The private health care sector comprises hospitals, nursing homes, dispensaries / clinics, diagnostic facilities and laboratories. Going by the available data, it is seen that at the all-India and state levels, the private sector currently dominates both outpatient (OP) and inpatient (IP) care and is being used by a sizeable proportion of people, especially poor. Surprisingly, in India the private health sector has been allowed to grow in an undirected fashion with no laws to regulate the geographical distribution of providers, the types of technology to be made available, the way charges are levied or the prices themselves.
Because of this, patients have to face a host of problems like substandard diagnostic and treatment facilities, inadequate treatment, over- prescription by doctors, unnecessary investigations and interventions and consequently exorbitant charges, usage of unethical and irrational practices and lack of basic information relating to their health, wasting of scarce health resources, serious problems of medical malpractice and negligence. Despite this, the majority of people still choose to use the private health sector probably because of its accessibility in terms of distance and timing, private providers’ cleanliness and ambience. As a consequence, patients are compelled to avail of services from an unplanned, unregulated and unaccountable private sector. Regulation occurs when a government exerts control in the form of legal controls.
This involves setting the policy agenda, designing the legislation and implementing and enforcing its requirements. The state’s intervention in these forms of regulation will help to discourage perverse practices and ensure equity. However, for the last several decades the private health sector has resisted any move towards regulation and rejected outright the concept of minimum clinical standards. Now all stakeholders can heave a sigh of relief as the Kerala Clinical Establishments (Registration and Regulation )Bill 2017 is on the anvil and it is the first attempt to take the bull by the horn. And the crucial question raised by all stakeholders is whether the forthcoming clinical establishment Bill 2017 offers a strategy and action plan for building a stronger health system over the coming decade, one that is capable of delivering quality health care to all of us? Indeed, the objective of the Bill presents a promising picture wherein it says that the basic objective is itself improvement of public health by prescribing basic minimum standards for different categories of clinical establishments so as to ensure proper quality healthcare.
Bureaucrat at the top. Will it help?
Section 2 © (i) of the Bill defines the term clinical establishment. The term includes hospitals, maternity homes, nursing homes, dispensaries, clinics, sanatorium and institutions of similar facilities with or without beds that offer diagnosis, treatment or care for illness or injury or deformity, abnormality, dental care or pregnancy in any recognized system of medicine. Here, recognized system of medicine brings in allopathy, yoga, naturopathy, ayurveda, homoeopathy, siddha and unani, or any other system recognized by the government The Bill also in one sweep brings under its ambit all establishments owned, controlled or managed by the government, a department of the government, a trust (public or private), individual proprietorship, a partnership firm, corporation registered under a central, provincial or state Act (whether or not owned by the government), charitable society, a local authority and a single doctor. Any laboratory which offers pathological, bacteriological, genetic, radiological, chemical, biological and other diagnostic or investigative services is also brought under the regulatory umbrella.
The unique feature is that the Bill is applicable not only to the private sector but also to the entire health care delivery systems in Kerala both in the public and the private sector. However, the basic drawback of the Bill starts from this issue as it is not advisable to draft a single piece of legislation to regulate both the private as well as the public health care sectors. One has to recognize the brutal reality that both these sectors are very large and complex and hence using a single yardstick to regulate these systems will cause chaos and confusion. The proposed legislation envisages a pyramidal structure for the regulation. At the apex level or rather the state level, the Bill envisages the constitution of a state council for clinical establishments. It is a multi-member body comprising 16 members under the secretary to the government, health and family welfare department. Directors of health services, Indian system of medicine, homoeopathy, public health laboratory are all ex-officio members. The state council will draw representatives from professional bodies in the fields of modern medicine, dentistry, nursing, associations of the different systems of medicine, etc. and representatives from patient welfare organizations. One representative of Indian Medical Association Kerala unit and one representative of Ayurveda Medical Association are also present. The paradox is that apart from the Indian Medical Association Kerala unit, there is no other representation of the gigantic private health sector in India.
Another query that comes to the mind when one closely peruses the composition of the state council is that whether the proposed bureaucratic structure of the council controlled by the secretary to the government, health and family welfare department can do justice to the functions that have been entrusted upon. Moreover, the secretary is also in charge of state-run health facilities over which the Bill exercises jurisdiction. The question is not whether the state department of health will report its own lapses, but on the propriety of regulating and judging establishments including its own. The function of state council will be to determine within two years the minimum standards for ensuring proper health care by clinical establishments, develop classifications of these establishments and taking responsibility for periodic review and maintenance of a national register of clinical establishments.
