SYSTEMIC MEASURES FOR ENSURING THE SAFETY OF PAEDIATRIC MEDICINES: LEGAL ASPECTS AND INTERNATIONAL PRACTICE

Abstract

The article is devoted to the study of legal aspects of ensuring the quality and safety of pediatric medicines in the context of increasing risks of off-label use and insufficient national regulation. The subject of analysis is the legal regulation of prescribing medicines to children, while the aim is to identify gaps in the current legislation and to develop proposals for its improvement. The relevance of the topic is conditioned by tragic cases of the use of substandard medicines in Uzbekistan, including mass poisonings, which demonstrated the vulnerability of the control system and the necessity of establishing special regulatory rules. The methodological basis of the study consists of comparative-legal, formal-legal, and systemic approaches, which made it possible to compare the experience of the European Union, the Russian Federation, and the United States with national realities. The study established that in the EU the development and implementation of the Pediatric Investigation Plan have reduced the prevalence of off-label practices and stimulated the creation of pediatric formulations, while in the USA and Russia the key role is played by the institution of parental informed consent, which redistributes legal liability and ensures the protection of the child’s rights. The practical significance of the research lies in the possibility of using the conclusions to improve the legislation of the Republic of Uzbekistan, including the introduction of mandatory written parental consent for off-label prescriptions, the creation of legal incentives for pharmaceutical companies, and the adaptation of international approaches in the field of pediatric pharmacotherapy. The final conclusion is that the national legal system requires comprehensive modernization aimed at balancing the interests of the child, healthcare professionals, and the state.