transplantation of human organs and tissues act and its amendments

1. THE TRANSPLANTATION OF
HUMAN ORGANS ACT, 1994
AND IT’S AMMENDMENTS

2. THOA IN A GLANCE
 An Act to provide for the regulation of removal, storage and transplantation of human
organs for therapeutic purposes and for the prevention of commercial dealings in human
organs and for matters connected therewith or incidental thereto.

3.  Heart
 Kidney
 Liver
 Lungs
 Pancreas
 Intestine
 Thymus
 Tissue (include bones, tendons, cornea, skin, heart valves, nerves and veins)

4. • Eyes Act of 1982 and Ear Drums and Ear Bones Act of 1982 (Union Territory of Delhi)
• Maharashtra Kidney Transplantation Act 1982 and Bombay Corneal Grafting Act,1957
• Transplantation of Human Organs Bill, 1992 was Introduced in Lok Sabha on 20 August
1992.
• This Bill was assented by the President on 08 July 1994.
• It became ‘The Transplantation of Human Organs Act’, 1994.

5.  Donor –means a person , not less than 18 years of age, who voluntarily authorizes
removal of any of his organs for therapeutic purposes.
 Hospital – Nursing Home, Clinic, Medical Centre, medical or teaching institution for
therapeutic purposes.
 Near Relative – Spouse, Son, Daughter, Father, Mother, Brother, Sister.
 Registered Medical Practioner – means a Medical Practioner who possesses any
recognized medical qualifications as defined in Clause (H) of section 2 of the Indian
Medical Council Act, 1956 (102 of 1956) and is enrolled on a State Medical Council.

6. For living donation –
 It defines who can donate without any legal formalities. The relatives who are allowed to
donate include mother, father, brothers, sisters, son, daughter, and spouse. Recently, in the
new Gazette grandparents have been included in the list of first relatives. The first
relatives are required to provide proof of their relationship by genetic testing and/or by
legal documents.

7.  In the event of there being no first relatives, the recipient and donor are required to
seek special permission from the government appointed authorization committee and
appear for an interview in front of the committee to prove that the motive of donation
is purely out of altruism or affection for the recipient.

8. Brain death is defined by the following criteria:
 Two certifications are required apart from doctors and two of these have to be doctors
nominated by the appropriate authority of the government with one of the two being an
expert in the field of neurology.

9.  1) Any donor can authorize the removal, before his death, of any human organs of his
body for therapeutic purposes.
 2) Any donor in writing in presence of two or more witness authorized at any time before
his death, the removal of his organs after his death for therapeutic purpose.
 3) If any near relative of deceased person has no objection for removal of his organ for
therapeutic purpose.
 4) Authority is given to registered medical practitioner.

10.  Regulation of transplant activities by forming an Authorization Committee (AC) and
Appropriate Authority (AA.) in each State or Union Territory.

11.  The state level committees shall be formed for the purpose of providing approval or no
objection certificate to the respective donor and recipient to establish the legal and
residential status as a domicile state. It is mandatory that if donor, recipient and place of
transplantation are from different states, then the approval or no-objection certificate
from the respective domicile state government should be necessary. The institution
where the transplant is to be undertaken in such case the approval of authorisation
committee is mandatory.

12.  The quorum of the authorisation committee should be minimum four. however quorum
ought not to be considered as complete without the participation of the chairman. The
presence of secretary (health) or nominee and director of health services or nominee is
mandatory.

13. • Central Govt. shall appoint ,by notification, one or more officers as AA, and State Govt. for
the State.

14.  To grant registration to a hospital for the removal, storage and transplantation of any
human organ.
 To suspend or cancel such registration.
 To enforce standards for hospitals engaged in the removal/ storage or transplantation of
human organs.

15.  To investigate any complaint or breach of any provision of the Act or the Rules.
 To inspect hospitals periodically for examination of the quality of transplantation and
follow-up medical care to the recipients as well as donors.
 Power to summon persons, seek production of documents, issue search warrants.

16. Regulation of hospital conducting the removal, storage or transplantation of human organs:
1) No hospital shall commence any activity relating to removal, storage or transplantation
of any human organ unless it is registered under this act.
2) No medical practitioner or any other person shall conduct or aid in conducting removal,
storage or transplantation of any human organ at place other than registered.

17. Prohibition of removal or transplantation of human organs for any purpose other than
therapeutic purpose:
 No person & no donor give authority for transplantation of organ for any purpose other
than therapeutic.
 Explaining ,effects etc, to donor & recipient:
 No registered medical practitioner shall undertake removal or transplantation unless he
has explained prescribed manner, all possible effect & complications to donor & recipient
respectively.

