PROVISIONAL ACT NO 2,186-16, DATED AUGUST 23, 2001.
Regulates item II from Paragraph 1
and Paragraph 4 of Article 225 of
the Constitution, Articles 1, 8, item
"j", 10, item "c", 15 and 16, items
3 and 4 of the Convention on
Biological Diversity, provides for
the access to genetic heritage,
protection and access to associated
traditional knowledge, benefitsharing and access to and transfer
of technology for its conservation
and use, and makes other
provisions.
THE PRESIDENT OF THE REPUBLIC, making use of the prerogatives vested upon him
by Article 62 of the Constitution, adopts the following legally binding Provisional Act:
TITLE I
GENERAL PROVISIONS
Article 1. This Provisional Act provides for assets, rights and obligations concerning:
I - Access to components of genetic heritage existing within the Brazilian territory, on the
continental shelf and in the exclusive economic zone for purposes of scientific research,
technological development or bioprospecting;
II - Access to traditional knowledge associated to genetic heritage, related to the
conservation of biological diversity, to the integrity of the country's genetic heritage and
to the use of its components;
III - The fair and equitable sharing of the benefits arising from the use of the genetic
heritage component and the associated traditional knowledge; and
IV - Access to technology and transfer of technology for the conservation and use of
biological diversity.
Paragraph 1st Access to components of genetic heritage for the purpose of scientific
research, technological development or bioprospecting shall be carried out under the
terms of this Provisional Act, without prejudice to material or intangible property rights
that are incident upon the accessed genetic heritage components or upon the site of its
occurrence.
Paragraph 2o Access to components of genetic heritage existing on the continental shelf
shall comply with that provided for in Law No. 8,617, dated January 4, 1993.
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Article 2o Access to genetic heritage existing in the country shall only be take place with
an authorization from the Federal Government and its use, commercialization and
employment for any purpose shall be submitted to inspection, restrictions and sharing of
benefits in the terms and conditions established in this Provisional Act and its
complementary legislation.
Article 3 o This Provisional Act does not apply to human genetic heritage.
Article 4 o The exchange and dissemination of components of genetic heritage and of
associated traditional knowledge practiced within indigenous communities and local
communities for their own benefit and based on customary practices is hereby preserved .
Article 5 o Access to genetic heritage is hereby prohibited for practices that are harmful to
the environment and to human health and for the development of biological and chemical
weapons.
Article 6 o At any moment, in the light of scientific evidence denoting the risk of serious
and irreparable damage to biological diversity, arising from activities carried out in the
terms of this Provisional Act, the Government, through the Genetic Heritage Management
Council, provided for in Article 10, based on criteria and technical assessments, shall
determine measures intended to prevent such damage and may even stop the activity,
observing the mandate of the agency responsible for the biosafety of genetically modified
organisms.
TITLE II
DEFINITIONS
Article 7o In addition to the concepts and definitions contained in the Convention on
Biological Diversity, the following terms are defined for the purposes of this Provisional
Act:
I - Genetic heritage: information of genetic origin, contained in samples of all or part of a
plant, fungal, microbial or animal species, in the form of molecules and substances
originating in the metabolism of these living beings, and in extracts obtained from in situ
conditions, including domesticated, or kept in ex situ collections, if collected from in situ
conditions, within the Brazilian territory, on the continental shelf or in the exclusive
economic zone;
II - Associated traditional knowledge: individual or collective information or practice of
the indigenous community or local community, with real or potential value, associated to
genetic heritage;
III - Local community: human group, including descendants of Quilombo communities,
differentiated by its cultural conditions, which is, traditionally, organized along successive
generations and with its own customs, and preserves its social and economic institutions;
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IV - Access to genetic heritage: acquisition of samples of a genetic heritage components for
the purpose of scientific research, technological development, or bioprospecting, with a
view to its industrial or other application;
V - Access to associated traditional knowledge: acquisition of information on individual
or collective knowledge or practice associated to genetic heritage, from an indigenous
community or local community, for the purpose of scientific research, technological
development or bioprospecting, with a view to its industrial or other application;
VI - Access to and transfer of technology: an action that aims to ensure access to,
development and transfer of technology for the conservation and utilization of biological
diversity or technology developed from samples of genetic heritage components or
associated traditional knowledge;
VII - Bioprospecting: an exploratory activity that aims to identify genetic heritage
components and information on associated traditional knowledge, with potential for
commercial use;
VIII - Endangered species: species with a high risk of disappearing from nature in the near
future, recognized as such by the competent authority;
IX - Domesticated species: species in which the evolutionary process has been influenced
by humans to meet their needs;
X – Authorization for Access and Shipment: the document that allows, under specific
conditions, access to samples of genetic heritage components and its shipment to the
recipient institution and the access to associated traditional knowledge;
XI – Authorization for Special Access and Shipment: the document that allows, under
specific conditions, access to samples of genetic heritage components and its shipment to
the recipient institution and the access to associated traditional knowledge, for a period of
up to two years, renewable for equal periods;
XII - Material Transfer Agreement: accession instrument to be signed by the recipient
institution before shipment of any sample of genetic heritage components, indicating,
when appropriate, if there was access to associated traditional knowledge;
XIII - Contract for Use of Genetic Heritage and Benefit-Sharing: the multilateral legal
instrument that identifies the Parties, the object, the conditions of access and of shipment
of genetic heritage components and of associated traditional knowledge, as well as the
conditions for benefit-sharing;
XIV - Ex situ conditions: maintaining samples of genetic heritage components outside of
its natural habitat, in living or preserved collections.
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TITLE III
PROTECTION TO ASSOCIATED TRADITIONAL KNOWLEDGE
Article 8 o This Provisional Act protects the traditional knowledge of the indigenous
communities and of the local communities, associated to genetic heritage, from illicit use
and exploitation and other harmful actions or those actions not authorized by the
Brazilian Council referred to in Article 10, or by an accredited institution.
