The Clinical Establishments (Registration and Regulation Bill), 2007 is one of the important bills pending before the house that has somehow escaped the scrutiny of its more controversial counterpart-in-passage, the Broadcasting Bill. It may however have equally prominent implications for healthcare across the country. It has been introduced in parliament and is currently pending passage.
The bill notes in the introduction that healthcare in India is of uneven and uncertain quality, its supervision poor and there are few incentives in the current healthcare delivery system conducive providing enough incentives for improvement in efficiency. It also states that concerns voiced by the general public as well as a number of stakeholders coupled with the general perception of an inadequate regulatory framework is sought to be addressed by central legislation to create a uniform standard of facilities and services across the states. The highlights, provisions of the bill and relevant government documents can all be accessed from the PRS website (I thank Mr. Venkatesan for sending me the brief). The highlights of the provisions are as indicated below:

• As the name suggests, it seeks to register and regulate, and set standards for clinical establishments. It shall be applicable to all union territories and four states. Other states may adopt the Bill.
• A clinical establishment is defined as a hospital, maternity home, nursing home and any similar facility with beds. The definition also includes a laboratory that carries out pathological, bacteriological and other diagnostic services.
• The central government shall establish a National Council. Its main functions include prescribing standards for clinical establishments and maintaining a register of clinical establishments.
• Every clinical establishment will need to register. The Bill provides for both provisional registration and permanent registration upon satisfaction of prescribed conditions.
• The district registering authority is responsible for registering clinical establishments, inspecting such establishments and cancelling registrations in case of non-compliance with prescribed standards.

Several of these have been criticized. The website also provides a brief analysis of the contentious provisions and issues. These, with a few additions, have been detailed below.

• Cl. 2(c)(i) defines clinical establishments as facilities with beds. Thus, out-patient clinics which comprise 60-70% of private healthcare (Report of the Working Group on Clinical Establishments, Professional Services Regulation and Accreditation of Healthcare Infrastructure (RWG)) are automatically excluded. Independent laboratories and radiology facilities that perform diagnostic and/or investigative services are covered under 2(c)(ii). Outpatient surgery, now-a-days a common feature in the United States (see this report), is beginning to catch on in India as well – several scientific reports have been published involving specific surgical procedures – though no actual numbers are available on the pervasiveness of their practice in freestanding clinics (A good guess may be that less capital intensive procedures (eg. traditional forms of cataract surgery) are more prevelant). Facilities conducting such procedures are usually attached to outpatient clinics, require patients’ presence only for the duration of the operation itself followed by a brief period of post-operative supervision usually amounting in toto to less than a full day and warrant no beds or admission. Such facilities too, notwithstanding the substantive nature of care involved, would not come under the purview of this act.
• Cl. 5 empowers the government to develop ‘proper’ as well as minimum standards for healthcare. The latter alone is to be applied in reviewing the state of any facility. In a country with limited information about the nature and quality of healthcare, no national program for development of practice guidelines or medical review criteria (World Bank Report, 2003) in addition to vast regional and social disparities, creating such standards will be quite a difficult task. The RWG acknowledges this (para 37) and being a long-drawn process, recommends delinking it from registration (para 40(x)), a view incorporated in the draft bill.
• Cl. 10 designates the District Health Officer (DHO) or Chief Medical Officer (CMO) as the district registering authority for registration of clinical establishments in each district. The DHO/CMO also shoulders responsibilities for the management of government facilities in that district. This leads to a conflict of interest.
• Cl. 39 has a limiting stipulation that the register must be maintained in digital format. There is a concern that newer non-digital technologies may therefore be excluded.

Is state regulation a smart idea? This fundamental question at the heart of the debate has no easy answer. The RWG which recommended this step (para 67) does not appear to have seriously debated the merits of this solution. The report discusses briefly the problems of quality and lack of regulation in the private sector (para 6) and from there, jumps to a discussion on the forms of regulation, previous legislations, their inadequacies, and comparative approaches in other countries, with little mention of how legislative enactment will address specific issues, how far it ought to go or why it is a superior approach relative to the rest. It does stress that central legislation is necessary to ensure uniform standards (para 26). However, to foster cooperation and mitigate the skepticism of the private healthcare establishment, the National Council which is tasked with developing standards (Cl. 5) is required to adopt a consultative approach (Cl. 7).
