(A) Study of the international ABS (Access and Benefit-Sharing) regime for genetic resources and national implementation process : ABSCH mechanism and Andean Countries (Bolivia, Colombia, Ecuador, Peru)

Kwon, Sohyun 한국외국어대학교 국제지역대학원 2024 국내박사

The Convention on Biological Diversity (CBD) is an international agreement that recognizes the sovereign rights of the state over biological resources. Recognition of a country’s sovereign rights over biological resources has been the main conception from the beginning of the adoption of the CBD, but substantive discussions of this issue have long continued. In particular, there were active discussions between the parties to achieve the third objective of the CBD, fair and equitable sharing of benefits arising from the use of genetic resources, and as a result, ‘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 (Nagoya Protocol on ABS)’ was adopted. The Nagoya Protocol has been facilitating national implementation of the access and benefit-sharing (ABS) since it came into effect in 2014. The Nagoya Protocol builds on the basic principles of access and benefit-sharing set out in the CBD. The key elements of the ABS framework are based on the grant of Prior Informed Consent (PIC) by a provider to a user and negotiations between both parties to develop Mutually Agreed Terms (MAT) that ensure the fair and equitable benefit-sharing of genetic resources and associated traditional knowledge. This agreement includes, as a prerequisite for access to and use of genetic resources, the sharing of benefits arising from the use of the resources with the provider. Conversely, when countries act as providers of genetic resources, they must provide fair and non-arbitrary rules and procedures for access to genetic resources. The Nagoya Protocol covers genetic resources (GRs) and traditional knowledge (TK) associated with genetic resources, as well as the benefits arising from their utilization. Most countries have agreed on the international regime for ABS as required by the CBD and the Nagoya Protocol. Nevertheless, ABS implementation is not progressing well. This study examines why ABS response and implementation differ at the international, regional, and national levels vertically, and at the dimensions of institutions and related stakeholders in national implementation horizontally in light of the concept of multi-level governance (MLG). In other words, why is there no consensus in the process of forming an international regime and why are there differences at the individual country-region-international levels? In particular, this thesis seeks to analyze the differences and numerous problems among various domestic stakeholders that contribute to the formation of this regime domestically as well. From the perspective of multi-level governance, this study closely observes and analyzes the Nagoya Protocol, which is most relevant to the formation of the ABS system under the current CBD regime, especially at the international level, and then moves to the regional level (i.e., the Andean Regime on ABS, such as Decision 391 as a Common Regime on Access to Genetic Resources). Finally, this study focuses on the domestic governance of the Andean region countries (four countries) selected as the case study subjects through observations of important problems and various obstacles in the process of forming the ABS system in these countries through various analysis variables such as administrative capacity, institutional development, building of information sharing system, enforcing of domestic and international cooperation mechanisms, and related key actors who play a major role in the ABS system, including the central government, local governments, various domestic and foreign companies, research centers, local residents—especially indigenous communities in this region—Non-Governmental Organizations (NGOs), and even biological resources (some countries in the region have recently granted ‘Rights of Nature’ to biological resources). Following these theoretical arguments and background, this study employs four variables for analysis from the author’s perspective, such as: Administrative Governance, Institutional Governance, Data Governance (Information Sharing with Data Forming and Management), and Domestic and International Cooperation Governance to measure the current process of constructing the ABS system in Andean countries. These four variables are a reconstruction from the author’s perspective of the following 10 conditions that the CBD international regime currently requires to be measured to observe the level of participation of ABS member countries: ABS National Focal Point (NFP), Competent National Authority (CNA), Legislative, Administrative, or Policy Measures (MSR), ABS Procedure (PRO), National Model Contractual Clause (NMCC), Internationally Recognized Certificates of Compliance (IRCC), National Websites or Databases (NDB), Checkpoint (CP), Checkpoint Communiqué (CPC), and Interim National Report (NR) on the Implementation of the Nagoya Protocol for supporting the implementation of Nagoya Protocol. From the author’s perspective, the current ABS international regime and its implementation process can also be reclassified again here with the above four variables based on the terms of ‘goverance’, which are considered essential elements for pursuing common interests by encouraging member countries to actively participate in the ABS system. The criteria for selecting target countries in this study are that each be a megadiverse country with common genetic resources due to shared biodiversity hotspots, and that it be the first country to access genetic resources through Decision 391 on the Common Regime on Access to Genetic Resources in 1996 after the adoption of the CBD. These are countries that have established cross-border ABS systems. The overall level of statistical analysis of ABS international implementation is showing slow progress because many countries have not yet uploaded national data in the Access and Benefit-Sharing Clearing-House (ABSCH). Only a few countries have worked on implementation at the institutional and information sharing level (e.g. MSR, IRCC). Some countries are only participating in international implementation in the present situation. Administrative governance depends on government capabilities and collaboration between ministries. NFPs, CNAs, CPs, and NRs are all designated by the government and represent it. The designation of NFP can be shown to be the first step in implementing ABS. With 178 countries registered in NFP, it can be shown that most countries are participating in the beginning stages of ABS implementation, but only some countries have registered CNAs, CPs, and NRs. In some countries, multiple agencies are designated as CNAs and CPs, and if there is no coordination and consultation between agencies, this may lead to delays in the ABS implementation process. In Institutional Governance, MSR has a high number of registrations in India and Latin America countries such as Mexico, Honduras, Peru, and Colombia. In all, 21 countries have uploaded PROs. Thus, the