Source: http://wl.medlist.org/2019_05_29/
Timestamp: 2019-09-18 07:54:05
Document Index: 584406726

Matched Legal Cases: ['Art. 4', 'art 1', 'Art. 4', 'arts 2', 'Art. 4', 'art 2', 'Art. 11']

Modernization of State Administration System in the Health Care Sphere of Ukraine | Wiadomości Lekarskie
Serhii V. Knysh1, Sergiy M. Gusarov2, Nikolay L. Shelukhin3, Ivan F. Kharaberiush3, Viktoriia R. Bila4
1 Rivne Institute of the Kiev University of Law of the National Academy of Sciences of Ukraine, Rivne, Ukraine
3 Mariupol State University, Mariupol, Ukraine
4 University of the State Fiscal Service of Ukraine, Irpin, Ukraine
Introduction: A new medical reform started in Ukraine from January 1, 2018, new bills were drafted and the current legislation was amended. The legislator began to gradually abandon organizational and legal ways to improve the functioning of medical institutions in order to develop the market of medical services, as well as to ensure the protection of patients’ rights. The main issue of health care reform was the improvement of state administration, in particular the creation of new mechanisms for financing medical institutions.
The aim: The objective of the article is to conduct theoretical study of the specific features of state administration in the health care sphere in Ukraine and to substantiate practical recommendations for its improvement taking into account the European integration processes.
Materials and methods: The author of the article has used the methods of analysis and synthesis, as well as a comparative legal method. The analysis of the current legislation and world experience in reforming the medical sector assisted to determine the problematic issues of this publication, as well as to formulate the author’s point of view on the ways to improve state administration through the health care system under conditions of medical reform in Ukraine.
Review: The author has studied the directions for the modernization of state administration by the health care system in the context of medical reform in Ukraine.
Conclusions: It has been emphasized that the management reform by its nature does not pay enough attention to ensuring the medical rights of citizens, as evidenced by the legislation’s provisions regulating the access to a patient data. Improving public administration of the health care sphere is possible through the involvement of a group of international experts from among the EU Member States to determine the optimal mechanism for transitioning to the system of compulsory state health insurance.
KEY WORDS: state administration, health care institution, health protection system, medical reform, organization model of the health protection system
Wiad Lek 2019, 72, 5 cz. I, 887-891
The relevant issue while implementing medical reform in Ukraine is the improvement of public administration in the health care sphere. Different aspects of this problem were studied in the scientific works of Z.S. Hladun, V. Ye. Kovrihina, B.O. Lohvinenko, O.A. Melnychenko, I.M. Prashycha, V.I. Teremetskyi, V.V. Shevchuk and other scholars. However, the ongoing reform of the health care system in Ukraine requires the introduction of new management methods to increase the level of guaranteeing medical rights of Ukrainian citizens. Problems of legal regulation of medical activity determine the search for ways to improve the system of ensuring and protecting patients’ rights and can not be solved without analyzing the legal status of subjects of management activity in the health care sphere in Ukraine, which determines the relevance of this study. In particular, there is still no adequate scientific substantiation of the effectiveness of the National Health Service, its powers and interaction with other subjects of state administration in the health care sector of Ukraine.
The objective of the article is to study the specific features of state administration in the health care sphere in Ukraine and to substantiate practical recommendations for its improvement taking into account the European integration processes.
The author of the article has used methods of analysis and synthesis, as well as a comparative legal method. The analysis of the current legislation and world experience in the medical sector reform assisted to determine the problematic issues of this publication, as well as to formulate the author’s point of view on the ways to improve state administration through the health care system under conditions of medical reform in Ukraine.
Legal provision of managerial relations in the health care sphere is one of the directions of state authorities’ activity in any country. Therefore, it is important that the medical reform implemented in Ukraine is aimed at improving the institution of public administration in the health care system and modernizing the management tools applied by its subjects.
