유전자원 보호와 활용을 위한 국제적 논의와 쟁점에 관한 소고

허인(HUH, In),심현주(SHIM, Hyunjoo) 세창출판사 2013 창작과 권리 Vol.- No.71

Genetic resources and its relation to the protection of intellectual property is a controversial issue which has been one of the agendas of TRIP regarding biological diversity for the last ten years. Most of the nations agree with the protection of genetic resources and related traditional knowledge but the issue is how to do so. In order to resolve this problem, WIPO IGC was established in 2000 and up until now, they are discussing issues including access and benefit sharing and matters over intellectual property rights regarding traditional knowledge and folklore. With the adoption of 「Convention on Biological Diversity(CBD)」 in 1992, balanced stance and practical approach method to genetic resources is defined as a binding regulation. This convention ensures conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources and sovereignty of countries on Genetic Resources. Facing the year 2010 the year which UN has declared to be the International Year of Biodiversity, has hosted 10th Conference of the Parties(COP) in Nagoya, Japan and adopted 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」. This is a historic event in the scene of Access and benefit-sharing(ABS) of biodiversity. The adoption of the ABS Protocol and the following new ABS standards are expected to influence the discussion of WIPO IGC and TRIPS Council. In the WIPO ICG conference and the discussion related to having PIC and MAT mandatory in relation to the TRIPS and CBD, considering relevant matters of the ABS in patent-related works will be discussed. However, it should be noted that the purpose of the Convention on Biological Diversity and ABS Protocol is to preserve the biological diversity through the ABS on genetic resources and related traditional knowledge, and to contribute to the sustainable use of its components while the objective of the discussion of WIPO IGC is to protect genetic resources and traditional knowledge or to preserve them as an intellectual property. In the conclusion, minimum standards which were required by global community on access to genetic resources and benefit sharing need to be set forward to ensure stable and long-term protection of domestic genetic resources and its utilization. In the field of genetic resources, there is a possibility that we would be able to solidify our status as a user nation due to the continuous development of the bio-industry which comes after the advancement of biotechnology. Therefore, we should take counter measures on separate issues considering the stance of user nations in global discussions relevant to the field of genetic resources and traditional knowledge.

한국 농업에서의 유전자원 활용 현황과 금후 전망

김창영,이정란,윤문섭,조규택,백형진,고호철,조양희,전영아,김정곤 한국국제농업개발학회 2010 韓國國際農業開發學會誌 Vol.22 No.3

농업유전자원의 그동안 활용상황을 리뷰를 통하여 살펴보고 금후의 적극적인 활용방안을 모색하기 위하여 해방후 한국 농업의 시대적 변천에 따른 농업특성과 유전자원의 활용 상황, 국가농업유전자원은행의 역할과 금후 유전자원의 활용 전망에 대하여 검토하여 본 바를 요약하면 다음과 같다. 1. 해방이후 우리나라 농업의 시대적 변천상황은 1960년대 이전은 자급형 영세농업의 시대로서 한국고유 재래종 위주 재배에서 외국품종 도입 및 국내품종 육성초기의 시대였고, 1960~1970년대는 국가적 식량문제 해결시대로서 통일벼 육성·보급 재배에 따라 다수성 품종육성을 위한 유전자원의 필요성이 대두되었고, 1980~1990년대는 농산물 소비 다양화시대로서 엽채류, 과채류의 이용성 증가로 4계절 재배가 가능한 원예작물의 육성 및 보급이 이루어졌으며, 2000년대 이후는 고부가 가치 농업을 추구하는 시대로 변천하였으며 시대적 변천에 의한 고품질, 기능성 작물재배가 증가함에 따라 다양한 형질의 유전자원 및 수출경쟁력 있는 품종을 요구하고 있다. 2. 농촌진흥청은 국가 농업유전자원 종합관리를 위하여 농업유전자원 관리기관 91개소를 지정운영 하는 등 국내외적으로 역할을 확대하고 있으며, 식물종자유전자원을 중기 및 장기보존 각각 50만점 저장이 가능한 첨단시설을 갖추고 현재 종자자원 16만점을 보존하고 있으며, 이들 유전자원을 활용하여 2,477품종을 개발하여 보급하였다. 3. 국가 농업유전자원은행의 주요 역할을 요약하면, 국내 보존유전자원을 체계적으로 관리하고 국제적 흐름에 대응할 수 있도록 하는 국가 농업유전자원의 종합관리가 첫 번째 역할이고, 두 번째는 국가 유전자원은행(Genebank) 사업으로 국내외로부터 현재 및 미래가치에 의한 유용한 유전자원의 다양성 확보, 확보한 유전자원의 증식 및 특성평가, 안전한 보존관리 및 분양서비스에 의한 활용이며, 세 번째는 유전자원 관련 기술개발 연구로서 다양성 분석, 종자수명 및 보존기술, 증식 및 특성평가 기술, 기능성 및 유용 유전자 이용을 위한 탐색기술 개발 연구 등이고, 네 번째는 국내외 협력체계를 구축하여 관련분야 및 국제적으로 대응하는 역할로서 국가를 대표하고 국격을 높이는 주요 기능을 하여야 한다. 4. 농업유전자원의 금후 활용전망을 살펴보면 경쟁력 있는 최고의 농산물 생산에 지속적으로 기여할 것이고, 안정적인 식량공급과 국민의 참살이 수요를 충족하는 기본자원으로 활용되며, 농촌환경 생태계를 건전하고 윤택하게 보존하는데 활용되고, 에너지, 신물질, 신소재 등 차세대 성장동력원 창출의 원천 자원이 될 것이다. The application and use of agricultural genetic resources have been reviewed since Korea was freed from the rule of Japanese imperialism in 1945. The whole changes that took place in the Korean agriculture, such as, characteristics of agriculture, application trends of genetic resources, roles of agricultural genebank, and future utilization perspectives of plant genetic resources were reviewed and summarized. The whole changes that took place in the Korean agriculture since the liberation from the Japanese rule were as follows. Before 1960s, Korean agriculture was a subsistence farming system with the landraces, introduction of foreign cultivars, and the beginning stage of domestic breedings. In 1960-1970s, the importance of genetic resources came up because the Korean government had to solve the national shortage of foods by developing and disseminating high-yielding cultivars such as 'tongil rice'. In 1980-1990s, four-season-long cultivation of horticultural products were reared and predominantly based on the public needs. Since 2000s, diverse varieties of genetic resources became more important because of the need to cultivate crops with healthy function and high nutritional value. Hence, the interest in the diversity of agricultural genetic resources increased. The Rural Development Administration (RDA) has designated 91 local sub-banks for managing the overall national agricultural genetic resources. RDA installed the seed bank that contain more than 500,000 accessions with high technologies to preserve plant germplasms. Currently, the RDA deposits approximately 160,000 accessions of seeds, and developed and disseminated 2,477 cultivars using these genetic resources. In summary, the major role of national agricultural genebank are as follows: 1) to manage national agricultural genetic resources. 2) to secure diverse genetic resources of current and future values, to conduct multiplication and characteristic assessment of genetic resources, and to utilize genetic resources through safe preservation and distribution service. 3) to conduct a variety of researches such as genetic diversity analyses, develop seed dormancy and preservation tools, assess seed characteristics and multiplication of seeds, develop technology to discover valuable resources using functional genes. 4) to raise the national status for preservation of agricultural genetic resources through international and domestic cooperation. Agricultural genetic resources will be used for the following purposes: to continuously produce competitive cultivars with high quality, to be utilized as raw materials to meet a constant food supply and demands of the general public's well-being, to be applied to make agri-ecosystem healthy and prosperous, and to be used as a driving force for new growth of industries related to energy, new materials and stuffs.

