ORGAN TRANSPLANTATION IN INDIA AND JUDICIAL

APPROACH: A CRITICAL ANALYSIS

A project submitted in partial fulfilment of the course HEALTH

LAW, 10th SEMESTER during the academic year

2021-2022

SUBMITTED BY,

ADITYA BHARDWAJ
B.A.LLB, ROLL NO. 1705

SUBMITTED TO,

Mr. KUMAR GAURAV

FACULTY OF HEALTH LAW

MARCH, 2022

CHANAKYA NATIONAL LAW UNIVERSITY, NYAYA NAGAR,

MEETHAPUR, PATNA-800001
 DECLARATION BY THE CANDIDATE

I hereby declare that the work reported in the B.A. LL.B (Hons.) Project Report entitled
“ORGAN TRANSPLANTATION IN INDIA AND JUDICIAL APPROACH”
submitted at CHANAKYA NATIONAL LAW UNIVERSITY, Patna is an authentic
record of my work carried out under the supervision of Mr. Kumar Gaurav. I have not
submitted this work elsewhere for any other degree or diploma. I am fully responsible
for the contents of my Project Report.

(Signature of the Candidate)

ADITYA BHARDWAJ

Chanakya National Law University, Patna

03/03/2022

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 TABLE OF CONTENTS

1. ACKNOWLEDGEMENT……………………………………………………….4

2. OBJECTIVES OF THE STUDY…………………………………………………5

3. RESEARCH METHODOLOGY….……………………………………………..5

4. HYPOTHESIS…………………………………………...………………………5

5. RESEARCH QUESTIONS………………………………………………………5

6. INTRODUCTION……………………………………...………………………..6

7. RIGHT TO HEALTH AND JUDICIAL ACTIVISM......……………….………..7

8. THOTA 1994: IMPACT ASSESSMENT…....……...……..…………..….……..9

9. ROLE OF INTERNATIONAL ORGANISTATIONS TO STOP ORGAN

MARKET.............................................................................................................15

10. INFRASTRUCTURAL CONSTRAINTS…………….……..…………………18

11. PROBLEMS AND POSSIBLE SOLUTIONS………………………………….20

12. CONCLUSION………………………………………….………………….…..23

13. BIBLIOGRAPHY………………………………………….……………….…..24

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 ACKNOWLEDGEMENT

I WOULD LIKE TO EXPRESS MY SINCERE GRATITUDE TO MY PROFESSOR MR. KUMAR

GAURAV FOR PROVIDING HIS INVALUABLE GUIDANCE, COMMENTS AND SUGGESTIONS
THROUGHOUT THE COURSE OF THE PROJECT TITLED “ORGAN TRANSPLANTATION IN

INDIA AND JUDICIAL APPROACH: A CRITICAL ANALYSIS” WHICH ENRICHED ME WITH

INVALUABLE KNOWLEDGE. AND I WOULD LIKE TO EXPRESS SINCERE GRATITUDE TO THE

OFFICIALS AND OTHER STAFF MEMBERS OF THE UNIVERSITY WHO RENDERED THEIR HELP

IN COMPLETION OF THIS PROJECT. I WOULD ALSO LIKE TO THANK MY PARENTS AND

FRIENDS WHO HAVE HELPED ME WITH THEIR SUGGESTIONS AND GUIDANCE. LAST BUT

NOT THE LEAST I WOULD LIKE TO THANK MY CLASSMATES WHO HAVE HELPED ME IN

EVERY POSSIBLE WAY.

Moreover, thanks to all those who helped me in any way be it words, presence
Encouragement or blessings...

Aditya Bhardwaj
10TH Semester

B.A.LLB(Hons.)

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 OBJECTIVE OF THE STUDY

The objective of the researcher in doing the research work is to highlight the Judicial
Activism with regard to Right to health and the legislations for regulating organ donation
and transplantation activities. The researcher also aims to highlight some reported instances
to show whether implementation of law has been able to fulfil its purposes or not.

RESEARCH METHODOLOGY

The researcher would like to follow the doctrinal method of data collection. For it the
researcher has made extensive use of the internet sources.

SOURCES OF DATA
For this study, both primary and secondary sources are utilized. In Primary sources
researcher has relied upon the landmark judgements, bare acts and books. And in the
secondary sources the researcher has made use of newspapers, journals, books.

HYPOTHESIS

1. Law has not been able to fill the gap between demand and supply of organs.
2. Lack of an appropriate organ donor is a frequent problem.

RESEARCH QUESTIONS

1. What are the moral and policy problems of organ transplantation technology?
2. Where are the gaps present in the implementation of the THOTA, 1994?
3. What are the possible solution with regard to transplantation concerns?

