HANDBOOK

of Access to Brazilian
Genetic Heritage
and Associated
Traditional Knowledge

Ana Claudia Dias de Oliveira

2
HANDBOOK
of Access to Brazilian
Genetic Heritage
and Associated
Traditional Knowledge

Ana Claudia Dias de Oliveira

Publishing Prefix: 53016
ISBN number: 978-85-53016-00-6
Title: Handbook of access to Brazilian genetic
heritage and associated traditional knowledge
Media type: E-book
E-book format: PDF
 Author • Ana Claudia Dias de Oliveira
Portuguese editing • Marcelo Nogueira
Translation • Alpha Language Consulting
English editing • Maria Lúcia Daflon
Design • Luciana Costa Leite
Photos • Cristina Ropke and Marcelo Nogueira
Cover photo • Peter Eaton

Production Institutional support

 I thank my family,
Marcelo, Carolina and Helena
for being my strength,
my love and my essence.
contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Law n. 13.123/15 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Law n. 13.123/15 - Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Important concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Cbd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Law n. 13.123/15 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Analysis and comparison of CBD and Law n. 13.123/15 concepts . . 32
Genetic Resource (CBD) and Genetic Heritage (Law n. 13.123/15) . . 32
ATK and ATK of non-identifiable origin . . . . . . . . . . . . . . . . . . . . . 34
Research & Technological Development . . . . . . . . . . . . . . . . . . . . . 35
Access to Genetic Heritage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Access to Associated Traditional Knowledge . . . . . . . . . . . . . . . . . . 40
In situ Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Provider and User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Shipping and Forwarding of Genetic Heritage . . . . . . . . . . . . . . . . 42
Finished Product and Intermediate Product . . . . . . . . . . . . . . . . . . 46
Verification Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Key concepts for the agrarian sector (Law n. 13.123 /15) . . . . . . . . 50
8
CGEN - Genetic Heritage Management Council . . . . . . . . . . . . . . . 51
CGEN Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
CGEN Attributions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Benefit Sharing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Benefit Sharing Modalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Liability of Benefit Sharing Payment . . . . . . . . . . . . . . . . . . . . . . . . 55
Exemption of Benefit Sharing Payment . . . . . . . . . . . . . . . . . . . . . . 56
Benefit Sharing from Foreign Products with Brazilian
Genetic Heritage Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Benefit Sharing from Agrarian Products . . . . . . . . . . . . . . . . . . . . . 58
Sectoral Agreements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Benefit Sharing Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Administrative Sanctions of Law n. 13.123/15 . . . . . . . . . . . . . . . . . 61
National Fund for Benefit Sharing - FNRB . . . . . . . . . . . . . . . . . . . . 63
National Benefit Sharing Program - PNRB . . . . . . . . . . . . . . . . . . . . 64
Adequacy and Regularization of Activities . . . . . . . . . . . . . . . . . . . 65
Intellectual Property . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Application of Law n. 13.123/15 . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Non-Application of Law n. 13.123/15 . . . . . . . . . . . . . . . . . . . . . . . 69
General guidelines per type of activity . . . . . . . . . . . . . . . . . . . . . . 70
General guidelines for Research with Brazilian
Genetic Heritage Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
General guidelines for Research with Shipping of
Brazilian Genetic Heritage Components . . . . . . . . . . . . . . . . . . . . . 71
General guidelines for Research with Forwarding of
Brazilian Genetic Heritage Components . . . . . . . . . . . . . . . . . . . . . 72
General guidelines for Technological Development
without Access to Associated Traditional Knowledge . . . . . . . . . . 73
9
 General guidelines for Research and/or Technological
Development with Associated Traditional Knowledge of
identifiable origin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
General guidelines for Research and/or Technological
Development with Associated Traditional Knowledge of
non-identifiable origin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
SisGen Registration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
SisGen Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Filling the Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Confidentiality of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Registration Certificate and Receipt . . . . . . . . . . . . . . . . . . . . . . . . 78
User Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Institution Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Access and Forwarding Registration . . . . . . . . . . . . . . . . . . . . . . . . 84
Activity of Access to Genetic Heritage & Associated
Traditional Knowledge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
About Accessed Genetic Heritage Component . . . . . . . . . . . . . . . . 94
About Associated Traditional Knowledge . . . . . . . . . . . . . . . . . . . 102
Partnership with a National Institution . . . . . . . . . . . . . . . . . . . . . 107
Partnership with an Overseas-based Institution . . . . . . . . . . . . . . . 109
Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Forwarding Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
About Genetic Heritage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Specification of Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Overseas Recipient Institution . . . . . . . . . . . . . . . . . . . . . . . . . 115
Legal Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Shipping Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Type of User and the Responsible for Registration . . . . . . . . . . 116
Object of Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Connection with a previous Access Registration . . . . . . . . . . . . 119
Material Transfer Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
10
 Overseas Access Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
About the Genetic Heritage Component to be shipped . . . . . . 120
Taxonomic identification of genetic heritage component . . . . . 123
About Genetic Heritage Origin . . . . . . . . . . . . . . . . . . . . . . . . 125
Sample Types and Packing Methods . . . . . . . . . . . . . . . . . . . 130
Overseas Recipient Institution . . . . . . . . . . . . . . . . . . . . . . . . 132
Required Authorization for Access or Shipping . . . . . . . . . . . . . . . 133
Additional Registration Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Notification Finished Product or Reproductive Material about . . . . 136
Benefit Sharing Modality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Exemption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Genetic Heritage - Monetary Modality . . . . . . . . . . . . . . . . . . . . . 140
Genetic Heritage - Non-Monetary Modality . . . . . . . . . . . . . . . . . . 141
Associated Traditional Knowledge of Non-identifiable Origin
- Monetary Modality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Associated Traditional Knowledge of Identifiable Origin
- Monetary or Non-Monetary Modality . . . . . . . . . . . . . . . . . . . . 145
Verification Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Access Regularity Certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Accreditation of Institution that Maintains ex-situ Collection . . . . . 153
Collection Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Type of Preserved Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Curator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

11
12
Introduction

Law n. 13.123/15 (Biodiversity Law) defines new rules for

access to Genetic Heritage and Associated Traditional
Knowledge, also covering the Sharing of Benefits.
Effective as of November 17, 2015, it revokes the
Provisional Presidential Decree n. 2.186-16/01. In 2016,
it was regulated by Decree n. 8.772/16.

This Handbook contains an annotated reading of

the Biodiversity Law and systematized information
to facilitate the legalization of those who integrate the
chain using Brazilian Genetic Heritage and Associated
Traditional Knowledge.

Besides a more detailed understanding of the system, this

Handbook includes charts for better clarification on who
is liable to pay benefit sharing in each type of activity,
as well as on the procedures provided by law and filing
instructions for the required registration.

This Handbook is not intended to exhaust the subject, but

to serve as initial reference for researchers, technicians,
representatives of traditional communities, teachers,
entrepreneurs and managers, among others.

Reading it does not eliminate the need for further

studies or specialized consultation on the most
pertinent aspects of your research or technological
development project. But it will surely be useful to
all who work with Access to Genetic Heritage and
Associated Traditional Knowledge, not only to avoid
legal penalties, but mainly to contribute to a more
rational, sustainable and environmentally responsible
access to these priceless assets.

13
14
Law n. 13.123/15
History
Law n. 13123/15, passed in Brazil by Legislative Decree n. 2 of 1994 and enacted by
Decree n. 2.519 of March 16, 1998, resulted from a broad discussion on biodiversity,
started even before the Convention on Biological Diversity - CBD took place.

The concept of sustainable development started to be debated worldwide with the publi-
cation of a report prepared by the World Commission on Environment and Development,
entitled “Our Common Future”, also known as the Brundtland Report, published in 1987.
The CBD discussions also started in 1987, with the passing of Decision n. 14/26 by the
Governing Council of the United Nations Environment Program - UNEP, which predicted
the creation of a group of biodiversity experts intended to harmonize the existing conven-
tions on this matter.

In 1988, 20 years after Sweden proposed the Stockholm

Conference (First United Nations Conference on the Human
Environment, held in 1972), the General Assembly of the
United Nations - UN passed Resolution n. 43/196 for a new
conference focusing on environmental issues. In 1989,
the General Assembly adopted Resolution 44/228 and
convened the United Nations Conference on Environment
and Development, or Rio-92, for June 1992.

Besides raising awareness among society, Rio Earth Summit (also known
as Rio de Janeiro Summit, Rio Conference or Earth Summit) resulted in
the following official documents: The Earth Charter; three conventions (the Convention
on Biological Diversity – on the protection of biodiversity; the United Nations Convention
to Combat Desertification – on the reduction of desertification; and the United Nations
Framework Convention on Climate Change – about the global climate issue); the Forest
Principles; Rio Declaration on Environment and Development; and Agenda 21.

The Convention on Biological Diversity is an agreement approved during Rio Earth Summit
by 156 countries and one Regional Economic Integration Organization. It was amended
by the Brazilian National Congress and entered into force in the end of December 1993.
15
In 1995, Senator Marina Silva (PT-Acre) presented Bill 306/95. After long debate in the
Senate, Senator Osmar Dias (PSDB/PR) offered a substitute, Bill n. 4.842/98, passed
by the Senate and submitted to the Chamber of Deputies in the end of 1998. The Bill
authored by Marina Silva incorporated the term and the concept of “genetic resources”
adopted by the CBD, which made the matter easier to understand.

Meanwhile, Deputy Jacques Wagner (PT-BA) and the Executive forwarded Bills n.
4.579/98 and 4.751/98 to the Chamber of Deputies, to rescue some aspects of the
original proposal of Senator Marina Silva and to incorporate adjustments resulting from
the discussion of this proposal.

Later that same year, the Federal Executive Power, based on a study carried out by
an inter-ministerial group coordinated by the Ministry of Environment, submitted Bill
4.751/98 and Amendment Bill 618/98 to the Chamber of Deputies.

In 2000, in face of the negative repercussions of an agreement signed between a Swiss

company and a Brazilian Social Organization (SO), the Brazilian government issued a
Provisional Decree regulating access to genetic resources and biodiversity-associated
traditional knowledge, MP 0252/00, which, in its Sect. 10, included the possibility of
right to exploit any traditional knowledge in the Country:

A person of good faith who, by June 30, 2000, used or economically benefitted from
any traditional knowledge in the Country shall be entitled to continue using or ben-
efitting from it, free of charge, under the previous form and conditions.

The agreement did not provide for any fair form of benefit sharing (an evident contradic-
tion to the CBD’s prescripts) and has been suspended due to negative manifestations
among civil society.

At the end of these negotiations, Provisional Decree n. 2.186-16 of 2001 entered

into force. This PD has been monthly reissued, until the publication of Constitutional
Amendment n. 32/01, which stipulated that published PDs would remain in force until
their final review by the Brazilian Congress. Its last reprint was the publication of PD
2.186-16 (Constitutional Amendment n. 32/01), later regulated by Decrees n. 3.945/01
and 4.946/03, whose main objectives were access and shipping of genetic heritage
components, access to and protection of associated traditional knowledge, and fair and
equitable sharing of benefits.

The main aspects discussed in PD n. 2.186-16/01 were the need to obtain authoriza-
tion for access from the CGEN (Genetic Heritage Management Council); the definition
16
of CGEN authorization conditions – including the need for prior consent from the area
owner and/or the holder or provider of associated traditional knowledge; the obligation
of a benefit sharing agreement with the provider for the establishment of access and
benefit sharing conditions; and contract validation only after approval from the CGEN –
which, having been created by PD n. 2.186-16/01, only had its wording and operating
rules established by Decree n. 3.945, published on September 28, 2001. The period
between the creation of the CGEN and its subsequent regulation raised some questions
on notifications and penalties applied as of 2000.

