Second Serbia Health Project: Additional Financing

SFG3987
Second Serbia Health

Project
Additional Financing
ENVIRONMENTAL MANAGEMENT
FRAMEWORK DOCUMENT
FINAL
Belgrade, January 2018
ENVIRONMENTAL MANAGEMENT FRAMEWORK DOCUMENT Page 0

Contents
LIST OF ABBREVATIONS..................................................................................................................................3
EXECUTIVE SUMARY.......................................................................................................................................4
1. DESCRIPTION OF PROJECT COMPONENTS INCLUDING DESCRIPTION OF TYPE OF ACTIVITIES ELIGIBLE
FOR FINANSING..............................................................................................................................................6
1.1 Background....................................................................................................................................6
1.2 Project description........................................................................................................................6
1.2.1 Medical equipment for cancer treatment.................................................................................9
1.2.2 Scope of additional financing..................................................................................................10
1.3 Objectives of the Environmental Management Framework Document......................................12
1.4 Approach and Methodology........................................................................................................13
2. OPERATING REQUIREMENTS – DIAGNOSIS OF LEGAL AND INSTITUTIONAL FRAMEWORK AND
APPLICABLE SAFEGUARDS............................................................................................................................13
2.1 Foreword.....................................................................................................................................13
2.2 Relevant information...................................................................................................................13
2.3 EIA procedure in the Republic of Serbia......................................................................................14
2.4 Other Relevant Government Policies, Act, Rules, Strategies and Guidelines...............................14
2.4.1 The Constitution of Serbia.......................................................................................................15
2.4.2 Law on Health Care.................................................................................................................16
2.4.3 Law on Medical Devices..........................................................................................................16
2.4.4 Law on Ionizing Radiation and on Nuclear Safety....................................................................16
2.4.5 Law on Environmental Protection...........................................................................................17
2.4.4 Law on Environmental Impact Assessment.............................................................................17
2.4.5 The Law on Waste Management.............................................................................................18
2.4.6 The Law on Occupational Safety and Health...........................................................................18
2.4.7 The Law on Planning and Construction...................................................................................18
2.5 World Bank’s Environmental Safeguard Policy............................................................................18
2.5.1 OP/BP 4.01 Environmental Assessment..................................................................................18
2.5.2 OP/BP 4.04 Natural Habitats...................................................................................................19
2.5.3 OP/BP 4.11 Physical Cultural Resources..................................................................................19
2.5.4 OP/BP 4.36 Forestry................................................................................................................20

2.5.5 OP/BP 4.12 Involuntary Resettlement.....................................................................................20
2.5.6 IFC Environmental, Health and Safety Guidelines...................................................................20
3. POTENTIAL ENVIRONMENTAL IMPACTS...............................................................................................20
4. ENVIRONMENTAL MANAGEMENT APPROACH.....................................................................................25
4.1 Application of the EMP-Checklist and EMF on the Project..........................................................25
4.2 Monitoring and Reporting of Component 3 related activities.....................................................26
4.3 Reporting of the Project Related Activities..................................................................................27
5. PUBLIC CONSULTATION........................................................................................................................27
6. IMPLEMENTING ARRANGEMENTS........................................................................................................28
ANNEX 1: Draft Format for EMP/EMF for Construction and Rehabilitation Activities for ECSHD Projects29
ANNEX 2: Table 1: Review comparison between the World Bank EHS Guidelines and Serbian legislation
for the ionization radiation.......................................................................................................................33
ANNEX 3: Rules on limits of exposure to ionizing radiation and measurements to assess the level of
exposure to ionizing radiation, Official Gazette RS, No. 86/11 on 18.11.2011. and Radiation protection of
worker – ionized radiation, International Labor Organization 1987, ISBN 92-2-105996-0.......................36
ANNEX 4: Proposed components of the Additional Financing..................................................................37
ANNEX 5: Report on Public Consultation..................................................................................................45

LIST OF ABBREVATIONS
ALIMS Medicines and Medical Devices Agency of Serbia
AF Additional Financing
AZUS Agency for Accreditation of Health Care Institutions of Serbia
DRG-s Diagnostic Related Group System
EA Environmental Assessment
e-HDF e-Health Development Framework
EIA Environmental Impact Assessment
EMFD Environmental Management Framework Document
EMP Environmental Management Plan
EU European Union
HIF Health Insurance Fund
HTA Health Technology Assistant
LINAC Linear Accelerator
OP Operational Policy
PCF Primary Care Facilities
RDNEIA Request for Decision about Need for Environmental Impact Assessment
SSHP Second Serbia Health Project
T2DM Type 2 Diabetes Mellitus
VOI Autonomous Province of Vojvodina
WB The World Bank
WMP Waste Management Plan
μSv microsievert
MeV megaelectron volt
Gy Grey

EXECUTIVE SUMARY
The Government of Serbia has requested a support from the World Bank in implementation of the
Second Serbia Health Project (SSHP). The main objectives of the Project are to strengthen the health
financing systems by improving incentives for efficiency and quality in provider payments for primary and
hospital care, and build management capacity to respond to these incentives. The other aims of the
Project are to: improve efficiency of purchasing of health products by institutionalizing centralized
procurement of pharmaceuticals, medical supplies, diagnostic reagents and medical devices;
strengthening institutions and capacity to improve the quality of service delivery; strengthen facility
accreditation, and enhancing quality monitoring and use of data for quality improvement; and to
modernize cancer treatment at selected tertiary hospitals. The Project of the Ministry of Health Republic
of Serbia will be implemented over five years, and will include the following four components: Component
1 – Improving Health Financing; Component 2 – Promote Efficient Purchasing of Health Products and
maintenance of Medical Equipment; Component 3 – Support Quality improvement in Service Delivery
including for Management of Cancer Treatment; and Component 4: Support Project Management,
Monitoring and Evaluation Component 1 – Health Financing; Component 2 – Efficient Purchasing of Health
Products; Component 3 – Quality of Service Delivery; Component 4 – Modernizing Tertiary Cancer
Treatment; and Component 5: Monitoring, Evaluation, and Project Management.
The Project is rated environmental category B. Most of the Project Components are
environmentally neutral; however, Component 3 will include installation of the medical equipment (linear
accelerators) into already existing, purpose-built facilities (bunkers) that will be modified, to suit
specifications of the new equipment. The related civil works activities will be undertaken within existing
hospitals and medical centers throughout Serbia, and are not expected to have any long-term, significant
negative environmental impact. The EMF document sets the guidance framework for preparation of site-
specific EMPs, to be prepared when the sites and proposed equipment have been identified.
Linear accelerators for treatment of cancer do not contain any radioactive substances, but instead
use electricity to generate either high-energy x-rays or accelerated electrons that can be precisely
targeted on cancerous tissue. When not in operation, no harmful radiation is generated, although the
treatment room itself requires shielding of the walls, doors, and ceiling to prevent escape of scattered
radiation during the radiotherapy treatment. The solution applied is similar to the arrangement used to
protect staff using diagnostic x-ray equipment, although the higher energy of therapy beams requires a
radiation vault (bunker) with thick concrete walls (up to 2.5 m) to provide adequate radiation shielding.

The issues related to civil works and construction of radiation vaults (bunkers) include noise, dust,
vibrations, and management of construction waste during civil engineering activities - which could be
successfully managed and mitigated by application of good engineering practices. Specific issues that will
also be taken care of relate to management of the site (as hospitals must continue operating during the
execution of works), and health and safety of hospital users and staff. In some cases, the presence of
asbestos, lead or other medical or possibly hazardous waste (if found during rehabilitation works), may
require specific handling procedures, which will be defined in site-specific EMPs that are to be prepared
for each facility when the locations become known.
During the Project preparation it will be confirmed whether any of the buildings chosen for
rehabilitation are designated cultural property. As provided for in the EMF, in these cases the site-specific
EMPs will include clauses related to heritage protection and conservation. The civil engineering works will,
in addition, have to be reviewed and approved by competent national cultural heritage institutions.
The Project may also fund construction of new facilities (bunkers) to house linear accelerators.
These facilities will be constructed within the existing hospital buildings (without change of footprint), or
in adjacent buildings – within the existing hospital compounds.
The potential for negative impact will exist during operation of the accelerator equipment, in case
that Serbian standard for ionizing radiation and nuclear safety is not adequately applied. The Project will,
as a part of the design and permitting process, ensure for each piece of equipment that relevant standards
are applied and design is certified by the Institute of Occupational Health of Serbia. Additionally, the Word
Bank EHS Guidelines and ILO Code of Practice “Radiation Protection of Workers (Ionizing Radiation)” will
apply to all sites under Project Component 3. As a rule, whenever the Serbian and World Bank standards
and guidance documents differ on environment, health and safety issues, the more stringent ones will be
applied. According to comparison made between the national and World Bank EHS Guidelines, there are
no substantial differences between the two standards, since the Serbian legislation adopted the
recommendations of the International Commission on Radiological Protection (ICRP), the standards of
International Agency for Atomic Energy (IAAE) and the best international practice in this area.
For the reference, both Serbian and World Bank standards for safety from ionizing radiation, and
their comparison, are attached in Annexes 2 and 3.
Within the parent project, sub-component 3.2, four (4) locations: Institute for Oncology and
Radiology of Serbia, Nis Clinical Centre, Kragujevac Clinical Center and Kladovo Health Center have been
designated for purchase and installation of linear accelerators. For that purpose, specially sheltered
bunkers were planned to be constructed and in case of existing ones, to be reconstructed or adapted.
During the preparation of technical project documentation for sheltered bunkers construction and / or

reconstruction, site-specific Environmental Management Plans (EMPs) have been prepared for each
location. The EMPs were included in the bidding document (Tender Dossier) and subsequent, in
construction contract. The construction works of bunkers for LINAKs accommodation are in progress and
are expected to be completed by June 2018.
1. DESCRIPTION OF PROJECT COMPONENTS INCLUDING DESCRIPTION OF TYPE

OF ACTIVITIES ELIGIBLE FOR FINANSING
1.1 Background
The current situation in the Health care system in Republic of Serbia is complicated considering
the efficiency of primary and hospital care, and the situation with the purchase and installation of high-
tech medical equipment, as well as hospital staff training. The prevention of most common diseases and
the enhancement of the healthcare quality monitoring and use of data for healthcare quality
improvement will be one of the goals to attain. By improving the efficiency and quality of the Health
financing system most of the weaknesses of the health care system will be remedied.
1.2 Project description

The activities that are financed within the SSHP and with the support of the World Bank, are
structured into four components.
Component 1: Improving Health Financing (US$7.6 million)
This component supports reforms to improve the quality, efficiency, and transparency of HIF financing for
primary care and hospitals. The component finances technical assistance, training, goods and equipment
to support the design and implementation of incentives and oversee results; finance initial piloting of a
quality improvement grants scheme to DZs; and supports upgrades of information technology capacity to
improve financial reporting and performance monitoring at central, hospital, and primary levels.
Sub-component 1.1: Hospital Financing Reforms (US$3.7 million)
This sub-component supports reforms to strengthen transparency of and incentives for efficiency of HIF
financing for public hospitals. The major focus is supporting the phased implementation of a Diagnostic
Related Group (DRG) payment system for acute care at hospitals.
Sub-component 1.2: Primary Health Care Financing (US$3.9 million)

