Legal Framework and Challenges of Organ Transplantation in India
Written by Roshin Iqbal
Fourth Year, BA LLB. Jamia Millia Islamia
Disclaimer: Please note that the views expressed below represent the opinions of the article's author. The following does not necessarily represent the views of Law & Order.
Organ transplantation is one of the exceptional achievements in modern medicine. It is the transfer of living tissue or organs to restore the health of the recipient. For the patients who are on the last stage of their disease, organ transplantation remains the last resort left for survival. At present, organs like heart, lung, kidney, liver, pancreas, ligaments, etc. can be transplanted. In India, the donation of organs from living and brain stem dead donors for transplant has been made legal under the Transplant of Human Organs Act, 1994. An amendment to the Act was passed by the Parliament in 2011 and Rules were enacted in 2014.
KINDS OF DONORS
1. Living Donor
The first category of donors is the living donors which include near-related donors, spousal donors, or other than near-related donors (everyone except near-related donors defined under section 2(i) of THOA,1994). Section 9(1)  authorizes such transplantation and the definition of near-relative is given under section 2 (i) of the Act. Near-related donors comprise parents, siblings, and children. By 2014 rules , grandparents have also been included in the list of near-related donors. For such donation, there shall be documentary evidence of the relationship. When the proposed transplant is between a married couple, documentary evidence like marriage certificate and marriage photograph are kept for record and a family photograph depicting the entire family and birth certificate of children.
Swap donation was included by 2014 rules. In swap donations, donors donate organs to strangers in exchange to get the best-matched organ for their near-relative. A PIL was filed in the year 2016 by Narmada Foundation at Bombay High Court requesting that the procedure to be followed in swap transplantation should be the same that is followed in case of near-related transplantations and not that of non-related transplants. Bombay High Court upheld that the issue of swap donation is open for consideration, however, the aggrieved person should approach the court for the same.
Other than near-related donors include everyone else like friends, uncles, aunts, cousins, etc. The provision related to it in section 9(3) of the THOA Act, 1994. This is the most controversial category as it gives ground to organ trading. There is a possibility of monetary transactions in case of a donation from a poor person to a rich recipient where the latter can coerce the former to donate his organ in exchange for a sum of money.
2. Deceased Donor
Sections 3-8 of the Transplantation of Human Organs Act, 1994 regulate deceased donation. As per section 3 , any person can at any time before his death, in the presence of two witnesses, authorize in writing the removal of any organ from his body. The act does not provide for presumed consent of organ donation.
Transplantation of Human Organs Act, 1994, for the first time recognized brain death as a moment of death for retrieval of organs. From 1994 onwards brain death donors have become a viable source for organ transplantation. Brain death is verified by a panel of four doctors, comprising of:
● Hospital administrator
● Resident doctor of the hospital
● Neurologist/ physician/ anaesthetist (added by 2014 Rules)
People may pledge anytime during their lifetime to donate their organs after death. In order to pledge one’s organs, they are required to adhere and fill Form no. 7 as provided under the TOHA Act, 1994. Despite the open declaration, consent, and one’s wish to donate his organs after his death, approval of the family is essential. Authorization for organ donation after brain death may be given before death by the person himself or by the person in legal possession of the body under Forms 8 and 9 as prescribed under the TOHA Act, 1994.
1. Advisory Committee
The Central Government and the State Government, as the case may be, by notification, shall constitute an Advisory Committee for a period of two years to aid and advise the Appropriate Authority to discharge its functions and shall comprise of one administrative expert not below the rank of Secretary to the State Government, to be nominated as Chairperson of the Advisory Committee two medical experts with a postgraduate medical degree with at least five years of expertise in the field of tissue and organ transplantation.
2. Appropriate Authority
All transplantations except related transplantation and foreign transplantations are assessed by authorization committees. It aims at the regulation of living donor transplantation and reviews each case to ensure that the donor is not monetarily exploited and to prevent commercial dealings in organ transplantation. It also inspects and grants registration to hospitals for transplantation, enforces required standards for hospitals, and conducts regular inspections of hospitals to examine the quality of transplantations.
3. Competent Authority
It is a committee constituted by the head of the institution/ hospital. Its members shall not be a part of the transplantation team. It can give permission to near-related donors only.
Any person aggrieved by the decision of the regulatory body may appeal to the state or central government within thirty days from receipt of orders.
ETHICS OF ORGAN SALE
In the present scenario, there is a widening gap between the middle class and the poor class, absence of healthcare insurance schemes for most of the population, delayed healthcare process, increase in technology, and yet not accessible to all. Business in organ donations seems to be a quick and attractive business for many and a solution to some. Organ trade in India is widespread, and just like prostitution, child labor, etc. is a serious socio-legal problem. It is a bitter reality that poor people are exploited and dragged into rackets by alluring them with monetary gains.
