National normative tendencies in the field of biological safety and biological protection

Abstract

Keywords: biological safety, biological protection, antibiotic resistance, draft law ofUkraine «On biological safety and biological protection», common health, biologicalagents
 The strategic vectors of development of national legislationin the field of biological safety and biological protection (hereinafter the “BSBP”) throughthe analysis of the legal basis of Ukraine and draft laws are highlighted. Based on theDecision of the Council of the European Union (CFSP) 2019/1296 of 31.07.2019 it is revealedthe problems in the field of BSBP in Ukraine, namely: 1) there is no frameworklaw on BSBP in Ukraine, which would outline the system of the BSBP and its properfunctioning; 2) there are no mechanisms of state control over compliance with the requirementsof biological protection when working with biological agents; 3) there is no registerof business entities that work with harmful biological agents on the territory ofUkraine; 4) business entities that work with dangerous biological agents are not requiredby law to have the appropriate permits (licences); 5) there are no tools to control thereliability of staff and protect confidential information.Based on the draft legislation, the ways of overcoming the outlined issues are defined.The main provisions of the draft Law of Ukraine «On Biological safety and BiologicalProtection», the defining feature of which is the principle of «common health»,which is the foundation of building a system of BSBP in Ukraine is found out. Amongthe key provisions of the draft law: 1) defining the principles of state policy to ensure BSBP; 2) creation of a special body in the field of BSBP — the InterdepartmentalCommission on Biological Safety and Biological Protection; 3) introduction of classificationof biological agents into four risk groups depending on the degree of their individualand social danger, as well as the availability of means of treatment and preventionof infectious diseases caused by them: from the first to the fourth as the dangerincreases; 4) introduction of several control tools: a) notification of the start ofactivities with biological agents; b) inclusion of the business entity that plans to carryout activities on the circulation of biological agents to the State Register of the objectswith increased biological danger; c) licensing the activities of economic entities of thecirculation of biological agents of 2-4 risk groups.The common area for research of safety problem and pharmaceutical activity — thesubject of antibiotic resistance and normative measures to counteract it is analysed.