Examining the Legal and Ethical Dimensions in Organ Donation and Transplantation

Introduction

Living organ donors contribute organs such as a kidney, a portion of the liver, a segment of the pancreas, or a part of the lung to aid ailing individuals for therapeutic purposes. In India, the legal framework for organ donation from both living and brain stem dead donors was established through the Transplantation of Human Organs Act (THOA) in 1994. The act underwent an amendment in 2011, allowing swap transplants among incompatible living donor-recipient pairs. The subsequent Gazette notification of Transplantation of Human Organs and Tissue (THOT) Rules in 2014 further regulated these procedures. Notably, live organ donation in India is predominantly limited to kidney or partial liver donations. It is worth mentioning that individuals, born with two kidneys, can sustain a healthy life after donating one kidney to someone in need. Additionally, donors can contribute a portion of their liver, which typically regenerates within three months.

A living donor must meet certain health criteria, excluding conditions such as HIV, hepatitis, acute infections, uncontrolled high blood pressure, diabetes, cancer, and psychiatric disorders. In India, living donors are required to contribute organs motivated by pure love, affiliation, and affection, with a minimum age requirement of 18. These transplants involve organs donated by both living and brain stem dead donors.

Kinds of Living Donors

Two types of living donors who can donate organs are:

1. Known Organ Donors- These organ donors are individuals with an established connection to the recipient, either through biological ties or longstanding social relationships. The donation is characterized by a bond of love and affection, with the donors choosing to share their organs to save the life of a loved one. However, the verification of such relationships requires the submission of various documents to the “Competent authority” or “Authorization Committee” to ensure the authenticity of the donor-recipient relationship. Near Related Organ Donor- Under THOT Rules 2014, the transplantation of organs is sanctioned among near relatives, including spouses, parents, siblings, children, grandparents, and grandchildren. However, this requires approval from the “Competent Authority,” which is typically the Director, Medical Superintendent, or in-charge of a hospital. The role of the “Competent Authority” is to verify the authenticity of the donor-recipient relationship, ensuring that it is genuine and free from any coercion or undue pressure on the donor. Other than Near Relatives- In India, organ donation by individuals beyond near relatives (friends, uncles, aunts, cousins, etc.) is allowed with the endorsement of an “Authorization Committee” at the hospital, district, or state level. Hospitals conducting more than 25 transplant surgeries annually can establish a “Hospital Authorization Committee.”
2. Unknown Organ Donors- These donors are unfamiliar to the recipients, and there is no emotional bond or connection between them. Purely Altruistic Organ Donors- Some individuals, motivated by appeals in print or electronic media, donate organs to strangers or contribute to anyone on the waiting list, sometimes initiating a domino chain of organ donation. While such altruistic or anonymous organ donations are permitted in advanced nations like the USA and the UK, Indian law currently does not allow for such living donors. Quasi – Altruistic Organ Donors- A quasi-altruistic donor is an individual who donates an organ after receiving the same organ from either a living or deceased donor. This scenario is common among heart or liver domino donors. For instance, a quasi-altruistic domino heart donor contributes their healthy heart to someone in need after receiving two lungs and a healthy heart from a deceased donor. Similarly, a quasi-altruistic domino liver donor donates their liver to another recipient after receiving a portion of the liver from either a living or deceased donor. This unique form of live donation, known as domino donation, allows the donor to simultaneously become a recipient and donor. Unlike regular live donors, there is no age restriction for domino donors. According to the THOA-1994, this form of live donation is permitted as it provides therapeutic benefits to both the donor and the recipient. Non-Altruistic Organ Donors- In this category, the donor remains anonymous to the recipient. Individuals donate organs to strangers with the condition that they receive the best-matched organ for their own relatives or friends, to whom they intend to donate organs. This reciprocal arrangement is known as a swap transplant. If organs are exchanged among more than two incompatible donor-recipient pairs, it is referred to as a domino transplant.

Challenges and Obstacles in Living Organ Donation

1. Issues with Authorization Committees

Delays in Scrutinizing Applications- Authorization committees are not meeting regularly to assess donor-recipient motives, causing approval delays and impacting desperate recipients. Inconsistent meetings are attributed to the committees’ composition, consisting of senior individuals with busy schedules. Some committee members may lack understanding of medical urgencies, leading to delays and wasted time, hindering life-saving efforts.

Abuse of Organ Donation Laws and an Overcautious Health System- Organ trade rackets are discovered yearly, making the health system cautious even in genuine cases. Misuse of technology, such as photo manipulation and fake documents, poses challenges for authorities. Instances of creating fake identities for paid living donors, known as “proxies,” complicate the evaluation process. Ethical dilemmas arise for committees, torn between strict legal adherence and making exceptions to save lives, leading to criticism regardless of their decisions.

Ethical Dilemmas and Overcautious Health System- Authorization committees sometimes struggle to discern the true motives of highly motivated living donors. Motives include gaining respect in a matrimonial house, fear of rejection by family or society, promises of foreign trips or jobs abroad, and employment in family businesses. Committees face ethical dilemmas in choosing between strict legal adherence and relaxing rules to save lives, risking criticism in either scenario. Overcautious health systems contribute to unnecessary transplant delays by referring near relatives to overburdened authorization committees instead of the less time-consuming ‘Competent Authority.’

