Provisional measure on access to genetic resources and traditional knowledge

Brazil (2001, in force as provisional measure)

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BRAZIL - PROVISIONAL MEASURE No. 2.186-16 OF AUGUST 23, 2001

Enacting provisions under paragraphs (1)(ii) and (4) of Article 225 of the Constitution, Articles 1, 8(j), 10(c), 15 and 16(3) and (4) of the Convention on Biological Diversity, regulating access to the genetic heritage, protection of and access to associated traditional knowledge, sharing of benefits and access to and transfer of technology for their conservation and use, and introducing other provisions.

THE PRESIDENT OF THE REPUBLIC, by virtue of the powers invested in him by
Article 62 of the Constitution, adopts the following Provisional Measure, with force of law:

Chapter I

GENERAL PROVISIONS

Article 1. This Provisional Measure provides for the benefits, rights and obligations concerning:

I. access to components of the genetic heritage on the national territory, on the continental shelf and in the exclusive economic zone for purposes of scientific research, technological development or biological prospection;
II. access to traditional knowledge relating to the genetic heritage that is relevant to the conservation of biological diversity, the integrity of the Country’s genetic heritage and the use of its components;
III. the fair and equitable sharing of the benefits deriving from exploitation of components of the genetic heritage and the associated traditional knowledge; and
IV. access to and transfer of technology for the conservation and use of biological diversity.

§1. Access to components of the genetic heritage for purposes of scientific research, technological development or bioprospection shall be had in accordance with this Provisional Measure, without prejudice to any material or immaterial property rights that might subsist in components of the genetic resources accessed, or the location where access is had.

§2. Access to components of the genetic heritage on the continental shelf shall be subject to the provisions of Law No. 8.617 of January 4, 1993.

Article 2. Access to components of the genetic heritage within national boundaries shall only be had with the authority of the Union and its use, marketing and exploitation for whatever purpose shall be subject to inspection, restrictions and benefit-sharing on the terms and conditions established in this Provisional Measure and in the regulations under it.

Article 3. This Provisional Measure does not apply to human genetic resources.

Article 4. The exchange and dissemination of components of the genetic heritage and associated traditional knowledge practised within indigenous and local communities for their own benefit and based on customary usage are preserved.

Article 5. Access to the genetic heritage for purposes that are harmful to the environment and to human health, and for the development of biological and chemical weapons, is prohibited.

Article 6. If at any time there is scientific evidence to suggest a risk of serious and irreversible damage to biological diversity resulting from activities provided for in this Provisional Measure, the public authorities, acting through the Council for the Management of the Genetic Heritage provided for in Article 10, shall, on the basis of technical opinion and criteria, decide on measures to prevent the damage, which may include suspension of the activity, due regard being had to the competence of the body responsible for the biological security of genetically modified organisms.

CHAPTER II

Definitions

Article 7. In addition to the concepts and standard definitions in the Convention on Biological Diversity, the following definitions shall apply for the purposes of this Provisional Measure:

