Source: https://www.global-regulation.com/translation/brazil/2903708/provisional-measure-no.-2%252c186-16%252c-of-august-23-2001.html
Timestamp: 2019-12-09 16:34:16
Document Index: 623871564

Matched Legal Cases: ['§ 1', '§ 4', 'art. 225', 'art. 62', 'Art. 1', 'Art. 7', 'Art. 9', 'Art. 10', 'Art. 11', 'Art. 14', 'art. 11', 'art. 18', 'Art. 15', 'art. 10', '§2', 'art. 19', 'art. 18', 'Art. 16', '§ 3', 'art. 11', '§ 4', '§ 5', '§ 9', '§ 2', '§ 6', 'art. 231', 'Art. 19', '§ 3', 'art. 16', 'art. 14', 'art. 15', 'Art. 22', 'Art. 25', 'Art. 28', 'Art. 30', 'Art. 33', 'Art. 37']

Machine Translation of "Provisional Measure No. 2,186-16, Of August 23 2001" (Brazil)
Provisional Measure No. 2,186-16, Of August 23 2001
Original Language Title: Medida Provisória nº 2.186-16, de 23 de Agosto de 2001
Provisional measure no. 2,186-16, of AUGUST 23 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 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: I-access to genetic heritage existing component in the national territory, on the continental shelf and in the exclusive economic zone for the purpose of scientific research, bioprospecting or technological development;
II-to access to traditional knowledge associated to genetic heritage, relevant to the conservation of biological diversity, the integrity of the genetic patrimony of the country and the use of its components;
III-the fair and equitable sharing of the benefits derived from the exploitation of genetic heritage components and the associated traditional knowledge; and IV-to 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, bioprospecting or technological development will 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.
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 all or part of specimen plant, fungal, microbial or animal, in the form of molecules and substances from metabolism of these living beings and of extracts obtained from these live or dead organisms , found in in situ conditions, including domesticated, or kept in ex situ collections, since collected in in situ conditions in national territory, on the continental shelf or the exclusive economic zone;
V-access to associated traditional knowledge: information retrieval on knowledge or individual or collective practice, associated with the genetic heritage, of the indigenous community or local community, for the purposes of scientific research, bioprospecting or technological development, aiming at their industrial application or otherwise;
I saw access to technology and transfer of technology: action that has as its objective the access, the development and transfer of technology for the conservation and use of biological diversity or technology developed from sample of component of genetic heritage or associated traditional knowledge;
VII-bioprospecting: exploratory activity to identify components of the genetic heritage and associated traditional knowledge, with potential for commercial use;
IX-domesticated species: that in the process of evolution has influenced the human being to meet your needs;
X-access authorization and referral: document that allows, under specific conditions, the access to genetic heritage component sample and your shipment to the receiving institution and the access to associated traditional knowledge;
XI-special authorization of access and Referral: document that allows, under specific conditions, the access to genetic heritage component sample and your shipment to the receiving institution and the access to associated traditional knowledge, with the duration of up to two years, renewable for equal periods;
XII – terms of transfer of Material: accession instrument to be signed by the addressee prior to the shipment of any sample of genetic heritage component, indicating, where applicable, if there was access to associated traditional knowledge;
XIII-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 for benefit sharing;
XIV-ex situ condition: sample component maintenance of genetic heritage outside of their natural habitat, living or dead Collections.
Art. 9 to the indigenous community and the local community that create, develop, hold or retain 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: the) use, perform tests, research or exploration relating to associated traditional knowledge;
III – perceiving benefits by economic exploitation by third parties, directly or indirectly, of associated traditional knowledge, whose rights are of their ownership under this provisional measure.
INSTITUTIONAL competencies and RESPONSIBILITIES Art. 10. Is created, within the Ministry of the environment, the genetic heritage management Council, deliberative and normative character, made up of representatives of organs and entities of the Federal Public Administration who hold jurisdiction over the various actions of this provisional measure.
Art. 11. the Management Board:-coordinate the implementation of policies for the management of genetic heritage;
II-establish: a) technical standards;
c) special authorization of access and remittance of genetic heritage component sample to the national institution, whether public or private, engaged in research and development activity in the biological and related areas, and the National University, public or private, with the duration of up to two years, renewable for equal periods in accordance with regulation;
V-give consent to contracts of use of genetic heritage and benefits ' sharing how to meet the requirements laid down in this provisional measure and in its rules;
VI-to promote discussions and public consultations on the themes of this provisional measure;
VII-working as a higher instance of recourse against the decision of accredited institution and acts arising from the application of this provisional measure;
(2) the Management Board may organize into thematic Chambers, to support decisions of the plenary.
Art. 14. It will be up to the accredited institution what are the numbers 1 and 2 of paragraph "e" of sub-item IV of art. 11 of this provisional measure one or more of the following attributions, in compliance with the guidelines of the Board of management: I-analyze application and send to third parties, access authorization: a) the component of the genetic heritage existing in-situ conditions in national territory, on the continental shelf and in the exclusive economic zone, through prior informed consent of its holders;
II-monitor, in conjunction with federal agencies, or by agreement with other institutions, the activities of access and shipment of sample of component of the genetic heritage and associated traditional knowledge access;
III-create and maintain: the registration of ex situ collections), as provided for in art. 18 of this provisional measure;
IV – disseminate periodically, list of Access authorizations and Shipment, of the terms of transfer of Material and contracts of use of genetic heritage and benefits ' sharing;
V-monitor the implementation of the terms of transfer of Material and contracts of use of genetic heritage and benefits ' sharing regarding authorized by it processes.
