S. Zavriev (email@example.com),
Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 16/10, Miklukho-Maklaya Str., Moscow, 117997, Russian Federation;
Primakov National Research Institute of World Economy and International Relations, Russian Academy of Sciences (IMEMO), 23, Profsoyuznaya Str., Moscow, 117997, Russian Federation;
I. Shemyakin (firstname.lastname@example.org),
State Research Center of Applied Microbiology and Biotechnology, Obolensk, GNC PMB, Moscow region, 142279, Russian Federation
In 1980, German biochemist Barbara Hobom for the first time used the term “synthetic biology” when she described a transgenic bacterium constructed by use of DNA recombinant technology. Actually this direction has become active and has been widely developed only in the last decade. Today, this term is covered by a new branch of research which combines molecular biology and genetic manipulations for construction of new (yet not existing in nature) biologic functions and systems. The rapid growth of research in the field of molecular biology and genetics generates new trends, the development of which contributes to not only improving and expanding the possibilities of using its achievements for the benefit of humankind, but can also be used for illegal purposes. And one of the most vivid and promising trends is a synthetic biology, a new scientific direction in biology that deals with the design and creation of biological systems with prescribed properties and functions that have no analogs in nature. Theoretically, the modern possibilities of synthetic biology are limited only by the availability of a proper material base, the level of preparation and imagination of researchers. Base of state politics in area of chemical and biological safety focused on priority of directions, main tasks and mechanism for prevention of different chemical and biologic threats until 2025 was signed by the Russian president. The main purpose of these documents is a systematic decrease of negative impact of dangerous chemical and biological agents on humans and environment down to an appropriate level. The first Russian monitoring center was included in structure of All-Russian center for medicine of disaster Ministry of Health in January, 2019. The center will collect information about biological threats and analyze possible risks (including capabilities and achievements of synthetic biology). Existing international and Russian legal documents in bioethics issue are not harmonized, but provide a possibility to conduct clinical trials face I–III. Meanwhile, the necessity of further improvements of regulatory framework for the increasingly complex modern biomedical research involving the synthetic biology is obvious.
synthetic biology, biological weapons, biosafety, international cooperation
1. Berger K., Wood J., Jenkins B., Olsen J., Morse S. et al. Policy and Science for Global Health Security: Shaping the Course of International Health. Trop Med Infect Dis, 2019, vol. 4(2):60. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6631183 (accessed 10.04.2019).
2. Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction. Available at: http://www.un.org/ru/documents/decl_conv/conventions/bacweap.shtmlhttp://www.un.org/ru/documents/decl_conv/conventions/bacweap.shtml (accessed 21.09.2018).
3. The Cartagena Protocol on Biosafety. Available at: http://bch.cbd.int/protocol/text/ (accessed 21.09.2018).
4. Hobom B. Surgery of Genes – at the Doorstep of Synthetic Biology. Medizinische Klinik, 1980, bd. 75, no. 24, pp. 14-21.
5. Boldt J., ed. Synthetic Biology. Metaphors, Worldviews, Ethics, and Law. Wiesbaden, Springer VS Verlag fur Sozialwissenschaften, 2016. 234 p. DOI:10.1007/978-3-658-10988-2
6. Tucker J.B., Raymond A. Zilinskas R.A. The Promise and Perils of Synthetic Biology. The New Atlantis, 2006, vol. 12, pp. 25-45.
7. Tumpey T.M., Basler C.F., Aguilar P.V., Zeng H., Solorzano A., Swayne D.E., Cox N.J., Katz J.M., Taubenberger J.K., Palese P., Garcia-Sastre A. Characterization of the Reconstructed 1918 Spanish Influenza Pandemic Virus. Science, 2005, vol. 310, no. 5745, pp. 77-80.
8. Comprehensive program for the development of biotechnologies in the Russian Federation for the period up to 2020 (approved by the Government of Russian Federation on April 24, 2012, no. 1853p-P8 (In Russ.) Available at: http://base.garant.ru/70168244 (accessed 21.09.2018).
