ABSTRACT
Organ transplantation involves removing an organ or tissue from a donor and transplanting it into a recipient whose organ has failed due to injury or illness. Despite the potential to save lives, there is a shortage of organ donors. This article reviews the global evolution of organ donation criteria, explores the legal frameworks of organ donation in India, and discusses the organ transplant process and waitlist, donor types, and obstacles to organ donation. It also examines the topic of organ trafficking and provides suggestions for improving the legal scenarios to ensure safe and ethical transplantation.
Keywords – Organ, Transplantation, Donation, Trafficking, Ethical, Legal frameworks
INTRODUCTION
Organ transplantation is a remarkable medical achievement that involves the removal of an organ or tissue from a donor and its transplantation into a recipient. The procedure is required when a recipient’s organ is damaged or has failed due to injury or illness. The act of extracting an organ or tissue from a donor and transplanting it into a recipient is called organ donation. Despite its potential to save lives, there is a significant shortage of organ donors compared to the demand for transplants. Worldwide, legal regulations heavily govern the process of organ donation, which is increasingly common in modern medicine.
Legal frameworks worldwide play a crucial role in regulating organ donation, with different countries adopting varying approaches. Some nations presume organ donation unless individuals opt out, while others require individuals to opt-in. Additionally, financial compensation for organ donation is allowed in some countries but prohibited in others.
RESEARCH METHODOLOGY
This legal article on organ donation laws in India and abroad uses a descriptive research methodology and secondary sources of information to analyze the current state of organ donation laws and policies. The research involves a comprehensive review of reliable and up-to-date scholarly articles, books, government reports, newspapers, journals, and websites. The research design is systematic and structured to ensure rigor and validity.
REVIEW OF LITERATURE
Organ donation is crucial in modern medicine as it has the potential to save many lives. However, despite its benefits, the demand for organs is far greater than the number of available organs. Dr. Mehmet Oz has noted that “The need for organs is far greater than the number available for transplantation. One donor can save up to eight lives.”[1] Due to this disparity, illegal trafficking and trading of organs have become prevalent, resulting in the need for laws and regulations to curb these activities. The Transplantation of Human Organs Act has been successful in this regard, and Justice B.N. Srikrishna, former Judge of the Supreme Court of India, emphasizes its effectiveness in creating an ethical and transparent system for organ donation and transplantation in India. Justice Dalveer Bhandari, former Judge of the Supreme Court of India, also highlights the effectiveness of the law in preventing illegal organ trade. The implementation of such laws ensures that organ donation is conducted ethically, transparently, and in the best interest of patients in need of organs.Despite the effectiveness of laws and regulations, there remains a significant lack of awareness regarding organ donation. As Dr. Christiaan Barnard notes, “We have to educate people to think about organ donation like they think about blood donation. It’s not that difficult.” Raising awareness about organ donation can help increase the number of organ donations and reduce the need for illegal organ trade.
HISTORICAL TIMELINE
Ancient Times: Organ donation is deeply rooted in Indian culture, with references dating back to ancient Indian texts such as the Vedas, Upanishads, and Puranas. These texts describe organ donation as a noble act that can bring spiritual upliftment to the donor, and in Hindu mythology, it is considered a sacred act that can bring about good karma for the donor.
The ancient Indian text, Sushruta Samhita, dating back to 600 BCE, describes successful kidney transplantation procedures with a success rate of up to 60%. The donor should be healthy and willing, and the surgery should be performed by a skilled surgeon. The promotion of organ donation is also evident in Hindu texts, such as The Manusmruti, which emphasizes the importance of donating one’s body. Chapter 2:22 of the Bhagavad Gita compares the process of shedding old clothes and putting on new ones to the eternal soul shedding its old body at death and reincarnating into a new one. Sushrut is considered the greatest surgeon of the pre-medieval period.