pace of progress in the institutional dimension is too slow. In Data Governance (including Information Sharing), only 5 countries have registered NMCCs and 43 countries have registered 59 NDBs; some countries (Portugal 4, Belgium 3, France 3), have uploaded multiple websites. In the case of NDBs, mainly European countries have been building online platforms. Progress in the dimension of Data Governance (including Information Sharing) is slow. Domestic and International Cooperation Governance is evaluated based on IRCCs and CPCs. The concentration of some countries in IRCCs and CPCs is significant. India’s IRCCs account for more than 70% of the total, and India leads the world in terms of ABS agreements with 3,496 IRCCs, where there is a large gap between India and other countries. Taken overall, there are few commercial agreements and IRCCs related to traditional knowledge regarding genetic resources. Regionally, Latin America has few IRCCs. There are a total of 11 countries that have uploaded CPCs, with multiple CPCs from each. A few countries are thus leading in domestic and international cooperation. The overall level of statistical analysis of the national implementation of ABS in Andean countries also shows slow progress because many countries have not yet uploaded national data to ABSCH. Bolivia has designated only an NFP from the perspective of Administrative Governance. Not only has little related information been uploaded, but there are also almost no public data, including ABS genetic resource information, implementation procedures, and implementation examples. Compared to Colombia, Ecuador, Peru, ABS national implementation is the slowest. Colombia has designated an NFP and CNA from the perspective of Administrative Governance. The NFP and CNA in Colombia are solely designated by the Ministry of Environment and Sustainable Development, so it can be said that the convenience of access to information and the administrative efficiency for providing information are high. In Institutional Governance, Colombia registered 10 MSRs, the highest number of MSRs uploaded of the four countries. Colombia is focusing on specifying ABS domestic laws, policies, and regulatory procedures. In Data Governance (including Information Sharing), Colombia has registered 1 NDB, but the website link cannot be opened. Continuity in data management and continuous updating of information appear to be necessary. Ecuador has designated an NFP, CNA, and CP. In particular, for the CNA and CP, Ecuador has designated multiple ministries and agencies, which increases the complexity of ABS procedures such as ABS access, PIC and MAT, and benefit-sharing, which can be seen as a factor along the dimension of Administrative Governance that makes implementation difficult. From the perspective of Institutional Governance, Ecuador has registered 6 MSRs that include the contents of GRs and Traditional Knowledge associated with GRs and intellectual property rights (IPRs). Peru has registered an NFP (1), CNAs (7), and CPs (2) in Administrative Governance. The CNA and CP in Peru comprise multiple ministries and agencies, which increases the complexity of ABS procedures such as ABS access, PIC and MAT, and benefit-sharing, which can be seen as a factor making implementation difficult. In addition, it is the only country to upload a National Report (NR). In Institutional Governance, Peru has registered 10 MSRs and 1 PRO. Most MRSs include the contents of GRs and Traditional Knowledge associated with GRs, protect against acts of biopiracy, and support capacity-building. In 2021, Peru revised the Access to Genetic Resources and Their Derivatives to adapt the Nagoya Protocol and Andean Decision 391 (1996) to national realities. Peru is focusing on further specifying the scope and implementation procedures of ABS for genetic resources. In Data Governance (including Information Sharing), Peru has registered 4 NDBs, but some links cannot be opened. Continuity in data management appears to be necessary. Peru has issued the most IRCCs of the four countries in Domestic and International Cooperation Governance. Most IRCCs in Peru are for non-commercial agreements. Compared to other Andean countries, ABS compliance can be seen as the most active in Peru. The Andean region countries (all four countries) display obstacles in common in conformity with the four Governance realms (Administrative Governance, Institutional Governance, Data Governance (including Information Sharing), Domestic and International Cooperation Governance). However, the governance analysis results of the statistical analysis in Chapter III and of the individual countries in the literature survey in Chapter IV are somewhat different. Bolivia from the perspective of Administrative Governance has obstacles in non-persistent R&D investment and lack of private participation in utilizing and commercializing biological resources. From the perspective of Institutional Governance, Bolivia requires a variety of other contracts when making access agreements for genetic resources. This increases the transaction costs and risks borne by the petitioner. Particularly in contracts for knowledge and skills, there are high transaction costs and risks to investment security. In addition, there is the debate over the interpretation of existing laws (i.e., Decision 391). In Data Governance (including Information Sharing), illegal extraction of potential resources has become more prevalent, and the location information of vouchers is being managed increasingly strictly in Bolivia. From the perspective of Domestic and International Cooperation Governance, Bolivia has a particular conflict between the internal interests of traditional communities, local governments and development goals, and the external interests of multinational corporations and other parties pushing for the implementation of multilateral agreements. From the perspective of Administrative Governance, Colombia appears to have difficulties in applying relevant requirements and ensuring legal certainty with PIC. Building a functional domestic ABS system requires greater clarity on PIC and MAT requirements, particularly where indigenous peoples and local communities are involved. In Institutional Governance, Colombia needs negotiation skills due to the excessively conservative and risk-averse attitude of private enterprises toward commercial purposes. In Data Governance (including Information Sharing), Colombia has no linkage between academia and companies due to issues such as intellectual property rights although the government has invested financial resources into the development of genetic resources, and lack of knowledge about scientific methods and objectives makes it difficult for administrative authorities to evaluate scientific research proposals submitted for ABS access requirements. In Domestic and International Cooperation Governance, the continued violence by armed groups and criminal groups against rural, indigenous, and black communities is also considered an obstacle. From the perspective of Administrative Governance, Ecuador has a lack of research