Medical-social analysis of the normatively-legal basis of Ukrainian and some international documents about palliative and hospice care providing

Baskground. One of the priority directions of scientific research in the field of social medicine and health care is the development and substantiation of the best models for the organization of an affordable, high-quality and efficient PHC System in Ukraine, that requires the formation of a state policy of the PHC support and its implementation with taking into account the best international and national experience, opportunities and conditions of the country. The urgency of the problem and the global need for PHC are growing in connection with the unbridled aging of the population and the spread of severe chronic progressive diseases, including those, a treatment of which is ineffective or hopeless. Purpose: to carry through a medical and social analysis of the current legal framework (CLF) of Ukrainian and some international documents regulating the PHC providing organization, that are the basis for the creation and development of affordable, high-quality and efficient PHC System to the population in Ukraine. Materials and methods. In our analysis Ukrainian and international normative and legal documents, scientific literature were used. The following research methods were applied: system-analytical, comparative content analysis, system approach, generalization and grouping. Results. The legal regulation of the provision of PHC to the population of Ukraine at the state level is carried out by the relevant Laws of Ukraine, decrees of the President of Ukraine, resolutions of the Cabinet of Ministers of Ukraine, orders of the Ministry of Health (MOH) of Ukraine and the Ministry of Social Policy of Ukraine. In particular, the Law of Ukraine "On the Basis of the Legislation of Ukraine on Health Care" dated 19.11.1992, No. 2801-XII, for the first time at the legislative level in 2011, palliative care was recognized as a form of medical care, as well as the definition of the term "palliative care" was defined. Provision of PHC to cancer patients and TB patients was foreseen in the relevant Laws of Ukraine, which are not valid today. Currently, only the "National Targeted Social Program for HIV/AIDS Response for 2014-2018" is in force, which was approved by the Law of Ukraine dated 20.10.2014 No.1708-VII, which defined certain tasks related to the organization and access to PHC to people who live with HIV, training the appropriate staff to provide such care. Unfortunately, the tasks defined by these laws were not implemented: the PHC standards to patients in the facilities of palliative and hospice medicine (PCM) of the MOH of Ukraine have not yet been approved, the system of training has not been implemented, etc. Also today, PHC in Ukraine are regulated by a number of departmental regulatory acts, in particular, by Order of the MOH of Ukraine of 21.01.2013 1 41 "On the organization of palliative care in Ukraine", but there is now a significant need to complete and improve this order, taking into account Ukrainian and international development PHC experience, the results of reforming the Health Care System in Ukraine, new WHO documents, Council of Europe, EAPC, 2ÀÍÐÑ. It is important that valid clinical protocols from different nosologies are complemented by sections "PHC" or "Palliative Medical Care and Care at the End of Life", which has both practical and legal significance. Of particular importance is the Order of the Ministry of Social Policy of Ukraine dated January 29, 2016, No. 58 "On Approval of the State Standard of Palliative Care", which regulates the activities of social protection institutions for the provision of PHC to patients in outpatient settings and at home, and other orders. Conclusions. 1. The content-analysis of the current Laws of Ukraine and some documents of WHO, the Council of Europe, ÅÀÐÑ, 2ÀÍÐÑ and other authoritative international institutes on the PHC organization allowed us to identify positive trends, in particular, the legislative approval of palliative care in Ukraine as a type of medical care, but only in relation to incurable patients with limited predictive life expectancy, and this fact goes in to a discrepancy with modern international documents. 2. The main shortcomings of the acts regulating the PHC organization delivery in Ukraine are the lack of systematic and coordinated regulatory norms, the uncertainty of the criteria of PPs with different nosologies, the lack of mechanisms for determining the status of PPs, the problems of the organization of the PHC providing for incurable sick in both in-patient and out-patient conditions and at home. 3. The aforecited statements require the urgent development and approval of the Order "About the Procedure for the


Introduction
From the second half of the 20th century, the world community began to pay particular attention to questions of the value of human life, providing and protection of fundamental human rights and dignity.In the majority of countries of the world this period is characterized by development of an innovative multidisciplinary and multisectoral approach -Palliative and Hospice Care (PHC) that is designed to ensure that the rights, dignity and needs of one of the most vulnerable populationspalliative patients and their family members -are protected.
