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Decision 391
Common Regime on Access to Genetic Resources
THE COMMISSION OF THE
CARTAGENA AGREEMENT,
HAVING SEEN: The Third
Temporary Provision of Commission Decision 345
and Board Proposal 284/Rev. 1;
WHEREAS:
The Member Countries have
sovereignty over the use and development of
their resources, a principle that has also
been ratified by the Agreement on Biological
Diversity, signed in Rio de Janeiro in June
1992 and legalized by the five Member
Countries;
The Member Countries
possess a sizeable biological and genetic
heritage that should be preserved and
developed on a sustainable basis;
The Andean countries are
characterized by their multi-ethnic and
pluricultural nature;
The biological diversity,
the genetic resources, their endemism and
rarity, as well as the know-how, innovations
and practices of the native, Afro-American and
local communities associated with them, have a
strategic value in the international context;
It is necessary to
recognize the historic contribution made by
the native, Afro-American, and local
communities to the biological diversity, its
conservation and development and the sustained
use of its components, as well as to the
benefits generated by that contribution;
A close interdependence
exists between the native, Afro-American and
local communities and the biological resources
that should be reinforced, in keeping with the
conservation of the biological diversity and
the economic and social development of those
communities and of the Member Countries;
It is necessary to
strengthen integration and scientific,
technical and cultural cooperation, while
moving ahead with the harmonious and
comprehensive development of the Member
Countries;
Genetic resources have an
enormous economic value as a primary source of
products and processes for industry;
DECIDES:
To approve the following:
COMMON REGIME ON ACCESS TO
GENETIC RESOURCES
TITLE I
ON THE DEFINITIONS
Article 1.-
The following definitions shall apply for
purposes of this Decision:
ACCESS: the obtaining
and use of genetic resources conserved in situ
and ex situ, of their by-products and, if
applicable, of their intangible components,
for purposes of research, biological
prospecting, conservation, industrial
application and commercial use, among other
things.
ACCESS CONTRACT:
agreement between the Competent National
Authority in representation of the State, and
a person that establishes the terms and
conditions for access to genetic resources,
their by-products and, if applicable, the
associated intangible component.
ACCESS RESOLUTION:
an administrative order issued by the
Competent National Authority that executes the
access to genetic resources or their by-products,
after having fulfilled all requirements or
conditions stipulated in the access procedure.
BIOLOGICAL DIVERSITY:
the variability of living organisms of any
source whatsoever, including, among others,
land and ocean ecosystems and other aquatic
ecosystems, as well as the ecological
complexes of which they are a part. Covers the
diversity that exists within each species and
between species and within ecosystems as a
result of natural and cultural processes.
BIOLOGICAL RESOURCES:
individuals, organisms or parts of them,
populations or any biotic component of value
or of real or potential use that contains a
genetic resource or its by-products.
BIOTECHNOLOGY: any
technological application that utilizes
biological systems or live organisms, parts of
them or their by-products, to create or modify
products or processes for specific uses.
BY-PRODUCT: a
molecule, a combination or mixture of natural
molecules, including crude extracts of live or
dead organisms of biological origin that come
from the metabolism of living beings.
COMPETENT NATIONAL
AUTHORITY: State entity or public
institution appointed by each Member Country,
authorized to supply the genetic resource or
its by-products and therefore to sign or
supervise the access contracts, to take the
actions provided for in this common regime and
to ensure their performance.
COUNTRY OF ORIGIN OF THE
GENETIC RESOURCE: country that possesses
genetic resources in in situ conditions,
including those which, having been in in situ
conditions, are now in ex situ conditions.
ECOSYSTEM: a
dynamic complex of communities of human beings,
plants, animals and micro-organisms and their
non-living medium that interact as a
functional unit.
EX SITU CONDITIONS:
those in which the genetic resources are not
found in in situ conditions.
EX SITU CONSERVATION
CENTER: a person or institution recognized
by the Competent National Authority that
conserves and collects genetic resources or
their by-products outside their in situ
conditions.
GENETIC DIVERSITY:
variation of genes and genotypes between and
within species. Sum total of the genetic
information contained in biological organisms.
GENETIC EROSION: the
loss of or decrease in genetic diversity.
GENETIC RESOURCES:
all biological material that contains genetic
information of value or of real or potential
use.
IN SITU CONDITIONS:
those in which the genetic resources are found
in their ecosystems and natural environments;
in the case of domesticated or cultivated
species or those having escaped domestication,
in the environments where they developed their
specific properties.
