Policy & practice

Legal and institutional foundations for universal health coverage, Regina Mbindyo,a Jackson Kioko,b Fred Siyoi,c Stephen Cheruiyot,d Mary Wangai,d Joyce Onsongo,a Annette Omwoyo,e Christine Kisiaa & Koome Miritif

Abstract Kenya’s of 2010 triggered a cascade of reforms across all sectors to align with new constitutional standards, including devolution and a comprehensive bill of rights. The constitution acts as a platform to advance health rights and to restructure policy, legal, institutional and regulatory frameworks towards reversing chronic gaps and improving health outcomes. These constitutionally mandated health reforms are complex. All parts of the health system are transforming concurrently, with several new laws enacted and public health bodies established. Implementing such complex change was hampered by inadequate tools and approaches. To gain a picture of the extent of the health reforms over the first 10 years of the constitution, we developed an adapted health-system framework, guided by World Health Organization concepts and definitions. We applied the framework to document the health laws and public bodies already enacted and currently in progress, and compared the extent of transformation before and after the 2010 Constitution. Our analysis revealed multiple structures (laws and implementing public bodies) formed across the health system, with many new stewardship structures aligned to devolution, but with fragmentation within the regulation sub-function. By deconstructing normative health-system functions, the framework enabled an all-inclusive mapping of various health-system attributes (functions, laws and implementing bodies). We believe our framework is a useful tool for countries who wish to develop and implement a conducive legal foundation for universal health coverage. Constitutional reform is a mobilizing force for large leaps in health institutional change, boosting two aspects of feasibility for change: stakeholder acceptance and authority to proceed.

Introduction strengthen legislative and regulatory frameworks for UHC.4 In this respect, measuring change in Kenya’s health reforms The constitution of a country is its supreme law, which under- would contribute knowledge to advance UHC. pins all other laws as well as citizens’ pursuit of peace, justice On the 10th anniversary of the constitution, we describe and human development.1 Explicit constitutional provisions our efforts to review the status of these health reforms. The on the right to health exist in 28 of 47 Member States of the Health Systems Governance Collaborative,5 in efforts to World Health Organization (WHO) African Region.1 Yet there simplify governance to improve its understanding and appli- is limited knowledge about country experiences with consti- cability, has outlined a three-level approach for assessing the tutionally mandated health reforms, particularly in low- and different elements and levels of governance: structural, process middle-income countries. and outcome. Our paper focuses on structural measures, spe- Kenya’s 2010 Constitution2 replaced the constitution ad- cifically the national laws and governance entities – the public opted when the country gained independence in 1963, creating implementing organizations and formal groupings across the new normative, structural, institutional, policy and adminis- entire health system. The aim of this article is to demonstrate trative standards. The 2010 Constitution provides important an approach to measurement of health-system structure, and opportunities for fundamental reform, through key reform to apply that approach to analyse gaps and generate evidence agents such as independent commissions and a restructured for action to strengthen the structural capabilities in the Kenya judiciary and parliament, among other core institutions, agen- health system. cies and organs in government.3 A key constitutional standard In the following sections we first outline our theoretical requires the state to take policy, legislative and other measures framework on structural reforms in health systems. We then to fulfil its obligations in respect of health. Consequently, in describe the background to Kenya’s health-system reforms 2010 the embarked on a reform of health and the adapted health-system framework that we developed policies, legislation and institutions. The health reforms are to analyse the multi-institutional reforms. Finally, we present complex, with several multistakeholder processes running our analysis and lessons learnt. concurrently, developing various laws and detailing the forma- tion or restructuring of various bodies. The reforms resonate with the high-level declaration on universal health coverage (UHC), which includes a commitment to

a World Health Organization Country Office, UN Complex Gigiri, Block U3, UN Gigiri Avenue, , Kenya. b Kenya Health Professions Oversight Authority, Nairobi, Kenya. c Pharmacy and Poisons Board, Nairobi, Kenya. d Ministry of Health, Nairobi, Kenya. e Kenya Law Reform Commission, Nairobi, Kenya. f Kenya National Commission on Human Rights, Nairobi, Kenya. Correspondence to Regina Mbindyo (email: mbindyor@​who​.int). (Submitted: 31 May 2019 – Revised version received: 1 June 2020 – Accepted: 21 July 2020 – Published online: 3 September 2020 )

706 Bull World Health Organ 2020;98:706–718 | doi: http://dx.doi.org/10.2471/BLT.19.237297 Policy & practice Regina Mbindyo et al. Constitutional reforms in Kenya

