Download MBBS (Bachelor of Medicine, Bachelor of Surgery) 1st Year, 2nd Year, 3rd Year and Final year Surgery 44 Organ Transplantation PPT-Powerpoint Presentations and lecture notes
THE TRANSPLANTATION OF
HUMAN ORGANS ACT, 1994
Dept of Surgery
PREDECESSORS
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 Bil , 1992 was
Introduced in Lok Sabha on 20 August 1992.
This Bil was assented by the President on 08 July
1994.
It became `The Transplantation of Human Organs
Act',1994(42 of 1994).
Donor ?means a person , not less than 18 years of age,
who voluntarily authorises 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, 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 enrol ed on a State Medical Council.
BOARD OF MEDICAL EXPERTS
Registered Medical Practioner, in charge of the
hospital in which brain-stem death occurred
An independent RMP, being a specialist nominated by
the RMP in clause (I) from the panel of names
approved by appropriate authority
A neurologist or a neurosurgeon nominated by the
RMP in clause (I) from the panel of names approved
by appropriate authority
RMP treating the person whose brain-stem death has
occurred
_ _ _ _ _ _ _ _
No authority can be granted in cases an inquest is
required
In unclaimed bodies (more than 48 hours) in a hospital
or prison, the authority may be given by the person in
charge of management of the hospital or prison or a
person authorised in this behalf by the incharge
APPROPRIATE AUTHORITY
Central Govt. shal appoint ,by notification, one or
more officers as AA, and State Govt. for the
State.
Duties ?
To grant, renew, suspend and cancel registration
under sub-section(3) of that section.
To enforce standards as prescribed.
To investigate any breach of provisions of act.
To inspect hospitals for examination of the quality of
transplantation and fol ow-up care.
Registration of Hospitals ? apply to AA within
sixty days of commencement of Act
AA may reject the application, suspend or
cancel the Registration (with or without
notice)
Appeal within thirty days to Central/State
Govt against
Rejection/Suspension/Cancel ation
OFFENCES AND PENALTIES
Removal of organs without authority :
Imprisonment upto five years and fine of ten
thousand rupees
RMP ? Removal of name from register of State
Medical Council for two years for first offence and
permanently for subsequent offence
Punishment for commercial dealings in human organs ?
Imprisonment for a term between two to seven years
and a fine of between Rs. 10000-20000
THE TRANSPLANTATION OF HUMAN
ORGAN RULES 1995
DUTIES OF MEDICAL PRACTIONER ?
Authorization in Form no. 1 by donor
Medical fitness certificate (Form no. 2)
If donor is a near relative then Form no. 3 is fil ed
after establishing relation
If donor is spouse then sign a certificate in Form no.
4
Donor had authorised in presence of two witnesses
authorised removal of organ from his body,in Form No.
5
There is lawful possession of dead body by a person
having signed a certificate as specified in Form 6 or 7
Board of experts has signed Form 8
Form 9 has been signed by either of parents in case
the deceased is less than 18 years of age
Form 10 to be fil ed for transplantation by live donor
other than near relative, to be signed by both
prospective donor and recipient with reason of
affection and attachment. This has to be approved by
Authorisation Committee.
CONDITIONS FOR GRANT OF
CERTIFICATE OF REGISTRATION
GENERAL REQUIREMENT-
SURGICAL STAFF
CARDIOLOGY STAFF
NURSING STAFF
COMMUNICATION SYSTEM
INTENSIVIST
MEDICAL SOCIAL WORKER
PERFUSIONIST
OPHTHALMOLOGIST
NON TRANSPLANTATION PROGRAMME TEAM ?
NEUROLOGIST
NEUROSURGEON
MEDICAL SUPERINTENDENT
ANY OTHER HOSPITAL STAFF
EYE DONATION COUNSELLOR/GRIEF COUNSELLOR
CORNEAL SURGEONS
DEPARTMENTS ? 18 (Neurology,Microbiology,
Mycology,Pathology,Virology,Nephrology,
GI Surgery,Anaesthesiology,
Paediatrics,Physiotherapy,Immunology,Haematology,
Blood Bank, Imaging Services
ClinicalChemistry, Cardiology,Ophthalmology,Psychology)
BASIC EQUIPMENT ?
OPERATING ROOM FOR ROUTINE OPEN
HEART SURGERY WHICH INCLUDES HEART
LUNG MACHINE AND ACCESSORIES.
SLIT LAMP
SPECULAR MICROSCOPE
OPERATING MICROSCOPE
ADDITIONAL EQUIPMENT ?