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 INTRODUCTION

One disease which captured the attention of the medical professionals all over the
world in early 1900s and throughout the first half of the 20th century was solid organ
failure. With the advent of advanced medical technology in transplant procedures an
end stage organ failure patient got a ray of hope to lead a healthy and prolonged life
by undergoing organ transplant. Law and medicine join a common pilgrimage towards
all pervasive welfare of human life. Over the years, with the revolutionary changes
brought about in social, economic, political and scientific fields of human activity,
human organ transplant as a curative medical technique gained public acceptance in
India too.

To facilitate transplants for saving the lives of organ failure patients and to safeguard
the interests of the organ donors, the Transplantation of Human Organs and Tissues
Act was passed in India in 1994. The enactment furthers the cause of human existence
by regulating and facilitating transplants, gives thrust to policies recognising values
which are integral to dignified human existence. The THOTA , 1994 was enacted at
the time when in India due to absence of any legislation, rampant sale of human organs
was going on with an aim to streamline organ donation and transplantation activities.
Broadly, the act accepted brain death as a form of death and made the sale of organs a
punishable offence. With the acceptance of brain death, it became possible to not only
undertake kidney transplantations but also start other solid organ transplants like liver,
heart, lungs, and pancreas. However, in most of the reported instances, the
implementation of the law has been flawed and more often than not, its provisions have
been abused.

The Supreme Court has held that ‘right to health’ is an integral part of ‘right to life’
under article 21 of the Constitution. And that preservation of human life is of
paramount importance.3 Organ transplant technology has emerged on the scientific
horizon as a gift of life to people suffering from end stage organ failure disease. The
development in transplant technology with immunosuppressant drugs has made the
transplant of both (i) living related or/and unrelated and (ii) deceased organs, a viable
option for people suffering from organ failure. Their chances of survival and ability to
lead a healthy, prolonged life is completely dependent on availability and accessibility
of transplantable human organs.

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 RIGHT TO HEALTH AND JUDICIAL ACTIVISM

In India during the last four decades or so the issue of health has gained Momentum.
Judgements delivered in Parmanand Katara vs Union of India, Indian Medical
Association vs VP Shantha and Paschim Banga Khet Mazdoor samity vs State of West
Bengal are few amongst many Supreme Court decisions which strengthens the
recognition of the right to health. The Apex courts activism through various decisions
observed that denial of immediate medical attention to a patient in need amounts to
violation of protection of life and liberty guaranteed under Article 21. Likewise holding
that a provision of a medical service (whether diagnosis or treatment) in return for
monetary consideration amounts to a service for the purposes of Consumer Protection
Act, 1986 went a long way in protecting the interest of the patients.

In the history of Indian judiciary the case of Maneka Gandhi v. Union of India has been
a watershed in expanding the horizons of fundamental rights in general and Article 21 in
particular. The court moved from a pedantic to a purposive approach in construing the
sweep of the 'right to life’ under the Constitution. Maneka Gandhi judgment became a
springboard for the evolution of human rights jurisprudence and the basis for the
subsequent expansion of the understanding of the ‘protection of life and liberty’ under
Article 21 through expansive interpretation of Fundamental Rights guaranteed in part III
of the Indian Constitution. The Supreme Court of India further went on to adopt an
approach of harmonization between fundamental rights and directive principles in
Indian Constitution in several cases.

Law and medicine join a common pilgrimage towards all pervasive welfare of human
life. Over the years, with the revolutionary changes brought about in social, economic,
political and scientific fields of human activity, human organ transplant as a curative
medical technique gained public acceptance in India too. To facilitate transplants for
saving the lives of organ failure patients and to safeguard the interests of the organ
donors, the Transplantation of Human Organs and Tissues Act was passed in India in
1994. The enactment furthers the cause of human existence by regulating and
facilitating transplants, gives thrust to policies recognizing values which are integral to
dignified human existence. It has come as a boon to trillions of humans suffering from
ESOF. Various organs can be legally transplanted by virtue of THOTA, 1994 giving
gift of life to people otherwise doomed to die on account of ESOF.

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 MORAL AND POLICY PROBLEMS OF ORGAN
TRANSPLANTATION TECHNOLOGY

Rapid advances in the field of transplantation technology, have resulted in the widening
of the already existing gap between the supply and demand of organs. This raises
numerous moral and policy problems for the medical profession and the general public,
which remain to be successfully tackled by the lawyers, in general, and the state, in
particular. The most crucial issue being that when the number of organs is insufficient
to meet the demand, what policies should be instituted to help increase the availability
of these precious tissues? The Indian Government rightly decided to address the
problem of shortage of organ donors, and the other obstacles that patients in need of
this remarkable new medical technology must confront, not to mention repercussion of
this medical advancement on the lower strata of society, who are identified as potential
donors. Thus, on 8 July 1994, the President of India assented to the Transplantation of
Human Organs Act (THOA) providing 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." By adoption of this Act, the various State Legislatures prohibited all organ
sales.