The medical and social relevance of PHC is due to the society's need to create and develop an affordable, high-quality and efficient a Palliative and Hospice Care System to the population.The PHC includes: a medical component -palliative treatment of the incurable patient, provision of effective medicines, including ade quate analgesics; a psychological component -psychological support and psychotherapeutic treatment of patients and their families members; a social component -material, legal, technical, etc. assistance to patient's family and/or persons that care palliative patients (PPs); and a spiritual component -the religious, moral and ethical support of PP and their families.According to WHO and the International Association for Hospice and Palliative Care (IAHPC), more than 40 million people in the world require PHC every year, 20 million of which are at the end of their lives (in the terminal stage of a disease).Among PP with severe chronic progressive diseases, almost 39% are patients with cardiovascular disease, 34% -with malignant neoplasms (MN), more than 10% -with chronic respiratory diseases, about 5% are infected with HIV/ AIDS and/or have diabetes, etc. Patients with many other severe chronic progressive diseases that are in the terminal stage of the disease, in particular with dementia, multiple sclerosis, Parkinson's disease, renal and hepatic insufficiency, some neurological diseases, congenital malformations, multidrug-resistant tuberculosis and some others also requires PHC.The experience of many countries of the world convincingly suggests that PHC could the most adequately provide the needs and proper quality of PP life and their relatives, the realiza-tion of their health rights and the preservation of human dignity, especially at the end of life [1][2][3][4][5][6].
The urgency of the problem and the global need for PHC are growing in connection with the unbridled aging of the population and the spread of severe chronic progressive diseases, including those, a treatment of which is ineffective or hopeless.One of the priority directions of scientific research in the field of social medicine and health care is the development and substantiation of the best models for the organization of an affordable, highquality and efficient PHC System in Ukraine, that requires the formation of a state policy of the PHC support and its implementation with taking into account the best international and national experience, opportunities and conditions of the country.
Purpose: to carry through a medical and social analysis of the current legal framework (CLF) of Ukrainian and some international documents regulating the PHC providing organization, that are the basis for the creation and development of affordable, high-quality and efficient PHC System to the population in Ukraine.

Materials and methods
In our analysis Ukrainian and international normative and legal documents, scientific literature were used.The following research methods were applied: systemanalytical, comparative content analysis, system approach, generalization and grouping.

Results and discussion
The analysis of Ukrainian scientific literature allows us to name a number of publications related to the normative and legal provision of PHC in Ukraine, that are works by I. Senyuta (2015) [7], A. Rokhansky (2014) [8], a provision of pharmacotherapy and adequate analgesia, including the use of narcotic and psychotropic drugs in PP treatment were studied by Yu.Gubsky and M. Khobzey Providing of Palliative Medical Care to the Population in Ukraine and the List of Medical Indications for Its Delivery" by the MOH of Ukraine, in which mechanisms and coordination of the various levels of medical care providing, standards of palliative care and maintenance of various category of PPs, criteria for the status of PPs definition, etc should be determined.4. In order to optimize Ukrainian legislation in its part of the PHC providing organization to the population of Ukraine, there is an urgent need for the elaboration and adoption of a Law of Ukraine "About Palliative Care" by Ukrainian Parliament, in which the priorities of state policy, adequate financing of PHC from the State and Regional Budgets and extrabudgetary sources, clearly outline the system of such type of care, determine the state regulation of the provision of PHC, provide a systemicity, continuity and structuring of Ukrainian PHC, help to eliminate inter-departmental barriers on personnel policy issues, provide motivation for specialists in PHC training, PPs and their families with adequate drugs, care facilities, social, psychological and spiritual support etc. 5.An extremely urgent task that will ensure the development of an accessible, high-quality and efficient PHC System is the development and approval of the "State Social Program for the Development of Palliative and Hospice Care in Ukraine" by the Cabinet of Ministers of Ukraine and Parliament of Ukraine.This document will help to realize a right of palliative patients and their families members for appropriate quality of life and its worthful ending.For the first time at the legislative level, Palliative Care was recognized as a type of medical care, along with emergency, primary, secondary (specialized), tertiary (highly specialized) and medical rehabilitation, which we hope will contribute to the formation and development of an affordable, high-quality and efficient PHC System for the population of Ukraine.

