CRITICAL ANALYSIS ON ORGAN TRANSPLANTATION: INDIA AND USA

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This article is written by Neha Choudhary of 9^th Semester of Gitarattan International Business School, an intern under Legal Vidhiya

ABSTRACT

Medical innovation and advancements are crucial for every nature. Evolution is essential in all conceivable fields, but it is especially pivotal in medical research. Since the historical era, we have encountered numerous health issues due to which people lost their organs which eventually led to death. However, in modern times, many new technologies have made it attainable to not only treat fatal illnesses but also transplant organs. There are various times when people lost their lives due to organ failure but technologies have made transplantation feasible. Undoubtedly, the procedure for organ transplantation has been the most revolutionary advancement in history, but it has also been witnessed that these operations were utilized for commercial goals, leading to the implementation of certain rules.

Keywords: Organ Transplantation, Donation, Illegal Activities, Innovation and Technologies.

INTRODUCTION

There have been several instances where people’s lives were lost as a result of medical incapacity and a lack of healthcare. The death rate has grown in prehistoric times as a result of several lethal illnesses and other health problems. Due to the lack of current medical sciences and technology, the death rate increased. The endless evolution in the medical field has made it possible for us to treat even the deadliest virus and diseases. The medical breakthroughs we have now are beyond anything we could have ever dreamed of.

Over time, several medical procedures have changed, and several new technologies have been made available everywhere. The adoption of these innovations took several years and at present, we can cure the deadliest ailments. There are various technologies that have been advanced over time such as brain mapping and imaging with the aid of CT scan and MRI revolutionized in a manner that can scan the entire body and detect the irregularities within the body; angioplasty has been crucial in improving the quality of life and life expectancy of people suffering from heart-related illnesses; technologies for treating Alzheimer’s disease, spinal cord injuries, cancer immunotherapy, vaccination drives, organ transplantation in the case of organ failure and the most recent example would be vaccine for the deadliest Covid – 19 which everyone is aware of.

Organ transplantation is one of the radical innovations that came into existence in 1995 to outlaw the illegal practice of organ trading and trafficking. The procedure of organ transplantation elevates organ donation by the deceased or the living person. However, various amendments were proposed after certain commercialized practices under the umbrella of illegal kidney scandals unfolded. Various acts were implemented for the regulation of organ donation and transplantation with the aim to impose penalties and punishments on the violators of the act.

HISTORY

Organ transplantation was enacted under the Transplantation of Human Organs Act in 1994 to curb the illegal activities that were taking place under the blanket of organ donation. The act was implemented to promote organ transplantation and spread awareness to prevent deaths due to organ failure. Various penalties were imposed, however, criminal activities like kidney scandals were still taking place with the help of loopholes in the provisions and to curb these illegalities, various amendments were proposed in 2009 which passed in 2011.

Kidney transplantation was initially carried out in India in the 1970s, although only on live donors in a few urban regions. Patients from all over the world traveled to India for major transplants from paid donors as it evolved over time and kidney transplantations rose. The Central Government in 1991 constituted a committee for the regulation of organ transplantation and precisely defined the term ‘brain death’. The Indian government published The Transplantation of Human Organs and Tissues Act (THOTA) in 1994, the rules of which were implemented in 1995 and further expanded the definition of donation by including tissues for transplantation. The law made it illegal to sell organs, established the concept of brain death in India, and allowed for dead organ donation using the deceased person’s brain stem.

In the United States, the United Network for Organ Sharing (UNOS) has a contract with the U.S. Organ Transplantation System to manage the Organ Procurement and Transplant Network (OPTN), which is managed by the Health Resources and Services Administration, a division of the U.S. Department of Health and Human Services. It is a highly complicated system whose objectives are to enhance the supply of donated organs accessible for transplantation and to assure the efficacy, efficiency, and equality of organ sharing in the country’s system of organ allocation. Since 1987, the OPTN has solely worked with UNOS as a partner organization. [1]

To enhance access, equity, and transparency, the OPTN has suggested modifications to the organ transplantation system. The federal government has a plan to update the country’s organ donation process. To enable the de-monopolization of the infrastructure and introduce additional options to enhance the organization of the current system, the effort involves the implementation of competitive bidding to manage the OPTN contract.

