Medical Law and Ethics

Describes Functions of IMC, SMC, NMC, Professional Misconduct, Rights and Duties of a Doctor, Professional Secrecy, Privilidged Communication, Professional Medical Negligence, consent and its types, Consumer Protection Act

1. MEDICAL LAW AND ETHICS -Dr. Divya Reddy, Assistant Professor, Dept. of Forensic Medicine and Toxicology, RVMIMS 1

2. DEFINITIONS Medical ethics - the moral principles which should guide the members of the medical profession in their dealings with each other, their patients and the state. 2

3. DEFINITIONS Medical etiquette - Conventional laws of courtesy observed between members of the medical profession 3

4. INDIAN MEDICAL COUNCIL ACT 1956 The medical council was constituted by the act The first schedule of the Act – Recognized Medical qualifications granted by Universities in India The second schedule – those granted outside India The Third schedule – Part I: Contains those granted by medical institutions not included in the first schedule Part II: contains those granted outside India, but not included in second schedule 4

5. INDIAN MEDICAL COUNCIL (MCI) Medical register Medical education Recognition of foreign medical qualifications Appeal against disciplinary actions (within 30 days) Warning notice 5

6. REGISTRATION CERTIFICATE OF MCI 6

7. NATIONAL MEDICAL COMMISSION National Medical Commission Bill proposes to replace the Medical Council of India (MCI) with National Medical Commission which will be a central authority that will responsible for regulating medical education in the country. Four autonomous boards. Each board will consists of President and four members of which two members will be part time and they are appointed by the central government on the recommendation of a search committee. 7

8. NATIONAL MEDICAL COMMISSION These bodies are: The Under-Graduate Medical Education Board (UGMEB) The Post-Graduate Medical Education Board (PGMEB) The Medical Assessment and Rating Board: This board will be responsible to levy monetary penalties on institutions which fail to maintain the minimum standards. The Ethics and Medical Registration Board. A person who is aggrieved by any decision made by autonomous board may appeal to commission within 60 days 8

9. FUNCTIONS OF NATIONAL MEDICAL COUNCIL To lay down the policies for regulating medical institutions and medical professionals. To assess the requirements of human resources and infrastructure in healthcare. To ensure compliance by the State Medical Councils with the regulations made under the NMC bill. To frame guidelines for determination of fee up to 50% of the seats in the private medical institutions. 9

10. MEDICAL ADVISORY COUNCIL Primary platform through which the states and union territories may put forward their concerns before NMC They shall advise the NMC on measures to maintain minimum standards in medical education, training and research 10

11. STATE MEDICAL COUNCIL Medical register Disciplinary Control Warning notice 11

12. WARNING NOTICE RMP is required to observe certain prescribed rules of the conduct Gives list of examples of offences which constitute serious professional misconduct It has the right to consider any new forms of alleged misconduct not included in the list PERMANENT PENAL ERASURE/ PROFESSIONAL DEATH SENTENCE : Name of the practitioner is removed from the register in serious professional misconduct permanently . 12

13. DISCIPLINARY ACTION BY SMC 13

14. INFAMOUS CONDUCT Syn : Professional Misconduct Conduct of the doctor which might reasonably be regarded as disgraceful & dishonorable which is judged by professional men of good repute & competence It involves an abuse of professional position 14

15. 6 ‘A’s Adultery Advertisement Abortion (criminal) Association with unqualified persons in professional matters Alcohol Addiction INFAMOUS CONDUCT 15

16. Dichotomy Touts Professional secrets Conviction- immoral & criminal acts Not notifying notifiable diseases Refusing Rx- on basis of caste, religion, race, sex, nationality, some diseases (A.I.D.S False/misleading certificates INFAMOUS CONDUCT 16

17. Refusing to Rx emergency cases Abuse of dangerous drugs act/scheduled drugs act. Owning a chemist shop/ surgicals Adopting unfair means Secret remedies Patient snatching Association with unqualified people - Violation of PNDT (prohibition of sex selection) Act 1994 INFAMOUS CONDUCT 17