Modern Times: The first recorded instance of organ donation in modern times dates back to 1954 when Ronald Lee Herrick donated his kidney to his identical twin brother. Dr. Joseph Murray performed the surgery, for which he was awarded the Nobel Prize in Physiology or Medicine in 1990 for his contributions to organ transplantation. In 2015, a newborn baby became the youngest organ donor ever when he donated his kidneys to an adult with renal failure. Unfortunately, the baby only lived for 100 minutes after being born.
On the other end of the age spectrum, the oldest recorded cornea donor was a 107-year-old woman in Scotland who donated after her death in 2016. The oldest recorded internal organ donor was a 95-year-old man from West Virginia who donated his liver after passing away. [2]
GLOBAL EVOLUTION OF ORGAN DONATION CRITERIA
In 1968, a momentous proposal was put forth by a committee at Harvard Medical School, suggesting that the criteria for determining death should be based on brain activity. This proposal laid the foundation for a comprehensive code published in 1976 by the Royal College of the United Kingdom, which set out guidelines for determining “Brain Death”. Following suit, many countries, including India in 1994, have redefined death as the cessation of brain stem activity, thereby permitting the removal of organs after brain death has been declared.
To gain a better understanding of organ donation policies in other nations, a team of experts led by R.K. Srivastava, the Director General of Health Services, embarked on a mission to visit major countries and observe their protocols. Their findings revealed that most countries have implemented the presumed consent method, whereby individuals who are brain dead are presumed to have agreed to donate their organs. Alternatively, in certain situations, the donor’s family holds the right to provide consent.
WHAT IS BRAIN DEATH?
Brain death is a state in which all brain functions have irreversibly ceased, despite the heart still working due to artificial ventilation. Despite this, the patient can be legally declared dead.
In accordance with the definition outlined in the Transplantation of Human Organs Act (THOA), brain death is considered to have occurred when all brain stem functions have permanently ceased, as determined by a board of medical experts. The THOA Rules mandate specific preconditions that must be met by medical practitioners prior to pronouncing a patient as having brain stem death. Furthermore, the medical expert board must examine the patient’s body twice, with a six-hour interval between each examination, before making the declaration.[3]
LEGAL FRAMEWORK OF ORGAN DONATION IN INDIA
The regulation of organ donation and transplantation falls under the jurisdiction of The Transplantation of Human Organs Act, 1994 (THOA),[4] which aims to oversee the proper removal, storage, and transplantation of organs for therapeutic purposes while prohibiting transplant commercialism.
Initially proposed by Maharashtra, Goa, and Himachal Pradesh, THOA was later adopted by all states except Andhra Pradesh and Jammu and Kashmir. Despite this, the act failed to curb the human trafficking and commercialization of organs. As a result, the act was amended in 2009 to address its shortcomings. In 2011, the amendment was passed by the Indian Parliament, and subsequent rules were outlined in 2014.
Some critical provisions of the 1994 legislation include:
- The bill mandates the formation of an authorization committee consisting of a specialized group of experts at both the State and Centre levels.
- The authorization committee is responsible for maintaining data on available organs and granting permissions for organ transplants.
- Only registered medical professionals authorized by the committee are permitted to remove organs from a deceased person’s body for transplantation purposes.
- Hospitals, where transplants are performed, must obtain approval from State authorities to be designated as approved transplant centers.
- A person cannot be declared brain dead without the approval of a qualified neurosurgeon prior to commencing a transplant surgery.
- If no family members object, the deceased person’s relative may provide consent on their behalf.
FURTHER AMENDMENTS
In 2014, amendments were implemented to simplify and ease the organ donation process in order to increase the number of donors and prevent illegal transplants and human trafficking. Hospitals were granted permission to retrieve organs, and the presence of a neurosurgeon at the time of death was no longer mandatory. Physicians were responsible for educating families about the transplant system and encouraging them to proceed with the process. Finally, the expenses related to organ retrieval were to be borne by the recipient, their family, or the government or non-government organizations.