Theoretical framework Effective health reforms should Background to reforms include reforming and restructuring There is considerable evidence associat- the institutions through which health The key aspects of Kenya’s 2010 Consti- ing the constitutional right to health with policies are implemented.13 One author tution in relation to health were twofold: better health outcomes.6,7 A significant has described institutions as the rules devolution of power to 47 county gov- association has been found between a of the game – the formal and informal ernments; and explicit provisions on the right to health in a national constitution rules and norms that structure citizens’ right to health. The extent of devolution and reductions in infant and under-five rights, entitlements, opportunities and of administrative functions varies across mortality rates.6 Other researchers found voices.14 A distinction can be drawn sectors. The health functions are exten- that institutional environments shaped between organizations and institutions. sively devolved: the national govern- by a right to health encourage more and Organizations (public or private) are ment is assigned health policy, national better delivery of health services and created to perform defined functions. referral services and capacity-building can partly account for a positive impact Organizations are primarily the agent for for counties; county governments are on health outcomes.7 In this section we institutional change with the emphasis on assigned person-based and public health highlight some key linkages across health the interaction between the rules of the services within their jurisdictions.18–20 rights, health law, health institutions and game (institutions) and the players of the The constitution prescribed mechanisms health outcomes. game (organizations).14 Formal institu- and timelines for implementation of the The rule of law is increasingly rec- tions, the focus of this article, include various constitutional changes, includ- ognized as a determinant of health, and the written constitution, laws, policies, ing a time-limited independent body pivotal to health and development. WHO rights and regulations enforced by offi- to oversee the transition to devolved has observed that most public health cial authorities (public organizations or government. This process entailed the challenges have a legal component and agencies).15 An analysis of institutional development of enabling legislation and that the concept of public health law “in- change includes considering whether a institutions for devolution, including cludes the legal powers that are necessary particular function is necessary or not intergovernmental relations, applicable for the State to discharge its obligation to (for example, the need for an agency to all sectors. The constitution triggered realize the right to health for all members or new patterns of service delivery by a large number of public-sector reforms of the population.”8 Further, it has been organizations). Organizational change, and energized political commitment to argued that the rule of law is a largely however, focuses on internal capacities reforms, including initiatives to stream- unacknowledged prerequisite for a well- (for example, automation of business line the governance of public agencies functioning health system.9 The law can processes or upgrading equipment).16 In- in all sectors, and to prioritize govern- translate vision into action on sustainable stitutional change analysis must be driven ment investments and reforms in UHC, development, strengthen the governance by a focus on desired outcomes: in the agriculture and nutrition, housing and of national and global health institutions case of health, multiple outcomes relat- manufacturing.21,22 and implement fair, evidence-based ing to UHC. Appropriate approaches and To guide the transformation in the health interventions.10 The law can be an tools are needed to analyse and diagnose health sector, the Kenya Health Policy effective tool to harmonize the mandates gaps and to predict further institutional (2012–2030) was formulated23 with of public agencies, clarify functions and change to strengthen the health system policy priorities structured around promote multiagency cooperation; to for UHC.16 We describe an approach to WHO’s six key components of a well- designate the responsible agency to re- analyse concurrent change to multiple functioning health system: (i) leadership solve a particular issue; and to create new health laws and public organizations. and governance; (ii) service delivery; entities to coordinate activities across We also consider social science (iii) health system financing; (iv) health multiple agencies.10 WHO notes that theories related to advocacy and policy workforce; (v) medical products, vac- countries that have achieved UHC have change efforts.17 Among these, the large- cines and technologies; and (vi) health built it on legal foundations, underscor- leaps theory posits that “when condi- information systems.24–26 This six-com- ing that developing and implementing a tions are right, change can happen in ponent structure was adapted for Kenya legal environment conducive to UHC is sudden, large bursts that represent a by highlighting additional policy issues a critical investment.11 WHO highlights significant departure from the past, as and areas for investment. The policy pro- three critical elements to assess country opposed to small incremental changes posed to overhaul the health legal frame- contexts on whether UHC law reform is over time that usually do not reflect a work by installing a new general health feasible: (i) whether there is acceptance of radical change from the status quo.”17 law and specific laws to restructure (or opposition to) the proposed reform; In Kenya, the 2010 Constitution created each component. This comprehensive (ii) whether there is authority to pro- a major shift in feasibility for health legal framework incorporated health ceed (especially authority from political law reforms, which triggered large infrastructure as a seventh component decision-makers); and (iii) whether the changes in policies, laws, institutional (Fig. 2). After the county governments country has the ability to complete the and regulatory frameworks. In Fig. 1, were elected in 2013, the health policy work (the capacity to make, implement we illustrate a theoretical connection was validated and updated to the Ke- and administer laws).12 Using the context between constitutional standards and nya Health Policy (2014–2030),27 and of Kenya, we aim to demonstrate the long-term health-system goals, via ana- health research was added as an eighth extent of feasibility of UHC law reform, lysing institutional change, optimizing component. At various stages, the health and to contribute lessons on the system- the interconnected health outcomes, and ministry established ad hoc technical atic assessment of legal and regulatory rationalizing their assignment to health working groups and formal advisory frameworks for UHC. actors (public and private). panels. These groups act as the primary

Bull World Health Organ 2020;98:706–718| doi: http://dx.doi.org/10.2471/BLT.19.237297 707 Policy & practice Constitutional reforms in Kenya Regina Mbindyo et al.

Fig. 1. Theory of change on translating constitutional standards to health goals

Constitutional standards Rules of the game Immediate goals Intermediate goals Long-term goals (institutional change: envision, Normative, structural, analyse, predict, act) The full scope of interconnected Health investments optimized Healthy people (individuals, institutional, policy and health outcomes (results) households and communities) administrative standards Review, rationalize, delineate are defined across all Health resources aligned to (e.g. bill of rights, state and enact (in national law) health-system building blocks assigned health results Responsiveness obligations, governance) health functions and outcomes (functions) (of duty-bearers to the Each health outcome is concerns of the poor, and the International instruments Define clear roles within health assigned (in legislation) to the Health system performance voice of right-holders) (recognized by the constitution functions for public sector, appropriate institutions(s) or (institutions and individuals) as part of national law) non-state actors (private, organization(s) linked to distinct health results Fair financial contribution nongovernamental (equity, and financial risk Accountability agencies organization, faith-based) Laws, standards and protection) (e.g. constitutional regulations that underpin commissions, auditor-general, Enact explicit and good governance revenue authority, comprehensive rules and anti-corruption agency) accountabilty relationships for health activities and actors

Health institutional Preconditions Constitutional standards transformation (comprehensive health Health system performance goals (policy, legislative and outcomes) (attainment of health outcomes) regulatory changes)

