NEW GEORGIAN LEGISLATION ON BIOSAFETY

Abstract

Georgia, when it was part of the Soviet Union, shared all legislation, amongst which the regulations on biosafety and dealing with especially dangerous pathogens, with other republics of the country. Biosafety rules in Soviet Union were very strict, and they did not leave gaps for misunderstanding. Bioweapon facilities were well defined, they were components of Soviet offensive biological weapons program, and no other institutions were authorized to have any especially dangerous pathogens. More than a decade has passed since Georgia became independent, but not all the biosafety legislation has been adapted to the new situation. New Georgian laws were adopted, part of the sanitary norms and regulations were renewed, but the greatest part remains unchanged. For example, even the classification of pathogens by risk groups is absolutely contrary to the WHO classification. Today, when the threat of bioterrorism is more realistic, the need for a new regulatory basis for biosafety has become evident. Furthermore, scientific investigations on especially dangerous pathogens are very well funded by different donors, and sometimes they do not take into account whether the proposed recipients of their grants are eligible to carry out such investigations, and whether or not they have sufficient experience. There were not very many bioweapon-related institutions in Georgia (compared for example with Russia and Kazakhstan) the Georgian Anti-Plague Station (now the National Center for Disease Control and Medical Statistics of Georgia NCDC Georgia of the Ministry of Labor, Health and Social Affairs of Georgia), carries out surveillance on especially dangerous pathogens in the whole territory of Georgia; Biokombinat in Tabakhmela produces live vaccines for foot and mouth disease, etc.; and, in part, the Eliava Institute of Bacteriophage manufactures different vaccines. All these institutions carry out controlled activities with dangerous pathogens. After the collapse of the Soviet Union there was a significant outflow of military microbiologists to other institutions, often to private companies, and this is the source of concern. Nowadays investigations with especially dangerous pathogens are carried out according to old Soviet regulations: (1) The Decree of the Ministry of Health of the USSR “Concerning Rules of Registration, Containment, Handling and Transfer of Cultures of Pathogenic Bacteria, Viruses, Rickettsia, Fungi, Protozoa and others, also Bacterial Toxins and Poisons of Biological Origin“ approved by the Ministry of Health of USSR, 18.05.79. The “Instruction on Regime of Control of Epidemics while Working with Materials Infected or Suspected to be Infected with Causative Agents of Infectious Diseases of 1-11 Groups” approved by the Ministry of Health of USSR 29.06.1978. Among the various other duties of the NCDC Georgia, according to the Decree of the President of Georgia No. 55 of February 21, 2003, in its statute is the “Participation in drafting normative and methodological documents on surveillance, disease control and prevention, biosafetyhiosecurity”. The Department of Biosafety and Threat Reduction, together with experts from other departments of the Ministry of Labor, Health and Social Affairs of Georgia drafts biosafety legislation. (2)