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This article is written by Subhashmin Moharana, First year, 2nd Sem, NLUO, an intern under Legal Vidhiya

Abstract:

The purpose of this research paper is to examine the practices of organ donation in India, with a specific focus on the legal framework governing organ donation. Organ transplantation is a critical aspect of healthcare, offering a lifeline to patients suffering from end-stage organ failure. India, with its large population and diverse healthcare landscape, faces unique challenges in organ donation and transplantation. This research aims to provide an in-depth analysis of the legal aspects related to organ donation in India, including the existing laws, policies, and their implementation. By evaluating the current practices, gaps, and potential areas for improvement, this study will contribute to the development of a comprehensive framework for enhancing organ donation practices in India.

Keywords: Organ Donation, Practices of organ transplantation, Donor and Recipients of Organ donation

  Introduction

Organ donation and transplantation involve surgically removing an organ or tissue from one person, known as the organ donor, and placing it into another person, known as the recipient. This procedure is necessary when the recipient’s organ has failed or been damaged due to illness or injury. Organ transplantation is a significant advancement in modern medicine, but the demand for organs far exceeds the available supply. Tragically, every day, twenty-one individuals in the United States lose their lives while waiting for organ transplants, and over 107,380 people are currently on the waiting list. Various organs and tissues can be successfully transplanted to improve the health and quality of life for recipients. These include vital organs like the liver, kidney, pancreas, and heart, as well as non-vital tissues such as corneas, skin, bones, and heart valves. It’s crucial to note that anyone, regardless of age, can be a potential organ donor. When someone passes away, their medical history and age are evaluated to determine their suitability for donation, which is determined by the organ procurement organization.

By raising awareness about organ donation and transplantation and encouraging individuals to become donors, we can help bridge the gap between the supply and demand for organs. This has the potential to save numerous lives and enhance the well-being of those in need[i].

 Legal Framework for Organ Donation in India

In India, there are specific laws and regulations that govern organ donation and transplantation. These guidelines aim to ensure the proper and ethical handling of organ transplants. Here are some key provisions[ii]:

Living Donation: The law regulates who can donate organs without legal proceedings. Close relatives such as parents, siblings, children, and spouses are eligible. Recently, grandparents have also joined the government. Please prove your relationship. First relatives may be required to provide legal documentation and genetic testing. In the absence of first relatives, recipients and donors must obtain special permission from the Government Licensing Board. You will also be asked to appear for a committee interview to demonstrate that your motive for the donation is purely out of love or altruism.

Declaration of Brain Death: Brain death is defined by certain criteria. Two medical certificates issued by the relevant ministries in the hospital(doctors) are required for her, separated by six hours. At least one of her doctors must be a neurologist.

Accreditation Commission (AC) and Competent Authority (AA) Regulation: Each state or Union Territory of India has an Accreditation Commission and Competent Authority responsible for regulating transplantation activities.

• The Licensing Board ensures that the donation process between independent donors and donors is fair and transparent. The commission’s main task is to prevent the exploitation of organs for financial gain. They review joint applications from recipients and donors and conduct personal discussions to assess the veracity of donation motivations. The AC’s decision is based on the relevant provisions of “the Human Organ Transplantation Act (THO).”

• Competent authorities supervise organ harvesting, storage and transplantation. Hospitals need permission from authorities to carry out these activities. The AA conducts regular inspections to ensure adherence to standards, monitors post-transplant medical care, and investigates complaints and legal violations. Authorities issued him a five-year hospital license that could be renewed after it expired. A separate license is required for each organ. These laws and regulations are intended to protect the health of donors and recipients and to ensure that organ transplant procedures are performed with integrity and meet ethical standards.