platforms for elaborating the needed work, component-by-component and We developed an approach – the change within the various reform function-by-function, guided by WHO adapted health-system framework – initiatives and for facilitating broad concepts and definitions. which enables a structured, all-inclusive stakeholder engagement and external WHO describes a health system as a framing of health functions, and pro- technical support.28,29 set of interconnected parts that have to motes uniform and coherent analysis to function together to be effective, consist- identify structural gaps across the health Conceptual and analytical ing of all the organizations, institutions, system. We superimposed the core eight framework resources and people whose primary components of the Kenya Health Policy purpose is to improve health.31,32 The 2014–2030 and the four basic health- A major challenge in analysing the multi- WHO framework for health-systems system functions described above. In this institutional change in Kenya was the lack performance assessment identifies way, we created a grid with each cell rep- of a uniform and coherent approach. The four basic health-system functions resenting a distinct health function. Our use of simplistic tools to analyse com- through which health investments flow: framework allows structure and function plex health systems often contributes to (i) stewardship; (ii) resource generation; to converge, giving a perspective of the interventions that upset the equilibrium (iii) service provision; and (iv) financ- health system’s foundational elements of the system, which can lead to policy ing. In this respect, a health system and acting as a tool to visualize change. resistance from stakeholders.30 To align would be considered well performing We used the framework to systematically the health sector with the 2010 consti- when all the relevant organizations, document the national health laws and tutional standards, Kenya’s health policy institutions, resources and people are public bodies (those already enacted and prescribed specific laws to transform functioning together and contributing those in progress) to assess the extent multiple parts of the system, but lacked optimally to attaining three intrinsic of change, diagnose gaps and identify detail on the overall structural design, goals or outcomes: health; responsive- corrective adjustments. Hence, this ar- offering no rationale on the configuration ness; and fair financial contribution.33 ticle is not concerned with monitoring of health functions or the implementing Consequently, health institutional constitutional implementation,34,35 or organizations envisioned to optimize reforms would be expected to optimize assessing whether specific health-system health outcomes across the devolved institutional capabilities to achieve the functions or accountability mechanisms system. Therefore, to analyse what has intrinsic health outcomes by transform- are achieving desired outcomes (such as changed since 2010, we deconstructed ing health functions component-by- access to medicines36 or immunization the health legal (and institutional) frame- component. coverage37).

708 Bull World Health Organ 2020;98:706–718| doi: http://dx.doi.org/10.2471/BLT.19.237297 Policy & practice Regina Mbindyo et al. Constitutional reforms in Kenya

Other authors have observed that Assessment methods 2020 (technical working groups, advi- stewardship is usually the most neglected sory panels or parliamentary bills). To function within health systems, yet it We obtained empirical evidence for this assess the extent of change in the regu- “anchors health to the wider society, assessment from two primary sources. latory sub-functions, we also extracted comprising three broad tasks: providing First, all the authors were closely in- the data on the regulatory bodies formed vision and direction, collecting and us- volved in the health reform processes to date (enacted and in-progress) and ing intelligence, and exerting influence in various capacities, either as govern- mapped these onto the seven regulatory through regulation and other means.”38 ment planning experts or as technical spheres.39 The sub-function of regulation has been advisors, engaging through the technical discussed when describing the complex working groups and advisory panels. Legal and institutional health-care regulatory system in the Second, we analysed various documents changes United States of America. Seven distinct including national policies, legislative areas of regulatory focus were identi- instruments (laws, executive orders, Before the 2010 Constitution, Kenya’s fied,39 all addressing three competing legal notices and legislative bills). We health system was managed centrally health outcomes (access, quality and identified all the instruments enacted for by two health ministries and governed costs). These seven regulatory spheres purposes relating to health, as published through the Public Health Act of 1921 are essentially a subset of our adapted in the official Kenyan Government web- and other statutes governing specific framework since they relate to WHO’s site.40 We then compiled a chronological functions. A total of 28 public bodies concept of health stewardship, and list of these legislative instruments from existed (in the statutes), although three they align with WHO’s six core health- 1921 to June 2020. For each instrument of these were not currently operating, system components. The spheres exclude listed, we reviewed the legal text and and we could not ascertain whether health leadership (responsible for overall identified two attributes: public body they had ever been constituted (Table 1). stewardship), and the other five compo- created and health function assigned. Shortcomings of the pre-constitution nents are subdivided and expanded to We then mapped all the bodies onto health structures were that institutional distinguish the perspectives relating to the adapted framework according to as- change was largely aligned to vertical health regulation. Thus, health business signed function to see which governing public health programmes or to health relationships, public health and health entities and implementing organizations professions. In particular, health profes- research are distinct regulatory com- are in place and functional. We created sional bodies regulated most aspects of ponents. Our discussion will therefore two profiles: pre-constitution and post- health in a cadre-centric model, creating highlight two stewardship sub-functions: constitution. Similarly, we mapped the a disproportionate focus on professional overall system design and regulation. initiatives that were in progress by June practice, with virtually no balancing

Fig. 2. Comprehensive health legal framework for Kenya

Specific laws General health law Health-related laws

Health financing

Health leadership Legal provisions on • Economy and employment • Overall purpose of health legislation • Security and justice Health products • Scope of health legislation • Education and early life • Health services • Agriculture and food Health information • Health risk factor services • Nutrition • Harmonizing with content of existing health-related laws • Infrastructure, planning and transport • Environments and sustainability Health workforce • Housing • Land and culture • Population Service delivery systems

Health infrastructure

Regulations

Source: Kenya Health Policy (2012–2030).23 Notes: The Specific laws column is the same as the World Health Organization Key components of a well functioning health system24 with one additional component (Health infrastructure). After the onset of devolution, the health policy was subsequently updated to the Kenya Health Policy 2014–2030, which includes Health research – an eighth building block. For purposes of our analysis, our framework corresponds to the eight building blocks, and also separates Service delivery systems into two parts: person-based and population-based services (Table 1; Table 2).

