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Act on Genetic Resources

The Act on Access and Utilization of Genetic Resources and Sharing of Benefits
(Abbreviated: Act on Genetic Resources)
Enforcement Date 2017.8.17

Chapter 1. General Provisions

Article 1 (Purpose)

The purpose of this Act is to provide for the implementation of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity and contribute to the conservation and sustainable use of biodiversity by promoting fair and equitable sharing of benefits arising from access and use of genetic resources with respect to traditional knowledge, and to improve the lives of the people and promote international cooperation

Article 2 (Definitions)

The definitions of terms used in this Act shall be as follows:

  • 1. “Genetic resources” shall have the meaning ascribed to in Article 2, Section 4 of the Act on the Conservation and Utilization of Biodiversity.
  • 2. “Traditional knowledge” means knowledge, technology and practice, etc. of individuals or local communities which have maintained a traditional life style appropriate for the conservation and sustainable use of genetic resources.
  • 3. “Access” means the collection of information regarding the acquisition of a specimen or substance of a genetic resource, or of a genetic resource and its associated traditional knowledge (collectively, “genetic resource(s)”).
  • 4. “Utilization”(or use) means to conduct, through the application of biotechnology, the research and development on the genetic and biochemical components of genetic resources.
  • 5. “Benefit” means monetary benefits, including but not limited to royalties and income, etc from the use of genetic resources non-monetary benefits, including but not limited to, sharing of research results and transfer of technology ,etc.

Article 3 (Applicability) This Act shall not apply if it applies to any of the following:

  • 1. Human genetic resources, etc.
  • 2. Genetic resources existing in area beyond national jurisdiction, such as Antarctica.
  • 3. Utilization of genetic resources for any other purpose than described in Article 1(4) above.
  • 4. Genetic resources that are subject to other international treaties related to the access of genetic resources and the sharing of benefits.
  • 5. Genetic resources that have been granted patents rights pursuant to Article 87(1) of the Patent Act.

Article 4 (Responsibilities of State)

  • (1) The State shall establish and implement policies necessary for systematic protection and management of genetic resources.
  • (2) Providers and users of genetic resources should be cognizant of the importance of genetic resources and affirmatively support the State’s policy of protection and managing Genetic Resources.

Article 5 (Relationship with other Acts)

Except as otherwise provided for in any other Act, the access to and utilization of genetic resources and benefit sharing shall be governed by the provisions of this Act.

Article 6 (Establishment of Support Measures)

In order to support access and use of genetic resources, the State shall provide the following measures.

  • 1. Providing current status on the research of access and utilization of genetic resources.
  • 2. Providing domestic and foreign information regarding access to genetic resources and benefit sharing procedures.
  • 3. Protecting the rights to those who utilize and access genetic resources.
  • 4. Providing other supports to those who access or utilize genetic resources.

Chapter 2. Access and Utilization and Benefit Sharing of Domestic Genetic Resources

Article 7 (National Focal Point)

  • (1) In accordance with Article 13 (1) of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising From Their Utilization to the Convention on Biological Diversity (the “Protocol”), the national focal point (hereinafter, “National Focal Point”) and its services are as follows:
    • 1. Ministry of Foreign Affairs: Liaising with the secretariat of the Convention on Biodiversity.
    • 2. Ministry of Environment: Dissemination of information on access to genetic resources and sharing of benefits.
  • (2) The scope of the information provided pursuant to Paragraph 1 above, and matters concerning the duties of the National Focal Point shall be prescribed by Presidential Decree.

Article 8 (Competent National Authorities)

  • (1) In accordance with Article 13 (2) of the Protocol, the competent national authorities (hereafter the “Competent National Authorities”) and its field of jurisdiction are as follows:
    • 1. Ministry of Science, ICT and Future Planning: Bio-resources in accordance with the Act on the Acquisition, Management, and Utilization of Bio-resources for Research.
    • 2. Ministry of Agriculture, Food and Rural Affairs: Agricultural Bio-resources in accordance with the Act on the Preservation, Management, and Use of Agricultural Bio-resources.
    • 3. Ministry of Health and Welfare: Pathogenic organism resources in accordance with the Act on the Collection, Management, and Utilization of Pathogenic organism Resources.
    • 4. Ministry of Environment: Biological resources sector in accordance with the Act on the Wildlife Conservation and Management and in accordance with the Act on Biodiversity Convention and Utilization.
    • 5. Ministry of Oceans and Fisheries: Marine bio-resources in accordance with the Act on the Acquisition, Management, and Utilization of Marine Bio-resources.
  • (2) In order to carry out the duties as prescribed in Paragraph1 above, the head of the Competent National Authority shall perform the following duties:
    • 1. Reporting in accordance with Article 9 below and processing any changes in the reporting.
    • 2. Prohibiting or restricting access and utilization of domestic genetic resources in accordance with Article 12(1) below.
    • 3. Supporting the fair and equitable sharing of benefits from domestic genetic resources.
    • 4. Other necessary matters relating to access and utilization of domestic genetic resources shall be prescribed by Presidential Decree.

Article 9 (Reporting of Access to Domestic Genetic Resources)

