OVERVIEW OF BRAZILIAN LEGISLATION ON ACCESS BENEFIT SHARING
MANUELA DA SILVA - FIOCRUZ – OSWALDO CRUZ FOUNDATION – BRAZIL
www.fiocruz.br

THE NEW BRAZILIAN ABS LEGISLATION

The law was published on May
21, 2015 and entered into force
on November 17, 2015

After almost 6 months since thelaw came into force, the Decree
regulating it was publishedwww.fiocruz.br

LAW Nº 13.123, FROM 20 OF MAI 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 15and §§ 3 and 4 of Article 16 of the Convention on Biological Diversity,
promulgated by Decree No. 2519 of 16 March 1998, provides for access togenetic 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, andtakes other measures.

DECREE Nº 8.772, FROM 11 OF MAY 2016

Regulates Law No. 13,123, of May 20, 2015, which provides for access togenetic resources, the protection and access to associated traditional
knowledge and the sharing of benefits for conservation and sustainable
use of biodiversity.

ABS NATIONAL COMPETENT AUTHORITY
The Brazilian ABS National Competent Authority is the Genetic Heritage Management
Council - CGen

CGen will consist of representatives from bodies and entities of the federal public
administration that are competent on the various actions of this law with maximum
participation of 60% and the representation of civil society in at least 40% of themembers.
Based on the Decree, there will be 11 Ministries and 9 representatives of civilsociety, 3 of each of the following sectors:• Business sector• Academia• Indigenous peoples, traditional communities and traditional farmers

www.fiocruz.br

SCOPE OF THE LAW 13.123/15• RESEARCH

THE LAW• TECHNOLOGICAL DEVELOPMENTACCESS = UTILIZATION

COVERS THE
ACTIVITY OF• ECONOMIC EXPLOITATION• FINISHED PRODUCT OR

ORIGINATED FROM THE
ACCESS OF GENETICHERITAGE• REPRODUCTIVE MATERIAL

THIS IS THE MOMENT WHEN THERE IS
BENEFIT SHARING
www.fiocruz.br

ORIGINATED FROM THE
ACCESS OF ASSOCIATED
TRADITIONAL KNOWLEDGE

ECONOMIC EXPLOITATIONFINISHED PRODUCTProduct whose nature does not require any additional production process,arising from access to genetic heritage or associated traditional knowledge, inwhich 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

REPRODUCTIVE MATERIAL

It refers to plant propagation material or animal reproduction of any genus,
species or cultivation from sexual or asexual reproductionwww.fiocruz.br

SCOPE OF THE LAW 13.123/15
DIFERENTLY FROM THE PREVIOUS LEGISLATION, THE NEW LAW:

REACHES ALL RESEARCH(EXPERIMENTAL OR
THEORETICAL) CONDUCTEDWITH THE BRAZILIANGENETIC HERITAGE

www.fiocruz.br

DEFINITION

information of genetic origin fromplants, animals, microorganisms orspecies of other nature, including
substances
derivedfromthemetabolism of these living beings

SCOPE OF THE LAW 13.123/15
DIFERENTLY FROM THE PREVIOUS LEGISLATION, THE NEW LAW:

REACHES ALL RESEARCH(EXPERIMENTAL OR
THEORETICAL) CONDUCTEDWITH THE BRAZILIANGENETIC HERITAGE

DEFINITION

information of genetic origin fromplants, animals, microorganisms orspecies of other nature, including
substances
derivedfromthemetabolism of these living beings

BASIC RESEARCH SUCH AS:

www.fiocruz.br•

EPIDEMIOLOGY•

MOLECULAR ECOLOGY•

MOLECULAR TAXONOMY•PHYLOGENYSCOPE OF THE LAW 13.123/15
DIFERENTLY FROM THE PREVIOUS LEGISLATION, THE NEW LAW:

REACHES ALL RESEARCH(EXPERIMENTAL OR
THEORETICAL) CONDUCTEDWITH THE BRAZILIANGENETIC HERITAGE

USE

DEFINITION

OF

information of genetic origin fromplants, animals, microorganisms orspecies of other nature, including
substances
derivedfromthemetabolism of these living beings

INFORMATIONFROMGENETIC SEQUENCES PUBLISHED IN
PUBLIC DATA BASES (GenBank)

www.fiocruz.br

SCOPE OF THE LAW 13.123/15
OTHER NOVELTY IN THE LAW IS THE PARAGRAPH ON MICROORGANISMS

The microorganism that has
been isolated from

National territory
substrates

Territorial sea

Exclusive
economic zone

is considered Brazilian genetic resource for the
purposes of this law

www.fiocruz.br

Continental shelf

ACTIVITIES THAT ARE SUBJECT TO THE LAW

I.