I. Genetic heritage: information of genetic origin contained in samples of all or part of plant, fungal, microbial or animal specimens, in the form of molecules and substances deriving from the metabolism of such living beings and extracts obtained from such organisms, live or dead, encountered in situ, including domestic situations, or kept in ex situ collections after in situ collection within the national territory, on the continental shelf or in the exclusive economic zone;
II. Associated traditional knowledge: information or individual or collective practices of an indigenous or local community having real or potential value and associated with the genetic heritage;
III. Local community: human group, including remnants of Quilombo communities, distinguished by its cultural conditions, that traditionally organizes itself throughout successive generations and through its own customs and preserves its social and economic institutions;
IV. Access to the genetic heritage: acquisition of samples of components of the genetic heritage for purposes of scientific research, technological development or bioprospection, with a view to its application in industry or elsewhere;
V. Access to associated traditional knowledge: acquisition of information pertaining to knowledge or individual or collective practices, associated with the genetic heritage, of an indigenous or local community for purposes of scientific research, technological development or biological prospection, with a view to its application in industry or elsewhere;
VI. Access to and transfer of technology: action whose purpose is access to and the development and transfer of technology for the preservation and use of biological diversity or technology developed from samples of components of the genetic heritage or from associated traditional knowledge;
VII. Bioprospection: exploratory activity aimed at identifying components of the genetic heritage and information on associated traditional knowledge with potential for commercial use;
VIII. Species threatened with extinction: species carrying a high risk of disappearance from nature in the near future, and recognized as such by the competent authority;
IX. Domesticated species: a species in whose course of evolution human beings have intervened in order to meet their own needs;
X. Authorization of Access and Dispatch: document that allows, under specific conditions, access to samples of components of the genetic heritage and the dispatch thereof to a receiving institution, and access to associated traditional knowledge;
XI. Special Authorization of Access and Dispatch: document that allows, under specific conditions, access to samples of components of the genetic heritage and the dispatch thereof to a receiving institution, and access to associated traditional knowledge, for a period of up to two years, renewable for equal periods;
XII. Instrument of Material Transfer: formal document to be signed by the receiving institution before any samples of components of the genetic heritage are dispatched, with a mention where appropriate of whether access has been had to associated traditional knowledge;
XIII. Contract for Use of the Genetic Heritage and Benefit-Sharing: multilateral legal instrument which gives the particulars of the parties, the purpose and the conditions of access to and dispatch of components of the genetic heritage and associated traditional knowledge, and also the conditions for the sharing of benefits;
XIV. Ex situ state: maintenance of samples of components of the nation’s genetic resources outside their natural habitat, in collections of live or dead material.

CHAPTER III

PROTECTION OF ASSOCIATED
TRADITIONAL KNOWLEDGE

Article 8. Traditional knowledge of indigenous and local communities relating to the genetic heritage is protected by this Provisional Measure against illegal use and exploitation and other actions that are harmful or have not been authorized by the Management Council referred to in Article 10 or by an accredited institution.

I. The State recognizes the right of indigenous and local communities to decide on the use of their traditional knowledge associated with the genetic heritage, as provided in this Provisional Measure and the regulations under it.
II. The traditional knowledge associated with genetic heritage that is covered by this Provisional Measure encompasses the cultural heritage of Brazil and may be subject to a cadastral record, as directed by the Management Council or provided in specific legislation.
III. The protection afforded by this Provisional Measure may not be interpreted in such a way as to impede the preservation, use and development of traditional knowledge of an indigenous or local community.
IV. The protection hereby instituted shall not affect, prejudice or limit rights pertaining to intellectual property.

Article 9. Indigenous or local communities that create, develop, hold or preserve traditional knowledge associated with the genetic heritage are guaranteed the right to:

I. have the origin of the access to traditional knowledge mentioned in all publications, uses, exploitation and disclosures;
II. prevent unauthorized third parties from:
(a) using or carrying out tests, research or investigations relating to associated traditional knowledge;
(b) disclosing, broadcasting or re-broadcasting data or information that incorporate or constitute associated traditional knowledge;
III. derive profit from economic exploitation by third parties of associated traditional knowledge the rights in which are owned by the community as provided in this Provisional Measure.

Sole Paragraph: For the purposes of this Provisional Measure, any traditional knowledge associated with the genetic heritage may be owned by the community, even if only one single member of the community holds that knowledge.

CHAPTER IV

INSTITUTIONAL COMPETENCIES
AND POWERS

Article 10. The Council for the Management of Genetic Resources is hereby created within the Ministry of the Environment, being deliberative and normative in nature and composed of representatives of organs and agencies of the Federal Public Administration that are competent to perform the various actions provided for in this Provisional Measure.

§1. The Management Council shall be presided over by the representative of the Ministry of the Environment.

§2. The composition and action of the Management Council shall be laid down in the regulations.