생물다양성협약과 유전자원 관련 지식재산권 논의와 쟁점

허인 강원대학교 비교법학연구소 2020 환경법과 정책 Vol.24 No.-

Genetic resources and its relation to the protection of intellectual property is a controversial issue which has been one of the agendas of TRIP regarding biological diversity for the last ten years. Most of the nations agree with the protection of genetic resources and related traditional knowledge but the issue is how to do so. In order to resolve this problem, WIPO IGC was established in 2000 and up until now, they are discussing issues including access and benefit sharing and matters over intellectual property rights regarding traditional knowledge and folklore. With the adoption of 「Convention on Biological Diversity(CBD)」 in 1992, balanced stance and practical approach method to genetic resources is defined as a binding regulation. This convention ensures conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources and sovereignty of countries on Genetic Resources. Facing the year 2010 the year which UN has declared to be the International Year of Biodiversity, has hosted 10th Conference of the Parties(COP) in Nagoya, Japan and adopted 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」. This is a historic event in the scene of Access and benefit-sharing(ABS) of biodiversity. The adoption of the ABS Protocol and the following new ABS standards are expected to influence the discussion of WIPO IGC and TRIPS Council. In the WIPO ICG conference and the discussion related to having PIC and MAT mandatory in relation to the TRIPS and CBD, considering relevant matters of the ABS in patent-related works will be discussed. However, it should be noted that the purpose of the Convention on Biological Diversity and ABS Protocol is to preserve the biological diversity through the ABS on genetic resources and related traditional knowledge, and to contribute to the sustainable use of its components while the objective of the discussion of WIPO IGC is to protect genetic resources and traditional knowledge or to preserve them as an intellectual property. In the conclusion, minimum standards which were required by global community on access to genetic resources and benefit sharing need to be set forward to ensure stable and long-term protection of domestic genetic resources and its utilization. In the field of genetic resources, there is a possibility that we would be able to solidify our status as a user nation due to the continuous development of the bio-industry which comes after the advancement of biotechnology. Therefore, we should take counter measures on separate issues considering the stance of user nations in global discussions relevant to the field of genetic resources and traditional knowledge. 유전자원의 무분별한 이용과 생태계 파괴, 환경오염 등으로 인하여 생물다양성은 급격히 감소하고 있는 반면, 분자생물학과 유전공학 등의 분야에서 기술이 발전함에 따라 유전자원에 대한 가치는 지속적으로 증가하고 있다. 이러한 이유로 세계 각국은 유전자원을 확보하기 위한 치열한 경쟁을 벌이고 있다. 유전자원을 이용할 수 있는 기술력을 가진 선진국들은 자원확보를 위한 노력과 함께 유전자원을 통해 산출된 산물에 대한 지식재산권의 강화를 주장하고 있는 반면, 다양한 생물유전자원을 보유한 개발도상국들은 자국의 유전자원 이용에 대한 이익의 공유를 주장하고 있어, 유전자원을 둘러싸고 선진국과 개발도상국 간의 첨예한 갈등과 분쟁이 증가하고 있다. 생물다양성협약이 생물유전자원의 접근과 이익공유를 중심으로 진행이 되었다면, WIPO IGC와 TRIPS 협정에서의 논의는 유전자원 출처공개의 특허요건화를 중심으로 진행되고 있다. 우리나라의 입장에서 유전자원 출처공개의 특허요건화는 출처공개에 따른 행정적 비용 및 출원인의 부담을 증가시켜 국내 생명공학 관련 연구를 위축시킬 수 있다는 견해가 지배적이다. 그러나 국제적 관계 속에서 개발도상국의 입장을 무시할 수는 없는 것이 사실이므로 국제적 동향을 예의주시하고 그 대응을 철저하게 준비할 필요가 있다.

