The Clinical Establishments (Registration and Regulation Act) Bill, 2010

The Clinical Establishments (Registration and Regulation Act) Bill, 2010 — approved by the Union Cabinet last month — makes it mandatory for all clinical establishments to provide medical care and treatment to stabilize any person in an emergency condition.

If the Bill is passed in Parliament, this will be the first time emergency medical care is made obligatory under law in the country.

While there is no provision for imprisonment for non-compliance, the registering authority can impose a heavy fine — up to Rs. 5 lakh — on the erring establishment. If it fails to pay, the fine will be recovered as arrears of land revenue.

In 1989, the Supreme Court gave directions that emergency care be not denied to victims under any circumstances. The Law Commission also recommended legislation to make it mandatory.

Accident victims are often referred to government hospitals from private facilities to avoid legal hassles. Also, women are turned away from private hospitals and nursing homes if they fail to deposit money in advance.

As per the Bill, all clinical establishments will be required to register themselves with the State Council for Clinical Establishments. These include hospitals, maternity homes, nursing homes, dispensaries, clinics and similar facilities with beds that offer diagnosis, treatment or care for illness or injury or pregnancy under any recognized system (allopathy, Yoga, naturopathy, Ayurveda, Homoeopathy, Siddha and Unani). Clinical establishments also include any laboratory (an independent entity or part of an establishment) which offers pathological, bacteriological, genetic, radiological, chemical, biological and other diagnostic or investigative services.

Whether the establishment is owned by the government or a department of the government, a trust (public or private), a corporation (including a cooperative society), a local authority or an individual, registration will be compulsory. The clinical establishments of the armed forces have been excluded from the purview of the proposed legislation.

The legislation will help in addressing unregulated growth of the private sector, often accused of inadequate treatment, excessive use of higher technology, medical malpractices and negligence. It would also empower the State governments or the Registering Authority to direct any clinical establishment to furnish details, statistics or any other information. This would be extremely useful for monitoring outbreaks of diseases.

THE CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) BILL, 2010

STATEMENT OF OBJECTS AND REASONS

1. At present, the supervision and regulation of the quality of services provided by the health care delivery system to the people by both public and private sectors has largely remained a contentious and therefore, unresolved issue. The current structure of the health care delivery system does not provide enough incentives for improvement in efficiency. The private sector health care delivery system in India has remained largely unregulated and uncontrolled. Problems range from inadequate and inappropriate treatment, excessive use of higher technologies, and wasting of scarce resources to serious problems of medical malpractice and negligence.

2. Despite many State Legislatures having enacted laws for regulating health care providers, the general perception is that current regulatory process for health care providers in India is inadequate or not responsive to ensure health care services of acceptable quality and prevent negligence. Concerns about how to improve health care quality have continued to be frequently raised by the general public and a wide variety of stakeholders, including Government, professional associations, private providers, agencies financing health care, National Human Rights Commission and also by judiciary.

3. Accordingly, a need has long been felt for a central legislation for ensuring uniform standards of facilities and services by the clinical establishments throughout the State where the Legislative Assemblies have passed resolutions under article 252 of the Constitution and the Union territories and the States which may adopt the legislation by such resolutions.

4. In view of the above, the Clinical Establishment (Registration and Regulation) Bill, 2007 was introduced in Lok Sabha on the 30^th August, 2007 and the same was referred to the Department-related Parliamentary Standing Committee on Health and Family Welfare which made certain recommendations on the provisions of the said Bill. However, the said Bill was lapsed due to dissolution of the Fourteenth Lok Sabha.

5. It is now proposed to introduced the Clinical Establishments (Registration and Regulation) Bill, 2010 on the lines of above Bill incorporating therein certain recommendations made by the Department-related Parliamentary Standing Committee on Health and Family Welfare.

6. The salient features of the proposed legislation, inter alia, are as follows:—

(i) the proposed legislation provides for the constitution of a National Council consisting of representatives of Medical Council of India, Dental Council of India, Nursing Council of India, the Pharmacy Council of India, the Indian Systems of Medicines representing Ayurveda, Siddha, Unani and Homoeopathy systems, the Indian Medical Association, the Bureau of Indian Standards, the Zonal Councils setup

under the States Reorganisation Act, 1956, the North-Eastern Council, etc.;

(ii) the function of the National Council shall be to determine the standards for the clinical establishment, classify the clinical establishment into different categories, develop the minimum standards and their periodic review, compile, maintain and update a National Register of clinical establishments, perform any other function determined by the Central Government, from time to time;

(iii) the function of the State Council shall be to compile, maintain and update the State Registers of clinical establishments and to send monthly returns for updating the National Registers. The State Councils shall also publish reports on the implementation of standards within their respective States, annually;

(iv) the concerned State Governments shall, by notification, set-up an authority to be called the district registering authority under the chairmanship of District Collector for registration of clinical establishments;

(v) no person shall carry on a clinical establishment unless it has been registered in accordance with the provisions of the proposed Bill. The legislation would not apply to the clinical establishments of the Armed Forces;

(vi) it is proposed that clinical establishments already in existence may be allowed for provisional registration to carry out their business. There shall be no prior enquiry for provisional registration. But the authority shall have power to make enquiry in accordance with such rules as may be prescribed.

(vii) the clinical establishment having provisional registration shall fulfil the standards which may be notified for the purpose. The provisional certificate shall not be granted or renewed beyond a period of two years from the date of notification of standards;

(viii) any clinical establishment may apply for permanent registration in such form and shall pay such fee as may be prescribed by the State Government. A detailed procedure for permanent registration is being provided in the proposed legislation;

(ix) the authority shall have power to cancel the registration of the clinical establishment which fails to comply with the conditions prescribed by the Central Government. The authority shall have power to inspect a registered clinical establishment. Any person aggrieved by an order of the registering authority shall prefer an appeal to the State Council;

(x) the clinical establishments shall undertake to provide within the staff and facilities available, such medical examination and treatment as may be required to stabilise the emergency medical condition of any individual who comes or is brought to such clinical establishment;

(xi) the certificate of permanent registration issued by the authority is valid for a period of five years from the date of issue;

(xii) there shall be register of clinical establishment at the district level, State level and the National level;

(xiii) if any person contravenes any provisions of the proposed legislation or any rules made thereunder, he shall be punished with fine. The maximum penalty being provided is rupees five lakh;

(xiv) conferring power upon an authority, to levy monetory penalty for violation of the provisions of sections 41 and 42 of the proposed Bill;

(xv) any person aggrieved by the decision of authrity may prefer an appeal to the State Council.