Andean Pact

Andean Pact English

Andean Pact

(Private Translation from Spanish)

Decision 391

Common System on Access to Genetic Resources

THE COMMISSION OF THE CARTAGENA AGREEMENT,

Referring to:

The Third Interim Measure of Decision 345 of the Commission and Proposal 284 of the Board;

Whereas:

The Member Countries have sovereign rights over the use and exploitation of their resources, a principle which has furthermore been ratified by the Convention on Biological Diversity, signed in Rio de Janeiro in June 1992 and endorsed by the five Member States;

The Member Countries have an important biological and genetic heritage which must be preserved and used in a sustainable manner;

The Andean countries are by nature multi-ethnic and pluricultural;

Biological diversity, genetic resources, endemism and rarity, as well as the knowledge, innovations and practices of indigenous, Afro-American and local communities in relation to these, are of strategic value at international level;

It is necessary to recognise the historical contribution of indigenous, Afro-American and local communities to biological diversity, its conservation, development and the sustainable use of its components, as well as the benefits yielded by such contribution;

That indigenous, Afro-American and local communities maintain a close interdependence with biological resources which must be strengthened in order to conserve biological diversity and promote the economic and social development of these communities and of the Member Countries;

It is necessary to strengthen scientific, technical and cultural cooperation and integration, as well as the integral, harmonious development of the Member Countries;

Genetic resources are of great economic value, since they are a primary source of products and processes for industry;

Hereby decides:

To approve the following:

COMMON SYSTEM ON ACCESS TO GENETIC RESOURCES

Title I: USE OF TERMS

Article 1

For the purposes of this decision:

"Access" means the acquisition and use of genetic resources conserved in ex-situ and in-situ conditions and of their derivatives or, as applicable, intangible components, for purposes of research, biological prospecting, conservation, industrial application or commercial use, among others.

"Competent National Authority" means the public state authority or body designated by each Member Country and authorized to provide the genetic resource or its derivatives and, consequently, to sign or inspect access contracts, carry out the actions envisaged in this common system and ensure compliance with them.

"Biotechnology" means any technological application that uses biological systems, living organisms or parts or derivatives thereof, to create or modify products or processes for specific uses.

"Ex-situ conservation centre" means a party recognized by the Competent National Authority, engaged in conserving and collecting genetic resources or their derivatives outside their in-situ conditions.

"Intangible component" means any knowledge, innovation or individual or collective practice of actual or potential value associated with the genetic resource, its derivatives or the biological resource containing them, whether or not it is protected by intellectual property systems.

"Indigenous, Afro-American or local community" means a human group whose social, cultural and economic conditions distinguish it from other sectors of the national population and which is wholly or partially governed by its own customs or traditions or by special legislation and which, regardless of its legal status, retains, wholly or in part, its own social, economic, cultural and political institutions.

"In-situ conditions" means conditions where genetic resources exist within their natural habitats and ecosystems and, in the case of domesticated, cultivated or escaped species, in the surroundings where they have developed their distinctive properties.

"Ex-situ conditions" means conditions where genetic resources exist outside in-situ conditions.

"Access contract" means an agreement between the Competent National Authority, representing the state, and a person, establishing the terms and conditions for access to genetic resources, their derivatives and, as applicable, related intangible components.

"Biological diversity" means the variability of living organisms from all sources, including, inter alia, terrestrial and marine and other aquatic ecosystems and the ecological complexes of which they are part. This includes diversity within species, between species and of ecosystems, resulting from natural and cultural processes.

"Genetic diversity" means variety of genes and genotypes between and within species; it is the sum total of genetic information contained in biological organisms.

"Ecosystem" means a dynamic complex of human, plant, animal and micro-organism communities and their non-living environment interacting as a functional unit.

"Genetic erosion" means the loss or reduction of genetic diversity.

"National support institution" means a legally incorporated national entity engaged in biological research of a scientific or technical nature, which accompanies the applicant and participates jointly with him in access activities.