한국 농업에서의 유전자원 활용 현황과 금후 전망

김창영 ( Chang Yung Kim ),이정란 ( Jeong Ran Lee ),윤문섭 ( Mun Sup Yoon ),조규택 ( Gyu Taek Cho ),백형진 ( Hyung Jin Baek ),고호철 ( Ho Cheol Ko ),조양희 ( Yang Hee Cho ),전영아 ( Young Ah Jeon ),김정곤 ( Chung Kon Kim ) 한국국제농업개발학회 2010 韓國國際農業開發學會誌 Vol.22 No.3

The application and use of agricultural genetic resources have been reviewed since Korea was freed from the rule of Japanese imperialism in 1945. The whole changes that took place in the Korean agriculture, such as, characteristics of agriculture, application trends of genetic resources, roles of agricultural genebank, and future utilization perspectives of plant genetic resources were reviewed and summarized. The whole changes that took place in the Korean agriculture since the liberation from the Japanese rule were as follows. Before 1960s, Korean agriculture was a subsistence farming system with the landraces, introduction of foreign cultivars, and the beginning stage of domestic breedings. In 1960-1970s, the importance of genetic resources came up because the Korean government had to solve the national shortage of foods by developing and disseminating high-yielding cultivars such as `tongil rice`. In 1980-1990s, four-season-long cultivation of horticultural products were reared and predominantly based on the public needs. Since 2000s, diverse varieties of genetic resources became more important because of the need to cultivate crops with healthy function and high nutritional value. Hence, the interest in the diversity of agricultural genetic resources increased. The Rural Development Administration (RDA) has designated 91 local sub-banks for managing the overall national agricultural genetic resources. RDA installed the seed bank that contain more than 500,000 accessions with high technologies to preserve plant germplasms. Currently, the RDA deposits approximately 160,000 accessions of seeds, and developed and disseminated 2,477 cultivars using these genetic resources. In summary, the major role of national agricultural genebank are as follows: 1) to manage national agricultural genetic resources. 2) to secure diverse genetic resources of current and future values, to conduct multiplication and characteristic assessment of genetic resources, and to utilize genetic resources through safe preservation and distribution service. 3) to conduct a variety of researches such as genetic diversity analyses, develop seed dormancy and preservation tools, assess seed characteristics and multiplication of seeds, develop technology to discover valuable resources using functional genes. 4) to raise the national status for preservation of agricultural genetic resources through international and domestic cooperation. Agricultural genetic resources will be used for the following purposes: to continuously produce competitive cultivars with high quality, to be utilized as raw materials to meet a constant food supply and demands of the general public`s well-being, to be applied to make agri-ecosystem healthy and prosperous, and to be used as a driving force for new growth of industries related to energy, new materials and stuffs.

