Provisional Measure No. 2052-3 Of September 27, 2000

Original Language Title: Medida Provisória nº 2.052-3, de 27 de Setembro de 2000

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.
PROVISIONAL MEASURE No. 2052-3, SEPTEMBER 27TH 2000
Regulates item II of § 1 and § 4 of art. 225 of the Constitution, Art. 1, 8, paragraph? J ?, 10 point? C ?, 15 and 16, paragraphs 3 and 4 of the Convention on Biological Diversity, provides for access to genetic resources, protection and access to associated traditional knowledge, sharing benefits and access to technology and transfer of technology for its conservation and use, and other measures.
The PRESIDENT OF THE REPUBLIC, using the powers conferred upon him by art. 62 of the Constitution, adopts the following Provisional Measure, with force of law: CHAPTER I


GENERAL PROVISIONS Art. 1. This Provisional Measure provides for the assets, rights and obligations relating to access to components of the genetic heritage on the national territory, on the continental shelf and the exclusive economic zone, the traditional knowledge associated with it and relevant to the conservation of biological diversity, the integrity of the genetic patrimony of the country, the use of its components and the fair and equitable sharing of benefits derived from their exploitation and access to technology and technology transfer for the conservation and use of biological diversity.
§ 1 Access to components of the genetic heritage for scientific research and technological development purposes, bioprospecting or conservation to its industrial or other application shall be made in the form of this Provisional Measure, without prejudice to the rights of property material or immaterial that concern the component of genetic resources accessed or the place of its occurrence.
§ 2. To the owners and holders of goods and rights referred to in this Article shall be guaranteed in accordance with this Provisional Measure, the fair and equitable sharing of benefits derived from access to genetic resources and associated traditional knowledge.
§ 3. The access to the genetic heritage component on the continental shelf observe the provisions of Law No. 8,617, of January 4, 1993.
Art. 2 The exploration of the genetic heritage in the country will only be made with authorization or permission of the Union and have their use, marketing or use for any purpose subject to inspection under the terms and conditions established in this Provisional Measure.
Sole paragraph. It is owned by Union the genetic heritage existing in their property, and natural resources found on the continental shelf and the exclusive economic zone.
Art. 3. This Provisional Measure does not apply to all or part of human beings, including its genetic components.
Art. 4 is preserved the exchange and dissemination of components of the genetic heritage and associated traditional knowledge practiced among indigenous and local communities among themselves, for their own benefit and based on customary practice.
Art. 5 It is forbidden the access to genetic resources for practices harmful to the environment and human health and to the development of biological and chemical weapons.
Art. 6 At any time, there solid scientific evidence of threats of serious and irreversible damage to biological diversity resulting from activities carried out in the form of this Provisional Measure, the Government, through the body provided for in art. 11, based on expert opinion and proportionality criteria, adopt measures to prevent the damage, and can even stop the activity, according to the regulations, respecting the powers of the body responsible for the biosafety of genetically modified organisms.

CHAPTER II DEFINITIONS
Art. 7 In addition to the concepts and definitions of the Convention on Biological Diversity, it is considered for purposes of this Provisional Measure:
I - genetic heritage: information of genetic origin contained in whole or in part of plant specimen, fungal, microbial or animal in metabolism substances derived from these living beings and extracts obtained from these living or dead organisms, found in situ, including domesticated, or kept in ex situ conditions, provided that collected in situ, in the national territory, continental shelf or the exclusive economic zone;
II - associated traditional knowledge: information or individual or collective practices of an indigenous or local community, with real or potential value, associated with the genetic heritage;