One opines that such a broad prohibition may have been a hasty and inappropriate
measure. Unfortunately, the potential superiority of some form of payment for human
organs had never been given a serious thought by Parliament and State Legislatures.
There are of course several theoretical bases justifying intervention by the State to
prohibit the sale of body parts, but one believes that the above mentioned legislation
does not derive from a comprehensive jurisprudential and philosophical theory. Rather
it is likely that THOA represents little more than a hurried and intuitive recoil from what
appeared to be a fundamentally degrading process which is likely to have adverse
effects on society's values as a whole. The legislative history of THOA reveals that the
legislators simply assumed that the sale of human organs transgressed fundamental
norms without seriously considering the merits of the donors or their families. Any one
of the numerous issues pertaining to organ transplantation is a subject of lengthy debate.
The diverse issues include scientific, legal, medical, educational and regulatory aspects
of transplantation. There is need to clearly define the difficulties.

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 THE TRANSPLANTATION OF HUMAN ORGANS AND
TISSUES ACT 1994: IMPACT ASSESSMENT
The transplantation of organs from one individual to another has increased dramatically
in recent years. The advent of new immuno-suppressive drugs and the donor specific
blood transfusion have greatly improved the survival of grafted organs. While the
medical technology and knowhow continue to expand the possibilities of organ
transplantation and increased success rates of such transplant surgeries, the number of
organ donors does not increase correspondingly.1 This gap in demand and supply of
transplantable organs results in illegal trade in organs. Despite the legislation, organ
commerce generally and especially kidney scandals are regularly reported in the Indian
media.2 In most of the reported instances, the implementation of the law has been flawed
and more often than not its provisions have been abused. Though the living related and
unrelated donation program has established itself but the deceased donation program is
still in its nascent stage only.

Initially for many years there was a lack of initiative from the government to find
solution to rampant sale of organs after the Act was passed. Whenever a kidney scandal
was unearthed there was an instant reaction from different quarters, there was some
media outcry and if the allegations were found to be serious a few small time brokers
were rounded up and life carried on till another such episode came to light and the same
act was repeated. Realizing the need to move forward with changing needs of the society
and to make the regulation of organ transplant procedure with all the incidental
paraphernalia meaningfully effective, periodic amendments have been made to the
THOTA, 1994 in more than two decades since its enforcement.

Even a cursory look into the statistics available on the official website of National
Tissue and Transplant Organization3 reveals the fact that despite amendments in the
Act, the cadaver organ donation program has not picked up over the years. In the face
of all organ donations numbering 14038 from living donation category from 1971-2019,
the figures for deceased (cadaver) donation in the same period stand at a dismal 315

1
http://organindia.org/wp-content/uploads/2014/11/ORGAN-Research-Report.pdf
2
“Despite Efforts, India Remains an Easy Market For Illegal Organ Trade”, available at:
https://www.youthkiawaaz.com/2016/12/organ-trade/.
3
Hereinafter referred as NOTTO. Notto has been launched under the aegis of NOTP in Nov. 2015 by
the Union Health Minister under the Ministry of Health and Family Welfare, GOI. Available at :
http://notto.nic.in/organreport.htm

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only. The high demand of organs has led to its commodification, more so in developing
countries where there is a large population base below the poverty line with weak
regulatory authorities like in India. But there are examples of legislations in countries
like Spain, Iran and Iraq which have been successful in bridging the gap between
demand and supply of transplantable organs. Countries with laws legalizing ‘presumed
consent’ and actively involved transplant coordinators4 in ICUs have succeeded in
meeting the dearth of donor organs.

The reason for miniscule organ donation in India can be attributed to lack of awareness
about the concept of organ donation in masses. Another important factor is the ethical,
religious, and emotional constraints which discourage individuals to go for organ
donation. In India, the potential for deceased donation is huge due to the high number
of fatal road traffic accidents but this pool is yet to be tapped.5 Frequent amendments
made to the Act are testimony to the fact that in past Indian legislation has somewhere
lagged behind in comparison to other countries which have incorporated new ways to
find solution to the problem of organ shortage. The following section identifies the
stumbling blocks in achieving the objectives of the legislation.

