in India Neelma Devi Assistant Professor, Amity Law School, Amity University, Noida

ransplantation of human organs Brain –Stem death both by natural and manmade According to black’s Law Dictionary meaning Tsubstitution is a landmark in curative of death is “the cessation of life: the ceasing to techniques in the field of science and exit, defined by physicians as total stoppage technology. Successful transplantation of of the circulation of blood: and the cessation human , and besides of the animal and vital function consequent saving the lives of hopeless patients have thereon: such respiration, pulsation etc”.2 The led to certain complex problems of religion registration of birth and death Act, 1969, says , ethical, philosophical , moral, legal, that death means “the permanent disappearance 1 political and economically nature . Organ of all evidence of life at any time after live birth transplantation is the procedure of replacing has taken place.”3 The Indian Penal Code, 1860 diseased organs, parts of organs, or tissues has another by healthy organs or tissues. The Resource of organ may be living or deceased donor. In this perceptive regarding the definition of death. era of science and technology it is common As per section 46 of Indian Penal Code defines 4 procedure used in medical science throughout the death as death of human being” . There the world. Human helps is no well defined definition of death and also us in two ways. It provides the possibility of does not gives us ideas about Brain-stem saving of life and secondly it provides the best Death. There is classical definition of death. result in term of quality of life and reduces the As per that definition death means cessation long term costs. Transplantation of of three independent vital body functions- human organ is best and reliable therapies in circulation, respiration and brain activity. comparison to the dialysis. In case of dialysis Cessation of breathing and loss of heart beat it is time consuming and as well as costly. are still viewed by many as crucial death signs. Due to organ transplantation thousand of life Notion is that the death is not exclusively have been saved and improved the health of associated with breathing and heart beat. thousands of people. In spite of all these facts, Transplantation of Human Organ Act, 1994 regrettably many people will not benefit from defines death as stage at which all functions this therapeutic procedure. There is shortage of the brain stems have permanently and of organ donors all over the world. Shortage irreversibly ceased and is so certified by board 5 of human organ is due to unawareness, weak of Medical Experts. It is difficult to convince legal frame work, lack of uniform legal frame the family member about the concept of Brain work regarding transplantation of human death even after telling them about patients’ organ. In some countries it is very tough Brain death there are not ready to give up and task to get government permission for the go through with ventilator process. There is human organ transplantation like USA. In no legal section for disconnecting life support, other hand some countries like Iraq human including the ventilator. This has led to organ transplantation is a recognized as a commercial transactions. Human organ is 2. “Black’s Law Disctionary (1950) p.488 treated as a property of human being. 3. Section 2(b) of the Registration of Birth and death Act,1969 4. Section 46 of The Indian Penal Code Act, 1860 1. C. Manickam, “Organ transplantation and the Law”, 5. Section 2 of The Transplafntation of Human Organ cochin University law review, 1995 pp.176. Act, 1994 47 Organ Donation in India major ethical predicament on the ground. The person. Transplantation from the dead person family is informed that relative is dead and also avoids so many issues which might be asked for consent for donation. But if they related to ethical as well as commercialization refuse and request that the body be handed of the organs. Consent of the diseased person over, their request to withdraw life support is and proper authorization committees is the turned down. 6 Thus the declaration of brain main legal issues related to the cadaver death is not possible in every hospitals exept donor. Now the question is that can a healthy where the Transplantation of Human organ person by will donate his organ? In Williams take place. This led to bizarre situation where vs. Williams9 the court of appeal in England the cadaver donor had to be shifted to another held that a person cannot by ‘will ‘or otherwise recognized institution only for the purpose of dispose of his body after death and that any organ retrieval. The question of whether brain directions given by him are not binding on his death can be declared independent of organ personal representatives and survivors. The donation is still an open question. In reality court said “there is no property in or ownership brain death individuals are still hooked of dead body that man cannot by will dispose on the intensive organ support measures.7 of his dead body.10 According to the instruction Being a developing nation we have scarcity of given by a person who died, as to the disposal Intensive care unit in India. As because of this of his body, could be therefore disregarded by fact we are not able to provide this intensive his personal representatives. However, the Care unit facility to all. advancement in medical