Primary care financing activities aim to improve the efficiency and quality of key preventive and other
primary care services tailored to the burden of disease in Serbia and to the patient profiles registered with
DZ providers. This component supports technical assistance to strengthen primary health care financing
systems. The grants scheme seeks to develop criteria for risk-adjusted capitation as a basis for HIF
payments and to incentivize facility-level quality improvements related to priority conditions.
Component 2: Efficient Purchasing of Pharmaceuticals and Medical Products (US$7.0 million)

Activities under this component are organized around the following main areas: support for centralized
procurement of drugs and supplies through framework contracts; strengthening of Health Technology
Assessment (HTA); and improving systems for medical equipment maintenance. Activities in this area
support TA, training and equipment, including a piloting of a multi-vender medical equipment
maintenance contact.
Sub-component 2.1: Centralized Procurement (US$2.3 million)
This sub-component supports introduction and implementation of framework agreements to centralize
the procurement of pharmaceuticals, medical supplies, diagnostic reagents and medical devices, in order
to increase efficiency of expenditures. Centralized procurement is expected to produce saving up to US$
49 million that represents 14 percent reduction of current expenditure. Centralized procurement would
be implemented by HIF through a competitive tendering process for multi-source drugs, and negotiation
based on reference pricing for single source drugs, with framework agreements.
In addition, this sub-component supports the development and pilot testing of: (i) an e-Prescription
system for primary health centers, hospitals, HIF, HMIS, pharmacies to provide accurate and timely
information on use of drugs and medical supplies, (ii) e-procurement system to support centralized
procurement and purchasing by facilities based on framework prices, (iii) the development of and training
in a unified IT system that will enable the HIF to monitor the in-market availability and dispensing of
pharmaceuticals.
Sub-component 2.2: Health Technology Assessment (US$2.7 million)
This sub-component supports the establishment of an independent unit for HTA, which is expected to be
housed as a Department within the Agency for Accreditation of Health Care Institutions of Serbia (AZUS).
The unit will make recommendations on drugs and equipment to be included in the HIF reimbursement
list, and decisions will be taken by a central committee composed of representatives from MoH, HIF and
IPH.
Sub-component 2.3: Medical Equipment Maintenance (US$2.0 million)

This sub-component supports the improvement of the MoH maintenance system by carrying out a
preliminary assessment of the current (i) distribution of medical equipment; (ii) procedures for
maintenance and repairs management; (iii) costs and allocation of funds for maintenance; and (iv)
procurement of spare parts and services.
Component 3: Strengthening Quality of Service Delivery (US$22.4 million)

This component aims to improve standards of quality and efficiency of care in the Serbian health sector
through two main approaches: (i) strengthening quality improvement systems; and (ii) modernizing cancer
management at selected tertiary facilities. This component aims to strengthen cross-cutting systems of
performance management and information technology that are pertinent across both sub-components,
and provides financing of goods, civil works, technical assistance, training and equipment.
Sub-component 3.1: Quality Improvement Systems (US$3.9 million)
This sub-component aims to strengthen quality improvement systems along three main mechanisms:
- Clinical practice guidelines and pathways. Under this component National clinical practice
guidelines are being developed, aligned to international evidence but closely linked with the HIF
budget envelope. Additional clinical pathways are being developed to ensure coverage of key
conditions that represent the main burden of disease in Serbia.
- Quality improvement support. Activities under this subcomponent provide funding for training
and TA, coordinated through AZUS, in order to provide targeted support to DZs to improve quality
of care for priority conditions.
- Improved information management. Activities under this subcomponent aim to improve capacity
for reporting and use of information on service quality and efficiency at key institutes involved in
these functions, namely the MoH, HIF and IPH.
Sub-component 3.2: Improve Cancer Management (US$18.5 million)
This sub-component supports the purchase and installation of six accelerators, together with associated
equipment and civil works, to increase the coverage and quality of radiation therapy cancer treatment at
specialized tertiary oncology centers. Health facilities preliminary identified as beneficiaries of the new
devices include the Institute for Oncology and Radiology of Serbia, Clinical Centre Kragujevac, Clinical
Centre Nis and Health Centre Kladovo. Technical assessment by the Bank confirmed that this additional
treatment capacity is needed to cope with current and projected patient volumes, particularly if cancer
screening programs were to scale up in the coming years. The accelerators are procured together with
extended warranties, to ensure four years of full-capacity operation and software updates. This
component also supports training and technical assistance to improve monitoring of patient outcomes,

including through strengthening the national cancer registry system. In addition, the Project support to
improve maintenance of medical equipment is expected to reduce “downtime” of existing accelerators,
which will also allow more patients to receive radiotherapy treatment.
Component 4: Monitoring, Evaluation, and Project management (US$ 3 million). This component
provides financing of day-to-day project management, operating costs, monitoring and evaluation,
including inter-alia translation, interpretation, equipment, supervision costs, staffing costs of the PIU,
M&E, studies and surveys, and incremental costs at the MoH has been provided. Also, study tours in
countries with similar reforms have been included.
1.2.1 Medical equipment for cancer treatment
Modern linear accelerators present standard equipment in radiotherapy centers worldwide. The
application of the latest scientific and technical-technological achievements in the modern medical
accelerator equipment is necessary in clinical practice in the radiotherapy of carcinoma. The main
components of the LINAC are: base, rotating tripod with the accelerator head’s, a colorimeter, therapeutic
table and laser system for the patient positioning.
Patient and medical staff safety is very important and is assured in several ways. According to the
national and international recommendations for protection against ionizing radiation that these devices
produce during their use, LINAC must be placed in a specially constructed room – bunker, with concrete
walls thick enough to adequately attenuate the primary radiation beam, as well as secondary photon
scattering. Safety of the staff operating the linear accelerator is also important. The radiation therapist
must turn on the accelerator from outside the treatment room. Because the accelerator only gives the
radiation when it is actually turned on, the risk of accidental exposure is extremely low.
The linear accelerators providing therapeutic energy of 15 MeV produce also a very strong ionized
radiation with photons with great penetrating power. For this reason, the space in which a therapeutic
accelerator is located must have excellent protection. The linear accelerator sits in a room with lead and
concrete walls so that the high-energy x-rays are shielded. Primary care protection is placed in order to
effectively attenuate the direct photon radiation, and secondary protection reduces the radiation that
exists inside the therapy room. Radiation doses for cancer treatment are measured in a unit called Gray
(Gy), which is a measure of the amount of radiation energy absorbed by 1 kilogram of human tissue.
Different doses of radiation are needed to kill different types of cancer cells.
While ensuring safety, it is necessary to assess the likelihood of radiation exposure factors, and
actual exposure. The fundamental and most effective principle of protection is projecting walls thick

enough. In order to reduce risks, investigation of neutron exposure in the use of electronic medical
accelerator is made from the very transport of neutrons to protection accelerator equipment, treatment
rooms with patients and medical staff. Quality control of the linear accelerator is also very important.
There are several systems built into the accelerator so that it will not deliver a higher dose than the
radiation oncologist has prescribed. However, an estimated radiation dose for the controlled area is 100
μSv and 20 μSv for surrounding public spaces on a weekly basis. Places where neutrons are produced or
absorbed present potential sources of residual radioactivity. A well designed protection against high-
energy photons and neutrons should be counted on. Neutron protection requires materials containing
hydrogen, while the anti- H materials required large air mass and atomic number. The materials widely
used for the protection are: ordinary and heavy (reinforced) concrete, lead, steel, or polyethylene wax,
earth and wood.
1.2.2 Scope of additional financing
Additional financing will ensure further improvement of cancer management. Proposed activities under
the AF and within the Subcomponent 3.2: Improve Cancer Management, are as follows:
1. The Serbian Comprehensive Cancer Management Strategy covers prevention, diagnostics and
treatment. Although efforts have been made in the past by the MoH, with support from the World Bank
and European Commission, to address screening and early detection of leading malignant diseases
(cervical, colon and breast cancer), no significant progress has been achieved to date. Diagnosed cancer
cases are predominantly stages III or IV. Comprehensive approach to cancer control is needed to improve
and align cancer prevention and enhance efficiency so as to (a) establish and strengthen early disease
detection system; (b) promote use of digital technologies in cancer registration and patient treatment
data collection, transfer, treatment decisions, and analytics against an internationally recognized format;
(c) institutionalize more vigorous health promotion activities; and (d) put in place appropriate
infrastructure and advanced treatment modalities for tertiary level cancer treatment, which hampers the
effectiveness and efficiency in the use of human and financial resources.
2. Improvement of National Coverage of Radiotherapy Services. Six linear accelerators (LINAC),

varying in technical specifications and requirements, and three CT-simulators have been procured for the
four oncology institutions in Serbia (Belgrade, Kragujevac, Nis and Kladovo) under the parent project and
full installation should be completed by March 2018. In parallel, the Government of Serbia has purchased
four LINACs from the budget aiming to achieve international standards for radiotherapy coverage.
About 11,000 people in the northern province of Vojvodina (VOI) are affected by cancer annually, 4,000 of
whom need radiation or combined chemotherapy and radiotherapy. On a monthly level, more than 200
patients for whom the oncological committee has indicated radiation therapy are registered in the list of
appointments. In September 2017, the waiting list for radiation therapy at the VOI included 368 patients.
Approximately 60 percent of patients from the waiting list are breast cancer patients followed by
gynecological and colorectal cancers. To date, VOI has not benefitted from the radiotherapy procurement.
It is proposed that retroactive financing will be considered for the procurement of the equipment for VOI
under the proposed AF.
To achieve full territorial radiotherapy coverage and provide equity, access and standardized quality of
cancer treatment across the country, the proposed AF would finance two new LINACS and rehabilitation
of the two bunkers for VOI. The VOI’s Radiotherapy Clinic has qualified staff and is fully equipped for new
accelerators. Due to Government’s prerogative to secure equity in access and quality of cancer treatment
throughout the country, this activity would be subject to retroactive financing.
Climate Change and Disaster. Given that this subcomponent will support the rehabilitation of two bunkers
for the LINACs, climate change and geophysical hazards (such as flood as in 2014) could impact the
structural integrity, materials, siting, longevity and overall effectiveness of the investments. However, this
is considered as low risk as climate and geophysical hazards, such as flood, are not likely to impact overall
project activities. Nevertheless, the planned works for the two bunkers will incorporate climate and
natural disasters resilience considerations (e.g., resilience to floods, extreme temperature increases, etc.).
3. Improvement of Timely Diagnostics in Oncology. While the original project has supported Serbia in
meeting international standards in treatment, the needs for diagnostics equipment have been put aside,
as the MoHs focus was on providing conditions for timely treatment and addressing waiting lists for cancer
treatment. Now that international standards in radiotherapy in Serbia will be met during the length of the
project (SSHP and AF), conditions will be in place for addressing issues of under-diagnostics and late
diagnostics. It is of utmost importance to increase the quality of diagnostics for timely and efficient cancer
management.