Art. 15. Is authorized the creation, within the Ministry of the environment, of executor who shall exercise the function of the Executive Secretariat of the Management Board, which deals with the art. 10 of this provisional measure, with the following tasks, among others:-to implement the resolutions of the Board of management;
II-support to accredited institutions;
III-issue, in accordance with resolution of the Management Board and on its behalf: a) and access authorization consignment;
IV-monitor, in coordination with other federal agencies, the activities of access and shipment of sample of component of the genetic heritage and associated traditional knowledge access;
V-accredit, in accordance with resolution of the Management Board and on its behalf, public institution of national research and development or federal public management institution to authorize national institution, whether public or private: a) the access component sample of genetic heritage and associated traditional knowledge;
VI-accredit, in accordance with resolution of the Management Board and on its behalf, national public institution to be faithful trustee of genetic heritage component sample;
VII-register the contracts of use of genetic heritage and benefits ' sharing, after the consent of the Management Board;
VIII-disclose list of Exchange made easy listed in international agreements, including on food security, of which the Country is a signatory, according to §2 of art. 19 of this provisional measure;
IX-create and maintain: the registration of ex situ collections), as provided for in art. 18;
X-disseminate periodically, list of Access authorizations and Shipment, of the terms of transfer of Material and contracts of use of genetic heritage and benefits ' sharing.
Chapter V of the CONSIGNMENT and access Art. 16. Access to genetic heritage existing component in in situ conditions in national territory, on the continental shelf and in the exclusive economic zone, and to 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 upon prior authorization, in the form of this provisional measure.
§ 3 Sub-representative sample from each population genetic heritage component accessed must be deposited ex situ condition in accredited institution as true depository of the item "f" of item IV of the art. 11 of this provisional measure, in the form of regulation.
§ 4 when there is a prospect of commercial use, the access to genetic heritage component sample in situ conditions, and to associated traditional knowledge can only occur after signature of the Contract of use of genetic heritage and benefits ' sharing.
§ 5 if identified potential economic use of product or process liable or not of intellectual protection, originated from component sample of genetic heritage and associated traditional knowledge from information, accessed based on authorization did not establish this hypothesis, the recipient institution is obliged to inform the management board or the institution where the access and referral process , for the formalization of Contract of use of genetic heritage and benefits ' sharing.
§ 9 the access authorization and remittance shall be after the prior informed consent: I-the indigenous community involved, heard the official indigenous body, when access occurs on indigenous land;
II – to the competent body, when access occurs in a protected area;
III-the proprietor of private area, when access it occur;
IV-the National Defense Council, when access if der in national security vital area;
V-maritime authority, when access if it works on Brazilian jurisdictional waters, the continental shelf and in the exclusive economic zone.
§ 2 in the case of indigenous land, observe the provisions of § 6 of art. 231 of the Federal Constitution.
Art. 19. The shipment of sample of the genetic heritage component of national institution, whether public or private, to another national institution, whether public or private, will be made from material on ex situ conditions, by means of the information on the intended use, subject to the fulfilment of the following conditions are cumulative, in addition to others that the Management Board will establish: I-representative sub-sample of deposit component of the genetic patrimony in collection maintained by accredited institution , if you have not been fulfilled the provisions of § 3 of art. 16 of this provisional measure;
II-in the case of a sample of the genetic heritage component accessed in situ conditions, before editing this provisional measure, the deposit referred to in the previous subparagraph shall be made in the form accessed, if still available, in accordance with the regulation;
III-provision of information obtained during the sample collection of genetic heritage component for registration in the database mentioned in paragraph b of item III of art. 14 and subparagraph b of item IX of the art. 15 of this provisional measure;
IV-Term subscription prior to transfer.
Art. 22. Access to technology and knowledge transfer between national research and development institution, public or private, and institution headquartered abroad, through, among other activities, through: (I)-scientific research and technological development;
IV-exchange between national research institution and research institution headquartered abroad;
VI-Economic exploitation, in partnership, product and process derived from the use of components of the genetic heritage; and VII-establishment of joint venture of technological basis.
Art. 25. The benefits arising from economic exploitation of a product or process developed from sample of genetic heritage or associated traditional knowledge, can constitute, among others, of: (I)-Division of profits;
II-royalty;
III-access and transfer of technology;
IV-licensing, free of charge, products and processes; and V-human resources training.
Art. 28. Are essential clauses of the contract of use of genetic heritage and benefits ' sharing, in the form of regulation, without prejudice to any other, which have about: I-object, its elements, quantification of sample and intended use;
III-form of fair and equitable sharing of benefits and, where appropriate, access to technology and transfer of technology;
VI-termination;
VII-penalties;
VIII-Forum in Brazil.
Sole paragraph. When the Union is a party, the contract referred to in the caput of this article shall be governed by the legal regime of public law.
CHAPTER VIII of ADMINISTRATIVE SANCTIONS Art. 30. the administrative violation against the genetic heritage or associated traditional knowledge every action or omission that violates the rules of this provisional measure and other relevant legal provisions.
III-seizure of samples of components of the genetic heritage and the instruments used in gathering or processing or of products obtained from information on associated traditional knowledge;
XII-intervention in the establishment;
XIII-ban on contract with the Public Administration for a period of up to five years.
Art. 33. The share of the profits and royalties owed to the Union, resulting from the economic exploitation of a product or process developed from genetic heritage component sample as well as the value of fines and indemnities of this provisional measure shall be intended for the National Environmental Fund, created by law No. 7797, of 10 July 1989 in the 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.
Art. 37. Are convalidados the acts performed on the basis of the provisional measure in 2,186-15, of 26 July 2001.
Brasília, August 23 2001; 180 degrees of independence and 113 of the Republic.
FERNANDO HENRIQUE CARDOSO José Gregori Ronaldo Mota Sardenberg José Serra José Sarney Filho