S.N.D.T.
Women’s University Law School
Organ Transplantation
(Science, Technology and Human Rights)
Seminar
Submitted By:
Manjula Chakravarty
S.Y. LL.M. (Human Rights)
Roll No: 02
Submission (Month & Year):
October, 2024
Under The Guidance of:
Adv. Violet Almeida
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ACKNOWLEDGEMENT
I would like to extend my sincere and heartfelt thanks towards all those who have
helped me in making this project. Without their active guidance, help,
cooperation and encouragement, I would not have been able to present the project
on time.
I extend my sincere gratitude to my principal Mr. Rajesh Wankhede and my
professor Adv. Violet Almeida for giving me the opportunity to prepare this
project and provide their support and guidance.
I also acknowledge with a deep sense of reverence, my gratitude towards my
parents and other faculty members of the law school for their valuable
suggestions given to me in completing the project.
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INDEX
Sr. No. Content Page No.
1. Introduction 4
Historical Background 5
2.
3. Human Rights Implications of Organ Transplantation 6
4. Regulatory Bodies 7
5. Legal Frameworks and Ethical Concerns 8
6. Ethical And Human Rights Challenge 9
7. Current Scenario in India 9
8. Conclusion 11
9. References 11
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I. INTRODUCTION
Transplantation of human organs is a huge success in the field of medical science and
technology. In medical terms, ‘transplant’ is referred to as a process in which a portion/part of
the body or a complete organ is removed from its original site of an individual and transferred
to a separate site in the different individual.
However, the number of patients desperately needing a transplant outnumbers the number of
donors available, making it necessary for legislation to be in place to avoid illegal activity
involving the commercialization of organ transplantation.
Organ transplantation has proven to be a life-saving treatment for patients suffering from end-
stage organ failure. However, issues like organ scarcity, the illegal trade in human organs, and
the ethical considerations around consent, allocation, and donor protection have brought
attention to the human rights dimension of this medical procedure.
What is Organ Transplantation?
Organ transplantation involves the surgical transfer of an organ from a donor to a recipient
whose organ has failed or is damaged. Commonly transplanted organs include the heart,
kidneys, liver, lungs, and pancreas.
Technological Advancements:
• Surgical Innovations: Transplant surgeries have become increasingly sophisticated,
with improved precision and reduced risk.
• Immunosuppressants: These drugs, which prevent organ rejection, have been critical
in enhancing the success rate of transplants.
• Organ Preservation: Advances in cold storage and perfusion techniques have
increased the time organs can survive outside the body.
• Xenotransplantation: Research is being conducted to transplant animal organs into
humans, which could alleviate the shortage of human organs.
• 3D Bioprinting: Emerging technologies are exploring the potential of printing organs
using cells, offering the possibility of custom-made organs in the future.
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II. HISTORICAL BACKGROUND
Organ transplantation in India has a shorter history compared to the most developed countries
in the world. The Kidney transplant was first performed in India in the 1970s. Transplantation
activities picked up in the 80s and early 90s but it was mainly restricted to live donor kidney
transplants in selected urban areas. Slowly, with new clinics coming up and an increase in the
availability of trained staff, kidney transplantation activities increased. However, this led to the
famous kidney trade in India in the 80s which caught a wide media coverage. Foreigners’
patients started to flock to India for transplantation from a paid donor.
Considering the ongoing kidney scam in India, in 1991, the Central Government constituted a
committee to make a report, which would be going to be the basis of legislation governing
organ transplantation all over India. Moreover, it was also done to give a better definition of
the term ‘brain death’.
In 1994, The Transplantation of Human Organs Act (THOA) was promulgated by the
government of India. Moreover, the Transplantation of Human Organs Rules followed in 1995
and were last amended in 2014, increasing the scope of donation and including tissues for
transplantation. The act made commercialization of organs a punishable offence and legalized
the concept of brain death in India allowing deceased donation by obtaining organs from brain
stem dead person.
What is Brain Death?