Paragraph 1 o The State recognizes the right of the indigenous communities and of the
local communities to decide on the use of their traditional knowledge related to the
genetic heritage of the country, in the terms of this Provisional Act and its complementary
legislation.
Paragraph 2o The traditional knowledge related to genetic heritage provided for by this
Provisional Act is an integral part of the Brazilian cultural heritage and may be registered,
as provided for the Brazilian Council or specific legislation.
Paragraph 3o The protection conferred by this Provisional Act may not be interpreted so
as to become an obstacle to the preservation, utilization and development of traditional
knowledge of an indigenous community or a local community.
Paragraph 4o The protection hereby established shall not affect, damage or limit rights
related to intellectual property.
Article 9 o The indigenous communities and local communities that create, develop, hold
or conserve traditional knowledge associated to genetic heritage are assured the right to:
I - Have acknowledged the origin of the access to the traditional knowledge in all
publications, uses, exploitations and dissemination;
II - Prevent non-authorized third-parties to:
a) Use, test, research or make commercial use, in regard to associated traditional
knowledge;
b) Disseminate, transmit or forward data or information that make up associated
traditional knowledge, or part thereof;
III - Receive benefits from the economic use by third parties, directly or indirectly, of
associated traditional knowledge to which they hold rights, in accordance with this
Provisional Act.
Sole Paragraph. For the purposes of this Provisional Act, any traditional knowledge
related to genetic heritage may be deemed to be held by the community even if only one
member of this community holds this knowledge.
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TITLE IV
INSTITUTIONAL MANDATE AND COMPETENCE
Article 10. The Genetic Heritage Governing Council is hereby established, under the
Ministry of Environment, a regulatory and deliberative
body, composed of
representatives of Federal Government entities responsible for the various actions covered
by this Provisional Act.
Paragraph 1o The Management Council shall be chaired by the representative of the
Ministry of Environment.
Paragraph 2 o The Management Council shall have its composition and operation
provided for in complementary legislation.
Article 11. The Management Council is responsible for:
I - Coordinating implementation of genetic heritage management policies;
II - Establishing:
a) Technical standards;
b) Criteria for access and shipment authorizations;
c) Guidelines for drafting the Contract for Use of Genetic Heritage and Benefit-Sharing;
d) Criteria for creation of a database for recording information on associated traditional
knowledge;
III - Overseeing, in coordination with other federal bodies, or by means of an agreement
with other institutions, the activities of access and shipment of samples of genetic heritage
components and access to associated traditional knowledge;
IV - Deliberating on:
a) Authorizations for access and shipment of samples of genetic heritage components,
with prior consent of its holder;
b) Authorizations for access to associated traditional knowledge, with the prior consent of
its holder;
c) Special authorizations for access and shipment of samples of a genetic heritage
components to the Brazilian institution, public or private, that carries out research and
development activities in biological and related areas, and to a Brazilian university, public
or private, for a period of up to two years, renewable for equal periods, in accordance
with complementary legislation;
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d) Special authorization for access to associated traditional knowledge to a Brazilian
institution, public or private, that carries out research and development activities in
biological and related areas, and to a Brazilian university, public or private, for a period of
up to two years, renewable for equal periods, in accordance with complementary
legislation;
e) Accreditation of Brazilian public research and development institution or a federal
public management institution to authorize another Brazilian institution, public or
private, that carries out research and development activities in biological and related
areas:
1o To access samples of genetic heritage components and associated traditional
knowledge;
2o To ship samples of genetic heritage components to a Brazilian institution, public or
private, or to a foreign-based institution;
f) Accreditation of a Brazilian public institution to be the trustee of samples of genetic
heritage components;
V - Approving Contracts for Use of Genetic Heritage and Benefit-Sharing with regard to
their complying with the requirements of this Provisional Act and its complementary
legislation;
VI - Promoting debates and public hearings on the issues covered by this Provisional Act;
VII - Operating as the higher appeal body in regard to decisions of an accredited
institution and the acts arising from the enforcement of this Provisional Act;
VIII - Approving its bylaws.
Paragraph 1o The decisions of the Management Council are subject to appeal in the
plenary, in accordance with the complementary legislation.
Paragraph 2o The Management Council may be organized in thematic chambers to assist
plenary decisions.
Article 12. When the activity of collecting genetic heritage components and of accessing
associated traditional knowledge, which contributes to the progress of knowledge and
which is not associated to bioprospecting, involves the participation of a foreign legal
entity, shall be authorized by the body responsible for the Brazilian scientific and
technological research policy, in keeping with the terms of this Provisional Act and
legislation in force.
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Sole Paragraph. The authorization provided for in the chapeau of this article shall comply
with the technical standards defined by the Management Council, which shall oversee
these activities.
Article 13. The Chairperson of the Management Council is responsible for signing, on
behalf of the Federal Government, Contracts for Use of Genetic Heritage and BenefitSharing.
Paragraph 1o Within the mandate provided for in the chapeau of this article, the
Chairperson of the Management Council shall delegate to the head of a federal research
and development public institution, or a federal management institution, the competence
provided for in the chapeau of this article, in accordance with its respective area of action.
Paragraph 2o When the institution provided for in Paragraph 1o above is an interested
party in the contract, the contract shall be signed by the Chairperson of the Management
Council .