Hospitals initially encountered several issues related to organ transplantation, one of which was organ waste. Both the technology to match an organ with a patient and the method to preserve an organ that wasn’t being utilized for a variety of medical reasons didn’t exist.

MILESTONES IN THE FIELD OF ORGAN TRANSPLANTATION

INDIA

Dr. RES Muthayya performed the first cornea transplant in 1948. He was successful in founding the first eye bank at the Government Ophthalmic Hospital and Regional Institute of Ophthalmology in Chennai.
Dr. P.K. Sen and his colleagues at King Edward Memorial Hospital in Mumbai performed the country’s first kidney transplant in May 1965. Despite problems, the kidney continued to function normally until the recipient’s death, which occurred 11 days later.
At Delhi’s Apollo Hospital, doctors A.S. Soin and Rajashekar performed India’s first liver transplant on 42-year-old Bharat Bhushan on November 6, 1998. Bhushan had a severe illness, and a business executive, whose liver was given, had been pronounced brain dead. For a further 13 years, Bhushan lived.
On August 3, 1994, at AIIMS, Delhi, a team of 20 surgeons under the direction of Dr. P. Venugopal successfully carried out India’s first heart transplant. The donor was a 35-year-old woman, and Devi Ram, 40, was the beneficiary. Devi Ram survived for a further 15 years.
The first lung transplant in India took place very lately. When an elderly person gave his lungs to Jayshree Mehta, age 41, a transplant was carried out at Hinduja Hospital in Mumbai.
The first pancreatic transplant performed in India took place in Chandigarh’s Post Graduate Institute of Medical Education and Research (PGIMER) in December 2014. Anju, a lady in her 30s, received the organ from Barnala, Punjab native and organ donor Ashok Kumar, age 45.
According to some reports, in the second century, the Indian physician Sushruta performed rhinoplasty.[2]

UNITED STATES OF AMERICA

Identical twins aged 23 underwent the first successful living donor transplant in 1954. At Peter Bent Brigham Hospital (now Brigham and Women’s Hospital) in Boston, Massachusetts, physician Joseph E. Murray and colleagues performed a kidney transplant on Ronald Herrick’s twin brother Richard who had chronic renal failure.[3]
At the University of Chicago in 1905, Alexis Carrel and Charles Guthrie conducted the first heart transplant. They have performed kidney and heart transplants in addition to limb replantation and thyroid gland transplantation as part of research to develop the vascular anastomoses technique.[4]
James D. Hardy, a surgeon from the United States who died on February 19, 2003, conducted the first lung transplant in history, saving John Russell’s life for 18 days. [5]
On June 11, 1963, the transplant was carried out at the University of Mississippi Medical Center in Jackson, Mississippi. At the University of Colorado-Medical School in 1963, Dr. Thomas E. Starzl performed the first liver transplant on a human. Unfortunately, because improper immune-suppressive medications were being used at the time, success was limited. Patients were only able to survive for a few weeks. But four years later, the first successful liver transplant was made possible thanks to the creation of affordable immunosuppressive drugs.[6]

STATISTICS: FACTS AND FIGURES

According to data, India has 140 non-transplant organ retrieval institutions and 550 transplant centers registered with state-appropriate authorities in 2019. According to reports, there were 1993 and 8613 living donors for liver and kidney transplants, respectively. In 2019, there were fewer transplants of the pancreas and heart, and a larger ratio of female donors (65.4 and 54.3 percent, respectively). 10,600 living donor transplants were performed, which is greater than the number of deceased donor transplants, or 2023. [7]

