Challenges for sustainable healthcare waste management in Ethiopia: a qualitative investigation of gaps in policy and regulatory framework Open Access

HCWM

Healthcare Waste Management

JMP

Joint Monitoring

OECD

Organisation for Economic Cooperation and Development; Program

KI

Key Informant

SDGs

Sustainable Development Goals

SPSS 20

Statistical Package for Social Science

U.S

United States of America

UN

United Nations

WHO

World Health Organisation

Healthcare waste is comprised of wastes generated during the provision of medical care and related activities within a healthcare facility, ranging from the smallest nursing home to sophisticated/advanced medical care centres. Healthcare waste can be broadly categorised into non-hazardous and hazardous types, with non-hazardous waste and hazardous waste accounting for 85 and 15% of the total healthcare waste, respectively (World Health Organization [WHO] 2024). These wastes constitute approximately 1–2% of global waste generated by human activities. Population growth coupled with rising demands for health services and the advancements in care contributes to the generation of large quantities of hazardous waste globally (Thakur & Ramesh 2015; Janik-Karpinska et al. 2023).

Effective Healthcare Waste Management (HCWM) is a key objective in delivering quality healthcare services, ensuring that the social, economic, and environmental benefits of service delivery outweigh any potential harm (Thakur et al. 2021). The United Nations Sustainable Development Goals (UN SDGs) target 100% coverage of basic waste management, which includes healthcare waste. However, according to the Joint Monitoring Programme (JMP), only a quarter (25%) of healthcare facilities had basic waste management in place in 2023, leaving 1.5 billion people served by healthcare facilities lacking these basic waste management services globally. The situation is worse in sub-Saharan African, where only 26% of healthcare facilities have basic HCWM services (Joint Monitoring Programme [JMP] 2024).

Studies suggested that multiple factors contribute to the low coverage of basic HCWM services, especially in developing nations. The main barriers include limited policy (e.g. policies, regulation, guidelines) and regulatory frameworks (Chauhan & Singh 2018), lack of awareness about the impact of healthcare waste (Yazie et al. 2019), perceptions and attitudes towards HCWM (Conti et al. 2024), inadequate training in proper waste management (Mohammed et al. 2021), the absence of waste management and disposal systems, inaccessibility of HCWM technologies (Hassan & Shareefdeen 2022), and insufficient financial and human resources allocation (Chisholm et al. 2021).

Healthcare facilities in developed nations generate significantly higher amounts of healthcare waste than those in developing countries. Additionally, HCWM practices are more advanced, with nearly 100% coverage of basic waste management services (Minoglou et al. 2017; Janik-Karpinska et al. 2023; Joint Monitoring Programme [JMP] 2024). Evidence indicates that this success is primarily attributed to the presence of proper policy and legal framework, as well as the strong and stringent regulatory framework that is in place for managing HCWM (Haylamicheal & Desalegne 2012; Janik-Karpinska et al. 2023; World Health Organization [WHO] 2024).

Ethiopia has the highest healthcare waste generation rate, at 1.1–1.8 kg/bed/day, of all African and developing nations (Minoglou et al. 2017; Janik-Karpinska et al. 2023). Moreover, the country's overall waste management practices are poor, with a magnitude of 52.86% inadequate waste management (Atalay & Gelaw 2024). Improper waste segregation practices result in the mixing of infectious and non-infectious wastes, leading to an infectious waste generation rate between 21 and 75%. The treatment and disposal systems are also very rudimentary and unscientific (Yazie et al. 2019). According to the JMP report, basic waste management service coverage in 2023 was 32%, with 42 and 20% among healthcare facilities in urban and rural areas, respectively (Joint Monitoring Programme [JMP] 2024).

Many studies in Ethiopia have assessed the magnitude and factors influencing HCWM practices. These studies identified several factors influencing HCWM, including the presence or absence of guidelines and policies within the facility, regulatory inspection, staff training, knowledge and awareness, professionals' and leaders' attitude, commitment of professionals and managers, a lack of adequate resources, and negligence (Endris et al. 2022; Mitiku et al. 2022; Shemeles 2022; Wassie et al. 2022; Atalay & Gelaw 2024).

