Mongolia: Fourth Health Sector Development Project

Sovereign Project | 41243-012 Status: Active

Summary

ADB is helping Mongolia improve hospital services in the capital, Ulaanbaatar, and strengthen the country's drug safety regime. The project will assist in preparing the first hospital development policy for Ulaanbaatar, strengthen medical residency training and postgraduate programs as part of human resource development, set up a drug regulatory authority, and upgrade a drug control laboratory.

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Procurement Documents


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Project Name Fourth Health Sector Development Project
Project Number 41243-012
Country Mongolia
Project Status Active
Project Type / Modality of Assistance Grant
Loan
Source of Funding / Amount
Grant 0236-MON: Fourth Health Sector Development Project: Improving Sector Governance
Asian Development Fund US$ 14.00 million
Grant: Fourth Health Sector Development Project
World Health Organization US$ 450,000.00
Loan 2932-MON: Fourth Health Sector Development Project - Additional Financing
Asian Development Fund US$ 25.00 million
Strategic Agendas Inclusive economic growth
Drivers of Change Governance and capacity development
Sector / Subsector

Health - Health sector development and reform

Gender Equity and Mainstreaming Effective gender mainstreaming
Description
Project Rationale and Linkage to Country/Regional Strategy
Impact

Project Outcome

Description of Outcome
Progress Toward Outcome
Implementation Progress
Description of Project Outputs
Status of Implementation Progress (Outputs, Activities, and Issues)

Component 1

Output 1.1.

A major output of the Project is the development and approval of a hospital policy for Ulaanbaatar city which will direct changes in the way Ulaanbaatar city hospitals are financed, managed, organised and deliver services. The policy was intended to cover private sector participation, governance and autonomy issues and future public sector investment. MOH working group with the support from Project consultants developed a draft policy, which was discussed and commented in 2012 by a high level strategic planning committee.

In June 2012, the MOH decided to extend the document to cover hospitals nationwide and the policy document underwent extensive discussion and review at the ministry level throughout 2013. A shorter version of a "Hospital Care Development Policy" document was approved through a ministerial order in February 2014. A draft Implementation Strategy Plan to facilitate and guide the proposed reforms is scheduled to be discussed and finalized in December 2014. Output 1.2.

In March 2012 a review of the current capital planning system was carried out by an international consultant. An assessment of public infrastructure and equipment in Ulaanbaatar was carried out covering 37 hospitals of various types. The assessment intended to provide a basis for estimation of infrastructure investment needs and contribute to a strategic development plan to reform the hospital sector in Ulaanbaatar. Capital planning procedures developed by international consultant and the assessment of the infrastructure investments needs of the Government are available. As a next step, by the end of 2015, the MOH will define the future capital planning system which would address institutional, human resources, information technology, financial requirements and investments to restructure and develop the hospital sector, as well as the types of processes needed.

Output 1.3.

The development of a model multifunctional general hospital in Songinokhairkhan district is intended to assist in the ongoing health and hospital sector reform by instituting best management practices, organisational processes, and restructured clinical services. The original plan was to renovate the existing hospital and have a restructured facility operational by June 2015. The new hospital would include modern systems of human resources, governance, waste management, IT and clinical services delivery. In 2012 the government requested additional funding of $25 million as a concessional loan for a new hospital, instead of renovating and appending new wings to the existing structure. The FHSDP-AF, the Loan, became effective on 14 June 2013.

The Project has engaged SIMED (Netherland), an international hospital planning and design consulting firm, to develop the concept design and functional requirements. To date, SIMED has produced a Concept Design and Functional Plan for the new hospital. The detail design is prepared by Junglim Architect (Korea) which is approved by the state expertise. The construction works to start in 2016. The MOH finalized the Songinokhairkhan hospital development plan in March 2016.

Output 1.4.

Licensing issues were addressed largely as a result of the Third Health Sector Development Project (THSDP) through ministerial orders (no. 143, 145) in April 2013 on regulating public and private health organizations. These orders included recommendations on certificates of need, licensing and regulatory frameworks for both public and private hospitals and clinics and other healthcare facilities.

Component 2

Output 2.1.

