International legal framework of healthcare regulation

Authors

  • Vladislav S. Malichenko Institute of Legislation and Comparative Law under the Government of the Russian Federation

DOI:

https://doi.org/10.21638/spbu14.2024.412

Abstract

Under the influence of economic globalization and demographic changes, healthcare challenges have gradually been integrated into the agenda of international intergovernmental organizations, emphasizing their importance in the socio-economic well-being of the population and sustainable development. Increase in the frequency of new infectious pandemics registration and other global systemic threats has influenced analysis of possible directions for the development of international legal regulation of the healthcare sector in the scientific literature and documents of international organizations. In the presented article, the author systematizes the main threats and challenges in the field of health protection and their role in rethinking the concept of human security. The author carried out a comprehensive analysis of global health and global health governance concept formation. The article systematizes the main actors of international relations involved in the regulation of healthcare. Summarizing doctrinal sources, a critical analysis of international healthcare law as a new branch of international law is presented. The article is based on international treaties, resolutions of international intergovernmental organizations, as well as documents of other actors of international relations were studied and scientific studies of national and foreign experts in international health regulation and international health relations. Based on the results of the study, a conclusion is presented on the formation of “international health law” as a new branch of international law. The author systematizes the main sources of “international health law”, as well as a list of the main international actors involved in the regulation of this area.

Keywords:

international health law, right to health, health protection, human security, global health governance, global health

Downloads

Download data is not yet available.
 

References

Библиография

Азходжаева, Р. А. 2008. Международно-правовое регулирование охраны здоровья в рамках ВТО. Дис. … канд. юрид. наук, Российский университет дружбы народов.

Бартенев, Д. Г. 2006. Право на охрану здоровья в международном праве. Дис. … канд. юрид. наук, Санкт-Петербургский государственный университет.

Беликова, К. М. 2019. «Действие патентного права Бразилии применительно к фармацевтическим продуктам: правовые проблемы и пути их решения до и после присоединения страны к ВТО». Право и политика 7: 1–12.

Белоусова, А. А. 2015. Право на здоровье в современном международном праве. Дис. … канд. юрид. наук, Российский университет дружбы народов.

Беляков, А. В. 2009. Международно-правовые проблемы обеспечения здравоохранения. Дис. … канд. юрид. наук, Институт государства и права РАН.

Берандзе, М. Р. 2010. Концепция транснационального права в международном праве. Дис. … канд. юрид. наук, Казанский государственный университет.

Борисова-Жарова, В. Г. 2008. Международно-правовые основы обеспечения права человека на здоровье. Дис. … канд. юрид. наук, Дипломатическая академия МИД РФ.

Велижанина, М. Ю. 2007. «Мягкое право»: его сущность и роль в регулировании международных отношений. Дис. … канд. юрид. наук, Дипломатическая академия МИД РФ.

Карташкин, В. А. 2022. «Устарело ли международное право: мифы и реальность». Государство и право 8: 136–146.

Коваленко, А. Ю. 2013. «Комплексные отрасли права на современном этапе развития системы российского права». Известия Иркутской государственной экономической академии 4: 1–27.

Колосов, Ю. М. 1974. Массовая информация и международное право. М.: Междунар. отношения.

Малинин, С. А. 1971. «О правотворческой деятельности межгосударственных организаций». Советский ежегодник международного права, 16–19. М.: Сов. Ассоц. междунар. права.

Маличенко, В. С. 2021a. «Международно-правовые механизмы противодействия чрезвычайным ситуациям в сфере здравоохранения». Право. Журнал Высшей школы экономики 1: 174–197.

Маличенко, В. С. 2021b. «Международно-правовые механизмы регулирования доступа к технологиям здравоохранения». Право. Журнал Высшей школы экономики 5: 256–285.

Маличенко, В. С. 2021c. «Формирование международного права здравоохранения». Московский журнал международного права 4: 6–20.

