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Overview Of The Transplantation Of Human Organs (Amendment) Act, 2011 And The Exigency To Amend It

The emergence of medical science has led to numerous crucial breakthroughs and inventions and certainly one of them is organ transplantation. It is an approach of extracting an organ from the body of one person (donor) and surgically placing it in another person's (recipient's) body for medical purposes. Organs that have to date been successfully transplanted include but are not limited to the heart, kidneys, and liver. Tissues incorporate bones, tendons, skin, nerves, veins, etc.

Blood doesn't come under the ambit of tissues insofar as tissue donation is concerned. Human organs can be extracted from the body of living, brain-dead, as well as people who died from circulatory death. Tissue may also be retrieved from donors who die of any of the aforementioned deaths for up to a day after the termination of the heartbeat. Unlike organs, most tissues can be maintained and kept for up to five years. Tissues are stored in tissue banks.

Transplantation of organs and tissues raises several bioethical issues, such as the definition of death, payment for organs for transplantation, and when and how consent for an organ to be transplanted should be given. Some other moral issues comprise transplantation tourism and more broadly the socio-economic context in which organ procurement may ensue. Further, the problem of organ trafficking and commercial dealings also arises. Another moral issue is not to deliver false hopes to the patients and their near relatives.

Since the inception of the 21st century, there have been roughly 2,200+ lung transplants executed each year all over the world. Notwithstanding India is the 3rd country in the world, after the US and China, in terms of the total number of transplants done in a year, there's a significant gap between the number of people who need a transplant and those that end up getting one here.

According to an estimate made by the Directorate General of Health Services, around 1.8 lakh people suffer from renal failure every year but only 6,000 renal transplants are done each year. Also, the deceased donation rate in the country currently ranges from a tiny 0.05 to 0.08 per ten lakh population.

In India, the practice of organ transplantation is primarily governed by the "Transplantation of Human Organs (Amendment) Act" of 2011 It is also known as the "THO (Amendment) Act, 2011". The government of India legislated the THO Act in 1994 to deliver the regulation of removal, storage, and transplantation of human organs for therapeutic objectives and the prevention of commercial dealings in human organs. It was amended in 2011 to encourage deceased donation, permit donation from living persons who are near relatives, and swap donations but still there remain numerous shortcomings in the said act which are needed to be rectified to better implement it.

Since the chasm between the number of people needing a transplant and the number of people actually getting it is abysmally high and the current legislation fails to address some major aspects of the transplantations, therefore, it is unmistakable that spreading awareness and educating the people about this practice and its related aspects is imperative and for that, having unblemished legislation for the same is a pressing priority.

Overview Of The Act
It is a law passed to regulate the removal, storage, and transplantation of human organs and tissues for therapeutic purposes, as well as to combat the menace of human organ trafficking and to deter human organ trading and related activities.

Initially, the Transplantation of Human Organs (Amendment) Act of 2011 applied "to the whole of the States of Goa, Himachal Pradesh, and West Bengal and all the Union territories and it applies to such other State which adopts this Act by resolution passed in that behalf under clause (1) of article 252 of the Constitution"[i]. It is now adopted by almost all states and union territories except a few such as Andhra, which have their own similar laws.

Section 2(f) of the THO (Amendment) Act, 2011 talks about who can be a donor. Any individual over the age of 18 who voluntarily authorizes the removal of any of his or her organs and/or tissues for therapeutic purposes is called the living donor.

Section 3(7) of the act provides for the procedure of removal of organs or tissue or both from a deceased's body. After the death (brainstem death or cardiac death), anyone, regardless of age, race, or gender, can become an organ and tissue donor. Due to the obvious fact that a deceased can't provide consent, consent from a near relative or someone in lawful possession of the deceased is required.

If the deceased donor is under the age of 18, consent from one of the parents is required. At the time of demise, medical suitability for donation is also determined. Section 2(i) defines a near relative as a "spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson, or granddaughter"[ii]. The 1994 act didn't include grandparents and grandchildren under the ambit of "near relatives".

Section 4 of the act provides for certain cases where the removal of organs or tissues is impermissible. For instance, according to sub-section 2, "no authority for the removal of any human organ and tissue or both from the body of a deceased person shall be given by a person to whom such body has been entrusted solely for the purpose of interment, cremation or other disposals"[iii].

