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• Q [Culture Collection] [Exchange of Genetic Resources between Domestic and International Gene Banks] A domestic gene bank and an overseas gene bank have agreed to mutually exchange genetic resources they each possess. Are the procedures under the Nagoya Protocol required in this case?
  A

  The Nagoya Protocol defines “utilization,” or “the use of genetic resources,” as “conducting research and development related to the genetic and/or biochemical composition of genetic resources by applying biotechnology.”

  In this case, the exchange of genetic resources between gene banks may not be interpreted as “utilization” of resources. The Nagoya Protocol will apply if any activity is considered to be “utilization”. However, since sending genetic resources held by one gene bank in a country to a gene bank in another country constitutes an outflow of domestic resources to a foreign country, it is necessary to check whether there are no legal issues under the domestic laws of the exporting country.

   Gene banks in Korea do not require “reporting access to domestic genetic resources.”

   Nevertheless, third-party distribution after an exchange of resources should be limited to non-commercial research purposes only. If there is a request for commercial distribution, it is advisable to notify the original depositor of the resource(s) so that a contract is entered into between the two parties, or conditions such as compliance with the ABS procedures of the resource-providing country are specified in the Material Transfer Agreement (MTA), etc.

   For more information or any further inquiries related to this matter, please contact The ABS Help Desk under the Ministry of Science and ICT at 042-879-8333 or visit the ABS Information Portal at www.abs.re.kr for assistance. Thank you.

  
  
• Q [Culture Collection] [Domestic Deposit of Overseas Genetic Resources] When a foreigner or an overseas researcher deposits a new strain of microorganism of their country to a gene bank in Korea, what procedures are required with respect to the Nagoya Protocol?
  A

  The depositor must fulfill legal requirements for export of the respective resources in their own country before depositing to a foreign gene bank. The depositor must also confirm if there are laws and procedures for ABS in the depositor’s country that need to be followed when a gene bank in Korea receives a deposit. If applicable, it is advisable to request the depositor to specify in the letter of deposit, Material Transfer Agreement (MTA), or other relevant documents that the deposit was made after undergoing procedures under the depositor’s domestic laws.

  For more information or any further inquiries related to this matter, please contact The ABS Help Desk under the Ministry of Science and ICT at 042-879-8333 or visit the ABS Information Portal at www.abs.re.kr for assistance. Thank you.

• Q [Culture Collection] [Overseas Deposit of Domestic Genetic Resources] We have isolated new genetic material through research conducted using domestic genetic resources. As a requirement for publishing a research paper on this in a journal, we need to deposit the genetic material to an overseas gene bank. Upon applying for deposit to the overseas gene bank, they have requested documentation to - our compliance with the Nagoya Protocol. What documents do we need to obtain for submission and how?
  A

   In principle, Korean citizens do not need a separate report on access when accessing and utilizing domestic genetic resources. However, where supporting documentation is requested, Korean nationals can also submit a “Report on Access to Domestic Genetic Resources.” 

  The reporting process can be initiated through the online portal of the competent national authority. Once the “Certificate of Reporting Access to Domestic Genetic Resources” is issued in English, a copy can be submitted to the overseas gene bank for deposit.

   Please refer to the System to Report Access to Genetic Resources, Ministry of Science & ICT website (www.abs.re.kr/absch) for detailed reporting procedures and forms. Also note that reporting can be done online as well.

   For more information or any further inquiries related to this matter, please contact The ABS Help Desk under the Ministry of Science and ICT at 042-879-8333 or visit the ABS Information Portal at www.abs.re.kr for assistance. Thank you.

  
  
• Q [Utilization of Plants, Animals and Micro-Organisms] [Applicability Based on Type of Utilization] Would the Nagoya Protocol apply if a research project involves importing “B” microorganism from Country A to compare its characteristics with those of “C” microorganism in Korea?
  A

  The Nagoya Protocol defines “utilization,” or “the use of genetic resources,” as “conducting research and development related to the genetic and/or biochemical composition of genetic resources by applying biotechnology.” 

