Final Report - Clinton Health Access Initiative.pdf

Final Report

Comprehensive Assessment of PMED’s Organizational Capacity and its Role in the Pharmaceutical and Medical Devices Sector

November 2020 Addis Ababa

Ethiopia

Comprehensive Assessment of PMED’s Organizational Capacity and its Role in the Pharmaceutical and Medical Devices Sector

November 2020

A Report submitted By Clinton Health Access Initiative to Bill and Melinda Gates Foundation funded under Grant ID INV004723

Comprehensive Assessment of PMED’s Organizational Capacity and its Role in the Pharmaceutical and Medical Devices Sector

Comprehensive Assessment of PMED’s Organizational Capacity and its Role in the Pharmaceutical and Medical Devices Sector

Table of Contents

Acronym iv Executive Summary v

1. Introduction 1

1.1 Background to the assessment 1

2. Objectives of the assessment 1

3. Methodology 2

3.1 Assessment framework 2

3.2 Assessment design and approach 3

3.2.1 Data collection methods 3

3.2.2 Data Sources 4

3.2.3 Data analysis 5

3.3 Scope 5

3.4 Limitations 5

4. Assessment Findings 6

4.1 Overview of the Pharmaceutical and Medical Devices Management Sector 6

4.2 Major Achievements so far 6

5. Assessment Findings and Discussion 9

5.1 Historical Evolution of PMED 9

5.2 Organizational Capacity of PMED 10

5.2.1 Current Structure of PMED in MOH and communication system 10

5.2.2 Leadership and Governance 12

5.2.3 Human resources 13

5.2.4 Resource mobilization and financial management 15

5.2.5 Monitoring and evaluation 17

5.2.6 Partnerships, External Relations and Networking 19

5.2.7 External environment affecting the sector 26

6. Recommendations 29

7. References 41

8. Annex 1 – Structure and Key Roles for Health Care Commodity and Technologies 45

Annex 1A – Pharmaceutical Management Directorate 45 Annex 1B - Medical Devices Directorate 47 Annex 1C - Traditional Medicine Directorate 48 Annex 1D - Supply Chain and Support Directorate 49 Annex 1E – Regional, Zonal and Woreda level structures 50 Annex IF-Zonal level structure for pharmaceutical and biomedical 50 Annex IG: Woreda level structure for pharmaceutical and biomedical 52

Annex 2 – Details of the mandate analysis exercise 53 Annex 3 - List of MOH/PMED related software 66 Annex 4 – Core decision points in the supply system 67

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

Annex 5 – Summary of country experiences 68 Annex 6 – List of interviewed people 74

List of Tables and Figures Tables

Table 1: summary of PMED and Key Agencies Chronological Events and Interaction in efforts of strengthening Pharmaceutical and Medical Device management process 8

Table 2 - Budget allocated to PMED in ETH, 2012 EFY 15

Table 3 - Comparison of budget allocation for different Units in ETB, 2012 EFY 16

Table 4 - Share of Budget Allocated for Different Agencies/Directorates/Units, 2012 EFY 16

Table 5 - Summary of regional PMED equivalent structure 23

Table 6 - Progress in key pharmaceutical indicators in the regions, EFY 2011 25

Table 7 - Role demarcation between the key pharma/biomed sector players 31

Figures

Figure 1 – Conceptual framework of capacity factors that affect goal achievement 3

Figure 2 - Current Organogram of PMED 10

Figure 3: Revised structure for PMED 37

Figure 4: Suggested structure Health Care Commodities and Technologies Directorate General 39

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

Definitions

Health Care Commodity - means any substance or mixture of substances used in the diagnosis, treatment, mitigation/rehabilitation or prevention of disease and/or injury/trauma, that includes medical equipment, instruments and supplies;

Traditional Medicine – in this report it also incorporates complementary and alternative medicine Short term – in the report we refer to the short term as a period between the current/ immediate year and 2023.

Medium Term – refers to the period between 2024-2027 Long term - refers to the period 2028 - 2030

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

Acronym

AMR Anti-Microbial Resistance APTS Auditable Pharmaceutical Transaction and Service CSA Central Statistical Agency DHIS District Health Information System DPCD Disease Prevention and Control Directorate DTC Drug and Therapeutic Committee EFDA Ethiopian Food and Drug Authority EFY Ethiopian Fiscal Year EHIA Ethiopian Health Insurance Agency EPHI Ethiopian Public Health Institution EPSA Ethiopian Pharmaceutical Supply Agency FGD Focus Group Discussion FMHACA Food Medicine and Health Administration and Control Authority HC Health Center HCT Health Care Technology HDI/R Human Development Indicator/ Report HID Health Infrastructure Directorate HITD Health Information Technology Directorate HMIS Health Management Information System HSDP Health Sector Development Plan HSTP Health Sector Transformation Plan HP Health Post IPLS Integrated Pharmaceutical Logistic System JSC Joint Steering Committee KII Key Informant Interview MEM Medical Equipment Management M&E Monitoring and Evaluation MNCHD Maternal Newborn and Child Health Directorate MOTI Ministry of Trade and Industry MSH Management Sciences for Health MOF Ministry of Finance MOH Ministry of Health (Federal) MSDG Medical Services Directorate General PCD Partnership and Coordination Directorate PLMU Pharmaceuticals Logistics and Management Unit PMED Pharmaceuticals and Medical Equipment Directorate PFSA Pharmaceuticals Fund and Supply Agency PS Pharmacy Service RHB Regional Health Bureau RDF Revolving Drug Fund RRF Report and Requisition Form SCM Supply Chain Management SDG Sustainable Development Goals SOP Standard Operating Procedure WB World Bank

