|Year : 2018 | Volume
| Issue : 3 | Page : 169-173
Legal aspects of transplantation in India
Sunny B Shah, Bharat Vallabhdas Shah
Department of Nephrology, Global Hospital, Mumbai, Maharashtra, India
|Date of Web Publication||28-Sep-2018|
Dr. Bharat Vallabhdas Shah
Room 209, 2nd Floor, Global Hospital, Parel, Mumbai - 400 012, Maharashtra
Source of Support: None, Conflict of Interest: None
The shortage of organ donors for patients with end-stage organ diseases requiring transplant is a global problem. This led to organ trafficking with exploitation of poor people who were made to sell their organs. To address the issue of organ trafficking and to ensure fair allocation of organs from cadaver donors, most countries have passed laws to regulate transplants. In India, the law (THE TRANSPLANTATION OF HUMAN ORGANS ACT, 1994) was passed in 1994 and the rules framed in 1995. The most important aspect of the Act was that it legalized brain-stem death as death allowing organs to be retrieved from brain-stem dead patients. Other important aspects of the Act include the following: (1) regulation of removal of organ/s for transplantation from cadaver donors, (2) regulation of removal of organ from living donors, (3) regulation of hospitals, (4) regulation of medical practitioners, and (5) punishment for those flouting the Act. The Act has significantly regulated living and cadaver donor transplant but made the process of obtaining approval for living donor transplant difficult even in genuine-related cases. Swap transplant or paired donation between related pairs is treated as unrelated donor transplant, making the process of obtaining approval very lengthy and tedious. For reasons that cannot be understood, although living unrelated transplant can be performed if there is no commercial dealing, swap transplant between unrelated pairs is not permitted. Punishment is harsh for anyone who contravenes any provision of the Act and unfortunately, transplant team doctors are made liable in most cases.
Keywords: Cadaver, legal, paired donation, swap, transplant
|How to cite this article:|
Shah SB, Shah BV. Legal aspects of transplantation in India. Indian J Transplant 2018;12:169-73
| Introduction|| |
In the early period, the biggest challenge to transplant was immunologically mediated graft rejection. With better understanding of the immunology of transplant, discovery of potent immunosuppressive drugs, and systematic approach to posttransplant infections, the results of transplant significantly improved. Then, the biggest challenge to transplant was the availability of organs. For a patient with kidney and liver failure, a living person could donate one of the two kidneys or a part of the liver. However, for lung and heart failure patients, living person could not donate and donation after death as defined earlier on the basis of cardiopulmonary criteria (irreversible cessation of circulatory and respiratory function) would not work as organs would have sustained irreversible ischemic injury.
In 1960s came the concept of brain death with use of organs of such brain-dead patients (cadavers) when they are on ventilators and their hearts continue to function. The continued circulation of blood helps to prevent irreversible ischemia of organs. Acceptance of brain-death concept increased the availability of organs and made those transplants possible which would not have been possible with living persons (heart, lung, intestine, etc.). However, it was difficult for many families to accept brain death when dealing with a tragic loss. Therefore, the wide gap between the need and availability of organs remained.
The organ shortage led to organ trafficking with exploitation of poor people who were made to sell their organs (particularly kidney) to wealthy patients with organ failure desperate for transplant.
To address the issue of organ trafficking and to ensure fair allocation of organs from cadaver donors, most countries have passed laws to regulate transplants. In the US, the National Organ Transplant Act was passed in 1984. In India, the law (THE TRANSPLANTATION OF HUMAN ORGANS ACT, 1994) was passed in 1994.
| Transplantation of Human Organs Act, 1994|| |
The most important aspect of the Act is that it legalized brain-stem death as death allowing organs to be retrieved from brain-stem dead patients. Other important aspects of the Act include the following:
- Regulation of removal of organ/s for transplantation from cadaver donors
- Regulation of removal of organ from living donors
- Regulation of hospitals
- Regulation of medical practitioners
- Punishment for those flouting the act.
| Regulation of Cadaver Donation|| |
Sections 3–8 of the Act regulate cadaver donation. As per Section 3 of the Act, any person can at any time, before his death, authorize in writing and in the presence of two or more witnesses, the removal of any organ of his body after his death. Form 7 of the Transplantation of Human Organs and Tissues Rules, 2014, provides for the format in which such an authorization is to be made. Now, such authorization can also be made in a driving license. In the event the person did not make such an authorization before his death, the person who is lawfully in possession of the dead body of such person can authorize the removal of any organ of the deceased person, unless he has reason to believe that any near relative of the deceased person has objection to the same. The Act does not provide for a presumed consent of organ donation from a deceased person (as in Spain) but instead requires an informed consent by the donor or the person lawfully in possession of the dead body.
