Advertising of medicines in Ukraine: An ethical and legal view
DOI:
https://doi.org/10.34069/AI/2023.64.04.37Palavras-chave:
morality, ethics, law, medicine, distribution, advertisement.Resumo
The modern course of Ukraine towards economic and political and legal rapprochement with European states involves the adoption of uniform rules in the field of healthcare. The objective of this article is to examine the ethical and legal aspects of advertising medicines in the context of Ukraine's alignment with European states and the adoption of uniform healthcare rules. The article employs a dialectical method to explore the correlation between ethical and legal components in medicine advertising. By analyzing domestic normative and legislative acts, there was establish methodological features of medicine advertising from the perspectives of ethics and law. The research also considers the broader context of international and national regulation of advertising in the pharmaceutical sector. The analysis of ethical and ethical-legal criteria enshrined in domestic regulations clarifies the general direction of modern state and non-state regulation of medicine advertising in Ukraine. This finding helps to provide a deeper understanding of the principles guiding advertising activities in the pharmaceutical sector.
Overall, the article contributes to the ongoing ethical and legal research on advertising regulation in the field of medicine circulation. It provides a foundation for the development of international and national regulations governing medicine advertising, emphasizing the importance of ethical considerations alongside legal frameworks.
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Referências
Aleks?e?ev, O. H., & Anishchenko, M. A. (2019). Legal professional restrictions of medical professionals under the legislation of Ukraine: problems and prospects. Pathologia, vol 16, No. 2(46), 288-292.
Alves, T. L., Lexchin, J., & Mintzes, B. (2019). Medicines Information and the Regulation of the Promotion of Pharmaceuticals. Science and Engineering Ethics, 25(4), 1167-1192.
Biryukova, N. V., Kharina, A. S., Nesterova, N. V., & Malakhovskiy, V. V. (2021). Historical aspects and features of deontology in preventive medicine. Journal of Advanced Pharmacy Education and Research, 11(3), 77-82.
Bozhenko, V. (2022). Tackling corruption in the health sector. Health Economics and Management Review, 3, pp. 32–39.
Code of ethics of pharmaceutical workers of Ukraine. (2010). Kharkiv: NFaU: Golden, Pages, 16 p.
Hegel, G. W. F. (1973). Aesthetics: in 4 volumes. M.: Art, 1968–1973. T. 4: Fragment from philosophical works. Articles. Letters, 676 p. https://www.marxists.org/reference/archive/hegel/works/ae/contents.htm
Hegel, G.W.F. (2000). Fundamentals of the philosophy of law, or natural law and state science. K.: Universe, 336 p. (In Ukranian)
Hrytsyuta, N. M. (2012). Advertising ethics as estimation landmark of modern society: monograph. K.: Institute of Journalism, 416 p. (In Ukranian)
Kabir, S. M. H., Maulan, S., Manaf, N. H. A., & Nasir, Z. W. (2021). Attitude of physicians and patients towards pharmaceutical promotion in healthcare: A qualitative study from ethical context. International Journal of Innovative Research and Publications, 1(1), 1-11.
Kodinets, A. O., Doroshenko, O. F., Volynets, I. P., Dorozhko, G. K., Petrenko, V. O., & Biletskyi, V. V. (2022). Protection against unfair advertising on the medicine market in the context of the COVID-19 pandemic. Medical perspectives, 27(4), 231-238. (In Ukranian)
Olkhovska, A. B. (2019). Theoretical and scientific-applied principles of improving marketing communications in the system of promotion of medicinal products in Ukraine (dissertation. ... Dr. Pharm. Sciences: Speciality "Medicine technology, organization of pharmaceutical business and forensic pharmacy"). National Pharmaceutical University, Kharkiv, 638 p. (In Ukranian)
Pasechnyk, O. V. (2015). Integration and legal regulation of circulation of medicinal products in the European Union (dissertation ... PhD in Law "International Law"). National "Odesa Law Academy" University, Odesa, 200 p. (In Ukranian)
Pashkov, V. M., & Olefir, A. O. (2017). Foreign experience of legal regulation of medicine advertising. Journal of the Kyiv University of Law, 1, p. 129-135. (In Ukranian)
Pashkov, V., Olefir, A., & Bytyak, Y. (2017). Legal features of the drug advertising legal issues regarding the advertising of medicinal products. Medical News, LXX(1), 133-138.