International consultants reviewed the postgraduate training system and proposed a draft institutional framework to address system limitations. At a consensus meeting, the ministry of education, the ministry of health, hospitals and teaching universities agreed on the recommendations to extend the period of specialty training; to remunerate residents undergoing specialist training; to adopt the revised curricula; and to define the legal basis for medical education in the Health Law. But the issue of the institutional base for organising postgraduate education has still not been agreed. Consultants proposed in-service hospital based training as the most preferred approach for improved specialty training. However, this issue could be resolved only by improving respective laws and regulations.

Project consultants reviewed residency training program and curricula in four clinical areas (internal medicine, general surgery, obstetrics-gynaecology and paediatrics); recommendations for improvement were discussed and agreed by working groups comprised of specialists in these clinical areas. The postgraduate training for nurses was also reviewed by consultants, and training curricula for nursing streams were reduced from 26 to 9 with a strong emphasis on in-service training in the hospital. The trainer's curriculum was developed to improve leadership skills in senior nurse managers (nurse director, chief nurse and ward manager).

Output 2.2.

Project consultants assessed hospital management training in Mongolia. Among the limited number of institutions which provide management training with various degrees of quality, the program offered by the School of Public Health of the Mongolian National Medical Science University was preferred for institutionalization as the hospital management training. The School of Public Health in association with the Association of Public Health Specialists and Management Academia developed a training curriculum, which was approved by MOH. The hospital managers training was organized in September 2013, and the training of the first batch of 25 managers (with 20 female participants 80%) was undertaken between October 2013 and January 2014. As a next step, 25 additional managers will undergo the training in 2015. The hospital managers' training curricula consists of 6 modules and is based on an enquiry-based learning approach. The participants are expected to have hands-on experience in hospital management.

Component 3

Output 3.1. and 3.2.

The Project's aim is establish a drug regulatory authority and strengthening regulatory functions to improve coordination and quality. An amended drug law passed in 2010 includes provision for the establishment of a Drug Regulatory Agency (DRA) with 10 regulatory functions under MOH. The core of a new DRA with 18 staff was established in 2011 in the Drug Regulatory Division of the Department of Health (DOH/DRD). It was abolished in September 2012. Currently only 8 of the regulatory staff have been retained in the MOH Pharmaceuticals and Medical Devices Division (PMDD).

OPM provided technical assistance to initiate the DRA including a draft strategic plan, concept note, organizational structure and financing arrangements, and assistance with a draft medicines bill.

In strengthening regulatory functions, the OPM consultants have trained and mentored the original DOH/DRD staff and the interim regulatory staff in PMDD; several technical guidelines have been revised and approved (Good Manufacturing Practice, Good Distribution Practice and Good Pharmacy Practice). A baseline review of drug regulatory functions was undertaken using the WHO methodology in late 2011 and results were presented to relevant stakeholders. Mongolia's score of 46.9% in drug regulation show the need to strengthen drug regulatory functions. A team of local experts under WHO international experts' guidance conducted a nationwide survey on the prevalence of unsafe drugs in the market in 2012. The survey revealed that 29% of medicines circulating in Mongolia are illegal (unregistered) or substandard. Project consultants developed and revisited drug regulatory procedures and some of them (registration procedures, adverse drug reaction reporting) were approved by MOH. A new National Medicines Policy, developed with technical support of OPM, endorsed by the Cabinet and ratified by the Parliament in October 2014, was the foremost achievement of this component. The National Medicines Policy covers core areas in medicine regulation such as medicines quality and safety, rational use, access, provision, distribution, and governance. The Project aim of establishing a website on the DRA and drug governance, along with an E-library was postponed until a DRA is established. The Project is assisting MOH in upgrading the drug regulatory database LICEMED that would lead to improved quality data base of registered products, licensed providers, and specialists available online.

Output 3.3.

Upgrading and strengthening of the Drug Control Laboratory (DCL) of the GASI is an important element for drug safety, and steady progress has been made in this field. The DCL moved to the new building built with the support of the Government of PRC in January 2013; new equipment provided by the Project was installed in November 2013 with on the job training from supplier companies. OPM consultants developed a Strategic Plan and ISO-17025 Accreditation Action Plan which were approved by DCL. Project consultants developed a laboratory quality management system including quality manual, standard operational procedures, record and reporting forms for the DCL. The DCL is awarded the ISO-17025 certificate in December 2015.

