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The article analyzes the topical issues of international legal regulation of genetic research; it provides a comparative analysis of two groups of international acts regulating relations related to genetic research and application of their results on creation, use and circulation of genetically modified organisms (except humans), on the study of human genome and application of their results. The article deals with the issues of objects and methods of genetic research regulation, balance of interests as the basis for legal regulation of public relations in the field of genomic research. It also considers approaches to ensuring a balance of private, group and common (public) interests. Criticism of certain provisions of the Convention on Human Rights and Biomedicine is given, the question of the inadmissibility of legal opposition between the protection of human rights and the interests of science and society as a whole is raised. The authors put forward proposals on the implementation of a number of international norms in Russian legislation and its further improvement, as well as on the use of blockchain technology in genetic research.

The primary international forum deliberating the regulation of “synthetic biology” is the Convention on Biological Diversity (CBD), along with its subsidiary agreements concerned with the biosafety of living modified organisms (LMOs; Cartagena Protocol on Biosafety to the CBD), and access and benefit sharing in relation to genetic resources (Nagoya Protocol to the CBD). This discussion has been underway for almost ten years under the CBD agenda items of “synthetic biology” and “new and emerging issues relating to the conservation and sustainable use of biological diversity”, and more recently within the scope of Cartagena Protocol topics including risk assessment and risk management, and “digital sequence information” jointly with the Nagoya Protocol. There is no internationally accepted definition of “synthetic biology”, with it used as an umbrella term in this forum to capture “new” biotechnologies and “new” applications of established biotechnologies, whether actual or conceptual. The CBD debates are characterized by polarized views on the adequacy of existing regulatory mechanisms for “new” types of LMOs, including the scope of the current regulatory frameworks, and procedures and tools for risk assessment and risk mitigation and/or management. This paper provides an overview of international developments in biotechnology regulation, including the application of the Cartagena Protocol and relevant policy developments, and reviews the development of the synthetic biology debate under the CBD and its Protocols, including the major issues expected in the lead up to and during the 2020 Biodiversity Conference.

Uno de los mayores retos que afronta la humanidad en este siglo es el de lograr un crecimiento económico mundial sostenido que garantice la protección y conservación del medio ambiente y la seguridad alimentaria para las generaciones futuras. Los problemas ambientales han dejado de ser un campo de construcción teórico, para convertirse en un referente de fenómeno real perceptible por sectores que resultan afectados en diversos intereses. El comercio de alimentos seguros y saludables es esencial tanto para empresarios como para autoridades y consumidores en todo el mundo. En la elaboración de las políticas alimentarias los Estados deben asegurar un nivel de protección de la salud y vida de las personas, además de los intereses sociales y económicos, ya sea a nivel internacional o nacional. En este artículo se analiza la función del principio de precaución en el ámbito de la diversidad biológica, poniendo especial énfasis en la regulación de los organismos vivos modificados One of the greatest challenges facing humanity in this century is to achieve sustained world economic growth in a way that ensures protection and conservation of the environment and food security for future generations. Environmental problems have ceased to be a theoretical field in the making and have become a benchmark for real phenomena perceptible by sectors whose various interests are affected. Commerce in safe and healthy food is essential for entrepreneurs, authorities and consumers worldwide. In drafting policies on food, countries must ensure a level of protection for people's health and lives, in addition to safeguarding social and economic interests, whether at the international or national level. In this article, the authors analyze the role of the precautionary principle in the field of biological diversity, with a special emphasis on the regulation of living modified organisms Um dos maiores desafios que a humanidade enfrenta neste século é o de conseguir um crescimento econômico mundial sustentável que garanta a proteção e a conservação do meio ambiente e a segurança alimentar para as gerações futuras. Os problemas ambientais têm deixado de ser um campo de construção teórico para se converter num referente de fenômeno real perceptível por setores que são afetados em diversos interesses. O comércio de alimentos seguros e saudáveis é essencial tanto para empresários quanto para autoridades e consumidores no mundo inteiro. Na elaboração das políticas alimentares, os Estados devem garantir um nível de proteção da saúde e da vida das pessoas, além dos interesses sociais e econômicos, seja no âmbito nacional, seja no internacional. Neste artigo, analisa-se a função do princípio de precaução no âmbito da diversidade biológica, enfatizando a regulação dos organismos vivos modificados

