None): Paragraph 1 Interested companies will be notified to, within thirty days, comment on the opinion referred to in the caput.
p.(None): § 2 The Ministry of the Environment may accept the statements of interested companies, at which time it will issue a new opinion.
p.(None): Art. 63. The opinion will be submitted to the Minister of State for the Environment, who will decide, on a motivated basis, on the realization or not of the sectoral agreement.
p.(None): Art. 64. The terms of the sectoral agreement in force apply to all products produced in the national territory that fall under the terms of the decision, even
p.(None): produced by companies that have not subscribed to the reduction request.
p.(None): Art. 65. The sectoral agreement will be in force for sixty months from the publication of the decision referred to in art. 63.
p.(None): § 1 In the event of a sectoral agreement in force at the time of payment of the benefit sharing referring to a given finished product or
p.(None): reproductive material, the rate to be paid will be that defined in the sectoral agreement.
p.(None): § 2 After the term referred to in the caput has elapsed, and if there is no request for extension, the sectoral agreement will be terminated.
p.(None): § 3 The sectoral agreement may be extended if the conditions that gave rise to its conclusion are maintained.
p.(None): § 4 The request for extension must be made by the interested party, at least, four months before its end.
p.(None): § 5 During the analysis of the request for extension, the sectoral agreement will remain in force.
p.(None): Art. 66. During the term of the sectoral agreement, the contemplated interested party may request a revision of the rate, provided that at least
p.(None): thirty months from the beginning of the agreement.
p.(None): § 1 The request referred to in the caput must be accompanied by evidence that the circumstances that justified the application of the rate reduction
p.(None): granted at that time have changed.
...
p.(None): complementary measures for the aggravation and mitigation of administrative sanctions.
p.(None): Art. 73. The fine will be arbitrated by the competent authority, for an infraction, and can vary:
p.(None): 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
p.(None): II - from R $ 10,000.00 (ten thousand reais) to 10,000,000.00 (ten million reais), when the infraction is committed by a legal entity, or with its tender.
p.(None): Art. 74. The committing of a new infraction by the same infringer, in the period of five years, counted from the final and unappealable decision of the administrative decision that has
p.(None): convicted of a previous offense, implies:
p.(None): I - application of the fine in triple, in case of committing the same infraction; or
p.(None): II - application of a double fine, in the case of a distinct offense.
p.(None): § 1 The aggravation will be determined in the procedure of the new infraction, which will include, by copy, the previous infraction notice and the judgment that the
p.(None): confirmed.
p.(None): § 2 Before the judgment of the new infraction, the environmental authority shall verify the existence of a previous infraction notice confirmed in judgment, for the purposes of
p.(None): application of the aggravation of the new penalty.
p.(None): Paragraph 3. The existence of an infraction notice previously confirmed in judgment, the environmental authority shall:
p.(None): I - aggravate the penalty as provided in the caput;
p.(None): II - notify the assessed person so that he / she can express his opinion about the increase in the penalty within ten days; and
p.(None): III - judge the new infraction considering the increase in the penalty.
p.(None): Art. 75. For the sanctions provided for in items III to VI of art. 71, the provisions of Decree No. 6,514, of July 22, 2008, apply as appropriate.
p.(None): Section II
p.(None): Limitation periods
p.(None): Art. 76. Under the terms of Law No. 9,873, of November 23, 1999, the public administration prescribes the action of five years in order to investigate the practice of
p.(None): administrative infractions against genetic heritage and associated traditional knowledge, counted from the date of practice of the act, or, in the case of permanent infraction or
p.(None): continued, from the day it has ceased.
p.(None): § 1 The investigation of the infraction against the genetic heritage and the traditional knowledge associated with the drawing up of the infraction notice by the
p.(None): competent authority or administrative notification.
p.(None): § 2 The intercurrent prescription applies to the procedure for determining the infraction notice that has been paralyzed for more than three years, pending judgment or order,
p.(None): whose records will be filed by letter or at the request of the interested party, without prejudice to the determination of the functional responsibility arising from the
p.(None): stoppage.
p.(None): Art. 77. The prescription is interrupted:
p.(None): I - for making the offender aware by any means, including by public notice;
p.(None): II - for any unequivocal act of the public administration that requires investigation of the fact; and
p.(None): III - by the appellate condemnatory decision.
