On the need to improve the legislation on laboratory animals

Abstract

The authors have analyzed international experience in creating legal documents regulating the use of animals for scientific purposes. Topical issues related to the use of laboratory animals for scientific purposes in the Russian Federation, including for the purpose of preclinical studies on the efficacy and safety of new medicines, are discussed. The negative effects of the lack a clear and consistent legal framework for the organization and limits of the use of laboratory animals for research purposes in the Russian Federation are identified. Particular attention is paid to the issue of bioethics, the principles of ethical expertise of research activities involving laboratory animals and the issues of bioethical committees activities. The basic directions of perfection of normative-legal acts and methodological documents in the field of organization and limits of the use of laboratory animals for research purposes are proposed.

Keywords

• доклинические исследования лекарственных средств
• надлежащая лабораторная практика
• лабораторные животные
• этическая экспертиза
• законодательное регулирование
• нормативные документы
• preclinical studies
• good laboratory practice
• laboratory animals
• ethical expertise
• regulations
• legislative control