High-tech pharmaceutical manufacturing in Ukraine: challenges of European integration

Authors

DOI:

https://doi.org/10.31617/zt.knute.2021(118)08

Keywords:

EU, Ukraine, European integration, pharmaceutical sector, industrial policy, strategy, pharmaceuticals, medical products, high-technologies, innovation.

Abstract

Background. The crisis COVID-19 pandemic has highlighted that EU have strategic dependencies, particularly in the most sensitive industrial ecosystems such as for health. Ukraine implements the policy of European economic integration and the development of the pharmaceutical sector must take into account both European considerations and national interests.
Analysis of recent researches and publications revealed that the crisis COVID-19 pandemic revealed pharmaceutical industry problems; that require further study for adequate reproduction of the best practices in Ukraine.
The aim of the article is to explore the EU experience, to define and justify the necessary policy measures for the development of pharmaceuticals in Ukraine in the context of European integration.
Materials and methods. The theoretical and methodological basis for writing the article was the works of domestic and foreign scholars on the outlines of an industrial policy for the pharmaceutical sector. The research was conducted using the methods of theoretical generalization, comparative analysis, analysis and synthesis, which made it possible to justify the need for changes in the management of high-tech pharmaceutical industries development in Ukraine.
Results. The regulations in force in Ukraine regulate legal relations in the pharmaceutical sector in the context of EU integration, but do not define the priorities of the sector and the measures to achieve them or the mechanisms for their implementation. Recommendations for Ukraine have been given, the implementation of which will accelerate the development of national high-tech pharmaceutical industries and related sectors of the economy taking into account changes in EU policy.
Conclusion. In Ukraine, first of all it is necessary to define the conceptual foundations of the strategy of development of the high-tech industry of pharmaceuticals and medical products, based on the modern challenges and threats, as well as global trends in the technology development; to build an effective decision making vertical on the implementation of industrial policy for the pharmaceutical sector, identify strategic priorities and evaluate the necessary funding, to introduce state support programs, introduce instruments to stimulate domestic demand for Ukrainian pharmaceutical and medical products, make changes to the public procurement system for the development of industry for national security purposes. Recommendations are proposed as to: improving the normative-legal and institutional principles of the development of pharmaceutical industry; strengthening the cooperation of the State, academic, educational, private sector and public; creating stable resources of funding programs and projects on the basis of public-private partnerships.

Author Biographies

Olena SALIKHOVA, State Institution «NASU Institute of Economics and Forecasting»

Doctor of Economics, Leading Researcher at the Modeling and Forecasting Department of Economic Development

Daria HONCHARENKO, Ministry of Economy of Ukraine

Chief Specialist at the Real Sector Development Department of the Main Department of the Real Economy Sector of the Directorate of Pricing Policy and Development of the Real Sector of Economy

References

Dorovs'kyj, O. V. (2015). Obg'runtuvannja vyboru strategii' rozvytku farma­cevtychnoi' galuzi Ukrai'ny [Justification of the choice of strategy for the development of the pharmaceutical industry of Ukraine] Extended abstract of Doctor's thesis. Harkiv [in Ukrainian].

Kostjuk, G., & Margitych, V. (2017). Pro nacional'nu strategiju zabezpechennja likamy v Ukrai'ni [On the national drug supply strategy in Ukraine]. Dzerkalo tyzhnja – Mirror of the week. Retrieved from https://zn.ua/ukr/promyshliennost/pro-nacionalnu-strategiyu-zabezpechennya-likami-v-ukrayini-_.html [in Ukrainian].

Sidenko, V. (2018). Pereformatuvannja jevropejs'koi' integracii': mozhlyvosti i ryzyky dlja asociacii' Ukrai'na-JeS [Reformatting European integration: opportunitiesand risks for the Ukraine-EU association]. Kyi'v: Zapovit [in Ukrainian].

Sektoral'na integracija Ukrai'ny do JeS: peredumovy, perspektyvy, vyklyky [Ukraine's sectoral integration into the EU: preconditions, prospects, challenges]. (2020). Kyi'v: Zapovit [in Ukrainian].

