American J Transplantation - 2021 - Shroff - Bold Policy Changes Are Needed To Meet The Need For Organ Transplantation in

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Received: 25 November 2020    Revised: 1 February 2021    Accepted: 10 February 2021

DOI: 10.1111/ajt.16537

PERSONAL VIEWPOINT
AJT

Bold policy changes are needed to meet the need for organ
transplantation in India

Sunil Shroff1 | John S. Gill2

1
Urology and Transplantation, Madras
Medical Mission Hospital, Chennai, India Twenty-­five years after India passed legislation to legalize brain death, deceased
2
University of British Columbia Faculty of donor transplantation remains underdeveloped while the country has established
Medicine, Vancouver, BC, Canada
formidable capacity for living donor transplantation. Because of a large number of po-
Correspondence tential deceased donors, there is hope that deceased donation could help meet India's
John S. Gill, University of British Columbia
Faculty of Medicine, Vancouver, BC,
enormous need for organ transplantation. However, significant policy and practical
Canada. barriers limit progress. The vast majority of potential deceased donors are poor motor
Email: jgill@providencehealth.bc.ca
vehicle accident victims who present for care in hospitals without the necessary in-
frastructure or expertise to support deceased donation. In contrast, transplant infra-
structure and expertise are concentrated in private hospitals and are only accessible
to those with the ability to pay. Given these realities, the potential of deceased donor
transplantation can only be recognized if Indians who are likely to donate organs are
also provided access to transplantation. In this viewpoint, we review the current status
of organ transplantation in India and propose new policies to establish a national or-
ganization to oversee deceased donor services in all states, to fund resources needed
to support deceased donation, to leverage the existing living donor infrastructure to
advance deceased donor transplantation, and call for establishment of government
policy on funding for posttransplant care and immunosuppression.

1  |  I NTRO D U C TI O N only a small number of deceased donor transplants. In 2019, 88%


of 9751 kidney transplants and 77% of the 2590 liver transplants
In 1994 Indians with end-­stage heart, lung, and liver disease were performed in India were from living donors.5 In comparison, in 2018
doomed to die and only a few wealthy patients with kidney failure only 36% of kidney and 19% of liver transplants performed glob-
could obtain a living donor transplant. In response to embarrassing ally were from living donors. 6 A quarter century after the THO Act,
revelations about the black market in kidney transplants and the ab- transplantation remains inaccessible for most Indians with end organ
sence of extra-­renal transplantation, the Indian government passed failure. An estimated 220,000 persons die of chronic kidney disease
the Transplantation of Human Organs (THO) Act.1-­4 The THO Act in India annually.7 The burden of extra-­renal end organ failure is
legalized brain death and made the sale of organs a punishable of- also undoubtedly large. It is estimated that between 200,000 and
fense. However, the passage of the THO Act was not accompanied by 300,000 persons die of liver failure annually with about 25,000 of
government-­funded initiatives to advance development of deceased the deaths among patients who could have been transplant candi-
donor programs. Unsurprisingly, transplantation in India is predom- dates.8 In this perspective we review the current status and propose
inantly based on living donation. Today, India performs the highest national policies to advance deceased organ donor transplantation
number of living donor kidney and liver transplants in the world but in India. As the delivery of health-­care services in India is complex,
this viewpoint does not directly address implementation issues
Abbreviations: NOTTO, National Organ and Tissue Organization; THO, Transplantation which will vary between individual states in the country.
of Human Organs; USD, US Dollars.

© 2021 The American Society of Transplantation and the American Society of Transplant Surgeons