facilities, a brain drain of young researchers, low pay and poor treatment for researchers, and a poor research infrastructure (environment) that forces researchers to leave the field. There is also a lack of infrastructure and equipment for research and of negotiation capacity for technology transfer. In Institutional Governance, Ecuador has the obstacle of conformity with existing laws (i.e., Decision 391). In addition, in Ecuador, the development of commercial applications has largely failed, resource providers have derived only limited benefits, and incentives for biodiversity conservation have been limited, which constitute obstacles. There is a debate on the Buen Vivir concept that enshrines the rights of nature and its application to public policy. In Data Governance (including Information Sharing), Ecuador has a lack of highly specialized taxonomists and a need for further research and improved knowledge of BES (Biodiversity and Ecosystem Services). In Domestic and International Cooperation Governance, Ecuador has conflicts among stakeholders (i.e., local NGOs) in the access and commercialization process, as well as over profit sharing between companies and indigenous communities. From the perspective of Administrative Governance, Peru has weak monitoring and supervision regarding compliance with the terms and conditions of access contracts. In Institutional Governance, Peru is struggling to update its procedures and regulations to respond in a timely manner to researchers and other stakeholders requesting formal access to genetic resources and financial difficulties. There is poor coordination between authorities granting access to genetic resources and traditional knowledge. Further clarity is still needed on the responsibilities of the various authorities and the parameters of benefit-sharing negotiations. In Institutional Governance, on the user side, the financial benefits are considered too high by private companies, and on the provider side, indigenous peoples and local communities have limited knowledge of the legal framework and are unable to control illegal access by domestic and foreign users. In Data Governance (including Information Sharing), Peru’s obstacle is that the procedures for accessing genetic resources are complex and bureaucratic. In Domestic and International Cooperation Governance, Peru has a strict regulatory system to apply the Nagoya Protocol, but management and operational failures have led to calls for more training in ABS systems among the actors involved in the process: authorities, national and local officials, scientific communities, indigenous communities, and the general public. 과거에 생물유전자원은 인류공동의 자산으로 인식되어 어느 국가나 자유로운 접근 및 이용이 가능하였다. 그러나 급격한 기후변화와 재난 및 재해로 인해 생물다양성이 급격하게 감소되고, 유전자원의 경제적, 상업적 가치가 점점 증대되면서, 인류의 공동자산임에도 선진국들이 유전자원을 이용하여 얻은 이익을 배분하지 않고 독점하고 있다는 개발도상국들의 주장이 이어지자 1992년 ‘생물다양성협약’이 마련, 1993년에 발효되었다. 생물다양성협약 체결 이후 세계 각국은 유전 자원에 대한 근본적인 인식을 달리하게 되었다. 생물다양성협약으로 인하여 유전자원에 대한 국가의 주권적 권리를 인정하게 되었으며, 생물다양성의 보전과 그 구성 요소의 지속가능한 이용 및 생물유전자원의 이용으로부터 발생되는 이익 공유를 위한 국제적인 틀을 마련하게 되었다. 유전자원에 대한 국가의 주권적 권리 인정은 생물다양성협약 채택 시작부터 주된 관점이었으나, 이에 대한 실질적 논의는 오랜 동안 이어져왔다. 특히, 생물다양성협약의 세번째 목적인 유전자원의 이용으로부터 발생되는 이익의 공정하고 공평한 공유를 달성하기 위해 당사국간 논의가 활발히 진행되어 왔으며, 그 결과 2010년 제10차 생물다양성협약 당사국 총회에서 ‘나고야 의정서’가 채택되고, 2014년 발효됨에 따라 생물유전자원에 대한 접근 및 이용으로 발생되는 이익의 공평한 배분에 대한 이행 방안이 마련되었다. 유전자원에 대한 접근과 이익 공유(ABS)에 대한 국제레짐 논의에서 가장 중요한 핵심요소는 유전자원 및 전통지식에 대한 접근(Access), 이익 공유(Benefit-Sharing), 이행준수(Compliance)이다. 유전자원과 유전자원 관련 전통지식을 이용하는 국가는 그 자원을 제공하는 국가에 사전통보승인(Prior Informed Consent, PIC)을 받아야 하며, 유전자원의 이용으로 발생한 이익은 상호 합의된 계약조건(Mutually Agreed Terms, MAT)에 따라 공유해야한다. 대부분의 국가는 CBD 및 나고야 의정서에서 요구하는 ABS에 관한 국제 협약에 참여하고 있다. 그럼에도 불구하고 ABS 국가 시행은 잘 진행되지 않고 있는 것이 현실이다. 본 연구는 ABS 국제레짐의 발전 과정과 개별 국가별 참여 정도와 수준을 나타내는, 다시 말해서 ABS 레짐 발전을 가늠할 수 있는 ABSCH 메커니즘을 통해 레짐 의 발전 현황을 실증적으로 검증해 보고자 한다(3장). 특히 레짐에 참여하는 개별 국가-지역-국제적 수준에서 차이는 무엇인지를 고찰해 보았다. 특히 본 논문에서는 생물다양성이 풍부한 안데스 국가들을 분석 대상으로 이들 국가들의 ABS 레짐 참여 정도는 물론, 레짐 형성에 기여해 온 다양한 국내 이해관계자들 사이의 차이점과 이로 인해 발생하는 다양한 갈등과 문제점을 다층 거버넌스 차원에서 분석 관찰해 보고자 했다. 본 연구에서는 국제적, 지역적, 국가적 차원에서 ABS 대응 및 이행이 서른 상이한 이유는 물론, 특히 개별 국가별 이행에 있어 다양한 국내 이해관계자들 사이의 차이점을 다층 거버넌스 (Multi-level Governance, MLG) 개념을 활용해 살펴보았다. 본 연구는 다층 거버넌스(MLG)의 관점에서 현 CBD 체제 하의 ABS 레짐 형성과 가장 관련이 있는 나고야 의정서를 특히 국제적 차원에서 면밀히 관찰하고 분석한 후, 지역 수준(예를 들어 유전자원 접근에 관한 공통 체제에 관한 결정문 391에 초점을 맞춘 ABS 안데스 레짐)을 살펴보았다. 마지막으로 제4장에서는 사례연구 대상으로 선정한 안데스 국가(볼리비아, 콜롬비아, 에콰도르, 페루)의 국가별 거버넌스 분석을 통해 개별 국가별 ABS 레짐과 이행 과정에 대한 거버넌스 분석을 진행했다. 특히 ABSCH 메커니즘을 통해 확인된 다양한 변수들을 다층 거버넌스 개념을 통해 재구성, 예를 들어 행정 역량(행정 거버넌스), 제도 발전(제도 거버넌스), 정보 공유 시스템 구축(데이터 거버넌스), 국내외 협력 메커니즘 강화(국내외 협력 거버넌스)으로 재분류해 연구 대상 국가들의 ABS 시스템 이행 과정에서 나타난 다양한 유형의 거버넌스 부재와 한계를 관찰해 보았다. 거버넌스에 참여한 대표적인 이해당사자 혹은 행위자들로는 중앙정부, 지자체, 국내외 다양한 기업, 연구소, 지역주민, 특히 이 지역의 원주민 공동체, NGOs, 심지어 생물자원까지 포함(최근 일부 지역 국가에서는 생물자원에 대한 자연권 부여)되어 분석되었다. 제3장에서는 ABS 정보공유체계(ABSCH)의 자료를 활용하여 통계분석 방식으로 ABS 이행 현황과 이행 정도를 살펴보았다. 나고야 의정서, ABS 시스템 준수와 평가시스템(ABSCH)에서 분류된 10개 조치들을 수평적, 확장적 개념에서 수용해야 하지만 본 연구에서는 4개 카테고리(행정, 제도, 데이터, 협력)로 재분류해 ‘집중과 선택’ 차원에서 거버넌스 정도와 수준을 분석하였다 (제4장). 분석 대상 국가들의 ABS 레짐 참여 및 이행 수준을 다층 거버넌스 관점에서 분석한 결과들은 다음과 같다. 볼리비아는 행정 거버넌스 측면에서 R&D 투자가 지속 되지 못하고, 생물자원 활용 및 상업화에 대한 민간 참여가 부족한 상황이다. 제도적 거버넌스의 관점에서 볼리비아는 유전자원에 대한 접근 계약을 체결할 때 다양한 기타 계약을 요구한다. 이로 인해 청원인이 부담하는 거래 비용과 위험이 증가한다. 특히 지식과 기술에 대한 계약의 경우 거래 비용이 높고 투자 보안에 대한 위험이 있다. 또한 현행법(예: 판결 391)의 해석에 대한 논란도 있다. 국내 및 국제 협력 거버넌스 측면에서 볼리비아는 특히 원주민 공동체, 지방 정부 등과 다자간 협정 이행을 추진하는 다국적 기업 및 기타 이해당사자의 외부 이익 사이에 갈등도 ABS 레짐 이행을 어렵게 하는 원인으로 분석되었다. 콜롬비아는 행정거버넌스 측면에서는 PIC에 대한 관련 요구사항 적용 및 법적 확실성 확보에 어려움이 있는 것으로 보인다. 기능적인 국내 ABS 시스템을 구축하려면 특히 원주민과 지역 사회가 관련된 경우 PIC 및 MAT 요구 사항을 더욱 명확하게 해야 한다. 제도적 거버넌스 측면에서 콜롬비아는 상업적 목적을 위한 민간기업의 지나치게 보수적이고 위험 회피적인 태도로 인해 협상 능력이 필요하다. 정보 공유 또는 데이터 거버넌스 측면에서 고찰된 콜롬비아의 애로사항은 정부가 유전자원 개발에 재원을 투자했지만 지적 재산권 등의 문제로 인해 학계와 기업 간의 연계가 어려우며, ABS 접근 요구 사항을 위해 제출된 과학 연구 제안서를 평가하기 위한 과학적 방법 및 목표에 대한 지식이 부족하다는 한계가 있다. 국내 및 국제 협력 거버넌스에서는 농촌 지역 사회, 원주민 및 흑인 지역 공동체에 대한 무장 단체 및 범죄 집단의 지속적인 폭력이 여전히 이행을 더디게 하는 장애 요소로 분석되었다. 에콰도르는 행정 거버넌스 측면에서 볼 때, 연구시설 부족, 젊은 연구자들의 두뇌유출, 연구자에 대한 낮은 임금과 열악한 처우, 그리고 연구자들이 현장을 떠나게 만드는 열악한 연구 인프라(환경) 등이 거버넌스 한계로 관찰되었다. 생물자원 분야 연구를 위한 인프라와 장비도 부족하고, 기술이전을 위한 협상 역량도 부족했다. 제도적 거버넌스 측면에서 에콰도르는 기존 법률(예: 결정 391)을 준수하는 데 상당한 장애가 있다. 또한, 에콰도르에서는 기술사업화 추진의 어려움, 자원 공급자가 받게 되는 제한된 이익, 생물다양성 보전을 위한 인센티브 제한 등이 거버넌스 한계로 고찰되었다. 또한 자연의 권리를 존중하는 '부엔 비비르(Buen Vivir)' 개념을 공공 정책에 적용하는 과정에서 이해 당사자 간 상당한 갈등과 충돌이 있어 역시 거버넌스 한계를 드러냈다. 정보 공유 또는 데이터 거버넌스에서 에콰도르는 고도로 전문화된 분류학자가 부족하고 생물다양성 및 생태계 서비스에 대한 추가 연구와 향상된 지식이 필요하다. 에콰도르는 국내외 협력거버넌스 분야에서 이해관계자(현지 NGO단체 등)간 접근 및 사업화 과정에서 갈등을 경험해 오고 있으며, 특히 기업과 원주민 공동체 간 이익 공유를 둘러싸고 많은 갈등을 경험하고 있다. 페루는 행정 거버넌스 측면에서 규정 준수에 대한 모니터링 및 감독 부문이 취약한 것으로 관찰되었다. 접근 계약 조건과 관련하여 페루는 유전자원과 전통지식에 대한 공식적 접근과 재정적 어려움을 요청하는 연구자 그룹이 다수 존재한다. 기타 이해관계자들에게 시기적절하게 대응하기 위한 제도적 거버넌스 측면, 예를 들어 절차와 규정을 업데이트하는 데 행정적 어려움을 경험하고 있다. 제도적 거버넌스 측면에서는 사용자 측에서는 민간 기업이 금전적 이익을 너무 높게 간주하고, 제공자 측에서는 원주민과 지역 사회가 법적 틀에 대한 지식이 부족해 거버넌스를 달성하지 못하는 사례가 많다. 특히 국내외 사용자의 불법 접근을 통제할 수 없다는 것은 큰 거버넌스 부재로 관찰되었다. 정보 공유 또는 데이터 거버넌스에서 페루의 거버넌스 문제점은 유전자원 접근 절차가 복잡하고 관료적이라는 데에 있다. 국내 및 국제 협력 거버넌스에서 페루는 엄격한 규제 시스템과 프로세스에 참여하는 행위자(정부당국, 국가 및 지역 공무원, 과학계, 원주민 공동체)의 갈등이 거버넌스 문제점으로 관찰되었다.