"Country of origin of the genetic resource" means the country which possesses the genetic resources in in-situ conditions, including resources which, having originally been in such conditions, are now found in ex-situ conditions.

"Derivative" means a molecule or combination or mixture of natural molecules, including raw extracts of living or dead organisms of biological origin, derived from the metabolism of living organisms.

"Synthesized product" means a substance obtained by means of an artificial process, using genetic information or other biological molecules. This includes semi-processed extracts and substances obtained through treatment of a derivative using an artificial process (hemisynthesis).

"Programme of liberalization of goods and services" means a programme intended to eliminate levies and restrictions of all types on the import of products originating in the territory of any of the Member Countries, pursuant to the corresponding chapter of the Cartagena Agreement and other applicable standards contained in the legal ordinances of said Agreement.

"Supplier of an intangible component" means a person authorized under the terms of an access contract and within the framework of this decision and under any complementary national legislation to supply the intangible component associated with a genetic resource or its derivatives.

"Biological resources" means individuals, organisms or parts thereof, populations or any biotic component with actual or potential value or use contained by the genetic resource or its derivatives.

"Genetic resources" means any biological material containing genetic information of actual or potential value.

"Resolution of access" means an administrative document issued by the competent national authority, delivering access to genetic resources or their derivatives, once all the terms and conditions established in the access procedure have been complied with.

"Sustainable use" means the use of components of biological diversity in a way and at a rate that does not lead to the long-term decline of biological diversity, thereby maintaining its potential to meet the needs and aspirations of present and future generations.

Title II: OBJECTIVE AND AIMS

Article 2

The objective of the present decision is to regulate access to the genetic resources of the Member Countries and their derivatives, in order to:

(a) Create the conditions for fair and equitable sharing of the benefits accruing from such access;

(b) Establish a basis for the recognition and appreciation of genetic resources, their derivatives and related intangible components, particularly where indigenous, afro-american and local communities are involved;

(c) Encourage the conservation of biological diversity and sustainable use of biological resources containing genetic resources;

(d) Promote the consolidation and development of scientific, technological and technical capacities at local, national and subregional level; and

(e) Strengthen the negotiating capacity of the Member Countries.

Title III: SCOPE

Article 3

The present decision shall apply to genetic resources for which the Member Countries are countries of origin, their derivatives and intangible components and to the genetic resources of migratory species found for natural reasons in the territory of the Member Countries.

Article 4

The following are excluded from the present decision:

(a) Human genetic resources and their derivatives;

(b) The exchange of genetic resources, their derivatives, the biological resources in which they are found, and related intangible components by indigenous, afro-american or local communities of the Member Countries, either among each other or for their own consumption, in accordance with their customary practices.

Title IV: PRINCIPLES

Chapter I

Sovereignty over genetic resources and their derivatives

Article 5

The Member Countries have sovereign rights over their genetic resources and derivatives thereof and therefore determine the conditions of access to said resources, pursuant to the contents of this decision.

The conservation and sustainable use of genetic resources and their derivatives shall be regulated by each Member Country, according to the principles and provisions enshrined in the Convention on Biological Diversity and in the present decision.

Article 6

Any genetic resources and derivatives thereof, for which the Member Countries are countries of origin, are the property or patrimony of the Nation or State of each Member Country, as established by their respective internal legislation.

Such resources are inalienable, imprescriptible and non-distrainable, without prejudice to the systems of ownership applicable to the biological resources containing them, property on which they are located or to any associated intangible component.

Chapter II

Recognition of traditional practices, knowledge

and innovations

Article 7

The Member Countries, in accordance with this decision and their complementary national legislation, recognize and value the rights and decision-making capacity of indigenous, afro-american and local communities with regard to their traditional practices, knowledge and innovations connected with genetic resources and their derivatives.

Chapter III

Training, research, development and transfer of technology

Article 8

The Member Countries support the creation of scientific and technical training programmes, as well as the development of research projects encouraging the identification, registration classification, conservation and sustainable use of biological diversity and of derivatives of genetic resources able to help satisfy local and subregional needs.