Article 11. The Management Council shall be competent to:

I. coordinate the implementation of policies for the management of the genetic heritage;
II. establish:
(a) technical standards;
(b) criteria for authorization of access and dispatch;
(c) directives for drafting the Contract for Use of the Genetic Heritage and Benefit-Sharing;
(d) criteria for the creation of a database for recording information on associated traditional knowledge;
III. take part, in concert with Federal bodies or by agreement with other institutions, in the work of accessing and dispatching samples of components of the genetic heritage, and accessing associated traditional knowledge;
IV. deliberate on:
(a) authorization of access and dispatch of samples of components of the genetic heritage, subject to the prior consent of the owner;
(b) authorization of access to associated traditional knowledge, subject to the prior consent of the owner;
(c) special authorization of access to and dispatch of samples of components of the genetic heritage for a national institution, whether public or private, which carries on research and development activities in the areas of biology and related subjects, and for a national university, whether public or private, for a term of up to two years, renewable for equal periods, as provided in the regulations;
(d) special authorization of access to associated traditional knowledge for a national institution, whether public or private, that carries on research and development activities in the biological and related fields, and for a national university, whether public or private, for a term of up to two years, renewable for equal periods, as provided in the regulations;
(e) accreditation of a national public research and development institution or Federal public management institution for authorizing another national institution, whether public or private, which carries on research and development activities in the biological and related fields, to:
1. access samples of components of the genetic heritage and associated traditional knowledge;
2. dispatch samples of components of the genetic heritage to a national institution, whether public or private, or to an institution with its headquarters abroad;
(f) accreditation of a national public institution as a depositary of samples of components of the genetic heritage.
V. approve Contracts for the Use of the Genetic Heritage and Benefit-Sharing as complying with the requirements of this Provisional Measure and the regulations under it;
VI. promote discussion and public consultation on the subjects provided for in this Provisional Measure;
VII. function as a higher court of appeal in relation to decisions of an accredited institution and acts resulting from the application of this Provisional Measure;
VIII. approve its statutes.

§1. Decisions of the Management Council may be referred to the plenary session, as provided in the regulations.

§2. The Management Council may organize itself into subject groups to prepare decisions of the plenary session.

Article 12. The activity of collecting components of the genetic heritage and access to associated traditional knowledge that contributes to the advancement of bioprospection shall, when it involves the participation of a foreign legal entity, require authorization by the body responsible for national policy on scientific and technological research, subject to the terms of this Provisional Measure and the laws in force.

Sole Paragraph. The aforesaid authorization shall conform to the technical standards laid down by the Management Council, which shall oversee such activities.

Article 13 . The Chairman of the Management Council shall be competent to sign, in the name of the Union, the Contract for the Use of the Genetic Heritage and Benefit-Sharing.

§1. While retaining the competence specified in the heading of this Article, the Chairman of the Management Council may delegate that competence to the incumbent of a Federal public research and development institution or Federal public management institution, depending on the area of activity with which it is concerned.

§2 Where the institution mentioned in the preceding paragraph has an interest in the contract, the contract shall be signed by the Chairman of the Management Council.

Article 14. The accredited institution referred to in Article 11.IV(e) 1 and 2 of this Provisional Measure may be accorded one or more of the following powers, as directed by the Management Council:

I. to analyze applications and to issue authorizations to third parties for:
(a) access to samples of components of the genetic heritage existing in situ within the national territory, on the continental shelf and in the exclusive economic zone, subject to the prior consent of the owners;
(b) access to associated traditional knowledge, subject to the prior consent of the owners from the area;
(c) dispatch of samples of components of the genetic heritage to a national institution, whether public or private, or to an institution with its headquarters abroad;
II. With Federal bodies, or by agreement with other institutions, to take part in the work of access to and dispatch of samples of components of the genetic heritage and access to associated traditional knowledge;
III. to create and maintain:
(a) a register of ex situ collections, as provided in Article 18 of this Provisional Measure;
(b) a database for recording information obtained during the collection of samples of components of the genetic heritage;
(c) a database of Authorizations of Access and Dispatch, Terms of Transfer of Material and Contracts for the Use of Genetic Heritage and Benefit-Sharing, as provided in the regulations;
IV. to disclose periodically a list of Authorizations of Access and Dispatch, Terms of Transfer of Material and Contracts for the Use of the Genetic Heritage and Benefit-Sharing;
V. to take part in the implementation of Terms of Transfer of Material and Contracts for the Use of the Genetic Heritage and Benefit-Sharing in the case of processes that it has itself authorized.