Article 14. The accredited institution provided for in numbers 1 and 2 of item "e" of
Paragraph IV of Article 11 of this Provisional Act, shall undertake one or more of the
following responsibilities, in compliance with the guidelines of the Management Council:
I - To analyze requests and issue, to third parties, authorization:
a) Accessing samples of genetic heritage components existing in in situ conditions, within
the Brazilian territory, on the continental shelf and in the exclusive economic zone, with
prior consent of its holders;
b) Accessing associated traditional knowledge, with the prior consent of its holders;
c) Shipping samples of genetic heritage components to a Brazilian institution, public or
private, or to a foreign-based institution;
II - To oversee, in coordination with federal entities, or by means of an agreement with
other institutions, the activities of access and shipment of samples of genetic heritage
components and access to associated traditional knowledge;
III - To create and maintain:
a) A register of ex situ collections, as provided for in Article 18 of this Provisional Act;
b) A database to record information obtained during the collection of samples of genetic
heritage components;
c) A database with information on the Authorizations of Access and Shipment, Material
Transfer Agreements and Contracts for Use of Genetic Heritage and Benefit-Sharing, in
accordance with complimentary legislation;
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IV - To disclose, periodically, a list of the Authorizations of Access and Shipment, Material
Transfer Agreements and Contracts for Use of Genetic Heritage and Benefit-Sharing;
V - To oversee the implementation of the Material Transfer Agreement and the Contracts
for Use of Genetic Heritage and Benefit-Sharing related to the cases it authorizes.
Paragraph 1o The accredited institution shall, every year, by means of a report, fully
inform the Management Council about the executed activities and send a copy of the
database to the executing unit provided for in Article 15.
Paragraph 2o The accredited institution, in the terms of Article 11, shall comply with the
provisions of this Provisional Act, its complementary legislation and the decisions of the
Management Council, under penalty of removal of its accreditation, and further subject to
the penalties provided for in Article 30 and legislation in force, as appropriate.
Article 15. The creation of an executing unit, to operate as the executive secretariat of the
Management Council provided for in Article 10 of this Provisional Act, is hereby
authorized, under the Ministry of Environment, with the following responsibilities,
among others:
I - Implementing the decisions of the Management Council;
II - Providing support to accredited institutions;
III - Issuing, in accordance with Management Council decisions, and on its behalf:
a) Authorization for Access and Shipment;
b) Special Authorization for Access and Shipment;
IV - Overseeing, in coordination with other federal bodies, the activities of access and
shipment of a sample of a genetic heritage component and access to associated traditional
knowledge;
V - Accrediting, in accordance with Management Council decision and on its behalf, a
Brazilian public research and development institution or a federal public administration
institution to authorize a Brazilian institution, public or private:
a) To access samples of genetic heritage components and associated traditional
knowledge;
b) To ship samples of genetic heritage components to a Brazilian institution, public or
private, or to a foreign institution, observing the requirements of Article 19 of this
Provisional Act;
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VI – Accrediting , in accordance with Management Council decision and on its behalf, a
Brazilian public institution to be the trustee of sample of genetic heritage components;
VII - Registering the Contracts for Use of Genetic Heritage and Benefit-Sharing, upon
Management Council consent;
VIII - Publishing a list of species with facilitated exchange contained in international
agreements, including on food safety, of which the country is signatory, in accordance
with Paragraph 2 of Article 19 of this Provisional Act;
IX - creating and maintaining:
a) Register of ex situ collections, as provided for in Article 18;
b) A database to record information obtained during the collection of samples of genetic
heritage components;
c) A database with information on the Authorizations of Access and Shipment, Material
Transfer Agreements and Contracts for Use of Genetic Heritage and Benefit-Sharing;
X - Disclosing, periodically, a list of the Authorizations of Access and Shipment, Material
Transfer Agreements and Contracts for Use of Genetic Heritage and Benefit-Sharing;
TITLE V
ACCESS AND SHIPMENT
Article 16. Access to genetic heritage components existing in in situ conditions, within the
Brazilian territory, on the continental shelf and in the exclusive economic zone, and to
associated traditional knowledge shall be take place by collecting samples and
information, respectively, and shall only be authorized to Brazilian, public or private,
institutions that carry out research and development in biological and related areas, in
accordance with this Provisional Act.
Paragraph 1oThe person responsible for a collection expedition shall, at the conclusion of
his activities in each accessed area, sign with the landowner, or his representative, a
declaration containing a list of the accessed material, in accordance with complementary
legislation.
Paragraph 2o Exceptionally, when the landowner or his representative is not identified or
found during the collection expedition, the declaration containing the list of the accessed
material shall be signed by the person responsible for the expedition and forwarded to the
Management Council.
Paragraph 3o A representative sub-sample of the accessed genetic heritage component
shall be deposited in ex situ condition at an institution accredited as trustee, as provided
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for in item "f" of Paragraph IV of Article 11 of this Provisional Act, in accordance with
complementary legislation.
Paragraph 4o When probability of commercial use is apparent, access to samples of a
genetic heritage components, in in situ conditions, and to the associated traditional
knowledge may only take place after signing a Contract for Use of Genetic Heritage and
Benefit-Sharing.
Paragraph 5o If potential for economic use is identified in a product or process, liable or
not to intellectual property protection, originating in a sample of a genetic heritage
component and in information arising from associated traditional knowledge, accessed
with authorization in which this hypothesis was not established, the authorized
institution commits itself to inform the Management Council or the institution where the
process for access and shipment originated, to formalize a Contract for Use of Genetic
Heritage and Benefit-Sharing.
Paragraph 6o Participation of a foreign legal entity in an expedition to collect in situ
samples of genetic heritage components and to access associated traditional knowledge
shall only be authorized when it is joined by a Brazilian public institution, the latter with
mandatory coordination of activities and if all participating institutions carry out research
and development activities in biological and related areas.
Paragraph 7o Research on genetic heritage components should preferably be carried out
on Brazilian territory.
Paragraph 8o Authorization for Access and Shipment of samples of genetic heritage
components of an endemic or an endangered species shall depend on the prior consent of
the competent body.
Paragraph 9o Authorization for Access and Shipment shall be given after prior consent of:
I - The indigenous community involved, after consulting the official Indian Affairs body,
when the access occurs in indigenous lands;
II - The competent body, when access occurs in protected area;
III - The owner of the private area, when the access occurs there;
IV - The National Defense Council, when the access takes place in an area essential for
national security;
V - The maritime authority, when the access takes place in Brazilian jurisdictional waters,
on the continental shelf and in the exclusive economic zone.
