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REVIEW ARTICLE
Year : 2021  |  Volume : 15  |  Issue : 3  |  Page : 260-265

Transplantation of human organs act: Act of transplantation – Time to act on the act! - Narrative review


Department of Nephrology, Gandhi Medical College, Hyderabad, Telangana, India

Date of Submission14-Jun-2019
Date of Decision18-Dec-2019
Date of Acceptance28-Apr-2021
Date of Web Publication30-Sep-2021

Correspondence Address:
Dr. Manjusha Yadla
Department of Nephrology, Gandhi Medical College, Hyderabad, Telangana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijot.ijot_19_19

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  Abstract 

When the transplant act was brought in by the Central Government of India, the number of centers performing organ transplants and the number of patients undergoing transplants were much lesser compared to the present-day statistics. Knowing that the shortage of organs is the driving force behind illegal organ trade, strategies for legal and ethical expansion of the donor pool should be framed. Although Transplantation of Human Organs Act (Amended 2011 and Transplantation of Human Organs and Tissues Act Rules 2014) included swap transplantation and laid down certain rules for empowerment of deceased donor organ transplantation, certain changes are the need of the hour to expand the donor pool. Safeguarding the physicians' security and the recipient and donor rights is of prime concern in the process of organ transplantation. The present Act needs certain changes which clearly define the legal definition of brain death, legal issues involved in brain death, ethical and legal means of expansion of donor pool, and objective assessment of altruism.

Keywords: Organ transplantation, Transplantation of Human Organs Act, Transplantation of Human Organs and Tissues Act


How to cite this article:
Yadla M. Transplantation of human organs act: Act of transplantation – Time to act on the act! - Narrative review. Indian J Transplant 2021;15:260-5

How to cite this URL:
Yadla M. Transplantation of human organs act: Act of transplantation – Time to act on the act! - Narrative review. Indian J Transplant [serial online] 2021 [cited 2021 Nov 29];15:260-5. Available from: https://www.ijtonline.in/text.asp?2021/15/3/260/327390


  Background Top


Transplantation of Human Organs Act (THOA) was brought in by the Central Government of India in 1994[1] to promote legal and ethical organ transplantations across the country in a uniform manner. This Act was adopted by all the states, and certain states have brought in changes suitable for their requirement. The Act mentions the registration of hospitals performing transplantations, the renewal of the registrations, and the prerequisites of the same.

Subsequently, the rules were released in 1995[2] wherein forms were introduced for different causes and applications.

With the expanding depths and vastness of organ transplantation, certain amendments were made in 2008[3] and in 2011,[4] wherein the concept of near relative was redefined and the entity of swap transplantation was introduced legally. In addition, the term and the fine for punishments for the offence were changed.

In 2014, for easy work policy, the Rules were redefined for workup and scrutiny of transplant case scenarios within the framework of Act of Transplantation. In this, 33 Rules were made,[5] with details mentioned for each entity in accordance with the THOA 1994. The basics of Transplantation of Human Organs and Tissues Act (THOTA) were described in an earlier issue of IJT.[6]


  Changes to Act Upon Top


The Act and Rules need to undergo further modifications to:

  1. Suit the requirement of the current Indian scenario
  2. Strengthening legal and ethical support in the concept of brain death
  3. Regularize the concept of medical tourism.


Suiting the current Indian scenario

To meet the ever-increasing demand for organs, the need to expand the donor pool seems inevitable. If this expansion is done with ethical standards and within the legal limits, organ trafficking would be near eradicated.

However, how to have a continuous donor pool with ethical standards and within the legal framework, which works in principles of distributive justice?

Few possible ways for expansion of donor pool are being practiced, which are associated with their own advantages and disadvantages [Table 1].
Table 1: Possible ways of expansion of donor pool

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  1. Does the introduction OPTOUT system solve the problem?


