This article is written by Minal Mishra of 4th Year of BALLB of School of Legal Studies Reva University
Abstract
Organ donation and transplantation exhibit global disparities, mainly due to a lack of deceased donors. Efforts to boost donation rates have led to both effective strategies and ethically questionable practices. International bodies like the World Health Organization and The Transplantation Society aim to establish legal and ethical frameworks to eliminate unacceptable practices and promote self-sufficiency in organ transplantation. This involves reducing demand and maximizing deceased donation potential.
Living donors are essential in many regions, but their exploitation raises ethical concerns. Learning from countries with successful deceased donor programs is crucial to eradicating such abuses. India’s Transplantation of Human Organs Act of 1994 regulates organ removal and transplantation while preventing illicit trade. In the U.S., the National Organ Transplant Act established the Organ Procurement and Transplantation Network (OPTN) in 1984 to enhance organ matching, operated by the non-profit United Network for Organ Sharing under HRSA.
Keywords
Organ donation, donors, World Health Organization, organ transplantation, exploitation, India’s Transplantation of Human Organs Act, National Organ Transplant Act
Introduction
Organ transplantation stands as a critical and often sole remedy for patients grappling with end-stage organ failure. In the last decade, both governmental and professional sectors have shown substantial global interest in the realm of organ donation and transplantation. This surge in interest emerges from two primary factors. Firstly, the worldwide shortage of organs available for transplantation and the glaring international disparities in donation and transplantation practices. Secondly, there is an evident need to ensure that all advancements are rooted in legal and ethical principles, with an emphasis on equity, quality, and safety.
To provide a comprehensive overview of organ transplantation, it’s imperative to encompass both deceased and living donation. While deceased donation inadequately caters to the demand for transplantable organs across various countries, it remains nearly absent in some nations. This scarcity has led to the escalating use of living donors, particularly for kidneys and more recently for livers. However, this reliance on living donors has sparked contentious and ethically questionable practices. While efforts are directed toward curbing these practices, equal attention is dedicated to fostering “self-sufficiency” by instituting effective deceased donation programs.
The global response has resulted in the formulation of two sets of international agreements. The first, led by the World Health Organization (WHO) and endorsed by the World Health Assembly in 2010, encompasses revised Guiding Principles on Human Cell, Tissue, and Organ Transplantation. These principles pertain to both deceased and living donation and are accompanied by detailed commentary, encompassing 11 precise principles. They establish an ethical framework for the acquisition and transplantation of human cells, tissues, and organs while acknowledging that individual jurisdictions will determine implementation methods.
Additionally, a professional response has been coordinated by organizations like The Transplantation Society in collaboration with international professional societies. Notable initiatives include the Amsterdam Forum, the Vancouver meeting, and the Declaration of Istanbul on Organ Trafficking and Transplant Tourism. An example of a joint governmental and professional effort is the Resolution of Madrid, co-sponsored by the European Commission, WHO, Spanish Presidency of the EU, and The Transplantation Society. This resolution urges states to strive for self-sufficiency by enhancing organ donation efforts and addressing the burden of end-stage organ failure.
WHO Guiding Principles on Human Cell, Tissue & Organ Transplantation[1]
The WHO has issued 11 guidelines with respect to the organ donation:
1. Cells, tissues, and organs may be removed from the bodies of deceased persons for the purpose of transplantation if: any consent required by law is obtained, and there is no reason to believe that the deceased person objected to such removal.
2. Physicians determining that a potential donor has died should not be directly involved in cell, tissue, or organ removal from the donor or subsequent transplantation procedures; nor should they be responsible for the care of any intended recipient of such cells, tissues, and organs.
3. Donation from deceased persons should be developed to its maximum therapeutic potential, but adult living persons may donate organs as permitted by domestic regulations. In general, living donors should be genetically, legally, or emotionally related to their recipients. Live donations are acceptable when the donor’s informed and voluntary consent is obtained, when professional care of donors is ensured and follow-up is well organized, and when selection criteria for donors are scrupulously applied and monitored. Live donors should be informed of the probable risks, benefits, and consequences of donation in a complete and understandable fashion; they should be legally competent and capable of weighing the information; and they should be acting willingly, free of any undue influence or coercion.