Рубанова, Н. А. 2010. «Медицинское право как новая отрасль права». Наука и образование: хозяйство и экономика; предпринимательство; право и управление 4: 86–88.

Сильченко, Н. П. 2012. Международно-правовые механизмы обеспечения права на охрану здоровья в контексте эпидемий, представляющих глобальную угрозу. Дис. … канд. юрид. наук, Дипломатическая академия МИД РФ.

Тиунов, О. И. 2013. «Предмет, система и принципы международного права окружающей среды». Журнал российского права 6: 66–79.

Тихомиров, Ю. А. 2002. «Глобализация: взаимовлияние внутреннего и международного права». Журнал российского права 11: 3–12.

Тихомиров, Ю. А. 2015. «Научная школа публичного права». Журнал российского права 9: 16–24.

Тихомиров, Ю. А. 2016. «Новые векторы регулирования — “другое” право?» Журнал российского права 4: 5–15.

Фельдман, Д. И. 1983. Система международного права. Казань: Изд-во Казан. ун-та.

Халафян, Р. М. 2012. «Концепция международного “мягкого права” в международно-правовой доктрине». Евразийский юридический журнал 2: 35–38.

Шумилов, В. М. 2015. «Концепция глобального права и глобальной нормативной системы». Современный юрист 3: 70–87.

Шумилов, В. М. 2017. «Глобальная нормативная система и ее составляющие». Государство и право 4: 72–78.

Belangera, M. 1989. “The future of international health legislation”. International Digest of Health Legislation 40 (1): 1–8.

Bell, J. A., J. B. Nuzzo. 2021. Global Health Security Index: Advancing Collective Action and Accountability amid Global Crisis. Дата обращения 1 января, 2024. https://www.nti.org/wp-content/uploads/2021/12/2021_GHSindexFullReport_Final.pdf

Boutros-Ghali B. 1992. An Agenda for Peace. New York. Дата обращения 12 ноября, 2024. https://digitallibrary.un.org/record/145749?ln=en&v=pdf.

Burci, G. L., ed. 2016. Global Health Law. Cheltenham: Edward Elgar Publ.

Chen, X., H. Li, D. E. Lucero-Prisno, A. S. Abdullah, J. Huang, C. Laurence, X. Liang, Z. Ma, Z. Mao, R. Ren, S. Wu, N. Wang, P. Wang, T. Wang, H. Yan, Y. Zou. 2020. “What is global health? Key concepts and clarification of misperceptions”. Global Health Research and Policy 5 (1): 1–8.

Dodgson, R., K. Lee, N. Drager. 2002. Global health governance: A conceptual review. London; Geneva: World Health Organization.

Evans, J. 2010. “Pandemics and national security”. Global Security Studies 1 (1): 100–109.

Fidler, D. P. 1996. “Globalization, international law, and emerging infectious diseases”. Emerging Infectious Diseases 2 (2): 77–84.

Fidler, D. P. 1997. “The globalization of public health: Emerging infectious diseases and international relations”. Indiana Journal of Global Legal Studies 1: 11–51.

Fluss, S. S. 1997. “International public health law: An overview”. Oxford Textbook of Public Health 1: 371–390.

Gostin, L. O. 2007. “A theory and definition of public health law”. Journal of Health Care Law and Policy 10: 3–41.

Gostin, L. O. 2014. Global Health Law. Cambridge: Harvard University Press.

Gostin, L. O., B. M. Meier. 2019. “Introducing global health law”. Journal of Law, Medicine & Ethics 47 (4): 788–793.

Gostin, L. O., A. L. Taylor 2008. “Global health law: A definition and grand challenges”. Public Health Ethics 1 (1): 53–63.

Hoffman, S. J., C. B. Cole. 2018. “Defining the global health system and systematically mapping its network of actors”. Globalization and Health 14: 1–19.

Kumar, M., A. Fatma, N. Bharti. 2022. “Access to medicines and medical equipment during COVID-19: Searching compatibility between the WTO and the WHO”. India Quarterly 1: 68–87.