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

WHO World Health Organization WoHO Woreda Health Office ZHD Zonal Health Department

Executive Summary

Background The Ethiopian government has, over the last two decades, implemented a number of reforms to the national health supply chain to improve the availability of essential medicines and medical devices through establishment or strengthening of key agencies/directorate like Pharmaceutical and Medical Equipment Directorate (PMED) with significant resource allocation for the sector, and to keep pace with the rapid expansion of national health programs. Despite the reforms, significant challenges remain in the sector performance.

Thus, the specific objectives of the assessment are 1) To define PMED’s mandate in the national pharmaceutical and biomedical sector vis-à-vis other players, 2) Identify critical challenges in the organizational structure and capabilities of Ministry of Health (MOH)/PMED and, 3) Provide viable recommendations for improving MOH/PMED’s organizational structure and capacity to assume anticipated roles, strengthen coordination and oversight of national pharmaceutical/biomedical system transformation.

Given this assessment scope is more of organizational capacity assessment, the World Bank capacity development results framework (CDRF) (Otoo et al, 2009) and Organizational Capacity Assessment tool (OCAT) from MSH were adopted and used. The assessment was conducted between June to Mid-September 2020 which is based on qualitative research methods and gathered data from primary and secondary data sources. Data was collected through Key Informant Interview (KII) and Focus Group Discussion (FGD) using the tools developed for this purpose using mostly virtual and few face-to-face approaches due to COVID-19. The source of key primary data was collected through the engagement of about 100 well-experienced leaders and professionals at different positions in the sector, including MOH leadership and Directorates, Regional Health Bureaus (RHBs), Agencies and their subsidiaries, implementing partners (IPs), university, professional associations, and the private sector.

Desk review sources included policy and legal documents, sector strategic plans, performance reports, roadmaps and any other study previously conducted in the sector.

Key Findings With Focus on Major Challenges

● Leadership and governance – There are gaps in clarity about the role and mandate of PMED, which affects the amount of budget allocated and overall attention the directorate receives.

Most respondents felt that PMED lacks staff and leadership experienced in policy level engagement, coordination, and oversight for the sector and thus lacks pro-activeness. On the other hand, the management believes that the MOH plans to conduct Ten-Year Strategic Plan for the pharmaceutical/biomedical sector, in which responsibility has been delegated to EPSA, is considered as misplaced in consideration of PMED’s current capacity.

● Structure and Systems – PMED is one of the 25 Directorates within MOH, reporting to the Medical Services Directorate (MSD). The Case teams have grown to six from the initial three teams, although the new teams remain to be approved by Civil Service Commission. As a result, PMED has not been able to hire additional staff needed and the new teams rely on staff on loan from hospitals. Due to the current structure, PMED does not have access to collaboration and coordination with program Directorates. Second, issues from PMED often require high-level decision beyond MSD’s scope, which causes delay. Third, the structure does not allow PMED to

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector communicate with agencies (EPSA, EFDA and EPHI) directly, as PMED is not represented at the Executive Committee (EC) meeting, which is a higher decision-making body in the pharmacy/biomedical sector led by the Minister.

● Human Resource – The key issues in HR are staff shortages, especially experienced staff within PMED. Given the expanding case teams, there are issues with skill mix, lack of standard mechanisms to orient new staff, ongoing staff development plans, lack of standard job description and limited staff motivation and retention mechanisms. In addition, PMED has quite limited engagement in national level HR planning and capacity building.

● Resource mobilization and utilization – Contrary to the experience within other Directorates, PMED does not engage in resource mobilization in an organized manner. PMED gets a limited budget. Furthermore, PMED has not received approval for the budget it requests to support regions, which could have helped strengthen regional implementation. PMED utilizes the entire allocated budget. The reasons behind low budget allocated for PMED include lack of clarity on its role within MOH, prioritizing support to programs among donors, PMED’s lack of engagement in resource mobilization, and its capacity to adequately defend its plan against competition from EPSA and EFDA though it may needs further study if the allocation was evidence-based/workload related or not.

● Partnership, external relations and networking – Given that PMED is structured under the MSD, which is responsible to oversee and support curative care, there are no formal platforms and mechanisms for planning, communication, and collaboration with program units. Similarly, lack of formal communication and collaboration platforms are a common challenge for interactions with the Agencies, regions, and private pharmaceutical sectors including local manufacturers.