III - local community: human group, including remnants of Quilombo communities, distinguished by its cultural conditions, which is organized traditionally through successive generations and customs, and preserves its social and economic institutions;
IV - access to the genetic heritage: obtaining the genetic heritage component sample for scientific purposes, research, technological development, bioprospecting or conservation to the industrial application or otherwise.
V - access to traditional knowledge associated with: obtaining information about knowledge or individual or collective practices associated with genetic resources, indigenous or local community community for scientific, research and technological development for industrial application or otherwise;
VI - access to technology and technology transfer: performing actions that aim to access, development and transfer of technologies to conservation and use of biological diversity or make use of the genetic heritage or associated traditional knowledge;
VII - Bioprospecting: exploratory activity aimed at identifying components of the genetic heritage and information on associated traditional knowledge with potential for commercial use;
VIII - endangered species: species at high risk of disappearing in the wild in the near future, as recognized by the competent authority;
IX - domesticated species: species in which the evolutionary process has influenced human beings to meet their necessities, being here included species, varieties and breeds at different stages of domestication;
X - Access Authorization: instrument issued by the body mentioned in art. 11 of this Provisional Measure that allows, under specific conditions, access to the genetic heritage component sample and associated traditional knowledge;
XI - Transfer of Material: instrument of accession to be signed by the receiving institution prior to shipment of any samples of components of the genetic heritage, with or without commercial purpose;
XII - Contract for Use of Genetic Heritage and Benefit Sharing: multilateral legal instrument that qualifies the parties, the object and the conditions of access and of genetic heritage components of shipping and associated traditional knowledge, and the conditions of benefit sharing.

CHAPTER III PROTECTION TO TRADITIONAL KNOWLEDGE ASSOCIATED
Art. 8. The traditional knowledge of indigenous and local communities associated with the genetic heritage will be protected by this Provisional Measure against the use and illicit exploitation and other prejudicial actions or not authorized by the body mentioned in art. 11.
§ 1. The State recognizes the right of indigenous communities and local communities have to decide on the use of their traditional knowledge associated with genetic patrimony of the country, in terms of this Provisional Measure and the regulations.
§ 2 The traditional knowledge associated with genetic heritage that this Provisional Measure is part of the Brazilian cultural heritage.
§ 3 The traditional knowledge associated with genetic resources may be joined object, according to the regulation.
§ 4 The protection afforded by this Provisional Measure may not be interpreted so as to impede the preservation, use and development of traditional knowledge of indigenous or local communities.
§ 5 The now established protection shall not affect, impair or limit any other form of rights to intellectual property.
Art. 9 At indigenous and local communities that create, develop, hold, retain or preserve traditional knowledge associated with genetic resources, the right is guaranteed:
I - have indicated the origin of the access to traditional knowledge in all publications, uses , explorations and disclosures;
II - prevent unauthorized third parties from using tests, research or exploration relating to associated traditional knowledge;
III - prevent unauthorized third parties to disclose, transmit or retransmit data or information that incorporate or constitute associated traditional knowledge;
IV - realize benefits, compensation or royalties for economic exploitation by third parties, directly or indirectly, associated traditional knowledge, whose rights are owned by them.

Sole paragraph. For the purposes of this Provisional Measure, any traditional knowledge associated with the genetic heritage may be of community ownership, if only an individual member of the community holds that knowledge.
Art. 10. A person who in good faith, to June 30, 2000, used or economically exploited any traditional knowledge in the country, shall be entitled to continue to use or exploitation, without charge, in the manner and under the above conditions.
Sole paragraph. The right conferred under this Article may only be assigned together with the business or company, or part thereof that has direct relation with the use or exploitation of knowledge, for sale or lease.

Chapter IV RESPONSIBILITIES OF INSTITUTIONAL
Art. 11. The Executive Branch will establish a Ministerial Council, linked to the Civil House of the Presidency, composed of representatives of agencies that hold legal expertise on the various actions that this Provisional Measure, for the following purposes:
I - grant authorization of access to samples of components of the genetic heritage existing in situ within the national territory, on the continental shelf and exclusive economic zone;
II - granting authorization of access to traditional knowledge associated with prior consent of the holders thereof;
III - monitor, in conjunction with federal agency, the activities of access to genetic heritage component sample and associated traditional knowledge in the art. 29;
IV - grant authorization for shipment of genetic heritage component sample and associated traditional knowledge to national, public or private institution, or institution with its headquarters abroad;
V - to supervise, in coordination with federal agencies, any shipment of genetic heritage component sample and associated traditional knowledge in the art. 29;
VI - monitor and evaluate the access to technology and technology transfer for the conservation and use of genetic resources and associated traditional knowledge;
VII - disclose lists of species designated for facilitated exchange constants of international agreements, including on food safety, of which the country is a signatory, according to the sole paragraph of art. 16 of this Provisional Measure;
VIII - create and maintain database for recording information obtained during the field collection of genetic heritage components of the sample;
IX - create and maintain database for recording information on associated traditional knowledge;
X - create, maintain and disseminate database for recording information about all authorizations for access and shipment of genetic heritage component sample and associated traditional knowledge;
XI - to grant to the public national institution or private, which carries on research and development activities in the biological and related fields, and national, public or private university, special access authorization, with a term of up to two years, renewable for the same period;
XII - credeciar national public institution development research, delegating him, by agreement, the power to authorize the component of sample shipment of genetic heritage for national, public or private institution, or institution located abroad, subject to the art requirements. 16 of this Provisional Measure;
XIII - delegate, as provided in the preceding item, the national public institution of research and development referred to in the same paragraph, the power, where appropriate, signing on behalf of the body referred to in the heading of this article the Usage Agreement Genetic Resources and Benefit-Sharing;
XIV - accredit public institution and national private to, by agreement, be faithful depository representative sample of genetic heritage components to be sent to national, public or private institution, or headquartered abroad.
Art. 12. The Interministerial Council mentioned in the previous article, will have its structure and operation arranged in specific decree of the Executive Branch.

