I. Abstract:
This research paper explores the regulation of organ donation with a comparative analysis of policies in India and global perspectives with a focus the importance of organ donation and transplantation. The objective of the paper is to provide a comparative analysis of the issues that the organ donation phase is facing. The paper examines five key subtopics:
(1) Importance of Organ Donation
(2) Types of Organ Donation
(3) Law governing Organ Donation in India
(4) Why Organ Donation in India needs big reforms?
(5) Organ Donation Globally
The study begins by examining the importance of organ donation. Organ donation is the process of donating a part of organ to someone who is in need of a organ transplantation. The organ transplantation can be done by a alive human as well from a deceased person. Organ donation is a life-saving machine where the donor actually saves the life of the recipient and provides a second shot in life. Organ donation has its own legal frameworks, where it is mandatory to be followed before donating a organ.
However, in organ donation there is a polarity that exists between the supply of organs and demand of organs, which eventually leads to a loss of many lives. In the past two decades, the number of organ donation and transplantation has gradually increased and also has provided an excellent result in the growing generation.
II. Introduction:
Organ donation has a stir up medical practice, providing a ray of hope to the patients those who are suffering from end-stage organ failure. Basically, Organ donation is the undertaking of giving an organ or a part of an organ to a person who needs a transplant.
Organ donation is a life-enhancing gift, that one can offer to other in order to save their lives. It is a selfless and compassionate act aimed at saving or improving the life of another individual. Organ donation can involve the donation of any vital organs such as the hearts, lungs, liver, kidneys, and pancreas, and as well as tissues such as corneas, skin, bones, and tendons.
The process of organ donation typically occurs after the donor has died, although living individuals can also donate certain organs or tissues, such s a kidney or a portion of their liver. Organ donation provides the patience with the opportunity to live longer and more fulfilling lives. Organ donation has the potential to make a profound impact on individuals and their families, offering hope and a second chance at life. It relies on the generosity and altruism of individuals who choose to register as organs donors or express their wishes to their loved ones. By donating their organs, individuals contribute to the advancement of medical science and the betterment of society as a whole.
As like Organ Donation, there’s also Tissue Donation. Tissue donation is a process of fetching or get hold of tissues from living human or a deceased person called the donor. The Medical field has made a huge progress in the donation and transplantation phase in recent times. When a person is deceased, the organs that are donated by the deceased is capable of saving upto 9 lives and improvise the lives of many others.
III. Research Methodology:
To get a clear view and idea on the factors regarding the Organ Donation and Transplantation.To achieve the objectives of this research paper, the research involves a comprehensive literature review to gather information from existing scholar works, reports, and relevant legal aspects. This paper is eloquent in nature and is based on regulation of organ donation on both national and international level. The secondary sources of information are sourced from journals, textbooks and websites for the research paper. This research paper aims at bringing out the rights which the donor and receiver exercises.
IV. Literature Review:
This section provides an extensive review of the existing literature on organ donation regulation, encompassing studies from India and globally. The paper examines the ethical considerations surrounding organ donation, regulatory mechanisms employed in different countries, the impact of legislation on organ procurement and allocation, and the challenges faced in implementing effective regulations. The literature review aims to identify best practices and potential areas for improvement in organ donation regulation.
The concept of organ donation and transplantation has numerous examples in Hinduism. A tribal hunter named, Kannapa, was a faithful follower of Lord Shiva. Once the priest at the temple objected to accept his offered meat to Shiva Linga. Lord Shiva wanted to the test the extent of Kannapa’s faithfulness. Lord Shiva made blood pour from the right of the Shiva Linga. The tribal hunter tried to treat with all his possible herbs, but then failed at the end. He, later then gashed out his right eye and used it to cover the wound that’s been bleeding. Then later the left eye began to bleed. Kannapa was above to gash out his left eye when he was stopped by Lord Shiva. It is a paramount act of devotion by donating a part of oneself.[i]
“I’m blessed. I have a 13-year-old girl’s eye and a 14-year-old boy’s eye. I’ve been given the gift of sight by people who decided to donate organs. I try to do as much organ-donor work as I can. “– MANDY PATINKIN.[ii]
In the case, Neha Devi v. Govt. NCT Delhi. The facts were that the petitioner wished to donate her kidney to her father, who required a transplant. However, the hospital and the doctor wanted a no objection certificate from the petitioner’s husband to process with the kidney donation.[iii]
Yashwant Varma, J. of Delhi High Court intended the correct reading of Rule 18 and 22 of the Transplantation of the Human Organs and Tissues Rules, 2014 and clarified that the rules did not examine nor compel spousal consent. The only requirement was the consent of the individual and approval of a person other than the beneficiary. It was held by the court that the consent of spouse is not a mandatory requirement for organ donation under the Transplantation of Human Organs and Tissues Act, 2014.