Bull World Health Organ 2020;98:706–718| doi: http://dx.doi.org/10.2471/BLT.19.237297 709 Policy & practice Constitutional reforms in Kenya Regina Mbindyo et al. . .) ( continues Notes All public health-care facilities (except All public health-care facilities (except managed hospitals) were the two referral the two ministries by of centrally MinistryThe Health of Public health. for responsible was and Sanitation and dispensaries; health centres rural and Ministry of Medical Services was health The hospitals. for responsible not established as distinct facilities were legal entities The National Public Health Laboratory Public National The the MinistryService by created was of as a health Health, and is considered ministry administrative entity for purposes The Pharmacy and Poisons Board is listed is listed Board PharmacyThe and Poisons twice established with because it was the from a dual regulatory mandate and pharmacy and poisons, outset (drugs practice) various medical in the offered Courses the respective by approved schools are Kenyan and councils: boards professional and Dentists Medical Practitioners and Pharmacy and Poisons Council, Board NA The two health ministries were created created two health ministries were The as part of an expanded cabinet the established government coalition National of the Kenya after the signing Accord Dialogue and Reconciliation 2008) (February provision Delivering services:Delivering Semi-autonomous referral referral Semi-autonomous hospitals: National • Kenyatta Hospital (1987) and Teaching • Moi Hospital (1998) Referral health • Hospitals, and dispensaries, centres by managed centrally health ministry None None None None and training Creating resources: investment investment resources: Creating Various bodies Various hospitals are referral The • Other facilities. public teaching hospitals also act as learning (pre- clinical training for centres service and in-service) None • 7 university schools (various years): 4 medical schools 2 dentistry schools 1 pharmacy school College Training Medical • Kenya (1991) None • Kenya Institute of • Kenya (1961) Administration Functions and purchasing Financing: collecting, pooling Financing: None None None • National Hospital Insurance • National (1966) Fund None Stewardship: oversight Stewardship: None and councils regulatory boards The • of practice areas their respective oversaw within health facilities and undertook joint inspections • Central Board of Health (1921; not Board • Central operational) Health Laboratory Service Public • National (1923) (1961; not Board Health (Standards) • Public operational) of Mental Health (1991; not Board • Kenyan operational) (1999) Council AIDS Control • National (2006) Tribunal • HIV and AIDS (2007) Board Control Tobacco • professional boards and councils, and councils, boards • 7 professional (i) Pharmacy statute: each established by (1957); (ii) Medical Board and Poisons (1978); and Dentists Board Practitioners (1983); of Kenya (iii) Nursing Council (1984); Board (iv) Radiation Protection Council (1989); Officers (v) Clinical Technicians Medical Laboratory(vi) Kenya (2000); Board Technologists and of the Institute of Nutritionists (vii) Council and Dieticians (2007) None • Ministry of Medical Services (2008) • Ministry Health and Sanitation of Public (2008) Structure and function of public health bodies existing in Kenya before the 2010 Constitution, 1921–2010 the 2010 Constitution, Structure before and function in Kenya of public health bodies existing Table 1. Table Service delivery (person- based) Service delivery (population-based) Health workforce Health-system financing Health-system Core components Core and Leadership governance

710 Bull World Health Organ 2020;98:706–718| doi: http://dx.doi.org/10.2471/BLT.19.237297 Policy & practice Regina Mbindyo et al. Constitutional reforms in Kenya

laws or independent authorities to safe- guard consumer interests (such as safety, pricing and confidentiality). In the period since the 2010 Consti- tution was adopted there has been a large increase in the number of health bod- ies. This transformation has included

Notes enactment of eight laws and creation of 65 new bodies (16 national, two in- tergovernmental and 47 county health departments). Seven additional reforms were in progress by June 2020 (Table 2). NA NA NA Laboratory testing is one of the core Laboratory is one of the core testing functions medicines of a national of overlap This regulatory authority. between two bodies (Pharmacyroles Quality and National Board and Poisons to Laboratory) contributes Control conflicts in carryingregulatory out this function in Kenya Transfusion Blood National Kenya The the MinistryService by created was of as a public Health, and is considered purposes. administrative body for a captured reforms health law The the Kenya long-standing advocacy for Service be to Transfusion Blood National statute established by Of the new laws, the Health Act, 2017 was the first major post-indepen- dence health legislation, delineating multiple health functions at the national, intergovernmental and county levels, establishing new bodies and mandating provision others to be enacted. The Act signalled a

Delivering services:Delivering fundamental shift towards cadre-neutral None None None None health stewardship bodies (professions, products and institutions) and a greater focus on consumer aspects within health functions. These multiple reform initia- tives demonstrate significant feasibility for health reforms. By prioritizing UHC reforms, political decision-makers

and training have signalled authority to proceed, and broad acceptance by stakeholders. In some cases we could not ascertain the reasons why a body was non-operational. a body was not ascertain In could why some cases we the reasons 33 The multiple stakeholder engagement Creating resources: investment investment resources: Creating • Kenya Medical Research Medical Research • Kenya Institute (1979) None None • Kenya National Blood National • Kenya Service (2001) Transfusion mechanisms led by the health ministry (technical working groups and advisory panels) enable the articulation of spe- cific reforms within functions, facilitate

Functions consensus-building and isolate conten- tious issues to be resolved. Parliament is actively (but independently) engaged, including sponsoring bills in some and purchasing priority areas (blood services, food and drug regulation), which creates pressure Financing: collecting, pooling Financing: None None None • Kenya Medical Supplies • Kenya Agency (2000) on health stakeholders to fast-track any related reform initiatives. These multiple forces are driving the large-leaps change to a new state of governance arrange- ments for health, aligned to devolution, and to broader government policies (such as governance of state agencies). The function of health stewardship has shown the greatest transformation, with the creation of a steward of stew-

Stewardship: oversight Stewardship: ards (the national health ministry) and delineated stewardship sub-functions Functions are based on WHO’s framework for health systems performance health systems 1999. for assessment, framework WHO’s based on are Functions

24 across the devolved system. Of the 65 • National Council for Science and for Council • National (1977) Technology None None • Pharmacy and Poisons Board (1957) Board • Pharmacy and Poisons Laboratory (1992) Quality• National Control new bodies created, 59 have steward- ship mandates (the other six are con- cerned with creating resources). Of the seven reforms in progress, six involve ) elaborating stewardship sub-functions (the other reform is concerned with a financing function). This considerable change would be expected to enhance NA: not applicable. (WHO) of a Key components Health Organization’s World based on are components Core of Kenya. the 2010 Constitution before of enactment) public health-sector created bodies (and year show framework health-system of the adapted Cells Notes: , 2010. functioning health system well Health research Health infrastructure Health information Health information systems Medical and products technology Core components Core