A controversial issue resulting from PD n. 2.186-16/01 concerned both collection and

access rules. In this PD, the concept of access was mixed up with that of collection: the
concept of access to genetic heritage was defined as “obtaining a sample of genetic
heritage for purposes of scientific research, technological development or bioprospec-
tion, aiming at industrial application or other”, which for many could be considered as
the definition for the concept of collection. Issues arose, such as: Could there be collec-
tion without access? Could there be access to genetic heritage without collection? In
both cases, the answer is affirmative. There may be collection without access, when the
researcher only collects and ships the material to another researcher or institution. And
there may be access to genetic heritage without collection, in case of access to biological
material conserved or maintained in ex-situ collections. Other hindrances arising from PD
n. 2.186-16 were: bureaucratization, due to the excess of conditioning requirements for
authorizations; pre-fixed compensations, not considering the proportion or the impact
of the damage; absence of a transition rule, which led to the suspension of processes at
17
CGEN; lack of regulatory mechanisms; disproportionate penalties as to product profit-
ability, due to the absence of a calculation basis; delays and increased costs of develop-
ment processes, due to difficulties in obtaining permissions; juridical insecurity in the
access to Associated Traditional Knowledge, due to lack of regulation and the possibility
of existence of other traditional communities also in possession of that knowledge; and
uncertainty about future changes in legislation, as published Technical Guidelines and
Resolutions have often been disregarded.

Almost 14 years after the first issue of PD n. 2 .186-16 / 01, on June 20, 2014, a
presentation by the Ministers of the Environment - MMA, of Development, Industry
and Commerce - MDIC, and of Science, Technology and Innovation - MCTI, about the
Draft Bill on Access to Genetic Heritage, Associated Traditional Knowledge and Benefit
Sharing, was forwarded to the Brazilian Congress. Not long after that, on June 24, 2014,
this project was presented as Bill 7735/14. Bill 7735/14 received 222 amendments, was
voted in its final wording on February 10, 2015, and forwarded to the Senate on April
22, 2015 as a Chamber of Deputies Law Project - PLC 2/15, passed with amendments
and sent to sanction on April 29, 2015.

Bill n. 7735/14 and its successor, PLC n. 02/15, have brought many advances to the
legislation. A change of mindset has been noticed as researchers and technicians are
not anymore seen as “villains”, but as part of a system interested in prospecting
products and processes of the Brazilian biodiversity with environmental responsibility
and sustainable goals.
18
These bills contained well-defined concepts, which resulted in more juridical security;
incentives to the use of Brazilian biodiversity; international competitiveness; sharing of
monetary and non-monetary benefits; regularization due to its proposed inclusive sys-
tem; and, above all, more mature analyses and discussions, after a consensus with
different sectors, including the pharmaceutica, cosmetics, biotechnology and agricul-
ture industries. Intentions behind the passing of these bills were debureaucratization, a
trustful mapping of R&D programs with products of the Brazilian biodiversity, fair and
equitable sharing of benefits, incentive to RD&I based on biodiversity, and technological
development with environmental and social responsibility.

What is new in the wording of Law n. 13.123/15 is:

Inclusion of new concepts.

Registration.

Benefit Sharing (BS) only for finished products or at the last link of reproductive
materials production chain.

BS exemption to intermediaries and process developers as well as to small

businesses, micro-entrepreneurships and individual businesses.

Possibility of non-monetary BS with traditional communities.

BS agreement within 1 year of notification on the finished product.

Monetary Benefit Sharing of 1% of the annual net revenue.

Possibility of Sectoral Agreements for BS reduction.

Creation of the National Fund for Benefit Sharing - FNRB.

Within this context, Provisional Decree n. 2.186-16 remained as a legal landmark of

access to Brazilian genetic heritage and associated traditional knowledge for 15 years,
until the publication of Law n. 13.123/15.

Law n. 13.123/15 was regulated by Decree n. 8772, of May 11, 2016.

Benefits of the law can only be measured a few years after these activities have been im-
plemented in the country. However, the paradigm shift and the pioneering spirit of Brazil
in drafting a law on Access to Genetic Heritage, its Associated Traditional Knowledge
and the Sharing of Benefits raised the discussion to a higher level of maturity, allowing
the participation of the several levels of society.

19
20
Law n. 13.123/15 - Summary

Law 13.123, also referred to as the Biodiversity Law, was published on May
20, 2015, summarized with the following syllabus:

Regulates Subsection II of § 1 and § 4 of Sect. 225 in the

Federal Constitution, Section 1, clause (j) of Section 8,
clause (c) of Section 10, Section 15 and §§ 3 and 4 of
Section 16 of the Convention on Biological Diversity,
enacted by Decree n. 2.519, of March 16, 1998; rules on the
access to genetic heritage, the protection and access
to Associated Traditional Knowledge and the
sharing of benefits for conservation and
sustainable use of biodiversity; revokes
Provisional Decree n. 2.186-16 of August 23,
2001; among other provisions.

Caput of Sect. 225 of the Federal Constitution provides that:

Sect. 225. Everyone has the right to an ecologically balanced environment,

an asset of common use, essential for a healthy quality of life, being public
authorities and collectivity committed to the duty of defending and protecting
it for present and future generations.

Subsection II, § 1 of Sect. 225 defines governmental responsibilities to ensure

effectiveness of the rights described in this section’s caput:

§ 1 To ensure effectiveness of this right, official authorities are entrusted to: (...)

II - Preserve diversity and integrity of the Country’s genetic heritage and super-
vise entities dedicated to research and manipulation of genetic material.
21
§ 4 of Sect. 225 defines what should interpreted as national heritage and indicates that
there are conditions for its use:

§ 4 The Brazilian Amazon Rainforest, the Atlantic Forest, Serra do Mar, Pantanal
Mato-grossense and the Coastal Zone make up Brazil’s national heritage, and
their use must be in accordance with the law, under conditions that ensure
preservation of the environment, also in regard to the use of natural resources.

Law n. 13.123/15 also regulates some stipulations of the Convention on Biological

Diversity: Section 1, clause (j) of Section 8, clause (c) of Section 10, Section 15
and §§ 3 and 4 of Section 16:

Section 1 - Objectives

Objectives in this Convention, to be pursued according to relevant provisions, are

the conservation of biological diversity, the sustainable use of its components
and the fair and equitable sharing of benefits arising from the use of genetic
resources, through appropriate access to genetic resources and appropriate
transfer of relevant technologies, taking into account all rights over these
resources and technologies, as well as through appropriate funding.

22
Section 8 - In-situ Conservation

Each Contracting Party shall, as far as possible and according to the case:

j) In regard of its national legislation, respect, preserve and maintain knowl-

edge, innovations and practices of indigenous and local communities embody-
ing traditional lifestyles relevant for the conservation and the sustainable use
of biological diversity; promote their wider application with the approval and
the involvement of the holders of such knowledge, innovations and practices;
and encourage the equitable sharing of benefits arising from the use of such
knowledge, innovations and practices.

Section 10 - Sustainable Use of Biological Diversity Components

Each Contracting Party shall, as far as possible and as appropriate:

c) Protect and encourage the customary use of biological resources in accord-

ance with traditional cultural practices compatible with conservation or sus-
tainable use requirements.

Section 15 - Access to Genetic Resources

1. In recognition of the sovereign rights of States over their natural resources,

authority to determine access to genetic resources rests with national govern-
ments and is subject to national legislation.

2. Each Contracting Party shall endeavor to create conditions to facilitate ac-

cess to genetic resources for environmentally salutary uses by other Contract-
ing Parties and not impose restrictions running counter to the objectives of this
Convention.

3. For the purposes of this Convention, genetic resources being provided by

a Contracting Party, to which this Section and Sections 16 and 19 applies, are
only those provided by Contracting Parties representing the countries of origin

23
of such resources or by the Parties that have acquired them in accordance with
provisions in this Convention.

4. Access, when granted, shall be on mutually agreed terms, being subject to

the terms of this Section.

5. Access to genetic resources shall be subject to prior informed consent of the

Contracting Party providing such resources, unless otherwise determined by
this Party.

6. Each Contracting Party shall endeavor to develop and carry out scientific
research based on genetic resources provided by other Contracting Parties with
their full participation and, if possible, in the territories of these Contracting
Parties.

7. Each Contracting Party shall take legislative, administrative or policy meas-

ures, as appropriate, and in accordance with Sections 16 and 19, and, when
necessary, through the financial mechanism established by Sections 20 and 21,
aiming to share, in a fair and equitable way, results of research and develop-
ment projects with genetic resources, and the benefits arising from its commer-
cial utilization, or other, with the Contracting Party providing such resources.
Sharing shall be agreed upon mutual terms.

Section 16 - Access to Technology and Transfer of Technology (...)

3. Each Contracting Party shall take legislative, administrative or policy meas-

ures, as appropriate, so that Contracting Parties, in particular those represent-
ing developing countries providing genetic resources, are granted access to
the technology that makes use of such resources, with right of technology
transfer on mutually agreed terms, including technology protected by patents
and other intellectual property rights, when necessary, as disposed in the terms
of Sections 20 and 21, in accordance with international law and in consistency
with §§ 4 and 5 below.

4. Each Contracting Party shall take legislative, administrative or policy meas-

ures, as appropriate, to make sure that the private sector facilitates access to
the technology referred to in paragraph 1 above, as well as its joint develop-
ment and transfer, for the benefit of both government institutions and the
private sector of developing countries, and, in this regard, they shall abide by
the obligations included in §§ 1, 2 and 3 above.
24
25
Important concepts
CBD
The CBD provides the definition of some important terms for reading and interpreting the
Biodiversity Law:

Protected area a geographically defined area designated, or regulated, and managed

to achieve specific conservation objectives.

Biotechnology any technological application using biological systems, living organisms,

or derivatives thereof, to make or modify products or processes for specific uses.

In-situ conditions conditions in which genetic resources exist within ecosystems

and natural habitats, and, in the case of domesticated or cultivated species, in the sur-
roundings where they have developed their distinctive agrarian characteristics.

Ex-situ conservation conservation of biological diversity components outside their

natural habitats.

In-situ conservation conservation of ecosystems and natural habitats and mainte-

nance and recovery of viable populations of species in their natural surroundings and,
in the case of domesticated or cultivated species, in the surroundings where they have
developed their distinctive characteristics.

Biological diversity the variability of living organisms from different origins, including,
inter alia, terrestrial, marine and other aquatic ecosystems, as well as the ecological
complexes of which they are part; also considering intraspecific and interspecific diversity
and ecosystems diversity.

Ecosystem a dynamic complex of plant, animal and microorganism communities and

their non-living environment interacting as a functional unit.

Domesticated or cultivated species species in which the evolutionary process has

been influenced by humans to meet their needs.

Habitat the place or type of site where an organism or population naturally occurs.

Genetic material any material of plant, animal, microbial or other origin containing
functional units of heredity.

26
Regional economic integration organization an organization constituted by sov-
ereign States of a given region, to which its member States have transferred competence
in respect of matters governed by this Convention and which has been duly authorized,
in accordance with its internal procedures, to sign, ratify, accept, approve or accede to it.

Country of origin of genetic resources the country that possesses genetic resources
at in-situ conditions.

Country providing genetic resources country supplying genetic resources col-

lected from in-situ sources, including populations of both wild and domesticated species
or taken from ex-situ sources, which may or may not have originated in that country.

Biological resources genetic resources, organisms or parts thereof, populations,

or any other biotic component of ecosystems with actual or potential use or value for
humanity.

Genetic resources genetic material of real or potential value.

Technology term that encompasses the concept of biotechnology.

Sustainable use use of components of biological diversity in a way and at a rate

that does not lead to the long-term decline of biological diversity, thereby maintaining its
potential to meet the needs and aspirations of present and future generations.

27
Law n. 13.123/15
Sect. 2 of Law 13.123/15 included some important concepts. A few of these
came to supplement the definitions in the CBD:

Genetic heritage (GH) information on the genetic origin of vegetal, animal and
microbial species, or species of other nature, and on the substances derived from the
metabolism of those living beings.

Associated traditional knowledge (ATK) information or practice of indigenous

populations, traditional communities or traditional farmers on properties or direct and
indirect uses associated to genetic heritage.