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2  |  CU R R E NT S TAT U S O F generated has been limited to the private sector and has not been
TR A N S PL A NTATI O N I N I N D I A leveraged to meet India's vast transplantation needs.
The available literature indicates strong public support for organ
There is a dramatic geographic variation in deceased organ donation donation in India.15,16 The paucity of deceased donations is because
and transplantation that is related to the state-­based organization the vast majority of potential donors are indigent motor vehicle ac-
9
of health-­care services in India. The deceased donations that take cident victims who are primarily treated in hospitals that lack the
place are largely due to the efforts of a few state governments, non- necessary infrastructure to support deceased donation. The con-
government organizations, and hospitals that are highly committed centration of transplant services and expertise in for profit private
to transplantation.10 The provision of health care in India is the re- hospitals focused on living donor kidney and liver transplantation
sponsibility of individual state governments. India's universal public-­ also indirectly limits the development of thoracic organ transplant
funded health-­care model aims to provide basic access to health services. As a result, those who cannot pay are likely never referred
care for its citizens free of charge. In reality this system is viewed for transplantation nor waitlisted resulting in instances where de-
as inadequate and inferior to the parallel private system which ceased donor hearts and lungs cannot be utilized because there is
provides the majority of health-­care services. With regard to the no identified waitlist candidate. Indian law permits foreigners to re-
public system, the national government is responsible for broadly ceived deceased donor transplants when there is no Indian waitlist
applicable issues such as prevention of major diseases, while state candidate, and a number of cases in the past of foreigners receiving
governments oversee hospitals and health-­care delivery. Interaction transplants in India have been reported in the lay press. The claim
between the national and state governments occurs for issues that that no Indian patient could be identified has fueled public distrust
require large-­scale resources or are determined to be of national that the system favors wealthy foreigners over Indians.
significance. In 2019, the Indian government committed US $21 The lack of deceased donor services is particularly troubling
million to the National Organ and Tissue Organization (NOTTO).1 because of the large potential number of deceased donors. There
Launched in 2014, NOTTO aims to work with existing regional-­and were over 150,000 fatalities due to road traffic accidents in India in
state-­level organizations to co-­ordinate interstate transplants. In ad- 2018 with the majority being young men who presumably would be
dition, NOTTO’s mandate includes establishment and implementa- suitable organ donors.17 Not surprisingly even small investments in
tion of protocols and guidelines, monitoring of transplant activity, deceased donor services have had significant impact. For example,
maintenance of a national organ and transplant registry, promotion in the state of Tamil Nadu, a dramatic increase in deceased dona-
of organ donation, and training of organ donation staff. tion and organ transplantations was achieved by establishment of
Ironically, states that perform the largest numbers of living donor deceased donation procedures, a central waiting list, education and
transplants are not necessarily leaders in deceased donor transplan- engagement of health professionals, and establishment of the so-­
tation. For example, the Union Territory of Delhi performed a total called green corridors to facilitate efficient transport of organs. With
of 21,471 organ transplants between 1995 and 2019; however, 97% these simple state government investments, Tamil Nadu had 1338
(20757) were living donor transplants.1 This disconnect between deceased donors, and performed 4712 lifesaving deceased donor
living and deceased donor activity is because transplant infrastruc- transplants from 2008 to 2019.9
ture and expertise is concentrated in private hospitals that oper-
ate revenue—­generating living donor transplant programs. Private
hospitals perform 90% of all organ transplants and 98% of all liver 3  |  W H AT C H A N G E S A R E N E E D E D?
transplants at a cost that is relatively low, approximately $ 7,500 US
dollars (USD) for a kidney transplant and $50,000 for a liver trans- The current system limits the health benefits of donated organs
plant, but still well beyond the reach of most Indians who have an to patients with the ability to pay and allows private hospitals to
average annual income of less than $2000 USD.11,12 profit without contributing much to the system. Poor Indians who
The advanced living donor infrastructure in India is increasingly donate organs have little or no hope of ever receiving lifesaving
accessed by foreigners, and private Indian hospitals are now the pre- transplants, and there is little investment in developing the neces-
ferred destination for transplantation among foreign patients with sary infrastructure and expertise to support deceased donation
a living donor but without timely or affordable access to transplant in government hospitals where most potential donors present for
services in their own country of residence. It has been estimated care. Although the available literature indicates strong public sup-
that in some private centers 25–­30% of all living donor kidney and port for deceased donation,15,16 there is growing discontent with
13,14
liver transplants involve foreigners. We estimate the national the disparity in access to transplantation between the rich and
proportion to be in the range of 15–­20%. Foreigners must pro- poor and with foreigners receiving deceased donor heart and lung
vide their own living donors (usually from their home country) and transplants. If poor Indians are to donate organs, they must have
there is a review process to reduce the risk of donor exploitation equal access to organ transplantation. It is not sufficient that do-
and transplant tourism. Although this activity may be justified be- nated organs are equally allocated to waitlisted patients in public
cause it provides lifesaving transplantation to people without access and private hospitals, if only wealthy individuals are ever wait-
in their home countries, the revenue, infrastructure, and expertise listed. The income-­related disparities in access to transplantation
SHROFF and GILL
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undermine public trust in the organ donation and transplantation only a limited mandate to facilitate interstate transplants, can ad-
system and jeopardize the advancement of deceased donor trans- dress the existing geographic disparities in deceased donor services.
plantation throughout the country. Therefore, it is imperative that The national organization would work with individual states to fund
policies to address the financial barriers to deceased donation and strategic regional infrastructure needs and to accredit hospitals to