Keywords
The Article 35-4 "Palliative Care" of this Law states: "At the latest stages of incurable disease, patients receive palliative care, that includes a set of measures aimed at alleviating the patient's physical and emotional suffering, as well as providing psychosocial and moral support to their family members.
Palliative care is provided for free…".But in connection with the adoption of a number of regulatory health care reform acts, that are currently being implemented at the primary level of a medical care provision (PMCP), the following concepts need to be clearly defined in laws and other normative-legal documents: - For today, PHC is regulated by a number of departmental regulatory acts in Ukraine.In particular, the "Procedure for the Provision of Palliative Care" (including the task and organization of the PHC provision) and "List of medical indications for the provision of palliative care", the main medical and legal definitions of PHC (palliative care, palliative care levels, palliative patient, etc.), a procedure for the provision of palliative care (including the task and organization of the provision of PHC), etc. by the Order of the MOH of Ukraine dated 21.01.2013,№ 41, "About the Organization of Palliative Care in Ukraine" are implemented.In this document are the following PHC definition: "Palliative care is a kind of medical care that helps to improve the quality of a palliative patient's life and helps family members by preventing and relieving the suffering of an incurably sick person; general palliative care -palliative care, that is provided to the palliative patient from the moment of diagnosis of incurable progressive disease by medical personnel; specialized palliative care -palliative care, provided to a Patient with complex needs that cannot be adequately cured at the primary level of medical care ...".
These definitions are important to consider when designing an organizational and functional PHC model at different levels of health care.It is also important for practitioners to have criteria for determining the status of a PP and indications for the PHC provision.It should be noted that in different countries the criteria for determining the status of PPs are different, depending on the financial capacity of the population health and social protection services.In the rich countries, there are no criteria for "incurable diseases" and "limited life expectancy".As already mentioned above, in the order of the NOH of Ukraine dated 21.01.2013,No. 41, "About the Organization of Palliative Care in Ukraine", it is defined: "A palliative patient is a patient of any age groups whose illness is not curable; ... The status of the Patient is determined by the treating physician since the diagnosis of an incurable progressive disease with a predicted life expectancy." So, adult palliative patients -individuals require the PHC.This group includes: patients with incurable stages of malignant neoplasms (MN) of the IV clinical group; patients with advanced chronic noncurable diseases in the terminal stage, for ex. with severe heart, lung and kidney failure, cerebrovascular diseases (significant functional impairment after a stroke), neuro-degenerative disorders and dementia, etc; patients with incurable infectious diseases, for ex.those with HIV/AIDS, TB/ HIV co-infection, those in the terminal stages of hepatitis B and C, with MDR TB, etc.
For today, there is a significant need to supplement and improve this Order, taking into account the Ukrainian and international PHC development experience, the results of the reform of the Health Care System in Ukraine, new WHO documents, document of the Council of Europe, ЕАРС, ІАНРС [4 -6].For over a year a working group that includes members of the Shupyk NMAPE the Institute of Family Medicine the Palliative and Hospice Medicine Department, experts from NGO "Ukrainian League of Palliative and Hospice Care" and the International Public Organization "The International Association for "Health of Society" and other NGOs, suggested proposals the Order of the MOH of Ukraine, but, unfortunately, the official approval of this urgent document still does not exist.
It is important to have valid clinical protocols of different nosologies complemented by sections "PHC" or "Medical Care at the End of Life".After all, practitioners need to have clear criteria, signs and symptoms when it is possible or necessary to stop a hopeless etiopathogenetic treatment and to focus on symptomatic palliative care.For now, only "Unified Clinical Protocol of Primary, Secondary (Specialized), Tertiary (Highly Specialized) and Palliative Care "Dementia" (approved by the order of the MOH of Ukraine dated July 19, 2016, No. 736) contains a separate section 3.4."Palliative Health Care".