Associated traditional knowledge of non-identifiable origin associated tradi-

tional knowledge whose origin cannot be connected to at least one indigenous popula-
tion, traditional community or traditional farmer.

Traditional community self-recognized culturally distinct group, with its own form
of social organization, that occupies and uses territories and natural resources as a condi-
tion for its cultural, social, religious, ancestral and economic reproduction, using knowl-
edge, innovations and practices generated and transmitted by tradition.

Provider of associated traditional knowledge indigenous population, traditional

community or traditional farmer that holds and provides information on associated tradi-
tional knowledge to be accessed.

Prior informed consent formal consent previously granted by indigenous popula-

tion or traditional community, according to its communal uses, customs and traditions
or protocols.

Community protocol procedural rules of indigenous populations, traditional com-

munities or traditional farmers that establish, according to their usages, customs, and
traditions, mechanisms for Access to Associated Traditional Knowledge and the sharing
of benefits, as provided for by this Law.

Access to genetic heritage research or technological development conducted on a

genetic heritage sample.

Access to associated traditional knowledge research or technological develop-

ment conducted on traditional knowledge associated with genetic heritage, which allows
or facilitates access to genetic heritage components, even if obtained from secondary
28
sources, such as fairs, publications, inventories, movies, scientific articles, registers and
other forms of systematization and recording of associated traditional knowledge.

Research experimental or theoretical activity conducted on genetic heritage or as-

sociated traditional knowledge, aiming to produce new knowledge through a systematic
process of knowledge construction, which generates and tests hypotheses and theories,
and describes and interprets the foundations of observable phenomena and facts.

Technological development systematic work on genetic heritage or on associated

traditional knowledge, based on existing procedures obtained through research or practi-
cal experience, aiming to develop new materials, products or devices, and to improve or
develop new processes for economic use.

Register of access and/or shipping of genetic heritage or associated traditional

knowledge required declaratory instrument on the activities of access or shipping of
genetic heritage or associated traditional knowledge.

Shipping transfer of a genetic heritage sample to an institution located outside the

Country, to allow access to it, in which the responsibility for the sample is transferred to
the recipient.

Access or shipping authorization administrative act to consent, under specific

conditions, access to genetic heritage or associated traditional knowledge and shipping
of genetic heritage.

User natural or legal person who accesses genetic heritage or associated traditional
knowledge or who economically benefits from the finished product or reproductive ma-
terial derived from access to genetic heritage or associated traditional knowledge.

Finished product a natural product that does not require any additional production
processes, derived from the access to genetic heritage or associated traditional knowl-
edge, in which the component of genetic heritage or associated traditional knowledge is
one of the main elements of value-adding, being suitable for use by the final consumer,
either a natural or a legal person.

Intermediate product a product to be used in a productive chain, being aggregated

to its production process as an input, excipient or raw material, for the development of
another intermediate product or of a finished product.

Main elements of value-adding for a product elements which, when present

in a finished product, turn out to be essential for its functional characteristics or for the
formation of market appeal.
29
Product notification a declaratory instrument that precedes economic activities with
either finished products or reproductive materials derived from access to genetic heritage
or associated traditional knowledge, in which the user declares to be compliant with the
requirements of this Law and indicates the benefit sharing modality, when applicable, to
be established in the benefit sharing agreement.

Benefit sharing agreement legal instrument that characterizes the parties, the
object and the conditions of benefit sharing.

Sectoral agreement contractual act signed between the Government and users, for
the fair and equitable sharing of benefits resulting from economic activity derived from
access to genetic heritage or associated traditional knowledge of non-identifiable origin.

Regular access certificate administrative act by which the competent agency states
that the access to genetic heritage or associated traditional knowledge follows the provi-
sions of this Law.

Material transfer term instrument signed between sender and recipient for overseas
shipping of one or more samples containing accessed or available-for-access genetic her-
itage, indicating, when applicable, access to associated traditional knowledge, and the
establishing of mandatory benefit sharing, under the rules provided by this Law.

30
31
Analysis and comparison of CBD and
Law n. 13.123/15 Concepts.
Genetic resource (CBD) and Genetic Heritage
(Law n. 13.123/15)
The CBD establishes the concept of “genetic material” and “genetic resource” as a
material, that is, as a physical sample. The Biodiversity Law complements this concept by
replacing the word “resource” with “heritage” and including the word “information”, so
that the concept can be used not only for physical samples but also for any information
derived from them:

CBD
Genetic Material
Any material of plant, animal, microbial
or other origin containing functional units of heredity.

CBD
Genetic Resources
Genetic material of real or potential value.

Law n. 13.123/15
Genetic Heritage
Information on the genetic origin of vegetal, animal and
microbial species, or species of other nature, and on substances
derived from the metabolism of these living beings.

32
Decree n. 8.772/16

A microorganism is part of the existing national genetic

heritage when it has been isolated from national territory
substrates, the territorial sea, the exclusive economic zone
or the continental shelf.

A microorganism will not be considered as a component

of national genetic heritage if the user shows that
it has been isolated from substrates not belonging
to the national territory, the territorial sea, the
exclusive economic zone or to the continental
shelf, and if it is possible to prove the regularity of
its import.

Plant and animal species introduced in the Country will only

be considered genetic heritage found at in-situ conditions
in the national territory when they form spontaneous
populations that have acquired their own distinctive
characteristics.

Equally considered as genetic heritage component

found at in-situ conditions is a variety resulting from
species introduced to the national territory, with genetic
diversity developed or adapted by indigenous populations,
traditional communities or traditional farmers, also
by natural selection combined
with human selection in the local
environment, and not substantially
similar to commercial cultivars.

33
ATK and ATK of non-identifiable origin
Law n. 13.123/15 enhances the concepts relating to Traditional Knowledge, including
the traditional farmer and creating the concept of Associated Traditional Knowledge of
non-identifiable origin, in which it is not possible to associate the knowledge to a single
traditional community.

PD n. 2.186-16/01
Associated Traditional Knowledge - ATK

Individual or collective information or practice from

indigenous or local communities, of real or potential value,
associated with genetic heritage.

Law n. 13.123/15 Law n. 13.123/15

Associated Traditional Associated Traditional
Knowledge Knowledge of non-
identifiable origin
Information or practice
of indigenous population, Associated traditional
traditional community Knowledge whose origin
or traditional farmer on can not be related to at least
properties or direct and one indigenous population,
indirect uses associated to traditional community or
genetic heritage. traditional farmer.

34
 Law n. 13.123/15
Ways to recognize Associated Traditional
Knowledge, among others, are:

I • Scientific publications.
II • Registers or databases.
III • Cultural inventories.

Research and Technological Development

Law n. 13.123/15 enhanced PD n. 2.186-16/01, suppressing the concept of bioprospect-
ing, while maintaining the concepts of Research and Technological Development. This was
an important step towards a wider understanding of Access to Genetic Heritage activities.
While Provisional Decree n. 2.186-16/01 was in force, the concept of Bioprospecting was
often mixed up with the concepts of Research and Development. What determined the
end of the research phase and the beginning of the prospecting phase? At what point
bioprospecting started to be named as a technological development?

35
 Technical Guidance CGEN n. 7/09
Research
Group of activities aimed at the selection of promising genotypes
for bioprospecting activities.
(no concept in PD n. 2.186-16/01)

Law n. 13.123/15
Research
Experimental or theoretical activity conducted on genetic heritage or
associated traditional knowledge, aiming to produce new knowledge
through a systematic process of knowledge construction, which
generates and tests hypotheses and theories, and describes and interprets
the foundations of observable phenomena and facts.

PD n. 2.186-16/01
Bioprospecting
Exploratory activity to identify genetic heritage components and
information on associated traditional knowledge with potential
commercial use.

Law n. 13.123/15
Bioprospecting
Suppressed concept

36
 Technical Guidance CGEN n. 4/04
Technological Development
Systematic work, arising from existing knowledge, aimed at the production of
specific innovations, and at the elaboration or modification of existing products
or processes, with an economic purpose. (no concept in PD n. 2.186-16/01)

Law n. 13.123/15
Technological Development
Systematic work on genetic heritage or on associated traditional knowledge,
based on existing procedures obtained through research or practical
experience, conducted to develop new materials, products or devices,
and to improve or develop new processes for economic exploitation.

Access to Genetic Heritage

The concept of access to genetic heritage has been enhanced to suit the changes in the
new law. The changes consisted in excluding the terms “sampling from genetic heritage
components” and “bioprospecting”, to make the purpose of research or technological
development clear.

PD n. 2186-16/01 Law n. 13.123/15

Access to Genetic Heritage Access to Genetic
Heritage
Sampling from genetic heritage
component for scientific research, Research or technological
bioprospecting or technological development conducted
development purposes, aiming at their on a genetic
industrial application or other. heritage sample.

37
38
 Decree n. 8.772/16

Access to genetic heritage or associated traditional

knowledge performed by June 30, 2000, and
the economic utilization of finished product or
reproductive material resulting from such access
are not subject to the requirements of Law
n. 13.123/15, and of this Decree.

Decree n. 8.772/16

To prove that the access to Genetic Heritage or Associated Traditional Knowledge as well
as the economic use of finished product or resulting reproductive material have been
performed before June 30, 2000, when asked by the qualified authority, the user must
provide evidence that all the steps of the access had been finished prior to June 30,
2000, by means of:

• In the case of research:

a) Publication of article in a scientific journal.
b) Announcement in scientific events.
c) Receipt of patent application.
d) Report on the finalized research at the public funding agency or entity.
e) Publication of course completion papers, master’s dissertation or doctoral thesis.

• In the case of technological development:

a) Receipt of patent application
b) Registration of cultivar.
c) Product registration with public agencies.
d) Proof of product trading.

In case of economic use of a finished product or reproductive material, the user must
provide proof that the accomplished access was enough to obtain the finished product or
reproductive material which is object of economic use, that is, that there was no research
or technological development activity after June 30, 2000.

39
Access to Associated Traditional Knowledge
Law n. 13.123/15 enhanced the concept of Access to Associated Traditional Knowl-
edge. The change also consisted in excluding the terms “sampling from genetic heritage
components” and “bioprospecting”, to highlight the purpose of research or techno-
logical development based on the associated traditional knowledge. The new wording
also clarifies that the associated traditional knowledge can be obtained from secondary
sources, such as publications, scientific articles, movies, and exhibitions.

PD n. 2186-16/01

Access to Associated Traditional Knowledge

Permission to obtain information about individual or collective knowledge

or practice associated with genetic heritage, from indigenous or local
communities, for the purposes of scientific research, bioprospecting or
technological development, aiming at its industrial application, among
other uses.

Law n. 13.123/15

Access to Associated Traditional Knowledge

Research or technological development conducted on traditional

knowledge associated with genetic heritage to allow or facilitate access
to genetic heritage, including that obtained through secondary sources,
such as trade shows, publications, inventories, movies, scientific articles,
records and other forms of systematization and recording of associated
traditional knowledge.

40
 Decree n. 8.772/16
Access to Associated Traditional Knowledge of identifiable origin is
conditioned to prior informed consent.

Access to Associated Traditional Knowledge of non-identifiable origin

does not depend on prior informed consent.

In-situ conditions
Law n. 13.123/15 enhances the concept of “in-situ conditions” of the CBD by incor-
porating the terms “own distinctive characteristics” and “spontaneous populations”
in its definition. The concept of spontaneous populations was also introduced in the
legislation for Access to Genetic Heritage by Law n. 13.123/15.

Law n. 13.123/15
In-situ conditions
Conditions under which genetic
CBD heritage exist in ecosystems and
In-situ conditions natural habitats and, in the case of
Conditions under domesticated or cultivated species,
which genetic in the surroundings where they have
resources exist in naturally developed their distinctive
ecosystems and properties, including the formation
natural habitats, of spontaneous populations.
and, in the case of
domesticated or
cultivated species,
in the surroundings Law n. 13.123/15
where they have Spontaneous population
developed their Population of species introduced in
distinctive agrarian the national territory, including those
characteristics. that have been domesticated and
are able to self-perpetuate in the
Brazilian ecosystems and habitats.