  2. Introduction of OPTOUT system[7] justifying the need and the demand would definitely curb the back door organ trade, which has been a successful model in countries such as Spain. However, in a recent study published in Kidney International, it was concluded that switching from OPTIN to OPTOUT may not increase the number of organ donations.[8] It is suggested to have strategies of long-term sustenance such as maximum utilization of extended criteria donors, utilizing the pledgers in a legal and ethical way rather than attention-seeking numbers of pledging[8]

    Spain which stands at 37 donations per million population is a democratic country.[7] India, being the biggest democracy, needs to think about a system to deal with the demand in a transparent and globally acceptable manner, instead of simple introduction of OPTOUT system. In addition, emphasis on awareness of organ donation in routine public life, education systems would fetch more faith in the transparency of the system rather than the projection of need based emphasis.

  3. Concept of mandated choice


Mandated choice is a system that enables competent adults to decide whether they wish to donate their organs after their deaths. Individuals are free to choose whether to donate and even which organs they would like to donate; what they are not permitted to do is to fail to register their wishes. Individuals can also choose to let their relatives have the final say. Unless they are granted this right, however, the relatives have neither power nor opportunity to veto an individual's decision, whether it was for or against donation.[9]

  1. Mandated choice may be made mandatory while applying for tax returns, vehicle licenses, and health benefit claims. In the Indian scenario, it may be asked while applying for UIADI/UPI/Passport Visa. UIADI is a successful system across all economic and social levels in the Indian subcontinent. Introduction of such system may enhance mandatory public awareness about organ donation, irrespective of wish for donation
  2. Encouraging SWAP transplantations: THOA 2011 permits for SWAP transplantation between near relatives only, which indeed further restrains the expansion of donor pool


    1. Inclusion of other than near relatives as part of SWAP needs to be thought about as this would definitely increase the donor pool. However, then, hitch lies in establishing the relationship. This may be done by the scrutiny of valid information such as income tax, PAN CARD Checks, and Department of Revenue Authorization. Moreover, evidence-based HLA/DNA profiling may be made mandatory to avoid illegal and unethical donors. With the available technology, the authenticity of submitted documents may be checked online. Steps of strong scrutiny in corollary with the checks made during the issue of a passport/visa system would definitely enhance faith in the system without embarking on unethical and illegal donors


  3. The terms such as SWAP, kidney paired exchange, and donor exchange program to be inserted under the Section 9(C)
  4. Research in transplantation science
  5. Modifying organ allocation policies to ensure:


    1. Maximal utilization and minimal wastage of all organs from high risk/marginal donors
    2. Cost optimization of transplantation procedure across the nation


  6. Act needs certain more amendments to suit the requirement of our population


    1. Section 9 (3A) makes a mention about organ donation by other than near relative out of affection and attachment. Evidence in the form of certificates is scrutinized by the Authorization Committee in accordance with the Rule 18 in THOTA 2014,[5] some of which may or may not be fool proof. This very lacuna of objective assessment of Affection or Attachment is the basis for increase in other than near relative donations. Means of checking the authenticity through online from the respective revenue departments should be done in every case scenario to curb the transplantations occurring beyond the scope of the Act
    2. Affection and Altruism can be assessed using certain questionnaires, which may be administered by the Psychiatrist. Self-reported Altruism Scale,[10] a 20-item self-reported questionnaire for Compassionate Love Scale,[11] a 21-item based questionnaire can be administered to the donor for a subjective documentation of grading of affection and altruism. Though the exercise appears tedious, the questionnaire administration may not yield the same result in all of them. Hence, it may be considered as a reliable tool for the unmeasurable entities of Affection and Altruism
    3. Or the permissions being given based on the assessment of Altruism, Affection, and Attachment should be curbed and the permissions to be extended to relations other than those defined in near relative definition with a clause to establish the claimed relation. This expands the donor pool to cousins, in-laws, niece, nephew, etc., which helps in further curbing the unrelated transplant
    4. Eventually, the objective evidence remains establishing the near or distant relationship through DNA profiling.[5] Though this is costly procedure, the benefits of transparency of donor being permitted to donate outweigh the undercurrents of illegal organ sale. Making such rules will curb the illegal and unethical transplants, thus ensuring the transparency in the global platform too.


