Provisional Measure No. 2,126-10, Of 27 March 2001

Original Language Title: Medida Provisória nº 2.126-10, de 27 de Março de 2001

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Provisional measure no. 2,126-10, of 27 MARCH 2001 Regulates the item II of § 1 and § 4 of art. 225 of the Constitution, the arts. 1st, 8th, subclause "j", "c") (10, 15 and 16, sub-paragraphs 3 and 4 of the Convention on biological diversity, rules on access to the genetic heritage, protection and access to associated traditional knowledge, the distribution of benefits and access to technology and the transfer of technology to its conservation and use, and other matters.
The PRESIDENT of the REPUBLIC, in the use of the role that gives the art. 62 of the Constitution, adopts the following provisional measure, with force of law: chapter I GENERAL PROVISIONS Art. 1 This interim measure provides for the goods, rights and obligations relating to access to genetic heritage existing component in the national territory, on the continental shelf and in the exclusive economic zone, to associated traditional knowledge and relevant to conservation of biological diversity, the integrity of the genetic patrimony of the country, the use of its components and the fair and equitable sharing of benefits derived from their exploitation and on access to technology and transfer of technology for the conservation and use of biological diversity.
(1) access to component of genetic heritage for scientific research and technological development, bioprospecting or conservation, aiming at their industrial application or otherwise, shall be in the form of this provisional measure, without prejudice to the rights of property or intangible material relating to the genetic heritage component accessed or about the place of their occurrence.
(2) the owners and holders of assets and rights referred to in this article shall be ensured, in the form of this provisional measure, the fair and equitable sharing of the benefits derived from access to genetic heritage and associated traditional knowledge.
§3 access to genetic heritage existing component on the continental shelf shall observe the provisions of law No. 8617, of 4 January 1993.
Art. 2nd the exploitation of genetic heritage existing in the country will only be made subject to authorisation or permission of the Union and will have its use, commercialization or exploitation for any purpose subject to supervision, in accordance with and subject to the conditions set out in this provisional measure.
Sole paragraph. It is owned by the genetic heritage existing in their goods, as well as in natural resources found on the continental shelf and in the exclusive economic zone.
Art. 3 This provisional measure shall not apply to the whole or part of human beings, including their genetic components.
Art. 4 is preserved the Exchange and dissemination of components of the genetic heritage and associated traditional knowledge practiced among indigenous communities and local communities among themselves, for their own benefit and based on customary practice.
Art. 5th it is forbidden the access to genetic heritage for harmful practices to the environment and to human health and to the development of biological and chemical weapons.
Art. 6 at any time, and there is solid scientific evidence of a risk of serious and irreversible damage to biological diversity, arising from activities carried out in the form of this provisional measure, the Government, through the organ referred to in art. 11, on the basis of technical advice and with criteria of proportionality, will adopt measures to prevent the damage, and may even stop the activity, in the form of regulation, respected the competence of the organ responsible for biosafety of genetically modified organisms.
CHAPTER II DEFINITIONS Art. 7 in addition to the concepts and definitions contained in the Convention on biological diversity, shall be deemed for the purposes of this interim measure: I-genetic patrimony: information of genetic origin, contained in whole or in part of specimen plant, fungal, microbial or animal substances from metabolism of these living beings and of extracts obtained of these living organisms or dead, found in in situ conditions , including domesticated, or kept in ex situ collections, since collected in in situ conditions, on the national territory, on the continental shelf or the exclusive economic zone;
II-associated traditional knowledge: information or individual or collective practice of indigenous community or local community, with real or potential value associated with the genetic heritage;
III-the local community: human group, including remnants of quilombo communities, distinguished by its cultural conditions, that traditionally organizes itself for successive generations and own customs, and which preserves its social and economic institutions;
IV. access to genetic heritage: component sampling of genetic heritage for scientific purposes, research, technological development, bioprospecting, conservation, aiming at their industrial application or otherwise;
V-access to associated traditional knowledge: information retrieval on individual or collective knowledge or practice associated with the genetic heritage, of the indigenous community or local community, for scientific purposes, of research and of technological development, aiming at their industrial application or otherwise;
I saw access to technology and technology transfer: realization of actions that have as their objective the access, the development and transfer of technologies for the conservation and use of biological diversity or the genetic heritage or associated traditional knowledge;
VII-bioprospecting: exploratory activity to identify components of the genetic heritage and associated traditional knowledge information, with potential for commercial use;
VIII-endangered species: species at high risk of disappearing in the wild in the near future, so recognized by the competent authority;
IX-domesticated species: species in the process of evolution has influenced the human being to answer your needs, being here included species, varieties and breeds at different stages of domestication;
X-access authorization: instrument issued by the body art. 11 of this provisional measure that allows, under specific conditions, access to component sample of genetic heritage and associated traditional knowledge;
XI – terms of transfer of Material: accession instrument to be signed by the addressee prior to the shipment of any sample of genetic heritage component, with or without commercial purpose;
XII-contract of use of genetic heritage and benefits ' sharing: multilateral legal instrument that qualifies the parties, object, and the conditions of access and referral of part of the genetic heritage and associated traditional knowledge, as well as the conditions of distribution of benefits.
