ROMANIA: Advisory Services Agreement on Strengthening Planning and Budgeting Capacity and Supporting the Introduction of Performance Budgeting

Output No. 2 Institutional Strategic Plan 2017-2020 for the Ministry of Health

April 2017

Project co-financed from European Social Fund through Operational Programme for Administrative Capacity 2014-2020

Competența face diferența! Proiect selectat în cadrul Programului Operațional Capacitate Administrativă cofinanțat de Uniunea Europeană, din Fondul Social European Competence makes a difference! Project selected under the Administrative Capacity Operational Program, co-financed by European Union from the European Social Fund

Disclaimer This report is a product of the International Bank for Reconstruction and Development / the World Bank. The findings, interpretation, and conclusions expressed in this paper do not necessarily reflect the views of the Executive Directors of the World Bank or the governments they represent. The World Bank does not guarantee the accuracy of the data included in this work. This report does not necessarily represent the position of the European Union or the Romanian Government.

Copyright Statement The material in this publication is copyrighted. Copying and/or transmitting portions of this work without permission may be a violation of applicable laws. For permission to photocopy or reprint any part of this work, please send a request with the complete information to either: General Secretariat of the Government, Directorate for Coordination of Policy and Programs, 1 Victoriei Square, Bucharest, Romania or (ii) the World Bank Group Romania (Vasile Lascăr Street, No 31, Et 6, Sector 2, Bucharest, Romania)

This report has been delivered under the Advisory Services Agreement on Strengthening Planning and Budgeting Capacity and Supporting the Introduction of Performance Budgeting signed between the between the General Secretariat of the Government and the International Bank for Reconstruction and Development, signed on June 8, 2016. It corresponds to a deliverable, which contributes to Output 2 under the above-mentioned agreement.

ACKNOWLEDGEMENTS

This report was prepared by a team led by Catalin Pauna (TTL) and included Cristina Petcu, Radu Comsa, Costel Todor, Mihai Vilnoiu, and Raluca Banioti. The report benefited from thoughtful comments from Gary Reid, Marcelo Bortman and Corina Grigore, and overall guidance from Ivailo Izvorski and Elisabetta Capannelli.

The team would like to thank the staff at the General Secretariat of the Government for the support and excellent collaboration provided throughout the elaboration of this report, and in particular to Mr. Radu Puchiu, state secretary, and Mr. Dragos Negoita, general director. Counsellor Radu Iacob and the project team provided outstanding advice and project management.

The team wished to acknowledge the support and contributions made by the members of the working group set up with the task of developing and implementing the Institutional Strategic Plan for the healthcare sector, including experts from the Ministry of Health, the National Health Insurance House, National Authority for Health Quality Management, National Public Health Institute and National School for Public Health, Management and Training in Healthcare. The team wishes to thank in particular to Mrs. Corina Pop, state secretary in the MoH, Mr. Radu Țibichi, general director of the NHIH, Mrs. Mihaela Bardoș, head of the NAHP, and Mrs. Monica Isăilă, head of the Public Policy Unit, for their involvement and cooperation.

Acronyms AIDS Sindrome de l’Immuno-Deficience Acquise DALY Disability Adjusted Life-Years DCPPHI Department for Centralized Procurement, Property and Healthcare Infrastructure DHMS Department for Healthcare Management and Structures DMMDP Department for Medicine and Medical Device Policy EMS Emergency Medical Service EU European Union GD Government Decision GDBA General Department for Budget and Accounting GDHAPH General Department for Healthcare Assistance and Public Health GDHRLAD General Department for Human Resources, Legal and Administrative Litigation GEO Government Emergency Ordinance GO Government Ordinance GSG General Secretariat of the Government HIV Human Immunodeficiency Virus HRD Human Resource Development ISP Institutional Strategic Plan MARD Ministry of Agriculture and Rural Development MoH Ministry of Health MoNE Ministry of National Education MoPF Ministry of Public Finance NAHP National Agency for Health Programs NAHQM National Authority for Health Quality Management NAMMD National Agency for Medicines and Medical Devices NGO Non-Governmental Organization NHIF National Health Insurance Fund NHIH National Health Insurance House NHS National Health Strategy 2014-2020 NICE National Institute for Care Excellence NIS National Institute for Statistics NPHI National Public Health Institute NPHSA National Program for Health Status Assessment NSPHMTH National School for Public Health, Management and Training in Healthcare OEC Operative Emergency Center OPAC Operational Program Administrative Capacity OPC Operational Program Competitiveness OPHC Operational Program Human Capital OPR Operational Program Regional SHI State Healthcare Inspection WHO World Health Organization

Table of contents Table of contents ...... 5 1. Context ...... 6 2. Mission and Vision ...... 10 3. Strategic Objectives, Programs, Measures, Indicators ...... 11 Strategic objective 1: Improving the health of the population through measures of morbidity prevention and control ...... 11 Program 1.1: Prevention and control of non-communicable diseases ...... 15 Program 1.2: Prevention and control of communicable diseases ...... 16 Program 1.3: Improving mother and child health ...... 18 Program 1.4: Monitoring public health in connection with the environment ...... 19 Strategic objective 2: Cross-cutting measures to increase the performance of the healthcare system ...... 21 Program 2.1: Ensure the functional framework and resources for the healthcare system ...... 26 Program 2.2: Improve the efficiency and quality of healthcare services ...... 28 Program 2.3: Ensure patient access to medicine and medical devices...... 30 Program 2.4: Upgrade the healthcare system infrastructure ...... 32 Strategic objective 3: Develop the institutional capacity of management structures in the healthcare system ...... 34 Program 3.1: Improve the performance of strategic, regulatory and administration institutions in the healthcare system ...... 37 4. Arrangements for implementation, monitoring and evaluation of the ISP ...... 39 5. Financial resources ...... 41 Annex 1a: Budgetary Programs and Financial Resources by financing source 2017-2020 (thousand RON) .. 43 Annex 1b: Budgetary Programs and Financial Resources by main credit officer 2017-2020 (thousand RON) ...... 44 Annex 1c: Measures and Financial Resources by financing source 2017-2020 (thousand RON) ...... 45 Annex 2: Institutional Strategic Plan (Summary Table) ...... 48 Annex 3: Programs and Related Measures (Summary Table) ...... 55 Annex 4: Institutional profile, internal and external assessment ...... 86 Main determinants of the health status ...... 86 Institutional arrangements and capabilities referring to sector development ...... 87 Institutional profile...... 89 MoH subordinated institutions ...... 89 NHIH subordinated institutions ...... 90 Pieces of legislation to be developed and approved in 2017 ...... 90 Main pieces of legislation in the health sector ...... 91

1. Context The Romanian healthcare system relies on social health insurance, which coexists with public health interventions and private provision of services. Overall, spending has averaged between 5% and 5.5% of GDP over the last 10 years, with 80% of the total from public sources, mainly social health insurance, and 20% from direct payments. The level of spending places Romania at the bottom of the EU-28, significantly lower than the EU average of 8.4% of GDP.

Healthcare is regulated by a complex array of legislation of which the most important is Law no. 95/2006 on healthcare reform. Apart from the latter, over 25 pieces of primary legislation and numerous by-laws set provisions for the organization, delivery, financing and evaluation of health and health-related services and institutions. The complexity of legislation oftentimes impairs the behavior of service providers and regulatory bodies alike and, as a result, has a distortive impact on quality and access to services1.

A National Healthcare Strategy was approved in 20142 outlining the main challenges, priorities and objectives of the sector until 2020. The Strategy includes a detailed Action Plan with activities, indicators and estimated financial needs for all components of the sector.

The main public stakeholders in the healthcare sector are the Ministry of Health, the National Health Insurance House, the National Public Health Institute, the National Agency for Medicines and Medical Devices, and the National Authority for Health Quality Management3.

The MoH is mainly responsible for preparing the strategy and regulating the sector, but also retains significant responsibilities in service provision and financing. To this end, it runs 53 hospitals, ambulance service, emergency care and 15 national public health programs. MoH also finances a significant part of the capital investment of public hospitals. At the county level, MoH has 42 county health departments (including the city of Bucharest). The NHIH is the single payer in the social health insurance market. It runs 42 county health insurance houses (including in the city of Bucharest) and the insurance house for defense, public safety and justice employees. The NHIH is an autonomous institution under the coordination of the MoH. The head of the NHIH is appointed by the Prime Minister. The NPHI is responsible for the development and enforcement of public health policies. It plays a major role in epidemiological surveillance and control and health promotion. It is subordinated to the MoH. The NAMMD is the regulatory and authorizing body for drugs and medical devices. It conducts pharmacovigilance and health technology assessment for medicines. It is subordinated to the MoH. The NAHQM is responsible for developing and enforcing accreditation standards applicable to all service providers. It is subordinated to the government.

Box 1 – main tasks of the regulatory bodies in healthcare

In terms of human resources, the MoH and its subordinates employ 6,000 staff, while NHIH employs over 3,000 staff. The MoH also runs the ambulance services, which employ over 11,000 staff. In 2015 total public funding for healthcare amounted to 28 billion RON, i.e. 4% of GDP. The NHIF has historically accounted for more than 80% of public funding of healthcare, with most of its resources being allocated to hospital services and reimbursed medicines (see Figure 1&2).

1 A list of full-name regulations in the healthcare sector is available in Annex 5. 2 Government Decision no 1028/2014 on the National Health Strategy for 2014 - 2020 and the Action Plan. 3 A complete list of the public bodies in the healthcare sector is provided in Annex 5.

2% 13.7%

16% 37.4%

37.6% 82% reimbursed drugs

out-patient services 11.4%

hospital care

other spending (dialisis, emergency, medical leave, medical NHIF MoH local governments goods)

Figure 1 – structure of public financing of healthcare Figure 2 – structure of NHIF spending in 2015 in 2015 (source: MoF) (source: MoF)

As for the human resources across the entire healthcare sector, recent data published by the NIPH for 2015 counted a total number of 302,000 professionals, of which 56,000 were physicians and 132,000 nurses. The breakdown by type of provider reveals that 60% of physicians and close to 70% of nurses work in public settings.

In comparison to the other countries of the EU, the size of Romania’s healthcare personnel is lagging behind. The number of physicians per 100,000 population stands at 271, which represents 77% of the EU average4. To make matters worse, both physicians and nurses have been migrating to better-off EU countries in search for improved remuneration and working conditions. Data on the yearly dynamics of physicians’ cohort indicates between 1,000 and 1,500 persons emigrating yearly throughout 2009-2015. As a result, the annual growth rate of physician number at national level decreased from 4% in 2008 to less than 2% in 2013 and 20145.

The constraints related to cohort size are amplified by the skewed distribution of workforce across the country. Comparisons between predominantly rural and urban counties indicate an average rate of physicians per 100,000 population more than double in the latter, i.e. 383 to 170. For nurses, the difference is smaller, but remains significant: predominantly urban counties have 30% more nurses per 100,000 population than predominantly rural counties. An additional distortion concerns the overstaffing in counties where medical universities are placed. The lack of effective incentives for practicing in rural and economically worse-off urban communities led to a concentration of almost half of all physicians in six out of 42 counties (including the city of Bucharest). As a result, the counties in the top decile have four times more physicians than those in the bottom decile6.

The prevalent delivery model in healthcare is service provision, which absorbs 93% of all public funding in the sector. Half of funding is disbursed or transferred to health service providers in outpatient and inpatient care and 30% to pharmacies. In the vast majority of cases, the providers are contracted either by the health insurance houses or the county health departments. As for the services directly provided, the most important is the ambulance, which accounts for 2% of total service provision.

4 Eurostat, healthcare resources database, data available for 2006-2014. 5 National Statistics Institute, Tempo database. 6 Ibid.

Operational management of the healthcare sector is comprised of administrative costs – i.e. payroll and running costs of regulatory institutions – and transfers to individuals, e.g. sick leave allowances. The former accounts for only 2% of total spending.

The biggest service purchaser is the NHIH, whose health insurance houses sign contracts with more than 25,000 providers every year. While the vast majority of NHIH providers are private, especially in outpatient care, around half of the funds are eventually disbursed to public providers, i.e. hospitals7 and their outpatient clinics.

Population health status

As a result of the negative balance between birth, death and migration, the resident population of Romania has significantly decreased between 2002 and 2015 (from 21.6 down to 19.8 million inhabitants). In parallel, the nominal and relative decrease of the young and increase of those over 60 (up to 23.9% in 2015) have led to the ageing of the population.

Life expectancy at birth – a measure of the quality of life and an indicator of the potential yield of investments in human capital – has had a favorable evolution in the past two decades for both genders, and has currently reached 71.4 years for men and 78.7 years for women8. According to life expectancy, Romania ranks second to last in the EU-28, with the gap from the EU average wider for men (-6.7 years) than women (-4.9 years)9.

The needs which the Romanian health system must satisfy have changed as a result of the demographic and epidemiologic transition which took place in the country. The burden of morbidity in Romania, previously dominated by illness among mothers and children and by communicable diseases, has been overtaken by chronic and non-communicable diseases. The predominance of chronic, non-communicable diseases (NCDs), especially cardio-vascular diseases (CVD), diabetes, cancer and chronic respiratory diseases, continue to increase rapidly and, with it, invalidity rates.

Causes of death10. The latest data on the causes of death reveals that diseases of the circulatory system and cancer have been the main causes of death in Romania for the last two decades. The mortality generated by circulatory diseases has reached 58.9% by 2015, while that of neoplasms 19.7%. The following causes of death, in order of frequency, are diseases of the respiratory system (5.7%), digestive system (5.5%) and external causes11 (3.7%).

The main causes of death differ by age group. For teenagers and young adults, the primary causes of death are external (also including road accidents). From 45 years old onwards, diseases of the circulatory system, tumors and diseases of the digestive system prevail. Deaths caused by the above-mentioned pathologies are significantly higher in Romania than the EU average, which may point to systemic failures in preventive services.

Infant mortality maintained its decreasing trend down to a minimum level of 8.4 deaths per 1,000 live newborn babies in 2014, but still continues to be the highest rate in EU-28 countries and 2.3 times the

7 Of the 367 public hospitals, 53 are owned by the MoH and rest by local governments, mainly county councils. 8 Eurostat, 2014. 9 Ibid. 10 Detailed information on the causes of death and morbidity are available in annex 6. The source of data is the statistical center of NPHI. 11 Traumatic lesions, poisoning or other external causes.

European average (~3.7‰ in 2014). The most frequent causes for infant death relate to perinatal conditions, respiratory diseases and congenital pathology. Remarkably, mothers’ deaths per 100,000 births dropped considerably from 77 in 2000 to 27 in 2015, but remains significantly above the EU average.

2. Mission and Vision

The Ministry of Health, the National Health Insurance House and the National Authority for Health Quality Management are the central authorities for healthcare in Romania, responsible for the formulation of polices, strategies and action plans in healthcare; coordinating and monitoring their implementation thereof at national, regional and local levels; implementation of healthcare reforms; delivery of health services at adequate quality levels.

The Mission of the institutions tasked with healthcare policy formulation and administration is: to prepare and implement strategies, policies and programs to promote public health and the development of a modern and highly performing health system, in line with the population’s needs and compatible with EU standards.

 A highly performing healthcare system requires equitable access to cost-efficient and high-quality health services, with a focus on prevention.  Achieving a highly performing system requires appropriate, consistent and stable public policies, supported by broad consensus of healthcare service providers, and upgrades of obsolete and outdated medical infrastructure.  National healthcare policies need to be integrated within the EU’s framework. This does not mean passively adopting EU policies, but rather actively promoting solutions suitable for Romania’s needs and agreed with national partners.  Dedicated support to promote public health generates benefits for Romania, but also for the region. Such benefits should exceed the short- and long-term costs of this support, which confirms the responsibility to prepare consistent and sustainable public policies and sectoral strategies.

The Vision of the institutions tasked with healthcare policy formulation and administration is: to serve the interests of the population and respond to its needs by facilitating access to high-quality preventive and curative services with effective and efficient distribution and use of resources, that results in a nation of healthy and productive people.

 To develop the healthcare system by putting the patient at its core and bring service provision as close as possible to his home.  To undertake responsibilities with the highest standards of transparency, liability and integrity, in cooperation with other public institutions, the private sector, professional associations of physicians, pharmacists, nurses and other healthcare professionals.  To improve the managerial and organizational performance, to comply with its responsibilities set forth in the Governance Program, sectoral strategies and policies.  To pay due attention to the concerns, opinions and dialog with citizens and monitor the impacts of decisions to enable adjustments as needed to better meet the public’s requirements.

3. Strategic Objectives, Programs, Measures, Indicators

Strategic objective 1: Improving the health of the population through measures of morbidity prevention and control

Romania has a mixed health profile. It resembles developed countries as a result of the high burden of chronic diseases, but also developing countries, given the significant burden of certain communicable diseases (e.g. tuberculosis, viral hepatitis B and C, inherited prevalence of HIV/AIDS).12 Moreover, the surveillance and control of nosocomial infections and of antibiotic-resistance are insufficient and could potentially have a high impact on the quality and effectiveness of health services.

The high prevalence of behavioral determinants of health - smoking, alcohol abuse, diet/obesity and physical inactivity – weigh heavily on the health status of the population and lead to higher mortality rates than the EU-28 averages (see Figure 3). At present, health promotion activities are underfunded, unfocused and insufficiently based on evidence. To change behaviors for the better, a more coherent, targeted and better resourced approach is needed for health promotion programs. As a result, the National Healthcare Strategy 2014- 2020 requires the development and implementation of a national prevention plan which would combine health promotion and prevention interventions.

2,767

2,219

1,175

654 538 581 556

197 96 155

All causes of death -cerebrovascular -diseases of the Malignant neoplasms Diseases of the (A00-Y89) excluding diseases (45 years and cardiovascular system (C00-C97) (45 years digestive system (K00- S00-T98 (45 years and over) (45 years and over) and over) K93) (45 years and over) over)

European Union (28 countries) Romania

Figure 3 – Main causes of death in the European Union and Romania for adults over 45 years old (deaths/ 100.000 population) (source: Eurostat)

The NHS outlines cardiovascular diseases, cancer and diabetes as strategic sectoral priorities and mandates the development and implementation of specific national control plans which would integrate interventions across the entire spectrum of health services: primary and secondary prevention, treatment, monitoring, palliative care and long term care.

12 Bygbjerg IC, Double burden of noncommunicable and infectious diseases in developing countries. Science. 2012 Sep 21;337(6101):1499-501. 11

The NHS also puts emphasis on communicable diseases with the aim of monitoring, controlling reducing the burden towards EU average levels. As such, it makes a priority out of (i) strengthening the national system of surveillance and response, (ii) reducing the incidence of vaccination-preventable disease, (iii) reducing the morbidity and mortality rates from tuberculosis, HIV/AIDS and viral hepatitis.

Apart from high prevalence diseases, the NHS gives due importance to rare diseases. It mandates the development and implementation of a national plan for rare diseases, which would integrate interventions across the entire range of care, from clinical guidelines to genetic risk assessment, diagnostic and treatment, palliation and recovery services.

This strategic objective is made of programs and measures aiming to reduce the disease burden, advance healthy lifestyle and protect the population against environment risks to health.