The majority of scholars in scientific literature understand the executive authorities as the subjects of management activity in the health care sphere. It is explained by the fact that state administration involves the direct administrative influence on the objects of management using administrative and authoritative powers and methods, which are marked by the directive instructions, binding for execution.
Other state authorities (for example, the President of Ukraine, Verkhovna Rada of Ukraine) carry out state regulation, which involves the establishment of certain rules of conduct. At the same time, state regulation of social relations is mainly carried out through the adoption of relevant legislative acts [1, p. 73]. We note that a significant role in the adoption of normative and legal acts belongs to the executive authorities in the health care sphere, namely, the Ministry of Health of Ukraine. Therefore, within the limits of administrative activity, the executive authorities carry out state and legal regulation of their activities, besides the instruments of direct administrative influence on the objects.
This statement has been reflected in the current national health care legislation. For example, the Art. 4 of the Law of Ukraine “On Medical products” is entitled “State Administration in the Field of Creation, Production, Quality Control and Sales of Medical Products” and consists of three parts. Part 1 of the Art. 4 states that Verkhovna Rada of Ukraine defines the state policy and implements the legislative regulation of relations in the field of creation, production, quality control and sale of medical products” [2]. Parts 2 and 3 of the Art. 4 notes that the Cabinet of Ministers of Ukraine and other central executive authorities carry out state administration on the relevant issues.
This indicates to the fact that one of the areas of state administration exercised by the Cabinet of Ministers of Ukraine and other central executive authorities in the health care sphere is the state and legal regulation of the relevant issues [3, p. 65]
The system of public administration of the health care sphere and the need for its reform is revealed in most scientific works through the prism of sources of financing the medical sector.
Considering the classification of management systems by the type of financing, we note that Ukraine in contrast to the EU Member States that successfully implemented the transition from the budget health care system to the system of the state health insurance (Latvia, Lithuania, Estonia, etc.), still does not have the conceptual vision of the system that has to be created instead of the current one.
Today, the main task of the state – is to provide high-quality medical care at all levels and a decent salary to physicians. That is the reason why the Ministry of Health of Ukraine introduces systemic changes in the health care. First of all, we are talking about the reform in financing within the health care system [4].
According to the Concept of Health Care Financing Reform in Ukraine, approved by the Cabinet of Ministers of Ukraine on November 30, 2016, No. 1013-p, a budget model for health care financing was introduced. This model involves financing of the health care for all categories of people from the general tax revenues to the state budget. At the same time, the bulk of medical institutions are state-owned.
However, back in 2005, researchers in the health care sector paid attention to the need to transform existing state and municipal health care institutions, from budget-financed, into non-commercial business entities operating without budget funding. Researchers in the law sphere grounded the necessity of the existence of medical institutions as subjects of entrepreneurial activity, in terms of their creation as the subjects of private law, focusing on contracts for state orders for medical care [5, p. 227].
One of the first steps towards qualitative changes in the health care system was the adoption of the Law of Ukraine dated from April 6, 2017 “On Amendments to Certain Legislative Acts on the Improvement of Legislation Regarding the Activities of Health Care Institutions”, where paragraph 2 of the Final Provisions states that the state and municipal health care institutions – budget institutions can be reorganized into state-owned enterprises or municipal non-profit enterprises. That is, state and municipal health care institutions are granted the right to become autonomous [6]. However, in accordance with clause 2 of the Final and Transitional Provisions of the Law of Ukraine dated from October 19, 2017 “On State Financial Guarantees of Medical Care of the Population”, municipal health care institutions, which have not concluded agreements on medical care with the Authorized Agency, may temporarily, during 2018-2019 period according to the decision of the Cabinet of Ministers of Ukraine, fund the provision of primary health care by subventions from the state budget to the relevant local budgets [7]. That is, the state, having foreseen the right of the state and municipal health care institutions to reorganization and obtaining more autonomy, has created the conditions that encourage these institutions to exercise their right.