4. No cells, tissues, or organs should be removed from the body of a living minor for the purpose of transplantation other than narrow exceptions allowed under national law. Specific measures should be in place to protect the minor and, wherever possible, the minor’s assent should be obtained before donation. What is applicable to minors also applies to any legally incompetent person.
5. Cells, tissues, and organs should only be donated freely, without any monetary payment or other reward of monetary value. Purchasing, or offering to purchase, cells, tissues, or organs for transplantation, or their sale by living persons or by the next of kin for deceased persons, should be banned. The prohibition on sale or purchase of cells, tissues, and organs does not preclude reimbursing reasonable and verifiable expenses incurred by the donor, including loss of income, or paying the costs of recovering, processing, preserving, and supplying human cells, tissues, or organs for transplantation.
6. Promotion of altruistic donation of human cells, tissues, or organs by means of advertisement or public appeal may be undertaken in accordance with domestic regulation. Advertising the need for or availability of cells, tissues, or organs, with a view to offering or seeking payment to individuals for their cells, tissues, or organs, or, to the next of kin, where the individual is deceased, should be prohibited. Brokering that involves payment to such individuals or to third parties should also be prohibited.
7. Physicians and other health professionals should not engage in transplantation procedures, and health insurers and other payers should not cover such procedures, if the cells, tissues, or organs concerned have been obtained through exploitation or coercion of, or payment to, the donor or the next of kin of a deceased donor.
8. All health-care facilities and professionals involved in cell, tissue, or organ procurement and transplantation procedures should be prohibited from receiving any payment that exceeds the justifiable fee for the services rendered.
9. The allocation of organs, cells, and tissues should be guided by clinical criteria and ethical norms, not financial or other considerations. Allocation rules, defined by appropriately constituted committees, should be equitable, externally justified, and transparent.
10. High-quality, safe, and efficacious procedures are essential for donors and recipients alike. The long-term outcomes of cell, tissue, and organ donation and transplantation should be assessed for the living donor and the recipient in order to document benefit and harm. The level of safety, efficacy, and quality of human cells, tissues, and organs for transplantation, as health products of an exceptional nature, must be maintained and optimized on an ongoing basis. This requires implementation of quality systems including traceability and vigilance, with adverse events and reactions reported, both nationally and for exported human products.
11. The organization and execution of donation and transplantation activities, and their clinical results, must be transparent and open to scrutiny, while ensuring that the personal anonymity and privacy of donors and recipients are always protected.
History of organ transplantation in India
Organ transplantation in India has a relatively shorter history compared to more developed countries. Kidney transplants started in the 1970s, initially limited to live donors in urban areas. The rise of kidney transplants led to a kidney trade, with paid donors attracting foreign patients. Amid this, a committee was formed in 1991 to report on organ transplantation, which laid the groundwork for the Transplantation of Human Organs Act in 1994. This Act defined brain death and criminalized organ commercialization.
Brain death signifies the cessation of brain functions, and while the heart might continue working due to life support, the person is declared dead. According to the Act, brain death involves the permanent cessation of brain-stem functions and requires confirmation by a medical expert board. Rules stipulate prerequisites for declaring brain stem death, involving dual examinations over a six-hour interval.
Laws and Regulations Governing Organ Transplantation in India
The principal legislation pertaining to the transplantation of organs in India is the Transplantation of Human Organs Act, enacted in 1994. The objective of this act is to regulate the removal, storage, and transplantation of human organs for therapeutic purposes, while also preventing illicit commercial activities involving human organs.
