Healthcare

1. Evaluation of reform policies of the Parliament and Government during the period of September 2019 – January 2020 and its compliance with the Toronto Principles (based on the analysis of the Government Program, the plans of the ministries and the adopted/rejected regulatory acts)

In autumn 2019, the program of activities of the Cabinet of Ministers of Ukraine (hereinafter - CMU)[1] declared the achievement of three key goals: "Goal 2.1. People get sick less; Goal 2.2. People who get sick recover faster; Goal 2.3. People live longer "- with appropriate performance indicators. However, in early March 2020, the Government of Oleksiy Honcharuk resigned, so it is no longer necessary to evaluate this program. Until June 2020, the new government operated without an approved program. The new program in the field of health care, approved by the CMU on June 12, 2020 № 471[2], consists of three parts: priority measures aimed at overcoming the COVID-19 pandemic, measures to reform the healthcare system, and measures ensure equal access to quality medical care for citizens with chronic non-communicable diseases (not related to COVID-19).

Short-term priorities include preparing the network of healthcare facilities to work in special conditions, providing the necessary medical equipment, medicines and materials, creating additional places of medical care and restoring the functioning of the anti-epidemic protection system.

The following expected results and indicators are among the strategic priorities:

• ensuring the provision of a state-guaranteed list of medical services;
• introduction of electronic documentation in electronic form;
• improving the quality of practical training of interns and as a result - improving the quality of medical care;
• improving the quality of education of medical workers in the system of continuous professional development;
• regulation of the system of certification of paramedical staff and introduction of continuous medical development;
• introduction of an indicators system of medical care quality;
• restoration of the system of anti-epidemic protection and ensuring the sanitary and epidemiological well-being of the population;
• reduction of mortality;
• improving the quality of medical services provided to the population;
• functioning of an accessible and capable network of specialized health care institutions for the provision of quality medical services;
• expanding the access of patients using the Affordable Medicines Program to new medicines and ensuring patients' access to quality and safe medicines.

The policy of health care reform for the period September 2019 - September 2020 should be assessed in terms of achieving the strategic objectives of the reform - development and improvement of primary care and launching the reform of secondary care, which was to begin on April 1, 2020. Also, the reform cannot be assessed without taking into account the COVID-19 pandemic, which introduced significant objective adjustments to political priorities, as well as the manipulation of the COVID-19 factor and public finances in the political interests on the eve of local elections[3].

Progress in health care reform

Primary healthcare. The funding mechanisms of health care institutions and doctors providing primary care (hereafter – PHC) are modified according to the principle “Money follows the patient” is applied in full. Budget expenditures in primary health care have increased: from 10.6% of healthcare spending in 2017 to 14.6% in 2019. At the end of August, the National Health Service of Ukraine (hereinafter - NHSU) concluded agreements on the provision of PHC with 1,652 service providers, which is 10% more than at the end of 2019. The share of privately-owned providers has increased: 199 private health care facilities (hereinafter - HCF) (15% growth) and 355 individual practitioners (family doctors) (40% growth compared to the end of 2019) have concluded agreements with the NHSU on the provision of PHC. Growing competition in the healthcare market is affecting their quality: institutions are beginning to focus on the needs of the patient, because only the patient can invite money to the institution. However, it is important to assess the quality of PHC, coverage of PHC services and a possible revision of the list of guaranteed PHC packages, as services such as primary prevention and short interventions, healthy lifestyle counselling are often ignored by family doctors.

Transformation of secondary (specialized) health care. As noted above, 2020 is a turning point in the implementation of the second stage of health care reform. In order to implement the program of medical guarantees, which from 1 April 2020 includes primary, outpatient, inpatient, emergency, palliative care, medical rehabilitation and reimbursement of drugs ("Affordable Medicines"), the CMU adopted the regulation "On approval of the Procedure for the implementation of state guarantees of health care under the program of medical guarantees in 2020" of November 27, 2019 № 1124[4], which determines the list of medical services and types of medical care for which health care facilities may enter into agreements with the NHSU, and the Methodology for calculating tariffs[5], which determines the mechanism for calculating tariffs under the program of state guarantees of medical care.