Article 9

The Member Countries, recognizing that technology includes biotechnology and that both access to and transfer of technology are essential elements for the attainment of the objectives of this decision, shall safeguard and facilitate, by means of the necessary contracts, access to technologies using genetic resources and their derivatives that are appropriate to the conservation and sustainable use of biological diversity and are not harmful to the environment.

Chapter IV

Subregional cooperation

Article 10

The Member Countries shall define mechanisms for cooperation on matters of mutual interest connected with the conservation and sustainable use of genetic resources and their derivatives and related intangible components.

They shall likewise create subregional technical and scientific training programmes in the fields of information, follow-up, monitoring and evaluation of activities connected with said genetic resources and their derivatives and for the development of joint research initiatives.

Chapter V

National treatment and reciprocity

Article 11

The Member Countries shall grant each other non-discriminatory national treatment in matters relating to access to genetic resources.

Article 12

The Member Countries may grant non-discriminatory national treatment to third countries which grant them the same privilege.

Chapter VI

Precaution

Article 13

The Member Countries may adopt measures to prevent genetic erosion or degradation of the environment and natural resources. Where there is a risk of serious and irreversible damage, lack of scientific certainty should not be used as a reason for postponing the adoption of effective measures.

The principle of precaution should be applied, in accordance with the provisions of the relevant chapter of the Liberalization Programme of the Cartagena Agreement and other applicable standards contained in the legal ordinances of this Agreement.

Chapter VII

Free movement of biological resources in the subregion

Article 14

Provided that access is not made to the genetic resources contained in biological resources referred to in this decision, the provisions of this system shall not impede either the use and free movement of said biological resources, compliance with the provisions of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), or requirements relating to health, food safety, biosafety or obligations arising from the programme of liberalization of goods and services among the Member Countries.

Chapter VIII

Legal safeguards and transparency

Article 15

Any access-related measures, procedures and acts undertaken by the governmental authorities of the Member Countries shall be clear, effective, informed and legally valid.

Similarly, actions by and information provided by individuals should be complete, truthful and legally valid.

Title V: ACCESS PROCEDURE

Chapter I

General aspects

Article 16

All access procedures must include the presentation, admission, publication and approval of an application, signature of a contract, issue and publication of the corresponding resolution and a declaratory record of actions linked with such access.

Article 17

Applications for and contracts of access and, as applicable, any accessory contracts, shall include conditions such as the following:

(a) Participation by nationals of the subregion in research activities into genetic resources, their derivatives and associated intangible components;

(b) Support for research contributing to the conservation and sustainable use of biological diversity being carried out under the jurisdiction of the Member Country which is the country of origin of the genetic resource, or in any other country of the subregion;

(c) Strengthening of mechanisms for the transfer of knowledge and technologies, including biotechnologies, which are culturally, socially and environmentally safe and healthy;

(d) Provision of information on antecedents, scientific progress or of any other nature likely to contribute to greater knowledge of matters relating to the genetic resource for which the Member Country is also the country of origin, its derivative or synthesized product and associated intangible component;

(e) Strengthening and development of national or subregional institutional capacities connected with genetic resources and their derivatives;

(f) Strengthening and development of the capacities of indigenous, afro-american and local communities with regard to the intangible components associated with genetic resources and their derivatives;

(g) Obligatory deposit, in institutions designated by the Competent National Authority, of duplicates of all material collected;

(h) Obligation to inform the Competent National Authority of the results of research carried out;

(i) Terms under which material obtained may be transferred to third parties.

Article 18

The documents relating to the access procedure shall be included in a public record file kept by the Competent National Authority.

The file shall at least include, among other items: the application; identification of the applicant, supplier of the resource and national support institution or individual; the locality or area in which access will be made; the methodology of access; project proposal; those parts of the access contract which have not been ruled confidential; the visit protocol and ruling; and, where applicable, environmental, economic and social impact assessment reports or environmental permit studies.

