Some questions of legal regulation of bioprinting in Russia
( Pp. 196-204)
More about authors
Akhmadova Maryam Abdurakhmanovna
Yurist, kandidat yurid. nauk, PhD, LL.M, Glavnoe kontrolnoe upravlenie goroda Moskvy
Main Control Department of the city of Moscow
Russia, Moscow
Main Control Department of the city of Moscow
Russia, Moscow
Abstract:
The article provides an overview of current regulatory acts of the Russian Federation on various aspects of the legal regulation of the use of additive technologies in domestic medicine. The authors draw attention to the question of the legal nature of bioprint organs. In the study, such methods of scientific knowledge were used as: general scientific dialectic, formal legal and comparative legal methods. At the same time, the author proceeds from the subjective-objective backside of processes and phenomena, as well as their relationship. This means that all people can use the technology of a new generation, which can cause a therapeutic or preventive effect. This condition is the need for the formation of new legal issues in this area through modernization.
How to Cite:
Akhmadova M.A., (2020), SOME QUESTIONS OF LEGAL REGULATION OF BIOPRINTING IN RUSSIA. Sociopolitical Sciences, 2 => 196-204.
Reference list:
Romanovskaya O.V., Romanovskiy G.B. i dr. Pravo i genetika // Biomeditsinskoe pravo v Rossii i za rubezhom: monografiya / G.B. Romanovskiy, N.N. Tarusina, A.A. Mokhov i dr. M.: Prospekt, 2015. S. 145.
Biomeditsina - 2040: Gorizonty nauki glazami uchenykh / pod red. V.N. Knyagina, M.S. Lipetskoy. SPb.: Fond strategicheskikh razrabotok Severo-Zapad , 2017. 95 s.
Bogdanov D.E. Tekhnologiya bioprintinga kak legal nyy vyzov: opredelenie modeli pravovogo regulirovaniya // Lex Russica. Zakon russkiy. 2019. №. 6. S. 80-91. DOI: https:// doi.org/10.17803/1729-5920.2019.151.6.080-091 (data obrashcheniya: 17.09.2019).
Vasil eva E.A. i dr. Primenenie sistemy napravlennogo genomnogo redaktirovaniya CRISPR/Cas k plyuripotentnym stvolovym kletkam // TSitologiya. 2015. T. 57. № 1. S. 19.
Vladimirskaya E.B. Biologicheskie osnovy i perspektivy terapii stvolovymi kletkami / E.B. Vladimirskaya, O.A. Mayorova, S.A. Rumyantsev. M.: Meditsina i zdorov e, 2007. S. 153.
Direktiva 98/44/ES Evropeyskogo parlamenta Soveta po pravovoy zashchite biotekhnologicheskikh izobreteniy ot 6 iyulya 1998 g. // Official Journal of the European Communities. 1998. № 213. Pp. 13-21.
Belikova K.M. Pravo intellektual noy sobstvennosti Evropeyskogo Soyuza: uchebnoe posobie / K.M. Belikova. M.: MDMPrint, 2019. S. 91-99.
Zakon Rossiyskoy Federatsii ot 22.12.1992 № 4180-1 O transplantatsii organov i (ili) tkaney cheloveka // Konsul tantPlyus: spravochnaya pravovaya sistema. URL: http://www.consultant.ru/document/cons doc LAW 4692 (data obrashcheniya: 30.02.2020).
Ivanov D.V., CHabanenko A.V. Zakon o kletochnykh produktakh: proryv ili porazheniya // Vestnik novykh meditsinskikh tekhnologiy. 2017. T. 24. № 4. S. 166-176.
Inshakova A.O. i dr. Pravovaya zashchita biotekhnologiy v RF: preimushchestva patentovaniya i kriterii patentosposobnosti // Vestn. Volgogr. gos. un-ta. Ser. 5: YUrisprudentsiya. 2015. № 3 (28). S. 26-34.
Kompleksnaya programma razvitiya biotekhnologiy v RF na period do 2020 goda. URL: http://docs.cntd.ru/ document/420389398 (data obrashcheniya: 03.03.2020).
Konventsiya o vydache evropeyskikh patentov (Evropeyskaya patentnaya konventsiya) ot 5 oktyabrya 1973 g. // OJ EPO. 2001. № 4. C. 55.
