PROVISIONAL MEASURE NO. 2.126-9, OF February 23, 2001

Regulates the inciso II of § 1º and § 4º of the art. 225 of the Constitution, the arts. 1º, 8º, paragraph "j", 10, paragraph "c", 15 and 16, points 3 and 4 of the Convention on Biological Diversity, provides on access to genetic heritage, protection and access to associated traditional knowledge, distribution of benefits and access to technology and the transfer of technology to its conservation and utilization, and gives other arrangements.

THE PRESIDENT OF THE REPUBLIC, in the use of the assignment that confers it on art. 62 of the Constitution, adopts the following Provisional Measure, with force of law:

CHAPTER I

OF THE GENERAL PROVISIONS

Art. 1º This Interim measure provides about the goods, the rights and obligations regarding access to the component of the existing genetic heritage in the national territory, on the continental shelf and in the exclusive economic zone, to the traditional knowledge to it associated and relevant to the conservation of the biological diversity, the integrity of the country's genetic heritage, the use of its components and the fair and eecitable allocation of the benefits derived from its exploration and on access to technology and technology transfer to the conservation and use of biological diversity.

§ 1º Access to the component of genetic heritage for the purposes of scientific research and technological development, bioprospecting or conservation, targeting its industrial or other nature application, will be far in the form of this Interim Measure, without prejudice to the material or immaterial property rights that focus on the component of the genetic heritage accessed or on the site of its occurrence.

§ 2º To the owners and holders of goods and rights of which it treats this article will be guaranteed, in the form of this Interim Measment, the fair and eective apportionment of the benefits derived from access to genetic heritage and to the associated traditional knowledge.

§ 3º Access to the component of the existing genetic heritage on the continental shelf will observe the provisions of Law No. 8,617 of January 4, 1993.

Art. 2º The exploration of the existing genetic heritage in the Country will only be done upon authorization or permission from the Union and will have its use, commercialization or exploitation for any purposes submitted to the supervision, in the terms and conditions set out in this Provisional Measure.

Single paragraph. It is owned by the Union the existing genetic heritage in its assets, as well as in the natural resources found on the continental shelf and the exclusive economic zone.

Art. 3º This Interim Measure does not apply to the whole or part of human beings, including their genetic components.

Art. 4º It is preserved the exchange and diffusion 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. 5º It is vetoed the access to genetic heritage for harmful practices to the environment and human health and to the development of biological and chemical weapons.

Art. 6º At any time, existing solid scientific evidence of danger of serious and irreversible harm to biological diversity, arising from activities practiced in the form of this Provisional Measure, the Public Power, by intermediate of the organ provided for in the art. 11, on the basis of technical advice and with criteria of proportionality, shall adopt measures designed to prevent the damage, and may, including, sustain the activity, in the form of the regulation, respected the competence of the organ responsible for the biosafeeness of genetically modified organisms.

CHAPTER II

DAS DEFINITIONS

Art. 7º In addition to the concepts and the definitions set out in the Convention on Biological Diversity, it considers itself for the purposes of this Provisional Measure:

I-genetic heritage: information of genetic origin, contained in whole or in part of plant, fungal, microbial or animal specimens, in substances from the metabolism of these living beings and from excerpts obtained from these living or dead organisms, found in conditions in situ, inclusive domesticated, or kept in ex situ collections, provided that they collected under in situ conditions, in the national territory, on the continental shelf or in the area exclusive economic;

II-associated traditional knowledge: information or individual or collective practice of Indigenous community or local community, with real or potential value, associated with genetic heritage;

III-local community: human group, including remnants of quilombos communities, distinct by their cultural conditions, which traditionally organizes, for successive generations and customs of their own, and which retains its social and economic institutions;

IV-access to genetic heritage: obtaining sample of component of genetic heritage for scientific, research, technological development, bioprospecting, or conservation purposes, aiming at their industrial or other nature application;

V-access to the associated traditional knowledge: obtaining information about individual or collective knowledge or practice associated with genetic heritage, from indigenous community or local community, for scientific, research and technological development purposes, aiming for their industrial or other nature application;

VI-access to technology and technology transfer: realization of actions that are aimed at the access, development and transfer of technologies for the conservation and use of biological diversity or that use genetic heritage or associated traditional knowledge;

VII-bioprospecting: exploratory activity that aims to identify components of the genetic heritage and information on the associated traditional knowledge, with potential for commercial use;

VIII-threatened species of extinction: species with high risk of disappearance in nature in the near future, thus recognized by the competent authority;

