Decree No. 4946, 31 December 2003

Original Language Title: Decreto nº 4.946, de 31 de Dezembro de 2003

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Decree No. 4946, of 31 DECEMBER 2003.
Amending, repealing and adds devices to the Decree No. 3945, of 28 September 2001, which regulates Provisional Measure 16, 2,186-23 August 2001.
The PRESIDENT of the REPUBLIC, in the use of the role that gives the art. 84, section IV, of the Constitution, DECREES: Art. 1 Decree No. 3945, of 28 September 2001, with the following changes: "Art. 8th Can get authorisations referred to in art. 11, subparagraph IV, paragraph 1 (a) "a" and "b", of the provisional measure no. 2,186-16, 2001, the institution that meets the following requirements, among others that may be required by the Board of management: I-Proof of that:) was formed under Brazilian law;
b) carries out research and development activities in the biological and related areas;
II-technical qualifications for the performance of activities of access and shipment of sample of the genetic heritage or component of access to associated traditional knowledge, where appropriate;
................................................
V-submission of prior consents referred to in art. 16, §§ 8 and 9, the provisional measure no. 2,186-16, 2001;
I saw the presentation of prior informed consent of the indigenous or local community involved, when dealing with access to associated traditional knowledge, in accordance with the arts. 8, § 1, art. 9, item II, and art. 11, subparagraph IV, item "b", of the provisional measure no. 2,186-16, 2001;
VII-indication of the destination of samples of components of the genetic heritage or associated traditional knowledge-related information;
VIII-indication of the true depository institution accredited by the Board of Management where they will be deposited the component sub-amostras of genetic heritage;
IX-when it comes to access to scientific research, presentation of term of commitment signed by the legal representative of the institution, pledging to access genetic heritage or associated traditional knowledge only for the purpose authorized; and X-presentation of the contract of use of genetic heritage and benefits ' sharing duly signed by the parties, in the case of access to genetic heritage or associated traditional knowledge with potential economic use, as occurs in the activities of bioprospecting and technological development.
§1 when access has the purpose of scientific research, verifying the requirements of sections II and III of the caput of this article may be waived by the Board of management or accredited institution in the form of art. 14 of provisional measure no. 2,186-16, 2001.
§ 2 the research project referred to in item IV of the caput of this article shall contain: (I)-introduction, rationale, objectives, methods and expected results from the sample or information being accessed;
II. geographical location and schedule of the stages of the project, specifying the period during which the activities will be developed and, in the case of access to associated traditional knowledge, identification of indigenous communities or locations involved;
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 financing, their amounts and the responsibilities and rights of each party;
V-team identification and curriculum vitae of the researchers involved, if they are not available at the Lattes platform, maintained by the CNPq.
§ 3 the beneficiary institution for authorising this article shall forward to the Board of Management or the accredited institution in the form of art. 14 of provisional measure no. 2,186-16, 2001, reports on the progress of the project, on time limits to be laid down in the authorization of access. " (NR)
"Art. 9 you may obtain special authorizations referred to in art. 11, subparagraph IV, points (a) to "c" and "d", of the provisional measure no. 2,186-16, 2001, for scientific research without potential for economic use, the institution concerned to make the access component of the genetic heritage or associated traditional knowledge that meets the following requirements, among others that may be required by the Board of management: I-Proof of that:) was formed under Brazilian law;
b) carries out research and development activities in the biological and related areas;
II-technical qualifications for the performance of activities of access and shipment of sample of the genetic heritage or component of access to associated traditional knowledge, where appropriate;
III-structure available for the handling of samples of components of the genetic heritage;
IV-portfolio of projects and routine activities involving access and referral to genetic heritage components developed by the institution;
V-submission of prior consents referred to in art. 16, §§ 8 and 9, the provisional measure no. 2,186-16, 2001, in the case of access to genetic heritage component;
I saw the presentation of prior informed consent of the indigenous or local community involved, in compliance with the arts. 8, § 1, art. 9, item II, and art. 11, subparagraph IV, item "b", of the provisional measure no. 2,186-16, 2001, in the case of access to associated traditional knowledge;
VII-indication of the fate of the genetic material or the information concerning associated traditional knowledge and 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 headquartered abroad;
VIII-term of commitment signed by the legal representative of the institution, pledging to access genetic heritage or associated traditional knowledge solely for purposes of scientific research without potential for economic use.
§ 1 the portfolio referred to item IV of the caput of this article shall bring the summary description of the activities to be developed, as well as the projects summarized with the following minimum requirements: I-objectives, material, methods, intended use and destination of the sample or information being accessed;
II-area of field activities and, in the case of access to associated traditional knowledge, identification of indigenous communities or locations involved;
III-indication of the sources of financing;
IV-team identification and curriculum vitae of the researchers involved, if they are not available at the Lattes platform, maintained by the CNPq.
§ 2 the beneficiary institution for authorising this article shall forward to the Board of Management or the accredited institution in the form of art. 14 of provisional measure no. 2,186-16, 2001, reports whose frequency shall be fixed in the authorisation and may not exceed the period of 12 months.
(3) the report referred to in § 2 shall contain at least the following: (I)-detailed information about the progress of the projects and activities members of the portfolio;
II-an indication of the areas where the collections were held by means of geographical coordinates;
III-quantitative and qualitative listing of species or morphotypes collected in each area;
IV-copy of records of information relating to associated traditional knowledge;
V-attesting the deposit of sub-amostras in faithful depository institution accredited by the Management Board;
VI-presentation of the terms of transfer of Material;
VII-indication of funding sources, their amounts and the responsibilities and rights of each party; and VIII-preliminary results.
§ 4 the beneficiary institution for authorisation of this article may, during the term of the authorisation, enter new activities or projects in the portfolio, as long as you observe the conditions laid down in this article and, within 60 days from the beginning of the new activity or project, please report the change to the management board or the accredited institution in the form of art. 14 of provisional measure no. 2,186-16, 2001. " (NR)
Art. 2 Decree No. 3945, of 2001, goes into effect plus the following items: "Art. 9-a. You can obtain the special permit referred to in art. 11, subparagraph IV, item "c" of provisional measure no. 2,186-16, 2001, to perform the access to genetic heritage with the purpose to establish and integrate ex situ collections aimed at activities with potential for economic use, such as bioprospecting or technological development, the institution that meets the following requirements, among others that may be required by the Management Board : I-Proof of that:) was formed under Brazilian law;
b) carries out research and development activities in the biological and related areas;
II-technical qualification for performance of training activities and maintenance of ex situ collections or shipment of samples of components of the genetic heritage, when applicable;
III-structure available for the handling of samples of components of the genetic heritage;
IV-Constitution of ex situ collection from activities of access to genetic heritage;
V-submission of prior consents referred to in art. 16, §§ 8 and 9, the provisional measure no. 2,186-16, 2001;