신지식재산 분야 국제동향과 법적 대응에 관한 고찰 — 식물신품종과 유전자원을 중심으로 —

허인,심연주 한국경영법률학회 2013 經營法律 Vol.23 No.3

CBD and the discussions on the biological genetic resources The importance of genetic resources is growing with the economic value as the materials for bio-industries such as the development of new varieties and new medicine as well as with the value in the society, ecology, and bio-resources. On the other hand, each nation has been going under the fierce competition to acquire the bio-resources with rapid decrease of biological diversities. And the conflicts of interests is getting worse between the countries having the resources and the developed countries using the resources. The developed countries insist on the intellectual property rights to the results developed from the genetic resources which they are trying to acquire, and the developing countries which reserve genetic resources insist on the rights to share the benefits in the use of the nations' genetic resources. In this context, the international society has discussed various issues on genetic resources: CBD and ITPGRFA have tried to make regulations on the access and he utilization of other countries' resources; WIPO(World Intellectual Property Organization) has tries to gather intergovernmental opinions and to seek certain agreements on the issues of the intellectual property rights to genetic resources, traditional knowledge and folklore. These efforts, however, have not narrowed the gaps on opinions. International Treaty on Plant Genetic Resources for Food and Agriculture(ITPGRFA) and the recently-concluded Nagoya Protocol which has bounding forces, both of which, however, are still in unstable status. CBD explicitly states that the access to genetic resources shall be made under the mutually agreed terms(MAT) and the contract is the most general way to set the mutually agreed terms. 'The Panel of Experts on Access and Benefit Sharing' was established in 1999 following the discussion results from COP(Conference of Parties) of CBD. With reference to the reports of 'the Panel of Experts' , Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising Out of Their Utilization was drafted in 2001 and adopted in 2002 by the 6th COP. WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (the IGC) is undertaking the negotiations between the developed and developing countries about the issues on the benefit sharing and the disclosure requirements in patent applications that relate to genetic resources in a claimed invention. The developing countries having genetic resources such as Brazil and India insist that the disclosure requirement, prior informed consent, and benefit sharing should have legal binding power by the international treaties. On the other hand, the developed countries using the genetic resources such as USA and Japan oppose to the developing countries arguing the disclosure requirement can restrain the new research and development, suggesting to build database to protect genetic resources. Europe and the Switzerland have opinion to make the disclosure requirement formal in PCT and PLT. On 30 October 2010, the tenth Conference of Parties of Convention on Biological Diversity(the CBD) adopted the Nagoya Protocol on Access to Genetic Resources and Benefit-Sharing. Until now (2012.11) 92 countries including South Korea signed, 9 countries; India, Mexico, Ethiopia, Fiji, Laos, Gabon, Jordan, Rwanda, Seychelles Islands, ratified the protocol. The Nagoya Protocol is a legally binding instrument dedicated to ABS and the international community is now shifting its attention from negotiating a legally binding instrument to ensuring its entry into force and implementation. After the CBD in 1993, the objective of fair and equitable sharing of benefits arising from the utilization of genetic resources has been a big issue. To negotiate the international regime for ABS of genetic resources is a main mandate for in the past years and ABS becomes an inev...

생물유전자원에 대한 접근 및 이익의 공유

류병운 ( Lyou Byung-woon ) 홍익대학교 법학연구소 2017 홍익법학 Vol.18 No.2