Kontseptsiya o gosudarstvennoy politike Rossiyskoy Federatsii v oblasti mezhdunarodnogo nauchno-tekhnicheskogo sotrudnichestva (utv. Pravitel stvom Rossiyskoy Federatsii 20 yanvarya 2000 g.). URL: https://www.mid.ru/foreign policy/official documents//asset publisher/CptICkB6BZ29/ content/ id/589776 (data obrashcheniya: 02.04.2020).
Korsakov I.N i dr. Analiz rynka produktov regenerativnoy meditsiny // Geny i kletki. 2017. T. XII. № 1. S. 83.
Kravtsov R.V., Karavaeva E.I. Biomeditsinskie tekhnologii: voprosy pravovogo regulirovaniya i otvetstvennosti // Sibirskiy yuridicheskiy vestnik. 2005. № 3. S. 7-12.
Ponomareva D.V. Patentovanie chelovecheskikh genov: sudebnaya praktika SSHA, Kanady i Avstralii // Aktual nye problem rossiyskogo prava. 2019. № 9 (106). S. 166-173.
Prikaz Rospatenta O vvedenii v deystvie Rukovodstva po ekspertize zayavok na izobreteniya ot 25 iyulya 2011 g. № 87 (utratil silu) // SPS Konsul tantPlyus (data obrashcheniya: 20.04.2020).
Pravovye aspekty nauchnykh issledovaniy v oblasti razvitiya kletochnykh tekhnologiy i vnedreniya ikh v klinicheskuyu praktiku / A.V. Vasil ev i dr. // Meditsinskoe pravo. 2010. № 3. S. 9-14.
Rifkin Dzh. Tret ya promyshlennaya revolyutsiya. Kak gorizontal nye vzaimodeystviya menyayut energetiku, ekonomiku i mir v tselom / per. s angl. M.: Al pina non-fikshn, 2014. 410 s.
Romanovskiy G.B., Romanovskaya O.V. Pravovoe regulirovanie biomeditsinskikh tekhnologiy v Rossiyskoy Federatsii // Vestnik rossiyskogo gumanitarnogo fonda. 2015. № 3 (80). S. 102-112.
Salagay O.O. Obshchie polozheniya prava Evropeyskogo soyuza, primenimye k kletkam i tkanyam cheloveka // Meditsinskoe pravo. 2011. № 5. S. 6-10.
Salagay O.O. Podkhody ES k regulirovaniyu kletochnoy terapii // Pravo i politika. 2012. № 8. S. 1357-1363;
Semenova V.M. i dr. Proliferativnyy i differentsirovochnyy potentsial mezenkhimal nykh stvolovykh kletok iz zhirovoy tkani v usloviyakh kul tivirovaniya // Ukrains kiy neyrokhirurgichniy zhurnal. 2014. № 3. S. 24-29.
Sergeev YU.D., Mokhov A.A., YAvorskiy A.N. Pilotnyy (eksperimental nyy) pravovoy rezhim dlya otechestvennoy biomeditsinskoy nauki i praktiki // Meditsinskoe pravo. 2019. № 4. S. 3-13.
Tokarev B.E., Tokarev R.B. Analiz rynka 3D-pechati: tekhnologii i igroki // Prakticheskiy marketing. 2014. № 2 (204). S. 10-16.
Tokarev B.E., Tokarev R.B. Analiz rynochnykh perspektiv tekhnologiy biopechati // Internet-zhurnal Naukovedenie . 2016. T. 8, № 2 URL: https://cyberleninka.ru/article/n/ analiz-rynochnyh-perspektiv-tehnologiy-3rbiopechati/viewer (data obrashcheniya: 18.04.2020).
Federal nyy zakon ot 21 noyabrya 2011 g. № 323-FZ Ob osnovakh okhrany zdorov ya grazhdan v Rossiyskoy Federatsii // Rossiyskaya gazeta. 2011. № 263.9951.
Federal nyy zakon ot 23.06.2016 g. № 180-FZ O biomeditsinskikh kletochnykh produktakh // Sobranie zakonodatel stva Rossiyskoy Federatsii ot 27 iyunya 2016 g. № 26 (chast I), st. 3849.
Federal nyy zakon ot 5 iyulya 1996 g. № 86-FZ O gosudarstvennom regulirovanii v oblasti genno-inzhenernoy deyatel nosti // Sobranie zakonodatel stva Rossiyskoy Federatsii ot 8 iyulya 1996 g. № 28, st. 3348.