In order to fulfill the mediator’s functions between the state and health care institutions the National Health Service of Ukraine (hereinafter – NHSU) was established in 2017. NHSU is the central executive agency that implements state policy in the field of state financial guarantees of medical care of the population. Activities of the NHSU are directed and coordinated by the Cabinet of Ministers of Ukraine through the Minister of Health.
We note that the budget has more than 15 billion hryvnias in 2019 for the needs of primary health care institutions. This money will be distributed by the NHSU in accordance with the concluded agreements. Money will not be provided without an agreement with the NHSU, because a medical subvention for institutions of primary level in this year is not provided [8].
Consequently, the state-owned or municipal medical institutions, unlike private ones, have no freedom to choose whether or not to sign an agreement with the NHSU. The latter receives a financial leverage over the provision or non-provision of funds to a health institution. This makes health care institutions to some extent dependent on the policy of the NHSU and deprives the actual autonomy in managerial affairs.
On the other hand, the activity of the NHSU as a manager of funds that a health care institution may receive, should be subordinated and accountable for minimizing corruption risks.
As we know, ineffective control over the reform of medical care at the first level has led to a number of problems, including an artificial increase in the number of affiliated patients to improve the financial support for physicians, the actual lack of the possibility to treat a fixed number of patients (for example, in an acute epidemic period), an imbalance in the wages of average medical staff and physicians, as well as general practitioners at the primary level and specialized specialists of the second and third level [9].
The Ministry of Health of Ukraine plans in 2019 to introduce new electronic instruments: electronic recipe, patient card and referral [10]. At first glance, this is a significant positive, but after analyzing the ability of citizens living in rural areas to receive an electronic recipe or an elderly person to fill out an electronic form, one can conclude that it is impossible to take advantage of these innovations to the full extent within the specified timeframes. Free courses for improving computer literacy are held in city libraries for the elderly people in some European countries, in particular in Latvia. Of course, the average domestic pensioner will not be able to effectively implement his own medical rights due to the low level of computer skills and the lack of the access to the Internet in certain areas.
The European Union has effectively implemented the “E-Health” system, which provides electronic document circulation in the health care sphere in many vectors and greatly simplifies the overall management of this area. But the introduction of telecommunication technologies requires significant financial costs and the construction of a secure network between medical institutions to ensure the safety of personal data of patients [4].
According to the survey conducted in 2017, it was determined that 82% of surveyed Ukrainians supported the view that domestic medicine was not functioning and needed reform.
Such indicators were based on the fact that not all the population was fully informed about the nature of the reforms, and due to technical problems with electronic registries the process became more complicated. Besides, the new legislation has gaps and conflicts that do not allow the most effective resolution of relations that arise in the health protection sphere [11, p. 156].
Thus, according to Part 2 of the Art. 11 of the Law of Ukraine “On State Financial Guarantees of Medical Care of the Population” dated from October 19, 2017, No. 2168-VIII, the access to patient data contained in the electronic health care system is possible only if there is the consent of a patient (his legal representative) obtained in a written form or in a form that allows to conclude about the obtained consent. The access to information about the patient is possible without the consent: in case there is evidence of a direct threat to the patient’s life, in case that the consent of a patient or his legal representatives can not be obtained (until the time when the consent is possible) or by a court decision [7].
Considering the fact that only one of the listed cases is sufficient to obtain the access to information about a patient without his consent, the direct threat to the patient’s life is not related to the inability to obtain such a consent. That is, even when the patient is conscious, but his life is under the direct threat, his consent to the access to personal data is not required.
Therefore, there is a need to ensure the patient’s right to informed voluntary consent of the latter for medical intervention – consent of the patient or (in clearly defined cases) his legal representative for medical intervention, methods of such intervention, related to it risk and possible alternative treatment methods [12, p. 14]. More thoroughly this issue is highlighted in the scientific work of V.I. Teremetskyi and O.Ye. Avramova [13].
