Research Institute of Legal Expertise and Comprehensive Research

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

1. Alekseev S. S. Sobranie sochineniy: v 10 t. T. 2: Spetsialnye voprosy pravovedeniya. — M.: Statut, 2010. — 471 s.

2. Alekseev S. S. Struktura sovetskogo prava. — M., 1975. — 263 s.

3. Barzilova I. S. Ponyatie i yuridicheskaya priroda pravovykh rezhimov // Lex russica. — 2013. — № 11. — S. 1169–1175.

4. Grazhdanskoe pravo / pod red. Yu. K. Tolstogo, A. P. Sergeeva. — SPb.: Teis, 1996. — 552 s.

5. Ershova I. V., Petrakov A. Yu. Rezhim povyshennoy gotovnosti v sisteme pravovykh rezhimov osushchestvleniya predprinimatelskoy deyatelnosti // Lex russica. — 2020. — № 9. — S. 9–20.

6. Zashchita isklyuchitelnykh prav na izobreteniya, ispolzuemye v lekarstvennykh preparatakh: problemy pravovogo regulirovaniya i napravleniya sovershenstvovaniya zakonodatelstva: monografiya / A. A. Ayurova, O. V. Gutnikov, S. A. Sinitsyn [i dr.]; otv. red. O. V. Gutnikov, S. A. Sinitsyn. — M.: IZiSP, Kontrakt, 2019. — 208 s.

7. Intellektualnaya sobstvennost v sovremennom mire: monografiya / pod red. I. A. Bliznetsa. — M.: Prospekt, 2023. — 672 s.

8. Maydykov A. F., Melekhin A. V. Problemy formirovaniya zakonodatelstva ob osobykh pravovykh rezhimakh v Rossiyskoy Federatsii // Zhurnal rossiyskogo prava. — 2005. — № 10. — S. 95–107.

9. Malko A. V., Limanskaya A. P. Spetsialnyy pravovoy rezhim kak osoboe sredstvo pravovogo regulirovaniya // Vestnik Saratovskoy yuridicheskoy akademii. — 2013. — № 6. — S. 120–124.

10. Matuzov N. I., Malko A. V. Pravovye rezhimy: voprosy teorii i praktiki // Pravovedenie. — 1996. — № 1. — S. 16–29.

11. Mokhov A. A. Pravovye rezhimy osushchestvleniya ekonomicheskoy deyatelnosti i samoregulirovanie predprinimatelskoy ili professionalnoy deyatelnosti // Zakony Rossii: opyt, analiz, praktika. — 2015. — № 4. — S. 9–14.

12. Mokhov A. A. Printsipy pravovogo regulirovaniya gosudarstvennoy modeli natsionalnogo zdravookhraneniya // Aktual’nye problemy rossijskogo prava. — 2021. — T. 16. — № 3. — S. 85–96.

13. Predprinimatelskoe pravo / otv. red. I. V. Ershova, G. D. Otnyukova. — M.: Prospekt, 2014. — 621 s.

14. Savenko N. E. Pravovye rezhimy predprinimatelskoy i inoy ekonomicheskoy deyatelnosti: problemy klassifikatsii // Vestnik YuUrGU. Seriya «Pravo». — 2023. — T. 23. — № 4. — S. 71–75.

15. Sidorenko A. I. Sudebnye doktriny v sfere intellektualnykh prav v Rossii i za rubezhom // Zhurnal zarubezhnogo zakonodatelstva i sravnitelnogo pravovedeniya. — 2021. — № 3. — S. 100–115.

16. Sinitsyn S. A. Sravnitelnoe patentnoe pravo: aktualnye problemy / Institut zakonodatelstva i sravnitelnogo pravovedeniya pri Pravitelstve RF. — M.: Infotropik Media, 2022. — 416 s.

17. Tarasenko O. A. Formirovanie doktriny i zakonodatelstva o pravovykh rezhimakh bankovskoy deyatelnosti // Vestnik Permskogo universiteta. Yuridicheskie nauki. — 2021. — Vyp. 51. — S. 105–132.

18. Trakhtengerts L. A. Izobretatelskoe pravo sotsialisticheskikh stran i pravo na otkrytie. — M., 1968. — 148 s.

19. Tsivilisticheskaya kontseptsiya intellektualnoy sobstvennosti v sisteme rossiyskogo prava: monografiya / pod obshch. red. M. A. Rozhkovoy. — M.: Statut, 2018. — 269 s.

20. Tsitovich P. P. Ocherk osnovnykh ponyatiy torgovogo prava. — Kiev: Tipografiya I. N. Kushnereva i K°, 1886. — 248 s.