PRESUMED CONSENT IN CADAVER DONATION: A HUMAN RIGHTS PERSPECTIVE
Updated: Aug 26
In The Light of Article 21 of the Indian Constitution
Status Quo of Organ Donation & Transplantation in India
India performs second-highest number of transplants in the world preceding USA; despite the mentioned achievement, there, unfortunately, exists a lacuna between the requisite number of transplants and available donors. Statistically, as per International Registry in Organ Donation and Transplantation, India has a dismal rate of 0.65 per million population (PMP) of ‘actual deceased donors’ in contrast to 33.32 PMP of the same in the USA. India records approximately half a million deaths annually due to paucity of requisite organs that otherwise would have been made available if we reconsidered our subsisting policy on organ donation. The appalling rate of organ donation has also attracted illicit activities like organ trafficking, which substantially contributes to the shadow economy per se, let alone infringement of basic human rights.
Nonetheless, potential donor attitude, infrastructure support services and organ donation awareness programmes occupy a considerable position in determining the rates. However, in order to improve the current state of organ donation rates, it is in the best interest to consider a reformation in the ongoing policy to bring the demand-supply imbalance to equilibrium vis-a-vis organs.
Method of Obtaining Consent: The Bone of Contention
Consent is a sine qua non to organ donation; as it forms the very foundation of the whole process. Policymakers have expressed varied views on the ‘consent’ of a person for the matter of donation. On a broad perspective, there exist two methods for determining ‘consent’ vis-a-vis cadaver organ donation.
a. Opt-in method, (Also known as ‘explicit consent system’) and
b. Opt-out method (Also known as ‘presumed consent system’)
The former promotes ‘individual autonomy’ by authorizing the removal of organs only on the individual's express and explicit consent for the matter; while the latter promotes ‘community interest’ by prima facie assuming the individual’s will to donate an organ(s) after his/her death. Having said that, the decision of the deceased donor in both cases is subject to objections made by his/her family members.
There is no rigid method of application of the two systems; it mostly depends on the country and its demographic conditions. However, in presumed consent system, the individuals do not have to go through the cumbersome process to register their willingness of making a donation after death, nor do they have to provide any evidence to prove that their consent is free from any coercive element. Whereas in countries practicing explicit consent system, like ours, requires individuals to prove their consent by filling numerous forms and affidavits to authorities. Although such hardships are necessary preventive methods against the proscribed sale of organs, it also dissuades one’s temperament to donate organs. Most countries with high donation rates have adopted the opt-out method; inter alia Austria’s donation rates quadrupled within 8 years of such a policy alternative being introduced. Spain has 49 cadaver donors per million population, which in fact is the highest score till date. The opt-out system thus serves in an advantageous manner.
Amid the conflict between individual autonomy and community interest, India has adopted the opt-in method. The governing principle of such policy in India provides independence and sovereignty to the individual's decision. That being said, the Delhi High Court reiterated similar fundamentals in the plasma-bank donation plea by not making it mandatory for patients recovered from COVID-19 to donate plasma for plasma therapy; which indeed was a plausible alternative if not a panacea.
Analysis of The Legislative Foundation of Organ Donation in India
The Transplantation of Human Organs Act, 1994 (the ‘Act’), read with Transplantation of Human Organs and Tissues Rules, 2014 (the ‘Rules’) form the legislative cornerstone of organ donation and transplantation in India. The scope of this article is exclusively limited to cadaver donation from a ‘deceased person’ as defined under section 2(e) of the Act. Additionally, ‘brain-stem death’ as defined under section 2(d) is considered a possible reason for ascertaining and declaring a body dead, although fit for organ donation. The donation, herein, is distinct from a regular organ donation. A regular donation would encompass retrieval of certain organs from a living human being, including organs like a kidney, a lung, a portion of liver etc. Whereas, cadaver donation provides a wider range of options since no vital organ is required by the deceased. For example, the heart of a donor can only be retrieved on his/her death.
Section 3(1) the Act authorizes organ or tissue retrieval from the cadaver (deceased’s corpse) for therapeutic purposes, i.e. the organs and tissues retrieved from the corpse are exclusively for treating and curing patients who are in need of a certain transplant. The Act does not encompass organ donation for ‘research purposes’. Furthermore, the individual shall, while living, express his/her explicit consent in writing and in the presence of two witnesses for removal of any organ or tissue or both. Whereas according to section 3(2) & (3) of the Act, contrary to the principle of self-authorization as mentioned above, the will of the donor is of no respect if the person in lawful possession has a reason to believe that the deceased has substantially revoked his authority to make a donation.
The decision of such a person, who is in lawful possession, shall be taken into consideration irrespective of the pledge taken by the deceased, thereby making the consent of the donor subjective to the approval of the person in lawful possession. In Common Cause (a Regd. Society) v. Union of India & Anr, the Supreme Court noted ‘right to die with dignity’ is an intrinsic facet of right to life under Article 21 of the Indian Constitution. The judgement reads “...Dignity in the process of dying is as much a part of the right to life under Article 21.”
