Ministerial Agreement 706-2021

Definitions. Access and utilization of genetic resources or their derivatives: Obtaining of genetic resources and their derivatives for conducting research and development activities, including through the application of biotechnology, in accordance with the definition stipulated in Article 2 of the Convention on Biological Diversity. Utilization of biological, genetic resources and derivatives: Obtaining and use of biological, genetic resources and derivatives as raw material, without added value through research and development, for their commercialization at national or international level. Biotechnology: Any technological application that uses biological systems and living organisms, or their derivatives, for the creation or modification of products or processes for specific uses. Internationally recognized certificate of compliance: Legal instrument internationally recognized by being made known at the Access and Benefit-sharing Clearing-House, which is administered by the Secretariat of the Convention on Biological Diversity. Commodities: Products that are commercialized and generally exported in larger quantities as raw material and include biological resources such as coffee, bananas, rice, wood or derivatives such as resins, latex or natural oils, among others. Conservation or in situ conditions: Conservation of ecosystems and natural habitats and the maintenance and recovery of viable populations of species in their natural environments and, in the case of domesticated and cultivated species, in the environments in which they have developed their specific properties. Conservation or ex situ conditions: Conservation of components of biological diversity outside their natural habitats. Contract for access to genetic resources and their derivatives: Agreement that, within the framework of an administrative procedure, is entered into by the State through the authorities with sectoral administrative competencies with an applicant seeking access to genetic resources and their derivatives. Said contract expresses mutually agreed upon terms and the prior informed consent of the national authority and determines the conditions of access and the benefits to be shared. Derivative: Biochemical compound that exists naturally produced by the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity. II. Scope of the regime for access and utilization of genetic resources and derivatives

Scope of application. This regulation applies to activities involving the access and utilization of genetic resources and their derivatives, whether these originate from in situ or ex situ conditions. In that sense, any natural or legal person that intends to access and utilize genetic resources or derivatives of Honduran origin, within or outside the national jurisdiction, must submit to the procedures and principles provided for in this regulation.

Exception. This regulation does not apply to the access and utilization of human genetic resources. III. General principles of access to genetic resources and their derivatives

Traditional uses and practices of indigenous peoples and local communities. Indigenous peoples and local communities that exchange and use genetic resources and their derivatives, in accordance with their practices, traditions and customary laws, shall not be bound by the provisions of this regulation. In cases where they conduct access and utilization activities of genetic resources and derivatives in association or collaboration with universities or companies, they shall be subject to the provisions of this regulation to the extent applicable to them and to the pertinent national or international legislation.

Utilization of biological, genetic resources and derivatives. The commercialization of biological, genetic resources or derivatives as "commodities", in commercialization chains or biocommerce, shall not be subject to the principles and provisions related to the access and utilization of genetic resources and their derivatives, except in cases where certain phases involve their access and utilization, as defined in Article 1 (Definitions) of this regulation.

Access in protected natural areas. In the case of activities involving access and utilization of genetic resources or their derivatives originating from protected natural areas, the procedures for access and utilization shall be carried out before the National Institute for Conservation and Development of Forests, Protected Areas and Wildlife (ICF).

Taxonomic or basic research. To the extent that activities of taxonomic or basic research do not involve access and utilization of genetic resources and their derivatives, they shall be governed by the existing regulations on the matter. If during the course of the taxonomic or basic research process new lines of work are initiated that were not originally foreseen or that involve access and utilization of genetic resources and their derivatives, the corresponding procedure shall be initiated before the Secretariat of Natural Resources and Environment (MiAmbiente) and within the framework of this regulation.

Traditional knowledge of indigenous peoples and local communities. When accessing traditional knowledge of indigenous peoples and local communities associated with genetic resources and their derivatives, the interested party or applicant must comply with the pertinent norms and provisions; the prior informed consent of such peoples and communities must also be obtained, through their representative organizations or corresponding government structures, in order to enter their lands and territories and carry out activities related to access and utilization of biological, genetic resources or derivatives. CHAPTER II IV. Of the competent national authority and authorities with sectoral administrative competencies in matters of access and benefit-sharing

The competent national authority. The Secretariat of Natural Resources and Environment (MiAmbiente+), through the General Directorate of Biodiversity (DIBIO), is the competent national authority in matters of access and utilization of genetic resources and their derivatives and the fair and equitable benefit-sharing. Likewise, it acts as the National Focal Point for the Convention on Biological Diversity and the Nagoya Protocol.

