With multiple health issues arising in the present times, the need for transplantation of Organs is rising. The primary legislation governing organ donation and transplantation in India is the Transplantation of Human Organs Act, (THOTA) which was passed in 1994. The Act majorly regulates the removal, storage, and transplantation of human organs for therapeutic purposes and to prevent commercial dealings in human organs.
This Article will in brief provide is governed and regulated by the government. This Act involves the detailed provisions relating to the authority for removal of human organs, preservation of human organs, regulation of hospitals conducting the removal, storage, or transplantation of human organs, functions of the appropriate authority, registration of hospitals, and punishment/penalties for offenses relating to aforesaid matters. In order to be aware citizens, we should be well versed with the legal procedures involved in this Act and avoid any inconsistency with the provisions
THOTA Rules, 2014 were introduced. In these rules, there is the further definitions of certain terminologies and the introduction of 21 forms, which are mandatory for live/deceased donor submission to the authorization committee. Procedure for near relatives and for other than near relatives, qualifications for transplant coordinator, details and process of establishment, and maintenance of organ registry have been defined in these rules.
Regulation of hospitals
This Act prescribes a manner for registration of a hospital which wants to get involved in organ transplantation for therapeutic purpose. It has to be done with the appropriate authority along with the due payment of fees. This Appropriate authority is appointed by the state government and has the power to grant/renew/suspend/cancel registration in order to enforce the standards. No hospital is registered unless the appropriate authority is satisfied. The tissue bank should also be registered. The Appropriate authority issues a certificate of registration to the respective hospital “tissue bank” which has to be renewed on payment of fees. In case of lack of meeting up to the requirements, appropriate authority can cancel/ suspend the registration of hospital/tissue bank with notice or even without notice in case of issue of public interest. A provision for appeal by the aggrieved group is available within 30 days of receipt of the order (Chapter v of the Act, section 14, 14A, 15, 16, 17). The following requirements need to be met for fulfilling the registration under Rule 26, THOTA 2014 :
- There should be 24-hour availability of medical, surgical, nursing staff, ICU units with equipment, staff, blood bank, laboratory services, operation theatre, experts of specialty, HLA lab, communication systems.
- There should be expertise in each organ transplant that has been clearly defined with the required experience in the respective department of specialization. A mention was made about the maintenance of minimum standards of the hospital as per the Clinical Establishment Act 2010.
- Registration of retrieval center also requires ICU facilities along with prescribed expertise and should be attached to the nearest government hospital designated for post-mortem, for retrieval in medico-legal cases.
Authorization Committee (Rules 11, 12, 13, 14, THOTA 2014)
A state-level committee for authorization should be constituted in each state. Hospital-based or institution-based authorization committees would be available if each hospital does more than 25 transplants in a year. In case transplantation is between near relatives, the for permission the State level committee is competent. If transplantation is between other than near relatives or foreigner donor/recipient, then the authority of permission is the authorization committee.
The function of State-level authorities is to verify the evidence of a relationship between donor and recipient with relevant certificates (Aadhar card, ration card, voter card, marriage certificate, PAN card, driving license, and birth certificate). If not convinced about the relationship, further tests like DNA tests may be done at NABL accredited labs.
In case of other than near relatives, the authorization committee needs to evaluate regarding proof of the link between donor and recipient, commercial transaction, reasons of donation, circumstances leading to donation, and old photographs of donor and recipient together. In the case of a married couple, the establishment of factum and duration of marriage need to be done. In the case of foreigners, Form 21 from the embassy of that particular country needs to be submitted, which is proof of the relation between the donor and recipient.
Form 7 is for pledging the organs before death. Form 8 is for a declaration by the near relative or either of the parents (in case of minors), and Form 10 is for brain death certification whereas Form 9 applies for consent in case of unclaimed bodies. Brain stem death certificate format for the first and second examination, supposed to be done 6 h apart, has been defined in THOTA 2014. Brain stem death certification would be made by RMP in charge of the hospital, RMP nominated by an appropriate authority, neurologist/neurosurgeon of the hospital (anesthetist/physician/surgeon in case neurologist/neurosurgeon is not available), and RMP in charge of the treatment.
Types Of Donors for Organ Transplant
Living donors
These may be living-related donors, spousal donors, or other than near-related donors for organ transplant. With relation to Near-related donors for organ transplant it includes parents, siblings, and children. In the recent 2014 rules, grandparents have also been included in the list of near-related donors. There should be documentary evidence of a relationship, for example, relevant birth certificates, relationship certificate from Tehsildar or subdivisional magistrate or Metropolitan Magistrate or similar other identity certificates such as Aadhaar card and documentary evidence of identity and residence of the proposed donor, ration card, or voters’ identity card or passport or driving license or permanent account number card or bank account and a family photograph depicting the proposed donor and the proposed recipient along with another near relative.