Application Forms:

“The Transplantation of Human Organ Act” provides clear guidelines and procedures, which are basically 13 varried forms. The Central Government have amended the act to include “the Transplantation of Human Organs Rules, 1995”. Here are vital details from the rules:

Authorization for organ removal:

Forms 1(A), 1(B), and 1(C) specify authorization for the removal of a human organ for therapeutic purposes before the donor’s death. The new form is more comprehensive and requires supporting documents such as notarized ID, proof of address, marriage certificate and family photos. The

rule requires donors to obtain approval on the appropriate form (1(A) for next of kin, 1(B) for spouse, 1(C) for other relatives) before an organ can be harvested. It obliges doctors to make sure that they are doing. Donor’s mortal remains. Doctors should also check that:

  • Donor is in good health and able to donate organs. Physician must sign Form 2 certification.
  • Donor is a next of kin of recipient verified on Form 3 and has signed Form 1(A).
  • Donor and recipient submitted joint applications on Form 10 and were approved by their respective Competent Authorities. The donor-recipient relationship must also be evaluated to the satisfaction of the transplant center resident.

a) If the recipient is the donor’s spouse, the donor must provide a declaration evidencing that relationship by signing a Form 1(B) Certificate. Also, for recipients, you must use a Form 10 approved by the appropriate authority.

b) For donors who are not next of kin, the donor must sign Form 1(C) and file Form 10 with the recipient for approval by the Donation Approval Committee. These procedures and forms ensure that the organ harvesting, and transplantation process is carried out legally and with proper authorization from donors and relevant authorities.

Before removing human organs from a deceased person’s body, a physician must demonstrate that:

1. The donor must have at least two witnesses for the treatment, one of whom is the recipient. (Close relatives) must be present. Purposes for postmortem organ harvesting Purposes specifically authorized according to Form 5. There should be no reason to believe that the donor has revoked this approval.

2. The person who legally owns the body of the deceased has signed a Form 6 certificate.

When removing an organ from a person who has been declared brain stem dead, the resident must ensure that: Available.

2. If the person declared brainstem dead is under the age of 18, a certificate on Form 8 signed by all members of the Medical Advisory Board and a Power of Attorney designated on Form 9 by one of the parents. A signed certificate is required.

The New Rules also provides working guidelines for the Authorization Committee, which include the following:

1. When considering a transplant between genetically related individuals (close relatives such as parents, siblings, children above 18 years old), the committee should evaluate the following:

– Typing tissue and other relevant tests results.

– Evidence of the relationship, such as birth certificates and marriage certificates.

– Evidence of the proposed donor’s identity and residence, such as identity cards, passports, or other official documents.

– A family photo depicting the proposed donor, recipient, and another close relative.

2. If the above evidence does not conclusively establish the genetic relationship, additional medical tests may be required. These may include testing for Human Leukocyte Antigen (HLA) genes using accredited laboratories.

3. If the gene compatibility between the donor and recipient is still not established after testing, the same tests should be performed on both or at least one parent. If parents are not available, tests on available and willing relatives can be considered. If no suitable testing is possible, it will be deemed that they are not genetically compatible.

These guidelines ensure that proper evaluation and testing are conducted when considering organ transplants between genetically related individuals, helping to maintain the integrity and legitimacy of the transplantation process.

If a transplant is proposed for a couple, the fact and duration of the marriage must be evaluated by the attending physician at the transplant centre. This evaluation includes inspection of the child’s birth certificate with information about the marriage certificate, marriage photo, family photo, and parents. If the proposed donor and/or recipient are Indian citizens or non-citizens, regardless of whether they are next of kin, the Authorization Commission (AC) will consider such requests. In these situations, a senior embassy official from the donor’s country of origin must prove the donor-recipient relationship.

Authorisation commission (AC) evaluates whether there is any commercial transaction between them when they are close relatives. The following aspects are specifically assessed:

1. The explanation of the connection between the donor and the recipient and the circumstances that led to the offer.

2. The reasons why the donor wishes to donate.

3. Documentary evidence of their connection, such as proof of having lived together and old photographs showing them together.

