Analysis of the peculiarities of the legal status of the State Service of Ukraine on Medicines and Drug Control at the present stage
DOI:
https://doi.org/10.24959/sphhcj.23.294Keywords:
legal status; public governance; public administration; competence; functions; tasks; quality control; medicinesAbstract
Aim. To determine the main features of the legal status of the State Service of Ukraine on Medicines and Drug Control; to reveal the importance of this body as a subject of public administration and governance in the field of healthcare at the present stage.
Materials and methods. The materials used were the legislation of Ukraine, information from the official websites of international organizations, government agencies of Ukraine and foreign countries, monographs, theses, and scientific articles. Such methods as analysis, synthesis, classification, grouping, formal-dogmatic, logical-semantic, ascent from abstract to concrete, historical, comparative, as well systematic, and graphic methods were applied.
Results. Based on the study of the current legal acts, as well as those that are important as historical sources, three main stages in the formation of the system of state bodies of Ukraine implementing the state policy in the areas of quality control and safety of medicines, medicinal products, circulation of narcotic drugs, psychotropic substances and precursors, and counteraction to their illicit trafficking have been identified. Taking into account historical trends and foreign experience, additional arguments in favor of expanding the powers of this body are given. It has been proposed to classify the specific functions of the State Service of Ukraine on Medicines and Drug Control, which characterize its legal status, as well as serve as distinguishing features in relation to other central executive authorities, into rule-making, regulatory (provision of administrative services), control and supervisory, and information and communication functions. The practical measures of cooperation between the State Service of Ukraine on Medicines and Drug Control and other state bodies and non-governmental organizations have been summarized, and on this basis, 2 levels of cooperation – international and national – have been identified. It has been found that memoranda are the predominant legal form of cooperation at both levels. The classification of the bodies with which the State Service of Ukraine on Medicines and Drug Control has signed memoranda of cooperation has been made.
Conclusions. Based on the analysis, the authors offer their own definitions of the concepts of “legal status” and “competence” of the State Service of Ukraine on Medicines and Drugs Control, and distinctions between the categories of “functions” and “tasks”, “public governance in the field of healthcare” and “public administration in the field of healthcare”. The features that characterize the legal status of the State Service of Ukraine on Medicines and Drugs Control have been identified, and the classification of its specific functions at the present stage has been proposed.
References
Kotvitska, A. A., Кubarieva, I. V., Volkova, A. V., Boldar, G. E., Cherkashyna, A. V. (2020). Determining the position of pharmaceutical law in the modern legal system of Ukrainea. Farmatsevtychnyi chasopys, No. 4, 89–97. doi: https://doi.org/10.11603/2312-0967.2020.4.11542.
Pashkov, V., Kotvitska, A., Harkusha, A. (2017). Legal regulation of the production and trade of medical devices and medical equipment in the EU and US: experience for Ukraine. Wiadomosci lekarskie (Warsaw, Poland : 1960), 70(3 pt 2), 614–618.
Kotvitska, A. A., Suvorov, M. O., Posylkina, O. V. (2021). Sotsialna farmatsiia: stan, problemy ta perspektyvy. Kharkiv, 376–379. Available at: https://drive.google.com/file/d/1I-9abWlGzWa8BBeAV4FtR2YvT52UxWT8/view.
Suvorov, M. O., Kotvitska, A. A., Posylkina, O. V. (2023). Formuvannia Natsionalnoi likárskoi polityky za umov vprovadzhennia medychnoho strakhuvannia: pytannia osvity, teorii ta praktyky. Kharkiv, 163–170. Available at: https://dspace.nuph.edu.ua/bitstream/123456789/30580/1/163-170.pdf.
Suvorov, M. O., Kotvitska, A. A., Posylkina, O. V. (2023). Sotsialna farmatsiia: stan, problemy ta perspektyvy. Kharkiv, 37–46. Available at: https://socpharm.nuph.edu.ua/wp-content/blogs.dir/10/files/2023/05/sotsialna-farmatsiia_materialy-2023.pdf.
Suvorov, M. O., Kotvitska, A. A., Posylkina, O. V. (2023). Study of worldwide experience of organizational structure of regulatory systems in the field of circulation of medicinal products. Aktualni problemy yakosti, menedzhmentu i ekonomiky u farmatsii i okhoroni zdorovia. Kharkiv, 35–46. Available at: https://dspace.nuph.edu.ua/bitstream/123456789/30653/1/35-46.pdf.
Lohvynenko, B. O. (2017). Publichne administruvannia sferoiu okhorony zdorovia: teoriia i praktyka. Kyiv: MP Lesia, 344.
