Eye (cornea) donations have restored eyesight for millions of patients suffering from blindness. Similarly donation of vital organs such as heart, lungs, liver and kidneys has the potential to save many lives. Transplantation of these organs is not only life-saving but also improves quality of life of patients with end stage organ failure.
Over the last few decades, improvements in surgical techniques and transplant medicine have evolved. Complex operations such as kidney, liver and heart transplants are routinely performed all over the world with good success rates. Transplantation of lungs, pancreas and intestines are less common and performed at few specialized centers. The limits of transplantation are being redefined by success of complex transplants such as limbs and face, which were hitherto only science fiction. The science of transplantation has progressed fast in the last few decades. However, these advances have posed many legal and ethical questions.
Unfortunately, patients that are unable to undergo a transplant in time face a high risk of mortality. Transplants are typically done using organs donated after brain death of any person (also called as cadaveric donor). Unfortunately, worldwide there is a shortage of deceased (cadaveric) donors organs compared to number of patients with end stage organ failure in need of a transplant. This implies that all patients who need a transplant are unable to have it.
Prioritization Of Patients & Consent
The only way to try and maximize the benefit of transplantation is prioritization of patients on a waiting list using a transparent system that is fair to most patients. Prioritization may be done according to disease severity, chronological date of listing, loco-regional proximity or hospital based rotation system. Despite most western countries having focused on promoting and laying down systems for cadaveric organ donation from deceased, there is still a huge gap in organ demand and availability. Efforts to increase cadaveric donations by various countries take into account local societal beliefs and norms. In countries like the India, USA, UK, Germany, and Netherlands a ‘family consent’ is required for organ donations, where people sign up as donors, and their family’s consent is required. Other countries like Singapore, Belgium, and Spain have a more aggressive approach of ‘presumed consent’, which permits organ donation by default unless the donor has explicitly opposed it during his lifetime.
East vs. West
Cadaveric organ donation as a concept did not catch on well in most eastern countries. One of the solutions was to do living donor transplants i.e. organs such as liver, that can be split into two lobes, and kidneys, which are paired, can be donated by a healthy person and used for transplantation of a patient. Living donor transplantation made transplantation successful in most eastern countries. The risk to the donor, although small, is not in accordance with the Hippocratic Oath and ethical principles of practice of medicine i.e. “do no harm”. Living donor transplantation also carries the risk of organ trading and trafficking. ‘Transplant tourism’, incidences of patients from western countries travelling to underdeveloped countries for transplant surfaced. In India, with trained transplant personnel, lack of a national health insurance scheme, growing disparity between the rich and poor and weak social and legal institutions made commodification of organs a simple, quick and attractive business proposition for some and a solution for others.
However, basic human rights such as life, bodily integrity and liberty should not have a monetary price and should not be bought, sold, traded or stolen. Media reports of these malpractices in India have attracted worldwide criticism and have eroded the credibility of transplant community in the past.
The Transplantation of Human Organs Act (THOA), 1994
The government of India enacted The Transplantation of Human Organs Act (THOA) in 1994. Protocols and procedures for implementation of the act were outlined in THOA rules in 1995. This resulted in attempts at transplants in next few years and control of the organ trade.
Over the next decade, it was felt that the law had not made the desired impact on the growth of transplantation in India. In order to correct some problems with the original act and to keep up with further progress in transplantation, amendments to the act were proposed in 2009 and enacted in 2011.
In India, health being a state subject, while the central government can make health related laws, each state has to adopt it for it to be effective in that state. New THOA rules to implement the provisions of the 2011 amendments were notified vide the Gazette in 2014 and are being studied by most states for implementation.
Following are the highlights of the current transplant law (including amendments) in India:
• The Transplantation of Human Organ Act (THOA) regulates removal, storage and transplantation of organs and tissues in India. The act mandates that organ donation can be done for therapeutic purposes only.
