Medicinal products as an object of commercial, civil and administrative legal relations: International standards and ways of improvement
Author(s): Olesia Volodyvyrivna Marchenko*, Olesia Denysivna Marchenko, Viktor Bohun, Oleh Posykaliuk and Artem Pytomets
Abstract
Aim: The purpose of the article is medicinal products as an object of economic, civil and administrative legal relations: International standards and ways of improvement.
Methods: The methodological basis of the study is a set of general scientific, special legal and interdisciplinary approaches that provide a comprehensive understanding of the legal nature of medicines as an object of economic, civil and administrative legal relations, as well as an analysis of international standards and national practice of legal regulation in this area.
Results: The article provides a comprehensive analysis of the legal nature of medicines as an object of economic, civil and administrative legal relations. The features of the legal regime of medicines are revealed, taking into account their social significance, increased requirements for quality, safety and effectiveness. International standards of legal regulation of the circulation of medicines are analyzed, in particular, acts of the European Union (EU), recommendations of the World Health Organization (WHO) and the practice of the European Medicines Agency (EMA). The key problems of the national legislation of Ukraine in this area are identified and ways of its improvement are proposed, taking into account European integration processes.
Conclusion: Medicines are a complex and multifaceted object of legal regulation, combining elements of civil, economic and administrative legal relations. Their special legal regime is due to their social significance and the need to ensure a high level of protection of human rights in the field of healthcare. Harmonization of national legislation with international standards is a key factor in improving the legal regulation of the circulation of medicines and ensuring the effective functioning of the pharmaceutical market of Ukraine.