18.  No hospital shall commence any activity relating to removal, storage or transplantation of
any human organ unless it is registered under.
Certificate of registration:
 Appropriate authority shall grant certificate to hospital such from, for such period &
subject to such conditions.
 Every certificate of registration shall be renewed such manner & on payment of fees as
prescribed.

19.  Imprisonment for term which may extend to 5yrs fine up to 10,000 or more.
 If a person is registered medical council for taking necessary action including removal of
his name from council for period of 2yrs first offence and permanently for the
subsequent offence.

20.  Makes or receives any payment for the supply of or for an offer to supply any human
organs.
 Seeks to find a person willing to supply any human organ for payment
 Offers to supply any organ for payment.
 Initiates or negotiates any arrangement involving the making of any payment for supply
of human organs
 Takes part in management or control of body of persons, either a society, firm or company
in initiation or negotiation any arrangement making of any payment for supply of human
organ.
 Publishes or distributes any advertisement.
 Inviting persons to supply for payment of any human organ.

21.  Imprisonment for term which may extend to 2yrs to 5years fine up to 10,000 to 20,000
rupees.
 If any contravenes ,Imprisonment for term which may extend to 3yrs fine up to 10,000
or more.
 The offence has been committed with the consent or connivance of, or is attributable to
any neglect on the part of, any director, manager, secretary or other officer of the
company, such director, manager, secretary or other officer shall also be deemed to be
guilty of that offence and shall be liable to be proceeded against and punished
accordingly.

23.  THO Act to cover both organs & tissues.
 These rules may be called the Transplantation of Human Organs and Tissues Rules, 2014.
 Hospital with adequate ICU facilities, but not registered under the THO Act
 Hospital registered under the THO Act
 Transplant Coordinator, A person appointed by a hospital to coordinate all matters
relating to removal or transplantation of human organs/tissues

24. Duties of the registered medical practitioner
 Mandatory for ICU doctor, in consultation with transplant coordinator to request relatives
of brain dead patients for organ donation.
 The registered medical practitioner (RMP)shall before removing any human organ
and/or tissue from the body of a donor before his/her death, shall satisfy himself
-The donor has given his/her authorization appropriate form 1(a) or 1(b) or 1(c).
AUTHORISATION COMMITTEE
Foreign nationals
 Authorization committee to prohibit organ transplantation where recipient is a foreign
national and donor is an Indian national.
 Approval of authorization committee required - donor and / or recipient being near
relatives are foreign nationals.
Mentally challenged
 No human organ or tissue to be removed from the body of a mentally challenged person
before his death for the purpose of transplantation.

25. SWAP DONATIONS
 Two different willing but incompatible ‘near relative’ donors (vis-à-vis their intended
related recipient) permitted to donate their organs.
 Authorization committee will evaluate on a case-to-case basis.

26. Application for live donor transplantation
 “Authorization committee” as specified in form 10
 The guidelines in rule 6-F
Composition of authorization committees
 A. There shall be one State level Authorization Committee.
 B. Composition of hospital based authorization committees.
 C. Composition of state or district level authorization committees.

27.  The appropriate authority as specified in form 11 or 11A or 11B.
 1000rs fees payable at bank draft or postal order
 Grant a certificate of registration as specified in form 12 and it shall be valid for a period
of five years from the date of its issue and shall be renewable.
 Mandatory for the hospital to nominate a transplant coordinator.

28.  A period of three months prior to the date of expiry.
 A fee of rupees five thousand payable to the appropriate authority by means of a bank.
 A renewal certificate of registration shall be as specified in Form 13 and shall be valid for
a period of five years.

29.  1.General Manpower Requirement Specialised Services and Facilities(24hr ICU, NURSE, DR
& LAB ETC)
 2.Equipment.
 3.Experts and their qualifications
 a. Kidney transplantation: (M.S. (Gen.) Surgery )
 b. Transplantation of liver and other abdominal organs
 c. Cardiac, pulmonary, cardio-pulmonary transplantation.(M.Ch. Cardio-thoracic and
vascular surgery )
 d. Cornea Transplantation(MS /MD OPTHO)
 e. Other Tissues: Heart Valves, Skin, Bone etc.