Chapter V ACCESS AND DISPATCH

Art. 13. Access to components of the genetic heritage in situ within the national territory, on the continental shelf and the exclusive economic zone and the traditional knowledge far shall be associated by sample collection and information, respectively, and only It will be authorized at national, public or private institution, which carries on research and development activities in the biological and related fields, in accordance with the Regulation.
§ 1 Access to samples of genetic heritage and associated traditional knowledge may only occur after obtaining access authorization from the agency provided for in art. 11.
§ 2 The access authorization is subject to the payment of fees and compliance with other legal and regulatory requirements.
§ 3 The access to samples of genetic heritage, in situ, and associated traditional knowledge may only occur after use of contract signing the Genetic Heritage and Benefit-Sharing.
§ 4 The participation of legal entities based abroad, the component of sample collection of genetic heritage in situ and access to associated traditional knowledge, will only be permitted when done in conjunction with national public institution, and the coordination of activities obligatorily carried out by it and provided that all institutions involved carry research and development activities in the biological and related fields.
§ 5 Research on the genetic heritage components should preferably be done in the country.
§ 6 The Access Authorization to the genetic heritage component sample of endemic species or extinction threat will depend on the prior consent of the competent body.
§ 7 Authorisation for entry into indigenous lands, for access to the genetic heritage component sample and associated traditional knowledge, subject to prior consent of the indigenous community involved, according to the Official Funai.
§ 8 Authorisation for entry into protected areas for access to the genetic heritage component sample and associated traditional knowledge, subject to prior approval of the competent body.
§ 9 Authorization for entry into public or private area for access to the genetic heritage components of the sample, or associated traditional knowledge, subject to prior consent of the holder, or the local community involved, taking responsibility for the holder the authorization to reimburse them for any damage or loss, if properly proven.
§ 10. The authorization for entering the areas essential to national security, for access to the genetic heritage component sample and the associated traditional knowledge shall be subject to prior hearing of the National Defense Council.
§ 11. The authorization for entry into Brazilian waters for collection purposes samples of genetic heritage components, associated or not to traditional knowledge, depend on prior approval of the maritime authority.
Art. 14. In cases of significant public interest, as defined by the competent authority, the entry into indigenous lands, public or private area for access to genetic resources not require prior consent of indigenous and local communities and owners, assuring them the provisions of art. 21 of this Provisional Measure.
Sole paragraph. In the case referred to in this article, indigenous and local communities and owners should be informed in advance.
Art. 15. The ex situ collections samples of genetic heritage must be registered with the body referred to in art. 11, no later than one year from the date of June 30, 2000, according to the regulation.
Sole paragraph. The ex situ conservation of samples of genetic heritage components should preferably be done in the country.
Art. 16. The shipment of any samples of components of the genetic heritage for public receiving institution or private, domestic or based abroad, will be effective from material in ex situ, by the intended use information and prior signing of the Transfer Agreement material, subject to the cumulative fulfillment of the following conditions, among others that the regulation establish:
I - representative sample of deposit depositary bank based in accredited institution in accordance with section XIV of art. 11 of this Provisional Measure;