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Economic / Food Insecurity
Searching for indicator hunger:
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p.(None): § 1 Under the terms of art. 7 of Law No. 13,123 of 2015, the system provided for in the caput will be managed by the Executive Secretariat of CGen and will have the
p.(None): information necessary for the traceability of activities resulting from access to genetic heritage or associated traditional knowledge
p.(None): systems databases:
p.(None): I - protection and registration of cultivars, seeds and seedlings, agricultural products, establishments and inputs, traffic information
p.(None): international agricultural products and inputs from the Ministry of Agriculture, Livestock and Supply;
p.(None): II - import and export registration under the Integrated Foreign Trade System - Siscomex, instituted by Decree No. 660, of September 25,
p.(None): 1992;
p.(None): III - information on curricula, research groups, institutions registered on the Lattes Platform of the National Council for Scientific Development and
p.(None): Technological - CNPq;
p.(None): IV - information on research and commercial release of genetically modified organisms and derivatives, from the National Technical Commission for
p.(None): Biosafety - CTNBio from the Ministry of Science, Technology and Innovation;
p.(None): V - registration of products from the National Health Surveillance Agency - Anvisa;
p.(None): VI - granting and guaranteeing intellectual property rights of the National Institute of Industrial Property - INPI;
p.(None): VII - national register of social information of the Ministry of Social Development and Fight against Hunger; and
p.(None): VIII - information on cultural heritage of the National Information and Cultural Indicators System - SNIIC, of the Ministry of Culture.
p.(None): § 2 The bodies and entities referred to in this article shall adopt the necessary measures to guarantee access to information through the traceability system and the
p.(None): Ministry of the Environment will adopt the necessary measures for the integration of the information contained in the databases provided for in § 1.
p.(None): § 3 In the impossibility of adopting the measures provided for in § 2, the information must be forwarded to CGen within thirty days, counted from the
p.(None): solicitation.
p.(None): § 4 CGen may also:
p.(None): I - request additional information from the bodies and entities provided for in § 1;
p.(None): II - to request other organs and entities of the federal public administration information that it deems necessary for the traceability of activities
p.(None): arising from access to genetic heritage or associated traditional knowledge; and
p.(None): III - adopt measures to guarantee access to information through the traceability system and the integration of databases with different bodies and entities
p.(None): those provided for in items I to VIII of §1 of the caput.
p.(None): § 5 The bodies and entities of the federal public administration that provide confidential information to CGen shall indicate this circumstance
p.(None): express, specifying, when applicable, the classification of the information regarding the degree and term of confidentiality, in accordance with the provisions of Law No. 12,527, of November 18,
p.(None): 2011, or in specific legislation.
p.(None): § 6 The Executive Secretariat of CGen will ensure the legal confidentiality of information, respecting the classification of information regarding the degree and term of confidentiality,
p.(None): When it's the case.
p.(None): § 7 For the purposes of the caput, CGen may have access to the data contained in systems of the Secretariat of the Federal Revenue of Brazil contained in
p.(None): public domain registration and that do not inform the taxpayers' economic or financial situation.
p.(None): Art. 6 CGen will operate through:
p.(None): I - Plenary;
p.(None): II - Thematic Chambers;
p.(None): III - Sectorial Chambers; and
p.(None): IV - Executive Secretariat.
