From the locus of India’s health governance hub, revelations about the country’s regulatory structure and weaknesses

Editor's Note: India is a textbook case in how health markets are both problematic and a source for new ideas. More than 60% of all health spending in India is made by consumers, out-of-pocket. Quality of care—recounted vividly in this New Yorker about TB care in the country’s north—is wildly variable. Yet the marketplace has yielded more than 200 promising health market innovations in CHMI’s first year survey.

However, of CHMI-profiled health market innovations across India, just three are regulatory policies, compared with literally hundreds of delivery programs and efficiency-promoting IT enhancements.

Why are innovative, effective regulatory policies so hard to come by in India (as indeed, in much of the world)? We contacted a health policy expert in Delhi to learn how he views the regulatory environment in the country. Kabir Sheikh heads the Health Governance Hub, an interdisciplinary program of health policy research, capacity building and advocacy at the Public Health Foundation of India. At this week’s Health System Reform in Asia 2011 conference, Dr. Sheikh will present on findings from their recent research on health regulatory architecture.

Below, here is an excerpt from CHMI's interview with Dr. Sheikh. Enjoy!

CHMI: What are the challenges in dealing with the private health sector?

Kabir Sheikh: When it comes to the private health care sector in India, we see:

  1. Massive out-of-pocket spending by users of care, partially because of over-medicalization and profit-driven and collusive practices of health providers,
  2. Variable quality—especially with the large informal sector, and
  3. A massively skewed distribution of qualified providers towards the cities.

Apart from provider distribution, these challenges are often overlooked during the planning process. Health care is seen as intrinsically valuable, so quality, ethics and (until recently) spending problems have been seen as secondary concerns, once basic access is assured. But there are serious implications of these failures of health markets, for individual and public health, for social equity, and for the evolution of the medical and health fields.

CHMI: What states have adopted new regulatory structures to better steward the market?

KS: In the past decade or two, states including Orissa, Sikkim, and West Bengal have adopted Clinical Establishments Acts and Rules to ensure physical standards and norms in hospitals and clinics. Yet we can’t easily establish the efficacy of these Acts in actually curtailing inappropriate practices, or causing a shift towards wider coverage.

Partly, questions around the efficacy of these laws result from the fact that constituent reforms—setting up new structures and organizations—do not lend themself to measurable, attributable changes in the short term. Institution-building is social development, and can't be evaluated like a public health program. For example, if the acts don’t work ideally in the first instance, they are not replaceable with another alternative.

CHMI: Given the difficulty attributing improvements resulting out of health policy reforms, how do you propose they be evaluated?

KS: Regulatory institutions should be scrutinized, assessed and constantly improved, no doubt, but there should be a different set of yardsticks related not only to outcomes but to process—organizational efficiencies, social relevance, extent of participation of community, responsiveness and accountability.

CHMI: What regulations help? Is there such a thing as too much regulation?

KS: You can have too much regulation, an Orwellian exaggeration of rules and licensing requirements, but inadequate regulation is a far more serious concern in India than overregulation, particularly in health.

Regulation, like all other forms of institutional reform is deeply contextual—regulatory institutions are embedded in local society, culture, value systems and balances of power. So a community-based intervention that works in a Tamil Nadu village may not work in a city in Gujarat, or even in another Tamil Nadu village.

The question: 'what regulations help' is also premature, for an environment where there is no (or little) de facto regulation. Most of it is on paper, lacking teeth.

Regulation helps, if well governed and implemented. A functioning hospital grievance office can aid accountability, a well-enacted policy can redistribute precious human resources to rural areas, and providing quality low cost drugs in government pharmacies can cut unnecessary spending on private drugs.

All these approaches are also liable to fail. But we can't not attempt to regulate - the costs to human health and life are too great. We must continually monitor the mechanisms, and tailor them to local specificities. Successful regulation requires community support and social acceptance, and an understanding of field realities.

Amartya Sen in "The Idea of Justice" distinguishes the concepts of 'Niti' (justice as policies and rules) from 'Nyaya' (socially realized forms of justice). What we have in India is a preponderance of the former interpretation of justice—we have regulatory institutions with structures, rules and norms, but they are not always effective.

What we need is Niti (rules) and Nyaya (socially realized justice) approximating each other more closely. Regulation is, or at least should be, fundamentally linked to justice, equity and social protection—for individuals as well as disadvantaged or disenfranchised communities, citizens, taxpayers, and also health providers.

CHMI: Describe a regulation from your case studies.

KS: To identify gaps in policy design and implementation, we mapped the regulatory architecture for health care provision in two Indian states.

Our study revealed:

  • Deficiencies in how regulatory policies are designed, in areas like cost containment, quality, provider conduct, and care availability, and
  • Gaps in implementing existing policies.

One case study revolves around land subsidy policies for private hospitals, offered on the condition that they provide some of their services free to poor patients. Most hospitals flout this rule. A government department was mandated to enforce the policy, but staff were diverted in other tasks, and also lacked enforcement capacity.

It is difficult for organizations with both developmental and regulatory functions to do justice to the latter, since the latter is an unpopular role and the former entails them in complex relationships of co-dependency with those they are expected to regulate. The two functions must be separated.

CHMI: How will the Indian health care system look in 15 years?

KS: Although 15 years is a very short time in the lifespan of a huge democracy, I am optimistic about the future of India's health systems. There is an emerging critical consciousness about health systems in the polity and the laity. Indian health systems will be more accountable to these broader forces, and less controlled by a few interested groups, but not without a fight.

View the report on health regulatory architecture co-authored by Kabir Sheikh here.