SN4 SHORT NOTE 5M ★ High-yield

Describe the legal and ethical aspects of organ transplantation in India.

Forensic Medicine · 2nd Professional — Para-Clinical

The Transplantation of Human Organs and Tissues Act

The transplantation OF human organs act 1994, amended in 2011 and renamed the Transplantation of Human Organs and Tissues Act, has three objects: to regulate the removal, storage and transplantation of organs; to recognise brain-stem death, which made deceased donation legally possible in India; and to prevent commercial dealing in organs
The prohibition of commerce is the heart of the Act, and it exists because organ sale in India was, before 1994, an open and exploitative trade in which the poor sold kidneys to the rich

Category of donor	Requirement
Near relative	Defined as spouse, son, daughter, father, mother, brother, sister, grandparent and grandchild. Requires the approval of the hospital authorisation committee and proof of relationship, including by DNA testing where necessary
Other than a near relative	Permitted only out of affection or attachment, or for other special reasons, and only with the approval of the authorisation committee, which must satisfy itself that there is NO commercial element. This is the provision most often abused
Swap (paired exchange) donation	Permitted where a near relative is incompatible, between two such pairs
Deceased donor	Consent given in life, or by the person lawfully IN possession of the body; in a medicolegal case the consent of the police or magistrate is also needed, and the autopsy must not be compromised
Minor	A living minor may not donate an organ except in exceptional circumstances specified by the Act

Brain-stem death certification requires a board of four — the registered medical practitioner in charge of the hospital; an authorised specialist; a neurologist or neurosurgeon nominated from a panel; and the treating doctor. Two sets of tests are performed 6 hours apart. none of them may be a member of the transplant team — the safeguard that removes any suggestion the diagnosis was influenced by the need for organs
Penalties — imprisonment and heavy fines for commercial dealing, for both the recipient and those who arrange it; and a doctor convicted is removed from the register for a specified period or permanently
Required request — the 2011 amendment obliges the treating doctor in an intensive care unit to inform the family of the option of donation when brain-stem death is diagnosed; and provides for a transplant coordinator in every registered hospital
NOTTO, ROTTO and SOTTO — the national, regional and state organ and tissue transplant organisations maintain the waiting lists and allocate deceased-donor organs

CLINICAL PEARL

The rule that no member of the certifying board may belong to the transplant team is the entire foundation of public trust in deceased donation. Families consent to donation only if they believe the death was diagnosed independently of any interest in the organs. A single credible allegation that a patient was declared dead to obtain a kidney would set the programme back a generation — which is why the safeguard is structural rather than left to individual integrity.

Ethical Issues in Transplantation

Exploitation of the poor — the Indian organ trade before 1994, and continuing violations under the guise of "affection or attachment", in which paid donors are presented as friends. The authorisation committee exists to detect this and frequently fails to
The definition of death — brain-stem death is not intuitive to families, who see a warm, breathing, perfused body. Explaining it takes time and skill, and doing it badly destroys consent
Allocation and justice — organs are scarce, and allocation must be transparent and based on medical criteria rather than ability to pay or influence
Living donor risk — a healthy person is subjected to an operation of no benefit to themselves, which is a unique situation in medicine and demands rigorous independent assessment of both consent and pressure
Coercion within families, particularly of women and of younger siblings, is real and is the reason the donor should be interviewed alone
Transplant tourism and cross-border commerce

Applied Aspects

Ask the family about donation when brain-stem death is diagnosed; the law now requires it, and families who are never asked frequently say afterwards that they would have agreed
Certify brain-stem death with the full board and the two sets of tests, and record them; shortcuts here are both unlawful and corrosive of the entire programme
Interview a living donor alone, and probe for pressure and for payment; a donor who cannot explain their relationship to the recipient consistently is the commonest sign of a commercial arrangement
Never accept or facilitate payment for an organ; it is a criminal offence carrying imprisonment and erasure from the register, and the doctor is the person the Act is designed to deter
In a medicolegal death, obtain police or magistrate consent before retrieval, and ensure the autopsy is not compromised; retrieval and medicolegal investigation can usually be reconciled with planning
Explain brain-stem death carefully and repeatedly; the family's understanding, not their signature, is what makes the consent real, and it takes more than one conversation

All questions in Medical Ethics, Consent & Negligence

Every Forensic Medicine chapter →