§1. An accredited institution shall every year report fully on its activity to the Management Council and supply a copy of its databases to the executive body provided for in Article 15.

§2. An accredited institution under Article 11 shall comply with the terms of this Provisional Measure, the regulations under it and the decisions of the Management Council, on pain of forfeiture of its accreditation and liability also, where applicable, to the penalties provided for in Article 30 and in the relevant legislation.

Article 15. The creation is authorized, within the Ministry of the Environment, of an executive body which shall exercise the function of executive secretariat of the Management Council provided for in Article 10 of this Provisional Measure, and which shall have the following powers, among others:

I. to implement the resolutions of the Management Council;
II. to give support to the accredited institutions;
III. to issue, in accordance with the resolutions of the Management Council and in its name
(a) Authorizations of Access and Dispatch;
(b) Special Authorizations of Access and Dispatch;
IV. to take part, in concert with other Federal bodies, in the work of accessing and dispatching samples of components of the genetic heritage and accessing associated traditional knowledge;
V. to give accreditation, in accordance with resolutions of the Management Council and in its name, to a national public research and development institution or a Federal public management institution for authorizing a national institution, whether public or private, to:
(a) access samples of components of the genetic heritage and associated traditional knowledge;
(b) dispatch samples of components of the genetic heritage to a national institution, whether public or private, or to an institution with its headquarters abroad, subject to the requirements of Article 19 of this Provisional Measure;
VI. to give accreditation, in accordance with resolutions of the Management Council and in its name, to a national public institution as depositary of samples of components of the genetic heritage;
VII. to register Contracts for Use of the Genetic Heritage and Benefit-Sharing, following their approval by the Management Council;
VIII. to disclose a list of species designated for facilitated exchange in international agreements, including those relating to food safety, of which the country is a signatory, in accordance with Article 19.II of this Provisional Measure;
IX. to create and maintain:
(a) a register of ex situ collections, as provided in Article 18;
(b) a database for recording information obtained during the collection of samples of components of the genetic heritage;
(c) a database of Authorizations of Access and Dispatch, Terms of Transfer of Material and Contracts for Use of the Genetic Heritage and Benefit-Sharing;
X. to disclose periodically a list of Authorizations of Access and Dispatch, Terms of Transfer of Material and Contracts for Use of the Genetic Heritage and Benefit-Sharing.

CHAPTER V

ACCESS AND DISPATCH

Article 16. Access to components of the genetic heritage existing in situ within the national territory, on the continental shelf or in the exclusive economic zone, and to associated traditional knowledge, shall be had by collection of samples and information respectively, and authorization shall only be given to a national institution, whether public or private, that carries on research and development activities in the biological and related fields by prior authorization, as provided in this Provisional Measure.

§1. The person responsible for the expedition to collect samples shall, at the end of his work in each area accessed, sign with the owner or representative thereof a declaration listing the material accessed, as provided in the regulations.

§2. In exceptional cases, where the owner of the area or his representative was not identified or located when the expedition to collect samples took place, the declaration listing the material accessed shall be signed by the person responsible for the expedition and sent to the Management Council.

§3. A representative sub-sample of each accessed population constituting a component of the genetic heritage shall be deposited ex situ with an accredited depositary, described in
Article 11.IV(f) of this Provisional Measure, as provided in the regulations.

§4. When there is a prospect of commercial use, in situ access to samples of components of the genetic heritage and to associated traditional knowledge may only occur after the Contract for Use of the Genetic Heritage and Benefit-Sharing has been signed.

§5. If potential for economic use has been identified in either a product or a process, whether or not it qualifies for intellectual protection on the basis of a sample of a component of the genetic heritage and information derived from associated traditional knowledge, accessed by virtue of authorization that did not establish that hypothesis, the benefiting institution is obliged to communicate with the Management Council, or the institution with which the process of access and dispatch originated, for execution of the Contract for the Use of the Genetic Heritage and Benefit-Sharing.