CHAPTER III PROTECTION of the ASSOCIATED TRADITIONAL KNOWLEDGE. 8. The traditional knowledge of the indigenous communities and local communities associated with the genetic heritage will be protected by this interim injunction against the use and illicit exploitation and other harmful or unauthorized actions by the art. 11. (1) the State recognizes the right of indigenous communities and local communities have to decide about the use of their traditional knowledge associated with the genetic heritage of the country, in terms of this provisional measure and its regulation.
(2) the traditional knowledge associated to genetic heritage that this interim measure is part of the Brazilian cultural heritage.
(3) traditional knowledge associated to genetic heritage may be subject to registration, as it has in the regulation.
§ 4 the protection granted by this interim measure cannot be interpreted in such a way as to impede the preservation, use and development of traditional knowledge of indigenous communities or local communities.
§ 5 the protection now established shall not affect, impair or limit any other form of intellectual property rights.
Art. 9 indigenous communities and local communities that create, develop, hold, retain or preserve traditional knowledge associated to genetic heritage, is guaranteed the right to:-I have indicated the origin of access to traditional knowledge in all publications, uses, and disclosures;
II – prevent unauthorized third parties from using, carry out tests, research or exploration relating to associated traditional knowledge;
III-prevent unauthorized third parties to disclose, transmit or retransmit data or information that integrate or constitute associated traditional knowledge;
IV-understand benefits, compensation or royalties by economic exploitation by third parties, directly or indirectly, of associated traditional knowledge, whose rights are of their ownership.
Sole paragraph. For the purposes of this provisional measure, any traditional knowledge associated to genetic heritage may be owned by the community, even if only an individual Member of this community, holds that knowledge.
Art. 10. The person in good faith that, until 30 June 2000, used or exploited economically any traditional knowledge in the country, shall be assured the right to continue to use or operation, free of charge, in the form and under the conditions above.

Sole paragraph. The rights conferred in this article may only be assigned together with the business or company, or part of this that has a direct relation with the use or exploitation of knowledge, for sale or lease.
CHAPTER IV INSTITUTIONAL Art ASSIGNMENTS. 11. The Executive power will create an Interministerial Council, linked to the Civil House of the Presidency of the Republic, composed of representatives of the agencies holding jurisdiction over the various actions of this provisional measure, with the following purposes:-I grant permission to access the sample component of genetic heritage existing in-situ conditions, on the national territory, on the continental shelf and in the exclusive economic zone;
II-grant authorization of access to associated traditional knowledge, subject to prior informed consent of its holders;
III-monitor, in conjunction with federal agencies, the activities of the access component of the genetic heritage and associated traditional knowledge, in the form of art. 29;
IV-grant permission for shipment of sample of component of the genetic heritage and associated traditional knowledge for national institution, whether public or private, or institution headquartered abroad;
V-monitor, in conjunction with federal agencies, any shipment of sample of component of the genetic heritage and associated traditional knowledge, in the form of art. 29;
VI-monitor and evaluate access to technology and transfer of technology for the conservation and use of genetic heritage and associated traditional knowledge;
VII-disclose lists of species of Exchange made easy in international agreements, including on food security, of which the Country is a signatory, according to the sole paragraph of art. 16 of this provisional measure;
VIII-to create and maintain database to record information obtained during the field sample collection of genetic heritage component;
IX-to create and maintain database to record information about the associated traditional knowledge;
X-create, maintain, and disseminate a database to record information about all access authorizations and shipment of sample of component of the genetic heritage and associated traditional knowledge;
XI-grant to public or private national institution engaged in research and development activity in the biological and related areas, and the National University, public or private, special access authorization, with the duration of up to two years, renewable for equal periods;
XII-accredit national public institution of research and development, delegating him, by agreement, the power to authorize the shipment of sample of the genetic heritage component for national institution, whether public or private, or institution headquartered abroad, in compliance with the requirements of art. 16 of this provisional measure;
XIII-delegate, provided for in the preceding paragraph, the national public institution of research and development in the same subparagraph, competent to, when appropriate, sign, on behalf of the caput of this article, the contract of use of genetic heritage and benefits ' sharing;
XIV-accredit public and private national institution, by agreement, be depository of representative sample of faithful component of the genetic patrimony to be forwarded to national institution, whether public or private, or headquartered abroad.
