What explains regulatory failure? Analysing the architecture of health care regulation in two Indian states

Abstract

Regulating health care is a pre-eminent policy challenge in many low- and middle-income countries (LMIC), particularly those with a strong private health sector. Yet, the regulatory approaches instituted in these countries have often been reported to be ineffective-India being exemplary. There is limited empirical research on the architecture and processes of health care regulation in LMIC that would explain these regulatory failures. We undertook a research study in two Indian states, with the aims of (1) mapping the organizations engaged with, and the written policies focused on health care regulation, (2) identifying gaps in the design and implementation of policies for health care regulation and (3) investigating underlying reasons for the identified gaps. We adopted a stepped research approach and applied a framework of basic regulatory functions for health care, to assess prevailing gaps in policy design and implementation. Qualitative research methods were employed including in-depth interviews with 32 representatives of regulatory organizations and document review. Several gaps in policy design were observed across both states, with a number of basic regulatory functions not underwritten in law, nor assigned to a regulatory organization to enact. In some instances the contents of regulatory policies had been weakened or diluted, rendering them less effective. Implementation gaps were also extensively reported in both states. Regulatory gaps were underpinned by human resource constraints, ambivalence in the roles of regulatory organizations, ineffective co-ordination between regulatory groups and extensive contestation of regulatory policies by private stakeholders. The findings are instructive that prevailing arrangements for health care regulation are ill equipped to enact several basic functions, and further that the performance of regulatory organizations is subject to pressures and distortions similar to those characterizing the wider health system. This suggests that attempts to strengthen health care regulation will be ineffectual unless underlying governance failures are addressed.

Private sector opportunities and threats to achieving malaria elimination in the Greater Mekong Subregion: results from malaria outlet surveys in Cambodia, the Lao PDR, Myanmar, and Thailand

“…This may reflect continued patient demand for case management services across different outlet types as well as motivation among unauthorized providers to provide services to meet the demand. This may also reflect inadequate capacity of inspection and judiciary agencies, and a lack of resources to implement routine inspections as evidenced by other research [21, 22]. A review by Montagu and Goodman regarding the regulation of the private sector in developing countries has shown that regulatory approaches face persistent challenges [23].…”

Health systems in India

“…6 However, most of the private health-care providers are concentrated in urban India, providing secondary and tertiary care health-care services. The public health-care infrastructure in rural areas has been developed as a three-tier system based on the population norms and described below.…”

Regulating the for‐profit private healthcare providers towards universal health coverage: A qualitative study of legal and organizational framework in Mongolia

“…As emphasized by the GVG Consultancy Team, “Government entities deal separately with parts and parcels of the same subject contributing to lack of transparency and accountability, and in the case of a problem, no one is responsible.” Both legal and accountability issues have affected the effective implementation of regulations in Mongolia, along with the lack of technical and financial capacity and corruption. These are challenges shared by many other LMICs …”

“…These are challenges shared by many other LMICs. 17,19,[29][30][31][32] In governance, the dominance of the state in health regulation-as in Mongolia-is being increasingly criticized, as no single actor possesses the full range of knowledge required to solve such complex problems arising in such a pluralistic and complex health systems. 10,22,29,33 The disciplinary role of professional organizations, the empowerment of patients, the safeguarding of their rights to redress, and the increased involvement of civil society in designing and implementing health regulations are critical to advance governance in health regulations.…”