This following translation was furnished by Translation Service of the Secretariat of Information and Documentation within Brazil's Federal Senate. 
Translated from Portuguese by Vanira Tavares.

BRAZIL'S BILL ON "ACCESS TO GENETIC RESOURCES"

BILL OF LAW Nš 306/95

Emended version presented by Rapporteur Senator Osmar Dias (PSDB/PR),

as approved by the Commission on Social Affairs of the Federal Senate of Brazil,

on November 19, 1997

Provides for the access to genetic resources and their derived products and makes other provisions.

 

THE NATIONAL CONGRESS decrees:

TITLE I

PRELIMINARY PROVISIONS

Article 1. This Act provides for rights and duties concerning the

access to genetic resources, genetic material, and derived products, in ex

situ or in situ conditions, existing in the Brazilian territory or having

Brazil as their country of origin, to traditional knowledge possessed by

indigenous populations and local communities, associated with genetic

resources or derived products and with domesticated and semi-domesticated

crops in Brazil.

Article 2. Genetic resources and derived products are considered

public property of special use of the Brazilian Nation, and the contracts

of access to them shall be carried out under the terms of this Act, without

prejudice to material and immaterial property rights relating to:

I - the natural resources containing the genetic resource or

derived product;

II - the lands traditionally inhabited by Indians and their

exclusive enjoyment of the riches existing in such lands;

III - the private collection of genetic resources or derived products;

IV - the traditional knowledge possessed by indigenous populations

and local communities, associated with genetic resources or derived

products;

V - the domesticated and semi-domesticated crops in Brazil.

Sole paragraph. The owners and holders of goods and rights referred

to in this article shall be ensured of the fair and equitable sharing of

the benefits derived from the access to genetic resources, to the

traditional knowledge possessed by indigenous populations and local

communities associated with genetic resources and derived products, and to

the domesticated and semi-domesticated crops in Brazil, under the terms of

this Act.

Article 3. The legal classification presented in the previous

article does not apply to the genetic resources and any components or

substances of human beings, with due regard to the provisions of article 8

of this Act.

 

TITLE II

DEFINITION OF TERMS AND GENERAL PROVISIONS

Chapter I

Definition of Terms

Article 4. For the purposes of this Act, the following definitions

apply:

ACCESS TO GENETIC RESOURCES: acquisition and utilization of genetic

resources, genetic material and derived products, in ex situ or in situ

conditions, existing in the Brazilian territory or having Brazil as their

country of origin, of knowledge possessed by indigenous populations and

local communities associated with genetic resources or derived products,

and of domesticated and semi-domesticated crops in Brazil, for purposes of

research, bioprospecting, conservation, industrial application or

commercial exploitation, among others.

COMPETENT AUTHORITY: public agency appointed by the Government to enter

into contracts regarding the access to genetic resources, which must

include benefit sharing and the access to and the transfer of technology,

as set forth in this Act.

BIOTECHNOLOGY: any technological application which uses biological systems

or living organisms, part of them or their derived products, to make or

modify products or processes for specific utilization.

EX SITU CONSERVATION CENTER: institution recognized by the competent

authority, which collects and conserves the components of biological

diversity out of their natural habitats.

TRADITIONAL KNOWLEDGE: any knowledge, innovation, or individual or

collective practice of an indigenous population or local community, having

real or potential value, associated with a genetic resource or derived

product, protected or not by intellectual property legislation.

LOCAL COMMUNITY AND INDIGENOUS POPULATION: human group differentiated by

its social, cultural and economic conditions, organized, in total or in

part, according to its own customs and traditions or by special

legislation, and preserving, whatever juridical status it has, its own

social, economic, and cultural institutions, or part of them.

EX SITU CONDITIONS: conditions in which the components of biological

diversity are conserved out of their natural habitats.

IN SITU CONDITIONS: conditions in which genetic resources exist in

ecosystems and natural habitats, and, in the case of domesticated and

cultivated species, in the environments where they have developed their

characteristic properties.

CONTRACT OF ACCESS: agreement between the competent authority and

individuals or corporate bodies, establishing the terms and conditions for

their access to genetic resources and their subsequent utilization, which

must include benefit sharing and the access to and the transfer of

technology, as set forth in this Act.

BIOLOGICAL DIVERSITY: variability of living organisms of all origins,

comprising land and marine ecosystems and other water ecosystems, and the

ecological complexes they integrate, as well as genetic diversity, the

diversity of species and of ecosystems.

GENETIC DIVERSITY: variability of genes and of genotypes among and in

species; part or the whole of the genetic information contained in

biological resources.