Lee, K., A. Kamradt-Scott. 2014. “The multiple meanings of global health governance: A call for conceptual clarity”. Globalization and Health 10 (1): 1–10.

McInnes, C., K. Lee. 2006. “Health, security and foreign policy”. Review of international studies 32 (1): 5–23.

Meulenbelt, S. E., M. S. Nieuwenhuizen. 2015. “Non-state actors’ pursuit of CBRN weapons: From motivation to potential humanitarian consequences”. International Review of the Red Cross 97 (899): 831–858.

Mihajlov, V. S. 1989. “International health law: Current status and future prospects”. International Digest of Health Legislation 40 (1): 9–28.

Montgomery, J. R. 2000. “Time for a paradigm shift? Medical law in transition”. Current Legal Problems 2000. Ed. by M. Freeman, 363–408. Oxford: Oxford University Press.

Rosen, G. 2015. A history of public health. Baltimore: Johns Hopkins University Press.

Ruger, P. 2018. Global health justice and governance. Oxford: Oxford University Press.

Sekalala, S. 2017. Soft law and global health problems: Lessons from responses to HIV/AIDS, malaria and tuberculosis. Cambridge: Cambridge University Press.

Singh, S. K. 2019. “Infectious diseases national security and globalization”. World Affairs: The Journal of International Issues 23 (1): 10–23.

Taylor, A. L. 2004. “Governing the globalization of public health”. Journal of Law, Medicine & Ethics 32 (3): 500–508.

Teitelbaum, J. B., S. E. Wilensky. 2016. Essentials of health policy and law. Burlington: Jones & Bartlett Publ.

Tenni, B., H. V. J. Moir, B. Townsend, B. Kilic, A.-M. Farrell, T. Keegel, D. Gleeson. 2022. “What is the impact of intellectual property rules on access to medicines? A systematic review”. Globalization and Health 18 (1): 1–40.

Toebes, B. 2015. “International health law: An emerging field of public international law”. Indian Journal of International Law 55 (3): 299–328.

Vignes, C.-H. 1989. “The future of international health law: WHO perspectives”. International Digest of Health Legislation 40 (1): 16–19.

Yach, D., D. Bettcher. 1998. “The globalization of public health, I: Threats and opportunities”. American Journal of Public Health 88 (5): 735–744.

References

Azkhodzhaeva, R. A. 2008. International legal regulation of health protection within the WTO. PhD Thesis in Law, Rossiiskii universitet druzhby narodov. (In Russian)

Bartenev, D. G. 2006. The right to health protection in international law. Abstract of PhD Thesis in Law, Sankt-Peterburgskii gosudarstvennyi universitet. (In Russian)

Belangera, M. 1989. “The future of international health legislation”. International Digest of Health Legislation 40 (1): 1–8.

Belikova, K. M. 2019. “The effect of Brazilian Patent Law on pharmaceutical products: Legal issues and solutions before and after the country’s accession to the WTO”. Pravo i politika 7: 1–12. (In Russian)

Bell, J. A., J. B. Nuzzo. 2021. Global Health Security Index: Advancing Collective Action and Accountability amid Global Crisis. Accessed November 13, 2024. https://www.nti.org/wp-content/uploads/2021/12/2021_GHSindexFullReport_Final.pdf.

Belousova, A. A. 2015. The right to health in modern international law. PhD Thesis in Law, Rossiiskii universitet druzhby narodov. (In Russian)

Belyakov, A. V. 2009. International legal problems of ensuring health care. PhD Thesis in Law, Institut gosudarstva i prava RAN. (In Russian)

Berandze, M. R. 2010. The concept of transnational law in international law. PhD Thesis in Law, Kazanskii gosudarstvennyi universitet. (In Russian)

Borisova-Zharova, V. G. 2008. International legal foundations for ensuring the human right to health. PhD Thesis in Law, Diplomaticheskaia akademiia MID RF. (In Russian)

Boutros-Ghali B. 1992. An Agenda for Peace. New York. Accessed November 12, 2024. https://digitallibrary. un.org/record/145749?ln=en&v=pdf.

