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NAGOYA
PROTOCOL
Nagoya Protocol
Nagoya Protocol
The Nagoya Protocol creates incentives to conserve and sustainably use genetic
resources, and therefor enhances the contribution of biodiversity to development and
human well-being.
Nagoya Protocol
Nagoya Protocol
2016 - May, 26th
Signatories
92
Parties
76
Nagoya Protocol
Nagoya Protocol
Nagoya Protocol
CGEN
CGEN
REGULATIONS IN BRAZIL
 Provisional Act nº 2.186-16/2001
 Regulated by Decrees nº 3.945/2001, 4.946/2003 and 5.459/2005
 Resolutions, Technical Orientations and CGEN’s deliberations (Genetic Heritage Governing Council)
Provisional Act nº 2.186-16/2001
 Access to components of genetic heritage existing within the Brazilian territory
 Access and protection of traditional knowledge associated to genetic heritage
 Fair and equitable sharing of benefits
 Access to technology and transfer of technology for the conservation and use of biological diversity
Still pending in the Federal Government a bill, as an alternative to this Provisional Act, there is not a deadline to be presented to Congress.
CGEN
Elaboration of documents
Request of
and negotiation of
Authorization CGEN
contracts
Answers and
explanations by the
applicants
Documents analyses
and requests of
explanation by CGEN
30 days
Before
Procedural
Phase
Time variable
30 days
Answers and
explanations by the
applicants
Routing Process to the
evaluation board of
CGEN
30 days
Procedural Phase
4 months – time variable
CGEN’s Meeting
Authorization
Granted
Development of the activities in
the research project
Deposit of sub-sample of the
products
Notification Annual
Renewal of authorization
30 days
After Procedural Phase
2 years
CGEN
Numbers of Authorizations - CGEN
2001 - 2015
140
122
120
100
Autorizações Totais
88
80
40
33
20
0
Autorizações de empresas
60
60
12
0
4
13
1
2
Source: 2016 – GSS (www.gssconsult.com)
19
0
18
7
30
14
0
7
1
9
1
11
5
35
27
42
CGEN
Federal Law Nº 13.123/2015 - New Legal Framework concerning Brazilian
Biodiversity​
Decree Nº 8.772/2016 - Regulamentation of the new Legal Framework
concerning Brazilian Biodiversity​
CGEN
MP 2186/2001
Prior authorization from CGEN
Law 13123/15
Research Register
Scientific research , technological development and
Bioprospecting
Scientific research , technological development
You can only start your research after the authorization
You notify the research and start.
Receives a research permit issued by CGEN
After registering receives a Certificate of Regularity
All links in the chain need to ask for prior authorization
and pay the benefit sharing
Only the manufacturer of the finished product pays the sharing
of benefits
The value of sharing benefit was negotiated between
the parties ( average 0.25 % / 0.5 % of revenues)
The value of the sharing benefits is set by law: 1% of net income
or 0.75% Project
The payment of the sharing benefits was directly with
the sample provider
Payment of 1 % should be made to the national fund or 0.75 %
for projects
Thiago Augusto Terada
[email protected]