Gomon, D. O. (2018). Administrative, legal and organizational healthcare maintaining in Ukraine. PhD thesis abstract. Odessa. Available at: https://oduvs.edu.ua/wp-content/uploads/2016/06/Avtoreferat_Gomon_Dari_Olegivni.pdf.
Volk, N. V. (2018). Administrative-legal adjusting of activity of pharmaceutical industry of Ukraine. PhD thesis abstract. Kyiv. Available at: https://dglib.nubip.edu.ua/server/api/core/bitstreams/3e38d724-e585-4e5a-89fe-1c18415a27cd/content.
Volk, N. V., Svitlychnyy, О. Р. (2018). Administrative and legal adjusting of activity of pharmaceutical industry of Ukraine : ways to improve. Kyiv : NUBiP Ukrainy, 185 р.
Strelchenko, O. H. (2019). Doctrinal characteristics of the subjects of public administration of the sphere of drug circulation. Publichne upravlinnia ta mytne administruvannia, No. 1 (20), 7–13. doi: https://doi.org/10.32836/2310-9653-2019-1-7-13.
Strelchenko, O. H. (2019). Public administration in the field of drug circulation. Doctor thesis abstract. Dnipro. Available at: https://dduvs.in.ua/wp-content/uploads/files/Structure/science/rada/auto/30/3.pdf.
Khovpun, O. S. (2021) Administrative and Legal Provision of Pharmacia in Ukraine. Doctor thesis abstract. Ternopil. Available at: http://dspace.wunu.edu.ua/bitstream/316497/41793/1/aref-hovptyn-na-sait.pdf.
Shovkoplias, O. V. (2021). On the issue of administrative and legal regulation in the field of health care. Pravo i suspilstvo. No. 2, 119–124. doi: https://doi.org/10.32842/2078-3736/2021.2.18.
Ubohov, S. (219). Methodological and applied foundations of the integrative model of quality assurance of medicines at the stages of realization and medical application. Doctor’s thesis. Kyiv, 604 р. Available at: https://www.nuozu.edu.ua/zagruzka2/DrAr/Dr_Ubohov.pdf.
Lebed, S. O., Nemchenko A. S. (2021). Aktualni problemy rozvytku haluzevoi ekonomiky ta lohistyky. Kharkiv, 171–173.
Lebed, S. O. (2022). Improvement of modern approaches to counteracting and combating the circulation of counterfeit medicines in Ukraine. PhD’s thesis. Kharkiv, 283 p. Available at: https://dspace.nuph.edu.ua/bitstream/123456789/28560/12026%2010.pdf.
Verkhovna Rada Ukrainy. (1992). Zakon vid 19.11.1992 No. 2801-XII “Osnovy zakonodavstva Ukrainy pro okhoronu zdorovia”. Zakon.rada.gov.ua. Available at: https://zakon.rada.gov.ua/laws/show/2801-12#Text.
Verkhovna Rada Ukrainy. (1996). Zakon vid 04.04.1996 No. 123/96-ВР “Pro likarski zasoby”. Zakon. rada. gov. ua. Available at: https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80#Text.
Verkhovna Rada Ukrainy. (2007). Zakon vid 05.04.2007 “Pro osnovni zasady derzhavnoho nahliadu (kontroliu) u sferi hospodarskoi diialnosti”. Zakon.rada.gov.ua. Available at: https://zakon.rada.gov.ua/laws/show/877-16#Text.
Verkhovna Rada Ukrainy. (2011). Zakon vid 17.03.2011 No. 3166-VI “Pro tsentralni orhany vykonavchoi vlady”. Zakon.rada.gov.ua. Available at: https://zakon.rada.gov.ua/laws/show/3166-17#Text.
Kabinetu Ministriv Ukrainy. (2015). Postanova vid 12.08.2018 No. 647 “Pro zatverdzhennia Polozhennia pro Derzhavnu sluzhbu Ukrainy z likarskykh zasobiv ta kontroliu za narkotykamy”. Zakon.rada. gov. ua. Available at: https://zakon.rada.gov.ua/laws/show/647-2015-%D0%BF#Text.
Republic of Estonia. Agency of Medicines. Available at: https://ravimiamet.ee/en
Melnyk, R. S., Bevzenko, V. M. (2014). Zahalne administratyvne pravo : navch. posib. Kyiv, 376.
Surmin, Yu. P. ta in. (2010). Entsyklopedychnyi slovnyk z derzhavnoho upravlinnia / za red. Yu. V. Kovbasiuka, V. P. Troshchynskoho, Yu. P. Surmina. Kyiv : NADU, 820.