SHaverdin A.V. Sozdanie i ispol zovanie biotekhnologiy: istoriya voprosa // ZHurnal rossiyskogo prava. 2012. № 6. S. 118-126.
SHvab K. CHetvertaya promyshlennaya revolyutsiya. M.: Eksmo, 2016. S. 17.
Association for Molecular Pathology vs Myriad Genetics. URL: https://www.oyez.org/cases/2012/12-398 (data obrashcheniya: 20.04.2020).
Gartner: 3D Printing to Result in 100 Billion IP Losses per Year, 3DERS.ORG. URL: http://www.3ders.org/articles/20131014-gartner-3d-printing-to-result-in-100-billionip-losses-per-year.html (data obrashcheniya: 18.04.2020).
Global Forum on Law Justice and Development Patentability, Global Development and Ethical Considerations of Bioprinting (Draft 2017). URL: http://globalforumljd.com/sites/default/files/resource/patent-bioprininting.pdf (data obrashcheniya: 17.01.2020).
Hannes K. The ethical controversy about 3D bioprinting from the perspective of european patent law. 2018. P. 8. URL: http://arno.uvt.nl/show.cgi fid 144814 (data obrashcheniya: 21.01.2020).
Kelly E. FDA regulation of 3D-printed organs and associated ethical challenges. University of Pennsylvania Law Review. 2018. Vol. 166. Iss. 1. Pp. 515-545.
National Institute of Health. Stem Cell Information. URL: https://stemcells.nih.gov/info/faqs.htm classes (data obrashcheniya: 21.01.2020).
Phoebe H. Li. 3D bioprinting technologies: Patents, innovation and access, law, innovation and technology. 2014. Vol. 6. No. 2. Pp. 282-304. DOI: 10.5235/17579961.6.2.282.
Press Release, The Gartner Group, Gartner Says Uses of 3D Printing Will Ignite Major Debate on Ethics and Regulation (Jan. 29, 2014). URL: https://www.gartner.com/en/newsroom/ press-releases/2014-01-29-gartner-says-uses-of-3d-printingwill-ignite-major-debate-on-ethics-and-regulation (data obrashcheniya: 02.04.2020).
Takahashi K., Tanabe K., Ohnuki M. et al. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell. 2007. No. 131. Pr. 861-872.
The Next Pharmaceutical Revolution Could Be 3D Bioprinted. URL: https://www.sciencealert.com/thenext-pharmaceutical-revolution-could-be-3d-bioprinted (data obrashcheniya: 17.01.2020);
Tran J.L. Bioprint or not to bioprint. North Carolina Journal of Law and Technology. 2015. Vol. 17. Iss. 1. Pp. 123-178.
Biomeditsina - 2040: Gorizonty nauki glazami uchenykh / pod red. V.N. Knyagina, M.S. Lipetskoy. SPb.: Fond strategicheskikh razrabotok Severo-Zapad , 2017. 95 s.
Bogdanov D.E. Tekhnologiya bioprintinga kak legal nyy vyzov: opredelenie modeli pravovogo regulirovaniya // Lex Russica. Zakon russkiy. 2019. №. 6. S. 80-91. DOI: https:// doi.org/10.17803/1729-5920.2019.151.6.080-091 (data obrashcheniya: 17.09.2019).
Vasil eva E.A. i dr. Primenenie sistemy napravlennogo genomnogo redaktirovaniya CRISPR/Cas k plyuripotentnym stvolovym kletkam // TSitologiya. 2015. T. 57. № 1. S. 19.
Vladimirskaya E.B. Biologicheskie osnovy i perspektivy terapii stvolovymi kletkami / E.B. Vladimirskaya, O.A. Mayorova, S.A. Rumyantsev. M.: Meditsina i zdorov e, 2007. S. 153.
Direktiva 98/44/ES Evropeyskogo parlamenta Soveta po pravovoy zashchite biotekhnologicheskikh izobreteniy ot 6 iyulya 1998 g. // Official Journal of the European Communities. 1998. № 213. Pp. 13-21.
Belikova K.M. Pravo intellektual noy sobstvennosti Evropeyskogo Soyuza: uchebnoe posobie / K.M. Belikova. M.: MDMPrint, 2019. S. 91-99.