Of the recurrent reports identifying policy and regulatory frameworks as a main factor, only the one conducted by Haylamicheal & Desalegne (2012) investigated HCWM policy and regulatory frameworks. However, this study used only a desk review method to examine the availability of policy and regulatory framework, which didn't allow for a critical exploration of policy and regulatory gaps. Furthermore, the study didn't investigate the factors influencing these gaps. Therefore, this study aims to critically assess policy and regulatory gaps within the HCWM system and the factors influencing them in Ethiopia, triangulating desk review and a phenomenological study design.

The study was conducted in Ethiopia. The country is located between the equator and the Tropic of Cancer, specifically 9.1450° N and 40.4897° E in the Horn of Africa with a total area of 1.1 million km². The national access to primary health care in 2021–2022 was more than 90%, with a universal health coverage (UHC) service coverage index of 43% (Ethiopian Public Health Institute [EPHI] et al. 2023). The country is the second most populous nation in Africa, with a projected population of 135,472,051 in 2025. The country's health system is organised into three tiers, i.e., primary-level healthcare (health posts, health centres, and primary hospitals), secondary-level healthcare (general hospitals), and tertiary-level healthcare (specialised hospitals). In 2022, there were 353 public hospitals, 3,706 public health centres, and 17,561 health posts. In addition, there are also more than 5,000 other government health facilities, private for-profit, and private-not-for-profit health facilities that provide preventive and curative health services (Tadele et al. 2022).

The principal investigator (PI) conducted a desk review to identify relevant policy and regulatory framework documents on HCWM. These documents were sourced from the websites of the Ethiopian Ministry of Health, the Ethiopian Environmental Protection Authority, the Ethiopian Food and Drug Authority, and other relevant websites. Data were extracted using a template prepared in Microsoft Word.

A qualitative phenomenological study was conducted from November 6 to 26, 2024 in Addis Ababa Town, where the Ministry and authority offices are located. Study participants were purposively selected based on their expertise in HCWM policy formulation and regulatory system within the Ethiopian Ministry of Health (Regulatory body, WASH and IPC directorate) and the Ethiopian Environmental Protection Authority. The organisations were selected based on their responsibility for policy formulation and regulation of HCWM at the national level.

The data was collected through individual key informant (KI) interviews using a semi-structured topic guide developed after reviewing the literature. The topic guide was initially prepared in English and then translated into Amharic. A total of seven experts participated in the study until data saturation was achieved. Data saturation was determined through a multi-stage process: each interview was transcribed and translated immediately afterward, followed by thematic analysis to identify codes, categories and themes. Data saturation was determined when a redundant pattern of ideas became evident. The PI conducted the interviews in Amharic to facilitate open dialogue and clarity between the interviewer and interviewee, as Amharic is the lingua franca for both parties. Interviews were conducted after clearly explaining the purpose of the study to the key informants.

The interviews were audio-recorded after obtaining verbal informed consent from the interviewee, and the PI took notes during each interview. The audio records were transcribed and then translated into English for analysis. Data were analysed using Open Code Version 4.03 software. The study utilised an inductive thematic analysis method. Initially, the PI familiarised himself with the data by reading and rereading the translated transcriptions and notes taken during the interviews multiple times immediately following each interview session. The transcript was then coded line by line to generate initial codes. Similar codes were collated and sorted to form broader categories, where similar codes were grouped to identify broader patterns and relationships within the data. These categories were then grouped into much broader themes. Finally, the themes were defined and named to provide a meaningful representation of the data. To support the thematic analysis verbatim quotes were used to directly reflect the ideas of the interviewees.

The study was conducted by the principle of the Declaration of Helsinki. Ethical clearance was obtained from the Institutional Review Board of the College of Social Sciences at Addis Ababa University. A support letter was obtained from the Centre for Sustainable Development, Addis Ababa University to facilitate data collection from the selected ministries and authorities. Before initiating data collection, the PI contacted the relevant directors to obtain permission to collect data. After obtaining permission, experts were recruited based on their level of expertise. The PI clearly explained the purpose of the research and assured the confidentiality of the information provided. Then, the interviews were undertaken after obtaining verbal informed consent from each participant. To maintain confidentiality, the PI personally handled the transcription and translation of all interviews. In addition, all data were securely stored in a password-protected folder accessible only to the investigator. Furthermore, anonymity was ensured by assigning unique identifiers to each study participant in both the transcripts and the final report.

