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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. 4,946, OF December 31, 2003.

Altera, repeals and adds devices to the Decree no 3,945, of September 28, 2001, which regulates the Provisional Measure no 2.186-16, of August 23, 2001.

THE PRESIDENT OF THE REPUBLIC, in the use of the assignment that gives it the art. 84, inciso IV, of the Constitution,

DECRETA:

Art. 1º The Decree No. 3,945, of September 28, 2001, passes the vigour with the following amendments:

" Art. 8º You can get the authorizations that you treat the art. 11, inciso IV, points ("a" and "b", of the Provisional Measure No. 2.186-16, of 2001, the institution that meets the following requirements, among others that may be required by the Management Board:

I-proving that the institution:

a) constituted itself under Brazilian laws;

b) exerts research and development activities in the biological and related areas;

II-technical qualification for the performance of access activities and component sample shipment of the genetic heritage component or access to the associated traditional knowledge, when it is the case;

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V- presentation of the prior annuces of which it treats art. 16, § § 8º and 9º, of the Provisional Measure No. 2.186-16, of 2001;

VI-submission of prior annuence of the Indigenous or local community involved, when it comes to access to associated traditional knowledge, in observance of the arts. 8º, § 1º, art. 9º, inciso II, and art. 11, inciso IV, paragraph 2.186-16 (b) of the Provisional Measure No. 2.186-16, 2001;

VII-indication of the fate of the components of components of the genetic heritage or of the information concerning the associated traditional knowledge;

VIII-indication of the faithful institution trustee accredited by the Management Board where the component sub-samples of the genetic heritage are to be deposited;

IX-when it comes to access with purpose of scientific research, compromise term presentation signed by the legal representative of the institution, committing to access genetic heritage or traditional knowledge associated only for the authorized purpose; and

X-presentation of Agreement of Use of Genetic Heritage and Repartition of Benefits duly signed by the parties, when it comes to access to genetic heritage or to the associated traditional knowledge with potential of economic use, as occurs in the activities of bioprospecting and technological development.

§ 1º When access has the purpose of scientific research, the substantiation of the constant requirements of the incisos II and III of the caput of this article may be waived by the Board of Management or by the accredited institution in the form of the art. 14 of the Provisional Measure No. 2.186-16, of 2001.

§ 2º The research project referred to in the inciso IV of the caput of this article should contain:

I-introduction, justification, objectives, methods and results expected from the sample or the information to be accessed;

II-geographical location and timetable of the project steps, specifying the period in which the field activities will be developed and, when it comes to access to associated traditional knowledge, identification of Indigenous or local communities involved;

III-discrimination of the type of material or information to be accessed and approximate quantification of samples to be obtained;

IV-indication of the sources of funding, the respective amounts and the responsibilities and rights of each party;

V-identification of the team and curriculum vitae of the researchers involved, if they are not available in the Lattes Platform, held by the CNPq.

§ 3º The institution benefited by the authorization of which it treats this article should refer to the Management Board or the accredited institution in the form of the art. 14 of the Provisional Measure No. 2.186-16, of 2001, reports on the progress of the project, on deadlines to be fixed on the access permit. " (NR)

" Art. 9º You can obtain the special authorizations of which it treats art. 11, inciso IV, points "c" and "d", of the Interim measure No. 2.186-16, of 2001, for scientific research without potential economic use, the institution interested in realizing access to component of genetic heritage or traditional knowledge associate who meets the following requirements, among others that may be required by the Management Board:

I-voucher that the institution:

a) constituted under Brazilian laws;

b) exercises research and development activities in the biological and related areas;

II-technical qualification for the performance of the component sample access and remittance activities of the genetic heritage or of access to the associated traditional knowledge, when it is the case;

III-structure available for the handling of samples of components of the genetic heritage;

IV-portfolio of the projects and activities of routine that involve access and remittance to components of the genetic heritage developed by the institution;

V-presentation of the prior annuces of which treats art. 16, § § 8º and 9º, of the Provisional Measure No. 2.186-16, of 2001, when it comes to access to the component of genetic heritage;

VI-submission of prior annuence of the indigenous or local community involved, in observance of the arts. 8º, § 1º, art. 9º, inciso II, and art. 11, inciso IV, paragraph 2.186-16 (b) of the Provisional Measure No. 2.186-16, of 2001, when it comes to access to associated traditional knowledge;

VII-indication of the fate of the genetic material or the information relating to the knowledge traditional associate and the technical staff and the infrastructure available to manage the terms of transfer of material to be signed in advance to the sample shipment to another national, public or private institution, or based in the exterior;

VIII-term of commitment signed by the legal representative of the institution, committing to access genetic heritage or traditional knowledge associated only for the purposes of scientific research without potential of economic use.

§ 1º The portfolio referred to in the inciso IV of the caput of this article should bring the summary description of the activities to be developed, as well as the summarized projects, with the following requirements minimum:

I-goals, material, methods, intended use and target of the sample or information to be accessed;

II-area of comprehension of the field activities and, when it comes to access to knowledge traditional associate, identification of the indigenous or local communities involved;

III-indication of the sources of funding;

IV-team identification and curriculum vitae of the researchers involved, if they are not available on the Lattes Platform, maintained by the CNPq.

§ 2º The institution benefited by the authorisation of which it treats this article should refer to the Management Board or the accredited institution in the form of the art. 14 of the Provisional Measure No. 2.186-16, of 2001, reports whose periodicity shall be fixed in the authorisation, and may not exceed the period of twelve months.