18. Abetting / aiding in torture/human rights violation Publish photos/case reports Failure to obtain consent- both spouses in sterilization / in vitro fertilization Violating I.C.M.R. guidelines in clinical drugs trails or other research Euthanasia INFAMOUS CONDUCT 18

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22. RED CROSS EMBLEM The emblems of the International Red Cross and Red Crescent Movement, under the Geneva Conventions, are to be placed on humanitarian and medical vehicles and buildings. Wrong belief that doctors are entitled to use it Section 12 – Geneva convention act 1960 prohibits its use. Section 13 – punishment – fine upto Rs.500 and forfeiture of goods present in the vehicle 22

23. RED CROSS EMBLEM 23

24. RIGHTS OF A REGISTERED MEDICAL PRACTITIONER To practice medicine To choose a patient To dispense medicine To posses & supply dangerous drugs To add title, descriptions etc to the name To recover fees 24

25. RIGHTS OF A REGISTERED MEDICAL PRACTITIONER Appointment to government & public hospitals To issue medical certificates To give evidence as expert witness Entitled to carry out medico-legal autopsies Can remove cornea/eyes of a deceased person. 25

26. DUTIES OF A REGISTERED MEDICAL PRACTITIONER To exercise reasonable degree of skill, care& knowledge during treatment Attendance & examination To furnish proper & suitable medicines To give instructions To execute humanitarian duty in emergencies. To control & warn - Regarding notifiable diseases To inform & warn third parties - Children & adults who are incapable To inform about risks - regard to poisons and operations 26

27. DUTIES OF A REGISTERED MEDICAL PRACTITIONER – MLC CASES Inform police in all Medicolegal cases Arrange for taking dying declaration Should keep medical records for a period of 10 years Should maintain professional secrecy Should issue medical records within 72 hours Should maintain a registry for MLC cases 27

28. PROFESSIONAL SECRECY Implied term of contract between doctor and the patient. If the disclosure did some harm to the patient, he can sue the doctor for damages Should not be discussed even with spouse if it is not a communicable disease Examination of insurance is voluntary and can be revealed to company Information found during autopsy should not be revealed to public without consent from relatives 28

29. PRIVILEGED COMMUNICATION It’s a statement made bonafide upon any subject matter by a doctor to the concerned authority, due to his duty to protect the interests of the community or of the state. It should be unbiased, bonafide & without any malice 29

30. Infectious diseases Venereal diseases Notifiable diseases Suspected crime Self interest Patients own interest Negligence suits Courts of law Insurance reports EXAMPLES FOR PRIVILEGED COMMUNICATION 30

31. PROFESSIONAL NEGLIGENCE Absence of reasonable care & skill Willful negligence of a medical practitioner in the treatment of a patient; which may cause bodily injury or death of the patient 4 ESSENTIAL INGREDIENTS: Duty Dereliction of Duty Direct Causation Damage Burden of proof lies on the patient 31

32. TYPES OF PROFESSIONAL NEGLIGENCE Civil negligence Criminal negligence Contributory Negligence Corporate Negligence Composite Negligence 32

33. CIVIL NEGLIGENCE Simple absence of care & skill This question arises when: Patient/relative brings a civil suit against doctor When a doctor brings a civil suit for realization of fees against the patient 33

34. CIVIL NEGLIGENCE Damage may be in the form of: Physical & mental suffering Prolongation of hospital stay - Increased expenses - Loss of daily earnings Reduction in enjoyment Reduction in life expectancy Death 34

35. EXAMPLES Failure to obtain consent Wrong diagnosis due to absence of care & skill Failure to attend / make alternative arrangements No proper instructions/post-op care Failure to immunize/perform sensitivity tests If the act of the doctor causes others to catch a disease from his patients Discharging patient prematurely Not advising X-ray/F.N.A.C/biopsy or other necessary investigations Not advising consultation when required 35

36. CRIMINAL NEGLIGENCE Gross lack of competence Gross inattention Gross recklessness Gross negligence in the selection & application of remedies Willful/wanted Extreme departure from the ordinary standard of care Utter disregard about the safety of the patient 36