In 52.2 percent of the cases, the disease is diagnosed in an advanced stage, with regional and distant
metastases present. Such late diagnostics not only adversely affects treatment outcome, but increases the
health care system expenses as well due to requirement of applying more and costlier treatment options.
The latest data from the Institute of Public Health show that Serbia is among the countries with the lowest
number of CT scanners and MRIs. Improved and early diagnostics in oncology is important not only
because diagnosing and treating cancer at an early stage can save lives, but also because of its budgetary
implications. Fiscal impacts of such health care policy are also significant, having in mind that savings could
be achieved through reduced funds for high-cost oncology drugs. Such approach increases the quality of
care and efficiency in public spending on health. Providing opportunities for timely cancer treatment and
clearing waiting lists, thanks to the provision of LINACs, will create space for early, improved diagnostics
which calls for additional modern equipment (mainly MRI and scanners). The proposed AF could support
the MoH in addressing this issue provided that the MoH fulfill the following conditions of disbursements,
all satisfactory to the Bank: (i) adoption of a comprehensive National Cancer Strategy; (ii) adoption of a
Network Optimization Plan; and (iii) institutionalization of a sustainable Medical Equipment Maintenance
System.
The proposed AF would finance procurement of CT scanners and MRIs, but the precise number and
distribution of new diagnostic equipment will be subject to a comprehensive needs analysis. Procurement
of diagnostic equipment as well as the PET Center would be conditioned (conditions of disbursement) by
the implementation of a National Cancer Management Strategy, a Health Care Network Optimization Plan,
and the institutionalization of a medical equipment maintenance system for defined new high cost
equipment.
This sub-component would finance works, goods, technical assistance, and training
1.3 Objectives of the Environmental Management Framework Document

This Environmental Management Framework Document (EMFD) suggests general policies,
guidelines, codes of practice and procedures which will be implemented into the SSHP supported by WB.
The document defines the steps, processes and procedures for screening, as well as alternative analysis,
assessment, monitoring and management of the environmentally-related issues. In addition, the EMFD
analyzes environmental policies and legal regime of Serbia and safeguard policies of the WB; presents the
institutional and capacity assessment related to the environmental management; and describes the
principles, objectives and approach to be followed while designing site-specific environmental mitigation

measures. The EMFD should be used as a practical tool during program formulation, design,
implementation, and monitoring in the SSHP.
1.4 Approach and Methodology

The Environmental Management Framework Document outlines the environmental policy, legal,
and administrative framework for undertaking the project, presents the environmental baseline
information and potential environmental impacts and includes the range of available mitigation measures
that may be adopted, based on each particular situation. The EMFD describes how the potential
environmental impacts of the project will be managed during preparation and implementation periods.
The EMFD includes a blank EMP checklist (see Annex 1).
2. OPERATING REQUIREMENTS – DIAGNOSIS OF LEGAL AND

INSTITUTIONAL FRAMEWORK AND APPLICABLE SAFEGUARDS
2.1 Foreword
The legal, legislative and institutional framework for the prevention health care system and the
environmental protection in Republic of Serbia is founded on the Constitution of Serbia, which stipulates
the right to a healthy environment and the duty of all, in line with the law, to protect and enhance the
environment. Currently, the majority of these are harmonized with EU legislation. The list of currently
valid environmentally-related legislation is presented in Chapter 2.4 and 2.5 in EMFD.
2.2 Relevant information

The Ministry of Environmental Protection (MoEP) is the key institution in Republic of Serbia
responsible for formulation and implementation of environmental policy matters. The other aspects of
environmental management related to the environmental aspects of projects are dealt with several other
institutions, among which are Serbian Radiation Protection and Nuclear Safety Agency (SRPNSA), Institute
for Natural Protection (INP), Institute of Occupational Health of Serbia, and the Ministry of Construction,
Transport and Infrastructure . The Medicines and Medicals Devices Agency of Serbia (MMDAS) has an
important role in obtaining the necessary approval for putting on the market medical equipment.

2.3 EIA procedure in the Republic of Serbia
The Environmental Impact Assessment procedure (in the legal system of the Republic of Serbia) is
regulated by the Law on Environmental Impact Assessment, which is completely in line with European EIA
Directive 85/337/EEC. According to that Law, preparation of the Environmental Impact Assessment is not
required for the projects activities to be funded as a part of the Project, unless they are placed within or in
the vicinity of the nature or culture protected areas/objects. In such cases the Project Proponent is obliged
to submit so-called “Request for Decision about Need for Environmental Impact Assessment” (RDNEIA) to
the MoEP. Depending on the Ministry’s assessment of significance of potential environmental impacts of
the project, it is decided if there is a need (or not) to apply partial or full EIA procedure for the relevant
section of project. Additionally, since SSHP will be funded by WB, the requirements related to Operational
Policy OP 4.01 Environmental Assessment, will need to be observed. According to national Law on
Environmental Protection, Decree on establishing the List of Projects for which the Impact Assessment is
mandatory and the List of projects for which the EIA can be requested (2009), preparation of the
Environmental Impact Assessment is not required for the project related activities that are to be
undertaken within the existing hospital compounds, except for those that are under specific regime of
protection as a culture heritage or nature monument.
2.4 Other Relevant Government Policies, Act, Rules, Strategies and

Guidelines
The relevant legislative in Republic of Serbia for environmental protection and Health project are:
 The Constitution of Serbia (’’Official Gazette of RS’’, No. 98/06)

 Law of Health Care (’’Official Gazette of RS’’ No. 107/2005, 72/2009, 88/2010, 99/2010, 57/2011,
119/2012, 45/2013 - other laws, 93/2014, 96/2015 and 106/2015),
 Law on Medical Devices (’’Official Gazette of RS’’, No. 105/17)
 Law of Ionizing radiation and on Nuclear Safety (‘’Official Gazette of RS’’ No 36/09, 93/12),
 Rules on limits of exposure to ionizing radiation and measurements to assess the level of exposure
to ionizing radiation (Official Gazette RS, No. 86/11),
 Regulation on the limits of radioactive contamination of person, workplace and environment and
the methods of decontamination (Official Gazette RS, No 38/11),
 Law on Environmental Protection (“Official Gazette of RS” No. 135/04, 36/09, 72/09, 43/11 and
14/16),

 Law on Environmental Impact Assessment (“Official Gazette of RS” No. 135/04, 36/09),
 The Law on Waste Management (“Official Gazette of RS” No. 36/09, 88/10 and 14/16),
 The Law on Occupational Safety and Health (“Official Gazette of RS” No. 101/05, 91/2015 and
113/17 – other law),
 Law on Planning and Construction (“Official Gazette of RS” No. 72/09, 81/09, 56/10, 24/11,
121/12, 42/13, 50/13, 98/13, 132/2014 and 145/2014),
 Law on Nature Protection, (“Official Gazette of RS” No. 36/09, 88/10, 91/10 and 14/16),
Law on Strategic EIA (“Official Gazette of RS” No. 135/2004 and 88/2010), Regulations established on
the basis of the Law on EIA include the following:
 Decree on establishing the List of Projects for which the Impact Assessment is mandatory and the
List of projects for which the EIA can be requested (“Official Gazette of RS” No.114/08)
 Rulebook on the contents of requests for the necessity of Impact Assessment and on the contents
of requests for specification of scope and contents of the EIA Study (“Official Gazette of RS” No.
69/05)
 Rulebook on the contents of the EIA Study (“Official Gazette of RS” No. 69/05)
 Rulebook on the procedure of public inspection, presentation and public consultation about the
EIA Study (“Official Gazette of RS” No. 69/05)
 Rulebook on the work of the Technical Committee for the EIA Study (“Official Gazette of RS” No.
69/05)
 Law on confirmation of convention on information disclosure, public involvement in process of
decision making and legal protection in the environmental area (“Official Gazette of RS”, 38/09)
The parts related to this project are briefly summarized in sections 2.5.1 to 2.5.7.
2.4.1 The Constitution of Serbia
Within the Serbia’s Constitution it is stated that everyone shall have the right to a healthy
environment and the right to timely and full information about the state of the environment. Everyone,
especially the Republic of Serbia and Autonomous Provinces, shall be accountable for the protection of
the environment. Everyone shall be obliged to preserve and improve the environment.

2.4.2 Law on Health Care
Health care includes the implementation of measures for the preservation and improvement of
public health, prevention, early prevention and detection of diseases, injuries and other health problems
in timely and their effective treatment and rehabilitation. A citizen of the Republic of Serbia, as well as any
other person who has permanent or temporary residence in the Republic has the right to health care, in
accordance with the law, and the duty to protect and improve their health, health of other citizens, and
environmental conditions and working environment.
2.4.3 Law on Medical Devices
This Law regulates the conditions and procedures for issuing licenses for the marketing
authorization, or entry of drugs into the registers maintained by the Medicines and Medical Devices
Agency of Serbia (ALIMS), the production and trade of drugs and medical devices and monitoring in these
areas, operation of ALIMS and other issues relevant to the field of medicines and medical devices.
2.4.4 Law on Ionizing Radiation and on Nuclear Safety
This law prescribes measures to protect life, health and the environment from harmful effects of
ionizing radiation and nuclear safety, measures in all proceedings related to nuclear activities and defines
the conditions for conducting activities with ionizing radiation sources, nuclear materials and radioactive
management. It is forbidden to carry out the activities with ionizing radiation sources and nuclear
materials without prior approval by the Serbian Radiation Protection and Nuclear Safety Agency. The
measuring of radiation level and ensuring safety and security is an integral part of the technical
documentation for facilities that use or will use ionizing radiation sources, whose implementation ensures
that such facilities meet the prescribed level of protection of exposed persons, and the environment from
ionizing radiation.
2.4.5 Law on Environmental Protection
Law on Environmental Protection (LEP) is adopted in 2004. The LEP is currently the main
legislation relating to environment protection in Serbia. The Law on Environmental Protection is fully
harmonized with Council Directive 2003/105/EC, which amends Council Directive 96/82/EC on the control
of major-accident hazards involving dangerous substances (Seveso II Directive).
The main objectives of LEP are:
 Conservation and improvement of the environment; and
 Control and mitigation of pollution of the environment.
The main focuses of LEP are:

 Declaration of ecologically critical areas and restriction on the operations and processes, which
can or cannot be carried out/ initiated in the ecologically critical areas;
 Regulations in respect of vehicles emitting smoke harmful for the environment;
 Environmental Approval;
 Regulation of industries and other development activities‘ discharge permits;
 Promulgation of standards for quality of air, water, noise and soil for different areas for different
purposes;
 Promulgation of a standard limit for discharging and emitting waste; and
 Formulation and declaration of environmental guidelines.
To implement the Law on Environmental Impact Assessment, a government Decree determines

the list of projects for which an impact assessment is mandatory (2009) or may be required in
accordance with the relevant EU directives 97/11/EC and 337/85/EEC. Public participation is also
envisaged in all environmental impact assessment stages. All subsidiary regulations were adopted in 2005.
Public information and public participation in decision-making have been introduced in line with EU
Directive 2003/35/EC on public participation.
2.4.4 Law on Environmental Impact Assessment
The Law on EIA (LOEIA) provides categorization of industries and projects and identifies types of
environmental assessment required against respective categories of industries or projects. The Law
covers, among others:
 Declaration of ecologically critical areas;

 Classification of industries and projects into 2 categories;
 Procedures for issuing the Final Environmental Approval (FEA); and
 Determination of environmental standards.
LOEIA also contains the procedures for obtaining FEA from the Department of EIA for different
types of proposed industries or projects.