p.(None): Section II
p.(None): From the Plenary
p.(None): Article 7. The CGen Plenary will be composed of twenty-one members, twelve representatives of federal public administration bodies and nine
p.(None): representatives of civil society, distributed as follows:
p.(None): I - one representative from each of the following ministries:
p.(None): a) Ministry of the Environment;
p.(None): b) Ministry of Justice;
p.(None): c) Ministry of Health;
p.(None): d) Ministry of Foreign Affairs;
p.(None): e) Ministry of Agriculture, Livestock and Supply;
p.(None): f) Ministry of Culture;
p.(None): g) Ministry of Social Development and Fight against Hunger;
p.(None): h) Ministry of Defense;
p.(None): i) Ministry of Development, Industry and Foreign Trade;
p.(None): j) Ministry of Science, Technology and Innovation; and
p.(None): k) Ministry of Agrarian Development;
p.(None): II - three representatives of entities or organizations in the business sector, being:
p.(None): a) one appointed by the National Confederation of Industry - CNI;
p.(None): b) one nominated by the National Agriculture Confederation - CNA; and
p.(None): c) one nominated alternatively and successively by CNI and CNA;
p.(None): III - three representatives of entities or organizations in the academic sector, being:
p.(None): a) one nominated by the Brazilian Society for the Progress of Science - SBPC;
p.(None): b) one nominated by the Brazilian Association of Anthropology - ABA; and
p.(None): c) one nominated by the Brazilian Academy of Sciences - ABC; and
p.(None): IV - three representatives of entities or organizations representing indigenous populations, traditional communities and traditional farmers, being:
p.(None): a) one appointed by representatives of traditional peoples and communities and their organizations of the National Council of Traditional Peoples and Communities -
p.(None): CNPCT;
p.(None): b) one appointed by representatives of family farmers and their organizations from the National Council for Sustainable Rural Development - Condraf; and
p.(None): c) one nominated by representatives of indigenous peoples and organizations that are members of the National Council for Indigenous Policy - CNPI.
p.(None): § 1 CGen will be chaired by the senior adviser to the Ministry of the Environment and, in his impediments or absences, by the respective alternate.
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p.(None): sustainable way.
p.(None): § 1 The FNRB's revenue comprises:
p.(None): I - appropriations enshrined in the annual budget law and their additional credits;
p.(None): II - donations;
p.(None): III - amounts collected with the payment of administrative fines imposed due to non-compliance with Law No. 13,123, of 2015;
p.(None): IV - external financial resources arising from contracts, agreements or covenants, especially reserved for the Fund's purposes;
p.(None): V - contributions made by users of genetic heritage or associated traditional knowledge to the National Benefit Sharing Program;
p.(None): VI - amounts arising from the sharing of benefits; and
p.(None): VII - other revenues that may be allocated to it.
p.(None): § 2 The monetary resources deposited in the FNRB resulting from the economic exploitation of finished product or reproductive material arising from access to
p.(None): associated traditional knowledge will be used exclusively for actions, activities and projects for the benefit of holders of traditional knowledge
p.(None): associated companies.
p.(None): § 3º The revenues destined to the FNRB and eventual returns of funds will be collected directly to the Fund, according to procedures defined by the Committee
p.(None): Manager.
p.(None): Article 97. The FNRB will be managed by a Management Committee, a collegiate body composed of:
p.(None): I - by a representative and two alternates:
p.(None): a) the Ministry of the Environment, which will preside over it;
p.(None): b) the Ministry of Finance;
p.(None): c) the Ministry of Agriculture, Livestock and Supply;
p.(None): d) from the Ministry of Social Development and Fight against Hunger;
p.(None): e) from the Ministry of Agrarian Development;
p.(None): f) the Ministry of Science, Technology and Innovation;
p.(None): g) the National Indian Foundation - Funai; and
p.(None): h) the Institute of National Historical and Artistic Heritage - Iphan;
p.(None): II - by seven representatives of entities or organizations representing indigenous populations, traditional communities and traditional farmers, being:
p.(None): a) two nominated by the National Council of Traditional Peoples and Communities - CNPCT;
p.(None): b) two nominated by the National Council for Sustainable Rural Development - Condraf;
p.(None): c) two nominated by representatives of indigenous peoples and organizations that are members of the National Council for Indigenous Policy - CNPI; and
p.(None): d) a representative of the indigenous population, traditional community or traditional farmer appointed by the National Council for Food Security and
p.(None): Nutritional - Consea; and
p.(None): III - by a representative of the Brazilian Society for the Progress of Science - SBPC.
p.(None): § 1 The representatives and their alternates will be appointed by the Minister of the Environment, after indication of the respective bodies and entities.
p.(None): § 2 The representatives and alternates will have a two-year term, renewable for an equal period.
p.(None): § 3 In the event of impediments or absences from its president, the Management Committee will be chaired by the alternate representative of the Ministry of the Environment.
p.(None): § 4 The participation in the FNRB Management Committee is considered to be of relevant public interest and will not be remunerated.