37. CRIMINAL NEGLIGENCE 37

38. Imprisonment with or without fine If the patient dies the doctor will be prosecuted u/s 304(A) I.P.C “ Whoever causes death of any person by any rash & negligent act not amounting to culpable homicide shall be punished with imprisonment up to 2 years with or without fine” Sec 336 IPC: If no injury has occurred but the doctor endangered the life of the patient Sec 337 IPC: If hurt was caused Sec 338 IPC: If grievous hurt was caused CRIMINAL NEGLIGENCE 38

39. EXAMPLES Amputation of wrong part or wrong patient Leaving behind instruments, sponges/swabs etc Gross mismanagement of a delivery case Administration of wrong substance to eye Performing criminal abortion 39

40. PROFESSIONAL NEGLIGENCE VS PROFESSIONAL MISCONDUCT 40

41. CIVIL VS CRIMINAL NEGLIGENCE 41

42. RES IPSA LOQUITUR The thing speaks for itself Doctrine of Common Knowledge Patient need not prove that negligence has occurred. Pre-requisites: In the absence of negligence the injury/damage would not have occurred ordinarily The doctor had exclusive control over injury producing instrument or treatment Patient was not guilty of contributory negligence 42

43. RES IPSA LOQUITUR 43

44. DEFENCES AGAINST MEDICAL NEGLIGENCE Calculated risk doctrine Contributory negligence Vicarious Liability Novus Actus Interveniens Corporate Negligence Products Liability Medical Mal occurrence Therapeutic Misadventure Error in Judgment Res Indicata Res Judicata Composite Negligence 44

45. CALCULATED RISK DOCTRINE In certain management maneuvers there may be certain amount of inevitable risk Amniocentesis- 1% risk of abortion C-Section – 0.1% risk of maternal mortality Doctor must give: 1. Justification for risk taken 2. Preventive measures taken 45

46. CONTRIBUTORY NEGLIGENCE Concurrent negligence/unreasonable conduct on the part of the patient/attendant which coupled with doctor’s negligence caused the damage; with out which the injury would not have occurred. Failure to give accurate history Failure to co-operate with the doctor in carrying out all reasonable & proper instructions Failure to take suggested treatment Discharge Against Medical Advice Neglecting follow-up 46

47. Good defence in civil cases Only a partial defence Limitations : The last clear chance doctrine The avoidable consequences rule CONTRIBUTORY NEGLIGENCE 47

48. VICARIOUS LIABILITY “An employer is responsible not only for his own negligence but also for the negligence of his employees”. Principle: Respondent superior (let the master answer) Pre-requisites: Employer-Employee relationship must be established Employees conduct must occur within the scope of employment Negligence should occur while on job 48

49. Borrowed servant doctrine – New employer responsible An employee may serve more than one employer Junior doctor/intern Nursing staff Pharmacist Usually surgeon not responsible for negligence of anesthetist & vice-versa VICARIOUS LIABILITY 49

50. NOVUS ACTUS INTERVENIENS 50 “An unrelated action intervening” A person is not only responsible for his actions, but also for the logical consequences of those actions An element of negligence is essential

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52. CORPORATE NEGLIGENCE Failure of the administrators of the hospital to provide adequate facilities Hospital administrators should provide standard equipments and component employees 52

53. PRODUCTS LIABILITY Physical agent which caused the injury or death of the patient during treatment Faulty, defective, negligently designed instruments or inadequate operating instructions- fault of manufacturer If it functioned satisfactorily for many years, later due to wear & tear or if not handled properly – doctor is at fault 53

54. MEDICAL MALOCCURANCE Bio-physiological actions & reactions to different drugs are different & extremely variable. Tolerance Idiosyncrasy Must be aware of unexpected, unexplained &even rare effects Not a blank cheque 54

55. MISADVENTURE Therapeutic misadventure Penicillin Anti snake venom Anti cancer drugs Diagnostic Barium enema - poisoning / rupture Experimental 55

56. ERROR IN JUDGEMENT Only because of error in judgment, a doctor cannot be held negligent if he has executed proper skill and care 56