A drawback that is noticed is that the Bill provides wide discretionary power to the state council to classify the clinical establishments into different categories and to fix a minimum standard to be undertaken by the establishments. Though it is mentioned that the council shall follow a consultative process for determining the standards and for classification of clinical establishment, no clarity as to what criterion to be followed is specified. At the same time inadequate representation of the private healthcare service providers in the council will definitely affect the working. Further perusal of the Bill makes it evident that the Bill is aimed at the classification of clinical establishments of different systems of medicine. This particular section will cause chaos because it is not that easy to identify and codify each clinical establishment working under all the systems of medicine.
As per the Bill, the government shall constitute a multi-member district registering authority in each district for registration of clinical establishments.
The district council is entrusted to a) grant, renew, suspend or cancel registration of a clinical establishment; to (b) enforce compliance of the provisions of the Act and the rules made there under; (c) cancel the registration of such clinical establishment where there is imminent danger to public health and the health and safety of patients and staff; (d) prepare and submit reports periodically of such nature as directed by the council; and (e) perform such other functions as may be prescribed. Registration will be granted to those clinical establishments which comply with the minimum conditions for registration as envisaged:
(a) The minimum standards according to the category of clinical establishment as may be notified by government.
(b) The minimum qualifications for the medical and paramedical staff as may be prescribed by government.
(c) Maintain standards of safety, infection control and standard treatment guidelines as may be notified by the government.
(d) Undertake to mandatorily comply with the orders issued by the council from time to time, in such form as may be prescribed.
(e) Undertake to furnish such information to the state government as notified.
(f) Display the registration certificate at a prominent place.
Here the representative of Indian Medical Association Kerala unit and one representative of Ayurveda Medical Association are conspicuously absent. The Bill is all set to ensure transparency, affordability and accessibility of health care services. But the prime question is does the Clinical Establishment Bill have the capacity to pounce on errors and maintain the quality of health care services rendered by the private hospitals and public hospitals? If quality issues are being compromised by these establishments, it calls for the re-evaluation of policy measures to redefine their role, growth and coverage, and to seek appropriate interventions to ensure that these institutions are more quality-focused and better able to meet the needs of their patients . To one’s dismay such an approach is lacking in the Bill.
Again the two major concerns unanswered are: who will assess quality and on what criteria? While quality care may be defined as the degree of excellence in overall care, the judgment of quality may depend on whose perspective is sought. The Bill should therefore take into account the antics employed by private hospitals ie., private hospitals have been known to reduce quality by reducing inputs, to disregard social pricing considerations or, worse, to try to increase their profits by providing services that are unnecessary or even harmful. Classification criteria must be carefully drafted. The starting point can always be classification on the basis of investment and high end facilities provided. To alleviate these problems, it is imperative that the quality competitive incentives may be introduced by the government. For example, some form of public dissemination of information must be envisaged to focus on the extent to which service quality standards are being met by the hospitals. Initially at least, the prominent hospitals (public and private) should be periodically evaluated. As the rating system evolves, other hospitals could be gradually included in the set. The rating responsibility should, realistically, be borne by some independent agency.
The rating must be let known to the people through information centres, public awareness campaigns, media participation and a variety of accessible and easy-to comprehend literature. When health care customers are able to make more informed choices based on the evaluations, it is likely to provoke those hospitals that earn a poor rating or ranking to improve service quality. Those hospitals that earn low ratings consistently should be targeted by regulatory agencies for appropriate action. The social incentives of being rated low should also serve to foster a competitive environment for better ratings among hospitals, especially when they are held up to public scrutiny. One should never forget that since private hospitals are not subsidized and depend on income from patients, they should be more motivated than public hospitals to provide quality services to patients to meet their needs more effectively and efficiently. By doing so, they will not only be able to build satisfied and loyal clients who will revisit the same facility for future needs; the patients will also serve as a source of referrals to recommend the private establishments to friends and family, thereby sustaining the long-term viability of private hospitals.
(Dr. Bismi Gopalakrishnan is Dean, Faculty of Law, Mahatma Gandhi University, Kottayam & Associate Professor and Head Department of Law, University of Kerala.)