...
Economic / investors/intellectual rights
Searching for indicator intellectual rights:
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p.(None): possible.
p.(None): § 4º CGen will define in technical standard:
p.(None): I - the strictest taxonomic level to be informed, in research cases with the objective of evaluating or elucidating the genetic diversity or the evolutionary history of
p.(None): a taxonomic species or group;
p.(None): II - how to indicate the most specific geographic location possible, in cases where access is exclusively for research purposes in which they are
p.(None): more than one hundred records of origin are required per registration; and
p.(None): III - how to indicate the genetic heritage, in cases of access from samples of substrates containing non-isolated microorganisms.
p.(None): § 5 The user must perform a new registration when there is a change in the genetic heritage or associated traditional knowledge accessed or the objective
p.(None): access.
p.(None): Art. 23. After completing the form referred to in art. 22 SisGen will automatically issue proof of access registration.
p.(None): § 1 The proof of access registration constitutes a suitable document to demonstrate that the user provided the information that was required and produces the
p.(None): following effects:
p.(None): I - allows, under the terms of § 2 of art. 12 of Law No. 13,123, of 2015:
p.(None): a) the application for any property and intellectual rights;
p.(None): b) the commercialization of an intermediate product;
p.(None): c) the dissemination of the results, final or partial, of research or technological development, in scientific or communication media; and
p.(None): d) notification of finished product or reproductive material developed as a result of access; and
p.(None): II - establishes the start of the verification procedure provided for in Section VII of this Chapter.
p.(None): § 2º The user will not need to wait for the verification procedure to finish to carry out the activities referred to in item I of § 1.
p.(None): Art. 24. Sisgen will provide an electronic form in the access register so that the national legal entity, public or private, registers the sending of a sample
p.(None): that contains genetic heritage for the provision of services abroad as part of research or technological development.
p.(None): § 1 The national legal entity, public or private, may authorize the natural person responsible for technological research or development to complete the
p.(None): shipping register.
p.(None): § 2 The registration register referred to in the caput will require:
p.(None): I - information about the recipient institution abroad, including contact information and indication of legal representative; and
p.(None): II - information of the samples to be sent, containing the identification of the genetic heritage to be sent.
p.(None): § 3 The sending of a sample containing genetic heritage for the provision of services abroad, under the terms of item XXX of art. 2 of Law No. 13,123, of
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): Sub-branch for Legal Affairs
p.(None): DECREE No. 8.772, OF MAY 11, 2016
p.(None): Regulates Law No. 13,123, of May 20, 2015, which provides for access
p.(None): genetic heritage, protection and access to traditional knowledge
p.(None): and the sharing of benefits for conservation and sustainable use
p.(None): biodiversity.
p.(None): THE PRESIDENT OF THE REPUBLIC, using the powers conferred on her by art. 84, caput, item IV and item VI, item “a”, of the Constitution, and in view of the
p.(None): provided for in Law No. 13,123, of May 20, 2015,
p.(None): DECREE:
p.(None): CHAPTER I
p.(None): PRELIMINARY PROVISIONS
p.(None): Art. 1 This Decree regulates Law No. 13,123, of May 20, 2015, which provides for access to genetic heritage, protection and access to
p.(None): associated traditional knowledge and benefit sharing for conservation and sustainable use of biodiversity.
p.(None): § 1 The part of the genetic heritage existing in the national territory is considered, for the purposes of this Decree, the microorganism that has been isolated from
p.(None): substrates of the national territory, the territorial sea, the exclusive economic zone or the continental shelf.
p.(None): § 2 The microorganism will not be considered a national genetic heritage when the user, upon request by the competent authority, proves:
p.(None): I - that was isolated from substrates that are not from the national territory, the territorial sea, the exclusive economic zone or the continental shelf; and
p.(None): II - the regularity of its import.
p.(None): § 3 The plant and animal species introduced in the Country will only be considered genetic heritage found in conditions in situ in the national territory
p.(None): when they form spontaneous populations that have acquired their own distinctive characteristics in the country.
