ASIAN VACCINATION INITIATIVE and Kyrgyz Republic National Immunization Program

FINANCING ASSESSMENT © 2002 Asian Development Bank All rights reserved

The findings, interpretations, and conclusions expressed in this publication do not necessarily represent the views of the Asian Development Bank or those of its member governments. The Bank does not guarantee the accuracy of the data included in this publication and accepts no responsibility for any consequences of their use.

Asian Development Bank P.O. Box 789 0980 Manila, Philippines Tel: (63-2) 632-4444 Fax: (63-2) 636-2444 Website: http://www.adb.org

ISBN 971-561-420-5 Publication Stock No. 010602 Contents

Illustrations and Tables iv Acknowledgments v Abbreviations vi Introduction vii

Kazakhstan 1 Summary 3 Background 5 Socioeconomic Indicators 5 Demographic and Health Indicators 6 Health System 9 National Immunization Program 11 Immunization Schedule 11 Organizational Structure 11 Legislative Framework 11 Vaccination Coverage 13 Future Financing 15 Key Issues 15 Financing Needs, Sources, and Gaps 22 Policy Options 23 Recommendations 25

Kyrgyz Republic 27 Summary 29 Background 31 Socioeconomic Indicators 31 Demographic and Health Indicators 32 Health System 34 National Immunization Program 37 National Immunization Plan 37 Organizational Structure 38 Vaccination Coverage 39 Future Financing 41 Key Issues 41 Financing Needs, Sources, and Gaps 51 Policy Options 55 Recommendations 57

Appendix: Persons Interviewed 59 References 60 Illustrations and Tables

Figures

1 Organization of Healthcare System 10 2 Vaccination Coverage by 12 Months of Age, 1991–1999 13 3 Overview of Vaccine Distribution 19 4 Organization of Healthcare System 35 5 Vaccination Coverage by 12 Months of Age, 1990–1999 39 6 Overview of Vaccine Distribution 42 Tables

1 Macroeconomic Indicators, 1990–1998 6 2 Trends in Healthcare Expenditure, 1991–1998 6 3 Demographic Indicators, 1989–1999 7 4 Health Indicators, 1990–1998 7 5 Routine Immunization Schedule, 2000 11 6 VII Cost Sharing, 1995–2000 16 7 Comparison of Vaccine Procurement and Estimated Requirements 18 8 Costs Associated with Adolescent and Adult Vaccines 18 9 Estimated Cost of Upgrading National Cold-Chain Equipment 20 10 Cost of Measles Campaign 22 11 Macroeconomic Indicators, 1990–1997 31 12 Trends in Government Healthcare Expenditure, 1990–1998 32 13 Demographic Indicators, 1989–1997 33 14 Health Indicators, 1990–1997 33 15 Schedule of Immunization in the Kyrgyz Republic 38 16 Summary of VII Vaccine Cost-Sharing Agreement, 2000–2005 41 17 Cost Estimates for Vaccines, 2001–2005 43 18 Cost Estimates for the Establishment of a National Regulatory Agency and National Surveillance Laboratory, 2001–2005 44 19 Equipment for Cold-Chain Upgrade, 2001–2005 45 20 Cost Estimates for Disposable Injection Equipment, 2001–2005 46 21 Estimated Cost of Improving Immunization Safety, 2001–2005 46 22 Cost Estimates for Training and Development Activities, 2001–2005 47 23 Cost Estimates for Social Mobilization Activities, 2001–2005 48 24 Cost Estimates for Research Activities, 2001–2005 49 25 Cost Estimates for Enhanced Surveillance Logistic Support, 2001–2005 50 26 Cost Estimates for National Measles and Rubella Mass Campaign 51 27 Projected Costs, EPI, 2001–2005 52 28 EPI Financing Gap, 2001–2005 52 29 Funding Gaps for Strengthened EPI, 2001–2005 53 Acknowledgments

This report was prepared in December 2000 by Greg Sam, consultant, for the Agriculture and Social Sectors Department (West) of the Asian Development Bank. The study was supervised by Indu Bhushan, Senior Project Economist, under the overall guidance of Edward M. Haugh, Manager, Education, Health, and Population Division (West), ADB. Camille Contreras and Elena Roces of ADB provided production support.

The author wishes to thank the following:

In Kazakhstan: WHO Liaison Office in Almaty; Ministry of Economy in Astana; Sanitary Epidemiological Stations in Astana, Almaty, Karaghanda, and Kozylorda; Republican Agency for Healthcare in Astana; and the UNICEF Office in Almaty.

In the Kyrgyz Republic: WHO Liaison Office, Ministry of Finance, Ministry of Health, State Sanitary Epidemiological Dept., Republican Center for Immunoprophylaxis, State Com- mittee on Foreign Investments and Economic Development, and UNICEF Office—all in Bishkek.

The persons in those offices who were interviewed for this report are listed in Appendix 1.

Special thanks also go to the staff of the ADB resident missions in the two countries. Abbreviations

ADB Asian Development Bank AEFI adverse effects following immunization BCG bacillus Calmette-Guérin (anti-TB vaccine) CCME ? CDC Centers for Disease Control, Atlanta, US D diphtheria toxoid vaccine DAT diphtheria anti-toxin DPT or DTP diphtheria and tetanus toxoids and pertussis vaccine DT diphtheria and tetanus vaccine EPI Expanded Program on Immunization FAP feldsher-midwifery post GDP gross domestic product Hib Haemophilus influenzae type B IDU intravenous drug user NRA National Regulatory Agency OPV oral polio vaccine SES Sanitary Epidemiological Station TB tuberculosis tD ? TEIg tick-borne encephalitis immuno-globulin UNICEF United Nations Children’s Fund VII Vaccine Independence Initiative WHO World Health Organization Introduction

Purpose

This report, which was prepared under the Asian Vaccination Initiative, assesses the current and future financing needs of the national immunization programs of Kazakhstan and the Kyrgyz Republic.

The assessment was made to assist the Governments of those countries in planning future program investments by providing an analysis of the following: • Economic, political, and demographic background of each country and the health context within which its immunization program is operating • Structure and performance of the immunization program, including: – coverage – immunization laws and regulations coherent analysis of – management capacity – vaccine procurement and supply Afinancial requirements, – service delivery – surveillance systems available resources, and – quality assurance • Costs and future financing requirements of the immunization program financing gaps is an A coherent analysis of financial requirements, available resources, and financing gaps is important aspect of medium- an important aspect of medium-term planning and, therefore, program sustainability. term planning and, therefore, Methodology program sustainability The information and data for this report were collected between October and December 2000. An international consultant spent two weeks each in Kazakhstan and the Kyrgyz Republic and collaborated with a national consultant in each country for the assessments. In Kazakhstan, the consultants interviewed representatives of the Agency for Healthcare, Ministry of Finance, Ministry of Economy, republican and subnational Sanitary Epidemio- logical Stations (SESs), United Nations Children’s Fund (UNICEF), and World Health Organization (WHO) in the cities of Astana and Almaty and the oblasts of Karaganda and Kozylorda. In the Kyrgyz Republic, they interviewed representatives of the Ministry of Health, Ministry of Finance, republican and subnational SESs, UNICEF, and WHO. A list of the people interviewed is in Appendix 1.

Overview

Before they gained independence from the , Kazakhstan and the Kyrgyz Republic had health systems that were based on a highly centralized and command- driven model. This system provided very high coverage but was financially unsustainable because it depended (as did the entire economy) on large subsidies from Russia. The viii

transition to a market-based economy, and the withdrawal of this budget support, there- fore led to a dramatic decline in health spending in absolute terms. However, in relative terms health spending was largely maintained at about 10 percent of total Government spending in Kazakhstan and 11 percent in the Kyrgyz Republic.

Predictably, health services suffered when there were less financial resources. Immuniza- tion programs were not exempt: a drop in vaccination coverage rates opened the door to vaccine-preventable disease. In the early 1990s a diphtheria epidemic swept the newly independent states.

Kazakhstan and the Kyrgyz Republic undertook to reform the health sector in the process of political and economic change. Health systems were largely decentralized, and author- azakhstan and the ity and responsibility for program implementation passed to the provincial (oblast) governments. However, responsibility for policy development, supervision, and monitor- Kyrgyz Republic ing of vertical national programs such as immunization remained with national Govern- K ment agencies or institutions. undertook to reform the By 1998 both countries were recovering from economic crisis. Gross domestic product health sector in the process (GDP) in Kazakhstan was growing at a rate of 1.7 percent and per capita GDP was $1,468, up from $741 in 1994. The Kyrgyz Republic, on the other hand, had a GDP growth rate of political and economic of 6 percent and per capita GDP of $2,140, from $1,712 four years earlier. Their immu- nization programs improved, with significant support from the Japanese Government and change. Health systems were UNICEF, and coverage rates returned to over 90 percent. largely decentralized, and However, the parallel experiences of the two countries in the matter of independence, economic transition and recovery, and structural health reform did not extend to their authority and responsibility approach to the financing of their national immunization programs. Kazakhstan, by 2000, had achieved self-sufficiency in Expanded Program on Immunization (EPI) vac- for program implementation cines ($925,214 in 2000) and will assume full financial responsibility for all routine childhood vaccines, including hepatitis B, in 2001. In contrast, the Kyrgyz Republic, by passed to the provincial 2000, had committed only 8 percent ($24,000) of the total sum required and will depend heavily on donors over the next five years, not least because of the introduction of (oblast) governments Hib vaccine. The difference in financial sustainability outlook between the two countries could not be more stark.

At the same time, the two programs show similar shortcomings in operating, and there- fore financial, efficiency. Above all, vaccine procurement strategies need to be developed, vaccine wastage analyzed and reduced, and cold-chain equipment and management strengthened. Addressing these issues will help to maximize the use of limited resources, promote financial sustainability, and, hence, give rise to more robust and consistent programs.

In summary, Kazakhstan and the Kyrgyz Republic have immunization programs with parallel histories and structures. They also face the same future challenge: that of strength- ening their programs and consolidating recent gains while introducing and financing new vaccines with extremely limited resources. But given the contrasting approaches they have taken so far to financial support and program sustainability, their responses to the challenge—and the results they achieve—will expectedly be different.

Kazakhstan CHAPTER I Summary

Kazakhstan enters the new millennium with cause for cautious optimism about the viability and sustainability of its immunization program.

Although, vaccination coverage rates dropped significantly in the early 1990s, they have recovered strongly since the mid-1990s and are now greater than 95 percent. Conse- quently, vaccine-preventable diseases among children are largely under control.

Since 1995 the Government of Kazakhstan, in partnership with UNICEF and the Gov- ernment of Japan, has become increasingly self-sufficient in funding essential child- hood vaccines. While it has experienced difficulties complying with the agreed payment schedules, the Government has demonstrated its commitment to the principle of self- he primary indicator sufficiency. for the continued A Presidential Decree issued in 1998 stated confidently, in the context of major reforms T in government and the health sector, that there would be: • A coordinated national program to achieve full immunization of children up to 5 years development of a national old • A hepatitis B program for all infants, and hepatitis A and hepatitis B programs for immunization program is selected at-risk groups • Full immunization coverage of newborns political commitment in the • Adequate financing for all the foregoing form of strong advocacy The primary indicator for the continued development of a national immunization pro- gram is political commitment in the form of strong advocacy and funding support. In and funding support 2001, the Government will assume full financial responsibility for funding routine child- hood immunization. Although the proposed budget should be sufficient for this purpose, some key issues in program delivery and quality brought out in the present assessment must be attended to if recent improvements in the immunization program are to be sustained. Some of these issues can be addressed in the next Vaccine Independence Initiative (VII) agreement, which is to be renegotiated at the end of 2000. These issues include: • A strategy for the procurement of vaccines and injection and cold-chain equipment • A replacement as well as a repair and maintenance plan for cold-chain equipment • Needs assessment, with a view to upgrading the National Regulatory Agency so that it can fulfill all four functions recommended for vaccine-importing countries • A strategy for reducing vaccine wastage, including a cost-benefit analysis of varying- dose vials and improved stock control • A national measles campaign for all school-age children • A hepatitis A vaccination program following an assessment of the epidemiology of the disease and the development of a planned control strategy for populations that are most at risk CHAPTER II Background

Kazakhstan is an independent republic on the central Asian steppe, with a geographic area of 2.7 million square kilometers. It borders Russia to the north, the People’s Republic of to the east, and the Kyrgyz Republic, , and Turkmenistan to the south. In 1999 Kazakhstan had a population of about 14.9 million.

The country is ethnically diverse. Kazakhs (52 percent), Russians (31 percent), Ukraini- ans (4 percent), and Germans (2 percent) are the major ethnic groups, and Kazakh and Russian are the official state languages. The main religions are Sunni Muslim and Russian Orthodox, though the people are reported to be mostly atheists. Kazakhstan was the last ncreasing poverty since Soviet republic to declare independence, in December 1991.

independence has lowered Kazakhstan is a unitary state with a presidential form of government. The country is I divided into 14 oblasts and 220 districts (rayons). Oblast governors (akims) are ap- the major human development pointed by the president and are the chief decision makers on the healthcare system. Local councils (maslihat) have been elected since 1994, under a form of local democ- indicators—average life racy, but their decisions can be overriden by the oblast. expectancy, adult literacy and Socioeconomic Indicators educational attainment, and Increasing poverty since independence has lowered the major human development indi- per capita GDP—in the 1990s. cators—average life expectancy, adult literacy and educational attainment, and per capita GDP—in the 1990s. Thirty percent to 50 percent live below the poverty line. Thirty percent to 50 percent The economy was in severe recession in the first half of the 1990s and has recovered live below the poverty line slowly since then. Inflation rates worsened when the tenge replaced the Russian ruble in 1993 but began to improve in 1996. Real wages in 1996 were about one-third of what they were in 1991. The registered unemployment rate of about 4 percent in 1997 does not reflect actual unemployment because of the restrictive criteria and the reluctance of the unemployed to register.

Government expenditure as a percentage of GDP declined from 31 percent in 1990 to 19 percent in 1996, as shown in Table 1. The impact on the public sector was height- ened by a corresponding decline in GDP growth and falling Government revenue from income and corporate taxes. In recent times, the economy has shown modest GDP growth but further expansion is expected, driven primarily by industry and natural resource development.