  • (1) Where foreigners, overseas Koreans, foreign institutions, and international organizations and those individuals designated by an ordinance of the Ministry of Environment seek to access and utilize domestic genetic resources, shall report to the head of the Competent National Authority in accordance with a Presidential Decree.
  • (2) Notwithstanding Paragraph 1 above, if the procedures under the following subparagraphs have been complied with, it will be deemed that that a reporting has been done in accordance with Paragraph 1 above.
    • 1. Cases where approval was granted in accordance with Article 11(2) of the Act on the Conservation and Utilization of Biological Diversity or if reporting was done in accordance with Article 13(1) of the same Act on the Conservation and Utilization of Biological Diversity.
    • 2. Cases where approval was granted in accordance with Article 18(1) of the Act on the Preservation, Management, and Use of Agricultural Bio-resources.
    • 3. Cases where permission was granted under Article 11(1) of the Act on the Acquisition, Management, and Utilization of Marine Bio-resources or if approval was received in accordance with Article 22(1) of the same Act on the Acquisition, Management, and Utilization of Marine Bio-resources.
    • 4. Cases where approval or permission was granted under Article 16(1) or Article 18(1) of the Act on the Collection, Management, and Utilization of Pathogen Resources or if reporting was done in accordance with Article 16(2) of the same Act on the Collection, Management, and Utilization of Pathogen Resources.
  • (3) If a person who has reported in accordance with Paragraph 1 above seeks to change matters prescribed by Presidential Decree, then that person shall report the change to the head of the Competent National Authority.
  • (4) For the purposes of utilization domestic genetic resources, if a Korean national is required to verify that the provider of the genetic resource is the Republic of Korea (as a country that provides the genetic resources as a country of origin or refers to a country that has legally acquired in accordance with the Convention on Biological Diversity. Hereinafter the same shall apply), the Korean national can, if proscribed by Presidential Decree, report to the head of the Competent National Authority pursuant to Paragraph 1 and Paragraph 3.

[Enforcement TBD] One year after the date on which the Protocol becomes effective in Korea.

Article 10 (Exceptions to Reporting of Access to Domestic Genetic Resources.)

Notwithstanding Article 1(9), if any of the following are applicable, the head of the Competent National Authority, in accordance with the Presidential Decree, in consultation with the head of the relevant central administrative agency seek to simplify the genetic resources access reporting procedures or waive the reporting requirement.

  • 1. If it is recognized that expedited access or use of the genetic resources is required for the development of therapeutic drugs and food security in the event there are threats to the life and health of humans, animals, and plants.
  • 2. In the case where access to genetic resources for non-commercial purposes such as pure research; however, if the non-commercial purpose changed, it should be reported without delay in accordance with Article 9(1).

[Enforcement TBD] One year after the date on which the Protocol becomes effective in Korea.

Article 11 (Sharing the Benefits of Domestic Genetic Resources)

Providers and users of genetic resources should agree to share the benefits of domestic genetic resources fairly and equitably.
[Enforcement TBD] One year after the date on which the Protocol becomes effective in Korea

Article 12 (Prohibition Against Certain Access and Utilization of Domestic Genetic Resources)

  • (1) If any of the following are applicable, the head of the Competent National Authority, in consultation with the head of the relevant central administrative agency seek to prohibit or restrict the access and use of the domestic genetic resources.
    • 1. When it is recognized that there is a risk of causing harm or to cause harm to the preservation and continuous use of biodiversity (hereinafter, “Biodiversity”) in accordance with Article 2(1) of the Act on the Conversation and Use of Biodiversity.
    • 2. When it is recognized that there is a negative impact socio-economically or the possibility to have a negative impact socio-economically on the value of biodiversity.
  • (2) If pursuant to Paragraph 1, the head of the Competent National Authority seeks to prohibit or restrict the access and use of Genetic Resources, then the head of the Competent National Authority must notify the prohibited or restricted contents of the applicable Genetic Resource.

Chapter 3. Access and Utilization of Foreign Genetic Resources and Benefit Sharing

Article 13 (National Checkpoints)

  • (1) Subject to Article 17 of the Protocol, the national checkpoint (hereinafter, “National Checkpoint”) and its field of jurisdiction are as follows:
    • 1. Ministry of Science, ICT and Future Planning: Ministry of Science, ICT and Future Planning: In accordance with the Act on the Acquisition, Management, and Utilization of Bio-resources for Research.
    • 2. Ministry of Agriculture, Food and Rural Affairs: Agricultural Bio-resources in accordance with the Act on the Preservation, Management, and Use of Agricultural Bio-resources.
    • 3. Ministry of Trade, Industry and Energy: In accordance with the Act on the Acquisition, Management, and Utilization of Bio-resources for Research.
    • 4. Ministry of Health and Welfare: Pathogenic organism resources in accordance with the Act on the Collection, Management, and Utilization of Pathogenic organism Resources.
    • 5. Ministry of Environment: Biological resources sector in accordance with the Act on the Wildlife Conservation and Management and in accordance with the Act on Biodiversity Convention and Utilization.
    • 6. Ministry of Oceans and Fisheries: Marine Bio-resources in accordance with the Act on the Acquisition, Management, and Utilization of Marine Bio-resources.
  • (2) In accordance with Paragraph (1), the head of the National Checkpoint shall perform the following tasks will be undertaken.
    • 1. Procedural compliance regarding handling of report in accordance with Article 15.
    • 2. Procedural compliance regarding investigations and recommendations.
    • 3. Support to persons who uses foreign genetic resources domestically.
    • 4. Other necessary matters relating to access and use of foreign genetic resources as prescribed by Presidential Decree.

Article 14 (Compliance with Procedures regarding Access and Use of Foreign Genetic Resources)

  • (1) Any person who wishes to access the overseas genetic resources for use in Korea shall observe the procedures established by the providing country.
  • (2) Any person who wishes to access foreign genetic resources for use in Korea shall endeavor to fairly and equitably share the benefits of the overseas genetic resources with the providers of the applicable genetic resources.

Article 15 (Procedural Compliance Reporting)

  • (1) A person who intends to access foreign genetic resources for use to use in Korea shall report to the head of the National Checkpoint as prescribed by the Presidential Decree that the person has complied with the procedures set forth in Article 14(1).
  • (2) The report referred to in Paragraph 1 is limited to cases where it is used in Korea by accessing the genetic resources of the provider country which has established procedures for accessing and using genetic resources as a country that is a party to the Protocol.

[Enforcement TBD] One year after the date on which the Protocol becomes effective in Korea.