Art. 12. The Inter-Ministerial Council which deals with the previous article, will have its structure and operation arranged in specific Decree of the Executive power.
Chapter V of the CONSIGNMENT and access Art. 13. Access to genetic heritage existing component in in situ conditions, on the national territory, on the continental shelf and in the exclusive economic zone and the associated traditional knowledge shall be by sample collection and information, respectively, and will only be allowed to national institution, whether public or private, carrying out research and development activities in the biological and related areas under regulation.
(1) access to samples of genetic heritage and associated traditional knowledge may only occur after obtaining the access authorization by the organ referred to in art. 11. (2) the access authorization is subject to the payment of fees and compliance with other legal and regulatory requirements.
§3 access to samples of genetic heritage, in-situ conditions, and to associated traditional knowledge may only occur after signature of the Contract of use of genetic heritage and benefits ' sharing.
§ 4 the participation of legal entities based abroad, in sample collection of genetic heritage in situ component and the access to associated traditional knowledge will only be allowed when done in conjunction with national public institution, being the coordination of compulsory activities carried out by the latter and provided that all the institutions engaged in research and development activities in the biological and related areas.
§ 5 the research on genetic heritage components must be held preferably in the national territory.
§ 6 the authorisation of access to genetic heritage component sample of species endemic or endangered will depend on the prior consent of the competent organ.
§ 7 the authorization for the ticket in indigenous lands, to access to the sample of component of the genetic heritage and associated traditional knowledge, will depend on the prior informed consent of the indigenous community involved, heard the official indigenous body.
§ 8 the authorisation for the entry into protected areas, to access to the sample of component of the genetic heritage and associated traditional knowledge, will depend on the prior consent of the competent organ.
§ 9 the authorization to enter into a public or private area, to access to the sample of component of the genetic heritage or associated traditional knowledge, will depend on the consent of the previous holder, or the local community involved, blaming the holder of the authorization to recompense you for any damage or loss caused, duly proven.
§ 10. The authorization for the ticket in the areas essential to national security, to access to the sample of component of the genetic heritage and associated traditional knowledge, will be subject to the prior hearing of the National Defense Council.
§ 11. The authorization to enter in Brazilian jurisdictional waters for purposes of collection of samples of components of the genetic heritage, associated with traditional knowledge or not, will depend on prior informed consent of the maritime authority.
Art. 14. In cases of public interest, thus characterized by the competent authority, the ticket on Indian land, public or private area for access to genetic resources, prior informed consent of its indigenous and local communities and landowners, ensuring them the provisions of art. 21 of this provisional measure.
Sole paragraph. In the case referred to in the caput of this article, indigenous and local communities and landowners must be previously informed.
Art. 15. The ex situ collections of samples of genetic heritage should be registered by the organ that it is art. 11, within a maximum of one year to 30 June 2000, as has the regulation.
Sole paragraph. Ex-situ conservation of samples of components of the genetic heritage should be performed preferably in the national territory.