As per Section 3(6) of the Act, cadaver donor organ donation requires certification of brain-stem death from a board of medical experts consisting of (i) registered medical practitioner in charge of the hospital in which brain stem death has occurred; (ii) an independent registered medical practitioner from a panel of names approved by the Appropriate Authority; (iii) a neurologist or a neurosurgeon; and (iv) registered medical practitioner treating the person whose brain-stem death has occurred.
| Regulation of Living Donation|| |
Section 9 of the Act regulates living donation. The Act provides for a separate procedure in case of living donation by near relatives and living donation by an unrelated donor. Section 2(i) defines a “near relative” to mean spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson, or granddaughter.
In case of living donation by near relatives, an application in Form 1 or 2 (depending on whether the donation is by spouses or other near relatives) along with Form 11 of the Transplantation of Human Organs and Tissues Rules, 2014, is required to be submitted to the competent authority (i.e., the head of the hospital where transplant is to be carried out or the committee constituted by the hospital, called Hospital Authorization Committee). The committee interviews recipient, donor, and their relatives and if satisfied, it gives approval for transplantation. The whole interview is video recorded.
In many states, if a patient or donor or both are not domicile of the state where transplant is to be performed, approval/NOC of the concerned State Authorization Committee is demanded (as per the Judgment of the Supreme Court of India, New Delhi in W. P. No. 156/05, dated March 31, 2005). The supreme court judgment was in case of unrelated donor transplant, but rule 6B of Transplantation of Human Organs (Amendment) rules, 2008, made it applicable even in related transplants. To clear the confusion, the Ministry of Health and Family Welfare issued a clarification on November 1, 2011, stating that “clause 6B of the Transplantation of Human Organs Rules, 2008 is applicable only for unrelated cases (and all foreigners) but not for the cases involving “near relative” “donor/recipient.” Despite this clarification, NOC of the concerned State Authorization Committee would be demanded if donor and/or recipient were from a different state. One of the authors (BS) filed a Public Interest Litigation (PIL) in Bombay high court, and now NOC from concerned states is no more insisted in case of related transplants [Figure 1].
|Figure 1: State agreed to not insist no objection certificate from other states in case of related transplants|
Click here to view
While the role of the Authorization Committee is only to look into relationship between the recipient and the donor and not the medical aspects of transplantation, at times the committee interferes in the medical aspects.
In one case, a 25-year-old young man with end-stage kidney disease had a sibling (HLA identical sister) as the only potential donor from the family. On evaluation, she had a stone in the right upper ureter with mild-to-moderate hydronephrosis. Rest of the donor evaluation was normal. The case was discussed jointly with the donor and recipient surgeon and it was decided that being the only potential donor, she should be accepted after treatment for the right upper ureteric stone with extracorporeal short wave lithotripsy (ESWL). Once the stone was removed, the application was submitted to the hospital committee with all requisite documents including the psychiatrist's evaluation of the donor. Despite two psychiatric opinions, hospital denied permission on the grounds of low IQ of the donor. The family went to the court. The court on interviewing the donor also felt that she was able to understand the risks and benefits of kidney donation and forwarded the papers to the State Committee. The State Committee brought up the issue of right ureteric stone and whether the donor was medically suitable (which authors feel is not in their purview). Nevertheless, an affidavit was filed by the doctor and court passed an order in favor of the patient.
