Organizational Forms of International Legal Interstate Cooperation on the Evaluation of Quality, Efficiency and Safety of Medicines

The article examines the ongoing changes in interstate cooperation on the assessment of the main universal characteristics of medicines (their quality, effectiveness and safety, traditionally studied during expertise in many countries and regions) in the context of the ongoing transformation of the interstate international system. The accumulated changes in the interstate international system and the tendency to increase the activity of cooperation between States have led to the emergence of new organizational forms of their interaction. Taking into account the tendency identified by scientists towards attempts to devalue the international legal system, a theoretical understanding of the emerging organizational forms of international legal interstate cooperation is required in order to provide legal means to ensure it, reducing the risks of participation in them and guaranteeing the most effective legal regulation of international relations and interstate expert cooperation. The sphere of drug circulation is interest for research, since after the COVID-19 pandemic, there has been an intensification of interstate cooperation in this area, a rethinking of existing and a search for new forms of interaction between states. On the basis of dialectical, formal and logical methods, a systematic approach and the method of comparative jurisprudence, the existing organizational forms of international legal cooperation between states on the assessment of the above-mentioned characteristics of medicines are investigated. The cases of unilateral acceptance by states of obligations related to the application of the requirements of third countries, international organizations or non-institutionalized platforms, bilateral and multilateral interstate cooperation, including the creation of international organizations, including integration, and international platforms, as well as cooperation of international integration associations, are considered in the field of drug circulation. Based on the results of the study, the experience of creating organizational forms of international legal cooperation between states and international integration associations on the assessment of the quality, effectiveness and safety of medicines is summarized, their classification is proposed, their pros and cons are considered, development trends, institutionalization options and new organizational forms of international legal interstate cooperation on these issues are identified. The results of the study can be useful in preparing proposals for initiating international legal interstate cooperation and choosing its optimal organizational form.

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Publication Details

Journal
Journal of Foreign Legislation and Comparative Law
Published
2025-01-01
DOI
https://doi.org/10.61205/s199132220034171-4
Primary Topic
Pharmaceutical Economics and Policy
Type
article
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article

Organizational Forms of International Legal Interstate Cooperation on the Evaluation of Quality, Efficiency and Safety of Medicines

Anna Kravchuk
Journal of Foreign Legislation and Comparative Law
Pharmaceutical Economics and Policy
article

Organizational Forms of International Legal Interstate Cooperation on the Evaluation of Quality, Efficiency and Safety of Medicines

Anna Kravchuk
article en

Abstract

The article examines the ongoing changes in interstate cooperation on the assessment of the main universal characteristics of medicines (their quality, effectiveness and safety, traditionally studied during expertise in many countries and regions) in the context of the ongoing transformation of the interstate international system. The accumulated changes in the interstate international system and the tendency to increase the activity of cooperation between States have led to the emergence of new organizational forms of their interaction. Taking into account the tendency identified by scientists towards attempts to devalue the international legal system, a theoretical understanding of the emerging organizational forms of international legal interstate cooperation is required in order to provide legal means to ensure it, reducing the risks of participation in them and guaranteeing the most effective legal regulation of international relations and interstate expert cooperation. The sphere of drug circulation is interest for research, since after the COVID-19 pandemic, there has been an intensification of interstate cooperation in this area, a rethinking of existing and a search for new forms of interaction between states. On the basis of dialectical, formal and logical methods, a systematic approach and the method of comparative jurisprudence, the existing organizational forms of international legal cooperation between states on the assessment of the above-mentioned characteristics of medicines are investigated. The cases of unilateral acceptance by states of obligations related to the application of the requirements of third countries, international organizations or non-institutionalized platforms, bilateral and multilateral interstate cooperation, including the creation of international organizations, including integration, and international platforms, as well as cooperation of international integration associations, are considered in the field of drug circulation. Based on the results of the study, the experience of creating organizational forms of international legal cooperation between states and international integration associations on the assessment of the quality, effectiveness and safety of medicines is summarized, their classification is proposed, their pros and cons are considered, development trends, institutionalization options and new organizational forms of international legal interstate cooperation on these issues are identified. The results of the study can be useful in preparing proposals for initiating international legal interstate cooperation and choosing its optimal organizational form.

Journal of Foreign Legislation and Comparative LawVol. 21(3)
The Institute of Legislation and Comparative Law under the Government of the Russian Federation (RU)
Openalex Percentile: Top 67%
Pharmaceutical Economics and Policy
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