A World Bank (WB) Report from 2003 titled ‘Health Policy Research in South Asia: Building Capacity for Reform’, a goldmine of information on the private sector (the RWG appears to have drawn from it at several places), summarizes the various malpractices that previous studies have noted in the private sector (p. 235): "Stories abound of problems with diagnostic and treatment practices; with inadequate facilities and equipment; and of doctors over-prescribing, subjecting patients to unnecessary investigations and interventions, charging patients exorbitantly, using unethical and irrational practices, and failing to provide information to patients." The report, similar to several other studies, generally favors regulation though its authors (who are all prominent in the field) are not entirely in agreement upon the way forward. One of them recommends decentralization and a better regulatory regime (p .59); a second, writing in greater detail upon this question strongly argues for a ‘minimum set of basic regulations covering the licensing of practitioners and institutions, measures to ensure minimum standards of quality, guidelines regarding pricing, and actions to prevent the oversupply of services (including technology)’ (p. 240); a third, though convinced of the imperative for state intervention, insists that rigorous evaluation is a necessary prerequisite for there is little understanding of the regulatory mechanisms already put in place (p. 250). It must be noted however that many of the studies that recorded evidence of malpractice were not limited to private hospitals and nursing homes. They often focused on individual healthcare providers and also included those operating in exclusively ambulatory clinics with no separate assessment of the proportional contributions in each type of setting. Given the predominance of such clinics, regulatory scrutiny of a large fraction of such ethical violations will be precluded under the terms of this legislation.
The RWG also insists that though ‘state-specific variations would certainly exist, the need of the hour is [to have] uniform standards’ (para 34). The bill, in the statement of objects and reasons, repeats this theme (para 3). All of which brings us to the next question: Is a uniform standard a good idea? The definitive answer will have to wait till these standards are actually enunciated. One can speculate based on the wording of the bill and the RWG of the ministry’s thinking.
Cl. 12(i) entails minimum standards of facilities and services and cl. 12(ii) of personnel, for clinical establishments to meet the requirements of the Act. Regarding facilities, the legislation is likely to have beneficial effects at least with regard to private institutions in urban areas. Important findings previously reported in limited studies have been a lack of hygienic conditions and limitations of space (Nandraj, 1994). Both are easily identified though the latter may be difficult to remedy in a congested urban environment (that study was conducted in Bombay). How much leeway may be offered by the regulating authority for such locations remains to be seen.
Services can be loosely categorized into two: those that directly relate to patient care and those that are either peripheral to patient care but involve interphasing with the public or are more directly concerned with the institution’s own upkeep. The former includes medical, surgical, nursing and other services that directly relate to patient care whose practices are governed by professional guidelines and the conduct of whose professionals, to a significant extent, is overseen by professional bodies and also comes within the ambit of other laws (such as the Consumers’ Protection Act, 1986). Any regulation may end up interfering with not only the jurisdiction of these bodies but affect professional autonomy and are likely to engender profound resistance. However, egregious instances of medical errors that get reported often involve poor professional practice or judgment. Several previous efforts have resulted in little noticeable alteration in practices, their failure being blamed on ‘weakness’, lack of clarity or relevance, strong resistance from practitioners and state apathy (Bhat, 1999; Nayar, 2002). Some provisions to examine medical records for irregularities already exist on the statute in some states but have not been implemented (Bhat, 1996). It remains to be seen whether a similar fate awaits this renewed effort with no verification mechanism put in place to check whether the developed standards are being regularly followed (Prominent instances attracting media attention may still lead to exacting regulatory scrutiny in the absence of a routinely enforced system of auditing records of private health centers). The second kind of services are more amenable to regulation – governments and accreditation agencies usually target them in their efforts to improve quality of healthcare. The same is likely in India also. In fact, the RWG mentions the standards developed by the National Accreditation Board for Hospitals and Healthcare Providers (NABH), a constituent board of the Quality Council of India (QCI) (para 62). Other accrediting bodies have also emerged (para 63 and 64). It is quite possible that the standards adopted finally under this Act will be significantly drawn from some of these existing models.