Also, medical authorities must register themselves under the act to carry out such practices legally. Failing to do so and carrying out transplantations without authority would lead to punitive consequences under section 18 of the act. While section 18 deals with unauthorized transplantations, section 19 of the act criminalizes commercial dealing in human organs, whereas section 19A provides for punishment for illegal dealings in human tissues. Doing so can lead to rigorous imprisonment and imposing heavy fines on the delinquent.

Section 11 of the THO Amendment Act of 2011 forbids any donor or person empowered to give authority for the removal of any human organ or tissue from doing so for any reason other than therapeutic purposes.

Section 12 states that:
"No registered medical practitioner shall undertake the removal or transplantation of any human organ and tissue or both unless he has explained, in such manner as may be prescribed, all possible effects, complications, and hazards connected with the removal and transplantation to the donor and the recipient respectively"[iv].

Section 13 of the statute talks about the creation of appropriate authorities by the center for the union territories and by the state government for the respective states for the purposes of the act. The said authority is bestowed with all the powers of the civil court trying a lawsuit under the CPC of 1908.

Some of the functions of the authorities are to "grant registration under sub-section (1) of section 15 or renew registration under sub-section (3) of that section"[v], "to suspend or cancel the registration under sub-section (2) of section 16"[vi], "to investigate any complaint of breach of any of the provisions of this Act or any of the rules made thereunder and take appropriate action"[vii], to inspect tissue banks, etc. The act, when amended in 2011, also provided for a seven-member advisory committee to aid and advise the "appropriate authority" for a period of two years under section 13(A).

A tissue bank under section 2 (ob) means "a facility registered under section 14(A) for carrying out any activity relating to the recovery, screening, testing, processing, storage and distribution of tissues, but does not include a Blood Bank"[viii]. While section 14 talks about the registration of hospitals engaged in the removal, storage, or transplantation of human organs and tissues or both, section 14(A) provides for the registration of tissue banks.

If a person is dissatisfied with an order of the Authorisation Committee rejecting his/her application for transplantation approval, or any hospital or Tissue Bank, as the case may be, is dissatisfied with an order of the Appropriate Authority rejecting an application for registration or order of suspension or cancellation of registration, the aggrieved party, within thirty days of receiving the order of suspension or cancellation of registration, may file an appeal under section 17 of the act to the center or state government as the case may be.

The power to make rules on the act lies with the central government.

The Issue Of Organ Trafficking And Commercial Dealings

Organ trafficking is the illegal trading of human organs mainly for the purpose of transplantations. Even though notable efforts to restrict human trafficking for organ removal in India through enhancements to the Transplantation of Human Organs Amendment Act, 1994 have largely curbed organ trading, it is still a prevalent practice in India. The issue is still largely missing from the debates and discussions on crimes globally.

Organ trafficking is an unseen form of human trafficking that still continues in private transplant centers throughout India because in most cases, the legislation's implementation has been faulty, and its provisions have repeatedly been abused.

There are several nuances which are needed to be considered to examine the issue. Even if a transplant is financially feasible for someone, finding a matching donor is challenging due to certain obvious reasons like whether or not it is biologically possible to extract an organ/tissue from a particular donor's body and implant it in the recipient's body.

Furthermore, under the law, only a few people related to the person in need are authorized to donate, further reducing the number of potential organ donors. Consequently, people with their wealth and power entice poor people to sell their organs to them for transplantation. As per the World Health Organisation (WHO), every year, approximately 2,000 Indians sell their kidney.

Another factor that is needed to be considered is the fact that most of the victims of organ trafficking belong to the poor strata of the country. This can be attributed to the fact that deceiving, alluring, coaxing, and coercing them to donate their organs is a relatively easy task to do. Here is where the play of power comes. This in turn gets worsened because of the fact that these people are generally not provided with adequate post-surgery care.

Consequently, they become more prone to health complications and post-surgery trauma. The marginalized people, in their desperation, to get huge sums of money from selling their organs, keep a myopic vision and do not pay heed to certain serious aspects of post-surgery health hazards.

Another reason that can be attributed to the growing demand for purchasing human organs and further facilitation of illegal transplantation is the huge supply-demand imbalance for donor organs. This is evident from the following data-"about 50,000 persons suffer from heart failure annually but only merely 10 to 15 heart transplants are performed every year in India"[ix].

Apart from the numerous thought-provoking aspects highlighted above, the share of transplants that are performed with trafficked organs is also alarmingly high in India. "The WHO estimated in 2007 that organ trafficking accounts for 5-10% of kidney transplants performed annually across the globe"[x]. The problem at hand is a menace which is needed to be curbed and if not, will continue to prevail if the legislation is not implemented strictly.