Zakon Rossiyskoy Federatsii ot 22.12.1992 № 4180-1 O transplantatsii organov i (ili) tkaney cheloveka // Konsul tantPlyus: spravochnaya pravovaya sistema. URL: http://www.consultant.ru/document/cons doc LAW 4692 (data obrashcheniya: 30.02.2020).
Ivanov D.V., CHabanenko A.V. Zakon o kletochnykh produktakh: proryv ili porazheniya // Vestnik novykh meditsinskikh tekhnologiy. 2017. T. 24. № 4. S. 166-176.
Inshakova A.O. i dr. Pravovaya zashchita biotekhnologiy v RF: preimushchestva patentovaniya i kriterii patentosposobnosti // Vestn. Volgogr. gos. un-ta. Ser. 5: YUrisprudentsiya. 2015. № 3 (28). S. 26-34.
Kompleksnaya programma razvitiya biotekhnologiy v RF na period do 2020 goda. URL: http://docs.cntd.ru/ document/420389398 (data obrashcheniya: 03.03.2020).
Konventsiya o vydache evropeyskikh patentov (Evropeyskaya patentnaya konventsiya) ot 5 oktyabrya 1973 g. // OJ EPO. 2001. № 4. C. 55.
Kontseptsiya o gosudarstvennoy politike Rossiyskoy Federatsii v oblasti mezhdunarodnogo nauchno-tekhnicheskogo sotrudnichestva (utv. Pravitel stvom Rossiyskoy Federatsii 20 yanvarya 2000 g.). URL: https://www.mid.ru/foreign policy/official documents//asset publisher/CptICkB6BZ29/ content/ id/589776 (data obrashcheniya: 02.04.2020).
Korsakov I.N i dr. Analiz rynka produktov regenerativnoy meditsiny // Geny i kletki. 2017. T. XII. № 1. S. 83.
Kravtsov R.V., Karavaeva E.I. Biomeditsinskie tekhnologii: voprosy pravovogo regulirovaniya i otvetstvennosti // Sibirskiy yuridicheskiy vestnik. 2005. № 3. S. 7-12.
Ponomareva D.V. Patentovanie chelovecheskikh genov: sudebnaya praktika SSHA, Kanady i Avstralii // Aktual nye problem rossiyskogo prava. 2019. № 9 (106). S. 166-173.
Prikaz Rospatenta O vvedenii v deystvie Rukovodstva po ekspertize zayavok na izobreteniya ot 25 iyulya 2011 g. № 87 (utratil silu) // SPS Konsul tantPlyus (data obrashcheniya: 20.04.2020).
Pravovye aspekty nauchnykh issledovaniy v oblasti razvitiya kletochnykh tekhnologiy i vnedreniya ikh v klinicheskuyu praktiku / A.V. Vasil ev i dr. // Meditsinskoe pravo. 2010. № 3. S. 9-14.
Rifkin Dzh. Tret ya promyshlennaya revolyutsiya. Kak gorizontal nye vzaimodeystviya menyayut energetiku, ekonomiku i mir v tselom / per. s angl. M.: Al pina non-fikshn, 2014. 410 s.
Romanovskiy G.B., Romanovskaya O.V. Pravovoe regulirovanie biomeditsinskikh tekhnologiy v Rossiyskoy Federatsii // Vestnik rossiyskogo gumanitarnogo fonda. 2015. № 3 (80). S. 102-112.
Salagay O.O. Obshchie polozheniya prava Evropeyskogo soyuza, primenimye k kletkam i tkanyam cheloveka // Meditsinskoe pravo. 2011. № 5. S. 6-10.
Salagay O.O. Podkhody ES k regulirovaniyu kletochnoy terapii // Pravo i politika. 2012. № 8. S. 1357-1363;
Semenova V.M. i dr. Proliferativnyy i differentsirovochnyy potentsial mezenkhimal nykh stvolovykh kletok iz zhirovoy tkani v usloviyakh kul tivirovaniya // Ukrains kiy neyrokhirurgichniy zhurnal. 2014. № 3. S. 24-29.
Sergeev YU.D., Mokhov A.A., YAvorskiy A.N. Pilotnyy (eksperimental nyy) pravovoy rezhim dlya otechestvennoy biomeditsinskoy nauki i praktiki // Meditsinskoe pravo. 2019. № 4. S. 3-13.
