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.
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Health professionals often undertake private work whilst also employed by government. Such dual practice (DP) is found in both high-income and lower- and middle-income countries (LMIC) around the world, with varying degrees of tolerance. This review focuses on DP in South and East Asia in the context of the rapidly expanding mixed health systems in this region. Although good data are lacking, health service uptake in South and East Asia is increasing, particularly in the private sector. Appropriately regulated, DP can improve health service access, the range of services offered and doctors' satisfaction. By contrast, weakly regulated DP can negatively affect public health service access, quality, efficiency and equity, as doctors often pursue the balance of public and private work that maximizes their income and other benefits. The environment for regulation of DP is changing rapidly, with improved communications opportunities, increasing literacy and rising civil society, particularly in this region. Currently, the options for regulating DP include (1) those which restrict the opportunities for dual practitioners to prioritize income and other benefits over their responsibility to the public; these require a level of regulatory capacity often missing in LMIC governments; and (2) those which not only tolerate public-sector doctors' private work but also encourage adequate health services for the general public. Growth of the private sector and weak regulation in South and East Asia increases the risk that dual practitioners will ignore the poor. Responsive and decentred regulation of doctors involving professional associations, civil society and other stakeholders is increasingly recommended. Moreover, as governments in LMIC strive for universal health coverage, market and financing opportunities for regulation of DP may arise, particularly involving insurers. This may also help to improve the current imbalance in the urban-rural distribution of doctors.
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