ECOSYSTEM: a dynamic complex of plant, animal and microorganism

communities, and their inorganic environment, which interact as a

functional unit.

GENETIC EROSION: loss or reduction of genetic diversity, due to anthropic

action or natural causes.

GENETIC MATERIAL: any biological material of plant, animal, microbial or

other origin, which contains functional units of heredity.

COUNTRY OF ORIGIN OF GENETIC RESOURCES: country which possesses these

genetic resources in in situ conditions, including those which, having been

in such conditions, are now in ex situ conditions under Brazilian

jurisdiction.

DERIVED PRODUCT: isolated natural product of biological origin, or

structurally based on it, or having been in some way created from the

utilization of a traditional knowledge associated with it.

PROVIDER OF TRADITIONAL KNOWLEDGE: community or group empowered, under the

terms of this Act and by means of the contract of access, to take part in

the decision-making process regarding the provision of the traditional

knowledge it possesses.

PROVIDER OF GENETIC RESOURCE: individual or corporate body, indigenous

population or local community, empowered, under the terms of this Act and

by means of the contract of access, to take part in the decision-making

process regarding the provision of a genetic resource, genetic material, or

their derived products.

BIOLOGICAL RESOURCES: organisms or parts of them, populations or any other

biotic component of ecosystems, comprising genetic resources.

GENETIC RESOURCES: genetic material of actual or potential value, including

the genetic variability of species of plants, animals and microorganisms

which make up biological diversity, of present or potential social and

economic interest, for immediate utilization or genetic improvement, in

biotechnology, in other sciences or in related undertakings.

BENEFIT SHARING: comprises measures to promote and ensure the distribution

of outcomes, either economic or not, of research, development,

commercialization or licensing derived from the access to genetic

resources, including the access, transfer of technology and biotechnology,

and the participation in research and development activities related to

genetic resources.

SUSTAINABLE USE: utilization of components of biological diversity in such

a manner and in such a pace so as not to bring about the long-term

reduction of biological diversity, thus preserving its potential to meet

the needs and aspirations of the present and future generations.

 

Chapter II

General Provisions

Article 5. It is incumbent upon every individual and corporate

body, and upon the State, in particular, to preserve the genetic patrimony

and the biological diversity of the Country, to promote their study and

sustainable use and to control the activities of access to genetic

resources, as well as to oversee the institutions engaged in prospecting,

collection, research, conservation, manipulation, commercialization, among

other activities related to such resources, under the terms of this Act,

with due regard to the following principles:

I - integrity of the genetic patrimony and of the biological

diversity of the Country;

II - national sovereignty over the genetic resources and their

derived products, existing in the Brazilian territory;

III - need of justified prior consent of the local communities and

indigenous populations for the activities of access to the genetic

resources located in the areas they inhabit, to their domesticated and

semi-domesticated crops, and to the traditional knowledge they possess;

IV - intellectual integrity of the traditional knowledge possessed

by the local community or indigenous population, it being ensured the

recognition, protection, fair and equitable compensation for its

utilization, and freedom of exchange among their members and with other

similar communities and populations;

V - inalienability, restraint of mortgage, and imprescriptibility

of rights relating to the traditional knowledge possessed by the local

community or indigenous population and to their domesticated and

semi-domesticated crops, their utilization being possible, however, with

justified prior consent of the respective local community or indigenous

population, and by means of fair and equitable compensation, under the

terms of this Act;

VI - national participation in the economic and social benefits

arising from the activities of access, especially for the benefit of the

sustainable development of the areas allowing access to genetic resources

and of the local communities and indigenous populations providing

traditional knowledge;

VII - priority of implementation in the Brazilian territory to the

processing, research and development related to the genetic resources to

which access was granted;

VIII - promotion of and support for the various forms of

generation, to the benefit of the Country, of knowledge and technologies

related to genetic resources and derived products;

IX - protection and encouragement of cultural diversity,

highlighting the knowledge, innovations and practices of the local

communities and indigenous populations related to the conservation,

improvement, use, management, and exploitation of genetic resources and

their derived products;

X - compatibility with policies, principles and rules related to

biosafety;

XI - compatibility with policies, principles and rules related to

food safety of the Country;

XII - compatibility with policies, principles and rules related to

the national policies of environmental protection;

XIII - compliance with and strengthening of the Convention on

Biological Diversity and other international agreements regarding the

conservation and sustainable use of biodiversity.

Article 6. The contracts of access to genetic resources, their

control and oversight are aimed at the conservation, study and sustainable

use of the biological diversity of the Country, the provisions of this Act

being applied to all individuals or corporate bodies, either Brazilian or

foreign, as well as to:

I - any activity of extraction, use, exploitation, storing or

commercialization, in the Brazilian territory, of genetic resources or

their derived products; and,

II - any agreement or contract, public or private, regarding

genetic resources and derived products originating in the Country.