2.4.5 The Law on Waste Management
The Law on Waste Management, which is harmonized with all relevant EU directives, has been
adopted in 2009 and contains provisions that relate to electric and electronic waste.
2.4.6 The Law on Occupational Safety and Health
This Law regulates the occupational safety and health system in Serbia. By harmonizing this law
with the ratified International Labor Organization conventions and EU Framework Directive 89/391/EEC,
as well as special directives derived from the Framework Directive, all guidelines originating from them
have been accepted in a form adjusted to national conditions. Apart from this Law, the regulatory
framework of the occupational safety and health system is integrated by several sub-acts.
2.4.7 The Law on Planning and Construction
This law is regulated with the terms and manner of spatial development and use construction land
and construction of buildings; supervision over implementation of this legislation and inspection, the
second issue of importance for the development of space, editing and use of land for construction.
2.5 World Bank’s Environmental Safeguard Policy

Following is the short summary of several relevant Banks’ Safeguards Policies. The full texts could
be found at the WB web site.
2.5.1 OP/BP 4.01 Environmental Assessment
The Bank requires Environmental Assessment (EA) of projects proposed for Bank support to
ensure that they do not have, or mitigate potential negative environmental impacts. The EA is a process
whose breadth, depth, and type of analysis depend on the nature, scale, and potential environmental
impact of the proposed project. The EA evaluates a project's potential environmental risks and impacts in
its area of influence; examines project alternatives; identifies ways of improving project selection,
planning, design, and implementation by preventing, minimizing, mitigating, or compensating for adverse
environmental impacts and enhancing positive impacts; and includes the process of mitigating and
managing adverse environmental impacts throughout project implementation. The EA takes into account
the natural environment (air, water and land); human health and safety; social aspects; and trans-
boundary and global environmental aspects. The Borrower is responsible for carrying out the EA and the
Bank advises the Borrower on the Bank‘s EA requirements.

The Bank classifies the proposed projects into three major categories, depending on the type,
location, sensitivity, scale of the project and the nature and magnitude of its potential environmental
impacts:
 Category A: The proposed project is likely to have significant adverse environmental impacts that
are sensitive, diverse, or unprecedented. These impacts may affect an area broader than the sites
or facilities subject to physical works.
 Category B: The proposed project‘s potential adverse environmental impacts on human
population or environmentally important areas-including wetlands, forests, grasslands, or other
natural habitats- are less adverse than those of Category A projects. These impacts are site
specific; few if any of them are irreversible; and in most cases migratory measures can be
designed more readily than Category A projects,
 Category C: The proposed project is likely to have minimal or no adverse environmental impact
According to the World Bank standards, SSHP is categorized as project belonging to environmental
category B, due to activities that are to be undertaken under Project Component 3.
2.5.2 OP/BP 4.04 Natural Habitats
The policy deals with activities to be executed near or within protected natural habitats. Bank
supports the protection, maintenance, and rehabilitation of natural habitats and their functions in its
economic and sector work, project financing, and policy dialogue. The full text of the policy is available at
the WB web site.
2.5.3 OP/BP 4.11 Physical Cultural Resources
The policy deals with the protection of physical cultural heritage. Physical cultural resources are
defined as movable or immovable objects, sites, structures, groups of structures, and natural features and
landscapes that have archaeological, paleontological, historical, architectural, religious, aesthetic, or other
cultural significance. Physical cultural resources are important as sources of valuable scientific and
historical information, as assets for economic and social development, and as integral parts of a people's
cultural identity and practices. The full text of the policy is available at the WB web site.
2.5.4 OP/BP 4.36 Forestry
The policy envisages the protection of forests through consideration of forest-related impact of all
investment operations, ensuring restrictions for operations affecting critical forest conservation areas, and
improving commercial forest practice through the use of modern certification systems. In the process of

forest conservation interventions, especially the local people, the private sector and other pertinent
stakeholders should be consulted.
In general, the Policy aims at reducing deforestation and enhancing the environmental and social
contribution of forested areas. The full text of the policy is available at the WB web site
2.5.5 OP/BP 4.12 Involuntary Resettlement
This policy is aiming on assisting the displaced persons in their efforts to improve or at least
restore their standards of living, which may be adversely affected by the project related activities. The full
text of the policy is available at the WB web site.
2.5.6 IFC Environmental, Health and Safety Guidelines
The Environmental, Health and Safety (EHS) Guidelines of the International Finance Corporation
(IFC), 2008 are the safeguard guidelines for environment, health and safety for the development of the
industrial and other projects. They contain performance levels and measures that are considered to be
achievable in new facilities at reasonable costs using existing technologies. The full text of the policy is
available at the WB web site. Application of EHS Guidelines is obligatory for all Bank financed activities.
Whenever EHS Guidelines and requirements of national legislation differ, the more stringent ones will be
applied.
3. POTENTIAL ENVIRONMENTAL IMPACTS
During the implementation of Project Component 3, including additional financing of activities

under the subcomponent 3.2, the following activities should be undertaken:
- Assessment of the current network of accelerators compared to current and anticipated patient
load, and optimal organization of cancer care and treatment based on current international the best
practices,
- Evaluation of necessary equipment, type and quantity,
- Selection of location of specialized tertiary hospitals, where the purchased equipment will be
situated and installation of the new equipment,
- Selection of the old equipment that will be replaced,

- Preparation, planning and construction of new objects,
- Construction of new objects where equipment will be located, or rehabilitation/upgrade of the
existing facilities,
- Procurement, transport of the equipment, obtaining the necessary approval and technical
documents (by the Medicines and Medicals Devices Agency of Serbia, Serbian Radiation Protection and
Nuclear Safety Agency and Ministry of Construction and Urban Planning, Ministry of Environmental
Protection),
- Replacing the old equipment with the new one,
- The storage of old equipment, the utilization of equipment, primary disposal and the storage.
The Project is rated environmental category B. Most of the Project Components are
environmentally neutral; however, Component 3 will include installation of the medical equipment into
already existing, purpose-built facilities (bunkers) that will be modified, to suit specifications of the new
equipment. Environmental Management Framework (EMF) is being prepared for the activities within the
additional financing of subcomponent 3.2. The related civil works will be undertaken within existing
hospitals and medical centers in VOI , and are not expected to have any significant negative environmental
impact. The issues related to this type of activities include noise, dust, vibrations, and management of
construction waste during civil engineering activities - which could be successfully managed and mitigated
by application of good engineering practices. Specific issues that will also be taken care of relate to
management of the site (as hospitals must continue operating during the execution of works), and health
and safety of population. In some cases, the presence of asbestos, lead or other medical or possibly
hazardous waste (if found during rehabilitation works), may require specific handling procedures, which
will be defined in site-specific EMPs that are to be prepared for each facility. For guidance and more
specific information on potential impacts and possible mitigation measures, please refer to Sample
Environmental Checklist, which is attached as an Annex to this EMF.
During the Project preparation it will be confirmed whether any of the buildings chosen for
rehabilitation are designated cultural property. As provided for in the EMF, in these cases the site-specific
EMPs will include clauses related to heritage protection and conservation. The civil engineering works will
have to be reviewed and approved by competent national cultural heritage institutions.
The Project may also fund construction of new facilities (bunkers) to house linear accelerators.
These facilities will be constructed within the existing hospital buildings (without change of footprint), or
in adjacent buildings – within the existing hospital compounds.

Linear accelerators for treatment of cancer do not contain any radioactive substances, but instead
use electricity to generate either high-energy x-rays or accelerated electrons that can be precisely
targeted on cancerous tissue. When not in operation, no harmful radiation is generated, although the
treatment room itself requires shielding of the walls, doors, and ceiling to prevent escape of scattered
radiation during the radiotherapy treatment. The solution applied is similar to the arrangement used to
protect staff using diagnostic x-ray equipment, although the higher energy of therapy beams requires a
radiation vault (bunker) with thick concrete walls (up to 2.5 m) to provide adequate radiation shielding.
The impact specifically to be taken into account also include the potential radiation source’s
influence of equipment, as well as potential influence on waste management during the entire cycle - from
procurement to warehousing. The potential environmental impact mitigation measures must also follow
the same stages:
 From procurement to installation,
 Replacing old equipment with new,
 Preparation, planning and construction of new objects
 The storage of old equipment,
 The utilization,
 Primary disposal, and
 The storage.
The main considerations while dealing with waste management are outlined below:
From procurement to installation

The equipment is considered as product until the installation. The product will be packed by the
manufacturer’s standards. After unpacking, the equipment will be installed according to the
manufacturer's instructions, which will be translated to the Serbian language by the competent authority.
In this step, it is packaging waste that will be generated, not the hazardous waste, according to Directive
2008/98/EC and national law and by-law, and will be treated as secondary raw material or will be
recycling.
Replacing old equipment with the new one

In this step, the old equipment has to be declared as waste, in any of the following technical
reasons: devices limitation, inability to repair, radiation construe as the risks to the environment and
human health, etc. In these circumstances, it is necessary to choose the appropriate object or indoor

facility where it is possible to store these devices. Then, the waste’s owner (the Institution that is the
owner of equipment) must engage an accredited laboratory for waste classification and characterization,
as well as to prepare the Waste Management Plan (WMP), in according to national law and by-laws. The
institution is obligated to find a temporary storage location for its waste for the period of 12 months. The
primary waste disposal must be performed inside the object for temporary storage, in according to
national legislative and Directive EU.
Construction of new objects or upgrade of existing facilities

In accordance to national and international recommendations (International recommendation for
linear accelerator) for protection against ionizing radiation, preparation for planning and designing the
new objects or for rehabilitation/upgrade of the existing facilities is necessary. In this case the project will
use only the recommended materials for isolation of primary and secondary radiation sources, and will
use other specific recommendations and procedures for the projects and specific standards for the
objects, and will apply the relevant environmental mitigation measures, as indicated in this EFD, and
environmental checklist, and relevant Serbian legislation, and World Bank EHS Guidelines - to reduce or
avoid negative environmental impact and/or negative impact on human health and occupation safety. The
full permitting and licensing process, as required by the national and international standards, will be
observed and subject to review and No Objection by the Bank. Whenever the standards of national and
international practices differ, more stringent ones will be applied as a rule. For the each facility, the
environmental, health and safety standards, and relevant mitigation measures, will be part of the site-
specific EMPs, to be prepared using this EMF as guidance.
The storage of old equipment

During the 12 months, the waste’s owner will separate the waste on different types of waste, such
as electronic/electric, and any other type of waste or secondary raw materials, materials for recycling, etc.
Also, the owner will engage an authorized waste operator for final waste disposal.
The utilization
At the time when the device is switched to normal operating mode, there will be possibility for a
potential environment impact, which will be in accordance to national and international recommendations
(International recommendation for linear accelerator) for protection against ionizing radiation. At this
stage, there will also be a possibility for potential impact on human health (machine operators and users).
The potential for negative impact will exist during operation of the accelerator equipment, in case that

Serbian standard for ionizing radiation and nuclear safety is not adequately applied. The Project will, as a
part of the design and permitting process, ensure for each piece of equipment that relevant standards are
applied and design is certified by the Institute of Occupational Health of Serbia. Additionally, the Word
bank EHS Guidelines and ILO Code of Practice “Radiation Protection of Workers (Ionizing Radiation”)” will
apply to all sites under Project Component 3. As a rule, whenever the Serbian and World Bank standards
and guidance documents differ on environment, health and safety, the more stringent ones will be
applied.
Ionizing radiation that occurs while using the equipment is a major operational concern.
Accordingly, the table (Table 1: Review comparison between the World Bank EHS Guidelines and Serbian
legislation for the ionization radiation, ANNEX 2) shows review comparisons between Rules on limits of
exposure to ionizing radiation and measurements to assess the level of exposure to ionizing radiation
(Official Gazette RS, No. 86/11 on 18.11.2011.) from Serbian legislation and Radiation protection of worker
– ionized radiation (International Labor Organization 1987, ISBN 92-2-105996-0) from World Bank EHS
Guidelines, their compliance, as well as the conditions under which one of them applies in the Project.
According to all relevant information and comparison made, it can be concluded that there are no
substantial differences between the standards, because Serbian legislation adopted the recommendations
of the International Commission on Radiological Protection (ICRP), the standards of International Agency
for Atomic Energy (IAAE) and the best international practices in this area.
For the reference, both Serbian and World Bank standards for safety from ionizing radiation, and
their comparison, are attached in Annex 2 and Annex 3.
Primary disposal
This step is identical with the stage of replacing old equipment with the new devices.
The storage
This step is identical with the step of storage of old equipment.
4. ENVIRONMENTAL MANAGEMENT APPROACH