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Paragraph 10. The holder of the Authorization for Access and Shipment referred to in
items I to V of Paragraph 9 of this Article is responsible for compensating the owner of the
area for any incurred damage or harm, if duly proven.
Paragraph 11. The institution holding the Special Authorization for Access and Shipment
shall forward to the Management Council the consents referred to in Paragraphs 8 and 9
of this Article before or during the collection expeditions to be carried out during the
period in which the Authorization is in force, where non-compliance shall result in its
cancellation.
Article 17. In the instances of relevant public interest, so defined by the Management
Council, entrance into public or private area for access to samples of genetic heritage
components shall be done so without the prior consent of titleholders, assuring them that
provided for in Articles 24 and 25 of this Provisional Act.
Paragraph 1o In the instance provided for in the chapeau of this Article, the indigenous
community, the local community or the landowners shall receive prior notice.
Paragraph 2o If the area is in indigenous lands, the provisions of Paragraph 6 of Article
231 of the Federal Constitution must be observed.
Article 18. Ex situ conservation of samples of genetic heritage components is to be carried
out in Brazilian territory, and may also, in a complementary fashion, at the discretion of
the Management Council, be carried out abroad.
Paragraph 1o The ex situ collections of samples of genetic heritage components shall be
registered at the executing unit of the Management Council, in accordance with
complementary legislation.
Paragraph 2o The Management Council may delegate the registration referred to in
Paragraph 1 of this Article to one or more accredited institutions in the terms of items "d"
and "e" of Paragraph IV of Article 11 of this Provisional Act.
Article 19. Shipment of samples of genetic heritage components from a Brazilian
institution, public or private, to another Brazilian institution, public or private, shall be
carried out based on material in ex situ conditions, and on receipt of information on the
intended use, in cumulative compliance with the following conditions, in addition to
others that the Management Council may establish:
I - Deposit of a representative sub-sample of genetic heritage component in a collection
maintained by an accredited institution, should that provided for in Paragraph 3 of Article
16 of this Provisional Act not yet have been met;
II - In the instances when the samples of a genetic heritage components accessed in in situ
conditions before the enactment of this Provisional Act, the deposit referred to in the
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previous paragraph shall be carried out in the accessed form, if still available, in
accordance with complementary legislation;
III - Provide information obtained during the collection of samples of genetic heritage
components, for recording in the database mentioned in item "b" of Paragraph IX of
Article 15 of this Provisional Act;
IV - Prior signing of the Material Transfer Agreement.
Paragraph 1o Every time there is the probability of commercial use of the product or
process arising from a genetic heritage component is apparent, prior signing of a Contract
for Use of Genetic Heritage and Benefit-Sharing shall be required.
Paragraph 2o Shipment of samples of genetic heritage components of species that have
facilitated exchange in international agreements, including on food safety, of which Brazil
is signatory, shall be carried out according to the conditions defined therein, maintaining
the requirements of the items therein.
Paragraph 3o Shipment of any sample of genetic heritage component from a brazilian
institution, public or private, to a foreign-based institution, shall be carried out based on
material in ex situ conditions, and on receipt of information on the intended use and the
prior authorization of the Management Council or an accredited institution, observing the
cumulative compliance of the conditions established in items I to IV and Paragraphs 1 and
2 of this Article.
Article 20. The Material Transfer Agreement shall have its model approved by the
Management Council.
TITLE VI
ACCESS TO AND TRANSFER OF TECHNOLOGY
Article 21. The institution that receives samples of genetic heritage components or
associated traditional knowledge shall facilitate the access to and transfer of technology
for the conservation and use of this heritage or this knowledge, to the Brazilian institution
responsible for the access and shipment of the samples and information on the
knowledge, or to an institution it indicates.
Article 22. The access to and transfer of technology between a Brazilian research and
development institution, public or private, and a foreign-based institution, may be carried
out through the following activities, among others:
I – Scientific research and technological development;
II – Training and capacity building of human resources;
III – Exchange of information;
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IV - Exchange between a Brazilian research institution and a foreign-based research
institution;
V – Consolidation of scientific research and technological development infrastructure;
VI – Economic use, in partnership, of process and product arising from the use of a genetic
heritage component; and
VII – Establishment of joint technologically based undertaking.
Article 23. The company that, as it ensures the access to and transfer of technology to a
Brazilian institution, public or private, responsible for the access to and shipment of
samples of genetic heritage components and for the access to information on associated
traditional knowledge, invests in research and development in Brazil shall be able to
apply for fiscal incentives for technological capacity building of industry and agriculture
and for other incentive instruments, in accordance with the relevant legislation.
TITLE VII
BENEFIT- SHARING
Article 24. The benefits arising from the economic use of the product or process
developed from samples of genetic heritage components and associated traditional
knowledge, obtained by a Brazilian or foreign institution, shall be shared in a fair and
equitable manner among the contracting parties, as defined in complementary and
relevant legislation.
Sole Paragraph. When the Federal Government is not a party to the Contract for Use of
Genetic Heritage and Benefit-Sharing, it shall be assured participation in these benefits, as
provided for in the chapeau of this article, as appropriate, in accordance with
complementary legislation.
Article 25. The benefits arising from the economic use of the product or process
developed from a sample of a genetic heritage component or from associated traditional
knowledge, may be, among others:
I - Sharing of profits;
II - Payment of royalties;
III - Access and transfer of technologies;
IV – licensing, without cost, of products and processes; and
V – Capacity building of human resources;
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Article 26. The economic use of a product or process developed from samples of genetic
heritage components or from associated traditional knowledge, accessed in a manner
contrary to the provisions of this Provisional Act, shall subject the offender to payment of
compensation corresponding to at least twenty percent of the gross income obtained in
the commercialization of the product or of the royalties obtained from third parties by the
offender, as a result of licensing the product or process or use of technology, whether or
not they are protected by intellectual property, without prejudice to the administrative
sanctions and appropriate penalties.