technology and the Recognition of Cadaver Transplantation elt need for human parts for research and or tissue donation The removal of organ therapeutic purposes changed the traditional from the dead body raises the moral question trend. and whether commercialization of organ By a living person under express can be allowed. Organs transplantation is Authority- primarily intended to protect the interest According to Sub section (1) of section 3 of of recipients. But there are three categories Transplantation of Human Organ Act, 1994 of people involved in this-the physician, the any donor may, in such manner and subject donor, the recipients and the relatives and to such conditions as may be prescribed, dependents of the donor and recipients. The authorize the removal, before his death, of balancing of conflicting interest of these people any human organ of his body for therapeutic is a complex question. The consent to donate purpose11According to Section 3(2) of the organ cannot, in most cases, be a free consent. Transplantation of human Organ Act, The financial condition of donor may have an 1994 “if any donor had, in writing and in the influence on him.8 Due to the technological presence of two or more witnesses (at least and medical advancement in India now the one whom is a near relative of such person) value of cadavers has gone up because of its unequivocally authorized at any time before beneficial use of its part of transplantation. his death, removal of any human organ of his After the invention of brain death concept it is body, after his death, for therapeutic purposes, now easy to obtain an organ from the diseased the donor shall, unless he has any reason to believe that the donor had subsequently 6. Nagral Sanjay, Amalorpavanathan J, “deceased organ revoked the authority aforesaid , grant to a Donation in India: where do we go from here?, Indian registered medical practitioner all reasonable Journal of Medical ethicsVol.XI No.3 July September p.164 7. Panday Sk;,”Brain death and our transplant law’”, 9. (1882) 20 Ch.D 659 Issues Medical Ethiscs. 2001 p.51 10. ibid 8. Mahalswar K.P.S”Medical Negligence and The Law 11. Sub Section (1) of Section of Transplantation of 1991 p.g 156 Human Organ Act, 1994. 48 Organ Donation in India facilities for the organ removal, for therapeutic restricted mostly to two organs-one kidney or purposes, of that human organ from the dead apart of liver only. 12 body of the donor” It means an adult who is Living/ Cadaveric organ or issue donation sound mind can express his desire to donate organs through will and after the death; his There are two type of living donors who can organs can be removed for Transplantation. donate organs- When authorities reasonable believe that the 1. Known Organ Donor deceased had not expressed any objection, his a. Near Related organ Donors organ can be removed with the approval of near relatives. According to Sub clause 3 of b. Other than Near Relatives section 3 says that where no such authority 2. Unknown Organ Donors as is referred to in sub section (2) of Section 3 of the Transplantation of Human Organ Act, a. Purely Altruistic donors 1994, was made by any person before his death b. Quasi-altruistic donor but no objection was also expressed by such c. Non –altruistic donors person to any of his human organs being used after his death for the therapeutic purposes, 1. Known Organ Donors- this category the person lawfully in the possession of the of organ donors are always known to the dead body of such person may, unless he recipient- either through biological or long has reason to believe that any near relative –existing social relationship. Such donors of deceased person has objection to any of share a bond of love and affection with deceased person’s human organs being used the recipient. They share organs to save for therapeutic purposes, authorize the the life of their loved one. However the removal of any human organ of the deceased lot of document is required by ‘competent person for its use of therapeutic purposes. authority’/ authorization committee to authenticate. Live Donors-living organ donors are those donors who donate organ like one a. Near Related Organ Donor- As kidney, a part of or part of per Transplantation of Human to an ailing person for his/her therapeutic Organ and tissue rules, 2014, the benefits during life. In India donation of transplant of organ is permitted organs from living as well as brain death between near relatives like spouse , stem dead donors for transplantation into mother, father, brother, sister, son, patients for therapeutic purpose was made daughter, grandfather, grandmother legal under the Transplantation of Human and grandchildren after approval by Organs Act, 1994.13 The Act was amended in Competent authority. The Competent 2011 that legalized swap transplants among Authority ensures that donor- compatible living donor and recipients pairs recipient relationship is genuine and under Transplantation of Human Organ there is no coercion or pressure on the Act, 201114which was followed by Gazette donor. notification of Transplantation of Human b. Other Near Relatives: - In India Organ and tissue Amendment rules, 2014. , organ donation by other than near However, organ donation from living donor is relatives like friends , uncles ,aunts , cousins etc. is also permitted but only 12. Section 3 of The Transplantation of Human Organ after approval by the “Authorization Act, 1994. Committee” of the hospital, a district 13. Sub Section 1 of section 3 of the Transplantation of or hospital. human Organ Act, 1994. 14. Section 1 of the Transplantation of Human Organ Amendment Act,2011. 49 Organ Donation in India