Strengthening legal and ethical support in the concept of brain death

The deceased donor pool is a huge pool which, if utilized in a legal and ethical manner, would definitely meet up with the organ demand. In India, the organ donation rate is at 0.5 per million population.[12] Apart from lack of awareness and motivation, the major area that needs to be addressed is the legal protection for the doctors declaring brain death. Apprehension prevails among the medical fraternity that the brain death declaration may be sued as medical negligence. This is one of the major reasons for less number of declarations, despite the motivated patient kin. This is because of the less supporting areas in the law toward the concept of brain death, which include:

  1. Dilemma in definition of death
  2. Dilemma in time of declaration of death
  3. Definitive means of declaration of brain death


Dilemma in the definition of death

In India, legal definition for death as per Section 46 of Indian Penal Code is nonexistence of life unless contrary appears from the context.[13] The Registration of Birth and Deaths Act, 1969, defines death as permanent disappearance of life after live birth has taken place.[14] However, THOA Act defines brainstem death as the stage at which all functions of the brainstem have permanently ceased and is so certified.[1] Moreover, circulatory death is defined as complete cessation of functioning of cardiovascular system.

It may be prudent to redefine the definition of death in the Indian legal system taking the definitions of brainstem death and deceased person as mentioned in THOA as this exercise would solve the enigma around the definition of death. This may be in similar lines with the unitary definition given by Presidents Commission, USA, which includes both cardiopulmonary and brain death stating that an individual who has sustained either (i) irreversible cessation of circulatory and respiratory or (ii) irreversible cessation of all functions of brain including brainstem is brain dead.[15]

THOA 1994 with amendments in 2011 defined two entities related to death:

  1. Brainstem death means the stage at which all functions of the brainstem have permanently and irreversibly ceased and is so certified under subsection (6) of section 3
  2. “Deceased person” means a person in whom permanent disappearance of all evidence of life occurs, by reason of brainstem death or in a cardiopulmonary sense, at any time after live birth has taken place.


With the premise that death means disappearance of all evidence of reversible signs of life, the definitions of brainstem death and deceased person may be changed to following definitions:

  1. Brainstem death means the stage at which all functions of the brainstem have permanently and irreversibly ceased and cardiopulmonary function is maintained artificially and solely with drugs and ventilatory supports, the withdrawal of which would cease the cardiac and pulmonary function and is so certified under subsection (6) of Section 3
  2. “Deceased person” means a person in whom permanent disappearance of all evidence of reversible signs of life occurs, by reason of brainstem death or in a cardiopulmonary sense, at any time after live birth has taken place.


A unified definition for death to be included in the Act: Death is defined as biological irreversibility of function of brain or heart.

It is time to bring out an Act on Brain death and Cardiac death as – National Death Act, or Uniform Death Code (UDC), which would enforce uniformity in the identification and declaration of the process of brain death among all the 29 states and 7 Union territories. With the present laws and rules, organ retrieval and continuation of life support systems is different in different states.

National Death Act/UDC should provide protection for integrity of sustenance of life, if any, in a person with near loss of life while promoting the process of brain death declaration, resulting in the act of giving life to some other person in need. The intention of the Code should be to integrate all the state orders of brain death and give a common code, applicable across the nation.

The National Death Act/UDC should largely focus on the following areas:

  • Unified definition of death
  • Methods of brain death declaration supported by legal laws
  • Empowerment and strengthening of credentials of brain death team members.
  • Expansion of knowledge and research in brain death.


Unified definition of death which is medically and legally acceptable and synchronizing in terms

With the lack of clarity in the present definitions of brain death and methods of diagnosis of brain death, the issues pertaining to declaration of death are left to clinicians and the courts (case by case), which would only result in persistence of inconsistence. In JahiMacMath case, though patient was brain dead in 2013, she was not dead based on cardiopulmonary criteria till June 2018,[16] and it was observed that there is a gap between medical criteria and legal criteria for brain death. This medicolegal gap needs to be adjudicated, for the clinicians to carry on fool-proof process, thus benefitting the needy.

