Return to the inspector raj?

The coming monsoon session of Parliament is slated to be crucial for the healthcare sector as the Clinical Establishment (Registration and Regulation) Act 2007, is to be tabled for discussion. Health Minister Anbumani Ramadoss first spoke about the proposed Act in 2006 as a means of registration and regulation of clinical establishments.

The background to this proposed Act is interesting. In 2000, the Union Government had asked state Governments to impose minimum standards for clinical establishments. The Planning Commission had constituted a Working Group on Clinical Establishments, Professional Services Regulation and Accreditation of Healthcare Infrastructure for the 11th five year plan (2007-2012). The Report on the Working Group mentions that though the for-profit private sector accounts for a substantial portion of healthcare in India (50 per cent of inpatient care and 60-70 per cent of outpatient care), it has received relatively less attention from policy makers as compared to the public sector.

Thus, the private sector healthcare delivery system in India, according to the Report, has remained "largely fragmented and uncontrolled, and there is a clear evidence of serious quality of care deficiencies in many practices." Problems cited in the Report range from inadequate and inappropriate treatments, excessive use of higher technologies, and wasting of scarce resources, to serious problems of medical malpractice and negligence. The current policies and processes for healthcare are alleged to be inadequate or not responsive to ensure healthcare services of acceptable quality and prevent negligence.

Though some states like Maharashtra, Andhra Pradesh, Orissa, Punjab, Manipur, Sikkim, Nagaland and Madhya Pradesh have instituted laws (like Maharashtra's Bombay Nursing Homes Registration Act, 1949 to name just one of them), the Central Government is of the view that these laws are outdated and are therefore ineffective, leading to no accountability in the system.

Therefore the Ministry of Health and Family Welfare was entrusted with the task of preparing fresh legislation and this is how the Clinical Establishment (Registration and Regulation) Act 2007 came into existence. At various public forums, the Health Minister has outlined his intentions of cutting down private healthcare costs once this system has been implemented. These measures include rationalising purchase of imported medical equipment and replacing these with indigenous products. So also, in the case of pathology laboratories, the Minister opined that patients have no way of knowing which centre was better equipped and often got concerned when they got differing results from different laboratories. Thus quality levels need to be defined and maintained and the Government seems to believe that the healthcare industry needs a watchdog to do this. Besides lifting general healthcare standards, the regulators are of the view that this 'seal of approval' will also attract more medical tourism to the country.

The regulation, once passed, would apply immediately to the states of Arunachal Pradesh, Himachal Pradesh, Mizoram and Sikkim and the Union Territories, and other states which choose to adopt this Act.

If the Bill is passed and becomes an Act, clinical establishments will get two years (from the time the law comes into force) to apply for mandatory registration. After that, the nodal registering body will make the act mandatory for one and all. The Act will be implemented through a three-tier structure with officers at the district, state and central level. The law also seeks to standardise all medical facilities available either in Government and private hospitals, according to government officials. Not surprisingly, private healthcare players feel suspicious of the government's stated objectives and are vigorously opposing the legislation as a means of tying them up in yet more red tape. They point out that the current system of state legislature is sufficient as it is more in touch with state-wise health infrastructure needs and realities. If the aim was to raise standards, then major private players are self-regulating and already have accreditations to Joint Commission International (JCI) and National Accreditation Board for Hospitals and Healthcare Providers (NABH) in India and many more are gearing up for the same. Medical tourism is not a problem with such accreditations.

Industry observers allege that once made into law, the Act seems to be ploy to control private players in the industry under the guise of instituting uniform standards and rationalising costs.

A good idea would be to consider how other countries have handled the situation. Industry sources point out that most countries have a system of hospital accreditation which importantly, also covers outcomes. This is a voluntary initiative by hospitals, and the accreditation agencies are independent entities, which have come to be recognised by both governments and insurers. Therefore the providers, regulators and payors are all on the same page and are all involved in proposed regulatory changes. In the case of the proposed Clinical Establishment (Registration and Regulation) Act 2007, however, industry insiders point out that the rules are made by bureaucrats who would not understand realities of the healthcare business. The consensus seems to be that it's too early for such regulation to be implemented and if implemented, it has to be done evenly across both public and private sectors.

Obviously, there needs to be more debate and discussion on the subject before a solution acceptable to all stakeholders is hammered out. Any unseemly haste to push the legislation will only increase opposition and suspicion as to the real intentions of the regulating authorities.

Viveka Roychowdhury
viveka.r@expressindia.com