Burci, G. L., ed. 2016. Global Health Law. Cheltenham, Edward Elgar Publ.

Chen, X., H. Li, D. E. Lucero-Prisno, A. S. Abdullah, J. Huang, C. Laurence, X. Liang, Z. Ma, Z. Mao, R. Ren, S. Wu, N. Wang, P. Wang, T. Wang, H. Yan, Y. Zou. 2020. “What is global health? Key concepts and clarification of misperceptions”. Global health research and policy 5 (1): 1–8.

Dodgson, R., K. Lee, N. Drager. 2002. Global health governance: A conceptual review. London; Geneva, World Health Organization.

Evans, J. 2010. “Pandemics and national security”. Global Security Studies 1 (1): 100–109.

Feldman, D. I. 1983. The system of international law. Kazan, Izdatel’stvo Kazanskogo universiteta Publ. (In Russian)

Fidler, D. P. 1996. “Globalization, international law, and emerging infectious diseases”. Emerging Infectious diseases 2 (2): 77–84.

Fidler, D. P. 1997. “The globalization of public health: Emerging infectious diseases and international relations”. Indiana Journal of Global Legal Studies 1: 11–51.

Fluss, S. S. 1997. “International public health law: An overview”. Oxford Textbook of Public Health 1: 371–390.

Gostin, L. O. 2007. “A theory and definition of public health law”. Journal of Health Care Law and Policy 10: 3–41.

Gostin, L. O. 2014. Global Health Law. Cambridge, Harvard University Press.

Gostin, L. O., B. M. Meier. 2019. “Introducing global health law”. Journal of Law, Medicine & Ethics 47 (4): 788–793.

Gostin, L. O., A. L. Taylor. 2008. “Global health law: A definition and grand challenges”. Public Health Ethics 1 (1): 53–63.

Hoffman, S. J., С. B. Cole. 2018. “Defining the global health system and systematically mapping its network of actors”. Globalization and Health 14: 1–19.

Kartashkin, V. A. 2022. “Is international law outdated: Myths and reality”. Gosudarstvo i pravo 8: 136–146. (In Russian)

Khalafyan, R. M. 2012. “The concept of international ‘soft law’ in the international legal doctrine”. Evraziiskii iuridicheskii zhurnal 2: 35–38. (In Russian)

Kolosov, Yu. M. 1974. Mass information and international law. Moscow, Mezhdunarodnye otnosheniia Publ. (In Russian)

Kovalenko, A. Yu. 2013. “Complex branches of law at the present stage of development of the Russian law system”. Baikal Research Journal 4: 1–27. (In Russian)

Kumar, M., A. Fatma, N. Bharti. 2022. “Access to medicines and medical equipment during COVID-19: Searching compatibility between the WTO and the WHO”. India Quarterly 1: 68–87.

Lee, K., A. Kamradt-Scott. 2014. “The multiple meanings of global health governance: A call for conceptual clarity”. Globalization and Health 10 (1): 1–10.

Malichenko, V. S. 2021a. “International legal framework for health emergencies”. Pravo. Zhurnal Vysshei shkoly ekonomiki 1: 174–197. (In Russian)

Malichenko, V. S. 2021b. “International legal mechanisms for regulating access to health technologies”. Pravo. Zhurnal Vysshei shkoly ekonomiki 5: 256–285. (In Russian)

Malichenko, V. S. 2021c. “Shaping international health law”. Moskovskii zhurnal mezhdunarodnogo prava 4: 6–20. (In Russian)

Malinin, S. A. 1971. “On the law-making activity of interstate organizations”. Sovetskii ezhegodnik mezhdunarodnogo prava, 16–19. Moscow, Sovetskaia Assotsiatsiia mezhdunarodnogo prava Publ. (In Russian)

McInnes, C., K. Lee. 2006. “Health, security and foreign policy”. Review of International Studies 32 (1): 5–23.