p.(None): § 4 The genetic heritage found in situ conditions is also considered to be the variety from a species introduced in the national territory with
p.(None): genetic diversity developed or adapted by indigenous populations, traditional communities or traditional farmers, including combined natural selection
p.(None): with human selection in the local environment, which is not substantially similar to commercial cultivars.
p.(None): Art. 2 The following activities are subject to the requirements of Law No. 13,123, 2015, and this Decree:
p.(None): I - access to genetic heritage or associated traditional knowledge;
p.(None): II - sending samples of genetic heritage abroad; and
p.(None): III - economic exploitation of finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge
p.(None): carried out after the entry into force of Law No. 13,123, of 2015.
p.(None): § 1 For the purposes of the provision in item II of the caput, the practice of any research or technological development activity that is carried out after 17
p.(None): November 2015, will be, regardless of the date of its beginning, considered as access made after the entry into force of Law No. 13,123, of 2015.
p.(None): § 2 The activities carried out between June 30, 2000 and November 17, 2015 must comply with the provisions of Chapter VIII of this Decree.
p.(None): Art. 3 The access to genetic heritage or associated traditional knowledge is not subject to the requirements of Law No. 13,123, 2015
p.(None): completed before June 30, 2000 and the economic exploitation of the finished product or reproductive material resulting therefrom.
p.(None): § 1 For the purposes of the caput, and when requested by the competent authority, the user must prove that all stages of access have ended
p.(None): before June 30, 2000.
p.(None): § 2 The proof referred to in § 1 must occur through:
p.(None): I - in the case of research:
p.(None): a) publication of an article in a scientific journal;
p.(None): b) communication at scientific events;
p.(None): c) filing a patent application;
p.(None): d) report of completion of the research with a public funding agency or entity; or
p.(None): e) publication of course completion papers, master's dissertations, doctoral theses; and
p.(None): II - in the case of technological development:
p.(None): a) filing a patent application;
p.(None): b) cultivar registration;
p.(None): c) product registration with public agencies; or
p.(None): d) proof of commercialization of the product.
p.(None): § 3 In the case of economic exploitation of finished product or reproductive material, in addition to the provisions of items I and II of § 2, the user must prove
p.(None): that the completed access was sufficient to obtain the finished product or reproductive material subject to economic exploitation.
p.(None): § 4 For the purposes of § 3, it is considered that the completed access was sufficient to obtain the finished product or reproductive material object of the exploration
p.(None): when there is no research or technological development activity after June 30, 2000.
p.(None): § 5 The Genetic Heritage Management Council may:
p.(None): I - define other means of proof in addition to those provided for in items I and II of § 2; and
p.(None): II - issue, upon request and proof, a document attesting to the user's qualification in the situations provided for in this article.
p.(None): CHAPTER II
...
p.(None): d) products obtained from information on associated traditional knowledge;
p.(None): IV - temporary suspension of the manufacture and sale of the finished product or reproductive material derived from access to genetic heritage or knowledge
p.(None): traditional associated until regularization;
p.(None): V - embargo of the specific activity related to the infraction;
p.(None): VI - partial or total interdiction of the establishment, activity or enterprise;
p.(None): VII - suspension of certificate or authorization; or
p.(None): VIII - cancellation of certificate or authorization.
p.(None): Single paragraph. The sanctions provided for in items I to VIII of the caput may be applied cumulatively.
p.(None): Art. 72. The assessing agent, when drawing up the notice of infraction, shall indicate the sanctions established in this Decree, observing:
p.(None): I - the gravity of the fact;
p.(None): II - the offender's record of compliance with the legislation regarding genetic heritage and associated traditional knowledge;
p.(None): III - recurrence; and
p.(None): IV - the economic situation of the offender, in the case of a fine.
p.(None): Single paragraph. For the application of the provisions of this article, the competent body or entity may establish, by means of a technical standard, criteria
p.(None): complementary measures for the aggravation and mitigation of administrative sanctions.
p.(None): Art. 73. The fine will be arbitrated by the competent authority, for an infraction, and can vary:
p.(None): 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
p.(None): II - from R $ 10,000.00 (ten thousand reais) to 10,000,000.00 (ten million reais), when the infraction is committed by a legal entity, or with its tender.