Taking in a count a current situation in Ukraine, one from the last orders of the MOH of Ukraine dated March 19, 2018, No. 504 "About Approval of the Procedure for the Provision of Primary Health Care" (registered with the Ministry of Justice of Ukraine dated March 21, 2018, No. 348/31800), should be showed.In this document we can see a "List of Medical Services to Provide a Primary Health Care", for p. 12: "Providing specific palliative care services to patients of all ages that includes regular assessment of the seriously ill patient and his/her needs; assessment of level of pain and pain treatment; the appointment of narcotic drugs and psychotropic substances in accordance with the law; treatment for such symptoms as constipation, nausea, strangulation, etc.; counseling and training of persons caring a patient; coordination of medical, psychological, etc. needs of the patient"; and p. 13. "To refer patients according to medical indications to provide them with palliative care to specialized unions".
It should be noted that in the draft Law of Ukraine "About Primary Medical Care on the Basis of Family Medicine", registration # 6634 dated 22/06/2017, which was completed by the staff of the Shupyk NMAPE the Institute of Family Medicine, and in particular the Pal-Соціальна медицина / Социальная медицина / Social medicine liative and Hospice Medicine Department, in the Article 26 we can see a part about "Providing elements of palliative care and the procedure of interaction of primary health care providers with secondary (specialized), tertiary (highly specialized) medical care and palliative care": "1.Palliative care is provided to the patient by specialists of family medicine in outpatient settings or at the patient living place.
2. Family medicine specialists are obliged to provide palliative care items in accordance with medical certificates on the basis of medical standards (clinical protocols) approved by the special state organ, that ensures the formation and implementation of state policy in the field of healthcare".
We hope that if this Law is adopted by the Parliament of Ukraine, the MOH of Ukraine will be forced to develop an improved order "About the Procedure for Provision of Palliative Care to the Population in Ukraine and a List of Medical Indications for Its Provision" in accordance with the reforming the Health Care System conditions.Today, it is extremely necessary to legislate, at the state and local levels, to involve, coordinate and co-operate with representatives of various institutions, structures, ministries and departments on the provision of PHC to the population.In our opinion, the Order of the Ministry of Social Policy of Ukraine dated January 29, 2016, No. 58 "About Approval of the State Standard of Palliative Care" (registered with the Ministry of Justice of Ukraine on February 17, 2016, No. 247/28377), that regulates the activities of the institutions, is extremely important.It regulates social protection of the population in the issues of providing PHC to patients in outpatient settings and at home.In this Order in p. 1.4 the definitions of "palliative/hospice care", "recipient of social care services for palliative care", "multidisciplinary team", etc. are given.
It should be noted that the Ministry of Social Policy of Ukraine forms some acts about Palliative Care more active, than MOH of Ukraine.For ex., the Order of the Ministry of Social Policy of Ukraine from 09.08.2017, # 1293, "About Approval of Provisions of Palliative Care for Elderly, Persons with Disabilities and Children with Disabilities" (Registered by the Ministry of Justice of Ukraine from 09.04.2017 # 1078/30946).The Paragraph 1 of this Order defines the "Palliative Care Department for the elderly, people with disabilities and children with disabilities".It is important that a Section II."Tasks and Main Directions of the Department's Activity" defines the complex multidisciplinary tasks of the Department that are in line with international standards.And a Section VI "Medical Care in the Department" regulates the procedure for provision of palliative care.
The abovementioned should be taken in to a count by MOH of Ukraine in the development of next orders.
