Ways of improving the legal regulation of human organ and tissue transplantation in the Russian Federation

E. Karakulina, S. Khomyakov, O. Aleksandrova, I. V. Lysikov, S. V. Shedenko, S. Gautier
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Abstract

Over the past 10 years, significant breakthroughs have been achieved in Russian transplantology in the field of regulatory legal framework. During this period, the powers of government authorities in the field of healthcare on organization of transplant care and organ donation have been defined, and sources and mechanisms for target financing of medical activities related to organ donation for transplantation purposes have been identified. The procedure for providing medical care under surgery (human organ and/or tissue transplantation) has been adopted, and a state registry system for donor organs, donors and recipients has been created. Measures on organ donation and transplantation in the Russian Federation have been approved within the «Healthcare Development», a framework of the state program of the Russian Federation. The Shumakov National Medical Research Center of Transplantology and Artificial Organs (Shumakov Center) has also been identified as the core institution that coordinates the activities of the entire transplant industry in the Russian Federation. Transplant medical care is currently being provided by specialist physicians trained in human organ and tissue transplantation, in collaboration with other specialist physicians. The Nomenclature of Specialties of Specialists with Higher Medical and Pharmaceutical Education, approved by the Russian Ministry of Health via Order No. 700n of October 7, 2015, does not contain a separate specialty related to human organ and tissue transplantation activities, and this is quite justified. However, in order to improve the legal regulation of transplantation activities, it is necessary to unify the requirements for specialists providing medical care in human organ/tissue transplantation. This can be achieved by developing uniform approaches to the definition of labor functions in the professional standards of specialist doctors involved in transplantation.
改进俄罗斯联邦人体器官和组织移植法律规制的途径
在过去的10年里,俄罗斯移植学在监管法律框架方面取得了重大突破。在此期间,界定了政府在医疗保健领域组织移植护理和器官捐赠的权力,并确定了与移植目的的器官捐赠有关的医疗活动的目标融资来源和机制。通过了手术(人体器官和/或组织移植)下提供医疗护理的程序,并建立了捐赠器官、捐赠者和接受者的国家登记系统。俄罗斯联邦的器官捐赠和移植措施已在俄罗斯联邦国家方案框架“医疗保健发展”框架内获得批准。舒马科夫国家移植和人造器官医学研究中心(舒马科夫中心)也被确定为协调俄罗斯联邦整个移植行业活动的核心机构。移植医疗目前由受过人体器官和组织移植培训的专科医生与其他专科医生合作提供。俄罗斯卫生部通过2015年10月7日第700n号命令批准的《高等医学和药学教育专家专业名称》不包含与人体器官和组织移植活动相关的单独专业,这是完全合理的。然而,为了完善对移植活动的法律规制,有必要统一对提供人体器官/组织移植医疗服务的专家的要求。这可以通过在参与移植的专科医生的专业标准中制定统一的劳动功能定义方法来实现。
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