THE BRAZILIAN LEGISLATION ON ACCESS AND ...... LAW Nº 13.123, FROM 20 OF MAI 2015 THE NEW BRAZILIAN ABS LEGISLATION DECREE Nº 8.772, FROM 11 OF MAY 2016 Regulates Law No. 13,123,

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THE BRAZILIAN LEGISLATION ON ACCESS AND BENEFIT SHARING

MANUELA DA SILVA - FIOCRUZ – FUNDAÇÃO OSWALDO CRUZ

VICE-PRESIDENCY OF RESEARCH AND BIOLOGICAL COLLECTIONS

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LAW Nº 13.123, FROM 20 OF MAI 2015

THE NEW BRAZILIAN ABS LEGISLATION

DECREE Nº 8.772, FROM 11 OF MAY 2016

Regulates Law No. 13,123, of May 20, 2015, which provides for access to

genetic resources, the protection and access to associated traditional

knowledge and the sharing of benefits for conservation and sustainable

use of biodiversity.

After almost 6 months since the

law came into force, the Decree

regulating it was published. Thus,

we had a scenario in which there

was a law in force without

regulation, which prevented its

implementation.

The law was published on May

21, 2015 and entered into force

on November 17, 2015

Regulates the section II of § 1 and § 4 of article 225 of the Federal

Constitution, Article 1, point j of Article 8, point c of Article 10, Article 15

and §§ 3 and 4 of Article 16 of the Convention on Biological Diversity,

promulgated by Decree No. 2519 of 16 March 1998, provides for access to

genetic heritage, on the protection and access to associated traditional

knowledge and the benefit sharing for conservation and sustainable use of

biodiversity; revokes the Provisional Act 2.186/2001, 23 August 2001, and

takes other measures.

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implementation.












Now we have law and

regulation, but after 2 years of the

publication of the new law, we are

still waiting for SisGen. The system

can not be available before the

installation of the Executive

Secretary

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implementation.












The Executive Secretary

was at last installed.

However we are still

waiting to have SisGen

available

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ABS NATIONAL COMPETENT AUTHORITY

The Brazilian ABS National Competent Authority is the Genetic Heritage Management

Council - CGen

CGen consists of representatives from bodies and entities of the federal public

administration that are competent on the various actions of this law and the

representation of civil society.

There are 11 Ministries and 9 representatives of civil society, 3 of each of the

following sectors:

• Business sector

• Academia

• Indigenous peoples, traditional communities and traditional farmers

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The Brazilian ABS National Competent Authority is the Genetic Heritage Management

Council - CGen

CGen consists of representatives from bodies and entities of the federal public

administration that are competent on the various actions of this law and the

representation of civil society.

There are 11 Ministries and 9 representatives of civil society, 3 of each of the

following sectors:

• Business sector

• Academia

• Indigenous peoples, traditional communities and traditional farmers

SBPC – Brazilian Society for the Science Progress; ABC - Brazilian Academy of Science, ABA - Brazilian Association of Anthropology

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CGEN WORKS BY MEANS OF:

I. Plenary

II. Thematic Chambers

III. Sectorial Chambers

IV. Executive Secretary


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CGEN WORKS BY MEANS OF:

I. Plenary

II. Thematic Chambers

III. Sectorial Chambers

IV. Executive Secretary


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PARTICIPANTS OF THE ACADEMY SECTORIAL CHAMBER

CGEN member who indicated Name and Institution

SBPC, ABC e ABAAndré Luis de Gasper – Universidade Regional de Blumenau

Coordenador da Rede de Herbários da Sociedade Botânica do Brasil

SBPC, ABC e ABAManuela da Silva - Fundação Oswaldo Cruz/RJ

Coordenadora das Coleções Biológicas da Fiocruz/ Sociedade Brasileira de Microbiologia

SBPC, ABC e ABALuciane Marinoni - Universidade Federal do Paraná

Presidente da Sociedade Brasileira de Zoologia

SBPC, ABC e ABAMarcelo H. A. Freitas - Secretaria de Relações Internacionais - Coordenadoria de Políticas

Globais/Embrapa

SBPC, ABC e ABA Laura Rodrigues Santonieri

SBPC, ABC e ABA Diego Soares da Silveira - Instituto de Ciências Sociais da Universidade Federal de Uberlândia

André Fábio De Souza – MDIC André Fábio de Souza – MDIC

Maira Smith – MJSP Maira Smith – MJSP

Fabrício - MAPA Rosa Míriam - Embrapa

Bruno César Prosdocimi Nunes - MCTIC Ricardo Henrique Kruger - Instituto de Biologia da Universidade de Brasília

Bruno César Prosdocimi Nunes - MCTICKátia Regina Torres - Departamento de Assistência Farmacêutica e Insumos Estratégicos, Ministério da Saúde

Rafael Marques – MMA Henry Philippe Ibanez de Novion – MMA

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ORIGINATED FROM THE ACCESS OF GENETIC

HERITAGE

ORIGINATED FROM THE ACCESS OF ASSOCIATED

TRADITIONAL KNOWLEDGE

THE LAW

COVERS THE

ACTIVITY OF

SCOPE OF THE LAW 13.123/15

THIS IS THE MOMENT WHEN THERE IS BENEFIT SHARING

• FINISHED PRODUCT OR

• REPRODUCTIVE MATERIAL

• RESEARCH

• TECHNOLOGICAL DEVELOPMENT

• ECONOMIC EXPLOITATION

ACCESS = UTILIZATION

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It refers to plant propagation material or animal reproduction of any genus,

species or cultivation from sexual or asexual reproduction

FINISHED PRODUCT

REPRODUCTIVE MATERIAL

ECONOMIC EXPLOITATION

Product whose nature does not require any additional production process,

arising from access to genetic heritage or associated traditional knowledge, in

which the component of the genetic heritage or associated traditional

knowledge is a key element of added value to the product, being able to be

used by the final consumer, whether natural or legal person

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DIFERENTLY FROM THE PREVIOUS LEGISLATION, THE NEW LAW:

information of genetic origin from

plants, animals, microorganisms or

species of other nature, including

substances derived from the

metabolism of these living beings

REACHES ALL RESEARCH

(EXPERIMENTAL OR

THEORETICAL) CONDUCTED

WITH THE BRAZILIAN

GENETIC HERITAGE

DEFINITION

BASIC RESEARCH SUCH AS:

• EPIDEMIOLOGY

• MOLECULAR ECOLOGY

• MOLECULAR TAXONOMY

• PHYLOGENY

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DIFERENTLY FROM THE PREVIOUS LEGISLATION, THE NEW LAW:

information of genetic origin from

plants, animals, microorganisms or

species of other nature, including

substances derived from the

metabolism of these living beings

REACHES ALL RESEARCH

(EXPERIMENTAL OR

THEORETICAL) CONDUCTED

WITH THE BRAZILIAN

GENETIC HERITAGE

DEFINITION

USE OF INFORMATION FROM

GENETIC SEQUENCES PUBLISHED IN

PUBLIC DATA BASES (GenBank)

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The microorganism that has been isolated from

OTHER NOVELTY IN THE LAW IS THE PARAGRAPH ON MICROORGANISMS


is considered Brazilian genetic resource for the purposes of this law

National territory substrates

Territorial seaExclusive

economic zoneContinental shelf

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ACTIVITIES THAT ARE SUBJECT TO THE LAW

I. Access to genetic heritage and associated traditional

knowledge;

II. Shipment abroad of genetic heritage

III. Economic exploitation of finished product or reproductive

material from access to genetic heritage and associated

traditional knowledge

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REGISTRATION

RESEARCH

TECHNOLOGICAL DEVELOPMENT

FOR COMPLYING WITH THE LAW

THE REGISTRATION SHOULD BE CONDUCTED PRIOR TO:

• Shipment abroad

• Request of any intellectual property right

• Commercialization of any intermediate product

• Release of results, final or partial, in scientific or communication circles

• Notification of finished product or reproductive material developed as a

result of the access

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REGISTRATION

RESEARCH


NOTIFICATION BEFORE ECONOMIC EXPLOITATION

FOR COMPLYING WITH THE LAW

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NOTIFICATION

For economic exploitation will be required:

I. prior notification of the finished product or the reproductive

material to CGen

II. presentation of the benefit-sharing agreement (BSA) within 1

year from the time of notification, except in the case of

finished product or reproductive material from access to ATK

of identifiable origin. In this case, the agreement must be

presented at the time of notification

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AUTHORIZATION

The authorization will be required only in cases where there is some involvement of

foreigners:

I - National legal entity whose controlling shareholders or members who are natural or legal

foreign persons

II - national institution of scientific research and technology, public or private, when access

is made in association with legal entity based abroad

III - Brazilian natural person associated, funded or contracted by a legal entity based abroad

THE AUTHORIZATION SHALL BE CARRIED OUT PRIOR TO:

• Access to GH or ATK in area indispensable to national security

• Access to GH or ATK in Brazilian territorial waters, continental shelfand exclusive economic zone

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THE POSSIBILITY OF LINKING ITS

SOURCE TO AT LEAST AN

INDIGENOUS POPULATION,

TRADITIONAL COMMUNITY OR

TRADITIONAL FARMER

ASS

OC

IATE

D T

RA

DIT

ION

AL

KN

OW

LED

GE

OF IDENTIFIABLE SOURCE

WHEN THERE IS

WHEN THERE IS NOT

ACCESS TO ASSOCIATED TRADITIONAL KNOWLEDGE

OF UNIDENTIFIABLE

SOURCE

THE TRADITIONAL KNOWLEDGE ASSOCIATED TO GENETIC HERITAGE

CAN BE RECOGNIZED IN SCIENTIFIC PUBLICATIONS, RECORDS IN

REGISTERS OR DATABASES AND CULTURAL INVENTORIES

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TRADITIONAL FARMER

ASS

OC

IATE

D T

RA

DIT

ION

AL

KN

OW

LED

GE


WHEN THERE IS

WHEN THERE IS NOT


OF UNIDENTIFIABLE

SOURCE

ANY INDIGENOUS POPULATION, TRADITIONAL COMMUNITY OR

TRADITIONAL FARMER WHO CREATES, DEVELOPS, HOLDS OR

PRESERVES CERTAIN TRADITIONAL KNOWLEDGE IS AN IDENTIFIABLE

SOURCE OF SUCH KNOWLEDGE

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TRADITIONAL FARMER

ASS

OC

IATE

D T

RA

DIT

ION

AL

KN

OW

LED

GE


WHEN THERE IS

WHEN THERE IS NOT


OF UNIDENTIFIABLE

SOURCE

THE ACCESS TO THIS KNOWLEDGE IS SUBJECT TO

OBTAINING PREVIUS INFORMED CONSENT - PIC

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DEFINITION: TRANSFERENCE OF GENETIC HERITAGE TO AN INSTITUTION

LOCATED IN ANOTHER COUNTRY WITH THE PURPOSE OF ACCESS, IN WHICH

THE RESPONSABILITY OF THE GH IS TRANSFERRED TO THE RECEPIENT

INSTITUTION

SHIPMENT ABROAD WILL HAVE TO BE REGISTERED IN CASES WHERE ACCESS

TO GENETIC RESOURCES ARE CONDUCTED BY:

• LEGAL ENTITY LOCATED ABROAD THAT IS ASSOCIATED TO NATIONAL INSTITUTION

(PUBLIC OR PRIVATE)

• NATIONAL INDIVIDUAL OR LEGAL ENTITY (PUBLIC OR PRIVATE) THAT IS ABROAD

SHIPMENT ABROAD OF GENETIC HERITAGE

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SHIPMENT ABROAD OF GENETIC HERITAGE

REGISTRATION FOR SHIPMENT ABROAD MUST BE PERFORMED PRIOR

SHIPMENT AND DEPENDS ON:

• THE SIGNATURE OF MATERIAL TRANSFER AGREEMENT – MTA

• THE SUPLY OF INFORMATION ABOUT THE PROVIDER AND RECIPEINT

INSTITUTIONS, GENETIC HERITAGE AND INTENDED USE

DEFINITION: TRANSFERENCE OF GENETIC HERITAGE TO AN INSTITUTION

LOCATED IN ANOTHER COUNTRY WITH THE PURPOSE OF ACCESS, IN WHICH

THE RESPONSABILITY OF THE GH IS TRANSFERRED TO THE RECEPIENT

INSTITUTION

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MATERIAL TRANSFER AGREEMENT

The MTA formalizes the shipment abroad of samples of genetic

heritage accessed or available for access

It will predict that:

• It shall be interpreted in accordance with Brazilian law

• The recipient institution will not be considered provider of the GH

It will contain clauses that:

• Inform on access to ATK when applicable

• Authorizes or prohibits the transfer of the GH to third parties

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MATERIAL TRANSFER AGREEMENT

In the case of authorization, the transfer of genetic heritage to third parties

will also depend on a MTA containing the above requirements. This

obligation will be applied to all subsequent transfers

The MTA formalizes the shipment abroad of samples of genetic

heritage accessed or available for access

It will predict that:

• It shall be interpreted in accordance with Brazilian law

• The recipient institution will not be considered provider of the GH

It will contain clauses that:

• Inform on access to ATK when applicable

• Authorizes or prohibits the transfer of the GH to third parties

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MATERIAL TRANSFER AGREEMENT MODEL APPROVED BY CGEN

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MINISTRY OF ENVIRONMENT

GENETIC HERITAGE MANAGEMENT COUNCIL

Union Official Gazette, November 30, 2016 (n. 229, Section 1, page 76)

Approves the model of Material Transfer Agreement - MTA.

THE GENETIC HERITAGE MANAGEMENT COUNCIL - CGen, exercising the powers granted by Law n. 13.123, dated

May 20, 2015, and Decree n. 8.772, dated May 11, 2016, according to its Internal Regulations, annexed to Order

MMA n. 427, dated September 29, 2016, resolve to:

Art. 1 - Approve the model of Material Transfer Agreement - MTA, as set out in the annex to this Resolution.

Art. 2 - As requested in Article 25 of Decree n. 8.772, dated May 11, 2016, the clauses presented in this model of

MTA are mandatory.

Sole paragraph - Additional clauses may be annexed to the MTA, in order to address specific interests of the sender

or the receiver, since they do not conflict with this Resolution or the pertinent legislation.

Art. 3 - This Resolution shall enter into force on the date of its publication.

JOSÉ PEDRO DE OLIVEIRA COSTA

President of CGen

www.fiocruz.br


MINISTRY OF ENVIRONMENT

GENETIC HERITAGE MANAGEMENT COUNCIL

Union Official Gazette, November 30, 2016 (n. 229, Section 1, page 76)

Approves the model of Material Transfer Agreement - MTA.

THE GENETIC HERITAGE MANAGEMENT COUNCIL - CGen, exercising the powers granted by Law n. 13.123, dated

May 20, 2015, and Decree n. 8.772, dated May 11, 2016, according to its Internal Regulations, annexed to Order

MMA n. 427, dated September 29, 2016, resolve to:

Art. 1 - Approve the model of Material Transfer Agreement - MTA, as set out in the annex to this Resolution.

Art. 2 - As requested in Article 25 of Decree n. 8.772, dated May 11, 2016, the clauses presented in this model of

MTA are mandatory.

Sole paragraph - Additional clauses may be annexed to the MTA, in order to address specific interests of the sender

or the receiver, since they do not conflict with this Resolution or the pertinent legislation.

Art. 3 - This Resolution shall enter into force on the date of its publication.

JOSÉ PEDRO DE OLIVEIRA COSTA

President of CGen

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ANNEX 01

Definitions:

1 - Legal person: a set of people or goods, with own legal personality and legally established.

2 - Natural person: any person capable of acquiring rights and duties in the civil order.

3 - Access to the genetic heritage - research or technological development carried out performed on genetic heritage samples;

4- Genetic heritage - genetic information from plants, animals, and microbial species, or any other species, including substances originating from the metabolism of these living organisms;

5 - Research - experimental or theoretical activity, carried out on genetic heritage or associated traditional knowledge with the objective of building new knowledge by means of a systematic process that creates and tests hypothesis, describes and interprets fundamentals of observed phenomena and facts;

6 - Technological development - systematic work on genetic heritage or associated traditional knowledge, based on existing procedures resulting from research or from practical experience, carried out with the objectives of developing new materials, products or devices, or improving or developing new processes, for economic exploitation;

7 - Associated traditional knowledge - information or practice of indigenous population, traditional community, or traditional farmers about the properties, or the direct or indirect uses associated with genetic heritage;

8 - Product notification - declaration document required prior to economic exploitation of a finished product or reproductive material originating from access to genetic heritage or to associated traditional knowledge in which the user declares compliance with the requirements of Law n. 13.123, dated May 20, 2015, and indicates the modality of benefit sharing, when applicable, to be established in the benefit sharing agreement;

9 - Shipment - transfer of a sample of genetic heritage, intended for access, to an institution located abroad, in which responsibility for the sample is transferred to the recipient institution.