Clarity and certainty of brain death based on clinic-laboratory methods

Clinically, apnea testing is considered one of the confirmatory tests for brain deaths. Apnea test, being a clinical test, is a test done by clinicians to identify brain death for optimization of available resources to the needy patients, which in itself may be associated with lateral outcomes of cardiac arrythmia, sudden cardiac arrest, and hypoxia. Hence, the issue of whether informed consent needs to be obtained/information to family needs to be provided before doing apnea testing has become a hot issue for all bioethics researchers.[17] Therefore, it may be prudent to clarify the confusion about the utility and authenticity of apnea testing to avoid the unwarranted loss of faith by the public in the medical system.

Role of ancillary tests

As of today, ancillary tests are supportive. Do ancillary tests be labeled as confirmatory tests? The famous case of JuhiMacMath was declared brain dead based on all invasive investigations (which showed lack of cerebral perfusion) yet was continued on all life support systems as per the family's insistence for approximately 4.5 years after brain death declaration (declared brain dead on December 24, 2013, declared dead on June 22, 2018). This discrepancy between brain death and cardiac death should be abridged with medical clarity supported by legal guidelines. Continuation of heartbeat with all the supportive systems for prolonged period in those patients who have crossed the salvageable point should be introspected, and the guidelines are to be laid in the best interest of salvageable patients.

Dilemma in time of declaration of death

Cardiac function continues for short time after brainstem death. It is well known that cardiac function ceases either at the time of brainstem death or shortly after the brainstem death. This puts the treating physician at dilemma regarding the record of time of death (reader may refer to the famous case of JahiMacMath). It is time to redefine the time of death in medical terminology whether it is cessation of functions of brainstem including respiratory arrest, circulatory arrest, and/or cessation of cardiac function. This would put the medical fraternity at clarity regarding the time of declaration of death.

Cardiac death occurs after brain death. The period between two deaths may be minutes-hours-days. In the era of developing concept of brainstem death and declaration and the limited medical resources, the relevance of cardiac death and the time needed to wait for cardiac death to occur after the brain death need to be understood as the resources spent to maintain a brain dead patient till cardiac death are profound.

Inclusion of entity of brain death declaration in death certificate form of each state within the norms of Registration of Births and Deaths Act, 1969:

  • Brain death declaration: Done/Not done
  • If done, declaration time:


Brain death declaration as a norm before cardiac death declaration

Irrespective of organ retrieval and organ donation, brain death declaration if done on a regular basis in all the hospitals by the intensive care groups without the preamble of organ retrieval or organ donation, then a consistent policy and method of declaration would be understood by the medical fraternity as well as the society which would futuristically imply that the process of declaration of death consists of brain death declaration followed by cardiac death declaration.

In this background of inconsistency, states such as Tamil Nadu, Kerala, and Gujarat have issued Government orders for mandatory brain death declaration within the legal limits of THOA, which needs to be followed stringently to develop the concept of drain death declaration.

Finally, what should be the definition of death, which is scientific, legal, ethical, and valid.

Definitive means of brain death declaration

Worldwide, brain death declaration is done based on two-time apnea test apart from the absence of brainstem reflexes, both of which are clinical criteria. The procedure of brain death declaration, including the tests to be done, is clearly mentioned in Form 10 of THOTA 2014.

Though the definitive criteria have a mention in the Criteria for Brain death declaration by theAmerican Association of Neurology (AAN),[18] the ancillary tests, which include electroencephalogram, digital subtraction angiography, magnetic resonance angiography, cerebral scintigraphy, and transcranial Doppler, are done as per the indication. The ever-increasing list of these ancillary tests may not be replaced the clinical bedside criteria.[19] AAN recommends ancillary testing only if clinical examination cannot be fully done or if apnea test is inconclusive. Hence, video recording of declaration of brainstem death procedure and the substantiation by ancillary tests based on the indication may be prudent.

