Brainstem Death & Organ Donation Reform

Context

1. India has one of the lowest deceased organ donation rates in the world – 77 donors per million (2023), compared to Spain’s 49.38 per million.
2. Around 5 lakh Indians die every year waiting for an organ.
3. A key bottleneck is confusion and legal ambiguity around Brainstem Death (BSD) certification, which affects organ donation and ICU resource use.

What is India’s legal framework on organ transplantation?

1. Transplantation of Human Organs and Tissues Act, 1994 (THOTA)
   1. This act governs both:
      1. Deceased donation – organs removed from a person with irreversible brainstem death whose heart may still be beating with life support.
      2. Living donation – removal of a functioning organ from a healthy person (e.g., kidney, part of liver).
   2. It makes Brainstem Death (BSD) a legal category of death and prescribes procedures to diagnose and certify
   3. This is important because doctors normally cannot remove organs from a living person without legal cover.

Two types of death in law

1. Registration of Births and Deaths Act, 1969 defines death as “Permanent disappearance of all evidence of life at any time after live birth.”
2. Transplantation of Human Organs and Tissues Act, 1994 (THOTA):
   1. Defines brainstem death as permanent and irreversible cessation of all brainstem functions.
   2. Defines a “deceased person” as someone in whom permanent disappearance of all evidence of life occurs either:
      1. by brainstem death, or
      2. in a cardio-pulmonary sense.
   3. Core idea in both Acts: “Permanent disappearance of all evidence of life” is equal to legal death, whether via:
      1. cardiac arrest or
      2. brainstem death.
   4. So BSD certification under THOTA is a valid legal death certificate, and is sufficient for registration under the 1969 Act.

Why is there confusion around Brainstem Death?

1. Key doubts in hospitals:
   1. If BSD is certified but family refuses organ donation:
      1. Should doctors ignore BSD and keep ventilator support till the heart stops?
      2. This leads to wastage of scarce ICU ventilators, especially in public hospitals.
   2. If family agrees to organ donation:
      1. After organ retrieval, many centres issue a second “conventional” death certificate (post-harvest).
      2. One person ends up with two death certificates – legally and ethically odd.
   3. Legally, this confusion is unnecessary because:
      1. The Acts already say BSD = legal death once “permanent disappearance of all evidence of life” has occurred.
      2. So only one death certificate – the BSD one – should be enough for registration and all legal purposes.

How do the Rules and Forms handle BSD and consent?

1. Registration of death – Form 4 (1969 Act)
   1. Form 4 for medical certificate of cause of death separates:
      1. Cause of death (disease, trauma etc.)
      2. Mode of death (heart failure, respiratory failure, etc., and “etc.” allows inclusion of BSD).
   2. BSD is essentially respiratory failure due to brainstem damage.
   3. So BSD fits within the existing legal and form structure – no amendment is strictly required to register BSD as death.
2. Consent – Rule 5 and Form 8 (THOTA Rules)
   1. Rule 5(1): A registered medical practitioner in an ICU “after certification of brainstem death” shall approach the near relative for consent.
   2. Rule 5(2): Same duty applies even in hospitals not registered for transplantation, if they have an ICU.
   3. Form 8 – Declaration & Consent Form:
      1. Starts with: “I have been informed that my relative … has been declared brainstem dead/dead.”
      2. Only after that comes the authorise / not authorise organ removal section.
   4. So, it can be concluded that:
      1. BSD must be identified and certified in every ICU, whether transplant hospital or not.
      2. Family consent is legally and ethically a step after death has been certified, not before.

What if the family refuses donation?

1. Law can only define death, not dictate:
   1. When to stop life support
   2. What to do with the body.
2. Practical approach:
   1. If family refuses donation:
      1. Doctor may continue life support briefly at family’s request,
      2. But it must be clear that death has already occurred, and time and date of death are final on the BSD certificate.
   2. If family agrees to donation:
      1. Life support continues only to preserve organs and organise retrieval.

Where is the law creating practical problems?

1. Restriction to registered hospitals – Section 14(1)
   1. Section 14(1) THOTA: No hospital may start any activity related to removal, storage or transplantation of organs unless registered under the Act.
   2. Result:
      1. In practice, BSD certification and organ retrieval happen only in:
         1. Registered transplant hospitals, or
         2. Registered Non-Transplant Organ Retrieval Centres (NTORCs).
      2. This contradicts Rule 5, which expects all ICU hospitals to certify BSD.
      3. Consequence: Many ICU patients who become BSD in non-registered hospitals are never certified, and so the potential donors are lost, shrinking the donor pool.
   3. Approval of doctors by Appropriate Authority (AA)
      1. Form 10 (BSD certification) requires 4 doctors, of whom 2 must be approved by the AA.
      2. Problems:
         1. Getting AA approval is bureaucratic and cumbersome.
         2. No clear special eligibility criteria are prescribed by AA.

• Most doctors see it as pointless paperwork not adding to their clinical practice.

1. Outcome: Many hospitals simply avoid BSD certification, again reducing potential for organ donation.

3. Missing time of death in Form 10
   1. Form 10 records BSD, but does not ask for “time of death”.
   2. Without time, the death certificate is incomplete for legal purposes (insurance, inheritance, medico-legal clarity).
   3. Kerala’s example (2020):
      1. State issued a clarification:
         Time of death = time when arterial pCO₂ reaches target in the second apnoea test (final step in BSD testing).
      2. Gives a clear, objective time of death for BSD cases.

Implications

1. Extremely low organ donation rates
   1. Without robust BSD certification across hospitals, India loses many potential deceased donors each year.
2. Wastage of ICU resources
   1. Ventilators kept on BSD patients indefinitely due to legal fear or confusion, while other critically ill patients may be waiting.
3. Ethical and legal confusion for families
   1. Two death certificates, unclear timing of death, and mixed messages undermine trust in the system.
4. Implementation gap despite good law
   1. On paper, THOTA and the 1969 Act do allow BSD as full legal death, but contradictions in Section 14 and AA doctor approvals create operational blockages.
5. Potential to significantly expand organ pool
   1. If all ICUs routinely certify BSD and can coordinate retrieval, deceased donation numbers could rise sharply, saving thousands of lives.

Challenges and Way Forward

Conclusion

India already has laws that recognise brainstem death as full legal death, but ambiguities in implementation and contradictions in rules are blocking organ donation and straining ICU resources. Clarifying BSD in practice, amending key provisions, and empowering all ICU hospitals to certify and act on BSD can transform India’s organ transplant system and save thousands of lives every year.