Article 16 (Procedural Compliance Investigation)

  • (1) In any of the following cases, the head of the National Checkpoint may investigate whether a domestic user of foreign genetic resources has complied with the procedures set for in Article 14(1).
    • 1. In the case where there is an objection to the procedural violations under Article 14(1) from the providing country.
    • 2. In the case where a third party has provided information regarding procedural violations under Article 14(1).
    • 3. In the case where is considerable reasons to be suspicious that procedures were not observed under Article 14(1).
  • (2) In the case where the results of the investigations are required under Paragraph 1, the head of the National Checkpoint may recommend that a person using foreign genetic resources domestically observe the procedures in accordance with Article 14(1).
  • (3) A person using foreign genetic resources domestically shall cooperate with investigations under Paragraph 1.
  • (4) The details and methods of investigation under Paragraph 1 shall be determined by Presidential Decree.

[Enforcement TBD] One year after the date on which the Protocol becomes effective in Korea.

Chapter 4. Supplementary Rules

Article 17 (Genetic Resources Information Management Center)

  • (1) The Minister of Environment shall establish and operate an information management center (hereinafter, “Genetic Resources Information Management Center”) in order to expertly carryout the task related to access and use of genetic resources and benefit sharing.
  • (2) The Genetic Resources Information Management Center shall perform following tasks:
    • 1. Collecting, managing, investigating, and providing information related to foreign and domestic access and use of genetic resources and benefit sharing.
    • 2. Providing information on access and benefit sharing clearing house in accordance with Article 14 of the Protocol for domestic genetic resources.
    • 3. Other necessary matters relating to the tasks of National Focal Point, Competent National Authorities, and National Checkpoints as prescribed by Presidential Decree.
  • (3) The heads of Competent National Authorities and National Checkpoints shall provide the following information regarding access to genetic resources and benefit sharing to the Genetic Resources Information Management Center
    • 1. Matters concerning reporting or change reporting under Article 9.
    • 2. Matters concerning reporting under Article 15 and investigation and recommendations under Article 16.
    • 3. Other matters prescribed by Presidential Decree.
  • (4) Matters necessary for the establishment and operation of the Genetic Resources Information Management Center shall be determined by Presidential Decree.

Article 18 (Composition and Operation of the Council)

  • (1) The Minister of Environment may establish and operate the Council to consult with the head of the relevant central administrative agency regarding necessary matters for the access and use of genetic resources and for benefit sharing.
  • (2) The composition and operations of the Council in accordance with Paragraph 1 and other matters shall be determined by Presidential Decree.

Article 19 (Information Protection)

  • (1) The heads of the National Focal Point, Competent National Authorities, National Checkpoints and Genetic Resources Information Management Center shall take all measures necessary to protect genetic resources information in order to protect the rights of the providers and users of genetic resources.
  • (2) The respective heads of agencies and the Center under Paragraph 1, shall not use information related to genetic resources for commercial purposes or provide them to other persons except as prescribed by Presidential Decree.

Article 20 (National Subsidy)

The State may subsidize all or part of the costs to an agency, corporation, or organization carrying out projects that promote access and use of genetic resources and benefit sharing.

Article 21 (Securing Financing)

The State should prepare measures to secure funding to promote access and use of genetic resources and benefit sharing.

Article 22 (Fees)

  • (1) Pursuant to Article (1) (3) and (4), any person intending to report or change a report shall pay a fee.
  • (2) The amount of the fee as referenced in Paragraph 1, payment method, and payment period shall be determined by an ordinance of the Ministry of Environment

[Enforcement TBD] One year after the date on which the Protocol becomes effective in Korea.

Article 23 (Delegation and Entrustment of Authority)

  • (1) Part of the authority of the Competent National Authority and National Checkpoint under this Act may be delegated to the heads of their respective agencies or entrusted to other administrative agency heads, as prescribed by Presidential Decree.
  • (2) Part of the duties of the Competent National Authority and National Checkpoint under this Act may be entrusted to the heads of related specialized institutions, corporations or organization as prescribed by Presidential Decree

Article 24 (Deemed Public Officials for Purposes of Penalty Provisions)

Any executives or employees of related specialized agencies, corporations or organizations conducting business affairs entrusted pursuant to Article 23(2) shall be deemed a “public official” for the purposes of penal provisions under Articles 129 through 132 of the Criminal Act.

Article 25 (Review of Regulations)

Regarding the following matters, the Minister of Environment shall in every two years based on the reference date (refers to the same day as the reference day every two years), conduct a feasibility study and take measures for improvement.

  • 1. Reporting of domestic access to genetic resources under Article 9(1): One year after the date on which the Protocol becomes effective in Korea.
  • 2. Prohibition or restriction on access and use of domestic genetic resources under Article 12: The date on which the Protocol takes effect in Korea.
  • 3. A report on the procedural compliance under Article 15 and investigation and recommendation on procedural compliance under Article 16: One year after the date on which the Protocol becomes effective in Korea.
  • 4. Administrative fines under Article 28: One year after the date on which the Protocol becomes effective in Korea.

Chapter 5. Penal Provisions

Article 26 (Penal Provisions)

Any person who accesses or uses genetic resources that are prohibited or restricted from access or use in violation of Article 12(1) shall be punished by imprisonment for not more than 3 years or a fine not to exceed 30 Million Won.

Article 27 (Confiscation and Collection)

In case of Article 26, the applicable genetic resource will be confiscated; however, if confiscation is not possible, then equivalent price thereof shall be collected.

Article 28 (Administrative Fines)

  • (1) Any of the following persons shall be subject to administrative fines not to exceed 10 Million Won.
    • 1. Any person that has not filed a report under Article 9(1).
    • 2. Any person that has not filed a report under Article 15(1).
  • (2) A fine not to exceed 5 Million Won shall be imposed on any person that has not filed a report of change under Article 9(3).
  • (3) The administrative fines referenced in Paragraphs 1 and 2 shall be imposed and collected by the respective heads of the Competent National Authorities or the National Checkpoints as prescribed by Presidential Decree.

[Enforcement TBD] One year after the date on which the Protocol becomes effective in Korea.

