On improving the regulatory and legal regulation of biological safety in Ukraine

The paper examines the issues associated with developing national legislation on biological safety and biological protection. A comparative analysis was conducted of two previously proposed and published drafts of the Law of Ukraine «On Biological Safety and Biological Protection of Ukraine», separately developed in 2021 by the Ministry of Environmental Protection and Natural Resources of Ukraine and in 2023 by the Ministry of Health of Ukraine. These drafts, which underwent public discussion and mandatory consideration by other interested or involved structures in this process, were never submitted to the Verkhovna Rada of Ukraine (hereinafter referred to as the VRU), apparently due to significant shortcomings in these draft laws. Following a comparative analysis of the aforementioned draft laws, the authors concluded that each draft is rather limited and narrowly focused on departmental issues. As a result, they do not adequately fulfil the required level of general legal enforcement for biological safety and protection, which is essential for ensuring Ukraine's national security, in line with the stipulations outlined in the Law of Ukraine «On the Basic Principles (Strategy) of the State Environmental Policy of Ukraine for the Period Until 2030» and other applicable regulatory legal acts. Consequently, these drafts necessitate substantial revision. The authors proposed that the draft Law of Ukraine, «On Biological Safety and Biological Protection», developed by the Ministry of Health of Ukraine, should remain the primary document, as it aligns more closely with the objectives of legal regulation concerning biological threats to Ukraine's national security. Additionally, it is suggested that it be supplemented with specific articles from the draft law of the Ministry of Environment of Ukraine and that the definitions of particular terms, along with the content of several articles deemed in need of adjustment, be amended. Attention is drawn to the fact that, in accordance with the Implementation Plan of the Strategy for Ensuring Biological Safety and Biological Protection under the «One Health» principle for the period until 2025, it is necessary to create the National Biodiversity Gene Bank of Ukraine as an element of the state's biological safety and biological protection system. This is essential for managing, rationally using, and preserving resources of both natural and anthropogenic origin, including collections of biological agents. The need to legislatively consolidate the structure of the state biosafety and biosecurity system proposed by the authors is emphasised; the establishment of a passport for a new speciality in higher educational institutions of Ukraine, specifically for training specialists in biosafety and biosecurity, should be incorporated into the list of scientific specialities and speciality passports in Ukraine.