41
Provider and User
The term “provider” was used for the first time in the CBD to refer to a Country that
provides genetic resources. Law n. 13.123/15 introduced the concept of “provider of
associated traditional knowledge” to qualify people who hold associated traditional
knowledge, and the concept of “user” to qualify the person or entity that gets access
to genetic heritage or its associated traditional knowledge.

Law n. 13.123/15
Provider of Associated
CBD Traditional Knowledge
Genetic resources Indigenous population, traditional
provider country community or traditional farmer
A country that that holds and provides information
provides genetic on associated traditional knowledge
resources, to be to be accessed.
either collected
from in-situ sources,
including populations Law n. 13.123/15
of domesticated and
User
wild species,
Natural or legal person who gets
or obtained from
access to genetic heritage or associated
ex-situ sources,
traditional knowledge, or economically
which may have
benefits from finished products or
been originated in
reproductive materials resulting from
this country or not.
the access to genetic heritage or
associated traditional knowledge.

Shipping and Forwarding of Genetic Heritage

Law n. 13.123/15 distinguishes between the concepts of Shipping and Forwarding. Shipping
is the transfer of material to another country, with the purpose of access providing, under the
terms of a required Material Transfer Agreement – MTA. The responsibility for the sample is then
transferred to the recipient. In the case of Forwarding, although it is also a transfer to another
country, its purpose is to provide services as part of a Research or Technological Development
project, for example, product quality tests containing Brazilian genetic heritage components. In
this case, the responsibility for the sample falls upon the person that gets the access in Brazil.
42
43
 Shipping Forwarding

Transfer of genetic
Delivery of sample
heritage sample to an
containing genetic heritage
institution located outside
to a recipient abroad.
the Country.

Purpose: Purpose:
Acess Provision of services

Responsibility for the In this case, the responsibility for

sample transferred to the sample falls upon the person
recipient. who gets the access in Brazil.

MTA required MTA not required

Material Transfer Agreement (MTA)

Instrument signed between sender and recipient for overseas
shipping of one or more samples containing genetic heritage
components, either accessed or available for access, indicating,
when applicable, the occurrence of access to associated
traditional knowledge, and establishing the obligation of
benefit sharing, under the rules provided by this Law.

44
Decree n. 8.772/16
Data for filling out the Registration form to the Shipping of Genetic
Heritage Samples
The national natural or legal person must fill out the SisGen form, which requires:

• Identification:

a) Of sender.
b) Of the genetic heritage samples on the strictest possible taxonomic level.
c) Of the origin of samples to be shipped.
• Information on:

a) Type of sample and method of packaging.

b) Number of containers and volume or weight.
c) Name of overseas receiving institution, indicating a legal representative and
respective contact information.
d) Access activities outside the country, including information on purposes,
intended uses and the sector of application of the research or technological
development project.
• Material Transfer Agreement – MTA signed between the national natural or
legal person and the legal person abroad, including the obligation to comply with
requirements of Law n. 13.123/15, and providing that:

a) The MTA must be interpreted according to the Brazilian law, and, in the
event of a dispute, the competent court shall be in Brazil, with the possibility
of a mutually agreed arbitration between the parties.
b) The institution receiving genetic heritage samples will not be considered a
provider of genetic heritage.
c) The receiving institution will require third parties to sign an MTA with the
obligation to comply with the terms of Law n. 13.123/15, including the provi-
sion in Clause “a” of this Subsection.
• Prior informed consent expressly authorizing shipping in the case of genetic
heritage of local traditional and Creole variety, or of adapted or Creole breeds,
for access in non-agrarian activities, when applicable.

• A section to authorize or bar the transfer of a sample to third parties.

• Information on access to associated traditional knowledge, when applicable.

45
Finished Product and Intermediate Product
The concepts of “finished product” and “intermediate product” were introduced by Law
n. 13.123/15 in a very innovative way, to allow qualification of a product from a produc-
tion process that may result in benefit sharing. Under PD n. 2.186-16/01, there was no
differentiation of products, which could result in the payment of benefit sharing for both
intermediate and finished products. Under Law n. 13.123/15, manufacturers of interme-
diate products are exempt from benefit sharing payment. Among them are producers of
vegetable extracts, oils, process developers and producers of reproductive material who
sell exclusively to other producers in their production chain, for the multiplication of that
material. Producers of finished products need to submit a notification before they begin
the economic use of the product.

Intermediate Product
A product to be used in a productive chain, being aggregated to its production
process as an input, excipient or raw material, for the development of another
intermediate product or of a finished product.

Finished Product Main Elements of

A natural product that does not require any Value-adding for the
additional production processes, derived Product
from the access to genetic heritage or Elements which, when
associated traditional knowledge, in which present in a finished
the component of genetic heritage or product, turn out to
associated traditional knowledge is one of be essential for its
the main elements of added value, being functional characteristics
suitable for use by the final consumer, either or for the formation of
a natural or a legal person. market appeal.

Product Notification
A declaratory instrument that precedes economic activities with either finished
products or reproductive materials derived from access to genetic heritage or
associated traditional knowledge, in which the user declares to be compliant
with the requirements of this Law and indicates the benefit sharing modality,
when applicable, to be established in the benefit sharing agreement.

46
Decree n. 8.772/16
Product Notification
The user must notify about the finished product or the reproductive material
derived from access to genetic heritage or associated traditional knowledge after
the enforcement of Law n. 13.123/15.
The notification shall be delivered prior to the beginning of its economic use.
Economic use starts with the issuing of the first sale invoice of the finished
product or reproductive material.

Decree n. 8.772/16
Product Notification at SisGen
The user must fill out the SisGen electronic form, which requires:
• Identification of the applicant either a natural or legal person.
• Commercial identification of the finished product or reproductive material, with
sector of application.
• Information on whether the genetic heritage component or associated traditional
knowledge used in the finished product is essential for the creation of market appeal.
• Information on whether the genetic heritage component or associated
traditional knowledge used in the finished product is essential for the products’
functional characteristics.
• Estimated coverage of finished product or reproductive material’s manufacturing
and commercialization at local, regional, national and international levels.
• Registration number, or equivalent, of product or cultivar at the competent
agency, such as the Brazilian Health Regulatory Agency - Anvisa, the Ministry
of Agriculture, Livestock and Food Supply, or the Brazilian Environment and
Renewable Natural Resources Institute - Ibama.
• Number of receipt of intellectual property rights request application for the
product or cultivar at the Ministry of Agriculture, Livestock and Food Supply, at
INPI or in overseas offices, when applicable.
• Estimated start date of commercialization.
• Indication of benefit sharing modality.
• Forwarding of benefit sharing agreement, when applicable.
• Registration of Access to genetic heritage components or associated traditional
knowledge which have originated the finished product or reproductive material.
• Registration of Shipping of components that originated the finished product or
reproductive material, if any.
• Request for recognition of a legal case of confidentiality.
• Proof of classification into categories exempt from or not liable to paying
benefit sharing.

47
48
Verification Procedure

Decree n. 8.772/16
After the form for Notification about Finished Product is completed, SisGen
automatically issues a notification receipt. The notification receipt is the
required document to confirm that the user has provided all required
information and produces the following effects:
• Allows the economic use of the finished product or reproductive material.
• Starts the verification procedure.

Decree n. 8.772/16
Verification Procedure

The Administrative Verification Procedure shall be applicable in cases of:

• Registration of Access to genetic heritage or associated traditional
knowledge.
• Registration of shipping of genetic heritage sample.
• Notification about Finished Product or Reproductive Material.

During the verification period, the CGEN Executive Department must:

• Inform CGEN’s advisors about Registration and Notification.

• Forward information about the species to be accessed and the
Municipality of its location to members of competent sectoral chambers,
independent of any corresponding Records and other information
contained therein.
• Inform federal agencies for Protection of Native Populations and
Traditional Communities’ Rights about Registration of Access to associated
traditional knowledge.
• Be competent to identify, ex officio, irregularities in Registration or
Notification, and request correction of information or perform the
rectification of formal errors.

49
Key concepts for the agrarian sector
(Law n. 1 3.1 23/15)

Agrarian activities - activities for the producing, processing and

commercializing food, beverages, fibers, energy and planted forests.

Spontaneous population - population of species introduced in

the national territory, including those that have been domesticated
and are naturally able to self-perpetuate in the Brazilian ecosystems
and habitats.

Reproductive material - material of vegetal propagation or of

animal reproduction of any genus, species or cultivation, originating
from sexual or asexual reproduction.

Traditional farmer - natural person, including family farmer, who

uses local traditional or criollo varieties, or locally adapted or Creole
breeds, maintaining and preserving genetic diversity.

Local traditional or Creole variety - a variety originating

from species occurring at in-situ conditions or maintained at ex-situ
conditions, composed of a group of plants within a taxon on the
lowest known level, with genetic diversity developed or adapted by
indigenous populations, traditional communities or traditional farmers,
also by natural selection combined with human selection in the local
environment, and not substantially similar to commercial cultivars.

Locally adapted or Creole breed - breed originating from

species occurring at in-situ conditions or maintained at ex-situ conditions,
composed of a group of animals with genetic diversity developed or
adapted to a particular ecological niche and formed through natural
selection or through selection performed by indigenous populations,
traditional communities or traditional farmers.

50
CGEN - Genetic Heritage
Management Council
CGEN Structure

Law n. 13.123/15

The present Law establishes, under the scope of the Ministry of

Environment, the National Genetic Heritage Management Council
- CGEN, a collegiate organ of deliberative, normative, advisory and
appellate nature, responsible for coordinating the development and
the implementation of management policies for access to genetic
heritage and associated traditional knowledge, and for the sharing of
benefits, being composed of representatives of organisms and entities
of federal administration who hold the prerogative over distinct actions
mentioned in the wording of this Law, with maximum participation
of 60% (sixty percent) and minimum representation of civil society
members of 40% (forty percent), to assure parity between:

• Business Sector.
• Academic sector.
• Indigenous peoples, traditional communities
and traditional farmers.

Decree n. 8.772/16
CGEN shall operate through:

• The Board.
• Thematic Chambers.
• Sectoral Chambers.
• Executive Department.

51
CGEN Attributions

Law n. 13.123/15
CGEN Attributions
• Define: a) technical standards; b) guidelines and criteria for preparation and
fulfillment of benefit sharing agreement; c) criteria for the creation of a database
with information about genetic heritage and associated traditional knowledge.

• Follow up, in association with federal agencies or through accords with other
institutions, of activities such as: a) access to and shipping of samples contain-
ing genetic heritage components; b) access to associated traditional knowledge.

• Deliberate on: a) authorizations; b) accreditation of national institutions

maintaining ex-situ sample collections that contain genetic heritage components;
c) accreditation of national institutions for the creation and maintenance of
databasis.

• Attest the regularity of access to genetic heritage or associated traditional

knowledge.

• Register the notification of finished product or reproductive material and the

submission of a benefit sharing agreement.

• Promote debates and public consultations on the topics of the Law.

• Operate as a higher instance of appeal in relation to the decision of an accred-

ited institution and to acts resulting from the application of this Law.

• Define guidelines for the use of financial resources in the National Fund for
Benefit Sharing - FNRB.

• Create and maintain a database with: a) records of access to genetic heritage

or associated traditional knowledge and records of shipping activities; b)
authorizations for access to genetic heritage or associated traditional knowledge
and shipping licenses; c) instruments and terms of material transfer; d) ex-situ
collections of accredited institutions that contain samples of genetic heritage
components; e) records of notifications of finished product or reproductive
material; f) benefit sharing agreements; g) access regularity certificates.

• Inform federal agencies for Protection of Indigenous Populations and Traditional

Communities’ Rights of an entry for registration of access to associated traditional
knowledge.

• Approve their bylaws.