ORGAN TRANSPLANT PROCESS & WAITLIST
Organ transplantation begins when an individual’s organ fails, and require a transplant to survive. After being assessed by a transplant center, they may be added to the National Transplant Waiting List if they meet the necessary criteria. The waiting period for an organ then begins, and the system matches individuals with potential donors based on factors such as blood type, body size, the severity of the condition, distance from the donor, tissue type, and waiting duration. Organs are never matched based on gender, caste, income, or social status. However, delays in receiving organs due to the long waiting list cause a daily average mortality rate of 20% for those on the list.
In the context of organ donation, a living donor refers to an individual who has given explicit consent to the removal of an organ or tissue from their body during their lifetime. To be considered a living donor, the person must be at least 18 years old and legally capable of consenting to the donation.
KINDS OF DONORS
The Transplantation of Human Organs Act classifies donors into three types;
LIVING DONORS
It is legally permissible for a living donor to donate the following organs or tissues:
- One kidney, as the human body can function adequately with just one kidney.
- A portion of the pancreas, as half of the pancreas is sufficient to perform the organ’s necessary functions.
- A part of their liver, as the remaining segment of the liver can regenerate over time for both the donor and the recipient.
Living donors are further classified into three types:
- Living Near Related Donors: This category includes immediate blood relations such as parents, children, and siblings. Grandparents, grandchildren, and spouses who can prove their relationship are also accepted as donors.
- Living Non-near Donors: Donors who are not related to the recipient but are willing to donate out of affection and attachment towards them. Permission is required from the Authorization Committee, which is granted after an interview.
- SWAP Donors: This category allows for swapping donors when a near-relative donor is incompatible with the recipient. The donor of the first pair is matched with the second recipient, and the donor of the second pair is matched with the first recipient. However, it is only allowed for near-relative donors.
DECEASED/CADAVER DONORS
- Organs can be donated after brain or cardiac death, and individuals over 18 can give consent during their lifetime. When a patient is declared brain dead, medical practitioners must ask relatives about organ donation plans, even if the patient had given consent during their lifetime.
- The cost of maintaining the body, retrieving and preserving the organs or tissues, and transportation will not be the responsibility of the donor’s family. Instead, the recipient or institution will bear the cost as determined by the respective state government.
- Individuals can also indicate their consent for organ donation while applying for a driving license, which will reflect their preference.[5]
ORGAN DONATION IN THE US: UNOS & OPTN
UNOS is a United States-based organization responsible for managing the National Organ Procurement and Transplantation Network (OPTN). Through the UNOS Organ Center, organ donors are matched with waiting recipients 24/7, 365 days a year. When an organ becomes available, the local organ procurement organization sends medical, social, and genetic information to UNOS. UNOS then generates a list of potential recipients based on various factors such as blood type, tissue type, organ size, medical urgency, waiting time, and geographic proximity. This allocation process is carried out in a formal and rigorous manner to ensure that organs are allocated in a fair and efficient manner to those most in need within the United States.
Organ Procurement Organizations (OPOs) are non-profit entities in charge of retrieving organs from deceased donors for transplantation in the United States. By law, there are 56 OPOs, each assigned a designated service area, where they are exclusively authorized to procure organs. Although they may operate as monopolies, OPOs are also responsible for all donor hospitals in their designated service areas, regardless of the number of donors they receive.
OPOs are crucial in organ procurement. They work with families to obtain consent for donation and record donor data on UNetSM. UNetSM facilitates matching with potential recipients and OPOs facilitate authorization, testing, and recovery of donor organs. This process is vital to the legal framework governing organ donation in the US.
TRANSPLANT HOSPITALS
Transplant hospitals in the US operate independently and compete in a more entrepreneurial environment than OPOs. With over 250 such hospitals across the country, physicians refer potential end-stage organ failure patients to these facilities, which evaluate the patient’s diagnostic medical tests, mental health, and social support system before considering their addition to UNOS’ national waiting list.