V. History:
The very first organ donation was done in the year 1954. The first organ donation was done by Mr. Ronald Lee Herrick when he donated his kidney to his identical twin brother. The procedure was conducted by Doctor Joseph Murray and he was also awarded the Nobel Prize in physiology or medicine in 1970 for his success in organ transplantation.
In the year 2015, a new born baby became the first and youngest child to donate organ. The baby donated his kidney to an adult with renal failure. The baby lived for 100 minutes after being born before donating.
The oldest donor was a lady in Scotland aged 107. She donated her cornea after her death in the year 2016.
The oldest donor for an internal organ was 95-year-old gentlemen from West Virginia. He donated his liver after his death.
In the year 1966 first kidney and pancreas transplant were performed.
In the year 1967 first liver transplant was performed.
In the year 1968 first successful isolated pancreas and heart transplant was performed.
In the year 1981 first heart and lung transplant were performed.
In the year 1983 first single lung transplant was performed.[iv]
VI. Importance of Organ donation:
The field of organ transplantation presents unique challenges that necessitate stringent regulations. Organ donation involves the complex interplay of medical, legal, ethical, and social factors. The scarcity of organs, the potential for commercial exploitation, the need for fair allocation, and the ethical considerations surrounding organ procurement pose significant challenges to healthcare systems worldwide.
Every year, 13th of August is celebrated as Organ Donation Day in India and globally. The person who donates organs are called donor and the one who receives is called recipient. In the year 1954, kidney was the first human organ that was to be transplanted successfully.
By the current situation around the globe, the U.S., system for organ donation and transplantation is said to be the best among every other country. The innovation and improvement helped the U.S., to upgrade and the number of donors and for the recipients to receive the greatest gift of life.
When a donor agrees to donate, the donor not only gifts the life of a recipient but also gives the best gift to all the recipient’s families, friends, relatives and everyone around. Organ donation plays a major role in saving lives. Organ donation and transplantation also gives the new lives to the ones suffering from organ failure. Organ donation also allows the recipients to live a longer life and make their life in very much upgraded. Donors must indicate their families and friends to donate their tissues and organs.
When an organ donation or transplantation is done, it often results a second shot at life. Organs such as hearts, pancreas, livers, kidneys, and lungs can be transplanted to the ones who’s been suffering from any organ failure. Other donations like Cornea or tissue transplantation means being able to get a new vision and a painless life.
VII. Types of Organ Donation:
I. Living Organ Donation
II. Deceased Organ Donation
I. Living Organ Donation- Living Organ Donation is when an organ is recouped from a healthy living person and transplant it to the one who is suffering from end-stage organ failure. Living Organ Donation is popular among the kidney or liver failure types as the liver can grow back to its normal size and as well the donor can survive with one kidney.
Living Donors can be either a near relative or a distant relative or a friend of the recipient. The near relative can be the recipient’s own spouse, daughter, son, brother, sister, parents, grandparents and grandchildren.
People other than the near relatives i.e., their distant relatives and friends before donating any organ are supposed to get permission from the State Authorization Committee to donate Organs. If the hospital is not ready to accept any organ donation from the patient’s distant relatives or friends, the patient can send a legal notice to the respective hospital for not following the Transplant Act.
Deceased Organ Donation- When the discussion is about donating your organ after death, the discussion is about deceased organ donation. Organs that is being donated after death of a person, is said to be deceased organ donation. But a common thought that most of the Indians have is that they can donate organs after their death but the truth is that the organs of a deceased person can be donated only in cases of Brain stem death. In the Western countries, donation after cardiac arrest is common, but in India it is very rare for a donation to be done after a cardiac arrest.
