Common Regime on Access to Genetic
THE COMMISSION OF THE CARTAGENA AGREEMENT,
The Third Temporary Provision of Commission
345 and Board Proposal 284/Rev. 1;
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
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
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;
To approve the following:
COMMON REGIME ON ACCESS TO GENETIC RESOURCES
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
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.
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
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.
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.
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
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.
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
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.
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).
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
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.
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
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
ON THE PRINCIPLES
ON THE SOVEREIGNTY OVER GENETIC RESOURCES AND THEIR
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
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
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
ON THE RECOGNITION OF KNOW-HOW, INNOVATIONS AND
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.
ON TRAINING, RESEARCH, DEVELOPMENT AND THE TRANSFER OF
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.
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.
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
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.
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.
ON JURIDICAL SECURITY AND TRANPARENCY
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.
ON THE ACCESS PROCEDURE
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
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
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
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
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
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
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
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
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
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.
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
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
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.
ON THE ACCESS CONTRACT
Article 32.- The parties to the access contract
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
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
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
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.
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
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.
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
containing the genetic resource; or
d) The national support institution, with regard to activities that
it should perform and that are not a part of the access contract.
Making an ancillary contract does not authorize access to the genetic
resource or its by-product, and its contents are subject to the
stipulations of the access contract as provided for in this Decision.
The national support institution must be accepted by the Competent
Article 42.- Such ancillary contracts as are signed shall
include a condition that subjects their execution to that of the access
As of that moment, they shall become effective and binding and shall be
governed by the mutually agreed terms, the provisions of this Decision and
applicable Subregional and national legislation. The responsibility for
their execution and compliance lies only with the parties to the contract.
Article 43.- Without detriment to what has been agreed upon
in the accessory contract and independently of it, the national support
institution shall be obliged to collaborate with the Competent National
Authority in the follow-up and supervision of the genetic resources,
by-products or synthesized products and associated intangible components,
and to submit reports about the activities for which it is responsible, in
the way or with the frequency that the Authority stipulates, according to
the access activity.
Article 44.- The nullity of the access contract produces
the nullity of the ancillary contract.
The Competent National Authority may also terminate the access contract
when the nullity of the ancillary contract is declared, if the latter is
essential for the access.
Its amendment, suspension, rescission or resolution may likewise
produce the amendment, suspension, rescission or resolution of the access
contract by the Competent National Authority if it substantially affects
the conditions of the latter contract.
ON THE LIMITATIONS TO ACCESS
Article 45.- Member Countries may establish,
through an express legal rule, partial or total limitations on access to
genetic resources or their by-products in the following cases:
a) Endemism, rarity or danger of extinction of species, subspecies,
varieties or races or breeds;
b) Vulnerability or fragility of the structure or functioning of
the ecosystems that could worsen as a result of access activities;
c) Adverse effects of access activities on human health or on
elements essential to the cultural identity of nations;
d) Undesirable or not easily controlled environmental effects of
access activities on the ecosystems;
e) Danger of genetic erosion caused by access activities;
f) Regulations on biosecurity; or
g) Genetic resources or geographic areas rated as strategic.
ON VIOLATIONS AND SANCTIONS
Article 46.- Any person performing access
activities without the respective authorization shall be liable for
Also to be sanctioned is any person carrying out transactions with
regard to by-products or synthesized products of such genetic resources or
the associated intangible component, that is not protected by the
corresponding contracts, signed in keeping with the provisions of this
Article 47.- The Competent National Authority, pursuant to
the procedure provided for in its own national legislation, may apply
administrative sanctions, such as fines, preventive or definitive
confiscation, temporary or definitive closing-down of establishments and
disqualification of the violator from applying for new accesses in cases
of violation of this regime.
Those sanctions shall be applied without detriment to the suspension,
cancellation of nullification of the access, the payment of compensation
for such damages and losses as are incurred, including those caused to the
biological diversity, and the civil and criminal sanctions that may
possibly be in order.
ON THE NOTIFICATIONS BETWEEN MEMBER COUNTRIES
Article 48.- The Member Countries shall
notify each other immediately through the Board, of all applications for
access and access resolutions and authorizations, as well as of the
suspension and termination of such contracts as are signed.
They shall also advise each other about the signing of any bilateral or
multilateral agreement on the subject, which must be in keeping with the
provisions of this Decision.
Article 49.- Without prejudice to the stipulations of the
previous article, the Member Countries shall immediately inform each other
through the Board of all provisions, decisions, regulations, judgments,
resolutions and other rules and acts adopted nationally that have to do
with the provisions of this Decision.