1 Strategic objective: Improving the health of the population through measures of morbidity prevention and control

Program 1.4: Program 1.1: Program 1.2: Program 1.3: Monitoring public health Prevention and control of non- Prevention and control of Improving mother in connection with the communicable diseases communicable diseases and child health

environment

–

viral hepatitis viral

–

Measure 1.2.1.3 Strengthen the system of prevention, prevention, of system the Strengthen 1.2.1.3 Measure monitoring and treatment diagnostic, detection, surveillance, diseases communicable of priority

Measure 1.2.1.4 Strengthen the system of prevention, prevention, of system the Strengthen 1.2.1.4 Measure diseases communicable priority of control and surveillance AIDS HIV/

Measure 1.1.1.1 Develop and implement mechanisms for for mechanisms and implement Develop 1.1.1.1 Measure of control and treatment diagnostic, prevention, diseases cardiovascular

Measure 1.1.1.3 Develop and implement mechanisms for for mechanisms and implement Develop 1.1.1.3 Measure of diabetes control and treatment diagnostic, prevention, mellitus prevention, of system the Strengthen 1.2.1.2 Measure diseases communicable priority of control and surveillance tuberculosis

Measure 1.1.1.2 Develop and implement mechanisms for for mechanisms and implement Develop 1.1.1.2 Measure of oncologic control and treatment diagnostic, prevention, diseases

Measure 1.2.2.1 Protect the population health against main main against health population the Protect 1.2.2.1 Measure through prevented be can that diseases communicable vaccination

Measure 1.1.1.5 Promote a healthy lifestyle the combat and lifestyle healthy a Promote 1.1.1.5 Measure factors risk main

Measure 1.2.1.1 Strengthen the system of prevention, prevention, of system the Strengthen 1.2.1.1 Measure diseases communicable of control and surveillance

Measure 1.1.1.4 Prevention and control of mental and and of mental control and Prevention 1.1.1.4 Measure disorders behavior

Measure 1.1.2.1 Develop medical services for patients with with patients for services medical Develop 1.1.2.1 Measure pathologies special

Measure 1.3.1.2 Measures of early detection and assessment assessment and detection of early Measures 1.3.1.2 Measure autism as such incidence, increasing with diseases of child disorders spectrum

Measure 1.3.1.1 Early detection and assessment of risks during during risks of assessment and detection Early 1.3.1.1 Measure child and mother both for pregnancy

Measure 1.3.1.3 Measures Measures Measure aimed1.3.1.3 improving at child nutrition and other measuresfor specific diseases

Measure 1.4.1.1 Monitor and report on the determining determining the on report and Monitor 1.4.1.1 Measure environment working and living the from factors determining factors from the living and working environment working and living the from factors determining Measure 1.4.2.1 Consolidate monitoring services for the the for services monitoring Consolidate 1.4.2.1 Measure

•Reduce the gap between the life expectancy and healthy life expectancy in men from (Baseline) 12.4 years to Target 2020: 12.2 Target 2030: 12; Impacts •Reduce the gap between the life expectancy and healthy life expectancy in women Baseline: 19.7 years to Target 2020: 19.3 to Target 2030: 19;

• (1.1.1.) Reduce the prevalence of risk factors for non-communicable diseases: Standardized rate of deaths caused by chronic diseases in persons aged below 65 to drop from_219.15/100,000 to 217/100,000 • (1.1.2.) Ensure access to early detection, diagnosis and / or treatment for specific diseases: Coverage of target group for cervical cancer screening to increase from 9.2% to 10%; Cervical cancer incidence to vary from 34.24/100,000 to 34/100,000 • (1.2.1) Reduce the incidence and prevalence of priority infectious diseases: Standardized TB incidence 63/ 100,000 to 60/ 100,000; Standardized HIV incidence 1.99/ 100,000 to 1.9/ 100,000; Standardized hepatitis B incidence will drop from Programs' 1,11/ 100,000 to 1/ 100,000 • (1.2.2) Increase the compliance rate to the vaccinations included in the National outcomes Immunization Calendar: Vaccination coverage for children of 12 and 24 months as part of the national immunization calendar will increase from 80% to 85% • (1.3.1) Improve mother and child health: Infant mortality rate (0-1 years) to drop from 7,97/ 1,000 live births to 7.9/ 1,000 live births; Mother birth mortality will stay at 0.1/ 1,000 live births • (1.4.1) Reduction in diseases linked to environmental risk factors: Number of occupational diseases to drop from 1025 cases to 800 cases • (1.4.2) Reduction of the negative impacts of environmental catastrophes occurring at infrastructure sites exposed to environmental risks: Map of areas posing risks for human health to be developed and operational

Box 2 – Strategic objective 1: impact and outcome indicators

Strategic objective 1: Improving the health of the population 2017 2018 2019 2020 through measures of morbidity prevention and control Program 1.1: Prevention and control of non- 6.087.871 6.553.819 6.839.249 7.142.141 communicable diseases Program 1.2: Prevention and control of 1.850.795 2.134.166 2.799.135 2.859.451 communicable diseases Program 1.3: Improving mother and child 32.006 33.606 36.055 38.703 health Program 1.4: Monitoring public health in 1.838 27.522 60.974 2.447 connection with the environment Table 1 –Strategic objective 1: Breakdown of financing by budgetary program (thousand RON)

Program 1.1: Prevention and control of non-communicable diseases

Rationale. Romania’s population is decreasing and aging; it is estimated that, by 2050, the largest population segment will be made up of the elderly (aged 60 and above). The demographic changes place a significant burden on the health care system, as they are associated with a shift in epidemiologic patterns of each age group13.

The needs that the healthcare system must meet have changed following the demographic and epidemiologic transition of the last decades. While in the XXth century the morbidity burden in Romania was dominated by mother and child diseases and by communicable diseases, at present it is dominated by chronic and non-communicable diseases. Therefore, Romania faces the challenge of reprioritizing its health care efforts to give higher priority to addressing chronic and non-communicable diseases.

In the field of preventive medicine, Romania does not do well compared to other EU Member States. As emphasized by NHS 2014-2020, the healthcare system should focus on primary prevention, with the goal of decreasing the prevalence of risk factors, and on secondary prevention, with the goal of the early detection and treatment of the diseases before they become symptomatic, to avoid complications. To this end, it is necessary to gradually increase the percentage of prevention programs and activities in the budget of the health sector, with an emphasis on family physicians and outpatient services. The conclusion of the most recent evaluation of the efficiency of allocation conducted by international experts is that “there is a relative underfinancing of the primary care and outpatient services”14, which is associated with structural and financing anomalies.

Patients with chronic diseases tend to have more frequent and uncoordinated contacts with the health care system: diagnosis services, specialists, emergency rooms, outpatient clinics, pharmacies. Without a proper coordination and without an adequate algorithm for the care that their health status requires, chronic patients often fail to receive effective treatment in due time. This leads to acute complications, repeated or overlapping services, to the improper use of drugs, as well as to an increase in costs for individuals, for NHIF and for the state budget.

Objectives: Program 1.1 is intended to achieve the following results by 2020: - (1.1.1.) Reduce the prevalence of risk factors for non-communicable diseases: Standardized rate of deaths caused by chronic diseases in persons aged below 65 to drop from_219.15/100,000 to 217/100,000 - (1.1.2.) Ensure access to early detection, diagnosis and / or treatment for specific diseases: Coverage of target group for cervical cancer screening to increase from 9.2% to 10% Cervical cancer incidence to vary from 34.24/100,000 to 34/100,000

Overview. Preventive activities should be encouraged in all fields, cross-sectoral and at all healthcare levels, at population and individual level; the use of primary care, of family physicians, has a high potential for strengthening prevention. Activities of planning, assessment and monitoring should be encouraged to better manage prevention activities and programs, to improve population coverage and the assessment of individual programs, and to

13 World Bank, Romania – Healthcare Functional Review, Bucharest, 2011. 14 NICE International, Romania: Final Report, Bucharest, 2012. 15 allow for better coordinating, streamlining, encouraging and conducting prevention activities in the community.

Reconsidering the information required and strengthening IT systems will be of considerable use, not only for managing and implementing prevention programs, but also for supporting evidence-based decisions in the healthcare system.

Success factors. The main success factors are: (i) the payment system induces providers to supply more preventive services and put more emphasis on chronic-disease case management, (ii) clinical guidelines are available and disseminated for all levels and types of care, (iii) electronic patient file is fully operational, (iv) more providers in primary care are trained and qualified to carry out early detection services, (v) patients are offered incentives to seek preventive services, including early diagnosis.

Measures: The primary measures that will contribute to the achievement of the program- results are included below. The allocated budgets are indicated in Annex 1c, and the measure-related outputs and targets are indicated in Annex 3.

To Reduce the prevalence of risk factors for non-communicable diseases: Measure 1.1.1.1 Develop and implement mechanisms for prevention, diagnosis, treatment and control of cardiovascular diseases Measure 1.1.1.2 Develop and implement mechanisms for prevention, diagnosis, treatment and control of oncologic diseases Measure 1.1.1.3 Develop and implement mechanisms for prevention, diagnosis, treatment and control of diabetes mellitus Measure 1.1.1.4 Prevention and control of mental and behavior disorders Measure 1.1.1.5 Promote a healthy lifestyle and combat the main risk factors To Ensure access to early detection, diagnosis and / or treatment for specific diseases: Measure 1.1.2.1 Develop medical services for patients with special pathologies Table 2 – Measures included in Program 1.1

Program 1.2: Prevention and control of communicable diseases

1. Rationale. Although the morbidity burden in Romania, previously dominated by mother and child diseases and by communicable diseases, is at present dominated by chronic and non-communicable diseases, and the mortality caused by infectious diseases is just 1% of the total deaths, there are further aspects to be improved with respect to the monitoring and control of communicable diseases.

Additionally, the effects of climate changes require the consolidation of public health infrastructure and instruments. They impact health in a number of ways, some related to extreme weather events – natural calamities such as floods, storms, heat waves, droughts – whereas some have a more complex route, resulting, in time, in changing the patterns of infectious diseases or in new pathogens, such as emerging diseases.

In order to meet the challenges posed by continuous climate changes, the Ministry of Health includes the surveillance of events impacting public health in various ways, including climate changes. Moreover, developing a national level surveillance system is recommended, enabling the detection, assessment, notification and response to all events and risks related to public health which can represent a threat to population health. Hence, new algorithms for syndromic surveillance should be developed and implemented, with the help of electronic surveillance systems.

Objective: Program 1.2 is intended to achieve the following results by 2020: - (1.2.1) Reduce the incidence and prevalence of priority infectious diseases: Standardized TB incidence from 63/ 100,000 to 60/ 100,000 Standardized HIV incidence from 1.99/ 100,000 to 1.9/ 100,000 Standardized hepatitis B incidence from 1,11/ 100,000 to 1/ 100,000 - (1.2.2) Increase the compliance rate to the vaccinations included in the National Immunization Calendar: Vaccination coverage for children of 12 and 24 months as part of the national immunization calendar will increase from 80% to 85%

Success factors. The main success factors are: (i) sufficient financing is made available to the public health infrastructure and to interventions seeking to diagnose, treat and control infectious diseases, (ii) clinical guidelines are available and disseminated for all levels and types of care, (iii) electronic patient file is fully operational, (iv) national registry for infectious disease is developed and operational, (v) the government approves the transfer of Cantacuzino NIRDMI to the Ministry of Health, (vi) European surveillance and response network is effective, (vii) Romania is safe from pandemics or new epidemics, (viii) external or national vaccination accidents do not occur.

To Reduce the incidence and prevalence of risk factors Measure 1.2.1.1. Strengthen the system of prevention, surveillance and control of communicable diseases Measure 1.2.1.2 Strengthen the system of prevention, surveillance and control of priority communicable diseases – tuberculosis Measure 1.2.1.3 Strengthen the system of prevention, surveillance, detection, diagnosis, treatment and monitoring of priority communicable diseases – viral hepatitis Measure 1.2.1.4 Strengthen the system of prevention, surveillance, detection, diagnosis, treatment and monitoring of priority communicable diseases – HIV/ AIDS 17

To Increase the compliance rate to the vaccinations included in the National Immunization Calendar Measure 1.2.2.1 Protect the population health against main communicable diseases that can be prevented through vaccination Table 3 – Measures included in Program 1.2

Program 1.3: Improving mother and child health

Rationale. Romania’s population is decreasing and aging. The trend can be noticed across the European Union, but comparative analysis puts Romania among the countries with the biggest population decline in the last 10 years (-0.7% annually)15. This situation is the combined result of negative net migration, low fertility and high mortality.

Mother and child health, in general, and infant mortality, in particular, deserve special attention, both as a synthetic indicator of health and development and due to its significant correlation with the availability and quality of medical care.

Indicators concerning mother and child health have improved between 1995 and 2015, although child mortality in 2008 was equal to the average WHO level for the Europe Region, but twice the rate in high income countries (11 and respective 6 deaths per 1000 live births). In 2010, Romania had the highest rate of child mortality in the EU: 9.8 deaths in children aged below 1 year per 1000 live births, more than double the European rate of 4.1 deaths per 1000 live births.

Objective. Program 1.3 is intended to achieve the following results by 2020: - (1.3.1) Improve mother and child health: Infant mortality rate (0-1 years) to drop from 7.97/ 1,000 live births to 7.9/ 1,000 live births Mother birth mortality will stay at 0.1/ 1,000 live births

Overview. The public health program of the Ministry of Health regarding women and children includes a variety of interventions with the following aims: the promotion of breastfeeding; the micronutrient diet supplementation of the pregnant woman and infant baby; the early diagnosis of congenital, neonatal conditions and neuropsychological conditions in children. In addition, the social insurance system offers all children and pregnant women monitoring, diagnostic and treatment services at all levels of care, within the scope of the basic service package.

The main priority of the program concerns (i) the reduction of infant and mother mortality and (ii) newborn death risk through increased access to adequate healthcare in regional facilities for newborn children at risk and (iii) the strengthening of the newborn screening component.

Success factors. The main success factors are: (i) financing available to the program is sufficient for the scale-up of the diagnostic interventions; (ii) hospital diagnostic infrastructure is adequate; (iii) coordination of interventions between the main payers, the

15 Eurostat, population database, 2006-2015 time series, accessed in January 2017. 18

MoH and the NHIH; (iv) increased expertise and focus on prevention by family physicians; (v) pregnant women seek early-diagnosis services.

To Improve mother and child health Measure 1.3.1.1. Early detection and assessment of risks during pregnancy for both mother and child Measure 1.3.1.2 Measures of early detection and assessment of child diseases with increasing incidence, such as autism spectrum disorders Measure 1.3.1.3 Measures aimed at improving child nutrition and other measures for specific diseases Table 4 – Measures included in Program 1.3

Program 1.4: Monitoring public health in connection with the environment

Rationale. The World Health Organization and the EU Directives on health surveillance provide that Member States should meet the essential demands for surveillance and response, in order to early detect, investigate and respond to public health-related events, such as natural calamities. Various climate zones and their potential health impact should be looked into. This mechanism is based on collecting and disseminating information to the authority in charge, which can take the adequate measures and requires a consolidated coordination and a close cooperation with all stakeholders, from the healthcare sector and outside of it.

As a EU Member State, Romania is deeply involved in this international effort. The National Strategy on climate changes and low-carbon economy for 2016-2020, as well as the National Action Plan for implementing the Strategy has been promoted under the Government Decision no. 739/2016.

The Ministry of Health works together with the Ministry of Environment, Waters and Forests so as to correlate their environment surveillance activities that could negatively influence public health or the quality of the environment with monitoring population health.

The actions provided under the National Action Plan on Climate Changes 2016-2020 provide the allocation of funds, including from the state budget, for developing studies required for implementing the National Action Plan on Climate Changes 2016-2020.

Objectives. Program 1.4 is intended to achieve the following results by 2020: - (1.4.1) Reduction in diseases linked to environmental risk factors Number of occupational diseases to drop from 1025 cases to 800 cases - (1.4.2) Reduction of the negative impacts of environmental catastrophes occurring at infrastructure sites exposed to environmental risks Map of areas posing risks for human health will be developed and operational (industrial facilities, large chemical plants, routes of transportation for chemical, radioactive or hazardous materials, areas with high risk of floods of earthquakes etc.)

Overview. Activities under this program refer to conducting studies to analyze the quality of the environment and its impact on human health and designing procedures and interventions based on their findings. They will employ real time procedures for planning, managing data and setting up a database, information processing (statistical analysis, GIS techniques) and database integration, drafting graphical and cartographic materials, drafting the scenarios for the evolution of the quality of the environment in relation to identified or possible changes, forecasts, environment maps on the quality of the human environment.

Success factors. The main success factors are: (i) employees and employers are aware of the environmental risks and implement necessary preventive actions; (ii) optimal cooperation of all public agencies involved in regulating, monitoring and responding to environmental catastrophes; (iii) owners of critical infrastructure support mapping activities; (iv) responders to accidents and catastrophes have adequate capacity and resources.

Result Reduce diseases linked to environmental risk factors Measure 1.4.1.1 Monitor and report on the determining factors from the living and working environment To Reduce the negative impacts of environmental catastrophes occurring at infrastructure sites exposed to environmental risks Measure 1.4.2.1 Consolidate monitoring services for the determining factors from the living and working environment Table 5 – Measures included in Program 1.5

Strategic objective 2: Cross-cutting measures to increase the performance of the healthcare system

The health needs to be tackled by the Romanian healthcare system have changed as a result of the demographic and epidemiologic transition that occurred in the country. The burden of morbidity in Romania is currently engrossed by chronic and non-communicable diseases, which will continue to grow rapidly.

However, healthcare provision is still reliant on the old model focusing on reactive, hospital- based and episodic treatment of acute conditions and insufficient emphasis on preventive services. The primary care sector is skewed towards urban areas, offers a limited range of services and fails to provide equal access to all population groups. Long-term care and palliative care are underdeveloped and underfinanced and fail to alleviate quality of life for patients with advanced or end-stage diseases. The comparative analysis of healthcare spending between Romania and EU countries with a better track record reveals our country’s overreliance on hospital services, the high share of pharmaceuticals, low emphasis on outpatient care and prevention and the irrelevance of long-term care (see Figure 4).

100%

90% 2% 3% 3% 1% 3% 2% 3% 80% 16% 3% 2% 14% 10% 11% 29% 18% 70% 15% 28% 11% 13% 16% 60% 14% 11% 14% 6% 50% 23% 10% 25% 27% 14% 22% 24% 40% 27% 30% 46% 20% 38% 35% 34% 31% 31% 29% 10% 25%

0% Austria France Germany Romania Slovenia Spain Sweden sample average

Preventive care Long-term care (health) Pharmaceuticals and other medical non-durable goods Outpatient curative and rehabilitative care Inpatient curative and rehabilitative care

Figure 4 – The share of selected services in total current public spending in healthcare in Romania and selected EU countries (source: Eurostat)

Services are fragmented and lack coordination across care settings, due to several underlying structural characteristics such as misaligned financial incentives, weak systems for information sharing, unevenly distributed human resources and a prevailing preference

21 among patients for hospital services. Quality of care is often overlooked although Romania ranks last in patient satisfaction surveys among EU countries.

A major obstacle to better health services is outdated or inadequate infrastructure. Most hospitals do not comply with the requirements derived from current quality standards of care, while numerous primary care practices are dispersed and fail to offer comprehensive and integrated services. In many rural and isolated settings, the absence or poor state of health infrastructure proves a major deterrent for setting up new physician practices.

The National Health Strategy 2014-2020 seeks to overturn the current pyramid of services by gradually ensuring better coverage of health needs through the services currently at the base of the system, namely community care, family practices and specialized outpatient services16. To this end, the ISP strategic objective related to cross-cutting measures puts forward a multilayered approach which aims for improvements in all areas deemed essential for the access, continuity, comprehensiveness and quality of care: (i) human capital, (ii) financial resources and flows, (iii) information management, (iv) health services at all levels of care, (v) medicines and medical devices and (vi) infrastructure.