1992년 `생물 다양성 협약(Convention on Biological Diversity: CBD)`는 유전자원의 활용 이익의 보다 공정하고 공평한 분배를 위하여 `유전자원 접근과 이용으로부터 발생하는 이익의 공유(Access to Genetic Resources and Benefit Sharing)`[이하 “ABS”]의 체계를 도입하였다. 그러나 CBD는 사전 통보된 동의, 공평한 이익의 공유, 상호 합의라는 이익 공유를 위한 3가지 원칙만을 제시하여 그에 대한 구체화가 필요한 상황이었다. 2010년 10월 ABS 체제의 구체화 및 투명하고 실질적인 이행을 위하여 나고야 의정서가 채택되었다. 이 나고야의정서는 2014년 10월 12일부터 발효되었고 한국도 비준절차를 마쳤다. 또한 동(同)의정서에 따른 최소한의 국내입법조치라고 할 수 있는 “유전자원 접근 및 이익 공유에 관한 법률”[이하 “유전자원법”]을 제정하였다. 한국은 상당히 많은 외국 유전자원을 사용하고 있는 국가이다. 따라서 한국에 대해서 적용되는 나고야의정서에 대한 보다 철저한 분석과 대응 전략의 수립과 보다 구체적이고 치밀한 국내 법적 제도의 도입과 합당한 정책개선을 모색하여야 한다. 한국의 유전자원법은 해외 유전자원에 대한 접근과 이용관련 내용이 매우 미흡하여, 향후 한국의 이익을 고려하고 보다 치밀하고 구체적인 내용으로 개정되어야 한다. 유전자원법 개정 방향과 관련하여 EU규칙이 “유전자원”에 파생물을 명시하지 않아 기존 선진국들의 입장을 취하고 있고 ABS의 대상을 나고야의정서 발효 후 취득된 유전자원에 한정하며 또한 새로운 개발에 근거한 후속적 적용 및 상업화의 경우를 ABS의 대상에서 제외하는 내용 등을 참고할 수 있다. 또한 나고야의정서의 ABS 체제를 뒷받침하기 위해서는 국내 특허 가능성 기준, 특히 동 식물과 유전자원의 발명에 대한 특허가능성 기준의 구체화 및 엄격화가 필요하다. 한국은 나고야의정서의 개정 추진 등 국제협상력 강화를 위해 노력하여야 한다. 나고야 의정서의 개정 방향은 동(同)의정서의 명확성과 구체성의 강화, 한국 이익의 반영, 국제 ABS분쟁해결기관의 설립으로 요약할 수 있다. 특히 WIPO협상에서 보호 대상 전통지식의 범위가 토착지역공동체 외에 민족이나 국가 보유의 전통지식으로 확대 정의되도록 노력하고, 그와 같은 WIPO의 정의로 ABS대상 전통지식의 정의를 통일시키는 방향으로 CBD와 나고야의정서의 개정이 추진되어야 한다. 나고야의정서의 ABS관련 분쟁의 통일적이고 효과적인 해결을 위해서는 다자적 분쟁해결기구 설립도 필요하다. 한국 정부는 국가적 차원에서 보유 유전자원을 발굴 탐색하여 특허 출원 등 관련 지식재산권을 확보하거나 그와 같은 노력을 지원해야 한다. 그러한 방법의 하나로 한국 지역사회에 속한 유전자원이나 관련 전통지식에 대해서는 특허 외에 `지리적 표시(geographical indication)`를 인정받는 방안도 추진해야 한다. The 1992 Convention on Biological Diversity(CBD) introduced “Access to Genetic Resources and Benefit Sharing(ABS)”system to secure more fair and just sharing of genetic resources benefit. However CBD only suggested three principles such as prior informed consent, fair and equitable benefit sharing, and mutually agreed terms, therefore, all these needed shaping up. In October 2010, Nagoya Protocol on Access to Genetic Resources and The Fair and Equitable Sharing of Benefits Arising from Their Utilization to The CBD [hereafter “Nagoya Protocol”] was adopted for shaping up the ABS system, increasing the transparency, strengthening implementation. In Korea, the Nagoya Protocol took effect from October 12^th of 2014. Also “Access to Genetic Resources and Benefit Sharing Law” [hereafter “Genetic Resource Law”], which seem minimum domestic legislative requirement of the protocol, was enacted in Korea in 2017. Korea uses lots of foreign origin genetic resources. Accordingly, Korea needs thorough analysis and counter strategy concerning Nagoya Protocol and introduces more concrete and detailed domestic legal system as well as finds a reasonable policies. The Genetic Resource Law of Korea is insufficient for the access and use of foreign genetic resources, therefore it needs to be revised into more elaborated and concrete contents in the consideration of future benefit to Korea. Regarding the revision, references can be available from the EU regulation, which supports the argument of the developed countries, excludes derivatives from “Genetic Resources”, limit objects of ABS to the genetic resources acquired after Nagoya Protocol becomes effective and rule follow-up application and commercialization based on new development out of the objects of ABS. Also, in order to support the ABS system, the more concrete and strict standards of patentability, particularly for genetic resources, should be applied in Korea. Korea should strive for the reinforcement of international bargaining power such as the amendment processing of Nagoya Protocol. The amendment direction of Nagoya Protocol could be summarized as reinforcing the clarity and concreteness of the Protocol, reflection of benefit to Korea and establishment of international ABS dispute settlement body. Especially the daft articles of “The Protection of Traditional Knowledge” of WIPO provides that “Traditional knowledge [refers to]/[includes]/[means], for the purposes of this instrument, know-how, skills, innovations, practices, teachings and learnings of [indigenous [peoples] and [local communities]]/[or a state or states]”. The draft articles enlarges the definition of traditional knowledge into any ethnic or national knowledge other than that held by indigenous and local communities. And following to the completed definition of WIPO, amendment of CBD and Nagoya Protocol should be carried forward to unify the definition of traditional knowledge of ABS. Korean government should obtain intellectual property like patent through excavation search of retentive genetic resources or needs to support those efforts in national level. As one of those efforts, a plan should be prosecuted that `geographical indication` gets recognized other than patent, regarding genetic resources or related traditional knowledge belonged to regional community in Korea.

