Decree No. 3945, Of 28 September 2001

Original Language Title: Decreto nº 3.945, de 28 de Setembro de 2001

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Decree No. 3945, of 28 SEPTEMBER 2001 Defines the composition of the genetic heritage management Council and lays down rules for its functioning, through regulation of the arts. 10, 11, 12, 14, 15, 16, 18 and 19 of the provisional measure no. 2,186-16, of August 23, 2001 that 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 powers conferred. 84, subparagraphs IV and VI, paragraph a, of the Constitution, d and c r e t a: Art. 1 this Decree defines the composition of the genetic heritage management Council and lays down rules for its functioning, through regulation of the arts. 10, 11, 12, 14, 15, 16, 18 and 19 of the provisional measure no. 2,186-16, of August 23 2001.
Art. 2 the genetic heritage management Council shall be composed of one representative and its alternate of the following organs and entities of the Federal Public Administration, which have competence over the matters object of provisional measure no. 2,186-16, 2001: I-Ministry of environment;
II-Ministry of science and technology;
III-Ministry of health;
IV-Ministry of Justice;
V-Ministry of agriculture, livestock and food supply;
VI-Ministry of defence;
VII-Ministry of culture;
VIII-Ministry of Foreign Affairs;
IX-Ministry of development, industry and foreign trade;
X-Brazilian Institute of environment and renewable natural resources-IBAMA;
XI-Instituto de Pesquisas Jardim Botânico do Rio de Janeiro;
XII-Conselho Nacional de Desenvolvimento Científico e Tecnológico-CNPq;
XIII-Instituto Nacional de Pesquisas da Amazônia-INPA;
XIV-Brazilian Agricultural Research Corporation-Embrapa;
Xv-Oswaldo Cruz Foundation-Fiocruz;
XVI-Instituto Evandro Chagas;
XVII-National Indian Foundation Funai-;
XVIII-Instituto Nacional de Propriedade Industrial – INPI;
Xix-Palmares Cultural Foundation.
(1) the Management Board shall be chaired by a representative of the Environment Ministry and, in their impediments or gaps, by the respective Deputy.
(2) the members of the Management Board, holders and alternates shall be appointed by the legal representatives of the ministries and entities of the Federal Public Administration that are, and will be designated in Act of the Minister of State for the environment.
(3) the term of Office of a member of the Management Board shall not be paid and your exercise is considered relevant public service.
§ 4 the Management Board shall meet in ordinary character once a month and, extraordinarily, at any time, upon convocation of its President, or the absolute majority of its members, in this case through written document, together with the agenda.
§ 5 the frequency referred to in paragraph 4 may be amended by decision of the Management Board.
§ 6 the Member who miss two meetings in a row or three interspersed without the corresponding substitutions by alternate, will be removed from the Management Board.
§ 7 the Chairman of the Management Board may invite experts to participate in plenary meeting or thematic Chamber to support decision-making.
Art. 3 pursuant to provisional measure no. 2,186-16, 2001, it is the genetic heritage management Council, met their deliberative and normative nature: I-to coordinate the implementation of policies for the management of genetic heritage;
II-establish: a) technical standards, relevant to the management of genetic heritage;
b) criteria for the authorisation of access and referral;
c) guidelines for the preparation of Contract of use of genetic heritage and benefits ' sharing;
d) criteria for the creation of a database for the registration of information on associated traditional knowledge;
III-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;
IV-discuss: a) authorization of access and referral component sample of genetic heritage, through prior informed consent of its holder;
b) authorization of access to associated traditional knowledge, subject to prior informed consent of its holder;
c) special authorization of access and remittance of genetic heritage component sample, with the duration of up to two years, renewable for equal periods, to a public or private national institution engaged in research and development activity in the biological and related areas, and the National University, public or private;
d) special authorization of access to associated traditional knowledge, with the duration of up to two years, renewable for equal periods, to a public or private national institution engaged in research and development activity in the biological and related areas, and the National University, public or private;
e) accreditation of national public institution of research and development, or federal public management institution, to authorize another national institution, whether public or private, engaged in research and development activity in the biological and related areas, the access component sample of genetic heritage and associated traditional knowledge, as well as the mail component sample of genetic heritage for national institution whether public or private, or institution headquartered abroad;
f) accreditation of national public institution to be faithful trustee of genetic heritage component sample;
g) accreditation of institutions for non-compliance with the provisions of the provisional measure no. 2,186-16, 2001, and this Decree;
V-give consent to contracts of use of genetic heritage and benefits ' sharing with regard to the attendance of the requirements in provisional measure no. 2,186-16, 2001;
VI-to promote discussions and public consultations on the themes covered by provisional measure no. 2,186-16, 2001;
VII-working as a higher instance of recourse against the decision of accredited institution and acts arising from the application of the provisional measure no. 2,186-16, 2001;
VIII-to approve its internal regulations.
Sole paragraph. The genetic heritage management Council shall exercise its powers in accordance with the provisions of the Convention on biological diversity, the provisional measure no. 2,186-16, 2001, and this Decree.
Art. 4 the decisions of the Management Board shall be taken by an absolute majority of its members.
Sole paragraph. The President of the management board the casting vote.
Art. 5 of the deliberations of the Board of Management appeal to the Plenary, whose decision will be made by two-thirds of its members.
Sole paragraph. Are indisputable the deliberations of the plenary of the Management Board to decide the appeal.
Art. 6 in the deliberations in cases involving the direct participation of Ministry or entity represented on the Management Board, the Member will not be entitled to vote.
Art. 7 Is created, in the structure of the Ministry of environment, the Department of genetic heritage, who shall exercise the function of Executive Secretariat of the Management Board, and shall have the following powers, among others:-to implement the resolutions of the Board of management;
II-promoting education and the processing of the dossiers to be submitted to the Management Board;
III-support to accredited institutions;
IV-issue, in accordance with resolution of the Management Board and on its behalf, authorization of access and remittance of genetic heritage component sample in the national territory, on the continental shelf and in the exclusive economic zone, as well as Authorization of access to associated traditional knowledge;
V-issue, in accordance with resolution of the Management Board and on its behalf, special authorization of access and remittance of genetic heritage component sample, and authorization of access to associated traditional knowledge, with the duration of up to two years, renewable for equal periods, to a public or private national institution engaged in research and development activity in the biological and related areas and the National University whether public or private;
VI-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;
VII-promote, in accordance with resolution of the Management Board and on its behalf, the accreditation of national public institution of research and development, or federal public management institution, to authorize national institution, whether public or private, to access sample of component of genetic heritage and associated traditional knowledge, as well as to send sample of genetic heritage component the national institution whether public or private, or institution headquartered abroad, in compliance with the requirements of art. 19 of provisional measure no. 2,186-16, 2001;
VIII-promote, in accordance with resolution of the Management Board and on its behalf, the accreditation of national public institution to be faithful trustee of genetic heritage component sample;