9. 2018 Competition program for the best scientific projects of interdisciplinary fundamental research on the topic “Synthetic Biology” (In Russ.) Available at: http://www.rfbr.ru/rffi/ru/contest/n_812/o_2057662 (accessed 21.09.2018).
10. The site of the Higher Attestation Commission (VAK) at the Ministry of Education and Science of the Russian Federation (In Russ.) Available at: http://vak.ed.gov.ru/316 (accessed 21.09.2018).
11. U.S. Trends in Synthetic Biology Research Funding. Washington DC, Wilson Center. 2015. 12 p. Available at: http://www.synbioproject.org/news (accessed 21.09.2018).
12. United States of America, Confidence Building Measure Return Covering 2014. Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. Submitted to the United Nations on April 15, 2015. 171 p. Available at: www.unog.ch/80256EDD006B8954/(httpAssets)/4631533639F1D34AC1257E380046511B/$file/BWC_CBM_2015_USA_Public.pdf (accessed 21.09.2018).
13. “On state regulation in the field of genetic engineering”. Federal law of July 05, 1996, no. 86-FZ (In Russ.) Available at: http://ivo.garant.ru/#/document/10135402/paragraph/10671:1 (accessed 21.09.2018).
14. Bases of the state policy in the field of ensuring chemical and biological safety of the Russian Federation for the period till 2025 and further prospect (approved by the President of the Russian Federation on November 1, 2013, no. Pr‑2573) (In Russ.) Available at: http://www.garant.ru/products/ipo/prime/doc/70423098/ (accessed 21.09.2018).
15. Pennisi E. Synthetic Biology: Synthetic Biology Remakes Small Genomes. Science, 2005, vol. 310, no. 5749, pp. 769-770.
16. The Darker Bioweapons Future. Available at: http://www.fas.org/irp/cia/product/bw1103.pdf (accessed 21.09.2018).
17. Cello J., Paul A.V., Wimmer E. Chemical Synthesis of Poliovirus cDNA: Generation of Infectious Virus in the Absence of Natural Template. Science, 2002, vol. 297, no. 5583, pp. 1016-1018.
18. Kaiser J. Resurrected Influenza Virus Yields Secrets of Deadly 1918 Pandemic. Science, 2005, vol. 310, no. 5745, pp. 28-29.
19. Biodefense in the Age of Synthetic Biology. National Academy of Sciences, Engineering, and Medicine. Washington DC, The National Academic Press, 2018. 234 p. DOI:https://doi.org/10.17226/24890/
20. Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). Available at: https://ec.europa.eu/health/scientific_committees/emerging/members_wg_en (accessed 21.09.2018).
21. Responsible life Sciences Research for Global Health Security. A Guidance Document. Available at: https://www.who.int/csr/bioriskreduction/lifesciences_research/en/ (accessed 21.09.2018).
22. Lentzos F. Biology’s Misuse Potential. Connections QJ, 2016, vol. 15, no. 2, pp. 48-64.
23. “On circulation of medicines”. Federal law of April 12, 2010, no. 61-FZ (In Russ.) Available at: https://rg.ru/2010/04/14/lekarstva-dok.html (accessed 21.09.2018).
24. “On approval of the rules of good clinical practice”. Order of the Ministry of health of the Russian Federation of April 1, 2016, no. 200n (In Russ.) Available at: http://www.garant.ru/products/ipo/prime/doc/71373446 (accessed 21.09.2018).
25. Council of Europe Convention on human rights and Biomedicine of 19 November 1996 (In Russ.) Available at: https://base.garant.ru/4089719/ (accessed 21.09.2018).
26. Beyl M. Znakomstvo s Konvenziei o pravach cheloveka i biomedicine [Introduction to the Convention on Human Rights and Biomedicine] Available at: https://rucont.ru/efd/568464 (accessed 21.09.2018).
27. Additional Protocol to the Convention on Human Rights and Biomedicine. 24 января 2002 г. Available at: http://www.conventions.ru/view_base.php?id=12210 (accessed 21.09.2018).
28. Foundation of the First Biothreat Informational and Monitoring Center in Russia (In Russ.) Available at: http://russian.rt.com/article/79257 (accessed 21.09.2018).
Registered in system SCIENCE INDEX