CELL SAVER
ASSIST DEVICE LIKE IABP AND
CENTRIFUGAL PUMP
MOBILE C ARM
RADIOIMMUNOASSAY FOR MEASURING
CYCLOSPORIN LEVELS
LAB FACILITIES
AUTOCLAVE
UV LAMP
LAMINAR FLOW
RECENT ORGAN TRAFFICKING SCANDALS
NMC NOIDA IN 1998 ? Kidney Transplantation
Racket
KAKKAR HOSPITAL, AMRITSAR ? Kidney
Transplantation Racket
Kidney Transplantation Racket in five Hospitals of
Hyderabad In 1993
In USA, a total of 97,179 patients were waiting for
a transplant as of September 17, 2007. Fol owing is a
list by type of transplant needed:
73,149 patients waiting for a kidney transplant
16,702 patients waiting for a liver transplant
1,640 patients waiting for a pancreas transplant
2,316 patients waiting for a kidney-pancreas transplant
209 patients waiting for an intestine transplant
2,626 patients waiting for a heart transplant
115 patients waiting for a heart-lung transplant
2,336 patients waiting for a lung transplant
97,179 TOTAL PATIENTS
WAITING* * Some patients are waiting for more than
one organ, therefore, the total number of patients is
less than the sum of patients waiting for each organ.
Numbers of Transplants Performed During 2006
17,092 kidney transplants
6,650 liver transplants
463 pancreas transplants
954 kidney-pancreas transplants
175 intestine transplants
2,192 heart transplants
31 heart-lung transplants
1,405 lung transplants
28,932 TOTAL TRANSPLANTS PERFORMED*
? Based on data from the Organ Procurement and
Transplantation Network of the U.S. Department of
Health and Human Services, as of June 29, 2007 -- data
subject to change due to future submissions or
corrections.
THE REPORT
OF
TRANSPLANTATION OF HUMAN ORGANS ACT
REVIEW COMMITTEE
AS PER THE DELHI HIGH COURT JUDGEMENT
DATED 06.09.2004 IN W.P. NO.813/2004 TO
REVIEW THE PROVISIONS OF THE
TRANSPLANTATION OF HUMAN ORGANS ACT,
1994 AND THE TRANSPLANTATION OF HUMAN
ORGANS RULES,1995)
BACKGROUND
A committee, hereinafter referred to as the THOA
review committee, was constituted in terms of the
judgement dated September 6, 2004 passed by
Hon'ble Mr. Justice Manmohan Sarin of High Court of
Delhi in WP(c) 813/2004 titled Balbir Singh vs. The
Authorisation Committee and others (Balbir Singh
Case) with direction to review the efficacy, relevance
and impact of the legal provisions
Contained in the transplantation of human organs act,
1994 (TOHO Act) And The Transplantation Of Human
Organs Rules, 1994 (TOHO Rules).
The review committee commenced its working under
the chairpersonship of Additional Secretary (Health)
to the Government of India and set out to objectively
and critical y appraise and analyse the practical
functional y of the provisions of the TOHO act and
the TOHO rules, as defined by the Hon'ble High Court
of Delhi in the Balbir Singh case.
Make its recommendations on the
composition of Authorisation Committees
Jurisdiction of the Authorisation
Committees should be enlarged by
bringing within its ambit the process of
certifying a "near relative" or the task
be assigned to another designated
authority
Develop a mechanism where al proposed
donors including `near relatives' should be
scrutinised by a committee (The
Authorization Committee)
Composition of hospital based authorisation committees :
(to be proposed by institution and notified by govt.)
The senior most person officiating as medical director /
medical superintendent of the hospital.
DM/ADM/SDM of the district which include the
officers holding equivalent post in hierarchy
irrespective of nomenclature of the designation. (To be
nominated by concerned State/UT GOVT.)
Two senior medical practitioners from the same hospital
who are not part of the transplant team.
Two members being persons of high integrity, social
standing and credibility, who have served in high
ranking government positions, such as in higher
judiciary, senior cadre of police service or who have
served as a reader or professor in UGC approved
university or are self-employed professionals of repute
such as lawyers, chartered accountants, writers,
journalists and doctors (of Indian Medical Association)
etc.
One medical practitioner working in a government
hospital to be nominated by the Central/State
government.
Composition of state/ district level Authorisation
Committees (to be constituted by Concerned state/UT
govt.)
A medical practitioner officiating as chief medical
officer or any other equivalent post in the main/major
government hospital of the district.
DM/ADM/SDM Of the district which include
the officers holding equivalent post in hierarchy
irrespective of nomenclature of the designation.
Two senior medical practitioners to be chosen
from the pool of such medical practitioners who
are residing in the concerned district and who
are not part of any transplant team.