In India, matters concerning healthcare are administered by individual states. The genesis of the Act was based on the appeals of Maharashtra, Himachal Pradesh, and Goa, which subsequently adopted it by default. Subsequently, the Act was embraced by all states, except Andhra Pradesh and Jammu & Kashmir. Despite the existence of a regulatory framework, instances of illegal commercial dealings in human organs have been reported in the media. To address the shortcomings in the efficacy, relevance, and impact of the Act, an amendment was proposed in 2009 by the states of Goa, Himachal Pradesh, and West Bengal. The amendment, sanctioned by the parliament in 2011, was accompanied by rules enacted in 2014. These changes were adopted by the proposing states and union territories, and they can also be endorsed by other states through a resolution.
Key provisions of the Act, inclusive of the 2014 amendments and rules, encompass:
A. Recognition of Brain Death: Brain death is recognized as a form of death. Processes and criteria for certifying brain death are defined (Form 10).
B. Live and Cadaveric Organ Transplantation: The Act permits the transplantation of human organs and tissues from living donors and deceased individuals (following cardiac or brain death).
C. Regulatory and Advisory Bodies: The Act establishes regulatory and advisory bodies to oversee transplantation activities and defines their composition.
(i) Appropriate Authority (AA): The AA inspects and grants registration to hospitals for transplantation, enforces requisite standards, and conducts periodic assessments of transplantation quality. It also has the authority to investigate complaints regarding Act violations.
(ii) Advisory Committee: This committee, comprising experts, offers guidance to the appropriate authority.
(iii) Authorization Committee (AC): The AC oversees living donor transplantation, ensuring donors aren’t exploited for monetary gain. Proceedings are recorded, and decisions are communicated within 24 hours. Appeals against AC decisions can be made to state or central governments.
(iv) Medical Board (Brain Death Committee): A panel of doctors certifies brain death. In case of the unavailability of a neurologist or neurosurgeon, other medical professionals nominated by the hospital’s medical administrator may certify brain death.
D. Classification of Living Donors: Living donors are categorized as near relatives or non-related donors.
(i) Near-Relative Donor: Requires permission from the transplant center’s doctor-in-charge.
(ii) Non-Related Donor: Requires permission from a state-established Authorization Committee.
E. Swap Transplantation: Incompatibility between a near-relative living donor and the recipient permits a swap transplant with another unmatched pair.
F. Authorization for Organ Donation after Brain Death:
(i) Donors may provide authorization before death or
(ii) A person in legal possession of the body may provide authorization. Patients or their relatives are informed of the option if prior authorization isn’t available.
(iii) The process for authorization from unclaimed bodies is outlined.
G. Organ Retrieval: Hospitals with ICU facilities and registration with the appropriate authority can perform organ retrieval.
H. Cost Responsibility: Costs related to donor management, retrieval, transportation, and preservation are borne by recipients, institutions, governments, NGOs, or societies, not by donor families.
I. Medico-Legal Cases: Procedures for organ donation in medico-legal cases are defined to prevent hindrance to determining the cause of death and organ retrieval delays.
J. Transplant Center Requirements: Specifications for registering a hospital as a transplant center are outlined.
K. Tissue Bank Standards: Guidelines and procedures for tissue banks are detailed.
L. Qualifications: Qualifications for transplant surgeons, cornea, and tissue retrieval technicians are defined.
M. Transplant Coordinators: Mandatory appointment of transplant coordinators with defined qualifications in all transplant centers.
N. Registration of Organizations: NGOs, registered societies, and trusts engaged in organ or tissue-related activities need registration.
O. National and Regional Networks: The central government establishes a National Organ & Tissue Transplant Organization (NOTTO), Regional Organ & Tissue Transplant Organizations (ROTTO), and State Organ & Tissue Transplant Organizations (SOTTO).
P. Registry Maintenance: The central government maintains a registry of organ and tissue donors and recipients.
Q. Penalties: Stringent penalties are established for unauthorized organ removal, payment for organ supply, and other Act violations.
The Act’s rules encompass various forms, including those for consent, brain death certification, authorization, and registration.