4
THOTA, 1994, s. 2(q) states, “transplant co-ordinator” means a person appointed by the hospital for
co- ordinating all matters relating to removal or transplantation of human organs or tissues or both and
for assisting the authority for removal of human organs in accordance with the provisions of s. 3.
5
“How cadaver organ donation could turn government hospitals into donor bases that cater to the
affluent”, available at:
http://economictimes.indiatimes.com/articleshow/52591608.cms?utm_source=contentofinterest&utm_
medium= text&utm_campaign=cppst

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 GAPS IN THE IMPLEMENTATION OF ACT OF 1994

The reason for miniscule organ donation in India can be attributed to lack of awareness
about the concept of organ donation in masses. Another important factor is the ethical,
religious and emotional constraints which discourage individuals to go for organ
donation. In India the potential for diseased donation is huge due to the high number of
fatal road accident but this pool is yet to be tapped. Frequent amendments made to the
act are testimony to the fact that in past Indian legislation has somewhere lagged behind
in comparison to other countries which have incorporated new ways to find solution to
the problem of organ shortage. Patients’ silent screams, their family’s unending efforts
and doctor’s helplessness in saving the patient due to scarcity of compatible donor
organs, all point in the direction that there still are issues which have been left
unattended and need some solutions. The Transplantation of Human Organs and Tissues
Act, 1994 banned organ trade more than two decades ago but it cannot be overlooked
that an arrangement of buying and selling of organs is still continuing. Some issues
which have marred the organ donation and transplantation programme in India have
been discussed hereunder.

A. Consent and organ donation: In cadaver donation the consent of the deceased
before his death is a pre-requisite for removal of his/her organs upon death. There
are three processes through which consent may be given. First is ‘opt-in’ consent,
second is ‘opt-out’ and the third is ‘mandated choice.’ In India we have the ‘opting-
in’ form of consent for retrieval of organs from deceased. It is based on the principle
of ‘authorisation’, an expression which is intended to convey that people have the
right to express, during their lifetime, their wishes about what should happen to their
bodies after death, in the expectation that those wishes will be respected. It is a
positive concept, representing a positive attitude to the issue, and replaces the lack
of objection or ‘presumed consent’. Authorisation to remove an organ of a deceased
reflects the principle of ‘consent’ on which the THOTA, Trans1994 is based.
Section 3(1) of the Act permits any donor subject to prescribed conditions and the
procedure to donate or authorise the removal of any of his organs or tissues of his

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 body, before his death only for therapeutic purposes.6 The consent for the donation
of organs can also be given by the kin of the deceased, under section 3(3) of the Act
provided the deceased had not objected to the donation during his lifetime.

Such consent can be in writing, in presence of two or more witnesses, one of whom
has to be a ‘near relative’. And if it is so, then besides the relatives in whose
possession the dead body is, even the person, other than the relatives, can grant all
reasonable facilities to a registered medical practitioner for the removal of the
human organ of the deceased person for therapeutic purposes, provided that such
removal can be made only and only by a registered medical practitioner. Here only
embargo being that relative or person in whose possession the body is, should be
sure that deceased had not subsequently revoked that authority or person other than
the relative has a reason to believe that any near relative has no objection to such a
removal. This type of consent is known as opt-in concept, in which the deceased
person has already opted for the removal of the organ before his death.

B. Role of Relatives, emotional barrier: Under the Act even if the individual has
opted-in or has given his consent for organ donation after his death, his wish to
donate his organs cannot come true if his family is not ready for the donation.7
Despite the open declaration of his consent and wish to donate organs after his death,
it’s the approval of family which is needed for such donation. Thus the provision of
free will of the deceased is nothing but a misnomer because inspite of his opting for
the organ donation, his wish becomes secondary to the wishes of his family. For the
Act to be effective in its real sense the opt-in-consent provision should be made
effective meaningfully to respect the wish of the deceased donor. And with large
scale awareness programmes about organ donation and more and more people
coming forward to pledge their organs, the dual objectives of the Act could easily
be achieved. Generally the power given in section 3(2) to the relative in lawful
position of the dead body by virtue of which they are authorized to give consent for
organ removal, are not prepared for such authorization and thus, this organ donation

6
S.3(1) of THOTA 1994, available at: http://lawmin.nic.in/ld/P-
ACT/1994/The%20Transplantation%20of%20Human%20Organs%20and%20Tissues%20Act,%20199
4.pd f
7
FAQ’s,“Deceased donor related transplants’, Answer to question no. 15”, available at
http://notto.nic.in/faqs.htm.

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 becomes difficult. The act of obtaining consent of the relative works as a stumbling
block in successful running of the cadaver donation program. The relatives of the
patient are not forthcoming, and the doctors not motivated enough to encourage
donation.

Cultural perception of charity and donation is different in different religions. In

India, religious beliefs generally discourage practices such as stockpiling and
collecting organs from cadavers. It is difficult for a grief stricken family to
understand the concept of cadaver donation when his loved one has been declared
dead and to take a decision of permitting doctors to retrieve organs for which the
corpse would be mutilated. Myths and fears dominate their minds. The very thought
of dismemberment of the body of their loved one’s makes them repulsive to the ides
of organ donation. The pre-conceived religious beliefs/myths that in rebirth a person
is born in the same state of body condition as he was at the time of death deters
them to give consent for removal of any of the body parts. They find taking out
organs/tissues very repulsive and perceive it as a kind of disrespect for the dead
body of their relative. Though generally all religions permit donation, people are
still unwilling to donate organs. Instead they use religious misconceptions as
excuses for not donating organs Thus permission for cadaver donation by family of
the deceased has still not gained momentum.

