The demand for organ transplants surpasses the available donors, leading to the emergence of illicit practices like the commercialization of organ transplantation. In response, legislative measures were introduced to curb these activities. The legal framework for organ donation in India is primarily outlined in the Transplantation of Human Organs and Tissues Act, 1994 (as amended in 2014), along with the Transplantation of Human Organs and Tissues Rules, 2014. These laws aim to eradicate trafficking and prevent the commercial trade of human organs.
Brain Stem Death
Brain stem death is a crucial consideration in organ donation. A living individual has the option to become an organ donor and authorize the extraction of any organ or tissue for therapeutic purposes during their lifetime, following the guidelines outlined in Section 3 of the THOT Act 2014. Additionally, organ removal is permissible after the declaration of brain stem death.
The act defines “brain-stem death” as “the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified under sub-section (6) of section 3 of the act;”[1]
Under the act the definition for “deceased person” is defined as “a person in whom permanent disappearance of all evidence of life occurs, by reason of brain-stem death or in a cardio-pulmonary sense, at any time after live birth has taken place;”[2]
Certification of “brain-stem death” in a patient requires evaluation by a Board of medical experts. This board includes the registered medical practitioner overseeing the hospital where the death occurred, an independent registered medical practitioner nominated by the initial practitioner, and a neurologist or neurosurgeon nominated by the registered medical practitioner. Suppose a neurologist or neurosurgeon is not accessible. In that case, the initial practitioner may nominate an independent registered medical practitioner, surgeon, or physician, along with an anesthetist or intensivist, ensuring they are not members of the transplantation team for the recipient.[3]
However, the determination of brain death remains a controversial topic. In 2023, the Kerala High Court summoned a hospital and its doctors for declaring a patient dead without conducting an Apnoea Test, subsequently transplanting the liver to a Malaysian National.[4]
Types of organ donation
There are two primary categories of organ donation:
i) Living Donor Organ Donation: During their lifetime, an individual can contribute specific organs to benefit others. This includes the option to donate one kidney (as the remaining kidney can sufficiently maintain bodily functions), a portion of the pancreas (with half being adequate for sustaining pancreatic functions), and a segment of the liver (with regeneration occurring in both the recipient and donor over time).
A Living Donor is an individual, aged 18 or older, who voluntarily consents to the removal of one or more organs and/or tissues during their lifetime, following prevalent medical practices for therapeutic purposes.
Subcategories of living organ donation include:
Living Near-Related Donors: Human organs or tissues removed from a donor before their death cannot be transplanted into a recipient unless the donor is a near relative of the recipient.[5]
section 2(i) of the act defines “near relative” as “spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter”
Living Non-Near Relative Donors: These donors, not near relatives of the recipient, contribute organs out of affection, attachment to the recipient, or for special reasons.
SWAP Donors: In cases where a living near-relative donor is incompatible with the intended recipient, a provision for swapping donors between two pairs is possible. This occurs when the donor from the first pair matches with the second recipient, and vice versa. However, this is only permissible for near relatives as donors. If a non-relative donor wishes to authorize organ removal for a recipient based on affection or special reasons, prior approval from the Authorisation Committee is necessary.[6]
ii) Deceased Donor Organ Donation: After (brain-stem/cardiac) death, an individual can donate multiple organs and tissues, which continue to function in another person’s body.
A Deceased Donor can be anyone, regardless of age, race, or gender, who becomes an organ and tissue donor after their death (brainstem/cardiac). Consent from a near relative or a person in lawful possession of the deceased body is required. If the deceased donor is under 18, consent must be obtained from one parent or another near relative authorized by the parents. The determination of medical suitability for donation is made at the time of death.[7]
Punishments under the act
Section 18: Unauthorized Removal of Human Organs
Individuals providing services at a hospital engaged in such removal for transplantation purposes without proper authorization could face severe penalties, including incarceration for a maximum of ten years and a fine of up to twenty lakh rupees.
If the perpetrator is a registered medical practitioner, additional measures may be taken:
· The Appropriate Authority will report their name to the State Medical Council.
· The Council may initiate disciplinary action, including removing the practitioner’s name from the register:
· Three years for the first offense.
· Permanent removal for subsequent offenses.
Moreover, subsection (3) specifies that individuals rendering services at a hospital involved in the unauthorized removal of human tissue may encounter:
· Imprisonment for up to three years.
· A fine of up to five lakh rupees.
Section 19: Commercial Transactions Involving Human Organs
Anyone involved in activities such as making or receiving payment for the supply of human organs, seeking potential donors, or initiating transactions may face Imprisonment for a term not less than five years but up to ten years and A fine ranging from twenty lakh rupees to one crore rupees.
Section 20: Violation of Act Provisions and Rules
Section 20 deals with the punishment for violating any provision of this Act, any established rule, or any condition outlined in the registration granted under this Act, in the absence of specific penalties elsewhere. Individuals contravening such provisions may be subject to:
· Imprisonment for a term up to five years.
· A fine extending to twenty lakh rupees.
[1] section 2(d) of the Act.
[2] section 2(e) of the Act.
[3] section 3(6) of the Act
[4] Order dated May 29, 2023 in Dr. S. Ganapathy v. Lakeshore Hospital & Ors., Crl. M.P. No. 1004/2021
[5] section 9(1) of the act
[6] section 9( 3A ) of the act
[7] https://www.notto.gov.in/faqs.htm
Done By: Adithya Menon, 5th year B.A, LL.B(Hons.)
Veltech School of Law, Chennai
For Origin Law Labs