The file shall also include the resolution delivering access, reports submitted by the national support institution or individual, and follow-up and monitoring reports by the Competent National Authority or body delegated by it. The record shall be open to public scrutiny.

Article 19

The Competent National Authority may give confidential treatment to any information or data which it receives in connection with the access procedure or contract execution which has not been divulged and could be used for disloyal commercial purposes by a third party, except when public knowledge of the same is necessary in order to protect social interests or the environment.

In such cases, the applicant should present a justification of his petition, together with a non-confidential summary for inclusion in the public record.

Confidentiality may not be extended to information or documents referred to under paragraph 2 of Article 18 of this decision.

Confidential aspects shall be kept in a separate file to be held in the keeping of the Competent National Authority and may not be divulged to third parties except following a court order to the contrary.

Article 20

If the petition for confidential treatment fails to comply with the requirements given in the previous article, it will be legally dismissed by the Competent National Authority.

Article 21

The Competent National Authority will keep a public record in which will be entered, among other items: the resolution dismissing the application, if applicable; the dates of signature, modification, suspension and termination of the access contract; the date and number of the resolution delivering or cancelling the contract; the date and number of the resolution, adjudication or order leading to annulment or imposing sanctions, indicating the type, parts and dates of signature, modification, suspension, termination and annulment of the accessory contracts.

The above record shall be of a declaratory nature.

Article 22

As provided under article 15, delivery of access is determined by the legally correct, complete and trustworthy information provided by the applicant.

The applicant should therefore present the Competent National Authority with all the information concerning the genetic resource and its derivatives with which he is familiar or in a position to know at the time of presenting the application. This information shall include the actual and potential uses of the resource, its derivatives or intangible components, its sustainability and risks which could arise from accessing it.

Declarations made by the applicant and contained in the application or the contract, including their respective annexes, shall be in the form of sworn statements.

Article 23

Permits, authorizations and other documents supporting the research into, acquisition, supply, or transfer of biological resources, or other activities relating to them, neither determine, condition nor presume authorization of access.

Article 24

The use of genetic resources and their derivatives in biological areas or in ways harmful to the environment or human health is prohibited.

Article 25

Technology transfers shall take place according to the provisions of the legal ordinances of the Cartagena Agreement, complementary national provisions, and standards on biosafety and the environment approved by the Member Countries.

Access to and transfer of technologies protected by patents or other intellectual property rights shall be effected in accordance with subregional and national complementary provisions regulating such matters.

Chapter II

Application for access

Article 26

The procedure is opened on presentation of an application for access to the Competent National Authority. This should contain the following:

(a) Identification of the applicant and, as appropriate, documents demonstrating that he is legally entitled to enter a contract;

(b) Identification of the supplier of genetic or biological resources and their derivatives or of the associated intangible component;

(d) Identification and curriculum vitae of the project manager and working group;

(e) Nature of the access activity being requested;

(f) Locality or area in which access will be made, together with the geographical coordinates.

The application should be accompanied by the project proposal, taking into account the reference model approved by the Board in the form of a resolution.

Article 27

If the application and project proposal are complete, the former will be declared admissible by the Competent National Authority, which will give a date for its presentation or establishment, register it in the official record and, by way of declaration, in the public record maintained by the same authority, and open the corresponding file.

If the application is found to be incomplete it will be returned without further delay, indicating the missing information, so that it can be completed.

Article 28

Within five working days of the date of inscription of the application in the public record referred to in the previous article, an extract of the application shall be published in a written medium of social communication with a wide national circulation and in another medium of communication in the locality where access activities are to take place, so that any person wishing to do so may submit information to the Competent National Authority.

Article 29

The Competent National Authority shall evaluate the application within 30 working days of its registration, effecting any visits which it may consider necessary and issuing a technical and legal report on the suitability or unsuitability of the project. This period may be extended to a maximum of sixty working days, at the discretion of the Competent National Authority.

