Dr. JAYAKRISHNAN.A.V.

CO ORDINATOR,

Committee for Medicine & Law

State Secretary, IMA Kerala

COMMITTEEFOR

MEDICINE & LAW

TOO MANY LAWS GOVERNING THE HEALTH SECTOR

HEALTH CARE PROVIDERS FEEL THAT THE SECTOR IS OVER REGULATED

LAW MAKERS AND ADMINISTRATORS FEEL THAT THE SECTOR IS UNREGULATED

SCENARIO

(i) Medical Education: This topic again encompasses a number of issues right from recognition of qualifications, recognition of educational institutions, the courses of study, right of admission and various other aspects concerning rights of medical students, etc.

(ii) Entitlement to medical practice and the limitations of the same: What does a given degree entitle you to practise? Can an allopathic doctor prescribe Homeopathic medicines, etc.

(iii) Control over medical practice: Machinery which will ensure the enforcement of the laws referred to above.

Areas covered

(iv) Obligations of doctors and medical ethics: The obligations of doctors to other doctors, to patients and to the society are codified in the code of medical ethics.

(v) Medical malpractice laws: These deal with malpractice and negligence and the machinery to bring doctors to book such as Medical Councils, Consumer Courts, etc. A small part of medical malpractice accompanied by the unethical conduct is covered under the medical council acts while the rest falls under the tort law, criminal laws and the consumer protection act

Areas covered

(vi) Drug dispensation and Drug laws: These are covered under the acts for pharmacists and the pharmaceuticals.

(vii) Control over hospitals and Nursing Homes

Areas covered

MCI ACTUNIVERSITIES ACTOTHER COUNCILS

recognition of educational institutions the courses of study right of admission various other aspects concerning rights of

medical students, etc.

MEDICAL EDUCATION

Medical degreesMCI ActTrainings and certificates

Encroacment & quackery

ENTITLEMENT OF MEDICAL PRACTICE

Medical councilGovernment controlProtocols and guidelinesStandard practiceAdvancementsTrial & experiments

CONTROL OF MEDICAL PRACTICE

Trade or professionSelf regulationEthics and lawIndividual Vs Institution

MEDICAL ETHICS

a) Consumer Dispute Redressal Agencies.b)

Medical Council of India and Dental Council of India.

 c) Civil Courts.  d) MRTP (Monopolies and Restrictive Trade Practices Commission)  e) Public Interest Litigation.  f) Sections of Indian Penal Code, 1860 (Criminal courts)

g)Other Agencies (i)Human Rights Commission (ii)Vanitha

Commission (iii) Lok Adalat

MEDICAL MALPRACTICE LAWS

Magic remedies act

Drugs and cosmetics act 1945

DRUG DISPENSATION & DRUG LAWS

Nursing homes registration act of various states

Clinical establishment act

CONTROL OVER HOSPITALS

CPA act Passed in 1986Medical profession introduced in 1995

following supreme court verdict in V.P.shantha Vs IMA case

Jacob Mathew case, Martin D’Souza case and Nikhil superspeciality case

(i) lata culpa, gross neglect(ii) levis culpa, ordinary neglect, and(iii) levissima culpa, slight neglect.

Consumer Dispute Redressal

To do scientific analysis regarding CPA casesTo find out possible solutionsAmendments, expert panel, capping of

compensation, special fund etc.Proceed with legal measures

CPA

No practitioner should be booked under the provisions except under extraordinary circumstances

The provisions has to be clearly defined

CRIMINAL NEGLIGENCE

Although MCI is called the regulatory body, it has limited regulatory role

NOC for medical colleges decided by the state govt.

Syllabi modified by respective universitiesNo financial and administrative autonomyOverlap of portfolios with other councils and

agenciesNominated representatives outnumber

elected onesRepresentation from states erratic and not

according to the number of registered practitioners

MCI ACT

For Registration and regulation of clinical establishments.

State councilDistrict authority of registrationProvisional and Permanent registrationCancellationPenalties

CLINICAL ESTABLISHMENT ACT

Appeals and RevisionGrievance RedressalInspection and Power to enter

HIGHLIGHTS Contd…..

PROVISIONAL For One yearPERMANENT For 3 years issued only after inspection and

minimum standards are met. institution will be categorised.

REGISTRATION

Registration can be cancelled for various reasons envisaged in the act.

Penalty ranging from 50,000 to 5,00,000

CANCELLATION & PENALTY

Appeals and revisionAppeals to the councilRevision by government

Grievence redressalCouncil to set up a grievence redressal mechanism to receive complaints against the establishment.

Inspection and Power to enterThe council, the authority or an authorised person can inspect/ enter the clinical establishment at any time.

The participating associations unanimously resolve that proposed Clinical Establishments bill is irrelevant and not required for our state.

However the associations agreed on the following points

Registration of clinical establishments and maintenance of appropriate standards are necessary.

Govt regulation through licensing process is not required.

The state council should have a representative character of stake holders.

OUR DEMANDS

The institution may conform to the prescribed standards through independent accreditation agencies and this should be adequate for registration without inspection by Govt agencies.

State level council is adequate. District authority is not necessary.

A minimum of 5 yr period should be given to the institutions to achieve the standards.

This state authority should provide a single window for all legislations and regulations.