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MATERIAL TRANSFER AGREEMENT - MTA

THE MATERIAL TRANSFER AGREEMENT - MTA, legal document under the terms of Article 25 (III), of Decree n. 8.772, dated

May 11, 2016 is signed:

Between:

If the sender is a Legal Person1:

[NAME OF INSTITUTION ACCORDING TO THE NATIONAL REGISTER OF LEGAL ENTITIES (CNPJ)], legal person registered in the

CNPJ/MF under n. [CNPJ number], headquartered in [ADDRESS], n. [NUMBER], [SUPPLEMENT], [MUNICIPALITY], [FU], ZIP

CODE [ZIP CODE NUMBER], herein represented according to its [INFORMATION ON THE DOCUMENT OF ESTABLISHMENT],

upon [INSTRUMENT OF DELEGATION], by [FULL NAME OF THE LEGAL REPRESENTATIVE], [NATIONALITY], [MARITAL STATUS],

[PROFESSION], with CPF n. [CPF number], holder of ID RG n. [ID RG number], issuing agency [ISSUING AGENCY], FU [FU],

domiciled at [ADDRESS], n. [NUMBER], [SUPPLEMENT], neighborhood [NEIGHBORHOOD], municipality [MUNICIPALITY] -

[FU], ZIP CODE n. [ZIP CODE NUMBER], hereinafter simply referred to as "SENDER",

If the sender is a Natural Person2:

[FULL NAME], [NATIONALITY], [MARITAL STATUS], [PROFESSION], with CPF n. [CPF number], holder of ID RG n. [ID RG

number], issuing agency [ISSUING AGENCY], FU [FU], domiciled at [ADDRESS], n. [NUMBER], [SUPPLEMENT], neighborhood

[NEIGHBORHOOD], municipality [MUNICIPALITY] - [FU], ZIP CODE n. [ZIP CODE NUMBER], hereinafter simply referred to as

"SENDER",

AND:

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If the receiver is a Legal Person:

[NAME OF THE RECEIVING INSTITUTION as registered in the host country], legal person headquartered in [FULL ADRESS],

[MUNICIPALITY], [REGION / STATE], POSTAL CODE [POSTAL CODE], [COUNTRY], herein represented upon [INSTRUMENT OF

DELEGATION] by [FULL NAME OF THE LEGAL REPRESENTATIVE], [NATIONALITY], [POSITION], holder of ID RG n. [ID RG

number], domiciled at [FULL ADDRESS], [MUNICIPALITY], [REGION / STATE], POSTAL CODE [POSTAL CODE], [COUNTRY],

hereinafter simply referred to as "RECEIVER".

If the receiver is a Natural Person:

[FULL NAME], BRAZILIAN, [MARITAL STATUS], [PROFESSION], with CPF n. [CPF number], holder of ID RG n. [ID RG number],

issuing agency [ISSUING AGENCY], FU [FU], domiciled at [FULL ADDRESS], [MUNICIPALITY], [REGION / STATE], POSTAL CODE

[POSTAL CODE], [COUNTRY], hereinafter simply referred to as "RECEIVER",

Since the RECEIVER must comply with the provisions of Law n. 13.123, dated May 20, 2015 and of Decree n. 8.772, dated

May 11, 2016, to access3 the samples of genetic heritage4 consisting of the subject matter of this MTA for purposes of

research activities5 and technological development6, the RECEIVER states to be aware that he/she must:

a) Be associated with a Brazilian institution of scientific and technological research to perform research or technological

development from this (these) sample(s) of genetic heritage, in case of a foreign legal person;

b) Register the research and technological development activity performed with the object of this MTA or with the

associated traditional knowledge7 at SisGen (sisgen.gov.br), through the associated Brazilian institution;

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If the receiver is a Legal Person:

[NAME OF THE RECEIVING INSTITUTION as registered in the host country], legal person headquartered in [FULL ADRESS],

[MUNICIPALITY], [REGION / STATE], POSTAL CODE [POSTAL CODE], [COUNTRY], herein represented upon [INSTRUMENT OF

DELEGATION] by [FULL NAME OF THE LEGAL REPRESENTATIVE], [NATIONALITY], [POSITION], holder of ID RG n. [ID RG

number], domiciled at [FULL ADDRESS], [MUNICIPALITY], [REGION / STATE], POSTAL CODE [POSTAL CODE], [COUNTRY],

hereinafter simply referred to as "RECEIVER".

If the receiver is a Natural Person:

[FULL NAME], BRAZILIAN, [MARITAL STATUS], [PROFESSION], with CPF n. [CPF number], holder of ID RG n. [ID RG number],

issuing agency [ISSUING AGENCY], FU [FU], domiciled at [FULL ADDRESS], [MUNICIPALITY], [REGION / STATE], POSTAL CODE

[POSTAL CODE], [COUNTRY], hereinafter simply referred to as "RECEIVER",

Since the RECEIVER must comply with the provisions of Law n. 13.123, dated May 20, 2015 and of Decree n. 8.772, dated

May 11, 2016, to access3 the samples of genetic heritage4 consisting of the subject matter of this MTA for purposes of

research activities5 and technological development6, the RECEIVER states to be aware that he/she must:

a) Be associated with a Brazilian institution of scientific and technological research to perform research or technological

development from this (these) sample(s) of genetic heritage, in case of a foreign legal person;

b) Register the research and technological development activity performed with the object of this MTA or with the

associated traditional knowledge7 at SisGen (sisgen.gov.br), through the associated Brazilian institution;

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c) Register the research and technological development activity previously to the requirement of any intellectual property

right or intermediate product marketing, or dissemination of final, or partial results in scientific or communication media,

or notification of finished product, or reproductive material developed due to access, through the associated Brazilian

institution;

d) Notify8 through SisGen (sisgen.gov.br) and Share Benefits, in case of economic exploitation of finished product, or

reproductive material developed from the subject of this MTA, through the associated Brazilian institution;

e) Obtain the prior and informed consent from the provider of the local traditional variety or landrace, or locally adapted

race or land breed to perform research and technological development activities, in cases where the samples are not used

for agricultural activities, through the associated Brazilian institution; and

f) Obtain the prior and informed consent from the provider in case of research and technological development activities

related to the associated traditional knowledge of samples object of this MTA, through the associated Brazilian institution.

The above-described signatory parties, through their duly constituted representatives, decide to sign this MTA, upon the

following clauses and conditions:

1. This Agreement aims the shipment9 of the samples of genetic heritage described below, in accordance with Article 12, IV,

of Law n. 13.123, dated May 20 2015, by the SENDER to the RECEIVER and will integrate the Registry of Shipment in the

National System for Genetic Heritage and Associated Traditional Knowledge Management - SisGen.