Accessibility, quality and efficiency of the PHC is achieved by ensuring coordination and cooperation between health care and social protection institutions and personnel.These To summarize, we have determine the main vectors in PHC providing and development: to pass a Law of Ukraine "About the Palliative Care" (discussed at the Round Table in the Parliament of Ukraine on 26.06.2016), that should determine the priorities of the state policy about PHC, ensure adequate financing of PHC from the State and Regional Budgets and extrabudgetary sources, clearly outline the system of such type of care, determine the state regulation of the provision of PHC, provide a systemicity, continuity and structuring of Ukrainian PHC, help to eliminate interdepartmental barriers on personnel policy issues, provide motivation for specialists in PHC training, PPs and their families with adequate drugs, care facilities, social, psychological and spiritual support etc; development and approval of the Order of the MOH of Ukraine "About the Procedure for the Provision of Palliative Care to the Population in Ukraine and the List of Medical Indications for Its Delivery", that will define and provide mechanisms and coordination of different levels of medical care provision, standards of palliative care and maintenance of various categories of PPs, and the procedure for granting the status of the PP, characteristics of the PPs in the childhood and at the end of life, etc.; development and approval of clinical protocols, guidelines and recommendations by the MOH of Ukraine for the main chronic progressive incurable diseases that lead to a great part of mortality, such as ma-Соціальна медицина / Социальная медицина / Social medicine lignant neoplasms, diseases of the cardiovascular, respiratory, endocrine systems, musculoskeletal system, chronic renal and liver failure, Parkinson's disease, Alzheimer's disease, HIV/AIDS, TB, hepatitis B and C, etc., whose treatment requires not only anesthetics, but adequate pharmacotherapy, medical and psychological rehabilitation, palliative radiotherapy and chemotherapy, surgical treatments, diet and nutritional support, professional care, etc. approval of the MOH Ukraine a State List of Drugs, according to WHO recommendations, providing PPs with prolonged painkiller-effect and children's forms and dosage of opioid analgesics and psychotropic drugs.An approve of modern forms of adequate drugs, including transdermal systems, methods of calculating real needs drugs, including analgesics, etc.
development and approval of modern methods of calculating the actual need for PHC for different categories of patients and forms of a single registry of PPs by the MOH of Ukraine.
Thus, according Ukrainian Law the main goal of palliative care is to ensure proper quality of life in its final phase (end-stage disease), to ease physical and mental suffering incurable patients and their families for a maximum and to preservation of human dignity of PPs.WHO, Council of Europe, EAPC, ІАНРС and other authoritative international organizations appeal that each country should set up appropriate PHC services to meet the PP's medical and social needs.The main areas in providing PHC should not only reduce the suffering of PPs, but also adequate psychological help, social support, spiritual, moral and ethical support, communication with relatives, allowing family members to prepare themselves for the end of PPs biological life.Unfortunately, the insufficient attention is not paid to issues such as communication with relatives of PPs, the prevention of "emotional burnout syndrome" of medical and social workers, family members who provide PHC to incurable patients in health care institutions.
Considering the PHC modern world paradigm, the search for optimal organizational and functional models for providing PHC, ensuring its quality and availability for the population are becoming especially relevant.Today, the Ukrainian PHC has achieved the first positive results in accordance with the requirements of the WHO, authoritative international NGOs and practices of the leading countries of the world.Thus, the formation of adequate PHC considering multidisciplinary approach, WHO's recommendations and experience of leading world countries is needed for an effective implementation of modern organizational and functional models of the Ukrainian PHC.

Conclusions
1.The content-analysis of the current Laws of Ukraine and some documents of WHO, the Council of Europe, ЕАРС, ІАНРС and other authoritative international institutes on the PHC organization allowed us to identify positive trends, in particular, the legislative ap-proval of palliative care in Ukraine as a type of medical care, but only in relation to incurable patients with limited predictive life expectancy, and this fact goes in to a discrepancy with modern international documents.
2. The main shortcomings of the acts regulating the PHC organization delivery in Ukraine are the lack of systematic and coordinated regulatory norms, the uncertainty of the criteria of PPs with different nosologies, the lack of mechanisms for determining the status of PPs, the problems of the organization of the PHC providing for incurable sick in both in-patient and out-patient conditions and at home.
3. The aforecited statements require the urgent development and approval of the Order "About the Procedure for the Providing of Palliative Medical Care to the Population in Ukraine and the List of Medical Indications for Its Delivery" by the MOH of Ukraine, in which mechanisms and coordination of the various levels of medical care providing, standards of palliative care and maintenance of various category of PPs, criteria for the status of PPs definition, etc should be determined.