Article 27. The Contract for Use of Genetic Heritage and Benefit-Sharing should clearly
indicate and qualify the contracting parties, namely, on the one side the owner of the
public or private area or the representative of the indigenous community and the official
Indian Affairs body, or the representative of the local community and, on the other side,
the Brazilian institution authorized to carry out the access and the recipient institution.
Article 28. The clauses that are mandatory in the Contract for Use of Genetic Heritage and
Benefit-Sharing, in accordance with complementary legislation, without prejudice to
others, are those that provide for:
I – The object, its elements, quantification of the sample and intended use;
II – Period of duration;
III – Manner of fair and equitable sharing of benefits, and when appropriate, access to and
transfer of technology;
IV – Rights and responsibilities of the parties;
V – Intellectual property rights;
VI – Withdrawal;
VII - Penalties;
VIII - Court jurisdiction in Brazil.
Sole Paragraph. When the Federal Government is a party, the contract mentioned in the
chapeau of this Article shall be ruled by the public law.
Article 29. The Contracts for Use of Genetic Heritage and Benefit-Sharing shall be
submitted for registration with the Management Council and shall only enter into force
after its consent.
Sole Paragraph. The Contracts for Use of Genetic Heritage and Benefit-Sharing shall be
considered null and void, without any legal standing, when they are signed contrary to
the provisions of this Provisional Act and its complementary legislation.
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TITLE VIII
ADMINISTRATIVE SANCTIONS
Article 30. An administrative violation against the genetic heritage or the associated
traditional knowledge is considered to be every act or omission that violates the rules
provided for in this Provisional Act and other relevant legal provisions.
Paragraph 1. The administrative violations shall be punished as provided for in the
complementary legislation of this Provisional Act, with the following sanctions:
I - Warning;
II – Fine;
III - Seizure of samples of the genetic heritage components and the instruments used in
the collection or processing or the products obtained as a result of information on
associated traditional knowledge;
IV - Seizure of all products derived from a sample of a genetic heritage component or of
associated traditional knowledge;
V - Suspension of the sale of the product derived from the sample of the genetic heritage
component or of the associated traditional knowledge and its seizure;
VI - Embargo of the activity;
VII - Partial or total closure of the business, activity or undertaking;
VIII – Suspension of the register, patent, license or authorization;
IX – Canceling of the register, patent, license or authorization;
X - Loss or reduction of fiscal incentives and benefits granted by the government;
XI - Loss or suspension of the right to receive financing from an official financing agency;
XII – Intervention in the establishment;
XIII – Prohibition of entering into contracts with the Public Administration for a period of
up to five years;
Paragraph 2. The samples, products and instruments referred to by items III, IV and V of
Paragraph 1 of this Article shall have their destination defined by the Management
Council.
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Paragraph 3. The sanctions established in this Article shall be applied in the procedural
manner established in the complementary legislation to this Provisional Act, without
prejudice to applicable civil or criminal sanctions.
Paragraph 4. The fines referred to by item II of Paragraph 1 of this Article shall be decided
by the competent authority according to the severity of the violation and pursuant to
complementary legislation, and can vary from R$200.00 (two hundred reals) to
R$100,000.00 (one hundred thousand reals), when an individual is involved.
Paragraph 5. If the violation is committed by a corporation, or with its abetment, the fine
shall be from R$10,000.00 (ten thousand reals) to R$50,000,000.00 (fifty million reals), to be
decided by the competent authority, according to the severity of the violation, pursuant to
the complementary legislation.
Paragraph 6. In the case of repeating incidence, the fine shall be doubled.
TITLE IX
FINAL PROVISIONS
Article 31. Granting of industrial property rights by the competent bodies over the
process or product obtained from samples of genetic heritage components is conditioned
to compliance with this Provisional Act. The person or institution applying for the
property rights must inform the origin of the genetic material and the associated
traditional knowledge, as appropriate.
Article 32. Competent federal bodies shall be responsible for supervision, interception and
seizing of samples of genetic heritage components or of product obtained from
information on associated traditional knowledge, accessed in manner contrary to the
provisions of this Provisional Act, pursuant to complementary legislation, and,
furthermore, said activities may be decentralized by means of agreements.
Article 33. The share of profits and royalties owed to the Federal Government, resulting
from the economic use of a process or products developed from samples of genetic
heritage components, as well as the fines and compensations dealt with by this
Provisional Act shall be intended for the National Environment Fund, created by Law No.
7797, dated July 10, 1989, and for the Navy Fund, created by Decree No. 20,923, dated
January 8, 1932, and for the National Scientific and Technological Development Fund,
created by Decree-Law No. 719, dated July 31, 1969 and reestablished by Law No. 8712,
dated January 18, 1991, pursuant to complementary legislation.
Sole Paragraph. The resources referred to by this Article shall be used exclusively in the
conservation of biological diversity, including the recovery, creation and maintenance of
depositary banks, in fostering scientific research, in the technological development
associated to genetic heritage and in the capacity building of human resources associated
to the development of activities related to the use and conservation of genetic heritage.
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Article 34. The person who uses or makes economic use of the components of genetic
heritage and associated traditional knowledge should make their activities compatible
with the provisions of this Provisional Act and its complementary legislation.
Article 35. The Federal Government shall enact complementary legislation to this
Provisional Act by December 30, 2001.
Article 36. The provisions of this Provisional Act do not apply to matter regulated by Law
No. 8974, dated January 5, 1995.
Article 37. The acts practiced in accordance with Provisional Act No 2,186-15, dated July
26, 2001 are hereby validated.
Article 38. This Provisional Act enters into force on the day of its publication.
Brasília, 23rd of August 2001; 180th Year of the Independence and 113th Year of the
Republic.
