A New Lease Of Life: The Need For Reforms In India's Organ Donation Laws

Plugging The Legal Gaps

The first and foremost question that arises with respect to DDODs is when exactly is a person considered 'deceased' under the Act. Does brain death suffice, or does the Act mandate cardiac death? Post a 2011 Amendment to the Act, it now covers both brain and cardiac death within its ambit. What is of relevance to us in the present analysis is Section 2(d) of the Act, which defines brain-stem death as the stage where all functions of the brain-stem permanently and irreversibly cease to exist. However, this description is at loggerheads with the definition of death in another legislation, the Registration of Births and Deaths Act, 1969. Section 2(b) of that legislation, defines 'death' as "the permanent disappearance of all evidence of life at any time after live-birth has taken place". The problem that arises from having two fundamentally different definitions of 'death' can be better understood through an example. Suppose a person experiences brain-stem death, but is still on ventilator support, then they will continue to show signs of life. A study showed that the heart's intrinsic electrical system can ensure that the organ keeps beating even after a person is declared brain-dead. An active heartbeat does not qualify as 'the permanent disappearance of all evidence of life', and hence, a brain-dead person can be considered dead under the 1994 Act but alive under the 1969 legislation. This conundrum creates obvious practical difficulties for all doctors, donors, and donees. Even Section 46 of the Indian Penal Code, 1860 [Hereinafter, "IPC"] defines a 'death' in a way that does not necessarily include brain-dead individual. The consequence of such differences could be that when an organ is harvested from a brain-dead individual, this action might be legal under the Act, but will attract a penalty under the IPC if the 1969 law's definition is considered. This seemingly complex problem requires a simple solution - harmonising the definition of 'death' across these laws. This can be done either by including brain-stem death within the scope of Section 2(b) of the 1969 Act or by including a caveat in Section 2(d) of the Act which promotes an autonomous reading of the section and upholds the provided definition despite inconsistencies with other laws. Rectifying inconsistencies will make the donation procedure more transparent and ensure that doctors can perform their duties without the fear of having to face any penal action from the patient's family, and can in turn help enhance the number of DDODs.

An allied issue that is faced in the context of brain-stem deaths and DDODs is that of the declaration of a patient as 'brain-dead'. In the case of Dr. S. Ganapathy v. State of Kerala, it was argued before the Kerala High Court that hospitals were widely using apnoea tests instead of electrocardiogram tests to determine if a patient is indeed brain-dead. As per scientific studies, the former test is not reliable for the determination of brain death and should be seen as more of a confirmatory test. Hospitals looking to engage in malpractice in order to harvest organs for transplantation often rely on the former way of testing. The Court in that case recommended that the Central and respective State governments should issue guidelines in this direction to prevent any abuse of the inclusion of brain death as valid criteria for DDOD. There is no proof of any such directives being issued, and this must be urgently done. Furthermore, additional safeguards must be put in place in this regard. Presently, the only safety valve in this context is Section 3(6) of the Act which requires a board consisting of a registered medical practitioner in charge of the hospital where the brain death has occurred, an independent registered medical practitioner, and a neurologist or a neurosurgeon to certify a 'brain death'. To strengthen the underlying objective Section 3(6) further, we can look at the recommendations made by the Malaysian Medical Council in this context. For instance, doctors who are involved in particular organ transplantation should not be involved in the process of certifying brain death for that case to avoid any bias or personal motives. Additionally, guidelines for determining brain-death should be reviewed every 5-10 years to accommodate contemporary scientific developments. This will ensure that outdated procedures such as the apnoea test are no longer used.

Now, once an individual is declared brain-dead, how do they consent to organ donation? If they have not expressed such consent while they were still alive, then the decision is taken by their next of kin as per Section 3(3) of the Act. What is lacking in our legal structure, is a mandatory standardised hospital procedure for obtaining consent from family members for DDOD. In this context, it becomes imperative to discuss the concept of decoupled requests for consent. What this concept essentially means is that families should never be informed about their relative's brain-stem death and be presented with the option to donate a part of one single conversation. Instead, these two bits of conversation should be decoupled or separated. A study conducted in the USA found that 61% of families agreed to DDOD when they were first informed of their relative's death, and then requested for organ donation in a separate conversation as compared to 44% when the families were informed and requested in the same conversation. By incorporating such a protocol within our legal framework and issuing directives to hospitals to implement the same, the Central and State governments can effectively help boost the number of DDODs.

Supplementary Measures

While filling the gaps in our existing laws will go a long way in ensuring a robust organ donation framework, this certainly cannot be the sole measure to be taken in this regard. More importantly, we need to identify a significant reason behind the low percentage of DDODs – misinformation, and stigma. Now, Section 12 of the Act mandates the explaining of risks, effects, etc. of organ donation to the donor before the removal of the organ. However, the deeper issue is that many people do not take the step of going to the hospital and talking to a counsellor because of their preconceived and possibly false notions of the dangers associated with organ donation. Both the Central and State governments need to step up and organise more public awareness campaigns to overcome this. Awareness could be spread through information booklets which clearly delineate the complications involved in a particular surgery. For example, in Scotland, the National Health Services issued one such booklet for liver donors. Another way to approach this problem would be to maintain a central or state-wise database on the outcomes of different organ donation surgeries to better help donors make an informed decision.

The legislative framework surrounding organ donation in India, while comprehensive, possesses several pitfalls, especially in relation to DDODs. The consequence of such pitfalls can be seen in the low number of donors vis-a-vis potential patients that we experience every year. Incorporating the suggested changes in the text of the law, and developing standardised protocols accompanied by social awareness measures will go a long way in strengthening India's organ donation system.

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