Health sector expenditure

Several factors combined during the 1990s to cause a major drop in Government spend- ing (including health). These factors included the GDP collapse, high inflation, the ending of subsidies from Moscow, and tax collection difficulties. With the healthcare budget shrinking between 1992 and 1995, the healthcare system was barely maintained. 6

Table 1: Macroeconomic Indicators, 1990–1998

Indicator 1990 1991 1992 1993 1994 1995 1996 1997 1998 GDP growth rate (% change) -0.04 -13.0 -2.9 -10.4 -17.8 -8.9 1.1 2.0 1.7 Per capita GDP (US$) - - 1,684 1,445 741.4 982.1 1,316 1,415 1,468 Per capita GDP (PPP $) 4,716 4,490 4,270 3,710 3,284 - 2,296 - - Annual inflation rate (%) - 191 1,615 1,758 1,977 276 22 12 7 Government expenditure as % of GDP 31.4 32.9 31.8 25.2 25.9 20.7 18.5 27.7 21.8 Real wage index (1991=100) - 100 64.8 49.1 32.9 33.4 34.4 - - Registered unemployment rate - 0.1 0.9 0.6 1.1 2.1 4.1 3.8 -

Source: WHO Regional Office for Europe, Health for All database; UNICEF, TransMONEE database 3.0; Economist Intelligence Unit

The proportion of GDP allocated to health began at a low level in the 1990s, declined further in the mid-1990s, and began to recover in 1998.

The health budget has stayed at around 10 percent of the total budget in most years, as shown in Table 2.

Table 2: Trends in Healthcare Expenditure, 1991–1998

Healthcare Expenditure 1991 1992 1993 1994 1995 1996 1997 1998 Value in current prices (million ruble, 1991–1993; million tenge, 1994–1998) 3,127 24,260 601,092 7,699 23,447 31,503 46,100 63,000 Value in constant prices (million ruble, 1991–1993; million tenge, 1994–1998) - - - 389 8495 14319 38417 - Value in constant prices per capita (PPP $) 203 86 86 56 ---- GDP share (%) 4.4 2.1 2.5 2.0 2.0 2.7 3.2 3.5 Share of Government budget (%) 10 7 11 10 13 14 9 -

Source: WHO Regional Office for Europe, Health for All database; UNICEF, TransMONEE database 3.0

Demographic and Health Indicators

The population has decreased over the past decade, from 16.7 million in 1990 to about 14.9 million in 1999 (see Table 3), and is projected to decrease further (projected annual growth rate: –0.6 percent) as a result of emigration and a slowing birth rate (from 23.1 births per 1,000 in 1989 to 14.4 in 1999). Measured in terms of the number of women of reproductive age, the decline in total births is equal to a drop in the fertility rate from 2.7 births per female in 1991 to only 2 births per female in 1999.

About 30 percent of the population is below 15 years of age. The proportion of the population living in urban areas versus rural has remained stable over the last decade. In 1999, 55.7 percent lived in urban areas, and 44.3 percent in rural areas. Kazakhs were the major ethnic group in oblasts, and Russians and other ethnic subgroups were pre- dominantly concentrated in cities and towns.

The unfavorable demographics of the country are further aggravated by the growth in the general mortality rate (from 8.2 per 1,000 in 1991 to 10.2 in 1999). One factor associ- ated with this trend has been a large increase in the male mortality rate. Infectious and parasitic diseases, accidents, and respiratory and cardiovascular diseases have been the main causes of mortality among males. 7

Table 3: Demographic Indicators, 1989–1999

Indicator 1989 1990 1991 1992 1993 1994 1995 1996 1997 1999 Population (million) 16.5 16.7 17.0 17.1 16.9 16.6 16.5 15.9 15.8 14.9 % of population under 15 years 21.8 31.5 31.3 31.1 30.9 30.7 30.1 29.8 29.5 Crude death rate per 1,000 population 7.6 7.7 8.0 8.1 9.1 9.5 10.2 10.4 10.2 Live births per 1,000 population 23.1 21.8 20.9 19.8 18.7 18.5 16.7 15.9 14.8 Total fertility rate 2.9 2.7 - 2.5 2.3 - 2.3 2.0 2.0

Source: WHO Regional Office for Europe, Health for All database; UNICEF, TransMONEE database 3.0

Among females, a major health risk is the high number of abortions. Despite a decline of 36 percent over the past five years, abortions still number about 170,000 yearly. On average, each woman of childbearing age has two abortions. Teenage abortions have declined in number but the rates have not fallen. Between 1990 and 1997, life expectancy at birth fell from 63.9 to 59.4 years for males, and from 73.4 to 70.6 years for females (see Table 4).

Table 4: Health Indicators, 1990–1998

Indicator 1990 1991 1992 1993 1994 1995 1996 1997 1998 Female life expectancy at birth 73.4 73.1 73 71.6 71.1 70.4 70.3 70.6 70.4 Male life expectancy at birth 63.9 63.7 63.6 61 60.5 59.3 58.9 59.4 59 SDR ischemic heart disease (0–64 [?]) per 100,000 males 143 143 150 178 187 215 220 207 - TB incidence per 100,000 population (all forms) 65.8 64.4 64.4 60.9 62.4 67.1 87.6 91.4 120.6 Infant mortality rate per 1,000 live births 26.7 27.6 26.3 28.8 27.4 27.9 25.9 25.3 24 Under-5 mortality rate per 1,000 age group 34.9 35.6 34.2 38.1 36.2 38.4 35.2 - - Maternal mortality per 100,000 live births 54.8 48 56.9 49.6 48.3 57.4 52.9 59 - Abortions per 100 live births 70.2 74.8 102 91.9 85.4 80.9 76.7 67.4 -

Source: WHO Regional Office for Europe, Health for All database; UNICEF, TransMONEE database 3.0

Mortality from all main causes has been declining since 1994. However, against this trend, mortality rates from infectious diseases, particularly TB, diphtheria, hepatitis, and AIDS, have been growing. The incidence of tuberculosis per 100,000 population was 91.4 in 1997, compared with an average of 67.4 in the newly independent states.

Infant mortality in 1997, at 25.3 deaths per 1,000 live births, was over four times the 5.7 average in the European Union. However, as premature births and low-birth-weight babies who died within seven days are still not included in Kazakhstan’s definition of infant mortality, actual rates (according to the international definition) could be higher. The mortality rate for the under-5 age group was 35.2 in 1996, five times the EU average. The major causes of death in this age group are respiratory diseases, diarrhea, and injury.

Vaccine-preventable diseases

The overall incidence of vaccine-preventable diseases has shown a general downward trend during the last decade. However, epidemics of certain diseases have occurred as routine vaccination coverage has declined, population mobility increased, and the economy worsened in the early- to mid-1990s. 8

As in several other former Soviet countries, an epidemic of diphtheria began in 1993 and lasted for six years. It peaked in 1995, when 1,105 cases were reported, for an incidence rate of 6.91 cases per 100,000 population. Following several years of improved vaccination coverage and an intensive diphtheria vaccination schedule (seven doses by 16 years of age), the rate has declined significantly to 0.11 per 100,000. In 1999 there were 17 cases reported, 10 of these in children below 14 years old.

A large measles outbreak occurred in 1993 and 1994, with annual incidence rates of 19.35 and 11.19 per 100,000, respectively, and almost 8,000 cases over the two-year period. These periodic outbreaks of measles in Kazakhstan reflect a common phenom- enon of measles epidemiology, where the accumulation of a susceptible population over time approaches the equivalent size of the birth cohort, the critical mass for a large epidemic. This usually takes three to five years in a country with measles vaccination coverage of around 90 percent. In addition, the age distribution of cases moves further into older children, adolescents, and eventually adults.

There was a major outbreak of measles among high school students in 1998. This epidemiology supports the move to introduce a second routine dose of measles vaccine into the schedule in 1995. However, until a major catchup campaign for adolescents and adults occurs, Kazakhstan can expect further periodic epidemics primarily in these age he overall incidence of groups. Following a meeting on regional measles elimination in Bishkek in 1999, Kazakhstan has committed to pursuing the goals of measles control by 2003 and measles elimination Tvaccine-preventable by 2007. diseases has shown a general A significant achievement in public health in Kazakhstan has been the control and elimi- nation of indigenous poliomyelitis. The last significant reported outbreak occurred in downward trend during the 1988–1989, with 13 cases in 1989. The last indigenous case reported was in 1995, and an imported case was reported in 1999. According to WHO, Kazakhstan qualifies to be last decade. However, certified as polio-free, as part of regional certification. epidemics of certain diseases Mumps has continued to occur sporadically, with 5,500 cases reported in 1998 and 2,900 in 1999. Relative to other vaccine-preventable diseases, mumps is not associated have occurred as routine with high mortality rates. However, it is a component of the routine schedule and has therefore not been well controlled, with a single dose of mumps vaccine at 12 months of vaccination coverage has age in the current schedule. The epidemiology of mumps and the potential costs and benefits of introducing a second dose at 6–7 years should be investigated further. declined, population mobility There were 4,000 cases of hepatitis B reported in 1998 and 3,000 cases in 1999. increased, and the economy Transmission and risk of infection are both vertical (maternal) and horizontal (IDU, sexual). Routine hepatitis B vaccination for infants was funded by the Government and worsened in the early- to introduced in 1998, and there is also a program for vaccinating healthcare workers. mid-1990s Hepatitis A continues to cause major epidemics, particularly in the southern regions. Almost 35,000 cases were reported in 1998, resulting in the introduction of a hepatitis A vaccination program in the most affected communities. The total disease incidence was halved by 1999, when 12,500 cases were reported. The epidemic is said to have declined further in 2000. It should be noted, however, that twice as many children below 14 years of age were affected compared with adults. 9

Almost 20,000 cases of tuberculosis were reported in 1999, 32.6 percent more than in 1998. Although it is suggested that case ascertainment has improved in recent years, the incidence rate has climbed steadily, from 91.4 in 1997 to 131.4 in 1999. Adults and the elderly are the most affected; however, the extremely high prevalence of he rural and urban areas tuberculosis in the community makes the vaccination of all neonates and infants even more imperative. TB treatment and control is understandably a major priority Tdiffer in healthcare in Kazakhstan. delivery. In the rural areas, Pertussis and tetanus are currently both well controlled. The last major outbreak of pertussis was in 1992, and the annual incidence rate has declined over the past decade, feldsher posts, rural physician from a peak of 6.61 per 1,000 in 1992 to 0.37 per 1,000 in 1999. clinics, and small rural Although not part of the routine immunization schedule, influenza (flu) vaccination is provided to at-risk children and the elderly. Almost 130,000 cases of influenza were hospitals provide primary reported in 1998, and 170,000 in 1999. No data on the disease burden or vaccine efficacy are available as yet, but the Agency for Healthcare intends to expand the influenza care. In the urban areas, program as resources permit. The vaccine is available to the public. primary and secondary care is Health System obtained in polyclinics, basic Structure secondary care in rayon The Agency for Healthcare, formerly known as the Committee of Health, is at the top of the hospitals, more specialized health system hierarchy and has overall control of the federal health system. At the republican level, the main functions of the Agency are to formulate policy, prepare care in oblast or city hospitals, legislation, commission research, develop reform strategies, monitor the health of the population, supervise the implementation of reforms, and ensure the training of health and tertiary care in national personnel. It also exercises broad supervision over national hospitals and research insti- tutes, and monitors public and environmental health through the Sanitary Epidemiologi- specialist institutes cal Service.

Health services, however, are administered mainly by oblast health departments (via hospitals and polyclinics), which have considerable autonomy in running services in their area (see Figure 1). The rural and urban areas differ in healthcare delivery. In the rural areas, feldsher posts, rural physician clinics, and small rural hospitals provide primary care. In the urban areas, primary and secondary care is obtained in polyclinics, basic secondary care in rayon hospitals, more specialized care in oblast or city hospitals, and tertiary care in national specialist institutes. This delivery system is being reorganized so that primary care will eventually be delivered by family physician clinics; as a conse- quence, many small hospitals have been closed.

Some healthcare organizations (hospitals, large polyclinics, and primary care groups) are now legally able to manage their own affairs as jurisdictional enterprises. The oblasts decide which organizations can move to this arrangement and which should continue to be run and funded by the State. Some ministries and government agencies run their own network of health services. These represent a significant share of the healthcare system (about 7 percent). 10

Figure 1: Organization of Healthcare System

Ministry of Ministry of Health, Other Finance Education, and Sport ministries

Medical Service Agency for Education Payment Center Healthcare Committee

Republic hospitals Republic Medical Oblast and research centers SES universities offices

Oblast/City departments Parallel health Oblast/City Oblast/City services facilities SES

Chief physician, Rayon Rayon central rayon hospital facilities SES

Rural Feldsher Rural physician hospitals posts clinics

An extensive system of Sanitary Epidemiological Stations (SESs) with a successful record in controlling communicable diseases has been developed. In 1998 there were 57 SESs throughout the country. The largest stations have laboratory capacities and perform bacteriology services for hospitals. SES physicians are trained in their own medical facili- ties, which also conduct national-level research and monitoring. In recent times, how- ever, staffing has been cut, and many laboratories are in poor condition with outdated equipment and a shortage of necessary materials.

The SESs, in conjunction with rayon health departments, are responsible for immuniza- tion programs nationwide.

Finance

The Agency for Healthcare also has responsibility for preparing the healthcare budget and controlling the allocation of the Republican portion. The healthcare system overall has remained severely underfunded, receiving only one-third of its requested budget in some years. The Ministry of Finance allocates funds to the Agency for Healthcare. The Ministry of Finance also has oblast-level administrations, which allocate locally raised revenue to oblast-level health departments. There is considerable variation in revenue across oblasts. CHAPTER III National Immunization Program

Immunization Schedule

Kazakhstan provides routine immunization against eight diseases to children and adults, according to the schedule in Table 5.

Table 5: Routine Immunization Schedule, 2000

Age at Immunization Disease 0–4 days 2 mos 3 mos 4 mos 12 mos 18 mos 6–7 yrs 12 yrs 16–17 yrs Every 10 yrs TB (BCG) X X Poliomyelitis X X X X Tetanus X X X X X X Diphtheria X X X X X X X X Pertussis X X X X Hepatitis B X X X Measles X X Mumps X

Organizational Structure

The immunization delivery structure reflects the vertical hierarchy of SESs shown in Figure 1. The Republican SES is responsible for immunization scheduling, policy setting, vac- cine procurement and distribution, national surveillance of vaccine-preventable diseases, blast and rayon SESs are and surveillance of vaccination coverage and adverse effects following immunization (AEFI). Injection equipment for children up to 2 years old is also procured at the primarily responsible for national level. The major decision-making body in the Republican SES is the O Immunoprophylaxis Committee. service delivery including Oblast and rayon SESs are primarily responsible for service delivery including ensuring the ensuring the adequate adequate provision of vaccines and injection equipment, staffing, adherence to the cold chain, and registration of children for clinical services. provision of vaccines and injection equipment, staffing, Legislative Framework adherence to the cold chain, The regulation of immunobiologicals in Kazakhstan is supervised by the Pharmacology State Committee (PSC), which is composed of four commissions: Immunobiologicals, and registration of children for Drugs, Food and Additives, and Curative Cosmetics. clinical services The PSC acts as the National Drug and Immunobiologicals Regulatory Authority (NRA). The PSC and the Immunobiologicals Commission are headed by a chairman and are assisted by the same Scientific Secretary. In 1998, a proposed decree defining the role, duties, and authority of the Immunobiologicals Commission was submitted. 12

All staff working in the Immunobiologicals Commission are seconded from the Agency for Healthcare. The Commission meets at the Pharmacology State Institute and its records are stored at the Laboratory of Allergology, the PSC, and the Daridarmek State Company (which is responsible for licensing).