Personnel problems abound in the healthcare sector. Apart from the widely publicized issue of rural doctor shortage, nursing shortages have also been reported. The vast differences in the number of medical colleges in different states (Supe and Burdick, 2006) also means that the number of graduating physicians will continue to be uneven with location, lifestyle preferences and linguistic barriers potentially preventing large-scale redistribution from overserved to underserved areas. These problems, being rooted in the existing system of incentives and restrictions, are destined to remain for a while. The question here is: how will new regulations affect them? If the medical education system is anything to go by, the answer is: adversely. Professional medical colleges are bound by the standards for faculty recruitment laid down by the MCI and risk losing their recognition should they flout those norms. At the same time, they have been facing an acute shortage of faculty in several (primarily non-clinical) specialties for which the blame is partly laid at the door of the MCI with calls to reduce these requirements to address this issue (Ananthakrishnan, 2007). Similar staff shortages exist in the general healthcare sector as well. Allopathic hospitals sometimes operate with homeopathic house surgeons (Nandraj, 1994) and recruit untrained nurses (Bhat, 1996; WB Report, 2003). If qualification requirements are strictly enforced, private institutions, faced with the prospect of losing their license, may either rise in revolt or resort to a variety of unsavory methods to pass inspection (see ‘Hoodwinking the medical council’ in this news item). In rural areas, this problem has been overcome to some extent by existing personnel performing additional services outside the scope of their training. I knew of a surgeon in a popular rural facility in North Karnataka who also doubled as a gynecologist and was said to be proficient in performing orthopedic surgery when the regular orthopedic surgeon was out of town. The WB Report acknowledges this practice in Uttar Pradesh (p. 274-5) but recognizing that the alternative is the absence of any service, recommends allowing it to continue ‘for now’ with the rider that full disclosure be made by practitioners to community leaders and the public. A proviso to cl. 13(2) insists that ‘in prescribing the standards for clinical establishments, the Central Government shall have regard to the local conditions’. I found this somewhat ironical – are not the notions of uniformity and Central intervention antithetical to the idea of a local solution? Are Central experts truly more conscious and sensitive of local considerations than local health officials? In any case, not providing for some flexibility in the regulations framed under Cl. 12(ii) will certainly hurt rural providers. How these diverse requirements will be handled remains to be seen.
There have also been various reports of a variety of inadequacies in the conduct of individual providers – widespread absenteeism, unfilled vacant posts, incompetence and tardy work ethic (Nandraj, 1994; Das and Hammer, 2004; Hammer et al, 2006). Many of these have been reported in the public sector and the lack of robust accountability practices has been blamed for this (Hammer et al, 2006). How will better regulatory standards impact this? Cl. 42-44 allow the government to levy fines for failing to conform and a proviso to cl. 32(3(b)) allows for the institution to be restrained from ‘carrying on’ if there is imminent danger to the health and safety of patients. As mentioned before (vide supra), with the DHO/CMO holding overall responsibility for government facilities in the district, the ensuing conflict of interest makes it quite unlikely that he/she would be willing to take strong action against erring individuals or facilities. Apart from this, the coercive impact is blunted as any fine levied is merely one arm of the government paying another. There may be more severe consequences if a facility is actually forced to shut down for non-compliance. That is however likely to be a rare event; if it is serious enough to scandalize the government or even otherwise jolt it into action, the finger will once again point to the very DHO/CMO who ordered it. Thus, even if better accountability standards are developed and adopted, these constraints are likely to hamper their effective implementation.
Apart from uniformity between states, the RWG also talks about parity between public and private healthcare institutions (para 36): "Private sector players are quick to accuse the govt. of observing double standards in prescribing minimum standards for private establishments and doing nothing to improve the pathetic conditions in public health institutions. This issue would need to be addressed in the right spirit by the government. No exemptions have been provided for government institutions in laws framed for management of bio medical waste, setting up of blood banks and pre-natal diagnostic tests etc. All these laws have had salutary impact on their specific areas. All the more reason that government establishments should also be required to register and comply with prescribed standards." On the face of it, the initiative is a laudable one. However, Ajay Mahal, in the WB Report from 2003, quoting classical economic theory has this to say (p. 59): "…particularly the suggestion to improve the quality of public sector care, run[s] into the problematic observation made by Besley and Coate (1991) that greater equity can be achieved and insurance for the poor improved if the quality of available public services is not ‘too high’. They argue that the interests of the poor could be served by the public sector if the richer groups start using private care or unsubsidized public facilities such as paid inpatient wards. For this to happen, however, the nonpoor would have to perceive the quality of care in the private, unsubsidized facilities as being better than that of subsidized public services." He also found that the BIMARU states and Orissa have the least egalitarian distribution of public health subsidies, i.e., the wealthier sections use public health facilities more than the poorer sections of society. If the prescribed minimum standards are high enough to require both public and private establishments to upgrade their facilities causing greater parity, it might then end up worsening the targeting of subsidies to impoverished sections and enhance healthcare disparities. The same result would also occur if private establishments, finding themselves unable to meet the requirements, simply shut shop or move elsewhere.
The Indian Medical Association (IMA) which has consistently resisted state regulation, not surprisingly, came out against this particular effort also. As it alleges, this is, in a sense, a return to the license-permit raj with registration and inspection becoming potential focal points of corruption.
In conclusion, in a highly diverse country such as ours, I remain skeptical about a nationwide effort to bring uniformity through state-mandated regulation. The Act may well have some positive effects characterized by noticeable improvements in the urban private sector institutions. However, a full assessment must include the entire array of costs and benefits incurred by all constituent parts of the healthcare system as well as its participants. Only a few states have so far signed on to this initiative. If this remains the case, it may eventually provide an opportunity after it has been implemented (if at all it comes into effect), to examine, through comparative analysis, how effective it has turned out to be.