INTANGIBLE COMPONENT:
all know-how, innovation or individual or
collective practice, with a real or potential
value, that is associated with the genetic
resource, its by-products or the biological
resource that contains them, whether or not
protected by intellectual property regimes.
NATIONAL SUPPORT
INSTITUTION: national institution devoted
to biological research of a scientific or
technical nature, that accompanies the
applicant and participates jointly with it in
the access activities.
NATIVE, AFRO-AMERICAN OR
LOCAL COMMUNITY: a human group whose
social, cultural and economic conditions
distinguish it from other sectors of the
national community, that is governed totally
or partially by its own customs or traditions
or by special legislation and that,
irrespective of its legal status, conserves
its own social, economic, cultural and
political institutions or a part of them.
PROGRAM FOR THE
LIBERALIZATION OF GOODS AND SERVICES: a
program whose purpose is to eliminate levies
and restrictions of all kinds on the
importation of goods originating in the
territory of any Member Country, pursuant to
the provisions of the pertinent chapter of the
Cartagena Agreement and all other applicable
rules and regulations of its body of law.
SUPPLIER OF THE
BIOLOGICAL RESOURCE: a person
empowered by this Decision and complementary
national legislation to supply the biological
resource that contains the genetic resource or
its by-products.
SUPPLIER OF THE
INTANGIBLE COMPONENT: a person that,
through an access contract and pursuant to
this Decision and to complementary national
legislation, is empowered to supply the
intangible component associated with the
genetic resource or its by-products.
SUSTAINABLE USE: use
of the components of biological diversity in a
way and at a rate that does not cause their
reduction in the long term and that enables
them to maintain their possibilities for
satisfying the needs and the aspirations of
existing and future generations.
SYNTHESIZED PRODUCT:
a substance obtained through the artificial
processing of genetic information or of
information from other biological molecules.
Includes semi-processed extracts and
substances obtained by converting a by-product
through an artificial process (hemisynthesis).
TITLE II
ON THE PURPOSE AND AIMS
Article 2.-
The purpose of this Decision is to regulate
access to the genetic resources of the Member
Countries and their by-products, in order to:
a) Establish the
conditions for just and equitable
participation in the benefits of the
access;
b) Lay the foundations
for the recognition and valuation of the
genetic resources and their by-products
and of their associated intangible
components, especially when native, Afro-American
or local communities are involved;
c) Promote conservation
of the biological diversity and the
sustainable use of the biological
resources that contain genetic resources;
d) Promote the
consolidation and development of
scientific, technological and technical
capacities at the local, national and
subregional levels; and
e) Strengthen the
negotiating capacity of the Member
Countries.
TITLE III
ON THE SCOPE
Article 3.-
This Decision is applicable to genetic
resources for which is the Member Countries
are the countries of origin, to their by-products,
to their intangible components and to the
genetic resources of the migratory species
that for natural reasons are found in the
territories of the Member Countries.
Article 4.-
The following are excluded from the scope of
this Decision:
a) Human genetic resources
and their by-products; and
b) The exchange of
genetic resources, their by-products, the
biological resources containing them, or
their associated intangible components
among native, Afro-American and local
communities of the Member Countries for
their own consumption, based on their
customary practices.
TITLE IV
ON THE PRINCIPLES
CHAPTER I
ON THE SOVEREIGNY OVER
GENETIC RESOURCES AND
THEIR BY-PRODUCTS
Article 5.-
The Member Countries exercise sovereignty over
their genetic resources and their by-products
and consequently determine the conditions for
access to them, pursuant to the provisions of
this Decision.
The conservation and
sustainable use of the genetic resources and
their by-products are regulated by each Member
Country in keeping with the principles and
provisions of the Biological Diversity
Agreement and of this Decision.
Article 6.-
The genetic resources and their by-products
which originated in the Member Countries are
goods belonging to or the heritage of the
Nation or of the State in each Member Country,
as stipulated in their respective national
legislation.
Those resources are
inalienable, not subject to prescription and
not subject to seizure or similar measures,
without detriment to the property regimes
applicable to the biological resources that
contain those genetic resources, the land on
which they are located or the associated
intangible component.
CHAPTER II
ON THE RECOGNITION OF KNOW-HOW,
INNOVATIONS AND TRADITIONAL
PRACTICES
Article 7.-
The Member Countries, in keeping with this
Decision and their complementary national
legislation, recognize and value the rights
and the authority of the native, Afro-American
and local communities to decide about their
know-how, innovations and traditional
practices associated with genetic resources
and their by-products.