Two senior citizens, non-medical background
(one lady) of high reputation and integrity to be
chosen from the pool of such citizens residing
in the same district, who have served in
high ranking government positions, such as
in higher judiciary, senior cadre of police
service or who
have served as a Reader
or Professor in UGC approved University
or are self-employed professionals of
repute such as lawyers, chartered
accountants, writers, journalists and
doctors (of Indian Medical Association)
etc.
One medical practitioner working in a
government hospital to be nominated by
the concerned state/UT government.
ADDITIONAL FORMS
FORM 1A
FORM 1B
FORM 1C
FORM-2:AMENDED
FORM-4:DELETED
FORM-7:DELETED AS IT IS IDENTICAL TO FORM
6
FORM-10:AMENDED
Where the proposed transplant is between persons
related genetical y, (e.g. Brother, sister, mother, father,
children above the age of 18 years)
The Authorisation committee must evaluate:-
Results of tissue typing and other basic tests.
Documentary evidence of relationship e.g. Relevant birth
certificates and marriage certificate, certificate from
sub-divisional magistrate/ metropolitan magistrate/or
Sarpanch of the Panchayat;
Documentary evidence of identity and residence of the
proposed donor e.g. Ration card/voters identity
card/passport/ driving license/ pan card/bank account
and family photograph depicting the proposed donor and
the proposed recipient along with another near relative.
If in its opinion, the relationship is not conclusively
established after evaluating the above evidence, it may in
its discretion direct further medical tests as prescribed
in rule 4(1).
b) Where the proposed transplant is between a
married couple:
The authorisation committee must evaluate al
available evidence to establish the fact and
duration of marriage and ensure that
documents such as marriage certificate,
marriage Photograph is placed before the
committee along with the information on the
number and age of children and a family
photograph depicting the entire immediate
family, birth certificate of children containing
particulars of parents.
c) Where the proposed transplant is between persons
who are related genetical y but whose relationship
cannot be established in accordance with rules:-
Results of tissue typing and other tests with the name
of the HLA laboratory and if possible the statistical
estimation of the probability of a genetic relationship;
Documentary evidence of relationship
Ex. Relevant birth certificates and marriage
certificate,
certificate
from
sub-divisional
magistrate/ metropolitan magistrate/or Sarpanch of
the Panchayat; documentary evidence of identity and
residence of the proposed donor e.g. Ration
card/voters identity card/passport/ driving license/
pan card/bank account and family photograph
depicting the proposed donor and the proposed
recipient along with another near relative.
WHERE THE PROPOSED TRANSPLANT IS
BETWEEN INDIVIDUALS WHO ARE NOT
"NEAR RELATIVES"
The authorization committee must evaluate:-
That there is no commercial transaction between the
recipient and the donor. That no payment of money or
moneys worth as referred to in the sections of the act,
has been made to the donor or promised to be made to
the donor or any other person.
That the fol owing is specifical y assessed by the
authorisation committee :-
An explanation of the link between them and the
circumstances which led to the offer being made;
Reasons why the donor wishes to donate?
Documentary evidence of the link e.g. Proof that they
have lived together etc.
Old photographs showing the donor and the recipient
together.
That there is no middleman/tout involved;
That financial status of the donor and the recipient is
probed by asking them to give appropriate evidence of
their vocation and income for the previous three
financial years. Any gross disparity between the status
of the two, must be evaluated in the backdrop of the
objective of preventing commercial dealing.
That the donor is not a drug addict or a known person
with criminal record;
That the next of kin of the proposed unrelated
donor is interviewed regarding awareness
about his/her intention to donate an organ, the
authenticity of the link between the donor and
the recipient and the reasons for donation.
Any strong views/ disagreement/objection of
such kin may also be recorded and taken note
of.
E) When the proposed donor or the recipient or
both are foreigners:
A senior embassy official of the country of
origin has to certify the relationship between
the donor and the recipient or where they are
not related the reasons as to why the proposed
donor is desirous of donating his organ to the
proposed recipient.
Authorisation committee can examine the cases of
Indian donors consenting to donate organs to a foreign
national, including a foreign national of Indian origin,
with greater caution. This should be done rarely in
deserving cases only.
In case where the donor is a woman greater
precautions ought to be taken. Her identity and
independent consent should be confirmed/ verified by a
person other than the recipient. Any document with
regard to the proof of residence/ domicile and
particulars of parentage should be relatable to the
photo identity of the applicant in order to ensure that
the documents pertain to the same person, who is the
proposed donor and in the event of any inadequate or
doubtful information to this effect, the authorisation
committee may in its discretion seek such other
information or evidence as may be expedient and
desirable in the peculiar facts of the case.