IX-domesticated species: species in whose evolution process has influenced human to meet your needs, being here included species, varieties and breeds in different stages of domestication;

X-Access Authorization: instrument expedised by the organ that treats art. 11 of this Provisional Measure that allows, under specific conditions, access to component sample of the genetic heritage and to the associated traditional knowledge;

XI-Material Transfer Term: instrument of accession to be firmed up by the recipient institution prior to the shipment of any component sample of the genetic heritage, with or without commercial end;

XII-Contract of Use of Genetic Heritage and of the Repartition of Benefits: multilateral legal instrument, which qualifies the parties, the object and the conditions of access and shipment of component of the genetic heritage and associated traditional knowledge, as well as the conditions of apportionment of benefits.

CHAPTER III

OF THE ASSOCIATED TRADITIONAL KNOWLEDGE PROTECTION

Art. 8º The traditional knowledge of the indigenous communities and local communities associated with the genetic heritage will be protected by this Provisional Measure against the illicit use and exploitation and other aggrieved or unauthorized actions by the organ that it treats art. 11.

§ 1º The state recognizes the right that Indigenous communities and local communities have to decide on the use of their traditional knowledge associated with the country's genetic heritage, pursuant to this Measure Provisional and its regulation.

§ 2º The traditional knowledge associated with the genetic heritage of which it treats this Provisional Measure integrates the Brazilian cultural heritage.

§ 3º The traditional knowledge associated with genetic heritage will be able to be the object of enrollment, as the regulation disposes.

§ 4º The protection heard by this Provisional Measure cannot be interpreted so as to prevent the preservation, use and development of the traditional knowledge of indigenous communities or local communities.

§ 5º The protection ora instituted will not affect, harm or limit any other form of rights concerning intellectual property.

Art. 9º To Indigenous communities and local communities who create, develop, detain, retain or preserve traditional knowledge associated with genetic heritage, the right to:

I-have indicated the origin of access to traditional knowledge in all publications, uses, holdings and disclosures;

II-prevent unauthorized third parties from using, conducting tests, surveys or exploration, related to the associated traditional knowledge;

III-preventing unauthorized third parties from releasing, transmitting or relaying data or information that integrate or constitute traditional knowledge associated;

IV-perceive benefits, remuneration, or royalties for economic exploitation by third parties, directly or indirectly, of associated traditional knowledge, whose rights are of their entitlement.

Single paragraph. For the purposes of this Provisional Measure, any traditional knowledge associated with genetic heritage may be of entitlement to the community, yet only an individual, member of that community, detains that knowledge.

Art. 10. To the person of good faith who, until June 30, 2000, used or otherwise economically exploit any traditional knowledge in the Country, the right to continue the use or exploitation, without burden, in the form and in the previous conditions, shall be ensured.

Single paragraph. The right conferred in the form of this article may only be ceded together with the business or company, or part of this which has direct relation to the use or exploitation of knowledge, by disposal or leasing.

CHAPTER IV

OF THE INSTITUTIONAL ATTRIBUTIONS

Art. 11. The Executive Power shall establish an Interministerial Council, bound by the Civil House of the Presidency of the Republic, composed of representatives of the bodies holding legal competence over the various actions of which it treats this Provisional Measure, with the following purposes:

I-grant authorization of access to component sample of the existing genetic heritage in in situ conditions, in the national territory, on the continental shelf and in the exclusive economic zone;

II-grant authorization of access to the associated traditional knowledge, upon prior annuence of their holders;

III-scrutinize, in articulation with federal bodies, the access activities the sample of component of genetic heritage and associated traditional knowledge, in the form of the art. 29;

IV-grant authorization for component shipment of component of the genetic heritage and associated traditional knowledge for national, public or private institution, or for institution based abroad;

V-scrutinize, in articulation with federal bodies, any component shipment of component of the genetic heritage and associated traditional knowledge, in the form of the art. 29;

VI-follow up and evaluate access to technology and technology transfer for the conservation and use of genetic heritage and associated traditional knowledge;

VII-release lists of exchange species facilitated constants of international agreements, including on food security, of which the Country is a signatory, according to the single paragraph of the art. 16 of this Interim Measurage;

VIII-create and maintain database for record of information obtained from the field during the component sample collection of the genetic heritage;

IX-create and maintain base of data for information record on the associated traditional knowledge;

X-create, maintain, and disseminate database for information record on all access authorizations and component sample shipment of the genetic heritage and associated traditional knowledge;