16 Government Decision no 1028/2014 on the National Health Strategy for 2014 - 2020 and the Action Plan. 22

2 Strategic objective: Cross-cutting measures to increase the performance of the healthcare system

Program 2.3: Ensure Program 2.1: Ensure the Program 2.4: patient functional framework and Program 2.2: Improve the efficiency and quality of healthcare Upgrade the access to the resources for the services healthcare system medicine healthcare system infrastructure and medical devices

Measure Measure 2.4.1.1 Measure Measure Measure 2.2.3.1 Upgrade Measure 2.3.1.1 Measure Measure 2.1.4.1 2.2.1.3 Develop service 2.2.2.1 Measure Measure Increase Measure Measure 2.1.2.1 2.1.3.1 Initiatives Measure Measure Develop Measure the long- Measure Measure provider Measure Increase 2.2.5.1 2.2.5.2 patient 2.4.1.3 2.1.1.1 Initiatives Initiatives aimed at 2.2.1.1 2.2.1.2 the 2.2.2.2 term 2.2.4.1 2.3.2.1 infrastructu 2.4.1.2 the Strengthen Ensure access to Developme Human to improve designed to promoting Develop Extend the services in Reinforcem healthcare Improve Increase re to the Developme efficiency services for demand compensat nt of the resource the improve research the role of the ent of services, the quality patient current nt of public and organ, and ed infrastructu Developme manageme informatio and community family specialty emergency rehabilitati of access to standards health performan tissue and security of medicines re for nt nt of n innovation healthcare medicine clinic and healthcare on/medical healthcare medical of infrastructu ce of human cell blood in emergency Initiatives financial manageme in the services services para-clinic services recovery, services devices healthcare re hospital transplant products financially services resources nt health outpatient home services services sustainable sector care caregiving, and the conditions palliation patients’ needs

•Territorial distribution of physicians (ratio between averages of quartile 4 and quartile 1 of county rates of physicians per 100,000 population): Baseline 2016: 2.9; Target 2020: 2.6; Target 2030: 2.2 Impacts •Territorial coverage with primary care services (No of local government units without family physician): Baseline 2016: 165; Target 2020: 130; Target 2030: 100 •Number of reimbursed hospital admissions for conditions treatable in outpatient care: Baseline 2016: 1035; Target 2020: 950; Target 2030: 900

•(2.1.1) Ensure the needed human resources in order to provide healthcare services at an agreed quality level: Coverage with available medical staff to increase from 280/100,000 physicians and 653/100,000 nurses to 287/100,000 physicians and 595/100,000 nurses •(2.1.2) Ensure sustainable funding for the healthcare sector: Total healthcare expenditures to increase from 5.1% of GDP to 5.3% of GDP •(2.1.3) Develop the Health Integrated IT System, by implementing sustainable e-health solutions: Level of development of the IPSI (Information Platform of Social Insurance) to reflect the operationalization of all its’ components (from 4 to 6) •(2.1.4) Develop the research and innovation capacity in the health sector: Applications resulting from research projects transferred into medical practice (no) to increase from 0 to 5 •(2.2.1) Increase the provision of preventive services for the population through family healthcare: % of local government units (LGU) where there is at least one family doctor for every 2000 inhabitants will increase from 50% to 53%; number of towns without specialist outpatient care providers will drop from 57 to 0 •(2.2.2) Rationalize and increase efficiency for hospital healthcare services: Number of acute care beds will decrease from 4.2 per 1,000 inhabitants to 4 per 1,000 inhabitants; Admission rate for acute cases will decrease from 19 cases Programs' per 1,000 inhabitants to 18 cases per 1,000 inhabitants outcomes •(2.2.3) Develop the palliative assistance to be provided to terminal patients and for long-term recovery: Beds for long term care will increase from 5 per 1.000 inhabitants at least 65 years old to 6 per 1,000 inhabitants at least 65 years old; Beds for palliative care will increase from 18 per 100,000 inhabitants to 20 per 100.000 inhabitants •(2.2.4) Increase the quality of healthcare services, irrespective of the level where they are supplied: Legal framework allowing the integration and/ or coordination of services providers will be approved and applicable •(2.2.5) Improve the outcomes of blood transfusions and organ transplant services: Number of transplants per %0000 inhabitants to increase from 65 to 68; The quantity of transfused blood and plasma to remain at 180000 liters •(2.3.1) Increase the number of patients that have access to medicines needed to control or treat chronic conditions: Updates to the reimbursed medicines list will remain at least 3 per year •(2.3.2) Reduce waiting lists for medical devices: Medical devices registry will be developed and operational •(2.4.1) Decrease the inequity as regards access to healthcare services through the development of infrastructure: Population covered by newly-built regional hospitals (as % and number of regions) to increase from 0 to 39% and 3 regions, respectively; Density of operational radio-therapy equipment compliant with EU standards, per types of equipment will increase from 0.36 units/ 100,000 to 0.45 units/ 100,000

Box 3 – Strategic objective 2: impact and outcome indicators

Strategic objective 2: Cross-cutting measures to increase the 2017 2018 2019 2020 performance of the HC system Program 2.1: Ensure the functional framework and the resources for the 15.000 252.750 261.150 107.600 healthcare system Program 2.2: Improve the efficiency 18.283.225 19.121.517 21.493.437 23.311.519 and quality of healthcare services Program 2.3: Ensure patient access 3.282.641 3.446.773 3.619.112 3.800.068 to medicine and medical devices Program 2.4: Upgrade the 261.794 473.191 1.014.537 1.366.555 healthcare system infrastructure Table 6 – Strategic objective 2: Breakdown of financing by budgetary program (thousand RON)

Program 2.1: Ensure the functional framework and resources for the healthcare system Rationale: For the past years between 1,000 and 1,500 physicians have been migrating annually to other countries in search of better working conditions, better pay or professional recognition. As a result, the total number of medical staff has been increasing slowly; in public hospitals the dynamic was even slower than the national average17. The territorial distribution of the medical staff is unbalanced. In the six counties with medical university, the number of physicians amounts to 49% of the national total, while the other half is distributed among the remaining 36 counties. Furthermore, the ratio between the averages of quartile 4 and quartile 1 of county rates of physicians per 100,000 population stands at 2.9, while the ratio between deciles 10 and 1 reaches 5.2. The differences remain high between predominantly urban and rural counties: the ratio between the averages of physicians per 100,000 population is 1.9. All data points to an uneven distribution of staff resources at county level with the population of poorer and predominantly rural facing inadequate access to providers of care.

In recent years the digitization of medical services increased, even at the hospital level, but the level is still suboptimal on several pillars, whereas the management of the national health programs requires the development and/ or consolidation of disease registries. In short, the system`s capacity to collect, process, analyze and report the data in the existing IT or information systems, as well as reflecting the information and data in public policies are faulty, whereas the component related to the communication with/ access to relevant information for patients and the population is not well adequately developed. The ITC can play a significant part in increasing competitiveness in the health sector, including in terms of its efficient and effective e-government. A single integrated information system on public health with an integrated architecture, using interoperable IT applications, would allow generation of quality information and its efficient use for drafting health policies and ensuring more effective system management.

According to the World Bank18, in Romania the total healthcare expenditures are a little over 5% of the GDP, compared to the European average19 of 6.5% and an EU average of 8.7%.

17 NPHI data reveal that the number of public hospital physicians increased by 1.6% from 2014 to 2015, mostly with resident physicians. The six counties with medical schools accounted for almost 60% of the growth. 18 World Bank, Functional Review of the Health Sector in Romania, Final Report, April 2011. 19 WHO Europe region. 26

The difference arises, on the one hand, from the fairly low public expenditure on health and also from the small share of private expenditure for health, compared to other countries20, lack of tax incentives as well as the financial crises, which contributed to a halt in the private insurances market. The health sector needs a long-term strategy, in order to ensure its sustainable funding. In the strategic directions proposed it is necessary to pair an action plan designed to increase efficiency of the health sector, with the introduction of better cost control measures, with a sustainable increase in public funding and defining a regulatory framework that stimulates private funding in the health sector, including the development of voluntary health insurance.

Objectives: Program 2.1 is intended to achieve the following results by 2020: - (2.1.1) Ensure the needed human resources to provide healthcare services at an agreed quality level • Coverage with available medical staff to increase from 280/100,000 physicians and 653/100,000 nurses to 287/100,000 physicians and 595/100,000 nurses

- (2.1.2) Ensure sustainable funding for the healthcare sector Total healthcare expenditures to increase from 5.1% of GDP to 5.3% of GDP - (2.1.3) Develop the Health Integrated IT System, by implementing sustainable e- health solutions Level of development of the IPSI (Information Platform of Social Insurance) to reflect the operationalization of all its’ components (from 4 to 6) - (2.1.4) Develop the research and innovation capacity in the health sector Applications resulting from research projects transferred into medical practice (no) to increase from 0 to 5

Overview. The sustainability of the human resources from the healthcare sector will be ensured through retention policies that aim at granting financial incentives and improving the professional evolution perspectives of the medical staff. Simultaneously, it is necessary to give incentives to those practicing medicine in disadvantaged areas or in specialties where there is a deficit, whereas the staff training capacities will have to be adjusted to the health sector`s need for specialists.

The Program aims at developing the strategic and regulatory framework to optimize human resources in the health sector, both in the fields of clinical services and in that of public health. At the same time, the Program also aims at reviewing the funding and reimbursement system for healthcare services, a rigorous control of public expenditures incurred with healthcare services and defining more clearly the healthcare services package covered from NHIF.

Moreover, it is envisaged to develop an efficient vertical and horizontal information system that integrates all the components of the healthcare system (including HR, financial management, etc.). The information system will be supported by integrated IT platforms that do away with redundancies and ensure access to valid data and information. This Program also focuses on developing the research, development and innovation capacity in the health sector and developing research in public health and healthcare services, in view of preparing evidence-based policies.

20 18% in Romania, compared to 41% in Bulgaria and 28% in Poland. 27

Success factors. The main success factors are: (i) the government puts more financial resources into healthcare to implement staff retention policies; (ii) local governments contribute to the MoH and NHIH initiatives to encourage physicians and nurses to medically underserved areas; (iii) EU-funded operational programs dedicate sufficient resources to all planned IT projects in healthcare; (iv) NHIH IT systems are adapted to pay-for-performance reimbursement; (v) medical schools and research institutes put forward solid research projects to be financed from national or/ and EU funds.

To Ensure the needed human resources in order to provide the healthcare services at an agreed quality level Measure 2.1.1.1 Human resource development initiatives To Ensure sustainable funding for the healthcare sector Measure 2.1.2.1 Initiatives to improve the management of financial resources To Develop the Health Integrated IT System, by implementing sustainable e-health solutions Measure 2.1.3.1 Initiatives designed to improve information management To Develop the research and innovation capacity in the health sector Measure 2.1.4.1 Initiatives aimed at promoting research and innovation in the health sector Table 7 – Measures included in Program 2.1

Program 2.2: Improve the efficiency and quality of healthcare services Rationale. Healthcare services are one of the three strategic areas of the National Health Strategy for 2014-2020 and make the biggest part of healthcare spending in Romania. Every year they are allocated more than 50% of the combined budgets of the NHIF and the MoH. In 2015, the value of budget appropriations exceeded RON 14 billion21, which amounted to 2% of the GDP.

NHS 2014-2020 underlines a series of structural weaknesses of healthcare services: (i) the poor development of primary healthcare22 and rehabilitation, recovery, long-term caregiving services; (ii) the incomplete coverage at the territorial level of primary care; (iii) the flawed management of chronic conditions, which focuses on patient interaction during acute episodes, but less so on the mitigation of risk factors, early diagnosis and continuous monitoring; (iv) the lack of comprehensive guidelines for all levels of care, poor coordination of care between providers, lack of clinical pathways and, therefore, (v) inefficient use of services.

21 Data processed from the budget implementations of SNFSHI and MoH, available on the website www.mfinante.ro. 22 NHIH data reveals that curative services are the vast majority of services provided by family doctors: in 2015 they supplied 50 million curative healthcare services, but only a little over 2 million preventive and prophylactic medical services. 28

In this context, the efficiency of healthcare services expenditures is low, because a disproportionate portion of resources is absorbed by hospitals, despite the fact that in many cases patients admitted to the hospital could have been more inexpensively prevented or treated in primary care.

Against this background, the goals laid down in the Strategy for the field of healthcare services are as follows:  Decentralization and regionalization of care;  Development of universally accessible primary care with emphasis on prevention and health promotion;  Integration of care and setup of care networks;  Restructuring of hospital services.

Objectives: Program 2.2 is meant to achieve the following results by 2020: - (2.2.1) Increase the provision of preventive services for the population through family healthcare: % of local government units (LGU) where there is at least one family doctor for every 2000 inhabitants will increase from 50% to 53% Number of towns without specialist outpatient care providers will drop from 57 to 0 - (2.2.2) Rationalize and increase efficiency for hospital healthcare services: Number of acute care beds will decrease from 4.2 per 1,000 inhabitants to 4 per 1,000 inhabitants Admission rate for acute cases will decrease from 19 cases per 1,000 inhabitants to 18 cases per 1,000 inhabitants - (2.2.3) Develop the palliative assistance to be provided to terminal patients and for long-term recovery: Beds for long term care will increase from 5 per 1,000 inhabitants at least 65 years old to 6 per 1,000 inhabitants at least 65 years old Beds for palliative care will increase from 18 per 100,000 inhabitants to 20 per 100,000 inhabitants - (2.2.4) Increase the quality of healthcare services, irrespective of the level where they are supplied: Legal framework allowing the integration and/ or coordination of services providers approved and applicable - (2.2.5) Improve the outcomes of blood transfusions and organ transplant services: Number of transplants per %0000 inhabitants to increase from 65 to 68 The quantity of transfused blood and plasma to remain at 180,000 liters

Overview. The budget program “Improving the efficiency and quality of healthcare services” is aimed at (i) increasing public access to healthcare services, by developing the outpatient component of the system and long-term caregiving, (ii) improving the efficiency of public fund use, by revising the payment systems and carrying on the reorganization of hospital sector and (iii) improving the quality of healthcare services, by fostering healthcare based on evidence, integrating the suppliers involved in the therapeutic pathways, extending the accrediting system for suppliers and reinforcing communication with patients.

In preparing the budget of the program, consideration was given to all services provided at the above-mentioned levels of care, irrespective of their financing sources, NHIF or the budget of MoH, including services supplied as part of national public healthcare programs or national curative programs. This program did not include, for each healthcare branch,

29 medical services for patients suffering from disorders which fall under the scope of other budget programs in the strategic objective “Improving the health of the population through measures of morbidity prevention and control”, more specifically communicable diseases, cardiovascular diseases, oncologic diseases, diabetes, rare diseases or mental and behavioral disorders.

Success factors. The main success factors are: (i) development and implementation of regional and county health service plans; (ii) financing mechanisms offer providers incentives to extend preventive services, advance chronic disease management and improve quality of care; (iii) electronic patient file is fully operational; (iv) local governments provide support to the MoH for the development of community care; (v) local governments get involved on initiatives to attract and/ or retain medical staff and to health improve infrastructure; (vi) staff numbers are sufficient to ensure implementation of quality standards and clinical guidelines requirements; (vii) health personnel is trained on clinical guidelines, care coordination, clinical pathway enforcement.

To Increase the provision of preventive services for the population through primary care Measure 2.2.1.1 Develop the community healthcare services Measure 2.2.1.2 Extend the role of family medicine services Measure 2.2.1.3 Develop the services in the specialty clinic and para-clinic outpatient care To Rationalize and increase efficiency of hospital services Measure 2.2.2.1 Increase the efficiency and performance of hospital services Measure 2.2.2.2 Reinforcement of emergency healthcare services To Develop the palliative assistance provided to terminal patients and for long-term recovery Measure 2.2.3.1 Develop the long-term healthcare services, rehabilitation/medical recovery, home caregiving, palliation To Increase the quality of healthcare services, irrespective of the level where they are supplied Measure 2.2.4.1 Improve the quality of healthcare services To Improve the outcomes of blood transfusions and organ transplant services Measure 2.2.5.1 Strengthen services for organ, tissue and human cell transplant Measure 2.2.5.2 Ensure demand and security of blood products Table 8 – Measures included in Program 2.2

Program 2.3: Ensure patient access to medicine and medical devices Rationale. The National Health Strategy 2014-2020 sets as strategic objective “developing and implementing an evidence-based medicine policy, granting fair and sustainable access to medicine for the population”. The lines of action listed include reviewing the list of compensated medicines, based on cost-effectiveness criteria; implementing the medical 30 technologies assessment system and developing the necessary capacities at central level; introducing cost-volume mechanisms for new medicine with high costs or for which an increase in usage is envisaged; biannual revision of the medicine prices and monitoring the doctors` medicine prescription behavior23.

Compensated medicines and medical devices represent about 35% of the total expenditures of the National Health Insurance Fund (NHIF), respectively 34% for medicines with and without personal contribution or medicines provided from the national curative health programs and 1% for medical devices24. On top of this, there is also the value of medicines covered from (i) the MoH budget, through public health national programs, the funding programs for emergency units and priority actions, as well as (ii) those indirectly funded through NHIF for continuous and day hospitalization and for dialysis patients. All in all, the consumption of medicines covered by the NHIF or from the MoH budget, in 2015, amounted to RON 8.18 billion, that is 1.15% GDP25.

As for the volume and the beneficiaries of the compensated medicines and medical devices, the numbers confirm the importance of this budgetary program. In 2015, 52.1 million prescriptions for compensated medicines were issued and 50.7 million prescriptions were released through the open circuit pharmacies, a 4% increase against the previous year26. As for the medical devices, according to the NHIF data in 2015 the number of insured beneficiaries for which the request for medical devices was approved amounted to 266,000. At the end of the year, the waiting lists for medical devices included 16,000 requests, 30% less than at the end of 201427.

As for patients access to new medicines, 46 new International Nonproprietary Names have been included in the list of reimbursed medicines since 2014. Of these, 40 are unconditionally reimbursed, whereas 6 medicines are the subject of 5 managed entry agreements implemented between 2015-2016. For other INNs there is a conditioned reimbursement decision from the National Agency for Medicines and Medical Devices; market authorization holders are awaiting the negotiation of managed entry agreements.

Objectives: Program 2.3 is meant to achieve the following results by 2020: - (2.3.1) Increase the number of patients that have access to medicines needed to control or treat chronic conditions: Updates to the reimbursed medicines list will at least 3 times per year - (2.3.2) Reduce waiting lists for medical devices: Medical devices registry will be developed and operational

Overview. The Program refers to patient access to reimbursed medicines and to medical devices. The medicines included are those funded from the NHIF or the MoH budget, respectively medicines with or without personal contribution, as well as medicines included in the national health programs. The Program does not include the compensated medicines for patients suffering from conditions covered by the budget programs falling under the

23 National Healthcare Strategy 2014-2020, p. 64, Government Decision no 1028/2014. 24 According to the FNUASS execution data, available on http://www.NHIF.ro/page/bugetul-fnuass.html. 25 According to quarterly reports on consumption of medicines covered by FNUASS- MoH, available at http://www.NHIF.ro/page/consum-medicamente.html. 26 The 2015 NHIF Activity Report 27 The NHIF Reports on medical healthcare for 2014 and 2015, available on http://www.NHIF.ro/category/rapoarte-i-situatii.html 31 strategic objective “Improving the health of the population through measures of morbidity prevention and control”, as well as those administered during the procedures performed in the emergency units, the intensive therapy wards, continuous and day hospitalization and dialysis centers.

As for medical devices, the program includes elements from the basic package for medical devices for the recovery of organic or functional deficiencies in the out-patient care, as well as those from the national health programs.

Success factors. The main success factors are: (i) the financing of reimbursed medicines is predictable and sufficient to cover expenditure needs; (ii) the clawback tax mechanism remains in force; (iii) prescription guidelines are available and disseminated for all levels and types of care; (iv) electronic patient file is fully operational; (v) patient registries are operational for the costliest or most frequent chronic diseases.

To Increase the number of patients who have access to medicines needed to control or treat chronic conditions Measure 2.3.1.1 Increase patient access to compensated medicines in financially sustainable conditions To Reduce waiting lists for medical devices Measure 2.3.2.1 Increase patient access to medical devices Table 9 – Measures included in Program 2.3

Program 2.4: Upgrade the healthcare system infrastructure

Rationale. The healthcare system relies on an infrastructure that was designed 50 to 60 years ago, when the need for healthcare services and medical technologies was very different from nowadays. Although certain hospitals have been upgraded and emergency services have been improved, the distortions in the services supply structure have not been removed. In many cases adapting old infrastructure to current challenges and requirements is costlier than building anew. Access to high technology is limited; a comparative analysis based on Eurostat data reveals that Romania is placed at the bottom of the chart in terms of patient access to CT scanning, MRI scanning, PET-CT scanning, angiography and mammography28.

NHS 2014-2020 views health infrastructure development as a priority objective and sets actions and targets for investment in public health, primary care, hospitals and emergency services infrastructure.

Objectives. Program 2.4 is meant to achieve the following results by 2020: - (2.4.1) Decrease the inequity about access to healthcare services through the development of infrastructure:

28 Eurostat, healthcare resources database, accessed in December 2016. The numbers of countries in the samples were 22, 21, 17, 15 and 18 respectively. 32

Population covered by newly-built regional hospitals (as % and regions number) to increase from 0 to 39% and 3 regions, respectively Density of operational radio-therapy equipment compliant with EU standards, per types of equipment will increase from 0.36 units/ 100,000 to 0.45 units/ 100,000

Overview. The Ministry of Health has identified hospital healthcare units which form part of the strategic network and where the required infrastructure investments are to be channeled, in accordance with its vision referring to the development and priorities in financing healthcare sector investments between 2014 and 2020 to contribute to the achievement of the performance goal proposed for this level of services. The type of anticipated measures for certain types of hospitals depends on their positioning in the hierarchy of healthcare units with beds in Romania (at the national, regional, county and local level). Regional and county service plans are under development, containing provisions referring to the rationalization of physical (buildings) and medical (medical equipment) infrastructure.

Success factors. The main success factors are: (i) development and implementation of regional and county health service plans and maps; (ii) development and approval of the multiannual investment plan for public hospitals; (iii) standardization of hospital equipment requirements based on competency level; (iv) ensuring sufficient funding from EU and other external sources.

To Decrease the inequity of access to healthcare services through the development of infrastructure Measure 2.4.1.1 Adjustment of hospital network to the current standards of healthcare services and the patients’ needs Measure 2.4.1.2 Development of public health infrastructure Measure 2.4.1.3 Development of the infrastructure for emergency services Table 10 – Measures included in Program 2.4

Strategic objective 3: Develop the institutional capacity of management structures in the healthcare system

The MoH, NHIH and NAHQM are the most relevant public stakeholders for improving the health condition of Romanians and for achieving health convergence with the European Union. All three institutions set forth legislative enactments, public policies and strategies for the allocation of health funds. In this context, they aim at developing high institutional capacity standards including for the subordinated and deconcentrated units.

Over the life-cycle of the ISP, the priorities related to institutional capacity development aim at (i) improving the personnel skills; (ii) the optimization of strategy and policy-making processes; (iii) evidence generation for public policies; (iv) increasing the efficiency of information and counselling for patients, providers and other stakeholder organizations; (v) efficient and effective use of domestic and international financial resources.