Brain Death is referred to as a State where all the brain functions have stopped working and
cannot be reversed. However, in such a condition the heart may still be working due to the
presence of oxygen because of the ventilator. But the patient can safely be pronounced to be
dead in such a situation.
According to the definition in the THOA, brain death is a stage when all functions of the brain
stem have permanently ceased. The same has to be verified by the board of medical experts.
THOA Rules mention certain pre-conditions to be fulfilled by medical practitioners before
declaring a patient ‘brain stem death’. It has to be declared by the medical expert board after
they examine the body twice and at an interval of about six hours.
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III. HUMAN RIGHTS IMPLICATIONS OF ORGAN
TRANSPLANTATION
Right to Health and Equitable Access:
The right to health is a fundamental human right recognized by international agreements like
the International Covenant on Economic, Social, and Cultural Rights (ICESCR). This
includes access to life-saving treatments like organ transplants. However, there are significant
disparities in access to transplantation services based on geography, wealth, and social status.
Wealthier individuals can often afford faster access to transplants, while low-income patients
may wait for years or be denied access altogether.
Ethical Issues in Organ Donation:
• Consent and Autonomy: The foundation of ethical organ donation is informed
consent. Donors or their families must voluntarily agree to the donation without
coercion. In the case of deceased donors, the consent of the family or prior consent of
the donor is crucial.
• Living Donations: Living organ donors must give their organs willingly, without any
financial incentive or undue pressure. Coercion or exploitation, especially of vulnerable
groups, would violate their basic human rights.
Organ Trafficking and Exploitation:
The global shortage of organs has fueled an illegal market for organ trade. Poor and
marginalized individuals, particularly in developing countries, are often coerced or deceived
into selling their organs. This practice is condemned as a violation of human dignity and a
severe breach of human rights. International organizations, such as the World Health
Organization (WHO) and the United Nations, have implemented guidelines and conventions
to combat organ trafficking.
IV. REGULATORY BODIES
Advisory Committee
1. Constituted under the chairmanship of administrative expert, who is not below the rank
of the Secretary to the State Government for a period of 2 years to aid.
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2. Along with him/her, two medical experts possessing a medical postgraduate degree,
with not less than 5 years of work experience in the field of organ or tissue
transplantation.
3. Committee’s purpose is to aid and advise the appropriate authority (AA).
Authorization Committee (AC)
1. The purpose of this committee is to accept or reject the application of donors (other
than relatives) to ensure that he/she is not being exploited for monetary consideration
by making a donation.
2. The AC scrutinizes the joint application made by the donor and the recipient and
conducts an interview to ensure there is a genuine intention among them both and make
sure that the donor understands the potential risks of the surgery.
3. A hospital can have its own AC if they carry out more than 25 transplants per year.
Appropriate Authority (AA)
1. Appropriate Authority’s purpose is to regulate human organs:
• Removal
• Storage
• Transplantation
The hospitals can only perform these functions after being licensed by the authorities.
2. However, the procedure of removal of the eyes of a dead donor is not required and is
not governed by the authority and does not require licensing procedures.
3. The functions of the AA include:
• Inspection and registration of hospitals for transplant surgery,
• Enforcement of required standards for the hospital,
• Conduct regular inspection of the hospital to examine the quality of
transplantation and follow up medical care of donor and recipient, and
• Conduct an investigation for any breach of the Act.
4. The AA issues a license to a hospital for a period of 5 years and after that it needs to be
renewed. Each organ requires a separate license.
Competent Authority
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1. It means the head or committee made by the institute carrying out the transplantation.
2. Any member from the transplant team can be its member.
3. It gives permission for the near-related transplants only.
V. LEGAL FRAMEWORKS AND ETHICAL CONCERNS
National Laws on Organ Transplantation:
Different countries have varying legal frameworks to regulate organ donation and
transplantation. For example:
• Opt-in Systems: Countries like India and the U.S. require explicit consent from
individuals or their families to donate organs.