The desk review result showed that the country has policy and regulatory documents and structures relevant to the HCWM system. The review indicated that the policy and regulatory documents are issued by different institutions or bodies of the government including the House of People's Representatives, the Council of Ministers, the Ethiopian Ministry of Health (MoH), the Ethiopian Federal Environmental Protection Authority (FEPA) and the Ethiopia Federal Drug Authority (FDA), Institute for Ethiopian Standards. Furthermore, the implementation of these policy and regulatory documents is monitored by different institutions. Article 92 (sub-articles 1–4) of the 1991 Constitution of the Federal Democratic Republic of Ethiopia outlines the nation's environmental objectives. The existing policy and regulatory frameworks of HCWM are grounded in this constitutional provision. It mandates the protection of the environment from any harm during the design and implementation of any development project. Moreover, it affirms the right of every citizen to live in a clean and healthy environment.

The country issued a National Environmental Policy in 1997, which indicates the need for integrated environmental management. This includes the proper management of waste from all manufacturing and service delivery sectors, including the healthcare delivery system. Proclamations followed the policy, and the available proclamations provide a general legal direction for the enforcement of mitigation and proper management of hazardous wastes. However, no proclamation directly addresses the management of healthcare waste.

Some of the policy and regulatory documents, the Technical Guideline on the Environmentally Sound Management of Biomedical & Healthcare Waste, the Medicine Waste Management and Disposal Directives, and the HCWM Manual for Ethiopia, have similarities and overlapping aspects in their scope. However, the guidelines are issued and monitored by different institutions. Furthermore, there are three guidelines, i.e. the Healthcare Facilities WASH Guideline, the HCWM Manual for Ethiopia, and the Infection Prevention and Control Guideline issued by the Ministry of Health, where different departments are responsible for monitoring the implementations (Table 1).

Almost all the participants mentioned that, even though the overall HCWM practice in the country is improving over time, the practice observed in most health facilities is not satisfactory as per the standards and guidelines set for best practices. One of the participants mentioned that:

The participants also agreed that the overall management practice among the governmental and private health facilities is almost similar.

The participants asserted that one of the main problems in the management system is observed in the segregation of wastes at the point of generation, which is critical for the proper treatment and disposal of wastes.

The other critical problem within the HCWM system is the treatment and disposal of wastes.

The key informants revealed that, despite many gaps, policy and regulatory frameworks for HCWM exist, with different responsibilities distributed across various ministries and authorities. These frameworks are grounded in the 1991 Constitution of the Federal Democratic Republic of Ethiopia. The constitution grants every citizen the right to live in a healthy environment free from any health hazard. This constitutional provision led to the formulation of the 1997 National Environmental Policy, which subsequently facilitated the development of numerous proclamations, regulations, guidelines, and standards.

In addition, the National Infection Prevention and Control Policy recognizes HCWM as a critical component of infection prevention. The country has also developed a National Infection Prevention and Control guideline, which incorporates waste management as a key element. Furthermore, there are specific guidelines for HCWM, such as the National Healthcare Waste Management Manual and the National Healthcare Facilities WASH Guideline.

There are designated authorities and units within various ministries, with delegated offices at regional, zonal, and local levels, responsible for overseeing the waste management practice of both public and private healthcare facilities. These organisations operate with their own independent monitoring and evaluation tools, standards and Standard Operational Procedures (SOPs), which guide and support the regulatory process to ensure safe and effective waste management.

The findings from the KI interviews identified several critical gaps in the policy and regulatory framework which are thematically analysed below.

The interviewees asserted that certain healthcare waste management guidelines, standards, and checklists are very fragmented. According to the participants components of healthcare waste management are dispersed across multiple documents, with different aspects addressed separately rather than being consolidated into a comprehensive document. This fragmentation can pose challenges during implementation, as stakeholders must navigate across multiple resources to fully understand and follow best practices.

The unavailability of some key policy and regulatory documents was highlighted as a major gap in the existing policy and regulatory framework. Participants emphasised that most of the available documents related to healthcare waste management are non-binding in nature. As a result, regulatory bodies often face difficulties in taking appropriate measures, as there is a lack of clearly defined and enforceable grounds for intervention.