IX-descredenciar institutions, in accordance with resolution of the Management Board and on its behalf, for compliance with the provisions of the provisional measure no. 2,186-16, 2001, and this Decree;
X-register the contracts of use of genetic heritage and benefits ' sharing, after the consent of the Management Board;
XI-spread exchange facilitated species list of international agreements, including on food security, of which the Country is a signatory, according to §2 of art. 19 of provisional measure no. 2,186-16, 2001;
XII-create and maintain: the registration of ex situ collections), as provided for in art. 18 of provisional measure no. 2,186-16, 2001;
b) database to record information obtained during sample collection of genetic heritage component;
c) database of authorizations of access and shipment of sample of component of the genetic heritage and associated traditional knowledge access, to the terms of transfer of Material and contracts of use of genetic heritage and benefits ' sharing;
XIII-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.
Art. 8 for obtaining authorization of access and shipment of sample of component of the genetic heritage and associated traditional knowledge access to national institution, whether public or private, engaged in research and development activity in the biological and related areas, what are the headings "a" and "b" of item IV of the art. 11 of provisional measure no. 2,186-16, 2001, you should forward the request to the Board of Management or the accredited institution, taking into account at least the following requirements: (I)-attestation of its activities in research and development in biological and related areas;
II-technical qualification for performance of activities of collection and shipment of sample of the genetic heritage or component for access to associated traditional knowledge;
III-structure available for the sample handling component of the genetic patrimony;
IV-research project that describes the activity component sample collection of genetic heritage or of access to associated traditional knowledge, including information about the intended use;
V-prior informed consent to admission in the areas to be sampled by the expedition, in the form set out in §§ 8 and 9 of the art. 16 of provisional measure no. 2,186-16, 2001;
VI-destination of samples of components of the genetic heritage to be accessed.
Sole paragraph. The research project referred to in item (IV) of this article shall contain: (I)-history, background, definition of objectives, methods and expected results from the sample or information being accessed;
II-detailed itinerary in the national territory, indicating the planned dates for the beginning and ending of the activity;
III-breakdown of the type of material or information to be accessed and approximate quantification of specimens to be obtained;
IV. indication of the sources of funding, of the respective amounts and Division of the responsibilities of each party;
V-curriculum vitae of investigators and technicians involved, if they are not available at the lattes platform, maintained by the CNPq.
Art. 9 to obtain special authorization of access and shipment of sample of component of the genetic heritage and associated traditional knowledge access to national institution, whether public or private, engaged in research and development activity in the biological and related areas, of which deal with points "c" and "d" of item IV of the art. 11 of provisional measure no. 2,186-16, 2001, you should forward the request to the Board of management, taking into account at least the following requirements: (I)-attestation of its activities in research and development in biological and related areas;
II-technical qualification for performance of the activities of collection and shipment of sample of component of the genetic patrimony;
III-structure available for the sample handling component of the genetic patrimony;
IV-portfolio of projects developed by the institution, highlighting those who will benefit by the authorization requested, including information on the intended use;
V-prior informed consent to admission in the areas to be sampled by collecting expeditions in the form established in § 11 of the art. 16 of provisional measure no. 2,186-16, 2001;
VI-fate of genetic material to be accessed and an indication of the technical team and the infrastructure available to manage the terms of transfer of Material to be signed prior to the shipment of sample to another national institution, whether public or private, or based overseas and the respective contracts of use of genetic heritage and benefits ' sharing, when applicable.
Sole paragraph. The research projects included in the portfolio referred to in item (IV) of this article, directly benefited by the request, shall contain: (I)-history, background, definition of objectives, methods and expected results from the sample or information being accessed;