FERNANDO HENRIQUE CARDOSO
José Gregori
José Serra
Ronaldo Mota Sardenberg
José Sarney Filho
17
MINISTÉRIO DO MEIO AMBIENTE
CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO
ORIENTAÇÃO TÉCNICA Nº 1, DE 24 DE SETEMBRO DE 2003
Esclarece os conceitos de acesso e de remessa de
amostras de componentes do patrimônio genético
O CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO, no uso das
competências que lhe foram conferidas pela Medida Provisória nº 2.186-16, de 23 de agosto de
2001, e pelo Decreto nº 3.945, de 28 de setembro de 2001, e tendo em vista o disposto no art. 13,
inciso IV, de seu Regimento Interno,
Considerando a necessidade de se esclarecerem expressões cuja indeterminação vem
dificultando a exegese e aplicação da Medida Provisória nº 2.186-16, de 2001, resolve:
Art. 1º Para fins de aplicação do disposto no art. 7º, inciso IV, da Medida Provisória nº
2.186-16, de 23 de agosto de 2001, entende-se por “obtenção de amostra de componente do
patrimônio genético” a atividade realizada sobre o patrimônio genético com o objetivo de isolar,
identificar ou utilizar informação de origem genética ou moléculas e substâncias provenientes do
metabolismo dos seres vivos e de extratos obtidos destes organismos.
Art. 2º Para fins de aplicação do disposto na Medida Provisória no 2.186-16, de 2001, e
demais atos normativos dela decorrentes, entende-se por “remessa”:
I – a remessa propriamente dita: envio, permanente ou temporário, de amostra de
componente do patrimônio genético, com a finalidade de acesso para pesquisa científica,
bioprospecção ou desenvolvimento tecnológico, no qual a responsabilidade pela amostra transfirase da instituição remetente para a instituição destinatária;
II – o transporte: envio de amostra de componente do patrimônio genético com a
finalidade de acesso para pesquisa científica, bioprospecção ou desenvolvimento tecnológico, no
qual a responsabilidade pela amostra não se transfira da instituição remetente para a instituição
destinatária.
Art. 3º Esta Orientação Técnica entra em vigor na data de sua publicação.
JOÃO PAULO RIBEIRO CAPOBIANCO
Presidente do Conselho
Este texto não substitui o publicado no D.O.U. de 24.10.2004
MINISTÉRIO DO MEIO AMBIENTE
CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO
ORIENTAÇÃO TÉCNICA Nº 2, DE 30 DE OUTUBRO DE 2003
O CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO, no uso das
competências que lhe foram conferidas pela Medida Provisória nº 2.186-16, de 23 de agosto de
2001, e pelo Decreto nº 3.945, de 28 de setembro de 2001, e tendo em vista o disposto no art. 13,
inciso IV, de seu Regimento Interno, resolve:
Art. 1º Para fins de aplicação do disposto no art. 16, § 3º, da Medida Provisória nº
2.186-16, de 23 de agosto de 2001, considera-se “sub-amostra representativa de cada população
componente do patrimônio genético acessada” porção de material biológico ou de componente do
patrimônio genético, devidamente acompanhada de informações biológicas, químicas ou
documentais que permitam a identificação da procedência e a identificação taxonômica do material.
Art. 2º Esta Orientação Técnica entra em vigor na data de sua publicação.
JOÃO PAULO RIBEIRO CAPOBIANCO
Presidente do Conselho
Este texto não substitui o publicado no D.O.U. de 15.01.2004
MINISTÉRIO DO MEIO AMBIENTE
CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO
ORIENTAÇÃO TÉCNICA Nº 3, DE 18 DEZEMBRO DE 2003
O CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO, no uso das
competências que lhe foram conferidas pela Medida Provisória nº 2.186-16, de 23 de agosto de
2001, e pelo Decreto nº 3.945, de 28 de setembro de 2001, e tendo em vista o disposto no art. 13,
inciso IV, de seu Regimento Interno, resolve:
Art. 1º Para fins de aplicação do disposto no art. 12 da Medida Provisória nº 2.186-16,
de 23 de agosto de 2001, considera-se como atividade sujeita à autorização do órgão responsável
pela política nacional de pesquisa científica e tecnológica a participação de pessoa jurídica
estrangeira em atividades de coleta ou acesso a componentes do patrimônio genético ou a
conhecimento tradicional associado, realizadas no território nacional, que contribuam para o avanço
do conhecimento e não estejam associadas à bioprospecção.
Art. 2º Esta Orientação Técnica entra em vigor na data de sua publicação.
JOÃO PAULO RIBEIRO CAPOBIANCO
Presidente do Conselho
Este texto não substitui o publicado no D.O.U. de 15.01.2004
MINISTÉRIO DO MEIO AMBIENTE
CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO
ORIENTAÇÃO TÉCNICA Nº 4, DE 27 DE MAIO DE 2004
Esclarece o significado da expressão “desenvolvimento
tecnológico”
O CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO, no uso das
competências que lhe foram conferidas pela Medida Provisória nº 2.186-16, de 23 de agosto de
2001, e pelo Decreto nº 3.945, de 28 de setembro de 2001, e tendo em vista o disposto no art. 13,
inciso IV, de seu Regimento Interno,
Considerando a necessidade de esclarecer expressão cuja indeterminação vem
dificultando a exegese e aplicação da Medida Provisória nº 2.186-16, de 23 de agosto de 2001;
Considerando que o acesso a componente do patrimônio genético e aos conhecimentos
tradicionais associados para fins de desenvolvimento tecnológico depende de autorização do
Conselho, resolve:
Art. 1º Para fins de aplicação do disposto na Medida Provisória nº 2.186-16, de 23 de
agosto de 2001, entende-se por “desenvolvimento tecnológico” o trabalho sistemático, decorrente
do conhecimento existente, que visa à produção de inovações específicas, à elaboração ou à
modificação de produtos ou processos existentes, com aplicação econômica.