Kazakhstan has no criteria for recognizing other NRAs, and the PSC does not ask NRAs abroad to verify data received from manufacturers.

Licensing

The PSC has delegated the authority to manage licensing and registration to the Daridarmek State Company. The licensing is based on written and published guidelines, which list the documents that the manufacturer is required to submit to obtain a license. However, there are no guidelines for the NRA review process.

The Immunobiologicals Commission convenes expert committees when needed to re- view product information submitted by manufacturers. The registration fee for each outine vaccination product is $3,000, and licenses are granted for a maximum of five years.1 Rcoverage has historically been high in Kazakhstan. Surveillance of vaccine performance The AEFI surveillance system is supervised by the national Immunoprophylaxis Commit- However, in 1993 it began to tee and is supposed to involve NRA expertise. The system is enforced by a decree issued by the Ministry of Health in 1998. The decree outlines the reporting process and lists the decrease because of irregular events to be reported. The Agency and the NRA meet regularly to review data. vaccine procurement, which led to supply shortages Lot release Each lot of vaccines arrives with a summary lot protocol; however, lot documents are not certified.

Laboratory access

Two laboratories perform some vaccine testing. A special commission is in charge of laboratory quality systems, but there is no real budget for improving facilities, equipment, or staff training. The tests performed in these laboratories are also not subjected to data trend analysis.

1 The main requirements for a product licensing dossier are: good manufacturing practice (GMP) certificate; retail certificate; documentation of certification of registration in country of origin and other countries if certified; product quality certificates and test certificates; summary report with expert evaluation; chemical evaluation; chemical, pharmaceutical, and biological documentation; composition of the preparation; control of initial, intermediate, and final products; stability data; toxicological and pharmacological documentation; clinical documentation; use of instructions in the original language and . 13

Facilities

The NRA is located in the National Institute of Hygiene and Epidemiology. The laboratory facilities are in the Plague Research Institute and the National Institute. Registration and licensing files are spread among a former state company, which has now been privatized, the Pharmacology State Committee, Daridarmek State Company, and the Immunobiologicals Commission.

Vaccination Coverage

Figure 2: Vaccination Coverage by 12 Months of Routine vaccination coverage has historically been high in Kazakhstan. However, in 1993 Age, 1991–1999 it began to decrease because of irregular vaccine procurement, which led to supply % shortages (see Figure 2). The Demographic and Health Survey carried out in 1995 100 provided an in-depth analysis of immunization coverage. According to the survey, cover- 80 age dropped significantly between the first and third doses of DPT and polio vaccine in rural areas compared with urban areas. The southern region was also disproportionately 60 affected. For example, DPT coverage dropped from 96 percent to 74 percent in Almaty 40 City, and from 97 percent to 37 percent in south Kazakhstan.

20 In 1995, the Vaccine Independence Initiative (VII) was established in Kazakhstan (see “Vaccine Supply” in the next section). With an assured procurement mechanism in place, 0 , , , , , , , , , 91 92 93 94 95 96 97 98 99 national coverage increased and has been maintained at over 90 percent for the last five BCG DPT3 OPV3 Measles years. CHAPTER IV Future Financing

There is no identified budget line for EPI in general or for any program subcomponent such as vaccines, injection equipment, or cold chain.

Key Issues

Vaccine supply

There are currently two procurement streams for vaccines in Kazakhstan: the Vaccine Independence Initiative (VII) for EPI vaccines used for children below 2 years, and a ssentially, the Vaccine tender process for private supply. EIndependence Initiative Forecasting was established to increase Oblast SESs are required to submit vaccine estimates to the Republican SES every year. Usage and wastage rates are monitored monthly, enabling review estimates to be compiled the capacity of middle- before the supply tender for the following year is drafted. Monthly distribution lists are drafted at the oblast level and forwarded to the Republican SES for approval. The distri- income countries to finance bution orders are also checked by the Customs Agency before the release of the next quarter’s stock is approved. the procurement of vaccines The system for monitoring the denominator population (and hence vaccine needs) for their national appears to be effective. Each newborn is given a personally held record before discharge from the hospital. This also enables the recording of birth doses given in the hospital. The immunization program maternity hospital forwards the birth details to the relevant polyclinic and the child and its parents are registered for their vaccination schedule. Polyclinics will follow up with parents to ensure compliance. Polyclinics also conduct a twice-yearly census of all chil- dren in their locality to ensure their records are accurate and to account for mobile populations.

Vaccine Independence Initiative (VII)

In 1994 UNICEF, in cooperation with the Government of Japan and the Governments of Kazakhstan, Turkmenistan, and Uzbekistan, initiated a set of agreements called the Vac- cine Independence Initiative (VII) projects. These projects consisted of a formal agree- ment between the national government, the Japanese Government, and UNICEF. Funds needed for EPI vaccines were provided in various shares by each party, with the majority share shifting from the external donors to the national government over five years. A key element of the agreements was that all funds provided by the national government had to be in hard currency.

Essentially, the VII was established to increase the capacity of middle-income countries to finance the procurement of vaccines for their national immunization program. This was expected to facilitate the redirection of donor funds from routine EPI vaccines to new 16

antigens and new technologies: sustainable financing of traditional EPI vaccines would allow countries to introduce new vaccines without disrupting their supply of basic vaccines.

Kazakhstan signed the initial VII agreement in November 1994. The agreement outlined the financial contributions of the Government of Japan, UNICEF, and the Government of Kazakhstan, and was for a period of six years, from 1995 to 2000. The payment schedule defined an increasing proportional contribution by the Government of Kazakhstan, so that by 2000 it would assume full financial responsibility for national vaccine procure- ment and distribution (see Table 6). Under the agreement, UNICEF procures EPI vaccines from its central store in Copenhagen and the Government of Kazakhstan is responsible for reception, customs clearance, and distribution of all VII-related vaccines.

Table 6: VII Cost Sharing, 1995–2000 (US$)

1995 1996 1997 1998 1999 2000 Total Government of Japan 500,000 400,000 350,000 250,000 199,000 0 1,699,000 UNICEF 50,000 100,000 75,000 0 0 0 225,000 Government of Kazakhstan 20,593 127,516 265,704 515,074 638,639 925,214 2,492,740 % of total contribution 4% 20% 38% 67% 76% 100% Total Cost of Vaccines 570,593 627,516 690,704 765,074 837,639 925,214 4,275,641

Note: Vaccine costs exclude handling charges

Until 1998, the funds for the contribution of the Government of Kazakhstan to the VII came from the national budget and were allocated to the fund by the Ministry of Finance. In 1999 the responsibility for the transfer of funds was shifted to the Ministry of Foreign Affairs. The VII payment structure was based on an assumed annual population growth of 0.8 percent and an annual vaccine price increase of 8 percent. However, as the actual rates fell short of both assumptions, a surplus of funds has resulted. This surplus is being used for injection and cold-chain procurement (see “Cold Chain” and “Injection Safety” below).

Non-VII vaccines

The Government of Kazakhstan is responsible for the procurement of vaccines for older children and adults, including vaccines not on the routine immunization schedule but necessary for certain at-risk groups, such as rabies, typhoid, and influenza vaccines. In addition, since 1998, the Government has procured hepatitis B vaccine for infants. All of these vaccines are procured using a tender process managed by the Immunoprophylaxis Committee. The Committee takes into consideration both technical and commercial con- tent, including documentation requirements, storage and distribution capacity, compliance with WHO vaccine specifications, vaccine registration with the Government, and prices.

The results of the tender are forwarded to the Ministry of Finance, as purchase orders placed with the successful agency or agencies are disbursed under an approved Ministry of Finance schedule.

For 2000, the Government had vaccine procurement contracts with three companies: Albeda, Medical Services Plus, and Chance Limited. The terms of the contracts require 17

each company to be responsible for importation, customs clearance, storage, and distri- bution down to the oblast storage level.

Overall, the vaccines procured by each agency are as follows: • UNICEF: BCG, DTP, measles, OPV, hepatitis B • Albeda: DT, Td, diphtheria monovalent, hepatitis B • Medical Services Plus: Hepatitis B, mumps, measles • Chance Limited: Influenza

Importation

Once procured, both VII and non-VII vaccines must be cleared through customs. As mentioned previously, the responsibility for customs clearance of non-VII vaccines rests with the procurement agency. However, the clearance of UNICEF-supplied vaccines is the responsibility of the Government, and this process has been problematic.

Although a recent Government memorandum stated that “goods imported to Kazakhstan bought by budget organizations at the expense of the state budget are released from taxation,” there continue to be delays in the clearance of UNICEF vaccines. In the most notable example, measles vaccine that was to be used in a planned campaign was delayed for weeks in customs. The barriers are: • Financial, as there is no budget line for import duties • Bureaucratic, as neither the Agency for Healthcare nor UNICEF accepts responsibility lthough a recent for customs clearance. UNICEF is explicit in its view that this is a Government problem, Government which must be solved by the relevant Government agencies. But the Agency for Healthcare A believes that UNICEF should bear the responsibility and cost for customs clearance of VII vaccines. UNICEF has, in the past, bypassed the customs requirement by delivering memorandum stated that vaccines as “humanitarian aid.” “goods imported to Costs and financing Kazakhstan bought by budget Government funding for vaccine procurement has a defined line budget, facilitating organizations at the expense the tracking and accounting of expenditure. For 2001, the Government will fund all vaccine purchases, and has allocated $3,148,659. This amount covers VII vaccines, a of the state budget are hepatitis B program for all infants, and other vaccines including immunoglobulins. released from taxation,” there Table 7 outlines the vaccine requirement for the recommended immunization schedule for children from birth to 6 years. A general level of vaccine wastage of 20 percent is used continue to be delays in the to calculate the requirement. As discussed later, this is lower than the currently accepted level of 30 percent program-wide. clearance of UNICEF vaccines This cost of estimated requirements, when compared against the amount allocated for procurement, reflects possible overspending of $485,000. Taking into consideration addi- tional costs of handling and distribution (about 20 percent of vaccine costs, according to the Agency for Healthcare), net savings of $363,000 could be made. The savings can be realized by paying closer attention to stock estimation and reducing unnecessary wastage.

Nonchildhood vaccines are expected to cost around $600,000, as shown in Table 8. 18

Table 7: Comparison of Vaccine Procurement and Estimated Requirements (cost in US$)

Total Doses Procured Total Doses Required Vaccine Source Cost per Dose (2001) Cost to the Government (+ 20% waste) Surplus/(Deficit) BCG UNICEF 0.064 1,095,000 70,080 520,800 367,488 DTP UNICEF 0.088 1,188,400 104,580 1,041,600 12,918 Measles UNICEF 0.132 699,000 92,268 300,000 52,668 OPV UNICEF 0.085 1,188,400 101,014 1,041,600 12,478 Mumps MSP 0.460 250,000 100,000 260,400 (4,000) Hepatitis B #1 UNICEF 0.565 400,000 226,000 781,200 67,122 Hepatitis B #2 MSP 1.750 500,000 875,000 67,122 DT Albeda 0.190 250,000 47,500 327,600 (23,256) Total 1,816,442 485,418

Note: Based on 100% coverage and 20% wastage. The above figures do not include additional hepatitis A or hepatitis B vaccine for adolescent/adult programs (pending the release of final data on actual volumes). The Government is planning to expand both these programs to at-risk populations, contingent on the availability of funds.

Table 8: Costs Associated with Adolescent and Adult Vaccines (cost in US$)

Vaccine Source Cost per Dose No. of Doses Cost to Government Td Albeda 0.09 500,000 45,000 D Albeda 0.10 250,000 25,000 Rabies vaccine Albeda 3.40 50,000 170,000 Enteric vaccine Albeda 0.08 500,000 40,000 TE Ig Albeda 9.20 8,500 78,200 Typhoid Albeda 2.10 36,000 75,600 DAT Albeda 6.00 200 1,200 Tuberculin Albeda 127.38 (per lt) 240 30,571 Tuleraemia Albeda 0.10 19,000 1,900 Anthrax Albeda 1.06 4,000 4,240 Influenza Chance 3.50 30,000 105,000 Rabies Ig Albeda 1,273.88 (per lt) 20 25,477 Total 602,188

Vaccine distribution

Until recently, the largest national storage facility based in Almaty was Government- owned. Albeda, being the largest private distributor, rented storage space from the Gov- ernment. In an unofficial reciprocal arrangement, it distributed vaccines provided by UNICEF. Albeda has now taken over the ownership of the central storage facility.

Vaccines are dispersed quarterly from Almaty to oblast and city storage facilities by rail and air. From there, the vaccines are distributed to rayon SESs or city polyclinics either quarterly or monthly depending on the storage capacity at the lower level, and subse- quently to rayon polyclinics or mobile vaccination clinics. Figure 3 gives an overview of the national distribution system.

Cold chain

The cold-chain system in Kazakhstan has suffered over the past two decades from a lack of investment in replacement and maintenance, particularly in freezing capacity for the 19

Figure 3: Overview of Vaccine Distribution

UNICEF Albeda Medical Services Plus Chance Ltd

Annual tender Quarterly distribution approval Republican National Storage SES Almaty

Oblast/City SESs Quarterly distribution Monthly distribution

Rayon SESs City polyclinics Monthly distribution As required

Rayon polyclinics Mobile polyclinics

preparation of cold boxes for the nationwide distribution of vaccines. Kazakhstan was not among the countries that benefited from a joint initiative of the Government of Japan and the United States Agency for International Development in 1992–1993 to rehabilitate the cold-chain infrastructure in Central Asia.

In 1996, international donors and the Government developed a project to upgrade the cold-chain system, the priority being the strengthening of the central storage capacity in Almaty and the establishment of a subnational storage capacity in Astana, Actobe, Kzylorda, and east Kazakhstan (Semipalatinsk). The project had a budget of $400,000. The Gov- ernment contributed 30 percent and international donors provided the balance.

Costs and financing

The allocation of funds for the maintenance of cold-chain equipment cannot be assessed for lack of data. There is no budget line for this, either at the national level or in oblasts or rayons.

Although no complete audit of the country’s cold-chain needs has been made, the Agency for Healthcare estimates the cost of a one-off upgrade of national cold-chain equipment (excluding regional storage and freezing equipment, and transport and handling costs) at about $840,000, as shown in Table 9. This amount includes 5,750 thermo-containers (2,000 of these have been purchased in the past two years) and 102,000 ice-box vaccine carriers. The status of the existing stock of such vaccine carriers has not been determined.

