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Regulatory Policies for Urban Health
By Prasanna Saligram
Regulation in Health Sector
With the private markets becoming significant, regulation of health services has gained importance
(Bloom et. al. 2009). The definition of regulation in the narrowest sense comprises of statutory
action to constrain market entrepreneurship (Maynard, 1982) but in a broader sense encompasses
all mechanisms both by state and non-state actors that seek to modify the individual and
organizational activity in the health sector (Saltman et al 2002). The objectives of Regulation are two
fold - one to correct for market failures (Bloom et. al. 2009) through health sector management
mechanisms like regulation of quality; efficiency; provider behaviour; payers and regulation of
pharmaceuticals; prevention of quality skimping (Saltman et. al. 2002) and two to promote social
and economic policy objectives like equity and justice; health and safety; patients’ rights and
entitlements and public disclosure for informed citizens (Saltman et. al. 2002). Regulatory
instruments for the domain of provision of health services are directed towards High costs of care;
better quality of care; ethical conduct of providers and equal availability of health care (Roberts et.
al. 2004)
Indian Health System and Regulatory scenario
Indian health system is a mixed health system where the public health systems are weak and under-
resourced (Nandkumar et al 2004) and the private sector is very heterogeneous and exploitative
(Sheikh K et al 2010). Both the public and private operate in a weakly regulated environment (Peters
and Muraleedharan 2008). The boundaries between the public and private providers are also
blurred (Mills and Brugha 2002). This results in unethical, irrational practices sometimes leading to
outright criminal negligence. A recent study on the regulatory architecture in two states of Madhya
Pradesh and Delhi revealed significant gaps in the policy designs for regulation for each of the
domains. On the costs of care there were no established price schedules or reference prices defined
for treatments and procedures and absence of anti-trust laws for restriction of unrestricted profit
mongering (Sheikh K et. al. 2013). On the regulation of quality of care and provider conduct huge
gaps exist in the design of regulatory architecture like the absence of standard treatment guidelines;
lack of practice of evidence based medicine and health care users’ survey; the government was not
bringing its power, as a high volume purchaser, to bear by enforcing performance based incentives;
self regulation measures like accreditation is in its infancy and largely inadequate and other
mechanisms like benchmarking, peer review, performance indicators, public disclosure, triple loop
learning are non-existent; enforced self-regulation measures like, making accreditation as a pre-
condition for empanelment for government schemes, is largely absent (Saligram PS et. al. 2013 in
press). Even where policies exist, there are lacunae in implementation. Implementation is hampered
by inadequate financing and staff capacities; lack of separation between the regulatory activities and
the developmental activities of the public sector resulting in former getting less autonomy and
attention; frequent contestation by the professional bodies (Sheikh K et. al. 2013). The urban health
scenario is further complicated by the presence of multiple agencies like the municipal and urban
local bodies responsible for the health of the urban populations. Most of the ULBs suffer from funds
scarcity and there are not enough incentives to implement regulations for better public health (Das
Gupta M et. al. 2009).
Proposed Regulatory Architecture for Urban services
Design
As mentioned in the previous sections there are serious gaps in the design of regulatory policies in
the country. The following is the architecture that could be proposed to regulate the costs, quality,
conduct and distribution of providers. Since no one regulatory approach would work, there has to be
a combination of approaches. Braithwaite and colleagues (2005) advocate for a Responsive
regulation Pyramid in which the approaches are arranged in a hierarchical order from the voluntary
to the command-and-control approaches as shown in Table 1 striking a balance between the
compliance and adherence. As can be seen from the table considerable gaps exist in the regulatory
policies at each level and for each domain of health services. These regulatory instruments have to
be put in place to shore up the regulatory scenario as a prerequisite to ensuring efficient and quality
services under the proposed National Urban Health Mission.
Implementation
In addition to the deficiencies in the design architecture, the regulatory scenario is also plagued by
the lacunae in the implementation of the policies. This section presents the institutional mechanisms
needed for the implementation of regulatory policies. The following are some of the principles on
which the regulation has to be located.
The regulatory agency shall be an autonomous agency with suitable checks and balances
The regulatory agency shall be separated from the health directorate but having health
directorate’s representation in order that there is no conflation between the developmental
and regulatory functions.
