Legislative, policy, and implementation frameworks governing opioid use disorder service delivery in Kenya: a coherence analysis

¹Department of Psychiatry, School of Medicine, Faculty of Health Sciences, University of Nairobi, Nairobi, Kenya, ²Department of Economics and Development Studies, Faculty of Arts and Social Sciences, University of Nairobi, Nairobi, Kenya, ³Mathari National Teaching and Referral Hospital, Nairobi, Kenya

^&Corresponding author
Tina Wakukha Masai, Department of Psychiatry, School of Medicine, Faculty of Health Sciences, University of Nairobi, Nairobi, Kenya

Introduction    

Opioid use (OU) is characterised by use of naturally occurring and semi-synthetic opioids such as morphine and codeine, and synthetic opioids such as heroin, fentanyl, and methadone [1]. Opioid use disorder (OUD) refers to chronic opioid use resulting in clinically significant distress or impairment [2]. In Kenya, all opioids are categorised as first schedule narcotics following ratification of the United Nations Single Convention on Narcotic Drugs in 1973 [3,4], restricting their distribution and use. Although opioids account for only 20% of global drug use, they are responsible for 70% of overdose deaths and 71% of healthy life years lost to premature death and disability [5]. In sub-Saharan Africa, estimated opioid use prevalence is 0.92-1.16% [6], with Kenya's burden partly attributable to proximity to Indian Ocean drug trafficking routes [7]. Despite this burden, only seven sub-Saharan African countries provide both needle and syringe programmes (NSP) and opioid agonist therapy (OAT) [8], interventions with documented reductions in HIV transmission, hepatitis infection, and opioid-related mortality [9,10]. Limited service access in the Kenyan setting is driven not by absent legislation, but rather by restrictive drug policies, limited political will, inadequate funding, and persistent stigmatisation of people who use drugs [11,12].

Data to guide financing and targeted intervention is key. However, OUD epidemiological data in Kenya are fragmented. The National Authority for the Campaign Against Alcohol and Drug Abuse (NACADA) reports a lifetime heroin use prevalence of 0.2% among those aged 15-65 [12], substantially below regional estimates [5]. People who inject drugs (PWID) estimates range from 16,063 to 36,000 [13,14], with methodological variation and the exclusion of those who smoke or ingest non-opioids limiting estimation accuracy. Persons with OUD are predominantly male and low-income, with high rates of incarceration among PWID [15,16], while women who use drugs carry a disproportionate burden of HIV, hepatitis B and C [17,18]. In response to the OUD burden, Kenya initiated methadone maintenance treatment (MMT) in 2010-2011 and by 2025 had established seven standalone MMT programmes integrating HIV prevention, treatment, and psychosocial support [11,19]. For those who access services, outcomes are generally positive, with reduced withdrawals, decreased poly-drug use, improved viral suppression, and high hepatitis C cure rates reported [20,15]. Coverage remains suboptimal at approximately 10-30% [7,9, 21], and the absence of data from rehabilitation centres and general health facilities obscures the true treatment uptake rate.

Given the multi-sectoral approach to management of OU/OUD in Kenya, different legislation, policies and implementation guidelines have evolved under various public health and criminal justice frameworks. These varied legislative and policy instruments are guided by the mandates of their respective authorities. Given that each serves different purposes, the complex multi-sectoral landscapes often contain institutional fragmentation and potentially conflicting mandates. Beyond traditional policy evaluations, a policy coherence analysis offers a useful methodology for evaluating the extent to which these overlapping instruments systematically reinforce one another through synergies or actively hinder progress by creating implementation roadblocks [22]. An analysis of this nature is relevant to the Kenyan context where OU/OUD implementation is addressed across more than one Ministry of Health docket and interior government arms of the national government. No prior analysis has examined legislative, policy, and implementation coherence for OU/OUD management in Kenya. This study thus sought to: (1) identify and analyse existing legislative, policy, and implementation frameworks governing opioid use and OUD in Kenya; and (2) examine coherence of these frameworks in relation to OU/OUD implementation in Kenya.

Methods     

Study design: this study employed a policy analysis design combining document review, policy mapping, and policy coherence analysis to examine the legislative and policy landscape governing OUD service delivery in Kenya. Document review enabled systematic examination of instruments by scope; policy coherence analysis examined convergence and divergence of government instruments as they influence OU/OUD implementation.

