Essential Must-Know Legal Aspects of Organ Donation

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Highlights:

The Transplantation of Organs Act, 1994 and its subsequent Rules and Amendments is the supreme statute governing the practice of organ transplantation in India
Certain factors such as consent, non-objection of kin, brain death certificate etc. that must be satisfied by the donor and the medical practitioner handling the transplant case
Although the Act and its additions have attempted to be comprehensive, there are still efforts to be made

Transplantation is a medical operation where an individual's organ, tissue, or collection of cells is extracted from their body (the donor) and placed into another person's body (the recipient) or relocated to a different location within the same person's body. The procedure of taking healthy organs and tissues from one person and giving them to someone else is life saving and complex. Obviously, considering the sensitivity of the procedure, there should be clear guidelines and procedures for organ transplantation in India.

Thus, the Transplantation of Human Organs Act (THOA), 1994 and its subsequent Rules and Amendments, provides for regulation of removal, storage, and transplantation of human organs & tissues for therapeutic purposes and for prevention of commercial dealings in human organs & tissues. THOA and its subsequent amendment provide the legal framework for organ donation which is designed to protect the rights of both donors and recipients, and to prevent commercial exploitation of organs. The Indian government has taken significant steps in recent years to promote organ donation and raise awareness about the importance of this issue.

There are various aspects of organ transplantation that the Act covers. This piece covers the salient features of the process which are prescribed in the same such as, but not limited to, consent, brain death certification, living donation, prohibition of commercial transactions, Transplantation Authorization Committees (TACs) and punishment for violation of the Act.

Let us look at them individually.

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Consent

The principle of bodily autonomy gives rise to the requirement of consent in organ donation. The Courts have ruled time and again, laying down this vital parameter that needs to be fulfilled for one’s organ(s) to be taken and given to someone else. Organ donation can only be carried out with the explicit consent of the donor or their legal next of kin. The consent must be given in writing and witnessed by two people. Section 3 of the THOA states that no organ or tissue can be removed from the body of a living person without their explicit consent. If the donor is a minor, their parents or legal guardians must provide consent. It also stipulates that in the case of a deceased donor, the consent of the next of kin is required before any organs or tissues can be removed.

Brain Death Certification

The principle of the "dead-donor rule" necessitates that organs for transplantation should be removed only after a patient has been declared dead. To allow for the donation of life-sustaining organs in the case of patients with severe neurological injury, the concept of brain death was developed. The concept of brain death is crucial to the current methods of obtaining organs for transplantation as it provides justification for the removal of organs from bodies that still have blood flow and breathing, thereby preventing damage to the organs due to lack of oxygen.

For organ donation to take place, the donor must be certified as brain dead by a team of doctors. The certification process is strictly regulated by law. The process of declaring brain death and obtaining a brain death certificate is governed by the Indian Council of Medical Research (ICMR) guidelines on "Standards of Practice in Brain Death Determination." The guidelines specify the clinical tests that need to be conducted to establish brain death, including the absence of brainstem reflexes, the absence of spontaneous breathing, and the absence of response to pain.

Once brain death is confirmed, a brain death certificate is issued by a team of medical experts. This certificate is necessary for the legal removal of organs for transplantation. The family's consent is also required for organ donation, and the Act specifies that the consent should be given in writing. According to Section 5 of the THOA, a registered medical practitioner, along with a team of medical experts, must conduct the aforementioned series of tests to determine whether the patient is brain dead.

Prohibition of Commercial Transactions

The concept of transplant commercialism is frowned up, condemned and criminalized in various legal instruments such as the Declaration of Istanbul and the THO Act is no exception. The fact remains that the commercialization of organs does more harm more than good and this is due to the fact that it can create a market for organs, leading to a risk of exploitation and coercion. Organ donors may be pressured into selling their organs, or organ brokers may engage in unethical practices to obtain organs, such as kidnapping or trafficking.

The World Health Organization (WHO) in its statement on the sale of organs clearly states that it violates the Universal Declaration of Human Rights as well as its own constitution: “The human body and its parts cannot be the subject of commercial transactions. Accordingly, giving or receiving payment… for organs should be prohibited.” The WHO advises physicians not to transplant organs “if they have reason to believe that the organs concerned have been the subject of commercial transactions.”

The sale and purchase of organs is illegal in India. The THOA makes it an offense punishable by imprisonment for both the donor and recipient. Section 18 of the THOA prohibits the sale and purchase of organs and makes it an offense punishable with imprisonment and/or a fine. This Section also prohibits commercial dealing in organs, including brokering, and makes it an offense for anyone to advertise their willingness to buy or sell organs.

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Transplantation Authorization Committees

In order to regulate organ transplantation, each state in India has established Transplantation Authorization Committees (TACs). These committees oversee the registration of hospitals for performing transplantation and scrutinize cases of organ transplantation. Section 4A of the THO Rules, 1995 establishes the role of the Transplantation Authorization Committees (TACs) and the Act provides for the establishment of State and if necessary, district level TACs.

One of the committee’s crucial functions is to regulate the process of authorization to approve or reject transplants between the recipient and donors other than a first relative. This process involves verifying that there is no commercial transaction or middleman involved, examining the link between the donor and recipient, and evaluating the donor's reasons for donating. Documentary evidence and old photographs are also examined to establish the authenticity of the link. Additionally, the financial status of the donor and recipient is evaluated to prevent gross disparity, and the donor's drug addiction status is checked. Lastly, the awareness of the donor's near relative or any adult person related to the proposed unrelated donor is evaluated, along with any strong views or objections.

Punishment for Violation of Laws

The Act provides for punishment in the case of violation of the provisions stipulated in it.

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 appropriate authority 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.

As per 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.

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.

In conclusion, the Transplantation of Human Organs Act (THO Act) 1994 has been a significant step towards regulating organ transplantation in India. The Act has established a legal framework for the donation and transplantation of human organs and tissues, with the aim of preventing commercialization and promoting ethical practices. Despite the efforts made by the government and various organizations to implement the Act, there are still several challenges that need to be addressed. The lack of awareness about organ donation and transplantation, inadequate infrastructure, and the shortage of skilled healthcare professionals are some of the major issues that need attention. In addition, there is a need for stricter implementation of the Act, especially regarding the prevention of commercialization of organs. The government and regulatory bodies should take proactive measures to monitor the activities of hospitals and individuals involved in organ transplantation.

Source-Medindia