Procedure of brain death and the team declaring brain death have been clearly mentioned in the Act. All the deaths should go through the procedure of brain death declaration, irrespective of organ donation. Making brain death mandatory within the legal and ethical framework may enhance awareness not only among medical fraternity but also among public. The process of brain death declaration should be delinked with organ retrieval and organ donation.

Technology utilization in brain death declaration

  1. Artificial intelligence (AI) in brain death declaration


    • Role of AI in brain death declaration is vast. It has significant application in timely prediction of outcomes of severe brain injury.
    • Designing algorithms for clinical diagnosis of brain death
    • Precision of radiological diagnosis


  2. Establishment of skill labs for brain death declaration. Training may be imparted for a specified duration to all the members of declaration team. Creation of credentialing mechanism for doctors with a specified certification for a short duration would strengthen the doctor team members. Mandatory training of the emergency department nurses and other paramedical staff would increase the sensitivity and the radius of awareness of program
  3. Establishment of brain death research laboratory enabling the scientific community to understand the physiology of brain death and pathology of brain death. Cryonics is a specialized branch of science dealing with preservation of brain of experimental animals (such as pig), to understand the link between memory and mind.


Regularization of transplant tourism

Transplant tourism is of different models as defined by Shimazono[20] In Indian scenario, following types may be seen:

  • Foreigners coming to India for Transplant (Model II)
  • Indians traveling abroad for transplantation without donor (Model I)
  • Illegal travel of voluntary donors to foreign countries (Model III).


Voluntary donation of organs as part of commercial or illegal dealings is a punishable offence under sections 18.19 of THOA 2011. Hence, Model III is not legally applicable in Indian scenario.

For foreigners coming to India for organ transplant, the procedure is clearly defined in THOA and THOTA 2014, but the same is not defined for those going abroad for organ transplantation.

Under Rule 18 of THOTA 2014, authorization committees formed at the state level/district level/hospital level are expected to scrutinize the documents in cases of Other than near relative transplantations as well as foreign transplantations. Thorough scrutiny of prerequisite documents is done during the interview process. Although the process involves various documents in Indian pairs, it is not the same with foreign pairs. Permission for foreign transplants, irrespective of the pitfalls elicited during the interview process, is given based on the Form 21. Why is a near relative not available for organ transplant is not declared by the country of origin. Embassy of that particular country mentions the relationship only, not mentioning about the reason for lack of near relative donor. In addition, the following should be made mandatory during interview process

  • Treatment certificate from country of origin as to why a particular donor is being sent for donation, Especially when a near relative is not the prospective donor
  • Next of kin to be available mandatorily during interview process
  • Government approved language translator to avoid bias and other confounding factors compromising the standards of interview process
  • HLA profiling and DNA fingerprinting to be made mandatory in all Foreign transplants
  • Economic details of both the donor and the recipient.


The enthusiasm to promote medical tourism should not outweigh the ethical and legal standards of organ transplantation. Transparency is limited by logistics, cost-effectiveness, and the haste involved in getting the transplant done. Factors such as limited duration of visa period form a major hurdle for thorough scrutiny of the pair.

Concept of translator

Translator is the pivotal person in foreign transplant scenario. For the foreign pairs who do not speak or understand English, interview needs to be done with the help of translators. Translators are most often either employed in the place of transplantation or may be students from nearby universities. Whether true translation happens as the interviewer does not understand the language being spoken, which results in many leading questions and answers, as the same translator is available for interview of both the donor and the recipient. To avoid these, Government should take an initiative to appoint a group of translators in each language through the available foreign universities or teleinterview in case of nonavailability in the same city. This would help in curbing the vested interests of translators and also reiterates the stand of Government in case of foreign transplants.