In addition, a list of health care facilities in hospital districts for the period up to 2023 has been approved[6]. For the first time, the procurement list for 2020 was created using a health technology assessment methodology (health technology assessment), which enables public procurement based on clinical performance, cost-effectiveness and organizational problems with the use of pharmaceuticals, medical devices and other medical technologies.

Affordable Medicines Program. As of the end of August, 1 192 pharmacies operated under this state program, which is 50% more than at the beginning of 2020. The overall increase in patients who benefited from the Affordable Care Act is almost 60% (from 1.49 million in October 2019 to 2.35 million patients in September 2020) (the program is designed for patients who have cardiovascular disease, type II diabetes and bronchial asthma. 11.19 million electronic prescriptions have been handed already, 9.39 million (84.38%) of them have been repaid. The largest number of prescriptions was handed out for the treatment of cardiovascular diseases (almost 8.940 million), followed by diabetes (over 1.860 million) and bronchial asthma (over 332 thousand)[7]). The list of medicines available on the program includes 254 pharmaceuticals, 78 of which can be obtained free of charge and others with a small additional cost. For further implementation of this program, the Resolution of the Cabinet of Ministers of Ukraine “On Amendments to the Procedure for Determining the Amount of Reimbursement of Medicinal Products”[8] № 1069 was adopted.

e-Health. The introduction of the eHealth system continues. Among the institutions and providers of PHC that have concluded an agreement with the NHSU, the level of computerization has increased to 92%. Since September 2019, more than 50 primary care facilities have joined the testing of electronic medical records according to the ІСРС-2 classification. One of the Government's priorities is the introduction of electronic medical records.

Emergency health care. The CMU approved an action plan for the implementation of the Concept for the Development of the Emergency Medical Care System[9]. The information-analytical system "Central 103" is being developed. 23 regions of Ukraine are already connected to this system. The software of the central operational and dispatching services gives the chance to see the nearest free car on GPS.

Transplantation. The foundation for the development of transplantology in Ukraine has been laid down. The implementation of transplantation is regulated by law: amendments have been made to some legislative acts regulating the issue of transplantation of anatomical materials to humans[10]. In addition, a number of regulations[11] have been adopted, as well as the tariffs[12] for organ and bone marrow transplants in Ukraine, which will greatly simplify the transplantation process in Ukraine.

In the field of medical education, a threshold for admission to medical specialties has been introduced, and a resolution of the CMU on a single state qualification exam for physicians has been adopted. Work to improve the quality of education in the specialty of "public health" is underway, in particular, a single state qualification exam for applicants for a degree in this specialty is being developed.

Public health. In order to further develop the public health system, harmonize Ukrainian legislation with international and European standards in the field of combating infectious and non-infectious diseases, a number of legal documents were adopted in November 2019, including:

• Strategy and action plan for biosafety and biological protection on the principle of "Single Health" for the period up to 2025[13]. The measures should increase the level of biological safety and biological protection in Ukraine. The priority will be to harmonize Ukrainian legislation with international law (especially the EU) in the field of biosafety and biosecurity.
• Strategy and action plan for the development of immunoprophylaxis and protection of the population from infectious diseases. Measures should increase the population's commitment to vaccination, strengthen the effectiveness of the infectious disease surveillance system, and increase vaccination coverage.
• National Strategy for Combating HIV / AIDS, Tuberculosis and Viral Hepatitis until 2030[14], which will help to overcome the epidemics of HIV / AIDS, tuberculosis and viral hepatitis B and C.
• Action plan to reduce the level of exposure of the population to radon and its decay products, minimize long-term risks from the spread of radon in residential and non-residential buildings, workplaces for 2020-2024[15].