C. Distrust against the medical staff: It is trickier and very difficult situation to
approach a grieving family asking them for donation of organ(s) of their beloved
one’ especially when his heart is beating which creates a wrong impression in their
minds that there can be some mischievous intentions on the part of the medical/
hospital staff. The emotional turmoil of losing a dear one deprives them of their
logical thinking. They apprehend that if they agree for donation the hospital staff
may not take proper care of their beloved one because somewhere underneath they
are unaware about the brain-stem death concept. Hence they believe that their
beloved could be saved even after brain death. Likewise the written consent for
donation of organs post demise that can be given during the life time by a
prospective donor may not be given by the person concerned. This would be so on
account of entertaining a belief that in order to generate organ resources the hospital
administration might not provide him that standard of medical care as might be
required by him to recuperate fully and to walk out of the hospital in a healthy state.

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D. Right to life of a specific class of ESOF Patients: In the present dismal state of
cadaver organ programme, the laws regulating transplants and activities associated
with it have adversely affected a particular class of patients. The ways in which a
donor organ can be procured as provided in the Act does not entitle all the ESOF
patients to procure a donor organ. By virtue of section 9 of the Act8 a ‘class’ of
ESOF patients is excluded from transplant treatment ,who are in desperate need of
the transplantable organ to save their lives but neither have a biologically compatible
‘near relative’ nor an altruistic donor. Nuclear families with one or two children
who may not be biologically compatible and the related contextual social
architecture of families reduces the possibility of finding a live donor from amongst
near relatives. For example an orphan, a person losing his family in a train accident
or in floods or in some other natural calamity will not have any ‘near relative’. This
class of patients are solely dependent on the cadaver donation and in the absence of
an efficient and functional cadaver organ donation programme the patients
belonging to this class are bound to die waiting for the transplantable organ. Thus
this class of ESOF patients is denied their right to health and cannot save their lives
in present scenario. At the same time it should not be forgotten that article 21 besides
ensuring ‘right to Health’ and ‘healthcare’ also ensures ‘right to self-preservation’
to everyone.9

In its ambitious journey to regulate organ transplantation by promoting cadaver

donation and prohibiting commercial dealings in organs, section 9 of THOTA 1994
restricts a critical patient’s right to life, to avail the latest available medical
procedures more so in the absence of any effective cadaver donation program. The
real and direct effect of section 9 of the Act is impairing the right to life of the class
of patients who do not have ‘near relative’, willing relative or no altruistic donor.
Though under the Act provisions are laid down for procurement of organs but the
special class of patients as noted cannot have access to any type of donor organ and
thus the direct effect of the legislation is infringing patient’s right to health.

8
THOTA, 1994, s. 9 states, “Restrictions on removal and transplantation of [human organs or tissues or
both].—(1) Save as otherwise provided in sub-section (3), no [human organ or tissue or both] removed
from the body of a donor before his death shall be transplanted into a recipient unless the donor is a near
relative of the recipient.”
9
Surjit Singh v .State, AIR 1996 SC 1388.

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 ROLE OF INTERNATIONAL ORGANISATIONS TO STOP
ORGAN MARKET

Over the past 3 decades, numerous international bodies have called for prohibitions on
involuntary and paid removals of organs, and the majority of countries have explicitly
banned and criminalized trade in organs and related activities. Most countries have also
forbidden and criminalized trafficking in persons including for the purpose of organ
removal. In recent years, several countries have sought to strengthen national legislation to
address vulnerabilities that made it difficult to prosecute many of those who profit from
transplant-related crimes. As a result, trafficking in human organs and trafficking in
persons for the purpose of the removal of organs are recognized as criminal offenses and
punishable in an increasing number of countries.
Laws governing trafficking in human organs and trafficking in persons for the purpose of
organ removal should aim to hold those who profit from transplant-related crimes
criminally accountable and to protect those who may be victims. The involvement of
‘donors’ or recipients in the sale or purchase of an organ should be prohibited. However, it
is for national governments to decide whether to also criminalize these persons for their
involvement in these acts. Many people who have been the victims of trafficking are
financially vulnerable and may face barriers to obtaining legal support. The legal
protections and social and medical support provided to victims of human trafficking should
also be guaranteed for victims of organ trafficking. Such protections are required under
international human rights instruments and have the practical benefit of making it more
likely that these victims will come forward and report what has occurred. Health
professionals or others who provide information to support investigation of suspected
transplant-related crimes should also be legally protected as whistle-blowers.
To be effective, legal prohibitions need to include a ban on all types of advertising
(including electronic and print media) or brokering for the purpose of facilitating organ
trafficking or trafficking in persons for the purpose of organ removal. Health professionals
who intentionally facilitate trafficking, including by failing to adequately evaluate
prospective living donors and transplant recipients or by knowingly removing or
transplanting trafficked organs, should be held criminally accountable and not merely risk
disciplinary sanctions for professional misconduct.
Law enforcement agencies (inclusive of international agencies) should receive specific
training and guidance considering the diverse and subtle manifestations of these crimes and