Schenker, Y., Arnold, R., & London, A. (2014). The Ethics of Advertising for Health Care Services. The American Journal of Bioethics, 14(3), 34-43.
Shemshuchenka, Yu. S. (red.). (2007). Big encyclopedic legal dictionary. K.: Yuridichna Dumka, 485-671.
Solovyov, O. S. (2018). Scientific-practical and theoretical justification of the system of pharmaceutical law enforcement measures in the sphere of circulation, promotion of medicinal products and parapharmaceutical products (Author's abstract. dissertation ... Dr. Pharm. Sciences: speciality "Medicine technology, organization of pharmaceutical business and forensic pharmacy"). National Pharmaceutical University, Kharkiv, 44 p. (In Ukranian)
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Terzi, O. O., Lyakhova, N. O., & Pluzhnikova, T. V. (2019). Legal and ethical principles of public health. Bulletin of social hygiene and health care organization of Ukraine, 3(81), 84-90. (In Ukranian)
Yevhutych, I. M. (2017). Morality and law in the system of social ideas and their place and role in the activities of the National Police of Ukraine: monograph. Lviv: LvDUVS, 212 p. (In Ukranian)
Yurkovska, L. G., Krasnov, V. V., & Ubogov, S. G. (2018). Correlation between law and morality as social regulators of the pharmaceutical sector in Ukraine. A collection of scientific works of the employees of the P. L. Shupyk NMAPO. K., 32, p. 330–340. (In Ukranian)
Legal sources
Decree No. 1155-?. Communication Strategy for the European Integration of Ukraine for the period up to 2026, of the Cabinet of Ministers of Ukraine of December 9, 2022 URL: https://zakon.rada.gov.ua/laws/show/1155-2022-% D1%80#Text
Decree No. 1617-?. Action Plan for the implementation of the Human Development Strategy for 2021–2023. Cabinet of Ministers of Ukraine of December 9, 2021 URL: https://zakon.rada.gov.ua/laws/show/1617-2021-% D1%80#Text.
Decree No. 480-?. Action Plan aimed at obtaining support for granting Ukraine the status of a candidate member of the European Union. Cabinet of Ministers of Ukraine dated June 17, 2022 URL: https://zakon.rada.gov.ua/laws/show/480- 2022-%D1%80#Text.
Decree of the President of Ukraine No. 369/2021. The Decision of the National Security and Defense Council of Ukraine "On the state of the national healthcare system and urgent measures to provide citizens of Ukraine with medical care" dated July 30, 2021, put into effect by the dated August 18, 2021 URL: https://zakon.rada.gov.ua/laws/show/n0052525-21#Text
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use https://acortar.link/k1I6tk
ICC Constitution (2018). ICC Advertising and Marketing Communications Code URL: https://acortar.link/iSiu3O
IFPMA (2019). Code of Practice 2019 (Ethos) URL: https://aipm.org.ua/wp-content/uploads/2019/05/IFPMA_Code_of_Practice_2019.pdf
Law of Ukraine 123/96-?? "On Medicinal Products" dated April 4, 1996. URL: https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80#Text.
Law of Ukraine No. 2469 "On Medicinal Products" dated July 28, 2022. URL: https://zakon.rada.gov.ua/laws/show/2469-20#Text.
Law of Ukraine No. 270/96-VR. On advertising from July 3, 1996 https://acortar.link/PS1xP2
Law of Ukraine No. 2801-XII " Fundamentals of Ukrainian Legislation on Health Care" dated November 19, 1992. URL: https://zakon.rada.gov.ua/laws/show/2801-12#Text].
Law of Ukraine No. 30. "On Protection of Consumer Rights" dated May 12, 1991 URL: https://zakon.rada.gov.ua/laws/show/1023-12#Text].
Order No. 870. Guideline "Medicines. Proper Promotion Practice. Standardization of MHU 42-1.2:2013", of the Ministry of Health of Ukraine dated October 9, 2013. URL: https://zakon.rada.gov.ua/rada/show/v0870282-13#Text.
Resolution No. 929 "On Approval of the License Conditions for the Implementation of Economic Activities in the Production of Medicines, Wholesale and Retail Trade in Medicines, Import of Medicines (excluding active pharmaceutical ingredients)" of the Cabinet of Ministers of Ukraine dated November 30, 2016. URL: https://zakon.rada.gov.ua/laws/show/929-2016-%D0%BF#Text.