If a transplant hospital accepts a patient as a transplant candidate, it records the individual’s medical information, including blood type and medical urgency, into UNetSM. This secure transplant platform links all OPOs and transplant hospitals, enabling the matching process with potential donors. This process is a critical component of the legal framework governing organ transplantation in the US.[6]
TRANSPLANTATION SYSTEMS
When it comes to transplant systems, there are two policies for deceased organ donation:
Opt-out policy (presumed consent):
- Assumes all individuals residing in a country/state to be willing deceased organ donors unless they explicitly state their preference against it while alive
- Preference against organ donation is often recorded in a national opt-out register
Opt-in policy (express consent):
- Requires individuals to explicitly express their willingness to be a deceased organ donor
- No one is presumed to be a donor unless they make such a statement.
Organ donation is governed by three primary legal frameworks worldwide. The “opting-in” system is followed by the UK, Germany, Italy, Canada, Australia, and New Zealand. In these countries, the individual in lawful possession of the body can authorize the removal of organs and tissues, with the next-of-kin usually asked for consent. In contrast, countries such as Austria, Belgium, and Singapore have implemented “opt-out” or “presumed consent” systems, presuming that individuals have given their permission for organ donation unless they specify otherwise before death. In the US, state law mandates that hospitals must make a “required request” to the next-of-kin of a prospective donor, and failure to comply can lead to denial of support from healthcare funding agencies. In India, the opt-in system is adopted, which emphasizes “encouraged voluntarism,” with individuals or their families indicating their willingness to donate organs as an act of altruism.[7]
CURRENT LEGAL SCENARIOS
Informed consent for organ donation from relatives can be challenging to obtain, particularly if patients have no relatives or their relatives are absent when brain death is diagnosed. The Transplantation of Human Organs Act allows doctors to remove organs for donation if the body is unclaimed by relatives within 48 hours after death. However, if relatives object to organ donation later, it can create problems. Diagnosing brain death requires specialized ICU facilities, which are limited and often located in large cities, leading to a challenging situation for medical professionals who must prioritize both a dying patient and a deceased patient requiring organ retrieval. This can result in brain-dead patients receiving lower priority.
Organ transplantation is a costly and complex process without state funding. A significant portion of organ donations in the private sector creates unequal access to transplantation, with wealthy individuals receiving most organs while the poor do not have the same option
OBSTACLES TO ORGAN DONATION IN INDIA
There are several reasons why the laws regarding organ transplantation are not being implemented properly;
The scarcity of suitable organ donors is a major issue, which is compounded by the lack of awareness among the general population. Moreover, there are issues with the efficient management of data related to organ donation, which exacerbates the problem. The Transplantation of Human Organs Act mandates the formation of authorization committees by each state to monitor the implementation of the laws. However, several states do not have such committees, leading to inadequate data management and a lack of public awareness. States like Tamil Nadu and Kerala have particularly poor data collection practices, which poses a significant challenge to the successful implementation of organ transplantation laws. Addressing these issues and ensuring effective implementation of the laws is crucial to improving the lives of those in need of organ donations.
The Joint Director of the Regional Organ and Tissue Transplant Organisation (ROTTO) has pointed out that physicians are largely negligent in approaching the families of patients following their demise in order to obtain consent for organ transplantation, and that no record of reluctance expressed by the deceased’s relatives is maintained by these physicians. This contributes to the problem of organ trafficking, which is exacerbated by the inadequate implementation of relevant laws and guidelines by hospitals and healthcare facilities.[8]
ORGAN TRAFFICKING
Organ trafficking is a serious issue that is often overlooked despite its lifelong health consequences for donors and recipients. Financial gain is prioritized over risks, leading to 10% of organ transplants involving trafficked organs, with kidneys being the most commonly trafficked. Though trading organs is illegal in most countries, few laws prohibit individuals from acquiring organs abroad. The illicit organ trade generates $840 million to $1.7 billion, and Dr. Amit Kumar’s case exemplifies the transgressions related to organ trafficking.
In India, it has been observed that a child goes missing every 8 minutes, with approximately 50,000 cases reported, and the number of missing children forced into illegal operations is unknown.