§6. Participation of a foreign legal entity in an expedition to collect samples of components of the genetic heritage in situ and to gain access to associated traditional knowledge shall only be authorized when it is to be in conjunction with a national public institution, which shall compulsorily be responsible for the coordination of activities, and provided that all institutions involved carry out research and development activities in biological and other related fields.

§7. Research on components of the genetic heritage shall preferably be done on the national territory.

§8. The Authorization of Access to and Dispatch of samples of components of the genetic heritage in the case of species that are strictly endemic or threatened with extinction shall be dependent on the prior consent of the competent body.

§9. Authorization of Access and Dispatch shall be granted with the prior consent of:

I. the indigenous community involved, the views of its official representative body having been heard where access occurs on indigenous territory;
II. the competent body where access occurs in a protected area;
III. the owner where access occurs on private land;
IV. the National Defense Council where access occurs in an area indispensable to national security;
V. the maritime authority where access occurs in Brazilian territorial waters, on the continental shelf or in the exclusive economic zone.

§10. The holder of an Authorization of Access and Dispatch under §9.1 to V of this Article is responsible for indemnifying the owner of the area for any damage or harm that has been duly proved.

§11. An institution holding a Special Authorization of Access and Dispatch shall send to the Management Council the consents referred to in paragraphs §8 and §9 of this Article before or on the occasion of collection expeditions to be carried out during the period of validity of the Authorization, and failure to do so shall result in its cancellation.

Article 17. In the event of relevant public interest, as defined by the Management Council, entry into a public or private area for access to samples of components of the genetic heritage shall not require prior authorization by its owners, who shall be assured of the benefits provided for in Articles 24 and 25 of this Provisional Measure.

§1. In the case provided for in the heading of this Article the indigenous community, local community or owner shall be given advance notice.

§2. In cases involving indigenous lands, the provisions of Article 231(6) of the Federal Constitution shall apply.

Article 18. The ex situ preservation of samples of components of the genetic heritage shall take place on the national territory, provided that it may take place abroad at the discretion of the Management Council.

§1. Ex situ collections of samples of components of the genetic heritage must be registered with the executive body of the Management Council, as provided in the regulations.

§2. The Management Council may delegate registration under paragraph (1) of this Article to one or more institutions accredited as provided in Article 11.IV(d) and (e) of this Provisional Measure.

Article 19. The dispatch of samples of components of the genetic heritage by a national institution, whether public or private, to another national institution, whether public or private, shall make use of material held ex situ subject to information on the intended use and cumulative compliance with the following conditions, in addition to others that the Management Council might establish:

I. deposit of a representative sub-sample of components of the genetic heritage in a collection maintained by an accredited institution, even if the provisions of Article 16§3 of this Provisional Measure have not been complied with;
II. where samples of components of the genetic heritage have been accessed in situ before the publication of this Provisional Measure, the deposit referred to in the preceding paragraph shall be made in the form accessed, if still available, as provided in the regulations;
III. provision of information obtained during collection of samples of components of the genetic heritage for recording in the database mentioned in Article 14.III(b) and Article 15.IX(b) of this Provisional Measure;
IV. prior signature of the Terms of Transfer of Material.

§1. Whenever there is a prospect of commercial use of a product or process resulting from the use of components of the genetic heritage, the Contract for Use of the Genetic Heritage and Benefit-Sharing shall be signed in advance.

§2. Dispatch of samples of components of the genetic heritage in the case of species designated for facilitated exchange in international agreements, including those on food safety, of which the country is a signatory, shall be carried out in accordance with the conditions defined therein, the requirements of such agreements being constantly observed.

§3. Dispatch of any sample of components of the genetic heritage by a national institution, whether public or private, to an institution with its headquarters abroad, shall make use of
ex situ material, subject to information on the intended use, prior authorization by the Management Council or the accredited institution and cumulative compliance with all the conditions laid down in subparagraphs I to IV and paragraphs §1 and §2 of this Article.