Both UNICEF and the Government of Kazakhstan have indicated they will continue to progressively replace substandard cold-chain equipment, pending the availability of funds. However, the replacement program is not well planned in terms of projected needs and required funds. 20

Table 9: Estimated Cost of Upgrading National Cold-Chain Equipment (cost in US$)

Item No. Unit Cost Total Cost Freezers 12 800.00 9,640 MK40 refrigerators 344 1451.00 499,144 Refrigerators 45 1390.00 62,550 Cold packs, 20-liter 80 345.00 27,600 Thermo-containers, 3-liter 5,700 15.44 88,008 Thermo-containers, 27-liter 50 180.00 9,000 Vehicle (vaccine transport) 1 20,000.00 20,000 Voltage stabilizers for refrigerators 50 100.00 5,000 Ice-box carriers 102,000 0.70 71,400 Maintenance 50,000.00 50,000 Total 842,342

Note: Based on UNICEF contract prices

Injection safety

National policy calls for the use of sterile disposable equipment in all vaccinations. Officially, oblast and rayon health administrations are responsible for providing injection equipment for children over 2 years old. Supplies are purchased locally together with other general medical supplies, so resources specific to the various types of immuniza- tions cannot be identified.

Before the VII agreement and following the interruption in trade links with suppliers from the former USSR, there was no assured supply of disposable syringes. However, in 1997 the Government requested UNICEF to start procuring disposable syringes with excess Government funds, within the VII. This system has been able to meet the needs for the primary vaccination schedule, including the introduction of the hepatitis B program for infants. As with UNICEF-procured vaccines, injection equipment procured under the VII must also be cleared through customs, and there have been delays in supply and distribution.

There are no available data on waste disposal needs or system performance. SES officers interviewed said that inappropriate disposal leading to safety concerns was not an issue; however, this matter should be investigated.

Interviewees supported the use of auto-disable syringes, but they believed that dispos- able syringes were not being reused and that no market pressures existed for such reuse, despite supply shortages in some oblasts due to delays in customs clearance. (While admitting that supply shortages have led parents to buy syringes from local retailers, interviewees maintained that these were isolated cases and that syringes were not reused.)

Costs and financing

For 2001, Kazakhstan proposes to procure through UNICEF 2.5 million BCG syringes and 4.5 million syringes for use with other vaccines. Assuming a birth cohort of 21

217,000 and population-based estimates of older cohorts, this volume of injection equipment is enough to cover all required vaccinations recommended on the immu- nization schedule from birth to 16 years of age (about 4 million), even with a wastage factor of 5 percent.

Based on UNICEF prices plus 15 percent transport fee and 7 percent handling cost, it will cost about $86,000 to supply injection equipment to the delivery point. This figure could be reduced significantly (by 40 percent) if supply were more closely aligned to needs.

Injection safety boxes will also be procured through the VII. For 2001 Kazakhstan proposes to procure 1,500 five-liter, 475 ten-liter, and 40 twenty-liter safety containers. Procurement, transport, and handling will cost about $2,000.

If adjustments are made in the projected vaccine order to realize savings (see “Vaccine Supply” above), enough funds will be available to supply the country’s injection equip- ment needs.

Adverse effects following immunization (AEFI)

Over the period 1995 to 1997, Kazakhstan had two significant clusters of AEFI. The first occurred in mid-1995 following measles vaccination. Seven children experienced a reaction several hours after vaccination, and three children died. In the following year, five children in three separate oblasts developed AEFI following the administration of DTP vaccine and four subsequently died.

here are no available data UNICEF, in conjunction with WHO and the Ministry of Health, investigated the incidents to determine the causes. Malpractice in the preparation of the lyophilized measles vac- on waste disposal needs cine was reported as the probable cause of the first cluster. No explanation for the second T cluster was available. or system performance. SES It was also found that the serious AEFI cases admitted to hospital had been poorly officers interviewed said that managed and that inadequate protocols had been implemented for their treatment. UNICEF and WHO have since provided technical and financial support for several work- inappropriate disposal leading shops on AEFI reporting and management. to safety concerns was not an Disease control initiatives issue; however, this matter As part of the immunization program the Government may undertake a national measles should be investigated campaign for all school-age children, of which there are about 3 million.

Costs and financing

Such a campaign would cost almost $6 million, as shown in Table 10. No sources of funding have been identified. 22

Table 10: Cost of Measles Campaign (US$)

Item Amount Vaccine 3,960,000 AD injection equipment 150,000 Supply, transport, handling 800,000 Social mobilization 900,000 Total 5,810,000

Financing Needs, Sources, and Gaps

In general, given the overall level of Government funding for the basic program and the actual need, there should be enough funds for the procurement and supply of vaccine and injection equipment.

Savings realized through more accurate forecasting of needs and minimized customs and import duties, for example, would provide enough surplus to undertake a short- to medium-term schedule for the replacement of substandard cold-chain equipment.

n general, given the National and subnational expenditures for program support (personnel, surveillance, laboratory support, training, and social mobilization) are not readily available. In all overall level of instances, they are indistinguishable from other health service delivery costs, even within I the SES system. Government funding for The major areas requiring external support relate to strengthening support system func- the basic program and tions. This will require a secondary level of assessment in those areas where data, re- sources, and Government support are lacking. the actual need, there In the context of the key policy issues and recommendations outlined in sections 6 should be enough funds and 7 of this report, financial support is required to develop and implement the following: for the procurement 1. A procurement strategy for vaccines and injection and cold-chain equipment 2. A replacement, maintenance, and repair schedule for cold-chain equipment and supply of vaccine 3. Needs assessment for upgrading the National Regulatory Agency so that it is able to fulfill all four recommended functions of vaccine-importing countries and injection equipment 4. A vaccine wastage reduction strategy, including a cost-benefit analysis of using smaller- dose and single-dose vials, and improved stock control 5. A hepatitis A vaccination program, contingent on the results of a review of hepatitis A epidemiology and the development of a planned control strategy in populations most at risk. (At this time there are not enough data to assess the impact of a routine vaccination program for all children versus the costs and benefits of a targeted cam- paign for other at-risk groups.) CHAPTER V Policy Options

Program Management

Having the support and the means to continually improve and develop the immunization program will lead to successful outcomes only if the entire system is competently man- aged. Despite vast change during the last decade, the immunization program is well placed to perform strongly, but requires a reconstitution of its management and advisory structures. Political decision makers must be able to see that the health gains to be achieved through effective financial and technical administration justify investing in the immunization program.

he Agency for Healthcare Vaccine Procurement does not have enough T The long-term objective for Kazakhstan should be to have the capacity and options to procure all vaccines and cold-chain and injection equipment at a competitive price expertise to maximize the without having to resort to the UNICEF supply mechanism. purchasing power of its In the meantime, to maximize sustainable financing for the program, the Government should consider restructuring the schedule for the new VII agreement. Reducing the available funds beyond what schedule for paying Government funds into the VII from quarterly to twice a year, or preferably a single payment, would lessen the risk of arrears resulting from other UNICEF currently offers. This Government budgetary pressures (as they did during the term of the first VII agree- ment). It would also further demonstrate the Government’s commitment to the VII shortcoming will become process. increasingly important as The Government failed to provide regular funding for non-VII vaccines in 1999. This was a result of (i) a downward revision in the national budget at the start of the fiscal year, and UNICEF’s role changes over (ii) the effects of deficit funding, through which the Government allocates revenues from the first quarter of the current year to close deficits in the previous year. Stocks of vaccines time left over from 1998 were used to meet some requirements of the schedule in 1999. These unstable funding conditions result in over-ordering and overstocking for contingencies, increasing wastage and placing further pressure on the vaccine budget.

The VII may offer a procurement process, but it is not a procurement strategy, and a comprehensive procurement strategy is needed as a priority. The Agency for Healthcare does not have enough expertise to maximize the purchasing power of its available funds beyond what UNICEF currently offers. This shortcoming will become increasingly impor- tant as UNICEF’s role changes over time. The other major need is a procurement strategy that is broad enough to consider all nonvaccine resources as well, and the means for financing them.

While Kazakhstan has, in the past, procured injection equipment and cold-chain items through the VII mechanism, it has done so largely in an ad hoc fashion, to use unspent reserves. A specific budget line for sourcing through the VII nonvaccine supplies for 24

children up to 7 years old would facilitate forecasting of needs and continuity of funding, and minimize such disruptions.

Vaccine Wastage

Vaccine wastage is an area of potential savings. The currently accepted national wastage rate of 30 percent should be reduced. A realistic target would be a reduction of 10 percent over the life of the next VII agreement. Besides looking into the wasteful practice of hoarding, caused by historically inconsistent funding, the Government should review wastage levels in general, because the move away from large polyclinics to smaller family physician practices calls for such streamlining. An assessment of vaccine wastage should n assessment of vaccine include a cost-benefit analysis of the use of varying-dose vials, especially for more expen- sive vaccines, and the implementation of greater accountability for stock control at oblast Awastage should include a and rayon levels. cost-benefit analysis of the use National Regulatory Agency of varying-dose vials, especially While the financing of vaccines is important in sustaining vaccine procurement, a fully for more expensive vaccines, functioning National Regulatory Agency is essential to program quality. This is particularly important in the long term, as close scrutiny will have to be exercised in introducing new, and the implementation of more expensive vaccines to ensure their efficacy and safe use in new populations. An investment in strengthening the NRA is well justified. greater accountability for stock control at oblast and rayon New Vaccines levels The Government is considering introducing Hib and rubella vaccine into the routine program. The capacity to introduce new vaccines would indicate a sustainable immuni- zation program, but the Government must first resolve two policy issues. These are: • There are no available data on the total disease burden for either Hib or rubella. Therefore, the cost-effectiveness of the vaccine in Kazakhstan has not been determined. (The Government should seek technical support from WHO or the Centers for Disease Control in Atlanta in undertaking cost-effectiveness studies for both rubella and Hib disease.) • The current level of Government financing for vaccines would not permit the introduc- tion of these vaccines in the short term.

Similarly, cost-effectiveness must be considered in broadening the hepatitis A vaccination program. While hepatitis A infection still causes significant epidemics, vaccination strat- egies to date have depended on the availability of funds. CHAPTER VI Recommendations

It is recommended that, in the context of the renegotiation of the VII agreement (set for late 2000) and future program development, the Government of Kazakhstan should:

1. Strengthen the management structure of the National Immunization Pro- gram by: (a) Reviewing the structure of the republican Immunoprophylaxis Committee and its role in overseeing the performance of the national immunization program. (b) Developing a reconstituted peak committee with senior technical and administra- tive representation. The committee should meet regularly to review the medical, technical, programmatic, and financial aspects of the immunization system and the control of vaccine-preventable diseases.

he Government of 2. Maximize the value of the new VII agreement by: (a) Increasing the age limit from 2 years to 7 years. Kazakhstan should (b) Holding immediate dialogue among the Agency for Healthcare, Customs Agency, T and UNICEF to resolve financial and procedural barriers to customs clearance, in strengthen the management recognition of the Government’s responsibility for clearance issues, under the VII agreement. structure of the National (c) Restructuring the payment schedule for the VII agreement by reducing the schedule for the payment of Government funds into the VII from quarterly to twice Immunization Program by a year, or preferably a single payment. (d) Procuring nonvaccine supplies for children up to 7 years old through the VII, reviewing the structure of and specifying a line item for nonvaccine expenditures in the agreement. (e) Developing a medium- to long-term procurement strategy by: the republican (i) Developing, during the next VII, a comprehensive procurement strategy that considers options beyond 2005. The current competitive tendering process Immunoprophylaxis for non-VII vaccines has not been subjected to a full audit to determine its ability to provide the most cost-effective access to vaccines in the international Committee and its role in market. (ii) Considering registration and licensing requirements and their impact on overseeing the performance competitive tendering under the plan. of the national 3. Improve the procurement of non-VII vaccines by: (a) Ensuring that all vaccines outside the VII agreement are procured from WHO- immunization program prequalified manufacturers, at least until the National Regulatory Agency becomes fully functioning. (b) Developing and implementing a procurement strategy. (c) Ensuring the regular flow of funds for non-VII vaccines by establishing a line item in the annual budget for all vaccines.

4. Implement a strategy for reducing vaccine wastage.

5. Strengthen the functions of the National Regulatory Agency by working with WHO to develop all four recommended regulatory functions for countries importing vaccines. 26

6. Strengthen cold-chain management and ensure effective distribution of equip- ment by developing and implementing a plan for the replacement, maintenance, and repair of cold-chain requirements.

7. Demonstrate its commitment to eliminating measles by: (a) Defining disease control objectives to help focus the capacity of surveillance, immunization, laboratory, and outbreak response systems (for example, in line with the gains made in polio eradication). (b) Capitalizing on the introduction of an additional dose in the routine measles vaccination schedule by developing an elimination plan that outlines the re- sources and technical elements required to stop the indigenous transmission of wild measles and effectively respond to imported cases. (c) Funding and undertaking a national measles catchup and mop-up campaign among all school-age children who have not routinely received a second dose of measles vaccine.

It is further recommended that the Government: 8. Undertake cost-effectiveness studies on: (a) Introducing new vaccines (Hib/rubella) (b) Broadening the hepatitis A vaccination program

Kyrgyz Republic CHAPTER VII Summary

Between 1994 and 2000, the Kyrgyz Republic made significant advances in its national immunization program. Major achievements included: high coverage rates for EPI vac- cines (97–98 percent); rationalization of the vaccination schedule; the creation and operation of the Inter-Agency Coordination Committee on Immunization; and the estab- lishment of the Center for Immunoprophylaxis, which now administers the program, within the Ministry of Health.