To further reinforce, in Pt. Parmananda Katara v. Union of India and Anr, the Apex court observed that the right to dignity and fair treatment under Article 21 shall be available to a deceased as well. Emphasising on ‘fair treatment’, it is inclusive of the aspirations and wishes of a person pertaining to how their bodies are to be treated after their death. One may wish to donate his/her organs for therapeutic or research purposes or may pass away without doing so. However, discretion of the person in lawful possession contrary to either wish, would contravene the very fundamental and essence of Article 21 of the Constitution.
Subsequently, defeating the raison d'être of consent. In addition to this, the subsisting method of gaining consent has, time and again, had enough deteriorating impact by only making the availability of organs required for the needful recipients, worse. Taking observations made above into account, a pertinent question is posed below:
‘Will the proposed concept of presumed consent contravene the basic fundamentals of human rights involved inter alia right to die with dignity as mentioned under Article 21?’
Presumed Consent: The Road Ahead
Apart from tapering the widening gap between demand and supply of organs; incorporation of ‘presumed consent’ would also benefit in ensuring the right to die with dignity under Article 21, as earlier noted in the previous section. A variation of presumed consent is ‘hard opt-out’ system, according to this system if the deceased has not opted out from making a donation then, regardless of wishes of his/her relatives, it shall be considered that the deceased is now a potential donor. In fact, the countries adopting this system have observed a significant increase in organ donor rates by 25%.
The ethical, cultural and social issues of a country make it difficult to draw a uniform conclusion on implementation and outcome of presumed consent system. Brazil, for instance, has a large underclass with poor access to healthcare and adoption of such a policy caused distrust against the government. Therefore, the statute allowing presumed consent was repealed. Cultural and social issues primarily impact the collective thinking of a nation vis-à-vis treatment of the dead body, beliefs about the afterlife, and myths about the mutilation of corpse. India has a great diversity in religious as well as cultural practices; therefore adoption of the hard opt-out system may cause unfavourable intrusion in the lives of many people and their beliefs.
The issue of shortage of organs required for transplants was brought to notice of the Supreme Court in a recent case of Justice Saldhana vs UOI, where the petitioners via PIL pointed out the acute shortage of vital organs in our country and sought the direction of the court in making organ donation mandatory for convicts in death-row. The petition was dismissed by stating “organ donation is a voluntary act”, but for the sake of humanity, a nod of the Supreme Court on the matter could have set a precedent in the era of progressive and expanding medical jurisprudence.
The right to health is one of the internationally agreed human rights standard. In State of Punjab v. Mohinder Singh Chawla, the court incorporated the right to health as an integral part of the right to life, and the government has the constitutional obligation to provide health facilities. The primary responsibility of the government, in relation to the topic, is to ensure the availability of organs needed for transplantation. Any policy change would impact the daily lives of the people, let alone their ethical and religious concerns; but subsequently, it would mean betterment for the public health.
Albeit, the hard opt-out system ameliorates donation rates, but another implication of such a system is that every individual would be under the compulsion of making a donation. If a person wishes to opt-out from the process and wishes not to donate his organs, but due to some reason he could not fulfil the legal obligations required for doing so; in such a situation a rigid imposition of the hard opt-out system would prove to be counterproductive. For example, in case of ‘brain-stem’ death, it is impossible to record any expression of approval or disapproval, thereby assuming the consent of an individual in such a condition would cause panic among the medical as well as a legal fraternity.
Here, the subsisting policy of allowing family members to take a decision on behalf of the brain dead person shall help in improving donation rates. The scope of the decisiveness of family members or relatives must be limited to the situations where the individual is in no capacity of making decisions. This may also include the deaths caused due to skyrocketing rates of road accidents, due to which approximately 1.5 lakh set of organs and tissues go to waste.
Therefore, a combination of both the systems is suggested to be deliberated upon. If applied in isolation, either system cannot provide an appropriate solution.
The tug of war over the method of obtaining consent has fairly been on the side of the opt-in method, but the concept of presumed consent is not far-fetched and the day is not far when such a system would be deliberated upon by the policymakers, nationally and globally. Benefits of adopting such a system would not only suffice the availability of organs but also prove to be a viable solution in discouraging the black market of organs that takes a toll on the impoverished and the vulnerable section of our society. After all, it is the duty of the State to improve public health by virtue of Article 47 of the Constitution. Additionally, the government is pushing forward to review the existing parameters in the field, after the healthcare sector took a massive jab of the contagious virus COVID-19.
Title Image Source: dnaindia
The article has been authored by Moulik Shrivastava, who is a penultimate year law student at Hidayatullah National Law University. He finds himself inclined towards criminal law and human rights law. He likes to engage in conversations including various areas of politics, history and art.