Legal and institutional foundations for universal health coverage, Kenya

Abstract Kenya’s Constitution 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
The constitution of a country is its supreme law, which underpins all other laws as well as citizens' pursuit of peace, justice and human development. 1 Explicit constitutional provisions on the right to health exist in 28 of 47 Member States of the World Health Organization (WHO) African Region. 1 Yet there is limited knowledge about country experiences with constitutionally mandated health reforms, particularly in low-and middle-income countries.
Kenya's 2010 Constitution 2 replaced the constitution adopted when the country gained independence in 1963, creating new normative, structural, institutional, policy and administrative standards. The 2010 Constitution provides important opportunities for fundamental reform, through key reform agents such as independent commissions and a restructured judiciary and parliament, among other core institutions, agencies and organs in government. 3 A key constitutional standard requires the state to take policy, legislative and other measures to fulfil its obligations in respect of health. Consequently, in 2010 the Government of Kenya embarked on a reform of health policies, legislation and institutions. The health reforms are complex, with several multistakeholder processes running concurrently, developing various laws and detailing the formation or restructuring of various bodies. The reforms resonate with the United Nations high-level declaration on universal health coverage (UHC), which includes a commitment to strengthen legislative and regulatory frameworks for UHC. 4 In this respect, measuring change in Kenya's health reforms would contribute knowledge to advance UHC.
On the 10th anniversary of the constitution, we describe our efforts to review the status of these health reforms. The Health Systems Governance Collaborative, 5 in efforts to simplify governance to improve its understanding and applicability, has outlined a three-level approach for assessing the different elements and levels of governance: structural, process and outcome. Our paper focuses on structural measures, specifically the national laws and governance entities -the public implementing organizations and formal groupings across the entire health system. The aim of this article is to demonstrate an approach to measurement of health-system structure, and to apply that approach to analyse gaps and generate evidence for action to strengthen the structural capabilities in the Kenya health system.
In the following sections we first outline our theoretical framework on structural reforms in health systems. We then describe the background to Kenya's health-system reforms and the adapted health-system framework that we developed to analyse the multi-institutional reforms. Finally, we present our analysis and lessons learnt.

Theoretical framework
There is considerable evidence associating the constitutional right to health with better health outcomes. 6,7 A significant association has been found between a right to health in a national constitution and reductions in infant and under-five mortality rates. 6 Other researchers found that institutional environments shaped by a right to health encourage more and better delivery of health services and can partly account for a positive impact on health outcomes. 7 In this section we highlight some key linkages across health rights, health law, health institutions and health outcomes.
The rule of law is increasingly recognized as a determinant of health, and pivotal to health and development. WHO has observed that most public health challenges have a legal component and that the concept of public health law "includes the legal powers that are necessary for the State to discharge its obligation to realize the right to health for all members of the population. " 8 Further, it has been argued that the rule of law is a largely unacknowledged prerequisite for a wellfunctioning health system. 9 The law can translate vision into action on sustainable development, strengthen the governance of national and global health institutions and implement fair, evidence-based health interventions. 10 The law can be an effective tool to harmonize the mandates of public agencies, clarify functions and promote multiagency cooperation; to designate the responsible agency to resolve a particular issue; and to create new entities to coordinate activities across multiple agencies. 10 WHO notes that countries that have achieved UHC have built it on legal foundations, underscoring that developing and implementing a legal environment conducive to UHC is a critical investment. 11 WHO highlights three critical elements to assess country contexts on whether UHC law reform is feasible: (i) whether there is acceptance of (or opposition to) the proposed reform; (ii) whether there is authority to proceed (especially authority from political decision-makers); and (iii) whether the country has the ability to complete the work (the capacity to make, implement and administer laws). 12 Using the context of Kenya, we aim to demonstrate the extent of feasibility of UHC law reform, and to contribute lessons on the systematic assessment of legal and regulatory frameworks for UHC.
Effective health reforms should include reforming and restructuring the institutions through which health policies are implemented. 13 One author has described institutions as the rules of the game -the formal and informal rules and norms that structure citizens' rights, entitlements, opportunities and voices. 14 A distinction can be drawn between organizations and institutions. Organizations (public or private) are created to perform defined functions. Organizations are primarily the agent for institutional change with the emphasis on the interaction between the rules of the game (institutions) and the players of the game (organizations). 14 Formal institutions, the focus of this article, include the written constitution, laws, policies, rights and regulations enforced by official authorities (public organizations or agencies). 15 An analysis of institutional change includes considering whether a particular function is necessary or not (for example, the need for an agency or new patterns of service delivery by organizations). Organizational change, however, focuses on internal capacities (for example, automation of business processes or upgrading equipment). 16 Institutional change analysis must be driven by a focus on desired outcomes: in the case of health, multiple outcomes relating to UHC. Appropriate approaches and tools are needed to analyse and diagnose gaps and to predict further institutional change to strengthen the health system for UHC. 16 We describe an approach to analyse concurrent change to multiple health laws and public organizations.
We also consider social science theories related to advocacy and policy change efforts. 17 Among these, the largeleaps theory posits that "when conditions are right, change can happen in sudden, large bursts that represent a significant departure from the past, as opposed to small incremental changes over time that usually do not reflect a radical change from the status quo." 17 In Kenya, the 2010 Constitution created a major shift in feasibility for health law reforms, which triggered large changes in policies, laws, institutional and regulatory frameworks. In Fig. 1, we illustrate a theoretical connection between constitutional standards and long-term health-system goals, via analysing institutional change, optimizing the interconnected health outcomes, and rationalizing their assignment to health actors (public and private).