Table 1. Showing requirement of various Table No.2 Depicting Form Numbers and document and their purpose for facilitating purpose of these forms for facilitating living donation and Transplantation as per living organ donation and transplantation Transplantation of Human Organ Rules, 2014 as per Transplantation of Human Organ Rules 2014 S. Documents Required Purpose of the No Document S. Number Purpose of To Be filled By 1 Ration Card or Pan or For identity and No Form Aadhaar card or Voter proof of resi- 1 Form 1 For organ Do- Living related Identity card or Pass- dence nation From donor word. Living near 2 Birth Certificate, Mar- For ensuring ex- related Donor riage Certificate, other istence of Rela- 2 Form 2 For organ do- Living spousal relationship Certificate tionship among nation from Donor from Tehsildar or, sub Indians. living spousal divisional Magistrate donor Or Metropolitan Mag- 3 Form 3 For organ do- Living known” istrate or Sapanch. nation from other than 3 Relationship certifi- For ensuring ex- “other than near relative” cate to be certified by istence of rela- near relative” donor. senior embassy as per tionship of fore- donor Form no. 21 ing nationals 4 Form 4 For the Certif- Registered having embassy icate of Medi- Medical prac- in India cal fitness of titioner 4 Relationship Certifi- For Ensuring living donor cate’ to be certified by existence of re- 5 Form 5 For certificate Head of pa- Govt. of that Country lationship of for- of genetic re- thology certi- to which the foreigner eign nationals lationship of fying relation- belongs as per form 21 not having em- living donor ship. bassy in India with recipi- ent. The Authorization committee is supposed to meet 6 Form 6 For Spousal “Competent regularly to Scrutinize application for organ dona- living donor authority” in tion. Its work involves ensuring that living donor case of Indian is doing the deed purely out of love and affection nationals and for the recipient. This is done through personal by “Authori- interviewer of the donor, recipients and members zation Com- of their families. Such interviews are recorded on mittee” in case video. The Indian System is very cautions in giv- of foreigners ing a stamp of approval to donor recipient tie-up after verifying due to gross social and economic equalities, ab- the marriage sence of national health insurance policy and re- through docu- ported cases.15 mentary evi- dence. 15. Dr.Reeta Dar (Khashu), Dr. Sunil Kumar Dar, Legal Framework, issues and challenges of living Donation In India, Volume 14, Issue 8, ‘’ver VIII(Aug 2015) pp 59-66.available on www.iosrjournals.org. 50 Organ Donation in India

S. Number Purpose of To Be filled By 2. Unknown Organ Donor- these are the No Form donors who are unknown to the recipient. The two do not share any bond of love. 7 Form 7 Application Jointly by pro- for Approval posed recipi- a. Purely altruistic donors-Many of Transplan- ent and pro- people donate organs to stranger tation from posed donor. in response to their appeals in living donor. print or electronic media; others donote to anyone on waiting list 8 Form 8 Certificate by The “Autho- or initiate a domino chain of organ the Authori- rization Com- donation.16 zation Com- mittee” where mittee of hos- Transplan- b. Quasi Altruistic Organ Donors- pital, district tation has to A quasi altruistic donor donates or state take place ( to an organ after receiving the same be issued on organ either from a living donor letter head) or a deceased donor. Such kind 9 Form 9 Certificate by “Competent of quasi –altruistic organ donors “ competent Authority” are usually heart or liver domino Authority” in donors. The qausi –altruistic case of near domino liver donates his liver to relative other another recipient after getting a than spousal part of liver either from a living donation donor or from a deceased donor. In these cases the donor gets a chance 10 Form 10 Verification Tehsildar or to become a recipients and donor certificate in other autho- simultaneously.17 respect of do- rized officer micile status required only c. Non –Altruistic organ donors- of recipient or for donor oth- In this Category the donor donor er than near unknown to the recipient. relative / re- Donors donate organ to stranger cipients if in exchange for getting the best they do not matched organ for their own belong to state relatives or friends to whom they where trans- intend to donate organs.18 This plant hospital type of Transplant is called swap identified for transplant. operation is it is important to note that no hospital or identified. institution can perform organ retrieval and 11 Form 11 Certificate of Embassy Con- transplant surgeries without getting a license relationship cerned Person. from “ appropriate Authority” that is constituted between do- by the state Government. nor and recip- ient in case of foreigner 16. Dar Reeta, Swap and domino Transplant transgressing socio-cultural and political boundaries, international Journal interdisciplinary Research and Innovation 3(1) pp.84-89. 17. Ibids 18. ibid 51 Organ Donation in India

