Three laws, multiple prescriptions 

Three laws, multiple prescriptions 

Context

What are the norms private medical practitioners follow in West Bengal, in Karnataka and in multiples states and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010 passed by Parliament?

Backdrop

Both West Bengal and Karnataka’s Acts prescribe different regulatory structures from that envisaged in the Clinical Establishments (Registration and Regulation) Act 2010 (CEA), passed by Parliament for regulation of the private healthcare sector

Similarity

All three Acts require a mandatory registration of medical establishments, albeit with different

authorities

Differences

Regulatory authority supervising medical establishments:

West Bengal

• West Bengal Clinical Establishment Regulatory Commission: Under the West Bengal Clinical Establishments (Registration, Regulation and Transparency) Act, 2017, the West Bengal Clinical Establishment Regulatory Commission constituted by the state government is tasked with the “regulation and supervision of the functioning and activities of the clinical establishments”
• Chairperson: The chairperson is a former High Court judge, a former chief secretary or additional chief secretary in the state government or a similarly ranked person in the government of India
• Vice-Chairperson: The vice-chair is a “person of eminence” and members are selected from diverse fields, including medicine, law, public health, academics, social services and consumer interests. All members are appointed by the government

Karnataka

• District Metropolitan Grievance Redressal Committee: In the Karnataka Private Medical Establishments Amendment Bill, 2017, tabled in the state Assembly recently, the District Metropolitan Grievance Redressal Committee has been given the authority to inspect a private medical establishment to check if provisions of the Act are being followed
• Political leadership of the committee:This body is led by the chief executive authority of the zilla panchayat — the fact that a political person heads the committee is a major reason of unrest amongst doctors
• Members of the committee: The authority consists of the district superintendent of police, the district surgeon, one representative of private medical establishments in that district, the public prosecutor and one nominated woman representative

Clinical Establishments Act 2010

• National Council of Clinical Establishments: CEA 2010 prescribes a national council of clinical establishments. It is tasked with the registration of all medical establishments after ensuring that minimum standards are adhered to. Each state has to have a state council with a similar mandate
• Chaired by:The National Council of Clinical Establishments, as laid down in the CEA 2010, is chaired by the Director General of Health Services, with one member each elected by the Dental Council of India, the Medical Council of India, the Pharmacy Council of India and the Nursing Council of India, three by the Central Council of Indian Medicine, one by the Central Council of Homoeopathy and one by the Indian Medical Association. In addition, there are members from the Bureau of Indian Standards, national-level consumer groups, the North Eastern Council, etc.

Difference in Penal provisions

Each Act also has different approaches to penal provisions overseeing the private practice of medicine

Karnataka

Of the three acts, only the Karnataka version has provisions prescribing jail terms for contraventions of the Act

• A person convicted of running a medical establishment without registration can face a prison term of upto three years and a fine of upto Rs 5 lakh
• A violation of registration conditions can be met with provisions for a prison term of three years or a fine of upto Rs 1 lakh
• Failure to inform the public about the charges for various services would attract a prison term of six months to three years and a fine of upto Rs 5 lakh

West Bengal

The West Bengal Act provides for a fine of upto Rs 1 lakh for non-registration of clinical establishments and a penalty of Rs 1,000 per day after that up to a maximum of Rs 10 lakh

• Disobedience can invite a penalty of upto Rs 5 lakh, as can willful destruction or falsification of medical records
• The penalty for medical negligence as specified in the Act can range from Rs 3 lakh for a simple injury to Rs 10 lakh for death

CEA 2010

In the CEA 2010, the penalty for contravention ranges from Rs 10,000 for the first offence, which goes up for every subsequent offence, to a maximum of Rs 5 lakh

• Willful disobedience or withholding of information can attract a fine of a maximum of Rs 5 lakh. Significantly, the provisions apply to government departments too

Difference in treatment of general obligations

There are also marked differences in how the three Acts treat the general obligations of medical establishments.

Karnataka

• Under the Karnataka Act, medical establishments have to conform to standards laid down in this Act or the rules made therein, and also make available, for the information of patients and the general public, the schedule of charges payable for different medical treatments and other services, using brochures, booklets and notice boards.
• Every establishment has to maintain clinical records and mandatorily treat victims of road traffic accidents or criminal assaults whenever they come to a hospital
• According to the patients’ charter, every patient has the right to complete information on the disease, treatment and medical procedure and a right to give informed consent on his or her own course of treatment

West Bengal

The West Bengal Act says that,

• Every establishment will have to follow fixed rates, including package rates for medical investigation, bed charges, operation theatre procedures, implants, ICU charges, etc., and also provide proper estimates for treatments not covered in packages
• Establishments are also required to mandatorily obtain consent for the continuation of ventilator support after a patient is declared brain-dead

CEA 2010

The CEA 2010 envisages registration as the cornerstone of regulation, with registration conditions placed in the domain of the state government

• As part of the enforcement plan of the Act, standard treatment guidelines have so far been prepared for 21 specialty areas, including endocrinology, oncology, neurology, orthopaedics and cardiovascular diseases
• Guidelines have also been prepared for treating common problems like snake bites, dry eye disease, epilepsy, diabetic foot and osteoarthiritis of the knee