Background to reforms
The key aspects of Kenya's 2010 Constitution in relation to health were twofold: devolution of power to 47 county governments; and explicit provisions on the right to health. The extent of devolution of administrative functions varies across sectors. The health functions are extensively devolved: the national government is assigned health policy, national referral services and capacity-building for counties; county governments are assigned person-based and public health services within their jurisdictions. [18][19][20] The constitution prescribed mechanisms and timelines for implementation of the various constitutional changes, including a time-limited independent body to oversee the transition to devolved government. This process entailed the development of enabling legislation and institutions for devolution, including intergovernmental relations, applicable to all sectors. The constitution triggered a large number of public-sector reforms and energized political commitment to reforms, including initiatives to streamline the governance of public agencies in all sectors, and to prioritize government investments and reforms in UHC, agriculture and nutrition, housing and manufacturing. 21,22 To guide the transformation in the health sector, the Kenya Health Policy (2012-2030) was formulated 23 with policy priorities structured around WHO's six key components of a wellfunctioning health system: (i) leadership and governance; (ii) service delivery; (iii) health system financing; (iv) health workforce; (v) medical products, vaccines and technologies; and (vi) health information systems. [24][25][26] This six-component structure was adapted for Kenya by highlighting additional policy issues and areas for investment. The policy proposed to overhaul the health legal framework by installing a new general health law and specific laws to restructure each component. This comprehensive legal framework incorporated health infrastructure as a seventh component (Fig. 2). After the county governments were elected in 2013, the health policy was validated and updated to the Kenya Health Policy (2014-2030), 27

Conceptual and analytical framework
A major challenge in analysing the multiinstitutional change in Kenya was the lack of a uniform and coherent approach. The use of simplistic tools to analyse complex health systems often contributes to interventions that upset the equilibrium of the system, which can lead to policy resistance from stakeholders. 30 To align the health sector with the 2010 constitutional standards, Kenya's health policy prescribed specific laws to transform multiple parts of the system, but lacked detail on the overall structural design, offering no rationale on the configuration of health functions or the implementing organizations envisioned to optimize health outcomes across the devolved system. Therefore, to analyse what has changed since 2010, we deconstructed the health legal (and institutional) frame-work, component-by-component and function-by-function, guided by WHO concepts and definitions. WHO describes a health system as a set of interconnected parts that have to function together to be effective, consisting of all the organizations, institutions, resources and people whose primary purpose is to improve health. 31,32 The WHO framework for health-systems performance assessment identifies four basic health-system functions through which health investments flow: (i) stewardship; (ii) resource generation; (iii) service provision; and (iv) financing. In this respect, a health system would be considered well performing when all the relevant organizations, institutions, resources and people are functioning together and contributing optimally to attaining three intrinsic goals or outcomes: health; responsiveness; and fair financial contribution. 33 Consequently, health institutional reforms would be expected to optimize institutional capabilities to achieve the intrinsic health outcomes by transforming health functions component-bycomponent.
We developed an approach -the adapted health-system frameworkwhich enables a structured, all-inclusive framing of health functions, and promotes uniform and coherent analysis to identify structural gaps across the health system. We superimposed the core eight components of the Kenya Health Policy 2014-2030 and the four basic healthsystem functions described above. In this way, we created a grid with each cell representing a distinct health function. Our framework allows structure and function to converge, giving a perspective of the health system's foundational elements and acting as a tool to visualize change. We used the framework to systematically document the national health laws and public bodies (those already enacted and those in progress) to assess the extent of change, diagnose gaps and identify corrective adjustments. Hence, this article is not concerned with monitoring constitutional implementation, 34,35 or assessing whether specific health-system functions or accountability mechanisms are achieving desired outcomes (such as access to medicines 36 or immunization coverage 37 ).