Table No.:- Showing number and purpose a reasonable enquiry the authorities are un- of various forms for obtaining license by able to locate near relatives within forty-eight organ Transplantation/ retrieval hospitals hours. Organs must from cadaver be obtained from the “Appropriate Authority” in very soon after death: they may however, subse- accordance with Transplantation of quently be preserved for some hours by cooling Human Organs and Tissue Rules 2014 and other procedures. The Time factor in Trans- plantation of human Organ Act, 1994 diffuses S.No Form Purpose of the Form the transplantation purpose, because most of Number vital organs need to be transplantation purpose 1 Form 12 Application for registra- most of the vital organs needs to be transplant- tion of hospital to carry ed from cadaver very soon after the death. These out organ or tissue trans- provisions shall be understood as removal of an plantation other than organ for transplantation. Various Authorities cornea. under Transplantation of Human Organ Act, 2 Form 13 Application for registra- 1994 for the Removal and transplantation of tion of hospital to carry human organ out organ or tissue re- trieval other than cornea ● Appropriate Authority- To give a retrieval. grant registration to hospitals for the transplantation and removal of organ and 3 Form 16 Certificate of Registra- tissues there are certain standards for tion for ‘performing or- the hospitals. Appropriate Authority do gan/ tissue Transplan- inspections and investigations regarding tation and/ or tissue such standard and make inquiry after banking/ receiving any complaint regarding the 4 Form 17 Certificate of renewal of breach of such standard.20 Registration. ● Advisory Committee- Advisory The Act also provides the provision and proce- committees’ main function is to give advice dure regarding removal of human organs, in to the appropriate Authority regarding case of unclaimed bodies in the hospital and hospitals standard and necessary prison. There is a separate authority Authori- equipments and facilities, Facilities like ty for removal of human Organs, in case of un- intensive care units etc.21 claimed bodies in hospital or prison ● Authorization Committee- The main functions of Authorization Committee is “In the case of dead body lying in the hospital or to review each case regarding living donor. prison and not claimed by any of the relatives To do strict scrutiny about the living donor of deceased person within forty-eight hours free consent. And ensure that whether from the time of death of concerned person, the the donor is subject to exploitation or not. authority for the removal of any human organ To know the fact that whether there is from the dead body which so remains unclaimed commercial transaction in between donor may be given, in the prescribed from, by the per- and donees or not to avoid commercial son in charge, for the time being , of the man- activities. All proceeding of Authorization agement or control of the hospital or prison, or committee is videographer and gives by an employee of such hospital or prison au- thorized in this behalf by the person in charge of the management or control thereof.19” If on 20. Section 13 of Transplantation of Human Organ Act, 1994. 19. Sub Section 1 of Secction 5 of the Transplantation of 21. Rule 30 of the Transplantation of Human Organ Rule( human Organ Act, 1994 Amendment)2014 52 Organ Donation in India

decision with 24 hour. And the person other bigger issue is the scarcity of organ donor. who is not agree with Authorization There are so many organs which can be donated Committee’s decision can file seek justice by the person after natural death of the person from State or Centre.22 but there are religious sentiment of the people Current Scenario of Organ Donation in because of that on one is ready to donate their India- organ even after the death. Consent of the person is also again an issue for organ donation Years 2013 2014 2015 2016 2017 because consent might be given by the person Total 313 411 573 772 905 under pressure or any other reason. Availability Number of donor is the main problem in India. Lack of of donors institutional frame work, unawareness among people and improper infrastructural facilities Source-National Organ and tissues transplantation are the factors for the low rate of organ donation Orgnisations23 in India. Specially there are so many social There is huge gap between demand and supply and cultural myths regarding cadaveric organ of Organ in India. As per sources last five year donations. Administrative complexity and organ donation rate is 594 donors per years. And conservative mind set of the peoples also the demand is very high even 4 lakh people are dying reason for low rate of organ donation in India. due to waiting for the transplantation of organ. The Indian law enables authorities of hospitals The scarcity of organ is the main reason for theirs or jails where the person dies to allow removal death. The data show that how much important by registered medical Practitioner. According to organ donations in India. Organ Transplantation section 3 of Transplantation of Human organ is one of the revolutionary steps in the area of Act, 1994 the authority given under sub section Medical Science. The most of the people think I or sub section 2 of section 3 shall be sufficient that technological development in the area of warrant for the removal, for therapeutic Organ Transplantation is one of the greatest purposes, of the human organ: but no such achievements of the modern