Practical, legal lssues with brain death situation in India vis-à-vis Transplantation of Organs Act

brain1By Siddharth Awadhoot*

The whole concept of Brain death and Brain Stem death vis-à-vis the relevance of the same to organ donation is still very alien to India. Even though a law was passed in 1994 legalizing Brain Stem Death, there is not much that has been done in this regard. Despite having a medical and legal affirmation across the globe, the concepts remain unknown to many in India. Long before the world witnessed advancement in technology, it was commonly agreed that death occurred when breathing and heartbeats stopped; the soul was said to have left the body.

As the technology advanced it fell upon the shoulders of the Medical Institutions to redefine death, moving from an ancient cardio-respiratory diagnosis to a neurocentric diagnosis of death.[1] With the rise in technology being adapted in healthcare services there was yet another revolutionary rise in medico-legal sphere, in the late 1950s as the use of mechanical ventilators increased the physicians were shocked to witness many a cases where the brains of the patients were not functional but the other organs keep functioning. It was very difficult to declare a person dead in this situation.[2]

This led to a change in the nature of debates about human death; as the brain became nonfunctional, the definitions started revolving the condition of the brain and brain death came about as the clinically accepted death of a person. The whole clinical acceptance and legal declaration of Brain Death gradually evolved with the introduction of Intensive Care Units in the hospitals; it gradually came about as the final clinical expression of a brain catastrophe which leads to a total and irreversible stoppage of neurological functions, characteristics such as irreversible coma, absence of brainstem, reflexes and apnea.[3]

Harvard Medical School on Brain Death set up an Ad hoc committee which published a report in 1968 which stated, “The definition of Irreversible Coma.” The criteria for determining brain death as apneic coma, and absence of any brain-stem reflexes for 24 hours, was affirmed by an electroencephalogram.[4] The committee proposed a whole-brain formulation to define death. A major aim of Harvard criteria was claimed to be the avoidance of prolonged futile life-support and promoting death with dignity. After this report, brain death was widely accepted.[5]

In the past 30 years this concept has been judicially accepted by countries like UK, USA, Japan, Iran and Saudi Arabia.

Indian Legal outlook on Brain Death

There is no legal definition of death in India. Section 46 of Indian Penal code states,

“The word Death denotes death of a human being unless the contrary appears from the context.”

The section 29(b) of Registration of Births and Deaths Act, 1969, states,

“The permanent disappearance of all evidence of life at any time after live-birth has taken place.”

Transplantation of Human Organs (THO) Act was passed by Indian parliament in 1994 which adopted the UK system and legalized the Brainstem death. THO rules were laid down in 1995 that explain certification procedure for Brain Death.

Highlights of THO Act are:

  1. Statutory sanction to the concept of brain death.
  2. Regulation of removal, storage and transplantation of human organs for therapeutic purposes.
  3. Commercial dealings in human organs prevented

Team of four medical experts including,

(a) Medical Administrator In charge of the hospital.

(b) Authorized Specialist

(c) Authorized Neurologist/Neurosurgeon

(d) Medical Officer treating the patient.[6]

As healthcare is a state subject the Act had to be adopted by various states for the purpose of implementation. It was adopted by all states except Andhra Pradesh and Jammu & Kashmir.  The state of Maharashtra passed a resolution in 2012 making it mandatory to declare and certify “brain death”. The Government Resolution mandates hospitals registered under THO Act 1994 to certify and notify the brainstem death cases to Zonal Transplantation Coordination committee.[7]

The brain-death certification procedures have been laid down in THO Act 1994 and the THO Rules, 1995. Form 8 of THO Act and Rules prescribed as Brain-Death Certification format is to be utilized to certify brain-stem death.

It states that a team of four medical experts should include:

  • Medical Administrator In charge of the hospital.
  • Authorized Specialist
  • Authorized Neurologist/Neuro-Surgeon
  • Medical Officer treating the patient.

Amendments in the THO Act (2011) have allowed selection of a surgeon/physician and an anesthetist, if approved neurosurgeon/ neurologist is unavailable.[8]

Question asked in Lok Sabha about Transplantation of Organs

QUESTION: BY PRATHAP SIMHA AND SHOBHA KARANDLAJE

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

  • whether a large number of people are dying prematurely due to heart, liver, lungs, kidneys and pancreas complications and that many lives can be saved by timely transplantation of organs donated by others, if so, the details thereof;
  • whether the Government is aware that organ transplantation in the country faces red-tapism, social and cultural myths and if so, the details thereof;
  • whether the Government proposes to create awareness programme on organ donation and importance of overcoming myths and fears surrounding organ donation among people across the country and if so , the details thereof; and
  • the steps taken/being taken by the Government to support organ donation and transplantation less costly and without delay?”

ANSWER: THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI JAGAT PRAKASH NADDA):

“Exact data on the number of premature deaths due to heart, liver, lungs, kidneys and pancreas complications has not been compiled. However, there is a huge gap between the demand for and supply of human organs for transplantation. The present annual requirement and availability of commonly transplanted organs is assessed as below:
Requirement                      Availability
Kidney 2,00,000                 6,000
Liver 30,000                         1,500
Heart  50,000                      15

While no such complaints have been received by this Ministry, there are social and cultural issues that have a bearing on organ donation.