Output 3.4.

The Project aimed to upgrade standards, inspectorate, regulations and manufacturer capabilities with a target of at least five local drug manufacturers certified at international GMP standards by 2015. Project consultants conducted a gap analysis against the WHO GMP Guidelines and developed a new national GMP standard (MNS 5524:2014) which was approved by the Mongolian Agency for Standardization and Metrology. A GMP certification procedure was developed and approved by MOH. GASI inspectors were involved in GMP assessments by the international GMP consultant, and invited to all GMP trainings. According to the OPM consultants, GASI inspection procedures are not compatible with WHO Good Inspection guidelines and the methods of GASI's GMP inspection are problematic. The MOH will engaged GMP qualification experts from WHO in 2015 to get professional opinion in regard to the existing quality management system for GMP inspection (under GASI).

OPM consultants assisted in developing manufacturer capabilities to upgrade facilities and train personnel. Training on GMP principles and good practices was done in 2012-2014 with participants from local drug manufacturers (production and quality control managers), medicines control laboratory and pharmaceutical associations. Consultants have also conducted a regular assessment in the 7 most promising local drug manufacturers since 2011 to support them to be certified by the upgraded GMP standard.

Output 3.5.

The aim is to establish a basis for monitoring and reporting on adverse drug reactions to increase awareness of the problem and to institute preventive and corrective measures in hospitals. MOH with support of project consultants developed and approved in 2013 a National Pharmacovigilance strategy and a ministerial order on Procedure on adverse drug reaction reporting and periodic safety update report of medicine . Trainings for medical professionals and members of hospital drug committees were conducted in 2013-2014. The number of reported ADRs has increased 4-times since the ADR training and publication of the ADR reporting manual. Twenty ADR case reports were filed in Vigibase (the global ADR database in Uppsala, Sweden) enabling Mongolia to attain full membership in the WHO International Drug Monitoring Programme.

Output 3.6.

The objective of this output was to achieve strengthened drug safety governance functions at MOH with a pharmaceutical management information system. In 2010, WHO conducted a Country case study on Good Governance in the Pharmaceutical Sector in Mongolia. The results showed a moderate vulnerability to corruption with 6.169 and 6.208 ratings , meaning that registration, promotion, inspection, selection and procurement of medicines in Mongolia are conducted according with specific rules and legal acts. But violations are not properly punished even though the legal acts provide necessary provisions; there is no system for enabling the public to have equal and accessible information; and availability and accessibility of the instructions for the members of the drug registration, selection and tendering committees are insufficient. Project has initiated a review of a good governance of the pharmaceutical sector using WHO Good Governance Medicines Framework process in 2012. The MOH built the principles of a Good governance functions into the National Medicines Policy, approved by Parliament in October 2014. Project consultants assessed the current strategy to fight against illegal, counterfeit and/or substandard drugs and introduced recommendations to MOH, along with results of the national counterfeit drug survey undertaken in 2012. The MOH approved the anti-counterfeiting strategy in 2012.

Geographical Location

Safeguard Categories

Environment B
Involuntary Resettlement C
Indigenous Peoples C

Summary of Environmental and Social Aspects

Environmental Aspects

An environmental assessment has been carried out in accordance with the Mongolia regulatory framework and ADB's Safeguard Policy Statement (2009). A consolidated initial environmental examination (IEE) report was prepared, which assesses and addresses the environmental implications of the rehabilitation and expansion of the Songinohairkhan District Hospital and the New Central Laboratory. The team and project counterparts agreed to specify the whole laboratory building as an associated facility. This allowed conducting necessary due diligence for the building, resulting in the conduct of the necessary domestic environmental assessment, ensuring compliance with the Mongolian law. The consolidated IEE summarizes the findings of the New Central Laboratory Environmental Impact Assessment (EIA) and the Songinohairkhan District Hospital Initial Environmental Examination (IEE), and a due diligence review of project associated facilities. Potential adverse impacts during the construction and operation phase include limited standard construction impacts; and occupational and community health and safety issues, especially the unsafe collection, storage, treatment, and disposal of medical and chemical hazardous waste. The possible adverse environmental impacts will be prevented or minimized to acceptable levels, through the implementation of the environmental management plan (EMP) that includes adequate mitigation and monitoring arrangements. Following up the Inception mission, project national environmental consultant had reviewed the Environmental Management Plan (EMP) of the project and updated relevant sections based on mission recommendations and results of situation analysis and submitted to ADB in June.