Article 7. This Act applies to the inland, coastal, marine and

island genetic resources and their derived products existing in the

Brazilian territory or having Brazil as their country of origin, as well as

to the associated traditional knowledge possessed by local communities and

indigenous populations, and to the migrating species which, for natural

causes, are present in the Brazilian territory.

Article 8. This Act does not apply:

I - to the genetic materials and any components or substances of

human beings, with any collection or use of these resources, components or

substances being subject to approval by the Executive Power, upon justified

prior consent of the individual concerned, while a specific act regulating

the matter does not come into force;

II - to the exchange of genetic resources, derived products,

traditional crops or associated traditional knowledge, carried out by the

local communities and indigenous populations, among themselves, for their

own purposes and based on their customary practices;

Article 9. The use, either direct or indirect, of biological

resources, genetic resources, or genetic materials and derived products in

biological weapons or in practices which are harmful to the environment or

to human health is forbidden.

 

TITLE III

INSTITUTIONAL DUTIES

Article 10. To ensure compliance with the provisions of this Act,

the Federal Government shall appoint an agency of the Direct Administration

to carry out the functions of competent authority and to be responsible for

authorizing access to genetic resources.

Article 11. The decisions of the competent authority with respect

to the national policy of access and to the authorizations of access shall

be signed by a Genetic Resources Committee, to be established by the

Executive Power, made up of representatives of the Federal Government, the

state governments and the Federal District, the scientific community, the

local communities and indigenous populations, the agencies of access, the

non-governmental organizations and private companies, with parity of

representation of members of the Government and of the communities and

non-governmental institutions, the institutions of education and research

being included among the latter.

Sole paragraph. The competent authority shall carry out the

functions of executive secretariat of the Genetic Resources Committee,

according to the regulations.

Article 12. In addition to signing contracts of access, it is

incumbent upon the competent authority, upon opinion of the Genetic

Resources Committee and with due regard to the provisions of this Act and

of any other legislation and environmental policy tools:

I - to prepare, coordinate and carry out the national policy of

access to genetic resources, with a view to preserving the diversity and

integrity of the national genetic patrimony;

II - to oversee, control and assess the activities of access to

genetic resources developed in the Country;

III - to support the issuing and updating of periodical reports

about the degrees of threat to the national biodiversity and about the

actual and potential impacts on its preservation;

IV - to cooperate with agencies of the Executive Power,

international organizations, local communities and non-governmental

organizations in the preparation of lists of biological resources

threatened of extinction or of deterioration, and of areas in danger of

serious loss of biodiversity, as well as in the definition of the necessary

mechanisms of control;

V - to contribute to the disclosure of information regarding

threats to the national biological diversity;

VI - to monitor and promote researches and inventories of the

national biological diversity and develop mechanisms to organize and

maintain this information;

VII - to contribute to the development of activities of ex situ

conservation of genetic resources;

VIII - to identify priorities and promote the training of the

personnel necessary to the activities of access, as well as to propose

training programs.

Article 13. At any time, in case of danger of serious and

irreparable damage deriving from activities carried out under the terms of

this Act, the Government, based on a technical opinion and on

proportionality criteria, shall adopt measures to prevent such damage and

may even stop the activity, especially in the following cases:

I - endangered species, subspecies, lineages or varieties;

II - reasons of endemism or rarity;

III - vulnerable conditions of the structure or functioning of

ecosystems;

IV - adverse effects on human health or on the quality of life or

cultural identity of the local communities and indigenous populations;

V - environmental impacts which are undesirable or difficult to

control, upon urban and rural ecosystems;

VI - danger of genetic erosion or loss of ecosystems, of their

resources or components, because of undue or uncontrolled collection of

germplasm;

VII - non-compliance with biosafety or food safety rules and

principles; and

VIII - use of resources for purposes contrary to national interests

and to the agreements entered into by the Country.

Sole paragraph. The lack of absolute scientific certainty regarding

the cause and effect relationship between the activity of access to genetic

resources and the damage may not be presented as a reason to disregard the

adoption of the necessary effective measures.

 

TITLE IV

ACCESS TO GENETIC RESOURCES

Chapter I

Access to Resources in In situ Conditions

Article 14. Any procedure of access to genetic resources in the

Brazilian territory, in in situ conditions, shall be subject to prior

authorization of the competent authority and to the signing and publication

of a contract between the competent authority and the individuals and

corporate bodies concerned.