(. . continued system capabilities in providing vision

Bull World Health Organ 2020;98:706–718| doi: http://dx.doi.org/10.2471/BLT.19.237297 711 Policy & practice Constitutional reforms in Kenya Regina Mbindyo et al. . .) ( continues Notes Three successive Executive Orders on the Orders Executive successive Three (2013, Government of the National structure 2016 and 2018) established a single health ministry and its portfolio have responsibilities not changed fundamentally of the Health Financing recommendations The include the creation ExpertsReform Panel and two scheme, of a social insurance bodies: (i) health financing and independent (ii) health-care services accreditation in the medical schools offered courses The professional the respective by approved are and Medical Practitioners bodies: Kenyan and Pharmacy and Poisons Dentists Council, Board services of the focus are Population-based in vertical donor-funded many programmes Institutional change health sector. Kenya’s a follow to public health tends to relating similar pattern provision Delivering services:Delivering None None None None Creating resources: resources: Creating investment and training investment • Kenya School of Government School of Government • Kenya by (2012), created the Kenya amalgamating Institute of Administration other government and three institutions training None • 4 university schools (various years): 4 medical schools 2 dentistry schools 1 pharmacy school Training Medical • Kenya (1991) College None Functions and purchasing Financing: collecting, pooling Financing: None • Social Insurance Scheme to converting by the be created Hospital Insurance National the Health by proposed Fund, Experts Reform Financing 2019 (in progress) Panel, None None Stewardship: oversight Stewardship: • Ministry of Health (2018) Health Sector Intergovernmental • Kenya (2017) Forum Consultative • 47 county health departments (2013) Health Committee of Governors • Council (2012) • Independent body for health benefit • Independent body for the Health by package proposed design, 2019 (in Experts Reform Panel, Financing progress) Oversight Health Professions • Kenya Authority (2017) (2017) Council Workforce Health • Kenya (in of Kenya • Radiographers Board progress) each or councils, boards • 5 professional Health (i) Public statute: established by Council (2013); Technicians Officers and of Kenya Council (ii) Physiotherapy and Psychologists (2014); (iii) Counsellors, (2014); (iv) Health Board Psychotherapists and Information Managers Board Records Council Therapy (2016); (v) Occupational (2017) of Kenya Institute (2012) Cancer • National Young on Infant and Committee • National (2012) Feeding Child • Health ministry working technical group Health Institute (in Public on National progress) Structure and function of public health bodies created in Kenya after the 2010 Constitution, 2010–2020 the 2010 Constitution, after Structure in Kenya and function of public health bodies created Table 2. Table Core components Core and Leadership governance Health-system Health-system financing Health workforce Service delivery (population-based)

712 Bull World Health Organ 2020;98:706–718| doi: http://dx.doi.org/10.2471/BLT.19.237297 Policy & practice Regina Mbindyo et al. Constitutional reforms in Kenya . .) ( continues Notes The role of the Kenyan Medical Practitioners Medical Practitioners of the Kenyan role The expanded in 2019 was and Dentists Council of health facilities. include regulation to health services (includes regulation However, a to transfer is expected to accreditation) in line with the body, new independent Experts Reform Panel Health Financing under (see above, recommendations financing) and Drug Authority Food Kenya A proposed single regulatory body for is the anticipated parallel Two and technologies. health products authority the proposed create to processes be harmonized: and need to in progress are another led the health ministry, one led by XI of the Health Act, Part parliament. by of human-derived the full scope 2017 covers for but only provides medicinal products, a blood service (Section 85). organization of discrepancy in the scope reflects This which need the two draft bills in progress, harmonizing health has been drafted A bill on electronic of the provisions the relevant implement to 2017 Health Act, Health Policy Although the Kenya as a distinguishes health infrastructure of the regulation component, separate is parthealth infrastructure of health services regulation provision Delivering services:Delivering • Kenyatta National Hospital National • Kenyatta (1987) and Referral Teaching • Moi Hospital (1998) health services• County None None None Creating resources: resources: Creating investment and training investment Various also hospitals are referral The • facilities Otherteaching public hospitals also act as learning clinical training, for centres pre-service and in-service None None None Functions and purchasing Financing: collecting, pooling Financing: None Medical Supplies • Kenya Authority (2013) mechanisms in parallel Two • – both addressing progress XI of the Health Act, Part 2017 on Human Organs, Blood Products, Human Blood, and Gametes: Tissues Other Blood National (i) Draft Kenya and Transplant Transfusion Service Bill (2019, health ministry working technical National (ii) Kenya group); Service Bill Transfusion Blood (2020, parliament) None None Stewardship: oversight Stewardship: • Kenyan Medical Practitioners and Medical Practitioners • Kenyan 2019) (1978, revised Dentists Council • Health ministry working technical group Health addressing on quality of care, for 2017, Sect. provide Act, 15(n), to of health services, towards accreditation body for establishing an independent by health services proposed regulation, Experts Reform the Health Financing 2019 (in progress) Panel, PackagePanel Advisory • Health Benefit (in progress) Technology Reproductive • Assisted Authority (in progress) • 2 parallel mechanisms, both addressing both addressing mechanisms, • 2 parallel 2017, single VII of the Health Act, Part and health products regulatory body for be enacted: (i) health to technologies ministry on working technical group and Drugs Authority (in Food Kenya and Drugs Food (ii) Kenya progress); 2019 (in progress) Authority Bill, • Health ministry working technical group on e-health, 2017, Health Act, addressing XVPart – E-Health, Sect. 104(1), electronic be enacted within to health legislation (in progress) 3 years health services• Independent body for the Health by proposed regulation, 2019 (in Experts Reform Panel, Financing progress) ) Core components Core Service delivery (person-based) Medical products and technologies Health information systems Health infrastructure (. . continued

Bull World Health Organ 2020;98:706–718| doi: http://dx.doi.org/10.2471/BLT.19.237297 713 Policy & practice Constitutional reforms in Kenya Regina Mbindyo et al.

