Peru

Bill to Regulate Access to Genetic Resources (14-15 January 1999, with modifications made 10 March 1999)

Unofficial Private Translation

Title I — Definitions

Article 1. The following definitions apply to this Regulation:

authorization of access. This Resolution issued by the Competent National Authority permits access to genetic resources and their derived products, after fulfilling all the requirements established by Decision 391 and this Regulation.

indigenous populations.

Native Communities: They have origins in tribal groups of the forest and edge of the forest and are constituted as family ties with the following principle elements: idiom or dialect, cultural and social characters, common and permanent tenancy and use of their territory, with nuclear or dispersed establishments.

Campesino Communities. They are public interest organizations, with legal existence and juridical identity, integrated by families that live and control determined territories, with ancestral, social, economic and cultural ties, expressed in communal property, communal work, and mutual assistance, democratic government, and multisectoral development activities which aim to orient to the full realization of their members and the country.

Indigenous Communities. In conformity with Convention 169 of the International Labor Organization for Indigenous and Tribal Peoples, whose social, cultural, and economic conditions are distinguished from other sectors of the collective and that are total or partially prevailing of their customs or for special legislation. Those included in ethnic groups with no contact and that have not been integrated are legally recognized communities.

To effect the present provision, all references to the phrase "indigenous populations" are intended to mean native communities, campesinas and indigenous communities.

Contract of Access Framework. The form of contract for accessing genetic resources that consist in the inclusion of various projects of investigation and a single contract.

Provider of Genetic Resource. The person, institution, indigenous population or other entity within the framework of Decision 391 and the present regulation, that provides access to genetic resources. The State can be a provider of genetic resources.

Project of Access. Together with conforming documents, among others, the project to research genetic resources and derived products for which access is requested, and as the case may be, the accords, agreements, contracts, and other equivalent documents signed between the parties involved in the access.

Title II — Objective

Article 2. The present Supreme Decree establishes the complementary norms for the application of Decision 391 of the Commission of Cartagena Agreement on the Common Regime of Access to the Genetic Resources.

Title III — General Provisions

Article 3. The present Regulation prioritizes the transfer and application of technologies that use genetic resources of the country, that do not cause damage to the environment, and that are pertinent to conservation and sustainable use of biological diversity, according to article 3 of Law 26839.

In addition, this regulation prioritizes the development of projects that investigate the identification, registration, characterization, conservation and sustainable use of genetic resources, that contribute to the satisfaction of national needs as well as the development of programs of technical and scientific capacity in information, control and evaluation of activities related to genetic resources.

Article 4. The framework contract of access referred to in article 36 of Decision 391 can be created with universities and research centers located within the country and must specify the projects which they will undertake. These contracts must comply with the Title V of the present regulation.

By means of transfer accords with ex situ conservation centers domiciled in the country that acquire genetic material originating in Peru, from which new varieties, products and/or intellectual property rights are generated; they must contribute to the Peruvian State 2.5% of the profits resulting from the commercial or industrial use of those resources.

Article 5. In the case of universities and research centers that undertake commercial activities and which use acquired material or transfer it for such purposes, they must first sign an access contract with the Competent National Authority.

Universities and Research Centers must register with the Competent National Authority.

The non-compliance of universities and research centers with the previous paragraphs will be sanctioned in conformance with Article 28 of the present regulation.

Article 6. Indigenous populations have the ability to decide about intangible components associated with biological and genetic resources and their derived products.

The use by third parties of these components will be governed by the Special Regime of Protection of the Knowledge of Indigenous Populations.

In addition, access to genetic resources located in the territory of indigenous populations requires their express consent to undertake access activities and notification of the Ministry of Women and Human Development.

Title IV — Access Procedure

Article 7. The access procedure requires the presentation, admission, publication, and evaluation of a request, the signing of a contract of access, and the entry into force of a corresponding resolution that authorizes or denies the access.

Article 8. All the documents relating to the access procedure will appear in a file published by the Competent National Authority.

Article 9. The Competent National Authority can make confidential information in the request and those data and information that are presented during the access procedure or the execution of the access procedure, which had not been disclosed and that could be the object of unfair commercial use by third parties, except when public disclosure of this information is necessary to protect social interests or the environment.

Article 10. If the petition for confidential information does not comply with the requirements established in the previous article and Article 19 of Decision 391, the Competent National Authority will deny the entire right.