In al cases of non-near relatives, the interview of the
donor should specifical y deal with the aspect of
affection/attachment/ other special reason, in order to
rule out commercial considerations.
Further al donors should specifical y be interviewed to
rule out any element of coercion, undue influence, fraud
or misrepresentation in the proposal of donation. The
authorization committee should state in writing its
reason for rejecting/approving the application of the
proposed donor and al approvals should be subject to
the fol owing conditions:-
That the approved proposed donor has been
and would mandatorily be subjected to al such
medical tests as required at the relevant
stages to determine his biological capacity and
compatibility to donate the organ in question
and further that the psychiatrist clearance
would also be mandatory to certify his mental
condition, awareness, absence of any overt or
latent psychiatric disease and ability to give
free consent. The committee also takes note of
the recent judgement of the Hon'ble Supreme
Court of India, where the "authorisation
committee" of Punjab was directed to examine
the donor and the recipient, while the
transplantation was to be carried out at
Chennai.
While an endeavour has been made to recommend the
enhanced jurisdiction of the authorisation committees
as envisaged in the judgement of Hon'ble Supreme Court
of India, yet it is felt that several aspects peculiar to
the attending ground realities were not brought to the
notice of the Hon'ble apex court. For instance what
happens if the donor and the recipient hail from
different states; what happens if one of them or both
hails from a state/states where there is/are no
"authorisation committee" and lastly it is not clear as to
whether the "authorisation committee" of the state
where transplantation is taking place, shal retain some
jurisdiction or wil be completely without jurisdiction
and if latter is the case then how wil the medical
evidence if required to be assessed, wil be assessed by
the domicile "authorisation committee" without
resulting in delays and without compromising the other
laudable objectives of the TOHO act.
Benefits for Live Donors
Comprehensive health care scheme may be evolved by
the government.
Life long free renal/liver checkup, fol ow-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 recepient.
Certificate of appreciation to al 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.
Recommended procedure for medical tests for
establishing genetic relationship between the recipient
and "near relatives" are as fol ows:-
The tests for HLA, HLA-B al eles to be performed by
the serological and/or PCR based DNA methods.
Test for HLA-DR beta genes to be performed using the
pcr based DNA methods.
Test for HLA-DR beta genes to be performed using the
PCR based DNA
? Methods where the above two tests does not
establish a genetic relationship between the donor
and the recipient, the same tests to be performed on
both or at least one parent. If parents are not
available, same tests to be performed on such
relatives of donor and recipient as are available and
are wil ing to be tested.
? Where the tests referred to above do not establish a
genetic relationship between the donor and the
recipient,
Tests for DNA fingerprinting using single
locus/multilocus polymorphic probes to be performed.
The head of the testing laboratory should state in
writing whether or not he/she is satisfied that the
claimed genetic relationship between the donor and the
recipient is established
Promote Swap Operations:
Swap operations that is to say that two different wil ing
but incompatible `near relative' donors (vis-?-vis their
intended related recipient) are permitted to donate
their organs in exchange without any commercial
interest and only due to the reason that despite
wil ingness, their organ was not found medical y
compatible for their intended recipients. This would
greatly help patients who have `near relatives' wil ing to
donate but incompatible for their recipient. Swap
operations may be considered by authorization
committee on case to case basis and as per the existing
THOA act and rules.
Unrelated donors can donate `by reason of affection or
attachment' towards the recipient (Ch 2, Sect 9(3))
This requires obtaining prior approval from an
authorising committee.
EFFECTIVENESS OF ACT
"THE ACT HAS BECOME USELESS BECAUSE
IT HAS NOT HELPED STOP THE
COMMERCIALISATION OF ORGAN
DONATION. IN FACT, IT HAS INCREASED
OVER THE RECENT PAST."
[NEPHROLOGIST]
"I RECEIVED SOME MONEY FROM THE
RECEPIENT FOR DONATING MY KIDNEY AND
I DONATED IT BECAUSE OF MONEY.'"
[DONOR]
CONSTRAINTS
ON
IMPLEMENTATION
COMMERCIAL INTERESTS (MIDDLEMEN AND
SERVICE PROVIDERS):
" I paid my broker his due as i was wheeled into the operation
theatre. He didn't move away from the stretcher until i paid
because he was not sure of me coming back alive. He made sure
of getting paid for arranging a donor for me."
(RECEPIENT)
`...It is possible for us to cut corners and lower the norms
required for performing transplantation....... The lack of
standards and economic pressures means that people will cut
corners.'