Together with existing strategies for public health development, noncommunicable disease control, antimicrobial resistance and blood system development, these documents create unprecedented commitments and frameworks for public health reform and development.

2. Key challenges in implementation of the reform

The challenges that Ukraine faces in implementing the reform have both a sectoral and a political basis. Since the launch of the health care reform, some political forces have repeatedly sought to discredit the reform agenda and block a number of fundamental innovations.

The election of a new President and Parliament, held in 2019, with a further change in the composition of the CMU twice, and the leadership and composition of the Ministry of Health of Ukraine (hereafter – MHU), have become a cause for public concern because of political messages about the retreat from the selected vector of transformational processes in the healthcare sector[1]. It seems that the Government is following the momentum of the changes launched in 2017-2019, criticizing the reform, but not proposing other viable initiatives. Therefore, the main tasks for 2020-2021 is to ensure the continuity of the changes in the system, consolidate the results already achieved and increase the pace of reform in accordance with the National Strategy for Health Care Reform in Ukraine for the period 2015-2020[2].

The sectoral challenges of the reform are the risks associated with the financial and organizational failure of certain sectors of specialized health care (such as phthisiological, psychiatric), which may lead to a worsening of access to quality care for certain groups of the population, as well as downsizing and optimization of second- and third-level health care facilities under the conditions for their autonomisation that may lead to dismissal of medical personnel. At the same time, such risks cannot create the ground for postponing decisions on optimization of institutions and changing the format of funding, because in the current situation in most cases (mentioned above phthisiology, psychiatry) patients do not have access to quality services.

Financial challenges and risks: expenditures of the consolidated budget of Ukraine on health care increased by UAH 70.4 billion – this growth is rather nominal, which is explained by the rate of inflation, not the real increase of expenditures, since in the percentage of total expenditures of the consolidated budget on health care does not show upward trends, and worse still – decreases. Hence, if in 2014 this figure was almost 11%, in 2019 it was a little less than 9%[3]. The main task for 2020 is to increase the level of funding for health care to 5% of GDP, further transition from a subsidy approach to payment for services, including in the field of public health.

Political challenges: The rapid change in the leadership and structure of the MHU poses significant challenges to its capacity to reform according to the determined plans. The political statements of the leadership of the MHU send false messages about possible changes in the vector of health care reform, especially in specialized and highly specialized medical care, which is being strongly opposed. It is important to note that significant changes took place only at the level of primary health care, which had almost no effect on the level of free medical care for the population. After all, the lion's share of unofficial payments has always been at the level of specialized and highly specialized medical care and mainly in the hospital sector.

Therefore, it is extremely important to preserve the legislative prerequisites for vital changes in the domestic health care system by further implementing the provisions of the Law of Ukraine "On State Financial Guarantees of Medical Care" № 2168-VII.

Minister Stepanov's statements about the unfoundedness of some NHSU tariffs in early April allowed institutions that were unable to contract with the NHSU to demand funding outside the new system, which eventually led to "double" funding for some HCFs. This situation demotivates the leadership of the HCF, which has made significant efforts to prepare for the reform in time. Therefore, by the end of 2020, some HCFs will continue to receive funding "for walls and beds", although under contracts with the NHSU. Naturally, after 1 January 2021, this situation needs to be corrected, and all HCFs should have the same conditions for funding under the new rules.

Revision of tariffs for services is possible provided that the funding for health care will increase, which will not happen in 2020. Hence, it is still unknown how much tariffs for services will increase in 2020.

Overall, the rhetoric of the new leadership of the MHU (all three ministers since September 2019) on the reform was more concerned with the problem of doctors than patients. A certain departure from the patient-centric health care reform can be identified, which is a threatening trend.