Article 11. The request for access presented to the Competent National Authority must contain the following:

a) the identification of the requester

b) identification of the provider of the genetic resources and, as may be the case, the associated intangible component;

c) identification of the national support institution;

d) identification of the responsible technical person of the project of access and the resume of experience of this person.

e) identification of the involved parties in the access project

f) identification of the geographic area in which access is sought;

g) terms of collection; and

h) a copy of the complete and detailed access project, in which the precise activities of access are established.

The request and the accompanying documents must be written in Spanish.

Article 12. An extract of the request must be published in the Official Journal of Peru and in a publication of local circulation in the area in which access is requested. Those interested parties have 15 days to present their observation about the project to the Competent National Authority.

Article 13. Once evaluated and approved, the involved parties of the access project must, as the case may be, create accessory contracts (accords, agreements, contracts and other equivalents) and/or a contract or license to use collective knowledge associated with the same.

Finally, a contract of access with the Competent National Authority must be created, which must verify the compliance of the conditions of access established in Decision 391 and this Regulation.

Article 14. The National Support Institution must be approved by the Competent National Authority and is obliged to collaborate with the Competent National Authority in activities of implementation and control of genetic resources, products, and derived or synthesized products and associated intangible components and to present periodic reports relating to activities within their charge and responsibility, as the authority determines.

Article 15. The access project referred to in paragraph h) of article 11 must contain, at a minimum, a copy of the accessory contracts (accords, agreements, contracts and other equivalents) that are established between involved parties, whose content can freely be agreed to between the parties in the access project, without prejudice to the provisions of article 21 of this Regulation.

Article 16. When advisable, the Competent National Authority can solicit an environmental impact assessment that guarantees that the access activities do not create adverse impacts.

Article 17. The access procedure finalizes with the issuance of a resolution issued by the Competent National Authority, which perfects the access contract and authorizes access to genetic resources. This resolution enters into force the day following publication in the Official Journal "El Peruana."

Prior to the issuance of the resolution indicated above, the Competent National Authority will present for the knowledge and put to the disposition of the members of the National Commission on Biological Diversity (CONADIB) all the documentation referred to in the access project. The members of CONADIB have a period of 15 days to review this documentation and to remit to the Competent National Authority their observations, which will be evaluated at the time of decision.

Article 18. One can only obtain and use genetic resources and their derived products, once the resolution referred to in the previous article has entered into force.

Article 19. The authorization of access implies the prior informed consent of the State and the corresponding resolution is the instrument that provides/authorizes the legal source of acquire genetic resources.

Article 20. The Competent National Authority will make a public registry of declarative character.

Title V — The Conditions of Access

Article 21. The accords, agreements, contracts and other equivalent documents that are established by the involved parties to the access project must contain the following minimum conditions:

a) the participation of national professionals in the collection and investigation of the genetic resources their derivatives and the gathering of data.

b) the commitment to transfer scientific and technical knowledge resulting form the activities tied to access;

c) the strengthening and development of institutional capacity of the national support institution and the provider of genetic resources by means of, among other things, capacity, equipment and infrastructure.

d) the commitment to put the knowledge of the Competent National Authority, advanced results and general publications that are part of the investigations undertaken, in Spanish. As the case may be, credit the entity that is working on the accessed material

e) the establishment of modalities and restrictions for the transfer of accessed material to third parties.

f) the related clauses to the eventual intellectual property rights concerning the processes and products resulting from the use of the genetic resources and derivatives.

g) the obligations about exclusivity and confidentiality.

h) the commitment to pay a percentage to the state, represented by the Competent National Authority, as referred to in article 23.

i) the provision of information about previous work, the state of the science and other things, that contribute to the better knowledge of the situation related to the genetic resource their derived or synthesized product, and associated collective knowledge, in and out of the national territory.

j) the provision of sufficient information related to the purposes, rules, and implications of these activities, including the eventual use of the resource, and, as the case may be, the value of the resource.

k) clauses related to the payment for gathering, as well as clauses relative to payments to the provider of the resource for each sample obtained; and

l) the obligatory deposit of duplicates of all collected material in an institution authorized by the Competent National Authority; leaving with unique samples and holotypes is expressly prohibited.

Article 22. The accords, contracts, agreements, and other documents referred to in the previous article can include conditions relating to support for research in the national territory that contributes to conservation and sustainable use of biological diversity.

Article 23. The Competent National Authority, as representative of the State, will receive 5% of the value of the transaction agreed between the provider of the resources and the requester.

In addition, it will receive 2.5% of the gross margin of profit resulting from the commercial or industrial use of genetic resources and their derivatives, as the case may be.