52
Benefit Sharing
Concepts

PD n. 2.1 86-1 6/01

Benefit Sharing
Benefits resulting from the economic use of a product or process developed
from a sample of a genetic heritage component and its associated traditional
knowledge, obtained by either a national or an overseas institution, will be
shared in a fair and equitable manner between the contracting parties, as
provided by regulations and applicable legislation.

Law n. 1 3.123/15
Benefit Sharing
Benefits resulting from the economic use of finished products or reproductive
material obtained through access to the genetic heritage of species found at
in-situ conditions, or to associated traditional knowledge, even if produced
outside the country, will be fairly and equitably distributed, and, in the case of
the finished product, the genetic heritage or associated traditional knowledge
component must be one of the main elements of value-adding, according to
the provisions of this Law.

Sharing of benefits shall be applied to the finished product and to the last link
of the production chain, in the case of reproductive material, while all other
links will remain exempt.

If a single finished product or reproductive material is the result of distinct accesses,

these will not be cumulatively considered in the calculation of benefit sharing.

The terms “finished product”, “reproductive material” and “main element of value-
adding” have been included in the concept of “benefit sharing”. It is interesting to notice
that the two legislations consider the participation of overseas institutions, however, in
the PD, this is limited to the collection of a sample by a foreign institution, while Law n.
13.123/15 considers production outside the Country.

53
Benefit Sharing Modalities

Sharing of Benefits arising from the economic use of a finished product or reproductive
material derived from access to genetic heritage components or to associated traditional
knowledge may occur in monetary and non-monetary modalities.

Non-monetary BS

Development and Development and

Implementation Implementation of
of Projects for Projects for protection and
conservation or preservation of knowledge,
sustainable use of innovations or traditional
biodiversity. populations practices.

Preferably in the area of occurrence of the species at

in-situ condition or at the location of sample collection.

Technology transfer.

Availability of products in public domain, without intellectual

property rights or technological restrictions.

Free-of-charge licensing of products.

Capacitation of human resources in related topics.

Free distribution of products in programs of social interest.

54
 Monetary BS

1% of the annual net Possibility of reduction

revenue from the economic from 1% down
use of a Finished Product or to 0.1% through
Reproductive Material. Sectoral Agreement.

Mandatory for the sharing of benefits

from Associated Traditional Knowledge
of Non-Identifiable Origin.

Liability of Benefit Sharing Payment

Who should pay Benefit Sharing?

Only the manufacturer of the finished product or the producer of the

reproductive material will be subject to benefit sharing payment, irrespective
of who has formerly accessed it.

55
Exemption of Benefit Sharing Payment

Who is not liable to pay Benefit Sharing?

• Manufacturers of intermediate products.

• Developers of processes derived from access to genetic heritage or associated traditional
knowledge, throughout its production chain.
• Operations of licensing, transfer or permission to use any form of intellectual property
right over finished products, processes or reproductive materials derived from the access
to genetic heritage or associated traditional knowledge by third parties.
• Microenterprises, small businesses, and individual microentrepreneurs, as stated in
Supplementary Law n. 123, of December 14, 2006.
• Traditional farmers and their cooperatives, with annual gross revenue equal to or under
the maximum limit established in subsection II, Sect. 3 of Supplementary Law n. 123 of
December 14, 2006.
• Initiatives of economic use of finished products or reproductive
material derived from the access to genetic heritage of
species introduced into the national territory by human
action, even when domesticated, except: I - those
that form spontaneous populations and have
acquired distinctive characteristics in the Country;
and II - local traditional or Creole varieties or
locally adapted or Creole breeds.

Benefit sharing from Foreign Products with

Brazilian Genetic Heritage Components

Who should pay Benefit Sharing for foreign products with Brazilian Genetic
Heritage Components?

The importer, subsidiary, controlled company, affiliate, associated company or commer-

cial representative of the foreign manufacturer, in national territory or in the territory of
countries with which Brazil has an agreement for this purpose, will be jointly liable with
the manufacturer of the finished product or reproductive material to the payment of
benefit sharing.

56
57
Benefit Sharing from Agrarian Products

Benefits arising from the economic use of a product derived from the access to
genetic heritage or associated traditional knowledge for agrarian activities will
be shared based on the commercialization of the reproductive material,
even when the access or economic use is performed by a natural or legal
person, subsidiary, controlled or colligated company, contractor, outsourced
company or associated company.

Benefit sharing from agrarian products shall be applied to the last link
of the production chain of reproductive material, while the other links
remain exempt.

In case of economic use of reproductive material obtained through access to

genetic heritage or associated traditional knowledge for purposes of agrarian
activities and exclusively intended for the generation of finished products
in production chains that do not involve agrarian activities, benefit
sharing is only applicable to the economic use of the finished product.

Sectoral Agreements

To ensure competitiveness in the sector, the Federal Union may, if requested

and according to the norms, sign a sectoral agreement to allow reduction
of monetary benefit sharing down to 0.1% of the annual net revenue
from the economic use of finished products or reproductive materials
derived from the access to genetic heritage or associated traditional
knowledge of non-identifiable origin.

To support the signing of a sectoral agreement, official agencies for protection

of indigenous populations and traditional communities’ rights can be heard,
under the terms of the regulation.

58
Benefit Sharing Agreement

The Parties

• In the case of economic use of a finished product or reproductive

material derived from access to Genetic Heritage - GH or Associated
Traditional Knowledge - ATK of non-identifiable origin:

a) The Federal Union, represented by the Ministry of Environment.

b) Those who make economic use of a finished product or reproductive
material originating from access to GH or ATK of non-identifiable origin.

• In the case of economic use of a finished product or reproductive

material derived from access to Genetic Heritage - GH or Associated
Traditional Knowledge - ATK of identifiable origin:

a) The provider of associated traditional knowledge.

b) Those who make economic use of a finished product or reproductive
material originating from the Access to Associated Traditional Knowledge.

Payment of Benefit sharing from the economic use of a finished product or

reproductive material derived from the Access to Associated Traditional
Knowledge exempts the user from the sharing of benefits related to
genetic heritage.

Benefit Sharing of ATK of Identifiable Origin

When a finished product or reproductive material derives from Access to

Associated Traditional Knowledge of identifiable origin, the provider of
associated traditional knowledge will be entitled to receive benefits
through the establishment of a Benefit Sharing Agreement.

59
 Benefit Sharing in Collective ATK

Benefit sharing with other holders of the same associated traditional

knowledge will follow the monetary modality, to be accomplished
through the National Fund for Benefit Sharing - FNRB (irrespective of
the number of holders).

The amount due by users to the sharing of benefits, to be deposited in

the National Fund for Benefit Sharing - FNRB, corresponds to half of
that provided for in Sect. 20 of Law 13.123/15, or as defined by
sectoral agreement (respectively, 1% or down to 0.1%).

(Minimum) Provisions of a Benefit Sharing Agreement

• Product/object of economic use.

• Duration.
• Modality of benefit sharing.
• Rights and liabilities of the parties.
• Intellectual property rights.
• Termination.
• Penalties.
• Jurisdiction in Brazilian Courts.

60
Administrative Sanctions
of Law n. 13.123/15

Administrative sanctions (cumulative)

Administrative violations against Genetic Heritage or Associated Traditional
Knowledge will be punished with the following sanctions:
• Warning.
• Fine.
• Seizure:
a) Of samples containing accessed genetic heritage components.
b) Of instruments used to obtain or process accessed genetic heritage or
associated traditional knowledge.
c) Of products derived from access to genetic heritage or associated
traditional knowledge.
d) Of products derived from access to information on associated traditional
knowledge.
• Suspension of manufacturing and sales of the finished product or of the
reproductive material originating from the access to genetic heritage or
associated traditional knowledge until regularization.
• Embargo of the specific activity related to the violation.
• Total or partial interdiction of establishment, activity or enterprise.
• Suspension of certificates or permits provided under this Law.
• Cancellation of certificates or permits provided under this Law.

Competent authorities must observe:

• The severity of the fact.
• The offender’s background concerning compliance with the laws on genetic
heritage and associated traditional knowledge.
• Recidivism
• The offender’s economic situation, if a fine is applicable.

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62
 Fines
I • From BRL 1,000,00 (one thousand reals) to BRL 100,000,00 (a hundred
thousand reals), for violations by a natural person.
II • From BRL 10.000,00 (ten thousand reals) to BRL 10,000,000.00 (ten million
reals), for violations by a legal entity or with its participation.

National Fund for Benefit

Sharing - FNRB
FNRB Revenues
• Appropriations consigned in the Annual Budget Law and its additional credits.
• Donations.
• Income from the payment of administrative fines applied in virtue of the breach
of this Law.
• Financial resources of external origin arising from contracts, agreements or
partnerships, especially destined for the purposes of the Fund.
• Contributions from genetic heritage or associated traditional knowledge users
for the Benefit Sharing National Program.
• Amounts originating from the sharing of benefits.
• Other revenues that may be apportioned.

Applications of FNRB Resources

Resources deposited at the FNRB resulting from the economic use of finished
products or reproductive materials derived from the access to ATK will be
exclusively destined to benefit ATK holders.

Resources deposited at the FNRB resulting from the economic use of finished
products or reproductive materials derived from the access to GH at ex-situ
collections will be partially destined to benefit these collections.

63
National Benefit Sharing
Program - PNRB

Purposes:
• Conservation of biological diversity.
• Recovery, creation and maintenance of ex-situ collections from GH samples.
• Prospecting and training of human resources related with the use and the
conservation of genetic heritage or associated traditional knowledge.
• Protection, promotion of the use, and valorization of ATK.
• Implementation and development of activities for the sustainable use of
biological diversity, its conservation and the sharing of benefits.
• Promotion of R&D related to GH and ATK.
• GH Survey and inventory, considering the location and the level of variation
in existing populations - including those of potential use - and, if possible,
assessing any threats on them.
• Support the efforts of traditional communities towards sustainable
management and conservation of genetic heritage.
• Conservation of wild plants.
• Creation of an efficient and sustainable ex-situ and in-situ conservation
system and development and transfer of technologies for this purpose, aiming
to improve the sustainable use of GH.
• Monitoring and maintenance of the viability, the degree of variation and the
genetic integrity of genetic heritage collections.
• Adoption of measures to minimize or eliminate threats on GH.
• Development and maintenance of several cultivation systems to favor a
sustainable use of genetic heritage.
• Development and implementation of the Plans for the Sustainable
Development of Traditional Populations or Communities.
• Other actions related to the access to genetic heritage and associated
traditional knowledge, as per regulation in force.

64
Adequacy and
Regularization of Activities

Deadlines for Authorization or Regularization

Request for authorization or regularization of access and shipping of
genetic heritage or associated traditional knowledge still under consideration
on the date of entry into force of Law n. 3.123/15 should be redrafted by
the user as a request for Registration or Authorization for access or shipping,
as the case may be (one year, counting from the date on which
registration admission was started by CGEN).

Terms and Conditions for Adaptation

Adaptation to the terms of this Law, within one year, counting from the
date on which registration admission was started by CGEN, is mandatory
to the user that has performed the following activities, as of June 30, 2000,
as provided by PD n. 2.186-16/01:

• Access to genetic heritage or associated traditional knowledge.

• Economic use of a product or reproductive material derived or a legal person
from the access to genetic heritage or to associated traditional knowledge.

Steps for Authorization and Regularization

• Register access to genetic heritage or to associated traditional knowledge.
• Notify on the finished product or reproductive material for economic
use, under the terms of Law n. 13.123/15.
• Share benefits arising from economic use implemented as of the date
of entry into force of Law n. 13.123/15, in accordance with Chapter V, except
when it has already been done under the provision of PD n. 2.186-16/01.

65
 Deadlines and conditions for Regularization
with Term of Commitment
Regularization (with the signing of a Term of Commitment) under the
terms of this Law and within one (1) year counting from the date
on which perpetuate Registration admission was started by CGEN
is mandatory to the user who, between June 30, 2000 and the date
of entry into force of Law n. 13.123/15, performed the following
activities in disagreement with the legislation in force at the time:

• Access to genetic heritage or associated traditional knowledge.