57. Damage has occurred to the patient due to negligence of two or more persons and not from the part of the patient Compensation should be split between the defendant COMPOSITE NEGLIGENCE 57

58. RES INDICATA A case should be filed within 2 years from the date of alleged negligence. 58

59. Things have been decided Once a case is completed between two parties, it cannot be tried again RES JUDICATA 59

60. PRECAUTIONS TO AVOID NEGLIGENCE Communication: Be polite, establish good rapport NEVER guarantee cure but care Prognosis: no exaggeration Give proper & clear instructions - prescriptions - diet - pre- op instructions - use of inhalers 60

61. PRECAUTIONS TO AVOID NEGLIGENCE Case records Up-to-date, accurate & complete Patient refusing any particular treatment, investigation Discharge against medical advice Consent: own handwriting if literate 61

62. PRECAUTIONS TO AVOID NEGLIGENCE Update knowledge M.C.I stipulates 30 hrs of C.M.E. in five years Must keep abreast with the latest developments Always practice standard procedure of Rx -never experiment. 62

63. Do not neglect the patient Reasonable degree of care & skill Attend regularly All necessary investigations Consultation if required Arrange for a good substitute PRECAUTIONS TO AVOID NEGLIGENCE 63

64. Do not criticize another doctor Associate with good & qualified staff Cordial working atmosphere Guard against hazards-Adverse drug reactions Instruments, equipments etc should be well maintained – serviced regularly, repaired or replaced PRECAUTIONS TO AVOID NEGLIGENCE 64

65. MEDICAL INDEMNITY INSURANCE Contract between insurance company and the doctor to compensate in professional negligence Objectives: To protect Professional interest of doctors To pay for the conduct of defence of doctor in medical negligence To compensate the amount the court declares to the opposite party 65

66. CONSENT 66 Means voluntary agreement, compliance or permission. Types: Expressed Verbal Written Implied

67. INFORMED WRITTEN CONSENT 67 Consent given after understanding the result, nature and quality of all possible risks involved as well as having alternate choice. Doctor Should explain: Diagnosis Proposed line of Rx Alternatives available Pros & cons Relative chances of success /failure Consequences of refusing Rx

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69. EXCEPTIONS FOR INFORMED CONSENT 69 Therapeutic Privilege Emergency Doctrine Therapeutic Wavier Loco Parentis

70. THERAPEUTIC PRIVILEGE 70 Privilege to withhold from patient, if disclosure would cause serious psychological threat to the patient Eg : Malignancy Should be informed to relatives and written consent should be obtained from them.

71. EMERGENCY DOCTRINE 71 In an emergency doctor can perform surgery on an unconscious patient, when no guardian or parent is available. Necessary to save life 92 IPC – Any harm caused to a person in good faith, even without consent is not an offence if the situation is such that it is impossible for that person to give consent & has no guardian or other person in lawful charge of him

72. THERAPEUTIC WAVIER 72 In emergency situation, competent person may give up his right by waving it.

73. LOCO PARENTIS 73 In place of a parent In emergencies involving children, when their parents or guardian are not available, consent can be taken from person who is in charge of the child. Eg : teacher or principal of residential school

74. RULES OF CONSENT 74 Needed for every medical examination If implied no need of formal consent Oral consent-presence of III party beyond routine physical examination – written consent No prescribed Proforma –should be in a proper form & suitable for the situation Not to be taken at the time of admission but before the procedure/examination To be valid- no blanket consent Victim exam – consent must

75. 75 Questionable legal validity

76. SECTIONS 76 53(a) CrPC : accused examination even without consent by the request of SI 53 (b) CrPC – when the accused happens to be a women 54 CrPC – arrested person requesting to be examined to collect evidence in his favor 87 IPC - > 18yrs –valid consent to suffer any harm which may result from an act not intended or not known to death or grievous hurt 88 IPC – done in good faith and for his benefit - Children < 12yrs & an insane person cannot give valid consent 89 IPC – Parent/guardian’s consent - Loco parentis