Article 20. The format of the Terms of Transfer of Material shall be approved by the Management Council.

CHAPTER VI

ACCESS TO AND TRANSFER OF
TECHNOLOGY

Article 21. The institution receiving samples of components of the genetic heritage or associated traditional knowledge shall facilitate access to and transfer of technology for the preservation and use of that heritage or knowledge for the national institution responsible for access and dispatch of samples and information on the knowledge, or an institution specified by it.

Article 22. Access to and transfer of technology between the national research and development institution, whether public or private, and an institution with its headquarters abroad may be achieved, among other activities, by means of:

I. scientific research and technological development;
II. basic and specialized training of human resources;
III. exchange of information;
IV. exchange between the national research institution and the research institution with its headquarters abroad;
V. consolidation of the infrastructure for scientific research and technological development;
VI. economic exploitation, in partnership, of a process or product derived from the use of components of the genetic heritage; and
VII. establishment of a technology-based joint venture.

Article 23. A company that invests in research and development activity in the Country in the process of affording access to and transfer of technology to a national institution, whether public or private, responsible for access to and dispatch of samples of components of the genetic heritage and for access to information on associated traditional knowledge shall qualify for tax incentives for technological training in industry, agriculture and livestock breeding and for other incentives in accordance with relevant legislation.

CHAPTER VII

BENEFIT-SHARING

Article 24. The benefits arising from economic exploitation of a product or process developed from samples of components of the genetic heritage and associated traditional knowledge, obtained by a national institution or an institution with its headquarters abroad shall be shared in a fair and equitable way between the contracting parties, as provided in the regulations and relevant legislation.

Sole paragraph. When the Union is not a party to the Contract for Use of Genetic Heritage and Benefit-Sharing, it shall be assured where applicable of a share in the benefits referred to in the heading of this Article, as provided in the regulations.

Article 25. The benefits derived from the economic exploitation of a product or process developed from samples of the genetic heritage or associated traditional knowledge may consist of the following among other things:

I. division of profits;
II. payment of royalties;
III. technology access and transfer;
IV. unrestricted licensing of products or services; and
V. training of human resources.

Article 26. Economic exploitation of a product or process developed from samples of components of the genetic heritage or associated traditional knowledge that have been accessed in a manner not conforming to the terms of this Provisional Measure shall make the guilty party liable to payment of an indemnity equivalent to a minimum of twenty per cent of the gross invoiced amount obtained through the marketing of the product or of royalties obtained from third parties by the guilty party as a result of the licensing of the product or process or the use of the technology, whether or not protected by intellectual property, without prejudice to administrative sanctions and appropriate penalties.

Article 27. The Contract for Use of the Genetic Heritage and Benefit-Sharing shall mention and clearly identify the contracting parties, being on the one hand the owner of the public or private area or the representative of the indigenous community and the official indigenous body, or the representative of the local community and, on the other hand, the national institution authorized to have access and the receiving institution.

Article 28. Essential clauses in the Contract for Use of the Genetic Heritage and
Benefit-Sharing, as provided in the regulations, and without prejudice to others, are those that relate to:

I. purpose, elements, quantification of samples and intended use;
II. duration;
III. method of fair and equitable sharing of benefits and, where applicable, access to and transfer of technology;
IV. rights and responsibilities of the parties;
V. intellectual property rights;
VI. cancellation;
VII. penalties;
VIII. jurisdiction in Brazil.

Sole Paragraph. When the Union is a party to the contract referred to in the heading of this Article, it shall be governed by the provisions of public law.

Article 29. Contracts for Use of the Genetic Heritage and Benefit-Sharing shall be submitted to the Management Council for registration and shall only become effective once approved.

Sole paragraph. Contracts for Use of the Genetic Heritage and Benefit-Sharing that are signed in a manner not conforming to the terms of this Provisional Measure and the regulations shall be null and devoid of legal effect.