After death, all the organs and tissues that are within reach and in function can be donated. The deceased person’s organ will first be kept on a ventilator after she/he has been declared brain-dead. The organs will be kept in ventilator until all the necessary approvals are taken. The function of the organ of a deceased person may vary from a range of few days to a few weeks. The longer it takes, the more will fall inside the body. The families need to make their decisions quick for this reason.
Heart and lungs can be kept for 4-6 hours, Liver can be kept for 6-12 hours, Kidney up to 30 hours, Intestine 6 hours, Pancreas 6 hours.[v]
VIII. Law Governing Organ Donation in India:
The Transplantation of Human Organs and Tissues Act, 1994 is the law that was brought in by the Parliament of India on regulation on donation and transplantation of tissues and organs with an alive or deceased person. The act was introduced by the Health Minister and Family Welfare on 4th February 1994. The act is applicable to all the State Governments that adopted. But the act shall be applied to all the Union Territories.
The main objective of the Transplantation of Human Organs and Tissues Act, 1994 is to prevent all the commercialisation and illegal donations of organs or tissues. Under this act, any person working with relevance to organ or tissue donation without any authority, shall be punishable with a imprisonment of three years and a fine of five lakh rupees.[vi]
The Transplantation of Human Organs was amended in the year 2011, which allowed swapping of organs and also included that grandparents and grandchildren are free to donate. The amendments further had that
(i) Brain Death certification board has simplified and many people were permitted for the certificate.
(ii) Removal of Eye for eye donation shall be done by a trained technician.
(iii) National Registry of donors and recipients.
(iv) Near relatives included grandparents and grandchildren.
(v) It is mandatory to inquire and inform to donate in case of brain stem death of an ICU patient.[vii]
IX. Why Organ Donation in India needs big reforms?
(i) Low Organ Donation Rules- India faces a shortage of organs for transplantation due to low donation rules. There is a lack of awareness and understanding about organ donation among the general public, leading to hesitancy and misconceptions. Reforms should focus on raising awareness, educating the public, and dispelling myths to increase donation rates.
(ii) Organ Trafficking and Commercialization- Organ trafficking and the commercialization of organs remain significant concerns in India. Unscrupulous practices, such as illegal organ trade, exploitation of vulnerable individuals, and the transplant tourism, undermine the ethical principles of organ donation. Reforms should strengthen regulations, improve enforcement, and increase penalties to combat organ trafficking and prevent the exploitation of donors.
(iii) Legal and Regulatory Framework- While the Transplantation of Human Organs and Tissues Act provides a legal framework for organ transplantation in India, there is a need for further reforms. The legislation can be updated to address emerging challenges, streamline procedures, enhance transparency, and ensure effective oversight. Reforms should also consider simplifying the process of obtaining consent for deceased organ donation and improving the deceased organ retrieval infrastructure.
(iv) Donor Family Support- The families of the deceased organ donors often require emotional and psychological support during the organ donation. Reforms should include provisions for compressive support services to donor families, such as grief counselling and follow-up care. Recognizing and appreciating the contribution of donors and their families can also help create a positive environment for organ donation.
(v) Public-Private Partnerships- Engaging the private sector and forging partnerships between government agencies, healthcare institutions, and non-governmental organizations can help drive reforms and facilitate the organ donation process. Public-Private collaborations can bring together expertise, resources, and innovation to address the challenges associated with organ donation in India.
X. Organ Donation Globally:
The organ donation regulation differs from country to country and region to region globally. In most of the countries, the principles of organ donations are based on altruism, voluntariness, and non-commercialization. Different countries have different legislations for organ donation.
Organ donation is a critical global issue that has far reaching implications for healthcare systems and individuals in need of life-saving organ transplants. The demand of Organs surpasses the available supply, resulting in prolonged waiting times and a significant loss of lives worldwide. Addressing organ donation on a global scale requires collaboration, education, and advocacy to overcome all the challenges and increase the number of organs available for transplantation.
A major challenge in organ donation and transplantation globally is the legal and ethical considerations surrounding the process. As mentioned, different countries have different legislations and regulations on organ donation and transplantation. The different legislations may also include other consent requirements, donor registration systems, and the allocation of organs.