The study is grounded in the health policy coherence framework [23-25], which defines policy coherence as the extent to which instruments across governance levels and sectors align toward shared health objectives. Given that authority over OUD in Kenya is distributed across health, law enforcement, and regulatory institutions, this framework directly informs the research question. Policy coherence was operationalised using the interaction scoring methodology developed by Nilsson et al. [26-28], which provides a structured instrument for measuring the degree to which policy instruments reinforce or undermine one another.

Study setting: the study was conducted in Kenya, a country in the east of sub-Saharan Africa. The country has a documented prevalence of 0.2% and an estimated 16,063-36,000 people who inject drugs, the majority of whom inject opioids [13,14]. Governance of OU/OUD interventions in Kenya is distributed across multiple institutions within the Ministry of Health and the Ministry of Interior and National Administration, with implementation decentralized to counties. This is a result of decentralization of health services in 2013 in Kenya [29]. By 2025, there were 35 civil society organizations providing community-based harm reduction and facilitated linkage to methadone maintenance treatment in line with the WHO/UNODC/UNAIDS comprehensive harm reduction standards [30]. The country has also established seven standalone methadone maintenance treatment programmes with additional decentralized sites targeting high-burden areas [31].

Document selection and review: documents were identified through systematic searches of the Kenya Law Reports, Kenya Gazette, and institutional databases of the Ministry of Health, NACADA, National AIDS and STIs Control Programme (NASCOP), and relevant county health departments. Search terms included "opioid use," "opioid use disorder," "substance use disorder," "harm reduction," "methadone maintenance treatment," "medication-assisted treatment," "methadone," "drug policy," and "Kenya."

Searches were conducted in two phases between 27^th April 2025 and 7^th March 2026. Searches were performed manually through structured browsing of institutional websites, publication repositories, and document archives using the search terms above, applied individually and, where free-text search fields were available, in combination. Where an instrument could not be located on a government website, its availability was cross-checked against the websites of implementing partner and donor organisations on which the same instrument had also been uploaded. Any document that was not located through either government or secondary sources was not included in the review. County-level searches were restricted to health department sources in the seven counties hosting standalone methadone maintenance treatment programmes (Nairobi, Mombasa, Kisumu, Kiambu, Kilifi, Kwale, and Lamu), rather than all 47 counties, as county-specific implementation guidance relevant to OU/OUD service delivery was most likely to exist in these counties.

Documents were included if they addressed OU/OUD management in Kenya directly or within broader substance use or mental health frameworks; were published or enacted between 2010-2025 (except foundational legislation); and were relevant to treatment, prevention, harm reduction, or regulation of opioid-related services. Documents were excluded if they focused exclusively on non-opioid substances without OUD relevance, were unofficial drafts, were duplicated by more comprehensive instruments, or were academic or advocacy publications rather than legislative, policy, or implementation documents. Where multiple or outdated versions existed, the most recent version was used. Borderline inclusion/exclusion decisions were adjudicated by the co-authors to ensure consistent application of the criteria across all identified documents.

The timeline of the inclusion criteria was guided by the typical policy lifespan in Kenya (approximately 10 years) and the alignment with the development of implementation and guidelines relating to OU/OU in Kenya. Instruments published or enacted before this period were therefore unlikely to address OUD-specific service delivery directly, other than the foundational narcotics and mental health legislation that predates and underpins the current framework and was retained regardless of publication date.

Documents were categorized into three governance levels: legislative instruments, national policy frameworks, and implementation guidelines governing clinical or programmatic delivery of OUD interventions. Legislative instruments included acts of parliament establishing the legal framework governing narcotics control, mental health treatment, and health service provision. National policies comprised strategic frameworks guiding planning, coordination, and prioritization of services related to substance use disorders, HIV prevention, and drug control. Implementation guidelines included operational protocols directing the delivery of treatment and harm reduction services.

Data collection: data collection was done using a structured data extraction matrix that captured each document's policy level, institutional authority, policy objectives, key interventions, target populations, service delivery mechanisms, and activities, guidance, or recommendations related to OUD. Extraction was performed by a research assistant and validated by the lead investigator. Any discrepancies identified during verification were resolved through discussion between the two, with adjudication by a co-author where consensus could not be reached. The resulting extracted data were organised into a policy matrix to facilitate cross-governance comparison.

Data analysis: content analysis (a research method used to systematically identify, quantify, and interpret patterns, themes, and biases within textual, visual, or audio communication) extracted information on policy objectives, institutional mandates, and measures related to prevention, treatment, harm reduction, and regulation of opioid use. Analysis identified four governance domains: mental health and legislative governance, HIV and harm reduction frameworks, pharmaceutical and professional regulation, and drug prevention and control.