Table 3. Health regulatory bodies in Kenya, June 2020

Regulatory areas Regulatory structures Regulatory bodies (enacted or Legal instrumentsa in progress) Physicians and • Kenya Health Professions Health Act (2017), Sect. 60 (1) other health-care Oversight Authority Notes professionals • 12 professional boards and 12 cadre-centric statutes (1957– councils (self-regulation)b 2017) Hospitals and other • Kenya Medical Practitioners Amendment to the Medical health-care institutions and Dentists Council Practitioners and Dentists Act (2019) • Proposed: independent Health Act (2017), Sect. 15(n); The National Commission for Science, Science, for Commission National The is the successor and Innovation Technology Science and for Council the National to (1977) Technology mechanism for accreditation also recommended by the Health and quality assurance of Financing Reform Experts Panel health services (in progress) (2019) Health-care finance • Proposed: independent Health Act (2017), Sect. 15(n); mechanism for health benefit also recommended by the Health package development (in Financing Reform Experts Panel progress) (2019) provision Drugs and health-care • Pharmacy and Poisons Board Pharmacy and Poisons Act (1957), Delivering services:Delivering products Sect. 3

None • National Quality Control Pharmacy and Poisons Act (1957), Laboratory Sect. 35D; amendment through

33 Act No. 12 of 1992 • Single regulatory body to be Health Act (2017), Sect. 62; two enacted (in progress) Kenya Food and Drug Authority bills developed (health ministry, parliament); need harmonizing Public health • Central Board of Health (not Public Health Act (1921), Cap. 242 operational) Creating resources: resources: Creating • Public Health (Standards) Food, Drug and Chemical investment and training investment Board (not operational) Substances Act (1965), Cap. 254 None • Tobacco Control Board Tobacco Control Act, No. 4 (2007) • National Committee on Breast Milk Substitutes Regulation Infant and Young Child and Control Act (2012)

Functions Feeding • Proposed: National Public Draft National Public Health Health Institute (in progress) Institute Bill (2018) Health-care business • Proposed: independent None

and purchasing relationships mechanism for health benefit package development and

Financing: collecting, pooling Financing: costing (in progress) None Funding of research • National Health Research Health Act (2017), Sect. 93(1) Committee a See also Table 1; Table 2. b A key recommendation of Kenya’s Presidential Task Force on Parastatal Reforms is the de-linking (from government ownership) of all bodies that are funded through members’ fees (member organizations) in

Functions are based on WHO’s framework for health systems performance health systems 1999. for assessment, framework WHO’s based on are Functions all sectors. In the health sector, all the 12 cadre-centric boards and councils fall into this category, but the 24 recommended de-linking has not yet been done. Notes: We based the regulatory areas on the seven spheres of regulatory authority described by Field, 2007.39 The listed structures might not cover all the needed regulatory activities. In some cases we could not ascertain the reasons why a body was non-operational. Stewardship: oversight Stewardship: and direction, collecting and using be formed (for drugs and devices, and intelligence, and exerting influence, health-care institutions); three initia-

• National Commission for Science, Science, for Commission • National (2013) and Innovation Technology all contributing to the achievement of tives are in progress (concerning public desired health outcomes. health, financing arrangements and The seven distinct regulatory com- business relationships). However, two ) ponents are at varying stages of trans- regulatory areas remain fragmented formation (Table 3). Two new regulators (public health and health-care profes- have been formed (concerning health sionals). For professions, five new cadre- professionals and health research); centric bodies were created, resulting in NA: not applicable. (WHO) Health Organization’s World based on the are components June 2020. Core up to of Kenya after the 2010 Constitution of enactment) public health-sector created bodies (and year show framework health-system of the adapted Cells Notes: , 2010. functioning health system of a well Key components Core components Core Health research

(. . continued two new regulators are mandated to a total number of 12 bodies (Table 2).

714 Bull World Health Organ 2020;98:706–718| doi: http://dx.doi.org/10.2471/BLT.19.237297 Policy & practice Regina Mbindyo et al. Constitutional reforms in Kenya

Overall, our analysis revealed the overall design of the health system, leaps institutional change in health, structural gaps or inconsistencies across describing each distinct element, and boosting two aspects of feasibility of many health functions. We noted that, how the various parts should operate conducting health reforms for UHC: when the new laws and bodies were together. By mapping backward from acceptance by stakeholders; and author- created, all the pre-constitution laws the overall health system goals, we ity to proceed from political decision- and bodies (including non-operational need to define the desired outcomes makers.12 The third aspect of feasibility bodies) remained unchanged. Except relating to the distinct health functions, – capability – requires capacity enhance- for two merged health ministries, and then identify actions that are needed to ment and interdisciplinary collaboration minor amendments to other laws, optimize these outcomes across the in- (health, legal and human rights), which these pre-existing structures were not terconnected parts of the health system. promotes mutual learning and unifor- eliminated or consolidated. The inher- We believe our adapted health- mity of actions. Priorities for capacity ent fragmentation has therefore become system framework is a useful tool for enhancement include technical framing entrenched in the system, with the at- countries needing an all-inclusive fram- of reform issues and formulating health tendant inefficiencies (gaps, duplication, ing of health-system structural elements law that is compliant with UHC. Imple- overlaps and conflicts of mandates). A to envision the overall design (future), menting health institutional change re- corrective action is therefore needed to analyse gaps (current) and predict the quires a holistic, big-picture perspective, rationalize and consolidate health func- needed institutional change. In this re- envisioning the overall health-system tions, especially the regulation of public spect, the grid is a versatile tool, to create design as it should be, including the health and health-care professionals. context-specific frameworks, according spatial arrangement of health functions to the health system attribute(s) mapped and the corresponding outcomes. It is Conclusion and lessons onto the cells (laws, bodies, gaps, out- then possible to systematically analyse learnt comes). The various mappings can cre- the structural elements to diagnose gaps ate multiple platforms for engagement, and to predict change. ■ Our approach has enabled us to measure facilitating a holistic approach to health institutional change, diagnose gaps reforms. Acknowledgements and generate evidence for predicting The framework could be a useful We thank: Lucy Musyoka, Pacifica On- further change across the entire health tool for countries wishing to develop yancha, Charles Kandie, Mercy Mwan- system of Kenya. Overall, the multiple and implement a conducive legal envi- gangi, Jared Nyakiba and Mohamed gaps identified across the health-system ronment for UHC. We have been able Sheick, all Ministry of Health, Kenya; components demonstrate the multiple to quantify the extent of institutional Njeri Githanga of the National Council opportunities to streamline health func- change in Kenya’s health system and for Law Reporting (Kenya Law); Gilbert tions across the system. To identify to diagnose gaps for corrective action Kokwaro of Strathmore Business School, strategic options for further institutional to strengthen health functions, but we , Kenya; Elizabeth change, a systematic review of the evi- did not focus on the effects or impact Kamundia of Kenya National Commis- dence is needed, function-by-function, of these changes. We encourage further sion on Human Rights; Helen Kariuki focused on defined outcomes. However, studies to assess the adequacy of laws of , Kenya; and because a national health system is one enacted and the capabilities or actual Nollascus Ganda of WHO Kenya. system with multiple interconnected performance of the bodies created. We parts, any predictions about change in have learnt that a national constitutional Competing interests: None declared. one function require a holistic vision of reform is a mobilizing force for large-

