Ethical and legal aspect of

transplant
Dr Vipin SHARMA
1 st yr Pg. Mch
• THOA 1994
• THO RULES, 1995 (ORIGINAL RULES)
• TRANSPLANTATION OF HUMAN ORGANS(AMENDMENT)RULES,2008
• THOA AMENDMENT 2011
• TRANSPLANTATION OF HUMAN ORGANS AND TISSUES RULES, 2013
• The bill made amendments in the Transplantation of Human Organs
Act, 1994.
• regularized the transplantation of human organ and tissue
• permit donations from living persons who are near relatives.
• grandparents and grandchildren to the list of “near relative”.
• consent
• permission to swap organs with another person. If no near relative available
• If organ donor is not a “near relative”, he required prior permission
from the state authorisation committee.
• Penalty for illegal removal of human organs and for receiving or
making payment for a human organ.
• The donor as well as the recipient would get penalized
• The bill offered for the establishment of advisory committees.
The Transplantation of Human Organs
(Amendment) Bill,2013-14
• Along with an authorization committee,
• There will be a ‘verification committee’ as well
• For the verification of the details that are offered by the donor and
recipient.
• Every block
• All legalities of the matter of organ transplant.
• living donation –
• it defines who can donate with legal formalities.
• mother, father, brothers, sisters, son, daughter, and spouse.
• The first relatives are required to provide proof of their relationship by genetic
testing and/or by legal documents.
• If no first relatives available
• special permission from the government appointed authorization committee
• an interview in front of the committee
• to prove that the motive of donation is purely affection for the recipient.
• Brain-death and its declaration
• two certifications are required 6 hours apart from doctors and
• these doctors should nominated by the appropriate authority of the government
• one of the two being an expert in the field of neurology.
Authorization Committee (AC) –
• regulate the process of authorization
• approve or reject transplants between the recipient and donor
• ensure that the donor is not being exploited for monetary for donate
their organ.
Appropriate Authority (AA )
• to regulate the removal, storage, and transplantation of human organs.
• To give license to hospital
• conducting regular inspections of the hospitals to examine the quality of
transplantation and
• follow-up medical care of donors and recipients,
• suspending or cancelling the registrations
• conducting investigations into complaints for breach of any provisions of the
Act.
• The AA issues a license to a hospital for a period of 5 years at a time and can
renew the license after that period.
• Each organ requires a separate license.
Working guideline
• Above the age of 18 years old),
• The following shall be evaluated:
• Results of tissue typing and other basic tests
• Documentary evidence of relationship e.g., Relevant birth certificates
and marriage certificate ect.
• If the relationship is not conclusively established after evaluating the
above evidence, direct further medical tests may done
• Test for human leukocyte antigen (HLA ), human leukocyte antigen-b
alleles to be performed by the serological and /or polymerase chain
reaction (PCR) based deoxyribonucleic acid (DNA) methods
• Tests shall be done from a laboratory accredited with national
accreditation board for laboratories (NABL).
• If above test do not establish a genetic relationship between the donor
and the recipient,
• The same tests should be performed on both or at least one parent, preferably both
parents.
• Relatives of donor and recipient
• For married couple,
• The registered medical practitioner i.E., The person in charge of the transplant centre
must evaluate the fact and duration of marriage
• Marriage certificate,
• Marriage and family photographs,
• Birth certificate of children containing particulars of parents).
• When the proposed donor or recipient or both are not indian
• the AC shall consider all such requests.
• A senior Embassy official of the country of origin has to
certify the relationship between the donor and the
recipient.
Donor and recipient not relative
• the Authorization Committee shall evaluate that there is no commercial
transaction
• Reasons why the donor wishes to donate
• Documentary evidence of the link, e.g., proof that they have lived together
• Old photographs showing the donor and recipient together
• There is no middleman should involved
• The financial status
• income for the previous three financial years.
• Any gross disparity between the status of the two must be evaluated with
the objective of preventing commercial dealing.
• all approvals should be subject to the following conditions:
• The approved proposed donor would be subjected to all medical tests
as required at relevant stages to determine his biological capacity
and compatibility to donate the organ in question.
• Psychiatrist's clearance
• donor's mental condition,
• awareness,
• absence of any overt or latent psychiatric disease, and ability to give free
consent.
• All prescribed forms have been completed by all relevant persons involved
in the process of the transplantation.
• All interviews should be video recorded.
• The AC should state in writing, its reason for rejecting or approving the
application of the proposed donor
• The AC is required to take a final decision within 24 hours of the meeting
for grant of permission or rejection for transplant.
• Every authorized transplantation centre must have its own website.
• The decision of the AC should be displayed on the notice board of the
hospital immediately and on the website of the hospital or institution
within 24 hours of making the decision.
Guidelines for composition of the AC
• There shall be one State Level AC.
• Additional ACs may be set up at various levels as per the
requirements :
• More than 25 – hospital
• less than 25 - Distric/state
• No member from the transplant team of the institution should be a
member of the respective AC.