2. Entire focus on Deceased Donation

Meeting the Growing Demand for Organ Transplants- India faces a substantial demand for organs due to the prevalence of diabetes and hypertension. Relying solely on deceased donation is insufficient; there is a need to emphasize living organ donation. Countries with high deceased donation rates, like Spain and the USA, also actively engage in living organ donation.

Persuading States to Adopt Transplantation Laws- Health being a state subject, most states have not adopted the Transplantation of Human Organs Act (THOA)-2011 legalizing swap transplants. THOA, 1994 has been adopted by all states except Jammu and Kashmir and Andhra Pradesh. Persuading states to adopt amended acts and rules, including the benefits of an extended list of donors and swap transplants, remains a significant challenge.

Registering More People for Swap and Domino Chains- Encouraging more donor-recipient pairs to register for swap transplants is crucial. The Apex Swap Transplant Registry addresses incompatibility among donors and recipients. Establishing Regional and State Organ and Tissue Transplant Organizations (ROTTO and SOTTO) and creating paired donation transplant registries nationwide under the National Organ and Tissue Transplant Organization (NOTTO) is a complex task requiring active participation from all states.

Preventing Exploitation and Ensuring Informed Decision Making- Living donors and their relatives often receive selective information about costs and risks, leading to exploitation. Instances of exorbitant charges, unethical practices, and inadequate information disclosure have been reported. The focus on financial transactions sometimes overshadows the importance of ensuring donors are well-informed and protected.

3. Infrastructure and Manpower Shortages

Government hospitals face a lack of both infrastructure and skilled personnel for transplant surgeries. Out of approximately 250 transplant centers in India, the majority are in private institutions. About 90% of transplant surgeries are conducted in private hospitals, resulting in long waiting lists in government hospitals. Some cases, such as a recipient funded by the Prime Minister’s Office for a kidney transplant, highlight the severe consequences of delays in the government sector.

4. Absence of Comprehensive Data on Risk

Living donors often make decisions impulsively due to moral obligations towards family, friends, or society. Social norms play a significant role in living donations, with donors not thoroughly considering the potential risks to their own health and life. There is a lack of a structured mechanism to follow up with donors, resulting in an absence of comprehensive data on post-donation outcomes. The absence of such data makes it challenging for donors to accurately assess the risks associated with their organ donations.

5. Neglect of Unforeseen Medical Issues in Living Donors

The lack of consideration for unforeseen medical issues in living donors is evident, raising concerns about prioritizing financial interests over donor health. The decision to donate involves significant risks and potential long-term financial implications. Without adequate insurance coverage, the well-being of donors, including recovery and productivity post-surgery, remains a neglected aspect that requires attention and resolution.

 The Future Path

1. Infrastructure Challenges and Data Compilation- Improving government infrastructure for surgeries is challenging, but the National Organ and Tissue Transplant Organization (NOTTO) aims to compile comprehensive data on living donors through Regional and State Organ and Tissue Transplant Organizations (ROTTO and SOTTO) with cooperation from states.
2. Donor Follow-Up Register and Informed Decision-Making- Establishing a Donor follow-up register at NOTTO, ROTTO, and SOTTO can provide comprehensive data for prospective donors to make informed decisions about potential risks.
3. Streamlining Approval Processes– To prevent delays, make it mandatory for “Authorization Committees” to scrutinize applications within two weeks.
4. Health Insurance for Living Donors- Emulate practices in Israel and Singapore by ensuring health insurance for living donors, emphasizing concern for their post-donation medical issues. Consider making it mandatory for recipient families to contribute toward risk coverage for donors, akin to risk coverage allowance for health professionals.
5. Regulating Transplant Surgery Costs- Address unregulated transplant surgery costs by following the model for Central Government Health Scheme (CGHS) beneficiaries.
6. Gender Sensitivity and Priority for Women- Sensitively address gender issues, giving priority to women in waiting lists for deceased donation due to societal dynamics.
7. Challenges of State Subject and THO Amendment Act- Overcome challenges arising from health being a state subject by encouraging all states to adopt the THO Amendment Act-2011, with ongoing efforts by NOTP and NOTTO officials.
8. Transparency and Patient Welfare- Combat patient exploitation by making it mandatory for transplant hospitals to disclose patient lists and total payments. Mandate hospitals to publish survival rates of transplant surgeries on their websites, fostering competition and informed choices by families.
9. Government Support for Lifelong Post-Transplant Costs- Consider providing lifelong coverage for post-transplant medical costs to ensure justice for less affluent individuals.

Conclusion

In conclusion, this examination provides insights into living organ donation practices in India under the Transplantation of Human Organs Act (THOA) 1994 and its amended version. The classification of donors, roles of authorities, and various challenges are discussed. The article underscores the need to address issues like infrastructure limitations, data gaps, gender bias, and technology misuse. Key challenges include motivating states to adopt amended acts, increasing registrations for swaps, preventing hospital exploitation, and enhancing the focus on living organ donation. The path forward involves collaborative efforts by the National Organ Transplant Programme (NOTP) and the National Organ and Tissue Transplant Organization (NOTTO) to navigate these challenges and improve ethical practices in living organ donation in India.

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Written by- Afshan Ahmad