Research Institute of Legal Expertise and Comprehensive Research

2025

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DOI 10.17803/1994-1471.2025.179.10.105-117
Достоверность данных 70 средняя
Как считается эта оценка

Складывается из проверяемых признаков самой записи: есть ли у статьи DOI, сколько независимых источников подтвердили её данные, заполнены ли обязательные поля и насколько свежо последнее подтверждение. Снижают оценку расхождения между источниками и отсутствие идентификатора. Значение от 80 означает, что запись опубликована без дополнительной проверки; от 60 до 79 — что она опубликована с пониженной достоверностью и ручная проверка желательна. Запись, выверенную редактором вручную, пересчёт не опускает ниже 90. Это оценка наших данных о статье, а не оценка самой статьи.

Аннотация

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