77. SECTIONS 77 90 IPC– consent given under fear of injury or due to misunderstanding consent by an insane/intoxicated who is unable to understand the nature & consequences of the act 92 IPC – Any harm caused to a person in good faith, even without consent is not an offence if the situation is such that it is impossible for that person to give consent & has no guardian or other person in lawful charge of him from whom it is possible to obtain consent in time to do the act for his benefit

78. CONSENT 78 Open consent- in case where diagnosis is not known. Consent of hostel inmates Vaccination- Law gives consent A person can be treated with out consent for the benefit of the society Consent given for committing a crime like criminal abortion – invalid For contraceptive sterilization, consent of both Husband & Wife

79. CONSENT 79 In other types of operation the consent of other spouse is not needed - But it is advisable: - danger to life - may destroy / limit sexual function - may cause death of unborn child Unlawful to detain any patient Donating organs Clinical autopsy Defence in civil negligence

80. CONSUMER PROTECTION ACT 1986 80 Purpose To protect the interest of consumers Includes services like, household articles, banking, food, transport, entertainment, electricity etc. Medical profession - included in 1995 Aims to provide cheap & speedy remedy Criticism: Defensive medicine Indemnity insurance Frivolous complaints District forum < 20 lakhs ; State commission >20 lakhs ; < 1crore; National commission > 1crore Doctors are excluded in the latest CP Bill 2019.

81. CONSUMER PROTECTION BILL 2019 81

82. WORKMEN’S COMPENSATION ACT 1923 82 For providing compensation to workmen for injuries sustained in workplace or diseases contracted by them Schedule I – gives list of disabilities due to injuries and their percentage Schedule III – Occupational diseases and industrial poisons Not liable for compensation if at the time of sustaining injury he was under the influence of alcohol. RMP issues injury certificate in such cases

83. TRANSPLANTATION OF HUMAN ORGANS ACT 1994; UPDATED 2012 83 The Transplantation of Human Organs Act provides for the regulation of the removal, storage, and transplantation of human organs for therapeutic purpose and for prevention of Commercial dealings of human organs. Organs that can be transplanted are – the heart, kidneys, eyes, liver, lungs, pancreas, intestine, and thymus. Tissues include bones, tendons cornea, skin, heart valves, and veins. Worldwide, the kidneys are the most commonly transplanted organs, followed closely by the liver and then the heart.

84. 84 Section 3 – Any donor may prescribe, authorize the removal, before his death, of any human organ of his body for therapeutic purposes Where no such authority was made by any person before his death but no objection was also expressed by such person for therapeutic purposes where brain- stem death of any person, less than eighteen years of age, occurs and is certified, any of the parents may give authority for the removal TRANSPLANTATION OF HUMAN ORGANS ACT 1994; UPDATED 2012

85. 85 Section 4: Removal of human organs not to be authorized in certain cases. Section 5: Authority for removal of human organs in case of unclaimed bodies in hospital or prison. Section 6: Authority for removal of human organs from bodies sent for PME. Section 7: Preservation of human organs Section 8:  Restrictions on removal and transplantation of human organs TRANSPLANTATION OF HUMAN ORGANS ACT 1994; UPDATED 2012

86. 86 Section 10: Regulation of hospitals conducting the removal, storage or transplantation of human organs.- Section 11:  Prohibition of removal or transplantation of human organs for any purpose other than therapeutic purposes Section 12: Explaining effects, etc., to donor and recipient.  Section 13:  Appropriate Authority Section 14: Registration of hospital engaged in removal, storage or transplantation of human organs Section 16: Suspension or cancellation of registration TRANSPLANTATION OF HUMAN ORGANS ACT 1994; UPDATED 2012

87. 87 SECTION 18:  PUNISHMENT FOR REMOVAL OF HUMAN ORGAN WITHOUT AUTHORITY- Any person helps in any manner in the removal of any human organ without authority – shall be punishable with imprisonment may extend to five years and with fine Where any person convicted is a registered medical practitioner, – his name shall be reported by the Appropriate Authority to the respective State Medical Council for taking necessary action including the removal of his name from the register of the Council for a period of two years for the first offence and permanently for the subsequent offence. TRANSPLANTATION OF HUMAN ORGANS ACT 1994; UPDATED 2012

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