합성생물학 유래 생물체(LMO)에 대한 국제법적 적용가능성 : 생물다양성협약 및 바이오안전성의정서를 중심으로

이선빈 중앙대학교 대학원 2022 국내석사

Synthetic biology is being discussed internationally in many fields such as science and technology, society, and the environment. Synthetic biology, which creates new results based on large-scale genome information, can be advanced to solve human problems such as climate change, poverty, and hunger with infinite development potential. In contrast to the positive aspects, however, the potential impact must also be considered to ensure safety. Synthetic biology, a newly discussed issue, does not even have a defined definition yet, and the regulation is not clear. Therefore, as discussions on the regulation of synthetic biology are being actively conducted internationally, this study aimed to explore the possibility of regulating synthetic biology under international law. Regarding the possibility of regulation under general international law, synthetic biology does not violate the national liability law but the state's responsibility cannot be avoided if it violates other international obligations as a result of synthetic biology. In addition, considerable care must be taken to ensure that research and commercial applications of synthetic biology do not cause environmental damage to other countries, and an environmental impact assessment should be carried out if there is a possibility of serious adverse effects on the environment. Now, the Conference of the Parties is discussing the regulation of synthetic biology based on the precautionary principle under general international law. In addition, it is necessary to examine the possibility of regulation in the relevant international conventions. First, in accordance with the Agreement on the Application of Sanitary and Phytosanitary Measures(SPS), import restrictions on components, organisms, and products made with synthetic biology technology can be set but mainly focused on trade-related measures, which cannot be defined as related to synthetic biology technology. Second, the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) may relate to sharing benefits from accessing and commercializing genetic resources for synthetic biology processes. Third, suppose a new plant variety is produced through synthetic biology research. In that case, it may be subject to “breeder’s right,” according to the International Union for the Protection of New Varieties of Plants (UPOV). In particular, if synthetic biology technology develops, produces, and stocks microorganisms, other biological agents, and various toxins, it may be subject to the Biological Weapons Convention (BWC). Fifth, although the International Plant Protection Convention (IPPC) has guidelines for the standard application of genetically modified organisms, there are no guidelines for components and organisms resulting from synthetic biology technology. Lastly, if synthetic biology is an invention that complies with patentability standards, it can be guaranteed a patent under the WTO Trade-Related Intellectual Property Rights Agreement (TRIPs). Regulations under international conventions will vary depending on how the definition and scope of synthetic biology are defined. Synthetic biology is now being actively discussed in the Convention on Biological Diversity, the Nagoya Protocol, and the Cartagena Protocol. First, it acknowledged that synthetic biology is a cross-issue in the Convention on Biological Diversity, and admits that it is necessary to review the Cartagena Protocol and the Nagoya Protocol annexed to the Convention. Therefore, it is necessary to examine the applicability of synthetic biology under the Nagoya Protocol and to define whether the components, organisms, and products created in synthetic biology are “derivatives” as defined in the Nagoya Protocol. In particular, this paper has addressed in detail about relevance to LMOs and living organisms and modern biotechnology, risk assessment and management for synthetic biology, unintentional cross-border movement of synthetic biology organisms and emergency measures, and matters related to handling, transport, packaging, and identification of synthetic biology organisms which are described in the Cartagena Protocol. It is expected that the Convention on Biological Diversity and its Annex Protocols will continue to discuss synthetic biology in the future. Although it is unlikely, an international discussion comprehensively and coherently is required to minimize the potential impact that may appear on a large scale. Finally, enacting an appropriate domestic legislative procedure on synthetic biology would be necessary along with international discussions. 현재 국제적으로 합성생물학은 과학기술, 사회, 환경 등 많은 분야에서 논의가 되어지고 있다. 대규모 유전체 정보를 바탕으로 새로운 결과물을 만들어내는 합성생물학은 무한한 발전 가능성과 기후변화, 가난, 기아 등 인류 난제의 해결로 발전할 수 있다. 하지만 긍정적인 면에 반해 잠재적 영향도 생각을 해야 하며 안전성을 확보해야 한다. 합성생물학은 새롭게 논의되는 이슈로 아직 규정된 정의조차 없고 규제가 명확하지 않다. 이에 국제적으로 합성생물학 규제에 대한 논의가 활발하게 이루어지고 있으며 국제법상 합성생물학의 규제가능성에 대하여 알아보았다. 일반 국제법상 규제 가능성에 대하여 합성생물학이 국가책임법에 위반되지는 않지만 합성생물학의 결과물로 다른 국제적 의무를 위반하게 된다면 국가책임을 피할수 없을 것이다. 또한 합성생물학의 연구와 상업적 응용 분야가 타국가에게 환경적인 피해를 끼치지 않게 상당한 주의를 해야 하며 환경에 심각한 악영향을 초래할 가능성이 있다면 환경영향평가를 수행해야한다. 현재 당사국총회는 일반국제법상의 사전예방원칙을 바탕으로 합성생물학에 대한 규제논의를 진행하고 있다. 더불어 관련 국제 협약상 규율 가능성도 살펴볼 필요가 있다. 첫째, WTO 위생검역협정에 따라 합성생물학 기술로 만들어진 구성요소, 유기체 및 산물에 대한 수입 제한을 설정할 수 있지만 주로 무역에 관련 조치에 초점을 맞추었고 합성생물학 기술과 관련되었다고 정의할 수 없다. 둘째, 식량농업식물유전자원에 관한 국제조약(ITPGRFA)은 합성생물학 공정에 사용하기 위한 유전자 자원 접근 및 상업화로부터 발생하는 이익의 공유와 관련이 될 수 있다. 셋째, 합성생물학 연구로 새로운 식물 품종이 생산된다면 식물신품종보호에 관한 국제협약(UPOV)에 따라 “육성가 권리”에 해당 할수도 있다. 특히 합성생물학의 기술로 미생물 혹은 기타 생물학적 작용제, 여러 가지 독소를 개발, 생산, 비축한다면 생물무기금지협약(BWC)에 해당될 수 있다. 다섯째, 국제식물보호협약(IPPC)은 유전자변형생물체에 대해 표준 적용을 위한 지침이 만들어졌지만 합성생물학 기술로 인한 구성 요소 및 유기체에 대한 지침은 존재하지않는다. 마지막으로 합성생물학이 특허성 표준을 준수하는 발명이라면 WTO 무역관련 지적재산권협정(TRIPs)에 따라 특허를 이용할수 있게 된다. 국제 협약상 규율은 합성생물학의 정의와 범위가 어떻게 규정되느냐에 따라서 규제방법이 다양할 것이다. 현재 합성생물학은 생물다양성협약과 나고야의정서, 카르타헤나의정서에서 활발하게 논의되고 있다. 우선 생물다양성협약에서 합성생물학이 교차이슈임을 인정하고 협약 부속의정서인 카르타헤나의정서와 나고야의정서의 검토가 필요하다고 인정하였다. 이에 나고야의정서 조약상 합성생물학의 적용성을 살펴볼 필요가 있다. 합성생물학에서 생성된 구성요소, 유기체 및 산물이 나고야의정서에 정의된 “파생물”에 해당하는지 정의해야 할 필요가 있다. 특히 본 논문에는 카르타헤나의정서에는 LMO 및 생물체 그리고 현대바이오기술에 해당성, 합성생물학에 대한 위해성 평가 및 관리, 합성생물학 생물체의 비의도적 국가간 이동 및 비상조치, 합성생물학 생물체의 취급·운송·포장 및 식별에 관련된 사항을 자세히 서술하였다. 생물다양성협약과 부속의정서들은 앞으로 합성생물학에 대하여 꾸준한 논의가 진행될 것으로 예상된다. 가능성은 낮지만 거대한 규모로 나타날 수 있는 잠재적 영향을 최소화하는 전제로 포괄적이고 일관성있는 방식의 국제 논의가 필요하다. 마지막으로 국제 논의에 맞추어 합성생물학에 관한 적절한 국내 입법절차를 제정해야 할 필요가 있다. 目前,国际领域对合成生物学在科学技术、社会、环境等诸多领域都进行了讨论。以大量基因信息为依托并创造出新成果的合成生物学存在无限的发展可能性,并可解决气候变化、贫困、饥饿等人类难题。但是,考虑积极一面的同时,还要考虑潜在的影响以确保安全性。合成生物学是新讨论的话题,目前还没有规定的定义,限制也不明确。对此,国际上正在积极讨论合成生物学的限制问题,并找寻国际法层面上的合成生物学限制的可能性。 对于一般国际法上的限制可能性,合成生物学虽然不违反国家责任法,但是合成生物学的结果如果违反其他国际义务,将不可避免地承担国家责任。 另外,合成生物学的研究和商业应用领域要相当注意,以免给其他国家造成环境损失,如果有可能对环境造成严重负面影响,就要进行环境影响评价。 目前,当事国总会正在以一般国际法的事前预防原则为基础,对合成生物学进行限制讨论。 同时,有必要观察相关国际协议中的规律可能性。第一,根据WTO卫生检疫协定,虽然可以设定对合成生物学技术制造的构成要素、有机体及产物的进口方面进行限制,但将焦点放在贸易相关措施上,不能定义为与合成生物学技术有关。 第二,粮食农业植物遗传资源相关国际条约(ITPGRFA)可能与用于合成生物工程的遗传资源接近,与商业化产生的利益共享有关。第三,如果通过合成生物学研究生产出新的植物品种,根据《植物新品种保护国际公约》(UPOV),可以相当于是"培育的权利" 。特别是利用合成生物学技术对微生物、其他生物学作用剂、多种毒素进行开发、生产、储备,就相当于违反《生物武器禁止公约》(BWC)。 第五,《国际植物保护公约》(IPPC)虽然制定了转基因生物体适用标准的方针,但是不存在合成生物学技术引起的构成要素及有机体的方针。 最后,如果合成生物学是遵守专利性标准的发明,那么根据WTO《与贸易相关的知识产权协定》(TRIPs)可以使用专利。 根据国际协议的规律,如何规定合成生物学的定义和范围,规制方法将多种多样。《生物多样性公约》、《名古屋议定书》和《卡塔赫纳议定书》对合成生物学问题目前正在积极讨论。首先,在《生物多样性公约》中承认合成生物学是交叉焦点,《卡塔赫纳议定书》和《名古屋议定书》主张讨论是有必要的,公约附属议定书也对此表示认可。因此,有必要分析《名古屋议定书》条约对合成生物学的适用性。有必要对合成生物学中生成的构成要素、有机体及产物是否属于《名古屋议定书》定义的"衍生物" 进行定义。特别是本论文中《卡塔赫纳议定书》详细叙述了LMO、生物体以及现代生物技术的相关性、对合成生物学危害性的评价及管理、合成生物学生物体非意图的国家间移动及紧急措施、合成生物学生物体的处理、运输、包装及识别等相关事项。预计《生物多样性公约》和附属议定书今后将继续对合成生物学进行讨论。 虽然可能性很低,但有必要考虑巨大规模出现时潜在影响的处理方法,以此为前提,需要以全面一贯的方式进行国际讨论。 最后,有必要根据国际讨论制定适当的国内立法程序。