These benefits do not include those generated as part of the use of intangible components.

These funds are destined for the Fund for Conservation and Development of Genetic resources that is referred to in Title IX of this regulation.

Article 24. The Competent National Authority must verify that the conditions of access established in article 21 are being incorporated in accords, agreements, contracts and other equivalents that are established between involved parties to the access project.

Passed the term referred to in article 17 of this Regulation, the Competent National Authority will perfect the access contract and authorize the access to genetic resources, within 30 days.

Title VI — Limitations on Access

Article 25. The Competent National Authority will deny all or partial access to genetic resources and their derived products, in cases in which there exists an issued resolution for the competent sectoral authority in respect to the assumptions established in article 45 of Decision 391 and article 29 of Law 26839.

Title VII — Infractions and Sanctions

Article 26. The enforcement of the obligations of Decision 391 and this Regulation is the duty of the Competent National Authority. To this end, the Competent National Authority will issue and publish a corresponding resolution.

Article 27. It constitutes an infraction of the present regulation to undertake access activities of genetic resources or transactions related to derived products that are not protected by the access authorization.

Article 28. The sanctions anticipated by the Resolution are:

a) a warning;

b) suspension of the authorization of access;

c) cancellation of the authorization of access;

d) confiscation of material accessed in contravention of the present Regulation;

e) a fine up to a maximum of 1000 Unidades Impositivas Tributarias;

f) incapacitation of the violator's to present a new request for access;

g) cancellation of the entity's registration

These sanctions can be applied separately or together, depending on the infraction committed, independently of civil and penal sanctions that arise, taking into account the following criteria:

a) endemic species and the grade of endemism;

b) threatened species included on the official list;

c) species with a high grade of endangerment by overutilization or reduced habitat;

d) alteration in the structure of the population of the species or the ecosystem;

e) falsified facts or collection, extraction, or exportation, of identification of authorized species or associated intangible components;

f) methodologies or technical things that alter or degrade the environment or the ecological conditions;

Title VIII — The Competent National Authority

Article 29. The National Commission of Genetic Resources (CONARGE) is created, a multi- sectoral entity whose purpose is the planning, promotion, coordination, enforcement of compliance with Decision 391 and this Regulation, and the norms and provisions related to access to genetic resources; it will be the Competent National Authority.

Article 30. Comprising CONARGE is a representative of the Ministry of Research, IMARPE, Ministry of Agriculture, INRENE, y INIA. It will count on the Consultative Council, managed by the National Commission of Biological Diversity (CONADIB) of the National Environmental Council (CONAM).

The charge of the president of CONARGE is the management of the rotating form between the representatives of the Institutions that constitute CONARGE. The president will sit for a period of two years.

Article 31. CONARGE includes an Executive Secretary that will be within the National Institute of Natural Resources (INRENA).

Article 32. CONARGE has the following functions:

a) to propose to the relevant authorities of the government the adoption of the measures that judge necessary to guarantee the compliance with Decision 391 and this Regulation.

b) to delegate activities to other entities, while maintaining responsibility for them;

c) to approve:

1) annual institutional work plans;

2) the mechanisms for monitoring and evaluation;

3) the requirements and procedures for the recognition of institutional capacity to evolve as the national support institution.

4) the requirements and procedures to recognize the technical-scientific suitability of the project.

d) to perfect the access contract and to issue the corresponding resolution that authorizes access to genetic resources, having the technical information that is referenced in article 34 of this Regulation.

e) to cancel or suspend the authorization when there is non-compliance with the minimum conditions established in Decision 391 and this Regulation based on the conditions it is conceded the authorization of access.

f) to solicit the opinion of CONADIB before perfecting access according to the rules established in article 17 of this regulation.

g) to describe the institutions that can be national support institutions;

h) to impose sanctions according to the present regulation, with previously informing the Executive Secretary; and

i) to administer under responsibility their resources, and

j) to administer the Fund for Conservation and Development of Genetic Resources.