Policy coherence analysis was conducted using the Nilsson interaction framework [26,27]. The framework was originally developed to assess coherence between the Sustainable Development Goals and has since been adapted for cross-sectoral health policy analysis. Analysis is achieved by scoring pairwise interactions between documents on a scale of +3 (indivisible/strongly reinforcing, meaning the instruments are mutually essential and cannot be implemented without one another) to -3 (cancelling/strongly conflicting, meaning the instruments are mutually exclusive). Scores of +1 and +2 reflected enabling and reinforcing relationships respectively, where +1 one instrument creates a favourable, though not essential, condition for the other and for +2 one instrument creates conditions that actively aid implementation of the other; -1 and -2 were categorised as constraining and counteractive respectively (with -1 one instrument sets a boundary condition that limits the other while with -2, one instrument works against the aims of the other, requiring compensatory action). Scores of 0 reflected no meaningful interactions. Interactions were first assessed at the document level and then synthesised across the four identified domains.

For each pairwise comparison, the lead author extracted and reviewed instruments focusing on the wording of objectives, target populations, mandated activities, and stated institutional responsibilities. Also assessed were any policies they were implicitly aligned to. A second reviewer went through all documented scores. Any discrepancies were discussed with reference to the specific clauses of each instrument until consensus was reached. Document-level scores were then summarised narratively within and across the four governance domains to characterise overall patterns of coherence.

Ethical considerations: this study was exempt from ethical review as it involved systematic analysis of publicly available legislative and policy documents only, with no collection of data from human participants.

Results     

Legislative, policy and implementation landscape: out of the twenty-four national instruments identified, a total of sixteen national instruments governing opioid use (OU) and opioid use disorder (OUD) interventions in Kenya were included for analysis, comprising five legislative instruments, six policy frameworks, and five implementation guidelines. A detailed flow chart highlighting the identification, screening, and inclusion is provided in Figure 1. These instruments span multiple governance domains including mental health, HIV prevention, drug control, pharmaceutical regulation, and professional oversight, and are distributed across the Ministry of Health (through the Division of Mental Health, NASCOP, Kenya Medical Practitioners and Dentists Council, and the Pharmacy and Poisons Board) and the Ministry of Interior and National Administration (through NACADA and the Directorate of Criminal Investigations).

Key legislative developments include the Mental Health (Amendment) Act of 2022, which formally incorporates substance use disorders into the national mental health framework, and the proposed Harm Reduction Bill of 2025, which represents the first legislative effort to formalize harm reduction within national health policy. At the policy level, the most recent edition of the Kenya Essential Medicines List published in 2023 marks a significant step in formalizing treatment access by including methadone, buprenorphine, and naloxone as essential medicines for opioid dependence. Implementation guidance is concentrated within the health sector, with five instruments providing operational direction for MAT, drop-in centres, and integrated HIV prevention services. A summary of these instruments is provided in Table 1.

Governance across government entities: governance of OU and OUD interventions in Kenya is distributed across several institutional domains (Table 1). Within the health sector, the Ministry of Health provides overall policy direction through multiple specialized divisions. The division of mental health oversees clinical governance for substance use disorder treatment through the development of national policies and implementation guidelines for the broader substance use disorder management with specialized recommendations relating to OUD management, while the National AIDS and STI Control Programme (NASCOP) and the National Syndemic Diseases Control Council (NSDCC) provide strategic and implementation guidance for HIV treatment and care, where harm reduction services targeting people who inject drugs is expressly defined. Pharmaceutical regulation of opioid agonist therapy is managed by the Pharmacy and Poisons Board, which regulates methadone dispensing and licensing of treatment facilities.

Outside the health system, drug prevention and control policies are implemented by the Ministry of Interior and National Administration through the National Authority for the Campaign Against Alcohol and Drug Abuse (NACADA) and the Anti-Narcotics Unit housed under the Directorate of Criminal Investigations. The Anti-Narcotics Unit is responsible for the enforcement of the Narcotic Drugs and Psychotropic Substances (Control) Act, which includes investigation of drug trafficking and possession offences, seizure of narcotics, and arrest and prosecution of persons found in possession of or trafficking controlled substances. NACADA's mandate, in contrast, focuses on public education and prevention campaigns on alcohol and drug abuse, licensing and regulating alcohol and drug rehabilitation centres, capacity building of addiction professionals, and supporting community-based prevention and rehabilitation programmes. Professional oversight of treatment services is provided by the Kenya Medical Practitioners and Dentists Council, which licenses and regulates treatment institutions.