• Access to and economic use of a product or process derived from genetic
heritage or associated traditional knowledge, under PD n. 2.186-16/01.
• Overseas Shipping of genetic heritage samples.
• Dissemination, transmission or retransmission of data integrating or
constituting associated traditional knowledge.

Exemption for Research

In the event of access to genetic heritage or to associated traditional
knowledge solely for purposes of scientific research, the user will
be excused from signing the Term of Commitment, as registration or
authorization for the activity, depending on the case, should be enough
for regularization.

Registration and Authorization mentioned above have extinguished

the liability to the administrative sanctions provided by PD n.
2.186-16/01 and specified in Sect. 15 and 20 of Decree n. 5.459/05,
provided that the violation had been performed until the day before the
date of entry into force of Law n. 13.123/15.

66
67
 Term of Commitment

The Term of Commitment shall provide, as appropriate:

• The registration data or authorization of access or shipping of GH or ATK.
• The notification of product or process originating from access to GH or ATK,
as provided by PD n. 2.186-16/01.
• The sharing of benefits, relative to the time during which a product
developed after June 30, 2000, originating from access to GH or ATK, was
made available in the market, to the limit of 5 years prior to the execution of
the Term of Commitment, not considering the period of processing at CGEn.

The execution of the Term of Commitment will suspend, in all cases:

• The application of administrative sanctions under PD n. 2.186-16/01
and specified in Sect. 16 to 19 and 21 to 24 of Decree n. 5.459/05, provided
that the violation had been performed until the day before the date of entry
into force of Law n. 13.123/15.
• The enforceability of sanctions based on Provisional Decree n.
2.186-16/01, and in Sect. 16 to 19 and 21 to 24 of Decree n. 5.459/05.

Intellectual Property
The applicant of a patent request already filed at the National
Institute of Industrial Property - INPI, during the enforcement of
Provisional Decree n. 2.186-16/01, must submit proof of registration
or authorization for regularization.

After made available by SisGen, the granting of intellectual

property rights by the competent agency over the finished product
or reproductive material obtained from the access to genetic
heritage or associated traditional knowledge will be subject to
registration or authorization.

68
General Guidelines
Application of Law n. 13.123/15

Access to genetic heritage.

Access to Associated Traditional Knowledge.

Overseas Shipping of genetic heritage samples (conditioned

to execution of MTA).

Economic use of finished product derived from access

to genetic heritage or associated traditional knowledge
performed after the lapse of Law n. 13.123/15.

Economic use of reproductive material derived from access

to genetic heritage or associated traditional knowledge,
performed after the lapse of Law n. 13.123/15.

Access to genetic heritage or associated traditional knowledge

by a foreign natural person is prohibited.

Non-application of Law n. 13.123/15

Human genetic heritage

Access to genetic heritage and associated traditional knowledge

for practices that may be harmful to the environment, to cultural
reproduction and to human health, and for the development of
biological and chemical weapons is prohibited.

69
General Guidelines per type of activity
General Guidelines for Research Activity with
Brazilian Genetic Heritage Components

Research with brazilian genetic heritage

Registration of access activity at SisGen

Indication of genetic heritage origin

(in-situ, ex-situ, in silico)

Automatic receipt issued by SisGen

70
General guidelines for Research activity with
Shipping of Brazilian Genetic Heritage Components

Research with brazilian genetic heritage

Registration of access activity at SisGen

Indication genetic heritage origin

(in-situ, ex-situ, in silico)

Execution of the material transfer agreement (MTA)

Automatic receipt issued by SisGen

Shipping of the brazilian genetic heritage

with the MTA and the SisGen receipt

71
General guidelines for Research activity
with Forwarding of Brazilian Genetic Heritage
Components

Research with brazilian genetic heritage

Register of access activity at SisGen

Indication of genetic heritage origin

(in-situ, ex-situ, in silico)

Automatic receipt issued by SisGen

Register of brazilian genetic heritage shipping

Execution of legal instrument to be delivered with

the sample of brazilian genetic heritage

72
General guidelines for Technological
Development activity without access
to Associated Traditional Knowledge

Technological development without associated

traditional knowledge

Register of research and development activity at SisGen,

with the automatic issuance of registration receipt

Finished product or reproductive material derived

from brazilian genetic heritage

Notification prior to economic use with automatic

issuance of notification receipt

Is genetic heritage a key element of value-adding

to the product?

In case it is a key element of value-adding: select

benefit sharing modality (monetary or non-monetary).
If it is not a key element of value-adding, there will be
no benefit sharing

Non-monetary BS = 0.75% of net revenue for projects

or
Monetary BS = 1% of net revenue to the FNRB

73
General Guidelines for Research and/or
Technological Development with Associated
Traditional Knowledge of Identifiable Origin

Research and/or technological development with

associated traditional knowledge.

Prior-to-access informed permit (identifiable ATK).

Register of research activity with ATK at SisGen with

automatic issuance of registration receipt.

Finished product or reproductive material developed from

the Brazilian genetic heritage.

Notification prior to economic use, with automatic

issuance of notification receipt.

Is genetic heritage or associated traditional knowledge

a key element of value-adding to the product?

In case it is a key element of value-adding: preparation

and signature of a benefit sharing agreement, with choice
of benefit sharing modality (monetary or non-monetary).
If it is not a key element of value-adding, there will be no
benefit sharing obligation.

74
General Guidelines for Research and/or
Technological Development Activity with
Access to Associated Traditional Knowledge
of Non-identifiable Origin

Technological development with associated traditional

knowledge of non-identifiable origin.

Register of research and development activity at SisGen,

with automatic issuance of registration receipt.

Finished product or reproductive material derived from

brazilian genetic heritage.

Notification prior to economic use, with automatic

issuance of notification receipt.

Is genetic heritage a key element of

value-adding to the product?

In case it is a key element of value-adding:

Monetary benefit sharing
(1% of Net Revenue to the FNBR).
If it is not a key element of value-adding, there will be
no benefit sharing obligation.

75
76
SisGen Registration Guidelines
The guidelines for registration at SisGen have been taken from the SisGen User Guide.

SisGen can be accessed via website: https://sisgen.gov.br. You must be a registered

user (Cadastro do Usuário) and install the security module (Módulo de Segurança) to
access SisGen.

SisGen Menus

77
Filling the Form
Form fields must be filled in following the order in which they appear, once they are
dynamic and adapt to the entered information. At the end of the form, the ‘Register’
option will complete the process and move to the next segment of the flow for each
type of registration.

At the end of the forms for registration of access and shipping, for notification on finished
product or reproductive material, and for the accreditation of ex-situ collection, you will
have the option to save a draft of the form being filled.

Confidentiality of Information
User Registrations are confidential, as they contain highly sensitive personal information,
under the terms of Law n. 12.527 of November 18, 2011.

As for other registers, all information is public, except if also classified as personal
information or when confidentiality is requested by the user, as provided by in current
legislation.

Fields subject to confidentiality requests are indicated by an open padlock icon by the
side of form field.

Registration Receipt and Certificate

After registration is complete (access, shipping or notification about finished product or
reproductive material), SisGen will automatically issue the corresponding receipt.

The receipt may be issued at any time while registration is active. To do this, select ‘Aces-
sos Cadastrados’, ‘Remessas Cadastradas’ or ‘Notificações Cadastradas’ on the menu.

78
User Registration

79
Filling out the ‘User Registration’ Form:

80
Relationship with a national institution depends on approval by the pertinent legal
representative. The relationship with institutions may be later modified on ‘Alterar meu
cadastro’.

Accept the “Termos de Uso e Declarações’ on ‘Cadastro de Usuário”.

SisGen will display a note informing that registration has been successfully completed
and forward a message to the registered email containing SisGen login password.

Institution Registration
To register an institution at SisGen, select ‘Cadastrar Instituição’ on the menu ‘Dados
Cadastrais’ and fill out the registration form for the institution. After saving the entered
information, registration data will be sent for validation by CGEN’s Executive Department.

81
Legal Representative

Inform tax-payer number - CPF - of appointed legal representative. In case this CPF has
already been entered at SisGen, the system will recognize it and automatically inform
you by e-mail. If the CPF is not registered yet, inform name and email address of the
legal representative, and the system will issue an alert of appointment. It is possible to
appoint more than one legal representative, but validation will be individual. Therefore,
each appointed legal representative must be empowered to separately represent the
institution at SisGen.

After properly filling out and saving the form, the registration of the institution will be
sent for validation by CGEN’s Executive Department.

82
83
During the process of validation, data on the institution and the suitability of appointed
legal representative(s) will be reviewed. Even if more than one legal representative is
appointed, validation will be individual, and each legal representative will have powers to
separately represent the institution at SisGen.

In the event of inconsistency in the institution’s data or if at least one legal representative
has not been appointed, the registration of the institution will not be validated. In this
case, the legal representative of the institution should contact the administration of
SisGen to regularize the institution registration.

Access and Forwarding Registration

To register an access activity, select the option ‘Novo Cadastro’ on SisGen’s menu
‘Atividade de Acesso’ and fill out the form.

Type of Use: Identify the institution to which the person responsible for access activities
is connected. If you are responsible for the activities as a natural person, not connected
to any institution, please select ‘Independente’. Note: A foreign natural person can not
register as ‘Independente’.

Object of Access: Please inform if the activity to be registered refers to access to genetic
heritage, to associated traditional knowledge or both.
84
Was access performed before Nov 17, 2015 or was access authorization obtained before
Nov 17, 2015? Please inform if access was granted or if authorization for access was
obtained before Law n. 13.123/15 came into force.

For more specific details, please check possible situations:

1 Access initiated after Nov 17, 2015, with no authorization request under review
during the validity of Provisional Decree n. 2.186-16/01 - select option ‘Não, sem so-
licitação de autorização em tramitação’. In the following field, ‘Finalidade do Acesso’,
inform if the purpose of the access activity being registered is ‘Pesquisa (Research)’, ‘De-
senvolvimento Tecnológico (Technological Development)’ or both, as provided by Law n.
13.123/15. Then, move on to ‘Vínculo com acesso ou remessa anterior’.

2 Access initiated after Nov 17, 2015, with authorization request under review during
the validity of Provisional Decree n. 2.186-16/01 - select option ‘Não, com solicitação de
autorização em tramitação na vigência da Medida Provisória n. 2 .186-16/01. Check-
ing this option will enable fields ‘Número do Processo’ – in which the corresponding
number of the administrative process under verification must be entered, and ‘Finalidade
do Acesso’ – in which the purpose of the access activity being registered is informed
by checking ‘Pesquisa’, ‘Desenvolvimento Tecnológico’, or both, as provided by Law n.
13.123/15. Then, move on to ‘Vínculo com acesso ou remessa anterior’.

3 Access performed before Nov 17, 2015, with Prior Access Authorization, or authori-
zation for access prior to Nov 17, 2015, even if activities had not started before that date
- select ‘Sim’ in the field ‘O acesso foi realizado antes de 17/11/2015 ou obteve autori-
zação de acesso antes de 17/11/2015?’ When you do that, the system enables the field
‘Tem autorização de acesso?’, in which you should select ‘Sim - Autorização Prévia’. In
the following fields, select the institution that granted access authorization and enter the
corresponding number of the administrative process under which the authorization was
granted. SisGen will automatically complete the remaining form fields.

85
The system will also automatically complete the field ‘Possui produtos oriundos deste
acesso explorados economicamente?’ and, in case of (Yes), the full informed list of
products developed under the corresponding administrative process will also be filled in.

If you have developed products which have not been pre-registered when access autho-
rization was issued, it is possible to register them if this permit is still within its valid dates.

86
4 Access prior to Nov 17, 2015, with Regularization of Access Authorization (Resolu-
tion n. 35, of April 27, 2011) - If access activity started before November 17, 2015, and
has obtained access authorization in the course of the regularization provided by Resolu-
tion 35 of 2011, select ‘Sim’ in the field ‘O acesso foi realizado antes de 17/11/2015 ou
obteve autorização de acesso antes de 17/11/2015?’ When you do this, the system will
enable the field ‘Tem autorização de acesso?’, for which you should select ‘Sim - Regu-
larização’. In the next fields, select the institution that granted the access authorization
and enter the corresponding number of the administrative process under which the au-
thorization was granted. SisGen will automatically complete the remaining form fields.

87
88
The system will also automatically complete the field ‘Possui produtos oriundos deste
acesso explorados economicamente?’ and, in case of (Yes), the full informed list of
products developed under the corresponding administrative process will also be filled in.
89
After the products section, it is also mandatory to inform if you wish to adhere to the
regularization provided by Sect. 38 of Law n. 13.123/15. If you answer yes, you will have
to submit a Term of Commitment.

5 Access performed prior to Nov 17, 2015, with authorization request under review
during the validity of Provisional Decree 2.186-16/01 - In case of access activity started
before November 17, 2015 and with a request for access authorization in the course of
regularization under Resolution 35 of 2011, which was in progress during the validity of
Provisional Decree n. 2.186-16/01, select ‘Sim’ in the field ‘O acesso foi realizado antes
de 17/11/2015 ou obteve autorização de acesso antes de 17/11/2015?’ When you do
this, the system will enable the field ‘Tem autorização de acesso?’, in which you must
select ‘Não – Com solicitação em tramitação no CGEN antes de 17/11/2015’. In the
90
next fields, select the institution in which the request for access authorization is being
processed and enter the number of the respective administrative process. SisGen will au-
tomatically complete the remaining fields of the form, except the fields specified below
(highlighted in the image).

Inform if you want to share benefits under Provisional Decree n. 2.186-16/01, if you
have already submitted a Contract for Use of Genetic Heritage and Benefit Sharing -
CURB or a Project of Benefit Sharing to CGEN. If this is the case, SisGen will present
the CURB or Project of Benefit Sharing and the products informed in the process. New
products that have not yet been reported to CGEN should be subject to notification, as
provided by Law n. 13.123/15.

If you choose not to share benefits under the terms in Provisional Decree n. 2.186-
16/01, the products resulting from this access shall be subject to notification, under Law
n. 13.123/15.
91
It is also necessary to submit the Term of Commitment to complete the registration.

Check the information filled in by the system and complete the registration. In case you
identify any inconsistency, please contact CGEN’s Executive Department.

6 Access before November 17, 2015, with no authorization request under review - If
the access activity has started before Nov. 17, 2015, without the initiation of a regulari-
zation process for the activity, as provided by Resolution n. 35 of 2011, select ‘Sim’ in
the field ‘O acesso foi realizado antes de 17/11/2015 ou obteve autorização de acesso
antes de 17/11/2015?’ When you do this, the system will enable the field ‘Tem autori-
zação de acesso?’, in which you should select ‘Não – Sem solicitação em tramitação no
CGEN. Next, please, inform access purpose.

92
Connection with Previous Access or Shipping Activities

Activity of Access to Genetic Heritage

and Associated Traditional Knowledge

93
About Accessed Genetic Heritage Component
Inform if access to genetic heritage will occur in an area indispensable for national secu-
rity (border strip or oceanic islands) and/or in Brazilian jurisdictional waters, continental
shelf and exclusive economic zone.

94
If the access is to be carried out in an area indispensable for national security (border
strip or oceanic islands) and/or inBrazilian jurisdictional waters, continental shelf and
exclusive economic zone, the system will enable the field ‘Este cadastro necessita de
autorização prévia de acesso?’.

In case registration requires prior authorization from the Navy Command, it will be
necessary to provide information relating to the expedition for obtaining the material.

95
In case registration does not require prior authorization, the user must declare that the
activity does not fit the requirements of Subsections I, II and III of Sect. 27 of Decree n.
8.772 of 2016, as shown in the image below.

96
Taxonomic identification of genetic heritage component

About the Genetic Heritage Origin

Inform the origin of genetic heritage component, from the following options:

In-situ: if it has been obtained at in-situ conditions.

Ex-situ: if it has been obtained at ex-situ conditions.
In silico: if it has been obtained at in silico conditions.
Intermediate product

97
98
99
100
101
About Associated Traditional Knowledge
Enter information about accessed associated traditional knowledge. It is possible to add
several registers of different knowledges, according to the activity being registered.

102
Identification of Associated Traditional Knowledge
Source of acquisition of Associated Traditional Knowledge: Indicate if the associated
traditional knowledge has an identifiable origin obtained from primary sources (directly
from provider) or secondary sources (publications, such as books, journals, academic
articles, among other sources), or if the associated traditional knowledge is of non-
identifiable origin.
103
It is only possible to register access to Associated Traditional Knowledge of Non-Identifiable
Origin to ATK that have been acknowledged as such by CGEN.

About the Provider - Traditional Knowledge of Identifiable Origin

In cases of traditional knowledge of identifiable origin, accessed both from primary and
secondary sources, it is necessary add information on the provider of the associated
traditional knowledge, as well as on its representatives.

104
105
106
Partnership with a National Institution

If the activity is carried out in collaboration with another national institution, enter data on
the partnership with this institution in this section. You can add more than one institution.

107
If the registration requests prior authorization from the Council of National Defense or
from the Navy Command, documents about the board of shareholders of the partner
institution that has a foreign person as controlling shareholder or partner must be
submitted for the identification of the natural persons that hold the title of partners or
controllers.

108
Partnership with an Overseas-based Institution
If the activity is carried out in partnership with an overseas institution, enter data on the
partnership with the institution in this section. You can add more than one institution.

If the registration requests prior authorization from the Council of National Defense or
from the Navy Command, documents about the board of shareholders of the partner
institution must be submitted for the identification of the natural persons that hold the
title of partner or controller.
109
110
Results

In this section, it is possible to add data on results obtained from access activity. Before
registration is fully completed, you can only add results relating to:

1 Identification of substance originating from the metabolism of microorganism identical

to an existing fossil substance.

111
2 Application for intellectual property rights.

3 Patent licensing.

4 Commercialization of intermediate product.

5 Communication of results, whether partial or final, in scientific or communication media.

112
6 Other findings.

Forwarding Registration

For the registration of the forwarding of a sample containing genetic heritage components
for the provision of services abroad, as part of research or technological development,
SisGen provides a section within the access registration form. You can register more than
one forwarding activity.

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About Genetic Heritage

Specification of Activities
Specify activities performed abroad with samples transferred by forwarding. Please,
inform if the forwarding of the sample is intended for genetic sequencing.

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Overseas Recipient Institution

Identify Overseas Recipient Institution, including contact information and identification

of a legal representative.

Legal Instrument

Present the legal instrument provided for in § 6 of Sect. 24 of Decree n. 8.772/16. The
legal instrument is not mandatory in cases of forwarding for genetic sequencing, as
provided for in § 7 of Sect. 24 of Decree n. 8.772/16.

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Shipping Registration
For Shipping Registration, select the option ‘Novo Cadastro’ on SisGen’s menu ‘Remessa’,
and fill out the form.

Type of User and the Responsible for Registration

Type of User: Identify the institution to which the person responsible for the activities of
access is connected. If you are responsible for the activities as a natural person and not
connected to any institution, please select ‘Independente’.

Person Responsible for Registration: If you wish that other users view and edit the access
records, add them as people responsible for registration by entering the users’ tax-payer
numbers - CPF.

The user must be registered in SisGen and be enabled by the Legal Representative to be
added as the person responsible for a registration.

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Object of Registration

Was this shipping performed before Nov 17, 2015?: Please inform if the shipping was
performed before Law n. 13.123 of 2015 took effect.

If the shipping had not been performed before Nov 17, 2015, please select option ‘Não’
and continue filling out the form (from Vínculo com cadastro de acesso).

If the shipping had been performed before Nov 17, 2015, please inform if there is an
authorization to regularize the shipping, granted as provided for in Resolution 35 of 2011.

If you do not have a shipping authorization, submit the ‘Term of Commitment’ and move
on to Vínculo com cadastro de acesso.

Users who regularized their access activities during the validity of Provisional Decree n.
186-16 of 2001 are entitled to adhere to the regularization provided for in Sect. 38 of
Law n. 13.123/15 of 2015. If you are not interested in adhering to the regularization
provided for in Sect. 38 of Law n. 13.123 of 2015, please select the option ‘Não’ and
move on to ‘Vínculo com cadastro de acesso’.

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If you are interested in adhering to the regularization provided for in Sect. 38 of Law
n. 13.123, of 2015, please select the option ‘Sim’ and submit the ‘Term of Commit-
ment’. If there is a connection with a previously completed access registration, please
inform as per instructions in ‘Vínculo com cadastro de Acesso’.

Check the information filled in by the system and complete the registration.

Connection with Previous Access Registration

Connection with Previous Access Registration: Please inform if the shipping to be reg-
istered is connected to any previous access registrations. If so, please inform the corre-
sponding number of the access registration, and if the user is one of those responsible for
the access registration, the system will automatically retrieve the information about the
accessed component of genetic heritage.

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Material Transfer Agreement

Overseas Access Activities

About the Genetic Heritage Component to be Shipped

Add information on the species whose genetic heritage will be the subject of shipping.
It is possible to add several registers of different species, according to the activity that
is being registered.
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If access does not occur in an area indispensable for
the national security (border strip or oceanic islands)
and/or Brazilian in jurisdictional waters, continen-
tal shelf, and exclusive economic zone, move on to
‘Identificação taxonômica do patrimônio genético’.

If the access is to be carried out in an area indispen-

sable for national security (border strip or oceanic
islands) and/or in Brazilian jurisdictional waters, con-
tinental shelf and exclusive economic zone, the sys-
tem will enable the field ‘Este cadastro necessita de
autorização prévia de acesso?’ Inform if the registra-
tion requires prior authorization or if you already have
a prior authorization that can be used for registration
(pursuant to § 6 of Sect. 27 of Decree n. 8.772/16),
or if it does not require prior authorization.

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In case registration does not require prior authorization, it is mandatory for the user to
declare that the activity does not fit the requirements of Subsections I, II and III of Sect.
27 of Decree n. 8.772/16, as shown in image below.

Taxonomic Identification of Genetic Heritage Component

Type of Component: Identify in which group of living beings the species fits. If it is not
possible to identify the species at the time of registration, select the option ‘Impossibili-
dade de identificação’. In case of impossibility of identification, it is mandatory to submit
a justification on the impossibility of identification.

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Scientific name: Enter the scientific name of the species (genus and specific epithet).
You can click ‘Clique aqui para pesquisar’ to search for scientific names in the SisGen
database; after selecting the species from the database, the system will automatically fill
in the fields relating to the taxonomic classification of the species.

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About Genetic Heritage Origin

Inform Genetic Heritage origin.

1 In-situ: if it has been obtained at in-situ conditions.

2 Ex-situ - Biological Collection: if it has been obtained from a biological collection, as

defined in the Normative Instruction - IBAMA n. 160/07:

”collection of sample biological material constituted with the purpose of generating and
subsidizing scientific or technological research, as well as promoting culture, education
and the preservation of the environment. Exceptions are the living collections sheltered
by zoological gardens, breeding grounds, aquariums, oceanariums, animal centers, sorting
centers, animal rehabilitation or recovery, as well as plant nurseries”.
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3 Ex-situ - Commerce: if it has been obtained in a commercial establishment, without
possibility of source identification.

4 Ex-situ - Cultivation site or Breeding Ground: if it has been obtained in cultivation

sites or breeding grounds.

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5 Ex-situ - Other ex-situ collections: if it has been obtained from other ex-situ collec-
tions that do not fit the definition of biological collection provided by Ibama’s Normative
Instruction n. 160/07 (seen above).

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6 In silico: if it has been obtained at in silico conditions.