1.1. This shipment will be performed after its registration at SisGen (sisgen.gov.br), by the SENDER, in accordance with § 2,

Article 12, Law n. 13.123, dated May, 20, 2015.

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c) Register the research and technological development activity previously to the requirement of any intellectual property

right or intermediate product marketing, or dissemination of final, or partial results in scientific or communication media,

or notification of finished product, or reproductive material developed due to access, through the associated Brazilian

institution;

d) Notify8 through SisGen (sisgen.gov.br) and Share Benefits, in case of economic exploitation of finished product, or

reproductive material developed from the subject of this MTA, through the associated Brazilian institution;

e) Obtain the prior and informed consent from the provider of the local traditional variety or landrace, or locally adapted

race or land breed to perform research and technological development activities, in cases where the samples are not used

for agricultural activities, through the associated Brazilian institution; and

f) Obtain the prior and informed consent from the provider in case of research and technological development activities

related to the associated traditional knowledge of samples object of this MTA, through the associated Brazilian institution.

The above-described signatory parties, through their duly constituted representatives, decide to sign this MTA, upon the

following clauses and conditions:

1. This Agreement aims the shipment9 of the samples of genetic heritage described below, in accordance with Article 12, IV,

of Law n. 13.123, dated May 20 2015, by the SENDER to the RECEIVER and will integrate the Registry of Shipment in the

National System for Genetic Heritage and Associated Traditional Knowledge Management - SisGen.

1.1. This shipment will be performed after its registration at SisGen (sisgen.gov.br), by the SENDER, in accordance with § 2,

Article 12, Law n. 13.123, dated May, 20, 2015.

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2. Information identifying samples of genetic heritage to be shipped:2.1. Identification of the genetic heritage samples at the lowest possible taxonomic level:

2.2. Origin of samples to be shipped including georeferenced coordinates (degrees, minutes and seconds) of the in situ

source, even if they were obtained from ex situ sources:

[OR]___________________________________________________________________________

2.2. Identification of the ex situ source from where the genetic heritage was obtained, with information described in the

deposit record, when obtained from an ex situ collection as required by §1 of Article 22 of Decree n. 8.772, dated May 11,

2016:

2.3. Information on the type of sample and the packaging form:

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2.4. Quantity of containers, volume or weight:

2.5. Information on the access activities to be carried out abroad:

3. The RECEIVER declares that he will use the samples of genetic heritage received for:

3.1. a) The RECEIVER must notify the CGen ([email protected]) of any change of information indicated in item 3.

[OR]

3.1. b) The samples consisting of the subject matter of this MTA must be used exclusively for the purposes, intended uses

and sector of application indicated in item 3.

[OR]

3.1. c) The RECEIVER depends on the SENDER’s authorization for any changes of purposes, intended use and sector of

application indicated in item 3.

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2.4. Quantity of containers, volume or weight:

2.5. Information on the access activities to be carried out abroad:

3. The RECEIVER declares that he will use the samples of genetic heritage received for:

3.1. a) The RECEIVER must notify the CGen ([email protected]) of any change of information indicated in item 3.

[OR]

3.1. b) The samples consisting of the subject matter of this MTA must be used exclusively for the purposes, intended uses

and sector of application indicated in item 3.

[OR]

3.1. c) The RECEIVER depends on the SENDER’s authorization for any changes of purposes, intended use and sector of

application indicated in item 3.

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4. The material is a local traditional variety or landrace or a locally adapted race or land breed?

( ) Yes.

( ) No.

5. The RECEIVER recognizes that he is not the provider of the samples of genetic heritage consisting of the subject matter of

this MTA.

6. The transfer of genetic heritage samples, object of this MTA, to third parties is prohibited.

[OR]

6. The samples of genetic heritage may be transmitted to third parties.

6.1. To transfer the samples of genetic heritage to third parties, the RECEIVER will require from the subsequent receiver the

signature of a new MTA containing all clauses of this MTA, with permission to change the purposes, intended use and

sector of application indicated in item 3 of this document.

6.2. The RECEIVER is responsible for notifying the CGen ([email protected]) of any subsequent transferring of the material

object of this MTA.

6.3. The provisions of items 6.1 and 6.2 apply to all subsequent transmissions.

7. The RECEIVER is aware that the noncompliance with the provisions of this MTA can result in application of sanctions

provided by Law n. 13.123, dated May 20, 2015.

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4. The material is a local traditional variety or landrace or a locally adapted race or land breed?

( ) Yes.

( ) No.

5. The RECEIVER recognizes that he is not the provider of the samples of genetic heritage consisting of the subject matter of

this MTA.

6. The transfer of genetic heritage samples, object of this MTA, to third parties is prohibited.

[OR]

6. The samples of genetic heritage may be transmitted to third parties.

6.1. To transfer the samples of genetic heritage to third parties, the RECEIVER will require from the subsequent receiver the

signature of a new MTA containing all clauses of this MTA, with permission to change the purposes, intended use and

sector of application indicated in item 3 of this document.

6.2. The RECEIVER is responsible for notifying the CGen ([email protected]) of any subsequent transferring of the material

object of this MTA.

6.3. The provisions of items 6.1 and 6.2 apply to all subsequent transmissions.

7. The RECEIVER is aware that the noncompliance with the provisions of this MTA can result in application of sanctions

provided by Law n. 13.123, dated May 20, 2015.

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8. The MTA must be interpreted according to Brazilian laws and, in case of litigation, the competent jurisdiction will be from

Brazil, indicated by the SENDER, admitting arbitration when agreed by the parties.

For agreeing with all terms above mentioned, the RECEIVER and SENDER representatives sign this MTA in, at least, 2 (two)

copies of same content and form, for only one legal effect.

In case of sample transmission of a local traditional variety or landrace or a locally adapted race or land breed, the SENDER

will send one additional counterpart of this MTA to the provider, when identified.