The WB ECA safeguards team has developed an alternative to the Environmental Management
Plan (EMP) format document for the objects that presented a low-risk topology, such as hospital
rehabilitation activities. The EMP is in the form of checklist-type format, which has been development as

‘’sample of good practice’’ and designed as ‘’user friendly’’ document. It is compatible with WB safeguard
requirements. The blank format of the sample checklist is attached in the Annex of this document. The
EMP-checklist has following items:
 Part 1 presents the “site passport”, which describes the sub-project specifics in terms of physical
location, the institutional and legislative aspects, the restoration works, inclusive of the need for a
capacity building program and description of the public consultation process. This section could be up
to two pages long. Attachments for additional information can be supplemented if needed.
 Part 2 includes the environmental and social screening in a simple Yes/No format followed by
mitigation measures for any given activity.
 Part 3 is a monitoring plan for activities during project construction and implementation. It retains the
same format required for standard WB EMPs.
The EMP checklist and particularly parts 2 and 3 must be included in the bidding documents for the
prospective works.
4.1 Application of the EMP-Checklist and EMF on the Project

The Project implementation team will have to ensure adequate application of the EMP – checklists
for all activities that may have an environmental impact. This particularly applies, but is not limited to,
activities under Component 3. For the upgrade of the existing facilities, there will be a need for the EMP
Checklist alone, but for the new bunkers/facilities or equipment, the Project’s implementation team will
prepare the more detailed Environmental Mitigation and Monitoring Plan (EMP) – fully compliant with the
WB OP4.01, that must include, as its integral part, the EMP Checklist. The EMP-checklist will be
implemented in three phases:
1. Typical environmental issues listed in the checklist and likely to be encountered in the sub-
projects will be identified, corresponding requirements of the Republic of Serbia or WB guidelines
outlined, and steps to fulfill these requirements are explained in a practical and easy-to-follow
manner. The latter will include attachment of sample permit and license application forms, listing
of relevant authorities in correct order whom sub-project proponents and or contractors need to
contact for each of the typical environmental issues. Furthermore, monitoring requirements as
per Republic of Serbia or WB guidelines will be presented for each issue. These documents will be

made available to potential sub-project applicants in printed form as well as electronically on the
project website.
2. The contract with the selected bidder will highlight the contractor’s obligations for environmental
measures. Additionally, the completed tabular EMP will be attached to the contract and,
analogous to all technical and commercial terms, signed by the contract parties.
3. Works implementation phase. The environmental specialist will check environmental compliance
on site using Part 3 of the EMP-checklist alongside other quality criteria.
4.2 Monitoring and Reporting of Component 3 related activities

Part 3 of the EMP-checklist will be developed site specifically and in necessary detail, defining
clear criteria and parameters which will be included in the works contracts, reflect the status of
environmental practice on the construction site and can be observed/measured/ quantified/verified by
the environmental specialist during the execution of relevant activities.
Such parameters and criteria include workers’ use of personal protective equipment on the site,
noise and dust generation and prevention, protection of the ionized radiation, amount of water used and
discharged by site, presence of proper sanitary facilities for workers, waste collection of separate types
(electrical/electronic waste, packaging waste, foils, mineral waste, wood, metals, plastic, hazardous waste,
e.g. asbestos, paint residues), waste quantities, proper organization of disposal pathways and facilities, or
reuse and recycling wherever possible.
Specific issues that will also be taken care of relate to management of the site (as hospitals must
continue operating during the execution of works), and health and safety of staff and population.
The documented compliance with the environmental checklist, or EMP, as relevant, will be a
condition for full payment of the contractually agreed remuneration, the same as technical quality criteria
or quantity surveys. To assure a degree of leverage on the contractor’s environmental performance an
appropriate clause will be introduced in the works contracts, specifying penalties in case of
noncompliance with the contractual environmental provisions, e.g. in the form of withholding a certain
proportion of the payments, its size depending on the severity of the breach of contract. For extreme
cases a termination of the contract shall be contractually tied in.

4.3 Reporting of the Project Related Activities
The requirements for undertaking and reporting on the Project in respect to environmentally-
related activities will include:
(i) preparation of draft site-specific EMPs and checklists, as appropriate, for each specific
location/hospital, by the Project Implementation Team;
(ii) review and approval of site-specific EMPs and checklists by the Bank’s team;
(iii) inclusion of site-specific EMP and checklists as a part of the Bidding Documents, and
subsequent contract;
(iv) execution of EMP-related measures by the respective contractor(s);
(v) monitoring and reporting of compliance with EMP and checklist-related measures by
supervising engineer/environmental specialist (to the Project Implementation Team);
(vi) reporting on compliance with EMP to the Bank (by the Project Implementation Team)
5. PUBLIC CONSULTATION
Draft EMF document has been prepared by SSHP Team under the Ministry of Health during
January 2018. EMFD has been prepared in order to ensure application of the good environmental
practices and project compliance with the requirements of the World Bank and national legislation. The
objectives for additional financing have not been changed in accordance to the objectives stated in parent
project, and thus preparation of EMFD for additional financing has been based on the EMF Document
developed in 2013 for the purpose of the parent project. On January 25, 2018 SSHP/MoH announced
Public Consultations for the general public, bodies and organizations interested in EMFD for the Project.
Public and other interested parties and organizations were invited to participate in process of public
consultation on draft EMF document. Prior to announcement in the newspapers, the EMFD was published
on Ministry of Health web sites. Hard copy of EMFD was also available at the premises of SSHP, at DZ
„Savski venac“, Pasterova St. 1, Belgrade, within 3 days starting from January 25, 2018.
Public Consultation and presentation of EMF document was held in the in the DZ „Savski Venac“,
on January 30, 2018, from 10:00 AM to 11:30 AM. In total three (3) participants attended the public
consultation, of which two (2) were representatives of respective institutions and one (1) was citizen
representing interested public. There were no comments regarding the advertised EMF Document at the
public consultation, and the participants supported the entire health care reform project with the
emphasis on the procurement of medical equipment for the treatment and early diagnosis of cancer.
More information is attached in Annex 5.
6. IMPLEMENTING ARRANGEMENTS
An Environmental Management Framework (EMF) Document, including a sample Environmental

Management Plan (EMP)/Checklist was prepared for the Project. Site specific EMPs/Checklists will be
prepared during the subsequent phases, when the locations of investments are finalized. EMPs will
become part of the bidding documents and resulting contracts.
Monitoring and reporting on contractor’s compliance with site-specific EMPs on the proposed
Project will be undertaken on a monthly basis by the supervising engineer/environmental specialist and
reports sent to the Project Implementation Team (PIT). Reporting from PIT to the Bank will be undertaken
at least twice per year, and more frequently in case of particular issues or problems. Review of the
environmental compliance monthly reports and reality check on sample sub-projects will be undertaken
by the Bank’s safeguards specialist at least once per year, during the regular implementation support
missions, and more often in case of specific issues/needs.
The requirements for the environmentally-related activities under the Project will include:
(i) preparation of draft site-specific EMPs by the Project Implementation Team;
(ii) review and approval of site-specific EMPs by the Bank’s team;
(iii) inclusion of site-specific EMP as a part of the Bidding Document, and subsequent contract;
(iv) execution of EMP-related measures by the respective contractor(s);
(v) monitoring and reporting of compliance with EMP-related measures by supervising
engineer/environmental specialist (to the Project Implementation Team);
(vi) reporting on compliance with EMP to the Bank (by the Project Implementation Team).

ANNEX 1: Draft Format for EMP/EMF for Construction and Rehabilitation
Activities for ECSHD Projects
PART 1: INSTITUTIONAL & ADMINISTRATIVE

Country
Project title
Scope of project and
activity
Institutional WB Project Management Local Counterpart and/or Recipient
arrangements (Project
(Name and contacts) Team
Leader)
Implementation Safeguard Local Counterpart Local Inspectorate Contactor

arrangements Supervision Supervision Supervision
(Name and contacts)
SITE DESCRIPTION
Name of site
Describe site location Attachment 1: Site Map [ ]Y [ ] N
Who owns the land?
Geographic description
LEGISLATION
Identify national &
local legislation &
permits that apply to
project activity
PUBLIC CONSULTATION
Identify when / where
the public consultation
process took place
INSTITUTIONAL CAPACITY BUILDING

Will there be any [ ] N or [ ]Y if Yes, Attachment 2 includes the capacity building program
capacity building?