Policy coherence across government entities: pairwise policy interaction analysis revealed varying levels of coherence across the identified instruments. Strong reinforcing relationships were observed within health-sector governance instruments. The Mental Health (Amendment) Act, Kenya Mental Health Policy, and the National Protocol for Treatment of Substance Use Disorders demonstrated strong reinforcing interactions (+3), reflecting vertical alignment between legislative recognition of substance use disorders and providing evidence-based clinical treatment guidance for the same. Similarly, coherence was observed within HIV policy frameworks. The Kenya AIDS Strategic Frameworks, Key Populations Policy, Drop-In Centre, Standard Operating Procedures (SOPs), Medically Assisted Therapy Implementation Guidelines, and Kenya HIV Prevention and Treatment Guidelines demonstrated reinforcing interactions (+2 to +3) through supporting harm reduction and medically assisted therapy for People Who Inject Drugs within the national HIV response.

In contrast, weaker alignment was observed between public health frameworks and narcotics control legislation. The Narcotic Drugs and Psychotropic Substances (Control) Act demonstrated conflicting interactions (-2) with harm reduction-oriented policies and guidelines, by treating possession, use, and being in locations of drug use such as drug dens with steep fines and imprisonment. The proposed Harm Reduction Bill showed reinforcing interactions (+2 to +3) with health-sector treatment frameworks through delegating national and county functions in harm reduction implementation and clauses pertaining to the provision of harm reduction services. It, however, showed strongly conflicting interactions (-3) with the narcotics control framework, where the penalties are only tied to contravening harm reduction services in the Harm Reduction Bill, criminalization tied to possession and use as per the Narcotic Drugs and Psychotropic Substances (Control) Act. The National Policy for the Prevention, Management and Control of Alcohol, Drugs and Substance Abuse (2025) demonstrated mixed interactions with harm reduction frameworks, aligning more strongly to prevention and demand reduction (-1 to +1). While the policy varied in its qualification of incarceration versus treatment, in relation to the Narcotic Drugs and Psychotropic Substances (Control) Act, it demonstrated an enabling pairing (+1). The policy was, however, silent regarding management of OU/OUD, resulting in a constraining interaction (-1). A summary of these findings is shared in Table 2.

Discussion     

This study examined the legislative, policy, and implementation frameworks governing opioid use and opioid use disorder interventions in Kenya and assessed the degree of policy coherence across these instruments. While Johnson et al. [32] characterize drug policy approaches as a continuum between public health and law enforcement, findings from the Kenyan context reveal a more complex, tripartite structure. The health sector, which encompasses mental health, HIV, and pharmaceutical governance, is mutually reinforcing and largely responsible for the operationalization of OU/OUD interventions in Kenya. Narcotics control frameworks, however, regard narcotic possession as a criminal act subject to a fine or imprisonment, even while providing for referral to treatment. NACADA sits somewhere in between, with a broad legislative mandate encompassing prevention and rehabilitation, yet its policy instruments align more closely with demand reduction and law enforcement, producing inconsistent interactions with harm reduction services. The implication is that OUD services in Kenya function coherently within a health sector silo but exist within a legislative and institutional environment that does not fully support, and in some respects actively constrains, their expansion beyond it.

Crépault et al. [33] offer a useful analytical framework in this regard, distinguishing clinical, public health, and criminal justice approaches as qualitatively distinct orientations rather than points on a single spectrum. This study’s findings suggest Kenya’s HIV-based OUD programming maps most closely onto the public health model, which adopts a population-based, harm-reduction orientation with a limited role for law enforcement, while narcotics control legislation remains squarely within the criminal justice model.

The finding that Kenya's OUD service delivery is primarily embedded within HIV programming is consistent with regional analyses showing that medication-assisted treatment (MAT) scale-up in sub-Saharan Africa has occurred predominantly through HIV prevention platforms targeting people who inject drugs [8,7]. While this approach has enabled the introduction and expansion of OUD-related services, it may also limit integration of addiction treatment within broader mental health and primary healthcare systems. Kenya grapples with sub-optimal coverage of OU/OUD services, yet these gaps are not reflective of a lack of enabling policy - a challenge equally documented in high-income countries [9].

The coexistence of health-based harm reduction pathways alongside criminalization of narcotics possession and use is not unique to Kenya. There is documented negative impact of this incoherence on treatment access and harm-related outcomes including overdose, HIV, and hepatitis C risk, and in extreme cases, increased risk of drug-related mortality [34]. Satcher et al. [35] further show that within criminal legal system settings, evidence-based OUD treatment is variable and frequently secondary to punitive approaches.