  In this case, there is a potential for interpretation disputes regarding whether the purpose of accessing foreign genetic resources aligns with the definition of “utilization”. The safest approach would be to contact the national authority responsible for genetic resources in the providing country to obtain an authoritative interpretation.

  For more information or any further inquiries related to this matter, please contact The ABS Help Desk under the Ministry of Science and ICT at 042-879-8333 or visit the ABS Information Portal at www.abs.re.kr for assistance. Thank you.

• Q [Utilization of Plants, Animals and Micro-Organisms] [Matters Related to Patent] During collaborative research, a researcher in Korea received marine microorganisms collected from the territorial waters of Country A from a researcher in Country B. If the researcher in Korea applies for a utility patent through the isolation, purification, synthesis, etc., of active substances derived from these microorganisms, will it fall under the scope of the Nagoya Protocol?
  A

  The Nagoya Protocol is applicable regardless of the route by which the resource was acquired. 

  In this case, since the genetic resources of Country A were ultimately used, the Nagoya Protocol must be applied. If Country A enforces obligations such as prior informed consent (PIC) under ABS laws, the entity responsible for complying with these obligations is the Korean researcher who utilized the genetic resources.

   Please also note that the Nagoya Protocol cannot be applicable to resources acquired from international waters as they are not subject to the sovereignty of any particular country.

   For more information or any further inquiries related to this matter, please contact The ABS Help Desk under the Ministry of Science and ICT at 042-879-8333 or visit the ABS Information Portal at www.abs.re.kr for assistance. Thank you.

  
  
• Q [Utilization of Plants, Animals and Micro-Organisms] [Relationship with Other Laws] While importing a strain from abroad, I submitted a report to the Korea Disease Control and Prevention Agency (KDCA) in accordance with the Act on the Promotion of Collection, Management, and Utilization of Pathogen Resources (“the Pathogen Resources Act”). In this case, do I still need to go through the procedures under the Nagoya Protocol and the Act on Access to and Utilization of Genetic Resources and Benefit-Sharing (“the Genetic Resources Act”) again?
  A

  The Genetic Resources Act, which enforces the Nagoya Protocol in Korea, has different legislative purposes and scopes of application from those of the Pathogen Resources Act. Compliance with one Act does not assume compliance with the other. For example, even if all the procedures under the Pathogen Resources Act have been complied with, if the country providing the genetic resources is a party to the Nagoya Protocol and prior informed consent (PIC) is obtained under ABS laws, it is still necessary to also “Report Procedural Compliance for Foreign Genetic Resources” to the National Checkpoint under Article 15 of the Genetic Resources Act.

   For more information or any further inquiries related to this matter, please contact The ABS Help Desk under the Ministry of Science and ICT at 042-879-8333 or visit the ABS Information Portal at www.abs.re.kr for assistance. Thank you.

• Q [Utilization of Plants, Animals and Micro-Organisms] [Change in Purpose of Accessing Genetic Resources] While studying abroad in Country A, I bought an endemic plant native to Country A for ornamental purposes from a market near my school. After completing my studies and returning home, I did research on the plant and found some useful components. If I want to pursue commercial development using these components, do I need to obtain prior informed consent (PIC) from Country A now?
  A

  Unless a user is “utilizing” a genetic resource, it is not necessary to obtain prior informed consent (PIC) for simple use under the Access and Benefit-Sharing (ABS) framework. However, if the intention is to commercialize the resource through R&D, the purpose of accessing the resource has changed. Therefore, there may be an obligation to obtain PIC. 

  In this case, there may be an obligation to obtain PIC according to the laws of Country A. While the initial purpose at the time of purchase as an ornament was not subject to the Nagoya Protocol, the current purpose of pursuing commercial development has now become subject to the Nagoya Protocol.

  For more information or any further inquiries related to this matter, please contact The ABS Help Desk under the Ministry of Science and ICT at 042-879-8333 or visit the ABS Information Portal at www.abs.re.kr for assistance. Thank you.