4. Ensuring that there is no involvement of agents or touts.

5. Probing the financial status of the donor and recipient by requesting appropriate evidence of their occupation and income for the past three fiscal years. Any significant disparity between their statuses is evaluated to prevent commercial dealings.

6. Ensuring that the donor is not a drug addict or a known person with a criminal record.

7. Interviewing the next of kin of the proposed unrelated donor to ascertain their awareness of the intention to donate an organ, the authenticity of the link between the donor and the recipient, and the reasons for donation.

The Authorization Commission (AC) evaluates potential commercial transactions between close relatives involved in organ transplantation. They assess various aspects including the relationship between the donor and recipient, the motivations behind the donation, documentary evidence of their connection, ensuring no involvement of agents, examining the financial status of both parties, verifying the donor’s background, and interviewing the next of kin for unrelated donors. The AC provides a written explanation for approving or rejecting applications and imposes conditions such as medical examinations, psychiatric clearance, completing required forms, and video recording interviews. The final decision must be made within 24 hours and communicated through websites and bulletin boards. State-level ACs determine legal and residency status, while additional ACs can be established as needed. Members of the institution’s transplant team must not be members of the applicable AC. In metropolitan areas and large cities where the number of transplants at a particular transplant centre exceeds 25 transplants per year, an AC should be located within the hospital. Smaller towns should establish a commission at the state or district level if the district has fewer than 25 transplants per year.

The composition of a Hospital Accreditation Committee (AC) includes:

1. Hospital Medical Director or Medical Superintendent.

2. Two senior doctors at the same hospital who are not part of the transplant team.

3. Two members with high integrity, social standing, and reliability.

4. Minister of Health or nominee.

5. Director of Health Services or nominee.

Similarly, for State or District Level ACs, the composition includes:

1. Physician holding a Chief Medical Officer or equivalent position at a major state hospital in the county.

2. Two senior doctors from the district who are not part of the transplant team.

3. Two county seniors with an excellent reputation and integrity.

4. Minister of Health or nominee.

5. Director of Health Services or nominee.

Please note that these are general guidelines for the composition of the Hospital AC and State/District Level ACs and may vary based on specific regulations and requirements in different jurisdictions.

The Challenges to organ donation in India

The deceased organ donation rate in India is currently unusually low at about 0.34 per million[iii] people, which is significantly lower than rates in other developed countries. Several factors contribute to this situation.

1. Socio-Cultural Factors: In countries such as India, China and Japan, cultural and religious beliefs influence[iv] decisions regarding deceased organ donation. Concepts of ethics, religion and spirituality are tied to the idea of ​​life after death. Starting a discussion about organ donation can be difficult, especially for brain-dead donors. Religious concerns also influence attitudes toward organ donation.

2. Beliefs and myths: Public awareness of organ donation is lacking in India, which negatively impacts perceptions of organ donation overall. Superstitions such as the belief that people are born with missing organs (donated) or that tampering with the body disrupts the cycle of life, death, and regeneration contribute to negative attitudes. Many people in India, including some Indian medical professionals, are unfamiliar with the concept of “brain death” and its legal implications.

3. Lack of Effective Communication: Donors who are educated and understand the concepts of brain death and organ donation are more likely to effectively communicate their organ donation intentions to their families. However, in some cases, peer pressure and other factors cause people to sign donor cards without fully understanding the issues involved. This lack of knowledge could cause her decisions to be overturned before her death.

4 Lack of institutional support: The limited number of transplant centers with adequate staff and trained transplant coordinators is a major obstacle to death benefit programs, comprehensive dialysis programs, and research. Another challenge is the lack of an effective national health insurance plan. Hospitals lack clear procedures for determining brain death, and there are no competent transplant coordinators who can sympathetically contact families of potential brain-dead donors and obtain their consent for organ donation. Limited knowledge of organ donation, even within the medical community, hinders progress in this field.

