Research Institute of Legal Expertise and Comprehensive Research

2025

Full text Open access: Hybrid Metadata (CSL-JSON)
DOI 10.17803/1994-1471.2025.179.10.105-117
Data confidence 70 medium
How this score is calculated

It is built from checkable properties of the record itself: whether the article has a DOI, how many independent sources confirmed its data, whether the required fields are filled in, and how recent the latest confirmation is. Disagreement between sources and a missing identifier lower it. A value of 80 or above means the record was published without further checking; 60 to 79 means it is published at reduced confidence, with a manual check advisable. A record verified by an editor by hand is never pushed below 90 by a recalculation. This scores our data about the article, not the article itself.

Abstract

Various sources have raised concerns about patent holders — drug manufacturers — regarding the identification of abuses of exclusive rights, which lead to restricted availability of these highly socially significant products. This situation has worsened in our country in recent years. The greatest concern is the mass cancellation of clinical trials by many foreign pharmaceutical companies in our country starting in 2022, while maintaining their patent activity. Thus, there is a risk of creating conditions under which innovative drugs will no longer be supplied to our country in the coming years, but legal mechanisms for patent protection will be used to prevent the release of their generic equivalents. This situation cannot be considered acceptable. The legal mechanisms enshrined in Russian legislation (compulsory licensing, etc.) are insufficient to effectively resolve emerging problems. Considering this, comprehensive measures are needed to modernize the legal framework for state policy in terms of achieving accessibility of healthcare products. The aim of the study is to analyze the possibility of introducing a special legal regime for the implementation of intellectual property rights in the field of healthcare, including effective legal mechanisms for achieving a balance between private and public interests that do not contradict the international obligations accepted by the Russian Federation. The paper substantiates the need to introduce a special legal regime for the implementation of intellectual property rights in the field of healthcare. It specifies the main features of legal regimes and proposes a definition for the considered special legal regime. The legal principles and necessary directions for modernizing the legal regulation system in this area are highlighted separately