In the United States, the organ donation and transplantation is regulated by the Organ Procurement and Transplantation Network (OPTN) and the United Network for Organ Sharing (UNOS). The United States regulates an opt-in system, where the citizens shall actively register as organ donors. It can be assured through driver’s license designation, state registry enrolment, or signing a donor card. The act abolishes sale of organs and tissues for transplantations.
In the European Union, the organ donation is regulated and governed by the EU Directive on the quality and safety of human organs intended for transplantation. The directive establishes common standards for organ donation and transplantation and also abolishes the sale of organs for transplantation. The EU incorporates a mixture of consent systems. Absolute goal of the EU is to increase the number of donors. [viii]
XI. Suggestions:
(1) Large-scale awareness building- Number of donations are low in number, if it has to be increased the number of awareness programmes conducted should be increased.
When an awareness programme is conducted on a large scale, it can only be funded by the government. Government should take severe steps to conduct awareness programmes. It is not mandatory that the awareness programme to be only in physical form but can also be in forms of video, public posters in hospitals and a lot more.
The large-scale advertising campaigns basically aims at educating people about the pros of organ donation. It also aims at clearing all the myths and misconceptions that are surrounded across the globe on organ donation.
The advertising campaigns on organ donation can be made through all medias such as TV, print, radio, social media, celebrity endorsements, theatre and street plays, colleges, corporate offices and clubs.
(2) Setting up of a national registry and a centrally managed organ donor recipient- A central organ sharing or a recipient registry should be made an absolute mandatory to make sure that the donated organs are shared in a fair and transparent manner. The initiative of setting up a national registry and a centrally managed organ donor recipient has already been taken by the Transplantation of Human Organs Act, which has made a provision for this before. But the system has not been enforced yet. As there is no proper regulation on this yet, it leads to wastage of organs which is a actual shame when the family has decided to take a courageous move of donating organ.
The agencies concerned shall be recommended to look into the practices and policy measures taken over by states like Tamil Nadu and Maharashtra. This can enable them to build a model that shall be implemented in other states and countries.
(3) Make brain death declaration mandatory- Making brain death declaration mandatory may peak the reality of organ donation. It can help the doctors, physicians and relatives on the discussion about brain death and organ donations. It can help the transplant coordinators and personnel from other department to interfere and convince the family on donating organ.[ix]
XII. Conclusion:
On a main note, donating organ is a precious way of making someone live even after they almost lose their lives. Organ donation is definitely a good cause that any human being can offer. Organ donation ensures a continued contribution of an individual towards society’s well being even after death. It is a lifesaving offer that we all can give another by donating organ and registering for organ donation. We all shall promote and create awareness to people on organ donation through various campaigns. It is the least we all can do and help saving people’s lives.[x]
Author- Yoga Varshini S
Sathyabama Institute of Science and Technology
[i] ITNNEWS, https://www.itnnews.co.in/indian-transplant-newsletter/issue22/Religion-and-Organ-Donation-339.htm#:~:text=In%20the%20chapter%20XII%20of,qualities%20of%20a%20true%20devotee.&text=%E2%80%9CA%20a%20person%20puts%20on,up%20the%20old%20useless%20ones.%E2%80%9D , 13 June 2023
[ii] MANDY PATINKIN
[iii] Neha Devi v. Govt. NCT Delhi, (2017) 3 SCC 462]
[iv] ORGANINDIA, https://www.organindia.org/overviews/know-organ-donation/ , 14 June 2023
[v] ORGANINDIA, https://www.organindia.org/overviews/know-organ-donation/ , 13 June 2023
[vi] WIKIPEDIA, https://en.wikipedia.org/wiki/Transplantation_of_Human_Organs_and_Tissues_Act,_1994 , 13 June 2023
[vii] VIKASPEDIA, https://vikaspedia.in/health/organ-donation/transplantation-of-human-organs-act-1994 , 13 June 2023
[viii] LEGAL SERVICE INDIA E-JOURNAL, https://www.legalserviceindia.com/legal/article-10827-regulation-of-organ-donation-addressing-ethical-legal-and-practical-considerations-in-india-and-globally.html , 13 June 2023
[ix] ORGANINDIA, https://www.organindia.org/recommendations-future-strategy-action-plan/ , 14 June 2023
[x] BYJU’S, https://byjus.com/cbse/organ-donation-essay/ , 14 June 2023
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