5 Negative media portrayals: Negative media portrayals can undermine trust and undermine notions of deceased organ donation based on mutual trust and altruism.

Case laws Relating to organ donation.

S. Samson v. Authorization Committee for Implementation of Human Organ Transplantation [v]

In the case of S. Samson v. Authorization Committee for Implementation of Human Organ Transplantation, the petitioner, a lawyer with chronic renal failure, sought permission for kidney transplantation from a non-relative donor. The committee rejected the request based on suspected financial bonding. The court found the decision arbitrary and lacking proper reasoning, violating the Transplantation of Human Organs Act. The court set aside the decision, remitting the matter for re-examination, emphasizing the urgent need for transplantation. The writ petition was allowed with the direction to reconsider the application within three weeks.

Sonia Ajit Vayklip and Another; v. Hospital Committee, Lilavati Hospital and Research Centre and Others [vi]

Case: Writ Petition under Article 226 of the Constitution challenging denial of kidney transplantation approval.

Parties: Petitioner No. 1 (a tribal lady) and Respondents (Hospital Committee, Authorization Committee, and others).

Facts: The petitioner sought approval to donate her kidney to her younger brother. The Hospital Committee and Authorization Committee refused permission, citing the petitioner’s low IQ scores and kidney stones. The petitioner argued that she is not mentally retarded and provided evidence of being a near relative as defined by the Transplantation of Human Organs and Tissues Act, 1994. The petitioner’s medical team affirmed the suitability of the transplant. The respondent argued for the requirement of approval from the Authorization Committee of the State where the donor and recipient reside.

Decision: The court determined that if both the donor and recipient are near relatives as defined by the Act, no further enquiry into commercial elements is necessary. The court upheld the permissibility of kidney transplantation and instructed the Authorization Committee to reconsider the case.

Ranjeet Vishnu Mane v. Union of India and Others [vii]

Facts:

The petitioner, Ranjeet Vishnu Mane, sought permission to undergo a kidney transplant operation at Jaslok Hospital and Research Centre, with the organ being donated by his relative, Rupesh Shankar Mane. Ranjeet suffered from advanced kidney disease, and after unsuccessful attempts to find a suitable donor among other relatives, he found a willing donor in Rupesh. However, the DNA typing conducted at Sir JJ Group of Hospitals to establish their genetic relationship was inconclusive, leading to complications in processing the donation application. Ranjeet’s health condition deteriorated, and he requested the court to direct Jaslok Hospital to submit his proposal to the Directorate of Medical Education and allow the transplant procedure.

Decision:

The court recognized the human situation involved and expressed willingness to make necessary orders. However, it deferred to the clinical judgment and reports of Jaslok Hospital regarding compatibility. The court emphasized the importance of following applicable rules, regulations, and government regulations. The genetic relationship issue was left for the attending authorities at Jaslok Hospital to determine, and the court respected Jaslok Hospital’s assessment and decision. The court directed Jaslok Hospital to consider the suitability of the petitioner and the donor, forwarding the case papers to the Director of Medical Education. Copies of the order were to be sent to the relevant parties for compliance.

Conclusion

Consent is the most important thing in any law, thus Consent for donating organ is obviously vital in medical law. The evidence suggests that countries with presumed consent laws tend to have higher deceased donation rates. However, the effectiveness of presumed consent legislation depends on factors such as hospitals respecting the documented preferences of the deceased and the establishment of proper social support and organized procurement processes.

In conclusion, organ transplantation in India has witnessed considerable progress, with a total of 12,666 transplants[viii] performed in 2019, ranking the country second in terms of volume globally. While living donor transplants have been predominant, efforts are being made to expand deceased donation programs. Moving forward, it is crucial for all key stakeholders to collaborate closely and enhance support for healthcare in the public sector. Addressing cultural and religious barriers to organ donation is essential, and educational campaigns should target both medical professionals and the general population. Hospitals must establish expert infrastructure to identify potential donors and ensure optimal management. Fair and transparent organ allocation practices are vital to maintain public trust in the system. Therefore, the government should prioritize the implementation of deceased donation policies. To further advance deceased donation programs, opportunities in deceased organ transplantation should be expanded through dedicated teamwork. Collaboration with national and international societies can play a crucial role in achieving self-sufficiency in organ transplantation in India.