4. In order to optimize Ukrainian legislation in its part of the PHC providing organization to the population of Ukraine, there is an urgent need for the elaboration and adoption of a Law of Ukraine "About Palliative Care" by Ukrainian Parliament, in which the priorities of state policy, adequate financing of PHC from the State and Regional Budgets and extrabudgetary sources, clearly outline the system of such type of care, determine the state regulation of the provision of PHC, provide a systemicity, continuity and structuring of Ukrainian PHC, help to eliminate inter-departmental barriers on personnel policy issues, provide motivation for specialists in PHC training, PPs and their families with adequate drugs, care facilities, social, psychological and spiritual support etc.
5. An extremely urgent task that will ensure the development of an accessible, high-quality and efficient PHC System is the development and approval of the "State Social Program for the Development of Palliative and Hospice Care in Ukraine" by the Cabinet of Ministers of Ukraine and Parliament of Ukraine.This document will help to realize a right of palliative patients and their families members for appropriate quality of life and its worthful ending.
Conflict of interest.The author declares that there is no conflict of interest in the preparation of the article.

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system of palliative and hospice care; palliative and hospice medical care; palliative care; status of a palliative patient; normative-legal base; legislation of Ukraine; WHO; Council of Europe Соціальна медицина / Социальная медицина / Social medicine [17], O. Detsyck and Zh.Zolotareva (2013) [18], V. Chaykovska (2013) [19], R. Moiseyenko et al. (2015) [20], I. Senyuta (2017) [21] and others.But it should be noted that systematic research on a legal regulation of the PHC provision organization to the Ukrainian population was not found in any accessible literature.The legal regulation of the PHC supply to the population of Ukraine at the country level is carried out by the relevant Laws of Ukraine, Decrees of the President of Ukraine, Resolutions of the Cabinet of Ministers of Ukraine, Orders of the Ministry of Health of Ukraine and the Ministry of Social Policy of Ukraine.To date, in Ukrainian Legislation, provision of PHC to the population is determined and regulated by several Laws of Ukraine.Introduction of the Law of Ukraine "On the Basis of the Legislation of Ukraine on Health Care" dated 19.11.1992,No. 2801-XII, (Section V. "Medical Care ", Article 33 "Provision of Medical Care") in 2011, a new type of medical care -"Palliative Care" can be considered as a new stage in the development of the Ukrainian healthcare area.
parameters are also regulated by the Order of the Ministry of Social Policy and MOH of Ukraine dated 23.05.2014, № 317/353 "About Approval of the Procedure of Co-operation of Subjects in the Provision of Social Services for Palliative Care at Home" (registered by the Ministry of Justice of Ukraine dated 06.13.2014,No. 625/25402).According to this Order, the main coordinators of work on the provision of social services for palliative care at home are identified as Territorial Centers of Social Services for the Population.At the same time, it should be noted that the expansion of the list of social services in palliative care that are provided by Territorial Centers, requires additional staff units with the appropriate skills level.It is necessary to provide adequate financing from the State Budget to Territorial Centers for the organization of palliative care at home providing.The Resolution of the Cabinet of Ministers of Ukraine dated 21.11.2013,No. 896, "About Approval of the Procedure for the Detection of Families (Persons) in Extreme Living Conditions, Providing of Social Services and Social Execution Support for Such Families (People)" and the Order of the Ministry of Social Policy of Ukraine dated 31.03.2016,№ 318, "About Approval of the State Standard of Social Support for Families (Individuals) Who Are in Difficult Circumstances" (registered with the Ministry of Justice of Ukraine dated 04.22.2016,# 621/28751) are very important acts about the provision of PHC to patients and their families at home by staff and they should be considered when developing the Order "Procedure for Palliative Medical Care in Ukraine and a List of Medical Indications for Its Providing " by the MOH of Ukraine.
About State Financial Guarantees of Population Medical Care", in which the Article 4 of the "Medical Guarantees Program" says: "1.Within the framework of a Medical Guarantees Program , the state guarantees citizens, ... full payment for all expense for necessary medical services and medicinal products related to the provision of it from the State Budget of Ukraine. 5. Palliative care; ...".Now the MOH of Ukraine should urgently develop an order "About the Procedure for the Palliative Care Provision", in which to approve the mechanisms of the implementation and enforcement of this Law.