The Regulatory agency shall be responsible for ensuring standards of both the public and
private facilities.
The regulatory agency shall be strengthened with substantial funds, dedicated staff and
infrastructure both for its routine functions and also for such items as capacity building and
standards setting.
The whole regulatory architecture shall be centred around the issue of patients’ rights and
entitlements.
Convergence of the various agencies responsible for the delivery of health services in urban
areas. This means that the facilitation and monitoring of the other agencies like sanitary and
food safety departments which shall have close connections for the health of the urban
populations (Das Gupta M et. al. 2009)
The process of regulation could be a potential for harassment, corruption and red tape
coupled with the slow judiciary existing in the nation. Hence it becomes very important that
reasonable standards with the involvement of all stakeholders are set; information
disseminated; facilitating compliance and minimizing the scope for corruption (Das Gupta M
et. al. 2009). The setting of standards shall also take into account the diversity existing
among the providers and accordingly modulated else it might lead to a situation where
some of the small time rational providers (who might be the only access to the people)
might be crowded out.
Figure 1 provides a draft outline of the sort of regulatory mechanism that could be put in place.
References
Braithwaite, J., Healy, J., Dwan, K., (2005). ‘The Governance of Health Safety and Quality’. Commonwealth
of Australia, 2005
Das Gupta M et. al. (2009). ‘How might India’s Public Health Systems be strengthened?’, Policy Research Working Paper, No. 5140, World Bank, Washington DC. Grol, R(2001). ‘Improving the quality of medical care’. JAMA,Vol 286, No 20, November 2001 pp 2578-2585 Jost, TS (1988). ‘Necessary and proper role of Regulation to assure the quality of health care’. Hein Online,
25 Hous. L. Rev. 525 1988.
Maynard, A. (1982). The Regulation of Public and Private Health Care Markets. A Public/Private Mix for Health: the Relevance and Effects of Change. London. Mills, A & Brugha, R (2002), 'What can be done about the private health sector in low-income countries?', Bulletin of the World Health Organization, 80, 01: 325-330 Ministry of Health and Family Welfare (2013). National Urban Health Mission, Framework for Implementation. New Delhi. 2013 Nandakumar, A. K., Bhawalkar, M., Tien, M., Ramos, R., & De, S. (2004). Synthesis of Findings from NHA Studies in Countries.Health (San Francisco). Nishtar, S (2010).’The mixed health systems syndrome’. Bulletin of the World Health Organization. 88(1):
74-75
Peters, D.H. & Muraleedharan, V.R., 2008. Regulating India's health services: to what end? What future? Social Science & Medicine (1982), 66(10), 2133-44.
Roberts, M Hsiao, W Berman, P & Reich, M (2004). ‘Getting Health Reform Right’.Oxford University Press.
New York
Saligram, PS Sheikh, K & Hort, K (2013). Weak at the top and the bottom: Applying the responsive
regulation pyramid to assess quality of care regulations in India
Saltman RB, Busse R, Mossalios E (eds). ‘Regulating entrepreneurial behaviour in European health care
systems’. European Observatory on Health Care Systems. Open University Press available online at
www.euro.who.int/__data/assets/pdf_file/0006/98430/E74487.pdf accessed on 23.04.2013
Scrivens E (2002). Accreditation and regulation of quality in health services. Chapter 4 in Saltman RB,
Busse R, Mossalios E (eds). ‘Regulating entrepreneurial behaviour in European health care systems’.
European Observatory on Health Care Systems. Open University Press available online at
www.euro.who.int/__data/assets/pdf_file/0006/98430/E74487.pdf accessed on 23.04.2013
Sheikh, K Saligram, PS & Prasad, LE (2013). ‘Mapping the regulatory architecture for Health Care Delivery
in LMIC Mixed Health Systems’. Working paper series, Nossal Institute for Global Health, Health Policy and
Health Finance Knowledge Hub, No. 26, pp1-28, April 2013
Table 1: The Regulatory instruments for the Health sector
Regulatory level
Domain of Regulation
Text book approaches to regulation Policies Availability in India
Voluntary
Costs of Care Display the schedule of charges Not followed uniformly, available in Karnataka1
Quality of Care Continuing Medical Education (CME)2 CME organized in a limited way by the Indian Medical Association
Clinical Guidelines2 Standard Treatment Guidelines for some specific treatments by National Rural Health Mission3
Evidence Based Medicine2 Absent Health care users’ survey4 Absent
Conduct of providers Open disclosure4 Absent
Accessibility of care Patients’ charter Not present uniformly across the country
Market Mechanisms
Costs of Care Anti-trust laws Absent
Prevention of unbridled profit mongering Absent Quality of Care Performance based incentives5 Largely absent
Purchasing arrangements5 Purchasing arrangements under the Public-private partnership rubric (PPP). Some Human Resource and staffing conditionalities for empanelment of the private providers
Conduct of Providers Provider Payment Mechanisms5 Largely on Fee-for-service basis.