XI-grant to the national public or private institution, which exerts research and development activity in the biological and related areas, and the national university, public or private, special access permit, with a duration of up to two years, renewable for equal periods;

XII-accrediting national public institution of research and development, delegating to it, upon convenium, competence to authorize sample shipment of component of the genetic heritage to national, public or private institution, or to institution based abroad, respected the requirements of the art. 16 of this Provisional Measure;

XIII-delegating, in the hypothesis provided for in the previous incistion, to the national public institution for research and development that it treats the same inciso, competence for, when it is the case, firming, in the name of the organ of which it treats the caput of this article, the Genetic Heritage Utilization Contract and the Benefits partition;

XIV-accrediting national public and private institution to, upon convenium, be faithful trustee of representative sample of component of the genetic heritage to be remitted to national, public or private institution, or based abroad.

Art. 12. The Interministerial Council of which it treats the previous article, will have its structure and functioning laid out in a specific decree of the Executive Power.

CHAPTER V

OF THE ACCESS AND THE SHIPMENT

Art. 13. The access to the component of the existing genetic heritage in situ conditions, in the national territory, on the continental shelf and in the exclusive economic zone and the associated traditional knowledge will be done by collecting the sample and information, respectively, and will only be authorized to the national, public or private institution, which carries out research and development activities in the biological and related areas, pursuant to the regulation.

§ 1º Access to genetic heritage samples and associated traditional knowledge will only be able to occur after obtaining the Access Authorization next to the body envisioned in the art. 11.

§ 2º Access Authorization is conditional on the pick-up of emoluments and the fulfillment of the other legal and regulatory requirements.

§ 3º Access to genetic heritage samples, under in situ conditions, and the associated traditional knowledge will only be able to occur after signing of Genetic Heritage Utilization Contract and Benefits Breakdown.

§ 4º The participation of legal person based abroad, in the component sample collection of the genetic heritage in situ and in the access to the associated traditional knowledge, will only be authorized when made in set with national public institution, being the coordination of the activities mandatorily carried out by the latter and provided that all the involved institutions exercise research and development activities in the biological and related areas.

§ 5º Research on components of genetic heritage is to be carried out preferentially on the national territory.

§ 6º The Access Authorization of component sample of the genetic heritage of endemic or endangered species will depend on the prior annuence of the competent organ.

§ 7º The authorization for the ingress on indigenous lands, for access to the component sample of genetic heritage and associated traditional knowledge, will depend on the prior annuence of the indigenous community involved, listened to the official indigenist organ.

§ 8º The authorization for the ingress in protected areas, for access to the component sample of the genetic heritage and to the associated traditional knowledge, will depend on the prior annuence of the competent body.

§ 9º The authorization for admission to the public or private area, for access to the component sample of the genetic heritage, or of associated traditional knowledge, will depend on the prior annuence of the holder, or the community site involved, holding the holder of the permit to be liable to ressarate it for possible damage or damage caused, as long as it is properly proven.

§ 10. The permit for admission to the areas indispensable to national security, for access to the component sample of genetic heritage and associated traditional knowledge, will be subject to the prior hearing of the National Defense Council.

§ 11. The authorization for admission to Brazilian jurisdictional waters for the purposes of collecting samples of components of the genetic heritage, whether associated or not to traditional knowledge, will depend on prior annuence of the maritime authority.

Art. 14. In cases of relevant public interest, thus characterized by the competent authority, the ingress into indigenous land, public or private area for access to genetic resources will waived prior annuence of Indigenous and local communities and of owners, guaranteeing them the provisions of the art. 21 of this Provisional Measure.

Single paragraph. In the case provided in the caput of this article, Indigenous and local communities and owners should be informed beforehand.

Art. 15. The ex situ collections of samples of the genetic heritage should be enrolled together with the organ that treats art. 11, within the maximum of one year, as of June 30, 2000, as the regulation is available.

Single paragraph. The ex situ conservation of samples of components of the genetic heritage is to be carried out preferentially on the national territory.

Art. 16. The shipment of any component sample of the genetic heritage to public or private recipient institution, nationally or based abroad, will be effective from material under ex situ conditions, upon information of the intended use and the prior signing of the Material Transfer Term, observed the cumulative fulfillment of the following conditions, in addition to others that the regulation establish:

I-representative sample deposit in depositary bank headquartered in accredited institution, according to the inciso XIV of the art. 11 of this Provisional Measure;

II-provision of information obtained from the field, during the collection of samples of components of the genetic heritage, for record in database mentioned in the inciso VIII of the art. 11 of this Provisional Measure;

III-provision of information on the associated traditional knowledge accessed, when it occurs, for registration in the database mentioned in the inciso IX of the art. 11 of this Provisional Measure, resguarded the secretive aspects;

IV-provision of information, when it is the case, about access to technology and technology transfer from which they treat the arts. 18, 19 and 20 of this Provisional Measure, without prejudice to the intellectual property legislation in force and of the sigilous aspects provided for in the contract of which it treats the caput.

