This article is written by Rachit Garg from the University of Petroleum and Energy Studies, Dehradun. The aim of this article is to give a brief introduction to the organ transplantation laws in India and specifies their shortcomings. 

Introduction

Transplantation of human organs is a huge success in the field of medical science and technology. In medical terms, ‘transplant’ is referred to as a process in which a portion/part of the body or a complete organ is removed from its original site of an individual and transferred to a separate site in the different individual. 

However, the number of patients desperately needing a transplant outnumbers the number of donors available, making it necessary for legislation to be in place to avoid illegal activity involving the commercialization of organ transplantation. 

History Overview

Organ transplantation in India has a shorter history compared to the most developed countries in the world. The kidney transplant was first performed in India in the 1970s. Transplantation activities picked up in the 80s and early 90s but it was mainly restricted to live donor kidney transplants in selected urban areas. Slowly, with new clinics coming up and an increase in the availability of trained staff, kidney transplantation activities increased. However, this led to the famous kidney trade in India in the 80s which caught a wide media coverage. Foreigners patients started to flock to India for transplantation from a paid donor. 

Considering the ongoing kidney scam in India, in 1991, the Central Government constituted a committee to make a report, which would be going to be the basis of legislation governing organ transplantation all over India. Moreover, it was also done to give a better definition of the term ‘brain death’. 

In 1994, The Transplantation of Human Organs Act (THOA) was promulgated by the government of India. Moreover, the Transplantation of Human Organs Rules followed in 1995 and were last amended in 2014, increasing the scope of donation and including tissues for transplantation. The act made commercialization of organs a punishable offence and legalized the concept of brain death in India allowing deceased donation by obtaining organs from brain stem dead person.

What is Brain Death?

Brain death is referred to as a state where all the brain functions have stopped working and cannot be reversed. However, in such a condition the heart may still be working due to the presence of oxygen because of the ventilator. But the patient can safely be pronounced to be dead in such a situation.

According to the definition in the THOA, brain death is a stage when all functions of the brain-stem have permanently ceased. The same has to be verified by the board of Medical experts.

THOA Rules mention certain pre-conditions to be fulfilled by medical practitioners before declaring a patient ‘brain stem death’. It has to be declared by the medical expert board after they examine the body twice and at an interval of about six hours.

Regulatory Bodies

Advisory Committee

1. Constituted under the chairmanship of administrative expert, who is not below the rank of the Secretary to the State Government for a period of 2 years to aid. 
2. Along with him/her, two medical experts possessing a medical postgraduate degree, with not less than 5 years of work experience in the field of organ or tissue transplantation. 
3. Committee’s purpose is to aid and advise the appropriate authority (AA).

Authorization Committee (AC)

1. The purpose of this committee is to accept or reject the application of donors (other than relatives) to ensure that he/she is not being exploited for monetary consideration by making a donation.
2. The AC scrutinizes the joint application made by the donor and the recipient and conducts an interview to ensure there is a genuine intention among them both and make sure that the donor understands the potential risks of the surgery.
3. A hospital can have its own AC if they carry out more than 25 transplants per year.

Appropriate Authority (AA)

1. Appropriate Authority’s purpose is to regulate human organs:

• Removal
• Storage
• Transplantation

The hospitals can only perform these functions after being licensed by the authorities.

2. However, the procedure of removal of the eyes of a dead donor is not required and is not governed by the authority and does not require licensing procedures. 

3. The functions of the AA include:

• Inspection and registration of hospitals for transplant surgery,
• Enforcement of required standards for the hospital,
• Conduct regular inspection of the hospital to examine the quality of transplantation and follow up medical care of donor and recipient, and
• Conduct an investigation for any breach of the Act.

4. The AA issues a license to a hospital for a period of 5 years and after that it needs to be renewed. Each organ requires a separate license. 

Competent Authority

1. It means the head or committee made by the institute carrying out the transplantation.
2. Any member from the transplant team can be its member.
3. It gives permission for the near-related transplants only.

Types of Donors

According to the Transplantation of Human Organs Act, the donors can be categorised into three types:

Living Donors

A living donor is a person who is above the age of 18 years and has voluntarily authorized for the removal of his organ/tissue, during his lifetime. A living person can legally donate:

• One Kidney as the donor’s body is capable of functioning adequately with one kidney. 

1. A portion of Pancreas as half of the pancreas can adequately perform the pancreatic functions. 
2. A part of his/her Liver as the other segment of the liver can regenerate after some time for both, the donor and the recipient.

However, living donors can broadly be categorized into three types:

• Living Near Related Donors

Under this category, only immediate blood relations are accepted as donors, for example, parents, children and siblings. As per the THOA rule 2014, grandparents and grandchildren have also been included in the list. Moreover, spouses are also accepted as living donors under this category. However, they need to prove their relationship with the recipient by proper legal documents or medical genetic tests.