Policy and regulatory documents should be revised periodically to fit the latest developments in the field. However, some of the policy and regulatory documents relevant to healthcare waste management were prepared a long time ago and have not been revised since then and are not aligned to contemporary scientific development, limiting their effectiveness in addressing today's challenges.

The key informants ascertained that there is no system for monitoring and evaluation of the effectiveness and timeliness of policy and regulatory framework. Without such a system, it becomes difficult to assess whether the policies are achieving their intended objectives or to identify areas requiring adjustment or improvement. One of the informants noted that

The interviewees revealed that different ministries have separate units responsible for different aspects of healthcare waste management, each operating independently in policy framework formulation and regulation without a unified strategy and plan. The participants identified this fragmentation as the main challenge for policy and regulatory framework.

Multiple stakeholders are involved in healthcare waste management, including healthcare facilities, the community, legislative and executive organs of the government, and other private and non-governmental organisations. However, these stakeholders are not coordinated and this lack of coordination results in ineffective implementation of policies and regulations, leading to inadequate waste management practices.

Formulating an effective and efficient policy and regulatory framework requires well-trained professionals. Moreover, making the regulatory system more precise, especially when it requires laboratory measurement, demands experts in handling advanced monitoring tools. However, participants noted that there are only a few professionals with the necessary training to operate sophisticated laboratory equipment.

The process of formulating, revising, monitoring and evaluating policy and regulatory frameworks is resource intensive. Additionally, the regulatory system relies on field visits which require continuous data collection from healthcare facilities. Participants highlighted that, despite the high cost of these activities, there is limited budget allocation to support them. This financial constraint hampers not only the effective development and revision of policies, but also the consistent regulation of healthcare facilities, ultimately affecting the overall effectiveness of waste management efforts. One interviewee noted that

All interviewees mentioned that the lack of well-equipped and organised laboratories is one of the factors contributing to gaps in the policy and regulatory framework. The participants emphasised that effective policy formulation and regulatory systems should be grounded in evidence to effectively address the problem on the ground. Relying solely on checklist based regulatory systems was seen as insufficient. One participant mentioned that

The lack of active engagement from key stakeholders, particularly higher educational institutions, is considered a significant barrier to the adoption of an effective policy and regulatory framework. One of the experts from the KI interview mentioned that

Communication among relevant stakeholders is limited. There is no established platform or channel through which stakeholders regularly exchange information on regulatory findings or share new scientific developments. This lack of communication weakens collaboration and makes it difficult to incorporate current knowledge into the formulation and revision of policy and regulatory documents. One participant mentioned that

The study examined the challenges for sustainable healthcare waste management in Ethiopia. It explored the availability of healthcare waste management policy and regulatory frameworks and identified existing gaps within the frameworks. Additionally, the study investigated the underlying factors contributing to these policy and regulatory framework gaps.

The study revealed that the country has a policy and regulatory framework on healthcare waste management that had been prepared and issued by different ministries and bodies of the government. In contrast, results from a policy document review on healthcare waste management conducted in Ethiopia showed that the country had a long-adapted policy and regulatory framework that directly and indirectly addresses healthcare waste management (Haylamicheal & Desalegne 2012).

The study highlighted that, despite the existence of a policy and regulatory framework for healthcare waste management over the past three decades, significant shortcomings remain. One key issue identified was a gap in document coverage, largely attributed to the fragmentation of policy and regulatory documents. Consistent with these findings, a study conducted in China found that policy and regulatory documents are developed by various government bodies, ranging from federal ministries to provincial authorities. This fragmentation contributes to inconsistencies in healthcare waste management practices across provinces (Zhang et al. 2014). In most cases, such fragmentation of policy frameworks is linked to the dispersion of goals and objectives horizontally between ministries and vertically between levels of government, particularly when adopting global agendas into national contexts (Kissinger et al. 2021). Similarly, the policy fragmentation in the current study is likely attributed to the organisational and structural challenges explained by fragmented and overlapping mandates created due to the division of goals and objectives across ministries.