● Regional level PMED equivalent and subsidiaries - The pharmaceutical and medical device unit has different structures, naming, authority, capacity, scope, reporting line and staffing across the regions. There are variations in PMED equivalent structures, capacity, and scope across regions. With regard to staffing, regions are able to fill only about 50-70% of their allowed staffing need. The structures suffer hugely from the cumulative effect of lack of decision-making power (no strong leadership, management, or governance), lack or shortage of operational budget, shortage of staff (even as per allowed structure), and narrowing structure at zonal and woreda level. There is problem in mandate clarity among stakeholders (PMED and EPSA subsidiaries) on leading in quantification, capacity building and SS. There are huge gaps in collaboration for proper forecasting and supply planning, inventory management and enforcing M&E for LMIS implementation for essential medicines and medical devices among key stakeholders.

● Role demarcation – One of the main undertakings of this assessment was a mandate analysis exercise with PMED, EPSA, EFDA and EPHI to clarify roles between the agencies. Based on the KII and FGD discussions, there are problems of role clarity which has a negative impact on their collaboration and has led to a duplication of efforts.

Recommendations Policy and Role demarcation

● MOH/PMED ought to take the leading role in giving policy and strategic direction.

● There are some priority tasks in terms of developing policy and other implementation tools.

First, there is a need to revise Medicine Policy and develop a Medical Device management Policy. Second, a comprehensive road map is required for the pharmaceutical sector, as well as for medical devices with implementation tools.

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

● MOH should give attention to the pharmaceutical and medical devices management sector.

The pharmaceutical and medical device market consumes huge resources which makes it an attractive target for abuse, corruption and unethical practices. MOH and EPSA need to ensure accountability and improve the system for end to end data visibility. There are preceding experiences such as the IBEX system from MOF and also the core banking experience of commercial banks of Ethiopia.

● The roles and responsibilities/mandates & scope of PMED and key stakeholders should be clearly defined, supported with legal framework and communicated to key players in the sector which has a visible positive effect to minimize duplication of efforts and ensure wise use of limited resources. Hence, there has to be revision and endorsement of the legal power of the issued mandates through proclamation.

Procurement and overall Supply Chain Management

● PMED/MOH should support the endorsement currently initiated Procurement law and Directive for Pharmaceutical and Medical Device by EPSA which consider the unique feature of medicine/equipment to improve quality and availability.

● The MOH needs to start developing an option on how to supply commodities which are outside of EPSA’s Pharmacy Procurement List (PPL). This task should start immediately and should be led by PMED.

● MOH/PMED, in collaboration with RHBs, should build the capacity of the RHBs and lower levels up to HFs in the selection, quantification and realistic forecasting considering the available budget. EPSA should focus on procurement and distribution of emergency and routine program and RDF commodities.

● MOH/PMED should support EPSA by coordinating programs drugs quantification, order/follow-up and distribution, allocation and consumption tracking of program drugs and commodities.

● Development and roll-out of Pharmaceutical Sector Transformation Plan (PSTP needs to be shifted to PMED. In summary, MOH/PMED role should be one of facilitating the system while EPSA focuses on its core operation i.e. procurement.

● MOH Leadership should lobby regions to allocate adequate budget for pharmaceuticals in health facilities, prioritize in allocating retained revenue, strengthen their financial management capacity via collection of CBHI arrears, address gaps with fee waiver and exemption service financing and discuss with the treasury in this regard. Simultaneously strengthen the capacity of their HFs to improve their forecasting capacity.

Planning, program Implementations and Performance monitoring

● PMED/MOH should take a leading role for joint planning and performance monitoring implementation with all stakeholder of the pharmaceutical and medical devices sectors

● MOH/PMED should be capacitated and mandated to monitor and evaluate the sector’s overall performance. PMED should revise the existing key performance indicators, then provide orientation to all stakeholders for adoption and implementation.

● Some of the tracer indicators developed in the M&E framework that enable follow-up on sector performance should be integrated into the MOH routine data generation system. Given that the MOH is developing HSTP II, this is an opportunity to incorporate tracer indicators therein.

● There should be harmonization for interoperability of the different available software to minimize duplication of efforts and quality data generation

Resource mobilization and utilization:

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

● PMED should be involved in resource mobilization in a planned and organized manner. Thus, PMED has to design strategy of resource mobilization to its core activities and RHB level PMED equivalent and the subsidiaries.

● MOH should give special attention for evidence-based/workload allocation of both operational budgets and procurement for PMED, agencies and the RHB PMED equivalent subsidiary structures with designing mechanism for sustainability of the budget source.

● The PMED should take a leading role for coordination and supporting the procurement agency and health facilities for the rational use of the allocated procurement budget (prioritization of the budget use to vital and essential health commodities) and timely expense settlement.

Partnership and networking

● Clearly map out the needs for collaboration/coordination forums between the key players, along with the frequency and agenda (PMED with other MOH Directorates, with the Agencies, with key development partners, with RHBs and federal hospitals etc.). To formalize coordination between the Agencies and with RHBs, there is need to sign MOU eventually this might entail proclamation revision of each key stakeholder.

● Related with the previous point, map reporting needs between the various actors in the sector. Such an exercise should be comprehensive to include routine and extraordinary information needs, direction of information flow, frequency, content of the report, reporting format and modality. The result should be approved by MOH leadership and then endorsed at EC and JSC level to get buy-in from all actors.

● Explore potential roles and options of public-private partnership in pharmaceutical and Medical devices management sector. Some options are to explore medical device management and utilization of community pharmacies to expand health service access.

Regional Health Bureau PMED equivalent and subsidiaries:

PMED/MOH is supposed to create accountability or legal framework to link and the support regional level PMED equivalent, Woreda Health Offices and health facilities to strengthen their implementation capacity for sustainable availability and rational use essential medicines and medical devices. Hence, PMED should standardize the structure of RHB PMED equivalent and lower levels with close follow for equipping of the sector with all necessary resources which include HR, operational budgets and implementation tools.

Restructuring

● The last but strongest recommendation from this assessment is restructuring MOH/PMED. The assessment proposes the pharmaceutical and medical devices wing of the MOH to be re-structured to have the maximum required capacity and authority level to address the above mentioned huge and complicated Pharmaceutical and medical devices challenges in phase approaches. The first and immediate actions is strengthening the current PMED with all necessary supports which include HR, budget and other resources to facilitate the smooth transition to the second recommended level of structure (see recommendations section and annex 1 for details) which is at least upgrading to Directorate General. The assessment recommended for restructuring of PMED to the Health Care Commodities and Technologies Directorate General (HCCT-DG). As the transition period could take long time to organize, the quickest action could be taking PMED out of MSD and reporting to state minster. While the assessment fully recognized special and personal level efforts from current MCD-DG is bringing remarkable changes, such short term and long-term restructuring are needed for sustainable change with strong reasons discussed in this document.

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

1. Introduction

1.1 Background to the assessment

Ensuring healthy lives and promoting well-being for all at all ages is one of the Sustainable Development Goals (SDGs) and founding concept of the World Health Organization and the Universal Declaration of Human Rights (WHO, 2016). Realizing this goal requires the existence of a well-functioning pharmaceutical system which ensures equitable access to essential medical products, vaccines and technologies of assured quality, safety, efficacy and cost-effectiveness, and their scientifically sound use (WHO 2007). A pharmaceutical system consists of all structures, people, resources, processes, and their interactions within the broader health system that aims to ensure equitable and timely access to safe, effective services; policy, laws and governance; regulatory systems; innovation, research and development, manufacturing, and trade; financing; human resources; and information.

The Ethiopian government has, over the last two decades, implemented a number of reforms to the national health supply chain to improve the availability and access to essential medicines and keep pace with the rapid expansion—in both scope and scale—of national health programs. Improvements in Ethiopia’s pharmaceutical supply chain have been a key goal of national health development strategies for the last two decades and reforms implemented under Ethiopia’s successive Health Sector Development Program (HSDP) and Health Sector Transformation Plan (HSTP).

Despite the reforms, significant challenges remain in the sectors’ pharmacy service delivery, supply chain and medical equipment management. These challenges were substantiated by different surveys conducted by stakeholders. For instance, the 2018 Integrated Pharmaceutical Logistics System (IPLS) survey documented weighted average stock out rates in 37 essential pharmaceuticals over the six months, before the survey, showed stock-out rates of 27.3%, 24.9%, and 27.8%, for hospitals, health centers (HC), and health posts (HP) respectively (IPLS, 2018), The IPLS also found only 21.8% of hospitals and HC met over 80% of appropriate storage conditions. Recent assessment, by the School of Pharmacy, AAU, has also highlighted persistent weaknesses in core PSCM, PS, and MEM capabilities—and, consequently, performance—under PMED oversight (MOH, 2020).

2. Objectives of the assessment The main objective of this assessment is to examine the role, governance structure, leadership and management systems, available resources, coordination and M&E capabilities of the –PMED in which the assessment is mainly focused on PMED’s organizational capacity. The assessment revisited and defined roles, mandates and responsibilities to enable MOH-PMED to achieve its desired level of performance and its strategic objectives in HSTP II and beyond in partnering with its key stakeholders.

The specific objectives of the assessment included:

● To identify bottlenecks in the environment (internal and external stakeholders) that may impact the effectiveness of MOH-PMED

● To define MOH-PMED’s scope/mandate at the national pharmaceutical and biomedical sector

(national pharmaceutical service, medical devices, and supply chain management, etc.)

● To identify critical capabilities (governance and leadership, structure and system, human resource, resource mobilization and financial capacity, partnership and networking management, planning and implementation capacity) requiring development within PMED to meet revised roles, Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

● To provide viable recommendations for improving MOH-PMED’s capacity and organizational structure, strengthening coordination and oversight of national pharmaceutical system transformation, and—ultimately—driving further progress toward a pharmaceutical system that achieves optimal availability of essential commodities and medical devices and their rational use.

