Problems of Social Hygiene, Public Health and History of MedicineProblems of Social Hygiene, Public Health and History of Medicine0869-866X2412-2106Joint-Stock Company Chicot115310.32687/0869-866X-2023-31-1-16-19Научная статьяThe rare diseases and orphan medications: Placement in health care of the Russian FederationKomarovI. A.iliya_komarov@mail.ruN. A. Semashko National Research Institute of Public Health15122023311161919022023Copyright © 2023,2023The rare diseases are characterized both by relatively small prevalence in population and complexity of medical care support of patients. In this particular case, the legal regulation of medical care takes its particular placement in health care. The uniqueness of rare diseases requires development of special normative legal acts, definitions and treating approaches. One of such approaches are orphan drugs that also are unique, complicated in development and require special legislative regulation. The article presents corresponding legislative terminology in modern Russian health care, actual listings of rare diseases and orphan drugs. The directions to improve current terminology and normative legal regulation are proposed.public healthhealth carerare diseasesorphan drugslistingmedical carepatientlegislationnormative legal regulationобщественное здоровьездравоохранениередкие заболеванияорфанные лекарственные препаратыпереченьмедицинская помощьпациентзаконодательствонормативно-правовое регулирование1.Taruscio D., Vittozzi L., Stefanov R. National plans and strategies on rare diseases in Europe. Adv. Exper. Med. Biol. 2010;(686):475-91.2.Miller K. L., Lanthier M. Investigating the landscape of US orphan product approvals. Orphan. J. Rare Dis. 2018;183(13):1-8.3.Соколов А. А., Волгина С. Я., Нагибин О. А. Анализ оказания специализированной медицинской помощи пациентам с редкими заболеваниями. Проблемы стандартизации в здравоохранении. 2019;7(8):51-62.4.Соколов А. А., Александрова О. Ю., Комаров И. А. Проблемы оказания высокотехнологичной медицинской помощи пациентам, страдающим редкими заболеваниями. Проблемы стандартизации в здравоохранении. 2019;7(8):63-72.