• Living Non-near Donors

In such a case, the donor is not related to the recipient in any way and is willing to donate out of affection and attachment towards him/her. Permission is required in such a case which is granted by the Authorization committee by appearing in an interview. 

• SWAP Donors

This is suitable for cases where the near-relative donor is incompatible with the recipient. Such a provision involves swapping of the donor when the donor of the first pair is a match with the second recipient and donor of the second pair is a match with the first recipient. However, is it only permissible in the case of near-relative being the donors.

Foreign Donors

In this case, only those foreign donors are permitted who are ‘near-related’ to the recipient. However, Indian living donors who want to donate to a foreigner, other than a near relative, are not permitted as per the act. In case a foreigner comes to India for transplantation, the embassy of the country of origin must grant such permission and must certify the relationship between the donor and the recipient.

Deceased/Cadaver Donors

A donation, being a source of organs, can either be made after brain stem death (brain death) or after cardiac death (when the patient’s heart stops beating). A person can give his consent during his/her lifetime, if he/she is more than 18 years of age and if he/she is willing to donate his/her organs after he/she dies. After certification of brain death of the patient, it has been now made mandatory for the medical practitioner to ask the patient’s near relative or the person being in lawful possession of the body about their plans of organ donation, even if the patient has already consented for the same during his lifetime. 

However, the cost of maintaining the body of the deceased person, retrieval of the organs or the tissue, their preservation and transportation will not be borne by the family of the donor and shall be borne either by the recipient or the institution as already declared by the respective state government.

Also, now a person has an option to give consent for the same while applying for his driving license. His/her preference would reflect on it.

Punishment under the Act

1. As per Section 18 of this Act, any person who is responsible for the removal of a human organ/tissue with the authority of doing so can be punished with imprisonment which can extend to 10 years and with fine which can extend to Rs. 20 lakhs. In case that person is a medical professional, his name will be reported by the AA to the State Medical Council to take appropriate action including removing his name from the register of the council for 3 years for the first offense and if he/she commits an offense subsequently, then remove it permanently.
2. As per the Section 19, if any person involves himself/herself in the commercial dealing of human organs then such person can be punished with imprisonment for a term not less than 5 years but can extend to 10 years and will also be liable for a fine which will not be less than Rs. 20 lakhs but can extend to Rs. 1 crore.
3. As per Section 20. If any person violates any other provision of this act, he/she can be punished with imprisonment for a term which can extend to 5 years or with fine which may extend to Rs. 20 lakhs. 

Current Scenario in India

1. To do a diagnosis of a brain death donor, an ICU is required because it has the facilities to sustain the other organ system of the patient. But, the problem is, such ICUs are few in number and are mainly located in big metropolitan cities. These are already overburdened, unstaffed and lack a central command structure to function effectively. So, on one side there is a patient who is dying, and on another who is already dead but needs proper attention for successful retrieval of body organs. This situation automatically makes the medical professionals give less priority to the brain dead patient. 
2. The act of obtaining consent(informed consent) from relatives can be troublesome. The doctor handling the treatment, might not be motivated enough to seek such consent from the relatives. In other cases, the patients may lack relatives or their relatives may not be present when the diagnosis of brain death is carried out. Although the Act gives the right to the medical practitioner for the removal of organs for a donation if the body isn’t claimed within forty-eight hours after death by its relatives. If the relatives of the person are traced after the duration and they object to the act, then it could be a huge problem. Moreover, the decision of organ donation is not taken by a single relative and the whole family may need persuasion which results in loss of crucial time.
3. Transplantation is a complex and expensive process and there is no state funding for the same. It has been noted that most of the deceased donation has been taking place in the private sector. Moreover, a large number of donors and recipients are from private hospitals. This is leading to an imbalance regarding accessibility, regardless of their ability to pay, as the majority of the organs are currently going to the rich and the same option is not available to the poor sector of the society. 

Conclusion

Organ transplantation is one of the biggest achievements in medical science and technology. However, the fruit to this success may not be available to all. Cadaveric donation in India, in its present form, largely benefits the rich and supports a tiny percentage of patients requesting it. It also has led to the exploitation of the poor. 

Therefore, though we actively aim to raise donation rates we must not lose sight of this big picture. Many of the ideas and principles in modern transplantation of deceased donors come from the developed West, where both social views and health systems vary from those in India. We, in India, need to build an equal, open and not oppressive framework. This will be a slow and challenging process, which may also entail linking to the bigger battle for an advanced and accessible healthcare system for all.

LawSikho has created a telegram group for exchanging legal knowledge, referrals and various opportunities. You can click on this link and join: