Organ Transplantation: Basic Knowledge; Legal Framework and Key Issues

The transplantation of an organ from one body to another is known as the organ transplant. The person who gives the organ is called the donor while the one who receives is called the recipient. Organ transplant is done to replace the recipient’s damaged organ with the working organ of the donor so that the recipient could function normally.

Who can donate organs?

Any person who is more than 18 years of age and is related to the recipient can donate organs after permission from the competent authorities. Organs that can be donated include kidneys, liver, pancreas, lungs and heart, while tissue constitutes eyes, skin, bone, bone marrow, nerves, brain, heart valves, eardrum, ear bones and blood. There are two ways for organs to become available for transplant. One is cadaveric in which within hours of the donor’s death, the organs are taken out, “harvested” and transported to the recipient. Another way is living organ donation in which a volunteer, usually a family member of the patient donates an organ or a portion of it for transplant.

Organ Transplantations in India:

Globally, Spain has the highest organ donation rate at about 34 donors per million, while India has nearly 0.03 donors per million. In India, Tamil Nadu has a highest number of organ donations.

India needs an estimated 6 lakh kidney donations annually, only 6,000 kidney transplants take place. The number of heart transplants is just inching close to 500.

National Organ and Tissue Transplant Organization (NOTTO) under the ministry of health and family welfare was setup in 2014 to oversee the process of Organ transplantation. Under NOTTO two organizations are present, namely, Regional Organ and Tissue Transplant Organization (ROTTO) and SOTTO (State Organ and Tissue Transplant organization)

Transplantation of Human Organs Act (THOA), 1994

The Transplantation of Human Organs Act (THOA), 1994 provides the legal framework around organ transplantation in India. This act regulates removal, storage and transplantation of human organs for therapeutic purposes and prevents commercial dealings in human organs. THOA is now adopted by all States except Andhra and J&K, who have their own similar laws. The THOA act was amended in 2009 to regulate transplantation of tissues of the body along with human organs.  The key features of this act are as follows:

Source of Organ

Under THOA, source of the organ may be:

• Near Relative donor
• Other than near relative donor: Such a donor can donate only out of affection and attachment or for any other special reason and that too with the approval of the authorization committee.
• Deceased donor, especially after Brain stem death

Other Points

Under this act Brain Stem death is recognized as a legal death in India. Organ donation from a person who is not a “near relative” requires permission of the State Authorization Committee.  Both the donor and recipient shall be penalized if convicted of commercial trade in human organs. The 2009 amended TOHA act expands the definition of “near relative” to include grandparents and grandchildren in addition to parents, children, brother, sister and spouse.

Issues and Challenges

Organ scarcity will grow rapidly in the coming years because of increasing life-span but there are number of challenges existed in organ transplantation. These are as follows:

• Under Article 246 of the Constitution, public health and hospitals are within the legislative competence of states which makes every state has its own transplantation laws.
• Demand versus Supply gap. A huge gap persists between demand and supply of organs in India. India has a donation rate of 0.5 per million which is one of the lowest in the world.
• Lack of Awareness of concept of Brain Stem Death among stakeholders and lack of awareness and attitude towards organ donation.
• Lack of Organized systems for organ procurement from deceased donor.
• The law in India provides that a non-relative donor can be considered only if one is willing to offer an organ out of “affection and attachment” to the donee, or for a special reason, but never out of consideration of money. Such a provision virtually blacks out the possibility of getting a donor.
• Though the TOHA law was envisaged with good intentions to ensure that the poor are not exploited but some stringent provisions in the law leads to illegal human organ trafficking.
• It became difficult to convince about the altruism of the donor to the Authorization committee.
• Currently, only half a dozen states have active organ donation programmes. Most have no infrastructure in place.
• A lot of people also believe that organ donation is prohibited in their religion which, in reality, is untrue.
• The growth and the rising popularity of social media has catapulted the illegal organ trade into a new direction.
• Majority of transplants in India are currently performed in the private sector.
• Living donation in India is often driven by gender. Less than 20% recipients are women, while 55-60% donors are women.

What needs to be done?

Organ trade in India like other problems such as child labor has a societal issue to it. It relates to the exploitation of the poverty-stricken people by alluring them with financial gains. Unlike other similar exploitative social situations, organ donation requires an invasive surgical procedure that has both physical and psychological implications.

• Bringing law for Voluntary donation of an organ in exchange for a minimum stipulated amount of money.
• India may adopt system of ‘opt out’ where organ donation will be automatic, unless an explicit request is made before death for organs not to be taken.
• There should be a uniform legislative policy to increase organ donations
• There should be a centralized regulatory authority with jurisdiction to monitor the transplantation procedures as the authority constituted under the Transplantation of Human Organs Act 1994 does not have pan-India jurisdiction. With a proper monitoring mechanism in place that would make the system open and transparent
• Transplantation activity could be established and promoted in the public sector.
• All transplantations must be registered in a national registry
• There must be a pragmatic procedure to record the will or pass on the message to the concerned authorities the directive of a person who wants to donate organs after death. This will ensure timely retrieval of organs.
• Though there are existing rules for the organ transplant system in the country, stricter implementation is the need of the day.

Some of the initiatives taken by government

The Central government had announced plans to set up a fund for families of people who have donated organs after brain stem death. The fund will support the education of children of deceased donors as well as medical expenses of other family members. The Government is implementing the National Organ Transplant Programme (NOTP) to promote organ donation across the country. The ministry of health and family welfare is considering the inclusion of stepparents, step-siblings and extended family members in the definition of “near relatives” in the Transplantation of Human Organs and Tissues Act, 1994 with the aim of increasing the incidence of organ donation in India, and to discourage organ trading while ensuring that patients find donors.

Other information

Brain Death

Brain death is the irreversible and permanent cessation of all brain functions. In situations of brain death, a person cannot sustain his own life, but vital body functions may be maintained in an ‘intensive care unit’ for a short period of time. Such persons are kept on artificial support to maintain oxygenation of organs so that the organs are in a healthy condition until they are removed. Organs of such patients can be transplanted to terminally ill patients.

In India, a panel of 4 doctors has to declare you brain dead before organs can be harvested which are repeated twice in a time frame of six hours.

Opt-Out System

Recently, France adopted the opt-out system in organ donations. This is essentially a “presumed consent” system where it is assumed that a deceased person has agreed to donate their organs unless they have added their name to a national “refusal register”. Spain also has the system of ‘opt out’ where organ donation will be automatic, unless an explicit request is made before death for organs not to be taken.

Exam Topics

Prelims:

Definition of donor in organ transplantation as per India laws; Basic provisions of THOA

Mains:

(1) The opt-out system is prevalent in several countries where organ donation is automatic unless opted out. What may be social taboos and issues towards implementing such a system in India? (GS-I, Indian Society)

(2) The government had enacted the Transplantation of Human Organs Act (THOA) to prevent commercial dealings in human organs but still a large number of scandals involving medical practitioners and others in the kidney trade has surfaced periodically in every state in India. On this issue, the following questions may be asked:

1.  What other legislative, policy measures should be taken? (GS-I and GS-II
2. What are ethical issues around it? (GS-IV)