ملخص األسس القانونية واملؤسسية للتغطية الصحية الشاملة، كينيا أطلق الدستور الكيني لعام 2010 سلسلة من اإلصالحات عرب العامة التي تم تنفيذها بالفعل، والتي هي قيد التنفيذ، وقمنا بمقارنة كل القطاعات للتوافق مع املعايري الدستورية اجلديدة، بام يف ذلك مدى التحول قبل وبعد دستور 2010. كشف حتليلنا عن العديد انتقال السلطة ووثيقة شاملة للحقوق. يعمل الدستور كمنصة من اهلياكل )القوانني واهليئات العامة املنفذة( التي تشكلت عرب للنهوض باحلقوق الصحية وإعادة هيكلة أطر العمل السياسية النظام الصحي، مع العديد من هياكل اإلرشاف اجلديدة املتوافقة والقانونية واملؤسسية والتنظيمية هبدف رأب الفجوات املزمنة مع انتقال السلطة، ولكن مع التجزئة داخل الوظيفة الفرعية وحتسني النتائج الصحية. إن هذه اإلصالحات الصحية التي التنظيمية. من خالل تفكيك وظائف النظام الصحي املعيارية، يفرضها الدستور تتسم بالتعقيد. تتغري مجيع أطراف النظام الصحي قام إطار العمل بتمكني رسم خرائط شاملة ملختلف سامت النظام بشكل متزامن، إىل جانب العديد من القوانني اجلديدة التي تم الصحي )الوظائف والقوانني واهليئات املنفذة(. نحن مؤمن بأن سنها، وهيئات الصحة العامة التي تم إنشاؤها. وقد تعرض تنفيذ إطار عملنا هو أداة مفيدة للبلدان التي تريد وضع وتنفيذ أساس مثل هذا التغيري املعقد للتعويق بسبب األدوات واألساليب غري قانوين مالئم للتغطية الصحية الشاملة. اإلصالح الدستوري هو املالئمة. للحصول عىل صورة ملدى اإلصالحات الصحية خالل قوة دفع لتحقيق قفزات واسعة يف التغيري املؤسيس الصحي، مما السنوات العرش األوىل من تطبيق الدستور، قمنا بوضع إطار عمل يعزز جانبني من جدوى التغيري: قبول أصحاب املصلحة وسلطة ّ لمعد للنظام الصحي، يف ضوء مفاهيم وتعريفات منظمة الصحة امليض قدما. العاملية. قمنا بتطبيق إطار عمل لتوثيق القوانني الصحية واهليئات

Bull World Health Organ 2020;98:706–718| doi: http://dx.doi.org/10.2471/BLT.19.237297 715 Policy & practice Constitutional reforms in Kenya Regina Mbindyo et al.

摘要 肯尼亚：全民健康覆盖的法律和体制基础 2010 年《肯尼亚宪法》推动了各部门的一系列改革， 尼亚宪法》实施前后的改革程度。我们的研究结果表 以遵循新宪法标准，包括权力下放和全面的人权法案。 明，整个卫生体系形成多重结构（准则和实施中的公 《宪法》为促进卫生权和调整政策、法律、体制和监 共机构），其中许多新的管理结构与权力下放一致， 管框架提供了一个平台，从而扭转长期差距，改善卫 但在下级监管方面存在分歧。通过解析卫生体系标准 生成效。这些宪法规定的卫生改革很复杂。卫生体系 职责，该框架提供了各种卫生体系属性的详细信息（职 的所有部门同时转型，颁布了若干新准则，并建立了 责，准则和实施机构）。我们认为，我们的框架有助 公共卫生机构。此类复杂变革的实施受到了举措和方 于为某些国家实现全民健康覆盖打下坚实的法律基础 法不充足的阻碍。为了解该宪法前 10 年卫生改革的 并赋予实施。宪法改革可推动卫生体制取得突破性变 程度，我们根据世界卫生组织理念和界定，制定了一 革，增强了变革可行性的两个方面 ：利益相关者的接 个合适的卫生体系框架。我们利用此框架记录已设立 受程度和实施授权。 并正在实施的卫生法和公共机构，并对比了 2010 年《肯