유전자원 출처공개 및 보호에 관한 비교법적 연구 : 한국과 중국을 중심으로

곽육보 중앙대학교 대학원 2023 국내석사

유전자원은 실제적 또는 잠재적 이용 가치가 있는 유전정보로써, 모든 생물이 지니는 자신의 유전현상을 표현한다. 유전자원은 생물다양성의 보호와 생물과학의 발전과 관련되어 있어 유전자원의 보호는 세계 각국이 대면해야 할 중요한 문제이다. 본 논문은 한국법, 중국법 및 국제협정의 유전자원 보호에 관한 이론적 기초와 실제 문제를 분석함으로써 유전자원 보호에 관련 규정의 개선방안을 연구한다. 1980년대 이후 생명과학 분야는 유전자공학의 대두와 함께 크게 변화하고 생명과학을 핵심으로 한 현대 바이오 기술의 발전과 응용도 크게 진보하였다. 제4차 산업혁명 시대에 국제사회에서는 생물과 유전자원 및 관련 전통지식에 대한 관리와 보호인식이 점차 강화되고 있다. 생물다양성협약의 3대 목적 중 󰡒발생하는 이익을 제공자와 이용자가 서로 공정하고 공평하게 공유하도록 한다󰡓는 목적을 이행하기 위해 채택된 나고야의정서는 당사국들에게 동 의정서의 성공적인 국내이행을 위하여 적절한 입법적, 행정적 또는 정책적 조치를 취하도록 하고 있다. 나고야의정서는 생물유전자원과 관련 전통지식까지 ABS에 포함하고 유전자원 접근 시 사전통보승인이 필요하며 유전자원 접근과 이익공유에 대해 유전자원 제공자와 이용자 간에 상호합의조건의 체결이 필요하다고 규정하였다. 생물다양성협약에 참여하는 중국, 브라질, 인도 등 개발도상국들은 출처공개제도를 도입하였다. 중국의 전리법 및 전리법 실시세칙 등에 따르면 유전자원 발명이 특허출원을 청구할 때 출원인은 청구서에 출원하려고 하는 발명이 어떠한 유전자원을 의존하여 창조되었는지 설명하고 출처공개 등기표를 작성하여야 한다. 이러한 출처공개제도를 두고 있지만 중국은 아직 이익공유, 벌칙 등에서 아직 미흡한 점이 있다. 한국은 중국처럼 출처공개제도를 도입하지 않았지만 나고야의정서의 국내 이행을 위하여 2017년에 「유전자원 접근 및 이익공유에 관한 법률」을 마련하였다. 한국은 주로 유전자원을 이용하는 이용국의 입장에서 유전자원의 접근 및 이익공유 조치에 대한 연구가 주로 이루어져 왔다. 그러나 한국은 다른 국가의 유전자원을 이용할 뿐만 아니라 여러 가지 형태의 유전자원을 보유하고 있으므로 유전자원을 보호하기 위한 연구도 진행하여야 할 것이다. 본 논문에서는 한국과 중국의 법률과 국제협정 등을 통하여 유전자원을 보호하고자 한다. 생물다양성협약 및 나고야의정서에서 추구하는 이익의 공정하고 공평하게 공유하는 목적을 이행하기 위하여 많은 국가는 출처공개제도를 도입하였다. 이러한 세계적 흐름에 맞추기 위하여 한국에서 출처공개제도를 도입할 경우 발생할 수 있는 문제점을 파악하여 구체적인 도입방안을 제시하고자 한다. 또한 중국에서 이미 시행되고 있는 출처공개제도와 이익공유에 관한 제도의 개선방안을 제시한다. "Genetic resources" means genetic material of actual or potential value where genetic material means any material of plant, animal, microbial or other origin containing functional units of heredity. Genetic sources are related to the protection of biodiversity and the development of bioscience, so the protection of genetic sources is an important issue that countries around the world must face. Analyzing of the theoretical basis and practical problems of genetic resource protection in Korean law, Chinese law and international agreements, this thesis studies measures to improves regulations related to genetic resource protection. Since the 1980s, the field of life science has changed significantly with the rise of genetic engineering, and the development and application of modern biotechnology centered on life science have also advanced significantly. In the era of the 4th Industrial Revolution, the management and protection awareness of living things, genetic resources, and related traditional knowledge are gradually being strengthened in the international community. Among the three purposes of the Biodiversity Convention, the Nagoya Protocol, adopted to fulfill the purpose of ensuring that providers and users share the profits fairly and fairly with each other, requires the parties to take appropriate legislative, administrative or policy measures for the successful domestic implementation of the protocol. The Nagoya Protocol stipulated that bio-genetic sources and related traditional knowledge are included in ABS, prior notification approval is required for access to genetic resources, and mutual agreement conditions are needed between genetic resource providers and users for access to genetic resources and benefit sharing. Developing countries such as China, Brazil, and India participating in the Biodiversity Convention have introduced a source disclosure system. According to China's Ionization Law and Ionization Law enforcement Rules, when a genetic resource invention claims a patent application, the applicant must explain what genetic source the invention is trying to apply for in the claim and fill out a source disclosure registration form. Although such a source disclosure system is in place, China is still lacking in benefit sharing and penalties. Although Korea did not introduce a source disclosure system like China, the "Act on Access to, Utilization and Benefit-Sharing of Genetic Resources" was established in 2017 to implement the Nagoya Protocol in Korea. In Korea, research on access to genetic resources and benefit-sharing measures has been mainly conducted from the perspective of countries using genetic resources. However, Korea has various types of genetic resources as well as using other countries' genetic resources, so research to protect them should also be conducted. In this thesis, I intend to protect genetic resources through laws and international agreements between Korea and China. In order to fulfill the purpose of fair and equitable sharing of interests pursued by the Convention on Biodiversity and the Nagoya Protocol, many countries have introduced a source disclosure system. In order to keep up with this global trend, we would like to identify problems that may arise when the source disclosure system is introduced in Korea and present a specific introduction plan. It also proposes ways to improve the source disclosure system and benefit sharing system already in place in China.