CHAPTER III
ON TRAINING, RESEARCH,
DEVELOPMENT AND
THE TRANSFER OF TECHNOLOGY
Article 8.-
The Member Countries favor the establishment
of scientific and technical training programs,
as well as the execution of research projects
that promote the identification, registration,
characterization, conservation and sustainable
use of the biological diversity and of the by-products
of genetic resources that help to satisfy
local and Subregional needs.
Article 9.-
The Member Countries, recognizing that
technology, including biotechnology, and both
the access to it and its transfer are
essential to the attainment of the objectives
of this Decision, shall ensure and facilitate,
through the corresponding contracts, the
access to technologies that utilize genetic
resources and their by-products, that are
appropriate for the conservation and
sustainable use of the biological diversity
and that do not cause damage to the
environment.
CHAPTER IV
ON SUBREGIONAL COOPERATION
Article 10.-
The Member Countries shall define mechanisms
for cooperation on matters of common interest
concerning the conservation and sustainable
use of genetic resources and their by-products
and the associated intangible components.
They shall also establish
Subregional technical and scientific training
programs on the information, follow-up,
control and evaluation of activities connected
with those genetic resources and their by-products
and for the performance of joint research.
CHAPTER V
ON NATIONAL TREATMENT AND
RECIPROCITY
Article 11.-
The Member Countries grant each other national,
and not discriminatory, treatment in matters
relating to access to genetic resources.
Article 12.-
The Member Countries may grant national and
non-discriminatory treatment to third
countries that give them equal treatment.
CHAPTER VI
ON PRECAUTION
Article 13.-
The Member Countries may adopt measures aimed
to impeding genetic erosion or the degradation
of the environment and of the natural
resources. If the danger of serious and
irreversible damage exists, the lack of
scientific certainty should not be seized upon
as a reason for postponing the adoption of
effective measures.
The principle of precaution
should be applied in keeping with the
provisions in the Chapter on the
Liberalization Program of the Cartagena
Agreement and the other applicable rules and
regulations of the body of law of this
Agreement.
CHAPTER VII
ON FREE SUBREGIONAL TRAFFIC
IN BIOLOGICAL RESOURCES
Article 14.-
Provided that there is no access to the
genetic resources contained in the biological
resources referred to in this Decision, the
provisions of this regime shall not hinder the
use of and free movement of in those
biological resources, nor the fulfillment of
the provisions of the CITES Convention on
health, food security, biosecurity and the
obligations stemming from the Program of
Liberalization of goods and services among
Member Countries.
CHAPTER VIII
ON THE JURIDICAL SECURITY
AND TRANSPARENCY
Article 15.-
Provisions, procedures and acts of government
authorities of the Member Countries with
regard to access, shall be clear, effective,
well-grounded and lawful.
The actions performed and
information provided by individuals shall
likewise be lawful, complete and truthful.
TITLE V
ON THE ACCESS PROCEDURE
CHAPTER I
ON THE GENERAL ASPECTS
Article 16.-
All access procedures shall require the
presentation, admittance, publication and
approval of an application, the signing of a
contract, the issuing and publication of the
corresponding Resolution and the declarative
registration of the acts connected with that
access.
Article 17.-
The applications for access and access
contracts and, if appropriate, accessory
contracts shall include conditions like the
following:
a) The participation of
Subregional nationals in the research on
genetic resources and their by-products
and on the associated intangible component;
b) Support for research
within the jurisdiction of the Member
Country of origin of the genetic resource
or in any other Subregional Member Country
that contributes to the conservation and
sustainable use of the biological
diversity;
c) The strengthening of
mechanisms for the transfer of know-how
and technology, including biotechnology,
that is culturally, socially and
environmentally healthy and safe;
d) The supply of
information about the background and
status of the science and about other
matters that would contribute to a better
knowledge of the situation regarding the
genetic resource that originated in the
Member Country, its by-product or
synthesized product and its associated
intangible component;
e) The strengthening
and development of the institutional
capacity of the country or the Subregion
in regard to genetic resources and their
by-products;
f) The strengthening
and development of the capacities of the
native, Afro-American and local
communities with relation to the
associated intangible components, the
genetic resources and their by-products;
g) The compulsory
deposit of duplicates of all material
collected, at institutions designated by
the Competent National Authority;
h) The obligation to
inform the Competent National Authority
about the results of the research carried
out; and
i) The terms for the
transfer of the material to which third
parties are given access.