Sole paragraph. The competent authority shall keep a reference file

of public institutions and non-profit private organizations which carry out

activities related to the conservation and sustainable use of natural

resources, referred to as "agencies of access" for the purposes of this

Act, empowered to request access on behalf of third parties, discuss

additional contracts and clauses for the protection of rights relating to

traditional knowledge, and manage projects and investment of funds derived

from contracts of access.

 

Section I

The Petition and the Project of Access

Article 15. To obtain authorization and sign a contract of access

to a genetic resource, the petitioner or the agency of access must present

a petition, together with the project of access, including at least the

following items:

I - curriculum vitae and complete identification, including those

of the respective responsible persons:

a) of the petitioner of access, either an individual or a corporate

body who will implement the access, and who must have both the legal

capacity to sign a contract and proven technical capacity, including

information about all the persons or institutions who will be involved in

the procedures of access;

b) of the agency of access, including the file registration and the

contract with the petitioner of access, as the case may be;

c) of the holder of the natural resource containing the genetic

resource, or of the collection of genetic resources, as the case may be;

d) of the provider of traditional knowledge;

e) the name of the public institution of education, of research or

of public interest domiciled in Brazil, in charge of monitoring the

procedures of access.

II - complete information on the timetable, budget and sources of

financing for the activities scheduled;

III - detailed and specified description of the genetic resources,

derived products or traditional knowledge to which access is intended,

including their current and potential uses, their environmental

sustainability, and the risks which may arise from such access;

IV - detailed description of the methods, techniques, collection

systems and tools to be used;

V - precise location of the areas where the procedures of access

will be carried out;

VI -indication of the destination of the material collected and of

its probable future use.

Paragraph 1. In the case of access to traditional knowledge, the

project referred to in this article shall include an authorization to visit

the local community or indigenous population, as well as the information

collected, from an oral or a written source, related to the traditional

knowledge concerned.

Paragraph 2. The competent authority shall also, when it deems

necessary, require the presentation of an environmental impact study and

report related to the activities to be carried out.

Article 16. If the petition and project of access are considered

complete, the competent authority will grant it a date, hour and number of

registration and, within 15 (fifteen) days as of such date, it will take

the following steps:

I - publication of an abstract of the petition and of the project

of access in the Federal Official Gazette;

II - publication of an abstract of the petition and of the project

of access, for 3 (three) consecutive days, in the newspaper of highest

circulation figures in the region where the access will take place;

III - when the institution assigned by the petitioner or by the

agency of access is not approved, indication of at least three institutions

which may be assigned to monitor the procedures of access under the terms

of this Act.

Sole paragraph. If the petition and the project of access are

deemed incomplete, they may not be accepted by the competent authority, who

shall immediately return them for correction.

Article 17. Within 60 (sixty) days as of the publication of the

petition and project of access, the competent authority shall start its

examination, analyzing the information provided according to article 15,

carrying out the necessary inspections, and, based upon a

technical-juridical opinion and upon the opinions expressed by any

interested party, submitted within the legal time period, it shall make a

decision whether to accept the petition or not.

Paragraph 1. The deadline stipulated in the caption may be

extended, at the discretion of the competent authority.

Paragraph 2. The petitions of access to take place in conservation

units shall be subject to an opinion of the competent agencies, to be

issued without prejudice to the deadline stipulated in the caption.

Paragraph 3. The petitions of access to take place in indigenous

areas shall be subject to an opinion of the competent agencies, to be

issued without prejudice to the deadline stipulated in the caption, as well

as to the justified prior consent of the indigenous community concerned,

under the terms of this Act.

Article 18. Before the end of the time period for examination, the

competent authority, based on the opinion provided for in the previous

article, shall grant or dismiss the petition by means of a justified

decision.

Paragraph 1. The decision to dismiss shall be communicated to the

interested party and shall be the final step of the procedures, without

prejudice to the admissible administrative or judicial appeals.

Paragraph 2. The decision to grant the petition shall be

communicated to the interested party within 10 (ten) days and published in

the Official Gazette and in the newspaper of highest circulation figures in

the region where the access will take place, being followed by the

discussion and preparation of the contract of access.

 

 

Section II

The Contract of Access

Article 19. The following are the parties to the contract of access:

a) the State, represented by the competent authority;

b) the petitioner of access;

c) the agency of access;

d) the provider of traditional knowledge or domesticated crop, in

the case of contracts of access involving such components.