Functions of the competent national authority to implement the national regime based on the Nagoya Protocol. The Secretariat of Natural Resources and Environment (MiAmbiente+) has the following functions:

• a)

  Propose national policies and regulations on matters of access and utilization of genetic resources and their derivatives and fair and equitable benefit-sharing, in coordination with the authorities with sectoral administrative competencies and other entities with competencies converging with the utilization of genetic resources and their derivatives.

• b)

  Receive applications for access and utilization of genetic resources and their derivatives for their immediate channeling to entities with sectoral administrative competencies.

• c)

  Inform applicants about the other authorities with sectoral administrative competencies that will be evaluating their applications and about the procedure for access and utilization of genetic resources and their derivatives.

• d)

  Inform interested parties and applicants about the entities responsible for safeguarding the traditional knowledge of indigenous peoples and local communities, insofar as it could be relevant to their plans or projects for access and utilization of genetic resources and derivatives.

• e)

  Participate in international negotiations on matters of access to genetic resources and their derivatives, in coordination with other relevant national entities.

• f)

  Apply the procedure and contracts for access and utilization of genetic resources subscribed by the authorities with sectoral administrative competencies, through the corresponding resolution that certifies legal access and utilization and the moment from which the project for access and utilization of genetic resources and derivatives may be initiated and field activities or activities provided for in such projects may be carried out.

• g)

  Participate and provide support in the benefit-sharing negotiation processes carried out by the applicant and the authorities with sectoral administrative competencies.

• h)

  Provide assistance, guidance and information to interested parties on matters of access to genetic resources and their derivatives.

• i)

  Issue the resolution that certifies the legal access and utilization of genetic resources and derivatives in accordance with subsection f) of this Article 9 and communicate this to the Secretariat of the Convention on Biological Diversity for the generation of the internationally recognized certificate of compliance at the Access and Benefit-sharing Clearing-House.

• j)

  Notify the applicant of the resolution that perfects the contract and procedure for access and utilization of genetic resources.

• k)

  Strengthen, complement and improve the public information and data related to access and utilization of genetic resources in Honduras contained in the Access and Benefit-sharing Clearing-House and raise awareness among relevant sectors and actors about the existence and relevance of this Mechanism.

• l)

  Coordinate with the authorities with sectoral administrative competencies the audit and monitoring procedures regarding compliance with the conditions of access and utilization of genetic resources and their derivatives and the obligations agreed upon in the corresponding contracts and determine any infractions or sanctions that, in accordance with national legislation, could be applicable.

• m)

  Other functions that by the nature of their competencies and functions may be required for the fulfillment of this regulation.

Authorities with sectoral administrative competencies. The authorities with sectoral administrative competencies in matters of access and utilization are:

• a)

  The National Institute for Conservation and Development of Forests, Protected Areas and Wildlife (ICF), in the case of genetic resources and their derivatives originating from wildlife flora and fauna, including microorganisms found in forests and protected areas;

• b)

  The General Directorate of Fisheries and Aquaculture (SAG-DIGEPESCA), in the case of genetic resources and their derivatives originating from marine areas or continental bodies of water;

• c)

  The Directorate of Agricultural and Livestock Science and Technology (SAG-DICTA) in the case of Genetic resources and their derivatives of cultivated and domesticated species, especially for food and agriculture.

Functions of the authorities with sectoral administrative competencies. It is the responsibility of the authorities with sectoral administrative competencies to:

• a)

  Receive, analyze and process the application for access and utilization sent by the Secretariat of Natural Resources and Environment (MiAmbiente+) and notify the applicant of the response to it.

• b)

  Negotiate with the applicant, in coordination with the Secretariat of Natural Resources and Environment (MiAmbiente+), the terms of the contract for access and utilization of the corresponding genetic resources and derivatives and subscribe to it.

• c)

  Formally forward the contract for access and utilization of genetic resources and their derivatives and the corresponding documentation to the Secretariat of Natural Resources and Environment (MiAmbiente+) for approval of the same and of the procedure as a whole through resolution.

• d)

  Request from the Secretariat of Natural Resources and Environment (MiAmbiente+) and other entities, technical assistance and/or opinion on specific aspects of the negotiation of a contract for access and utilization of genetic resources. This includes members of the National Consultative Council on the Environment (COCONA), if applicable.

• e)

  Carry out the audit and monitoring processes of compliance with the provisions of the contract for access and utilization of genetic resources and their derivatives, in coordination with the Secretariat of Natural Resources and Environment (MiAmbiente+) when pertinent, and in special cases the National Consultative Council on the Environment (COCONA) shall be formed.