Identification of characteristic aroma constituents of Hadong wild green tea flower (Camellia sinensis (L) O. Kuntze) using GC/MS

김온유 Graduate School of Life and Environmental Science, 2018 국내석사

차나무(Camellia sinensis (L) O, Kountze)는 다년생의 상록관목으로 차나무의 잎, 꽃, 그리고 열매에는 폴리페놀, 토코페놀, 비타민, 사포닌, 필수원소 등이 다량 함유되어 있어 건강 기능을 증진시키는 대표적인 식품 원료로 알려져 있으며, 피부 기능성을 갖춘 화장품 원료로도 사용하고 있다. 녹차꽃은 기분을 고양시키는 특유의 신선하고 달콤한 꽃 향기를 가지고 있어 향료로서의 활용 가치가 높다. 특히 대한민국 경남 하동은 기온, 강수량, 토양 등 차나무 재배에 적합한 조건을 갖추고 있으며, 하동에서 자생하는 차나무는 지리산 등지의 야생 환경에서 서식하고 있어 일반적인 재배종과 달리 꽃의 향기가 더욱 화사하고 신선하며 매우 진하고 강하다. 본 연구에서는 우리 나라 하동의 녹차꽃을 대상으로 야생 녹차꽃을 구성하는 고유의 향기 성분을 동정하기 위해 실험을 수행하였다. 향료 성분을 추출해내는 과정에서 각 방법의 단점을 보완하기 위하여 SPME 전처리 방법, 용매추출법, 초임계 추출법을 도입하여 GC/MS로 향기 성분을 확인하였다. 초임계 추출의 경우 신선한 녹차꽃과 동결 건조한 시료를 추출하고 각각 extract를 얻어 분석했다. 녹차꽃 SPME-GC/MS 분석에서 확인된 휘발성 성분은 48종으로, ketone류(86.7975%%)가 생화의 휘발성 향기 성분에서 가장 많은 양이 검출되었고, ketone류에 포함되는 acetophenone이 전체 함량의 약 86%를 차지하였다. 녹차꽃의 향기 성분에 기여하는 main component로 확인된 성분은 acetophenone (86.3882%), perillene (5.2593%), 그리고 d-limonene (1.6822%)이다. 용매 추출법의 녹차꽃 absolute에서는 52종의 화합물이 분리확인 되었으며, alcohol 류 (13.4794%), ketone류(64.8656%)가 absolute의 대부분을 구성하고 있다. 녹차꽃 absolute에서 확인된 주요 성분은 acetophenone (64.3686%), styralyl alcohol (11.6969%), 그리고 linalool(1.1976%)이며, 향기의 thresholds가 낮은 nerol(0.0795%)이 미량 함유되어 있는 것을 발견하였다. 녹차꽃의 생화 초임계 추출의 분석 결과 총 58종의 화합물이 검출되었으며, alcohol류가 44.1505%로 가장 많은 양이 함유되어 있고, ketone류는 21.1286%, aldehyde류가 2.1100%로 생화 extract의 주요 화합물로 확인됐다. 특히 생화 extract에서 styralyl alcohol(34.7100%)이 가장 많은 양을 차지하였고, acetophenone (18.2843%), beta-phenyl ethyl alcohol (5.5564%), methyl ortho-anisate (1.8703%), methyl benzoate (1.3706%), hexahydrofarnesyl acetone (1.0603%)가 검출되어 floral odor가 특징인 main components가 많이 함유되어 있음을 확인하였다. 동결 건조한 녹차꽃의 초임계 추출에서는 29종의 화합물을 발견하였는데 녹차꽃의 유의미한 휘발성 향기 성분이 많이 소실되었다. 동결 건조과정을 거친 녹차꽃 extract의 주요 향기 성분은 acetophenone (15.9118%) 및 styralyl alcohol (6.3800%), hexahydrofarnesyl acetone (6.1416%), 그리고 2-pentadecanone (4.887%)으로 동정되었다. 특히 lactone류의 dihydroactinidiolide가 검출되었는데, 이 물질은 apricot, black tea aroma의 특징을 가지고 있으며, 하동 야생 녹차꽃만 가지는 고유 향기 성분으로 확인되었다. SPME, 용매 추출, 초임계 추출을 통해 동정된 하동 야생 녹차꽃 향기 성분을 종합한 결과 발견된 휘발성 성분은 총 146가지로, 공통으로 확인된 주요 향기 성분은 acetophenone과 styralyl alcohol이었고, 하동의 녹차꽃 향기에 기여하는 성분은 총 42종으로 확인됐다. 또한 선행 연구에서 확인된 보성과 제주 녹차꽃의 향기 성분을 본 연구 결과와 비교한 결과, benzyl alcohol, styralyl alcohol, acetophenone, beta-phenyl ethyl alcohol, linalool 등 총 11종의 동일 성분이 존재하였다. 최근 나고야 의정서(유전자원에 대한 접근 및 그 이용으로부터 발생하는 이익의 공정하고 공평한 공유에 관한 생물다양성에 관한 협약, Nagoya Protocol)에 따른 자국의 생물유전자원에 대한 관심이 급증하는 가운데, 우리 나라도 2017년 5월 19일 유엔 사무국에 비준서를 기탁하여 2017년 8월 17일에 당사국이 되었다. 나고야 의정서는 유전자원 및 관련 전통지식을 이용하여 발생한 이익을 제공하는 국가와 토착국 원주민 공동체와 공유하도록 함으로써 생물자원의 보전에 기여하기 위한 목적으로 채택되었다. 이러한 계기로 우리 나라도 국가 생물의 다양성을 보전하고 지속 가능한 이용에 기여하는 국제적인 노력이 필요하며, 해외에서 이용되는 우리의 유전자원에 대한 이익을 공유하는데 아낌없는 노력이 필요하다. 이에 본 연구는 한국의 자생 식물인 경남 하동의 야생 녹차꽃의 고유 향기에 대한 정보 기틀을 확립하고 이를 토대로 자국의 유전자원을 확보한다는 점에서 의미가 있다고 판단된다. A tea tree, Camellia sinensis (L) O. Kountze, is a perennial evergreen shrub that contains a large amount of polyphenols, tocopherols, vitamins, saponins, and essential elements in tea leaves, flowers and fruits. Tea tree is also known as a raw material for food that improves human health and also used as a cosmetic raw material for skin care. Green tea flowers are highly valued as spices because they have a distinctive fresh and sweet floral fragrance that enhances mood. In particular, Hadong, Gyeongnam in the Republic of Korea, has suitable conditions for growing tea trees because of its temperature, precipitation and soil. The tea trees that grow in Hadong live in the wild environment of Mt. Jiri. Unlike common cultivars, the fragrance of the flowers is lush, fresh, dense, and strong. In this study, we conducted experiments to identify the aroma components of green tea flowers in Hadong. To compensate each experimental methods, 3 different extraction methods, the Solid Phase MicroExtraction (SPME) pretreatment method, solvent extraction method, and supercritical extraction method, were employed to extract the aroma components. The components were identified by Gas Chromatography-Mass Spectrometry (GC/MS). In supercritical extraction, fresh green tea flowers and freeze-dried samples were extracted and analyzed. In the SPME-GC/MS analysis of green tea flowers, 48 volatile components were detected, and ketones (86.7975%) were found to be the most abundant in the volatile aroma components of the flowers. The major components contributing to the aroma components of green tea flowers were acetophenone (86.3882%), perillene (5.2593%), and d-limonene (1.6822%). In the solvent extraction method, 52 kinds of compounds were identified in the absolute oil of the green tea flower. Alcohols (13.4794%) and ketones (64.8656%) constitute most of the absolute. The major components identified in the absolute were acetophenone (64.3686%), styralyl alcohol (11.6969%), and linalool (1.1976%) and trace amounts of nerol (0.0795%) which has a low threshold of aroma. A total of 58 compounds were detected in the supercritical fluid extraction of the green tea living flowers. The content of alcohols was 44.1505% as the highest content; the ketones were 21.1286%; the aldehydes were 2.1100%. Especially, styralyl alcohol (34.7100%) was the most abundant in the extract, followed by acetophenon (18.2843%), beta-phenyl ethyl alcohol (5.5564%), methyl ortho-anisate (1.8703%), and methyl benzoate hexahydrofarnesyl acetone (1.0603%). It was confirmed that main components which are characterized by floral