Article 18.-
The documents connected with the access
procedure shall appear in a public file that
the Competent National Authority shall keep.
That file shall consist of
the following, at least: the application; the
identification of the applicant, the resource
supplier, and the national support person or
institution; the site or area to which the
access applies; the access methodology; the
project proposal; the parts of the access
contract that are not subject to
confidentiality; the opinion about and
registry of visits; and, if applicable, the
evaluation studies of the economic, social and
environmental impact or of the environmental
permits.
Also included in the file
are the Resolution executing the access, the
reports supplied by the national support
person or institution, and the follow-up and
supervisory reports provided by the Competent
National Authority or the entity delegated to
perform that task. That file is open to
consultation by any person.
Article 19.-
The Competent National Authority may give
confidential treatment to data and information
supplied to it in the course of the access
procedure or the contract performance, and not
previously disclosed, which could be put to
unfair commercial use by third parties, unless
the knowledge of this data and information by
the public is necessary to protect the social
interest or the environment.
Accordingly, the applicant
should state the grounds for its petition,
accompanied by a non-confidential summary that
will become a part of the public file.
The information or
documents referred to in the second paragraph
of Article 18 of this Decision cannot be made
confidential.
The confidential aspects
shall be covered in a separate file, in the
custody of the Competent National Authority,
and may not be disclosed to third parties,
unless that is judicially ordered.
Article 20.-
If the petition for confidential treatment
fails to comply with the requirements
established in the previous article, the
Competent National Authority shall deny it as
a matter of right.
Article 21.-
The Competent National Authority shall keep a
public registry where the following
information shall be entered, among other
data: the Resolution that may possibly deny
the petition, the access contract signing,
amendment, suspension and termination dates,
the date and number of the Resolution
executing or canceling it, the date and number
of the Resolution, award or sentence
determining the nullity or imposing penalties,
with an indication of their kind and the
parties, and accessory contract signing,
amendment, suspension, termination and
nullification dates.
That registry shall be of a
declaratory nature.
Article 22.-
As stipulated in Article 15, the execution of
the access is dependent upon the provision of
full and reliable information by the applicant,
as called for by law.
In this connection, the
applicant should present the Competent
National Authority with all of the information
about the genetic resource and its by-products
that it knows or is in a position to know at
the moment the application is presented. That
information shall include the present and
potential uses of the resource, by-product or
intangible component, their sustainability and
the risks that could result from the access.
The statements made by the
applicant in the application and in the
contract, including their respective annexes,
shall be in the nature of a sworn statement.
Article 23.-
The permits, authorizations and other
documents that support the investigation,
obtaining, provision, transfer, etc., of
biological resources, shall not determine,
qualify or presume the authorization of the
access.
Article 24.-
It is forbidden to use genetic resources and
their by-products in biological weapons or for
practices that are harmful to the environment
or to human health.
Article 25.-
The transfer of technology shall be carried
out in accordance with the provisions
contained in the body of law of the Cartagena
Agreement, complementary national provisions
and such rules and regulations on biosecurity
and the environment as the Member Countries
may approve.
Article 26.-
The access to and transfer of technology
subject to patents or other intellectual
property rights, shall be accomplished in
keeping with the Subregional and complementary
national provisions regulating that area.
CHAPTER II
ON THE APPLICATION FOR
ACCESS
Article 26.-
The procedure starts with the presentation to
the Competent National Authority of an
application for access which should contain:
a) Identification of
the applicant and, if pertinent, documents
that accredit its legal capacity to make a
contract;
b) Identification of
the supplier of the genetic and biological
resources and their by-products or of the
associated intangible component;
c) Identification of
the national support person or institution;
d) Identification and
curriculum vitae of the person responsible
for the project and of his working group;
e) The access activity
applied for; and
f) The location or area
where the access is to be carried out,
with an indication of its geographical
coordinates.
The application shall be
accompanied by the project proposal,
considering the referential model the Board
approves through a Resolution.
Article 27.-
If the application with its accompanying
project proposal is complete, the Competent
National Authority shall accept it, assign it
a presentation or filing date, record it in
the report and enter it with a declarative
intent in the public registry it shall keep
for that purpose and open the corresponding
file.
Were the application to be
incomplete, the Competent National Authority
would return it without delay, indicating the
information that is missing, so that it might
be completed.
Article 28.-
Within five working days following the date of
entry of the application in the public
registry referred to in the previous article,
an extract of that application shall be
published in a newspaper with broad national
circulation and in another medium of the place
where the access is to be effected, so that
those that wish to might supply information to
the Competent National Authority.