The forms required to be filled in live donation for organ transplant include Form 1 for donor consent, Form 4 for donor fitness, Form 11 which is a joint application form, and committee permission which is given as per the format given in Form 18.
Spousal donor
Spousal transplants in organ transplant are also considered near-related transplants. Where the proposed transplant is between a married couple, documents such as marriage certificate and marriage photograph are kept for records along with the information on the number and age of children and a family photograph depicting the entire family and birth certificate of children containing the particulars of parents. For a spousal donor, the forms required thus include Form 2, Form 4 for donor fitness and Form 11 which is a joint application form filled by donor and recipient. The committee grants permission in the format given in Form 6.
Swap donation
It is also included in the 2014 rules. Swap donation means, if in a family (family number 1), you have a donor and recipient who are near related but their blood group is incompatible, i.e., the donor is A+ and recipient is B+, and in another family (family number 2), the donor is B+. while the recipient is A+, the donor of family number 1 can donate to recipient 2, and donor 2 can donate to recipient 1. This can help to increase the donor pool. Swap transplant should be carried out simultaneously, so there is no donor reneging. Donor reneging means that one of the donors backs out from donation. Furthermore, the donor and recipient pair in a family should be near related.
Foreign donors
In the case of foreign donors in organ transplant, that are donating to their relatives in India, the transplantation is permitted only in near-related donors. Indian living donors wanting to donate to a foreigner other than a near relative shall not be considered. In case of foreigners coming for transplantation in India, for example, donor and recipient being foreigners, the transplant is permitted in India with permission from a senior embassy official of the country of origin who certifies the relationship between the donor and the recipient, and in case, a country does not have an embassy in India, and the certificate of relationship is issued by the government of that country. For all living donations, the donor is subjected to all such medical tests to determine his or her biological capacity and compatibility to donate the organ. The physical and mental evaluation of the donor should be certified by the registered medical practitioner in Form 4.
Amendments to the Provisions Of the Act
The main provisions of this Act Added recently are as mention below: –
Living Donations
For living donation, people who can donate without any legal formalities include mother, father, brothers, sisters, son, daughter, and spouse. Recently, in the new Gazette grandparents have been included in the list of first relatives. The first relatives are required to provide proof of their relationship by genetic testing and/or by legal documents. In the event of there being no first relatives, the recipient and donor are required to seek special permission from the government-appointed authorization committee and appear for an interview in front of the committee to prove that the motive of donation is purely out of altruism or affection for the recipient.
Regulation of organ transplant activities by forming an Authorization Committee (AC) and Appropriate Authority (AA) in each State or Union Territory.
The role of the Authorization Committee (AC) is to regulate the process of authorization to approve or reject transplants between the recipient and donors other than a first relative. The primary duty of the committee is to ensure that the donor is not being exploited for monetary consideration to donate their organ. Information about approval or rejection is sent by mail to the concerned hospitals. The decision to accept or reject a donor is governed by Sub Clause (3), Clause 9 of Chapter II of the THO act.
Role of Appropriate Authority (AA is to regulate the removal, storage, and transplantation of human organs. A hospital is permitted to perform such activities only after being licensed by the authority. The removal of eyes from a dead body of a donor is not governed by such an authority and can be done at other premises and does not require any licensing procedure. The powers of the AA include inspecting and granting registration to the hospitals for transplant surgery, enforcing the required standards for hospitals, conducting regular inspections of the hospitals to examine the quality of transplantation and follow-up medical care of donors and recipients, suspending or canceling the registrations or erring hospitals, and conducting investigations into complaints about breach of any provisions of the Act. The AA issues a license to a hospital for a period of 5 years at a time and can renew the license after that period. Each organ requires a separate license.
Penalties and Punishment
Punishment for removal of the human organs/organ transplant without authority.
Any person who renders his services to or at any hospital and who, for purposes of transplantation, conducts, associates with, or helps in any manner in, the removal of any human organ without authority, shall be punishable with imprisonment for a term which may extend to ten years and with fine which may extend to twenty lakh rupees.
Punishment for commercial dealings in human organs is when:
Whoever:-
(a) makes or receives any payment for the supply of, or for an offer to supply, any human organ;
(b) seeks to find a person willing to supply for payment any human organ;
(c) offers to supply any human organ for payment; or
(d) initiates or negotiates any arrangement involving the making of any payment for the supply of, or for an offer to supply, any human organ;
(e) takes part in the management or control of a body of persons, whether a society, firm or company, whose activities consist of or include the initiation or negotiation of any arrangement referred to in clause (d).
Conclusion
The matter of organ transplant is very sensitive and following the legal procedure as prescribed is essential. In order to avoid any complications, the law should be followed and the hospital, donors all should be complying with the rules provided. In case of any violations, the appropriate authority should be informed.
References
Sunil Shroff, Legal and ethical aspects of organ donation and transplantation, Indian J Urol. 2009 Jul-Sep; 25(3): 348–355.
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