Legal Uncertainties in India's Organ Transplant System: The Brainstem Death Dilemma

Source: The Hindu

Introduction 

Despite the Transplantation of Human Organs and Tissues Act, 1994 being in force for over three decades, India recorded only 0.77 organ donations per million population by 2023—far below the estimated need of half a million transplants annually. Central to these challenges is the lack of clarity surrounding brainstem death (BSD) certification, creating confusion for medical professionals, families, and legal authorities.

Types of Organ Transplants 

The 1994 Act recognizes two categories: 

• Live Donations: Organs removed from healthy living persons and transplanted to recipients. Requires legal authorization as donors permanently lose organ functionality. 
• Deceased Donations: Organs retrieved from persons whose brainstem is irreversibly damaged but vital organs remain functional. Legally contingent upon proper BSD certification—the primary focus of current legal uncertainties. 

What is Brainstem Death (BSD)? 

• BSD is recognized as a legal form of death under the 1994 Act.  
• It occurs when there is permanent disappearance of all evidence of brain function despite continued cardio-pulmonary function.  
• The Act mandates specific certification procedures involving qualified medical practitioners to determine irreversible cessation of brainstem function.

What are the Key Legal Uncertainties? 

Issue 1: BSD Definition Ambiguity 

• The Registration of Birth and Death Act, 1969 defines death as "permanent disappearance of all evidence of life," while BSD involves brain function cessation with continued cardiac activity.  
• No explicit provision confirms whether BSD certification suffices to register death under the 1969 Act, creating legal doubt about equivalence. 

Issue 2: Death Certificate Timing 

• Critical Question: When should the official time of death be recorded—when BSD is certified or when complete cardiac arrest occurs? 
• Current practice in most hospitals issues conventional death certificates only after cardiac arrest, even when BSD has been certified.  
• This creates uncertainty affecting medical decision-making, legal documentation, insurance claims, and criminal liability in trauma cases. 

Issue 3: Consent and Life Support 

The Dilemma: Should life support continue if the family denies consent after BSD certification? The law lacks clarity on: 

• Whether doctors can discontinue life support without family consent after BSD 
• Hospital obligations when families disagree with BSD diagnosis 
• Time limits for obtaining family consent

What Forms are Required for BSD Certification? 

• Form 10 (1994 Act): Certificate of BSD specifying exact date and time of certification. Should be certified in every hospital with ICU facilities conducting transplants. 
• Form 8 (Birth and Death Act, 1969): Consent form from near relatives stating "I have been informed that my relative has been declared brainstem dead/dead." The dual language creates confusion about whether BSD alone is sufficient.

What are the Hospital Registration Requirements? 

• Current Gap: BSD certification and organ harvesting occur only in registered transplant hospitals or Non-Transplant Organ Retrieval Centres. However, BSD can occur in any ICU due to trauma or hemorrhage. 
• Consequence: This severely restricts the donor pool, as many potential donors in non-registered ICU facilities cannot be certified for BSD purposes despite having necessary medical infrastructure. 

What Amendments are Needed? 

1. Clarify BSD Equivalence to Death:

• Explicitly approve BSD certification in Form 10 as sufficient for death registration. Record time of death when BSD is certified, not when cardiac arrest occurs. 

2. Expand Eligibility Criteria for Certifying Doctors:

• Remove the requirement that certifying doctors must have attended the deceased during final illness.  
• Any registered medical practitioner in hospitals should be empowered to certify BSD after following due protocols. 

3. PermitBSD Certification in All ICU Facilities: 

• Allow BSD certification in all hospitals with ICU facilities, even without transplant programs.  
• This would significantly expand potential donor identification and improve organ retrieval logistics. 

4. Resolve Timing and Consent Ambiguities:

• Provide clear guidance on when death certificates should be issued, whether life support can be discontinued after BSD without family consent, and time limits for family decision-making. 

Conclusion 

The discrepancy between India's 0.77 donations per million population and the need for half a million transplants annually demonstrates urgent need for legal clarity. The central challenge revolves around brainstem death certification—inadequately integrated with broader death registration laws.