World Health Organization (1988). Ethical Criteria for Medicinal Drug Promotion. May 13, 1988 URL: https://apps.who.int/iris/handle/10665/38125.pdf
Alves, T. L., Lexchin, J., & Mintzes, B. (2019). Medicines Information and the Regulation of the Promotion of Pharmaceuticals. Science and Engineering Ethics, 25(4), 1167-1192.
Biryukova, N. V., Kharina, A. S., Nesterova, N. V., & Malakhovskiy, V. V. (2021). Historical aspects and features of deontology in preventive medicine. Journal of Advanced Pharmacy Education and Research, 11(3), 77-82.
Bozhenko, V. (2022). Tackling corruption in the health sector. Health Economics and Management Review, 3, pp. 32–39.
Code of ethics of pharmaceutical workers of Ukraine. (2010). Kharkiv: NFaU: Golden, Pages, 16 p.
Hegel, G. W. F. (1973). Aesthetics: in 4 volumes. M.: Art, 1968–1973. T. 4: Fragment from philosophical works. Articles. Letters, 676 p. https://www.marxists.org/reference/archive/hegel/works/ae/contents.htm
Hegel, G.W.F. (2000). Fundamentals of the philosophy of law, or natural law and state science. K.: Universe, 336 p. (In Ukranian)
Hrytsyuta, N. M. (2012). Advertising ethics as estimation landmark of modern society: monograph. K.: Institute of Journalism, 416 p. (In Ukranian)
Kabir, S. M. H., Maulan, S., Manaf, N. H. A., & Nasir, Z. W. (2021). Attitude of physicians and patients towards pharmaceutical promotion in healthcare: A qualitative study from ethical context. International Journal of Innovative Research and Publications, 1(1), 1-11.
Kodinets, A. O., Doroshenko, O. F., Volynets, I. P., Dorozhko, G. K., Petrenko, V. O., & Biletskyi, V. V. (2022). Protection against unfair advertising on the medicine market in the context of the COVID-19 pandemic. Medical perspectives, 27(4), 231-238. (In Ukranian)
Olkhovska, A. B. (2019). Theoretical and scientific-applied principles of improving marketing communications in the system of promotion of medicinal products in Ukraine (dissertation. ... Dr. Pharm. Sciences: Speciality "Medicine technology, organization of pharmaceutical business and forensic pharmacy"). National Pharmaceutical University, Kharkiv, 638 p. (In Ukranian)
Pasechnyk, O. V. (2015). Integration and legal regulation of circulation of medicinal products in the European Union (dissertation ... PhD in Law "International Law"). National "Odesa Law Academy" University, Odesa, 200 p. (In Ukranian)
Pashkov, V. M., & Olefir, A. O. (2017). Foreign experience of legal regulation of medicine advertising. Journal of the Kyiv University of Law, 1, p. 129-135. (In Ukranian)
Pashkov, V., Olefir, A., & Bytyak, Y. (2017). Legal features of the drug advertising legal issues regarding the advertising of medicinal products. Medical News, LXX(1), 133-138.
Schenker, Y., Arnold, R., & London, A. (2014). The Ethics of Advertising for Health Care Services. The American Journal of Bioethics, 14(3), 34-43.
Shemshuchenka, Yu. S. (red.). (2007). Big encyclopedic legal dictionary. K.: Yuridichna Dumka, 485-671.