The COVID-19 pandemic has brought a new priority perception of the public health sector, as well as raised the issue of restoring the sanitary-epidemiological service. At the same time, the draft law on public health has not yet been submitted by the MHU for coordination with central executive authorities. There is an acute question about the functioning of the newly created regional public health centers and their funding in 2020, as well as the role and functionality of the regional laboratory centers of the MHU in the future system. The answers to these crucial questions must be provided today.

In addition, there are a number of critical issues in other areas of public health, such as the development of the blood service. The current system of reforming HCFs does not take into account the specifics of blood center activities and does not provide answers to the question how blood and its components will be supplied by blood centers of HCFs and at what price.

Also, while directing at the European integration, the MHO has developed and the CMU adopted a draft law on the implementation of the EU Directive No. 40 On Tobacco Control in December 2019. Unfortunately, due to delays and internal lobbying, the bill was never registered in the Parliament.

Procurement of medicines has also become one of the most problematic issues of the relevant ministry due to the conflict with the State Enterprise "Medical Procurement", created specifically for the centralized procurement of medicines. Currently, the Minister declares the absence of conflict and inefficient operation of the enterprise, and the management of the Enterprise - the pressure exerted by the Minister. This situation has already led to disruptions in the supply of contracted drugs, which puts patients at risk. Accordingly, it is necessary to immediately establish a procurement system through the State Enterprise "Medical Procurement" as a specialized enterprise.

3. Recommendations for priority actions in 2020-2021, in particular, for the agenda of Parliament's fourth session

Reforming the national health care system is a fundamental change in the organizational and economic management principles in line with market requirements and European standards. The first stage – reforming the primary care unit – is completed. Further implementation of health care reforms should focus on the following steps:

• to initiate the assessment of the quality of primary health care provision and introduce appropriate changes and adjustments to the volume of PHC provision based on its results;
• to complete the implementation of new financial mechanisms on a “Money follow the patient” basis at the level of specialized and highly specialized medical care (ambulatory and inpatient levels) for all HCFs without exception from 2021;
• to perfect the mechanism of patient routing;
• to establish an effective emergency medical care system that meets the international standards: to develop and adopt the Good Samaritan Law, to update the technical, information and personnel support of the service, to equip dispensaries and intensive care hospitals in accordance with the international standards;
• to complete the digitization of the industry - ensure complete electronic flow of documents in the healthcare system;
• to establish the transplant system and ensure its development in Ukraine;
• to continue the development of a public health system, especially in areas such as the prevention of non-communicable diseases, the strengthening of tobacco control legislation through the implementation of the WHO Framework Convention on Tobacco and EU Directives 2014/40 / EC and 2011/64 / EC implementing the European standards and practices in the blood system as well as in the surveillance system for infectious diseases, ensuring maximum coverage by immunoprophylaxis;
• to create a single biosafety and biosecurity system aimed at protecting human health and the environment from the effects of hazardous biological agents, in particular those that could lead to emergencies and threaten national and international security; to initiate drafting the Law of Ukraine "On Biosafety";
• to ensure the development of a system for the evaluation of medical technologies that will allow to implement effective strategic in the field of health care based on indicators of clinical effectiveness, economic feasibility and organizational problems of the use of pharmaceuticals, medical devices and other medical technologies;
• to complete the reform of medical education at all levels in line with European standards – for nurses, physicians, and management;
• to introduce a system of professional licensing for physicians and ensure the development of medical self-government as an institution for regulating the quality of health care services and protecting the rights of healthcare professionals;
• to ensure implementation of the International Classification of Functioning, Disability and Health (ICF) and launch a full-fledged rehabilitation and disability determination reform (MSEC);
• to urgently and immediately establish an effective system of procurement of medicines, including under the international contracts, involving SE "Medical Procurement" in this process;
• to provide a transparent competition for leading positions of the NHSU, the Center for Public Health, heads of the MHU structural subdivisions, in accordance with the current legislation;
• to introduce the general approach “Health in All Policies”, as declared in the Association Agreement between Ukraine and the European Union.