The environmental assessment process achieved significant value added by (i) catalyzing, through policy dialog with MNET and GASI, the development of an EIA for the project's associated new central laboratory building; (ii) developing comprehensive management systems for the collection, storage, and treatment of medical and hazardous chemical waste; and (iii) developing a substantial consolidated IEE report which defines environmental mitigation measures, monitoring requirements, institutional responsibilities, and training and capacity building requirements.

The Inception mission reviewed the progress of project preparation with regard to environmental safeguards, and agreements were reached on the next steps and responsibilities. Field visits were conducted to the Songinokhairkhan district hospital, the new Central Laboratory, and the medical waste treatment facility operated by Element Company.

The Grievance Redress Mechanism (GRM) guidelines were developed in accordance with recommendations and templates provided by the ADB environmental specialist and submitted to ADB on 9 June and received feedbacks and incorporated them into the guidelines. GRM section of EMP was also revised.

Involuntary Resettlement No involuntary resettlement effects are foreseen and the project is classified as a category C project. The upgrading of the facilities of the multifunctional hospital will be on existing government land and will not affect local residents or residential buildings. A resettlement plan and framework are therefore not required. Should there be any change in scope or other changes with unanticipated resettlement impacts during project implementation, land acquisition and resettlement activities will be implemented in accordance with ADB's Safeguard Policy Statement.
Indigenous Peoples The project will not have any negative impact on indigenous peoples and is therefore classified as a category C project. No further actions are therefore required.
Stakeholder Communication, Participation, and Consultation
During Project Design Consultations with key stakeholders were held during project preparation including focus groups with beneficiaries such as local community member and hospital patients, in-depth interviews with family general practice doctors, hospital directors, and specialist doctors in Ulaanbaatar. The first series of consultations investigated current access to health services and medical drugs by the poor, and the findings are included in the poverty and social analysis section above. The second round of interviews and focus groups were held with hospital doctors and inpatients to solicit their views, suggestions, and recommendations regarding the proposed project design to establish a multifunctional hospital and a drug regulatory body. The multifunctional hospital will involve establishing new patterns of service delivery which will be complex and there may be risks associated with it. For this reason effective ways of defining and measuring the quality of hospital care will be established and systems will be put place to redress poor quality service should it arise.
During Project Implementation

The project has contracted two local NGOs ( Monconsult LLC and Shagdui ) to implement the consultation and participation activities of the project and to foster participation and community involvement. A Patient Satisfaction Survey is a major part of the C&P plan which aimed to evaluate and assess the impact of project activities related to hospital reform. Monconsult developed the design and survey methodology (approved by the ethical committee of the National Center for Public Health in 2014). The baseline survey was conducted in 2014 involving 311 patients of the Songinokhairkhan hospital. Patients were asked how they see the hospital environment, quality of service they received, attitude of medical staff toward them, whether informal payments were made, and what problems they encountered. In addition to quantitative data collection through questionnaire, patients were invited for face-to-face discussions to obtain qualitative information on their views about skills and capacity of medical staff, factors influencing quality of care and solutions they propose in order to improve hospital services.

12. A community awareness program is being implemented by Monconsult in Songinokhairkhan district with the aim of raising awareness among community of the district hospital catchment area of ongoing hospital reform and drug safety so that they can participate in monitoring developments and provide their feedback. Monconsult developed information education and communication (IEC) program on (i) hospital reform and (ii) drug safety. Implementation of IEC activities will start in 2016. Monconsult is using Community Score Cards (CSC) to collect data from community and monitor changes using the scores. The first score cards were collected from 108 residents and patients in April 2015; assessment and discussions on findings of the score cards took place in June 2015. It was proposed to collect score cards on a yearly basis. The CSC is a relatively new tool that is used for the first time in the health sector to monitor public opinion in regard to provision of public health services. Therefore it is important to have experts' views with regard to design, methodology and implementation arrangements of the CSC.