Solovyov, O. S. (2018). Scientific-practical and theoretical justification of the system of pharmaceutical law enforcement measures in the sphere of circulation, promotion of medicinal products and parapharmaceutical products (Author's abstract. dissertation ... Dr. Pharm. Sciences: speciality "Medicine technology, organization of pharmaceutical business and forensic pharmacy"). National Pharmaceutical University, Kharkiv, 44 p. (In Ukranian)
Statista Health Market Outlook. (2023). Pharmaceuticals – Market data analysis & forecasts. URL: https://www.statista.com/study/123522/pharmaceuticals-report/
Strelchenko, O. H. (2020). Public administration of the sphere of medicine circulation: administrative and legal research: monograph. Kyiv: NAVS, 442 p. (In Ukranian)
Strelchenko, O. H. (2019). Regulation of the sphere of medicinal products circulation in Ukraine: administrative and legal research: monograph. Kyiv: "Kafedra" Publishing Center, 400 p. (In Ukranian)
Terzi, O. O., Lyakhova, N. O., & Pluzhnikova, T. V. (2019). Legal and ethical principles of public health. Bulletin of social hygiene and health care organization of Ukraine, 3(81), 84-90. (In Ukranian)
Yevhutych, I. M. (2017). Morality and law in the system of social ideas and their place and role in the activities of the National Police of Ukraine: monograph. Lviv: LvDUVS, 212 p. (In Ukranian)
Yurkovska, L. G., Krasnov, V. V., & Ubogov, S. G. (2018). Correlation between law and morality as social regulators of the pharmaceutical sector in Ukraine. A collection of scientific works of the employees of the P. L. Shupyk NMAPO. K., 32, p. 330–340. (In Ukranian)
Legal sources
Decree No. 1155-?. Communication Strategy for the European Integration of Ukraine for the period up to 2026, of the Cabinet of Ministers of Ukraine of December 9, 2022 URL: https://zakon.rada.gov.ua/laws/show/1155-2022-% D1%80#Text
Decree No. 1617-?. Action Plan for the implementation of the Human Development Strategy for 2021–2023. Cabinet of Ministers of Ukraine of December 9, 2021 URL: https://zakon.rada.gov.ua/laws/show/1617-2021-% D1%80#Text.
Decree No. 480-?. Action Plan aimed at obtaining support for granting Ukraine the status of a candidate member of the European Union. Cabinet of Ministers of Ukraine dated June 17, 2022 URL: https://zakon.rada.gov.ua/laws/show/480- 2022-%D1%80#Text.
Decree of the President of Ukraine No. 369/2021. The Decision of the National Security and Defense Council of Ukraine "On the state of the national healthcare system and urgent measures to provide citizens of Ukraine with medical care" dated July 30, 2021, put into effect by the dated August 18, 2021 URL: https://zakon.rada.gov.ua/laws/show/n0052525-21#Text
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use https://acortar.link/k1I6tk
ICC Constitution (2018). ICC Advertising and Marketing Communications Code URL: https://acortar.link/iSiu3O
IFPMA (2019). Code of Practice 2019 (Ethos) URL: https://aipm.org.ua/wp-content/uploads/2019/05/IFPMA_Code_of_Practice_2019.pdf
Law of Ukraine 123/96-?? "On Medicinal Products" dated April 4, 1996. URL: https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80#Text.
Law of Ukraine No. 2469 "On Medicinal Products" dated July 28, 2022. URL: https://zakon.rada.gov.ua/laws/show/2469-20#Text.
Law of Ukraine No. 270/96-VR. On advertising from July 3, 1996 https://acortar.link/PS1xP2
Law of Ukraine No. 2801-XII " Fundamentals of Ukrainian Legislation on Health Care" dated November 19, 1992. URL: https://zakon.rada.gov.ua/laws/show/2801-12#Text].
Law of Ukraine No. 30. "On Protection of Consumer Rights" dated May 12, 1991 URL: https://zakon.rada.gov.ua/laws/show/1023-12#Text].
Order No. 870. Guideline "Medicines. Proper Promotion Practice. Standardization of MHU 42-1.2:2013", of the Ministry of Health of Ukraine dated October 9, 2013. URL: https://zakon.rada.gov.ua/rada/show/v0870282-13#Text.
Resolution No. 929 "On Approval of the License Conditions for the Implementation of Economic Activities in the Production of Medicines, Wholesale and Retail Trade in Medicines, Import of Medicines (excluding active pharmaceutical ingredients)" of the Cabinet of Ministers of Ukraine dated November 30, 2016. URL: https://zakon.rada.gov.ua/laws/show/929-2016-%D0%BF#Text.
World Health Organization (1988). Ethical Criteria for Medicinal Drug Promotion. May 13, 1988 URL: https://apps.who.int/iris/handle/10665/38125.pdf
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Publicado
2023-05-30
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Pokataev, P., Bodnarchuk, O., Hryshyna, T., Korolkov, V., & Demianchuk, Y. (2023). Advertising of medicines in Ukraine: An ethical and legal view. Amazonia Investiga, 12(64), 348–360. https://doi.org/10.34069/AI/2023.64.04.37
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