Addenda <1533, 2017.1.17>

Article 1 (Enforcement Date)

This Act shall enter into force on the date which the Protocol becomes effective in Korea; however, Articles 9 through 11, Article 15, Article 16, Article 22, and Article 28 shall enter into force one year after the date on which the Protocol becomes effective in Korea.

Article 2 (Applicability)

  • (1) Article 12 and Article 14 shall be applicable to any persons who approach for the purposes of using genetic with a resources after the enforcement of this Act.
  • (2) Articles 9 through 11, Article 15 and Article 16 shall be applicable to any persons who approach for the purposes of using genetic resources after the effective date of the same provision.

Article 3 (Interim Measures in Accordance with the Implementation of the Act on the Preservation, Management, and Use of Agricultural Bio-resources and Act on the Acquisition, Management, and Utilization of Marine Bio-resources)

  • (1) Act on the Preservation, Management, and Use of Agricultural Bio-resources in the Article 8(1)2
Enforcement Decree of the Act on Access and Utilization of Genetic Resources
and the Sharing of Benefits

Article 1 (Purpose)

The purpose of this Decree is to prescribe matters delegated by the Act on Access and Utilization of Genetic Resources and Benefit Sharing and to regulate the implementation details.

Article 2 (Scope of Information Provided by Competent National Authorities)

The definitions of terms used in this Act shall be as follows:

  • (1) The Minister of Foreign Affairs in order to carry out business under Article 7(1) (1) of the Act on Access and Utilization of Genetic Resources and the Sharing of Benefits (hereinafter “Act”) shall as the head of Competent National Authorities, provide below listed information with the secretariat (the “Secretariat”) of the Nagoya Protocol.
    • 1. Information related to designation and changes to the National Focal Point, Competent National Authorities and/or National Inspection Agencies.
    • 2. Information on the division of responsibilities between National Focal Point or National Inspection Agencies.
    • 3. Any Information requested from the Secretariat pursuant to NAGOYA PROTOCOL ON ACCESS TO GENETIC RESOURCES AND THE FAIR AND EQUITABLE SHARING OF BENEFITS ARISING FROM THEIR UTILIZATION TO THE CONVENTION ON BIOLOGICAL DIVERSITY (the “Protocol”).
  • (2) The Minister of the Environment in order to carry out business under Article 7(1)(2) of the Act, shall, as the head of the Competent National Authorities, provide to any person who intends to access the domestic genetic resources and related traditional knowledge ("genetic resources") the below listed information.
    • 1. Matters concerning National Focal Point and their genetic resources.
    • 2. Matter concerning the reporting of access to domestic genetic resources under Article 9 of the Act.
    • 3. Exceptions to the reporting of access to domestic genetic resources under Article 10 of the Act.
    • 4. Sharing of profits arising from the use of domestic genetic resources under Article 11 of the Act.
    • 5. Restrictions or prohibitions on access to and use of domestic genetic resources under Article 12 of the Act.
    • 6. Other matters related to access and sharing of profits regarding domestic genetic resources.
  • (3) The Minister of Foreign Affairs and the Minister of the Environment in order to carry out its dues under Article 7(1) of the Act, may request information from respective heads of the National Focal Point or other relevant agencies. In the case where request for information is made, the heads of the National Focal Point or other relevant agencies shall comply with such requests, unless there is special reasons for non-compliance.
  • (4) The Minister of Foreign Affairs and the Minister of Environment shall share the data submitted in accordance with paragraph (3) and endeavor to cooperate with each other in order to facilitate seamless work performance.

Article 3 (Duties of National Focal Point)

The term "matters prescribed by the Presidential Decree" in Article 8 (2) (4) of the Act shall mean the following:

  • 1. Investigation and management of utilization status of genetic resources, etc. for each of the below listed clauses.
    • (a). Reporting of genetic resources in accordance with Article 9 of the Act (including genetic resources that are deemed to have been reported pursuant to paragraph 2 of the same Article).
    • (b). Genetic resources suspected of violating the reporting duty under Article 9 of the Act.
    • (c) Genetic resources that have been granted an exception to the reporting obligation in accordance with Article 10 of the Act.
    • (d). Genetic resources which the use or access is prohibited or limited pursuant to Article 12 of the Act.
  • 2. Investigation and management of the conclusion of the agreement on profit sharing pursuant to Article 11 ("mutual agreement conditions") and the implementation status thereof.

Article 4 (Reporting of Access to Domestic Genetic Resources)

  • (1) Foreign nationals, overseas Koreans, foreign institutions, international organizations and others (as approved by an Ordinance of the Ministry of the Environment) who wish to access the use of domestic genetic resources pursuant to Article 9(1) of the Act, (collectively, "Foreigners.") is required to submit documentary evidence for each of the below requirements to the head of the National Focal Point before accessing the relevant genetic resource
    • 1. The name and affiliation of the applicant (in the case of a corporation, the corporate name and the representative director), address (in the case of a corporation, its registered address), identification number (date of birth, alien registration number, business registration number, etc.) and contact number.
    • 2. Name of the genetic resource to be accessed (common name and scientific name of the species concerned), quantity or concentration.
    • 3. Purpose for use of the genetic resources (including information on third parties if genetic resources are provided through third parties contracts, etc.), period of use.
    • 4. The name and affiliation of the person providing the genetic resource (in the case of a corporation its corporate name and the name of the representative director), address (in the case of a corporation, its registered address), identification number (date of birth, alien registration number, business registration number), contact number.
    • 5. Purpose for using the applicable genetic resources concerned.
    • 6. The applicable Biotechnology that will be utilized and applied to the genetic resources.
    • 7. Countries seeking to use the applicable genetic resources.
    • 8. Whether or not the terms of the mutual agreement condition for the relevant genetic resources is concluded or not and, its terms.
  • (2) The head of the National Focal Point shall notify the applicant of the acceptance of the application within 30 days from the date of receipt of the notification under paragraph 1and issue a certificate of completion; provided, however, if any of the below information is missing, the head of the National Focal Point may ask, without delay and as appropriate, for supplementary submissions.
    • 1. If the description on the notification form has a flaw.
    • 2. If the evidentiary documents are not attached or insufficient.
    • 3. If veracity of the information provided cannot be proven.
  • (3) If any of the below provisions are applicable, the head of the National Focal Point, the head of the National Focal Point can reject and return the application and provide the reason for the rejection. However, in the case of 2, the necessary procedures for approval, permission, and notification shall be communicated together.
    • 1. If the applicant has not provided supplementary submissions within the period prescribed in Paragraph 2.
    • 2. Where permission, approval or notification under the provisions of Article 9 (2) of the Act is required.
    • 3. In the case of accessing genetic resources that are prohibited or restricted in accordance with Article 12 of the Act.
  • (4) The Head of the National Focal Point shall be deemed to have accepted the notification on the day following the end of the period unless it has notified the applicant of the completion of the notification or extension of the period of treatment within the period set forth in Paragraph (2).
  • (5) If a Foreigner who has been issued a notification certificate pursuant to Paragraph 2 concludes a mutual agreement afterward the issuance of notification certificate, the Foreign applicant may submit the supporting document and request for confirmation to the head of the National Focal Point and receive the confirmation.
  • (6) The form and supporting documents of the notification under paragraph (1), the form of the notification certificate in accordance with paragraph (2), the confirmation application and verification certificate in accordance with paragraph (5), and other necessary matters shall be determined by an Ordinance of the Ministry of the Environment.

