Investments in medicines as a direction of state policy: Administrative and legal regulation
Author(s): Liudmyla Nikolenko*, Anatolii Dietochka, Vadym Chalyk, Olga Sokolenko and Illia Skvirskyi
Abstract
Aim: The purpose of the article is investments in medicines as a direction of state policy: Administrative and legal regulation.
Methods: A collection of general scientific, special legal, and interdisciplinary methods of cognition form the methodological foundation of scientific research. These methods offer a thorough and methodical analysis of investments in the field of medicine as a direction of state policy and an object of administrative and legal regulation. The dialectical method was used to clarify the patterns of development of administrative and legal regulation of investments in the pharmaceutical sector, to identify the relationship between economic processes, state policy and legal influence in the sphere of circulation of medicines. It made it possible to examine the development of regulatory strategies in relation to martial law and European integration. In order to create a comprehensive understanding of the system of administrative and legal regulation, analysis and synthesis were employed to break down the intricate phenomenon of investment activity in the pharmaceutical industry into distinct components (regulatory and legal support, licensing procedures, control, and incentives).
Results: In the domain of healthcare and pharmaceutical activities, the article offers a thorough examination of investments made in the pharmaceutical industry as a key area of state policy. The features of the legal status of investment entities are identified, the mechanisms of state administration, licensing, state registration of medicines, quality control, and pharmacovigilance are described, and the content of administrative and legal regulation of investment processes in the pharmaceutical sector is disclosed. Analysis is done on international regulatory standards (European Union (EU), World Health Organization (WHO), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)) and the challenges associated with their application in Ukraine’s post-war rehabilitation and martial law legislation. It is demonstrated that in order to encourage investments in the manufacturing of essential medications, it is necessary to improve administrative processes, deregulate, digitize, and implement special regimes.
Conclusion: It is determined that the balance of public and private interests, the rule of law, proportionality, and transparency of public administration should serve as the foundation for an efficient model of administrative and legal regulation of investments in the field of medical. By putting the suggested areas of improvement into practice, the pharmaceutical business will become more appealing to investors, the state’s pharmaceutical security will be strengthened, and Ukraine’s healthcare system will continue to grow sustainably.