3 Strategic objective: Develop the institutional capacity of management structures in the healthcare system

Program 3.1: Improve the performance of institutions with strategic, regulatory, administration, representation role in the healthcare system

Measure 3.1.1.2 Measure 3.1.3.1 Measure 3.1.1.3 Measure 3.1.1.1 Develop the Develop the human Measure 3.1.3.2 Increase institutional Measure 3.1.2.1 Measure 3.1.2.2 Develop integrity, administrative capital from the MoH, Ensure the optimum performance by Promote healthcare Promote evidence- transparency and capacity of NHIF and other functioning of public improving the in all policies based public policies professional ethics centralized public subordinated/coordin institutions management systems procurement ated institutions

•Percentage of Romanians content who trust the healthcare Impacts system: Baseline 2016: 27%; Target 2020: 30%; Target 2030: 40%

•(3.1.1) Implement and use best practice tools in the healthcare administration: Number of best practice tools used in the healthcare administration to increase from 2 to 4 •(3.1.2) Increase efficiency of the public policy formulation and implementation processes in the healthcare sector: Percentage of Programs' draft pieces of legislation with impact studies to increase from outcomes 10% to 15% •(3.1.3) Increase productivity of the human capital in the healthcare administration: Percentage of management personnel who has to meet annual performance targets to increase from 0 to 15%

Box 4 – Strategic objective 3: impact and outcome indicators

Strategic objective 3: Develop the institutional capacity of management 2017 2018 2019 2020 structures in the healthcare system

Program 3.1: Improve the performance of institutions with strategic, regulatory, 4.356.016 6.014.291 6.419.925 6.351.975 administration, representation role in the healthcare system

Table 11 – Strategic objective 3: Breakdown of financing by budgetary program (thousand RON)

Program 3.1: Improve the performance of strategic, regulatory and administration institutions in the healthcare system

Rationale. The internal environment analysis revealed an administrative incapacity of healthcare institutions with a strategic, regulatory, administration and representation role. In order to successfully manage such a complex sector, several tasks have to be performed in an integrated, coherent and sustainable manner. Human resources and good practice tools are the corner stones of this process of efficiently and effectively managing the healthcare sector. For several reasons, this resource is significantly undersized, both from a qualitative and a quantitative perspective. Failures of past reforms and the incapacity to formulate evidence- based sectoral public policies are the direct outcome of these systemic deficiencies, which have been underlined before by the Government, the World Bank and the European Union.

Objectives: Program 3.1 is meant to achieve the following results by 2020: - (3.1.1) Implement and use best practice tools in the healthcare administration: Number of best practice tools used in the healthcare administration to increase from 2 to 4 - (3.1.2) Increase efficiency of the public policy formulation and implementation processes in the healthcare sector: Percentage of draft pieces of legislation with impact studies to increase from 10% to 15% - (3.1.3) Increase productivity of the human capital in the healthcare administration: Percentage of management personnel who has to meet annual performance targets to increase from 0 to 15%

Overview. The institutional modernization of the MoH, NHIH and the subordinated institutions focuses on several fields. Firstly, implement and use best practice tools in the healthcare administration. Secondly, increase efficiency of the public policy formulation and implementation processes in the healthcare sector. Thirdly, develop the human capital, by introducing modern HR management tools, by conducting needs assessment of the human capital in the MoH and NHIF, as well as in the subordinated/coordinated entities, by improving staff recruitment and motivational factors, introducing performance-based incentives, developing the organizational culture and staff skills.

Success factors. The main success factors are: (i) civil servants’ annual appraisal puts more emphasis on performance targets; (ii) reform of the public policy cycle at Government level is continued; (iii) budgeting process is reformed so as to rely of program budgeting.

To Implement and use best practice tools in the healthcare administration Measure 3.1.1.1 Develop integrity, transparency and professional ethics Measure 3.1.1.2 Develop the administrative capacity of centralized public procurement Measure 3.1.1.3 Increase institutional performance by improving the management systems To Increase efficiency of the public policy formulation and implementation processes in the healthcare sector Measure 3.1.2.1 Promote healthcare in all policies Measure 3.1.2.2 Promote evidence-based public policies To Increase productivity of the human capital in the healthcare administration Measure 3.1.3.1 Develop the human capital from the MoH, NHIF and other subordinated/coordinated institutions Measure 3.1.3.2 Ensure the optimum functioning of public institutions Table 12 – Measures included in Program 3.1

4. Arrangements for implementation, monitoring and evaluation of the ISP To be relevant, an institutional strategic plan must link to the government’s core policy and financial planning processes. Accordingly, the healthcare ISP 2017-20 must guide the preparation of this year’s budget request, which will be prepared in 2016 for 2017-20. It is noted that, although the budget contains expenditure projections for three years, it only provides activity and expenditure details for one year. However, over time, it is anticipated that greater attention would be paid to the second and third years. Accountability: With the parliamentary approval of the State Budget, the implementation of the strategic plan begins. The ISP working group, through MoH Public Policy Unit and with the help of technical units, will prepare annual operational plans for the implementation of the ISP. They will serve as a basis for monitoring. This activity is extremely important as it enables senior management to identify and resolve potential challenges in advance. Monitoring and evaluation framework: A monitoring and evaluation framework is laid out in Annexes 2 and 3, and provides indicators and targets for the various planning levels (see Table below). Annex 1 provides an overview of the financial inputs. Data collection and management: An IT system for strategic planning and performance assessment has been developed with the format of the proposed structure of ISP. The application will illustrate key functions of ISP. The IT application is connected with GSG and MPF and the progress of ISP implementation is seen at all levels of execution and management. The progress against indicators is seen by all interested stakeholders and citizens, through an interface available for the public at large. Reporting: in deciding what to monitor and with what frequency, it is important not to overburden operational departments. Typically, different levels of performance indicators require different reporting time frames. Thus: Input and process/product indicators will be measured monthly, or at least quarterly Output indicators will be measured quarterly, Outcome indicators will be measured semi-annually Impact indicators will be tracked annually. A diagram of the monitoring cycle of for the healthcare ISP is provided below.

ANNUAL SEMI-ANNUAL RESULTS RESULTS REVIEW: REVIEW: OUTPUT, PRODUCT ALL AND INPUT INDICATORS INDICATORS

JAN. APRIL JUL OCT. Y

QUARTERLY QUARTERLY QUARTERLY QUARTERLY REVIEW: PROCESS/ REVIEW: PROCESS/ REVIEW: PROCESS/ REVIEW: PROCESS/ PRODUCT AND INPUT PRODUCT AND INPUT PRODUCT AND INPUT PRODUCT AND INPUT INDICATORS INDICATORS INDICATORS INDICATORS

Figure 5 – Monitoring Cycle for the Healthcare ISP It is important to report to the Government, Parliament, stakeholders and general public on the progress being made towards the planned results, as per performance indicators and targets established. Although annual progress reports are not currently prepared, it will be critical that annual reports be produced and publicly released by MOH in the future. Evaluation: MOH and its partners have not yet developed a formal approach to ex-post evaluation of its other programs and policies. In the future, this activity will provide important information for implementing changes to the way in which programs and policies are delivered. These changes will not affect dramatically the strategic plan. It will be desirable to strengthen the periodic evaluation of the entire program portfolio outlined in the ISP. Updating the ISP: A full strategic planning exercise will be conducted every four years. During the intervening years, MOH and its partners, through the ISP working group, will prepare an annual update to determine if any changes to the strategic plan are required. The update will require the completion of three activities:  comparing the previous year’s actual versus planned results; these would be based on targets set in the strategic and operational plans;  conducting an environmental scan to determine if any significant changes are required to the assumptions that underpin the current plan (see Chapter Context and Challenges); and  adding one additional year to the plan.

By ensuring that the plan continues to cover at least three years beyond the planning year, the updated strategic plan can continue to inform the annual budget request, which also requires a three-year forecast. Most often, the vision, strategic goals and program goals do not change unless a major event, such as an unforeseen economic crisis, occurs. The updating exercise should be completed by May 30 each year, which allows time for the collection and analysis of results achieved from the previous year.

5. Financial resources The ISP for the healthcare sector is made of three strategic objectives comprising nine budgetary programs. The measures, actions and activities included in the plan are assigned to multiple stakeholders, the most important of which are the MoH, the NHIH and their deconcentrated services, the NAHQM, the NIPH, the NADMD and the NSPHMTH. As a result, the ISP budget is made of the resources spent by two main credit officers – MoH and NHIH – and the subordinates.

The allocations forecast for ISP until 2020 are separated by source between the state budget, including the National Health Insurance Fund, non-reimbursable funds (from the European Union, Norwegian and European Economic Area financial mechanisms, Swiss-Romanian Cooperation Program etc.) and loans. The spending limits of the NHIF and MoH state budget components were taken from the Fiscal-Budgetary Strategy 2017-2019 (FBS)29. As such, the validity of the budgetary programs depends on the fulfilment of the underlying assumptions of the Strategy. The FBS also offers indicative limits for most of the non-reimbursable funding available to the MoH throughout 2014-2020 programming period.

Over the four-year life-cycle, the ISP strategic objectives and budgetary programs will add up to 160 bn. RON, with annual allocations rising from 34 bn. RON in 2017 to 45 bn. RON by 2020 (see Figure 6). The breakdown by strategic objective reveals almost two-thirds of the funding being channeled through SO 2 “Cross-cutting measures”, where most of the health services and medicines are included. SO 1 “Improving the health of the population” which plans interventions against the major determinants of the health status accounts for 23% of the ISP. The remaining 14% is allocated through SO 3 “Institutional capacity” for recurrent spending and capacity development projects.

42.54 44.98

50 45 38.06 45

34.17 40 Billions 40 10.04 Billions 9.74 35 35 8.75 30 30 7.97 25 25 20 20 26.39 28.59 23.29 15 21.84 15 10 10 5 5 4.36 6.01 6.42 6.35 - 0 2017 2018 2019 2020

1 Strategic objective: Improving the health of the population through measures of morbidity prevention and control

2 Strategic objective: Cross-cutting measures to increase the performance of the healthcare system

3 Strategic objective: Develop the institutional capacity of management structures in the healthcare system

Total ISP

Figure 6 – Annual ISP financing by strategic objective (bn. RON)

The main spending channel of the ISP is the National Health Insurance House, which will manage more than 80% of available funding (see Figure 7). This comes as no surprise, as NHIH is the single payer in the social health insurance system and the biggest payer in the

29 Available of the MoF website at http://www.mfinante.gov.ro/strategbug2015.html?pagina=domenii. 41 overall healthcare sector. The MoH and its subordinated institutions will spend 17% of the ISP resources, mostly on public health interventions, emergency transport and care,

expensive hospital procedures and infrastructure.

50 44.98 45 42.54

45 0.02 40 Billions 38.06 0.02 Billions 40 7.67 34.17 0.01 7.66 35 35 0.01 6.67 30 5.34 30 25 25 20 20 37.29 34.86 15 15 28.82 31.38 10 10 5 5 - 0 2017 2018 2019 2020

NHIH MoH NAHQM Total ISP

Figure 7 – Annual ISP financing by main credit officer (bn. RON)

The breakdown of the ISP by financing source reveals the overreliance on state budget funding, which accounts for 98% of total. The vast majority of state budget funding is directed towards recurrent health services via NHIF or the MoH budget. The remainder of the ISP is made of investment projects financed from non-reimbursable funds or loans.

50 44.98 45 42.54 45 0.690.10 40

38.06 0.14 Billions 0.84 Billions 40 34.17 0.500.08 35 35 0.020.00 30 30 25 25 20 41.57 44.19 20 37.48 34.15 15 15 10 10 5 5 - 0 2017 2018 2019 2020 cofinancing of non-reimbursable funds (EU et al.) non-reimbursable funds (EU et al.)

state budget Total ISP

Figure 8 – Annual ISP financing by source of funding (bn. RON)

As far as the budget management is concerned, a major institutional challenge is the stakeholders’ ability to implement the ISP, namely planning, executing and monitoring their budgets on defined programs. From an organizational and managerial perspective, the transition and monitoring of more budgetary programs represents the main challenge throughout the ISP lifecycle. Budget management by programs will also bring important changes in the budget departments of MoH and NHIH.

Annex 1a: Budgetary Programs and Financial Resources by financing source 2017-2020 (thousand RON)

cofinanci cofinanci cofinanci cofinanci non- non- non- non- ng of ng of ng of ng of reimburs reimburs reimburs reimburs non- non- non- non- state state state state total ISP total ISP total ISP total ISP total ISP able able able able reimburs reimburs reimburs reimburs budget budget budget budget funds (EU funds (EU funds (EU funds (EU able able able able et al.) et al.) et al.) et al.) funds (EU funds (EU funds (EU funds (EU et al.) et al.) et al.) et al.) Strategic objective/ Budgetary 2017-2020 2017 2018 2019 2020 2017 2018 2019 2020 2017 2018 2019 2020 2017 2018 2019 2020 program 1 Strategic objective: Improving the health of the population through 36.499.777 7.972.509 8.749.113 9.735.413 10.042.742 7.970.209 8.544.213 9.497.263 9.871.392 2.000 176.400 203.000 149.000 300 28.500 35.150 22.350 measures of morbidity prevention and control Program 1.1: Prevention and control of non-communicable 26.623.080 6.087.871 6.553.819 6.839.249 7.142.141 6.087.871 6.438.819 6.724.249 7.027.141 - 100.000 100.000 100.000 - 15.000 15.000 15.000 diseases Program 1.2: Prevention and 9.643.546 1.850.795 2.134.166 2.799.135 2.859.451 1.848.495 2.069.766 2.734.735 2.803.101 2.000 56.000 56.000 49.000 300 8.400 8.400 7.350 control of communicable diseases Program 1.3: Improving mother and 140.369 32.006 33.606 36.055 38.703 32.006 33.606 36.055 38.703 ------child health Program 1.4: Monitoring public health in connection with the 92.781 1.838 27.522 60.974 2.447 1.838 2.022 2.224 2.447 - 20.400 47.000 - - 5.100 11.750 - environment 2 Strategic objective: Cross-cutting measures to increase the 100.110.868 21.842.660 23.294.231 26.388.235 28.585.742 21.827.660 22.934.656 25.669.435 27.968.517 12.500 309.000 621.000 535.500 2.500 50.575 97.800 81.725 performance of the healthcare system Program 2.1: Ensure the functional framework and the resources for 636.500 15.000 252.750 261.150 107.600 - - - - 12.500 216.500 223.500 93.000 2.500 36.250 37.650 14.600 the healthcare system Program 2.2: Improve the efficiency 82.209.698 18.283.225 19.121.517 21.493.437 23.311.519 18.283.225 19.095.192 21.461.287 23.284.894 - 22.500 27.500 22.500 - 3.825 4.650 4.125 and quality of healthcare services Program 2.3: Ensure patient access 14.148.594 3.282.641 3.446.773 3.619.112 3.800.068 3.282.641 3.446.773 3.619.112 3.800.068 ------to medicine and medical devices Program 2.4: Upgrade the 3.116.076 261.794 473.191 1.014.537 1.366.555 261.794 392.691 589.037 883.555 - 70.000 370.000 420.000 - 10.500 55.500 63.000 healthcare system infrastructure 3 Strategic objective: Develop the institutional capacity of 23.142.208 4.356.016 6.014.291 6.419.925 6.351.975 4.352.048 5.998.807 6.400.245 6.348.975 3.420 12.960 16.400 2.500 548 2.524 3.280 500 management structures in the healthcare system Program 3.1: Improve the performance of strategic, regulatory and administration 23.142.208 4.356.016 6.014.291 6.419.925 6.351.975 4.352.048 5.998.807 6.400.245 6.348.975 3.420 12.960 16.400 2.500 548 2.524 3.280 500 institutions in the healthcare system Total ISP 159.752.852 34.171.186 38.057.635 42.543.574 44.980.458 34.149.918 37.477.676 41.566.944 44.188.883 17.920 498.360 840.400 687.000 3.348 81.599 136.230 104.575

Annex 1b: Budgetary Programs and Financial Resources by main credit officer 2017-2020 (thousand RON)

total ISP total ISP total ISP total ISP total ISP MoH MoH MoH MoH NHIH NHIH NHIH NHIH NAHQM NAHQM NAHQM NAHQM

Strategic objective/ 2017- 2017 2018 2019 2020 2017 2018 2019 2020 2017 2018 2019 2020 2017 2018 2019 2020 Budgetary program 2020 1 Strategic objective: Improving the health of the population 36.499.777 7.972.509 8.749.113 9.735.413 10.042.742 643.645 1.058.602 1.137.864 1.119.240 7.328.864 7.690.510 8.597.549 8.923.502 - - - - through measures of morbidity prevention and control Program 1.1: Prevention and control of non-communicable 26.623.080 6.087.871 6.553.819 6.839.249 7.142.141 49.854 168.199 171.835 175.281 6.038.017 6.385.621 6.667.414 6.966.861 - - - - diseases Program 1.2: Prevention and control of communicable 9.643.546 1.850.795 2.134.166 2.799.135 2.859.451 559.947 829.276 869.001 902.810 1.290.848 1.304.890 1.930.134 1.956.641 - - - - diseases Program 1.3: Improving mother 140.369 32.006 33.606 36.055 38.703 32.006 33.606 36.055 38.703 ------and child health Program 1.4: Monitoring public health in connection with the 92.781 1.838 27.522 60.974 2.447 1.838 27.522 60.974 2.447 ------environment 2 Strategic objective: Cross- cutting measures to increase the 100.110.868 21.842.660 23.294.231 26.388.235 28.585.742 2.642.613 3.182.811 3.860.303 4.268.798 19.200.047 20.110.270 22.525.632 24.316.369 - 1.150 2.300 575 performance of the healthcare system Program 2.1: Ensure the functional framework and the 636.500 15.000 252.750 261.150 107.600 1.800 189.750 196.350 105.200 13.200 63.000 64.800 2.400 - - - - resources for the healthcare system Program 2.2: Improve the efficiency and quality of 82.209.698 18.283.225 19.121.517 21.493.437 23.311.519 2.379.019 2.519.870 2.649.417 2.797.043 15.904.206 16.600.497 18.841.720 20.513.901 - 1.150 2.300 575 healthcare services Program 2.3: Ensure patient access to medicine and medical 14.148.594 3.282.641 3.446.773 3.619.112 3.800.068 - - - - 3.282.641 3.446.773 3.619.112 3.800.068 - - - - devices Program 2.4: Upgrade the 3.116.076 261.794 473.191 1.014.537 1.366.555 261.794 473.191 1.014.537 1.366.555 ------healthcare system infrastructure 3 Strategic objective: Develop the institutional capacity of 23.142.208 4.356.016 6.014.291 6.419.925 6.351.975 2.050.823 2.423.846 2.666.812 2.283.062 2.293.670 3.577.769 3.739.169 4.053.575 11.524 12.676 13.944 15.338 management structures in the healthcare system Program 3.1: Improve the performance of strategic, regulatory and administration 23.142.208 4.356.016 6.014.291 6.419.925 6.351.975 2.050.823 2.423.846 2.666.812 2.283.062 2.293.670 3.577.769 3.739.169 4.053.575 11.524 12.676 13.944 15.338 institutions in the healthcare system Total ISP 159.752.852 34.171.186 38.057.635 42.543.574 44.980.458 5.337.081 6.665.259 7.664.980 7.671.100 28.822.581 31.378.550 34.862.350 37.293.445 11.524 13.826 16.244 15.913