Article 5 (Notification of Changes to Domestic Genetic Resources)

  • (1) In Article 9(3) of the Act, The term "prescribed by Presidential Decree" means a case falling under any of the following subparagraphs:
    • 1. Purpose of accessing the applicable genetic resource.
    • 2. An increase of not less than 10% of the declared genetic resource content or concentration (except for microorganisms).
    • 3. Changes to the terms of the mutual agreement.
  • (2) Regarding the notification of change, the provisions of paragraphs (2) to (5) of Article 4 shall apply mutatis mutandis, and the form of the change notification form, certificate of change notification, and other necessary matters shall be determined by an Ordinance of the Ministry of Environment,

Article 6 (Notification by Korean Nationals for Access domestic genetic resources)

  • (1) In Article 4 (4) of the Act, The term "prescribed by Presidential Decree" means a case falling under any of the following subparagraphs:
    • 1. Where it is necessary to confirm that a genetic resource has been legally accessed at the request of another country or a third party.
    • 2. When it is necessary before the enforcement of the Act to confirm that the providing country of the accessed genetic resource is the Republic of Korea and to protect is rights as the case may be.
  • (2) Article 4 shall apply mutatis mutandis to the notification of nationality pursuant to Article 9 (4) of the Act, and Article 5 shall apply mutatis mutandis, as it relates to notification change..

Article 7 (Exceptions to Notification of Access to Domestic Genetic Resources)

  • (1) The head of the National Focal Point seeking to simplify access reporting or waiving the reporting requirement under Article 10 of the Act is required to take part in the deliberations by the council pursuant to Article 18 (1) of the Act.
  • (2) The head of National Focal Point shall officially notify, without delay, if it has decided not to simplify the access reporting procedure as a result of deliberation pursuant to 18 (1) of the Act.

Article 8 (Notification of Compliance with Procedures for Foreign Genetic Resources)

  • (1) An applicant who intends to report in accordance with Article 15, Paragraph (1) of the Act is required to submit the necessary forms and supporting evidence to National Inspection Agency within 90 days from the receipt of the prior notification approval from the applicable providing country.
    • 1. The name and affiliation of the applicant (in the case of a corporation the name and the name of the representative director), address (in the case of a corporation, of the registered address of the business), identification number (date of birth, alien registration number, business registration number, etc.).
    • 2. Name of provider country.
    • 3. Name and address of provider
    • 4. Issuer of the prior notification approval, issue date, issuance number.
    • 5. Name of the genetic resource for which the prior notification has been approved (common name and scientific name of the species concerned), quantity or concentration.
    • 6. Purpose and use of genetic resources approved by prior notification.
    • 7. Whether or not the terms of the mutual agreement condition for the relevant genetic resources is concluded or not and, its terms.
  • (2) The head of the National Inspection Agency shall notify the applicant of acceptance within 15 days from the date of receipt of the notification under Paragraph (1) and issue the declaration certificate; provided, however, if any of the below information is missing, the head of the National Inspection Agency may ask, without delay and as appropriate, for supplementary submissions.
    • 1. If the description on the notification form has a flaw.
    • 2. If the evidentiary documents are not attached.
    • 3. If veracity of the information provided cannot be proven.
  • (3) If the head of the National Inspection Agency does not provide to the applicant the status of the application or an extension of time in accordance with time limit proscribed in (2), then the application shall be deemed to effective on the following day of the expiration of the term.
  • (4) The form of the application in (1) and certificate of completion Details concerning the form of the application in paragraph (1) and the details of the certificate of completion in paragraph (2) and other required matters shall be determined by an Ordinance of the Ministry of the Environment.

Article 9 (Integrated Reporting System)

In order to achieve effective management and electronic management, the Minister of the Environment shall, pursuant to notifications and change in accordance with Article 4, notification of change in accordance with Article 5, and reporting procedural compliance pursuant to Article 8, after consultation with the heads of the National Focal Point and National Inspection Agency can establish a joint reporting system that can be jointly established and operated within the genetic resource information sharing system pursuant to Article 11 (1).

Article 10 (Investigation of Procedural Compliance, etc.)