The scope of program activities can be broadened through the introduction of new vaccines and the elimination of target diseases. However, core elements of the program must first be strengthened. Areas that need attention include: he revised immunization • General access to immunization services by the population, as a public good • Program funding, and protection from financial risk Tplan for 2001–2005 • Program monitoring and evaluation, to improve quality and outcomes • Undergraduate and postgraduate education in immunoprophylaxis outlines a comprehensive set • Social mobilization at all levels of the population • Use of global and regional experience to maximize the resources available to the of strategies for achieving immunization program disease control and program The revised immunization plan for 2001–2005 outlines a comprehensive set of strategies for achieving disease control and program quality objectives. Before the ultimate goal of quality objectives a sustainable immunization program can be realized, however, a number of areas must be addressed. These include: • Assurance of continuity in vaccine procurement • Strengthening of the National Regulatory Agency • Strengthening of the cold chain, which currently has significant deficits in the quality of refrigeration, storage, and transportation equipment and adherence to cold-chain policies • Strengthening of injection safety practices, with major improvements in the disposal of sharps and waste • Optimization of demand for, and access to, immunization services • Acquisition of financial resources for a national measles and rubella mass vaccination campaign, planned for 2001

Overall, funding needs associated with nonvaccine items are the largest risk to the Kyrgyz national immunization program. CHAPTER VIII Background

The Kyrgyz Republic is a republic in central Asia, which gained independence in August 1991. It is a small, mountainous country with a geographic area of 199,000 square kilometers bordering Kazakhstan to the north, the People’s Republic of China to the east, he Kyrgyz economy Uzbekistan to the west, and Tajikistan to the south.

suffered badly after the The ethnic groups represented in the country are the Kyrgyz (the largest group, at about T 61 percent of the population of more than 4.5 million), Russians (15 percent), Uzbeks collapse of the former USSR, (14 percent), and minority groups including Ukrainians and Germans. The official languages are Kyrgyz and Russian. The main religion is Sunni Muslim, but there are on which the country had Russian Orthodox and Roman Catholic minorities. In 1997, 62 percent of the population lived in the rural areas and 38 percent in the urban areas. depended for its export The Kyrgyz Republic’s presidential style of government was consolidated in 1996, five market and substantial budget years after the country joined the Commonwealth of Independent States and elected its first president. The country is divided into seven oblasts and each oblast has several towns subsidies and districts (rayons). There are 64 towns or rayons in all. The capital, Bishkek, is a separate administrative region. Each region is headed by a governor (akims) and has an elected oblast council (oblast kenesh).

Socioeconomic Indicators

The Kyrgyz economy suffered badly after the collapse of the former USSR, on which the country had depended for its export market and substantial budget subsidies. A dramatic fall in economic activity was accompanied by very high inflation rates. GDP contracted by 50 percent between 1992 and 1995 (it dropped by 20 percent in 1994), as shown in Table 11. In 1998 GDP grew by only about 2 percent, because of declining gold produc- tion, lower-than-expected agricultural output, and financial turmoil in the Russian Fed- eration.

Table 11: Macroeconomic Indicators, 1990–1997

Indicators 1990 1991 1992 1993 1994 1995 1996 1997 GDP growth rate (% change) 3.0 –5.0 –19.0 –16.0 –20.0 1.3 5.6 6.0 Per capita GDP (US$) - 1,550 810 850 610 690 - - Per capita GDP (PPP $) 3,520 3,239 2,776 2,328 1,712 1,880 1,745 2,140 Annual inflation rate (%) - 113 1 359 1 086 181 43 32 23 Government expenditure as % of GDP 38.3 30.3 33.9 39.1 28.6 30.2 23.4 22.3 Real wage index (1994=100) - - - - 100 112 114 126 Registered unemployment rate - 0.01 0.10 0.20 0.70 2.90 4.40 3.10

Source: WHO Regional Office for Europe, Health for All database; UNICEF, TransMONEE database 3.0

Despite this, the Kyrgyz Republic has become one of the most progressive countries of the former Soviet Union in carrying out market reforms. A stabilization program it has been 32

undertaking since 1994 has had a significant impact, dramatically lowering inflation from 181 percent in 1994 to 23 percent in 1997. Foreign assistance has played a substantial role in the country’s economic turnaround, but at the cost of a high foreign debt burden.

However, poverty and income inequalities in the Kyrgyz Republic have increased substan- tially during the political and economic transition. Real wages declined before steadying in 1997, with the number of households living in poverty rising sharply from 45 percent in 1993 to 71 percent in 1997. Adult literacy levels are high but, given the indicators for average life expectancy and educational attainment, the country is at the mid level of human development and is below average for transition economies.

Health sector expenditure

Comprehensive and accurate data on health expenditure are not available; information on private health spending is difficult to obtain. But there are available data on Govern- ment health expenditure (since 1995) and official user fee revenues (since 1996). In addition, the Mandatory Health Insurance Fund has data since its inception in 1997.

Government healthcare expenditure in the 1990s fluctuated between 3 percent and 4 percent of GDP, as shown in Table 12. In line with the Health Sector Reform Project, which strove to sustain the health system, the Government had to maintain its contribu- tions at the real (inflation-adjusted) 1994 rate, and not reduce them by using revenues from the Mandatory Health Insurance Fund or other fees. As a result, the health budget has stayed, on average, at around 12 percent of the total Government budget.

Table 12: Trends in Government Healthcare Expenditure, 1990–1998 (million som)

Healthcare Expenditure 1990 1991 1992 1993 1994 1995 1996 1997 1998 Value in current prices (million som) 1.6 2.8 21.3 137.4 418.3 639.7 744.6 9.4.1 1043.1 Value in constant prices (1990) (million som) 1.8 1.4 1.0 0.7 0.8 - - - - Share of GDP (%) 3.7 3.0 2.8 2.6 3.5 3.9 3.1 2.9 2.9 Share of Gov’t budget (%) - 13.1 8.8 11.5 14.2 12.9 14.0 13.7 11.6

Source: Ministry of Health, Bishkek; World Bank (1996); Kutzin (1999)

Demographic and Health Indicators

Emigration after independence has kept the population relatively stable at 4.5 million. Despite a high birth rate it grew only 2.7 percent between 1990 and 1997 (see Table 13). If the high fertility rate (3.4 births per woman aged 15–44 years) is maintained, growth will continue. The results of the 1999 census will provide more concrete information.

Around 37 percent of the population is below 15 years of age. The number of live births per 1,000 population still far outnumbers the number of deaths (28.6 deaths per 1,000 live births in 1997), although the figure would be higher if international definitions for infant mortality were applied. 33

Table 13: Demographic Indicators, 1989–1997

Indicator 1989 1990 1991 1992 1993 1994 1995 1996 1997 Population (million) 4.3 4.4 4.4 4.5 4.5 4.4 4.5 4.5 4.5 % of population under 15 years 37.5 37.6 37.6 37.7 37.8 37.9 37.7 37.5 36.9 Crude death rate per 1,000 population 7.3 7.0 6.9 7.2 7.8 8.4 8.2 7.6 7.5 Live births per 1,000 population 30.6 29.5 29.3 28.8 26.3 24.8 26.2 23.8 22.2 Total fertility rate 3.8 - 3.7 3.1 3.6 3.1 3.3 3.0 2.8

Source: WHO Regional Office for Europe, Health for All database; UNICEF, TransMONEE database 3.0

Although maternal mortality improved during the 1990s, in 1997 it rose to 62.7 deaths per 100,000 live births, twice the rate of mortality in the former USSR and almost ten times the mortality of this demographic group in the European Union. Infant mortality rate is high (28.6 per 100,000 in 1997), and there is no sign of rates decreasing although the major causes of death in this age group (respiratory diseases, diarrhea, and injury) are largely preventable.

Noncommunicable diseases have risen sharply, as in most countries of the former USSR, partly as a result of a high-fat diet, smoking, alcohol abuse, and other forms of unhealthy behavior. Men are particularly affected.

Some communicable diseases, including those associated with poverty, have returned. High rates are reported for pulmonary tuberculosis and the disease exacts a high mortality rate (see Table 14). Rates of diphtheria and hepatitis have also increased. The incidence of syphilis and other sexually transmitted diseases began to rise in the 1990s.

Table 14: Health Indicators, 1990–1997

Indicators 1990 1991 1992 1993 1994 1995 1996 1997 Female life expectancy at birth 73.0 72.7 72.2 71.1 69.9 69.9 71.0 71.2 Male life expectancy at birth 64.4 64.6 64.2 62.5 61.1 61.3 62.5 62.5 SDR ischemic heart disease (0-64) per 100,000 males 103 104 109 135 158 152 153 136 TB incidence per 100,000 population (all forms) 52.9 56.9 57.9 54.5 61.4 75.4 90.1 114.0 Infant mortality rate (per 1,000 live births) 30.2 29.7 31.6 32.9 29.6 27.7 26.6 28.6 Maternal mortality (per 100,000 live births) 62.9 55.6 49.9 44.5 42.7 44.3 31.5 62.7 Abortions per 100 live births 41.6 37.7 34.2 31.9 28.5 23.1 22.4 21.2

Source: WHO Regional Office for Europe, Health for All database; UNICEF, TransMONEE database 3.0

Vaccine-preventable diseases

The overall incidence of vaccine-preventable diseases has shown a general downward trend during the last decade. However, a decline in routine vaccination coverage, high rates of population mobility, and falling economic conditions in the early- to mid-1990s have resulted in a number of epidemics.

As with other former Soviet countries, an epidemic of diphtheria began in 1993 and, lasted for six years, resulting in around 1,850 reported cases. The epidemic peaked in 34

1995, with an incidence rate of 15.7 per 100,000. This rate declined to 2.3 per 100,000 in 1999 because of improved vaccination coverage and an intensive diphtheria vaccina- tion schedule (seven doses by 16 years of age).

Measles has historically had a very high incidence in the Kyrgyz Republic. In 1960, the reported incidence was over 1,500 per 100,000. But routine vaccination of 1-year-old children, which began in 1968, has led to a steady reduction. Cyclical epidemics have, however, continued to occur every three years or so, and these have affected increasing proportions of school-age children. A second routine dose of measles vaccine, given at 6 years of age, was therefore introduced in 1986. In the 11-year period after 1968, the mortality rate for measles under the two-dose schedule was over 3000 percent less than the rate under the one-dose schedule (48 deaths versus 1,445). During this same period, however, the proportion of deaths from measles in children below 1 year old doubled.

A significant achievement in public health has been the control and elimination of indigenous poliomyelitis. The last significant reported outbreak occurred in 1993, as did the last indigenous case. According to WHO, the Kyrgyz Republic qualifies to be certified as polio-free, as part of regional certification.

Mumps is part of the routine vaccination schedule but has not been well controlled with the current schedule of a single dose of vaccine at 18 months. The disease is now endemic in the easles has historically Kyrgyz Republic. Almost 5,000 cases were reported in 1996, and 1,800 cases in 1999. had a very high In a cycle of three-year epidemics, rubella reached a high of 3,200 reported cases in M 1992, declined to less than 200 cases in 1994, and then reemerged to another peak incidence in the Kyrgyz incidence of 1,700 cases in 1997. There are also anecdotal reports of parallel increases in the incidence of congenital rubella infection coinciding with maternal infection during Republic. In 1960, the these outbreaks. In an attempt to eliminate congenital rubella infection, the Kyrgyz Republic intends to include rubella vaccination in combination with measles vaccine in reported incidence was over both mass vaccination campaigns in 2001 and to introduce routine two-dose rubella vaccination at 12 months and 6 years of age in 2003. 1,500 per 100,000. But The incidence of tuberculosis is rapidly increasing. In 1997 it reached 114 per 100,000, routine vaccination of 1-year- almost double the rate of disease (67.4 per 100,000) in the newly independent states. old children, which began in Pertussis is currently well controlled. The last significant outbreak of pertussis was reported in 1992. The annual incidence rate for pertussis has declined over the past 1968, has led to a steady decade, from a peak of 9.3 per 100,000 in 1992 to 1.4 per 100,000 in 1999. reduction Health System

Structure

After independence in 1991, healthcare reform was included on the Kyrgyz policy agenda but remained a lower priority than economic reform. The Ministry of Health (MOH) nonetheless embarked on a program of change. Many international and other agencies assisted in this period of transition, and have continued to influence health sector reform. 35

The health system of the Kyrgyz Republic remains fragmented among the four levels of government: rayon, municipality, oblast, and republican. Overlaps in the population served have led to duplicate funding and healthcare provision.

The MOH has a policymaking and supervisory role and administers the health facilities of the Republic. Health services, however, are administered in a decentralized fashion, mainly by oblast departments, which have considerable autonomy in running services in their area (see Figure 4).

Figure 4: Organization of Healthcare System

Parliament President

Cabinet of ministers

Ministry of Ministry of Finance Health

Oblast kenesh National hospitals Mandatory Health National centers Insurance Fund National research institutes Republican diagnostic center Republic center for immunization Oblast/City Medical information center administration Republican health center - finance - health

Oblast hospitals SESs Dispensaries City hospitals and polyclinics Central rayon hospitals

The MOH supervises the activities of all health-related institutions and approves their policy and program documents. Professional associations, including the Association of Physicians and Pharmacists and professional nursing associations, currently have little influence on policymaking decisions. However, two new associations established in 1997, the Family Group Practice Association and the Hospital Association, are working closely with the MOH.

Parallel health services are also in place and provide health services directly to the employees of some ministries, including the Ministry of Internal Affairs, Ministry of Defense, and Ministry of National Security. In 1998, parallel health services accounted for around 6 percent of the total Government healthcare expenditure. 36

Regional administrations (oblast and city) are responsible for administering most pri- mary and secondary health care, including polyclinics and regional and district hospitals, and for implementing health plans prepared at the national level. However, the regulatory authority exists only to monitor the Mandatory Health Insurance Fund (discussed below), and not the implementation of health plans within the oblasts.

The head of each oblast health department is appointed with the approval of the Minister of Health. The oblast health departments were abolished in January 2000 and replaced by committees, but this management structure is still being developed.

Nongovernment organizations are also evolving and are active in maternal and child health, family planning, and sexual health education.

The delivery system is being reorganized. In rural areas feldsher posts, rural physician clinics, and small rural hospitals now provide primary care, and in urban areas polyclin- ics give primary and secondary care. Primary care will eventually be delivered by family group practices, which include adult and pediatric physicians, obstetricians/gynecolo- gists, and several nurses. Plans call for these family group practices to extend throughout the country by 2001.

An extensive system of Sanitary Epidemiological Stations (SESs) with a successful record in controlling communicable diseases has been developed. In 1998 there were 57 SESs throughout the country. The largest SESs have laboratory capacities and perform bacteri- he health system of the ology services for hospitals. SES physicians are trained in their own medical facilities, Kyrgyz Republic remains which also conduct national-level research and monitoring. In recent times, however, T staffing has been cut and many laboratories are in poor condition with outdated equip- ment and a shortage of necessary materials. The SESs, in conjunction with rayon health fragmented among the four departments, are responsible for immunization programs nationwide. levels of government: rayon, municipality, oblast, and Finance The Ministry of Finance is responsible for preparing the healthcare budget and control- republican. Overlaps in the ling the allocation of funding to all healthcare facilities. State taxation is the main source population served have led of funding for the health system. The Mandatory Health Insurance Fund operates by collecting payroll contributions from to duplicate funding and employees equal to 2 percent of salaries. These funds contributed around 4.3 percent of Government spending in 1998. Private (voluntary) health insurance schemes exist to healthcare provision offer support for specialist services.