• The law requires all transplant centres to update details of all transplant related activities such as number of cases, outcomes and costs periodically to the government and to public at large through a website.
The regulatory and advisory bodies for licensing, monitoring and penalizing transplantation related activities are the following:
• Appropriate Authority (AA): Inspects and grants registration to hospitals for transplantation; regulates and enforces standards for hospitals, conducts regular inspections to ensure quality of transplant care and outcomes of donors and recipient. It may conduct investigations into complaints of breach of any provisions of the Act, has the powers of a civil court to summon any person, request documents and issue search warrants and may suspend or cancel registration of erring hospitals, and conducting investigations into complaints for breach of any provisions of the Act. A separate license is granted for each organ of transplantation which is valid for 5 years at a time and may be renewed.
• Advisory Committee: The advisory committee’s role is to guide the government to appropriately implement the act and update the act and rules in accordance with medical progress in transplantation. The committee is chaired by the secretary to the state government and has a joint secretary representing ministry of health. Two experienced postgraduate medical experts (from different domains i.e. heart, liver, kidney, etc.), two eminent social workers, one from a women’s organization, one legal expert i.e.an additional district judge are members of the advisory committee.
• Authorization Committee (AC): Regulates living donor transplantation by reviewing each case of transplant and ensure with reasonable certainty that the living donor is not exploited for monetary considerations and prevent commercial dealings in transplantation. Their purpose is to regulate the process of authorization to approve or reject transplants between the recipient and donors other than ‘near relative’. The hospital based authorization committee consists of the medical director or medical superintendent of the hospital, two senior medical practitioners, not part of the transplant team, two members of high integrity, social standing, and credibility and secretary (Health) or nominee and Director Health Services or nominee. The state level authorization committee also consists of medical practitioner officiating as Chief Medical Officer or any other equivalent post in a main/major government hospital of the district.
• Medical board: Panel of doctors responsible for brain death certification. Generally consists of a neurologist, neurosurgeon, Intensivist, anesthetist or in their absence any surgeon or physician nominated by medical administrator in-charge of the hospital.
Infrastructure, facilities and manpower requirements and processes for institutions involved in transplantation:
• THOA defines the facilities, infrastructure, equipment and manpower requirements for any transplant centre and the process for grant of license for the same. Similarly, infrastructure, equipment, guidelines and standard operating procedures for tissue banks is outlined. Typically, a hospital would apply for transplant license for one or few organs only, depending on their area of interest and expertise available and would be given license for that particular organ transplant only. The format for application for transplant license by the hospitals and that for grant of the same is laid out in the rules.
• Mandatory expert manpower requirements in the transplant team (depending on the organ / tissue) and their qualifications are defined for the following:
o Transplant surgeons (depending on organ of interest)
o Cornea and tissue retrieval technicians (for eye banks)
o Transplant coordinators
• NTORCs (non-transplant organ retrieval centre) are ICU equipped hospitals where organ retrieval alone can be performed once registered with the appropriate authority.
• Non-governmental organisations (NGOs) are registered societies and trusts working to facilitate organ or tissue removal, storage or transplantation, require registration with the government.
The act recognizes two types of transplants and defines processes associated with each of them:
Deceased donor (Cadaveric) transplant:
• THOA recognizes brain death as a definite form of death and empowers specialists from the medical board to certify the same for the purpose of organ donation.
• In cases of brain death, the primary medical team is required to make the family aware about the option of organ donation and request for the same.
• The donor’s own authorization, if it was done before death in presence of two witnesses, is adequate, unless the next of kin has a reason to believe that it was subsequently revoked.
• Final authorization for organ donation after brain death may be given by the patient’s next of kin. In case of minors, authorization may be given by the parents. In case of unclaimed bodies, 48 hours after death, if it still remains unclaimed, person in-charge of the hospital or person in lawful possession of the body may give authorization for organ donation. The format for obtaining consent for organ donation is outlined in the rules.