• Opt-out Systems: In countries like Spain and France, all individuals are presumed organ
donors unless they explicitly opt out. This system generally leads to higher donation
rates but raises ethical concerns about consent.
International Regulations:
Several international agreements and guidelines aim to regulate organ transplantation and prevent
exploitation:
• WHO’s Guiding Principles on Human Cell, Tissue, and Organ Transplantation: These
principles focus on transparency, non-commercialization, and protection of vulnerable
populations from exploitation.
• Council of Europe Convention against Trafficking in Human Organs: This treaty
criminalizes illegal organ trade and promotes ethical practices in organ donation.
Allocation of Organs:
Deciding who receives an available organ is an ethical dilemma. Allocation systems vary by
country but generally take into account factors such as medical urgency, time on the waiting
list, and compatibility between donor and recipient. However, disparities based on social and
economic status raise concerns about fairness and equity in access to organ transplants.
VI. ETHICAL AND HUMAN RIGHTS CHALLENGE
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1. Organ Scarcity and the Black Market:
The demand for organs far exceeds the supply, leading to a thriving black market in many parts
of the world. This market exploits the poor, who may feel pressured to sell their organs to
survive financially. International cooperation and stricter enforcement of anti-trafficking laws
are essential to combat this issue.
2. Consent and Exploitation:
The issue of consent is particularly sensitive in deceased organ donation. Opt-out systems can
sometimes be seen as violating an individual's autonomy if they are not fully aware of the law.
Living donors, especially in underprivileged areas, must be protected from coercion or
exploitation, as they may feel compelled to donate for financial gain.
3. Right to Life and Dignity:
The right to life and human dignity are central to the discussion of organ transplantation.
Donors must be treated with respect, and recipients should not have to resort to unethical
practices or suffer due to systemic inequalities.
VII. CURRENT SCENARIO IN INDIA
1. To do a diagnosis of a brain death donor, an ICU is required because it has the facilities
to sustain the other organ system of the patient. But the problem is, such ICUs are few
in number and are mainly located in big metropolitan cities. These are already
overburdened, unstaffed and lack a central command structure to function effectively.
So, on one side there is a patient who is dying, and on another who is already dead but
needs proper attention for successful retrieval of body organs. This situation
automatically makes the medical professionals give less priority to the brain-dead
patient.
2. The act of obtaining consent (informed consent) from relatives can be troublesome. The
doctor handling the treatment, might not be motivated enough to seek such consent
from the relatives. In other cases, the patients may lack relatives or their relatives may
not be present when the diagnosis of brain death is carried out. Although the Act gives
the right to the medical practitioner for the removal of organs for a donation if the body
isn’t claimed within forty-eight hours after death by its relatives. If the relatives of the
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person are traced after the duration and they object to the act, then it could be a huge
problem. Moreover, the decision of organ donation is not taken by a single relative and
the whole family may need persuasion which results in loss of crucial time.
3. Transplantation is a complex and expensive process and there is no state funding for
the same. It has been noted that most of the deceased donation has been taking place in
the private sector. Moreover, a large number of donors and recipients ae from private
hospitals. This is leading to an imbalance regarding accessibility, regardless of their
ability to pay, as the majority of the organs are currently going to the rich and the same
option is not available to the poor sector of the society.
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VIII. CONCLUSION
Organ transplantation is one of the biggest achievements in medical science and technology.
However, the fruit to this success may not be available to all. Cadaveric donation in India. in
its present form, largely benefits the rich and supports a tiny percentage of patients requesting
it. It also has led to the exploitation of the poor.
Therefore, though we actively aim to raise donation rates we must not lose sight of this big
picture. Many of the ideas and principles in modern transplantation of deceased donors come
from the developed West, where both social views and health systems vary from those in India.
we, in India, need to build an equal, open and not oppressive framework. This will be a slow
and challenging process, which may also entail linking to the bigger battle for an advanced and
accessible healthcare system for all.
IX. REFERENCES
WEBLIOGRPAHY
• [Link]
• [Link]
• [Link]
• [Link]
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