Article 20. When the petition of access involves a traditional

knowledge or domesticated crop, the contract of access shall include, as an

integral part, an annex referred to as a supplementary contract on the

utilization of traditional knowledge or domesticated crop, undersigned by

the competent authority, by the provider of traditional knowledge or

domesticated crop, by the petitioner and the agency of access, as the case

may be, stipulating a fair and equitable compensation with respect to the

benefits arising from such utilization, the form of such participation

being expressly indicated.

Article 21. During the stage of discussion of the contract of

access, the petitioner or agency of access shall submit to the competent

authority the additional contracts they may have entered into with third

parties, under the terms of this Act.

Paragraph 1. The public or private institution operating as

national support, under an additional contract set forth in this Act, shall

be accepted by the competent authority.

Paragraph 2. The acceptance set forth in the previous paragraph

shall not, by any means, render the competent authority responsible for

compliance with the respective additional contract.

Article 22. The contract of access, as determined by the terms and

clauses mutually agreed upon by the parties, shall include, in addition to

the information provided by the petitioner or the agency of access, all of

the conditions and duties to be fulfilled, as follows:

I - definition of the object of the contract, as registered in the

petition and project of access;

II - determination of the holders of possible intellectual property

rights and the commercialization of products and processes obtained, as

well as of the conditions for the granting of licenses;

III - obligation of the petitioner and of the agency of access not

to forego or transfer to third parties the access, management or

utilization of genetic resources and their derived products without the

express consent of the competent authority, and, as the case may be, of the

local communities or indigenous populations who possess the traditional

knowledge or domesticated crop, subject to a procedure of access;

IV - commitment of the petitioner and of the agency of access to

give prior notice to the competent authority about the researches and

utilization of the genetic resources and derived products subject to access;

V - commitment of the petitioner and of the agency of access to

submit to the competent authority the reports and other publications

prepared about the genetic resources and derived products subject to access;

VI - commitment of the petitioner and of the agency of access to

give prior notice to the competent authority about new products or

processes obtained, or products or processes different from those stated in

the contract;

VII - obligation of the petitioner and of the agency of access to

submit to the competent authority regular reports of the results attained;

VIII - commitment of the petitioner and of the agency of access to

request prior authorization of the competent authority for the transfer or

transportation of genetic resources and derived products to areas other

than those assigned for the procedure of access;

IX - obligation to deposit samples of the genetic resource and

derived products subject to access, including any associated material, at

an institution assigned by the competent authority, single samples being

expressly prohibited to leave the Country;

X - eventual commitments of confidentiality, without prejudice to

the rights arising from traditional knowledge and to the juridical status

provided for access by this Act;

XI - eventual commitments of exclusive access for the petitioner

and the agency of access, provided that they are in compliance with the

national legislation on free competition, without prejudice to the rights

arising from traditional knowledge and to the juridical status adopted for

access by this Act;

XII - stipulation of a guarantee which ensures compensation, in the

case of non-compliance with the clauses of the contract by the petitioner

and by the agency of access;

XIII - stipulation of compensation clauses in the case of lack of

fulfillment of contract and extra-contract duties, as well as of damages to

the environment;

XIV - compliance with any other national rules, especially those

regarding sanitation control, biosafety, protection of the environment and

customs.

Article 23. The term of the contract of access shall be determined

by the competent authority, the maximum period being 3 (three) years as of

the date of its signing, renewable for periods of the same length as the

first one.

Sole paragraph. Without prejudice to other rescissory clauses

agreed upon, the competent authority may rescind the contract of access at

any time by virtue of a provision of this Act.

Article 24. The data and information contained in the petition,

proposal, authorization and in the contract of access may be subject to

confidential treatment, in case third parties may make unfair commercial

use of them, except when their disclosure is necessary to the protection of

public interest, of the environment or of rights regarding traditional

knowledge.

Paragraph 1. For the purposes stated in the caption, the petitioner

or the agency of access shall submit a justified petition, together with a

non-confidential summary, to be part of the published documents.

Paragraph 2. The confidential data shall be kept by the competent

authority and may not be disclosed to third parties, except by means of a

court order.

Paragraph 3. Confidentiality may not be applied to the information

referred to in items I, IV and V of article 15.

Article 25. The competent authority may sign, with state-owned or

public utility research centers and universities, domiciled in the Country,

agreements to provide for the carrying out of one or more contracts of

access, in compliance with the procedures stated in this Act, it being

waived, in such cases, the need to assign an institution to monitor the

activities of access, in accordance with the provisions of articles 15 and

16.

Article 26. The contracts signed in violation of this Act shall be

null and void, and their nullity may be decreed ex officio by the competent

authority, or at the petition of any person.