II - provision of information from the field, while collecting samples of components of the genetic heritage for registration in the database mentioned in item VIII of art. 11 of this Provisional Measure;
III - providing information on associated traditional knowledge accessed, when it occurs, for registration in the database mentioned in item IX of art. 11 of this Provisional Measure, safeguarding the confidential aspects;
IV - provision of information, where appropriate, on access to technology and transfer that technology in arts. 18, 19 and 20 of this Provisional Measure, without prejudice to intellectual property legislation and sensitive aspects mentioned in the contract of the caput.
§ 1 Whenever commercial use perspective resulting product or process of genetic heritage components, the prior signing of the Contract of Use of Genetic Heritage and Benefit-sharing will be required.
§ 2 The component sample shipment of genetic heritage of species considered for facilitated exchange in international agreements, including on food safety, of which the country is a signatory, must be made in accordance with the conditions laid down in those agreements, maintaining the contained in paragraphs requirements of this article.
Art. 17. The shipment of any samples of components of the genetic heritage, with or without commercial purpose should be preceded by the signing of Material Transfer Agreement, signed by the receiving institution and returned to the provider institution.
Sole paragraph. The Material Transfer Agreement will have their design approved by the Regulation of this Provisional Measure.

Chapter VI OF ACCESS TECHNOLOGY AND TECHNOLOGY TRANSFER
Art. 18. The institution receiving the genetic heritage component sample or associated traditional knowledge will facilitate access to technology and technology transfer for the conservation and use of that heritage or that knowledge to the national institution responsible for access and the component sample transfer genetic resources and associated traditional knowledge, or institution for it indicated.
Art. 19. Access to technology and technology transfer between research and development institutions, public and private, national and headquartered abroad may be carried out, among other activities, by:
I - scientific research and technological development;
II - training of human resources;
III - exchange of information;
IV - exchange between national research institutions and research institutions based abroad;
V - consolidation of scientific research infrastructure and technological development;
VI - economic exploitation, in partnership, processes and products derived from the genetic heritage components use; and
VII - establishment of joint technology-based ventures.
Art. 20. Companies in the process of ensuring access to technology and technology transfer to national institutions, public or private, responsible for access and the component sample transfer of genetic resources and associated traditional knowledge, invest in research activities and development in the country will be entitled to tax incentives for technological training of industry and agriculture, and other incentive instruments in the pertinent legislation.

Chapter VII THE BENEFIT SHARING
Art. 21. The benefits of the product of economic exploitation or process developed from the genetic heritage component sample obtained by a national institution or institution with its headquarters abroad shall be shared fairly and equitably between the Union and the contracting parties, as provided the Regulation.
§ 1 When the benefits of the caput of this article result from economic exploitation of genetic resources accessed on indigenous lands or local community area, their community will be entitled to a percentage of their allocation.
§ 2 In the case of the genetic heritage components of the sample have been accessed in state property area, municipality or private, is secured to the holder of the percentage area of ​​the benefits mentioned in this article, as an incentive for conservation of genetic resources, in the form of regulation.

Art. 22. Indigenous communities or local communities will be entitled to benefit percentage from the use of information associated traditional knowledge obtained in these communities.
Art. 23. The benefits arising from economic exploitation of genetic resources accessed by national institution or foreign-based institution, to be shared between the parties in a fair and equitable manner, may constitute, among others, to:
I - profit sharing and royalties arising from economic exploitation of processes and products developed from the genetic heritage component sample;
II - access and technology transfer;
III - licensing, free of charge, products and processes; and
IV - training of human resources.
Art. 24. The economic exploitation of a product or process developed from the genetic heritage component sample, accessed at odds with the provisions of this Provisional Measure, shall subject the violator to pay compensation equivalent to at least twenty percent of the gross revenues obtained in the marketing of the product or of royalties obtained from third parties for infringing on licensing hypothesis process or the use of technology, whether or not protected by intellectual property, without prejudice to the administrative penalties in the form of this Provisional Measure and criminal penalties provided by law.
Art. 25. The Contract for Use of Genetic Heritage and Benefit-Sharing, multilateral legal instrument shall indicate and describe clearly the contracting parties, namely:
I - on one side:
a) the Federal Government;
B) the owner of the area, public or private, or the representative of the indigenous community and the official indigenous body, or the representative of the local community;
II - on the other hand:
a) the authorized national institution to make access; and
b) the receiving institution.
Art. 26. It is essential terms of the Contract of Use of Genetic Heritage and Benefit-Sharing, the disposal on:
I - object, its elements, quantification of sample and intended use;
II - long term;
III - form of fair and equitable sharing of benefits;
IV - rights and responsibilities of the parties;
V - intellectual property rights;
VI - conditions of access to technology and technology transfer;
VII - termination;
VIII - penalties;
IX - forum.