p.(None): Art. 74. The committing of a new infraction by the same infringer, in the period of five years, counted from the final and unappealable decision of the administrative decision that has
p.(None): convicted of a previous offense, implies:
p.(None): I - application of the fine in triple, in case of committing the same infraction; or
p.(None): II - application of a double fine, in the case of a distinct offense.
p.(None): § 1 The aggravation will be determined in the procedure of the new infraction, which will include, by copy, the previous infraction notice and the judgment that the
p.(None): confirmed.
p.(None): § 2 Before the judgment of the new infraction, the environmental authority shall verify the existence of a previous infraction notice confirmed in judgment, for the purposes of
p.(None): application of the aggravation of the new penalty.
p.(None): Paragraph 3. The existence of an infraction notice previously confirmed in judgment, the environmental authority shall:
p.(None): I - aggravate the penalty as provided in the caput;
p.(None): II - notify the assessed person so that he / she can express his opinion about the increase in the penalty within ten days; and
p.(None): III - judge the new infraction considering the increase in the penalty.
p.(None): Art. 75. For the sanctions provided for in items III to VI of art. 71, the provisions of Decree No. 6,514, of July 22, 2008, apply as appropriate.
p.(None): Section II
p.(None): Limitation periods
p.(None): Art. 76. Under the terms of Law No. 9,873, of November 23, 1999, the public administration prescribes the action of five years in order to investigate the practice of
p.(None): administrative infractions against genetic heritage and associated traditional knowledge, counted from the date of practice of the act, or, in the case of permanent infraction or
p.(None): continued, from the day it has ceased.
p.(None): § 1 The investigation of the infraction against the genetic heritage and the traditional knowledge associated with the drawing up of the infraction notice by the
p.(None): competent authority or administrative notification.
p.(None): § 2 The intercurrent prescription applies to the procedure for determining the infraction notice that has been paralyzed for more than three years, pending judgment or order,
p.(None): whose records will be filed by letter or at the request of the interested party, without prejudice to the determination of the functional responsibility arising from the
p.(None): stoppage.
p.(None): Art. 77. The prescription is interrupted:
p.(None): I - for making the offender aware by any means, including by public notice;
p.(None): II - for any unequivocal act of the public administration that requires investigation of the fact; and
p.(None): III - by the appellate condemnatory decision.
p.(None): Single paragraph. An unambiguous act of the public administration is considered, for the purpose of the provision of item II, one that implies instruction of the process.
p.(None): Section III
p.(None): Infractions against genetic heritage and associated traditional knowledge
p.(None): Art. 78. Economically exploiting finished product or reproductive material from access to genetic heritage or associated traditional knowledge without
p.(None): prior notification.
p.(None): Minimum fine of R $ 3,000.00 (three thousand reais) and maximum fine of R $ 30,000.00 (thirty thousand reais), in the case of a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
...
p.(None): warning about facts related to the respective registration for purposes of adequacy must precede the application of any other administrative sanction.
p.(None): Art. 90. Failing to regularize within the period established in art. 38 of Law No. 13,123, of 2015:
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 10,000.00 (ten thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 50,000.00 (fifty thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 10,000,000.00 (ten million reais), for other legal entities.
p.(None): § 1 The sanction provided for in the caput will be applied for finished product or reproductive material or for each access activity, individually, that fails to
p.(None): promote their respective regularization regardless of the number of species accessed.
p.(None): § 2 the sanction of a fine may be replaced by a warning, when the circumstances provided for in art. 72, and whether:
p.(None): I - natural person; or
p.(None): II - legal entity that has made access to genetic heritage or associated traditional knowledge solely for the purpose of scientific research.
p.(None): Art. 91. Failure to meet legal or regulatory requirements, when notified by the competent authority within the period granted:
p.(None): Minimum fine of R $ 1,000.00 (one thousand reais) and maximum fine of R $ 30,000.00 (thirty thousand reais), when dealing with a natural person.
p.(None): Minimum fine of R $ 10,000.00 (ten thousand reais) and maximum fine of R $ 200,000.00 (two hundred thousand reais), in the case of a legal entity classified as
p.(None): microenterprise, small business or traditional farmers' cooperatives with annual gross revenue equal to or less than the maximum limit established in item II
p.(None): of art. 3 of Complementary Law No. 123, of 2006.
p.(None): Minimum fine of R $ 15,000.00 (fifteen thousand reais) and maximum fine of R $ 5,000,000.00 (five million reais), for other legal entities.
p.(None): Single paragraph. The fine sanction may be substituted for the warning, when the circumstances provided for in art. 72.
p.(None): Section IV
p.(None): Administrative procedure for investigating violations
p.(None): Art. 92. Infractions against genetic heritage or associated traditional knowledge will be investigated in a specific administrative process through the
p.(None): drawing up of notice of infraction and respective terms, ensuring the right to ample defense and the adversary.
p.(None): Single paragraph. The administrative process referred to in the caput will be governed by the provisions of Decree No. 6,514, of 2008, except when
p.(None): different provision provided for in this Chapter.
p.(None): Article 93. The following are competent to inspect and investigate the administrative infractions provided for in this Decree:
p.(None): I - Ibama;
p.(None): II - the Navy Command, within the scope of Brazilian jurisdictional waters and the continental shelf; and
p.(None): III - the Ministry of Agriculture, Livestock and Supply, within the scope of access to genetic heritage for agricultural activities, under the terms of art.
p.(None): 3 of Law No. 10,883, of June 16, 2004.
p.(None): § 1 When the offense involves associated traditional knowledge, the official bodies that defend the rights of indigenous peoples, communities
p.(None): traditional farmers and traditional farmers will provide support to Ibama's inspection activities.
p.(None): § 2 Joint act of the Ministers of State for the Environment, Agriculture, Livestock and Supply and Defense will regulate the coordinated action of the
p.(None): supervisory bodies.
p.(None): Art. 94. Of the final decision issued by the bodies provided for in art. 93 CGen may appeal within twenty days.
p.(None): Art. 95. CGen act will establish criteria for the destination of the seized samples, products and instruments, referred to in § 4 of art. 27 of Law nº
p.(None): 13,123, 2015.
p.(None): Single paragraph. As long as the act referred to in the caput has not been edited, the competent authority for inspection shall make the destination, observing the provisions
p.(None): in Decree No. 6,514, of 2008.
p.(None): CHAPTER VII
p.(None): THE NATIONAL BENEFIT SHARING FUND AND THE NATIONAL BENEFIT SHARING PROGRAM
p.(None): Art. 96. The National Benefit Sharing Fund - FNRB, established by Law No. 13,123, of 2015, linked to the Ministry of the Environment, is of a nature
p.(None): financial and is intended to support actions and activities aimed at enhancing the genetic heritage and associated traditional knowledge and promoting their use of
p.(None): sustainable way.
p.(None): § 1 The FNRB's revenue comprises:
p.(None): I - appropriations enshrined in the annual budget law and their additional credits;
p.(None): II - donations;
p.(None): III - amounts collected with the payment of administrative fines imposed due to non-compliance with Law No. 13,123, of 2015;
p.(None): IV - external financial resources arising from contracts, agreements or covenants, especially reserved for the Fund's purposes;
p.(None): V - contributions made by users of genetic heritage or associated traditional knowledge to the National Benefit Sharing Program;
p.(None): VI - amounts arising from the sharing of benefits; and
p.(None): VII - other revenues that may be allocated to it.
p.(None): § 2 The monetary resources deposited in the FNRB resulting from the economic exploitation of finished product or reproductive material arising from access to
p.(None): associated traditional knowledge will be used exclusively for actions, activities and projects for the benefit of holders of traditional knowledge
p.(None): associated companies.
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| access to information | Access to information |
| alcoholic | alcoholism |
| authority | Relationship to Authority |
| criminal | criminal |
| emergencyXsituation | patients in emergency situations |
| employees | employees |
| faith | Religion |
| family | Motherhood/Family |
| genetic heritage | genetic heritage |
| hunger | Food Insecurity |
| indigenous | Indigenous |
| intellectual rights | investors/intellectual rights |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| property | Property Ownership |
| race | Racial Minority |
| single | Marital Status |
| substance | Drug Usage |
| threat | Threat of Stigma |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
capacity
consent
cultural
exploit
justice
protect
protection
Applicable Type / Vulnerability / Indicator Overlay for this Input