Résumé Fondements juridiques et institutionnels pour l'instauration d'une couverture maladie universelle au Kenya Adoptée en 2010, la Constitution du Kenya a entraîné une série de ont d'ores et déjà été édictées ou sont en cours d'élaboration, et avons réformes dans tous les secteurs afin de les adapter aux nouvelles comparé l'ampleur des transformations avant et après la Constitution normes constitutionnelles, notamment à la décentralisation et à une de 2010. Notre analyse a révélé de multiples structures (lois et organes charte détaillée des droits. La Constitution sert de tremplin pour faire publics de mise en œuvre) réparties dans l'ensemble du système de progresser les droits en matière de santé et restructurer les cadres santé, avec plusieurs nouvelles structures de gestion conformes à la politiques, juridiques, institutionnels et réglementaires en vue de réduire décentralisation mais une fragmentation au niveau de la sous-fonction les disparités chroniques et d'améliorer les résultats cliniques. Toutefois, de régulation. En décomposant les fonctions normatives du système de ces réformes de santé prévues dans la Constitution sont complexes. santé, le cadre a permis d'établir une cartographie globale des différentes Toutes les composantes du système de santé évoluent en même temps, caractéristiques de ce système (fonctions, lois et organes de mise en de nombreuses lois inédites sont promulguées et des organismes de œuvre). Nous sommes convaincus que notre cadre représente un outil santé publique sont créés. L'emploi d'approches et d'outils inadaptés a utile pour les pays qui souhaitent développer et instaurer des bases entravé la mise en œuvre de ces changements si complexes. Pour mieux juridiques propices à la création d'une couverture maladie universelle. La appréhender l'étendue des réformes de santé entreprises au cours des réforme constitutionnelle possède un pouvoir de mobilisation capable 10 premières années de la Constitution, nous avons développé un cadre de faire progresser le changement institutionnel dans le domaine de sanitaire sur mesure, inspiré des concepts et définitions de l'Organisation la santé. Et ce, en renforçant deux aspects qui favorisent sa réalisation: mondiale de la Santé. Nous avons appliqué ce cadre afin de récolter des l'acceptation de la part des intervenants, et l'autorité nécessaire pour agir. données sur les organismes publics et les lois relatives à la santé qui

Резюме Правовые и институциональные основы всеобщего охвата услугами здравоохранения, Кения Конституция Кении от 2010 года инициировала комплекс а какие только находятся в процессе создания, и сравнили реформ во всех секторах, чтобы привести их в соответствие степень преобразований до и после принятия Конституции с новыми конституционными стандартами, включая передачу 2010 года. Как показал анализ, в системе здравоохранения полномочий и всеобъемлющий билль о правах. Конституция существует множество структур (законов и исполнительных действует в качестве платформы для продвижения прав в области государственных органов), при этом большое количество новых здравоохранения и реструктуризации политической, правовой, надзорных структур связано с делегированием полномочий, институциональной и нормативной базы для устранения но внутри регулятивной подфункции существует значительная хронических пробелов и улучшения результатов в отношении раздробленность. Путем деконструкции нормативных функций здоровья. Эти обусловленные конституцией реформы в сфере системы здравоохранения рамочная структура позволила здравоохранения являются сложносоставными. Трансформация выполнить всеобъемлющее картирование различных атрибутов всех частей системы здравоохранения происходит одновременно, системы здравоохранения (функций, законов и исполнительных поэтому было принято несколько новых законов и были созданы органов). Авторы считают, что такая рамочная структура органы общественного здравоохранения. Реализации таких является полезным инструментом для стран, которые хотят сложных изменений препятствовали ненадлежащие инструменты разработать и внедрить благоприятную правовую основу для и подходы. Для получения представления о масштабах реформ в всеобщего охвата услугами здравоохранения. Конституционная сфере здравоохранения за первые 10 лет действия конституции реформа — это движущая сила для значительного продвижения авторы разработали адаптированную рамочную структуру в институциональных изменениях в сфере здравоохранения, для системы здравоохранения, руководствуясь концепциями которая усиливает два аспекта осуществимости изменений: и определениями Всемирной организации здравоохранения. принятие заинтересованными сторонами и полномочия на Эту структуру применили, чтобы документально фиксировать, выполнение. какие законы уже приняты и какие органы уже функционируют,

716 Bull World Health Organ 2020;98:706–718| doi: http://dx.doi.org/10.2471/BLT.19.237297 Policy & practice Regina Mbindyo et al. Constitutional reforms in Kenya

Resumen Fundamentos jurídicos e institucionales de la cobertura sanitaria universal en Kenia La Constitución de Kenia de 2010 generó una serie de reformas en todos leyes sanitarias y los organismos públicos ya promulgados y en curso, los sectores para ajustarse a los nuevos estándares constitucionales, en el que se comparó el grado de transformación antes y después de la incluida la transmisión y una amplia carta de derechos. La constitución Constitución de 2010. El análisis realizado reveló que se habían formado representa una plataforma para promover los derechos sobre la salud y múltiples estructuras (leyes y organismos públicos de ejecución) en todo reestructurar los marcos jurídicos, institucionales y normativos con el fin el sistema sanitario, que tenían muchas estructuras de gestión nuevas de revertir las deficiencias crónicas y mejorar los resultados de la salud. alineadas con la transmisión, pero que estaban fragmentadas dentro Estas reformas de la salud, establecidas por mandato constitucional, de la subfunción de reglamentación. Al desestructurar las funciones son complejas. Asimismo, todas las áreas del sistema de salud se están normativas del sistema sanitario, el marco permitió realizar un mapeo transformando de manera simultánea, ya que se han promulgado completo de los diversos atributos del sistema sanitario (funciones, leyes varias leyes nuevas y se han establecido organismos de salud pública. y organismos de ejecución). Se considera que el marco que se propone Sin embargo, la falta de herramientas y métodos adecuados limitó aquí es un instrumento útil para los países que quieren elaborar e la implementación de estos cambios tan complejos. Se elaboró un implementar un fundamento jurídico propicio para la cobertura sanitaria marco adaptado del sistema sanitario, que se guía por los conceptos y universal. La reforma constitucional es una fuerza de movilización que las definiciones de la Organización Mundial de la Salud, para tener una permite obtener importantes avances en el cambio institucional del idea del alcance de las reformas sanitarias en los primeros 10 años de la sector sanitario, lo que fomenta dos aspectos de la viabilidad del cambio: constitución. En este contexto, se aplicó el marco para documentar las la aceptación de las partes interesadas y la autoridad para proceder.

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