Organ sale, whether consensual or not, is prohibited by law. Criminalization of organ donation for profit-making purposes makes the bona fide donations of organs virtually impossible in India. However, the black market of organ rackets are still active in India.
The most abused part of the THOA, 1994 remains to be Section 9(3) under which the “non-related donors” could also donate their organs on approval by the Authorisation Committee owing to affection or love. An anthropologist from Berkeley named Lawrence Cohen interviewed some patients in India and learned through various researches that most of the donors were women whose husbands were badly in debt due to the habit of gambling, this led them to trade their organs for paying off those debts. 
WHO Committee on Morals and Ethics of Transplantation Society affirmed that the “sale of organs by donors living or dead is indefensible under any circumstances.” Principle 5 of Draft Guiding Principles on human organ transplantation reads as- “The human body and its parts cannot be the subject of commercial transactions. Accordingly, giving or receiving payment (including any other compensation or reward) for organs should be prohibited.”
There lies a clear gap between demand and supply of organs. As long as this gap is present, illegal methods of organ donation are sure to follow. The legal system is not enough to control this, certain measures which can be adapted to handle this situation are:
Firstly, the strategy of opt-out should be used instead of an opt-in approach. The opt-in approach is when the person expresses his will for removal of his organs for transplantation at the time of death or brain stem death. The opt-out approach is a method in which there is a presumed consent of a person to donate his organs for transplantation if he has the potential to do so. Anyone unwilling to donate may make an express statement for it. Currently, the opt-out approach is used in many countries like Denmark, Finland, France, Greece Italy, Norway, Spain, etc. This approach may curtail organ sales to some extent. Other methods include alternatives to organ transplantation such as xenotransplantation, artificial organs, tissue engineering, etc. could be undertaken.
“A pound of that same merchant’s flesh is thine; the law allows it, and the court awards it.”
The Merchant of Venice, Shakespeare.
The fact that the Act is filled with various limitations is indisputable. The situation in India is worse due to the prevailing social and religious antipathy to organ donation. The Act has neither curbed organ trading nor helped in the promotion of deceased organ donations. India’s potential for organ donation is huge due to the high rate of fatal road accidents which result in the death of the victims. Society must understand the fact that cadaver organs can be used to save the life of people and discard the notion about the inviolability of corpses that deter organ transplantation.
The only lasting answer is the “opt-out” system. Further, organ banks, like blood banks should be established to ease access to organs and prevent exploitation by middlemen. Considering a scenario like this, Davies writes, “As long as there are adequate safeguards, any legal or ethical fastidiousness demanding that donation be only gratuitous could condemn the sick.”
 Section 9(1) of the Transplant of Human Organs Act, 1994 .  Transplantation of Human Organs and Tissues Rules, 2014.  Transplantation of Human Organs Act, 1994.  Dr. Anju Vali Tikoo, Transplantation Of Human Organs: The Indian Scenario, ILI Law Review, Summer Issue 2017, Vol I, Pg. no. 151.  THO Amendment Act(2011).Transplantation of Human Organs (Amendment) Act 2011; The Gazette of India; part II; section 13A (1).  THO Amendment Act(2011).Transplantation of Human Organs (Amendment) Act 2011; The Gazette of India; part II; section 13A (2)(a).  THO Amendment Act(2011).Transplantation of Human Organs (Amendment) Act 2011; The Gazette of India; part II; section 13A (2)(b).  Sahay M. Transplantation of human organs and tissues Act-“Simplified”. Indian J Transplant 2018;12:84-9.  Sahay M. Transplantation of human organs and tissues Act-“Simplified”. Indian J Transplant 2018;12:84-9.  Sahay M. Transplantation of human organs and tissues Act-“Simplified”. Indian J Transplant 2018;12:85.  THOA (1994). Transplantation of Human Organs Act 1994. Central Act 42 of1994. The Gazette of India.  S. Carney, The Red Market (2011).  47(1) Bulletin of WHO 131 at 133 (1972).  Report, “Human Organ Transplantation” 42(3)/DHL 390 at 393 (1991).  DAVIES IWAN, “Live Donation Of Human Parts: A Case For Negotiability”, 59. Medico Legal Journal, 100 1991. BIBLIOGRAPHY
ACTS AND RULES :
1) Transplantation of Human Organs and Tissues Act,1994
2) Transplantation of Human Organs and Tissues Rules, 2014
1) Reeta Dar (Khashu) DR. Sunil Kumar Dar Legal Framework, Issues and Challenges of Living Organ Donation in India, IOSR Journal of Dental and Medical Sciences, .Volume 14, Issue 8 Ver. VIII (Aug. 2015), PP 59-66.
1) SCC Online