Constitutional standards
Normative, structural, institutional, policy and administrative standards (e.g. bill of rights, state obligations, governance) International instruments (recognized by the constitution as part of national law) Accountability agencies (e.g. constitutional commissions, auditor-general, revenue authority, anti-corruption agency)

Rules of the game (institutional change: envision, analyse, predict, act)
Review, rationalize, delineate and enact (in national law) health functions and outcomes Define clear roles within health functions for public sector, non-state actors (private, nongovernamental organization, faith-based) Enact explicit and comprehensive rules and accountabilty relationships for health activities and actors

Immediate goals
The full scope of interconnected health outcomes (results) are defined across all health-system building blocks Each health outcome is assigned (in legislation) to the appropriate institutions(s) or organization(s) Laws, standards and regulations that underpin good governance

Long-term goals
Healthy people (individuals, households and communities) Responsiveness (of duty-bearers to the concerns of the poor, and the voice of right-holders) Fair financial contribution (equity, and financial risk protection)

Health investments optimized
Health resources aligned to assigned health results (functions)

Constitutional standards
Health institutional transformation (policy, legislative and regulatory changes) Preconditions (comprehensive health outcomes)

Health system performance goals (attainment of health outcomes)
Constitutional reforms in Kenya Regina Mbindyo et al.
Other authors have observed that stewardship is usually the most neglected function within health systems, yet it "anchors health to the wider society, comprising three broad tasks: providing vision and direction, collecting and using intelligence, and exerting influence through regulation and other means. " 38 The sub-function of regulation has been discussed when describing the complex health-care regulatory system in the United States of America. Seven distinct areas of regulatory focus were identified, 39 all addressing three competing health outcomes (access, quality and costs). These seven regulatory spheres are essentially a subset of our adapted framework since they relate to WHO's concept of health stewardship, and they align with WHO's six core healthsystem components. The spheres exclude health leadership (responsible for overall stewardship), and the other five components are subdivided and expanded to distinguish the perspectives relating to health regulation. Thus, health business relationships, public health and health research are distinct regulatory components. Our discussion will therefore highlight two stewardship sub-functions: overall system design and regulation.

Assessment methods
We obtained empirical evidence for this assessment from two primary sources. First, all the authors were closely involved in the health reform processes in various capacities, either as government planning experts or as technical advisors, engaging through the technical working groups and advisory panels. Second, we analysed various documents including national policies, legislative instruments (laws, executive orders, legal notices and legislative bills). We identified all the instruments enacted for purposes relating to health, as published in the official Kenyan Government website. 40 We then compiled a chronological list of these legislative instruments from 1921 to June 2020. For each instrument listed, we reviewed the legal text and identified two attributes: public body created and health function assigned. We then mapped all the bodies onto the adapted framework according to assigned function to see which governing entities and implementing organizations are in place and functional. We created two profiles: pre-constitution and postconstitution. Similarly, we mapped the initiatives that were in progress by June 2020 (technical working groups, advisory panels or parliamentary bills). To assess the extent of change in the regulatory sub-functions, we also extracted the data on the regulatory bodies formed to date (enacted and in-progress) and mapped these onto the seven regulatory spheres. 39