• f)

  Rescind the contracts for access and utilization of genetic resources and their derivatives in cases of non-compliance with the obligations and conditions agreed upon therein.

• g)

  Verify whether the project for access and utilization of genetic resources and their derivatives involves traditional knowledge of indigenous peoples and local communities. If so, ensure that it is incorporated as an annex to the access contract the document described in Article 12 of this Regulation.

• h)

  Other functions deemed necessary by the nature of their activities and competencies. V. Of the benefits and conditions of access and utilization of genetic resources and their derivatives

The contracting parties to the contract for access and utilization of genetic resources and their derivatives are the State, through the authority with sectoral administrative competencies, and the applicant for access or who in the corresponding access project will be defined as having this role. In the case of use of traditional knowledge of indigenous peoples and local communities as part of the projects for access and utilization of genetic resources and their derivatives, an annex shall be added to the access and utilization contract, which is an integral part thereof and where the conditions of access and use of such knowledge are specified, in accordance with the corresponding legislation.

The contracts for access and utilization of genetic resources and their derivatives must incorporate clauses that define benefit-sharing, including:

• a)

  The participation of national entities and professionals in research activities on genetic resources and their derivatives;

• b)

  The transfer of knowledge and technologies, including biotechnologies, that are culturally, socially and environmentally sound and safe and of special interest to Honduras;

• c)

  The supply of information to the General Directorate of Biodiversity (DIBIO) on background information, state of the science or other matters, for its dissemination and to contribute to a better understanding of the situation relating to genetic resources and their derivatives in Honduras;

• d)

  Training of national researchers related to genetic resources and their derivatives;

• e)

  The strengthening of capacity of indigenous peoples and local communities, including for a better understanding of the dimensions of the topic, better decision-making and to participate in a more informed manner in the decision-making processes related to utilization of traditional knowledge associated with genetic resources and their derivatives;

• f)

  Royalties, advance payments, installment payments and other monetary benefits that will be shared fairly and equitably among the Honduran State, the applicant/contractor and indigenous peoples and local communities, when in the latter case the access and utilization activities involve their lands and territories and their traditional knowledge associated with genetic resources and derivatives;

• g)

  Other matters that the Secretariat of Natural Resources and Environment (MiAmbiente+) and the authorities with sectoral administrative competencies deem relevant to incorporate in the contract for access and utilization of genetic resources and their derivatives. VI. Of the conditions of access

Every applicant must comply with the following conditions of access, which are imperative and non-negotiable, and include:

• a)

  Subsequent transfers of genetic resources and derivatives are governed by the obligations agreed upon in the contract for access to genetic resources and derivatives originally executed;

• b)

  Changes in use or applications of genetic resources and their derivatives must be urgently notified to the administrative authorities with sectoral competencies;

• c)

  The recognition of the origin and source of genetic resources and derivatives used, including cases of deposit in ex situ conservation centers, must be materialized in a written document included in the authorized access project or activity;

• d)

  The recognition of the origin of traditional knowledge associated with genetic resources and derivatives must likewise be documented in writing;

• e)

  Accessibility for Honduras public and private research institutions participating in access projects to the results of the research conducted on genetic resources and their derivatives;

• f)

  The mandatory deposit of duplicates of all collected material in national institutions of recognized prestige and, if applicable and technical options exist, in banks or community gardens of indigenous peoples and local communities, if collections were made in their lands or territories;

• g)

  Other conditions that the Secretariat of Natural Resources and Environment (MiAmbiente+) and the authorities with sectoral administrative competencies deem relevant to impose in accordance with the nature of the access project.

Audit and Monitoring. It shall be primarily the responsibility of authorities with sectoral administrative competencies to carry out regular audit and monitoring processes of the progress in the execution of access contracts and the compliance with their obligations and conditions, including through the review of progress reports that the applicant and its partners shall submit. However, in its role as competent authority and focal point in matters of access to genetic resources, the Secretariat of Natural Resources and Environment (MiAmbiente+) shall conduct audit and monitoring activities when it deems appropriate.

Rescission of the Contract for Access and Utilization of Genetic Resources and Derivatives. If during the execution of the access contract the authorities with sectoral administrative competencies verify non-compliance with their obligations, they may rescind it by giving reasoned notice to the contracting party with 30 business days' notice. Depending on the nature of the non-compliance, they may grant the contracting party a period not exceeding 60 business days to remedy the detected non-compliance and avoid rescission.

