Doctors and Hospitals
Profession or Industry?
Challenges in regulation
The Cauldron
• Rise of consumerist culture in society.
• Transition
in
medicine
from
clinical
medicine to evidence based medicine.
• Type of medical practice shifting from
individual practitioners to hospitals.
Why is it a challenge
Ethics is a dynamic concept changing
with time and space
Doctors: Profession : Professional ethics
Hospitals : industry: business ethics
The bias
Hospitals :Professional service
or
commerce?
For service : Profession
For regulation:trade/industry/business
Lack of sensitivity
1) Consumer protection act
2) Shops and commercial
establishment act
3) Dangerous trade and offensive
practices act
4) Sales tax/VAT
5) Luxury tax
6) Service tax
Lay man’s approach
1)Clinical establishment(registration and
regulation )Act 2010
a)stablisation clause
b)fixing of charges
c) Licensing nature
d) Presence of a police officer in licensing
team.
e)Complaints cell.
Lay man’s approach
2) The Indian Medical Council
(professional conduct,etiquettee and
ethics) Regulations 2002
a) display of charges(3.7.1)
b) sections 7.23,7.24
Lay man’s approach
3) PCPNDT Act
a) List of indications for scan
b) Lack of connectivity to female
foeticide.
Under regulation or over
regulation ?
Plethora of laws and regulations
Laws governing health care
institutions
Laws regarding service delivery
1.
The Drugs and Cosmetics Act,1940(Central Act of 23 of 1940) and
Rules 1945
2.
The Pre-Conception and pre-Natal Diagnost Techniques(Prohibition
of sex selection)Act ,1994 Rules 1996
3.
The Medical Termination of Pregnancy Act,1971 and Rules 2003
4.
The Kerala Intoxicating Drugs(Control)Rules,1983
5.
The Drugs (Prices Control)Order ,1995
6.
The Kerala Narcotic Drugs and Psychotropic Substances Rules,1985
7.
The Mental Health Act,1987 Rules 1990
8.
The Drugs and Magic Remedies (Objectionable Advertisements)Act
1954 and Rules 1955
9.
Laws governing health care
institutions
The Kerala Corneal Grafting Act and Rules 1963
10. The Creation of Eye –Bank Rules ,1970
11. Blood Bank Licence
12. The Transplantation of Human Organs Act,1994 and Rules
1995
13. The Clinical Thermometers(Quality Control)Order,2001
14. The Poison Act,1919(central Act XII of 1919)the Kerala Poison
Rules 1960
15. The Standards of Weights &Measures Act,1976(Central Act 60
of 1976)& The Standards of Weights& Measures (Enforcement)
Act, 1985(Central Act 54 of 1985)
16. Atomic Energy Act 1962
Laws governing health care
institutions
Laws regarding the Professionals :-
17. The Indian Medical Council Act ,1956 Regulations,2000
18. The Indian Medical Council(Professional Conduct ,Etiquette
and Ethics )Regulations ,2002
19. The Indian Medical Degrees Act,1916
20. The T.C. Medical Practitioner Act ,1953
21. The Indian Nursing Council Act,1947
22. The Nurses and Midwives Act,1953 Rules 1972
23. The Pharmacy Act,1948
24. The Pharmacy Council of India Regulations,1952 Rules 1961
25. The consumer Protection Act 1986,(Central act 68 of 1986)and
Rules 1987
Laws governing health care
institutions
Laws regarding the Institutions:-
26. Clinical Establishment (Registration and Regulation )Act 2010.
27. The Kerala Shops& Commercial Establishments Act,1960 and
Rules 1961
28. The Bio medical waste (management and handling )rules 1998
29. The Kerala Panchayat Raj (Registration of private Hospitals
and Private paramedical institutions)Rules,1997
30. The Kerala Municipality (Registration of Private Hospitals
and Private Paramedical Institutions)Rules 1997
Laws governing health care
institutions
31. The Air Act,1981
32. The Water Act,1974
33. The Kerala Building Tax Act 1975 Act 7 of 1975
34. Dangerous trades and offensive practice act
35. The Kerala General Sales Tax Act,1963/KVAT
36. Luxury Tax Act
37. Service Tax Act
Laws governing health care
institutions
Laws regarding Labour:-
38. The Minimum Wages Act,1948(Central Act 11 of 1940)& Rules,1950
39. Payment of Wages Act 1936
40.The Maternity Benefit Act ,1961
41.The National and Festival Holidays Act
42.The Gratuity Act 1972
43.Weekly Holidays Act ,1942(Central Act 18 of 1942)
Laws governing health care
institutions
44. The Employees State Insurance Act
45. The Payment of Bonus Act,1965 (Central Act 21 of 1965) &Rules, 1975
46. The Employees Provident Fund and Miscellaneous Provisions Act
1952(Central Act 19 of 1952)
47. The Kerala Welfare Fund Act II of 1977
48. The Kerala Labour Welfare Fund Act ,1975 (Act II of 1977)
49. The Industrial Employment (Standing Orders)Act 1946
50. The Industrial Disputes Act 1947
51. The Kerala Payment of subsistence Act ,1972(Act 27 of 1973
Need for benign approach by state
1)MTP Act
2) Special Protective sections :88,87 and 80 IPC
3) Circular memorandum 1993 Government of
Kerala.
4)Supreme court pronouncement
Profession
or
Trade/commerce/industry?
“By any standards that one may adopt, medicine is
and ought to be a profession and not a mere
career or just an income earning activity. This can
be no different even when the professional
activity becomes more and more organized and
assumes larger dimensions.
The dividing line between professions and mere
careers is getting blurred increasingly, we do
hence find laws and regulations increasingly
entering into zones which were left to the sound
discretion of the professionals in yesteryears.
Ethical professional standards and not the mere
stipulations of law must provide the beacon light
for any conscientious professional”.
Justice R Basant.
Suggestions:1. All laws regarding doctors, allied professions
and healthcare delivery institutions should
be based on the ethics and etiquette of
medical profession. They should be given
special status in law.
2. Single window for all legislations governing
health care institution.