Section III

The Provisional Bioprospecting Contract

Article 27. Authorizations may be requested and contracts of access

may be signed without compliance with items III and VI of article 15, in

which case they shall be referred to as provisional authorizations and

contracts, in areas having their location and size defined by the competent

authority, with due regard to the ecological zoning of the Country, the

following being observed:

I - the contract mentioned in this article shall be in force for

not more than 1 (one) year) as of the date of its signing, not being

renewable;

II - the contract mentioned in this article shall provide for a

detailed report of the bioprospecting which was carried out, to be

submitted to the competent authority within 120 (one hundred and twenty)

days as of the date of expiration of the contract, and which will be

considered confidential for 1 (one) year as of the expiration of the

contract;

III - the commercial utilization of products or processes obtained

from procedures of access carried out under the terms of provisional

contracts shall not be authorized;

IV - the access to the genetic resources found in the area shall be

subject to an authorization and a contract prepared in accordance with the

previous articles;

V - the party to the contract mentioned in this article shall have

priority to receive authorization and to sign a contract of access to the

genetic resources prospected in the area, and this priority may be used

within 1 (one) year as of the expiration of the contract.

Section IV

The Additional Contracts of Access

Article 28. The additional contracts of access are those necessary

to the implementation and development of activities relating to access to

genetic resources, and that have been entered into by the petitioner or the

agency of access and:

a) the owner or holder of the natural resource which contains the

genetic resource;

b) the holder of a collection of genetic resources in ex situ or in

situ conditions;

c) the public or private institution assigned, under the terms of

this Act, to monitor the activities of access, involving obligations which

should not be part of the contract of access.

Sole paragraph. The additional contracts shall stipulate a fair and

equitable share for the parties in the benefits arising from access to the

genetic resource, the form of such sharing being expressly indicated.

Article 29. Without prejudice to the provisions of the additional

contract and notwithstanding such a contract, the public or private

institution shall be required to cooperate with the competent authority in

the monitoring and controlling of the activities of access, and to submit

reports about the activities under its responsibility, in the manner and as

often as the authority determines, the suitability to the nature of the

activities under the contract being ensured.

Article 30. The signing of an additional contract does not

authorize access to a genetic resource, and its contents must be compatible

with the provisions of the contract of access and of this Act.

Article 31. The additional contracts shall include a suspensive

clause, conditioning their implementation to the carrying out of the

contract of access.

Article 32. The nullity of the contract of access causes the

nullity of the additional contract.

Paragraph 1. The competent authority may rescind the contract of

access when the nullity of the additional contract is declared, if the

latter is essential to the completion of the access.

Paragraph 2. The alteration, suspension, or rescission of the

additional contract may imply the alteration, suspension, or rescission of

the contract of access by the competent authority, if they have a

substantial effect on the conditions of the latter.

 

Section V

The Implementation and Monitoring of the Contracts of Access

Article 33. The procedures of access must be monitored by a

Brazilian institution of education or of research, either public or

private, of undisputed repute in the area subject to the procedure,

approved by the competent authority and hired by the petitioner or by the

agency of access, before the authorization.

Sole paragraph. The institution so assigned has joint and several

liability for the fulfillment of the obligations undertaken by the

individual or corporate body authorized to carry out the procedure of

access.

Article 34. It is incumbent upon the competent authority, together

with the institution assigned to monitor the authorized activities, to

monitor the compliance with the provisions of the authorization and of the

contract of access and, especially, to ensure that:

I - access is obtained exclusively to the authorized genetic

resources and derived products, when it is not the case of a provisional

contract, and in the established area;

II - the environmental conditions of the region where the

activities take place are preserved;

III - there is permanent direct participation of an expert from the

monitoring institution;

IV - a detailed account of the activities carried out and of the

destination of the samples collected is presented;

V - samples of the species collected are handed over to be

conserved ex situ by the institution assigned by the competent authority.

Section VI

Compensation

Article 35. In addition to the payments and sharing of benefits

agreed upon by the petitioner, the agency of access, the providers of

traditional knowledge and the other parties to the additional contracts, a

fair compensation is ensured to the State, in the form of money or

commercialization rights, in the manner stipulated by the contract of

access signed by the competent authority and the other parties.

Article 36. The forms of compensation stated in this section shall

make up a special fund for the conservation, research and inventory of the

genetic patrimony, designed to be a tool of financial support to projects

related to the access to and the conservation of genetic resources and to

the knowledge associated with genetic resources.

Sole paragraph. The projects stated in this article shall be

selected by the competent authority, whose decision shall be confirmed by

the Genetic Resources Committee, subject to the availability of funds and

to compatibility with the principles established in this Act.