Tokarev B.E., Tokarev R.B. Analiz rynka 3D-pechati: tekhnologii i igroki // Prakticheskiy marketing. 2014. № 2 (204). S. 10-16.
Tokarev B.E., Tokarev R.B. Analiz rynochnykh perspektiv tekhnologiy biopechati // Internet-zhurnal Naukovedenie . 2016. T. 8, № 2 URL: https://cyberleninka.ru/article/n/ analiz-rynochnyh-perspektiv-tehnologiy-3rbiopechati/viewer (data obrashcheniya: 18.04.2020).
Federal nyy zakon ot 21 noyabrya 2011 g. № 323-FZ Ob osnovakh okhrany zdorov ya grazhdan v Rossiyskoy Federatsii // Rossiyskaya gazeta. 2011. № 263.9951.
Federal nyy zakon ot 23.06.2016 g. № 180-FZ O biomeditsinskikh kletochnykh produktakh // Sobranie zakonodatel stva Rossiyskoy Federatsii ot 27 iyunya 2016 g. № 26 (chast I), st. 3849.
Federal nyy zakon ot 5 iyulya 1996 g. № 86-FZ O gosudarstvennom regulirovanii v oblasti genno-inzhenernoy deyatel nosti // Sobranie zakonodatel stva Rossiyskoy Federatsii ot 8 iyulya 1996 g. № 28, st. 3348.
SHaverdin A.V. Sozdanie i ispol zovanie biotekhnologiy: istoriya voprosa // ZHurnal rossiyskogo prava. 2012. № 6. S. 118-126.
SHvab K. CHetvertaya promyshlennaya revolyutsiya. M.: Eksmo, 2016. S. 17.
Association for Molecular Pathology vs Myriad Genetics. URL: https://www.oyez.org/cases/2012/12-398 (data obrashcheniya: 20.04.2020).
Gartner: 3D Printing to Result in 100 Billion IP Losses per Year, 3DERS.ORG. URL: http://www.3ders.org/articles/20131014-gartner-3d-printing-to-result-in-100-billionip-losses-per-year.html (data obrashcheniya: 18.04.2020).
Global Forum on Law Justice and Development Patentability, Global Development and Ethical Considerations of Bioprinting (Draft 2017). URL: http://globalforumljd.com/sites/default/files/resource/patent-bioprininting.pdf (data obrashcheniya: 17.01.2020).
Hannes K. The ethical controversy about 3D bioprinting from the perspective of european patent law. 2018. P. 8. URL: http://arno.uvt.nl/show.cgi fid 144814 (data obrashcheniya: 21.01.2020).
Kelly E. FDA regulation of 3D-printed organs and associated ethical challenges. University of Pennsylvania Law Review. 2018. Vol. 166. Iss. 1. Pp. 515-545.
National Institute of Health. Stem Cell Information. URL: https://stemcells.nih.gov/info/faqs.htm classes (data obrashcheniya: 21.01.2020).
Phoebe H. Li. 3D bioprinting technologies: Patents, innovation and access, law, innovation and technology. 2014. Vol. 6. No. 2. Pp. 282-304. DOI: 10.5235/17579961.6.2.282.
Press Release, The Gartner Group, Gartner Says Uses of 3D Printing Will Ignite Major Debate on Ethics and Regulation (Jan. 29, 2014). URL: https://www.gartner.com/en/newsroom/ press-releases/2014-01-29-gartner-says-uses-of-3d-printingwill-ignite-major-debate-on-ethics-and-regulation (data obrashcheniya: 02.04.2020).
Takahashi K., Tanabe K., Ohnuki M. et al. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell. 2007. No. 131. Pr. 861-872.
The Next Pharmaceutical Revolution Could Be 3D Bioprinted. URL: https://www.sciencealert.com/thenext-pharmaceutical-revolution-could-be-3d-bioprinted (data obrashcheniya: 17.01.2020);
Tran J.L. Bioprint or not to bioprint. North Carolina Journal of Law and Technology. 2015. Vol. 17. Iss. 1. Pp. 123-178.
Keywords:
doctrine “products of nature”, bioprinting, induced pluripotent stem cell, intellectual property, 3D printing technology, patent, invention, transplantology, biomedicine.
