Lex Genetica: Questions of Theory and Philosophy
The intertwining of technological manipulations of the human genome with other contemporary developments in biological science, medicine and law results in the need for adequate legal regulation of these areas. The article considers the development of legal relations in genomics within a humanistic biosocial and political-legal framework. Genomic legal relations are shown to gradually acquire a norm-referenced nature inherent in the present stage of biosocial development. Important current questions in humanistic thought include freedom of choice, protection of human dignity, and the development of awareness in the use of modern medical achievements. Due to the need to consider biomedical technologies, including cloning, the use of stem cells, euthanasia, and genetic profile of a person, contemporary biojurisprudence is fast becoming a cutting-edge field in the development of legal understanding.
Lex Genetica: Public -Law Dimension
The need to include specialized norms of modern Russian law in legislation governing the manufacture of medical devices from human biological material is considered on the example of normative legal acts regulating relations. A retrospective analysis of the development of legal regulation in the field of the use of human biomaterial in medicine, reveals the origins of the discussed issue. Current legislation in the Russian Federation in the field of organ and tissue donation for the purposes of transplantation and the use of human biological material for the production of medical devices is examined taking a specialized legal approach. A current lack of legal regulation in this area is revealed. While some issues associated with the use of human biomaterial for the manufacture of medical devices are fixed at the level of by-laws, the production of medical devices and biofabricated products is hindered by a lack of legal regulation in these areas of contemporary medicine. Required improvements in the legal foundations of regenerative and reconstructive medicine in the Russian Federation will involve the development of an independent federal law that includes norms and definitions for delimiting the provisions of regenerative and reconstructive medicine in related fields of medicine. As well as distinguishing between basic concepts in the fields of replacement-, regenerative- and reconstructive medicine, the definitions of these concepts must be consolidated in normative legal acts. Proposed definitions related to medical technologies and the use of human biomaterial are presented in the form of a new terminological glossary of innovative technologies involving the use of human biological material.
The current state of the legal support of food security in Russia is examined from the perspective of genetics and genomics. From a comparison of conventional and legal ideas about food security, priorities are identified and foundational principles analyzed. In contrast to earlier periods, the topic of food independence as a component of food security has received higher priority in more recent legal acts. As part of a balanced approach to prohibitions, permissions, and the imposition of controls in food security in the Russian Federation, the development of national genetic and genomic technologies should be taken into account. Future prospects for the development of food security legislation in the Russian Federation are considered. A proposition to legally formalize the principles of state policy at the level of the federal law is presented.
Lex Genetica: Private-Law Dimension
The legal regulation of relations concerning genomic information has undergone several transformations over recent years in the Russian Federation. Not only is a universal approach towards the regulation of such relations in civil law, including regarding the possibility of sharing such information, currently lacking, the concept of genomic information remains poorly defined as an object of civil rights. A special legal regime for big genomic data capable of processing with the help of artificial intelligence technologies is also lacking in the current legislation of the Russian Federation. Considering the great potential value of genomic data for all of humanity, and the need for the sharing of such data, a proposed balanced approach will ensure the sharing of genomic data with proper protection of personal non-propertyand other rights. Thus, the present work sets out to identify the specific features of genomic data sharing. When determining the civil legal regime for genomic information and genomic data, a balance between public and private interests can be ensured by maintaining personal non-property rights, ensuring the confidentiality of personal data, and obtaining consent for the dissemination of information in accordance with the law. However, in order to do this, it is necessary to distinguish conceptually between genomic information about a particular person and the genomic data on the basis of which such genomic information is obtained. The civil legal status of human biological material should be determined along with regulations for its processing to obtain genomic information at the same time as defining the legal regime for regulating biobanks in which such human biological material can be stored.
Lex Genetica: Comparative Legal Analysis
The protection of agricultural genetic resources, which represents a core element in the agricultural intellectual property (IP) system, will play an important role in realizing China's Rural Revitalization Strategy. In order to substantiate the need for improved agricultural property protection in China, the article examines existing issues in this area, including a weak understanding of IP protection on the part of rural people, imperfections in the existing legal framework, a lack of creative personnel working in the IP, inadequate support from government and other departments, as well as a lacking innovation mindset on the part of entrepreneurs. Proposed approaches for improving the legal awareness of agricultural genetic resource protection include increasing professional competencies in the aforementioned area and ensuring the participation of rural people in the protection of their agricultural genetic resources.
This article presents a detailed analysis of global and regional regulation related to the creation, use, research and conservation of biological (bioresource) collections and discusses the main trends in its development. Key approaches to the regulation of activities in the field of biological (bioresource) collections based on an analysis of acts of the European Union (EU), Organization for Economic Cooperation and Development (OECD), Commonwealth of Independent States (CIS), Eurasian Economic Union (EAEU) are identified. While there are no international treaties that deal directly with biological (bioresource) collections at the global level, various agreements in force cover important regulatory aspects concerning the creation, use, research and conservation of biological (bioresource) collections. These aspects include (1) providing access to genetic resources; (2) technology transfer and rights over such resources and technologies; (3) financial aspects; (4) standards for the conservation of genetic resources. The corresponding international treaties concluded at global and regional levels imply both integrated and sectoral approaches to the regulation of biological (bioresource) collections (e.g., international treaties regarding crop genetic resources). The conclusion highlights the need to take into account the approaches elaborated within the framework of international and regional integration law in order to improve the relevant legal regulation in the Russian Federation.
Event Digest
ISSN 3034-1647 (Online)