The stabilization clause is unrealistic and should be deleted.  The act should include provision for promotion of clinical

establishments.The penalty clauses and complaint cell should be deleted.

OUR DEMANDS Contd…

There are varieties of rights given to people, by law or recognised by law: (1)Fundamental rights given by the constitution, (2) Constitutional rights not having

status of fundamental rights, (3) Statutory rights, (4) Rights flowing from subordinate legislation. (5) Rights based on case law, (6) Customary rights, (7) Contractual rights.

Article 47Public health act

RIGHT TO HEALTH

The Medical Termination of Pregnancy Act and Rules The Pre-Natal Diagnostic Techniques (PNDT) Act and Rules Acts in Disability Insecticides Act and Rules Maternity Benefit Act and Rules Narcotic Drugs and Psychotropic Substances Act and Rules The Prevention of Food Adulteration Act, 1954 Drugs and Cosmetics Act, 1940 Bio-Medical Waste (Management and Handling) Rules, 1998 The Pharmacy Act, 1948 The Transplantation of Human Organs Act and Rules Environmental Acts and Rules Consumer Protection Act and Medical Profession Mental Health Act, 1987 Food Safety and Standards Regulations The Protection of Women From Domestic Violence Act, 2005 The Marriage Laws (Amendment) Bill, 2010 The Prohibition Of Sexual Harassment Of Women At Workplace Bill, 2010 Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011 Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011

SOME LAWS DIRECTLY RELATED TO HEALTH

List of Licenses and Statutory Obligations

All of them might not be applicable to all the Hospitals:

1. Building Permit (From the Municipality).2. No objection certificate from the Chief Fire officer.3. Bio- medical Management and handling Rules, 1998.4. No objection certificate under Pollution Control Act.5. Radiation Protection Certificate in respect of all X-ray, Cath lab

and CT Scanners from BARC.6. Atomic energy regulatory body approvals.7. Excise permit to store Spirit.8. Income tax PAN.9. Permit to operate lifts under the Lifts and Escalators Act.10. Narcotics and Psychotropic substances Act and License.11. Sales Tax Registration certificate.12. Vehicle registration certificates for Ambulances.13. Retail and Bulk drug license (Pharmacy).14. Wireless operation certificate from Indian post and

telegraphs, (if applicable)15. Air (prevention and control of pollution) Act, 1981 and

License

16. Arms Act, 1950. (if guards have weapons)17. Boilers Act, 1923.18. Cable television networks Act, 1995.19. Central sales tax Act, 1956.20. Consumer protection Act, 1986.21. Contract Act, 1982.22. Copyright Act, 1982.23. Customs Act, 1962.24. Dentist regulations, 1976.25. Drugs and cosmetics Act, 1940.26. Electricity Act, 1998.27. Electricity rules, 1956.28. Employees provident fund Act, 1952.29. ESI Act, 1948.30. Employment exchange Act, 1969.31. Environment protection Act, 1986.

32. Equal remuneration Act, 1976.33. Explosives Act, 1884.34. Fatal accidents Act, 1855.35. Gift tax Act, 1958.36. Hire Purchase Act, 1972.37. Income Tax Act, 1961.38. Indian Lunacy Act, 1912.39. Indian Medical Council Act and Code of Medical Ethics, 1956.40. Indian Nursing council Act, 1947.41. Indian penal code, 1860.42. Indian trade unions Act, 1926.43. Industrial disputes Act, 1947.44. Insecticides Act, 1968.45. Lepers Act46. Maternity benefit Act, 1961.47. MTP Act, 1971.

48. Minimum wages Act, 1948.49. National building code.50. National holidays under shops Act.51. Negotiable instruments Act, 1881.52. Payment of bonus Act, 1965.53. Payment of gratuity Act, 1972.54. Payment of wages Act, 1936.55. Persons with disability Act, 1995.56. Pharmacy Act, 1948.57. PNDT Act, 1996.58. Prevention of food adulteration Act, 1954.59. Protection of human rights Act, 1993.60. PPF Act, 1968.61. Registration of births and deaths Act, 1969.62 .Sale of goods Act, 1930.63.Tax deducted at source Act.64. Sales tax Act.65. SC and ST Act, 1989

66. License for the blood bank67. Companies Act, 195668. Constitution of India69. Insurance Act, 193870. Transplantation of human organs Act 1994 and License (if applicable)71. Workers compensation Act, 192372. Urban land Act, 1976

Bhore committee 1946 Comprehensive and structured

Mudaliar Committee 1961 public health act Control and standardisation of institutions

including pvt hospitalsMukherjee committee 1966 health servicesAjith Prasad jain committee 1968 on

hospitalsICMR/ICSSR Committee 1981

comprehensively review health & healthcare situation

Working group of planning commission 1989 on ISM and Homoeopathy

MAJOR COMMITTEES

Varadappan committee 1989 NursingCommittee on Subordinate legislation 10th

Loksabha 1991 -1996Comprehensive recommendations

Major committees contd.

FEBRUARY , MARCH data collection, research, consultationsAPRIL meetingsMAY – JULY Campaigning, political lobbying, legal fightAUG – OCT Follow up activities and meetingsNOV Summing up

SCHEDULE OF ACTIVITIES 2015

THANK YOU