Steps of the Access Procedure. The procedure for access to genetic resources and their derivatives shall be carried out following the following steps:

• a)

  Submission by the applicant to the Secretariat of Natural Resources and Environment (MiAmbiente+) of the request for access and utilization of genetic resources and their derivatives, including the corresponding research project.

• b)

  Referral by the Secretariat of Natural Resources and Environment (MiAmbiente+) to the authority with sectoral administrative competence of the request and corresponding project.

• c)

  Evaluation of the request by the authority with sectoral administrative competence and its reasoned acceptance or rejection.

• d)

  Negotiation of the access and utilization contract between the authority with sectoral administrative competence and the applicant, with the participation of the Secretariat of Natural Resources and Environment (MiAmbiente+) and technical advisory bodies as required.

• e)

  Incorporation as an annex to the contract of the document that specifies the conditions for use of traditional knowledge of indigenous peoples and local communities, if applicable.

• f)

  Referral of the executed contract and supporting documentation to the Secretariat of Natural Resources and Environment (MiAmbiente+) for the issuance of the final resolution and formal notification to the applicant.

Deadlines. The Secretariat of Natural Resources and Environment (MiAmbiente+) shall refer the access request to the corresponding authority with sectoral administrative competence within a period of 15 business days: The administrative authority shall review the request and notify the applicant within a maximum period of 30 business days of receiving the request from the Secretariat of Natural Resources and Environment (MiAmbiente+). If the response to the request is positive, the parties shall proceed to negotiate an access and utilization contract for genetic resources between the authority with sectoral administrative competence and the applicant. For projects related to access and utilization for purposes of taxonomic or basic research, the period for this negotiation shall not exceed 30 business days. In the case of complex projects, the period shall not exceed 90 business days. Once the access contract is executed, the authority with sectoral administrative competence shall refer the contract and supporting documentation to the Secretariat of Natural Resources and Environment (MiAmbiente+) within a maximum of 10 business days for the issuance of the resolution that perfects the contract and procedure for access and utilization of genetic resources and their derivatives.

Research Abroad. If as part of the corresponding access and utilization project it is necessary to carry out research and development activities abroad and it is necessary to export genetic resources or their derivatives, compliance with sanitary regulations shall be required, in accordance with the standards established by the National Agricultural and Livestock Health Service (SAG-SENASA).

All activities of access and utilization of genetic resources obtained from ex situ conditions shall be carried out through a standardized material transfer agreement developed by the authorities with sectoral administrative competence in coordination with ex situ conservation centers, the Secretariat of Natural Resources and Environment (MiAmbiente+), and other relevant institutions. Said agreement shall be formally approved by the Secretariat of Natural Resources and Environment (MiAmbiente+). Only those ex situ centers duly registered with the Secretariat of Natural Resources and Environment (MiAmbiente+) shall be authorized to use this material transfer agreement.

Granting of Enabling Titles. Permits, authorizations, certifications, concessions, contracts, management plans, or other titles granted to use samples or components of Honduras's biodiversity do not authorize their holders to conduct activities of access and utilization of genetic resources or their derivatives.

Internationally Recognized Compliance Certificate. Once the resolution that perfects the procedure and contract for access to genetic resources and their derivatives is issued, the Secretariat of Natural Resources and Environment (MiAmbiente+), through the General Directorate of Biodiversity (DIBIO), shall refer to the Secretariat of the Convention on Biological Diversity such information and what is necessary for the generation of an internationally recognized compliance certificate through the Access and Benefit-sharing Clearing House.

Information for Certificate Generation. The Secretariat of Natural Resources and Environment (MiAmbiente+), through the General Directorate of Biodiversity (DIBIO), shall refer to the Secretariat of the Convention information related to, among others: (

• a)

  the authority issuing the resolution (

• b)

  date of issuance (

• c)

  the provider of genetic resources or derivatives (

• d)

  the person or entity to whom prior informed consent was granted (

• e)

  the matter or genetic resources covered by the access contract (

• f)

  confirmation that mutually agreed conditions have been established (

• g)

  confirmation that prior informed consent was obtained; and, (i) the type of intended utilization (commercial and/or non-commercial in nature). Such information may be included in the resolution through which the procedure and access contract are perfected or provided in a complementary manner. The Secretariat of Natural Resources and Environment (MiAmbiente+), through the General Directorate of Biodiversity (DIBIO), may keep in reserve information or data that the applicant/contractor requests be kept in this condition or such information that the Secretariat itself considers should be kept in this condition.