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should work on effective ways of ensuring cooperation with health authorities in addressing
these crimes.
"Organ donation should be a financially neutral act."
Just as donation should not enrich donors (or the next of kin of deceased donors)
financially, it should not burden them financially. Achieving financial neutrality or, at the
very least, reducing the financial burdens of donation enables more people to donate and
improves equity in donation and transplantation.
This principle emphasizes that the prohibition of trade in organs and financial incentives
for donation does not preclude efforts to prevent financial injury to donors. As the World
Health Organization and other national and regional bodies recognize, comprehensive
reimbursement of verifiable expenses related to donating an organ does not constitute
paying for the organ but is part of the total cost of treating the recipient. However, although
most health systems that provide organ transplantation treat the medical expenses of
removing, preparing, and transporting a donated organ for implantation as part of the cost
of performing a transplant, not all systems cover the costs related to donation, even when
their laws permit such reimbursements. This may be due to the unavailability of resources
to cover all costs of donation. It may also be due to the belief on the part of health
policymakers, healthcare institutions, or health professionals that providing a payment to
cover the costs of donation would violate the prohibitions against trade in organs.
When kidney-paired donation programs were first being developed, the question arose
whether an exchange of kidneys amounted to the giving of “valuable consideration” to
obtain a kidney. Kidney-paired donations and organ chains triggered by “Good Samaritan”
(nondirected altruistic) donors allow patients who are biologically incompatible with a
living related donor to exchange that donor's kidney for one that would be compatible. So
long as the donors or their beneficiaries receive no financial gain or comparable advantage
in exchange for their donation or participation in a paired exchange, the principle of
financial neutrality has not been violated.
The Declaration of Istanbul on Organ Trafficking and Transplant Tourism (DoI) was
adopted in 2008 at an international meeting organized by The Transplantation Society and
the International Society of Nephrology. Two years later, these sponsors established the
Declaration of Istanbul Custodian Group (DICG) to oversee dissemination of the document
and to aid professional societies and governments in combatting organ trafficking. In 2017,
the DICG began the process of reviewing and updating the DoI to ensure that it provided
clear and current guidance for policymakers and health professionals working in organ

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donation and transplantation. The new edition of the Declaration, which was released on
July 1, 2018, at the International Congress of The Transplantation Society in Madrid, drew
on feedback from an online public consultation on a draft of the revised Declaration,
prepared by an ad hoc working group established by the DICG. The 2018 Edition provides
updated definitions of key terms, and a more clearly structured and succinctly worded set
of principles. A decision was made during the update process to move the set of practical
“proposals” that had been part of the 2008 Declaration into a companion article that would
also explain concepts, offer justifications for normative positions, and provide examples of
how the Declaration can be applied in practice.

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 INFRASTRUCTURAL CONSTRAINTS

Cadaver transplants require expensive, specialized and diverse infrastructure systems to

be in place and functioning. Hospitals need the required facilities, such as equipment,
operating rooms, laboratories to conduct cross- matching and trained personnel available
at short notice and around the clock for such transplants.10 Time is of essence in such
transplants, because organs have a limited life span, before expiry of which both removal
and transplantation have to be effectively carried out. With 17 lives lost in road accidents
every hour last year and 390 fatalities recorded daily, the Union Health Ministry said organ
donated from such victims with proper consent of their family members can help the
country’s abysmally low organ donation rate. For brain death patients to convert into real
donors a responsive, rapid and efficient medical facility is crucial. In present scenario even
if we presume that these efforts prove fruitful and considerable number of donor organs is
generated, it would still be a long journey in the absence of appropriate infrastructure.

Transplantation operations involving cadavers in India are more complicated and rare due
to the lack of facilities e.g., facility for the resuscitation of the victim at the accident spot,
lack of well-equipped hospitals, shortage of trained personnel in the ICUs, lack of quick
communication and proper transport facilities, as well as inadequate public awareness
amongst other reasons. Thus for all practical purposes cadaveric donation technology is
almost missing or negligible considering the number of brain-stem death patients in India.
Presence and availability of such an infrastructure along with the availability of cadaver
organs together can make transplants possible. And for such specialized, diverse and
expensive infrastructure, availability of funds plays a very significant role. In India, the
budgetary allocation of funds for health sector is one of the lowest in comparison to other
countries. In order to make the Act really effective funds should be provided in the budget.