基因改造作物對於糧食安全以及生態環境的影響與衝擊目前係一尚無定論的議題。以生物多樣性資源的保育為出發點的「生物安全議定書」（以下簡稱議定書），希望透過事前告知同意程序的制度設計，替締約國在初次引進改性活生物體時，有一套可以依循的程序規範；在相同的國際管制帄台上，為預防外來種所造成對於一國環境生態的衝擊，WTO 也授權各國，依據「食品安全檢驗與動植物防疫檢疫措施協定」（SPS 協定）的規定，可以透過動植物檢疫措施的制訂以保護國內的生態系。兩套的進口管制制度是否相容，牽涉到國際環境公約與WTO 之間的關係與互動的議題，對於一國國內的生態環境以及生物科技發展也有其關聯性，因此，引起不少學者以及實務工作者的討論。本文將嘗詴著由程序面的觀察，討論在進口管制的程序上，比較議定書以及SPS 協定中的程序規範，找出是否可以透過進口管制程序的程序設計來避免兩套管制體系的衝突。此外，由於台灣並非生物安全議定書的締約國，依據議定書的規定，締約國得與非締約國針對改性活生物體的跨境運輸簽訂雙邊、區域性或是多邊的協定，本文也將針對議定書中此一規定，討論台灣在面對談判此等協定時，應採取的立場。 The impact of genetically modified crops on food supply security and on the environment has been an on-going debate. From the viewpoint of biodiversity conservation, the Biosafety Protocol provides procedural-based rules to regulate the first transboundary movement of living modified organisms (LMOs) through a set of advanced informed agreement (AIA) procedures. On the other hand, the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) of the World Trade Organisation (WTO) authorizes its Member to promulgate sanitary and phytosanitary measures to protect the domestic environment. The compatibility of these two sets of import control procedures hinges on the relationship between international environmental agreement and the WTO. The level of import control is also related to how a government plans to balance the interests of protecting its domestic environment and promoting the development of biotechnology. All these issues are highly controversial and attracted keen debate amongst scholars and practitioners. This paper will focus on the procedural design of these two sets of import control system and seek to avoid potential conflict between these two regimes by proposing a set of procedures that can meet the requirements under these two regimes. Meanwhile, the Biosafety Protocol authorizes Parties to conclude bilateral, regional or multilateral agreements with non-Parties concerning the transboundary movement of LMOs. Taiwan is not a Party to the Protocol. This paper, thus, will discuss possible strategies Taiwan may adopt when facing such negotiation.

Meeting the food needs of the world’s growing population while reducing poverty and protecting the environment is a major global challenge. Genetically modified crops appear to provide a promising option to deal with this challenge. However there is a need to make strategic decisions on how to spend limited agricultural research funds in order to achieve a maximum impact with regard to finding sustainable solutions to end hunger and poverty. In international development institutions, there is growing interest in the potential use of Strategic Environmental Assessment (SEA) as part of a research based Environmental Management System (EMS) to promote mainstreaming of environmental considerations in policy development. SEA was developed as an approach to integrate environmental considerations at a policy level, where alternatives environmental policies can be evaluated. In this paper, we propose using SEA in a policy research and priority setting process regarding new technologies, taking the development of Genetically Modified Organisms (GMOs) as an example. We propose that this method would be a useful tool for the international agricultural research centers of the Consultative Group for International Agricultural Research (CGIAR), streamlining business processes, strengthening accountability, sharpening the research agenda it supports, fostering broader partnerships, and increasing the relevance and impact of CGIAR research in achieving international development goals. Currently international law requires only Environmental Impact Assessments (EIAs) of specific biotechnology projects. The incorporation of environmental considerations only at the level of specific projects precludes the adoption of alternative environmental policies. In this review, we outline an SEA approach currently being considered at the International Food Policy Research Institute (IFPRI) for use in evaluating biotechnology policies. SEA may be a useful tool to inform the evaluation of biotechnology policies and priorities by taking account of information on the economic, social, and environmental benefits, cost and risks of adopting those policies.