(NEPHROLOGIST)
CONSTRAINTS
ON
IMPLEMENTATION
AMBIGUITIES AND LOOPHOLES IN THE ACT
`I was asked to pose for a photograph with the recipient
and act as his wife for a while. I was told that this
arrangement wil help me in escaping the rules and
regulations and wil also expedite payments to me.'
(DONOR)
` My second daughter soon after her marriage was advised
to undergo transplant surgery. Although my first
daughter was wil ing to donate her kidney, her husband
demanded a sum of money ... I helped out with my own
savings and we paid nearly Rs 100,000 US $2,298;
1,890] to my first son-in-law.'
(MOTHER OF RECIPIENT)
CONSTRAINTS ON IMPLEMENTATION- LOW
MONITORING CAPACITY OF REGULATORY
AUTHORITIES
`I was asked by the recipient and the middleman to
report a wrong address to the ac to escape police
inquiries later.'
(DONOR)
... It is not possible for us to go on checking this as we
have a large number of such applications to scrutinise
Every week. As such, we have no mechanism to police
this practice and the rules as they exist do not require
of us such monitoring.'
(MEMBER OF AC)
CONSTRAINTS ON IMPLEMENTATION PRESSURES
AND RESPONSIBILITIES EXERTED ON THE ACS
Imagine you are in need of a kidney and have been waiting
for a year or so. This is a life and death situation. What
can you do if you don't find a related donor? Is it
correct to stop a donor from giving his/her organ, even
though he/she may receive some money in return for his
organ? Is it correct to stop a patient receiving an
unrelated kidney from a donor?'
(FORMER MEMBER OF AC)
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 especial y 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 especial y
when patients undergo transplant surgery for the second
time, which is not uncommon.'
(FORMER GOVT OFFICIAL)
Summing up, commercialisation 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,
The low monitoring capacity of regulatory authorities
The pressures and responsibilities exerted on the ACs
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.
ETHICAL ISSUES FACED AT THE HOSPITAL LEVEL
ROLE CLARIFICATION & AUTHORITY IN TEAM
PRESSURE FROM TRANSPLANT TEAM
COMFORTABILITY
FACTOR
IN
NON-
NEUROLOGISTS & SURGEONS.
RELATION BETWEEN BRAIN DEATH & ORGAN
DONATION.
LEGAL ASPECTS
No actual penalization of people involved in organ
rackets til date.
Al ows brain death to be recognized in only selected
recognized organizations.
GLOBAL ETHICAL ISSUES
INTERNET SOLICITING
DIFF. SOURCES OF ORGANS
"ORGAN MARKET": IMPACT ON CADAVER
TRANSPLANT.
RECOMMENDATIONS / POSSIBLE SOLUTIONS
NO MATTER WHAT THE SITUATION, THE
SOLUTIONS PROPOSED, "THE DIGNITY OF THE
LIVING & THE DYING REMAINS AT STAKE &
MUST BE FACTORED INTO THE EQUATION."
POSSIBLE BIOLOGICAL SOLUTIONS
XENO-TRANSPLANTATION
CLONING
DEVELOPING ARTIFICIAL ORGANS.
DEVELOPING ORGANS FROM PATIENT'S STEM
CELLS.
SOCIETAL / GLOBAL SOLUTIONS
ROLE OF MEDIA TO INCREASE AWARENESS OF
ORGAN DONATION.
PROMOTE ORGAN DONATION IN ALL
COMMUNITIES.
STATE LEVEL SOLUTIONS
REQUIRED CHANGES / MODIFICATIONS IN
EXISTING LAW IN INDIA.
CONSENT: INFORMED V/S PRESUMED.
MANDATED CHOICE OR REQUIRED RESPONSE
POLICY.
PROVISION OF REQUIRED FACILITIES.
INSTITUTIONAL LEVEL SOLUTIONS
COUNSELING AT HOSPITAL LEVEL.
APPROACHING EVERY BRAIN DEAD PATIENT.
MULTI-DIMENSIONAL APPROACH TO MEET
PHYSICAL,
PSYCHOLOGICAL,
SOCIAL
&
SPIRITUAL NEEDS.
INDIVIDUAL ACTIONS AS SOLUTIONS
DONOR CARDS / ADVANCE DIRECTIVES
MOTIVATING ONESELF AND OTHERS
MEDICAL
PROFESSIONALS
TO
PROMOTE
UNDERSTANDING OF BRAIN DEATH & ORGAN
DONATION
Possible Policy Options
Tighten Wording Of Act.
Remove Provisions For Spouse And `Affection And
Attachment'
Mandate 3rd Party Tissue Testing
Promote Cadaveric Program
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
Thank you
This post was last modified on 08 April 2022