Place and date:

SENDER’s representative: (space for Signature) / (Name of the sender’s representative) (CPF)

RECEIVER’s representative: (space for Signature) / (Name of the receiver’s representative) (Position)

1st Copy signed (sender)

2nd Copy signed (follows the samples)

One scanned copy must be e-mailed to the CGen ([email protected])

mailto:[email protected]

www.fiocruz.br

SENDING OF GENETIC HERITAGE

DEFINITION: SENDING OF GH FOR SERVICES PROVIDED ABROAD, AS PART OF

A RESEARCH OR TECHNOLOGICAL DEVELOPMENT, IN WHICH THE

RESPONSIBILITY FOR THE GH IS NOT TRASFERED

www.fiocruz.br

TESTS

DEFINITION: SENDING OF GH FOR SERVICES PROVIDED ABROAD, AS PART OF

A RESEARCH OR TECHNOLOGICAL DEVELOPMENT, IN WHICH THE

RESPONSIBILITY FOR THE GH IS NOT TRASFERED

SERVICES PROVIDED

ABROAD ARE CONSIDERED

PERFORMED BY AN INSTITUTION COLABORATING WITH THE NATIONAL

INSTITUTION RESPONSIBLE BY THE ACCESS OR BY WHICH IT WAS HIRED

SPECILIZED TECHNIQUES

SENDING OF GENETIC HERITAGE

www.fiocruz.br

DIFFERENCES BETWEEN SHIPPING AND SENDING IN THE CASE OF SCIENTIFIC

PARTERNESHIP

Sending:

• No need of a previousregistration

• There is no transfer ofresponsibility on the sample

• The sample is accompaniedby a legal instrument

• The sample must bedestroyed or returned

Shipping:

• Previous registration needed

• There is transfer ofresponsibility on the sample

• The sample is accompaniedby Material TransferAgreement - MTA

• The sample can remain in therecipient

LEGAL OPINION: DIFFERENCES BETWEEN SHIPPING AND SENDING

www.fiocruz.br

EVALUATION BY FIOCRUZ REGARDING MMA LEGAL OPINION

• The SHIPPMENT is broader and can be used for practically all situations, except for

the specific case of service supply, for instance genetic sequencing, which is classified

as SENDING in the Law 13.123/15.

• In the context of scientific partnership, the data is shared as well as the resulting

scientific output. When the transport is classified as SENDING, the foreign partner

institution would be prohibited from economically exploiting and filing any patent

application.

• There is no significant simplification regarding the procedures for SENDING in relation

to SHIPMENT, since in both cases a registration and a legal instrument or MTA are

needed. The difference is the moment of the registration, in the case of SHIPPMENT

the registration must be prior.

DIFFERENCES BETWEEN SHIPPING AND SENDING

www.fiocruz.br

• The Law and the Decree do not clarify or define what would mean transference of

responsibility, so it can be more than transfer of ownership and so we can have the

following understanding:

Shipping: when there is a transfer of responsibility, which refers to compliance with

applicable law, liability for damages in the use and disposal of material, etc.

Sending: when there is no transfer of responsibility, therefore Fiocruz or another

research institution will be responsible for the non-compliance with applicable law and

for damages in the use and improper disposal of the biological material

DIFFERENCES BETWEEN SHIPPING AND SENDING

www.fiocruz.br

RESEARCH BY FOREIGNERS

BRAZILIAN BIODIVERSITY CAN ONLY BE ACCESSED BY

FOREIGN INSTITUTION(LEGAL ENTITY LOCATED

ABROAD)

BRAZILIAN INSTITUTION

(PUBLIC OR PRIVATE)

in partnership with

If access occurs in Brazil, an Authorization's

Request for Collecting and Research

(Scientific Expeditions) has to be obtained

from the Brazilian Institution for the Foreign

Institution before the Registration in SisGen

NATIONAL COUNCIL FOR SCIENTIFIC AND TECHNOLOGICAL

DEVELOPMENT

THAT WILL BE RESPONSIBLE FOR THE REGISTRATION

AND UPDATING SisGen (REGISTRY, NOTIFICATION,

BENEFIT SHARING PAYMENT)

www.fiocruz.br

BENEFIT SHARING

CLEAR AND FIXED RULES FOR BENEFIT SHARING WERE ESTABLISHED

THAT CAN BE:

• MONETARY, WITH THE PERCENTAGE OF 1% OF ANNUAL NET REVENUE OR UP TO

0.1% BY SECTORIAL AGREEMENT, OR

• NON MONETARY

ONLY THE MANUFACTURER OF THE FINISHED PRODUCT OR THE

PRODUCER OF THE REPRODUCTIVE MATERIAL WILL BE SUBJECT

TO BENEFIT-SHARING, REGARDLESS OF WHO PREVIOUSLY

PERFORMED THE ACCESS

www.fiocruz.br

BENEFIT SHARING

CLEAR AND FIXED RULES FOR BENEFIT SHARING WERE ESTABLISHED

THAT CAN BE:

• MONETARY, WITH THE PERCENTAGE OF 1% OF ANNUAL NET REVENUE OR UP TO

0.1% BY SECTORIAL AGREEMENT, OR

• NON MONETARY

a. projects for conservation, sustainable use of biodiversity, protection and maintenance

of knowledge, innovations and practices of populations holders of traditional

knowledge

b. technology transfer

c. training of human resources on issues related to conservation and sustainable use of

genetic heritage or associated traditional knowledge

d. free distribution of products in programs of social interest, etc…

www.fiocruz.br

Associated TK of

identifiable source

Is the Government,

represented by the

Ministry of the

Environment

Are the indigenous

people, traditional

communities and

traditional farmers

BENEFIT SHARING

The beneficiary of benefit sharing:

The beneficiary of benefit sharing:

IN THE CASE OF ACCESS TO:

Genetic Heritage and

Associated TK of

unidentifiable source

www.fiocruz.br

THE PAYMENTS FROM THE BENEFIT SHARING AND FINES DUE TO NON-

COMPLIANCE OF THE LAW SHALL BE DEPOSITED IN

BENEFIT SHARING

THE NATIONAL FUND FOR BENEFIT SHARING - FNRB

ESTABLISHED FOR VALORIZING GENETIC HERITAGE AND ASSOCIATED

TRADITIONAL KNOWLEDGE AS WELL AS TO PROMOTE THEIR USE IN A

SUSTAINABLE WAY

www.fiocruz.br

Associated TraditionalKnowledge ofunidentifiable source

Associated TraditionalKnowledge ofidentifiable source

The payments will goentirely to the FNRB

The TK holders negotiate freely the benefitsharing and additional 0.5% of annual netrevenue from the economic exploitation ofthe knowledge will go to the FNRB and willbe administered by providers

Genetic HeritageThe payments will goentirely to the FNRB

BENEFIT SHARING

WHEN THE BENEFIT SHARING COMES FROM:

www.fiocruz.br

Genetic Heritage from ex

situ Collections

Associated Traditional

Knowledge

Will be partially (60 to 80%)

intended for the benefit of

these collections

Will be used exclusively for the

benefit of traditional knowledge

holders

BENEFIT SHARING

THE MONETARY FUNDS DEPOSITED IN THE NATIONAL FUND OF BENEFIT

SHARING (FNRB) ARISING FROM ECONOMIC EXPLOITATION OF FINISHED

PRODUCT OR REPRODUCTIVE MATERIAL OBTAINED FROM THE ACCESS TO:

www.fiocruz.br

• Conservation of biological diversity

• Survey and inventory of genetic resources

• Recovery, creation and maintenance of ex situ collections

• Training of human resources associated with the use and conservation

of genetic heritage and associated traditional knowledge

• Promotion of research and technological development associated with

genetic heritage and associated traditional knowledge

BENEFIT SHARING

Through the National Fund of Benefit Sharing the National Program of

Benefit Sharing – PNRB will be established in order to promote, among

others:

www.fiocruz.br

CGEN CREATED ELECTRONIC SYSTEM

ACCREDITATIONNATIONAL INSTITUTIONS MAINTAINING ex situCOLLECTIONS THAT HOLD GENETIC HERITAGE

The National System for Genetic Heritage and Associated Traditional

Knowledge Management (SisGen) was created to manage:

NOTIFICATIONFINISHED PRODUCT

REPRODUCTIVE MATERIAL

AUTHORIZATION

ACCESS TO GENETIC HERITAGE


SHIPPING GENETIC HERITAGE

REGISTRATION



SHIPPING GENETIC HERITAGE

SENDING GENETIC HERITAGE

www.fiocruz.br

NATIONAL SYSTEM FOR GENETIC HERITAGE AND ASSOCIATED TRADITIONAL KNOWLEDGE MANAGEMENT

www.fiocruz.br


REGISTRATION OF THE ACCESS ACTIVITY

www.fiocruz.br



www.fiocruz.br



www.fiocruz.br

RESEARCH INFORMATION


www.fiocruz.br


ABOUT THE GENETIC HERITAGE

ACCESSED

www.fiocruz.br



SOURCE

www.fiocruz.br

REGISTRATION OF THE

SENDING


www.fiocruz.br

REGISTRATION OF THE

SENDING


www.fiocruz.br

REGISTRATION OF THE

SHIPMENT ABROAD


www.fiocruz.br

REGISTRATION OF THE

SHIPMENT ABROAD


www.fiocruz.br


TO BE SHIPPED ABROAD


www.fiocruz.br




www.fiocruz.br




www.fiocruz.br




www.fiocruz.br

RECIPIENT INSTITUTION


www.fiocruz.br


NOTIFICATION

OF PRODUCT

www.fiocruz.br


NOTIFICATION

OF PRODUCT

www.fiocruz.br


REGISTRATION OF EX SITU

COLLECTION

www.fiocruz.br


INFORMATION ON THE SAMPLE

PRESERVED IN THE COLLECTION

www.fiocruz.br


INFORMATION ON THE

COLLECTION CURATOR

www.fiocruz.br

DOCUMENT THAT PROVES THAT

THE USER PROVIDED THE

REQUESTED INFORMATION AND

PRODUCES THE FOLLOWING

EFFECTS:

AFTER FINALIZING

THE REGISTRATION

OR NOTIFICATION

ESTABLISHES THE

VERIFICATION

PROCEDURE

ENABLES

A RECEIPT WILL BE

ISSUED

AUTOMATICALLY

THE USER DO NOT NEED TO WAIT FOR THE VERIFICATION CONCLUSION TO PERFORM THE ABOVE ACTIVITIES

commercialization of the intermediate product

request of any intellectual property right

dissemination of results from research or TD

notification

shipment abroad

economic exploitation

REGISTRATION OF ACCESS TO GH

REGISTRATION OF ACCESS TO ATK

REGISTRATION OF GH SHIPMENT

NOTIFICATION


www.fiocruz.br

COMPLY WITH THE REQUIREMENTS OF THE

LAW

ADMINISTRATIVE ACT BY

WHICH THE COMPETENT

AUTHORITY DECLARES THAT

ACCESS TO ASSOCIATED

TRADITIONAL KNOWLEDGE


CERTIFICATE OF ACCESS

REGULARITY

CERTIFICATE OF ACCESS REGULARITY

UPON REQUEST OF THE USER AND

AFTER DETERMINATION OF CGEN WILL

BE ISSUED

PREVENTS APPLICATION OF ADMINISTRATIVE PENALTIES SPECIFICALLY

REGARDING ACCESS ACTIVITIES UNDERTAKEN UNTIL ISSUING THE CERTIFICATE

www.fiocruz.br

FOR COMPLYING WITH THE LAW: RESEARCH AND TECHNOLOGICAL DEVELOPMENT

RECEIPT

AUTOMATICALLY

ISSUED

REGISTRATIONRESEARCH AND TD

WITH THE

BRAZILIAN GH

INDICATE THESOURCE OF THE GH:IN SITU; EX SITUOR/AND IN SILICO

www.fiocruz.br


RECEIPT

AUTOMATICALLY

ISSUED


WITH THE

BRAZILIAN GH


www.fiocruz.br


DEPOSIT IN COLLECTION IS RECOMENDED

SHIPPING GH ABROAD

SIGNATURE OF A MATERIAL TRANSFER

AGREEMENT

RECEIPT

AUTOMATICALLY

ISSUED

BOTH DOCUMENTS GO ALONG WITH

THE GH

REGISTRATION PRIOR SHIPPING

GH ABROAD

RECEIPT

AUTOMATICALLY

ISSUED


WITH THE

BRAZILIAN GH


www.fiocruz.br


RECEIPT

AUTOMATICALLY

ISSUED


WITH THE

BRAZILIAN GH


SENDING GHSIGNATURE OF A

LEGAL INSTRUMENT

THIS DOCUMENT GOES ALONG WITH

THE GH

REGISTRATION FOR SENDING THE GH

ABROAD

www.fiocruz.br


RECEIPT

AUTOMATICALLY

ISSUED


WITH THE

BRAZILIAN GH


WHEN THE SENDING

IS FOR GENETIC

SEQUENCING

THERE IS NO NEED OF A LEGAL

INSTRUMENT, JUST A FORMAL

COMMUNICATION OF THE INSTITUTION

ABOUT THE OBLIGATIONS AND

PROHIBITIONS

SENDING GHREGISTRATION FOR

SENDING THE GH ABROAD

www.fiocruz.br

RECEIPT

AUTOMATICALLY

ISSUED


WITH THE

BRAZILIAN GH


ACCESS TO

ASSOCIATED

TRADITIONAL

KNOWLED

REGISTRATION

OBTAINING PREVIUS

INFORMED CONSENT –

PIC (identifiable ATK)

BEORE ACCESS

RECEIPT

AUTOMATICALLY

ISSUED

FOR COMPLYING WITH THE LAW: ACCESS TO GR AND ATK

www.fiocruz.br

RECEIPT

AUTOMATICALLY

ISSUED


WITH THE

BRAZILIAN GH


FOR COMPLYING WITH THE LAW: ECONOMICAL EXPLORATION

SIGNATURE OF A BENEFIT SHARING

AGREEMENT

FINISHED

PRODUCTS

DEVELOPED FROM

BRAZILIAN GH

NOTIFICATION PRIOR ECONOMIC

EXPLORATION

RECEIPT

AUTOMATICALLY

ISSUED

ECONOMIC EXPLORATION

WHEN MONETARY IS WITH THE GOVERNMENT AND

TRADITIONAL COMMUNITY IF THERE IS IDENTIFIABLE ATK

BENEFIT SHARING CAN BE

MONETARY OR NON-MONETARY

www.fiocruz.br

RESEARCH


Establishment of more flexible rules for the regularization of liabilities arising

from non-compliance with the Provisional Measure 2.186 / 2001. All sanctions

were extinguished, with the exception of fines

100% exemption from fine payment

The regularization is conditional upon signature of a commitment term, but

only for development. In the case of research, the user will be regularized by

means of registration

REGULARIZATION REGARDING THE PROVISIONAL MEASURE 2.186/2001

www.fiocruz.br

RESEARCH


Establishment of more flexible rules for the regularization of liabilities arising

from non-compliance with the Provisional Measure 2.186 / 2001. All sanctions

were extinguished, with the exception of fines

100% exemption from fine payment

REGULARIZATION REGARDING THE PROVISIONAL MEASURE 2.186/2001

THE PERIOD FOR REGULARIZATION IS ONE YEAR AFTER THE ELECTRONIC SYSTEM IS

MADE AVAILABLE

www.fiocruz.br

VIOLATIONS AGAINST GH AND ATK

• Explore economically finished product or reproductive material from access to GH or ATK withoutnotification

• Shipping GH abroad without prior registration or in disagreement with this

• Disseminate results, final or partial, in scientific or communication circles without prior registration

• Access ATK of identifiable source without obtaining prior informed consent or in disagreement with this

• Failing to indicate the origin of ATK of identifiable source in publications, utilizations, explorations anddisclosures of results from the access

THOSE WHO FAIL TO MEET THE REQUIREMENTS OF THE LAW REGARDING ACCESS TO GENETIC

RESOURCES AND TRADITIONAL KNOWLEDGE, INCLUDING, AMONG OTHERS:

• Warning

• Fine

• Suspension of certificate

• Cancellation of certificate

• Embargo on the specific activity related to the offense

• Apprehension of materials

• Temporary suspension of the manufacture and sale of the finished product or reproductive materials

• Partial or total prohibition of the establishment, activity or enterprise

CAN BE PUNISHED WITH PENALTIES SUCH AS:

www.fiocruz.br

VIOLATIONS AGAINST GH AND ATK

• Explore economically finished product or reproductive material from access to GH or ATK withoutnotification

• Shipping GH abroad without prior registration or in disagreement with this

• Disseminate results, final or partial, in scientific or communication circles without prior registration

• Access ATK of identifiable source without obtaining prior informed consent or in disagreement with this

• Failing to indicate the origin of ATK of identifiable source in publications, utilizations, explorations anddisclosures of results from the access

THOSE WHO FAIL TO MEET THE REQUIREMENTS OF THE LAW REGARDING ACCESS TO GENETIC

RESOURCES AND TRADITIONAL KNOWLEDGE, INCLUDING, AMONG OTHERS:

CAN BE PUNISHED WITH PENALTIES SUCH AS:

• Fines

From R $ 1,000.00 to R $ 100,000.00, when the infraction is committed by an

individual

From R $ 10,000.00 to R $ 10,000,000.00, when the infraction is committed by a legal

entity

www.fiocruz.br

www.fiocruz.br

www.fiocruz.br

THANK YOU!

Manuela da [email protected]

FIOCRUZ

FUNDAÇÃO OSWALDO CRUZ

HEALTH MINISTRY

THE BRAZILIAN LEGISLATION ON ACCESS AND ...... LAW Nº 13.123, FROM 20 OF MAI 2015 THE NEW BRAZILIAN ABS LEGISLATION DECREE Nº 8.772, FROM 11 OF MAY 2016 Regulates Law No. 13,123,

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