odor were contained in a large quantity. In the supercritical fluid extraction of freeze-dried green tea flowers, 29 compounds were found, but significant volatile aroma components of the green tea flowers were lost. The major aroma components of the green tea flower extract after freeze-drying were acetophenone (15.9118%), styralyl alcohol (6.3800%), hexahydrofarnesyl acetone (6.1416%) and 2-pentadecanone (4.887%). Especially, dihydroactinidiolide, a lactone, was detected. This material has an aroma of apricot and black tea and was identified as a unique fragrant ingredient of Hadong’s wild green tea flower. A total of 146 volatile components were found as the aroma components of Hadong’s wild green tea through SPME, solvent extraction, and supercritical fluid extraction. Acetophenone and styralyl alcohol were the major aroma components identified in common among the different extraction methods, and a total of 42 ingredients out of the 146 components were found to contribute to the fragrance. As a result of comparison of the aroma components of Boseong and Jeju’s green tea flowers found in the previous research, 11 kinds of common components, such as benzyl alcohol, styralyl alcohol, acetophenone, beta-phenyl ethyl alcohol and linalool, were present. With a recent surge in interest in a country's biological genetic resources under the Nagoya Protocol (the Convention on Biodiversity, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of the Benefits Derived from Its Use), the Republic of Korea became a party to ratify the protocol on 17 August 2017 after submitting an instrument of ratification to the United Nations Secretariat on May 19, 2017. The Nagoya Protocol was adopted for the purpose of contributing to the conservation of biological resources by sharing benefits derived from the use of genetic resources and related traditional knowledge with national and indigenous communities. With this in mind, we need international efforts to preserve the country's biodiversity and promote sustainable use, and share the benefits of our genetic resources used abroad. Therefore, this study is meaningful in that it establishes the information frame about the intrinsic fragrance of wild green tea in Hadong, the native plant of South Korea, and secures the species’ own genetic resources of the nation based on the frame.

유전자원의 이익공유에 관한 연구 - 남아프리카공화국을 중심으로

신희원 전북대학교 생명자원과학대학원 2020 국내석사

For the past many years, bio-genetic resources have been recognized as common heritage of mankind, and they have been freely accessed and used. However the demand for biodiversity following biotechnological progress and genetic erosion has brought a shift in such perception. This in turn resulted in the 1992 Convention on Biological Diversity (CBD). The Nagoya Protocol is a legal agreement that passed through the Bonn guideline. It abides international regimes to achieve the third objective of CBD which is the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. Following the adoption of the Nagoya Protocol, countries that provide genetic resources are demanding the countries that use genetic resources for a fair and equitable sharing of the benefits from the use of genetic resources in accordance with contractual agreements that include prior informed consent (PIC) and mutual agreed terms (MAT). These include the approaches of utilizing traditional knowledge associated with genetic resources for mutual benefits. In terms of biodiversity, South Africa is the third richest country in the world next to Indonesia and Brazil. However, the country’s biodiversity is at risk due to various factors associated with global warming, reckless habitat destruction, and invasion by exotic species. Having such a scenario, South Africa has established a National Environmental Management Biodiversity Act (NEMBA). It also established Regulations on Bio-Prospecting, Access and Benefit-Sharing (BABS) which are sub-regulations of NEMBA. The Biodiversity Act and BABS Regulations set out important requirements for those using indigenous biological resources. Anyone carrying out bioprospecting involving indigenous biological resources and, if applicable, associated traditional use or knowledge, requires a permit. Or anyone exporting indigenous biological resources for the purposes of bioprospecting or other research requires a permit. A permit will only be issued if there has been material disclosure to stakeholders, if their prior informed consent to the bioprospecting has been obtained and if the Minister is satisfied that certain conditions have been met as set out in the legislation. After a thorough examination of the world’s ABS regulation which is a legal and binding international treaty, and the South Africa’s ABS regulations on benefit-sharing between the genetic sources of Hoodia and Rooibos, the following suggestions were derived. First, In order to grasp the possibility of utilizing bio-genetic resources and protect traditional knowledge, it is necessary to closely investigate Korea's bio genetic resources and its traditional knowledge that are related to the utilization of genetic resources. Second, We can consider ABS system to protect bio-genetic resources and intellectual property as one of the defensive strategies. Third, From research on biological resource and traditional knowledge, I hope that Korea’s biodiversity and traditional knowledge can be protected adequately by the law and can be utilized for benefit-sharing to biological genetic resources.

