Regulation of Donation of Organs in India and around World

Regulation of Donation of Organs in India and around World

The article, ‘Regulation of Donation of Organs in India and around World’ elucidates the nuances of organ transplantation and the rules, and regulations that govern them. The article will also enquire about the laws of different countries and the ethics involved in organ donation.


The process of organ transplantation entails taking organs from a donor and giving them to a patient who may be critically ill or near death from organ failure. The recipient of the organ’s life may be saved. By surgically replacing a patient’s faulty organ with a healthy one, organ donation can prolong a patient’s life by many years. People can give their organs when they pass away (dead donor) or while they are still living by giving a kidney or a portion of their liver (live donor). Sometimes the only treatment for long-term illnesses like leukemia or kidney failure is organ donation. One of the greatest achievements in contemporary medicine is organ transplantation.

Unfortunately, there are many more persons who need to donate their organs than there are donors. For instance, over 107,380 men, women, and children are in need of life-saving organ transplants in the United States, where 21 people perish each day while waiting for an organ. Everyone should think of themselves as possible donors. Based on their medical history and age, a person’s potential as a donor is assessed when they pass away. Medical eligibility for donation is determined by the organization that procures organs.

Since it is such a crucial subject matter, it is important to regulate these practices in view of restricting any unscrupulous or illegal practices in this domain. For this reason, different countries have set up different laws for the regulation and governance of organ donation.

The Laws Governing Organ Transplantation in India

Over 10 lakh individuals are waiting for corneal transplants, 50,000 are waiting for heart transplants, and 20,000 are in need of lung transplants in India, where the state of organ donation is deplorable. This is particularly regrettable given that an organ donor can, on average, save up to nine lives and provide 25 different organs to those in need. The transplant waiting lists in India are getting longer every day.

The Transplantation of Human Organs Act (THOA), 1994, which also legalizes the idea of “brain death,” the complete cessation of all brain activity, makes organ donation legal in India. While a person in brain dead cannot sustain life, the ICU is able to keep their important body functions going. These individuals are kept on artificial life support to keep their organs in good shape. This being the major legislation governing organ donation does not restrict each state from regulating the matter on its own terms under the aegis of provisions provided by this act.

Meaning to say, the subject of ‘health’ is governed separately by each state but regarding this matter, this Act forms the basis. Originally this Act was not very effective and cases of organ trafficking were detected which led to its amendment in 2011. The Act has established an Authorisation Committee and Appropriate Authority in every state and UT for the regulation of transplant activities. 13 types of forms are provided by the Act which lay down the procedures for various transplantations. Some of the rules of this Act govern aspects such as the removal of organs of a donor before his death after his consent for specific purposes mentioned in the Forms. So, all the major provisions of this Act cover the intricacies involved in organ donation.

The Laws Governing Organ Transplantation in Other Countries

Let us look at the laws for organ donation in other countries such as the U.S. and U.K. in order to understand their stance on this subject matter:


The Uniform Anatomical Gift Act (UAGA) is the main statute governing organ donation in the United States. The Uniform Agencies General Act (UAGA) is model legislation created by the uniform commissioners and then enacted state by state. The United States opt-in system for organ donation is established by the UAGA with gift law as its primary legal tenet.

The fact that a donation is made after someone has passed away means that there are no risks or advantages for the donor. Additionally, people typically give their consent for donation years or even decades before they pass away, thus it is impossible to predict what organs or tissues would be appropriate for donation at the moment of death. For these reasons, the legal framework of informed consent is inadequate for the control of organ donation. As an alternative, the UAGA’s legal foundation is provided by gift law.


The United Kingdom (England, Scotland, Wales, Northern Ireland) and the Crown dependencies of Jersey, Guernsey, and the Isle of Man all have separate legislation regarding organ donation. In England for instance, all adults are considered to have consented to organ donation when they die and the only exception is if they record an order stating their non-consent for donation. In Wales, ‘deemed consent’ is adopted where if a person has not registered his organ or tissue for donation, he has consented to donation.

Scotland practices ‘deemed authorization’ where if a person has not expressly provided his decision to be a donor or not, it will be assumed that he wants to be a donor. In this manner, the laws for organ donation in the U.K. are diverse and varied.

Ethics of Organ Sale

The country’s expanding middle class, lack of a universal health insurance program, widening wealth and income gaps, and, to some extent, the use of technology all contribute to the commodification of organs as a profitable business venture for some and a problem for others. Organ trade is a social issue in India, just as other issues like child labour and prostitution. It has to do with taking advantage of those living in poverty by luring them in with money rewards that, on occasion, can be significant and satisfy their short-term financial demands right away. Organ donation necessitates an intrusive medical procedure with both physical and psychological consequences, unlike other comparable exploitative social circumstances. Regulation of markets for human organs is one idea that has sparked legal and ethical discussion.

One well-known defence of this makes reference to the idea of human dignity. The selling of organs is said to violate human dignity. Making organs a commodity by caving to commercial pressures is risky, undermines social, moral, and ethical norms, and cannot be considered a viable solution to the issue of organ shortage in a civilized society.

WHO: Organ Transplantation

The World Health Organisation has, in a bid to further govern and regulate the concept of organ transplant and donation taken certain initiatives. Out of these initiatives are rules prescribed in ‘WHO Guiding Principles on Human Cell, Tissue, and Organ Transplantation’.

Over the past nearly two decades, these guiding principles had a significant impact on law, professional codes, and practices all over the world. The Sixty-third World Health Assembly issued resolution WHA63.22 on May 21, 2010, after several years of study, approving the revised WHO Guiding Principles and highlighting areas for improvement. The Guiding Principles are meant to offer a systematic, moral, and approving framework for the collection and transplantation of human cells, tissues, and organs for medical purposes. Each jurisdiction will choose how to put these WHO Guiding Principles into practice. The Guiding Principles place a strong emphasis on the need for documentation and openness, both for quality management and to support the trust that patients, doctors, and the general public have in donation and transplantation services.


A person’s life may be saved or completely changed through a transplant. More than ten people’s lives can be changed by a single organ and tissue donor. People who require an organ transplant are typically critically ill or near death as a result of one or more failing organs. They range in age from young children to the elderly. It is necessary for donors and their families to consent to organ and tissue donation after passing away. While organ donation is a nuanced subject matter which involves various intricacies and is embedded with issues that are of utmost importance, countries such as India have attempted to bring the same under a roof for better regulation and governance purposes.

India has enacted an umbrella legislation that covers almost all aspects of organ donation. But since the concept has a very large scope, there is no straight jacket formula that can be applied to every situation, and thus there is a need for constant evolution in this domain. Different countries have set up various laws in an attempt to ethically govern and continue the practice of organ donation in their jurisdictions. While the U.S. considers it to be a ‘gift’ the U.K. has a separate approach to the deemed consent and authorization in its different jurisdictions. All the approaches are distinct and efficient in their own way.


[1] Alexandra K. Glazier, Organ Donation and the Principles of Gift Law, Available Here

[2] Organ Donation and Transplantation, Available Here

[3] Legal and ethical aspects of organ donation and transplantation, Available Here

[4] Organ donation laws, Available Here

[5] Zumrut Alpinar Sencan, Holger Baumann & Nikola Biller-Andorno, does organ selling violate human dignity?, Available Here

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