13. Information and outreach program is another part of the project C&P plan. Shagdui developed a draft communication strategy to effectively communicate the content of the Hospital Care Development Policy (2014) and the National Medicines Policy (2014) to community members and project stakeholders. The draft communication strategy is supported by an implementation plan for 2016-2018. The Mission notes that the implementation plan is missing cost estimates, which are necessary for planning further project activities. The communication strategy is yet to be approved by MOHS before end of 2015; implementation of information and outreach activities will start from 1Q 2016.

Business Opportunities

Consulting Services The Recipient is responsible for selecting, engaging, and supervising Consultants engaged under the loans and grants funded by ADB. All consultants will be recruited according to ADB's Guidelines on the Use of Consultants (April 2010, as amended from time to time).
Procurement All procurement of goods and works will be undertaken in accordance with the Asian Development Bank's (ADB) Procurement Guidelines (2010, as amended from time to time). International competitive bidding (ICB) will be applied to goods contracts estimated to cost $2,000,000 or more and works contracts estimated to cost $5,000,000 or more. Goods contracts with values less than $2,000,000 and works contracts with values less than $5,000,000 will follow national competitive bidding (NCB). Works and goods contracts with values less than $100,000 will be procured using ADB's shopping procedure. NCB procurement will be carried out on the basis of NCB procedures, in accordance with the Mongolian Procurement Law, subject to modifications agreed with ADB. Before the start of any procurement, ADB and the government will review the public procurement laws of the central and state governments to ensure consistency with ADB's Procurement Guidelines. The internationally tendered equipment packages will include the necessary technical support for ensuring proper installation, testing, commissioning, and training of operational staff as part of the related contracts. In accordance with ADB requirements, foreign contractors may participate in bidding for NCB contracts. For NCB, the first draft English language of the procurement documents (prequalification, bidding documents, draft contract) should be submitted for ADB approval regardless of the estimated contract amount. Subsequent procurement are subject to post review. All ICB contracts are subject to prior review. Prior review and approval of ADB of the procurement documents (prequalification, bidding, contract) is required.

Responsible Staff

Responsible ADB Officer Altantuya Jigjidsuren
Responsible ADB Department East Asia Department
Responsible ADB Division Mongolia Resident Mission
Executing Agencies
Ministry of Health and Sports
HSDP@MAGICNET.MN
1st Floor, Government Building VIII
Olympic Street 2, Ulaanbaatar
Mongolia

Timetable

Concept Clearance 04 Jun 2010
Fact Finding 18 May 2010 to 20 May 2010
MRM 03 Sep 2010
Approval -
Last Review Mission -
PDS Creation Date 19 Oct 2010
Last PDS Update 31 Mar 2016

Grant 0236-MON

Milestones
Approval Signing Date Effectivity Date Closing
Original Revised Actual
29 Nov 2010 10 Dec 2010 03 Mar 2011 31 Dec 2016 31 Dec 2018 -
Financing Plan Grant Utilization
Total (Amount in US$ million) Date ADB Others Net Percentage
Project Cost 17.70 Cumulative Contract Awards
ADB 14.00 29 Nov 2010 4.22 0.00 30%
Counterpart 3.70 Cumulative Disbursements
Cofinancing 0.00 29 Nov 2010 4.19 0.00 30%
Status of Covenants
Category Sector Safeguards Social Financial Economic Others
Rating Satisfactory - - Satisfactory - Satisfactory

Loan 2932-MON

Milestones
Approval Signing Date Effectivity Date Closing
Original Revised Actual
05 Nov 2012 07 Feb 2013 14 Jun 2013 31 Dec 2016 31 Dec 2018 -
Financing Plan Loan Utilization
Total (Amount in US$ million) Date ADB Others Net Percentage
Project Cost 27.00 Cumulative Contract Awards
ADB 25.00 05 Nov 2012 0.99 0.00 4%
Counterpart 2.00 Cumulative Disbursements
Cofinancing 0.00 05 Nov 2012 1.01 0.00 4%
Status of Covenants
Category Sector Safeguards Social Financial Economic Others
Rating Satisfactory - - Satisfactory - Satisfactory

Safeguard Documents See also: Safeguards

Safeguard documents provided at the time of project/facility approval may also be found in the list of linked documents provided with the Report and Recommendation of the President.

Evaluation Documents See also: Independent Evaluation

None currently available.

Related Publications

None currently available.


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