植物新品種保護와 그 民事責任에 關한 硏究

이혜은 경희대학교 법학전문대학원 2014 국내박사

The international market of seeds of agricultural products has been increased from 24.7 billion dollars in 2002 to 42.6 billion dollars in 2011, or by 1.7 folds, and experts forecast that the market would grow by 7% per year until 2025. According to the International Seed Federation (ISF), the US occupied 28.1% of the seed market in 2011, the biggest share, and 80% of the market are occupied by the top 10 nations including China and France. South Korea, dreaming of being a power of seeds, only has 1% of the share in the market. The domestic seed industry has seriously been on the decline since the IMF crisis. After the crisis in 1997, the seed companies of No. 1 to 3 were merged into foreign companies, inducing issues of seed sovereignty. Although breeding techniques of rice, Chinese cabbage, red pepper, and white radish are world-class, South Korea has failed to develop varieties that capture the tastes of foreigners. The breeding techniques and genetic resources of onion, tomato, and paprika as globally popular seeds are sufficiently inadequate. The seed industry has been more and more spotlighted as the importance of securing breeding and relevant techniques is underlined, as well as the importance of seeds and varieties. The industry is getting more important on an international basis because it is recognized as the most critical industry providing foods for people and a significant property of a government, a main agent that has to protect food sovereignty. Many countries around the world intensify management of patents and genetic resources for strengthening food security, taking the lead in competition of seed development using secured genetic resources. The advanced countries has constructed systems for collecting, preserving, and assessing the genetic resources, operating systems of managing the resources at the national level. The seed industry has been a cutting-edge industry by convergence of various industries and acceptance of nano-technology, growing out of simple approaches of breeding by crossing hybridization. The advanced countries have constructed the seed industry as the national industrial foundation, intensifying support as a new growth industry, and, recently, investing a huge budget to preoccupy source technology. Rearing the seed industry may serve as a foundation for enhancing national competitiveness and protecting food security of South Korea that has been sufficiently vulnerable. Various countries established a special law based on their own patent law and the agreement of the International Union for the Protection of New Varieties of Plants (UPOV) in order to institutionalize protection of plant varieties, but there have been several cases in which progressiveness of patents were not satisfied because new varieties were discovered or developed by using the existing plant varieties due to development of science. Thus, double protection is needed with the patent law and the special law as use of patent is not facilitated. South Korea, America, and Japan are the countries to select the double protection with the patent law and the special law, and China does not accept the double protection. The EU and China are protecting new plant varieties with the special law. In South Korea, the scope of protection in the Patent Law and that of the Act of the New Plant Variety Protection were overlapped to some extent when the provisions of plant invention in Article 31 of the Patient Law revised in 2006. There may be cases of the forces of rights between the Act of New Plant Variety Protection and the Patient Law are infringed in theory, thus requiring provisions of adjustment between the two. However, the Patient Law of South Korea is absent of such provisions of adjustment. As seen in mingling of the patent law for manufacture method and that for products, the patentee should be limited as the one applied for the patent before the application day of the plant variety between absolute exclusive rights, and the relation between absolute exclusive rights after the general rights become extinct should be interpreted as intellectual property rights in the narrow sense. Although the Act of the New Plant Variety Protection and the Patent Law need “novelty” as a requirement of registration, both are different in significance and period of acknowledgment of exception of it. The domestic seed industry, familiar to the exception provisions established in the Act of the New Plant Variety Protection, may be confused from the protection by the Patent Law, a law that does not accept the exception. As for cases that a farmer gather seeds of a new variety that is double registered on the basis of the Patent Law and the Act of the New Plant Variety Protection, seed gathering of some varieties are accepted by the Act but are infringed of the Patent Law, probably followed by legal limitations. In this context, institutional strategies should be provided for mediation of such conflicts. As for measures to reduce problems from the conflicts, it is needed to reduce occurrence of conflicts in the process of producing rights as in the traditional Intellectual Property Right or to accept provisions to mediate conflicts after production of rights. In the invention of a new plant variety, it may be desirable to recognize repetitive reproduction in cases that the explanation of invention is detailed to an extent that the reproduction of breeding can be admitted with probability. There are many cases in which the repetitive reproduction is not sufficiently satisfied as a requirement of writing due to the property of plant invention, however, and it is needed to activate a deposit system as an initial phase of operation and to supplement the system. In inventions related to a new plant variety, breeding processes are hard to be fully written in the detailed explanation of the invention. The deposit system of microorganisms such as cells and seeds is being operated in order to solve the issues, and it is needed to establish examination standards and to actively promote the system. As for activation of the deposit system, the self deposit system in Japan can be considered; in the system, the means of acquisition are written in the statement and the distribution is guaranteed by the applicant for the patent when the deposit of the relevant replicable plant variety is not possible due to technical reasons of the consigned agent. The self deposit system may be useful when the existing deposit system is not able to be used when the relevant plant is hard to be reproduced with the seeds or cells due to the property of the species of fruit trees or shrubs. Recently seeds have been an important factor in food supply in the future, serving as the source of development of future promising industries such as food, environment-friendly energy, and medical supplies. Also, seeds developed or invented play an important role in enhancing productivity and creating added value of agriculture. Some seeds were developed from the existing breeding. However, the genetically modified (GM) seeds for functionality are recognized as important productions for resolving food issues in developing countries but poses controversies because of insecurity in safety as of present. The Cartagena Protocol on Biosafety established procedures to prevent environmental damage based on movement of genetically modified organisms, responsibilities, and procedures governing the settlement of disputes. The Nagoya-KualaLumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety added and supplemented contents related to responsibility and relief, a content that is only formal and does not carry legal binding force, for significant items related to the responsibility and relief are entrusted to domestic laws. The countries directly involved can apply responsibility system appropriate for their situation to the genetically modified organisms. Countries importing the GM products may secure possibility to hold exporters responsible for damage caused by the products, but international conflicts may arise because the safety of the GM products can be asserted by the exporters or developers on the basis of safety assessment and approval of importing. When a firm producing GM seeds makes a contract of seed sales with a farmer of GM plants, the firm can inquire into responsibility for the farmer if the contract is violated. On the contrary, a farmer who purchased GM seeds can claim for damage based on the contract to the firm producing the GM seeds or those who supplied seeds when the requirements of default are met if the output of the GM seed falls short of expected production or the property of the seed causes damage to surrounded farmland or crops and consequent damage to people. Those who suffer damage from events caused by GM seeds or the processed goods can be lessened of the burden of proof liability by conversion of the proof liability or actual estimation of fault and argue establishment of illegality to accept compensation. As for GM seeds and the processed goods, the damage actually suffering the victim can be compensated, but issues of potential risk can be excluded of illegality. Risk liability does not require illegality of a harmful act and in consequent is not applied of the theory of the limit of sufferance, thus needing establishment of relevant provisions. Responsibility by the tort law can be called because a causal relationship is regarded to be proved between the actions of producing, distributing, and supplying the GM seed and its processed goods of the assailant and the damage of the victim, if the facts that the GM seed and its processed goods were produced, distributed, and supplied, that the GM seed and its processed goods reached bodies or properties of the victim, and that the bodies or properties of the victim were damaged are verified without contradiction. In South Korea, the Product liability Law is applied only to processed agricultural, marine, livestock products, and the problem is about the GM seeds and the foods processed from the processed goods. The products of the GM crops applied of the GM technology can be applied of the Product liability Laws if the GM crops may be interpreted as processed assets because the crops are products processed by scientific technology. Responsibility for faults or causal relationship that is not able to be proved by modern scientific technology can be avoided as long as a plea of development risk is accepted as a cause of exemption of product liability. Furthermore, distribution of GM seeds and the processed products that observe all the laws and regulations established by the government via risk assessment of the seeds and the products may be exempt from observation of laws and ordinances. In order to clarify legal relations, it is needed to revise laws, as seen in cases of the EU, or to establish a special law in which the properties of GM seeds and the processed products are considered.