 

Section VII

General Provisions for the Contracts of Access

Article 37. The permits, authorizations, licenses, contracts and

other documents regarding the research, collection, acquisition, storing,

transportation, or any other similar activity related to the access to

genetic resources, in force at the date of publication of this Act, in

accordance or not with the provisions thereof, do not condition neither

presuppose the authorization for access.

Article 38. The individuals or corporate bodies authorized to

develop activities of access to genetic resources are required to transmit

to the competent authority any information regarding the transportation of

the material collected, and they also have civil, criminal and

administrative responsibility for the inadequate use or handling of such

material and for the adverse effects of such activities.

Article 39. The authorization or contract of access to genetic

resources do not imply authorization to remit them abroad, in which case

authorization must be previously requested and justified before the

competent authority.

Sole paragraph. It is totally forbidden to remit single samples

abroad, without due regard to the provisions concerning the mandatory

deposit of samples of every genetic resource or derived product which may

have been subject to access.

Article 40. It is illegal to use genetic resources and derived

products for purposes of research, conservation, industrial or commercial

applications, or any other purposes, if the access has not taken place

according to the provisions of this Act.

Article 41. The rights upon genetic resources and derived products

obtained or used in violation of this Act shall not be recognized, and the

certificates of intellectual property or similar certificates upon such

resources or derived products or upon products or processes resulting from

access under such circumstances shall not be considered valid.

Sole Paragraph. The depositors of intellectual creations subject to

protection by copyright, industrial property, crops or any other mode of

intellectual property, being based on any genetic resources or traditional

knowledge, as well as those based on the cultural or artistic traditions of

local communities or indigenous populations, must present a certificate of

approval by the communities or populations, to be obtained before

requesting legal protection of the creation and in compliance with the laws

of the country of origin of the genetic resource or of the traditional

knowledge.

 

Chapter II

The Access to Resources in Ex situ Conditions

Article 42. The competent authority may sign contracts of access to

genetic resources which are deposited in ex situ conservation centers

located in the Brazilian territory, or in other countries, provided that

Brazil is the country of origin of the resources.

Sole paragraph. The provisions regarding access to resources in in

situ conditions shall apply, where appropriate, to access to resources in

ex situ conditions.

Article 43. The genetic material transfer agreements or similar

agreements between ex situ conservation centers or between such centers and

third parties, either within the Brazilian territory or through importation

or exportation, constitute modes of contracts of access.

Paragraph 1. The conservation center providing the genetic resource

shall submit a petition of access to the competent authority, who will

publish an extract of the petition in the Official Gazette within 15

(fifteen) days as of the respective date.

Paragraph 2. The agreements stated in the caption shall be valid

provided that they are compatible with the conditions agreed upon in the

original contract of access to the resource exchanged, and with the

intellectual property rights concerned.

Paragraph 3. In its analysis of the petition of access, the

competent authority may demand financial compensation, under the terms of

this Act, which compensation shall be mentioned in the genetic material

transfer agreement or similar agreement.

Paragraph 4. In its analysis of the petition of access, the

competent authority must take into consideration the opinions presented by

any interested party.

Paragraph 5. The agreement may only be signed by the conservation

center and the interested party after validation of the proposal of

agreement by the competent authority.

 

 

TITLE IV

THE PROTECTION OF TRADITIONAL KNOWLEDGE

ASSOCIATED WITH GENETIC RESOURCES

Article 44. The State recognizes and protects the rights of local

communities and indigenous populations to benefit from their traditional

knowledge collectively, and to receive compensation for the conservation of

genetic resources, by means of payments in money, goods, services,

intellectual property rights or other mechanisms.

Paragraph 1. It is incumbent upon the Public Prosecution to take

judicial and extrajudicial measures to protect Brazilian genetic resources

and to defend the interests and rights of local communities and of

indigenous populations.

Paragraph 2. The competent authority shall create a national

reference file, where the local communities, the indigenous populations,

and any other interested party may deposit records of knowledge associated

with genetic resources.

Paragraph 3. Every record deposited in the national reference file

shall be submitted to an ethnologic appraisal, and shall be used as a basis

for decisions concerning the terms of the contract of access.

Paragraph 4. By means of agreements, the collections of traditional

knowledge belonging to other institutions, either Brazilian or foreign, may

be deposited in the national reference file, for the same purpose of the

preceding paragraph.

Paragraph 5. The records mentioned in this article are not

mandatory, and their non-existence are not a condition for, neither does it

preclude the exercise of any right set forth in this Act.

Article 45. The local communities and indigenous populations have

exclusive rights over their traditional knowledge, and they alone are

entitled to surrender them, by means of the types of contract set forth in

this Act.