ON THE COMPETENT NATIONAL AUTHORITY
Article 50.- The Competent National Authority
shall perform all of the functions conferred on it in this Decision and in
Member Country national legislation. In this connection, it shall be
a) Issue the necessary internal administrative provisions to comply
with this Decision and, until the appropriate Community rules and
regulations are enacted, stipulate how the genetic resources and their
by-products shall be identified and packed;
b) Receive, evaluate, accept or deny applications for access;
c) Negotiate, sign and authorize access contracts and issue the
corresponding access resolutions;
d) Ensure the rights of suppliers of biological resources that
contain genetic resources and of the intangible component;
e) Keep the technical files and the Public Registry of Access to
Genetic Resources and their by-products;
f) Keep a directory of persons or institutions pre-qualified to
perform scientific or cultural support tasks;
g) Amend, suspend, nullify or terminate access contracts and
arrange their cancellation, as the case may be, in keeping with the
terms of those contracts, this Decision and Member Country
h) Oppose the suitability of the national support institution
proposed by the applicant and demand its replacement by another,
i) Supervise and control compliance with the contractual conditions
and the provisions of this Decision and accordingly establish such
monitoring and evaluation mechanisms as it deems advisable;
j) Review, in keeping with this Decision, contracts involving
access already signed with other institutions or persons and carry out
the corresponding actions for repossession;
k) Delegate supervisory activities to other institutions, while
keeping the responsibility and direction over that supervision, in
conformity with national legislation;
l) Supervise the state of conservation of the biological resources
containing the genetic resources;
m) Coordinate continuously with its respective liaison institutions
all matters having to do with fulfillment of the provisions of this
n) Keep the national inventory of genetic resources and their
o) Keep in continuous contact with the competent national offices
for industrial property and set up appropriate information systems
with them; and
p) All such other functions as the domestic legislation of the
Member Country itself may assign it.
ON THE ANDEAN COMMITTEE ON GENETIC RESOURCES
Article 51.- The Andean Committee on Genetic
Resources is hereby created, such to be comprised of the Directors of
the Competent National Authorities on matters of Access to Genetic
Resources or their representatives, their advisors and such
representatives of other interested sectors as each Member Country may
The Committee shall be responsible for:
a) Issuing national and Subregional recommendations for the best
possible fulfillment of this Decision;
b) Issuing technical recommendations on such matters as the Member
Countries may submit for its consideration;
c) Recommending the mechanisms for establishing an Andean
information network on applications for access and access contracts in
d) Recommending and promoting joint actions to strengthen Member
Country capacity in research, management and transfer of technology
connected with genetic resources and their by-products;
e) Recommending to the Board for adoption through Resolutions,
common documentation models, particularly those that will make it
possible to easily verify the coding and identification of genetic
resources and their by-products, as well as the legality of the
f) Promoting management, surveillance, control and supervision of
access authorizations relating to genetic resources and their
by-products that exist in two or more Member Countries;
g) Recommending and promoting joint emergency plans and warning
mechanisms to prevent or resolve problems relating to access to
genetic resources or their by-products;
h) Taking cooperative actions with regard to genetic resources or
i) Drawing up their own internal regulations;
j) Writing an explanatory manual of this Decision; and
k) Such other functions as the Member Countries may assign to them.
FIRST.- The Member Countries shall, in keeping with their
national legislation, set up or reinforce funds or other types of
financial mechanisms financed by the profits from the access and
resources from other sources to promote compliance with the aims of this
Decision, under the direction of the Competent National Authority.
Through the Andean Committee on Genetic Resources, the Member Countries
shall design and implement joint programs for the conservation of genetic
resources and shall study the viability and desirability of creating an
Andean Fund for their conservation.
SECOND.- The Member Countries shall not acknowledge rights,
including intellectual property rights, over genetic resources,
by-products or synthesized products and associated intangible components,
that were obtained or developed through an access activity that does not
comply with the provisions of this Decision.
Furthermore, the Member Country affected may request nullification and
bring such actions as are appropriate in countries that have conferred
rights or granted protective title documents.
THIRD.- The Competent National Offices on Intellectual Property
shall require the applicant to give the registration number of the access
contract and supply a copy of it as a prerequisite for granting the
respective right, when they are certain or there are reasonable
indications that the products or processes whose protection is being
requested have been obtained or developed on the basis of genetic
resources or their by-products which originated in one of the Member
The Competent National Authority and the Competent National Offices on
Intellectual Property shall set up systems for exchanging information
about the authorized access contracts and intellectual property rights
FOURTH.- Such health certificates supporting the export of
biological resources as are issued in accordance with Commission
328, its amendments or addenda, shall incorporate the following statement
at the end of the format: "Use of this product as a genetic resource
is not authorized."