There is no data available to tell how many ESOF patients have died due to unavailability
of donor organs till today. ESOF patients come to the hospital in a hope to walk back
healthy, but die enduring pain, suffering, waiting and leaving their families distraught and
under huge debt which takes years for them to come back to life. Sanjay Aggarwal, head

Kyara Mathias, “The Organ Trade Dilemma”, Apex Courts Expressions, Journal Section, (2003)7
10

ACE(J) at7

18 | P a g e
of nephrology department at AIIMS said:11

…. they have 500 patients register for cadavers at any time.

The number of cadaver donation is less than 15 in a year. He
also added that about 5.4 lakh patients require kidney
transplant every year but only 6,000 are able to get it. The rest
either survive on dialysis which in simple terms is cleaning of
body waste or die without the transplant.

Dialysis being very costly almost costing Rs.32,000 per month, it is only the rich who
can afford to live on dialysis that too for few years. A poor or middle class patient does
not have economic capacity to survive on dialysis in India. In case an ESOF patient
cannot arrange a biologically compatible ‘near relative’ organ donor for himself or who
has no willing family member to donate and none feeling enough love and affection to
donate an organ to save him, is bound to die. And considering the poor and abysmally
low organ donation rate what would be the fate of an orphan who is diagnosed as being
at the critical state of ESOF having neither family nor friends is not unimaginable. For
him going by law means waiting for DEATH.

In retrospect, neither has organ commerce been curtailed nor has cadaveric donation
become the norm.12 Somewhere in all these years various factors have been responsible
in failing the Act to achieve its objectives of facilitating transplants and banning organ
trade.

11
Durgesh Nandan Jha,”Kidney Crisis: Endless Wait at AIIMS”, Print edition, Time of India Aug.19,
2013.
12
Ramya Kanan, “Cadaveric Organ Donation Caught In India In Bureaucratic Bind”, The Hindu,
Chennai, updated Aug. 6, 2013., available at www.thehindu.com

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 TRANSPLANTATION: PROBLEMS AND POSSIBLE
SOLUTIONS

Besides inadequate finance, any organ transplant programme in India faces many
problems: ignorance, lack of appropriate organ donors and proper medical facilities.
Transplant facilitators, the press and the medical fraternity compound the problem.
Ignorance exists even among educated people regarding the seriousness of diseases
such as diabetes and hypertension, which can lead to kidney failure. Many patients do
not follow medical advice of planning in advance for transplantation, by identifying
and working up a donor even before they reach a stage requiring dialysis. Such
preparation can reduce the complications and expenses incurred on dialysis. Moreover,
most patients and their families are not aware of the complications which can occur
during and after transplantation such as infection and rejection; these can adversely
affect both graft and patient survival. Even if they are warned about this, they tend to
ignore or fail to understand this.

Finance is a major factor in the management of any end-stage organ failure. Treatment
of chronic organ failure is accorded low priority in the public health system due to
financial constraints. The approximate cost of live-related kidney donor work up
ranges between Rs 30,000 and Rs. 40 000. The approximate cost of kidney
transplantation would be between Rs 200 000 and Rs 300 000, inclusive of donor and
recipient surgery, admission for a week and investigations. Finances for the transplant
is arranged through family funds, taking a loan, selling property and/or taking charity.3
Unfortunately, finance through insurance has not taken off much in India. The cost of
immunosuppressive medication ranges between Rs 10 000 and Rs 20 000 per month
in the initial stages. The subsequent cost depends upon the course of recovery after
transplantation. Lack of an appropriate organ donor is a frequent problem. The
shortage of related donor kidneys, the lack of a deceased donor programme and large
scale poverty has led to trafficking in organs.

Despite the Transplantation of Human Organs Act enacted in 1994, a large number of
‘commercial’ transplants from unrelated donors are still done in India. Small nuclear
families and families with a strong history of diabetes or hypertension, and those whose
family members are unwilling to donate due to nonmedical reasons desperately need a

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kidney and turn to the easy option—an unrelated donor. This can be overcome if
deceased organ donation is implemented in a proper manner. Since 1994 when the
Transplantation of Human Organs Act became law, fewer than 1000 deceased donor
transplants have been done in India. The problem with the deceased organ donation
programme includes lack of government funding, hospitals not identifying and
maintaining brain dead donors and the community being unaware of the concept of
brain death. There are also hurdles to sharing organs, mainly between government and
private hospitals. Some neurosurgeons and neurophysicians refuse to certify brain
death. Though there are a few good public and private tertiary care hospitals with
laboratories in cities and a few towns, smaller towns and all villages lack well-equipped
hospitals and this has a negative impact on the success of transplantation. This forces
the patient to travel a fair distance for testing and check-up, adding further to the
financial burden. A ‘transplant facilitator’ is a glorified title given to a person who
brokers the deal between a donor and a patient. He/she is the main person in unrelated
commercial renal transplantation and this role needs to be strongly condemned. The
press seems to be a problem as it only focuses on the negative aspects of
transplantation, though it could be a real facilitator for a successful organ donation
programme.