medical science. It removal shall be made by any person other than is advancement in the fields of which the registered medical practitioner.24 Majority contributed tremendous improvement in world of the patients have a premature death due to wide. The human organ transplantation has non –availability of suitable human organs. To raised so many ethical, social, economic and meet the constraint new areas of procurement religious controversies in India as well as in of organs have to be found. Organs of criminal the world. Trading of Organ is very common condemned to capital punishment can be used to in Asian nations, due to this Medical Tourism prolong the life of the patients who are in need has been growing day by day. The People from of them subject to convict’s consent. For this all over world come here to get an organ donor purpose, it was suggested that existing mode of at the cost of some money. The poor person and execution of death sentence as prescribed by the the venerable section of the society are victim of law be changed.25 Code of Criminal Procedure, these organ sales. In India there is proper law 1973 says that a person sentenced to death shall for the Organ Transplantation even after that be hanged.26 According to this section when any in the name of fiduciary relationship people person is sentenced to death the sentence shall used to sale there organ to other person. Apart be direct that he be hanged by the neck till he from commercialization of the organ donation

24. Sub section 4 of section 3 of the Transplantation of 22. Clause (a) and clause (b) of Sub Section 4 of the Section Human Organ Act, 1994. 9 of the Transplantation of Human Organ Act, 1994 25. Dhingra Indu”Gift of Life from the dead” Indian th 23. https://notto.gov.in/ accessed on 30 of November at Express, March 1995 p.8 1:40 PM 26. Secttion 354(5) of Criminal Procedure Code act, 1973 53 Organ Donation in India is dead. Deena V.Union of India27the Supreme The Asian Society of Transplantation. In 1987 Court approved the validity of the provision and the fortieth World Health Assembly, concerned at expressed its view as follows: “the act of hanging the trade for profit in human organs, initiated the causes the least pain imaginable on account of preparation of the first WHO Guiding Principles the fact that death supervenes instantaneously on Transplantation, endorsed by the Assembly the conclusion that the system of hanging is a in 1991 in resolution. These Guiding Principles painless as is possible in the circumstances. A have greatly influenced professional codes and question arise whether a convict sentenced a practices as well as legislation around the world death can be permitted to donate his organs if he during almost two decades. After a consultation wants to do so for the benefit of others. His last process that took several years, the Sixty-third wish is always respected. If it is his last wish, he World Health Assembly adopted resolution, will have to be permitted to donate organs. This endorsing the updated WHO Guiding Principles leads to another question as to how his life is to and identifying areas of progress to optimize be terminated. Death by hanging may not help donation and transplantation practices. Organ procuring the organ in the healthy condition donation and transplant rates vary widely across the globe, but there remains an almost universal Conclusion shortage of deceased donors. The unmet need Due to organ transplantation thousand of life for transplants has resulted in many systematic have been saved and improved the health of approaches to increase donor rates, but there thousands of people. In spite of all these facts, have also been practices that have crossed the regrettably many people will not benefit from boundaries of legal and ethical acceptability. this therapeutic procedure. There is shortage Recent years have seen intense interest from of organ donors all over the world. Shortage of international political organizations, led by the human organ is due to unawareness, weak legal World Health Organization, and professional frame work, lack of uniform legal frame work bodies, led by The Transplantation Society. regarding transplantation of human organ. Their efforts have focused on the development In some countries it is very duff task to get of a series of legal and ethical frameworks, government permission for the human organ designed to encourage all countries to eradicate transplantation like USA. In other hand some unacceptable practices while introducing countries like Iraq human organ transplantation programmers’ that strive to achieve national or is a recognized as a commercial transactions. regional self-sufficiency in meeting the need for Human organ is treated as a property of human organ transplants. These programmes should being. In last 5o years transplantation has seek to reduce both the need for transplantation become a successful worldwide practice. Legal and also develop deceased donation to its tools are a necessity in to maximum potential. Living donation remains allow transplant surgeons to remove organs the mainstay of transplantation in many parts from potential sources. In the area of organ of the world, and many of the controversial—and transplantation majorly two organizations is unacceptable—areas of practice are found in the operational like World Health Organization, exploitation of living donors.

27. A.I.R 1983 S.C 1155 at p.1186 54