Article 30

On expiry of the period indicated in the previous article, or before, as may be the case, the Competent National Authority shall either accept or reject the application, based on the results of the report, visit protocols, information supplied by third parties and compliance with the conditions specified in this decision.

Once the application and project proposal have been accepted, the applicant will be notified within five working days of the decision and may proceed to the negotiation and drafting of the access contract.

Should the application and project proposal be rejected, the decision will be communicated in the form of a motivated resolution and the procedure thereby terminated, without prejudice to its contestation under any relevant procedures established in the internal legislation of the Member Countries.

Article 31

The applicant should comply with the applicable environmental regulations in cases where this is required under the legislation of the Member Country or if the Competent National Authority deems it necessary to do so.

The procedures to be followed in this respect shall be independent of those established in this decision and may be started ahead of time. Nevertheless, they should be completed before elapse of the period indicated in article 29 and taken into consideration by the Competent National Authority in its evaluation.

In the event of such studies being required by the Competent National Authority, the latter may grant the applicant an extension based solely on the amount of time necessary to complete such studies and submit them for consideration.

Chapter III

The access contract

Article 32

The following shall be parties to the access contract:

(a) The State, represented by the Competent National Authority; and

(b) The applicant for access.

The applicant should be legally entitled to enter a contract in the Member Country in which access is requested.

Article 33

The terms of the access contract should comply with the contents of this decision and the national legislation of the Member Countries.

Article 34

The access contract shall take into consideration the rights and interests of suppliers of genetic resources and their derivatives, and of biological resources and their intangible components, in acordance with the relevant contracts.

Article 35

When access is requested to genetic resources or their derivatives with an intangible component, the access contract shall include, as an integral part of the same, an annex providing for the fair and equitable distribution of the benefits arising from the use of said component.

The annex shall be signed by the supplier of the intangible component and the applicant for access. It may also be signed by the Competent National Authority, subject to the provisions of the Member Country's national legislation. If the 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 terms of the annex shall be grounds for termination and annulment of the access contract.

Article 36

The Competent National Authority may establish framework access contracts with universities, research centres or recognized researchers, supporting the implementation of various projects, as outlined in this decision and in accordance with the national legislation of each Member Country.

Article 37

Ex-situ conservation centres or other bodies carrying out activities involving access to genetic resources, their derivatives or, as applicable, their related intangible component, should sign access contracts with the Competent National Authority, pursuant to this decision.

Similarly, the Authority may sign access contracts with third parties in connection with genetic resources for which the Member Country is also the country of origin and which have been deposited in such centres, taking into account the rights and interests referred to in article 34.

Chapter IV

Delivery of access

Article 38

Once the contract has been adopted and signed, the corresponding resolution shall simultaneously be issued and published, together with an extract of the contract, in the official journal or gazette or in a daily newspaper of extensive national circulation. From this moment on, access shall be understood to have been delivered.

Article 39

Contracts signed in violation of the provisions of this system shall be void. The annulment process shall be subject to the internal provisions of the Member Country in which it takes place.

Article 40

Rescission or closure of the contract shall result in ex officio cancellation of the record by the Competent National Authority.

Title VI

Accessory contracts to the access contract

Article 41

Accessory contracts are those signed for the purposes of developing activities connected with access to a genetic resource or its derivatives between the applicant and:

(a) The owner, holder or administrator of the property on which the biological resource containing the genetic resource is found;

(b) The ex-situ conservation centre;

(d) The national support institution, in connection with activities which it is to carry out and which are not included in the access contract.

Establishment of an accessory contract does not authorize access to the genetic resource or its derivative and its contents remain subject to that of the access contract, as established in this decision.

The national support institution must be accepted by the Competent National Authority.

Article 42

Any accessory contracts signed shall include a suspensive condition rendering their delivery subject to that of the access contract.

From this point onwards, they shall enter into effect and become binding, being governed by the terms mutually agreed, the contents of this decision and applicable subregional or national legislation. Responsibility for their execution and fulfilment lies solely with the parties bound by the contract.

