Introduction
Recently on August 5, 2024, the Indian Government unveiled a comprehensive Standard Operating Procedure (“SOP”) that aims to streamline and enhance the transportation and transfer of human organs throughout the nation by various modes of transportation. The Union Ministry of Health and Family Welfare through this initiative seems to establish rigorous protocols for maintaining and securing organs at appropriate conditions. While the recent SOP aims to address the logistical challenges of organ transfer, there are various other lacunas in the present legislation i.e., the Transplantation of Human Organs and Tissues Act, 1994 (“Act”) which governs the transplantation of human organs in India.
The Act is applicable to the entire nation except the State of Andhra Pradesh. Despite the act being implemented, organ trafficking and kidney scandals continue to exist. Recently in July 2024, the Delhi Police busted the organ transplant racket with international links operating across India & the globe. While this act was a step forward in regulating organ donation and transplantation in India, it still had some shortcomings.
In this article, the authors discuss aspects of the Indian Organ Transplantation Law, the loopholes within the Act, and have proposed solutions, and an analysis of the new guidelines regulating the carriage of human organs. In the last section, the author presents some final reflections and guidelines for doing so.
Unravelling the Quandaries of Organ Donation Law in India: A Critical Analysis
The Maneka Gandhi v. Union of India case broadened the scope of Article 21 of the Constitution of India, expanding the right to life to include living with dignity. The Supreme Court's interpretation established the foundation for recognizing socio-economic rights, such as the right to health, as integral to the right to life. The Act helps to protect the ‘Right to Life’ enshrined under Article 21 by providing a means for patients in end-stage organ failure to access the lifesaving medical procedure of transplant surgery.
The Act aims to address numerous muddles regarding organ transplantation, inter alia, commercialization, or trafficking of organs and tissues. However, despite the Act criminalizing the same there is no significant development in the concerned arena. This can be substantiated by the ‘NHRC Report on Missing Child’ which states that an average of 44000 children are reported missing with 11000 remaining untraced, numerous suspected to be victims of to organ trafficking. The country is at the forefront of commercialization of organs and tissues. While the Act aimed to curb illegal practices and regulate organ transplantation, the challenges persist.
Section 5 of the Act is complicated because it grants the authority to the person in charge of a hospital or prison to remove organs from a deceased individual's body if the body remains unclaimed by a near relative within forty-eight hours. It means that it is the responsibility of the person in charge to make reasonable efforts to locate and inform the near relatives of the deceased. However, this can become an issue if the person in charge has a vested interest in the outcome. If they fail to inform the relatives within the specified time frame, either intentionally or negligently, they could proceed with the removal of organs without proper oversight. Wherein next of kin have not been informed in time or where efforts to locate them are deemed inconclusive there is virtually no legal redress available to the family to appeal the decision after organs have been harvested. It not only results in potential ethical issues but also affects the trust of the public in organ donation frameworks. This situation opens the door to potential misuse, undermining the purpose of the Act. To address these concerns and strengthen the integrity of the process, it is essential to combine robust oversight with technological advancements.
There should be obligatory reporting of all procedures to the managing authority involved in organ removal like Hospital, and to search for and notify the near relatives of the deceased person, for the purposes of increasing control and accountability. The management should ensure that proper documentation is done by the person in charge. These records should be audited by an Independent Committee (“IC”) to maintain the record’s transparency. Furthermore, those organs should not be harvested from an indefensible body until the IC affirms the failure of an exhaustive search to find the next of kin. However, this should be expedited else the body will start decomposing and preservation will be difficult. Such efforts may be enhanced by the use of technology such as automated systems that search both the national databases to find the relatives as a way of reducing chances of overlooking or neglecting them. Collectively these measures would afford a solid structure towards preventing such misuse and or safeguarding ethical practices.
Another limitation of the Act lies in Section 9, Section 9(1), which states that the person before his death cannot donate any organ to any outsider or stranger other than the person’s near relatives with an exception under Section 9(3) where an individual may donate before his death to someone who by the reason of affection, attachment, or other special reasons, but this requires prior approval from the Authorization Committee. The provision mentioned above is problematic because it lacks clear definitions for "affection," "attachment," and "special reasons," leading to subjective interpretations by Authorization Committees. This vagueness opens the door for potential misuse, where false emotional bonds or fabricated special reasons can be used to justify organ donations, enabling commercial exploitation, and undermining the Act's intent to prevent organ trade.
Middlemen and organ racketeers exploit legal provisions, targeting economically disadvantaged individuals by promising money or benefits in exchange for organ donations. They fabricate documents to falsely establish relationships or affection between donor and recipient. Furthermore, the broad interpretative scope of “special reasons” lets organ racketeers conjure up special reasons, which perverts the function of this law of stopping the selling of organ donors and defending the weak from being exploited.