Annex 1c: Measures and Financial Resources by financing source 2017-2020 (thousand RON)

non- non- non- non- cofinancin cofinancin cofinancin cofinancin reimbur reimbur reimbur reimbur g of non- g of non- g of non- g of non- state state state state sable sable sable sable total ISP total ISP total ISP total ISP total ISP reimbursa reimbursa reimbursa reimbursa budget budget budget budget funds funds funds funds ble funds ble funds ble funds ble funds (EU et (EU et (EU et (EU et (EU et al.) (EU et al.) (EU et al.) (EU et al.) al.) al.) al.) al.) Budgetary program/ Measure 2017-2020 2017 2018 2019 2020 2017 2018 2019 2020 2017 2018 2019 2020 2017 2018 2019 2020 Program 1.1: Prevention and control of 26.623.080 6.087.871 6.553.819 6.839.249 7.142.141 6.087.871 6.438.819 6.724.249 7.027.141 - 100.000 100.000 100.000 - 15.000 15.000 15.000 non-communicable diseases Measure 1.1.1.1 Develop and implement mechanisms for prevention, diagnostic, 9.063.338 2.124.224 2.245.515 2.312.072 2.381.528 2.124.224 2.188.015 2.254.572 2.324.028 - 50.000 50.000 50.000 - 7.500 7.500 7.500 treatment and control of cardiovascular diseases Measure 1.1.1.2 Develop and implement mechanisms for prevention, diagnostic, 10.128.148 2.257.819 2.488.619 2.621.085 2.760.624 2.257.819 2.465.619 2.598.085 2.737.624 - 20.000 20.000 20.000 - 3.000 3.000 3.000 treatment and control of oncologic diseases Measure 1.1.1.3 Develop and implement mechanisms for prevention, diagnostic, 4.652.339 1.055.300 1.142.620 1.198.087 1.256.332 1.055.300 1.108.120 1.163.587 1.221.832 - 30.000 30.000 30.000 - 4.500 4.500 4.500 treatment and control of diabetes mellitus Measure 1.1.1.4 Prevention and control 1.751.582 429.000 433.450 440.099 449.033 429.000 433.450 440.099 449.033 ------of mental and behavior disorders Measure 1.1.1.5 Promote a healthy 6.959 1.499 1.649 1.814 1.996 1.499 1.649 1.814 1.996 ------lifestyle and combat the main risk factors Measure 1.1.2.1 Develop medical services 1.020.715 220.029 241.966 266.092 292.628 220.029 241.966 266.092 292.628 ------for patients with special pathologies Program 1.2: Prevention and control of 9.643.546 1.850.795 2.134.166 2.799.135 2.859.451 1.848.495 2.069.766 2.734.735 2.803.101 2.000 56.000 56.000 49.000 300 8.400 8.400 7.350 communicable diseases Measure 1.2.1.1 Strengthen the system of prevention, surveillance and control of 71.660 8.241 20.401 21.119 21.900 8.241 8.901 9.619 10.400 - 10.000 10.000 10.000 - 1.500 1.500 1.500 communicable diseases Measure 1.2.1.2 Strengthen the system of prevention, surveillance and control of 146.813 23.120 41.417 43.834 38.442 21.970 24.167 26.584 29.242 1.000 15.000 15.000 8.000 150 2.250 2.250 1.200 priority communicable diseases – tuberculosis Measure 1.2.1.3 Strengthen the system of prevention, surveillance, detection, diagnostic, treatment and monitoring of 6.258.131 1.214.775 1.259.514 1.880.764 1.903.078 1.214.775 1.225.014 1.846.264 1.868.578 - 30.000 30.000 30.000 - 4.500 4.500 4.500 priority communicable diseases – viral hepatitis Measure 1.2.1.4 Strengthen the system of prevention, surveillance and control of 1.911.577 443.508 465.684 488.968 513.416 443.508 465.684 488.968 513.416 ------priority communicable diseases - HIV/ AIDS Measure 1.2.2.1 Protect the population health against main communicable 1.255.365 161.150 347.150 364.450 382.615 160.000 346.000 363.300 381.465 1.000 1.000 1.000 1.000 150 150 150 150 diseases that can be prevented through vaccination Program 1.3: Improving mother and child 140.369 32.006 33.606 36.055 38.703 32.006 33.606 36.055 38.703 ------health Measure 1.3.1.1 Early detection and assessment of risks during pregnancy for 29.260 6.538 6.865 7.551 8.306 6.538 6.865 7.551 8.306 ------both mother and child Measure 1.3.1.2 Measures of early 36.267 8.103 8.509 9.359 10.295 8.103 8.509 9.359 10.295 ------detection and assessment of child 45

non- non- non- non- cofinancin cofinancin cofinancin cofinancin reimbur reimbur reimbur reimbur g of non- g of non- g of non- g of non- state state state state sable sable sable sable total ISP total ISP total ISP total ISP total ISP reimbursa reimbursa reimbursa reimbursa budget budget budget budget funds funds funds funds ble funds ble funds ble funds ble funds (EU et (EU et (EU et (EU et (EU et al.) (EU et al.) (EU et al.) (EU et al.) al.) al.) al.) al.) Budgetary program/ Measure 2017-2020 2017 2018 2019 2020 2017 2018 2019 2020 2017 2018 2019 2020 2017 2018 2019 2020 diseases with increasing incidence, such as autism spectrum disorders Measure 1.3.1.3 Measures aimed at improving child nutrition and other 74.843 17.364 18.233 19.144 20.101 17.364 18.233 19.144 20.101 ------measures for specific diseases Program 1.4: Monitoring public health in 92.781 1.838 27.522 60.974 2.447 1.838 2.022 2.224 2.447 - 20.400 47.000 - - 5.100 11.750 - connection with the environment Measure 1.4.1.1 Monitor and report on the determining factors from the living 8.531 1.838 2.022 2.224 2.447 1.838 2.022 2.224 2.447 ------and working environment Measure 1.4.2.1 Consolidate monitoring services for the determining factors from 84.250 - 25.500 58.750 ------20.400 47.000 - - 5.100 11.750 - the living and working environment Program 2.1: Ensure the functional framework and the resources for the 636.500 15.000 252.750 261.150 107.600 - - - - 12.500 216.500 223.500 93.000 2.500 36.250 37.650 14.600 healthcare system Measure 2.1.1.1 Human resource 414.000 - 161.000 161.000 92.000 - - - - - 140.000 140.000 80.000 - 21.000 21.000 12.000 Development Initiatives Measure 2.1.2.1 Initiatives to improve the 11.400 1.800 5.400 4.200 - - - - - 1.500 4.500 3.500 - 300 900 700 - management of financial resources Measure 2.1.3.1 Initiatives designed to 193.100 13.200 80.350 89.950 9.600 - - - - 11.000 67.000 75.000 8.000 2.200 13.350 14.950 1.600 improve information management Measure 2.1.4.1 Initiatives aimed at promoting research and innovation in the 18.000 - 6.000 6.000 6.000 - - - - - 5.000 5.000 5.000 - 1.000 1.000 1.000 health sector Program 2.2: Improve the efficiency and 82.209.698 18.283.225 19.121.517 21.493.437 23.311.519 18.283.225 19.095.192 21.461.287 23.284.894 - 22.500 27.500 22.500 - 3.825 4.650 4.125 quality of healthcare services Measure 2.2.1.1 Develop the community 1.281.107 289.000 310.350 325.523 356.235 289.000 303.450 318.623 350.485 - 6.000 6.000 5.000 - 900 900 750 healthcare services Measure 2.2.1.2 Extend the role of family 8.763.373 1.680.014 1.859.765 2.321.769 2.901.824 1.680.014 1.848.015 2.310.019 2.887.524 - 10.000 10.000 12.000 - 1.750 1.750 2.300 medicine services Measure 2.2.1.3 Develop the services in the specialty clinic and para-clinic 12.772.163 2.776.652 2.952.068 3.312.104 3.731.339 2.776.652 2.951.493 3.310.379 3.731.339 - 500 1.500 - - 75 225 - outpatient care Measure 2.2.2.1 Increase the efficiency 50.420.754 11.474.801 11.827.463 13.228.620 13.889.871 11.474.801 11.823.863 13.225.020 13.886.271 - 3.000 3.000 3.000 - 600 600 600 and performance of hospital services Measure 2.2.2.2 Reinforcement of 6.945.901 1.610.000 1.691.700 1.778.025 1.866.176 1.610.000 1.690.500 1.775.025 1.863.776 - 1.000 2.500 2.000 - 200 500 400 emergency healthcare services Measure 2.2.3.1 Develop the long-term healthcare services, 775.339 165.837 174.129 203.442 231.931 165.837 174.129 203.442 231.931 ------rehabilitation/medical recovery, home caregiving, palliation Measure 2.2.4.1 Improve the quality of 16.550 500 5.300 8.175 2.575 500 3.000 3.000 2.000 - 2.000 4.500 500 - 300 675 75 healthcare services Measure 2.2.5.1 Strengthen services for 729.876 169.340 177.807 186.697 196.032 169.340 177.807 186.697 196.032 ------organ, tissue and human cell transplant Measure 2.2.5.2 Ensure demand and 504.635 117.081 122.935 129.082 135.536 117.081 122.935 129.082 135.536 ------security of blood products Program 2.3: Ensure patient access to 14.148.594 3.282.641 3.446.773 3.619.112 3.800.068 3.282.641 3.446.773 3.619.112 3.800.068 ------medicine and medical devices Measure 2.3.1.1 Increase patient access 12.703.836 2.947.440 3.094.812 3.249.553 3.412.030 2.947.440 3.094.812 3.249.553 3.412.030 ------46

Annex 2: Institutional Strategic Plan (Summary Table)

Reference Target Target Unit value 2019 2020 Improving the health of the population through Strategic objective 1: measures of morbidity prevention and control Impact indicator No. 1.1: The gap between the life expectancy and healthy life 12,4 Years 12,3 12,2 expectancy in men (71,4-59) Impact indicator No. 1.2: The gap between the life expectancy and healthy life 19,7 Years 19,5 19,3 expectancy in women (78,7-59)

Program 1.1: Prevention and control of non-communicable diseases

Result 1.1.1: Reduce the prevalence of risk factors for non-communicable diseases Outcome indicator: Standardized rate of deaths caused by chronic diseases in persons aged below 65 Cases/ 100,000 219 217 217 Outcome indicator: Suicide mortality rate Cases/ 100,000 9,5 9,3 9,3

Outcome indicator: Percentage of daily adult smokers % 20% 19% 18% Outcome indicator: Percentage of adults with harmful alcohol % 69% 67% 66% consumption

Result 1.1.2: Ensure access to early detection, diagnosis and / or treatment for

specific diseases % 9% 10% 10% Outcome indicator: Coverage of target group for cervical cancer screening Cases/ 100,000 34,24 34 34 Outcome indicator: Cervical cancer incidence

Outcome indicator: Cervical cancer mortality Cases/ 100,000 14,75 13 12

Reference Target Target Unit value 2019 2020

Program 1.2: Prevention and control of communicable diseases

Result 1.2.1: Reduce the incidence and prevalence of priority infectious diseases ICUs - ICUs - Outcome indicator: Incidence of nosocomial infection with MDR % ICUs - 5% microorganisms 5% 5% & & & Surgeries - Surgeries Surgeries 3% - 3% - 3% Outcome indicator: Standardized TB incidence 63 Cases/ 100,000 60 60 Outcome indicator: Standardized HIV/AIDS incidence 1,99 Cases/ 100,000 1,9 1,9 1,11 Outcome indicator: Standardized hepatitis B incidence Cases/ 100,000 1 1 Result 1.2.2: Increase the compliance rate to the vaccinations included in the

National Immunization Calendar Outcome indicator: Vaccination coverage for children of 12 and 24 months % of target group 80% 85% 85% as part of the national immunization calendar

Outcome indicator: Incidence of selected diseases preventable by vaccination (rubella and poliomyelitis) Cases/ 100,000 0.3/ 0 0.3/ 0 0.3/ 0

Program 1.3: Improve the health status of the mother and child

Result 1.3.1: Improve mother and child health

Outcome indicator: Mother mortality at birth (per 1000 live births) Cases/ 1000 live 0,1 0,1 0,1 births

Cases/ 1000 live Outcome indicator: Infant mortality rate (per 1000 live births) births 7,97 7,9 7,9

Reference Target Target Unit value 2019 2020 Cases/ 1000 live Outcome indicator: Perinatal mortality rate (per 1000 live births) births 7,08 6,8 6,8 Cases/ 1000 live births Outcome indicator: Neonatal mortality rate 0-6 days (per 1000 live births) 3,17 3 2,9

Program 1.4: Monitoring public health in relation with the environment

Result 1.4.1: Reduction in diseases linked to environmental risk factors Outcome indicator: Number of occupational diseases Cases 1025 820 800 Result 1.4.2: Reduction of the negative impacts of environmental catastrophes

occurring at infrastructure sites exposed to environmental risks Outcome indicator: Map of areas posing risks for human health (industrial facilities, large chemical plants, routes of transportation for chemical, Yes/ no No Yes Yes radioactive or hazardous materials, areas with high risk of floods of earthquakes) Cross-cutting measures to increase the performance of Strategic objective 2: the healthcare system Impact indicator No.2.1: Territorial distribution of physicians (ratio between averages of quartile 4 and Ratio q4/q1 2,9 2,7 2,6 quartile 1 of county rates of physicians per 100,000 population) Program 2.1: Ensure the functional framework and the resources for the

healthcare system Result 2.1.1: Ensure the human resources, in order to provide the healthcare

services at an agreed quality level Physicians and Outcome indicator: Coverage with available medical staff at national level 280/ 583 285/ 590 287/ 595 nurses/ 100,000 50

Reference Target Target Unit value 2019 2020 Result 2.1.2: Ensure sustainable funding for the healthcare sector Outcome indicator: Total healthcare expenditures (%GDP) % 5,1 5,2 5,3 Result 2.1.3: Develop the Health Integrated IT System, by implementing sustainable e-health solutions No of fully Outcome indicator: Level of development of the IPSI (Information operational IPSI 4 6 6 Platform of Social Insurance) components Result 2.1.4: Develop the research and innovation capacity in the health sector Outcome indicator: Applications resulted from the research projects, 0 4 5 transferred into medical practice (no) No of local government units 165 130 100 without family Impact indicator No.2.2: physician

Territorial coverage with primary care services No of local government units without specialty care 2767 2650 2600 providers Impact indicator No.2.3: No of cases/ 100.000 1035 950 900 Rate of reimbursed hospital admissions for conditions treatable in outpatient care

Program 2.2: Improve the efficiency and quality of healthcare services

Result 2.2.1: Increase the provision of preventive services for the population through primary care Outcome indicator: % of local government units (LGU) where there is at

Reference Target Target Unit value 2019 2020 least one family doctor for every 2000 inhabitants % of LGU 50% 52% 53% Outcome indicator: number of towns without specialist outpatient care providers Number of LGU 57 0 0 Result 2.2.2: Rationalize and increase efficiency for hospital healthcare services Outcome indicator: No of acute beds Beds per 1,000 4,2 4 4 inhabitants

Outcome indicator: Admission rate for acute cases Cases per 1,000 19 18 18 inhabitants 11 11 11 Outcome indicator: Average response time to emergencies minutes Result 2.2.3: Develop the palliative assistance to be provided to terminal patients and for long-term recovery Outcome indicator: Beds for long term care (per 1.000 inhabitants at least Beds/ 1.000 5 6 6 65 years old) Beds/ 100.000 18 20 20 Outcome indicator: Beds for palliative care (per 100.000 inhabitants) Beds/ 100.000 160 166 166 Outcome indicator: Beds for long-term care (per 100.000 inhabitants) Result 2.2.4: Increase the quality of healthcare services, irrespective of the level where they are supplied Outcome indicator: Legal frame allowing the integration and/ or Yes/ no No Yes Yes coordination of services providers approved

Outcome indicator: Centralized reports on patient satisfaction cover #% of the hospital services providers % 0% 100% 100% Result 2.2.5: Improve the outcomes of blood transfusions and organ transplant services Outcome indicator: Number of transplants per %0000 inhabitants Transplants/ 1000000 65 67 68 52

Reference Target Target Unit value 2019 2020 Quantity of Outcome indicator: Ensure self-sufficiency for blood transfusions transfused blood and 180000 180000 180000 plasma (liters)

Program 2.3: Ensure patient access to medicines and medical devices

Result 2.3.1: Increase the number of patients who have access to medicines needed to control or treat chronic conditions No of pieces of legislation approved Outcome indicator: Updates to the reimbursed medicines list 3 3 3 % Outcome indicator: Share of generic drugs in total reimbursed drugs 27% 29% 30%

Result 2.3.2: Reduce waiting lists for medical devices

Outcome indicator: Standardize the information on the names and Medical devices No Yes Yes characteristics of medical devices and healthcare supplies registry operational

Program 2.4: Modernization of the health infrastructure

Result 2.4.1: Decrease the inequity of access to healthcare services through the development of infrastructure Outcome indicator: Population covered by newly-built regional hospitals %, number of regions (as % and number of regions) 0%; 0 0%; 0 39%; 3 Outcome indicator: Density of operational radio-therapy equipment compliant with EU standards, per types of equipment Units/ 100,000 53

Reference Target Target Unit value 2019 2020 0,36 0,42 0,45 : Develop the institutional capacity of management Strategic objective 3 structures in the healthcare system Impact indicator 3.1: Percentage of Romanians who trust the HC system % 27%30 30% 30% Program 3.1: Improve the performance of strategic, regulatory and

administration institutions in the healthcare system Result 3.1.1: Implement and use best practice tools in the healthcare administration Outcome indicator: Number of best practice tools used in the healthcare No of units 2 3 4 administration Result 3.1.2: Increase efficiency of the public policy formulation and

implementation processes in the healthcare sector % of draft pieces of Outcome indicator: Percentage of public policies with impact studies 10% 15% 15% legislation Result 3.1.3: Increase productivity of the human capital in the healthcare

administration Outcome indicator: Percentage of management personnel who must meet % of approved 0% 15% 15% annual performance targets positions

30 Eurobarometer no. 411, Patient Safety and Quality of Care, data for Romania, European Commission, 2014, available at http://ec.europa.eu/public_opinion/index_en.htm 54

Annex 3: Programs and Related Measures (Summary Table) Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) Program 1.1: Prevention and control of non-communicable diseases

Measure 1.1.1.1 Develop and implement mechanisms for prevention, diagnostic, treatment and control of cardiovascular diseases The measure aims to design and implement an integrated approach of primary and secondary prevention services under the Institutional Strategic Plan. The program will focus more on the services provided by family physicians and specialized outpatient facilities. Emphasis will be given to interventions that counter the level of smoking and alcohol consumption, sedentary lifestyle and unhealthy eating habits. It will accomplish this by focusing on early detection of cardiovascular diseases risk and by reducing the risk of draft piece of cardiovascular diseases in asymptomatic adults. These will be legislation for Plan 0 0 1 0 0 the objectives of the National Cardiovascular Diseases Control approval [pieces of Plan. legislation] The interventions are aimed at both specific primary prevention as well as active early detection of cardiovascular diseases risk, diagnosis and treatment of cardiovascular diseases. The measure is financed from the state budget, European non- reimbursable funds (ENF) and National Health Insurance Fund (NHIF) and is to be implemented between 2017-2020. Implementing institutions: Ministry of Health (MoH), National Health Insurance House (NHIH), county public health departments (CHDs), county health insurance houses (CHIH), family physicians, community nurses, hospitals, other providers.

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) Measure 1.1.1.2 Develop and implement mechanisms for no of Babes-

prevention, diagnostic, treatment and control of oncologic Papanicolau tests 200.000 200.000 200.000 200.000 200.000 diseases [tests] This measure is aimed at lowering the cancer burden on the draft piece of population through early detection of the disease and through legislation for Plan 0 0 1 0 0 reducing specific mortality over the medium and long term, approval [pieces of through screening interventions organized at the national level, legislation] under the National Multiannual Integrated Plan for Cancer Control, with an emphasis on oncologic prevention. Emphasis is laid on implementing the national screening program for cervical cancer, on early detection interventions, through population screening for the other two eligible types of cancer (breast and colorectal cancer), and through patient monitoring and palliative community activities, by: 1. Infrastructure no of cancer development; 2. Testing, diagnosis and treatment for the medication

insured and non-insured; 3. providing human resources. The beneficiaries as 110.000 110.000 110.000 110.000 110.000 diagnosis and treatment of oncologic diseases will be conducted part of the NHP in an integrated manner. [persons] The measure is financed from the state budget, European non- reimbursable funds (ENF) and National Health Insurance Fund (NHIF) and is to be implemented between 2017-2020. Implementing institutions: MoH, NHIF, medical care units, outpatient care units, paraclinical service providers, family physicians, community nurses. Measure 1.1.1.3 Develop and implement mechanisms for draft piece of prevention, diagnostic, treatment and control of diabetes legislation on the mellitus national diabetes 0 0 1 0 0 The measure provides for the drafting of a National Plan for plan [pieces of Diabetes Control. The plan will be aimed at lowering the legislation] no of diabetes prevalence of risk factors, at detecting new diabetes cases, most medication often asymptomatic, and at detecting chronic complications of 700.000 700.000 700.000 700.000 700.000 diabetes, educating patients in an ongoing manner on changing beneficiaries as 56

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) their life style, ensuring compliance with the prescribed therapy part of the NHP and at preventing chronic complications and providing [persons] monitoring tests. Diabetes patients will benefit from services at all levels of care: case management in primary care; medicines, tests and devices through the NHIH’s Diabetes National Program; hospital services and medical devices for case with complications and comorbidities. The measure is financed from the state budget, European non- reimbursable funds (ENF) and National Health Insurance Fund (NHIF) and is to be implemented between 2017-2020. Implementing institutions: MoH, NHIF, medical care units, family physicians, community nurses. Measure 1.1.1.4 Prevention and control of mental and behavior disorders The measure aims at (i) promoting and protecting mental health, (ii) preventing psychological morbidities and (iii) hospital beds for ensuring adequate access to diagnosis, treatment and follow-up metal health 0,8 0,8 0,8 0,8 0,8 services. At activity level, the measure will put emphasis on the problems [beds/ implementation of the National Strategy for Mental Health of 1,000] Children and Youths 2016-2020, mental health promotion projects, preventive interventions, diagnosis, treatment and monitoring of patients. A special focus will be given to the role

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) of primary care providers, especially community care assistants and family physicians, who will be trained and encouraged to get involved in detecting and treating patients with mental and behavior disorders. schools in which The measure is financed from the state budget, European non- preventive 600 600 600 600 600 reimbursable funds (ENF) and National Health Insurance Fund interventions are (NHIF) and is to be implemented between 2017-2020. carried out [units] Implementing institutions: MoH, NHIF, National Public Health Institute regional departments, medical care units, outpatient care units, family physicians, community nurses.

national campaigns to 1 1 1 1 1 promote mental health [campaigns]

Measure 1.1.1.5 Promote a healthy lifestyle and combat the information campaigns main risk factors 22 22 22 22 22 The actions are aimed at strengthening the capabilities of health implemented promotion agencies and effective implementation of specific [campaigns] campaigns. As stated in the NHS, a national Plan for Health number of Promotion will be developed, which will provide reference for educational units subsequent development and implementation of county health in which specific 2134 2134 2134 2134 2134 promotion plans. The NPHI will carry out studies of the health interventions are status and health determinants and will then adjust the existing carried out [units] personnel trained awareness campaigns to their findings. The campaigns will 120 120 120 120 120 in health