PART 2: ENVIRONMENTAL /SOCIAL SCREENING
Will the site activity Activity Status Additional references
include/involve any A. Building rehabilitation [ ] Yes [ ] No See Section B below
of the following: B. New construction [ ] Yes [ ] No See Section B below
C. Individual wastewater treatment system [ ] Yes [ ] No See Section C below
D. Historic building(s) and districts [ ] Yes [ ] No See Section D below
E. Acquisition of land1 [ ] Yes [ ] No See Section E below
F. Hazardous or toxic materials2 [ ] Yes [ ] No See Section F below
G. Impacts on forests and/or protected areas [ ] Yes [ ] No See Section G below
H. Handling / management of medical waste [ ] Yes [ ] No See Section H below
ACTIVITY PARAMETER MITIGATION MEASURES CHECKLIST
A. General Notification and Worker Safety (a) The local construction and environment inspectorates and communities have been notified of upcoming activities
Conditions (b) The public has been notified of the works through appropriate notification in the media and/or at publicly accessible
sites (including the site of the works)
(c) All legally required permits have been acquired for construction and/or rehabilitation
(d) All work will be carried out in a safe and disciplined manner designed to minimize impacts on neighboring residents
and environment.
(e) Workers’ PPE will comply with international good practice (always hardhats, as needed masks and safety glasses,
harnesses and safety boots)
(f) Appropriate signposting of the sites will inform workers of key rules and regulations to follow.
B. General Air Quality (a) During interior demolition use debris-chutes above the first floor
Rehabilitation (b) Keep demolition debris in controlled area and spray with water mist to reduce debris dust
and /or Construction (c) Suppress dust during pneumatic drilling/wall destruction by ongoing water spraying and/or installing dust screen
Activities enclosures at site
(d) Keep surrounding environment (side walks, roads) free of debris to minimize dust
(e) There will be no open burning of construction / waste material at the site
(f) There will be no excessive idling of construction vehicles at sites
Noise (a) Construction noise will be limited to restricted times agreed to in the permit
(b) During operations the engine covers of generators, air compressors and other powered mechanical equipment should be
closed, and equipment placed as far away from residential areas as possible
Water Quality (a) The site will establish appropriate erosion and sediment control measures such as e.g. hay bales and / or silt fences to
prevent sediment from moving off site and causing excessive turbidity in nearby streams and rivers.
Waste management (a) Waste collection and disposal pathways and sites will be identified for all major waste types expected from demolition
and construction activities.
(b) Mineral construction and demolition wastes will be separated from general refuse, organic, liquid and chemical wastes
by on-site sorting and stored in appropriate containers.
(c) Construction waste will be collected and disposed properly by licensed collectors
(d) The records of waste disposal will be maintained as proof for proper management as designed.
(e) Whenever feasible the contractor will reuse and recycle appropriate and viable materials (except asbestos)
1
Land acquisitions includes displacement of people, change of livelihood encroachment on private property this is to land that is purchased/transferred and affects
people who are living and/or squatters and/or operate a business (kiosks) on land that is being acquired.
2
Toxic / hazardous material includes and is not limited to asbestos, toxic paints, removal of lead paint, etc.
ACTIVITY PARAMETER MITIGATION MEASURES CHECKLIST
C. Individual wastewater Water Quality (a) The approach to handling sanitary wastes and wastewater from building sites (installation or reconstruction) must be
treatment system approved by the local authorities
(b) Before being discharged into receiving waters, effluents from individual wastewater systems must be treated in order to
meet the minimal quality criteria set out by national guidelines on effluent quality and wastewater treatment
(c) Monitoring of new wastewater systems (before/after) will be carried out
D. Historic building(s) Cultural Heritage (a) If the building is a designated historic structure, very close to such a structure, or located in a designated historic
district, notify and obtain approval/permits from local authorities and address all construction activities in line with
local and national legislation
(b) Ensure that provisions are put in place so that artifacts or other possible “chance finds” encountered in excavation or
construction are noted, officials contacted, and works activities delayed or modified to account for such finds.
E. Acquisition of land Land Acquisition (a) If expropriation of land was not expected and is required, or if loss of access to income of legal or illegal users of land
Plan/Framework was not expected but may occur, that the bank task Team Leader is consulted.
(b) The approved Land Acquisition Plan/Framework (if required by the project) will be implemented
F. Toxic Materials Asbestos management (a) If asbestos is located on the project site, mark clearly as hazardous material
(b) When possible the asbestos will be appropriately contained and sealed to minimize exposure
(c) The asbestos prior to removal (if removal is necessary) will be treated with a wetting agent to minimize asbestos dust
(d) Asbestos will be handled and disposed by skilled & experienced professionals
(e) If asbestos material is be stored temporarily, the wastes should be securely enclosed inside closed containments and
marked appropriately
(f) The removed asbestos will not be reused
Toxic / hazardous waste (a) Temporarily storage on site of all hazardous or toxic substances will be in safe containers labeled with details of
management composition, properties and handling information
(b) The containers of hazardous substances should be placed in an leak-proof container to prevent spillage and leaching
(c) The wastes are transported by specially licensed carriers and disposed in a licensed facility.
(d) Paints with toxic ingredients or solvents or lead-based paints will not be used
G. Affects forests and/or Protection (a) All recognized natural habitats and protected areas in the immediate vicinity of the activity will not be damaged or
protected areas exploited, all staff will be strictly prohibited from hunting, foraging, logging or other damaging activities.
(b) For large trees in the vicinity of the activity, mark and cordon off with a fence large tress and protect root system and
avoid any damage to the trees
(c) Adjacent wetlands and streams will be protected, from construction site run-off, with appropriate erosion and sediment
control feature to include by not limited to hay bales, silt fences
(d) There will be no unlicensed borrow pits, quarries or waste dumps in adjacent areas, especially not in protected areas.
H. Disposal of medical Infrastructure for medical (a) In compliance with national regulations the contractor will insure that newly constructed and/or rehabilitated health
waste waste management care facilities include sufficient infrastructure for medical waste handling and disposal; this includes and not limited to:
 Special facilities for segregated healthcare waste (including soiled instruments “sharps”, and human tissue or
fluids) from other waste disposal; and
 Appropriate storage facilities for medical waste are in place; and
 If the activity includes facility-based treatment, appropriate disposal options are in place and operational

PART 3: MONITORING PLAN
Phase What Where How When Why Cost Who
(Is the parameter to be (Is the parameter to be (Is the parameter to be (Define the frequency / or (Is the parameter being (if not included in (Is responsible for
monitored?) monitored?) monitored?) continuous?) monitored?) project budget) monitoring?)
During activity
implementation
During activity
supervision

ANNEX 2: Table 1: Review comparison between the World Bank EHS Guidelines and Serbian legislation for the
ionization radiation
Order Rules on limits of exposure to ionizing radiation and measurements to assess the Radiation protection of worker – ionized radiation, International Labor Organization
Number level of exposure to ionizing radiation, Official Gazette RS, No. 86/11 on 18.11.2011 1987,
ISBN 92-2-105996-0
1 Radiation risk for the full body or individual organs is determined via the effective Primary dose limits are individual-related values that apply to the annual doses
dose or tissue equivalent doses and the corresponding likelihood ratios adopted by received by worker from radiation sources related to work. These are as follows:
the International Committee for Radiation Protection: 2007 Recommendations of  Limit for the annual effective dose equivalent – 50 mSv,
the International Commission on Radiation Protection Publication No. 103 (The  Limit for annual dose equivalent in any organ or tissue (expect lens of the
2007 Recommendations of the International Commission on Radiological Protection, eye) – 500 mSv, and
ICRP Publication 103).  Limit for annual dose in the lens of the eye – 150 mSv.
The dose equivalents indicated above are the mean dose equivalent over the organ
The equivalents dose for the exposure limit of individual organs professionally or tissue. In the case of skin, the dose equivalent resulting from skin contamination is
exposed persons are: average over 100 cm2, but if the contamination is very uneven, and is suspected to
 the lens of the eye 150 mSv / year; arise from an unplanned exposure, the dose equivalent should be averaged over 1
 the skin of 500 mSv / year (refer to the equivalent dose averaged over the cm2. In the case of external exposure of the skin, the dose equivalent recorded by
surface of any part of skin the size of 1 cm 2, which is exposed to ionizing one or few dosimeters is deemed to represent the dose to the skin. The effective
radiation); dose equivalent is the quantity defined in the glossary at the end of this code.
 the extremities (hands, forearms, feet and ankles) 500 mSv / year.
For the purpose of assessing the radiation safety of professionally exposed persons,
the risk is descriptively classified in the following way:
1. large - estimated annual effective dose greater than 20 mSv ;
2. increased - the estimated annual effective dose greater than 6 mSv ;
3. moderate - the estimated annual effective dose greater than 1 mSv, and
4. negligible - the estimated annual effective dose less than or equal to 1 mSv
.
The effective dose is professionally exposed persons:
1. very high, if it is greater than 50 mSv for a year ;
2. high, if it is greater than 20 mSv for a year;
3. increased, if it is greater than 6 mSv for a year;
4. low, if it is less than or equal to 6 mSv for a year;
5. very low, if it is less than or equal to 2 mSv for a year;
6. negligible if it is less than or equal to 1 mSv for a year.

The effective dose of the population :
1. increased , if greater than 1 mSv for a year;
2. low, if it is greater than 0.3 mSv for a year;
3. very low, if it is less than or equal to 0.03 mSv for a year;
4. negligible if it is less than or equal to 0.01 mSv for a year.
Limit of effective dose for occupational exposed persons is 100 mSv in five
consecutive years (mean 20 mSv per year), with the additional restriction that in any
year an effective dose does not specify the value of 50 mSv.
Limit of effective dose refers to the sum of external exposure dose for a defined
period of time and the expected effective dose of internal exposure from
radionuclides entered the body in the same period.
2 Professionally exposed persons are classified according to operating conditions and For the purpose of this code there are two classes of working conditions for workers
levels of exposure to ionizing radiation in two following categories: engaged in radiation work:
1 Category A: Persons who are professionally employed in a controlled area and one  Working Condition A – where the annual exposures might exceed three-
that can receive an effective dose greater than 6 mSv per year or an equivalent dose tenths of the dose limits (point 1),
greater 3/10 of the prescribed dose limits for individual organs of occupationally  Working Condition B – where it is the most unlikely that the annual
exposed persons; exposures will exceed three tenths of the dose limits.
2 Category B: Persons who professionally or occasionally work in the supervised area The employer should make provisions to ensure that a pregnant woman does not
or occasionally in a controlled area and that the effective dose received by less than work under Working Condition A. There is a risk of inducing mental retardation
6 mSv per year. confined to a limited period of pregnancy makes it necessary that no substantial
irregularities to the dose rate occur for pregnant women working under Working
Condition B.
It may be convenient for radiation control purposes to classify workers engaged in
radiation work according to their exposure condition.
The employer should, with the advice of the radiation protection officer classify
workers as:
 Workers engaged in radiation work A: these are radiation workers working
under Working Condition A,
 Workers engaged in radiation work B: these are radiation workers working
under Working Condition B.
The employer should keep the classification of workers engaged in radiation work
under review to accommodate changes in working practices
3 The professional exposure is prohibited for the person younger than 16 years. No person under the age of 16 should be considered to be a worker engaged in
radiation work for the purpose of this code.
For the persons under the age of 18 is prohibited in the control zone, expect during No worker, student, apprentice or trainee under the age of 18 should be allowed to
the training and regular education under mandatory supervision engage in radiation Working Condition A, such person may only, therefore, work in
Working Condition B.
4 Occupationally exposed persons must meet health requirements and shall to carry The employer should provide health surveillance of workers engaged in radiation
out a medical examination prior to appointment, at work, in the case of accident, if work and ensure that all assessments to protect the health of workers are carried
necessary, upon cessation of the nuclear facility or source ionizing radiation. Medical out. Such health surveillance of workers engaged in radiation work should be based

examinations of persons referred to is a health institution that it meets the on the general principles of occupational health.
requirements prescribed by the regulations governing the health protection. (Law of Health surveillance for normal condition of work should include:
ionized)  Health assessment appropriate to the specific task to be performed, before
Evaluation of external radiation exposure levels of professionally exposed persons is the worker begins the assignment,
provided by personal dose equivalents measured by passive dosimeters personally  Periodic health surveillance during the assignment,
and/or results of measuring of intensity of the ambient dose equivalent in the  Special health surveillance when needed and as prescribed by the
workplace according to the methodology (Appendix 2). Measurement of personal competent authority for workers engaged in radiation work A,
dose equivalent using passive personal dosimeters for the full body and limbs to  Assessment when a pregnancy is reported,
assess the level of exposure to ionizing radiation is carried out at least once a month  Other health assessments as required by the competent authority.
for workers of category A and at least once every three months for workers category
B.