The Government accords a very high priority for improving awareness on donation of cadaver organs to bridge the gap between the demands for and supply of organs and to save the lives of a large numbers of persons suffering from end stage organ failure. With this in view, the importance of organ donation has been highlighted by the Hon’ble Prime Minister in ‘Mann Ki Baat’ Programme in October and November 2015.

Further steps have been taken to make organ donation easier including through provision of updated information to general public on NOTTO website, a 24×7 call center with toll free helpline number (1800-11-4770), launch of National Organ and Tissue Donation and Transplant Registry. Financial assistance has also been sanctioned for establishing four regional level organizations called Regional Organ and Tissue Transplant Organization (ROTTO) in the States of Tamil Nadu, Maharashtra, Assam and UT of Chandigarh and carrying out awareness and training of transplant coordinators.

Hospitals have been advised to display boards outside the Intensive Care Units and at strategic locations in hospitals reminding that the law requires the doctor on duty/transplant coordinator/counsellor to make inquiry and request for organ donation from the family members of brain stem dead persons. Financial assistance is also being provided under the National Organ Transplant Programme for hiring transplant coordinators in Hospitals and Trauma Centers. The Government has also involved religious leaders and Non-Government Organizations, for generating awareness about organ donation.

Government is implementing National Organ Transplant Programme to support organ donation and make transplantation less costly and without delay with following components:-

(a)Establishing National Networking including National Organ and Tissue Transplant Organization at National level, Regional Organ and Tissue Transplant Organization (ROTTO) at regional level and State Organ and Tissue Transplant Organization (SOTTO) in States;

(b) Maintaining National Organ and Tissue Donation and Transplantation Registry;

(c) IEC activities for improving awareness on organ donation;

(d) Provision of financial assistance to 100 needy and poor patients in Government hospitals every year for post-transplant immunosuppressant therapy;

(e) Financial support for maintenance of body of deceased donor when the organ is allocated to a Government Hospital; 

(f) Funding of two transplant coordinators @ Rs. 20000/- per coordinator per month and a computer set for each Government medical college and attached hospitals. Financial support for this component is also available for good performing private centers. 

(g) Support for training of staff involved in transplantation such as Transplant Surgeons, Transplant Physicians, Nurses and Transplant Coordinators; 

(h) Transplant facilities are provided at Government Hospitals at subsidized cost.
Financial Assistance is also provided to below poverty line patients under Rashtriya Arogya Nidhi for organ transplantation.[9]

Difference between Brain Dead and Vegetative State

The difference between Brain Dead and Vegetative state can be understood through the following table taken from a Medical Journal[10]:

Conclusion

“I believe in magic, I believe in miracles. I just don’t believe they occur in isolation.”

As it is clear from the data presented above that there is certainly lack of awareness and activism about Brain death vis-à-vis organ donation in India under the Transplantation of Human Organs Act, 1994. Even though it is the Act that legalized and adopted the concept and procedures related to brain death. But still it is not being used.

As it is clear, looking at the answer of the question asked in Lok Sabha about organ donation, that there is certainly shortage of Hearts, Lungs and Kidney available for transplantation, than what is required. The demand grows every day at a greater exponential than the supply. As the data suggests majority of the brain deaths occur in hospitals not registered under the Transplantation of Human Organs Act, 1994 and also it is there for a fact that the share of hospitals registered under the Act is very less than the number of hospitals in India.

So, even though states like Maharashtra have enforced rules of compulsory declaration it is still not going to give any exceptional results as there is a need to get all the hospitals registered under National Organ and Tissue Transplant Organization; if not all, majority of them. It is indeed a very important legislation in the health care industry but if not implemented on the ground level it shall never give the required results. When a patient dies in a hospital not registered under the Act, there is no obligation to declare him brain dead as the question of transplantation never arises. Moreover the awareness about the importance of Organ donation is also very low in India.

Barely 5% of the population has registered as a donor under the Act and hardly 20% of the requirements are met every year. One of the intents behind passing this legislation was to curb and gradually stop the black marketing of human organs which also gives way to human trafficking. The progress is slow on that foot as well, it is required to focus more on the implementation of the act on the ground level and increase the awareness about these advanced concepts amongst the general population of India. This can lead to a better sanguinity in the demand and supply of the human organs and save lives on time.

*Tenth semester, Institute of Law, Nirma University

Notes:

[1] Pallis C. Brainstem death;the evolution of a concept. Med L J. 1987; 55. p. 84–107

[2] Wijdicks EF. Brain Death. Philadelphia: Lippincott Williams and Wilkins; 2001. p. 175

[3] Machado C. The declaration of Sydney on death. Neurology M J. 2007. P. 68

[4] Report of Ad Hoc Committee of Harvard Medical School on Brain Death, 1968; 205:337. p. 40

[5] Wijdicks EF, Brain death worldwide: Accepted fact but no global consensus in diagnostic criteria. Neuro J. 2002. p.58

[6] Government of India. Ministry of Law, Justice and Company Affairs, Legislative Department New Delhi. [Act 42 of 1994]

[7] Government of Maharashtra, Public Health Department, Government Resolution No. MAP2012/C.R.289/ AROGYA Mantralaya; 2012.

[8] Government of India. Ministry of Law, Justice and Company Affairs (Legislative Department) New Delhi. Transplantation of Human Organs (Amendment) Rules. 1995, 2008 and 2011.

[9] Lok Sabha Unstarred question no. 1563(Answered on 04/03/2016)

[10] Indian J Crit Care Med. 2014 Sep; 18(9): p. 596–605.

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