External donations have greatly assisted the health budget. Health projects, including those set up to purchase pharmaceuticals and medical equipment, have been financed, or aided via donations, by a number of bilateral and multilateral organizations. However, the Ministry of Finance does not record or monitor the total amount of external funds received, some of which bypass the Government authority and go directly to the oblast health administrations. CHAPTER IX National Immunization Program

National Immunization Plan

A revised national plan for 2001–2005 has been recently approved. This plan builds on the gains made in the previous five years, and reinforces the priority given to expanding the routine vaccination schedule and improving program quality.

he revised national plan The priorities for the immunization program over the next five years are: • Reducing the incidence of pertussis to less than 2 per 100,000, and diphtheria to 0.2 for 2001–2005 builds on per 100,000 T • Preventing the outbreak of epidemics and further decreasing epidemic mumps mor- the gains made in the previous bidity to single cases • Decreasing the measles morbidity rate to less than 1 per 100,000, preventing out- five years, and reinforces the breaks, and eliminating measles by 2007 • Reducing hepatitis B cases among children below 5 years old to single cases priority given to expanding the • Preventing the emergence of local cases of poliomyelitis caused by wild strains of poliovirus, and implementing activities to prevent importation routine vaccination schedule • Reducing the occurrence of suppurative meningitis and pneumonia caused by Haemophilus influenzae type B (Hib) and improving program quality • Decreasing the incidence of rubella, preventing neonatal tetanus, and decreasing the number of cases of disseminated TB and TB meningitis forms among 1-year-olds

To achieve these goals, the following strategies are planned: • Ensure adequate and guaranteed funding for vaccine procurement and protection from finance risk by incrementally increasing Government expenditure within the Vaccine Independence Initiative from $36,000 in 2001 to $84,000 in 2005 • Ensure universal access to immunization, and maintain a coverage level of 95–98 percent • Introduce vaccines against Hib infection and rubella • Implement targeted programs for hepatitis B and measles • Immunize newborns, teenagers, and medical staff against hepatitis B • Develop a single computer network, including a national database on each child vaccinated, the vaccine provider, and details of vaccine-preventable infections and morbidity • Provide the Republic with high-quality immunobiologicals and drugs by: – Establishing quality monitoring by the Agency for Immunobiological Drugs – Meeting and maintaining the requirements of the cold chain and providing oblast, city, and rayon SESs with autonomous power (electricity) sources – Improving epidemiology and surveillance of vaccine-preventable disease – Conducting research on Hib and rubella infection – Improving pre- and post-diploma education and training of physicians and nurses pertaining to immunization – Conducting social mobilization of the population using public and social organi- zations and the mass media 38

The Republic routinely immunizes children and adults against eight diseases. The na- tional immunization schedule is shown in Table 15.

Table 15: Schedule of Immunization in the Kyrgyz Republic

Age at Immunization Disease Birth 4 days 2 mos 3.5 mos 5 mos 12 mos 16 mos 18 mos 6–7 yrs 11 yrs 16 yrs Every 10 yrs TB (BCG) X X Poliomyelitis X X X X X X X DPT X X X X (to 24 mos) DT X tD XXX X Hepatitis B X X X Measles X X Mumps X

Source: Report on Immunization Practice (Health Facility) in Weeks (1996b) and draft parent-held immunization card prepared by FGP association Note: Doses in shaded boxes are funded by UNICEF

Organizational Structure

In December 1993 the MOH organized a planning exercise involving WHO, UNICEF, and USAID. It resulted in a plan for a National Program for Immunoprophylaxis (NPI) 1994– 2000. This plan included the creation of the Republican Center for Immunoprophylaxis (RCI) as a unit within the Republican SES, and the establishment of Oblast Centers for Immunoprophylaxis (OCIs).

Overall administration and implementation of the immunization program at the Repub- lican level is the responsibility of the First Deputy Minister for Health Care and the Chief Sanitary Physician of the Kyrgyz Republic. The Republican SES, through the RCI, manages the functions of national policy development, national surveillance of vaccine-prevent- able diseases, surveillance of vaccination coverage and adverse effects following immuni- zation, and technical supervision of disease prevention and outbreak management. It is also responsible for immunization scheduling and the procurement and distribution of vaccines and injection equipment for children below 2 years old. The major decision- making body in the Republican SES is the Committee for Immunoprophylaxis.

Below the national level, the chief sanitary physicians of the oblasts, rayons, and cities, as well as the Immunization Centers of the various SESs and the heads of Family Group Practices, supervise program implementation. This function includes ensuring the ad- equate provision of vaccines and injection equipment, staffing, adherence to cold-chain protocols, and the registration of children for clinical services.

The structure for the delivery of immunization services reflects the vertical hierarchy of the SESs, previously outlined in Figure 4. There are 4,500 service delivery centers.

A main activity under the healthcare restructuring program has been to strengthen and develop primary health care, represented by Family Group Practitioners (FGPs). As a result, immunization, as one of the elements of primary prevention, has been maintained 39

and enhanced during the restructuring process. The Government provides practitioners with basic medicine, equipment, instruments, and medical literature. A system of finan- cial incentives is being developed to ensure maximum patient access and service quality.

The main immunization activities of FGPs are: • Taking a full audit of both children and adults enrolled in the FGP • Maintaining accurate records of immunization histories • Keeping close watch over vaccination activities and maintaining records of adverse reactions to vaccination • Accurately recording and reporting immunization coverage • Observing all cold-chain requirements during the storage and transportation of vac- cines

Vaccination planning by FGPs is based on a computer database of the population served. Figure 5: Vaccination Coverage by 12 Months of An annual immunization plan is developed each October. Age, 1990–1999

% Physicians and immunologists assist FGPs on immunization-specific issues. All vaccina- 100 tions are given by trained staff in FGPs and Family Medicine Centers. 80 60 Vaccination Coverage 40 The incidence of vaccine-preventable disease shows that immunization has been effective 20 in the Kyrgyz Republic (see Figure 5). No cases of poliomyelitis, an endemic disease for decades, have been reported since 1993. Other successes of the immunization program 0 , , , , , , , , , , 90 91 92 93 94 95 96 97 98 99 include the control of epidemic diphtheria and a dramatic decrease in measles cases BCG DPT3 OPV3 Measles Mumps reported since 1980. CHAPTER X Future Financing

Key Issues

Vaccine supply

The supply of vaccines needed for the EPI has been a concern since the country gained he supply of vaccines independence. Up to 1991, virtually all vaccines used in the Kyrgyz Republic were pro- needed for the EPI has duced in the Russian Federation. Since then, new requirements for hard currency trans- T fers, changes in the procedure of payment by Russian vaccine manufacturers, rapid increases in the prices of Russian vaccines, and overall reductions in MOH resources have been a concern since the caused problems in vaccine supply. country gained independence. UNICEF, with the financial support of the Japanese Government, supplied EPI vaccine needs for 1995–1998. In 1999, with the support of the Japanese Government ending, Up to 1991, virtually all UNICEF provided EPI vaccines using its own financial resources and the assistance of vaccines used in the Kyrgyz donors (United Kingdom and Canadian Governments). In 2000, the Kyrgyz Government began assuming increased responsibility for financing Republic were produced in vaccines for routine childhood immunization, through an arrangement similar to the the Russian Federation UNICEF Vaccine Independence Initiative. There is a plan to introduce measles, mumps, rubella (MMR) vaccine in 2003.

In light of the positive experiences of neighboring countries with the Vaccine Indepen- dence Initiative, the Kyrgyz Government now seeks to develop a similar project. In 2000, the Government committed to pay 8 percent of the financial requirement for the purchase of the primary series of vaccine for children up to 2 years of age. Over the next five years (2000–2004), the Government will increase this level of financial contribu- tion by 4 percent each year to achieve 24 percent self-financing of vaccines and syringes by the year 2004, as shown in Table 16. The additional funds needed to meet yearly financial requirements will be provided with multi-bilateral support from the Japanese Government. UNICEF will be responsible for the delivery of vaccines to the country. The Government, for its part, will be responsible for customs and excise clearance of consignments.

Table 16: Summary of VII Vaccine Cost-Sharing Agreement, 2000–2005 (US$)

2000 2001 2002 2003 2004 2005 Total Government of Japan 276,000 264,000 252,000 240,000 228,000 0 1,260,000 Government of Kyrgyz Republic 24,000 36,000 48,000 60,000 72,000 84,000 324,000 % of total contribution 8% 12% 16% 20% 24% 28% Total required annually 300,000 300,000 300,000 300,000 300,000 300,000 1,800,000 Gap (potential donor) 0 0 0 0 0 216,000 216,000

Note: Pertains to vaccines for children up to 2 years old. Vaccine costs exclude handling charges 42

The Kyrgyz Government will create a national budget line to allocate funds and will transfer the funds to UNICEF in hard currency. UNICEF will procure vaccines on behalf of the Government. The Government will benefit from UNICEF contract prices as well as the WHO/UNICEF quality assurance scheme, which performs certain functions that would normally be carried out by a National Control Authority.

Technical assistance will be provided for the establishment of a National Regulatory Agency, which will gradually take over the responsibility for quality control of imported vaccines in compliance with WHO standards, and the establishment of effective proce- dures for the purchase of the vaccine through international bidding.

Each year the MOH and UNICEF will review immunization coverage and vaccine stock n 2000, the Kyrgyz levels to estimate the quantity of the necessary vaccines to be ordered. The level of Government began implementation of the cold-chain upgrading will also be reviewed every year and addi- I tional equipment will be ordered accordingly. assuming increased responsibility for financing Vaccine distribution Vaccine distribution is centralized. The Republican SES releases vaccines quarterly to vaccines for routine oblast and city storage facilities. From this level, distribution to rayon SESs or city polyclin- ics occurs either quarterly or monthly depending on storage capacity. The vaccines are childhood immunization, subsequently distributed to rayon polyclinics or mobile vaccination clinics (see Figure 6). through an arrangement Oblast SESs are responsible for submitting vaccine estimates to the Republican SES. Usage and wastage rates are monitored monthly, enabling review estimates to be compiled similar to the UNICEF Vaccine before the following order through UNICEF is drafted. Independence Initiative Figure 6: Overview of Vaccine Distribution

UNICEF

Republican National SES Storage

Oblast/City SESs

Monthly usage reporting Quarterly distribution

Quarterly Monthly distribution distribution

Rayon SESs City polyclinics Monthly As required distribution

Rayon Mobile polyclinics polyclinics 43

Costs and financing

Vaccines for both the primary and revaccination schedule will cost $41.4 million over the next five years, as shown in Table 17. This amount includes all vaccines on the recom- mended routine immunization schedule and in the proposed hepatitis B, Hib, and MMR programs.

Table 17: Cost Estimates for Vaccines, 2001–2005 (US$)

Item 2001 2002 2003 2004 2005 Total DPT Vaccine 93,150 93,150 93,150 93,150 93,150 465,750 Revaccination 31,050 31,050 31,050 31,050 31,050 155,250 OPV Vaccine 44,160 44,160 44,160 44,160 44,160 220,800 Revaccination 11,040 11,040 11,040 11,040 11,040 55,200 BCG Vaccine 43,700 43,700 43,700 43,700 43,700 218,500 Hepatitis B Vaccine 957,894 766,316 766,316 691,020 691,020 3,872,566 Measles Vaccine 138,000 138,000 276,000 Revaccination 79,200 79,200 79,200 79,200 79,200 396,000 Outbreak response 65,160 65,160 65,160 65,160 65,160 325,800 Mumps Vaccine 86,620 90,280 176,900 Outbreak response 25,986 27,084 28,000 30,000 30,840 141,910 ADT Revaccination 24,800 25,600 26,240 27,040 27,872 131,552 Outbreak response 7,440 7,680 8,000 8,112 8,368 39,600 ADT-M Revaccination 85,540 88,200 91,000 93,800 96,600 455,140 Outbreak response 25620 26,460 27,300 28,140 28,980 136,500 MMR Vaccine 479,400 513,570 528,360 1,521,330 Hib Vaccine 9,500,000 7,600,000 7,600,000 24,700,000 Revaccination 3,135,000 2,508,000 2,508,000 8,151,000 Total 1,719,360 1,537,080 14,428,716 11,867,142 11,887,500 41,439,798

Note: Cost estimates based on birth cohort plus 30% wastage. Introduction of MMR and Hib is planned for 2003

Funding sources for vaccine supply have been secured through (i) the Republican bud- get, the Japanese Government, and UNICEF, as noted above; and (ii) the Global Alliance for Vaccines Initiative (GAVI), which has agreed to support the introduction of Hib and hepatitis B vaccines. The phased allocation of resources from the Republican budget for the primary series of vaccines is envisaged to increase from $36,000 in 2001 to $84,000 in 2005. The requirements for hepatitis B from 2001, and Hib from 2003 are to be met via GAVI until 2005. The total amount of funding from GAVI over the five-year period is almost $37 million.

No funding source has been identified for MMR. 44

Vaccine regulation and quality assurance

The NRA should be supervised by the Ministry for Health Care, and its operations and activities should be organized according to regulations approved by the MOH. Priority activities for the NRA should include: • Vaccine approval and licensing • Post-marketing surveillance for quality, efficacy, and safety, and cold-chain monitoring • Supervision of AEFI surveillance and follow-up

Costs and financing

Apart from the physical facilities (building, basic laboratory equipment), which already exist, the requirements and costs of establishing a National Regulatory Agency and strength- ening it to support the immunization program are given in Table 18.

Table 18: Cost Estimates for the Establishment of a National Regulatory Agency and National Surveillance Laboratory, 2001–2005 (US$)

Item 2001 2002 2003 2004 2005 Total Establishment and staffing of NRA and Surveillance Laboratory 130 130 130 130 130 650 Staff attendance at seminars on vaccine licensing/quality 2,400 2,400 2,400 2,400 2,400 12,000 Computer and information technology hardware 940 ---- 940 Laser printer, photocopier, cartridges, diskettes, paper 1,370 1,370 1,370 1,370 1,370 6,850 Laboratory diagnostic supplies/preparations 85,540 57,340 42,763 42,763 - 228,406 Travel expenses 328 328 328 328 328 1,640 Total 90,708 61,568 46,991 46,991 4,228 250,486

Cold chain

An important factor in ensuring the quality of the immunization program is the cold chain. In this regard, the following areas require improvement: • Refrigeration. Of the 4,500 or so vaccination clinic rooms nationwide, around 250 do not have any refrigerators, and 25 percent of all refrigerators in use were purchased before 1980. Temperature monitoring at all levels, ice production, capacity to freeze ice packs for vaccine transportation, and storage capacity for routine vaccination clinics are all lacking. • Repairs and maintenance. Limited repair and maintenance capacity, limited spare parts, and the absence of a maintenance inventory compromises the effectiveness of the cold chain. • Power supply. Additional autonomous power sources are required for institutions storing vaccines (at Republican, oblast, city, and rayon SESs). • Management capacity requires strengthening.