Access to genetic heritage and associated traditional
knowledge;

II. Shipment abroad of genetic heritageIII. Economic exploitation of finished product or reproductive
material from access to genetic heritage and associatedtraditional knowledge

www.fiocruz.br

FOR COMPLYING WITH THE LAWRESEARCHREGISTRATIONTECHNOLOGICAL DEVELOPMENTNOTIFICATION BEFORE

www.fiocruz.br

ECONOMIC EXPLOITATIONFOR COMPLYING WITH THE LAWRESEARCHREGISTRATIONTECHNOLOGICAL DEVELOPMENT

THE REGISTRATION SHOULD BE CONDUCTED PRIOR TO:
•
•
•
•
•

Shipment abroad
Request of any intellectual property rightCommercialization of any intermediate productRelease of results, final or partial, in scientific or communication circles
Notification of finished product or reproductive material developed as aresult of the accesswww.fiocruz.br

NOTIFICATION

www.fiocruz.br

NOTIFICATION

For economic exploitation will be required:I.

prior notification of the finished product or the reproductive
material to CGenII.

presentation of the benefit-sharing agreement (BSA) within 1
year from the time of notification, except in the case offinished product or reproductive material from access to ATK
of identifiable origin. In this case, the agreement must bepresented at the time of notificationwww.fiocruz.br

AUTHORIZATIONTHE 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
The authorization will be required only in cases where there is some involvement offoreigners:
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 abroadwww.fiocruz.br

ACCESS TO ASSOCIATED TRADITIONAL KNOWLEDGE
THE TRADITIONAL KNOWLEDGE ASSOCIATED TO GENETIC HERITAGE
CAN BE RECOGNIZED IN SCIENTIFIC PUBLICATIONS, RECORDS IN

KNOWLEDGE

ASSOCIATED TRADITIONALREGISTERS OR DATABASES AND CULTURAL INVENTORIES

www.fiocruz.br

OF IDENTIFIABLE
SOURCE

WHEN THERE IS

THE POSSIBILITY OF LINKING ITS
SOURCETO

INDIGENOUS
OF
UNIDENTIFIABLE
SOURCE

AT

LEAST

AN

POPULATION,

TRADITIONAL COMMUNITY OR
WHEN THERE IS NOTTRADITIONAL FARMERACCESS TO ASSOCIATED TRADITIONAL KNOWLEDGE
ANY INDIGENOUS POPULATION, TRADITIONAL COMMUNITY OR
TRADITIONAL FARMER WHO CREATES, DEVELOPS, HOLDS ORPRESERVES CERTAIN TRADITIONAL KNOWLEDGE IS AN IDENTIFIABLE

KNOWLEDGE

ASSOCIATED TRADITIONAL

SOURCE OF SUCH KNOWLEDGE

www.fiocruz.br

OF IDENTIFIABLE
SOURCE

WHEN THERE IS

THE POSSIBILITY OF LINKING ITS
SOURCETO

INDIGENOUS
OF
UNIDENTIFIABLE
SOURCE

AT

LEAST

AN

POPULATION,

TRADITIONAL COMMUNITY OR
WHEN THERE IS NOTTRADITIONAL FARMERACCESS TO ASSOCIATED TRADITIONAL KNOWLEDGE

THE ACCESS TO THIS KNOWLEDGE IS SUBJECT TO

KNOWLEDGE

ASSOCIATED TRADITIONALOBTAINING PREVIUS INFORMED CONSENT - PIC

www.fiocruz.br

OF IDENTIFIABLE
SOURCE

WHEN THERE IS

THE POSSIBILITY OF LINKING ITS
SOURCETO

INDIGENOUS
OF
UNIDENTIFIABLE
SOURCE

AT

LEAST

AN

POPULATION,

TRADITIONAL COMMUNITY OR
WHEN THERE IS NOTTRADITIONAL FARMERSHIPMENT ABROAD OF GENETIC HERITAGE
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 RECEPIENTINSTITUTION

