A significant demand-supply gap plagues the market for organ donation in India. The country has one of the lowest organ donation rates in the world, resulting in the death of innumerable patients in need of organ transplants.[1] While a part of this problem can be attributed to lack of awareness among potential donors, the issue is exacerbated by legislative ambiguity and regulatory shortcomings. The law on organ donation in India is primarily governed by the Transplantation of Human Organs and Tissues Act, 1994 (as amended in 2014) (“Act”), read with the Transplantation of Human Organs and Tissues Rules, 2014 (“Rules”).
An Overview of the Law and Brain Stem Death
The Act and the Rules were enacted to eliminate trafficking and prevent commercial dealings in human organs. However, several questions seem to remain unaddressed, resulting in shortage of organs for patients-in-need, lack of accessibility to available organs, exploitation of living donors, lack of clarity on eligibility of donors, and fatal delays in approvals. Perhaps the most crucial of these issues is the provision of ‘brain-stem death’ in the Act and the Rules, which forms the primary focus of this blog.
The brain stem is responsible for regulating most of the body’s integral functions like heartbeat, blood pressure, breathing and swallowing.[2] Brain-stem death may be caused through cessation of blood and/ or oxygen supply to the brain due to for instance, stroke, heart attack or cardiac arrest.[3] Once the brain stem has permanently stopped functioning, it is impossible for the patient to regain consciousness, even if a ventilator is used.[4] Having said that, the determination of brain-stem death is an ambiguous topic, requiring a negative test of ruling out other conditions.
Recently, the High Court (“HC”) of Kerala[5] issued summons to a hospital and its doctors for allegedly declaring brain-stem death and transplanting the liver of a patient in violation of the law. The HC order has revived the spotlight on the difficulties facing the legal framework for organ donation in India, and the need for legislative clarity in this regard.
Present Legal Framework
The Act provides for two broad categories of organ donors – living and deceased. A living donor can donate under three situations, i.e. to “near relatives”[6] defined under the Act as spouse, siblings, parents, children, grandparents and grandchildren[7]; to persons other than near relatives because of “affection or attachment” after approval from the Authorization Committee (“AC”)[8]; and in case of swap donations[9].
As for deceased donors, the donor, at any time before his death, must have provided consent unequivocally in writing in the presence of two or more witnesses (at least one of whom is a near relative), to donate any organ after death. Even in this scenario, the Act permits the person lawfully in possession of the donor’s dead body to halt the procedure if he believes that the donor had subsequently revoked his consent.[10] Thus, the Act provides for an opt-in system, where the presumption is that the deceased patient did not wish to donate his organs. That said, the Act also provides that where no consent was provided but no objection was expressed, the person lawfully in possession of the patient’s dead body may authorise the removal of the patient’s organs, subject to any objection from a near relative.[11] In any case, consent in the case of deceased donors cannot be made in favour of a specific recipient.
Crucially, a “deceased person” under the Act includes a person who has suffered “brain-stem death”.[12] The Act further defines brain-stem death as “the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified (under the Act)”.[13] The determination of whether a patient has suffered “brain-stem death” shall be made by a Board of Medical Experts (“Board”), consisting of the registered medical practitioner (“RMP”) in charge of the hospital, an independent RMP, a nominated neurologist/ neurosurgeon/ anaesthetist (as the case may be), and the RMP treating the patient whose brain-stem death has occurred.[14] When certifying brain-stem death, the Board is required to follow the procedure under the Rules.[15] This includes a series of tests including inter alia gag reflex, corneal reflex, apnoea test, pupillary size & light reflex, exclusion of reversible causes of coma, etc. The Rules further require that the patient be examined twice after an interval of about six hours.
Challenges under the Present Legal Framework
Brain-stem death
The recognition of ‘brain-stem death’ in India has only been provided in the context of organ donation law. While the Act recognises brain-stem death as actual death for the purpose of organ donation, legislations like the Registration of Births and Deaths Act, 1969 (“RBD Act”) and Indian Penal Code, 1860 (“IPC”) do not recognise brain stem death. The RBD Act defines “death” as “permanent disappearance of all evidence of life”,[16] while the IPC defines it as “death of a human being, unless the contrary appears from the context”.[17] Both being negative definitions, exclude ‘brain-stem death’, where despite the fact that the patient will never regain consciousness, the body and heart can be artificially oxygenated with a ventilator.
This legislative vacuum causes significant problems for doctors. Since brain-stem death is only recognised for organ donations, doctors cannot legally remove life support of a ‘brain-stem dead’ patient unless the patient’s organs can be removed for transplantation under the Act. This results in a precarious situation where a family is informed that the patient is “dead”, but if they refuse consent for organ donation and request that the body be handed over, their request to remove life support must be refused. On the one hand, removing life support could result in legal consequences for the doctor (including charges of criminal negligence/ murder) since there is no legal sanction under the RBD Act to withdraw life support for a ‘brain-stem dead’ patient, and on the other hand, there is an ethical obligation to contribute scarce medical resources (like ventilators and intensive care unit (“ICU”) wards) towards patients who have a chance to recover.
To address this issue, it would help to adopt a uniform definition of “death” across legislations, which includes both the circulatory and neurological criteria. This would involve the inclusion of ‘brain-stem death’ in the RBD Act, IPC and other relevant legislations. This is similar to the notification issued by the Government of Kerala, which expansively interpreted “death” under the RBD Act to include brain-stem death.[18] While an admirable step, leaving this determination to individual States ensures that medical science and law do not go hand-in-hand. Hence, what is required is an amendment to the RBD Act and all relevant legislations to delink brain-stem death from organ donation law.