Costs and financing

The estimated cost of upgrading the cold chain over the next five years is shown in Table 19. Around $180,000 is required in the first year, and close to $1 millon over the five years. 45

Table 19: Equipment for Cold-Chain Upgrade, 2001–2005 (cost in US$)

2001 2002 2003 2004 2005 Item No. Cost No. Cost No. Cost No. Cost No. Cost Total Cost Cold-chain equipment Cold room 1 515 515 Freezers 3 564 3 564 2 376 1 188 1 188 1,880 MK40 refrigerators 88 61,600 50 35,000 60 42,000 95 66,500 0 0 205,100 Refrigerators 12 2,400 50 10,000 40 8,000 40 8,000 80 16,000 44,400 Cold packs, 20-liter 8 520 8 520 8 520 8 520 8 520 2,600 Cold packs, 4.5-liter 110 3,850 110 3,850 110 3,850 110 3,850 110 3,850 19,250 Refrigerator stabilizers 25 25,000 60 60,000 60 60,000 95 95,000 60 60,000 300,000 Power generators 14 8,400 12 7,200 12 7,200 11 6,600 11 6,600 36,000 Transport Refrigerated vehicle 1 35,000 35,000 Transport vehicle 1 20,000 1 20,000 1 20,000 3 60,000 2 40,000 160,000 Maintenance 10 25,000 10 25,000 10 25,000 10 25,000 10 25,000 125,000 Total 182,849 162,134 166,946 265,658 152,158 929,745

The upgrading of the cold chain will be phased over five years with priority being given to the strengthening of vaccine transportation between central and regional stores. Multi- bilateral financial support from the Japanese Government (around $440,000) will be used to procure equipment for storing and transporting vaccines. The Kyrgyz Government and the World Bank will also contribute $163,000 and $49,000, respectively.

Safe immunization practice

Safe immunization practice and AEFI surveillance have been identified as priorities of the immunization program. Noncritical assessment of morbidity and pathology after the vaccination period could discredit the immunization program and lose public confi- dence in the safety of vaccinations.

Though present-day vaccines are considered safe, the risk of side effects and complica- tions cannot be discounted. However, there are no reliable national data currently avail- able for assessing the incidence of AEFI in the Kyrgyz Republic.

The main strategies defined in the national plan for assuring safe immunization practice are: • Providing a centralized, uninterrupted supply of high-quality vaccines with diluents, disposable syringes, and safe containers for disposal • Improving safety and safe vaccine handling • Disposing of needles and syringes safely • Developing a system of AEFI surveillance

Costs and financing

The total cost of injection equipment for both the primary and revaccination schedules over the next five years is just over $1 million, as shown in Table 20. 46

Table 20: Cost Estimates for Disposable Injection Equipment, 2001–2005 (US$)

Item 2001 2002 2003 2004 2005 Total DPT Primary series 35,700 35,700 35,700 35,700 35,700 178,500 Revaccination series 11,900 11,900 11,900 11,900 11,900 59,500 BCG Primary series 7,500 7,500 7,500 7,500 7,500 37,500 5-ml syringes 460 460 460 460 460 2,300 Hepatitis B Primary series 29,400 23,100 23,100 23,100 23,100 121,800 Measles Primary series 14,700 14,700 29,400 Revaccination series 7,770 7,770 7,770 7,770 7,770 38,850 Outbreak response syringes 5,796 5,796 5,796 5,796 5,796 28,980 OR, 5-ml 940 940 940 940 940 4,700 Mumps Primary series 8,400 8,750 17,150 Outbreak response syringes 2,940 2,625 2,730 2,900 3,003 14,198 OR, 5-ml 369 385 398 424 440 2,016 ADT Revaccination series 9,940 10,220 10,570 10,710 11,060 52,500 Outbreak response syringes 2,982 3,066 3,171 3,220 3,318 15,757 ADT-M Revaccination series 36,400 37,980 38,500 39,900 41,300 194,080 Outbreak response syringes 10,920 11,340 11,550 11,970 12,390 58,170 MMR Primary series 18,095 19,327 19,550 56,972 Hib Primary series 31,500 25,200 25,200 81,900 Revaccination series 11,200 8,890 8,890 28,980 Total 186,117 182,232 220,880 215,707 218,317 1,023,253

Note: Cost estimates based on birth cohort plus 30%. Introduction of MMR and Hib is planned for 2003

The requirements and costs of improving safety elements in the immunization program, including safety boxes and incinerators, are given in Table 21.

No external funding sources have been identified. The Kyrgyz Government will contribute $15,000.

Table 21: Estimated Cost of Improving Immunization Safety, 2001–2005 (cost in US$)

2001 2002 2003 2004 2005 Item No. Cost No. Cost No. Cost No. Cost No. Cost Total Cost Incinerators 70 70,000 200 200,000 330 330,000 450 450,000 450 450,000 1,500,000 Injection safety boxes 1,5m 750,000 1,5m 750,000 1,5m 750,000 1,5m 750,000 1,5m 750,000 3,750,000 Additional staff for AEFI surveillance 9 918 9 918 9 918 9 918 9 918 4,590 Specialist staff to conduct AEFI review 27 1,566 27 1,566 27 1,566 27 1,566 27 1,566 7,830 Emergency equipment for AEFI 700 21,000 700 21,000 ------42,000 Total 843,484 973,484 1,082,484 1,202,484 1,202,484 5,304,420 47

Staff training

Staff development is an important component of the revised National Immunization Strategy. The major training needs are: • Curriculum introduction and monitoring at all levels, including pre-diploma training at the Kyrgyz State Medical Academy and compulsory immunization training at medical departments of tertiary institutions • Post-diploma training via yearly courses at the CCME and Republican Immuniza- tion Center, in thematic workshops targeted to employees of research medicine institutes; professors of medical academies; managers and coordinators of immu- nization programs at Republican, oblast, city, rayon, and FGP levels; immunolo- gists, epidemiologists, pediatricians, obstetricians, and other specialists; and labo- ratory staff • Specific specialized training in the quality control of vaccines and other related drugs, and laboratory surveillance of vaccine-preventable infections, for pathologists, immu- nologists, and immunobiological staff • Training for nursing and other technical staff on the specifics of cold-chain manage- ment, and for FGP specialists and vaccinators on issues relating to vaccine and immu- nization safety

Costs and financing

The requirements and costs of improving staff development and training in the immuni- zation program are given in Table 22.

There are no identified external funding sources. The Kyrgyz Government will contribute $24,000.

Table 22: Cost Estimates for Training and Development Activities, 2001–2005 (US$)

Item 2001 2002 2003 2004 2005 Total Updating/Provision of medical and nursing tertiary curriculums 155 - - - - 155 Development and publication of scientific/medical texts on immunology, microbiology, and epidemiology 2,775 1,000 1,000 1,775 1,000 7,550 Development and publication of texts on vaccine quality, licensing, and surveillance 320 - - 160 - 480 Accreditation course for immunologists 5,000 - - 5,000 - 10,000 Training courses for heads of Immunoprophylaxis Centers 525 - 525 - 525 1,575 Three-week skills updating workshops for physicians 700 700 700 700 700 3,500 Three-week skills updating workshops for nurses 700 700 700 700 700 3,500 Physician training in surveillance /computer monitoring - - 700 700 700 2,100 Six-hour training, CCME program on immunization for nonspecialists 435 435 435 435 435 2,175 Eighteen-hour continuing training program for family physicians 8,830 8,830 8,830 - - 26,490 Twelve-hour continuing training program for FAP nurses 9,000 9,000 9,000 - - 27,000 Field seminars for immunization staff 10,500 10,500 10,500 14,000 5,240 50,740 Specialist training in vaccine licensing 2,400 2,400 2,400 2,400 2,400 12,000 Retraining cycles for physicians, bacteriologists, and virologists 700 700 700 700 700 3,500 Total 42,040 34,265 35,490 26,570 12,400 150,765 48

Social mobilization

Social mobilization is aimed at informing all sections of the population about the impor- tance of immunization and ensuring adequate access to immunization services either routinely or as part of a campaign. To date, this has been done through religious, social, and other organizations and, importantly, healthcare workers.

The following major soci’al mobilization strategies have been identified for the Kyrgyz Republic over the next five years: • Review the strategies used in the five-year period 1994–2000 • Survey key information sources, knowledge, and attitudes to: – develop and publish methodology materials on immunization – develop the policy and concept of a work program for mass media, the public, and parents in case of adverse events • Develop active groups of social mobilization workers among teachers, preschool edu- cators, and members of nongovernment organizations • Conduct workshops on social mobilization • Develop audiovisual media resources, videos, etc., and publish research and popular literature in various languages (Kyrgyz, Russian, etc.)

Costs and financing

The requirements and costs of social mobilization for the immunization program are given in Table 23. The Kyrgyz Government will contribute just over $7,000; however, there are no other funding sources.

Table 23: Cost Estimates for Social Mobilization Activities, 2001–2005 (US$)

Item 2001 2002 2003 2004 2005 Total Survey to measure knowledge and attitudes toward immunization 836 836 836 836 - 3,344 Publication and distribution of methodology materials 3,350 - - - - 3,350 Development/Publication of lecture materials 3,350 - - - - 3,350 Broadcasts and public announcements 800 800 800 800 800 4,000 Development of a short film on immunization issues 4,000 - - - - 4,000 Research and development and publication of information materials for general distribution 2,000 2,000 2,000 2,000 2,000 10,000 Supporting audiovisual equipment 2,000 2,000 2,000 2,000 2,000 10,000 Total 16,336 5,636 5,636 5,636 4,800 38,044

Research

A requirement for the new immunization program will be to develop an appropriate research agenda that supports the major investments in vaccine-preventable disease con- trol, and specifically the expansion of the immunization program to include new diseases and antigens.

The MOH has identified three major areas for research activity: • Population-based surveys to determine Hib incidence • Sero-epidemiological monitoring of rubella and CRS • Assessment of the disease burden of vaccine-preventable disease 49

Research on these issues will provide both epidemiological and cost-effectiveness data to guide technical and policy directions for the routine immunization schedule, and gauge progress on disease elimination strategies.

Costs and financing

The requirements and costs of research activities for the immunization program are given in Table 24. The Kyrgyz Government will contribute about $4,000, but there are no other funding sources.

Table 24: Cost Estimates for Research Activities, 2001–2005 (cost in US$)

2001 2002 2003 2004 2005 Item No. Cost No. Cost No. Cost No. Cost No. Cost Total Cost Diagnostic immuno-assay equipment for measles 1,100 44,000 1,100 44,000 1,100 44,000 1,100 44,000 1,100 44,000 220,000 Diagnostic immuno-assay equipment for rubella 300 12,000 300 12,000 300 12,000 300 12,000 300 12,000 60,000 Diagnostic tests for hepatitis B 300 3,000 300 3,000 300 3,000 300 3,000 300 3,000 15,000 Diagnostic tests for Hib infection 200 88 200 88 200 88 200 88 200 88 440 Laboratory equipment – 1- and 8-channel automatic pipette 4 2,776 4 2,776 ------5552 Laboratory equipment – tips for automatic pipettes 320 31,200 320 31,200 320 31,200 320 31,200 320 31,200 156,000 Publication of technical laboratory material 500 2,000 - - 500 2,000 - - - - 4,000 Publication of articles/booklets 1 4 1 4 2 8 1 4 2 8 28 Hiring of venue for presentations - - 2 50 3 75 2 50 - - 175 Total 95,068 93,118 92,371 90,342 90,296 461,195

Surveillance

There are many elements of surveillance activities relevant to the immunization program. The four primary indicators requiring effective surveillance systems are vaccination cover- age, vaccine-preventable disease incidence, AEFI incidence, and sero-prevalance of popu- lation immunity.

So far, the MOH has been able to routinely report vaccination coverage and VPD incidence based on written recording and reporting systems. While some incidents associated with vaccine associated morbidity have been reported, there has not been a comprehensive system in place for AEFI or antibody sero-prevalance monitoring.

A group of leading specialists of the MOH, in cooperation with the American Project BASICS, have developed the new information system (MIS) of reporting and recording documentation and monitor of the immunization work and put it into practice at the medical and prophylaxis establishments. A manual has been produced for four levels of health institutions unifying the earlier recording and reporting forms.

The RCI has introduced the first component of the WHO electronic information system on communicable diseases, which helps to track the effectiveness of the epidemiological control over AFP (Acute Flaccid Paralysis) cases. 50

The requirements and costs of supporting general surveillance activities for the immuni- zation program relate to the development of recording and reporting systems based around information technologies. Improving both clinical and laboratory surveillance capacity is required to further support other key program strategies for research, disease elimination, and improving vaccine regulatory (NRA) activities.

Costs and financing

The requirements and costs for surveillance for the immunization program are outlined in Table 25. The Kyrgyz Government will contribute just over $2,500, UNICEF $10,000, and the World Bank $200,000.

Table 25: Cost Estimates for Enhanced Surveillance Logistic Support, 2001–2005 (cost in US$)

Cost Item No. 2001 2002 2003 2004 2005 Total Cost Computers (desktop) 8 2,820 2,820 1,880 - - 7,520 Laser printers 8 270 270 180 - - 720 Photocopiers 8 5,640 5,640 3,960 - - 15,240 Motor vehicles 8 14,100 14,100 9,400 - - 37,600 Computer supplies (disks,cartridges) 8 2,856 2,856 2,856 2,856 2,856 14,280 Software development 8 14,100 14,100 9,400 - - 37,600 Development of surveillance system 10 900 900 780 - - 2,580 Travel for technical support 16 2,102 2,102 2,102 2,102 2,102 10,510 Bacteriology equipment (Labsystem) 9 77,268 61,814 - - - 139,082 Virology equipment 120 1,080 1,080 1,080 1,080 1,080 5,400 Diphtheria/pertussis diagnostic media 100 1,000 1,000 1,000 1,000 1,000 5,000 Total 122,136 106,682 32,638 7,038 7,038 275,532

Elimination of measles and congenital rubella syndrome

In November 1999, MOH approved a long-term strategy (developed jointly by the Govern- ment and the Centers for Disease Control, Atlanta) for eliminating measles and preventing congenital rubella infection by 2007. The proposed strategy consists of an initial mass immunization for 7- to 25-year-olds with measles/rubella vaccine. The first of these campaigns is planned for late 2001, with all people in the target population of 1.95 million being offered vaccination irrespective of their vaccination history. Two doses of measles, mumps, rubella (MMR) vaccine will subsequently be introduced into the rou- tine immunization schedule starting in 2003. The national working group on measles and congenital rubella infection elimination will meet in March 2001. Local and regional campaign implementation plans will be completed by July 2001.

From 2001, the system of epidemiological surveillance for measles and rubella and congenital rubella infection will be introduced, based on policies for the active follow-up of all suspected clinical cases. Laboratory confirmation will be obtained using specific 51

IgM antibody detection by the virology laboratory of the Republican SES and the subnational laboratory. A pre- and post-campaign sero-prevalance survey will be under- taken to define the level of measles and rubella infection susceptibility in the population and evaluate the measles and rubella campaign.