Article 43

Without prejudice to the agreements contained in the accessory contract and regardless of these, the national support institution shall be required to collaborate with the Competent National Authority in following up and monitoring the genetic resources concerned, their derivatives or synthesized products and related intangible components, and submitting reports on the activities which it is responsible for or in charge of, the form and periodicity of these to be decided by the Authority, depending on the access activity involved.

Article 44

Annulment of the access contract causes the annulment of the accessory contract.

Similarly, the Competent National Authority may terminate the access contract on declaring the accessory contract void, if the latter is indispensable for effecting access.

Likewise, its modification, suspension, rescission or closure may lead to the modification, suspension, rescission or closure of the access contract by the Competent National Authority, if the terms of the latter contract are substantially affected by such action.

Title VII

Limitations of access

Article 45

The Member Countries may establish, under express legal measure, partial or total limitations on access to genetic resources or their derivatives in the following cases:

(a) Endemism, rarity or threat of extinction of species, subspecies, varieties or breeds;

(b) Conditions of vulnerability or fragility in the structure or function of ecosystems, likely to be aggravated by access activities;

(d) Access activities likely to have undesirable or hard-to-control environmental impacts on ecosystems;

(e) Danger of genetic erosion due to access activities;

(f) Regulations governing biosafety; or

(g) Genetic resources or geographical areas classified as strategic.

Title VIII

Infractions and penalties

Article 46

Any person engaging in access activities without the necessary authorization shall be penalized.

Likewise, any person engaging in transactions involving derivatives or synthesized products of such genetic resources or the related intangible product, and whose activities are not supported by the respective contracts signed in accordance with the terms of this decision, shall be penalized.

Article 47

The Competent National Authority may, using the procedure established under its own internal statutes, apply administrative sanctions such as fines, preventive or final confiscation, temporary or final closure of establishments and disqualification of the infractor from requesting new access, in cases of infraction of the present system.

Such penalties shall be applied without prejudice to the suspension, cancellation or annulment of access, payment of compensation for damages and injuries caused, including to biological diversity, and any civil and penal sanctions which may be applicable.

Title IX

Notifications among Member Countries

Article 48

The Member Countries shall notify each other immediately, through the Board, of all applications, resolutions and authorizations of access and of the suspension and termination of contracts signed.

Likewise, they shall notify each other of any bilateral or multilateral agreements signed in relation to the subject. Such agreements must comply with the terms of the present decision.

Article 49

Without prejudice to the terms of the previous article, the Member Countries shall immediately inform each other, through the Board, of any internally adopted measures, decisions, regulations, decrees, resolutions and other standards or acts with any bearing on the present decision.

Title X

The Competent National Authority

Article 50

The Competent National Authority shall exercise the faculties conferred on it by this decision and by the internal legislation of the Member Countries. In this respect, it shall be empowered to:

(a) Take internal administrative measures necessary to the implementation of this decision and, until such time as the corresponding community standards are established, determine the form in which genetic resources and their derivatives are to be identified and packaged;

(b) Receive, evaluate, accept or reject applications for access;

(d) Safeguard the rights of suppliers of biological resources containing genetic resources and their intangible component;

(e) Keep the technical files and public record of access to genetic resources and their derivatives;

(f) Keep a directory of persons or institutions qualified to carry out scientific or cultural support activities;

(g) Modify, suspend, terminate or rescind access contracts and arrange for their cancellation, as necessary, in accordance with the terms of such contracts, this decision and the legislation of the Member Countries;

(h) Give its informed objection to the suitability of the national support institution proposed by the applicant and request its substitution by another suitable institution;

(i) Supervise and monitor compliance with the terms of contracts and the contents of this decision, establishing for the purpose any follow-up and assessment measures that it deems necessary;

(j) Review, pursuant to this decision, contracts granting access which have already been signed with other bodies or persons and pursue any corresponding claims;

(k) Delegate supervisory activities to other bodies, retaining responsibility for and direction of such supervision, subject to its internal statutes;

(l) Supervise the state of conservation of biological resources containing genetic resources;

(m) Permanently coordinate, together with its respective liaison bodies, matters relating to compliance with the present decision;

(n) Keep a national inventory of genetic resources and their derivatives;

(o) Maintain permanent contact with the competent national intellectual property offices and establish appropriate information systems with them; and

(p) Other functions assigned to it under the internal legislation of the Member Country.

