LEGAL REGULATION OF MOST DANGEROUS MICROORGANISMS STRAINS HANDLING
Authors: Pashkov V. M. 
Published: October 2021

Problem statement. The main issues that exist in the management of strains of particularly dangerous microorganisms are primarily related to the weakening of state supervision and control. Surprisingly, nowadays, there is no single official register of owners of pathogenic microorganisms and strains of dangerous and especially dangerous infectious diseases. Some biological objects are found, even in private collections. There are no permitting procedures for handling such facilities and sanctions for violating them.

That is why it is not surprising that the Prosecutor General’s Office has announced that the head of the State Research and Control Institute of Biotechnology and Microorganism Strains has identified dangerous virus strains that are known as infectious animal pathogens and can spread rapidly on a large scale across national borders. Dual-use studies should be supervised to address the risks arising from the development of biomedical sciences. Continuous monitoring and verification of scientific and technological advances sensitive from the point of view of security allow to minimize the possibility of the adoption of biological and toxic weapons and other risks.

Analysis of recent sources and publications. Theoretical issues of legal regulation of activities in the field of circulation of certain groups of drugs containing strains of microorganisms, in particular in vaccination, attract the attention of many researchers. They were studied, in particular by: R.A. Maidanyk, I.Ya. Senyuta, etc. However, the peculiarities of activities in the field of particularly dangerous microorganisms’ strains treatment have been left without due attention of researchers, including specialists in medical law.

Formulating Goals. The aim of the work is to study the state of relations in the field of especially dangerous microorganisms’ strains treatment legal regulation in Ukraine, analysis of the current legislation of Ukraine and the practice of its application in this area.

There have been used scientific publications of leading experts and current Ukrainian legislation. The research is based on an organic combination of general scientific and special legal research methods.

Presenting main material. The main sources of biological threats are: 1) epidemics and outbreaks of infectious human diseases; 2) epizootics (high incidence among animals); 3) epitophytia (spread of infectious plant disease in large areas); 4) accidents at biologically dangerous objects; 5) natural reservoirs of pathogenic microorganisms; 6) transboundary transfer of pathogenic microorganisms, representatives of flora and fauna, dangerous for ecological systems; 7) sabotage at biologically dangerous objects; 8) biological terrorism; 9) the use of biological weapons by the state. It should be noted that the regulatory framework in the field of particularly dangerous microorganisms’ strains treatment in the context of biosafety in Ukraine is fragmentary. Although the list of laws and other regulations governing biosafety and/or biosecurity in Ukraine is impressive.

Nowadays, the use of strains of microorganisms is gaining popularity, in particular in agriculture, because they can be used for the needs of veterinary medicine and for the production of certain foods such as yogurt, kefir etc. Therefore, in addition to the basic law, regulation of the use of strains and protection of rights to them is regulated by other acts, in particular the Law of Ukraine “On protection of rights to inventions and utility models”. Namely, in accordance with Part 2 of Art. 6 strains of microorganisms that have been bred or would be bred shall be considered as the objects of the invention.

It follows that the owner who invented the strain must certify the authorship and the right to obtain a patent or declaratory patent. However, this procedure, unlike others, is complicated. After all, to obtain a full patent, you need to conduct an appropriate qualification examination, which would establish whether the strain meets the conditions of patentability.

Also, in addition to filing an application for the invention of a utility model and obtaining a patent, in accordance with the Law of Ukraine “On Veterinary Medicine” when registering a domestic veterinary immunobiological agent, the applicant must deposit strains of microorganisms in a special collection – depository. There are currently three national depositories in Ukraine, each of which specializes in a specific type: non-pathogenic strains; pathogenic to humans; pathogenic to animals. The procedure of depositing strains of microorganisms is carried out in accordance with the Instruction on the procedure of depositing strains of microorganisms in Ukraine for the purpose of patent procedure, approved by the order № 106/115 of the State Patent and the National Academy of Sciences of Ukraine of 26.06.1995.

Moreover, in accordance with the Regulations on the National Center for Microorganism Strains and the procedure for depositing microorganism strains, approved by the Cabinet of Ministers of Ukraine regulation № 637 of 07.05.1998, deposit of microorganism strains in Ukraine is carried out by the National Center for Microorganism Strains. Its task is to preserve the production and control of strains of microorganisms, maintain biotechnological indicators, control the state of their population, as well as the preparation of new strains.

It is necessary to pay attention to the decision of the National Security and Defense Council of Ukraine “On Biosafety of Ukraine”, which states that at the moment there is an increase in the negative impact of various biological factors on the population, which may lead to threats of biological origin.