Costs and financing

The estimated costs of conducting a national measles and rubella vaccination campaign are shown in Table 26. At the time this report was compiled, no funding had been secured from either internal Government sources or donors.

Table 26: Cost Estimates for National Measles and Rubella Mass Campaign (US$)

Item Item Cost Shipping and Handling Cost Total Cost Funding Gap MR vaccine, 2,535,000 doses 1,115,400 90,905 1,206,305 1,206,305 AD syringes 160,650 37,914 196,564 196,564 Safe disposal boxes 1,403 331 1,734 1,734 Logistics 150,000 4,500 154,500 154,500 Training of health workers 20,000 600 20,600 20,600 Social mobilization 200,000 6,000 206,000 206,000 Monitoring and evaluation 30,000 900 30,900 30,900 Project support 30,000 900 30,900 30,900 Total 1,707,453 142,050 1,849,503 1,849,503

Financing Needs, Sources, and Gaps

The following analysis is only at a national level. There are not enough data to examine the financing gaps that undoubtedly exist at the oblast level and contribute to uneven access across the country to safe, quality vaccinations.

Projected costs of strengthened program

The operational costs involved in strengthening the national immunization program over the next five years are projected and summarized in Table 27. Program implementation will cost $5.1 million in 2001, and $51.7 million over a five-year period. On average, vaccines account for 80 percent of the total.

Financing gap

Table 28 shows the gap in financing for an improved EPI over the next five years, based on expected commitments from donors and the assumption that the Kyrgyz Government will meet all routine operational costs, including EPI vaccines. This analysis suggests that $9.7 million more will be needed to undertake all improvements. 52

Table 27: Projected Costs, EPI, 2001–2005 (US$)

Item 2001 2002 2003 2004 2005 Total Vaccines 1,719,360 1,537,080 14,428,716 11,867,142 11,887,500 41,439,798 Syringes 186,117 182,232 220,880 215,707 218,317 1,023,253 MMR campaign 1,849,503 1,849,503 Immunization safety 843,484 973,484 1,082,484 1,202,484 1,202,484 5,304,420 Cold chain 182,849 162,134 166,946 265,658 152,158 929,745 Surveillance 122,136 106,682 32,638 7,038 7,038 275,532 NRA and NCL 90,708 61,568 46,991 46,991 4,228 250,486 Staff development 42,040 34,265 35,490 26,570 12,400 150,765 Social mobilization 16,336 5,636 5,636 5,636 4,800 38,044 Research activities 95,068 93,118 92,371 90,342 90,296 461,195 Total 5,147,601 3,156,199 16,112,152 13,727,568 13,579,221 51,722,741

Table 28: EPI Financing Gap, 2001–2005 Funding Sources (US$) Total Republican UNICEF World Total Funding % of Item Needs (US$) Budget JICA GAVI Bank Sources Gap (US$) Total Gap Vaccines 41,439,798 Syringes 1,023,253 Subtotal 42,463,051 2,693,599 1,418,200 36,956,250 41,068,049 (1,395,002) 14.3 MMR campaign 1,849,503 (1,849,503) 19.0 Immunization safety 5,304,420 14,590 14,590 (5,289,830) 54.3 Cold chain 929,745 163,395 442,760 49,000 655,155 (274,590) 2.8 Surveillance 275,532 2,580 10,400 200,162 213,142 (62,390) 0.6 NRA and NCL 250,486 650 650 (249,836) 2.6 Social mobilization 38,044 7,344 7,344 (30,700) 0.3 Staff development 150,765 23,920 23,920 (126,845) 1.3 Research activities 461,195 4,195 4195 (457,000) 4.7 Total 51,722,741 2,910,273 1,871,360 36,956,250 249,162 41,987,045 (9,735,696)

The primary funding gaps identified, as shown in Table 29, are: • MMR vaccine (and associated injection equipment) for 2003–2005 • Immunization safety, specifically waste and sharps incineration, sharps disposal and containment, hiring of specialist staff to review AEFI management, and the purchase of medical and clinical equipment for AEFI treatment and management • Cold chain, specifically refrigeration and vaccine transport requirements • Surveillance, specifically logistical support items for surveillance activities, including information technology support, software development, and transport and travel for establishment and support • National Regulatory Agency and National Control Laboratory, specifically the necessary laboratory and diagnostic equipment for sero-prevalance testing and the diagnosis and confirmation of vaccine-preventable diseases, as well as specialist staff training, labo- ratory equipment, and diagnostic supplies • Social mobilization, specifically a population-based survey on immunization, research and development and the publication of media materials, and the funding of media broadcast costs 53

• Strengthened staff development, specifically the development of an undergraduate curriculum in immunization, publication and distribution, the development of a cer- tification course, specialist in-service training, and field/workplace-based training for immunization staff • Research activities

Table 29: Funding Gaps for Strengthened EPI, 2001–2005 (US$)

Item 2001 2002 2003 2004 2005 Total Vaccines (MMR) 1,395,002 MMR campaign 1,849,503 1,849,503 Immunization safety 837,566 967,566 1,081,566 1,201,566 1,201,566 5,289,830 Cold chain 28,038 43,638 41,638 91,638 69,638 274,590 Surveillance 19,058 19,058 14,358 4,958 4,958 62,390 NRA and NCL 90,708 61,438 46,861 46,861 4,098 249,836 Social mobilization 14,800 4,100 4,100 4,100 3,600 30,700 Staff development 36,600 30,130 30,830 20,285 9,000 126,845 Research 93,064 93,064 90,288 90,288 90,288 456,992 Total 2,969,337 1,218,994 1,309,641 1,459,696 1,383,148 9,735,688 CHAPTER XI Policy Options

Vaccine Wastage

Vaccine wastage is a critical area to focus on when attempting to minimize costs, particularly when expensive vaccines such as hepatitis B and Hib B are being intro- duced. Strategies to reduce or minimize wastage, which the Government should con- sider, include: • Aiming for a wastage factor of 25 percent for 10-dose vials and 5 percent for single- dose vials • Implementing the WHO open-vial policy he Government needs • Carefully planning immunization sessions, as well as scheduling regular visits by the immunization team to the less-populated areas Tto remain committed to improving the national National Regulatory Capacity capacity for vaccine An independent National Regulatory Agency and National Surveillance Laboratory should be established to provide the Kyrgyz Government with the capacity to ensure vaccine safety, regulation, as this will quality, and efficacy. The Government needs to remain committed to improving the national capacity for vaccine regulation, as this will eventually facilitate the procurement eventually facilitate the of good-quality vaccines at the best possible price. Developing a National Regulatory Agency requires technical expertise and laboratory logistics. procurement of good- quality vaccines at the best Cold Chain possible price While some donor support for improving cold-chain logistics has been obtained over the past five years, a significant number of deficiencies remain. These relate primarily to the quality of refrigeration, storage, and transportation equipment and adherence to cold- chain policies at the subnational level. Unreliable power in many districts is also an issue in maintaining vaccine potency.

Unless the cold chain is robust and reliable, the potential for large financial losses is high, particularly with the imminent introduction of new (and expensive) vaccines. Therefore, to ensure vaccine safety, efficacy, and cost-efficiency, the Kyrgyz Government must address this issue as a priority.

Immunization Safety

No major incidents associated with unsafe immunization practices have been reported, and relevant WHO policies are adopted nationwide. Yet major improvements are needed in sharps and waste disposal. There is a lack of suitable incineration facilities. The system for AEFI reporting and follow-up also requires improvement. 56

Social Mobilization

In view of the Government’s plans to expand and modify the immunization program, the use of information strategies becomes increasingly important. The community must be informed and comfortable with the immunization schedule, as this can, to a large extent, drive demand and facilitate sustainability. The revised national strategy defines a number uccesses in achieving high of key activities for optimizing immunization services demand and access, and these must be given due attention. Scoverage of routine vaccination against measles Research and Training have enabled the Kyrgyz The major research and training needs for the immunization program relate to the development of undergraduate and postgraduate curriculums and improved assessment Republic to progress toward of the burden of vaccine-preventable disease. The proposed introduction of Hib and rubella vaccine into the routine vaccination schedule will require a better understanding the goal of measles elimination of preexisting epidemiology and monitoring of vaccine efficacy.

Elimination of Measles and Congenital Rubella

Successes in achieving high coverage of routine vaccination against measles have enabled the Kyrgyz Republic to progress toward the goal of measles elimination. An important component of this strategy will be a national measles and rubella mass vaccination campaign planned for 2001. The technical and logistical requirements for this campaign have been developed; however, financing has not been secured, and attention should be paid to mobilizing this. CHAPTER XII Recommendations

To build on the advances made from previous policies and initiatives, and considering the issues identified within the framework of the revised National Immunization Strategy 2001–2005, it is recommended that the Government of Kyrgyz Republic:

1. Strengthen the administration of the immunization program by fully sup- porting the Coordination Committee on Immunoprophylaxis created at the MOH. The First Deputy Minister of Health should continue as Chairman of the Committee and be responsible for its work. The primary tasks of the committee should be to: (i) Assist in the development and realization of strategic plans for the support and improvement of the immunoprophylaxis services, in the framework of healthcare reforms. (ii) Ensure financial support for all target programs of vaccine prevention for chil- he Government of Kyrgyz dren and other groups in the population. (iii) Monitor the status of immunoprophylaxis in the Kyrgyz Republic and provide Republic should recommendations based on the experience of European countries and adapted T to the conditions in the Kyrgyz Republic. strengthen the administration (iv) Review and report on the economic impact of measures to improve the immuni- zation program of the Republic. of the immunization program (v) Coordinate immunization program activities with those of other international organizations. by fully supporting the (vi) Look for other funding opportunities for purchase of vaccines within the existing funding system to avoid financial risk to the immunization program. Coordination Committee on (vii) Ensure financial support at all levels for the technical equipment of the Center for Immunoprophylaxis.

Immunoprophylaxis created 2. Ensure adequate resource mobilization for the program by: (i) Including an annual national budget line item for vaccines, injection equipment, at the MOH cold-chain equipment, staff training, and social mobilization. (ii) Gradually increasing the Government’s share in the VII for the procurement of the primary series of vaccines for children up to 2 years old, and nonvaccine program elements.

3. Develop a medium- to long-term procurement strategy by: (i) Taking the opportunity during the next VII to develop a comprehensive procure- ment strategy that considers options beyond 2005. (ii) Considering registration and licensing requirements and their impact on com- petitive tendering, with the long-term objective of having the capacity and options to procure all vaccines and cold-chain and injection equipment at a competitive price without the assistance of the UNICEF supply mechanism.

4. Minimize vaccine wastage by: (i) Continuing to review the proportion of usage of single-dose vials (20 percent of total requirements) to multi-dose vials (ii) Aiming for a wastage factor of 25 percent for 10-dose vials and 5 percent for single-dose vials (iii) Continuing to implement the WHO open-vial policy 58

5. Strengthen the functions of the National Regulatory Agency by working with WHO to develop all four recommended regulatory functions for countries importing vaccines.

6. Strengthen and develop immunization safety and quality by: (i) Monitoring and reporting on progress made since the issuance of the 1998 order “Safe Immunization Practices and Creation of the System of Epidemiological Surveillance for Adverse Effects Following Immunization,” based on the WHO- he Government should UNICEF policy. (ii) Vaccinating children under 2 years old with auto-disable syringes, starting in also strengthen the 2000. Used syringes should be disposed of safely, using safe disposal boxes. T (iii)Mobilizing support for UNICEF to pilot a project on the De Monfort University functions of the National incinerator in Bishkek, and for the World Bank to build an incinerator in each rayon hospital in 2001 under the “Health 2” reform project. Regulatory Agency by 7. Maximize the impact of introducing routine infant hepatitis B vaccine by: working with WHO to (i) Implementing strategies that support the safety of medical procedures and of blood and blood products, and a reduction in sexual and perinatal transmission develop all four of hepatitis B. (ii) Specifying targets and accountability for: recommended regulatory • mandatory vaccination of newborns within 24 hours after delivery • immunization of all children up to 1 year old functions for countries • immunization of teenagers 12 years of age • immunization of high-risk groups (health workers, contact persons of HbsAg importing vaccines carriers, patients with chronic diseases).

8. Increase the commitment to the immunization strategy at all levels in the system by releasing, together with the National Plan on Immunization 2001–2005, a schedule for pre-service and in-service training on the program’s main strategies for all medical professionals dealing with immunization. Emphasis should be given to the new information-analytical system of monthly coverage monitoring and vac- cine utilization. APPENDIX Persons Interviewed

Kazakhstan

Mr M. Ussataev (WHO Liaison Office, Almaty)

Ms G. Musenova, Ms L. Syzdykova, Mr T. Bespalinov (Ministry of Economy, Astana)

Ms E. Shtol, Ms G. Kembvabanova (Sanitary Epidemiological Station, Astana)

Ms S. Elfunova (Sanitary Epidemiological Station, Almaty)

Mr S. Satekov (Sanitary Epidemiological Station, Karaghanda)

Mr R. Kuandykov (Sanitary Epidemiological Station, Kozylorda)

Mr A. Askarov (Republican Agency for Healthcare, Astana)

Mr R. Sissemielev (UNICEF Office, Almaty)

Kyrgyz Republic

Mr O. Moldokulov, Dr S. Deshevoi (WHO Liaison Office, Bishkek)

Mr A. Aaliev (Ministry of Finance, Bishkek)

Ms I. Sultanovna (Ministry of Health, Bishkek)

Mr S. Abdikarimov (State Sanitary Epidemiological Dept., Bishkek)

Dr S. Firsova (Republican Center for Immunoprophylaxis, Bishkek)

Mr S.Sheraliev (State Committee on Foreign Investments and Economic Development, Bishkek)

Mr K. Maskall, Ms C. Aidyralieva (UNICEF Office, Bishkek) References

Asian Development Bank. 2000. Country Assistance Plan: Kazakhstan 2001–2003.

European Observatory on Health Care Systems. 1999a. Health Care Systems in Transition: Kazakhstan.

______. 1999b. Health Care Systems in Transition—Kyrgyz Republic.

Ministry of Health, Kyrgyz Republic. 1996. MANAS National Programme on Health Care Reforms (1996–2000).

Ministry of Health, Kyrgyz Republic. 1998. Kyrgyz Republic Demographic and Health Survey 1997.

United Nations Development Programme. 2000. Human Development Report: Kazakhstan 1999.

World Bank. 1996. Kyrgyz Republic Health Sector Reform Project Report.

______. 2000. Kazakhstan Country Assistance Strategy.

World Health Organization, United Nations Children’s Fund, and United States Agency for International Development/Abt Associates. 1999. Assessment of Vaccine Procurement and Quality in the Republic of Kazakhstan. Report.

World Health Organization, United Nations Children’s Fund, BASICS, United States Agency for International Development, and Zdrav Reform. 1999. Immunization and Health Sector Reform in the Kyrgyz Republic. Report.