§ 3º The report referred to in § 2nd shall contain, at a minimum:

I-detailed information about the progress of the projects and integral activities of the portfolio;

II-indication of the areas where the collections were carried out, by means of geographical coordinates;

III-Quantitative and qualitative listing of the species or morphotypes collected in each area;

IV-copy of the records of the information regarding the associated traditional knowledge;

V- proof of the deposit of the sub-samples in faithful institution trustee accredited by the Management Board;

VI-presentation of the Material Transfer Terms;

VII-indication of the sources of funding, the respective amounts and the responsibilities and rights of each party; and

VIII-preliminary results.

§ 4º The institution benefited by the authorization of which it treats this article may, during the duration of the authorization, enter new activities or projects in the portfolio, provided that you observe the conditions set forth in this article and, within sixty days from the beginning of the new activity or project, communicate the change held to the Board of Management or the accredited institution in the form of the art. 14 of the Provisional Measure No. 2.186-16, of 2001. " (NR)

Art. 2º The Decree No. 3,945, of 2001, passes on the invigoration increased of the following articles:

" Art. 9-A. You will be able to obtain the special permission from which you treat art. 11, inciso IV, paragraph 2.186-16 (c) of the Interim Measurements No. 2.186-16, of 2001, to realize access to genetic heritage for the purpose of constituting and integrating ex situ collections that target activities with economic use potential, such as bioprospecting or technological development, the institution that meets the following requirements, among others that may be required by the Board of Management:

I-voucher that the institution:

a) constituted under Brazilian laws;

b) exerts research and development activities in the biological and related areas;

II-technical qualification for performance of the formation and maintenance activities of ex collections situ or shipment of samples of components of the genetic heritage, when it is the case;

III-structure available for the handling of samples of components of the genetic heritage;

IV-project of constitution of ex situ collection from activities of access to genetic heritage;

V-presentation of the prior annuences of which treats art. 16, § § 8º and 9º, of the Provisional Measure No. 2.186-16, of 2001;

VI-indication of the fate of the genetic material, as well as of the technical staff and the available infrastructure to manage the terms of transfer of material to be signed in advance of the sample shipment to another national, public or private institution;

VII-signature, by the legal representative of the institution, of term of commitment by which it undertakes to access heritage genetic only for the purpose of constituting ex situ collection; and

VIII-presentation of Contract model of Genetic Heritage Utilization and Repartition of Benefits, to be firmed with the owner of the public area or private or with representative of the Indigenous community and the official indigenist organ.

§ 1º The model of Genetic Heritage Utilization Contract of which treats the inciso VIII of the caput of this article should be submitted to the Board of Management for approval, which will be conditional on the fulfillment of the provisions of the art. 28 of the Provisional Measure No. 2.186-16, of 2001, without prejudice to other requirements that may be required by the Council.

§ 2º The project that deals with the inciso IV of the caput of this article should bring the summary description of the activities to be developed, with the following minimum requirements:

I-objectives, material, methods, intended use, and target of the sample to be accessed;

II-area of comprehension of the activities of field;

III-indication of the sources of funding; and

IV-identification of the team and curriculum vitae of the researchers involved, if they are not available on the Lattes Platform, maintained by the CNPq.

§ 3º The institution benefited by the special authorization of which it treats this article should refer to the Management Board reports whose periodicity will be fixed in the authorisation, and may not exceed the twelve month period.

§ 4º The report referred to in § 3rd should indicate the progress of the project, containing at the very least:

I-indication of the areas where the collections were carried out by means of geographical coordinates as well as of the respective owners;

II-quantitative and qualitative listing of the species or morphotypes collected in each area;

III-substantiation of the deposit of the sub-samples in faithful depositary institution accredited by the Board of Management;

IV-submission of the terms of transfer of signed material;

V-indication of the sources of funding, the respective amounts and responsibilities and rights of each party; and

VI-preliminary results.

§ 5º The person interested in obtaining the special permission for ex situ collection constitution should direct application to the Board of Management, proving the fulfillment of the requirements mentioned in this article and in the Provisional Measure No. 2.186-16, from 2001.

§ 6º The institution that intends to carry out other accesses from the collection formed on the basis of the special authorization that it is this article should seek specific permission for both the Management Board or the accredited institution in the form of the art. 14 of the Provisional Measure No. 2.186-16, of 2001. " (NR)

" Art. 9-B. The special authorizations of which it treats art. 11, inciso IV, points (c) and "d", of the Provisional Measure No. 2.186-16, of 2001, do not apply to the activities of access to genetic heritage with economic use potential, such as bioprospecting or technological development, reshable the provisions of the art. 9-A of this Decree. " (NR)

" Art. 9-C. The authorisations to which the arts are referred. 8º, 9º and 9-A of this Decree will be able to cover access and remittance, either isolated or jointly, in accordance with the application formulated by the interested institution and with the terms of the authorisation granted by the Management Board or the accredited institution in the form of the art. 14 of the Provisional Measure No. 2.186-16, of 2001. " (NR)

Art. 3º This Decree comes into effect on the date of its publication.

Art. 4º It is revoked the art. 12 of Decree No. 3,945, of September 28, 2001.

Brasilia, December 31, 2003; 182º of Independence and 115º of the Republic.

LUIZ INÁCIO LULA DA SILVA

Marina Silva