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) focus on preventing and fighting alcohol consumption, promotion at smoking, as well as joint actions with the Ministry of Education regional and and the Ministry of Youth and Sports, aimed at promoting county level healthy eating habits and a healthy life style. [persons] The measure is financed from the state budget, European non- draft piece of reimbursable funds (ENF) and National Health Insurance Fund legislation for (NHIF) and is to be implemented between 2017-2020. approval of the Implementing institutions: MoH, ISPs, National Public Health national Plan for 0 0 1 0 0 Institute regional departments, outpatient care units, family Health Promotion physicians, community nurses. [pieces of legislation] Measure 1.1.2.1 Develop medical services for patients with draft regulation of special pathologies the approval of National Plan for The measure concerns the early detection, diagnosis and 0 0 1 0 0 treatment of rare diseases included in the NHIH’s national Rare Diseases program for treatment of rare diseases, as well as hemophilia [pieces of and thalassemia. It will seek to consolidate and extend the legislation] infrastructure for diagnosis and treatment by supporting the set up and the operations of centers of expertise for rare diseases, as envisaged by the order of MoH no 540/2016. Also, support will be given to reference labs authorized to perform diagnosis no of rare disease tests. Patients with rare disease will continue to have access to medication specific medicines and to services at all levels of care. beneficiaries as 3518 3518 3518 3518 3518 The measure is financed from the state budget, European non- part of the NHP reimbursable funds (ENF) and National Health Insurance Fund [persons] (NHIF) and is to be implemented between 2017-2020. Implementing institutions: MoH, NHIF, National Public Health Institute regional departments, medical care units. Program 1.2: Prevention and control of communicable diseases

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) Measure 1.2.1.1 Strengthen the system of prevention, personnel trained surveillance and control of communicable diseases under the National This measure is aimed at diseases preventable through Plan for vaccination, water-borne diseases, food-borne diseases and Intervention in 50 50 50 50 50 zoonoses, blood-borne infections, hospital-acquired infections, Case of Epidemics STI, HIV, TB and other priority diseases. The measure aims to and Pandemics support surveillance infrastructure, upgrade IT equipment and [persons] epidemiological software for implementing the electronic studies, reports, surveillance system, surveillance and control of hospital- surveys 1 1 1 1 1 acquired infections and monitor the use of antibiotics and the [documents] antibiotic resistance. The measure is financed from the state budget, European non- reports, surveys on reimbursable funds (ENF) and is to be implemented between the nosocomial 2 2 2 2 2 2017-2020. infections Implementing institutions: MoH, National Public Health [documents] Institute (NPHI), National Public Health Institute regional departments, CHDs, family physicians, hospitals, other providers. draft piece of legislation for the approval of the National Strategic 0 1 0 0 0 Plan on Nosocomial Infections [pieces of legislation] Measure 1.2.1.2 Strengthen the system of prevention, National Plan for surveillance and control of priority communicable diseases – TB Awareness 0 0 1 0 0 tuberculosis developed The measure includes activities for developing and [documents] implementing the Framework Action Plan for Countering centralized Tuberculosis, the surveillance infrastructure, ensuring access to procurement of TB 1 0 1 0 1 integrated services or patient-centered care and prevention: 1. medicines 60

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) Improving the programmatic management and intervention [tenders] capacity for the prevention and control of TB, especially of MDR/XDR forms. 2. Increasing the diagnosis capacity for TB/MDR TB and ensuring universal access to high quality diagnosis, in compliance with international standards. 3. Improving treatment conditions and ensuring the access of all patients to first and second line TB drugs. Special emphasis will be laid on detecting tuberculosis in the passive form (in symptomatic patients, who see the physician on their own initiative) and the active, intensive form (through contacts control, and through the control of persons with TB risk), by mobilizing family physicians and community nurses. The measure is financed from the state budget, European non- reimbursable funds (ENF) and National Health Insurance Fund (NHIF) and is to be implemented between 2017-2020. Implementing institutions: MoH, NHIF, health care units, family physicians, community nurses. Measure 1.2.1.3 Strengthen the system of prevention, surveillance, detection, diagnostic, treatment and monitoring of hepatitis registry priority communicable diseases – viral hepatitis operational [yes/ no yes yes yes yes The measure includes integrated activities aimed at reducing no] morbidity, invalidity and mortality determined by acute viral, protracted and chronic forms of hepatitis B, C and D, cirrhosis of the liver caused by these viruses through activities related to prevention, screening, treatment and follow-up. no of screened The measure is financed from the state budget, European non- persons for HCV reimbursable funds (ENF) and National Health Insurance Fund and HBV 13.000 13.000 13.000 13.000 13.000 (NHIF) and is to be implemented between 2017-2020. [persons] Implementing institutions: MoH, NHIF, health care units, family physicians, community nurses.

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) Measure 1.2.1.4 Strengthen the system of prevention, no of screened surveillance and control of priority communicable diseases - 370.000 370.000 370.000 370.000 370.000 persons [persons] HIV/ AIDS This measure is aimed at implementing epidemiologic National surveillance activities through clinical and lab examinations for Multiparty HIV the general population and for the population segments with a Committee no no yes yes yes high risk of contracting sexually transmitted diseases and operational [yes/ infections, as well as ensuring patient access to services of no] prevention, diagnosis, treatment and monitoring of the HIV/AIDS infection. The measure is financed from the state budget, European non- no of antiretroviral reimbursable funds (ENF) and National Health Insurance Fund treatment (NHIF) and is to be implemented between 2017-2020. beneficiaries 10.551 10.551 10.551 10.551 10.551 [persons] Implementing institutions: MoH, NHIF, health care units, family physicians. Measure 1.2.2.1 Protect the population health against main National communicable diseases that can be prevented through Vaccination vaccination Registry yes yes yes yes yes This measure is aimed at continuing the vaccination coverage operational [yes/ for all vaccines and age groups provided in the national no] immunization calendar. It includes regulatory changes to draft piece of improve compliance, a national awareness campaign on the legislation on benefits and safety of vaccination, the setup of the National vaccination 0 1 0 0 0 Committee for Vaccination, training of personnel involved in [pieces of vaccination and investment in the vaccination network legislation] infrastructure. no of national campaigns A series of legislative measures are foreseen for the transfer of 1 1 1 1 1 the Cantacuzino NIRDMI to the Ministry of Health and for implemented financing it based on its status as provider of economic services [campaigns] of general interest to ensure the investments necessary for the % cases of resumption of vaccine production. vaccination 100% 100% 100% 100% 100% adverse events

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) The measure is financed from the state budget, European non- investigated of reimbursable funds (ENF) and is to be implemented between total reported [%] 2017-2020. counties in which vaccination rates Implementing institutions: MoH, NPHI, CHDs, NIRDMI 30 30 30 30 30 Cantacuzino31, family physicians, community nurses. are below optimal levels [counties] draft piece of legislation of the transfer of the 0 1 0 0 0 institute to the MoH [pieces of legislation] Program 1.3: Improving mother and child health

Measure 1.3.1.1 Early detection and assessment of risks during public policy pregnancy for both mother and child proposal on the The measure is aimed at conducting prenatal investigations, health state on improving medical care services and monitoring for pregnant children, including 1 0 0 1 0 women, women who have recently given birth, and newborns. cross-sector activities The measure is financed from the state budget, European non- [documents] reimbursable funds (ENF) and National Health Insurance Fund (NHIF) and is to be implemented between 2017-2020. % of children benefiting from Implementing institutions: MoH, NHIF, CHDs, CHIHs, family preventive iron ≥ 50% ≥ 50% ≥ 50% ≥ 50% ≥ 50% physicians, community nurses, hospitals, other providers. supplements as per guidelines [%] report on reproduction 1 1 1 1 1 health

31 National Institute for Research and Development in Microbiology and Immunology (Institutul National de Cercetare, Dezvoltare pentru Microbiologie si Imunologie, in Romanian) 63

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) [documents] no of maternity units included in "Child friendly 10 10 10 10 10 hospital" initiative [persons] Measure 1.3.1.2 Measures of early detection and assessment of child diseases with increasing incidence, such as autism spectrum disorders Given the magnitude and the high costs entailed, both for the family and for the healthcare system, the measure initially provides conducting a national-level epidemiologic study and guidelines for then designing interventions based on its findings. Such pregnant women interventions might include the early detection and assessment and children of neurodevelopmental disorders, including: child autism, 1 1 1 1 1 updated/ Asperger disorder, disintegrative childhood disorder, Rett developed syndrome and pervasive developmental disorders not otherwise [documents] specified (PDD-NOS), or typical autism. The measure is financed from the state budget, European non- reimbursable funds (ENF) and is to be implemented between 2017-2020. Implementing institutions: MoH, NHIH, health care units, family physicians. Measure 1.3.1.3 Measures aimed at improving child nutrition and other measures for specific diseases The measure aims at the promotion of breastfeeding; the pregnant women micronutrient diet supplementation of the pregnant woman and receiving advice 50% 50% 50% 50% 50% infant baby; the prophylaxis of malnutrition in low birth weight given on breast children; the healthy diet and the prevention of child obesity. It feeding [%] also envisages the development of studies and research concerning mother and child health and related determining factors. 64

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) The measure is financed from the state budget, European non- reimbursable funds (ENF) and is to be implemented between 2017-2020. Implementing institutions: MoH, NHIF, health care units, family physicians. Program 1.4: Monitoring public health in connection with the environment

Measure 1.4.1.1 Monitor and report on the determining factors from the living and working environment This measure includes activities aimed at monitoring the quality of the drinking water and bathing water, correlating health indicators with various pollutants in the surrounding air, analyzing the impact of industrial and household waste on general health, monitoring the waste management system for annual report on waste generated by the medical activities, monitoring food the determining quality, risk assessment. It will finance research studies of factors from the factors with a potentially negative impact on public health will living and working 1 1 1 1 1 be conducted under this measure. Based on the findings of all environment research and monitoring activities, accident/ catastrophe released response guidelines and procedures will be updated/ developed. [documents] The measure is financed from the state budget, European non- reimbursable funds (ENF) and is to be implemented between 2017-2020. Implementing institutions: MoH, NPHI, National Public Health Institute regional departments, CHDs, family physicians, other providers.

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) Measure 1.4.2.1 Consolidate monitoring services for the determining factors from the living and working environment This measure is aimed at supporting the surveillance no of risk maps 0 0 0 42 42 infrastructure through the national level mapping of risk factors [maps] that could impact human health (industrial facilities, large chemical plants, routes of transportation for chemical, radioactive or hazardous materials, facilities for poultry no of trained processing, areas with high risk of floods of earthquakes), 42 42 42 42 42 persons [persons] consolidating and modernizing laboratory equipment in public institutes and public health directorates. All personnel involved in response to environmental emergencies will be trained in the guidelines, procedures and mapping results. In addition, based on the mapping and research, further measures to strengthen the no of laboratories response capacity and infrastructure will be designed. 42 42 42 42 42 upgraded [labs] The measure is financed from the state budget, European non- reimbursable funds (ENF) and is to be implemented between 2017-2020. Implementing institutions: MoH, INSP, ISPs, CHDs. Program 2.1: Ensure the functional framework and the resources for the healthcare system

Measure 2.1.1.1 Human resource development initiatives The measure aims at developing and implementing an no of trained 130.537 130.537 130.537 130.537 130.537 integrated HR development policy for the healthcare sector. It nurses [persons] entails the development of a plan for the human resources in healthcare, identification and implementation of sustainable draft regulations strategies for attracting and retaining doctors and nurses in the and guidelines on Romanian health sector, especially in understaffed specialties human resources 2 2 2 2 2 and areas. The plan will put emphasis on increasing mobility developed [pieces with a view to improving the territorial distribution of medical of legislation] staff. The measure also points to the development of unitary number of ICA 180 ICA 180 ICA 180 ICA 180 ICA 180 criteria for work norming, quality, evaluation and monitoring graduates in Epidemiology Epidemiology Epidemiology Epidemiology Epidemiology

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) the activities conducted by medical staff. It includes actions deficient 40 40 40 40 40 designed to increase efficiency of training programs. The specialties Hygiene 25 Hygiene 25 Hygiene 25 Hygiene 25 Hygiene 25 measure also foresees the development and implementation of a [persons] Emergency Emergency Emergency Emergency Emergency motivating payment system for the medical staff. medicine 127 medicine 127 medicine 127 medicine 127 medicine 127 The measure is financed from the state budget, European non- Lab medicine Lab medicine Lab medicine Lab medicine Lab medicine reimbursable funds (ENF) and National Health Insurance Fund 94 94 94 94 94 (NHIF) and is to be implemented between 2017-2020. Psychiatry Psychiatry Psychiatry Psychiatry Psychiatry Implementing institutions: MoH, CHDs, NPHI and its network, 153 153 153 153 153 College of Physicians. Pediatric Pediatric Pediatric Pediatric Pediatric psychiatry 20 psychiatry 21 psychiatry 22 psychiatry 23 psychiatry 24 draft piece of legislation on the approval of a new 0 1 0 0 0 remuneration system [pieces of legislation] draft piece of legislation on the human resource 0 1 0 0 0 strategy approval [pieces of legislation] Measure 2.1.2.1 Initiatives to improve the management of draft piece of financial resources legislation on the The measure includes actions designed to develop the service approval of new contracting and payment systems, to improve the efficiency of payment spending in the national health programs. It foresees actions mechanisms for 0 0 0 1 0 aimed at improving the reimbursement and reporting systems, services within as well as policies to increase the financial resources for national health healthcare services. programs [pieces of legislation]

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) The measure is financed from the state budget, European non- number of public reimbursable funds (ENF) and National Health Insurance Fund budgets developed (NHIF) and is to be implemented between 2017-2020. based on program 0 0 0 3 0 Implementing institutions: MoH, NHIF and service providers. budgeting [budgets] public policy on private health 0 0 1 0 0 insurance [documents] Measure 2.1.3.1 Initiatives designed to improve information draft piece of management legislation on The Measure aims at ensuring the standardization, integration harmonization of service and interoperability of the healthcare information system, 0 0 1 0 0 developing an integrated health IT system, i.e. the Information classification, Platform of Social Insurance, strengthening or developing IT codification and solutions for the healthcare services, under e-health projects, reporting [pieces developing patient or disease registries, and improving the use of legislation] of IT&C solutions in the emergency services. ICD 10 classification The measure is financed from the state budget, European non- system extended to reimbursable funds (ENF) and National Health Insurance Fund family medicine (NHIF) and is to be implemented between 2017-2020. 0 0 1 0 0 and specialist Implementing institutions: MoH, NHIF, CHDs, CHIHs, service outpatient care providers. [pieces of legislation] no of operational components of the 4 4 4 5 6 IT platform [components]

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) no of new operational registries, 4 4 4 4 4 complying with EU standards [registries] regional cancer and cancer screening no no no no yes registries operational [yes/ no] Measure 2.1.4.1 Initiatives aimed at promoting research and draft piece of innovation in the health sector legislation on The Measure aims at developing the research and innovation amending capacity for the health sector, including public health and regulations for 0 1 0 0 0 healthcare services, to support evidence-based policies. It also clinical studies focuses on improving the framework for clinical studies. The [pieces of National Plan for Healthcare Research will be updated and will legislation] include mechanisms for the transfer of research projects’ results into policies and clinical practice. The measure is financed from the state budget, European non- final report 0 0 1 0 0 reimbursable funds (ENF) and is to be implemented between [documents] 2017-2020. Implementing institutions: MoH, NHIF, CHDs, CHIHs and health R&D units. Program 2.2: Improve the efficiency and quality of healthcare services

Measure 2.2.1.1 Develop the community healthcare services no of community assistants and This measure is aimed at implementing and extending the 1867 1867 1867 1867 1867 community healthcare services with a view to providing health mediators [persons] 69

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) primary prevention services and facilitating the access of draft piece of vulnerable groups to basic healthcare services. It also seeks to legislation on the ensure integration with other providers of healthcare service, community care 0 1 0 0 0 education and social services. [pieces of The activities under this measure will relate to employment and legislation] qualification of more community care assistants, the integrated improvement of the legal framework, development of community care 0 0 0 0 200 guidelines for community interventions, training of community teams [teams] assistants and other stakeholders, designing better mechanisms for monitoring and evaluation of community care assistants’ work. The beneficiaries are members of the community healthcare no of guidelines network and the population of the relevant local communities. and methodologies This measure is financed from the budget of MoH, through the developed and 1 1 1 1 1 Swiss-Romanian cooperation program and has a permanent disseminated character/ shall apply until 2020. [documents] Implementing institutions: Ministry of Health (MoH), National Health Insurance House (NHIH), county health departments (CHDs), county health insurance houses (CHIH), family physicians, community nurses, hospitals, other providers. Measure 2.2.1.2 Extend the role of family medicine services diagnostic and This measure seeks to increase the coverage and quality of prescription support software family medicine services, extend the scope and frequency of no no no no yes preventive services, improve the management of chronic purchased and disease patients, integrate family medicine with other healthcare operational [yes/ services. no] draft legislation on The activities under this measure will consist of identifying pay-for- patients at risk of chronic conditions and patients with high risk performance of complications, inclusion of high risk patients in case 0 0 0 0 1 management practices, offering physicians software for mechanism for selected services diagnosis and prescription support, designing and implementing provided by family

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) pay-for-performance mechanisms, designing new incentives for physicians [pieces attracting physicians in underserved areas, providing financial of legislation] support to 24/7 centers and integration via telemedicine with no of communes hospitals’ emergency rooms. The measure will finance the without family 165 165 165 165 165 ongoing medical services delivered by family physicians. practitioner Beneficiaries shall be family doctors and insured patients [communes] registered in their lists. draft piece of The measure is financed from the state budget, European non- legislation on reimbursable funds (ENF), National Health Insurance Fund incentives for (NHIF) and World Bank loan and is to be implemented between family physicians 2017-2020. and resident 0 0 1 0 0 Implementing institutions: Ministry of Health (MoH), National physicians for Health Insurance House (NHIH), county health insurance relocation in houses (CHIH), family physicians. service deficient areas [pieces of legislation] no of operational permanence 1481 1481 1481 1481 1481 centers [centers] draft piece of legislation on allowing the residency program 0 0 1 0 0 in the family care practice [pieces of legislation] Lab medicine Lab medicine Lab medicine Lab medicine Lab medicine Measure 2.2.1.3 Develop the services in the specialty clinic and no of outpatient - 105 - 105 - 105 - 105 - 105 para-clinic outpatient care physicians in Radiology- Radiology- Radiology- Radiology- Radiology- This measure is aimed at preparing and implementing a public deficient medical medical medical medical medical policy dedicated to the expansion of specialty outpatient specialties imaging - 155 imaging - 155 imaging - 155 imaging - 155 imaging - 155 services with a view to improving coverage and facilitating [persons] Pneumology - Pneumology - Pneumology - Pneumology - Pneumology -

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) patient access to high-quality outpatient diagnosis and treatment 70 71 72 73 74 services. The measure will support the outpatient medical centers providing (a) imagery diagnosis services, (b) surgery and procedures performed without admission to a hospital (c) draft legislation on screening services for cancer and (d) specialized care for pay-for- complications occurred in chronic diseases. performance Other activities within this measure will consist of designing mechanism for and implementing new payment mechanisms, which will selected services 0 0 0 0 1 encourage the multidisciplinary approach for same-day provided by diagnosis and treatment services, outpatient surgery, more outpatient numerous chronic disease management services. The measure physicians [pieces will provide support to hospitals converted into outpatient of legislation] clinics. It will finance the ongoing medical services delivered draft piece of by specialist physicians, the outpatient paraclinical services and legislation on the the dialysis national health program. approval of the The measure is financed from the state budget, European non- Strategy for 0 0 1 0 0 reimbursable funds (ENF), National Health Insurance Fund outpatient care (NHIF) and World Bank loan and is to be implemented between [pieces of 2017-2020. legislation] Implementing institutions: Ministry of Health (MoH), National no of dialysis Health Insurance House (NHIH), county health insurance patients under 12100 12100 12100 12100 12100 houses (CHIH), service providers. treatment [persons] Lab medicine Lab medicine Lab medicine Lab medicine Lab medicine no of outpatient - 105 - 105 - 105 - 105 - 105 physicians in Radiology- Radiology- Radiology- Radiology- Radiology- deficient medical medical medical medical medical specialties imaging - 155 imaging - 155 imaging - 155 imaging - 155 imaging - 155 [persons] Pneumology - Pneumology - Pneumology - Pneumology - Pneumology - 70 71 72 73 74

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) Measure 2.2.2.1 Increase the efficiency and performance of report on the DRG hospital services system released 0 0 0 1 0 This measure is aimed at increasing the efficiency of [documents] expenditure and the quality of hospital services through draft piece of rationalizing the network and pursuing integration at regional legislation on the level, standardization of hospital organization and equipment, approval of and improving the payment methods for services. standards for This measure includes activities related to the provision of organization and high-quality hospital services, based on the optimal endowment of 0 0 1 0 0 combination of human and technological resources, hospitals based on rationalization of hospital network services, integration of level of hospital services with other healthcare providers, increasing the competence efficiency of financing and improvements to the classification, [pieces of organization and operation of hospitals. legislation] The measure is financed from the state budget, European non- draft piece of reimbursable funds (ENF), National Health Insurance Fund legislation on the (NHIF) and World Bank loan and is to be implemented between setup and 2017-2020. functioning of 0 0 0 1 0 Implementing institutions: Ministry of Health (MoH), National centers of Health Insurance House (NHIH), county health departments excellence [pieces (CHDs), county health insurance houses (CHIH), hospitals. of legislation] draft piece of legislation on the coordination of hospital services 0 0 1 0 0 by regional hospitals [pieces of legislation] isolated communities 160 160 160 160 160 connected to hospitals by

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) telemedicine systems [l.g. units] Measure 2.2.2.2 Reinforcement of emergency healthcare no of integrated services operations centers 41 41 41 41 41 This measure is aimed at ensuring the provision of emergency [centers] pre-hospital and hospital services, concurrently with the paper-free implementation of projects for the development of the network. communication This Measure includes actions to ensure the functionality of system within no no no yes yes emergency pre-hospital services and to further develop the emergency units emergency hospital services through roll-out of integrated it and transport [yes/ systems, expanded telemedicine facilities and upgrade of no] emergency transport capabilities. The measure is financed from the state budget, European non- reimbursable funds (ENF), the World Bank loan and is to be implemented between 2017-2020. ambulances Implementing institutions: Ministry of Health (MoH), Ministry 1941 1941 1941 2858 2858 available [units] of Internal Affairs, county health departments (CHDs), hospitals, ambulance service.