Pashkov, V. M. (2016). Pravove zabezpechennja implementacii' zakonodavstva JeS shhodo obigu likars'kyh zasobiv [Legal support for the implementation of EU legislation on the circulation of medicines]. Medychne pravo – Medical law, 2, 55-62 [in Ukrainian] https://doi.org/10.25040/medicallaw2016.02.055.

Nikitjuk, V., & Shaikina, T. (2019). Farmacevtychna galuz' Ukrai'ny – integracija v jevropejs'kyj ta svitovyj rynok chy tupcjuvannja na misci? [Ukraine's pharmaceutical industry – integration into the European and world markets or stamping on the same place?] Shhotyzhnevyk apteka – Weekly pharmacy, 1. Retrieved from https://www.apteka.ua/article/510294. [inUkrainian].

Vdovychenko, V., & Zosymenko, T. (2021). Pandenomika Jevropy: politychni, ekonomichni ta social'ni vyklyky vakcynuvannja vid COVID-19. Analitychna zapyska program Jevropejs'kyh studij ta Ekonomichnoi' dyplomatii' Rady zovnishn'oi' polityky «Ukrai'ns'ka pryzma» v ramkah proektu Instytucijnogo rozvytku analitychnyh centriv za pidtrymky Posol'stva Shvecii' v Ukrai'ni. Iniciatyvy vidkrytogo suspil'stva dlja Jevropy (OSIFE) ta Mizhnarodnogo fondu «Vidrodzhennja» [Pandenomics of Europe: political, economic and social challenges of COVID-19 vaccination. Analytical note of the programs of European Studies and Economic Diplomacy of the Foreign Policy Council «Ukrainian Prism» in the framework of the project of Institutional Development of analytical centers with the support of the Embassy of Sweden in Ukraine. Open Society Initiatives for Europe (OSIFE) and the International Foundation «Renaissance».]. Retrieved from https://elibrary.kubg.edu.ua/id/eprint/36672/1/V_Vdovychenko_PE_2021_FPMV.pdf [in Ukrainian].

Korablin, S. O. (2021). Derzhavne reguljuvannja jak chynnyk protydii' COVID-19 [State regulation as a factor in counteracting COVID-19]. Ekonomika Ukrai'ny – Ukraine economy, 7, 27-40. Retrieved from https://doi.org/10.15407/economyukr.2021.07.027 [in Ukrainian] https://doi.org/10.15407/economyukr.2021.07.027.

Commission communication to the Council and Parliament on the outlines of an industrial policy for the pharmaceutical sector in the European Community. COM (93) 718, 02.03.94. Retrieved from https://op.europa.eu/mt/publication-detail/-/publication/6af1ca21-939d-11e9-9369-01aa75ed71a1/language-en/format-PDF/source-search [in English].

Industrial policy and the pharmaceutical industry. The Proceedings of a Symposium held on 22nd June 1994, London/ Edited by Adrian Towse. Office of Health Economics. Retrieved from https://www.ohe.org/system/files/private/publications/217%20-%201995_Industrial_Policy_Towse_FULL.pdf [in English].

Industrial policy for the pharmaceutical sector. Debates 16 April 1996. Retrieved from https://www.europarl.europa.eu/doceo/document/CRE-4-1996-04-16-ITM-003_EN.html [in English].

Council Resolution designed to implement the outlines of an industrial policy in the pharmaceutical sector in the European Union. 1996. Retrieved from https://op.europa.eu/ga/publication-detail/-/publication/bf15f43c-6a8b-4953-8155-04fc004a1be3/language-en [in English].

Pharmaceutical Industry: A Strategic Sector for the European Economy. European Commission. Commission Staff Working Document. 2014. Retrieved from https://ec.europa.eu/growth/content/pharmaceutical-industry-strategic-sector-european-economy-0_en [in English].

Innovative Medicines Initiative. URL: https://www.imi.europa.eu [in English].