Suggested Amendments To The Act
To keep up with changing times and developing technology, legislations are needed to be amended to match the contemporary scenarios and to suit the needs of society. The THO (Amendment) Act of 2011 also needs to be amended at the earliest. Following are some suggested amendments to the act:

Ceiling On The Cost Of Transplantation:
Even if a person needing an organ/tissue transplant finds a potent donor, an snag that hurdles the process is the skyrocketing cost of transplants, especially in private hospitals, even though the organ is obtained for free. "At present, private hospitals charge anything between Rs 10 lakh and Rs 30 lakh for a heart transplant, while for a kidney transplant the cost varies from Rs 5 lakh to Rs 20 lakh. In the case of liver, the price ranges from Rs 15 lakh and Rs 35 lakh"[xi]. An upper price limit is needed to be set by the government both for the government as well as private hospitals to ensure that profiteering is minimized.

Appellate body/tribunal
There is no proper appellate body that deals with appeals under the Transplantation of Human Organs (Amendment) Act, 2011. Even though section 17 of the act provides for the provision of appealing by the aggrieved party to the center or state government depending on the case, there is a need to constitute an appellate body like NCLAT (National Company Law Appellate Tribunal) and ITAT (Income Tax Appellate Tribunal) to unify the appeal system under the act and increase efficiency, thereby providing aggrieved parties with speedy redressal.

Stricter Punishment And Implementation
The prime reason for the failure of any law to fully achieve its motive is its flawed implementation and its less harsh punishment provisions. The fact that illegal transplants are still prevalent in the country points toward its improper implementation. The punishment provisions are needed to be harsher.

For instance, section 19 provides for punishment for the offenders of illegal dealings in human organs and provides for imprisonment of five years which may extend up to ten years. Imprisonment of just five to ten years for illegally dealing in human organs is disproportionate and less harsh. So there is a need to revisit the penal provisions of the act.

The lax attitude of the concerned authority should also be checked to ensure smooth implementation of the act.

Protection to donors
In most cases of organ trafficking, the buyers are rich and the organ donors are poor. The poor end up selling their organs in dire need of money and when caught, end up getting imprisoned for five to ten years which is unjust. Also, the consent form that the donors are required to sign does not consider problems like the use of force and deception, and proper monitoring of the whole process is rarely done. Penalizing poor donors in such cases is not humane. If done otherwise, they won't be able to seek help from the authorities without the fear of getting prosecuted.

Maintaining a proper online database
It is often seen that due to a lack of knowledge of the associated risks and hazards, people end up donating their organs and later regret it. To solve the problem, a proper online database informing the outcome of each transplantation and the health status of the donors should be maintained and made easily accessible through an application like "Aarogya Setu" for Covid-19. The same will also be fruitful for research purposes and medical practitioners.

Conclusion
The emergence of technology has resulted in numerous crucial developments in medical science that prove to be a lifesaver for millions of people globally. Such technological advancements, while potentially beneficial, may also be the source of illegal practices and exploitation. The same goes for organ transplantation. Even though it has saved thousands of lives, malpractices associated with it result in the exploitation of unprivileged people in society and the forming of organ rackets.

In a diverse and immensely populated country like India, having flawless legislation on any subject matter is very hard but adherence to the law and amending it from time to time may help in achieving its objective. Therefore, amending the THO (Amendment) Act of 2011 is needed to be amended at the earliest to make it unblemishd

End-Notes:
  1. Transplantation of Human Organs (Amendment) Act 2011, s 1(2)
  2. Transplantation of Human Organs (Amendment) Act 2011, s 2(i)
  3. Transplantation of Human Organs (Amendment) Act 2011, s 4(2)
  4. Transplantation of Human Organs (Amendment) Act 2011, s 12
  5. Transplantation of Human Organs (Amendment) Act 2011, s 15(3)(i)
  6. Transplantation of Human Organs (Amendment) Act 2011, s 15(3)(ii)
  7. Transplantation of Human Organs (Amendment) Act 2011, s 13(3)(iv)
  8. Transplantation of Human Organs (Amendment) Act 2011, s 2(o)(ob)
  9. Menaka Rao, 'India's law on organ transplants do little to protect rights of organ donors' (Scroll, 14 December 2014) accessed 11 September 2022
  10. Ashwaq Masoodi, 'Why organ trafficking thrives in India' (Mint, 28 May 2015) accessed 11 September 2022
  11. Preetu Nair, 'Organ is free, transplant cost is problem' (Times of India, 5 September 2016) accessed 02 September 2022

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