transplantation are undertaken. perform deceased donations. This national entity would work with
Given the reality of a limited government health-­care budget, existing state organizations and transplant programs to train and
creative solutions are needed to fund the resources and infrastruc- employ a multidisciplinary team of health professional to ensure
ture necessary to support deceased donation. It is apparent that culturally sensitive end of life care to all potential donors and their
some Indian patients are able to pay for transplantation in private families and to ensure deceased donor service was provided in all
hospitals. These patients overwhelmingly obtain living donor trans- states according to international standards. Importantly the organi-
plants but could receive deceased donor transplants instead. It is zation would be responsible for allocation of deceased donor organs
short-­sighted to allow for profit hospitals to obtain deceased donor according to transparent allocation rules to ensure equitable access
organs to perform transplants while contributing little to the cost of to patients in need irrespective their place of residence, sex, religion,
deceased donor services. Currently private hospitals pay a nominal socioeconomic or social status.
organ maintenance fee to the donor hospital that is not standardized As India is now the preferred destination for foreigners with
between states. The implementation of a standardized organ acqui- their own living donors in need of transplantation, it is imperative
sition fee similar to that in the United States would generate nec- to implement policies to ensure this activity does not detract from
essary funds to help advance the development of deceased organ efforts to provide transplant services for Indians. Requiring private
donation services in the so-­
called nontransplant organ retrieval hospitals to pay a portion of the proceeds from such transplants into
centers. In parallel, safeguards would be needed to ensure patients the national system would accomplish this objective. A portion of
without the ability to pay received equitable access to transplanta- these funds might even be targeted to enhance living donor services
tion. This could be accomplished by implementing policies to ensure for Indian patients such as advancement of kidney-­paired donation
that every deceased donor transplant performed in a paying patient programs or to ensure living donors have access to long-­term post-­
would be matched by a transplant in a patient without the ability donation health care.19 Although deceased donor organs should be
to pay. To ensure capacity to perform deceased donor transplants prioritized for transplantation in Indian patients, a limited number
in poor patients, the government could incentivize private hospitals of deceased donor organs may reasonably be allocated to foreign
by waiving the organ acquisition fee for these transplants and by patients for humanitarian purposes with proceeds reinvested to ad-
linking the number of organs allocated to private hospitals for paying vance the Indian transplant system.
patients to the number of transplants performed in poor patients by Facilitating more transplants in poor patients will also require
the hospital. a government commitment to provide funding for long-­term post-
It is anticipated that private hospitals will decry a tithe on de- transplant care and immunosuppression. The availability of generic
ceased donor organs and argue that transplants will be too costly immunosuppressant drugs in India has reduced the average annual
for patients. Private hospitals could likely afford to pay a significant cost of posttransplant care including laboratory tests and physician
organ acquisition fee without sustaining a financial loss from de- care to between $1000 and $2000 USD. A policy decision on long-­
ceased donor transplantation because these transplants do not incur term government support for transplant care and immunosuppres-
the costs of living donor evaluation, surgery, and post-­donation care. sion is long overdue considering the Indian government announced
For example, state-­funded public transplant programs (i.e., Gujarat payment for chronic dialysis treatment in 2016 which will cost ap-
University of Transplantation Sciences, Ahmedabad) report patients proximately $6000 USD per patient per year. 20
costs of $5000 for deceased donor kidney transplantation and The solutions proposed in this viewpoint may not be acceptable
$10,000–­$15,000 for deceased donor liver transplantation.18 These by those who are well-­served by the status quo. The current sys-
costs are substantially lower than the amounts charged for living tem is a by-­product of the fact that donation and transplant services
donor transplantation in private hospitals (i.e., $7500 to $10,000 were virtually nonexistent only 25 years ago, and it was inevitable
for a living donor kidney and $50,000 for a living donor liver trans- that innovation would be restricted to the privileged few. The Indian
plant).11,12 It is also likely that paying Indian patients would be able to transplant community has achieved remarkable progress in the past
afford a somewhat higher cost for a deceased donor transplant as an 25 years; however, the resulting expertise and infrastructure must
alternative to having a family member serve as a living organ donor. now be leveraged for the benefit all Indians. The choice is clear, the
The proposed policy changes would encourage private hospitals to government of India must now take steps to provide equitable ac-
expand their current business model that is narrowly focused on liv- cess to transplantation for all Indians, or risk losing the critical sup-
ing donor transplantation for the wealthy to include deceased donor port of its citizens who are essential to advance the system.
transplantation for the benefit of all Indians.
The funds generated would be used to operate a national orga- AC K N OW L E D G M E N T
nization for deceased donation. The vast socioeconomic differences John Gill is funded by a Foundation Grant from the Canadian
between Indian states make it unrealistic that NOTTO, which has Institutes of Health Research
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2936     
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SHROFF and GILL

10. Abraham G, Reddy Y, Shroff S, et al. Evolution of deceased



D I S C LO S U R E donor transplantation in India with decline of commercial trans-
The authors of this manuscript have no conflicts of interest to dis- plantation: a lesson for developing countries. Kidney Int Suppl.
close as described by the American Journal of Transplantation. 2013;3:190-­194.
11. Khanna U. The economics of dialysis in India. Indian J Nephrol.
2009;19(1):1-­4.
DATA AVA I L A B I L I T Y S TAT E M E N T
12. Narasimhan G. Living donor liver transplantation in India.

No data will be made available Hepatobiliary Surg Nutr. 2016;5(2):127-­132.
13. Nagral S, Nanavati A, Nagral A. Liver Transplantation in India: at the
ORCID crossroads. J Clin Exp Hepatol. 2015;5(4):329-­3 40.
14. Foreigners seeking transplant must get family tree attested by high
John S. Gill  https://orcid.org/0000-0002-8837-6875
commission. The Times of India, 2016.
15. Poreddi V, Sunitha TS, Gandhi S, et al. Knowledge, attitude and
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