나고야의정서의 이행에 따른 유전자원법의 법적 검토

김승래 ( Kim Seung Rae ) 한남대학교 과학기술법연구원 2020 과학기술법연구 Vol.26 No.1

생물유전자원의 중요성을 인식한 인류는 2010년 10월 29일 제10차 생물다양성협약(CBD) 당사국 총회에서 ‘유전자원에 대한 접근 및 유전자원의 이용으로부터 발생하는 이익의 공정하고 공평한 공유에 관한 나고야의정서’(ABS)를 채택하였다. 본 의정서는 2014년 10월 12일에 국제협약으로 발효되었다. 나고야의정서는 생물유전자원 나아가 생물자원과 관련이 있는 전통지식을 이용할 경우 해당 유전자원 제공 국가의 법률 등에 따라 사전 승인(PIC)을 받고 생물자원에서 취득한 이익에 대해서는 서로 합의된 조건(MAT)에 따라 공유하도록 하는 내용을 담은 법적 구속력이 있는 국제규범(Regime) 이다. 유전자원을 국가의 권리로 승인하는 데서 비롯된 유전자원을 밖으로 반출하는 것을 규제하고, 무차별적 남획 및 이용을 저해하는 등 이용국의 유전자원 보호 및 관리가 강화되는 효과를 기대할 수가 있다. 또한 나고야의 정서가 효력을 발생하는 전에는 유전자원을 이용하여 발생된 이익은 지식재산권을 포함하여 극대화 할 수 있었으나, 앞으로 본 의정서가 효력이 발생된 이후에는 유전자원을 공여한 국가 및 제공한 자에게 이익의 공유를 인정하여야 하므로 제한적일 수가 있게 되었다. 우리나라는 2011. 9. 20.에 나고야의정서에 서명하였고, 2017. 5. 19.에 비준하였다. 이에 따라 2017. 1. 17. 나고야의정서의 국내이행법인 ‘유전자원의 접근ㆍ이용 및 이익 공유에 관한 법률’(이하 유전자원법‘이라 함)을 제정 하였으며, 동 법률은 2017. 8. 17. 발효되었다. 이로써 우리나라는 나고야의 정서의 98번째 당사국의 지위를 확보했다. 그러나 나고야의정서의 이행법으로 유전자원법이 제정ㆍ시행되고 있음에도 자국의 생물자원에 대한 주권을 강화하려는 국제적인 추세에 대응하기 위하여 보다 정교한 법제도의 구축이 시급한 시점이다. 이 논문은 나고야의정서의 국내 이행법으로 제정된 유전자원법에 대한 법적 검토를 위하여 나고야의정서의 채택배경을 살펴보았고, 나고야의정서의 주요내용을 검토하였으며, 우리 유전자원법의 입법과정과 법의 주요내용 및 향후 개정방향을 제시하였다. 유전자원법의 문제점을 제한된 범위 내에서 몇 가지로 검토한 것에 그치고, 아직 유전자원법이 시행된 지 얼마 되지 아니하여 법 시행에 따른 문제점을 분석하여 향후 입법에 반영하는 것은 차후 연구과제로 미루어 놓았다고 해도 과언이 아니다. 결론적으로 생물자원의 해외 의존도가 높은 우리나라로서는 유전자원을 활용하는 관계 산업부문(바이오, 농산물종자, 뷰티산업, 한의약업 등)과 생물자원 연구분야에 미치는 영향이 지대할 것으로 예상되며 그에 대한 법률분쟁에 기한 사후적 피해에 철저한 대비가 유전자원법의 검토를 통하여 규명되어야 할 것이다. Recognizing the importance of biological gene sources, humanity, at the 10th Congress of the Convention on Biological Diversity(CBD) on October 29, 2010, stated that 'the fair and equitable sharing of benefits arising from access to genetic resources and the use of genetic resources Adopted the Nagoya Protocol(ABS). This Protocol came into force on 12 October 2014 as an international agreement. The Nagoya Protocol requires that prior knowledge of biological genetic resources and biological resources be used to obtain prior approval(PIC) in accordance with the laws of the country of origin of the genetic resources, and to share the benefits generated therefrom under mutually agreed terms(MAT). It is a legally binding International Regime. Recognizing genetic resources as a national right can enhance the protection and management of their genetic resources by regulating the external export of genetic resources and preventing indiscriminate overuse and use. In addition, before the Nagoya Protocol came into effect, profits generated by using genetic resources could be maximized, including intellectual property rights. It became possible. Korea signed the Nagoya Protocol on September 20, 2011 and ratified it on May 19, 2017. As a result, on January 17, 2017, the Nagoya Protocol enacted the Act on Accessing, Using and Sharing Benefits of Genetic Resources(hereinafter referred to as the Genetic Resources Act), which came into force on August 17, 2017.It became. This secured the status of the 98th Party of the Nagoya Protocol. However, despite the enactment and enforcement of the genetic resources law as a law to implement the Nagoya Protocol, it is time to build a more sophisticated legal system to cope with the international trend to strengthen sovereignty over biological resources. This paper examines the background of the adoption of the Nagoya Protocol for legal review of the genetic resources law enacted as the domestic implementation law of the Nagoya Protocol, reviewed the main contents of the Nagoya Protocol, and reviewed the legislative process and main contents of the Law. The direction of future revision is presented. Although the problems of the genetic method have been examined in a limited manner, it is not too long since the genetic method has been put into effect, and it is an exaggeration to say that the analysis of the problems caused by the law is reflected in future legislation. This is not it. In conclusion, Korea, which has high dependence on biological resources abroad, is expected to have a great impact on related industrial sectors(bio, agricultural seed, beauty industry, oriental medicine, etc.) and biological resource research fields that utilize genetic resources. Thorough preparations for ex post damages should be identified through a review of the genetic method.

세계지식재산기구 정부간위원회의 유전자원 및 연관 전통지식 관련 지식재산권 협상쟁점과 나고야의정서에 대한 시사점

박원석,이선빈 중앙법학회 2022 中央法學 Vol.24 No.4

Despite its ongoing negotiation status, the IGC Chair’s A mended Draft(hereinafter, the Chair’s Draft) could make a great contribution to the practical implementation of the intellectual property-related issues under Nagoya Protocol. Especially, The definitions which have not previously been defined at the multilateral level, source of genetic resources, and source of traditional knowledge associated with genetic resources materially/directly based on may make a great contribution to enhance the legal certainty and clarity. The IGC Chair’s Draft defines the source of genetic resources as referring to any source from which the applicant has obtained the genetic resources, such as the country of origin, indigenous peoples and local communities, a research centre, gene bank, the Multilateral System of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), or any other ex situ collection or depository of genetic resources, which is expected to provide the limited scope of their source. This Draft also defines the “Source of Traditional Knowledge Associated with Genetic Resources” as meaning any source from which the applicant has obtained the traditiona l k nowledge associated with genetic resources, such as indigenous peoples or local communities, scientific literature, publicly accessible databases, patent applications and patent publications, which indicates that there could be other source of traditional knowledge of genetic resources in addition to IPLC. The “materially/directly based on” specifies the particular relationship between the claimed invention and the genetic resources and Associated Traditional knowledge which activates the obligation to disclose (referred to in the IGC discussions as the “trigger”), and provides important guidance and direction to the patent applicant as well as patent offices. The definition of “[materially/directly] based on” is found in Article 2 of the Chair’s Draft, which reads “[Materially/Directly] based on” means that the genetic resources and/or Associated traditional knowledge must have been necessary or material to the development of the claimed invention, and that the claimed invention must depend on the specific properties of the genetic resources and/or Associated traditional knowledge, and reveals its quite strict “disclosure requirement. Therefore, this definition clarifies the causal relationship between the claimed invention and genetic resou rces and/or Associated traditiona l k nowledge which must be necessary or material to the claimed invention, not to the development of the claimed invention. What could most attract the attention of patent applicant and patent offices wil l be related to the provisions regarding the limitations and sanctions for the non-compliance with disclosure requirement obligations. The Draft requires each Contracting Party to put in place appropriate, effective and proportionate legal, administrative, and/ or policy measures to address an applicant’s failure to disclose the information specified in disclosure requirement clause. However, it leaves to the national patent offices what constitutes appropriate, ef fec tive a nd propor tionate lega l, a d m i n is t rative, a nd/or pol ic y measures. These measures could include pre-grant sanctions, such as suspending the further processing of a patent application until the disclosure requirement is satisfied, or withdrawing/lapsing the application if the applicant fails or refuses to provide the information specified in the disclosure requirement clause within a time period as determined at the national level. These measures could also contain post-grant sanctions, such as fines for wilfully failing to disclose the specified information or intentionally providing incorrect information as well as the publication of judicial rulings. In addition, the Draft requires each Contracting Party to provide an applicant an opportunity to rect...