CHAPTER VIII

ADMINISTRATIVE SANCTIONS

Article 30. Any act or omission that contravenes the terms of this Provisional Measure and other relevant legal provisions shall be considered an administrative offense against the genetic heritage and associated traditional knowledge.

§1. Administrative offenses shall be punished, as provided in the regulations under this Provisional Measure, with the following sanctions:

I. a warning;
II. a fine;
III. confiscation of samples of components of the genetic heritage and of instruments used for collecting or processing them, or of products obtained on the basis of information relating to associated traditional knowledge;
IV. confiscation of products derived from samples of components of the genetic heritage or associated traditional knowledge;
V. suspension of sales of the product derived from the sample of components of the genetic heritage or the associated traditional knowledge, and confiscation thereof;
VI. a ban on activities;
VII. partial or total prohibition of the establishment, activity or undertaking;
VIII. suspension of registration, patent, license or authorization;
IX. cancellation of registration, patent, license or authorization;
X. loss or restriction of tax incentives and benefits accorded by the Government;
XI. loss or suspension of financing arrangements with an official credit establishment;
XII. intervention in the establishment;
XIII. a ban on signing contracts with public authorities for a period of up to five years.

§2. The fate of the samples, products and instruments referred to in subparagraphs III, IV
and V of paragraph §1 of this Article shall be determined by the Management Council.

§3. Sanctions provided for in this Article shall be applied according to the procedure set out in the regulations under this Provisional Measure, without prejudice to civil sanctions or appropriate penalties.

§4. The fines referred to in subparagraph II of paragraph §1 of this Article shall be determined by the competent authority according to the gravity of the offense and as provided in the regulations, and may vary from R$200 (two hundred reals) to R$100,000
(one hundred thousand reals) in the case of a natural person.

§5. If the offense was committed by a legal entity or with its consent, the fine shall be from R$10,000 (ten thousand reals) to R$50,000,000 (fifty million reals), as determined by the competent authority, according to the gravity of the offense and as provided in the regulations.

§6. In the event of a repeat offense, the fine shall be doubled.

CHAPTER IX

FINAL PROVISIONS

Article 31. The grant of industrial property rights by the competent bodies for a process or product obtained using samples of components of the genetic heritage is contingent on the observance of this Provisional Measure, the applicant being obliged to specify the origin of the genetic material and the associated traditional knowledge, as the case may be.

Article 32. The competent Federal bodies shall carry out inspection, interception and confiscation of samples of components of the genetic heritage or of products obtained from information on associated traditional knowledge that have been accessed in a manner not conforming to the provisions of this Provisional Measure, it being possible to decentralize those activities by agreement, as provided in the regulations.

Article 33. The portion of income and royalties payable to the Union as a result of the economic exploitation of a process or product developed on the basis of a sample of components of the genetic heritage, as well as the value of fines and indemnities provided for in this Provisional Measure, shall be credited to the National Environment Fund created 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 Decree-Law No. 719 of July 31, 1969, and confirmed by Law No. 8.172 of January 18, 1991, as provided in the regulations.

Sole Paragraph. The resources to which this Article refers shall be used exclusively for the conservation of biological diversity, recovery and the creation and maintenance of depositary institutions, for the furtherance of scientific research, for technological development associated with genetic resources and for the training of human resources associated with the conduct of activities relating to the use and conservation of genetic resources.

Article 34. Any person using or economically exploiting components of the genetic heritage and associated traditional knowledge shall ensure that or her activities conform to the standards laid down in this Provisional Measure and the regulations under it.

Article 35. The Government shall regulate this Provisional Measure up to December 30, 2001.

Article 36. The provisions of this Provisional Measure shall not apply to material regulated by Law No. 8.974 of January 5, 1995.

Article 37. Acts based on Provisional Measure No. 2.186-15 of June 26, 2001, shall remain valid.

Article 38. This Provisional Measure shall enter into force on the date of its publication.

Brasilia, August 23, 2001; 180th year of Independence and 113th year of the Republic.

FERNANDO HENRIQUE CARDOSO
José Gregori
José Serra
Ronaldo Mota Sardenberg
José Sarney Filho