The reasons for such plural regulation are: 1) the lack of a program on biosafety and prevention of biological terrorism, no national system of counteraction to possible biothreats; 2) no automated and integrated data banks on possible threats of biological and chemical origin. Funding and logistics for laboratories also remain unsatisfactory. Also, the state supervision and control in the field of biosafety is weakened, namely when the owner of high-risk facilities changes or when there is a risk of unauthorized access to laboratories due to imperfect protection of pathogenic microorganisms and strains of dangerous and especially dangerous infectious diseases, which in turn can lead to the leakage of pathogenic microorganisms into the environment and cause mass infectious disease.

In addition, there is a legal gap in the legislation of Ukraine regarding the location and control of viral and biological laboratories by foreign states. However, in almost all European countries, as well as in the United States, domestic law prohibits the placement of such laboratories in these countries, because they are potentially dangerous to the population. The danger behind viral and biological laboratories, even with the strictest observance of all necessary safety rules, is extremely great, because the pathogenic microorganisms of human and animal origin in them are considered potential agents of biological weapons. Although Ukraine ratified the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction of 10 April, 1972, an agreement was signed in 2005 between the US Department of Defense and the Ministry of Health of Ukraine (expired on 31.05.2013) regarding cooperation in the field of prevention of the spread of technologies, pathogens and knowledge that can be used in the development of biological weapons and the US Department of Defense has begun construction of its objects on the territory of our country. At the same time, microbiological laboratories and production facilities are considered to be areas of the highest biological risk. Infecting of persons while working with microorganisms in laboratories is noted throughout the existence of microbiology and is considered as an indisputable confirmation of occupational hazards. In general, there is a wide variety of ways of potential attacks involving bio-toxic weapons and there are several ways to assimilate biotechnologies with their transformation into weapons due to: 1) use of various agents (e.g., bacteria, viruses, fungi, toxins, bioregulators); 2) use against various aims (humans, animals and plants); 3) different scales of application (tactical, strategic); 4) use for various purposes (open or covert war, murder, terrorism or criminal activity). Probably because of this, in 2012 the WHO adopted the Framework Strategy for Laboratory Biorisk Management for 2012-2016, aimed at creating sustainable global, regional and national plans for biological risk management in laboratories. It recognizes that “In accordance with the International Health Regulations (IHR (2005), all participating countries have made a legal commitment to evaluate, develop and maintain their national key oversight, evaluation and response functions”.

Conclusions. The current state of legal regulation of relations in the field of strain management requires, given the intersectoral nature of the issue, consideration of the creation of a single intersectoral body for the supervision of hazardous biological objects. Such a body may not only be a licensing body, but also responsible for the introduction of a register of owners of hazardous biological objects that are not economic entities (for example, individual owners of collections of such biological objects). In this paper, it is impractical to consider the circulation of products with GMOs, on the one hand, this issue is perfectly regulated in other special regulations, on the other hand, today there is an issue concerning the treatment of dangerous strains of pathogenic viruses, bacteria and other microorganisms and toxins, as well as poisons of animal and plant origin.

For entities engaged in economic activities with pathogenic microorganisms and strains of dangerous infectious diseases, it is advisable to introduce licensing of this type of activity, which requires further development of a bylaw on licensing conditions. For other persons who are the owners of such biological objects and who are not engaged in economic activities, it is necessary to introduce other forms of permit, including special requirements for their handling and storage conditions.

The next important bylaw should be the Regulations on the state register of pathogenic microorganisms and strains of dangerous and especially dangerous infectious diseases.

Particular attention should be paid to the disposal of hazardous biological objects. Nowadays, for example, there is no effective system for the disposal of vaccines and other immunobiological drugs that have expired (for reference, the shelf life of the flu vaccine is 7-8 months). The cost of recycling is not always profitable for pharmaceutical operators. There are cases when such drugs are falsified by replacing the expiration date, which adversely affect the health of patients. In this context, it can also be mentioned the fact of importing humanitarian aid in Ukraine in the form of a vaccine against measles and rubella (from the Ukrainian diaspora in Canada). The storage temperature of this vaccine was up to minus 48 degrees. After importation into the customs territory of Ukraine, given the shortcomings of customs legislation and the lack of effective control, the temperature regime was not observed. However, the Ministry of Health still carried out compulsory vaccination of children (there were cases of deteriorating health), which is not only negative for the health of children, but also for the very idea of vaccination.

In this case, the Ministry of Health, given the interest, was not able to make the right and lawful decision. This is why an independent intersectoral body of state control (supervision) is needed.