Human Blood Legal Regime

Donated blood and its components are widely used in medicine both directly for treatment of patients and as a source for production of medicines. Umbilical cord blood is a rich and easily accessible source of stem cells. Due to its strategic importance in maintaining public health and, at the same time, preserving the potential risk of spreading infectious diseases, this area of medicine is under strict control of the state. The legal regime of blood and its components at the moment is insufficiently defined and does not fully correspond to the current practice of application both in matters of clinical application and production aspects, as well as in the development of medical technologies and new methods of treatment. Existing regulation in the Russian Federation is essentially outdated and highly fragmented, not allowing to maintain the level of medical care at the level of the EU and the USA. The study objective was to determine the legal regime of blood and its components in the Russian Federation, the EU and the USA in view of its applicability to routine medical practice. This objective is accomplished through the following tasks: - To analyze the current state of legal regulation of circulation of blood and its components for clinical use in the Russian Federation, EAEC, EU and USA; - To determine the features of the legal regime of blood plasma as a source for the production of blood products; - To consider the specific features of the legal regime of cord blood as a source of hematopoietic cells; - To identify the main problems and to propose solutions to existing deficiencies of the legislation of the Russian Federation in the areas under consideration. To achieve the objectives of the study and address the objectives, this study was based on the general dialectical method of scientific knowledge, which assumes objectivity and comprehensiveness of knowledge of the phenomena under study. Alongwith it the author was guided in his research by such special scientific methods of research, as logical-legal, historical-legal, method of legal modeling and others. The work considers the legal regime of clinical application of blood components. It was revealed insufficient regulation of the rules of donor blood components application which appeared as a result of cancellation of orders of Russian Ministry of Health regulating this issue and absence of timely developed National or Clinical guidelines which could contain all the information of the cancelled documents. An analysis of the regulation of the circulation of plasma for fractionation was performed. As the main obstacle in providing the Russian market of medicines sufficient number of blood products considered contradiction between the state system of plasma procurement and private ownership of the largest pharmaceutical manufacturers capable to produce a significantly larger number of medicines, than the existing network of medical blood centers. Mechanisms for eliminating the current contradiction are proposed. Fragmentary legal regulation of circulation of both erythrocytes and hematopoietic cells of umbilical cord blood does not allow to take any significant steps for their introduction into clinical practice. Steps to legalize the circulation of umbilical cord blood components are proposed, several approaches to address this issue are considered. The results of the work can be used to build a holistic and consistent system of legal regulation of the circulation of donor and cord blood components both for clinical use and for the production of blood products.