Sole paragraph. The proposal of contract of access may only be

accepted if it is preceded by justified prior consent of the local

community or indigenous population, obtained according to clear and precise

rules which shall be stipulated for this procedure by the competent

authority.

Article 46. The local communities and indigenous populations are

ensured of the right to the benefits arising from access to genetic

resources carried out in the areas they inhabit, defined under an

additional contract referred to in this Act, and following justified prior

consent as stated in the preceding article.

Sole paragraph. The local communities and indigenous populations

may request that the competent authority deny access to genetic resources

in the areas they inhabit, if they believe that such activities threaten

the integrity of their natural or cultural patrimony.

Article 47. Intellectual property rights with respect to products

or processes related to traditional knowledge associated with genetic

resources or derived products shall not be recognized if the access has not

taken place according to the provisions of this Act.

 

TITLE V

TECHNOLOGY DEVELOPMENT AND TRANSFER

Article 48. The State shall promote and support the development of

national sustainable technologies for the study, use and improvement of

autochthonous species, lineages and varieties, and shall support the

traditional uses and practices of local communities and indigenous

populations.

Sole paragraph. For the purposes of this article, the State shall

promote the survey and evaluation of national and traditional

biotechnologies.

Article 49. The use of foreign biotechnologies will be permitted,

whenever these comply with this Act and with other regulations on

biosafety, and the interested company takes full responsibility for any

damage to health, the environment or traditional cultures.

Article 50. Arrangements shall be set up to guarantee and

facilitate, for the national researchers and providers of genetic

resources, the access to and transfer of technologies that are relevant to

the conservation and sustainable use of biological diversity, or that use

genetic resources without harming the natural and cultural environment of

the Country.

Article 51. In the case of technologies which are subject to

patents or other intellectual property rights, it shall be guaranteed that

the procedures of access and transfer of technology shall be effected with

adequate protection to such rights.

 

 

TITLE VI

VIOLATIONS AND ADMINISTRATIVE AND CRIMINAL SANCTIONS

Article 52. The conducts and activities which violate the

provisions of this Act shall be punished with administrative and criminal

sanctions.

Sole paragraph. The administrative and criminal sanctions may be

cumulative, being independent from each other.

Article 53. As to the violations defined in this Act, liability

falls upon the abettor, principal, director, administrator, member of the

board and of the technical agency, auditor, manager, representative, or

agent of a corporate body who, being informed or having the duty to be

informed of the criminal conduct of a third person, fails to prevent such a

conduct while having the power to act to prevent it.

Article 54. The corporate bodies shall be sentenced as provided in

this Act, whenever the violation is perpetrated upon decision taken by

their legal or contractual representatives, or by their collegiate bodies,

in the interest or to the benefit of such entities.

Sole paragraph. The liability of corporate bodies does not preclude

that of individuals, authors, co-authors, or persons participating in the

same action.

Article 55. Without prejudice to the provisions of this Act, the

agent, whether he is guilty or not, is required to compensate the damages

caused to the environment and to third parties affected by his actions.

Article 56. The acquisition and commercialization of genetic

resources and derived products, as well as their remittance abroad, and the

use of traditional knowledge, without the authorization stated in this Act,

constitute a crime subject to imprisonment of 1 (one) to 4 (four) years,

and a fine of up to 10,000 (ten thousand) times the daily fine stipulated

in the following article.

Sole paragraph. In the case of repeaters, the fine shall be doubled.

Article 57. The Executive Branch shall establish regulations

containing the cases for application of each one of the following sanctions

to the violations of this Act:

I - admonishment;

II - simple fine;

III - daily fine;

IV - seizure of the animals, products and subproducts of the fauna

and flora, instruments, tools, equipment, or vehicles of any nature used in

the violation;

V - destruction or damaging of the product;

VI - suspension of commercialization of the product;

VII - embargo of the activity;

VIII - partial or total closure of the business, activity or undertaking;

IX - suspension of the legally required registration, license or

authorization;

X - cancellation of the legally required registration, license or

authorization;

XI - loss or reduction of fiscal incentives and benefits granted by

the government;

XII - loss or suspension of right to receive financing from

official funding agencies;

XIII - intervention in the business;

XIV - prohibition to enter into contracts with the Public

Administration for a period of up to three years.

Sole paragraph. The sanctions set forth by this article shall be

applied without prejudice to the applicable civil or criminal proceedings.

 

 

TITLE VII

FINAL PROVISIONS

Article 58. The Executive Branch shall set forth regulations

concerning this Act within 180 (one hundred and eighty) days as of the day

of its publication.

Article 59. This Act shall come into force on the date of its

publication.

Article 60. All provisions to the contrary are hereby revoked.