  • (1) The head of the National Inspection Agency shall submit the report or data necessary for the person who uses the foreign genetic resources in Korea to investigate whether the person has complied with the procedure pursuant to Article 14 (1) of the Act or to allow the relevant public official to enter the facility and inspect the premises. However, when the head of the National Inspection Body, which is not the head of the National Focal Point, investigates whether the procedure is complied with,
  • (2) In order to determine whether procedural compliance was followed in accordance with Article 10 of the Act, the head of the National Inspection Agency may ask the user of the foreign genetic resource to submit a report or documentation or may audit the relevant facility with an aid of a Public Official. However, if the head of the National Inspection Agency, not the National Focal Point is conducting the procedural compliance audit, then the National Inspection Agency head must consult with the head of the National Focal Point in advance.
  • (2) If the head of the National Inspection Agency is conducting a location audit, a 7 days prior notice has to be provided to the person using the foreign genetic resources in Korea 7 in accordance with Paragraph 1 above.
  • (3) Public officials who enter and inspect facilities in accordance with Paragraph (1) shall have an official order indicating their authority and must produce it to the persons concerned.
  • (4) Matters concerning official order referenced Paragraph (3) shall be determined by an Ordinance of the Ministry of the Environment.

Article 11 (Establishment and Operation of the Genetic Resource Information Management Center)

  • (1) The Genetic Resource Information Management Center shall share information for the purpose of sharing the benefits arising from the access and use of genetic resources for the purpose of carrying out the tasks pursuant to Article 17 (2) (“Genetic Resource Information Sharing System").
  • (2) The head of the Information Resource Management Center may, if necessary, request the head of the Competent National Authority to provide relevant information. If the head of Competent National Authority does not have such information, then the head of the Information Resources Management Center may reach out to the heads of the National Focal Point and the National Inspection Agency, or other administrative bodies and request relevant information. In such an event, the respective heads that have received such request shall comply, unless there is a special reason not to comply.
  • (3) With prior approval from the Minister of Environment, in order to carry out its work, the head of the Information Resource Management Center may request the dispatch of the civil servant or staff to the head of the relevant administrative agency.
  • (4) The head of the Genetic Resources Information Management Center shall, pursuant to Article 11 of the Act on the Acquisition, Management, and Utilization of Bio-resources for Research link the Genetic Resource Information Sharing System to the Korean Bio-information Center if designated.be the National Livestock Resource Information Center The genetic information sharing system should be linked to each other

Article 12 (Duties of the Genetic Resource Information Management Center)

The term "matters prescribed by the Presidential Decree" in Article 17 (2) (3) of the Act means the following items.

  • 1. Provide support to Competent National Authorities, National Focal Point, and National Inspection Agencies.
  • 2. Establishment of Genetic Resource Information Sharing System.
  • 3. International cooperation and information exchange with foreign genetic resource information management organizations.
  • 4. Interaction with providers and users of genetic resources and raising awareness.

Article 13 (Information provided to the Center for the Management of Genetic Resources)

Pursuant to Article 17 (3) of the Act, the term "matters prescribed by the Presidential Decree" in the preceding paragraph means the following matters:

  • 1. Matters concerning access to or use of domestic genetic resources and matters related to profited use or access under Article 12 of the Act.
  • 12. The information protection measures pursuant to Article 19 (1) of the Act.
  • 13. Matters concerning the confirmation of mutual agreement under Article 4 (5).
  • 14. Other matters necessary for the implementation of the Protocol as a contracting party the Protocol.

Article 14 (Composition and Operation of the Council)

  • (1) The council pursuant to Article 18 (1) of the Act (the "Council") shall consist of not more than 20 members, including one chairperson.
  • (2) The Chairperson of the Council shall be the deputy minister of the Ministry of Environment, and the members shall be comprised of persons who fall under any of the following subparagraphs, but in the case of subparagraph 2, the gender shall be considered.
    • 1. One senior official from each of the administrative agencies, including, but not limited to the Ministry of Science, ICT and Future Planning, Ministry Foreign Affairs, Ministry of Agriculture, Food and Rural Affairs, Ministry of Trade, Industry and Energy, Ministry of Health and Welfare, Ministry of Oceans and Fisheries as selected by the head of from the central government.
    • 2. A person who has extensive knowledge and experience with the Nagoya Protocol who is nominated by the head of the relevant central administrative agency and appointed by the Minister of the Environment.
  • (3) The Council shall deliberate on the following matters.
    • 1. If the authority between National Focal Point and National Inspection Agency is unclear.
    • 2. Exceptions to access reports under Article 10 of the Act.
    • 3. Prohibition or restriction to access and use under Article 12 of the Act.
    • 4. Any other matter to be examined by the heads of the National Competent Authorities, the National Focal Point, and the National Inspection Agency for the implementation of the Nagoya Protocol.
  • (4) One administrative assistant shall be assigned to the council to handle the business affairs, and the chairperson among the civil servants belonging to the Ministry of Environment shall appoint the administrative assistant.
  • (5) The working council may be established in the council for review of matters delegated by the council.
  • (6) The Council may operate in conjunction with the National Biodiversity Commission under Article 2 of the Enforcement Decree of the Act on the Protection and Utilization of Biodiversity.
  • (7) Details concerning the composition and operation of the council and working council shall be determined by the Ordinance of the Ministry of the Environment.

Article 15 (Protection of Information)

In Article 19 (2) of the Act, the term "prescribed by Presidential Decree" means any of the following cases:

  • 1. In the case that the applicable provider and user of the genetic resources agree in writing
  • 2. Disclosure for statistical, academic research or market research, where any specific identifying genetic markers and related persons are redacted.
  • 3. Generally accepted techniques for using genetic resources
  • 4. Methods and plans of measures necessary for the protection of information pursuant to Article 19 (1) of the Act.