Composition of a hospital-based AC
• Medical Director or Medical Superintendent of the Hospital
• Two senior medical practitioners from the same hospital who are not
part of the transplant team
• Two members of high integrity, social standing, and credibility
• Secretary (Health) or nominee and Director Health Services or
nominee
Composition of State or District Level ACs
• Medical Practitioner officiating as Chief Medical Officer or any other
equivalent post in a main/major government hospital of the district
• Two senior medical practitioners who are residing in the concerned
district and who are not part of any transplant team
• Two senior citizens of high reputation and integrity residing in the
same district
• Secretary (Health) or nominee and Director of Health Services or
nominee
Forms
• 1 (A) close relative
• 1(B) spouse
• 1 (C) other relative
• 3 certifies close relative
• 10 both donor and recipient
• Form 5 for cadaver transplant
• Form 6 signed by person lawfully in possession of cadaver
• Form 8 signed by all persons of medical board
• Form 9 signed by parents of minor cadaver donor
• To each person an equal share
• To each person according to need
• To each person according to effort
• To each person according to contribution
• To each person according to free market exchange
Deceased Donor Organ Allocation
• Principles are
• 1) principle of justice and equity
• On basis of social worth / merit
• By queue ( first come first served )
• By maximum benefit
• 2) Requirement of informed consent
• 3) Absence of conditionality
• Maximum benefit –
• Medical need
• Probability of success
• Maximize the number of successful transplants
• Reasons for maximum benefit:
• limited resource and should avoid waste
• Factor in medical outcome
• Ethical ,legal and psychological aspect of transplant FOR LIVING
ORGAN DONATION (ELPAT)
• Specified donation
• Direct donation
• Indirect donation
• Unspecified donation
How can we increase the pool of donors
ethically?
• Education
• Mandated choice
• Using ‘high-risk’ donors
• Opt-out system (presumed consent)
• Financial incentives
• Social incentives
• Increasing living donors
arguments for and against opt-out?
For
• It would increase the pool of
donors
• save lives
• Takes pressure off families
• Increases autonomy of donor
• Actually fulfils many people’s
wishes
Against
• Changes nature of ‘gift’ of organ
donation
• May induce backlash and reduce
donations
• Mixed evidence about whether
it would increase pool
• Advantages of living donor
• Improved graft survival
• Less recipient morbidity
• Early function and easier to manage
• Avoidance long waiting time for transplant
• Less aggressive immunosuppressive regimen
• Contra-indications for living donor
• Mental disease
• Disease organ
• Morbidity and mortality risk
• ABO incompatibility
• Crossmatching incompatibility
• Transmissible disease
 Expanding living donor pool criteria
• Elderly donors
• Obese donors
• Donors with isolated microscopic hematuria
• Donors with mild hypertension
• Donors with impaired glucose tolerance
• Donors with stones
• Donors with multiple renal arteries
• Donors with hyper echogenic renal parenchyma
• Donors with HCV
• Donors with history of malignancy
Counselling
• May involve professional counsellors/ psychotherapist
• Aimed at preventing / minimizing possible complication
• Need for adherence to post-op maintenance medications
• Regular follow-up thorough evaluation
• Life style modification; smoking, alcohol, sedentary life style, junks,
excessive salt ingestion.
consent
• Living Donor
• Education
• Willingly
• Not for any financial reason or under stress
• Most undergo extensive screening – medical, psychological
• Surgery and aesthetic complications outline to patients
• DECEASED DONOR Some Factors influencing refusal to consent by
relatives;
• non-acceptance of brain death.
• A delay in funeral
• Lack of consensus within family members
• Fear of social criticism
• Dissatisfaction with the hospital staff
• Various Superstitions & Religious beliefs
RECIPIENT
• Nature of disease and the need for transplant
• Outcome and complications
• Need for compliance to immunosuppressive therapy
• Other available options
Organ Market
• The vicious cycle – Needs money , has organ. - Has money , needs
organ.
• contrary to the dignity of the human body and depersonalizing
• Organ sale promotes coercion and exploitation of people, especially
of the poor.
• Insufficient screening compromises quality of organ and health of
both donor and recipient
• It promotes poor quality of care as a result of poor standards of
donor selection and inadequate screening for transmissible disease
WHO Guiding Principle 1
• Cells, tissues and organs may be removed from the bodies of
deceased persons for the purpose of transplantation if: –
any consent required by law is obtained
WHO Guiding Principle 2
• Physicians determining that a potential donor has died should not be
directly involved in cell, tissue or organ removal from the donor or
subsequent transplantation procedures;
• nor should they be responsible for the care of any intended recipient
of such cells, tissues and organs.
 WHO Guiding Principle 3
• In general living donors should be genetically, legally or emotionally
related to their recipients.
• Informed, voluntary consent
• Professional follow up ensured and organized
• Selection criteria
• Non coercive (by force)
WHO Guiding Principle 4
• Minors and legally incompetent people – No cells, tissues or organs
should be removed from the body of a living minor for the purpose of
transplantation
• Specific measures should be in place to protect the minor and,
• exceptions allowed under national law.
• wherever possible the minor’s parents consent should be obtained
before donation
WHO Guiding Principle 5,6,8
• Cells, tissues and organs should only be donated freely without any
monetary payment or reward of monetary value.
• The prohibition on sale or purchase of cells, tissues and organs does
not preclude reimbursing reasonable and verifiable expenses incurred
by the donor, including
• loss of income, or
• paying the costs of recovering,
• processing, preserving and supplying human cells, tissues or organs
for transplantation.
WHO Guiding Principle 7
• Physicians and other health professionals should not engage in
transplantation procedures, and
• health insurers and other payers should not cover such procedures, if
the cells, tissues or organs concerned have been obtained through
exploitation or coercion of, or payment to, the donor or his family
WHO Guiding Principle 9
• The allocation of organs, cells and tissues should be guided by
• Clinical criteria and
• Ethical norms,
• Not financial or other considerations.
• Allocation rules, defined by appropriately constituted committees,
should be
• Equitable,
• Externally justified, and
• Transparent
• Thank you