Meulenbelt, S. E., M. S. Nieuwenhuizen. 2015. “Non-State actors’ pursuit of CBRN weapons: From motivation to potential humanitarian consequences”. International Review of the Red Cross 97 (899): 831–858.

Mihajlov, V. S. 1989. “International health law: Current status and future prospects”. International Digest of Health Legislation 40 (1): 9–28.

Montgomery, J. R. 2000. “Time for a paradigm shift? Medical law in transition”. Current Legal Problems 2000. Ed. by M. Freeman, 363–408. Oxford, Oxford University Press.

Rosen, G. 2015. A history of public health. Baltimore, Johns Hopkins University Press.

Rubanova, N. A. 2010. “Medical law as a new branch of law”. Nauka i obrazovanie: khoziaistvo i ekonomika; predprinimatel’stvo; pravo i upravlenie 4: 86–88. (In Russian)

Ruger, P. 2018. Global health justice and governance. Oxford, Oxford University Press.

Sekalala, S. 2017. Soft law and global health problems: Lessons from responses to HIV/AIDS, malaria and tuberculosis. Cambridge, Cambridge University Press.

Shumilov, V. M. 2015. “The concept of global law and the global regulatory system”. Sovremennyi iurist 3: 70–87. (In Russian)

Shumilov, V. M. 2017. “Global regulatory system and its components”. Gosudarstvo i pravo 4: 72–78. (In Russian)

Silchenko, N. P. 2012. International legal mechanisms for ensuring the right to health protection in the context of epidemics posing a global threat. PhD Thesis in Law, Diplomaticheskaia akademiia MID RF. (In Russian)

Singh, S. K. 2019. “Infectious diseases national security and globalization”. World Affairs: The Journal of International Issues 23 (1): 10–23.

Taylor, A. L. 2004. “Governing the globalization of public health”. Journal of Law, Medicine & Ethics 32 (3): 500–508.

Teitelbaum, J. B., S. E. Wilensky. 2023. Essentials of health policy and law. Burlington, Jones & Bartlett Publ.

Tenni, B., H. V. J. Moir, B. Townsend, B. Kilic, A.-M. Farrell, T. Keegel, D. Gleeson. 2022. “What is the impact of intellectual property rules on access to medicines? A systematic review”. Globalization and Health 18 (1): 1–40.

Tikhomirov, Yu. A. 2002. “Globalization: Interplay of domestic and international law”. Zhurnal rossiiskogo prava 11: 3–12. (In Russian)

Tikhomirov, Yu. A. 2015. “Scientific school of public law”. Zhurnal rossiiskogo prava 9: 16–24. (In Russian)

Tikhomirov, Yu. A. 2016. “New vectors of regulation — the ‘other’ right?” Zhurnal rossiiskogo prava 4: 5–15. (In Russian)

Tiunov, O. I. 2013. “Subject, system and principles of international environmental law”. Zhurnal rossiiskogo prava 6: 66–79. (In Russian)

Toebes, B. 2015. “International health law: An emerging field of public international law”. Indian Journal of International Law 55 (3): 299–328.

Velizhanina, M. Yu. 2007. “Soft law”: Its essence and role in regulating international relations. PhD Thesis in Law, Diplomaticheskaia akademiia MID RF. (In Russian)

Vignes, C.-H. 1989. “The future of international health law: WHO perspectives”. International Digest of Health Legislation 40 (1): 16–19.

Yach, D., D. Bettcher. 1998. “The globalization of public health, I: Threats and opportunities”. American Journal of Public Health 88 (5): 735–744.

Published

2024-12-28

How to Cite

Malichenko, V. S. (2024). International legal framework of healthcare regulation. Vestnik of Saint Petersburg University. Law, 15(4), 1098–1117. https://doi.org/10.21638/spbu14.2024.412

Issue

Section

Foreign and International Law