The Competent National Authority may enter into, with
the institutions referred to in Article 36, contracts for the deposit of
genetic resources or their by-products or of the biological resources
containing them, exclusively for purposes of their care, keeping those
resources under its jurisdiction and control.
Likewise, it may make contracts that do not involve access, such as
intermediation or administration contracts, in relation to genetic
resources or their by-products or synthesized products, in keeping with
the provisions of this Regime.
SIXTH.- When requesting access to genetic resources from
protected areas or their by-products, the applicant must fulfill, in
addition to the stipulations of this Decision, also the special national
legislation on the subject.
FIRST.- Any disputes that may arise among Member Countries shall be
settled as stipulated in the Andean body of law.
Any disputes that arise with third countries must be settled according
to the provisions of this Decision. If a dispute arises with a third
country party to the Agreement on Biological Diversity, signed in Rio de
Janeiro on June 5, 1992, the solution adopted must also abide by the
principles established in that Agreement.
SECOND.- In negotiating the terms of access contracts to genetic
resources that originated in more than one Member Country or to their
by-products and in carrying out activities connected with that access, the
Competent National Authority shall bear in mind the interests of the other
Member Countries, which may present their viewpoints and such information
as they deem advisable.
THIRD.- The Board, through a Resolution and after hearing the
opinion of the Andean Committee on Genetic Resources, may execute or
adjust the procedure stipulated in Title V, Chapters I and II of this
This Decision shall become effective on the date of its
publication in the Official Newspaper of the Cartagena Agreement.
FIRST.- On the date this Decision enters into force, those which
possess, for purposes of access, genetic resources originated in the
Member Countries, their by-products or associated intangible components,
shall negotiate that access with the Competent National Authority pursuant
to the provisions of this Decision. Accordingly, the Competent National
Authorities shall set the time limits, which cannot exceed twenty-four
months as of the date this Decision becomes effective.
Until this requirement is fulfilled, the Member Countries may
disqualify such persons, as well as the institutions they represent or on
whose account they act, from applying for new accesses to genetic
resources or their by-products in the Subregion. This does not preclude
the application of such sanctions as are in order once the time limit
referred to in the previous paragraph expires.
Contracts or agreements signed by Member Countries or
their public or State institutions with third parties in regard to genetic
resources, their by-products, the biological resources containing them or
associated intangible components, that are not in conformity with this
Decision, may be renegotiated or may fail to be renewed, as applicable.
The renegotiation of such contracts or agreements, as well as the
signing of new ones, shall be accomplished by common agreement among the
Member Countries. To this end, the Andean Committee on Genetic Resources
shall establish the common criteria.
THIRD.- The Member Countries may take such legal action as they
deem advisable for the repossession of genetic resources of which they are
the countries of origin, their by-products and the associated intangible
components and for the collection of any damages and compensation to which
they are entitled.
Only the State has the legal entitlement to the action for repossession
of those genetic resources and their by-products.
FOURTH.- The Board, through a Resolution and after hearing the
opinion of the Andean Committee on Genetic Resources, shall establish the
necessary systems for the identification and packing of the genetic
resources and, if applicable, their by-products.
FIFTH.- Within a period of no more than 30 working days after
this Decision enters into force, the Member Countries shall designate the
Competent National Authority on access to genetic resources and shall
accredit it before the Board.
SIXTH.- The Member Countries, within a period of no more than 30
working days after this Decision enters into force, shall accredit before
the Board their representatives to the Andean Committee on Genetic
SEVENTH.- The Member Countries shall adopt a common regime on
biosecurity within the framework of the Agreement on Diversity. To that
end, the Member Countries, in coordination with the Board, shall start the
respective studies, particularly with regard to the cross-border movement
of modified live organisms produced by biotechnology.
The Board shall draw up, within a period of three
months after the Member Countries present their national studies, a
proposal to establish a special regime or a harmonization regulation, as
applicable, aimed at reinforcing the protection of know-how, innovations
and traditional practices of native, Afro-American and local communities,
in keeping with the provision of Article 7 of this Decision, ILO
Convention 169 and the Agreement on Biological Diversity.
To that end, the Member Countries should present their respective
national studies during the year after this Decision enters into effect.
NINTH.- The Member Countries shall design a training program to
strength the capacity of the native, Afro-American and local communities
to negotiate the intangible component within the context of access to
The Board, through a Resolution, shall adopt the
reference models for the application for access to genetic resources and
the access contract, within a period of no more than fifteen days after
this Decision comes into effect.
Signed in the city of Caracas, Venezuela on the second of July of