연구논문 : 사회과학 ; 식물유전자원에 대한 접근 및 이익공유(ABS)에 관한 국제쟁점 동향과 시사점

이호선 ( Ho Sun Lee ),이석영 ( Sok Young Lee ),백형진 ( Hyung Jin Baek ),정응기 ( Eung Gi Jeong ),김정곤 ( Chung Kon Kim ),김연규 ( Yeon Gyu Kim ) 한국국제농업개발학회 2012 韓國國際農業開發學會誌 Vol.24 No.2

식물유전자원에 대한 접근과 이익공유(Access to genetic resources and Benefit Sharing: ABS)에 대한 국제규범은 식량농업식물 유전자원국제조약(International Treaty on Plant Genetic Resources for Food and Agriculture: ITPGRFA)과 생 물다양성협약(Convention on Biological Diversity: CBD) ABS의정서(일명 ``나고야의정서``)가 있는데, 그 목적에 따라 다른 체제를 가지고 있다. ITPGRFA는 지속적 농업발전과 식량안보에 기여하는 식량 및 사료작물 64작물에 대해 다자체제를 적용한다. 유전자원에 대한 접근과 유전자원을 이용한 후 발생하는 이익에 대해서는 유전자원 제공자와 수령자 사이에 표준물질이전협정(Standard Material Transfer Agreement: SMTA) 체결에 의해 이루어질 수 있다. 상업적 이익이 발생하였을 때는 체결한 표준물질이전협정에 따라 수익의 일정 부분을 식량농업식물 유전자원국제조약 재정기구에 납부해야 한다. 그렇게 지불된 자금은 개발도상국과 경제체제전환국의 농부들에게 직·간접적으로 지원하는데 사용된다. CBD ABS의정서는 ITPGRFA의 다자체제와는 다른 자원제공자(혹은 제공국)와 이용자(혹은 이용 국)간의 양자체결에 의해서 이루어진다. 생물유전자원뿐만 아니라 이와 관련된 전통지식을 포함하여 이용을 위해 접근 할 경우 사전에 자원제공국이나 제공자에게 허가를 받아야 하며 (사전통보승인, Prior Informed Consent, PIC), 유전자원의 이용에서 발생하는 이익을 자원제공자와 이용자간 상호합의조건 (Mutually Agreed Terms, MAT)에 따라 공유하도록 규정한다. 이러한 절차나 내용은 각국의 법으로 규정하도록 되어 있다. 또한 ABS의정서는 PIC나 MAT와 같은 절차의 이행여부를 모니터링 하고, 그와 관련된 내용을 ABS 정보공유소(ABS Clearing House)에 등록하도록 되어있다. 이러한 ABS 국제규범으로 인하여 유전자원에 대한 국가의 주권의식이 높아지고 자국의 유전자원의 보호와 관리가 강화됨에 따라 국내 유전자 원의 다양성 확보와 보존 및 활용을 위해 국제동향에 맞추어 능동적으로 준비하는 것이 필요하다. Access to plant genetic resources and the fair and equitable sharing of benefit arising from their utilization (ABS), together with conservation and sustainable use, are the heart of both the Convention on Biological Diversity (CBD) ABS Protocol (hereinafter "Nagoya protocol") and the International Treaty on Plant Genetic Resources for Food and Agriculture, (ITPGRFA). The ITPGRFA established a Multilateral System of ABS for those plant genetic resources that are most important for security and on which countries are most interdependent. For such 64 crops, which are listed in Annex of the ITPGRFA, the Contracting Parties have agreed on standard terms and conditions that will govern their transfer for the purpose of research, breeding and training. These standard terms and conditions are set out in the SMTA (Standard Material Transfer Agreement). The financial benefits arising from commercialization form part of the Funding Strategy under Article 18 of the ITPGRFA. An essential element of the Strategy is the direct or indirect support for biodiversity conservation and in particular for the long-term ex situ conservation and availability of PGRFA. The Nagoya Protocol is an international agreement aimed at ensuring the fair and equitable sharing of benefits from the use of genetic resources that contribute to biodiversity. The Nagoya Protocol seeks to further implement the Convention`s provisions governing access to genetic resources and the fair and equitable sharing of benefits arising out of the utilization of such resources. The Nagoya Protocol calls upon each nation to establish clear rules and procedures requiring for genetic resources users to obtain prior informed consent before accessing a country`s genetic resources. The Nagoya Protocol also reinforces the authority of each country to the users to enter into benefit-sharing agreements, based on mutually agreed terms (MAT), stemming from the use of such resources. To support compliance of ABS, each party shall take to monitor and to enhance transparency about the utilization of genetic resources. Such measures shall include the designation of checkpoints to monitor the implementation of MAT and the establishment of ABS Clearing House as a means for sharing of information related to access and benefit sharing. The international agreements relevant to ABS recognize the sovereign rights of nations over the genetic resources and strengthen in the conservation and management of their own genetic resources. For securing of domestic diversity of genetic resources and utilization of them, it is necessary to prepare actively in accordance with international issues.