The Transplantation of Human Organs Act plays a pivotal role in regulating organ transplantation in India, encompassing various provisions to ensure ethical practices and prevent organ commercialization.
Punishments as outlined in the Legislation
Section 18 of the aforementioned Act prescribes penalties for individuals involved in the lawful removal of human organs or tissues without proper authorization. Such individuals may face imprisonment of up to 10 years and a fine of up to Rs. 20 lakhs. In the event that the offender is a medical professional, the Appropriate Authority (AA) is mandated to report the matter to the State Medical Council. The Council has the authority to take punitive measures, including a temporary removal of the offender’s name from the council’s register for a period of three years for a first-time offense. Subsequent offenses could lead to permanent removal.
Under Section 19, individuals engaged in the commercial trade of human organs face more severe consequences. Offenders may be subject to imprisonment for a term ranging from 5 to 10 years, in addition to a fine ranging from Rs. 20 lakhs to Rs. 1 crore.
Similarly, Section 20 provides for penalties for violations of other provisions of the Act. Those found guilty could be subject to imprisonment for up to 5 years or a fine of up to Rs. 20 lakhs.
Current Situation in India
The diagnosis of brain death necessitates specialized Intensive Care Units (ICUs) equipped to support the patient’s remaining organ functions. However, the availability of such ICUs is limited, predominantly located in major cities, and often suffer from inadequate staffing and operational inefficiencies. Consequently, a precarious situation arises where the urgency of patients in critical condition competes with the imperative to effectively retrieve organs from brain-dead donors.
Obtaining informed consent from relatives of potential donors can be a challenging endeavor. The attending physician might not always be sufficiently motivated to seek consent from relatives, or circumstances might arise where patients lack relatives or their presence during the brain death diagnosis. Despite the Act granting the medical practitioner the right to remove organs for donation if the body remains unclaimed by relatives within 48 hours of death, issues can arise if relatives subsequently object to the procedure after the time period has elapsed.
Furthermore, organ transplantation is a multifaceted and expensive process that currently lacks state funding. Deceased donation predominantly takes place within the private healthcare sector, contributing to a disparity in accessibility. The majority of donors and recipients originate from private hospitals, leaving the option less accessible to economically disadvantaged segments of society, thus exacerbating the existing inequality.
Laws related to organ donation in USA
The National Organ Transplant Act (NOTA) of 1984[2] introduced the establishment of the Organ Procurement and Transplantation Network (OPTN)[3] within the private sector. Managed by the United Network for Organ Sharing (UNOS)[4] since 1986, acting through 11 regions, the OPTN oversees the entire process of deceased donor organ donation and transplantation.
This process involves various stages, starting from identifying potential organ donors, through to the actual transplantation. To ensure an optimal supply and quality of deceased donor organs, each step in this sequence needs to be optimized. The swift identification of potential organ donors, whether in the emergency department or the intensive care unit, is crucial. The majority of deceased organ donors in the US, about 90%, are individuals declared brain dead (DBD donors), while the remaining 10% are declared dead due to the cessation of cardiopulmonary function (DCD donors). Hospitals are legally required by the Center for Medicare and Medicaid Services (CMS) to refer all potential donors to the local organ procurement organization (OPO). The term “imminent death” serves as a performance metric, indicating patients who should be referred to the OPO. To identify these patients, hospitals often collaborate with OPOs, developing explicit clinical criteria for referral. One common approach is considering ventilator-dependent patients with a Glasgow Coma Scale score of 5 or less, who are expected to pass away in the hospital, as potential donors.
The concept of acquiring, receiving, or transferring human organs for valuable consideration for transplantation is prohibited by NOTA, provided the transfer impacts interstate commerce. However, this does not apply to human organ paired donation. Violation of this prohibition can lead to fines of up to $50,000 or imprisonment of up to five years, or both.