Article 16 (Authorization and Delegation of Authority)

  • (1) The Minister of Health and Welfare delegates the following powers to the head of the Disease Control Division in accordance with Article 23 (1) of the Act.
    • 1. Authority over the following items as the head of the National Focal Point
      • (a) Processing of access report or change report under Article 9 of the Act.
      • (b) Prohibition or restriction of access and use under Article 12 of the Act.
      • (c) Investigation and management of the use of genetic resources under Article 3(1)
    • 2. Authority over the following items as the head of the National Inspection Agency
      • (a) Procedural compliance with procedures under Article 15 of the Act.
      • (b) Investigation of compliance with procedures under Article 16 of the Act.
  • (2) The Minister of Ministry of Agriculture, Food and Rural Affairs shall delegate the powers of the following subparagraphs in accordance with Article 23 Paragraph (1) of the Act to the responsible authority designated pursuant to Article 14. (1) of the Act on the Preservation, Management, and Use of Agricultural Bio-resources
    • 1. Authority over the following items as the head of the National Focal Point
      • (a) Support for the fair and equitable sharing of profits of domestic genetic resources under Article 8 (2) 3 of the Act.
      • (b) Processing of access report or change report under Article 9 of the Act.
      • (c) Prohibition or restriction of access and use under Article 12 of the Act.
      • (d) Imposition and collection of penalties pursuant to Article 28 of the Act.
    • 2. Authority over the following items as the head of the National Inspection Authority
      • (a) Support to those using domestic genetic resources in Korea under Article 13 (2) 3 of the Act.
      • (b) Procedural compliance with procedures under Article 15 of the Act.
      • (c) Investigation of compliance with procedures under Article 16 of the Act.
      • (d) Imposition and collection of penalties pursuant to Article 28 of the Act.
  • (3) The Minister of Environment delegates the authority of the following subparagraphs to the head of the Genetic Resources Information Management Center pursuant to Article 23 (1) of the Act.
    • 1. Authority over the following items as the head of the National Focal Point
      • (a) Support for the fair and equitable sharing of the profits of domestic genetic resources under Article 8 (2) 3 of the Act.
      • (b) Processing of access report or change report under Article 9 of the Act.
      • (c) Imposition and collection of penalties pursuant to Article 28 of the Act
      • (d) Investigation and management of status of use of genetic resources under each subparagraph in Article 3 and investigation and management of mutual agreements.
    • 2. Authority over the following items as the head of the National Inspection Authority
      • (a) Support to those using foreign genetic resources in Korea under Article 13(2)(3) of the Act.
      • (b) Procedural compliance with procedures under Article 15 of the Act.
      • (c) Investigation of compliance with procedures under Article 16 of the Act.
      • (d) Imposition and collection of penalties pursuant to Article 28 of the Act.

Article 17 (Delegation of duties)

Ministry of Science, ICT and Future Planning: In accordance with the Act on the Acquisition, Management, and Utilization of Bio-resources for Research.

  • (1) The Minister of Science, ICT and Future Planning, in accordance with Article 23 (2) of the Act, delegates the following duties specified in Article 10 (1) of the Act on the Acquisition, Management, and Utilization of Bio-resources for Research appointed focal points.
    • 1. Authority over the following items as the head of the National Focal Point
      • (a) Notification of registration or registration change acceptance and notification of acceptance in accordance with Article 9 of the Act.
      • (b) Support for the fair and equitable sharing of the profits of domestic genetic resources under Article 8 (2) 3 of the Act.
      • (c) Investigation and management of the status of use of genetic resources under Article 3 and investigation and management of mutual agreement.
    • 2. Authority over the following items as the head of the National Investigation Agency
      • (a) Receipt of notification under Article 15 of the Act.
      • (b) Procedural compliance investigation in accordance with Article 16 of the Act.
      • (c) Dissemination of information provided pursuant to Article 17(3) of the Act.
  • (2) The Minister of the Ministry of Trade, Industry and Energy shall entrust the tasks of the following subparagraphs to the Biosafety Clearing-House under Article 32 of the Act on the Transboundary Movement of Transgenic Living Organisms as the head of the National Inspection Agency.
    • 1. Support to those using foreign genetic resources in Korea under Article 13(2) (3) of the Act.
    • 2. Receipt of notification of compliance with procedures under Article 15(1) of the Act.
  • (3) The Minister of Maritime Affairs and Fisheries shall entrust the National Marine Living Resources Director with the following duties in accordance with Article 23 (2) of the Act:
    • 1. Authority over the following items as the head of the National Focal Point
      • (a) Support for the fair and equitable sharing of the profits of domestic genetic resources under Article 8 (2) 3 of the Act.
      • (b). Investigation and management of the status of use of genetic resources under Article 3 and investigation and management of mutual agreement
    • 2. Support for those who use domestic genetic resources in accordance with Article 13 (2) (3) of the Act as the head of the National Inspection Agency.

Article 18 (Fines for Negligence)

The criterion for administrative fines imposed pursuant to Article 28 of the Act is shown on Table 1 attached hereto.

Supplement

Article 1 (Date of Enforcement)

This Act shall enter into force on the date which the Protocol becomes effective in Korea; however, Articles 4 through 8, Article 10 and Article 18 shall enter into force one year after the date on which the Protocol becomes effective in Korea.

Imposition of Fines

1. General Standard

  • (a) The standard of imposition of penalties according to the number of violations shall be applied in case of penalties for the same violation for the past two years. In this case, the number of violations is counted based on the date of the penalty charge for the offense and the date of the same type of offense.
  • (b) The person who has the right to impose penalties may reduce the penalty amount in the range of one - half of the amount of penalty pursuant to the individual criterion in the second clause in any of the following cases. However, this shall not apply to violators who are in default of penalties
    • 1) If the offender falls under any of the provisions of Article 2-2, Paragraph 1 of the 「Enforcement Decree of the Regulation of the Order Infringement Act」
    • 2) In case that the violator committed the violation for the first time and it is recognized that the violator has been in good standing in the relevant research institute or industry for 3 or more years
    • 3) If there is a serious violation of the business due to the occurrence of significant damage to the property due to natural disasters or force majeure events or deterioration of business conditions
    • 4) If the violation is due to simple negligence or error, not intentional or willful misconduct.
    • 5) If a violator corrects or ceases the violation immediately
    • 6) In cases where it is deemed necessary and proper to reduce the fine for negligence in consideration of the degree of violation, the motivation for the violation, and the outcome.
  • (c) The person who has the right to impose penalties shall take into consideration the degree of the violation, the motive of the violation. The amount may be increased by a margin of one-half of the penalty amount in accordance with the standards. However, even if an increase is imposed, the upper limit of the fine for negligence pursuant to Article 28 (1) and (2) of the Act shall not be exceeded.