ANNEX 3: Rules on limits of exposure to ionizing radiation and measurements to
assess the level of exposure to ionizing radiation, Official Gazette RS, No. 86/11 on
18.11.2011. and Radiation protection of worker – ionized radiation, International
Labor Organization 1987, ISBN 92-2-105996-0
http://www.srbatom.gov.rs/srbatom/doc/vazeca_akta/RULEBOOK%20ON%20LIMITS%20OF%20EXPOSURE
%20TO%20IONIZING%20RADIATION%20AND%20MEASUREMENTS%20FOR%20ASSESSMENT%20THE
%20EXPOSURE%20LEVELS.pdf

ANNEX 4: Proposed components of the Additional Financing
COMPONENT 1: Improvement of Health Financing (Euro 3.0 million)

This component will comprise two sub-components in addition to supporting citizen engagement (CE)
activities related to patient rights, including the development and implementation of a strategy and action
plan to: (i) improve systems aimed at protecting patient rights (e.g. designated patient rights representatives,
systems for collecting and managing grievances); (ii) build patient awareness of their rights and the
mechanisms through which they can provide feedback/complaint on any issues; and (iii) build capacity of
service providers to understand their roles and responsibilities with respect to patient rights.
Sub-component 1.1: Support Hospital Financing Reforms. New financing model for hospitals based on DRG
will roll out in 14 pilot hospitals in January, 2018. Three initial quality indicators for hospital treatment are
being defined and alongside two key performance indicators will serve as a basis for hospital financing. This
activity received strong support from the MoF, which will contribute sufficient funds in the 2018 Budget
towards incentive payment. Roll-out of the DRG-based payment to all hospitals in Serbia (total of 71) is
planned for 2019. Specific activities envisaged under the AF would include: i) Integration of clinical pathways
developed under the project into hospital information systems; ii) Further definition of admission criteria
based on the European version of Appropriateness evaluation protocol and adaptation to national level; iii)
Introduction of initial hospital matrix for performance monitoring and incentive for hospital physicians and
clinical teams, and iv) Improvement of regulatory framework to recognize and define performance,
expenditures and to account DRG into budgeting.
Sub-component 1.2: Strengthen Primary Health Care Financing. Financing model for PHC has improved by the
introduction of quality indicators in the formula. The new payment system where portion of the salaries of
PHC teams will be directly linked to performance-based on 10 quality indicators will be introduced in 2020.
The MoH and the Health Unions have come to an agreement that all further salary increases in the health
sector would account towards the variable or performance-based portion of the salary. This would apply to
the planned 10 percent salary increase in January 2018. Further monitoring, evaluation and upgrade of the
financing formula is of utmost importance for the success of this reform and needs to go together with
addressing regulatory framework to recognize and allow for such changes. This will also require
strengthening of managerial skills of heads of PHC facilities.

New proposed sub-component 1.3: Develop a Health Care Network Optimization Plan (Masterplan). Within
the umbrella of the National Health Care Development Plan 2020-2025, the proposed AF will support the
development of a health care network master plan. Due to fragmentation and documented under-utilization
of capacities, there is a dire need for Network Optimization Plan (Masterplan) for public health institutions
which would, at minimum, define:
• optimal capacity for the network of health institutions to correspond to the needs of population;
• functional and organizational integration of primary care centers and regional hospitals into adequate
health centers;
• rationalization of hospital and PHC capacities, including human resources strategy, with appropriately
redefining services and capacities based on needs;
• volume and scope of services, which would provide efficiency, quality and safety of care; and
• the provision of appropriate regulatory framework to allow for such restructuring.
Activities under this sub-component may also include supporting the development of palliative care,
outpatient care at hospitals (i.e. small surgery under local anesthesia, chemotherapy, internist care, etc.), and
any other interventions towards a more efficient utilization of existing capacities. Advocacy activities will also
be supported under the AF. This component would finance technical assistance and training.
Subcomponents 1.1. and 1.2. will be affected by the overall reform of public sector salaries system that will
come into force in full by January 1, 2020. The new system of public sector salaries will come into force on
January 1, 2019 with provisions related to performance based portion of salary becoming effective on January
1, 2020. This means that the full implementation of DRG and PHC related salary incentive scheme would be
possible after January 1, 2020. The Law on public sector employees envisages that all public-sector employees
(including in public health care) will be remapped to a new salary matrix during 2018. During 2019, criteria for
performance based part of the salary will have to be developed in order to be able to implement the new
system in full on January 1, 2020. Specific legal and regulatory actions are under discussions with the MoH,
MoF and the Ministry of Public Administration and Local Self Government. Scale-up activities will be defined
once actions are agreed between the Bank and Government.
COMPONENT 2: Name of the component is changed from Efficient Purchasing of Pharmaceuticals and
Medical Products to Improve Access to Quality Health Care (Euro 1.5 million)
Sub-component 2.1: Establish a Centralized Procurement System. This sub-component would be renamed to
“Improve access to medicines”. Original activities regarding the establishment of a centralized procurement
system for pharmaceuticals are expected to be completed as planned by the end of the original Loan
(September 30, 2019) and will therefore not require further support from the AF. However, under the AF,
this sub-component would support the establishment of e-health, and the continuation of activities on the
rationale use of antibiotics in line with the National Program for the Control of Antibiotic-Resistant Bacteria
and its Action Plan.
Sub-component 2.2: Strengthening Health Technology Assessment Capacity. Pharmaceutical policies

interventions focusing on building the capacity of the HIF Pharmaceutical Department – training for the
implementation of pharmacoeconomic analysis and health technology assessment (HTA) is already provided
under the original project. Due to the complexity of institutionalizing HTA to transit from ad hoc analysis to a
formal process under which decision-making is based on the HTA, it is critical that technical assistance and
overall support continue in the following areas:
• Identify and train key actors
• Perform HTA and EBM Situation Analysis
• Build an international HTA experience, acquire knowledge and develop expertise for local HTA
implementation
• Define HTA institutionalization and institutional arrangements
• Establish an appropriate HTA process and identify priority areas
• Translate research results into recommendations for decision making
• Build and gain experience in strategic planning
Sub-component 2.3: Improve Medical Equipment Maintenance Systems. One of the main SSHP goals is to
develop a strategic approach to maintenance of medical equipment aimed at developing a cost-effective
system, which represents one of the priorities for the delivery of good quality health services in Serbia. The
total replacement value of the equipment installed in Serbian health care facilities is estimated at about
US$800–900 million. An internationally accepted figure for the annual cost of a good maintenance program is
6–8 percent of the equipment capital value, which would correspond to an expenditure of US$56–63 million
per year – much higher than the budget currently allocated for maintenance. This explains, in part, the large
number of unrepaired devices in hospitals. Hospitals also encounter difficulties procuring spare parts for high-
tech equipment, contributing to equipment “downtimes” of several months. Despite fiscal constraints, the
problem cannot be ignored, as it reduces patient access to lifesaving technology and contributes to a
progressive depletion of the medical technology assets in the national health care system.
While preliminary assessment of the current distribution of medical equipment, procedures for maintenance
and repairs management, costs and allocation of funds for maintenance, and procurement of spare parts and
services will be completed under the ongoing SSHP, the proposed AF would support the MoH:
• in establishing an entity for medical technology management, including definition of its role and
staffing;
• in the selection, through International Competitive Bidding (ICB) mechanisms, of an Independent
Service Organization, to provide highly qualified multi-vendor maintenance services in one or more pilot
hospitals;
• Based on this pilot, the AF would provide technical support to MoH should it consider a possible
extension of the service to other health care facilities – either through an expanded private contract, or
through the creation of a public/private company for medical technology management, which could be jointly
owned by the Government and an Independent Service Organization. This component would finance goods,
technical assistance, training.
COMPONENT 3: Strengthen Quality of Service Delivery (Euro 19.0 million)
Sub-component 3.1: Strengthen Quality Improvement Systems. Clinical Pathways. It is expected that the 32
clinical pathways, currently being piloted in selected health care institutions, will be officially adopted and
implemented during SSHP. An additional 16 clinical pathways for PHC centers will also be developed and
implemented. The proposed AF will support the need to integrate primary and secondary health care clinical
pathways (for cancer and cardiovascular diseases at a minimum) to improve management of chronic diseases,
which represent the major burden on health. It will also help improve health care quality and enable better
management of waiting times for patients with malignant diseases. The AF will also support the update of
existing clinical practice guidelines and develop new ones. Given the complexity of using integrated pathways,
health care managers and professionals will also receive extensive training.
National Registry needs to be developed for top chronic non-communicable diseases (NCDs) in parallel with
corresponding databases which would allow for monitoring and evaluation of outcomes. The next step, to be
financed under the AF, would be the development of Disease Management Program for the most frequent
NCDs.
The Serbian Health Care Development Plan that ended in 2015 is an expert and a policy document serving as
basis for providing direction for the development of the health care system in line with the overall social
development. This document outlines the principal objectives and directions of health care development in
Serbia and is based on the health care’s general social importance and the need for representatives of the
society to take position regarding health care objectives and policies. The plan is an instrument for the further
development of the health care system policies and changes which will take place in the future (until 2025).
The Health Care Development Plan is also an important prerequisite for the adoption of national programs
and strategies in different areas of health care. The proposed AF will support the evaluation of the outcome
of the 2015 Health Care Development Plan, which will be followed by the development of an Action Plan. The
outcome of this evaluation should underpin the development of the new Health Care Development Plan
2020-2025. This sub-component would finance technical assistance, training, and operating costs.
Sub-component 3.2: Improve Cancer Management. Proposed activities under the AF are as follows:
4. The Serbian Comprehensive Cancer Management Strategy covers prevention, diagnostics and
treatment. Although efforts have been made in the past by the MoH, with support from the World Bank and
European Commission, to address screening and early detection of leading malignant diseases (cervical, colon
and breast cancer), no significant progress has been achieved to date. Diagnosed cancer cases are
predominantly stages III or IV. Comprehensive approach to cancer control is needed to improve and align
cancer prevention and enhance efficiency so as to (a) establish and strengthen early disease detection
system; (b) promote use of digital technologies in cancer registration and patient treatment data collection,
transfer, treatment decisions, and analytics against an internationally recognized format; (c) institutionalize
more vigorous health promotion activities; and (d) put in place appropriate infrastructure and advanced
treatment modalities for tertiary level cancer treatment, which hampers the effectiveness and efficiency in
the use of human and financial resources.
5. Improvement of National Coverage of Radiotherapy Services. Six linear accelerators (LINAC), varying
in technical specifications and requirements, and three CT-simulators have been procured for the four
oncology institutions in Serbia (Belgrade, Kragujevac, Nis and Kladovo) under the parent project and full
installation should be completed by March 2018. In parallel, the Government of Serbia has purchased four
LINACs from the budget aiming to achieve international standards for radiotherapy coverage.
About 11,000 people in the northern province of Vojvodina (VOI) are affected by cancer annually, 4,000 of
whom need radiation or combined chemotherapy and radiotherapy. On a monthly level, more than 200
patients for whom the oncological committee has indicated radiation therapy are registered in the list of
appointments. In September 2017, the waiting list for radiation therapy at the VOI included 368 patients.
Approximately 60 percent of patients from the waiting list are breast cancer patients followed by
gynecological and colorectal cancers. To date, VOI has not benefitted from the radiotherapy procurement. It

