Laws regarding Organ Transplantation and Donation in India

Introduction:

Organ donation and transplantation seems to be the noblest or patrician work the man could ever do in his life, according to research a man can support about 6 people by donating organs. But it is essential to look upon the legal aspect of the matter as well, basically organ donation in layman language is when a person allows by his consent to use his or her organ removes and transplants into other human’s body. Talking about the legislation in India that governs this particular matter of organ donation is led under the Transplantation of Human Organ Act (THO), which was passed in 1994 to get organized and codify laws[1] about organ donation and transplanting activities. Before these laws were made, several cases have been recorded for the illegal sale of kidneys or pancreas etc. speaking about the positive side neither there was any law that supports organ donations and this is remarkable that with time and patience there was an improvement in parity of science, technology and law that organ donation of not only kidneys but other organs like liver, heart, lungs, and pancreas started.

Present Scenario of Organ Donation

There were many foundations and NGO’s came forward to promote the idea of organ donation but at the same time there were many cases recorded regarding illegal organ transplantation so, this has been clear in front of legislation of authority of India that country is in big need of law for organ donation, the various NGO’s came forward for the cause were, the MOHAN foundation the foundation was based particularly in Tamil Nadu and Andhra Pradesh and with its aristocrat work[2], NGO has eased about 500 of the 1,400 organ transplants that were performed in past fourteen years, so this is measured from a report that India currently has deceased organ donation rate of 0.05 to 0.08 per million population.

In sub-continent Asia, India was the country in the era of the ’70s to start the Kidney transplantation program. Initially, it has been focused upon to improve transplanting techniques and this took approximately 10 years and then there was a bit of rising in the cases of organ donation but at the same time, there was an increase in unrelated kidney donation in the poor section of the society as well. Looking upon the situations turning worse in next 2 years there was a burden from many sections of the society on the government to implement legislation on it which will make unrelated transplants illegal and the donation at the time of brain death has to be introduced so, then the legislation issued with the name, The Transplantation of Human Organ Act (THO). Focussing on the facts the last decade has been quite difficult on deceased or brain-dead organ donation programs in India, simultaneously there was also an increase in kidney scandals as well and cases where donors filed a case against the receiver for not getting the money or being compensated.

India has not seen much change even after enforcement of the THO Act; the reason could be non-implementation of the law as not even illegal trade or scandals stopped nor there increase in the number of donors who could take care of the social and medical problems. The concept that has been given importance by doctors of brain death has never given limelight or promoted. Through the study of several cases, it has been learned that various illegal scandals happen under the eyes of the Authorized committee.[3] And the few donations that were taking place are only because of the programs and documentaries prepared by NGO’s for the effective implementation of the plan. Due to recent condemnation and reproval by citizens and media of the country, the government has put the pressure to effectively analyze the loopholes of the present act and stop the illegal or unrelated organ donations[4] and this all couldn’t be possible until and unless we understand the fact that the act hasn’t been well implemented or understood by the hospitals and administrative authorities, so we need to focus on its implementation at the first stage.

Primarily for application of forms in organ donation, one must refer to the clearly stated various procedures in 13 different forms of table, some changes in Transplantation of Human Organs Act, 1994 were made by Central Government of India and later recognized it as Transplantation of Human Organs Rules, 1995.

Law and Rules Regulating Organ Donation and Transplantation in India

There are some important provisions mentioned in the THO Act, and of which many were amended in the new gazette as well:

A. Purpose of Living Donation

This provision defines the people who can donate without fulfilling any legal formalities. There were always mentioned about the relatives who can donate which are, Father, Mother, Sisters, Brother, Spouse, Daughters and Son. The donors need to prove their relationship with the patient by providing some legal documents or by having genetic tests as well. The new amendment that has been created in the gazette Grandparents are also allowed to donate. The recipient and donor also have to take permission from the committee organized by the government called the “Authorization Committee” and parties need to prove this as well that their motive to donate is noble and all things are done truly and affectionately.[5]

B. Purpose of Brain Death

The meaning of the term Brain death signifies or can be explained by the following standards as two certificates are required one of which would be from the doctors six hours aside and the approval of two doctors is much needed who are appointed by the Authorization committee one from them must have good experience and practice in a branch of Neurology.[6]

C. Transplant Activities

Transplant activities has been led by forming one Authorization Committee and an Appropriate Authority in every State as well as in Union Territories, they are assigned with specific duties [7]and work profile which are as follows-

1. Duties of Appropriate Authority: Authority is set up to govern the activities such as storage, removal, and transplantation of human organs. The transplanting activities are usually performed with the permission of authority. Although there are several operations where permission is not required such as eye donation, as it can be performed in hospital premises as well. There are various powers vested in the hands of the agency as to organize a time to time inspection and do arrange or grant permissions to hospitals so that they could perform such surgeries, inspect whether proper maintenance and hygiene protocols were followed or not, to make sure the protocols for surgery and requirements of equipment in surgery are maintained by the hospitals or not, also have the power to suspend or cancel the registrations and to organize proper report on complaints of breach or violation of any section of the act. Appropriate Authority is authorized by the act to grant 5 years and can renew that as well, this must be kept in mind that license for every organ will be different and can be grant to hospitals only with proper investigations.[8]
2. Duties of Authorization Committee: The committee’s role is defined from its name as it authorizes or finalizes as by approving or rejecting transplants between donor and recipients other than from the first relative. Whether one is approved for transplantation will be notified to hospitals via mails. The decision of allowing or not mentioned in Sub Clause (3), Clause 9 of Chapter II of the THO act. Other than this the basic duty of the committee is to check whether a donor is donating organs in the greed of money. It is the duty of the committee to arrange a personal interview with the donor and recipient to let the donor know all potential risks while donating his or her organs.

Procedure for Removal of Human Organ

Donors are authorized to donate any human organ of their body for curative reasons as specified in various Forms like 1(A), 1(B), and 1(C).[9] After the amendment, the forms have a bit changed and seem to be a bit comprehensive as it includes information like family pictures, address proof, marriage registration certificates, and a proper attested Notary. The official act states that whenever a human organ is removed before one’s death, the medical Practitioner or doctor performing the surgery must confirm whether the donor has given his consent in Form 1(A) if the one donating is a close relative like father, mother, son, daughter, brother, sister. The Form specified 1(B) is prepared for the spouse donating an organ and Form 1(C) is for other relatives.

This would be the duty of the Surgeon or Medical practitioner to check

• The donor has a proper health condition and has been approved by the committee to donate the organ. After verifying this registered surgeon or medical practitioner must sign the certificate as this is mentioned in Form 2.
• The donor must be a close relative of the patient or recipient as certified clearly in Form 3 and has signed Form 1(A).
• It is a necessary element that the donor needs to sign jointly Form 10 which states about the submission of an application and that the proposed application must be approved by the competent authority as well. It will be the duty of a Surgeon or medical practitioner to reassure himself and examine the relationship of donor and recipient.

This must be assured that if in a case recipient is the spouse of the donor, it must be clearly stated by the donor that they are so related which will be signified by signing Form 1(B) and then and application should be submitted with regard to Form 10 jointly with the recipient and then the donation criteria must be approved by the committee or the authority competent to do that. And if in a certain case donor is not a relative of recipient then in that case donor must sign Form 1(C) and then submit an application jointly with the recipient which will later by the proper investigation been approved by the authorized committee.

Duties of Medical Practitioner before removing a Human Organ after Human’s Death

• The donor basically in the presence of 2 or more witnesses with his free consent authorized Form 5 before his death, through which it will be depicted that removal of an organ of his human body is for noble or therapeutic reasons and also there will be no reason to believe that donor has later on revoked from consenting the matter.
• The specified person who will be in lawful possession of the dead body has signed a proper certificate as clearly stated in Form 6.

Duties of Medical Practitioner before removing a Human Organ in the case of Brain Death

• Importantly a certificate must be signed and issued by the Board of Medical Experts as mentioned in Form 8.
• If there’s a brain death of a person less than 18 years the certificate must be signed by all the members of Medical Board experts as mentioned in Form 8 and the certificate must be authorized and signed by either of the parents as well according to provisions of Form 9.

Whenever the question of interpreting the THO Act comes it has been always termed as flawed in terms of the Authorized Committee and several Medical Practitioners. But this has been amended and mentioned in the new Gazette but until and unless State governments make it compulsory this won’t take the required change. The more important aspect while interpreting this law is while focussing on provisions in Sub Clause (3), Clause 9 of Chapter II of the THO Act which states that “if any donor authorizes the removal of any human organs before his death under sub-section (1) of Section 3 for transplanting it into the body of a recipient, such organ shall not be removed or transplanted without prior approval of Authorization Committee[10]” this clause has been misused or misinterpreted a lot and various scandals were made using this section all over the years since this act has been passed.

There are several potential fraud cases has also been registered where there are instances of misuse of paid donor generally happens in cases of kidney donors[11] where the person whose kidney fails performing develops instant affection with strangers who’s in the position to donate his kidney in return of some need of money but the key point here is they deny for such information to AC’s. Later donors while not receiving a promised sum of money files their cases in police stations that they have been duped in processes and not paid as promised.[12] But here the stranger affections have no place in terms of law nor the eyes of AC. And when suddenly media exposes such cases Authorization Committees use to tighten and make laws of organ donation stricter that even unadulterated cases stop clearing or rests without being approved.

Conclusion

Concluding the matter, The THO Act despite being already passed 15 years ago wasn’t able to control illegal commerce trade in organ donation nor it helped society in promoting organ donation schemes and their importance. There’s a continuous increase in the gap between the number of patients and organs for donations worldwide. The increasingly high demand for organs made the illegal trading of organs more popular in countries where there’s more of the population is under the poverty line. And talking about India due to the increase in traffic accidents there’s an increase in the need for organs as well. Many hospitals have locked deals with NGO’s for promoting organ donation importance. At the end of the day, people need to analyze and interpret our law and need to make changes accordingly so that organ donation like a serious matter falls in the right hands and people could get benefit from well-established law. Meanwhile Centre and State Government must launch in parity various schemes that promote the idea of brain death and organ donation among people. And could also organize dramas, Nukkad acts etc. so that people could get aware of the importance of the matter and realize it as their social responsibility.

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[1] Government of India, Transplantation of Human Organs Act, 1994, Central Act 42 of [cited 2007 Mar 9]. Available from: http://wwwmedindianet/tho/thobill1asp.

[2] Karnataka’s unbaiting kidney trade, Frontline. 2002.

[3] The Bombay Experience with Cadaver Transplant—Past and Present Indian Transplant Newsletter.

[4] Gazette – Transplantation of Human Organs Rules. 1995. (GSR NO. 51(E), dr 4-2-1995) [As amended].

[5] Available from: http://www.easydriveforum.com/about_easydriveforum.php.

[6] Ibid.

[7] Ibid.

[8] Supra note 1.

[9] Available from: http://www.tn.gov.in/sta/tables.htm.

[10] Sub Clause (3), Clause 9 of Chapter II of the, THO act 1995.

[11] Goyal M, Mehta RL, Schneiderman LJ, Sehgal AR. Economic and Health Consequences of selling a Kidney in India. JAMA. 2002;288:1589–93.

[12] Shroff S. Working towards ethical organ transplants. Indian J Med Ethics. 2007.