In case of living donation by an unrelated donor, an application in Form 3 along with Form 11 of the Transplantation of Human Organs and Tissues Rules, 2014, is required to be submitted to the Hospital Authorization Committee as in case of related transplants. The Hospital Authorization Committee will scrutinize the application and interview the donor, the recipient, and their relatives to satisfy itself that there is no commercial dealing involved between the donor and the recipient. The application will then be forwarded to State Authorization Committee which will again scrutinize the application and interview the donor, the recipient, and their relatives. This interview is also video recorded. Thus, there is a two-level check in case of unrelated donors.
If, after interviewing recipient, donor, and their relatives, the Authorization Committee feels that the applicants have not complied with the requirements of this Act and the rules made thereunder, it shall, for reasons to be recorded in writing, reject the application for approval. In practice, the reason for rejection of application is not given in writing. Patients should be guided to demand in writing the reason if their applications are not approved.
In cases where there is a pair of donor and recipient who are near relatives, but the donor is unable to donate his organ to the recipient due to biological incompatibility, and there is another related pair with a similar issue, but the donor of the first pair is biologically compatible with the recipient of the second pair and the donor of the second pair is biologically compatible with the recipient of the first pair, the Act permits a swap transplant or a paired transplant, wherein the donor of the first pair donates his organ to the recipient of the second pair and the donor of the second pair donates his organ to the recipient of the first pair. The process of obtaining approval in case of such swap transplant or paired transplant is as in unrelated transplant. This seems inappropriate because it takes a very long time when recipient and/or donor belong to different states and require NOC from the State Authorization Committee of their state. The long delay in the process at times can cost the life of the patient.
The author (BS) was working up the swap transplant where one recipient–donor group (spouses) was from Gujarat and another group (daughter–mother) from two different states – the daughter was from Rajasthan and mother from Haryana. They had to get verification from three states (Gujarat, Rajasthan, and Haryana) to get transplant done in Mumbai. The whole exercise took 7 months.
A PIL was filed by the Narmada Kidney Foundation in 2016 in the Bombay High Court requesting that the procedure to be followed in case of swap transplant should be akin to that followed in case of near relative transplant (when swap transplant is between related pairs) and not as is followed in case of an unrelated transplant. The Bombay High Court, however, was not inclined to entertain this issue at the behest of an NGO and left the issue open to be considered as and when an aggrieved person/patient approaches the court.
The authors also cannot understand why swap between unrelated pairs is not allowed when the Act clearly permits unrelated transplant if there is emotional relationship and no commercial dealing. For example, if there is a pair, where uncle (considered unrelated as per the Act) wants to donate to nephew but cannot do so due to biological incompatibility, and there is another similar uncle–nephew pair with a similar issue, but the donor of the first pair is biologically compatible with the recipient of the second pair and the donor of the second pair is biologically compatible with the recipient of the first pair, the swap transplant cannot be performed. Such transplants actually save money as well as lives.
Bingaman et al. reported how kidney paired donation (swap transplant) significantly increased the number of live-donor kidney transplants at their center. According to the authors, paired donation program could potentially result in approximately 2000 additional live-donor transplantations annually and reduces the number of patients on the waiting list. The increased use of this procedure would also probably avert many difficult and expensive desensitization therapies.
In the United States, a chain of kidney transplants was performed linking thirty unrelated people who were willing to give up an organ with 30 who might have died without one. What made the domino chain of sixty operations possible was the willingness of a Good Samaritan, Mr. Ruzzamenti, to give the initial kidney, expecting nothing in return. Its momentum was then fueled by a mix of selflessness and self-interest among donors who gave a kidney to a stranger after learning they could not donate to a loved one because of incompatible blood types or antibodies. Their loved ones, in turn, were offered compatible kidneys as part of the exchange.
| Regulation of “Hospitals” and “Human Organ Retrieval Centres”|| |
Section 10 and Section 14 of the Act provide that no hospital or Human Organ Retrieval Centre shall commence any activity relating to removal, storage, or transplantation of any human organ or tissue unless such hospital is registered under the Act.
For registration of a hospital as a transplant center under the Act, the hospital is required to be in a position to provide such specialized services and facilities, possess such skilled manpower and equipment, and maintain such standards as may be prescribed from time to time. For registration of a hospital as a Human Organ Retrieval Centre under the Act, the hospital is required to have Intensive Care Unit facilities along with manpower, infrastructure, and equipment as required to diagnose and maintain the brain-stem dead person.