§ 1º Whenever there is prospect of commercial use of product or process resulting from component of the genetic heritage, the prior signing of the Genetic Heritage Utilization Contract and Repartition Agreement will be required of Benefits.

§ 2º The sample shipment of component of the genetic heritage of species deemed to be facilitated exchange in international agreements, including on food security, of which the Country is a signatory, should be effected in accordance with the conditions set out in these agreements, kept the constant requirements of the incisies of this article.

Art. 17. The shipment of any component sample of the genetic heritage, with or without commercial purpose, should be preceded by the signature of Material Transfer Term, firmed by the recipient institution and returned to the supplier institution.

Single paragraph. The Material Transfer Term will have its model approved by the regulation of this Provisional Measure.

CHAPTER VI

FROM ACCESS TO TECHNOLOGY AND TECHNOLOGY TRANSFER

Art. 18. The institution that receives component sample of the genetic heritage or associated traditional knowledge will facilitate access to technology, and transfer of technology for the conservation and use of this Heritage or that Knowledge to the national institution responsible for access and for the sample transfer of component of genetic heritage and associated traditional knowledge, or institution by it indicated.

Art. 19. Access to technology and technology transfer between research and development institutions, public and private, national and based abroad will be able to take place, among other activities, upon:

I- scientific research and technological development;

II-formation and empowerment of human resources;

III-exchange of information;

IV-exchange between institutions research nationals and research institutions with headquarters abroad;

V-consolidation of scientific research and technological development infrastructure;

VI-economic exploration, in partnership, of processes and products derived from the use of component of the genetic heritage; and

VII-establishment of joint technological base ventures.

Art. 20. The companies that, in the process of ensuring access to technology and technology transfer to national, public or private institutions, responsible for the access and sample transfer of the genetic heritage component and the associate traditional knowledge, invest in research and development activities in the Country will jus the tax incentives for the technological empowerment of industry and agri-farming, and other stimulus instruments, in the form of the legislation pertinent.

CHAPTER VII

OF THE BENEFITS APPORTIONMENT

Art. 21. The benefits resulting from the economic exploitation of product or process developed from sample of component of the genetic heritage, obtained by national institution or institution based abroad, will be fairly and fairly rebroken equesment between the Union and the contracting parties, as the regulation disposes.

§ 1º When the benefits of which treats the caput of this article will arise from the economic exploitation of the genetic heritage accessed on indigenous lands or in local community area, the respective community will make jus the percent of its apportionment.

§ 2º In the event that the sample of the genetic heritage component has been accessed in area owned by State, Municipality or in particular, it is guaranteed to the holder of the percentage area of the benefits mentioned in the caput of this article, in the title of incentive for conservation of genetic heritage, in the form of the regulation.

Art. 22. Indigenous communities or local communities will jus the percentage of benefit stemming from the use of information from the associated traditional knowledge, obtained in these communities.

Art. 23. The benefits arising from the economic exploitation of the genetic heritage accessed by the national institution or institution based abroad, to be rebroken among the contracting parties, in a fair and eequitative manner, will be able to constitute, among other, from:

I-division of profits and royalties resulting from the economic exploitation of processes and products developed from component sample of the genetic heritage;

II-access and transfer of technologies;

III-licensing, free of burden, of products and processes; and

IV-capacity-building of human resources.

Art. 24. The economic exploitation of product or process developed from sample of component of the genetic heritage, accessed at odds with the provisions of this Interim Measurer, will subject the offender to the payment of severance corresponding to, at minimum, twenty percent of the gross billing obtained in the marketing of product or royalties obtained from third parties by the offender, in the process licensing hypothesis or the use of the technology, protected or not by intellectual property, without prejudice to the administrative penalties in the form of this Provisional Measure and criminal penalties provided for in the current legislation.

Art. 25. The contract for the Use of Genetic Heritage and the Repartition of Benefits, a multilateral legal instrument, should indicate and qualify with clarity the contracting parties, namely:

I-on one side:

a) the Federal Union;

b) the owner of the area, public or private, or the representative of the Indigenous community and the official indigenistic organ, or the representative of the local community;

II-de other side:

a) the national institution authorized to access; and

b) the addressable institution.