• THOA outlines the procedure for certification of brain death and recognizes members from the medical board (medical practitioner incharge of the hospital, independent medical practitioner, a neurologist or neurosurgeon) or their alternatives, who are not members of the transplant team, are authorized to certify brain death. Brain death may be declared after two certifications by two experts each performed 6 hours apart. The format for certifying brain death is given in the rules.
• THOA rules state the qualification and experience of transplant coordinators, doctors or technicians who are authorized to facilitate the process and surgically retrieve the organs after duly personally verifying formal brain death certification. 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 cost of donor management, retrieval, transportation and preservation should not be borne by the donor or their families.
• In medico-legal cases, the process for facilitating organ donation without compromising the process for determining the cause of death i.e. autopsy is outlined.
Living Donor Transplantation
• Each living donor transplant case is permitted only after clearance by the authorization committee individually. The authorization committee reviews the documents and interviews the patient, donor and family to establish their relationship and rule out the possibility of organ trading with reasonable certainty.
• For living donor transplantation, grandchildren, children, siblings, spouse, parents and grandparents of the patient are termed as “near relatives” and these cases may be cleared by the hospital based authorization committee. Near relatives are required to provide proof of their relationship by legal documents or genetic testing.
• For living donors who are not “near relatives” and non-Indian nationals, approval from the state level authorization committee is required. Donors and patients are required to appear for an interview after submission of all documents supporting the claimed relationship between the two. The Authorization Committee also evaluates the possibility of commercial transaction between the recipient by studying and probing the circumstances and reasons why the donor wishes to donate, financial status of the donor with evidence of their vocation and income for the previous three financial years, any gross disparity between the status of the two and involvement of middleman or tout. The proceedings of the interview are video recorded.
• For living donors who are not local residents of the state where transplant is planned, a “No Objection Certificate (NOC)” may be required from their local state of residence in a prescribed format. Similarly for foreign nationals, a senior Embassy official of the country of origin has to certify the relationship between the donor and the recipient.
• Donation is allowed only after detailed explanation of possible effects, complications and hazards of the operation on the donor and recipient and its long term effects.
• Psychiatrist’s clearance in such cases is deemed mandatory to certify the donor’s mental condition, awareness, absence of any overt or latent psychiatric disease, and ability to give free consent.
• Donation by an Indian citizen for transplantation of a foreign citizen is prohibited except in exceptional circumstances.
• Living donation by a minor (< 18 years of age) or any other person mentally or psychologically unable to give consent for the same is prohibited.
• Swap transplantation is permitted for patients whose “near relatives” are unable to donate to their own patients because of medical reasons, but may be suitable for another patient. Two such patients can exchange their donors and both undergo a transplant.
• The Authorization Committee gives its decision in 24 hours in writing with the reason for rejecting or approving the application of the proposed donor. The decision of the Authorization Committee is displayed on the hospital notice board and website within 24 hours of the decision.
Stringent penalties for contravention of the law
Stringent penalties have been defined for removal of organ without authority, initiation or negotiation for making or receiving payment for supplying human organs, falsification of documents or contravening any other provisions of the act to serve as a deterrent for such activities. The penalty for any violation may be 5 to 10 years of imprisonment and / or 5 to 20 lakh rupees fine. A medical practitioner may be penalized by cancelling their license to practice in addition to the above.
National Human Organs and Tissues Removal and Storage Network
The act directs the central government to establish the National Human Organs and Tissues Removal and Storage Network at national and state levels. As part of this network, the government will maintain a website displaying current information about transplant activity in India and also maintain a registry of donors and recipients of transplantation to facilitate information exchange smoothly and transparently between patients, hospitals and government.
The success of transplantation as a life-saving treatment does not justify victimizing the world’s poor as the source of organs for the rich. Legal and ethical challenges emerging with the progress of transplantation may help resolve our conflicts related to cutting edge regenerative medicine such as stem cells transplants, cloning, and tissue re-engineering.