Salihova, O. B., & Goncharenko, D. O. (2020). Endogenizacija ekonomichnogo rozvytku cherez rozbudovu vysokotehnologichnyh farmacevtychnyh vyrobnyctv: dosvid Jevropy, uroky dlja Ukrai'ny [Endogenization of economic development through the development of high-tech pharmaceutical industries: the experience of Europe, lessons for Ukraine]. Biznes Inform – Business Inform, 2, 49-56. Retrieved from https://doi.org/10.32983/2222-4459-2020-2-49-56 [in Ukrainian] https://doi.org/10.32983/2222-4459-2020-2-49-56.

The State of U. S. Science and Engineering 2020. Retrieved from https://ncses.nsf.gov/pubs/nsb20201 [in English].

European Commission. Communication from the Commission. Guidelines on the Optimal and Rational Supply of Medicines to Avoid Shortages during the COVID-19 Outbreak. 8.4.2020, COM. 2272 Final. Brussels. Retrieved from https://ec.europa.eu/info/sites/default/files/communication-commission-guidelines-optimal-rational-supply-medicines-avoid.pdf [in English].

Affordable, accessible and safe medicines for all: the Commission presents a Pharmaceutical Strategy for Europe. Retrieved from https://ec.europa.eu/commission/presscorner/detail/en/ip_20_2173 [in English].

Updating the 2020 Industrial Strategy: towards a stronger Single Market for Europe's recovery. Retrieved from https://ec.europa.eu/commission/presscorner/detail/en/IP_21_1884 [in English].

Madner, V., Mayr, S., & Sauca, I.(2021).Analyse der rechtlichen Rahmenbedingungenfür Maßnahmen zur Steigerung von Versorgungssicherheit und Resilienz. Working Paper Reihe der AK Wien – Materialien zu Wirtschaft und Gesellschaft 217, Kammer für Arbeiter und Angestellte für Wien, Abteilung Wirtschaftswissenschaft und Statistik. Retrievedfrom https://ideas.repec.org/p/clr/mwugar/217.html [in English].

Homenko, V. M. (2008). Teoretychne obg'runtuvannja ta realizacija suchasnyh pryncypiv derzhavnogo upravlinnja farmacijeju v Ukrai'ni: abstract of dis. for the obtaining a scientific degree of Dr. of Pharm. S.: 15.00.01. Harkiv [in Ukrainian].

Projekt koncepcii' Derzhavnoi' cil'ovoi' programy «Rozvytok importozaminnyh vyrobnyctv v Ukrai'ni ta zamishhennja importovanyh likars'kyh zasobiv vitchyznjanymy, u tomu chysli biotehnologichnymy preparatamy ta vakcynamy na 2011-2021 roky» [Draft concept of the State target program «Development of import-substituting industries in Ukrainean dreplacement of imported drugs with domestic ones, includingbiotechnologicaldrugsandvaccinesfor2011-2021»]. Retrieved from https://www.apteka.ua/article/78579 [in Ukrainian].

Koncepcija rozvytku farmacevtychnoi' galuzi Ukrai'ny [The concept of development of the pharmaceutical industry of Ukraine]. Retrieved from https://www.apteka.ua/article/2231 [in Ukrainian].

Projekt Koncepcii' Derzhavnoi' cil'ovoi' programy stvorennja vitchyznjanyh imunobiologichnyh preparativ «Ukrai'ns'ka vakcyna» na 2011–2015 r.[Draft Concept of the State Target Program for the Development of Domestic Immunobiological Drugs «UkrainianVaccine» for 2011-2015]. Retrieved from https://www.apteka.ua/article/28692 [in Ukrainian].

Koncepcija rozvytku importozaminnyh vyrobnyctv – zagroza farmacevtychnij galuzi ta bezpeci naselennja Ukrai'ny [The concept of development of import-substituting industries is a threat to the pharmaceutical industry and the safety of the population of Ukraine. (2011). Interfaks – Interfax-Ukraine. Retrieved from https://ua.interfax.com.ua/news/press-release/68941.html [in Ukrainian].

MOZ rozrobljaje Koncepciju derzhavnoi' programy rozvytku importozaminnyh vyrobnyctv v Ukrai'ni [The Ministry of Health is developing the Concept of the state program for the development of import-substituting industries in Ukraine]. Retrieved from https://www.kmu.gov.ua/news/249097923 [in Ukrainian].

Pro shvalennja Koncepcii' Derzhavnoi' cil'ovoi' naukovo-tehnichnoi' programy stvorennja ta provedennja doklinichnyh vyprobuvan' vitchyznjanyh likars'kyh zasobiv dlja zabezpechennja ohorony zdorov'ja ljudyny ta zadovolennja potreb veterynarnoi' medycyny na 2011-2015 r. Rozporjadzhennja KMU vid 6 grudnja 2010 r. № 2245. [About approval of the Concept of the State target scientific and technical program of creation and carrying out preclinical trials of domestic medicines for ensuring human health care and satisfaction of needs of veterinary medicine for 2011-2015. Order of the Cabinet of Ministers of December 6, 2010 № 2245]. Retrieved from https://zakon.rada.gov.ua/laws/show/2245-2010-%D1%80#Text [in Ukrainian].

Derzhavna cil'ova naukovo-tehnichna programa shhodo rozroblennja novitnih tehnologij stvorennja vitchyznjanyh likars'kyh zasobiv dlja zabezpechennja ohorony zdorov’ja ljudyny ta zadovolennja potreb veterynarnoi' medycyny na 2011–2015 roky. Postanova KMU № 725 vid 22.06.2011 r. [The state target scientific and technical program for the development of the latest technologies for the creation of domestic medicines to ensure human health care and meet the needs of veterinary medicine for 2011-2015. Resolution of the Cabinet of Ministers of Ukraine № 725 of June 22, 2011] URL: https://zakon.rada.gov.ua/laws/show/725-2011-%D0%BF#Text [in Ukrainian].

Pidbyto pidsumky realizacii' Derzhavnoi' naukovo-tehnichnoi' programy rozroblennja novitnih tehnologij stvorennja vitchyznjanyh likiv u 2012 r. [The results of the implementation of the State scientific and technical program for the development of new technologies for the creation of domestic drugs in 2012 are summarized.] Retrieved from https://www.apteka.ua/article/201885 [in Ukrainian].

Pro zatverdzhennja Koncepcii' rozvytku farmacevtychnogo sektoru galuzi ohorony zdorov’ja Ukrai'ny na 2011-2020 roky: Nakaz MOZ № 769 vid 13.09.2010. [On approval of the Concept of development of the pharmaceutical sector of the healthcare branch of Ukraine for 2011-2020: Order of the Ministry of Health № 769 dated 13.09.2010]. Retrieved from https://zakononline.com.ua/documents/show/25438___539786 [in Ukrainian].

Pro zatverdzhennja Planu zahodiv shhodo vykonannja Koncepcii' rozvytku farma­cevtychnogo sektoru galuzi ohorony zdorov'ja Ukrai'ny na 2011–2020 rr. [On approval of the Action Plan for the implementation of the Concept of the pharmaceutical sector development of the healthcare branch of Ukraine for 2011–2020]. Retrieved from https://zakononline.com.ua/documents/show/56725___56725 [in Ukrainian].

Pro zatverdzhennja Derzhavnoi' programy stymuljuvannja ekonomiky dlja podolannja negatyvnyh naslidkiv, sprychynenyh obmezhuval'nymy zahodamy shhodo zapobigannja vynyknennju i poshyrennju gostroi' respiratornoi' hvoroby COVID-19, sprychynenoi' koronavirusom SARS-CoV-2, na 2020–2022 rr. Postanova KMU № 534 vid 27 travnja 2020 r. [On approval of the State Program of Economic Stimulation to overcome the negative consequences caused by restrictive measures to prevent the occurrence and spread of acute respiratory disease COVID‑19 caused by coronavirus SARS-CoV-2, for 2020-2022. Resolution of the Cabinet of Ministers of Ukraine № 534 of May 27, 2020.] Retrieved from zakon.rada.gov.ua/laws/show/534-2020-%D0%BF#Text [in Ukrainian].