Verification Points on Access and Utilization of Genetic Resources and Their Derivatives. The verification points on access and utilization of genetic resources and their derivatives aim to contribute to the process of transparency, monitoring, and the identification of genetically accessed resources and legally used throughout the research and development chain.

Requirement for Disclosure of Origin and Legal Provenance in Intellectual Property. As part of its regular procedures for processing patent of invention applications, especially in the field of biotechnology inventions, the General Directorate of Intellectual Property (DIGEPIH) shall require the applicant to indicate the origin of the genetic resources and provide a copy of the corresponding access and utilization resolution issued by the Secretariat of Natural Resources and Environment (MiAmbiente+), or the equivalent document from competent authorities in matters of access and utilization of genetic resources of the countries of origin of the genetic resources and derivatives, if applicable. This same requirement shall be incorporated into legislation on plant breeder's rights and required by SAG-SENASA as part of the application procedure for protection of plant varieties.

Support in Verification from Science and Technology Entities. The Honduran Institute of Science, Technology and Innovation (IHCIETI) shall verify that in the financing of projects and activities in science, technology, and innovation that involve genetic resources or their derivatives from Honduras, compliance with the norms of access and utilization of genetic resources and their derivatives has been met, requiring applicants to provide a copy of the resolution issued by the Secretariat of Natural Resources and Environment (MiAmbiente+).

Non-Compliance. Whoever conducts activities of access and utilization of genetic resources and derivatives without having the corresponding resolution issued by the Secretariat of Natural Resources and Environment (MiAmbiente+) or in violation of the provisions of this regulation shall be subject to administrative sanctions. Violators are liable to one or more of the following sanctions, without prejudice to civil or criminal measures that may be considered:

• a)

  Annulment of the access resolution,

• b)

  Seizure of material accessed in contravention of this regulation,

• c)

  Fine to be determined by MiAmbiente+,

• d)

  Disqualification of the violator from submitting new access requests, and e) Prohibition from conducting access and utilization activities in the country again.

Criteria for Classification of Infraction. In classifying the infraction, the Authority of Administration and Enforcement shall take into account the gravity thereof, the socioeconomic condition of the violator, and their status as a recidivist, if applicable.

In accordance with their competencies and the mandate of Article 17.1 of the Nagoya Protocol, the DIGEPIH and the IHCIETI shall act as verification points in matters of access and utilization of genetic resources and their derivatives in accordance with Articles 25 and 26 of this regulation.

The Secretary of Natural Resources and Environment (MiAmbiente+), in coordination with authorities with sectoral administrative competencies, shall prepare within a period of 120 business days a model request for access and utilization of genetic resources and their derivatives and an access contract. Likewise, within 120 business days and with the participation of recognized ex situ centers, a model agreement or contract for transfer of material shall be prepared to access and utilize genetic resources and derivatives from ex situ conditions, other than those covered by the International Treaty of the FAO on Plant Genetic Resources for Food and Agriculture.

Based on their competencies, the National Institute for Conservation and Development of Forests, Protected Areas and Wildlife (ICF) is designated as the authority with sectoral administrative competence in the matter of access and utilization of genetic resources and their derivatives for the case of genetic resources and their derivatives from wild flora and fauna, including microorganisms found in forests and in protected areas; the General Directorate of Fisheries and Aquaculture (SAG-DIGEPESCA) for the case of genetic resources and their derivatives from marine zones and continental bodies of water; and the SAG, through DICTA, for the case of genetic resources and their derivatives of cultivated and domesticated species, especially for food and agriculture.

Within a period of 180 business days, the Secretary of Natural Resources and Environment (MiAmbiente+), in coordination with the General Directorate of Intellectual Property (DIGEPIH), the Executive Directorate of Culture and Art of the Office of the President of the Republic, the National Directorate of Indigenous and Afro-Honduran Peoples (DINAFROH), the Honduran Institute of Anthropology and History, and other entities with competencies in the matter, shall develop the bases to promote a process for elaboration of a sui generis norm related to the protection of traditional knowledge of indigenous peoples and local communities, which complements the provisions of this regulation as pertinent and which adequately responds to international advances in the matter.

This Ministerial Agreement shall enter into force one (1) day after its publication in the Official Gazette La Gaceta. Given in the city of Tegucigalpa, municipality of the Central District, on the twenty-sixth day of the month of April of two thousand twenty-one. COMMUNICATE AND PUBLISH. CARLOS PINEDA FASQUELLE Secretary of State, by Law in the Offices of Natural Resources and Environment Agreement No. 368-2021 NARCISO E. MANZANARES ROJAS General Secretary