Art. 2º Esta Orientação Técnica entra em vigor na data de sua publicação.
JOÃO PAULO RIBEIRO CAPOBIANCO
Presidente do Conselho
Este texto não substitui o publicado no D.O.U. de 17.06.2004
MINISTÉRIO DO MEIO AMBIENTE
CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO
ORIENTAÇÃO TÉCNICA Nº 6, DE 28 DE AGOSTO DE 2008
Esclarece o conceito de "potencial de uso comercial"
para finalidade de acesso a componente do patrimônio
genético.
O CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO, no uso das competências
que lhe foram conferidas pela Medida Provisória nº 2.186-16, de 23 de agosto de 2001, e pelo
Decreto nº 3.945, de 28 de setembro de 2001, e tendo em vista o disposto no art. 13, inciso IV, de
seu Regimento Interno,
considerando a necessidade de se esclarecerem expressões cuja indeterminação vem
dificultando a exegese e aplicação da Medida Provisória nº 2.186-16, de 2001, resolve:
Art. 1º Para fins de aplicação do disposto no art. 7º, inciso VII, da Medida Provisória nº
2.186-16, de 23 de agosto de 2001, considera-se identificado o "potencial de uso comercial" de
determinado componente do patrimônio genético no momento em que a atividade exploratória
confirme a viabilidade de produção industrial ou comercial de um produto ou processo a partir de
um atributo funcional desse componente.
Art. 2º Esta Orientação Técnica entra em vigor na data de sua publicação.
MARIA CECÍLIA WEY DE BRITO
Presidente do Conselho
Este texto não substitui o publicado no D.O.U. de 29.09.2008
MINISTÉRIO DO MEIO AMBIENTE
CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO
ORIENTAÇÃO TÉCNICA Nº 7, DE 30 DE JULHO DE 2009
Esclarece os conceitos de pesquisa científica,
bioprospecção e desenvolvimento tecnológico para a
finalidade de melhoramento genético vegetal
O CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO, no uso das competências que lhe foram
conferidas pela Medida Provisória no 2.186-16, de 23 de agosto de 2001, e pelo Decreto no 3.945, de 28 de
setembro de 2001, e tendo em vista o disposto no art. 13, inciso IV, de seu Regimento Interno; e,
Considerando que nas atividades relacionadas ao melhoramento genético vegetal incluem-se projetos
com distintas naturezas, objetivos e metodologias;
Considerando que esses projetos, de acordo com suas características, podem ser classificados como
tendo a finalidade de pesquisa científica, bioprospecção ou desenvolvimento tecnológico;
Considerando que os projetos que envolvam perspectivas de melhoramento genético vegetal não
necessariamente equivalem a projetos de desenvolvimento tecnológico de novos cultivares; e
Considerando a necessidade de se estabelecer critérios objetivos para delimitar a finalidade dos
diferentes tipos de acesso para melhoramento genético vegetal, resolve:
Art. 1º Para fins de avaliação dos pedidos de autorização de acesso no âmbito de projetos que tenham
por finalidade o melhoramento genético vegetal, submetidos ao Conselho de Gestão do Patrimônio Genético,
nos termos da Medida Provisória no 2.186, de 23 de agosto de 2001, entende-se por:
I - Pesquisa científica: conjunto de atividades visando a seleção de genótipos promissores para início
das atividades de bioprospecção;
II - Bioprospecção: etapa na qual os genótipos promissores, selecionados na fase da pesquisa
científica, são submetidos a testes de Distinguibilidade, Homogeneidade e Estabilidade-DHE e de Valor de
Cultivo e Uso-VCU, ou ensaios equivalentes; e
III - Desenvolvimento tecnológico: etapa final do programa de melhoramento envolvendo a obtenção
de sementes genéticas ou plantas básicas, no caso de espécies de propagação vegetativa.
Parágrafo único. O uso de amostras provenientes de áreas privadas que, por ocasião da coleta, não
tenham sido consideradas como ocupadas por comunidades locais e, no decorrer das atividades, sejam
identificadas como tais, fica condicionado à adequação dos procedimentos, de acordo com as definições
desta Orientação Técnica.
Art. 2º Esta Orientação Técnica entra em vigor na data de sua publicação.
Art. 3º Fica Revogada a Orientação Técnica no 05, de 15 de dezembro de 2005, publicada o Diário
Oficial da União de 21 de dezembro de 2005, Seção 1, página 98.
MARIA CECÍLIA WEY DE BRITO
Presidente do Conselho
Este texto não substitui o publicado no D.O.U. De 21.10.2009
MINISTÉRIO DO MEIO AMBIENTE
CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO
RESOLUÇÃO No 21, DE 31 DE AGOSTO DE 2006
O CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO, tendo em vista as
competências que lhe foram conferidas pela Medida Provisória no 2.186-16, de 23 de agosto de 2001, e
pelo Decreto no 3.945, de 28 de setembro de 2001, e o disposto no art. 13, inciso I, do seu Regimento
Interno;
Considerando que diversos tipos de pesquisas e atividades científicas poderiam enquadrarse sob o conceito de acesso ao patrimônio genético para fins de pesquisa científica simplesmente pelo fato
de utilizarem ferramentas metodológicas moleculares para a sua execução de modo circunstancial e não
propriamente porque seus objetivos ou perspectivas estejam relacionados com o acesso ao patrimônio
genético;
Considerando que a finalidade dessas pesquisas e atividades, assim como seus resultados e
aplicações, não interferem no principal objetivo da Medida Provisória no 2.186-16, de 2001, que é a
garantia da repartição justa e eqüitativa dos benefícios resultantes da exploração econômica de produto ou
processo desenvolvido a partir de amostras de componentes do patrimônio genético, resolve:
Art. 1o As seguintes pesquisas e atividades científicas não se enquadram sob o conceito de
acesso ao patrimônio genético para as finalidades da Medida Provisória no 2.186-16, de 23 de agosto de
2001:
I - as pesquisas que visem avaliar ou elucidar a história evolutiva de uma espécie ou de
grupo taxonômico, as relações dos seres vivos entre si ou com o meio ambiente, ou a diversidade
genética de populações; (redação alterada pela Resolução n. 28, de 6 de novembro de 2007)
II - os testes de filiação, técnicas de sexagem e análises de cariótipo ou de ADN que visem
à identificação de uma espécie ou espécime; (redação alterada pela Resolução n. 28, de 6 de novembro
de 2007)
III - as pesquisas epidemiológicas ou aquelas que visem a identificação de agentes
etiológicos de doenças, assim como a medição da concentração de substâncias conhecidas cujas
quantidades, no organismo, indiquem doença ou estado fisiológico;
IV - as pesquisas que visem a formação de coleções de ADN, tecidos, germoplasma,
sangue ou soro.