The situation surrounding brain-stem death also suffers infrastructural problems. To diagnose brain-stem death, an ICU is required since it has the facilities (cardiac support, mechanical ventilation, etc.) to sustain the patient’s organ system. However, such ICUs are few, overburdened, and focused in big metropolitan cities. Consequently, hospitals have to choose between devoting ICU wards to patients who are in critical condition but can be saved, or to patients who are already “dead” but require the ICU for successful retrieval of their organs. Hospitals often opt for the former, neglecting brain-dead patients. The problem is – if such patients become donors, they require the same attention as other patients, to retain viability of their organs. However, due to issues of infrastructure, awareness, and inconvenience of approaching several stakeholders as required under the Act (Board, AC, near relatives, state authorities, etc.), such patients are often neglected.
Organ donation laws generally
An opt-in system for organ donation gives rise to several difficulties. Given the lack of awareness towards organ donation in India, several people who may otherwise have consented to donating their organs post-death, are presumed to dissent simply due to ignorance. This issue was noted by the Patna HC,[19] which observed that creating awareness would reduce the requirement to remove organs from living persons, since such organs would often be available through deceased donors.
Further, as stated above, the Act carves out an exception to the opt-in system – if during his lifetime, no objection was expressed by the deceased patient, then the person lawfully in possession of the dead body may authorise the removal of organs unless any near relative of the patient objects. Since ‘near relative’ includes several people, the procedure for obtaining consent may be cumbersome and result in loss of crucial time. Also, doctors may not be motivated enough to seek approval from all such relatives separately. There may even be situations where despite near-unanimous approval, a single relative may veto the organ donation, since the Act and Rules do not provide for any hierarchy of relatives.
In other situations, the near relatives of the patient may not even be present during diagnosis. While the Act permits removal of organs if the body isn’t claimed within 48 hours,[20] complications may arise if the relatives appear afterwards and object. This very possibility deters doctors from removing organs of an unclaimed patient.
To resolve these problems, the legislature may consider shifting to an opt-out model for organ donation as is followed in the United Kingdom,[21] to make the country more donation-friendly. Under this model, the deceased patient is presumed to have consented to organ removal unless proved otherwise.
Additionally, there is lack of access to data on organ availability. Under the Act, an advisory committee is required in every State, which will monitor the organ donation scenario in the State and aid with maintenance of an organ transplant registry.[22] However, most States lack such an authority, and in States where it is present (such as Tamil Nadu and Kerala), data collection is not uniform, thus resulting in low donation rates. To this effect, the Delhi HC[23] recommended setting up Organ Procurement Organizations with data banks to facilitate the dissemination of information on availability of organs. The court further explored the possibility of social incentives (such as preferred health care and recognition in the community) to promote organ donation. To ensure that this does not result in commercialisation of organ donation, these may be restricted to deceased donors and their families.
Furthermore, the Rules do not provide a mandatory timeline within which decisions must be taken by the AC – they simply require the AC to “expedite its decision-making process”.[24] It has been observed that lack of enforcement leads to severe delays in urgent and time-sensitive matters. This was noted by the Patna HC[25] which ordered that decisions must be taken within one month from the date of application. However, there is a need for a uniform and centralised timeline for disposal of applications made to the AC. This is crucial since such approvals are required in several situations, including swap donations, foreign donors/ recipients, donation for “affection or attachment”, etc.
Evidently, there is a long road ahead to make India more donation friendly. Issues of awareness, infrastructure, legislative ambiguity and procedural delays severely hinder the process of organ donation. As a result, many deceased persons are wrongly presumed to have refused consent for removal of their organs; many living donors lose organs which may have otherwise been available from deceased donors; and many patients-in-need are deprived transplants. The legal, ethical and logistical problems concerning ‘brain-stem dead’ patients, also require attention. In the short term, increasing awareness, expanding platforms to express consent, establishing a central repository to track organ availability, and imposing mandatory timelines on the AC, would go a long way in substantially improving the public health and donation scenario in the country.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
[1] https://www.hindustantimes.com/lifestyle/health/why-does-india-have-so-few-organ-donors-101686797945608.html
[2] https://www.nhsinform.scot/illnesses-and-conditions/brain-nerves-and-spinal-cord/brain-stem-death#:~:text=Brain%20death%20can%20occur%20when,the%20heart%20is%20suddenly%20blocked
[3] Id.
[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1116089/
[5] Order dated May 29, 2023 in Dr. S. Ganapathy v. Lakeshore Hospital & Ors., Crl. M.P. No. 1004/2021.
[6] Under Section 9(1) of the Act.
[7] Defined under section 2(i) of the Act.
[8] Under section 9(3) of the Act.
[9] Under section 9(3A) of the Act.
[10] Under section 3(2) of the Act.
[11] Under section 3(3) of the Act.
[12] Defined under section 2(e) of the Act.
[13] Defined under section 2(d) of the Act.
[14] Under section 3(6) of the Act.
[15] Provided in Form 10 appended to the Rules.
[16] Defined under section 2(1)(b) of the RBD Act.
[17] Defined under section 46 of the IPC.
[18] Notification dated 19.01.2020 bearing G.O. (Ms) No. 7/2020.
[19] Shambhu Nath & Anr. v. State of Bihar, Civil Writ No. 14947 of 2019.
[20] Under section 5 of the Act.
[21] https://www.organdonation.nhs.uk/helping-you-to-decide/about-organ-donation/faq/what-is-the-opt-out-system/#:~:text=All%20adults%20in%20England%20are,an%20%27opt%20out%27%20system.
[22] Rule 30 read with Rule 32 of the Rules.
[23] Balbir Singh v. The Authorization Committee & Ors., AIR 2004 Del 143.
[24] Under rule 23 of the Rules.
[25] Shambhu Nath & Anr. v. State of Bihar, Civil Writ No. 14947 of 2019.