To overcome this issue, we need to elaborate on what can be called “affection,” “attachment”, and “special reasons.” The Authorization Committees should be provided substantive recommendations how it is supposed to make rational decisions that claim “special reasons” in operation shall be subjected to scrutiny and the donors’ and the recipients’ shall be required to provide sufficient evidence to prevent abuse and unlawful activities.
Furthermore, the demand for organ transplants in authorized hospitals and healthcare centres far exceeds the supply, leading individuals in need to resort to illegal methods to obtain organs. This is due to lack of public awareness, lack of understanding, cultural stigma, and mistrust in the medical system about organ donation. There is a need to launch campaigns that will target the specific population, involve mass media outlets, and introduce the issue of organ donation in schools. For instance, the Vishakhapatnam government recently, on August 2024 organized an organ donation awareness program to address the issue of lack of supply of organs.
While the Act addresses legal and ethical concerns in organ transplantation, including oversight and preventing illegal activities, a significant loophole was the lack of regulations on organ transportation. The introduction of the SOP by the Union Government fills this gap, ensuring safe, efficient, and regulated organ transfer practices. However, this SOP is not foolproof and has flaws which will be expounded in the subsequent part.
Streamlining Organ Transport: Key Guidelines and Challenges in the SOP
The SOP provides a comprehensive framework for the transportation of human organs from the donor to the recipient either in the same place or in different places. It provides different guidelines for different modes of transport which shall be followed during the time of transportation. The human organs under this include organs procured from living donors as well as from deceased donors with prior permission from the deceased’s family.
The SOP provides comprehensive guidelines for the transport of organs across various modes of transport which aims to streamline and optimise the process of organ transportation in India. It contains different and specific rules for different modes of transport, for example, it requires the screening of organ containers and maintenance of the sterility of organ, this ensures the safety of the organs and prevents contamination, impacting the overall success rates of transplants. To minimize the delay and maximise the efficiency in transport, the SOP prioritizes the medical personnel in transport logistics, requirement of green channels devoid of physical barrier and priority seating and reservation would help in the achievement of desired aim. The SOP can help in combating illegal organ trade as it requires a specific NOTTO-ID for all the organs transplanted, also ensuring in the conduct of transplant in a legal and ethical manner. This SOP aims to provide the optimal means of organ transport within India to give hope to the patients waiting for the transplant, and its successful implementation could set a benchmark in the world.
The SOP although a positive development is surrounded with several challenges that may affect its functioning. The actual deployment of the provisions may be hampered as it is challenging to meet multiple state and central regulations due to the variations in the laws of different states. States might also have different levels of capability to comply with the SOP, and even more so when it comes to inter-jurisdictional cooperation as the cooperation efforts will differ due to involvement of multiple jurisdictions across states, the coordination between the state health departments, transport authorities will be difficult to achieve.
Effective Documentation and authorization are very important to ensure that the transport of a patients and organs is done according to procedure, minimizing the risk of a lawsuit or infringement of the patient’s rights. This means that to determine liability in cases of delays or mishandling there must be certain principles that define accountability that define responsibilities of stakeholders. Legal framework mandating privacy and data protection require robust safeguards to prevent leakage of sensitive information of patients.
International organ transport further complicates the scenario, requiring compliance with glibal conventions such as the Declaration of Istanbul. This highlights the need to put in place effective mechanisms for monitoring and enforcing compliance with these guidelines. To achieve this, educating and training all personnel involved in organ transport is paramount, though challenging to implement uniformly due to logistical and resource constraints.
Timely delivery of organs is critical, which necessitates the use of reliable technology and infrastructure to resolve delays. Public awareness and cooperation are equally essential, particularly in promoting the use of green corridors in urban centres. Sensitizing citizens to the importance of these initiatives can enhance community participation and reduce logistical hurdles.
Addressing these challenges requires a multi-faceted approach: developing a strong legal and regulatory environment, refining Standard Operating Procedures ("SOPs") based on field feedback, and fostering collaboration across all levels—government, medical institutions, and the public. Only through such concerted efforts can we ensure the efficient, ethical, and lawful transport of organs and patients.
Conclusion
Ultimately, organ transplantation is not only a medical intervention but rather an achievement of humanity and people’s desire to save lives. Thus, by working on the insufficient legal regulation and application of the SOPs in the field, as well as increasing individuals’ and professionals’ understanding of the expediency and potential of the organ donation system, India could establish legal provisions that would create an effective, open, and ethical organ donation system that would indeed unlock the constitutional promise of life and human dignity for all its citizens.
The newly introduced SOP for the transportation of human organs in India is a significant advancement, aimed at ensuring the safe, ethical, and efficient movement of organs. However, the existing legal framework, still faces numerous challenges, including issues of illegal organ trafficking, vague legislative language, and a need for clearer oversight mechanisms.
This article has been co-authored by Abhishek Nande and Rahul Agrawal, students at the Hidayatullah National Law University, Raipur. This blog is part of the RSRR's Rolling Blog Series.
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