II-detailed itinerary in the national territory, indicating the planned dates for the beginning and end of the activity, to be forwarded to the Management Board;
III-breakdown of the type of material or information to be accessed and approximate quantification of specimens to be obtained;
IV. indication of the sources of funding, of the respective amounts and Division of the responsibilities of each party;
V-curriculum vitae of investigators and technicians involved, if they are not available at the lattes platform, maintained by the CNPq.
Art. 10. For the accreditation of national public institution of research and development or federal public management institution to authorize another national institution, whether public or private, engaged in research and development activity in the biological and related areas, to access and mail component sample of genetic heritage and associated traditional knowledge that access treat the items 1 and 2 of paragraph "e" of sub-item IV of art. 11, provisional measure no. 2,186-16, 2001, the Management Board shall receive request that meets at least the following requirements: (I)-attestation of its activities in research and development in biological and related areas or in the area of management;
II-list of activities and projects in development related to the actions of the provisional measure no. 2,186-16, 2001;
III-available infrastructure and technical team to act: the) analysis of application and issuance to third parties, for marketing authorization: 1. access to genetic heritage component sample in situ conditions existing in the national territory, on the continental shelf and in the exclusive economic zone, through prior informed consent of its holders;
2. access to associated traditional knowledge, subject to prior informed consent of its holders;
3. shipment of sample of the genetic heritage component for national institution, whether public or private, or institution headquartered abroad;
b) in monitoring, 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;
c) in creating and maintaining: 1. register of ex situ collections, as provided for in art. 18 of provisional measure no. 2,186-16, 2001;
2. database to record information obtained during sample collection of genetic heritage component;
3. the database of authorizations of access and Referral, to the terms of transfer of Material and contracts of use of genetic heritage and benefits ' sharing;
d) on disclosure of list of access Authorizations and Shipment, of the terms of transfer of Material and contracts of use of genetic heritage and benefits ' sharing;
and monitoring and implementation) of the terms of transfer of Material and contracts of use of genetic heritage and benefits ' sharing pertaining to processes authorized by it;
f) in preparing and forwarding, Management Board, annual report of the activities carried out and the database copy to the Executive Secretariat of the Management Board.
Art. 11. For the accreditation of national public institution of research and development as a faithful sample component depository genetic patrimony of the item "f" of item IV of the art. 11, provisional measure no. 2,186-16, 2001, the Management Board shall receive request that meets at least the following requirements: (I)-attestation of its activities in research and development in biological and related areas;
II-an indication of the available infrastructure and capacity for conservation ex situ conditions, of samples of components of the genetic heritage;
III-attestation of ability of the technical team responsible for conservation activities;
IV-description of the methodology and material employed for the conservation of species upon which the institution will assume responsibility as a faithful trustee;
V-indication of budget availability for maintenance of the Collections.

Art. 12. The collection of activity component of the genetic heritage and associated traditional knowledge access, which contributes to the advancement of knowledge and that is not associated to bioprospecting, when involving the participation of foreign legal entity, shall be authorised by the CNPq, observed the determination of provisional measure no. 2,186-16, 2001, and the current legislation.
Sole paragraph. The authorization referred to in the caput of this article will notice the technical standards defined by the Management Board, which shall exercise supervision of these activities.
Art. 13. The internal regulations of the genetic heritage management Council will have, at least, on the way to his performance, record of its deliberations and the archiving of their actions.
Art. 14. This Decree shall enter into force on the date of its publication.
Brasília, 28 September 2001; 180 degrees of independence and 113 of the Republic.
FERNANDO HENRIQUE CARDOSO Johaness Eck José Serra Carlos Américo Pacheco José Sarney Filho

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