Measure 2.2.3.1 Develop the long-term healthcare services, draft piece of rehabilitation/medical recovery, home caregiving, palliation legislation on the The measure foresees the implementation of specific services approval of the for palliative assistance provided to terminally ill patients and National Plan for for long-term recovery. It consists of actions aimed at drawing long term, 0 0 0 1 0 up and approving national policies concerning specific services rehabilitation , for palliative care provided to terminal patients and for long- home and paliative term recovery, including financing sources and mechanisms, care [pieces of and at implementation of specific palliative services provided to legislation] terminally ill patients and for long-term recovery. beneficiaries of The measure is financed from the state budget, European non- home medical 45.743 45.743 45.743 45.743 45.743 reimbursable funds (ENF) and National Health Insurance Fund services [persons]

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) (NHIF) and is to be implemented between 2017-2020. Implementing institutions: Ministry of Health (MoH), National Health Insurance House (NHIH), county health insurance houses (CHIH), long-term care and palliative services providers, family physicians, community nurses, hospitals. Measure 2.2.4.1 Improve the quality of healthcare services no of clinical The measure is aimed at creating the foundation for increasing guidelines and the quality of medical services, through the expansion of the protocols for provider accreditation system, development of clinical audit improving service hospital hospital hospital hospital hospital capacity, development of clinical guidelines, integration of quality newly Procedures Procedures Procedures Procedures Procedures providers at various levels of care around patients with specific developed or 142 142 142 142 142 chronic diseases and the advancement of the interaction with amended, Protocols 72 Protocols 72 Protocols 72 Protocols 72 Protocols 72 patients. including clinical pathway The measure includes actions intended to develop and [documents] implement accreditation standards, implement quality control diagnostic and mechanisms, update clinical guidelines, extend the supply of prescription evidence-based services, promote the multi-disciplinary support software approaches to the patient and ensure the continuity of care, no no no no yes purchased and extend health technology assessment systems, integrate service providers, improve the mechanisms for the information of and operational [yes/ no] communication with patients. draft piece of The measure is financed from the state budget, European non- legislation on the reimbursable funds (ENF), National Health Insurance Fund rules for approval (NHIF), National Agency for Healthcare Quality Management and update of 0 0 1 0 0 budget and the World Bank loan and is to be implemented clinical guidelines between 2017-2020. [pieces of Implementing institutions: MoH, NHIH, the National Agency legislation] for Healthcare Quality Management (NAHQM), specialist no of providers 180 public 180 public 180 public 180 public 180 public MoH advisory committees, services providers. evaluated and private and private and private and private and private [providers] hospitals hospitals hospitals hospitals hospitals

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) draft piece of legislation on the approval of accreditation 0 0 0 1 0 standards for primary care providers [pieces of legislation] draft piece of legislation on the amendment of accreditation 0 0 1 0 0 standards for hospitals [pieces of legislation] national registry for near-miss/ adverse events 0 0 0 yes yes operational [yes/ no] no of trained persons in guideline 100 100 100 100 100 implementation [persons] draft piece of legislation on the HTA framework for services, 0 0 0 1 0 devices, equipment and public health interventions 76

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) [pieces of legislation] no of integrated functional care networks at area/ 0 0 0 2 8 county level [networks] draft piece of legislation on the piloting of integrated functional care 0 0 1 0 0 networks at area/ county level [pieces of legislation] national health portal operational 0 0 0 yes yes [yes/ no] draft piece of legislation on the approval of minimum 0 0 0 1 0 standards for health providers’ webpages [pieces of legislation] annual report on patient satisfaction 0 1 1 1 1 released [documents]

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) Measure 2.2.5.1 Strengthen services for organ, tissue and draft piece of human cell transplant legislation on the The measure seeks to ensure continuity and development of approval of services for organ, tissue and cell transplant. It aims at guidelines for 0 0 1 0 0 improving budgetary efficiency and access to post-transplant organ transplant medicines. [pieces of legislation] The actions included in the measure concern the development no of beneficiaries of guidelines for each transplant phase, the actual of post-transplant implementation of transplant procedures and associated 3278 3278 3278 3278 3278 measures, developing proposals to reform financing medicines [persons] mechanisms and prescription and dispensing medicine for post- transplant patients. draft legislation on The measure is financed from the state budget and National the disbursements for organ Health Insurance Fund (NHIF) and is to be implemented 0 0 1 0 0 between 2017-2020. transplant services Implementing institutions: MoH, NHIH, National Agency for [pieces of Transplant, services providers. legislation] Measure 2.2.5.2 Ensure demand and security of blood products no of donors 345.598 345.598 345.598 345.598 345.598 The measure aims at ensuring sufficient quantities of secure [persons] blood products and developing providers’ capacity. The actions envisaged by the measure center upon the operation of blood transfusion centers and investment in service infrastructure. no of centers 41 41 41 41 41 The measure is financed from the state budget, European non- upgrades [centers] reimbursable funds (ENF). Implementing institutions: MoH, the National Institute for Transfusion Hematology and its subordinated centers, services providers. Program 2.3: Ensure patient access to medicine and medical devices

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) Measure 2.3.1.1 Increase patient access to compensated draft piece of medicines in financially sustainable conditions legislation on the The measure aims at increasing the quality of decisions mechanism for setting regarding medicines reimbursement, as well as the NHIH 1 1 0 0 0 related expenditure. prescription medicines prices The measure includes actions intended to review the [pieces of methodology for setting the price of prescription medicines, so legislation] as to ensure the adequate supply of the local market, to draft piece of strengthen the administrative capacity of the staff in the unit for health technology assessment (HTA) within National Drugs and legislation on amendments to the Medical Devices Agency (NDMDA), to review the HTA 0 1 0 1 0 HTA system regulations by including cost-effectiveness criteria in decision- [pieces of making, to extend the managed entry agreements for expensive legislation] new medicines, to ensure access to medicines, with or without personal contribution, for patients with chronic or acute conditions and to monitor the physicians` prescription behavior. The measure is financed from the state budget, European non- no of MEAs reimbursable funds (ENF), National Health Insurance Fund concluded 4 4 4 4 4 (NHIF) and World Bank loan and is to be implemented between [contracts] 2017-2020. Implementing institutions: regulatory bodies in the central administration (MoH, NHIF, NDMDA), CHIHs. Measure 2.3.2.1 Increase patient access to medical devices no of beneficiaries The measure aims at improving the quality of life for patients of medical devices 266.000 266.000 266.000 266.000 266.000 with organic or functional deficiencies and at standardizing the [persons] medical devices and supplies used in Romania. The measure includes actions intended to ensure patients` access to medical devices designed for the recovery of organic registry or functional deficiencies, in line with the basic medical operational [yes/ no no no yes yes services package or the national health programs, and to set up no] and implement a Nomenclature of medical devices and healthcare supplies. 79

Measure 2.4.1.1 Upgrade service provider infrastructure to the number of regional hospitals in current standards of healthcare services and the patients’ needs 0 0 3 3 3 This measure is aimed at achieving rationalization and construction conversion of local hospitals, the development and [hospitals] no of upgraded rationalization of county hospitals (rehabilitated for increasing 14 14 14 14 14 their energy efficiency, upgrading to improve physical access hospitals [projects] for the disabled and the provision of equipment), rationalization integrated and/ or building of regional hospitals, increasing the efficiency community centers of integrated outpatient services in the treatment of complex upgraded/ built, 45 45 45 45 45 pathologies requiring multi-disciplinary approaches. It also equipped and seeks to upgrade the infrastructure of radio-therapy and staffed [projects] oncology services. radiotherapy The measure will provide support for setting up/ refurbishing/ centers upgraded/ 1 1 1 1 1 building integrated community care centers, integrated health built [projects] centers and family practices in remote areas. Similar support is intended for primary care permanence centers set up with the aim of providing services round the clock for the population in outpatient clinics designated areas. upgraded/ built/ 87 87 87 87 87 The measure is financed from the state budget, European non- equipped reimbursable funds (ENF), National Health Insurance Fund [projects] (NHIF) and World Bank loan and is to be implemented between 2017-2020. Implementing institutions: Ministry of Health (MoH), National

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) Health Insurance House (NHIH), county health departments (CHDs), county health insurance houses (CHIH), hospitals. Measure 2.4.1.2 Development of public health infrastructure This measure is aimed at improving the infrastructure of public health laboratories, to perform investments in infrastructure, technology and the equipment and to provide the adequate 42 PHD labs 43 PHD labs 44 PHD labs 45 PHD labs 46 PHD labs infrastructure to manage medical waste. DSP + 17 DSP + 17 DSP + 17 DSP + 17 DSP + 17 no of upgrade LIR - DSP + LIR - DSP + LIR - DSP + LIR - DSP + LIR - DSP + The measure is financed from the state budget, European non- projects [projects] reimbursable funds (ENF) and is to be implemented between 17 labs 17 labs 17 labs 17 labs 17 labs 2017-2020. RPHC RPHC RPHC RPHC RPHC Implementing institutions: Ministry of Health (MoH), county health departments (CHDs), NIPH, National Public Health Institute regional departments. Measure 2.4.1.3 Development of the infrastructure for emergency services The measure consists of upgrading and extending emergency rooms in emergency hospitals, providing the appropriate specific equipment for ambulance and SMURD services and of upgraded extending the coverage of SMURD services at national level. emergency rooms 29 29 29 29 29 The measure is financed from the state budget, European non- [projects] reimbursable funds (ENF) and World Bank loan and is to be implemented between 2017-2020. Implementing institutions: Ministry of Health (MoH), Ministry of Internal Affairs, county health departments (CHDs), ambulance services, hospitals. Program 3.1: Improve the performance of institutions with strategic, regulatory, administration, representation role in the healthcare system

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) Measure 3.1.1.1 Develop integrity, transparency and professional ethics personnel trained The measure is aimed at strengthening and extending the in inspection and 90 90 90 90 90 integrity and control structures of the Ministry of Health; control topics reviewing patient feedback mechanisms; preventing and [persons] identifying situations that may create conflicts of interest among clinical and management personnel of public health annual report for providers; developing a new mechanism of financial support for national health life-long medical education; improving mechanisms of 1 1 1 1 1 programs accountability for managers and other representatives of the [documents] decision-making apparatus in hospitals; transparent use and publication of public funds. analyses, reports, The measure is financed from the state budget, European non- evaluations to reimbursable funds (ENF) and National Health Insurance Fund substantiate public 1 1 1 1 1 (NHIF) and is to be implemented between 2017-2020. policies Implementing institutions: MoH, NHIH, National Integrity [documents] Agency, CHDs, CHIHs, public hospitals, other providers. Measure 3.1.1.2 Develop the administrative capacity of institutional centralized public procurement framework for This measure aims at implementing the strategic planning for RHSPs operational medical technologies procurement and related implementation (committees at 0 1/ 8 1/ 8 1/ 8 1/ 8 activities for every type of selected medical technology. national and Another objective is to develop the MoH administrative regional level) capacity to perform centralized public procurement procedures [committees] efficiently and effectively. The measure is financed from the state budget, European non- no of trained persons in public reimbursable funds (ENF) and World Bank loan and is to be 0 0 10 10 10 implemented between 2017-2020. procurement Implementing institutions: Ministry of Health (MoH), public [persons] hospitals.

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) Measure 3.1.1.3 Increase institutional performance by improving the management systems The measure aims at strengthening the methodological coordination of the audit compartments from the healthcare units subordinated to the MoH, developing the managerial internal control system, developing IT instruments for internal procedures, strengthening the state sanitary inspection, and improving the management capacity for managed entry no of new IT agreements. The measure also seeks to establish a mechanism systems, for prioritizing budgetary allocations and making evidence- management based decisions at MoH and NHIH level. Additional activities 0 1 2 2 2 systems and relate to the establishment within the MoH and NHIH of a joint trained persons mechanism for monitoring and control of suppliers in the health [persons] insurance system and of a mechanism for tracking medicines on the Romanian market. The measure is financed from the state budget, European non- reimbursable funds (ENF) and National Health Insurance Fund (NHIF) and is to be implemented between 2017-2020. Implementing institutions: Ministry of Health (MoH), National Health Insurance House (NHIH), county health departments (CHDs)32, county health insurance houses (CHIH)33, NDMDA. Measure 3.1.2.1 Promote healthcare in all policies draft piece of The measure aims at improving the MoH capacity for policy legislation on the formulation and the strategic planning cycle in the healthcare amendment of public policy sector. It also seeks to ensure enough staff capable to formulate 0 0 1 0 0 healthcare policies, develop strategies and coordinate the proposal format programs and measures from the Institutional Strategic Plan. and content The measure includes activities to develop procedures and [pieces of legislation]

32 Directorate for Public Health (Directia de Sanatate Publica, in Romanian) 33 County Health Insurance Agency (Casa Judeteana de Asigurari de Sanatate, in Romanian) 83

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) instruments for the formulation of public policies and strategies, no of joint projects 1 1 1 1 1 for monitoring, evaluating and reviewing the ISP and the [projects] National Healthcare Strategy; for development of impact studies. The measure also points to the development of partnerships and joint programs with the stakeholders from associated fields (local public authorities, social, education, environment, police, emergency situations, transportation); to the drafting and implementation of the legal framework for consultations with the social stakeholders and other NGOs. no of trained 0 3 3 3 3 The measure is financed from the state budget, European non- persons [persons] reimbursable funds (ENF) and is to be implemented between 2017-2020. Implementing institutions: Ministry of Health (MoH), National Health Insurance House (NHIH), other stakeholders from associated fields (social services, education, environment, internal affairs, transportation etc.). Measure 3.1.2.2 Promote evidence-based public policies draft piece of The measure is aimed at conducting studies on the usage of legislation health services, the performance of the health system, the developed and 0 0 1 0 0 financing of health services, the management and leadership debated [pieces of capacity of the health system. It seeks to implement monitoring legislation] & evaluation system for the National Health Strategy 2014- report of the health 2020. It also refers to implementation of research projects, survey 0 0 0 1 0 studies or surveys on the determinants of health and disease [documents] burden in the population. The measure includes the development and implementation of a public policy and related regulations regarding investments in healthcare infrastructure, as well as a multiannual plan for investment in public hospitals. annual evaluation 1 1 1 1 1 The measure is financed from the state budget, European non- report [documents] reimbursable funds (ENF) and World Bank loan and is to be implemented between 2017-2020. Implementing institutions: Ministry of Health (MoH), National 84

Budgetary program Output indicator Baseline Target 2017 Target 2018 Target 2019 Target 2020 Measure description (unit) Health Insurance House (NHIH), other stakeholders from associated fields (social services, education, environment, internal affairs, transportation etc.). Measure 3.1.3.1 Develop the human capital from the MoH, NHIF and other subordinated/coordinated institutions The measure aims at developing the human capital of healthcare regulatory bodies, by introducing modern HR management tools, conducting needs assessment and planning interventions to close the gaps, improving the staff’s recruitment and motivational factors, introducing performance- based incentives, promoting life-long learning practices, final report implementing specialized training programs and developing the 0 0 0 1 0 [documents] organizational culture. The measure is financed from the state budget, European non- reimbursable funds (ENF) and National Health Insurance Fund (NHIF) and is to be implemented between 2017-2020. Implementing institutions: Ministry of Health (MoH), National Health Insurance House (NHIH), county health departments (CHDs), county health insurance houses (CHIH), other subordinated institutions.

Annex 4: Institutional profile, internal and external assessment Main determinants of the health status

At the sub-national level, there are major differences in the determinants of the health status (socio-economic, behavioral factors, factors deriving from the physical life and work environment or individual characteristics). The strategies meant to influence their distribution and amplitude place significant emphasis on health promotion and primary care professionals. a. Socio-economic factors (directly or indirectly) play a significant role in shaping public health status, including in the broader meaning of health as defined by WHO, particularly on access to healthcare services. Healthcare is an important pillar in the multi-dimensional approach to mitigate poverty and social exclusion34, a significant goal of the European growth strategy by 202035.

Romania has one of the highest levels of poverty in the EU. Approximately 37% of the population live on the edge of poverty and social exclusion risk, a level that is exceeded in the EU-28 only by Bulgaria36. b. Environmental factors. Traditional environmental determinants contribute 17% to the burden of disease in Romania, or the equivalent of 30 DALY/1,000 inhabitants per annum37. Recent studies reveal that four out of the top 15 risk factors, depending on the disease, pertain directly to the environment38. The main pathologies known to have environmental components are: respiratory, cardio-vascular, neurologic diseases, but also some forms of cancer. c. Individual behavioral factors. The behaviors with well-known impact on health status - smoking, alcohol abuse, diet/obesity and physical inactivity - weigh heavily on the health status of the overall population but with notable differences in impact by gender.

Tobacco abuse. Smoking is the third cause of disease for men and fifth for women. The estimated percentage of daily smokers in Romania is 19.6% in 2015, slightly lower than in 2013. Compared to other European countries, Romania is labelled as an average risk country in relation to tobacco abuse.

Alcohol abuse among Romanians continues to be the highest in Europe (RO: 16.3 l/adult/year39, EU27: 12.45 l/adult/year in 2012), exceeding by 30% the European average40.

34 EHMA, The role of health care sector in tackling poverty and social exclusion in Europe, 2004 35 Regulation (EU) No 282/2014 of the European Parliament and of the Council of 11 March 2014 on the establishment of a third Programme for the Union's action in the field of health (2014-2020) and repealing Decision No 1350/2007/EC (1) Health for Growth 2014-2020 programme, European Commission 36 Eurostat, 2015. 37 WHO, Country profiles of Environmental Burden of Disease-Romania, Public Health and the Environment, Geneva 2009 . Accessed on 15 October 2013 la http://www.who.int/ quantifying_ehimpacts/national/countryprofile/romania.pdf 38 Exposure to suspension powder, the quality of home air, occupational risks and lead exposure. 39 Out of which 3 liters is consumption not registered in official records. 40 Anderson P, Alcohol in the European Union Consumption, harm and policy approaches, WHO & EC, 2012. 86

Available health data – e.g., number of hospital admissions attributed to alcohol, the overall and average hospital stay etc. – point to a significant public health concern.41

Physical inactivity is the fourth most significant cause of disease amongst Romanian women. In absolute terms men are even more impacted by physical inactivity than women. Recent MoH data on physical activity expect a worsening trend from 37% in 2013 to 33% in 201542.

Inappropriate diet. In accordance to NPHSA, a large percentage of Romanians eat too much salt (53%), saturated fats (32%) and/or red meat (27%)43.

Overweight/obesity. The prevalence of obesity in adults is relatively low in Romania (~8%), for the time being, the lowest in the EU-28 and one-third the European maximum figures (26% in Hungary and UK).44,45 As for the overweight population, the results of NPHSA reveal that 54% of persons assessed by family doctors had excess weight46.

High blood pressure in Romanian adults reaches 40%, according to the SEPHAR I and II surveys 47 and even 49.5%, based on intermediate data of SEPHAR III. The population group with the highest HBP risk are middle-aged women in urban areas, from the Southern region, with secondary education (high-school) and low income, non-smoking and with a sedentary lifestyle.

Institutional arrangements and capabilities referring to sector development

Apart from the health indicators described above, which are influenced by determinants inside and outside the health sector, the performance of the health system may also be assessed by: • Ability to respond to the beneficiary’s needs (responsiveness), • Equity and financial protection • Efficiency and sustainability

The ability to respond to beneficiaries’ needs is a key concern of the health system. It is captured both by systematic measurements in relation to the satisfaction and perception of users, and by its reflection in public debate and mass-media. A 2014 Eurobarometer on the satisfaction of EU citizens with healthcare revealed that Romanians were the most discontented, with 73% of respondents describing service quality as “bad”48.