• Q [Utilization of Plants, Animals and Micro-Organisms] [Domestic Cultivation Following Seed Import] Is the Nagoya Protocol applicable when applying for a patent for and commercializing genetic material extracted from plants cultivated domestically after importing the seeds from abroad?
  A

  The timing of the seed import should be considered first. If the import occurred after the Nagoya Protocol came into effect (October 12, 2014), there could be potential issues depending on the country providing the genetic resources, even if they were grown domestically. In particular, caution must be exercised when filing for a patent, as some countries make the disclosure of the country of origin for the relevant resources mandatory.

   When importing seeds from abroad, it is important to legally obtain them by complying with approval and contractual procedures under the laws of the respective country, and to secure and retain relevant contracts, certificates, etc. carefully.

   The safest approach is to contact the competent national authority of the country providing the seed, explain the situation, and verify whether there are obligations to comply with under Nagoya Protocol and relevant domestic laws.

   If the country providing the seeds is neither a party to the Nagoya Protocol, nor a country that implements ABS procedures, like the United States, or the country is a party to the Nagoya Protocol but does not have separate ABS procedures, like Japan, then the Nagoya Protocol does not apply.

   For more information or any further inquiries related to this matter, please contact The ABS Help Desk under the Ministry of Science and ICT at 042-879-8333 or visit the ABS Information Portal at www.abs.re.kr for assistance. Thank you.

  
  
• Q [Utilization of Plants, Animals and Micro-Organisms] [Verification of Country of Origin] Tree A is known to originate from Country B. Is there an accredited national agency or international organization that can - this information? Also, Tree A is widely distributed not only in Country B but also in the southern regions of Korea. Does this mean that we can consider Korea also as the country of origin for Tree A?
  A

  Unfortunately, no institution is able to confirm the country of origin for a particular resource. It is often difficult to specify a single country of origin for certain genetic resources, especially plants, due to their distribution characteristics.

   The Convention on Biological Diversity (CBD) defines country of origin of genetic resources as “the country possessing genetic resources in situ.” In addition, the CBD defines country providing genetic resources as “the country supplying genetic resources collected from in-situ sources, including populations of both wild and domesticated species, or taken from ex-situ sources, which may or may not have originated in that country.” According to this definition, Korea could also be considered the country of origin for Tree A.

  However, if there are specific components or characteristics in Tree A grown in Country B that are not present in Tree A grown in Korea, and it is essential to acquire Tree A from Country B to investigate such components or characteristics, then Country B becomes the country providing genetic resources. In this situation, it is necessary to comply with the Nagoya Protocol-related laws and procedures of Country B. 

  In the end, while the country of origin is significant, in practical terms, the country providing the resources holds crucial importance.

   In this case, there should be no issues under the Nagoya Protocol if research and development are conducted using Tree A that is native to Korea. 

   

  For more information or any further inquiries related to this matter, please contact The ABS Help Desk under the Ministry of Science and ICT at 042-879-8333 or visit the ABS Information Portal at www.abs.re.kr for assistance. Thank you.

  
  
• Q [General InformationㆍProcedures] [Entity Responsible for PIC ] The owner of foreign genetic resources, such as the owner of the habitat of genetic resources, has granted permission for the genetic resources to be taken freely without any conditions. In this case, is it still necessary to obtain prior informed consent (PIC) from the government of the country providing the genetic resources?
  A

  The private consent of the owner of the resources and the official approval, or PIC, from the country are two separate matters. Even if you have obtained permission from the owner (individual or corporate), if the legislation of the country providing the genetic resources requires PIC, you must obtain it.

   While the provider of the resources is the recipient of benefit-sharing, only the country (or local government, and in relevant cases, Indigenous Peoples and Local Communities (IPLCs)) are entities that can legally approve PIC.

   For more information or any further inquiries related to this matter, please contact The ABS Help Desk under the Ministry of Science and ICT at 042-879-8333 or visit the ABS Information Portal at www.abs.re.kr for assistance. Thank you.