3. Methodology

3.1 Assessment framework

Our priorities in selecting a framework were as follows. First, it should be fit-for-purpose i.e. we were looking for a framework that best explains our study objective. Second, simplicity and ease of understanding and utilizing the framework. Finally, we required a guide that would be comprehensive enough to identify key factors. In this search, the team focused on two dimensions: one, we wanted a guide to assess organizational capacity (that of PMED) that is the core objective of this study. In addition, assessing the extent to which preset goals are achieved due to capacity and effectiveness of the organizational arrangements as well as conduciveness of policy and working environment beyond PMED.

In line with this, we adapted the World Bank capacity development results framework (CDRF) (Otoo et al, 2009) which serves different purposes:

● Analysing capacity constraints and opportunities with respect to any development goal in a country or local context

● Understanding the need for capacity development

● Communicating about the results of capacity development efforts.

This study deals with the first two aspects and we have adapted the framework according to our needs.

According to the framework, the three capacity factors that affect the achievement of development goals are:

Conduciveness of the socio-political environment made up of the political and social forces that determine the priority given to the development goal by the government, the private sector, and civil society.

Efficiency of policy instruments, or the formal mechanisms to be used to guide stakeholder actions toward the achievement of the development goal. Those formal mechanisms include administrative rules, laws, regulations, and standards.

Effectiveness of organizational arrangements, or the systems, rules of action, processes, personnel, and other resources that government and non-government stakeholders bring together to achieve development goals (see figure 1). (Otoo et al, 2009: 11)

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

Figure 1 – Conceptual framework of capacity factors that affect goal achievement

Source: Adapted from Otoo et al, 2009 and MSH, 2013

In order to assess capacity in the stated three dimensions, the CRDF has a defined list of generic indicators that would help measure capacity more objectively. However, these generic indicators have been contextualized to our country setting and to meet this study objective.

One major adaptation of the framework by the assessment team was with regards to the third capacity factor i.e. effectiveness of organizational arrangement. Given that this capacity dimension is the major focus of this study, the team felt this component merited a more in-depth investigation. Hence, we reviewed various organizational capacity assessment tools including those developed by UNDP (UNDP, 2008; 2010), FAO (Kay et al, 2004), USAID (USAID, 2009), FHI (FHI, n.a.), and MSH (MSH, 2013).

The team found the latter tool developed by MSH to be more comprehensive and more appropriate for our context. Thus, to measure the third capacity component (organizational level) the team adapted the Organizational Capacity Assessment tool (OCAT) from MSH. The tool identifies nine dimensions of organizational capacity which we incorporated into our analytical framework (Figure 1).

3.2 Assessment design and approach

3.2.1 Data collection methods

A qualitative research method was used given the nature of the study and relied on primary and secondary data sources. Primary data were gathered from governmental and non-governmental stakeholders at federal level and in selected regions using key informant interviews (KII) and focus group discussions FGD) tools, mostly using virtual due to COVID-19 restrictions and a few face-to-face meetings.

The study was designed, initial debriefing sessions were conducted with MOH leadership to get consensus on the scope and direction of the study. Prior to data collection, a stakeholder consultative workshop was conducted with PMED management and staff to gain insight on their expectations and perspectives on the study. There is a plan to share findings of the assessment to key stakeholders to capture their inputs.

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

Here are details of the major data collection and verification methods employed for the period of June to mid of September 2020:

Comprehensive desk review – Documents that are pertinent for this study were reviewed and relevant information therein were compiled and analyzed. Some of the desk review sources include health policy;

national drug policy; legal documents such as proclamation, regulations and directives; consecutive HSDPs; the HSTP; mid-term review reports; annual performance reports; strategic plans of various Agencies/Directorates; roadmaps; implementation plans and any other study previously conducted on the various aspects of the pharmaceutical and medical devices management sector. In addition, the assessment team reviewed other country experiences and incorporated lessons and best practices in the report. Most of these documents are publicly available, however, some internal documents such as strategic and annual plans, budget information, MOUs etc. were requested and obtained from MOH and other entities to be interviewed.

Key informant interview (KII) - Assessment tools were developed for each of the interview groups (see section 1.5.2.3) tailored to the context and unique data to be generated from each. The detailed interviewee list is presented in (Annex 6 – List of interviewed people) in which about 100 key informants were interviewed. Where feasible, KIIs were administered through email, Zoom or telephone given the current COVID-19 situation. In exceptional cases, face to face interviews were conducted. CHAI regional project staff supported regional level data collection. Hence, training was given to the regional team on the study methodology, questionnaires and overall approach for data collection, verification and compilation. This enabled the entire study team to be on the same page and easing data collection process.

Focus group discussion (FGD) – the team conducted a few essential FGDs despite COVID-19 situation as outlined below: -

● With selected PMED case team leaders to get their views on capacity gaps within PMED, the working environment, management support they receive, reasons behind performance issues within PMED and their recommendation on role definition and reform. In addition, we conducted a mandate analysis exercise with the team.

● With EPSA Directors to discuss challenges in the SCM system, collaborations and coordination with PMED, regions and HFs. A mandate analysis exercise was also conducted.

● With participants from School of Pharmacy (SOP) in Addis Ababa University (AAU) to capture their insight on future directions of the sector.

The KII and FGDs were recorded, and the study team also captured notes while conducting interviews.

The voice recordings were used to strengthen and validate the notes.

3.2.2 Data Sources

Purposive sampling was used to ensure that all relevant respondents were selected to participate within the available resources including time, budget and access for study participants/population. Accordingly, the expected and potential source of information of organizations and key informants to be involved are listed below. The detail list of interviewed people is found in Annex 6 – List of interviewed people. Of these categories.

● Ministry of Health (e.g. health minister, state minister, PMED, different directorates.);

● Federal agencies (EPSA, EFDA, and EPHI)

● Federal hospitals

● Regional (RHB Head/Deputy, PMED structures, EPSA Hub and EFDA Branch)

● Donors and Implementation Partners.

● Professional associations (EPA, Biomedical Engineers and Technologists association)

● Private sector Associations (Manufacturers Association, Importer association)

● Addis Ababa University, School of pharmacy

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

Seven regions were assessed selected purposively:

● The four agrarian regions – Oromia, Amhara, SNNPR, and Tigray;

● City Administrations – Addis Ababa

● Pastoral regions – Afar

● Emerging regions – Gambella

3.2.3 Data analysis

Thematic content analysis method was used to analyses the results of the interviews; identifying, analyzing and reporting on patterns or themes detected in data. Data obtained from the KII were summarized per category or thematic area. Similarly, findings from FGDs were analyzed under each discussion point and most frequent responses, points of agreement among participants and discrepancies or some unique points were identified.

Throughout the data collection and compilation phase, study team members worked together to synthesize and debrief about their ongoing findings, which gave them an opportunity to identify conflicting information, missing data, data that needs further validation and also to pick patterns in findings. After completion of data collection, information gathered from the various sources including desk review, KII and FGD were analysed, triangulated and crosschecked for the validity of findings. The team then produced a summary of key findings, challenges, and recommendations which served as a main base to produce this report. With regards to data generated from regions, a regional summary report was produced for each region. Finally, synthesis was made of the regional reports to produce a triangulated and merged regional finding. This was then integrated into the main report.

3.3 Scope

The assessment attempted to develop a comprehensive understanding of MOH/PMED’s structure, governance, current role, and existing capacity. This included describing MOH/PMED’s current relationships with stakeholders within MOH, with Agencies under MOH, and its engagement with and support to the RHBs and subsidiaries. The assessment examined implications of revisiting MOH/PMED mandates to provide oversight, coordination role and capacity building. The assessment finally produced actionable recommendations that align with long-term goals of improved availability of essential medicines and commodities, improved pharmaceutical service and medical devices management in Ethiopia.

Geographic focus/scope – main focus of the assessment was to look at the performance of MOH/PMED and identified gaps that affect its capacity to meet foreseen objective and role in the pharmaceutical and Medical devices management sector in the future. Hence, the assessment mainly focused on the federal level. However, information was captured in selected regions to assess the situation of pharmaceutical function in the region as well as the structure.

Institutional focus/scope – There are various key actors in the pharmaceutical sector in Ethiopia including PMED/MOH, EPSA, EFDA, EPHI, IPs and many others. This assessment’s central focus was primarily to clarify PMED’s role. However, the interactions and interrelations of stakeholders with PMED’s performance and overall pharmaceutical sub-system in the country was assessed. Nonetheless, the stakeholders’ assessment didn’t go into in-depth role definition or capacity assessment for these other players in pharmaceutical sub-system.

3.4 Limitations

The pharmaceutical sector/system encompasses a broad set of functions carried by various players at the federal level, regional, zonal and down to the smallest service delivery point. However, due to the current COVID 19 situation, mobility and travel to regions and beyond was difficult. Hence, the main level of

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector data collection was focused on the federal level, with limited data collection in selected regions. However, given the objective of the study, this gap is not expected to significantly affect the results /findings of the study. Virtual communication methods were used to get information from a distance. Furthermore, an attempt was made to fill a gap in data about issues at sub-regional and HF levels with desk level review of previous studies.

In addition, due to the nature of the assessment, i.e. organizational capacity assessment, the methodology used is qualitative type and as such cause-effect relationship might not be demonstrated as in quantitative method.

4. Assessment Findings

4.1 Overview of the Pharmaceutical and Medical Devices Management Sector

Despite the fact that access to essential medicines has been declared as a universal right, (WHO, 1978;

OHCHR, 2015), availability of and/or access to safe, effective and quality medicines has been a persistent challenge for most of the developing countries; particularly in Southeast Asia and Sub-Saharan Africa (Ahmadiani and Nikfar, 2016; Ekeigwe, 2019). Globally more than US$ 3 trillion is spent on health services each year. The value of the global pharmaceutical market is estimated at over US$ 600 billion.