SHIPMENT ABROAD WILL HAVE TO BE REGISTERED IN CASES WHERE ACCESSTO 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

www.fiocruz.br

SHIPMENT ABROAD OF GENETIC HERITAGE
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 RECEPIENTINSTITUTIONREGISTRATION FOR SHIPMENT ABROAD MUST BE PERFORMED PRIORSHIPMENT AND DEPENDS ON:•

THE SIGNATURE OF MATERIAL TRANSFER AGREEMENT – MTA•

THE SUPLY OF INFORMATION ABOUT THE PROVIDERINSTITUTIONS, GENETIC HERITAGE AND INTENDED USE

www.fiocruz.br

AND RECIPEINTMATERIAL TRANSFER AGREEMENTThe 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

www.fiocruz.br

MATERIAL TRANSFER AGREEMENTThe 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
In the case of authorization, the transfer of genetic heritage to third parties
will also depend on a MTA containing the above requirements. Thisobligation will be applied to all subsequent transfers

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

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 TRASFEREDSERVICES PROVIDEDABROAD ARE CONSIDEREDTESTS
SPECILIZED TECHNIQUESPERFORMED BY AN INSTITUTION COLABORATING WITH THE NATIONALINSTITUTION RESPONSIBLE BY THE ACCESS OR BY WHICH IT WAS HIRED

www.fiocruz.br

RESEARCH BY FOREIGNERS
BRAZILIAN BIODIVERSITY CAN ONLY BE ACCESSED BY
FOREIGN INSTITUTION(LEGAL ENTITY LOCATEDABROAD)in partnership withBRAZILIAN INSTITUTION(PUBLIC OR PRIVATE)THAT WILL BE RESPONSIBLE FOR THE REGISTRATIONAND UPDATING SisGen (REGISTRY, NOTIFICATION,
BENEFIT SHARING PAYMENT)NATIONAL COUNCIL FORSCIENTIFIC AND TECHNOLOGICALDEVELOPMENT

If access occurs in Brazil, an Authorization'sRequest for Collecting and Research(Scientific Expeditions) has to be obtained
from the Brazilian Institution for the Foreign
Institution before the Registration in SisGen

www.fiocruz.br

BENEFIT SHARING
CLEAR AND FIXED RULES FOR BENEFIT SHARING WERE ESTABLISHEDTHAT CAN BE:• MONETARY, WITH THE PERCENTAGE OF 1% OF ANNUAL NET REVENUE OR UP TO
0.1% BY SECTORIAL AGREEMENT, OR• NON MONETARYONLY THE MANUFACTURER OF THE FINISHED PRODUCT OR THE
PRODUCER OF THE REPRODUCTIVE MATERIAL WILL BE SUBJECTTO BENEFIT-SHARING, REGARDLESS OF WHO PREVIOUSLYPERFORMED THE ACCESS

www.fiocruz.br

BENEFIT SHARING
CLEAR AND FIXED RULES FOR BENEFIT SHARING WERE ESTABLISHEDTHAT 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 maintenanceof knowledge, innovations and practices of populations holders of traditional
knowledgeb. technology transfer
c. training of human resources on issues related to conservation and sustainable use ofgenetic heritage or associated traditional knowledge
d. free distribution of products in programs of social interest, etc…

www.fiocruz.br

BENEFIT SHARING
IN THE CASE OF ACCESS TO:

Genetic Heritage andAssociated TK of
unidentifiable source

Associated TK ofidentifiable source

www.fiocruz.br

The beneficiary of
benefit sharing:

Is the Government,
represented by the
MinistryoftheEnvironment

The beneficiary of
benefit sharing:

Are the indigenous
people, traditional
communities
andtraditional farmers

BENEFIT SHARING
THE PAYMENTS FROM THE BENEFIT SHARING AND FINES DUE TO NONCOMPLIANCE OF THE LAW SHALL BE DEPOSITED IN

THE NATIONAL FUND FOR BENEFIT SHARING - FNRBESTABLISHED FOR VALORIZING GENETIC HERITAGE AND ASSOCIATED
TRADITIONAL KNOWLEDGE AS WELL AS TO PROMOTE THEIR USE IN ASUSTAINABLE WAY

www.fiocruz.br

BENEFIT SHARING
WHEN THE BENEFIT SHARING COMES FROM:

Genetic Heritage

The payments will
entirely to the FNRB

goAssociated Traditional
Knowledgeofunidentifiable source

The payments will
entirely to the FNRB

goAssociated Traditional
Knowledgeofidentifiable source

The TK holders negotiate freely the benefit
sharing and additional 0.5% of annual net
revenue from the economic exploitation of
the knowledge will go to the FNRB and will
be administered by providers

www.fiocruz.br

BENEFIT SHARING
THE MONETARY FUNDS DEPOSITED IN THE NATIONAL FUND OF BENEFITSHARING (FNRB) ARISING FROM ECONOMIC EXPLOITATION OF FINISHEDPRODUCT OR REPRODUCTIVE MATERIAL OBTAINED FROM THE ACCESS TO:

Genetic Heritage from exsitu Collections

AssociatedKnowledge

www.fiocruz.br

Traditional

Will be partially (60 to 80%)
intended for the benefit ofthese collections

Will be used exclusively for the

benefit of traditional knowledge
holders

BENEFIT SHARING
Through the National Fund of Benefit Sharing the National Program ofBenefit Sharing – PNRB will be established in order to promote, among
others:• Conservation of biological diversity• Survey and inventory of genetic heritage• Recovery, creation and maintenance of ex situ collections• Training of human heritage associated with the use and conservation ofgenetic heritage and associated traditional knowledge• Support for the efforts of indigenous peoples, traditional communities andtraditional farmers in the sustainable management and conservation ofgenetic heritagewww.fiocruz.br

CGEN CREATED ELECTRONIC SYSTEMThe National System for Genetic Heritage and Associated Traditional
Knowledge Management (SisGen) was created to manage:ACCESS TO GENETIC HERITAGEACCESS TO ASSOCIATED TRADITIONAL KNOWLEDGE

REGISTRATIONSHIPPING GENETIC HERITAGE
SENDING GENETIC HERITAGENOTIFICATIONFINISHED PRODUCTREPRODUCTIVE MATERIALACCESS TO GENETIC HERITAGE