Art. 16. The shipment of any sample of genetic heritage component for receiving public or private institution, national or based abroad, will be effective from material on ex situ conditions by informing the intended use and the prior signature of the deed of transfer of Material, subject to the fulfilment of the following conditions are cumulative, in addition to others that the regulation establishing : I-representative sample deposit in depositary bank based in accredited institution, in accordance with section XIV of art. 11 of this provisional measure;
II-provision of information obtained in the field, during the collection of samples of components of the genetic heritage, to record in the database mentioned in item VIII of art. 11 of this provisional measure;
III-provision of information about the associated traditional knowledge accessed, when, for the record in the database mentioned in item IX of the art. 11 of this provisional measure, guarded sensitive aspects;
IV-provision of information, when appropriate, on access to technology and transfer of technology of dealing with the arts. 18, 19 and 20 of this provisional measure, without prejudice to the intellectual property legislation in force and the sensitive aspects provided for in the contract referred to in the caput.
(1) where there is a prospect of commercial use of product or process resulting from genetic heritage component, it will require the prior signing of the contract of use of genetic heritage and benefits ' sharing.
§ 2 the shipment of sample of the genetic heritage component of species considered Exchange made easy in international agreements, including on food security, of which the Country is a signatory, shall be effected in accordance with the conditions laid down in those agreements, kept constant requirements of the provisions of this article.

Art. 17. The shipment of any sample of genetic heritage component, with or without commercial purpose, must be preceded by the signing of deed of transfer, signed by the receiving institution and returned to the supplier.
Sole paragraph. The term Material transfer will have your model approved by regulation of this provisional measure.
CHAPTER VI access to technology and TRANSFER of TECHNOLOGY Art. 18. the institution to receive sample of component of the genetic heritage or associated traditional knowledge will facilitate the access to technology and transfer of technology for the conservation and use of the property or of this knowledge to the national institution responsible for access and by transferring component sample of genetic heritage and associated traditional knowledge, or institution for her.
Art. 19. Access to technology and technology transfer between r & d institutions, public and private, domestic and foreign-based can perform, among other activities, through: (I)-scientific research and technological development;
II-formation and training of human resources;
III exchange of information;
IV-exchange among national research institutions and research institutions with headquarters abroad;
V-infrastructure consolidation of scientific research and technological development;
VI-Economic exploitation, in partnership, of processes and products derived from the use of genetic heritage component; and VII-establishment of technology-based joint ventures.
Art. 20. The companies that, in the process of ensuring access to technology and transfer of technology to national institutions, public or private, responsible for the access and transfer of sample of component of genetic heritage and associated traditional knowledge, invest in research and development activities in the country will do justice to tax incentives for technological training of industry and agriculture , and the other instruments of stimulus, in the form of relevant legislation.
CHAPTER VII BENEFITS ' SHARING Art. 21. The benefits arising from economic exploitation of a product or process developed from genetic heritage component sample, obtained by national institution or institution headquartered abroad, shall be allocated in a fair and equitable between the Union and the Contracting Parties, as it has in the regulation.
§1 When the benefits contemplated in the caput of this article arise from economic exploitation of genetic heritage accessed in indigenous lands or in the local community, their community will live up the percentage of allocations.
§ 2 in the case of the sample of the component of genetic heritage have been accessed in the area of property of State, Municipality or private, is granted to the holder of the percentage area of the benefits mentioned in the caput of this article, the title of incentive for conservation of genetic heritage, in the form of regulation.
Art. 22. Indigenous communities or local communities will do justice to percentage of benefit arising from the use of associated traditional knowledge, information obtained in these communities.
Art. 23. The benefits arising from economic exploitation of genetic heritage accessed by national institution or institution headquartered abroad, to be divided among the Contracting Parties, in a fair and equitable, may constitute, among others, of: (I)-Division of profits and royalties arising from economic exploitation of processes and products developed from genetic heritage component sample;
II-access to and transfer of technology;
III-licensing, free of charge, products and processes; and IV-human resources training.
Art. 24. The economic exploitation of a product or process developed from genetic heritage component sample, which is accessed in accordance with the provisions of this provisional measure, will subject the infringer to payment of severance pay corresponding to at least 20% of the gross revenues from the sale of a product or of the royalties obtained from third parties for the offender, in the event of a process or licensing use of technology , or not protected by intellectual property rights, without prejudice to the administrative penalties in the form of this provisional measure and criminal penalties provided for in current legislation.