Reports show that Africa produces only 3% of the world medicines by volume, however; about 70% of essential medicines for the continent are imported (Mziray, et al., 2017). Nevertheless, Africa has been identified as one of the emerging pharmaceutical market destinations with a value of $US 30 billion in 2016. The market size is predicted to reach $US 45 billion by 2020.

The Ethiopian total pharmaceutical market (public & private) is estimated to value between $800 and $900 million recording a dramatic growth of up to 25% over the last 10 years and predicted to reach to $3.6 billion by 2030 with an annual growth rate of 15% (Umer et al., 2020).

Such large amounts of money is an attractive target for abuse, making the pharmaceutical sector highly vulnerable to corruption and unethical practices. For instance, Transparency International estimates that 10 to 25% of public procurement spending is lost to corruption, and in some countries up to two‐thirds of often scarce medicine supplies at hospitals are lost through corruption and fraud due to lack of strong institution to design and implement country’s specific medicine policy, reforms or strong monitoring system..

Therefore, Governments are obliged to establish and maintain sound institutional structures and policies in a manner that is transparent, accountable, follows the rule of law and minimizes corruption that ensures the effective, efficient and ethical management of pharmaceutical and medical devices management systems promoting accountability of the respective stakeholders involved.. (Annex 4).

4.2 Major Achievements so far

Proclamation No. 471/2005 defined the powers and duties of the executive organs of the Federal Democratic Republic of Ethiopia (FDRE). Accordingly, duties and responsibilities of the Ministry of Health (MOH) include coordination and direction of the country’s health sector development program;

ensure the availability and proper utilization of essential drugs and medical devices in the country; create conducive conditions for research, registration and utilization of traditional medicines; and give the necessary support to practitioners to register and practice; and ensure the carrying out of drug administration and control activities (FDRE, 2005).

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

To that end, cognizant of the pivotal role of pharmaceuticals and health care technologies, there has been a continuous effort from the government of Ethiopia for the Pharmaceutical and Medical Devices Management sector improvement in harmonizing to the rapid expansion in both scope and scale of national health programs in the last two decades specially during the HSDP II. Furthermore, the Essential Health Service Package (EHSP) of Ethiopia boldly recommends for strengthening of the logistics and supply chain management system as one of a key strategic priority area to ensure access to essential medicines and medical devices.

As the result, some of the important reforms in the Pharmaceutical and Medical devices management sector through the implementation of the Ethiopia’s successive Health Sector Development Program (HSDP) and Health Sector Transformation Plan (HSTP) are the establishment or strengthening of key Agencies like EPSA, EFDA, EHIA, EPHI and PMED of MOH which is the center of gravity of this study to achieve the anticipated MOH’s goal. The transformation in health sector has also heavily compelled the Pharmaceutical unit in MOH for series revolution to the current PMED from a time of no unit or focal person to directorate level to support the sector. Moreover, it is denoted as the root cause for dramatic change of EPSA’s capacity to manage a total value of program and RDF pharmaceuticals procurement of about ETB 6.4 billion in 2008 EFY to about ETB 13.2 in 2011 EFY and its annual distribution capacity from ETB 500 million when it was established (2007/8) to over ETB 17 billion in 2011 EFY.

Furthermore, there are a number agencies’ or PMED initiative standards, policy, strategic and implementation tools as a country to strengthening the sector though it may need further study to know about the exact implementation status. Some of the strategic or major reforms include: National Strategy and Plan of Action for pharmaceuticals manufacturing in Ethiopia (NSPA-Pharm 2015-2025), automated LMIS/Dagu, Integrated Pharmaceutical Implementation System (IPLS), quick-win initiative at selected hospitals, Auditable Pharmaceutical Transaction and Service (APTS), Clinical Pharmacy, Drug and Therapeutic Committee (DTC), Drug Information Service (DIS), Small scale hospital compounding, Model Community Pharmacy, Antimicrobial Resistance (AMR) prevention and containment, Traditional Medicine strategy, Computer aided medicines and medical device management information system, Capital Medical Devices list along with their specification, Establishment of biomedical workshops across the country, Curriculum revision to include health care technology management.

Though the implementation status is in question, it is worthful to mention the national medicine policy contents here as follow: The policies and strategies of the government of Ethiopia recognize the importance and role of modern medicine, medical devices and traditional medicine for the wellbeing of Ethiopian citizens. The health policy of 1993 gave direction to strengthen essential medicines, medical supplies, equipment and to promote traditional medicine and incorporate it into modern medicine (TGEa, 1993). Some of the details include:

● Preparing and regularly updating lists of essential and standard drugs and equipment and for all levels of the health service.

● Encouraging national production of drugs, vaccines, supplies and equipment by providing appropriate incentives to firms which are engaged in manufacturing, research and development (R&D).

● Developing a standardized and efficient system for procurement, distribution, storage and utilization of products.

● Developing quality control capability to assure efficacy and safety of products.