The US employs an “opt-in” organ donation system, where individuals during their lifetime or their next of kin after their death must explicitly consent to organ donation. In contrast, several European and South American nations utilize an “opt-out” system, where donation is presumed unless explicitly objected to.[5] The Uniform Anatomical Gift Act (UAGA) was established in 1968 to promote uniformity among state laws governing anatomical gifts. It allowed adults of sound mind to donate body parts at death, with next of kin being authorized in the absence of prior authorization or objection. Amendments to the UAGA were made in 1987 and 2006 to enhance organ supply, align with federal laws like NOTA, and clarify donor authorization.
The 1987 UAGA aimed to increase organ supply, comply with NOTA, and enhance donor authorization clarity. It removed the requirement for two witnesses to sign the donation document and emphasized that an individual’s choice to donate organs cannot be revoked by others. In 2006, the UAGA further refined provisions, focusing on ensuring that individuals’ documented wishes regarding donation are respected, preventing family members from overriding these decisions. As of 2017, 46 states, along with the District of Columbia and the US Virgin Islands, had adopted the 2006 UAGA, although some states had modified or added amendments.
NOTA, enacted in 1984, aimed to establish an equitable allocation system for organs from deceased donors and increase the available organs for transplantation. It defined organs, prohibited the sale of human organs for transplantation, and established the OPTN to coordinate the organ transplantation process. The OPTN, operated by UNOS, manages the organ waitlist, allocation, policies, and standards. The process involves transplant coordinators entering candidate information into the UNetSM database, which matches donors’ organs with suitable candidates, prioritizing medical urgency. The Scientific Registry of Transplant Recipients (SRTR) was established in 1987 to collect and evaluate data related to transplantation, helping inform evidence-based policies and support research.
The National Organ Transplant Act of 1984 established the Organ Procurement and Transplantation Network, with subsequent regulations like the Uniform Anatomical Gift Act guiding deceased organ donation and transplantation processes in the United States. The goal has been to ensure an equitable and organized system that optimizes organ supply and allocation for transplantation.
Conclusion
In conclusion, the legislation surrounding organ transplantation in India is characterized by a comprehensive framework aimed at regulating the removal, storage, and transplantation of human organs and tissues. The Transplantation of Human Organs Act, passed in 1994 and subsequent amendments, stands as a pivotal piece of legislation that addresses brain death identification, living and deceased organ donation, regulatory bodies, and penalties for violations. However, the current scenario in India reveals certain challenges. Limited access to specialized Intensive Care Units for brain death diagnosis and the intricate process of obtaining informed consent from relatives pose difficulties in effective organ retrieval. Furthermore, the private sector’s dominance in organ transplantation highlights issues of accessibility, particularly for disadvantaged communities. While the legislation serves as a crucial foundation, addressing challenges such as healthcare infrastructure, consent procedures, and equitable access to transplantation remains imperative. Ensuring effective implementation of the law, augmenting healthcare facilities, and promoting public awareness can collectively enhance the ethical, legal, and medical aspects of organ transplantation in India.
Global organ donation disparities persist due to scarce deceased donors. International efforts aim to create ethical frameworks, reduce exploitation of living donors, and achieve self-sufficiency. India’s 1994 Transplantation of Human Organs Act regulates organ procedures, while the U.S.’s National Organ Transplant Act established the Organ Procurement and Transplantation Network for improved organ matching.
References
2. https://www.who.int/health-topics/transplantation/
3.https://www.who.int/transplantation/Guiding_PrinciplesTransplantation_WHA63.22en.pdf/
[1] WHO GUIDING PRINCIPLES ON HUMAN CELL, TISSUE AND ORGAN TRANSPLANTATION as endorsed by the sixty-third World Health Assembly in May 2010, in Resolution WHA63.22
[2] National Organ Transplant Act, Public Law 98-507 (1984).
[3] Organ Procurement and Transplantation Network (OPTN) official website (optn.transplant.hrsa.gov).
[4] Uniform Anatomical Gift Act (1968, 1987, 2006), Uniform Law Commission.
[5] Shepherd, L., O’Carroll, R., & Ferguson, E. (2014)