Art. 25. the contract of use of genetic heritage and benefits ' sharing, multilateral legal instrument should indicate and qualify with clarity the Contracting Parties, namely: (I)-on one side: the Federal Union;)
b) the owner of the area, public or private, or the representative of the indigenous community and indigenous official organ, or the representative of the local community;
II-on the other hand: a) the national institution authorized to access; and (b)) the receiving institution.
Art. 26. Are essential clauses of the contract of use of genetic heritage and benefits ' sharing, which have about: I-object, its elements, quantification of sample and intended use;
II. term of duration;
III-form of fair and equitable sharing of benefits;
IV-rights and responsibilities of the parties;
V-intellectual property;
VI-conditions of access to technology and transfer of technology;
VII-withdrawal;
VIII-penalties;
IX-Forum.
CHAPTER VIII of ADMINISTRATIVE SANCTIONS Art. 27. the administrative violation against the genetic heritage or associated traditional knowledge every action or omission that violates the rules set out in this provisional measure.
(1) The administrative infractions will be punished in the manner established in the regulation of this provisional measure, subject to the following penalties: (I)-warning;
II-fine;
III-seizure of the products and of components of the genetic heritage;
IV-suspension of sale of the product;
V-embargo of the activity;
VI-partial or total prohibition of the establishment, activity or undertaking;
VII. suspension of registration, license or permission legally required;
VIII-cancellation of registration, license or permit legally required;
IX-loss or restriction of incentives and tax breaks granted by the Government;
X-loss or suspension of participation in official establishments financing lines of credit;
XI-intervention in the establishment;
XII-ban on contract with the Public Administration for a period of up to five years.
(2) the material or product and the instruments referred to in the previous paragraph will have their allocation set by the competent body, including its destruction.
(3) the penalties laid down in this article shall be applied by the Agency contemplated in art. 11, in the form of procedure established in the regulation of this provisional measure, without prejudice to the applicable criminal or civil penalties.
§ 4 The penalties contemplated in item II of paragraph 1 of this article shall be refereed by the competent authority according to the gravity of the infringement and in the form of regulation, and may range from 200.00 R$ (200 dollars) to 100,000.00 R$ (100,000 dollars), in the case of an individual.
§ 5 If the infringement is committed by a legal person, or with your contest, the fine will be $ 10000.00 (10000) R$ the R$ 50,000,000.00 (50 million dollars), arbitrated by the competent authority, in accordance with the gravity of the infringement, in the form of regulation.
CHAPTER IX Final Provisions Art. 28. the granting of industrial property rights by the competent bodies, about process or product obtained from genetic heritage component sample, is subject to the observance of this provisional measure and the applicant to inform the source of the genetic material and associated traditional knowledge, where appropriate.
Art. 29. The monitoring, interception and seizure of genetic heritage component sample accessed in accordance with the provisions of this provisional measure shall be carried out by federal agencies, in accordance with that regulation and are available yet, such activities are decentralized through covenants.
Art. 30. The provision of the services referred to in this provisional measure will be charged return, whose value and gathering process will be set out in Act of the holder of the Federal public administration that are bound to such services.
Sole paragraph. The resources of the consideration of this article shall constitute my own recipe of the art. 11, the implementation of which will be for him set in resolution.
Art. 31. The share of profits and royalties, due to Union, resulting from the economic exploitation of processes or products developed from genetic heritage component sample as well as the fines and indemnities of this provisional measure shall be intended for the National Environmental Fund, created by law No. 7797, of 10 July 1989, the Naval Background , created by Decree No. 20923, of 8 January 1932, and the National Fund for scientific and technological development, created by Decree-Law No. 719 of 31 July 1969 and reinstated by law No. 8172, of 18 January 1991, in the form of regulation.

Sole paragraph. The resources in this article shall be used in the conservation of biological diversity, to promote the sustainable use of its components, in the promotion of scientific research, technological development associated with the genetic heritage and the training of human resources.
Art. 32. The Executive power will regulate this provisional measure until December 30 2000.
Art. 33. the provisions of this provisional measure shall not apply to matters regulated by law No. 8974, 5 January 1995.
Art. 34. Get convalidados the acts performed on the basis of provisional measure no. 2,126-9, of 23 February 2001.
Art. 35. This provisional measure shall enter into force on the date of its publication.
Brasília, 27 March 2001; 180 degrees of independence and 113da Republic.
FERNANDO HENRIQUE CARDOSO, Pedro Parente

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