Section 13 of the Act provides for the establishment of an Appropriate Authority, which has been given the functions to grant certificate of registration to a hospital under the Act. The Appropriate Authority has also been given the power to suspend or cancel the license of the hospital, if the hospital is found to breach the provisions of the Act.
| Regulation of Medical Practitioners|| |
As per Section 3(4) of the Act, only a registered medical practitioner can remove an organ from a human body and the registered medical practitioner can conduct transplantation only in a hospital registered under the Act. A medical practitioner does not need a separate registration under the Act. Section 2(n) of the Act defines a “registered medical practitioner” to mean a medical practitioner who possesses any recognized medical qualification as defined in clause (h) of Section 2 of the Indian Medical Council Act, 1956 (5) and who is enrolled on a State Medical Register as defined in clause (k) of that section. The Act prescribes various duties of a medical practitioner and also punishment for breach of those duties.
In case of cadaver donation, the registered medical practitioner has to satisfy himself that the donor has been certified as brain-stem dead as described above.
When potential cadaver donor is <18 years of age, any of the parents of the deceased person may give authority for the removal of any human organ from the body of the deceased person.
In case of living donation, the registered medical practitioner has to explain all possible effects, complications, and hazards connected with the removal and transplantation to the donor and recipient, respectively, before undertaking the removal or transplantation of any human organ.
| Punishment under the Act|| |
As per Section 18 of the Act, any person involved in removal of any human organs without authority can be punished with imprisonment for a term which may extend to 10 years and with fine which may extend to Rs. 20 lakhs. If that person is a registered medical practitioner who is convicted, his name shall be reported by the Appropriate Authority to the respective State Medical Council for taking necessary action including removal of his name from the register of the Council for a period of 3 years for the first offense and permanently for the subsequent offense.
As per Section 19 of the Act, any person involved in commercial dealing in human organs can be punished with imprisonment for a term which shall be not less than 5 years but which may extend to 10 years and shall be liable to fine which shall not be less than Rs. 20 lakhs but may extend to Rs. 1 crore.
As per Section 20 of the Act, any person who contravenes any other provision of the Act can be punished with imprisonment for a term which may extend to 5 years or with fine which may extend to Rs. 20 lakhs.
It is unfortunate that when anything goes wrong with the legal aspects of transplant, it is the doctors who are considered responsible. In July 2016, a kidney transplant was stopped midway when it was realized that an unrelated donor transplant was being performed as related donor transplant. The police arrested doctors of the transplant team, medical director, and CEO of the hospital using TOHA sections 12 ('no registered medical practitioner shall undertake the removal or transplantation of any human organ unless he has explained, in such manner as may be prescribed, all possible effects, complications, and hazards connected with the removal and transplantation to the donor and the recipient, respectively') and section 21 ('The Act has been committed by a company and it is proved that the offense has been committed with the consent or connivance of, or is attributable to any neglect on the part of, any director, manager, secretary, or other officer of the company. Such director, manager, secretary, or other officer shall also be deemed to be guilty of that offense and shall be liable to be proceeded against and punished accordingly').
The authors wonder that when there is an elaborate process to obtain approval for transplant why are the doctors made liable? There is a hospital committee (and in case of unrelated transplant a state committee also) meant to verify all the documents submitted by the recipient and donor to establish the identity and relationship between recipient and donor. Then the recipient, the donor, and their relatives are interviewed by these committees. The whole process is video recorded. If there is such an extensive process, why are transplant doctors made responsible? Moreover, should the doctor be verifying the documents or concentrating in management of the patient?
In summary, Transplantation of Human Organs Act, 1994, was a significant advance in the field of organ transplant in India. Most importantly, it legalized brain-stem death, making cadaver donor transplant possible. The Act has significantly regulated living donor transplant but made the process of obtaining approval difficult even in genuine cases. Punishment is harsh for anyone who contravenes any provision of the Act and unfortunately, transplant team doctors are made liable in most cases.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |