JOURNAL OF THE CZECH PHARMACEUTICAL SOCIETY AND THE SLOVAK PHARMACEUTICAL SOCIETY

Čes. slov. farm. 2022, 71(5):200-213 | DOI: 10.5817/CSF2022-5-200

Characteristics of development and dissemination of environmental management systems in the area of production of medicines in Ukraine

Victoria V. Zhurenko1,*, Viacheslav O. Lebedynets2
1 Department of Management and Economics of Pharmacy, Institute of Pharmacy Professionals, Qualification Improvement, National University of Pharmacy, Kharkiv, Ukraine
2 Institute of Pharmacy Professionals, Qualification Improvement, National University of Pharmacy, Kharkiv, Ukraine

The article presents the results of a study based on an expert survey of senior management and leading experts of enterprises for the production of medicines in Ukraine and typical problematic aspects of implementing environmental management systems (EMS). It was found that among the enterprises whose respondents took part in the survey, only 25% implemented EMS and passed the certification procedure following the requirements of ISO 14001. A significant problem identified is the lack of influential information tools and methodological developments for the implementation, operation, and benefits of EMS in pharmaceutical production, especially to ensure processes regarding the readiness of enterprises to respond to emergencies. Insufficient support was noted, particularly in regulatory and financial incentives, and no benefits could encourage more efficient greening of pharmaceutical production. The negative consequence is the lack of interest of small and medium enterprises in investing in new technologies and sustainable business practices to reduce environmental pressures. EMS should be implemented as a part of the overall management system of the enterprise to manage environmental aspects, meet mandatory legal requirements and voluntary commitments in accordance with the objectives and environmental policy of the enterprise, as well as to address risks and opportunities. It is important to note the urgency of developing theoretical and methodological principles of design, implementation, and further development of EMS to increase the environmental efficiency of the enterprise, greening in medicines production, and achieving sustainable development goals.

Keywords: environmental management system; EMS; EMAS; ISO 14001; environmental aspects; pharmaceutical company; production of medicines
Grants and funding:

The research was conducted in accordance with the research plan of NUPh on the topic «Quality management in the field of creation, production and circulation of drugs» (state registration number 0114U000950) and as a part of the PhD study «Development of methodology for implementing the environmental management system in domestic pharmaceutical companies».

Received: April 28, 2022; Accepted: September 15, 2022; Published: May 1, 2022  Show citation

ACS AIP APA ASA Harvard Chicago Chicago Notes IEEE ISO690 MLA NLM Turabian Vancouver
Zhurenko VV, Lebedynets VO. Characteristics of development and dissemination of environmental management systems in the area of production of medicines in Ukraine. Čes. slov. farm. 2022;71(5):200-213. doi: 10.5817/CSF2022-5-200.
Download citation

References

  1. Weir D. States reluctant to strengthen laws protecting the environment from war. https://ceobs.org/states-reluctant-to-strengthen-laws-protecting-the-environment- -from-war/ (08.03.2022).
  2. Law of Ukraine "On the Basic Principles (Strategy) of the State Environmental Policy of Ukraine for the period up to 2030" of 28.02.2019 № 2697-VIII. Voice of Ukraine № 62. https://zakon.rada.gov.ua/laws/show/2697-19#Text(07.09.2022).
  3. Di Noia A., Nicoletti G. ISO 14001 certification: benefits, costs and expectations for organization. Stud. Oeconomica Posnaniensia 2016; 4 (10), 94-109. doi:https://dx. doi.org/10.18559/SOEP.2016.10.7(07.09.2022.). Go to original source...
  4. Testa F., Boiral O., Iraldo F. Internalization of environmental practices and institutional complexity: can stakeholders pressures encourage greenwashing? J. Bus. Ethics. 2018; 147, 287-307. doi:https://doi.org/10.1007/s10551-015-2960-2. (22.08.2022). Go to original source...
  5. ISO Survey. https://www.iso.org/the-iso-survey.html, https://isotc.iso.org/livelink/livelink?func=ll&objId=18808772&objAction=browse&viewType=1(19.04.2022).
  6. EMAS Statistics & graphs. https://ec.europa.eu/environment/emas/emas_registrations/statistics_graphs_en.htm(19.04.2022).
  7. Testa F., Heras-Saizarbitoria I., Daddi T., Boiral O., Iraldo F. Public regulatory relief and the adoption of environmental management systems: A European survey. J. Environ. Plan. Manag. 2016; 59, 2231-2250. doi:https://doi.org/10.1080/09640568.2016.1139491(22.08.2022). Go to original source...
  8. Montobbio F., Solito I. Does the eco-management and audit scheme foster innovation in European firms? Bus. Strategy Environ. 2017; 27(1), 82-99. doi:https://doi. org/10.1002/bse.1986 Go to original source...
  9. Papagiannakis G., Voudouris I., Lioukas S., Kassinis G. Environmental management systems and environmental product innovation: The role of stakeholder engagement. Bus. Strategy Environ. 2019; 28(6), 939-950. doi:https://doi.org/10.1002/bse.2293 Go to original source...
  10. Fanasch P. Survival of the fittest: The impact of ecocertification and reputation on firm performance. Bus. Strategy Environ. 2019; 28(4), 611-628. doi:https://doi. org/10.1002/bse.2268 Go to original source...
  11. Wagner M. Global governance in new public environmental management: An international and intertemporal comparison of voluntary standards' impacts. Bus. Strategy Environ. 2019; 29(3), 1057-1073. doi:https://doi. org/10.1002/bse.2417 Go to original source...
  12. Nowicki P., Ćwiklicki M., Kafel P., Wojnarowska M. Credibility of certified environmental management systems: Results from focus group interviews, Environ. Impact Assess. Rev. 2021; 88. doi: https://doi.org/10.1016/j.eiar.2021.106556 Go to original source...
  13. Epstein M., Buhovac A., Elkington J., Leonard H. Making Sustainability Work: Best Practices in Managing and Measuring Corporate Social, Environmental, and Economic Impacts. 2017. doi:https://doi.org/ 10.4324/9781351276443 Go to original source...
  14. Herghiligiu I. V., Robu I., Pislaru M., Vilcu A., Asandului A. L., Avasilcai S., Balan C. Sustainable environmental management system integration and business performance: a balance assessment approach using fuzzy logic. Sustain. 2019; 11, 5311. doi:https://doi. org/10.3390/su11195311 Go to original source...
  15. Zhurenko V., Lebedinec V. Implementation of environmental management systems at pharmaceutical companies in Ukraine: problems and risks. Abstracts of the V International Scientific and Practical Conference "Quality management in education and industry: experience, problems and prospects ". Lviv: Pyramid 2021; 98-100. https://science.lpnu.ua/sites/default/files/attachments/2021/23330/importantdoc/tezyquality2021.pdf(22.08.2022).
  16. DIRECTIVE 2010/75/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of November 24 2010 on industrial emissions (integrated pollution prevention and control). http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0075&from=EN(22.08.2022).
  17. Law of Ukraine "On Environmental Impact Assessment (EIA)" of 23.05.17 № 2059-VIII. https://zakon.rada.gov.ua/laws/show/2059-19#Text
  18. Resolution of the Cabinet of Ministers of Ukraine "On approval of the Procedure for transfer of documentation for issuing an EIA opinion and financing of environmental impact assessment and the Procedure for maintaining the Unified Register of EIA" of 13.12.2017 № 1026. https://menr.gov.ua(14.07.2022).
  19. Resolution of the Cabinet of Ministers of Ukraine "On approval of the criteria by which the degree of risk from business activities is assessed" of 06.03.2019 № 182. https://zakon.rada.gov.ua/laws/show/182-2019-%D0%BF#- Text (14.07.2022).
  20. Permits and licenses. Ministry of Environmental Protection and Natural Resources of Ukraine. https://mepr.gov.ua/news/33099.html(14.04.2022).
  21. National standard of Ukraine. Environmental management systems. Requirements and guidelines for application (ISO 14001: 2015, IDT): DSTU ISO 14001: 2015 [To replace DSTU ISO 14001: 2015; Valid from 2016-07-01]. UkrNDNC, 2016, 30.
  22. Marcel J., Lira S., Salgado G. E., Beijo L. A. Characterization of evolution and dissemination of ISO 14001 in countries and economic sectors in Europe. J. Environ. Plan. Manag. 2018; 1166-1184. doi: https://doi.org/10.1080/09640568.2018.1479244 Go to original source...
  23. WORLD ECONOMIC OUTLOOK UPDATE "Rising Caseloads, a Disrupted Recovery, and Higher Inflation". INTERNATIONAL MONETARY FUND. 2022. https://www.imf.org/en/Publications/WEO/Issues/2022/01/25/world-economic-outlook-update-january-2022 (10.08. 2022).
  24. Lebedinec V. Methodology of formation of quality management systems at the enterprises on manufacture of medicines. The dissertation on competition of a scientific degree of the doctor of pharmaceutical sciences. NUPh, 2016. https://docplayer.net/67339750-Lebedinec-vyacheslav-oleksandrovich-metodologiya-formuvannya-sistem-upravlinnya-yakistyu-na-pidpriiemstvah-z-virobnictva-likarskih-zasobiv.html(22.08.2022).
  25. Electronic public procurement system "ProZorro". Top 5 popular questions about green public procurement. https://infobox.prozorro.org/articles/5-populyarnih-zapitan-pro-zeleni-publichni-zakupivli-ta-vidpovidi-na-nih-1(17.09.2021).




Czech and Slovak Pharmacy

Madam, Sir,
please be aware that the website on which you intend to enter, not the general public because it contains technical information about medicines, including advertisements relating to medicinal products. This information and communication professionals are solely under §2 of the Act n.40/1995 Coll. Is active persons authorized to prescribe or supply (hereinafter expert).
Take note that if you are not an expert, you run the risk of danger to their health or the health of other persons, if you the obtained information improperly understood or interpreted, and especially advertising which may be part of this site, or whether you used it for self-diagnosis or medical treatment, whether in relation to each other in person or in relation to others.

I declare:

  1. that I have met the above instruction
  2. I'm an expert within the meaning of the Act n.40/1995 Coll. the regulation of advertising, as amended, and I am aware of the risks that would be a person other than the expert input to these sites exhibited


No

Yes

If your statement is not true, please be aware
that brings the risk of danger to their health or the health of others.