41 Romanian Association for the Promotion of Health, Study on the economic impact of harmful alcohol consumption on the Romanian health system, 2012. 42 MoH, Report on the evaluation of the NHS 2014-2020, Bucharest, 2015, available at www.ms.ro. 43 National Healthcare Strategy 2014-2020, p. 16, Government Decision no 1028/2014. 44 Eurostat, Overweight and obesity - BMI statistics, November 2011. Accessed on 4 November 2013 on http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Overweight_and_obesity_-_BMI_statistics. 45 OECD, Health at a Glance: Europe 2012, Accessed on 4 November 2013 la http://www.oecd-ilibrary.org. 46 National Healthcare Strategy 2014-2020, p. 16, Government Decision no 1028/2014. 47 Romanian Hyper-Tension Society, Studiul de Prevalență a Hipertensiunii Arteriale și evaluare a riscului cardiovascular în România (SEPHAR), Copiilor si Tinerilor din Romania, 2011. Accessed on 4 November 2013 at http://www.sephar.ro/; Dorobantu M et co., Profile of the Romanian Hypertensive Patient, Data from SEPHAR II Study, ROM. J. INTERN. MED., 2012, 50, 4, 285–296 48 Eurobarometer no. 411, Patient Safety and Quality of Care, data for Romania, European Commission, 2014, available at http://ec.europa.eu/public_opinion/index_en.htm 87

Corruption in healthcare is addressed at two levels: higher level corruption – in public procurement – and petty corruption in the form of informal payments for medical services. Projects in both areas have been pursued in 2014. As a first step towards attempting to curb informal payments, a feedback mechanism for patients is now being tested. Ethical Councils in hospitals are not yet functional, but a methodology for their operation is now being developed. They will be tasked with the analysis of patients' reports of possible ethical breaches and deeds of corruption.

Equity and financial protection. Social health insurance coverage has been fluctuating in recent years: from 87.8% of the population in 2008 to 95.9% in 2010 and then down to 85.3% in 2012. Throughout this period, a 20 p.p. gap existed between the coverage of population in urban and rural areas.

In terms of medical service coverage, urban areas are clearly better than rural areas for all categories of medical services. At the national level, the density of family doctors is 0.5/1,000 inhabitants in rural areas, as compared to 0.6/1,000 inhabitants in urban, while other specialist clinical services are virtually absent in rural areas. The urban-rural gaps and geographic inequalities are reflected in the health status indicators, like infant mortality49.

The level of financial protection. Based on the 2013 Family Budget Survey of the National Statistical Institute, the healthcare expenses of households ranked fourth highest, amounting to 4.8% of total. According to the World Bank50, there are major differences in access to healthcare between people by income. In the case of chronic diseases, approximately 40% of individuals in the lowest quintile did not seek care, as compared to only 17% in the highest quintile.

Efficiency and financial sustainability. The inefficiencies of Romania’s public spending on healthcare have been repeatedly pointed out by reports of the World Bank, the International Monetary Fund and the European Union. They all emphasize the overreliance on hospital spending, also shown in Figure 2 above, and the small share of outpatient care. NICE International’s 2012 report also stated that: “there is relative under-financing in the primary and outpatient healthcare sector” and this is associated with structural and financing abnormalities which seem to have resulted in “apparent under-use of primary healthcare”, an “apparent over-use of hospital healthcare” and, as a consequence, to an extended transfer of costs entailing perverse incentives51.

Romania has undergone a multi-year effort to reduce the size of the hospital sector, marked with the reduction of the number of beds contracted with the NHIH, the closure of 60 hospitals and the stimulation of day admissions. As a result, the number of continuous acute admissions reimbursed by the NHIH went down by 20% in the four years to 2015. However, NHIH reports and NSPHTIH data from Figure 3 and 4 point to the continuation of some hospital spending inefficiencies: (i) half of hospital admissions are emergencies; (ii) hospitals admit significantly more patients than they get paid for and, (iii) the number of high severity cases increased significantly since 2010, leading to a higher cost per patient, despite no visible change in the general morbidity.

49 NIS, Tempo database, accessed in December 2016. 50 World Bank, Functional Analysis of the Healthcare System in Romania, 2011 51 NICE International, Romania: Final Report, January 2012 88

5,000 100% 4,718 4,500 116% 116% 4,319 113% 113% 112% 4,108 4,109 95% 4,000 3,890

Thousands 3,560 3,557 100% 3,500 3,393 3,472 3,404 90% 3,000 2,500 85% 87% 88% 100% 2,000 85% 1,500 80% 88% 1,000 79% 75% 80% 78% 500 75% 73% 69% 0 70% 2010 2011 2012 2013 2014

reimbursed cases (NHIH) vs DRG reports - acute cases 2010 2011 2012 2013 2014 2015 NHIH reimbursed acute cases

DRG registered acute cases ordinary severe catastrophic

Figure 9 - Hospital cases classified under the DRG Figure 10 – Multiannual trend of acute cases by system (source: NSPHTIH) complexity (2010=100%) (source: NSPHTIH)

Institutional profile MoH subordinated institutions 1. Institutions financed from the state budget (up to 17,496 positions)

42 deconcentrated services in counties and the city of Bucharest Institutul Naţional de Sănătate Publică; Institutul Naţional de Medicină Sportivă; Institutul Naţional de Hematologie Transfuzională "Prof. Dr. C.T. Nicolau"; Agenţia Naţională de Transplant; Oficiul Central de Stocare pentru Situaţii Speciale; Registrul Naţional al Donatorilor Voluntari de Celule Stem Hematopoietice; Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale; Spitalul Tichileşti (leprozerie); serviciile de ambulanţă judeţene şi Serviciul de Ambulanţă Bucureşti - Ilfov.

2. Self-financed institutions (own revenues) (up to 45,850 positions)

58 public hospitals

3. Institutions financed both from the state budget and own revenues (up to 380 positions)

Institutul Naţional de Medicină Legală "Mina Minovici" Bucureşti; Institutul de Medicină Legală Iaşi; Institutul de Medicină Legală Cluj-Napoca; Institutul de Medicină Legală Timişoara; Institutul de Medicină Legală Craiova; Institutul de Medicină Legală Târgu Mureş; Centrul Naţional de Sănătate Mintală şi Luptă Antidrog Bucureşti; Academia de Ştiinţe Medicale.

4. Organizations under the authority of the MoH 89

Compania Naţională "Unifarm" - S.A. Bucureşti; Societatea Comercială "Antibiotice" - S.A. Iaşi.

5. Institutions under the coordination of the MoH (up to 75 positions)

Şcoala Naţională de Sănătate Publică, Management şi Perfecţionare în Domeniul Sanitar Bucureşti

NHIH subordinated institutions 42 county health insurance houses and of the city of Bucharest CASAOPSNAJ (health insurance house for employees in the army, public safety, national security and justice)

Pieces of legislation to be developed and approved in 2017 The following pieces of legislation will be developed and enacted in 2017. The listing and timing are the result of the ISP action plan, which included NHS action plan and Government Program 2017-2020 provisions. type piece of legislation recurrent by-law for 2017 to the GD on the approval of the Framework contract on the regime of medical services, medicines and devices within the social health insurance system 2016-2017 (joint MoH-NHIH order) recurrent Government decision on the approval of national health programs for 2017- 2018 recurrent by-law to the GD on the approval of national health programs for 2017-2018 on the programs implemented by the NHIH (NHIH order) recurrent by-law to the GD on the approval of national health programs for 2017-2018 on the programs implemented by the MoH (MoH order) new adopt a draft healthcare law new draft piece of legislation on the amendment of public policy proposal format and content (health in all policies initiative) new draft piece of legislation for approval of the national Plan for Health Promotion new draft piece of legislation on the human resource strategy approval new draft piece of legislation on the approval of the consolidated service plan new draft piece of legislation on the coordination of hospital services by regional hospitals new draft piece of legislation on the approval of standards for organization and endowment of hospitals based on level of competence new draft pieces of legislation for the multiannual investment plan in hospitals, procedures to authorize investments in public hospitals and endowment standards based on hospital competency level new draft piece of legislation on harmonization of service classification, codification and reporting new draft piece of legislation on the rules for approval and update of clinical guidelines new draft piece of legislation on the approval of integrated care pathways for the 20 most frequent diseases new draft piece of legislation on the setup and functioning of centers of excellence

90 new draft piece of legislation on the mechanism for setting prescription medicines prices new draft piece of legislation on amendments to the HTA system new draft piece of legislation on amending regulations for clinical studies Table 13 – Pieces of legislation to be enacted in the healthcare sector in 2017

Main pieces of legislation in the health sector Legea nr. 95/2006 privind reforma în domeniul sănătăţii, cu modificările și completările ulterioare Hotărârea Guvernului nr. 1028/2014 privind aprobarea Strategiei naţionale de sănătate 2014- 2020 şi a Planului de acţiuni pe perioada 2014-2020 pentru implementarea Strategiei naţionale ORDIN nr. 1.410 din 12 decembrie 2016 privind aprobarea Normelor de aplicare a Legii drepturilor pacientului nr. 46/2003 Ordinul ministrului sănătăţii şi al preşedintelui Casei Naţionale de Asigurări de Sănătate nr. 763/377/2016 privind aprobarea Normelor metodologice de aplicare în anul 2016 a Hotărârii Guvernului nr. 161/2016 pentru aprobarea pachetelor de servicii şi a Contractului-cadru care reglementează condiţiile acordării asistenţei medicale, a medicamentelor şi a dispozitivelor medicale în cadrul sistemului de asigurări sociale de sănătate pentru anii 2016-2017 ORDIN nr. 1.355 din 28 noiembrie 2016 privind componenţa, atribuţiile, regulamentul de organizare şi funcţionare al comisiilor de specialitate ale Ministerului Sănătăţii ORDIN nr. 1.376 din 6 decembrie 2016 pentru aprobarea Planurilor regionale de servicii de sănătate ORDIN nr. 1.365 din 29 noiembrie 2016 pentru modificarea şi completarea Ordinului ministrului sănătăţii nr. 867/2015privind aprobarea modului de administrare, finanţare şi implementare a acţiunilor prioritare pentru tratamentul endovascular al pacienţilor critici cu leziuni periferice acute Ordinul ministrului sănătăţii nr. 477/2009 privind înfiinţarea Registrului Naţional de Transplant, desemnarea persoanelor responsabile cu gestionarea datelor din Registrul Naţional de Transplant din cadrul unităţilor sanitare acreditate pentru efectuarea de transplant de organe şi stabilirea datelor necesare înregistrării unei persoane pentru atribuirea codului unic de înregistrare la Agenţia Naţională de Transplant Ordinul ministrului sănătăţii şi al preşedintelui Casei Naţionale de Asigurări de Sănătate nr. 674/252/2012 privind aprobarea formularului de prescripţie medicală electronică pentru medicamente cu şi fără contribuţie personală în tratamentul ambulatoriu şi a Normelor metodologice privind utilizarea şi modul de completare a formularului de prescripţie medicală electronică pentru medicamente cu şi fără contribuţie personală în tratamentul ambulatoriu Ordinul ministrului sănătăţii şi al preşedintelui Casei Naţionale de Asigurări de Sănătate nr. 1.605/875/2014 privind aprobarea modului de calcul, a listei denumirilor comerciale şi a preţurilor de decontare ale medicamentelor care se acordă bolnavilor în cadrul programelor naţionale de sănătate şi a metodologiei de calcul al acestora Hotărârra Guvernului nr. 161/2016 pentru aprobarea pachetelor de servicii şi a Contractului- cadru care reglementează condiţiile acordării asistenţei medicale, a medicamentelor şi a dispozitivelor medicale în cadrul sistemului de asigurări sociale de sănătate pentru anii 2016- 2017 Ordinul ministrului sănătăţii şi al preşedintelui Casei Naţionale de Asigurări de Sănătate nr. 3/1/2015privind modelul de contract, metodologia de negociere, încheiere şi monitorizare a modului de implementare şi derulare a contractelor de tip cost-volum/cost-volum-rezultat

Hotărârea Guvernului nr. 800/2016 pentru aprobarea Metodologiei privind modul de calcul şi procedura de avizare şi aprobare a preţurilor maximale ale medicamentelor de uz uman cu autorizaţie de punere pe piaţă în România ORDIN nr. 1.114 din 10 octombrie 2016 privind aprobarea Metodologiei pentru desfăşurarea concursului de rezidenţiat pe loc şi pe post în medicină, medicină dentară şi farmacie, sesiunea 20 noiembrie 2016 Ordinul ministrului sănătăţii publice şi al preşedintelui Casei Naţionale de Asigurări de Sănătate nr. 1.782/576/2006 privind înregistrarea şi raportarea statistică a pacienţilor care primesc servicii medicale în regim de spitalizare continuă şi spitalizare de zi ORDIN nr. 1.116 din 10 octombrie 2016 privind stabilirea specialităţilor deficitare pentru care se organizează rezidenţiat pe post în spitale clinice cu secţii clinice universitare, institute sau centre medicale clinice în sesiunea 20 noiembrie 2016 ORDIN nr. 1.123 din 12 octombrie 2016 pentru aprobarea datelor, informaţiilor şi procedurilor operaţionale necesare utilizării şi funcţionării dosarului electronic de sănătate (DES) al pacientului ORDIN nr. 1.096 din 30 septembrie 2016 privind modificarea şi completarea Ordinului ministrului sănătăţii nr. 914/2006pentru aprobarea normelor privind condiţiile pe care trebuie să le îndeplinească un spital în vederea obţinerii autorizaţiei sanitare de funcţionare ORDIN nr. 1.101 din 30 septembrie 2016 privind aprobarea Normelor de supraveghere, prevenire şi limitare a infecţiilor asociate asistenţei medicale în unităţile sanitare ORDIN nr. 658 din 2013 privind Lista medicamentelor, materialelor sanitare, echipamentelor medicale, echipamentelor de protecţie, a serviciilor, combustibililor şi lubrifianţilor pentru parcul auto, pentru care se organizează proceduri de achiziţie centralizate la nivel naţional ORDIN nr. 1.009 din 6 septembrie 2016 privind înregistrarea dispozitivelor medicale în baza naţională de date Ordinul ministrului sănătăţii nr. 867/2015 privind aprobarea modului de administrare, finanţare şi implementare a acţiunilor prioritare pentru tratamentul endovascular al pacienţilor critici cu leziuni periferice acute Ordinul ministrului sănătăţii nr. 449/2015 privind aprobarea modului de administrare, finanţare şi implementare a acţiunilor prioritare pentru tratamentul pacienţilor cu infarct miocardic acut Ordinul ministrului sănătăţii nr. 447/2015 privind aprobarea modului de administrare, finanţare şi implementare a acţiunilor prioritare pentru monitorizarea, tratamentul şi îngrijirea pacienţilor critici din secţiile ATI adulţi/copii şi terapie intensivă nou-născuţi ORDIN nr. 961 din 19 august 2016 pentru aprobarea Normelor tehnice privind curăţarea, dezinfecţia şi sterilizarea în unităţile sanitare publice şi private, tehnicii de lucru şi interpretare pentru testele de evaluare a eficienţei procedurii de curăţenie şi dezinfecţie, procedurilor recomandate pentru dezinfecţia mâinilor, în funcţie de nivelul de risc, metodelor de aplicare a dezinfectantelor chimice în funcţie de suportul care urmează să fie tratat şi a metodelor de evaluare a derulării şi eficienţei procesului de sterilizare ORDIN nr. 936 din 10 august 2016 pentru modificarea şi completarea Metodologiei de elaborare a programului de investiţii publice al Ministerului Sănătăţii şi de alocare de fonduri pentru cheltuieli de investiţii unităţilor publice din reţeaua Ministerului Sănătăţii, aprobată prin Ordinul ministrului sănătăţii nr. 512/2014 ORDIN nr. 931 din 5 august 2016 privind modificarea şi completarea Normelor tehnice de realizare a programelor naţionale de sănătate publică pentru anii 2015 şi 2016, aprobate prin Ordinul ministrului sănătăţii nr. 386/2015 Ordinul ministrului sănătăţii nr. 446/2015 privind aprobarea modului de administrare, finanţare şi implementare a acţiunilor prioritare pentru tratamentul pacienţilor critici cu leziuni traumatice acute

ORDIN nr. 871 din 19 iulie 2016 pentru aprobarea Procedurilor, standardelor şi metodologiei de evaluare şi acreditare a spitalelor Ordin nr. 27 privind modificarea Normelor tehnice de realizare a programelor naționale de sănătate curative pentru anii 2015 și 2016 2017-02-01 HG nr. 853/2016 Norme metodologice privind asistenta medicala transfrontaliera Ordin 185/2015 privind aprobarea Normelor tehnice de realizare a programelor naționale de sănătate curative pentru anii 2015 și 2016 Hotărârea nr. 629/2015 privind componenţa, atribuţiile, modul de organizare şi funcţionare ale Autorităţii Naţionale de Management al Calităţii în Sănătate ORDIN Nr. 861 din 23 iulie 2014 pentru aprobarea criteriilor şi metodologiei de evaluare a tehnologiilor medicale, a documentaţiei care trebuie depusă de solicitanţi, a instrumentelor metodologice utilizate în procesul de evaluare privind includerea, extinderea indicaţiilor, neincluderea sau excluderea medicamentelor în/din Lista cuprinzând denumirile comune internaţionale corespunzătoare medicamentelor de care beneficiază asiguraţii, cu sau fără contribuţie personală, pe bază de prescripţie medicală, în sistemul de asigurări sociale de sănătate, precum şi denumirile comune internaţionale corespunzătoare medicamentelor care se acordă în cadrul programelor naţionale de sănătate, precum şi a căilor de atac Hotărârea Guvernului nr. 720/2008 pentru aprobarea Listei cuprinzând denumirile comune internaţionale corespunzătoare medicamentelor de care beneficiază asiguraţii, cu sau fără contribuţie personală, pe bază de prescripţie medicală, în sistemul de asigurări sociale de sănătate ORDIN Nr. 1384 din 4 noiembrie 2010 privind aprobarea modelului-cadru al contractului de management şi a listei indicatorilor de performanţă a activităţii managerului spitalului public ORDONANŢĂ DE URGENŢĂ Nr. 71 din 20 noiembrie 2012 privind desemnarea Ministerului Sănătăţii ca unitate de achiziţii publice centralizată ORDONANŢĂ DE URGENŢĂ Nr. 77 din 21 septembrie 2011 privind stabilirea unei contribuţii pentru finanţarea unor cheltuieli în domeniul sănătăţii ORDIN Nr. 1199 din 26 iulie 2011 privind introducerea şi utilizarea clasificării RO DRG v.1 ORDIN Nr. 1144 din 7 iulie 2011 pentru aprobarea Normelor metodologice de organizare şi funcţionare a centrelor de sănătate multifuncţionale ORDIN Nr. 323 din 18 aprilie 2011 privind aprobarea metodologiei şi a criteriilor minime obligatorii pentru clasificarea spitalelor în funcţie de competenţă HOTĂRÂRE Nr. 346 din 31 martie 2011 privind desfiinţarea unor unităţi sanitare publice cu paturi din subordinea autorităţilor administraţiei publice locale HOTĂRÂRE Nr. 345 din 31 martie 2011 privind aprobarea pentru anul 2011 a Raportului comisiei de selecţie a unităţilor sanitare cu paturi care nu pot încheia contracte cu casele de asigurări de sănătate, precum şi a listei acestor unităţi sanitare HOTĂRÂRE Nr. 303 din 23 martie 2011 pentru aprobarea Strategiei naţionale de raţionalizare a spitalelor HOTĂRÂRE Nr. 151 din 23 februarie 2011 privind aprobarea Planului naţional de paturi pentru perioada 2011 - 2013 HOTĂRÂRE Nr. 144 din 23 februarie 2010 privind organizarea şi funcţionarea Ministerului Sănătăţii ORDIN Nr. 75 din 3 februarie 2010 pentru aprobarea Regulilor de bună practică farmaceutică LEGE Nr. 266 din 7 noiembrie 2008 *** Republicată - Legea farmaciei ORDONANŢĂ DE URGENŢĂ Nr. 68 din 28 mai 2008 privind vânzarea spaţiilor proprietate privată a statului sau a unităţilor administrativ-teritoriale cu destinaţia de cabinete medicale, precum şi a spaţiilor în care se desfăşoară activităţi conexe actului medical

ORDIN Nr. 365/1 din 22 februarie 2007 pentru aprobarea Normelor metodologice privind asigurările voluntare de sănătate ORDIN Nr. 886 din 19 iulie 2006 privind externalizarea serviciilor medicale şi nemedicale din unităţile sanitare ORDIN Nr. 824 din 5 iulie 2006 pentru aprobarea Normelor privind organizarea şi funcţionarea Inspecţiei Sanitare de Stat LEGE Nr. 263 din 16 iunie 2004 privind asigurarea continuităţii asistenţei medicale primare prin centrele de permanenţă HOTĂRÂRE Nr. 884 din 3 iunie 2004 privind concesionarea unor spaţii cu destinaţia de cabinete medicale LEGE Nr. 46 din 21 ianuarie 2003 Legea drepturilor pacientului ORDONANŢĂ Nr. 53 din 30 ianuarie 2000 privind obligativitatea raportării bolilor şi a efectuării vaccinărilor ORDONANŢĂ Nr. 124 din 29 august 1998 *** Republicată privind organizarea şi funcţionarea cabinetelor medicale