Article 33. The Executive Secretary of CONARGE has the following essentially administrative functions:

a) to receive, admit, and declare inadmissible requests for access;

b) to supervise and control compliance with Decision 391 and this Regulation;

c) to propose to CONARGE the mechanisms for monitoring and evaluating that it considers convenient, based on proposals from pertinent organizations;

d) to propose to CONARGE access requests and the documentation presented and solicit technical information that is referenced in article 34 of this Regulation.

e) to administer technical files;

f) to conduct and maintain the Public Registry of Access to Genetic Resources and their derived products;

g) to maintain a register of institutions that are described as having unctions of national support institutions.

h) to propose to CONARGE the cancellation and suspension of the authorization of access conforming to this regulation.

i) to maintain permanent contact with INDECOPI and with competent national offices in intellectual property of other countries, establishing with them systems of exchange of proprietary information about authorizations and intellectual property rights granted to products and processes tied to genetic resources.

j) to propose to CONARGE adminsitrative sanctions in Title VII of this Regulation. To this end, of necessary consideration, it is to request a technical report from the entities that are referred to in article 34.

k) to elaborate the institutional work plan project and its annual notes;

l) to maintain permanent contact with the focal point of the Convention on Biological Diversity in regards to information relating to the application of article 15 of that Convention; and

m) others functions that CONARGE assigns.

Article 34. The technical reports necessary to evaluate, approve, and authorize access requests and projects, must be elaborated by those entities of the accord in the nature of resources that are being requested.

a) in case of genetic resources and their derived processes of wild continental species, the competent technical organization is INRENA;

b) in the case of genetic resources and their derivatives originating from domesticated continental species, the competent technical organization is INIA;

c) in the case of genetic resources and their derivatives originating from hydrobiological species, the competent technical organization is the Ministry Fisheries and IMARPE;

Article 35. The resources of CONARGE are:

a) the amounts that are assigned, for such aim, in the budgets of the Republic, of INRENA, in the quality of the Executive Secretary;

b) the fees generated by the rights to request access; and

c) a maximum of 50% of the annual interest generated by those financial resources of the Fund of Conservation and Development of Genetic Resources that are referred to in Article 36;

d) others that are assigned.

Title IX — The Fund of Conservation and Development of Genetic Resources

Article 36. It is created the Fund of Conservation and Development of Genetic Resources, administered by CONARGE for the support of projects relating to the conservation and use of genetic resources.

Article 37. The financial resources of the fund are provided by:

a) donations, legacies, and resources provided by persons, national and foreign and of International Cooperation.

b) the amounts that are referred to in article 23 of this Regulation; and

c) the amounts provided in the application fees that are referred to in article 28 of this regulation.

Complementary Provisions

FIRST. - In case it is requested a patent of invention or certificate obtained for a plant variety relating to products or processes obtained or developed in part of genetic resources and their derived products, of which Peru is the country of origin, the requester is obligated to present a copy of the authorization of access, as the previous requirement for the concession of the respective right. The breach of this obligation will be cause for denial, or as the case may be, the nullification of the patent of the certificate [de obtentor] in question.

SECOND. When access to genetic resources originating in protected areas is requested, the requestor, in addition to the provisions contemplated by this regulation, must be in compliance with national legislation specific to protected areas, in conformance with Law 26834.

THIRD. The permissions, authorizations, and additional documents that are granted by public entities such as INRENA, INIA, or MIPE and that protect the investigation, obtencion provision, transfer, and others, of biological resources, with different purposes for their use as a source of resources through for accessing indirectly genetic resources, it is neither to be determined, condicionan nor to be presumed the authorization of access.

FOURTH. CONARGE, in coordination with the National Superintendent of Customs, must adopt the measures necessary to impede the illicit export from the country of genetic resources regulated by Decision 391 and this regulation.

FIFTH. It is prohibited to use genetic resources in biological weapons and practices that harm the environment and human health.

Transitory Provisions

FIRST. Persons and institutions, including ex situ conservation centers, that of the date of entry into force of this regulation, hold as owners any genetic resources, must present a report about their technical and legal situation within 12 months of this date. Passed the indicated term, without having presented the report, they cannot acquire any type of genetic resource nor transfer such resources to a third party.

SECOND. The contracts or agreements that the public entities or private nationals have signed with third parties regarding genetic resources, their derived products or biological resources that contain them, that does not adjust to Decision 391 or this Regulation, must adapt to the present regime in 12 months of entry into force of this Regulation, and if in non-compliance there will be a sanction as indicated in Article 28.

THIRD. In a term not greater than thirty days capable of being counted as of the date of entrance of this Regulation, the President of the Council of Ministers, the Minister of Agriculture and of Fisheries will designate by Supreme Resolution to each one of the members of CONARGE.

FOURTH. The Minister of Economy and Finance will transfer economic resources to INRENA for the functioning of CONARGE and the implementation of the Executive Secretary, within 30 countable days of the presentation of the institutional work plan.

QUINTA. The Minister of Health will form a commission to study the problems of access to human genetic resources and the pertinence of legislation to regulate it.