According to the National Organ and Tissue Transplant Organization (NOTTO), there are now 49,745 persons in India waiting for organ transplants. In addition, the NOTTO reported that there were 4,49,760 registered organ donors in the nation and that 15,561 organ transplants were performed there in 2022.[8]

According to the U.S. Health Resources and Services Administration statistics, although 95% of Americans favor organ donation, only 58% have registered as donors. The statistics state that there would be 41,356 organ transplants performed in the United States in 2021. With the second-highest number of transplants reported in 2019, this was the greatest amount ever. Additionally, the number of organ donors in the United States in 2021 was a little over 20,400. As of November 2022, there were little over 105,700 applicants awaiting organ transplantation. Ten percent of these candidates required a liver transplant, while over 85% of them were waiting for kidney transplants. [9]

LAW REGULATING ORGAN TRANSPLANTATION IN INDIA

In order to stop the illicit operations that were going on under the guise of organ donation, the Transplantation of Human Organs and Tissues Act was passed in 1994. The legislation was put into place to encourage organ transplantation and raise awareness of it in order to stop organ failure-related fatalities. Despite the imposition of different fines, unlawful actions such as kidney scandals continued to be committed using gaps in the laws.

Organ transplantation refers to the procedure of transplanting organs from one body to another. The individual giving the organ is referred to as the donor, and the person receiving it is referred to as the receiver/recipient. In order for the recipient to function normally, organ transplantation replaces the recipient’s damaged organ with the donor’s functional organ.

Organ transplantation has been a boon to medical technology; the majority of transplants is executed from the deceased and has saved the lives of millions of people who have had organ failure. Moreover, the blind population now has new hope thanks to corneal transplants from deceased donors. However, many people have indulged in illegal activities and heinous of them being kidney scams for commercial purposes which led to the enactment of the Transplantation of Human Organs and Tissues Act.

According to the act, transplantation can take place from a living person or deceased person, genetically related or unrelated, however, these transplantations must not be for commercialization. The donor is allowed to authorize the removal of the organ after his death for therapeutic purposes, however, the grant must be written with two witnesses.[10] The act strictly prohibits the removal, storage, and transplantation of the organs for any purpose other than therapeutic purposes.[11]

There are certain restrictions imposed on hospitals in reference to the removal, storage, and transplantation of organs. According to the act, no unregistered hospital shall be allowed to store, remove or transplant the organ, violating which shall have to face penalties. It also states that the medical practitioner cannot perform these activities at a place other than registered under the act. [12]

The appropriate authority is appointed under the act for the proper implementation and regulation of the act. The act to safeguard people from illegal practices in the guise of organ transplantation authorizes the appropriate authority and even imposes penalties. The Central and the State Government are empowered with the power to appoint officers as appropriate authority under the act. These authorities are granted powers to grant registrations or to suspend and cancel the registrations, to investigate the complaints filed under the act, to inspect hospitals periodically, to enforce standards prescribed for hospitals, etc. [13]

The act imposes certain penalties for the breach of the provisions of the act. The act penalizes the person performing transplantation without authority with imprisonment and a fine.[14] The act also penalizes the person for commercial dealings in human organs with imprisonment and a fine.[15]

LAW REGULATING ORGAN TRANSPLANTATION IN THE USA

The law that governs organ transplantation and prohibits illegal activities is National Organ Transplant Act 1984. The act was enacted in the USA to ensure safe and fair donation and distribution and ensure the availability of organs for potential recipients by widening the pool of prospective donors. Initially, in the United States, there was no law for the allocation and transplantation of organs from donors to recipients, due to which there was a lack of supply and commercialization of organs, and therefore, congress passed NOTA.

National Organ Transplantation Act (NOTA) was passed in 1984. The fundamental specifications for OPOs, the OPTN, and the Scientific Registry for Transplant Recipients (SRTR) were created by NOTA. Additionally, the NOTA instructed the Secretary of HHS to contract for the establishment of the Organ Procurement and Transplantation Network (OPTN), a private, non-profit organization with experience in organ procurement and transplantation. Additionally, NOTA forbid the transfer of human organs in exchange for money or other valuables, violators are subject to fines and/or incarceration.

According to the act, the organ procurement organization is required to carry out specific tasks like locating potential donors and initiating agreements, making arrangements for the acquisition, storage, and preservation of donated organs that adhere to the quality standards, ensuring that the medical criteria for setting up systems are followed to allocate donated organs equally and fairly among transplant patients, and making arrangements for the easy mobility and transfer of donated organs.

CRIMES AGAINST HUMANITY

Over the glossy layer of the provisions passed by the government, there exist the sickening layers of heinous crimes which take place globally. Organ trafficking and illegal surgeries have infiltrated global medical practice. Despite the availability of evidence of the illicit activities under the Acts, several crimes go unreported, a few of which are illegal kidney transplants for valued consideration, fatal infections and resultant deaths due to mismatched organs, illegal transplanting by unregistered medical practitioners, deaths due to post-operative infections, weakness or depression, etc.

Organ trafficking and illegal transplantation cause gross violations of Fundamental Human Rights guaranteed by the Constitution of India under Article 21. Although the Right to Health has not been explicitly mentioned under Part III of the Constitution, however, it guarantees the right over one’s body under Article 21 of the Constitution and provides safeguards to protect citizens under the Directive Principle of State Policy. The provisions of the Constitution and THOTA have protected the people on a large scale from horrific crimes. However, crimes are still at their peak due to poverty as a majority of the population is still in absolute impoverishment and thus indulge in crimes to meet their basic necessities.

According to a WHO study, India is the world’s top exporter of organs, and it is obvious that the majority of these exports fall into the category of illegal organ trade that results in organ trafficking. Since there is a rising demand for human organs on a global scale, organ-related crimes are also anticipated to rise significantly, especially against the poor and other vulnerable groups in society.[16]

Approximately 12,000 illegal transplants take place annually in the USA, the majority of which are kidney transplants (roughly 8,000), followed by liver, heart, lung, and pancreatic transplants. According to GFI, the prices offered to people for their organs vary considerably. For example, payments for kidneys allegedly range from hundreds of dollars for those living in less developed nations to up to $20,000–$30,000 in more wealthy nations. Some people might not get paid at all or could get less than what was initially negotiated. According to reports, those who donate organs may later pay high medical expenses or lose their jobs as a result of unsuccessful operations or unknown side effects. Patients routinely pay 500% to 1,900% markups, while recipients pay between $100,000 and $237,000 for organs. [17]

CASE LAWS

INDIA 1. Neha Devi v. Govt. NCT Delhi[18]

In this case, the petition was filed against the hospital as the petitioner was disallowed to donate the kidney to her father without her husband’s consent which was not possible due to sour relations with her husband. Delhi high court in its judgment held that spousal consent for organ donation is not required; the only requirement was for independent consent to be confirmed by a person other than the beneficiary.

Balbir Singh v. Authorization Committee[19]

In this case, a committee was formed to formulate guidelines for better implementation of the THOTA. The suggestions have been implemented by a change that broadens the meaning of “near relative” under the statute.

Mrs. N. Ratnakumari v. State of Odisha [20]

In this case, the court issued certain directives as the case revolved around the wrongful and forceful kidney transplantation one of which was that the court directed the state that if the donor and recipient belong to the state of Odisha, the organ transplantation operation shall not be conducted without the no objection certificate from authorization committee of Odisha.

UNITED STATES OF AMERICA

Adventist Health System v. U.S. Department of Health and Human Services[21]

The Hospitals filed a lawsuit to block the OPTN’s new policy, which fundamentally alters how donated kidneys are allocated to kidney transplant patients, because it violates both the Administrative Procedure Act (APA) and the Transplant Act.

The district court rejected the hospital’ request for a temporary restraining order and preliminary injunction, and the Eighth Circuit upheld this decision. After examining how the district court balanced the Data phase criteria, the court concluded that the Hospitals had not shown that their procedural APA claim was likely to succeed on the merits.

