До питання правового регулювання ризиків діяльності у галузі генної інженерії

І. В. Горіславська, А. І. Клименко

Анотація


TO THE QUESTION OF LEGAL REGULATION OF OPERATIONAL RISKS IN THE FIELD OF GENETIC ENGINEERING

I. V. HORISLAVSKA, Candidate of Law, Assistant Professor

National University of Life and Environmental Sciences of Ukraine

A. I. KLYMENKO, 3rd year student of Law Faculty

National University of Life and Environmental Sciences of Ukraine

 

Executive state function, the content of which is the management of society as a whole, is also in the management of certain areas and sectors of public life, including the risks in the field of genetic engineering.

Current status of administrative and civil law is characterized by increased interest of society and the state (including jurisprudence, law-making and judicial practice) to scientific studies on the search for new conceptual solutions that are aimed at solving urgent problems of individual sectors in particular, and the right to general.

According to some scientists, promising areas are called to play an important part in study of the principle of moderation between the constraints and the objectives and purpose of law, legal risk in various areas of law, because the category of «risk» inherent in every sphere of human activity and the enforcement of law and related trusts' its associated property management agreement of other alternative legal structures in which there are «variations in structure, content rights, the nature of the legal relationship, other elements» relations. One of the factors of legal basis for the existence of legal anomalies is a category of legal risk, risky transactions and risk obligations. Thus, a legal anomaly is defined as «deviation from the general pattern of normal development of social relations due to various factors – objective and subjective».

Legal risk is included in the conditions of civil liability or professional possibility of legal fact which may come or not come, the result of which will be three economic outcomes: negative, zero and positive.

Modern trends in legal risk are reflected in risky transaction, which is the basis of risk, which includes the obligation of innovation risk, including the risk of activities in the field of genetic engineering. These innovative risks are defined as the probability of failure to obtain certain results during execution using only the organizational, technical and scientific potential of.

An activity in the field of genetic engineering, such as the use of biotechnology in agriculture is a set of relations of production by genetic engineering and application of biotechnological origin of products in this area. The legal basis for the formation mechanisms of legal regulation of relations in the field of biotechnology in agriculture, especially a provision of the Convention on Biological Diversity in 1992, which defines the sovereign right of each country to access to genetic resources on the basis of national legislation.

Activity in the field of genetic engineering is a risky, while the literature draws attention to the lack of a unified approach to the basic criteria for risk analysis of agricultural biotechnology activities.

The main obstacle in this and in the coordination of international standards in the field of biotechnology lies in the complexity of coordination opposite positions and domestic legislative practices of the two most influential subjects of international law – the U.S. and the EU – such key issues as the concept of reasonable equivalence and the principle of precaution, the introduction of compulsory or voluntary labeling of genetically modified organisms (hereinafter – GMO), determination of the legal status of the human embryo, the introduction of «focused» or «multilateral» approach to human cloning and identification of forms of the genetic material , which ment to be protected by means of intellectual property rights.

International legal regulation of agricultural biotechnology is based on the following principles: conducting scientifically sound and consistent risk analysis, that these biotechnologies can cause to human health and the environment, establishing State responsibility regarding transboundary movements of GMOs, enforcement of fair and non-discriminatory trade in transgenic products, consideration of the interests of the indigenous population of the least developed countries on the use of the world's genetic resources.

Nowdays, Ukraine creates biosafety system, which aims to provide safe proceeding of genetic engineering and genetically modified organisms, and prevents their unauthorized and uncontrolled spread.

According to the State Environmental Policy Strategy of Ukraine till 2020 (hereinafter – the Strategy), to control the importation of genetically modified organisms into the territory of Ukraine, preventing their uncontrolled spread and improvement in 2015 permitting system in the treatment of genetically modified organisms, including their cross-border movements and coordination of genetic engineering relies on the Ministry of Ecology and Natural Resources of Ukraine, which is the central body of executive power in the formulation and implementation of national policy in the field of environmental protection, including genetic safety.

The first phase of the Strategy includes: development of legal acts on state regulation and control in the management of genetically modified organisms, genetic engineering activities, improvement of the licensing system in the treatment of genetically modified organisms, including their cross-border movements and coordination of genetic engineering.

The State Intellectual Property protects international and national patents and other intellectual property rights in the treatment of GMOs, and genetic engineering; Ministry of Education and Science of Ukraine defines the criteria of safety of GMOs and genetic engineering in closed systems, develops and improves the monitoring system of genetically engineering activities safety and implements other authorities, the Ministry of Ecology and Natural Resources of Ukraine carries out state ecological expertise of GMOs intended for use in an open system, the state registration of plant protection obtained using GMOs, permits the release of GMOs into the open system and is based on the principles of necessity, non-discrimination, proportionality and objectivity.

Посилання


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