Art. 26. They are essential clauses of the Genetic Heritage Utilization Contract and the Repartition of Benefits, the ones they have about:

I-object, its elements, quantification of the sample and intended use;

II-duration of duration;

III-form of fair and eequitative allocation of benefits;

IV-rights and responsibilities of the parties;

V-right of ownership intellectual;

VI-conditions of access to technology and technology transfer;

VII-termination;

VIII-penalties;

IX-venue.

CHAPTER VIII

OF THE ADMINISTRATIVE SANCTIONS

Art. 27. Administrative infringement is considered against the genetic patrimony or the traditional knowledge associated with all action or omission that violates the rules provided for in this Provisional Measure.

§ 1º Administrative infractions will be punished in the form set out in the regulation of this Provisional Measure, with the following sanctions:

I-warning;

II-fine;

III-seizure of the products and components of the genetic heritage;

IV-suspension of sale of the product;

V-embargo of the activity;

VI-partial or total interdiction of the establishment, activity, or undertaking;

VII-suspension of legally required registration, license or authorization;

VIII-cancellation of legally required registration, license or authorization;

IX-loss or restriction of incentives and tax benefits granted by the government;

X-loss or suspension of participation in lines of financing in official credit establishments;

XI-intervention in the establishment;

XII-prohibition of hiring with the Public Administration, for period of up to five years.

§ 2º The material or the product and the instruments of which it treats the preceding paragraph shall have its intended target set by the competent organ, including its destruction.

§ 3º The sanctions set out in this article will be applied by the body of which it treats art. 11, in the procedural form set out in the Regulation of this Interim Measlant, without prejudice to the civil or criminal penalties that are fit.

§ 4º The fines of which deals with the inciso II of § 1º of this article shall be arbitrated by the competent authority in accordance with the seriousness of the infringement and in the form of the regulation, and may vary from R$ 200.00 (two hundred reais) to R$ 100,000.00 (one hundred thousand reais), when it comes to physical person.

§ 5º If the infraction is committed by legal person, or with its contest, the fine will be R$ 10,000.00 (ten thousand reais) to R$ 50,000,000.00 (fifty million reais), arbitrated by the competent authority, according to the gravity of the infraction, in the form of the regulation.

CHAPTER IX

Of The Finals

Art. 28. The granting of industrial property law by the competent bodies, on process or product obtained from sample of component of the genetic heritage, shall be conditional on the observance of this Interim Measment, and the applicant shall inform the origin of the genetic material and associated traditional knowledge, when it is the case.

Art. 29. The surveillance, interception and seizure of component of component of the genetic heritage accessed at odds with the provisions of this Interim Measure will be exercised by federal bodies in accordance with what the regulation disposes, and may, yet, such activities are decentralized, upon convennials.

Art. 30. By the provision of the services provided for in this Provisional Measure shall be charged for consideration, the value of which and the process of the pick-up shall be established in act of the holder of the organ of the Federal Public Administration to which such services are linked.

Single paragraph. The proceeds from the retribution that it treats this article will constitute own revenue from the organ that it treats art. 11, the application of which shall be by it defined in resolution.

Art. 31. The share of profits and royalties, due to the Union, resulting from the economic exploitation of processes or products developed from sample of component of the genetic heritage, as well as the fines and indemniations of which it treats this Measure Provisional shall be earmarked for the National Environment Fund, set up by Law No. 7,797 of July 10, 1989, to the Naval Fund, created by Decree No. 20,923 of January 8, 1932 and to the National Fund for Scientific and Technological Development, created by the Decree-Law No. 719 of July 31, 1969 and reinstated by Law No. 8,172 of January 18, 1991 in the form of the regulation.

Single paragraph. The resources of which it treats this article will be used in the conservation of biological diversity, in promoting the sustainable use of its components, in the fostering of scientific research, in the technological development associated with genetic heritage and in the empowerment of human resources.

Art. 32. The Executive Power shall regulate this Provisional Measure by December 30, 2000.

Art. 33. The provisions of this Provisional Measure do not apply to the matter governed by Law No. 8,974 of January 5, 1995.

Art. 34. They are convalidated the acts practiced on the basis of the Provisional Measure No. 2.126-8 of January 26, 2001.

Art. 35. This Interim Measure shall come into force on the date of its publication.

Brasilia, February 23, 2001; 180º of Independence and 113º of the Republic.

FERNANDO HENRIQUE CARDOSO

Pedro Parente