AUTHORIZATIONACCESS TO ASSOCIATED TRADITIONAL KNOWLEDGE
SHIPPING GENETIC HERITAGE

ACCREDITATION

www.fiocruz.br

NATIONAL INSTITUTIONS MAINTAINING ex
COLLECTIONS THAT HOLD GENETIC HERITAGE

situ

ELECTRONIC SYSTEM FOR REGISTRATION

www.fiocruz.br

ELECTRONIC SYSTEM FOR REGISTRATIONREGISTRATION OF THE INSTITUTION

www.fiocruz.br

ELECTRONIC SYSTEM FOR REGISTRATIONREGISTRATION OF THE INSTITUTION

www.fiocruz.br

REGISTRATION OF THE USERELECTRONIC SYSTEM FOR REGISTRATIONREGISTRATION OF THE ACCESS ACTIVITY

www.fiocruz.br

ELECTRONIC SYSTEM FOR REGISTRATIONREGISTRATION OF THE ACCESS ACTIVITY

www.fiocruz.br

ELECTRONIC SYSTEM FOR REGISTRATIONREGISTRATION OF THE ACCESS ACTIVITY

www.fiocruz.br

ELECTRONIC SYSTEM FOR REGISTRATIONREGISTRATION OF THE ACCESS ACTIVITY

www.fiocruz.br

ABOUT THE GENETIC HERITAGE SOURCEELECTRONIC SYSTEM FOR REGISTRATIONREGISTRATION OF THE ACCESS ACTIVITY

www.fiocruz.br

ABOUT THE GENETIC HERITAGE SOURCEELECTRONIC SYSTEM FOR REGISTRATIONREGISTRATION OF THE ACCESS ACTIVITY

www.fiocruz.br

ABOUT THE GENETIC HERITAGE SOURCEELECTRONIC SYSTEM FOR REGISTRATIONREGISTRATION OF THE SHIPMENT ABROAD

www.fiocruz.br

ELECTRONIC SYSTEM FOR REGISTRATIONREGISTRATION OF THE SHIPMENT ABROADPROVIDER INSTITUTION

www.fiocruz.br

ELECTRONIC SYSTEM FOR REGISTRATIONREGISTRATION OF THE SHIPMENT ABROADPROVIDER INSTITUTION

RECIPIENT INSTITUTION

www.fiocruz.br

ELECTRONIC SYSTEM FOR REGISTRATIONREGISTRATION OF THE SHIPMENT ABROADDEPOSIT IN EX SITU COLLLECTION

www.fiocruz.br

ELECTRONIC SYSTEM FOR REGISTRATIONREGISTRATION OF THE SHIPMENT ABROAD

www.fiocruz.br

REGISTRATION OF THE SENDING ABROAD

ELECTRONIC SYSTEM FOR NOTIFICATIONNOTIFICATION OF PRODUCT

www.fiocruz.br

ELECTRONIC SYSTEM FOR REGISTRATION AND NOTIFICATIONREGISTRATION OF ACCESS TO GH

AFTER FINALIZINGA RECEIPT WILL BE

THE REGISTRATIONISSUED

OR NOTIFICATIONAUTOMATICALLYREGISTRATION OF ACCESS TO ATKREGISTRATION OF GH SHIPMENTNOTIFICATIONDOCUMENT THAT PROVES THATTHE USER PROVIDED THE
REQUESTED INFORMATION AND
PRODUCES THE FOLLOWINGEFFECTS:request of any intellectual property rightcommercialization of the intermediate productdissemination of results from research or TD

ENABLES

notification
shipment abroad

ESTABLISHES THE
VERIFICATIONPROCEDURE

www.fiocruz.br

economic exploitation
THE USER DO NOT NEED TO WAIT FOR THE VERIFICATION CONCLUSION
TO PERFORM THE ABOVE ACTIVITIESCERTIFICATE OF ACCESS REGULARITY
UPON REQUEST OF THE USER AND
AFTER DETERMINATION OF CGEN WILL
BE ISSUEDCERTIFICATE OF ACCESSREGULARITY

ADMINISTRATIVE ACT BY
WHICH THE COMPETENTAUTHORITY DECLARES THATACCESS TO GENETIC HERITAGEACCESS TO ASSOCIATEDCOMPLY WITH THE
REQUIREMENTS OF THE
LAW

TRADITIONAL KNOWLEDGE

PREVENTS APPLICATION OF ADMINISTRATIVE PENALTIES SPECIFICALLYREGARDING ACCESS ACTIVITIES UNDERTAKEN UNTIL ISSUING THE CERTIFICATE

www.fiocruz.br

FOR COMPLYING WITH THE LAW: RESEARCH AND TECHNOLOGICAL DEVELOPMENTRESEARCH AND TD
WITH THEBRAZILIAN GH

www.fiocruz.br

REGISTRATION

INDICATE
THE
SOURCE OF THE GH:
IN SITU; EX SITU
OR/AND IN SILICORECEIPT
AUTOMATICALLYISSUEDFOR COMPLYING WITH THE LAW: RESEARCH AND TECHNOLOGICAL DEVELOPMENTRESEARCH AND TD
WITH THEBRAZILIAN GH

www.fiocruz.br

REGISTRATION

INDICATE
THE
SOURCE OF THE GH:
IN SITU; EX SITU
OR/AND IN SILICORECEIPT
AUTOMATICALLYISSUEDFOR COMPLYING WITH THE LAW: RESEARCH AND TECHNOLOGICAL DEVELOPMENTRESEARCH AND TD
WITH THEBRAZILIAN GH

SHIPPING GH
ABROADREGISTRATIONREGISTRATIONPRIOR SHIPPING
GH ABROAD

INDICATE
THE
SOURCE OF THE GH:
IN SITU; EX SITU
OR/AND IN SILICOSIGNATURE OF
A MATERIAL
TRANSFER
AGREEMENTRECEIPT
AUTOMATICALLYISSUEDRECEIPT
AUTOMATICALLYISSUEDDEPOSIT IN
COLLECTION IS
RECOMENDED

