QPMPA Comments on Kerala Clinical Establishments Bill, 2012

Before the Health Ministry, Kerala

Clinical Establishments (Registration & Regulation) Bill, 2012


The first demand to register private hospitals came from the National Human Rights Commission in 1996 following the death of one Ina Raja in a private hospital. The Central Council of Health and Family Welfare demanded it in 1997 & 1998. Consequently, the National Institute of Health & Family Welfare was assigned the responsibility of drafting a model legislation. The same was circulated to all State Governments in February 1999. The question of Emergency Medical Services came up next in the 2003-04 Annual Report of the National Human Rights Commission.

In 2006, the Law Commission of India through the 201st Report on Emergency Medical Care to Victims of Accident and during Emergency Medical Condition and Women under Labour presented the issue before the Hon’ble Health Minister of India. In view of the judgments of the Supreme Court and the National Consumer Redressal Forum and the fact that there is no appropriate legislation on the subject, the Law Commission of India took up the subject suo motu. It proposed recommendations and presented a draft Model Bill for the purpose of emergency treatment.

In May 2006, the Govt. of India constituted the Working Group on Clinical Establishments, Professional Services Regulation and Accreditation of Health Care Infrastructure for the 11th Five-Year Plan. As directed in the 11th Plan report the Kerala State drafted a Bill in 2009 — The Kerala Clinical Establishments (Registration, Accreditation & Regulation) Bill, 2009, giving more importance to accreditation of clinical establishments. That was shelved and a new draft is before us to regulate healthcare institution in public & private sector without giving adequate representation for the stakeholders.

In 2010, the Central Clinical Establishment Act (CEA) became a reality as requested by five states in India and we are proud of our planners for enacting this legislation of national importance in a short span of 14 years.

Proposals by the QPMPA

The State Govt. informed the QPMPA that there would be a meeting on 7 Nov. 2012 in the chamber of the Hon’ble Health Minister at Trivandrum to finalise the draft on “The Kerala Clinical Establishments (Registration & Regulation) Bill, 2012.

The QPMPA convened an emergency meeting on Sunday, 4 Nov. 2012 at its headquarters at Kochi and decided to propose before the Govt. the following unanimously –

1. Representation: - The QPMPA represents more than 2,500 private sector hospitals, nursing homes, and clinics out of the nearly 3,500 such institutions in Kerala. We humbly request the Government to include the State level officers of QPMPA in the proposed State Council of CE (R & R) Act and the district officers at the District level councils.

2. GDP share by Private sector: - The private sector is constituting nearly 72% of the GDP in health and it is only natural to accommodate the Private sector associations in the Councils and must be given 2/3 representation in all the committees associated with the Kerala CE Act.

3. Definition of a Hospital/Nursing home/clinic: - Section 2 (b) of the Bill defines “clinical establishments” and that has named the various institutions and the nomenclature used to identify them and the activity involved. The question involved is whether a “clinical establishment” is an Industry, Commercial activity, a shop, a business or a service activity helping the government fulfil its obligations to the people. Majority of the owners of “private Clinical establishments” are doctors and next comes the Church. We run this as a service and charity and we want it that way and continue to serve the people. Hope the Govt. will appreciate and accept our stand.

4. A single Window clearance & The need for CE Act in Kerala: - Healthcare institutions in Kerala are under the watchful eyes of 55 Central, 45 State and 15 other miscellaneous Acts and Rules. Addition of CE Act will take the total to 116 windows for clearance to run a clinical establishment. We humbly request the Govt. of Kerala to bring us under a single window and we have no objection if that is Clinical Establishments Act. This will improve efficiency in delivery of healthcare, save cost, time and ultimately prevent corruption and harassment. A clause may be added to overcome official delays in granting licences to hospitals. If there is no communication from the authority on an application for registration within 30 days, that shall be construed as granting of registration to the establishment.

5. Protection of Small & Medium Medical Establishments (SMEs):- The draft bill on Clinical Establishments is silent on any mechanism to protect the SMEs, which has the maximum penetration to the rural areas. They work under the Family Medicine concept. In our tropical climatic conditions with high rate of infectious diseases, the SMEs have a major role in control and eradication of diseases. Destruction or demoralisation of SMEs will lead to the return of once eradicated diseases and emergence of new ones. These SMEs keep the cost of healthcare to low levels affordable to the public.

6. Emergency Treatment: - The definition of “emergency medical condition” is a true copy of that from the Law Commission Report. In the 2003-04 report, the Law Commission came out with a draft bill to ensure emergency treatment to victims of accident and others. In that draft bill, they have also given the details of the authority to decide an emergency condition and have given ways and means to recover the cost involved in emergency treatments. It is true that many SMEs and even major hospitals deny treatment to victims of accident, etc. The major reasons are harassments by the relatives of the victims, monetary and the legal issues involved. The Govt. must be more practical in this issue and imposing huge penalties will not solve the problem.

7. Stabilisation: - We are not against giving First Aid in the Golden Hour. In Modern Medicine, it is impractical to stabilize the patient in many of the cases especially in primary and secondary set up. Making it mandatory through an Act is not democratic and will not serve the purpose. When it is made mandatory through an Act, all the doctors will try hectically to stabilize the patient which will make the patient lose the Golden hour and may even end up in death of the patient and the Government will be responsible for the consequences. The doctor involved cannot be tagged with the life of a patient.

8. Banning the aggrieved from approaching Courts: - Clause 50 is in violation of the fundamental rights of the citizens and be deleted.

9. Penalty: - Imposing hefty sums as penalty is not the democratic remedy. The Penalty clause will only help in under the table compromises to set things right. The penalty should be at par with other professions.

10. Classification: - There should be a reasonable classification of Clinical Establishments in the rules and we propose the following –

a) GP Consultations – one or two doctors
b) Specialist Consultations – one or two doctors
c) Small hospitals with less than 20 beds
d) Medium hospitals with 20 to 100 beds and three or 4 specialities
e) Major hospitals with more than 100 beds & more than four specialists
f) Medical Colleges.

11. Rate Chart: - Professional services by the medical profession cannot be equated to that of other services in a hotel, shop or bank. The charges or the final bill for an ailment varies with the age, clinical conditions, associated diseases and many other factors. Depending on the qualifications and experience of the doctor, his consultation fees will vary. Depending on the facilities available, the charges in a hospital will also vary. Exhibiting the rate chart is practically impossible since it is unpredictable.

12. Grievance Clause No. 40: - The patients are already having consumer redressal forum and many avenues to approach with their grievances. So this clause should be deleted. On the other hand, the doctor is not having that option. So this clause should be modified to hear the grievance of doctors/hospitals. There is no provision or place for the doctors or the hospitals to approach with their grievances.

13. Up gradation of Clinical Establishments: - The rules associated with this Act will naturally demand high standards for all clinical establishments. The SMEs will never achieve those targets in the normal course. Soft loans must be given to SMEs if the Govt. is serious in the survival of SMEs. Since the very existence of SMEs is threatened by the corporate sector it must be the duty of the Govt. to support them to keep the out of pocket expenditure of the public within affordable levels.

Thanking you.

Dr. M. A. Koya,
State President, QPMPA

7 November 2012