Legal and institutional changes
Before the 2010 Constitution, Kenya's health system was managed centrally by two health ministries and governed through the Public Health Act of 1921 and other statutes governing specific functions. A total of 28 public bodies existed (in the statutes), although three of these were not currently operating, and we could not ascertain whether they had ever been constituted ( Table 1). Shortcomings of the pre-constitution health structures were that institutional change was largely aligned to vertical public health programmes or to health professions. In particular, health professional bodies regulated most aspects of health in a cadre-centric model, creating a disproportionate focus on professional practice, with virtually no balancing  laws or independent authorities to safeguard consumer interests (such as safety, pricing and confidentiality).
In the period since the 2010 Constitution was adopted there has been a large increase in the number of health bodies. This transformation has included enactment of eight laws and creation of 65 new bodies (16 national, two intergovernmental and 47 county health departments). Seven additional reforms were in progress by June 2020 (Table 2).
Of the new laws, the Health Act, 2017 was the first major post-independence health legislation, delineating multiple health functions at the national, intergovernmental and county levels, establishing new bodies and mandating others to be enacted. The Act signalled a fundamental shift towards cadre-neutral health stewardship bodies (professions, products and institutions) and a greater focus on consumer aspects within health functions. These multiple reform initiatives demonstrate significant feasibility for health reforms. By prioritizing UHC reforms, political decision-makers have signalled authority to proceed, and broad acceptance by stakeholders. The multiple stakeholder engagement mechanisms led by the health ministry (technical working groups and advisory panels) enable the articulation of specific reforms within functions, facilitate consensus-building and isolate contentious issues to be resolved. Parliament is actively (but independently) engaged, including sponsoring bills in some priority areas (blood services, food and drug regulation), which creates pressure 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 arrangements 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 stewards (the national health ministry) and delineated stewardship sub-functions across the devolved system. Of the 65 new bodies created, 59 have stewardship mandates (the other six are concerned 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 system capabilities in providing vision Core components  and direction, collecting and using intelligence, and exerting influence, all contributing to the achievement of desired health outcomes. The seven distinct regulatory components are at varying stages of transformation (Table 3). Two new regulators have been formed (concerning health professionals and health research); two new regulators are mandated to be formed (for drugs and devices, and health-care institutions); three initiatives are in progress (concerning public health, financing arrangements and business relationships). However, two regulatory areas remain fragmented (public health and health-care professionals). For professions, five new cadrecentric bodies were created, resulting in a total number of 12 bodies (Table 2).  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 all sectors. In the health sector, all the 12 cadre-centric boards and councils fall into this category, but the 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.

Constitutional reforms in Kenya
Regina Mbindyo et al.
Overall, our analysis revealed structural gaps or inconsistencies across many health functions. We noted that, when the new laws and bodies were created, all the pre-constitution laws and bodies (including non-operational bodies) remained unchanged. Except for two merged health ministries, and minor amendments to other laws, these pre-existing structures were not eliminated or consolidated. The inherent fragmentation has therefore become entrenched in the system, with the attendant inefficiencies (gaps, duplication, overlaps and conflicts of mandates). A corrective action is therefore needed to rationalize and consolidate health functions, especially the regulation of public health and health-care professionals.

Conclusion and lessons learnt
Our approach has enabled us to measure institutional change, diagnose gaps and generate evidence for predicting further change across the entire health system of Kenya. Overall, the multiple gaps identified across the health-system components demonstrate the multiple opportunities to streamline health functions across the system. To identify strategic options for further institutional change, a systematic review of the evidence is needed, function-by-function, focused on defined outcomes. However, because a national health system is one system with multiple interconnected parts, any predictions about change in one function require a holistic vision of the overall design of the health system, describing each distinct element, and how the various parts should operate together. By mapping backward from the overall health system goals, we need to define the desired outcomes relating to the distinct health functions, then identify actions that are needed to optimize these outcomes across the interconnected parts of the health system.
We believe our adapted healthsystem framework is a useful tool for countries needing an all-inclusive framing of health-system structural elements to envision the overall design (future), analyse gaps (current) and predict the needed institutional change. In this respect, the grid is a versatile tool, to create context-specific frameworks, according to the health system attribute(s) mapped onto the cells (laws, bodies, gaps, outcomes). The various mappings can create multiple platforms for engagement, facilitating a holistic approach to health reforms.
The framework could be a useful tool for countries wishing to develop and implement a conducive legal environment for UHC. We have been able to quantify the extent of institutional change in Kenya's health system and to diagnose gaps for corrective action to strengthen health functions, but we did not focus on the effects or impact of these changes. We encourage further studies to assess the adequacy of laws enacted and the capabilities or actual performance of the bodies created. We have learnt that a national constitutional reform is a mobilizing force for large-leaps institutional change in health, boosting two aspects of feasibility of conducting health reforms for UHC: acceptance by stakeholders; and authority to proceed from political decisionmakers. 12 The third aspect of feasibility -capability -requires capacity enhancement and interdisciplinary collaboration (health, legal and human rights), which promotes mutual learning and uniformity of actions. Priorities for capacity enhancement include technical framing of reform issues and formulating health law that is compliant with UHC. Implementing health institutional change requires a holistic, big-picture perspective, envisioning the overall health-system design as it should be, including the spatial arrangement of health functions and the corresponding outcomes. It is then possible to systematically analyse the structural elements to diagnose gaps and to predict change. ■