By overcoming sociocultural challenges, strengthening healthcare infrastructure, and fostering collaborations, India can continue to make strides in organ transplantation, improving the lives of countless patients in need.

References: –


[i] Bilgel, F. “The impact of presumed consent laws and institutions on deceased organ donation.” (2010) 13 The European Journal of Health Economics 1, 29–38. doi:10.1007/s10198-010-0277-8.

 

[ii] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2779960/ The Transplantation of Human Organ Act (THO) was enacted in India in 1994 to regulate organ donation and transplantation. Despite its implementation, organ commerce and scandals persist. Some states have made progress in developing deceased donation programs, with hospitals and NGOs playing a crucial role. Address organ shortages developed countries are exploring alternative ethical options. India’s deceased donation rate remains low, but recent government initiatives aim to streamline the process and curb organ commerce. Upholding legal and ethical principles in organ transplantation is essential, not just for the present but also for emerging sciences like cloning and stem cell research.

[iii]  Srivastava AK, Taly AB, Gupta A, Murali T. “Holmes tremor: Report of 17 cases.” (2018) 66 Neurology India 316. (https://www.neurologyindia.com/article.asp?issn=0028-3886;year=2018;volume=66;issue=2;spage=316;epage=322;aulast=Srivastava )This article talks about the challenges India faces in organ donation. Organ transplantation has transformed countless lives worldwide. However, there is a shortage of organs available for transplantation. Encouraging deceased organ donation, particularly from victims of fatal accidents, could significantly help meet the demand. Challenges include sociocultural factors, beliefs, lack of communication, organizational support, and negative media portrayal. India has initiatives like the Indian Network for Organ Sharing, Transplantation of Human Organ Act, and stringent criteria for organ retrieval and transportation. Efforts to promote organ transplantation continue through awareness campaigns and improving existing initiatives.

[iv]  V. Poreddi, TS. Sunitha, S. Gandhi, R. Thimmaiah, and S. B. Math. “Knowledge, attitude and behaviour of the general population towards organ donation: An Indian perspective.” (2016) 29 Nat’l Med. J. India 5. This study advocates for public education programmes to increase awareness among the general population about the legislation related to organ donation

[v] S. Samson v. Authorization Committee for Implementation of Human Organ Transplantation, 2008 SCC OnLine Mad 317

[vi] Sonia Ajit Vayklip v. Hospital Committee, Lilavati Hospital and Research Centre, 2012 SCC OnLine Bom 64

[vii] Ranjeet Vishnu Mane v. Union of India, 2022 SCC OnLine Bom 8215

[viii] Kute, Vivek B. DM, FRCP1; Ramesh, Vasanthi MS2,3; Rela, Mohamed MS, FRCS, DSc4. “On the Way to Self-sufficiency: Improving Deceased Organ Donation in India.” Transplantation 105(8): p 1625-1630, August 2021. | DOI: 10.1097/TP.0000000000003677. https://journals.lww.com/transplantjournal/Fulltext/2021/08000/On_the_Way_to_Self_sufficiency__Improving_Deceased.1.aspx In India, organ transplantation heavily relies on living donor procedures (80.3%) for kidney and liver transplants, resulting in fewer heart, lung, pancreas, and small bowel transplants. There is a gender imbalance, with the majority of transplant recipients being male (81%), while most donors are female (78%). Follow-up for living donors is limited, and recipient outcomes vary. Transplants primarily occur in private hospitals, which are nearly twice as expensive as public sector hospitals.


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