VI-indication of the fate of the genetic material, as well as 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;
VII-signature, by the legal representative of the institution in terms of commitment by which it undertakes to access genetic patrimony only for the purpose of establishing ex situ collection; and VIII-presentation of model contract of use of genetic heritage and benefits ' sharing, to be signed with the owner of a public or private area or with a representative of the indigenous community and the official indigenous body.
(1) the model contract of use of genetic heritage that treats the item VIII of the caput of this article shall be submitted to the Management Board for approval, which will be subject to the provisions of art. 28 of provisional measure no. 2,186-16, 2001, without prejudice to other requirements that may be required by the Council.
§ 2 the project contemplated in section IV of the caput of this article shall bring the summary description of the activities to be developed, with the following minimum requirements: I-objectives, material, methods, intended use and destination of the sample to be accessed;
II-area of field activities;
III-indication of the sources of financing; and (IV) identification and curriculum vitae of the researchers involved, if they are not available at the Lattes platform, maintained by the CNPq.
§ 3 the institution benefited by special permit referred to in this article shall submit to the Management Board reports whose frequency shall be fixed in the authorisation and may not exceed the period of 12 months.
§ 4 the report referred to in § 3 shall indicate the progress of the project, containing at least: (I)-indication of the areas where the collections were held by means of geographical coordinates, as well as the respective owners;
II-quantitative and qualitative listing of species or morphotypes collected in each area;
III-proof of deposit of sub-amostras in faithful depository institution accredited by the Management Board;
IV-presentation of the signed material transfer terms;
V-indication of funding sources, their amounts and the responsibilities and rights of each party; and VI-preliminary results.
§ 5 the interested in obtaining special permission for establishment of ex situ collection should direct application to the Management Board, proving the requirements listed in this article and in provisional measure no. 2,186-16, 2001.
§ 6 the institution that you want to perform other hits from the collection formed on the basis of the special permit referred to in this article must request specific authorization for both the Management Council or accredited institution in the form of art. 14 of provisional measure no. 2,186-16, 2001. " (NR)
"Art. 9-B. Special authorisations referred to in art. 11, subparagraph IV, points (a) to "c" and "d", of the provisional measure no. 2,186-16, 2001, shall not apply to activities of access to genetic heritage with the potential of economic use, such as bioprospecting or technological development, except for the provisions of art. 9-this Decree. " (NR)
"Art. 9-C. The authorisations referred to in arts. 8, 9 and 9-this Decree may include access and shipment, individually or together, in accordance with the request formulated by the institution concerned and to the terms of the authorisation granted by the Council of management or accredited institution in the form of art. 14 of provisional measure no. 2,186-16, 2001. " (NR)
Art. 3 this Decree shall enter into force on the date of its publication.
Art. 4 Is repealed. 12 of Decree No. 3945, of 28 September 2001.
Brasília, December 31 2003; 182 of independence and 115 of the Republic.

LUIZ INACIO LULA DA SILVA Marina Silva

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