A comprehensive and effective policy and regulatory framework requires legally binding legislation that clearly defines conditions, including mandates, prohibitions, and authorizations to ensure its proper implementation and enforcement. Hence, legally binding legislation provides the necessary enforceability and clarity to guide implementation and ensure that regulatory measures are followed consistently across various sectors and levels of government (Segal 2009). However, the findings of this study revealed the unavailability of legally binding legislation. This was identified as one of the major gaps in the policy and regulatory landscape which hinders the implementation and enforcement of the available healthcare waste management regulatory framework within the country. The evidence from the document analysis also ascertained that there was no legally binding legislation that directly or indirectly addresses healthcare waste management. Similarly, a document review conducted in the United States identified the lack of governmental legislation on circular economy in healthcare as a major policy and regulatory challenge in achieving sustainable healthcare waste management (Mahjoob et al. 2023). The results from this study showed that this gap could mainly be attributed to the lack of expertise in the field and poor budget allocation for the responsible sectors. In addition, fragmented and overlapping mandates coupled with poor coordination and communication among stakeholders can hinder the formulation of a comprehensive policy and regulatory framework.

Periodic and consistent public policy revision and amendment is one of the critical success factors for countries' overall development as the global technological, social, and political realm is changing at a faster pace, especially within the health sectors where technology is both an opportunity and threat (Dogaru 2018; Pollack Porter et al. 2018). The findings of this study confirmed that most policy and regulatory documents were prepared and issued over a decade ago, with the exception of the recently released guidelines by the Ministry of Health. This represents a significant gap, as the rapid advancement of scientific knowledge and technological innovation has introduced new opportunities and challenges that were neither present nor anticipated at the time these documents were developed. Similarly, a study conducted in India revealed that the nation's healthcare policy was developed long ago when the linear ‘take-make-dispose’ model was the predominant waste management strategy. This policy lacks a contemporary circularity assumption and no revision has been made since then (Nath et al. 2025). Hence, these outdated policies and regulatory documents will likely fail to address contemporary challenges, such as the increasing complexity of healthcare waste as well as limited use of contemporary advanced technologies to mitigate the impacts of healthcare waste management. This clearly depicts the little attention given to the issue by the relevant stakeholders, which can be masked by the fragmented and overlapping structures helping the stakeholders to shift blame against one another.

The study revealed that there was no evaluation and monitoring system in relation to the policy and regulatory frameworks. A report by the Organisation for Economic Cooperation and Development (OECD) found that the absence of a public policy monitoring and evaluation system is the most significant policy gap in many member countries. According to the report, this is mainly due to reasons including a lack of a culture of evaluation, lack of financial and material resources, lack of data for evaluation, and lack of expertise (Organisation for Economic Cooperation and Development [OECD] 2024).

The availability of comprehensive policy and regulatory frameworks is a key success factor for the implementation of efficient and effective healthcare waste management. Ethiopia has significant policy and regulatory framework documents for healthcare waste management, rooted in constitutional principles and supported by various guidelines, standards, and policies. Despite these commitments by the government, critical gaps persist in the policy and regulatory framework. The main policy and regulatory framework gaps include fragmented documents, the absence of legally binding legislation, outdated documents, and a lack of policy monitoring and evaluation systems. Factors like organisational and structural challenges which can be further explained by fragmented and overlapping structures and poor coordination among stakeholders are responsible for these gaps. Furthermore, the absence of professional expertise, a shortage of budget and organised laboratories, little involvement of relevant stakeholders, and poor communication among stakeholders played a pivotal role in the observed policy and regulatory framework gap. Therefore, addressing these gaps requires a multifaceted approach involving the relevant stakeholders. It is recommended that a central policy studies institute be established to lead the research, monitoring and evaluation of policy frameworks nationwide. This would support the development of comprehensive and timely policies. Additionally, there a need to establish a centralised regulatory authority at both the federal and district levels to ensure consistent oversight and enforcement.

I would like to acknowledge the Center for Sustainable Development for providing a support letter for data collection to the Ministries. I am grateful to the authority leaders and experts willing to participate in the study.

The authors declare that there was no funding for the research and the research was performed as part of the employment.

All relevant data are included in the paper or its Supplementary Information.

The authors declare there is no conflict.