7 Intermediate product: if it has been obtained directly in the form of an intermediate

product developed in the context of another access activity.

In case the intermediate product does not derive from access to Genetic Heritage or
Associated Traditional Knowledge, inform if the product consists of fixed oil or extract
resulting from the activities listed in Sect. 107 of Decree n. 8.772/16. If this is not the
case, please specify the type of intermediate product.
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If the intermediate product derives from access to genetic heritage or associated tradi-
tional knowledge, inform the date of completion of the access that gave origin to the
product. If the date of completion of the access is later than June 30, 2000, it will be
necessary to inform the corresponding registration access number.

Sample Types and Packing Methods

Type of sample to be shipped: select the type of sample to be delivered. In case it is not
on the list, select ‘Outros’ and specify.

Packaging method: Inform ‘Forma de acondicionamento (Packaging method)’, ‘Quanti-

dade de Recipientes’ (Number of Containers), ‘Volume a ser remetido’ (Shipping Vol-
ume) and ‘Método de Envio’ (Shipping Method). The field ‘Número de conhecimento
de carga’ (Number of Shipping Receipt) is not required and can be updated later.
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Overseas Recipient Institution

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Prior Authorization for Access or Shipping
A request for prior authorization from the Union, for access or shipping, is included in
the corresponding access or shipping registration, at the user’s disposal.

To request prior authorization, fill out the registration form (see Access and Forward-
ing Registration and Shipping Registration for guidelines) indicating in specific fields the
inclusion of prior authorization, and specifying required approvals (from the National
Defense or Navy Command) (for authorization of access, see Prior Authorization and
Consent from the National Defense Council/Navy Command for access to genetic heritage
and Prior Authorization and Consent from the National Defense Council/Navy Command
for access to associated traditional knowledge; for authorization of shipping, see Prior
Authorization and Consent from the National Defense Council/Navy Command).

Once the registration is completed, it will be forwarded for analysis by competent agencies
for granting of necessary approvals. Progress can be viewed in the registration updating
list (see Update Access and Shipping Registration or Update Forwarding Registration)
and processing data will be informed by electronic message.

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If it is necessary to submit additional information or documents for the requested consent,
as per manifestation from competent agency, see Registration Complementing.

If consent is denied, the system will inform the authorization applicant via registered
email and registration will be automatically canceled.

If permission is granted the system will inform, via email, the authorization applicant and
registration will be completed with the inclusion of the requested prior authorization,
the issuance of a registration receipt and the beginning of administrative verification
procedure (see Verification Procedure).

Additional Registration Data

In case the agency granting the consent requests additional information or documents,
the system will inform the user on SisGen’s homepage. To access this request and forward
complementary information or documents, click on the system’s note or select option
‘Complementar Cadastro’ on the menu ‘Atividade de Acesso’ or on ‘Remessa’, as the
case may be.

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 Notification Finished Product or
Reproductive Material about
To send a notification about finished product or repro-
ductive material, choose option ‘Novo Cadastro’ on the
menu ‘Notificação de Produto’.

Type of User: Identify the institution to which you are associated, responsible for the
economic use of the finished product or reproductive material in the notification. If you
are responsible for the economic use as a natural person, not being associated to any
institution, please select ‘Independente’.
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Type of Product for Notification: Classify the object of notification.

Commercial Identification of Product: Enter product’s commercial identification.

Product’s NCM Classification: Enter product’s classification according to Mercosur

Common Nomenclature.
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Application Sector: Inform product’s sector of application, according to the National
Classification of Economic Activities - CNAE.

Registration, or equivalent, at control agencies: Provide any registers or records in agen-

cies or institutions such as the Ministry of Agriculture, Livestock and Supply - MAPA, the
Brazilian Health Regulatory Agency - Anvisa, the National Institute of Industrial Property
- INPI, the Brazilian Institute of Environment and Renewable Natural Resources - Ibama,
among others. If you have no previous register of the notified product, select the option
‘Não possui registro ou equivalente’.

Estimated start date for commercialization: Inform estimatesd start date for product
commercialization.

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Product is still being economically used? Please inform whether the product is being
economically used. Select ‘Sim’, even if the product is not yet in the market, in case there
is an estimated start date for that. Select ‘Não’ only if there is no intention of economic
use of the finished product or reproductive material, as the product notification will be
closed and updates won’t be allowed.

Benefit Sharing Modality

Exemption

SisGen automatically identifies the cases of benefit sharing exemption. In this way,
the system will only enable option ‘Isento’ in field ‘Modalidade de Repartição de
Benefícios’.

Genetic Heritage - Monetary Modality

When finished product or reproductive material derives exclusively from access to

genetic heritage and does not fit in the options of benefit sharing, the user may choose
between monetary or non-monetary modalities.

If you choose the monetary modality, the system will display the Benefit Sharing section,
which is not required for the conclusion of notification, but must be yearly updated for
payment of benefit sharing.

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Genetic Heritage - Non-monetary Modality

If you choose the non-monetary modality, the system will display a field for attachment
of the benefit sharing agreement.

As provided for by to Law n° 13.123/15, submitting the benefit sharing agreement is

not required for notification conclusion, if there is no associated traditional knowledge
involved, and you may submit it within 365 days.

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After entering and saving information about net revenue and benefit sharing in this
section, the system will display the following table:

After attaching proof of equivalence (comprovante de equivalência), the system will not
anymore allow the edition of net revenue and benefits sharing data for the correspond-
ing fiscal year.

Associated Traditional Knowledge of Non-identifiable

Origin - Monetary Modality

When the finished product or reproductive material derives from Access to Associated
Traditional Knowledge of non-identifiable origin, with no access to traditional knowl-
edge of identifiable origin, and does not fit in the options of benefit sharing exemption,
SisGen will only allow the monetary modality of benefit sharing.

The system will display the Benefit Sharing section, not required for notification conclu-
sion, although yearly updates are necessary for benefit sharing payment.

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Associated Traditional Knowledge of Identifiable
Origin - Monetary or Non-Monetary Modality

When the finished product or reproductive material derives from Access to Associated
Traditional Knowledge of identifiable origin, irrespective of access to genetic heritage or
to associated traditional knowledge of non-identifiable origin, and does not fit in the
options of benefit sharing exemption, user may check either monetary or non-monetary
modalities for benefit sharing.

Regardless of selected benefit sharing modality, submission of benefit sharing agreement

is mandatory for notification conclusion, as provided for in Subsection I, of Paragraph 1
of 1, of Sect. 34, Decree n. 8.772/16

In addition to the submission of the agreement, it is also mandatory to fill in the additional
fields relating to Benefit sharing Agreement.

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 About Signatories of the Benefit Sharing Agreement.

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SisGen will display the list of notifications associated to the user.

In the column ‘Situação’, SisGen informs the notification status, including the following
possibilities:

1 Ativa (Active): Indicates active notifications, under verification procedure during the
first 60 days, which must be annually updated for the sharing of benefits.

2 Aguardando Acordo de Repartição de Benefícios (Awaiting Benefit Sharing Agree-

ment): Indicates cases of notification of a product derived from genetic heritage in which
the user has chosen the non-monetary modality for benefit sharing, but has not yet
submitted the benefit sharing agreement.

3 Cancelada (Cancelled): Indicates notifications canceled by CGEN or due to failure in

submitting the benefit sharing agreement within 365 days, when applicable.

4 Concluída (Complete): Indicates notifications in which the user reported that the
finished product or reproductive material is no longer being economically used and
that all due benefit sharing payment have been settled. In this case, notification can no
longer be updated.

In case of a notification with a pending submission of benefit sharing agreement,

the column ‘Prazo de Aresentação do ARB’ shows remaining days before the end of
the 365-day period.

To display an entered notification, click the icon in column ‘Visualizar’. To update a noti-
fication, click the icon in column ‘Editar’.
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When updating a notification, the following fields can be edited:

1 Scope of Commercialization of Finished Product or Reproductive Material.

2 Register, or equivalent, at control agencies (for adding only).

3 Estimated Start Date for Commercialization.

4 Product is still being economically used?

Verification Procedure

Upon conclusion of an access registration, a shipping registration or a notification on

finished product or reproductive material at SisGen, the administrative procedure of
verification is automatically started, pursuant to Section VII of Decree n. 8.772/16. In case
of access or shipping registration requiring prior authorization (see Prior Authorization
for Access or Shipping), the administrative verification procedure will only start after the
registration is completed with previous consents and authorizations.

Administrative verification procedure takes 60 days, during which CGEN’s Executive

Department will check for irregularities in registers or notifications, and CGEN’s Board
Members may submit a request for verification of possible irregularities.

If irregularities are identified or verification is requested by CGEN’s Board, the system will
notify the user, by electronic message and on the initial page of SisGen, on the need to
submit a response to this in 15 days. To view the request or to supplement information or
documentation as requested, click the system’s notice or select the option ‘Manifestar
sobre requerimento de verificação’ on the menu ‘Atividade de Acesso’, ‘Remessa’ ou
‘Notificação de Produto’, as the case may be.

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Access Regularity Certificate
To request an ‘Access Regularity Certificate’ (Atestado de Regularidade de Acesso)’,
select the appropriate Access Registration activity in section ‘Atualizar Cadastro’ (see
Atualizar cadastro de acesso e envio).

At the end of the registration form, a certificate of regularity of access can be requested.
If you wish, you may include comments to your request.

The access regularity certificate will be forwarded to CGEN’s Board, through their
Executive Department, for consideration. After the Board’s deliberative session, the user
will be notified of the decision by electronic message.

In case CGEN’s Board deliberates for the issuance of the access regularity certificate,
the document will be made available in the column ‘Atestado de Acesso’, for the
corresponding register, under the menu ‘Atualizar cadastro’.
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Accreditation of Institution that Maintains
ex-situ Collection
To request accreditation of an institution that maintains an ex-situ collection, please select
the option ‘Novo Credenciamento’ on the menu ‘Credenciamento de Coleção ex-situ’
of SisGen. Accreditation must be individually requested for each ex-situ collection.

Collection Identification

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Type of Preserved Sample

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Curator

Inform the curator of the ex-situ collection under registration. It is possible to add more
than one curator. The curator of the ex-situ collection in the scope of SisGen must be
a registered user.

Upon completing the form, the accreditation request will be forwarded for considera-
tion by CGEN’s Board, pursuant to clause ‘b’ of Subsection III, §1 of Sect. 6 of Law
n. 13.123/15.

CGEN’s decision will be communicated by email to the users indicated as curators of

the ex-situ collection and to the legal representative of the institution. Upon complet-
ing the form, the accreditation request will be forwarded for consideration by CGEN’s
Board, pursuant to clause ‘b’ of Subsection III, §1 of Sect. 6 of Law n. 13.123/15.

CGEN’s decision will be communicated by email to the users indicated as curators of

the ex-situ collection and to the legal representative of the institution.

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 About the Author

Ana Claudia Dias de Oliveira holds a Biology degree and a

Master’s in Animal Biology from the Federal Rural University of
Rio de Janeiro, and a PHD in Plant Biotechnology from the Federal
University of Rio de Janeiro. She also holds a PHD in Business
Competitive Intelligence and Intellectual Property from the Federal
University of Rio de Janeiro. The emphasis of her academic work
is on Intellectual Property and Biodiversity. She is currently a
Visiting Specialist at Fiocruz Innovation Office in the Center for
Technological Development in Health - CDTS/FIOCRUZ; INCT-
IDPN - Project 465313/2014-0), and a consultant for companies,
such as ABIFINA, and legal entities, including pharmaceutical
companies, chemical companies, Universities and Institutions of
Science and Technology (ICTs).

She is a collaborator professor at Farmanguinhos Specialist-

Level Programs in Phytomedicine Innovation Management and
at Fiocruz Master’s Program in Industrial Drug Technology.
Since 2000, the author has dedicated to the field of Intellectual
Property and Biodiversity. As a member of the Genetic Heritage
Management Council - CGEN, she is a representative of the
industrial sector (CNI).

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