The Council of Europe, a member of which is Ukraine since 1995, issued the “Recommendations of the Committee of Ministers to Member States on managing patients’ safety and preventing adverse events in the health care sphere” dated from May 24, 2006, which emphasized the importance of: 1) policy formulation in the health care sphere, aimed at improving the quality of medical treatment; 2) the development of well-defined limits for patient’s safety, which would contribute to the culture of safety at all levels of health care [14].
In addition, the European Charter of Patients’ Rights (2002) has led to the development of the institution of Ombudsman for the Rights of Patients in European States. Since the ratification of the European Social Charter by Ukraine in 2006, the state has undertaken the duty to ensure the effective execution of the right to health care and the right to social and medical assistance [14].
Taking into account the above, it is believed that the aim of improving the state mechanisms for ensuring and protecting the patients’ rights is to enshrine the patients’ rights with a special Law of Ukraine “On Guarantees of Patients’ Rights” and the establishment of the institution of the Medical Ombudsman – the Ombudsman for Patients’ Rights.
At the same time, according to the survey results of the sociological group “Rating”, 76% of patients who have chosen family doctors in 2018 are satisfied with them, 18% hesitate to assessments, and only 6% expressed dissatisfaction (Fig.1) [15].
At the same time, among the changes that patients received after the reform, they indicated a more responsible attitude of the physician to patients, better conditions for admission (repair, modern equipment), free laboratory tests, etc. [15].
Considering the perspectives for reforming the health care system, it should be noted that in the future – there is the reform of ambulance, the work of specialized and highly specialized medicine and the improvement of state regulation of procurement of medical products [4].
Thus, the reform of the health care system in Ukraine is carried out on theoretical and practical levels. Nowadays, the legislator has made important steps towards modernizing state administration in the health care sphere, but the national vector of reform does not take into account advanced European practices in the medical sector. In particular, it is about introduction of compulsory state health insurance.
The authors of the article have found out that the management reform by its nature does not pay due attention to the provision of medical rights of citizens, as evidenced by the provisions of the legislation regulating the access to patient data.
Improvement of public management in the health care sphere is possible due to the involvement of a group of international experts from among the representatives of the EU Member States in order to determine the optimal mechanism for transition to the system of compulsory state health insurance. The authority and the status of the National Health Service of Ukraine should be reviewed, and the main criterion for assessing the effectiveness of the reform should be not the time for a full transition to the health insurance system, but the level of ensuring medical rights of Ukrainian citizens.
1.	Hladun Z.S. Kontseptualni zasady derzhavno-pravovoho rehuliuvannia vidnosyn u sferi okhorony zdorovia naselennia [Conceptual principles of the state and legal regulation of relations in the health care sphere. Medical law of Ukraine: problems of formation and development]. Medychne pravo Ukrainy: problemy stanovlennia ta rozvytku. Materialy I Vseukrainskoi naukovo-praktychnoi konferentsii 19–20 kvitnia 2007 r., m. Lviv. 2007: 73–79 (In Ukrainian).
2.	Pro likarski zasoby [On Medicinal Products]: zakon Ukrainy vid 04.04.1996 No 123/96-ВР. Available from: https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80 (In Ukrainian).
3.	Hanna Sarybaieva. Derzhavno-pravove rehuliuvannia u sferi okhorony zdorovia: postanovka pytannia [State regulation of the health protection: basics of the problem]. Natsionalnyi iuridicheskii zhurnal: teoriia i praktika. 2018; No 2-1 (30):64–67 (In Ukrainian).
4.	Serhii Knysh. Udoskonalennia publichnoho upravlinnia sferoiu okhorony zdorovia v Ukraini: analiz reformy ta yevroperspektyvy [Improving public health management in Ukraine: analysis of reforms and European perspectives]. Aktualni problemy pravoznavstva. 2019; No 1 (In Ukrainian).
5.	Kovryhina V. Ye. Administratyvno-pravove rehuliuvannia ekstrenoi medychnoi dopomohy [Administrative and legal regulation of the emergency medical treatment]. D.Sc (Ph.D.) dissertation. Kyiv. 2017: 227 (In Ukrainian).