30. Transplant coordinator – qualification
 Graduate of any recognized system of medicine
 Nurse, as defined in the Indian Nursing Council Act
 Master’s degree in Public Health/Social Work/Psychology
 Qualified counselor
Role of Advisory committee.
Information to be included in national registry regarding donors and recipients of human
organ and tissue.
Power to amend the rules:
 Central government

31.  Life long free renal / liver checkup, follow-up and care in hospital, (including its other
branches, if any), where organ donation has taken place.
 To secure the donor against mortality risk due to organ donation related reasons, a
customized life insurance policy of Rs. 2 Lakhs for 3 years with one time premium to be
paid by recipient.
 Certificate of appreciation to all live donors by state/local government with an identity
card.
• Endorsing his eligibility to obtain and avail various benefits recommended here. The card
should prominently display a slogan such as “thank you for saving a life”.
• Compensation for any expenses / loss of income incurred as specified in section 2 (k) of
the THOA act.
• 50% concession in 2nd class by Indian railways.

32.  NMC NOIDA IN 1998 – Kidney Transplantation Racket.
 KAKKAR HOSPITAL, AMRITSAR – Kidney Transplantation Racket.
 Kidney Transplantation Racket in five Hospitals of Hyderabad In 1993.

34. CONSTRAINTS ON IMPLEMENTATION
“We too are human beings and we cannot easily say ‘no’ to applicants seeking our
approval for receiving unrelated kidneys, even when we strongly suspect monetary
transactions between them. It is very difficult to disapprove them especially when they
are in tears crying for our help and have been suffering from want of a kidney for several
months. We tend to give in especially when patients undergo transplant surgery for the
second time, which is not uncommon.’”
(FORMER GOVT OFFICIAL)

35. Summing up, commercialization is widely acknowledged to exist.
Factors that explain failure of THOA
 Key commercial interests (notably middlemen/brokers and service providers)
 The ambiguities and loopholes in the act.

36. ETHICS
“ Ethics does not treat the world. Ethics must be a condition of the world, like logic.”
Wittgenstein
Ethical issues related to the donor’s family.
• Relation between brain death & organ donation.
• Decision maker in the family.
• Incentives
• Religious issues
• Medico-legal case
• Conditions / choice regarding recepients.

37.  Internet Soliciting
 Different Sources of Organs
 “Organ Market”: Impact On Cadaver Transplant.

38.  No actual penalization of people involved in organ rackets till date.
 Allows brain death to be recognized in only selected recognized organizations.

39.  No matter what the situation, the solutions proposed, “the
dignity of the living & the dying remains at stake & must be
factored into the equation.”

40.  Xeno-transplantation
 Cloning
 Developing artificial organs.
 Developing organs from patient’s stem cells.

41.  Role of media to increase awareness of organ donation.
 Promote organ donation in all communities.

42.  Counseling at hospital level.
 Approaching every brain dead patient.
 Multi-dimensional approach to meet physical, psychological, social
& spiritual needs.

43. What is truly distinctive about transplantation is not technology but
ethics. Transplantation is the only area in all health care that cannot exist
without the participation of the public. It is the individual citizen who
while alive or after death makes organs and tissues available for
transplantation. If there were no gifts of organs or tissues, transplantation
would come to a grinding halt.
Arthur Caplan,
Bioethicist

44. It is important for the psychosocial evaluation to include:
 Social, personal, housing, vocational, financial, and environmental support and strengths
 Identified and confirmed post transplant caregivers
 Post transplant medication plan
 Coping abilities and strategies
 Understanding of the risks and benefits of transplantation or live kidney donation
 Ability to adhere to a treatment regimen, and
 Mental health history, including substance or alcohol use and/or abuse and how it may
impact the success or failure of organ transplant or the safety of the living donor.

45. Psychosocial factors known to contribute to poor patient and donor.
 Poor social support/absence of family caregiver
 Mental/psychiatric disorders likely to negatively affect post transplant adherence
 Self-destructive behavior such as alcohol or substance abuse
 A history of poor adherence with medical and mental health treatment
 The patient’s inability or unwillingness to comprehend the need for improved adherence
 Dysfunctional personality traits and disorders, and
 Financial issues which could interfere with post-transplant medication adherence

46. Summing up..
Social workers are involved with transplant patients and living donors throughout the
transplant and donation process including pre-evaluation, psychosocial informed consent,
transplant and living donor selection, hospital discharge planning, and short term and long-
term follow up.
Social workers also provide counseling and crisis intervention, patient and family
education, information and referral to hospital and community resources and services,
facilitate patient and caregiver support groups and mentor programs.

49. World organ donation day
– August 13

50. Clarifications?