Projekt rozporjadzhennja Kabinetu Ministriv Ukrai'ny «Pro shvalennja Koncepcii' Derzhavnoi' cil'ovoi' programy stvorennja ta rozvytku vnutrishn'ogo vyrobnyctva vysokojakisnyh likars'kyh zasobiv dlja profilaktyky i likuvannja osoblyvo nebezpechnyh infekcijnyh ta inshyh hvorob dlja zabezpechennja derzhavnyh potreb Ukrai'ny na 2021-2026 rr.» [Draft order of the Cabinet of Ministers of Ukraine «On approval of the Concept of the State target program for the creation and development of domestic production of high quality drugs for the prevention and treatment of particularly dangerous infectious and other diseases to meet the state needs of Ukraine for 2021-2026».]. Retrieved from https://moz.gov.ua [in Ukrainian].

Povidomlennja NAN Ukrai'ny. Zasidannja Prezydii' NAN Ukrai'ny 9 chervnja 2021 roku. [Draft order of the Cabinet of Ministers of Ukraine «On approval of the Concept of the State target program for the creation and development of domestic production of high quality drugs for the prevention and treatment of particularly dangerous infectious and other diseases to meet the state needs of Ukraine for 2021‑2026».]. Retrieved from https://www.nas.gov.ua/UA/Messages/Pages/View.aspx?MessageID=7891[in Ukrainian].

Pro zatverdzhennja Nacional'noi' ekonomichnoi' strategii' na period do 2030 roku. Postanova KMU № 179 vid 03 bereznja 2021 r.[On approval of the National Economic Strategy for the period up to 2030. Resolution of the Cabinet of Ministers of Ukraine № 179 of March 3, 2021]. Retrieved from https://www.kmu.gov.ua/npas/pro-zatverdzhennya-nacionalnoyi-eko-a179 [in Ukrainian].

Salihova, O. B., & Goncharenko, D. O. (2020). Polityka rozbudovy farma­cevtychnoi' industrii' v Nimechchyni: Uroky dlja Ukrai'ny [Polityka rozbudovy farmacevtychnoi' industrii' v Nimechchyni: Uroky dlja Ukrai'ny]. Ekonomika Ukrai'ny – Ukraineeconomy, 10, 63-86. DOI: 10.15407/economyukr.2020.10.063 [in Ukrainian] https://doi.org/10.15407/economyukr.2020.10.063.

Salihova, O. B., & Goncharenko, D. O. (2020). Polityka endogennogo rozvytku farmacevtyky v Kytai': uroky dlja Ukrai'ny [The policy of endogenous development of pharmaceuticals in China: lessons for Ukraine]. Ekonomika ta prognozuvannja – Economics and forecasting, 2,139-157. DOI: 10.15407/eip2020.02.139 [in Ukrainian] https://doi.org/10.15407/eip2020.02.139.

Salihova, O. B., & Goncharenko, D. O. (2020). Konceptual'ni zasady strategii' rozvytku vysokotehnologichnoi' industrii' likars'kyh zasobiv ta medychnyh vyrobiv v Ukrai'ni do 2030 r. [Conceptual bases of strategy of development of the high-tech industry of medicines and medical devices in Ukraine till 2030]. Biznes Inform – Business Inform, 7, 28-35. Retrieved from https://doi.org/10.32983/2222-4459-2020-7-28-35 [in Ukrainian] https://doi.org/10.32983/2222-4459-2020-7-28-35.

Salihova, О. B., & Goncharenko, D. O. (2020). Farmacevtyka Ukrai'ny: vid zalezhnosti do endogennogo rozvytku [Pharmaceuticals of Ukraine: from dependence to endogenous development]. Ekonomika ta prognozuvannja – Economics and forecasting, 4, 7-35. DOI: 10.15407/eip2020.04.007 [in Ukrainian] https://doi.org/10.15407/eip2020.04.007.

Published

2021-10-13

How to Cite

[1]
SALIKHOVA О. and HONCHARENKO Д. 2021. High-tech pharmaceutical manufacturing in Ukraine: challenges of European integration. Foreign trade: economics, finance, law. 118, 5 (Oct. 2021), 128–154. DOI:https://doi.org/10.31617/zt.knute.2021(118)08.

Issue

Section

INNOVATIVE ECONOMY