is proposed that retroactive financing be considered for the procurement of the equipment for VOI under the
proposed AF.
To achieve full territorial radiotherapy coverage and provide equity, access and standardized quality of cancer
treatment across the country, the proposed AF would finance two new LINACS and rehabilitation of the two
bunkers for VOI. The VOI’s Radiotherapy Clinic has qualified staff and is fully equipped for new accelerators.
Due to Government’s prerogative to secure equity in access and quality of cancer treatment throughout the
country, this activity would be subject to retroactive financing.
Climate Change and Disaster. Given that this sub-component will support the rehabilitation of two bunkers
for the LINACs, climate change and geophysical hazards (such as flood as in 2014) could impact the structural
integrity, materials, siting, longevity and overall effectiveness of the investments. However, this is considered
as low risk as climate and geophysical hazards, such as flood, are not likely to impact overall project activities.
Nevertheless, the planned works for the two bunkers will incorporate climate and natural disasters resilience
considerations (e.g., resilience to floods, extreme temperature increases, etc.).
6. Improvement of Timely Diagnostics in Oncology. While the original project has supported Serbia in
meeting international standards in treatment, the needs for diagnostics equipment have been put aside, as
the MoH’s focus was on providing conditions for timely treatment and addressing waiting lists for cancer
treatment. Now that international standards in radiotherapy in Serbia will be met during the length of the
project (SSHP and AF), conditions will be in place for addressing issues of under-diagnostics and late
diagnostics. It is of utmost importance to increase the quality of diagnostics for timely and efficient cancer
management.
In 52.2 percent of the cases, the disease is diagnosed in an advanced stage, with regional and distant
metastases present. Such late diagnostics not only adversely affects treatment outcome, but increases the
health care system expenses as well due to requirement of applying more and costlier treatment options.
The latest data from the Institute of Public Health show that Serbia is among the countries with the lowest
number of CT scanners and MRIs. Improved and early diagnostics in oncology is important not only because
diagnosing and treating cancer at an early stage can save lives, but also because of its budgetary implications.
Fiscal impacts of such health care policy are also significant, having in mind that savings could be achieved
through reduced funds for high-cost oncology drugs. Such approach increases the quality of care and
efficiency in public spending on health. Providing opportunities for timely cancer treatment and clearing
waiting lists, thanks to the provision of LINACs, will create space for early, improved diagnostics which calls
for additional modern equipment (mainly MRI and scanners). The proposed AF could support the MoH in
addressing this issue provided that the MoH fulfill the following conditions of disbursements, all satisfactory
to the Bank: (i) adoption of a comprehensive National Cancer Strategy; (ii) adoption of a Network
Optimization Plan; and (iii) institutionalization of a sustainable Medical Equipment Maintenance System.
The proposed AF would finance procurement of CT scanners and MRIs, but the precise number and
distribution of new diagnostic equipment will be subject to a comprehensive needs analysis. Procurement of
diagnostic equipment as well as the PET Center would be conditioned (conditions of disbursement) by the
implementation of a National Cancer Management Strategy, a Health Care Network Optimization Plan, and
the institutionalization of a medical equipment maintenance system for defined new high cost equipment.
This sub-component would finance works, goods, technical assistance, and training.
COMPONENT 4: Monitoring, Evaluation and Project Management (1.5 million Euro)
The proposed AF will cover the additional three-year extension period of day-to-day management,
monitoring and evaluation, audits of the project. This component will also support activities (linked to all
components) directed to the Roma population. It will finance operating costs, studies, and training.

ANNEX 5: Report on Public Consultation
SECOND SERBIA HEALTH PROJECT (SSHP)
REPORT ON PUBLIC CONSULTATIONS
for
ENVIRONMENTAL MANAGEMENT
FRAMEWORK DOCUMENT
„Second Serbia Health Project – Additional Financing“, subcomponent 3.2:
PURCHASE AND INSTALLATION
OF LINEAR ACCELERATORS, CT SIMULATORS, CT SCANNERS, PET/CT

SCANNERS, MRIs, CYCLOTRON FACILITY
- Environmental Category B -

Belgrade, January 2018

1. BACKGROUND
The Government of Serbia has requested a support from the World Bank for additional financing and
consequently extension of the activities within Second Serbia Health Project. The request refers to additional
financing from the IBRD loan in the amount of 25 million EUR (equivalent to US $ 29.3 million) to the Republic
of Serbia for the Second Health Development Project of Serbia (P129539) . The original loan of 29.1 million
euros (equivalent to $ 40 million) was approved by the Board of Executive Directors on February 25, 2014,
and came into force on May 8, 2015, and the closing date is September 30, 2019. The proposed additional
funding (AF) would finance the realization of expanded activities that are in line with the activities of the
parent project. These activities would support a comprehensive reform program in the health care system to
improve efficiency, improve quality, ensure greater transparency, and rationalize oversized healthcare
institutions with an integrated approach to address cancer management and cover radiotherapy services.
Providing modern diagnostics within the project will be fully in line with the expanded reform program,
including the optimization of the health network and the development of a long-term comprehensive
national cancer strategy.
Subject of this EMFD will be provided as a part of additional financing of Component 3: Support Quality
improvement in Service Delivery including for Management of Cancer Treatment.
This component aims to improve standards of quality and efficiency of care in the Serbian health sector
through two main approaches: (i) strengthening quality improvement systems; and (ii) modernizing cancer
management at selected tertiary facilities.
Sub-component 3.2: Improve Cancer Management
The proposed AF would finance two new LINACS and rehabilitation of the two bunkers for Vojvodina
Oncology Institute (VOI). The VOI’s Radiotherapy Clinic has qualified staff and is fully equipped for new
accelerators. While the original project has supported Serbia in meeting international standards in treatment,
the needs for diagnostics equipment have been put aside, as the MoHs focus was on providing conditions for
timely treatment and addressing waiting lists for cancer treatment. The proposed AF would finance
procurement of CT scanners and MRIs, but the precise number and distribution of new diagnostic equipment
will be subject to a comprehensive needs analysis. Procurement of diagnostic equipment as well as the PET
Center would be conditioned (conditions of disbursement) by the implementation of a National Cancer
Management Strategy, a Health Care Network Optimization Plan, and the institutionalization of a medical
equipment maintenance system for defined new high cost equipment.
The Project has been classified as Environmental Category B. i.e. a project requiring an EMP pursuant to IFIs
Safeguard Policies. According to the current Serbian legislation, particularly following Serbian Law on EIA
(Official Gazette of RS, No 135/04, 36/09) – EIA is not required for this kind of medical equipment.
SSHP Project Team prepared draft EMF document for the purchase and installation of linear accelerators, CT
simulators, CT scanners, PET/CT Scanners, MRIs and Cyclotron, which was submitted to WB for comments
and remarks during January 2018. EMFD has been prepared in order to ensure application of the good
environmental practice and project compliance with the requirements of the World Bank which will ensure
Second Serbia Health Project - Additional financing.

In parallel with public consultation, on January 30, 2018 WB comments on EMF document were delivered to
the SSHP Environmental Specialist.
As regards to public consultation, on January 25, 2018 SSHP announced invitation for Public Consultations for
the public, bodies and organizations interested in EMFD for purchase and installation of linear accelerators,
CT simulators, CT scanners, PET/CT Scanners, MRIs and Cyclotron. Public and other interested parties and
organizations were invited to participate in process of public consultation on draft EMF document. Parallel
with the announcement in the newspapers, the EMFD was published on Ministry of Health’s web site, and
informed the public of the time and place of public consultations. Insight into the EMP document was
ensured on following addresses:
- the premises of the SSHP Coordination Unit, DZ „Savski venac“, Pasterova St. 1,
Belgrade, on working days from 09:00 AM to 15:00 PM (local time), within 3 days
starting from January 25, 2018.
- on MoH web site: www.zdravlje.gov.rs
Public Consultation and presentation of EMP document were held in the premises of the SSHP Coordination
Unit, DZ „Savski Venac“, on January 30, 2018, from 10:00 AM to 11:30 AM.
2. REPORT ON PUBLIC CONSULTATION, BELGRADE, JANUARY 30TH, 2018
In accordance with OP/BP 4.01, MoH/SSHP has prepared EMF document for purchase and installation of
linear accelerators, CT simulators, CT scanners, PET/CT Scanners, MRIs and Cyclotron.
The in-country disclosure of the EMF document started on January 25, 2018 when invitation to the interested
parties were published in the daily newspaper “Politika”, inviting the public, authorities and relevant
institutions to have an insight into the proposed document on purchase and installation of of linear
accelerators, CT simulators, CT scanners, PET/CT Scanners, MRIs and Cyclotron and environmental impact of
the project, with presented mitigation and monitoring measures. Parallel with the announcement in the
newspapers, document was placed at MoH web site.
Disclosure of draft EMP document finished on January 30, 2018 when the public meeting was held in
premises of SSHP Coordination Unit.
There were three (3) attendees on public consultation meeting: Mr Vojisalav Antic, Mr Igor Komar and Mr
Miro Urosevic.
On behalf of SSHP the meeting was attended by Mrs Biljana Kozlovic – SSHP Project Coordinator, Mr Nikola
Kerleta, SSHP Specialist for procurement, Mrs Zana Cvetkovic, - SSHP Assistant for procurement and Mrs
Milica Duronjic, SSHP Specialist for environmental protection. Also, a public consultation was attended by Mrs
Zlata Bilandzija – Masinoprojekt.
The meeting started according to schedule at 10:00 AM, and ended at 11:30 AM.
The public consultation meeting started with short presentation regarding the parent project and objectives
and activities planned to be implemented under the AF, provided by Mrs Biljana Kozlovic, and short
presentation regarding the draft EMF, including its purpose, objectives, content and scope. After
presentations, attendees were invited to comment and discuss the draft EMF Document.

There were no comments regarding the draft EMF Document for additional financing, and the participants
supported the entire health care reform project with the emphasis on the procurement of medical
equipment for the treatment and early diagnosis of cancer.
The public consultation ended at 11:30 AM.


Second Serbia Health Project: Additional Financing

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Second Serbia Health

ENVIRONMENTAL MANAGEMENT FRAMEWORK DOCUMENT Page 0

ENVIRONMENTAL MANAGEMENT FRAMEWORK DOCUMENT Page 1

ENVIRONMENTAL MANAGEMENT FRAMEWORK DOCUMENT Page 2

AZUS Agency for Accreditation of Health Care Institutions of Serbia

DRG-s Diagnostic Related Group System

e-HDF e-Health Development Framework

EIA Environmental Impact Assessment

EMFD Environmental Management Framework Document

EMP Environmental Management Plan

HIF Health Insurance Fund

HTA Health Technology Assistant

LINAC Linear Accelerator

PCF Primary Care Facilities

SSHP Second Serbia Health Project

T2DM Type 2 Diabetes Mellitus

VOI Autonomous Province of Vojvodina

WB The World Bank

WMP Waste Management Plan

MeV megaelectron volt

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1. DESCRIPTION OF PROJECT COMPONENTS INCLUDING DESCRIPTION OF TYPE

1.2 Project description

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Component 2: Efficient Purchasing of Pharmaceuticals and Medical Products (US$7.0 million)

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Component 3: Strengthening Quality of Service Delivery (US$22.4 million)

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1.2.1 Medical equipment for cancer treatment

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1.2.2 Scope of additional financing

2. Improvement of National Coverage of Radiotherapy Services. Six linear accelerators (LINAC),

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1.3 Objectives of the Environmental Management Framework Document

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1.4 Approach and Methodology

2. OPERATING REQUIREMENTS – DIAGNOSIS OF LEGAL AND

2.2 Relevant information

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2.4 Other Relevant Government Policies, Act, Rules, Strategies and

 The Constitution of Serbia (’’Official Gazette of RS’’, No. 98/06)

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2.4.1 The Constitution of Serbia

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2.4.3 Law on Medical Devices

2.4.4 Law on Ionizing Radiation and on Nuclear Safety

2.4.5 Law on Environmental Protection

The main focuses of LEP are:

To implement the Law on Environmental Impact Assessment, a government Decree determines

2.4.4 Law on Environmental Impact Assessment

 Declaration of ecologically critical areas;

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2.4.6 The Law on Occupational Safety and Health

2.4.7 The Law on Planning and Construction

2.5 World Bank’s Environmental Safeguard Policy