Contract Management6 Absent
Accessibility of care Permission for new hospitals based on need and after due inspections
Not followed uniformly. Delhi state has this7
Self Regulation
Costs of care -- --
Quality of Care Accreditation8 Accreditation on a voluntary basis
1 Karnataka Private Medical Establishments Act, 2009
2 Grol 2011
3 Ministry of Health and Family Welfare, 2005
4 Braithwaite et. al. 2005
5 Jost 1998
6 High Level Expert Group (HLEG) 2011
7 Government of Delhi, Directorate of health and family welfare, Hospital Cell
8 Scrivens 2002
Benchmarking5 Absent
Peer review5 Absent
Performance indicators5 Absent
Triple loop learning4 Absent Conduct of providers Ethical Guidelines Ethical guidelines evolved by the Medical Councils as a form of
peer regulation. Accessibility of care Public disclosure4 Absent
Meta Regulation
Costs of Care Setting of prices for treatments Largely absent
Price schedules Largely absent
Quality of Care Enforced self-regulation4. Eg. Accredited facility for government schemes.
Absent
Enforced quality improvement4. Eg. Renewal of License on CME credits
Absent
Prescription Audits4 Absent
Conduct of Providers Medical Audits4 Absent
Accessibility of Care Patient Grievance Redressal Mechanisms with Ombudsperson4
Absent
Community based Monitoring and Planning of health services
Communitization component of the National Rural Health Mission
Command and Control
Costs of Care Revocation of license for failure of disclosure of prices4 Absent
Quality of Care Licensing of practitioners Licensing of practitioners through the medical councils9
Licensing of Facilities Clinical Establishment Act and state level acts in limited states10
Conduct of Providers Consumer laws Consumer Protection Act for Medical Negligence Accessibility of Care Public Health Acts Largely absent, but present in 2 states of Tamil Nadu11 and
Assam12 9 Indian Medical Council Act, 1947 and other council acts
10 Clinical Establishments Act, 2010 and state acts
11 Tamil Nadu Public Health Act, 1939
12 Ministry of Health and Family Welfare, Government of Assam, (2010). 'Assam Public Health Act'.
MINISTRY OF HEALTH AND
FAMILY WELFARE
DIRECTORATE OF HEALTH AND
FAMILY WELFARE
REGULATORY AUTHORITY
PATIENTS’ EMPOWERMENT
Public Health Act
Patients’ rights and entitlements
Health Services Charter / Patients’
charter
Grievance Redressal Mechanism
Ombudsperson
Mahila Arogya Samitis / Rogi Kalyan
Samitis1
Ward Action for Health (Ward planning
and Monitoring)
Report Cards
Public disclosure about clinical facilities
QUALITY ASSURANCE TEAM1
Setting of standards periodically
Accreditation of both private and
public facilities
CME, EBM, STG etc.,
IPHS Standards setting for urban
facilities
Clinical Establishments Act
Enforced Self Regulatory policies
Medical and Prescription Audits
1. NUHM Framework document
MINISTRY OF HEALTH AND
FAMILY WELFARE
DIRECTORATE OF HEALTH AND
FAMILY WELFARE
REGULATORY AUTHORITY
PROJECT MANAGEMENT UNIT
Contract Management
Monitoring and Evaluation
HMIS
Empanelment of providers
based on predetermined
criteria
Provider Payment Mechanisms
Performance based incentives
Negotiation and setting of
price lists
Monitoring of the price lists
Monitoring of other agencies’
work like sanitation and food
HEALTH PERSONNEL
REGULATION
Education
Registration and
licensing
Deregistration and
sanctions
Renewals of
registrations