The court also agreed with the district court that the Hospitals had not shown that their argument that the adoption of the Fixed Circle Policy constituted an arbitrary and capricious government action was likely to succeed on the merits. Furthermore, the district court’s decision that the Hospitals’ one-year delay disproved their claims of irreparable injury was not an abuse of discretion, and the balance of the competing interests and the public interest favored rejecting the requested interim injunction.[22]

CONCLUSION

Medical discoveries and innovation are essential globally. Every imaginable discipline must take into account evolution, but medical research needs it the most. Since the beginning of time, there have been many health problems that have caused organ failure in humans, which ultimately caused death. The development of several new technologies, however, in contemporary times has made it feasible to both cure and transplant organs in patients who have terminal conditions. Although organ failure has claimed the lives of people on numerous occasions, transplantation is now a possibility thanks to technology. Organ transplantation is without a doubt one of the most revolutionary medical innovations in history, but it has also been observed that some of these procedures were carried out with ulterior motives, such as profit, which prompted the adoption of certain rules and regulations.

REFERENCES

[1] U.S. Organ Transplantation System – Its History, Present, and Futureavailable athttps://pubmed.ncbi.nlm.nih.gov/37437168/#:~:text=The%20U.S.%20Organ%20Transplantation%20System%20is%20administered%20by,maintain%20the%20Organ%20Procurement%20and%20Transplant%20Network%20%28OPTN%29 (last visited on 16th August 2023)

[2] The First Organ and Tissue Transplants available at https://www.donatelife.org.in/first-organ-and-tissue-transplants (last visited on 16th August 2023)

[3] The First Organ and Tissue Transplants available at https://www.donatelife.org.in/first-organ-and-tissue-transplants (last visited on 16th August 2023)

[4] History of Heart Transplantation: a Hard and Glorious Journeyavailable athttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5701108/#:~:text=The%20first%20heart%20transplant%20was%20performed%20by%20Alexis,reimplantation%2C%20thyroid%20gland%20as%20well%20kidney%20and%20heart (last visited on 16th August 2023)

[5] https://www.britannica.com/biography/James-D-Hardy (last visited on 16th August 2023)

[6] First Liver Transplant: The History Of Liver Transplantation available at https://fattyliverdisease.com/first-liver-transplant/ (last visited on 16th August 2023)

[7] Organ Donation and Transplantation in India in 2019available at https://pubmed.ncbi.nlm.nih.gov/34763630/ (last visited on 16th August 2023)

[8] Nearly 50,000 people waiting for organ replacement in India, says Centre available at https://www.newindianexpress.com/nation/2023/mar/28/nearly-50000-people-waiting-for-organ-replacement-in-india-says-centre-2560389.html (last visited on 16th August 2023)

[9] Number of organ transplants in the U.S. 1988-2022 available at https://www.statista.com/statistics/398481/total-number-of-us-organ-transplants/ (last visited on 16th August 2023)

[10] Section 3 of The Transplantation of Human Organs and Tissues Act, 1994

[11] Section 11 of The Transplantation of Human Organs and Tissues Act, 1994

[12] Section 10 of The Transplantation of Human Organs and Tissues Act, 1994

[13] Section 13 of The Transplantation of Human Organs and Tissues Act, 1994

[14] Section 18 of The Transplantation of Human Organs and Tissues Act, 1994

[15] Section 19 of The Transplantation of Human Organs and Tissues Act, 1994

[16] Organ Trafficking as a Criminal Offence in India-An analysis of the Indian Legal Framework: Jayanta Boruah

available at https://journal.indianlegalsolution.com/2020/10/15/organ-trafficking-as-a-criminal-offence-in-india-an-analysis-of-the-indian-legal-framework-jayanta-boruah/ (last visited on 16th August 2023)

[17] International Organ Trafficking: In Brief available at https://crsreports.congress.gov/product/pdf/r/r46996 (last visited on 16th August 2023)