§ 1o As pesquisas e atividades científicas mencionadas neste artigo estão dispensadas da
obtenção de autorização de acesso a componente do patrimônio genético.
§ 2o O critério estabelecido nesta Resolução tem a finalidade exclusiva de orientar o
enquadramento destas atividades sob a Medida Provisória no 2.186-16, de 2001, sem prejuízo do
atendimento das exigências estabelecidas em outros instrumentos legais, bem como em tratados
internacionais dos quais o Brasil seja Parte.
§ 3º As autorizações de acesso que se refiram às pesquisas e atividades científicas
mencionadas no caput deste artigo e seus incisos, concedidas em data anterior à publicação da
Resolução nº 21, de 31 de agosto de 2006, perdem sua validade no que diz respeito a essas pesquisas e
atividades. (parágrafo incluído pela Resolução n. 28, de 6 de novembro de 2007)
§ 4º Quando se tratar de autorização especial, consideram-se excluídas do portfólio
correspondente às pesquisas e atividades científicas mencionadas no caput deste artigo e seus incisos,
continuando a autorização válida para as demais pesquisas e atividades integrantes do portfólio.
(parágrafo incluído pela Resolução n. 28, de 6 de novembro de 2007)
Art. 2o Esta Resolução entra em vigor na data de sua publicação.
MARINA SILVA
Ministra de Estado do Meio Ambiente
MINISTÉRIO DO MEIO AMBIENTE
CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO
RESOLUÇÃO Nº 26, DE 30 DE AGOSTO DE 2007
As variedades cultivadas comerciais de cana-de-açúcar,
Saccharum spp., inscritas no Registro Nacional de
Cultivares - RNC, do Ministério da Agricultura, Pecuária e
Abastecimento, não se caracterizam como patrimônio
genético do País para as finalidades da Medida Provisória
nº 2.186-16, de 23 de agosto de 2001.
O CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO, tendo em vista as competências que
lhe foram conferidas pela Medida Provisória nº 2.186-16, de 23 de agosto de 2001, e pelo Decreto nº 3.945,
de 28 de setembro de 2001, e o disposto no art. 13, inciso I, do seu Regimento Interno, resolve:
Art. 1º As variedades cultivadas comerciais de cana-de-açúcar, Saccharum spp., inscritas no Registro
Nacional de Cultivares - RNC, do Ministério da Agricultura, Pecuária e Abastecimento, não se caracterizam
como patrimônio genético do País para as finalidades da Medida Provisória nº 2.186-16, de 23 de agosto de
2001.
§ 1º O acesso ao patrimônio genético das variedades mencionadas neste artigo não requer a
autorização de acesso prevista na Medida Provisória nº 2.186-16, de 2001.
§ 2º O critério estabelecido nesta Resolução tem a finalidade exclusiva de orientar o enquadramento
das referidas variedades sob a Medida Provisória nº 2.186-16, de 2001, sem prejuízo do atendimento às
exigências estabelecidas em outros instrumentos legais, bem como em tratados internacionais dos quais o
Brasil seja Parte.
Art. 2º Esta Resolução entra em vigor na data de sua publicação.
MARINA SILVA
Ministra de Estado do Meio Ambiente
MINISTÉRIO DO MEIO AMBIENTE
CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO
D809163-0>
RESOLUÇÃO Nº 29, DE 6 DE DEZEMBRO DE 2007
Dispõe sobre o enquadramento de óleos fixos, óleos
essenciais e extratos no âmbito da Medida Provisória nº
2.186-16, de 23 de agosto de 2001.
O CONSELHO DE GESTÃO DO PATRIMÔNIO GENÉTICO, no uso das competências que
lhe foram conferidas pela Medida Provisória nº 2.186-16, de 23 de agosto de 2001, e pelo Decreto no 3.945,
de 28 de setembro de 2001, e tendo em vista o disposto no art. 13, inciso I, de seu Regimento Interno, e
Considerando que a elaboração de óleos fixos, essenciais e de extratos comerciais, embora envolva atividades
de isolamento de componentes do patrimônio genético, em determinados contextos não caracteriza o acesso
ao patrimônio genético, resolve:
Art. 1º Para fins de aplicação do disposto na Medida Provisória nº 2.186-16, de 23 de agosto
de 2001, não se enquadra no conceito de acesso ao patrimônio genético a elaboração de óleos fixos, de óleos
essenciais ou de extratos quando esses resultarem de isolamento, extração ou purificação, nos quais as
características do produto final sejam substancialmente equivalentes à matéria prima original.
Parágrafo único. Os órgãos competentes do Poder Público poderão solicitar, a qualquer
momento, às instituições que desenvolvam as atividades tratadas nesta Resolução, a documentação que
comprove o enquadramento no caput deste artigo.
Art. 2º Esta Resolução entra em vigor na data de sua publicação.
MARINA SILVA
Ministra de Estado do Meio Ambiente