Kenya has however made significant strides, notably the integration of methadone, buprenorphine, and naloxone into the Kenya Essential Medicines List - meaningful progress given the United Nations General Assembly Special Session (UNGASS) concern about the persistently low availability of internationally controlled medicines for medical purposes across many countries [36]. United Nations General Assembly Special Session (UNGASS) further documents how stringent access controls designed to prevent diversion, while legitimate, pose additional barriers to decentralized OUD service delivery, a tension Kenya has navigated more successfully than most sub-Saharan African countries but is yet to fully resolve [36]. Kenya is also the only documented country in sub-Saharan Africa providing needle and syringe programmes, opioid agonist therapy, and peer distribution of naloxone at scale, while most others provide none or one or two of these interventions [7]. South Africa is one country to achieve nearly all three, but community distribution of Naloxone is yet to be at national scale [37].

Spatzer [38] document that law enforcement officers face substantial capacity gaps in implementing drug-related legislation in ways that support rather than undermine health objectives, a finding directly relevant to the NACADA-NASCOP interface in Kenya. This is reinforced by calls globally for inclusive, intersectional human rights approaches that extend harm reduction beyond the healthcare system to law enforcement, education, and social sectors. It also necessitates a recognition of substance use disorders as health conditions amenable to evidence-based treatment rather than criminal justice responses [10,32,34,35,39].

Kenya's governance architecture partly embodies this aspiration within the health sector but has not yet achieved the cross-sectoral coherence these frameworks envision. Policy fragmentation extends to implementation, where siloed institutional efforts target the same populations through divergent and sometimes contradictory approaches. Strengthening coordination between the Division of Mental Health, NASCOP, NACADA, and the Pharmacy and Poisons Board, with deliberate harmonization of the Harm Reduction Bill with narcotics control legislation, would constitute a meaningful step toward the integrated, human rights-grounded response that the evidence identifies as both necessary and urgently overdue [9].

Policy implications: several policy considerations emerge from these findings. Improving alignment between public health policies and drug control legislation could strengthen the enabling environment for OUD treatment and harm reduction interventions. Enhanced coordination across institutions responsible for drug policy, mental health, and HIV programming would support a more integrated national response. Finally, with declining donor funding for HIV prevention, treatment, and care, expanding OU/OUD interventions beyond HIV-focused platforms could facilitate greater integration of addiction treatment within Kenya's broader mental health and health system frameworks.

Limitations: this study has several limitations. The analysis relied on publicly available legislative and policy documents and may not capture informal implementation practices or unpublished policy directives that influence service delivery. While the Nilsson interaction scoring provides a structured approach to examining coherence, the scoring process involves interpretive judgement and may be subject to some degree of subjectivity. The analysis focused on national-level frameworks and did not examine county-level policy variation, which may influence OUD service availability across different regions of Kenya. Finally, the study could not assess how documented coherence or fragmentation translates into health outcomes for persons with OUD. Nonetheless, these limitations will not in any way compromise the policy implications of the study.

Conclusion     

Kenya has developed a comparatively robust governance architecture for opioid use and OUD management, with policy coherence within the health sector, most notably within the HIV response. However, structural tensions between health-oriented treatment frameworks and criminalization-based narcotics legislation constrain service scale-up and impede integration into broader primary healthcare and mental health systems. With the proposed Harm Reduction Bill presenting a window for legislative reform and donor funding for HIV programmes declining, the deliberate alignment of drug control, mental health, and harm reduction frameworks is both an urgent priority and an achievable one.

Competing interests     

The authors declare no competing interests.

Authors' contributions     

Tina Wakukha Masai, Martine Odhiambo Oleche, and Teresia Mutavi conceived the idea; Tina Wakukha Masai conducted the document review, initial analysis, and wrote the first draft; Mary Wangari Kuria, Martine Odhiambo Oleche, Teresia Mutavi, and Simon Njuguna Kahonge supervised, validated, and reviewed the writing and provided edits. All the authors read and approved the final version of this manuscript.

Acknowledgments     

The authors would like to acknowledge all legislators and policy makers that brought these documents to life.

Tables and figure     

Table 1: legislative, policy and implementation instruments governing opioid use/opioid use disorder service delivery in Kenya, by governance domain and institutional authority (N=16, 1994-2025)

Table 2: pairwise policy coherence interaction scores using the Nilsson framework for analysis of instruments governing opioid use/opioid use disorder service delivery in Kenya (N=16)

Figure 1: flow diagram for the identification, screening and selection of national instruments governing opioid use/opioid use disorder service delivery in Kenya, 2026

References