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Legal Regulation Of Nuclear Medicine Centers: Current Status And Development Objectives
 
PIIS231243500022185-1-1
DOI10.18572/2410-4390-2018-4-60-64
Publication type Article
Status Published
Authors
Viktoria V. Romanova 
Occupation: Head of the Department of Energy Law
Affiliation: Kutafin Moscow State Law University (MSAL)
Address: Russian Federation, Moscow
Journal nameEnergy law forum
EditionIssue 4
Pages60-64
Abstract

In 2015, Resolution of the Government of the Russian Federation No. 2144-p dated October 23, 2015, approved the “road map”: Development of Nuclear Medicine Centers. The nuclear medicine centers are currently designed and built in many cities of the Russian Federation. At the same time, experts draw attention to the gaps in the legal regulation of relations concerning construction of nuclear medicine facilities, application to nuclear medicine centers of regulations on design, construction, and commissioning of nuclear power plants, the low level of competence of contractors that win tenders on the basis of formal evidence of compliance with the requirements of procurement laws, and insufficient classification of radiopharmaceuticals. There are few legal researches on the problems of legal regulation of nuclear medicine. Therefore, it seems to be relevant to perform legal research on the current state of legal support for nuclear medicine, design, construction, and operation of the nuclear medicine centers providing diagnostic services and treating individuals. It is necessary to decide what is legal meant by the nuclear medicine center, what social relations arise in the process of creation and functioning of the nuclear medicine centers, to study sources of legal support of the nuclear medicine centers, and to determine the objects of their further development. The article proposes classifications of the nuclear medicine centers, inter alia, on the following grounds: (1) by the organizational and legal form of incorporation: the business subdivision of a medical institution and the independent medical institution; (2) by functional purpose — diagnostic centers; diagnostic and treatment centers; centers where diagnostics is performed, radiopharmaceuticals are made, and patients are treated; (3) as the object of design and construction: the department in an existing medical institution and the separate object of design and capital construction. Proper legal support is necessary for all parties to the social relations: for enterprises producing isotope products, manufacturing diagnostic equipment, and producing medical preparations, for design and contracting organizations involved in the design and construction of the nuclear medicine centers, for health care professionals; for individuals who need to undergo diagnostics and treatment, for government agencies and organizations that regulate and control activities. The article presents proposals for possible unification of regulations governing creation and functioning of the nuclear medicine centers.

Keywordsenergy law, nuclear law, legal use of radioactive isotopes in medicine, legal framework of the nuclear medicine centers
Received03.11.2018
Publication date21.12.2018
Number of characters14130
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1 8.8 million people die of cancer every year. 70 percent of these deaths occur in developing countries. In some African countries, less than 15 percent of oncological patients survive for five years after cervical and breast cancer is diagnosed. In many industrially advanced countries of the world, these diseases are often cured.
2 Experts note that to reduce cancer mortality, it is necessary to detect such diseases at the early stages and to more actively implement modern methods of treatment. [1]
3 Applications of nuclear medicine include not only oncology, but also cardiology, hepatology, urology and nephrology, pulmonology, endocrinology, hematology, allergology, pediatrics, immunology, traumatology, neurology, and neurosurgery. [2]
4 In 1954, the Society of Nuclear Medicine was established in the state of Washington. In 2012, the society changed its name to the Society of Nuclear Medicine and Molecular Imaging. In 1971, the US Chamber of Nuclear Medicine, which sets educational standards and assesses the competence of physicians in the field of nuclear medicine, was created. The Chamber has the right to officially certify specialists in the field of nuclear medicine. In 1985, the European Association of Nuclear Medicine was founded. In 1996, the Interregional Public Organization of Nuclear Medicine Society of Nuclear Medicine was established in Russia. [3]
5 There are few legal research studies on the problems of legal regulation of nuclear medicine. Various aspects of the legal regulation of nuclear medicine were studied in the works of A.I. Ioyrysh, G.B. Romanovsky, and V.V. Romanova. The work of A.I. Ioyrysh examines the definition of the concept of radioactive isotopes for medical use, civil and criminal liability for violation of the requirements for the use of these substances for diagnostic and therapeutic purposes. [4]
6 The work of G.B. Romanovsky studies the concept of nuclear medicine, the legal basis, on which relations are regulated in diagnostics and the use of radiopharmaceuticals. The expanded concept of nuclear medicine is understood by G.B. Romanovsky to include five components: radioisotope diagnostic methods, radionuclide and radiation therapy, technologies for production of radiopharmaceuticals, use of charged particle accelerators for production of isotopes and radiation therapy, computer technologies for obtaining and storing images in tomography, for planning radiation therapy and other calculations. [5] The paper by V.V. Romanova discusses peculiarities of the legal framework of radioactive isotopes and radioisotope products used for nuclear medicine. [6]
7 Medical and technological aspects relating to creation of PET centers were studied in the work of Medradi+Preparat Group. [7]
8 In 2015, Resolution of the Government of the Russian Federation No. 2144-p dated October 23, 2015, approved the “road map”: Development of Nuclear Medicine Centers. [8] The “roadmap” provides for implementation of the following activities: organization and monitoring of existing nuclear medicine centers as well as those under construction and nuclear medicine facilities planned to be built in the Russian Federation taking into account the needs of the population, making a list of infrastructure facilities; preparation of proposals concerning measures to support the nuclear medicine projects; development and approval of standards of medical care for oncological diseases, introduction of changes in the range of medical services as related to inclusion of medical services related to the use of technologies proton beam therapy; development of guidelines for modern good practice for production of radiopharmaceuticals in medical institutions”; development and approval of the federal state educational standard of higher education “Radiopharmaceuticals”.
9 Nuclear medicine is one of the activities of the State Atomic Energy Corporation Rosatom. [9] Leading equipment manufacturers, producers of radionuclides, manufacturers of low-capacity reactors for production of radionuclides, and producers of radiopharmaceuticals are involved in implementation of this line of activity. The official website of Rosatom State Corporation also provides information on creation of a pilot project for an integrated medical facility — PET Center of Rosatom State Corporation for provision of services to the public as well as onestablishment of a nuclear medicine center at the Far Eastern Federal University.
10 According to publicly available data, the nuclear medicine centers are currently designed and built throughout the Russian Federation, including Novosibirsk, Grozny, Khabarovsk, Cheboksary, etc. [10]
11 Modern research of the experts draws attention not only to insufficiency of nuclear medicine centers and high cost of radionuclide studies, but also to insufficiency of the regulatory framework, inconsistency of the existing one, gaps in the legal regulation of relations concerning construction of the nuclear medicine facilities, application to the nuclear medicine centers of regulations on design, construction, and commissioning of the nuclear power plants, low level of competence of contractors that win tenders on the basis of formal evidence of compliance with the requirements of procurement laws, and inadequate classification of radiopharmaceuticals. [11]

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11. Kumar A., Kireev V.S. Review of the Russian Market of Nuclear Medicine // Fundamental Research. 2018. № 2. P. 134–138.

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