Title XI

The Andean Committee on Genetic Resources

Article 51

An Andean Committee on Genetic Resources is hereby created, comprising the directors of the Competent National Authorities on access to genetic resources, or their representatives, advisors, and representatives of other sectors concerned, as designated by each Member Country.

The Committee shall be responsible for:

(a) Issuing recommendations on improving compliance with this decision, at national and subregional level;

(b) Issuing technical recommendations on matters submitted to it for consideration by the Member Countries;

(c) Recommending mechanisms for the establishment of an Andean information network on access requests and contracts in the subregion;

(d) Recommending and proposing joint capacity-building actions for the Member Countries in the areas of research, management and transfer of technology connected with genetic resources and their derivatives;

(e) Recommending common models of documentation to the Board for adoption by resolution, particularly those enabling easy checking of the codification and identification of genetic resources and their derivatives and legality of access to them;

(f) Promoting actions to manage, monitor, control and supervise authorizations of access to genetic resources and their derivatives found in two or more Member Countries;

(g) Recommending and promoting joint early warning mechanisms and emergency plans to prevent or resolve problems connected with access to genetic resources and their derivatives;

(h) Taking cooperative action on matters relating to genetic resources or their derivatives;

(i) Drafting its own internal regulations

(j) Drafting an explanatory guide to this decision;

(k) Any other tasks entrusted to it by the Member Countries.

COMPLEMENTARY MEASURES

First:

The Member Countries shall, subject to their internal legislation, create or strengthen funds or other types of financial mechanism based on the benefits arising from access and resources from other sources, with the aim of promoting compliance with the terms of the present decision, to be managed by the Competent National Authority.

The Member Countries, through the Andean Committee on Genetic Resources, shall design and implement joint programmes to conserve genetic resources and shall assess the feasibility and appropriateness of creating an Andean Fund for the conservation of such resources.

Second:

The Member Countries shall not recognize any rights, including those of intellectual property, to genetic resources, derivatives, synthesized products or related intangible components obtained or developed on the basis of any access activity which does not comply with the terms of this decision.

Furthermore, the Member Country concerned may request annulment and take any necessary legal action in countries which have conceded rights or granted protective titles.

Third:

National offices competent to handle intellectual property matters shall, in cases where they have reasonable or concrete evidence that the products or processes for which protection is being requested have been obtained or developed from genetic resources or their derivatives for which any of the Member Countries is a country of origin, require applicants to submit the registration number of their access contract and a copy of the same, as a prerequisite for the concession of the respective rights.

The Competent National Authority and the national offices competent to handle intellectual property matters shall establish systems for exchanging information on authorized access contracts and concessions of intellectual property rights.

Fourth:

Health certificates supporting the export of biological resources, issued pursuant to Decision 328 of the Commission, and any modifications or connected texts, shall bear the following inscription at the foot of the document: "Not authorized for use as a genetic resource".

Fifth:

The Competent National Authority may establish contracts with institutions referred to in article 36 for the deposit of genetic resources, their derivatives or biological resources containing them, for purely custodial purposes, such resources remaining under its jurisdiction and control.

Similarly, the authority may establish contracts other than for access, such as intermediary or administrative contracts, in connection with genetic resources, their derivatives or synthesized products, provided such contracts are compatible with the terms of this system.

Sixth:

When access is requested to genetic resources from protected areas, or their derivatives, the applicant must, in addition to complying with the terms of this decision, comply with any national legislation specifically covering such areas.