Dziundziuk, V. B. ta in. (2011). Publichne administruvannia v Ukraini : navch. posib. / zah. red. N. M. Meltiukhovoi. Kharkiv : KharRI NADU “Mahistr”, 256.
Sokolov, A. V. (2014). Functions of executive power and features as available public services. Derzhavne upravlinnia: udoskonalennia ta rozvytok. No. 3. Available at: http://www.dy.nayka.com.ua/?op=1&z=900.
Memorandum pro vzaiemorozuminnia shchodo spivrobitnytstva mizh Derzhavnoiu sluzhboiu Ukrainy z likarskykh zasobiv ta kontroliu za narkotykamy ta Natsionalnym ahentstvom sanitarnoho nahliadu Brazylii (ANVISA) vid 08.11.2013. Shchotyzhnevyk Apteka. 01.09.2014. Available at: https://www.apteka.ua/article/304591.
Memorandum pro vzaiemorozuminnia mizh Derzhavnoiu sluzhboiu Ukrainy z likarskykh zasobiv ta kontroliu za narkotykamy ta Natsionalnoiu ahentsiieiu z kontroliu yakosti likarskykh zasobiv ta produktiv kharchuvannia Respubliky Indoneziia u farmatsevtychnii sferi vid 14.11.2016. URL: Available at: https://zakon.rada.gov.ua/laws/show/360_001-16#Text.
Derzhliksluzhba ta Derzhavna ustanova “Vidkryti publichni finansy” pidpysaly Memorandum pro spivpratsiu. (2018). Liky v Ukraini. 15.02.2018. Available at: https://xn--h1adc2i.xn--j1amh/news/150218-9.html.
Derzhliksluzhba ta TsHZ pidpysaly memorandum pro vzaiemorozuminnia ta spivpratsiu. (2021). Shchotyzhnevyk Apteka. 10.02.2021. Available at: https://www.apteka.ua/article/583531.
Natsionalna akademiia nauk Ukrainy. (2021). Memorandum pro partnerstvo mizh Derzhavnoiu sluzhboiu Ukrainy z likarskykh zasobiv ta kontroliu za narkotykamy, Natsionalnoiu akademiieiu nauk Ukrainy ta NTK “Instytut monokrystaliv” NAN Ukrainy. 23.03.2021. Available at: https://www.nas.gov.ua/UA/Messages/Pages/View.aspx?MessageID=7640.
Pidpysano Memorandum pro spivpratsiu mizh Derzhpratsi ta Derzhliksluzhboiu 06 lypnia 2021. (2021). Available at: https://dsp.gov.ua/pidpysano-memorandum-pro-spivpratsiu-mizh-derzhpratsi-ta-derzhliksluzhboiu/.
Pidpysano Memorandum pro spivpratsiu z Derzhavnym kontsernom “Ukroboronprom”. (2022). The Pharma Media. 11.02.2022. Available at: https://thepharma.media/uk/news/28179-derzliksluzba-pidpisala-memorandum-z-derzavnim-koncernom-ukroboronprom-11022022.
Ministerstvo okhorony zdorovia Ukrainy. (2022). Nakaz vid 23.09.2022 No. 1724 “Pro zatverdzhennia Poriadku obminu informatsiieiu mizh Ministerstvom okhorony zdorovia Ukrainy, derzhavnym pidpryiemstvom “Derzhavnyi ekspertnyi tsentr Ministerstva okhorony zdorovia Ukrainy” ta Derzhavnoiu sluzhboiu Ukrainy z likarskykh zasobiv ta kontroliu za narkotykamy u sferi obihu likarskykh zasobiv ta medychnykh vyrobiv”. zakon.rada.gov.ua. Available at: https://zakon.rada.gov.ua/laws/show/z1208-22#n13.
Derzhavna sluzhba Ukrainy z likarskykh zasobiv ta kontroliu za narkotykamy. (2017). Memorandum pro spivpratsiu mizh Derzhavnoiu sluzhboiu Ukrainy z likarskykh zasobiv ta kontroliu za narkotykamy ta Natsionalnoiu politsiieiu Ukrainy. 03.07.2017. Zakon.rada.gov.ua. Available at: https://zakon.rada.gov.ua/rada/show/n0001878-17#Text.
Derzhliksluzhba ta SBU pidpysaly Memorandum pro spivpratsiu. (2019). Shchotyzhnevyk Apteka. 25.01.2019. Available at: https://www.apteka.ua/article/487386.
Verkhovna Rada Ukrainy. (1984). Zakon vid 07.12.1984 No. 8073-Х “Kodeks Ukrainy pro administratyvni pravoporushennia”. Zakon.rada.gov.ua. Available at: https://zakon.rada.gov.ua/laws/show/80732-10#Text.
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