Article 29.-
Within thirty working days after its
registration, the Competent National Authority
shall evaluate the application, make the
visits it deems necessary and issue a
technical and legal opinion about its
propriety or invalidity. That period may be
extended to up to sixty working days if the
Competent National Authority considers it
desirable.
Article 30.-
When the time limit stipulated in the previous
article expires, or before that, if
appropriate, the Competent National Authority
shall accept or deny the application, based on
the results of the opinion, the records of
visits, the information supplied by third
parties, and the fulfillment of the conditions
established in this Decision.
The applicant shall be
advised about the acceptance of the
application and project proposal within five
working days after this occurs. The access
contract shall then be immediately drawn up
and negotiated.
In the event that the
application and project proposal are denied,
this shall be communicated through a justified
Resolution and the matter shall be considered
finished. This does not, however, preclude the
filing of such objections as are in order,
according to the procedures established in the
national legislation of Member Countries.
Article 31.-
If required by the national law of the Member
Country or if the Competent National Authority
deems it necessary, the applicant shall comply
with environmental provisions in effect.
The procedures that should
be followed in that event shall be independent
from those stipulated in this Decision and may
be started beforehand. Nonetheless, they must
be concluded before the expiration of the time
limit stipulated in Article 29 and must be
considered by the Competent National Authority
in making its evaluation.
Were the Competent National
Authority to require such studies, it could
grant the applicant a supplementary period set
exclusively in accordance with the time needed
to complete and submit them for its
consideration.
CHAPTER III
ON THE ACCESS CONTRACT
Article 32.-
The parties to the access contract are:
a) The State,
represented by the Competent National
Authority; and
b) The applicant requesting
the access.
The applicant must be
legally empowered to make a contract in the
Member Country in which it requests the access.
Article 33.-
The terms of the access contract must be in
keeping with the provisions of this Decision
and Member Country national legislation.
Article 34.-
The access contract shall bear in mind the
rights and interests of the suppliers of
genetic resources and their by-products, the
biological resources that contain them and the
intangible component as applicable, in
accordance with the corresponding contracts.
Article 35.-
When access is requested to genetic resources
or their by-products with an intangible
component, the access contract shall
incorporate, as an integral part of that
contract, an annex stipulating the fair and
equitable distribution of the profits from use
of that component.
The annex shall be signed
by the supplier of the intangible component
and the applicant for the access. It may also
be signed by the Competent National Authority,
in accordance with the provisions of national
law of the Member Country. If that annex is
not signed by the Competent National Authority,
it shall be subject to the suspensive
condition referred to in Article 42 of this
Decision.
Failure to comply with the
stipulations of the annex shall constitute
grounds for the rescission and nullification
of the access contract.
Article 36.-
The Competent National Authority may enter
into access contracts with universities,
research centers or well-known researchers to
support the execution of several projects, as
provided for in this Decision and in keeping
with the national legislation of each Member
Country.
Article 37.-
The ex-situ conservation centers or other
institutions that perform activities involving
access to genetic resources or their by-products
and, if appropriate, the associated intangible
component, should enter into access contracts
with the Competent National Authority,
pursuant to this Decision.
That Authority may likewise
sign access contracts with third parties in
regard to genetic resources of which the
Member Country is the country of origin and
which have been deposited at those centers,
bearing in mind the rights and interests
referred to in Article 34.
CHAPTER IV
ON THE EXECUTION OF THE
ACCESS
Article 38.-
Once the contract has been adopted and signed,
the corresponding Resolution shall be issued
in a joint act. This resolution shall then be
published together with an extract of the
contract, in the Official Newspaper or a
newspaper with wide national circulation. As
of that moment, the access shall be considered
to have been granted.
Article 39.-
Such contracts as are signed in violation of
the provisions of this regime shall be null
and void. The nullification procedure shall be
subject to the national provisions of the
Member Country in which it is invoked.
Article 40.-
The rescission or resolution of the contract
shall be motive for the official cancellation
of the registration by the Competent National
Authority.
TITLE VI
ON THE ANCILLARY CONTRACTS
TO THE ACCESS CONTRACT
Article 41.-
Ancillary contracts are those that are signed
in order to carry out activities connected
with the genetic resource or its by-products,
between the applicant and:
a) The owner, possessor
or manager of the land where the
biological resource containing the genetic
resource is located;
b) The ex situ
conservation center;
c) The owner, possessor
or manager of the biological resource
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