6.	Pro vnesennia zmin do deiakykh zakonodavchykh aktiv shchodo udoskonalennia zakonodavstva z pytan diialnosti zakladiv okhorony zdorovia [On amending some legislative acts for improving the legislation on the activit of health care institutions]: zakon Ukrainy vid 06.04.2017 № 2002-VIII. Available from: https://zakon.rada.gov.ua/laws/show/2002-19 (In Ukrainian).
7.	Pro derzhavni finansovi harantii medychnoho obsluhovuvannia naselennia [On State Financial Guarantees of Public Health Care]: zakon Ukrainy vid 19.10.2017 No 2168-VIII. Available from: https://zakon.rada.gov.ua/laws/show/2168-19 (In Ukrainian).
8.	Korpusenko B. Pershyi etap medychnoi reformy zavershuietsia. Hroshi ydut za patsiientamy v statsionary. UNIAN. Available from: https://hromadske.ua/posts/pershij-etap-medichnoyi-reformi-zavershuyetsya (In Ukrainian).
9.	Medychna reforma vzhe maie rezultaty, a protiahom 3-5 rokiv ukraintsi vidchuiut novu yakist medychnykh posluh, – Volodymyr Hroisman. Available from: https://www.kmu.gov.ua/ua/news/medichna-reforma-vzhe-maye-rezultati-protyagom-3-5-rokiv-ukrayinci-vidchuyut-novu-yakist-medichnih-poslug-volodimir-grojsman (In Ukrainian).
10.	«Skoro my zabudemo pro rozmezhuvannia na derzhavni i pryvatni likarni»: interviu z Pavlom Kovtoniukom. Available from: https://ukr.segodnya.ua/ukraine/-skoro-my-zabudem-o-razgranichenii-na-gosudarstvennye-i-chastnye-uchrezhdeniya-intervyu-s-zamestitelem-ministra-zdravoohraneniya-pavlom-kovtonyukom-ch1-1205395.html (In Ukrainian).
11.	Teremetskii V.I., Muzychuk A.N., Salmanova E.Iu., Kaznacheeva D.V., Knysh S.V. Ukreplenie dogovornykh nachal v pravootnosheniiakh mezhdu patsientom i lechebnym zavedeniem pri reformirovanii sistemy zdravookhraneniia v Ukraine [Strengthening of contractual principles within legal relations between a patient and a medical institution while reforming the health care system in Ukraine]. Georgian Medical News. 2018; No 11 (284): 155–159 (In Georgian).
12.	Parashchych I.M. Derzhavni mekhanizmy zabezpechennia ta zakhystu prav patsiientiv v Ukraini: stan i tendentsii rozvytku [State mechanisms of ensuring and protecting the rights of patients in Ukraine: state and tendencies for the development]. D.Sc (Ph.D.) dissertation author’s abstract. Kyiv. 2009: 23 (In Ukrainian).
13.	Vladyslav T., Avramova O. Informed voluntary consent for medical intervention. Advanced research biobank and pathophysiology. 2018; No 1 (February): 72–78.
14.	Diialnist ombudsmena z prav patsiientiv yak zasib rehuliuiuchoho vplyvu derzhavy. Available from: https://www.apteka.ua/article/339724 (In Ukrainian).
15.	Medychna reforma: yak zminylasia sfera okhorony zdorovia za rik. Available from: https://24tv.ua/health/medichna_reforma_v_ukrayini_2018_plyusi_i_minusi_novoyi_medreformi_v_ukrayini_n1081833 (In Ukrainian).
Serhii V. Knysh
Rivne Institute of the Kiev University of Law
5, Korolenko str., Rivne, 33028, Ukraine
tel: +380503784730
e-mail: s.knush@ukr.net
Received: 08.03.2019
Fig 1. Assessment of Family Doctors’ Activities in Ukraine.