FINAL MEASURES

First:

Disputes arising among the Member Countries shall be resolved according to the provisions of the Andean legal ordinances.

Solution of disputes arising with third countries shall be reached in accordance with the terms of this decision. In the event of a dispute arising with a third country which is also a Contracting Party to the Convention on Biological Diversity, signed on 4 June 1992 in Rio de Janeiro, the solution reached should also observe the principles established in the above Convention.

Second:

When negotiating the terms of contracts providing access to genetic resources or their derivatives for which more than one Member Country is a country of origin, and in carrying out activities related with such access, the Competent National Authority shall take into account the interests of other Member Countries, which may present their views and whatever information they deem most relevant.

Third:

The Board may, based on a resolution and prior opinion from the Andean Committee on Genetic Resources, perfect or adjust by resolution the procedure described in Chapters I and II of Title V of this decision.

Fourth:

This decision shall enter into force on the date of its publication in the Official Journal of the Agreement.

INTERIM MEASURES

First:

All those who, on the date on which this decision enters into force, are in illegal possession, for purposes of access, of genetic resources for which the Member Countries are countries of origin, their derivatives or related intangible components, must negotiate such access with the Competent National Authority, subject to the terms of this decision. The Competent National Authorities shall establish deadlines for such negotiation, not to exceed twenty-four months from the entrance into force of this decision.

In the event of non-compliance with this requirement, the Member Countries may disqualify such persons and the bodies which they represent or on whose behalf they are acting from applying for further access to genetic resources or their derivatives in the subregion, without prejudice to application of the corresponding penalties once the period referred to in the previous paragraph has elapsed.

Second:

Any contracts or agreements entered into between the Member States or their public or state bodies and third parties in connection with genetic resources, their derivatives, the biological resources in which they are found or intangible components thereof and which are not brought into line with this decision, may be renegotiated or not renewed, as befitting.

Renegotiation of such contracts or agreements and signature of new ones shall take place as agreed among the Member Countries. The Andean Committee on Genetic Resources shall establish common criteria for the purpose.

Third:

The Member Countries may take any legal action that they deem appropriate to reclaim genetic resources, derivatives and related intangible components for which they are countries of origin and to obtain any indemnities and compensation that may be due.

Claims made in respect of genetic resources and their derivatives may be only be presented in the name of the State.

Fourth:

The Board shall, based on a resolution and prior opinion of the Andean Committee on Genetic Resources, establish the necessary identification and packaging systems for genetic resources and, as necessary, their derivatives.

Fifth:

Each Member Country shall designate a Competent National Authority on access to genetic resources and accredit it before the Board within 30 working days of the date on which this decision enters into force.

Sixth:

The Member Countries shall present to the Board their accredited representatives to the Andean Committee on Genetic Resources within 30 working days of the date on which this decision enters into force.

Seventh:

The Member Countries shall adopt a common system on biosafety, within the framework of the Convention on Biological Diversity. To this end, the Member Countries, in coordination with the Board, shall undertake the necessary studies, particularly in connection with transfrontier movement of modified living organisms engineered by biotechnology.

Eighth:

The Board shall draft a proposal, within three months of national studies having been presented by the Member Countries, to establish a special system or harmonization standard, as appropriate, to provide greater protection of the knowledge, innovations and traditional practices of indigenous, afro-american and local communities, pursuant to article 8 of the present decision, article 2A of International Labour Organisation (ILO) Agreement 169 and article 8(j) of the Convention on Biological Diversity.

To this end, the Member Countries should submit their respective national studies within one year of the entrance into force of this decision.

Ninth:

The Member Countries shall design a training programme for indigenous, Afro-American and local communities, to enhance their negotiating capacities in relation to intangible components, within the framework of access to genetic resources.

Tenth:

The Board shall adopt by resolution the reference models for applications of access to genetic resources and access contracts, within a period not exceeding 15 days from the date on which this decision enters into force.

Done at Caracas, Venezuela, July 2, 1996.