BOTH DOCUMENTS
GO ALONG WITH
THE GH

www.fiocruz.br

FOR COMPLYING WITH THE LAW: RESEARCH AND TECHNOLOGICAL DEVELOPMENTRESEARCH AND TD
WITH THEBRAZILIAN GH

SENDING GH

REGISTRATIONREGISTRATION FOR
SENDING THE GH
ABROAD

INDICATE
THE
SOURCE OF THE GH:
IN SITU; EX SITU
OR/AND IN SILICORECEIPT
AUTOMATICALLYISSUED

SIGNATURE OF ALEGALINSTRUMENT

THIS DOCUMENT
GOES ALONG WITH
THE GH

www.fiocruz.br

FOR COMPLYING WITH THE LAW: RESEARCH AND TECHNOLOGICAL DEVELOPMENTRESEARCH AND TD
WITH THEBRAZILIAN GH

SENDING GH

www.fiocruz.br

REGISTRATIONREGISTRATION FOR
SENDING THE GH
ABROAD

INDICATE
THE
SOURCE OF THE GH:
IN SITU; EX SITU
OR/AND IN SILICOWHEN THE SENDING
IS FOR GENETIC
SEQUENCING

RECEIPT
AUTOMATICALLYISSUED

THERE IS NO NEED OF A LEGALINSTRUMENT, JUST A FORMALCOMMUNICATION OF THE INSTITUTIONABOUT THE OBLIGATIONS AND
PROHIBITIONSFOR COMPLYING WITH THE LAW: ACCESS TO GH AND ATKRESEARCH AND TD
WITH THEBRAZILIAN GH

ACCESS TO
ASSOCIATED
TRADITIONALKNOWLED

www.fiocruz.br

REGISTRATIONOBTAINING PREVIUS
INFORMED CONSENT –PIC (identifiable ATK)BEFORE ACCESSINDICATE
THE
SOURCE OF THE GH:
IN SITU; EX SITU
OR/AND IN SILICORECEIPT
AUTOMATICALLYISSUEDRECEIPTREGISTRATIONAUTOMATICALLYISSUEDFOR COMPLYING WITH THE LAW: ECONOMICAL EXPLORATIONRESEARCH AND TD
WITH THEBRAZILIAN GH

REGISTRATIONFINISHEDPRODUCTSDEVELOPED FROMBRAZILIAN GH

NOTIFICATIONPRIOR ECONOMICEXPLORATION

INDICATE
THE
SOURCE OF THE GH:
IN SITU; EX SITU
OR/AND IN SILICORECEIPT
AUTOMATICALLYISSUEDRECEIPT
AUTOMATICALLYISSUEDECONOMICEXPLORATION

SIGNATURE OF A
BENEFIT SHARING
AGREEMENT

www.fiocruz.br

BENEFIT SHARINGCAN BEMONETARY OR
NON-MONETARY

WHEN MONETARY IS WITH
THE GOVERNMENT AND
TRADITIONAL COMMUNITY IF
THERE IS IDENTIFIABLE ATKREGULARIZATION
Flexible rules were established for the regularization of the liability resulting
from the failure to comply with the Provisional Act 2.186/2001. All the
penalties were extinguished, with the exception of fines

RESEARCH

90% fine exemption
TECHNOLOGICAL DEVELOPMENT

with the remaining balance with the possibility
to be reversed, for instance, conservation
projects, in the distribution of products inprograms of social interest

www.fiocruz.br

REGULARIZATION
Flexible rules were established for the regularization of the liability resulting
from the failure to comply with the Provisional Act 2.186/2001. All the
penalties were extinguished, with the exception of fines

RESEARCH

90% fine exemption
TECHNOLOGICAL DEVELOPMENT

with the remaining balance with the possibility
The regularization tois beconditioned
to instance,
the signatureof areversed, forconservation
Commitment
projects, inAgreement
the distribution of products inprograms of social interest

www.fiocruz.br

REGULARIZATION
Flexible rules were established for the regularization of the liability resulting
from the failure to comply with the Provisional Act 2.186/2001. All the
penalties were extinguished, with the exception of fines

RESEARCH

90% fine exemption
TECHNOLOGICAL DEVELOPMENT

In the case of access to genetic heritage or associated TK for research
The regularization is conditioned to the signature of apurposes, the user will be exempted from signing the Commitment
Commitment Agreement
Agreement, regularizing through the registrationwww.fiocruz.br

VIOLATIONS AGAINST GH AND ATK
THOSE WHO FAIL TO MEET THE REQUIREMENTS OF THE LAW REGARDING ACCESS TO GENETICRESOURCES AND TRADITIONAL KNOWLEDGE, INCLUDING, AMONG OTHERS:
•
•
•
•
•

Explore economically finished product or reproductive material from access to GH or ATK without
notification
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 thisFailing to indicate the origin of ATK of identifiable source in publications, utilizations, explorations anddisclosures of results from the access

CAN BE PUNISHED WITH PENALTIES SUCH AS:
•
•
•
•
•
•
•
•

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 enterprisewww.fiocruz.br

THANK YOU!
Manuela da Silva
manuela.dasilva@fiocruz.br
FIOCRUZFUNDAÇÃO OSWALDO CRUZHEALTH MINISTRY

www.fiocruz.br