Many kidney scams have been reported in various newspapers since 1995. These
incidents need to be reported but not sensationalized. Had the same energy been spent
in educating the public and in promoting deceased organ donation, the scenario in India
would have been different. Organ donation as a legitimate therapy for renal failure is
rarely discussed in newspapers.13 Finally, we in the medical profession have to
shoulder the blame too. Very few believe in educating the public and their patients
regarding health issues. An organ transplant programme needs determination on the
part of all those involved in making such programmes successful. The responsibility
rests on society as well as the medical fraternity.

The solutions are educating the public, implementing and making changes to the law,
promoting deceased organ donations, keeping ‘transplant facilitators’ away and
punishing the guilty. Education about organ failure, its prevention, possible solutions

13
https://www.sjkdt.org/article.asp?issn=1319-
2442;year=2019;volume=30;issue=4;spage=943;epage=952;aulast=Yadla#:~:text=An%20Act%20to%
20provide%20for,Act%20(THOA)%2C%201994.

21 | P a g e
and organ donation is urgently needed. This could be through simple lectures at public
gatherings, in schools and colleges to students, and through the print and audiovisual
media. We need to harness the strength of icons in Indian society—film personalities,
sports persons, politicians and the media—to endorse organ donation. The media can
effectively spread the message of organ donation to the masses. Indeed, including the
concepts of brain death and organ donation in the high school syllabus would lead to
change over time. Keeping the ‘transplant facilitator’ out of the process should not be
difficult. These persons bring disrepute to the whole programme. Implementing the
law is possible provided there is a determination to do so. Looking at the recent scams
one wonders whether any law exists. The most frequent complaint made by paid
donors is regarding non-payment or under-payment for the donated organ. They rarely
complain about the removal of the organ since they are willing sellers. Most of the
time following such a complaint, the police arrest the transplant physician and/or
surgeon. The hospital administrator, the donor himself, the patient and his relations are
allowed to go scot free. If the donor and recipient are also held culpable and punished,
illegal transplants could surely be reduced and eliminated over time.

The following measures can help in solving non-medical problems in organ

transplantation in India:

1. Reducing the shortage of organs by promoting deceased organ donation with

presumed consent and by educating the public.
2. Reducing the problem of finances by bringing in insurance, roping in
philanthropists, getting some government help and requesting pharmaceutical
companies to reduce the cost of medicines (robbing Peter to pay Paul).
3. Strict policing for illegal transplants and punishment of all the persons involved.
It is time that the medical fraternity took a strong stand on this issue and started
promoting the concepts of brain death and deceased organ donation.

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 CONCLUSION & SUGGESTIONS

Every year thousands of patients die of ESOF disease. National Organ and Tissue
Transplant Organization, a national level organization set up under Directorate
General of Health Services, Ministry of Health and Family Welfare, Government of
India established in November 2015 in Delhi has to adopt a comprehensive approach
for ensuring that ESOF patients do not die for want of a transplantable organ. Legal
tools are a necessity in organ procurement to allow transplant surgeons to remove
organs from potential sources.

In India THOTA, 1994 was enacted with intent to pave the way for smooth procedure
for organ transplants so that lives of patients suffering from organ failure could be
saved. “With around 1,60,000 people dying in road mishaps in the country every year,
the pool of potential brain dead donors is large. In fact if all brain dead accident
victims are declared donors, maintained and taken up for organ retrieval there would
be no need for the living to donate organs to relatives.” But the law has not been able
to fill the gap between demand and supply of organs. The progressive law to promote
organ donation has been brought on the statute book but in reality and for practical
reasons it has not yielded desired results. It is suggested that we need to switch over
to either presumed consent or Opting-out system of consent and tap cadaver organ
pool from traffic accidents, brain dead patients along with generating awareness
amongst masses about organ donation.

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 BIBLIOGRAPHY

Websites:
1. www.thehindu.com
2. http://lawmin.nic.in/ld/P-
ACT/1994/The%20Transplantation%20of%20Human%20Organs%20and%20Tis
sues%20Act,%201994.pd f
3. http://notto.nic.in/faqs.htm.
4. https://www.narayanahealth.org/organ-transplant/
5. http://www.mciindia.org/know/rules/ethics.htm
6. https://www.who.int/transplantation/organ/en/
7. http://14.139.60.114:8080/jspui/bitstream/123456789/17698/1/018_Organ%20Tr
ansplantation_Legal%20Framework%20Examined%20%28299-311%29.pdf
8. https://www.sjkdt.org/article.asp?issn=1319-
2442;year=2019;volume=30;issue=4;spage=943;epage=952;aulast=Yadla#:~:tex
t=An%20Act%20to%20provide%20for,Act%20(THOA)%2C%201994.

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