식물유전자원에 대한 접근 및 이익공유(ABS)에 관한 국제쟁점 동향과 시사점

이호선,이석영,백형진,정응기,김정곤,김연규 한국국제농업개발학회 2012 韓國國際農業開發學會誌 Vol.24 No.2

식물유전자원에 대한 접근과 이익공유(Access to genetic resources and Benefit Sharing : ABS)에 대한 국제규범은 식량농업식물유전자원국제조약(International Treaty on Plant Genetic Resources for Food and Agriculture : ITPGRFA)과 생물다양성협약(Convention on Biological Diversity : CBD) ABS 의정서(일명 ‘나고야의정서’)가 있는데, 그 목적에 따라 다른체제를 가지고 있다. ITPGRFA는 지속적 농업발전과 식량안보에 기여하는 식량 및 사료작물 64작물에 대해 다자체제를적용한다. 유전자원에 대한 접근과 유전자원을 이용한 후 발생하는 이익에 대해서는 유전자원 제공자와 수령자 사이에 표준물질이전협정(Standard Material Transfer Agreement :SMTA) 체결에 의해 이루어질 수 있다. 상업적 이익이 발생하였을 때는체결한 표준물질이전협정에 따라 수익의 일정 부분을 식량농업식물유전자원국제조약 재정기구에 납부해야한다. 그렇게 지불된 자금은 개발도상국과 경제체제전환국의 농부들에게 직·간접적으로 지원하는데 사용된다. CBD ABS의정서는 ITPGRFA의다자체제와는 다른 자원제공자(혹은 제공국)와 이용자(혹은 이용국)간의 양자체결에 의해서 이루어진다. 생물유전자원 뿐만 아니라 이와 관련된 전통지식을 포함하여 이용을 위해 접근 할경우 사전에 자원제공국이나 제공자에게 허가를 받아야 하며(사전통보승인, Prior Informed Consent, PIC), 유전자원의 이용에서 발생하는 이익을 자원제공자와 이용자간 상호합의조건 (Mutually Agreed Terms, MAT)에 따라 공유하도록 규정한다. 이러한 절차나 내용은 각국의 법으로 규정하도록 되어 있다. 또한 ABS의정서는 PIC나 MAT와 같은 절차의 이행여부를 모니터링 하고, 그와 관련된 내용을 ABS 정보공유소(ABS Clearing House)에 등록하도록 되어있다. 이러한 ABS 국제규범으로 인하여 유전자원에 대한 국가의 주권의식이 높아지고자국의 유전자원의 보호와 관리가 강화됨에 따라 국내 유전자원의 다양성 확보와 보존 및 활용을 위해 국제동향에 맞추어능동적으로 준비하는 것이 필요하다. Access to plant genetic resources and the fair and equitable sharing of benefit arising from their utilization (ABS), together with conservation and sustainable use, are the heart of both the Convention on Biological Diversity (CBD) ABS Protocol (hereinafter “Nagoya protocol”) and the International Treaty on Plant Genetic Resources for Food and Agriculture, (ITPGRFA). The ITPGRFA established a Multilateral System of ABS for those plant genetic resources that are most important for security and on which countries are most interdependent. For such 64 crops, which are listed in Annex of the ITPGRFA, the Contracting Parties have agreed on standard terms and conditions that will govern their transfer for the purpose of research, breeding and training. These standard terms and conditions are set out in the SMTA (Standard Material Transfer Agreement). The financial benefits arising from commercialization form part of the Funding Strategy under Article 18 of the ITPGRFA. An essential element of the Strategy is the direct or indirect support for biodiversity conservation and in particular for the long-term ex situ conservation and availability of PGRFA. The Nagoya Protocol is an international agreement aimed at ensuring the fair and equitable sharing of benefits from the use of genetic resources that contribute to biodiversity. The Nagoya Protocol seeks to further implement the Convention’s provisions governing access to genetic resources and the fair and equitable sharing of benefits arising out of the utilization of such resources. The Nagoya Protocol calls upon each nation to establish clear rules and procedures requiring for genetic resources users to obtain prior informed consent before accessing a country’s genetic resources. The Nagoya Protocol also reinforces the authority of each country to the users to enter into benefit-sharing agreements, based on mutually agreed terms(MAT), stemming from the use of such resources. To support compliance of ABS, each party shall take to monitor and to enhance transparency about the utilization of genetic resources. Such measures shall include the designation of checkpoints to monitor the implementation of MAT and the establishment of ABS Clearing House as a means for sharing of information related to access and benefit sharing. The international agreements relevant to ABS recognize the sovereign rights of nations over the genetic resources and strengthen in the conservation and management of their own genetic resources. For securing of domestic diversity of genetic resources and utilization of them, it is necessary to prepare actively in accordance with international issues.