● Developing maintenance and repair facilities for equipment.

● Identifying and encouraging the utilization of Traditional Medicine

● Encouraging research for traditional medicine and its linkage with modern medicine.

● Developing appropriate regulation and registration for traditional medicine practice.

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

Initial name/s of the organization and year span

Second name/s of the organization and

Year span

Third name/s of the organization and

Year span

Current name/s of the organization and Year span

Interaction/current major operational areas

The Pharmaceuti cal Supply and Logistic Department (PSLD) from 1993 - 2007

PSLD dissolved for 5 years from 2007 - 2012

Pharmaceutical s Logistics and Management Unit (PLMU) from Aug 2012-Dec 2014

Pharmaceutical and Medical Equipment Directorate (PMED) from Jan 2015 to present

• Oversee and facilitate the smooth implementation of SCM

• Pharmacy service

• Medical devices

• Traditional medicine

The main Pharmacy from 1947 – 1976

Pharmaceutical and Medical Supplies Corporation

(EPHARMECO

R) from 1976 – 1994

Pharmaceutical and Medical Supplies Importer and wholesale Distributor

(PHARMED)

from 1994 -2007

Pharmaceutical Fund and Supply Agency (PFSA) to Ethiopian Pharmaceutical Supply Agency (EPSA) from 2007 – present

• Sustainable availability of essential medicines and medical devices at affordable price

• Supply chain management

• Customer-centered financing and procurement administration

• Fund mobilization and use for implementation

The Pharmacy and laboratory department within MOH from 1964 – 1999

Drug Administration and Control Authority (DACA) from 1999 -2010

Food, Medicine and Health Care Administration and Control Proclamation

(EFMHACA)

from 2010 – 2019

Ethiopian Food and Drug Administration (EFDA) from 2019 - present

• Food safety and quality

• Safety, efficacy, quality and proper use of medicines

• Safety, quality and performance of medical device

• Traditional medicine

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

Institute Pasteur Ethiopia from 1951- 1984

1) The National Research Institute of Health (NRIH),

2) The Ethiopian Nutrition Institute (ENI),

3) The Department of Traditional Medicine (DTM) from 1985 – 1996

Ethiopian Health and Nutrition Research Institute (EHNRI) from 1996 – 2014

Ethiopian Public Health Institution (EPHI) from 2014 - present

• Administering emergency SCM and response

• Administering medical equipment’s/Laboratory

• TA for lab professionals

• Providing training for professionals (capacity building)

• Conducting evaluations and researches on health-related issues

• Traditional medicine

Table 1: summary of PMED and Key Agencies Chronological Events and Interaction in efforts of strengthening Pharmaceutical and Medical Device management process

As part and parcel of the health policy and the economic policy at the time, the Ethiopian drug policy (TGEb, 1993) was devised to meet the country’s demand for essential drugs and to systematize its supply, distribution and use; and to create conducive situations to make the prices of drugs compatible with the people’s purchasing power. Furthermore, the policy aimed to ensure the safety, efficacy and quality of medicines and to develop a domestic manufacturing capacity with gradual supply to the international market. It also pointed out the need to expand manpower training, R&D, design strategy for the integration of traditional medicine in the regular health services after ensuring their safety and efficacy (ibid).

The revised draft Health Policy (MOH, 2019) in the process of endorsement provides clear directions and guidance to embark upon current and future medicine-related services and programs to meet the healthcare needs of the country. One of the major priority areas in the draft health policy is to secure the supply and rational use of medicine and medical device in affordable price and to reduce wastage.

Moreover, efforts will be made to make traditional medicines play positive role in the provision of public health service through strengthening research and development and utilization of their beneficial effects.

The draft health policy also proposed the development or revision of medicine policy and strategy based on the health policy to facilitate the development of the sector (MOH, 2019).

5. Assessment Findings and Discussion

5.1 Historical Evolution of PMED

Although the MOH was mandated to coordinate and monitor the implementation of the National Drug Policy, it did not have the appropriate structure. The Pharmaceutical Supply and Logistic Department (PSLD) was the only pharmacy related Department within the MOH. PSLD had limited capacity and focused more on procurement, distribution and storage and could not adequately assume oversight functions. Both the pharmaceutical and the logistics master plan recommended to strengthen the pharmaceutical sector through reforming the PSLD into National Essential Drug Program Unit (NEDP) within MOH. The NEDP Unit was expected to consolidate Ethiopian Essential Drug Program (or policy) activities and lead the development of policies and legislations; and oversee governance, coordination, harmonization, financing, supply chain, human resource management, R&D and M&E for the sector.

Nevertheless, the recommendation to transform the PSLD into NEDP did not materialize. Instead, the

Comprehensive Assessment of PMED’s Organizational Capacity and Its Role in the Pharmaceutical and Medical Devices Sector

PSLD was dissolved and there remained a gap in pharmaceutical and medical devices support unit within the MOH for five subsequent years (2007-2012). Subsequently in 2012, the mid-term review of HSDP IV identified this major shortcoming within the MOH i.e.