The report of a recently concluded research project: “Mapping the regulatory architecture for health care provision in mixed health systems”, including case studies from two Indian states, is attached.


LMIC Mixed Health Systems: mixed health care systems in low and middle income countries are distinguished by significant heterogeneity in types of establishments and providers, a dominant unorganized private sector, and inefficiencies in government delivery of health services. Health care provision in these mixed systems is typified by high, often out-of-pocket, expenditures on health care by users, significant shortfalls in quality of available health care, frequent ethical digressions by health care providers and by wide variations and inequities in physical availability and accessibility to health care for users. These phenomena have negative significance for public health, health equity and health rights, and collectively impede progress towards the Millennium Development Goals. More effective regulatory policies and systems are necessitated in LMIC, to address these varied concerns around mixed health care provision.

Regulating Health Care in LMIC Mixed Health Systems: We review the existing literature on regulatory approaches in LMIC mixed health systems. In different LMI countries with mixed health systems, a combination of state-led and non-state mechanisms have been instituted to regulate different aspects of health care provision. These can be classified broadly as 1) Direct regulation – led by the state and enacted through the imposition of laws and bureaucratic structures and rules, 2) Market based approaches – incentivising providers to modify their behaviour to align with broader objectives, and 3) other approaches, including public-private partnership based schemes, contracting, and insurance. Each of these mechanisms have had limited success at scale, and regulation of health care provision remains one of the pre-eminent challenges for future health policy in LMIC. Yet, the specific institutional and systemic contexts for failures of regulatory policies in LMIC remain poorly explored, and represent a significant gap in the knowledge.

Policy Research Tool: The research tool proposed in this paper is designed to empirically map and characterize the prevailing regulatory architecture for health care provision in a particular geo-political unit (province or country). The tool combines the use of desk and field based methods and is founded on actor-centred frameworks of policy research including ‘empirical constitutionalism’ (Hjern and Hull 1982), and ‘backward mapping’ (Elmore 1982). Actual roles of state and non-state groups and organizations in enacting different aspects of health care regulation are elicited, and compared with the putative or expected architecture of regulation in the country / province. Consequently, gaps can be identified in the design and implementation of regulatory policies. The outputs of the research can be utilized to effect relevant modifications in the design of regulatory policies and institutions, to strengthen particularly aspects of implementation, and as a baseline against which to assess the success of regulatory reforms the country / province.

Pilot Studies: The research tool was applied to conduct pilot studies in two States in India, Madhya Pradesh and Delhi. The regulatory architecture for health care provision was mapped, and key design and implementation gaps identified in both States. In Madhya Pradesh, policy design gaps were most apparent for the domains of cost of care. Also key were the absence of a formal system for the control of quackery, of a community-based platform to address issues of grievances with care quality and conduct of providers, and of supportive or incentive-based approaches to improve provider distribution in rural areas. Major gaps in implementation included low coverage of policies for registering clinical establishments; and inefficiencies in implementing corrective procedures for erring establishments and medical professionals, and enforcing mandatory rural placements.

In Delhi State, design gaps identified included the absence of systematic approaches to regulate accessibility of care, and costs of care for non-EWS sections; and the absence of a formal mechanism to limit quackery, and of community-based platform to address issues of grievances with care quality and conduct of providers. Key implementation gaps included low coverage of schemes for social insurance and policies for registering clinical establishments; and inefficiencies in implementing disciplinary procedures for medical professionals and determining the locations of new hospitals.

Emerging underlying reasons for implementation gaps in both States included: 1) the pervasive influence of medical political interests (regulatory agencies are largely constituted of medical professionals, or reliant on their cooperation), 2) discordance in inter-departmental relationships and coordination within the State regulatory machinery, and 3) severe constraints in numbers and capacities of personnel for regulation.

Regulatory Architecture Report_Jun11.docx