RED FLAGS FOR TRANSACTIONS
Although it may be difficult for banks to identify financial transactions related to organ trafficking, it is not an impossible task. Certain indicators, when combined, could signal suspicious behavior. These red flags include large cash withdrawals or transfers, payments between medical tourism sites and charities, individuals with illnesses transferring funds to multiple charities and companies, and websites offering transplant services overseas. By being vigilant of such indicators, financial institutions can potentially detect and prevent unlawful financial activity associated with organ trafficking[9].
SUGGESTIONS
Organ trafficking remains a serious issue in India, particularly through high-end hospitals that offer transplant tourism services. Although there are legal frameworks in place, the existing loopholes have failed to prevent illegal organ trade. To address this issue, an all-India law is needed, and the consent of the deceased should be given more weightage than that of family members. It is crucial to implement this law effectively and encourage more people to become organ donors. This requires the involvement of various stakeholders, including healthcare professionals, educational institutions, religious leaders, and the media. The government must also strengthen Anti-Human Trafficking Units to combat the transnational issue of organ trafficking, and transparency in medical activities is necessary for curbing corruption. Evaluating the effectiveness of current legal frameworks for organ donation and recommending future changes to organ donation laws and regulations are critical steps toward ensuring ethical and effective organ donation practices in India.
CONCLUSION
Over the last few years, India has made significant progress in its organ donation laws. The Transplantation of Human Organs and Tissues Act was passed in 1994, and in 2014, the National Organ and Tissue Transplant Organization (NOTTO) was established to regulate and promote organ donation. Collaborative efforts among the government, civil society organizations, and medical professionals are necessary to tackle the challenges in this area. Raising awareness, enhancing healthcare access, and ensuring ethical organ donation practices are essential steps to overcome these challenges. With the potential to save countless lives, improving and enforcing organ donation laws will contribute to a better quality of life for many in India.
- Sohini Chakraborty, 1st year Rgnul Patiala
[1] UNOS, https://unos.org/about/national-organ-transplant-system/ , (last visited Apr. 12, 2023)
[2] World Organ Donation Day: A brief history, HINDUSTAN TIMES (Apr. 12, 2023, 10:11 PM), https://www.hindustantimes.com/india-news/world-organ-donation-day-a-brief-history-101628815156959.html
[3] Suchita Kosare & Apeksha Gala, Brain Death and Organ Donation, JOURNAL OF RESEARCH AND INNOVATION IN ANESTHESIA, Res Inno in Anesth 4(2):45–49 (2019).
[4] Transplantation of Human Organs Act, 1994, No.42, Acts of Parliament, 1994 (India).
[5] Harriet Rosanne Etheredge, Assessing Global Organ Donation Policies: Opt-In vs Opt-Out, NATIONAL CENTER FOR BIOTECHNOLOGY INFORMATION, (Apr. 12, 2023, 10:28 PM), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8128443/
[6] UNOS, https://unos.org/about/national-organ-transplant-system/ (last visited Apr. 12, 2023)
[7] Nupur Nadir, Organ Transplantation Law In India, LEGAL SERVICES INDIA, (Apr. 12, 2023, 11:01 PM), https://www.legalserviceindia.com/article/l224-Organ-Transplantation-Law-In-India.html
[8] Shreya Tandon, The legality of organ donation in India, IPLEADERS, (Apr. 12, 2023, 11:07 PM), https://blog.ipleaders.in/legality-organ-donation-india/#:~:text=Organ%20donation%20and%20transplantation%20comes,organs%20for%20the%20therapeutic%20process
[9] Palak Kaushik, Analysis: India’s Organ Trafficking Problem, JUSTICE UPHELD, (Apr. 12, 2023, 11:10 PM), https://www.justiceupheld.org.uk/analysis-of-human-organ-trafficking-in-india/#:~:text=Victims%20of%20organ%20trafficking%20in%20India%3A&text=Selling%20organs%20in%20India%20is,uses%20the%20money%20for%20alcohol