2. Individual Criteria

(KRW: )

Individual Criteria
Prohibited Act Applicable Statute Fine Amount
(a) A person that fails to undertake access reporting in violation of Article 9(1) of the Act Article 28(1)(1) of the Act 1st Violation 2nd Violation 3rd Violation
200 400 800
(b) A person that fails to report procedural compliance in accordance with Article 15(1) of the Act Article 28(1)(2) of the Act 1st Violation 2nd Violation 3rd Violation
200 400 800
(c) A person that fails to undertake notification of change in violation of Article 9(3) of the Act Article 28(2) of the Act 1st Violation 2nd Violation 3rd Violation
200 400 800
Enforcement Rule of the Act on Access and
Utilization of Genetic Resources and Sharing of Benefits

Article 1 (Purpose)

The purpose of this Regulation is to prescribe the matters entrusted by the Enforcement Decree of the Act on the Access and Utilization of the Genetic Resources and the Sharing of the Benefits, and the matters necessary for its implementation.

Article 2 (Foreigners)

  • The term "a person prescribed by an Ordinance of the Ministry of Environment" in Article 9 (1) of the Act on Access and Utilization of Genetic Resources and Sharing of Benefits (the "Act") shall apply to any of the following.
    • 1. Corporations established pursuant to foreign law.
    • 2. Corporations established in accordance with the laws of the Republic of Korea which has its headquarters or main office in foreign a foreign country.

Article 3 (Access Reports Notification Forms)

  • (1) The Notification Form pursuant to Article 1 of the Enforcement Decree of the Act on the Access and Utilization of the Genetic Resources and the Sharing of the Benefits (the “Decree”) is attached hereto as Annex No. 1.
  • (2) The declaration certificate pursuant to Article 4 (2) of the Decree is attached hereto as Annex No. 2.
  • (3) The application for confirmation pursuant to Article 4 (5) of the Decree is attached hereto as Annex No. 3.
  • (4) The confirmation certificate in accordance with Article 4 (5) of the Decree is attached hereto as Annex No. 4.

Article 4 (Change Notification Form)

  • ((1) The change notification form pursuant to Article 5 (2) of the Decree is attached hereto as Annex No. 5.
  • (2) The declaration certificate in accordance with Article 5 (2) of the Decree is as attached hereto as Annex No. 6.

Article 5 (Notification Forms For Compliance with Procedures)

  • (1) A declaration pursuant to Article 8 (1) of the Decree is attached hereto as Annex No. 7.
  • (2) The declaration certificate in accordance with Article 8 (2) of the Decree is attached hereto as Annex No. 8.

Article 6 (Identification of Inspection Officials)

The form of the identification card in accordance with Article 4 (4) of the Decree is attached hereto as Attachment No. 9.

Article 7 (Operation of the Council)

  • (1) The chairperson of the council pursuant established pursuant Article 18 (1) of the Act (the "Council") shall represent the council and shall oversee the operations of the Council.
  • (2) When the chairperson is unable to perform the duties for unavoidable reasons, the person appointed by the chairperson in advance shall act on the chairperson’s behalf.
  • (3) A member commissioned pursuant to Article 14 (2) (2) of the Decree shall have a term of two (2) years and may seek reappointed once.
  • (4) A meeting of the Council shall be held at the attendance of a majority of the members of the council and shall be decided by the affirmative vote of a majority of the members present.
  • (5) In addition to the matters provided for in Paragraphs (1) to (4), matters necessary for the operation of the Council shall be determined by the Chairperson after deliberation by the Council.

Article 8 (Composition and Operation of Working Council)

  • (1) The working council pursuant to Article 14 (5) (the "Working Council") shall consist of not more than 20 members, including one chairperson.
  • (2) The Chairperson of the Working Council shall be a person designated by the Minister of Environment among the public officials belonging to the senior civil servants of the Ministry of Environment, and the committee shall be comprised of a person who falls under any of the following subparagraphs, but in the case of subparagraph 2, the gender shall be considered.
    • 1. One senior official achieving a level of 4 or higher from each of the administrative agencies, including, but not limited to the Ministry of Science, ICT and Future Planning, Ministry of Foreign Affairs, Ministry of Agriculture, Food and Rural Affairs, Ministry of Trade, Industry and Energy, Ministry of Health and Welfare, Ministry of Oceans and Fisheries
    • 2. A person who has extensive knowledge and experience with the Nagoya Protocol who is nominated by the head of the relevant central administrative agency and appointed by the Minister of the Environment
  • (3) In addition to the matters stipulated in Paragraphs (1) to (2), matters necessary for the operation of the Working Council shall be determined by the Chairperson after deliberation by the Working Council.

Article 9 (Fees)

  • (1) Fees under Article 22 (1) of the Act shall be as follows.
    • 1. Notification under Article 9 (1) of the Act (including notification under Article 9 (4) of the Act): KRW 10,000
    • 2. Notification of Change under Article 9 (3) of the Act (including notification of change under Article 9 (4) of the Act): KRW 5,000
  • (2) Fees under Paragraph (1) may be paid by way of revenue stamp or electronic funds transfer over information and communication network.

Supplement

Article 1 (Date of Enforcement)

This Regulation shall apply to the “Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising From Their Utilization to the Convention of Biological Diversity” (the "Protocol") on access to genetic resources and the fair and equitable sharing of the benefits arising from its use shall take effect on the same day it takes effect in Korea; however, Articles 3 to 6 and Article 9 shall take effect one year after the date on which the Protocol becomes effective in Korea.

Room No.228, Collection & Research Building, National Institute of Biological Resources, Ministry of Environment
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