The study of the current status of the state regulation of medical and pharmaceutical providing of patients with orphan diseases in Ukraine
DOI:
https://doi.org/10.24959/sphhcj.16.25Keywords:
orphan (rare) diseases, government regulation, legal and regulatory frameworkAbstract
The necessary condition for an appropriate level of medical and pharmaceutical providing of patients with orphan diseases (OD) in Ukraine is the presence of the state regulation and the legal and regulatory framework created. It determined the choice of the area of research. As a result of the analysis it has been determined that providing of medical and pharmaceutical care to patients is regulated by 9 main normative legal acts: 2 laws, 2 resolutions, 1 instruction and 4 orders. The main achievements of the regulation of medical and pharmaceutical providing of patients with orphan diseases in Ukraine are the following: confirmation of the order of the lifelong providing of patients with medicines and medical food, approval of the nomenclature of medicines for the centralized providing of 9 nosologies,simplification of the order of the state registration and determination of the procedure of import of the unregistered medicines for OD treatment to the territory of Ukraine. The practical value of the article consists in the analysis and systematization of the current legal and regulatory framework concerning medical and pharmaceutical providing of medicines to patients with OD in Ukraine, determination of the main achievements and directions that require additional legal response from the public authorities.
References
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