Chapter VIII ADMINISTRATIVE SANCTIONS
Art. 27. An administrative offense against the genetic heritage or traditional knowledge associated with any action or omission that violates the rules set forth in this Provisional Measure.
§ 1 Administrative violations shall be punished as prescribed in the regulations under this Provisional Measure, with the following sanctions:
I - warning;
II - fine;
III - seizure of products and components of the genetic heritage;
IV - suspension of sales of the product;
V - embargo of the activity;
VI - partial or total prohibition of the establishment, activity or undertaking;
VII - suspension of registration, license or authorization required by law;
VIII - cancellation of registration, license or authorization required by law;
IX - loss or restriction of tax incentives and benefits granted by the government;
X - loss or this suspension of participation in financing lines in official credit establishments;
XI - intervention in the establishment;
XII - prohibition of contracting with the Public Administration for a period of up to five years.
§ 2 The material or product and the instruments referred to in the preceding paragraph shall have their destination set by the competent body, including its destruction.
§ 3 The sanctions provided for in this Article shall be applied by the agency that deals with art. 11, in the established procedure in the regulations under this Provisional Measure, without prejudice to civil or criminal penalties applicable.
§ 4 The fines mentioned in item II of § 1 of this article shall be arbitrated by the competent authority according to the seriousness of the offense and the regulations, ranging from R $ 200.00 (two hundred reais) to R $ 100,000 , 00 (one hundred thousand reais), when dealing with individuals.
§ 5 If the offense is committed by a legal entity, or your competition, the fine will be $ 10,000.00 (ten thousand reais) to R $ 50,000,000.00 (fifty million reais), arbitrated by the competent authority , according to seriousness of the offense, according to the regulations.
Chapter IX


FINAL PROVISIONS Art. 28. The granting of industrial property rights by the competent bodies upon process or product obtained from the genetic heritage component samples is subject to the observance of this Provisional Measure, The applicant must inform the origin of genetic material and the genetic knowledge and associated traditional knowledge, where applicable.
Art. 29. The surveillance, interception and seizure of the genetic heritage component sample accessed at variance with the provisions of this Provisional Measure shall be exercised by federal agencies, according to that provided in the regulations, and may also such activities are decentralized, through agreements.
Art. 30. For the provision of services under this provisional measure will be charged fee, whose amount and payment process will be established in holder act of the Federal Public Administration body that are linked such services.
Sole paragraph. The proceeds from the consideration that this article, constituting revenue of the agency that deals with art. 11, the application of which will be defined by it in resolution.
Art. 31. A portion of the profits and royalties owed to the Union, resulting from the economic exploitation of processes or products developed from genetic heritage components of the sample, as well as fines and damages that this Provisional Measure will be allocated to the National Fund Environment, established by Law No. 7,797, of July 10, 1989, the Naval Fund, established by Decree No. 20923 of January 8, 1932, and the National Fund for Scientific and Technological Development, created by Decree-Law No. 719 of 31 July 1969 and re-established by Law No. 8,172, of January 18, 1991, pursuant to the regulations.
Sole paragraph. The resources mentioned in this article will be used in the conservation of biological diversity, promoting sustainable use of its components, fostering scientific research, technological development associated with genetic resources and the training of human resources.
Art. 32. The Government shall regulate this Provisional Measure up to December 30, 2000.
Art. 33. The provisions of this Provisional Measure does not apply to the matters covered by Law No. 8,974, of January 5, 1995.
Art. 34 are hereby validated the acts performed pursuant to Provisional Measure No. 2052-2 of 28 August 2000.
Art. 35. This Provisional Measure shall enter into force on the date of its publication.
Brasilia, September 27, 2000; 179th of Independence and 112th of the Republic.
Cardoso Mota Sardenberg
Ronaldo
José Sarney Filho

Related Laws