Lack of foreign transplant registry

There are no data or registry maintained at state/center regarding the data of patients traveling abroad for transplantation. No objection from state authorization committee and an approval from Indian Embassy should be mandatory in these scenarios along with follow-up data of the recipients. In addition, though there is mention of Registry under Rule 32 of THOTA 2014, not all the states are maintaining Registry to be uploaded to NOTTO.


  Conclusion Top


Few aspects of the Act need to be modified suiting the Indian scenario, which in turn encourages ethical standards of organ transplantation.

Establishment of National Brain Death Act for a near-complete unified medicolegal definition of death, uniformity of the policy of brain death declaration in all states and Union territories, need for imparting training to all team members to strengthen the credentials, and introduction of modified mandatory choice system would empower the India status in global platform in a long way. In addition, the concept of transplant tourism/travel for transplantation needs to be redefined with transparency regarding foreigner transplants and transplantation of Indians abroad.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Transplantation of Human Organs Act; 1994. Available from: https://websiteindiacode.nic.in. [Last accessed on 2020 Oct 10].  Back to cited text no. 1
    
2.
Ministry of Health and Family Welfare Notification; 4th February, 1995. Available from: https://websiteindiacode.nic.in. [Last accessed on 2020 Oct 10].  Back to cited text no. 2
    
3.
Transplantation of Human Organs (Amendment) Rules; 2008. Available from: https://websiteindiacode.nic.in. [Last accessed on 2020 Oct 10].  Back to cited text no. 3
    
4.
Transplantation of Human Organs (Amendment) Act, 2011. The Gazette of India. Extraordinary; 28th September, 2011.  Back to cited text no. 4
    
5.
Transplantation of Human Organs and Tissues Rules; 2014. Available from: https://websiteindiacode.nic.in. [Last accessed on 2020 Oct 10].  Back to cited text no. 5
    
6.
Sahay M. Transplantation of human organs and tissues Act –”Simplified”. Indian J Transplant 2018;12:84-9.  Back to cited text no. 6
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7.
Willis BH, Quigley M. Opt-out organ donation: On evidence and public policy. J R Soc Med 2014;107:56-60.  Back to cited text no. 7
    
8.
Arshad A, Anderson B, Sharif A. Comparison of organ donation and transplantation rates between opt-out and opt-in systems. Kidney Int 2019;95:1453-60.  Back to cited text no. 8
    
9.
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Rushton JP. The altruistic personality and the self report altruism scale. Person Indirid Diff 1981;2:293-302.  Back to cited text no. 10
    
11.
Sprecher S, Fehr B. Compassionate love for close others and humanity. J Soc Pers Relat 2005;22:629-51.  Back to cited text no. 11
    
12.
Abraham G, Vijayan M, Gopalakrishnan N, Shroff S, Amalorpavanathan J, Yuvaraj A, et al. State of deceased donor transplantation in India: A model for developing countries around the world. World J Transplant 2016;6:331-5.  Back to cited text no. 12
    
13.
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14.
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Jonsen AR. The ethics of organ transplantation: A brief history. Virtual Mentor 2012;14:264-8.  Back to cited text no. 15
    
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Jahi McMath Death Could Have Costly Implications in Civil Case against Hospital, Doctors”. The Mercury News; June 30, 2018. [Last accessed on 2018 Jul 02].  Back to cited text no. 16
    
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Thaddeus Mason Pope. Brain death testing: Time for national uniformity. Am J Bioeth 2020;6:1-3.  Back to cited text no. 17
    
18.
Wijdicks EF, Varelas PN, Gronseth GS, Greer DM, American Academy of Neurology. Evidence-based guideline update: determining brain death in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2010;74:1911-8.  Back to cited text no. 18
    
19.
Wijdicks EF. Neurology of brain death. In: Brain Death. 3rd ed. New York: Oxford University Press; 2017. p. 25-73.  Back to cited text no. 19
    
20.
Shimazono Y. The state of the international organ trade: A provisional picture based on integration of available information. Bull World Health Organ 2007;85:955-62.  Back to cited text no. 20
    



 
 
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